Preloaded biological heart valve capable of rapidly rehydrating and preparation method thereof

Abstract

The invention discloses a preloaded biological heart valve capable of rapidly rehydrating and a preparation method thereof. The preparation method comprises the following steps: crosslinking treatment, immersing a biofilm sheet in glutaraldehyde aqueous solution for crosslinking reaction; Hydrophilic treatment, wherein the biofilm sheet is immersed in a solution containing hydrophilic molecules and a condensing agent, and the hydrophilic molecules are immobilized on the biofilm sheet by a chemical grafting method; and drying, drying the biofilm sheets which have been treated by hydrophilic treatment and cross-linking treatment, so as to obtain a preloaded biological heart valve which can be quickly rehydrated. The pre-loaded biological heart valve prepared by the preparation method of theinvention can realize rapid rehydration, and the creases after rehydration can be quickly flattened and convenient to use.

Description

technical field

[0001] The invention relates to the field of medical materials and medical devices, in particular to a pre-assembled biological heart valve capable of rapid rehydration and a preparation method thereof. Background technique

[0002] A prosthetic valve is an artificial organ that can be implanted in the heart to replace the heart valve and has the function of a natural heart valve. When the heart valve disease is too serious to recover or improve the function of the valve by valve separation surgery or repair surgery, artificial heart valve replacement must be used. With the advancement of technology in the 21st century, the application trend of transcatheter valve implantation is increasing worldwide. Transcatheter bioprosthetic aortic valve implantation has the potential to reduce mortality and morbidity compared with the high risks associated with conventional surgical valve replacement procedures. Transcatheter valve implantation as a less invasive, lowe...

Examples

Embodiment 1

[0042] The specific implementation steps are as follows: 1) After cleaning the porcine pericardial valve with deionized water, soak it for 2 days at 4°C in an aqueous solution of 50% polyglutamic acid and 1% condensing agent; 2. ) at 4°C for 7 days in a 5% glutaraldehyde solution; 3) at 4°C for 2 days in a 50% α-amino polyethylene glycol aqueous solution; 4) with After washing with deionized water, dry at 37°C for 1 day to obtain the target prefabricated biological heart valve material.

[0043] It was found through testing that the dry artificial biological heart valve prepared in this embodiment can achieve rapid rehydration, and the creases can be quickly flattened after rehydration. At the same time, it can still maintain good flexibility in a dry state and has excellent mechanical properties and biocompatibility.

Embodiment 2

[0045] The specific implementation steps are as follows: 1) After the bovine pericardial valve is cleaned with deionized water, soak it for 2 days at 4°C in an aqueous solution of 50% polyglutamic acid and 5% condensing agent; 2. ) at 4°C for 7 days in a 5% glutaraldehyde solution; 3) at 4°C for 2 days in a 50% α-amino polyethylene glycol aqueous solution; 4) with After washing with deionized water, dry at 37°C for 3 days to obtain the target preinstallable biological heart valve material.

[0046] It was found through testing that the dry artificial biological heart valve prepared in this embodiment can achieve rapid rehydration, and the creases can be quickly flattened after rehydration. At the same time, it can still maintain good flexibility in a dry state and has excellent mechanical properties and biocompatibility.

Embodiment 3

[0048] The specific implementation steps are as follows: 1) After cleaning the porcine pericardial valve with deionized water, soak it in a glutaraldehyde solution with a concentration of 5% at 4°C for 7 days; % polyglutamic acid and a concentration of 5% condensing agent in an aqueous solution soaked for 5 days; 3) at 4 ° C, soaked in a concentration of 50% α-amino polyethylene glycol aqueous solution for 5 days; 4) with After being washed with deionized water, it was dried at 37°C for 5 days to obtain the target prefabricated biological heart valve material.

[0049] It was found through testing that the dry artificial biological heart valve prepared in this embodiment can achieve rapid rehydration, and the creases can be quickly flattened after rehydration. At the same time, it can still maintain good flexibility in a dry state and has excellent mechanical properties and biocompatibility.

technical field

[0001] The invention relates to the field of medical materials and medical devices, in particular to a pre-assembled biological heart valve capable of rapid rehydration and a preparation method thereof. Background technique

[0002] A prosthetic valve is an artificial organ that can be implanted in the heart to replace the heart valve and has the function of a natural heart valve. When the heart valve disease is too serious to recover or improve the function of the valve by valve separation surgery or repair surgery, artificial heart valve replacement must be used. With the advancement of technology in the 21st century, the application trend of transcatheter valve implantation is increasing worldwide. Transcatheter bioprosthetic aortic valve implantation has the potential to reduce mortality and morbidity compared with the high risks associated with conventional surgical valve replacement procedures. Transcatheter valve implantation as a less invasive, lowe...

Examples

Embodiment 1

[0042] The specific implementation steps are as follows: 1) After cleaning the porcine pericardial valve with deionized water, soak it for 2 days at 4°C in an aqueous solution of 50% polyglutamic acid and 1% condensing agent; 2. ) at 4°C for 7 days in a 5% glutaraldehyde solution; 3) at 4°C for 2 days in a 50% α-amino polyethylene glycol aqueous solution; 4) with After washing with deionized water, dry at 37°C for 1 day to obtain the target prefabricated biological heart valve material.

[0043] It was found through testing that the dry artificial biological heart valve prepared in this embodiment can achieve rapid rehydration, and the creases can be quickly flattened after rehydration. At the same time, it can still maintain good flexibility in a dry state and has excellent mechanical properties and biocompatibility.

Embodiment 2

[0045] The specific implementation steps are as follows: 1) After the bovine pericardial valve is cleaned with deionized water, soak it for 2 days at 4°C in an aqueous solution of 50% polyglutamic acid and 5% condensing agent; 2. ) at 4°C for 7 days in a 5% glutaraldehyde solution; 3) at 4°C for 2 days in a 50% α-amino polyethylene glycol aqueous solution; 4) with After washing with deionized water, dry at 37°C for 3 days to obtain the target preinstallable biological heart valve material.

[0046] It was found through testing that the dry artificial biological heart valve prepared in this embodiment can achieve rapid rehydration, and the creases can be quickly flattened after rehydration. At the same time, it can still maintain good flexibility in a dry state and has excellent mechanical properties and biocompatibility.

Embodiment 3

[0048] The specific implementation steps are as follows: 1) After cleaning the porcine pericardial valve with deionized water, soak it in a glutaraldehyde solution with a concentration of 5% at 4°C for 7 days; % polyglutamic acid and a concentration of 5% condensing agent in an aqueous solution soaked for 5 days; 3) at 4 ° C, soaked in a concentration of 50% α-amino polyethylene glycol aqueous solution for 5 days; 4) with After being washed with deionized water, it was dried at 37°C for 5 days to obtain the target prefabricated biological heart valve material.

[0049] It was found through testing that the dry artificial biological heart valve prepared in this embodiment can achieve rapid rehydration, and the creases can be quickly flattened after rehydration. At the same time, it can still maintain good flexibility in a dry state and has excellent mechanical properties and biocompatibility.