Methods and apparatus for determining fallopian tube occlusion

Abstract

Devices and methods for determining fallopian tube occlusion. The methods may include determining fallopian tube occlusions through a pressurization or volumetric determination.

What is claimed: 
     
         1 . A system for determining fallopian tube occlusion comprising:
 means for distending a uterus with a first fluid, the uterus including a first cornua of a first fallopian tube;   means for coupling a device to the first cornua to fluidly separate a first sealed portion of the first cornua from the remainder of the distended uterus;   means for evacuating a first volume of the first fluid from the first sealed portion;   means for measuring the first volume of the first fluid;   means for supplying a second fluid to the first sealed portion;   means for measuring a second volume of the second fluid supplied to the first sealed portion;   means for comparing the first volume of the first fluid to the second volume of the second fluid to determine if the first fallopian tube is occluded.   
     
     
         2 . The system of  claim 1 , wherein the first fallopian tube is determined to be occluded if the second volume is within 10% of the first volume. 
     
     
         3 . The system of  claim 1 , wherein means for measuring the first volume comprise a marked syringe. 
     
     
         4 . The system of  claim 1 , wherein the means for measuring the second volume comprise a marked syringe. 
     
     
         5 . The system of  claim 1 , wherein measuring the first volume comprises measuring 1 cc or less. 
     
     
         6 . The system of  claim 1 , wherein the device comprises a first catheter, and coupling the device to the first cornua to fluidly separate the first sealed portion of the first cornua from the remainder of the distended uterus comprises:
 expanding a first balloon end portion of the first catheter against the first cornua to engage the first cornua.   
     
     
         7 . The system of  claim 6 , further comprising:
 means for expanding the first balloon end portion with a single air or fluid source.   
     
     
         8 . The system of  claim 6 , further comprising:
 means for applying a vacuum to a first vacuum cavity in the first balloon end portion to further engage the first cornua.   
     
     
         9 . The system of  claim 1 , wherein the means for coupling the device to the first cornua to fluidly separate the first sealed portion of the first cornua from the remainder of the distended uterus comprise:
 means for expanding a uterine balloon and engaging the first cornua with the expanded uterine balloon.   
     
     
         10 . The system of  claim 1 , wherein the second fluid is not soluble with the first fluid. 
     
     
         11 . A catheter for use in a system for determining fallopian tube occlusion, comprising:
 an elongated flexible portion having a proximal end and a distal end, the distal end configured for fluidly sealing a cornua of a fallopian tube in a uterus from the remainder of the uterus, the elongated flexible portion comprising:
 an inflatable portion at the distal end, the inflatable portion configured to seal the cornua from the uterus when the inflatable portion is inflated; 
 a first lumen configured to receive a first fluid at the proximal end and deliver a first volume of the first fluid to the sealed cornua at the distal end; 
 a second lumen configured to evacuate at least a portion of the first volume of the first fluid at the distal end and evacuate the at least a portion of the first volume of the first fluid from the sealed cornua. 
   
     
     
         12 . The catheter of  claim 11 , wherein the inflatable portion comprises:
 first and second radial portions extending in a substantially perpendicular direction transverse to the longitudinal axis of the elongated flexible portion, wherein the first and second radial portions form a substantially circular vacuum space between the catheter a wall of the cornua and are configured to engage the wall of the cornua.   
     
     
         13 . The catheter of  claim 12 , wherein the elongated flexible portion further comprises one or more additional lumens fluidly coupled to the substantially circular vacuum space, wherein the one or more additional lumens are configured to provide a vacuum source to the substantially circular vacuum space. 
     
     
         14 . The catheter of  claim 12 , further comprising:
 a biocompatible adhesive on the outer circumference of one or both of the first and second radial portions where the radial portions engage the wall of the cornua.   
     
     
         15 . A system for determining fallopian tube occlusion comprising:
 an elongated substantially circular outer sheath configured for insertion into a uterus;   an outer sheath balloon surrounding a circumference of the outer sheath, the outer sheath balloon configured to fluidly seal the uterus when inflated;   a first and a second catheter substantially enclosed by the outer sheath, each catheter comprising:
 an elongated flexible portion having a proximal end and a distal end, the distal end configured for fluidly sealing a cornua of a fallopian tube in the uterus, the elongated flexible portion including:
 an inflatable portion at the distal end, the inflatable portion configured to fluidly seal the cornua from the uterus when the inflatable portion is inflated; 
 a first lumen configured to receive a first fluid at the proximal end and deliver a first volume of the first fluid to the fluidly sealed cornua at the distal end; 
 a second lumen configured to evacuate at least a portion of the first volume of the first fluid at the distal end and the second lumen is further configured to deliver the evacuated at least a portion of the first volume of the first fluid to the proximal end of the second lumen. 
 
   
     
     
         16 . The system of  claim 15 , wherein the proximal end of the second lumen is further configured for coupling to a measuring means, and the measuring means comprises a marked syringe. 
     
     
         17 . The system of  claim 15 , further comprising:
 a first fluid source coupled to the proximal end of the first lumen of each of the first and second catheters.   
     
     
         18 . The system of  claim 15 , wherein each catheter further comprises:
 first and second radial portions extending in a substantially perpendicular direction transverse to the longitudinal axis of the elongated flexible portion, wherein the first and second prominent radial portions form a substantially circular vacuum space, configured to engage a wall of a cornua of the uterus.   
     
     
         19 . The system of  claim 18 , wherein the elongated flexible portion of each catheter further comprises one or more additional lumens fluidly coupled to the substantially circular vacuum space, wherein the one or more additional lumens are configured to provide a vacuum source to the substantially circular vacuum space. 
     
     
         20 . The system of  claim 19 , further comprising:
 a vacuum source coupled to the proximal end of the one or more additional lumens within each catheter.   
     
     
         21 . The system of  claim 15 , further comprising:
 a biocompatible adhesive on the outer circumference of at least one of the first and second radial portions of each catheter, where the radial portions engage the wall of the cornua.   
     
     
         22 . The system of  claim 15 , wherein the further comprising:
 a spring mechanism disposed between the first and catheter, the spring mechanism configured to expand the first and second catheters into a Y-position to facilitate placement of each of the first and second catheters into a respective first and second cornua of the uterus; and   a retractable member coupled to the spring mechanism, wherein the retractable member is configured to activate the first and second catheters into the Y-position, or retract the spring mechanism so that the first and second catheters are in a closed or collapsed position.