Heart valve bioprosthesis and manufacturing method thereof

• US 10,470,879 B2
• Filed: 03/02/2016
• Issued: 11/12/2019
• Est. Priority Date: 04/20/2015
• Status: Active Grant

• Current Assignee: Hangzhou Innocardiac Medical Technology Company Limited
• Original Assignee: Hangzhou Jiahezhongbang Biotechnology Company Limited
• Inventors: Zhao, Yimin, Zhang, Hao
• Primary Examiner(s): Prebilic, Paul B
• Application Number:
  US15/568,064
• Publication Number:
  US 20180133002A1
• Time in Patent Office: 1,350 Days
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61L 27/3625 Vascular tissue, e.g. heart valves

Abstract

A heart valve bioprosthesis (100) and a manufacturing method thereof are provided. The heart valve bioprosthesis (100) comprises: a support frame (1), valve leaflets (2) and a valve auxiliary structure. The valve leaflets (2) are connected to the valve auxiliary structure, the valve auxiliary structure is connected to the support frame (1). Both the valve leaflets (2) and the valve auxiliary structure are made of biological tissues. The support frame (1) is formed as a single component with an elastic material, and the valve auxiliary structure is preset with suturing marks. The heart valve bioprosthesis improves the biocompatibility with the human body, reduces the total height of the valve, shortens the suturing time, and decreases the possibility of thrombus or bacterial attachment thereto. In addition, the heart valve bioprosthesis is made by a simple process, exhibit excellent compliance with the cardiac tissue, and has a prolonged service life.

Claims

1. A heart valve bioprosthesis comprising a support frame, valve leaflets and a valve auxiliary structure, said valve leaflets are connected to the valve auxiliary structure, and said valve auxiliary structure is connected to the support frame;

wherein

said valve leaflets are made from animal pericardium or porcine aortic valve leaflets;

said valve auxiliary structure is made from animal pericardium and comprises a suture ring and a covering material, said covering material comprising an inner covering and an outer covering;

wherein said support frame is placed within a space formed between the inner covering and the outer covering;

said valve leaflets, said suture ring and said covering material are preset with suturing marks so that the distance between two adjacent suturing marks is 0.5-3 mm;

wherein suturing along the suturing marks produces said heart valve bioprosthesis;

said support frame is made of an elastic material; and

said suture ring is for suturing to cardiac tissues.

2. The heart valve bioprosthesis of claim 1, wherein the valve leaflets are connected to the covering material, and the covering material and the suture ring are fixed directly or indirectly on the support frame.

3. The heart valve bioprosthesis of claim 2, wherein the valve leaflets are connected to the inner covering.

4. The heart valve bioprosthesis of claim 1, wherein the suturing marks are suturing holes.

5. The heart valve bioprosthesis of claim 1, wherein the support frame is formed as a single component.

6. The heart valve bioprosthesis of claim 1, wherein the support frame is made of polyformaldehyde (POM), polyetheretherketone (PEEK), polysulfone (PSF), Co-based alloy, Ti-based alloy, or Ni—

Ti alloy.

7. The heart valve bioprosthesis of claim 1, wherein the animal pericardium is bovine, equine, porcine, ovine, caprine, or asinine pericardium.

8. A method of manufacturing the heart valve bioprosthesis of claim 1, comprising the following steps:

a) providing a support frame, valve leaflets, a suture ring and a covering material;

b) presetting suturing marks on the valve leaflets, the suture ring and the covering material;

c) suturing the valve leaflets to the covering material along the suturing marks, and fixing the sutured valve leaflets and covering material to the support frame; and

d) fixing the suture ring to the support frame to form said heart valve bioprosthesis.

9. The method of claim 8, wherein step c) comprises suturing the valve leaflets to the inner covering and then suturing the outer covering to the inner covering to form upper and lower edges of the covering material.

10. The method of claim 9, wherein step c) further comprises placing the support frame into a space formed between the inner covering and the outer covering.

11. The method of claim 9, wherein step c) comprises suturing the valve leaflets to a top edge of the inner covering and suturing a top edge of the outer side covering to the top edge of the inner side covering to form said upper edge of the covering material;

and suturing a lower edge of the inner side covering to a lower edge of the outer covering to form said lower edge of the covering material;

wherein the support frame is enclosed in a space formed between the inner covering, the outer covering and the upper and lower edges of the covering material.

12. The method of claim 8, wherein when the support frame comprises a valve ring and a valve ridge which are formed as a single component;

step d) comprises suturing the suture ring to an outer edge of said valve ring.

13. The method of claim 8, wherein the suturing marks are suturing holes.