Device for non-invasive measurement of blood sugar level
원문보기
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
A61B-005/1455
A61B-005/145
A61B-005/00
출원번호
15764016
(2015-10-05)
등록번호
10278622
(2019-05-07)
국제출원번호
PCT/IB2015/001788
(2015-10-05)
국제공개번호
WO2017/060746
(2017-04-13)
발명자
/ 주소
Arko, Zoran
Tofant, Tadej
출원인 / 주소
DIA-VIT LTD.
대리인 / 주소
The Watson IP Group, PLC
인용정보
피인용 횟수 :
0인용 특허 :
0
초록▼
The object of the invention is a device that allows measuring blood sugar levels in mammals—primarily humans—by measuring the refraction of electromagnetic radiation from the skin or body tissue, without the need for invasive sampling, such as penetrating or pricking the skin. The device uses the bl
The object of the invention is a device that allows measuring blood sugar levels in mammals—primarily humans—by measuring the refraction of electromagnetic radiation from the skin or body tissue, without the need for invasive sampling, such as penetrating or pricking the skin. The device uses the blue light portion of the visible spectrum and near-infrared (IR) radiation as a source of electromagnetic radiation. The device falls within the field of medical diagnostics and is essentially designed to be portable, so that the users can wear it on their wrists, for example. The signals of reflected light/radiation measured by the sensor unit are filtered by the frequency filtering set and mathematically processed in order to Calculate the current blood sugar level. The accuracy of the measurement result of the device is comparable to the results obtained with the standard method of measuring by blood sampling. A method for measuring of blood sugar level using said device is also disclosed.
대표청구항▼
1. A device for non-invasive measurement of blood sugar levels in mammals, preferably humans, by measuring electromagnetic radiation that is reflected from the skin and/or tissue, characterised in that the device includes: a blue light source with a wavelength of 430 nm to 480 nm;an infrared (IR) ra
1. A device for non-invasive measurement of blood sugar levels in mammals, preferably humans, by measuring electromagnetic radiation that is reflected from the skin and/or tissue, characterised in that the device includes: a blue light source with a wavelength of 430 nm to 480 nm;an infrared (IR) radiation source with a wavelength of 700 nm to 3000 nm;a sensor unit for measuring a blue light and an IR radiation reflected from the skin and/or tissue and converting them into a change in resistance or electrical current or voltage;a frequency filtering set for signal filtering, comprising one or more analog and/or digital frequency filters with which all frequencies of the signal are filtered out except for a determined frequency band around and including a frequency of the blue light pulsation FB, when measuring blue light, and a determined frequency band around and including an IR radiation pulsation frequency FIR, when measuring IR radiation; anda processing unit with a memory for the program and a memory for storage and processing of measurement results that: a) controls the excitation of the blue light source with the pulsation frequency FB and the excitation time interval TB, where FB is selected from the range between 100 kHz and 300 kHz, and TB is selected from the range between 1 second and 10 seconds;b) controls the excitation of the IR radiation source with the pulsation frequency FIR and the excitation time interval TIR, where FIR is selected from the range between 1 kHz and 50 kHz, and TIR is selected from the range between 1 second and 10 seconds;c) controls the filtering of the frequency filtering set;d) from individual measuring intervals for the blue light and separately for the IR radiation captures searched signal values from the filtered signal, ande) from the searched signal values calculates the blood sugar level using a preset mathematical algorithm. 2. The device according to claim 1, characterized in that the blue light source is a blue LED with a wavelength of 460 nm, pulsating with the frequency FB equal to 200 kHz in the excitation time interval TB of 7 seconds, the source of IR radiation is an IR LED with a wavelength of 940 nm, pulsating with the frequency FIR of 10 kHz in the excitation time interval TIR of 7 s, the sensor unit is a photodiode with a range of detected wavelengths from 300 to 1100 nm, and the blue LED and IR LED are mounted on the device as close as possible to the photodiode. 3. The device according to claim 1, characterised in that the frequency filtering set includes “high pass” frequency filters, “band pass” frequency filters, and the ADC converter which has at least 20 bit resolution for blue light and at least 10 bit resolution for IR radiation. 4. The device according to claim 1, characterised in that the frequency filtering set additionally includes a transimpedance amplifier with an amplifying factor of 1:1000 when measuring blue light reflection and a transimpedance amplifier with an amplifying factor of 1:1 when measuring IR radiation reflection. 5. The device according to claim 1, characterised in that the device additionally includes a display for displaying the level of blood sugar, a communications circuit that enables programming and controlling the device and/or sending the measured and calculated values of blood sugar level to a computer or other device, and at least one button for turning the device on and off and controlling display settings. 6. The device according to claim 1, characterised in that the device includes a strap for fastening the device to the measurement spot on the body, preferably on the wrist, and a battery or other power source. 7. The device according to claim 1, characterised in that the searched signal values in the filtered signal are absolute maximum voltage values and absolute minimum voltage values at each measuring interval, namely UBmax and UBmin when measuring blue light reflection, and UIRmax and UIRmin when measuring IR radiation reflection. 8. A method for measuring a blood sugar level that includes the following steps: attaching the device of claim 1 to the measuring location on the body, so that the blue light source, the IR radiation source, and the sensor unit are in close contact with the skin and/or tissue of the measuring location;measuring with the blue light source, which includes: a) exciting the blue light source, so that it is pulsating with the frequency FB in the time interval TB,b) detecting the reflected light with the sensor unit and converting the detected light into electrical signal,c) filtering the signal from the sensor unit with the frequency filtering set that filters out the signal of all frequencies except for the specified frequency band around and including the frequency of blue light pulsation FB,d) capturing searched signal values from the filtered signal when measuring the blue light reflection;measuring with the IR radiation source, which includes: a) exciting the IR radiation source, so that it is pulsating with the frequency FIR in the time interval TIR,b) detecting the reflected IR radiation with the sensor unit and converting the detected IR radiation into electrical signal,c) filtering the signal from the sensor unit with the frequency filtering set that filters out the signal of all frequencies except for the specified frequency band around and including the frequency of blue light pulsation FIR,d) capturing searched signal values from the filtered signal when measuring the IR radiation reflection;calculating the value of blood sugar level with a predefined mathematical algorithm using the searched signal values of blue light reflection measurements and the searched signal values of the IR radiation reflection measurements,wherein measuring with the blue light source and measuring with the IR radiation source are mutually independent, so the order is arbitrary. 9. The method according to claim 8, characterised in that the searched signal values in the filtered signal are absolute maximum voltage values and absolute minimum voltage values at each measuring interval, namely UBmax and UBmin when measuring blue light reflection, and UIRmax and UIRmin when measuring IR radiation reflection. 10. The method according to claim 8, characterised in that the signal filtration when measuring with the blue light source includes: a. signal amplification with a transimpedance amplifier with an amplifying factor of 1000, and at the same time an electrical signal, that is electrical current, is converted into voltage,b. followed by signal filtration with “band pass” filtration, which filters out all the frequency components from the signal, with the exception of frequency component FB, equal to 200 kHz and the surrounding band ±10%, andc. conversion of the signal to digital format by the ADC converter, which has at least 20 bit resolution. 11. The method according to claim 8, characterised in that the signal filtration when measuring with the IR radiation source includes: a. directing the signal from the sensor unit to the transimpedance amplifier with an amplifying factor of 1:1, where the electrical signal, that is electrical current, is converted into voltage,b. signal filtering with the “high pass” frequency filter, which filters out all the frequencies under 20 kHz from the signal,c. deducting an ambient component from the thus filtered signal,d. conversion of the signal to digital format by the ADC converter, which has at least 10 bit resolution, ande. frequency filtration with “band pass” filtration, which filters out all the frequency components from the signal, with the exception of frequency component FIR, equal to 10 kHz, and the surrounding band ±10%. 12. The method according to claim 11, characterised in that the ambient component measuring is performed before measuring the IR signal or after measuring the IR signal, wherein at least half a second must pass between the last excitation of any light/radiation source and measuring the ambient component and during measuring the IR radiation source and the blue light source must not be excited; thus obtained signal is amplified through the transimpedance amplifier and converted from current to voltage with the same factor as the IR signal measured. 13. The method according to claim 9, characterised in that the value of blood sugar level is calculated by the following formula: AG=K1×X1X2-K2 where X1=(UBmax-UBmin)×UIRmin(UIRmax-UIRmin)×UBmin and X2=ln(UBmaxUBmin)ln(UIRmaxUIRmin). 14. The method according to claim 9, characterised in that prior to starting the measurement, a test protocol is carried out, verifying that the device is properly mounted on the measurement location on the body, in which either the blue light source with the pulsation frequency FB or the IR radiation source with the pulsation frequency FIR is excited, the sensor unit detects blue light or IR radiation reflected from the skin and/or tissue, converts it to a signal that is filtered through the frequency filtering set; the processor unit compares the filtered signal with a preset value and if the signal obtained is greater than the preset value, it means that the reflection is strong enough, therefore, the device is properly attached to the body part. 15. The method according to claim 9, characterised in that the measurement method is repeated several times in a row, wherein so obtained successful measurement results are statistically processed and provided to the user as the average value of all measurements or as value±error.
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