Prosthetic Valve Delivery System

• US 20100234940A1
• Filed: 03/12/2009
• Published: 09/16/2010
• Est. Priority Date: 03/12/2009
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Dolan, Mark
• Granted Patent: US 8,021,420 B2
• Time in Patent Office: Days
• US Class Current: 623/2.110
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2250/0048 differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability
• CPC Class Codes: A61M 2025/0039 characterized by lumina being arranged coaxially
• CPC Class Codes: A61M 2025/004 characterized by lumina being arranged circumferentially
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A prosthetic valve delivery system for percutaneously delivering and deploying a prosthetic valve within an existing valve is disclosed. The delivery system includes a stented prosthetic valve having a balloon-expandable stent portion with a prosthetic valve disposed therein and at least one self-expanding stent portion. The delivery system further includes a dual balloon catheter having a first balloon on which the stented prosthetic valve is disposed during delivery and a second balloon. Upon delivery within the existing valve, the self-expanding stent portion contacts the existing valve and the first balloon expands the balloon-expandable stent portion to a first diameter such that the stented prosthetic valve is in a first stage deployment configuration. The second balloon then expands the balloon-expandable stent portion to a second diameter, greater than the first diameter, such that the stented prosthetic valve is in a second stage deployment configuration being fully deployed within the existing valve.

Claims

1. A prosthetic valve delivery system comprising:

a stented prosthetic valve having

a tubular stent assembly with a balloon-expandable stent portion attached to at least one self-expanding stent portion, and

a prosthetic valve component disposed within and secured to the balloon-expandable stent portion of the stent assembly; and

a dual balloon catheter having

a first balloon on which the stented prosthetic valve is disposed in a delivery configuration, the first balloon having a first working diameter for expanding the balloon-expandable stent portion to a first diameter, and

a second balloon having a second working diameter that is greater than the first working diameter of the first balloon for expanding the balloon-expandable stent portion to a second diameter greater than the first diameter.

2. The delivery system of claim 1 further comprising:

an outer tubular sheath defining a lumen in which the dual balloon catheter is slidingly disposed, wherein the outer tubular sheath radially constrains the at least one self-expanding stent portion of the stented prosthetic valve in the delivery configuration.

3. The delivery system of claim 2, wherein when the outer tubular sheath is proximally retracted relative to the self-expanding stent portion, the self-expanding stent portion deploys into an expanded configuration with the balloon-expandable stent portion of the stented prosthetic valve remaining collapsed on the first balloon in the delivery configuration.

4. The delivery system of claim 3, wherein expansion of the first balloon expands the balloon-expandable stent portion to the first diameter such that the stented prosthetic valve is in a first stage deployment configuration and released from the dual balloon catheter when the first balloon is deflated.

5. The delivery system of claim 4, wherein the second balloon is slidable within the balloon-expandable stent portion when the stented prosthetic valve is in the first stage deployment configuration.

6. The delivery system of claim 5, wherein expansion of the second balloon within the balloon-expandable stent portion expands the balloon-expandable stent portion to the second diameter such that the stented prosthetic valve is in a second stage deployment configuration.

7. The delivery system of claim 6, wherein in the second stage deployment configuration an outer surface of the balloon-expandable stent portion is brought into apposition with a surface of a treatment site.

8. The delivery system of claim 6, wherein the first balloon is disposed on the dual balloon catheter proximal of the second balloon.

9. The delivery system of claim 6, wherein the first balloon is disposed on the dual balloon catheter distal of the second balloon.

10. The delivery system of claim 1, wherein the balloon-expandable stent portion is attached at each end to a respective self-expanding stent portion.

11. A method of percutaneously delivering and deploying a prosthetic valve within an existing valve comprising:

tracking a prosthetic valve delivery system through the vasculature to the existing valve, wherein the prosthetic valve delivery system includes

a stented prosthetic valve having a balloon-expandable stent portion with a prosthetic valve component disposed therein and attached at each end to a respective self-expanding stent portion, and

a dual balloon catheter having a first balloon with a first working diameter around which the stented prosthetic valve is disposed during delivery and a second balloon having a second working diameter that is greater than the first working diameter;

positioning the first balloon with the stented prosthetic valve thereon within the existing valve to be replaced;

releasing the self-expanding stent portions of the stented prosthetic valve into contact with the existing valve;

expanding the first balloon to the first working diameter to expand the balloon-expandable stent portion of the stented prosthetic valve to a first diameter such that the stented prosthetic valve is in a first stage deployment configuration;

manipulating the dual balloon catheter to position the second balloon within the stented prosthetic valve in the first stage deployment configuration; and

expanding the second balloon to the second working diameter to expand the balloon-expandable stent portion of the stented prosthetic valve to a second diameter greater than the first diameter such that the stented prosthetic valve is in a second stage deployment configuration.

12. The method of claim 11, wherein in the first stage deployment configuration an outer surface of the balloon-expandable stent portion is spaced from the existing valve.

13. The method of claim 12, wherein in the second stage deployment configuration the outer surface of the balloon-expandable stent portion is in apposition with the existing valve.

14. The method of claim 11, wherein the prosthetic valve delivery system further includes an outer tubular sheath defining a lumen in which the dual balloon catheter is slidingly disposed whereby the outer tubular sheath radially constrains the self-expanding stent portions of the stented prosthetic valve during delivery.

15. The method of claim 14, wherein the step of releasing the self-expanding stent portions includes proximally retracting the outer tubular sheath relative to the dual balloon catheter to expose the self-expanding stent portions.

16. The method of claim 11, wherein the first balloon is positioned on the dual balloon catheter proximal of the second balloon.

17. The method of claim 16, wherein the step of manipulating the dual balloon catheter includes deflating the first balloon and proximally retracting the dual balloon catheter to dispose the second balloon within the stented prosthetic valve.

18. The method of claim 11, wherein the first balloon is positioned on the dual balloon catheter distal of the second balloon.

19. The method of claim 18, wherein the step of manipulating the dual balloon catheter includes deflating the first balloon and distally advancing the dual balloon catheter to dispose the second balloon within the stented prosthetic valve.

20. The method of claim 11, wherein the existing valve is a heart valve.

21. The method of claim 20, wherein during the step of expanding the first balloon blood flow continues through the heart.

22. The method of claim 11, wherein the first working diameter of the first balloon is less than a diameter of the existing valve.

23. The method of claim 22, wherein the second working diameter of the second balloon is substantially equal to the diameter of the existing valve.

24. The method of claim 11 further comprising:

visualizing the stented prosthetic valve in the first stage deployment configuration to assure proper deployment within the existing valve.