Support apparatus to facilitate implantation of cardiac prosthesis

• US 20070067029A1
• Filed: 11/28/2005
• Published: 03/22/2007
• Est. Priority Date: 09/16/2005
• Status: Abandoned Application

• Current Assignee: Shlomo Gabbay
• Original Assignee: Shlomo Gabbay
• Inventors: Gabbay, Shlomo
• Application Number:
  US11/287,623
• Publication Number:
  US 20070067029A1
• Time in Patent Office: Days
• US Class Current: 623/2.130
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 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 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Abstract

An apparatus includes substantially rigid and annular base portion having a radially outer sidewall portion and having a radially inner sidewall portion that defines an opening that extends axially through the base portion. A first rim portion extends substantially radially outwardly from the radially outer sidewall portion. A second rim portion extends substantially radially outwardly from the radially outer sidewall portion at an axial location that is spaced apart from the first rim portion so as to define a substantially continuous annular channel that extends circumferentially along the radially outer sidewall portion intermediate the first rim portion and second rim portion. The apparatus can be covered with a substantially biocompatible material.

Claims

1. An implantable apparatus, comprising:

a substantially rigid and annular base portion having a radially outer sidewall portion and having a radially inner sidewall portion that defines an opening that extends axially through the base portion;

a first rim portion extending substantially radially outwardly from the radially outer sidewall portion; and

a second rim portion extending substantially radially outwardly from the radially outer sidewall portion at an axial location that is spaced apart from the first rim portion so as to define a substantially continuous annular channel that extends circumferentially along the radially outer sidewall portion intermediate the first rim portion and second rim portion.

2. The apparatus of claim 1, further comprising a covering of a substantially biocompatible material that covers at least the radially outer sidewall portion of the apparatus.

3. The apparatus of claim 2, wherein the covering completely covers the base portion, the first rim portion and the second rim portion.

4. The apparatus of claim 2, wherein the covering extends over the radially outer sidewall portion to provide a circumferentially extending chamber defined by the covering, the first rim portion, the second rim portion, and the radially outer sidewall portion intermediate the first and second rim portions.

5. The apparatus of claim 4, wherein the first and second rim portions are monolithic with the base portion and extend outwardly relative to the radially outer sidewall portion intermediate the first and second rim portions a distance that is sufficient to permit a surgical needle to take bites into the covering that overlies the channel.

6. The apparatus of claim 2, further comprising a flange of a substantially flexible and biocompatible material that extends radially outwardly from the base portion at location that is spaced axially apart from at least a portion of the channel.

7. The apparatus of claim 6, wherein the flange comprises at least one annular sheet of a substantially biocompatible material having an inner periphery that is attached to the covering adjacent one of the first and second rim portions.

8. The apparatus of claim 2, wherein the covering comprises a biological tissue material.

9. The apparatus of claim 1, further comprising a buttress member that extends substantially axially from the base portion over a portion of the opening, the buttress member having a radially inner surface that is dimensioned and configured to simulate the dimensions and configuration of at least one heart valve leaflet at a closed position.

10. The apparatus of claim 9, further comprising a covering of a substantially biocompatible material that covers at least the radially outer sidewall portion of the apparatus and surfaces of the buttress member.

11. The apparatus of claim 10, further comprising a flange of a substantially flexible and biocompatible material that extends radially outwardly and circumferentially from the base portion at a location that is spaced axially apart from at least a portion of the channel.

12. The apparatus of claim 1, further comprising a heart valve mounted within the opening of the base portion, the heart valve including at least one moveable member configured to permit substantially unidirectional flow of blood there through.

13. The apparatus of claim 12, further comprising a covering of a substantially biocompatible material that covers at least the radially outer sidewall portion of the apparatus and radially outer exposed surfaces of the heart valve.

14. The apparatus of claim 12, further comprising a flange of a substantially flexible and biocompatible material that extends radially outwardly and circumferentially from the base portion at a location that is spaced axially apart from at least a portion of the channel.

15. The apparatus of claim 14, wherein the radially inner sidewall portion extends axially between opposed inflow and outflow ends of the base portion, the flange extending radially outwardly from the base portion at an axial position adjacent one of inflow and outflow ends of the base portion.

16. The apparatus of claim 12, wherein the base portion is a base portion of a stent, the stent further comprising a plurality of stent posts that extend axially from an outflow end of the base portion, the heart valve comprising a natural tissue heart valve having commissures between adjacent pairs of leaflets, each of the commissures being substantially radially aligned with respective stent posts.

17. The apparatus of claim 16, further comprising a covering of a substantially biocompatible material that covers at least the radially outer sidewall portion of the apparatus and at least radially outer surfaces of the stent, the covering extending over the radially outer sidewall portion of the base portion to provide a circumferentially extending chamber defined by the covering, the first and second rim portions, and the radially outer sidewall portion intermediate the first and second rim portions.

18. The apparatus of claim 1, wherein each of the radially outer sidewall portion and the radially inner sidewall portion extends between axially opposed first and second end surface portions of the base portion, the first rim portion being defined, in part, by a radially outward extension of the first end surface portion, the second rim portion being defined, in part, by a radially outward extension of the second end surface portion.

19. The apparatus of claim 1, further comprising one of:

a buttress member that extends substantially axially from the base portion, the buttress member having a radially inner surface that is dimensioned and configured to simulate the dimensions and configuration of at least one heart valve leaflet at a closed position;

or

a heart valve mounted within the base portion, the heart valve including at least one moveable member configured to permit substantially unidirectional flow of blood there through the base portion and the heart valve.

20. A cardiac prosthesis comprising:

an annular base portion having inflow and outflow end portions spaced apart by a substantially annular sidewall portion that is configured to maintain a circumferential length thereof, an aperture extending axially through the base portion;

a flexible covering of a substantially biocompatible material that connected over at least a radially outer surface of the sidewall portion; and

at least one feature that extends circumferentially around the sidewall portion and covered by the covering to form at least one corresponding chamber that is defined by the covering, the at least one feature and a portion the radially outer surface of the base portion.

21. The prosthesis of claim 20, wherein the at least one feature comprises a channel extending circumferentially in the sidewall portion of the base portion, the covering extending over the channel to define the chamber.

22. The prosthesis of claim 21, further comprising:

a first rim portion extending substantially radially outwardly from the radially outer surface of the sidewall portion; and

a second rim portion extending substantially radially outwardly from the radially outer surface of the portion at an axial location that is axially spaced apart from the first rim portion so as to define the channel intermediate the first rim portion and the second rim portion.

23. The prosthesis of claim 20, wherein the at least one feature is monolithic with the base portion.

24. The prosthesis of claim 20, further comprising a flange of a substantially flexible and biocompatible material that extends radially outwardly from the base portion adjacent one of the inflow or outflow end portions.

25. The prosthesis of claim 24, wherein the flange comprises at least one annular sheet of a substantially biocompatible material having an inner periphery that is attached to the covering adjacent one of the inflow or outflow end portions.

26. The prosthesis of claim 25, wherein the covering and the flange comprise a biological tissue material.

27. The prosthesis of claim 20, further comprising a buttress member that extends substantially axially from the base portion over a portion of the opening, the buttress member having a radially inner surface that is dimensioned and configured to simulate the dimensions and configuration of at least one heart valve leaflet at a closed position, the covering covers surfaces of the buttress member.

28. The prosthesis of claim 27, further comprising a flange of a substantially flexible and biocompatible material that extends radially outwardly and circumferentially from the base portion at a location that is adjacent one of the inflow or outflow end portions.

29. The prosthesis of claim 20, further comprising a heart valve mounted within the base portion, the heart valve including at least one moveable member configured to permit substantially unidirectional flow of blood there through, the covering covers at least radially outer exposed surfaces of the heart valve.

30. The prosthesis of claim 29, further comprising a flange of a substantially flexible and biocompatible material that extends radially outwardly and circumferentially from the base portion at a location that is adjacent one of the inflow or outflow end portions.

31. The prosthesis of claim 29, wherein the heart valve is one of a natural tissue heart valve, a mechanical heart valve, and a biomechanical heart valve.

32. The prosthesis of claim 29, wherein the base portion is a base portion of a stent, the stent further comprising a plurality of stent posts that extend axially from an outflow end of the base portion, the heart valve comprising a natural tissue heart valve having commissures between adjacent pairs of leaflets, each of the commissures being substantially radially aligned with respective stent posts.