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Non-glutaraldehyde pre-installable dry biological valve material and preparation method and application thereof

A biological valve, glutaraldehyde technology, applied in the direction of tissue regeneration, medical science, prosthesis, etc., can solve the problems of inability to protect elastin, residue of glutaraldehyde aldehyde group, and inability to quickly expand, etc., to achieve good anti-calcification performance and Effects of elastin stability, easy calcification, and avoidance of glutaraldehyde residues

Active Publication Date: 2020-05-19
VENUS MEDTECH (HANGZHOU) INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

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

Method used

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  • Non-glutaraldehyde pre-installable dry biological valve material and preparation method and application thereof

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Effect test

Embodiment 1

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

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

[0036] b. Soak the decellularized pericardium material in 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 above step in a 0.1M aqueous solution of 3-propyl methacrylate and incubate at 37° C. for 24 hours.

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

[0039] e. Using a mixed solution of 60 mM carbodiimide and 12 mM N-hydroxysuccinimide, soak the material obtained ...

Embodiment 2

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

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

[0045] b. Soak the decellularized pericardium material in 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 above step in a 0.1M aqueous solution of 3-propyl methacrylate and incubate at 37° C. for 24 hours.

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

[0048] e. Using a mixed solution of 60 mM carbodiimide and 12 mM N-hydroxysuccinimide, soak the material obtained i...

Embodiment 3

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

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

[0054] b. Soak the decellularized pericardium material in 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 above step in a 0.2M aqueous solution of 3-propyl methacrylate and incubate at 37° C. for 24 hours.

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

[0057] e. Using a mixed solution of 50 mM carbodiimide and 15 mM N-hydroxysuccinimide, soak the material obtained ...

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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 in particular relates to a non-glutaraldehyde prepacked dry biological valve material, a preparation method and an application. Background technique [0002] The artificial bio-heart valve materials currently on the market are mainly made of pig or bovine pericardium as a raw material, and are prepared by cross-linking with glutaraldehyde solution. Moreover, the bioprosthetic valve prepared by glutaraldehyde-crosslinked pericardium has a service life of only about 10 years due to problems such as residual glutaraldehyde aldehyde groups, calcification, and 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-crosslinked biological heart valves, many methods have been used to improve or replace glutaraldehyde crosslinking. F...

Claims

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Application Information

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Patent Type & Authority Applications(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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