CN108294802B - Double-layer U-shaped tubular tissue ligation clamp and preparation method thereof - Google Patents
Double-layer U-shaped tubular tissue ligation clamp and preparation method thereof Download PDFInfo
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- CN108294802B CN108294802B CN201810060437.2A CN201810060437A CN108294802B CN 108294802 B CN108294802 B CN 108294802B CN 201810060437 A CN201810060437 A CN 201810060437A CN 108294802 B CN108294802 B CN 108294802B
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- clip
- polyglycolide
- clamp
- tubular tissue
- shaped tubular
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/122—Clamps or clips, e.g. for the umbilical cord
-
- 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
- A61L17/00—Materials for surgical sutures or for ligaturing blood vessels ; Materials for prostheses or catheters
- A61L17/005—Materials for surgical sutures or for ligaturing blood vessels ; Materials for prostheses or catheters containing a biologically active substance, e.g. a medicament or a biocide
-
- 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
- A61L17/00—Materials for surgical sutures or for ligaturing blood vessels ; Materials for prostheses or catheters
- A61L17/06—At least partially resorbable materials
- A61L17/10—At least partially resorbable materials containing macromolecular materials
- A61L17/12—Homopolymers or copolymers of glycolic acid or lactic acid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B2017/12004—Surgical 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
-
- 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
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
- A61L2300/204—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials with nitrogen-containing functional groups, e.g. aminoxides, nitriles, guanidines
- A61L2300/206—Biguanides, e.g. chlorohexidine
-
- 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
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/404—Biocides, antimicrobial agents, antiseptic agents
-
- 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
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/412—Tissue-regenerating or healing or proliferative agents
-
- 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
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
- A61L2300/602—Type of release, e.g. controlled, sustained, slow
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Surgery (AREA)
- Engineering & Computer Science (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Vascular Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Materials Engineering (AREA)
- Epidemiology (AREA)
- Biomedical Technology (AREA)
- Molecular Biology (AREA)
- Reproductive Health (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Heart & Thoracic Surgery (AREA)
- Medical Informatics (AREA)
- Materials For Medical Uses (AREA)
Abstract
The invention discloses a double-layer U-shaped tubular tissue ligating clip and a preparation method thereof, wherein the hemostatic ligating clip comprises an inner clip and an outer clip, the outer clip is in a U-shaped opening structure and is made of polyglycolide; the inner clip is in a U-shaped opening structure and is made of a blend of polyglycolide and polytrimethylene carbonate; the inner clamp and the outer clamp are provided with anti-falling parts, and the anti-falling parts comprise T-shaped guide strips arranged on the inner side plane of the outer clamp and clamping grooves which are arranged on the outer side plane of the inner clamp and are matched with the T-shaped guide strips; the blend material has better hydrophilicity and better tissue compatibility, and the prepared ligation clip has moderate hardness and does not damage human tissues; in addition, polyhexamethylene biguanide hydrochloride is added in the raw material synthesis process and slowly released along with the degradation of the material, so that the bacteriostatic wound healing can be effectively promoted; the degradation rate of the materials required by different tissues of a body can be adapted by changing the molecular weight and the blending ratio of the raw materials; and the processing is simple and the safety is higher.
Description
Technical Field
The invention relates to a special consumable for performing laparoscopic surgery, in particular to a U-shaped tubular tissue ligation clamp with a double-layer structure and a preparation method thereof.
Background
Ligation forceps and suture ligation are mainly adopted in early ligation surgical operations, and due to inconvenience in use and complex process, the operation time is greatly increased, the energy of doctors is consumed, and the operation risk is increased; although the strength of the metal ligature clamp which appears later meets the requirement and is convenient to use, the metal ligature clamp can not be degraded and absorbed, so that the metal ligature clamp exists in the body for a long time and has stimulation to tissues to different degrees, and complications such as inflammation and the like are generated; meanwhile, the metal clip can affect the X-ray examination and cause misjudgment of doctors. The degradable metal ligation clip appearing in recent years is mainly Mg alloy, and cannot be widely applied due to uncontrollable degradability; in addition, the ligation clip made of non-degradable plastics is not widely used because it can cause various complications such as inflammation due to its long-term existence in the body. At present, some ligature clamps prepared by biodegradable materials appear at home and abroad, the main materials of the ligature clamps are polyglycolide, polydioxanone and blends thereof, but no ligature clamp prepared by blending the biodegradable materials is seen, compared with metal clamps and non-absorbable clamps, the ligature clamp made of the biodegradable materials can be degraded and absorbed by a human body within a certain time range, basically has no foreign body reaction and good biocompatibility, so long-term foreign body stimulation to human tissues can not be generated, the complications are few, and the X-ray inspection is not influenced.
The absorbable clamp produced by the medical appliances of the vigorous growth limited company and the biological technology limited company of the Ministry of Hangzhou is a single-layer absorbable blood vessel ligation clamp, adopts poly-p-dioxanone, has a V-shaped structure and is provided with a locking hook at the locking part. This can absorb clamp need separate the tissue that blocks in clip front end closure department before the closure tissue of ligature operation, just can accomplish the ligature operation, otherwise makes human tissue be caught in clip closure department easily, can not normally seal to the tissue is dragged repeatedly, thereby causes the injury to the tissue. This poses two important disadvantages: 1) the requirement on the technical skill of an operator is high; 2) can not be applied to the operations of acute hemorrhage, separation after clamping, and the like (such as liver lobe resection and the like).
An absorbable clamp produced by Hangzhou Shengshi science and technology limited company, Chinese patent No. CN 101081310A, is a double-layer absorbable blood vessel ligation clamp which is divided into an inner layer and an outer layer, wherein the outer layer adopts polyglycolide; the inner layer is poly (p-dioxanone), the material has a long degradation period in a human body, the complete degradation needs more than 6 months, and the material can be completely absorbed by the human body after about 10 months; and the product has short shelf life, which is only one year and half.
Disclosure of Invention
The invention aims to provide a double-layer U-shaped tubular tissue ligation clamp and a preparation method thereof, aiming at the problems in the prior art.
In order to achieve the purpose, the invention adopts the technical scheme that:
a double-layer U-shaped tubular tissue ligation clamp comprises an inner clamp and an outer clamp, wherein the outer clamp is of a U-shaped opening structure and is made of polyglycolide; the inner clip is in a U-shaped opening structure and is made of a mixture of polyglycolide and polytrimethylene carbonate; the anti-disengaging structure is characterized in that anti-disengaging parts are arranged on the inner clamp and the outer clamp, and each anti-disengaging part comprises a T-shaped conducting bar arranged on the inner side plane of the outer clamp and a clamping groove matched with the T-shaped conducting bar on the outer side plane of the inner clamp.
The T-shaped guide strip and the clamping groove are matched with each other to play a guiding function in the axial direction and play a limiting role in the radial direction to prevent the T-shaped guide strip and the clamping groove from falling off; meanwhile, the outer clip is polyglycolide, the inner clip is made of polyglycolide and polytrimethylene carbonate blend, the degradation rates of the inner clip and the outer clip can be kept consistent and the degradation rate of the blend can be adjusted by controlling the proportion of each component of the polyglycolide and the polytrimethylene carbonate blend so as to be suitable for different parts of human bodies.
Preferably, the width of the top end surface of the T-shaped guide strip is smaller than that of the outer clip, so that the occupied space can be saved, and the hemostatic ligation clip has a compact structure.
Preferably, the width of the inner clamp is the same as that of the outer clamp, so that the hemostatic ligation clamp is more compact in structure and convenient to clamp.
The invention also provides a preparation method of the double-layer U-shaped tubular tissue ligation clip, which comprises the following steps:
s1 preparation of raw materials
(a) Preparing polyglycolide:
putting a certain amount of glycolide into a reaction kettle, adding a stannous octoate catalyst with the mass concentration of 0.01%, setting the reaction temperature to be 150-;
the preparation of the polyglycolide adopts a ring-opening polymerization method, namely, glycolic acid monomer is used for carrying out a ring-closing reaction to generate a cyclic product glycolide, and the generated cyclic product glycolide is purified to ensure that the purity of the cyclic product glycolide is higher than 99.92 percent; then carrying out ring-opening polymerization reaction on the cyclic product glycolide to form polyglycolide;
(b) preparation of polytrimethylene carbonate:
adding a certain amount of hexahydric cyclic trimethylene carbonate monomer into a reaction kettle, adding a stannous octoate catalyst with the mass concentration of 0.01%, preparing polytrimethylene carbonate through ring-opening polymerization under the vacuum or high-pressure condition, setting the reaction temperature at 150 ℃ and 180 ℃, reacting for 3-5h, and then refluxing, purifying and granulating to obtain a product, wherein the product is sealed and stored;
(c) preparation of polyglycolide and polytrimethylene carbonate blends:
blending and extruding the polyglycolide prepared in the step and the polytrimethylene carbonate according to the mass ratio of 100: 0-70: 30, and granulating to obtain a product, and sealing and storing the product;
s2 molding process
The U-shaped tubular tissue ligation clamp with the double-layer structure is formed by injection molding or compression molding;
the compression molding temperature is 225 ℃;
the injection molding conditions comprise that the mold preheating temperature is 50-70 ℃, the injection molding temperature is 190-210 ℃ and the injection molding period is 25-35s, and then the U-shaped tubular tissue ligation clamp of the injection molded product is subjected to heat treatment; (ii) a
S3, sterilizing and packaging.
The method is characterized in that low-molecular-weight polyvinyl alcohol PVA is introduced into molecular chains of raw materials polyglycolide and polytrimethylene carbonate polymer by a graft modification method, and hydrophilic group hydroxyl is introduced, so that the hydrophilicity is greatly improved, and the biocompatibility between the polyvinyl alcohol PVA and tissues is increased; meanwhile, the inner clamp is prepared by blending polyglycolide and polytrimethylene carbonate, the preparation method is simpler, and the degradation product is a human metabolite; due to the special three-dimensional interpenetrating network structure of the blend and the diversity of the degradation rates, two phases of the blend play a supporting role together in the early stage of degradation of the product, and the degradation rate is changed along with the change of the blending ratio of the polyglycolide to the polytrimethylene carbonate; meanwhile, in the synthesis process of the polyglycolide and the polytrimethylene carbonate raw materials, a certain amount of micromolecular polymer PHMB, namely polyhexamethylene biguanide hydrochloride, is added and combined with the raw material polymer in a weak interaction hydrogen bond or hydrophilic action mode, and PHMB micromolecular chains are interpenetrated among the raw material molecular chains and are slowly released along with the degradation of the product, so that the wound healing can be effectively promoted by bacteriostasis; in addition, the medical pigment is adopted to color the inner clip material, so that the inner clip, the outer clip and the human tissue can be distinguished more conveniently, the operation error is reduced, and the safety is improved.
Preferably, the polyglycolide, the polytrimethylene carbonate and the blend of polyglycolide and polytrimethylene carbonate in the step S1 are all particles with a diameter of 1.5 to 2mm and a length of 3mm after granulation.
Preferably, the polyglycolide and polytrimethylene carbonate product obtained in step S1 have a viscosity ranging from 1.2 to 3.5dL/g and a melt index ranging from 25 to 65g/10 min.
Preferably, in the preparation method of the U-shaped tubular tissue ligation clip with the double-layer structure, the heat treatment in the step S2 is performed at a temperature of 40-60 ℃ for 2-5 hours.
Preferably, the sterilization manner in step S3 is irradiation sterilization.
Compared with the prior art, the invention has the beneficial effects that:
(1) according to the U-shaped tubular tissue ligation clamp with the double-layer structure, polyvinyl alcohol with low molecular weight is introduced to the molecular chains of raw materials polyglycolide and poly trimethylene carbonate polymer by a grafting modification method, and hydrophilic groups and hydroxyl groups are introduced, so that the hydrophilicity is greatly improved; the inner clip of the U-shaped tubular tissue ligation clip is made of a blend material of polyglycolide and polytrimethylene carbonate, and the material is moderate in hardness, better in hydrophilic performance and better in tissue compatibility, and does not damage human tissues; in addition, polyhexamethylene biguanide hydrochloride is added in the synthesis process of raw materials polyglycolide and poly trimethylene carbonate, and is combined with the raw material polymer in a weak interaction hydrogen bond or hydrophilic action mode, and PHMB small molecular chains are inserted among the raw material molecular chains and are slowly released along with the degradation of the product, so that the bacteriostatic effect can be effectively realized, and the wound healing can be promoted;
(2) the outer clamp of the U-shaped tubular tissue ligation clamp with the double-layer structure adopts a polyglycolide material, and the degradation rate is mainly controlled by changing the molecular weight of the polyglycolide polymer; the inner clamp can control the degradation rate by controlling the blending ratio of polyglycolide and poly trimethylene carbonate besides changing the molecular weight of the polymer, so as to be suitable for different parts of human body;
(3) the U-shaped tubular tissue ligation clamp with the double-layer structure is made of the blended material through injection molding, the process is simple, convenient and feasible, the U-shaped tubular tissue ligation clamp is more suitable for large-scale production, the cost is reduced, and the efficiency and the yield are greatly improved;
(4) the anti-falling part is arranged on the inner clamp and the outer clamp of the U-shaped tubular tissue ligation clamp with the double-layer structure, the anti-falling part comprises a T-shaped conducting bar arranged on the inner side plane of the outer clamp and a clamping groove arranged on the outer side plane of the inner clamp and matched with the T-shaped conducting bar, and the T-shaped conducting bar and the clamping groove are matched with each other to play a guiding function in the axial direction and play a limiting role in the radial direction to prevent the T-shaped conducting bar from falling off, so that the clamping of tubular tissues or other intracavity tissues in a human body is facilitated; and the whole structure is compact, the use is convenient, the products and the tissues are easy to distinguish, the dislocation is avoided, and the safety is higher.
Drawings
FIG. 1 is a schematic structural view of a double-layered U-shaped tubular tissue ligating clip according to the present invention;
FIG. 2 is a schematic structural view of the inner clip and the outer clip after being engaged;
FIG. 3 is a cross-sectional view of the inner clip engaged with the outer clip;
in the figure: 1. an outer clamp; 11. a "T" shaped guide bar; 2. internal clamping; 21. a clamping groove.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is further described in detail with reference to the following embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention. Reagents, methods and apparatus used in the present invention are conventional in the art unless otherwise indicated.
As a preferable preparation method, the preparation method of the U-shaped tubular tissue ligation clip with the double-layer structure comprises the following steps:
s1 preparation of raw materials
(a) Preparing polyglycolide:
putting a certain amount of glycolide into a reaction kettle, adding a stannous octoate catalyst with the mass concentration of 0.01%, setting the reaction temperature to be 150-;
(b) preparation of polytrimethylene carbonate:
adding a certain amount of hexahydric annular trimethylene carbonate monomer into a reaction kettle, adding a stannous octoate catalyst with the mass concentration of 0.01%, preparing polytrimethylene carbonate through ring-opening polymerization under the vacuum or high-pressure condition, setting the reaction temperature at 150 ℃ and 180 ℃, reacting for 3-5h, and then refluxing, purifying and granulating to obtain a product, wherein the product is hermetically stored;
(c) preparation of polyglycolide and polytrimethylene carbonate blends:
blending and extruding polyglycolide and polytrimethylene carbonate prepared in the steps according to the mass ratio of 100: 0-70: 30, granulating, and cutting into particles with the diameter of 1.5-2mm and the length of 3 mm;
s2 molding process
The U-shaped tubular tissue ligation clamp with the double-layer structure is formed by injection molding or compression molding;
the compression molding temperature is 225 ℃;
the injection molding conditions comprise that the mold preheating temperature is 50-70 ℃, the injection molding temperature is 190-210 ℃ and the injection molding period is 25-35s, and then the injection molded U-shaped tubular tissue ligation clip is subjected to heat treatment;
s3, sterilizing and packaging.
More preferably, in the method for preparing the U-shaped tubular tissue ligation clip with the double-layer structure, the polyglycolide, the polytrimethylene carbonate and the blend of the polyglycolide and the polytrimethylene carbonate in the step S1 are all particles with the diameter of 1.5-2mm and the length of 3mm after being granulated.
More preferably, in the preparation method of the U-shaped tubular tissue ligation clip with the double-layer structure, the product of polyglycolide and polytrimethylene carbonate obtained in the step S1 has a viscosity ranging from 1.2 to 3.5dL/g and a melt index ranging from 25 to 65g/10 min.
More preferably, in the method for preparing the U-shaped tubular tissue ligation clip with the double-layer structure, the heat treatment in the step S2 is performed at a temperature of 40-60 ℃ for 2-5 hours.
More preferably, in the method for preparing the U-shaped tubular tissue ligation clip with the double-layer structure, the sterilization manner in the step S3 is irradiation sterilization.
Example 1
Preparing polyglycolide:
putting 200g of glycolide into a reaction kettle, adding a stannous octoate catalyst with the mass concentration of 0.01%, reacting for 6h under the vacuum condition at 160 ℃, adding reactants into an extruder at 160 ℃ to obtain granular polyglycolide with the particle size of 1.5-2mm and the length of 3mm, and drying the granules in vacuum at 40 ℃ for 24 h. The melting index of polyglycolide is measured to be 50g/10min by a melting index instrument under the test condition of 230 ℃/2.16kg and adopting an ASTM D1238 test method.
The polyglycolide prepared by the method is processed into the outer clip of the ligature clip by the injection molding process.
Preparation of polytrimethylene carbonate:
200g of six-membered cyclic trimethylene carbonate monomer is put into a reaction kettle, 0.01 percent of stannous octoate catalyst is added, the reaction is carried out for 4 hours at 160 ℃ under the vacuum condition, the reactant is added into an extruding machine after the reaction is finished, granular polytrimethylene carbonate with the size of 1.5-2mm is obtained, the granules are dried under vacuum at 40 ℃ for 24 hours, 198g is weighed, and the yield is 99 percent. The intrinsic viscosity of the polytrimethylene carbonate was measured to be 2.4dL/g in a thermostatic water bath at 25 ℃ with a Ubbelohde viscometer using a hexafluoroisopropanol solution as a solvent.
Example 2
Preparation of polyglycolide and polytrimethylene carbonate blends: the polyglycolide and the polytrimethylene carbonate prepared in example 1 were weighed in a mass ratio of 100:0, and 200g was blended, extruded, pelletized, cut into pellets having a diameter of 1.5 to 2mm and a length of 3mm, and weighed to obtain 196g of pellets, with a yield of 98%. The pellets were dissolved in a hexafluoroisopropanol solution, and the intrinsic viscosity of the blend was 3.48dL/g as measured in a thermostatic water bath at 25 ℃ using an Ubbelohde viscometer.
The polyglycolide and polytrimethylene carbonate blend prepared above is processed into the inner clip of the ligature clip by the injection molding process of the invention.
Example 3
Preparation of polyglycolide and polytrimethylene carbonate blends: the polyglycolide and the polytrimethylene carbonate prepared in example 1 were weighed in a mass ratio of 90:10, and 200g was blended, extruded, pelletized, cut into pellets having a diameter of 1.5 to 2mm and a length of 3mm, and weighed to obtain 196g of pellets, and the yield was 98%. The pellets were dissolved in a hexafluoroisopropanol solution, and the intrinsic viscosity of the blend was 3.62dL/g as measured in a thermostatic water bath at 25 ℃ using an Ubbelohde viscometer.
The polyglycolide and polytrimethylene carbonate blend prepared above is processed into the inner clip of the ligature clip by the injection molding process of the invention.
Example 4
Preparation of polyglycolide and polytrimethylene carbonate blends: the polyglycolide and the polytrimethylene carbonate prepared in example 1 were weighed in a mass ratio of 80:20, and 200g was blended, extruded, pelletized, cut into pellets having a diameter of 1.5 to 2mm and a length of 3mm, and weighed to obtain 198g of pellets, with a yield of 99%. The pellets were dissolved in a hexafluoroisopropanol solution, and the intrinsic viscosity of the blend was measured by an Ubbelohde viscometer in a constant temperature water bath at 25 ℃ and was 3.36 dL/g.
The polyglycolide and polytrimethylene carbonate blend prepared above is processed into the inner clip of the ligature clip by the injection molding process of the invention.
Example 5
Preparation of polyglycolide and polytrimethylene carbonate blends: the polyglycolide and the polytrimethylene carbonate prepared in example 1 are weighed according to the mass ratio of 70:30, and 200g of the polyglycolide and the polytrimethylene carbonate are blended, extruded, granulated and cut into particles with the diameter of 1.5-2mm and the length of 3mm, and the granules are weighed to obtain 197g of granules, and the yield is 98.5%. The pellets were dissolved in a hexafluoroisopropanol solution, and the intrinsic viscosity of the blend was 3.85dL/g as measured in a thermostatic water bath at 25 ℃ using an Ubbelohde viscometer.
The polyglycolide and polytrimethylene carbonate blend prepared above is processed into the inner clip of the ligature clip by the injection molding process of the invention.
Comparative example 1
Preparation of polyglycolide and polytrimethylene carbonate blends: compared with example 4, the difference is that the blend is synthesized by blending polyglycolide and polytrimethylene carbonate according to the mass ratio of 50:50, and the intrinsic viscosity of the blend is 2.18dL/g determined according to the method of example 4.
The polyglycolide and polytrimethylene carbonate blend prepared above is processed into the inner clip of the ligature clip by the injection molding process of the invention.
Comparative example 2
A blend of polyglycolide and polydioxanone was prepared, which was different from example 4 in that the blend was prepared by blending polyglycolide and polydioxanone at a ratio of 80:20 by mass, and the rest was the same as example 4, and a blend of polyglycolide and polydioxanone was synthesized, which had an intrinsic viscosity of 3.28dL/g measured by the method of example 4.
The polyglycolide and polydioxanone blend prepared by the method is processed into the ligation clip inner clip by the injection molding process.
Comparative example 3
A copolymer of polyglycolide and polytrimethylene carbonate is prepared, which is different from example 4 in that 200g of the copolymer prepared in example 1 is weighed and placed in a reaction kettle according to the mass ratio of 80:20, 0.01% of stannous octoate catalyst is added, the mixture is reacted for 10 hours at 140 ℃ under vacuum condition, reactants are added into an extruder at 140 ℃ to obtain particles with the diameter of 1.5-2mm and the length of 3mm, and after the particles are dried for 24 hours under vacuum at 40 ℃, the intrinsic viscosity measured according to the method of example 4 is 1.98 dL/g.
The polyglycolide and polytrimethylene carbonate copolymer prepared above is processed into the inner clip of the ligature clip by the injection molding process of the invention.
Application example 1
The ligation clip prepared by the injection molding process disclosed by the invention comprises an inner clip 2 and an outer clip 1, wherein the outer clip 1 is of a U-shaped opening structure, as shown in figures 1-3; the inner clamp 2 is of a U-shaped opening structure; the inner clamp 2 and the outer clamp 1 are provided with anti-falling parts, and the anti-falling parts comprise T-shaped guide strips 11 arranged on the inner side plane of the outer clamp 1 and clamping grooves 21 which are arranged on the outer side plane of the inner clamp 2 and are matched with the T-shaped guide strips 11; the width of the top end surface of the T-shaped guide strip 11 is smaller than that of the outer clamp 1; the width of the inner clip 2 is the same as that of the outer clip 1. The outer clamp is manufactured by the injection molding process of the embodiment 1, and the inner clamp is manufactured by the injection molding processes of the embodiments 2-5 and the comparative examples 1-3.
The ligation clip prepared above was subjected to a simulated body fluid degradation test. Each set of ligation grips 500 samples, accurately weighed and placed in 50mL centrifuge tubes (10 ligation grips/centrifuge tube), and 35mL of phosphate buffered solution pH 7.4 was added. The centrifugal tube is sealed by tinfoil paper and put into a constant temperature water bath shaking table at 37 ℃ for degradation, and the phosphoric acid buffer solution is replaced every 2 weeks. After a certain degradation time, the buffer solution is removed by filtration, and the weight of the ligation clip is determined after vacuum drying. The weight retention (ratio of the weight of the clip after degradation over time to the weight of the clip before degradation) was calculated. Repeating the step of replacing the phosphate buffer solution every 2 weeks until the measured weight retention rate of the blood vessel ligation clip after the degradation step is 0, wherein the elapsed time is taken as the degradation time of the blood vessel ligation clip sample.
The specific injection molding process conditions and simulated body fluid degradation experimental results are shown in table 1 below.
TABLE 1 injection Molding test and simulated body fluid degradation test of ligation clip
| Example 2 | Example 3 | Example 4 | Example 5 | Comparative example 1 | Comparative example 2 | Comparative example 3 | |
| Viscosity (dL/g) | 3.48 | 3.62 | 3.36 | 3.85 | 2.18 | 3.28 | 1.98 |
| Mold preheat (. degree. C.) | 50 | 60 | 70 | 70 | 70 | 70 | 50 |
| Injection temperature (. degree.C.) | 190 | 200 | 210 | 210 | 210 | 210 | 190 |
| Injection time(s) | 25 | 30 | 35 | 35 | 35 | 35 | 25 |
| Temperature of Heat treatment (. degree.C.) | 40 | 50 | 60 | 50 | 60 | 60 | 40 |
| Heat treatment time (h) | 2 | 3 | 4 | 5 | 4 | 4 | 2 |
| Whether or not to shape | Is that | Is that | Is that | Is that | Whether or not | Is that | Whether or not |
| Degradation time (moon) | 4 | 5 | 6 | 8 | * | 10 | * |
*: since the material was not formable, no simulated body fluid degradation test was performed.
As shown in Table 1, the blended materials prepared according to the molar ratio of the invention can be prepared and molded according to the injection molding process of the invention, and the degradation rate of the molded U-shaped ligation clip is adjustable.
Application example 2
Cell compatibility testing of the blends: the polyglycolide and polytrimethylene carbonate blends prepared in examples 2 to 5 and comparative examples 1 to 3 were respectively hot-pressed into a flat film with an average thickness of 100 by a flat fluidized bed at 115 ℃ and 10MPa, then the compact film was cut into small disks with a diameter of 15mm by a punch, the small disks were sequentially washed with tap water and secondary distilled water, and then placed in a medical alcohol container for 24 hours, and after being taken out, the small disks were rinsed three times with sterilized triple distilled water to prepare the polyglycolide and polytrimethylene carbonate blendsThe plate was fixed to the bottom of a 24-well tissue culture plate with the air side facing up and sterilized by irradiation with ultraviolet light for 6 hours. To the sterilized 24-well tissue culture plates, 1mL of cell suspension (1X 10) was added per well5one/mL), 5% CO at 37 ℃2And culturing for a certain time in an incubator with saturated humidity, observing the cell morphology by using a fluorescence inverted microscope, removing the culture solution by using a micropipette, washing away the unattached cells by using a buffer solution, adding pancreatin to digest the cells on the polymer membrane, counting, and calculating the cell attachment rate. The results show that: the cell adhesion rates in 4 hours are respectively 38%, 40%, 48%, 41%, 28% and 27%, the cell adhesion rates in 25% and 24 hours are respectively 86%, 87%, 92%, 88%, 65%, 66% and 61%, the cell number is obviously increased, and the cell is divided and proliferated on the surface of the material and rapidly increased. In vitro culture shows that the blend of polyglycolide and polytrimethylene carbonate has good cell compatibility.
Application example 3
Coagulation test of ligation clip:
PT prothrombin time assay: adding excessive calcium-containing tissue thromboplastin into the plasma to be detected, activating the blood coagulation factor X to be Xa by the recalcified plasma in the presence of the tissue factor, converting prothrombin into thrombin, converting fibrinogen into insoluble fibrin by the thrombin, and measuring the time required for coagulation, namely the Prothrombin Time (PT) of the plasma to be detected.
TT thrombin time determination: adding a proper amount of thrombin solution into the plasma to be detected, converting fibrinogen into insoluble fibrin, and measuring the time required for coagulation, namely the Thrombin Time (TT) of the plasma to be detected.
APTT activated partial thromboplastin time assay: adding partial thromboplastin solution into the plasma to be detected, converting fibrinogen into insoluble fibrin in the presence of calcium ions, and measuring the time required for coagulation, namely the Activated Partial Thromboplastin Time (APTT) of the plasma to be detected.
The vascular ligation clip samples to be tested were cut into small pieces and placed into plastic test cassettes for testing in COATRON TECOIV PLUS (TECO Inc., German).
The blood coagulation test was performed on the injection-molded ligation clips of the polyglycolide and polytrimethylene carbonate blends prepared in examples 2 to 5 and comparative example 2 according to the above-described method, and the results are shown in table 2.
TABLE 2 ligation clip coagulation test
| Sample (I) | PT(s) | TT(s) | APTT(s) |
| Fresh healthy blood plasma | 36.64 | 16.21 | 93.82 |
| Example 2 | 32.56 | 14.36 | 91.86 |
| Example 3 | 31.42 | 14.12 | 91.04 |
| Example 4 | 30.12 | 13.05 | 90.13 |
| Example 5 | 33.38 | 14.89 | 91.32 |
| Comparative example 2 | 35.12 | 15.55 | 93.36 |
As can be seen from Table 2, the PT, TT and APTT times for healthy plasma were 36.64 seconds, 16.21 seconds and 93.82 seconds, respectively. The PT, TT and APTT time of the plasma on the ligation clip formed by injection molding of the mixture of polyglycolide and polytrimethylene carbonate with different proportions is shorter than that of blank plasma, and the plasma has a certain procoagulant effect; as the material comes into contact with blood, the surface of the material will rapidly adsorb proteins, followed by adhesion of platelets and activation of the coagulation pathway, ultimately leading to coagulation. The surface finish, surface wettability, and surface charge of the material can all affect coagulation. The blend residence-formed blood vessel ligation clip prepared according to the molar ratio of the invention can attract protein, improve the adhesion of blood platelets at the broken end of the blood vessel, promote the coagulation of blood at the broken end of the blood vessel, and can seal the broken end of the blood vessel more quickly, thereby achieving the purpose of shortening the hemostasis time.
Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that changes, modifications, substitutions and alterations can be made in these embodiments without departing from the principles and spirit of the invention, the scope of which is defined in the appended claims and their equivalents.
Claims (7)
1. A U-shaped tubular tissue ligation clamp with a double-layer structure is characterized by comprising an inner clamp and an outer clamp, wherein the outer clamp is of a U-shaped opening structure and is made of polyglycolide; the inner clip is in a U-shaped opening structure and is made of a blend of polyglycolide and polytrimethylene carbonate; the inner clamp and the outer clamp are provided with anti-falling parts, and the anti-falling parts comprise T-shaped guide strips arranged on the inner side plane of the outer clamp and clamping grooves which are arranged on the outer side plane of the inner clamp and are matched with the T-shaped guide strips;
the preparation method of the double-layer U-shaped tubular tissue ligation clip comprises the following steps:
s1 preparation of raw materials
(a) Preparing polyglycolide:
putting a certain amount of glycolide into a reaction kettle, adding a stannous octoate catalyst with the mass concentration of 0.01%, setting the reaction temperature to be 150-;
(b) preparation of polytrimethylene carbonate:
adding a certain amount of hexahydric cyclic trimethylene carbonate monomer into a reaction kettle, adding a stannous octoate catalyst with the mass concentration of 0.01%, preparing polytrimethylene carbonate through ring-opening polymerization under the vacuum or high-pressure condition, setting the reaction temperature at 150 ℃ and 180 ℃, reacting for 3-5h, and then refluxing, purifying and granulating to obtain a product, wherein the product is sealed and stored;
(c) preparation of polyglycolide and polytrimethylene carbonate blends:
blending and extruding the polyglycolide prepared in the step and the polytrimethylene carbonate according to the mass ratio of 90: 10-70: 30, and granulating to obtain a product, and sealing and storing the product;
s2, molding the double-layer U-shaped tubular tissue ligation clamp by injection molding or compression molding;
the compression molding temperature is 225 ℃;
the injection molding conditions comprise that the mold preheating temperature is 50-70 ℃, the injection molding temperature is 190-210 ℃ and the injection molding period is 25-35s, and then the injection molded U-shaped tubular tissue ligation clip is subjected to heat treatment;
s3, sterilizing and packaging.
2. The double-layered U-shaped tubular tissue ligation clip according to claim 1, wherein the top end surface width of the T-shaped bar is smaller than the width of the outer clip.
3. The double-layered U-shaped tubular tissue ligating clip of claim 1 wherein said inner clip width is the same as said outer clip width.
4. The U-shaped tubular tissue ligating clip of claim 1, wherein polyglycolide, polytrimethylene carbonate and blends of polyglycolide and polytrimethylene carbonate are granulated in step S1 to obtain granules with a diameter of 1.5-2mm and a length of 3 mm.
5. The U-shaped tubular tissue ligating clip of claim 1, wherein the polyglycolide and the polytrimethylene carbonate obtained in step S1 have viscosity ranges of 1.2-3.5dL/g and melt index of 25-65g/10min, respectively.
6. The U-shaped tubular tissue ligating clip of claim 1, wherein the heat treatment in step S2 is performed at a temperature of 40-60 ℃ for 2-5 hours.
7. The double-layered U-shaped tubular tissue ligating clip according to claim 1, wherein said sterilization means in step S3 is irradiation sterilization.
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| US5306283A (en) * | 1992-06-30 | 1994-04-26 | American Cyanamid Company | Two-part surgical ligation clip |
| CN201831920U (en) * | 2010-05-20 | 2011-05-18 | 仁齐企业有限公司 | Improved structure of artery clamp |
| CN201958948U (en) * | 2011-03-04 | 2011-09-07 | 付吉东 | Novel vascular clamp |
| CN205322412U (en) * | 2015-12-24 | 2016-06-22 | 安瑞医疗器械(杭州)有限公司 | Controllable hemostatic clamp that drops |
| CN107137755A (en) * | 2017-06-07 | 2017-09-08 | 浙江微度医疗器械有限公司 | A kind of hemostatic ligation clip that can quickly absorb |
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