CN116271243A - Acellular matrix composite rotator cuff patch - Google Patents

Acellular matrix composite rotator cuff patch Download PDF

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Publication number
CN116271243A
CN116271243A CN202310228595.5A CN202310228595A CN116271243A CN 116271243 A CN116271243 A CN 116271243A CN 202310228595 A CN202310228595 A CN 202310228595A CN 116271243 A CN116271243 A CN 116271243A
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acellular
rotator cuff
layer
dermis
matrix composite
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Inventor
陈莉珊
严洁
冉永峰
江涛
李志宏
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Hangzhou Huamai Medical Technology Co ltd
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Hangzhou Huamai Medical Technology Co ltd
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Priority to CN202310228595.5A priority Critical patent/CN116271243A/en
Publication of CN116271243A publication Critical patent/CN116271243A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36Materials 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
    • A61L27/3604Materials 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
    • A61L27/362Skin, e.g. dermal papillae
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36Materials 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
    • A61L27/3604Materials 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36Materials 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
    • A61L27/3641Materials 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
    • A61L27/3645Connective tissue
    • A61L27/3662Ligaments, tendons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36Materials 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
    • A61L27/3683Materials 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
    • A61L27/3687Materials 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/54Biologically active materials, e.g. therapeutic substances
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/412Tissue-regenerating or healing or proliferative agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2430/00Materials or treatment for tissue regeneration
    • A61L2430/10Materials or treatment for tissue regeneration for reconstruction of tendons or ligaments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2430/00Materials or treatment for tissue regeneration
    • A61L2430/40Preparation and treatment of biological tissue for implantation, e.g. decellularisation, cross-linking

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Abstract

The application provides a acellular matrix composite rotator cuff patch which comprises an acellular dermis layer and an acellular pericardium layer, wherein the acellular dermis layer is an upper layer, and the acellular pericardium layer is a lower layer. The acellular matrix composite rotator cuff patch provided by the application is simple in preparation method, has good mechanical property, biocompatibility and tendon bone healing promoting performance, can reduce the post-operation re-tearing rate, promote tendon bone healing, improve the success rate of rotator cuff injury repair operation, and has a good application prospect.

Description

Acellular matrix composite rotator cuff patch
Technical Field
The application relates to the technical field of biological materials, in particular to an acellular matrix composite rotator cuff patch.
Background
Rotator cuff tear is one of the common tendon injuries in orthopedics/sports medicine, and is a common cause of shoulder joint pain, mobility reduction and function weakening. The incidence of rotator cuff tear in the general population was 20.7% and the tear rate increased with age. The tearing rate of the torn rotator cuff after the rotator cuff is repaired is 20% -30%, the probability of the torn rotator cuff is 40% -50%, the total repair failure rate is 94%, and the rotator cuff is the difficulty and the key point in the clinic at present.
Patches are considered ideal choices for performing tensionless or micro-tension suturing. Foreign allogeneic/xenogeneic rotator cuff patches are mainly derived from dermis, pericardium or Small Intestine Submucosa (SIS), and through a series of treatments, only extracellular matrix components such as collagen and elastic fibers are reserved, and simultaneously, cells and active protein components causing tissue rejection reaction are thoroughly removed. However, no rotator cuff patch product is commercially available in China, and the rotator cuff patch is blank, so that rotator cuff patch which can promote healing of tendon bones and reduce the post-operation re-tearing rate is urgently needed, the post-operation recovery effect of a patient after rotator cuff repair is improved, and a new way for treating rotator cuff tearing by doctors is developed.
Disclosure of Invention
The purpose of the application is to provide a cell-free matrix composite rotator cuff patch so as to reduce the postoperative re-tearing rate, promote the healing of tendon bones and improve the success rate of rotator cuff injury repair operation. The specific technical scheme is as follows:
the application provides a acellular matrix composite rotator cuff patch which comprises an acellular dermis layer and an acellular pericardium layer, wherein the acellular dermis layer is an upper layer, and the acellular pericardium layer is a lower layer.
The acellular matrix composite rotator cuff patch provided by the application is simple in preparation method, has good mechanical property, biocompatibility and tendon bone healing promoting performance, can reduce the post-operation re-tearing rate, promote tendon bone healing, improve the success rate of rotator cuff injury repair operation, and has a good application prospect.
Drawings
In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the following description will briefly introduce the drawings that are required to be used in the embodiments or the description of the prior art, and it is obvious that the drawings in the following description are only some embodiments of the present application, and other embodiments may also be obtained according to these drawings to those skilled in the art.
FIG. 1 shows the tensile strength results of the rotator cuff patches made in example 1, comparative examples 1-3;
FIG. 2 shows suture strength results of the rotator cuff patches prepared in example 1 and comparative examples 1-3;
FIG. 3 shows cytotoxicity test results of the rotator cuff patches prepared in example 1 and comparative examples 1 to 3;
FIG. 4 shows the pathological results of chronic giant rotator cuff tear repair in rabbits using rotator cuff patches prepared in example 1, comparative examples 1-3.
Detailed Description
The following description of the embodiments of the present application will be made clearly and fully with reference to the accompanying drawings, in which it is evident that the embodiments described are only some, but not all, of the embodiments of the present application. Based on the embodiments herein, a person of ordinary skill in the art would be able to obtain all other embodiments based on the disclosure herein, which are within the scope of the disclosure herein.
The application provides a acellular matrix composite rotator cuff patch which comprises an acellular dermis layer and an acellular pericardium layer, wherein the acellular dermis layer is an upper layer, and the acellular pericardium layer is a lower layer.
According to the acellular matrix composite rotator cuff patch, the acellular dermis layer and the acellular pericardium layer are combined to form a double-layer structure, the acellular dermis layer is used as a mechanical supporting material, and the acellular pericardium layer is used as a material for promoting healing of tendinous bone, so that healing of tendinous bone can be promoted while the postoperative re-tearing rate is reduced; the acellular matrix composite rotator cuff patch is implanted into a receptor site in a bracket form, and the components such as a three-dimensional structure, collagen, non-collagen, growth factors and the like contained in the acellular matrix composite rotator cuff patch provide a proper environment for adhesion, proliferation and differentiation of host cells, so that regeneration of collagen fibers and blood vessels is promoted, functional reconstruction of tissues such as bones, cartilages and tendons is facilitated, and healing of tendinous bones after rotator cuff repair operation is promoted.
In some embodiments of the present application, the decellularized dermis layer has a thickness of 1-2.5mm.
In some embodiments of the present application, the decellularized dermis layer consists of 1-2 layers of decellularized dermis prepared by:
crosslinking: soaking dermis tissue in a cross-linking solution which has the pH value of 5-6 and contains 10-50 mM (mmol/L) of 1-ethyl- (3-dimethylaminopropyl) carbodiimide hydrochloride (EDC), 10-50 mM of N-hydroxysuccinimide (NHS) and 10-100 mM of 2- (N-morpholinyl) ethanesulfonic acid (MES), oscillating for 3-24 hours at room temperature, and then cleaning with purified water to obtain a cross-linking intermediate;
decellularization: soaking the crosslinked intermediate in acellular solution containing 0.5-1M (mol/L) NaOH, oscillating for 4-24 hours at room temperature, washing with Phosphate Buffered Saline (PBS), and then washing with purified water to obtain acellular dermis;
wherein the dermal tissue is selected from the back dermis of a human, pig, cow or foetus cow.
In the application, the solvent of the crosslinking liquid is water; the decellularized liquid containing 0.5-1M NaOH is an aqueous solution containing 0.5-1M NaOH.
In the application, the crosslinking treatment can enhance the mechanical property of the acellular dermis and can reduce the post-operation re-tearing rate; the surface antigen of the acellular dermis can be sealed, so that the immune response after implantation in the body is lightened, and the biocompatibility of the material is improved.
In some embodiments of the present application, the thickness of the decellularized pericardium layer is 0.2-1mm.
In some embodiments of the present application, the decellularized pericardium layer consists of 2-5 layers of decellularized pericardium having a thickness of 0.1-0.5mm.
In the application, the number of layers of the acellular pericardium is increased, so that the matrix content of the acellular pericardium is increased, and cell proliferation and tendon bone healing can be promoted.
In this application, the surface of decellularized pericardium divide into compact face and loose face, correspond fibrous layer and serosa wall layer respectively, and wherein, loose face is porous structure, is favorable to cell infiltration and quick vascularization to can improve the healing performance of tendinous bone.
In the application, the acellular pericardium layer can be formed by superposing the acellular pericardium layer in a physical combination mode such as stitching or negative pressure, and the loose surface of the pericardium layer is controlled to face outwards (namely, the pericardium layer can be clung to an affected part when in use) when the acellular pericardium layer is superposed.
In some embodiments of the present application, the decellularized pericardium is prepared by the following method:
decellularization: taking a core envelope tissue, soaking the core envelope tissue in a decellularized liquid containing 0.1-1M NaOH, oscillating for 10-120 minutes at room temperature, washing with PBS, and washing with purified water to obtain the decellularized core envelope;
wherein the pericardial tissue is selected from human, pig, cow or fetal cow.
In the present application, the decellularized solution containing 0.1 to 1M NaOH is an aqueous solution containing 0.1 to 1M NaOH.
The acellular matrix composite rotator cuff patch provided by the application takes acellular dermis after crosslinking and acellular treatment as an upper layer and takes acellular pericardium after acellular treatment as a lower layer as a mechanical support to promote healing of tendinous bones.
In this application, the PBS is a PBS buffer commonly used in the art, which can be formulated according to existing formulations by those skilled in the art, and which typically includes Na 2 HPO 4 、KH 2 PO 4 NaCl and KCl; illustratively, the formulation of the PBS buffer includes: weighing NaCl, KCl, na 2 HPO 4 、KH 2 PO 4 Dissolving in water, adjusting pH to 7.3-7.5 with HCl, adding water, and fixing volume to obtain PBS buffer solution, wherein NaCl is mass, KCl mass, na 2 HPO 4 Quality, KH 2 PO 4 The ratio of the mass to the water volume is 7-9g:0.1-0.3g:1.4-1.5g:0.2-0.3g:1L.
Hereinafter, embodiments of the present application will be described more specifically with reference to examples and comparative examples, but the present application is not limited to the examples described below. The experimental materials and methods used in the examples below are conventional materials and methods unless otherwise specified. PBS preparation: 8.0g NaCl, 0.2g KCl and 1.44g Na are weighed 2 HPO 4 、0.24g KH 2 PO 4 Dissolving in 800mL of distilled water, adjusting the solution to pH=7.4 with HCl, and finally adding distilled water to a volume of 1L to obtain PBS buffer.
The testing method comprises the following steps:
tensile strength test:
determination of tensile Properties of plastics according to GB/T1040.2-2022 part 2: test conditions for molded and extruded plastics the test was carried out using a 5A dumbbell specimen with a tensile speed of 10 mm/min.
Suture strength test:
the test was performed according to the suture strength of 5.1.5 in YY/T1814-2022 surgical implant synthetic non-absorbable patch hernia repair patch.
Cytotoxicity test:
part 5 of the biological evaluation of medical instruments according to GB/T16886.5-2017: in vitro cytotoxicity assays and GB/T16886.12-2017 medical device biological evaluation part 12: sample preparation and reference materials, testing was performed using the leach solution method and L929 cells.
Animal experiment:
the normal supraspinatus tendon of New Zealand rabbits is manually cut off for 6 weeks to obtain a chronic giant rotator cuff tear model. The double-row suturing method and the patch are used for repairing the giant rotator cuff tear, the rotator cuff tear repairing condition is observed in 16 weeks, wherein hematoxylin-eosin (HE) staining and Masson trichromatic (Masson) staining are respectively carried out on the boundary of the tendon and bone, HE staining is carried out on the supraspinatus muscle, and the image is observed under a microscope.
Example 1
< preparation of acellular dermis >
Crosslinking: soaking pig back dermis tissue in a crosslinking solution containing 30mM EDC, 30mM NHS, 50mM MES and pH of 5.5, oscillating at room temperature for 16 hours, and cleaning with purified water to obtain a crosslinking intermediate;
decellularization: soaking the crosslinked intermediate in decellularized liquid containing 1M NaOH, oscillating for 4 hours at room temperature, washing with PBS to neutrality, and washing with purified water to obtain decellularized dermis with thickness of 1.2mm;
< preparation of acellular pericardium >
Decellularization: soaking porcine pericardium tissue in decellularized liquid containing 0.1M NaOH, oscillating for 1 hour at room temperature, washing with PBS, and washing with purified water to obtain decellularized pericardium with thickness of 0.3mm;
< preparation of acellular matrix composite rotator cuff Patch >
And stitching the 1 layer of acellular dermis and the 2 layers of acellular pericardium to obtain the acellular matrix composite rotator cuff patch.
Comparative example 1
< preparation of acellular dermis >
Decellularization: soaking pig back dermis tissue in decellularized liquid containing 1M NaOH, oscillating at room temperature for 4 hours, washing with PBS to neutrality, and washing with purified water to obtain decellularized dermis with thickness of 1.2mm;
< preparation of acellular pericardium >
As in example 1;
< preparation of acellular matrix composite rotator cuff Patch >
And suturing the 1 layer of acellular dermis and the 2 layers of acellular pericardium to obtain the rotator cuff patch.
Comparative example 2
The dermis tissue of the back of the pig was taken, decellularized dermis was prepared by the dermis tissue crosslinking and decellularizing method in example 1, and 2 layers of decellularized dermis were sutured to obtain a rotator cuff patch.
Comparative example 3
Taking pig pericardium tissue, preparing a decellularized pericardium by using the pericardium tissue decellularization method in the embodiment 1, and sewing 4 layers of decellularized pericardium to obtain the rotator cuff patch.
The rotator cuff patches prepared in the examples 1 and the comparative examples 1-3 are tested according to the test method, and the tensile strength, the suture strength and the cytotoxicity test results of the rotator cuff patches are shown in the figures 1, 2 and 3 respectively, and the results show that the tensile strength and the suture strength of the rotator cuff patch in the example 1 are equivalent to those of the rotator cuff patch in the comparative example 2 and are obviously higher than those of the rotator cuff patches in the comparative example 1 and the rotator cuff patch in the comparative example 3 (P < 0.05 and P < 0.01), so that the rotator cuff patch has good mechanical properties; the cytotoxicity results of the rotator cuff patches have no significant difference, and the acellular matrix composite rotator cuff patches have good biocompatibility.
Taking the rotator cuff patches prepared in the example 1 and the comparative examples 1-3, and carrying out the animal experiments to obtain the HE dyeing and Masson dyeing results of the interface of the tendinous bones and the HE dyeing result of the supraspinatus muscle, wherein the HE dyeing results are shown in the figure 4, and it can be seen that the tendinous bones of the comparative example 1 and the comparative example 2 are obviously demarcated, have no good integration and regeneration, and the supraspinatus muscle has a fat trend; the tendon-bone interface of comparative example 3 is rich in vascularization and good in regeneration, but the supraspinatus muscle is severely lipidated; whereas example 1 had excellent regeneration of the tendinous bone interface and minimal supraspinatus muscle fat. The post-operative re-tearing rate is related to the mechanical property and muscle fat of the patch, so that the tendon-bone interface regeneration performance of the acellular matrix composite rotator cuff patch is optimal, and the possibility of post-operative re-tearing is lowest.
In conclusion, the acellular matrix composite rotator cuff patch provided by the application has good mechanical property and biocompatibility, can effectively regenerate the boundary tissue of the tendinous bone, and reduces the postoperative re-tearing rate.
The foregoing description is only of the preferred embodiments of the present application and is not intended to limit the scope of the present application. Any modifications, equivalent substitutions, improvements, etc. that are within the spirit and principles of the present application are intended to be included within the scope of the present application.

Claims (6)

1. The acellular matrix composite rotator cuff patch comprises an acellular dermis layer and an acellular pericardium layer, wherein the acellular dermis layer is an upper layer, and the acellular pericardium layer is a lower layer.
2. The acellular matrix composite rotator cuff patch of claim 1, wherein the thickness of the acellular dermis layer is 1-2.5mm.
3. The acellular matrix composite rotator cuff patch of claim 2, wherein the acellular dermis layer consists of 1-2 layers of acellular dermis prepared by:
crosslinking: soaking dermis tissue in cross-linking liquid containing pH 5-6, 10-50 mM 1-ethyl- (3-dimethylaminopropyl) carbodiimide hydrochloride, 10-50 mM N-hydroxysuccinimide and 10-100 mM 2- (N-morpholin) ethanesulfonic acid, oscillating at room temperature for 3-24 hours, and then cleaning with purified water to obtain a cross-linking intermediate;
decellularization: soaking the crosslinked intermediate in acellular liquid containing 0.5-1M NaOH, oscillating for 4-24 hours at room temperature, washing with PBS, and washing with purified water to obtain acellular dermis;
wherein the dermal tissue is selected from the back dermis of a human, pig, cow or foetus cow.
4. The acellular matrix composite rotator cuff patch of claim 1, wherein the thickness of the acellular pericardium layer is 0.2-1mm.
5. The acellular matrix composite rotator cuff patch of claim 4, wherein the acellular pericardium layer consists of 2-5 layers of acellular pericardium having a thickness of 0.1-0.5mm.
6. The acellular matrix composite rotator cuff patch of claim 5, wherein the acellular pericardium is prepared by the method of:
decellularization: taking a core envelope tissue, soaking the core envelope tissue in a decellularized liquid containing 0.1-1M NaOH, oscillating for 10-120 minutes at room temperature, washing with PBS, and washing with purified water to obtain the decellularized core envelope;
wherein the pericardial tissue is selected from human, pig, cow or fetal cow.
CN202310228595.5A 2023-03-10 2023-03-10 Acellular matrix composite rotator cuff patch Pending CN116271243A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN118370873A (en) * 2024-06-20 2024-07-23 卓阮医疗科技(苏州)有限公司 Biological film for repairing abdominal and pelvic wound surface and preparation method thereof

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN118370873A (en) * 2024-06-20 2024-07-23 卓阮医疗科技(苏州)有限公司 Biological film for repairing abdominal and pelvic wound surface and preparation method thereof
CN118370873B (en) * 2024-06-20 2024-09-17 卓阮医疗科技(苏州)有限公司 Biological film for repairing abdominal and pelvic wound surface and preparation method thereof

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