CN114425106B

CN114425106B - Drainage device, drainage method and drainage device manufacturing method

Info

Publication number: CN114425106B
Application number: CN202011095444.XA
Authority: CN
Inventors: 蒋小平; 于奕飞
Original assignee: Yu Congjun
Current assignee: Yu Congjun
Priority date: 2020-10-14
Filing date: 2020-10-14
Publication date: 2024-03-29
Anticipated expiration: 2040-10-14
Also published as: CN114425106A

Abstract

The invention discloses a novel drainage device, which comprises: the drainage tube, the clamping balloon connected with the drainage tube, clamping balloon filler, communicating pipes, a locking device and a bracket tube movably arranged in the drainage device; at least one section of the drainage tube wall is a flexible tube wall. When the drainage device is in a non-drainage state, the flexible drainage tube body of the drainage channel has good shape following performance, small extrusion and expansion degree to tissues around the drainage tube and light local inflammatory reaction; when drainage is needed, the stent tube moves to the narrow part of the drainage channel along the inner side of the drainage tube wall, and the drainage process is completed. The invention also discloses a manufacturing method for manufacturing the clamping balloon, the drainage tube, the communicating tube and the related structures of the clamping balloon, the drainage tube and the communicating tube, wherein a basic pipeline is firstly manufactured, and then the basic pipeline is processed, combined and related accessories are configured. The drainage device of the invention also has a reverse conveying function, and particularly plays an important role in food conveying of the upper digestive tract.

Description

Drainage device, drainage method and drainage device manufacturing method

Technical Field

The invention belongs to the technical field of medical instruments, and particularly relates to a drainage device and a drainage method, and a manufacturing method of the drainage device.

Background

The purpose of medical drainage is to direct gases, liquids (including blood, pus, inflammatory exudates, bile, gastric juice, intestinal fluids, urine, secretions, etc.) that accumulate in a body cavity, joint, organ or tissue away from the site and out of the body to prevent accumulation in the body cavity or surgical field, secondary compression symptoms, infection or tissue damage. The disease change can be found early by observing the drainage condition; after blood, exudates, tissue exudates, gas and the like are drained, the aims of reducing local pressure, reducing the damage effect of the liquid or the gas on surrounding tissues, reducing the possibility of combined infection, being beneficial to maintaining normal physiological activities, promoting wound healing and the like can be achieved. In order to achieve the above purpose, various drainage tubes are often placed.

While draining the drainage material of the drainage lumen, it is in many cases necessary to introduce substances, such as various drugs, washing or rinsing liquids, foods, contrast agents for radiological examination, in particular such a reverse filling of the fluid may be performed earlier than the drainage process, such as an x-ray examination of barium administered to a stomach tube placed in the stomach, and if the digestive tract is found to be running unobstructed, without having to perform a gastrointestinal decompression drainage, the input foods, in particular the fluid foods, may be administered directly. The repeated administration of irrigation solutions or medications to the bladder is required during the course of treatment of some particular prostate or bladder diseases. Drainage gap drainage is drained while often requiring the infusion of drugs, which are typically in fluid form or carried by the fluid into the drainage gap, and in special cases may only require the infusion of substances into the drainage gap to accomplish the purpose. In this sense, the drainage device cannot solve the problem by simply conducting drainage, and has a function of inputting fluid substances, and in particular, the fluid substances can be repeatedly input through a narrow portion.

At present, a commonly known drainage tube is made of a high polymer material, and in order to maintain the smoothness of the drainage process, the drainage tube must maintain a certain rigidity to resist continuous or intermittent twisting, extrusion and traction of a drainage channel, and thus maintain the continuity and stability of a lumen in space. On the other hand, in order to enable drainage to be smoother, particularly when some liquid with high viscosity or particles or tissue clusters need to be drained, the drainage effect of the drainage tube adopting the lumen as large as possible is better and the drainage tube is not easy to block; however, a larger lumen under the same conditions means a greater force of twisting, squeezing, pulling on the drainage channel, which necessarily causes an increase in tension of the drainage channel and surrounding soft tissue, thus causing a decrease in local blood circulation, making local inflammation more likely, and a decrease in local resistance, thus easily inducing bacterial or fungal infection.

In clinical medicine, local discomfort and even pain after indwelling catheterization are typical examples, especially in old men, the prostatic hyperplasia often causes the prostatic distortion of the urethra, the increased urination resistance, the difficult urination, the intermittent and continuous urination process, and the treatment measures such as oral medicines, catheterization, prostate related operation and the like have to be adopted, and the indwelling catheterization is required to be carried out for a period of time to maintain the smooth urine passageway after the operation. The traditional catheter is a high-hardness polymer material pipe, although the surface of the catheter is soaked by liquid during placement, or various lubricating materials are coated on the surface, even the surface of the catheter of some manufacturers is subjected to various surface treatments and material coating in advance, so that the catheter is smoother and more tissue-friendly; however, the traditional catheter is of a circular tube structure, when the catheter is arranged, the internal mass and volume of the prostate capsule are increased due to the arrangement of the catheter, and the tension of the prostate capsule is increased as seen from the whole prostate; in the case of a part of the prostatic urethra, the wall of the catheter passing through the prostatic urethra cannot be matched with the twisted narrow urethra, which inevitably leads to that certain parts of the urethra and adjacent prostatic tissues bear higher tension than the average level of the whole prostatic gland, the damage caused by the tension and the reduction degree of local blood circulation are most obvious, the local damage is accumulated to a certain degree, the local inflammation edema is caused, the local edema is caused, the tension of the prostatic gland is greatly increased, the malignant cycle of the process leads to that the prostatic gland cannot regulate and control by itself, and the chronic inflammation state is brought into a long time. Furthermore, since the opening of the prostate is positioned at the prostatic urethra, the traditional urinary catheter is placed in the prostatic urethra with a twisted and narrow position, which inevitably directly or indirectly causes tension change to the opening of the prostate, and the soft tissue at the opening of the prostate is affected by the same tension damage and local blood circulation reduction caused by the tension damage, so that the inflammation at the opening of the prostate is caused, and the infection state of the prostate is caused.

Placing nasogastric tube is a very common treatment measure in medicine, because dysphagia water feeding difficulty, drainage gastrointestinal tract liquid and other conditions, needs to place nasogastric tube through the nasal cavity, also is used as a rigid polymer material pipe, and when nasogastric tube passes through the nasal cavity and the nasopharynx, the nasal cavity wall, the nasal turbinates and the nasopharynx are mainly cartilage and bone structures, the surface of the nasogastric tube is only covered by a small amount of soft tissues and mucous membranes, the deformability margin is small, the nasogastric tube is bent, the area of the stress point of the local structure is small when the nasogastric tube is bent, the stress of the bent nasogastric tube is concentrated in a small range, and the stimulation to the nasal cavity and the pharyngeal wall causes serious discomfort and damage to the nasal cavity and the nasopharynx. The same reason is that the nasal jejunum tube and the nasal bile duct cause the same discomfort and damage to the nasal cavity of the nasopharynx.

In addition, food is input below the pylorus, the food reflux risk is much lower, and when the drainage tube needs to be placed in the alimentary canal below the pylorus, the current common stomach tube cannot smoothly pass through the pylorus by a blind insertion method. In addition, in the case of pancreatitis, the fluid food is input into the alimentary canal below the dropsy ligament, which is more helpful for alleviating the pancreatic burden and being beneficial to disease recovery, and the alimentary canal below the dropsy ligament is difficult to be placed into the canal by a blind insertion method by using a general traditional empty intestinal canal.

The digestive tract tumor and inflammation develop to a certain extent, often cause intestinal obstruction of the patient, and the patient loses a channel for further taking nutrition from the digestive tract, so that the non-digestive tract nutrition increases infection risk and economic burden, and the nutritional effect is inferior to that of the trans-digestive tract nutrition. For upper digestive tract obstruction, the gastrostomy can be placed into the gastrostomy tube, and the jejunostomy tube can be placed to maintain food intake; for ileal and colonic obstruction, the problem of digestive tract obstruction is to be solved, common methods include the approach of fecal elimination through colo-or ileostomy and artificial anus arthroplasty, which is often not accepted in sensory experience, and a technique for oral, anal, or body surface puncture placement of a tube to solve the nutritional problem, while timely elimination of fecal matter is necessary.

When some pneumothorax needs to be catheterized and drained, the drainage tube needs to pass through a gap between two rib bones, because the drainage tube needs to be large in drainage quantity, the tube diameter belongs to the largest category of all traditional drainage tubes, the drainage tube needs to keep enough rigidity, and local discomfort is caused to local skin traction by the tube wall and the fixing suture, and particularly the discomfort is more obvious when the lying position is changed. Some patients can limit the placement of the body position even because of placing the chest drainage tube with higher hardness, thereby increasing the chances of skin compression at special parts of the whole body and increasing the possibility of pressure sores; when the illness state is stable gradually and the pleural effusion or gas drainage rate is reduced gradually, the setting of large drainage rate is not needed to be maintained, the originally placed pipeline is unsuitable, and at the moment, if the original large-caliber setting is maintained again, the discomfort of the patient is increased, and unnecessary local inflammation risks are born.

Certain organs of the body, such as the liver, form cysts that affect normal operation of the body when the cysts develop to a certain size, and puncture drainage is a solution, and previous methods include placement of a rigid drainage tube, which also has the disadvantages of drainage tube blockage and discomfort of the skin outlet.

After the onset of some suppurative diseases, in particular some chronic suppurative diseases, especially perianal abscess and late anal fistula, the infection locally has complicated sinus passages, and the local part comprises chronic granulation tissue, pathogenic microorganisms and necrotic tissue. The surrounding of the infection part is provided with important structures (such as anal sphincter), so that all necrotic tissues cannot be removed completely to achieve the primary healing goal, a drainage tube is often required to be placed in the operation, drainage is continued for a period of time after the operation, exudates, the fallen necrotic tissues and part of pathogenic microorganisms are drained, local tension is relieved, local blood circulation is promoted, and the purpose of delayed healing is achieved. Another situation is that the body is generally poor and cannot withstand complicated long-term anesthesia and surgical procedures, and doctors can simply treat the effusion site, and some are simple drainage tube placement procedures performed under local anesthesia. The drainage tube conventionally placed has the problems that the side hole of the pipeline is blocked and the drainage effect is reduced, and meanwhile, the contact stimulation of the common pipeline to the skin outlet can influence the use feeling.

Because chronic sinus tracts caused by microbial infection, physical and chemical factor injury, tumor, ischemia and the like are irregular, in some special cases, even surgery can only cut off most sinus tracts, the rest is complex, the traditional drainage tube has the problem of not being well matched with Dou Daoxiang, the local part of the sinus tracts has an excessively high-tension injury mechanism (as described above), and meanwhile, the sinus tracts are in a chronic inflammation state, the possibility that new and more extensive inflammation is induced is increased, and thus the healing process is affected.

In summary, maintaining the stability and smoothness of drainage is often required for treatment, the larger the tube diameter of the traditional drainage tube, the stronger the drainage capability, the less prone to blockage, but the larger the tube diameter of the traditional drainage tube, the larger the damage to the drainage channel, particularly to the drainage channel with irregular local stenosis distortion. The drainage capacity of the traditional drainage tube is contradictory to the damage to the drainage channel itself. The invention solves the contradiction between the drainage capacity of the drainage device and the damage of the drainage device to the drainage channel to a certain extent.

Disclosure of Invention

The problem underlying the present invention is to provide a medical device and a medical kit which facilitate the intermittent or continuous drainage of a drained gap as gently and efficiently as possible, thereby avoiding the drawbacks known in the prior art. More preferably, the medical devices and medical kits are particularly suited for use where drainage is required through a delicate area, such as the enlarged prostate, the gap between two ribs, inflamed skin or subcutaneous soft tissue, and inflamed muscle, nerve, tendon, and vascular bone tissue, accessible skin exit; preferably, the drainage channel is provided with a structure which is not easy to deform, such as a nasal cavity; preferably, the present invention provides a drainage device and a drainage kit that have lower local inflammation-inducing risk and higher efficiency and use comfort, suitable for drainage and perfusion of the alimentary canal away from the oral cavity site.

The medical device and the medical kit properly solve the problem, and in addition, the manufacturing method of the clamping balloon and the connecting structure in the manufacturing of the drainage device provides help for manufacturing the drainage device, and the invention also provides a preferred embodiment; in addition, the drainage method provided by the invention provides help for the implementation of the drainage device, and the invention also provides a preferred embodiment.

The underlying problem of the present invention is further suitably solved by a therapeutic device and a method of treatment for drainage as defined in the description.

The medical device according to the invention is particularly useful for drainage of various fluids, preferably liquids, in particular urine, which is stored.

The drainage tube cavity of the drainage device has no guiding structure which particularly limits the flowing direction of liquid, and the flowing direction of the liquid in the drainage device is controlled by the pressure difference of the liquid at the head end and the tail end of the drainage device, so that the drainage device has the function of inputting the fluid into the drainage cavity on the premise of not changing the structure of the drainage device. For convenience in explaining the structure and design concept of the present invention, the present specification mainly aims at the drainage process, and the input process opposite to the drainage process can be understood by the relevant professional in common sense.

The invention provides a drainage device, which comprises: the drainage tube, with the screens sacculus, the isolator, screens sacculus filler, filler fills and puts the annex, and, movably sets up the support pipe in drainage device, at least a portion of drainage tube includes flexible material.

Drainage refers to the medical use of tubing to transfer fluid substances to the outside of the body; perfusion is used for better drainage or therapeutic purposes, and uses the delivery of drugs, flushing fluids, nutrient fluids, etc. to specific lumens by means of tubing. In a specific implementation, one of the drainage or perfusion effects is often mainly, or even only one of the effects is utilized, and for the purpose of illustrating the bidirectional fluid transfer effect of the present invention, the apparatus or method of the present invention may be referred to as a drainage perfusion apparatus, and for convenience of description, the apparatus or method of the present invention is generally referred to as a drainage apparatus or drainage method; in one aspect, for better drainage, the drainage device in all embodiments can deliver flushing fluid and medicines to the drainage channel or the drainage cavity; in particular embodiments, for example, the main purpose of the gastric drainage tube during a certain period of time, even throughout its use, is to deliver nutrients, and in particular embodiments, separate input tubing applied to the drainage device is provided exclusively for the purpose of delivering fluid, for use in conjunction with a continuous irrigation treatment regimen. The drainage tube, the drainage device and the drainage method are equivalent to the perfusion tube, the perfusion device and the perfusion method under the condition of no specific description, and the drainage process or the drainage device are mainly described in detail in the specification for unification and convenience of description.

The drainage gap is a space where the drainage material gathers, and most of the wall of the space can generate the drainage material, or the drainage material can be conveyed from other places through a hole communicated with the drainage gap.

Drainage gaps include voids that the body itself has, such as the trachea, sinuses, stomach, esophagus, intestinal lumen, bladder, uterine cavity, vaginal vault, chest, abdomen, pelvis, renal pelvis, joint cavity, gall bladder, bile duct, pericardial cavity, ventricle and cysts that occur in various parts of the body; drainage gaps also comprise cavities caused by tissue dissolution absorption or detachment from inherent positions due to factors such as infection, trauma, tumor, ischemia hemorrhage, chemical injury and the like; drainage gaps also include the lacuna created by the disruption of the structural integrity of the body by surgical procedures performed to address the disease, such as tumor resection, orthopedic surgery, abscess debridement, organ transplantation, prosthetic implantation, and wound repair.

The drainage channel is a tissue pipeline through which the drainage substance leaves the body from the drainage cavity, and comprises the inherent pipelines of the body which are communicated with the outside, such as respiratory tract, genital tract, nasal sinuses, nasal cavity and alimentary canal, wherein the cavity and the body surface are provided with inherent openings under normal conditions.

The drainage channel also comprises a pore canal manufactured through operation, including a temporary pore canal or a permanent pore canal, such as a puncture drainage channel of stomach fistulization, jejunostomy, bladder fistulization and various body intrinsic cavities, and also comprises a non-body intrinsic channel caused by infection of tissues, chemical factor injury, tumor, ischemia necrosis, wound and operation; the artificial channel openings can be formed on the surface of the body surface or on the walls of various inherent drainage channels of the human body.

The interface between the drainage channel and the drainage gap is an inner opening of the drainage channel, the drainage liquid is conveyed out of the body, and the opening of the drainage channel on the body surface is an outer opening of the drainage channel. The boundary between the drainage gap and the drainage channel is more fuzzy under the drainage condition of some abscess sinus, for example, various abscesses gradually expand from the deep part to the skin to finally form an external port on the skin, the three-dimensional distribution of the places where pus is generated and gathered is complex, the clamping saccule is often placed at the farthest part of the pus cavity, or the place where the cavity gap is largest, the proper expansion of the distribution range of drainage holes of the drainage tube is beneficial to full drainage, and especially, the drainage tube section with a longer drainage tube section is arranged near the clamping saccule, and the distribution section of the drainage tube inlet covers the drainage channel capable of generating drainage matters as much as possible, thereby being beneficial to drainage of pus and necrotic tissue; in some special cases, even a plurality of drainage devices can be used for drainage.

In general, a narrow part in a drainage channel represents a part in the drainage channel for naturally flowing out of drainage liquid, such as a prostatic part of urethra, a sphincter part of urethra, an anal sphincter part of anus and intestine, a part of the drainage channel penetrating through fascia skin and the like, wherein the drainage channel is provided with a flexible material, and a lumen of the flexible material is often a potential lumen, so that the speed of the drainage liquid passing through is too slow along with the factors of the extension of the drainage channel, the rising of the viscosity of the drainage liquid and the like, and even if the drainage channel is in a normal and uniform tissue gap or channel, the situation also belongs to the narrow part of the drainage channel; particularly, under the condition that a negative pressure source is required to promote the flow speed of the drainage, the flexible pipeline from the drainage inlet to the interface of the negative pressure source is supported by the support pipe, the flexible pipeline cannot finish drainage operation under negative pressure, the drainage channel through which the flexible drainage tube under negative pressure flows also belongs to one of the narrow parts of the drainage channel, and the preferred value of the ratio of the length of the flexible pipeline to the length of the total drainage tube in the invention comprises 5-99%.

For the purposes of the present invention, all expressions relating to direction and relative position are uniformly arranged as follows. The left side in the legend represents the left direction of the reader and the right side in the legend represents the right direction of the reader. The left side represents the head side direction, the far side direction and the telecentric direction which are indicated by the legend, and the structure or the direction indicated by the "A" is positioned on the left side under the condition that the two structures are sequentially or successively indicated by the "A", "B" and the like in the legend; the right side represents the caudal direction, the proximal direction and the proximal direction which are indicated by the legend, and the structure or the direction indicated by the "B" is positioned on the right side under the condition that the two structures are sequentially or successively indicated by the "A", "B" and the like in the legend; for purposes of the present invention, the "0" scale is shown at the head end, with values greater than zero being on the right side of the "0" scale and larger scales being on the far right side. For the purposes of the present invention, in one aspect, the scale in the specification represents a specific scale marking on the drainage device, and in another aspect, the scale in the specification represents the actual distance of the location from the head end of the structure.

For the purposes of the present invention, reference in the specification to "distal" refers to a direction away from the operator of the drainage device and "proximal" refers to a direction toward the operator of the drainage device.

The filling and discharging accessory, the filling accessory and the filling accessory have the same meaning.

In the specification, the drainage object through holes or openings all refer to inlets for the drainage objects to enter a certain pipeline, and the specific expression forms of drainage tubes or stent tubes in the drainage device comprise stent tube inlets or drainage tube inlets.

In most embodiments of the present invention, for the requirement of external positioning of the clamping balloon and the drainage tube, substances containing barium sulfate, calcium carbonate, iron-containing particles and the like are added to all or part of structures such as the clamping balloon, the drainage tube, the communication tube, the sealing block, the stent tube and the like of the drainage device, so as to increase the absorption blocking effect on x-rays or electromagnetic signals, thereby realizing the display of the outline and the position of the device under x-rays or electromagnetic signals. This is consistent with most in vivo placement tubing positioning methods currently on the market.

In the invention, the thickness ratio represents the ratio of the thickness of the tube wall to the circumference of the outer surface of the tube wall in a section of tubular structure, and the thickness ratio of the clamping balloon wall represents the ratio of the thickness of the clamping balloon wall to the circumference of the outer edge of the maximum section of the clamping balloon filler in the expanded state.

The molding ratio reaction clamping saccule is under the restraint of the molding strip, and the clamping saccule is limited to expand outwards in the axial direction of the molding strip under the action of filling pressure of the filler; setting the distance between two connecting points of the shaping strip and the clamping balloon as X, and inputting filler into the clamping balloon in the connecting state of the shaping strip, wherein the length of the two connecting points is X1; under the condition that the shaping strip is cut off in the middle, filling materials are input into the clamping balloon under the same test pressure, and the length of two connecting points is X2; the shaping ratio of the shaped retention balloon is expressed as a percentage of the parameter X1 divided by X2. The test pressure is greater than 30cm of water.

For the purposes of the present invention, all references to rigidity of the rigid tube are to the least limited rigidity, in the sense that the rigid tube is meant to be radially incompressible or of limited compression to a degree that exceeds the local radial compression of the rigid tube by body tissue, such as the prostate, fascia, pericardial wall, gastrointestinal wall, rib space, etc. through which the drainage tube passes. The rigid structure in the drainage device is required to withstand the pressure of radial compression. In an embodiment of the invention, the rigid tube comprises a stent tube, the mobile communication tube comprises in particular a rigid portion passing through the sealing block, a breaking cutter tube portion, an outer and inner sleeve of a breaking sleeve, a drainage device delivery catheter, a push tube, etc. In some embodiments, a small amount of rigid structures are adopted at the edges of the sealing blocks, the drainage tube and the near-end interface of the fixed communicating tube, and the sealing blocks, the drainage tube and the near-end interface of the fixed communicating tube are mainly convenient to fix and hold.

For the purposes of the invention, the radial compressive strength of the rigid pipe is measured by adopting a pipeline cross-collapse experiment, and the specific method comprises the following steps of: two square flat plates are used as a bottom plate and a top plate, the flat plates are made of stainless steel or glass, the thickness is more than 3mm, the side length of each flat plate is 100mm, one flat plate is the bottom plate, the other flat plate is the top plate, the two flat plates are horizontally arranged, and the edges of the flat plates are parallel to each other; the circumference of the flexible pressure transmission hose is equal to that of the tested rigid tube, the circumference of the tube wall of the pressure transmission hose is enlarged after the liquid is input into the pressure transmission hose in the test process, the enlarged amplitude of the circumference of the pressure transmission hose is lower than 10% in the test process, the length of the pressure transmission hose is not limited, the pressure transmission hose is especially suitable for transparent people, and the stiffness experimental method and the stiffness optimal numerical value of the pressure transmission hose refer to the selection method and the optimal numerical value of the flexible material of the drainage tube in the invention. The length of the measured rigid pipe is equal to the circumference of the measured rigid pipe, the distance between the cut part of the measured rigid pipe and the head end of the measured rigid pipe in the stacking state is not less than 300mm, a circular supporting stock is inserted into the cut part in the process of cutting the rigid pipe of the measured section, the circumference of the stock is slightly smaller than the circumference of the inner side of the pipe wall of the measured pipe, the appearance of the rigid measured pipe is a circular pipe structure after the materials are obtained, folds, depressions or protrusions cannot appear on the surface of the rigid measured pipe, and the plane of the cut part of the measured pipe is perpendicular to the axis of the measured pipe. The tested pipeline is horizontally placed at the center position on the bottom plate, the central axis of the tested pipeline is parallel to one side of the bottom plate, the distances from the middle point of the central axis to the sides of the bottom plate are equal, and the bottom plate is parallel to the horizontal plane; the pressure transmission pipe and the center of the tested pipe are placed in a crossed mode, the pressure transmission pipe is perpendicular to the axis of the tested pipe, the flexible pressure transmission pipe extends to two sides in the direction perpendicular to the axis of the tested rigid pipe to form a gap between two testing plates, and two ends of the pressure transmission pipe extend upwards from two sides of the top plate respectively. The thickness ratio of the pressure transmission pipe preferably includes 0.001 to 0.03.

The top plate is positioned right above the bottom plate, each side of the top plate is parallel to each side of the bottom plate, the top plate is in a horizontal state and descends until the distance between the two plates reaches a starting test distance L1, L1=Dc+2Hs+2Hc, dc represents the original tube cavity diameter of the tested rigid tube, hs represents the tube wall thickness of the pressure transmission tube, and Hc represents the tube wall thickness of the tested rigid tube. The smaller the ratio of the wall thickness of the pressure hose to the circumference of the pressure hose, the greater the softness, and the lesser the influence on experimental data. Under the condition that the pressure transmission hose is soft enough in a complete ideal state, the pipe walls of the pressure transmission pipeline are attached together under the action of gravity, when the pressure transmission pipeline is horizontally placed, the turning radius of the edge of the pressure transmission pipeline is equal to the thickness Hs of the pressure transmission pipeline, and when the distance between the two test boards is L1, the measured rigid pipeline is only influenced by the weight of the rigid pipeline and the weight of the pressure transmission pipeline contacted with the rigid pipeline; in practical situations, a resistance is always generated when the pressure transmission pipeline is completely flattened, wherein the complete flattening refers to that the turning radius of two edges of the pressure transmission pipeline is equal to the thickness of the pipe wall when the pressure transmission pipeline is flattened; therefore, when the distance between the top plate and the bottom plate is L1, the tested pipeline is also subjected to the pressure caused by the deformation of the pressure transmission pipeline, the rigid pipeline cavity height W1 of the test point is smaller than Dc,

The test points represent the crossing points of the projections of the tested rigid tube axes between the top plate and the bottom plate and the pressure transmission tube axes on the horizontal plane; the height W of the tube cavity of the rigid tube of the test point represents the distance between the vertical line of the test point and two contact points of the inner wall of the rigid tube of the test point, and the reaction is the tube cavity height of the center point of the tube cavity of the rigid tube to be tested which is horizontally placed.

The closer the ratio of W1 to Dc is to 1, the less easy the tested rigid tube is to deform relative to the pressure transmission tube, the greater the relative radial strength of the tested test tube is, the better the relative softness of the pressure transmission tube is, the more accurate the experimental result is, and the ratio of W1 to Dc is required to be greater than 85%.

When the distance between the top plate and the bottom plate is L1, water is injected into the pressure transmission pipe, the intersection of the tested tube and the pressure transmission pipe is limited by the top plate and the bottom plate, the tested tube is pressed by hydrostatic pressure from the pressure transmission pipe and is further flattened and deformed, the cavity height of a test point in a pipeline of the tested tube is W2, when the value of W2 and W1 reaches 0.5, the relative height of a water column of the pressure transmission pipe is H50, and the value of H50 = the height from the bottom plate surface to the bottom of the concave surface of the water column of the pressure transmission pipe, namely-W2-2 Hc-Hs.

A graduated scale is vertically erected on the edge of a base plate, the 0 point of the graduated scale is positioned on the upper surface of the base plate, eyes of an observer and the lowest point of the center of the upper part inside the tested rigid pipeline keep the same horizontal position, and the measured rigid pipeline cavity height W is obtained by subtracting the thickness Hc of the wall of a measured pipeline from the graduation of the lowest point on the graduated scale.

The H50 value range of the rigid tube in the present invention includes 10cm water column to 5000cm water column, preferably 30cm water column to 800cm water column. H50 is a pressure, and other experimental methods capable of reflecting the pressure of the pressure transmission pipeline are effective, for example, the experiment using mercury instead of water requires pressure unit conversion, the experiment using air instead of water requires pressure measurement by using a barometer, and corresponding pressure unit conversion is performed.

The rigid tubular structure in the present invention comprises or is made of a polymeric compound selected from the group consisting of: polyolefins, polyesters, polyamides, polyurethanes, elastomers (such as thermoplastic elastomers), polyetherketones, organic polysulfides, copolymers of at least two of the polymers, and mixtures (blends) of at least two of the polymers.

The polyolefin may be selected from the group consisting of: polyethylene, low density polyethylene, high molecular weight polyethylene, ultra high molecular weight polyethylene, polypropylene, polytetrafluoroethylene, polyvinylidene fluoride, polyvinylidene chloride, polytetrafluoroethylene, polyhexafluoropropylene, copolymers of at least two of the polyolefins and mixtures (blends) of at least two of the polyolefins.

The polyester may be selected from the group consisting of: polyethylene terephthalate, polypropylene terephthalate, polybutylene terephthalate, copolymers of at least two of the polyesters, and mixtures (blends) of at least two of the polyesters.

The polyamide may be selected from the group consisting of: polyamide 6 (polymer of epsilon-caprolactam or omega-aminocaproic acid units), polyamide 66 (polymer of hexamethylenediamine units and adipic acid units), polyamide 69 (polymer of hexamethylenediamine units and azelaic acid units), polyamide 612 (polymer of hexamethylenediamine units and dodecanedioic acid units), polyamide 11 (polymer of 11-aminoundecanoic acid units), polyamide 12 (polymer of laurolactam acid units and omega-aminododecanoic acid units), polyamide 46 (polymer of tetramethylenediamine units and adipic acid units), polyamide 1213 (polymer of dodecanediamine units and dodecanedioic acid units), polyamide 6/12 (polymer of caprolactam units and laurolactam units), polyamide 66/610 (polymer of hexamethylenediamine units, adipic acid units and sebacic acid units), copolymers of at least two of the polyamides and mixtures (blends) of at least two of the polyamides.

The polyurethane may be selected from the group consisting of: aliphatic polycarbonate-type urethanes, silicone polycarbonate-type urethanes, polyether-type urethanes, silicone polyether-type urethanes, polyurethane-type ethers, copolymers of at least two of the polyurethanes and mixtures (blends) of at least two of the polyurethanes.

The thermoplastic elastomer may be selected from the group consisting of: thermoplastic copolyamides, thermoplastic polyester elastomers, thermoplastic copolyesters, olefin-based thermoplastic elastomers, styrene block copolymers, urethane-based thermoplastic elastomers, olefin-based crosslinked thermoplastic elastomers, copolymers of at least two of the elastomers, and mixtures (blends) of at least two of the elastomers.

The polyetherketone may be selected from the group consisting of: polyetherketoneketone, polyetheretherketone ketone, polyetherketoneketone ketone, copolymers of at least two of the polyetherketones, and mixtures (blends) of at least two of the polyetherketones.

The clamping saccule, the drainage tube and the fixed communicating tube in the drainage device are mainly made of flexible materials, and a part of the movable communicating tube in the individual embodiment is mainly used for improving the shape following property of the drainage device, reducing the traction extrusion damage of the drainage device to a drainage channel and reducing the resistance of the drainage device passing through the drainage channel.

The stiffness of the drainage tube flexible material of the present invention is preferably less than 15cm as measured by the cantilever test method defined in the stiffness A method of JIS L-1096 using a test piece of 2cm X10 cm. If the stiffness exceeds 15cm, there are cases where flexibility is insufficient and the drainage channel cannot conform to the shape and the shape.

On the basis of keeping the strength of the material, the smaller the thickness of the flexible material is, the more flexible the flexible material is, and the flexible material is used in drainage tubes and communicating tubes, wherein the thickness ratio of the flexible material to the communicating tubes preferably comprises: 0.001 to 0.12, preferably a value of 0.005 to 0.02; when used in a positioning balloon, the flexible material has a thickness ratio of preferably from 0.0001 to 0.01.

For the purpose of the invention, the flexible material is used on the clamping saccule, the drainage tube, the fixed communicating tube and the isolating piece, in particular to a part entering the drainage channel and the wall of the drainage tube which needs to turn over through the fold to provide space for the movement of the support tube.

For the purposes of the present invention, flexible materials include high molecular polymer films, as well as nonwoven fabrics, textiles, knits, and combinations of the above; the polymer film can be layered with non-woven fabrics, textiles and knits, or can be adhered or welded together after being respectively molded. In particular, the method comprises the steps of attaching the high molecular polymer to the textile fabric by dipping, coating and the like under certain physicochemical conditions, and in some embodiments, the flexible pipe wall is made of expanded polytetrafluoroethylene, in particular comprises a biaxially stretched polytetrafluoroethylene pipe.

The textile is preferably knitted fabric, and the fiber materials used in the knitted fabric comprise polymer fibers such as nylon, polytetrafluoroethylene, polyurethane, polyester, polyolefin, aramid and the like.

The polymer compound used for manufacturing the flexible pipe wall, the clamping balloon wall and the coating and dipping on the fabric comprises or is manufactured by the following polymer compounds, wherein the polymer compounds can be selected from the group consisting of the following components: polyolefins, polyesters, polyamides, polyurethanes, elastomers (such as thermoplastic elastomers), polyetherketones, organic polysulfides, copolymers of at least two of the polymers, and mixtures (blends) of at least two of the polymers.

The drainage tube is a tubular structure running in the drainage channel and the drainage gap, and the lumen inside the tubular structure is a pipeline through which drainage, medicine, flushing fluid and nutrient solution leave or reach the drainage cavity. The drainage tube includes: a drainage tube head and a drainage tube body.

The drainage tube plays three roles, namely, a guiding role, comprising guiding drainage matters, liquid input into a drainage gap, a bracket tube, a movable communicating tube, a breaking cutter, a breaking sleeve and a guiding guide wire; secondly, a part of the drainage tube is connected with the clamping saccule to ensure that the relative positions of the drainage tube, the drainage gap and the drainage channel are kept unchanged; and thirdly, the isolation function is realized, a part of the tube wall of the drainage tube is used as the interval between the drainage tube and the clamping saccule as well as between the drainage tube and the communicating tube, so that the tightness of the filler in the clamping saccule and the inside of the fixed communicating tube is maintained.

The length of the drainage tube guides the length from the head end to the tail end of the drainage tube, and the length of the drainage tube at least comprises the length of a drainage channel, the external part and the head length of a drainage cavity, and the total length of the drainage tube is selected from 50mm to 7000mm. The drain tube circumference range includes 5mm to 80mm.

For the purpose of the invention, in some embodiments, the interface of the tail end of the drainage tube body in the drainage device comprises a rigid material, the wall of the drainage tube comprises a flexible material, and the length of the flexible tube wall accounts for 5% -99% of the total length of the drainage tube.

The drain head and body forming means is taken from the group consisting of: extrusion, blow molding, compression molding, suction casting, coating, dipping, vacuum deposition, sewing, bonding, welding (including vibration welding, hot melt welding), and combinations of at least two of the foregoing. The processing process also comprises the following steps: under the condition of layering processing of the drainage tube, the head part and the body part comprise different processing modes on the same layer, such as physical methods of carrying out secondary heating and pressurizing on different parts; and the head and the body are locally layered and thickened.

Chopped fibers of high polymer fiber materials can be added into the manufacturing materials of the head and the body of the drainage tube, and long fiber materials can be arranged or woven on the drainage tube in the processing process of the drainage tube, and the arrangement mode of the fiber materials is selected from the group consisting of the following modes: a plurality of wales of single fibers, a plurality of wales of pre-woven fiber bundles, a plurality of fiber monofilaments in a helical arrangement, a plurality of pre-woven fiber bundles in a helical arrangement, a mesh woven from a plurality of monofilaments, a mesh woven from a plurality of pre-woven fiber bundles, and combinations of at least the foregoing.

Preferably, in the case of reinforcement treatment with a fibrous material, the number of longitudinal fibers is greater than the number of transverse fibers in terms of the direction of arrangement of the reinforcing fibers of the drainage tube wall; in particular, the inner layer of the tube wall of the drainage tube is purely reinforced by longitudinal fibers. The longitudinal fiber of the drainage tube mainly bears the longitudinal friction force of the head end of the support tube on the inner side wall of the drainage tube when the support tube in the drainage tube passes through. While the longitudinally aligned fibrous material affects less the softness of the draft tube in the radial dimension.

The preparation materials of the body and the head of the drainage tube can be reinforced by other micro fiber materials, and the micro fiber materials comprise the following components: carbon black, carbon nano tube and polymer fiber material chopped fiber, and the reinforcing strength of the method is isotropic.

The flexible material also comprises a biaxially oriented tubular material and a spherical material, and particularly comprises biaxially oriented polytetrafluoroethylene, polyethylene, nylon, polyurethane, thermoplastic elastomer and other film materials.

The head end, the head section and the head part refer to one end, one section and one part of the drainage device which firstly enters the drainage channel and is far away from an operator when being placed into the drainage channel respectively. The other end corresponding to the head end is a tail end, and one section or a part of the tail end is a tail section or a tail part. The body refers to the portion of the drain tube other than the head. The far direction is the direction far away from the operator, namely the direction of the head end of the drainage device; the approach refers to the direction of approaching the operator, i.e. the direction of the tail end of the drainage device. The drainage tube drainage state refers to a state in which the stent tube maintains support to a narrow portion of the drainage channel and the stent tube inlet and the drainage tube inlet are in communication with the drainage substance, and it is specifically noted that such communication is a state in which the drainage substance can actually circulate, including but not limited to, complete anastomosis of the stent tube inlet and the drainage tube inlet. The drainage tube non-drainage state refers to a state in which the stent tube is withdrawn to the proximal side or the distal side of the drainage channel stenosis.

The main function of the head of the drainage tube is four, namely, the head of the drainage tube is connected with a clamping saccule, and the whole drainage device is fixed; secondly, the drainage is collected through holes arranged on the wall of the head pipe and communicated with the holes on the bracket pipe, so that the drainage is transferred; thirdly, when the drainage device is placed, the head can be attached to the bracket tube to drive the whole drainage device to enter the corresponding position; fourth, in some embodiments, the drainage tube head is provided with a guide hole, and the drainage device is pushed forward along a guide wire passing through the guide hole.

The head of the drainage tube guides a section of drainage tube between the head end of the drainage tube and the proximal edge of an inlet on one drainage tube at the nearest center, and can also be a part of drainage tube between the nearest center point of the connection part of the drainage tube clamping balloon on the drainage tube and the head end of the drainage tube, when the length values of the head of the drainage tube calibrated by the two methods are inconsistent, the head of the drainage tube is calibrated by one method with larger length value of the head of the drainage tube calibrated by the two calibration methods; according to the difference of the relative positions of the clamping balloon and the axial position of the drainage tube, the head of the drainage tube comprises three parts including a balloon section, a balloon front section and a balloon rear section, and the head of the drainage tube also comprises a hole section.

The hole section is a section of drainage tube or support tube with a plurality of drainage material inlets distributed continuously, and the hole of the hole section does not comprise an outlet at the tail end of the drainage tube; the bag section is a section of drainage tube head structure for guiding the flow tube and the clamping saccule to be mutually overlapped; in some embodiments, the drainage tube passes through the clamping balloon, the drainage tube structure positioned at the front side of the clamping balloon is a balloon front section, and the drainage tube head balloon front section is usually provided with a drainage object inlet; the rear section of the bag refers to a section of the flow tube head positioned at the near side of the clamping balloon. The hole sections of the drainage tube at the front section and the rear section of the bag are set as two hole sections. In some embodiments, the drainage tube head side wall is connected with the clamping balloon wall, the connection part distal drainage tube is a balloon front section, the connection part proximal drainage tube head is a balloon rear section, the connection part drainage tube section is a balloon section, and the hole sections can be distributed in the balloon front section, the balloon rear section and the balloon section.

The proportion of the length of the head of the drainage tube accounting for the whole length of the drainage tube comprises 10 to 90 percent.

The drainage tube inlet aims at four, namely, the inlet of the drainage material is provided and is a necessary condition for drainage, and on the other hand, the distribution range of the drainage material inlet on the drainage tube is increased in some embodiments, so that the head part extends into the drainage channel, components between the drainage tube wall and the drainage channel are mutually exchanged with the drainage material in the drainage tube, a self-cleaning effect is provided, and the cavity components between the drainage tube wall and the drainage channel are updated faster compared with the traditional drainage tube; an additional object is that the holes on the wall of the drainage tube can increase the softness of the drainage tube; in some embodiments the front end of the head is a blind end with a pilot hole in the center that allows the guide wire to pass through so that the drainage device climbs over the guide wire and is pushed along the guide wire into the drainage gap.

The preparation process of the drainage tube inlet comprises directly knitting or braiding a pore-forming structure by using a fiber material, and can also be formed on a processed and formed drainage tube by adopting methods such as metal cutter cutting, laser cutting and the like, and can also be formed by compression molding.

The surface porosity of the pipeline represents the density of a section of drainage tube expanded by a stent tube or a stent tube hole in a natural state, the sum of the inlet areas of the drainage material of the section of the pipeline is Sk, the total surface area of the section of the hole is Sz, the ratio of Sk to Sz is the surface porosity of the pipeline, the surface porosity of the pipeline of the section of the hole comprises 10 to 99 percent under the condition that the axial distribution density of the drainage tube is approximately consistent, and the surface porosity of the pipeline of the section of the hole can also change in the axial direction of the drainage tube. The support tube does not receive drainage channel's distortion after getting into drainage cavity back its walking, and support tube head end reduces the friction shear force to drainage tube pipe wall, and the mechanical strength requirement to the drainage tube section pipe wall that sets up at drainage cavity is reduced relatively, and the increase of this section drainage tube hole increases and drainage hole perimeter more helps realizing faster drainage speed.

In the drainage state, as the drainage tube inlet and the support tube inlet do not have a corresponding position relationship, a plurality of holes are formed in the tube walls of the drainage tube head and the support tube front section as much as possible, when the support tube hole section is overlapped with the drainage tube head Kong Duanxiang, as the surface porosities of the two tube surfaces are increased, a part of the holes in the two tube walls are communicated with each other, and drainage can pass through the communicated holes to realize movement; in another aspect, the drainage material can enter the gap between the drainage tube and the stent tube and then enter the stent tube to flow out of the drainage channel. The drainage speed is commonly influenced by drainage resistance in the drainage tube and the stent tube.

The porosity of the head of the drainage tube can vary in the axial direction of the head of the drainage tube, for example, a hole section is needed to provide a drainage outflow channel, holes on the hole section have the effect of improving the local softness of the drainage tube, and the hole section has the effect of exchanging a small amount of drainage inside and outside a tube cavity to improve the local cleanliness. Properly reducing the porosity of the tube surface of the inner bore section of the drainage channel can increase its mechanical strength without increasing the thickness of the drainage tube. Methods of varying porosity include varying the size of the local pores and the number of pores.

In the expansion state of the support tube matched with the flexible drainage tube head hole section, the shape of the inlet edge of the head of the drainage tube comprises a circle, an ellipse, a square, a rectangle, a triangle, a pentagon, a hexagon, an irregular polygon and a gap; because most of the flexible sections of the head of the drainage tube need to be repeatedly expanded by the support tube, the long axis of the inlet of the drainage tube is parallel to the axial direction of the drainage tube, which is beneficial to reducing the friction force of the support tube passing through the drainage tube hole sections.

The number of the drainage tube or the drainage object intersecting holes of the stent tube comprises 1 to 1000, preferably 2 to 100.

In some embodiments, the flexible drain head tube segment is implemented by a woven mesh, and the drain head aperture Duan Da is partially weighted by a fibrous material, which accounts for 1% -99% of the drain head aperture Duan Chong by weight.

The fibers used in the mesh head include polyester fibers, polyamide fibers, polyolefin fibers, aramid fibers, polyurethane fibers, vegetable fibers, animal fibers, and combinations of at least two of the foregoing.

The mesh structure of the head hole section comprises longitudinal fibers which are parallel to the longitudinal axis of the drainage tube and are more than transverse fibers which are perpendicular to the longitudinal axis of the drainage tube.

In some embodiments, the drain head comprises a rigid tubular structure, including both cases, 1) the drain itself is a rigid tubular structure; 2) A section of rigid support tube is secured or placed on the drainage tube head.

In some embodiments, the head hole section of the drainage tube maintains a rigid circular tube state, and the rigidity state is particularly suitable for the conditions that a drainage channel is narrow and sensitive, and discomfort is easy to cause in the drainage process, for example, a urine tube is required to be reserved for a male prostatic hyperplasia patient because urine is reserved, the urine can be emptied in a short time because the viscosity of the urine is small, the head hole section of the rigid drainage tube provides enough urine inlets for the head hole section of the drainage tube, when a part of a support tube enters the head of the rigid drainage tube, the urine inlets can be provided for the inlets of the whole head of the drainage tube, so that urine can be discharged as soon as possible, and the support tube of the drainage tube can quickly exit the bladder area later. In theory, the head of the flexible drainage tube can meet the requirement of drainage, the support tube needs to enter the head of the flexible drainage tube more, the head of the flexible drainage tube can be communicated with the drainage material inlet of the head of the flexible drainage tube more, the drainage speed is faster and faster, the support tube can exit the bladder area only after taking more strokes after the urine drainage, and the support tube has more stimulation time and strength to the prostate. The rigid structure of the head of the drainage tube is kept, so that the moving range of the drainage tube support tube is smaller, the travel range of the drainage tube support tube during drainage is reduced to a certain extent, the maintenance time of the support tube at the prostatic urethra is shortened, and the prevention of infection after the tube is placed is facilitated; on the other hand, the rapid urine drainage is helpful for the establishment of urination sensation and provides assistance for the recovery of bladder function.

In some embodiments, the rigid drain tube head has a resiliently curved shape, and movement of the rigid drain tube head in the drain channel may be achieved by pulling on the drain tube head, thereby achieving expansion of the drain channel.

In other embodiments, after the chest is placed into the drainage tube with the rigid drainage tube head, the stent tube does not need more strokes into the chest, reducing the chance of retrograde infection. In the design concept, the head of the rigid drainage tube is equivalent to that a section of the support tube is fixed at the head of the drainage tube, or is equivalent to that a section of the support tube replaces the head of the drainage tube, so that the hole section of the head of the rigid drainage tube is arranged with reference to the support tube of the drainage device with respect to the tube diameter, the tube wall thickness, the tube wall material, the tube wall strength and the like. The hole parameters arranged on the head hole section of the rigid drainage tube comprise the size, the number, the shape and the distribution of the reference flexible drainage tube head hole section relative to the hole.

In some embodiments, the front end of the head of the drainage tube is expanded into a sphere, the sphere head is matched with the size of the clamping balloon, the clamping balloon is wrapped from the outside of the clamping balloon, further, a hole is formed in the sphere head, dead space between the sphere head and the clamping balloon is reduced, and the circulation flow of local drainage materials is facilitated. When the clamping balloon is mostly wrapped by the spherical head of the drainage tube, after the clamping balloon is filled, the volume of the clamping balloon is increased, the clamping balloon cannot be separated from the hole of the spherical head of the drainage tube wrapped by the clamping balloon, and the clamping balloon is fixed in the spherical head of the drainage tube; the clamping balloon can also be connected with the spherical head part in a certain way, and the connection can be exemplified by a manufacturing way comprising sticking, welding, material extension and the like.

In the invention, two conditions exist that the front end of the drainage tube stretches out of the clamping balloon: a, a drainage tube passes through the clamping saccule from the inside of the clamping saccule; b the drainage tube extends from one side of the clamping balloon beyond the clamping balloon to the far side of the clamping balloon.

The blind end of the head of the drainage tube refers to the closed round end of the tube wall at the foremost end of the flow tube. The axial distance from the position where the diameter of the head pipe wall of the drainage pipe begins to be reduced to the furthest point of the head end of the drainage pipe is the length of the blind end of the drainage pipe, and the ratio of the length of the blind end to the perimeter of the drainage pipe is 0.1 to 10.

In some embodiments, the head of the drainage tube passes through the clamping balloon, a guide hole is arranged at the center of the blind end of the head of the drainage tube, the guide hole is a round hole, the circumference of the round hole comprises 3mm to 6mm, the guide hole is used for enabling a guide wire to penetrate into the drainage tube from the guide hole and penetrate out of the tail end of the drainage tube, and the drainage tube is pushed to a specified position under the guidance of the guide wire. The guide wire can be derived from accessories included in the invention, and can also be derived from other medical devices such as guide wires used for deep vein catheterization and guide wires of transnasal biliary tract drainage tubes; the drainage tube is pushed forward along the guide wire, the pushing device can use a bracket tube, an externally matched rigid tubular structure, such as a section of sputum suction tube, a section of traditional catheter, a venous catheter and the like, and a pushing tube.

The material composition and manufacturing method of the pushing tube refers to the stent tube, and the pushing tube is designed to keep openings at the head end and the tail end so as to ensure the passage of the guide wire. The circumference of the push tube comprises 8mm to 20mm and the thickness ratio thereof comprises 0.01 to 0.1.

At least one section of the drainage tube wall is a flexible pipeline, which is the most main characteristic of the invention, different from other traditional drainage tubes, and in most embodiments of the invention, the drainage tube wall is made of flexible materials, and the main components of the drainage tube wall are high molecular polymers and fiber materials compounded in the polymers. Since the tube wall is not required to support the stability of the lumen, its hardness (shore a): 10 degrees to 40 degrees.

The tensile strength of the pipe wall material is derived from the pipe wall polymer and the fiber material compounded in the polymer, and the fiber reinforcement material accounts for 0-90% of the weight wt%.

The drainage tube body is a tubular structure for isolating and guiding the drainage material from the outside to a designated position, the drainage tube body comprises an internal section and an external section, in different embodiments, the internal and external parts have no obvious limit, and the non-flexible material of the drainage tube body comprises a clamping structure, an extension structure and the like between the interface and the support tube.

The body flexible material keeps the tightness of the drainage object, the drainage object is restrained from flowing in the drainage tube, the body flexible material is mainly used for shortening the local length of the drainage tube through deformation such as the crease and the turnover of the wall of the drainage tube, the local length of the drainage tube is prolonged through leveling the crease and the turnover part of the wall of the drainage tube, the change of the local axial length of the drainage tube provides possibility for the movement of a support tube positioned on the inner side of the body of the drainage tube, and the flexible body of the drainage tube has good shape following property.

The drainage tube body refers to a part near the head of the drainage tube, the parts of the drainage tube except the head of the drainage tube are called as drainage tube bodies in the invention, the proximal end of the drainage tube body is also called as a tail end for convenience of description, a section of the drainage tube body including the tail end is called as a tail section, the length of the tail section is less than half of the length of the drainage tube body, and after the drainage tube is placed at a corresponding position, the drainage tube is divided into an internal section and an external section by a drainage channel body surface opening. The external length of the drainage tube is 100mm to 1500mm, and is mainly used for the convenience of daily use and operation or the requirement that the stent tube completely exits the narrow part of the drainage channel.

The tail end of the drainage tube body is an open port, and the main functions of the drainage tube are as follows: a provides certain strength and rigidity for convenient holding, and provides structural support for plugging or accommodating other pipelines; b, an inlet and an outlet of the drainage object and the input object; and c, inlet and outlet of the bracket tube, the guide wire and the pushing tube. Preferably, the wall of the drainage tube in the range of 5-50mm near the tail end of the drainage tube body is of a rigid structure, the hardness of the wall of the drainage tube is higher than that of the adjacent flexible tube, and the wall of the drainage tube has higher hardness, so that the drainage tube is beneficial to being in butt joint and fit with an external pipeline; in particular, the tail end of the drainage tube body is attached with a bayonet, which comprises: male luer lock connection port, female luer lock connection port, internal port with screw connection port, external port with screw connection port.

In other embodiments, the drain outlet is located on one side of the tail section of the drain tube and forms a tubular bifurcation having an axial direction that is not coincident with the axial direction of the main drain tube, typically for delivering a drain; the tail end of the main drainage tube can be provided with a switch, such as a clip and a plug. The guiding bracket tube can be replaced by opening the switch at the tail end of the main drainage tube. In some embodiments, the drainage device needs larger drainage quantity in the early stage, a support tube with a thicker tube diameter is needed to be communicated with the head of the drainage tube, or drainage materials are gradually clear along with the reduction of the drainage quantity in the later stage, or fresh granulation tissue hyperplasia and partial edema of a drainage cavity and a drainage channel (such as sinus tract) are reduced in the healing process, the sinus tract is contracted, the support tube used in the early stage is unsuitable, the necessity is needed for replacing a support tube with a thinner one, the closed structure at the tail end of the body part of the drainage tube is opened, the original support tube is pulled out, and a new support tube is more convenient to put in; in addition, the stent tube is replaced in the early stage, a stent tube with a relatively smaller circumference is used for completing the placement process of the drainage device, because the stent tube has a small circumference, the stimulation to a drainage channel is small, the placement is easy, and the comfort level of the placement process is high; the subsequent replacement of one large caliber rack pipe is favorable to drainage of granular tissue block, food, stone, foreign matter, etc. and the rack pipe with greater perimeter is easy to be set in due to the protection of the drainage pipe.

The ratio of the force (unit: N) born by the two ends of the drainage tube when the drainage tube is pulled and broken to the circumference (unit: mm) when the drainage tube is not pulled is greater than 0.2N/mm, preferably greater than 1N/mm, more preferably greater than 10N/mm. The clamping stress range of the two pulled ends at least comprises a drainage tube with the axial length of 10 mm.

The first function of the support tube is to realize the expansion of the wall of the flexible drainage tube at the narrow part by moving in the drainage tube, so as to keep the smoothness of the drainage channel; when the stent tube is moved out of the narrow part of the drainage channel, the flexible tube wall of the drainage tube collapses, and the drainage channel is closed or enters a slow drainage process; the second function is that the bracket tube props against the head end of the drainage tube, and the drainage tube and the clamping saccule are pushed to the drainage gap; the third function is that the stent tube is forced to push towards the clamping balloon along the inner side or the outer side of the drainage tube, the clamping balloon tension is increased, the part with the largest or the weakest stress in the clamping balloon structure is broken, and the clamping balloon filler is removed from the clamping balloon; the fourth function is to guide the blocking saccule to break the cutter to a proper position; a fifth function, wherein the bracket tube is connected with a movable communicating tube in the drainage device in series, and the auxiliary clamping saccule is used for placing and inputting clamping saccule filling materials; the sixth function, along with the different depth of the stent tube penetrating into the drainage gap, can drain or convey fluid to different parts of the drainage channel or the drainage gap; seventh function, under special circumstances, a section of the drainage tube and at least a part of the bracket tube are combined into one, playing a role in common; eighth effect, the whole support pipe that is located drainage cavity inside under special circumstances, this support pipe and drainage tube one section combine together, move in and out drainage channel stenosis position along with the drainage tube, realize drainage process.

The support tube is movably arranged in the drainage device, the support tube is arranged into a hollow rigid tube, a drainage material inlet is arranged at the head section of the pipeline, and a drainage material outlet is arranged at the tail section and/or the tail end of the support tube; preferably, besides the drainage outlet arranged at the tail end of the support tube, a plurality of drainage outlets are arranged at the tail section of the support tube, and a plurality of drainage inlets are arranged at the tube head section of the support tube, so that the speed of the drainage entering the support tube is improved; correspondingly, a plurality of drainage outlet ports are additionally arranged at the tail section of the drainage tube support tube, so that the speed of the drainage leaving the support tube is increased. In particular, in some cases, the tail end of the support tube is fixed with the tail end of the drainage tube, the tail end of the support tube and the tail end of the drainage tube share one outlet, and a plurality of drainage outlets at the tail section of the support tube avoid that a cavity gap between the tail section of the drainage tube and the tail section of the support tube becomes a dead space, and the dead space refers to a cavity gap with only one opening communicated with the outside. Under special conditions, the stent tube inlet only comprises a front end opening, or the front section opening of the stent tube is concentrated at one section, so that under the conditions, the drainage point of the stent tube and the arrival point of the conveying substance are concentrated at one position, the stent tube inlet has special significance for the digestive tract drainage device, and can drain the contents of different parts of the digestive tract so as to achieve the purposes of treatment and diagnosis; fluid is input to different parts of the alimentary canal to achieve different treatment purposes.

In addition, desirably, the portion has a lateral flexibility (stiffness) of at least 1200 degrees deflection/in-lbs (measured at 20 to 30 degrees deflection, with 0.005lb load, over a 0.25 "span), preferably greater than 3600 degrees deflection/in-lbs, as would be measured by, for example, a Tinius-olsen (tm) stiffness tester.

The organic polymer material of the stent tube has the following preferable hardness values: 10 degrees to 50 degrees. In some embodiments, the head end of the support tube is a blind end, a guide hole is usually arranged in the center of the blind end, the perimeter length of the guide hole preferably comprises 3mm to 6mm, a guide wire passes through the guide hole and the guide hole of the blind end of the drainage tube, the drainage device is guided to move towards the drainage gap, and the ratio of the minimum radius of the extrados circumcircle of the blind end to the radius of the support tube is 0.1 to 10; preferably 0.5 to 2;

the processing method of the blind end comprises the following steps: and plugging a section of high polymer material block on the pipeline port of the open support pipe, polishing, and integrally forming the blind end and the support pipe.

In other embodiments, the head end of the stent tube is an opening of the stent tube after being cross-sectioned, and the tube wall at the opening is rounded, and the method comprises turning, polishing, heating and shaping, coating high polymer materials and the like.

In the process of manufacturing the stent tube, fibrous materials are arranged or woven on the stent tube, and the arrangement modes of the fibrous materials comprise: a plurality of fiber monofilaments in a helical arrangement, a plurality of pre-programmed fiber bundles in a helical arrangement, a net woven from a plurality of monofilaments, a net woven from a plurality of pre-programmed fiber bundles, and combinations of at least the two. Preferably, the arrangement direction of the reinforcing fibers of the stent tube is as follows: the wall reinforcing fibers of the support tube are reinforced in a spiral arrangement mode, and the number of spiral arrangement turns of the spiral arrangement fiber material in the axial direction of 1cm length is preferably 1-10.

The reinforcement material for the stent tube further comprises wires having a diameter smaller than the thickness of the wall of the stent tube, preferably arranged in a spiral fashion around the wall. Alloy combinations that may be cited In the wire include Au-Cd, ag-Cd, cu-Zn-Al, cu-Zn-Sn, cu-Zn-Si, cu-Sn, cu-Zn-Ga, in-Ti, au-Cu-Zn, niAl, fe-Pt, ti-Ni-Pd, ti-Nb, U-Nb and Fe-Mn-Si, and the wt% content of one of the metals In the wire is preferably 1% to 98%. The helically arranged wires are helically arranged in 1 to 10 turns over an axial length of 1 cm. Additionally, the wire comprises stainless steel wire, silver wire, copper wire.

The determining factor of the circumference of the outer circumference of the cross section of the stent tube for the purpose of the invention is the inner diameter of the drainage tube which is matched with the circumference of the outer circumference of the cross section of the stent tube, and the difference between the length of the circumference of the outer surface of the drainage stent tube and the length of the circumference of the inner side surface of the drainage tube is 1mm to 20mm for the purpose of reducing the moving resistance of the stent tube in the drainage tube.

The circumference of the stent tube in the present invention varies depending on the embodiment, and accordingly, the thickness of the stent tube varies, and for the purpose of the present invention, the thickness ratio of the stent tube is 0.002 to 0.12, preferably, the value is 0.005 to 0.02.

The forming mode of the bracket tube comprises the following steps: extrusion molding, blow molding and compression molding, and can also be made by secondary processing from the catheters which are used in the medical science and are traditionally molded, such as vein catheterization, gastric tube, catheter, sputum suction tube, ureter double j tube, nasal bile duct, biliary tract T-shaped tube and the like.

In some embodiments, the stent tube inlets are continuously distributed in a section of the stent tube near the head end, the section is a stent tube hole section, the stent tube hole section accounts for 1% to 70% of the length of the stent tube tubular structure, the stent tube hole section comprises a tube section between the furthest stent tube side hole and the nearest stent tube side hole, the stent tube hole section is moved into the drainage tube passing through a certain section of drainage gap or drainage channel, so that the local drainage or perfusion can be performed, and the drainage tube wall is preferably configured to comprise the drainage tube inlet. For example, the head end of the drainage tube is already placed in a drainage device below the duodenal dropsy ligament, and the stent tube can drain or perfuse the stomach, the duodenum, the jejunum and the like, so that the accuracy of medical intervention is improved. In further embodiments, the stent tube includes only two openings at the cephalad and caudal ends, and point-to-point drainage or perfusion procedures may be achieved. In further embodiments, the stent tube is provided with stent tube ports extending over the entire axial length of the stent tube.

The stent tube inlet holes are continuously equidistantly distributed over a length of the stent tube hole section, and the minimum distance between two adjacent stent tube inlet holes comprises 0.1mm to 20mm, preferably 1mm to 15mm.

The shape of the stent tube inlet hole includes: circular, elliptical, rectangular, diamond-shaped, and strip-shaped slits. The vertex of the inlet hole of the rectangular and rhombic support tube is provided with a circle-smearing shape; preferably, the long axis of the stent tube inlet is perpendicular or nearly perpendicular to the axial direction of the drainage tube. The ratio of the stent tube inlet surface edge perimeter length to the stent tube perimeter length comprises 0.1 to 10.

Preferably, the stent tube inlet shape of the first half of the stent tube comprises one or several of the following forms for the purpose of preserving as much radial strength as possible: a C-shaped slit, a spiral slit, a straight slit, the width of which comprises 0.1mm to 3mm, the ratio of the circumferential length of the slit to the circumferential length of the stent tube comprising 0.2 to 100, in embodiments in which the slit is used as an inlet for the stent tube, the wall material between the slit and the slit is mostly also a spiral-shaped, in particular a spiral-shaped wire, which is advantageous for the lateral displacement of the stent tube. The number of spirals Zhou Juanshu of helically distributed slits comprises 1 to 10 per 10mm axial length of the stent tube. The C-shape of the C-shaped slit represents a portion of a ring shape that includes the cross-sectional shape of the non-porous section of the stent tube.

The distribution of the stent tube inlets on the stent tube can reduce the strength of the stent tube on the original basis, and the stent tube is easier to flatten under the condition that the long axis direction of the stent tube inlets is parallel to the axial direction of the stent tube; the stent tube is more easily bent in the case that the long axis direction of the stent tube inlet is perpendicular or nearly perpendicular to the stent tube axial direction. Preferably, in order to improve the comprehensive throughput and drainage capability of the stent, in some embodiments, a distribution structure is adopted in a head section at least comprising 20% of the length of the stent, wherein the long axis of the stent inlet is perpendicular or nearly perpendicular to the axial direction of the stent, and the included angle between the plane of the stent inlet and the axial direction of the stent comprises 65 DEG to 90 DEG; the tail section at least comprising 30% of the length of the stent tube comprises a distribution structure in which the plane of the outlet of the stent tube is parallel or nearly parallel to the axial direction of the stent tube, and the included angle between the plane of the inlet of the stent tube and the axial direction of the stent tube comprises 0-15 degrees, so that the structure is more beneficial to the retention of the axial strength of the stent tube and the axial pushing of the stent tube along the drainage channel.

In most embodiments, the stent tube should be fixed inside the drainage tube to avoid the stent tube from slipping out of the drainage tube under the action of gravity, one way of fixing includes that the tail end of the stent tube is fixedly connected with the tail end of the drainage tube, and the fixing method includes bonding, thermal shrinkage, welding and embedding of elastic snap ring concave protrusions; the other fixing comprises a section of drainage tube wall circumference reduction, so that the support tube is blocked from sliding out, and the drainage tube wall circumference reduction mode comprises thermal shrinkage, sleeving and pasting of an elastic tube with smaller circumference and the like. Another method is to provide a snap ring at the tail end of the drainage tube, which has the advantage of simple structure, and in some embodiments the snap ring or the reduced wall of the drainage tube has elastic and expandable properties, and the stent tube can be moved out of the snap ring or the constriction of the wall of the drainage tube when more force is applied. Preferably, the tail end clamping ring of the drainage tube is a detachable clamping ring, and comprises a detachable clamping ring fixed by a screw structure.

In some embodiments, the bracket tube is used in series with the mobile communication tube, the connection mode comprises that the mobile communication tube is inserted into the front end of the bracket tube and extends into the front section tube cavity of the bracket tube, and the bracket tube and the mobile communication tube are rotationally fixed together by friction force or screws; or after the tail end of the movable communicating pipe is expanded, the bracket pipe is inserted into the tail end of the expanded movable communicating pipe, and the bracket pipe and the tail end of the movable communicating pipe are rotationally fixed together by friction force or screws; the two are connected in series to ensure that the lumen of the two are communicated with each other, and the bracket tube and the movable communicating tube which are connected together commonly have two openings at the front end and the rear end, so that the two are connected into a whole to have the filler transmission capability; the connection mode between the two can seal the inlet of the support pipe on the side wall of the pipe section of the support pipe and the movable communicating pipe. The other support tube and the movable communicating tube are connected in series in an integrated mode, one support tube can be selected in the embodiment, and after the support tube and the communicating tube are pulled out, the other support tube is placed in the embodiment when needed.

In order to avoid damage to tissue around a drainage channel or a drainage gap caused by the fact that the head end of the stent tube penetrates out of a hole in the drainage tube, at least one transverse section circumference of the head end of the movable stent tube is larger than the circumference of an inlet of the drainage tube, the wall of the stent tube where the transverse section is located is a stent tube safety point, in special cases, the circumference of the transverse section of the stent tube near the safety point can be smaller than the circumference of the hole in the drainage tube, holes with larger circumferences can be formed in the wall of the stent tube near the safety point, the holes with larger circumferences of the stent tube are used for providing an outlet of a breaking cutter with an arc-shaped head structure on the stent tube, the holes with larger circumferences enable the wall of the stent tube to be sunken relatively close to the wall, and when the stent tube drives the clamping balloon to advance towards the drainage gap, the sunken position balloon and a structure (such as a sealing block) for attaching the clamping balloon can be contained as much as possible, and the design enables the drainage device to be smooth when being placed into the drainage gap.

The pipe body performance parameters of the broken cutter pipe part, the inner and outer sleeves of the broken sleeve, the pushing pipe, the expansion pipe and the movable communicating pipe refer to the performance parameters of the bracket pipe, and under the condition that the description is not specific, the performance parameters of the broken cutter pipe part, the inner and outer sleeves of the broken sleeve, the pushing pipe, the expansion pipe and the movable communicating pipe refer to radial strength and tensile strength. The ratio of the radial strength, the tensile strength and the radial strength of the stent tube to the tensile strength of the broken cutter tube part, the inner and outer sleeves of the broken sleeve, the push tube, the expansion tube and the movable communicating tube is 30-200%.

The clamping balloon body is of a flexible thin-wall saccular structure, the structure is similar to the clamping balloon of the catheter and the sealing balloon on the tracheal intubation in the current market, and fluid substances are needed to be used for filling the clamping balloon body, and are called clamping balloon filling materials. The filled saccule wall expands, and the saccule body and the structure connected with the saccule body are fixed in the drainage gap to realize the clamping function in the invention. The tightness of the balloon body against its filling determines its duration of the retention function. In some embodiments, the elasticity of the clamping balloon by the self material enables the inside of the clamping balloon to keep higher pressure than the outside of the clamping balloon, after the sealing performance of the clamping balloon is broken, the filling material in the clamping balloon flows out of the clamping balloon under the driving of the pressure in the clamping balloon, the wall area of the clamping balloon is reduced to be less than 60% of the expanded state, and more preferably the reduction amplitude is less than 10%, and the clamping balloon is called an elastic clamping balloon; the other type of clamping balloon is an inelastic clamping balloon, the wall of the inelastic clamping balloon is made of flexible inelastic materials, after the sealing performance of the wall of the clamping balloon is damaged, the sealing performance of the wall of the clamping balloon cannot maintain continuous pressure inside the balloon, the filler is removed from the outside of the balloon body, the filler is required to be extruded or sucked out of the balloon body by means of external force, the clamping balloon is continuously pulled to form pressure inside the balloon, the clamping balloon filler is driven to move out of the clamping balloon, and after the inelastic clamping balloon filler is released, the wall area of the clamping balloon is larger than or equal to 80% of the wall area of the clamping balloon in an expanded state.

The elastic clamping balloon is made of elastic materials, and the wall of the elastic clamping balloon comprises the following high molecular compounds or is made of the following compounds, wherein the compounds can be selected from the group consisting of the following compounds: polyurethane, elastomers (such as thermoplastic elastomers), organic polysulfides, copolymers of at least two of the polymers, and mixtures (blends) of at least two of the polymers, the elastomeric stopper balloon wall including, inter alia, a latex component.

The non-elastic clamping balloon is made of the flexible material according to the invention, and because the clamping balloon does not need to be provided with a hole with an opening between the clamping balloon and the drainage tube, the probability that the wall of the clamping balloon is rubbed by the stent tube is low, and the requirements on the directionality of the reinforced material and the drainage tube are lower.

The forming mode of the balloon comprises the following steps: extrusion molding, blow molding, compression molding, coating molding, and subsequent processing methods including multilayer lamination, dipping, winding, bonding, welding, fiber material reinforcement, and combinations of at least the foregoing. Specifically, the clamping balloon, the drainage tube and the communicating pipe are integrally processed, or at least one layer is processed by the same method, and particularly, the clamping balloon, the drainage tube and the communicating pipe are integrally formed by adopting blow molding and stretching.

After the clamping balloon is placed in a drainage gap for filling, in an expanded state, the average thickness of the wall of the clamping balloon except for the joint part of the clamping balloon and other pipelines preferably comprises the following values: 0.01mm to 1mm.

The maximum section perimeter of the clamping balloon represents the maximum value of the perimeter of the outer edge of any section in the expanded state of the clamping balloon, and the ratio of the maximum section edge perimeter of the clamping balloon to the perimeter of the drainage tube comprises: 2 to 100.

According to the general principle, after the clamping balloon is expanded by the filler, any point of the wall of the clamping balloon protrudes outwards along the direction perpendicular to the tangent plane of the point under the condition that the clamping balloon is not constrained, the joint of the clamping balloon and the drainage tube also has the shape and the tendency to protrude outwards of the clamping balloon, when the drainage tube is pulled, the joint of the clamping balloon and the drainage tube protrudes more obviously along the pulling direction, when the protruding part is pulled into the drainage channel, the opening in the drainage channel is expanded and pulled by the protruding part, so that the local tension is increased, and further the local damage is caused. The purpose of the shaped retention balloon is to shape the retention balloon proximally, which is also referred to as a proximal shaped retention balloon.

The shaping strip is a tubular structure with two open ends and arranged inside the clamping balloon, two ends of the shaping strip penetrate through two opposite pipe walls of the clamping balloon and are in sealing connection with the two pipe walls, the shaping strip is of an inelastic tubular structure, the manufacturing materials of the shaping strip usually comprise the flexible materials, in some embodiments, the drainage tube penetrates through the clamping balloon, the drainage tube is fixedly connected with the clamping balloon, and the drainage tube penetrating through the clamping balloon has the same function as the shaping strip.

Because the shaping strip limits the expansion of the clamping saccule, the clamping saccule walls at two ends of the shaping strip are in a concave state, and the drainage tube is connected with the shaping strip through the concave part of the clamping saccule, so that the fixation of the drainage tube and the clamping saccule is realized, and the expansion traction damage of the clamping saccule to the inner opening of the drainage channel is avoided.

The types of the clamping balloon filling material comprise water, air, silicone oil and white oil. Because the viscosity coefficient of the air is small, the use effect is good in the small-caliber fixed communicating pipe. The viscosity coefficient of water, silicone oil and white oil is high, and the movable communicating pipe is suitable for use, and because of the tissue safety of water, in order to avoid the influence of the filler on surrounding tissues after the clamping balloon is broken, the water is adopted as the filler to be safer.

The gas filling material can generate a certain impact effect on surrounding tissues after the sudden rupture of the clamping balloon, so that the air is used as the clamping balloon filling material to control the input pressure, and the preferable value of the filling material pressure in the input clamping balloon comprises 20cm to 500cm of water column.

In some embodiments, the clamping balloon filler comprises air, has a small viscosity coefficient, is easy to input and output, has the disadvantage of easy leakage, and as time goes on, the pressure inside the clamping balloon is reduced, the shaping characteristics of the clamping balloon are lost, and even as the clamping balloon is atrophic, the drainage device is caused to slip out of the drainage channel. Air is therefore mainly used as a fill for a cartridge balloon in drainage devices with a fixed communication tube, usually provided with a fill reservoir. Through the pressure perception to the filler stock bag, whether the inside filler of screens sacculus needs to be replenished is tentatively judged, if need be replenished, can input air through this drainage device's locking device. In other embodiments, the communicating tube is a mobile communicating tube, after the clamping balloon is injected with air, the mobile communicating tube is removed, the air in the clamping balloon is not supplemented any more, in order to maintain the tightness of the clamping balloon to the air as much as possible, the thickness of the clamping balloon is required to be increased, the clamping balloon is made of polar polymer materials such as polyurethane, elastomer containing polar groups, nylon, cyano rubber and the like, and composite material films containing the materials, in particular a co-extrusion composite film containing polyethylene and nylon components, and the embodiment of taking the air as the filling material of the clamping balloon is mainly applied to larger drainage gaps in the space of digestive tracts, bladder, thoracic cavities and abdominal cavities and the like, and allows the hardness and thickness of the wall of the clamping balloon to have a larger value range due to the larger space.

The spacer is an isolation part between the filler inside the clamping balloon and the drainage material in the drainage tube and plays a role in connecting the clamping balloon and the drainage tube. The spacer varies with the different interconnection positional relationships between the drainage tube and the clamping balloon and the inflation and deflation accessory, and in most embodiments, the spacer is often a section of material or structure that is bonded or shared between the clamping balloon and the drainage tube; in some embodiments, a fixed communicating pipe is arranged, the drainage pipe and the communicating pipe are arranged in parallel and are mutually attached together, and the separator comprises a pipe wall and an adhesive between the drainage pipe and the communicating pipe; when the fixed communicating pipe and the drainage pipe are mutually sleeved, the partition piece also comprises a section of drainage pipe or communicating pipe between the fixed communicating pipe and the drainage pipe.

The charging and discharging accessory comprises a fixed communicating pipe and a locking device, and a movable communicating pipe and a locking device; the communicating pipe provides a pipeline through which the filling material in the clamping balloon is filled, and the locking device opens and seals the filling passage of the filling material in the clamping balloon when needed; the communicating pipe is communicated with the clamping saccule.

The fixed communicating pipe can be integrally formed with the clamping balloon, and can be connected and communicated with the clamping balloon after being independently formed, the manufacturing materials of the fixed communicating pipe are selected from materials identical to those of the clamping balloon and the drainage tube, in most embodiments, the fixed communicating pipe inputs clamping balloon filler into the clamping balloon when the drainage device is placed in the fixed communicating pipe, the clamping balloon filler is discharged through the communicating pipe when the drainage device is removed, the passing speed requirement of the filler in the inner part of a communicating pipe lumen is relatively low, based on the fact that the pipe diameter of the communicating pipe is smaller than that of the drainage tube, and the ratio of the circumference of the fixed communicating pipe to the circumference of the drainage tube is 0.05-1; in a special case, in order to maintain the tightness of the drainage channel, the perimeter of the fixed communicating tube is increased to seal the drainage channel, or in a case where the drainage tube passes through the fixed communicating tube, the ratio of the perimeter of the fixed communicating tube to the perimeter of the drainage tube is 1 to 30.

As the lumen of the communicating tube becomes thinner, the resistance increases when the clamp balloon filler is inputted, and preferably, in the drainage device using the fixed communicating tube, the clamp balloon filler has lower resistance using gas.

The external end of the fixed communicating pipe is connected with a flexible material filling material storage bag, and the manufacturing material of the storage bag wall comprises the material of the clamping saccule wall. The storage bag is connected with a luer lock or a sealing block, the filler storage bag has the function of storing filler, and the storage bag has the input capability which can be used at any time when the number of the contents of the clamping saccule is required to be temporarily increased; in another aspect, the filling material storage bag has the function of testing the filling material pressure of the clamping balloon, in the daily use process, professionals can often generally judge the filling material pressure inside the clamping balloon through touching, so as to avoid that the clamping balloon is separated from the drainage cavity after the clamping balloon filling material leaks, and the filling material storage bag is positioned outside the body, and the volume of the filling material storage bag is mainly determined by the carrying convenience degree and the convenience degree for sensing the pressure change of the filling material storage bag, and generally, the volume of the filling material storage bag comprises 2ml to 100ml. In other embodiments, it may be desirable to push more filler to the retention balloon by squeezing the filler reservoir, the retention balloon being expanded and the stent tube connected to the distal wall of the retention balloon being moved distally as the retention balloon expands; when the distal capsule wall of the clamping balloon is pulled, the internal pressure of the clamping balloon rises, the filler in the clamping balloon enters the filler storage capsule, the volume of the clamping balloon is reduced, and the stent tube connected with the distal capsule wall of the clamping balloon is moved proximally.

In general, since the fixed communicating tube has finer structural characteristics compared with the drainage tube, when the broken sleeve is used, in some embodiments, the fixed communicating tube is free from the drainage tube, and the broken sleeve can reach the clamping balloon along the free fixed communicating tube, so that the clamping balloon is broken.

In order to reduce the stimulation or influence of the drainage device in the drainage channel on the drainage channel in the non-drainage state, it is one of the purposes of the present invention to minimize the volume of the implant in the drainage channel, in some embodiments, the communicating tube is removed from the drainage device after the effect of the input filler is completed, and the hole formed after the communicating tube is removed from the clamping balloon needs to be sealed by a sealing block. In embodiments of the present invention in which a mobile communication tube is used, the mobile communication tube is typically used in combination with a sealing block.

The movable communicating tube has a rigid tubular structure, and particularly, a section of communicating tube arranged inside the sealing block has a rigid tubular structure. The strength and the manufacturing raw materials of the movable communicating tube refer to the strength and the manufacturing raw materials of the bracket tube. The thickness ratio of the movable communicating pipe is 0.002-0.12, and the ratio of the perimeter of the outer side edge of the cross section of the movable communicating pipe to the perimeter of the inner side edge of the cross section of the drainage tube is 0.01-0.5. In some embodiments, a mobile communication tube passes through the stent tube, the mobile communication tube having a circumference that is less than the stent tube lumen circumference.

Preferably, in some single tube external expansion embodiments, particularly using drainage devices in the deep parts of the body such as the stomach, duodenum, jejunum, biliary tract, etc., the length of the communicating tube needs to be correspondingly prolonged along with the extension of the drainage channel, and the passing resistance of the filler inside the communicating tube is increased, particularly, the increase of the resistance is more obvious in the embodiment that the filler is white oil and silicone oil with high viscosity coefficient. The preferable scheme comprises properly expanding the circumference of the movable communicating pipe on the proximal pipe wall of the sealing block and using the flexible pipe wall on the premise of ensuring that the movable communicating pipe can pass through the drainage channel; more preferably, the mobile communication tube is connected in series with the bracket tube as a whole, and is particularly suitable for temporarily not requiring drainage from a drainage gap after the drainage device is placed in a body, and only fluid needs to be input, so that the bracket tube and the mobile communication tube are removed from the drainage device together, and the resistance of the filler is smaller when the drainage device is placed due to the reduction of the structure.

As in the present invention where elastomeric polymers are used as sealing blocks, elastomeric polymers are also used in large numbers in conventional catheters, and such materials as elastomeric polymers themselves have intermolecular interactions, including: the mechanical characteristics of the electrostatic force, the induction force, the dispersion force and the hydrogen bond force enable the polymers in the high molecular block to have elastic deformation capability, the compositions of the materials comprise latex, polyurethane, nylon and thermoplastic elastomer, after the sealing block is formed, the movable communicating pipe pierces the sealing block to enter the other side of the sealing block, after filling is input, the movable communicating pipe withdraws from the sealing block, and the high molecules around a channel formed by piercing rebound seal the piercing channel due to the elastic deformation capability, so that the sealing effect is achieved.

The sources of the sealing effect also comprise whether the sealing block material and the filler have polarity or not, and generally, according to the similar principle of compatibility, the sealing performance is poor under the condition that the polarity of the sealing block and the polarity of the filler are the same, and the sealing effect is good under the condition that the polarity of the sealing block and the polarity of the filler are different. The water is a polar substance, the silicone oil, the white oil and the air are nonpolar substances, and the polarity of the sealing material and the filler is different as much as possible when the sealing material and the filler are selected, so that the good sealing property is kept.

Another factor of the sealing effect is the viscosity coefficient of the filler, such as silicone oil and white oil, which increases with increasing molecular weight, and the viscosity coefficient of the flow, which also improves the sealing performance, is smaller than that of liquids such as water, white oil, silicone oil, and the like.

The sealing performance of the clamping saccule and the sealing block to air is improved by filling a small amount of water, silicone oil, white oil and common sealing grease products in the market into the clamping saccule, and the sealing performance of the whole sealing block to air is improved due to the infiltration of the liquid filler to the gap of the sealing block. When the sealing block is a polar polymer substance, water is selected as a sealing reinforcing agent, and when the sealing block is a nonpolar substance, silicone oil, white oil and sealing grease commonly used in the market are selected as sealing reinforcing agents.

When the clamping balloon filler is water or polar liquid such as electrolyte containing water, the sealing performance of the elastic sealing block made of nonpolar polymer substances such as natural rubber, styrene-butadiene rubber, butyl rubber, polyethylene, polypropylene, polystyrene, polytetrafluoroethylene, silicone rubber and thermoplastic elastomer without polar groups is better. On the other hand, in the case of using nonpolar substances such as air, paraffin oil, white oil and the like as the filler, polyamide, polyvinyl alcohol, polyurethane, nitrile polymer, polyvinyl chloride, chloroprene rubber, nitrile rubber polar polymer and the like are used as the elastic sealing blocks, the sealing performance is good, and the nonpolar filler has low diffusion speed in the polar elastic sealing blocks, so that the sealing performance of the elastic sealing blocks is maintained. The polytetrafluoroethylene has the characteristics of good shape following performance due to the special molecular symmetry structure, the repellency to most polar and nonpolar fluids, the expanded polytetrafluoroethylene is difficult to infiltrate, the material used as the sealing block is particularly suitable for a drainage device with liquid fillers, and the preferable implementation structure comprises rubber, nylon and thermoplastic elastomer structures wrapped around the expanded polytetrafluoroethylene due to the poor rebound performance of the expanded polytetrafluoroethylene.

Under the condition of using the movable communicating pipe, the sealing block is separated from the sealing connection position of the clamping balloon wall or the isolating piece, and the connection modes comprise three modes, namely one of the sealing block and the isolating piece, wherein the sealing block is positioned at one side of the inner part of the clamping balloon; secondly, the sealing block is positioned at one side outside the clamping saccule; and thirdly, the sealing block is connected with the clamping saccule or the isolation piece into a whole, wherein the sealing block is positioned at two sides of the clamping saccule or the isolation piece and penetrates through the clamping saccule or the isolation piece.

The movable communicating tube passage is usually manufactured by a puncture mode after the sealing block is molded, and the puncture process is finished before the drainage device is put into the body, especially before the packaging is finished. The process of the movable communicating pipe penetrating through the sealing block comprises the following steps: a length of tubular structure with a tip is pierced through the sealing block, then a mobile communication tube is passed through the sealing block along the tubular structure with a tip, and finally the tubular structure with a tip is withdrawn. The other method for the mobile communication pipe to pass through the sealing block comprises the following steps: the front end of the movable communicating pipe is a tip, the tip is removed after the sealing block is pierced, and the broken end edge formed after the tip is removed is rounded.

The locking device connected with the fixed communicating pipe comprises a luer lock connector, a plug, a clip, an adhesive, a connector with a screw, a sealing block, a valve and a filler storage bag; the valve comprises in particular an arrangement which is opened under depression of the syringe nipple, the valve being closed after the syringe nipple has been moved away due to the resilience of the valve spring mechanism; the luer lock interface comprises a male port and a female port, wherein the proximal male port or the female port of the luer lock is taken down, a clamping saccule filler is input, and the proximal male port or the female port is accessed again; preferably, the filler reservoir is provided with a sealing block or luer lock interface.

In all embodiments adopting the mobile communication pipe, the sealing property of the clamping balloon is required to be destroyed when the drainage device is taken out, the clamping balloon of the drainage device with the top balloon structure can be destroyed by using the support pipe provided by the invention, and the specific mode is that the head end of the support pipe directly breaks the clamping balloon under the action of external force, and the certainty of the destroyed clamping balloon is limited because the head end of the support pipe cannot be designed into a sharp head end, and the preferred scheme is to adopt the clamping balloon destroying cutter with a tip as shown in fig. 2 for destroying the clamping balloon in order to ensure the certainty of the destroyed clamping balloon;

The destroying cutter comprises a pipe part, a metal tip part, a filler intersecting hole and a filler outlet; the pipe part is a rigid pipe, the pipe wall of the pipe head section is provided with a filler intersecting hole, and the pipe head section is in an unconstrained state and comprises a straight tubular structure or an arc tubular structure in shape. Preferably, a transition member conical portion is provided between the metal tip portion and the tube portion.

The metal tip of the breaking tool has smaller axial length dimension to avoid influencing the turning of the breaking tool along with the support pipe, preferably, the total length of the metal part is not more than one sixth of the circumference of the pipe, the conical part of the breaking tool is mainly used for fixing the metal tip and connecting the pipe of the breaking tool, smooth transition from the tip to the pipe is realized, the conical part is provided with an outwards protruding arc surface, the materials for manufacturing the conical part and the pipe comprise materials for manufacturing the support pipe, the conical part can also be used as the front end of the pipe of the breaking tool, the pipe structure is gradually contracted into a convex conical structure, and the total length of the conical structure and the metal tip which are jointed together is not more than one fourth of the circumference of the pipe. To increase the exit velocity of the fill of the retention balloon when the metal tip pierces the retention balloon, in some embodiments the conical portion surface and/or the tube portion surface is provided with grooves extending parallel to the axis of the breaker tool. The metal species of the metal tip portion include stainless steel, aluminum alloy, and the like; manufacturing a broken cutter pipe part, referring to a support pipe of the drainage device, wherein the outer diameter of the broken cutter pipe part is smaller than the inner diameter of the support pipe of the drainage device; the center of the tube part of the destroying cutter is provided with a hollow tube cavity, and the tube wall of the tube part is provided with a plurality of round or elliptic holes

In other embodiments, the drainage tube passes through the clamping balloon, the clamping balloon surrounds the head of the drainage tube, the breaking cutter extends out along the support tube in a straight way and is not easy to break the clamping balloon, on the basis of the fact, in some embodiments, the breaking cutter is provided with a curved conical part and a tube front section, the turning radius of the central axis of the tube front section is 0.5 to 2 times of the circumference of the outer side face of the tube wall of the tube part of the breaking cutter, and the ratio of the length of the curved part of the tube front section to the circumference of the tube part of the breaking cutter comprises 0.5 to 2. The outer surface of the pipe part of the breaking cutter is provided with length scales, and the pipe wall thickness ratio of the pipe part of the breaking cutter is 0.002 to 0.12.

The method comprises the following steps of (1) destroying a cutter to use, and confirming that the drainage device is used and needs to be removed; step 2, inserting the breaking cutter into the support tube, preferably, withdrawing the support tube from the drainage tube, if necessary, breaking the external part of the drainage tube, loading the breaking cutter into the support tube, setting the tip of the breaking cutter to be positioned near the opening at the front end of the support tube, and extending the head end of the support tube forwards to prop against the separator or prop against the clamping balloon; step 3, pulling the drainage tube, pushing the breaking cutter forwards, wherein the breaking cutter pierces through the separator or the clamping balloon, and at least one part of the filler enters the lumen of the breaking cutter through a hole arranged on the front section tube wall of the breaking cutter and flows out of the drainage tube or the drainage body; in some embodiments, when the drainage tube passes through the clamping balloon and the head end of the support tube extends forward of the inner section of the drainage tube, the head end of the drainage tube cannot collide with the clamping balloon or the isolation piece, in this case, preferably, the destroying cutter has an arc-shaped front section design, and the using method comprises the following steps: step 1, confirming that the drainage device needs to be removed; step 2, extending the head end of the stent tube with the breaking cutter to the near-center section of the tubular separator; and 3, pushing forward a breaking cutter with an arc-shaped tubular structure front section, wherein after the breaking cutter extends out of the front end of the support tube, the tip of the breaking cutter turns to one side according to the inherent radian of the front section of the breaking cutter, the tip of the breaking cutter pierces a spacer or a clamping balloon positioned at the side of the drainage tube, and at least one part of the filler enters a breaking cutter lumen through a filler intersecting hole arranged on the wall of the front section of the breaking cutter and flows out of the body. In some embodiments, the retention balloon filler may overflow into the drainage gap after the retention balloon is destroyed to achieve the same effect; in the drainage device with the bag penetrating structure, the clamping saccule is positioned around the head of the drainage tube, the isolating piece is positioned at the side of the support tube, the preferred scheme comprises using a destroying cutter with an arc-shaped structure at the head section, preferably, the cutter extends out of the support tube from a destroying cutter outlet at the side wall of the support tube, the outlet comprises an ellipse, and the long axis of the ellipse outlet is parallel to the long axis of the support tube. When the head end of the support tube reaches the head end of the drainage tube, the outlet of the broken cutter on the side wall of the support tube is positioned at the position of the isolation piece connected with the drainage tube by the clamping saccule, the broken cutter with radian at the front end is pushed forward, and the cutter extends out of the outlet of the broken cutter on the side wall of the support tube according to the inherent radian and pierces the isolation piece. The ratio of the perimeter of the outlet of the breaking cutter on the side wall of the support tube to the perimeter of the support tube is 0.5 to 2, and the perimeter of the outlet of the breaking cutter is larger than the perimeter of the tube part and the conical part of the breaking cutter.

The broken sleeve shown in fig. 1 comprises a rigid outer sleeve and a rigid inner sleeve, wherein the outer sleeve comprises a pipe body and a metal blade, the metal blade is arranged on the inner side of the pipe wall at the front end of the outer sleeve, the metal blade faces the central direction of the pipe cavity of the outer sleeve, and the plane of the blade is axially parallel to the head end of the outer sleeve; the outer side of the front end pipe wall of the inner sleeve is provided with a protection groove matched with the metal blade. The number of the metal blades comprises 1, 2 and 3, and preferably, the metal blades are fixed on a common metal annular base or a metal C-shaped base firstly and then fused with a high polymer outer sleeve; the outer side of the front end pipe wall of the inner sleeve is provided with a protection groove matched with the metal blade; preferably, the length and depth of the groove of the inner sleeve are respectively larger than the length and depth of the metal blade (the depth of the blade and the width of the blade are the same meaning words), the front end of the inner sleeve extends to the front side of the front end of the outer sleeve, preferably, a hole is arranged on the pipe wall of the outer sleeve, a groove parallel to the axial direction of the outer sleeve is arranged on one side of the pipe wall cavity of the outer sleeve, and the distribution range of the groove on the outer sleeve and the hole on the pipe wall of the outer sleeve on the pipe wall comprises the front section, the middle section and the rear section of the outer sleeve. Preferably, the holes on the outer sleeve are round, oval, rectangular and slit. The embedded state refers to a state that the metal blade of the outer sleeve and the metal blade protection groove of the inner sleeve are mutually embedded. Preferably, in the state of the broken sleeve embedding, the inner sleeve wall and the outer sleeve wall on the near side of the metal blade distribution section are provided with continuous notches which extend to the tail end of the outer sleeve of the inner sleeve, and the notches of the inner sleeve and the outer sleeve are mutually overlapped when the inner sleeve and the outer sleeve are embedded together; the radian value of the continuity gap on the broken sleeve comprises 0-60 degrees, wherein the 0-degree gap represents that the gap is a potential gap, and the edges of the continuity gap are butted together to be contacted with each other under the natural placing state of the inner sleeve, so that the 0-degree gap can be separated and enlarged under the action of external force; more preferably, the indentations of the inner and outer cannulas in the range of 10mm to 20mm proximal to the metal blade distribution section comprise two, the purpose of the double indentations being to more conveniently pass a fixed communicating tube or drainage tube through the metal blade distribution section of the broken cannula. In a further preferred embodiment, the inner and outer sleeves of the metal blade distribution section are provided with overlapping 0 ° notches in the fitted state, through which notches flexible communication tubes or drainage tubes can be plugged from the side into the interior of the fitted inner sleeve outer sleeve.

Method of using a broken sleeve: the inner sleeve and the outer sleeve of the broken sleeve are mutually embedded, the fixed communicating pipe or the drainage tube passes through the metal blade distribution section of the inner sleeve and the outer sleeve and is pulled out from the side notch of the inner sleeve and the outer sleeve in the embedded state, and then the communicating pipe or the drainage tube is moved into the inner sleeve in the embedded state through the side notch of the inner sleeve and the outer sleeve and passes out of the tail end of the inner sleeve. The front end of the broken sleeve is pushed to the clamping balloon along the wall of the drainage tube or the wall of the fixed communicating tube, the front end of the broken sleeve is confirmed to be contacted with the clamping balloon by hand feeling and/or by observing scales of the drainage tube or the fixed communicating tube, the inner sleeve of the broken sleeve is withdrawn in the near-heart direction, the outer sleeve of the broken sleeve is fixed, the drainage tube or the fixed communicating tube is pulled, the inner edge of the front end of the broken sleeve breaks the wall of the clamping balloon, and the filler of the clamping balloon flows out of the clamping balloon; and (3) pulling the tail end of the drainage tube or the communicating tube to pull the drainage device out of the drainage channel.

The drainage device communicating pipe and the locking device comprise the following two forms: a mobile communication pipe and a locking device, wherein the locking device comprises a sealing block, the sealing block is in sealing connection with a clamping balloon wall or a spacer, at least one section of the mobile communication pipe is of a rigid tubular structure, and the rigid tubular structure is in sealing and movable communication with the clamping balloon through the sealing block; b the fixed communicating pipe and the locking device comprise, the fixed communicating pipe is communicated with the clamping saccule, preferably, the pipe wall of the fixed communicating pipe is continued with the wall of the clamping saccule, and the locking device connected with the fixed communicating pipe comprises any one or the combination of two of the following structures: luer lock male port, luer lock female port, plug, clip, screwed port, sealing block, valve, and filler storage bag. In some embodiments using a fixed communication tube, the communication tube is an integrally formed structure with the retention balloon. Preferably, in some embodiments in which the fixed communicating tube uses flexible materials, the clamping balloon filler comprises air, and because the viscosity coefficient of the air is minimum, the quick passing can be completed only by a small gap, the materials required for manufacturing the fixed communicating tube are less, and the influence on the drainage channel is small; because air has a penetrating effect in the polymer material, the gas in the clamping balloon is necessarily less and less along with the time, preferably, in the embodiment that the clamping balloon filler comprises air, the locking device comprises a filler storage balloon, the function of the storage balloon comprises rough detection of the clamping balloon pressure, and then whether the clamping balloon filler needs to be added or not is determined, and if necessary, the filling storage balloon is extruded to have the effect of temporarily expanding the clamping balloon. In embodiments using a mobile communication tube, the click balloon filler is preferably a liquid-based filler with little osmotic diffusion loss. More preferably, the filler reservoir is provided with a sealing block or valve.

In some embodiments, the mobile communication tube is connected in series with a stent tube that is located proximal to the mobile communication tube, which are in communication with each other. Under the connection mode that the two are mutually inserted, the structure that the two are mutually sleeved and embedded together seals all drainage inlets of the stent tube head section, after the filling material is input through the stent tube and the mobile communicating tube, the stent tube and the mobile communicating tube are pulled out of the drainage device together, the stent tube is put into the drainage tube at the later time, and before the stent tube is put into the drainage tube, the embodiment can finish the fluid conveying to the drainage gap without using the stent tube; the stent tube can be replaced when needed, and the stent tube can be a previously used stent tube which is spliced with the mobile communicating tube or can be a matched stent tube. Preferably, in the embodiment in which the bracket tube is used in series with the communicating tube, the bracket tube is provided with a single axial opening at the trailing end only.

The connection mode of the head of the drainage tube and the clamping saccule in the drainage device comprises the following steps: a top balloon connection, in some embodiments, the top end of the head of the drainage tube is connected with the clamping balloon, in particular, the head end of the drainage tube is directly connected with the surface of the wall of the clamping balloon, or the head end of the drainage tube is inserted into the clamping balloon but does not pass through the clamping balloon, and the wall of the drainage tube is connected with the wall of the clamping balloon; b a transcapsular connection, in some embodiments, the drain head passes through a clamping balloon surrounding the drain head; c, connecting the capsule, wherein the head of the drainage tube surrounds the clamping balloon, the head of the drainage tube comprises a spherical saccular structure, and the spherical saccular structure surrounds the periphery of the clamping balloon; preferably, the drainage tube head spherical balloon structure is in direct connection with at least one point of the retention structure of the retention balloon. Specifically, the spherical sac-like structure of the head of the drainage tube comprises a fiber braiding or weaving net; the side balloon is connected, the side wall of the drainage tube is connected with the clamping balloon wall, or the side wall of the drainage tube is attached to the front section tube wall of the fixed communicating tube, so that the clamping balloon is indirectly connected.

The positional relationship between the communicating tube and the drainage tube includes: a, at least one section of communicating pipe runs inside the drainage tube, which can be understood as that the drainage tube surrounds the section of communicating pipe, and the connection mode is called wrapping connection for short; b in some embodiments, at least one section of the drainage tube runs inside the communicating tube, and the communicating tube is a fixed communicating tube, in such embodiments, the drainage tube passes through the clamping balloon and the fixed communicating tube together, and also can be understood as that the drainage tube passes through the communicating tube and is simply connected in a penetrating way; and c, the drainage tube and the communicating tube are respectively connected with the clamping saccule, the drainage tube and the communicating tube are not sleeved with each other, preferably the tube walls of the drainage tube and the communicating tube are close to each other and attached to each other, and the drainage tube and the communicating tube can be understood as being parallel to each other and are simply connected in parallel.

In some embodiments, a rigid delivery catheter is provided that includes a high molecular polymer, the delivery catheter being open at both ends. The overall physical properties of the rigid delivery catheter and the fabrication of the stent tube of the drainage device are referenced. The stent tube is temporarily withdrawn from the drainage device before use, the rest part of the drainage device is accommodated in the conveying catheter, the process can be completed in a factory, the front end of the conveying catheter is pushed to a drainage gap, the stent tube is used for pushing the inner structure of the conveying catheter forwards, and after the clamping balloon is pushed to the drainage gap, the filling material is input to expand the clamping balloon and the conveying catheter is withdrawn; preferably, the delivery catheter has at least two tearable pre-cuts longitudinally distributed along the delivery catheter, the pre-cuts extending to an inner and outer edge of the proximal port of the delivery catheter and to an outer edge of the distal port, respectively; preferably, the precut line depth is 30% to 90% of the wall thickness of the conveying catheter at the cut position, the ratio of the precut line width to the wall thickness at the cut position of the precut line comprises 5% to 80%, the proximal end of the conveying catheter is divided into two parts by two precut lines, preferably, a piece of holding patch for tearing is attached to the proximal port of each part, and the manufacturing components and manufacturing process of the holding patch comprise the manufacturing components and manufacturing process of the tube body.

The invention also includes a medical kit comprising a drainage device and at least one component selected from the group consisting of: negative pressure or vacuum source, extension tube, fluid collection container, sterile filter, lubricant, syringe, suture, luer lock interface male port, luer lock interface female port, plug, clip, anastomotic tube, loach guide wire, zebra guide wire, expansion tube, push tube, and guide catheter.

The extension tube or the anastomotic tube is used for being connected and communicated with a drainage tube in the drainage device; the circumference of the connecting port of the extension tube or the anastomotic tube is equal to the circumference of the tube wall at one position inside the outlet of the drainage tube, or the circumference of the tube wall at one position inside the connecting port of the extension tube or the anastomotic tube is equal to the circumference of the drainage tube, the two conditions can enable the two to be mutually sleeved, and further, the materials at the mutually-butted position have elasticity, so that better joint friction force is provided.

The loach guide wire is a spiral running steel wire or other metal alloy wires, and is widely used in medical instruments such as a venipuncture set, a stomach tube set, a thoracocentesis drainage tube set, an abdominal cavity puncture drainage tube set and the like. The zebra guide wire is a double-strand spiral winding guide wire comprising a metal core, and has a softer design within the range of 2cm of the head end.

The expansion tube is a rigid polymer tube or a metal tube with gradually increased thickness from the front end to the tail end, and particularly comprises a rigid polymer tube with gradually increased thickness of an inner tube wall with the front end of 30mm, wherein the circumference of the tube cavity at the front end of the expansion tube comprises 3mm to 6mm, and the length of the expansion tube comprises 100mm to 300mm. Such a dilating catheter has been widely used in medical devices such as venipuncture sets, thoracocentesis drainage tube sets, and abdominal cavity puncture drainage tube sets.

The guide catheter comprises a commercially available guide catheter for coronary angiography or a vascular interventional therapy catheter, and the guide catheter can pass through a guide hole at the blind end of the drainage tube to achieve the same function of a guide wire.

The invention also discloses a method for manufacturing the drainage device, which comprises the following steps: step 1, manufacturing a basic pipeline (shown in figure 3); step 2 comprises one or a combination of at least two of the following steps, such as: the basic pipeline is arranged and jointed, provided with a hole, provided with a movable communicating pipe, provided with a locking device and provided with a drainage tube bracket.

Further, the basic pipeline in the method comprises the following steps: a balloon-tube structure basic pipeline and a tubular structure basic pipeline; the basic pipeline of the sac tube structure comprises: the bag part and the pipe part are connected and communicated with each other, the structure of the bag part comprises a single bag structure or a double bag string formed by two bag structures, and the two bag structures of the double bag string are connected and communicated with each other through a pipe between the bags; the basic pipeline of the balloon pipe structure comprises the following basic pipelines: single-bag tube, double-pass double-bag tube, single-blind single-bag tube; the tubular structure basic pipeline comprises a straight pipe and a blind end pipe; the blind end pipe is of a tubular structure with a blind end; the straight pipe comprises a pipe with two open ends; the main pipeline is made of flexible materials, the length of the wall of the flexible materials accounts for 95-100% of the total length, and the inflexible part is mainly used at the joint part. In most embodiments, the bladder portion in the primary conduit is used to make a retention balloon, and in some embodiments the bladder portion is used to make a drain bulb. In some embodiments the tube-in-tube portion of the primary tubing of the balloon tube structure is used to make part or all of a drain tube, a communication tube, a shaping bar.

The maximum cross section edge circumference of the bag part in the basic pipeline is larger than the circumference of the pipe part in the basic pipeline, the circumferences of the pipe part and the inter-bag pipe in the basic pipeline of the bag pipe structure are not required to be consistent, the A, B pipe circumference ratio of the basic pipeline in the illustration is only one example, and the circumferences of the pipe structures at two sides of the bag part in the basic pipeline are not required to be symmetrical.

For the purpose of the invention, the two-way single-bag pipe and the two-way double-bag pipe in the basic pipeline of the bag pipe structure are respectively named as a pipe A and a pipe B, and the pipe A is positioned at the left side of the illustration, namely the front of the drainage device, in the beginning stage of operating the basic pipeline under the condition that no special description is made; the B tube is to the right of the illustration, i.e., behind the drainage device, and the description of the A or B tube does not include the middle tube of the two-way, two-balloon tube; according to the same principle, the double bags in the double-pass double-bag pipe are respectively named as an A bag and a B bag, the bags of the single-pass double-bag pipe and the single-blind double-bag pipe, which are directly connected with a pipe part with an open port outside, are named as B bags, and the other bag is named as an A bag, wherein the A bag is positioned at the left side in the illustration and represents the front side of the drainage device for the purposes of the invention; the B sac is positioned on the right side and represents the rear side of the drainage device. The length of the tube portion in the base line comprises 50mm to 7000mm, the circumference of the tube portion ranges from 5mm to 80mm, and the thickness of the balloon wall or tube wall in the base line comprises from 0.001mm to 2mm.

Further, in some embodiments, to reduce local damage to the junction between the drainage channel and the drainage gap by the clamping balloon, a proximal shaping clamping balloon needs to be manufactured, and the manufacturing method includes: shaping and setting the two-way single-bag pipe: step 1, firstly, arranging a continuous capsule hole or a capsule wall filler intersecting hole (one of the two holes), wherein the continuous capsule hole is formed in the following way: a connecting bag hole is arranged at one part of a B pipe of the double-pass single-bag pipe, and the distance between the connecting bag hole and the root of the B pipe is smaller than the length of the shaping strip; or a capsule wall filler intersecting hole is arranged at the capsule part of the two-way single-capsule tube; step 2, the opening of the B pipe of the double-pass single-bag pipe is turned inwards, and the B pipe passes through the bag part of the double-pass single-bag pipe and is at least in sealing connection with the root part of the A pipe; the shaping strip comprises a tubular structure between the root parts of the A, B pipes; in some embodiments, after the inverted tube B of the two-way single-balloon tube is sealingly engaged with the root portion of the tube a of the two-way single-balloon tube, the tube a and/or tube B continues to extend in the direction of the opening of the tube a, becoming the communication tube of the drainage device.

In addition, the method for shaping the double-pass single-balloon catheter comprises the steps of using a blind end catheter, firstly setting a continuous balloon hole or a balloon wall filler intersecting hole (one of the two is arranged), setting the continuous balloon hole, and setting the continuous balloon hole at one position of the blind end catheter or setting the balloon wall filler intersecting hole at the balloon part of the double-pass single-balloon catheter; and 2, a section of the B tube of the double-pass single-bag tube is turned inwards towards the bag part of the double-pass single-bag tube, the length of the section comprises 20 to 80 percent of the circumference of the tube wall of the section, the blind end tube sequentially passes through the root parts of the A tube and the B tube of the double-pass single-bag tube, the connecting bag hole is positioned between the root parts of the A, B tubes, and the blind end tube is in sealing joint with the root parts of the A, B tubes. The shaping strip comprises a section of blind end pipe wall between the root parts of the two-way single-bag pipe A pipe and the B pipe.

Setting the distance between two connecting points of the shaping strip and the clamping balloon as X, and inputting a certain test pressure filler into the clamping balloon in the connecting state of the shaping strip, wherein the distance between the two connecting points is X1; when the molded strip is closed at the broken end after being cut off, filling materials are input into the clamping balloon under the same test pressure, and the distance between two connecting points is X2; the shaping ratio of the clamping balloon with shaping function is expressed by dividing a parameter X1 by X2, and preferably, the preferred value of the shaping ratio comprises 10 to 95 percent; in the case of a non-elastic snap balloon, the positive pressure test pressure inside the balloon comprises more than 30cm of water. The shaping ratio of the non-elastic clamping balloon mainly depends on the inherent shapes of the clamping balloon and the shaping strips, the shaping ratio of the elastic clamping balloon is related to the pressure of the input filling material in use, and as the input pressure is increased, the larger the expansion multiple of the clamping balloon is, the smaller the number of the shaping ratio is, and the greater the sinking degree of the shaping clamping balloon is.

The two-way double-bag pipe can be understood as two-way single-bag pipes which are connected in series, and in the manufacturing process of the clamping saccule, the two-way double-bag pipe can be used for replacing the two-way single-bag pipe completely, and the two-way double-bag pipe double-bag string is used for replacing the two-way single-bag pipe bag part, and the pipe parts A, B pipe at two sides of the two-way double-bag pipe are used for replacing the pipe parts A, B pipe at two sides of the two-way single-bag pipe.

The filler entering the shaping balloon inlet comprises: the capsule wall filler intersecting holes and the shaping strip connecting capsule holes are positioned on the capsule wall of the basic pipeline capsule part, and the capsule wall does not comprise a shaping strip structure; the molding strip connecting bag hole comprises a hole arranged on the wall of the molding strip pipe;

for the purposes of the present invention, the molding strip filler intersecting holes and the linking bag holes represent the same hole.

The path for the filler filling through the shaped strip-to-bag aperture comprises:

a, filling is input through the distal end of the shaping bar, in which case the proximal end of the shaping bar connecting bag hole is sealed, the distal end of the shaping bar is communicated with the communicating pipe, or the communicating pipe is a structure of the shaping bar extending distally;

b, filling is input through the proximal end of the molding strip connecting capsule hole:

in the case, the distal end of the molding strip connecting bag hole is sealed, the proximal side of the molding strip connecting bag hole is in sealing connection with the blind end pipe, a mobile communicating pipe is arranged in the charging and discharging accessory, the mobile communicating pipe penetrates through the blind end of the blind end pipe and a sealing block connected with the blind end of the blind end pipe, the filler is input into the molding strip pipe, and the filler enters the bag part through the molding strip connecting bag hole;

or the drainage device is provided with a movable communicating pipe, a sealing block matched with the movable communicating pipe and the molding strip connecting bag hole are connected in a sealing way inside the clamping saccule of the drainage device, and the movable communicating pipe of the drainage device is communicated with the clamping saccule by penetrating through the sealing block inside the molding strip.

The path for filling the filler through the wall filler through hole comprises: the filler is filled through a fixed communicating pipe and a locking device which are communicated with the capsule wall filler communicating hole; or the filler is input through a movable communicating pipe, and the movable communicating pipe passes through the capsule wall filler communicating hole and a sealing block which is in sealing connection with the capsule wall filler communicating hole and is communicated with the clamping balloon.

From the whole, the drainage device with the shaping screens sacculus is connected in the outward appearance structure of this screens sacculus pit with flexible drainage tube, and this pit is fixed in the drainage passageway in the opening part of drainage clearance by the drainage tube tractive, has reduced the damage of screens sacculus to drainage passageway in drainage clearance opening part to the maximum extent.

The manufacturing method of the basic pipeline bag pipe structure comprises the steps of manufacturing half of the basic pipeline respectively, and then forming a basic pipeline after the two half structures are combined, wherein a butt joint line of the two half parts of the basic pipeline is preferably positioned between the front part and the rear part of the basic pipeline, and the butt joint line is preferably perpendicular to the long axis of the basic pipeline; preferably, the device is turned outwards or inwards from one end of the basic pipeline, so that the inner surface and the outer surface of the wall of the whole basic pipeline are mutually converted, and redundant structures at joints generated by butt joint are turned into the basic pipeline; preferably, the processing of the double-pass double-bag pipe with the double-bag structure comprises the steps of firstly processing the double-pass single-bag pipe and then connecting and communicating the two double-pass single-bag pipes in series.

For the purpose of the invention, the folding comprises two forms of inward folding and outward folding, wherein the inward folding means that the capsule wall or the pipe wall is turned inwards under the action of external force at one part of the basic pipeline, the outer side surface of the original wall is turned to be a turned inner side surface, and the inner side surface of the original wall faces the inner side surface of the adjacent non-turned part after being turned; the other form of turnover is that the pipe wall or the balloon wall of the basic pipeline pipe part is turned outwards under the action of external force, the inner side surface of the original wall is turned to be the turned outer side surface, and the outer side surface of the original wall faces the outer side surface of the adjacent non-turned part after being turned. Further, the basic pipeline with two open ends is completely converted along with the turning process. In the process of turning over, the annular line of the tube wall or the capsule wall with the conversion of the inner side surface and the outer side surface is a turning-over line.

The processing method of the basic pipeline comprises the following steps: molding methods, molding aids, and localized reinforcement.

The molding manufacturing method comprises one of the following methods and a combination of at least two methods: compression molding, plastic suction molding, injection blow molding, extrusion blow molding, stretch blow molding, coating molding, lamination molding and winding molding, especially comprising blow molding and stretch molding, wherein the process comprises the steps of firstly processing raw materials into pipe blanks and then carrying out blow molding and stretch molding;

The auxiliary measures include one of the following measures and a combination of at least two methods: heating, pressurizing, ultraviolet irradiation, radioactive ray irradiation, vacuum and inert gas protection atmosphere;

the local enhancement method comprises the following steps: a portion of the primary tubing is stretch blow molded, coated, cut, precipitation reinforced, wound, and laminated.

The flexible material application part in the manufacturing method disclosed by the invention comprises the following steps: all or part of any one structure of the clamping saccule, the drainage tube, the fixed communicating tube and the isolating piece.

The manufacturing method of the clamping balloon connection structure comprises the following steps of arranging and jointing basic pipelines: wherein, the pipeline a is sleeved, and two basic pipelines without continuity are fully or partially overlapped; b, turning over the opening of the pipeline inwards, turning over one end opening of a bag or a pipe in the basic pipeline inwards, enabling the original inner side pipe wall of the turned over pipe wall to face the inner side pipe wall of the adjacent non-turned over pipeline, enabling the original outer side pipe wall of the turned over pipe wall to become the inner side wall of the basic pipeline after turning over, enabling a new pipe cavity to be communicated with the original pipe cavity to form a new passage, and enabling a turning over line to form a new pipeline opening edge; c, the blind end of the pipeline is turned inwards, the blind end of the bag or the pipe in the basic pipeline is pushed to the inside of the structural cavity, the edge of the sunk part of the blind end forms a turning line, the pipe wall around the blind end is turned inwards, the original pipe wall inner side of the turned pipe wall is attached to the adjacent pipe wall inner side of the non-turned pipe, the original outer side of the turned pipe wall is turned to form the pipe wall inner side of the turned pipe wall, the new pipe cavity and the original pipe cavity are not communicated because of the separation of the original blind end, and the turning line forms the opening edge of the new pipeline; d, turning over the opening of the pipeline, turning over one end opening of the bag or the pipe in the basic pipeline outwards, attaching the turned over section pipeline with the external side of the pipeline adjacent to the non-turned over section after turning over the original external side of the pipeline, turning over the original internal side of the pipeline wall of the turned over section to form the external side of the pipeline wall of the turned over pipeline, turning over the line to form the opening edge of the pipeline after turning over, and communicating the pipeline with the original pipeline after turning over; the e pipe protrudes to the bag, the root pipe wall of the pipe part in the basic pipeline of the bag pipe structure is inwards folded to enable the original inner side surface of the inwards folded tubular structure to be opposite to the inner side surface of the bag wall of the bag part, the original outer side surface of the inwards folded tubular structure is attached to the other part of the non-folded outer side surface after the inwards folded tubular structure is folded, the original pipeline is still communicated with the pipeline after the protrusion, and the bag wall of the saccule does not fold; f line engagement, comprising: the joint of the pipeline opening and the opening, the joint of the pipeline wall and the pipeline wall, and the joint of the pipeline opening and the pipeline wall opening; g, folding and thickening: firstly, one end of a section of pipe needing to be thickened is inserted into the adjacent pipeline and pushed forward to cause the adjacent pipeline to be turned inwards, the turned-inwards section forms a double-layer protruding part protruding to the outer side of the pipeline needing to be thickened, and the protruding part covers the outer part of the pipe needing to be layered; secondly, one end of the first section of pipe needing to be thickened is outwards expanded to push the inclusion adjacent pipe to cause the adjacent pipe to be outwards turned, the outwards turned section forms a double-layer protruding part protruding to the inner side of the pipe needing to be thickened, and the protruding part covers the inner part of the pipe needing to be layered; h, connecting in series through sealing blocks: one part of the sealing block is connected with one part of the basic pipeline, and then the sealing block is connected with the other pipeline.

A drainage method comprises the following steps of 1, putting the drainage device in, 2, conveying a clamping balloon filler to the clamping balloon and sealing the clamping balloon; step 3, drainage and stopping drainage, wherein the drainage process comprises the following steps: the stent tube is moved to the narrow part of the drainage channel and expands the narrow part of the drainage channel from the inside of the flexible drainage tube; stopping drainage, removing the stent tube from the narrow part of the drainage channel, collapsing and closing the flexible drainage tube positioned at the narrow part of the drainage channel, ending the drainage process or performing drainage to enter a slow process, and keeping the drainage device in a standby state; and 4, pulling out the drainage device, destroying the tightness of the clamping balloon, removing the filling of the clamping balloon, and pulling out the drainage device.

The method for placing the drainage device comprises the following steps: a) Using a stent tube to prop against the top end of the drainage tube or the clamping balloon from the inside of the drainage tube to drive the clamping balloon into the drainage gap, and further, using a guide wire or a guide catheter, wherein the drainage device is placed into the drainage gap along the guide wire or the guide catheter; b) The head end of the support tube is connected with the movable communicating tube in series, the movable communicating tube passes through the sealing block, the support tube and the movable communicating tube support against the sealing block together, and the clamping saccule connected with the sealing block is brought into the drainage gap along with the pushing of the support tube to the drainage gap direction; c) Wrapping at least a part of the drainage device by using a delivery catheter, delivering the clamping balloon to the drainage cavity through the delivery catheter, pushing the clamping balloon into the drainage cavity by using a support tube or a pushing tube, and withdrawing the delivery catheter and the pushing tube; d) The drainage device is jacked into the drainage gap by using a pushing tube to prop against the blind end of the drainage tube head, the circumference of the pushing tube is smaller than that of the cavity of the drainage tube head, and the method is particularly suitable for the drainage device with a rigid drainage tube head (the method can be understood as the drainage device that a bracket tube is fixed on the drainage tube head); e) The clamping saccule and other structures of the drainage device are placed in the stomach by one of the four methods, and then reach a specified drainage gap in the digestive tract along with the peristalsis of the digestive tract, particularly the digestive tract reaching the farther part of the pylorus; f) The clamping saccule and other structures of the drainage device are placed in the abdominal cavity through one of the four methods a, b, c, d, and the clamping saccule placed in the abdominal cavity reaches the lowest part of the abdominal cavity under the action of gravity.

The process of inputting the filler through the communicating tube and closing the clamping balloon includes two modes: a, inputting the filler through the mobile communicating pipe, pulling out the mobile communicating pipe, and automatically sealing a gap left after the mobile communicating pipe is pulled out by a sealing block; b opening a locking device connected with the fixed communicating pipe, inputting the filler through the fixed communicating pipe, and closing the locking device connected with the fixed communicating pipe.

The drainage step includes two ways of moving the stent tube to the narrow portion of the drainage channel: under the non-drainage state, the stent tube is positioned at the position close to the center of the narrow position of the drainage channel or near the drainage channel, and the stent tube can be moved from the outside of the drainage channel to the narrow position of the drainage channel and pass through the narrow position of the drainage channel to finish drainage because the wall of the drainage tube is provided with a flexible tube wall; b the drainage device is in a non-drainage state, the support tube is positioned in a drainage gap, the support tube is fixed at the head of the drainage tube, the support tube structure is provided with a resettable arrangement, the resettable arrangement particularly comprises that the support tube is of an elastic spiral structure, the filler can be extruded to a filler storage bag and is provided with a clamping balloon filler mainly of air, when one point of the drainage tube body is pulled, the flexible tube wall of the proximal drainage tube can be folded and folded, the mobility of the drainage tube is provided, the support tube with the elastic spiral structure is straightened, a part of the support tube is moved to the narrow position of a drainage channel, the drainage channel is opened, and the drainage process is completed.

Methods of removing the stent tube from the stenosed site of the drainage channel include two approaches: a) Under the expansion mode that the stent tube is expanded from the outside (near side) of the narrow part of the drainage channel, the stent tube is pulled out of the drainage tube, and as the flexible drainage tube wall has the collapsible and stretching performance, the stent tube is clamped and pulled out of the narrow part of the drainage channel from the outside of the drainage tube wall, the drainage tube wall of the narrow part of the drainage channel collapses, and the drainage process is ended or enters a slow drainage stage; b) Under the mode that the stent tube expands from the inside of a drainage gap, after drainage is finished, the tube wall of a drainage tube which is pulled is loosened, a drainage stent connected with the head end of the drainage tube is moved out from a drainage channel to the direction of a drainage cavity, the removed power comprises a resettable arrangement, particularly the stent tube which comprises an elastic spiral structure is retracted out of the drainage channel, and a filler storage bag is extruded to convey filler to a clamping balloon, so that the stent tube connected with the distal balloon wall of the clamping balloon moves to the drainage gap and is withdrawn from the narrow part of the drainage channel.

The method for breaking the sealing performance of the clamping balloon comprises the following steps: a) The head end of the stent tube is pushed from the inside or the outside of the drainage tube along the wall of the drainage tube which is pulled and is contacted with the clamping balloon, and the weak point or the maximum stressed part of the wall of the clamping balloon breaks along with the increase of the forward pushing force of the stent tube; b) Using a breaking cutter, placing the breaking cutter into a support tube, calculating the relative length of the drainage tube and the drainage support according to hand feeling or observation scales, confirming that the head end of the support tube reaches the front end of the drainage tube, fixing the drainage tube and the support tube, pushing the breaking cutter out of the support tube forwards, and enabling the tip of the breaking cutter to pierce a clamping saccule wall or a separation piece; c, using a broken sleeve, embedding the inner sleeve and the outer sleeve of the broken sleeve with each other, pushing the broken sleeve to the clamping balloon along the wall of the drainage tube or the wall of the fixed communicating tube, confirming that the front end of the broken sleeve contacts the clamping balloon by hand feeling or observing the scales of the drainage tube or the fixed communicating tube, withdrawing the inner sleeve of the broken sleeve towards the near-heart end, pulling the drainage tube or the fixed communicating tube, pushing the outer sleeve of the broken sleeve forwards, and damaging the wall of the clamping balloon by the edge at the inner side of the front end of the broken sleeve, wherein the filler flows out of the clamping balloon; d, opening the locking device of the fixed communicating pipe or breaking the sealing property of the fixed communicating pipe in vitro, and removing the filler out of the clamping saccule.

In the embodiment, the naming principle and the structural relation under the naming are as follows:

the first two words represent the relationship between the head of the drainage tube and the clamping balloon in four ways: in the first mode, a top balloon is used for indicating that the top end of a drainage tube is connected with a clamping balloon, the top end of the drainage tube can extend into the clamping balloon but does not penetrate through the clamping balloon, and the inlet of the drainage tube is positioned at the proximal drainage tube section of the clamping balloon; in the second mode, the puncture bag is used for indicating that the head of the drainage tube is penetrated out of the clamping balloon, and the inlet of the drainage tube is positioned at the near side and/or the far side of the clamping balloon; in a third way, the balloon, representing the drainage tube head Cheng Qiuxing, surrounds the clamping balloon, with the drainage tube inlet located on the surface of the clamping balloon proximal drainage tube bore section or spherical head. In a fourth mode, the side balloon, the head of the drainage tube is positioned at one side of the clamping balloon, and the inlet of the drainage tube is positioned at the head of the drainage tube beyond the contact part of the drainage tube and the clamping balloon.

The relation between the drainage tube and the communicating tube is shown in the 3 rd and the 4 th words, and the three modes are as follows: in the first mode, the communicating tube is wrapped by the drainage tube, and the communicating tube penetrates through the drainage tube; in the second mode, the drainage tube passes through the communicating tube, and in the mode, the drainage tube always passes through the clamping balloon at the same time; the third mode is connected in parallel, the drainage tube and the communicating tube are respectively connected with the clamping balloon, the connecting points are positioned at different positions of the clamping balloon, and the drainage tube and the communicating tube are not sleeved with each other.

The 5 th and 6 th words indicate whether the communicating tube is a mobile communicating tube and thus whether the in-out drainage channel tube is a double tube or a single tube, including two ways, the first way: the drainage device comprises a double tube, a drainage tube and a fixed communicating tube, wherein the inside of a narrow part of a drainage channel contains two pipelines when the drainage device is placed into a non-drainage state; in the second mode, the single tube is arranged in the drainage device, when the drainage device is placed in a non-drainage state, only one drainage tube is arranged at the narrow part of the drainage channel, and the movable communicating tube is moved out of the drainage device after the step of inputting the filler is completed.

The 5, 6 and 7 words are used to indicate whether the stricture site is being dilated outwardly from the drainage lumen or inwardly from outside the body along the drainage channel. The drainage device comprises two modes, wherein the first mode is an internal expansion mode, the front section of the support tube is connected with the front end of the drainage tube, the drainage device is provided with a support tube which can be reset, and when the drainage tube is pulled, the rigid support tube and the head of the drainage tube are pulled into the narrow section of the drainage channel, and the drainage channel is expanded from the inside of a drainage gap; in the second mode, the stent tube is pushed into the narrow part of the drainage channel from outside the body, and the narrow part of the drainage channel is expanded from outside. The expansion methods employed in the devices of the present invention are all denoted as external expansion, unless specifically stated as internal expansion or external expansion

In the present invention, in the front part of the "apparatus" and "method", one or more groups of 1 st and 2 nd, 3 rd and 4 th, 5 th and 6 th, 7 th and 8 th of 9 th words in the naming method are added, and the mentioned fields represent structural features under the naming of the group or groups of fields, and the meaning of the remaining non-mentioned fields represent all the possibilities listed in the present invention. The meaning of other fields added in the naming of the drainage device is explained and explained with reference to the specification.

Drawings

FIG. 1 is a schematic view of the construction of a broken sleeve according to the present invention.

FIG. 2 is a schematic view of the construction of the breaker tool of the present invention.

Fig. 3 is a schematic diagram of the basic pipeline structure of the invention.

Fig. 4 is a schematic structural view of the single tube drainage device connected in parallel with the top sac.

FIG. 4B is a schematic structural view of a single tube drainage device with a shaping strip connected in parallel with a top bag according to the present invention

Fig. 5 is a schematic structural view of the single tube drainage device connected with the top bag.

Fig. 6 is a schematic structural view of the drainage device of the top bag-connected single-tube shaping clamping balloon of the invention.

FIG. 7 is a schematic view of the structure of the balloon shunt single tube external expansion drainage device of the present invention.

Fig. 8 is a schematic structural view of the encapsulation-packaging single-tube drainage device of the invention.

Fig. 9 is a schematic structural view of a top sac parallel double-tube drainage device of the invention.

FIG. 10 is a schematic structural view of the capsule-connecting double-tube drainage device of the invention.

Fig. 11 is a schematic structural view of a top bag connecting double-tube drainage device of the invention.

FIG. 12 is a schematic structural view of a side-balloon parallel double-tube drainage device of the present invention.

Fig. 13 is a schematic structural view of a bag-penetrating bag-connecting single-tube drainage device.

Fig. 14 is a schematic structural view of a balloon-penetrating parallel double-tube drainage device.

Fig. 15 is a schematic structural view of the balloon-penetrating parallel-connected single-tube drainage device of the invention.

Fig. 16 is a schematic structural view of a through-bag and through-connection double-tube drainage device of the invention.

Fig. 17 is a schematic diagram of a manufacturing method 1 of the through-bag and connecting double-tube molding clamping balloon drainage device.

Fig. 18 is a schematic diagram of a manufacturing method 2 of the through-bag and through-connection double-tube molding clamping balloon drainage device.

Fig. 19 is a schematic view of a through-the-balloon dual tube dual balloon drainage device of the present invention.

FIG. 20 is a schematic view of a capsulorhexis through double tube endodilation drainage device of the present invention.

FIG. 21 is a schematic view of the structure of the drainage tube of the present invention.

Fig. 22 is a schematic view of the structure of a delivery catheter of the present invention.

Detailed Description

The protection of the present invention is not limited to the following examples. Variations and advantages that would occur to one skilled in the art are included in the invention without departing from the spirit and scope of the inventive concept, and the scope of the invention is defined by the appended claims.

In FIGS. 1a-1d, a 501-0 notch; 510-an inner sleeve; 511-blade-mating grooves; 520-outer sleeve; 521-metal blade. The following are respectively from left to right: the cross section of the head end of the inner sleeve 510; the cross section of the head end of the outer sleeve 520; cross sections of the inner sleeve head end and the outer sleeve head end in the embedded state; and the cross sections of the inner sleeve head end and the outer sleeve head end are in a jogged state with 0-degree notches.

In fig. 2, 400-tube section; 401-metal tips; 402-filler vias; 403-filler outlet; 404-conical section.

In FIG. 3, 901-single balloon tube; 902-a two-way single-balloon tube; 903-straight pipe; 904-blind end tube; 905-double pass double balloon tube; 907-single-pass double-balloon tube; 908-single blind double balloon tube; 909-single blind single balloon tube.

In fig. 4, a 100-click balloon; 12-spacers; 200-drainage tube; 201-drainage tube inlet; 202-a drainage tube outlet; 210-drainage tube head; 310-mobile communication pipe; 331-sealing block; 600-stent tube; 601-stent tube inlet; 602-stent tube outlet; 902-a two-way single-balloon tube; 904-blind end tube.

In fig. 4B, a 100-click balloon; 14-shaping the strip; 140-continuous capsule holes; 310-mobile communication pipe; 331-sealing block; 201-drainage tube inlet; 202-a drainage tube outlet; 200-drainage tube; 600-stent tube; 601-stent tube inlet; 602-stent tube outlet; 902-a two-way single-balloon tube; 904-blind end tube.

In fig. 5, a 100-click balloon; 12-spacers; 200-drainage tube; 201-drainage tube inlet; 202-a drainage tube outlet; 310-mobile communication pipe; 331-sealing block; 600-stent tube; 601-stent tube inlet; 602-stent tube outlet; 904-blind end tube; 901-single balloon tube.

In fig. 6, a 100-click balloon; 14-shaping the strip; 140-continuous capsule holes; 200-drainage tube; 201-drainage tube inlet; 202-a drainage tube outlet; 210-drainage tube head; 310-mobile communication pipe; 331-sealing block; 600-stent tube; 601-stent tube inlet; 602-stent tube outlet; 902-a two-way single-balloon tube; 904-blind end tube.

In fig. 7, a 100-click balloon; 201-drainage tube inlet; 202-a drainage tube outlet; 211-a drainage tube head ball section; 212-a drainage tube head section; 220-drainage tube body; 310-mobile communication pipe; 331-sealing block; 600-stent tube; 601-stent tube drain inlet; 602-stent tube outlet; 901-single balloon tube.

In fig. 8, a 100-click balloon; 201-drainage tube inlet; 202-a drainage tube outlet; 210-drainage tube head; 220-drainage tube body; 310-mobile communication pipe; 331-sealing block; 600-stent tube; 601-stent tube inlet; 602-stent tube outlet; 901-single balloon tube.

In fig. 9, a 100-click balloon; 12-spacers; 200-drainage tube; 201-drainage tube inlet; 202-a drainage tube outlet; 210-drainage tube head; 220-drainage tube body; 320-fixed communicating tube; 330-locking means; 600-stent tube; 601-stent tube inlet; 602-stent tube outlet; 902-a two-way single-balloon tube; 904-blind end tube.

In fig. 10, a 100-click balloon; 201-drainage tube inlet; 202-a drainage tube outlet; 211-a drainage tube head ball section; 320-fixed communicating tube; 330-locking means; 600-stent tube; 601-stent tube inlet; 602-stent tube outlet; 901-single balloon tube.

In fig. 11, a 100-click balloon; 201-drainage tube inlet; 202-a drainage tube outlet; 210-drainage tube head; 220-drainage tube body; 320-fixed communicating tube; 330-locking means; 600-stent tube; 601-stent tube inlet; 602-stent tube outlet; 901-single balloon tube.

In fig. 12, a 100-click balloon; 200-drainage tube; 201-drainage tube inlet; 202-a drainage tube outlet; 215-drainage tube attachment points; 218-a pilot hole; 320-fixed communicating tube; 330-locking means; 901-single balloon tube; 904-blind end tube.

In fig. 13, a 100-click balloon; 200-drainage tube; 201-drainage tube inlet; 202-a drainage tube outlet; 218-a pilot hole; 310-mobile communication pipe; 331-sealing block; 600-stent tube; 601-stent tube inlet; 602-stent tube outlet; 902-a two-way single-balloon tube; 904-blind end tube.

In fig. 14, a 100-click balloon; 200-drainage tube; 201-drainage tube inlet; 202-a drainage tube outlet; 210-drainage tube head; 218-a pilot hole; 320-fixed communicating tube; 330-locking means; 332-filler reservoir; 600-stent tube; 601-stent tube inlet; 602-stent tube outlet; 902-a two-way single-balloon tube; 903-straight pipe; 904-blind end tube.

In fig. 15, a 100-click balloon; 200-drainage tube; 201-drainage tube inlet; 202-a drainage tube outlet; 218-a pilot hole; 310-mobile communication pipe; 331-sealing block; 600-stent tube; 601-stent tube inlet; 602-stent tube outlet; 902-a two-way single-balloon tube; 904-blind end tube.

In fig. 16, a 100-click balloon; 201-drainage tube inlet; 202-a drainage tube outlet; 210-drainage tube head; 218-a pilot hole; 220-drainage tube body; 214-a distal connection point; 217-proximal connection point; 320-fixed communicating tube; 330-locking means; 3311-uniting the balloon tube; 600-stent tube; 601-stent tube inlet; 602-stent tube outlet; 902-a two-way single-balloon tube; 904-blind end tube; 909-single blind single balloon tube.

In fig. 17, a 100-click balloon; 140-continuous capsule holes; 200-drainage tube; 201-drainage tube inlet; 202-a drainage tube outlet; 218-a pilot hole; 320-fixed communicating tube; 330-locking means; 900-fold line; 902-a two-way single-balloon tube; 904-blind end tube.

In fig. 18, a 100-click balloon; 140-continuous capsule holes; 201-drainage tube inlet; 202-drainage tube body; 210-drainage tube head; 218-a pilot hole; 220-drainage tube body; 320-fixed communicating tube; 330-locking means; 902-a two-way single-balloon tube; 903-straight pipe; 904-blind end tube; 934-ring connection.

In fig. 19, a 100-click balloon; 120-an inter-capsular tube; 201-drainage tube inlet; 210-drainage tube head; 218-a pilot hole; 220-drainage tube body; 320-fixed communicating tube; 330-locking means; 601-stent tube inlet; 602-stent tube outlet.

In fig. 20, a 100-click balloon; 200-drainage tube; 201-drainage tube inlet; 218-a pilot hole; 230-pulling the secondary tube; 231-pull point; 320-fixed communicating tube; 330-locking means; 332-filler reservoir; 600-stent tube.

In fig. 21, a 100-click balloon; 12-spacers; 200-drainage tube; 201-drainage tube inlet; 202-a drainage tube outlet; 300-communicating pipe; 330-locking means; 600-stent tube; 601-stent tube inlet; 602-stent tube outlet.

In fig. 22, 701-tube; 702-precutting line; 703-holding the patch.

The top balloon as shown in fig. 4 is connected in parallel with a single tube drainage device, in some embodiments, different parts of the clamping balloon are respectively connected with a communicating tube and a drainage tube, the communicating tube is a movable communicating tube, and the head end of the drainage tube is connected with the clamping balloon. In this kind of embodiment, the spacer is located the different positions of screens sacculus with the sealing block, and the advantage is that moulding strip sets up more freely, and the sealing block can be located inside the screens sacculus, and the sealing block also can set up in the outside of screens sacculus, and both modes are difficult to influence screens sacculus and drainage passageway internal orifice contact comfort level. The defect is that a conveying catheter is required to protect the movable communicating pipe when the drainage device is pushed towards the drainage gap direction, after the drainage device is placed in the drainage device, a clamping balloon filler is input into the clamping balloon, the movable communicating pipe and the conveying catheter are withdrawn, and a bracket pipe is placed in the drainage device; preferably, the drainage tube end is provided with a detachable clasp or an elastically expandable clasp. When the stent tube is used alone without using a delivery catheter for pushing and placing, the mobile communication tube 310 and the stent tube 600 push the clip balloon into the drainage gap in parallel, and the mobile communication tube is easily detached.

The device comprises a basic pipeline double-pass single-bag pipe, a blind end pipe, a sealing block, a bracket pipe and a movable communicating pipe, wherein a clamping balloon is manufactured by a bag part in the double-pass single-bag pipe; the manufacturing of the communicating pipe, the manufacturing of the movable communicating pipe, the manufacturing of the blind end pipe and the manufacturing of the isolating piece, wherein the movable communicating pipe passes through a sealing block, and the sealing block is in sealing connection with the root part of the double-pass single-bag pipe A; manufacturing a drainage tube, namely manufacturing a blind end tube attached to the root of the double-pass single-bag tube B; the blind end pipe body is provided with a drainage pipe inlet, and the drainage device is provided with a support pipe.

Preferably, in the basic pipeline shown in fig. 4B, the two-way single-bag pipe B is turned inwards to make a shaping strip, a connecting bag hole is arranged, the blind end of the blind end pipe is hermetically jointed with the proximal section of the connecting bag hole of the shaping strip, a hole is arranged on the blind end pipe body, a sealing block is hermetically connected to the far side of the connecting bag hole of the shaping strip, and the movable communicating pipe passes through the sealing block in a movable sealing manner.

In the single tube external expansion embodiment of the top bag package as shown in fig. 5, in such an embodiment, before the drainage device is placed, the mobile communication tube passes through the drainage tube and the stent tube arranged inside the drainage tube, and then passes through the sealing block to be communicated with the clamping balloon cavity, and the process is preferably set before leaving the factory. The sealing block is arranged on one side of the inside of the clamping balloon or one side of the outside of the clamping balloon of the isolating piece and is in sealing connection with the clamping balloon; alternatively, the sealing block blends with the spacer during fabrication and becomes part of the spacer; alternatively, the sealing block passes through the spacer; or one end of the sealing block is connected with the clamping saccule, and the other end is connected with the drainage tube.

The processing method of the top bag-connected single-tube external expansion drainage device shown in fig. 5 comprises the following steps:

the first method is as follows: the single-balloon tube, the movable communicating tube, the sealing block and the bracket tube are used, and the clamping balloon is manufactured by the single-balloon tube balloon part; the drainage tube is made of a single-bag tube part, and a drainage material inlet and a drainage material outlet are arranged on the single-bag tube part; the movable communicating pipe is communicated with the single-bag pipe bag part through a bracket pipe and the sealing block; the method has simple structure and high manufacturing efficiency.

The second method comprises a single-bag pipe, a blind end pipe, a movable communicating pipe, a sealing block and a bracket pipe; the clamping saccule is made of a single saccule tube saccule part; the drainage tube is manufactured by a blind end of a blind end tube which is connected to the root of a single-bag tube part in a sealing way, and a drainage tube inlet is arranged on the wall of the blind end tube; the spacer comprises a blind end of a blind end pipe; the sealing block is arranged and is connected in the front end pipe cavity of the blind end pipe in a sealing way; and placing the support pipe and the movable communicating pipe.

The drainage device shown in fig. 6, the embodiment comprises a single-tube drainage device wrapped by a top bag of a proximal shaping clamping balloon, the shaping clamping balloon is provided with a shaping strip and a connecting bag hole, the wall of the proximal section of the connecting bag hole is in sealing connection with the blind end of a drainage tube, a sealing block in the drainage device is in sealing connection with the blind end of the drainage tube, the head end of a movable connecting tube passes through the sealing block and the blind end of the drainage tube to enter the shaping strip and be communicated with the shaping strip, the distal end of the shaping strip is closed, and the closed mode comprises adding a plug, directly heating and welding or vibrating welding the shaping tube, sleeving the blind end of another blind end tube, and the like.

The top bag package with the shaping clamping saccule and the single tube external expansion drainage device comprises a double-pass single-bag tube and a blind end tube, and the shaping clamping saccule with shaping strips and connecting saccule holes is manufactured by using the double-pass single-bag tube (as described above). The blind end of the blind end pipe is hermetically connected to the proximal section of the shaping strip continuous capsule hole, and the wall of the blind end pipe is provided with a hole; closing the distal end of the molding strip; the sealing block is connected in a sealing way in the blind end of the blind end pipe; a movable communicating pipe and a bracket pipe are arranged.

The capsule parallel connection single-tube external expansion drainage device shown in fig. 7 comprises a sealing block and a movable communicating pipe, wherein the sealing block is connected with the clamping balloon, the drainage tube and the movable communicating pipe are positioned at two sides of the clamping balloon, the head part of the drainage tube comprises a ball section and a tube section, the ball section of the head part of the drainage tube surrounds the clamping balloon, and the ball section and/or the tube section of the head part of the drainage tube is provided with a drainage tube inlet; the connection between the ball section and the clamping ball bag comprises structural connection or clamping indirect connection, in the clamping indirect connection mode, the clamping ball bag can be sent into the head ball section of the drainage tube through a hole formed in the head ball section of the drainage tube in a non-filling state, after the clamping ball bag is input with a filler, the volume of the clamping ball bag is enlarged, and the clamping ball bag cannot be separated from the hole formed in the head ball section of the drainage tube, so that the clamping ball bag and the drainage tube play a fixing role.

The manufacturing method of the encapsulation parallel connection single-tube drainage device comprises the following steps: the device comprises a movable communicating pipe, a sealing block, a bracket pipe and two single-bag pipes, wherein the two single-bag pipes are respectively a first single-bag pipe and a second single-bag pipe, the bag part of the first single-bag pipe and/or the root part of the pipe part is provided with a drainage pipe inlet, and the bag part of the second single-bag pipe is sent into the bag part of the first single-bag pipe through a hole arranged in the bag part of the first single-bag pipe; the clamping balloon comprises a second single-balloon tube balloon part; the drainage tube comprises a first single-sac tube sac part and a tube part; the separator comprises a second single-balloon catheter balloon portion balloon wall; sealing block sets up: the root of the second single-bag tube is connected with the sealing block in a sealing way; and (3) setting a communicating pipe: the movable communicating pipe passes through the sealing block and is communicated with the second single-bag pipe bag part; placing a bracket tube; the shaping strip does not need to be manufactured. The drainage device manufactured by the method can freely rotate in the spherical head section of the drainage tube after the drainage device is placed.

In the embodiment of the encapsulation-wrapped single-tube drainage device shown in fig. 8, the head of the drainage tube is provided with a spherical head section, the clamping balloon is wrapped in the spherical head section of the drainage tube, no structural connection exists between the spherical head section and the spherical head section of the drainage tube, and the clamping balloon after being expanded by the filler has a volume far greater than the passing capacity of the drainage tube and is fixed on the head section of the drainage tube; the sealing block is fixed on the wall of the clamping saccule in a sealing way; the head ball section and/or the tube section of the drainage tube are provided with a drainage tube inlet; part of the movable communicating pipe runs inside the drainage tube and the bracket tube, and the movable communicating pipe passes through the sealing block and is communicated with the clamping balloon.

The manufacturing concept of the embodiment is that two single-bag pipes are nested together in the same direction, and the device has the characteristics of simple structure and low cost.

The capsule-wrapped single-tube drainage device shown in fig. 8 is manufactured by two single-tube drainage tubes, namely a first single-tube drainage tube and a second single-tube drainage tube, wherein the first single-tube drainage tube is sleeved outside the second single-tube drainage tube, and the tube parts of the two single-tube drainage tubes are opened towards the same direction; the drainage tube comprises a first single-bag tube bag part and a tube part which are sleeved outside, and holes are arranged on the bag part and/or the tube part; the clamping balloon comprises a second single-balloon tube balloon part; placing a bracket tube; mobile communicating pipe and sealing block set up: comprises the sealing block and the root part of the second single-bag tube part which are connected in a sealing way, and the movable communicating tube passes through the bracket tube and the sealing block and is communicated with the second single-bag tube part.

The top bag parallel connection double-tube drainage device shown in fig. 9, the drainage tube head of the drainage device is in sealing connection with the clamping balloon, the drainage device charging and discharging accessory comprises a locking device and a fixed communicating tube, one end of the fixed communicating tube is connected and communicated with the clamping balloon, the other end of the fixed communicating tube is in sealing connection with the locking device, and the fixed communicating tube and the drainage tube are respectively connected to different parts of the clamping balloon.

The manufacturing method of the top sac parallel connection double-tube drainage device shown in fig. 9 comprises the steps of using a double-pass single-sac tube, a locking device, a bracket tube and a blind end tube, wherein the blind end tube is provided with a hole.

The method comprises the following steps: the drainage tube comprises a double-pass single-bag tube and a blind end tube, wherein the blind end tube is attached and fixed at the root of a double-pass single-bag tube B, the clamping balloon comprises a bag part of the double-pass single-bag tube, the drainage tube comprises the blind end tube, the communicating tube comprises a double-pass single-bag tube A, and the separator comprises a blind end of the blind end tube; a stent tube and a locking device are arranged.

Further, a two-way single-balloon tube is used for manufacturing a proximal shaping clamping balloon, a B tube of the two-way single-balloon tube has a sufficient length, the B tube passes through the bag part of the two-way single-balloon tube to be in sealing joint with the root part of the A tube after being turned inwards, the A tube or the B tube of the two-way single-balloon tube continues to extend distally to form a fixed communicating tube, the outer side port of the fixed communicating tube is connected with a locking device, a tubular structure between the root parts of the A tube and the B tube of the two-way single-balloon tube is a shaping strip, the shaping strip is provided with a connecting bag hole, and the connecting bag hole is arranged before the B tube of the two-way single-balloon tube turns inwards; the blind end of the blind end pipe is in sealing connection with the shaping strip at the proximal section of the shaping strip connecting capsule hole, and a drainage tube inlet is arranged on the proximal pipe wall at the joint of the blind end pipe and the shaping strip. The clamping saccule comprises a double-pass single-saccule tube saccule part, and the fixed communicating tube comprises a part which passes through the double-pass single-saccule tube saccule part and extends to a far distance after the double-pass single-saccule tube B is folded, or comprises a double-pass single-saccule tube A; the drainage tube comprises a blind end tube; the locking device and the stent tube are configured, preferably, the locking device comprises a luer lock male port and/or female port, a plug, a clip, a sealing block, a filler storage bag, and a combination of the two of the above locking devices (the top bag with a shaped clamping balloon and double tube drainage device described in the text of the paragraph above is not illustrated, and can be deduced according to fig. 9).

The biggest advantage in this embodiment is that drainage structure is simple, and the implant is few in the drainage clearance, and the support pipe can exert the guide effect well, and it is convenient to put into and take out.

In this embodiment, the two tubes of the two-way single-balloon tube portion may have different tube wall circumferences, so that the circumference of the tube portion in the basic pipeline for preparing the communicating tube is generally smaller than the circumference of the tube portion for preparing the drainage tube in order to reduce the volume of the implant in the drainage channel; in some embodiments, where it is desirable to maintain the drainage channel sealed from drainage flow in the non-drainage state, the perimeter of the communication tube may be properly enlarged, even beyond the perimeter of the drainage tube, which may be pre-designed with different A, B tube perimeters during the design and fabrication of the base line. The flexible communicating pipe with the enlarged perimeter can be stuffed up the drainage channel under the expansion effect of the clamping saccule filling material and has certain shape following performance, for example, under the condition of drainage of the thoracic cavity and the abdominal cavity, the condition of preventing the drainage object between the drainage pipe wall and the drainage channel from exuding is required to be more tightly prevented, and the flexible communicating pipe with the enlarged perimeter can be more suitable for the requirement. The two pipelines of the drainage device can be mutually dissociated, and particularly, at least one section of the outer sides of the two pipelines is mutually stuck or welded together, so that the drainage device is more compact and easier to place. When two pipelines with inconsistent circumferences are connected, the pipeline can be subjected to heating expansion stretching and heating necking treatment through simple physical stretching.

The encapsulation package of fig. 10 is even double-barrelled drainage device, and the drainage tube head includes the ball section to and complete package screens sacculus, should fill and put the annex and include locking device and fixed communicating pipe, and the one end of this fixed communicating pipe is linked together with this screens sacculus, and the other end of this fixed communicating pipe is connected with this locking device leakproofness, and this communicating pipe at least a portion walks in this support intraduct, and the support intraduct is located drainage tube pipe wall inboard.

The manufacturing of the capsule connecting double tube shown in fig. 10 comprises two single-capsule tubes, namely a first single-capsule tube and a second single-capsule tube, wherein the capsule part and the tube part of the first single-capsule tube are provided with holes, the first single-capsule tube is sleeved outside the second single-capsule tube, the opening directions of the two single-capsule tube parts are consistent, the clamping balloon comprises the second single-capsule tube capsule part, and the separator comprises the second single-capsule tube capsule part and part of the tube part; the fixed communicating pipe comprises a second single-bag pipe part and is connected with the locking device; the drainage tube comprises a first single-balloon catheter balloon portion and a catheter portion. Preferably, the proximal end of the fixed communicating pipe in the drainage device passes through the drainage tube outlet, the side wall of the fixed communicating pipe is in sealing connection with the drainage tube outlet, and a hole is arranged on the side wall of the drainage tube and is connected with a section of pipeline to be used as a connecting pipe of an external pipeline of the drainage tube.

The top bag connecting double-tube drainage device shown in fig. 11 is further processed on the basis of the capsule connecting double-tube drainage device shown in fig. 10, and comprises that a head ball section of a drainage tube in the capsule connecting double-tube drainage device shown in fig. 10 is attached and fixed on a clamping balloon wall, or a front section of a head tube section of the drainage tube is attached and connected to a front section of a fixed communicating tube (not labeled in the figure); the remaining manufacturing processes of the top bag connecting double-tube drainage device shown in fig. 11 are the same as those of the capsule connecting double-tube drainage device shown in fig. 10

A drainage device.

In the capsule or the top capsule-connected double-tube drainage device shown in fig. 10 or 11, the stent tube moves along between the fixed communicating tube and the drainage tube, can be constrained and guided by the drainage tube and the fixed communicating tube together, can minimize damage to a drainage channel, simultaneously reduces the limitation on the perimeter of the inlet of the drainage tube, and can increase the perimeter of the inlet of the drainage tube by being larger than the perimeter of the cross section of the head end of the stent tube under the condition that large-particle drainage is needed to be drained.

As shown in fig. 12, the side-balloon parallel-connected double-tube drainage device, in some embodiments, at least one portion of the drainage tube head is connected to a clamping balloon and/or a fixed communicating tube, and the drainage tube head end extends from one side of the clamping balloon beyond the clamping balloon to the far side of the clamping balloon. The drainage device with the side bag structure has a simple structure, and is particularly suitable for manufacturing a drainage perfusion device mainly for the input purpose such as a stomach tube. The design concept of the side-sac double-tube drainage device is derived from the double-tube drainage of the top sac, and on the basis of the structure of the top sac, a part of the head of the drainage tube continuously passes over the clamping saccule from the side direction and the far side. The near end of the fixed communicating pipe is connected with the locking device, and the far end thereof is communicated with the clamping saccule

The manufacturing process comprises the steps of using a single-bag pipe and a blind end pipe, wherein the pipe wall at one position of the front section of the blind end pipe is attached to a drainage pipe attachment point with the bag wall of the bag part of the single-bag pipe, and further, the drainage pipe attachment point also comprises a connection point between one side of the pipe wall of one section of the blind end pipe and the side wall of the pipe part of the single-bag pipe. The bracket tube is arranged in the blind end tube, and the proximal end of the single-bag tube part is connected with the locking device; the front section of the blind end pipe is provided with a drainage pipe inlet, and the opening of the blind end pipe is a drainage pipe outlet; the fixed communicating pipe comprises a single-bag pipe part; the clamping balloon comprises a single-balloon tube balloon part; the drainage tube comprises a blind end tube; preferably, the front end of the blind end pipe is provided with a guide hole.

Further, a single-pass double-balloon tube is used for replacing the single-balloon tube, in the embodiment, the blind end tube is attached to at least one balloon in the double-balloon structure, the attachment mode comprises sticking, welding and binding, and the drainage device after the single-pass double-balloon tube replaces the single-balloon tube is named as a side-balloon and double-tube double-balloon drainage device. Due to the existence of the double-sac structures, the drainage device has a bidirectional fixing effect, and the relative position of the double-sac structures on the body can be adjusted by changing the length of the inter-sac tube between the double-sac structures.

In some embodiments, as shown in fig. 13, the drainage tube passes through a retention balloon that surrounds a drainage tube head section, the drainage tube head section comprising at least a balloon front section and a balloon section, the balloon section being equivalent to a section of the spacer, the balloon front section being located on the front side of the retention balloon, the balloon front section comprising a hole section and a blind end. The communicating opening of the communicating pipe and the clamping saccule comprises a saccule connecting hole which is positioned on the wall of the isolating piece, and the isolating piece has the function of a shaping strip.

In the use process of the drainage tube, the drainage tube passes through the clamping balloon, and drainage objects can enter the drainage tube through the hole section of the front section of the balloon, so that the drainage tube can finish the drainage process even under the condition that the clamping balloon is closely contacted with the drainage channel at the drainage gap opening. In this embodiment, the front end of the drainage tube stretches out of the front side of the clamping balloon, when the stent tube enters the front end of the drainage tube in use, the drainage material directly completes the entering process through the inlet of the drainage tube at the front side of the clamping balloon, so that the defect of large resistance when the drainage material is drained from the proximal hole section of the clamping balloon under the condition that the contact between the clamping balloon and the drainage channel opening is relatively close is avoided, and particularly, the situation that the drainage or the filling process needs to be completed as soon as possible, for example, urine in the bladder is drained out of the bladder rapidly in the implementation process of catheterization, and the comfort of a user is improved.

The guiding performance is good, because the support pipe can directly prop against the blind end of the drainage tube, the connecting component is sequentially driven to push towards the drainage gap direction, and the front end of the support pipe and the blind end of the drainage tube are well fixed, so that the placement process is favorably carried out smoothly. Under the condition of placing the device, as the sealing block is positioned on the side surface of the support tube, a protruding part is formed at the overlapping position of the sealing block and the support tube in the placing process, the placing difficulty and the damage risk to a drainage channel are increased, and in order to reduce the protruding degree of the protruding part at the overlapping position of the sealing block and the support tube, a concave tube wall structure is arranged at the overlapping position of the support tube matched with the sealing block, or a hole is arranged on the tube wall of the support tube at the overlapping position, and the circumference of the hole is close to that of the sealing block; after the drainage device is placed in the drainage gap, the support tube is rotated or retracted, so that the sealing block is not overlapped with the concave or hole on the support tube, and the influence on the drainage process is small.

In the bag penetrating mode, the porous structure of the front section of the head bag of the drainage tube is beneficial to improving the softness of the head of the drainage tube, and more preferably, the head part of the drainage tube is made of a mesh material woven or woven by a fiber material.

The bag-penetrating bag-connecting single-tube drainage device shown in fig. 13, wherein the filling accessory comprises a sealing block and a movable communicating pipe, the sealing block is in sealing connection with the clamping balloon, and the movable communicating pipe is in movable sealing communication with the clamping balloon through the sealing block; the position where the sealing block is connected with the clamping balloon comprises a spacer, the movable communicating pipe passes through the inside of the drainage tube, passes through the spacer and the sealing block and then is communicated with the clamping balloon, and normally the movable communicating pipe runs between the outside of the support tube and the inside of the drainage tube. The gap where the mobile communication tube passes through the spacer is equivalent to the communication hole on the molding strip.

The bag-penetrating bag-connecting single-tube drainage device shown in fig. 13 comprises a double-pass single-bag tube, a blind end tube, a bracket tube, a sealing block and a movable communicating tube, wherein one part of the outer side wall of the front section of the blind end tube is connected with the sealing block in a sealing way, and the movable communicating tube is arranged to penetrate through the wall of the blind end tube and the sealing block from the inside of the blind end tube; then the blind end pipe is in sealing connection with the root parts of the A, B two pipes of the double-pass single-bag pipe, the sealing block is positioned between the root parts of the two pipes, and the shaping ratio of the clamping saccule is controlled by controlling the distance between the root parts of the two pipes of the double-pass single-bag pipe A, B; finally, arranging a drainage tube inlet on the tube wall of the blind end tube far from the connection part of the blind end tube and the root part of the double-pass single-balloon tube A tube; placing the stent tube. Preferably, a section of pipe wall at the root of the double-pass single-balloon pipe B is turned inwards towards the balloon part of the double-pass single-balloon pipe, and then is connected with the blind end pipe in a sealing way, so that the number of the proximal structures of the clamping balloon is reduced.

The two-tube drainage device connected in parallel through the bag as shown in fig. 14 is one type of the two-tube drainage device, the filling and discharging accessory comprises a fixed communicating tube, one end of the fixed communicating tube is communicated with the clamping balloon, the communicating position is positioned on the clamping balloon wall (the filling material communicating hole of the balloon wall) of the non-isolation piece, and the other end of the fixed communicating tube is connected with the locking device. Preferably, the fixed communication tube proximal end is in communication with a filler reservoir, and the filler reservoir is connected to a sealing block or luer lock interface.

The through-balloon parallel-connected double-tube drainage device shown in fig. 14, wherein a drainage tube passes through the clamping balloon, the clamping balloon surrounds one section of the drainage tube, and the distal section of the drainage tube is provided with a drainage tube inlet.

Fig. 14 shows the manufacture of a balloon-penetrating parallel double-tube drainage device: comprises a double-pass single-sac tube, a blind end tube, a bracket tube, a locking device and a straight tube. Firstly, the distal end of the straight tube is connected and communicated with the proximal capsule wall of the double-pass single-capsule tube, and the proximal end of the straight tube is connected with a locking device which preferably comprises a filler storage capsule; then the blind end pipe is connected with the root parts of the A, B two pipes of the double-pass single-bag pipe in a sealing way, and the shaping ratio of the clamping saccule is controlled by controlling the distance between the root parts of the two pipes of the double-pass single-bag pipe A, B; finally, arranging a drainage tube inlet on the tube wall of the blind end tube far from the connection part of the blind end tube and the root part of the double-pass single-balloon tube A tube; placing the stent tube. Preferably, a section of pipe wall at the root of the double-pass single-balloon pipe B is turned inwards towards the balloon part of the double-pass single-balloon pipe, and then is connected with the blind end pipe in a sealing way, so that the number of the proximal structures of the clamping balloon is reduced.

The drainage device with a through-bag parallel connection single tube drainage device shown in fig. 15 is provided with a movable communicating pipe which passes through the clamping balloon wall and a sealing block in sealing connection with the balloon wall, the movable communicating pipe is communicated with the clamping balloon, the stent tube is arranged in a drainage tube, the drainage tube passes through the clamping balloon, the clamping balloon surrounds a section of the drainage tube, and a drainage tube inlet is arranged at the distal section of the drainage tube; additionally, a proximal section of the drainage tube is provided with a drainage tube inlet.

The manufacturing of the capsulorhexis parallel connection single tube drainage device shown in fig. 15: comprises a double-pass single-bag pipe, a blind end pipe, a bracket pipe, a sealing block and a movable communicating pipe; the manufacturing process comprises the following steps: the sealing block is in sealing connection with the near side wall of the bag part of the double-pass single-bag pipe, and the movable communicating pipe passes through the near side wall of the bag part of the double-pass single-bag pipe and the sealing block; then the blind end pipe is connected with the root parts of the A, B two pipes of the double-pass single-bag pipe in a sealing way, and the shaping ratio of the clamping saccule is controlled by controlling the distance between the root parts of the two pipes of the double-pass single-bag pipe A, B; finally, arranging a drainage tube inlet on the tube wall of the blind end tube far from the connection part of the blind end tube and the root part of the double-pass single-balloon tube A tube; placing the stent tube. Preferably, a section of pipe wall at the root of the double-pass single-balloon pipe B is turned inwards towards the balloon part of the double-pass single-balloon pipe, and then is connected with the blind end pipe in a sealing way, so that the number of the proximal structures of the clamping balloon is reduced.

As shown in fig. 16, in some embodiments, one end of a fixed communicating tube is connected to the clamping balloon, the other end of the fixed communicating tube is connected to the locking device, and the clamping balloon and the fixed communicating tube form a combined balloon tube; the joint balloon tube surrounds the drainage tube from the periphery, the drainage tube longitudinally passes through the joint balloon tube, the isolation piece comprises a section of drainage tube which is surrounded by the joint balloon tube, the drainage tube and the far side of the clamping balloon are connected to a far side connecting point, and the drainage tube and the fixed communicating tube are connected to a near side connecting point; the front part of the drainage tube, which is positioned at the front side of the clamping balloon, is a balloon front section, and the balloon front section comprises a drainage tube inlet and a blind end, and preferably, the blind end is provided with a guide hole.

The first method comprises the steps of making a through-bag through-connection double-tube drainage device shown in fig. 16, sequentially penetrating through a whole double-pass single-bag tube B tube, a bag part and a root part of an A tube at the head end of the blind end tube, and hermetically connecting the root part of the A tube, wherein a drainage tube bag front section is arranged between the root part of the double-pass single-bag tube A tube and the blind end of the blind end tube, a drainage tube inlet is arranged at the bag front section, the locking device is connected and communicated with the near section of the double-pass single-bag tube B tube, and the support tube is arranged inside the blind end tube.

The capsule-penetrating and connecting double-tube drainage device clamping balloon shown in fig. 16 comprises the double-pass single-capsule tube balloon part; the drainage device fixed communicating pipe comprises a double-pass single-bag pipe B pipe, and the cavity of the fixed communicating pipe comprises a gap between the blind end pipe and the double-pass single-bag pipe B pipe; the fixed communicating pipe lumen is communicated with the clamping saccule lumen; the spacer comprises a blind end pipe wall which is jointly surrounded by the clamping saccule and the fixed communicating pipe; the drainage tube includes the blind end tube.

The second method comprises the basic pipeline single-blind single-bag pipe, a locking device and a bracket pipe, wherein the proximal pipe of the single-blind single-bag pipe is set to be a B pipe, and the B pipe is of a tubular structure with a blind end. Firstly, a blind end of a B pipe is sunk to drive a B pipe of the single-blind single-bag pipe of the pipeline to be turned inwards, the blind end of the B pipe passes through a bag part of the single-blind single-bag pipe and a root part of a pipe A of the single-blind single-bag pipe, the B pipe is in sealing sleeve connection with the root part of the pipe A, a front section of a drainage pipe bag is arranged between the blind end of the B pipe of the single-blind single-bag pipe and the root part of the pipe A of the single-blind single-bag pipe, and a hole is arranged at the front section of the bag; the locking device is connected between the single-blind single-bag tube B tube turning line and the single-blind single-bag tube bag part; and (5) placing the stent tube.

The blocking balloon of the through-balloon and through-connection double-tube drainage device shown in fig. 16 comprises a single-blind single-balloon tube balloon portion, the separator comprises a part of a proximal part of a tube wall of the single-blind single-balloon tube after being folded, and the fixed communicating tube lumen comprises a cavity gap between an unfolded part of the single-blind single-balloon tube B tube and a folded part of the single-blind single-balloon tube B tube; the drainage tube comprises a pipeline between the blind end of the single-blind single-bag tube B after being folded and the folding line of the single-blind single-bag tube B; further, a section of external pipeline is communicated at the turning line of the drainage tube, and the external pipeline comprises a basic pipeline straight pipe so as to prolong the length of the drainage tube.

Preferably, the clamping balloon of the penetrating and connecting double-tube drainage device shown in fig. 16 is provided with a shaping strip, a first end of the shaping strip is positioned at a connection point between the distal wall of the clamping balloon and the drainage tube, and a second end of the shaping strip is positioned at a connection point between the clamping balloon and the fixed communicating tube, and preferably, the shaping strip is tubular and made of flexible materials. The manufacturing method of the through-bag and through-connection double-tube drainage device provided with the shaping strip comprises two methods as shown in fig. 17 or fig. 18.

The first method for manufacturing the through-bag continuous double-tube single-bag drainage device shown in fig. 17 comprises the steps of using a double-pass single-bag tube, a blind end tube, a support tube and a locking device, wherein the blind end tube is provided with a continuous bag hole at a section near the open end of the blind end tube, the open end of the blind end tube sequentially penetrates through the B tube, the bag part and the root of the A tube of the double-pass single-bag tube, the blind end tube is in sleeve connection with the root of the A tube and the root of the B tube of the double-pass single-bag tube, the continuous bag hole is positioned between the root of the A tube and the root of the B tube of the double-pass single-bag tube, and the wall of the blind end tube between the root of the A tube and the root of the B tube of the double-pass single-bag tube is a shaping strip; preferably, when the basic pipeline double-pass single-bag pipe B is sheathed and stuck with the blind end pipe, the basic pipeline double-pass single-bag pipe B can be folded inwards towards the bag part of the double-pass single-bag pipe, and then is sheathed and stuck with the blind end pipe, the maximum length of the folded section of the double-pass single-bag pipe B towards the bag part of the double-pass single-bag pipe is not more than half of the circumference of the basic pipeline double-pass single-bag pipe B, and the purpose is to avoid influencing the sheathing and sticking process of the blind end pipe and the double-pass single-bag pipe A, and simultaneously avoid covering the continuous bag hole. Step 2, the blind end of the blind end pipe is recessed into the pipe, the blind end section of the blind end pipe is triggered to fold inwards and penetrate through the shaping strip, the blind end section of the blind end pipe is directly or indirectly sleeved with the double-pass single-bag pipe A, the indirect sleeved with the blind end section of the blind end pipe and the double-pass single-bag pipe A are separated by a part of the opening section of the blind end pipe, the part is already sleeved with the double-pass single-bag pipe A in the previous step, the bag front section comprises a blind end pipe wall structure between the blind end of the blind end pipe and the root of the double-pass single-bag pipe A, and a drainage pipe inlet is arranged at the bag front section. The capsule-penetrating and connecting double-tube drainage device clamping balloon provided with the shaping strip comprises a double-pass single-capsule tube balloon part; the fixed communicating pipe cavity comprises a cavity gap between the folded part of the blind end pipe and the unfolded part of the blind end pipe; the drainage tube comprises a folded rear part of the blind end tube. A locking device is connected to the near section of the outer side wall of the communicating pipe lumen; and 3, placing a support tube inside the drainage tube.

In the embodiment, the drainage tube and the fixed communicating tube are continued at the turnup line, the proximal end of the drainage device manufactured by the method is of a double-layer structure, the movement of the support tube is affected by the double-layer structure outside the double-layer structure, particularly, the movement of the support tube is limited obviously under the condition that the filler is a liquid substance, and in order to improve the operation performance of the movement of the support tube, a section of flexible hose, such as a straight tube, is preferably attached to the proximal end of the inner side wall of the drainage tube to serve as the extension of the drainage tube, and the movement of the support tube inside the drainage tube is easy to control. The dashed line in fig. 17 indicates the adhesive between the two layers or the fusion between the two layers.

The second manufacturing method of the through-bag continuous double-tube single-bag drainage device with the shaping strips as shown in fig. 18 comprises a double-pass single-bag tube, a blind end tube, a straight tube, a support tube and a locking device, wherein in the step 1, a continuous bag hole is formed in one section of the far end of the straight tube, the root parts of the two tubes of the double-pass single-bag tube A, B are sleeved outside the straight tube, the continuous bag hole is positioned between the root parts of the two tubes of the double-pass single-bag tube A, B, preferably, the double-pass single-bag tube B is folded inwards towards the bag part of the double-pass single-bag tube and then is sleeved with the straight tube, and the length of the folded part is smaller than half of the circumference of the straight tube and the double-pass single-bag tube A are prevented from being influenced, and the folded part is prevented from covering the continuous bag hole. The wall of the straight pipe between the root parts of the two-way single-bag pipe A pipe and the two-way single-bag pipe B pipe is a shaping strip; step 2, penetrating the blind end pipe into the inner side of the straight pipe, wherein the blind end section of the blind end pipe is directly or indirectly connected with the double-pass single-bag pipe A pipe in a sleeved mode, the indirect connection means that a section of straight pipe is arranged between the blind end section and the double-pass single-bag pipe A pipe, the section of straight pipe is connected with at least the root of the double-pass single-bag pipe A pipe in the previous manufacturing process, and a drainage pipe inlet is arranged on a far-side tubular structure of the root of the double-pass single-bag pipe A pipe; the proximal end of the straight pipe is in sealing connection with the outer side surface of the pipe wall of the blind end pipe to form annular connection; the clamping balloon comprises the two-way single-balloon tube balloon part; the drainage tube comprises a blind end tube; this fixed communicating pipe lumen includes: the clamping balloon is near to a cavity gap between the straight tube and the blind end tube, and the cavity is communicated with the clamping balloon through a connecting balloon hole; step 3, the locking device is connected or communicated with the proximal end of the fixed communicating pipe; the drainage tube is internally provided with a bracket tube. Preferably, the blind end of the drainage tube is provided with a guide hole.

The two-bag drainage device with the through-bag connected with the double-tube and the double-bag as shown in fig. 19 is preferably based on the method for manufacturing the two-bag drainage device with the through-bag connected with the double-tube and the single-bag as shown in fig. 16, wherein the clamping balloon comprises two balloon bodies and an inter-bag tube communicated with the two clamping balloon bodies, the inter-bag tube has the same material as the fixed communicating tube and the circumference of the tube wall close to the fixed communicating tube, and the double-bag structure in the two-bag drainage device with the through-bag connected with the double-tube has the function of the single-bag structure, and has the spatial advantage in shape, particularly in the aspect of clamping action, such as clamping the drainage tube from two ends of the drainage channel.

The first manufacturing method of the two-way and two-way drainage device shown in fig. 19 uses the two-way and two-way pipe as a whole to replace the two-way and one-way pipe used in the manufacturing process of the two-way and one-way drainage device shown in fig. 16, and particularly uses the two-way structure of the two-way and two-way pipe as a whole to replace the two-way and one-way pipe part; the other manufacturing methods are as the manufacturing method of the through-bag through-connection double-tube single-bag drainage device;

in a second manufacturing method of the through-bag through-connection double-tube double-bag drainage device shown in fig. 19, a single-blind double-bag tube is used as a whole to replace a single-blind single-bag tube in the manufacturing process of the through-bag through-connection double-tube single-bag drainage device shown in fig. 16; especially, the double-bag structure of the single-blind double-bag pipe is taken as a whole to replace the bag part of the single-blind single-bag pipe; the rest manufacturing methods are as shown in fig. 16, and the manufacturing method of the through-bag continuous double-tube single-bag drainage device is as follows;

The third manufacturing method of the through-bag and through-connection double-tube double-bag drainage device shown in fig. 19 comprises the steps of sleeving an additional double-pass single-bag tube outside the wall of the fixed communicating tube between the near side of the saccule of the through-bag and through-connection double-tube single-bag drainage device and the locking device, and arranging holes on the wall of the fixed communicating tube between the root parts of the additional double-pass single-bag tube A tube and the root part of the additional double-pass single-bag tube B tube before sleeving, so as to form the communicating bag holes on the shaping strip.

Further, a shaping strip is arranged on the penetrating and connecting double-tube double-balloon drainage device, the shaping strip is arranged according to the shaping arrangement of the penetrating and connecting double-tube single-balloon drainage device shown in fig. 17 and 18, specifically, a double-pass double-balloon tube is used for integrally replacing the double-pass single-balloon drainage device with the shaping strip shown in fig. 17 and 18, and particularly, the double-balloon structure of the double-pass double-balloon tube is used for replacing the balloon part of the double-pass single-balloon tube, and A, B two tubes on two sides of the double-balloon structure in the double-pass double-balloon tube are used for replacing A, B two tubes on two sides of the balloon part in the double-pass single-balloon tube.

The balloon-penetrating double-tube inner expansion drainage device shown in fig. 20 is developed on the basis of the balloon-penetrating double-tube outer expansion drainage device, and the design concept comprises improvement of the placement position of a stent tube, and in some special cases, the drainage gap space is large, and relatively large clamping balloons or clamping balloons with double-balloon structures, such as the bladder, the stomach, the colon, the rectum, the chest, the abdominal cavity and the like, can be placed. Under these circumstances, can wholly fix the support pipe at drainage tube bag inner section and bag anterior segment, especially including the support pipe be located the inside part of screens sacculus and be the spiral state, wear the drainage tube in linking double-barrelled drainage device through the pulling through the bag, pull into the drainage passageway with the support pipe to reach the effect of expanding the narrow position of drainage passageway.

The front stent tube is arranged on the basis of the through-bag through-connection double-tube external expansion drainage device shown in fig. 16, the stent tube can be reset, the traction auxiliary tube is pulled, and the front stent tube comprises: the whole stent tube is fixed with the head of the drainage tube, and can also be understood that the whole stent tube is a part of the head of the drainage tube, the drainage inlets of the two are communicated, the proximal end of the stent tube is positioned in the clamping balloon in a non-drainage state, and the part of the stent tube positioned in the clamping balloon is named as the inner section of the stent tube balloon; the stent tube resettable arrangement comprises: the elastic capsule wall of the clamping saccule a, the filling material of the clamping saccule b comprises air, the inner section of the stent tube is in an elastic bending state, and particularly comprises a spiral state, the flexible filling material storage saccule d and the combination of at least two modes; the traction auxiliary tube is attached to the traction point at the inner side of the isolation piece and is in sealing connection with the wall of the isolation piece, the traction point is provided with a distance at the proximal end of the lumen of the fixed communicating tube in the device in a non-drainage state, the turnover and folding function of the wall of the isolation piece (namely the wall of the drainage tube) on the distance provides the mobility of the head of the drainage tube at the distal side of the traction point of the drainage tube, when the traction auxiliary tube is used for traction of the wall of the isolation piece, the head of the drainage tube and a support tube (or a rigid drainage tube head combining the two) in the head of the drainage tube are pulled into a drainage channel and the narrow part of the drainage channel is expanded, and the drainage process is realized. The filler reservoir in this embodiment has the effect of temporarily storing the filler.

The manufacturing method of the through-bag through-connection double-tube internal expansion drainage device as shown in 20 comprises the steps of fixing a section of support tube with a spiral structure to the drainage tube head section on the basis of the through-bag through-connection double-tube drainage device as shown in fig. 16, connecting a traction auxiliary tube to the inner side tube wall of a separator of the through-bag through-connection double-tube drainage device, and further arranging a filler storage bag at the outer section of a communicating tube, wherein the filler storage bag is connected with a locking device or the filler storage bag is provided with a locking device; preferably, the filler in the drainage device comprises air; more preferably, the drainage device-retaining balloon wall is an elastic balloon wall.

The placement of the through-the-balloon and through-connection double-tube internal expansion drainage device, the mobile stent of which is prepositioned, as shown in fig. 20, the method for placing the drainage device comprises the following steps: a, directly inserting the front section of the drainage device into a drainage channel, under the condition that the drainage channel is relatively short, enabling the clamping balloon part to enter a drainage gap, inputting clamping balloon filler into a communicating pipe through a locking device, enabling the clamping balloon to enter the drainage gap to be partially expanded, and pulling the whole clamping balloon into the drainage gap. b, using a pushing tube, selecting a pushing tube with the circumference smaller than the circumference of the lumen of the stent tube or a common clinically used sputum suction tube, a catheter and the like to be inserted into the front end of the interior of the front stent tube, pushing the front stent tube and the clamping balloon into a drainage gap, inputting the clamping balloon filler, and withdrawing the pushing tube or other pushing pipelines. C, selecting a conveying catheter with the circumference of the lumen of the conveying catheter being larger than the circumference of the front structure of the drainage device, conveying the clamping saccule of the drainage catheter to a drainage gap, and pushing the inner structure of the conveying catheter towards the drainage gap by using a pushing tube; the clamping saccule is filled with clamping saccule filling materials after entering the drainage gap, and the pushing pipe and the conveying catheter are withdrawn; preferably, a guide hole is arranged at the blind end of the drainage tube, a guide wire is led to pass through the guide hole, and the drainage device is pushed into the drainage gap along the guide wire by the pushing tube.

After the placement, the traction auxiliary tube of the drainage device is pulled outwards, and the proximal end of the front stent tube is pulled into the drainage channel and drainage is realized through the narrow part of the drainage channel due to the movable arrangement, as shown in fig. 20. When the pulling auxiliary pipe is pulled, the action mechanisms of the movable arrangement include: a, expanding the wall of the elastic clamping balloon and axially compressing the clamping balloon; b, compressing the elastic filler to cause the clamping balloon to be axially compressed; c, stretching the elastic spiral stent tube; d, the filler is transferred to the filler storage bag to cause the clamping balloon to axially compress, and the four mechanisms can be independently arranged or simultaneously arranged. The axial direction of the clamping balloon generally refers to the pulling direction of a drainage tube connected with the clamping balloon.

The drainage is finished, the traction auxiliary tube is loosened, the tail end of the support tube is retracted into the clamping balloon under the reverse action mechanism of the movable arrangement, and the process can be implemented or accelerated by extruding the filling material storage bag. Preferably, the surface of the spiral drainage tube of the drainage tube inner section is provided with longitudinal grooves which facilitate the movement of the filler.

The method for taking out the through-bag connecting double-tube inner expanding drainage device shown in fig. 20 comprises the following steps: a, opening a locking device or breaking the sealing performance of the fixed communicating pipe in vitro to release the clamping balloon filler, and taking out the drainage device; b, using a breaking sleeve or a breaking cutter to break the integrity of the clamping balloon, thereby taking out the drainage device.

Stomach tube

The conventional nasal feeding tube is mainly applied to the following cases, in which a swallowing action cannot be completed autonomously due to injury or hypofunction of a innervation system responsible for the swallowing activity, and a certain section of the upper digestive tract is not suitable to be subjected to food stimulation such as after an esophageal operation. The stimulation of the digestive tract above the ligament of the flexor by food during the onset of pancreatitis causes the exacerbation of pancreatic inflammation, and the food is required to be conveyed to specific positions of the digestive tract, such as the stomach, the duodenum and the jejunum through a pipeline. The relationship between the clamping balloon and the drainage tube of the nasal feeding tube can be exemplified by a top balloon, a penetrating balloon and a capsule, the capsule wall of the clamping balloon comprises an elastic capsule wall and a non-elastic capsule wall, preferably, the nasal feeding tube clamping balloon filler comprises a combination of different components of water, paraffin oil and silicone oil to adjust the fluidity or specific gravity of the filler, and particularly comprises a high-concentration sodium chloride aqueous solution, the specific gravity of the high-concentration sodium chloride is higher than that of the water, the adjustment of the specific gravity of the clamping balloon is beneficial, the position of the clamping balloon which is far away from an oral cavity is induced by adjusting the body position, and in addition, the filling ratio of the nasal feeding tube clamping balloon is further adjusted to enable the clamping balloon to be physically closer to a group of primarily digested foods, preferably, the communicating tube in the nasal feeding tube embodiment selects a movable communicating tube, and further, the movable communicating tube and the support tube are arranged in series inside the drainage tube, and particularly comprises the communicating tube and the support tube which are integrally formed. After the drainage tube is placed in the stomach, filling materials are input into the clamping saccule through the communicating pipe or the communicating pipe and the bracket pipe which are connected in series; the mobile communicating tube is pulled out, the nasal feeding tube is in a standby state, and preferably the tail end of the nasal feeding tube is provided with a plug or a clip. In addition, the nasal feeding tube comprises a fixed communicating tube, the length of the fixed communicating tube at least comprises 400mm to 650mm, the fixed communicating tube can run outside the drainage tube and parallel to the drainage tube, the fixed communicating tube can also run inside the drainage tube, the drainage tube is penetrated out in the scale range of 400mm to 650mm, the fixed communicating tube with the length of 400mm to 650mm can only ensure that the clamping balloon enters the stomach part, after proper filler is input into the clamping balloon, the tail end of the fixed communicating tube is sealed, and the sealing mode comprises the use of an adhesive, welding or the arrangement of a sealing block at the tail end of the fixed communicating tube; the amount of the inserted blocking balloon filler is usually less than 100ml, and a non-elastic blocking balloon is preferably used; the nasogastric tube was placed in the stomach and the stent tube was pulled out. Further, if a nasogastric tube is required to enter the duodenum or jejunum, a certain margin length is required to be given to the drainage device, peristaltic motion of the gastrointestinal tract causes movement of the clamping balloon portion, and meanwhile, the proximal end of the fixed communicating tube can be brought into the upper digestive tract, such as the esophagus or stomach, so that under the condition, only a flexible drainage tube structure passes through the structure of the throat and nasal cavity.

Preferably, the maximum cross-section circumference of the retention balloon of the nasogastric tube comprises 30mm to 45mm, preferably the retention balloon comprises an approximately cylindrical shape, the circumference of the cylinder comprises 15mm to 45mm, and the long axis of the cylinder is parallel to the axial direction of the drainage tube. The clamping function of the clamping balloon of the nasal feeding tube is mostly based on the gravity and gastrointestinal peristalsis function, and most of the clamping balloon can be pulled out through the nasal cavity in the filling state under the condition of using the inelastic clamping balloon and low filling ratio. The main purpose of limiting the circumference of the cross section of the clamping saccule is to avoid the damage of the excessive clamping saccule to the esophagus when the nasal feeding tube is pulled out of the esophagus accidentally.

In embodiments using a mobile communication tube, a breaker tool or a breaker sleeve may be used to break the integrity of the cartridge. In the case of using a demolition tool, another stand-by stent tube may be used, or the stent tube pulled out in the insertion operation may be left and sterilized for use. In embodiments using a fixed communication tube, the locking device connected to the fixed communication tube may be opened to release the cartridge; in special cases, if the length of the drainage device of the nasal feeding tube which is placed in the body is longer than that of the fixed communicating tube, the nasal feeding tube needs to be pulled outwards until the tail end of the fixed communicating tube is pulled out of the nostril, and then the clamping saccule filling material can not be released. Although the circumference of the cross section of the clamping balloon is limited, the clamping balloon can be pulled out of the esophagus together with the filling material of the clamping balloon, in order to avoid the esophagus damage, the drainage device is withdrawn safely after the filling material in the clamping balloon is released as much as possible.

Because the bracket tube of the drainage device is moved out of the drainage tube after the nasal feeding tube is placed at the corresponding position, the conveying capacity and the comfort level of the nasal feeding tube are obviously improved.

The total length of the nasal feeding tube drainage tube can be set to be 700mm to 2500mm, the length of the drainage tube in the drainage device simply placed in the stomach can be set to be 700mm to 1200mm, the length of the nasal feeding tube used for perfusion of the duodenum and jejunum part can be set to be 1200mm to 2500mm, a conveying catheter can be used when the nasal feeding tube drainage tube is placed, the length of the conveying catheter can be smaller than the length of the drainage tube, the length of the conveying catheter can be set to be 500mm to 650mm, the drainage device can only be placed in the stomach under the length, and the device can reach the duodenum and jejunum and relies on peristalsis of the gastrointestinal tract; because of the traction and compression of the adjacent tissues and blood vessels and ligaments of the section of the digestive tract from the stomach to the duodenum and even jejunum, the section of the digestive tract is too tortuous, and the placement procedure of a general rigid tube is difficult to complete without endoscopic or radiological guidance. From the stomach to the duodenum and the more distant digestive tract parts, the flexible drainage tube head and the low filling ratio clamping balloon are pushed to the parts needing to be reached under the peristaltic motion of the gastrointestinal tract. Preferably, one stent tube is additionally arranged in the drainage devices and is independently packaged in a sterile way, and when the drainage devices are needed to be used, the drainage devices are directly placed into the stent tube to finish drainage work. Preferably, the clamping balloon is selected as an inelastic clamping balloon, the shape of the inelastic clamping balloon changes along with the quantity of the fillers, the filling ratio of the clamping balloon is that the volume of the fillers accounts for the maximum filling volume percentage of the clamping balloon, the flexible clamping balloon has certain expansibility, the internal pressure of the clamping balloon increases along with the increase of the quantity of the fillers of the clamping balloon, the volume of the clamping balloon also increases along with the increase of the quantity of the fillers of the clamping balloon until the clamping balloon breaks, and the volume of the clamping balloon before the breaking is the maximum filling volume of the clamping balloon. In the embodiment, the filling ratio of the clamping balloon is 10-85% of the optimal value, and under the condition of small filling amount, the characteristics of the clamping balloon are more similar to that of a bolus of liquid which changes along with the change of the external shape, so that the clamping balloon can more easily pass through the pylorus and the duodenum and further pass through the ligament of dropsy to reach the jejunum.

In general, the restriction of the circumference of the drainage tube by the esophagus, stomach, duodenum, jejunum is relatively small, and the preferable value of the circumference of the drainage tube in a nasogastric tube for upper digestive tract use includes 15mm to 45mm. The flexible tube section of the nasal feeding tube is mainly suitable for the oropharynx, the nasopharynx and the nasal cavity, and excessive flexible tubes can be accumulated in the oral cavity to block the respiratory tract and cause uncomfortable feeling. The preferable scheme is that the length of the flexible tube section of the nasal feeding tube which is not supported by the bracket tube is limited to 200mm to 400mm; to achieve this objective, a stent tube needs to be placed in the inner section and the outer section of the drainage tube respectively to limit the length of the simple flexible tube section in the nasal feeding tube; preferably, the outer section of stent tube end is connected to the drainage tube end.

Further, in some embodiments of the nasal feeding tube, a pulling device is provided, wherein the pulling device is mainly used for pulling the clamping balloon in the nasal feeding tube to the cardiac position through pulling the outer part of the nasal feeding tube, the pulled clamping balloon is sealed relatively to the cardiac opening, so that the gastric content can be blocked from flowing back to the esophagus or the food can be reduced from flowing back to the esophagus, the pulling device comprises a hanging weight, the hanging weight continuously pulls the nasal feeding tube at the position where the nasal feeding tube exits from the nostril, the weight of the weight is greater than the weight of the inner part of the nasal feeding tube, the weight comprises a metal ring, a metal block, or a ceramic ring or block, and the weight of the weight comprises 1g to 100g; the traction device also comprises a binding belt which can be elastically deformed after being pulled, one end of the binding belt is connected with the nasal feeding tube wall, and the other end of the binding belt is hung on the protruding parts such as the neck, the head, the ears and the like. Preferably, the nasal feeding tube clamping balloon filler comprises air, and the air is light in weight and is beneficial to reducing the force of traction fixation; the nasal feeding tube comprises a drainage device with a through-bag or side-bag structure, a drainage material inlet is not arranged on a drainage tube at the proximal side of the clamping balloon in the embodiment, preferably, the nasal feeding tube is provided with a support tube inner section and an outer section, the support tube inner section is arranged at the proximal side of the clamping balloon, the support tube outer section is arranged at the outer section of the drainage tube, and the drainage tube is in a simple flexible structure at the oropharynx, the nasopharynx and the nasal cavity; the structure can maintain the hardness of the inner section and the outer section of the nasal feeding tube body to avoid blocking the airway, and preferably, the clamping balloon adopts a proximal shaping clamping balloon to reduce the damage to the cardiac part.

Some patients with digestive tract obstruction often lose the way of supporting nutrition through the digestive tract, so that complex and higher-risk intravenous nutrition has to be performed, and the embodiment can solve the difficult problem of supporting nutrition through the digestive tract under the condition of partial digestive tract obstruction, and the main design concept is to intermittently attract substances above the digestive tract obstruction part, wherein the substances above the digestive tract obstruction part comprise undigested food, sloughed digestive tract cell tissues and redundant gas and liquid, and with the excretory system, an individual with the digestive tract obstruction can take food through the mouth or through the stomach or jejunum fistulization mouth, and the preferred food comprises low-slag food or element diet. The closer the obstruction is to the anus, the longer the alimentary canal is, the better the effect. According to the embodiment, the drainage device is placed into the nasal cavity, oral feeding is affected less, preferably, the drainage tube is provided with the drainage tube inlet at the upper section of the menstrual jejunum, the section of the duodenum and the section of the stomach, local gas or liquid can be sucked at fixed points through the head end opening of the external support tube section, liquid food can be put in, and the effect of food put in different positions on the digestive tract is of different significance. The main function of the clamping saccule in the embodiment is to drive the whole drainage system to advance along with the peristaltic motion of the digestive tract under a lower filling ratio. The clamping function is mainly to utilize the traction force of forward peristalsis of the digestive tract and the gravity traction function of the forward peristalsis of the digestive tract on the position of the prolapse of the digestive tract. The filling material of the clamping balloon in the embodiment comprises water or sodium chloride water solution, the filling ratio comprises 10-80%, and the preferable clamping balloon wall is an inelastic clamping balloon. In the embodiment, the length of the fixed communicating pipe or the movable communicating pipe is not required to be larger than that of the inner section of the drainage tube, and after the head end of the drainage device is placed in the stomach and confirmed, the filling material can be injected into the clamping saccule, and the movable communicating pipe is pulled out, or the filling material is input through the locking device; for the convenience of placement, fixed communicating pipe or portable communicating pipe can walk to 400mm to 650mm scale department at the drainage tube outside or inside with the drainage tube, walk to wear out the drainage tube from 400mm to 650mm department at the inside communicating pipe of drainage tube in this case, and the hole of leaving behind on the drainage tube after pulling out portable communicating pipe can be sealed or not, and the locking device with fixed communicating pipe adaptation preferably includes sealing block or adhesive.

The clamping sacculus distal section and/or the proximal section of the drainage tube are/is provided with a drainage object intersecting hole, intestinal juice at the position where the drainage object intersecting hole is located is more easily sucked out of the body, gas or liquid above the obstruction position can reach the nearby drainage object intersecting hole through the movement of the drainage object intersecting hole in theory, and the gas or liquid near the drainage object intersecting hole can be covered and sealed by the attached intestinal wall after the suction is finished; specifically, the length of the drainage tube comprises 1500mm to 6000mm, and the length of the external part is 600 to 800mm; the total length of the stent tube comprises 1300mm to 5400mm, the stent tube is divided into two parts, one part of the stent tube is positioned in a body, the other part of the stent tube is positioned outside the body, the length of the outside body is 500 to 700mm, the digestive tract obstruction parts are different, the lengths of the adopted drainage tube and the stent tube are also different, preferably, the proximal drainage tube at the proximal oral cavity end of the inner section of the stent tube body of the drainage device is made of a flexible film material which is airtight, and the negative pressure of the drainage tube is favorably maintained. The preferred values for the circumference of the inner section of the drain tube include 15mm to 30mm.

For example, when ileum is obstructed, according to relevant professional judgment, the drainage tube needs to be placed in the alimentary canal with the distance from the nostril of about 4000mm, a drainage device with the total length of the drainage tube of 4800mm is selected, the length of the inner section of the drainage tube of 4000mm, the length of the outer section of the drainage tube of 800mm is not strictly distinguished from the inner section of the drainage tube, preferably, the circumference of the outer section of the drainage tube is longer than that of the inner section of the drainage tube, the circumference of the outer section of the drainage tube is increased and is easier to fold, and the ratio of the circumference of the outer section to the circumference of the inner section of the drainage tube is 1-5; the length of the inner part of the support tube body is 3600mm, the length of the outer section of the support tube body is 800mm, the difference between the length of the drainage tube and the total length of the two support tubes is the length of the soft section of the drainage device, the length of the soft section is 400mm, the position of the soft section is changed along with the different placement depths of the drainage device, the length of the inner part is preferentially considered when the drainage device is designed, the length of the inner part floats when in use, the principle is that the distance between the proximal end of the inner section of the rigid support tube body and the pharyngeal part is more than 100mm, preferably more than 200mm, and the probability of the pharyngeal part being stimulated by the rigid tube is reduced to a lower level.

Preferably, the outer diameter of the outer section of the stent tube is smaller than that of the inner section of the stent tube, and the main purpose is that the circumference of the outer section of the stent tube is thinner, so that the stimulation to the oropharynx, the nasopharynx and the nasal cavity can be reduced; preferably, the inner section of the support tube body is fixed with the front section of the drainage tube, or the inner section of the support tube body and the front section of the drainage tube are combined into a rigid tubular structure, the rigid tubular structure acts as the support tube and the drainage tube, the rigid tubular structure is provided with holes, the shapes of the holes which can be enumerated comprise rectangle, ellipse and gap, the circumference of the edge of the hole preferably comprises 6mm to 30mm, and the number of the holes of the rigid tubular structure per 100mm length is 1 to 50; the distribution range of the drainage material inlets on the drainage tube is within the range of 50mm to 3500mm of the scale of the drainage device. The front end of the outer section of the support tube body comprises an axial opening, and the tail end of the outer section of the support tube body is in sealing joint with the tail end of the drainage tube.

The method for placing the drainage device into the stomach is like other traditional gastric tubes or three-cavity two-bag tube placing methods, the head end of the drainage device is conveyed to the stomach, at the moment, filling materials are injected into the clamping saccule, the clamping saccule is sealed or the mobile communicating tube is pulled out, the clamping saccule enters the small intestine along with gastrointestinal peristalsis, the head end position of the drainage tube is calculated according to the length of the external part of the drainage tube, and the head end of the drainage device reaches 4000mm away from nostrils. In the process, the body position is changed, the external support tube is butted with the internal support tube, and then intestinal contents are repeatedly sucked or a small amount of liquid is injected, so that the support tube is pushed forwards, and the like, thereby being beneficial to the forward movement of the drainage tube; after the implantation is finished, the outer section of the stent tube body is retracted to the outer part of the drainage tube, at the moment, the drainage tube from the upper section of the esophagus to the nostril is a flexible tube wall, and the local comfort level is good; the external section of the drainage tube is fixed. The drainage device is easier to put through a stomach fistulization opening or a jejunostomy opening.

After oral feeding, the fluid food passes through stomach, duodenum, jejunum and reaches ileus obstruction. In the process, most nutrient substances are absorbed, a small amount of unabsorbed food, intestinal juice and gas are gradually accumulated in the intestinal tract, at the moment, the outer section of the stent tube is pushed forward to be in butt joint with the stent tube in the body, a negative pressure aspirator is started or a negative pressure source is connected, the negative pressure value comprises-600 mmHg to-100 mmHg, after the gas or liquid in the intestinal tract is sucked out, the outer part of the stent tube is withdrawn to the outer part of the drainage tube, and the drainage process is finished.

The normal start-up procedure of gastric lavage is urgent, the operation needs to use negative pressure to promote the rapid outflow of gastric contents, in addition, the negative pressure is beneficial to the outflow of larger blocks from the drainage tube, one difficulty in the gastric lavage procedure is that the negative pressure attracts the particles in the drainage tube drainage material to block the inlet of the traditional gastric lavage tube placed in the stomach, the normal practice comprises that a certain amount of gastric lavage liquid is input into the stomach again to temporarily wash out the blocking material, in this case, the gastric lavage procedure is prolonged, and the pain of patients is increased. The movement of the stent tube in the head of the drainage tube in the present invention can push away particles in the drainage material blocking the inlet of the drainage tube, in these embodiments, the tail end of the stent tube is sealingly connected to the tail end of the drainage tube. Preferably the drain tube has a perimeter value of 20mm to 60mm, the perimeter being selected to take into account the size of the stomach food particles. The length of the drainage tube of the drainage device is 1000-1400 mm, and the length of the stent tube is 800-1000 mm. Preferably, this embodiment has two stent tubes, one of smaller circumference for use when starting gastric lavage to place the drainage device in the stomach, and in order to avoid the small circumference of the stent tube penetrating the holes of the drainage tube hole section, the edge circumference of the hole in the area of 100mm near the blind end of the drainage tube in this embodiment is smaller than the circumference of the thin stent tube, and if necessary replaced by another stent tube of larger circumference. Preferably, the gastric lavage of critical patients is needed repeatedly under the condition of gastric lavage or the gastric tube needs to be left for a period of time, at the moment, the stent tube can be moved out of the body and fixed at the outer part of the drainage tube, and the stent tube is placed into the drainage tube when needed; preferably, the stent tube with the thicker tube diameter is divided into an inner section and an outer section.

A drainage tube which is placed through a narrow part of an alimentary canal through anus, enables the clamping balloon to be placed on the side of the narrow part of the alimentary canal near the oral cavity, solves the problem of partial blockage of the alimentary canal, particularly solves the problem of obstruction caused by tumor of small intestine, colon or rectum and intestinal obstruction caused by postoperative intestinal adhesion, the clamping balloon is sent to the side of the narrow part near the oral cavity, operation is often needed, the feasibility of the open operation is very small, the clamping balloon is simply placed into the side of the narrow part near the oral cavity, the cause of obstruction is not completely removed when the obstruction removing operation is carried out, or a long period of time is needed after the operation to remove the obstruction, a drainage device is placed from the anus under the help of an operator in the operation process, and the clamping balloon is sent to the side of the narrow part near the oral cavity. For intestinal obstruction caused by tumor, the embodiment is provided with a longer rigid drainage tube penetrating through the front section and the rear section of the clamping balloon, the section of the rigid tubular structure can be understood as a structure with the drainage tube and the stent tube being combined into a whole in design concept, the length of the rigid section of the preferable clamping balloon in front and at the rear comprises 500mm to 1000mm, the circumference of the rigid tubular structure of the drainage device penetrating through the clamping balloon comprises 25mm to 40mm, the tube wall of the drainage device is provided with holes, the circumference of the holes comprises 10mm to 50mm, and the number of the holes arranged in the rigid tubular structure of the drainage tube with the length of 100mm comprises 1 to 5; the circumference of the flexible drainage tube in the drainage device comprises 20mm to 60mm, holes are formed in the tube wall, the circumference of the holes comprises 10mm to 20mm, and the number of the holes in the flexible tube wall of the drainage tube with the length of 100mm comprises 1 to 5; the length of the flexible drain tube segment comprises 1000 to 2000mm. In the embodiment, the irritation of the flexible drainage tube wall to anus and perianal skin is reduced, the outer section of the support tube body stays at the outer part of the drainage tube body in a non-drainage state or is withdrawn temporarily, food which is drained to the side of the obstruction part near the anus can stimulate the intestinal tract to play a role in the position, the integrity of the digestive tract is kept, the normal defecation is not influenced by the flexible tube wall at the anus opening, and the excrement storage function of the colon and the rectum is reserved.

A drainage tube for constipation is disclosed, which is mainly characterized by that a large quantity of excrement is accumulated in rectum or sigmoid colon, and the internal space of rectum and sigmoid colon is expanded by excrement, so that its own active contractility is lost, and the tension of anal sphincter is raised, so that the difficulty level of defecation is raised. In the embodiment, a bag-penetrating design is adopted, the front section of the bag comprises a rigid pipe section, the length of the rigid pipe section preferably comprises 100mm to 500mm, and in a non-drainage state, the support pipe is positioned in the drainage tube outside the anus; the front end of the balloon front section is a blind end, the perimeter of the balloon front section drainage tube comprises 20mm to 90mm, the balloon front section is provided with a hole, the shape of the hole comprises a circle, an ellipse, a rectangle and a gap, the perimeter of the edge of the hole is preferably 20mm to 100mm, and because the clamping balloon is close to the body surface, no special requirement exists for the form of the filling and discharging accessory. The rear section and the section of the drainage tube are non-porous flexible tube walls, wherein the circumference of a part of the rear section of the drainage tube, which walks in the anus, is close to the circumference of the inner section of the drainage tube, the difference value of the circumference is not more than 50% of Duan Zhouchang% of the circumference of the inner section of the drainage tube, and the drainage tube passing through the anus is a flexible tube; due to the functional instability of the digestive tract, in the case of rectal burst defecation, the extracorporeal drainage tube needs to have space compensation capability, and the perimeter design thereof considers the case of abrupt large-volume gas or liquid gushes. The preferred values of the circumference of the outer section include 30mm to 90mm, preferably the stent tube tail end outlet is sealingly connected to the drain tube tail end outlet to form a common orifice structure, and the length of the drain tube outer section of the drainage device includes about 300mm to 1000mm, which is mainly for convenience of operation, and the length of the stent tube outer section is less than 50mm to 100mm of the length of the drain tube outer section. When the drainage device is used, the outer section of the stent tube body is inserted into the anus along the flexible drainage tube and is contacted with the inner section of the stent tube body, the negative pressure aspirator is started, and the excrement remained in the inner section of the stent tube body is sucked into the inner section of the stent tube body. In order to facilitate softening of hard feces in the rectum, physiological saline, paraffin oil, soapy water and other liquids can be input into the rectum through the external section of the drainage tube, the liquid for softening the feces is repeatedly input and repeatedly sucked, and the operation of the intestinal tract is recovered along with the removal of the feces. The anterior segment of the drainage tube bag has the functions that: the fecal in the intestines is transferred to the anterior segment of the drainage tube bag under the negative pressure, and the intestinal wall is not damaged by the traction and pushing of the outer segment of the inserted stent tube due to the blocking effect of the drainage tube wall. Preferably, the negative pressure is intermittently activated, the negative pressure value preferably being-300 mmHg to-100 mmHg.

Further, this embodiment is equally applicable to the case of an artificial anus, since the artificial anus does not have an anal sphincter, a trans-capsular trans-double tube drainage device is preferably used. The process of inserting the outer section of the stent tube into the anterior section of the balloon is beneficial to the expansion of the contracture stoma due to progressive contracture of the abdominal wall stoma.

Urinary catheters are used where urine cannot be removed from the body or is not removed from the body on demand, such as recording urine volume per hour. The invention is characterized in that under the non-drainage state, the effect on the inherent temporary urine storage function of the bladder is small, the irritation to the prostatic and urethral sphincter meats and urethral mucosa is small, the stent tube passes through the urethra and enters the bladder, and the urine is led out; the external expansion drainage device particularly comprises a capsule penetrating structure, particularly comprises a clamping balloon proximal shaping design, and when the drainage tube is pulled, the urethral orifice in the bladder is anastomosed with the concave part of the proximal shaping clamping balloon, so that local extrusion stimulation is avoided. Under the general condition, the clamping saccule near-side drainage tube is arranged as a complete drainage-free object intersecting hole, so that urine is guaranteed to be completely guided out after being collected.

Urinary retention caused by bladder function runaway comprises nerve cause, detrusor muscle weakness, urethra and bladder neck muscle tension contracture or structural stenosis, especially comprises prostatic hyperplasia, inflammation, tumor and other causes, and chronic bladder injury is hard to recover due to long-term urinary retention. Preferably, a single tube drainage device with a proximal shaped retention balloon arrangement is used in this embodiment, the preferred values of the peripheral circumference of the drainage tube in this embodiment comprise 10mm to 40mm, more preferably 15mm to 30mm; the front section of the head sac of the drainage tube is provided with a hole, the front end of the front section is a blind end, preferably, the front section of the head sac of the drainage tube is of a rigid tubular structure, and the length of the rigid tubular structure preferably comprises 10mm to 30mm; because of the low coefficient of viscosity of urine, negative pressure is not typically required to promote urine flow. Preferably, holes are arranged on the section of the drainage tube passing through the prostate or the section of the drainage tube is a woven tube or a woven tube with a net shape, and the purposes of the two are that the total volume of the partial drainage tube per unit length is reduced, that is to say, the total mass of the section of the drainage tube is reduced along with the increase of the number of the holes, the increase of the perimeter of a single hole and the decrease of the minimum distance between adjacent holes, the section of the drainage tube passing through the prostate has better flexibility and smaller local irritation to the prostate; the drainage tube is provided with holes through the prostate segment, which is favorable for the exchange of urine and prostate part secretion, and has cleaning function. Another advantage of this type of embodiment is that it has bladder function recovery promoting effect, conventional bladder function exercise relies on manual gripping and timed opening of conventional catheters, and after conventional catheter placement, professionals determine that autonomous urination is possible, pull out the catheter, and if urination is still not possible, the catheter needs to be placed again. The clamping of the drainage tube in this embodiment relies on the natural tension of the prostate and the urethral sphincter, and the distortion of the prostatic urethra and the increase of the pathological tension in the prostatic urethra under pathological conditions, and after the bladder function is restored or the prostatic hyperplasia edema is relieved, the prostatic urethra gradually relaxes, so that the patient can subjectively try to urinate by himself, along with the contraction of the detrusor muscle and the relaxation of the urethral sphincter, urine can enter the inlet of the drainage tube, further flows out of the prostatic urethra and the external sphincter, and flows out of the urethra along the lumen enclosed by the drainage tube, the stent tube and the urethral wall together. Preferably, the range of the hole section of the rear section of the clamping balloon is limited to be within 100mm from the near side of the clamping balloon, so that urine stored in the drainage tube is prevented from overflowing to the outside of the drainage tube. Preferably, the front end of the support tube is a rounded blind end, and a guide hole with the circumference of 3mm to 6mm is arranged in the center of the blind end, so that the guide wire penetrates through the guide hole, and the blind end is pushed by the support tube along the guide wire to drive the clamping balloon to enter the bladder along the guide wire. Preferably the drainage device balloon anterior segment length comprises 5mm to 20mm, preferably the drainage device drain tube length comprises 200mm to 550mm; preferably, the drainage device clamping balloon is provided with a shaping strip.

The catheter adopting the through-bag through-connection double-tube internal expansion drainage device has the preferable peripheral circumference of the communicating tube comprising 10mm to 40mm, more preferably 20m to 30mm, the front section tube wall of the device is provided with a hole, the blind end center is provided with a guide hole, and the catheter adopts one or more of the following settings: the elastic clamping saccule, the elastic bending support pipe saccule inner section is arranged, and the filler storage saccule and the filler comprise air; in particular, the inner section of the stent tube which comprises elastic spiral bending is provided, and the length of the stretched stent tube preferably comprises 40mm to 100mm; preferably, the drainage device is provided with a traction auxiliary pipe, the traction auxiliary pipe is simple in traction process, the traction auxiliary pipe can be completed by one hand, and the sealing performance between the pipe wall of the communicating pipe and the inner side wall of the urethra is good. Preferably, the traction auxiliary tube is provided with a clip or a plug, so that the traction auxiliary tube is conveniently closed temporarily, particularly the external part of the traction auxiliary tube outside the urethra can be set shorter, preferably, the length value of the drainage tube comprises 200mm to 500mm, more convenient to transfer, preferably, the clamping balloon of the through-balloon penetrating and connecting double-tube drainage device is provided with a shaping strip, and the shaping strip is provided with a connecting bag hole.

The invisible internal expansion catheter with the magnet comprises a through-bag through-connection double-tube internal expansion drainage device, wherein a sealing block is adopted by the locking device of the catheter, the locking device of a fixed communicating pipe is positioned at a position close to an external orifice of a urethra in the embodiment, the circumference of the fixed communicating pipe comprises 20mm to 30mm, the initial position of a traction auxiliary tube is positioned at the position close to a clamping balloon and is 40mm to 50mm, the traction auxiliary tube is connected with a clamping short tube, the clamping short tube is of a rigid tubular structure, the optimal value of the circumference of the tubular structure comprises 35mm to 45mm, and the tubular rigid structure of the circumference is difficult to enter the prostatic part of the urethra, so that the automatic sliding of the drainage device into the bladder is avoided, and the drainage device is disabled; the device is provided with an elastic spiral bent stent tube inner section, and the tail end of the clamping short tube is positioned in the urethra cavernous body under the non-drainage state. When urine is required to be drained, the clamping short tube is pulled outwards slowly at the outer side of the skin of the penis, the built-in support tube is pulled into the prostatic part of the urethra due to the stretchable performance of the penis, the urethra with the narrow prostatic part is expanded, and the urine starts to drain; and after the drainage is finished, loosening the traction short pipe, and rebounding the bracket pipe into a drainage gap, so that the drainage process is finished. Preferably, the detent nipple comprises an iron-containing structure with soft magnetic properties, which is capable of being attracted by a magnet outside the skin of the penis to drive the pulling sub-tube towards the external orifice of the penis, preferably using an electromagnet, in particular an electromagnetic coil capable of being nested in the penis, in particular an electromagnetic coil capable of varying the magnetic field strength by controlling the current strength and frequency.

The body cavity drainage tube has the advantages that the surface of the drainage device is shallow, the device and the method provided by the invention are mainly used for rescuing treatment or invasive treatment, and the part of the drainage device penetrating out of the skin is a flexible tube in a non-drainage state, so that the comfort level is high; secondly, the stent tube is repeatedly placed into the body cavity section drainage tube, which is beneficial to maintaining the local patency; in the preferred through-bag drainage device in this type of embodiment, the inner section of the drainage tube bag comprises a flexible tube wall, the relation between the drainage tube and the clamping balloon and the relation between the drainage tube and the communicating tube are not particularly required, in order to achieve the sealing effect, the wall of the drainage tube near the clamping balloon is arranged in a non-porous way, the drainage tube at the front section of the bag is provided with a hole, preferably, the drainage device is provided with a clamping balloon of a double-balloon string, and the near-side balloon of the double-balloon string is positioned on the body surface and has a fixing effect.

The utility model provides a chest drainage device, for the flow demand of blood pneumothorax drainage, the periphery girth preferred value of drainage tube includes 20mm to 45mm in this class embodiment, preferably, this chest drainage device includes wears the bag and wears to link double-barrelled drainage device, the outside pipe wall girth preferred value of fixed communicating pipe includes 20mm to 45mm, under the circumstances that needs to last drainage, support pipe is from external along drainage tube pipe wall pass chest wall and this drainage tube head coincidence, hole Duan Chongdie on the two head sections, the hole section length preferred value of two is 50mm to 100mm, the shape of two Kong Duankong includes rectangle, ellipse, gap etc. the edge girth preferred value of hole is 0.5 to 0.8 times of device support pipe girth, adjacent hole shortest distance is less than 50mm, this fixed communicating pipe is closely contacted with chest wall tissue under the filling pressure effect of screens sacculus filler, sealing performance is good. Additionally, the anterior segment of the chest drainage device balloon comprises a rigid tube, and the drainage speed of the rigid tube is higher.

The utility model provides an abdominal cavity drainage device, abdominal cavity liquid drainage and medicine input are lower than the requirement to thorax position drainage thing drainage speed to the speed, and long-term catheterization is mainly for purposes such as peritoneal dialysis, ascites drainage, peritoneal chemotherapy. Because the large omentum has the wandering covering function, the resistance in the drainage process is increased, especially the large omentum forms a unidirectional tissue flap in the drainage process to prevent ascites from flowing out, in order to place a tube for a long time and keep the drainage tube smooth, the head of the drainage tube is placed in a pelvic cavity, the drainage tube is placed in a place where the large omentum cannot cover, and the drainage tube is usually placed in a place where the large omentum cannot cover the pelvic rectum, the traditional abdominal cavity drainage tube placement method comprises cutting or puncturing a drainage tube by 20mm above a pubic symphysis by a middle line of more than 120mm, and the drainage tube can be placed in the abdominal cavity drainage tube under the indication of a laparoscope, and whether the drainage tube is located at a proper position or not is also judged in the use process, and if the drainage tube is separated from the pelvic cavity, the large omentum is wrapped to further influence liquid entering and exiting the abdominal cavity.

The drainage device with the structures of the top sac, the cysts, the penetrating sacs and the side sacs can solve the difficult problem of placing the traditional peritoneal dialysis tube and other peritoneal drainage tubes. The drainage device comprises water or saline, preferably, the drainage device comprises sugar water or saline, the sodium chloride content in the saline comprises 10-35%, the content of the midlower abdomen intestine comprises gas, the density of the internal structure of the whole midlower abdominal cavity is smaller than that of the water, and the drainage device comprises the water or saline, preferably, the drainage device comprises the saline or the saline, wherein the drainage device comprises the water or the saline, and the drainage device comprises the drainage device. The clamping balloon comprising the high-density liquid filler is downwards settled along with the movement or the change of the body position, the clamping balloon can reach the lowest position of the abdominal cavity by regulating and controlling the body position and the movement, preferably, the clamping balloon in the embodiment adopts an inelastic clamping balloon, the clamping balloon filling ratio comprises 10 to 80 percent, the total length of the drainage device comprises 150 to 500mm, the length of a hole section comprises 10 to 50mm, the shape of the hole comprises rectangle, ellipse, gap and the like, the perimeter of the edge of the hole is preferably 0.3 to 0.5 times of the perimeter length of a bracket tube of the device, the shortest distance of the adjacent holes is 5 to 10mm, the diameter of the drainage tube of the drainage device comprises 10 to 30mm, the bracket tube head end of the drainage device is preferably provided with a hole section, the optimal value of Kong Duanchang degrees is 10 to 50mm, the shape of the hole comprises rectangle, ellipse, the gap and the like, the optimal value of the perimeter of the edge of the hole is 0.3 to 0.5 times of the perimeter length of the bracket tube, and the shortest distance of the adjacent holes is less than 5mm; preferably, in embodiments employing a transcapsular structure, the anterior segment of the drainage tube is a rigid tube, which facilitates increased drainage rates. The placement procedure of this embodiment involves penetrating the abdominal wall into the abdominal cavity using a delivery catheter. In the embodiment of the bag penetrating structure, the front end of the drainage tube is a blind end, a guide hole is arranged in the center of the blind end, and the perimeter length of the guide hole is 2mm to 3mm. The guide wire is equivalent to loach guide wires in deep vein catheterization kits commonly found in the market at present, and the placement of the guide wire requires the assistance of a puncture needle and an expansion tube, such as the guide wire, the puncture needle and the expansion assembly in the vein catheterization kit of arow brand. During the use, use pjncture needle to stab the abdominal cavity along needle core lumen and put into the seal wire, penetrate expansion pipe expansion abdominal wall each layer structure along the seal wire, withdraw from the expansion pipe, the seal wire tail end passes the support pipe through the drainage tube pilot hole, promote forward through the support pipe, this drainage device enters into the abdominal cavity along the seal wire, through communicating pipe input screens sacculus filler, remove the seal wire, extract portable communicating pipe or seal the locking device of fixed communicating pipe, withdraw from the support pipe to the external section of drainage tube, make the truck be in upright position or half seat, this screens sacculus sinks into the rectum front gap under the action of gravity, the catheterization is accomplished. Preferably, the support tube is divided into two parts, the front section of the support tube is fixed with the front section of the drainage tube, and the inlets of the support tube are mutually communicated or the support tube and the drainage tube are combined into one, so that the outer section of the support tube can drain the current only by being in butt joint with the inner section, the stroke is reduced, the defect that the rigidity of the front section of the drainage device is improved, and the clamping saccule is influenced to sink to the front concave part of the rectum. More preferably, a through-bag continuous double-tube double-bag drainage device is adopted, and a preferable value of the distance between the double bags in the embodiment comprises 100mm to 250mm, wherein a proximal bag in the double bags is tightly attached to the inner side of an abdominal wall when in use, so that the front end of the drainage device is prevented from being changed in the abdominal cavity after the drainage device is pulled.

The utility model provides a pericardial cavity drainage device, pericardial cavity space is narrow and small, and local tissue motion range is big and fast, and the drainage volume is generally not big, and drainage device can adopt and wear the bag single tube structure, avoids local damage, and the bag anterior segment is flexible material pipe wall, and the screens sacculus includes inelastic screens sacculus wall, and drainage tube external diameter preferred value includes 6mm to 15mm. The drainage tube head end and the support tube head end are blind ends, a guide hole with the circumference of 3mm is arranged in the center of each blind end, the guide wire is equivalent to a guide wire for deep vein catheterization commonly used in the market at present, and the placement of the drainage device requires the assistance of a puncture needle and an expansion tube, such as the guide wire, the puncture needle and the expansion tube in an arow vein catheterization kit. During the use, use pjncture needle to stab the pericardial cavity and put into the seal wire along needle core lumen, withdraw from the pjncture needle, penetrate expansion pipe expansion along the seal wire and pass each layer structure by skin to the pericardial cavity, withdraw from the expansion pipe, the seal wire tail end passes drainage tube and support pipe through the drainage tube guiding hole, promote forward through the support pipe, this drainage device enters into the pericardial cavity along the seal wire, through communicating pipe input screens sacculus filler, remove the seal wire, extract portable communicating pipe or seal the locking device of fixed communicating pipe, withdraw from the support pipe and reach the external section of drainage tube.

Perianal abscess drainage device is a common surgical disease, the operation at the perianal abscess is difficult to debridement and suture once, the use of the drainage device is particularly important, the circumference of the outer side wall of the drainage tube preferably comprises 6-30 mm, the length of the drainage tube preferably comprises 100-400 mm, and the placement mode of the embodiment comprises direct placement in the operation and placement after external blind detection.

A gallbladder drainage tube, in which biliary tract inflammation has a high incidence in the middle-aged and later-aged population, and some patients with cholecystolithiasis have undergone cholecystectomy, and the loss of gallbladder causes digestive tract dysfunction in a substantial part of patients, thereby inducing chronic digestive tract inflammation. Gall bladder lithiasis is a disease caused by gall bladder itself, even if calculus is taken out, the gall bladder lithiasis often recurs, so that the gall bladder loses the possibility of functional rehabilitation. The cholecystectomy is more risky in some old and weak biliary tract inflammatory patients, and when general drug treatment is lost, especially when the gallbladder neck is blocked by stones, the internal tension of the gallbladder rises and local infection mutually promotes to cause malignant circulation, and at the moment, percutaneous transhepatic and biliary tract puncture drainage is a frequently selected treatment method. Previously, the traditional practice is to place a rigid polymeric tube inside the gall bladder, and the puncture tube passes through the skin, subcutaneous tissue, abdominal wall muscle, peritoneum, liver capsule, liver parenchyma and gall bladder wall to enter the gall bladder cavity. The tube is fixed on the skin surface after being led out of the body surface, and the method has the defects of damage to the gall bladder, falling off of the tube, blockage of the drainage tube and the like caused by the front end of the tube. Because the puncture of the gallbladder needs to pass through liver tissue covered on the gallbladder, the contact of the side hole or the front end of the fallen rigid catheter with the liver tissue can cause bleeding, which becomes a complication of the traditional gallbladder puncture.

The main drainage part of the embodiment is the gall bladder, and in the acute cholecystitis period, stones and bile or pus in the gall bladder are drained out of the body, and other treatment methods are matched to reduce and control the inflammation of the gall bladder, so that sinus tracts are formed on the surfaces of the gall bladder cavity and the skin along with the time. The preferred values for the length of the draft tube in this embodiment include 300mm to 400mm and the preferred values for the circumference of the outside wall of the draft tube include 15mm to 40mm. The gall bladder is less than 150mm from the skin surface, except for individual obese individuals. Preferably, the drainage device with the structure of the penetrating bag penetrating double tube is adopted, and the flexible communicating tube has the function of being matched with the gall bladder puncture to prevent the gall bladder content from overflowing. Because bile often contains silt-like particles and other sediments, in order to more conveniently take out calculus in the gall bladder, preferably, the drainage device comprises two sections of support pipes, the front section of the drainage pipe bladder and the inner section of the support pipe body are integrated into one, the size of the side hole of the rigid pipe is not limited, and the side hole of the rigid pipe is beneficial to leading the larger calculus to enter the body of the head of the drainage pipe to be conveyed. The drainage device is characterized in that a drainage tube inlet is formed in the front section of a drainage tube bag, the perimeter of the drainage tube inlet preferably comprises 30-70 mm, and the shape of a hole comprises an ellipse, a rectangle and a slit. The front end of the drainage tube and the front end of the support tube in the drainage device are blind ends, the centers of the two blind ends are provided with guide wire guide holes, the circumferences of the guide holes comprise 3mm to 6mm, the guide wires are equivalent to deep vein catheterization guide wires common in the market at present, and the device is put into the vein catheterization kit needing the assistance of a puncture needle, the guide wires and an expansion tube, such as the guide wires, the puncture needle and the expansion tube in the arow brand vein catheterization kit. During the use, puncture needle is used to pierce the gall bladder cavity, guide wire is placed along the needle lumen, the puncture needle is withdrawn, the guide wire penetrates into the expansion tube along the guide wire to expand each layer of structures of the abdominal wall and the gall bladder wall, the expansion tube is withdrawn, the tail end of the guide wire penetrates through the drainage tube and the support tube through the drainage tube guide hole and is pushed forward through the support tube, the drainage device enters the gall bladder along the guide wire, the clamping saccule filler is input through the communicating tube, the locking device of the movable communicating tube or the sealed fixed communicating tube is pulled out, the guide wire is withdrawn, and the placement of the catheter is completed.

Another embodiment for gall bladder drainage includes a drainage device of a top bag and double tube structure, and the structure is that a support tube is limited by a fixed communicating tube, so that the possibility that the support tube runs to the outside of a drainage tube is small, the perimeter of a side hole of the drainage tube can be designed to be larger than the perimeter of the support tube, the support tube enters the inside of a gall bladder along the communicating tube and the drainage tube, and due to the shrinkage or negative pressure suction effect of the gall bladder, the gall flows out of the body along the support tube, and meanwhile, granular stones flow out of the gall bladder along with the drainage of the gall bladder. The placement of this embodiment requires placement of the clamping balloon into the gallbladder with the assistance of a delivery catheter that requires the assistance of a guidewire and a dilation tube, such as a guidewire, a puncture needle, and a dilation tube in an arow-brand intravenous catheterization kit. During the use, use pjncture needle to stab gall bladder and put into the seal wire along needle core lumen, pull out the pjncture needle, penetrate expansion pipe expansion abdominal wall each layer structure and gall bladder wall along the seal wire, withdraw from the expansion pipe, put into the transport catheter along the seal wire and reach the gall bladder, withdraw from the seal wire, promote this drainage device along transport catheter entering gall bladder lumen forward through the support pipe, input screens sacculus filler through the locking device that is connected with communicating pipe, withdraw from the support pipe to the drainage tube external section, withdraw from transport catheter, drainage device is in standby state. The preferred values for the length of the drain tube in this embodiment include 300mm to 1000mm, the preferred values for the circumference of the drain tube include 10mm to 45mm, the drain device aperture section is positioned immediately proximal to the retaining balloon, the aperture section is positioned within the gallbladder, the aperture section length includes 30mm to 80mm, the circumference of the drain tube wall aperture includes 10mm to 80mm, to maximize the clearance of stones through the aperture section. In particular, the tube wall of the drainage tube hole section except the hole is 2 to 5 longitudinal row strip-shaped tube walls, and the width of the strip-shaped tube wall comprises 1 to 3mm; the circumference of the stent tube is 12mm to 45mm, the structure of the front section hole of the stent tube comprises a plurality of gaps which are arranged along the longitudinal axis of the stent tube, the lengths of the gaps are 30mm to 50mm, preferably, the tube wall of the stent tube hole section except the holes is in a structure of 2 to 5 longitudinal strip-shaped tube walls, the width of each strip-shaped tube wall comprises 1mm to 3mm, and the longitudinal strip-shaped tube wall has an radian protruding towards the periphery of the stent tube; larger stones enter the interior of the stent tube from relatively wide gaps and have the opportunity to be carried out of the body.

In the non-drainage state, the flushing fluid can be input through the tail end of the drainage tube, or the flushing fluid is input through a section of tubular structure attached to the outer side of the drainage tube, and after the gall bladder in an inflammation state or the gall bladder tube and the common bile duct connected with the gall bladder in a inflammation state are drained for a period of time, the inflammation is gradually resolved, the drainage device is pulled out, and the treatment is carried out temporarily; another advantage of this embodiment is that the support tubes of different diameters may be used sequentially to expand the cholecystokinin opening, providing access for possibly thicker medical devices into the gallbladder, for example, for insertion of a cholecystoscope for further manipulation.

The common bile duct rehabilitation drainage device which is placed through the skin and the liver has a plurality of reasons for the common bile duct dysfunction, and the reasons which can be listed include cholangitis, bile duct calculus, biliary sclerosis, common bile duct and surrounding tissue tumor. In order to improve the blocking state of the common bile duct, it is common practice to place a stent tube at the common bile duct through the duodenum, and the common bile duct stent placed along with the time has a certain proportion of stent tubes blocked after 3 months, which is more obvious in the stent tubes of plastic products, and the blocking situation caused by tumor causes is particularly serious. The embodiment adopts a percutaneous transhepatic placement common bile duct drainage device, and a clamping balloon of the device is placed in the duodenum. Step 1 of the device use includes percutaneously placing a guidewire that is percutaneously, subcutaneous tissue, muscle, liver, intrahepatic bile duct, common bile duct, to the duodenum. Step 2, expanding a puncture channel along a guide wire, particularly expanding skin, subcutaneous, muscle, liver and intrahepatic bile duct walls, withdrawing the expansion tube, enabling the tail end of the guide wire to pass through the drainage tube and the support tube, pushing the support tube along the guide wire direction, and driving the drainage device to enter the duodenum; step 3, inputting a clamping balloon filler, wherein the filler is preferably air or water, and pulling out a movable communicating pipe or closing a locking device; step 4, drainage and intermittence; and 5, taking out the drainage device. The method for arranging the drainage device further comprises the steps of arranging the guide wire reversely by an operator on an operating table and arranging the drainage device along the guide wire.

The drainage method has the advantages that 1. The bile flow of the cholecyst tube is not influenced; 2. blockage is not easy to occur; 3. the rhythm of bile secretion is not affected; 4. less affecting pancreatic duct activity.

For the purposes of the invention, the embodiment is preferably a drainage device with a bag penetrating structure or a side bag structure, and the bag penetrating structure or the side bag structure is beneficial to guiding the whole device to enter corresponding positions along a guide wire through a guide wire guide hole arranged at the blind end of the drainage tube; the drainage tube in the embodiment is a porous flexible tube in the inner part of the bile duct, and particularly comprises a fiber braided mesh tube or a mesh tube with holes in a biaxially stretched polytetrafluoroethylene material, wherein the fiber material of the fiber braided mesh tube comprises terylene fibers, polyethylene fibers, polyurethane fibers, nylon fibers and at least two combinations of the fibers, the preferred value of the circumferential length of the drainage tube comprises 15mm to 45mm, the drainage tube inlets of the embodiment are distributed at the front section and the rear section of the drainage tube bag, and the drainage tube inlets on the drainage tube at the rear section of the bag receive bile infusion of the intrahepatic bile duct, the left hepatic duct or the right hepatic duct and the gall bladder tube. The secretion of the pancreatic duct can be singly discharged to the duodenum, and can also enter the drainage tube through the hole on the drainage tube.

The positioning balloon in this embodiment is positioned in the duodenum, and the proximal shaping positioning balloon is preferably used to further facilitate protection of the duodenal papilla. In the embodiment, the shape of the drainage tube hole section and the hole passing through the internal support tube hole section comprises a circle, an ellipse, a rectangle and a gap, the perimeter of the edge of the drainage tube inlet is 0.1 to 0.8 times of the perimeter of the support tube, and the minimum distance between the adjacent holes is less than 20mm; the length of the bore section comprises 20mm to 200mm. The perimeter of the central guiding hole of the blind end of the drainage tube comprises 3mm to 6mm. The structural characteristics of the guide wire, the puncture needle for placing the guide wire and the expansion tube comprise related accessories in an arow-brand venipuncture bag assembly.

The protection of the present invention is not limited to the above embodiments. Variations and advantages that would occur to one skilled in the art are included in the invention without departing from the spirit and scope of the inventive concept, and the scope of the invention is defined by the appended claims.

Claims

1. A drainage device, comprising: a drainage tube (200), a clamping balloon (100) connected with the drainage tube (200), a filler filling and discharging accessory (30) and a bracket tube (600) movably arranged in the drainage device; the drainage tube (200) comprises: a drain head (210), a drain body (220); wherein, the head of the drainage tube is provided with a drainage tube inlet (201), and the body of the drainage tube is provided with a drainage tube outlet (202); at least one part of the tube wall of the drainage tube is a flexible tube wall; the stent tube (600) comprises a rigid tubular structure; the support tube head section is provided with a support tube inlet (601), and the support tube tail section is provided with a support tube outlet (602); the capsule wall of the clamping saccule (100) comprises a high polymer film material, and the clamping saccule (100) is communicated with the filler filling and discharging accessory (30) and is connected with the drainage tube (200); a shaping strip (14) is arranged in the clamping balloon (100), the shaping strip (14) is of a tubular structure, and two ends of the tube wall of the shaping strip (14) are in sealing connection with or continuous with the balloon wall of the clamping balloon (100); the filler fills and puts annex includes: a communication pipe (300) and a locking device (330) connected to the communication pipe (300); the communicating pipe (300) is communicated with the clamping balloon (100); wherein the communicating tube (300) and the locking device (330) are configured as a mobile communicating tube (310) and a locking device (330), at least one section of the mobile communicating tube (310) is of a rigid tubular structure, and the rigid tubular structure passes through the locking device (330) in a sealing and movable way, the locking device (330) connected with the mobile communicating tube (310) comprises a sealing block (331), and the sealing block (331) is in sealing connection with the capsule wall or the isolation piece (12) of the clamping balloon (100).

2. The drainage device of claim 1, further comprising a snap balloon filler; the clamping balloon filler comprises a fluid; the fluid comprises a gas and/or a liquid; and/or, the drainage tube head (210) is provided with a plurality of drainage tube inlets, the front end of the drainage tube is a blind end, and the center of the blind end is provided with a guide hole; and/or the drainage tube (200) comprises a porous material woven or spun of fibrous material, or a biaxially stretched polytetrafluoroethylene material; and/or the stent tube (600) comprises one or a combination of at least two of the following structures: a spiral shaped wire, a spiral slit, a C-shaped slit; and/or the shape of the stent tube (600) and the positional relationship with the drainage tube (200) include one of the following four: a) The support tube (600) is fixed at the head of the drainage tube, and one section of the support tube is provided with an elastic bending shape; b) The stent tube (600) comprises two sections of rigid tubular structure separated from each other, at least one of which is movably arranged inside the drainage tube; c) At least a portion of the stent tube (600) is secured inside the drain tube; d) At least a portion of the stent tube (600) is in movable sealing connection with the drain tube outlet (202); and/or the fixing mode of the bracket tube (600) and the drainage tube (200) comprises one of the following three modes: a) One part of the drainage tube (200) is connected with one part of the support tube (600), and the connected part comprises the head end of the drainage tube connected with the head end of the support tube or the tail end of the drainage tube connected with the tail end of the support tube; b) The cross section winding circumference of at least one part of the bracket tube is larger than the inner edge circumference of the cross section of the cavity of the drainage tube at one part of the drainage tube body; c) The drainage tube body is provided with a rigid round bayonet, and the circumference of the inner edge of the round bayonet is smaller than the circumference of one part of the support tube; and/or the number of the groups of groups,

The clamping balloon (100) comprises two balloon bodies; and/or, the click balloon filler comprises one of: water, white oil, silicone oil, air, a combination of water and white oil or silicone oil, a combination of air and water, a combination of air and white oil or silicone oil; and/or, further comprising a breaker tool, the breaker tool comprising: a pipe section (400), a metal tip section (401), a filler passage hole (402), a filler outlet (403), and a conical section (404); the pipe part (400) is a rigid pipe, the wall of the head section of the pipe part (400) is provided with the filler intersecting holes (402), and the shape of the head section of the pipe part (400) comprises a straight tubular structure or an arc-shaped bent tubular structure in an unconstrained state; and/or, further comprising a breaking sleeve, wherein the breaking sleeve comprises a rigid outer sleeve (520) and a rigid inner sleeve (510), the outer sleeve (520) comprises a pipe body and a metal blade (521), the metal blade (521) is arranged on the inner side of the pipe wall at the front end of the outer sleeve (520), the metal blade (521) faces the axial direction of the outer sleeve (520), and the plane of the metal blade (521) is parallel to the axial direction of the head end of the outer sleeve (520); the outer side of the front end pipe wall of the inner sleeve (510) is provided with a blade adapting groove (511) which is adapted to the metal blade (521); and/or, the communication tube (300) and the locking device (330) are further configured to: the fixed communicating tube (320) and the locking device (330) comprise, the fixed communicating tube (320) is communicated with the clamping balloon (100), the locking device (330) connected with the fixed communicating tube (320) comprises any one or a combination of at least two of the following structures, and the locking device comprises: luer lock ports, plugs, clamps, adhesives, ports with screws, sealing blocks (331), valves, and filler storage bags; and/or, the mobile communication pipe (310) is connected in series with the bracket pipe (600), the bracket pipe (600) is positioned near the mobile communication pipe (310), and the two are mutually communicated; and/or, the connection mode of the drainage tube head (210) and the clamping balloon (100) comprises one of the following connection modes: a) The front end of the drainage tube head (210) is connected with the clamping balloon (100); b) The drainage tube head (210) passes through the clamping balloon (100); c) The drainage tube head (210) surrounds the clamping balloon (100); d) The side wall of the drainage tube head (210) is connected with the capsule wall of the clamping balloon (100); and/or, the positional relationship between the communicating tube (300) and the drainage tube (200) includes one of the following three forms: a) At least one section of communicating pipe (300) runs inside the drainage tube (200); b) At least one section of the drainage tube (200) runs inside the communicating pipe (300), the communicating pipe (300) is a fixed communicating pipe (320), and the drainage tube (200) passes through the clamping balloon (100); c) The drainage tube (200) and the communicating tube (300) are respectively connected with the clamping balloon (100) and are not sleeved with each other; and/or the external part of the drainage device is connected with a traction weight or an elastic traction belt; and/or further comprising a rigid delivery catheter (700), the delivery catheter (700) comprising a rigid high molecular polymer tube (701), the tube (701) being open at both ends; and/or the delivery catheter (700) has at least two tearable pre-cuts (702), the pre-cuts (702) being distributed longitudinally along the delivery catheter (700), the pre-cuts (702) extending to a proximal port edge and a distal port edge of the delivery catheter (700).

3. Drainage device according to claim 1 or 2, characterized in that the method of use of the device comprises the following steps:

step 1, placing the drainage device;

step 2, conveying the filler to the clamping balloon (100) through the communicating pipe, and sealing the clamping balloon (100);

step 3, comprising forming a drainage procedure or a closing procedure by movement of the stent tube (600): wherein, the drainage process includes: the stent tube (600) is moved to a narrow part of a drainage channel, the flexible drainage tube (200) is expanded from the inside of the narrow part of the drainage channel, the drainage substance is moved out of the drainage gap, and the drainage device enters a drainage state; wherein the closing process comprises: the stent tube (600) is moved out of the narrow part of the drainage channel, the stent tube (600) is removed from the narrow part of the drainage channel, the tube wall of the flexible drainage tube (200) at the narrow part of the drainage channel is collapsed and closed, the drainage process is ended or enters a slow process, and the drainage device is in a non-drainage state;

step 4, removing the drainage device, comprising: breaking the tightness of the clamping balloon (100), removing the filler of the clamping balloon (100), and pulling out the drainage device.

4. The drainage device of claim 3, wherein the method of implanting the drainage device comprises at least one of: a) Jacking the top end of the drainage tube (200) and/or the clamping balloon (100) from the inside of the drainage tube (200) by using the support tube (600), wherein the support tube (600) drives the clamping balloon (100) to enter the drainage gap; b) The head end of the support tube (600) is connected in series with the movable communicating tube (300) firstly, the movable communicating tube (300) passes through the sealing block (331), the head end of the support tube (600) directly or indirectly props against the sealing block (331) through the inside of the drainage tube (200), and the clamping saccule (100) is brought into the drainage gap along with the pushing of the support tube (600) towards the drainage gap; c) A delivery catheter (700) is placed in a drainage gap in advance, then a clamping balloon (100) of a drainage device is pushed into the drainage gap along the delivery catheter (700), and the delivery catheter (700) is withdrawn after the clamping balloon filler is input; or at least one part of the drainage device is wrapped by a conveying catheter (700), then the clamping balloon (100) is driven to enter a drainage gap, and the conveying catheter (700) is withdrawn after the clamping balloon filler is input; d) A guide wire is placed in a drainage gap in advance, the guide wire comprises a tubular guide wire or a loach guide wire, the tail end of the guide wire passes through a blind end guide hole (218) of the drainage tube or passes through a side hole of the head (210) of the drainage tube to enter a tube cavity of the drainage tube (200) and a tube cavity of the support tube (600), then the guide wire passes through the tail end of the support tube (600) and the tail end of the drainage tube (200), and then the support tube (600) is pushed into the drainage gap along the guide wire and drives the clamping balloon (100) to enter the drainage gap; e) By one of the four methods a, b, c, d, the drainage device which is put into the digestive tract moves to the position of the digestive tract which is farther away from the oral cavity under the peristaltic action of the digestive tract and/or the gravity traction; f) The clamping balloon (100) is settled to the pelvic cavity under the action of gravity by one of the four methods a, b, c, d, including settlement to the anterior rectal depression; and/or, the filler is input through the communicating pipe (300), and the process of closing the clamping balloon (100) comprises one of three modes: a) The filler is input through a mobile communicating pipe (310), the mobile communicating pipe (310) is pulled out, and a sealing block (331) automatically seals a gap left after the mobile communicating pipe (310) is pulled out; b) Opening a locking device (330) connected to the fixed communication pipe (320), inputting the filler through the fixed communication pipe (320), and closing the locking device (330) connected to the fixed communication pipe (320); c) A clamping balloon filler is input into the clamping balloon (100) through a structure that a movable communicating pipe (310) is connected with a drainage tube (200) bracket in series, the movable communicating pipe (310) and a bracket tube (600) connected with the movable communicating pipe in series are pulled out, and the sealing block (331) seals the clamping balloon (100); and/or further comprising a clamping balloon (100) provided with the shaping strip (14) for conveying the filler through a communicating tube (300); the method for the filler of the clamping balloon (100) to enter the clamping balloon (100) provided with the shaping strip (14) comprises the following steps: the clamping balloon filler enters the clamping balloon (100) through a balloon wall filler intersecting hole (141) or a molding strip connecting hole (140); the capsule wall filler intersecting holes (141) are positioned on the capsule wall of the free part of the clamping balloon; the molding strip connecting bag holes (140) are positioned on the pipe wall of the molding strip (14); the path for the filling of the filler through the molding strip web hole (140) includes one of four paths: a) The filler is input through the distal end of the shaping strip (14), in this case, the proximal end of the shaping strip connecting bag hole (140) is sealed by the blind end of the drainage tube connected with the shaping strip connecting bag hole, and the distal end of the shaping strip (14) is communicated with the filling and discharging accessory (30); b) The filler is input through the proximal end of the molding strip connecting bag hole (140), in this case, the distal end of the molding strip connecting bag hole (140) is sealed, the proximal side of the molding strip connecting bag hole (140) is in sealing connection with the blind end of the drainage tube (200), the movable communicating pipe (310) passes through the blind end of the drainage tube (200) and the sealing block (331) connected with the blind end of the drainage tube (200), the clamping balloon filler is input into the molding strip through the movable communicating pipe (310), and the clamping balloon filler enters the inside of the clamping balloon (100) through the molding strip connecting bag hole (140); c) The connecting bag hole (140) is directly connected with the sealing block (331) in a sealing way, and the clamping balloon filler passes through the connecting bag hole (140) and the sealing block (331) through the movable communicating pipe (310) to enter the clamping balloon (100); d) The fixed communicating pipe (320) is directly communicated with the shaping strip (14) near the shaping strip connecting hole (140), and the filler enters the clamping balloon (100) through the proximal end of the shaping strip and the connecting hole (140) by the fixed communicating pipe (320); the path for filling the filler through the wall filler through hole (141) comprises: the filler passes through the fixed communicating pipe (320) and the locking device (330) which are communicated with the capsule wall filler communicating hole (141); or the clamping balloon filler passes through the capsule wall filler intersecting hole (141) and the sealing block (331) which is in sealing connection with the capsule wall filler intersecting hole (141) through the movable communicating pipe (310) to enter the clamping balloon (100).

5. The drainage device of claim 3, comprising forming the drainage procedure by movement of the stent tube (600) comprising one of the following methods: a) Stent tube (600) external expansion method: pushing the stent tube (600) outside the drainage tube (200), wherein in a non-drainage state of the drainage tube (200), the stent tube (600) is positioned at the position close to the center of a narrow part of a drainage channel or outside the drainage channel, and the front end of the stent tube (600) can be moved from the position close to the narrow part of the drainage channel and passes through the narrow part of the drainage channel to finish drainage, and meanwhile, the flexible drainage tube wall is folded or folded; b) The stent tube (600) internal expansion method is characterized in that the stent tube (600) is positioned in a drainage gap in a state of waiting for drainage, the drainage device is provided with the stent tube (600) which is movably arranged, the stent tube (600) is fixed at the head part (210) of the drainage tube, when the drainage tube body part is pulled, the front end of the stent tube (600) connected with the drainage tube (200) is moved to a drainage channel narrow position and penetrates through the drainage channel narrow position, the drainage channel is opened, the drainage process is completed, and meanwhile, the flexible drainage tube wall folds or the flexible drainage tube wall folds; c) The direct push-pull method of the support tube (600), under the condition that a part of the support tube (600) is positioned outside the drainage tube (200), the drainage tube (200) is fixed in a pulling way, the outer part of the support tube (600) is positioned inside the drainage tube (200) and pushed into the drainage tube (200), the front end of the support tube (600) is moved to and penetrates through the narrow part of the drainage channel, and the drainage channel is opened.

6. The drainage device of claim 3, wherein the method of removing the stent tube (600) from the stenosed site of the drainage channel comprises one of 3 means: a) In the external expansion mode of the stent tube (600), the stent tube (600) is pulled outside the drainage tube (200), and the stent tube (600) can be moved out of the narrow part of the drainage channel, and simultaneously the flexible drainage tube wall folds or the flexible drainage tube wall folds; b) In the stent tube (600) internal expansion mode, loosening the tube wall of the pulled drainage tube (200), removing the stent tube (600) connected with the head part (210) of the drainage tube from a drainage channel towards a drainage cavity, wherein the power in the removing process is derived from a reverse action mechanism movably arranged on the stent tube (600), and is accompanied by stretching at the folds of the tube wall of the flexible drainage tube or folding the tube wall of the flexible drainage tube; c) In the case where a portion of the stent tube (600) is movable outside the drainage tube (200), the portion of the stent tube (600) located outside the proximal side of the drainage tube (200) is pulled outside the drainage tube (200), and the stent tube (600) is moved to the proximal side of the drainage channel stenosis.

7. The drainage device of claim 3 wherein the method of breaking the seal of the cartridge balloon comprises at least one of: a) In a top bag or encapsulation mode, the head end of the stent tube (600) is pushed from the inside of the drainage tube (200) along the wall of the pulled drainage tube (200) and is contacted with the clamping balloon (100), and as the forward pushing force of the stent tube (600) is increased, the weak point or the part with the largest stress of the clamping balloon (100) is broken; b) Using a breaking cutter, placing the breaking cutter into a support tube (600), wherein a metal tip (401) of the breaking cutter is positioned at the near side of a head section breaking cutter outlet of the support tube (600), moving the support tube (600) towards the clamping balloon (100), confirming that the support tube (600) reaches the clamping balloon (100), fixing a drainage tube (200) and the support tube (600), pushing the metal tip (401) of the breaking cutter and extending out of the breaking cutter outlet on the support tube (600), and the metal tip (401) of the breaking cutter pierces the capsule wall or a spacer (12) of the clamping balloon (100), and removing the clamping balloon filler from the clamping balloon (100) and then withdrawing the breaking cutter; c) The method comprises the steps that a broken sleeve is used, inner and outer sleeves (510 and 520) of the broken sleeve are embedded with each other, the front end of the broken sleeve is pushed forwards along the outer side of the tube wall of the drainage tube (200) or the tube wall of a fixed communicating tube (320), the front end of the broken sleeve is confirmed to be contacted with the clamping balloon (100), the inner sleeve (510) of the broken sleeve is pulled back towards the proximal end, the drainage tube (200) or the communicating tube (300) is pulled, the outer sleeve (520) of the broken sleeve is pushed forwards, a metal blade (521) at the inner side of the front end of the broken sleeve breaks the capsule wall of the clamping balloon (100), and clamping balloon fillers flow out of the clamping balloon (100); d) Breaking the tightness of the clamping balloon (100) by opening a locking device (330) of the fixed communication tube (320) or breaking the integrity of the fixed communication tube (320) outside the body, the filler being removed from the clamping balloon (100); e) The stent tube (600) is withdrawn from the drainage tube (200), the tail end of the drainage tube (200) or the fixed communicating tube (320) penetrates through the lumen of the stent tube (600), the front end of the stent tube (600) is pushed to the capsule wall of the clamping balloon (100) along the drainage tube (200) or the fixed communicating tube (320), and the weak point or the stressed maximum part of the clamping balloon (100) is broken along with the increase of forward pushing force of the stent tube (600).

8. A medical kit comprising the drainage device of any one of claims 1-2 and at least one component comprising: negative pressure or vacuum source, extension tube, fluid collection container, sterile filter, lubricant, syringe, suture, luer lock interface male port, luer lock interface female port, plug, clip, scissors, anastomotic tubing, loach guide wire, zebra guide wire, expansion tube, push tube, guide catheter.

9. A method for manufacturing a retention balloon and a structure connected to the retention balloon for use in a drainage device according to claim 1 or 2, comprising: step 1, manufacturing a basic pipeline, and step 2 comprises at least one or a combination of at least two of the following: the basic pipeline is arranged and jointed, provided with holes, provided with a locking device (330), provided with a movable communicating pipe (310) and provided with a bracket pipe (600).

10. The method for manufacturing a retention balloon and a structure for connecting the retention balloon in a drainage device according to claim 9, wherein the basic pipeline comprises: a balloon-tube structure basic pipeline and a tubular structure basic pipeline; the basic pipeline of the sac tube structure comprises: the bag part and the pipe part are connected and communicated with each other, the structure of the bag part comprises a single bag structure or a double bag string formed by two bag structures, and the two bag structures of the double bag string are connected and communicated with each other through a pipe between the bags; the basic pipeline of the balloon pipe structure comprises the following basic pipelines: a single-bag tube (901), a double-pass single-bag tube (902), a double-pass double-bag tube (905), a single-pass double-bag tube (907), a single-blind double-bag tube (908) and a single-blind single-bag tube (909); the tubular structure basic pipeline comprises a straight pipe (903) and a blind end pipe (904); the base pipe comprises a flexible material; and/or, shaping the two-way single-balloon tube (902): one B pipe which is communicated with the bag part of the two-way single bag pipe (902) is turned inwards to pass through the inside of the bag part, and the B pipe is at least connected with the root part of the A pipe of the two-way single bag pipe (902) in a sealing way to form a shaping strip (14); the shaping bar (14) comprises a tubular structure between the root portions of the A, B tubes; and/or, under the condition of positive pressure expansion inside the bag part of the double-pass single-bag pipe (902), the distance X1 between the two pipe roots in the joint state of the shaping strip (14) is smaller than the distance X2 between the two pipe roots in the joint state of the non-shaping strip, and the ratio of X1 to X2 comprises 5% to 90%.