Prosthetic valve delivery system

• US 9,144,667 B2
• Filed: 08/14/2012
• Issued: 09/29/2015
• 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): Anderson, Gregory
• Assistant Examiner(s): DANG, PHONG SON H
• Application Number:
  US13/585,210
• Publication Number:
  US 20120310334A1
• Time in Patent Office: 1,141 Days
• Field of Search: 623 11- 112, 623 115- 219, 623/1.23, 623/900
• US Class Current: 1/1
• 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 and a prosthetic valve component for deployment within a native valve, wherein the tubular stent assembly comprises a self-expanding portion and a balloon-expandable portion, and wherein the prosthetic valve component is disposed within and secured to the balloon-expandable stent portion of the tubular stent assembly;

a delivery catheter having a first valve delivery location about which the entire stented prosthetic valve is disposed in a delivery configuration, and a second valve delivery location, located distally from the first valve delivery location, having a balloon for expanding the balloon-expandable portion of the stented prosthetic valve, wherein no portion of the stented prosthetic valve is disposed on the balloon of the second valve delivery location in the delivery configuration, and

an outer sheath slidably disposed about the first and second valve delivery locations of the delivery catheter, wherein the outer sheath radially constrains the self-expanding portion of the stented prosthetic valve in the delivery configuration at the first valve delivery location and wherein retraction of the outer sheath proximal of the first valve delivery location deploys the self-expanding portion of the stented prosthetic valve into an expanded configuration with the balloon-expandable portion of the stented prosthetic valve remaining in the delivery configuration on the first valve delivery location,

wherein the first valve delivery location has a first diameter and the second valve delivery location has a second diameter, wherein the second diameter is greater than or equal to the first diameter, and

wherein the second diameter can be expanded by inflation of the balloon.

2. The delivery system of claim 1,

wherein disposing the stented prosthetic valve about the first valve delivery location prior to the second valve delivery location reduces an overall diameter of the delivery system.

3. The delivery system of claim 1, wherein the first diameter is less than a diameter of a body lumen where the stented prosthetic valve is to be implanted, and the second diameter can be expanded to a diameter approximately equal to the body lumen where the stented prosthetic valve is to be implanted.

4. The delivery system of claim 1, wherein the delivery system can be manipulated to dispose the stented prosthetic valve about the second delivery location after being disposed about the first delivery location.

5. The delivery system of claim 1, wherein the balloon-expandable portion of the stented prosthetic valve is crimped about the first valve delivery location.

6. The delivery system of claim 1, wherein the delivery catheter further comprises a distal tip, wherein the distal tip is tapered from a proximal end to a distal end.

7. The delivery system of claim 1, wherein the delivery catheter is a flexible, steerable delivery catheter.

8. The delivery system of claim 1, wherein the delivery catheter further comprises a guide wire lumen.

9. The delivery system of claim 8, further comprising a guide wire.

10. A prosthetic valve delivery system comprising:

a stented prosthetic valve having a tubular stent assembly and a prosthetic valve component for deployment within a native valve,

wherein a self-expanding portion of the tubular stent assembly is configured to contact native valve leaflets and to provide a radial force to displace the native valve leaflets to hold the stented prosthetic valve in a deployment location;

a delivery catheter having a proximal valve delivery location with a proximal balloon about which the entire stented prosthetic valve is disposed in a collapsed delivery configuration, and a distal valve delivery location, located distally from the proximal valve delivery location, having a distal balloon for expanding the stented prosthetic valve, wherein no portion of the stented prosthetic valve is disposed on the distal balloon of the distal valve delivery location in the collapsed delivery configuration, and

an outer sheath slidably disposed about the proximal and distal valve delivery locations of the delivery catheter, wherein the outer sheath radially constrains the self-expanding portion of the stented prosthetic valve in the collapsed delivery configuration at the proximal valve delivery location, and wherein retraction of the outer sheath proximal of the proximal valve delivery location deploys the self-expanding portion of the stented prosthetic valve into an expanded configuration while a remaining portion of the stented prosthetic valve remains in the collapsed delivery configuration on the proximal balloon of the proximal valve delivery location, and

wherein the proximal balloon of the proximal valve delivery location has a first diameter and the distal balloon of the distal valve delivery location has a second diameter, wherein the second diameter is greater than or equal to the first diameter.

11. The delivery system of claim 10, wherein the remaining portion of the stented prosthetic valve includes a balloon-expandable stent portion of the tubular stent assembly.

12. The delivery system of claim 11, wherein the prosthetic valve component is disposed within and secured to the balloon-expandable stent portion of the stent assembly.