DELIVERY SYSTEMS FOR PROSTHETIC HEART VALVE

• US 20130030520A1
• Filed: 07/26/2012
• Published: 01/31/2013
• 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, Ulrich, Timothy C.
• Granted Patent: US 9,119,716 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• 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 delivery device for implantation of a prosthetic device within the body, the prosthetic device being radially expandable from a radially compressed state to a radially expanded state, the delivery device comprising:

an inflatable balloon; and

a proximal stop and a distal stop configured to limit longitudinal movement of the prosthetic device relative to the balloon while the prosthetic device is mounted over the balloon in the radially compressed state between the proximal stop and the distal stop;

wherein the proximal stop and the distal stop each comprise an end portion positioned within the balloon and configured to be positioned adjacent a respective end of the prosthetic device when the prosthetic device is radially compressed between the proximal and distal stops, each of the end portions comprising at least one longitudinally extending slot that allows the end portion of the respective stop to be radially compressed to a smaller diameter.

2. The delivery device of claim 1, wherein the at least one longitudinally extending slot in each stop end portion is configured to allow a balloon-inflation fluid to flow radially through the respective stop.

3. The delivery device of claim 2, wherein, when the prosthetic device is mounted on the delivery device in the radially compressed state, the proximal stop and the distal stop are configured to allow a balloon-inflation fluid to flow from a proximal portion of the balloon, through the at least one slot in the proximal stop, through an intermediate portion of the balloon positioned within the prosthetic device, through the at least one slot in the distal stop, and into a distal portion of the balloon.

4. The delivery device of claim 1, wherein a proximal end of the balloon is attached to the proximal stop and a distal end of the balloon is attached to the distal stop.

5. The delivery device of claim 1, wherein the delivery device further comprises an outer shaft having a lumen and an inner shaft extending through the lumen of the outer shaft, wherein the proximal stop is attached to a distal end of the outer shaft and/or attached to an outer surface of the inner shaft, and wherein the distal stop is attached to an outer surface of the inner shaft.

6. The delivery device of claim 5, wherein the proximal stop further comprises:

a proximal portion attached to the distal end of the outer shaft and to a proximal end of the balloon; and

an intermediate portion between the proximal portion and the end portion, the intermediate portion having an outer diameter that is less than an outer diameter of the proximal portion and less than the diameter of the end portion.

7. The delivery device of claim 5, wherein the proximal stop is attached to the distal end of the outer shaft and further comprises at least one fluid passageway that allows an inflation fluid to flow through the at least one passageway and into the balloon.

8. The delivery device of claim 5, wherein the distal stop further comprises:

a distal portion attached to a distal end of the balloon; and

an intermediate portion between the distal portion and the end portion, the intermediate portion having an outer diameter that is less than an outer diameter of the distal portion and less than the diameter of the end portion.

9. The delivery device of claim 1, wherein the end portion of each stop decreases in diameter in a direction extending away from the prosthetic device.

10. The delivery device of claim 1, wherein the delivery device further comprises a nosecone attached to a distal end of the distal stop.

11. The delivery device of claim 1, wherein at least one of the stop end portions comprises at least three longitudinal slots that allow the stop end portion to be radially compressed to a smaller diameter when the prosthetic device is crimped onto the delivery device.

12. The delivery device of claim 1, in combination with a prosthetic heart valve crimped onto the balloon between the proximal and distal stops.

13. A method of implanting a prosthetic heart valve within the 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.

14. The method of claim 13, 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.

15. The method of claim 13, 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.

16. The method of claim 15, further comprising, prior to introducing the delivery device into the heart, crimping the prosthetic heart valve to the radially compressed state onto delivery device while simultaneously radially compressing the proximal stop and the distal stop.

17. The method of claim 16, wherein the prosthetic heart valve has a first outer diameter in the radially compressed state and the proximal stop and distal stop are compressed from a second outer diameter to about the first outer diameter during the crimping.

18. The method of claim 17, wherein, when compressive pressure is released after the crimping, the proximal stop and distal stop resiliently expand from about the first outer diameter to about the second outer diameter.

19. The method of claim 13, wherein introducing the distal end portion of a delivery device into the native aortic valve of the heart comprises inserting the distal end portion of a delivery device through an incision in a patient'"'"'s chest to reach the heart.

20. A system for delivering a prosthetic device into a patient, comprising:

an introducer sheath configured to be inserted partially into a patient;

a loader configured to be inserted into a proximal end the introducer sheath; and

a delivery device configured to be passed through the loader and the introducer sheath into the patient carrying a prosthetic device to be implanted in the patient;

wherein the loader comprises a flush port for selectively introducing fluid into the loader and a bleed port for selectively releasing fluid from within the loader, and both the flush port and the bleed port are sealed with a resiliently flexible annular sealing member.

21. The system of claim 20, wherein the sealing member comprises push tab that extends radially through the bleed port, such that the bleed port is configured to be selectively opened by depressing the push tab in the radially inward direction.