KR102348196B1 - Optical Analyte Monitering Method And System With Subcutaneous Implantation Device - Google Patents

Abstract

An optical analyte monitoring system using a subcutaneous insertion device of the present invention includes: a subcutaneous insertion device including a first light source for emitting light for measuring optical characteristics of the analyte, a power generation unit for generating electricity for operating the first light source, and a first control unit controlling a first communication unit for transmitting a signal for controlling the operation of the first light source, the power generation unit, and a first communication unit; and an outer skin device including a second communication unit for communicating with the first communication unit, an energy transmitting unit for transmitting energy capable of generating electricity from the power generation unit, and a second control unit for controlling the second communication unit and the energy transmitting unit. The subcutaneous insertion device, the external skin device, or a separate device is provided with a first optical sensor for measuring the optical characteristics of the light from the first light source passing through the analyte.

Description

Optical Analyte Monitoring Method And System With Subcutaneous Implantation Device

The present invention relates to a method and system for monitoring an optical analyte using a subcutaneous insertion device, and more particularly, by implanting a separate device under the skin and monitoring biometric information to be analyzed by itself or in cooperation with an external device by an optical method It relates to an optical analyte monitoring method and system using a hypodermic insertion device for

Diabetes is increasing due to the aging of the population and westernization of lifestyles in recent years.

Diabetes is known to be caused by the pancreas not making enough insulin or the human body not responding properly to insulin, and chronic hyperglycemia caused by lack of insulin is accompanied by several characteristic metabolic abnormalities. Since insulin is mainly involved in carbohydrate metabolism, diabetes mellitus is a basic problem of abnormal carbohydrate metabolism, but because of this, all nutrient metabolism in the body is affected.

In particular, diabetes mellitus is a disease that requires constant control of blood sugar, and patients suffer from having to prick their finger before and after every meal to collect a small amount of blood to measure blood sugar.

In order to solve this problem, a method for measuring blood sugar for a certain period of time without measuring blood sugar by pricking a needle each time has been developed, and related devices are being marketed.

Commercially available equipment called Continuous Glucose Monitoring System (hereinafter referred to as 'CGMS') is as follows.

Dexcom, USA, where microneedles are immersed into the skin and then measured by a patch. Inc.'s CGMS (refer to Korean Patent Application Laid-Open No. 10-2020-0067124) has a microneedle replacement cycle of about 7 days, and in the case of CGMS of ABBOTT DIABETES CARE Inc., such as those disclosed in US Patent No. 7,951,080, 14 days Each patch must be replaced.

CGMS of Senseonic Inc. disclosed in US Patent No. 9,814,389 is to insert a capsule coated with a material exhibiting fluorescence properties by reacting with glucose into the human body to receive measurement values by an external transmitter. In the case of US Patent No. 9,814,389, although NFC is used to communicate with the capsule in the body, there is a problem in that it is difficult to use semi-permanently due to the biochemical properties of the substance that reacts with glucose. Capsules should be replaced approximately every 90 days.

The development of semi-permanently usable CGMS is being requested due to the inconvenience of wearing the CGMSs as described above and the need for periodic replacement.

Currently, semi-permanent CGMS applies an optical method, an electrical method, a method for measuring substances in the respiratory system, and a method for measuring blood sugar in a tissue fluid by inserting a sensor into the tissue. (Wonsil Ahn and Jin-Tae Kim, "Blood Glucose Measurement Principle of Non-invasive Blood Glucose Meter: Focused on the Detection Method of Blood Glucose", Journal of Biomedical Research 33: 114-127, 2012)

Among these, optical methods are infrared spectroscopy, Raman spectroscopy, optical coherence tomography (OCT), polarization, fluorescence, and occlusion spectroscopy. , photo-acoustic spectroscopy, etc. are applied.

The optical measurement method using light to measure blood glucose concentration is completely non-invasive and has no stimulation, so it can be said to be a true blood-less blood glucose meter. Various R&D is being carried out.

Among the optical methods, the spectroscopic method is a method of measuring the presence or concentration of a specific material by measuring how it reacts with light.

When light passes through matter, it is reflected, scattered, refracted, absorbed, and some is transmitted. In some cases, when light strikes a substance, the substance emits specific energy. Depending on the wavelength of light, the degree of absorption, transmission, and divergence can be drawn, and this is called a spectrum.

The spectroscopic technique of measuring and analyzing the absorption or radiation of light by a substance by dividing it into a spectrum using a spectrometer or a spectrophotometer is used in various medical fields, such as measurement of blood oxygen saturation.

In order to measure blood sugar using light, light is first emitted to send light to blood or tissue containing the sugar to be measured, and the amount of light reflected/scattered/absorbed/transmitted as it passes through the tissue is measured. (Jyoti Yadav, Asha Rani, Vijander Singh and Bhaskar Mohan Murari, "Near-infrared LED based Non-invasive Blood Glucose Sensor", 2014 International Conference on Signal Processing and Integrated Networks, 591-594, 2014)

To apply this spectroscopic measurement method, a light source capable of emitting light of an arbitrary wavelength is provided, and an optical sensor that passes through blood or tissue and detects the amount of reflected/scattered/absorbed/transmitted light or specific energy emitted should be provided

In general, the spectroscopic measurement method is a form of analyzing that the amount of reflection/scattering/absorption/transmission of light passing through the skin varies depending on the optical characteristics of each material constituting the human body by bringing the light source and the optical sensor into contact with the skin. is done

However, there are various difficulties in measuring the amount of an analyte in a living body using light. This is because the layers constituting the skin itself cause light reflection and refraction, and the roughness of the skin can also affect the light path. For example, the stratum corneum and the cortex absorb a significant amount of light and impede light transmission. In addition, the presence of various analytes in the human body also makes measurement difficult.

The absorption spectrum of light is analyzed the same as measuring the transmission spectrum of unabsorbed light, and materials have their own light absorption transmission spectrum (Light Absorption Transmission Spectrum). can

The components or substances in the human body that must be maintained in a certain amount and are deficient or above an appropriate level in the human body are glucose related to diabetes, Glycated hemoglobin, which indicates the long-term trend of diabetes, and glucose There are final glycation products, which are substances combined with oxygen, red blood cells or hemoglobin that supplies oxygen, oxygen saturation concentration of red blood cells or hemoglobin, blood cholesterol levels, and metabolites that cause jaundice, such as bilirubin and lactic acid. These constituents or substances can be optically measured for their properties.

In addition, fat and protein, which are basic substances constituting the human body, also exhibit light absorption at specific wavelengths.

Each material has its own light absorption spectrum according to the wavelength of light, and the amount of each material can be calculated using this.

For example, while glucose (glucose) is used as an energy source for the human body, an increase in blood concentration causes diabetes, and it is important for diabetic patients to continuously monitor and manage the glucose concentration.

Diabetes is defined by blood glucose concentration (also called 'blood glucose'), and fasting plasma glucose level of 126 mg/dL (7.0 mmol/liter) or higher after fasting for more than 8 hours, or 75 g oral glucose tolerance test for 2 hours Diabetes is defined as diabetes if the plasma glucose level is 200 mg/dL (11.1 mmol/liter) or higher, or if the blood glucose level is 200 mg/dL or higher at any time of the day regardless of meals along with symptoms of hyperglycemia.

Therefore, it is important to measure and manage the blood glucose concentration to be below this reference value.

When glucose is irradiated with light, it shows an absorption peak at wavelengths of light such as 623 nm, 646 nm, 722 nm, 728 nm, 733 nm, 777 nm, 839 nm, 996 nm, 1015 nm, 1024 nm, and is absorbed even in a region with a wavelength longer than 1024 nm It is known that there are wavelengths, and in particular, absorption wavelengths exist between 2100 nm and 2200 nm, and absorption wavelengths in the near-infrared bands of 1688 nm, 2261 nm, and 2326 nm are known to exist.

When the light of a specific wavelength that can be absorbed by glucose is irradiated from the light source and the light that has passed through the body tissue is measured by the optical sensor, if the concentration of glucose increases, the intensity of the light of a specific wavelength input to the optical sensor decreases. do.

In addition, when there are several absorption wavelengths of an analyte such as glucose, the concentration can be measured more precisely by combining them.

Diabetes is sometimes diagnosed by measuring Glycated Hemoglobin (HbA1c) together with the blood concentration of glucose, which is measured as a standard for diabetes.

Glycated hemoglobin is a combination of hemoglobin (hemoglobin) molecules in red blood cells that carry oxygen and glucose in the blood. Since red blood cells are replaced with new red blood cells after about 120 days, glycated hemoglobin usually represents a long-term blood glucose level for 2-3 months.

If the glycated hemoglobin exceeds 6.5%, diabetes is suspected, and the glycated hemoglobin level is related to diabetic complications such as nephropathy and retinopathy in diabetic patients.

It is known that glycated hemoglobin strongly absorbs light at wavelengths of 412 nm, 541 nm, and 577 nm.

On the other hand, the proper amount of red blood cells in the blood also affects health.

The normal level of hemoglobin that makes up red blood cells is 14-17.5 g/dL for adult males and 12.3-15.3 g/dL for adult females. It is known to occur up to

There are 4-5 million red blood cells in 1 μl blood, and it is known that about 280 million hemoglobin is contained in one red blood cell, and anemia is diagnosed based on the amount of hemoglobin.

Absorption peaks of hemoglobin appear at wavelengths of 540 nm and 576 nm when the oxygen saturation concentration is 100 mg Hg or more, and absorption wavelengths such as 760 nm, 805 nm, 820 nm, 910 nm, and 1020 nm are known to exist. Therefore, it is possible to measure the blood oxygen concentration using the absorption wavelength of hemoglobin.

It is known that the absorption peaks of blood cholesterol are about 460 nm and 578 nm, and the absorption wavelengths of water as a substance constituting blood are 749 nm, 880 nm, 980 nm, 1211 nm, 1450 nm, 1787 nm, and 1934 nm.

In addition, fat has absorption wavelengths of 770 nm, 920 nm, and 1040 nm, and protein has absorption wavelengths of about 910 nm and 1020 nm.

Lactic acid formed in muscles has absorption wavelengths at about 747 nm, 823 nm, 923 nm, and 1047 nm, and ethanol, an alcohol absorbed through drinking, etc., has absorption wavelengths at about 669 nm, 881 nm, 1050 nm, 1090 nm, and 1274 nm.

In addition to the spectroscopic method of measuring the spectrum to which the absorption wavelength of light is applied as described above, there is also a method of measuring the transmittance of light by measuring a change in scattering due to a difference in refractive index.

For example, as the concentration of glucose increases, the refractive index decreases, and thus the transmittance of light increases. When the change in transmitted light or diffused or reflected light is measured according to the increased transmittance, the glucose concentration can be measured.

In addition, as described above, it is possible to measure various substances or components using a light source and an optical sensor. ***** has been applied for.

As described above, when the light source and the optical sensor are brought into contact with or close to the skin for measurement, there are various causes that may interfere with the measurement, such as skin color or roughness, and there are many difficulties in solving this problem.

It may be desirable to insert a light source and an optical sensor into the human body for measurement, but there is a problem in that it is difficult to continuously supply energy to emit light from the light source or to communicate with an external device.

KR 10-2020-0067124 A1, 2020.06.11, Fig. 2a US 7,951,080 B1, May 31, 2011, Fig. 2 US 9,814,389 B1, November 14, 2017, Fig. 1B KR 10-2191057 B1, 2020.12.15, Fig. 2

Wonsil Ahn and Jin-Tae Kim, "Blood Glucose Measurement Principle of Non-invasive Blood Glucose Meter: Focused on the Detection Method of Blood Glucose", Journal of Biomedical Research 33: 114-127, 2012 Jyoti Yadav, Asha Rani, Vijander Singh and Bhaskar Mohan Murari, "Near-infrared LED based Non-invasive Blood Glucose Sensor", 2014 International Conference on Signal Processing and Integrated Networks, 591-594, 2014

The present invention was devised to solve the problem of the conventional method of measuring the amount of reflected/scattered/absorbed/transmitted light by projecting light into the human body through the skin surface from the outside. By supplying energy, the light emitted from under the skin can be measured under the skin or outside the skin, and it is an optical device that enables continuous monitoring of biometric information by controlling the subcutaneous insertion device under the skin and transmitting and receiving data. An object of the present invention is to provide a method and system for monitoring an analyte.

An optical analyte monitoring method using the subcutaneous insertion device of the present invention,
An optical measuring unit having a first light source and a first photosensor for measuring optical properties of an analyte;
a photovoltaic cell that generates electricity for operating the optical measuring unit;
a first communication unit for transmitting a signal for controlling the optical measurement unit and the measured optical characteristics of the analyte;
implanting a subcutaneous insertion device having a first control unit for controlling the optical measuring unit, the photocell, and the first communication unit under the skin;
a second optical communication unit communicating with the first communication unit;
a second light source emitting light capable of generating electricity in the photovoltaic cell;
providing an external skin device including a second control unit for controlling the second communication unit and the second light source;
generating electricity by the photovoltaic cell by the light emitted by the second light source of the external skin device;
emitting light from the first light source of the electric furnace optical measuring unit, and measuring the optical characteristics of the emitted light passing through the analyte with the first optical sensor;

and transmitting the measured optical properties of the analyte to the second communication unit through the first communication unit.

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Another method for optical analyte monitoring using a subcutaneous insertion device is,
A first light source emitting light for measuring the optical properties of the analyte;
a photovoltaic cell generating electricity for operating the first light source;
implanting a subcutaneous insertion device having a first control unit for controlling the first light source and the photocell under the skin;
a second light source emitting light capable of generating electricity in the photovoltaic cell;
a first photosensor comprising a camera to measure the optical characteristics of the light from the first light source passing through the analyte;
providing an external skin device including a second control unit for controlling the second light source and the first optical sensor;
generating electricity by the photovoltaic cell by the light emitted by the second light source of the external skin device;

It is characterized in that it comprises; emitting the first light source of the optical measuring means with the generated electricity, and measuring the trajectory appearing on the skin by the emitted light with the first optical sensor.

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The optical analyte monitoring system using the subcutaneous insertion device of the present invention is
A first light source emitting light for measuring the optical properties of the analyte;
a photovoltaic cell generating electricity for operating the first light source;
a subcutaneous insertion device having a first control unit for controlling the first light source and the photocell;
a second light source emitting light capable of generating electricity in the photovoltaic cell;
to the external skin device including a second control unit for controlling the second light source; is made,

It is characterized in that a camera for measuring a trajectory appearing on the skin by the light of the first light source is provided in the external skin device or a separate device.

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It is also preferable that the subcutaneous insertion device further includes a storage battery for storing the generated electricity.

It is also preferable that the energy transfer unit of the external skin device is separated as a separate device.

A first communication unit of an optical communication method installed in the subcutaneous insertion device to transmit a signal for controlling the operation of the first light source;

It is also preferable to further include a second communication unit of an optical communication method that is installed on the external skin device to communicate with the first communication unit.

It is also preferable that the external skin device is provided with a third communication unit to transmit the measurement result to a mobile phone, a PC or a server.

Preferably, the second control unit can analyze the trajectory measured by the camera.

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The skin external device may further include a display unit capable of displaying the trajectory of the light received by the camera.

It is preferable that the entire surface of the subcutaneous insertion device is coated with a coating layer formed of one of transparent synthetic resin, silicone rubber, ceramic, or glass.

Preferably, the first light source includes a plurality of light sources each emitting light of different wavelengths.

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According to the present invention, the problem of the conventional method of measuring the amount of reflected/scattered/absorbed/transmitted light by projecting light into the human body through the skin surface can be solved, and energy is supplied to the subcutaneous insertion device inserted under the skin. The light emitted from under the skin can be measured under the skin or outside the skin, and it has the effect of enabling continuous monitoring of biometric information by controlling the subcutaneous insertion device under the skin and transmitting and receiving data. Accordingly, the present invention has an effect that can be used as a semi-permanent CGMS.

1 is a schematic diagram showing an optical analyte monitoring system according to an embodiment of the present invention.
Figure 2 is a view showing the upper and lower surfaces of the subcutaneous insertion device according to an embodiment of the present invention.
3 is a view showing the configuration of the external skin device.
Figure 4 is a diagram showing the operating relationship of the monitoring system according to an embodiment of the present invention.
5 is a view showing another embodiment of the present invention subcutaneous insertion device.
Figure 6 is a view showing another embodiment of the present invention subcutaneous insertion device.
7 is a view showing an embodiment in which the subcutaneous insertion device is separated into two devices.
8 is a diagram showing the operation relationship of the monitoring system according to another embodiment of the present invention.
9 is a view showing a trajectory appearing on the skin surface according to an embodiment of the present invention.
10 is a view showing an embodiment in which a plurality of first light sources of the subcutaneous insertion device emit light at different angles.
11 is a view showing an embodiment in which a plurality of first light sources can emit different wavelengths at different heights;
12 is a view showing an embodiment in which the height or the angle of the surface of the coating layer of the subcutaneous insertion device is changed.

Hereinafter, the present invention will be described in more detail with reference to the drawings according to embodiments thereof.

1 is a schematic diagram showing an optical analyte monitoring system according to an embodiment of the present invention.

The monitoring system of the present embodiment consists of a subcutaneous insertion device 100 inserted under the skin, and an external skin device 500 that is brought into contact with the skin surface.

Figure 2 (a) is a view showing the upper surface (the side facing the skin under the skin) of the hypodermic insertion device 100, Figure 2 (b) is a view showing the lower surface of the hypodermic insertion device (100).

The photovoltaic cell 120 installed on the printed circuit board 110 and functioning as a power generation unit, and a first communication unit 130 for communicating with the external skin device 500 are installed on the upper surface of the subcutaneous insertion device 100 .

The photovoltaic cell 120 is to generate electricity by light emitted from the second light source 520 serving as an energy transfer unit in the external skin device 500 to be described later and penetrated into the skin.

In this embodiment, electricity to be used in the subcutaneous implantation device 100 is generated by the combination of the photovoltaic cell 120 and the second light source, but the energy generated by the energy delivery unit of the external skin device is transmitted by the electromagnetic induction method using a coil. It will also be possible for power generation to take place in the power generation part of the hypodermic insertion device.

In this embodiment, the first communication unit 130 is an optical communication method, and consists of a light receiving unit 131 that receives an optical signal from the outside and an optical transmission unit 132 that transmits an optical signal to the outside.

The optical measurement unit 200 and the first control unit 140 installed on the printed circuit board 110 are installed on the lower surface of the subcutaneous insertion device 100 .

The optical measurement unit 200 measures the first light source 210 emitting light having characteristics such as a wavelength to which the analyte optically reacts, and the reflected/scattered/absorbed/transmitted light passing through the analyte. It is composed of a first photosensor 220 for receiving light.

In the present embodiment, the first light source 210 is composed of a plurality of light sources that generate different wavelengths, but if necessary, one light source of a single wavelength is installed or one light source capable of generating light of several wavelengths It would also be possible to configure

The first photosensor 220 of this embodiment is also composed of a plurality of photosensors that receive different wavelengths, but if necessary, it is arranged as one photosensor that receives a single wavelength or receives light of several wavelengths at the same time. It will also be possible to configure it with one photosensor.

The first control unit 140 controls the first light source 210 , the photocell 120 , and the first communication unit 130 .

It is preferable that the entire surface of the subcutaneous insertion device 100 is coated with a coating layer 150 formed of one of transparent synthetic resin, silicone rubber, ceramic, or glass. It is also possible to cover only the portion requiring insulation of the surface of the hypodermic insertion device 100 .

3 is a view showing the configuration of the external skin device (500).

The external skin device 500 is operated in close contact with the skin surface or at a position spaced apart from the skin surface.

The external skin device 500 is provided with a second communication unit 530 that communicates with the first communication unit 130, and a light so that the photovoltaic cell 120, which is a power generation unit of the subcutaneous insertion device 100, can generate electricity. A second light source 520 for supplying the energy is provided as an energy transfer unit.

The second communication unit 530 and the second light source 520 are controlled by the second control unit 540 .

Since the external skin device 500 is installed on the outside of the skin, it may be driven by various types of power sources, such as an internal storage battery or an external power source.

The external skin device 540 may include a display unit 550 integrally or separately to display optical characteristics of the analyte, and may include a third communication unit 560 to transmit to an external device such as a mobile phone, PC or server. may be

It will also be possible for the first control unit 140 or the second control unit 540 to analyze the characteristics of the light received by the first photosensor 220, and the third communication unit 560 to transmit the signal by the received light as it is. It will also be possible to transmit it to an external device and have the analysis performed on the external device.

The third communication unit 560 is made of known wireless communication such as Bluetooth or Wi-Fi, or a known wired communication means such as a USB connector, to enable communication with an external device.

Each configuration of the subcutaneous insertion device 100 and the external skin device 500 will be described in more detail as follows.

The photovoltaic cell 120 may be manufactured in a size of about 4 mm X 2 mm (width X length) by a method of manufacturing a single crystal silicon photovoltaic cell.

As an example, since the current voltage characteristics of a single crystal silicon photovoltaic cell have a size of 100mm X 100mm, and electricity of 0.6V and 3A can be generated by light, when it is produced with a size of 4mm X 2mm, electricity of about 0.6V and 2.4mA is generated by external light. can be produced by

The generated voltage can be increased to 2 to 3 V or more by connecting several photovoltaic cells of the same size as above in series, and according to this voltage, the battery is charged or the first control unit 140 and the first light source 210 are driven. can

If the storage battery is also produced in a very small size, it is possible to obtain sufficient power to operate the subcutaneous insertion device 100 of the present embodiment.

As an example, when it is said that the capacity of a typical lithium-ion rechargeable battery is 1000 mm X 1000 mm X 5 mm and 3000 mAh current can be charged, it is for insertion under the skin. will have

Since the first light source can be turned on and off as short as several msec or several tens of msec, the actual driving time can be shortened, and charging can be made continuously.

When the storage battery is driven for 1 second, the storage battery capacity becomes 34.56 mAsec, which is sufficient to drive the first light source.

In the present invention, various light sources such as LED, laser diode, and OLED can be used as the light source that can be used as the first light source in the present invention. In particular, it is advantageous to use a light emitting part that can be miniaturized and thinned in order to be inserted under the skin.

Among them, LEDs and laser diodes can produce various wavelengths from visible light to infrared light, and because of their small size, they are suitable for insertion under the skin.

There are various substances under the skin, and each of these substances has a unique absorption wavelength of light.

Since each material may have one or more unique absorption wavelengths, a plurality of light sources of different wavelengths may be installed and used to analyze a single material.

Light sources of several wavelengths may be sequentially emitted to measure each wavelength.

In addition, if a tunable laser diode is used as a light source, even one laser diode can emit light of various wavelengths through control.

For example, by arranging a plurality of LEDs having a wavelength of light at intervals of 20 nm, characteristics by absorption/transmission/reflection of light according to the emission of each LED can be measured. If an LED having each of the peak wavelengths of 440nm, 460nm, 480nm, 500nm, 520nm, ... 1400nm, 1420nm, 1440nm, 1460nm, 1480nm, 1500nm is arranged and you want to light them sequentially, the number of LEDs required is 55 it's a dog

If the size of the LED is made to be 100 micrometer X 100 micrometer and arranged at an interval of 200 micrometers, it can be arranged in about 8 horizontal lines and 7 vertical lines. According to this arrangement, all the LEDs can be arranged within 1.6mm X 1.4mm.

As the manufacturing technology of micro LEDs develops, LEDs can be made more miniaturized. If the LEDs are manufactured in a size of 50 micrometers and arranged at intervals of 100 micrometers, the LEDs can be arranged within an area of 0.8 mm X 0.7 mm.

In the present invention, the first optical sensor may be a Ge substrate, a semiconductor formed on a silicon substrate, or an optical sensor manufactured by a combination of an electron layer and a hole layer using a Group III-V semiconductor including InGaP as a substrate.

When the subcutaneous insertion device is configured with the above configuration, the subcutaneous insertion device is 10 mm wide, 10 mm long, and 2 mm thick, depending on the number of the first light source and the first optical sensor, to 3 mm wide, 3 mm long, and 1 mm thick. It becomes possible to manufacture in size.

The present invention having the above basic configuration will be described according to various embodiments.

4 is a diagram showing the operation relationship of the monitoring system according to an embodiment of the present invention.

In this embodiment, the subcutaneous insertion device 100 is inserted under the skin near the wrist.

The photovoltaic cell 120 of the subcutaneous insertion device 100 receives the light A emitted from the second light source 520 of the external skin device 500 and penetrating under the skin, which is necessary for the operation of the subcutaneous insertion device 100 . will produce electricity. (See Fig. 4(a)))

In addition, the second communication unit (not shown) of the external skin device 500 commands the first communication unit of the hypodermic insertion device 100 to emit the first light source to measure the analyte.

Accordingly, the first light source of the subcutaneous insertion device 100 emits light (B) having a wavelength according to the characteristics of the analyte. The light emitted from the first light source passes through the biological tissue under the skin in the form of reflection/scattering/absorption/transmission, and some of it is received by the first optical sensor along the path indicated by the red dotted line in FIG. 4(b). will become Of course, the light received by the first photosensor is not limited to the path indicated by the dotted line, but may reach the first photosensor through various paths.

The first optical sensor transmits the value detected by the received light to the first control unit of the subcutaneous insertion device for analysis or to the second communication unit of the external skin device through the first communication unit.

The first control unit or the second control unit undergoes an analysis operation such as converting these characteristics of light into a spectrum or light intensity. The analysis result can be read by being transmitted to the display unit of the external skin device or an external device.

The present embodiment is based on the subcutaneous insertion device 100 in which the first light source 210 and the first optical sensor 220 are installed on the lower surface of the printed circuit board 110 as shown in FIG. 2(b).

Figure 5 shows another embodiment of the present invention subcutaneous insertion device.

Unlike the embodiment shown in FIG. 2 , the first light source 210 and the first photosensor 220 in this embodiment are configured to emit and receive light in a direction parallel to the skin surface.

Figure 6 shows another embodiment of the present invention subcutaneous insertion device.

In the subcutaneous insertion device 100 of FIG. 6 , the plurality of first light sources 210 and the first optical sensors 220 are spaced apart to face each other.

The light emitted from the first light source 210 passes through the biological tissue and is reflected/scattered/absorbed/transmitted according to the optical characteristics of the analyte to reach the first optical sensor 220 . The measured optical characteristics of the analyte are transmitted to the second communication unit of the external skin device through the first communication unit 130 .

In the embodiment of Figures 2, 5, and 6, the subcutaneous insertion device consists of one, but in the embodiment shown in Figure 7, the subcutaneous insertion device is separated into two devices, and the first light source 210 is disposed on one device, , the first optical sensor 220 is disposed on the other device. In this embodiment, the distance between the first light source 210 and the first photosensor 220 may be arbitrarily separated. Of course, each side device should be provided with a power generation unit, a communication unit, and a control unit, respectively.

8 is a diagram showing the operational relationship of a monitoring system according to another embodiment of the present invention.

The difference from the previous embodiments is that the first optical sensor 220 is provided in the external skin device 500 .

The first light source 210 emits light in a direction parallel to the skin, and the first optical sensor 220 reflects/scatters/absorbs/transmits the light emitted from the first light source 210 to determine the trajectory that appears on the skin surface. will measure (See Fig. 9)

The trajectory as shown in FIG. 9 is generated according to the optical characteristics of the analyte.

For example, when blood glucose concentration increases, the difference in refractive index with cells constituting the skin decreases, and the amount of light reaching the optical sensor unit increases as the scattering of light decreases, resulting in a narrow and long shape as shown in FIG. 9(a). appears, and when the glucose concentration decreases, a wide and short trajectory D appears as shown in FIG. 9(b) on the contrary.

Accordingly, when the characteristic of the light indicated by the trajectory is measured with the first photosensor, the change in the amount of glucose can be measured.

10 shows that the plurality of first light sources 210 of the subcutaneous insertion device 100 emit light at different angles, and various types of trajectories appear depending on the angle. Such disposition of the first light source makes it possible to adopt a light characteristic that shows well according to various light paths in a non-uniform biological tissue, or to combine and analyze the trajectories of each light source.

11 shows that the plurality of first light sources 210 can emit different wavelengths at different heights. Since the distance to the skin surface varies according to the height difference, the trajectory of light observed on the skin surface is will appear different.

12 shows that the height or direction of the first light source can be changed even by changing the height or the angle of the surface of the coating layer 150 of the hypodermic insertion device 100 without directly changing the height or direction of the first light source. .

10 to 12 , light is emitted in various paths to enable analysis according to each trajectory.

Of course, various image measuring devices such as a camera or an image sensor may be used as the first optical sensor of the external skin device 500 .

The present invention having the above configuration makes it possible to measure blood glucose semi-permanently and continuously as CGMS.

100: subcutaneous insertion device 110: printed circuit board 120: photovoltaic cell
130: first communication unit 131: light receiving unit 132: optical transmitting unit 140: first control unit
150: coating layer
200: optical measuring unit 210: first light source 220: first optical sensor
500: external skin device 520: second light source 530: second communication unit
540: second control unit 550: display unit 560: third communication unit

Claims (19)

An optical measuring unit having a first light source and a first photosensor for measuring optical properties of an analyte;
a photovoltaic cell that generates electricity for operating the optical measuring unit;
a first communication unit for transmitting a signal for controlling the optical measurement unit and the measured optical characteristics of the analyte;
implanting a subcutaneous insertion device having a first control unit for controlling the optical measuring unit, the photocell, and the first communication unit under the skin;

a second optical communication unit communicating with the first communication unit;
a second light source emitting light capable of generating electricity in the photovoltaic cell;
providing an external skin device including a second control unit for controlling the second communication unit and the second light source;

generating electricity by the photovoltaic cell by the light emitted by the second light source of the external skin device;

emitting light from the first light source of the electric furnace optical measuring unit, and measuring the optical characteristics of the emitted light passing through the analyte with the first optical sensor;

Transmitting the measured optical characteristics of the analyte to the second communication unit through the first communication unit; An optical analyte monitoring method using a subcutaneous insertion device, characterized in that it comprises a.
A first light source emitting light for measuring the optical properties of the analyte;
a photovoltaic cell generating electricity for operating the first light source;
implanting a subcutaneous insertion device having a first control unit for controlling the first light source and the photocell under the skin;

a second light source emitting light capable of generating electricity in the photovoltaic cell;
a first photosensor comprising a camera to measure the optical characteristics of the light from the first light source passing through the analyte;
providing an external skin device including a second control unit for controlling the second light source and the first optical sensor;

generating electricity by the photovoltaic cell by the light emitted by the second light source of the external skin device;

An optical analyte using a hypodermic insertion device, characterized in that it comprises; emitting the first light source of the optical measuring means with the developed electricity, and measuring the trajectory displayed on the skin by the emitted light with the first optical sensor monitoring method.
A first light source emitting light for measuring the optical properties of the analyte;
a photovoltaic cell generating electricity for operating the first light source;
a subcutaneous insertion device having a first control unit for controlling the first light source and the photocell;

a second light source emitting light capable of generating electricity in the photovoltaic cell;
to the external skin device including a second control unit for controlling the second light source; is made,

An optical analyte monitoring system using a subcutaneous insertion device, characterized in that the external skin device or a separate device is provided with a camera for measuring a trajectory appearing on the skin by the light of the first light source.
4. The method of claim 3,
The hypodermic insertion device is an optical analyte monitoring system using a hypodermic insertion device, characterized in that it further comprises a storage battery for storing the generated electricity.
delete 4. The method of claim 3,
A first communication unit of an optical communication method installed in the subcutaneous insertion device to transmit a signal for controlling the operation of the first light source;
An optical analyte monitoring system using a subcutaneous insertion device, characterized in that it further comprises a second communication unit of an optical communication method installed on the external skin device to communicate with the first communication unit.
4. The method of claim 3,
The external skin device is provided with a third communication unit, and the optical analyte monitoring system using a subcutaneous insertion device, characterized in that configured to transmit the measurement result to a mobile phone, PC or server.
4. The method of claim 3,
The second control unit is an optical analyte monitoring system using a subcutaneous insertion device, characterized in that it can analyze the trajectory measured by the camera.
delete 4. The method of claim 3,
The external skin device is an optical analyte monitoring system using a subcutaneous insertion device, characterized in that it further comprises a display unit capable of displaying the trajectory of the light received by the camera.
4. The method of claim 3,
The subcutaneous insertion device is an optical analyte monitoring system using a hypodermic insertion device, characterized in that the entire surface is coated with a coating layer formed of one of transparent synthetic resin, silicone rubber, ceramic, or glass.
4. The method of claim 3,
The first light source is an optical analyte monitoring system using a hypodermic insertion device, characterized in that consisting of a plurality of light sources each emitting light of different wavelengths.
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