Biologically implantable prosthesis and methods of using the same

• US 8,623,080 B2
• Filed: 09/22/2011
• Issued: 01/07/2014
• 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:
  US13/240,426
• Publication Number:
  US 20120053688A1
• Time in Patent Office: 838 Days
• Field of Search: 623/1.24, 623/1.26, 623/2.11, 623/2.14, 623/2.17, 623/2.38, 623/2.39, 623/902, 623/904
• 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 of using a prosthetic heart valve assembly can include implanting a first prosthesis directly into a native annulus. The first prosthesis can have a central longitudinal axis and a first engagement element. The method can also include engaging the first engagement element of the first prosthesis with a second engagement element of a second prosthesis to securely couple the second prosthesis to the first prosthesis. The second prosthesis can have a prosthetic valve. The first engagement element engages the second engagement element by moving the second prosthesis towards the first prosthesis in a direction generally parallel to the central longitudinal axis until the first engagement element engages the second engagement element.

Claims

1. A method of using a prosthetic heart valve assembly, the method comprising:

implanting a first prosthesis directly into a native annulus, the first prosthesis having a central longitudinal axis, a first wall segment, a second wall segment adjacent the first wall segment and angled relative to the longitudinal axis, a first engagement element positioned on the first wall segment, and a second engagement element positioned on the second wall segment; and

engaging the first engagement element of the first prosthesis with a third engagement element of a second prosthesis and engaging the second engagement element with a fourth engagement element of the second prosthesis to securely couple the second prosthesis to the first prosthesis, the second prosthesis having a prosthetic valve,

wherein the first engagement element engages the second engagement element by moving the second prosthesis towards the first prosthesis in a direction generally parallel to the central longitudinal axis until the first engagement element engages the second engagement element.

2. The method of claim 1, wherein the first prosthesis comprises an annular ring having a circular latitudinal cross-section perpendicular to the central longitudinal axis.

3. The method of claim 2, wherein implanting the first prosthesis directly into the native annulus comprises circumferentially expanding a diameter of the first prosthesis such that the first prosthesis frictionally engages the native annulus.

4. The method of claim 1, wherein implanting the first prosthesis directly into the native annulus comprises using fixturing devices to fix the first prosthesis to the native annulus.

5. The method of claim 1, wherein the second prosthesis has a second central longitudinal axis and a latitudinal cross-section in a plane perpendicular to the second central longitudinal axis defining multiple lobes separated by scallops, the scallops being disposed closer to the second central longitudinal axis within the plane than the lobes.

6. The method of claim 1, wherein the first engagement element of the first prosthesis comprises a lip, and wherein the second engagement element of the second prosthesis comprises a locking tab.

7. The method of claim 1, wherein the first and second engagement elements each comprise a magnet.

8. The method of claim 1, wherein the engagement of the first engagement element to the second engagement element comprises snap-fitting the second prosthesis to the first prosthesis.

9. The method of claim 1 further comprising

disengaging the first engagement element of the first prosthesis with the third engagement element of the second prosthesis to uncouple the second prosthesis from the first prosthesis implanted in the native annulus;

and

engaging a fifth engagement element disposed on a third prosthesis with the first engagement element of the first prosthesis to securely couple the third prosthesis to the first prosthesis implanted in the native annulus.

10. The method of claim 9, wherein disengaging the first engagement element with the second engagement element to uncouple the second prosthesis from the first prosthesis comprises deforming the second prosthesis such that the first engagement element disengages the second engagement element.

11. The method of claim 10, wherein deforming the second prosthesis comprises

inserting a lever into a gap between the second prosthesis and the first prosthesis, the gap being defined by a scallop separating two lobes in a latitudinal cross-section in a plane perpendicular to the central longitudinal axis of the first prosthesis, the scallop being disposed closer to the central longitudinal axis within the plane than the two lobes;

and

applying a force to the second prosthesis with the lever to deform the second prosthesis such that the first engagement element disengages the second engagement element.

12. A method of replacing a prosthetic valve comprising:

disengaging a first engagement element of a first prosthesis with a second engagement element of a second prosthesis to uncouple the second prosthesis from the first prosthesis, wherein the first prosthesis is implanted in a native annulus, and wherein the second prosthesis comprises a prosthetic valve;

wherein disengaging the first engagement element with the second engagement element to uncouple the second prosthesis from the first prosthesis comprises deforming the second prosthesis such that the second engagement element disengages the first engagement element;

wherein deforming the second prosthesis comprises inserting a lever into a gap between the second prosthesis and the first prosthesis, the gap being defined by a scallop separating two lobes in a latitudinal cross-section in a plane perpendicular to a central longitudinal axis of the first prosthesis, the scallop being disposed closer to the central longitudinal axis within the plane than the two lobes, and applying a force to the second prosthesis with the lever to deform the second prosthesis such that the second engagement element disengages the first engagement element; and

engaging a third engagement element of a third prosthesis with the first engagement element of the first prosthesis to securely couple the third prosthesis to the first prosthesis, wherein the third prosthesis comprises a prosthetic valve.

13. The method of claim 12, wherein the lever is an arm of a clamp device.

14. The method of claim 12, wherein the first prosthesis comprises an annular ring having a circular latitudinal cross-section perpendicular to a central longitudinal axis of the first prosthesis.

15. The method of claim 12, wherein the first engagement element of the first prosthesis comprises a lip, the second engagement element of the second prosthesis comprises a locking tab, and the third engagement element of the third prosthesis comprises a locking tab.

16. The method of claim 12, wherein the first, second, and third engagement elements each comprise a magnet.

17. The method of claim 12, wherein the first and second engagement elements comprise elements for snap-fitting the second prosthesis to the first prosthesis, and the first and third engagement elements comprise elements for snap-fitting the third prosthesis to the first prosthesis.