Method and apparatus for measuring factors in mammary fluids

Abstract

The present invention relates generally to breast fluid aspirators, and more specifically to an apparatus, a system, and a method for determining the risk of breast disease in a biological sample obtained for the breast by means of a breast fluid aspirator.

What is claimed is:  
     
         1 . A method for detecting a biological factor in a fluid sample obtained from a mammary gland, comprising the steps of: 
 non-invasively obtaining a mammary gland fluid from a subject comprising 
 warming the mammary gland;  
 massaging the mammary gland;  
 extracting the mammary fluid from the nipple by expression or aspiration; and  
 detecting the biological factor in the mammary gland fluid.  
   
     
     
         2 . The method of  claim 1 , further comprising the steps of: 
 expressing the mammary fluid by placing thumb and first fingers behind the nipple forming a C-hold;    pushing the nipple into the chest wall; and    rolling thumb and fingers forward toward the nipple.    
     
     
         3 . The method of  claim 1 , further comprising the steps of: 
 applying a nipple aspirator unit to the nipple, the nipple aspirator comprising: 
 a nipple receiving unit having a nipple receiving end and a vacuum attachment end;  
 a vacuum source;  
 a vacuum line having a first and second end wherein the first end is connected to the nipple receiving unit at the vacuum attachment end and the second end is connected to the vacuum source such that the vacuum source is in vacuum communication with the nipple receiving end of the nipple receiving unit.  
   
     
     
         4 . The method of  claim 1 , wherein the biological factor is selected from the group consisting of a nucleic acid, a protein, a peptide, a glycoprotein, a lipid and a biochemical product.  
     
     
         5 . The method of  claim 4 , wherein the nucleic acid is DNA or RNA.  
     
     
         6 . The method of  claim 4 , wherein the biochemical product is β-carotene or a derivative thereof.  
     
     
         7 . The method of  claim 6 , wherein the biochemical product is detected by chromatography.  
     
     
         8 . The method of  claim 1 , wherein the biological factor is detected by employing a probe that specifically interacts with the biological factor.  
     
     
         9 . The method of  claim 8 , wherein the probe is selected from the group consisting of a monoclonal antibody, a polyclonal antibody, and a nucleic acid.  
     
     
         10 . The method of  claim 6 , wherein the biochemical product is a carotenoid.  
     
     
         11 . The method of  claim 1 , wherein the step of massaging the mammary gland comprises massaging the mammary gland from the chest wall towards the areola or nipple.  
     
     
         12 . The method of  claim 1 , wherein the subject is a mammal.  
     
     
         13 . The method of  claim 12 , wherein the mammal is a human.  
     
     
         14 . The method of  claim 1 , wherein the method further comprises warming the mammary gland prior to massaging.  
     
     
         15 . The method of  claim 1 , wherein the subject is administered oxytocin prior to massaging the mammary gland.  
     
     
         16 . The method of  claim 3 , wherein the nipple receiving unit has a tubular shape with a nipple receiving end designed to receive a nipple.  
     
     
         17 . The method of  claim 3 , wherein the vacuum source is a syringe.  
     
     
         18 . The method of  claim 3 , wherein the vacuum source is a vacuum pump.  
     
     
         19 . The method of  claim 3 , wherein the vacuum source is a wall vacuum.  
     
     
         20 . The method of  claim 3 , wherein the nipple receiving unit comprises an inner tube and an outer tube, wherein the inner tube and the outer tube are coaxial.  
     
     
         21 . The method of  claim 3 , the nipple aspirator unit further comprising a breast shield having the nipple receiving unit concentrically positioned in the breast shield.  
     
     
         22 . The method of  claim 21 , wherein the breast shield further comprises a vibrating element.  
     
     
         23 . The method of  claim 21 , wherein the breast shield further comprises a massaging unit.  
     
     
         24 . The method of  claim 1 , further comprising applying a nipple aspirator unit to the nipple, the nipple aspirator comprising: 
 a pliable mammary gland shield configured to fit snugly over the mammary gland of the subject, the shield having a massaging element configured to provide physical stimuli to the mammary gland;    a nipple receiving unit centered radially in the mammary gland shield, wherein the nipple receiving unit comprises a tubular shape with a nipple receiving end designed to receive a nipple and a second vacuum attachment end for attachment to a vacuum line;    a vacuum line, the vacuum line having a first end and a second end, the first end being connected to the nipple receiving unit; and    a vacuum source for creating a vacuum connected to the second end of the vacuum line, wherein the vacuum source is in vacuum communication with the nipple receiving end of the nipple receiving unit.    
     
     
         25 . The method of  claim 24 , wherein the massaging element is a vibrating element.  
     
     
         26 . The method of  claim 24 , wherein the massaging element delivers a peristaltic action, wherein the mammary gland is massaged from the chest wall to the nipple.  
     
     
         27 . The method of  claim 24 , wherein the vacuum source is a syringe.  
     
     
         28 . The method of  claim 24 , wherein the vacuum source is a vacuum pump.  
     
     
         29 . The method of  claim 24 , wherein the vacuum source is a wall vacuum.  
     
     
         30 . The method of  claim 1 , wherein the mammary gland fluid is a breast milk.  
     
     
         31 . The method of  claim 30 , wherein the breast milk is a colostrum breast milk.