System for thermometry-based breast cancer risk-assessment
First Claim
1. A device for measuring surface temperatures of human breasts, comprising:
- a harness including a first contactor pad, a second contactor pad, and a securing strap means associated with said first and second contactor pads to secure one of said contactor pads concentrically on each breast of the human subject, said first contactor pad including a first array of temperature sensors exposed on a breast contact surface thereof and said second contactor pad including a second array of temperature sensors exposed on a breast contact surface thereof to provide direct contact between each sensor of the sensor arrays and the surface of the associated breast;
remote monitor means in communication with said first and second arrays of temperature sensors, to which a multiplicity of breast surface temperatures detected by the temperature sensors are communicated at predetermined intervals, and wherein such multiplicity of breast surface temperatures are stored as subject data.
1 Assignment
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Accused Products
Abstract
The system provides analogue electronic sensor means, novel mechanical harness mounting means having adjustment means and provided with remote attached monitor control means for sampling breast surface temperature and means for collecting, storing and displaying these data. The system allows breast temperatures to be measured, with great reliability, for periods of an hour or more at any desired rational sampling rate. Collected breast surface temperature data may then be downloaded into a computer for elaboration using proprietary software. Breast surface temperatures are measured at a specific point during the menstrual cycle, determined by progesterone levels in the urine. The data obtained with the instant invention under these conditions enables an investigator to determine, in women who have not reached the menopause, those who are at risk of developing breast cancer at some time in the future and those who are not at significant risk of developing the disease.
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Citations
58 Claims
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1. A device for measuring surface temperatures of human breasts, comprising:
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a harness including a first contactor pad, a second contactor pad, and a securing strap means associated with said first and second contactor pads to secure one of said contactor pads concentrically on each breast of the human subject, said first contactor pad including a first array of temperature sensors exposed on a breast contact surface thereof and said second contactor pad including a second array of temperature sensors exposed on a breast contact surface thereof to provide direct contact between each sensor of the sensor arrays and the surface of the associated breast;
remote monitor means in communication with said first and second arrays of temperature sensors, to which a multiplicity of breast surface temperatures detected by the temperature sensors are communicated at predetermined intervals, and wherein such multiplicity of breast surface temperatures are stored as subject data. - View Dependent Claims (2, 3, 4, 5, 6, 7)
when said subject data is calculated by the host computer to be higher by at least approximately 0.6°
C. than said standard breast surface temperature data, said indication means indicates the subject has a substantially higher than normal long term risk of developing breast cancer.
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4. The device of claim 3, wherein when said subject data is calculated by the host computer to be higher by at least approximately 1.2°
- C. than said standard breast surface temperature data, said indication means indicates the subject may have breast cancer.
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5. The device of claim 1, wherein each of said contactor pads includes:
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a soft, pliable inner layer having a central aperture, a front face defining said breast contact surface, and a plurality of holes therein to expose said sensors;
a soft, pliable outer layer having a central aperture concentric with said central aperture of the inner layer; and
means for attachment to said securing strap means.
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6. The device of claim 5, wherein each of said inner and outer layers includes a neoprene sheet, and said front face of said inner layer is a nylon sheet adhered to said neoprene sheet.
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7. The device of claim 5, wherein said central apertures of the inner and outer layers are larger than about 45 mm in diameter, whereby average-sized areolar areas of the breasts of said subject are not covered by said harness.
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8. A device for measuring surface temperatures of human breasts, comprising harness means provided with absolute temperature sensing means in the form of substantially similar first and second arrays each having a plurality of matched and calibrated sensor means and having connection means extending between each of said sensor means and a remote monitor means selectively connectable to an interface means, said interface means interfacing with a host computer, wherein:
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said harness means is in the form of a harness comprising first and second contactor pads disposed apart so as to provide one for each breast of a human subject and anterior and posterior joining means which also constitute securing means for securing said harness to the human subject;
said first and second arrays of matched and calibrated sensor means each being disposed apart on a breast contact surface of each of said first and second contactor pads, respectively, and arranged such that no obstruction to thermal transfer is interposed between said sensor means and said human breast surfaces, said first and second contactor pads being so constructed as to prevent heat loss from all surfaces of said sensor means not in contact with said human breast surfaces and;
said connection means comprising first and second cables in contact with said first and second contactor pads and said remote monitor means, each of said first and second cables having an outer sheathing portion and an inner portion comprising a plurality of connecting wires, one of said connecting wires from said first cable extending from each of said sensor means forming said first array to said remote monitor means and one of said connecting wires from said second cable extending from each of said sensor means forming said second array to said remote monitor means. - View Dependent Claims (9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37)
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38. A method for measuring temperatures on the surface of human breasts of a subject, comprising the steps of:
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securing a harness to a human subject using a securing strap means such that a first contactor pad of said harness is disposed upon a first breast and a second contactor pad of said harness is disposed upon a second breast such that the nipple and areolar area of each of said first and second breasts are respectively located concentrically within an inner circular hole in each of said first and second contactor pads, with a plurality of sensor can packages of a first and second sensor array caused to lie directly upon the respective skin surfaces of each of said first and second breast, and said first and second contactor pads including absolute temperature sensing means having substantially similar first and second sensor arrays, respectively;
activating a temperature monitoring cycle initiating means associated with a remote monitor means in communication with said first and second sensor arrays to initiate a temperature monitoring cycle for the collection of breast surface temperatures over a selected period during which each of a plurality of sensors of said first and second sensor arrays is polled at predetermined intervals and data so collected is stored within said remote monitor means;
at the end of said selected period of said temperature monitoring cycle, said harness is doffed by said subject and said remote monitor means is connected to an interface means of a host computer by a cable connecting means; and
downloading said stored data from said remote monitor means to said host computer under commands issued via a computer input device. - View Dependent Claims (39, 40, 41, 42, 43, 44, 45, 46)
where breast surface temperature so determined is substantially similar to said standard breast surface temperature data it may be reasonably concluded that the luteal cycle of the subject woman is present and this may indicate that there is a low long term risk of developing breast cancer;
where breast surface temperature so determined is higher by at least approximately 1°
F. or 0.6°
C. but by less than 2°
F. or 1.2°
C. than said standard breast surface temperature data it may be reasonably concluded that the luteal cycle of the subject woman is absent and this may indicate a substantially higher than normal long term risk of developing breast cancer and;
where breast surface temperature so determined is higher by approximately 2°
F. or 1.20°
C. than said standard breast surface temperature data it may be indicative of the presence of active breast cancer.
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46. The method of claim 38, further comprising the step of recharging said remote monitor means in order that said remote monitor means may be prepared for subsequent use on another subject.
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47. A device for measurement of temperatures on the surface of human breasts, comprising a system having harness means provided with temperature sensing means in the form of substantially similar first and second arrays, each of said arrays having a plurality of sensors and having connection means extending between each of said plurality of sensors and a remote monitor means selectively connectable to an interface means interfacing with a host computer means,
said harness means being in the form of a harness comprising first and second annular contactor pads, said annular contactor pads being disposed apart from one another so as to provide a means for harnessing each breast of a human subject, and further comprising anterior and posterior joining means for securing said harness to said human subject; -
said first and second annular contactor pads each being adapted by the provision of an inner circular hole having a diameter selected so as to extend at least to the areolar area of the breasts of a majority of human females when said breasts are respectively located concentrically within said inner circular holes in said first and second annular contactor pads;
said first and second arrays of sensors each being disposed apart on a breast contact surface of each of said first and second annular contactor pads respectively and arranged such that no barrier to thermal transfer is interposed between said sensor means and said human breast surfaces, said first and second annular contactor pads preventing heat loss from all surfaces of said sensor means not in contact with said human breast surfaces;
said connection means comprising first and second annular contactor pads and said remote monitor means each of said first and second cables having an outer sheathing portion and an inner portion comprising a plurality of connecting wires, each of said connecting wires from said first cable extending from each of said sensors forming said first array to said remote monitor means and each of said connecting wires from said second cable extending from each of said sensors forming said second array to said remote monitor means;
said remote monitor means comprising housing means in the form of a case provided with temperature monitoring cycle initiating means, power supply means to power an electronic means for electronically selectively polling each of said sensor means for each of said first and second arrays at rational intervals in order to collect output data therefrom, means for storing said data and downloading said data via said interface means to said host computer means;
said interface means comprising an interface between said remote monitor means and said host computer means; and
said host computer means comprising a computer and dedicated software program for the manipulation, elaboration and display of said data downloaded from said remote monitor means. - View Dependent Claims (48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58)
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Specification