Methods and devices for heart valve repair

Abstract

A system for reshaping a valve annulus includes an elongate template having a length along a longitudinal axis and at least one concavity in a generally lateral direction along said length. The pre-shaped template is positioned against at least a region of an inner peripheral wall of the valve annulus, and at least one anchor on the template is advanced into a lateral wall of the valve annulus to reposition at least one segment of the region of the inner peripheral wall of the valve annulus into said concavity. In this way, a peripheral length of the valve annulus can be foreshortened and/or reshaped to improve coaption of the valve leaflets and/or to eliminate or decrease regurgitation of a valve.

What is claimed is: 
     
         1 . A stent prosthesis for valve repair or replacement comprising:
 a scaffold comprising patterned structural elements, said stent being expandable from a crimped configuration to an expanded configuration and having sufficient strength to support a body annulus in the expanded configurations, wherein the scaffold comprises at least one circumferential ring comprising struts and crowns, wherein at least one strut in said at least one ring comprises at least one separation region and wherein said at least one separation region comprises a male-female junction and a biodegradable polymer and/or adhesive, said separation region being held together in the crimped configuration and is configured to separate after expansion of the stent under physiologic environment; and   at least one valve configured to be coupled to said at least one ring, said valve allowing blood to flow in one direction during the cardiac cycle.   
     
     
         2 . An implant for reshaping a valve annulus, said implant comprising:
 a pre-shaped metallic template having a length in an axial direction and at least one concavity in a lateral direction along said length, said concavity having a concave surface configured to be positioned adjacent to a peripheral wall of the valve annulus; and   at least one anchor configured to be coupled to the pre-shaped metallic template and to draw at least one segment of said peripheral wall of the valve annulus into said concavity to thereby reduce a diameter of said annulus in a radially inward direction, wherein said template is deployable to said pre-shaped configuration from a crimped configuration.   
     
     
         3 . The implant of  claim 2 , wherein the pre-shaped metallic template has a single concavity with a pair of opposed legs disposed about a lateral axis and joined by a curved junction region. 
     
     
         4 . The implant of  claim 2 , wherein each of the opposed legs each have a convex surface which is axially and laterally spaced-apart from the concavity and wherein the at least one anchor on the template is further configured to draw adjacent segments of said peripheral wall of the valve annulus against the convex surfaces. 
     
     
         5 . The implant of  claim 4 , further comprising an anchor on each of the convex surfaces of the opposed legs. 
     
     
         6 . The implant of  claim 2 , wherein the pre-shaped metallic template has at least two concavities separated by a convexity. 
     
     
         7 . The implant of  claim 6 , wherein each concavity has at least one anchor configured to draw at least one segment of said peripheral wall of the valve annulus into said concavity. 
     
     
         8 . The implant of  claim 2 , wherein the at least one region comprises all or a portion of a posterior mitral valve annulus. 
     
     
         9 . The implant of  claim 2 , wherein the pre-shaped metallic template comprises an elongate structure having a length in a range from 10 mm to 30 mm. 
     
     
         10 . The implant of  claim 9 , wherein the width of the concavity is in a range from 1 to 5 times the depth of the concavity. 
     
     
         11 . The implant of  claim 2 , wherein the at least one anchor comprises a helical anchor having a distal end and a proximal end, said distal end having a sharpened tip, and said proximal end being rotatably secured in the concavity of the template. 
     
     
         12 . The implant of  claim 2 , wherein the anchor is configured to be coupled to the tissue while the template is coupled to the anchor. 
     
     
         13 . The implant of  claim 2 , wherein the anchor is configured to be coupled to the tissue before the anchor is coupled to the template. 
     
     
         14 . A system comprising:
 the implant of  claim 11 ; and   a driver configured to detachably attach to and rotate the helical anchor to drive the distal tip of the helical anchor into the annulus and draw at least a segment of an inner surface of the annulus into the concavity.   
     
     
         15 . The system of  claim 14  wherein the template is slidably coupled to the detachable driver and can be moved distally relative to the detachable driver to couple with the anchor. 
     
     
         16 . The system of  claim 14  wherein the template is rotatably coupled to the anchor. 
     
     
         17 . A method for reshaping a valve annulus, said method comprising:
 delivering in a crimped configuration a metallic implantable template having a tissue-engaging surface pre-shaped with at least one concavity;   expanding said template with an open end of the at least one concavity oriented against a peripheral surface of the valve annulus, and   drawing at least one segment of the peripheral surface of the valve annulus into the concavity to reduce a diameter of said valve annulus.   
     
     
         18 . The method of  claim 17 , wherein drawing at least one segment of the peripheral surface of the valve annulus into the concavity aligns the template with the valve annulus. 
     
     
         19 . The method of  claim 17 , wherein drawing at least one segment of the peripheral surface of the valve annulus into the concavity comprises engaging an anchor against the annulus segment to apply tension or compression to draw said annulus segment into said concavity. 
     
     
         20 . The method of  claim 19 , wherein the anchor comprises a helical coil and drawing comprises rotating the helical coil to penetrate the peripheral surface of the valve annulus. 
     
     
         21 . The method of  claim 20 , wherein the helical coil is detachably attached to a driver and rotating the helical coil comprises rotating the driver. 
     
     
         22 . The method of  claim 21 , wherein the metallic implantable template is slidably coupled to said driver and said method further comprises applying tension to said driver and said helical coil to draw said annulus segment into said concavity. 
     
     
         23 . The method of  claim 22 , further comprising locking the template to the helical coil after the annulus segment has been drawn into said concavity. 
     
     
         24 . The method of  claim 21 , wherein the driver is advanced and rotated to implant the helical coil in the valve annulus, the template is advanced over the driver and coupled to the helical coil after the coil has been implanted in the valve annulus, and the driver is detached from the coil after the template has been advanced over the shaft and coupled to the coil. 
     
     
         25 . The method of  claim 17 , wherein the anchor comprises a helical coil rotatably attached to the template and drawing comprises rotating the helical coil so that the tissue is drawn into the concavity while the anchor remains attached to the template. 
     
     
         26 . The method of  claim 17 , wherein template is constrained in the crimped configuration and expanding comprises releasing the template from constraint. 
     
     
         27 . The method of  claim 17 , wherein the peripheral surface includes at least a portion of a mitral valve annulus, tricuspid valve annulus, an aortic valve annulus, or a pulmonary valve annulus. 
     
     
         28 . The method of  claim 17 , wherein drawing consists of drawing a single segment of the peripheral surface of the annulus into a single concavity on a single template. 
     
     
         29 . The method of  claim 17 , wherein drawing comprises drawing at least two segments of the peripheral surface of the annulus into at least two concavities on a single template. 
     
     
         30 . The method of  claim 17 , wherein engaging the template against the peripheral surface of the valve annulus comprises intravascularly advancing the template.