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Soft tissue repair patch and preparation method thereof

A soft tissue and patch technology, applied in tissue regeneration, medical science, prosthesis, etc., can solve the problems of uneven decellularization effect, incomplete cell removal, and cytotoxicity, so as to improve biocompatibility and maintain compliance Effects on Sexuality and Mechanical Properties

Inactive Publication Date: 2020-05-19
HEBEI AINENG BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The acellular dermal matrix prepared in existing patents or literatures has disadvantages such as incomplete cell removal, poor biocompatibility, low tensile strength, or high processing intensity that seriously damages the natural spatial structure of the material.
For example, dispase, deoxyribonuclease and galactosidase are used in Chinese patent 201310376619.8, and keratinase and trypsin are used in patent 201410377104.4 for degreasing and decellularization. The application of various enzymes will make the space structure in the matrix material excessive Loose, which affects the mechanical properties and repair effect of the product
In Chinese patent 201210060671.8, alkali and surfactant are used to degrease animal dermal matrix, and trypsin, ammonium sulfate, SDS, etc. are used for decellularization. The degree of matrix damage is small, but it has been verified that the decellularization effect is not uniform, which increases the risk of immune rejection after the product is implanted in the body
The Chinese patent No. CN1387923 discloses a heterogeneous acellular dermal scaffold and its preparation method. The scaffold is obtained by treating suckling pig skin with trypsin and glutaraldehyde. The dermal scaffold treated by this method has tensile strength High and good biocompatibility, but its permeability is poor, the wound is prone to fluid accumulation, gas accumulation, slow vascularization, and glutaraldehyde is toxic to cells, which is potentially dangerous
In addition, when the above-mentioned acellular tissue patch is applied in the abdominal cavity, one of the key points to pay attention to is the anti-adhesion between the material and the intra-abdominal tissue. Once the material and the intra-abdominal adhesion occur, intestinal obstruction, intestinal fistula, and abdominal pain will occur. Various types of postoperative complications seriously affect the use effect of the product, and this problem has not been effectively solved

Method used

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  • Soft tissue repair patch and preparation method thereof
  • Soft tissue repair patch and preparation method thereof
  • Soft tissue repair patch and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Step 1. Preparing split skin slices: the pretreated porcine skin is removed by using a skin-taking machine to prepare split slices with a thickness ranging from 0.6 to 0.8 mm, and cleaned with purified water.

[0052] Step 2, inactivation: soak the obtained skin slices in 0.1% bromogeramine for 30 minutes for preliminary disinfection treatment.

[0053] Step 3, one-time decellularization: the first decellularization treatment was performed by using a PBS solution with a concentration of 0.125% trypsin (mass volume ratio g / 100ml) and 10mM EDTA. ℃ decellularization treatment for 6h.

[0054] Step 4, cross-linking modification: the material treated in step 3 was cross-linked and modified with an aqueous solution containing 50 mmol / L EDC, 40 mmol / L NHS, and 40 mmol / LMES, and cross-linked at room temperature for 4 hours at 25°C.

[0055] Step 5, decellularization with detergent: use PBS solution mixed with 0.5% TritonX-100 and 0.25% SDS for a second decellularization treatm...

Embodiment 2

[0061] Step 1. Preparing split skin slices: taking the pretreated cow skin by using a skinning machine, and preparing split skin slices with a thickness ranging from 0.5 to 0.7 mm. Wash well with phosphate buffered saline.

[0062] Step 2, inactivation: soak the obtained skin slices in 75% ethanol solution at room temperature for 2 hours for preliminary disinfection treatment.

[0063] Step 3. Enzymatic decellularization: use 0.1% (mass volume ratio g / 100ml) trypsin and 8mM EDTA in PBS solution for initial decellularization treatment. The treatment conditions are pretreatment at room temperature 25°C for 1 hour, and then transfer to low temperature for 6 ℃ treatment for 10h.

[0064] Step 4. Cross-linking modification: the decellularized material was modified by cross-linking with 40% ethanol solution prepared by 40mmol / L EDC, 20mmol / LNHS, and 20mmol / LMES, cross-linked at room temperature for 6h, and rinsed with PBS.

[0065] Step 5, decellularization with detergent: select ...

Embodiment 3

[0070] Step 1. Preparing split skin slices: the skin of the pretreated sheep is reversed by a skin harvester to prepare split slices with a thickness ranging from 0.8 to 1.0 mm, and cleaned with normal saline.

[0071] Step 2, inactivation: soak the obtained skin slices in 0.5% peracetic acid disinfectant for 20 minutes for preliminary disinfection treatment.

[0072] Step 3. Enzymatic decellularization: Use 0.2% (mass volume ratio g / 100ml) trypsin and 5mM EDTA in PBS solution for initial decellularization treatment. The treatment conditions are pretreatment at room temperature 25°C for 2 hours, and then transfer to low temperature 8°C for decellularization. Cells were treated for 16h.

[0073] Step 4, cross-linking modification: the decellularized material was prepared as a cross-linking solution with an aqueous solution of 30 mmol / l EDC, 20 mmol / l NHS, and 20 mmol / l MES, and cross-linked at room temperature for 5 hours.

[0074] Step 5, decellularization with detergent: use...

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Abstract

The invention relates to a soft tissue repair patch and a preparation method thereof. The patch is prepared by taking mammalian skin tissues as a raw material by the following steps: carrying out pretreatment to remove subcutaneous auxiliary tissues, preparing a skin patch, carrying out primary decellularization, carrying out cross-linking modification, carrying out secondary decellularization, finally carrying out cleaning and cutting, carrying out drying and compounding, and carrying out terminal sterilization. The biological decellularized tissue patch prepared by the method not only has acomplete collagen three-dimensional structure, but also has the characteristics of good mechanical property, abdominal cavity adhesion prevention and the like. The patch product provided by the invention is suitable for repair of various soft tissue injuries and abdominal wall defects in surgical operations, and can also be used as a biological scaffold material in the field of biological engineering.

Description

technical field [0001] The invention belongs to the technical field of tissue engineering, and in particular relates to a soft tissue repair patch and a preparation method thereof. Background technique [0002] Abdominal wall defects caused by trauma, infection and tumor resection are often clinical problems. Functional reconstruction after abdominal wall defect, especially the repair and reconstruction of abdominal wall defect with large defect or high tension, is still one of the clinical problems in surgery. [0003] In the development process of abdominal wall defect treatment, the application of materials for repair has epoch-making significance. Although the current non-degradable materials can significantly reduce the postoperative recurrence rate due to their high mechanical strength, their application is also limited due to potential complications such as seroma, infection, chronic pain, shrinkage of the patch, and possible recurrence and adhesion. . The use of b...

Claims

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Application Information

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IPC IPC(8): A61F2/00A61L27/20A61L27/36A61L27/50
CPCA61F2/0063A61L27/3687A61L27/3691A61L27/20A61L27/50A61L2430/34A61L2430/40C08L5/08
Inventor 李晶杨利霞樊立涛徐兰举杜亚东
Owner HEBEI AINENG BIOTECH CO LTD
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