Transcatheter Prosthetic Heart Valve Delivery Device with Biased Release Features

• US 20110264202A1
• 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: Kolden, Jason, Argentine, Jeffery, Murray, Robert J. III
• Granted Patent: US 8,852,271 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 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/008 paraboloidal

Abstract

A delivery system for percutaneously delivering and deploying a stented prosthetic heart valve. The delivery device includes a delivery sheath slidably disposed over an inner shaft, and a capture assembly. The capture assembly includes a spindle and a biasing member. The spindle is attached to the inner shaft and defines slot. The biasing member is disposed within the slot and self-transitions from a deflected condition to a normal condition. In a delivery state, the delivery sheath retains the prosthesis over the inner shaft and coupled to the spindle via the capture slot, including a portion of the prosthetic valve being engaged within the slot and the biasing member forced to the deflected condition. In a deployment state, the delivery sheath is proximally withdrawn and the biasing member self-transitions toward the normal condition to eject the prosthetic valve from the capture slot.

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 assembly terminating at a distal end and defining a lumen;

an inner shaft slidably disposed within the lumen; and

a capture assembly for selectively coupling a prosthetic heart valve relative to the inner shaft, the capture assembly including;

a spindle attached to the inner shaft, the spindle defining at least one longitudinal capture slot,

at least one biasing member disposed within the at least one capture slot and configured to self-transition from a deflected condition to a normal condition, wherein a radial projection of the biasing member relative to a centerline of the inner shaft is greater in the normal condition than in the deflected condition;

wherein the delivery device is configured to provide;

a delivery state in which the delivery sheath assembly retains a stented prosthetic heart valve over the inner shaft via the at least one capture slot, including a portion of a prosthetic heart valve engaged within the at least one capture slot and the at least one biasing member forced to the deflected condition,

a deployment state in which the distal end of the delivery sheath assembly is withdrawn from the at least one capture slot, including the at least one biasing member self-transitioning toward the normal condition to exteriorly close at least a portion of the capture slot.

2. The delivery device of claim 1, wherein the at least one capture slot includes a plurality of circumferentially spaced capture slots formed in the spindle.

3. The delivery device of claim 2, wherein the at least one biasing member includes a plurality of biasing members disposed within respective ones of the capture slots.

4. The delivery device of claim 1, wherein the spindle includes a distal hub and a proximal flange, the hub and the flange being longitudinally spaced from one another to define a circumferential trough.

5. The delivery device of claim 4, wherein the at least one capture slot is formed in the hub and is open to the trough.

6. The delivery device of claim 5, wherein the flange forms a longitudinal clearance slot that is longitudinally aligned with the at least one capture slot.

7. The delivery device of claim 5, wherein the at least one biasing member extends across the trough.

8. The delivery device of claim 5, wherein the at least one biasing member extends through at least a majority of the at least one capture slot in the normal condition.

9. The delivery device of claim 8, wherein at least a portion of the at least one biasing member projects radially beyond an outer surface of the hub in the normal condition.

10. The delivery device of claim 1, wherein the at least one biasing member is a leaf spring body defining a free end, a fixed end, and an intermediate region, the intermediate region having a shape memory curve shape in the normal condition.

11. The delivery device of claim 10, wherein the fixed end is spatially affixed relative to the spindle.

12. The delivery device of claim 11, wherein the at least one biasing member includes a plurality of biasing members, the fixed end of each of the biasing members being connected to a collar, and further wherein the collar is attached to the spindle.

13. The delivery device of claim 11, wherein the at least one biasing member is configured such that self-transitioning from the deflected condition to the normal condition includes the free end moving relative to the spindle.

14. The delivery device of claim 1, further comprising:

a release sleeve assembly disposed between the inner shaft and the delivery sheath assembly, the release sleeve assembly including a release sleeve slidably received over at least a portion of the spindle in the delivery state.

15. The delivery device of claim 14, wherein the release sleeve assembly is configured to proximally retract the release sleeve relative to the spindle with proximal retraction of the delivery sheath distal end from the release sleeve.

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 assembly terminating at a distal end and defining a lumen,

an inner shaft slidably disposed within the lumen,

a capture assembly for selectively coupling the prosthetic heart valve relative to the inner shaft, the capture assembly including;

a spindle attached to the inner shaft, the spindle defining at least one longitudinal capture slot,

at least one biasing member disposed within the at least one capture slot and configured to self-transition from a deflected condition to a normal condition, wherein a radial projection of the biasing member relative to a centerline of the inner shaft is greater in the normal condition than in the deflected condition;

wherein the system is configured to provide a loaded mode in which the prosthetic heart valve is retained within the delivery sheath assembly and to the inner shaft, including the at least one post slidably captured within the at least one capture slot and forcing the at least one biasing member to the deflected condition.

17. The system of claim 16, wherein the at least one capture slot includes a plurality of circumferentially spaced capture slots formed in the spindle.

18. The system of claim 17, wherein the at least one biasing member includes a plurality of biasing members disposed within respective ones of the capture slots.

19. The system of claim 16, wherein the spindle includes a distal hub and a proximal flange, the hub and the flange being longitudinally spaced from one another to define a circumferential trough.

20. The system of claim 19, wherein the at least one capture slot is defined in the hub and is open to the trough, and further wherein the at least one biasing member extends across the trough.

21. The system of claim 16, wherein the delivery device further comprises:

a release sleeve assembly disposed between the inner shaft and the delivery sheath assembly, the release sleeve assembly including a release sleeve slidably received over at least a portion of the spindle in the loaded mode.

22. The system of claim 21, wherein the release sleeve is configured to retain a portion of the prosthetic heart valve within the at least one capture slot, causing the portion to force the at least one biasing member to the deflected condition.

23. The system of claim 16, wherein the system is further configured to provide a deployment mode in which the distal end of the delivery sheath is proximal the at least one capture slot and the at least one biasing member self-transitions to the normal condition to eject the at least one post from the at least one capture slot.

24. A method of 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 assembly containing the prosthetic heart valve in a compressed arrangement over an inner shaft in a delivery state of the device, and a capture assembly attached to the inner shaft, the capture assembly including;

a spindle attached to the inner shaft and defining at least one longitudinal capture slot,

at least one biasing member disposed within the at least one capture slot and configured to self-transition from a deflected condition to a normal condition,

wherein a post of the stent frame is slidably disposed within the at least one capture slot in the delivery state in a manner forcing the at least one biasing member to the deflected condition;

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 assembly from the prosthetic heart valve; and

permitting the post to release from the at least one capture slot, including the at least one biasing member self-transitioning toward the normal condition to eject the post from the at least one capture slot.

25. The method of claim 25, wherein the at least one capture slot includes a plurality of circumferentially spaced capture slots, the at least one biasing member includes a plurality of biasing members, respective ones of which are disposed in corresponding ones of the capture slots, and the at least one post includes a plurality of posts corresponding with the plurality of capture slots.

26. The method of claim 25, wherein the delivery device further includes:

a release sleeve assembly disposed between the delivery sheath assembly and the inner shaft, the release sleeve assembly including a release sleeve slidably disposed over the spindle in the delivery state to retain the post in the at least one capture slot.

28. The method of claim 27, wherein the delivery state includes the release sleeve imparting a compressive force onto the at least one biasing member via the at least one post, and further wherein the step of permitting the post to release from the at least one capture slot includes proximally retracting the release sleeve from over the at least one capture slot.