Replacement prosthetic heart valve, system and method of implant

• US 20060052867A1
• Filed: 09/07/2004
• Published: 03/09/2006
• Est. Priority Date: 09/07/2004
• Status: Abandoned Application

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Ryan, Timothy R., Lemmon, Jack D., Revuelta, Jose M.
• Application Number:
  US10/935,730
• Publication Number:
  US 20060052867A1
• Time in Patent Office: Days
• US Class Current: 623/2.180
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts

Abstract

A method of functionally replacing a previously implanted prosthetic heart valve. The method includes positioning a replacement prosthetic heart valve within an internal region defined by the previously implanted prosthetic heart valve. The replacement prosthetic heart valve is then physically docked to the previously implanted prosthetic heart valve. With this technique, the previously implanted prosthetic heart valve serves as a platform for securement of the replacement prosthetic heart valve to the patient'"'"'s native tissue.

Claims

1. A method of functionally replacing a previously implanted prosthetic heart valve, the method comprising:

positioning a replacement prosthetic heart valve within an internal region defined by the previously implanted prosthetic heart valve; and

physically docking the replacement prosthetic heart valve to the previously implanted prosthetic heart valve.

2. The method of claim 1, wherein following fastening, the replacement prosthetic heart valve is anchored relative to native bodily tissue via the previously implanted prosthetic heart valve.

3. The method of claim 1, wherein physically docking the replacement prosthetic heart valve to the previously implanted prosthetic heart valve is characterized by a physical connection apart from an interface provided by a radial pressure of the replacement prosthetic heart valve along an axial length of the previously implanted prosthetic heart valve.

4. The method of claim 1, wherein the replacement prosthetic heart valve includes valve leaflets, and further wherein following fastening, the valve leaflets of the replacement prosthetic heart valve function as natural valve leaflet replacements.

5. The method of claim 4, wherein the previously implanted prosthetic heart valve includes valve leaflets, the method further comprising:

preventing movement of the valve leaflets of the previously implanted prosthetic heart valve.

6. The method of claim 1, wherein the replacement prosthetic heart valve includes a support structure transitionable from a collapsed state to an expanded state, and further wherein the step of positioning the replacement prosthetic heart valve with the previously implanted prosthetic heart valve includes deploying the support structure in the collapsed state.

7. The method of claim 6, further comprising:

transitioning the support structure to the expanded state following the step of positioning the replacement prosthetic heart valve within the previously implanted prosthetic heart valve.

8. The method of claim 1, wherein the replacement prosthetic heart valve includes coupling means, and further wherein physically docking the replacement prosthetic heart valve includes:

securing the coupling means to the previously implanted prosthetic heart valve.

9. The method of claim 8, wherein the coupling means includes an anchor, and further wherein securing the coupling means includes:

attaching the anchor to an inflow side of the previously implanted prosthetic heart valve.

10. The method of claim 9, wherein attaching the anchor includes piercing a surface of the previously implanted prosthetic heart valve.

11. The method of claim 8, wherein the coupling means includes an anchor, and further wherein securing the coupling means includes:

attaching the anchor to an outflow side of the previously implanted prosthetic heart valve.

12. The method of claim 11, wherein the coupling means includes a second anchor, and further wherein securing the coupling means includes:

attaching the second anchor to the inflow side of the previously implanted prosthetic heart valve.

13. The method of claim 8, wherein the coupling means includes a component selected from the group consisting of a barb, clip, staple, eyelet, tab, and hook.

14. The method of claim 8, wherein the replacement prosthetic heart valve includes a support structure transitionable from a contracted state to an expanded state, an end portion of the support structure defining an increased diameter as compared to an intermediate portion in the expanded state, and further wherein the coupling means includes the enlarged diameter end portion and further wherein securing the coupling means includes:

transitioning the support structure to the expanded state; and

lodging the enlarged end portion against the previously implanted prosthetic heart valve.

15. The method of claim 14, wherein the coupling means includes opposing end portions of the support structure having enlarged diameters in the expanded state, and further wherein securing the coupling means further includes:

capturing the previously implanted heart valve between the opposing end portions.

16. The method of claim 1, further comprising:

deploying a gasket material between the previously implanted prosthetic heart valve and the replacement prosthetic heart valve prior to the step of physically docking the replacement prosthetic heart valve.

17. The method of claim 1, further comprising:

deploying a second replacement prosthetic heart valve within an internal region defined by the replacement prosthetic heart valve; and

physically docking the second replacement prosthetic heart valve to the previously implanted prosthetic heart valve.

18. The method of claim 1, wherein the previously implanted prosthetic heart valve includes connection means and the replacement prosthetic heart valve includes coupling means, and further wherein physically docking the replacement prosthetic heart valve to the previously implanted prosthetic heart valve includes securing the coupling means to the connection means.

19. A prosthetic heart valve for functionally replacing a previously implanted prosthetic heart valve, the prosthetic heart valve comprising:

a support structure;

leaflets mounted to the support structure;

coupling means associated with the support structure and adapted to physically dock the prosthetic heart valve to a previously implanted heart valve.

20. The prosthetic heart valve of claim 19, wherein the support structure is a stent.

21. The prosthetic heart valve of claim 20, wherein the stent is transitionable from a collapsed state to an expanded state having an enlarged diameter as compared to the collapsed state.

22. The prosthetic heart valve of claim 21, wherein the coupling means is defined, at least in part, by the stent in the expanded state in which at least one end portion of the stent defines an enlarged diameter as compared to a diameter of an intermediate portion of the stent.

23. The prosthetic heart valve of claim 19, wherein the coupling means is attached to the stent.

24. The prosthetic heart valve of claim 23, wherein the coupling means includes an anchor component consisting of a barb, clip, staple, post, eyelet, and hook.

25. The prosthetic heart valve of claim 19, wherein the coupling means is adapted to retract radially in the collapsed state and extend radially in the expanded state.

26. The prosthetic heart valve of claim 19, wherein the leaflets are formed from a material selected from the group consisting of autologous tissue, xenograph material, and synthetic.

27. The prosthetic heart valve of claim 19, wherein the coupling means extends radially outwardly relative to the leaflets.

28. The prosthetic heart valve of claim 19, further comprising:

a gasket material mounted to an exterior of the support structure.

29. A prosthetic heart valve comprising:

a support structure;

leaflets mounted to the support structure; and

connection means associated with the support structure and adapted to effectuate physical docking of a replacement heart valve to the prosthetic heart valve.

30. The prosthetic heart valve of claim 29, wherein the connection means includes a component selected from the group consisting of a rib, hook, barb, eyelet, ring, clip and staple.

31. The prosthetic heart valve of claim 29, wherein the support structure includes a covering material to which the leaflets are attached, and further wherein the connection means extends from the covering material.

32. The prosthetic heart valve of claim 29, wherein the support structure defines a sewing ring, and further wherein at least a portion of the connection means extends from the sewing ring.

33. The prosthetic heart valve of claim 29, wherein the support structure defines stent posts, and further wherein at least a portion of the connection means extends from the stent posts.

34. The prosthetic heart valve of claim 33, wherein the connection means includes a plurality of protrusions, respective ones of which extend from respective ones of the stent posts.

35. A prosthetic heart valve system comprising:

a first prosthetic heart valve for initial implantation to native heart tissue and including;

a support structure,

leaflets mounted to the support structure,

connection means associated with the support structure; and

a replacement prosthetic heart valve for functionally replacing the first prosthetic heart valve following implant of the first prosthetic heart valve, the replacement prosthetic heart valve including;

a support structure,

leaflets mounted to the support structure,

coupling means associated with the support structure;

wherein the connection means and the coupling means are configured such that the coupling means engages the connection means to physically dock the replacement prosthetic heart valve to the first prosthetic heart valve.

36. The system of claim 35, wherein the connection means and the coupling means include complimentary components.

37. The system of claim 35, wherein the connection means includes a ring and the coupling means includes a protrusion adapted to engage the ring.

38. The system of claim 35, wherein the connection means includes a component extending from an inflow side of the first prosthetic heart valve and the coupling means includes a component extending from an inflow side of the replacement prosthetic heart valve.

39. The system of claim 35, wherein the connection means includes a component extending form an outflow side of the first prosthetic heart valve and the coupling means includes a component extending from an outflow side of the replacement prosthetic heart valve.

40. The system of claim 35, wherein the connection means and coupling means are adapted to provide a longitudinal interface therebetween relative to a length of the first and replacement prosthetic heart valves.