Balloon visualization for traversing a tissue wall

Abstract

Systems and methods for controllably traversing a tissue wall. In one embodiment, a distal end of a catheter is positioned and/or repositioned utilizing direct visualization out the distal end of the catheter, as facilitated by an imaging element disposed within the distal tip of the catheter. An inflatable balloon may comprise a portion of the distal tip of the catheter for structural and/or visualization media purposes. A tissue traversing element may be forwarded through a working lumen defined by the catheter and controllably pushed through a tissue wall as observed with the imaging element. The tissue traversing element may comprise sensors and the like to facilitate monitoring of changes in pressure, color, oxygen saturation, flow rate, and echo timing, to determine the position of the tissue traversing member relative to the tissue wall.

1 . (canceled) 
     
     
         2 . A method for traversing a tissue wall in a body, comprising:
 endoluminally advancing a direct visualization elongate instrument into a first cavity opposite a tissue wall from a second cavity, wherein the elongate instrument comprises at its distal end an imaging element and a component configured to provide a substantially unobstructed field of view;   approaching the tissue wall with the elongate instrument;   adjusting the relative positioning between the distal end of the elongate instrument and the tissue wall based upon direct visualization feedback;   engaging the tissue wall with the component, and providing a path to the tissue wall with the lumen of the elongate instrument extending through the component;   controllably advancing a tissue traversing member out of the lumen of the elongate instrument, through the component, and through the tissue wall into the second cavity; and   upon traversing the tissue wall, confirming a position of the traversing member in the second cavity using an imaging element or sensing element positioned in the second cavity;   
     
     
         3 . The method of  claim 2 , wherein approaching the tissue wall comprises
 advancing the elongate instrument distal end to a position adjacent the tissue wall with the elongate instrument distal end in a contracted shape, and   expanding the component into an expanded shape such that a distal face of the component is substantially normal to the longitudinal axis of the elongate instrument to facilitate a larger direct visualization field of view of the tissue wall.   
     
     
         4 . The method of  claim 2 , wherein adjusting the relative positioning comprises capturing images with an imaging element positioned within an interior of the elongate instrument distal end, the images representing one or both of structures located immediately adjacent an exterior of the elongate instrument distal end within a field of view of the imaging element, and structures comprising the elongate instrument distal end within the field of view of the imaging element. 
     
     
         5 . The method of  claim 2 , wherein engaging the tissue wall comprises advancing the elongate instrument toward the tissue wall until contact is observed in the direct visualization feedback. 
     
     
         6 . The method of  claim 5 , wherein engaging the tissue wall further comprises ejecting saline between the elongate instrument distal end and the tissue wall to displace blood or other fluids in order to enhance visualization of the tissue wall. 
     
     
         7 . The method of  claim 2 , wherein controllably advancing the tissue traversing member comprises observing a relative positioning of the tissue wall, the tissue traversing member, and the elongate instrument distal end with direct visualization feedback. 
     
     
         8 . The method of  claim 2 , wherein controllably advancing the tissue traversing member comprises monitoring a variable selected from a group consisting of pressure, color, oxygen saturation, flow rate, and echo timing, in order to determine the position of the tissue traversing member relative to the tissue wall. 
     
     
         9 . The method of  claim 2 , wherein the tissue wall is an atrial septum and approached from a right atrium, and wherein the tissue traversing member is controllably advanced through the atrial septum into a left atrium. 
     
     
         10 . The method of  claim 9 , wherein adjusting the relative positioning comprises locating the position of a fossa ovalis upon the atrial septum. 
     
     
         11 . The method of  claim 2 , where the traversing member further includes a piercing tip and a traversing lumen, where the traversing lumen provide access across the tissue wall after withdrawing the elongate instrument away from the tissue wall. 
     
     
         12 . The method of  claim 11 , further comprising advancing tools through the traversing lumen. 
     
     
         13 . The method of  claim 2 , wherein endoluminally advancing a direct visualization elongate instrument comprises intravascularly advancing a direct visualization elongate instrument. 
     
     
         14 . The method of  claim 2 , wherein the component is a balloon. 
     
     
         15 . A system to controllably traverse a tissue wall in a body, comprising:
 an elongate tubular member having a distal end and defining a working lumen;   a component configured to provide a substantially unobstructed field, of view coupled to the distal end of the elongate tubular member, the component having a distal face and a proximal end, where, when expanded the distal face is substantially normal to the longitudinal axis of the working lumen;   a first imaging element disposed in an interior of the component or at a distal end of the elongate tubular member or the component;   a lighting element disposed in the interior of the component or at a distal end of the elongate tubular member or the component;   a tubular element defining a lumen between the distal end of the component and a distal end of the working lumen of the elongate tubular member;   a tissue traversing element configured to advance from a first cavity through and across a tissue wall into a second cavity, wherein the tissue traversing element is disposed within the working lumen of the elongate tubular member and positioned to slidably extend through the working lumen and tubular element lumen and beyond the component distal face within a field of view of the first imaging element;   and a sensing element or second imaging element coupled to the tissue traversing member or to a sleeve surrounding the tissue traversing member and configured for detection in the second cavity to confirm a position of the traversing member or the sleeve in the second cavity.   
     
     
         16 . The system of  claim 15 , wherein the elongate tubular member further defines at least one component sizing lumen to supply fluid to expand the component. 
     
     
         17 . The system of  claim 15 , wherein the elongate tubular member further defines a lumen for transmitting light energy and image data between one or more external devices and the respective lighting and imaging elements. 
     
     
         18 . The system of  claim 15 , wherein the first imaging element comprises a charge-coupled device. 
     
     
         19 . The system of  claim 15 , wherein the first imaging element comprises an optical fiber. 
     
     
         20 . The system of  claim 15 , wherein the lighting element comprises a structure selected from the group consisting of an incandescent light source, a light-emitting diode, and an optical fiber. 
     
     
         21 . The system of  claim 15 , wherein the tissue traversing member carries the sensing element which is configured to monitor a variable selected from a group consisting of pressure, color, oxygen saturation, flow rate, and echo timing. 
     
     
         22 . The system of  claim 15 , wherein the first imaging element is disposed adjacent the component proximal end. 
     
     
         23 . The system of  claim 15 , wherein the first imaging element is disposed adjacent the component distal end. 
     
     
         24 . The system of  claim 23 , wherein a field of view of the first imaging element does not include portions of the component. 
     
     
         25 . The system of  claim 15  wherein the distal end of the component forms a concave surface out of which a field of view of the first imaging element extends distally. 
     
     
         26 . The system of  claim 15 , wherein the component is a balloon.