Method and kit for obtaining fluids and cellular material from breast ducts

Abstract

Methods, kits, and apparatus for obtaining cellular, chemical, and other materials from breast ducts are described. A single milk duct is accessed and washed with a washing fluid to obtain marker materials from the lining the duct. The washing fluid is then collected, and the marker materials in the washing fluid identified and analyzed. Usually, the washing fluid is introduced using a syringe through a lumen of a dual-lumen catheter. The ductal volume is filled with the washing fluid and excess fluid flows outwardly through a second lumen of the dual-lumen catheter, from which it is collected.

What is claimed is:  
     
         1 . A method for obtaining material from a milk duct in a breast of a patient, said method comprising: 
 (a) locating a single milk duct;    (b) introducing a washing fluid substantially throughout the duct without rupture;    (c) collecting at least a portion of the washing fluid from the duct; and    (d) identifying materials in the washing fluid collected from the duct.    
     
     
         2 . A method as in    claim 1   , further comprising obtaining material from at least one additional single mile duct of the same breast by repeating steps (a) through (d) on another single milk duct.  
     
     
         3 . A method as in    claim 2   , wherein the steps are repeated for all ducts in the nipple.  
     
     
         4 . A method as in    claim 1   , wherein the materials identified in the washing fluid include ductal epithelial cells.  
     
     
         5 . A method as in    claim 4   , further comprising examining the morphology of the epithelial cells in the washing fluid to determine if they are atypical in order to assess the likelihood of a cancer present in the cellular lining of the duct.  
     
     
         6 . A method as in    claim 1   , wherein the materials comprise molecular species.  
     
     
         7 . A method for obtaining material from a milk duct in a breast of a patient, said method comprising: 
 (a) locating at least one of the ductal orifices on a nipple of the breast;    (b) introducing a catheter having at least one lumen through one of the ductal orifices and into the ductal passage;    (c) introducing a washing fluid through a lumen into the ductal passage;    (d) collecting the washing fluid from the ductal passage through a lumen of the catheter; and    (e) identifying materials present in the collected washing fluid.    
     
     
         8 . A method as in    claim 7   , further comprising dilating the ductal orifice prior to introducing the catheter.  
     
     
         9 . A method as in    claim 7   , wherein the catheter includes at least two lumens and washing fluid introducing and collecting steps are performed through separate lumens in the catheter.  
     
     
         10 . A method as in    claim 9   , wherein a preselected volume of the washing fluid is introduced to the duct through one lumen and excess volume flows out of the duct through another catheter lumen.  
     
     
         11 . A method as in    claim 10   , wherein the volume of washing fluid is at least 5 ml.  
     
     
         12 . A method as in    claim 8   , wherein the volume of washing fluid is at least 10 ml.  
     
     
         13 . A method as in    claim 7   , further comprising obtaining and identifying material from at least one additional single milk duct of the same breast by repeating steps (a) through (e) on another single milk duct.  
     
     
         14 . A method as in    claim 13   , wherein the steps are repeated for all ducts in the nipple.  
     
     
         15 . A method as in    claim 6   , wherein the material in the washing fluid include epithelial cells.  
     
     
         16 . A method as in    claim 15   , further comprising examining the morphology of the epithelial cells in the washing fluid to determine if they are atypical in order to assess the likelihood of a cancer present in the cellular lining of the duct.  
     
     
         17 . A method as in    claim 7   , wherein the materials comprise molecular species.  
     
     
         18 . A kit for obtaining material from a milk duct of a breast, said kit comprising: 
 a catheter; and    instructions setting forth a method for use of the dual-lumen catheter according to    claim 7   .