Method and apparatus for performing catheter-based annuloplasty using local plications

Abstract

A minimally invasive method of performing annuloplasty. According to one aspect, a method for performing annuloplasty includes creating a first plication in the tissue near a mitral valve of a heart, using at least a first plication element, and creating a second plication in the tissue near the mitral valve such that the second plication is substantially coupled to the first plication.

1 . A method for performing annuloplasty, the method comprising: 
 creating a first plication in the tissue near a mitral valve of a heart, the first plication being created using at least a first plication element; and    creating a second plication in the tissue near the mitral valve, wherein the second plication is substantially coupled to the first plication.    
     
     
         2 . The method of  claim 1  further including: 
 accessing a left ventricle of the heart to provide the first plication element to the left ventricle; and    engaging the first plication element to the tissue near the mitral valve, wherein engaging the first plication element includes causing the first plication element to substantially pass through a portion of the tissue to substantially anchor the first plication element to the tissue near the mitral valve.    
     
     
         3 . The method of  claim 2  wherein the first plication element is an anchor arrangement with a tail, and creating the first plication in the tissue near the mitral valve includes: 
 accessing the left ventricle of the heart to provide a second plication element to the left ventricle, the second plication element being an anchor arrangement with a tail;    engaging the second plication element to the tissue near the mitral valve, the second plication element being separated from the first plication element by a first distance, wherein engaging the second plication element includes causing the second plication element to substantially pass through the tissue to substantially anchor the second plication element to the tissue near the mitral valve; and    providing a first locker element over the tail of the first plication element and the tail of the second plication element.    
     
     
         4 . The method of  claim 3  wherein creating the second plication in the tissue near the mitral valve includes: 
 accessing the left ventricle of the heart to provide a third plication element to the left ventricle, the third plication element being an anchor arrangement with a tail;    engaging the third plication element to the tissue near the mitral valve, the third plication element being separated from the second plication element by a second distance, wherein engaging the third plication element includes causing the third plication element to substantially pass through the tissue to substantially anchor the third plication element to the tissue near the mitral valve; and    providing a second locker element over the tail of the second plication element and the tail of the third plication element.    
     
     
         5 . The method of  claim 4  wherein the first distance and the second distance are approximately the same.  
     
     
         6 . The method of  claim 2  wherein the first plication element is delivered to the left ventricle using a catheter.  
     
     
         7 . The method of  claim 5  wherein the catheter has a deflectable tip.  
     
     
         8 . The method of  claim 2  further including: 
 accessing the left ventricle using an incrementor catheter, the incrementor catheter including a first section and a second section, wherein the first section is arranged to be tracked over a tail of the first plication element.    
     
     
         9 . The method of  claim 8  further including: 
 deploying the incrementor catheter, wherein deploying the incrementor catheter includes positioning a tip of the second section at the first distance distance away from a tip of the first section.    
     
     
         10 . A method for performing annuloplasty, the method comprising: 
 accessing a heart to provide a plurality of plication elements to the heart, the plurality of plication elements being provided to the heart through a catheter arrangement, the plication elements including a first anchor arrangement;    engaging the first anchor arrangement to tissue near a mitral valve of the heart using the catheter arrangement to substantially anchor the first anchor arrangement to the tissue near the mitral valve; and    creating at least a first plication and a second plication using the first anchor arrangement.    
     
     
         11 . The method of  claim 10  wherein engaging the first anchor arrangement includes causing the first anchor arrangement to substantially pass through the tissue near the mitral valve.  
     
     
         12 . The method of  claim 11  wherein the plurality of plication elements includes a first locking element and a second locking element, and accessing the heart to provide the plurality of elements to the heart includes: 
 accessing a left ventricle of the heart to provide the first locking element to the left ventricle;    substantially deploying the first locking element over the first anchor arrangement to create the first plication; and    substantially deploying the second locking element over the first anchor arrangement to create the second plication.    
     
     
         13 . The method of  claim 12  wherein the first anchor arrangement includes a tail portion, and substantially deploying the first locking element over the first anchor arrangement includes substantially deploying the first locking element over the tail portion and substantially deploying the second locking element over the second anchor arrangement includes substantially deploying the second locking element over the tail portion.  
     
     
         14 . The method of  claim 13  wherein creating at least the first plication and the second plication using the first anchor arrangement includes: 
 applying tension to the tail portion to create the first plication using the first locking element; and    applying tension to the tail portion to create the second plication using the second locking element.    
     
     
         15 . The method of  claim 14  wherein tension is applied to the tail portion to create the first plication and to create the second plication substantially simultaneously.  
     
     
         16 . The method of  claim 10  wherein the catheter arrangement has a deflectable tip.  
     
     
         17 . A method for performing annuloplasty, the method comprising: 
 accessing an area of a heart using a catheter arrangement, the catheter arrangement including a first portion;    temporarily anchoring the first portion of the catheter arrangement to the tissue near the mitral valve of the heart;    providing an anchor element to the area; and    engaging the anchor element to the tissue near the mitral valve, wherein the first portion of the catheter arrangement is arranged to substantially provide a counter-traction force associated with engaging the anchor element.    
     
     
         18 . The method of  claim 17  wherein engaging the anchor element to the tissue near the mitral valve includes causing the anchor element to substantially pass through a portion of the tissue near the mitral valve to substantially anchor the anchor element to the tissue near the mitral valve.  
     
     
         19 . The method of  claim 18  wherein the area is a left ventricle of the heart.  
     
     
         20 . The method of  claim 19  further including: 
 substantially detaching the first portion of the catheter arrangement from the tissue near the mitral valve.    
     
     
         21 . The method of  claim 19  wherein the first portion of the catheter arrangement is a tip of the catheter arrangement.  
     
     
         22 . The method of  claim 19  wherein the first portion of the catheter arrangement is a coiled wire of the catheter arrangement.  
     
     
         23 . The method of  claim 19  wherein providing the anchor element to the left ventricle includes providing the anchor element using the catheter arrangement.  
     
     
         24 . The method of  claim 23  wherein the catheter arrangement has a deflectable tip and a pull wire arranged to deflect the deflectable tip to position one of the anchor element and the first portion.  
     
     
         25 . A method for performing annuloplasty, the method comprising: 
 accessing an area of a heart using a catheter arrangement, the catheter arrangement including a first portion;    temporarily anchoring the first portion of the catheter arrangement to the tissue near the mitral valve of the heart;    providing an anchor element to the area; and    engaging the anchor element to the tissue near the mitral valve, wherein the first portion of the catheter arrangement is arranged to substantially position a tip of the catheter arrangement at the tissue near the mitral valve.    
     
     
         26 . The method of  claim 25  wherein engaging the anchor element to the tissue near the mitral valve includes causing the anchor element to substantially pass through a portion of the tissue near the mitral valve to substantially anchor the anchor element to the tissue near the mitral valve.  
     
     
         27 . The method of  claim 26  wherein the area is a left ventricle of the heart.  
     
     
         28 . The method of  claim 27  further including: 
 substantially detaching the first portion of the catheter arrangement from the tissue near the mitral valve.    
     
     
         29 . The method of  claim 27  wherein the first portion of the catheter arrangement is the tip of the catheter arrangement.  
     
     
         30 . The method of  claim 27  wherein the first portion of the catheter arrangement is a coiled wire of the catheter arrangement.  
     
     
         31 . The method of  claim 27  wherein providing the anchor element to the left ventricle includes providing the anchor element using the catheter arrangement.  
     
     
         32 . The method of  claim 31  wherein the catheter arrangement has a deflectable tip and a pull wire arranged to deflect the deflectable tip to position one of the anchor element and the first portion.  
     
     
         33 . A method for performing annuloplasty, the method comprising: 
 accessing an area of a heart to provide a first plication element to the area using a catheter arrangement, the catheter arrangement including a first portion and a second portion;    substantially anchoring the first portion of the catheter arrangement to tissue near a mitral valve of the heart;    positioning a tip of the second portion of the catheter arrangement at a first distance from the first portion; and    substantially engaging the first anchor to the tissue near the mitral valve of the heart using the second portion of the catheter arrangement.    
     
     
         34 . The method of  claim 33  wherein substantially anchoring the first portion of the catheter arrangement to tissue near the mitral valve of the heart includes: 
 positioning the first portion of the catheter arrangement over a guide, the guide being substantially anchored to the tissue near the mitral valve.    
     
     
         35 . The method of  claim 33  wherein the first anchor includes a tail, the method further including: 
 substantially unanchoring the first portion of the catheter arrangement from tissue near a mitral valve of the heart;    positioning the first portion of the catheter arrangement over the tail;    positioning the tip of the second portion of the catheter arrangement at a second distance from the first portion; and    substantially engaging a second anchor to the tissue near the mitral valve of the heart using the second portion of the catheter arrangement.    
     
     
         36 . The method of  claim 35  further including: 
 creating a plication using at least the first anchor and the second anchor.    
     
     
         37 . A method for performing annuloplasty, the method comprising: 
 accessing an area of a heart to provide a first plication element to the area using a catheter arrangement, the catheter arrangement including a deflectable tip area and a pull wire arranged to cause the deflectable tip area to deflect;    altering a curvature in the tip area to reach tissue near a mitral valve of the heart, wherein altering the curvature includes substantially actively controlling the pull wire; and    engaging the first plication element to the tissue near the mitral valve.    
     
     
         38 . The method of  claim 37  wherein engaging the first plication element includes causing the first plication element to substantially pass through a portion of the tissue to substantially anchor the first plication element to the tissue near the mitral valve.  
     
     
         39 . The method of  claim 38  wherein the area is a left ventricle of the heart.  
     
     
         40 . The method of  claim 38  wherein the catheter arrangement is a hook catheter arrangement, the tip area being substantially shaped as a hook.  
     
     
         41 . The method of  claim 40  wherein the catheter arrangement further includes a temporary anchor, and the method further includes: 
 deploying the temporary anchor; and    substantially temporarily anchoring the temporary anchor to the tissue near the mitral valve.    
     
     
         42 . The method of  claim 41  wherein the method further includes: 
 unanchoring the temporary anchor from the tissue near the mitral valve.    
     
     
         43 . The method of  claim 40  further including: 
 deploying an anchor element through the catheter arrangement; and    anchoring the anchor element to the tissue near the mitral valve.    
     
     
         44 . A method for performing annuloplasty, the method comprising: 
 accessing an area of a heart using a catheter arrangement, the catheter arrangement including a deflectable tip portion and a pull wire arranged to cause the deflectable tip area to deflect;    altering a curvature in the tip area to reach tissue near a mitral valve of the heart, wherein altering the curvature includes substantially actively controlling the pull wire to position the tip area; and    temporarily engaging the tip area to the tissue near the mitral valve, wherein temporarily engaging the tip area to the tissue near the mitral valve enables the catheter arrangement to deliver at least a first plication element to the tissue near the mitral valve.    
     
     
         45 . The method of  claim 44  further including engaging the first plication element to the tissue near the mitral valve, wherein engaging the first plication element includes causing the first plication element to substantially pass through a portion of the tissue to substantially anchor the first plication element to the tissue near the mitral valve.  
     
     
         46 . The method of  claim 45  wherein the area is a left ventricle of the heart.  
     
     
         47 . The method of  claim 45  wherein the catheter arrangement is a hook catheter arrangement, the tip area being substantially shaped as a hook.  
     
     
         48 . A method for performing annuloplasty, the method comprising: 
 accessing a left ventricle of a heart to provide a first plication element to the left ventricle using a catheter arrangement;    creating a curvature in the catheter arrangement to reach tissue near a mitral valve of the heart, the curvature being at an orthogonal orientation with respect to the mitral valve; and    engaging the first plication element to the tissue near the mitral valve, wherein engaging the first plication element includes causing the first plication element to substantially pass through a portion of the tissue to substantially anchor the first plication element to the tissue near the mitral valve.    
     
     
         49 . The method of  claim 48  wherein creating the curvature includes creating approximately a 180 degree curve in the catheter arrangement.  
     
     
         50 . The method of  claim 48  further including: 
 accessing the left ventricle using an incrementor catheter, the incrementor catheter including a first section and a second section, wherein the first section is arranged to be tracked over a tail of the first plication element.    
     
     
         51 . The method of  claim 50  further including: 
 deploying the incrementor catheter, wherein deploying the incrementor catheter includes positioning a tip of the second section at a distance away from a tip of the first section.    
     
     
         52 . The method of  claim 51  further including: 
 engaging a second plication element to the tissue at approximately the distance away from the first plication element using the second section.    
     
     
         53 . The method of  claim 52  further including: 
 creating a plication using the first plication element and the second plication element.    
     
     
         54 . An incrementor catheter comprising: 
 a first lumen, the first lumen being arranged to track over a wire, the wire being substantially anchored within a left ventricle of a heart; and    a second lumen, the second lumen having a second tip that is arranged to be moved at a distance away from a first tip of the first lumen, wherein the second lumen is arranged to carry and to deploy a plication element.    
     
     
         55 . A method for performing annuloplasty comprising: 
 temporarily fixing a helical coil of a first element in tissue near a mitral valve of the heart, the first element including a tail; and    tracking a catheter arrangement over the tail, wherein the catheter arrangement is arranged to substantially permanently fix a second element to the tissue.    
     
     
         56 . The method of  claim 55  wherein the catheter arrangement is an incrementor catheter.  
     
     
         57 . The method of  claim 55  wherein temporarily fixing the helical coil of the first element includes using one of an L-shaped catheter and a hook catheter to temporarily fix the helical coil.  
     
     
         58 . An incrementor catheter comprising: 
 a main catheter, and first and second distal catheter portions coupled with the main catheter, the first and second distal catheter portions having respective first and second lumens,    the second distal catheter portion arranged to be moved laterally a first distance away from the first distal catheter portion,    an elongate guide member receivable in the first lumen, and    a first plication element receivable in and deployable from the second lumen.    
     
     
         59 . The incrementor catheter of  claim 58 , wherein the elongate guide member further comprises a guide wire.  
     
     
         60 . The incrementor catheter of  claim 58 , wherein the elongate guide member further comprises a tether coupled with a tissue anchor.  
     
     
         61 . The incrementor catheter of  claim 60 , wherein the tissue anchor further comprises a temporary anchor.  
     
     
         62 . The incrementor catheter of  claim 60 , wherein the tissue anchor further comprises a second plication element.  
     
     
         63 . The incrementor catheter of  claim 62 , wherein the first and second plication elements are T-bars.  
     
     
         64 . The incrementor catheter of  claim 62  further comprising a locker configured to couple the first and second plication elements together.