Percutaneously-deployable prosthetic tricuspid valve

Patent metadata

Field	Value
Publication number	US-10779936-B2
Application number	US-201615574683-A
Country	US
Kind code	B2
Filing date	May 11, 2016
Priority date	May 18, 2015
Publication date	Sep 22, 2020
Grant date	Sep 22, 2020

Abstract

Devices and methods for the treatment of heart conditions are provided herein. For example, this document provides devices and methods for treating tricuspid valve regurgitation by percutaneously implanting a prosthetic tricuspid valve.

First claim

What is claimed is:

1. A prosthetic tricuspid valve comprising:
a structural framework of one or more braided nitinol wires arranged in a frustoconical shape that extends from a proximal end of the structural framework to a distal end of the structural framework, wherein the structural framework flares outward in a distal direction such that the proximal end of the structural framework is smaller than the distal end of the structural framework, the structural framework arranged to define an outer surface and an inner open region;
a cuff disposed on a proximal end portion of the outer surface, the cuff comprising a flexible covering material;
a plurality of anchor features, the anchor features extending outward from the outer surface, the anchor features configured for piercing tissue; and
a valve assembly disposed within the inner open region, the valve assembly comprising three leaflets that are configured for coaptation with each other,
wherein the prosthetic tricuspid valve is reconfigurable between a low-profile delivery configuration for containment within a delivery catheter and an expanded deployed configuration.

2. The prosthetic tricuspid valve of claim 1 , wherein the structural framework has a linear outer wall profile between the proximal and distal ends of the structural framework.

3. The prosthetic tricuspid valve of claim 2 , wherein the structural framework defines a non-circular transverse cross-sectional shape.

4. The prosthetic tricuspid valve of claim 1 , wherein the flexible covering material comprises ePTFE or PTFE.

5. The prosthetic tricuspid valve of claim 1 , wherein at least some of the anchor features extend outward from the outer surface at angles in a range from about 50° to about 90°.

6. The prosthetic tricuspid valve of claim 1 , wherein at least some of the anchor features extend outward from the outer surface for distances in a range of about 0.6 mm to about 1.0 mm.

7. The prosthetic tricuspid valve of claim 1 , wherein the structural framework self-expands from the low-profile delivery configuration to the expanded deployed configuration upon emergence from a delivery catheter.

8. A prosthetic tricuspid valve and deployment system comprising:
a delivery catheter that defines a lumen therein, the delivery catheter configured for percutaneous use;
a prosthetic tricuspid valve, wherein the prosthetic tricuspid valve is reconfigurable between a low-profile delivery configuration for containment within the lumen and an expanded deployed configuration, wherein the prosthetic tricuspid valve comprises:
a structural framework of one or more braided nitinol wires arranged in a frustoconical shape that extends from a proximal end of the structural framework to a distal end of the structural framework, wherein the structural framework flares outward in a distal direction such that the proximal end of the structural framework is smaller than the distal end of the structural framework, the structural framework arranged to define an outer surface and an inner open region;
a cuff disposed on a proximal end portion of the outer surface, the cuff comprising a flexible covering material;
a plurality of anchor features, the anchor features extending outward from the outer surface, the anchor features configured for piercing tissue; and
a valve assembly disposed within the inner open region, the valve assembly comprising three leaflets that are configured for coaptation with each other; and

a control string, the control string being slidably engaged with the structural framework such that tensioning the control string can cause the structural framework to contract and slackening the control string can allow the structural framework to expand.

9. The prosthetic tricuspid valve and deployment system of claim 8 , wherein a distal end portion of the delivery catheter is selectively deflectable.

10. The prosthetic tricuspid valve and deployment system of claim 8 , wherein the structural framework has a linear outer wall profile between the proximal and distal ends of the structural framework.

11. The prosthetic tricuspid valve and deployment system of claim 10 , wherein the structural framework defines a non-circular transverse cross-sectional shape.

12. The prosthetic tricuspid valve and deployment system of claim 8 , wherein the flexible covering material comprises ePTFE or PTFE.

13. The prosthetic tricuspid valve and deployment system of claim 8 , wherein at least some of the anchor features extend outward from the outer surface at angles in a range from about 50° to about 90°.

14. The prosthetic tricuspid valve and deployment system of claim 8 , wherein at least some of the anchor features extend outward from the outer surface for distances in a range of about 0.6 mm to about 1.0 mm.

15. The prosthetic tricuspid valve and deployment system of claim 8 , wherein the structural framework self-expands from the low-profile delivery configuration to the expanded deployed configuration upon emergence from a delivery catheter.

16. A method of implanting a prosthetic tricuspid valve in a patient, the method comprising:
percutaneously installing a delivery catheter in the patient, wherein the delivery catheter defines a lumen therein, wherein the prosthetic tricuspid valve is disposed within the lumen in a low-profile delivery configuration, wherein the prosthetic tricuspid valve comprises:
a structural framework of one or more braided nitinol wires arranged in a frustoconical shape that extends from a proximal end of the structural framework to a distal end of the structural framework, wherein the structural framework flares outward in a distal direction such that the proximal end of the structural framework is smaller than the distal end of the structural framework, the structural framework arranged to define an outer surface and an inner open region;
a cuff disposed on a proximal end portion of the outer surface, the cuff comprising a flexible covering material;
a plurality of anchor features, the anchor features extending outward from the outer surface, the anchor features configured for piercing tissue; and
a valve assembly disposed within the inner open region, the valve assembly comprising three leaflets that are configured for coaptation with each other;

navigating the delivery catheter within the patient such that a distal end of the delivery catheter is position adjacent a native tricuspid valve of the patient; and
causing the prosthetic tricuspid valve to emerge from the lumen and to expand within the native tricuspid valve, wherein a majority of the prosthetic tricuspid valve is disposed below an annulus of the native tricuspid valve and within a right ventricle of the patient.

17. The method of claim 16 , wherein the causing the prosthetic tricuspid valve to emerge from the lumen and to expand within the native tricuspid valve also causes at least some of the anchor features to penetrate one or more native leaflets of the native tricuspid valve.

18. The method of claim 17 , wherein the prosthetic tricuspid valve further comprises a control string, the control string being slidably engaged with the structural framework such that tensioning the control string can cause the structural framework to contract and slackening the control string can allow the structural framework to expand.

19. The method of claim 18 , further comprising, after causing the prosthetic tricuspid valve to emerge from the lumen and to expand within the native tricuspid valve, tensioning the control string to contract the structural frame

Assignees

• Mayo Found Medical Education & Res

Inventors

• Pollak Peter M

Classifications

• A61F2/2412

  with soft flexible valve members, e.g. tissue valves shaped like natural valves · CPC title

• A61F2/2418 Primary

  Scaffolds therefor, e.g. support stents · CPC title

• A61F2210/0014

  using shape memory or superelastic materials, e.g. nitinol · CPC title

• A61F2230/0067

  conical · CPC title

• A61F2/2439

  Expansion controlled by filaments · CPC title