JPWO2021063695A5

JPWO2021063695A5 -

Info

Publication number: JPWO2021063695A5
Application number: JP2022520011A
Authority: JP
Publication date: 2023-09-14

Claims

A device for non-invasively measuring an analyte in the blood of a subject, the device comprising:
(a) a unit containing a body part to be examined derived from the subject;
(b) generating terahertz radiation for irradiating the body part to be examined, particularly in the wavelength range of about 0.1 mm to about 5 mm, about 0.12 mm to about 5 mm, or about 0.1 mm to about 1 mm; radiation source,
(c) a unit for detecting radiation originating from said body part to be examined, comprising:
(i) a unit for detecting terahertz radiation reflected from the body part to be examined, wherein the intensity of the reflected terahertz radiation falls within a wavelength range that varies depending on the concentration of the analyte to be measured; A unit installed to detect terahertz radiation,
(ii) A unit for detecting body-specific infrared rays emitted from the body part to be examined, wherein the unit detects infrared rays specific to the body, the unit detecting infrared rays specific to the body, which detects infrared rays specific to the body, which emit infrared rays from about 0.7 μm to about 20 μm, about 1 μm to about 20 μm, about 5 μm to about 15 μm, particularly about 8 μm. installed for separately detecting at least two different wavelengths or wavelength ranges of infrared radiation in the wavelength range of ~12 μm, wherein a first wavelength or wavelength range of infrared radiation specific to the body; The intensity is substantially independent of the concentration of the analyte to be measured, and at a second wavelength or a second wavelength range, the intensity of the body-specific infrared radiation depends on the concentration of the analyte to be measured. the unit is further installed as necessary to non-specifically detect infrared rays specific to the body;
(d)
(i) an element that measures the temperature of the body part to be examined;
(ii) optionally an element for regulating the temperature of the body part to be examined;
(e)
(i) an element that measures the temperature of the detection unit (c);
(ii) an element for adjusting the temperature of the detection unit (c), the element being designed such that the temperature of the detection unit (c) is lower than the temperature of the body part to be examined;
(f) A unit installed for temperature-correcting and evaluating the signal generated from the detection unit (c) and determining the concentration of the analyte based on the evaluated signal, the unit comprising: An apparatus comprising a unit installed to selectively evaluate body-specific infrared rays originating from capillaries in the dermis of the body region, if necessary.

Said radiation source (b) for generating terahertz radiation comprises an antenna, in particular a patch antenna or a dipole antenna, and/or
2. The device according to claim 1, wherein the radiation source (b) for generating terahertz radiation is arranged to emit frequency-modulated or pulse-modulated terahertz radiation.

A focusing lens, such as a spherical lens, an aspherical lens, or a Fresnel lens, is disposed in the radiation path between the radiation source (b) that generates the terahertz radiation and the body part to be examined, and the focusing lens The lens is made of a material that is substantially transparent to terahertz radiation, wherein said focusing lens directs the radiation generated by said terahertz radiation (b) to a predetermined zone of said body part to be examined, in particular to the capillaries. 3. Device according to claim 1 or 2 , preferably arranged for focusing on a zone containing blood vessels .

said unit (c)(i) is arranged for detecting a broadband spectrum in the terahertz range, in particular in the frequency range of about 0.12 mm to about 5 mm (corresponding to 60 GHz to about 2.5 THz), and/ or
said unit (c)(i) is arranged for producing a single or multi-stage amplification, in particular a two-stage amplification, of the terahertz radiation reflected from said body part to be examined; and/or
The unit (c) (i) is installed to detect in combination the terahertz radiation reflected from the body part to be inspected and the terahertz radiation irradiated to the body part to be inspected, 4. The device according to claim 1, wherein the unit (c)(i) is arranged in particular for detecting frequency-modulated or pulse-modulated signals.

5. Device according to any one of claims 1 to 4 , characterized in that the device does not include an external infrared source.

The unit (a) accommodating the body part to be examined comprises an element supporting the body part to be examined which is at least partially thermally insulating with respect to the radiation detection unit (c); transmits terahertz radiation, particularly in the wavelength range from about 0.12 mm to about 5 mm (equivalent to about 60 GHz to about 2.5 THz), or a subrange thereof, and in particular in the wavelength range from about 8 μm to 12 μm, or a subrange thereof. 6. A device according to any one of claims 1 to 5 , comprising a range transmitting.

The unit (a) accommodating the body area to be examined comprises means, such as sensors, for detecting and/or controlling the support position and/or the support pressure of the body part to be examined, in particular about 7. Means for detecting and/or controlling a support pressure in the range 0.5 to 100N, preferably in the range about 1 to 50N, particularly preferably about 20N , are provided. The device described.

The unit (c)(ii) for detecting body-specific infrared radiation comprises at least one first sensor, at least one second sensor and optionally at least one third sensor; In the sensor of No. 1, the intensity of the body-specific infrared rays is substantially independent of the glucose concentration of the analyte to be measured . The second sensor is arranged to detect infrared radiation having a first wavelength or wavelength range in the region of 8 μm to approximately 12 μm, and the second sensor is configured such that the intensity of the body-specific infrared radiation is in accordance with the concentration of the analyte to be measured. detecting infrared radiation having a second wavelength or a second wavelength range in the region of about 0.7 μm to about 20 μm, about 1 μm to about 20 μm, about 5 μm to about 15 μm, in particular about 8 μm to about 12 μm, varying according to The third sensor is installed to refer to infrared rays specific to the body,
The body-specific infrared radiation detecting unit (c)(ii) is configured to detect infrared radiation of different wavelengths or wavelength ranges, the intensity of the body-specific infrared radiation varying depending on the concentration of the analyte to be measured. 8. Device according to any one of claims 1 to 7 , comprising preferably two or more second sensors installed .

Said radiation detection unit (c) is in contact with a thermally conductive support, in particular said terahertz radiation detection unit (c)(i) and said infrared detection unit (c)(ii) having the same 9. The device according to claim 1, wherein the device is in contact with a thermally conductive support.

Any of claims 1 to 9 , wherein a temperature in the detection unit (c) is provided that is at least 5°C, at least 6°C, or at least 7°C and at most 15°C lower than the temperature of the body part to be examined. The device according to item 1.

The device is provided for sequentially detecting terahertz radiation and infrared radiation, in particular first detecting body-specific infrared radiation without irradiating the body part to be examined, and then detecting body-specific infrared radiation without irradiating the body part to be examined. 11. The device according to claim 1, wherein the device irradiates the body part to be treated with terahertz radiation and detects the reflected terahertz radiation.

said unit (f) is provided for temperature-corrected evaluation of the signal on the basis of temperature values measured by said elements (d) and/or (e) and adjusted as necessary; and/or
12. Claims 1 to 11 , characterized in that the unit (f) is provided for the combined evaluation of the signals arising from the terahertz detection unit (c)(i) and the infrared detection unit (c)(ii). The device according to any one of .

13. The device according to claim 1, for noninvasively quantitatively measuring an analyte in the blood of a subject.

A method for non-invasively quantitatively measuring an analyte in the blood of a subject, the method comprising:
(i) irradiating a body part originating from a subject with terahertz radiation, particularly terahertz radiation in a wavelength range of about 0.1 mm to about 5 mm, about 0.12 mm to about 5 mm, or about 0.1 mm to about 1 mm; detecting reflected terahertz radiation by a unit for detecting terahertz radiation originating from the irradiated body region in a wavelength range in which the intensity of the reflected terahertz radiation varies depending on the concentration of the analyte to be measured; ,
(ii) from about 0.7 μm to about 20 μm, from about 1 μm to about 20 μm, from about 5 μm to about 15 μm, or from about 8 μm to about 12 μm, where the intensity of body-specific infrared radiation is not substantially dependent on the concentration of the analyte to be measured; at least one first wavelength or first wavelength range in the wavelength range of about 0.7 μm to about 20 μm, about 1 μm to about 1 μm, where the intensity of the body-specific infrared rays varies depending on the concentration of the analyte to be measured. at least one second wavelength or a second wavelength range in the wavelength range of about 20 μm, about 5 μm to about 15 μm, or about 8 μm to about 12 μm; separately detecting body-specific infrared radiation and optionally non-specifically detecting body-specific infrared radiation from a reference illuminated body surface area, the temperature of the area of the infrared detection unit being a step that is lower than the temperature of the desired body part;
(iii) a step of compositely evaluating the signals detected according to (i) and (ii), taking into account the temperature of the body part to be examined and the temperature in the range of the terahertz radiation unit and the infrared detection unit; and optionally performing selective evaluation of body-specific infrared rays generated from capillaries in the dermis of the body part;
(iv) determining the concentration of the analyte to be measured on the basis of the evaluated signal , the measurement of said analyte arising from a fingertip of the subject, preferably without excitation by an external infrared source; and detecting body-specific infrared radiation .

15. The method of claim 14 , wherein the analyte is selected from alcohol, lactate, protein and urea.