Device And Method For Improving Function Of Heart Valve

• US 20100145440A1
• Filed: 11/12/2007
• Published: 06/10/2010
• Est. Priority Date: 11/13/2006
• Status: Active Grant

• Current Assignee: Medtentia International Ltd. Oy
• Original Assignee: Medtentia International Ltd. Oy
• Inventors: Keränen, Olli
• Granted Patent: US 8,663,322 B2
• Time in Patent Office: Days
• US Class Current: 623/2.370
• 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, and

a first flange unit being connected to said first loop-shaped support, and which is configured to be arranged against said annulus when said first loop-shaped support is abutting said heart valve, and

wherein said flange unit is configured to provide a sealing surface.

2. The device according to claim 1, further comprising 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.

3. The device according to claim 2, wherein the first loop-shaped support is continuous with the second loop-shaped support to form a coil-shaped body.

4. The device according to claim 2, wherein said first flange unit extends from the first loop-shaped support to said second loop-shaped support, whereby said 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.

5. The device according to claim 2, wherein said second loop-shaped support comprises a second flange unit being connected thereto, which 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.

6. The device according to claim 5, wherein at least one of said first and second flange unit is adapted to form a connection of at least one of the loop-shaped supports and a prosthetic valve against said annulus.

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

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

9. The device according to claim 5, wherein at least one of said first and second flange unit is of a fabric material.

10. The device according to claim 5, wherein at least one of said first and second flange unit comprises a reinforcing element.

11. The device according to claim 5, wherein at least one of said first and second flange unit extends out from and forms an angle (a) of 30-60°

and more preferably 40-50°

below a diametric plane formed by one of said loop-shaped supports, at least prior to use or implantation thereof.

12. The device according to claim 5, wherein at least one of said first and second flange unit extends radially inwards or outwards from its corresponding loop-shaped support.

13. The device according to claim 5, wherein said first side of the heart valve is the atrial side and said second side is the ventricle side.

14. The device according to claim 1, wherein said device is adapted to carry an artificial prosthetic heart valve.

15. The device according to claim 1, wherein said flange unit is arranged to change shape during insertion by a resilient arrangement thereof.

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

17. The device according to claim 2, wherein said flange unit is integral with at least a portion of said first and/or second supports.

18. The device according to claim 2, wherein said flange unit is made of a tube shaped flexible material being passed onto said first and/or second supports, such that it is arranged in a substantially co-axial connection

19. A kit of a medical device according to claim 1, for improving the function of a heart valve, and an artificial prosthetic heart valve attachable or attached to said medical device.

20. The kit according to claim 19, wherein said artificial prosthetic heart valve is arranged on a loop-shaped support or a flange unit of the medical device.

21. The kit according to claim 19, wherein said artificial prosthetic heart valve may 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.

29. The method according to claim 22, comprising using a device according to any of claims 1 to 18.

22. A method for repairing a heart valve comprised of valve tissue including an annulus and a plurality of leaflets for allowing and preventing blood flow, said method comprising:

inserting a medical device comprising at least one loop-shaped support and at least one flange unit being connected to said loop-shaped support to a heart valve,

positioning said loop-shaped support such that it abuts a first side of the heart valve,

positioning said flange unit such that it abuts said annulus,

sealing said flange unit against said annulus with a sealing surface of said flange unit, and

fixating said device by attaching said flange unit to said annulus.

23. The method according to claim 22, wherein said flange unit is attached to said annulus by using sutures or clips.

24. The method according to claim 22, wherein said flange unit is conformed to the annulus (20) before fixating said device (40).

25. The method according to claim 22, wherein the device is inserted to the heart valve by using a catheter, whereupon the catheter is withdrawn leaving the device

26. The method according to claim 22, wherein said first side of the heart valve is the atrial side.

27. The method according to claim 26, comprising reducing or preventing a backflow of blood from a ventricle side to said atrial side of said heart valve by said sealing.

28. The method according to claim 26, comprising preventing paravalvular leakage by said sealing.

30. The A method for replacing a heart valve comprised of valve tissue including an annulus and a plurality of leaflets for allowing and preventing blood flow, the method comprising:

inserting a medical device comprising an artificial valve, at least a loop-shaped support and at least one flange unit being connected to the loop-shaped support to a heart valve,

positioning the loop-shaped support such that it abuts a first side of the heart valve,

positioning the flange unit such that it abuts the annulus,

sealing said flange unit against said annulus with a sealing surface of said flange unit, and

fixating the device by attaching the flange unit to the annulus.

31. A method of treating a heart valve problem comprising:

providing an implant having a loop-shaped support frame and a flange connected to said loop-shaped support frame;

abutting said loop-shaped support frame against a first side of said heart valve;

positioning said flange against an annulus of said heart valve;

sealing said flange and said annulus; and

attaching said flange to said annulus.