MULTIPLE COMPONENT PROSTHETIC HEART VALVE ASSEMBLIES AND APPARATUS FOR DELIVERING THEM

• US 20070265701A1
• Filed: 04/30/2007
• Published: 11/15/2007
• Est. Priority Date: 04/29/2006
• Status: Abandoned Application

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Hong, James, Nguyen-Fitterer, Mimi, Ino, Takashi, Gurskis, Donnell
• Application Number:
  US11/742,459
• Publication Number:
  US 20070265701A1
• Time in Patent Office: Days
• US Class Current: 623/2.100
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 2017/00243 cardiac
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts

Abstract

Multiple component heart valves and apparatus and methods for implanting them are provided. The heart valve generally includes a first annular prosthesis and a second valve prosthesis. The first prosthesis includes an annular member compressible from a relaxed condition to a contracted condition to facilitate delivery into a biological annulus, the annular member being resiliently expandable towards the relaxed condition. The first prosthesis also includes guide rails extending therefrom. The second prosthesis includes an annular frame, valve elements, and receptacles for receiving respective guide rails therethrough when the second prosthesis is directed towards the first prosthesis. In addition, a valve holder may releasably carry the valve prosthesis that includes channels for receiving respective guide rails therethrough when the guide rails are received through the valve prosthesis. A delivery tool is also provided that includes an actuator for selectively compressing the annular member into the contracted condition.

Claims

1. A system for replacing a native or prosthetic heart valve within a patient'"'"'s heart, comprising:

a first prosthesis comprising an annular member implantable within the biological annulus and a plurality of elongate guide rails;

a second valve prosthesis comprising an annular frame, at least one valve element, and a plurality of receptacles for slidably receiving respective guide rails therethrough when the second prosthesis is directed towards the first prosthesis; and

a valve holder comprising proximal and distal ends, the second prosthesis being releasably carried by the distal end, the valve holder comprising a plurality of channels for receiving respective guide rails therethrough when the guide rails are received through the receptacles of the second prosthesis.

2. The system of claim 1, wherein the annular member is compressible radially inwardly from a relaxed condition to a contracted condition to facilitate delivery into a biological annulus, the annular member being resiliently expandable towards the relaxed condition.

3. The system of claim 2, further comprising a delivery tool for introducing the first prosthesis into a biological annulus, the delivery tool comprising a plurality of movable arms disposed around a central hub for selectively compressing the annular member between the arms and the hub to place the annular member in the contracted condition.

4. The system of claim 1, wherein the first prosthesis comprises a plurality of guide shields extending upwardly therefrom for guiding the second prosthesis towards the first prosthesis.

5. The system of claim 4, wherein the guide rails are releasably constrained by the guide shields.

6. The system of claim 1, wherein the second prosthesis is releasably attached to a head of the valve holder by one or more sutures.

7. The system of claim 1, wherein the valve holder comprises a plurality of tubular members defining the channels for receiving the guide rails.

8. The system of claim 7, wherein the tubular members are rotatable for severing the guide rails to separate the guide rails from the first prosthesis.

9. The system of claim 7, wherein the tubular members are coupled to a hub on a shaft of the valve holder, the hub being rotatable relative to the shaft for severing the guide rails to separate the guide rails from the first prosthesis.

10. The system of claim 1, wherein the valve holder comprises an actuator that engages the guide rails when the guide rails are received in the channels, the actuator being movable proximally on a shaft of the valve holder for severing the guide rails to separate the guide rails from the first prosthesis.

11. A prosthesis for receiving a valve prosthesis to replace a preexisting natural or prosthetic heart valve within a biological annulus, comprising:

an annular member implantable within the biological annulus;

a sewing cuff extending outwardly from the annular member;

a plurality of elongate leaders comprising a first end coupled to one of the annular member and the sewing cuff for guiding a valve prosthesis towards at least one of the sewing cuff and the annular member; and

connectors on the leaders disposed a predetermined distance from the first end for securing a valve prosthesis relative to the prosthesis.

12. The prosthesis of claim 11, wherein the sewing cuff is configured for receiving one or more connectors for attaching the prosthesis to the biological annulus.

13. The prosthesis of claim 11, wherein the annular member is at least partially expandable from a contracted condition to an enlarged condition.

14. The prosthesis of claim 11, wherein the annular member comprises a central longitudinal axis, the annular member being directable from an enlarged condition having a first cross-section to a contracted condition having a second cross-section smaller than the first condition when the leaders are tensioned inwardly towards the central axis.

15. The prosthesis of claim 14, wherein the annular member changes shape between the enlarged and contracted conditions when the leaders are tensioned inwardly.

16. The prosthesis of claim 14, wherein the annular member has a generally circular cross-section in the enlarged condition and a multiple lobular cross-section in the contracted condition.

17. The prosthesis of claim 11, wherein the first ends of the leaders are fixed to the sewing cuff adjacent the annular member, the leaders being spaced apart about a circumference of the sewing cuff.

18. The prosthesis of claim 11, wherein the connectors comprise ratcheting elements comprising tapered proximal edges and substantially blunt distal edges.

19. The prosthesis of claim 11, wherein the connectors comprise a tapered arrow shape allowing unidirectional penetration through valve prosthesis.

20. The prosthesis of claim 11, wherein the connectors comprise knots.

21. A heart valve assembly implantable within a biological annulus, comprising:

a first prosthesis comprising an annular member implantable within a biological annulus, and a sewing cuff extending outwardly from the annular member;

a second valve prosthesis comprising an annular frame and at least one valve element;

a plurality of elongate leaders extending from the first prosthesis for guiding the second prosthesis towards the first prosthesis; and

connectors on the leaders for securing the second prosthesis relative to the first prosthesis.

22. The heart valve assembly of claim 21, wherein the second prosthesis comprises one of a mechanical valve and a bioprosthetic valve.

23. The heart valve assembly of claim 21, wherein the second prosthesis comprises a plurality of introducers for receiving respective leaders therethrough.

24. The heart valve assembly of claim 23, wherein the introducers comprise tubular members removably secured to respective portions of the second prosthesis.

25. The heart valve assembly of claim 23, wherein the introducers comprise pockets on the second prosthesis.

26. The heart valve assembly of claim 21, wherein the connectors comprise ratcheting elements comprising tapered proximal edges and substantially blunt distal edges.

27. The heart valve assembly of claim 21, wherein the connectors comprise a tapered arrow shape allowing unidirectional penetration through the valve prosthesis.

28. The heart valve assembly of claim 21, wherein the connectors comprise knots.

29. The heart valve assembly of claim 21, wherein the annular member is compressible to a contracted condition to facilitate delivery into a biological annulus and resiliently expandable to an enlarged condition released from the contracted condition.

30. The heart valve assembly of claim 21, wherein the leaders comprise weakened regions above the connectors, the weakened regions configured to break when the leaders are subjected to a predetermined tension.

31. A tool for implanting a prosthesis into a biological annulus, comprising:

an elongate shaft comprising a proximal end and a distal end;

a plurality of supports on the distal end;

a plurality of movable arms on the distal end adjacent the supports; and

an actuator on the proximal end for moving the arms towards and away from the supports for securing and releasing an annular prosthesis between the supports and the arms, the prosthesis being folded into a contracted condition when secured between the supports and the arms.

32. The tool of claim 31, wherein the supports are disposed about a longitudinal axis defined by the shaft, and the arms are offset radially about the longitudinal axis between adjacent supports.

33. The tool of claim 31, wherein the plurality of supports comprise three supports and the plurality of arms comprises three arms, thereby deforming the prosthesis into a generally shamrock shape when the prosthesis is secured between the supports and the arms.

34. A system for delivering a heart valve prosthesis, comprising:

a valve prosthesis comprising a frame carrying one or more leaflets;

a valve holder comprising proximal and distal ends, a head on the distal end; and

one or more fasteners for removably securing the valve prosthesis to the head.

35. The system of claim 34, wherein the one or more fasteners comprise sutures.

36. The system of claim 34, the valve holder comprising a plurality of channels aligned with receptacles on the valve prosthesis for receiving guide rails from a gasket member therethrough.

37. The system of claim 36, further comprising an actuator on the valve holder for severing the guide rails received in the channels.

38. The system of claim 36, wherein the valve holder comprises a plurality of tubular members defining the channels.

39. The system of claim 38, wherein the tubular members are rotatable for severing the respective guide rails received therein.

40. The system of claim 37, wherein the actuator comprises a housing including features for securing free ends of the guide rails therein, the housing being movable proximally relative to the head for pulling the guide rails to cause the guide rails to break.