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Hernia patch, preparation method and application thereof in herniorrhaphy

A water-for-injection, 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 elasticity, etc. Effects of elasticity and toughness

Active Publication Date: 2018-07-10
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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  • Hernia patch, preparation method and application thereof in herniorrhaphy
  • Hernia patch, preparation method and application thereof in herniorrhaphy
  • Hernia patch, preparation method and application thereof in herniorrhaphy

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0062] Example 1 Preparation method of acellular allodermal matrix

[0063] Put the allogeneic leather raw material into the concentration of 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 the semi-finished product B into the TritonX-100 solution containing 0.2g / L, 50KHz, 220W, ultrasonic for 5 minutes, soak for 3 hours, repeat this process 3 times, and get the semi-finished product C.

[0066] Th...

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

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Abstract

The invention relates to a hernia patch, a preparation method and application thereof in herniorrhaphy. The hernia patch is prepared by completely removing all cells possibly causing host immunological rejection from an allogenic skin raw material and integrallty retaining extracellular matrix with the same original tissue structure. The acellular allogenic dermal matrix has tensile strength of 3.0MPa-7.0MPa, stitching strength of 18N-22N, tensile elongation of 10%-30% and bursting strength of 20KPa-30KPa. The hernia patch provided by the invention has the effect of inducing tissue generation,and can be recognized as autologous tissue by human tissue cells after implantation, and soon new blood vessels and fibroblasts can grow into the patch to guide orderly growth of cells along the collagen frame, thus reaching the purpose of supplementation, especially fast repair. The patch is non-degradable within 24 weeks after filling.

Description

Technical field [0001] The invention belongs to the technical field of tissue engineering of biomedical materials, and specifically relates to a hernia patch, its preparation method and its application in hernia repair. Background technique [0002] Hernia refers to any organ or tissue leaving its original position and entering another part through a normal or abnormal weak point, defect or hole formed in the human body, whether congenital or acquired. Hernias are divided into direct inguinal hernias, indirect inguinal hernias, femoral hernias, umbilical hernias, linea alba hernias, and incisional hernias according to their location; they are divided into easily reducible hernias, irreducible hernias, incarcerated hernias, strangulated hernias, etc. General symptoms: protrudes when standing, disappears after lying on your back, and can return to the abdominal cavity when pressed. Hernia first affects the patient's digestive system, causing symptoms such as distension in the...

Claims

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Application Information

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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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