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 an apparatus for continuous blood glucose measurement and insulin administration.

Background Art

[0002] Conventionally, blood has been collected from a fingertip to measure blood glucose levels. In this method, there is a problem that it is painful due to blood collection, and even when measuring only once an hour, it is impossible to grasp the fluctuations in blood glucose levels during the measurement interval.

[0003] Continuous blood glucose monitors are devices developed to be able to continuously measure blood glucose levels. However, among the methods of blood glucose measurement, at present, the methods that are considered to be more reliable and accurate than non-invasive methods are invasive methods such as the microneedle method. Since there are individual differences in blood glucose measurement and differences in the constituent components (interference effects, etc.) of biological substances, the method of selectively decomposing glucose is considered to be the most reliable as a highly sensitive sensor technology capable of measuring up to low blood glucose levels.

[0004] However, compared to a system with a complicated measurement procedure of injecting a certain amount of capillary blood into a test strip connected to a measuring device while causing pain using a blood collection device from a fingertip, the microneedle method, which is one of the methods that can avoid the pain and discomfort of blood collection and perform measurement, can improve the convenience for users by minimizing the sensor invasion depth when a fluid detection type needle is inserted subcutaneously after being attached to the measurement site.

[0005] However, when continuous and accurate blood glucose level management is required in an emergency room or intensive care unit where there are patients with acute hyperglycemia, etc., measuring glucose concentration from subcutaneous fat or interstitial fluid may cause problems because errors due to time differences and environmental errors may occur compared to blood.

[0006] Therefore, in intensive care units and other similar settings, blood is still drawn directly, and doctors make decisions based on those results to administer insulin, which is inconvenient for both patients and doctors.

[0007] Furthermore, when using conventional continuous glucose monitors and insulin pumps separately, it is necessary to use separate needles, which presents the problem of having to use different needles for blood collection and insulin administration. In addition, even if it is possible to measure blood glucose levels and administer insulin with a single needle using existing devices, the sensors of glucose monitors contain enzymes for measuring blood glucose, such as glucose oxidase. If these enzymes are exposed to the blood for a long period of time, there is a possibility that they may react with components in the blood (ascorbate, urate, acetaminophen, etc.).

[0008] Furthermore, even if there are no problems with the reaction between these enzymes and blood, when insulin is administered and blood glucose levels are measured simultaneously, the presence of insulin mixed in the needle and at the tip of the needle, compared to the amount of pure blood per unit volume, can lead to inaccurate blood glucose measurements. [Overview of the Initiative] [Problems that the invention aims to solve]

[0009] The present invention provides a device that allows for easy measurement and management of blood glucose levels in situations where accurate measurement of blood glucose levels is necessary, such as in patients with acute hyperglycemia, and where continuous blood glucose management is required. [Means for solving the problem]

[0010] The device for continuous blood glucose monitoring and insulin administration according to the present invention includes the following: • 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 above-mentioned insulin supply unit to flow back into the negative pressure unit; An injection unit comprising a needle for injecting insulin supplied through the insulin supply tube into the body, and a blood glucose sensor positioned within the insulin supply pathway formed by the insulin supply tube for measuring blood glucose levels; • A blood glucose measurement unit that collects blood glucose measurement data measured from the above-mentioned blood glucose measurement sensor; A control unit that controls the negative pressure formation section 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 measurement sensor to measure the blood glucose level of the incoming blood.

[0011] Furthermore, the negative pressure forming section includes the following: • A blocking unit that blocks the supply of insulin from the above-mentioned insulin supply unit; • A balloon portion formed to expand the cross-sectional area at a certain location in the insulin supply tube; • A pressure adjustment unit that creates or removes negative pressure on the outside of the balloon section.

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

[0013] Furthermore, the balloon section includes the following: • A balloon formed of elastic material at a location within the insulin supply tube, with an expandable outer diameter; A balloon housing provided to cover the outside of the balloon, forming a negative pressure-forming space between itself and the balloon, which is connected to the pressure adjustment section by a pressure adjustment path.

[0014] Furthermore, the above pressure adjustment unit includes the following: • A cylinder section formed in a hollow shape, with one end connected to the pressure adjustment path; A piston section housed inside the cylinder section and reciprocating within the cylinder section to adjust the pressure inside the balloon housing.

[0015] In addition, the blood glucose measurement sensor can be provided at a position adjacent to the injection needle in the insulin supply path.

[0016] Furthermore, the negative pressure forming part can reverse the flow of the inflowing blood so that the blood flows to the blood glucose measurement sensor.

[0017] In addition, the control unit calculates the amount of change in blood glucose per unit time from the blood glucose measurement data transmitted from the blood glucose measurement unit, and increases or decreases the amount of insulin administered so as to adjust the amount of change in blood glucose per unit time according to a preset blood glucose adjustment schedule curve.

Advantages of the Invention

[0018] According to the present invention, in an emergency room, an intensive care unit, etc., for a patient with acute hyperglycemia, by enabling insulin injection and blood glucose measurement to be performed with a single needle, it is possible to reduce the inconvenience of having to pierce the human body with an injection needle every time blood glucose is measured.

[0019] In addition, it has the effect of preventing the electrodes of the sensor from being exposed to blood for a long time and preventing reaction with blood. Furthermore, the convenience is improved because continuous and accurate measurement and management of blood glucose values of acute hyperglycemia patients can be achieved with one device.

Brief Description of the Drawings

[0020] [Figure 1] It is a block diagram showing a blood glucose measurement and insulin administration device according to an embodiment of the present invention. [[ID=

[29] ] [Figure 2] It is a schematic diagram showing a balloon part according to an embodiment. [Figure 3] It is a schematic diagram showing the structure of an injection part according to an embodiment. [Figure 4] It is a cross-sectional view showing the structure of a pressure adjustment part according to an embodiment. [Figure 5] It is a diagram showing the relationship between blood glucose value and target blood glucose value over time.

Best Mode for Carrying Out the Invention

[0021] The continuous blood glucose measurement 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 forming unit that causes a certain amount of the insulin supplied from the insulin supply unit to flow backward, an injection needle that injects the insulin supplied through the insulin supply tube into the body, and an injection unit that includes a blood glucose measurement sensor 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, and a control unit that controls the negative pressure forming unit at the time of blood glucose measurement to control the blood glucose measurement sensor to measure the blood glucose of the inflowed blood while causing a certain amount of body blood to flow into the body through the injection needle.

[0022] Embodiments of the present invention will be described with reference to the accompanying drawings. Unless otherwise defined or referred to, terms indicating directions used in this description are based on the states shown in the drawings. Also, the same reference numerals in each embodiment refer to the same members. On the other hand, each configuration shown in the drawings may be exaggerated in thickness and dimensions for convenience of explanation, and it does not mean that it is actually designed based on the corresponding dimensions and the ratio between the configurations.

[0023] Referring to FIG. 1, a blood glucose measurement and insulin administration device according to an embodiment of the present invention will be described. FIG. 1 is a block diagram showing a blood glucose measurement and insulin administration device according to an 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 one invasive configuration. Hereinafter, each component will be specifically described.

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

[0026] Specifically, the insulin supply unit (130) supplies insulin through an insulin supply tube that forms an insulin supply pathway (P1). The insulin supply unit (130), controlled by the control unit (110), is largely similar in configuration to existing insulin pumps.

[0027] The negative pressure generating units (140, 190, 200) are components that cause a certain amount of insulin supplied from the insulin supply unit (130) to flow back through the insulin supply pathway (P1). The negative pressure generating units can be implemented in various ways, similar to bidirectional drive pumps, as long as they are configured to create negative pressure and cause a certain amount of blood to flow into the body through the insulin supply pathway.

[0028] The negative pressure forming section according to this embodiment includes a blocking section (140), a pressure adjustment section (190), and a balloon section (200). The blocking section (140) blocks the supply of insulin from the insulin supply section (130). The blocking section (140) blocks the supply of insulin by blocking a certain point in the insulin supply pathway (P1), preventing insulin from flowing back from the insulin supply pathway (P1) to the insulin supply section (130).

[0029] The balloon portion (200) is formed to expand the cross-sectional area at a certain point in the insulin supply tube. The balloon portion (200) functions to temporarily increase the amount of insulin at a certain point in the insulin supply pathway by expanding the cross-sectional area at that point. Therefore, a certain amount of insulin and blood flows in in the reverse direction from the injection portion (300) side with respect to that point.

[0030] The pressure adjustment unit (190) operates to create negative pressure on the outside of the balloon section (200), thereby expanding the outer diameter of the balloon section (200), or to release the negative pressure and return the outer diameter of the balloon section (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 simultaneously measuring blood glucose, and comprises an injection needle (310) and a blood glucose measurement sensor (350).

[0032] The injection needle (310) is an invasive component for entering the blood vessels in the body, and the blood glucose sensor (350) is located within the insulin supply pathway (P1) formed by the insulin supply tube to measure blood glucose.

[0033] Conventional invasive blood glucose monitoring sensors have been implemented in a type that is attached to an injection needle and measures glucose concentration in the blood while exposed to blood, such as the needle-type blood glucose monitoring sensor disclosed in Korean Published Patent No. 10-2019-0025208 (hereinafter referred to as "Prior Art 1"). However, when attempting to measure blood glucose levels and inject insulin into the body simultaneously using such a sensor, not only is accurate measurement of blood glucose levels difficult because insulin is mixed with the fluid being measured, as is blood. Furthermore, if the sensor is configured such as an amperometric glucose biosensor in which blood glucose measuring enzymes such as glucose oxidase are fixed between porous sensor electrodes, prolonged exposure to ascorbates, urates, or acetaminophen contained in the body's blood may cause a reaction and reduce sensing efficiency.

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

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

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

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

[0038] Furthermore, the control unit (110) calculates 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 can increase or decrease the amount of insulin administered 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) can be configured with a separate computer system or a smartphone application, and can be connected to each component of the insulin supply device (100) using communication means such as a WiFi module.

[0040] The following describes in detail the embodiments of each component.

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

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

[0043] The balloon housing (225) forms a negative pressure space between itself and the balloon (215). When negative pressure is formed through the pressure adjustment pathway (P2), the balloon (215) expands inside the balloon housing (225). When the balloon (215) is expanded and its internal volume increases, insulin that was present inside the injection site moves from the injection site side to the balloon (215) side by the amount of the increased volume inside the balloon (215), and blood from the blood vessels flows in with it at this time.

[0044] The injection site according to one embodiment will be described with reference to Figure 3. Figure 3 is a schematic diagram showing the injection site according to one embodiment.

[0045] The blood glucose measurement sensor (350) can be positioned adjacent to the injection needle (310) within the insulin supply pathway (P1). As described above, the injection unit according to this embodiment allows a certain volume of blood to flow in the reverse direction (D2), that is, in the opposite direction to the insulin supply direction (D1), so that the blood glucose measurement sensor (350) can come into contact with the blood.

[0046] When using a conventional needle-integrated sensor to simultaneously administer insulin and measure blood glucose, the concentration of insulin per unit volume of blood is higher inside and at the tip of the needle, which can lead to inaccurate blood glucose measurements. Furthermore, prolonged contact with blood can reduce the sensor's efficiency. However, with the needle according to this embodiment, blood is only introduced and brought into contact with the sensor during blood glucose measurement, thus solving these problems.

[0047] A pressure adjustment unit according to one embodiment will be described with reference to Figure 4. Figure 4 is a cross-sectional view showing the pressure adjustment unit according to one embodiment.

[0048] The pressure regulating section (190) can be implemented in various ways. The pressure regulating section (190) according to this embodiment includes a cylinder section (191) and a piston section (193). The cylinder section (191) is formed in a hollow shape, and one side is connected to the pressure regulating path (P2), connecting the space inside the cylinder section (191) (P2-1) to the pressure regulating path (P2).

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

[0050] Refer to Figure 5 to explain the blood glucose measurement and insulin administration process.

[0051] As described above, the control unit receives blood glucose measurements from the blood glucose sensor and blood glucose measurement unit, generates an insulin administration command for blood glucose management, and sends it to the insulin pump. It measures the insulin dosage and the blood glucose change per unit time, and controls the insulin dosage according to the blood glucose management plan based on these measurements.

[0052] Specifically, when negative pressure is created in the negative pressure formation area, the balloon expands, and a certain amount of blood flows into the inside of the injection site. This blood then comes into contact with the blood glucose 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, and the blood is returned to the blood vessel through the injection needle.

[0053] Subsequently, the insulin dosage is adjusted using the measured blood glucose data, and insulin is administered. 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. Subsequently, the blood glucose level in the body is measured periodically, the amount of blood glucose change per unit time is calculated, and the amount of insulin administered can be increased or decreased to adjust the amount of blood glucose change per unit time according to the preset blood glucose adjustment schedule curve.

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

Claims

1. A device for continuous blood glucose monitoring and insulin administration, An insulin supply unit that supplies insulin through an insulin supply tube, A blocking unit that blocks the supply of insulin from the insulin supply unit, A balloon portion is provided in a part of the insulin supply tube and is formed to be expandable in cross-sectional area, A pressure adjustment unit for creating or releasing negative pressure on the outside of the balloon portion, A needle for injecting insulin supplied through the insulin supply tube into the body, An injection unit including a blood glucose measuring sensor located within the insulin supply path formed by the insulin supply tube to measure blood glucose, A blood glucose measurement unit that collects blood glucose measurement data measured from the blood glucose measurement sensor, Control unit and Includes, The control unit, During blood glucose measurement, the pressure adjustment unit is controlled to expand the balloon while the insulin supply from the insulin supply unit is blocked via the blocking unit. The blood glucose sensor is controlled while a certain amount of blood from the body is introduced into the insulin supply pathway through the aforementioned injection needle, and the blood glucose of the incoming blood is measured. A device characterized by the following features.

2. The balloon portion is A balloon made of an elastic material and with an expandable outer diameter is provided in a part of the insulin supply tube, A balloon housing is provided so as to surround the outside of the balloon and forms a negative pressure forming space between itself and the balloon, which is connected to the pressure adjustment section via a pressure adjustment path. The apparatus according to claim 1, including the following:

3. The aforementioned pressure adjustment unit is A cylinder portion formed in a hollow shape, with one side connected to the pressure adjustment path, A piston portion is housed inside the cylinder portion and reciprocates within the cylinder portion to adjust the pressure inside the balloon housing. The apparatus according to claim 2, including the following:

4. The apparatus according to claim 1, wherein the blood glucose measuring sensor is provided in the insulin supply pathway at a position adjacent to the injection needle.

5. The apparatus according to claim 4, wherein the negative pressure causes the incoming blood to flow back to the blood glucose measurement sensor.

6. The apparatus 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 administered to adjust the amount of blood glucose change per unit time based on a preset blood glucose adjustment schedule curve.

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