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A kind of pelvic floor biological repair 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, cytotoxicity, slow degradation rate of biomaterials, reduce the incidence of inflammation and infection, and speed up the function The effect of sexual reconstruction and good mechanical properties

Active Publication Date: 2021-06-01
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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  • A kind of pelvic floor biological repair mesh and preparation method thereof
  • A kind of pelvic floor biological repair mesh and preparation method thereof
  • A kind of pelvic floor biological repair 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 bio-repair mesh and a preparation method thereof. The pelvic-bottom bio-patch uses animal tissues as raw materials, removes immune components such as cells and DNA, cuts into thin strips, twists them into threads, and weaves them into patches. The decellularized material is twisted into a thread to obtain greater strength so that it is not so easy to break, and after weaving, because there is interweaving between the thread and the thread, the external force of stretching and tearing does not act on one point but on multiple interweaving points , so it has good mechanical properties, which solves the shortcomings of poor mechanical strength and the need to introduce cross-linking agents or synthetic materials for the pelvic floor biological patch of acellular material, and the structure of the mesh is made by a weaving process, and the pore size of the mesh is The size can be easily adjusted by weaving parameters to meet the needs of practical applications. At the same time, the pelvic floor biological patch retains the original three-dimensional structure, non-collagen protein and growth factors in the extracellular matrix, and promotes the functional reconstruction of tissues and postoperative healing.

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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Patent Type & Authority Patents(China)
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