Extra-anatomic heart valve apparatus

• US 6,090,140 A
• Filed: 02/17/1999
• Issued: 07/18/2000
• Est. Priority Date: 02/17/1999
• Status: Expired due to Fees

• Current Assignee: Shlomo Gabbay
• Original Assignee: Shelhigh, Inc.
• Inventors: Gabbay, Shlomo
• Primary Examiner(s): Milano, Michael J.
• Application Number:
  US09/251,968
• Time in Patent Office: 517 Days
• Field of Search: 623/2.1, 623/2.12, 623/2.2, 623/3.1, 623/3.26, 623/3.3
• US Class Current: 623/2.1
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1135 End-to-side connections, e.g. T- or Y-connections
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• 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

Abstract

An extra-anatomic heart valve apparatus, which may be mounted externally to the heart, includes a heart valve positioned within a generally tubular conduit. An elongated outflow conduit extends from the tubular conduit and terminates in an end spaced from the heart valve. A resilient support and/or corrugations may be added to the outflow conduit to help resist compression of the conduit as well as to facilitate bending thereof.

Claims

1. An extra-anatomic heart valve apparatus comprising:

a heart valve having an inflow end, an outflow end and a central axis extending through the inflow and outflow ends;

a substantially flexible stent element disposed substantially coaxially about said heart valve intermediate the inflow and outflow ends of said heart valve;

an elongated outflow conduit extending longitudinally from the outflow end of said heart valve and terminating in a distal end spaced from said heart valve;

at least one resilient support disposed about said outflow conduit intermediate the outflow end of said heart valve and the distal end of said outflow conduit; and

an outer sheath of biological material connected with said outflow conduit and covering said a least one resilient support.

2. An apparatus as set forth in claim 1 wherein said outflow conduit has a sidewall formed of biological material.

3. An apparatus as set forth in claim 1 further comprising a sheath of biological material mounted coaxially around said heart valve and said flexible stent element to define a substantially cylindrical sidewall portion around said heart valve, said sheath having a first end portion connected at the inflow end of said heart valve and a second end portion spaced axially from the first end portion adjacent the outflow end of said heart valve, the second end portion of said sheath being connected with said outflow conduit.

4. An apparatus as set forth in claim 3 wherein said heart valve is formed of a pulmonic heart valve.

5. An apparatus as set forth in claim 4 wherein at least part of said outflow conduit is formed of a pulmonary artery which also forms the outer sidewall portion of said pulmonic heart valve.

6. An apparatus as set forth in claim 5 wherein said resilient support includes a plurality of rings connected about said pulmonary artery in an axially spaced apart relationship.

7. An apparatus as set forth in claim 1 wherein said outflow conduit further includes a plurality of circumferentially extending corrugations intermediate the outflow end of said heart valve and the distal end of said outflow conduit.

8. An apparatus as set forth in claim 7 wherein said outflow conduit has a generally cylindrical sidewall formed of a biological material, said corrugations being formed in the cylindrical sidewall of said outflow conduit.

9. An apparatus as set forth in claim 7 further including a generally rigid, tubular implantation member extending longitudinally from the distal end of said outflow conduit, said implantation member having a sidewall portion which terminates in a first end spaced from the distal end of said outflow conduit, said implantation members also having an implantation flange extending outwardly from the sidewall portion of said implantation member spaced from the first end of said implantation member.

10. An apparatus as set forth in claim 9 further including a substantially planar annular ring having an inner diameter which is greater than an outer diameter of said implantation flange, said annular ring being connectable with and circumscribing said implantation flange through sutures.

11. An apparatus as set forth in claim 1 further including an elongated inflow conduit extending longitudinally from the inflow end of said heart valve, said inflow conduit having a first end connected adjacent the inflow end of said heart valve and terminating in a second end spaced from the inflow end of said heart valve.

12. An apparatus as set forth in claim 11 wherein said inflow conduit further includes a cylindrical sidewall having a plurality of circumferentially extending corrugations formed in the sidewall of said inflow conduit.

13. An apparatus as set forth in claim 12 further including at least one resilient support disposed circumferentially about said inflow conduit between the inflow end of said heart valve and the second end of said inflow conduit.

14. An apparatus as set forth in claim 13 wherein said at least one resilient support further includes a plurality of substantially flexible annular rings disposed circumferentially about said outflow conduit between the outflow end of said heart valve and the distal end of said outflow conduit, said plurality of annular rings being in an axially spaced apart relationship.

15. An apparatus as set forth in claim 14 further including biological material mounted to said outflow conduit to cover each of said plurality of flexible rings.

16. An extra-anatomic heart valve apparatus comprising:

a first conduit portion having a substantially cylindrical sidewall with first and second spaced apart ends;

a heart valve having inflow and outflow ends mounted within said first conduit portion between the respective first and second ends of said first conduit portion;

an elongated second conduit portion extending longitudinally from the second end of said first conduit portion, said second conduit portion having a substantially cylindrical sidewall with a first end connected at the second end of said first conduit portion and terminating in a second end spaced apart from the first end of said second conduit portion; and

a plurality of circumferentially extending corrugations formed in the sidewall of said second conduit portion.

17. An apparatus as set forth in claim 16 further including at least one resilient support circumferentially disposed about said second conduit portion and a biological material connected with said second conduit portion covering said at least one resilient support.

18. An apparatus as set forth in claim 17 wherein said at least one resilient support further includes a plurality of substantially flexible rings disposed about said second conduit portion, each of said rings being in an axially spaced apart relationship along said second conduit portion between the first and second ends of the second conduit portion.

19. An apparatus as set forth in claim 16 further including a third conduit portion extending longitudinally from the inflow end of said first conduit portion.

20. An apparatus as set forth in claim 19 wherein said third conduit further includes a substantially flexible elongated sidewall having a plurality of circumferentially extending corrugations formed in the sidewall of said third conduit.

21. An apparatus as set forth in claim 16 further including a generally rigid and tubular implantation member connected to and extending from the second end of said second conduit portion, said implantation member having a cylindrical outer sidewall and an implantation flange extending outwardly from the outer sidewall of said implantation member adjacent the second end of said second conduit portion.

22. An apparatus as set forth in claim 18 wherein said implantation flange of said implantation member has an outer diameter and said apparatus further includes an annular pledget having a central bore with an inner diameter that is greater than the outer diameter of said implantation flange, said annular pledget being connectable to and circumscribing said implantation flange through sutures.

23. An apparatus as set forth in claim 16 wherein said flexible stent element has inflow and outflow ends contoured according to the contour of the inflow and outflow ends of said heart valve, the inflow and outflow ends of said flexible stent element being spaced axially from the inflow and outflow ends of said heart valve.

24. An extra-anatomic heart valve apparatus comprising:

a first conduit portion having a cylindrical sidewall with first and second ends;

a heart valve having inflow and outflow ends mounted within said first conduit portion between the first and second ends of said first conduit portion;

an elongated second conduit portion extending longitudinally from said first conduit portion, said second conduit portion having a cylindrical sidewall portion with a first end connected at the second end of said first conduit portion and terminating in a second end spaced apart from the first end of said second conduit;

at least one resilient support circumferentially disposed about said second conduit portion; and

a biological material connected with said second conduit portion covering said at least one resilient support.

25. An apparatus as set forth in claim 24 wherein said at least one resilient support further comprises a plurality of substantially flexible rings disposed about said second conduit portion, said rings being in an axially spaced apart relationship along said outflow conduit;

and

biological material connected with said second conduit portion covering each of said plurality of rings of said second conduit portion.

26. An apparatus as set forth in claim 24 wherein said second conduit portion further includes a cylindrical sidewall formed of biological material having circumferentially extending corrugations formed in the cylindrical sidewall of said second conduit portion intermediate the outflow end of said heart valve and the second end of said second conduit portion.

27. An apparatus as set forth in claim 24 further including an elongated inflow conduit connected to and extending longitudinally from the first end of said first conduit portion, said inflow conduit having a first end adjacent said inflow end of said heart valve and a second end spaced from the inflow end of said heart valve.

28. An extra-anatomic heart valve apparatus comprising:

a heart valve having an inflow end, an outflow end and a central axis extending through the inflow and outflow ends;

a substantially flexible stent element disposed about said heart valve intermediate the inflow and outflow ends of said heart valve;

a generally cylindrical sheath of biological material being mounted coaxially about said valve and said stent element, said sheath having an axial length about equal to or greater than the axial length of said heart valve, said sheath having a first end adjacent said inflow end of said heart valve and a second end adjacent said outflow end of said heart valve;

an elongated, flexible outflow conduit having a sidewall connected to and extending longitudinally from the second end of said sheath and terminating in a distal end spaced from said heart valve, a plurality of circumferentially extending corrugations formed in the sidewall of said outflow conduit;

a generally rigid, tubular implantation member connected to and extending from the distal end of said outflow conduit, said implantation member having an outer sidewall with an implantation flange extending outwardly from the outer sidewall of said implantation member adjacent the second end of said second conduit portion; and

an elongated, flexible inflow conduit connected to and extending longitudinally from the first end of said sheath.

29. An apparatus as set forth in claim 28 further comprising a plurality of resilient support members attached about said outflow conduit in an axially spaced apart relationship, each of said support members being covered with a biological material.