Transcatheter heart valve replacement systems, heart valve prostheses, and methods for percutaneous heart valve replacement

• US 10,695,172 B2
• Filed: 03/27/2018
• Issued: 06/30/2020
• Est. Priority Date: 12/10/2015
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Rothstein, Paul, Sandstrom, Jeffrey
• Primary Examiner(s): Woo, Julian W
• Application Number:
  US15/936,901
• Publication Number:
  US 20180214264A1
• Time in Patent Office: 826 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2250/0004 adjustable
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

A transcatheter heart valve prosthesis configured in accordance herewith includes an expandable frame having a plurality of commissure posts extending therefrom, a radially expandable tubular component attached to the plurality of commissure posts, and a locking mechanism operably coupled to a wire. The wire is at least partially slideably disposed within a channel formed in a wall of the tubular component and the locking mechanism is configured to permit the wire to be advanced within the channel to thereby transition the tubular component into a deployed configuration that at least partially engages tissue at the native heart valve.

Claims

1. A heart valve prosthesis for implantation at a native valve region of a heart, the prosthesis comprising:

an expandable frame defining a lumen through which blood may flow, the lumen extending from a first end to a second end thereof, wherein the frame includes a plurality of commissure posts extending from the first end;

a tubular component attached to the plurality of commissure posts, the tubular component having a first portion and a second portion and a channel formed in a wall thereof, wherein an interior of the tubular component is configured to support a prosthetic valve;

a locking mechanism secured within the lumen of the expandable frame; and

a wire operably coupled to the locking mechanism, the wire being at least partially slideably disposed within the channel of the tubular component, wherein the locking mechanism is configured to permit the wire to be advanced within the channel of the tubular component to thereby transition the tubular component into a deployed configuration.

2. The heart valve prosthesis of claim 1, wherein the channel extends from at least the second portion to the first portion.

3. The heart valve prosthesis of claim 1, wherein the tubular component comprises a flexible sheet having opposed inner and outer layers that form the wall of the tubular component and between which the channel is defined.

4. The heart valve prosthesis of claim 3, wherein the channel includes a circumferential segment that at least partially surrounds an opening of the tubular component at the first portion.

5. The heart valve prosthesis of claim 4, wherein a fold of the flexible sheet extends between the inner and outer layers, and the fold encircles the opening at the first portion of the tubular component to define at least a portion of the circumferential segment of the channel.

6. The heart valve prosthesis of claim 4, wherein the channel includes a longitudinal segment that extends from the circumferential segment to the second portion of the tubular component.

7. The heart valve prosthesis of claim 6, wherein the wire extends from the locking mechanism through the longitudinal segment and at least partially through the circumferential segment of the channel, and wherein a first end of the wire is coupled to the locking mechanism and a second end of the wire is secured within the circumferential segment.

8. The heart valve prosthesis of claim 6, wherein the wire has first and second wire ends coupled to the locking mechanism, and wherein a portion of the wire between the first and second ends is slidably disposed within the longitudinal and circumferential segments to form a loop.

9. The heart valve prosthesis of claim 8, wherein a radius of the loop is configured to increase or decrease by advancing or retracting at least one of the first or second wire ends.

10. The heart valve prosthesis of claim 1, wherein the locking mechanism is a ratcheting mechanism.

11. The heart valve prosthesis of claim 10, wherein the ratcheting mechanism is configured to permit a ratchet member to be retracted relative to a housing in order to at least partially retract the wire from the channel of the tubular component to thereby transition the tubular component into a reduced-diameter configuration.

12. A system for repair or replacement of a heart valve, the system comprising:

a prosthetic heart valve comprising,

an anchoring structure,

a tubular component coupled to and extending from the anchoring structure, the tubular component defining a lumen and having a channel within a wall thereof,

a prosthetic valve component disposed within the lumen of the tubular component, the prosthetic valve component configured to inhibit retrograde blood flow through the lumen,

an elongated stiffening element at least partially disposed within the channel of the tubular component to thereby transition the tubular component and the prosthetic valve component into a deployed configuration, and

a locking mechanism secured to the anchoring structure and coupled to the stiffening element; and

a catheter assembly configured to deliver and deploy the prosthetic heart valve, the catheter assembly comprising,

a handle assembly having a first actuator for operating the locking mechanism to advance the stiffening element within the channel of the tubular component, and

an engagement tube extending from the handle assembly, the engagement tube configured to operatively engage the locking mechanism at a proximal end thereof upon actuation of the first actuator.

13. The system of claim 12, wherein the stiffening element is configured to be at least partially retracted from the channel of the tubular component to thereby transition the tubular component and the prosthetic valve component into a reduced-diameter configuration.

14. The system of claim 12, wherein the prosthetic heart valve further comprises a plurality of commissure posts extending from the anchoring structure, and wherein the tubular component comprises a sheet of flexible material coupled to the commissure posts.

15. The system of claim 12, wherein the stiffening element at least partially disposed within the channel of the tubular component is structurally independent of the anchoring structure, and wherein the stiffening element is radially deformable without substantially deforming the anchoring structure.

16. The system of claim 12, wherein the stiffening element extends from the locking mechanism through the channel to form a loop.

17. The system of claim 12, wherein a first end of the stiffening element is coupled to the locking mechanism and a second end of the stiffening element is secured within the channel.

18. The system of claim 12, wherein the tubular component comprises a folded sheet of flexible material that forms opposed inner and outer layers of the wall of the tubular component between which the channel is defined.

19. The system of claim 18, wherein the channel includes a circumferential segment that at least partially surrounds an opening of the lumen of the tubular component.

20. The system of claim 12, wherein the locking mechanism is a ratcheting mechanism.