Telescoping catheter delivery system for left heart endocardial device placement

Abstract

A transseptal catheter delivery system includes an elongate first tubular member and an elongate second tubular member receivable within the first tubular member. The first tubular member includes an adjustable portion adjacent a distal end. The second tubular member is adapted to receive an instrument to be placed in the left ventricle, and includes a curved portion adjacent its distal end in a relaxed state. The adjustable portion is deflectable toward the atrial septum to guide a puncturing tool and/or guide insertion of the second tubular member through a septal puncture into the left atrium. Within the left atrium, the curved portion is oriented toward the left ventricle to guide insertion of a guide wire, and subsequently the second tubular member, into the left ventricle. Methods of transvenously accessing a left ventricle are also provided.

1 . A transseptal delivery system for a heart, comprising:
 an elongate first tubular member defining a first lumen extending between a proximal end and a distal end of the first tubular member, the first tubular member having an adjustable portion adjacent its distal end; and   an elongate second tubular member receivable within the first tubular member, the second tubular member defining a lumen extending between a proximal end and a distal end of the second tubular member, the lumen adapted to receive a puncturing tool and an instrument to be placed in the heart, the second tubular member having a curved portion adjacent its distal end in a relaxed state;   wherein, with the first tubular member extending through a superior entry point into a right atrium of the heart, the adjustable portion of the first tubular member is deflectable toward an atrial septum of the heart thereby providing an outlet at its distal end to i) guide the puncturing tool toward the atrial septum for creating a septal puncture, and ii) guide insertion of the second tubular member through the septal puncture into a left atrium of the heart;   wherein, with the first tubular member remaining in the right atrium and with the second tubular member extending through the septal puncture into the left atrium, the curved portion of the second tubular member is oriented toward a left ventricle of the heart thereby providing an outlet at its distal end to guide insertion of a guide extending through the first and the second tubular members into the left ventricle;   wherein, with the first tubular member remaining in the right atrium, the outlet of the first tubular member supports advancement of the second tubular member along the guide into the left ventricle; and   wherein, with the first tubular member remaining in the right atrium and the second tubular member extending into the left ventricle, the lumen of the second tubular member provides a passage for advancing the instrument into the left ventricle.   
     
     
         2 . The delivery system of  claim 1 , wherein the second tubular member is rotatable within the first tubular member through an angular range of motion. 
     
     
         3 . The delivery system of  claim 2 , wherein the angular range of motion is at least about 360 degrees. 
     
     
         4 . The delivery system of  claim 1 , further comprising a dilator receivable within the second tubular member for facilitating advancement of the second tubular member through the septal puncture. 
     
     
         5 . The delivery system of  claim 1 , further comprising the puncturing tool receivable within the second tubular member for creating the septal puncture. 
     
     
         6 . The delivery system of  claim 5 , wherein the puncturing tool is an RF puncture tool or a mechanical puncture tool. 
     
     
         7 . The delivery system of  claim 1 , wherein the instrument is an electrical lead. 
     
     
         8 . The delivery system of  claim 1 , wherein in a deflected state the first tubular member includes an elongated generally straight portion connected to the adjustable portion, the adjustable portion in the deflected state comprising a curved portion having a first curved segment connected to the generally straight portion, a second curved segment connected to the first curved segment and a third curved segment connected to the second curved segment, each curved segment having a different radius of curvature. 
     
     
         9 . The delivery system of  claim 8 , wherein the first curved segment has a radius of curvature between about 3 and about 4 times greater than the radii of curvature of the second and the third curved segments. 
     
     
         10 . The delivery system of  claim 8 , wherein the third curved segment has a subtended angle between about 3 and about 7 times greater than subtended angles of the first and the second curved segments. 
     
     
         11 . The delivery system of  claim 8 , wherein the first and the second curved segments have subtended angles between about 10 degrees and about 20 degrees and the third curved segment has a subtended angle between about 60 degrees and about 90 degrees. 
     
     
         12 . The delivery system of  claim 8 , wherein the first curved segment has a subtended angle of between about 12 degrees and about 13 degrees, the second curved segment has a subtended angle of between about 14 degrees and 16 degrees, and the third curved segment has a subtended angle between about 70 degrees and about 80 degrees. 
     
     
         13 . The delivery system of  claim 1 , wherein the adjustable portion of the first tubular member has a deflection angle of at least about 135 degrees with respect to a line extending from the generally straight portion. 
     
     
         14 . The delivery system of  claim 1 , wherein the adjustable portion of the first tubular member is adjustable through a two-dimensional range of deflection. 
     
     
         15 . The delivery system of  claim 1 , wherein the adjustable portion of the first tubular member is adjustable through a three-dimensional range of deflection. 
     
     
         16 . The delivery system of  claim 1 , wherein the adjustable portion comprises a curved portion in a relaxed state. 
     
     
         17 . The delivery system of  claim 16 , wherein the curved portion comprises an out-of-plane configuration. 
     
     
         18 . The delivery system of  claim 1 , wherein in a relaxed state the curved portion of the second tubular member has a first curved segment connected to a generally straight portion of the tubular member, a second curved segment connected to the first curved segment and a third curved segment connected to the second curved segment, each curved segment having a different radius of curvature, wherein the radius of curvature of the first curved segment is between about 7 inches and about 9 inches, the radius of curvature of the second curved segment is between about 2 inches and about 3 inches, and the radius of curvature of the third curved segment is between about 1 inch and about 2 inches. 
     
     
         19 . A transseptal lead delivery system for a heart, comprising:
 an elongate first tubular member defining a first lumen extending between a proximal end and a distal end of the first tubular member, the first tubular member having an adjustable portion adjacent its distal end; and   an elongate second tubular member receivable within the first tubular member, the second tubular member defining a lumen extending between a proximal end and a distal end of the second tubular member, the lumen adapted to receive a lead, the second tubular member having a curved portion adjacent its distal end;   wherein, with the first tubular member extending into a right atrium of the heart, the adjustable portion of the first tubular member is deflectable toward an atrial septum of the heart thereby providing an outlet at its distal end to guide insertion of the second tubular member through a septal puncture into a left atrium of the heart;   wherein, with the first tubular member remaining in the right atrium and the second tubular member extending through the septal puncture into the left atrium, the curved portion of the second tubular member is directed toward a left ventricle of the heart thereby providing an outlet at its distal end to guide insertion of a guide extending through the first and the second tubular members into the left ventricle;   wherein, with the first tubular member remaining in the right atrium, the outlet of the first tubular member supports advancement of the second tubular member along the guide into the left ventricle; and   wherein, with the first tubular member remaining in the right atrium and the second tubular member extending into the left ventricle, the second tubular member is rotatable within the first tubular member and the lumen of the second tubular member provides a rotatable passage for placement of the lead at a plurality of sites on an endocardial wall of the left ventricle.   
     
     
         20 . The delivery system of  claim 19 , wherein the lumen of the second tubular member is further adapted to receive a puncturing tool and wherein, with the adjustable portion of the first tubular member deflected toward the atrial septum, the outlet at the distal end of the first tubular member guides the puncturing tool toward the atrial septum for creating the septal puncture. 
     
     
         21 . The delivery system of  claim 19 , the second tubular member is rotatable through an angular range of motion with respect to the first tubular member of at least about 360 degrees. 
     
     
         22 - 25 . (canceled)