Device and method for improving function of heart valve

• US 8,663,322 B2
• Filed: 11/12/2007
• Issued: 03/04/2014
• Est. Priority Date: 11/13/2006
• Status: Active Grant

• Current Assignee: Medtentia International Ltd. Oy
• Original Assignee: Medtentia International Ltd. Oy
• Inventors: Kernen, Olli
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Mathew, Seema
• Application Number:
  US12/514,795
• Publication Number:
  US 20100145440A1
• Time in Patent Office: 2,304 Days
• Field of Search: 623 236- 237
• US Class Current: 623/2.36
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/006 modular

Abstract

A device for improving the function of a heart valve comprises a first loop-shaped support, which is configured to abut a first side of the heart valve, and a first flange unit being connected to said first loop-shaped support. The flange unit is configured to be arranged against said annulus when said first loop-shaped support is abutting said heart valve.

Claims

1. A medical device for improving the function of a heart valve comprised of valve tissue including an annulus and a plurality of leaflets, the medical device comprising:

a first loop-shaped support configured to abut a first side of the heart valve,

a second loop-shaped support configured to abut a second side of the heart valve opposite to said first side, whereby a portion of the valve tissue is trapped between the first and second loop-shaped supports, and

a first flange unit connected to said first loop-shaped support and configured to provide a sealing surface against said annulus when said first loop-shaped support is positioned in abutment to said heart valve,

wherein

the first loop-shaped support is continuous with the second loop-shaped support to form a coil-shaped body and

said first flange unit extends radially inward from said first loop-shaped support and is positioned such that, when positioned in abutment to said heart valve, said first flange unit provides support for the valve leaflets.

2. The device according to claim 1, wherein said second loop-shaped support comprises a second flange unit being connected thereto, which second flange unit is configured to be arranged against said annulus on a side thereof being opposite the first loop-shaped support when said second loop-shaped support is abutting said heart valve.

3. The device according to claim 2, wherein at least one of said first flange unit and said second flange unit is adapted to form a connection of at least one of the loop-shaped supports with a prosthetic valve.

4. The device according to claim 2, wherein at least one of said first flange unit and said second flange unit has an intermittent extension along a periphery of its corresponding loop-shaped support.

5. The device according to claim 2, wherein at least one of said first flange unit and said second flange unit has a continuous extension along a periphery of its corresponding loop-shaped support.

6. The device according to claim 2, wherein at least one of said first flange unit and said second flange unit is made of a fabric material.

7. The device according to claim 2, wherein at least one of said first flange unit and said second flange unit comprises a reinforcing element.

8. The device according to claim 2, wherein said first flange unit and said second flange unit extend out from, and forms an angle (a) of 30-60°

below a diametric plane formed by said first loop-shaped support, at least prior to implantation of the device.

9. The device according to claim 2, wherein at least one of said first flange unit and said second flange unit extends radially outwards from its corresponding loop-shaped support.

10. The device according to claim 2, wherein said first side of the heart valve is the atrial side and said second side is the ventricle side.

11. The device according to claim 1, wherein said first flange unit is configured to change shape during insertion into said valve by a resilient arrangement of said first flange unit.

12. The device according to claim 1, wherein said first flange unit comprises a shape memory material and is arranged to return to a pre-defined shape during insertion of the medical device into said valve.

13. The device according to claim 1, wherein said first flange unit is integral with at least a portion of said first and/or second loop-shaped supports.

14. The device according to claim 1, wherein said first flange unit is made of a tube shaped flexible material being passed onto said first and/or second loop-shaped supports, such that said first flange unit is arranged in a substantially co-axial connection.

15. A kit comprising a medical device according to claim 1 and an artificial prosthetic heart valve attachable or attached to said medical device.

16. The kit according to claim 15, wherein said artificial prosthetic heart valve is arranged on a loop-shaped support or a flange unit of the medical device.

17. The kit according to claim 15, wherein said artificial prosthetic heart valve is configured to be arranged on said loop-shaped support or flange unit of the medical device intended to be positioned on the atrial side of an annulus of said heart valve.

18. The device according to claim 2, wherein said second flange unit extends out from, and forms an angle (a) of 30-60°

below, a diametric plane formed by said second loop-shaped support, at least prior to implantation of the device.

19. The device according to claim 2, wherein said second flange unit is configured to form two flange surfaces arranged on said second loop-shaped support to overlap commissures of said valve when the device is arranged in the heart valve abutting the annulus.