Delivery systems for prosthetic heart valve

• US 10,179,047 B2
• Filed: 08/14/2015
• Issued: 01/15/2019
• Est. Priority Date: 07/27/2011
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Lee, Walter, Dehdashtian, Mark, Jimenez, Teodoro S., Leung, Gilbert S., Janish, Bryan, Valdez, Michael G., Nguyen, Tram Ngoc, Ulrich, Timothy C.
• Primary Examiner(s): Stransky, Katrina
• Assistant Examiner(s): MENDOZA, MICHAEL G
• Application Number:
  US14/827,172
• Publication Number:
  US 20150342735A1
• Time in Patent Office: 1,250 Days
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/484 Fluid means, i.e. hydraulic or pneumatic
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/9586 the means being inside the balloon
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0021 differing in coefficient of friction
• CPC Class Codes: A61M 2025/1013 with concentrically mounted balloons, e.g. being independently inflatable
• CPC Class Codes: A61M 2025/1084 having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/10184 Means for controlling or monitoring inflation or deflation

Abstract

Described herein are systems and methods from delivering prosthetic devices, such as prosthetic heart valves, through the body and into the heart for implantation therein. The prosthetic devices delivered with the delivery systems disclosed herein are, for example, radially expandable from a radially compressed state mounted on the delivery system to a radially expanded state for implantation using an inflatable balloon of the delivery system. Exemplary delivery routes through the body and into the heart include transfemoral routes, transapical routes, and transaortic routes, among others.

Claims

1. A method of implanting a prosthetic heart valve within a heart, the method comprising:

introducing a distal end portion of a delivery device into the native aortic valve of the heart, a distal end portion of the delivery device comprising an inflatable balloon, a proximal stop and a distal stop positioned at least partially within the balloon, and a radially expandable prosthetic heart valve mounted over the balloon and between the proximal stop and the distal stop in a radially compressed state;

inflating the balloon to radially expand the prosthetic heart valve within the native aortic valve, wherein the balloon is inflated with an inflation fluid that flows radially through the proximal and distal stops;

deflating the balloon; and

retracting the delivery device from the heart;

wherein inflating the balloon comprises causing the inflation fluid to flow;

through a first passageway in the proximal stop and into a proximal portion of the balloon;

from the proximal portion of the balloon, through a second passageway in the proximal stop, and into an intermediate portion of the balloon within the prosthetic device; and

from the intermediate portion of the balloon, through a passageway in the distal stop, and into a distal portion of the balloon; and

wherein the passageway in the distal stop comprises a slot in a cone-shaped portion of the distal stop and inflation fluid flows radially through the slot.

2. The method of claim 1, wherein the proximal stop is positioned adjacent to a proximal end of the prosthetic heart valve and the distal stop is positioned adjacent to a distal end of the prosthetic heart valve, such that the prosthetic device is longitudinally contained between the proximal and distal stops during introduction of the delivery heart valve into the heart.

3. The method of claim 1, wherein the second passageway in the proximal stop comprises a slot in a cone-shaped portion of the proximal stop and inflation fluid flows radially through the slot.

4. The method of claim 1, wherein during inflation of the balloon, inflation fluid flows radially inwardly through the second passageway in the proximal stop and radially outwardly though the passageway in the distal stop.

5. The method of claim 1, wherein during inflation of the balloon, the proximal portion, intermediate portion, and distal portion of the balloon are inflated simultaneously.

6. The method of claim 1, further comprising, prior to introducing the delivery device into the heart, crimping the prosthetic heart valve to the radially compressed state onto the delivery device while simultaneously radially compressing the proximal and distal stops.

7. The method of claim 6, wherein the prosthetic heart valve has a first outer diameter in the radially compressed state and the proximal and distal stops are compressed from a second outer diameter to about the first outer diameter during the crimping.

8. The method of claim 7, further comprising releasing compressive pressure after the crimping such that the proximal and distal stops resiliently expand from about the first outer diameter to about the second outer diameter.

9. The method of claim 1, wherein introducing the distal end portion of the delivery device into the native aortic valve comprises delivering the distal end portion through the aorta to the native aortic valve.

10. The method of claim 1, wherein introducing the distal end portion of the delivery device into the native aortic valve comprises delivering the distal end portion through left ventricle to the native aortic valve.

11. The method of claim 1, wherein introducing the distal end portion of the delivery device into the native aortic valve comprises moving a pusher actuation mechanism on a handle portion of the delivery device, wherein the pusher actuation mechanism moves a pusher device adjacent the distal end of the balloon catheter such that the pusher device extends partially over the balloon and holds the prosthetic valve in place on the balloon as the prosthetic valve and balloon catheter are inserted through an introducer.

12. A method comprising:

positioning a radially compressible prosthetic heart valve around a distal end portion of a delivery device for delivering the prosthetic heart valve into the heart in a compressed state, the distal end portion of the delivery device comprising an inflatable balloon, a proximal stop, and a distal stop, the proximal and distal stops being positioned at least partially within the balloon;

crimping the prosthetic heart valve to a radially compressed state onto the distal end portion of a delivery device while simultaneously radially compressing the proximal stop and the distal stop, such that the prosthetic heart valve is positioned over the balloon and between the proximal and distal stops in a radially compressed state further comprising releasing compressive pressure after the crimping such that the proximal and distal stops resiliently expand from about the first outer diameter to about the second outer diameter.

13. The method of claim 12, wherein the prosthetic heart valve has a first outer diameter in the radially compressed state and the proximal and distal stops are compressed from a second outer diameter to about the first outer diameter during the crimping.

14. The method of claim 12, further comprising releasing compressive pressure after the crimping such that the proximal and distal stops resiliently expand from about the first outer diameter to about the second outer diameter.

15. The method of claim 12, wherein the proximal stop comprises a cone-shaped portion and at least one slot in the cone-shaped portion that facilitates radial compression of the cone-shaped portion and allows inflation fluid to flow through the proximal stop.

16. The method of claim 12, wherein the distal stop comprises a cone-shaped portion and at least one slot in the cone-shaped portion that facilitates radial compression of the cone-shaped portion and allows inflation fluid to flow through the distal stop.

17. A method comprising:

positioning a radially compressible prosthetic heart valve around a distal end portion of a delivery device for delivering the prosthetic heart valve into the heart in a compressed state, the distal end portion of the delivery device comprising an inflatable balloon, a proximal stop, and a distal stop, the proximal and distal stops being positioned at least partially within the balloon;

crimping the prosthetic heart valve to a radially compressed state onto the distal end portion of a delivery device while simultaneously radially compressing the proximal stop and the distal stop, such that the prosthetic heart valve is positioned over the balloon and between the proximal and distal stops in a radially compressed state; and

wherein the proximal stop comprises a cone-shaped portion and at least one slot in the cone-shaped portion that facilitates radial compression of the cone-shaped portion and allows inflation fluid to flow through the proximal stop.

18. The method of claim 17, wherein the prosthetic heart valve has a first outer diameter in the radially compressed state and the proximal and distal stops are compressed from a second outer diameter to about the first outer diameter during the crimping.

19. A method comprising:

positioning a radially compressible prosthetic heart valve around a distal end portion of a delivery device for delivering the prosthetic heart valve into the heart in a compressed state, the distal end portion of the delivery device comprising an inflatable balloon, a proximal stop, and a distal stop, the proximal and distal stops being positioned at least partially within the balloon;

crimping the prosthetic heart valve to a radially compressed state onto the distal end portion of a delivery device while simultaneously radially compressing the proximal stop and the distal stop, such that the prosthetic heart valve is positioned over the balloon and between the proximal and distal stops in a radially compressed state; and

wherein the distal stop comprises a cone-shaped portion and at least one slot in the cone-shaped portion that facilitates radial compression of the cone-shaped portion and allows inflation fluid to flow through the distal stop.

20. The method of claim 19, wherein the prosthetic heart valve has a first outer diameter in the radially compressed state and the proximal and distal stops are compressed from a second outer diameter to about the first outer diameter during the crimping.

21. A method of implanting a prosthetic heart valve within a heart, the method comprising:

introducing a distal end portion of a delivery device into the native aortic valve of the heart, a distal end portion of the delivery device comprising an inflatable balloon, a proximal stop and a distal stop positioned at least partially within the balloon, and a radially expandable prosthetic heart valve mounted over the balloon and between the proximal stop and the distal stop in a radially compressed state;

inflating the balloon to radially expand the prosthetic heart valve within the native aortic valve, wherein the balloon is inflated with an inflation fluid that flows radially through the proximal and distal stops;

deflating the balloon; and

retracting the delivery device from the heart;

wherein inflating the balloon comprises causing the inflation fluid to flow;

through a first passageway in the proximal stop and into a proximal portion of the balloon;

from the proximal portion of the balloon, through a second passageway in the proximal stop, and into an intermediate portion of the balloon within the prosthetic device; and

from the intermediate portion of the balloon, through a passageway in the distal stop, and into a distal portion of the balloon; and

wherein during inflation of the balloon, inflation fluid flows radially inwardly through the second passageway in the proximal stop and radially outwardly though the passageway in the distal stop.

22. The method of claim 21, wherein the second passageway in the proximal stop comprises a slot in a cone-shaped portion of the proximal stop and inflation fluid flows radially through the slot.

23. The method of claim 21, wherein during inflation of the balloon, the proximal portion, intermediate portion, and distal portion of the balloon are inflated simultaneously.

24. The method of claim 21, further comprising:

prior to introducing the delivery device into the heart, crimping the prosthetic heart valve to the radially compressed state onto the delivery device while simultaneously radially compressing the proximal and distal stops, wherein the prosthetic heart valve has a first outer diameter in the radially compressed state and the proximal and distal stops are compressed from a second outer diameter to about the first outer diameter during the crimping; and

releasing compressive pressure after the crimping such that the proximal and distal stops resiliently expand from about the first outer diameter to about the second outer diameter.

25. A method of implanting a prosthetic heart valve within a heart, the method comprising:

introducing a distal end portion of a delivery device into the native aortic valve of the heart, a distal end portion of the delivery device comprising an inflatable balloon, a proximal stop and a distal stop positioned at least partially within the balloon, and a radially expandable prosthetic heart valve mounted over the balloon and between the proximal stop and the distal stop in a radially compressed state;

inflating the balloon to radially expand the prosthetic heart valve within the native aortic valve, wherein the balloon is inflated with an inflation fluid that flows radially through the proximal and distal stops;

deflating the balloon; and

retracting the delivery device from the heart;

the method further comprising, prior to introducing the delivery device into the heart, crimping the prosthetic heart valve to the radially compressed state onto the delivery device while simultaneously radially compressing the proximal and distal stops;

wherein the prosthetic heart valve has a first outer diameter in the radially compressed state and the proximal and distal stops are compressed from a second outer diameter to about the first outer diameter during the crimping; and

the method further comprising releasing compressive pressure after the crimping such that the proximal and distal stops resiliently expand from about the first outer diameter to about the second outer diameter.

26. The method of claim 25, wherein the proximal stop is positioned adjacent to a proximal end of the prosthetic heart valve and the distal stop is positioned adjacent to a distal end of the prosthetic heart valve, such that the prosthetic device is longitudinally contained between the proximal and distal stops during introduction of the delivery heart valve into the heart.

27. The method of claim 25, wherein the proximal stop comprises a cone-shaped portion having a first slot, the distal stop comprise a cone-shaped portion having a second slot, first and second slots allow the inflation fluid to flow radially through the first and second stops, and the first and second slots allow the first and second stops to radially compress and radially expand.