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Biological repair tablet for herniae and preparation method thereof

A patch and biological technology, applied in medical science, prosthesis, etc., can solve the problems of affecting the product's anti-infective ability, tissue regeneration ability, destroying the three-dimensional structure, product instability, etc., to increase the DNA removal link and optimize the preparation process. , stability and low immunogenicity

Active Publication Date: 2015-04-15
BEIJING BIOSIS HEALING BIOLOGICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

On the other hand, Biodesign Surgisis products use common hybrid pigs as animal sources, and individual differences in the genetic background of hybrid animals lead to instability and inconsistency in different batches of products
On the other hand, the vacuum compression and freeze-drying molding process adopted by Biodesign Surgisis products compresses the spatial structure of SIS materials, destroys the natural three-dimensional structure of ECM, and affects the anti-infection ability of the product and the ability to promote tissue regeneration

Method used

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  • Biological repair tablet for herniae and preparation method thereof
  • Biological repair tablet for herniae and preparation method thereof
  • Biological repair tablet for herniae and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] Embodiment 1: Preparation of 8-layer hernia biological repair sheet

[0047] The preparation method is as follows:

[0048] (1) Determination of animal source and pretreatment and initial washing of small intestine tissue

[0049] The Chinese inbred Wuzhishan minipig was selected as the animal source, and the animal species was determined using the method specified in the patent ZL200510008994.2. The small intestine tissue of the freshly slaughtered Chinese inbred Wuzhishan minipig was cleaned, and the small intestinal submucosa was separated and used Rinse with water for injection 3 times.

[0050] (2) Virus inactivation

[0051] Adopt the peracetic acid-ethanol solution method to inactivate the virus, this step is carried out in the constant temperature ultrasonic cleaner that the cleaning tank can vibrate, wherein the volume percentage of peracetic acid is 0.05~0.2% (preferably 0.1%), inactivation The time is 1 to 2 hours (preferably 1 hour), the temperature range...

Embodiment 2

[0060] Embodiment 2: Physical and chemical properties, histology, growth factor and biological performance detection of the material prepared in embodiment 1

[0061] 1. The physical properties of the prepared 8-layer material are tested, and the testing items include porosity measurement, suture retention, tensile strength, and burst strength.

[0062] 1) Porosity measurement: Mercury porosimetry was used to measure the porosity of the material, and compared with and compared with Biodesign Surgisis products. Results: The porosity of the sample provided in Example 1 was 87.8±2.51, and the porosity of the Biodesign Surgisis product was 78.3±6.38.

[0063] 2) Suture retention test: method: use 2-0 surgical sutures or stainless steel wires of the same diameter to suture at 2 mm inside the edge of one end of the patch, and fix the suture or stainless steel wire and the other end of the patch on a tension meter On, stretch at a speed of 20mm / min until the suture point is torn, an...

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Abstract

The invention provides a biological repair tablet for herniae and a preparation method thereof. The repair tablet uses small intestine submucosa tissues of inbred line animals without cell and DNA (deoxyribonucleic acid) components as the raw material, completely reserves the extracellular matrix component and structure, and has a micropore structure. The preparation method of the repair tablet comprises the following operation steps: determination of animal source, pretreatment and rough cleaning of small intestine tissues, virus inactivation, cell removal, DNA removal treatment, formation, packaging and sterilization. The biological repair tablet for herniae prepared by the method uses an inbred line animal as an animal source, and thus, the hereditary features are pure, stable and uniform, thereby radically ensuring the stability and uniformity of different batches of products; and the biological repair tablet for herniae has fewer animal source DNA residues, completely reserves the three-dimensional structure of natural ECM, and has the advantages of low immune source property and high infection resistance.

Description

technical field [0001] The invention relates to the technical field of animal-derived implantable medical devices, in particular to a hernia biological repair sheet and a preparation method thereof. Background technique [0002] The organ or tissue in the abdominal cavity protrudes from the weak area or defect of the abdominal wall, which is called abdominal wall hernia in medicine, and is a frequently-occurring and common disease in surgery. Weakness and defect of abdominal wall tissue caused by various congenital and acquired causes are the cause of hernia. Surgery is currently the only effective treatment. Tension-free hernia repair is currently the main surgical method for hernia. With the rapid development of medical biomaterials, various hernia repair materials have been widely used in clinical practice. [0003] According to the chemical composition and biological characteristics of materials, hernia repair materials mainly include non-absorbable materials, absorba...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61L27/36A61L27/56
Inventor 赵博王振军
Owner BEIJING BIOSIS HEALING BIOLOGICAL TECH
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