Method and apparatus for sensing and processing biopotentials
First Claim
1. An apparatus for sensing and processing electropotentials from the symptomatic breast of a human female subject which includes a lesion containing quadrant and a plurality of non-lesion containing quadrants comprising:
- at least one DC biopotential reference sensor for contacting the female subject at a reference location, and each at least one DC biopotential test sensors for contacting the symptomatic breast operating with a reference sensor during a test period to detect electropotentials and to provide output test potentials, one of said test sensors forming a lesion test sensor for contact with a skin surface of the symptomatic breast over the lesion in the lesion containing quadrant and another test sensor forming a first non-lesion test sensor for contact with a skin surface of the symptomatic breast in a first non-lesion quadrant, separate from said lesion quadrant, a third of said test sensors forming a second non-lesion test sensor for contact with a skin surface of the symptomatic breast in a second non-lesion quadrant separate from said lesion and first non-lesion quadrants and a fourth of said test sensors forming a third non-lesion test sensor for contact with a skin surface of the symptomatic breast in a third non-lesion quadrant separate from said lesion and first and second non-lesion quadrants, a signal processing section being connected to separately receive the output test potentials provided by said reference sensor and lesion test sensor and said reference sensor and first, second and third non-lesion test sensors, said processing section including a processor for obtaining a first variable from said output test potentials provided by said reference sensor and lesion test sensor and a second variable by arithmetically combining all of said output test potentials provided by said reference sensor and said first, second and third non-lesion test sensors, the processor operating to subtract the second variable from the first variable to obtain a first differential value.
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Accused Products
Abstract
In accordance with the apparatus and method of the present invention, a biopotential lesion sensor is placed directly over a lesion in a symptomatic breast and a reference sensor is located away from the symptomatic breast. A plurality of electropotential test measurements are taken during a test period with the lesion sensor and averaged to obtain a primary test potential. This primary test potential can be weighted to compensate for one or more biologic variables such as patient age, time in the patient menstrual cycle, and the time of day during which the measurement is taken. To provide noise enhancement of the primary test potential average measurement, the symptomatic breast is divided into four equal quadrants with one quadrant containing the lesion. One, two or all three of the remaining three non-lesion quadrants is provided with at least one non-lesion test sensor, and during the test period a number of electropotential measurements equal to those taken by the sensor over the lesion are taken and averaged. The processor may then obtain the median value of the averages for the non-lesion quadrants or alternatively the mean value, and it will then subtract this median or mean value from the primary test potential to provide the differential value.
41 Citations
95 Claims
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1. An apparatus for sensing and processing electropotentials from the symptomatic breast of a human female subject which includes a lesion containing quadrant and a plurality of non-lesion containing quadrants comprising:
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at least one DC biopotential reference sensor for contacting the female subject at a reference location, and each at least one DC biopotential test sensors for contacting the symptomatic breast operating with a reference sensor during a test period to detect electropotentials and to provide output test potentials, one of said test sensors forming a lesion test sensor for contact with a skin surface of the symptomatic breast over the lesion in the lesion containing quadrant and another test sensor forming a first non-lesion test sensor for contact with a skin surface of the symptomatic breast in a first non-lesion quadrant, separate from said lesion quadrant, a third of said test sensors forming a second non-lesion test sensor for contact with a skin surface of the symptomatic breast in a second non-lesion quadrant separate from said lesion and first non-lesion quadrants and a fourth of said test sensors forming a third non-lesion test sensor for contact with a skin surface of the symptomatic breast in a third non-lesion quadrant separate from said lesion and first and second non-lesion quadrants, a signal processing section being connected to separately receive the output test potentials provided by said reference sensor and lesion test sensor and said reference sensor and first, second and third non-lesion test sensors, said processing section including a processor for obtaining a first variable from said output test potentials provided by said reference sensor and lesion test sensor and a second variable by arithmetically combining all of said output test potentials provided by said reference sensor and said first, second and third non-lesion test sensors, the processor operating to subtract the second variable from the first variable to obtain a first differential value. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19)
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- 20. The apparatus of clam 19 wherein said processor operates to sample and receive during a test period the same number of output test potentials from a reference test sensor and said fifth, sixth, seventh and eighth test sensors respectively as said processor samples and receives from a reference sensor and said lesion test sensor, and first, second and third non-lesion test sensors respectively.
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30. A noninvasive method for sensing and processing biopotentials from a lesion containing first quadrant of a symptomatic breast of a human female subject using a plurality of spaced biopotential sensors which includes arranging at least one reference sensor in contact with a skin surface of said subject, arranging a plurality of test sensors with at least a first of said test sensors in contact with a skin surface of the subject in said first quadrant over said lesion and a least a second test sensor in contact with a skin surface of said subject in a second quadrant of the symptomatic breast which is outside said first quadrant,
obtaining during a test period a first biopotential value using a reference sensor and said first test sensor to provide a first variable, obtaining during a test period a second biopotential value using a reference sensor and said second test sensor to provide a second variable, determining an arithmetic weighting factor in accordance with at least one physiological factor present in the human female subject during said test period, applying said arithmetic weighting factor to said first variable, and subtracting said second variable from said first variable to provide a first differential value.
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45. A noninvasive method for sensing and processing biopotentials from a lesion containing first quadrant of a symptomatic breast of a human female subject using a plurality of spaced biopotential sensors which includes arranging at least one reference sensor in contact with a skin surface of said subject, arranging a plurality of test sensors with at least a first of said test sensors in contact with a skin surface of the subject over said lesion and at least a second test sensor in contact with a skin surface of said subject in a second quadrant of the symptomatic breast which is outside said first quadrant, at least a third test sensor in contact with a skin surface in a third quadrant of said quadrants of said symptomatic breast which is outside said first and second quadrants, and at least a fourth test sensor in contact with a skin surface in a fourth quadrant of the symptomatic breast which is outside said first, second and third quadrants,
obtaining during a test period a first biopotential value using a reference sensor and said first test sensor to provide a first variable, using said reference sensor and second test sensor during the test period to obtain a second biopotential value, using said reference sensor and third test sensor during the test period to obtain a third biopotential value, using said reference sensor and fourth test sensor during the test period to obtain a fourth biopotential value, obtaining a median value of the sum of said second, third and fourth biopotential values as a second variable, and subtracting said second variable from said first variable to provide a first differential value.
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63. A noninvasive method for sensing and processing biopotentials from a lesion containing first quadrant of a symptomatic breast of a human female subject using a plurality of spaced biopotential sensors which includes arranging at least one reference sensor in contact with a skin surface of said subject, arranging a plurality of test sensors with at least a first of said test sensors in contact with a skin surface of the subject over said lesion, at least a second test sensor in contact with a skin surface of said subject in a second quadrant of the symptomatic breast which is outside said first quadrant, at least a third test sensor in contact with a skin surface in a third quadrant of said quadrants of said symptomatic breast which is outside said first and second quadrants, and at least a fourth test sensor in contact with a skin surface in a fourth quadrant of the symptomatic breast which is outside said first, second and third quadrants,
obtaining during a test period a first biopotential value using a reference sensor and said first test sensor to provide a first variable, using said reference sensor and second test sensor during the test period to obtain a second biopotential value, using said reference sensor and third test sensor during the test period to obtain a third biopotential value, using said reference sensor and fourth test sensor during the test period to obtain a fourth biopotential value, obtaining a median value of the sum of said second, third and fourth biopotential values as a second variable, and subtracting said second variable from said first variable to provide a first differential value.
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73. An apparatus for sensing and processing electropotentials from the symptomatic breast of a human female subject which includes a lesion containing quadrant and a plurality of non-lesion containing quadrants comprising:
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at least one DC biopotential reference sensor for contacting the female subject at a reference location, at least one DC biopotential test sensor for contacting the symptomatic breast and operating with a reference sensor during a test period to detect electropotentials and to provide output test potentials, one of said at least one test sensors forming a lesion test sensor for contact with a skin surface of the symptomatic breast over the lesion in the lesion containing quadrant, a signal processing section connected to receive the output test potentials provided by said reference sensor and lesion test sensor, said signal processing section including a processor for obtaining a first variable from said output test potentials provided by said reference sensor and lesion test sensor, a storage unit which stores at least one group of physiological weighting factor values which vary in value in accordance with physiological data indicative of at least one physiological factor present in the female subject, and an input unit for inputting physiological data relative to a human female subject under test to said processor, said processor operating in response to such physiological data to select a stored physiological weighting factor value determined by said physiological data and to apply said stored physiological weighting factor value to said variable. - View Dependent Claims (74, 75, 76, 77, 78, 79, 80, 81)
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82. An apparatus for screening four quadrants of a first breast of a human female subject to identify a lesion containing quadrant and non-lesion containing quadrants by sensing and processing electropotentials therefrom comprising:
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at least one DC biopotential reference sensor for contacting the female subject at a reference location, at least one DC biopotential test sensor for contacting the first breast in each quadrant thereof, each test sensor operating with a reference sensor during a screening period to form a reference-test sensor combination to detect electropotentials and provide output screening potentials, and a signal processing section connected to separately receive the output screening potentials provided by each said reference-test sensor combination during a screening period;
said signal processing section including a processor to separately receive the output screening potentials for each quadrant of the first breast and to obtain therefrom a quadrant signal value, said processor operating to compare said quadrant signal values to identify as a lesion quadrant any quadrant having a quadrant signal value which differs more than a predetermined amount from the signal values of the remaining quadrants, the remaining quadrants being identified by said processor as non-lesion quadrants.- View Dependent Claims (83, 84)
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85. An apparatus for sensing and processing electropotentials from four quadrants of a first breast and a nipple of said first breast for a human female subject comprising:
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at least one DC biopotential reference sensor for contacting the female subject at a reference location, a DC biopotential nipple sensor for contacting the nipple of said first breast and operating with said reference sensor during a test period to detect electropotentials and provide output nipple potentials, at least one DC biopotential test sensor for contacting the first breast in each quadrant thereof, each test sensor operating with said reference sensor during a test period to provide at least one reference-test sensor combination for each breast quadrant, and to detect electropotentials and provide output test potentials, and a signal processing section connected to separately receive the output nipple potentials and output test potentials, said processing section including a processor for obtaining a first variable from said output nipple potentials and operating to arithmetically combine all of said output test potentials and to obtain a second variable from the combination of all of said output test potentials, the processor operating to subtract the second variable from the first variable to obtain a first differential value. - View Dependent Claims (86)
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87. An apparatus for sensing and processing electropotentials from a test site on the skin of a human subject comprising
at least one DC biopotential reference sensor for contacting the subject at a reference location, a plurality of DC biopotential test sensors for contacting the subject at spaced locations at the test site, each said test sensor operating with a reference sensor to form a reference-test sensor combination to detect electropotentials and to provide output test potentials during a test period, at least one analog to digital converter connected to separately receive the output test potentials from each reference-test sensor combination during a test period and operating to convert said output test potentials from each reference-test sensor combination to digital test signals for said reference-test sensor combination, and a signal processing section connected to separately receive the output test potentials from each reference-test sensor combination, said signal processing section including a processor connected to separately receive the digital test signals for each said reference-test sensor combination from said analog to digital converter, and to obtain therefrom a separate digital test signal value for each said reference-test sensor combination, and a storage unit which stores a plurality of physiological weighting factor values representative of a factor having a physiological effect on said human subject connected to said processor, said processor operating at the end of a test period to combine said digital test signal values to identify at least one potential difference relationship therebetween, said processor operating to apply at least one physiological weighting factor value to said digital test signal values before arithmetically combining said digital test signal values.
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95. A method for approximating a gradient around a lesion on the symptomatic breast of a human female subject using a plurality of spaced biopotential sensors which include at least one reference sensor and at least five test sensors the method including positioning the reference sensor in contact with a skin surface of a subject,
positioning a first of the test sensors in contact with the skin surface of the subject over said lesion, positioning the remaining second, third, fourth and fifth test sensors in spaced relationship in a circle around said first test sensor with said first sensor being positioned in the center of said circle, obtaining during a test period a first biopotential value using the reference sensor and said first test sensor, obtaining during the test period a second biopotential value using the reference sensor and the second test sensor, a third biopotential value using the reference sensor and the third test sensor, a fourth biopotential value using the reference sensor and the fourth test sensor and a fifth biopotential value using the reference sensor and the fifth test sensor and subtracting from first biopotential value a value equal to one fourth the sum of the second, third, fourth and fifth biopotential values.
Specification