CN106580387B - Medical body cavity internal pressure applying device - Google Patents

Medical body cavity internal pressure applying device Download PDF

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Publication number
CN106580387B
CN106580387B CN201611181112.7A CN201611181112A CN106580387B CN 106580387 B CN106580387 B CN 106580387B CN 201611181112 A CN201611181112 A CN 201611181112A CN 106580387 B CN106580387 B CN 106580387B
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umbrella
pressure applying
branch
rib
body cavity
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CN201611181112.7A
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CN106580387A (en
Inventor
田兆兴
闫崴
郑亚安
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Beijing Jishuitan Hospital
Peking University Third Hospital
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Beijing Jishuitan Hospital
Peking University Third Hospital
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/00867Material properties shape memory effect
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B2017/12004Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for haemostasis, for prevention of bleeding

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Reproductive Health (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

The medical body cavity internal pressure applying device comprises an openable pressure applying umbrella. The pressure umbrella comprises: a plurality of main ribs; umbrella membranes attached to the plurality of main ribs; a fixing rod; a plurality of first branch ribs; and a plurality of second branch ribs, a proximal end of each second branch rib being connected to a second end of the fixation rod. The device can obviously increase the compression area of the fundus of the stomach, can provide low-pressure interval compression, can ensure the blood supply of the esophagus and the mucosa of the fundus of the stomach under pressure, and does not cause necrosis of the mucosa; after the device is placed, the gastroscopy can be further carried out through the esophageal stent and the hollow passage of the fundus umbrella, so that diagnosis and treatment possibility are provided for hemostasis under the gastroscope and hemostasis of bleeding points outside pressed parts; the placement and the taking out are convenient; can provide long-term compression treatment or prophylactic treatment of bleeding of patients with severe varicose veins, and expands treatment indications.

Description

Medical body cavity internal pressure applying device
Technical Field
The present invention relates to a device for applying pressure or stopping bleeding in a body cavity, in particular near the fundus of the digestive tract.
Background
About 120 ten thousand people die each year due to cirrhosis in the world, and the number of people increases year by year, most of the causes are esophageal gastric fundus varices rupture and bleeding caused by cirrhosis, and the common hemostasis methods are medicines, instruments, interventional operations, open abdominal operations and the like. For acute stage treatment of acute severe hemorrhage, the currently international preferred common means is still a three-lumen two-balloon tube, also known as a Sengstaken-Blakemore tube or a Minnesota tube, which is used by a small number of doctors to stop bleeding by compression, using a Linton-Nachlas tube (only one gastric balloon of about 500ml, no esophageal balloon). Although the hemostatic devices described above have long played an important role in clinical most esophageal fundus varices rupture bleeding, many problems have been found during use, such as common complications including esophageal fundus mucosa necrosis, mucosal ulcers, secondary avulsion bleeding upon removal, rare complications including esophageal rupture, choking airways, and the like, other adverse aspects including placement of tubing, compression inefficiency, difficulty in compression adjustment, balloon rupture, interference with further gastroscopy, and the like.
In addition, as shown in FIG. 1, the fundus 60 of the human digestive tract is immediately adjacent to the distal end of the esophagus 50. When bleeding near the fundus, the local pressure of existing balloon or other hemostatic devices is typically not adjustable, although compression hemostasis may be achieved by accessing the site. Thus, there is a need for a hemostatic device or apparatus that applies pressure to the fundus hemorrhage site during hemostasis that can be adjusted accordingly as needed during hemostasis.
Disclosure of Invention
The object of the present invention is to provide a medical body cavity internal pressure applying device which can be used, for example, for applying pressure to the fundus of the digestive tract to stop bleeding and which overcomes some or some of the above-mentioned drawbacks.
The medical body cavity internal pressure applying device of the present invention includes an openable and closable pressure applying umbrella having an umbrella tip and an open-close end, the pressure applying umbrella comprising:
a plurality of main ribs converging toward an umbrella tip of the pressing umbrella in an opened state of the pressing umbrella;
umbrella membranes attached to the plurality of main ribs;
a stationary bar having a first end and a second end, wherein the first end of the stationary bar is disposed adjacent an umbrella tip of the pressure umbrella and the second end of the stationary bar is disposed adjacent an open and closed end of the pressure umbrella;
a plurality of first branch ribs, each first branch rib having a proximal end and a distal end, wherein the proximal end of each first branch rib is fixedly connected to the first end of the fixation rod and the distal end extends toward the top end of the umbrella and is fixedly connected to the corresponding main rib; and
a plurality of second branch ribs, each second branch rib having a proximal end and a distal end, wherein the proximal end of each second branch rib is connected to the second end of the fixation rod and the distal end extends toward the top end of the umbrella and is fixedly connected to the corresponding main rib,
wherein the first branch rib and the second branch rib are made of elastic materials, the connection point of the first branch rib and the main rib is more adjacent to the top end of the umbrella than the connection point of the second branch rib and the main rib, and the top end of the umbrella is provided with an opening.
The device of the present invention provides low pressure interval compression due to the interspersed configuration of the main ribs, while not interfering with microscopy.
According to one embodiment of the present invention, the medical body cavity internal pressure applying device may further include a radially expandable cylindrical stent or a cylindrical stent formed with a hollow passage, the cylindrical stent being connected to the umbrella tip of the pressure applying umbrella such that the hollow passage of the cylindrical stent communicates with the opening of the umbrella tip of the pressure applying umbrella. The cylindrical stent is preferably formed in a mesh tube structure so as to provide low pressure interval compression to the esophageal site as well.
According to one embodiment of the invention, a connection transition may be formed between the cylindrical support and the tip of the compression umbrella, the connection transition having an outer diameter smaller than the outer diameter of the cylindrical support when the cylindrical support is in the expanded state. The connecting transition portion is preferably a truncated cone portion with its tapered end facing the tip of the pressure umbrella.
According to one embodiment of the invention, the proximal end of each second branch rib is longitudinally slidably connected to the second end of the fixation rod. In this case, a plurality of longitudinal runners may be circumferentially spaced around the second end of the fixation rod to receive a corresponding second branch rib.
The medical body cavity internal pressure applying device of the present invention may further comprise a plurality of adjustment wires, each of which is connected to the proximal end of the second branch rib and extends at least out of the opening of the tip of the pressure applying umbrella.
According to a further preferred embodiment of the invention, each runner of the fixation rod may be provided with a series of stop means, such as a slot diameter constriction, longitudinally to stop the proximal end of the second branch rib sliding thereto. The longitudinal grooves are preferably provided as blind grooves formed in the circumferential wall of the fixing bar, in order to avoid entanglement between the adjustment wires.
According to one embodiment of the invention, the medical body cavity internal pressure applicator may further comprise a removable sleeve that is externally applied to the pressure umbrella and/or the cylindrical support to maintain it in a closed or contracted state and automatically releases the pressure umbrella and/or the cylindrical support to assume an open or expanded state after being removed.
According to an embodiment of the invention, the first branch rib, the second branch rib and/or the cylindrical support may be at least partly made of a shape memory alloy material, so that the pressure applying umbrella and/or the cylindrical support can be restored to the closed state or the contracted state by changing the temperature. The elastic memory alloy preferably at least partially loses elasticity or returns to its original shape at about 50 ℃ (40 ℃ to 60 ℃).
According to one embodiment of the invention, the umbrella membrane can be made of medical polymer material. Alternatively, the umbrella membrane may be a mesh membrane or mesh membrane to further provide low pressure interval compression. In addition, the outer perimeter of the umbrella membrane may also extend beyond the ends of the main ribs to provide soft edge protection.
According to one embodiment of the invention, the cylindrical stent may also be overcoated or attached with a medical polymer or biomaterial film to reduce irritation to the esophagus. In this case, the umbrella membrane and the cylindrical support membrane may be formed integrally into an elastic membrane or an elastic mesh membrane for easy assembly (simply fitting).
According to an embodiment of the present invention, the main rib may be formed in a flat strip shape and a plurality of perforations are formed thereon, so that the low pressure interval compression effect can be further improved.
Compared with the common hemostatic devices with non-adjustable local pressure such as three-cavity two-sac tube, the device can obviously increase the compression area of the gastric fundus, can provide low-pressure interval compression, can ensure the blood supply of esophagus and gastric fundus compression mucous membrane, and does not cause mucous membrane necrosis; after the device is placed, the gastroscopy can be further carried out through the esophageal stent and the hollow passage of the fundus umbrella, so that diagnosis and treatment possibility are provided for hemostasis under the gastroscope and hemostasis of bleeding points outside pressed parts; the placement and the taking out are convenient, and the shape of the memory alloy can be influenced by temperature when the memory alloy needs to be taken out (for example, a patient drinks hot water at 40 ℃ to 60 ℃ to restore the memory alloy material to the original shape) so as to facilitate the taking out; the observation during the placement is simple, the related complications of the three-cavity two-bag tube can be obviously reduced, and particularly, the bleeding complications after the three-cavity two-bag tube is torn off when the three-cavity two-bag tube is taken out can be avoided; the device can be placed for a long time, can provide long-term compression treatment besides acute-phase treatment, can be used for the preventive treatment of bleeding of patients with severe varicose veins of esophagus and stomach fundus, and expands treatment indications.
Drawings
FIG. 1 is a schematic view of a simple structure in the vicinity of the fundus of the human digestive tract;
FIG. 2 is a schematic view of the medical body cavity internal pressure applicator of the present invention in an open or operative condition; and
fig. 3 is a schematic view showing a closed or pre-use state of the medical body cavity internal pressure applying device of the present invention.
Detailed Description
The invention is further described below with reference to the accompanying drawings. It will be appreciated by those skilled in the art that the embodiments described below are merely illustrative of the present invention and are not intended to be limiting in any way. For example, while the present invention has been described with respect to compression hemostasis of the fundus of the digestive tract, it will be apparent that it may be used in other suitable locations or applications.
As shown in fig. 2, the medical body cavity internal pressure applying device of the present invention includes a cylindrical holder 3 and an openable and closable umbrella 5, and a connection transition portion 4 therebetween.
The tubular stent 3 is generally cylindrical in outer profile, formed with a hollow channel and radially expandable. The cylindrical stent 3 is preferably made of an elastic material such as a shape memory alloy elastic material. In addition, the illustrated cylindrical holder 3 is formed in a net cylinder structure, so that low-pressure interval compression can be provided.
The openable and closable umbrella 5 has an upper umbrella tip and a lower openable and closable end. The top end of the umbrella is provided with an opening and is communicated with the hollow channel of the cylindrical bracket 3 through the hollow connecting transition part 4. When the tubular stent 3 is in the expanded state, the outer diameter of the connection transition section 4 is smaller than the outer diameter of the tubular stent. The connection transition 4 is illustrated as being shaped like a truncated cone with its tapered end facing the tip of the umbrella 3.
The openable and closable umbrella 5 includes a plurality of main ribs 9, a plurality of first branch ribs 7, a plurality of second branch ribs 8, and a fixing rod 6.
The main rib 9 converges toward the top end of the openable and closable umbrella 5 in the opened state of the openable and closable umbrella. The main rib 9 may be made of a suitable material such as titanium or may be made of a shape memory alloy elastic material. The main rib 9 may be formed in a flat strip shape. A plurality of perforations may be further formed in the flat, elongated main rib 9. The length of the main rib 9 can be about 9 cm.
An umbrella cover or an umbrella film 10 is attached to the main rib 9, and the umbrella film 10 can be made of medical polymer materials or human body absorbable and degradable materials. Although not shown, the umbrella membrane 10 can also employ a mesh or mesh membrane to further provide low pressure interval compression. The outer periphery of the canopy 10 may extend slightly beyond the ends of the main ribs 9 to provide soft edge protection.
In addition, the tubular stent 3 may be coated or attached with a medical polymer or biomaterial film (not shown) to reduce irritation to the esophagus 50. In this case, the umbrella film 10 may be integrally formed with the tubular holder film as an elastic film or an elastic mesh film.
The illustrated fixing bar 6 has an upper first end arranged adjacent to the umbrella tip of the openable and closable umbrella 5 and a lower second end arranged adjacent to the open and closed end of the openable and closable umbrella 5. The length of the fixing rod 6 may be about 5 cm.
Each first branch rib 7 has a proximal end fixedly connected to the first end of the fixing rod 6 and a distal end extending towards the top end of the umbrella and fixedly connected to the corresponding main rib 9. Thus, the fixing rod 6 and the main rib 9 are fixed to each other by the first branch rib 7. The first branch rib 7 may be formed in a round bar shape, and the length may be about 4 cm.
Each second branch rib 8 also has a proximal end and a distal end, the proximal end of which is longitudinally slidably connected to the second end of the fixing rod 6 and the distal end extends towards the top end of the umbrella and is fixedly connected to the corresponding main rib 9. The second branch rib 8 may be formed in a round bar shape, and the length may be about 6 cm. Both the first branch rib 7 and the second branch rib 8 can be made of shape memory alloy elastic materials.
The connection point of the first branch rib 7 and the main rib 9 is closer to the top end of the umbrella than the connection point of the second branch rib 8 and the main rib 9, so that the connection point of the first branch rib 7 forms a first inner ring and the connection point of the second branch rib 8 forms a second outer ring. An included angle of about 40 degrees can be formed between the first branch umbrella rib 7 and the fixed rod.
A plurality of longitudinal runners (not specifically shown) are circumferentially spaced around the second end of the securing rod 6 to receive the proximal end of a corresponding second branch rib 8. A series of stop mechanisms, such as slot diameter constrictions 12, may be provided longitudinally (up and down in the illustration) on each runner to stop the proximal end of the second branch rib 8 sliding thereto. The proximal end of the second branch rib 8 may in this case preferably be formed as an expansion head structure, such as a half ball head. The longitudinal sliding grooves are preferably provided as blind grooves formed on the circumferential wall of the solid fixing bar 6 in order to avoid entanglement between the adjustment wires 1, which will be described below.
In order to facilitate the adjustment of the longitudinal sliding of the proximal end of the second branch rib 8 along the fixing rod 6, a plurality of adjustment wires 1 may be used, wherein one end of each adjustment wire 1 is connected with the proximal end of the second branch rib 8, and the other end extends out of the opening of the top end of the openable and closable umbrella 5 and the hollow channel of the tubular bracket 3. In order to prevent scattering of the adjustment wires 1 and possible damage to the digestive tract, a large part of these adjustment wires 1 (referred to as their length) may be accommodated in a hose 11.
As shown in fig. 3, the medical body cavity internal pressure applying device of the present invention may further include a removable sleeve or a removable cartridge 2 which is externally fitted over the openable and closable umbrella 5 and the cylindrical holder 3 to be maintained in a closed state or a contracted state, and automatically releases the openable and closable umbrella 5 and the cylindrical holder 3 to be brought into an open state or an expanded state after being removed. Those skilled in the art will appreciate that any other suitable means may be employed to release the umbrella 5 and the barrel 3 to an open or expanded condition.
The use and operation of the medical body cavity internal pressure applicator of the present invention in the vicinity of the fundus of the digestive tract is briefly described below.
Firstly, the device with the sleeve 2 is delivered to the vicinity of the fundus 60 of the alimentary canal through the oral cavity or the nasal cavity, the sleeve 2 is extracted after the position is determined through the ultrasonic wave at the side of the x-ray or the bed, at the moment, the tubular bracket 3 and the openable and closable umbrella 5 are automatically expanded or normally opened, the whole device is clamped or positioned at the corresponding positions of the esophagus 50 and the fundus 60 due to the relatively reduced outer diameter of the connecting transition part 4, and the varicose veins at the position are pressurized to stop bleeding. Since the entire device is formed with hollow channels running up and down, other examinations such as gastroscopy can still be performed at this time. In addition, the hemostatic device of the present invention may even be subsequently left in the patient for a short period of time to maintain its hemostatic effect without affecting its normal life.
If the pressure applied by the adjusting device to a place near the fundus of the stomach is needed, the corresponding adjusting wire 1 is pulled upwards, so that the proximal end of the second branch rib 8 connected with the adjusting wire is driven to slide upwards along the longitudinal sliding groove arranged on the outer circumference of the fixed rod 6 until the groove diameter narrowing part 12 at the height corresponding to the needed pressure is stopped at the groove diameter narrowing part.
In addition, the pressure of a plurality of directions around the umbrella surface of the openable umbrella 5 can be respectively adjusted by sequentially adjusting different adjusting wires 1, so that the curved vein of the whole umbrella surface on the surface of the gastric fundus mucosa is approximately and completely attached and pressed, and the full hemostasis effect is achieved.

Claims (7)

1. A medical body cavity internal pressure applying apparatus comprising an openable and closable pressure applying umbrella having an umbrella tip and an open-close end, the pressure applying umbrella comprising:
a plurality of main ribs converging toward an umbrella tip of the pressing umbrella in an opened state of the pressing umbrella;
umbrella membranes attached to the plurality of main ribs;
a stationary bar having a first end and a second end, wherein the first end of the stationary bar is disposed adjacent an umbrella tip of the pressure umbrella and the second end of the stationary bar is disposed adjacent an open and closed end of the pressure umbrella;
a plurality of first branch ribs, each first branch rib having a proximal end and a distal end, wherein the proximal end of each first branch rib is fixedly connected to the first end of the fixation rod and the distal end extends toward the top end of the umbrella and is fixedly connected to the corresponding main rib;
a plurality of second branch ribs, each second branch rib having a proximal end and a distal end, wherein the proximal end of each second branch rib is connected to the second end of the fixing rod and the distal end extends toward the umbrella tip and is fixedly connected to the corresponding main rib, the first branch rib and the second branch rib are made of an elastic material, the connection point of the first branch rib and the main rib is more adjacent to the umbrella tip than the connection point of the second branch rib and the main rib, and the umbrella tip is formed with an opening; and
a plurality of adjusting wires, each adjusting wire is connected with the proximal end of the second branch rib and extends out of the opening at the top end of the pressure applying umbrella,
wherein the proximal end of each second branch rib is longitudinally slidably connected to the second end of the fixing rod,
wherein a plurality of longitudinal sliding grooves are arranged near the second end of the fixed rod at intervals along the circumferential direction so as to receive corresponding second branch umbrella ribs.
2. The medical body cavity internal pressure applying device according to claim 1, further comprising a radially expandable cylindrical support formed with a hollow passage, the cylindrical support being connected to the umbrella tip of the pressure applying umbrella such that the hollow passage of the cylindrical support communicates with the opening of the umbrella tip of the pressure applying umbrella.
3. The medical body cavity internal pressure applying device according to claim 1, wherein there is a connection transition between the cylindrical stent and the tip of the pressure applying umbrella, the connection transition having an outer diameter smaller than that of the cylindrical stent when the cylindrical stent is in the expanded state.
4. The medical body cavity internal pressure applying device according to claim 3, wherein the connecting transition portion is a truncated cone portion having a tapered end directed toward an umbrella tip of the pressure applying umbrella.
5. The medical body cavity internal pressure applying device according to claim 1 or 2, further comprising a removable cartridge which is externally attached to the pressure applying umbrella and/or the cylindrical support so as to be maintained in a closed state or a contracted state, and which automatically releases the pressure applying umbrella and/or the cylindrical support after being removed so as to be brought into an open state or an expanded state.
6. The medical body cavity internal pressure applying device according to claim 1 or 2, wherein the first branch rib, the second branch rib and/or the cylindrical support are at least partially made of a shape memory alloy material, so that the pressure applying umbrella and/or the cylindrical support can be restored to the closed state or the contracted state by changing the temperature.
7. The medical body cavity internal pressure applying device according to claim 1, wherein the umbrella membrane is made of a medical polymer material.
CN201611181112.7A 2016-12-19 2016-12-19 Medical body cavity internal pressure applying device Active CN106580387B (en)

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CN117338496B (en) * 2023-12-04 2024-02-09 北京久事神康医疗科技有限公司 Drug stent conveying device

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JPH0788114A (en) * 1993-09-22 1995-04-04 Igaki Iryo Sekkei:Kk Pricking section closing material
CN1470220A (en) * 2003-06-19 2004-01-28 山东省立医院 Compression hemostasis device for gullet and fundus of stomach
CN2836751Y (en) * 2005-05-24 2006-11-15 刘书盈 The unidirectional embolization device of bronchus under the branchofiberoscope
DE102009046728A1 (en) * 2009-11-16 2011-05-19 Herbert Maslanka Instrument for endoscopically applying e.g. hemostatic agent in gel or gelatine matrix on body tissue surface to endoscopically stop bleeding for treating gastric ulcer, has shield with peripheral edge enclosing chamber in working position
CN201969172U (en) * 2011-01-20 2011-09-14 宗坚 Double-airbag casing pipe used for treatment under gastrointestinal endoscope

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US9398969B2 (en) * 2010-10-19 2016-07-26 Apollo Endosurgery, Inc. Upper stomach gastric implants

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Publication number Priority date Publication date Assignee Title
JPH0788114A (en) * 1993-09-22 1995-04-04 Igaki Iryo Sekkei:Kk Pricking section closing material
CN1470220A (en) * 2003-06-19 2004-01-28 山东省立医院 Compression hemostasis device for gullet and fundus of stomach
CN2836751Y (en) * 2005-05-24 2006-11-15 刘书盈 The unidirectional embolization device of bronchus under the branchofiberoscope
DE102009046728A1 (en) * 2009-11-16 2011-05-19 Herbert Maslanka Instrument for endoscopically applying e.g. hemostatic agent in gel or gelatine matrix on body tissue surface to endoscopically stop bleeding for treating gastric ulcer, has shield with peripheral edge enclosing chamber in working position
CN201969172U (en) * 2011-01-20 2011-09-14 宗坚 Double-airbag casing pipe used for treatment under gastrointestinal endoscope

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