Dry biological tissue material and preparation method thereof

A biological tissue, dry state technology, applied in the field of medical devices, can solve the problems of reduced mechanical properties of biological tissue materials, inconvenient storage and use of biological tissue, difficult control of water content, etc. Error probability, effect of shortening operation time

Active Publication Date: 2019-09-03
SHANGHAI MICROPORT CARDIOFLOW MEDTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The object of the present invention is to provide a dry biological tissue material and its preparation method to solve the problems of inconvenient storage and use of biological tissue prepared in the prior art, difficult control of water content, low biological safety, and the At least one of the problems of reduced mechanical properties of the material

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  • Dry biological tissue material and preparation method thereof
  • Dry biological tissue material and preparation method thereof
  • Dry biological tissue material and preparation method thereof

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preparation example Construction

[0045] figure 1 It is a schematic flowchart of a method for preparing a dry biological tissue material provided by an embodiment of the present invention. Please refer to figure 1 , a method for preparing a dry biological tissue material of the present application, comprising:

[0046] Step S1: washing the cross-linked biological tissue;

[0047] Step S2: balancing the biological tissue treated in step S1 with a vitrification solution;

[0048] Step S3: freeze-drying the biological tissue treated in step S2;

[0049] Step S4: sealing and packaging the biological tissue treated in step S3, and then sterilizing it to obtain the dry biological tissue material.

[0050] Wherein, in the present invention, the cross-linked biological tissue in the step S1 is a heterogeneous or allogeneic biological tissue after cross-linking with a cross-linking agent, such as pericardium, heart valve, membrane, pleura, small intestine, etc. Submucosa, dura mater, dura mater, ligaments, or skin...

Embodiment 1

[0066] In this embodiment, the biological tissue material is selected from bovine pericardium tissue, and the preparation method of the dry biological tissue material is as follows:

[0067] Step 1.1: Bovine pericardium tissue was obtained from a local slaughterhouse, and after fat stripping, trimming and cleaning, it was cross-linked and fixed with 0.625% glutaraldehyde (Sigma-Aldrich Co. LLC.) solution for 5 days. The cross-linked and fixed bovine pericardium was cut into small pieces (15mm*15mm), and the small pieces of bovine pericardium tissue were washed with normal saline (Huaren Pharmaceutical Co., Ltd.) at room temperature for 3 times, each time for 3-5 minutes.

[0068] Step 1.2: immerse the bovine pericardium in a 50% glycerol solution by mass and wash it three times, each time for 5-10 minutes;

[0069] Step 1.3: Take out the tissue treated in step 1.2, and transfer it into a trehalose solution with a mass percentage of 60% to equilibrate for 12 hours;

[0070] St...

Embodiment 2

[0079] In this embodiment, the biological tissue material is selected from porcine pericardium tissue, and the preparation method of the dry biological tissue material is as follows:

[0080]Step 2.1: Obtain porcine pericardium tissue from a local slaughterhouse, undergo fat stripping, trimming and cleaning, and then use N-hydroxysuccinic acid imide to cross-link and fix it. Specifically, prepare a cross-linking solution with PBS at pH=5.5, and N-hydroxysuccinic acid The concentration of imine is 0.1mol / L, and the porcine pericardium and the cross-linking solution are mixed at a ratio of 8:1 (W / V); at 20°C, cross-link at 400r / min for 16h; then shake and wash 8 times, each time for 10min . The fixed porcine pericardium was cut into small pieces (30 mm*50 mm), and then the cross-linked and fixed porcine pericardium was washed with physiological saline at room temperature for 3 to 5 times, each time for 3 to 5 minutes.

[0081] Step 2.2: immerse the pig pericardium in a 65% ethy...

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Abstract

The invention provides a dry biological tissue material and a preparation method thereof. The preparation method comprises the following steps: S1, cleaning a biological tissue subjected to cross-linking treatment; S2, balancing the biological tissue treated in the S1 with a vitrification solution; S3, carrying out freeze-drying treatment of the biological tissue treated in the S2; and S4, sealingand packaging the biological tissue treated in the S3 and sterilizing to obtain the dry biological tissue material. The invention provides the dry biological tissue material and the preparation method thereof. By the treatment method of vitrification solution balance and freeze-drying, the water solution in the biological tissue material keeps a glassy state during cooling treatment, ice crystalscannot be formed, damage to a structure of collagen fibers is avoided, and the dry biological tissue material has good protective effect on a three-dimensional structure of the tissue; the morphologyand tensile strength of the biological tissue obtained by the method cannot be changed significantly.

Description

technical field [0001] The invention belongs to the field of medical devices, and relates to a dry biological tissue material and a preparation method thereof. Background technique [0002] At present, biological tissue materials such as biological valves and biological patches used in clinical practice are usually cross-linked and fixed with chemical reagents such as glutaraldehyde and / or formaldehyde, and stored in a storage medium containing glutaraldehyde and / or formaldehyde. in a dilute aqueous solution to keep it sterile and hydrated. However, a large number of studies have proved that the biological tissues treated with glutaraldehyde cross-linking have the following defects: glutaraldehyde has high toxicity, and even a very low residual amount will have a great impact on the human body, which is not conducive to the endothelium of biological tissues. After the biological tissue is implanted into the human body, the residual glutaraldehyde will cause the immune respo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L27/36A01N1/02
CPCA01N1/021A61L27/3604A61L27/3687A61L27/3691A61L2430/40A01N1/00A01N1/02A61L27/36
Inventor 张泉娟赵婧陈国明李雨
Owner SHANGHAI MICROPORT CARDIOFLOW MEDTECH CO LTD
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