Method for implanting a heart valve within an annulus of a patient

• US 8,460,373 B2
• Filed: 07/01/2011
• Issued: 06/11/2013
• Est. Priority Date: 12/20/2002
• Status: Expired due to Fees

• 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:
  US13/175,206
• Publication Number:
  US 20110257737A1
• Time in Patent Office: 711 Days
• Field of Search: 623/1.26, 623/2.11, 623/2.4, 623/904, 623/910, 623/2.38, 623/2.37
• 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

A method for implanting a heart valve assembly includes a first annular prosthesis for implantation within a tissue annulus, a second valve prosthesis, and a multi-lobed connection adapter to secure the second prosthesis to the first prosthesis. In one embodiment, the adapter is arranged to allow the second prosthesis to be secured to the first prosthesis in a predetermined angular orientation. During use, the first annular prosthesis is implanted into the annulus, and the second valve prosthesis is inserted into the annulus. The adapter secures the second prosthesis relative to the first prosthesis to align the second prosthesis with the first prosthesis in a predetermined angular orientation; and secure the second prosthesis to the first prosthesis in the predetermined angular orientation.

Claims

1. A method for implanting a heart valve in a tissue annulus within a patient'"'"'s heart, comprising:

positioning a first annular prosthesis within the tissue annulus in an unexpanded state, wherein the first annular prosthesis comprises a circular circumference;

expanding the first prosthesis to an expanded state within the tissue annulus to contact surrounding tissue;

fixing the first prosthesis to tissue surrounding the tissue annulus;

introducing a second valve prosthesis into the tissue annulus after fixing the first prosthesis;

introducing a connection adapter into the tissue annulus, the connection adapter including a multi-lobed circumference; and

securing the second prosthesis relative to the first prosthesis within the tissue annulus using the connection adapter.

2. The method of claim 1, wherein the first prosthesis is expanded within the tissue annulus by releasing the first prosthesis such that the first prosthesis resiliently expands within the tissue annulus.

3. The method of claim 1, wherein the first prosthesis is expanded within the tissue annulus using an expansion tool.

4. The method of claim 3, wherein the expansion tool comprises one of a balloon, a clamp, or a flexible plug assembly.

5. The method of claim 1, wherein the first prosthesis comprises an annular ring that is folded in the unexpanded state and wherein the annular ring unfolds to the expanded state.

6. The method of claim 1, wherein the first prosthesis is fixed to tissue by inserting a plurality of fixturing devices through the first prosthesis into tissue surrounding the tissue annulus.

7. The method of claim 6, wherein the first prosthesis comprises fixturing device connectors, and wherein the fixturing devices are pushed through the fixturing device connectors into tissue surrounding the tissue annulus.

8. The method of claim 6, wherein the fixturing devices comprise sutures, clips, staples, or pins.

9. The method of claim 1, wherein securing the second prosthesis comprises snap-fitting the second prosthesis to the first prosthesis.

10. The method of claim 1, wherein securing the second prosthesis comprises engaging a plurality of engagement elements on the first and second prostheses.

11. The method of claim 10, wherein the engagement elements allow the second prosthesis to be secured relative to the first prosthesis only in a predetermined angular orientation about a central axis of the first and second prostheses.

12. The method of claim 1, wherein securing the second prosthesis comprises:

angularly orienting the second prosthesis about a central longitudinal axis of the first and second prostheses relative to the first prosthesis to align the second prosthesis with the first prosthesis in a predetermined angular orientation; and

directing the second prosthesis into engagement with the first prosthesis to secure the second prosthesis in the predetermined angular orientation.

13. The method of claim 1, wherein the second prosthesis comprises a frame having a multiple lobed shape including a latitudinal cross-section in a plane perpendicular to a central longitudinal axis of the second prosthesis defining multiple lobes separated by scallops, and wherein the first prosthesis comprises an annular ring having a circular circumference in the expanded state.

14. The method of claim 13, wherein the second prosthesis is introduced into the tissue annulus with the frame in the multiple lobed shape.

15. The method of claim 14, further comprising angularly orienting the second prosthesis about the central longitudinal axis before securing the second prosthesis.

16. A method for implanting a heart valve in a tissue annulus within a patient'"'"'s heart, comprising:

positioning a first annular prosthesis within the tissue annulus in an unexpanded state, the first prosthesis comprising an annular ring that is folded in the unexpanded state;

expanding the first prosthesis to an expanded state within the tissue annulus wherein the annular ring comprises a surface for contacting tissue;

fixing the first prosthesis to the tissue annulus by introducing a plurality of fixturing devices through the first prosthesis into tissue surrounding the tissue annulus;

introducing a second valve prosthesis into the tissue annulus after fixing the first prosthesis, the second prosthesis comprising a frame having a plurality of leaflets attached to the frame;

introducing a connection adapter into the tissue annulus, the connection adapter having a multi-lobed circumference; and

securing the second prosthesis relative to the first prosthesis within the tissue annulus using the connection adapter.

17. The method of claim 16, wherein the first prosthesis is expanded within the tissue annulus by releasing the first prosthesis such that the annular ring resiliently expands within the tissue annulus.

18. The method of claim 16, wherein the plurality of fixturing devices comprise sutures, clips, staples, or pins.

19. The method of claim 16, wherein securing the second prosthesis comprises snap-fitting the second prosthesis to the first prosthesis.

20. The method of claim 16, wherein securing the second prosthesis comprises engaging a plurality of engagement elements on the first and second prostheses.