Device and method for assessing the electrical potential of cells and method for manufacture of same
OwnerJon Rice, Barry H. Hirschowitzinventors
Life of this patent
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Abstract
An apparatus and processing method for assessing the electrical potential of cells in a living organism using a high-density sensor array having a density of at least about 9 electrodes per square inch for measuring the potential of the static and quasi-static electromagnetic fields of the group of cells proximal to each electrode, where the array can be placed overlying at least a portion of a surface of a living organism with substantially all of the electrodes electrically contactable with such surface, and the surface overlying a site containing cells of clinical interest.
Claims60
An apparatus for assessing the electrical potential of cells in a living organism, said apparatus comprising:
- a high-density sensor array having a density of at least about 9 electrodes per square inch for measuring the potential of the electromagnetic fields of the group of cells proximal to each electrode, wherein said array can be placed overlying at least a portion of a surface of a living organism with substantially all of said electrodes electrically contactable with said surface, said surface overlying a site containing cells of clinical interest;
- wherein said electrodes are capable of detecting static and quasi-static electromagnetic fields of said cells.
The apparatus of claim 3, having a density of at least about 100 electrodes per square inch.
The apparatus of claim 6, wherein said electrode array has at least about 100 electrodes.
The apparatus of claim 7, wherein said electrode array has at least about 400 electrodes.
The apparatus of claim 10, wherein said cancer is breast cancer.
The apparatus of claim 10, wherein said cancer is testicular cancer.
The apparatus of claim 10, wherein said cancer is liver cancer.
The apparatus of claim 16, wherein said healing is soft tissue healing.
The apparatus of claim 16, wherein said healing is bone healing.
The apparatus of claim 24, wherein said conformable material is contoured to the shape of said surface
The apparatus of claim 24, wherein said conformable material flexes over said surface.
The apparatus of claim 28, wherein said articulated units are positionable to maintain substantially all of said electrodes in electrical contact over a non-planar surface of said living organism.
The apparatus of claim 32, wherein said conductive material has an ionic content optimized for a stable signal connection to said surface.
The apparatus of claim 34, wherein said ionic content is optimized to approximate the surface ionic content.
The apparatus of claim 33, wherein said conductive material is a stabilized conductive medium.
The apparatus of claim 38, wherein said electrodes are formed by a metal/metal chloride polymer based ink.
The apparatus of claim 39, wherein said ink contains silver/silver chloride.
The apparatus of claim 41, wherein said trace lines are formed by a conductive polymer ink by the same printing process.
The apparatus of claim 42, wherein said electrically conductive trace lines run along an extension of said non-conductive material, and away from said plurality of electrodes.
The apparatus of claim 43, further comprising a housing secured to said extension and having electrical connections spaced to match the spacing of the trace lines along said extension of said non-conductive material.
A method for assessing the clinical significance of array readings of a living organism, said method comprising the steps of:
- (a) taking a set of measurements of the electrical potential of each electrode of an array at a first surface overlying a site containing cells of clinical interest;
- (b) taking the measurement of the electrical potential of at least one other surface of said living organism as a reference at the same time as the measurement in step (a);
- (c) determining the variability of measurements of the array electrodes;
- (d) setting a normal control for patient mean values across the array;
- (e) measuring the variability of signals;
- (f) performing a convolution of each measurement at each location of the array, by averaging each array measurement with itself and its nearest neighbors, thereby generating a new set of array values;
- (g) repeating steps (b) through (f) at least three times, using the previous convoluted values as the starting measurement value for each subsequent step;
- (h) adding the differences over the array value convolution step to get an index number corresponding to the variability of measurements of the array;
- and
- (i) assessing the clinical significance of the array readings based on the number obtained in (h).
The method of claim 49, wherein said electrode array is a high-density sensor array having a density of at least about 9 electrodes per square inch.
The method of claim 49, further comprising in step (a) taking a set of measurements of the electrical potential of each electrode of an array at a second surface overlying an anatomically equivalent surface to said first surface.
The method of claim 51, wherein said anatomically equivalent surface is a bilateral symmetrical surface equivalent of said organism.
The method of claim 51, wherein said anatomically equivalent surface is the same surface measured over a time.
The method of claim 49, said each of said surfaces are equivalent surfaces of each breast of a human subject.
The method of claim 56, wherein said minimal number of false negatives is a number selected from the group consisting of a number equivalent to the false negative rate resulting from biopsy assessment, and, a number less than 1%.
A method for producing a high-density sensor array apparatus for assessing the electrical potential of cells in a living organism by measuring the potential of the electromagnetic fields of the group of cells proximal to each sensor of the apparatus, said method comprising printing a high-density array of conductive electrode lands on a non-conductive substrate, wherein said sensors are capable of detecting static and quasi-static electromagnetic fields of said cells, and forming conductive traces connecting to said lands.
Dependencies are inferred from the claim text.