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A hernia patch, its preparation method and its application in hernia repair

A water-for-injection and allogeneic technology, applied in the field of tissue engineering of biomedical materials, can solve the problems of residual antigenic components, inconvenient storage and transportation, low tensile strength, etc., to reduce cytotoxicity and rejection, and achieve good decellularization effect. , the effect of improving mechanical properties

Active Publication Date: 2021-02-26
BEIJING JAYYALIFE BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The former removes cells and antigenic components in skin tissue by chemical detergents combined with other auxiliary reagents, such as removing cells in a solution containing EDTA and trypsin or DispaseII enzyme, and then incubating them in TritonX-100; the latter is prepared by Hypertonic sodium chloride and SDS preparation, but more antigenic components will remain
In addition, there are also preparation methods such as trypsin digestion method, repeated freezing and thawing method, NaOH erosion method, and balanced salt incubation method, but they are less used than the first two methods.
The above preparation method is a general method for preparing acellular allogeneic dermal matrix, and does not consider the special requirements of hernia repair on the tensile strength, elasticity, and elongation of the mesh, especially the effect of intra-abdominal pressure on the tensile strength and elasticity of the hernia repair mesh. When applied to the treatment of hernia repair, there may be the needs of patients with lower tensile strength and less elasticity that cannot meet the needs of abdominal wall expansion
[0007] At present, there are products of acellular allogeneic dermis materials used in hernia repair in the market, but they need to be stored in saline, the validity period is short, and storage and transportation are inconvenient

Method used

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  • A hernia patch, its preparation method and its application in hernia repair
  • A hernia patch, its preparation method and its application in hernia repair
  • A hernia patch, its preparation method and its application in hernia repair

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0062] Example 1 Preparation method of acellular allodermal matrix

[0063] Put allogeneic leather raw materials into 0.2g / L phospholipase and 0.1g / L trypsin solution, the pH value of the enzyme solution is 7.0, the temperature is 37°C, shake at 100rpm for 2 hours, replace the enzyme solution once, repeat this process once, The semi-finished product A is obtained; the phospholipase is a mixture of phospholipase A1, phospholipase A2, phospholipase C and phospholipase D according to the mass ratio of 1:1:1:1.

[0064] The semi-finished product A was taken out, soaked in physiological saline, and oscillated 3 times, each time for 2 hours, with an oscillating speed of 80 rpm and a temperature of 2°C to obtain a semi-finished product B.

[0065] Put semi-finished product B into TritonX-100 solution containing 0.2g / L, 50KHz, 220W, ultrasonic for 5 minutes, soak for 3 hours, repeat this process 3 times to get semi-finished product C.

[0066] The semi-finished product C was taken ou...

Embodiment 2

[0076] Example 2 Preparation method of acellular allogeneic dermal matrix

[0077] Put allogeneic leather raw materials into 0.1g / L phospholipase and 0.1g / L trypsin solution, the pH value of the enzyme solution is 7.0, the temperature is 37°C, shake at 100rpm for 2 hours, replace the enzyme solution once, repeat this process once, The semi-finished product A is obtained; the phospholipase is a mixture of phospholipase A1, phospholipase A2, phospholipase C and phospholipase D according to the mass ratio of 1:1:1:1.

[0078] The semi-finished product A was taken out, put into a container filled with physiological saline solution, soaked in physiological saline, oscillated 3 times, each time for 2 hours, the oscillation speed was 80 rpm, and the temperature was 2°C to obtain the semi-finished product B.

[0079] Put the semi-finished product B into the SDS solution containing 0.2g / L, 10mM EDTA, 50KHz, 220W, ultrasonic for 7 minutes, soak for 2 hours, repeat this process 3 times, ...

experiment example 1

[0089] Experimental example 1 Detection of biological properties of acellular allogeneic dermal matrix

[0090] Biological properties such as the mechanical characteristics of the acellular allogeneic dermal matrix (i.e. finished product K, hernia patch) prepared in Example 1-2 and the acellular allogenic dermal matrix (control group) produced by a domestic enterprise are tested, and the performance index Including tensile strength, suture strength, bursting strength, tensile elongation, water content, and DNA residue. The specific test results are shown in Table 1. The results show that the product of the invention has good toughness and elasticity, is convenient for suturing and pulling, and has sufficient tensile strength, which can meet the treatment needs of hernia repair patch.

[0091] Table 1 Test results after rehydration of acellular allogeneic dermal matrix

[0092] Acellular Allodermal Matrix Example 1 product Example 2 product control group T...

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Abstract

The invention relates to a hernia patch, a preparation method and its application in hernia repair. The hernia patch is made from allogeneic skin material after completely removing all cells that can cause immune rejection of the host, and completely retaining the same extracellular matrix as the original tissue structure; the tensile strength of the acellular allogeneic dermal matrix 3.0MPa‑7.0MPa, suture strength 18N‑22N, tensile elongation 10%‑30%, burst strength 20KPa‑30KPa. The hernia patch of the present invention has the effect of inducing tissue generation, and can be recognized as autologous tissue by human tissue cells after being implanted into the human body, and new blood vessels and fibroblasts will grow in quickly, guiding cells to grow orderly along its collagen framework, achieving For purposes of supplementation, especially rapid repair, the patch does not degrade 24 weeks after supplementation.

Description

technical field [0001] The invention belongs to the technical field of tissue engineering of biomedical materials, and in particular relates to a hernia patch, its preparation method and its application in hernia repair. Background technique [0002] A hernia is any organ or tissue that leaves its original location and enters another site through a normal or abnormal congenital or acquired weak point, defect or hole in the body. Hernia can be divided into direct inguinal hernia, indirect inguinal hernia, femoral hernia, umbilical hernia, linea alba hernia and incisional hernia according to its location. General symptoms: prominent when standing, disappear after lying on the back, and can return to the abdominal cavity when pressed. Hernia first affects patient's digestive system, thereby occurs the symptoms such as hypogastric region pendant bulge, flatulence, stomachache, constipation, alimentary absorption function is poor, fatiguability and body constitution decline. An...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61L27/36
CPCA61L27/362A61L27/3687A61L27/3691A61L27/3695A61L2430/40
Inventor 孙继煌石清东
Owner BEIJING JAYYALIFE BIOTECH CO LTD
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