Device and Method for Improving the Function of a Heart Valve

Abstract

A device and method for improving the function of a heart valve involves insertion of a device having a first and a second shape into the heart valve. Two contact points of the device in the first shape are separated by a distance essentially corresponding to a distance between two commissures of the heart valve and separated by an increased distance in the second shape. The device is inserted into the heart valve to establish a contact between the contact points and the commissures and transformed from the first shape to said second shape in abutment with valve tissue throughout a cycle of heart action. The device may change the shape of the heart valve by stretching it between the commissures for improving the ability of the heart valve to close.

1 - 5 . (canceled) 
     
     
         6 . A method for improving the function of a heart valve comprised of valve tissue including an annulus, leaflets and at least a first commissure and a second commissure between adjacent leaflets, said method comprising:
 inserting a device in a first shape into the heart valve, said device comprising an elongate part comprising a first contact point and a second contact point;   establishing contact between the first contact point and the valve tissue at said first commissure and establishing contact between the second contact point and the valve tissue at said second commissure;   causing a change in shape of the device from said first shape to a second shape such that a distance between the first and second contact points of the device is increased and the elongate part is less arcuate between the first contact point and the second contact point in the second shape and, consequently, a distance between the first and second commissures of the heart valve is increased to stretch the opening of the heart valve and change the shape of the heart valve such that free edges of the leaflets are brought closer together in a remodeled shape;   attaching a fixation device to a portion of the device arranged to receive the fixation device, to attach the device to the valve tissue; and   causing said device, along its length, to contact the valve tissue throughout a cycle of heart action so that said length of said device is encapsulated with valve tissue over time.   
     
     
         7 . The method of  claim 6 , comprising causing the elongate part, when the device is in the second shape, to extend along the valve tissue substantially in a plane of the annulus. 
     
     
         8 . The method of  claim 6 , wherein said causing of the change in shape of the device comprises releasing a restraint on the device. 
     
     
         9 . The method of  claim 6 , comprising extending a restraining wire between portions of the elongate part to keep the first contact point and the second contact point at a maximum distance from each other in the first shape. 
     
     
         10 . The method of  claim 6 , wherein said causing of the transfer of shape of the device comprises activating a shape memory of the device. 
     
     
         11 . The method of  claim 10 , wherein the device comprises a shape-memory material and the method comprises heating the device above a transition temperature, whereby the device transforms into an austenitic state and assumes the second shape as a programmed shape. 
     
     
         12 . The method of  claim 6 , wherein the change in shape of the device from the first shape to the second shape creates a 40% increase in the distance between the first and second contact points for remodeling the heart valve. 
     
     
         13 . The method of  claim 6 , comprising attaching a suture or clip as a fixation device to said portion of the device. 
     
     
         14 . The method of  claim 6 , wherein the portion arranged to receive the fixation device is arranged at the contact points. 
     
     
         15 . The method of  claim 6 , comprising arranging the fixation device on the device so that the fixation device penetrates into valve tissue for attaching the device to the valve tissue and fix the device in the second shape. 
     
     
         16 . The method of  claim 6 , comprising arranging any of hook-shapes, protrusions, barbs, or spikes, in the tissue to attach the device. 
     
     
         17 . The method of  claim 6 , comprising arranging the elongate part, in the second shape, in a form that corresponds to at least a part of the annulus. 
     
     
         18 . The method of  claim 6 , comprising arranging the elongate part to extend along the valve tissue in a plane of the annulus while the first and second contact points are arranged in contact with the first and second commissures. 
     
     
         19 . The method of  claim 6 , wherein the device is ring-formed to extend mainly along the annulus of the heart valve. 
     
     
         20 . The method according to  claim 19 , wherein the ring form deviates from the shape of the annulus at the commissures for allowing contact between the device and the commissures. 
     
     
         21 . The method of  claim 6 , comprising placing the device in contact with the chordae of the heart valve such that the device abuts a ventricular side of the heart valve. 
     
     
         22 . The method of  claim 6 , wherein the device is resilient such that, when deformed into the first shape, an internal force strives to assuming the second shape. 
     
     
         23 . The method of  claim 6 , wherein the device is flexible in its second shape to allow movements of the annulus and the first and second commissures during heart action while still keeping the first and second commissures stretched apart in the remodeled shape.