PERCUTANEOUSLY-DEPLOYABLE PROSTHETIC TRICUSPID VALVE

• US 20180289472A1
• Filed: 05/11/2016
• Published: 10/11/2018
• Est. Priority Date: 05/18/2015
• Status: Active Grant

• Current Assignee: Mayo Foundation For Medical Education And Research (Mayo Clinic)
• Original Assignee: Mayo Foundation For Medical Education And Research (Mayo Clinic)
• Inventors: Pollak, Peter M.
• Granted Patent: US 10,779,936 B2
• Time in Patent Office: Days
• 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 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2230/0067 conical

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.

Claims

1. A prosthetic tricuspid valve comprising:

a structural framework comprising one or more braided nitinol wires, 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 comprises a frustoconical shape.

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

4. 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°

.

5. 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.

6. 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.

7. The prosthetic tricuspid valve of claim 1, wherein the structural framework defines a non-circular transverse cross-sectional shape.

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 comprising one or more braided nitinol wires, 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 comprises a frustoconical shape.

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

12. 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°

.

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 for distances in a range of about 0.6 mm to about 1.0 mm.

14. 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.

15. The prosthetic tricuspid valve and deployment system of claim 8, wherein the structural framework defines a non-circular transverse cross-sectional shape.

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 comprising one or more braided nitinol wires, 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 framework such that the at least some of the anchor features that penetrated the one or more native leaflets are no longer penetrating the one or more native leaflets, and repositioning the prosthetic tricuspid valve within the native tricuspid valve.