Heart valve prosthesis and method

• US 10,166,014 B2
• Filed: 11/20/2009
• Issued: 01/01/2019
• Est. Priority Date: 11/21/2008
• Status: Active Grant

• Current Assignee: Percutaneous Cardiovascular Solutions Pty Limited (Edwards Lifesciences Corporation)
• Original Assignee: Percutaneous Cardiovascular Solutions Pty Limited (Edwards Lifesciences Corporation)
• Inventors: Thambar, Suku, Cook, Martin Christopher, Schreck, Stefan, Jayasinghe, Stayajit Rohan
• Primary Examiner(s): SCHALL, MATTHEW WAYNE
• Application Number:
  US13/130,180
• Publication Number:
  US 20120101571A1
• Time in Patent Office: 3,329 Days
• Field of Search: 623 126, 623 21, 623 124
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/0061 Implements located only on one side of the opening
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2002/8486 provided on at least one of the ends
• 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 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/006 modular

Abstract

A heart valve prosthesis (100) comprises a housing component (110) and a valve component (130). The housing component (110) comprises a housing body (111) having a housing passage (112) extending therethrough. The housing body (111) is configured to be located in, or adjacent to and communicating with, a native valve orifice (16) of a heart (10) and to engage structure of the heart (10) to fix the housing body (111) in relation to the valve orifice (161). The housing component (111) is collapsible for delivery via catheter (2). The valve component (130) comprises a valve body (131) having a valve passage (132) extending therethrough. The valve body (131) is configured to be fixed within the housing passage (112) with the valve passage (132) extending along the housing passage (112). One or more flexible valve elements (131) is/are secured to the valve body and extend across the valve passage (132) for blocking blood flow in a first direction through the valve passage (132) whilst allowing blood flow in the opposing direction. The valve component (130) is collapsible for delivery via catheter (2) separate to the housing component (110). An associated method of replacing a failed or failing heart valve utilising the heart valve prosthesis (100) is also disclosed.

Claims

1. An atrioventricular heart valve prosthesis for replacing an atrioventricular valve of a heart, said prosthesis comprising a housing component and a valve component;

wherein said housing component comprises;

a housing body having an atrial end having a diameter, a ventricular end having a diameter, and a housing passage extending from the atrial end to the ventricular end;

said housing body being configured to be located in, or adjacent to and communicating with, a native atrioventricular valve orifice of the heart;

a ventricular anchoring mechanism secured to said housing body and configured to engage chordae tendineae of the heart downstream of the native atrioventricular valve orifice and within the ventricle of the heart communicating with the native atrioventricular valve orifice, said ventricular anchoring mechanism comprising a super elastic, shape memory, nickel-titanium alloy;

said housing component being configurable between a housing collapsed state for delivery to the native atrioventricular valve orifice via catheterization and a housing expanded state to engage said ventricular anchoring mechanism with the chordae tendineae of the heart to fix said housing body in relation to the native atrioventricular valve orifice;

an atrial anchoring mechanism secured to said housing body and configured to extend over tissue surrounding the native atrioventricular valve orifice within the atrium of the heart communicating with the native atrioventricular valve orifice and to prevent said housing component from migrating into the ventricle when said housing component is in the housing expanded state, said atrial anchoring mechanism comprising a shape memory, nickel-titanium alloy; and

an annular sealing member extending radially outwardly from said housing body at a location between the atrial end and the ventricular end of said housing body and configured to inhibit blood flow from the ventricle to the atrium when said housing component is in the housing expanded state with said housing body disposed within the native atrioventricular valve orifice, the sealing member having an outer diameter greater than the diameters of the atrial end and the ventricular end of said housing body;

further wherein said valve component comprises;

a valve body having a valve passage extending therethrough;

said valve body being separate from said housing component and being configured to be located at least partially within said housing passage with said valve passage extending along said housing passage; and

one or more flexible valve elements secured to said valve body and extending across said valve passage for blocking blood flow in a first direction through said valve passage whilst allowing blood flow in an opposing second direction through said valve passage;

said valve component being configurable between a valve collapsed state for delivery to said housing passage via catheterization following delivery of said housing component to the native atrioventricular valve orifice and with said housing body in said housing expanded state, and a valve expanded state to engage said housing component and/or structure of the heart to fix said valve body at least partially within said housing passage.

2. The prosthesis of claim 1 wherein said ventricular anchoring mechanism includes a plurality of ventricular prongs secured to and spaced about said housing body.

3. The prosthesis of claim 2 wherein said ventricular prongs are each secured to said housing body by one or more legs extending from the ventricular end of said housing body.

4. The prosthesis of claim 1 wherein said atrial anchoring mechanism is further configured to engage a wall of the atrium of the heart communicating with the native valve orifice.

5. The prosthesis of claim 4 wherein said atrial anchoring mechanism further comprises a plurality of atrial prongs secured to and spaced about said housing body, said atrial prongs being located such that, in use, said atrial prongs engage the wall of the atrium.

6. The prosthesis of claim 1 wherein said housing body comprises a housing body frame formed of one or more elongate elastic housing body frame elements.

7. The prosthesis of claim 6 wherein said housing body further comprises a flexible housing wall fixed to said housing body frame and extending about said housing passage.

8. The prosthesis of claim 1 wherein said housing body is substantially cylindrical.

9. The prosthesis of claim 1 wherein said housing body is tapered.

10. The prosthesis of claim 1 wherein said housing passage is double- tapered, defining a housing passage neck portion located between opposing ends of said housing passage, further wherein said valve body is double-tapered, defining a valve body neck portion adapted to co-operate with said housing passage neck portion to secure said valve body within said housing passage.

11. The prosthesis of claim 1 wherein said valve body comprises a valve body frame formed of one or more elongate elastic valve body frame elements.

12. The prosthesis of claim 1 wherein said valve component comprises a stent valve, said valve body being configured to be fixed at least partially within said housing passage by expansion of said valve body.

13. The prosthesis of claim 1 wherein said housing component further comprises one or more flexible temporary valve elements secured to said housing body and extending across said housing passage for inhibiting blood flow in said first direction through said housing passage whilst allowing blood flow in said second direction through said housing passage prior to delivery of said valve component.

14. The prosthesis of claim 1 wherein said valve component includes a collapsible anchor device for anchoring said valve body to a septum of the heart and a flexible anchor line extending between said valve body and said anchor device, said anchor device being collapsible for delivery via catheterization with said valve body.

15. The prosthesis of claim 1 wherein said prosthesis is a mitral valve prosthesis for replacing a mitral valve.

16. The prosthesis of claim 1 wherein said valve passage extends from a valve inlet to a valve outlet and the one or more flexible valve elements are configured to block blood flow in the first direction through said valve passage from the valve outlet toward the valve inlet and allow blood flow in the opposing second direction through said valve passage from the valve inlet through the valve outlet and toward said ventricular anchoring mechanism.

17. The prosthesis of claim 1 wherein said housing collapsed state is an unstable state and said housing expanded state is a stable state, said housing component being elastically collapsible from the stable housing expanded state into the unstable housing collapsed state and self-expandable back to the stable housing expanded state.

18. The prosthesis of claim 1 wherein said valve collapsed state is an unstable state and said valve expanded state is a stable state, said valve component being elastically collapsible from the stable valve expanded state into the unstable valve collapsed state and self-expandable back to the stable valve expanded state.

24. The prosthesis of claim 1 wherein said prosthesis is a tricuspid valve prosthesis for replacing a tricuspid valve.

28. The prosthesis of claim 1 wherein said housing body comprises a housing body frame and a flexible housing wall fixed to said housing body frame and extending circumferentially about said housing passage and axially from the atrial end to the ventricular end of said housing body.

19. An atrioventricular heart valve prosthesis for replacing an atrioventricular valve of a heart between an atrium and a ventricle of the heart, said prosthesis comprising a housing component and a valve component;

wherein said housing component comprises;

a housing body having an atrial end, a ventricular end, and a housing passage extending from the atrial end to the ventricular end;

said housing body being configured to be located in, or adjacent to and communicating with, a native atrioventricular valve orifice of said atrioventricular valve of the heart;

an anchoring mechanism secured to said housing body and configured to engage tissue of the heart;

said housing component being configurable between a housing collapsed state for delivery to the native atrioventricular valve orifice via catheterization and a housing expanded state to engage said anchoring mechanism with the sub-valvular tissue of the heart to fix said housing body in relation to the native atrioventricular valve orifice; and

an annular sealing member extending radially outwardly from said housing body at a location between the atrial end and the ventricular end of said housing body and configured to inhibit blood flow from the ventricle to the atrium when said housing component is in the housing expanded state with said housing body disposed within the native atrioventricular valve orifice, the sealing member extending beyond the atrial end and the ventricular end of said housing body in a radial direction;

further wherein said valve component comprises;

a valve body having a valve passage extending therethrough;

said valve body being separate from said housing and being configured to be located at least partially within said housing passage with said valve passage extending along said housing passage; and

one or more flexible valve elements secured to said valve body and extending across said valve passage for blocking blood flow in a first direction through said valve passage whilst allowing blood flow in an opposing second direction through said valve passage;

said valve component being configurable between a valve collapsed state for delivery to said housing passage via catheterization following delivery of said housing component to the native atrioventricular valve orifice and with said housing body in said housing expanded state, and a valve expanded state to engage said housing component and/or structure of the heart to fix said valve body at least partially within said housing passage;

further wherein said housing component further comprises one or more flexible temporary valve elements secured to said housing body and extending across said housing passage for inhibiting blood flow in said first direction through said housing passage whilst allowing blood flow in said second direction through said housing passage prior to delivery of said valve component.

20. The prosthesis of claim 19 wherein said valve passage extends from a valve inlet to a valve outlet and the one or more flexible valve elements are configured to block blood flow in the first direction through said valve passage from the valve outlet toward the valve inlet and allow blood flow in the opposing second direction through said valve passage from the valve inlet through the valve outlet and toward said anchoring mechanism.

21. The prosthesis of claim 19 wherein said housing collapsed state is an unstable state and said housing expanded state is a stable state, said housing component being elastically collapsible from the stable housing expanded state into the unstable housing collapsed state and self-expandable back to the stable housing expanded state.

22. The prosthesis of claim 19 wherein said valve collapsed state is an unstable state and said valve expanded state is a stable state, said valve component being elastically collapsible from the stable valve expanded state into the unstable valve collapsed state and self-expandable back to the stable valve expanded state.

23. The prosthesis of claim 19 wherein said anchoring mechanism engages tissue of the heart that is downstream of the native atrioventricular valve orifice and within the ventricle.

25. The prosthesis of claim 19 wherein said prosthesis is a mitral valve prosthesis for replacing a mitral valve.

26. The prosthesis of claim 19 wherein said prosthesis is a tricuspid valve prosthesis for replacing a tricuspid valve.

27. The prosthesis of claim 19 wherein said anchoring mechanism comprises a ventricular anchoring mechanism and said housing component comprises an atrial anchoring mechanism secured to said housing body and configured to extend over tissue surrounding the native atrioventricular valve orifice within the atrium and to prevent said housing component from migrating into the ventricle when said housing component is in the housing expanded state.

29. An atrioventricular heart valve prosthesis for replacing a native atrioventricular valve of a heart between an atrium and a ventricle of the heart, said prosthesis comprising a housing component and a valve component;

wherein said housing component comprises;

a housing body having an atrial end, a ventricular end, and a housing passage extending from the atrial end to the ventricular end;

said housing body being configured to be deployed in the native atrioventricular valve such that the atrial end is located within the atrium and the ventricular end is located within the ventricle, said housing body comprising a housing body frame and a flexible housing wall fixed to said housing body frame and extending about said housing passage; and

a ventricular anchoring mechanism secured to said housing body and configured to engage sub-valvular tissue of the heart within the ventricle;

an atrial anchoring mechanism secured to said housing body and configured to extend over tissue surrounding the native atrioventricular valve within the atrium;

said housing component being configurable between a housing collapsed state for delivery to the native atrioventricular valve via catheter and a housing expanded state in which said housing body is deployed within the native atrioventricular valve, the ventricular anchoring mechanism is deployed in the ventricle and engages sub-valvular tissue, and the atrial anchoring mechanism is deployed in the atrium and is positioned to prevent said housing component from migrating into the ventricle;

an annular sealing member extending radially outwardly from said housing body at a location between the atrial end and the ventricular end of said housing body so as to be deployed within the atrium and inhibit blood flow between the atrium and the ventricle when said housing component is in the housing expanded state, the sealing member extending beyond the atrial end and the ventricular end of said housing body in a radial direction;

further wherein said valve component comprises;

a valve body having a valve passage extending therethrough;

said valve body being separate from said housing component and being configured to be located at least partially within said housing passage with said valve passage extending along said housing passage; and

one or more flexible valve elements secured to said valve body and extending across said valve passage for blocking blood flow in a first direction through said valve passage whilst allowing blood flow in an opposing second direction through said valve passage;

said valve component being configurable between a valve collapsed state for delivery to said housing passage via catheter following delivery of said housing component to the native atrioventricular valve and with said housing body in said housing expanded state, and a valve expanded state to engage said housing component and/or structure of the heart to fix said valve body at least partially within said housing passage.

30. The prosthesis of claim 29 wherein said housing body frame, said ventricular anchoring mechanism, and said atrial anchoring mechanism are made of a shape memory alloy.

31. The prosthesis of claim 29 wherein said valve component is configured such that an atrial end of said valve body extends beyond the sealing member in a direction toward the atrium when said valve component is in the expanded state engaging said housing component.

32. The prosthesis of claim 29 wherein said flexible housing wall is made of polyester.