Electrical impedance method and apparatus for detecting and diagnosing diseases
First Claim
1. 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 flexible arms extending from the body; 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.
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Accused Products
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.
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Citations
125 Claims
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1. An electrode array for diagnosing the presence of a disease state in a living organism, said electrode array comprising:
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a) a flexible body;
b) a plurality of flexible arms extending from the body; 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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 20, 21, 22, 23, 24, 25, 27, 28, 29)
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19. An electrode array for diagnosing the presence of a disease state in a living organism, said electrode array comprising:
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a) a flexible backing material;
b) a plurality of electrodes spaced around the backing material; and
c) means extending at least partially between the electrodes to at least partially electrically isolate the electrodes from each other.
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26. A method of confirming whether an electrode array for use in diagnosing a part of a living organism has been properly connected to an electronic module, the electrode array comprising a conductive path and a connector to link the conductive path to the electronic module, the method comprising:
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a) attaching the conductive path to a terminal of the connector;
b) connecting the electrode array to the electronic module using the connector; and
c) testing whether the conductive path is properly connected to the terminal of the connector.
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30. A template for positioning an electrode array on a part of a living organism to be diagnosed for the presence of a disease state, the template comprising:
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a) a body having a plurality of spaced parallel lines; and
b) at least two alignment marks positioned on the plurality of spaced parallel lines. - View Dependent Claims (31, 32, 33, 34, 35, 36, 38, 39, 40, 41)
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37. A method of positioning an electrode array on a part of a living organism to be diagnosed for the presence of a disease state, the electrode array positioned using a template, the template comprising a body having a plurality of spaced parallel lines and at least two alignment marks positioned on the plurality of spaced parallel lines, and the electrode array having at least two alignment marks corresponding to the alignment marks presented by the template, the method comprising:
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a) marking the living organism on or near the part to be diagnosed with a line;
b) placing the positioning template on the part to be diagnosed and aligning at least one of the spaced parallel lines to the line marked on the living organism;
c) marking on the living organism the location of the alignment marks of the template; and
d) positioning the electrode array on the part to be diagnosed by aligning its corresponding alignment marks to the markings on the living organism from the template.
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42. A connecting member for connecting an electrode array for diagnosing the presence of a disease state in a living organism to a connector that electrically links the electrode array to an electronic module, the connector member comprising:
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a) a retaining member to receive the electrode array and connector in electrical contact with respect to one another; and
b) a clamping member to clamp the electrode array and connector together and secure the electrical contact therebetween. - View Dependent Claims (43, 44, 45, 46, 47, 48, 49, 50, 51, 52)
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53. A method of connecting an electrode array for diagnosing the presence of a disease state in a living organism to a connector that electrically links the electrode array to an electronic module, the method comprising:
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a) placing the electrode array and connector in electrical contact with respect to one another; and
b) clamping the electrode array and connector together to secure the electrical contact therebetween. - View Dependent Claims (54, 55, 56, 57, 58, 60, 61, 62, 63, 64)
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59. A method of minimizing the number of connections in a conductive path of an electrode array for diagnosing the presence of a disease state in a living organism and a connector that electrically links the electrode array to an electronic module, the method comprising:
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a) providing a plurality of spaced unlinked conducting surfaces on the electrode array;
b) providing a plurality of spaced unlinked conducting surfaces on the connector, with two of the conducting surfaces selected to be connected to the conductive path; and
c) placing the electrode array and connector in electrical contact with respect to one another by overlapping the spaced unlinked conductive surfaces of the electrode array with the spaced unlinked conductive surfaces of the connector to form a continuous conductive path between the two selected conducting surfaces.
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65. A method of confirming an operable electrical contact between a plurality of spaced unlinked conducting surfaces of an electrode array and a plurality of spaced unlinked conducting surfaces of a connector, the method comprising:
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a) placing the electrode array and connector in electrical contact with respect to one another by overlapping the spaced unlinked conductive surfaces of the electrode array with the spaced unlinked conductive surfaces of the connector to form a continuous conductive path between two selected conducting surfaces; and
b) measuring a test signal over the conductive path between the two selected conducting surface to see if an operable electrical contact has been established. - View Dependent Claims (66, 67, 68, 70, 71, 72)
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69. A method of forming an electrode array for diagnosing the presence of a disease state in a living organism from a plurality of electrode array elements, wherein each electrode array element comprises a body having at least one arm extending from the body with at least one electrode provided on the arm, the method comprising:
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a) overlying the plurality of electrode array elements at the respective bodies thereof to form a main body of the electrode array with the arms of the respective electrode array elements extending from the main body in spaced relation; and
b) clamping the plurality of electrode array elements together.
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73. Apparatus for obtaining and processing impedance measurements from an electrode array for diagnosing the presence of a disease state in a living organism, the apparatus comprising:
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a) means to connect the apparatus to the electrode array;
b) means to control the connection means to produce a set of impedance measurements;
c) computer means to operate the control means; and
d) means connected to the computer means to display the impedance measurements and any analysis thereof. - View Dependent Claims (74, 75, 76, 77, 78, 79, 80, 81, 82)
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83. A method of testing a multiplexer using two substantially identical multiplexers, wherein one of the multiplexers will be reversely operated, the method comprising:
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a) connecting the respective outputs of the two multiplexers to one another;
b) providing a calibration load to the input of the reversely operating multiplexer;
c) simultaneously controlling operation of the two multiplexers through a sequence of identical output selections; and
d) measuring the calibration load at the input of the normally operating multiplexer. - View Dependent Claims (84)
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85. A method of diagnosing the possibility of a disease state in one of first and second substantially similar parts of a living organism, the method comprising:
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a) obtaining a plurality of impedance measurements across predetermined portions of each of the parts to produce first and second sets of impedance measurements, the first set for the first part and the second set for the second part, and wherein each measurement of the first set has a corresponding measurement in the second set when taken across corresponding portions of each of the parts;
b) identifying the set with a lower mean impedance value;
c) creating an absolute difference set by subtracting each measurement of the set with the lower mean impedance value from the corresponding measurement of the other set; and
d) analyzing the absolute difference set to diagnose the possibility of a disease state. - View Dependent Claims (86, 87, 88, 89, 90, 91)
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92. A method of diagnosing the possibility of a disease state in one of first and second substantially similar parts of a living organism, the method comprising:
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a) obtaining a plurality of impedance measurements across predetermined portions of each of the parts to produce first and second sets of impedance measurements, the first set for the first part and the second set for the second part, and wherein each measurement of the first set has a corresponding measurement in the second set when taken across corresponding portions of each of the parts;
b) creating a relative difference set by calculating the relative differences between each measurement from the first set with the corresponding measurement of the second set; and
c) analyzing the relative difference set to diagnose the possibility of a disease state. - View Dependent Claims (93, 94, 95, 96, 97, 98)
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99. A method of diagnosing the possibility of a disease state in one of first and second substantially similar parts of a living organism, the method comprising:
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a) obtaining a plurality of impedance measurements across predetermined portions of each of the parts to produce first and second sets of impedance measurements, the first set for the first part and the second set for the second part, and wherein each measurement of the first set has a corresponding measurement in the second set when taken across corresponding portions of each of the parts;
b) calculating an impedance range by subtracting the minimum impedance measurement from either of the first and second sets from the maximum impedance measurement from such sets;
c) creating a plurality of numbered bins by subdividing the impedance range into smaller range sizes then numbering the smaller range sizes consecutively;
d) assigning a bin number to each of the impedance measurements from the first and second sets;
e) creating a bin difference set by subtracting the bin number of each impedance measurement from one of the first and second sets from the bin number of each corresponding impedance measurement of the other set; and
f) analyzing the bin difference set to diagnose the possibility of a disease state. - View Dependent Claims (100)
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101. A method of diagnosing the possibility of a disease state in one of first and second substantially similar parts of a living organism, the method comprising:
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a) obtaining a plurality of impedance measurements across predetermined portions of each of the parts to produce first and second sets of impedance measurements, the first set for the first part and the second set for the second part, and wherein each measurement of the first set has a corresponding measurement in the second set when taken across corresponding portions of each of the parts;
b) calculating a first impedance range for the first set by subtracting the minimum impedance measurement from the maximum impedance measurement of that set, and calculating a second impedance range for the second set by subtracting the minimum impedance measurement from the maximum impedance measurement of that set;
c) creating a plurality of first numbered bins by subdividing the first impedance range into a first set of smaller range sizes then numbering the first set of smaller range sizes consecutively, and creating a plurality of second numbered bins by subdividing the second impedance range into a second set of smaller range sizes then numbering the second set of smaller range sizes consecutively;
d) assigning one of the first bin numbers to each of the impedance measurements from the first set, and assigning one of the second bin numbers to each of the impedance measurements from the second set;
e) creating a bin difference set by subtracting the bin number of each impedance measurement from one of the first and second sets from the bin number of each corresponding impedance measurement of the other set; and
f) analyzing the bin difference set to diagnose the possibility of a disease state. - View Dependent Claims (102)
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103. A method of diagnosing the possibility of a disease state in one of first and second substantially similar parts of a living organism, the method comprising:
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a) obtaining a plurality of impedance measurements taken between a predetermined plurality of points encircling the parts to produce first and second sets of impedance measurements, the first set for the first part and the second set for the second part, and wherein each measurement of the first set has a corresponding measurement in the second set when taken between a corresponding plurality of points;
b) assigning a bin number to each of the impedance measurements from the first and second sets;
c) producing a bin chord plot for each of the parts by graphically depicting the plurality of points as nodes as an encircling path for each part and the impedance measurements taken between the plurality of points as a bin chord extending between the respective nodes;
d) dividing each graphical depiction into sectors; and
e) analyzing the bin chords that converge on a given node within a sector to diagnose the possibility of a disease state. - View Dependent Claims (104, 105, 106, 107, 108, 109)
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110. A method of diagnosing the possibility of a disease state in one of first and second substantially similar parts of a living organism, the method comprising:
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a) obtaining a plurality of impedance measurements taken between a predetermined plurality of points encircling the parts to produce first and second sets of impedance measurements, the first set for the first part and the second set for the second part, and wherein each measurement of the first set has a corresponding measurement in the second set when taken between a corresponding plurality of points;
b) producing a pixel grid from a chord plot produced by the impedance measurements taken between the plurality of points; and
c) analyzing the pixel grid to diagnose the possibility of a disease state. - View Dependent Claims (111, 112, 113, 114, 115, 116, 117, 118, 119, 120, 121, 122, 123, 124, 125)
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Specification