Heart valve prosthesis

• US 7,578,843 B2
• Filed: 04/01/2003
• Issued: 08/25/2009
• Est. Priority Date: 07/16/2002
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Shu, Mark C. S.
• Primary Examiner(s): Stewart; Alvin J
• Application Number:
  US10/404,233
• Publication Number:
  US 20040030381A1
• Time in Patent Office: 2,338 Days
• Field of Search: 623 21- 235, 623 236- 242
• 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

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;

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

wherein the split portion includes two split ends defining a split extending through a radial width of the band;

wherein the split ends are spreadable relative to one another and are secured by a restraint mechanism; and

wherein the restraint mechanism includes a suture.

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

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

4. A heart valve prosthesis comprising:

an annular valve body comprising a frame and a suturing ring, the frame forming a central passage defining a longitudinal axis and including at least one outwardly extending annular flange longitudinally spaced from to the suturing ring relative to the longitudinal axis;

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 split portion on the band adapted to lock the band in engagement with the flange of the frame;

wherein the band includes a plurality of splits that extend partially through the band; and

wherein the plurality of splits define at least one locking tab on the band.

5. The heart valve prosthesis of claim 4 wherein the band includes at least two locking tabs.

6. The heart valve prosthesis of claim 4 wherein the locking tab includes at least one barbed portion.

7. The heart valve prosthesis of claim 6 wherein the barbed portion is capable of engaging a portion of the flange of the frame on an inflow portion of the flange.

8. The heart valve prosthesis of claim 4, wherein the annular valve body extends between a suture ring side and a second side opposite the suture ring side, and further wherein the suturing ring is provided at the suture ring side and the annular flange of the frame is located longitudinally between the suturing ring and the second side.

9. 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 of the band 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 upon insertion of the locking element into a complimentary structure provided with an other of the band or the flange of the frame, wherein the locking element includes at least one locking tab.

10. The heart valve prosthesis of claim 9 wherein the prosthesis is a tissue valve.

11. The heart valve prosthesis of claim 9 wherein the frame is a stent.

12. The heart valve prosthesis of claim 9 wherein the locking tab is on the band.

13. The heart valve prosthesis of claim 9 wherein the locking tab is on a flange of the frame.

14. The heart valve prosthesis of claim 9 wherein the locking element includes at least two locking tabs.

15. The heart valve prosthesis of claim 9 wherein the locking tab includes at least one barbed portion.

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

17. The heart valve prosthesis of claim 9 wherein the prosthesis is a mechanical valve.

18. The heart valve prosthesis of claim 9, wherein the annular flange of the frame is longitudinally spaced from the suturing ring.

19. 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;

at least one locking tab formed by one of the band or the flange of the frame adapted to lock the band in engagement with the flange of the frame; and

wherein the prosthesis includes at least two locking tabs.

20. 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;

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; and

wherein the locking tab includes at least one barbed portion extending from a tab portion, the barbed portion having a flat surface having a longitudinal axis projecting perpendicular to the tab portion.

21. The heart valve prosthesis of claim 20 wherein the barbed portion is capable of engaging a portion of the flange of the frame on an inflow portion of the flange.

22. 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 an outside portion and at least one inwardly extending annular flange that define a recess within which the annular flange of the frame is nested upon final assembly, 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;

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; and

wherein the prosthesis is a mechanical valve.