Percutaneous heart valve prosthesis

• US 8,979,922 B2
• Filed: 03/11/2005
• Issued: 03/17/2015
• Est. Priority Date: 03/11/2004
• Status: Active Grant

• Current Assignee: Percutaneous Cardiovascular Solutions Pty Limited (Edwards Lifesciences Corporation)
• Original Assignee: Percutaneous Cardiovascular Solutions Pty Limited (Edwards Lifesciences Corporation)
• Inventors: Jayasinghe, Stayajit Rohan, Thambar, Suku
• Primary Examiner(s): Bui, Vy Q
• Application Number:
  US10/598,716
• Publication Number:
  US 20080243245A1
• Time in Patent Office: 3,658 Days
• Field of Search: 623 21- 242
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• 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 2/2418 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2002/8486 provided on at least one of the ends
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• 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 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical

Abstract

A percutaneous heart valve prosthesis (1) has a valve body (2) with a passage (9) extending between the first and second ends (7, 8) of the valve body (2). The valve body (2) is collapsible about a longitudinal axis (10) of the passage (9) for delivery of the valve body (2) via a catheter (18). One or more flexible valve leaflets (3, 4) are secured to the valve body (2) and extend across the passage (9) for blocking bloodflow in one direction through the passage (9). An anchor device (5), which is also collapsible for delivery via catheter (18), is secured to the valve body (2) by way of an anchor line (6). A failed or failing mitral heart valve (101) is treated by percutaneously locating the valve body (2) in the mitral valve orifice (102) with the anchor device (5) located in the right atrium (107) and engaging the inter-atrial septum (103), such that the taught anchor line (6) acts to secure the valve body (2) within the mitral valve orifice (102).

Claims

1. A percutaneous heart valve prosthesis comprising:

a valve body having a first longitudinal extremity defining a valve body first end a longitudinally opposing second longitudinal extremity defining a valve body second end, said valve body further having a passage extending along a longitudinal axis between said valve body first end and said valve body second end, said valve being collapsible about said longitudinal axis from an uncollapsed state to a collapsed state for delivery via catheter; and

one or more flexible valve elements secured to said valve body and extending across said passage for blocking bloodflow in one direction through said passage from said valve body second end to said valve body first end;

wherein said valve body tapers linearly continuously along its longitudinal extent between said valve body first end and said valve body second end in said uncollapsed state, from said valve body second end to said valve body first end, said valve body first end being sized, in said uncollapsed state, to pass through a valve orifice associated with a heart valve to be replaced, said valve body second end being sized, in said uncollapsed state, so as not to pass through the valve orifice, said second end being broader than said first end in said uncollapsed state.

2. The prosthesis of claim 1 wherein said valve body comprises a collapsible valve body frame formed of elongate elastic valve body elements.

3. The prosthesis of claim 2 wherein said valve body frame elements are each formed of a superelastic shape memory material.

4. The prosthesis of claim 2 wherein said valve body frame comprises at least three valve body sub-frame members, each said valve body sub-frame member having the general form of a deltoid, each said deltoid having acute-angled vertices at said valve body first and second ends, and oblique-angled vertices located between said valve body first and second ends.

5. The prosthesis of claim 4 wherein each said valve body sub-frame member has the general form of a rhombus.

6. The prosthesis of claim 4 wherein adjacent said valve body sub-frame members are joined at respective said oblique-angled vertices.

7. The prosthesis of claim 6 wherein each said sub-frame member further comprises a collapsible diagonal element extending between said oblique-angled vertices.

8. The prosthesis of claim 7 wherein said one or more valve elements is/are secured to said diagonal elements.

9. The prosthesis of claim 4 wherein each said deltoid is substantially planar.

10. The prosthesis of claim 1 wherein said prosthesis is a mitral valve prosthesis.

11. The prosthesis of claim 1 wherein said prosthesis further comprises a plurality of barbs spaced around a periphery of said valve body second end and proiectinq outwardly from said valve body when said valve body is in said uncollapsed state.

12. A percutaneous heart valve replacement system comprising:

a catheter having a catheter first end and a catheter second end;

a prosthesis as defined in claim 1 located in said catheter, said valve body being in a collapsed state and located towards said catheter first end; and

an elongate guide element having a guide element first end and a guide element second end, said guide element first end being detachably attached to said prosthesis and said guide element second end extending beyond said catheter second end.

13. A method of treating a failed or failing mitral valve comprising:

advancing a first end of a catheter through the venous system of a patient to be treated into the right atrium of the patient'"'"'s heart;

creating a puncture in the inter-atrial septum of the heart;

advancing said catheter first end through said puncture, into the left atrium, through the native mitral valve and into the left ventricle of the heart;

locating a prosthesis as defined in claim 1 in said catheter with said valve body in a collapsed state and said valve body second end located between said valve body first end and said catheter first end;

advancing said prosthesis through said catheter until said valve body is released from said catheter first end, thereby expanding said valve body from said collapsed state;

withdrawing said catheter first end through the mitral valve into the left atrium;

withdrawing said valve body toward the left atrium, wedging said valve body in the orifice of the native mitral valve; and

withdrawing said catheter from the patient.

14. A percutaneous heart valve prosthesis comprising:

a valve body having a first longitudinal extremity defining a valve body first end and a longitudinally opposing second longitudinal extremity defining a valve body second end, said valve body further having a passage extending along a longitudinal axis between said valve body first end and said valve body second end, said valve being collapsible from an uncollapsed state to a collapsed state about said longitudinal axis for delivery via catheter;

one or more flexible valve elements secured to said valve body and extending across said passage for blocking bloodflow in one direction through said passage from said valve body second end to said valve body first end; and

a plurality of barbs spaced about a periphery of said valve body second end and projectinq outwardly from said valve body when said valve body is in said uncollapsed state;

wherein said valve body tapers, in said uncollapsed state, toward said valve body first end, said valve body first end being sized, in said uncollapsed state, to pass through a valve orifice associated with a heart valve to be replaced, said valve body second end being sized, in said uncollapsed state, so as not to pass through the valve orifice, said second end being broader than said first end in said uncollapsed state.

15. The prosthesis of claim 14 wherein said valve body comprises a collapsible valve body frame formed of elongate elastic valve body elements.

16. The prosthesis of claim 15 wherein said valve body frame elements are each formed of a superelastic shape memory material.

17. The prosthesis of claim 15 wherein said valve body frame comprises at least three valve body sub-frame members, each said valve body sub-frame member having the general form of a deltoid, each said deltoid having acute-angled vertices at said valve body first and second ends, and oblique-angled vertices located between said valve body first and second ends.

18. The prosthesis of claim 17 wherein each said valve body sub-frame member has the general form of a rhombus.

19. The prosthesis of claim 17 wherein adjacent said valve body sub-frame members are joined at respective said oblique-angled vertices.

20. The prosthesis of claim 19 wherein each said sub-frame member further comprises a collapsible diagonal element extending between said oblique-angled vertices.

21. The prosthesis of claim 20 wherein said one or more valve elements is/are secured to said diagonal elements.

22. The prosthesis of claim 17 wherein each said deltoid is substantially planar.

23. The prosthesis of claim 14 wherein said prosthesis is a mitral valve prosthesis.

24. A percutaneous heart valve replacement system comprising:

a catheter having a catheter first end and a catheter second end;

a prosthesis as defined in claim 14 located in said catheter, said valve body being in a collapsed state and located towards said catheter first end; and

an elongate guide element having a guide element first end and a guide element second end, said guide element first end being detachably attached to said prosthesis and said guide element second end extending beyond said catheter second end.

25. A method of treating a failed or failing mitral valve comprising:

advancing a first end of a catheter through the venous system of a patient to be treated into the right atrium of the patient'"'"'s heart;

creating a puncture in the inter-atrial septum of the heart;

advancing said catheter first end through said puncture, into the left atrium, through the native mitral valve and into the left ventricle of the heart;

locating a prosthesis as defined in claim 14 in said catheter with said valve body in a collapsed state and said valve body second end located between said valve body first end and said catheter first end;

advancing said prosthesis through said catheter until said valve body is released from said catheter first end, thereby expanding said valve body from said collapsed state;

withdrawing said catheter first end through the mitral valve into the left atrium;

withdrawing said valve body toward the left atrium, wedging said valve body in the orifice of the native mitral valve and engaging said prongs with cardiac structure surrounding an end of said orifice; and

withdrawing said catheter from the patient.

26. A percutaneous heart valve prosthesis comprising:

a valve body expandable about a longitudinal axis from a collapsed state to an uncollapsed state, said valve body having longitudinally opposing first and second ends defined in the collapsed state, said valve body defining a passage in the uncollapsed state between said first and second ends, said valve being deliverable via catheter in the collapsed state;

one or more flexible valve elements secured to said valve body and extending across said passage for substantially blocking bloodflow from the second end to the first end through said passage;

wherein said valve body first end being sized in the uncollapsed state to pass through a valve orifice associated with a heart valve to be replaced, said valve body second end being sized in the uncollapsed state so as not to pass through the valve orifice, said second end being broader than said first end in said uncollapsed state.

27. The prosthesis of claim 26 wherein said valve body comprises a collapsible valve body frame formed of elongate elastic valve body elements.

28. The prosthesis of claim 27 wherein said valve body frame elements are each formed of a super elastic shape memory material.

29. The prosthesis of claim 27 wherein said valve body frame comprises at least three valve body sub-frame members, each said valve body sub-frame member having the general form of a deltoid, each said deltoid having acute-angled vertices at said valve body first and second ends, and oblique-angled vertices located between said valve body first and second ends.

30. The prosthesis of claim 29 wherein each said valve body sub-frame member has the general form of a rhombus.

31. The prosthesis of claim 29 wherein adjacent said valve body sub-frame members are joined at respective said oblique-angled vertices.

32. The prosthesis of claim 31 wherein each said sub-frame member further comprises a collapsible diagonal element extending between said oblique-angled vertices.

33. The prosthesis of claim 32 wherein said one or more valve elements is/are secured to said diagonal elements.

34. The prosthesis of claim 29 wherein each said deltoid is substantially planar.

35. The prosthesis of claim 26 wherein said prosthesis is a mitral valve prosthesis.

36. A percutaneous heart valve replacement system comprising:

a catheter having a catheter first end and a catheter second end;

a prosthesis as defined in claim 26 located in said catheter, said valve body being in a collapsed state and located towards said catheter first end; and

an elongate guide element having a guide element first end and a guide element second end, said guide element first end being detachably attached to said prosthesis and said guide element second end extending beyond said catheter second end.

37. A method of treating a failed or failing mitral valve comprising:

advancing a first end of a catheter through the venous system of a patient to be treated into the right atrium of the patient'"'"'s heart;

creating a puncture in the inter-atrial septum of the heart;

advancing said catheter first end through said puncture, into the left atrium, through the native mitral valve and into the left ventricle of the heart;

locating a prosthesis as defined in claim 26 in said catheter with said valve body in a collapsed state and said valve body second end located between said valve body first end and said catheter first end;

advancing said prosthesis through said catheter until said valve body is released from said catheter first end, thereby expanding said valve body from said collapsed state;

withdrawing said catheter first end through the mitral valve into the left atrium;

withdrawing said valve body toward the left atrium,

wedging said valve body in the orifice of the native mitral valve; and

withdrawing said catheter from the patient.

38. The prosthesis of claim 26 which further comprises a plurality of barbs spaced about a periphery of said valve body second end.

39. The prosthesis of claim 26 wherein said valve body tapers from said valve body second end toward said valve body first end.