Medical System for Annuloplasty

Abstract

An annuloplasty device is disclosed for treating a defective mitral valve having an annulus, comprising a removable and flexible elongate displacement unit for temporary insertion into a coronary sinus (CS) adjacent the valve, wherein the displacement unit has a delivery state for delivery into the CS, and an activated state to which the displacement unit is temporarily and reversibly transferable from said delivery state, the displacement unit comprises a proximal reversibly expandable portion, a distal anchoring portion being movable in relation to the proximal expandable portion in a longitudinal direction of the displacement unit to said activated state in which the shape of the annulus is modified to a modified shape, wherein the proximal expandable portion is reversibly foldable to an expanded state for positioning against a tissue wall at the entrance of the CS, and wherein the distal anchoring portion comprises an inflatable unit.

1 . An annuloplasty device for treating a defective mitral valve having an annulus, said annuloplasty device comprising:
 a removable and flexible elongate displacement unit for temporary insertion into a coronary sinus adjacent the valve, wherein the displacement unit has a delivery state for delivery into the coronary sinus and an activated state to which the displacement unit is temporarily and reversibly transferable from said delivery state,   wherein the displacement unit comprises:   a proximal expandable portion being reversibly foldable to an expanded state;   a distal anchoring portion comprising an inflatable unit and being movable in relation to the proximal expandable portion in a longitudinal direction of the displacement unit to said activated state, wherein a distance between the proximal expandable portion and the distal anchoring portion in the longitudinal direction decreases to a reduced distance when the displacement unit is transferred from the delivery state to the activated state;   a lumen extending in the longitudinal direction and having a distal opening arranged distally of the inflatable unit; and   at least one proximal opening arranged between the inflatable unit and the proximal expandable portion.   
     
     
         2 . The annuloplasty device according to  claim 1 , further comprising a guide wire arranged to extend inside the lumen and to exit the lumen at the distal opening. 
     
     
         3 . The annuloplasty device according to  claim 1 , comprising an inflation lumen connected to inflatable unit and configured to deliver an inflation medium to the inflatable unit. 
     
     
         4 . A medical system for treating a defective mitral valve having an annulus, said medical system comprising:
 the annuloplasty device of  claim 1  and an annuloplasty implant for permanent fixation at the mitral valve annulus, wherein said annuloplasty implant comprises a helix-shaped loop structure, configured to be positioned on either side of said mitral valve to retain a modified shape of the annulus caused by the movement of the distal anchoring portion anchored in the coronary sinus toward the reversibly expandable portion.   
     
     
         5 . A method for treating a defective mitral valve having an annulus, said method comprising:
 temporarily inserting a flexible, elongate displacement unit in a delivery state into a coronary sinus adjacent to the mitral valve,   anchoring a proximal expandable portion of said displacement unit,   anchoring a distal anchoring portion of said displacement unit comprising an inflatable unit inside the coronary sinus by expanding the inflatable unit, and   activating the displacement unit to an activated state by moving the distal anchoring portion in a longitudinal direction of the displacement unit to reduce a distance between the distal anchoring portion and the proximal expandable portion such that the shape of the annulus is modified to a modified shape,   wherein the displacement unit comprises a lumen extending in the longitudinal direction and having a distal opening arranged distally of the inflatable unit, and at least one proximal opening arranged between the inflatable unit and the proximal expandable portion.   
     
     
         6 . The method according to  claim 5 , further comprising:
 fixating an annuloplasty implant at the mitral valve annulus having the modified shape, wherein said annuloplasty implant comprises a helix-shaped loop structure positioned on either side of the valve to retain the modified shape of the annulus and at least a portion of said helix-shaped loop structure conforms to a curvature of said annulus, and   removing the elongate displacement unit after said fixating said annuloplasty implant.   
     
     
         7 . The method according to  claim 5 , further comprising guiding the elongate displacement unit along a guide wire arranged to extend inside the lumen of the elongate displacement unit, wherein the guide wire exits the lumen at the distal opening. 
     
     
         8 . The method according to  claim 5 , wherein anchoring the distal anchoring portion comprises inflating the inflatable unit in the great cardiac vein and/or, in the anterior interventricular branch or vein, and/or in the posterior vein and/or in the posterior ventricular vein of the heart.