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Valve with anti-thrombosis and anti-calcification functions, and preparation method and application of valve

An anti-thrombotic and valve technology, applied in the field of medical materials, can solve the problems of calcification and heart valve thrombosis, and achieve the effect of reducing calcification, improving biocompatibility and anti-calcification ability, and preventing the thickening of valve leaflets.

Active Publication Date: 2020-09-25
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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  • Valve with anti-thrombosis and anti-calcification functions, and preparation method and application of valve
  • Valve with anti-thrombosis and anti-calcification functions, and preparation method and application of valve
  • Valve with anti-thrombosis and anti-calcification functions, and preparation method and application of valve

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1～3

[0029] A valve with anti-thrombotic and anti-calcification functions is prepared through the following steps:

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

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

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

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 measured with 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 after zwitterion modification 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 performance of valve material

[0042] The valve material prepared in the examples and the valve material without zwitterion modification were cut into 1 square centimeter sheets, implanted subcutaneously in SD rats for 90 days and then taken out, 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 after zwitterion modification is weaker than that of the biological valve after glutaraldehyde cross-linking, 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-MPC14.9 AMA-SBMA15.2 AMA-CBMA15.5 Glutaraldehyde cross-linked biological valve120.6

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Abstract

The present invention discloses a valve with anti-thrombosis and anti-calcification functions, and a preparation method and an application of the valve. The valve comprises a valve base and a zwitterionic copolymer covalently connected to the valve base. During preparation, the valve base is firstly soaked in a glutaraldehyde solution to obtain a cross-linked valve; and then the cross-linked valveis soaked in a zwitterionic polymer solution with a concentration of 0.1-5 wt% for reaction for 2-4 days, and then reduction with a reducing agent is conducted to obtain the valve with the anti-thrombosis and anti-calcification functions. The valve material is subjected to anti-thrombosis and anti-calcification treatments, so that after the valve is implanted in patients, risks of valve leaflet thrombosis can be reduced, valve leaflet thickening and transvalvular differential pressure increase are prevented, a long-term hydrodynamic performance is improved, patients can avoid or reduce uses of anticoagulant and antiplatelet drugs, risks of patient bleeding are reduced, besides, aldehyde residues in the valve leaflet tissues are reduced, biocompatibility and anti-calcification ability areimproved, and ultimately complications of valve leaflet thrombosis are reduced and service life of the valve is extended.

Description

Technical field [0001] The invention belongs to the technical field of medical materials, and specifically relates to a valve with anti-thrombosis and anti-calcification functions, and a preparation method and application thereof. Background technique [0002] The valves in the human blood circulation system control the one-way flow of blood flow in the human body. Patients with severe valve diseases will experience heart failure or even death. Their treatment requires artificial valve replacement. Among them, biological valves have good biocompatibility. The hemodynamics is good, and the utilization rate is increasing year by year. Bioprostheses mainly include surgical bioprostheses and intervention bioprostheses, the latter of which does not require thoracotomy and the patient recovers quickly, which represents the future development direction of bioprostheses. However, biological valves still have problems with calcification and leaflet thrombosis, which shortens the life of ...

Claims

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Application Information

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Patent Type & Authority Applications(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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