Device And Method For Improving Fixation Of A Medical Device

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. A first flange unit is may be configured as a fabric sleeve covering the loop-shaped support. A portion of the fabric sleeve forms a flange that is attached to the annulus when said first loop-shaped support is abutting said heart valve. The flange is provideable by folding at least a portion of said sleeve over itself for forming a double layer of opposing fabrics thereof, such that said sleeve comprises a flange portion extending from said first loop-shaped support configured to overlap a surface of and form a collar around, at least a portion of said annulus.

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.