Electrical impedance method and apparatus for detecting and diagnosing diseases

Abstract

The present invention relates to an improved method and apparatus for detecting and diagnosing disease states in a living organism by using a plurality of electrical impedance measurements. In particular, the invention provides for an improved electrode array for diagnosing the presence of a disease state in the human breast, and discloses a method of application of the array to the breast that ensures that the multiplicity of impedance measurements obtained from a first body part correspond as precisely and reproducibly as possible to the multiplicity of impedance measurements that are obtained from another, homologous, second body part. A number of diagnostic methods based on homologous electrical difference analysis are disclosed, including the calculation of a number of metrics used to indicate disease states by comparison with pre-established threshold values, and the construction of a number of graphical displays for indicating the location of disease to a body part sector.

1 - 125 . (canceled)  
     
     
         126 . An electrode array for diagnosing the presence of a disease state in a living organism, said electrode array comprising: 
 a) a flexible body;    b) a plurality of elongate flexible arms extending from the body, the flexible arms constructed of a material that when flexed in one direction is relatively inflexible in other directions; and    c) a plurality of electrodes provided by the plurality of flexible arms, wherein the electrodes are arranged on the arms to obtain impedance measurements between respective electrodes.    
     
     
         127 . An electrode array according to  claim 126  wherein the plurality of flexible arms are spaced around the flexible body.  
     
     
         128 . An electrode array according to  claim 127  wherein each of the plurality of flexible arms is provided with an electrode pair.  
     
     
         129 . An electrode array according to  claim 128  wherein the flexible body is provided with a stiffening member adapted to flatten part of the tissue of the living organism being diagnosed.  
     
     
         130 . An electrode array according to  claim 129  wherein the stiffening member is in the form of a ring.  
     
     
         131 . An electrode array according to  claim 129  wherein the stiffening member includes adhesive for fixation to the skin.  
     
     
         132 . An electrode array according to  claim 126  wherein each electrode comprises an adhesive for fixation to the skin.  
     
     
         133 . An electrode array according to  claim 132  wherein the adhesive is an adhesive hydrogel.  
     
     
         134 . An electrode array according to  claim 132  wherein the adhesive is a gel foam pad.  
     
     
         135 . An electrode array according to  claim 134  wherein the gel foam pad forms a well that is filled with hydrogel.  
     
     
         136 . An electrode array according to  claim 126  wherein the flexible body and the flexible arms are comprised of a polyester film.  
     
     
         137 . An electrode array according to  claim 126  further comprising means extending at least partially between the electrodes to at least partially electrically isolate the electrodes from each other.  
     
     
         138 . An electrode array according to  claim 137  wherein said means comprises a ground conductive path.  
     
     
         139 . An electrode array according to  claim 138  wherein each of the plurality of flexible arms is provided with an electrode pair and each electrode pair is comprised of a current electrode and a voltage electrode.  
     
     
         140 . An electrode array according to  claim 139  wherein the ground conductive path extends at least partially between the current electrode and voltage electrode.  
     
     
         141 . An electrode array according to  claim 140  wherein each electrode is connected to an associated terminal by a conductive path.  
     
     
         142 . An electrode array according to  claim 141  wherein the ground conductive path extends at least partially between the conductive paths of respective electrodes to at least partially electrically isolate the conductive paths from each other.  
     
     
         143 . An electrode array according to  claim 142  wherein the ground conductive path extends at least partially between the terminals of respective electrodes to at least partially electrically isolate the terminals from each other.