Transcatheter Prosthetic Heart Valve Delivery System With Funnel Recapturing Feature and Method

• US 20110251682A1
• Filed: 04/12/2010
• Published: 10/13/2011
• Est. Priority Date: 04/12/2010
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Savage, Padraig, Rust, Matthew, Murray, Robert III, Deshmukh, Susheel
• Granted Patent: US 8,512,401 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2002/9534 for repositioning of stents

Abstract

A delivery device for percutaneously deploying a stented prosthetic heart valve. The device includes a delivery capsule and a recapture sheath. The capsule is configured to compressively retain the prosthesis. The recapture sheath includes a funnel segment having a plurality of circumferentially spaced runners and a polymer overlay. The runners are attached to a shaft and terminate at a distal tip. The overlay surrounds the runners, and is bonded to the shaft but not to at least the tips. The funnel segment is transitionable from a normal condition to an expanded condition forming a funnel shape with a distally increasing diameter, and self-transitionable back toward the normal condition. The funnel segment facilitates sliding of the capsule over a partially deployed region of the prosthesis as part of a recapturing operation. The runners provide columnar strength, with the overlay controlling a shape of the funnel segment.

Claims

1. A delivery device for percutaneously deploying a stented prosthetic heart valve, the device 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; and

a recapture sheath slidably disposed over the inner shaft assembly, the recapture sheath including a funnel segment extending distally from a shaft, the funnel segment including;

a plurality of circumferentially spaced runners each attached at a first end to the shaft and terminating at a distal tip opposite the shaft,

a polymer overlay surrounding the runners, the overlay being bonded to the shaft and free of bonding to at least the distal tips,

wherein the funnel segment is transitionable from a normal condition to an expanded condition in which the funnel segment has a funnel shape with a distally increasing diameter, the funnel segment being self-transitionable from the expanded condition toward the normal condition;

wherein the system is configured to provide a delivery state in which the capsule compressively retains a stented prosthetic heart valve over the inner shaft assembly and the funnel segment is longitudinally displaced from the stented prosthetic heart valve.

2. The device of claim 1, wherein the device is further configured to provide a recapturing state in which the funnel segment is distal the capsule and the coupling structure, including the funnel segment forced to transition to the expanded condition.

3. The device 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 sheath is slidably disposed between the delivery sheath assembly and the inner shaft assembly.

4. The device of claim 1, wherein the recapture sheath shaft is formed as a distal extension from the capsule such that the capsule and the recapture sheath are slidably fixed to one another.

5. The device of claim 1, wherein the runners are thin strips of metal.

6. The device of claim 1, wherein the runners are configured to provide columnar strength to the funnel segment.

7. The device of claim 1, wherein the runners are configured to create a shape memory attribute in the funnel segment in which the normal condition is substantially cylindrical in shape.

8. The device of claim 7, wherein a diameter collectively defined by the distal tips in the normal condition is less than a diameter collectively defined by the distal tips in the expanded condition.

9. The device of claim 1, wherein the overlay is configured to control a shape collectively defined by the runners in transitioning from the normal condition to the expanded condition.

10. The device of claim 1, wherein the overlay is free of bonding to the runners distal the shaft such that the runners freely deflect within the overlay to the expanded condition in response to an internal expansive force.

11. The device of claim 1, wherein the overlay is a tube inverted into itself.

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

a delivery device 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 sheath slidably disposed over the inner shaft assembly, the recapture sheath including a funnel segment extending distally from a shaft, the funnel segment including;

a plurality of circumferentially spaced runners each attached at a first end to the shaft and terminating at a distal tip opposite the shaft,

a polymer overlay surrounding the runners, the overlay being bonded to the shaft and free of bonding to at least the distal tips,

wherein the funnel segment is transitionable from a normal condition to an expanded condition in which the funnel segment has a funnel shape with a distally increasing diameter, the funnel segment being self-transitionable from the expanded condition toward the normal condition; and

a prosthetic heart valve having a stent frame and a valve structure attached to the 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 system is configured to be transitionable between;

a loaded mode in which the prosthetic heart valve engages the coupling structure and is compressively retained within the capsule, the funnel segment being longitudinally spaced from the prosthetic heart valve in the loaded mode,

a partially deployed mode in which the capsule is 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,

a recapturing mode in which the funnel segment is distal the capsule and positioned along the distal region of the prosthetic heart valve, causing the funnel segment to expand to the expanded condition.

13. The system of claim 12, 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 sheath is slidably disposed between the delivery sheath assembly and the inner shaft assembly.

14. The system of claim 12, wherein the recapture sheath shaft is formed as a distal extension from the capsule such that the capsule and the recapture sheath are slidably fixed to one another.

15. The system of claim 12, wherein the runners are thin strips of metal.

16. The system of claim 12, wherein the runners are configured to provide columnar strength to the funnel segment for sliding the funnel segment over the prosthetic heart valve in response to a longitudinal force applied to the funnel segment.

17. The system of claim 12, wherein the runners are configured to create a shape memory attribute in the funnel segment in which the normal condition is substantially cylindrical in shape.

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

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

proximally retracting the capsule segment 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 sheath relative to the prosthetic heart valve such that the funnel segment is distal the capsule and expands to a funnel shape in response to contact with the distal region of the prosthetic heart valve;

distally advancing the funnel segment over the distal region of the prosthetic heart valve;

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

fully proximally retracting the capsule and the funnel segment from the prosthetic heart valve such that the prosthetic heart valve self-deploys from the inner shaft assembly.

19. The method of claim 18, 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 sheath is slidably disposed between the delivery sheath assembly and the inner shaft assembly.

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

21. The method of claim 20, wherein arranging the capsule over the prosthetic heart valve to recapture the prosthetic heart valve includes sliding the capsule over the funnel segment.

22. The method of claim 18, wherein the recapture sheath shaft is formed as a distal extension from the capsule such that the capsule and the recapture sheath are slidably fixed to one another.

23. The method of claim 22, wherein distally advancing the recapture sheath includes distally advancing the delivery sheath assembly.

24. The method of claim 23, wherein arranging the capsule over the prosthetic heart valve to recapture the prosthetic heart valve includes sliding the funnel segment distally beyond the prosthetic heart valve.