Biologically implantable prosthesis

• US 8,551,162 B2
• Filed: 12/20/2002
• Issued: 10/08/2013
• Est. Priority Date: 12/20/2002
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Fogarty, Thomas J., Drews, Michael J., Holmgren, Neil, Modesitt, D. Bruce
• Primary Examiner(s): PREBILIC, PAUL B
• Application Number:
  US10/327,821
• Publication Number:
  US 20040122516A1
• Time in Patent Office: 3,945 Days
• Field of Search: 623/2.11, 623/1.17, 623/1.24, 623/1.26, 623/2.38, 623/2.39, 623/2.4, 623/2.41
• US Class Current: 623/2.38
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/0608 J-shaped
• 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 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2002/30545 for adjusting a diameter
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0041 using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2220/0066 stapled
• 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: Y10S 623/91 Heart

Abstract

Biologically implantable prostheses and methods of using the same are disclosed. In one embodiment, a heart valve assembly includes a first annular prosthesis sized for introduction into a tissue annulus in a heart; a first magnet in the first prosthesis; a second valve prosthesis separate and disconnected from the first prosthesis and comprising a heart valve crown with leaflets, the second prosthesis configured for introduction into the tissue annulus after introducing the first prosthesis into the tissue annulus; and a second magnet in the second prosthesis, wherein an attraction between the first magnet and the second magnet engages the first prosthesis to the second prosthesis to attach the second prosthesis to the first prosthesis in the tissue annulus.

Claims

1. A heart valve assembly comprising:

a first annular prosthesis configured to be implanted into a tissue annulus in a heart such that the first prosthesis includes a circular wall having an inner surface and an outer surface;

wherein the outer surface is configured to abut the tissue annulus;

a first magnet in the first prosthesis;

a second valve prosthesis separate and disconnected from the first prosthesis and comprising a heart valve crown with leaflets, the second prosthesis configured for introduction into the tissue annulus after introducing the first prosthesis into the tissue annulus; and

a second magnet in the second prosthesis, wherein an attraction between the first magnet and the second magnet engages the first prosthesis to the second prosthesis to attach the second prosthesis to the inner surface of the first prosthesis in the tissue annulus.

2. The heart valve assembly of claim 1, wherein the wall of the first prosthesis is circumferentially expandable.

3. The heart valve assembly of claim 2, wherein the wall comprises overlapping edges, the edges being movable relative to one another to allow expansion of the wall.

4. The heart valve assembly of claim 1, wherein the first and second prostheses comprise a plurality of magnets distributed about circumferences of the first and second prostheses.

5. The heart valve assembly of claim 4, wherein the plurality of magnets are arranged to allow the second prosthesis to be engaged with the first prosthesis in one angular orientation.

6. The heart valve assembly of claim 1, wherein the first prosthesis comprises a plurality of receiving elements, the heart valve assembly further comprising a plurality of fixturing devices receivable through the receiving elements for securing the first prosthesis to tissue surrounding an annulus within which the first prosthesis is to be secured.

7. The heart valve assembly of claim 6, wherein the fixturing devices comprise clips.

8. The heart valve assembly of claim 1, wherein the circular wall of the first prosthesis is disposed around a longitudinal axis, and wherein at least a portion of the wall has a longitudinal cross-section that is angled relative to the longitudinal axis.

9. The heart valve assembly of claim 8, wherein a first segment of the wall is angled at a first angle relative to the longitudinal axis, and a second segment of the wall is angled at a second angle relative to the longitudinal axis.

10. The heart valve assembly of claim 9, wherein the first and second segments define a joint angle therebetween.

11. The heart valve assembly of claim 10, wherein the joint angle is between about 90°

and about 180°

.

12. The heart valve assembly of claim 1, wherein the circular wall of the first prosthesis is disposed around a longitudinal axis, and wherein the wall comprises first and second ends disposed adjacent one another, the first and second ends being movable relative to one another for expanding the circumference of the wall.

13. The heart valve assembly of claim 12, wherein the first prosthesis comprises an open form.

15. The heart valve assembly of claim 1, wherein the circular wall includes a fabric covering.

16. The heart valve assembly of claim 1, wherein the second prosthesis comprises three lobes.

17. The heart valve assembly of claim 1, wherein at least one of the first and second prostheses includes elements for angularly orienting the second prosthesis relative to the first prosthesis.

18. The heart valve assembly of claim 17, wherein the elements comprise a steering groove in the wall of the first prosthesis.

19. The heart valve assembly of claim 18, wherein the elements further comprise a rib on the second prosthesis that fits in the groove.

20. The heart valve assembly of claim 1, wherein the magnets are encapsulated in a coating.

21. The heart valve assembly of claim 20, wherein the coating comprises PTFE, PEEK, or a combination thereof.

22. The heart valve assembly of claim 1, wherein the magnets comprise a radiopaque material.

23. The heart valve assembly of claim 2, wherein the first prosthesis is resiliently circumferentially expandable for engaging the tissue annulus.

24. The heart valve assembly of claim 2, wherein the first prosthesis is expandable from an unexpanded state to an expanded state.

25. The heart valve assembly of claim 24, wherein the first prosthesis has a smooth wall in the unexpanded state.

26. The heart valve assembly of claim 2, wherein the first prosthesis comprises a cloth sewing surface extending radially outwardly away from the wall.

27. The heart valve assembly of claim 2, wherein the wall comprises first and second ends that overlap one another.

28. The heart valve assembly of claim 27, wherein the first end comprises one or more protrusions, and wherein the second end comprises one or more receiving elements for receiving the one or more protrusions for limiting movement of the first and second ends relative to one another.

29. The heart valve assembly of claim 28, wherein the one or more protrusions and one or more receiving elements prevent the wall from circumferentially expanding beyond a desired limit.

30. The heart valve assembly of claim 28, wherein the one or more protrusions and one or more receiving elements prevent the wall from circumferentially decreasing beyond a desired limit.

31. The heart valve assembly of claim 27, wherein the first and second ends comprise one or more cooperating connectors for limiting movement of the first and second ends relative to one another.

14. A heart valve assembly comprising:

a first annular prosthesis sized for introduction into a tissue annulus in a heart, wherein the first prosthesis is covered with a fabric;

a first magnet in the first prosthesis;

a second valve prosthesis separate and disconnected from the first prosthesis and comprising a heart valve crown with leaflets, the second prosthesis configured for introduction into the tissue annulus after introducing the first prosthesis into the tissue annulus; and

a second magnet in the second prosthesis, wherein an attraction between the first magnet and the second magnet engages the first prosthesis to the second prosthesis to attach the second prosthesis to the first prosthesis in the tissue annulus.