System For Implanting a Valve Prosthesis

• US 20100286769A1
• Filed: 06/25/2010
• Published: 11/11/2010
• Est. Priority Date: 05/18/1990
• Status: Abandoned Application

• Current Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Inventors: Hasenkam, John Michael, Knudsen, Lars Lyhne, Andersen, Henning Rud
• Application Number:
  US12/823,428
• Publication Number:
  US 20100286769A1
• Time in Patent Office: Days
• 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 2/2475 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) is 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 the 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 prosthetic valve assembly for use in replacing a deficient native valve, the valve assembly comprising:

a valve having a plurality of leaflets, a base, and a plurality of commissure points;

a valve support comprising a generally cylindrical band comprising a plurality of expandable cells, the valve support configured to be collapsible for transluminal delivery and expandable to contact the anatomical annulus of the native valve when the assembly is positioned in situ, said generally cylindrical band of the valve support supporting the base and the commissure points of the valve.

2. The valve assembly of claim 1, wherein one or more of the commissure points of the valve are positioned and secured at or adjacent one of the expandable cells.

3. The valve assembly of claim 1, further comprising:

an anchor for engaging the lumen wall when expanded in place for preventing substantial migration of the valve assembly after deployment;

wherein the anchor is itself configured to be expandable, and wherein at least part of the anchor is positioned away from the generally cylindrical band of the valve support.

4. The valve assembly of claim 3, wherein the anchor has an expanded diameter that is different from the expanded diameter of the valve support.

5. The valve assembly of claim 1, further comprising:

an anchor for engaging the lumen wall when expanded in place for preventing substantial migration of the valve assembly after deployment;

wherein the anchor comprises one or more rings.

6. The valve assembly of claim 5, wherein the valve support is self-expanding and comprises a metallic material.

7. A method of replacing a deficient native valve comprising the steps of:

providing a prosthetic valve assembly, the assembly comprising a valve, a valve support comprising a plurality of expandable cells and having the base and the commissures of the valve positioned and secured at or adjacent the expandable cells;

collapsing the valve support and anchor to fit on a distal portion of a catheter;

advancing the catheter to the deficient native valve to a position within adjacent the leaflets and within the annulus of the deficient native valve;

deploying the valve assembly within the deficient native valve, whereby the valve support expands against the leaflets of the deficient native valve; and

withdrawing the catheter, leaving the valve assembly to function in place of the deficient native valve.

8. The method of claim 7, further comprising the step of positioning the valve support and anchor within a generally tubular sheath extending around the distal portion of the catheter.

9. The method of claim 7, wherein the anchor is self-expanding.

10. The method of claim 7, wherein the valve support is self-expanding.

11. The method of claim 7, wherein the valve support is balloon-expandable.

12. The method of claim 7, further comprising the step of securing a portion of the valve support to the catheter.

13. The method of claim 7, wherein deploying the valve assembly comprises the step of crushing the native valve leaflets against the native valve annulus.

14. The method of claim 7, wherein the prosthetic valve assembly further comprises an anchor for engaging a lumen wall for preventing substantial migration of the valve assembly when positioned in place.

15. The method of claim 14, wherein the anchor is spaced from the valve support.

16. A prosthetic valve assembly for use in replacing a deficient native valve, the valve assembly comprising:

a valve having a plurality of leaflets and commissure points;

a valve support comprising a plurality of expandable cells and a plurality of longitudinal bars, the valve support configured to be collapsible for transluminal delivery and expandable to contact the anatomical annulus of the native valve when the assembly is positioned in situ, said valve support supporting the base and the commissure points of the valve, wherein the commissure points of the valve are secured to the valve support at the longitudinal bars and adjacent one or more of the expandable cells.

17. The valve assembly of claim 16, wherein the valve support is self-expanding.

18. The valve assembly of claim 16, wherein the valve support is balloon expandable.

19. The valve assembly of claim 16, wherein the valve support is configured to press radially against the native valve leaflets to hold the native valve leaflets against walls of the native valve annulus and/or against walls of an adjacent lumen to thereby prevent the native valve leaflets from obstructing the native valve annulus.

20. The valve assembly of claim 16, wherein the longitudinal bars of the valve support further comprise a plurality of holes, wherein the plurality of leaflets are secured to the longitudinal bars via suture lines passing through the plurality of holes.