Devices, systems, and methods for reshaping a heart valve annulus

Abstract

Devices, systems, and methods employ an implant that is sized and configured to attach to the annulus of a dysfunctional heart valve annulus. In use, the implant extends across the major axis of the annulus above and/or along the valve annulus. The implant reshapes the major axis dimension and/or other surrounding anatomic structures. The implant restores to the heart valve annulus and leaflets a more functional anatomic shape and tension. The more functional anatomic shape and tension are conducive to coaptation of the leaflets, which, in turn, reduces retrograde flow or regurgitation. The implant improves function to the valve, without surgically cinching, resecting, and/or fixing in position large portions of a dilated annulus, or without the surgical fixation of ring-like structures.

1 . An implant to reshape a heart valve annulus comprising a body sized and configured to rest near or within a heart valve annulus, including a portion of the body contacting and outwardly displacing tissue to reshape the heart valve annulus.  
     
     
         2 . An implant to reshape a heart valve annulus comprising a body sized and configured to rest in net compression near or within a heart valve annulus, including a portion of the body contacting tissue to displace tissue to reshape the heart valve annulus.  
     
     
         3 . An implant to reshape a heart valve annulus comprising 
 a body sized and configured to rest in net compression near or within a heart valve annulus, and    spaced-apart struts appended to the body to contact tissue near or within the heart valve annulus, the struts being sized and configured to displace tissue as a result of the net compression to reshape the heart valve annulus.    
     
     
         4 . An implant to reshape a heart valve having an annulus and leaflet commissures comprising 
 a body sized and configured to rest in net compression near or within a heart valve annulus, and    spaced-apart struts appended to the body to contact tissue at or near the leaflet commissures, the struts being sized and configured to displace tissue as a result of the net compression to reshape the heart valve annulus.    
     
     
         5 . An implant to reshape a heart valve annulus comprising 
 a body sized and configured to rest in net compression near or within a heart valve annulus, and    spaced-apart struts appended to the body to contact tissue near or within the heart valve annulus, the struts being sized and configured to apply tension to tissue as a result of the compression of the body to reshape the heart valve annulus.    
     
     
         6 . An implant to reshape a heart valve having an annulus and leaflet commissures comprising 
 a body sized and configured to rest in net compression near or within the heart valve annulus, and    spaced-apart struts appended to the body to contact tissue at or near the leaflet commissures, the structures being sized and configured to apply tension to tissue at or near the leaflet commissures as a result of the compression of the body to shape and tension the heart valve annulus for leaflet coaptation.    
     
     
         7 . An implant according to  claim 1  or  2  or  3  or  4  or  5  or  6   wherein the body comprises an annular shape.    
     
     
         8 . An implant according to  claim 1  or  2  or  3  or  4  or  5  or  6   wherein the body comprises a closed annular shape.    
     
     
         9 . An implant according to  claim 1  or  2  or  3  or  4  or  5  or  6   wherein the body comprises an open annular shape.    
     
     
         10 . An implant according to  claim 1  or  2  or  3  or  4  or  5  or  6   wherein the body comprises at least one rail.    
     
     
         11 . An implant according to  claim 1  or  2  or  3  or  4  or  5  or  6   wherein the body comprises a wire-form structure.    
     
     
         12 . An implant according to  claim 1  or  2  or  3  or  4  or  5  or  6   wherein the body is collapsible for placement within a catheter.    
     
     
         13 . An implant according to  claim 1  or  2  or  3  or  4  or  5  or  6   wherein the body includes at least one cusp sized and configured to permit folding of the body without permanent deformation.    
     
     
         14 . An implant according to  claim 1  or  2  or  3  or  4  or  5  or  6   wherein the body carries a tissue in-growth material.    
     
     
         15 . An implant according to  claim 1  or  2  or  3  or  4  or  5  or  6   further including at least one structure appended to the body and being sized and configured to contact tissue at, above, or below the heart valve annulus to stabilize the body.    
     
     
         16 . An implant according to  claim 1  or  2  or  3  or  4  or  5  or  6   wherein the body is sized and configured to extend close to the annulus.    
     
     
         17 . An implant according to  claim 1  or  2  or  3  or  4  or  5  or  6   wherein the body is sized and configured to extend above the annulus.    
     
     
         18 . An implant according to  claim 1  or  2  or  3  or  4  or  5  or  6   wherein the body is sized and configured to contact tissue above the annulus.    
     
     
         19 . An implant according to  claim 1  or  2  or  3  or  4  or  5  or  6   wherein the body is sized and configured to include one portion that extends close to the annulus and another portion that extends above the annulus.    
     
     
         20 . An implant according to  claim 1  or  2  or  3  or  4  or  5  or  6   wherein the body is sized and configured to include one portion that extends close to the annulus and another portion that contacts tissue above the annulus.    
     
     
         21 . An implant according to  claim 1  or  2  or  3  or  4  or  5  or  6   wherein the body comprises an elastic material.    
     
     
         22 . An implant according to  claim 1  or  2  or  3  or  4  or  5  or  6   wherein the body comprises a plastically deformable material.    
     
     
         23 . An implant according to  claim 1  or  2  or  3  or  4  or  5  or  6   wherein the body comprises a superelastic material.    
     
     
         24 . An implant according to  claim 1  or  2  or  3  or  4  or  5  or  6   and further including a retaining element appended to the body and extending over at least a portion of a native heart valve leaflet, the restraining element being shaped to restrain retrograde movement of the heart valve leaflet.    
     
     
         25 . An implant according to  claim 1  or  2  or  3  or  4  or  5  or  6   and further including a neoleaflet element appended to the body and occupying the space of at least one native heart valve leaflet, the neoleaflet element being shaped to provide a one-way valve function.    
     
     
         26 . An implant according to  claim 1  or  2  or  3  or  4  or  5  or  6   and further including a second heart valve treatment element appended to the body to affect a heart valve function.    
     
     
         27 . An implant according to  claim 26   wherein the second heart valve treatment element includes means for supplementing, repairing, or replacing a native heart valve leaflet.    
     
     
         28 . An implant according to  claim 26   wherein the second heart valve treatment element includes means for retaining a native heart valve leaflet.    
     
     
         29 . An implant according to  claim 3  or  4  or  5  or  6   wherein at least one of the struts comprises a wire-form structure.    
     
     
         30 . An implant according to  claim 3  or  4  or  5  or  6   wherein the body and the struts each comprises a wire-form structure.    
     
     
         31 . An implant according to  claim 3  or  4  or  5  or  6   wherein at least one of the struts is collapsible onto the body.    
     
     
         32 . An implant according to  claim 3  or  4  or  5  or  6   wherein at least one of the struts carries a tissue in-growth material.    
     
     
         33 . An implant according to  claim 3  or  4  or  5  or  6   wherein at least one of the struts carries a structure sized and configured to increase a surface area of contact with tissue at, above, or below the annulus.    
     
     
         34 . A method for reshaping a heart valve annulus comprising the steps of 
 introducing an implant as defined in  claim 1  or  2  or  3  or  4  into a heart, and    displacing tissue to reshape the heart valve annulus by locating the body of the implant as defined in  claim 1  or  2  or  3  or  4  near or within a heart valve annulus.    
     
     
         35 . A method according to  claim 34   wherein the introducing step comprises using an open heart surgical procedure.    
     
     
         36 . A method according to  claim 34   wherein the introducing step comprises using a surgical procedure in which the implant is carried within a catheter.    
     
     
         37 . A method according to  claim 34   wherein the introducing step comprises using an intravascular surgical procedure.    
     
     
         38 . A method according to  claim 34   wherein the displacing tissue step comprises tethering the body of the implant as defined in  claim 1  or  2  or  3  or  4  to at least one wire while locating the body near or within a heart valve annulus.    
     
     
         39 . A method for reshaping a heart valve annulus comprising the steps of 
 introducing an implant as defined in  claim 5  into a heart, and    applying tension to reshape the heart valve annulus by locating the body of the implant as defined in  claim 5  in net compression at or near a heart valve annulus with the struts in contact with and applying tension to tissue near or within the heart valve annulus.    
     
     
         40 . A method for reshaping a heart valve having an annulus and leaflet commissures comprising the steps of 
 introducing an implant as defined in  claim 6  into a heart, and    applying tension to shape and tension the heart valve annulus for leaflet coaptation by locating the body of the implant as defined in  claim 6  in net compression at or near the leaflet commissures with the struts in contact with and applying tension to tissue at or near the leaflet commissures.    
     
     
         41 . A method according to  claim 39  or  40   wherein the introducing step comprises using an open heart surgical procedure.    
     
     
         42 . A method according to  claim 39  or  40   wherein the introducing step comprises using a surgical procedure in which the implant is carried within a catheter.    
     
     
         43 . A method according to  claim 39  or  40   wherein the introducing step comprises using an intravascular surgical procedure.    
     
     
         44 . A method according to  claim 39  or  40   wherein the applying tension step comprises tethering the body of the implant as defined in  claim 5  or  6 , respectively, to at least one wire while locating the body in compression at or near a heart valve annulus.