Transcatheter prosthetic heart valve delivery system with recapturing feature and method

• US 9,320,597 B2
• Filed: 03/30/2010
• Issued: 04/26/2016
• Est. Priority Date: 03/30/2010
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Pellegrini, Gianfranco M., Rinne, Finn O., Rust, Matthew J., Savage, Padraig J.
• Primary Examiner(s): SHI, KATHERINE MENGLIN
• Application Number:
  US12/750,490
• Publication Number:
  US 20110245917A1
• Time in Patent Office: 2,219 Days
• Field of Search: 623/2.1, 623/2.11, 623/2.12, 623/1.11
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2002/9534 for repositioning of stents
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol

Abstract

A delivery system for percutaneously deploying a stented prosthetic heart valve. The system includes a delivery capsule and a recapture assembly. The capsule is configured to compressively retain the prosthesis. The recapture assembly includes a frame and sleeve attached to the frame. The recapture assembly is transitionable from a compressed arrangement to an expanded arrangement with a distally increasing diameter.

Claims

1. A delivery system for percutaneously deploying a stented prosthetic heart valve transitionable between a first arrangement defining a first diameter and a second arrangement defining a second diameter greater than the first diameter, the system comprising:

an inner shaft assembly including an intermediate portion providing a coupling structure configured to selectively engage the stented prosthetic heart valve;

a delivery sheath capsule slidably disposed over the inner shaft assembly and configured to compressively contain the stented prosthetic heart valve engaged with the coupling structure; and

a recapture assembly slidably disposed over the inner shaft assembly, the recapture assembly including a recapture frame and a sleeve coupled to the frame, wherein the frame is transitionable from a compressed arrangement to an expanded arrangement in which the frame has a distally increasing diameter;

wherein the system is configured to provide a loaded state in which the capsule compressively retains the stented prosthetic heart valve over the inner shaft assembly and the recapture assembly is longitudinally displaced from the stented prosthetic heart valve and wherein the system is further configured to provide a recapturing state in which a distal region of the stented prosthetic heart valve is distal the capsule and the recapture assembly is slidably disposed over the stented prosthetic heart valve distal the capsule in order to compress the stented prosthetic heart valve to a third arrangement, wherein a maximum diameter of the stented prosthetic heart valve in the third arrangement is greater than the first diameter and less than the second diameter.

2. The system of claim 1, wherein the delivery sheath capsule is provided as part of a delivery sheath assembly further including a delivery sheath shaft, and further wherein the recapture assembly is slidably disposed between the delivery sheath assembly and the inner shaft assembly.

3. The system of claim 1, wherein the frame is configured to provide columnar strength to the recapture assembly.

4. The system of claim 1, wherein the sleeve is attached to the frame using a stitch.

5. The system of claim 1, wherein the recapture frame includes a wire frame formed of a shape memory material.

6. The system of claim 1, wherein the sleeve is formed of a polymeric material.

7. The system of claim 1, wherein the recapture frame forms a support structure defining an internal surface and wherein the sleeve is attached to the internal surface.

8. The system of claim 1, wherein upon retraction of the delivery sheath capsule relative to the recapture assembly, the recapture frame transitions to the expanded arrangement.

9. A device for repairing a heart valve of a patient, the device comprising:

a delivery system including;

an inner shaft assembly including an intermediate portion providing a coupling structure,

a delivery sheath capsule slidably disposed over the inner shaft assembly,

a recapture assembly slidably disposed over the inner shaft assembly, the recapture assembly including a recapture frame and a sleeve attached to the recapture frame, wherein the frame is transitionable from a compressed arrangement to an expanded arrangement in which the frame has a distally increasing diameter; and

a prosthetic heart valve having a stent frame and a valve structure attached to the stent frame and forming at least two valve leaflets, the prosthetic heart valve being self-expandable from a compressed arrangement defining a first diameter to a natural arrangement defining a second diameter greater than the first diameter;

wherein the device is configured to be transitionable between;

a loaded state in which the prosthetic heart valve engages the coupling structure and is compressively retained within the capsule portion, the recapture assembly being longitudinally spaced from the prosthetic heart valve in the loaded state,

a partially deployed state in which the capsule is at least partially withdrawn from the prosthetic heart valve such that a distal region of the prosthetic heart valve is exposed relative to the capsule and self-expands, and

a recapturing state in which the recapture assembly is distal the capsule and positioned along the distal region of the prosthetic heart valve, causing the recapture frame to expand to the expanded arrangement and the prosthetic heart valve to compress to a recaptured arrangement defining a maximum diameter that is greater than the first diameter and less than the second diameter.

10. The device of claim 9, wherein the delivery sheath capsule is provided as part of a delivery sheath assembly further including a delivery sheath shaft, and further wherein the recapture assembly is slidably disposed between the delivery sheath assembly and the inner shaft assembly.

11. The device of claim 9, wherein the frame is configured to provide columnar strength to the recapture assembly for sliding the recapture assembly over the prosthetic heart valve.

12. The device of claim 9, wherein the recapture frame includes a wire frame formed of a shape memory material.

13. The device of claim 9, wherein the sleeve is formed of a polymeric material.

14. The device of claim 9, wherein the recapture frame forms a support structure defining an internal surface and wherein the sleeve is attached to the internal surface.

15. The device of claim 9, wherein upon retraction of the delivery sheath capsule relative to the recapture assembly, the recapture frame transitions to the expanded arrangement.