Imaging apparatus and systems and methods for using them

Abstract

Systems and methods are provided for injecting one or more agents into tissue within a patient's body that includes a catheter. A needle guide extends from a distal end of the catheter and terminates at a distal tip, e.g., including a foot with an atraumatic contact surface, the needle guide having a cross-section smaller than the distal end and being biased to a curved shape. The needle guide includes a passage communicating from a lumen of the catheter to an outlet at the distal tip, and a needle device is disposed within the passage that may be deployed from the outlet to inject one or more agents into tissue. The catheter also includes an imaging assembly on the distal end configured to acquire images of tissue adjacent the needle guide distal tip.

1 . An apparatus for imaging tissue during a medical procedure, comprising:
 a tubular member comprising a proximal end, a distal end sized for introduction into a patient's body, a longitudinal axis extending between the proximal and distal ends, and a primary lumen extending from the proximal end to an opening adjacent the distal end;   a stabilization member extending distally beyond the distal end to a distal tip, the tubular extension having a cross-section smaller than the distal end;   a substantially transparent expandable member comprising a first end attached to the tubular member distal end and a second end attached adjacent the distal tip; and   an imaging assembly carried on the stabilization member and oriented to acquire images transversely relative to the longitudinal axis such that a device deployed from the opening is within a field of view of the imaging assembly.   
     
     
         2 . The apparatus of  claim 1 , wherein the stabilization member comprises first and second elongate members disposed adjacent one another and comprising first ends coupled to the tubular member distal end and second ends coupled together at the distal tip. 
     
     
         3 . The apparatus of  claim 2 , wherein the first and second elongate members are disposed adjacent one another generally within a plane and wherein the imaging assembly is mounted to the first and second members such that the field of view of the imaging assembly is transverse relative to the plane. 
     
     
         4 . The apparatus of  claim 3 , wherein the opening of the primary lumen is disposed in a side wall of the tubular member distal end such that the opening does not intersect the plane. 
     
     
         5 . The apparatus of  claim 1 , wherein the opening is at a location on the tubular member distal end that is proximal to the first end of the expandable member. 
     
     
         6 . The apparatus of  claim 1 , wherein the opening is configured such that a device deployed from the opening extends substantially parallel to the longitudinal axis. 
     
     
         7 . The apparatus of  claim 1 , wherein the opening is configured such that a device deployed from the opening extends transversely relative to the longitudinal axis. 
     
     
         8 . The apparatus of  claim 7 , wherein the tubular member distal end includes a ramped surface within the primary lumen adjacent the opening for deploying a device from the opening at an acute angle relative to the longitudinal axis. 
     
     
         9 . The apparatus of  claim 7 , wherein the opening is disposed in a side wall of the tubular member distal end. 
     
     
         10 . The apparatus of  claim 9 , wherein opening is located at a first circumferential location on the side wall and wherein a proximal end of the stabilization member is coupled to the tubular member distal end at a location closer a second circumferential location on the side wall opposite the first circumferential location. 
     
     
         11 . The apparatus of  claim 1 , wherein the expandable member comprises a compliant balloon. 
     
     
         12 . The apparatus of  claim 1 , wherein the expandable member comprises one or more compliant balloons defining a channel adjacent the outlet such that a device deployed from the opening extends along the channel outside the balloon. 
     
     
         13 . The apparatus of  claim 1 , wherein the stabilization member is biased to a curvilinear shape and is flexibly movable to a substantially straightened shape to facilitate introduction into a patient's body. 
     
     
         14 . The apparatus of  claim 1 , wherein the expandable member is expandable from a contracted condition to an enlarged condition when fluid is introduced through an inflation lumen of the tubular member into an interior of the expandable member. 
     
     
         15 . The apparatus of  claim 1 , wherein the stabilization member comprises an elongate wire including a first end coupled to the tubular member distal end and a second end adjacent the distal tip. 
     
     
         16 . The apparatus of  claim 1 , wherein the stabilization member comprises an elongate wire loop including first and second ends coupled to the tubular member distal end and an intermediate region adjacent the distal tip. 
     
     
         17 - 18 . (canceled) 
     
     
         19 . The apparatus of  claim 1 , wherein the stabilization member comprises an elongate member coupled to a wall of the expandable member and including a first end coupled to the tubular member distal end and a second end adjacent the distal tip, wherein the imaging assembly is carried at an intermediate location between the first and second ends such that the imaging assembly moves away from the longitudinal axis when the expandable member is expanded from a contracted condition to an enlarged condition. 
     
     
         20 . The apparatus of  claim 1 , wherein the stabilization member extends through an interior of the expandable member and wherein the imaging assembly is carried on the stabilization member within the interior. 
     
     
         21 . A system for imaging tissue during a medical procedure, comprising:
 a tubular member comprising a proximal portion, a distal portion sized for introduction into a patient's body, a longitudinal axis extending between the proximal and distal portions, and a primary lumen extending from the proximal portion to an opening on the distal portion;   a stabilization member extending distally beyond the distal portion to a distal tip;   a substantially transparent expandable member comprising a first end attached to the distal portion and a second end attached adjacent the distal tip;   an imaging assembly carried on the distal portion and oriented to acquire images transversely relative to the longitudinal axis; and   a secondary device comprising a distal end sized for introduction through the primary lumen and outlet adjacent the expandable member such the device is within a field of view of the imaging assembly.   
     
     
         22 - 40 . (canceled) 
     
     
         41 . A method for imaging tissue structures within a patient's body, comprising:
 introducing a distal end of a tubular member into a body lumen;   expanding an expandable member on the distal end within the body lumen;   acquiring one or more images of an area adjacent a side wall of the expandable member using an imaging assembly on the tubular member distal end to identify a target location;   deploying a device from an opening in the tubular member distal end adjacent the side wall of the expandable member; and   positioning the device adjacent the target location while imaging using the imaging assembly.   
     
     
         42 - 49 . (canceled)