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Pelvic floor biologic repairing mesh and preparation method thereof

A biological and pelvic floor technology, applied in tissue regeneration, medical science, prosthesis, etc., can solve the problems of increasing the mechanical strength of biomaterials, cytotoxicity, and slow degradation rate, so as to reduce the incidence of inflammation and infection and accelerate the function The effect of permanent reconstruction and good mechanical properties

Active Publication Date: 2019-02-22
上海白衣缘生物工程有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] In practical applications, the acellular material patch needs to introduce chemical cross-linking agents such as epoxy or glutaraldehyde during its processing due to its insufficient mechanical strength, which has the following disadvantages: potential cytotoxicity and slow degradation rate , does not match tissue regeneration, which can lead to fibrosis, chronic inflammation, etc.
The Chinese invention patent with the authorization number CN103800942, the pelvic floor patch, is made of non-degradable and degradable synthetic materials into patches by electrospinning and other technologies; the Chinese invention patent with the application number 201610678065.0, although it is made of biological materials A patch, but only clamps the layers together tightly, or uses adhesives or sutures to hold the layers firmly together, without substantially increasing the mechanical strength of the biomaterial

Method used

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  • Pelvic floor biologic repairing mesh and preparation method thereof
  • Pelvic floor biologic repairing mesh and preparation method thereof
  • Pelvic floor biologic repairing mesh and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] Preparation of porcine small intestinal submucosa pelvic floor bioprosthetic mesh, see Figure 5 :

[0056] (1) Pretreatment

[0057] Freshly slaughtered porcine small intestine tissue was cleaned and soaked in 0.5% acetic acid solution for 30 minutes. The ratio of porcine small intestine to acetic acid solution was 1:5, and the mucosal layer, muscular layer and serosa layer of porcine small intestine and jejunum were removed by physical scraping , lymph nodes, the submucosa was separated, cut into thin strips evenly in the longitudinal direction, and washed 3 times with purified water to obtain a biological repair material, that is, small intestinal submucosa, hereinafter referred to as SIS material.

[0058] (2) Virus inactivation

[0059] Use a mixed aqueous solution containing 1.0% peracetic acid and 15% ethanol, the ratio of the SIS material to the mixed aqueous solution is 1:10, and soak at room temperature for 100 minutes under ultrasonic conditions to inactiva...

Embodiment 2

[0070] Preparation of bioprosthetic mesh for pelvic floor of porcine small intestine submucosa

[0071] (1) Pretreatment

[0072] Freshly slaughtered porcine small intestine tissue was cleaned and soaked in 0.01% acetic acid solution for 120 minutes. The ratio of porcine small intestine to acetic acid solution was 1:10, and the mucosal layer, muscular layer and serosa layer of porcine small intestine and jejunum were removed by physical scraping , Lymph nodes, the submucosa was separated, cut into pieces, and washed 3 times with purified water.

[0073] (2) Virus inactivation

[0074] Use a mixed aqueous solution containing 0.5% peracetic acid and 25% ethanol, the ratio of the SIS material to the mixed aqueous solution is 1:15, and soak at room temperature for 120 minutes under ultrasonic conditions to inactivate the virus. Afterwards, it was ultrasonically washed 3 times with purified water.

[0075] (3) Degreasing

[0076] Use ethanol with a concentration of 90%, the rat...

Embodiment 3

[0085] For the safety of the samples, the samples prepared in Example 1-2 were tested for immunogenic substances.

[0086] (1) Detection method of residual cells: fixed with 10% neutral formalin, embedded in paraffin, cut into thin slices of 0.4 micron, dewaxed with xylene, dehydrated with serial alcohol, stained with hematoxylin-eosin, and microscope Next, observe the cell residue and matrix fiber structure.

[0087] (2) DNA content detection method: according to YY / T 0606.25-2014 "Determination of DNA residues in biological materials of animal origin: fluorescent staining method".

[0088] (3) α-Gal antigen content detection method: After the sample was fixed with paraformaldehyde, it was routinely embedded in paraffin and sectioned, with a thickness of 3 microns. Immunohistochemical reaction was carried out by using the specific affinity between biotin-labeled BSI-B4 and α-Gal antigen. Judgment of staining results: dark brown granules are strong positive (+++), brown gran...

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Abstract

The invention discloses a pelvic floor biologic repairing mesh and a preparation method thereof. The pelvic floor biologic repairing mesh takes animal tissue as raw materials, immune components such as cells and DNA are removed, the animal tissue are cut into fine strips, and then the fine strips are twisted into threads and weaved into a patch. Acellular materials obtain the higher strength by being twisted into the threads, and thus are not prone to breaking; after weaving, interweaving exists between the threads are interwoven, external force for stretching and tearing acts on multiple interweaving points instead of one point, thus the good mechanical properties are achieved, and the defects that a pelvic floor biologic patch made of the acellular materials is poor in mechanical strength, and a cross-linking agent or a synthetic material is needsed to be introduced are overcome; a structure of the mesh is prepared from by / through a weaving technology, and the size of the hole diameter of the mesh can be easily adjusted through weaving parameters in order to meet the needs of practical application; and meanwhile, an original three-dimensional structure and components such as non-collagen proteins and growth factor in an extracellular matrix are reserved in the pelvic floor biologic patch, and thus functional reconstruction of the tissues and postoperative healing are promoted.

Description

technical field [0001] The invention relates to the field of biological materials, in particular to a pelvic floor biological repair mesh and a preparation method thereof. Background technique [0002] Female pelvic floor dysfunction mainly manifests as pelvic organ prolapse and stress urinary incontinence. It is reported that 50% of multiparous women have pelvic floor dysfunction to varying degrees. Surgery is the main method for the treatment of more serious pelvic floor dysfunction, and the surgical methods are mainly repair and suspension of various tissues and physiological structures. It is often necessary to implant materials such as mesh at the same time to enhance the curative effect of the operation. Tension-free pelvic floor repair is currently the main surgical method for the pelvic floor. With the rapid development of medical biomaterials, various pelvic floor repair materials have been widely used in clinical practice. [0003] Pelvic floor meshes are mainly...

Claims

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Application Information

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IPC IPC(8): A61L27/36A61L27/50A61L27/54A61L27/58
CPCA61L27/3633A61L27/3687A61L27/3691A61L27/50A61L27/54A61L27/58A61L2300/404A61L2300/41A61L2300/412A61L2300/604A61L2430/34
Inventor 韩韦红葛翠兰钱锵周秀清
Owner 上海白衣缘生物工程有限公司