Device and method for improving function of heart valve

• US 8,734,507 B2
• Filed: 06/15/2012
• Issued: 05/27/2014
• 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:
  US13/525,104
• Publication Number:
  US 20120316643A1
• Time in Patent Office: 711 Days
• Field of Search: 623/2.18, 623 236- 237, 623/1.24, 623/2.1
• 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, which is configured to abut a first side of the heart valve,

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, and

a second loop-shaped support, which is 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 supports

wherein the first loop-shaped support is continuous with the second loop-shaped support to form a coil-shape that does not interfere with movement of said plurality of leaflets during normal heart action when said portion of said valve tissue is trapped between the first and second supports and

wherein said first flange unit is configured for fixing said device to said valve and comprises a reinforcing element.

2. The device according to claim 1, wherein said first reinforcing element is a bead or a thread.

3. The device according to claim 1, wherein the first flange unit comprises fixation elements, a tissue adhesive, or both, configured for fixating the medical device to said annulus.

4. The device according to claim 1, wherein said first flange unit is adapted for fixation of a prosthetic valve thereto.

5. The device according to claim 1, wherein said first flange unit extends from the first loop-shaped support to said second loop-shaped support, whereby said first flange unit is configured to be arranged against the annulus on opposite sides of the valve tissue being trapped between the first and second supports.

6. 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.

7. The device according to claim 6, wherein said second flange unit comprises a second reinforcing element.

8. The device according to claim 7, wherein said second reinforcing element is a bead or a thread.

9. The device according to claim 6, wherein said second flange unit comprises fixation elements, a tissue adhesive, or both, configured for fixating the medical device to said annulus.

10. The device according to claim 6, wherein at least one of said first and second flange unit has an intermittent extension along the periphery of its corresponding loop-shaped support.

11. The device according to claim 6, wherein at least one of said first and second flange units has a continuous extension along the periphery of its corresponding loop-shaped support.

12. The device according to claim 6, wherein at least one of said first and second flange unit is made of a material selected from the group consisting of:

a fabric, polyethylene, polytetrafluoroethylene, and a shape memory material.

13. The device according to claim 6, wherein said first or second flange unit extends out from, and forms an angle (a) of 30-60°

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

14. The device according to claim 6, wherein at least one of said first and second flange unit extends radially inwards or outwards from its corresponding loop-shaped support.

15. The device according to claim 6, wherein said first side of the heart valve is the atrial side and said second side is the ventricular side.

16. The device according to claim 6, wherein at least one of said first and second flange units is adapted to form a connection of at least one of the first and second loop-shaped supports with a prosthetic valve against said annulus.

17. A kit comprising a medical device according to claim 1 and a prosthetic heart valve fixed to or fixable to said first flange unit.

18. A kit comprising a medical device according to claim 6 and a prosthetic heart valve fixed to or fixable to at least one of said first and second flange units.

19. The device according to claim 1, wherein said reinforcing element is on an outer periphery of said first flange unit.

20. The device according to claim 1, wherein an end of said device is configured to pass through a commissure of said heart valve commissure.