WO1990013092A1 - Procede et appareil d'analyse d'informations recueillies dans des zones symetriques d'un organisme vivant - Google Patents

Procede et appareil d'analyse d'informations recueillies dans des zones symetriques d'un organisme vivant Download PDF

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Publication number
WO1990013092A1
WO1990013092A1 PCT/US1990/002230 US9002230W WO9013092A1 WO 1990013092 A1 WO1990013092 A1 WO 1990013092A1 US 9002230 W US9002230 W US 9002230W WO 9013092 A1 WO9013092 A1 WO 9013092A1
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WIPO (PCT)
Prior art keywords
data
temperature
breast
analysis
predetermined
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PCT/US1990/002230
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English (en)
Inventor
Michael Gautherie
Aziz Yahyai
Jean Deprins
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Bio-Monitor, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
Application filed by Bio-Monitor, Inc. filed Critical Bio-Monitor, Inc.
Publication of WO1990013092A1 publication Critical patent/WO1990013092A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/41—Detecting, measuring or recording for evaluating the immune or lymphatic systems
    • A61B5/411—Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/01—Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue
    • A61B5/015—By temperature mapping of body part
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H15/00—ICT specially adapted for medical reports, e.g. generation or transmission thereof

Definitions

  • This invention relates to method and apparatus for analyzing information gathered from symmetric areas of a living organism and, more particularly, to an innovative analysis technique which provides for early and reliable detection of abnormal bodily conditions.
  • One such method is to gather data generated by the body, such as temperature, electrical activity and the like, and to analyze that information in an effort to detect abnormalities.
  • a detectable electrical potential is generated by the action of the heart and it is common medical practice to monitor such potential levels. Electrodes are fastened to the skin of the patient and the voltages generated are recorded on a continuous roll of graph paper by a galvanometer stylus, which deflects in proportion to the voltage signal. The resultant electrocardiograph must then be analyzed by a trained observer to detect abnormalities, if any, in the action of the heart.
  • electrocardiograms are extremely useful in monitoring heart activity, they generally provide only a "snapshot" of such activity, which snapshot must be analyzed and compared with previous electrocardiograms in order to give an indication of the condition of the heart. Electrocardiograms, however, have the disadvantage of not providing data over an extended period of time, or under ambulatory conditions.
  • the Holter twenty-four hour ECG monitor was developed.
  • This device consists of a plurality of electrodes which are fastened to the skin, and a portable data collection system, which is connected to the electrodes and worn by the patient on a belt, or attached to the patient by other means.
  • the patient wears the device for twenty-four or forty-eight hours, and the data collection system records all heart activity during that interval under ambulatory conditions.
  • the data collection system is subsequently returned to a doctor's office, where the data is used to generate an electrocardiogram for analysis by the doctor.
  • body temperature Another body parameter that is often monitored in an attempt to detect abnormal bodily conditions is body temperature, as it has been known since antiquity that an increase in body temperature often forecasts, or accompanies, disease conditions.
  • body temperature One particular area in which body temperature has been used in an attempt to detect disease is the early detection of breast cancer.
  • Clinical studies have conclusively established that the great majority of malignant mammary tumors act as localized heat sources.
  • the temperature of a breast effected by a malignant tumor remains elevated, while a normal breast fluctuates through a twenty-four hour temperature cycle.
  • the normal twenty-four hour temperature cycle comprises a relatively lower temperature during the day and a higher temperature at night.
  • the temperature difference between a normal breast and that of a breast containing a malignant tumor provides the basis for the diagnosis of breast cancer by known thermographic techniques.
  • U.S. Patent No. 3,960,138 there is provided a method and apparatus for detecting the presence of breast cancer in which the breast receiving cups of a brassiere are each provided with thermally conductive material next to the skin, with a thermistor attached to the thermally conductive material in each cup.
  • the thermistors are connected to the adjacent arms of a Wheatstone bridge. In the absence of a tumor, both breasts remain substantially the same temperature, and the Wheatstone bridge remains balanced. If a tumor is present in one breast, the higher temperature in the diseased breast unbalances the Wheatstone bridge and provides an indication of an existing abnormality.
  • U.S. Patent No. 4,055,166 Another such system is described in U.S. Patent No. 4,055,166.
  • a brassiere which includes a number of skin temperature sensors.
  • the sensors are connected to battery operated integrated circuits, including storage registers, with all such circuits, including the battery, being integral with the brassiere.
  • the breast temperature at predetermined intervals is recorded and the recorded temperature is subsequently printed for examination by an operator.
  • the brassiere is designed to be worn normally while skin temperature monitor ing is performed.
  • This system is specifically designed to collect temperature data over an extended period of time under ambulatory conditions.
  • a scanning array unit consisting of a matrix of sensitive sensing elements such as thermopile devices, which are mounted in close but spaced relation to a body to produce an output signal proportional to the temperature of the body.
  • a reference temperature sensor is provided, whose output is compared with the output of the temperature sensing array. The sensor array unit is aligned with a desired first portion of an individual patient, and the multiplicity of the sensors are read and the data stored. The same sensor array unit is then accurately aligned with a second body portion and similarly read. The stored signals are then processed in a pattern recognition program to directly provide an automated diagnosis based on the temperature data.
  • U.S. Patent No. 4,190,058 An additional temperature monitoring system is described in U.S. Patent No. 4,190,058.
  • a device for the early detection of breast cancer comprising a flexible heat conductive web, preferably in the form of a disc shaped patch, having an adhesive layer on one side thereof, and a peelable layer removably secured thereto by said adhesive layer.
  • the device comprises an array of spaced apart indicators each of which comprise a dye or a pigment in a temperature sensitive substance, which melts at a relatively precise temperature. As many indicators are used as are necessary to cover the desired temperature range.
  • the device is incorporated into the breast receiving cups of a brassiere, mirror image quadrants of the two breasts are scanned, and the device is visually examined to determine the number of indicators which have displayed a change in color, thus apprising the doctor of the existence of potential abnormality in the mammary tissue.
  • Such deficiencies include, for example, the inability to monitor bodily conditions over extended periods of time and under ambulatory conditions, the lack of a rapid and automated analysis of the collected data, the need to provide trained personnel to interpret the data gathered and prepare a report for the patient, and the inability to accurately and consistently detect abnormal conditions which may lead to serious disease. It is apparent that if a system existed for the analysis of information gathered from the human body, which system did not suffer from the foregoing deficiencies, a marked advance in the early detection of certain diseases would be possible.
  • an object of the instant invention to provide method and apparatus to analyze information gathered from a living organism in order to detect body abnormalities.
  • apparatus and methods have been developed for determining abnormalities in a living organism, which abnormalities may be indicative of disease.
  • a data collection device which gathers and records data from symmetric areas of a living organism over a predetermined interval. The recorded data is thereafter transmitted from a first location, to a data analysis center at a second location.
  • the data is analyzed at the analysis center by performing ipsilateral and contralateral comparisons, and a chronobiologic analysis on selected portions of the recorded data.
  • the analysis center automatically generates a patient report, indicative of the absence, or presence, of disease in the living organism, and transmits the report from the analysis center to the first location.
  • quasi-continuous recording of skin temperature under ambulatory, or in-bed conditions is conducted at N symmetrical locations of the human body.
  • reading time can be up to several days with a predetermined measuring frequency.
  • the temperature data gathered is analyzed by performing N/2 contralateral comparisons (opposite and symmetrical body locations), and 2L ipsilateral comparisons (same body location), where L is the number of significant comparisons per body site, with the total number of comparisons M equal to N/2 + 2L.
  • interdependence coefficients and attenuation coefficients are calculated from the temperature data, and a chronobiologic analysis is performed based on the calculated coefficients, which analysis provides information indicative of the absence, or presence, of potential bodily disease.
  • the inventive apparatus and method is utilized for the early detection of breast cancer. Temperature sensors are placed on predetermined areas of the breast, one temperature sensor being located on each breast quadrant and one additional temperature sensor being placed in the nipple/areola area of each breast. Temperature data from the temperature sensors is recorded every five minutes over a twenty-four hour interval under ambulatory conditions and this temperature data is stored in a portable data collection device.
  • the data collection device is lightweight, unobtrusive, and designed to be worn around the waist of a patient.
  • the data collection device is removed from the patient at a doctor's office or similar location, and the recorded temperature data is transmitted over a communications link to a remote data Analysis Center.
  • the temperature data is analyzed at the Analysis Center by performing ipsilateral and contralateral comparisons of the temperature data, along with a chronobiologic analysis of the data.
  • Ipsilateral comparisons consist of comparing the temperature data from predetermined sensors on the same breast, while contralateral comparisons compare the temperatures from predetermined sensors on opposite breasts. It is a feature of the invention that 16 of 20 possible ipsilateral comparisons, and 5 of 25 contralateral comparisons have been found to be significant and non-redundant for analysis purposes.
  • a plurality of regression coefficients are calculated, based on the ipsilateral and contralateral temperature comparisons, which regression coefficients are characterized by deviations in temperature values when compared with the straight regression line that would represent equal temperatures at any test location at any time.
  • a chronobiologic analysis is performed on the recorded temperature data, which chronobiologic analysis concerns the time patterns of temperature of each breast area, with the time patterns of temperature of each of all other breast areas explored.
  • Relative attenuation coefficients are calculated based on the chronobiologic analysis, which coefficients are characterized by the mean degree in amplitude of the temperature fluctuations between predetermined breast areas.
  • a plurality of relative attenuation coefficients are calculated as part of the analysis process.
  • a score and a chronothermodynamic class is assigned to each specific breast depending upon the calculated values of the regression coefficients and the relative attenuation coefficients.
  • the chronothermodynamic class represents, in an index of I- IV, an increasing degree of abnormality.
  • the entire analysis performed at the analysis center is fully automatic, including the printing of an examination report, which is then transmitted to the attending physician.
  • the inventive method and apparatus can be utilized for the chronothermodynamic examination of the upper extremities for the detection of certain vascular diseases.
  • N thermal sensors are utilized and temperatures are recorded for a time interval up to several days, the temperature response being measured in accordance with various stress tests applied to the area of the body being monitored.
  • temperature records are maintained prior to a stress test, during a stress test, and after a stress test, wherein the stress applied to the human body can include temperature extremes, chemical agents, radioactivity, and/or other phenomena.
  • inventive analysis technique is not limited to the evaluation of temperature, but is advantageously capable of analyzing other parameters recorded on the body such as electrical potential, electrical resistance and the like.
  • FIG. 1 illustrates utilization of the inventive method and apparatus for gathering and recording temperature data from the human breast for the detection of breast disease
  • FIG. 2 illustrates use of the inventive method and apparatus to gather and record temperature data from fingertips for the detection of vascular disease
  • FIG. 3 illustrates, in block diagram form, the apparatus of the instant invention
  • FIG. 4 illustrates, in block diagram form, the components of a data collection device useful with the instant invention
  • FIG. 5 illustrates a generalized flow chart of one embodiment of the invention.
  • FIG. 6 illustrates preferred locations of temperature sensors on the left and right breasts
  • FIG. 7 illustrates contralateral comparisons between the left and right breasts
  • FIG. 8 illustrates ipsilateral comparisons from the left breast
  • FIG. 9 illustrates the contralateral and ipsilateral comparisons found to be significant and non-redundant in accordance with the analysis method of the instant invention.
  • FIG. 10 is a flow chart of the analysis method for use with the instant invention when applied to the detection of breast disease
  • FIG. 11A - 11E illustrates temperature data in graph form taken from an actual patient examination
  • FIG. 12 illustrates calculated values of the regression coefficient, attenuation coefficient and chronothermodynamic score for a typical breast examination
  • FIG. 13 represents the chronothermodynamic class for a typical breast examination
  • FIG. 14 illustrates typical temperature data taken from a patient over a 24 hour period
  • FIGS. 15A-B - 18A-B illustrate the manner in which regression coefficients are determined and applied
  • FIGS. 19-20A-B - 21A-B illustrate the manner in which attenuation coefficients are determined and applied
  • FIGS. 22A-D illustrates clinical results obtained through use of the instant invention for healthy breasts, breasts with benign disease, breasts with borderline disease and breasts having cancer;
  • FIG. 23 is a generalized flow chart for the analysis method of the instant invention, when generally applied to vascular studies.
  • FIG. 24 is a more specific description of a vascular embodiment of the instant invention.
  • the instant invention is designed to detect body abnormalities which may lead to disease by recording predetermined body parameters, such as skin temperature, electrical potential, electrical resistance and the like, under non-environmentally controlled/ambulatory and/or in- bed conditions, over variable periods of time ranging from less than one hour to several days, using a portable, multichannel microprocessor based, data acquisition system. After the body parameters are recorded and stored, the data is transferred from the portable multi-channel microprocessor based data acquisition device, to a main frame data processing system, at which a computerized analysis is performed based on the data received. Specific algorithms analyze the data and permit automatic and rapid data analysis, including the delivery of an examination report.
  • predetermined body parameters such as skin temperature, electrical potential, electrical resistance and the like
  • Exemplary applications of the invention may include the chronothermodynamic examination of the breast for the detection of breast cancer, and the chronothermodynamic examination of the upper extremities for the detection of various vascular diseases such as Raynaud's syndrome of various etiologies, acrosyndromes resulting from the professional use of vibrating tools, carpal tunnel syndromes, algodystrophia and rheumatoid arthritis.
  • various vascular diseases such as Raynaud's syndrome of various etiologies, acrosyndromes resulting from the professional use of vibrating tools, carpal tunnel syndromes, algodystrophia and rheumatoid arthritis.
  • the basic method and apparatus described in conjunction with the instant invention can also be utilized to collect and analyze electrical potential generated by various portions of the body, and/or varying electrical resistance of various body portions.
  • the innovative and novel analysis method described and claimed hereafter is the same, which method is able to reliably and accurately detect abnormalities which may be indicative of disease.
  • temperature sensors are placed at predetermined areas of the breast (described below), and temperature data is collected in a data collection device over an extended period of time.
  • the data collection device is designed to be portable and light weight such that the patient can easily and comfortably wear the device on a belt during data collection.
  • the temperature sensors are also designed to be light weight and are affixed to the breast with special self-adhesive, non-allergenic pads to avoid irritation to the breast tissue.
  • FIG. 2 illustrates a similar arrangement for monitoring the temperature at the finger tips of each hand over a predetermined interval.
  • the amount of blood flow in the fingertip area is often indicative of vascular disease of the upper extremities and the amount of blood flow is directly related to temperature at the fingertips. Accordingly, the arrangement illustrated in FIG. 2 monitors fingertip temperature data over predetermined intervals, which temperature data is stored in a data collection device for subsequent processing and analysis.
  • FIGS. 1 and 2 are exemplary only and are not meant to limit the scope or spirit of the invention.
  • FIG. 3 there is illustrated a preferred embodiment for use of the instant invention. More particularly a plurality of sensors 1 are attached to a living organism and transfer data to a portable data collection device 2 , which data collection device, as described above, may be worn by the patient under ambulatory conditions for an extended period of time. After collection of the data over the predetermined interval, the data which has been stored in data collection device 2 may be transferred to a personal computer 3, which includes keyboard 4 and a modem 5. It is anticipated that personal computer 3 will be located at a doctor's office, where the patient will return after the data has been stored in the data collection device. Personal computer 3 can be a standard personal computer, or alternatively an equivalent device merely capable of storing the data collected by data collection device 2 and, thereafter, transferring that data to an Analysis Center.
  • the operator of the system After storage of the collected data in personal computer 3 , the operator of the system calls the Analysis Center 6, which can be situated at any location which permits a communications link between personal computer 3 and Analysis Center 6. Subsequent to contacting the Analysis Center, the operator of this system will identify the particular patient by name, age, or any other parameters necessary for complete identification of a particular patient and, of course, identify the particular location at which the personal computer is located. After sufficient identification information has been entered into the system, personal computer 3 will transmit to the Analysis Center all of the data that has been collected by the data collection device.
  • the Analysis Center is designed to rapidly analyze the incoming data, and generate a patient report for transmission to the doctor's office. It is anticipated that the time necessary for the doctor to remove the data collection device from a patient, transmit the data to the Analysis Center and receive a written report will possibly be no longer than fifteen to twenty minutes. Alternatively, data communications systems exist which will store the report until voluntary retrieval by the doctor. It is also to be understood that the Analysis Center is fully automated and that no trained personnel are required at the Analysis Center to analyze or examine incoming data, or outgoing reports.
  • the data collection device consists of multiplexer 7, which accepts the incoming data from the sensors, multiplexes that data, and applies the data to amplifier 8.
  • the amplified data is thereafter applied to analog to digital (A/D) converter 9, which converts the analog incoming data into digital data for manipulation and storage.
  • A/D analog to digital
  • Microprocessor 11 is controlled by a stored program, resident in EPROM 12.
  • External clock 10 drives the microprocessor, and also provides timing signals to other portions of the circuit where necessary.
  • the incoming data after being processed by microprocessor 11, is stored in random access memory 13.
  • microprocessor 11 will control the extraction of data from random access memory 13 and transmission of that data to personal computer 3 pursuant to instructions stored in EPROM 12, and via communications port 14.
  • the block diagram configuration for data collection device 2 can be readily understood by one skilled in this art and, thus, no further description will be provided for the functions performed by the data collection device.
  • FIG. 5 there is illustrated a generalized flow chart describing the concept of utilizing a computerized chronothermodynamic analysis for ambulatory data acquisition and computerized data processing of temperature data from a human body, which analysis would be performed at the Analysis Center discussed above.
  • Chronothermodynamic examinations consist essentially of recording skin temperature under non-controlled (ambulatory) or controlled conditions, over variable periods of time ranging from less than one hour to several days, utilizing the portable multichannel microprocessor based data acquisition system shown in FIG. 3.
  • Chronothermodynamic examinations rely on the fact that most diseases involve metabolic and vascular disorders and consequently give rise to significant changes in the chronobiologic behavior of skin temperature in reaction to physiological (internal) and environmental (external) stimuli.
  • the advantages of the chronothermodynamic examination are that it explores function and not structure and is strictly non-invasive, which permits fully automatic and computerized data acquisition and processing, and it can be used under a large variety of conditions such as in-bed, ambulatory or with short or long recording periods.
  • the flow chart illustrated in FIG. 5 represents a generalized description of a clinical chronothermodynamic analysis procedure.
  • ipsilateral comparisons refer to temperature measures taken from the same symmetrical body area
  • contralateral comparisons refer to measurements taken from mirror image areas of the body.
  • the inventive technique anticipates the performance of N/2 contralateral comparisons, and 2L ipsilateral comparisons, where L is defined as the number of significant comparisons per body side.
  • L is defined as the number of significant comparisons per body side.
  • M is equal to N/2 plus 2L.
  • Block 17 Characterization of the data sample occurs at Block 17, which is defined as the temperature series recorded at two locations, which characterization includes either ipsilateral or contralateral comparisons.
  • An interdependence relationship is assessed at Block 19, which evaluates the relationship between the temperatures at the two locations being compared. Thereafter, a system of M equations with N unknown parameters are solved to achieve the calculation of an interdependence coefficient (Blocks 21 and 23).
  • the interdependence coefficient also referred to hereinafter as a regression coefficient, characterizes deviations in temperature values when compared with the straight regression line that would represent equal temperatures at any test location and at any time.
  • a spectral analysis (described below) is performed on the data after choosing significant frequency bands, which analysis is performed for each band of frequency chosen (Block 18). Based on the spectral analysis, an attenuation coefficient ratio is calculated, again based on ipsilateral and contralateral comparisons (Block 20).
  • a second system of M equations with N unknown parameters is solved (Block 22) to calculate an attenuation coefficient (Block 24).
  • the attenuation coefficient characterizes the mean decrease in amplitude of temperature fluctuations.
  • the attenuation and interdependence (regression coefficients) are stored in a statistical data base (Block 25). Thereafter, a preliminary calculation of a chronothermodynamic score is performed for each sensor location (Block 26), which score characterizes the possibility of abnormal bodily conditions potentially indicative of disease. Thereafter, (Block 27), the calculated score is compared with previously stored clinical data to assess correlations between newly calculated coefficients and previously stored coefficients to determine whether the calculated CT score is within statistical bounds based on prior stored data (Block 27). Subsequently, an assessment of the chronothermodynamic class CT (Block 28) is performed, which CT class is indicative of the absence or presence of bodily diseases as described below.
  • Temperature readings are recorded for twenty-four hours continuously under ambulatory conditions. Temperature readings are taken every five minutes, from five specific locations on each breast, i.e. four breast quadrants and the nipple/areola area.
  • the thermal sensors are kept in contact with the skin surface by means of self-adhesive non-aller- genic pads. Temperature readings being obtained in this manner demonstrate fluctuations of breast skin temperature in relation to the metabolic and vascular reactions to multiple stimuli, (physiological, behavioral and environmental) which effect the patient during the recording process.
  • FIG. 6 there is illustrated the location of five sensors on both the left and right breasts.
  • the nipple/areola area is shown in the center of each breast illustration, with one sensor 5 being located in the nipple area, and the remaining four sensors 1-4 being located in the four quadrants of the breast as illustrated.
  • the temperature from each sensor is recorded at five minute intervals for a twenty-four hour period and stored in data collection device 2. Subsequent thereto, the data is transmitted to Analysis Center 6, at which time specific algorithms are implemented to process the data and generate a report indicative of the potential of breast cancer.
  • the thermobiologic analysis performed includes recording the temperature levels of each designated breast area, and comparing that temperature data with the temperatures of each of the other areas examined on the same breast (ipsilateral comparisons), as well as comparing the temperature data with the temperature levels on designated areas of the opposite breast (contralateral comparisons).
  • FIG. 7 illustrates the concept of contralateral comparisons where the temperature at quadrant one on the left breast is compared with temperature readings taken at each of the other quadrants and the nipple area of the contralateral breast.
  • FIG. 8 illustrates the concept of ipsilateral comparisons where the temperature of each quadrant of the breast is compared with the temperature at each other quadrant of the same breast. The ipsilateral comparisons shown in FIG. 8 for the left breast are also performed on the right breast, although not shown in FIG. 8.
  • FIG. 9 illustrates the preferred 5 of 25 contralateral comparisons, and the 16 of 20 ipsilateral comparisons which were found to be significant.
  • the comparisons illustrated in FIG. 9 permit a regression coefficient to be calculated, in accordance with the instant invention, which characterizes the deviation in temperature values when compared with the straight regression line that would represent equal temperatures at any test location, at any particular period in time.
  • the larger the regression coefficient the more the thermal levels of the two comparison breast areas could be expected to differ.
  • the regression coefficient in the areas overlying the pathological process have been found to be significantly higher when compared with those of the other ipsilateral and contralateral areas.
  • a total of 21 regression coefficients are developed, four for each breast quadrant and five for the nipple/areola area. The manner in which the regression coefficients are calculated will be described below.
  • the instant invention In addition to calculating a regression coefficient dependent upon the ipsilateral and contralateral temperature comparisons, the instant invention also performs a chronobiologic analysis which concerns the time patterns of temperature of each breast area with the time patterns of temperature of all the other breast areas explored. Such comparisons generally reveal a desynchronization of a variable degree, i.e., over time the temperature fluctuations at one particular area of the breast will exhibit a somewhat different frequency variation then the temperature fluctuations of an adjacent or contralateral area of the breast. Accordingly, in order to analyze this chronobiologic data, a cross-spectral type of analysis of the time series of temperature is used to determine the characteristics of the distribution of the amplitude of the thermal fluctuations by frequency.
  • the attenuation coefficient in an area overlying a lesion is high, compared with those of other ipsilateral and contralateral areas.
  • a total of 60 relative attenuation coefficients (10 breast areas multiplied by 6 frequency ranges) are calculated as described below.
  • a chronothermodynamic score is assigned to each specific breast area depending upon the value of the 21 regression coefficients, and the 60 relative attenuation coefficients. Thereafter, a chronothermodynamic class (CT class) is determined where this classification is derived from an expert system type of analysis based on correlations between the regression and attenuation coefficients, and the relative findings for physical, monographic, echographic, and pathological studies.
  • CT class represents, from an index from of I-V, an increasing degree of abnormality.
  • a report is prepared for the physician, which report is transmitted to the physician's office in the manner described above. The report, a sample of which is discussed below, indicates the score and CT class for each of the five breast areas explored on each breast.
  • FIG. 10 there is shown a data processing flow chart which describes in block diagram form the chronothermodynamic assessment of breast health that occurs at the Analysis Center with respect to the analysis of temperature data for the early detection of breast cancer.
  • the analysis described in FIG. 10 is performed each time data is received for a particular patient. More particularly, referring to FIG. 10, temperature records over a twenty-four hour period, with temperature sampling every five minutes, are received at the Analysis Center, illustrated by the Data Acquisition portion of the flow chart (Block 29). That data is then analyzed, as described above, wherein 5 contralateral comparisons, and 16 ipsilateral comparisons are performed. (Block 30).
  • the first process that is performed is characterization of the data sample (Block 31), wherein the temperature series recorded at two designated breast locations is compared. Thereafter, a calculation of the regression curve (Block 32) is made in a manner to be described below.
  • the next step in the flow chart is solving a system of 21 equations, with 10 unknown parameters, (Block 33), the result of which is a calculation of a regression coefficient for each breast site (Block 34). The precise manner in which this is done is described below.
  • Each regression coefficient is then stored in a statistical data base, (Block 35), which data base is designed to store all previous data that has been collected for the numerous clinical studies performed in accordance with the instant invention.
  • the first step in the calculation of the attenuation coefficient is a spectral analysis for six distinct bands of frequency (Block 36). Thereafter, a calculation of attenuation coefficient ratios occur (Block 37), followed by the solution of a second system of 21 equations, with 10 unknown parameters to calculate the attenuation coefficient for each breast site (Blocks 38 and 39).
  • the attenuation coefficients are also stored in the statistical data base (Block 35).
  • a typical report for a patient may consist of three separate pages.
  • the first page as shown in FIGS. 11A-11E, consists of the chronogramms for each of the five breast areas for the left and right breasts. More particularly, shown in FIGS. 11A-11E, is temperature in degrees centigrade, versus time (over 24 hours) for the areas 1-5 described above. As shown, the temperature is taken every five minutes for a twenty-four hour period to obtain the graphs shown in FIG. 11.
  • That analysis consists of determination of a regression coefficient, an attenuation coefficient and a CT score for each breast area.
  • FIG. 12 is illustrated an example of a patient report, wherein the regression coefficient for the left and right breast, the attenuation coefficient for the left and right breast, and the CT score for the left and right breast is shown.
  • a CT class is assigned for each patient.
  • a CT score of 0-7 is a class I classification
  • a CT score of 7-13 is a class II classification
  • 13-20 is class III
  • 20-34 is class IV
  • 34 and above is class V.
  • Classes I and II are considered to be normal conditions for normal breasts
  • class III is considered to be possibly abnormal and suggestive of disease
  • classes IV and V are considered to be a definite disease condition for the breast.
  • the last page of an exemplary report provided to a physician would consist of what is illustrated in FIG. 13, along with a written recommendation from the Analysis Center to the physician.
  • the upper left quadrant of the right breast has a CT class III classification. This is considered abnormal and, therefore, the recommendation from the analysis center would most likely be that this particular patient should have strict and regular surveillance in order to determine whether a disease condition exists, and/or the breast should be examined with mammographic or other techniques to check precisely for the presence of disease.
  • FIG. 14 there is shown a typical chronothermogram derived from a twenty-four hour monitoring of breast temperature. As illustrated on the x-axis, temperature monitoring commenced at 1400 hours on day one, and continued until 1400 plus hours on day two. The temperature at this particular breast location varied from a low of 31°C to a high of nearly 35°C. Note particularly the rapid increase in breast temperature at the commencement of darkness, where the darkness interval is illustrated by the dark line between 2200 and 0600 hours. During a typical breast examination, a chronothermogram, as illustrated in FIG. 14, will be generated for all ten areas of the breast being monitored. Calculation of the regression and attenuation coefficients will now be described. Refer first to FIG.
  • FIG. 15A wherein, for the sake of explanation, two different breast locations, X and Y, are shown as having constant and equal temperatures of 34oC over a twenty-four hour period. It is understood that location X and Y can be on the same breast, or on different breasts. Similarly, in FIG. 16A, locations X and Y are shown as having identical temperature readings over a twenty-four hour period, which temperature readings, however, vary between temperatures T1 and T2.
  • FIGS. 15B and 16B A straight line regression curve is illustrated in FIGS. 15B and 16B, wherein the temperatures at locations X and Y are plotted versus each other.
  • the plot in FIG. 15B is simply a point, i.e., the temperatures were equal and unvarying through the 24 hour period.
  • the plot in FIG. 16B is a straight line indicating equal temperatures at each location over the twenty-four hour period, which line extends between temperatures Tl and T2.
  • FIG. 17A represents temperature variations over time at locations X and Y, wherein tlie temperatures at each location are not equal to each other at any particular point in time.
  • FIG. 17B is a plot of the temperature at point X, versus the temperature at point Y, and represents the regression curve for the temperature variations illustrated in FIG. 17A. As the temperatures at locations X and Y in FIG. 17A are not equal, the regression curve in FIG. 17B deviates from the dotted 45° straight line plot by a certain angle of deviation.
  • FIG. 18A represents actual temperature readings taken from a patient breast area over a twenty-four hour period. As illustrated, the temperature readings at locations X and Y vary greatly with respect to each other over the twenty- four hour period.
  • the regression curve consists of a cloud of data points, each of which represents a difference in temperature between X and Y at a particular point in the twenty-four hour cycle.
  • the coefficient of the regression curve b2 bn is calculated by inspecting the data sample with respect to a system of coordinates defined by the center of a scattergram and a 45° deviation line.
  • Data is grouped by: (i) defining classes (subsamples of data), using the text of the variance homogeneity; and (ii) by calculating the median for each class. Thereafter, a regression curve is derived, along with relative regression coefficients b2-bn based upon the median values.
  • the regression coefficients are calculated as ⁇ i (cm,cn) wherein cm,cn refers to the temperature sensors being compared, and i refers to the comparison made (1-21).
  • ⁇ characterizes each of the ten breast sites (sensor locations) compared with all other breast sites and is calculated by means of the Huber's robuts estimator.
  • the next step in determining the CT classification for a particular patient is calculation of the attenuation coefficient for each breast site. More particularly, as previously described, the attenuation coefficient is derived from the chronobiologic comparison of the time patterns of temperature of each breast area, with the time patterns of all other areas explored. It is known that the time patterns of temperature for particular breast and other bodily areas exhibit a desynchronization with respect to other bodily areas in terms of responsiveness to external stimuli. For example, referring to FIG. 19, there is represented, by rectangles 1 and 2, the breast tissue surrounding temperature sensors placed at breast locations X and Y. When these breast tissue areas are exposed to external stimuli, such as the temperature variations shown as waveform E in FIG. 19, they exhibit markedly different response characteristics.
  • the temperature at location X will vary, as shown by waveform X in FIG. 19, while the temperature at location Y will exhibit the response shown by waveform Y in FIG. 19.
  • the differences in response are a result of the natural filtering characteristics of breast (or other bodily) tissue and, thus, the temperature at each location X and Y will vary at different frequencies in response to the same external stimuli.
  • FIG. 20A there is shown the temperature response over a twenty-four hour period at two breast locations X1 and Y1.
  • the attenuation coefficient which as recalled is the mean decrease in amplitude of the temperature fluctuations, will be equal to 1 as the amplitude and frequency of both waveforms is the same.
  • X2 and Y2 are varying at the same frequency f2, but are different in amplitude and the instantaneous amplitude of Y2 is approximately one-third the instantaneous amplitude of X2. Accordingly, in this instance, the attenuation coefficient will be equal to one-third.
  • FIGS. 21A and 21B represent further examples of temperature variation at different frequencies at locations X and Y. In these instances, the relationship between X 1 + X 2 and
  • FIG. 21A illustrates that the frequency f 1 and the two chronothermograms (X 1 + X 2 ) and (Y 1 + Y 2 ) have equal attenuation coefficients. In contrast, at frequency f 2 , the attenuation coefficient is higher for the chronothermogram (Y 1 + Y 2 ), compared with the chronothermogram (X 1 + X 2 ).
  • FIG. 21B illustrates that at the frequency f 1 , the chronothermograms X and Y have equal attenuation coefficients. By contrast, at any other frequency different from f 1 , the chronothermogram X is attenuated, i.e. all frequencies but f 1 are filtered.
  • ⁇ j ⁇ j are the coefficients of the A.R.M.A. model (r,r)
  • a weighting factor is applied to the attenuation coefficients in accordance with the following relationship:
  • p1-p6 are the weighting factor which is dependent upon the degree of correlation of the attenuation coefficient with what is expected from an analysis of the statistical data base.
  • the weighting factor would be large with good correlation, and small with poor correlation.
  • the CT score is then determined as follows:
  • g1 and g2 are also a weighting factor determined in the same manner as is the weighting factor p.
  • the chronothermodynamic Class CT represents, from an index of I to V, an increasing degree of abnormality with classes I and II, generally representing none, or very small, chronothermobiologic anomaly, and with Classes III, IV and V representing markedly increasing chronothermobiologic anomalies respectfully.
  • thermal sensors were taped to appropriate regions of the breast and connected to the portable recorder worn on a belt. Patients were advised to perform their usual domestic and professional activities, but to avoid taking a bath or shower. Temperature measurements were recorded every two-five minutes over an approximate twenty-four hour period. Test procedures were well accepted, with an initial refusal or early removal rate of less than one (1%) percent.
  • FIGS. 22 A-D wherein the depicted histograms describe correlations between major diagnostic classifications and chronothermobiologic findings. More particularly, patients in the clinical studies were grouped into four major categories: (a) physically and mammo- graphically healthy breasts; (b) benign conditions, such as dysplasia, tumor or mastopathy; (c) borderline conditions, representing a diseased state with a significant possibility of future cancer; and (d) cancers of variable histology and stage.
  • FIG. 22A illustrates the 117 patients examined, with physical and mammographically healthy breasts.
  • no chronothermodynamic anomalies were found in eighty-six (86%) percent of the patients (CT Class I or II). Accordingly, the rate of false positive findings, i.e., patients with apparently healthy breasts, but classified as CT class III, IV, or V, was 14%.
  • FIG. 22B demonstrates the distribution of 144 patients with benign disease. Thirty (30%) percent of these patient had no chronothermobiologic anomalies, while the majority of seventy (70%) percent had anomalies of variable degrees (Class CT II-V). The 101 patients with positive chronothermodynamic findings had more or less severe glandular or fibrotic dysplasia or solitary and multiple cysts or fibrocystic mastopathy. The 12 patients with marked chronothermodynamic abnormalities (Class CT IV or V), had severe fibrocystic mastopathy with dense and very irregular structure.
  • FIG. 22C The distribution of 18 patients with borderline lesion, i.e. a diseased state with a significant possibility of malignancy is shown in FIG. 22C. This distribution is intermediary with regard to the actual rates of the different CT classes.
  • FIG. 22D shows the distribution of 59 patients with cancer. Ninety (90%) percent of these patients were classified by the instant invention as having marked chronothermobiologic anomalies (Classes CT III, IV or V).
  • the instant invention when used in the application of breast cancer detection, has at least the following advantages: (1) detecting breast cancer earlier and, in particular, in young women with dense breasts, and women with fibrocystic mastopathy; (2) identifying women at high risk of developing breast cancer; and (3) accessing the pre-therapeutic diagnosis of Stage I and II breast cancers based upon the relationship between tumor growth rate and thermovascular changes.
  • the invention can also be utilized to analyze any data extracted from a living organism, when that data is extracted from symmetrical portions of the body, e.g., the hands, elbows, knees, feet, contralateral areas of the face, and so forth. Further, the invention is not limited to analyzing temperature data, but can generally analyze any analog signals extracted from symmetric areas of the body, including by way of example, but not way of limitation, electric voltage, current and resistance generated by the body.
  • FIG. 23 illustrates a generalized data processing flow chart application to clinical chronothermodynamic studies, which studies include a dynamic stress test, utilizing either a physical or pharmacological agent. It is to be noted that previous descriptions of the instant invention did not include the use of a stress test.
  • the temperature records are analyzed during three distinct phases; prior to, during and after a stress test (Blocks 44-47).
  • the stress imposed can include a variety of phenomena including noise , microwave radiation, shock, heat , cold and so forth.
  • a spectral analysis is performed in the same manner as was described previously with respect to FIG. 5. If the chronothermograms present contain significant frequencies (Block 48) the data processing continues in accordance with the flow chart set forth in FIG. 5 (Block 51).
  • the parameters are stored in a statistical data base (Block 53), calculation of single scores for each sensor location is accomplished (Block 54), an assessment of the correlations between parameter/scores and clinical data is performed (Block 55), and a chronothermodynamic class is calculated (Block 56).
  • a chronothermodynamic class is calculated (Block 56).
  • an evaluation of characteristic parameters is performed for each phase of each chronothermogram at Block 49. This same evaluation is conducted during the stress test and after the stress test.
  • An assessment of the scattering and/or synchronization is performed at Block 52 where a comparative analysis based upon contralateral and/or ipsilateral comparisons is conducted. Thereafter, the information is evaluated, as previously described above, in accordance with the remaining steps of the flow chart in FIG. 23.
  • FIG. 24 is a more specific chronothermodynamic assessment of neurovascular conditions of the upper extremities, utilizing a cold stress test. It is to be understood that the flow chart set forth in FIG. 24 is a more specific description of the generalized chronothermodynamic study just described with respect to FIG. 23.
  • FIG. 24 there is described a chronothermodynamic assessment of vascular conditions of the hands and fingers, wherein quasi-continuous recording of skin temperature is performed for each fingertip under ambulatory or in- bed conditions.
  • Ten thermal sensors are utilized, five sensors being placed at symmetrical locations on each hand.
  • a recording time of 45-60 minutes is utilized, with a sampling period of six seconds.
  • a stress test which includes emersion of both hands in cold water at 15°C is utilized (Block 57).
  • the chronothermograms are then analyzed in three distinct phases; prior to, during and after the stress test (Block 58).
  • temperatures Prior to the stress test, temperatures are recorded for 10-15 minutes (Block 59), during the stress test cooling time is limited to three minutes (Block 60), and after the stress test, recording time is set at 30-45 minutes (Block 61).
  • the data is then evaluated to determine the characteristics parameters for each category taking into account initial temperature, rewarming delay, rewarming rate, interval recovering rate, and final recovering rate (Block 62) . Thereafter, a scattering assessment is performed utilizing a comparative analysis based upon ipsilateral and contralateral comparisons (Block 63). Subsequent thereto, the data is then evaluated in Blocks 64-67 in the same manner as has been described above.
  • the instant invention is directed to the collection of data from symmetrical areas of a living organism over predetermined intervals, preferably through use of a portable and lightweight data collection device.
  • the collected data is then stored and transmitted to an Analysis Center, where ipsilateral and contralateral comparisons of data gathered from the symmetrical areas is performed.
  • a chronobiologic analysis of time patterns in the data is accomplished for each test location.
  • the combination of the ipsilateral and contralateral comparisons, and the chronobiologic analysis advantageously permits accurate and reliable detection of bodily abnormalities that could indicate bodily disease.

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Abstract

Un procédé et un appareil permettant de détecter des anomalies dans un organisme vivant qui peuvent indiquer des maladies, par le prélèvement de données dans des zones symétriques du corps. Dans un premier mode de réalisation, des données sur la température sont recueillies dans des zones symétriques du sein (figure 1) et enregistrées pendant une période de 24 heures. Les données sur la température sont transmises à un centre d'analyse de données à distance (6), qui effectue des comparaisons ipsilatérales et contralatérales de données sélectionnées sur la température, ainsi qu'une analyse chronobiologique des données sur la température. Ce procédé et cet appareil permettent de prévoir la possibilité d'états pathologiques du corps humain.
PCT/US1990/002230 1989-04-25 1990-04-20 Procede et appareil d'analyse d'informations recueillies dans des zones symetriques d'un organisme vivant WO1990013092A1 (fr)

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Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE4301524A1 (de) * 1993-01-21 1994-07-28 Jostra Medizintechnik Medizinisches Aggregat oder Gerät für Operationssäle, insbesondere Herz-Lungen-Maschine
EP0846296A1 (fr) * 1995-03-31 1998-06-10 Richard I. Levin Systeme et method d'etablissement de rapport de controle de l'etat de sante des coronaires
GB2342446A (en) * 1998-09-30 2000-04-12 David Ernest Young An improved system for thermometry based breast cancer risk assessment
WO2008015607A1 (fr) * 2006-08-02 2008-02-07 Koninklijke Philips Electronics N.V. Dispositif destiné à assister une prise de décision concernant un traitement médical et/ou à surveiller l'état d'un patient
WO2009142853A1 (fr) * 2008-05-22 2009-11-26 The Curators Of The University Of Missouri Procédé et système de détection optique non invasif du glucose sanguin utilisant l’analyse de données spectrales
US7961304B2 (en) 2007-09-13 2011-06-14 The Curators Of The University Of Missouri Optical device components
US8552359B2 (en) 2009-04-01 2013-10-08 The Curators of the Univesity of Missouri Optical spectroscopy device for non-invasive blood glucose detection and associated method of use
US10542919B2 (en) 2008-03-25 2020-01-28 St. Louis Medical Devices, Inc. Method and system for non-invasive blood glucose detection utilizing spectral data of one or more components other than glucose
CN110786835A (zh) * 2018-08-02 2020-02-14 思凯迪亚数据服务(Cds)有限公司 用于组织评估的***和方法

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3960138A (en) * 1975-01-06 1976-06-01 The United States Of America As Represented By The United States Energy Research And Development Administration Differential temperature integrating diagnostic method and apparatus
US4055166A (en) * 1975-07-09 1977-10-25 Hugh Walter Simpson Apparatus for making surface temperature measurements on the human body
US4121574A (en) * 1977-04-11 1978-10-24 Medicgraph Systems, Inc. Method and apparatus for measuring and recording vital signs of a patient
US4310003A (en) * 1978-02-06 1982-01-12 Schlager Kenneth J Thermographic method of physical examination of patients
US4428382A (en) * 1980-09-03 1984-01-31 Gst Laboratories, Inc. Method for identifying the presence of abnormal tissue
US4572197A (en) * 1982-07-01 1986-02-25 The General Hospital Corporation Body hugging instrumentation vest having radioactive emission detection for ejection fraction
US4754401A (en) * 1986-05-05 1988-06-28 Spacelabs, Inc. System for servicing a removable RAM package for an ambulatory medical monitor

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3960138A (en) * 1975-01-06 1976-06-01 The United States Of America As Represented By The United States Energy Research And Development Administration Differential temperature integrating diagnostic method and apparatus
US4055166A (en) * 1975-07-09 1977-10-25 Hugh Walter Simpson Apparatus for making surface temperature measurements on the human body
US4121574A (en) * 1977-04-11 1978-10-24 Medicgraph Systems, Inc. Method and apparatus for measuring and recording vital signs of a patient
US4310003A (en) * 1978-02-06 1982-01-12 Schlager Kenneth J Thermographic method of physical examination of patients
US4428382A (en) * 1980-09-03 1984-01-31 Gst Laboratories, Inc. Method for identifying the presence of abnormal tissue
US4572197A (en) * 1982-07-01 1986-02-25 The General Hospital Corporation Body hugging instrumentation vest having radioactive emission detection for ejection fraction
US4754401A (en) * 1986-05-05 1988-06-28 Spacelabs, Inc. System for servicing a removable RAM package for an ambulatory medical monitor

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
BEHAVIOUR RESEARCH METHODS & INSTRUMENTATION, Vol. 13(5), October 1981, DABBS et al.: "Differential thermometer for studying cerebral asymmetry", pages 643-646. *

Cited By (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE4301524A1 (de) * 1993-01-21 1994-07-28 Jostra Medizintechnik Medizinisches Aggregat oder Gerät für Operationssäle, insbesondere Herz-Lungen-Maschine
EP0846296A1 (fr) * 1995-03-31 1998-06-10 Richard I. Levin Systeme et method d'etablissement de rapport de controle de l'etat de sante des coronaires
EP0846296A4 (fr) * 1995-03-31 1998-06-17
GB2342446A (en) * 1998-09-30 2000-04-12 David Ernest Young An improved system for thermometry based breast cancer risk assessment
GB2342446B (en) * 1998-09-30 2003-05-07 David Ernest Young An improved system for thermometry-based breast cancer risk assessment
WO2008015607A1 (fr) * 2006-08-02 2008-02-07 Koninklijke Philips Electronics N.V. Dispositif destiné à assister une prise de décision concernant un traitement médical et/ou à surveiller l'état d'un patient
US7961304B2 (en) 2007-09-13 2011-06-14 The Curators Of The University Of Missouri Optical device components
US11147482B2 (en) 2008-03-25 2021-10-19 St. Louis Medical Devices, Inc. Method and system for non-invasive blood glucose measurement using signal change of the non-glucose components induced by the presence of glucose
US10542919B2 (en) 2008-03-25 2020-01-28 St. Louis Medical Devices, Inc. Method and system for non-invasive blood glucose detection utilizing spectral data of one or more components other than glucose
US9629576B2 (en) 2008-05-22 2017-04-25 St. Louis Medical Devices, Inc. Method and system for non-invasive optical blood glucose detection utilizing spectral data analysis
US10080515B2 (en) 2008-05-22 2018-09-25 St. Louis Medical Devices, Inc. Method and system for non-invasive optical blood glucose detection utilizing spectral data analysis
US9579049B2 (en) 2008-05-22 2017-02-28 St. Louis Medical Devices, Inc. Method and system for non-invasive optical blood glucose detection utilizing spectral data analysis
CN102973278B (zh) * 2008-05-22 2016-04-13 密苏里大学董事会 用光谱数据分析进行无创的光学血糖检测的方法和***
US9788764B2 (en) 2008-05-22 2017-10-17 St. Louis Medical Devices, Inc. Method and system for non-invasive optical blood glucose detection utilizing spectral data analysis
US9814415B2 (en) 2008-05-22 2017-11-14 St. Louis Medical Devices, Inc. Method and system for non-invasive optical blood glucose detection utilizing spectral data analysis
US9877670B2 (en) 2008-05-22 2018-01-30 St. Louis Medical Devices, Inc. Method and system for non-invasive optical blood glucose detection utilizing spectral data analysis
US9566024B2 (en) 2008-05-22 2017-02-14 St. Louis Medical Devices, Inc. Method and system for non-invasive optical blood glucose detection utilizing spectral data analysis
WO2009142853A1 (fr) * 2008-05-22 2009-11-26 The Curators Of The University Of Missouri Procédé et système de détection optique non invasif du glucose sanguin utilisant l’analyse de données spectrales
US11076781B2 (en) 2008-05-22 2021-08-03 St. Louis Medical Devices, Inc. Method and system for non-invasive optical blood glucose detection utilizing spectral data analysis
US10959650B2 (en) 2008-05-22 2021-03-30 St. Louis Medical Devices, Inc. Method and system for non-invasive optical blood glucose detection utilizing spectral data analysis
US10973442B2 (en) 2008-05-22 2021-04-13 St. Louis Medical Devices, Inc. Method and system for non-invasive optical blood glucose detection utilizing spectral data analysis
US8552359B2 (en) 2009-04-01 2013-10-08 The Curators of the Univesity of Missouri Optical spectroscopy device for non-invasive blood glucose detection and associated method of use
CN110786835A (zh) * 2018-08-02 2020-02-14 思凯迪亚数据服务(Cds)有限公司 用于组织评估的***和方法
CN110786835B (zh) * 2018-08-02 2023-09-19 智佳蝶(杭州)健康科技有限公司 用于组织评估的***和方法

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