Continuous blood glucose monitoring and insulin administration device

Abstract

The continuous blood glucose monitoring and insulin administration device according to the present invention includes an insulin supply unit that supplies insulin through an insulin supply tube, a negative pressure generating unit that causes a constant amount of insulin supplied from the insulin supply unit to flow back, an injection unit that includes an injection needle that injects the insulin supplied through the insulin supply tube into the body and a blood glucose measuring sensor that is located in the insulin supply path formed by the insulin supply tube and measures blood glucose, a blood glucose measuring unit that collects blood glucose measurement data measured by the blood glucose measuring sensor, and a control unit that controls the negative pressure generating unit during blood glucose measurement to allow a constant amount of blood to flow into the body through the injection needle and then controls the blood glucose measuring sensor to measure the blood glucose of the inflowing blood.

Description

[Technical Field]

[0001] The present invention relates to a continuous blood glucose monitoring and insulin administration device. [Background technology]

[0002] Conventionally, blood glucose levels have been measured by drawing blood from the fingertip, but this method is painful and has the problem that even if blood is taken only once an hour, it is not possible to grasp fluctuations in blood glucose levels during that interval.

[0003] Continuous glucose monitors are devices developed to continuously measure blood glucose levels. However, among blood glucose measurement methods, invasive methods such as microneedle technology are currently considered more reliable and accurate than non-invasive methods. Because blood glucose measurements are subject to individual variation and differences in the constituent components of biological materials (such as interference effects), selective glucose decomposition methods are considered the most reliable highly sensitive sensor technology capable of measuring even low blood glucose levels.

[0004] However, compared to systems that require a complex measurement procedure, such as using a blood sampler from the fingertip to inject a certain amount of capillary blood into a test strip connected to a measuring device, which can be painful, the microneedle continuous blood glucose monitoring system is one method that can measure blood without the pain and discomfort of blood sampling. It improves user convenience by minimizing the invasive depth of the sensor when the fluid detection needle is inserted subcutaneously after being attached to the measurement site.

[0005] However, when continuous and accurate blood glucose management is required in emergency rooms or intensive care units where acute hyperglycemia patients are present, measuring glucose concentrations from subcutaneous fat or interstitial fluid can be problematic because there may be errors due to time lag or environmental factors compared to blood.

[0006] As a result, in intensive care units and other facilities, blood samples are still taken directly and doctors make decisions based on the samples to administer insulin, which causes inconvenience to both patients and doctors.

[0007] Furthermore, when using a conventional continuous blood glucose monitor and an insulin pump separately, separate needles are required, which poses the problem of requiring separate needles for blood sampling and insulin administration. Even if it is possible to measure blood glucose levels and administer insulin with a single needle using existing devices, the blood glucose monitor sensor contains enzymes used for measuring blood glucose, such as glucose oxidase, and prolonged exposure of these enzymes to blood can cause problems by reacting with components contained in the blood (such as ascorbate, urate, and acetaminophen).

[0008] Furthermore, even if there are no problems with the reaction between these enzymes and blood, when administering insulin and measuring blood glucose levels simultaneously, there is a possibility that blood glucose levels will not be measured accurately because insulin is mixed inside the needle and at the tip of the needle compared to pure blood per unit volume. Summary of the Invention [Problem to be solved by the invention]

[0009] The present invention provides an apparatus that can easily measure and manage blood glucose levels in patients, such as those with acute hyperglycemia, who require accurate measurement of blood glucose levels and, at the same time, continuous blood glucose management. [Means for solving the problem]

[0010] The continuous blood glucose monitoring and insulin administration device of the present invention comprises: ·An insulin supply unit that delivers insulin through an insulin supply tube; a negative pressure generating unit that causes a constant amount of insulin supplied from the insulin supply unit to flow back; an injection part including an injection needle for injecting insulin into the body through the insulin supply tube, and a blood glucose measuring sensor disposed in the insulin supply path formed by the insulin supply tube for measuring blood glucose levels; a blood glucose measuring unit that collects blood glucose measurement data measured from the blood glucose measuring sensor; A control unit that controls the negative pressure generating unit during blood glucose measurement to allow a certain amount of blood to flow into the body through the syringe needle, and then controls the blood glucose measuring sensor to measure the blood glucose level of the blood that has flowed in.

[0011] Furthermore, the negative pressure generating unit includes: a cutoff unit for cutting off insulin supply from the insulin supply unit; a balloon portion configured to expand the cross-sectional area of a certain portion of the insulin delivery tube; A pressure adjusting unit that creates or removes negative pressure outside the balloon unit.

[0012] The control unit controls the pressure adjustment unit to expand the balloon unit while the supply of insulin is blocked through the blocking unit, thereby allowing a constant amount of blood to flow through the injection needle.

[0013] The balloon portion also includes: a balloon formed of an elastic material at a position on the insulin supply tube, the balloon having an expandable outer diameter; A balloon housing that is provided to cover the outside of the balloon and forms a negative pressure forming space between the balloon and the balloon, the negative pressure forming space being connected to the pressure adjusting section by a pressure adjusting path.

[0014] Furthermore, the pressure adjusting unit includes: a hollow cylinder portion, one side of which is connected to the pressure adjusting path; A piston portion accommodated inside the cylinder portion and reciprocating within the cylinder portion to adjust the pressure within the balloon housing.

[0015] The blood glucose measuring sensor can be provided in the insulin supply path at a position adjacent to the injection needle.

[0016] Furthermore, the negative pressure generating section can reverse the flow of blood so that the blood flows back to the blood glucose measuring sensor.

[0017] The control unit can also calculate the amount of blood glucose change per unit time from the blood glucose measurement data transmitted from the blood glucose measurement unit, and increase or decrease the amount of insulin administered so as to adjust the amount of blood glucose change per unit time according to a preset blood glucose adjustment schedule curve. [Effects of the Invention]

[0018] According to the present invention, by enabling patients with acute hyperglycemia in emergency rooms, intensive care units, etc. to inject insulin and measure their blood glucose levels using a single needle, the inconvenience of having to insert an injection needle into the body each time a blood glucose level is measured can be alleviated.

[0019] It also prevents the sensor electrodes from being exposed to blood for long periods of time, preventing them from reacting with the blood.Furthermore, it improves convenience by enabling continuous and accurate blood glucose measurement and management for acute hyperglycemia patients with a single device. [Brief explanation of the drawings]

[0020] [Figure 1] 1 is a block diagram showing a blood glucose measurement and insulin administration device according to one embodiment of the present invention; [Figure 2] FIG. 2 is a schematic diagram illustrating a balloon portion according to one embodiment. [Figure 3] 1 is a schematic diagram showing the structure of an injection part according to one embodiment. FIG. [Figure 4] FIG. 2 is a cross-sectional view showing the structure of a pressure adjusting unit according to an embodiment. [Figure 5] FIG. 10 is a diagram showing the relationship between blood glucose levels and target blood glucose levels over time. DETAILED DESCRIPTION OF THE INVENTION

[0021] The continuous blood glucose monitoring and insulin administration device according to the present invention includes an insulin supply unit that supplies insulin through an insulin supply tube, a negative pressure generating unit that causes a certain amount of insulin supplied from the insulin supply unit to flow back, an injection unit that includes an injection needle that injects the insulin supplied through the insulin supply tube into the body and a blood glucose measuring sensor that is located in an insulin supply path formed by the insulin supply tube and measures blood glucose, a blood glucose measuring unit that collects blood glucose measurement data measured by the blood glucose measuring sensor, and a control unit that controls the negative pressure generating unit during blood glucose measurement to allow a certain amount of blood from the body to flow in through the injection needle and then controls the blood glucose measuring sensor to measure the blood glucose of the inflowing blood.

[0022] The present invention will be described with reference to the accompanying drawings. Unless otherwise specified or otherwise defined, directional terms used in this description are based on the state shown in the drawings. In addition, the same reference numerals refer to the same components in each embodiment. Meanwhile, the thickness and dimensions of each component shown in the drawings may be exaggerated for the sake of explanation, and this does not mean that the components are actually designed based on the corresponding dimensions or ratios between the components.

[0023] A blood glucose measuring and insulin administering device according to one embodiment of the present invention will be described with reference to Fig. 1. Fig. 1 is a block diagram showing a blood glucose measuring and insulin administering device according to one embodiment of the present invention.

[0024] The blood glucose measurement and insulin administration device according to the present invention is a device that simultaneously measures blood glucose levels and administers insulin through a single invasive configuration, and each component will be described in detail below.

[0025] An insulin delivery device (100) according to one embodiment of the present invention includes a control unit (110), a blood glucose measurement unit (120), a negative pressure generating unit (140, 190, 200), an insulin delivery unit (130), and an injection unit (300) equipped with a blood glucose measurement sensor. Among these, the negative pressure generating unit may be configured as, for example, a blocking unit (140), a pressure adjusting unit (190), and a balloon unit (200).

[0026] Specifically, the insulin supply unit 130 supplies insulin through an insulin supply tube forming an insulin supply path P1. The insulin supply unit 130, controlled by the control unit 110, is similar in structure to that of an existing insulin pump.

[0027] The negative pressure generating unit (140, 190, 200) is a component for causing a certain amount of insulin supplied from the insulin supply unit (130) to flow back through the insulin supply path (P1). The negative pressure generating unit can be realized in various ways, such as a bidirectional pump, as long as it is configured to generate negative pressure and cause a certain amount of blood to flow into the body through the insulin supply path.

[0028] The negative pressure generating unit according to this embodiment comprises a blocking unit 140, a pressure adjusting unit 190, and a balloon unit 200. The blocking unit 140 blocks the supply of insulin from the insulin supply unit 130. The blocking unit 140 blocks the supply of insulin by blocking a certain point in the insulin supply path P1, thereby preventing insulin from flowing back from the insulin supply path P1 to the insulin supply unit 130.

[0029] The balloon portion (200) is configured to expand the cross-sectional area of a certain point in the insulin supply tube. The balloon portion (200) expands the cross-sectional area of a certain point in the insulin supply path, thereby temporarily increasing the amount of insulin at that point. Therefore, a certain amount of insulin and blood flows in the reverse direction from the injection portion (300) based on that point.

[0030] The pressure adjusting unit (190) operates to create negative pressure on the outside of the balloon unit (200) to expand the outer diameter of the balloon unit (200), or to release the negative pressure to return the outer diameter of the balloon unit (200) to its original state.

[0031] The injection unit (300) is a component for injecting insulin supplied through an insulin supply tube into the body and measuring blood glucose at the same time, and includes an injection needle (310) and a blood glucose measuring sensor (350).

[0032] The injection needle (310) is an invasive component for invading a blood vessel in the body, and the blood glucose measuring sensor (350) is located in the insulin supply path (P1) formed by the insulin supply tube to measure blood glucose.

[0033] Conventional invasive blood glucose measurement sensors, such as the needle-type blood glucose measurement sensor disclosed in Korean Patent Publication No. 10-2019-0025208 (hereinafter referred to as "Prior Art 1"), are attached to a syringe needle and measured while exposed to blood. However, when attempting to simultaneously measure blood glucose levels and inject insulin using such a sensor, accurate measurement of blood glucose levels becomes difficult because the fluid being measured is mixed with not only blood but also insulin. Furthermore, if the sensor is configured to have blood glucose measurement enzymes, such as glucose oxidase, immobilized between porous sensor electrodes, for example, as an amperometric glucose biosensor, prolonged exposure to ascorbate, urate, or acetaminophen contained in the blood can cause a reaction, reducing sensing efficiency.

[0034] Furthermore, in the case of the above-mentioned prior art 1, since the blood glucose measurement sensor is built into the injection needle, the injection needle itself is made thicker than a typical injection needle for administering insulin, which may cause discomfort to the patient when the needle is inserted into the body.

[0035] However, since the injection part (300) based on this embodiment does not require the blood glucose measurement sensor to be exposed to the end of the needle or to the blood in order to measure blood glucose, the injection needle (310) can be formed with the same thickness as a general injection needle for administering insulin.

[0036] The blood glucose measurement unit (120) collects blood glucose measurement data measured by the blood glucose measurement sensor (350).

[0037] During blood glucose measurement, the control unit (110) controls the negative pressure generating unit (140, 190, 200) to draw a certain amount of blood from the body through the injection needle (310), and then controls the blood glucose measuring unit (120) and the blood glucose measuring sensor (350) to measure the blood glucose level of the drawn blood.

[0038] In addition, the control unit (110) can calculate the amount of blood glucose change per unit time based on the blood glucose measurement data transmitted from the blood glucose measurement unit (120) and increase or decrease the amount of insulin to be administered so as to adjust the amount of blood glucose change per unit time according to a preset blood glucose adjustment schedule curve.

[0039] Furthermore, the control unit (110) may be configured using a separate computer system or a smartphone application, and may be connected to each component of the insulin supply device (100) using a communication means such as a WiFi module.

[0040] Hereinafter, an embodiment of each component will be described in detail.

[0041] The balloon portion according to one embodiment will be specifically described with reference to Fig. 2. Fig. 2 is a schematic diagram showing the balloon portion according to one embodiment.

[0042] The balloon section (200) includes a balloon (215) and a balloon housing (225). The balloon (215) is made of an elastic material at a certain point on the insulin supply tube (210) and is configured to have an expandable outer diameter. The balloon housing (225) is provided to surround the outer periphery of the balloon (215) and is connected to the pressure adjustment unit between the balloon (215) and the balloon (215) by a pressure adjustment tube (220). The pressure adjustment tube (220) forms a pressure adjustment path (P2) between the pressure adjustment unit and the balloon housing (225). The pressure adjustment tube (220) can be formed integrally on the outside of the insulin supply tube (210) or can be formed as a separate tube.

[0043] The balloon housing (225) forms a negative pressure space with the balloon (215). When negative pressure is generated through the pressure regulation path (P2), the balloon (215) expands inside the balloon housing (225). When the internal volume of the balloon (215) increases while the balloon (215) is inflated, insulin present inside the injection part moves from the injection part to the balloon (215) by the amount of the increased volume inside the balloon (215), and at this time, blood in the blood vessel flows in together with the insulin.

[0044] An injection portion according to one embodiment will be described with reference to Fig. 3. Fig. 3 is a schematic diagram showing the appearance of an injection portion according to one embodiment.

[0045] The blood glucose measuring sensor 350 can be installed in the insulin supply path P1 at a position adjacent to the injection needle 310. As described above, the injection unit according to this embodiment allows a certain volume of blood to flow in the reverse direction D2, i.e., in the direction opposite to the insulin supply direction D1, so that the blood can come into contact with the blood glucose measuring sensor 350.

[0046] When administering insulin and measuring blood glucose simultaneously using a conventional needle-integrated sensor, the concentration of insulin relative to the blood volume per unit volume is higher inside the needle and at the tip of the needle, which can lead to problems such as inaccurate blood glucose measurement and reduced sensor efficiency due to prolonged contact with blood. However, the needle according to this embodiment solves these problems by allowing blood to flow in and come into contact with the sensor only when measuring blood glucose.

[0047] The pressure adjusting section according to one embodiment will be described with reference to Fig. 4. Fig. 4 is a cross-sectional view showing the pressure adjusting section according to one embodiment.

[0048] The pressure adjusting unit 190 can be realized in various ways. The pressure adjusting unit 190 according to this embodiment includes a cylinder 191 and a piston 193. The cylinder 191 is hollow, and one side of the cylinder 191 is connected to the pressure adjusting path P2, connecting the space P2-1 inside the cylinder 191 with the pressure adjusting path P2.

[0049] The piston portion (193) is housed inside the cylinder portion (191) and reciprocates within the cylinder portion (191) to adjust the pressure inside the balloon housing.

[0050] The blood glucose measurement and insulin administration process will now be described with reference to FIG.

[0051] The control unit receives blood glucose measurements from the blood glucose sensor and blood glucose measurement unit as described above, generates insulin administration commands for blood glucose management, and sends them to the insulin pump. It measures the insulin dose and the blood glucose change per unit time, and controls the insulin dose according to the blood glucose management plan based on the results.

[0052] Specifically, when negative pressure is generated in the negative pressure generating section, the balloon expands, allowing a certain amount of blood to flow into the injection section, bringing the blood into contact with the blood glucose measuring sensor located inside, and blood glucose is measured. After blood glucose measurement, the negative pressure is released and the balloon returns to its original state, allowing the blood to return to the blood vessel through the injection needle.

[0053] The measured blood glucose data is then used to adjust the insulin dosage and administer insulin. At this time, the control unit sets a target blood glucose level based on the measured blood glucose data and sets a blood glucose adjustment schedule graph as shown in Figure 5 to reach the target blood glucose level. After that, the control unit periodically measures blood glucose in the body, calculates the blood glucose change per unit time, and can increase or decrease the amount of insulin administered to adjust the blood glucose change per unit time according to the preset blood glucose adjustment schedule curve.

[0054] Although the preferred embodiments of the present invention have been described above, the technical idea of the present invention is not limited to the above-described preferred embodiments, and can be realized in various ways without departing from the technical idea of the present invention embodied in the claims.

Claims

1. 1. A continuous blood glucose monitoring and insulin administration device, comprising: an insulin supply unit that supplies insulin through an insulin supply tube; a negative pressure generating unit that causes a certain amount of insulin supplied from the insulin supply unit to flow backward; an injection needle for injecting insulin supplied through the insulin supply tube into the body; an injection part including a blood glucose measuring sensor that is located in an insulin supply path formed by the insulin supply tube and measures blood glucose; a blood glucose measurement unit that collects blood glucose measurement data measured by the blood glucose measurement sensor; a control unit that controls the negative pressure generating unit during blood glucose measurement to allow a certain amount of blood to flow into the body through the syringe needle, and controls the blood glucose measuring sensor to measure the blood glucose of the flowed-in blood; 1. An apparatus comprising:

2. The negative pressure forming unit is a cutoff unit that cuts off the supply of insulin from the insulin supply unit; a balloon portion formed to be able to expand a cross-sectional area of a portion of the insulin delivery tube; a pressure adjusting unit that forms or releases negative pressure on the outside of the balloon unit; Including, The device according to claim 1 , wherein the control unit controls the pressure adjustment unit to expand the balloon unit while the supply of insulin is blocked via the blocking unit, thereby allowing a constant amount of blood to flow through the injection needle.

3. The balloon portion is a balloon formed of an elastic material on a part of the insulin delivery tube so as to be expandable in outer diameter; a balloon housing that is provided to surround the outside of the balloon and forms a negative pressure forming space connected to the pressure adjusting unit between the balloon and the balloon; The apparatus of claim 2 , comprising:

4. The pressure adjusting unit is a cylinder portion formed in a hollow shape and one side of which is connected to the pressure adjustment path; a piston portion accommodated inside the cylinder portion and reciprocating within the cylinder portion to adjust the pressure inside the balloon housing; The apparatus of claim 3 , comprising:

5. 2. The device of claim 1, wherein the blood glucose measuring sensor is located in the insulin delivery pathway adjacent to the injection needle.

6. The device according to claim 5 , wherein the negative pressure generating unit reverses the flow of blood so that the blood flows back to the blood glucose measuring sensor.

7. 2. The device according to claim 1, wherein the control unit calculates the amount of blood glucose change per unit time based on the blood glucose measurement data sent from the blood glucose measurement unit, and increases or decreases the amount of insulin to be administered so as to adjust the amount of blood glucose change per unit time based on a preset blood glucose adjustment schedule curve.

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