Transcatheter Delivery System and Method with Controlled Expansion and Contraction of Prosthetic Heart Valve

• US 20110301702A1
• Filed: 05/31/2011
• Published: 12/08/2011
• Est. Priority Date: 06/02/2010
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Rust, Matthew, Pellegrini, Gianfranco, Rinne, Finn, Padraig, Savage
• Granted Patent: US 9,561,102 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/008 paraboloidal

Abstract

A delivery system for use with a prosthetic heart valve having a stent frame to which a valve structure is attached, includes a shaft assembly including a distal end and a coupling structure disposed near the distal end and configured to be coupled to a distal end of the prosthetic heart valve. The system includes a sheath assembly defining a lumen sized to slidably receive the shaft assembly. The delivery system is configured to transition from a loaded state in which the sheath assembly encompasses the prosthetic heart valve to a deployed state in which the sheath assembly is withdrawn from the prosthetic heart valve. The coupling structure is configured to provide a controlled expansion or contraction of the distal end of the prosthetic heart valve based on longitudinal movement of the distal end of the shaft assembly.

Claims

1. A delivery system for use with a prosthetic heart valve having a stent frame to which a valve structure is attached, the system comprising:

a shaft assembly including a distal end and a coupling structure disposed near the distal end and configured to be coupled to a distal end of the prosthetic heart valve;

a sheath assembly defining a lumen sized to slidably receive the shaft assembly; and

wherein the delivery system is configured to transition from a loaded state in which the sheath assembly encompasses the prosthetic heart valve to a deployed state in which the sheath assembly is withdrawn from the prosthetic heart valve, and wherein the coupling structure is configured to provide a controlled expansion or contraction of the distal end of the prosthetic heart valve based on longitudinal movement of the distal end of the shaft assembly.

2. The delivery system of claim 1, wherein the coupling structure is configured to be moved in a first direction to provide a controlled expansion of the distal end of the prosthetic heart valve, and wherein the coupling structure is configured to be moved in a second direction opposite the first direction to provide a controlled contraction of the distal end of the prosthetic heart valve.

3. The delivery system of claim 2, wherein the first direction is a proximal direction and the second direction is a distal direction.

4. The delivery system of claim 1, wherein the shaft assembly further comprises a nose cone disposed at the distal end of the shaft assembly, and wherein the coupling structure is disposed at a proximal end of the nose cone.

5. The delivery system of claim 4, wherein the coupling structure is slidably attached to the nose cone, and wherein the coupling structure and the nose cone are configured to slide in a longitudinal direction with respect to each other.

6. The delivery system of claim 5, wherein the coupling structure includes a slot and the nose cone includes a feature configured to be positioned within the slot, wherein the slot and the feature are configured to guide the coupling structure as it slides with respect to the nose cone.

7. The delivery system of claim 5, wherein the nose cone is configured to be moved in a first direction to cause the coupling structure to provide a controlled expansion of the distal end of the prosthetic heart valve, and wherein the nose cone is configured to be moved in a second direction opposite the first direction to cause the coupling structure to provide a controlled contraction of the distal end of the prosthetic heart valve.

8. The delivery system of claim 7, wherein the first direction is a distal direction and the second direction is a proximal direction.

9. The delivery system of claim 1, wherein the coupling structure is configured to be automatically released from the distal end of the prosthetic heart valve when the prosthetic heart valve expands beyond a threshold amount.

10. The delivery system of claim 1, wherein the coupling structure is formed from a shape memory material.

11. The delivery system of claim 10, wherein the coupling structure is formed from Nitinol.

12. The delivery system of claim 1, wherein the coupling structure is formed from a polymer.

13. The delivery system of claim 1, wherein the coupling structure is formed from a suture material.

14. The delivery system of claim 1, wherein the coupling structure comprises a tubular base portion and a plurality of legs extending from the tubular base portion.

15. The delivery system of claim 14, wherein each of the legs includes a looped end portion that is configured to be releasably coupled to a hook on the distal end of the prosthetic heart valve.

16. The delivery system of claim 1, wherein the distal end of the prosthetic heart valve is an inflow end of the prosthetic heart valve.

17. The delivery system of claim 1, wherein the distal end of the prosthetic heart valve is an outflow end of the prosthetic heart valve.

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

a delivery system including;

a shaft assembly including a distal end and a coupling structure disposed near the distal end and configured to be coupled to a distal end of the prosthetic heart valve; and

a sheath assembly defining a lumen sized to slidably receive the shaft assembly;

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; and

wherein the delivery system is configured to slidably receive the prosthetic heart valve within the sheath assembly and is configured to be operable to transition from a loaded state in which the sheath assembly encompasses the prosthetic heart valve to a deployed state in which the sheath assembly is withdrawn from the prosthetic heart valve to permit the prosthetic heart valve to self-expand to the natural arrangement and release from the delivery system, and wherein the coupling structure is configured to provide a controlled expansion of the distal end of the prosthetic heart valve based on longitudinal movement of the distal end of the shaft assembly in a first direction, and provide a controlled contraction of the distal end of the prosthetic heart valve based on longitudinal movement of the distal end of the shaft assembly in a second direction opposite to the first direction.

19. The system of claim 18, wherein the first direction is a distal direction and the second direction is a proximal direction.

20. The system of claim 18, wherein the first direction is a proximal direction and the second direction is a distal direction.

21. The system of claim 18, wherein the shaft assembly further comprises a nose cone disposed at the distal end of the shaft assembly, and wherein the coupling structure is slidably attached to the nose cone.

22. The system of claim 18, wherein the coupling structure is configured to be automatically released from the distal end of the prosthetic heart valve when the prosthetic heart valve expands beyond a threshold amount.

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

receiving a delivery system loaded with a self-expanding prosthetic heart valve having a stent frame to which a valve structure is attached, the delivery system including a shaft assembly slidably positioned within a delivery sheath, the shaft assembly including a coupling structure disposed near a distal end of the shaft assembly and coupled to a distal end of the prosthetic heart valve, the delivery sheath containing the prosthetic heart valve in a compressed arrangement;

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

withdrawing the delivery sheath from the prosthetic heart valve;

moving the distal end of the shaft assembly in a first longitudinal direction to cause the coupling structure to provide a controlled expansion of the distal end of the prosthetic heart valve; and

releasing the prosthetic heart valve from the delivery system.

24. The method of claim 23, and further comprising:

evaluating a position of the prosthetic heart valve after providing the controlled expansion;

moving the distal end of the shaft assembly in a second longitudinal direction to cause the coupling structure to provide a controlled contraction of the prosthetic heart valve; and

manipulating the delivery system to reposition the prosthetic heart valve after providing the controlled contraction.