Heart valve structures

• US 20030171805A1
• Filed: 02/13/2003
• Published: 09/11/2003
• Est. Priority Date: 02/14/2002
• Status: Active Grant

• Current Assignee: St. Jude Medical (Abbott Laboratories Incorporated)
• Original Assignee: St Jude Medical Incorporated (Abbott Laboratories Incorporated)
• Inventors: Weston, Matthew W., Peterson, Alex A., Berg, Todd A.
• Granted Patent: US 7,252,681 B2
• Time in Patent Office: Days
• US Class Current: 623/2.14
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Abstract

A replacement heart valve structure includes a structure of tissue which is an intact, mammalian heart valve that has been harvested and treated to preserve it. A conventional fabric sleeve is typically disposed concentrically around the outside of the tissue structure. A support structure is included to facilitate implanting the heart valve by somewhat increasing the stability of the heart valve structure, but without unduly rigidifying it. An annular sewing cuff may be added adjacent the blood inflow end of the valve structure to facilitate making the annular suture line that is required at that end.

Claims

1. A replacement heart valve structure for implanting into a patient comprising:

a heart valve tissue structure that has been harvested from a mammal and preserved, the tissue structure having an annular blood outflow edge portion that undulates in the axial direction as one proceeds annularly around the outflow edge portion; and

a resilient support structure that at least radially supports at least parts of the blood outflow edge portion.

2. The replacement heart valve structure defined in claim 1 wherein the support structure comprises:

a ring that extends annularly around the tissue structure.

3. The replacement heart valve structure defined in claim 2 wherein the ring undulates to substantially follow the undulation of the blood outflow edge portion.

4. The replacement heart valve structure defined in claim 3 wherein the support structure is secured to the tissue structure substantially all the way around the outflow edge portion.

5. The replacement heart valve structure defined in claim 1 wherein the support structure is made of metal.

6. The replacement heart valve structure defined in claim 5 wherein the metal is selected from the group consisting of nitinol, stainless steel, and titanium.

7. The replacement heart valve structure defined in claim 1 wherein the support structure comprises nitinol wire having diameter in the range from about 0.010 in to about 0.018 in.

8. The replacement heart valve structure defined in claim 1 wherein the support structure is made of plastic.

9. The replacement heart valve structure defined in claim 8 wherein the plastic is selected from the group consisting of urethanes and acetyls.

10. The replacement heart valve structure defined in claim 1 wherein the support structure comprises:

a sleeve that extends annularly around at least an axial portion of the tissue structure.

11. The replacement heart valve structure defined in claim 1 wherein the support structure is configured to resiliently bias at least a portion of the tissue structure radially outwardly.

12. The replacement heart valve structure defined in claim 1 wherein the support structure comprises:

a plurality of separate, annularly spaced segments.

13. The replacement heart valve structure defined in claim 12 wherein at least one of the segments includes an aperture adapted for passage of a suture therethrough.

14. The replacement heart valve structure defined in claim 1 wherein the support structure also has an annular blood inflow edge portion, and wherein the replacement heart valve structure further comprises:

a second resilient support structure that at least radially supports parts of the tissue structure adjacent the blood inflow edge portion.

15. The replacement heart valve structure defined in claim 14 wherein the first and second support structures are connected to one another at a plurality of locations that are annularly spaced from one another around the replacement heart valve structure.

16. The replacement heart valve structure defined in claim 1 further comprising:

a fabric sleeve disposed annularly around the outside of the tissue structure.

17. The replacement heart valve structure defined in claim 16 wherein the support structure is captured between the tissue structure and the fabric sleeve.

18. The replacement heart valve structure defined in claim 1 wherein the tissue structure also has an annular blood inflow edge portion that undulates in the axial direction as one proceeds annularly around the inflow edge portion.

19. The replacement heart valve structure defined in claim 1 further comprising:

a radially outwardly projecting cuff that extends annularly around the tissue structure for facilitating suturing of the replacement heart valve structure to the patient'"'"'s tissue.

20. The replacement heart valve structure defined in claim 19 wherein the tissue structure also has an annular blood inflow edge portion, and wherein the cuff is adjacent the blood inflow edge portion.

21. The replacement heart valve structure defined in claim 19 wherein the cuff comprises material that can be penetrated by a suture needle.

22. The replacement heart valve structure defined in claim 1 further comprising:

structure for releasably deflecting free end portions of the blood outflow edge portion radially inwardly.

23. A replacement heart valve structure for implanting into a patient comprising:

a heart valve that has been harvested from a mammal and preserved, the heart valve having a tubular outer portion including a plurality of commissure posts and a plurality of valve leaflets extending into the interior of the tubular portion between the commissure posts; and

a support structure extending annularly around the heart valve adjacent the commissure posts for providing at least some radial support to the commissure posts.

24. The replacement heart valve structure defined in claim 23 wherein the support structure is radially flexible but resilient.

25. The replacement heart valve structure defined in claim 23 wherein the support structure comprises a metal ring.

26. The replacement heart valve structure defined in claim 23 wherein the support structure comprises a tubular sleeve.

27. The replacement heart valve structure defined in claim 23 wherein the support structure is configured to resiliently deflect the commissure posts radially outwardly.

28. The replacement heart valve structure defined in claim 23 wherein the tubular portion further comprises an axial recess between each annularly adjacent pair of the commissure posts, and wherein the support structure undulates axially to substantially follow the commissure posts and recesses annularly around the heart valve.

29. The replacement heart valve structure defined in claim 23 further comprising:

a radially outwardly projecting sewing cuff that extends annularly around the heart valve.

30. The replacement heart valve structure defined in claim 29 wherein the sewing cuff is adjacent an axial end of the heart valve that is remote from the commissure posts.

31. The replacement heart valve structure defined in claim 29, wherein the sewing cuff is penetrable by a suture needle.

32. The replacement heart valve structure defined in claim 23 further comprising:

structure for releasably deflecting free end portions of the commissure posts and associated portions of the support structure radially inwardly toward one another.