System and method for implanting cardiac valves

• US 5,840,081 A
• Filed: 02/19/1997
• Issued: 11/24/1998
• Est. Priority Date: 05/18/1990
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Original Assignee: Henning R. Andersen, John M. Hasenkam, Lars L. Knudsen
• Inventors: Hasenkam, John Michael, Knudsen, Lars Lyhne, Andersen, Henning Rud
• Primary Examiner(s): Willse, David H.
• Application Number:
  US08/801,036
• Time in Patent Office: 643 Days
• Field of Search: 623/2, 623/900, 606/108, 600/36
• US Class Current: 623/1.11
• 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 2/2475 Venous valves
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: Y10S 623/90 Stent for heart valve
• CPC Class Codes: Y10S 623/904 Heart

Abstract

A valve prosthesis (9) for implantation in the body by use of catheter (11) comprises a stent made from an expandable cylinder-shaped thread structure (2,3) comprising several spaced apices (4). The elastically collapsible valve (4) is mounted on the stent as the commissural points (5) of the valve (6) are secured to the projecting apices (4).

The valve prosthesis (9) can be compressed around the balloon means (13) of the balloon catheter (11) and be inserted in a channel, for instance in the aorta (10). When the valve prosthesis is placed correctly the balloon means (13) is inflated thereby expanding the stent and wedging it against the wall of aorta. The balloon means is provided with beads (14) to ensure a steady fastening of the valve prosthesis on the balloon means during insertion and expansion.

The valve prosthesis (9) and the balloon catheter (11) make it possible to insert a cardiac valve prosthesis without a surgical operation comprising opening the thoracic cavity.

Claims

1. A system for implanting a valve in a body channel having an inner wall, the system comprising:

a radially collapsible and expandable cylindrical stent;

a radially collapsible and expandable valve mounted to the stent; and

a catheter for introducing and securing the valve in the body channel, the catheter comprising an expandable member about which the cylindrical stent may be positioned together with the valve, fastening means on the expandable member on which the stent may be mounted to the expandable member, and a channel extending through the catheter for injecting a fluid into the expandable member so as to expand the expandable member from a collapsed profile suitable for introduction into the body channel to an expanded profile in which the stent engages the inner wall of the body channel so as to secure the valve therein.

2. A system as in claim 1 wherein the expandable member comprises a balloon.

3. A system as in claim 2 wherein the fastening means comprises a plurality of beads on the surface of the balloon.

4. A system as in claim 1 wherein the valve comprises a trilobate valve having a plurality of commissural points.

5. A system as in claim 4 wherein the stent comprises a plurality of circumferentially spaced apices for supporting the commissural points of the valve.

6. A system as in claim 5 wherein the stent comprises at least one wire bent so as to form a plurality of circumferentially spaced loops, a first portion of the loops comprising the apices for supporting the commissural points of the valve, and a second portion of the loops lying between the apices to allow the stent to radially expand and collapse.

7. A method of implanting a valve in a body channel having a wall, the method comprising:

introducing a catheter into the body channel, the catheter including an expandable member near a distal end thereof, a fluid channel in communication with the expandable member, and a cylindrical stent mounted to the expandable member, the valve being mounted to the cylindrical stent, wherein the expandable member, the stent and the valve are in a collapsed configuration during said introducing;

advancing the catheter within the body channel to a position wherein the valve is to be implanted; and

radially expanding the expandable member together with the cylindrical stent and the valve by injecting a fluid through the fluid channel such that the stent engages the wall of the body channel so as to be secured therein.

8. The method of claim 7 wherein the step of radially expanding comprises inflating a balloon on the catheter with the fluid delivered through the fluid channel, the cylindrical stent being disposed about the balloon so as to expand therewith.