Prosthetic heart valve delivery system with spacing

• US 8,876,892 B2
• Filed: 04/21/2011
• Issued: 11/04/2014
• Est. Priority Date: 04/21/2010
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Tran, Don, Wiemeyer, Nathan, Deshmukh, Susheel
• Primary Examiner(s): Woo, Julian W
• Application Number:
  US13/091,949
• Publication Number:
  US 20110264200A1
• Time in Patent Office: 1,293 Days
• Field of Search: 623/2.1, 623/2.11, 623/2.14, 606/108, 606/200, 606/198
• 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

Abstract

A device for percutaneously deploying a stented prosthetic heart valve includes a distal portion, a spacing collar, and an outer collar. The distal portion provides a coupling structure configured to selectively engage the stented prosthetic heart valve. The spacing collar is located proximal to the distal portion. The spacing collar is transitionable from a loaded state to an activated state. The spacing collar in the loaded state has a radial dimension less than the spacing collar in the activated state. The outer collar is configured to be movable relative to the distal portion and the spacing collar. The outer collar is slidably disposed over the spacing collar to provide the loaded state and is slidably retracted from the spacing collar when in the activated state.

Claims

1. A device for percutaneously deploying a stented prosthetic heart valve, the device comprising:

a distal portion located at the distal end of an axis of the device and configured to selectively engage the stented prosthetic heart valve, wherein the distal portion includes a distal-most tip;

a spacing collar proximal to and axially spaced apart from the distal portion from the engaged stented prosthetic heart valve, the spacing collar transitionable from a loaded state to an activated state wherein the spacing collar in loaded state has a radial dimension less than the spacing collar in the activated state;

wherein the spacing collar is configured to be longitudinally spaced-apart along the axis and proximal to the engaged stented prosthetic heart valve while in the loaded state and the activated state, and wherein the spacing collar, distal most tip, and the engaged stented prosthetic heart valve are generally, longitudinally immovable with respect to each other along the axis;

a plurality of fingers each having a first end coupled to the spacing collar and a second end yieldably urged away from the spacing collar in a radial direction; and

an outer collar configured to be movable along the axis relative to the distal portion and the spacing collar such that the outer collar is slidably disposed over the spacing collar to provide the loaded state and is slidably retracted from the spacing collar when in the activated state.

2. The device of claim 1 where in the distal portion includes a tip and a coupling structure, wherein the coupling structure is configured to be selectively engaged with the stented prosthetic heart valve.

3. The device of claim 2 where in the coupling structure includes a spacer and a spindle, wherein the spacer is distally disposed on the device relative to the spindle.

4. The device of claim 3 wherein the spindle is configured to engage the stented prosthetic heart valve.

5. The device of claim 2 wherein the outer collar is slidably movable to be adjacent to the tip.

6. The device of claim 5 wherein the outer collar includes a marker band at a distal most tip of the outer collar.

7. The device of claim 1 and further comprising a handle located on the opposite end of the device from the distal portion.

8. The device of claim 7 wherein the handle includes actuating mechanisms configured to selectively disengage the prosthetic device from the distal portion.

9. The device of claim 7 wherein the handle includes actuating mechanisms configured to facilitate movement of the outer collar relative to the distal portion and the spacing collar.

10. The device of claim 1 wherein the spacing collar is configured to self-expand after the outer collar is retracted from the spacing collar.

11. The device of claim 10 wherein in the spacing collar includes a spacing member.

12. The device of claim 11 wherein the plurality of fingers are circumferentially spaced apart around the spacing member.

13. The device of claim 12 wherein the plurality of fingers includes four fingers.

14. The device of claim 11 wherein the plurality of self-expanding fingers are configured to be disposed proximate to the stented prosthetic heart valve in the loaded state.

15. The device of claim 1, wherein a proximal portion is configured to be operably coupled to a handle.

16. A delivery system for percutaneously deploying a stented prosthetic heart valve, the system comprising:

an inner shaft assembly extending along an axis of the delivery system, the inner shaft assembly including a distal-most tip and a distal portion providing a coupling structure configured to selectively engage the stented prosthetic heart valve;

a spacing collar disposed on the axis of the delivery system and proximal to the distal portion and the engaged stented prosthetic heart valve wherein the spacing collar, distal most tip, and the engaged stented prosthetic heart valve are generally, longitudinally immovable with respect to each other along the axis;

a plurality of circumferentially-spaced fingers each having a first end coupled to the spacing collar and a second end yieldably urged away from the spacing collar in a radial direction;

wherein the fingers are transitionable from a first state wherein the second end of the fingers are urged toward the spacing collar to a second state wherein the second end of the fingers are expanded away from the spacing collar wherein the fingers are configured to be longitudinally spaced-apart along the axis and proximal to the engaged stented prosthetic heart valve while in the first state and the second state; and

an outer collar disposed about the axis of the delivery system and slidably disposed over the distal portion including the coupling structure configured to be engaged with the stented prosthetic heart valve and the spacing collar including the plurality of fingers;

wherein the delivery system includes a loaded configuration wherein the outer collar is disposed over the spacing collar and the fingers are in the first state and an activated configuration wherein the outer collar is distally retracted from the spacing collar and the fingers are in the second state.

17. The delivery system of claim 16 wherein the plurality of circumferentially-spaced fingers are self-expanding.

18. The delivery system of claim 16 wherein the fingers are formed to be curved so that the second ends are radially directed back toward the delivery system.

19. The delivery system of claim 16 wherein the second ends of the fingers are proximal to the stented prosthetic heart valve in the loaded configuration.

20. A method of deploying a stented prosthetic heart valve to an implantation site having a vessel wall, the method comprising:

selectively engaging the stented prosthetic heart valve on a loaded axial delivery system having a distal portion configured to engage the stented prosthetic heart valve, wherein the distal portion includes a distal-most tip, wherein the delivery system includes a spacing mechanism proximal to and longitudinally spaced-apart from engaged stented prosthetic heart valve on an axis of the delivery system, and wherein the spacing mechanism, distal most tip, and the engaged stented prosthetic heart valve are generally, longitudinally immovable with respect to each other along the axis;

disengaging the stented prosthetic heart valve from the delivery system at a delivery location wherein at least a portion of the delivery system is urged against the vessel wall;

activating the spacing mechanism on the delivery system after the stented prosthetic heart valve is disengaged to space at least the portion of the delivery system away from the vessel wall, wherein the spacing mechanism includes a spacing collar and a plurality of circumferentially-spaced fingers each having a first end coupled to the spacing collar and a second end yieldably urged away from the spacing collar in a radial direction; and

retracting the activated delivery system from the stented prosthetic heart valve.

21. The method of claim 20 and further comprising advancing the delivery system in a loaded configuration with the stented prosthetic heart valve to the implantation site distal to an aortic arch prior to disengaging the stented prosthetic heart valve from the delivery system at the desired location.

22. The method of claim 20 wherein the disengaging the stented prosthetic heart valve from the delivery system includes proximally retracting an outer collar on the delivery system from the stented prosthetic heart valve.

23. The method of claim 20 where the activating the spacing mechanism includes proximally retracting an outer collar on the delivery system from the spacing mechanism.