Support apparatus and heart valve prosthesis for sutureless implantation

• US 20050182486A1
• Filed: 02/13/2004
• Published: 08/18/2005
• Est. Priority Date: 02/13/2004
• Status: Active Grant

• Current Assignee: Shlomo Gabbay
• Original Assignee: Shlomo Gabbay
• Inventors: Gabbay, Shlomo
• Granted Patent: US 7,311,730 B2
• Time in Patent Office: Days
• US Class Current: 623/2.110
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Abstract

An apparatus is disclosed for supporting a heart valve at an annulus of an implantation site. The apparatus includes a base portion operative to maintain a circumferential dimension thereof. A plurality of fingers extend axially and radially outwardly from the first end of the support element. A heart valve can be located within the apparatus to provide a prosthesis that can be suturelessly implanted at an annulus of a patient.

Claims

1. A support apparatus to facilitate implantation of a heart valve prosthesis, comprising:

a base portion curved about an axis, the base portion having axially spaced apart first and second ends and configured to maintain a circumferential length thereof; and

a plurality of fingers extending radially outwardly and generally axially from the base portion, a first set of the fingers extending generally in first axial direction, a second set of the fingers extending generally in a second axial direction opposite the first axial direction, such that the first and second sets of fingers extend toward each other to form a clamp-like structure.

11. (canceled)

12. A heart valve prosthesis comprising

a base portion curved about an axis, the base portion having axially spaced apart first and second ends and configured to maintain a circumferential length thereof;

a plurality of fingers extending radially outwardly and generally axially from the base portion, a first set of the fingers extending generally in first axial direction a second set of the fingers extending generally in a second axial direction opposite the first axial direction, such that the first and second sets of fingers extend toward each other to form a clamp-like structure; and

a heart valve located substantially coaxially within the base portion, the base portion being located proximal an inflow annulus of the heart valve prosthesis.

2. The prosthesis of claim 12, the fingers arranged in a spaced apart relationship circumferentially along the base portion in which each adjacent pairs of the fingers extend in alternating ones of the first and second axial directions.

3. The prosthesis of claim 2, each of the fingers comprise an elongate rod having a first end at the base portion and extending arcuately outwardly and axially to terminate in a second end spaced radially apart from the base portion.

4. The prosthesis of claim 3, wherein the second end of at least one of the first and second sets of fingers are substantially coplanar with the base portion.

5. The prosthesis of claim 12, each of the fingers having a width that is greater than a thickness thereof.

6. The prosthesis of claim 12, wherein the fingers comprise a resilient material moveable from a first condition, in which the distal ends of the first and second sets of fingers are located to form the clamp-like structure, to a second condition, in which distal ends of the first and second sets of fingers are spaced apart and generally parallel with the base portion, and the fingers being capable of returning from the second to the first condition.

7. The prosthesis of claim 6, wherein the resilient material comprises a shape memory alloy.

8. The prosthesis of claim 6, further comprising a covering having first and second end portions spaced apart from each other by a generally tubular body portion that is located within the base portion, at least one of the first and second end portions extending radially outwardly from the tubular body portion so as to cover at least part of a respective one of the first and second sets of fingers.

9. The prosthesis of claim 8, each of the first and second end portions of the covering extends radially outwardly from the tubular body portion and connected to a respective one of the first and second sets of fingers, such that the first and second end portions are moveable as a function of movement of the first and second sets of the fingers for covering at least part of an axially exposed surface of the first and second sets of the fingers.

10. The prosthesis of claim 8, wherein the covering further comprises a biocompatible biological tissue material.

13. The prosthesis of claim 12, further comprising outflow extensions at the outflow end of the valve generally aligned with commissures of adjacent leaflets of the valve.

14. The prosthesis of claim 12, wherein the heart valve comprises one of a biological valve, a mechanical valve and a bio-mechanical valve.

15. The prosthesis of claim 12, further comprising a cylindrical member having an interior dimension substantially commensurate with an outer dimension of the base portion and operative to maintain the fingers in a generally co-cylindrical condition with the base portion while located within the cylindrical member, the fingers moving from the co-cylindrical condition toward an original condition corresponding to the clamp-like structure.

16. The prosthesis of claim 15, further comprising a bulbous portion located on an outer surface of the cylindrical member, the bulbous portion extending along at least a part of the circumference of the cylindrical member near a distal end thereof.

17. The prosthesis of claim 12, further comprising a biocompatible flexible material arranged for covering at least part of an axially exposed surface of at least one of the first and second sets of the fingers.

18. A heart valve prosthesis comprising:

a valve member that permits substantially unidirectional flow of fluid through the valve member;

a support element generally around at least a substantial part of a sidewall portion of the valve member to maintain a circumferential dimension thereof, the support element having axially spaced apart first and second ends;

a first set of substantially resilient fingers extending axially and radially outwardly from the first end of the support element; and

a second set of substantially resilient fingers extending axially and radially outwardly from the second end of the support element in a generally opposing relationship relative to the first set of fingers.

19. The prosthesis of claim 18, wherein the first and second sets of fingers are arranged in a spaced apart relationship circumferentially along the base portion, alternating ones of the first and second sets of fingers extend in different ones of the first and second axial directions.

20. The prosthesis of claim 18, each of the fingers having a width that is greater than a thickness thereof.

21. The prosthesis of claim 18, wherein the first and second sets of fingers comprise a resilient material moveable from a first condition, in which the distal ends of the first and second sets of fingers extend axially and radially to provide a generally clamp-like structure, to a second condition, in which distal ends of the first and second sets of fingers extend generally parallel relative to the base portion, the fingers being capable of returning from the second to the first condition.

22. The prosthesis of claim 21, wherein the resilient material comprises a shape memory alloy.

23. The prosthesis of claim 21, further comprising a covering of a biocompatible flexible material that extends from the base portion to cover at least a substantial part of an axially exposed surface of at least one of the first and second sets of the fingers.

24. The prosthesis of claim 23, the covering further comprising a biological tissue material.

25. The prosthesis of claim 23, the covering having first and second end portions spaced apart from each other by a generally tubular body portion that is located within the base portion, at least one of the first and second end portions extending radially outwardly from the tubular body portion so as to cover at least part of a respective one of the first and second sets of fingers.

26. The prosthesis of claim 25, each of the first and second end portions extending radially outwardly from the tubular body portion and connected to a respective one of the first and second sets of fingers, such that the first and second end portions are moveable with movement of the first and second sets of the fingers for covering at least part of an axially exposed surface of the first and second sets of the fingers.

27. The combination of claim 26, further comprising an implanter that includes a cylindrical member having an interior dimension substantially commensurate with an outer diameter of the base portion and operative to holder the first and second sets of fingers in the first condition while located within the cylindrical member, the first and second sets of fingers moving from the second condition to the first condition after being discharged from the cylindrical member.

28. The combination of claim 27, further comprising a bulbous portion on the outside of the cylindrical member that spans at least a part of the circumference of the cylindrical member.

29. The prosthesis of claim 18, further comprising outflow extensions at the outflow end of the valve member generally aligned with commissures of adjacent leaflets of the valve.

30. The prosthesis of claim 18, the valve member further comprising one of a biological tissue valve, a mechanical valve, and a bio-mechanical valve.