System and method for precisely identifying a configuration of an anatomical space in real time

Abstract

A method of identifying a configuration of an anatomical space within a patient in real-time for the precise performance of a procedure at a site of medical interest associated with the anatomical space, wherein a catheter containing an external, inflatable imaging bladder is introduced into the patient until the image bladder is generally aligned with the site of medical interest, an imaging probe of an imaging device is operatively positioned relative to the site of medical interest and is activated so as to obtain a real-time image of the site of medical interest, the imaging bladder being filled when needed to essentially turn on and define a visible and discernable interface between the interior of the imaging bladder and a boundary of the anatomical space. Preferably, the method is employed utilizing an identification system that includes a catheter having an imaging bladder disposed in spaced relation from the tip of the catheter and structured to be filled with a fluid such as air through an inflation conduit so that the imaging bladder contacts the patient and defines a visible interface at a boundary therebetween that is visible utilizing an imaging device.

1 . A method of identifying a configuration of an anatomical space within a patient in real time to facilitate precision performance of a procedure at a site of medical interest associated with the anatomical space, said method comprising: 
 a) introducing a catheter containing an external imaging bladder into the anatomical space of the patient until said image bladder is generally aligned with the site of medical interest;    b) operatively positioning an imaging probe of an imaging device relative to the site of medical interest and proximate portions of the anatomical space;    c) activating said imaging device so as to obtain a real time image of the site of medical interest;    d) filling said imaging bladder on demand until said imaging bladder defines an acoustic interface between the interior of said imaging bladder and the anatomical space; and    e) identifying and viewing a boundary of the anatomical space at said acoustic interface during performance of said procedure so as to identify proper positioning relative to the anatomical space.    
     
     
         2 . The method of  claim 1  further comprising: 
 a) introducing said catheter containing a tip bladder and said external, inflatable imaging bladder positioned a determined spacing therefrom into the anatomical space of the patient until said tip bladder enters a known anatomical chamber of the patient;    b) inflating said tip bladder so as to prevent removal thereof from the patient's known anatomical chamber; and    c) withdrawing said catheter from the patient's anatomical space until said tip bladder engages the patient's known anatomical chamber in proximity to an entrance to the anatomical site so as to position said image bladder in generally aligned relation with the site of medical interest.    
     
     
         3 . The method of  claim 1  further comprising inflating said imaging bladder with a fluid.  
     
     
         4 . The method of  claim 3  further comprising inflating said imaging bladder with air as said fluid.  
     
     
         5 . The method of  claim 1  further comprising at least partially filling said imaging bladder with a radio-opaque material.  
     
     
         6 . The method of  claim 1  further comprising inflating said imaging bladder until said imaging bladder begins to contact and minimally expand the anatomical space.  
     
     
         7 . The method of  claim 1  further comprising introducing said catheter having said imaging bladder formed of a substantially thin walled construction.  
     
     
         8 . The method of  claim 1  further comprising introducing said catheter having said imaging bladder with a wall thickness of approximately 0.0001 inches to 0.5 inches.  
     
     
         9 . The method of  claim 1  further comprising introducing said catheter having said imaging bladder with a wall thickness of approximately 0.001 inches to 0.5 inches.  
     
     
         10 . The method of  claim 1  further comprising introducing said catheter having said imaging bladder with a filled diameter of approximately 1 Fr-50 Fr.  
     
     
         11 . The method of  claim 1  further comprising introducing said catheter having said imaging bladder formed of a latex free material.  
     
     
         12 . The method of  claim 1  further comprising introducing said catheter having said imaging bladder formed of a latex material.  
     
     
         13 . The method of  claim 1  further comprising introducing a brachytherapy treatment element into the anatomical space within a vicinity of the site of medical interest and at a determined spacing from the boundary of the anatomical space so as to minimize adverse affects on the patient.  
     
     
         14 . The method of  claim 1  further comprising introducing a cryoablation treatment element into the patient at a determined spacing from the boundary of the anatomical space so as to minimize adverse affects on the patient.  
     
     
         15 . The method of  claim 1  wherein said step of operatively positioning said imaging probe of said imaging device relative to the site of medical interest and proximate portions of the anatomical space further comprises operatively positioning an ultrasonography probe into the patient until said probe is in imaging proximity to the site of medical interest.  
     
     
         16 . The method of  claim 1  further comprising introducing a PEG device into the patient at a precise location relative to the anatomical space.  
     
     
         17 . A system for precisely identifying a configuration of an anatomical space comprising: 
 a) an elongate catheter having a primary lumen and a tip structured to be inserted into an anatomical space of a patient;    b) an imaging bladder at least partially disposed about said elongate catheter in spaced relation from said tip of said catheter;    c) an inflation conduit disposed in fluid flow communication with said imaging bladder and structured to direct a fluid into said imaging bladder;    d) said imaging bladder structured to be inflated upon receipt of said fluid, and to engage and substantially conform to at least a portion of a boundary of said anatomical space;    e) an imaging device including an imaging probe structured to be disposed in operative proximity to said imaging bladder; and    f) said imaging device structured to provide a real time image of a vicinity of said imaging probe, said fluid disposed in said imaging bladder structured to define a maintainable, discernable interface with the boundary of the anatomical space visible utilizing said imaging device so as to precisely identify a location of said boundary.    
     
     
         18 . An identification system as recited in  claim 17  wherein said imaging bladder is formed from a latex free flexible material structured to minimize impedance of said real time image provided by said imaging probe.  
     
     
         19 . An identification system as recited in  claim 17  wherein said imaging bladder is formed from a flexible latex material.  
     
     
         20 . An identification system as recited in  claim 17  wherein said imaging bladder includes a wall thickness of between approximately 0.0001 inches to 0.5 inches.  
     
     
         21 . An identification system as recited in  claim 17  wherein said imaging bladder includes a wall thickness of between approximately 0.001 inches to 0.5 inches.  
     
     
         22 . An identification system as recited in  claim 17  wherein an inflated diameter of said imaging bladder is approximately 1 Fr-50 Fr.  
     
     
         23 . An identification system as recited in  claim 17  wherein said fluid is air.  
     
     
         24 . An identification system as recited in  claim 17  wherein said fluid is a radio-opaque material which defines a radiographic interface.  
     
     
         25 . An identification system as recited in  claim 17  further comprising at least one radio opaque ring disposed on said catheter.  
     
     
         26 . An identification system as recited in  claim 17  wherein said imaging bladder is approximately 4 cm in length.  
     
     
         27 . An identification system as recited in  claim 17  wherein said catheter further comprises a tip bladder disposed generally at said tip of said catheter, said tip bladder structured to be inflated once disposed in the patient to a size greater than a dimension of an entrance to an anatomical chamber so as to resist removal of said catheter.  
     
     
         28 . An identification system as recited in  claim 17  wherein said imaging device comprises an ultrasound imaging device.  
     
     
         29 . An identification system as recited in  claim 28  wherein said imaging probe comprises an ultrasonography probe structured to be inserted into the patient.  
     
     
         30 . An identification system as recited in  claim 17  wherein said inflation conduit comprises said primary lumen.