Implantable continuous blood glucose measurement device and system

Abstract

The present invention generally relates to implantable continuous blood glucose measurement technology. In particular, the present invention relates to an implantable continuous blood glucose measurement device for continuously measuring blood glucose in the body of a user, in which an oscillator for generating a variable frequency output signal corresponding to a voltage or current applied to both ends thereof is connected to a glucose fuel cell for generating electrical energy by glucose in the body, comprises an LED element, which is turned on or off by the output signal of the oscillator, or an antenna for wirelessly transmitting the output signal of the oscillator. The present invention has the advantage that blood glucose can be continuously measured in a state in which a blood glucose sensor is implanted in the body, without having to replace same.

Description

Implantable continuous blood glucose monitoring device and system

[0001] The present invention generally relates to implantable continuous blood glucose monitoring technology.

[0002] In particular, the present invention relates to an implantable continuous blood glucose measuring device for continuously measuring blood glucose in a user's body, which comprises an oscillator that generates an output signal of a variable frequency corresponding to a voltage or current applied to both ends connected to a glucose fuel cell that generates electrical energy by glucose in the body, and an LED element that is turned on and off by the oscillator output signal or an antenna that wirelessly transmits the oscillator output signal.

[0003] Diabetes is a disease that occurs when the body fails to produce or has insufficient insulin, which controls blood sugar levels, or when the insulin function declines. The number of people with diabetes is steadily increasing.

[0004] Blood sugar refers to the concentration of glucose (C6H12O6) in the blood. In diabetic patients, low blood sugar can cause lethargy and, in severe cases, brain damage and death. Conversely, high blood sugar can lead to metabolic diseases. Impaired fasting glucose (IFG) is a pre-diabetic condition. It is estimated that approximately 27% of the population aged 30 and older has IFG. These individuals must strictly manage their blood sugar levels to prevent the progression to diabetes.

[0005] Self-monitoring of blood sugar levels is very important for people with diabetes or impaired fasting glucose because it helps them manage their blood sugar levels on a regular basis.

[0006] Figure 1 is a diagram showing a general blood sugar measurement principle.

[0007] Blood glucose meters typically utilize enzyme sensors. These sensors consist of glucose oxidase, which oxidizes glucose to gluconic acid; a stabilizer that promotes the enzymatic reaction and prevents deterioration; an electrode made of carbon or platinum; and a redox mediator that facilitates low-voltage measurement of the enzyme's redox reaction. This method measures the amount of current generated by the electrons that move to the electrode during the process in which glucose oxidase oxidizes glucose in the blood.

[0008] Traditionally, methods for measuring glucose in the blood have been used, but recently methods for measuring glucose in interstitial fluid or in sweat have also been used.

[0009] Enzyme-free glucose sensing technology, also known as enzyme-free glucose sensing, is also being used to measure blood sugar levels without using enzymes. Enzyme sensors, however, suffer from stability and accuracy issues due to pH, temperature, humidity, and the passage of time, and this technology aims to improve these issues. Enzyme-free glucose sensing technology utilizes nanopolymer composite materials or nanoporous platinum.

[0010] Figure 2 is a drawing showing a conventional blood sugar measurement technology.

[0011] Figure 2 (a) shows a BGM (Blood Glucose Monitoring) product. BGM measures blood sugar levels by pricking a finger with a small pin, drawing blood, and then placing it on a test strip. BGM holds a 98% market share in the blood glucose meter market.

[0012] Figures 2 (b) and (d) illustrate CGM (Continuous Glucose Monitoring) products. Figure 2 (b) features a blood glucose sensor attached to the arm or abdomen, which is replaced approximately every 14 days. Figure 2 (c) features a blood glucose sensor inserted under the skin to measure blood glucose levels, then a microneedle is inserted to read the readings. Blood glucose sensors inserted into the body are replaced every three to six months. Implantable CGMs, also known as implantable CGMs, have the disadvantages of leaving scars and being expensive.

[0013] Figure 2 (d) illustrates non-invasive CGM technology. Non-invasive GCM is a technology that measures blood glucose levels using infrared or laser while a wearable device is placed in close contact with a subcutaneous blood vessel. Non-invasive CGM is not yet stabilized.

[0014] Figure 3 is a drawing showing a continuous blood glucose measurement device currently on the market.

[0015] Continuous glucose monitoring devices are generally used for wellness and medical purposes. Currently, companies such as Medtronic, Dexcom, and Abbott, which sell minimally invasive CGM products, are leading the market and have established monopolies.

[0016] However, consumer surveys of these CGM products show satisfaction levels of less than 50%. Therefore, efforts to improve continuous glucose monitoring devices are needed.

[0017] Meanwhile, prior literature related to the present invention is as follows.

[0018] (1) Republic of Korea Patent No. 10-2305548 “Blood sugar measurement device and method”

[0019] (2) Republic of Korea Patent No. 10-1925632 “Intrabody implantable blood glucose measurement device and method”

[0020] (3) Republic of Korea Publication Patent No. 10-2022-0046307 “Blood Sugar Measurement Device”

[0021] (4) Kim Jong-deok and Kim Bong-gyu, "Non-invasive continuous glucose monitoring technology trends," Electronic Communication Trend Analysis, Vol. 36, No. 5, 2021, pp. 9-20.

[0022] (5) Philipp Simons et al., “A Ceramic-Electrolyte Glucose Fuel Cell for Implantable Electronics,” Advanced Materials, vol. 34, issue 24, 2022.

[0023] An object of the present invention is generally to provide an implantable continuous blood glucose monitoring technology.

[0024] In particular, the purpose of the present invention is to provide an implantable continuous blood glucose measuring device for continuously measuring blood glucose in a user's body, which comprises an oscillator that generates an output signal of a variable frequency corresponding to a voltage or current applied at both ends to a glucose fuel cell that generates electrical energy by glucose in the body, and an LED element that is turned on and off by the oscillator output signal or an antenna that wirelessly transmits the oscillator output signal.

[0025] To achieve the above purpose, the present invention proposes an implantable continuous blood glucose measurement device and system.

[0026] The implantable continuous blood glucose measuring device according to the present invention comprises: a glucose fuel cell (110) that generates electrical energy by glucose in the body; an oscillator (120) that generates an output signal of a variable frequency corresponding to a voltage applied to both ends or a current applied to both ends, the oscillator (120) being connected to an anode terminal (A) and a cathode terminal (K) of the glucose fuel cell (110) and generating an output signal having a frequency corresponding to the output voltage or output current of the glucose fuel cell (110); and a wireless transmitter (130) that is connected to the oscillator (120) and wirelessly transmits physical information driven by the output signal of the oscillator (120).

[0027] The implantable continuous blood glucose measuring device according to the present invention may further include a wireless power receiver (140) that receives RF wireless power from the outside and provides operating power to at least one of an oscillator (120) and a wireless transmitter (130).

[0028] At this time, the oscillator (120) may be configured to include a semiconductor ring oscillator.

[0029] Additionally, the wireless transmitter (130) may be configured to include an LED indicator (131) whose light output is turned on or off by an output signal of the oscillator (120). At this time, the LED indicator (131) may be configured to include an infrared LED element.

[0030] Additionally, the wireless transmitter (130) may be configured to include a transmission antenna (132) that is driven by an output signal of an oscillator (120) and transmits a wireless signal.

[0031] Meanwhile, the implantable continuous blood glucose measurement system according to the present invention may be configured to include a user blood glucose display unit (200) that includes an implantable continuous blood glucose measurement device (100) that is inserted under the user's skin; a photo detector (211) that detects the light output of an LED indicator (131) of the implantable continuous blood glucose measurement device (100), a frequency extraction unit (220) that extracts the on / off frequency of the light output from the detection result of the photo detector (211), a blood glucose calculation unit (230) that calculates a blood glucose measurement value from the on / off frequency, and a blood glucose output unit (240) that outputs the calculated blood glucose measurement value to the user, thereby displaying a blood glucose measurement value by the implantable continuous blood glucose measurement device (100) to the user.

[0032] In addition, the implantable continuous blood glucose measurement system according to the present invention may be configured to include a user blood glucose display unit (200) that includes an implantable continuous blood glucose measurement device (100) that is inserted under the skin of a user; a receiving antenna (212) that receives a wireless signal transmitted by a transmitting antenna (132) of the implantable continuous blood glucose measurement device (100), a frequency extraction unit (220) that extracts a frequency of the wireless signal from a reception result of the receiving antenna (212), a blood glucose calculation unit (230) that calculates a blood glucose measurement value from the frequency of the wireless signal, and a blood glucose output unit (240) that outputs the calculated blood glucose measurement value to the user, thereby displaying a blood glucose measurement value by the implantable continuous blood glucose measurement device (100) to the user.

[0033] At this time, in the implantable continuous blood glucose measurement system according to the present invention, the user blood glucose display unit (200) may further include a wireless power transmitter (250) that transmits RF wireless power to the implantable continuous blood glucose measurement device (100).

[0034] According to the present invention, there is an advantage in that blood sugar can be continuously measured in a non-replaceable manner with the blood sugar sensor inserted into the body.

[0035] Figure 1 is a diagram showing the conventional blood sugar measurement principle.

[0036] Figure 2 is a drawing showing a conventional blood sugar measurement technology.

[0037] Figure 3 is a drawing showing a continuous blood glucose measurement device currently on the market.

[0038] Figure 4 is a configuration diagram of an implantable continuous blood glucose measurement system according to one embodiment of the present invention.

[0039] Figure 5 is a circuit diagram of an embodiment of a semiconductor ring oscillator in the present invention.

[0040] Figure 6 is a configuration diagram of an embodiment of wirelessly transmitting blood sugar information in the present invention.

[0041] Figure 7 is an embodiment of the device configuration of an implantable continuous blood glucose measuring device according to the present invention.

[0042] Figure 8 is a drawing showing an embodiment of the present invention in which a continuous blood glucose measurement device is inserted into the body.

[0043] Figure 9 is a drawing showing an embodiment of a micro LED member in the present invention.

[0044] Figure 10 is a configuration diagram of an implantable continuous blood glucose measurement system according to another embodiment of the present invention.

[0045] Figure 11 is a block diagram of an implantable continuous blood glucose measurement system according to another embodiment of the present invention.

[0046] Hereinafter, the present invention will be described in detail with reference to the drawings.

[0047] In explaining the present invention, detailed descriptions of parts that overlap with the prior art may be omitted.

[0048] Figure 4 is a configuration diagram of an implantable continuous blood glucose measurement system according to one embodiment of the present invention.

[0049] The implantable continuous blood glucose measurement system according to the present invention comprises a continuous blood glucose measurement device (100) and a user blood glucose display unit (200). The continuous blood glucose measurement device (100) is a device that is inserted into a user's body, preferably under the skin, to measure the user's blood glucose level in real time. In addition, the user blood glucose display unit (200) is a device that exists outside the user's body and displays blood glucose measurement results to the user. The user blood glucose display unit (200) may be implemented as a dedicated terminal device or in the form of a smart terminal.

[0050] Referring to FIG. 4, the continuous blood glucose measurement device (100) is configured to include a glucose fuel cell (110), an oscillator (120), and a wireless transmitter (130). In addition, the user blood glucose display unit (200) is configured to include a wireless detector (210), a frequency extraction unit (220), a blood glucose calculation unit (230), and a blood glucose output unit (240).

[0051] First, let's look at the configuration of the continuous blood glucose measurement device (100).

[0052] A glucose fuel cell (110) is a device that generates electrical energy using glucose inside the human body, and is also called a biofuel cell.

[0053] A glucose fuel cell (110) operates on the principle of generating electricity by inducing a chemical reaction using glucose and oxygen present in bodily fluids (blood or other body fluids) within the human body. Since glucose is always present in the body, external charging is unnecessary and glucose fuel cells have the characteristic of stably providing low power. Therefore, glucose fuel cells have been used as a power source for bio-implantable devices (e.g., implantable sensors, pacemakers). In the present invention, the glucose fuel cell (110) functions as a sensor inserted into the body to measure blood sugar levels.

[0054] In Fig. 4, a glucose fuel cell (110) is configured as one stage, but depending on the implementation example, it can be configured as multiple stages (2 to 5 stages) in series.

[0055] The oscillator (120) is a component that generates an output signal of variable frequency corresponding to the applied voltage or current at both ends. In the present invention, the oscillator (120) is connected to the anode terminal (A) and the cathode terminal (K) of the glucose fuel cell (110) to generate an output signal having a frequency corresponding to the output voltage or output current of the glucose fuel cell (110).

[0056] At this time, it is advantageous for miniaturization and power saving to configure an oscillator (120) including a semiconductor ring oscillator. A semiconductor ring oscillator is a circuit that generates oscillation by connecting inverter circuits in a ring shape (closed loop) and is conventionally used for characteristic analysis of semiconductor chips or measuring operating speed. In general, a semiconductor ring oscillator exhibits the characteristic that the frequency increases in proportion to the voltage applied to both ends.

[0057] Fig. 5 is a circuit diagram of two embodiments of a semiconductor ring oscillator according to the present invention. The circuit diagram of Fig. 5 is an example implemented as a low-power circuit, considering that the standard output voltage of a single-stage glucose fuel cell (110) is approximately 0.5 volts. If multiple stages of glucose fuel cells (110) are connected in series to output a high voltage (e.g., 2.0 volts), a semiconductor ring oscillator having a different topology can be adopted.

[0058] The frequency of the output signal of the oscillator (120) changes depending on the user's blood sugar level. Since the glucose fuel cell (110) generates electrical energy from the glucose in the body, the higher the blood sugar level, the more electrical energy is generated. That is, in FIG. 4, the movement of charges (e-) becomes active, causing the voltage and current to increase. Since the oscillator (120) has the characteristic of changing the frequency of the output signal in response to the voltage or current applied to both ends, the frequency changes in response to the blood sugar level. Generally, the higher the blood sugar level, the higher the frequency of the oscillator (120).

[0059] According to the inventor's experiment, when a semiconductor ring oscillator (120) is connected to a single-stage glucose fuel cell (110), the oscillator (120) exhibits a frequency of about 100 kHz in the case of a normal person.

[0060] The wireless transmitter (130) is a component that is connected to the oscillator (120) and wirelessly transmits physical information driven by the output signal of the oscillator (120).

[0061] Figure 6 is a configuration diagram of two embodiments of wirelessly transmitting blood sugar information in the present invention.

[0062] In the embodiment of Fig. 6 (a), the wireless transmitter (130) is configured with an LED indicator (131). The LED indicator (131) is driven to turn on or off its light output by an output signal of the oscillator (120). For example, while the output signal of the oscillator (120) is high, the LED indicator (131) is turned on and light is output, and while the output signal of the oscillator (120) is low, the LED indicator (131) is turned off and light is turned off. Therefore, the LED indicator (131) is turned on and off in response to the frequency of the oscillator (120).

[0063] The photo detector (211) of the user blood sugar display unit (200) detects the turn-on or turn-off of the LED indicator (131), and from this, the user blood sugar display unit (200) can extract the frequency of the oscillator (120).

[0064] At this time, it is preferable that the LED indicator (131) be configured to include an infrared LED element. This is because infrared (IR) has a long wavelength and can easily penetrate human skin and exit the body, and is therefore less affected by the body-embedded environment of the continuous blood glucose measurement device (100).

[0065] In the embodiment of Fig. 6 (b), the wireless transmitter (130) is configured with a transmission antenna (132). The transmission antenna (132) is driven by an output signal of an oscillator (120) to transmit a wireless signal. The receiving antenna (212) of the user blood sugar display unit (200) receives this wireless signal, and from this, the user blood sugar display unit (200) can extract the frequency of the oscillator (120).

[0066] Next, we will look at the configuration of the user blood sugar display unit (200).

[0067] The user blood sugar display unit (200) is a component that exists outside the user's body and wirelessly receives information from a continuous blood sugar measurement device (100) inserted into the body and displays the blood sugar measurement value to the user. Referring to FIG. 4, the user blood sugar display unit (200) is configured to include a wireless detector (210), a frequency extraction unit (220), a blood sugar calculation unit (230), and a blood sugar output unit (240).

[0068] The wireless detector (210) is a component that receives physical information wirelessly transmitted by the wireless transmitter (130) of the continuous blood glucose measurement device (100). In the first embodiment, the wireless detector (210) is configured with a photo detector (211). The photo detector (211) detects the turning on or off of the LED indicator (131) of the continuous blood glucose measurement device (100) from the light output of the LED indicator (131). In the second embodiment, the wireless detector (210) is configured with a receiving antenna (212). The receiving antenna (212) receives a wireless signal transmitted by the transmitting antenna (132) of the continuous blood glucose measurement device (100).

[0069] The frequency extraction unit (220) extracts the frequency of the oscillator (120) from the reception result of the wireless detector (210). In the first embodiment, the frequency extraction unit (220) extracts the on / off frequency of the optical output from the detection result of the photo detector (211). In the second embodiment, the frequency extraction unit (220) extracts the frequency of the wireless signal from the reception result of the receiving antenna (212).

[0070] The blood sugar calculation unit (230) calculates a blood sugar measurement value from the frequency of the oscillator (120) extracted by the frequency extraction unit (220). As the blood sugar level of the user increases, the voltage and current generated by the glucose fuel cell (110) increase, and accordingly, the frequency of the output signal generated by the oscillator (120) also tends to increase. It is preferable to obtain the correspondence between the blood sugar level and the frequency in advance through experimentation and store it in the form of a table. Based on this correspondence, the blood sugar calculation unit (230) can calculate a blood sugar measurement value from the frequency of the oscillator (120).

[0071] The blood sugar output unit (240) outputs the blood sugar measurement value calculated by the blood sugar calculation unit (230) to the user.

[0072] FIG. 7 is an embodiment of the device configuration of a continuous blood glucose measurement device (100) implantable in the body according to the present invention, and FIG. 8 is a drawing showing an embodiment of the continuous blood glucose measurement device implanted in the body according to the present invention.

[0073] Referring to FIG. 7, the glucose fuel cell (110) and circuit components (120, 131) are configured as separate blocks, and are connected to the anode (A) and cathode (K) of the glucose fuel cell (110). At this time, the anode (A) and cathode (K) function as bumping nodes from a mechanical perspective.

[0074] Referring to Fig. 8, a continuous blood glucose measurement device (100) is inserted under the user's skin. Fig. 8 (a) is an embodiment using an LED indicator (131), and Fig. 8 (b) is an embodiment using a transmission antenna (132).

[0075] Fig. 9 is a drawing showing one embodiment of an LED indicator (131) in the present invention.

[0076] The LED indicator (131) can be implemented as a micro LED display element. These elements can be driven with a small current of 0.1 to 10 μA. When implementing a glucose fuel cell (110) into the human body, it is important to implement it in a small size. Therefore, implementing the LED indicator (131) as a micro LED display element is highly desirable for implantation into the body, as it can operate with the small power supplied by the small-sized glucose fuel cell (110).

[0077] FIG. 10 and FIG. 11 are a configuration diagram and a block diagram of an implantable continuous blood glucose measurement system using wireless power supply according to another embodiment of the present invention.

[0078] If the output voltage provided by the glucose fuel cell (110) is low or the power is insufficient, it may be difficult to stably operate the oscillator (120) and the wireless transmitter (130).

[0079] In this case, the continuous blood glucose measurement device (100) is configured to receive operating power for the oscillator (120) and / or wireless transmitter (130) from the outside by wireless power supply through a separate channel.

[0080] To this end, the implantable continuous blood glucose measurement device (100) is equipped with a wireless power receiver (140), and the user blood glucose display unit (200) is equipped with a wireless power transmitter (250). The wireless power transmitter (250) transmits RF wireless power to the implantable continuous blood glucose measurement device (100). The wireless power receiver (140) receives RF wireless power from the wireless power transmitter (250) and provides operating power to at least one of the oscillator (120) and the wireless transmitter (130).

Claims

1. Glucose fuel cell (110) that generates electrical energy using glucose in the body; An oscillator (120) that generates an output signal of variable frequency corresponding to a double-ended voltage or a double-ended current, the oscillator (120) being connected to the anode terminal (A) and the cathode terminal (K) of the glucose fuel cell (110) and generating an output signal having a frequency corresponding to the output voltage or output current of the glucose fuel cell (110); and A wireless transmitter (130) connected to the above oscillator (120) and wirelessly transmitting physical information driven by an output signal of the above oscillator (120); An implantable continuous blood glucose monitoring device comprising:

2. In claim 1, An implantable continuous blood glucose measuring device characterized in that the above oscillator (120) comprises a semiconductor ring oscillator.

3. In claim 1, An implantable continuous blood glucose measurement device characterized in that the wireless transmitter (130) comprises an LED indicator (131) whose light output is turned on or off by the output signal of the oscillator (120).

4. In claim 3, An implantable continuous blood glucose measuring device characterized in that the LED indicator (131) includes an infrared LED element.

5. In claim 1, An implantable continuous blood glucose measurement device characterized in that the wireless transmitter (130) is configured to include a transmission antenna (132) that transmits a wireless signal by being driven by an output signal of the oscillator (120).

6. In claim 1, A wireless power receiver (140) that receives RF wireless power from the outside and provides operating power to at least one of the oscillator (120) and the wireless transmitter (130); An implantable continuous blood glucose monitoring device comprising:

7. An implantable continuous blood glucose measuring device (100) according to claim 3, which is inserted under the user's skin; and A user blood sugar display unit (200) that displays a blood sugar measurement result by the body-implantable continuous blood sugar measurement device (100) to the user, comprising a photo detector (211) that detects the light output of the LED indicator (131), a frequency extraction unit (220) that extracts the on / off frequency of the light output from the detection result of the photo detector (211), a blood sugar calculation unit (230) that calculates a blood sugar measurement value from the on / off frequency, and a blood sugar output unit (240) that outputs the calculated blood sugar measurement value to the user; An implantable continuous blood glucose monitoring system comprising:

8. In claim 7, An implantable continuous blood glucose measurement system characterized in that the user blood glucose display unit (200) further includes a wireless power transmitter (250) that transmits RF wireless power to the implantable continuous blood glucose measurement device (100).

9. An implantable continuous blood glucose measuring device (100) according to claim 5, which is inserted under the user's skin; and A user blood sugar display unit (200) that displays a blood sugar measurement result by the body-implantable continuous blood sugar measurement device (100) to the user, comprising a receiving antenna (212) that receives a wireless signal transmitted by the transmitting antenna (132) of the body-implantable continuous blood sugar measurement device (100), a frequency extraction unit (220) that extracts a frequency of the wireless signal from a reception result of the receiving antenna (212), a blood sugar calculation unit (230) that calculates a blood sugar measurement result from the frequency of the wireless signal, and a blood sugar output unit (240) that outputs the calculated blood sugar measurement result to the user; An implantable continuous blood glucose monitoring system comprising:

10. In claim 9, An implantable continuous blood glucose measurement system characterized in that the user blood glucose display unit (200) further includes a wireless power transmitter (250) that transmits RF wireless power to the implantable continuous blood glucose measurement device (100).

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