Device and method for assisting in the implantation of a prosthetic valve

• US 20060004439A1
• Filed: 06/29/2005
• Published: 01/05/2006
• Est. Priority Date: 06/30/2004
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Private Incorporated (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences Private Incorporated (Edwards Lifesciences Corporation)
• Inventors: Spenser, Benjamin, Bash, Assaf, Tubishevitz, Amit, Benichou, Netanel
• Granted Patent: US 7,462,191 B2
• Time in Patent Office: Days
• US Class Current: 623/1.230
• 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

Abstract

A system for percutaneously introducing a prosthetic valve into a patient'"'"'s vasculature comprises a balloon dilatation catheter, a prosthetic valve mounted coaxial to the dilatation balloon, and a pusher member comprising a longitudinally extending tubular member encompassing the shaft of the catheter. The distal end of the pusher member preferably corresponds to the proximal end of the stent component of the prosthetic valve. The pusher member provides enhanced longitudinal pushability for facilitating advancement of the prosthetic valve to a treatment site. The system is well-suited for advancing a prosthetic valve or other medical device through an introducer sheath having a relatively small inner diameter. The introducer sheath may be formed with a tapered proximal end portion for receiving the prosthetic valve and for reducing a diameter of the prosthetic valve during advancement therethrough.

Claims

1. A system for percutaneously introducing a prosthetic valve into a patient'"'"'s vasculature, comprising:

a balloon dilatation catheter having an elongate shaft and a dilatation balloon disposed along a distal end portion;

a prosthetic valve formed with an expandable stent member and a valvular structure, the prosthetic valve being positioned coaxially to the dilatation balloon; and

a pusher member formed with a longitudinal slot for accepting the elongate shaft, the pusher member having a distal end corresponding to a proximal end of the expandable stent for transferring longitudinal forces to the expandable stent from a location outside the patient'"'"'s vasculature, the pusher member being slidable relative to the elongate shaft.

2. The system of claim 1, wherein the longitudinal slot comprises at least one area that is wider than a remaining portion of the slot.

3. The system of claim 1, further comprising a cover member positioned over a distal end of the dilatation balloon, the cover member having two or more substantially equally spaced openings arranged around the cover member.

4. The system of claim 3, wherein the dilatation balloon expands through the openings as the dilatation balloon is inflated.

5. The system of claim 1, further comprising a cover member positioned over a distal end of the dilatation balloon, the cover member comprises a multitude of substantially equally sized members that form a substantially conical shape before the balloon is inflated.

6. The system of claim 1, further comprising a cooperating sealing member that can be advanced distally over the pusher member.

7. The system of claim 1, wherein the pusher member further comprises at least one internal support member.

8. A system for assisting in introduction and implantation in a body lumen of a crimped stent-mounted percutaneous valve assembly, the valve assembly carried on a delivery catheter comprising a shaft and stent expansion mechanism, the system comprising:

a pusher member comprising a slotted tube that accepts the shaft, the distal end of the pusher member being sized for contact with a proximal end of the valve assembly;

an introducer sheath formed with a tapered opening configured to provide further crimping of the assembly when the valve assembly is longitudinally advanced through the tapered opening;

a tapering along a distal end of the valve assembly enabling the valve assembly to avoid catching on obstructions in the lumen.

9. The system of claim 8, wherein the slot in the pusher member comprises at least one area that is wider than a remaining portion of the slot.

10. The system of claim 8, further comprising a cooperating sealing member that can be advanced distally over the pusher member.

11. The system of claim 8, wherein the pusher member further comprises at least one internal support member.

12. The system of claim 8, wherein the expansion mechanism expands in such a fashion that the expansion mechanism contacts a portion of the body lumen, thereby anchoring the expansion mechanism and preventing longitudinal movement during deployment.

13. A method of introducing a prosthetic valve into a body lumen, comprising:

providing a balloon catheter having an elongate shaft and an expandable balloon, the prosthetic valve being disposed over the balloon;

snapping the elongate shaft into a slot formed in a pusher member, the pusher member having a distal end sized for contacting a proximal end of the prosthetic valve;

inserting an introducer sheath into the body lumen;

advancing the prosthetic valve through the introducer to a site of a native valve by applying longitudinal forces to the prosthetic valve via the pusher member;

withdrawing the pusher member relative to the prosthetic valve; and

inflating the balloon for expanding the prosthetic valve at the site of the native valve for replacing the function of the native valve.