Guarded imaging devices and methods

Abstract

An integrated therapeutic and imaging device that uses at least two balloons to provide a guarded zone that can be evacuated and replaced with a fluid that is sufficiently clear to permit optical coherence tomography (or even high resolution ultrasound) imaging that would otherwise be of poor quality or impossible. Methods of making and operating the imaging device to obtain clear, high quality images, as well as treating a patient's tissue with the device within a living body in association with obtaining an image of the patient's tissue, are included.

1 . (canceled) 
     
     
         2 . A catheter, comprising:
 a flexible elongate body configured to be positioned within a patient, the flexible elongate body comprising a proximal portion, a distal portion, and an outer profile;   a first balloon coupled to the distal portion;   a second balloon coupled to the distal portion, wherein the second balloon is spaced from the first balloon along a length of the flexible elongate body;   an operative element coupled to the distal portion and positioned along the length of the flexible elongate body between the first balloon and the second balloon;   wherein the flexible elongate body further comprises:
 a guarded zone positioned between the first balloon and the second balloon, wherein the operative element is aligned with the guarded zone along the length of the flexible elongate body to image, treat, and/or diagnose a tissue zone adjacent to the guarded zone; 
 an operative lumen extending within the outer profile from the proximal portion to the operative element and configured to facilitate imaging, treatment, and/or diagnosis of the tissue zone by the operative element; and 
 a guidewire lumen extending within the outer profile and adjacent to the operative lumen along at least a portion of the length of the flexible elongate body. 
   
     
     
         3 . The catheter of  claim 2 , wherein the guidewire lumen extends to a position distal of the first balloon and the second balloon. 
     
     
         4 . The catheter of  claim 2 , wherein the operative element is an imaging component. 
     
     
         5 . The catheter of  claim 4 , wherein the flexible elongate body further comprises an electrical conductor disposed within the operative lumen, and wherein the operative element comprises an ultrasound transducer in communication with the electrical conductor. 
     
     
         6 . The catheter of  claim 4 , wherein the flexible elongate body further comprises an optical fiber disposed within the operative lumen, wherein the operative element comprises an optical coherence tomography (OCT) device in communication with the optical fiber. 
     
     
         7 . The catheter of  claim 2 , wherein the operative element is a therapeutic component. 
     
     
         8 . The catheter of  claim 7 , wherein the flexible elongate body further comprises an electrical conductor disposed within the operative lumen, wherein the operative element comprises an ablation device in communication with the electrical conductor. 
     
     
         9 . The catheter of  claim 7 , wherein the operative element comprises an opening of the flexible elongate body in communication with the operative lumen, wherein the operative lumen is configured to deliver a therapeutic agent into the patient via the opening. 
     
     
         10 . The catheter of  claim 2 , wherein the operative element comprises an opening of the flexible elongate body in communication with the operative lumen, wherein the operative lumen is configured to transfer fluid into or out of the tissue zone. 
     
     
         11 . The catheter of  claim 10 , wherein the flexible elongate body further comprises a further lumen configured to transfer fluid into the tissue zone, and wherein the operative lumen is configured to transfer fluid out of the tissue zone. 
     
     
         12 . The catheter of  claim 2 , wherein the first balloon and second balloon are inflatable independently of each other. 
     
     
         13 . The catheter of  claim 12 , wherein the flexible elongate body further comprises:
 a first connection lumen that extends from the proximal portion to the first balloon to permit transfer of fluid therebetween so as to inflate or deflate the first balloon; and   a second connection lumen that extends from the proximal portion into the second balloon to permit transfer of fluid therebetween so as to inflate or deflate the second balloon.