CN106256384B - A kind of biological sticking patch and preparation method - Google Patents
A kind of biological sticking patch and preparation method Download PDFInfo
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- CN106256384B CN106256384B CN201610756478.6A CN201610756478A CN106256384B CN 106256384 B CN106256384 B CN 106256384B CN 201610756478 A CN201610756478 A CN 201610756478A CN 106256384 B CN106256384 B CN 106256384B
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- sticking patch
- collagen
- middle layer
- layer
- biological sticking
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- 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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/04—Macromolecular materials
- A61L31/06—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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/04—Macromolecular materials
- A61L31/043—Proteins; Polypeptides; Degradation products thereof
- A61L31/044—Collagen
-
- 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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/04—Macromolecular materials
- A61L31/048—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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/146—Porous materials, e.g. foams or sponges
Abstract
The present invention discloses a kind of biological sticking patch, and the sticking patch includes: for providing the middle layer that mechanics is supported to the biological sticking patch；It is connect with the middle layer, the antiblocking layers for preventing histoorgan adhesion positioned at middle layer side；It is connect with the middle layer, the bio-regeneration material layer for promoting soft tissue regeneration and inhibiting scar positioned at the middle layer other side.The invention also discloses the preparation methods of the biological sticking patch, since the method for the present invention has physics tessellation, thus each layer of sticking patch can be made to combine more closely, be not easy to be layered；It is reinforced without by way of final step hot pressing；Avoid the degradation of degradable poly ester material caused by heating；Sponge structure is formed additionally, due to lyophilized technique is taken, material is softer；There is good submissive performance.
Description
Technical field
The present invention relates to medical instruments fields to be implanted into class material.More particularly, to a kind of biological sticking patch and its preparation side
Method.
Background technique
Many surgical operations use biological sticking patch at present, especially being most widely used with hernia sticking patch and basin bottom sticking patch, make
It is to carry out reinforcing and bridging to damaged or weak soft tissue with the purpose of sticking patch.Biological sticking patch uses comparative maturity at present
Be using sticking patch and the sticking patch worked out as raw material spinning of PP that ePTFE is raw material puffed processing, two kinds of sticking patch are clinically
It has used for many years.But some drawbacks for passing through prolonged two kinds of sticking patch of clinical use also gradually show, and are primarily due to flexible
Property it is poor, be implanted into human body after foreign body sensation it is stronger, secondly because the difference with surrounding tissue mechanics compliance in vivo, can gradually draw
It plays the fiberization of surrounding tissue and gradually forms fibrous capsule, by prolonged use, product is for adjacent tissue device
The erosion increased risk of official, and ePTFE product is also easy to cause to infect, and needs second operation to take out after infection.
Corresponding in order to solve the problems, such as, ePTFE product is gradually substituted, and safer PP product is produced
It is worked out at thinner fiber, product is made to become soft as far as possible.Other company has also attempted some new materials, such as uses
PET material spinning carries out establishment biological sticking patch.These are improved solves the problems, such as product flexibility to a certain extent, but due to
Non-degradable material itself and the mechanical compatibility and biocompatibility of tissue are all poor, so simple non-degradable
Synthetic material still easily causes adhesion between histoorgan and more in the soft tissue repairing closed on for histoorgan
Serious inflammatory reaction, so the problem of not can solve more biological sticking patch in use.
Patent WO2009079271A2 describes the three-layer composite structure mesh sheet of Johson & Johnson's exploitation, in original PP material base
Prevented adhesion PDS material respectively on plinth and had the ORC material of certain power of regeneration with being compounded with, three layers compound solve respectively it is anti-sticking
The problem of even and portion of tissue regenerates, but the biological sticking patch is prepared by hot pressing complex method, easily causes the sliding of interlayer,
And lead to compound failure, simultaneously because Material cladding multilayer easily causes after implanting so that the material softness is poor
Foreign body sensation.
Patent CN102217981A proposes a kind of three-layer composite structure mesh sheet and its preparation, on original PP mesh sheet basis
It is upper respectively with polyester material and three layers of natural polymer it is compound, polyester material play the role of it is certain prevent adhesion, can be used for abdomen
Operation is isolated in intracavitary implantation, and natural polymer has good bio-regeneration ability, can induce soft tissue regeneration.But it is this
The natural macromolecular material mentioned in technology such as hyaluronic acid, the degradation such as chitosan is too fast, and the regeneration of peritonaeum needs are longer
Time.Other natural macromolecular materials mentioned, such as collagen and gelatin be by that would generally become very hard after drying and hot pressing,
It is easy to cause tissue to scratch, and causes foreign body sensation.
In addition, above-mentioned sticking patch product is there is also introducing noxious material due to chemical reaction, since existing sticking patch exists
It is easy layering, flexibility is not good enough and easily causes adhesion, and the technique price prepared yet more expensive problem.Spy is directed to existing skill
Art there are the problem of, propose the present invention.The present invention provides mechanical support by being located at the polypropylene layer of middle layer, using collagen layer
Freeze drying technology, the collagen-based materials of freeze-drying make material itself can be than high temperature drying or hot-forming sticking patch power since layer is spongy
It is more preferable to learn flexibility.Sticking patch is entered in the solution of polyester material after synthesis collagen layer, since the collagen layer of freeze-drying is with certain
Hole form physics so the polyester liquid made can enter in collagen freeze-drying layer and inlay and ensure that binding force, in addition polyester material
Material can choose the flexibility of more soft polyester material retained product.
Summary of the invention
It is an object of the present invention to provide a kind of biological sticking patch and its preparation, biological sticking patch proposed by the present invention has
The good effect of preventing adhesion, bootable regeneration, softer and organization mechanics compatibility are good.
In order to achieve the above objectives, the present invention adopts the following technical solutions:
A kind of biological sticking patch, the sticking patch include:
For providing the middle layer that mechanics is supported to the biological sticking patch；
The middle layer is wrapped up to promote soft tissue regeneration and inhibit the bio-regeneration material layer of scar；
Being entrenched among the middle layer and the bio-regeneration material layer prevents preventing adhesion for histoorgan adhesion
Layer.
Further, the middle layer is polypropylene mesh, and the antiblocking layers are biodegradable polyester material, institute
It states bio-regeneration material layer and extracts collagen layer for biology.
Further, the biodegradable polyesters material is in PLA, PLGA, PCL, PGCL, PLCL, PHB, PHBV
One or more.
Further, the intensity of the polypropylene mesh is 20N/cm, and filament diameter is in 0.05-0.2mm.
Further, the biology extracts collagen from pig, ox or horse.
It is a further object to provide a kind of preparation method of biological sticking patch,
This method comprises the following steps:
(1) it prepares biology and extracts collagen solution；
(2) polypropylene mesh is immersed in collagen solution, is then taken out, be freeze-dried, obtain collagen-polypropylene screen
Piece；
(3) biodegradable polyesters material prepared polymer solution is used；
(4) collagen-polypropylene diaphragm is immersed in the polymer solution, polymer solution enters collagen-polypropylene screen
In the hole of piece, decompression or decompression high temperature drying are taken out, the biological sticking patch is obtained；
(5) x ray irradiation x or ethylene oxide irradiation sterilization are carried out to obtained biological sticking patch.
Further, it is 0.5wt%-15wt% that biology described in step (1), which extracts the concentration of collagen solution, prepares biology
Extracting solvent used in collagen solution is one of dimethyl sulfoxide, dimethylformamide, hexafluoroisopropanol and dioxane
Or it is several.
Further, the concentration of step (3) described polymer solution is 1wt%-25wt%, used in prepared polymer solution
Solvent be dimethyl sulfoxide, dimethylformamide, hexafluoroisopropanol, dioxane, chloroform, methylene chloride, acetone, second
One or more of acetoacetic ester, ethyl alcohol, ether and tetrahydrofuran；
Further, the polymer is biodegradable polyester material, is selected from PCL, PGA-PCL copolymer, PLA-PCL
One or more of copolymer, PHB, PHBV.
Further, the intensity of polypropylene mesh described in step (2) is 20N/cm, and filament diameter is in 0.05-0.2mm.
Beneficial effects of the present invention are as follows:
Preparation method of the invention can be such that each layer of sticking patch combines more closely due to there is physics tessellation, no
Easily layering；It is reinforced without by way of final step hot pressing；Avoid degradable poly ester material caused by heating
Degradation；Sponge structure is formed additionally, due to lyophilized technique is taken, material is softer；There is good submissive performance.
The tensile strength of biological sticking patch produced by the present invention be not less than national standard, the biological sticking patch product it is spongy
Structure increases the surface area of product, enhances cell adherence performance, the polyester material of another side for guiding soft tissue regeneration
In the hole for having immersed collagen layer of layer certain depth, physics interconnected is formd after dry and is fitted into, PCL, PLA- are passed through
The softness of the more soft polymer adjustment material such as PCL copolymer, PGA-PCL copolymer, makes product obtain biology
It prevents adhesion and regenerates the performance of induction simultaneously and be combined with each other closely, and simple process.
The collagen-based materials that the present invention applies can with inducing tissue regeneration, so that newly-generated peritonaeum is softer, without
Cause regenerated peritonaeum to belong to scar tissue, foreign body sensation is stronger, and collagen-based materials be widely regarded as one kind can be with rapid induction
The material of regeneration；The dry collagem membrane of heat is more hard, is easy to scratch tissue；Present invention lyophilized collagen adds degradable high score
Sub- technology can form a kind of product of softness, while facilitating application, also reach reparation and regenerated purpose.
Detailed description of the invention
Fig. 1 is biological sticking patch structure chart of the present invention；
Fig. 2 is biological sticking patch sectional view of the present invention；
Fig. 3 is that sponge structure sectional view is lyophilized in biological sticking patch of the present invention.
Specific embodiment
In order to illustrate more clearly of the present invention, the present invention is done further below with reference to preferred embodiments and drawings
It is bright.
Embodiment 1
Prepare biological sticking patch
1. ox heel string extraction collagen is dissolved in hexafluoroisopropanol, the collagen solution that concentration is 5wt% is obtained；
2. polypropylene (PP) mesh sheet is placed in the collagen solution that concentration is 5wt% simultaneously, it is poly- to obtain collagen-for frozen dried
Propylene diaphragm；
Concentration is made in acetone as 10wt%'s 3. PLA-PCL copolymer (70%PLA, 30%PCL copolymer) is dissolved in
Polymer solution；
4. collagen-polypropylene diaphragm is immersed in PLA-PCL copolymer acetone soln, keep PLA-PCL copolymer acetone molten
Liquid enters in collagen-polypropylene diaphragm hole, using low-temperature reduced-pressure technique, obtains the regeneration biological sticking patch that prevents adhesion after dry；
5. pair obtained biological sticking patch carries out radio sterilization.
The biology used in the present embodiment extracts collagenous source in the extract of the skin of pig or ox, bone or tendon.This
It is well combined between each layer of sticking patch of embodiment preparation, cutting is not stratified, and 24 hours are impregnated in 37 DEG C of normal saline solutions not
Layering, and it is sufficiently flexible.
Embodiment 2
1. biology, which is extracted collagen, is dissolved in dioxane, the collagen solution that concentration is 5wt% is obtained；
2. polypropylene (PP) mesh sheet is entered collagen solution, and frozen dried, collagen-PP diaphragm is obtained；
3. PHB is dissolved in ethyl acetate and concentration is made is the polymer solution of wt%；
4. collagen-PP diaphragm is immersed but is not exclusively immersed in PLCL solution, PHB solution is made to enter collagen-PP diaphragm
Hole in, using low-temperature reduced-pressure technique, obtain the regeneration biological sticking patch that prevents adhesion after dry；
5. pair obtained biological sticking patch carries out radio sterilization.
The biology used in the present embodiment extracts collagen as collagen, derives from pigskin.Sticking patch manufactured in the present embodiment is each
Layer between be well combined, cut it is not stratified, impregnated in 37 DEG C of normal saline solutions 24 hours it is not stratified and sufficiently flexible.
Embodiment 3
1. biology, which is extracted collagen, is dissolved in DMSO, the collagen solution that concentration is 5wt% is obtained；
2. polypropylene (PP) mesh sheet is entered collagen solution, and frozen dried, collagen-PP diaphragm is obtained；
3. PLA is dissolved in ethyl alcohol and concentration is made is the polymer solution of wt%；
4. collagen-PP diaphragm is immersed but is not exclusively immersed in PLA solution, PLA solution is made to enter collagen-PP diaphragm
In hole, using low-temperature reduced-pressure technique, the regeneration biological sticking patch that prevents adhesion is obtained after dry；
5. pair obtained biological sticking patch carries out radio sterilization.
The biology used in the present embodiment extracts collagen as ossein, derives from ox bone.Sticking patch manufactured in the present embodiment is each
Layer between be well combined, cut it is not stratified, impregnated in 37 DEG C of normal saline solutions 24 hours it is not stratified and sufficiently flexible.
Obviously, the above embodiment of the present invention be only to clearly illustrate example of the present invention, and not be pair
The restriction of embodiments of the present invention may be used also on the basis of the above description for those of ordinary skill in the art
To make other variations or changes in different ways, all embodiments can not be exhaustive here, it is all to belong to this hair
The obvious changes or variations that bright technical solution is extended out are still in the scope of protection of the present invention.
Claims (2)
1. a kind of biological sticking patch, which is characterized in that the sticking patch includes:
For providing the middle layer that mechanics is supported to the biological sticking patch, the middle layer is polypropylene mesh, the polypropylene
The intensity of mesh sheet is 20N/cm, and filament diameter is in 0.05-0.2mm；
The middle layer is wrapped up to promote soft tissue regeneration and inhibit the bio-regeneration material layer of scar, the bio-regeneration material layer
Collagen layer is extracted for biology, the biology extracts collagen from pig, ox or horse；
The antiblocking layers for preventing histoorgan adhesion being entrenched among the middle layer and the bio-regeneration material layer, it is described
Antiblocking layers be biodegradable polyester material, the biodegradable polyesters material be selected from PLA, PLGA, PCL, PGCL,
One or more of PLCL, PHB, PHBV.
2. the preparation method of biological sticking patch as described in claim 1, which is characterized in that this method comprises the following steps:
(1) it prepares biology and extracts collagen solution, the concentration that the biology extracts collagen solution is 0.5wt%-15wt%, prepares life
It is one in dimethyl sulfoxide, dimethylformamide, hexafluoroisopropanol and dioxane that object, which extracts solvent used in collagen solution,
Kind is several；
(2) polypropylene mesh the biology being immersed in extract in collagen solution, freeze-drying obtains collagen-polypropylene diaphragm,
The intensity of the polypropylene mesh is 20N/cm, and filament diameter is in 0.05-0.2mm；
(3) prepared polymer solution, the concentration of the polymer solution are 1wt%-25wt%, used in prepared polymer solution
Solvent is dimethyl sulfoxide, dimethylformamide, hexafluoroisopropanol, dioxane, chloroform, methylene chloride, acetone, acetic acid
One or more of ethyl ester, ethyl alcohol, ether and tetrahydrofuran；The polymer is biodegradable polyester material, is selected from
One or more of PLA, PLGA, PCL, PGCL, PLCL, PHB, PHBV；
(4) collagen-polypropylene diaphragm is immersed into the polymer solution, taking-up is dried under reduced pressure, or decompression high temperature drying, is obtained
The biological sticking patch；
(5) x ray irradiation x or ethylene oxide irradiation sterilization are carried out to obtained biological sticking patch.
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| CN106256384B true CN106256384B (en) | 2019-11-15 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111407924A (en) * | 2020-04-17 | 2020-07-14 | 南京鼓楼医院 | Composite patch with anisotropic surface and preparation method and application thereof |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107837129A (en) * | 2017-12-16 | 2018-03-27 | 诺迈尔（苏州）医学科技有限公司 | Non-degradable class hernia paster biocompatibility improved method |
| CN108653824A (en) * | 2018-06-08 | 2018-10-16 | 段降龙 | A kind of new bio sticking patch and preparation method thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102217981A (en) * | 2011-05-16 | 2011-10-19 | 北京天助畅运医疗技术股份有限公司 | Multi-layer hernia repairing patch and preparation method thereof |
| CN102526812A (en) * | 2012-02-02 | 2012-07-04 | 北京博恩康生物科技有限公司 | Biodegradable multi-layered hernia repairing sheet and preparation methods thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20100247598A1 (en) * | 2009-03-31 | 2010-09-30 | Shetty Dhanuraj S | Thick foams for biomedical application and methods of making |
| US9636109B2 (en) * | 2009-07-22 | 2017-05-02 | Wisconsin Alumni Research Foundation | Biologically active sutures for regenerative medicine |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102217981A (en) * | 2011-05-16 | 2011-10-19 | 北京天助畅运医疗技术股份有限公司 | Multi-layer hernia repairing patch and preparation method thereof |
| CN102526812A (en) * | 2012-02-02 | 2012-07-04 | 北京博恩康生物科技有限公司 | Biodegradable multi-layered hernia repairing sheet and preparation methods thereof |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111407924A (en) * | 2020-04-17 | 2020-07-14 | 南京鼓楼医院 | Composite patch with anisotropic surface and preparation method and application thereof |
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| CN106256384A (en) | 2016-12-28 |
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