Transcatheter delivery system and method with controlled expansion and contraction of prosthetic heart valve

Patent metadata

Field	Value
Publication number	US-12496191-B2
Application number	US-202318385338-A
Country	US
Kind code	B2
Filing date	Oct 30, 2023
Priority date	Jun 2, 2010
Publication date	Dec 16, 2025
Grant date	Dec 16, 2025

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in which the sheath assembly encompasses the prosthetic heart valve to a deployed state in which the sheath assembly is withdrawn from the prosthetic heart valve.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.

First claim

What is claimed is:

1 . 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 comprising 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 to release the prosthetic heart valve, wherein the prosthetic heart valve is permitted to radially self-expand towards an expanded arrangement; 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 by inhibiting a radial expansion of the prosthetic heart valve towards the expanded arrangement; and releasing the prosthetic heart valve from the delivery system.

2 . The method of claim 1 , wherein withdrawing the delivery sheath only comprises partially withdrawing the delivery sheath from the prosthetic heart valve prior to the coupling structure providing the controlled expansion of the distal end of the prosthetic heart valve.

3 . The method of claim 1 , wherein, prior to releasing the prosthetic heart valve from the delivery system, further comprising:
evaluating a position of the prosthetic heart valve after providing the controlled expansion; then 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 then manipulating the delivery system to reposition the prosthetic heart valve after providing the controlled contraction.

4 . The method of claim 3 , wherein after manipulating the delivery system to reposition the prosthetic heart valve and prior to releasing the prosthetic heart valve from the delivery system, further comprising withdrawing the delivery sheath from the prosthetic heart valve for a second time, and moving the distal end of the shaft assembly in the first longitudinal direction to cause the coupling structure to provide a second controlled expansion of the distal end of the prosthetic heart valve.

5 . The method of claim 4 , wherein withdrawing the delivery sheath from the prosthetic heart valve for the second time only comprises partially withdrawing the delivery sheath from the prosthetic heart valve prior to the coupling structure providing the second controlled expansion of the distal end of the prosthetic heart valve.

6 . The method of claim 1 , wherein the first longitudinal direction is a proximal direction.

7 . The method of claim 1 , wherein the coupling structure comprises a shape memory material.

8 . The method of claim 7 , wherein the shape memory material comprises Nitinol.

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

10 . The method of claim 1 , wherein the shaft assembly further comprises a nose cone and the coupling structure comprises a tubular base portion attached to a proximal end portion of the nose cone and a plurality of legs releasably coupled to the distal end of the prosthetic heart valve, wherein moving the distal end of the shaft assembly in the first longitudinal direction causes the coupling structure and the nose cone to move together in the first longitudinal direction to provide the controlled expansion of the distal end of the prosthetic heart valve.

11 . The method of claim 1 , wherein the shaft assembly further comprises a nose cone and the coupling structure comprises a tubular base portion slidably connected to a proximal end portion of the nose cone, and the coupling structure comprises a plurality of legs releasably coupled to the distal end of the prosthetic heart valve, wherein moving the distal end of the shaft assembly in the first longitudinal direction causes the nose cone to slide relative to the coupling structure in the first longitudinal direction to provide the controlled expansion of the distal end of the prosthetic heart valve.

12 . The method of claim 11 , wherein sliding the nose cone relative to the coupling structure in the first longitudinal direction results in the plurality of legs of the coupling structure extending out of a lumen of the proximal end portion of the nose cone to provide the controlled expansion of the distal end of the prosthetic heart valve.

13 . A method of recapturing a partially deployed self-expanding prosthetic heart valve comprising:
receiving a delivery system loaded with the 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 partially containing the prosthetic heart valve in a compressed arrangement with a distal portion of the prosthetic heart valve extending outside of a distal end of the delivery sheath with the coupling structure controlling the expansion of the distal end of the prosthetic heart valve; 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 distal end of the prosthetic heart valve by opposing a radial expansion of the prosthetic heart valve towards an expanded arrangement; and moving the delivery sheath to fully contain the prosthetic heart valve in a compressed arrangement.

14 . The method of claim 13 , wherein the second longitudinal direction is a distal direction.

15 . The method of claim 13 , wherein the coupling structure comprises a shape memory material.

16 . The method of claim 15 , wherein the shape memory material comprises Nitinol.

17 . The method of claim 13 , wherein the shaft assembly further comprises a nose cone and the coupling structure comprises a tubular base portion attached to a proximal end portion of the nose cone and a plurality of legs releasably coupled to the distal end of the prosthetic heart valve, wherein moving the distal end of the shaft assembly in the second longitudinal direction causes the coupling structure and the nose cone to move together in the second longitudinal direction to provide the controlled contraction of the distal end of the prosthetic heart valve.

18 . The method of claim 13 , wherein the shaft assembly further comprises a nose cone and the coupling structure comprises a tubular base portion slidably connected to a proximal end portion of the nose cone, and the coupling structure comprises a plurality of legs releasably coupled to the distal end of the prosthetic heart valve, wherein moving the distal end of the shaft assembly in the second longitudinal direction causes the nose cone to slide relative to the coupling structure in the second longitudinal direction to provide the controlled contraction of the distal end of

Assignees

• Medtronic Inc

Inventors

• Rust Matthew
• Savage Padraig
• Pellegrini Gianfranco
• Rinne Finn

Classifications

• A61F2230/008

  paraboloidal · CPC title

• A61F2230/0054

  V-shaped · CPC title

• A61F2230/005

  Rosette-shaped, e.g. star-shaped · CPC title

• A61F2002/9665

  with additional retaining means · CPC title

• A61F2/2418

  Scaffolds therefor, e.g. support stents · CPC title