Transcatheter Prosthetic Heart Valve Delivery System With Recapturing Feature and Method

• US 20110245917A1
• Filed: 03/30/2010
• Published: 10/06/2011
• Est. Priority Date: 03/30/2010
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Savage, Padraig John, Pellegrini, Gianfranco Melino, Rinne, Finn Olavi, Rust, Matthew J.
• Granted Patent: US 9,320,597 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• 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, the system comprising:

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

a delivery sheath capsule slidably disposed over the inner shaft assembly and configured to compressively contain a 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.

2. The system of claim 1, 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.

3. 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.

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

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

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

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

8. 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.

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

10. 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 to a natural arrangement;

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.

11. The device of claim 10, 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.

12. The device of claim 10, wherein the frame is configured to provide columnar strength to the recapture assembly for sliding the recapture assembly over the prosthetic heart valve.

13. The device of claim 10, wherein the recapture frame includes a wire frame formed of a shape memory material.

14. The device of claim 10, wherein the sleeve is formed of a polymeric material.

15. The device of claim 10, wherein the recapture frame forms a support structure defining an internal surface and wherein the sleeve is attached to the internal surface.

16. The device of claim 10, wherein upon refraction of the delivery sheath capsule relative to the recapture assembly, the recapture frame transitions to the expanded arrangement.

17. A method of deploying a stented prosthetic heart valve to an implantation site, the method comprising:

receiving a delivery system loaded with a radially expandable prosthetic heart valve having a stent frame to which a valve structure is attached, the delivery system including a delivery sheath capsule containing the prosthetic heart valve in a compressed arrangement over an inner shaft assembly in a loaded state of the system, and a recapture assembly including a recapture frame and sleeve slidably disposed over the inner shaft assembly, the recapture assembly being longitudinally spaced from the prosthetic heart valve in the loaded state;

delivering the prosthetic heart valve in the compressed arrangement through a bodily lumen of the patient and to the implantation site via the delivery system in the loaded state;

proximally retracting the delivery sheath capsule relative to the prosthetic heart valve such that a distal region of the prosthetic heart valve is exposed distal the capsule, wherein the distal region self-expands toward a deployed arrangement;

evaluating a position of the prosthetic heart valve relative to the implantation site;

distally advancing the recapture assembly relative to the prosthetic heart valve such that the recapture assembly is distal the capsule and expands to an expanded arrangement having a distally increasing diameter;

distally advancing the frame over the prosthetic heart valve;

arranging the recapture assembly over the prosthetic heart valve to cause the distal region of the prosthetic heart valve to transition toward the collapsed arrangement within the recapture assembly; and

fully proximally retracting the recapture assembly from the prosthetic heart valve such that the prosthetic heart valve self-deploys from the inner shaft assembly.

18. The method of claim 17, 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.

19. The method of claim 17, wherein distally advancing the recapture assembly includes sliding the recapture assembly relative to the delivery sheath assembly.

20. The method of claim 19, wherein arranging the recapture sheath over the prosthetic heart valve to recapture the prosthetic heart valve includes sliding the frame and sleeve over the prosthetic heart valve.

21. The method of claim 17, wherein the recapture frame includes a wire frame formed of a shape memory material.

22. The method of claim 17, wherein the sleeve is formed of a polymeric material.

23. The method of claim 17, wherein the recapture frame forms a support structure defining an internal surface and wherein the sleeve is attached to the internal surface.

24. The method of claim 17, wherein upon retraction of the delivery sheath capsule relative to the recapture assembly, the recapture frame transitions to the expanded arrangement.