HEART VALVE PROSTHESIS

• US 20160000559A1
• Filed: 02/25/2014
• Published: 01/07/2016
• Est. Priority Date: 02/25/2013
• Status: Abandoned Application

• Current Assignee: Shanghai Microport Cardioflow Medtech Co., Ltd. (MicroPort Scientific Corp.)
• Original Assignee: Shanghai MicroPort Medical (Group) Co., Ltd. (MicroPort Scientific Corp.)
• Inventors: LI, Yu, HUANG, Lei, LUO, Qiyi, CHEN, Guoming, HUANG, Feng, HAN, Jianchao, DUAN, Yihao, CHEN, Shaohui
• Application Number:
  US14/769,991
• Publication Number:
  US 20160000559A1
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/0036 differing in thickness

Abstract

A stent (1) used for a heart valve prosthesis and the heart valve prosthesis that includes the stent (1) and is used for heart valve replacement. The stent is configured to support a heart valve (3) and includes, along a longitudinal axis, an inflow section (8), an outflow section (6) and a transition section (7) between the inflow section (8) and the outflow section (6). The stent (1) has a contracted delivery configuration and an expanded deployed configuration. In the expanded deployed configuration, the inflow section (8) defines a concave contour that is complementary to a structure of a native valve annulus. The concave contour enables self-deployment and close adherence of the stent (1), thereby preventing its displacement and perivalvular leakage after implantation.

Claims

1. A stent for use in a heart valve prosthesis, the stent configured to support a heart valve and comprising, along a longitudinal axis, an inflow section, an outflow section and a transition section between the inflow section and the outflow section, the stent having a contracted delivery configuration and an expanded deployed configuration,

wherein in the expanded deployed configuration, the inflow section defines a concave contour that is complementary to a structure of a native valve annulus.

2. The stent according to claim 1, wherein the stent is a self-expanding stent comprising a mesh having a plurality of mesh cells.

3. The stent according to claim 2, wherein ones of the plurality of mesh cells in the inflow section corresponding to the concave contour are larger than remaining ones of the plurality of mesh cells in the inflow section.

4. The stent according to claim 1, wherein in the expanded deployed configuration, the stent conically tapers from the inflow section toward the transition section and flares from the transition section toward the outflow section.

5. The stent according to claim 1, wherein the inflow and outflow sections have ends slightly contracted so as to be tapered.

6. The stent according to claim 2, wherein the inflow section is circumferentially composed of twelve mesh cells.

7. The stent according to claim 2, wherein the ones of the plurality of mesh cells in the inflow section have a strut width greater than strut widths of ones of the plurality of mesh cells in the transition section and in the outflow section.

8. The stent according to claim 7, wherein the concave contour has a profile curvature radius of R4-R6 and a concave depth of 1-2 mm.

9. The stent according to claim 1, wherein the stent is fabricated from a nitinol alloy.

13. The stent according to claim 5, wherein an angle of the contraction ranges from 8°

to 12°

.

14. The stent according to claim 6, wherein adjacent struts of the inflow section intersect at an angle of 30°

-65°

.

15. The stent according to claim 2, wherein the outflow section is circumferentially composed of six mesh cells.

16. The stent according to claim 15, wherein adjacent struts of the outflow section intersect at an angle of 60°

-120°

.

17. The stent according to claim 15, wherein adjacent struts of the outflow section intersect at an angle of 55°

-65°

.

18. The stent according to claim 2, wherein a circumferential number of mesh cells increases gradually from 6 to 12 at the transition section.

19. The stent according to claim 2, wherein each of the mesh cells of the outflow section has an area of about 0.8-1.60 cm², and each of the mesh cells of the inflow section has an area of about 0.5-0.8 cm².

20. The stent according to claim 1, wherein the concave contour is located in the first and/or second stent ring on a side nearer to a proximal end of the stent.

10. A heart valve prosthesis for use in heart valve replacement, comprising:

a heart valve; and

a stem configured to support the heart valve and comprising, along a longitudinal axis, an inflow section, an outflow section and a transition section between the inflow section and the outflow section, the stent having a contracted delivery configuration and an expanded deployed configuration,

wherein in the expanded deployed configuration, the inflow section defines a concave contour that is complementary to a structure of a native valve annulus.

11. The heart valve prosthesis according to claim 10, wherein the heart valve is a tri-leaflet valve sewn from a one-way tri-leaflet pericardial valve formed of porcine pericardium that has been treated with an anti-calcification treatment.

12. The heart valve prosthesis according to claim 10, wherein the heart valve is sewn onto the stent by medical sutures made of polyethylene terephthalate.