Device and method for transseptal puncture

Abstract

The present invention provides transseptal puncture devices configured to access structures on the left side of the heart from the right side of the heart without requiring open-heart surgery. The devices have adjustable stiffness to enter the vasculature in a flexible, atraumatic fashion, then become rigid once in place to provide a stable platform for penetration of the fossa ovalis. The devices are further configured to controllably and stably extend a needle to puncture the FO. The devices include an indwelling blunt stylus that can extend perpendicularly from the device to increase the accuracy of placement near the fossa ovalis.

What is claimed is: 
     
         1 . A method, comprising:
 with a deflectable stylus disposed within a right atrium of a heart, extending an atraumatic support (1) having an end effector at its distal end, and (2) that is disposed at least partially within the stylus, distally from a distal end portion of the stylus such that the end effector contacts the septum; and   with the end effector in contact with the septum, extending a puncture member that is slidably disposed within the atraumatic support distally from the end effector such that the puncture member pierces the septum.   
     
     
         2 . The method of  claim 1 , wherein the stylus is coupled to a shaft, the method further comprising:
 inserting the shaft into the heart such that a distal end portion of the stylus is disposed in the right atrium of the heart; and   deflecting the stylus such that the distal end portion of the stylus points towards the septum of the heart.   
     
     
         3 . The method of  claim 1 , wherein the extending the puncture member such that the puncture member pierces the septum includes extending the puncture member into a left atrium of the heart, the method further comprising:
 with the puncture member disposed in the left atrium, extending distally a guide wire from within a lumen defined by the puncture member from the puncture member and into the left atrium.   
     
     
         4 . The method of  claim 3 , further comprising:
 with the guide wire disposed in the left atrium, withdrawing proximally the puncture member from the left atrium and into the atraumatic support such that a distal end of the puncture member is disposed within the atraumatic support.   
     
     
         5 . The method of  claim 2 , wherein the extending the puncture member distally from the atraumatic support includes extending the puncture member distally along a longitudinal axis that is substantially perpendicular to a longitudinal axis of the shaft. 
     
     
         6 . The method of  claim 1 , wherein the extending the atraumatic support distally from the stylus towards and into contact with the septum includes tenting the septum with the end effector. 
     
     
         7 . The method of  claim 1 , wherein the extending the puncture member such that the puncture member pierces the septum includes piercing a fossa ovalis of the heart. 
     
     
         8 . The method of  claim 7 , wherein the extending the atraumatic support distally from the distal end portion of the stylus includes extending the end effector from a lumen defined by the stylus such that the end effector expands in cross-sectional area as it exits the lumen. 
     
     
         9 . The method of  claim 8 , wherein the end effector expands as it exits the lumen from a diameter of between about 5 mm and about 7 mm to a diameter of between about 8 mm and about 15 mm. 
     
     
         10 . The method of  claim 8 , wherein the end effector expands at least about three times its diameter when disposed within the lumen. 
     
     
         11 . The method of  claim 1 , wherein prior to the extending the atraumatic support distally from the distal end portion of the stylus, the end effector of the atraumatic support is disposed within a lumen defined by the stylus. 
     
     
         12 . The method of  claim 1 , further comprising:
 visualizing from outside the patient a radiopaque or echo-bright marker disposed within the heart of the patient.   
     
     
         13 . The method of  claim 2 , further comprising:
 visualizing from outside the patient a radiopaque or echo-bright marker that is disposed at the shaft, the atraumatic support, the end effector, or the stylus, and within the heart of the patient.   
     
     
         14 . The method of  claim 1 , wherein the end effector has a cross-sectional area greater than a cross-sectional area of the distal end portion of the stylus. 
     
     
         15 . The method of  claim 1 , wherein the end effector includes a bell shape. 
     
     
         16 . The method of  claim 1 , wherein the end effector has a flat distal end surface. 
     
     
         17 . The method of  claim 2 , wherein the inserting the shaft includes slidably advancing the shaft about a guidewire. 
     
     
         18 . The method of  claim 2 , wherein the inserting the shaft includes inserting the shaft into an inferior vena cava of the heart and a superior vena cave of the heart. 
     
     
         19 . The method of  claim 2 , wherein the stylus is slidably coupled to the shaft. 
     
     
         20 . The method of  claim 2 , wherein the extending the puncture member distally from the atraumatic support includes extending the puncture member distally along an longitudinal axis that is between about 0 degrees and about 90 degrees relative to a longitudinal axis of the shaft. 
     
     
         21 . An apparatus, comprising:
 a shaft defining a lumen;   a deflectable stylus;   an atraumatic support (1) having an end effector at its distal end, and (2) slidably coupled to the stylus; and   a puncture member slidably disposed within a lumen defined by the atraumatic support and advanceable distally from the end effector, the puncture member configured to puncture tissue of the patient.   
     
     
         22 . The apparatus of  claim 21 , wherein the stylus is angularly deflectable relative to the shaft such that a distal end portion of the stylus points away from a centerline of the shaft. 
     
     
         23 . The apparatus of  claim 21 , wherein the puncture member defines a lumen configured to slidably receive a guide wire. 
     
     
         24 . The apparatus of  claim 21 , wherein the end effector is configured to transition between a delivery configuration in which the end effector has a first cross-sectional area and a deployed configuration in which the end effector has a second cross-sectional area that is greater than the first cross-sectional area. 
     
     
         25 . The apparatus of  claim 21 , wherein the end effector has a cross-sectional area greater than a cross-sectional area of the distal end portion of the stylus. 
     
     
         26 . The apparatus of  claim 21 , wherein the atraumatic support is slidably disposed within a lumen defined by the stylus. 
     
     
         27 . The apparatus of  claim 26 , wherein the end effector has a diameter greater than a diameter of the lumen defined by the stylus, the end effector being disposed distal to the distal end portion of the stylus. 
     
     
         28 . The apparatus of  claim 21 , wherein the end effector includes a bell shape. 
     
     
         29 . The apparatus of  claim 21 , wherein the end effector includes an inflatable balloon. 
     
     
         30 . The apparatus of  claim 21 , wherein the end effector has a flat distal end surface.