STENTED TRANSCATHETER PROSTHETIC HEART VALVE DELIVERY SYSTEM AND METHOD

• US 20110098804A1
• Filed: 09/21/2010
• Published: 04/28/2011
• Est. Priority Date: 09/21/2009
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Shanahan, John, Allen, Jeffrey, Guo, Ya, Deshmukh, Susheel, Yeung, Hubert, Shipley, Adam, Udipi, Kishore, Dwork, Joshua
• Granted Patent: US 8,562,673 B2
• Time in Patent Office: Days
• US Class Current: 623/2.1
• 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 delivery device for percutaneously deploying a stented heart valve prosthesis, the device including:

an inner shaft assembly defining a distal tip, a proximal end, and an intermediate portion providing a coupling structure configured to selectively engage a stented heart valve prosthesis;

a sheath forming a lumen sized to slidably receive at least the intermediate portion of the shaft, the sheath terminating at a distal region; and

a tubular delivery capsule formed separately from the sheath, the capsule defining;

a proximal zone attached to the distal region of the sheath,

a distal zone terminating a distal end, wherein the distal zone is configured to transition between a normal state and a flared state, a diameter of the distal end being greater in the flared state than in the normal state,

wherein the capsule includes a shape memory component constructed to naturally assume the normal state;

wherein the device is configured to slidably receive a stented heart valve prosthesis within the delivery capsule and is operable to perform a reversible partial deployment procedure in which a portion of the stented heart valve prosthesis is exposed distal the capsule and radially expands, followed by distal advancement of the capsule relative to the stented heart valve prosthesis whereby the distal zone transitions to the flared state and imparts a collapsing force onto the stented heart valve prosthesis, causing the stented heart valve prosthesis to radially collapse.

2. The device of claim 1, wherein the capsule includes a laser cut tube.

3. The device of claim 2, wherein the capsule further includes a polymer encapsulating the laser cut tube.

4. The device of claim 2, wherein the laser cut tube is formed of Nitinol.

5. The device of claim 2, wherein the capsule further defines a first intermediate zone between the proximal and distal zones, the intermediate zone having an elevated radial flexibility as compared to at least the distal zone.

6. The device of claim 5, wherein the laser cut tube defines a plurality of generally longitudinally extending, interconnected primary splines forming a lattice structure along the distal zone, and a plurality of generally circumferentially extending, interconnected segments along the intermediate zone.

7. The device of claim 6, wherein the distal zone forms a base opposite the distal end and located distal the intermediate zone, and further wherein the primary splines of the distal zone extend from the base and pivot relative to the base in transitioning between the contracted and flared states.

8. The device of claim 7, wherein the laser cut tube further defines an undulating strut interconnecting circumferentially adjacent ones of the primary splines at the distal end.

9. The device of claim 6, wherein the laser cut tube further defines at least one longitudinal spine along the intermediate zone that interconnects longitudinally adjacent ones of the circumferential segments.

10. The device of claim 9, wherein the sheath includes a polymer tube maintaining at least one longitudinal sheath spine, and further wherein the at least one longitudinal spine of the tube is longitudinally aligned with at least one longitudinal delivery sheath spine.

11. The device of claim 9, wherein the intermediate zone includes two, circumferentially opposite longitudinal spines.

12. The device of claim 5, wherein the capsule further defines a second intermediate zone between the distal zone and the first intermediate zone, the second intermediate zone configured to transition between a collapsed state and an expanded state, a diameter of the second intermediate zone being greater in the expanded state than in the collapsed state.

13. The device of claim 12, wherein the shape memory component of the capsule is configured to naturally assume the collapsed state.

14. The device of claim 5, wherein the distal zone is formed by a first tube segment and the intermediate zone is formed by a second tube segment, and further wherein the first and second tube segments are separately formed and differ in terms of at least one attribute selected from the group consisting of material, wall thickness, and diameter.

15. 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 portion 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 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.

16. The method of claim 15, 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.

17. The method of claim 15, 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 a flared state toward a normal state.

18. The method of claim 15, 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.

19. A delivery device for percutaneously deploying a stented heart valve prosthesis, the device including:

an inner shaft assembly defining a distal tip, a proximal end, and an intermediate portion providing a coupling structure configured to selectively engage a stented heart valve prosthesis;

a sheath forming a lumen sized to slidably receive at least the intermediate portion of the shaft, the sheath terminating at a distal region; and

a delivery capsule formed separately from, and attached to, the distal region of the sheath, the delivery capsule including;

a tube cut to define a distal flarable zone and an intermediate flexible zone,

a polymer encasement encasing the tube, the polymer encasement including a thermoplastic polyether urethane blended with a silicone polymer.