Mitral valve repair system and method for use

Abstract

The present invention is directed to various systems for repairing tissue within the heart of a patient. The mitral valve repair system of the present invention comprises a guide catheter having a proximal end, a distal end, and at least one internal lumen formed therein, a therapy catheter capable of applying a suture to the tissue, and a fastener catheter capable of attaching a fastener to the suture. The therapy catheter and the fastener catheter are capable of traversing the internal lumen of the guide catheter. In addition, the present invention discloses various methods for repairing tissue within the heart of a patient. In one embodiment, the method of repairing heart valve tissue includes advancing a guide catheter through a circulatory pathway to a location in the heart proximate to a heart valve, advancing a therapy catheter through the guide catheter to the heart valve, stabilizing a first leaflet with the therapy catheter, deploying a first suture into the stabilized first leaflet, disengaging the first leaflet from the therapy catheter while leaving the first suture attached thereto, stabilizing a second leaflet with the therapy catheter, deploying a second suture into the second leaflet, disengaging the second leaflet from the therapy catheter while leaving the second suture attached thereto, and joining the first and second leaflets by reducing the distance between the first and second sutures.

1 . A method of repairing tissue within the heart of a patient, comprising;
 advancing a guide catheter through a circulatory pathway to a location in the heart proximate to a heart valve;   advancing a therapy catheter through the guide catheter to the heart valve;   stabilizing a first leaflet with the therapy catheter;   deploying a first suture material into the stabilized first leaflet;   disengaging the first leaflet from the therapy catheter while leaving the first suture material attached thereto;   stabilizing a second leaflet with the therapy catheter;   deploying a second suture material into the second leaflet;   disengaging the second leaflet from the therapy catheter while leaving the second suture material attached thereto;   removing the therapy catheter from the guide catheter;   advancing a fastener catheter along the first and second suture material through the guide catheter to the heart valve; and   joining the first and second leaflets by reducing a distance between the first and second sutures with a fastener deployed from the fastener catheter.   
   
   
       2 . The method of  claim 1 , further comprising:
 cutting the first and second suture portions.   
   
   
       3 . The method of  claim 2 , wherein the fastener catheter comprises a suture cutter, and cutting the first and second suture portions is performed by the fastener catheter suture cutter, and wherein the method further comprises:
 removing the fastener catheter from the patient.   
   
   
       4 . The method of  claim 1 , wherein the therapy catheter comprises a suction recess on a first side of the therapy catheter, and the method further comprises:
 rotating the therapy catheter, wherein rotating the therapy catheter occurs after disengaging the first leaflet from the therapy catheter, and prior to stabilizing the second leaflet with the therapy catheter.   
   
   
       5 . The method of  claim 1 , wherein the fastener comprises a memory material and is configured to receive the first and second suture portions and to secure the first and second suture portions when released from the fastener, and the method further comprises:
 releasing the fastener from the fastener catheter, whereby the fastener is secured to the first and second suture portions.   
   
   
       6 . The method of  claim 1 , wherein the fastener comprises one or more engagement members configured to engage and secure the first and second suture portions. 
   
   
       7 . A method of repairing tissue within the heart of a patient, comprising;
 advancing a guide catheter through a circulatory pathway to a location in the heart;   advancing a therapy catheter through the guide catheter into the heart and adjacent a first heart tissue portion;   stabilizing the first heart tissue portion with the therapy catheter;   deploying a first suture material into the stabilized first heart tissue portion;   disengaging the first heart tissue portion from the therapy catheter while leaving the first suture material attached thereto;   stabilizing a second heart tissue portion with the therapy catheter;   deploying a second suture material into the second heart tissue portion;   disengaging the second heart tissue portion from the therapy catheter while leaving the second suture material attached thereto;   removing the therapy catheter from the guide catheter;   advancing a fastener catheter along the first and second suture material through the guide catheter and into the heart; and   joining the first and second sutures with a fastener deployed from the fastener catheter.   
   
   
       8 . The method of  claim 7 , wherein further comprising:
 pulling the first suture portion and the second suture portion while advancing the fastener catheter along the first and second suture material.   
   
   
       9 . The method of  claim 8 , wherein the fastener catheter is advanced along the first and second suture material until the fastener catheter is adjacent the first heart tissue portion and the second heart tissue portion, thereby decreasing the distance between the first heart tissue portion and the second heart tissue portion. 
   
   
       10 . The method of  claim 7 , wherein advancing the fastener catheter comprises advancing the fastener catheter to a position adjacent the first heart tissue portion. 
   
   
       11 . The method of  claim 7 , wherein advancing the fastener catheter comprises advancing the fastener catheter to a position adjacent the second heart tissue portion. 
   
   
       12 . The method of  claim 7 , wherein the fastener catheter comprises a suture cutter, and the method further comprises:
 cutting the first and second suture portions; and   removing the fastener catheter from the patient.   
   
   
       13 . The method of  claim 7 , further comprising:
 repositioning the therapy catheter, wherein repositioning the therapy catheter adjacent the second heart tissue portion occurs after disengaging the first heart tissue portion from the therapy catheter, and prior to stabilizing the second heart tissue portion with the therapy catheter.   
   
   
       14 . The method of  claim 13 , wherein repositioning the therapy catheter comprises rotating the therapy catheter. 
   
   
       15 . The method of  claim 7 , wherein the first heart tissue portion and the second heart tissue portion are at or adjacent a patent foramen ovale. 
   
   
       16 . The method of  claim 7 , wherein the first heart tissue portion comprises a first valve leaflet. 
   
   
       17 . The method of  claim 7 , wherein the second heart tissue portion comprises a second valve leaflet. 
   
   
       18 . A method of repairing tissue within the heart of a patient, comprising;
 advancing a guide catheter through a circulatory pathway to a location in the heart proximate to a heart valve;   advancing a therapy catheter through the guide catheter to the heart valve; inflating an inflatable positioning balloon on the therapy catheter;   engaging a second leaflet with the inflatable positioning balloon thereby directing the therapy catheter to a first leaflet;   stabilizing the first leaflet with the therapy catheter;   deploying a first suture material into the stabilized first leaflet;   disengaging the first leaflet from the therapy catheter while leaving the first suture material attached thereto;   engaging the first leaflet with the inflatable positioning balloon thereby directing the therapy catheter to the second leaflet;   stabilizing a second leaflet with the therapy catheter;   deploying a second suture material into the second leaflet;   disengaging the second leaflet from the therapy catheter while leaving the second suture material attached thereto;   deflating the inflatable positioning balloon;   removing the therapy catheter from the guide catheter;   advancing a fastener catheter along the first and second suture material through the guide catheter to the heart valve; and   joining the first and second leaflets by reducing a distance between the first and second sutures with a fastener deployed from the fastener catheter.   
   
   
       19 . The method of  claim 18 , further comprising:
 cutting the first and second suture portions.   
   
   
       20 . The method of  claim 19 , wherein the fastener catheter comprises a suture cutter, and cutting the first and second suture portions is performed by the fastener catheter suture cutter, and wherein the method further comprises:
 removing the fastener catheter from the patient.