Transcatheter Prosthetic Heart Valve Delivery Device With Passive Trigger Release

• US 20110264203A1
• Filed: 04/27/2011
• Published: 10/27/2011
• Est. Priority Date: 04/27/2010
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Stante, Glenn, Dwork, Joshua, Shipley, Adam
• Granted Patent: US 8,876,893 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 2/2436 Deployment by retracting a sheath
• 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 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/008 paraboloidal

Abstract

A delivery device for percutaneously deploying a prosthetic valve includes a sheath, an inner shaft, and a release assembly. The release assembly is disposed between the sheath and the inner shaft, and includes a retraction member, a release member, and a retention member. The retraction member can self-retract in length from an extended condition to a retracted condition. The release member can self-expand from a compressed condition to an expanded condition. The retention member is distal the release member. In a delivery state, the sheath end is distal the retention member, the release member is in the compressed condition and the retraction member in the extended condition to retain the prosthesis. In a deployment state, the sheath end is positioned to permit the release member to self-transition to the expanded condition, allowing the retraction member to self-transition to the retracted condition and release the prosthesis.

Claims

1. A delivery device for percutaneously deploying a stented prosthetic heart valve including a stent frame to which a valve structure is attached, the device comprising:

a delivery sheath terminating at a distal end and defining a lumen;

an inner shaft assembly slidably disposed within the lumen and including an engagement structure configured to selectively engage a prosthetic heart valve; and

a release assembly disposed between the delivery sheath and the inner shaft assembly, the release assembly defining a central axis and including;

a base coupled to the inner shaft assembly proximal the engagement structure,

a retraction member distal the base and configured to self-retract in longitudinal length from an extended condition to a relaxed, retracted condition,

a release member distal the retraction member and configured to self-expand in radial projection relative to the central axis from a compressed condition to a normal, expanded condition,

a retention member distal the release member;

wherein the device is configured to provide;

a delivery state in which the distal end is distal the retention member, the release member is in the compressed condition, and the retraction member is in the extended condition,

a deployment state in which the distal end is proximal the release member, the release member is in the normal, expanded condition, and the retraction member is in the relaxed, retracted condition.

2. The delivery device of claim 1, wherein the engagement structure includes a spindle forming a plurality of longitudinal capture slots and a circumferential trough.

3. The delivery device of claim 2, wherein the delivery state includes the retention member being disposed over the circumferential trough.

4. The delivery device of claim 2, wherein the deployment state includes the retention member located proximal the circumferential trough.

5. The delivery device of claim 1, wherein a longitudinal distance between the base and the retention member in the extended condition of the retraction member is less than a longitudinal distance between the base and the retention member in the relaxed, retracted condition.

6. The delivery device of claim 1, wherein the retention member is a linear spring.

7. The delivery device of claim 6, wherein the linear spring is formed by a laser cut metal tube.

8. The delivery device of claim 1, wherein the release member is a deflection arm having a fixed end, a free end, and an intermediate portion having a memory set angled shape.

9. The delivery device of claim 8, wherein the fixed end is spatially affixed to the retraction member and the free end is radially deflectable relative to the central axis, with the arm pivoting at the fixed end.

10. The delivery device of claim 9, wherein the release assembly further includes a connection body interconnecting a distal side of the retraction member with a proximal side of the retention member, the connection body forming a clearance slot sized and positioned to permit passage of the free end in transitioning from the expanded condition to the compressed condition.

11. The delivery device of claim 10, wherein the compressed condition includes the free end projecting through the clearance slot.

12. The delivery device of claim 11, wherein the inner shaft assembly further includes a tubular base forming a primary notch proximal the engagement structure, and further wherein the delivery state includes the free end nested within the primary notch.

13. The delivery device of claim 12, wherein the tubular base further forms a secondary notch proximal the primary notch, and further wherein the delivery device is configured to provide a removal state in which the distal end of the delivery sheath is distal the release member, the retention member is in the relaxed, retracted condition, and the deflection arm is in the compressed condition including the free end nested within the secondary notch.

14. The delivery device of claim 8, wherein the release member deflection arm is a first release member deflection arm, and further wherein the release assembly further includes a second release member deflection arm circumferentially opposite the first release member deflection arm.

15. The delivery device of claim 1, wherein the release member defines a maximum radial projection relative to the central axis in the normal, expanded condition, and further wherein the maximum radial projection is greater than a radius of the delivery sheath lumen.

16. A system for restoring a defective heart valve of a patient, the system comprising:

a prosthetic heart valve having a stent frame and a valve structure attached to the stent frame, the stent frame defining a distal region and a proximal region, the proximal region forming at least one post; and

a delivery device comprising;

a delivery sheath terminating at a distal end and defining a lumen,

an inner shaft assembly slidably disposed within the lumen and including an engagement structure,

a release assembly for selectively coupling the prosthetic heart valve relative to the inner shaft assembly, the release assembly defining a central axis and including;

a base coupled to the inner shaft assembly proximal the engagement structure,

a retraction member distal the base and configured to self-retract in longitudinal length from an extended condition to a relaxed, retracted condition,

a release member distal the retraction member and configured to self-expand in radial projection relative to the central axis from a compressed condition to a normal, expanded condition,

a retention member distal the release member;

wherein the system is configured to provide a loaded mode in which the prosthetic heart valve is retained within the delivery sheath and to the inner shaft assembly, including the at least one post slidably captured to the engagement structure by the retention member, with the retraction member in the extended condition and the release member in the compressed condition.

17. The system of claim 16, wherein the system is further configured to provide a deployment mode in which the distal end is proximal the release member, the release member is in the normal, expanded condition, and the retraction member is in the relaxed, retracted condition to withdraw the retention member from over the post and permit the prosthetic heart valve to self-deploy from the delivery device.

18. The system of claim 16, wherein the engagement structure includes a spindle forming a plurality of longitudinal capture slots and a circumferential trough, and further wherein the loaded mode includes the post slidably disposed within one of the capture slots and the trough, the retention member extending distal the trough.

19. The system of claim 16, wherein the retention member is a linear spring.

20. The system of claim 16, wherein the release member is a deflection arm having a fixed end, a free end, and an intermediate portion having a memory set angled shape.

21. The system of claim 20, wherein the fixed end is spatially affixed to the retraction member and the free end is radially deflectable relative to the central axis, pivoting at the fixed end.

22. The system of claim 21, wherein the release assembly further includes a connection body interconnecting a distal side of the retraction member with a proximal side of the retention member, the connection body forming a clearance slot sized and positioned to permit passage of the free end.

23. The system of claim 22, wherein the compressed condition includes the free end projecting through the clearance slot.

24. The system of claim 23, wherein the inner shaft assembly further includes a tubular base forming a primary notch proximal the engagement structure, and further wherein the delivery state includes the free end nested within the primary notch.

25. The system of claim 16, wherein the delivery mode includes the delivery sheath forcing the release member to the compressed condition.

26. The system of claim 16, wherein the delivery device is further transitionable from the deployment mode to a removal state following deployment of the prosthetic heart valve, the removal state including the distal end of the delivery sheath being distal the release member to force the release member to the compressed condition and the retraction member in the relaxed, retracted condition.

27. A method for percutaneously deploying a stented prosthetic heart valve to an implantation site of a patient, 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, an inner shaft assembly, and a release assembly, the delivery sheath and the release assembly containing the prosthetic heart valve in a compressed arrangement over the inner shaft assembly in a delivery state of the delivery device, and the release assembly including;

a base coupled to the inner shaft assembly,

a retraction member extending distal the base and forced to an extended condition,

a release member distal the retraction member and forced to a compressed arrangement in which the release member engages the inner shaft assembly,

a retention member distal the release member and disposed over a portion of the prosthetic heart valve;

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 delivery sheath from the prosthetic heart valve and the release member; and

permitting the prosthetic heart valve to release from the delivery device including the release member self-transitioning to a normal, expanded condition and the retention member self-retracting to a normal, retracted condition to proximally withdraw the retention member from over the prosthetic heart valve.

28. The method of claim 27, wherein the retraction member is a linear spring and the retention member is a deflectable arm.

29. The method of claim 27, wherein following the step of permitting the prosthetic heart valve to release from the delivery device, the method further comprising:

distally advancing the delivery sheath over the release member to force the release member to the compressed condition; and

removing the delivery device from the bodily lumen.