Devices and methods for cardiac annulus stabilization and treatment

Abstract

Devices and methods generally provide enhanced stabilization, exposure and/or treatment of a cardiac valve annulus. Methods generally involve introducing a stabilizing member beneath one or more leaflets of a heart valve to engage the annulus at an intersection between the leaflets and the interior ventricular wall of the heart. Force is then applied to the stabilizing member to stabilize and/or expose the valve annulus. In some embodiments, the stabilizing member may include a series of hydraulically driven tethered anchors, such as hooks or clips, for engaging and cinching valve annulus tissue to decrease the diameter of a regurgitant valve. Alternatively, other treatments may be delivered by a stabilizing member, such as radiofrequency energy, drugs, bulking agents or shape memory stents. A second stabilizing member may also be introduced above the leaflets for further stabilization.

1 - 57 . (canceled) 
     
     
         58 . A method for stabilizing a valve annulus of a heart for performing a procedure on the valve annulus, the method comprising:
 introducing at least a first stabilizing member beneath one or more leaflets of a valve of the heart to engage the annulus at an intersection between at least one leaflet and an interior ventricular wall of the heart; and   applying force to the first stabilizing member to stabilize the valve annulus.   
     
     
         59 . A method as in  claim 58 , wherein introducing comprises passing the member beneath at least the posterior leaflet of the mitral valve of the heart. 
     
     
         60 . A method as in  claim 58 , wherein applying force to the first stabilizing member exposes the valve annulus from surrounding tissue of the heart. 
     
     
         61 . A method as in  claim 58 , wherein introducing comprises advancing an elongate catheter carrying the first stabilizing member through vasculature of a patient to the heart, wherein the first stabilizing member is adapted to change between a flexible configuration for introduction through the vasculature and a curved configuration to conform to the annulus. 
     
     
         62 . A method as in  claim 61 , further comprising changing the shape of the first stabilizing member to conform to the annulus. 
     
     
         63 . A method as in  claim 62 , wherein changing the shape of the first stabilizing member comprises articulating the stabilizing member in at least two directions. 
     
     
         64 . A method as in  claim 62 , wherein changing the shape of the first stabilizing member comprises applying tension to at least a first tensioning cord to cause a first bend in the stabilizing member. 
     
     
         65 . A method as in  claim 64 , wherein changing the shape further comprises applying tension to at least a second tensioning cord to cause a second bend in the stabilizing member. 
     
     
         66 . A method as in  claim 65 , wherein the first bend comprises approximately a C-shaped bend to conform the stabilizing member to the annulus, and the second bend comprises an upwardly directed bend. 
     
     
         67 . A method as in  claim 62 , wherein changing the shape of the first stabilizing member comprises introducing a fluid into a shape-memory stabilizing member. 
     
     
         68 . A method as in  claim 62 , further comprising locking the shape of the first stabilizing member. 
     
     
         69 . A method as in  claim 58 , wherein applying force to the first stabilizing member comprises applying upwardly directed force in a direction from the ventricles toward the atria of the heart. 
     
     
         70 . A method as in  claim 58 , wherein stabilizing further comprises introducing at least a second stabilizing member over the valve leaflets. 
     
     
         71 . A method as in  claim 70 , further comprising moving the second stabilizing member toward the first stabilizing member to further stabilize the valve annulus. 
     
     
         72 . A method for stabilizing a valve annulus of a heart for performing a procedure on the valve annulus, the method comprising:
 advancing a flexible, elongate stabilizing catheter through vasculature of a patient to the   heart;   introducing at least a first stabilizing member of the stabilizing catheter beneath one or more leaflets of a valve of the heart to engage the annulus at an intersection between at least one leaflet and an interior ventricular wall of the heart;   changing the shape of the stabilizing member to conform to the annulus; and applying force to the stabilizing member to stabilize the valve annulus.   
     
     
         73 . A method as in  claim 72 , wherein changing the shape of the first stabilizing member comprises articulating the stabilizing member in at least two directions. 
     
     
         74 . A method as in  claim 72 , wherein changing the shape of the first stabilizing member comprises applying tension to at least a first tensioning cord to cause a first bend in the stabilizing member. 
     
     
         75 . A method as in  claim 74 , wherein changing the shape further comprises applying tension to at least a second tensioning cord to cause a second bend in the stabilizing member. 
     
     
         76 . A method as in  claim 75 , wherein the first bend comprises approximately a C-shaped bend to conform the stabilizing member to the annulus, and the second bend comprises an upwardly directed bend. 
     
     
         77 . A method as in  claim 72 , wherein changing the shape of the first stabilizing member comprises introducing a fluid into a shape-memory stabilizing member. 
     
     
         78 . A method as in  claim 72 , further comprising locking the shape of the first stabilizing member. 
     
     
         79 . A method as in  claim 72 , wherein applying force to the first stabilizing member comprises applying upwardly directed force in a direction from the ventricles toward the atria of the heart. 
     
     
         80 . A method as in  claim 72 , wherein stabilizing further comprises introducing at least a second stabilizing member over the valve leaflets. 
     
     
         81 . A method as in  claim 80 , further comprising moving the second stabilizing member toward the first stabilizing member to further stabilize the valve annulus. 
     
     
         82 . A method for constricting a valve annulus in a beating heart, the method comprising:
 introducing at least a first stabilizing member beneath one or more leaflets of a valve of the heart to engage the annulus at an intersection between at least one leaflet and an interior ventricular wall of the heart of the heart;   applying force to the first stabilizing member to stabilize the valve annulus; and constricting at least a portion of the valve annulus while the valve annulus remains stabilized.   
     
     
         83 . A method as in  claim 82 , further comprising:
 introducing at least a second stabilizing member over the valve leaflets; and moving the second stabilizing member toward the first stabilizing member further stabilize the annulus.   
     
     
         84 . A method as in  claim 83 , wherein constricting comprises attaching a mechanical support structure to at least a portion of the valve annulus. 
     
     
         85 . A method as in  claim 84 , wherein the mechanical support structure comprises a ring or a system of anchors and tethers. 
     
     
         86 . A method as in  claim 83 , wherein constricting comprises applying energy to shrink at least a portion of the annular tissue. 
     
     
         87 . A method for constricting a valve annulus in a beating heart, the method comprising:
 introducing at least a first stabilizing member beneath one or more leaflets of a valve of the heart to engage the annulus at an intersection between at least one leaflet and an interior ventricular wall of the heart of the heart;   applying force to the first stabilizing member to stabilize the valve annulus;   securing individual anchors at circumferentially spaced-apart locations about at least a portion of the valve annulus while the valve annulus remains stabilized; and   cinching a tether through the anchors to circumferentially constrict the annulus.   
     
     
         88 . A method as in  claim 87 , further comprising:
 introducing at least a second stabilizing member over the valve leaflets; and   moving the second stabilizing ring toward the first stabilizing ring to further stabilize the annulus.   
     
     
         89 . A method as in  claim 88 , wherein securing the anchors comprises driving the anchors from one of the first and second stabilizing members. 
     
     
         90 . A method as in  claim 89 , wherein driving the anchors from one of the first and second members comprises inflating an expandable balloon in one of the members to force the anchors at least partially out of the member into tissue of the valve annulus. 
     
     
         91 . A method as in  claim 89 , wherein securing the anchors further comprises driving the anchors through tissue of the valve annulus into an anchor receiving piece coupled with the other of the first and second stabilizing members.