Systems, Devices and Methods for Transcatheter Valve Delivery

• US 20150112430A1
• Filed: 10/21/2014
• Published: 04/23/2015
• Est. Priority Date: 10/21/2013
• Status: Active Grant

• Current Assignee: Medtronic Vascular Galway Limited (Medtronic Plc)
• Original Assignee: Medtronic Vascular Galway Limited (Medtronic Plc)
• Inventors: Creaven, Marian, Anderson, Marc, Corish, Kate, Costello, Declan, Duffy, Niall, Gallagher, John, Griffin, Patrick, Kenny, Gavin, McGowan Smyth, Deirdre, Milroy, John, Quill, Jason, Rothstein, Paul, Sandstrom, Jeffrey, Sheahan, Edmond, White, Frank, Dwork, Joshua, Jamous, Herinaina Rabarimanantsoa
• Granted Patent: US 9,925,045 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments

Abstract

A heart valve therapy system including a delivery device and a stented valve. The delivery device includes an outer sheath, an inner shaft, an optional hub assembly, and a plurality of tethers. In a delivery state, a stent frame of the prosthesis is crimped over the inner shaft and maintained in a compressed condition by the outer sheath. The tethers are connected to the stent frame. In a partial deployment state, the outer sheath is at least partially withdrawn, allowing the stent frame to self-expand. Tension in the tethers prevents the stent frame from rapidly expanding and optionally allowing recapture. Upon completion of the stent frame expansion, the tethers are withdrawn.

Claims

1. A system for performing a therapeutic procedure on a defective heart valve, the system comprising:

a prosthetic heart valve including a stent frame maintaining a valve structure, the stent frame configured to provide a compressed condition and a natural, expanded condition; and

a delivery device comprising;

a handle,

an inner shaft extending from the handle and terminating at a distal tip,

an outer sheath co-axially disposed over the inner shaft and including a capsule configured to contain the prosthetic heart valve,

a first tether defining a length between opposing, first and second ends;

wherein the system is configured to transition between;

a delivery state in which the prosthetic heart valve is maintained over the inner shaft in the compressed condition by the capsule and the first tether is connected to the stent frame, wherein the stent frame defines opposing proximal and distal sides relative to the delivery device,

a partial deployment state in which the capsule is withdrawn from the prosthetic heart valve and the first tether remains engaged with the stent frame and the stent frame expands toward the expanded condition with the proximal side connected to the delivery device via the first tether, the partial deployment state including expansion of the proximal side being controlled by a tension in the first tether,

a full deployment state in which the first tether is released from the stent frame to permit the first tether to be withdrawn from the stent frame.

2. The system of claim 1, wherein the first tether is connected to the proximal end of the stent frame in the delivery and partial deployment states.

3. The system of claim 1, wherein the first tether is connected to the distal end of the stent frame in the delivery and partial deployment states.

4. The system of claim 1, wherein the stent frame is a self-expanding stent frame configured to self-expand from the compressed condition to the normal, expanded condition.

5. The system of claim 1, wherein the stent frame is a balloon-expandable stent frame.

6. The system of claim 1, wherein the system is further configured to provide a recapture operation in the partial deployment state in which a tension in the first tether is increased and causes a corresponding region of the stent frame to partially re-collapse.

7. The system of claim 1, wherein the first tether is looped through a component of the stent frame in the delivery and partial deployment states.

8. The system of claim 1, wherein the system is configured such that the first tether self-releases from the stent frame in the partial deployment state such that the partial deployment state includes a tension in the tether allowing slow release of the stent frame.

9. The system of claim 8, wherein the first tether is wound about a component of the stent frame in the delivery state.

10. The system of claim 1, wherein the delivery device further includes a biasing member disposed between the stent frame and an end of the first tether, and further wherein the partial deployment state includes a deployment force of the stent frame gradually overcoming a biasing force of the biasing member.

11. The system of claim 1, wherein the delivery device further includes a hub assembly carried by the inner shaft.

12. The system of claim 11, wherein the hub assembly includes a valve retainer configured to selectively receive a component of the stent frame in at least the delivery state, and further wherein the first tether is coupled to a capture feature of the valve retainer in the delivery and partial deployment states.

13. The system of claim 12, wherein the valve retainer is located proximate the distal tip.

14. The system of claim 12, wherein the valve retainer is located immediately proximate the proximal end of the prosthetic heart valve in the delivery state.

15. The system of claim 12, wherein the prosthetic heart valve defines a length in the compressed condition, and further wherein a longitudinal distance between the valve retainer and the distal tip approximates the length of the prosthetic heart valve.

16. The system of claim 12, wherein the first tether is one of a plurality of tethers provided with the delivery device, each of the plurality of tethers being connected to the proximal side of the prosthetic heart valve in the delivery and partial deployment states.

17. The system of claim 16, wherein the valve retainer defines a plurality of capture features, and further wherein each of the capture features is configured to selectively engage a corresponding one of the plurality of tethers.

18. The system of claim 12, wherein the system is configured such that partial deployment state includes a distal end of the capsule being located distal the capture feature of the valve retainer such that the capsule retains engagement between the first tether and the valve retainer.

19. The system of claim 12, wherein the capture feature includes a post circumscribed by a groove, the first tether being located within the groove and looped about the post in the delivery and partial deployment states.

20. A method of performing a therapeutic procedure on a defective heart valve of a patient, the method comprising:

receiving a system in a delivery state, the system including a prosthetic heart valve loaded to a delivery device, the prosthetic heart valve including a stent frame maintaining a valve structure, the stent frame defining proximal and distal side, the delivery device including a handle, an inner shaft, an outer sheath forming a capsule, and a first tether, wherein the delivery state includes;

the prosthetic heart valve maintained over the inner shaft by the capsule in a compressed condition, and

the first tether connected to the stent frame;

manipulating the delivery device to guide the prosthetic heart valve through the patient'"'"'s vasculature and into the defective heart valve;

transitioning the system to a partial deployment state by proximally retracting the capsule from the prosthetic heart valve, the partial deployment state including the prosthetic heart valve expanding from the compressed condition toward a natural, expanded condition and remaining connected to the delivery device via the first tether;

altering a tension in the first tether to allow a corresponding region of the stent frame to slowly expand toward the expanded condition; and

transitioning the system to a full deployment state, including removing the first tether from the stent frame.

21. The method of claim 20, further comprising:

prior to the step of transitioning the system to a full deployment state, increasing a tension in the first tether to partially re-collapse a corresponding region of the stent frame.

22. The method of claim 20, wherein the stent frame is a self-expanding stent frame configured to self-expand from the compressed condition to the natural condition.

23. The method of claim 20, wherein the first tether is connected to the proximal end of the stent frame in the delivery and partial deployment states.

24. The method of claim 20, wherein the first tether is connected to the distal end of the stent frame in the delivery and partial deployment states.

25. The method of claim 20, wherein the first tether is looped through a segment of the stent frame in the delivery and partial deployment states.

26. The method of claim 20, wherein the system is configured such that the first tether self-releases from the stent frame as part of the step of transitioning the system to a partial deployment state.

27. The method of claim 20, wherein the delivery device includes a plurality of tethers, including the first tether, and further wherein delivery state includes each of the plurality of tethers connected to the stent frame.

28. The method of claim 27, wherein the step of altering a tension in the first tether includes simultaneously altering a tension in each of the plurality of tethers.

29. The method of claim 20, wherein the delivery device further includes a valve retainer carried by the inner shaft, the valve retainer configured to selectively receive a component of the stent frame and forming a capture feature configured to selectively maintain a portion of the first tether in the delivery and partial deployment states.

30. The method of claim 29, wherein the step of transitioning the system to the partial deployment state includes locating a distal end of the capsule longitudinally between the prosthetic heart valve and the valve retainer.

31. The method of claim 30, wherein the step of transitioning the system to the full deployment state includes locating the distal end of the capsule proximal the capture feature of the valve retainer.

32. The method of claim 31, wherein the step of transitioning the system to the full deployment state includes the first tether self-releasing from the valve retainer body upon retraction of the distal end of the capsule proximal the capture feature of the valve retainer.