APPARATUS AND METHOD FOR REPLACING A DISEASED CARDIAC VALVE

• US 20100312333A1
• Filed: 04/28/2010
• Published: 12/09/2010
• Est. Priority Date: 04/29/2009
• Status: Abandoned Application

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Zhou, Qun, Navia, Jose Luis, Chen, Ji-Feng
• Application Number:
  US12/769,593
• Publication Number:
  US 20100312333A1
• Time in Patent Office: Days
• US Class Current: 623/2.36
• 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0066 stapled
• 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 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2310/00023 Titanium or titanium-based alloys, e.g. Ti-Ni alloys

Abstract

An apparatus is provided for replacing a native cardiac valve. The native cardiac valve has at least one leaflet and is surrounded by a native cardiac valve annulus having superior and inferior aspects. The apparatus comprises a barbell-shaped, expandable anchoring member including first, second, and main body portions extending between the end portions. The main body portion includes a channel defined by inner and outer surfaces. Each of the first and second end portions has a diameter greater than the diameter of the main body portion. The first and second end portions are sized to respectively contact the superior and inferior aspects of the native cardiac valve annulus when the expandable anchoring member is in an expanded configuration. The apparatus also includes an expandable support member operably disposed within the main body portion of the expandable anchoring member, and a prosthetic cardiac valve secured within the expandable support member.

Claims

1. An apparatus for replacing a native cardiac valve, the native cardiac valve having at least one leaflet and being surrounded by a native cardiac valve annulus, the native cardiac valve annulus having a superior aspect and an inferior aspect, said apparatus comprising:

a barbell-shaped expandable anchoring member including a first end portion, a second end portion, and a main body portion extending between said end portions, said main body portion including a channel defined by an inner surface and an outer surface, each of said first and second end portions having a diameter greater than the diameter of said main body portion, said first and second end portions being sized to respectively contact the superior and inferior aspects of the native cardiac valve annulus when said expandable anchoring member is in an expanded configuration;

an expandable support member operably disposed within said main body portion of said expandable anchoring member; and

a prosthetic cardiac valve secured within said expandable support member.

2. The apparatus of claim 1, wherein said expandable anchoring member is comprised of a single strand of a flexibly resilient material.

3. The apparatus of claim 1, wherein each of said first and second end portions has a hemi-spherical shape with respect to an axial plane of the said main body portion of said expandable anchoring member.

4. The apparatus of claim 1, wherein each of said first and second end portions has a bulbous shape with respect to an axial plane of the said main body portion of said expandable anchoring member.

5. A method for replacing a native cardiac valve, the native cardiac valve having at least one leaflet and being surrounded by a native cardiac valve annulus, the native cardiac valve annulus having a superior aspect and an inferior aspect, said method comprising the steps of:

providing an apparatus comprising a barbell-shaped expandable anchoring member, an expandable support member, and a prosthetic cardiac valve secured within the expandable support member, the expandable support member being secured within the expandable anchoring member, each of the first and second end portions having a diameter greater than the diameter of the main body portion;

placing the apparatus into a delivery catheter;

inserting the delivery catheter into an atrial chamber;

advancing the delivery catheter until the delivery catheter is positioned within the native cardiac valve annulus; and

removing the apparatus from the delivery catheter so that the expandable anchoring member obtains an expanded configuration and the first and second end portions of the expandable anchoring member respectively contact the superior and inferior aspects of the native cardiac valve annulus and thereby secure the expandable anchoring member in the native cardiac annulus.

6. An apparatus for replacing a native cardiac valve, the native cardiac valve having at least one leaflet and being surrounded by a native cardiac valve annulus, the native cardiac valve annulus having a superior aspect and an inferior aspect, said apparatus comprising:

an expandable support member;

a prosthetic cardiac valve operably secured within said expandable support member; and

a securing member operably connected to said expandable support member, said securing member comprising an elongated body member having a first end, a second end, and a main body portion extending between said first and second ends, said second end including a first attachment member operably connected thereto for contacting the inferior aspect of the native cardiac valve annulus when said expandable support member is in an expanded configuration.

7. The apparatus of claim 6, wherein said first attachment member includes at least one rod-shaped puncturing member for embedding into the tissue of the native cardiac valve annulus when said expandable support member is in an expanded configuration.

8. The apparatus of claim 6, wherein said first end of said securing member includes a second attachment member operably connected thereto for contacting the superior aspect of the native cardiac valve annulus when said expandable support member is in an expanded configuration.

9. The apparatus of claim 8, wherein each of said first and second attachment members has a loop-shaped configuration that extends substantially axial to said elongated body member of said securing member when said expandable support member is in an expanded configuration.

10. The apparatus of claim 8, wherein each of said first and second attachment members comprises a flexible, rod-shaped member that extends substantially axial to said elongated body member of said securing member when said expandable support member is in an expanded configuration.

11. The apparatus of claim 8, wherein each of said first and second attachment members comprises a windable coil that extends substantially axial to said elongated body member of said securing member when said expandable support member is in an expanded configuration.

12. The apparatus of claim 8, wherein said first attachment member comprises an anchoring ring and said second attachment member comprises a windable coil, said anchoring ring and said windable coil extending substantially axial to said elongated body member of said securing member when said expandable support member is in an expanded configuration.

13. The apparatus of claim 8, wherein said first attachment member comprises a flexible, rod-shaped member and said second attachment member comprises a windable coil, said rod-shaped member and said windable coil extending substantially axial to said elongated body member of said securing member when said expandable support member is in an expanded configuration.

14. The apparatus of claim 6, wherein a layer of biocompatible material is connected to a portion of said elongated body member of said securing member to prevent or mitigate leakage of blood flow between said expandable support member and the native cardiac valve annulus.

15. A method for replacing a native cardiac valve, the native cardiac valve having at least one leaflet and being surrounded by a native cardiac valve annulus, the native cardiac valve annulus having a superior aspect and an inferior aspect, said method comprising the steps of:

providing an apparatus comprising an expandable support member having a prosthetic cardiac valve secured therein and a securing member operably connected to the expandable support member, the securing member comprising an elongated body member having a first end, a second end, and a main body portion extending between the first and second ends, the second end including a first attachment member operably connected thereto;

placing the expandable anchoring member into a delivery catheter;

inserting the apparatus into an atrial chamber;

advancing the delivery catheter until the delivery catheter is positioned within the native cardiac valve annulus; and

removing the apparatus from the delivery catheter so that the expandable support member obtains an expanded configuration and the first attachment member of the securing member contacts the inferior aspect of the native cardiac valve annulus and thereby secures the expandable support member in the native cardiac valve annulus.

16. An apparatus for replacing a native cardiac valve, the native cardiac valve having at least one leaflet and being surrounded by a native cardiac valve annulus, the native cardiac valve annulus having a superior aspect and an inferior aspect, said apparatus comprising:

a securing member comprising an elongated body member having a first end, a second end, and a main body portion extending between said first and second ends, said second end including a first attachment member operably connected thereto for contacting the inferior aspect of the native cardiac valve annulus when said expandable support member is in an expanded configuration; and

a prosthetic valve operably secured to said securing member.

17. The apparatus of claim 16, wherein said first attachment member includes at least one rod-shaped puncturing member for embedding into the tissue of the native cardiac valve annulus when said expandable support member is in an expanded configuration.

18. The apparatus of claim 16, wherein said first end of said securing member includes a second attachment member operably connected thereto for contacting the superior aspect of the native cardiac valve annulus when said expandable support member is in an expanded configuration.

19. The apparatus of claim 18, wherein each of said first and second attachment members has a loop-shaped configuration that extends substantially axial to said elongated body member of said securing member when said expandable support member is in an expanded configuration.

20. The apparatus of claim 18, wherein each of said first and second attachment members comprises a flexible, rod-shaped member that extends substantially axial to said elongated body member of said securing member when said expandable support member is in an expanded configuration.

21. The apparatus of claim 18, wherein each of said first and second attachment members comprises a windable coil that extends substantially axial to said elongated body member of said securing member when said expandable support member is in an expanded configuration.

22. The apparatus of claim 18, wherein said first attachment member comprises an anchoring ring and said second attachment member comprises a windable coil, said anchoring ring and said windable coil extending substantially axial to said elongated body member of said securing member when said expandable support member is in an expanded configuration.

23. The apparatus of claim 18, wherein said first attachment member comprises a flexible, rod-shaped member and said second attachment member comprises a windable coil, said rod-shaped member and said windable coil extending substantially axial to said elongated body member of said securing member when said expandable support member is in an expanded configuration.

24. The apparatus of claim 16, wherein a layer of biocompatible material is connected to a portion of said elongated body member of said securing member to prevent or mitigate leakage of blood flow between said expandable support member and the native cardiac valve annulus.

25. A method for replacing a native cardiac valve, the native cardiac valve having at least one leaflet and being surrounded by a native cardiac valve annulus, the native cardiac valve annulus having a superior aspect and an inferior aspect, said method comprising the steps of:

providing an apparatus comprising a securing member and a prosthetic cardiac valve operably connected to the securing member, the securing member comprising an elongated body member having a first end, a second end, and a main body portion extending between the first and second ends, the second end including a first attachment member operably connected thereto for contacting the inferior aspect of the native cardiac valve annulus when the expandable support member is in an expanded configuration;

placing the apparatus into a delivery catheter;

inserting the delivery catheter into an atrial chamber;

advancing the delivery catheter until the delivery catheter is positioned within the native cardiac valve annulus; and

removing the apparatus from the delivery catheter so that the prosthetic cardiac valve expands in place of the native cardiac valve and the first attachment member of the securing member contacts the inferior aspect of the native cardiac valve annulus and thereby secures the prosthetic cardiac valve in the native cardiac valve annulus.