Device And Method For Improving Fixation Of A Medical Device

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

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

a fabric sleeve at least partly covering said first loop-shaped support,

wherein said sleeve is folded over itself to form a first flange and said first flange is reshapeable to a final shape before implantation.

2 . The device of claim 1 , wherein said sleeve comprises a flange portion extending from said first loop-shaped support wherein said flange portion is configured to overlap a surface of, and form a collar around, at least a portion of said annulus.

3 . The device of claim 2 , wherein said fabric sleeve comprises a casing portion configured to cover said first loop-shaped support and a flange portion extending from said casing portion and configured to overlap a surface on the annulus.

4 . The device of claim 2 , wherein said flange is formed of a double layer of opposed fabrics of said sleeve.

5 . The device of claim 2 , wherein said flange is arranged radially outwards from said loop-shaped support.

6 . The device of claim 2 , further comprising 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 supports.

7 . The device of claim 6 , wherein the first loop-shaped support is continuous with the second loop-shaped support to form a coil-shaped body.

8 - 12 . (canceled)

13 . The device of claim 17 , wherein at least one of said first and second flanges is configured to provide a sealing surface against said heart valve.

14 . The device of claim 17 , wherein at least one of said first and second flanges is conformable to said annulus before fixation of the device.

15 . A kit for improving the function of a heart valve, said kit comprising:

a medical device and an artificial prosthetic heart valve attachable or attached to said medical devices, wherein said medical device comprises:

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

a fabric sleeve at least partly covering said first loop-shaped support,

wherein said fabric sleeve is folded over itself to form a first flange and said first flange is reshapeable to a final shape before implantation.

16 . A method of producing a medical device of claim 1 , said method comprising:

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

providing a fabric sleeve,

at least partly covering said first loop-shaped support with said sleeve, and

forming at least a first flange by folding at least a portion of said sleeve over itself such that a double layer of opposing fabrics are formed.

17 . The device of claim 6 , wherein said second loop-shaped support comprises a second flange being connected thereto,

wherein:

said second flange 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 abuts said heart valve;

said second flange comprises a fabric sleeve covering said second loop-shaped support and

said fabric sleeve comprises a flange portion extending from said second loop-shaped support and configured to overlap a surface of, and form a collar around, at least a portion of said annulus.

18 . The device of claim 17 , wherein at least one of said first and second flanges is adapted to form a connection of at least one of the loop-shaped supports and a prosthetic valve against said annulus.

19 . The device of claim 17 , wherein at least one of said first and second flanges has an intermittent extension along a periphery of its corresponding loop-shaped support.

20 . The device of claim 17 , wherein at least one of said first and second flanges has a continuous extension along a periphery of its corresponding loop-shaped support.

21 . The device of claim 17 , wherein at least one of said first and second flanges comprises a reinforcing element.

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

inserting a medical device into said heart valve, said medical device including at least one loop-shaped support and at least one flange unit;

positioning said loop-shaped support such that it abuts a first side of the heart valve, wherein said first flange unit has a fabric sleeve covering said first loop-shaped support and

folding at least a portion of said sleeve over itself to form a double layer of opposing fabrics, such that said sleeve includes a flange portion extending from said first loop-shaped support and wherein said flange is configured to overlap a surface of and form a collar around at least a portion of said annulus,

positioning said flange unit such that it abuts said annulus; and

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

23 . The method of claim 22 , and further including the steps of:

extending said flange away from said first loop-shaped support to overlap a portion of said annulus.

24 . The method of claim 22 , wherein the device is inserted into the heart valve by using a catheter, whereupon the catheter is withdrawn leaving the device in said heart valve.

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