CN111228581A - Implantable regeneration membrane for neurosurgery - Google Patents
Implantable regeneration membrane for neurosurgery Download PDFInfo
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- CN111228581A CN111228581A CN202010032233.5A CN202010032233A CN111228581A CN 111228581 A CN111228581 A CN 111228581A CN 202010032233 A CN202010032233 A CN 202010032233A CN 111228581 A CN111228581 A CN 111228581A
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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
- A61L31/043—Proteins; Polypeptides; Degradation products thereof
- A61L31/044—Collagen
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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
- A61L31/02—Inorganic materials
- A61L31/022—Metals or alloys
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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
- A61L31/042—Polysaccharides
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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
- A61L31/043—Proteins; Polypeptides; Degradation products thereof
- A61L31/045—Gelatin
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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
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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
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
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- Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Surgery (AREA)
- Vascular Medicine (AREA)
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- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
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- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
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- Chemical Kinetics & Catalysis (AREA)
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Abstract
The invention discloses an implantable regenerative membrane for neurosurgery, which is of a double-layer membrane structure and is respectively a collagen membrane and a pure zinc membrane, wherein the collagen membrane and the pure zinc membrane are connected through biological fibers with longer degradation time, so that the double-layer membrane is ensured not to generate a split fault. When the regeneration membrane is applied to the artificial dura mater used in neurosurgery, the protective effect of the natural dura mater on brain tissues is restored to the maximum extent, and the two main component substances of the regeneration membrane, namely collagen and zinc, belong to substances which are easy to obtain and low in price, so that the economic cost is reduced to a great extent, and the regeneration membrane is worthy of being popularized in a large range.
Description
Technical Field
The invention belongs to the technical field of medical materials, and particularly relates to an implantable regeneration membrane for neurosurgery.
Background
At present, the dura mater is required to be implanted manually in neurosurgery, and the dura mater of a human is a thick and tough double-layer membranous tissue on the surface of a brain tissue and is tightly attached to the inner side of a skull, so that the dura mater is an important barrier for protecting the brain and preventing cerebrospinal fluid from communicating with the outside. Artificial Dura Mater (Artificial Dura Mater) is a substitute for human meninges made of biological materials, and is used for repairing Dura Mater or meninges defect caused by craniocerebral and spinal cord injury, tumor and other craniocerebral diseases, and preventing serious complications such as cerebrospinal fluid leakage, intracranial infection, brain swelling, brain adhesion and scars so as to restore the integrity of the meninges.
There are many varieties of clinically available guided tissue regeneration membranes, which are classified into two main categories according to whether they can be absorbed: absorbable films and non-absorbable films. The absorbable membrane is mainly an animal collagen membrane which has good biocompatibility and tissue attachment, but has insufficient mechanical properties, low strength in a wet state, insufficient strength to maintain the space of a bone regeneration area, and excessively high degradation speed of collagen in vivo; the non-absorbable membrane is represented by a polytetrafluoroethylene membrane, needs to be taken out through a secondary operation when in use, brings great pain to patients, cannot be used for tissue regeneration of large defect areas due to no biological activity, and limits the range of clinical use.
Disclosure of Invention
In order to solve the problems that the mechanical property is poor and the strength is too low due to the fact that an absorbable membrane is used singly, and the absorbable membrane is used singly, so that the absorbable membrane has no bioactivity and cannot be used for tissue regeneration of a large defect area in the prior art, the invention provides an implantable regeneration membrane for neurosurgery, which is realized by the following technical scheme:
an implantable regeneration membrane for neurosurgery, which is a double-layer membrane structure comprising a collagen membrane and a pure zinc membrane, wherein the collagen membrane and the pure zinc membrane are woven and connected through biological fibers.
Furthermore, the thickness of the pure zinc film is 1-15 μm.
Further, the thickness of the collagen film is 1-15 μm.
Further, the raw material of the biological fiber is selected from one or more synthetic absorbable polymer materials, one or more natural polymer materials, or a combination thereof.
Further, the synthetic absorbable polymer material comprises polylactic acid, polyglycolic acid, polycaprolactone, polylactic-glycolic acid copolymer, polylactic-caprolactone copolymer and polyethylene glycol copolymer.
Further, the natural polymer material comprises gelatin, collagen, silk fibroin, chitosan, modified chitosan, hyaluronic acid, alginate, fibrin and cellulose.
Further, the regenerated membrane is prepared by the following steps:
step S1: removing fat and fascia from fresh pigskin or tendon, cutting into slices of less than 5mm, removing blood, degreasing, rinsing with distilled water, and air drying;
step S2: putting the pretreated pigskin or tendon into a flask, respectively adding enzyme and acetic acid solution for hydrolysis, controlling the temperature to be about 4 ℃, slowly stirring for 3 days, then centrifuging by using a high-speed refrigerated centrifuge, and taking supernatant solution to obtain crude collagen solution;
step S3: slowly adding sodium hydroxide solution into the crude collagen solution to adjust the pH value to 7, freezing and centrifuging to remove precipitates, adding sodium chloride solid into the residual solution, grinding into powder, slowly stirring, standing at 4 ℃ overnight for preservation, centrifuging to obtain precipitates, dissolving again by using dilute acetic acid, filling the dissolved solution into a dialysis bag, dialyzing for 1d by using acetic acid solution with the mass fraction of 0.1%, and dialyzing by using distilled water to obtain the final collagen aqueous solution;
step S4: drying the collagen aqueous solution obtained in the step S3, and processing the dried collagen aqueous solution into a collagen film with the thickness of 1-15 microns;
step S5: selecting pure zinc to prepare a zinc film with the thickness of 1-15 mu m;
step S6: ultrasonically cleaning the zinc film obtained in the step S5 by using acetone, absolute ethyl alcohol and deionized water in sequence, and drying at 25 ℃;
step S7: and (3) physically or chemically crosslinking the collagen membrane obtained in the step (S4) and the zinc membrane obtained in the step (S6) through biological fibers to obtain a double-layer membrane structure.
Further, in the step S2, the centrifugal speed is 4000 r.min-1。
Further, in the step S3, the concentration of the sodium hydroxide solution is 6 mol. L-1. The invention has the beneficial effects that: the invention combines collagen and zinc into a double-layer film, so that the mechanical strength of the regenerated film is better improved than that of the regenerated film only using a collagen film, and simultaneously, the problem of rejection increase caused by no biological activity when only using a zinc film is reduced, and the regenerated film of the inventionWhen the collagen and the zinc are applied to the artificial dura mater used in neurosurgery, the protective effect of natural dura mater on brain tissue is restored to the maximum extent, and the two main composition substances of the collagen and the zinc belong to substances which are easy to obtain and low in price, so that the economic cost is reduced to a great extent, and the collagen and the zinc are worthy of large-scale popularization.
Detailed Description
Example 1
Step S1: removing fat and fascia from 500g of fresh pigskin, cutting into slices of 3mm by using a slicer, removing blood, degreasing, rinsing with distilled water, and airing for later use;
step S2: weighing the pretreated pigskin, putting the pigskin into a flask, respectively adding 5 units of pepsin and acetic acid solution for hydrolysis, then slowly stirring for 3 days at a temperature of about 4 ℃ by using a temperature-controlled magnetic stirrer, and then centrifuging by using a high-speed refrigerated centrifuge at a centrifugation speed of 4000 r.min-1Centrifuging and taking the supernatant to obtain a crude collagen solution;
step S3: slowly adding 6 mol.L into the crude collagen solution-1Adjusting the pH value of a sodium hydroxide solution to 7, removing precipitates by using a high-speed refrigerated centrifuge for refrigerated centrifugation, adding sodium chloride solid into the residual solution, grinding the powder into fine powder, slowly stirring the powder, standing the mixture at 4 ℃ for overnight storage, centrifuging the mixture to obtain precipitates, dissolving the precipitates again by using dilute acetic acid, filling the dissolved solution into a dialysis bag, dialyzing the solution for 1d by using an acetic acid solution with the mass fraction of 0.1 percent, and dialyzing the solution by using distilled water to obtain a final collagen aqueous solution;
step S4: drying the collagen aqueous solution obtained in the step S3, and processing the dried collagen aqueous solution into a collagen film with the thickness of 7 mu m;
step S5: pure zinc is selected to be made into a zinc film with the thickness of 10 mu m;
step S6: ultrasonically cleaning the zinc film obtained in the step S5 by using acetone, absolute ethyl alcohol and deionized water in sequence, and drying at 25 ℃;
step S7: and (3) physically crosslinking the collagen film obtained in the step S4 and the zinc film obtained in the step S6 through gelatin to obtain a double-layer film structure.
Example 2
Step S1: removing fat and fascia from 500g of fresh pigskin, cutting into slices of 3mm by using a slicer, removing blood, degreasing, rinsing with distilled water, and airing for later use;
step S2: weighing the pretreated pigskin, putting the pigskin into a flask, respectively adding 5 units of pepsin and acetic acid solution for hydrolysis, then slowly stirring for 3 days at a temperature of about 4 ℃ by using a temperature-controlled magnetic stirrer, and then centrifuging by using a high-speed refrigerated centrifuge at a centrifugation speed of 4000 r.min-1Centrifuging and taking the supernatant to obtain a crude collagen solution;
step S3: slowly adding 6 mol.L into the crude collagen solution-1Adjusting the pH value of a sodium hydroxide solution to 7, removing precipitates by using a high-speed refrigerated centrifuge for refrigerated centrifugation, adding sodium chloride solid into the residual solution, grinding the powder into fine powder, slowly stirring the powder, standing the mixture at 4 ℃ for overnight storage, centrifuging the mixture to obtain precipitates, dissolving the precipitates again by using dilute acetic acid, filling the dissolved solution into a dialysis bag, dialyzing the solution for 1d by using an acetic acid solution with the mass fraction of 0.1 percent, and dialyzing the solution by using distilled water to obtain a final collagen aqueous solution;
step S4: drying the collagen aqueous solution obtained in the step S3, and processing the dried collagen aqueous solution into a collagen film with the thickness of 10 mu m;
step S5: pure zinc is selected to be made into a zinc film with the thickness of 12 mu m;
step S6: ultrasonically cleaning the zinc film obtained in the step S5 by using acetone, absolute ethyl alcohol and deionized water in sequence, and drying at 25 ℃;
step S7: and (4) physically crosslinking the collagen film obtained in the step (S4) and the zinc film obtained in the step (S6) through polycaprolactone to obtain a double-layer film structure.
Example 3
Step S1: removing fat and fascia from 500g of fresh pigskin, cutting into slices of 3mm by using a slicer, removing blood, degreasing, rinsing with distilled water, and airing for later use;
step S2: weighing the pretreated pigskin, putting the pigskin into a flask, respectively adding 5 units of pepsin and acetic acid solution for hydrolysis, and then using a temperature-controlled magnetic forceSlowly stirring at 4 deg.C for 3d, and centrifuging at 4000r min-1Centrifuging and taking the supernatant to obtain a crude collagen solution;
step S3: slowly adding 6 mol.L into the crude collagen solution-1Adjusting the pH value of a sodium hydroxide solution to 7, removing precipitates by using a high-speed refrigerated centrifuge for refrigerated centrifugation, adding sodium chloride solid into the residual solution, grinding the powder into fine powder, slowly stirring the powder, standing the mixture at 4 ℃ for overnight storage, centrifuging the mixture to obtain precipitates, dissolving the precipitates again by using dilute acetic acid, filling the dissolved solution into a dialysis bag, dialyzing the solution for 1d by using an acetic acid solution with the mass fraction of 0.1 percent, and dialyzing the solution by using distilled water to obtain a final collagen aqueous solution;
step S4: drying the collagen aqueous solution obtained in the step S3, and processing the dried collagen aqueous solution into a collagen film with the thickness of 3 mu m;
step S5: pure zinc is selected to be made into a zinc film with the thickness of 4 mu m;
step S6: ultrasonically cleaning the zinc film obtained in the step S5 by using acetone, absolute ethyl alcohol and deionized water in sequence, and drying at 25 ℃;
step S7: and (3) physically crosslinking the collagen membrane obtained in the step (S4) and the zinc membrane obtained in the step (S6) through hyaluronic acid to obtain a double-layer membrane structure.
The above description is only an embodiment of the present invention, but the scope of the present invention is not limited thereto, and any changes or substitutions that are not thought of through the inventive work should be included in the scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope defined by the claims.
Claims (9)
1. An implantable regeneration membrane for neurosurgery, which is characterized in that the regeneration membrane is of a double-layer membrane structure and is respectively a collagen membrane and a pure zinc membrane, and the collagen membrane and the pure zinc membrane are woven and connected through biological fibers.
2. The implantable regeneration membrane for neurosurgery according to claim 1, wherein said collagen membrane has a thickness of 1 to 15 μm.
3. The implantable regeneration membrane for neurosurgery according to claim 1, wherein said pure zinc membrane has a thickness of 1 to 15 μm.
4. The implantable regeneration membrane according to claim 1, wherein said bio-fibers are selected from one or more synthetic absorbable polymer materials, one or more natural polymer materials, or a combination thereof.
5. The implantable regeneration membrane for neurosurgery according to claim 4, wherein said synthetic absorbable high molecular material comprises polylactic acid, polyglycolic acid, polycaprolactone, poly (lactic-co-glycolic acid), poly (lactic-co-caprolactone), poly (ethylene glycol).
6. The implantable regeneration membrane for neurosurgery according to claim 4, wherein said natural polymer material comprises gelatin, collagen, silk fibroin, chitosan, modified chitosan, hyaluronic acid, alginate, fibrin, cellulose.
7. The implantable regeneration membrane for neurosurgery according to any one of claims 1 to 6, characterized in that it is prepared in particular by:
step S1: removing fat and fascia from fresh pigskin or tendon, cutting into slices of less than 5mm, removing blood, degreasing, rinsing with distilled water, and air drying;
step S2: putting the pretreated pigskin or tendon into a flask, respectively adding enzyme and acetic acid solution for hydrolysis, controlling the temperature to be about 4 ℃, slowly stirring for 3 days, then centrifuging by using a high-speed refrigerated centrifuge, and taking supernatant solution to obtain crude collagen solution;
step S3: slowly adding sodium hydroxide solution into the crude collagen solution to adjust the pH value to 7, freezing and centrifuging to remove precipitates, adding sodium chloride solid into the residual solution, grinding into powder, slowly stirring, standing at 4 ℃ overnight for preservation, centrifuging to obtain precipitates, dissolving again by using dilute acetic acid, filling the dissolved solution into a dialysis bag, dialyzing for 1d by using acetic acid solution with the mass fraction of 0.1%, and dialyzing by using distilled water to obtain the final collagen aqueous solution;
step S4: drying the collagen aqueous solution obtained in the step S3, and processing the dried collagen aqueous solution into a collagen film with the thickness of 1-15 microns;
step S5: selecting pure zinc to prepare a zinc film with the thickness of 1-15 mu m;
step S6: ultrasonically cleaning the zinc film obtained in the step S5 by using acetone, absolute ethyl alcohol and deionized water in sequence, and drying at 25 ℃;
step S7: and (3) physically or chemically crosslinking the collagen membrane obtained in the step (S4) and the zinc membrane obtained in the step (S6) through biological fibers to obtain a double-layer membrane structure.
8. The implantable regeneration membrane for neurosurgery according to claim 7, wherein in said step S2, the centrifugation speed is 4000 r-min-1。
9. The implantable regeneration membrane for neurosurgery according to claim 7, wherein in said step S3, the concentration of sodium hydroxide solution is 6 mol-L-1。
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| CN202010032233.5A CN111228581A (en) | 2020-01-13 | 2020-01-13 | Implantable regeneration membrane for neurosurgery |
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| CN202010032233.5A CN111228581A (en) | 2020-01-13 | 2020-01-13 | Implantable regeneration membrane for neurosurgery |
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