Prosthetic Heart Valves and Devices, Systems and Methods for Prosthetic Heart Valves

• US 20130261741A1
• Filed: 07/21/2011
• Published: 10/03/2013
• Est. Priority Date: 07/21/2010
• Status: Active Grant

• Current Assignee: Kevin D. Accola
• Original Assignee: Kevin D. Accola
• Inventors: Accola, Kevin D.
• Granted Patent: US 9,474,597 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61B 17/1204 temporary occlusion
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion

Abstract

Described herein is a unique sutureless heart valve that includes a deployment mechanism having a plurality of fasteners. The plurality of fasteners may be actuated at least two states: a disengaged state wherein said plurality of fasteners are retracted, and an engaged state wherein said plurality of fasteners are extended; and further comprising a deployed state wherein said plurality of fasteners, when extended, are irreversibly locked such that said heart valve is securely deployed at the target surgical site. The valve deployment mechanism comprises a ring assembly comprising a first annular member onto which said plurality of fasteners are associated and a second annular member peripheral to said first annular member and comprising a series of windows through which individual fasteners of said plurality of fasteners project.

Claims

1. A sutureless heart valve for use in heart valve replacement surgery at a target surgical site, the sutureless heart valve comprising

a valve component that promotes unidirectional blood flow;

and

a valve deployment mechanism outwardly associated with said valve component, said valve deployment mechanism comprising a plurality of movable fasteners associated therewith and movable to at least two states;

a disengaged state wherein said plurality of fasteners are retracted; and

an engaged state wherein said plurality of fasteners are extended.

2. The sutureless heart valve of claim 1, wherein said valve deployment mechanism comprises a deployed state wherein said plurality of fasteners, when extended, are rigidly locked such that said heart valve is securely deployed at the target surgical site.

3. The sutureless heart valve of claim 2, wherein said deployed state comprises irreversibly locking said fasteners.

4. The sutureless heart valve of claim 1, wherein said outer portion comprises a ring assembly comprising a first annular member onto which said plurality of fasteners are associated.

5. The sutureless heart valve of claim 4, wherein said plurality of fasteners comprises a plurality of metal hooks or barbs.

6. The sutureless heart valve of claim 4, wherein said annular assembly further comprises a second annular member peripheral to said first annular member and comprising a series of windows through which individual fasteners of said plurality of fasteners project.

7. The sutureless heart valve of claim 1, wherein said valve component comprises three cusps.

8. The sutureless heart valve of claim 7, wherein said two or more cusps are derived from tissue.

9. The sutureless heart valve of claim 8, wherein said two or more cusps are comprised of an artificial material.

10. The sutureless heart valve of claim 1, wherein said valve is configured and dimensioned for aortic valve replacement.

11. The sutureless heart valve of claim 1, wherein said valve is configured and dimensioned for mitral valve replacement.

12. The sutureless heart valve of claim 5, wherein said plurality of fasteners are comprised of metal.

13. The sutureless heart valve of claim 12, wherein said metal is titanium.

14. The sutureless heart valve of claim 6, wherein said second annular member slides over said first annular member to lock said plurality of fasteners in a deployed state.

15. The sutureless heart valve of claim 1, wherein said deployment mechanism further comprises a first radially expandable member positioned superiorly to said plurality of fasteners.

16. The sutureless heart valve of claim 15, wherein said deployment mechanism further comprises a second radially expandable member positioned inferiorly to said plurality of fasteners.

17. The sutureless heart valve of claim 15, wherein said first radially expandable member is a skirt of segments.

18. The sutureless heart valve of claim 17, wherein said skirt comprises an overlapping series of segments.

19. The sutureless heart valve of claim 18, wherein said overlapping series of segments which are pivotablly engaged to a ring base.

20. The sutureless heart valve of claim 18, wherein said deployment mechanism actuates said skirt member from a contracted state to a pivoted state, independent to said engaged state of said plurality of fasteners, wherein the pivoted state urges said series of segments in a radial direction.

21. The sutureless heart valve of claim 18, wherein said deployment mechanism actuates said series of segments by rotating said base skirt ring member.

22. The sutureless heart valve of claim 15, wherein said first skirt member is comprised of a thermoplastic material that hardens upon placement at the target surgical site.

23. The sutureless heart valve of claim 22, wherein said thermoplastic material is nitinol or deformable plastic.

24. A sutureless heart valve for use in heart valve replacement surgery at a target surgical site, the sutureless heart valve comprising

a heart valve component;

a valve deployment mechanism associated outwardly with said heart valve component, said valve deployment system comprising a plurality of movable fasteners associated therewith movable to at least two states;

a disengaged state wherein said plurality of fasteners are retracted;

an engaged state wherein said plurality of fasteners are extended; and

deployed state wherein said plurality of fasteners, when extended, are irreversibly locked such that said heart valve is securely deployed at the target surgical site;

wherein said valve deployment mechanism comprises a ring assembly comprising a first annular member onto which said plurality of fasteners are associated and a second annular member peripheral to said first annular member and comprising a series of windows through which individual fasteners of said plurality of fasteners project;

wherein said valve deployment mechanism further comprises a first radially expandable member positioned superiorly to said plurality of fasteners and a second radially expandable member positioned inferiorly to said plurality of fasteners.

25. A heart valve deployment kit for use with a heart valve of claim 24, said kit comprising

a deployment apparatus comprising an elongated conduit having a distal end and a proximal end,

a linkage that is matable with said heart valve, said valve linkage disposed at said distal end;

and

a control unit disposed at or proximate to said proximal end relative to said distal end;

said control unit comprising a first actuator for translating said plurality of fasteners to and from a disengaged and engaged state;

a second actuator for commuting radial expansion of said first and/or second radially expandable members; and

a deployment actuator for effectuating said plurality fasteners into a deployed state.

26. The heart valve deployment kit of claim 25, wherein said deployment actuator also locks said first and second radially expandable members into place.

27. The heart valve deployment kit of claim 26, wherein said deployment actuator also releases said heart valve from said linkage.

28. The heart valve deployment kit of claim 25, further comprising a cannula assembly equipped to anchor in the aorta, connect with a heart/lung machine and to provide a cardioplegia port.

29. The heart valve deployment kit of claim 28, wherein the cannula assembly further comprises a cannula and an inflatable balloon associated with a distal end thereof.

30. The heart valve deployment kit of claim 29, wherein the inflatable balloon is connected to a pump via a tube associated with the cannula.

31. The heart valve deployment kit of claim 28 further comprising a second conduit associated with the cannula and comprising a port that opens at a region in continuity with the target surgical site and occluded to the downstream aorta by said inflatable balloon.

32. A method of repairing or replacing a heart valve at a target surgical site with a sutureless heart valve comprising a valve component having two or more cusps;

and a valve deployment mechanism outwardly associated with said valve component, said valve deployment mechanism comprising a plurality of movable fasteners associated therewith and comprising three states;

a disengaged state wherein said plurality of fasteners are retracted;

an engaged state wherein said plurality of fasteners are extended; and

a deployed state wherein said plurality of fasteners are irreversibly locked in an extended position;

said method comprising

(a) positioning said sutureless heart valve at a first position at said target surgical site, said positioning conducted with the valve deployment mechanism in a disengaged state;

(b) actuating said sutureless heart valve into an engaged state at said first position;

(c) returning said sutureless heart valve into a disengaged state;

(d) repositioning said sutureless heart valve to a subsequent position at said target surgical site;

(e) reactuating said sutureless heart valve into an engaged state following said repositioning; and

(f) deploying said sutureless heart valve to a deployed state following step (e).

33. The method of claim 32, wherein said steps (b)-(e) are repeated at least once before step (f).

34. The method of claim 32, wherein said valve deployment mechanism further comprises a first radially expandable member positioned superiorly to said plurality of fasteners and a second radially expandable member positioned inferiorly to said plurality of fasteners and further comprising the step of radially expanding said first and/or second radially expandable members subsequent to step (e).

35. The method of claim 32 wherein said steps (a)-(f) are conducted with a deployment apparatus comprising

an elongated conduit having a distal end and a proximal end,

a linkage that is matable with said sutureless heart valve, said valve linkage disposed at said distal end;

and

a control unit disposed at or proximate to said proximal end relative to said distal end;

said control unit comprising a first actuator for translating said plurality of fasteners to and from a disengaged and engaged state;

a second actuator for commuting radial expansion of said first and/or second radially expandable members; and

a deployment actuator for effectuating said plurality fasteners into a deployed state.

36. A method of repairing or replacing a heart valve at a target surgical site, said method comprising deploying, at said target surgical site, a sutureless heart valve comprising a valve component for predominantly unidirectional blood flow;

and a valve deployment mechanism outwardly associated with said valve component, said valve deployment mechanism comprising a plurality of movable fasteners associated therewith and comprising three states;

a disengaged state wherein said plurality of fasteners are retracted;

an engaged state wherein said plurality of fasteners are extended; and

a deployed state wherein said plurality of fasteners are irreversibly locked in an extended position.

37. The method of claim 36, wherein said target surgical area is at a heart valve or resected heart valve.

38. The method of claim 37, wherein said heart valve is an aortic heart valve.

39. The method of claim 38, wherein said target surgical area is an annulus of a heart.

40. The method of claim 36, wherein said deploying is conducted with a deployment apparatus comprising

an elongated conduit having a distal end and a proximal end,

a linkage that is matable with said sutureless heart valve, said valve linkage disposed at said distal end;

and

a control unit disposed at or proximate to said proximal end relative to said distal end;

said control unit comprising a first actuator for translating said plurality of fasteners to and from a disengaged and engaged state;

a second actuator for commuting radial expansion of said first and/or second radially expandable members; and

a deployment actuator for effectuating said plurality fasteners into a deployed state.

41. A valve deployment mechanism for implementation with a heart valve component, said mechanism comprising:

a plurality of movable fasteners associated therewith movable to at least two states;

a disengaged state wherein said plurality of fasteners are retracted, and

an engaged state wherein said plurality of fasteners are extended; and

further comprising a deployed state wherein said plurality of fasteners, when extended, are irreversibly locked such that said heart valve is securely deployed at the target surgical site;

wherein said valve deployment mechanism comprises a ring assembly comprising a first annular member onto which said plurality of fasteners are associated and a second annular member peripheral to said first annular member and comprising a series of windows through which individual fasteners of said plurality of fasteners project;

wherein said valve deployment mechanism further comprises a first radially expandable member positioned superiorly to said plurality of fasteners and a second radially expandable member positioned inferiorly to said plurality of fasteners.