Valve translocation device and method for the treatment of functional valve regurgitation

Abstract

The present invention provides devices for treating functional mitral regurgitation and methods of use thereof. The devices translocate a subject's mitral valve in an apical direction. The devices thereby treat mitral regurgitation while preserving a subject's original mitral valve and chordae tendinae.

1 . An apparatus comprising:
 a ring-shaped body having an annulus portion and a leaflet portion axially spaced from the annulus portion,   the annulus portion having an annulus end having a perimeter and being configured to be attached to an annulus of a native heart valve from which a leaflet of the native heart valve has been separated,   the leaflet portion having a leaflet end having a perimeter equal to or larger than the annulus portion perimeter and being configured to be attached to the native heart valve leaflet and thereby to connect the native heart valve leaflet to the native heart valve annulus.   
     
     
         2 . The apparatus of  claim 1 , wherein the leaflet portion of the ring-shaped body includes a pleat having an expandable portion extending to the leaflet end of the ring-shaped body to define in part the perimeter of the leaflet end and a fixed portion spaced from the leaflet end, the expandable portion of the pleat being configured to be attached to the native heart valve leaflet. 
     
     
         3 . The apparatus of  claim 2 , wherein:
 the pleat is a first pleat,   the expandable portion of the first pleat is configured to be attached to the leaflet,   the leaflet portion of the ring-shaped body includes a second pleat having an expandable portion extending to the leaflet end of the ring-shaped body further to define in part the perimeter of the leaflet end and a fixed portion spaced from the leaflet end, the expandable portion of the second pleat being configured to be attached to the leaflet.   
     
     
         4 . The apparatus of  claim 1 , wherein:
 the leaflet end of the ring-shaped body has a first circumferential portion having a thickness and a second circumferential portion have a thickness different from the thickness of the first circumferential portion.   
     
     
         5 . The apparatus of  claim 4 , wherein:
 the native heart valve leaflet is a first leaflet from a plurality of native heart valve leaflets that have been separated from the native heart valve,   the first leaflet having a first thickness and a second leaflet from the plurality of native heart valve leaflets having a second thickness, the first thickness being greater than the second thickness, and   the thickness of the first circumferential portion being approximately equal to the first thickness and the thickness of the second circumferential portion being approximately equal to the second thickness.   
     
     
         6 . The apparatus of  claim 5 , wherein the native heart valve is a mitral valve, the first leaflet is an anterior leaflet and the second leaflet is a posterior leaflet. 
     
     
         7 . The apparatus of  claim 1 , wherein the annulus end has a thickness greater than a thickness of the remainder of the annulus portion. 
     
     
         8 . The apparatus of  claim 7 , wherein the annulus portion is formed of a sheet of material, the annulus end is integrally formed with the remainder of the annulus portion with multiple layers of the sheet of material. 
     
     
         9 . The apparatus of  claim 8 , wherein the annulus end is formed by rolling the sheet of material. 
     
     
         10 . The apparatus of  claim 7 , wherein the annulus end is formed separately from, and coupled to, the annulus portion. 
     
     
         11 . The apparatus of  claim 1 , wherein the ring-shaped body is formed of biological tissue. 
     
     
         12 . The apparatus of  claim 11 , wherein the biological tissue is human or bovine pericardial tissue. 
     
     
         13 . The apparatus of  claim 1 , wherein the ring-shaped body is formed of at least one of decellularized tissue, polymer, or artificial fabric. 
     
     
         14 . The apparatus of  claim 1 , wherein the annulus portion has a thickness different from the leaflet portion. 
     
     
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         28 . An apparatus comprising:
 a ring-shaped body having an annulus portion and a leaflet portion axially spaced from the annulus portion,   the annulus portion having an annulus end and being configured to be attached to an annulus of a native heart valve from which a leaflet of the native heart valve has been separated,   the leaflet portion having a leaflet end including a pleat having an expandable portion extending to the leaflet end and a fixed portion spaced from the leaflet end, the expandable portion of the pleat being configured to be attached to the native heart valve leaflet and thereby to connect the native heart valve leaflet to the native heart valve annulus.   
     
     
         29 . The apparatus of  claim 28 , wherein the expandable portion of the pleat has a first configuration in which the leaflet end has a first perimeter and a second, expanded configuration, in which the leaflet end has a second perimeter greater than the first perimeter. 
     
     
         30 . The apparatus of  claim 29 , wherein the annulus end has a perimeter, and the leaflet end has a perimeter equal to or greater than the annulus end perimeter when the expandable portion of the pleat is in its second, expanded configuration. 
     
     
         31 . The apparatus of  claim 29 , wherein the annulus end has a perimeter, and the leaflet end has a perimeter less than the annulus end perimeter when the expandable portion of the pleat is in its second, expanded configuration. 
     
     
         32 . A translocation collar device comprising:
 a substantially ring-shaped band of material having a first edge, a second edge opposite from the first edge, and a width in between;   wherein the collar device is attachable to a circumferentially separated valve such that the first edge is attached to a valve annulus and the second edge is attached to a valve perimeter to translocate the valve in an apical direction.   
     
     
         33 . The device of  claim 32 , wherein the first edge or the second edge has a diameter between about 20 mm and 60 mm. 
     
     
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