WO2018120982A1 - 一种双层引流管 - Google Patents

一种双层引流管 Download PDF

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Publication number
WO2018120982A1
WO2018120982A1 PCT/CN2017/105627 CN2017105627W WO2018120982A1 WO 2018120982 A1 WO2018120982 A1 WO 2018120982A1 CN 2017105627 W CN2017105627 W CN 2017105627W WO 2018120982 A1 WO2018120982 A1 WO 2018120982A1
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WIPO (PCT)
Prior art keywords
drainage tube
layer
drainage
outer layer
tube
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PCT/CN2017/105627
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English (en)
French (fr)
Inventor
郑忠伟
龚彪
袁庆
王攀
严航
Original Assignee
上海英诺伟医疗器械有限公司
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Application filed by 上海英诺伟医疗器械有限公司 filed Critical 上海英诺伟医疗器械有限公司
Priority to US16/473,178 priority Critical patent/US20190314618A1/en
Priority to EP17888214.8A priority patent/EP3560540A4/en
Priority to JP2019555530A priority patent/JP2020505187A/ja
Publication of WO2018120982A1 publication Critical patent/WO2018120982A1/zh

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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
    • A61M27/00—Drainage appliance for wounds or the like, i.e. wound drains, implanted drains
    • A61M27/002—Implant devices for drainage of body fluids from one part of the body to another
    • 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
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
    • A61L29/16—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/04—Macromolecular materials
    • A61L29/041—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/04—Macromolecular materials
    • A61L29/049—Mixtures of macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/04—Macromolecular materials
    • A61L29/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/08—Materials for coatings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/08—Materials for coatings
    • A61L29/085—Macromolecular materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
    • 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
    • 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
    • A61M2025/0008—Catheters; Hollow probes having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
    • 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/10—Trunk
    • A61M2210/1042—Alimentary tract
    • A61M2210/1075—Gall bladder
    • 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

Definitions

  • the invention relates to the field of medical device technology, in particular to a double-layer drainage tube.
  • duodenoscopy has become an important measure for the treatment of hepatobiliary and pancreatic diseases, including common bile duct stones, bile duct injury, bile duct stricture, and biliary complications after liver transplantation. Wait.
  • the contents of duodenoscopy include: endoscopic retrograde cholangiopancreatography (ERCP) and therapeutic ERCP.
  • Therapeutic ERCP includes endoscopic sphencterotomy (EST), endoscopic biliary drainage (EBD), endoscopic nose biliaty drainage (ENBD), Endoscopic retrograde pancreatodrainage (ERPD) and corresponding endoscopic sputum surgery.
  • endoscopic biliary drainage is a bile duct because of its minimal trauma, less complications, and reproducibility compared with conventional techniques.
  • the preferred drainage option has been approved by most clinicians.
  • Body duct drainage tube also known as “biliary tube drainage tube”
  • biliary tube drainage tube is mainly used for endoscopic biliary stone surgery and endoscopic gallbladder removal for bile drainage, and is used with duodenal endoscopy, by inserting an indwelling drainage tube Temporary bile drainage. It is a simple and effective method for relieving obstruction. It is mainly used for postoperative yellowing of benign and malignant biliary obstruction, diagnosis and treatment of suppurative cholangitis, and other diseases requiring bile duct drainage.
  • a variety of plastic drainage tubes and metal drainage tubes have been used in the prior art for bile duct drainage. Compared to metal drainage tubes, plastic drainage tubes are less expensive, more distorted, and easier to insert. However, both plastic drainage tubes and metal drainage tubes are prone to blockage, have poor biocompatibility, and have insufficient strength to insert into the bile duct or cause inflammation.
  • T-type combined biliary drainage tube is disclosed in Reference 1 (CN2531802Y), the main part of which is made of polyvinyl chloride or latex or silicone material.
  • the T-shaped tee is special in that the long arm of the T-shaped tube is covered with a film made of natural red rubber material. The short arms of the drainage tube are left in the abdominal cavity during the surgical procedure.
  • Polyvinyl chloride or latex or silica gel material is less reactive to biliary tissue, can avoid adverse effects on the biliary tract, does not cause excessive inflammatory reactions, and is long through the drainage tube A tissue-reactive natural red rubber film on the surface of the arm that enables early formation of the abdominal sinus in the abdominal cavity to achieve early extubation.
  • Reference 2 (CN1843516A) is further improved on the basis of reference 1, which only needs to provide a composite layer different from the outer surface layer of the stent body or the stent in the outer surface of one arm of the T-shaped drainage tube holder body. It can realize the two-arm outer surface layer of the T-shaped drainage tube stent body which is indwelled and in vivo during surgery, which has good compatibility with the body tissue, less damage to the biliary tract, and relatively poor compatibility with the body tissue, which can quickly stimulate drainage. A good effect of forming a sinus around the tube.
  • the above references are all related to the T-type drainage tube, which is mainly used for biliary incision surgery. It is necessary to ensure the formation and stability of the sinus as much as possible on the basis of ensuring the biocompatibility of the T-tube and the body. Extubation. However, the drainage tube used in ERCP surgery does not need to consider the problem of sinus formation, and the biocompatibility of the polyvinyl chloride material used is poor, causing damage to the body, causing complications such as inflammation and hyperplasia.
  • a bonding layer for a surface coating of a medical device is disclosed in Reference 3 (CN1250382A) by coating a surface of a medical device such as a draft tube with a thin polymer layer of a suitable composition to coat the surface of the substrate with the surface of the substrate A good bond is provided so that the subsequent coating can be firmly bonded to the thin polymer layer and the device is then coated with other layers designed to enhance the performance and biocompatibility of the medical device.
  • the coating may comprise: a drug coating that acts as a surface reservoir for the physiologically active ingredient to release an effective concentration of the agent in the vicinity of the surface of the device; a hydrogel coating used to produce surface smoothness; Coating; corrosion resistant coating; one or more combinations of the above coatings, as well as other coatings used to improve device performance. It thus satisfies the long-felt need for a thin, firmly bonded smooth coating for indwelling medical devices.
  • a drug coating that acts as a surface reservoir for the physiologically active ingredient to release an effective concentration of the agent in the vicinity of the surface of the device
  • a hydrogel coating used to produce surface smoothness
  • Coating corrosion resistant coating
  • one or more combinations of the above coatings, as well as other coatings used to improve device performance it thus satisfies the long-felt need for a thin, firmly bonded smooth coating for indwelling medical devices.
  • the bonding layer of the above coating layer since it needs to be left in the digestive system for a long period of time, even
  • the double-layer drainage tube is actually composed of three layers, and the inner layer is a specially treated and chemically smoothed Teflon.
  • the inner surface is very smooth, avoiding the adhesion of bile or protein;
  • the outer layer is a polyamide elastomer, which is used to provide the necessary strength to the drainage tube; there is also a layer of stainless steel mesh between them to ensure that the drainage tube has a certain expansion Sex.
  • the inner wall of the drainage tube does not adhere to the bile, and the outer wall has good biocompatibility with the body tissue while maintaining the dilatability of the drainage tube.
  • the middle of the stainless steel mesh also increases the thickness of the wall of the drainage tube, which actually reduces the effective drainage cross-sectional area inside the drainage tube, or enlarges the diameter of the drainage tube as a whole, which causes difficulty in inserting and removing the tube, and increasing patient suffering.
  • the technical problem to be solved by the present invention is to provide a double-layer drainage tube which has a simple structure and at the same time realizes that the inner wall does not adhere to the bile, and the outer portion and the body tissue have good biocompatibility.
  • the double-layer drainage tube provided by the present invention is composed of a closely-bonded inner layer and an outer layer, the inner layer is made of a hydrophobic material, and the outer layer is made of a human biocompatible material.
  • the inner layer is a hydrophobic material, which can ensure that the inner wall does not hang liquid, avoid the clogging of the drainage tube caused by the adhesion of bile, and the outer wall is made of human biocompatible material, which can be left in the human body for a long time and has good compatibility with the body tissue. Does not cause inflammation; ensures the smoothness and safety of the drainage tube.
  • biocompatible material of the human body is selected from one or more of polyurethane, polyethylene, silicone rubber or polyamide.
  • biocompatible material of the human body is preferably a polyurethane.
  • the thickness ratio of the outer layer to the inner layer is from 10 to 1000:1; preferably from 50 to 500:1; most preferably from 100 to 200:1.
  • hydrophobic material is preferably a fluoropolymer.
  • the fluoropolymer is preferably a polytetrafluoroethylene or a fluorinated ethylene propylene copolymer.
  • the hardness of the biocompatible material of the human body is preferably from 85 to 70 D, more preferably from 95 to 60 D.
  • the outer layer is also coated with a functional coating, the functional coating being a hydrophilic coating and/or a bioactive coating.
  • the drainage tube is one of a straight type, a 1/3 curved type, a medium curved type, a horn type, or a pig tail type.
  • the drainage tube is provided with a development mark.
  • the double-layer drainage tube according to the present invention is composed of a closely-bonded inner layer and an outer layer, the inner layer is made of a hydrophobic material, and the outer layer is made of a human biocompatible material. It can ensure that the inner wall does not hang liquid, avoid the clogging of the drainage tube caused by the adhesion of bile, the outer layer is soft, elastic and the surface is smooth, and has good compatibility with the body tissue, does not cause inflammation; compared with the prior art, it does not contain stainless steel.
  • the middle layer of the wire reduces the diameter of the outer tube, reduces the difficulty of insertion, increases the inner diameter of the drainage tube, improves the effective drainage cross-sectional area of the drainage tube, and has a simple structure and reduced manufacturing cost.
  • FIG. 1 is a schematic structural view of a drainage tube according to an embodiment of the present invention
  • FIG. 2 is a partially enlarged cross-sectional view showing an embodiment of the present invention.
  • the double-layer drainage tube provided by the present invention is composed of a closely-bonded inner layer 11 and an outer layer 12.
  • the inner layer 11 is made of a hydrophobic material
  • the outer layer 12 is biocompatible. Made of sexual materials.
  • the inner layer 11 is a hydrophobic material, which can ensure that the inner wall is not hanged, avoiding the clogging of the drainage tube caused by the adhesion of the bile
  • the outer layer 12 is made of a biocompatible material, which can be left in the human body for a long time and has a good phase with the body tissue. Capacitive, does not cause inflammation; ensures the smoothness and safety of the drainage tube.
  • the specific human biocompatible material type is not particularly limited, and considering the biocompatibility and cost of each material, the human biocompatible material is preferably one of polyurethane, polyethylene, silicone rubber and polyamide. kind or several.
  • the above human biocompatible materials each have advantages and disadvantages.
  • silica gel has a slightly better biocompatibility, but has poor insertion strength and radial expansion.
  • it is not easy to insert into the bile duct.
  • the biomaterial of the polyethylene material Capacitance is comparable to that of silica gel, and its strength and expansion are slightly better, but its hardness is higher and its bendability is poor. It cannot be bent at the body temperature according to the cavity needs, during insertion or during later use.
  • the polyurethane of the present invention is preferably used as an outer layer material, and the polyurethane has better compatibility with a hydrophobic material such as a fluoropolymer than the other biocompatible materials, and the interface bonding strength is high; and the polyurethane material encounters human body temperature. It has good distortion and can be bent according to the cavity condition without stabbing the body tissue; polyurethane is non-toxic and can be left in the human body for a long time, has good compatibility with the body tissue, does not cause inflammation; the most important It has good strength and radial expansion, and even in the absence of the middle layer of stainless steel wire, it provides better insertion strength, ensures that the drainage tube does not collapse during use, and ensures smooth flow of the drainage tube. Moreover, the developing ability of the polyurethane under the X-ray is good, and even if the stainless steel wire layer is not contained, the drainage tube of the present invention can be clearly observed under X-ray, which is convenient for the operator to accurately place.
  • hydrophobic materials are fluorine-containing or silane-based polymers, but organosilane materials are poor in chemical resistance.
  • hydrophobic materials are preferably fluoropolymer hydrophobic materials with more stable chemical properties and lower surface energy. Fluoropolymer hydrophobic materials have high heat resistance, chemical resistance, durability and weather resistance, especially for many solvents, hydrocarbons, various acids and bases, low surface energy (neither Lipophilic is also not hydrophilic, ie hydrophobic oleophobic) and hygroscopic properties. Moreover, the strong C-F bond makes such polymers very stable to redox.
  • the prepared drainage tube can be indwelled to the human body for a long period of time, and the physical and chemical properties are stable.
  • the double-sparing performance ensures that bile or other foreign matter does not adhere inside the drainage tube, and the drainage tube is ensured to be smooth.
  • the fluoropolymer can be selected from the group consisting of Polytetrafluoroethylene (PTFE), fluorinated ethylene propylene copolymer (FEP), perfluoroalkoxy polymer (PFA), copolymer of tetrafluoroethylene and ethylene (ETFE), polyvinylidene fluoride (PVDF) and poly Chlorotrifluoroethylene (PCTFE) and the like, but is not limited to the above materials.
  • PTFE Polytetrafluoroethylene
  • FEP fluorinated ethylene propylene copolymer
  • PFA perfluoroalkoxy polymer
  • ETFE polyvinylidene fluoride
  • PCTFE poly
  • the fluoropolymer is preferably a polytetrafluoroethylene or a fluorinated ethylene propylene copolymer, and the polytetrafluoroethylene has the characteristics of being acid and alkali resistant, resistant to various organic solvents, and almost insoluble in all solvents;
  • the propylene copolymer is a soft plastic which has lower tensile strength, abrasion resistance and creep resistance than many engineering plastics and has excellent chemical inertness. Compared with other fluoropolymer hydrophobic materials, the above two materials not only have superior double-stranding performance, but also have a smoother inner surface and less friction, which further reduces the possibility of bile wall hanging.
  • the relative thicknesses of the inner layer 11 and the outer layer 12 are not particularly limited, and the thicknesses of both may be adjusted according to the use and cost of the art.
  • the hardness of the outer layer material is preferably 85A to 70D, and further, the biocompatibility of the material with the body is related to the structure of the material itself, and whether the hardness of the material matches the body tissue, and therefore
  • the hardness of the human biocompatible material is more preferably 95A to 60D, and it has better biocompatibility with the body tissue within the above range.
  • the hydrophobic material of the inner layer 11 such as a fluoropolymer
  • mechanical properties such as hardness and strength are high and the price is also high.
  • the thickness of the inner layer is too large, the manufacturing cost of the drainage tube will increase; in addition, as the thickness of the inner layer increases, the hardness of the inner layer 11 will gradually increase, and if the hardness is too high, the hardness of the outer layer 12 will be different. Large, affecting the interfacial bonding properties of the biocompatible material such as polyurethane of the inner layer 11 and the outer layer 12; when the inner layer 11 is thin, the inner layer 11 has better flexibility and flexibility, and the outer layer 12 Materials such as polyurethane have better interfacial bonding properties.
  • the thickness ratio of the outer layer 12 to the inner layer 11 is from 10 to 1000:1; more preferably, the thickness ratio of the outer layer 12 to the inner layer 11 is from 50 to 500:1; most preferably, the outer layer 12 and the inner layer
  • the layer 11 has a thickness ratio of 100 to 200:1.
  • the outer layer 12 of the draft tube is further coated with a functional coating, the functional coating being a hydrophilic coating and/or a bioactive coating.
  • the hydrophilic coating can attract water molecules to form a "gelatinous" surface on the surface, reduce the resistance of the drainage tube when inserted, and further improve the biocompatibility of the drainage tube and the body tissue.
  • the hydrophilic coating material is not specifically limited, and the coating is selected from a material having a small frictional resistance.
  • it is preferably made of polyvinyl alcohol, polyvinylpyrrolidone, polyethylene glycol, polyacrylamide, polyacrylic acid, sodium polyacrylate, poly(2-hydroxyethyl methacrylate), maleic anhydride copolymer, ethylene vinyl alcohol.
  • Copolymer 2-methacryloyloxyethylphosphocholine or its copolymer, (2-hydroxyethyl methacrylate)-styrene block copolymer, various synthetic peptides, collagen, hyaluronate One or more of cellulose-based copolymers.
  • bioactive coating of the pharmaceutical ingredient outside the drainage tube.
  • a suitable coating can be selected according to the needs of the patient's condition.
  • antithrombotic agents such as heparin-quaternary ammonium complexes
  • antimicrobial agents such as various silver compounds, quaternary ammonium compounds such as benzalkonium chloride, phenol derivatives such as thymol, and antibiotics such as gentamicin, nourishment Ofloxacin, and rifamycin.
  • the shape of the drainage tube is not particularly limited, and in addition to the straight type shown in FIG. 1 which is commonly used in ERCP surgery, a 1/3 curved type, a medium curved type, a horn type or a pig tail type may be used. Selecting any of the above shapes, the double-layer structure of the present invention can realize that the inner wall of the present invention does not adhere to the bile, and the outer portion and the body tissue have good properties. Biocompatibility, simple structure, low cost technical effect.
  • the developing portion may be further provided on the drainage tube to facilitate positioning during the process of arranging the drainage tube.
  • the shape of the developing portion is not specifically limited, and may be annular, Strips, dots, or various forms of patterns such as crosshairs.
  • the double-layer drainage tube according to the present invention is composed of a closely-bonded inner layer and an outer layer, the inner layer is made of a hydrophobic material, and the outer layer is made of a human biocompatible material. It can ensure that the inner wall does not hang liquid, avoid the clogging of the drainage tube caused by bile adhesion, the outer wall is soft, elastic and smooth, has good compatibility with the body tissue, does not cause inflammation; and in the case of no middle layer of stainless steel wire, shrinks The diameter and cost of the outer tube reduce the insertion difficulty, and at the same time increase the inner diameter of the drainage tube, which improves the effective drainage cross-sectional area of the drainage tube.

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  • Ophthalmology & Optometry (AREA)
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Abstract

一种双层引流管（1），通过由紧密贴合的内层（11）和外层（12）构成，内层（11）由疏水材料制成，外层（12）由人体生物相容性材料制成。可以保证内壁不挂液，避免胆汁黏附造成引流管堵塞，外壁柔软、有弹性且表面光滑，与肌体组织具有良好的相容性，不会引发炎症；并且在没有不锈钢丝中层的情况下，缩小了外管的直径和成本，降低插入难度，同时增加了引流管（1）的内径，提升了引流管有效的引流横截面积。

Description

一种双层引流管 技术领域
本发明涉及医疗器械技术领域，具体地说，是一种双层引流管。
背景技术
随着内镜技术的不断发展及其附件的不断完善，目前十二指肠镜技术已然成为治疗肝胆胰疾病的重要措施，包括胆总管结石、胆管损伤、胆管狭窄、肝移植术后胆道并发症等。十二指肠镜技术的内容主要包括：诊断性内窥镜逆行胰胆管造影(endoscopic retrograde cholangiopancreatography ERCP)和治疗性ERCP。治疗性ERCP包括内镜十二指肠乳头括约肌切开术(endoscopic sphencterotomy，EST)、内镜胆道引流术(endoscopic biliary drainage，EBD)、内镜鼻胆管引流术(endoscopic nose biliaty drainage，ENBD)、经内镜胰管引流术(endoscopic retrograde pancreatodrainage，ERPD)和相应的内镜内瘘术等。随着治疗性ERCP(经内镜逆行性胰胆管造影术)的开展,与传统技术相比，内镜胆管引流术因其微创伤性,并发症少,且可重复性等优点，作为胆管引流首选已为多数临床医生认可。
“胆管引流管”又称“胆管引流管”，主要用于内窥镜胆道结石手术和内窥镜胆囊摘除术后进行胆汁引流，与十二指肠镜配套使用，通过插入一条留置引流管做暂时性胆汁引流。是一种简便有效地解除梗阻的方法，主要用于良、恶性胆管梗阻的术后减黄，化脓性胆管炎的诊疗等需要胆管引流的疾病。现有技术中已经有多种塑料引流管和金属引流管用于胆管引流，相对于金属引流管，塑料引流管价格更加便宜，扭曲性更好，并且更加易于插入。但是不论是塑料引流管还是金属引流管都存在容易堵塞，生物相容性差，没有足够的强度插入胆管或容易引发炎症等问题。
现有技术中已经就上述问题进行了研究，参考文献1(CN2531802Y)中公开了一种T型组合胆道引流管，该引流管的主体部分为一个由聚氯乙烯或乳胶或硅胶材料制成的T型三通管，其特殊之处在于该T型三通管的长臂上覆盖有一层由天然红橡胶材料构成的薄膜。手术操作时将此引流管的两条短臂留在腹腔内。聚氯乙烯或乳胶或硅胶材料对胆道内组织反应性较弱，可以避免对胆道的不良影响，不会造成过重的炎性反应，同时通过引流管长 臂表面的组织反应性强的天然红橡胶薄膜，它在腹腔内能使腹腔窦道早期形成而实现早期拔管。
参考文献2(CN1843516A)在参考文献1的基础上进行了进一步地改进，其只需在T型引流管支架体的一臂外表层设置一层不同于支架本体或支架体外表层材料的复合层，就可以实现手术时留置与体内的T形引流管支架体的两臂外表层既具有与肌体组织相容性好对胆道刺激损伤小，又具有与肌体组织相容性相对差能很快刺激引流管周围形成窦道的良好效果。
但是上述参考文献都是涉及T型引流管，主要用于胆道切开手术，需要在保证T型管与肌体的生物相容性的基础上，尽量促使窦道的形成和稳定，以此实现早期拔管。但是ERCP手术中采用的引流管并不需要考虑窦道形成的问题，并且其所采用聚氯乙烯材料的生物相容性较差，会对肌体造成损伤，造成炎症、增生等并发症。
参考文献3(CN1250382A)中公开了一种用于医疗装置表面涂层的结合层，通过将医疗装置如引流管等的表面用适当组成的薄的聚合物层涂覆使该薄层与基体表面良好的结合，从而使随后的涂层可以与所述的薄聚合物层牢固结合，然后将该装置用旨在提高医疗装置的性能和生物相容性的其他层涂覆。所述涂层可以包括：可作为生理活性成分表面储库的药物涂层，以便在装置表面的附近释放有效浓度的所述试剂；用来生产表面光滑性的水凝胶涂层；有颜色的涂层；抗腐蚀涂层；上述涂层中的一种或多种组合，以及用于提高装置性能的其他涂层。其以此满足了长期以来对用于留置医疗装置的薄的、结合牢固的光滑涂层的需要。但是通过在实践中的反馈，对于胆道引流管来说，由于其需要在消化系统内长期留置，所以即使采用上述涂层的结合层，也存在容易脱落的问题，难以满足长期使用的需要。
参考文献4(参见“Indications and Technical Methods of Endoscopic Biliary Stenting Using the Doublelayer Stent”，Igarashi Y,Miki K，New Challenges in Gastrointestinal Endoscopy，Springer Japan,2008:417-422)中公开了一种用于ERCP手术中的双层引流管，该双层引流管实际上是由三层构成，内层为一种经过特殊处理和化学平滑的特氟龙。内表面十分光滑，避免黏附有胆汁或者蛋白质；外层为聚酰胺弹性体，用于给引流管提供必要的强度；二者之间还设有一层不锈钢网，用以保证引流管具有一定的扩张性。以此实现了引流管内壁不黏附胆汁，外壁又与肌体组织具有良好的生物相容性，同时保持了引流管的扩张性。但是这样一个三层结构，除了造成成本增加外，中间的不锈 钢网也增加了引流管管壁的厚度，实际上会缩小引流管内部有效的引流横截面积，或者是扩大引流管整体的直径，造成插入拔管困难，病人的痛苦增加等问题。
因此，提供一种结构更简单，同时又能实现内壁不黏附胆汁，外部又与肌体组织具有良好的生物相容性的双层引流管成为本医疗领域的亟需。
发明内容
本发明要解决的技术问题是提供一种结构简单，同时又能实现内壁不黏附胆汁，外部与肌体组织具有良好的生物相容性的双层引流管。
为解决上述技术问题，本发明所提供的双层引流管，由紧密贴合的内层和外层构成，内层由疏水材料制成，外层由人体生物相容性材料制成。通过内层为疏水材料，可以保证内壁不挂液，避免胆汁黏附造成引流管堵塞，外壁采用人体生物相容性材料制成，可以长期留置在人体内，与肌体组织具有良好的相容性，不会引发炎症；保证了引流管的流畅性和安全性。
进一步地，人体生物相容性材料选自聚氨酯、聚乙烯、硅橡胶或聚酰胺中的一种或几种。
进一步地，人体生物相容性材料优选为聚氨酯。
进一步地，外层和内层的厚度比为10～1000：1；优选为50～500：1；最优选为100～200：1。
进一步地，疏水材料优选为含氟聚合物。
进一步地，含氟聚合物优选为聚四氟乙烯或氟化乙烯丙烯共聚物。
进一步地，人体生物相容性材料的硬度优选为85A至70D，更优选为95A至60D。
进一步地，外层上还涂覆有功能性涂层，功能性涂层为亲水性涂层和/或生物活性涂层。
进一步地，引流管为直型、1/3弯型、中弯型、喇叭型或猪尾巴型中的一种。
进一步地，所述引流管上设有显影标记。
综上，本发明所涉及的双层引流管，通过由紧密贴合的内层和外层构成，内层由疏水材料制成，外层由人体生物相容性材料制成。可以保证内壁不挂液，避免胆汁黏附造成引流管堵塞，外层柔软、有弹性且表面光滑，与肌体组织具有良好的相容性，不会引发炎症；与现有技术相比，不含有不锈钢丝中层，缩小了外管的直径，降低插入难度，同时增加了引流管的内径，提升了引流管有效的引流横截面积，结构简单，降低了制造成本。
附图说明
下面结合附图和具体实施方式对本发明作进一步详细的说明：
图1为本发明所提供的实施例的引流管的结构示意图
图2为本发明所提供的实施例的部分剖面放大结构示意图。
元件标号如下：
1-引流管
11-内层
12-外层
具体实施方式
现在结合附图，详细介绍本发明的较佳实施方式。虽然本发明的描述将结合各个实施方式一起介绍，但这并不代表此发明的特征仅限于该几种实施方式。恰恰相反，结合实施方式作发明介绍的目的是为了覆盖基于本发明的权利要求而有可能延伸出的其它选择或改造。为了提供对本发明的深度了解，以下描述中将包含许多具体的细节。本发明也可以不使用这些细节实施。此外，为了避免混乱或模糊本发明的重点，有些具体细节将在描述中被省略。
另外，在以下的说明中所使用的“上”、“下”、“左”、“右”、“顶”、“底”，是为了更好地描述本发明的较佳实施方式而设定的，不应理解为对本发明的限制。
实施例1
如图1和图2所示，本发明所提供的双层引流管，由紧密贴合的内层11和外层12构成，内层11由疏水材料制成，外层12由人体生物相容性材料制成。通过内层11为疏水材料，可以保证内壁不挂液，避免胆汁黏附造成引流管堵塞，外层12采用人体生物相容性材料制成，可以长期留置在人体内，与肌体组织具有良好的相容性，不会引发炎症；保证了引流管的流畅性和安全性。
进一步地，具体的人体生物相容性材料种类没有特殊的限定，综合考虑各材料的生物相容性和成本，人体生物相容性材料优选为聚氨酯、聚乙烯、硅橡胶和聚酰胺中的一种或几种。
进一步地，作为外层材料，上述人体生物相容性材料各有优缺点。例如硅胶的生物相容性稍好，但是插入强度和径向扩张性都较差，采用其作为外管材料时，不易于插入胆管 内；在处于工作位置时，当受到腔体内壁的挤压，不能够较好的维持引流管的径向扩张性，使得引流管的有效引流横截面积得不到保证；聚乙烯材料生物相容性与硅胶相当、强度和扩张性稍好，但是其硬度较高，可弯曲性较差，不能够在人体温度下根据腔体需要发生弯转，插入过程中或者是后期使用过程中都有可能会刺伤内壁，可能会引发炎症、增生等并发症；如参考文献4中采用的聚酰胺，其生物相容性较好，但是其吸水性较大，在人体复杂的内环境下，尺寸稳定性会受到一定程度的影响；并且其生物相容性、强度和径向扩张性都远逊于聚氨酯，在没有中层不锈钢丝的情况下，引流管的插入强度、径向扩张性和X光下的显影性都会有所下降。
本发明优选聚氨酯作为外层材料，相较于其他生物相容性材料，聚氨酯与疏水材料如含氟聚合物具有更好的相容性，界面结合强度高；并且聚氨酯材料在遇到人体温度时有很好的扭曲性，可以根据腔体情况弯曲，而不会刺伤肌体组织；聚氨酯无毒，可以长期留置在人体内，与肌体组织具有良好的相容性，不会引发炎症；最重要的是，其具有良好的强度和径向扩张性，即使在没有不锈钢丝中层的情况下，也提供了较好的插入强度，确保引流管使用过程中并且不会塌陷，保证了引流管的流畅，并且聚氨酯在X线下的显影能力较好，即使不含有不锈钢丝层，在X光下也可以清晰的观察到本发明的引流管，便于操作人员准确放置。
常见的疏水材料有含氟或者是硅烷类聚合物，但是有机硅烷材料耐化学介质差，在用作引流管时，疏水材料优选化学性能更稳定，表面能更低的含氟聚合物疏水材料，含氟聚合物疏水材料具有高的耐热性、耐化学腐蚀性、耐久性和耐候性，特别是对于许多溶剂、碳氢化合物、各种酸碱的不活泼性，低的表面能(既不亲油也不亲水，即疏水疏油)和吸湿性能。而且C-F键强的键能使得此类聚合物对于氧化还原具有非常强的稳定性。制成的引流管可以长期留置人体内，物理化学性能稳定，通过双疏性能保证了引流管内部不会黏附有胆汁或者是其他异物，保证引流管的通畅，所述含氟聚合物可以选自聚四氟乙烯(PTFE)、氟化乙烯丙烯共聚物(FEP)、全氟烷氧基聚合物(PFA)、四氟乙烯与乙烯的共聚物(ETFE)、聚偏氟乙烯(PVDF)和聚三氟氯乙烯(PCTFE)等等，但并不局限于上述材料。
更进一步地，含氟聚合物优选为聚四氟乙烯或氟化乙烯丙烯共聚物，聚四氟乙烯具有抗酸抗碱、抗各种有机溶剂的特点，几乎不溶于所有的溶剂；氟化乙烯丙烯共聚物是一种软性塑料，其拉伸强度、耐磨性、抗蠕变性低于许多工程塑料，具有优异的化学惰性。相对于其他含氟聚合物疏水材料来说，上述两种材料不但双疏性能更优异，制成的内表面也更加光滑，摩擦力更小，进一步减少了胆汁挂壁的可能。
本发明中，对内层11和外层12的相对厚度没有特殊的限定，可以根据本领域使用和成本的需要调节二者的厚度。
进一步地，对于外层材料，需要有合适的硬度，如果硬度过低，将难以为引流管提供合适的插入强度和径向扩张性能；如果硬度过高又容易刺伤肌体内壁，造成增生或者炎症等并发症。因此，外层材料的硬度优选为85A至70D，更进一步地，对于材料与肌体的生物相容性，除了与材料本身的结构有关，与该材料的硬度是否与肌体组织相匹配也有关，因此，人体生物相容性材料硬度更优选为95A至60D，在上述范围内可以与肌体组织具有更好的生物相容性。
一般来说，作为内层11的疏水材料如含氟聚合物，硬度、强度等机械性能都较高，价格也较高。如果内层厚度过大，会增加引流管的制造成本；除此之外，随着内层厚度增加，内层11的硬度也会逐渐提升，如果硬度过高，与外层12的硬度相差过大，会影响内层11与外层12的生物相容性材料如聚氨酯的界面结合性能；当内层11较薄时，内层11的柔韧性和可弯曲性较好，与外层12的材料如聚氨酯等界面结合性能较好。优选地，外层12和内层11的厚度比为10～1000：1；更优选地，外层12和内层11的厚度比为50～500：1；最优选地，外层12和内层11的厚度比为100～200：1。
进一步地，引流管外层12上还涂覆有功能性涂层，功能性涂层为亲水性涂层和/或生物活性涂层。亲水性涂层可以吸引水分子在其表面形成“凝胶状”表面，降低引流管插入时的阻力，同时可以进一步提升引流管与肌体组织的生物相容性。对于亲水涂层材料并没有具体的限定，涂层选由摩擦阻力小的材料形成。例如优选由聚乙烯醇、聚乙烯吡咯烷酮、聚乙二醇、聚丙烯酰胺、聚丙烯酸、聚丙烯酸钠、聚(甲基丙烯酸2-羟基乙酯)、马来酸酐系共聚物、乙烯-乙烯醇共聚物、2-甲基丙烯酰氧乙基磷酸胆碱或其共聚物、(甲基丙烯酸2-羟基乙酯)-苯乙烯嵌段共聚物、各种合成多肽、胶原蛋白、透明质酸盐、纤维素系共聚物中的一种或多种。
更进一步地，还可以在引流管外部涂覆药物成分的生物活性涂层。对于生物涂层的种类没有具体的限定，可以根据患者病情的需要选择合适的涂层。例如，抗血栓形成剂，如肝素-季铵配合物；抗微生物剂如各种银化合物、季铵化合物如苯扎氯铵、苯酚衍生物如麝香草酚、和抗生素例如庆大霉素、诺氟沙星、和利福霉素等。
进一步地，引流管的形状没有特殊的限定，除了可以选择ERCP手术中常用的图1中所示的直型以外，1/3弯型、中弯型、喇叭型或猪尾巴型也可以采用，选择上述任一种形状采用本发明的双层结构可以实现本发明内壁不黏附胆汁，外部又与肌体组织具有良好的 生物相容性，结构简单，成本低的技术效果。
更进一步地，为了操作人员便于观察，引流管上还可以设有显影部，便于安置引流管的过程中进行定位，显影部的形状没有具体的限定，只要便于观察即可，可以是环状、条状、点状，也可以是十字标线等各种形式的图案。当引流管进入患者体内后，显影部可以清楚地显示引流管所处的位置，方便操作人员更好的监控引流管安置的情况。
综上，本发明所涉及的双层引流管，通过由紧密贴合的内层和外层构成，内层由疏水材料制成，外层由人体生物相容性材料制成。可以保证内壁不挂液，避免胆汁黏附造成引流管堵塞，外壁柔软、有弹性且表面光滑，与肌体组织具有良好的相容性，不会引发炎症；并且在没有不锈钢丝中层的情况下，缩小了外管的直径和成本，降低插入难度，同时增加了引流管的内径，提升了引流管有效的引流横截面积。
上述的说明是本发明中具体实施方式的实施例，用于更清楚地说明本发明的发明构思，但其并非是用于对本发明的权利要求范围的限定。根据本发明的发明构思，本领域技术人员能够容易变型和修改上述的实施例，这些属于本发明的发明构思内的变型和修改均包含在本发明后附的权利要求的范围之内。

Claims (10)

  1. 一种双层引流管，其特征在于，由紧密贴合的内层和外层构成，所述内层由疏水材料制成，所述外层由人体生物相容性材料制成。
  2. 如权利要求1所述的引流管，其特征在于，所述人体生物相容性材料选自聚氨酯、聚乙烯、硅橡胶或聚酰胺中的一种或几种。
  3. 如权利要求1所述的引流管，其特征在于，所述人体生物相容性材料为聚氨酯。
  4. 如权利要求1所述的引流管，其特征在于，所述外层和所述内层的厚度比为10～1000：1。
  5. 如权利要求1所述的引流管，其特征在于，所述疏水材料为含氟聚合物。
  6. 如权利要求5所述的引流管，其特征在于，所述含氟聚合物为聚四氟乙烯或氟化乙烯丙烯共聚物。
  7. 如权利要求1所述的引流管，其特征在于，所述人体生物相容性材料的硬度为85A至70D。
  8. 如权利要求1所述的引流管，其特征在于，所述外层上还涂覆有功能性涂层，所述功能性涂层为亲水性涂层和/或生物活性涂层。
  9. 如权利要求1所述的引流管，其特征在于，所述引流管为直型、1/3弯型、中弯型、喇叭型或猪尾巴型中的一种。
  10. 如权利要求1所述的引流管，其特征在于，所述引流管上设有显影标记。
PCT/CN2017/105627 2016-12-26 2017-10-11 一种双层引流管 WO2018120982A1 (zh)

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