System, device and method for reshaping a valve annulus

Abstract

A valve annulus repair system joins anchors at one or both of their proximal and distal ends to construct an implant to reshape the annulus. A removable frame may be used to position the anchors proximate to the annulus and to adjust the shape of the annulus. The frame may support the anchors during deployment of the system, release the anchors during construction of the implant, adjust the shape of the implant (and concomitantly the shape of the reconstructed valve) during an adjustment/cinching process, retain the adjusted shape of the valve annulus while relative anchor positions are secured, and release the anchors to enable the frame to be removed from the deployment site following implant construction. With such a system, a low-profile, flexile annular valve implant with reduced the risks of migration, fracture, embolism and thrombus may be provided.

What is claimed is: 
     
         1 . An implant comprising:
 a plurality of anchors, each anchor comprising a distal end sharpened for advancement through tissue and towards another of the plurality of anchors, each anchor configured for mating engagement with the another of the plurality of anchors when embedded in tissue to form a conjoined anchor pair; and   a binding mechanism, coupling proximal ends of at least two anchors, to retain the at least two anchors in a predetermined configuration.   
     
     
         2 . The implant of  claim 1 , wherein the anchors are configured for advancement through tissue of a valve annulus and are each configured for mating engagement with the another of the plurality of anchors when embedded in the tissue of the valve annulus to form a conjoined anchor pair. 
     
     
         3 . The implant of  claim 2 , wherein the predetermined configuration is a valve annulus reshaping configuration. 
     
     
         4 . The implant of  claim 1 , wherein the binding mechanism comprises one or more of a cord, a wire, a filament, and a clip. 
     
     
         5 . The implant of  claim 4 , wherein each anchor comprises a proximal end comprising an anchor head, and wherein the binding mechanism couples together at least some of the anchor heads of the plurality of anchors. 
     
     
         6 . The implant of  claim 5 , wherein the conjoined anchor pair comprises an anchor lumen extending at least partially therethrough, and wherein the binding mechanism couples a pair of anchor heads using a path including the anchor lumen. 
     
     
         7 . The implant of  claim 1 , wherein each anchor comprises a proximal end comprising an anchor head, and wherein the binding mechanism couples together at least some of the anchor heads of the plurality of anchors. 
     
     
         8 . The implant of  claim 7 , wherein the conjoined anchor pair comprises an anchor lumen extending at least partially therethrough, and wherein the binding mechanism couples a pair of anchor heads using a path including the anchor lumen. 
     
     
         9 . The implant of  claim 1 , wherein the conjoined anchor pair comprises an anchor lumen extending at least partially therethrough, and wherein the binding mechanism couples a pair of anchors using a path including the anchor lumen. 
     
     
         10 . The implant of  claim 1 , wherein the conjoined anchor pair comprises a pair of helical coil anchors. 
     
     
         11 . An implant comprising:
 a frame;   a plurality of anchors supported by the frame, each anchor comprising a proximal end comprising an anchor head, and a distal end configured for mated engagement with another anchor of the plurality of anchors to form a conjoined anchor pair, each anchor comprising an anchor lumen extending from a proximal anchor end to a distal anchor end; and   a guidance device axially translatable within the anchor lumen and through tissue, the guidance device configured to define a path through tissue from a first anchor towards a second anchor, the first anchor translatable over the guidance device along the path through the tissue towards the second anchor to form a conjoined anchor pair.   
     
     
         12 . The implant of  claim 11 , wherein the tissue is tissue of a valve annulus, and the frame is shiftable between a first configuration enabling positioning of the frame at least partially around a valve annulus, and a second configuration different from the first configuration to reshape the valve annulus. 
     
     
         13 . The implant of  claim 11 , wherein the guidance device comprises a curved distal end configured to direct the anchor away from a plane normal to the tissue. 
     
     
         14 . The implant of  claim 13 , wherein the anchors are translatable past the curved distal end of the guidance device. 
     
     
         15 . The implant of  claim 14 , wherein the guidance device comprises at least one of a guide-wire or a guide tube. 
     
     
         16 . The implant of  claim 11 , wherein the guidance device comprises at least one of a guide-wire or a guide tube. 
     
     
         17 . The implant of  claim 11 , wherein the frame comprises a plurality of anchor sleeves corresponding in number to the plurality of anchors, each anchor sleeve configured to releasably support an associated anchor for deployment into tissue. 
     
     
         18 . The implant of  claim 11 , wherein the plurality of anchors comprises a plurality of helical coils, and wherein the conjoined anchor pair comprises a plurality of overlapping coils of a helical coil pair. 
     
     
         19 . A method for reshaping a valve annulus, the method comprising:
 deploying an expandable frame releasably supporting a plurality of anchors through a delivery catheter to a valve annulus repair site;   driving at least two of the plurality of anchors into tissue around the valve annulus including matingly engaging distal tips of anchors to form an anchor pair at least partially around the valve annulus;   compressing the expandable frame to reshape the valve annulus to an annular reshaping configuration;   binding proximal ends of anchor pairs;   releasing the plurality of anchors from the expandable frame; and   removing at least a portion of the expandable frame from the valve annulus repair site.   
     
     
         20 . The method of  claim 19 , wherein driving the plurality of anchors into tissue around the valve annulus further comprises, for each pair of anchors of the plurality of anchors:
 selecting an anchor including identifying a paired anchor;   inserting a guidance device through a first lumen extending from a proximal end of the delivery catheter through a distal anchor tip of the selected anchor, wherein the guidance device comprises a curve at a distal tip configured to guide the selected anchor to the paired anchor and wherein inserting the guidance device through the distal anchor tip of the selected anchor cuts a first path through tissue towards the paired anchor;   advancing the selected anchor over the guidance device towards the anchor pair;   inserting a guidance device through a second lumen extending from a proximal end of the catheter through a distal anchor tip of the paired anchor, wherein the curve at a distal tip of the guidance device cuts a path through tissue towards the selected anchor; and   advancing one or both of the selected anchor and the paired anchor towards each other to conjoin distal ends of the selected anchor and the paired anchor.