CN106621005B - A kind of manufacturing method of the reinforced segmental epidural catheter of flexibility - Google Patents
A kind of manufacturing method of the reinforced segmental epidural catheter of flexibility Download PDFInfo
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- CN106621005B CN106621005B CN201611226104.XA CN201611226104A CN106621005B CN 106621005 B CN106621005 B CN 106621005B CN 201611226104 A CN201611226104 A CN 201611226104A CN 106621005 B CN106621005 B CN 106621005B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
- A61M25/0053—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0009—Making of catheters or other medical or surgical tubes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0009—Making of catheters or other medical or surgical tubes
- A61M25/0012—Making of catheters or other medical or surgical tubes with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0009—Making of catheters or other medical or surgical tubes
- A61M25/0013—Weakening parts of a catheter tubing, e.g. by making cuts in the tube or reducing thickness of a layer at one point to adjust the flexibility
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0009—Making of catheters or other medical or surgical tubes
- A61M25/0015—Making lateral openings in a catheter tube, e.g. holes, slits, ports, piercings of guidewire ports; Methods for processing the holes, e.g. smoothing the edges
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
- A61M25/0026—Multi-lumen catheters with stationary elements
- A61M25/0032—Multi-lumen catheters with stationary elements characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
- A61M25/007—Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M2025/0007—Epidural catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M2025/0056—Catheters; Hollow probes characterised by structural features provided with an antibacterial agent, e.g. by coating, residing in the polymer matrix or releasing an agent out of a reservoir
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/008—Strength or flexibility characteristics of the catheter tip
- A61M2025/0081—Soft tip
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- Engineering & Computer Science (AREA)
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- Heart & Thoracic Surgery (AREA)
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Abstract
The invention discloses a kind of reinforced segmental epidural catheter of flexibility and its manufacturing methods, wherein the reinforced segmental epidural catheter of flexibility includes the tube body for water conservancy diversion anesthetic liquid medicine, the feeding opening of the tube body is communicated with medicine outlet, the intracavitary support spring body being further provided with of tube body；One of the tube body is equipped with flexible tip section, and the pliability of the flexible tip section is better than the pliability of the main paragraph of the tube body.The manufacturing approach craft of the reinforced segmental epidural catheter of flexibility rationally, it is strong operability, safe and reliable；It with simple process, is easily mastered, the advantages that production cost is low, high-efficient, reliable in quality.
Description
Technical field
The present invention relates to the field of medical instrument technology, reinforce more particularly to a kind of for the flexible of anesthetic liquid medicine infusion
Type segmental epidural catheter and its manufacturing method.
Background technique
Flexible reinforced segmental epidural catheter is the new product that just new release lists in the market in recent years, is substantially
It is normal in clinic to solve common segmental epidural catheter currently used in the market for a kind of important breakthrough of manufacturing process technology
Phenomena such as conduit often occurred is easy to puncture endorchis, is strayed into cavum subarachnoidale, gives a discount causes operation patients body spinal analgesia occur, cut
The security hidden troubles such as paralysis, extradural hemorrhage, because due to approved and favored by vast clinical expert.
Currently, since the manufacturing technology of flexible reinforced segmental epidural catheter is extremely complex and to precision requirement pole
Height, careless slightly or method is inappropriate to will cause defect in product quality, and then when causing during product clinical use
Often occur conduit rupture, internal support spring steel wire and outer conduit fusion it is insecure occur the draw, de- pipe and can not go and buy Chinese medicine
Security risk.
In view of this, the prior art could be improved and improve.
Summary of the invention
Place in view of above-mentioned deficiencies of the prior art, the purpose of the present invention is to provide a kind of reinforced epidural anesthesias of flexibility
Liquor-saturated conduit and its manufacturing method ensure that it in the reinforced segmental epidural catheter tool of property manufactured using the manufacturing method
There is super soft tip, avoids puncturing endorchis in clinical manipulation or damaging blood vessel etc. causing the clinics such as extradural hemorrhage or hemotoncus
Complication, simultaneously, it is ensured that conduit outer wall plastic layer and " molten " the unification body of pipe inner wall steel wire floor de- pipe, the draw do not occur or lead
" discounting " phenomenon is managed, is guaranteed unblocked when clinical infusion anesthetic liquid medicine.Meanwhile catheter surface is super smooth, reduces doctor and sets
The resistance of pipe ejector sleeve and secondary damage to vascular tissue.
In order to achieve the above object, this invention takes following technical schemes:
A kind of reinforced segmental epidural catheter of flexibility, wherein the reinforced segmental epidural catheter of flexibility includes using
It is communicated in the feeding opening of the tube body of water conservancy diversion anesthetic liquid medicine, the tube body with medicine outlet, the intracavitary support being further provided with of tube body
Spring body；One of the tube body is equipped with flexible tip section, and the pliability of the flexible tip section is better than the main body of the tube body
The pliability of section.
Preferably, the reinforced segmental epidural catheter of flexibility, wherein the circular in cross-section of the tube body is ellipse
Circle, and it is transparent or translucent.
Preferably, the reinforced segmental epidural catheter of flexibility, wherein the support spring body is by stainless steel material
Or nickel-titanium alloy material is made one, support spring body is helical arrangement, and support spring body line footpath is 0.03 mm-
0.18mm；The pitch of loose section of adjacent coil springs circle of the tube body is 0.2 mm-1.0mm, and loose section of length is
10mm-100mm.
Preferably, the reinforced segmental epidural catheter of flexibility, wherein the tube body is set at the rear portion of flexible tip
There is side opening medicine outlet, the tube body front is equipped with scale mark, described convenient for the depth of doctor's accurate perception conduit implantation human body
Tube body leading portion, middle part, rear portion are equipped with loose section and are used as watch window, and whether observe liquid infusion convenient for doctor normal and have
Blood back.
Preferably, the reinforced segmental epidural catheter of flexibility, wherein the number of the side opening medicine outlet is 1 to 3
A, side opening medicine outlet diameter is 0.10mm to 0.80mm.
A kind of manufacturing method of the above-mentioned reinforced segmental epidural catheter of flexibility, wherein the method includes following steps
It is rapid:
S1, the tube body for making TPU material；It further comprises stock, baking material and extruding pipe material；
S2, production support spring body；
S3, tube body and support spring are mentioned and combined.
Preferably, the manufacturing method of the reinforced segmental epidural catheter of flexibility, wherein the step S1 is specifically wrapped
It includes:
S11, thermoplastic polyurethane material is selected, thermoplastic polyurethane material's pellet is dried using drying machine or materal drier
It is dry, remove pellet moisture；Between 80 to 100 degree, drying time is to be advisable 4 to 6 hours for drying temperature control；
S12, required tube body is squeezed out by predefined parameter using plastic cement tube extruding machine, outer tube diameter is set as 0.60 millimeter of -1.90 milli
Rice, interior to be set as 0.30 millimeter -0.90 millimeter, tube length is cut into 1300-1500 millimeters on demand.
Preferably, the manufacturing method of the reinforced segmental epidural catheter of flexibility, wherein the step S2 is specifically wrapped
It includes:
S21, the metal steel wire or Nitinol line for selecting satisfactory 304,316 or MP35N；
S22, the metal steel wire of 304,316 or MP35N or Nitinol line are fabricated to by coiling machine pressure spring technique it is soft
Property helical spring body；The line footpath of spring body is set as 0.03 millimeter -0.18 millimeter, and spring body outer diameter is set as 0.30 millimeter of -0.95 milli
Rice, the length of spring body can be cut according to actual needs；
S23, the flexible pellet spring body made is cleaned into its surface and oil contaminant using supersonic wave cleaning machine, cleaning temperature is taken the photograph for 50
- 80 degrees Celsius of family name's degree, scavenging period minute 5-8 minutes；
S24, the spring body after above-mentioned ultrasonic cleaning is placed on dryer and is toasted -3 hours 2 hours, baking temperature is set
It is 150 degrees Celsius -250 degrees Celsius.
Preferably, the manufacturing method of the reinforced segmental epidural catheter of flexibility, wherein the step S2 is also into one
Step includes:
S25, press preset requirement, three sections of windows before, during and after flexible pellet spring body being issued using at the uniform velocity pulling force molding machine
Mouthful, so that doctor observes anesthetic liquid medicine water conservancy diversion or blood backflow situation in real time；It is soft to conduit implantation human body one end according to clinic
The different of degree require, and preceding see-through window length are set as 30 millimeters -100 millimeters, middle window, rear window length are set as 10 millis
- 30 millimeters of rice.Pitch between window adjacent coil springs circle is uniformly set as 0.2 millimeter -1.0 millimeters.
Preferably, the manufacturing method of the reinforced segmental epidural catheter of flexibility, wherein the step S3 is specifically wrapped
It includes:
S31, the outer solid stainless steel wire through being less than spring intracoelomic cavity is pierced into and is placed in spring intracoelomic cavity to support whole
The hardness of spring body；
S32, it the flexible pellet spring body of window before, during and after above-mentioned issue is pierced into is placed in tube cavity, extraction support
Solid stainless steel wire；
S33, the tube body for having set spring body is stretched round about using specific at the uniform velocity puller system, both ends are fixed on Y type
On bracket, so that the even tube wall of tube body is close to together with the complete outer wall of spring body；
S34, the above-mentioned tube body fixed being placed in specific thermostatic oven baking, baking temperature is set as 100 degree of -190 degree,
Baking time is -25 minutes 15 minutes, and baking number is set as 1 time -2 according to the actual conditions of tube body and the fusion of spring body outer wall
It is secondary, so that the tube wall of tube body is fused completely with spring body and is integrated and fixed-type；
S35, the good conduit of above-mentioned hot melt molding is subjected to scale mark printing with professional pad printer；Wherein, print request
As follows: scale marks for every 1 centimetre one backward from implantation human body one end, and printing length is 25 centimetres in total, and scale wants 360 degree of circles
It is whole full, clearly, there cannot be unfilled corner, alcohol screen test cannot fall paint, and surface cannot be uneven, and end graduation mark covers bullet just
Spring end；
S36, the above-mentioned conduit for printing scale mark is placed on customization baking box and is toasted, 80 degrees Celsius of baking temperature-
Between 150 degrees Celsius, baking time -30 minutes 15 minutes；Conduit is taken out, natural airing takes cotton swab to dip in wet 75% medicinal alcohol and exists
Scraped on scale mark 10 times or more it is no paint-shedding；
S37, one end of above-mentioned conduit implantation human body is subjected to the supple-settlement of tip cambered surface, so that catheter proximal end forms taper,
Resistance when setting pipe is reduced, while conduit leading portion softness is moderate, does not damage epidural vessel and its soft tissue when being placed in human body, really
Protect clinical use safety；The molding at tip is divided to two kinds, and one is directly the processing of tip cambered surface is carried out in catheter tip, another kind is
Tip, which is carried out, using the thermoplastic polyurethane material with developer and existing tube body welds fuse process；
S38, side opening is opened up as medicine outlet using above-mentioned conduit using professional puncher, side opening can open 1 according to actual needs
To 3 side openings, each aperture is 0.30-0.80 millimeters, and distance is 0.40-0.60 millimeters between side opening.The side opening of distalmost end from
End is about 5-8 millimeters；
S39, above-mentioned conduit is placed on professional automated fluid coating apparatus or is soaked in hydrophilic superslide coating solution
Or the processing of catheter surface superslide or anti-infective processing are carried out in the container slot of anti-infective solution, make catheter surface with a layer thickness
About 0.02-0.10 millimeters of specific function outer layer；
S310, it above-mentioned surface treated conduit is placed in professional thermostatic oven carries out Temperature Treatment, solidification is led
The specific function outer layer of pipe surface, heating temperature are set as between 80 to 150 degrees Celsius, and by above-mentioned conduit be placed in ultrasonic wave into
Row cleaning 1 to 2 time, removes catheter surface stain；Clean gas is connected with Highpressure Tee plate again to be followed by above-mentioned conduit emptying leading
Pipe internal residual moisture, while observing whether ventilatory conditions have plugging.
Compared with prior art, the reinforced segmental epidural catheter of flexibility of the invention and its manufacturing method advantage are:
1, this method rational technology, strong operability, securely and reliably
2, simple process is easily mastered, and production cost is low, high-efficient, reliable in quality.
3, tube body one is equipped with the flexible soft tip of taper cambered surface, propelling resistance is reduced when setting pipe, while front end is soft, no
Easy damaged human body soft tissue efficiently reduces injury of the surgical procedure to human body, prevents possible medical-risk.
4, this method use is expanded with heat and contract with cold forming principle, and conduit is fused completely with flexible pellet spring body and is integrated, fusion jail
Gu Resisting fractre, anti-pull, avoid occurring the hair that " conduit and spring are detached from " causes potential medical-risk in conduit use process
It is raw.
Detailed description of the invention
Fig. 1 is the stream of the tube body of production TPU material in the manufacturing method of the flexible reinforced segmental epidural catheter of the present invention
Cheng Tu.
Fig. 2 is the tube body of production support spring body in the manufacturing method of the flexible reinforced segmental epidural catheter of the present invention
Flow chart.
Specific embodiment
The reinforced segmental epidural catheter of flexibility provided by the invention and its manufacturing method.To make the purpose of the present invention, skill
Art scheme and effect are clearer, clear, and the present invention is described in more detail as follows in conjunction with drawings and embodiments.It should manage
Solution, described herein specific examples are only used to explain the present invention, is not intended to limit the present invention.
The present invention provides a kind of reinforced segmental epidural catheters of flexibility, wherein the reinforced epidural anesthesia of flexibility
Liquor-saturated conduit includes the tube body for water conservancy diversion anesthetic liquid medicine, and the feeding opening of the tube body is communicated with medicine outlet, and tube body is intracavitary further
The support spring body being provided with；One of the tube body is equipped with flexible tip section, and the pliability of the flexible tip section is better than institute
State the pliability of the main paragraph of tube body.In the present embodiment, the circular in cross-section or ellipse of the tube body, and it is transparent or
It is translucent.The support spring body is made one by stainless steel material or nickel-titanium alloy material, and support spring body is spiral shell
Shape arrangement is revolved, support spring body line footpath is 0.03 mm-0.18mm；The section of loose section of adjacent coil springs circle of the tube body
Away from for 0.2 mm-1.0mm, loose section of length is 10mm-100mm.The tube body is equipped with side opening at the rear portion of flexible tip
Medicine outlet, the tube body front are equipped with scale mark, convenient for the depth of doctor's accurate perception conduit implantation human body, before the tube body
Section, middle part, rear portion are equipped with loose section and are used as watch window, and whether observe liquid infusion convenient for doctor normal and whether have blood back.
The number of the side opening medicine outlet is 1 to 3, and side opening medicine outlet diameter is 0.10mm to 0.80mm.Flexible reinforcement of the invention
Type segmental epidural catheter has super soft tip, avoids puncturing endorchis in clinical manipulation or damaging blood vessel etc. causing dura mater
The clinical complications such as external hemorrhage or hemotoncus, meanwhile, conduit outer wall plastic layer and " molten " the unification body of pipe inner wall steel wire floor do not occur
De- pipe, the draw or conduit " discounting " phenomenon guarantee unblocked when clinical infusion anesthetic liquid medicine.Meanwhile the super light of catheter surface
It is sliding, it reduces doctor and sets the resistance of pipe ejector sleeve and the secondary damage to vascular tissue.
The production method for highlighting down the above-mentioned reinforced segmental epidural catheter of flexibility below, mainly includes three
Step:
S1, the tube body for making TPU material；It further comprises stock, baking material and extruding pipe material；
S2, production support spring body；
S3, tube body and support spring are mentioned and combined.
Referring to Fig. 1, the step S1 is specifically wrapped in the manufacturing method of the reinforced segmental epidural catheter of flexibility
It includes:
S11, thermoplastic polyurethane material (TPU) is selected, using drying machine or materal drier thermoplastic polyurethane material's grain
Material drying, removes pellet moisture；Between 80 to 100 degree, drying time is to be advisable 4 to 6 hours for drying temperature control；
S12, required tube body is squeezed out by predefined parameter using plastic cement tube extruding machine, outer tube diameter is set as 0.60 millimeter of -1.90 milli
Rice, interior to be set as 0.30 millimeter -0.90 millimeter, tube length is cut into 1300-1500 millimeters on demand.
Further, the manufacturing method of the reinforced segmental epidural catheter of flexibility, as shown in Fig. 2, the step
S2 is specifically included:
S21, the metal steel wire or Nitinol line for selecting 304,316 or MP35N；
S22, the metal steel wire of 304,316 or MP35N or Nitinol line are fabricated to by coiling machine pressure spring technique it is soft
Property helical spring body；The line footpath of spring body is set as 0.03 millimeter -0.18 millimeter, and spring body outer diameter is set as 0.30 millimeter of -0.95 milli
Rice, the length of spring body can be cut according to actual needs；
S23, the flexible pellet spring body made is cleaned into its surface and oil contaminant using supersonic wave cleaning machine, cleaning temperature is taken the photograph for 50
- 80 degrees Celsius of family name's degree, scavenging period minute 5-8 minutes；
S24, the spring body after above-mentioned ultrasonic cleaning is placed on dryer and is toasted -3 hours 2 hours, baking temperature is set
It is 150 degrees Celsius -250 degrees Celsius.
Preferably, in the manufacturing method of the reinforced segmental epidural catheter of flexibility, the step S2 is also further
Include:
S25, press preset requirement, three sections of windows before, during and after flexible pellet spring body being issued using at the uniform velocity pulling force molding machine
Mouthful, so that doctor observes anesthetic liquid medicine water conservancy diversion or blood backflow situation in real time；It is soft to conduit implantation human body one end according to clinic
The different of degree require, and preceding see-through window length are set as 30 millimeters -100 millimeters, middle window, rear window length are set as 10 millis
- 30 millimeters of rice.Pitch between window adjacent coil springs circle is uniformly set as 0.2 millimeter -1.0 millimeters.
Further, the manufacturing method of the reinforced segmental epidural catheter of flexibility, the step S3 are specifically included:
S31, the outer solid stainless steel wire through being less than spring intracoelomic cavity is pierced into and is placed in spring intracoelomic cavity to support whole
The hardness of spring body；
S32, it the flexible pellet spring body of window before, during and after above-mentioned issue is pierced into is placed in tube cavity, extraction support
Solid stainless steel wire；
S33, the tube body for having set spring body is stretched round about using specific at the uniform velocity puller system, both ends are fixed on Y type
On bracket, so that the even tube wall of tube body is close to together with the complete outer wall of spring body；
S34, the above-mentioned tube body fixed being placed in specific thermostatic oven baking, baking temperature is set as 100 degree of -190 degree,
Baking time is -25 minutes 15 minutes, and baking number is set as 1 time -2 according to the actual conditions of tube body and the fusion of spring body outer wall
It is secondary, so that the tube wall of tube body is fused completely with spring body and is integrated and fixed-type；
S35, the good conduit of above-mentioned hot melt molding is subjected to scale mark printing with professional pad printer；Wherein, print request
As follows: scale marks for every 1 centimetre one backward from implantation human body one end, and printing length is 25 centimetres in total, and scale wants 360 degree of circles
It is whole full, clearly, there cannot be unfilled corner, alcohol screen test cannot fall paint, and surface cannot be uneven, and end graduation mark covers bullet just
Spring end；
S36, the above-mentioned conduit for printing scale mark is placed on customization baking box and is toasted, 80 degrees Celsius of baking temperature-
Between 150 degrees Celsius, baking time -30 minutes 15 minutes；Conduit is taken out, natural airing takes cotton swab to dip in wet 75% medicinal alcohol and exists
Scraped on scale mark 10 times or more it is no paint-shedding；
S37, one end of above-mentioned conduit implantation human body is subjected to the supple-settlement of tip cambered surface, so that catheter proximal end forms taper,
Resistance when setting pipe is reduced, while conduit leading portion softness is moderate, does not damage epidural vessel and its soft tissue when being placed in human body, really
Protect clinical use safety；The molding at tip is divided to two kinds, and one is directly the processing of tip cambered surface is carried out in catheter tip, another kind is
Tip, which is carried out, using the thermoplastic polyurethane material with developer and existing tube body welds fuse process；
S38, side opening is opened up as medicine outlet using above-mentioned conduit using professional puncher, side opening can open 1 according to actual needs
To 3 side openings, each aperture is 0.30-0.80 millimeters, and distance is 0.40-0.60 millimeters between side opening.The side opening of distalmost end from
End is about 5-8 millimeters；
S39, above-mentioned conduit is placed on professional automated fluid coating apparatus or is soaked in hydrophilic superslide coating solution
Or the processing of catheter surface superslide or anti-infective processing are carried out in the container slot of anti-infective solution, make catheter surface with a layer thickness
About 0.02-0.10 millimeters of specific function outer layer；
S310, it above-mentioned surface treated conduit is placed in professional thermostatic oven carries out Temperature Treatment, solidification is led
The specific function outer layer of pipe surface, heating temperature are set as between 80 to 150 degrees Celsius, and by above-mentioned conduit be placed in ultrasonic wave into
Row cleaning 1 to 2 time, removes catheter surface stain；Clean gas is connected with Highpressure Tee plate again to be followed by above-mentioned conduit emptying leading
Pipe internal residual moisture, while observing whether ventilatory conditions have plugging.
Finally, above-mentioned conduit is placed in professional drying box heating so that volume drying inside and outside conduit, according to practical need
It asks and conduit is packed.
In conclusion the reinforced segmental epidural catheter of flexibility provided by the invention and its manufacturing method, wherein described soft
The reinforced segmental epidural catheter of property includes the tube body for water conservancy diversion anesthetic liquid medicine, feeding opening and the medicine outlet phase of the tube body
It is logical, the intracavitary support spring body being further provided with of tube body；One of the tube body is equipped with flexible tip section, the flexible tip
Pliability of the pliability of section better than the main paragraph of the tube body.The manufacturing method of the reinforced segmental epidural catheter of flexibility
It is rational technology, strong operability, safe and reliable；It with simple process, is easily mastered, production cost is low, high-efficient, reliable in quality
The advantages that.
It, can according to the technique and scheme of the present invention and its hair it is understood that for those of ordinary skills
Bright design is subject to equivalent substitution or change, and all these changes or replacement all should belong to the guarantor of appended claims of the invention
Protect range.
Claims (4)
1. a kind of manufacturing method of the reinforced segmental epidural catheter of flexibility, which is characterized in that the described method comprises the following steps:
S1, the tube body for making TPU material；It further comprises stock, baking material and extruding pipe material；
S2, production support spring body；
S3, tube body and support spring body are combined；
The step S1 is specifically included:
S11, thermoplastic polyurethane material is selected, thermoplastic polyurethane material's pellet is dried using drying machine or materal drier, is removed
Remove pellet moisture；Between 80 to 100 degree, drying time is 4 to 6 hours for drying temperature control；
S12, squeezed out using plastic cement tube extruding machine by predefined parameter needed for tube body, outer tube diameter is set as 0.60 millimeter -1.90 millimeters, interior
Diameter is set as 0.30 millimeter -0.90 millimeter, and tube length is cut into 1300-1500 millimeters；
The step S3 is specifically included:
S31, the solid stainless steel wire that outer diameter is less than spring intracoelomic cavity is pierced into and is placed in spring intracoelomic cavity to support whole spring
The hardness of body；
S32, will issue before, during and after the flexible pellet spring body of window pierce into and be placed in tube cavity, extraction support is solid stainless
Steel wire；
S33, the tube body for having set spring body is stretched round about using specific at the uniform velocity puller system, both ends are fixed on Y type bracket
On, so that the even tube wall of tube body is close to together with spring body outer wall；
S34, above-mentioned fix is close to tube body together and is placed in specific thermostatic oven toast, baking temperature be set as 100 degree-
190 degree, baking time is -25 minutes 15 minutes, and baking number is set as 1 time -2 times, so that the tube wall of tube body and spring body are complete
Fusion is integrated and fixed-type.
2. the manufacturing method of the reinforced segmental epidural catheter of flexibility according to claim 1, which is characterized in that the step
Rapid S2 is specifically included:
S21, the metal steel wire or Nitinol line for selecting 304,316 or MP35N；
S22, the metal steel wire of 304,316 or MP35N or Nitinol line are fabricated to flexible spiral shell by coiling machine pressure spring technique
Revolve spring body；The line footpath of spring body is set as 0.03 millimeter -0.18 millimeter, and spring body outer diameter is set as 0.30 millimeter -0.95 millimeter, will
Spring body is cut into predetermined length；
S23, the flexible pellet spring body made is cleaned into its surface and oil contaminant using supersonic wave cleaning machine, cleaning temperature is 50 Celsius
- 80 degrees Celsius, scavenging period minute 5-8 minutes of degree；
S24, the spring body after above-mentioned ultrasonic cleaning is placed on dryer and is toasted -3 hours 2 hours, baking temperature is set as 150
Degrees Celsius -250 degrees Celsius.
3. the manufacturing method of the reinforced segmental epidural catheter of flexibility according to claim 1, which is characterized in that the step
Rapid S2 may further comprise:
S25, press preset requirement, three sections of see-through windows before, during and after being issued flexible pellet spring body using at the uniform velocity pulling force molding machine, with
Just doctor observes anesthetic liquid medicine water conservancy diversion or blood backflow situation in real time；Preceding see-through window length is set as 30 millimeters -100 millimeters,
Middle window, rear window length are set as 10 millimeters -30 millimeters, and the pitch between window adjacent coil springs circle is uniformly set as
0.2 millimeter -1.0 millimeters.
4. the manufacturing method of the reinforced segmental epidural catheter of flexibility according to claim 1, which is characterized in that the step
Rapid S3 further include:
S35, it tube wall in S34 and spring body fuse is completely integrated and fixed-type conduit with profession pad printer carries out scale
Label print；Wherein, print request is as follows: scale marks for every 1 centimetre one backward from implantation human body one end, in total printing length
Be 25 centimetres, scale wants 360 degree of roundings full, clearly, cannot there is a unfilled corner, and alcohol screen test cannot fall paint, surface cannot it is concave-convex not
Flat, one end graduation mark far from implantation human body covers the one end of spring body far from implantation human body just；
S36, the above-mentioned conduit for printing scale mark is placed on customization baking box and is toasted, 80 degree Celsius -150 of baking temperature is taken the photograph
Between family name's degree, baking time -30 minutes 15 minutes；Conduit is taken out, natural airing takes cotton swab to dip in wet 75% medicinal alcohol in scale
Scraped on label 10 times or more it is no paint-shedding；
S37, one end of above-mentioned conduit implantation human body is subjected to the supple-settlement of tip cambered surface, so that catheter proximal end forms taper, reduced
Resistance when pipe is set, while conduit leading portion is soft, does not damage epidural vessel and its soft tissue when being placed in human body, it is ensured that clinic makes
With safety；The molding at tip is divided to two kinds, and selectable, one is directly carry out at the cambered surface of tip in one end of conduit implantation human body
Reason, another kind are that welding fuse process in tip is carried out using the thermoplastic polyurethane material with developer and existing tube body；
S38, side opening is opened up as medicine outlet using above-mentioned conduit using professional puncher, side opening opens 1 to 3 side openings, each aperture
It is 0.30-0.80 millimeters, distance is 0.40-0.60 millimeters between side opening, and the one end of side opening from implantation human body of distalmost end is about
5-8 millimeters；
S39, above-mentioned conduit is placed on professional automated fluid coating apparatus or is soaked in hydrophilic superslide coating solution or resisted
It infects and carries out the processing of catheter surface superslide or anti-infective processing in the container slot of solution, catheter surface is made to have a layer thickness about
0.02-0.10 millimeters of specific function outer layer；
S310, it above-mentioned surface treated conduit is placed in professional thermostatic oven carries out Temperature Treatment, solidify conduit table
The specific function outer layer in face, heating temperature are set as between 80 to 150 degrees Celsius, and above-mentioned conduit is placed in ultrasonic wave and is carried out clearly
It washes 1 to 2 time, removes catheter surface stain；Clean gas is connected with Highpressure Tee plate again to be followed by above-mentioned conduit emptying conduit
Portion's residual moisture, while observing whether ventilatory conditions have plugging.
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| CN113797422A (en) * | 2020-06-13 | 2021-12-17 | 河南驼人医疗器械集团有限公司 | Preparation method of steel wire anesthesia catheter |
| CN114602034A (en) * | 2022-03-10 | 2022-06-10 | 广东益德医疗科技有限公司 | Steel wire type flexible reinforced epidural anesthesia catheter and manufacturing process thereof |
Citations (5)
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|---|---|---|---|---|
| CN1554687A (en) * | 2003-12-26 | 2004-12-15 | 华南理工大学 | Hydrophilic thermoplastic polyurethane elastomer and its preparing method and use |
| CN202740586U (en) * | 2012-06-27 | 2013-02-20 | 江苏省华星医疗器械实业有限公司 | Non-destructive soft-headed anesthetic catheter |
| CN202982872U (en) * | 2012-12-29 | 2013-06-12 | 陈世斌 | Epidural anesthesia catheter |
| CN104014067A (en) * | 2013-03-01 | 2014-09-03 | 陈世斌 | Medical guiding wire with insulating coating layer and manufacturing method of medical guiding wire |
| CN105147336A (en) * | 2015-10-28 | 2015-12-16 | 上海爱声生物医疗科技有限公司 | Intravascular ultrasound catheter and rapid forming method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA2726418A1 (en) * | 2010-01-12 | 2011-07-12 | Custom Medical Applications, Inc. | Ultrasound guided echogenic catheter and related methods |
| JP6525873B2 (en) * | 2012-08-23 | 2019-06-05 | ボルケーノ コーポレイション | Apparatus, system and method for anatomical wound length estimation |
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- 2016-12-27 CN CN201611226104.XA patent/CN106621005B/en active Active
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1554687A (en) * | 2003-12-26 | 2004-12-15 | 华南理工大学 | Hydrophilic thermoplastic polyurethane elastomer and its preparing method and use |
| CN202740586U (en) * | 2012-06-27 | 2013-02-20 | 江苏省华星医疗器械实业有限公司 | Non-destructive soft-headed anesthetic catheter |
| CN202982872U (en) * | 2012-12-29 | 2013-06-12 | 陈世斌 | Epidural anesthesia catheter |
| CN104014067A (en) * | 2013-03-01 | 2014-09-03 | 陈世斌 | Medical guiding wire with insulating coating layer and manufacturing method of medical guiding wire |
| CN105147336A (en) * | 2015-10-28 | 2015-12-16 | 上海爱声生物医疗科技有限公司 | Intravascular ultrasound catheter and rapid forming method thereof |
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