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A valve with antithrombotic and anticalcification functions, its preparation method and application

An anti-thrombosis and valve technology, applied in the field of medical materials, can solve problems such as calcification and heart valve prone to thrombosis, and achieve the effects of preventing valve leaflet thickening, improving biocompatibility and anti-calcification ability, and reducing aldehyde residues

Active Publication Date: 2021-05-11
JILIN VENUS HAOYUE MEDICAL LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In summary, the existing technology cannot solve the problem of thrombosis and calcification in minimally invasive interventional heart valves at the same time.

Method used

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  • A valve with antithrombotic and anticalcification functions, its preparation method and application
  • A valve with antithrombotic and anticalcification functions, its preparation method and application
  • A valve with antithrombotic and anticalcification functions, its preparation method and application

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1～3

[0029] A valve with antithrombotic and anticalcification functions, which is prepared through the following steps:

[0030] S1: Wash the fresh porcine pericardium thoroughly with deionized water, and add PBS buffer to completely immerse the tissue;

[0031] S2: Add glutaraldehyde to the PBS buffer solution until the concentration of glutaraldehyde is 0.5-0.7 wt%, cross-link at room temperature for 6-8 days, then remove and clean to obtain cross-linked porcine pericardium;

[0032] S3: Soak the cross-linked porcine pericardium with a zwitterionic polymer solution with a concentration of 0.1-5wt%, wherein the zwitterionic polymer includes repeating units shown in formula (I) and formula (II), and the zwitterionic polymer is shown in the formula The molar ratio of the repeating unit shown in (II) is 0.1%-50%, and the rest is the repeating unit shown in formula (I). Porcine pericardium is immersed in the zwitterionic polymer solution at room temperature for 2 to 4 days, then take...

experiment example 1

[0037] Experimental Example 1: Anticoagulant performance of valve material

[0038] The valve material prepared in the example and the valve material without zwitterion modification were cleaned and cut into 8 mm diameter discs, and they were incubated with platelet-rich plasma for 1 hour, and then measured using a lactate dehydrogenase kit after cleaning The amount of platelet adsorption on the valve material is shown in Table 2. It can be seen from Table 2 that the anticoagulant performance of the biological valve modified by zwitterions is significantly higher than that of the unmodified biological valve,

[0039] Table 2 Adsorption of platelets on valve tissue

[0040] name of association Adsorption capacity AMA-MPC 0.5±0.3 AMA-SBMA 0.2±0.2 AMA-CBMA 0.4±0.2 Glutaraldehyde cross-linked biological valve 1.2±0.1

experiment example 2

[0041] Experimental Example 2: Anti-calcification properties of valve materials

[0042] The valve material prepared in the embodiment and the valve material without zwitterion modification were cut into sheets of 1 square centimeter, implanted subcutaneously in SD rats and taken out after 90 days, and the calcium content on the valve material was measured, the results are shown in Table 3 . It can be seen from Table 3 that the degree of calcification of the biological valve modified by zwitterions is weaker than that of the biological valve after glutaraldehyde crosslinking, indicating that the anti-calcification performance of the valve is significantly improved after zwitterion modification.

[0043] Table 3 Calcium content in biological tissues

[0044] name of association Calcium content (g / kg) AMA-MPC 14.9 AMA-SBMA 15.2 AMA-CBMA 15.5 Glutaraldehyde cross-linked biological valve 120.6

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Abstract

The invention discloses a valve with anti-thrombotic and anti-calcification functions and its preparation method and application. The valve comprises a valve base and a zwitterionic copolymer covalently connected to the valve base. During preparation, the valve base is soaked in glutaraldehyde solution first to obtain a cross-linked valve; then the cross-linked valve is placed in a zwitterionic polymer solution with a concentration of 0.1-5 wt% for 2-4 days, and then used The reducing agent is reduced to obtain a valve with antithrombotic and anticalcification functions. The valve material in the present invention has been treated with anti-thrombotic and anti-calcification treatment, so after being implanted in the patient's body, it can reduce the risk of valve leaflet thrombus formation, prevent valve leaflet thickening and increase in transvalvular pressure difference, improve long-term fluid mechanical properties, and patients can exempt or reduce taking Anticoagulant and antiplatelet drugs reduce the bleeding risk of patients, and reduce aldehyde residues in the leaflet tissue, improve biocompatibility and anti-calcification ability, and finally reduce the complications of valve leaflet thrombosis and prolong the service life of the valve.

Description

technical field [0001] The invention belongs to the technical field of medical materials, and in particular relates to a valve with antithrombotic and anticalcification functions, a preparation method and application thereof. Background technique [0002] The valves in the human blood circulation system control the one-way flow of blood in the human body. Patients with severe valvular diseases will suffer from heart failure or even die. The treatment requires artificial valve replacement. Among them, biological valves have good biocompatibility. Hemodynamics are good, and the usage rate is increasing year by year. Bioprosthetics mainly include surgical bioprostheses and interventional bioprostheses. The latter represents the development direction of bioprostheses in the future because it does not require thoracotomy and the patient recovers quickly. However, there are still problems of calcification and valve leaflet thrombosis in the use of biological valves, which shorten...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61L27/34A61L27/36A61L33/00A61L27/50A61L33/06
CPCA61L27/34A61L27/3625A61L27/50A61L33/0023A61L33/0041A61L33/064A61L2430/20A61L2430/40
Inventor 王云兵郭高阳
Owner JILIN VENUS HAOYUE MEDICAL LTD
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