Transcatheter prosthetic heart valve delivery system with funnel recapturing feature and method

• US 8,986,372 B2
• Filed: 08/19/2013
• Issued: 03/24/2015
• Est. Priority Date: 04/12/2010
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Murry, Robert III, Deshmukh, Susheel, Rust, Matthew, Savage, Padraig
• Primary Examiner(s): SHI, KATHERINE MENGLIN
• Application Number:
  US13/969,784
• Publication Number:
  US 20140012369A1
• Time in Patent Office: 582 Days
• Field of Search: 623/1.11, 623/2.1, 623/2.11, 623/2.12, 606/108, 606/191, 606/194, 606/198, 606/200
• 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 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.

2. The method 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.

3. The method of claim 2, wherein distally advancing the recapture sheath includes sliding the recapture sheath relative to the delivery sheath assembly.

4. The method of claim 3, wherein arranging the capsule over the prosthetic heart valve to recapture the prosthetic heart valve includes sliding the capsule over the funnel segment.

5. The method 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.

6. The method of claim 5, wherein distally advancing the recapture sheath includes distally advancing the delivery sheath assembly.

7. The method of claim 6, 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.