Stented transcatheter prosthetic heart valve delivery system and method

• US 8,974,524 B2
• Filed: 10/17/2013
• Issued: 03/10/2015
• Est. Priority Date: 09/21/2009
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Yeung, Hubert, Shanahan, John, Dwork, Joshua, Shipley, Adam, Allen, Jeffrey, Deshmukh, Susheel, Udipi, Kishore, Guo, Ya
• Primary Examiner(s): Houston, Elizabeth
• Assistant Examiner(s): LYNCH, ROBERT A
• Application Number:
  US14/056,467
• Publication Number:
  US 20140046435A1
• Time in Patent Office: 509 Days
• Field of Search: 623/1.11, 623/1.12, 623/1.23, 623/2.11, 623/2.17, 623/2.18, 623/904, 606/108, 606/151, 606153-156, 606/191, 606/198, 606/200
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• 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 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/9528 for retrieval of stents
• CPC Class Codes: A61F 2002/9534 for repositioning of stents
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/008 paraboloidal

Abstract

A percutaneous stented valve delivery device including an inner shaft, a sheath, and a delivery capsule. The sheath slidably receives the inner shaft. A capsule proximal zone is attached to the sheath. A capsule distal zone is configured to transition between normal and flared states. A diameter of the distal zone is greater in the flared state, and the capsule includes a shape memory component that naturally assumes the normal state. The device is operable to perform a reversible partial deployment procedure in which a portion of the prosthesis is exposed distal the capsule and allowed to radially expand. Subsequently, with distal advancement of the capsule, the distal zone transitions to the flared state and imparts a collapsing force onto the prosthesis, causing the prosthesis to radially collapse and become recaptured within the delivery capsule. The capsule can include a laser cut tube encapsulated by a polymer.

Claims

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

removably loading a stented heart valve prosthesis to a delivery device, the delivery device including;

an inner shaft,

a sheath forming a lumen and a distal region,

a tubular delivery capsule having a proximal zone attached to and extending from the distal region and a distal zone opposite the proximal zone,

wherein the stented heart valve prosthesis is coupled to the inner shaft and is slidably received within the delivery capsule such that the delivery device retains the stented heart valve prosthesis in a collapsed arrangement;

delivering the stented heart valve prosthesis in the collapsed arrangement through a bodily lumen and to the implantation site via the delivery device;

partially proximally retracting the delivery capsule relative to the stented heart valve prosthesis such that a distal portion of the stented heart valve prosthesis is exposed distal the capsule, wherein the distal zone of the tubular delivery capsule maintains a normal non-flared state during the step of partial proximal retraction of the delivery capsule, and wherein the exposed distal portion of the stented heart valve prosthesis self-expands toward an expanded arrangement and at least a proximal portion of the stented heart valve prosthesis is retained within at least the delivery capsule in the collapsed arrangement;

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

distally advancing the sheath and the capsule relative to the stented heart valve prosthesis when the evaluation indicates that the stented heart valve prosthesis is not correctly positioned, wherein the distal zone circumferentially flares to a flared state about the stented heart valve prosthesis with the distal movement while simultaneously imparting a collapsing force onto a contacted region of the stented heart valve prosthesis, causing the contacted region to transition toward the collapsed arrangement; and

fully proximally retracting the delivery capsule from the stented heart valve prosthesis such that the stented heart valve prosthesis deploys from the inner shaft.

2. The method of claim 1, wherein:

the step of partially retracting the delivery capsule relative to the stented prosthetic heart valve includes operating an actuator of the delivery device in a first direction; and

the step of distally advancing the sheath and the delivery capsule includes operating the actuator in a second direction opposite the first direction.

3. The method of claim 1, wherein the step of distally advancing the sheath and the delivery capsule includes locating the distal zone distal the prosthetic heart valve, and further wherein the distal zone self-transitions from the flared state toward the normal state.

4. The method of claim 1, wherein following the step of distally advancing the sheath and the delivery capsule, the method further comprising repositioning the delivery capsule relative to the implantation site with the distal zone in the normal state.