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A non-glutaraldehyde prepackaged dry biological valve material and its preparation method and application

A bio-valve, glutaraldehyde technology, applied in tissue regeneration, medical science, prosthesis and other directions, can solve the problems of inability to protect elastin, glutaraldehyde aldehyde residues, and inability to spread quickly, and achieve good anti-calcification performance and Elastin stability, solving the effect of easy calcification, avoiding the problem of glutaraldehyde aldehyde residue

Active Publication Date: 2020-10-30
VENUS MEDTECH (HANGZHOU) INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0005] The purpose of the present invention is to provide a non-glutaraldehyde prepackaged dry biological valve material in order to solve the problems of residual glutaraldehyde aldehyde group, easy calcification, inability to protect elastin, and dry valve material that cannot be flattened quickly after being pressed. And preparation method and application

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  • A non-glutaraldehyde prepackaged dry biological valve material and its preparation method and application

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Effect test

Embodiment 1

[0034] A preferred embodiment of the present invention provides a method for preparing a non-glutaraldehyde preloaded dry biological valve material, the specific steps are as follows:

[0035] a. Soak the porcine pericardium in a 0.1wt% disodium ethylenediaminetetraacetic acid solution for 1h, then soak in a 0.1wt% sodium lauryl sulfate solution for 24h, then rinse in a sterile PBS solution for 1h .

[0036] b. Soak the decellularized pericardium material in a 5wt% glycidyl methacrylate solution and incubate at 37°C for 3 days to introduce a carbon-carbon double bond structure.

[0037] c. Soak the material obtained in the previous step in a 0.1M 3-sulfonic acid propyl methacrylate aqueous solution at 37°C and incubate for 24 hours.

[0038] d. Add 20mM ammonium persulfate and 20mM sodium bisulfite aqueous solution to the material obtained in the previous step for crosslinking at 37°C for 24h.

[0039] e. Use a mixed solution of 60mM carbodiimide and 12mM N-hydroxysuccinimide to immers...

Embodiment 2

[0043] A preferred embodiment of the present invention provides a method for preparing a non-glutaraldehyde preloaded dry biological valve material, the specific steps are as follows:

[0044] a. Soak the porcine pericardium in a 0.1wt% disodium ethylenediaminetetraacetic acid solution for 1h, then soak in a 0.1wt% sodium lauryl sulfate solution for 24h, then rinse in a sterile PBS solution for 1h .

[0045] b. Soak the acellular pericardium material in a 2wt% glycidyl methacrylate solution and incubate at 37°C for 3 days to introduce a carbon-carbon double bond structure.

[0046] c. Soak the material obtained in the previous step in a 0.1M 3-sulfonic acid propyl methacrylate aqueous solution at 37°C and incubate for 24 hours.

[0047] d. Add 20mM ammonium persulfate and 20mM sodium bisulfite aqueous solution to the material obtained in the previous step for crosslinking at 37°C for 24h.

[0048] e. Use a mixed solution of 60mM carbodiimide and 12mM N-hydroxysuccinimide to immerse the...

Embodiment 3

[0052] A preferred embodiment of the present invention provides a method for preparing a non-glutaraldehyde preloadable dry biological valve material, and the specific steps are as follows:

[0053] a. Soak the porcine pericardium in 0.2wt% disodium ethylenediaminetetraacetic acid solution for 1h, then soak in 0.2wt% sodium lauryl sulfate solution for 20h, and then rinse in sterile PBS solution for 3h .

[0054] b. Soak the decellularized pericardium material in an 8wt% glycidyl methacrylate solution and incubate at 37°C for 4 days to introduce a carbon-carbon double bond structure.

[0055] c. Soak the material obtained in the previous step in a 0.2M 3-sulfonic acid propyl methacrylate aqueous solution at 37°C and incubate for 24 hours.

[0056] d. Add 20mM ammonium persulfate and 20mM sodium bisulfite aqueous solution to the material obtained in the previous step for crosslinking at 37°C for 24h.

[0057] e. Use a mixed solution of 50 mM carbodiimide and 15 mM N-hydroxysuccinimide to...

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Abstract

The present invention discloses a non-glutaraldehyde pre-installable dry biological valve material and a preparation method and an application thereof, and belongs to the technical field of medical materials. The preparation method comprises the following specific steps: a, decellularizing a pig or bovine pericardium material; b, soaking the decellularized pericardium in a glycidyl methacrylate oracrylic anhydride solution to introduce a carbon-carbon double bond structure; c, soaking the material in an aqueous solution of propyl methacrylate 3-sulfonate; d, adding an initiator for double bond polymerization cross-linking; e, using a mixed solution of carbodiimide and N-hydroxysuccinimide for cross-linking fixation; f, soaking the material in a polyphenol solution; and g, conducting storage with a micro-organism-inhibiting solution after rinsing or with an alcohol solution after dehydration drying. The preparation method can avoid problems of glutaraldehyde aldehyde group residues, easy calcification, and inability to protect elastin, at the same time, can effectively solve a problem that the dry valve material cannot be quickly flattened after being pressed and held, and potentially extends service life.

Description

Technical field [0001] The invention belongs to the technical field of medical materials, and specifically relates to a non-glutaraldehyde preloadable dry biological valve material, and a preparation method and application thereof. Background technique [0002] The current artificial biological heart valve materials on the market mainly use porcine or bovine pericardium as raw materials and are made by cross-linking with glutaraldehyde solution. In addition, the artificial biological valve prepared from the pericardium cross-linked by glutaraldehyde has a current service life of only about 10 years due to the residual glutaraldehyde aldehyde group, calcification, and the inability to protect elastin. Based on this, the development of new biological valve materials has important clinical value and social significance. [0003] In order to overcome the shortcomings of glutaraldehyde cross-linked biological heart valves, many methods have been used to improve or replace glutaraldehyd...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61L27/36A61L27/50
CPCA61L27/3625A61L27/3687A61L27/3691A61L27/50A61L2430/20A61L2430/40
Inventor 雷洋王云兵郭高阳杨立
Owner VENUS MEDTECH (HANGZHOU) INC
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