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

• US 9,931,204 B2
• Filed: 12/10/2015
• Issued: 04/03/2018
• 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:
  US14/964,777
• Publication Number:
  US 20170165058A1
• Time in Patent Office: 845 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 inflow member 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 inflow member and the locking mechanism is configured to permit the wire to be advanced within the channel to thereby transition the inflow member 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;

an inflow member attached to the plurality of commissure posts, the inflow member having an upstream portion and a downstream portion and a channel formed in a wall thereof, wherein the channel extends from at least the downstream portion to the upstream portion, and wherein an interior of the inflow member 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 inflow member, wherein the locking mechanism is configured to permit the wire to be advanced within the channel of the inflow member to thereby transition the inflow member into a deployed configuration.

2. The heart valve prosthesis of claim 1, wherein the inflow member is configured to inhibit paravalvular leakage between native anatomy of the heart and the heart valve prosthesis.

3. The heart valve prosthesis of claim 1, wherein the inflow member comprises a flexible sheet having opposing inner and outer layers that form the wall of the inflow member 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 inflow member at the upstream portion.

5. The heart valve prosthesis of claim 4, wherein the channel includes a longitudinal segment that extends from the circumferential segment to the downstream portion of the inflow member.

6. The heart valve prosthesis of claim 5, 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.

7. The heart valve prosthesis of claim 5, 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.

8. The heart valve prosthesis of claim 7, 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.

9. The heart valve prosthesis of claim 3, wherein a fold of the flexible sheet extends between the inner and outer layers, and the fold encircles the opening at the upstream portion of the inflow member to define at least a portion of the circumferential segment of the channel.

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

a housing with opposing pawls extending from a distal end thereof, and

a ratchet member slidably disposed within the housing, wherein the ratchet member has a plurality of circumferential indentations longitudinally spaced along a length thereof that individually interact with the opposing pawls of the housing to permit linear movement of the ratchet member relative to the housing in only a first direction.

11. The heart valve prosthesis of claim 10, wherein the wire is coupled to the ratchet member to be translatable therewith.

12. The heart valve prosthesis of claim 11, wherein a length of the wire extending within the channel of the inflow member may be incrementally increased by sequentially engaging the opposing pawls of the housing with each of the plurality of circumferential indentations as the ratchet member is moved in the first direction relative to the housing.

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

14. The heart valve prosthesis of claim 13, wherein the ratcheting mechanism further includes a ratchet tube slideably disposed between the ratchet member and the housing, and wherein the ratchet member is configured to be retracted relative to the housing when the ratchet tube is advanced to a position between the opposing pawls and the ratchet member such that the opposing pawls are disengaged from the circumferential indentations.

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

a prosthetic heart valve comprising

an anchoring structure;

an inflow member coupled to and extending from the anchoring structure, the inflow member defining a lumen from an inflow end to an outflow end thereof and having a channel within a wall thereof;

a prosthetic valve component disposed within the lumen of the inflow member, 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 inflow member to thereby transition the inflow member and the prosthetic valve component into a deployed configuration; and

a reversible ratcheting 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 reversible ratcheting mechanism to advance the stiffening element within the channel of the inflow member; and

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

16. The system of claim 15, wherein the reversible ratcheting mechanism comprises:

a ratchet housing secured to the anchoring structure, the ratchet housing having opposing first and second pawls extending from a distal end thereof; and

a ratchet member coupled to the stiffening element, the ratchet member slidably disposed within the ratchet housing, wherein the ratchet member has a plurality of circumferential indentations longitudinally spaced along a length thereof that individually interact with the first and second pawls of the ratchet housing to permit linear movement of the ratchet member relative to the ratchet housing in a first direction when engaged by the engagement tube upon actuation of the first actuator,

wherein a length of the stiffening element extending within the channel of the inflow member may be incrementally increased by sequentially engaging the opposing first and second pawls of the ratchet housing with each of the plurality of circumferential indentations as the ratchet member is moved in the first direction relative to the ratchet housing.

17. The system of claim 15, wherein the reversible ratcheting mechanism comprises:

a ratchet member coupled to the stiffening element;

a ratchet housing having opposing pawls extending from a distal end thereof and configured to incrementally engage the ratchet member; and

a ratchet tube slidably disposed between the ratchet member and the ratchet housing to inhibit engagement of the pawls with the ratchet member when in an advanced position.

18. The system of claim 17, wherein the handle assembly further comprises a second actuator operable for retracting the ratchet tube such that the pawls engage the ratchet member.

19. The system of claim 18, wherein the second actuator is configured to advance the ratchet tube to disengage the pawls from the ratchet member, and wherein the first actuator is configured to retract the ratchet member via the engagement tube to thereby transition the inflow member and the prosthetic valve component into a reduced-diameter configuration.

20. The system of claim 15, wherein the stiffening element is configured to be at least partially retracted from the channel of the inflow member to thereby transition the inflow member and the prosthetic valve component into a reduced-diameter configuration.

21. The system of claim 15, wherein the prosthetic heart valve further comprises a plurality of commissure posts extending from the anchoring structure, and wherein the inflow member comprises a sheet of flexible material coupled to the commissure posts.

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

23. The system of claim 15, wherein the stiffening element extends from the ratcheting mechanism through the channel to form a loop.

24. The system of claim 15, wherein a first end of the stiffening element is coupled to the ratcheting mechanism and a second end of the stiffening element is secured within the channel.

25. The system of claim 15, wherein the inflow member comprises a folded sheet of flexible material that forms opposing inner and outer layers of the wall of the inflow member between which the channel is defined.

26. The system of claim 25, wherein the channel includes a circumferential segment that at least partially surrounds an opening of the lumen at the inflow end of the inflow member.

27. A method of repairing or replacing a heart valve in a patient, the method comprising:

positioning a prosthetic device in a compressed configuration within a heart valve region of the patient;

releasing the prosthetic device to at least partially expand such that an inflow member extends through an annulus of the heart valve;

at least partially advancing a wire within a channel of the inflow member to transition the inflow member into a deployed configuration; and

locking a position of the wire when the inflow member is in the deployed configuration.

28. The method of claim 27, wherein at least partially advancing the wire comprises incrementally advancing the wire using a ratcheting mechanism.

29. The method of claim 27, wherein releasing the prosthetic device to at least partially expand includes retracting a delivery sheath from at least a distal portion of the prosthetic device.

30. The method of claim 27, further comprising:

releasing an anchoring structure of the prosthetic device to self-expand within a subannular region of the heart valve.