Pre-loadable biological heart valve capable of rapid rehydration and preparation method thereof

Patent metadata

Field	Value
Publication number	US-12102733-B2
Application number	US-202117313910-A
Country	US
Kind code	B2
Filing date	May 6, 2021
Priority date	Sep 19, 2018
Publication date	Oct 1, 2024
Grant date	Oct 1, 2024

Abstract

A method for preparing a pre-loadable biological heart valve capable of rapid rehydration includes performing a cross-linking treatment, wherein a biological valve is cross-linked by soaking in an aqueous glutaraldehyde solution; performing a hydrophilic treatment, wherein the biological valve is soaked in a solution containing a hydrophilic molecule and a condensing agent, to allow the hydrophilic molecule to be immobilized on the biological valve by chemical grafting; and performing a drying treatment, wherein the biological valve after the hydrophilic treatment and the cross-linking treatment is dried to obtain the pre-loadable biological heart valve capable of rapid rehydration.

First claim

What is claimed is:

1. A method for preparing a pre-loadable biological heart valve capable of rapid rehydration, comprising:
performing a cross-linking treatment, wherein a biological valve is cross-linked by soaking in an aqueous glutaraldehyde solution;
performing a hydrophilic treatment, wherein the biological valve is soaked in a solution containing a hydrophilic molecule and a condensing agent, to allow the hydrophilic molecule to be immobilized on the biological valve by chemical grafting; and
performing a drying treatment, wherein the biological valve after the hydrophilic treatment and the cross-linking treatment is dried to obtain the pre-loadable biological heart valve capable of rapid rehydration;
wherein the cross-linking treatment is performed and completed first, then the hydrophilic treatment is performed, and finally the drying treatment is performed; or, the hydrophilic treatment is performed and completed first, then the cross-linking treatment is performed, and finally the drying treatment is performed.

2. The method for preparing a pre-loadable biological heart valve capable of rapid rehydration according to claim 1 , wherein the hydrophilic molecule is a hydrophilic molecule containing an amino group or a carboxyl group.

3. The method for preparing a pre-loadable biological heart valve capable of rapid rehydration according to claim 2 , wherein the hydrophilic molecule comprises one or more of sodium glycinate, sodium alanine, sodium lysine, sodium glutamate, sodium aspartate, aminoethanol, tromethamine and diglycolamine.

4. The method for preparing a pre-loadable biological heart valve capable of rapid rehydration according to claim 2 , wherein the hydrophilic molecule comprises one or more of α-aminopolyethylene glycol, polyethyleneimine, polyacrylic acid, and α-carboxypolyethylene glycol, water-soluble chitosan, sodium alginate, hyaluronic acid, polyglycine, polyalanine, polylysine, polyglutamic acid, polyarginine, collagen and gelatin.

5. The method for preparing a pre-loadable biological heart valve capable of rapid rehydration according to claim 1 , wherein the condensing agent comprises dicyclohexyl carbodiimide, N-hydroxysuccinimide, 1-(3-dimethylaminopropyl)-3-ethyl carbodiimide, or 1-hydroxybenzotriazole; and of the condensing agent has a concentration in a range of 0.1 to 20% by weight.

6. The method for preparing a pre-loadable biological heart valve capable of rapid rehydration according to claim 1 , wherein in the hydrophilic treatment step, the hydrophilic molecule in the solution has a concentration in a range of 5 to 50% by weight.

7. The method for preparing a pre-loadable biological heart valve capable of rapid rehydration according to claim 6 , wherein in the hydrophilic treatment step, a reaction temperature for the chemical grafting is in a range of 4 to 37° C., and a reaction time is in a range of 1 to 7 days.

8. The method for preparing a pre-loadable biological heart valve capable of rapid rehydration according to claim 1 , wherein in the cross-linking treatment step, glutaraldehyde in the aqueous glutaraldehyde solution has a concentration in a range of 0.1 to 10% by volume.

9. The method for preparing a pre-loadable biological heart valve capable of rapid rehydration according to claim 8 , wherein in the cross-linking treatment step, a temperature for the cross-linking treatment is in a range of 4 to 37° C., and a reaction time is in a range of 1 to 7 days.

10. The method for preparing a pre-loadable biological heart valve capable of rapid rehydration according to claim 1 , wherein in the drying treatment step, a drying temperature is in a range of 4 to 50° C., and a drying time is in a range of 1 to 7 days.

11. The method for preparing a pre-loadable biological heart valve capable of rapid rehydration according to claim 1 , wherein the method further comprises a step of washing the biological valve before the cross-linking treatment and the hydrophilic treatment.

12. The method for preparing a pre-loadable biological heart valve capable of rapid rehydration according to claim 11 , wherein the step of washing the biological valve comprises: washing a fresh biological valve with deionized water at 3 to 5° C. with shaking at 80 to 120 rpm for 1.5 to 3 hrs.

13. A method for preparing a pre-loadable biological heart valve capable of rapid rehydration, comprising:
performing a cross-linking treatment, wherein a biological valve is cross-linked by soaking in an aqueous glutaraldehyde solution;
before and after the cross-linking treatment, performing at least one hydrophilic treatment, wherein in the hydrophilic treatment, the biological valve is soaked in a solution containing a hydrophilic molecule and a condensing agent, to allow the hydrophilic molecule to be immobilized on the biological valve by chemical grafting; and
finally performing a drying treatment, wherein the biological valve after the hydrophilic treatment and the cross-linking treatment is dried to obtain the pre-loadable biological heart valve capable of rapid rehydration.

14. The method for preparing a pre-loadable biological heart valve capable of rapid rehydration according to claim 13 , wherein the hydrophilic molecule is a hydrophilic molecule containing an amino group or a carboxyl group.

15. The method for preparing a pre-loadable biological heart valve capable of rapid rehydration according to claim 14 , wherein the hydrophilic molecule comprises one or more of sodium glycinate, sodium alanine, sodium lysine, sodium glutamate, sodium aspartate, aminoethanol, tromethamine and diglycolamine.

16. The method for preparing a pre-loadable biological heart valve capable of rapid rehydration according to claim 14 , wherein the hydrophilic molecule comprises one or more of α-aminopolyethylene glycol, polyethyleneimine, polyacrylic acid, and α-carboxypolyethylene glycol, water-soluble chitosan, sodium alginate, hyaluronic acid, polyglycine, polyalanine, polylysine, polyglutamic acid, polyarginine, collagen and gelatin.

17. The method for preparing a pre-loadable biological heart valve capable of rapid rehydration according to claim 13 , wherein the condensing agent comprises dicyclohexyl carbodiimide, N-hydroxysuccinimide, 1-(3-dimethylaminopropyl)-3-ethyl carbodiimide, or 1-hydroxybenzotriazole; and the condensing agent has a concentration in a range of 0.1 to 20% by weight.

18. The method for preparing a pre-loadable biological heart valve capable of rapid rehydration according to claim 13 , wherein in the hydrophilic treatment step, the hydrophilic molecule in the solution has a concentration in a range of 5 to 50% by weight, a reaction temperature for the chemical grafting is in a range of 4 to 37° C., and a reaction time is in a range of 1 to 7 days.

19. The method for preparing a pre-loadable biological heart valve capable of rapid rehydration according to claim 13 , wherein in the cross-linking treatment step, glutaraldehyde in the aqueous glutaraldehyde solution has a concentration in a range of 0.1 to 10% by volume, a temperature for the cross-linking treatment is in a range of 4 to 37° C., and a reaction time is in a range of 1 to 7 days.

20. The method for preparing a pre-loadable biological heart valve capable of rapid rehydration according to claim 13 , wherein in the drying treatment step, a drying temperature is in a range of 4 to 50° C., and a drying time is in a range of 1 to 7 days.

Assignees

• Venus Medtech Hangzhou Inc
• Univ Sichuan

Inventors

• Wang Yunbing
• Li Gaocan
• Lei Yang
• Yang Li
• Lim Hou-Sen
• Kuang Dajun
• Yu Jincheng

Classifications

• A61L2430/40

  Preparation and treatment of biological tissue for implantation, e.g. decellularisation, cross-linking · CPC title

• A61L2430/20

  for reconstruction of the heart, e.g. heart valves · CPC title

• A61L2300/214

  Amino acids · CPC title

• A61L2400/18

  Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment · CPC title

• A61L27/50

  Materials characterised by their function or physical properties {, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials} · CPC title