Two piece prosthetic heart valve

• US 6,176,877 B1
• Filed: 04/20/1998
• Issued: 01/23/2001
• Est. Priority Date: 04/20/1998
• Status: Expired due to Term

• Current Assignee: St Jude Medical Incorporated (Abbott Laboratories)
• Original Assignee: St Jude Medical Incorporated (Abbott Laboratories)
• Inventors: Girard, Michael J., Anderson, Kimberly A., Buchanan, Eric S., Holmberg, William R., Allan, Bob
• Primary Examiner(s): Willse, David H.
• Application Number:
  US09/062,822
• Time in Patent Office: 1,009 Days
• Field of Search: 623/2, 623/900, 623/2.38, 623/2.39, 623/2.4, 623/2.41
• US Class Current: 623/2.39
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/072 for applying a row of staples in a single action , e.g. the staples being applied simultaneously
• CPC Class Codes: A61B 17/1155 Circular staplers comprising a plurality of staples
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61B 2017/07214 Stapler heads
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2250/006 modular

Abstract

A prosthetic heart valve for implantation in a heart includes an outer orifice ring for coupling to a tissue annulus of a heart. An inner orifice ring includes at least one leaflet occluder carried in a lumen of the inner orifice ring which is movable between an open position, which allows blood flow through the lumen, and a closed position which blocks blood flow through the lumen. The inner orifice ring is adapted to be coupled to the outer orifice ring after the outer orifice ring has been attached to the tissue annulus.

Claims

1. A prosthetic heart valve for implantation in a heart, comprising:

an outer orifice ring;

an attachment mechanism comprising at least one helical screw on the outer orifice ring adapted to couple the outer orifice ring to a tissue annulus of the heart;

an inner orifice ring having an occluding mechanism carried therein; and

a ring coupling mechanism adapted to couple the outer orifice ring to the inner orifice ring after the outer orifice ring has been coupled to the tissue annulus.

2. The prosthetic heart valve of claim 1 including a plurality of helical screws substantially evenly placed around a circumference of the outer orifice ring.

3. The prosthetic heart valve of claim 1 wherein the ring coupling mechanism comprises a locking ridge formed on a circumference of one of the rings and a locking recess formed on a circumference of the other of the rings, wherein the locking ridge snap fits in the locking recess to thereby secure the two rings together.

4. The prosthetic heart valve of claim 3 wherein the locking ridge extends around an inner circumference of the outer orifice ring and the locking recess extends around an outer circumference of the inner orifice ring.

5. The prosthetic heart valve of claim 1 wherein the occluding mechanism comprises a pair of moveable leaflets pivotably carried in a lumen through the inner orifice ring, the leaflets being moveable between an open position allowing blood flow therethrough and a closed position blocking blood flow therethrough.

6. The prosthetic heart valve of claim 1 wherein the at least one helical screw comprises a cobalt-nickel-chromium-molybdenum alloy.

7. The prosthetic heart valve of claim 1 wherein the inner orifice ring secures the attachment mechanism and shields the outer orifice ring and the attachment mechanism from blood flow when the inner orifice ring is coupled to the outer orifice ring.

8. The prosthetic heart valve of claim 1 wherein the ring coupling mechanism allows limited rotational movement about an axis of the inner orifice ring relative to an axis of the outer orifice ring.

9. The prosthetic heart valve of claim 1 including a seal between the outer orifice ring and the inner orifice ring to provide a fluidic seal therebetween.

10. A prosthetic heart valve for implantation in a heart, comprising:

an outer orifice ring including a plurality of preformed holes formed therein and arranged around the ring to define suture locations, the holes extending in a direction which is generally perpendicular to an axis of the outer orifice ring;

an attachment mechanism comprising a suture on the outer orifice ring, the suture shaped to extend through the holes in the outer orifice ring and couple the outer orifice ring to a tissue annulus of the heart;

an inner orifice ring having an occluding mechanism carried therein; and

a ring coupling mechanism configured to couple the outer orifice ring to the inner orifice ring after the outer orifice ring has been coupled to the tissue annulus.

11. The prosthetic heart valve of claim 10 wherein the ring coupling mechanism comprises a locking ridge formed on a circumference of one of the rings and a locking recess formed on a circumference of the other of the rings, wherein the locking ridge snap fits in the locking recess to thereby secure the two rings together.

12. The prosthetic heart valve of claim 11 wherein the locking ridge extends around an inner circumference of the outer orifice ring and the locking recess extends around an outer circumference of the inner orifice ring.

13. The prosthetic heart valve of claim 10 wherein the occluding mechanism comprises a pair of moveable leaflets pivotably carried in a lumen through the inner orifice ring, the leaflets being moveable between an open position allowing blood flow therethrough and a closed position blocking blood flow therethrough.

14. The prosthetic heart valve of claim 10 wherein the inner orifice ring shields the outer orifice ring attachment mechanism from blood flow when the inner orifice ring is coupled to the outer orifice ring.

15. The prosthetic heart valve of claim 10 wherein the ring coupling mechanism allows limited rotational movement about an axis of the inner orifice ring relative to an axis of the outer orifice ring.

16. The prosthetic heart valve of claim 10 wherein the outer orifice ring includes a recess formed on an inner annulus, the recess adapted to cover the suture.

17. The prosthetic heart valve of claim 10 including a suture cuff carried on an outer annulus of the outer orifice ring and wherein the suture is adapted to extend through the suture cuff.

18. The prosthetic heart valve of claim 10 including a seal between the outer orifice ring and the inner orifice ring to provide a fluidic seal therebetween.

19. A prosthetic heart valve for implantation in a heart, comprising:

an outer orifice ring including a plurality of preformed holes arranged around the ring to define suture or screw locations;

an attachment mechanism on the outer orifice ring adapted to couple the outer orifice ring to a tissue annulus of the heart;

an inner orifice ring having an occluding mechanism carried therein;

a ring coupling mechanism configured to couple the outer orifice ring to the inner orifice ring after the outer orifice ring has been coupled to the tissue annulus; and

wherein the ring coupling mechanism comprises a locking ridge formed on a circumference of one of the rings and a locking recess formed on a circumference of the other of the rings, wherein the locking ridge snap fits in the locking recess to thereby secure the two rings together, the locking recess configured to cover the attachment mechanism.

20. The prosthetic heart valve of claim 19 wherein the attachment mechanism comprises at least one helical screw.

21. The prosthetic heart valve of claim 20 including a plurality of helical screws substantially evenly placed around a circumference of the outer orifice ring.

22. The prosthetic heart valve of claim 20 wherein the at least one helical screw comprises platinum-iridium.

23. The prosthetic heart valve of claim 19 wherein the locking ridge extends around an inner circumference of the outer orifice ring and the locking recess extends around an outer circumference of the inner orifice ring.

24. The prosthetic heart valve of claim 19 wherein the occluding mechanism comprises a pair of moveable leaflets pivotably carried in a lumen through the inner orifice ring, the leaflets being moveable between an open position allowing blood flow therethrough and a closed position blocking blood flow therethrough.

25. The prosthetic heart valve of claim 19 wherein the inner orifice ring secures the attachment mechanism and shields the outer orifice ring attachment mechanism from blood flow when the inner orifice ring is coupled to the outer orifice ring.

26. The prosthetic heart valve of claim 19 wherein the ring coupling mechanism allows limited rotational movement about an axis of the inner orifice ring relative to an axis of the outer orifice ring.

27. The prosthetic heart valve of claim 19 wherein the attachment mechanism comprises a suture.

28. The prosthetic heart valve of claim 27 including a suture cuff carried on an outer annulus of the outer orifice ring and wherein the suture is adapted to extend through the suture cuff.

29. The prosthetic heart valve of claim 27 wherein the outer orifice ring includes a recess formed on an inner annulus, the recess adapted to receive the suture.

30. The prosthetic heart valve of claim 27 including a seal between the outer orifice and the inner orifice ring to provide a fluidic seal therebetween.