CN106267347B - Basin bottom biological sticking patch and preparation method thereof - Google Patents
Basin bottom biological sticking patch and preparation method thereof Download PDFInfo
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- CN106267347B CN106267347B CN201610678065.0A CN201610678065A CN106267347B CN 106267347 B CN106267347 B CN 106267347B CN 201610678065 A CN201610678065 A CN 201610678065A CN 106267347 B CN106267347 B CN 106267347B
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- YWIVKILSMZOHHF-QJZPQSOGSA-N sodium;(2s,3s,4s,5r,6r)-6-[(2s,3r,4r,5s,6r)-3-acetamido-2-[(2s,3s,4r,5r,6r)-6-[(2r,3r,4r,5s,6r)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2- Chemical compound [Na+].CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 YWIVKILSMZOHHF-QJZPQSOGSA-N 0.000 claims description 5
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Classifications
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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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
- A61L27/3604—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
- A61L27/3633—Extracellular matrix [ECM]
-
- 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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
- A61L27/3641—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the site of application in the body
- A61L27/3645—Connective tissue
- A61L27/365—Bones
-
- 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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
- A61L27/3683—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
- A61L27/3687—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment characterised by the use of chemical agents in the treatment, e.g. specific enzymes, detergents, capping agents, crosslinkers, anticalcification 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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
- A61L27/3683—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
- A61L27/3691—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment characterised by physical conditions of the treatment, e.g. applying a compressive force to the composition, pressure cycles, ultrasonic/sonication or microwave treatment, lyophilisation
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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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
- A61L27/3683—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
- A61L27/3695—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment characterised by the function or physical properties of the final product, where no specific conditions are defined to achieve this
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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
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants
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- Epidemiology (AREA)
- Public Health (AREA)
- Dermatology (AREA)
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- Transplantation (AREA)
- Veterinary Medicine (AREA)
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- Urology & Nephrology (AREA)
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- Vascular Medicine (AREA)
- Prostheses (AREA)
- Materials For Medical Uses (AREA)
Abstract
The present invention provides a kind of basin bottom biological sticking patch and preparation method thereof.The present invention is low using immunogenicity, good biocompatibility and biodegradable natural acellular matrix material carry out compound and punching processing and prepare basin bottom sticking patch, material is gradually degraded after implanting, by compound and cheesing techniques, while guaranteeing internal mechanical support, reduce the absolute magnitude of implantation material, reduce immune risk, the compliance between implantation material and basin bottom soft tissue is improved simultaneously, and the final Regeneration and Repair for promoting pelvic floor tissue reinforces soft tissue fascia and achievees the purpose that treat POP.
Description
Technical Field
The invention relates to the field of medical biomaterials, in particular to a pelvic floor biological patch and a preparation method thereof.
Background
Female Pelvic Floor Dysfunction (PFD) is mainly manifested as Pelvic Organ Prolapse (POP), Stress Urinary Incontinence (SUI), and the like, and it has been reported that 50% of women who have passed through have pelvic floor dysfunction in various degrees. With the development of social economy, the aging trend of population and the improvement of requirements of people on health and life quality, the incidence of pelvic cavity dysfunction is increased year by year, and the pelvic cavity dysfunction becomes a gynecological problem which seriously affects the health and life quality of middle-aged and old women. Pelvic dysfunction patients have an unnecessary degree of pelvic floor connective tissue weakness or anatomical structure change, and surgical operation is the main method for treating serious pelvic floor dysfunction, and mainly comprises various tissue and physiological structure repair and suspension operations. Often, materials such as patches are implanted to enhance the surgical effect.
Currently, a patch made of a synthetic material represented by polypropylene (PP) is mainly used clinically for the treatment of PFD. The patch is firstly applied to hernia treatment, achieves certain success, effectively reduces the recurrence rate of hernia, and is gradually applied to operations for treating POP and SUI, but due to the characteristics of the raw materials of the patch, the patch gradually causes various problems such as infection, urethra erosion and other complications in the clinical use process. Although some research in recent years has been directed to improving the patch by enlarging the mesh of the patch, etc., since polypropylene itself is a synthetic polymer and is not degraded in the body, it is easy to generate irritation of foreign materials, and risks of aging, hardening, becoming brittle, friction, displacement, etc. in the body are always present in use.
Several studies have recently introduced degradable materials into the preparation of pelvic floor patches, where acellular matrix materials have attracted considerable attention with their unique advantages. Compared with the traditional material, the biological patch has better biocompatibility, is gradually degraded after being implanted into a body, induces and regenerates new tissues like fascia or ligament of the original tissues, keeps the original mechanical tension and contractility of the tissues, has certain anti-infection performance and has better application prospect.
However, since the biological patch is mostly derived from biological membranes (such as small intestine submucosa, bladder submucosa and pericardium), and most of the biological membranes are fascia tissues or membranous materials, the biological patches are still membranous materials after a series of treatments such as decellularization, and the prepared patch is flat, although the biological patches can be gradually metabolized and promote the regeneration of peripheral defective tissues after being implanted into the body, the patch is usually implanted into the periphery of the vaginal wall in a flat state, the peripheral tissues are guided to be gradually attached to the patch and regenerated into a smooth tissue along the patch, so that the original fold structure of the vaginal inner wall is lost after the patch is implanted. Regeneration of the original tissue as it is not completely achieved. Meanwhile, although the biological patch has small immunogenicity after multiple treatments and is not easy to cause tissue rejection and immunoreaction, the absolute implantation amount of an implanted product is more than that of a mesh sheet due to the compactness of the whole membrane material implantation, and the risk of immunoreaction can also be increased; thus, the introduction of as few implants as possible avoids immunogenic risks while ensuring that the tissue regeneration is adequately guided and that the patch provides sufficient mechanical support.
Disclosure of Invention
The invention aims to provide a novel pelvic floor biological patch and a preparation method thereof.
In order to realize the purpose of the invention, the invention provides a preparation method of a pelvic floor biological patch, which comprises the following steps:
1) taking natural extracellular matrix subjected to antigen removal treatment as a material, placing 2-10 (preferably 4) layers of single materials with the same specification in a staggered or parallel overlapping mode, tightly attaching the layers by using a clamp, or firmly attaching the layers together by using an adhesive or a suture line to prepare a rectangular, square, trapezoidal, circular or irregularly-shaped preformed sheet material;
2) punching circular or parallelogram holes (FIG. 1 and FIG. 3A) on the preformed sheet material, wherein each hole has an area of 0.05cm2-1cm2The distribution density of the holes is 0.8-10/cm2The area of the perforated part accounts for more than 12 percent of the total area of the preformed sheet material; or,
reserving a cross-shaped strip which has the width of H and penetrates through the whole sheet material at the central point of the preformed sheet material, wherein holes are not punched on the cross-shaped strip, and H is between 0.1 and 3cm (figure 2);
3) irradiating the above sheet material with holes with Co60 or sterilizing with ethylene oxide.
The method, before sterilization, further comprises the following operations: soaking the porous sheet material in one or more than two of purified water, physiological saline, physiological buffer solution, chitosan solution, chondroitin sulfate solution and sodium hyaluronate solution, then placing 2-4 layers of wet sheet materials in a staggered and overlapped mode to ensure that no through hole is formed between the layers of materials (figure 3B), tightly attaching the layers by using a clamp, or firmly attaching the layers together by using an adhesive or a suture line to prepare a rectangular, square, trapezoidal, circular or special-shaped biological patch material, and then carrying out freeze drying.
Wherein the concentration of the chitosan solution, the chondroitin sulfate solution and the sodium hyaluronate solution is 0.01-8%.
The conditions for freeze-drying were: pre-freezing at-80 to-40 ℃ for 2 to 12 hours, and then carrying out vacuum low-temperature drying, wherein the temperature is increased from the pre-freezing temperature to more than 4 ℃ in the vacuum low-temperature drying process; the time of vacuum low-temperature drying is about 8 hours preferably; the prefreezing time is preferably about 4 hours.
The natural extracellular matrix used by the invention is derived from tissue materials of allogeneic or xenogeneic organisms which are decellularized, and comprises a bovine dermal matrix, a bovine pericardial matrix, a bovine peritoneal matrix, a porcine bladder submucosa matrix, a porcine small intestine submucosa matrix, a human dermal matrix and the like.
The specific operation of the antigen removal treatment in the step 1) is that according to the method described in experimental research on the influence of the cell removal treatment on the cell residue and the content of the growth factor of the small intestine submucosa in Chenwei, Li Shi Hui, Wushu, Huaixuan, Luo Jing Smart, (2010) journal of Chinese repair and reconstruction surgery, v.24(01):94-99, fresh natural extracellular matrix is taken and is sequentially subjected to disinfection, mechanical stripping (accessory tissues such as fat muscle and the like), degreasing, cell removal and scale removal treatment.
The invention also provides a pelvic floor biological patch prepared according to the method.
The pelvic floor biological patch provided by the invention has certain biomechanical characteristics, good biocompatibility and degradability, maintains the three-dimensional structure of natural extracellular matrix, and is perforated, so that the regeneration induction of the material on peripheral tissues is ensured after the material is implanted into a body, sufficient mechanical support is provided in the treatment process, the implantation amount of the material is reduced as much as possible, the immune risk is reduced, the perforation and surface treatment are expected to maintain the folded structure of the original vaginal inner wall, the pelvic floor biological patch can be applied to the treatment of POP, and the tissue induced and regenerated is more similar to the folded structure of the original tissue.
The invention has the following advantages:
the natural extracellular matrix material is subjected to a series of antigen removal and cell removal treatment, so that the biological safety is ensured.
And (II) the mechanical property of the implant material is improved through a multilayer composite technology, and the softness of the implant material is improved through punching of the material, so that the tissue compliance of the patch is better.
And thirdly, a biological patch which meets the clinical requirements on mechanical properties is obtained by punching or a technology of staggered compounding after punching, the actual material implantation amount is reduced (by more than 12 percent), and the immune risk is reduced.
Drawings
FIG. 1 is a schematic view of the perforation of the pelvic floor biological patch material of the present invention.
FIG. 2 is a schematic view of the perforation of the pelvic floor biological patch material of the present invention (with cross-shaped strips).
Fig. 3 is a schematic diagram of perforating holes (a) and staggered perforations (B) in the pelvic floor biological patch material of the present invention.
Fig. 4 is a photograph showing the repair of vaginal mucosa after implanting the pelvic floor biological patch prepared in example 1 of the present invention into the vagina of beagle dog.
Detailed Description
The following examples are intended to illustrate the invention but are not intended to limit the scope of the invention. Unless otherwise specified, the technical means used in the examples are conventional means well known to those skilled in the art, and the raw materials used are commercially available products.
The percent in the present invention means mass percent unless otherwise specified; but the percent of the solution, unless otherwise specified, refers to the grams of solute contained in 100mL of the solution.
The conditions for freeze-drying in the following examples were: pre-freezing at-80 deg.c to-40 deg.c for 4 hr, and vacuum low temperature drying at the temperature raised from the pre-freezing temperature to over 4 deg.c; the time for vacuum low-temperature drying is about 8 hours.
Example 1 pelvic floor BioPatch and preparation thereof
Preparing the porcine small intestine submucosa acellular matrix material, and performing cross compaction, drying and compounding on 4 layers of the porcine small intestine submucosa acellular matrix material to prepare a sheet material with the thickness of 10cm multiplied by 10 cm.
Punching a through hole with the diameter of 0.4cm on the sheet material (S ≈ 0.125 cm)2) Guarantee every 1cm22 round holes with the diameter of 0.4cm are evenly punched on the upper part of the frame. The perforated area accounts for 25% of the total area. A cross-shaped strip which has the width of 1cm and penetrates through the whole patch is reserved at the central point of the sheet-shaped material, and holes are not punched on the cross-shaped strip.
Wetting the two perforated materials with physiological saline, and staggering the perforated parts for a certain distance to ensure that the two layers of materials do not form through holes. The material was compacted with a clamp and lyophilized, sterilized by Co60 radiation, and packaged for storage.
Through detection, the tensile strength of the punched hole of the material is 40N/cm, the material is attached to the upper layer of the damaged vaginal mucosa of the beagle dog, adverse conditions such as infection and the like do not occur, and the vaginal mucosa regenerates after 4 weeks and forms certain folds. The photograph of the vaginal mucosa repair of beagle dogs is shown in figure 4.
Example 2 pelvic floor BioPatch and preparation thereof
Preparing a porcine small intestine submucosa acellular matrix material, and performing cross compaction, drying and compounding on 2 layers of the porcine small intestine submucosa acellular matrix material to prepare a sheet material with the diameter of 12 cm.
Making a parallelogram hole on the sheet material, wherein the length of the bottom side of the hole is 0.5cm, and the height is 0.1cm (S is approximately equal to 0.05 cm)2) Guarantee per cm2Evenly punching 10 holes on the surface. The perforated area accounts for 50% of the total area.
Wetting two sheets of the punched materials by using 0.1% sodium hyaluronate solution, and staggering the punched positions for a certain distance to ensure that two layers of the materials do not form through holes. The material was compacted with a clamp and lyophilized, sterilized by Co60 radiation, and packaged for storage. Through detection, the tensile strength of the punched hole of the material is 20N/cm, the material is attached to the upper layer of the damaged vaginal mucosa of the beagle dog, adverse conditions such as infection and the like do not occur, and the vaginal mucosa regenerates after 4 weeks and forms certain folds.
Example 3 pelvic floor BioPatch and preparation thereof
Preparing a porcine small intestine submucosa acellular matrix material, and performing cross compaction, drying and compounding on 10 layers of the porcine small intestine submucosa acellular matrix material to prepare a trapezoidal sheet material with an upper bottom of 9cm, a lower bottom of 13cm and a height of 12 cm.
The bottom edge of a hole for forming a parallelogram on the sheet material is 2cm, and the height is 0.5cm (S is approximately equal to 1 cm)2) Guarantee per cm20.8 holes are evenly punched on the upper surface of the substrate. The perforated area accounts for 40% of the total area. A cross-shaped strip which has the width of 3cm and penetrates through the whole patch is reserved at the central point of the sheet-shaped material, and holes are not punched on the cross-shaped strip. The samples were sterilized by ethylene oxide and used after dialysis for 21 days.
The tensile strength of the punched part of the material is 23N/cm through detection. The material is attached to the upper layer of damaged vaginal mucosa of beagle dogs, so that adverse conditions such as infection do not occur, and the vaginal mucosa regenerates after 4 weeks and forms certain folds.
The pelvic floor patch is prepared by compounding and punching natural acellular matrix materials which are low in immunogenicity, good in biocompatibility and biodegradable, the materials are gradually degraded after being implanted into a body, the absolute amount of the implant is reduced while the mechanical support in the body is ensured through the compounding and punching technology, the immune risk is reduced, the compliance between the implanted materials and the pelvic floor soft tissue is improved, the regeneration and repair of the pelvic floor tissue is finally promoted, and the fascia of the soft tissue is reinforced to achieve the purpose of treating the POP.
Although the invention has been described in detail hereinabove with respect to a general description and specific embodiments thereof, it will be apparent to those skilled in the art that modifications or improvements may be made thereto based on the invention. Accordingly, such modifications and improvements are intended to be within the scope of the invention as claimed.
Claims (8)
1. The preparation method of the pelvic floor biological patch is characterized by comprising the following steps:
1) taking natural extracellular matrix subjected to antigen removal treatment as a material, placing 2-4 layers of single materials with the same specification in a staggered or parallel overlapping mode, using a clamp to enable the layers to be tightly attached, or firmly attaching the layers together by using an adhesive or a suture line to manufacture a rectangular, square, trapezoidal, circular or irregularly-shaped preformed sheet material;
2) punching a circular or parallelogram through hole on the preformed sheet material,the area of each hole was 0.05cm2-1cm2The distribution density of the holes is 0.8-10/cm2The area of the perforated part accounts for more than 12 percent of the total area of the preformed sheet material;
3) irradiating the above sheet material with holes with Co60 or sterilizing with ethylene oxide;
before sterilization, the following operations are also included: soaking the porous sheet material in one or more than two mixed solutions of purified water, physiological saline, physiological buffer solution, chitosan solution, chondroitin sulfate solution and sodium hyaluronate solution, then placing 2-4 layers of wet sheet materials in a staggered and overlapped mode to ensure that no through hole is formed between the layers of materials, tightly attaching the layers by using a clamp, or firmly attaching the layers together by using an adhesive or a suture line to prepare a rectangular, square, trapezoidal, circular or special-shaped biological patch material, and then freeze-drying.
2. The method according to claim 1, wherein the antigen-removing treatment in step 1) is performed as follows: taking fresh natural extracellular matrix, and sequentially carrying out disinfection, mechanical stripping, degreasing, decellularization and descaling treatment.
3. The method of claim 1, wherein the natural extracellular matrix is derived from tissue material of allogeneic or xenogeneic organisms, including bovine dermal matrix, bovine pericardial matrix, bovine peritoneal matrix, porcine bladder submucosa matrix, porcine small intestine submucosa matrix, human dermal matrix.
4. The method according to claim 1, characterized in that 4 layers of single materials with the same specification are placed in step 1) in a staggered or parallel superposition.
5. The method of claim 1, wherein the concentration of the chitosan solution, the chondroitin sulfate solution, and the sodium hyaluronate solution is 0.01% to 8%.
6. The method according to any one of claims 1 to 5, wherein the conditions of freeze-drying are: pre-freezing at-80 ℃ to-40 ℃ for 2-12 hours, then carrying out vacuum low-temperature drying, wherein the temperature is increased from the pre-freezing temperature to more than 4 ℃ in the vacuum low-temperature drying process; the time of vacuum low-temperature drying is 8 hours.
7. The method of claim 6, wherein the prefreezing time is 4 hours.
8. A pelvic floor biological patch prepared according to the method of any one of claims 1-7.
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| CN107320774B (en) * | 2017-06-16 | 2020-04-07 | 卓阮医疗科技（苏州）有限公司 | Spliced biological material and preparation method thereof |
| CN107441557B (en) * | 2017-07-05 | 2020-07-17 | 北京大清生物技术股份有限公司 | Functional tissue engineering scaffold material and preparation method thereof |
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| CN108114320A (en) * | 2018-03-01 | 2018-06-05 | 北京迈迪顶峰医疗科技有限公司 | Tissue repair sticking patch, main body and preparation method |
| CN108126241A (en) * | 2018-03-01 | 2018-06-08 | 北京迈迪顶峰医疗科技有限公司 | Tissue repair sticking patch, main body and preparation method |
| CN108524059A (en) * | 2018-05-03 | 2018-09-14 | 上海市第妇婴保健院 | The sling operation method and device of ligamentum inguinale treats pelvic organ prolapse in front of ligamentum teres to anterior superior spine |
| CN109364299B (en) * | 2018-11-28 | 2021-06-01 | 上海白衣缘生物工程有限公司 | Biological pelvic floor repairing mesh and preparation method thereof |
| CN112717205B (en) * | 2021-01-22 | 2022-10-25 | 西岭(镇江)医疗科技有限公司 | Oral repair film prepared from animal-derived biomembrane and preparation method thereof |
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