Annuloplasty Device

Abstract

An annuloplasty device is disclosed comprising first and second support rings having a coiled configuration in which the first and second support rings are arranged as a coil around a central axis, wherein the first and second support rings are configured to be arranged on opposite sides of native heart valve leaflets of a heart valve, a stent arranged around at least a portion of the first and/or second support ring, and wherein the stent comprises retention units. A related method of repairing a defective heart valve is also disclosed.

1 . An annuloplasty device comprising first and second support rings having a coiled configuration in which the first and second support rings are arranged as a coil around a central axis,
 wherein the first and second support rings are configured to be arranged on opposite sides of native heart valve leaflets of a heart valve,   wherein a stent is arranged around at least a portion of the first and/or second support ring, and   wherein the stent comprises retention units.   
     
     
         2 . The annuloplasty device according to  claim 1 , wherein the retention units are formed from the material of the stent, whereby the retention units are integrated with the stent. 
     
     
         3 . The annuloplasty device according to  claim 1 , wherein the retention units comprise a shape-memory material, wherein activation of the shape-memory material causes the retention units to transfer from a retracted state (p 1 ) to an expanded state (p 2 ). 
     
     
         4 . The annuloplasty device according to  claim 1 , wherein the retention units are resiliently moveable from a retracted state (p 1 ) to an expanded state (p 2 ). 
     
     
         5 . The annuloplasty device according to  claim 4 , wherein the retention units are flexible to bend from the expanded state (p 2 ) to the retracted state (p 1 ). 
     
     
         6 . The annuloplasty device according to  claim 5 , wherein the retention units are aligned essentially flush with an outer diameter (D) of the stent in the retracted state. 
     
     
         7 . The annuloplasty device according to  claim 1 , wherein the stent comprises a plurality of support elements ( 108 ) forming a stent framework of closed cells ( 122 ), wherein a first support element ( 108   a ) of the plurality of support elements of a cell ( 122 ) is movable as a retention unit ( 104 ,  104 ′) along a radial direction (R), perpendicular to a longitudinal direction (L) of the stent. 
     
     
         8 . The annuloplasty device according to  claim 1 , wherein the stent is radially contractible along a radial direction (R), perpendicular to a longitudinal direction (L) of the stent, so that the stent exerts a force (F) on the first and/or second support ring. 
     
     
         9 . The annuloplasty device according to  claim 8 , wherein the stent comprises a shape-memory material, wherein activation of the shape-memory material causes the stent to contract to a reduced diameter, along a radial direction (R), to apply said force on the first and/or second support ring. 
     
     
         10 . The annuloplasty device according to  claim 1 , wherein the stent comprises support elements configured to be contractible and expandable so that an outer diameter (D 1 , D 2 ) of the stent is variable between an expanded diameter (D 1 ) and a contracted diameter (D 2 ) while a predefined length (L 1 ) of the stent is essentially maintained. 
     
     
         11 . The annuloplasty device according to  claim 10 , wherein the support elements comprise an elongated main frame extending essentially along the longitudinal direction (L) of the stent, and
 wherein the elongated main frame defines the predefined length (L 1 ) of the stent, whereby the elongated main frame has an essentially fixed position in the longitudinal direction (L) when the outer diameter of the stent varies between the expanded diameter (D 1 ) and the contracted diameter (D 2 ).   
     
     
         12 . The annuloplasty device according to  claim 1 , comprising a cover arranged around at least a portion of the first and/or second support ring, and
 wherein the stent is arranged around at least a portion of the cover.   
     
     
         13 . The annuloplasty device according to  claim 12 , wherein the stent exerts a force onto the cover so that the cover is pinched between the stent and the first and/or second support ring. 
     
     
         14 . The annuloplasty device according to  claim 1 , wherein:
 the first support ring comprises a first posterior bow and a first anterior portion,   the second support ring comprises a second posterior bow and a second anterior portion,   the first and second posterior bows are adapted to conform to a posterior aspect of said heart valve, and the first and second anterior portions are adapted to conform to an anterior aspect of said heart valve,   the first anterior portion comprises an anterior stent, the anterior stent comprising a plurality of retention units, and   the second anterior portion comprises a smooth surface free from retention units.   
     
     
         15 . The annuloplasty device according to  claim 14 , wherein:
 the first posterior bow comprises a first posterior stent comprising a first plurality of retention units, and   the second posterior bow comprises a second posterior stent comprising a second plurality of retention units extending in a direction towards the first plurality of retention units.   
     
     
         16 . The annuloplasty device according to  claim 1 , wherein:
 the first support ring transitions to the second support ring over a transition section;   the transition section is adapted to be arranged at a commissure of the heart valve leaflets,   the first and second support rings extend in respective first and second coil planes being essentially perpendicular to the central axis, and   the transition section bends at least partly along the central axis so that the first coil plane is separated a distance (d 1 ) from the second coil plane along the central axis at the transition region.   
     
     
         17 . A method of repairing a defective heart valve comprising;
 positioning a first support ring of an annuloplasty device on a ventricular side of the heart valve,   positioning a second support ring of the annuloplasty device on an atrial side of the heart valve, whereby the first and second support rings are arranged as a coil extending through a commissure of the heart valve, the first and/or second support ring comprising a stent arranged around at least a portion of the first and/or second support ring, the stent comprising retention units, and   positioning the stent in abutment with valve tissue along said portion so that the retention units are engaged into tissue of the heart valve.   
     
     
         18 . The method according to  claim 17 , further comprising
 positioning an anterior stent on the atrial side along a first anterior portion of the first support ring,   positioning a first posterior stent on the atrial side along a first posterior bow of the first support ring, and   positioning a second posterior stent on the ventricular side along a second posterior bow of the second support ring.   
     
     
         19 . The method according to  claim 18 , further comprising
 engaging retention units of the anterior stent into valve tissue on the atrial side, and   engaging retention units of the first and second posterior stents into valve tissue on the respective atrial and ventricular side to anchor the annuloplasty device at the heart valve.   
     
     
         20 . The method according to  claim 17 , further comprising
 positioning the first and second support rings on the respective atrial and ventricular sides of the heart valve by ejecting the first and second support rings from a delivery catheter, whereby the retention units move from a retracted state (p 1 ) to an expanded state (p 2 ) as the first and second support rings are ejected from the delivery catheter.   
     
     
         21 . The method according to  claim 20 , wherein the retention units are aligned essentially flush with an outer diameter (D) of the stent in the retracted state when the first and second support rings moves along the delivery catheter.