System for percutaneous delivery and removal of a prosthetic valve

• US 20070239254A1
• Filed: 04/07/2006
• Published: 10/11/2007
• Est. Priority Date: 04/07/2006
• Status: Abandoned Application

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Marchand, Philippe, Taylor, David, Khanna, Rajesh, Chia, Chris
• Application Number:
  US11/400,063
• Publication Number:
  US 20070239254A1
• Time in Patent Office: Days
• US Class Current: 623/1.110
• CPC Class Codes: A61B 2017/22035 for retrieving or repositioning foreign objects
• CPC Class Codes: A61B 2017/2215 having an open distal end
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2002/9528 for retrieval of stents

Abstract

A valve-retrieval device permits a non-deployed valve mounted on a balloon catheter to be retracted back into an introducer sheath for removal from a patient'"'"'s body. In particular embodiments, the valve-retrieval device is adapted to be placed on a balloon catheter shaft and then advanced over the shaft into the blood vessel via the introducer sheath. The valve-retrieval device has an expandable distal end portion that assumes an expanded shape when advanced out of the introducer sheath. The valve is positioned within or adjacent the distal end portion of the retrieval device, and the retrieval device and the balloon catheter are retracted together back into the introducer sheath. The distal end portion of the retrieval device, rather than the outer surface portion of the valve covered thereby, contacts the distal end and inner surface of the introducer sheath to facilitate retraction of the valve into the introducer sheath.

Claims

1. A system for positioning and/or removing a prosthetic valve through a blood vessel, comprising:

an introducer sheath that is insertable into the blood vessel, the introducer sheath having a proximal end, a distal end, and a lumen;

a delivery catheter comprising an expandable distal end portion, the valve being mounted on the expandable distal end portion, the catheter being configured to be advanced through the introducer sheath and into the blood vessel to an implantation site; and

a valve removal device having a distal end portion configured to be advanced through the introducer sheath and into the blood vessel, the distal end portion being configured to be placed in a position at least partially surrounding the valve after the valve is advanced out of the introducer sheath and then retracted back into the introducer sheath along with the valve and the catheter.

2. The system of claim 1, wherein the distal end portion of the removal device is expandable such that when the distal end portion of the removal device is advanced out of the introducer sheath and into the blood vessel, the distal end portion expands to a diameter that is greater than an outer diameter of the valve.

3. The system of claim 1, wherein the removal device comprises an elongated, hollow shaft portion extending from the distal end portion of the removal device and adapted to be placed over a shaft of the catheter and advanced over the catheter shaft and through the introducer sheath.

4. The system of claim 3, wherein the shaft portion of the removal device is formed with an elongated opening extending the entire length of the shaft portion so that when the catheter shaft is inserted through the introducer sheath, the removal device can be placed on the catheter shaft by inserting the catheter shaft through the elongated opening in the shaft portion of the removal device.

5. The system of claim 4, wherein the shaft portion of the removal device conforms to the outer surface of the catheter shaft to minimize blood flow between the shaft portion and the catheter shaft.

6. The system of claim 4, wherein the shaft portion of the removal device is configured to be snap-fitted onto the catheter shaft.

7. The system of claim 2, wherein the distal end portion of the removal device is generally spoon shaped.

8. The system of claim 2, wherein the distal end portion comprises a plurality of longitudinally extending valve-engaging segments that are radially expandable and contractible about an outer surface of the valve.

9. The system of claim 2, wherein the distal end portion is made of a self-expanding material.

10. The system of claim 1, wherein the distal end portion of the removal device is configured to prevent the valve from contacting the introducer sheath when the distal end portion and the valve are retracted back into the introducer sheath.

11. The system of claim 1, wherein the valve defines an outer diameter that is equal to or greater than the inner diameter of the lumen of the introducer sheath when the valve is advanced out of the introducer sheath.

12. The system of claim 1, further comprising a steerable flexible catheter adapted to extend over the delivery catheter and being operable to adjust the curvature of at least portion of the delivery catheter, and wherein the removal device is connected to a distal end portion of the flexible catheter.

13. The system of claim 12, wherein the distal end portion of the removal device comprises a plurality of longitudinally extending valve-engaging members that are radially expandable and contractible toward and away from each other between an expanded position to allow at least a portion of the valve to be positioned within the valve-engaging members and a collapsed position with the valve-engaging members contacting said portion of the valve.

14. The system of claim 13, wherein the valve-engaging members are resiliently retained in the expanded position and are caused to move to the collapsed position when the valve is urged against inner surface portions of the valve-engaging members.

18. The device of claim 1, wherein the distal end portion expands to a diameter that is greater than an outer diameter of the valve when the distal end portion is advanced out of the introducer sheath.

22. A method for removing through a blood vessel a prosthetic valve mounted on a balloon of a balloon catheter after the valve and balloon are advanced into the blood vessel via an introducer sheath inserted partially into the blood vessel, the method comprising:

inserting the valve-removal device of claim 1 into the introducer sheath and advancing the valve-removal device until its distal end portion extends past the distal end of the introducer sheath and into the blood vessel;

covering at least a portion of the valve with the distal end portion of the valve-removal device; and

retracting the distal end portion and the valve together back into the introducer sheath.

15. A valve-removal device for removing through a blood vessel a prosthetic valve mounted on a balloon of a balloon catheter after the valve and balloon are advanced into the blood vessel via an introducer sheath in the cardiovascular system, the device comprising an elongated shaft coupled to a valve-engaging distal end portion, the shaft being configured to be placed on a catheter shaft of the balloon catheter and advanced through the introducer sheath along the length of the catheter shaft, the distal end portion being configured to overlap at least a portion of the valve such that when the distal end portion and the valve are retracted together back into the introducer sheath assembly, the distal end portion shields the overlapped portion of the valve from the introducer sheath to facilitate retraction of the valve into the introducer sheath assembly.

16. The device of claim 15, wherein the valve-retrieval device has a length that is greater than the length of the introducer sheath to allow the device to be advanced or retracted through the introducer sheath by manually moving a proximal end portion of the shaft located outside of the introducer sheath.

17. The device of claim 15, wherein the shaft is split longitudinally the entire length of the shaft so that the device can be placed around the catheter shaft at any location along the length of the catheter shaft outside of the introducer sheath.

19. A system for positioning and/or removing a prosthetic valve through a blood vessel, comprising:

a balloon catheter comprising a balloon at a distal end portion thereof, the valve being mounted on the balloon; and

introducing means for introducing the balloon catheter into the blood vessel; and

valve removal means for retracting the valve and the balloon back into the introducing means after the valve and the balloon are advanced through the introducing means into the blood vessel.

20. The system of claim 19, further comprising adjustment means for adjusting the curvature of a distal end portion of the balloon catheter, the valve removal means being connected to the adjustment means.

21. The system of claim 19, wherein the valve removal means comprises an elongated shaft adapted to be placed on a shaft of the balloon catheter in a co-axial relationship and advanced over the balloon catheter shaft through the introducing means, the valve removal means further comprising at least one valve-engaging member configured to engage an outer surface portion of the valve and prevent the outer surface portion of the valve from contacting the introducing means when the valve and the valve-engaging member are retracted into the introducing means.

23. A method of removing a prosthetic valve through a blood vessel, the valve being mounted on a balloon of a balloon catheter and having been inserted into the blood vessel via an introducer sheath inserted partially into the blood vessel, the method comprising:

advancing a removal device through the introducer sheath until at least a distal end portion of the removal device is advanced out of the introducer sheath;

covering at least a portion of the valve with the distal end portion of the removal device; and

retracting the distal end portion together with the valve back into the introducer sheath and removing the removal device and the balloon catheter from the blood vessel via the introducer sheath.

24. The method of claim 23, wherein the distal end portion of the removal device prevents the valve from contacting the introducer sheath when both are retracted into the introducer sheath.

25. The method of claim 23, further comprising expanding the distal end portion of the removal device when the distal end portion is positioned in the blood vessel and wherein the act of covering at least a portion of the valve comprises covering at least a portion of the valve with the expanded distal end portion.

26. The method of claim 25, wherein the distal end portion is self-expanding and therefore expands when advanced out of the introducer sheath.

27. The method of claim 25, wherein the distal end portion comprises a plurality of valve-engaging members that are radially expandable and contractible toward and away from each other between an expanded position and a collapsed position, wherein the act of expanding the distal end portion comprises expanding the valve-engaging members and the act of covering at least a portion of the valve comprises collapsing the valve-engaging members against said portion of the valve.

28. The method of claim 27, wherein the act of collapsing the valve-engaging members comprising urging the valve against inner surface portions of the valve-engaging members to cause the valve-engaging members to move to the collapsed position.

29. The method of claim 23, wherein the act of advancing a removal device through the introducer sheath comprises snap-fitting the removal device onto a shaft of the balloon catheter and sliding the removal device along the balloon catheter shaft through the introducer sheath.

30. A method of removing a prosthetic valve through a blood vessel, the valve being mounted on the balloon of a balloon catheter and having been inserted into the blood vessel via an introducer sheath inserted partially into the blood vessel, the method comprising:

partially inflating the balloon such that a proximal end portion and a distal end portion of the balloon not supporting the valve are distended to a diameter greater than the outer diameter of the valve; and

retracting the partially inflated balloon with the valve back into the introducer sheath.

31. The method of claim 30, wherein the act of partially inflating the balloon does not cause the valve to expand.