Heart valve prosthesis

• US 20040030381A1
• Filed: 04/01/2003
• Published: 02/12/2004
• Est. Priority Date: 07/16/2002
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Shu, Mark C.S.
• Granted Patent: US 7,578,843 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• 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 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• 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
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: A61F 2250/006 modular

Abstract

A heart valve prosthesis has a frame that includes at least one outwardly extending annular flange adjacent to a suturing ring and a band comprising an inwardly extending annular flange that is capable of engagement with the annular flange of the frame. A tortuous path is formed between the annular flange of the frame and the annular flange of the band that can engage and restrain a suture placed between them. One or more split portions or tab portions on the band are adapted to lock the band in engagement with the flange of the frame. Such a device can be used to more easily replace a heart valve by advancing a sutures through a suturing ring on the valve and the valvular rim such that they are brought outward of the flange extending from the frame and then advancing the band over the valve and over the sutures at a proximal, outflow end of the valve until the band engages the flange and captures the sutures between the band and the flange.

Claims

17. A heart valve prosthesis comprising

an annular valve body comprising a frame and a suturing ring, the frame including at least one outwardly extending annular flange adjacent to the suturing ring, the annular flange having at least one recess formed on an upper, outflow side of the flange;

a band comprising at least one inwardly extending annular flange that is capable of engagement with the annular flange of the frame, including a portion of the flange capable of engagement with the at least one recess formed on the annular flange of the frame, such that a tortuous path is formed between the annular flange of the frame and the annular flange of the band that can engage and restrain a suture placed therein; and

at least one locking element on one of the band or the flange of the frame adapted to lock the band in engagement with the flange of the frame.

18. The heart valve prosthesis of claim 17 wherein the prosthesis is a tissue valve.

19. The heart valve prosthesis of claim 17 wherein the frame is a stent.

20. The heart valve prosthesis of claim 17 wherein the locking element includes at least one locking tab.

21. The heart valve prosthesis of claim 20 wherein the locking tab is on the band.

22. The heart valve prosthesis of claim 20 wherein the locking tab is on a flange of the frame.

23. The heart valve prosthesis of claim 20 wherein the locking element includes at least two locking tabs.

24. The heart valve prosthesis of claim 20 wherein the locking tab includes at least one barbed portion.

25. The heart valve prosthesis of claim 24 wherein the barbed portion is capable of engaging a portion of the flange of the frame on an inflow portion of the flange.

26. The heart valve prosthesis of claim 17 wherein the prosthesis is a mechanical valve.

27. A heart valve prosthesis comprising

an annular valve body comprising a frame and a suturing ring, the frame including at least one outwardly extending annular flange adjacent to the suturing ring;

a band comprising at least one inwardly extending annular flange that is capable of engagement with the annular flange of the frame, including a portion of the flange capable of engagement with a portion of the annular flange of the frame, such that a tortuous path is formed between the annular flange of the frame and the annular flange of the band that can engage and restrain a suture placed therein; and

at least one locking tab on one of the band or the flange of the frame adapted to lock the band in engagement with the flange of the frame.

28. The heart valve prosthesis of claim 27 wherein the prosthesis is a tissue valve.

29. The heart valve prosthesis of claim 27 wherein the frame is a stent.

30. The heart valve prosthesis of claim 27 wherein the locking tab is on the band.

31. The heart valve prosthesis of claim 27 wherein the locking tab is on a flange of the frame.

32. The heart valve prosthesis of claim 27 wherein the prosthesis includes at least two locking tabs.

33. The heart valve prosthesis of claim 27 wherein the locking tab includes at least one barbed portion.

34. The heart valve prosthesis of claim 33 wherein the barbed portion is capable of engaging a portion of the flange of the frame on an inflow portion of the flange.

35. The heart valve prosthesis of claim 27 wherein the prosthesis is a mechanical valve.

36. A heart valve prosthesis comprising

an annular valve body comprising a frame and a suturing ring, the frame including at least one outwardly extending annular flange adjacent to the suturing ring;

a band comprising at least one inwardly extending annular flange that is capable of engagement with the annular flange of the frame, such that a tortuous path is formed between the annular flange of the frame and the annular flange of the band that can engage and restrain a suture placed therein; and

at least one locking element on the band adapted to lock the band in engagement with an inflow side of the flange of the frame.

1. A heart valve prosthesis comprising

an annular valve body comprising a frame and a suturing ring, the frame including at least one outwardly extending annular flange adjacent to the suturing ring;

a band comprising at least one inwardly extending annular flange that is capable of engagement with the annular flange of the frame such that a tortuous path is formed between the annular flange of the frame and the annular flange of the band that can engage and restrain a suture placed therein; and

at least one split portion on the band adapted to lock the band in engagement with the flange of the frame.

2. The heart valve prosthesis of claim 1 wherein the prosthesis is a tissue valve.

3. The heart valve prosthesis of claim 1 wherein the frame is a stent.

4. The heart valve prosthesis of claim 1 wherein the frame has at least two annular flanges.

5. The heart valve prosthesis of claim 4 wherein the band has at least three annular flanges.

6. The heart valve prosthesis of claim 1 wherein the split portion includes two split ends.

7. The heart valve prosthesis of claim 6 wherein the split ends are secured by a restraint mechanism.

8. The heart valve prosthesis of claim 7 wherein the restraint mechanism includes a resilient material.

9. The heart valve prosthesis of claim 8 wherein the resilient material is nitinol.

10. The heart valve prosthesis of claim 7 wherein the restraint mechanism includes a suture.

11. The heart valve prosthesis of claim 1 wherein the band includes a plurality of splits that extend partially through the band.

12. The heart valve prosthesis of claim 11 wherein the plurality of splits define at least one locking tab on the band.

13. The heart valve prosthesis of claim 12 wherein the band includes at least two locking tabs.

14. The heart valve prosthesis of claim 12 wherein the locking tab includes at least one barbed portion.

15. The heart valve prosthesis of claim 14 wherein the barbed portion is capable of engaging a portion of the flange of the frame on an inflow portion of the flange.

16. The heart valve prosthesis of claim 1 wherein the prosthesis is a mechanical valve.

37. The heart valve prosthesis of claim 36 wherein the prosthesis is a tissue valve.

38. The heart valve prosthesis of claim 37 wherein the frame is a stent.

39. The heart valve prosthesis of claim 36 wherein the locking element includes at least one locking tab.

40. The heart valve prosthesis of claim 39 wherein the locking element includes at least two locking tabs.

41. The heart valve prosthesis of claim 39 wherein the locking tab includes at least one barbed portion.

42. The heart valve prosthesis of claim 36 wherein the prosthesis is a mechanical valve.

46. The method of claim 36 further comprising applying a tool having a portion adapted to mate with a portion of the band to the band as it the band is advanced into engagement with the flange.

37-1. The method of claim 36 further comprising locking the band to the flange.

43. A system for replacement of a heart valve comprising:

A heart valve prosthesis comprising an annular valve body having a frame and a suturing ring, the frame including at least one outwardly extending annular flange adjacent to the suturing ring;

a band comprising at least one inwardly extending annular flange that is capable of engagement with the annular flange of the frame, such that a tortuous path is formed between the annular flange of the frame and the annular flange of the band that can engage and restrain a suture placed therein;

at least one locking element adapted to lock the band in engagement with the flange of the frame;

a valve holder affixed to the heart valve prosthesis;

a handle extending from the valve holder; and

a tool having a portion adapted for mating with a portion of the band and adapted to be advanced over the handle and over the valve holder to apply the band in mating engagement with the flange of the frame.

44. The system of claim 43 further comprising a suture tensioning tool mounted on the handle.

45. A method for replacing a heart valve comprising:

advancing a heart valve prosthesis having an annular valve body having a frame and a suturing ring into position on a prepared valvular rim, advancing a plurality of sutures through the suturing ring and the valvular rim and outward of a flange extending from the frame;

advancing a band over the valve and over the sutures at a proximal, outflow end of the valve until the band engages the flange, thereby capturing the sutures between the band and the flange.