Method and system for plicating tissue in a minimally invasive medical procedure for the treatment of mitral valve regurgitation

Abstract

A system and method for the treatment of mitral valve regurgitation by reshaping the mitral valve annulus using one or more plications of annular or adjacent tissue each fixed by a retainer is described. The system includes four devices to achieve such percutaneous direct plication annuloplasty. The first is a crossing catheter having a prolapseable or curved tip. Second, a deflecting guide catheter is used to provide a means for guiding the plication device into proper position at the subvalvular region of the mitral valve annulus. Third, the plication device is then used to make plications in the subvalvular region of the mitral valve annulus. Fourth, a “C” shaped retainer with deformable ends is deployed by the plication device in order to retain the plicated tissue in the plicated form.

What is claimed is: 
     
         1 . A system for the treatment of mitral valve regurgitation through direct plication annuloplasty of a patient comprising:
 a deflecting guide catheter having an elongate body with lumen therethrough ending in a distal opening for insertion through the aortic valve into the left ventricle of the patient;   a plication device having a set of opposing jaws operable to plicate tissue in the mitral valve of the patient;   wherein the plication device comprises at least one retainer for retaining plications in tissue.   
     
     
         2 . The system of  claim 1  further comprising a crossing catheter having a distal end for insertion through the aortic valve into the left ventricle of the patient; 
     
     
         3 . The system of  claim 1  further comprising a guidewire for use in guiding the crossing catheter through the vasculature of the patient and into the left ventricle. 
     
     
         4 . The system of  claim 1  wherein the crossing catheter has a J-shaped distal tip. 
     
     
         5 . The system of  claim 1  wherein the crossing catheter has a pigtail-shaped distal tip. 
     
     
         6 . The system of  claim 1  wherein the deflecting guide catheter has a first puller wire attached to a first anchor band near the distal end of the deflecting guide catheter for deflecting the distal end of the deflecting guide catheter in response to proximal movement of the puller wire. 
     
     
         7 . The system of  claim 6  further comprising a second puller wire for a second anchor band near the distal end of the deflecting guide catheter for deflecting the distal end of the deflecting guide catheter in response to proximal movement of the second puller wire. 
     
     
         8 . The system of  claim 7  wherein the proximal movement of the second puller wire causes the deflecting guide catheter to deflect in a different plane from the deflection caused by proximal movement of the first puller wire. 
     
     
         9 . The system of  claim 8  wherein the second puller wire attaches to the second anchor band at a position that is spaced radially apart from the position at which the first puller wire attaches to the first anchor band. 
     
     
         10 . The system of  claim 1  wherein the plication device has an elongate tubular body comprised of metal with a pattern cut through the metal. 
     
     
         11 . The system of  claim 10  wherein the pattern is a dovetail pattern. 
     
     
         12 . The system of  claim 10  wherein the pattern is a helical pattern. 
     
     
         13 . The system of  claim 10  wherein a proximal section of the elongate tubular body of the plication device is comprised of nitinol and a distal section of the elongate tubular body is comprised of stainless steel. 
     
     
         14 . The system of  claim 1  wherein the retainer is “c” shaped and comprises two prongs having ends connected by an intermediate member. 
     
     
         15 . The method of  claim 14  wherein the retainer is comprised of a metal alloy. 
     
     
         16 . The method of  claim 14  wherein the retainer is comprised of stainless steel, MP35N, platinum, nitinol, cobalt chromium or alloys thereof. 
     
     
         17 . The method of  claim 14  wherein the retainer is comprised of a alloy containing at least a trace of an element having an atomic number greater than 53 to enhance visibility of the retainer under fluoroscopy. 
     
     
         18 . The method of  claim 14  wherein the retainer is comprised of poly lactic acid (PLA) and/or poly glycolic acid (PGA). 
     
     
         19 . The system of  claim 14  wherein the ends of at least one prong may be deformed to prevent the retainer from leaving the plicated tissue.