Method and apparatus for noninvasive intraductal fluid diagnostic screen

Abstract

Disclosed is a method and apparatus for accomplishing a noninvasive screen for breast disease markers, including breast cancer markers and cytologically abnormal cells. Intraductal fluid is noninvasively aspirated using compression, heating and suction cycles. The removed sample is thereafter assayed for the presence of cytologically abnormal cells and/or one or more breast disease markers. In addition to the diagnostic applications of the disclosed method and apparatus, a therapeutic application is also contemplated wherein intraductal fluids are noninvasively aspirated using compression, heating and suction cycles to remove toxic buildups within the fluid.

1 . An intraductal fluid withdrawal system, comprising: 
 a control unit;    a patient interface unit;    a control line extending between the control unit and the patient interface unit; and    a closed fluid circulation loop, having a first component removably carried by the control unit and a second component carried by the patient interface unit.    
   
   
       2 . An intraductal fluid withdrawal system as in  claim 1 , wherein the first component comprises a reservoir.  
   
   
       3 . An intraductal fluid withdrawal system as in  claim 2 , wherein the circulation loop comprises a movable wall.  
   
   
       4 . An intraductal fluid withdrawal system as in  claim 3 , wherein the circulation loop comprises a compressible tube.  
   
   
       5 . An intraductal fluid withdrawal system as in  claim 1 , wherein the second component comprises an inflatable bladder.  
   
   
       6 . An intraductal fluid withdrawal system as in  claim 5 , wherein the bladder comprises at least 3 inflatable lobes.  
   
   
       7 . An intraductal fluid withdrawal system as in  claim 6 , comprising at least 6 inflatable lobes.  
   
   
       8 . An intraductal fluid withdrawal system as in  claim 1 , further comprising a heat exchange fluid contained within the closed loop.  
   
   
       9 . An intraductal fluid withdrawal system as in  claim 6 , wherein each lobe has an inflated width of no more than about 3 inches and an inflated length of no more than about 4 inches.  
   
   
       10 . An intraductal fluid withdrawal system as in  claim 9 , wherein each lobe has an inflated width of no more than about 2 inches and an inflated length of no more than about 3 inches.  
   
   
       11 . An intraductal fluid withdrawal system as in  claim 6 , wherein each lobe has an inflated thickness of no more than about 1 inch.  
   
   
       12 . An intraductal fluid withdrawal system as in  claim 11 , wherein each lobe has an inflated thickness of no more than about 0.5 inches.  
   
   
       13 . An intraductal fluid withdrawal system as in  claim 1 , further comprising a heat source in the control unit.  
   
   
       14 . An intraductal fluid withdrawal system as in  claim 13 , wherein the first component is removably in thermal communication with the heat source.  
   
   
       15 . An intraductal fluid withdrawal system as in  claim 1 , further comprising a pump in the control unit.  
   
   
       16 . An intraductal fluid withdrawal system as in  claim 15 , wherein the fluid circulation loop is positioned such that the pump causes fluid circulation through the loop.  
   
   
       17 . An intraductal fluid withdrawal system as in  claim 1 , further comprising a support in the patient interface unit, for supporting the second component in compressive contact with the patient.  
   
   
       18 . An intraductal fluid withdrawal system as in  claim 17 , wherein the support is adjustable.  
   
   
       19 . An intraductal fluid withdrawal system as in  claim 1 , further comprising a disposable patient interface carried by the patient interface unit, for contacting the patient.  
   
   
       20 . An intraductal fluid withdrawal system as in  claim 1 , wherein the disposable patient interface comprises a flexible polymeric membrane.