Transcatheter device for interatrial anastomosis

Abstract

The present disclosure relates to a device assembly and a method for treating heart failure by normalizing elevated blood pressure in the left atrium of a heart of a mammal. Disclosed herein is a transcatheter interatrial septum excision device assembly configured to create a sized interatrial aperture between the right and left atria of a heart for the relief of elevated left atrial pressure. The device assembly comprises a delivery catheter, a tissue stabilizer attached to a first catheter having a central lumen and a penetrating tip that permits passage of a guidewire, and a cutter attached to a second catheter having a central lumen that permits passage of the first catheter. Alternative configurations comprise a (third) catheter having a central lumen that permits passage of the aforementioned components to and from the right atrium, a tissue retention mechanism and an optional coaxial alignment mechanism.

1 . A method for treating heart failure comprising:
 advancing an expandable tissue stabilizer adjacent a first side of an interatrial septum, wherein the expandable tissue stabilizer has a first collapsed configuration and a second expanded configuration, and comprises a loop supported by a plurality of tines;   advancing an expandable cutter adjacent a second side of the interatrial septum, wherein the expandable cutter has a first collapsed configuration and a second expanded configuration, and comprises a loop supported by a plurality of struts and a radio frequency ablation element;   ablating tissue across the interatrial septum to excise interatrial tissue;   capturing the excised interatrial tissue with the expandable cutter;   collapsing the expandable cutter with the excised interatrial tissue into a delivery sheath; and   removing the delivery sheath.   
     
     
         2 . The method of  claim 1 , wherein advancing the expandable cutter adjacent the second side of the interatrial septum comprises advancing the expandable cutter through the interatrial septum. 
     
     
         3 . The method of  claim 1 , wherein the expandable cutter is housed in a lumen of a cutter sheath in the first collapsed configuration. 
     
     
         4 . The method of  claim 1 , further comprising retracting the delivery sheath to expand the cutter to the expanded configuration. 
     
     
         5 . The method of  claim 1 , wherein capturing the excised interatrial tissue with the expandable cutter comprises collapsing the expandable cutter within the tissue stabilizer. 
     
     
         6 . The method of  claim 5 , further comprising collapsing the tissue stabilizer. 
     
     
         7 . The method of  claim 1 , wherein collapsing the expandable cutter with the excised interatrial tissue into the delivery sheath comprises advancing the delivery sheath over the tissue stabilizer and the cutter. 
     
     
         8 . The method of  claim 7 , wherein the tissue stabilizer and the cutter are collapsed simultaneously. 
     
     
         9 . The method of  claim 1 , wherein the tissue stabilizer is mounted to a distal end of a stabilizer catheter. 
     
     
         10 . The method of  claim 1 , wherein excising interatrial tissue comprises creating an opening of sufficient size to relieve interatrial pressure. 
     
     
         11 . The method of  claim 10 , wherein the opening has a diameter of approximately 5-12 millimeters. 
     
     
         12 . The method of  claim 1 , wherein excising interatrial tissue comprises retracting the cutter proximally through the interatrial septum. 
     
     
         13 . The method of  claim 1 , wherein a circumference of the cutter in the expanded configuration is smaller than a circumference of the tissue stabilizer in the expanded configuration. 
     
     
         14 . The method of  claim 1 , wherein the cutter and the tissue stabilizer are housed within the delivery sheath in the collapsed configurations. 
     
     
         15 . The method of  claim 9 , wherein the tissue stabilizer catheter is slidably engaged within a lumen of the delivery sheath. 
     
     
         16 . The method of  claim 1 , wherein the cutter is slidably engaged within a lumen of the delivery sheath. 
     
     
         17 . The method of  claim 1 , wherein advancing the expandable tissue stabilizer to a first side of the interatrial septum comprises advancing the tissue stabilizer to a location at or near a fossa ovalis.