Disease Detection Device and Method for Detection of Abnormal Immunological Activity
20180279940 ยท 2018-10-04
Inventors
Cpc classification
A61B5/41
HUMAN NECESSITIES
A61B5/0059
HUMAN NECESSITIES
A61B5/0077
HUMAN NECESSITIES
A61B2562/0233
HUMAN NECESSITIES
G01V3/08
PHYSICS
A61B5/70
HUMAN NECESSITIES
A61B5/01
HUMAN NECESSITIES
International classification
A61B5/00
HUMAN NECESSITIES
A61B5/01
HUMAN NECESSITIES
G01V3/08
PHYSICS
Abstract
A disease detection device and method for detection or diagnosis of abnormal immunological activity is disclosed. The device is configured to detect the surface temperature of one or more hominid fingernails, thumbnails, or toenails by non-contact means and compare the temperature(s) detected to at least one second non-contact temperature measurement from the same subject, or to the nominal internal body temperature of the subject. The temperatures could be detected by non-contact electronic sensors, thermo-sensitive linear array sensors, or two-dimensional thermographic imagers. The device further comprises a computing device which executes instructions to compare the nail temperature(s) to the other temperature(s). The magnitude and polarity of the temperature difference of the nail(s) to the other temperature measurement(s) or the nominal internal body temperature of the subject indicates the presence of various pathological states, especially autoimmune, acute immune, drug-induced pathology, and various neurological, circulatory, traumatic, arthritic, and local infectious disorders of the hand.
Claims
1. A disease detection device, comprising: a housing with an opening at a front end thereof to enable a user to insert a digit without contacting the housing, wherein the housing comprises a top side, a bottom side opposite to the top side, a first side and a second side disposed opposite to the first side; a digit detection unit disposed within the housing is configured to detect presence of a digit; at least two temperature sensors disposed within the housing comprising, a first temperature sensor disposed at the top side of the housing for measuring a temperature of a nail surface of a user, a second temperature sensor disposed at the bottom side of the housing for measuring a temperature of a skin surface of a pad of the user; wherein the housing is configured to shield the first and second temperature sensor from infrared light; a computing device in communication with the detection unit and at least two temperature sensors is configured to receive and analyze the nail surface temperature and skin surface temperature for magnitude and polarity to detect the presence of pathological condition of the user.
2. The disease detection device of claim 1, wherein the housing of the device is composed of lightweight non-conductive plastic and a plurality of electronic circuits in the device is made from fiberglass material so that the disease detection device weighs no more than one pound.
3. The disease detection device of claim 1, further comprising an infrared sensor assembly.
4. The disease detection device of claim 1, wherein the housing further comprises a slot for receiving the nail of the user.
5. The disease detection device of claim 1, wherein the digit detection unit is a mechanical switch.
6. The disease detection device of claim 1, wherein the digit detection unit is an ultrasonic digit detection unit.
7. The disease detection device of claim 1, wherein the digit detection unit is a capacitive sensing unit.
8. The disease detection device of claim 1, wherein the digit detection unit is a light beam interruption device.
9. The disease detection device of claim 8, wherein the light beam interruption device comprises at least one light emitter diode disposed at the first side of the housing is configured to emit light; and at least one light-sensitive phototransistor disposed at the second side of the housing is configured to detect interruption of light emitted from the at least one diode to detect the presence of finger.
10. A method to detect a presence of pathological condition of user, comprising steps of: providing a disease detection device, comprising a measurement area for receiving a digit of a user, a digit detection unit for sensing the presence of a digit in the measurement area, a first temperature sensor for measuring a temperature of a nail surface of the user, a second temperature sensor for measuring a temperature of a skin surface of a pad of the user, and a computing device in communication with the first and the second temperature sensors and the digit detection unit, configured to provide instruction to user to aid during a test procedure; providing instruction to the user to undergo a vasoconstricted state; inserting one digit at a time into the measurement area; sensing the presence of a digit by the detection unit; receiving a signal indicating the presence of the digit in the measurement area for measuring temperature data of the finger; measuring a temperature of the nail surface and the skin surface of the user; and analyzing the temperature of the nail surface and the skin surface by the computing device for magnitude and polarity to detect the presence of pathological condition of the user.
11. The method of claim 10, wherein the user undergoes the vasoconstricted state by resting in an area of ambient temperature at least 20 F. (11.1 C.) below the nominal body temperature of the user.
12. The method of claim 10, wherein the step of measuring temperature of nail surface and skin surface of the user is performed in all fingers of the user.
13. The method of claim 10, wherein if the finger of the user is amputated, the computing device is configured to instruct the user to place a different finger.
14. A disease detection device, comprising: an enclosure with an opening at a front end thereof to enable a user to insert a hand or foot without contacting the enclosure, wherein the enclosure comprises a top side, a bottom side opposite to the top side, a first side and a second side disposed opposite to the first side; an extremity detection unit disposed within the enclosure is configured to detect presence of an extremity; a plurality of thermal imagers disposed within the enclosure comprising, a first thermal imager disposed at the top side is configured to detect a nail surface temperature, a second thermal imager disposed at the bottom side is configured to detect a pad temperature, and a third thermal imager disposed at the first side and a fourth thermal imager disposed at the second side the plurality configured to detect at least one of a nail surface or finger pad temperature; and a computing device in communication with the plurality of thermal imagers and the extremity detection unit is configured to analyze nail surface temperatures and pad temperatures from the plurality of thermal imagers to detect the presence of a pathological condition of the user.
15. The disease detection device of claim 14, wherein the enclosure comprises non-reflective, high-emissivity, uniform inner surface.
16. The disease detection device of claim 14, further comprises means to measure an ambient temperature by imaging the inner surface of the enclosure.
17. The disease detection device of claim 14, wherein the plurality of thermal imagers are configured to be re-calibrated to a single standard temperature by imaging the inner surface of the enclosure.
18. The disease detection device of claim 14, wherein the detection unit is at least any one of a light beam interruption device, ultrasonic digit detection unit, and capacitive sensing unit.
19. A method to detect a presence of pathological condition of user, comprising steps of: providing a disease detection device, comprising a measurement area for receiving an extremity of a user, a detection unit for sensing the presence of an extremity in the measurement area, a plurality of thermal imagers disposed within the housing comprising, a first thermal imager configured to detect a nail surface temperature, a second thermal imager configured to detect a pad temperature, and a computing device in communication with the detection unit and at least two thermal imagers configured to provide instruction to user to aid during diagnosis; providing instruction to the user to undergo a vasoconstricted state; placing a first unclasped extremity within the measurement area in unclasped state for radiometrically imaging via the at least two thermal imagers; placing a second unclasped extremity within the measurement area for radiometrically imaging via the at least two thermal imagers; transmitting a thermal image data of the first and second extremity of the user to the computing device; comparing the thermal image data of the first and second extremity with a nominal body core temperature of a user by the computing device; and providing result regarding the presence of pathological condition to the user.
20. The method according to claim 19, wherein the user undergoes the vasoconstricted state by resting in an area of ambient temperature at least 20 F. (11.1 C.) below the nominal body temperature of the user.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] The previous summary and the following detailed descriptions are to be read in view of the drawings, which illustrate particular exemplary embodiments and features as briefly described below. The summary and detailed descriptions, however, are not limited to only those embodiments and features explicitly illustrated.
[0016]
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[0020]
[0021]
[0022]
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[0025]
DETAILED DESCRIPTIONS
[0026] These descriptions are presented with sufficient details to provide an understanding of one or more particular embodiments of broader inventive subject matters. These descriptions expound upon and exemplify particular features of those particular embodiments without limiting the inventive subject matters to the explicitly described embodiments and features. Considerations in view of these descriptions will likely give rise to additional and similar embodiments and features without departing from the scope of the inventive subject matters. Although the term step may be expressly used or implied relating to features of processes or methods, no implication is made of any particular order or sequence among such expressed or implied steps unless an order or sequence is explicitly stated.
[0027] Any dimensions expressed or implied in the drawings and these descriptions are provided for exemplary purposes. Thus, not all embodiments within the scope of the drawings and these descriptions are made according to such exemplary dimensions. The drawings are not made necessarily to scale. Thus, not all embodiments within the scope of the drawings and these descriptions are made according to the apparent scale of the drawings with regard to relative dimensions in the drawings. However, for each drawing, at least one embodiment is made according to the apparent relative scale of the drawing.
[0028] As will be discussed in more detail infra, this application discloses various embodiments of a disease detection device and method for diagnosis of abnormal immunological activity. The present invention involves acquiring temperature data of nails and comparing the nail temperature with core body temperature or a skin surface temperature of the body to detect the presence of pathological condition. In many embodiments of the present invention, the device comprises single-thermopile or other chip devices, linear thermal arrays, or two-dimensional thermal arrays connected to a device that conveniently gathers the temperature data of fingernail and other temperature data. The device further comprises means to compute the temperature difference, and then displays the temperature differential in either analog or digital form automatically. Also, by examining the temperature data taken from multiple digits or nails, strong correlations to immune disease, drug reaction or other neurologic, circulatory, traumatic, or infectious processes may be computed and displayed without the need for a skilled human interpreter.
[0029]
[0030]
[0031] In the same embodiment, as shown in
[0032]
[0033] The sensor Z2 is aimed to detect the surface temperature of the volar finger pad of the same finger as Z1. The thermistor inside the case of Z2 forms a voltage divider with resistor R13. As the resistance of the internal thermistor of Z2 decreases with increasing case temperature, the voltage output from the voltage divider consisting of Z2 and R13 is negatively correlated with the case temperature of Z2 and is wired into the inverting input of instrumentation amplifier I2. The infrared-sensitive thermopile in Z2 produces a voltage proportional to the temperature difference produced by infrared radiation heating the front surface of the thermopile chip as compared to the temperature of the back surface of the chip which is monitored by the thermistor in Z2. The voltage generated by the thermopile is much smaller than the voltage produced by the thermistor inside Z2 and must be amplified by a factor of around 1000 by the precision noninverting operational amplifiers I4A&B so that the voltage output amplitude from I4B matches that of the output of the Z2-R13 voltage divider. As the thermal sensitivity of the thermopile in Z2 is dependent on factors such as the distance and orientation between the surface being measured and the case of Z2 and may vary from unit-to-unit, the amplification factor of I4A&B must be adjustable. This is accomplished by the variable resistor R15 (GAIN-P). The amplified voltage signal from I4B is wired to the non-inverting input of instrumentation amplifier I2. Instrumentation amplifier I2 subtracts the negatively correlated thermistor voltage from the positively correlated thermopile output from I4B to produce a voltage output labelled TPAD (temperature of digit pad) which is positively and linearly correlated with the actual surface temperature of the volar pad inserted into the device, independent of the case temperature of Z2. Voltage TPAD may be scaled so that a second meter 218 (shown in
[0034] The digit detection unit sends signal FSW to the microprocessor, indicating the fingertip has been inserted between the two infrared sensors Z1 and Z2. Then the two temperature values TNAIL and TPAD are digitized by the Analog-to-Digital Converter 16 and stored in the microprocessor memory. Then TNAIL and TPAD are analyzed for magnitude and polarity and the results are used to detect the possible presence of pathological conditions. Signal FSW may also be used to display TNAIL and TPAD on first 216 and second meters 218, and then hold these values on the meters for reading. In an embodiment, the fingertip detection unit is at least any one of a mechanical pushbutton, capacitive sensing unit, ultrasonic digit detection unit or light beam interruption device. Referring to
[0035] The optical axis between D1 and Q2 is at right angles to the axis between the thermal detectors Z1 and Z2 to reduce any interference with thermal measurement. Such interference is further reduced by the filter windows built in to Z1 and Z2, which block visible or near-infrared (NIR) light from reaching the thermopile chips in these devices. The optical axis between D1 and Q2 is located so that the bed of the nail is directly below Z1 when the light beam between D1 and Q2 is interrupted. The NIR Finger Detector PCB 220 contains a slot 222 to accommodate a long nail, allowing the fleshy tip of the digit to touch the board. This assures that the nail bed is directly under the thermal sensor Z1 and the digit pad is directly above the thermal sensor Z2 at the time of the temperature measurement.
[0036]
[0037] A LM555 Timer integrated circuit I1 is connected to produce a negative-going 1-millisecond pulse every 150 milliseconds. Each short negative pulse turns on the P-channel MOSFET transistor Q1, energizing the near-infrared (NIR) emitting diode D1. D1 is oriented to send the short pulses of light toward the NIR-sensitive phototransistor Q2. The pulse of light turns Q2 ON, driving the input of inverter I3 high. The output of inverter I3 thus goes low. A circuit consisting of D2, R4, and C5 delays the input of inverter I2 going low until the output of inverter I3 settles high or low. When the output of inverter I2 goes high, it latches the output of inverter I3 into the FSW output of the integrated circuit latch I4. When the output of inverter I2 goes low at the end of the 1-millisecond pulse from I1, the FSW signal is latched by I4 and cannot change until output of inverter I2 goes HIGH again. Thus, when an opaque object such as a fingertip blocks the light transmission from D1 to Q2, the output signal FSW goes high for as long as the light beam is blocked, then FSW returns and stays low when the opaque object is removed from the light path.
[0038] In at least one embodiment of the invention, the device is configured to be highly light-weight and portable so that a frail patient or caregiver could easily maneuver and operate it. In such embodiments, the materials comprising the housing of the device are non-conductive plastic. In at least one embodiment, Acrylonitrile-Butadiene-Styrene is used for the case for device 200 and sensor housing 202 and a fiberglass printed circuit 300 for light weight and electrical insulation such that the entire weight of the device weighs no more than 1 lb. (480 gm).
[0039] In at least one embodiment, the present invention provides a method for detecting the presence of pathological conditions. The disease detection accuracy and specificity of the invention as described can be further enhanced by repeating the described temperature difference detection on all the subject's digits, then via either manual or computerized means, computing an average value and polarity of the nail-to-pad and nail-to-core body temperatures, a maximum value and polarity of the nail-to-pad and nail-to-core body temperatures, the number of nail-to-pad and nail-to-core body temperatures greater or less than a certain value, detecting which digits show normal versus abnormal nail and/or pad temperatures, and by other algorithms. By determining which digits show normal or abnormal temperature measurements, various neurological, circulatory, traumatic, or infectious processes may also be detected by the methods of this invention.
[0040] A method comprising a step of providing a digital computing device 112 in communication with the disease detection device 200 via Board Connector J1 is herein described. This digital computing device executes programmable instructions to execute the following steps: The computing device is configured to interact with users to provide instruction to aid during the test. At another step, the computing device instructs the subject via visual or audible means 114 to enter a vasoconstricted state by resting while lightly clothed in an area of ambient temperature at least 20 F. (11.1 C.) below the nominal body temperature of the user for about 15 minutes as timed by the computer program. During this time the program reminds the subject that the digits should be unclasped in free air and not touching anything. This temperature equilibration period could be shortened or waived by invoking a command to the computing device in case of repeat testing or an already vasoconstricted subject.
[0041] At another step, the computing device 112 instructs the subject by visual or audible means 114 to insert one digit at a time into the device measurement area. For example, the computing device might display visually or by voice command Insert the left ring finger. The digit sensing circuit 500, shown in
[0042] The computing device then registers that the requested digit cannot be tested and instructs the subject to insert the next digit into the device 200. At another step, after measuring as many of a subject's digits temperatures as possible, the computing device examines the collected data and with the use of experimentally-defined parameters, look-up tables, artificial-intelligence algorithms, and/or other computational techniques, computes and displays the various diagnostic possibilities that could account for the detected thermal pattern. These results can then be printed, saved in memory, and/or transmitted via electronic means as appropriate for the medical case.
[0043]
[0044] In another embodiment shown in
[0045] In the same embodiment of the thermographic device 600 as shown in
[0046] In at least one embodiment, the present invention provides a method for detecting the thermal pattern of the subject utilizing the non-contact thermographic device 600 is disclosed. The attached computing device 612 with a specialized software program first instructs the subject to enter a vasoconstricted state by resting in an area of 68 to 70 F. (20 to 21 C.) ambient temperature while lightly clothed for about 15 minutes as timed by the computer program. During this time the computing device 612 reminds the subject that the hands should be unclasped in free air and not touching anything. This temperature equilibration period could also be shortened or waived by invoking a command to the computing device 612 in the case of repeat testing or an already vasoconstricted subject. Once the cool-down period is over or has been waived, the computing device 612 instructs the subject to insert one hand into the enclosure, where it is radiometrically imaged by the plurality of thermal imagers. Then the computing device 612 instructs the subject to insert the other hand, which is likewise thermally imaged. Once the thermal image data is sent to the computing device, it is then processed for image features and analyzed for thermal patterns of the nails, fingers, and hand compared to the nominal body core temperature. Differential possibilities for the detected thermal patterns are determined by the computing device 612 and the results are displayed, printed, or output to other devices for medical consideration.
[0047] Particular embodiments and features have been described with reference to the drawings. It is to be understood that these descriptions are not limited to any single embodiment or any particular set of features, and that similar embodiments and features may arise or modifications and additions may be made without departing from the scope of these descriptions and the spirit of the appended claims.