Heart valve prosthesis for percutaneous replacement of a tricuspid valve, and system comprising a heart valve prosthesis of said type

• US 10,660,749 B2
• Filed: 01/17/2017
• Issued: 05/26/2020
• Est. Priority Date: 07/16/2014
• Status: Active Grant

• Current Assignee: Medira AG
• Original Assignee: NVT AG (Blue Sail Medical Co., Ltd.)
• Inventors: Figulla, Hans Reiner, Lauten, Alexander
• Primary Examiner(s): Scherbel, Todd J
• Application Number:
  US15/407,313
• Publication Number:
  US 20170165061A1
• Time in Patent Office: 1,225 Days
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• CPC Class Codes: A61F 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol

Abstract

The invention relates to a heart valve prosthesis for percutaneous replacement of a tricuspid valve including a stent-type support structure and a biological heart valve; the stent-type support structure can autonomously expand from a radially compressed state into a radially expanded state and includes a fluid-tight cover which extends like a tube over at least some portions of the support structure; the heart valve is arranged in a lateral opening in the support structure. Embodiments further relate to a system including a heart valve prosthesis of said type.

Claims

1. A heart valve prosthesis, for the percutaneous supplementation or replacement of an organic tricuspid valve, the heart valve prosthesis having an overall tubular form and comprising:

a stent-type support structure and a biological heart valve,

the stent-type support structure configured to autonomously expand from a radially compressed state into a radially expanded state; and

a fluid-tight tubular covering extending over a circumference of at least longitudinally central portions of the stent-type support structure, wherein

the biological heart valve is disposed in a lateral opening formed in a common tubular wall plane of both the stent-type support structure and the fluid-tight tubular covering, the lateral opening extending through a tubular wall of the stent-type support structure and the fluid-tight tubular covering to form an exit from an inner tubular lumen of the heart valve prosthesis,

the biological heart valve is disposed within the lateral opening and occluding the lateral opening;

the heart valve prosthesis is configured to form an overall tubular connection extending between the superior vena cava and the inferior vena cava of an organic heart, and

when the stent-type support structure is in the radially expanded state, a circumference of the stent-type support structure at one or more of an end of the heart valve prosthesis corresponding to the superior vena cava and an end of the heart valve prosthesis corresponding to the inferior vena cava is at least as large as a transverse circumference of the stent-type support structure and the fluid-tight tubular covering both immediately above the lateral opening and Immediately below the lateral opening.

2. The heart valve prosthesis according to claim 1, characterized in that the lateral opening, arranged in the plane with the tubular wall, follows a curvature of the tubular wall or a course of the common wall plane.

3. The heart valve prosthesis according to claim 1, characterized in that the stent-type support structure comprises two axially longitudinal-axially end sections adapted respectively to anchoring in the superior vena cava and inferior vena cava of the organic heart.

4. The heart valve prosthesis according to claim 3, characterized in that the stent-type support structure comprises an atrium section that extends between the axially longitudinal end sections.

5. The heart valve prosthesis of claim 4, characterized in that the atrium section is of a length that corresponds to a distance between the superior vena cava and the inferior vena cava of the organic heart.

6. The heart valve prosthesis according to claim 4, characterized in that the lateral opening, corresponding to the biological heart valve, is arranged in the atrium section of the stent-type support structure.

7. The heart valve prosthesis according to claim 1, characterized in that the stent-type support structure comprises a wire mesh and/or laser-cut lattice structure respectively enclosing closed meshes or cells.

8. The heart valve prosthesis according to claim 1, characterized in that the stent-type support structure comprises a segment without any tubular covering and permeable to blood, disposed at least at one axially longitudinal-end.

9. The heart valve prosthesis according to claim 8, wherein the stent-type support structure comprises wire mesh and/or laser-cut lattice structure, and characterized in that the segment without any tubular covering and permeable to blood comprises a wire mesh and/or laser-cut lattice structure of a larger mesh size than a mesh size of other wire mesh and/or laser-cut lattice structures of the stent-type support structure.

10. The heart valve prosthesis according to claim 1, characterized in that the biological heart valve is firmly attached to the stent-type support structure within the lateral opening.

11. The heart valve prosthesis according to claim 10, characterized in that the fluid-tight tubular covering is attached in a fluid-tight manner to the biological heart valve fixed in the lateral opening.

12. The heart valve prosthesis according to claim 1, characterized in that the stent-type support structure comprises a shape-memory material and/or a superelastic material.

13. The heart valve prosthesis according to claim 12, characterized in that the shape-memory material and/or the superelastic material comprises a nickel-titanium alloy.

14. The heart valve prosthesis according to claim 13, characterized in that the nickel-titanium alloy comprises Nitinol.

15. The heart valve prosthesis according to claim 1 in combination with a catheter,

wherein the heart valve prosthesis is configured to be inserted in the radially compressed state by the catheter to position the heart valve prosthesis in the radially compressed state, wherein the heart valve prosthesis is implantable into an organic heart by the catheter percutaneously, and

wherein there is a diameter ratio between the radially compressed state and the radially expanded state.

16. The heart valve prosthesis according to claim 15, characterized in that the heart valve prosthesis is implantable into the organic heart transluminally.

17. The heart valve prosthesis according to claim 16, characterized in that the heart valve prosthesis is implantable into the organic heart transfemorally.

18. A method of using the heart valve prosthesis of claim 15, comprising implanting the heart valve prosthesis into the organic heart by the catheter.