Prosthetic valve delivery system

• US 8,021,420 B2
• Filed: 03/12/2009
• Issued: 09/20/2011
• 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
• Primary Examiner(s): Tyson; Melanie
• Assistant Examiner(s): DANG, PHONG SON H
• Application Number:
  US12/403,114
• Publication Number:
  US 20100234940A1
• Time in Patent Office: 922 Days
• Field of Search: 623 21- 219, 623 111- 112, 623 115- 12, 623/1.23, 623/900
• US Class Current: 623/2.11
• 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.