Systems, devices and methods for transcatheter valve delivery

• US 9,925,045 B2
• Filed: 10/21/2014
• Issued: 03/27/2018
• 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, Dwork, Joshua, Gallagher, John, Griffin, Patrick, Kenny, Gavin, McGowan Smyth, Deirdre, Milroy, John, Quill, Jason, Jamous, Herinaina Rabarimanantsoa, Rothstein, Paul, Sandstrom, Jeffrey, Sheahan, Edmond, White, Frank
• Primary Examiner(s): MCEVOY, THOMAS M
• Application Number:
  US14/519,242
• Publication Number:
  US 20150112430A1
• Time in Patent Office: 1,253 Days
• 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 In a partial deployment state, the outer sheath is at least partially withdrawn, allowing the stent frame to self-expand.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 Upon completion of the stent frame expansion, the tethers are withdrawn.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,

a hub assembly carried by the inner shaft, the hub assembly including a valve retainer configured to selectively receive a component of the stent frame, the valve retainer including a capture feature, the capture feature including a post circumscribed by a groove,

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 at least one of the proximal and distal sides connected to the delivery device via the first tether, the partial deployment state including expansion of at least one of the proximal and distal sides being controlled by a tension in the first tether,

wherein the delivery and partial deployment states include the first tether forming a loop and opposing, first and second tether segments extending from opposite sides of the loop, the loop located within the groove and about the post, and the first and second tether segments extending from the post and routed through first and second crowns of the stent frame,

a full deployment state in which the first tether is released from the stent frame.

2. The system of claim 1, wherein the first tether is connected to the proximal side 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 side 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 valve retainer is located proximate the distal tip.

11. The system of claim 1, wherein the valve retainer is located immediately proximate the proximal side of the prosthetic heart valve in the delivery state.

12. The system of claim 1, 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.

13. The system of claim 1, 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.

14. The system of claim 13, 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.

15. 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.

16. The system of claim 1, wherein at least a portion of each of the first and second tether segments extending through a lumen of the inner shaft.

17. The system of claim 1, wherein the delivery and partial deployment states include the first and second tether segments routed from the post to the first crown, from the first crown to the second crown, and from the second crown to the lumen.