Minimally invasive repair of heart valve leaflets

Abstract

A method of repairing a heart valve provides intravascular access for repair of a heart valve through a ventricular trans-septal approach. An external guide catheter can be inserted through a vein of a patient into the right ventricle via the right atrium. An internal guide catheter can be inserted through the external guide and can provide access to the septum for a puncture tool to create an opening through the septum to the left ventricle. The internal guide can then be advanced into the left ventricle and used to guide a deployment catheter that deploys a repair device onto the heart valve.

1 . A method of repairing a heart valve in a beating heart of a patient, comprising:
 inserting an external guide catheter through a vein of a patient and into a right atrium of a heart of a patient;   advancing the external guide catheter into a right ventricle of the patient's heart;   inserting an internal guide catheter into the external guide catheter and advancing the internal guide catheter into the right ventricle;   puncturing a septum in the patient's heart to create an opening between the right ventricle and a left ventricle;   advancing the internal guide catheter through the opening in the septum and into the left ventricle;   inserting a deployment catheter through the internal guide catheter and advancing the deployment catheter adjacent a heart valve in the left ventricle; and   deploying a repair device onto the heart valve with the deployment catheter.   
     
     
         2 . The method of  claim 1 , further comprising:
 advancing a sealing device through the internal guide catheter to the septum; and   positioning the sealing device within the opening in the septum to seal the opening.   
     
     
         3 . The method of  claim 1 , wherein the repair device is a suture. 
     
     
         4 . The method of  claim 3 , wherein deploying a repair device onto the heart valve with the deployment catheter includes:
 capturing a heart valve leaflet with a clamping mechanism of the deployment catheter; and   inserting the suture through the heart valve leaflet with a needle of the deployment catheter.   
     
     
         5 . The method of  claim 3 , further comprising:
 advancing a sealing device through the internal guide catheter to the septum;   extending the suture through a lumen extending through the sealing device; and   positioning the sealing device within the opening in the septum to seal the opening, such that a proximal end of the suture extends from the heart valve through the septum.   
     
     
         6 . The method of  claim 5 , further comprising:
 threading the suture through an anchoring device;   advancing the anchoring device through the internal guide catheter to the septum;   interfacing the anchoring device with the sealing device to lock a position of the suture with respect to the sealing device;   advancing a cutting catheter having a cutting tool through the internal guide catheter to the septum; and   cutting the suture in the right ventricle adjacent the sealing device.   
     
     
         7 . The method of  claim 5 , further comprising selectively tensioning the suture to have a desired tension through the septum. 
     
     
         8 . The method of  claim 7 , wherein the suture tension is maintained by a seal within the sealing element that engages the suture, and further comprising:
 releasing the tension on the suture by engaging the seal to cause the seal to release the suture; and   retensioning the suture.   
     
     
         9 . The method of  claim 3 , wherein the deployment catheter deploys a plurality of sutures on the valve. 
     
     
         10 . A method comprising:
 providing a heart valve repair system, the system including an external guide catheter, an internal guide catheter adapted to be slidably inserted through the external guide catheter, a septal puncture tool and a deployment catheter; and   providing instructions for deploying a repair device onto a heart valve of a beating heart of a patient with the heart valve repair system, the instructions comprising:
 inserting the external guide catheter through a vein of the patient and into a right atrium of a heart of the patient; 
 advancing the external guide catheter into a right ventricle of the patient's heart; 
 inserting the internal guide catheter into the external guide catheter and advancing the internal guide catheter into the right ventricle; 
 inserting the septal puncture tool through the internal guide catheter and puncturing a septum of the patient with the septal puncture tool to create an opening through the septum between the right ventricle and a left ventricle; 
 advancing the internal guide catheter through the opening in the system and into the left ventricle; 
 inserting the deployment catheter through the internal guide catheter and advancing the deployment catheter adjacent the heart valve; and 
 deploying a repair device onto the heart valve with the deployment catheter. 
   
     
     
         11 . The method of  claim 10 , wherein providing a heart valve repair system includes providing a sealing device, and the instructions further comprise:
 advancing the sealing device through the internal guide catheter to the septum; and   positioning the sealing device within the opening in the septum to seal the opening.   
     
     
         12 . The method of  claim 10 , wherein providing a heart valve repair system includes providing a suture as the repair device, wherein deploying a repair device onto the heart valve with the deployment catheter includes:
 capturing a heart valve leaflet with a clamping mechanism of the deployment catheter; and   inserting the suture through the heart valve leaflet with a needle of the deployment catheter.   
     
     
         13 . The method of  claim 10 , wherein providing a heart valve repair system includes providing a sealing device and providing a suture as the repair device and wherein the instructions further comprise:
 advancing the sealing device through the internal guide catheter to the septum;   extending the suture through a lumen extending through the sealing device; and   positioning the sealing device within the opening in the septum to seal the opening, such that a proximal end of the suture extends from the heart valve through the septum.   
     
     
         14 . The method of  claim 13 , wherein providing a heart valve repair system includes providing an anchoring device and a cutting catheter having a cutting tool, and the instructions further comprise:
 threading the suture through the anchoring device;   advancing the anchoring device through the internal guide catheter to the septum;   interfacing the anchoring device with the sealing device to lock a position of the suture with respect to the sealing device;   advancing the cutting catheter through the internal guide catheter to the septum; and   cutting the suture in the right ventricle adjacent the sealing device with the cutting tool.   
     
     
         15 . The method of  claim 14 , wherein the instructions further comprise selectively tensioning the suture to have a desired tension through the septum. 
     
     
         16 . A system comprising:
 means for intravenously accessing a right ventricle of a beating heart of a patient;   means for creating an opening through a septum of the patient's heart between the right ventricle and a left ventricle;   means for deploying a repair device onto a heart valve;   means for positioning the means for deploying in the left ventricle; and   means for sealing the opening in the septum.   
     
     
         17 . The system of  claim 16 , wherein the means for deploying a repair device includes a means for grasping a heart valve leaflet and a means for inserting a suture through the leaflet. 
     
     
         18 . The system of  claim 17 , further comprising means for selectively tensioning the suture through the sealing device. 
     
     
         19 . The system of  claim 17 , further comprising means for anchoring the suture at the sealing device. 
     
     
         20 . The system of  claim 18 , further comprising means for selectively retensioning the suture.