WO2024010265A1 - Continuous blood sugar measurement and insulin injection apparatus - Google Patents

Continuous blood sugar measurement and insulin injection apparatus Download PDF

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Publication number
WO2024010265A1
WO2024010265A1 PCT/KR2023/008897 KR2023008897W WO2024010265A1 WO 2024010265 A1 WO2024010265 A1 WO 2024010265A1 KR 2023008897 W KR2023008897 W KR 2023008897W WO 2024010265 A1 WO2024010265 A1 WO 2024010265A1
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Prior art keywords
blood sugar
insulin
unit
blood
balloon
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PCT/KR2023/008897
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French (fr)
Korean (ko)
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원영준
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가톨릭관동대학교산학협력단
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Publication of WO2024010265A1 publication Critical patent/WO2024010265A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4836—Diagnosis combined with treatment in closed-loop systems or methods
    • A61B5/4839—Diagnosis combined with treatment in closed-loop systems or methods combined with drug delivery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14503—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150053—Details for enhanced collection of blood or interstitial fluid at the sample site, e.g. by applying compression, heat, vibration, ultrasound, suction or vacuum to tissue; for reduction of pain or discomfort; Skin piercing elements, e.g. blades, needles, lancets or canulas, with adjustable piercing speed
    • A61B5/150061—Means for enhancing collection
    • A61B5/150099—Means for enhancing collection by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/155—Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/157—Devices characterised by integrated means for measuring characteristics of blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31546—Electrically operated dose setting, e.g. input via touch screen or plus/minus buttons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose

Definitions

  • the present invention relates to a continuous blood sugar measurement and insulin injection device.
  • a continuous blood glucose meter is a device developed to enable continuous measurement of blood sugar.
  • invasive methods such as the microneedle method are still more reliable and accurate than non-invasive methods. Since there are individual differences in blood sugar measurement and differences in biological material components (interference effects, etc.), the method of selectively decomposing glucose is a highly sensitive sensor technology that can measure even low blood sugar and is said to be the most reliable.
  • the microneedle-type continuous blood sugar measurement system has the effect of improving user convenience by minimizing the depth of invasion of the sensor, where a body fluid detection type needle is inserted under the skin after being attached to the measurement site.
  • the sensor of a blood sugar measuring device contains enzymes for measuring blood sugar, such as glucose oxidase, and these enzymes contain components (ascorbate) that can be contained in the blood when exposed to the blood for a long time. , urate, acetaminophen, etc.) problems may occur.
  • the present invention provides a device that can easily measure and manage blood sugar in patients who need accurate blood sugar level measurement and continuous blood sugar management, such as in patients with acute hyperglycemia.
  • the continuous blood sugar measurement and insulin injection device includes an insulin supply unit that supplies insulin through an insulin supply tube; a negative pressure forming unit that refluxes the insulin supplied from the insulin supply unit by a certain amount; an injection unit including an injection needle for injecting insulin supplied through the insulin supply tube into the body, and a blood sugar measurement sensor located within the insulin supply path formed by the insulin supply tube to measure blood sugar; a blood sugar measurement unit that collects blood sugar measurement data measured from the blood sugar measurement sensor; and a control unit that controls the negative pressure generator to control the blood glucose measurement sensor to control the blood glucose measurement sensor to allow a certain amount of blood to flow into the body through the injection needle to measure the blood sugar level of the introduced blood when measuring blood sugar.
  • the negative pressure forming unit includes a blocking unit that blocks the supply of insulin from the insulin supply unit; a balloon portion formed to expand the cross-sectional area of one point of the insulin supply tube; And a pressure regulator that creates negative pressure or removes negative pressure on the outside of the balloon portion,
  • the control unit may control the pressure control unit to expand the balloon unit while blocking the supply of insulin through the blocking unit, thereby allowing a certain amount of blood to flow through the injection needle.
  • the balloon portion may include a balloon formed of an elastic material at one point of the insulin supply tube so that the outer diameter is expandable; and a balloon housing provided to surround the outside of the balloon and forming a negative pressure forming space between the balloon and the balloon and connected to the pressure control flow path to the pressure control unit.
  • the pressure control unit includes a cylinder part formed in a hollow shape and one side of which is connected to the pressure control passage; and a piston unit accommodated within the cylinder unit and reciprocating within the cylinder unit to adjust the pressure within the balloon housing.
  • the blood sugar measurement sensor may be provided at a location adjacent to the injection needle in the insulin supply path.
  • the negative pressure forming unit may cause the introduced blood to flow back to the blood sugar measurement sensor.
  • control unit calculates the change in blood sugar per unit time from the blood sugar measurement data transmitted from the blood sugar measurement unit, and increases or decreases the amount of insulin administered to control the change in blood sugar per unit time according to a preset blood sugar control schedule curve. .
  • the present invention it is possible to inject insulin and measure blood sugar in patients with acute hyperglycemia in an emergency room or intensive care unit using a single needle, thus reducing the inconvenience of having to stick a needle into the body every time blood sugar is measured. You can.
  • Figure 1 is a block diagram showing a blood sugar measurement and insulin injection device according to an embodiment of the present invention.
  • Figure 2 is a schematic diagram showing a balloon unit according to one embodiment.
  • Figure 3 is a schematic diagram showing the appearance of a scanning unit according to one embodiment.
  • Figure 4 is a cross-sectional view showing the pressure regulator according to one embodiment.
  • the continuous blood sugar measurement and insulin injection device includes an insulin supply unit that supplies insulin through an insulin supply tube; a negative pressure forming unit that refluxes the insulin supplied from the insulin supply unit by a certain amount; an injection unit including an injection needle for injecting insulin supplied through the insulin supply tube into the body, and a blood sugar measurement sensor located within the insulin supply path formed by the insulin supply tube to measure blood sugar; a blood sugar measurement unit that collects blood sugar measurement data measured from the blood sugar measurement sensor; and a control unit that controls the negative pressure generator to control the blood glucose measurement sensor to control the blood glucose measurement sensor to allow a certain amount of blood to flow into the body through the injection needle to measure the blood sugar level of the introduced blood when measuring blood sugar.
  • FIG. 1 is a block diagram showing a blood sugar measurement and insulin injection device according to an embodiment of the present invention.
  • the blood sugar measurement and insulin injection device is a device that simultaneously performs blood sugar measurement and insulin injection through a single invasive structure, and each component will be described in detail below.
  • the insulin supply device 100 includes a control unit 110, a blood sugar measurement unit 120, a negative pressure forming unit 140, 190, 200, an insulin supply unit 130, and a blood sugar measurement sensor. Includes an injection unit 300.
  • the negative pressure forming unit may be implemented as a blocking unit 140, a pressure adjusting unit 190, and a balloon unit 200, as examples.
  • the insulin supply unit 130 supplies insulin through the insulin supply tube forming the insulin supply passage (P1).
  • the insulin supply unit 130 under the control of the control unit 110 has the same configuration as that of an existing insulin pump.
  • the negative pressure forming unit (140, 190, 200) is a component that causes the insulin supplied from the insulin supply unit (130) to flow back by a certain amount in the insulin supply passage (P1).
  • the negative pressure forming unit can be implemented in various ways, such as a two-way drive pump, as long as it forms negative pressure and allows a certain amount of blood to flow into the body through the insulin supply channel.
  • the negative pressure forming unit includes a blocking unit 140, a pressure adjusting unit 190, and a balloon unit 200 in detail.
  • 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 point of the insulin supply channel (P1) and prevents insulin from flowing back from the insulin supply channel (P1) to the insulin supply unit 130.
  • the balloon portion 200 is formed to expand the cross-sectional area of one point of the insulin supply tube.
  • the balloon portion 200 functions to temporarily increase the amount of insulin at a point in the insulin supply channel by expanding the cross-sectional area at that point. Accordingly, a certain amount of insulin and blood flows in the reverse direction from the injection unit 300 based on the corresponding point.
  • the pressure control unit 190 operates to expand the outer diameter of the balloon part 200 by forming negative pressure on the outside of the balloon part 200 or to return the outer diameter of the balloon part 200 to its original state by removing the negative pressure.
  • the injection unit 300 is a component for injecting insulin supplied through an insulin supply tube into the body and simultaneously measuring blood sugar, and is equipped with an injection needle 310 and a blood sugar measurement sensor 350.
  • the injection needle 310 is a component that invasively flows into the body's blood vessels, and the blood sugar measurement sensor 350 is located within the insulin supply path (P1) formed by the insulin supply tube and measures blood sugar.
  • Existing invasive blood sugar measurement sensors such as the needle-type blood sugar measurement sensor disclosed in Republic of Korea Patent Publication No. 10-2019-0025208 (hereinafter referred to as 'Prior Art 1'), are provided on a needle and detect blood in the blood when exposed to blood. It was implemented as a type that measures glucose concentration.
  • 'Prior Art 1' are provided on a needle and detect blood in the blood when exposed to blood. It was implemented as a type that measures glucose concentration.
  • amperometric glucose is used.
  • a biosensor Amperometic Glucose biosensor
  • it is provided with a sensor electrode configured to immobilize an enzyme for measuring blood sugar, such as glucose oxidase, between porous sensor electrodes.
  • these electrodes contain ascorbate and urine that may be contained in the body's blood. Sensing efficiency may decrease due to reaction when exposed to acid or acetaminophen for a long time.
  • a sensor for measuring blood sugar is embedded within the injection needle, so that the thickness of the injection needle itself is thicker than that of a needle for general insulin administration, thereby reducing the patient's discomfort when inserting the needle into the human body. It can cause
  • the injection unit 300 does not need to be equipped with a blood sugar measurement sensor that can be exposed to the end of the injection needle or blood in order to measure blood sugar
  • the injection needle 310 can be used for general injection for insulin administration. It can be formed according to the thickness of the needle.
  • the blood sugar measurement unit 120 collects blood sugar measurement data measured from the blood sugar measurement sensor 350.
  • control unit 110 controls the negative pressure forming units 140, 190, and 200 to control the blood sugar measurement unit 120 and the blood sugar measurement sensor 350 while allowing a certain amount of blood into the body through the injection needle 310. Control and measure the blood sugar level of the inflow blood.
  • control unit 110 calculates the change in blood sugar per unit time from the blood sugar measurement data transmitted from the blood sugar measurement unit 120, and increases or decreases the amount of insulin administered to control the change in blood sugar per unit time according to a preset blood sugar control schedule curve. You can.
  • control unit 110 can be provided as a separate computing system or a smartphone application and connected to each component of the insulin supply device 100 using a communication means such as a Wifi module.
  • FIG. 2 is a schematic diagram showing a balloon unit according to one embodiment.
  • the balloon unit 200 includes a balloon 215 and a balloon housing 225.
  • the balloon 215 is formed of an elastic material at one point of the insulin supply tube 210 so that its outer diameter can be expanded.
  • the balloon housing 225 is provided to surround the outside of the balloon 215, and is connected to the above-described pressure regulator with the pressure regulator pipe 220 between the balloon 215 and the balloon housing 225.
  • the pressure control pipe 220 forms a pressure control flow path (P2) between the pressure control unit and the balloon housing 225.
  • the pressure control tube 220 may be formed integrally with the outside of the insulin supply tube 210, or may be formed as a separate tube.
  • the balloon housing 225 forms a negative pressure forming space between the balloon housing 215 and the balloon housing 225 .
  • negative pressure is formed through the pressure control passage (P2)
  • the balloon 215 expands inside the balloon housing 225.
  • the insulin present inside the injection unit moves from the injection unit side to the balloon 215 side by the increased capacity inside the balloon 215. And at this time, blood within the blood vessels flows in together.
  • FIG. 3 is a schematic diagram showing the appearance of a scanning unit according to one embodiment.
  • the blood sugar measurement sensor 350 may be installed at a location adjacent to the injection needle 310 in the insulin supply path (P1). As described above, the injection unit according to this embodiment allows blood to come into contact with the blood sugar measurement sensor 350 by flowing a certain amount of blood in the reverse direction (D2), that is, in the direction opposite to the insulin supply direction (D1).
  • FIG. 4 is a cross-sectional view showing the pressure regulator according to one embodiment.
  • the pressure control unit 190 can be implemented in various ways.
  • the pressure adjusting unit 190 according to this embodiment includes a cylinder unit 191 and a piston unit 193.
  • the cylinder unit 191 is formed in a hollow shape and one side is connected to the pressure control flow path (P2) to connect the space (P2-1) inside the cylinder part 191 and the pressure control flow path (P2).
  • the piston unit 193 is accommodated inside the cylinder unit 191 and reciprocates within the cylinder unit 191 to adjust the pressure within the balloon housing described above.
  • control unit receives blood sugar measurement values from the blood sugar measurement sensor and blood sugar measurement unit, generates an insulin injection command for blood sugar management, and transmits it to the insulin pump. Insulin dosage and blood sugar change per unit time are measured and the insulin dosage is controlled according to the blood sugar management plan.
  • the balloon expands, a certain amount of blood flows into the injection part, and blood sugar is measured while the blood comes into contact with the blood sugar measurement sensor located inside. After measuring blood sugar, the negative pressure is dismantled and the balloon returns to its original state, and the blood is again injected into the blood vessel through the needle.
  • the insulin injection amount is adjusted using the measured blood sugar data and insulin is administered.
  • the control unit sets the target blood sugar level according to the measured blood sugar data and sets a blood sugar control schedule graph as shown in FIG. 5 to control blood sugar to the target blood sugar level.
  • the blood sugar level in the body is periodically measured to calculate the change in blood sugar per unit time, and the amount of insulin administered can be increased or decreased to control the change in blood sugar per unit time according to a preset blood sugar control schedule curve.

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Abstract

A continuous blood sugar measurement and insulin injection apparatus according to the present invention comprises: an insulin supply unit which supplies insulin through an insulin supply tube; a negative pressure formation unit which refluxes the insulin supplied from the insulin supply unit by a certain amount; an injection unit including an injection needle for injecting the insulin supplied through the insulin supply tube into the body, and a blood sugar measurement sensor which is located within an insulin supply path formed by the insulin supply tube and measures blood sugar; a blood sugar measurement unit which collects blood sugar measurement data measured by the blood sugar measurement sensor; and a control unit which, during blood sugar measurement, controls the blood sugar measurement sensor in a state in which a certain amount of blood in the body has been introduced through the injection needle by controlling the negative pressure formation unit, and thereby measures the blood sugar in the introduced blood.

Description

연속혈당 측정 및 인슐린 투입장치Continuous blood sugar measurement and insulin injection device
본 발명은 연속혈당 측정 및 인슐린 투입장치에 관한 것이다.The present invention relates to a continuous blood sugar measurement and insulin injection device.
과거에는 손끝에서 피를 내서 혈당을 측정했다. 이 방식은 채혈로 인해 통증이 동반되고 1시간에 한번씩만 측정한다고 해도 혈당 흐름을 측정 간격 동안에는 알 수 없는 문제가 있었다.In the past, blood sugar levels were measured by drawing blood from the fingertip. This method had the problem of causing pain due to blood collection and not being able to determine the blood sugar flow during the measurement interval, even if it was measured only once an hour.
연속식 혈당 측정기는 연속적인 혈당의 측정이 가능하도록 개발된 장치이다. 다만, 혈당 측정 방식 중 아직까지는 비침습적 방식에 비하여 신뢰성 및 정확도가 높은 방식은 마이크로 니들 방식 등 침습적 방식이라 할 수 있다. 혈당 측정시 개인별 편차 및 생체물질의 구성 성분(간섭영향 등)의 차이가 있기 때문에 선택적으로 포도당을 분해하는 방식이 저혈당까지 측정할 수 있는 고감도 센서 기술이면서 가장 신뢰성이 높다고 할 수 있다. 다만, 손가락 끝에서 채혈기를 이용하여 통증이 동반되는 채 혈 방식으로 일정량의 모세혈을 측정기와 결합된 검사지에 주입함으로서 측정하는 복잡한 측정 단계로 이루어져 있는 시스템 보다는 채혈 고통 및 통증에서 벗어나 측정할 수 있는 방식 중 하나인 마이크로 니들 방식의 연속혈당 측정 시스템은 측정부위에 부착한 후에 체액 탐지형의 니들이 피하에 삽입되는 센서의 침습 깊이를 최소화하는 등 사용자의 편의성을 증진시키는 효과가 있다.A continuous blood glucose meter is a device developed to enable continuous measurement of blood sugar. However, among blood sugar measurement methods, invasive methods such as the microneedle method are still more reliable and accurate than non-invasive methods. Since there are individual differences in blood sugar measurement and differences in biological material components (interference effects, etc.), the method of selectively decomposing glucose is a highly sensitive sensor technology that can measure even low blood sugar and is said to be the most reliable. However, rather than a system that consists of complex measurement steps in which a certain amount of capillary blood is measured by injecting a certain amount of capillary blood into a test strip combined with a measuring device through a painful blood collection method using a blood collection device at the tip of the finger, it is possible to measure without the pain and pain of blood collection. One of the methods, the microneedle-type continuous blood sugar measurement system, has the effect of improving user convenience by minimizing the depth of invasion of the sensor, where a body fluid detection type needle is inserted under the skin after being attached to the measurement site.
그러나, 급성 고혈당 환자 등 응급실이나 중환자실에서 연속적이고도 정확한 혈당의 관리가 필요한 경우에는 피하지방이나 간질액으로부터 포도당의 농도를 측정하는 것은 혈액에 비하여 시간차에 따른 오차나 환경에 따른 오차가 발생할 수 있기 때문에 문제가 될 수 있다.However, in cases where continuous and accurate blood sugar management is required in the emergency room or intensive care unit, such as in patients with acute hyperglycemia, measuring glucose concentration from subcutaneous fat or interstitial fluid may result in errors due to time difference or environment compared to blood. Because of this, it can be a problem.
따라서 여전히 중환자실 등에서는 직접 채혈과 이에 기초하여 의사의 판단에 따른 인슐린의 투약이 반복적으로 이루어짐으로써 환자와 의사의 불편함이 여전히 따르게 된다.Therefore, in intensive care units, direct blood collection and insulin administration based on the doctor's judgment are repeatedly performed, causing inconvenience to patients and doctors.
또한 기존의 연속혈당 측정장치와 인슐린 펌프를 별도로 구비하여 이용하는 경우에도 개별적인 바늘을 이용하여야 함으로써 채혈과 인슐린의 투여에 별도의 주사 바늘을 이용하여야 하는 문제가 있으며, 기존의 장치들을 이용하여 하나의 주사 바늘을 통하여 혈당의 측정과 인슐린의 투여가 가능하다고 해도 혈당 측정장치의 센서는 글루코오스 옥시다아제와 같은 혈당 측정을 위한 효소가 포함되어 있으며 이러한 효소는 혈액 중에 장시간 노출됨으로써 혈액 중 포함될 수 있는 성분(아스코르브산염, 요산염, 아세트아미노펜 등)에 반응하는 문제가 발생할 수 있다.In addition, even when using an existing continuous blood sugar measurement device and an insulin pump separately, there is a problem in that separate needles must be used for blood collection and insulin administration, and a single injection is possible using existing devices. Even though it is possible to measure blood sugar and administer insulin through a needle, the sensor of a blood sugar measuring device contains enzymes for measuring blood sugar, such as glucose oxidase, and these enzymes contain components (ascorbate) that can be contained in the blood when exposed to the blood for a long time. , urate, acetaminophen, etc.) problems may occur.
또한 이러한 효소와 혈액간의 반응 문제가 없는 경우라도 인슐린 투입과 혈당 측정을 동시에 수행하는 경우 바늘 내부 및 바늘의 첨단부에서는 단위 부피 당 순수 혈액에 비하여 인슐린이 혼합되어 있기 때문에 혈당의 측정이 정확히 이루어지지 않는 문제가 발생할 수 있다.In addition, even in cases where there is no reaction problem between these enzymes and blood, when insulin injection and blood sugar measurement are performed simultaneously, blood sugar measurement cannot be accurately performed because insulin is mixed inside the needle and at the tip of the needle compared to pure blood per unit volume. Problems may arise.
본 발명은 급성 고혈당 환자 등 정확한 혈당치의 측정이 필요하면서 동시에 이에 대한 연속적인 혈당의 관리가 필요한 상태에서 용이하게 혈당의 측정 및 관리를 수행할 수 있는 장치를 제공한다.The present invention provides a device that can easily measure and manage blood sugar in patients who need accurate blood sugar level measurement and continuous blood sugar management, such as in patients with acute hyperglycemia.
본 발명에 따른 연속혈당 측정 및 인슐린 투입장치는 인슐린 공급튜브를 통하여 인슐린을 공급하는 인슐린 공급부; 상기 인슐린 공급부로부터 공급되는 인슐린을 일정량만큼 역류시키는 음압형성부; 상기 인슐린 공급튜브를 통하여 공급되는 인슐린을 체내에 주입하는 주사 바늘과, 상기 인슐린 공급튜브가 형성하는 인슐린 공급경로 내에 위치하여 혈당을 측정하는 혈당측정 센서를 포함하는 주사부; 상기 혈당측정 센서로부터 측정된 혈당 측정 데이터를 수집하는 혈당 측정부; 및 혈당 측정 시 상기 음압형성부를 제어하여 주사 바늘을 통하여 체내 혈액을 일정량 유입시킨 상태에서 상기 혈당측정 센서를 제어하여 상기 유입된 혈액의 혈당을 측정하는 제어부;를 포함한다.The continuous blood sugar measurement and insulin injection 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 refluxes the insulin supplied from the insulin supply unit by a certain amount; an injection unit including an injection needle for injecting insulin supplied through the insulin supply tube into the body, and a blood sugar measurement sensor located within the insulin supply path formed by the insulin supply tube to measure blood sugar; a blood sugar measurement unit that collects blood sugar measurement data measured from the blood sugar measurement sensor; and a control unit that controls the negative pressure generator to control the blood glucose measurement sensor to control the blood glucose measurement sensor to allow a certain amount of blood to flow into the body through the injection needle to measure the blood sugar level of the introduced blood when measuring blood sugar.
또한 상기 음압형성부는, 상기 인슐린 공급부로부터의 인슐린 공급을 차단하는 차단부; 상기 인슐린 공급튜브 중 일 지점의 단면적을 확장가능하도록 형성되는 벌룬부; 및 상기 벌룬부의 외측에 음압을 형성하거나 음압을 제거하는 압력조절부;를 포함하고,In addition, the negative pressure forming unit includes a blocking unit that blocks the supply of insulin from the insulin supply unit; a balloon portion formed to expand the cross-sectional area of one point of the insulin supply tube; And a pressure regulator that creates negative pressure or removes negative pressure on the outside of the balloon portion,
상기 제어부는 상기 차단부를 통하여 인슐린 공급을 차단한 상태에서 상기 압력조절부를 제어하여 상기 벌룬부를 확장시켜서 상기 주사 바늘을 통하여 혈액을 일정량 유입시킬 수 있다.The control unit may control the pressure control unit to expand the balloon unit while blocking the supply of insulin through the blocking unit, thereby allowing a certain amount of blood to flow through the injection needle.
또한 상기 벌룬부는, 상기 인슐린 공급튜브의 일 지점에 탄성재질로 형성되어 외경이 확장가능하도록 형성되는 벌룬; 및 상기 벌룬의 외곽을 둘러싸도록 구비되고, 상기 벌룬과의 사이에 상기 압력조절부에 압력조절 유로로 연결되는 음압 형성 공간을 형성하는 벌룬 하우징;을 포함할 수 있다.In addition, the balloon portion may include a balloon formed of an elastic material at one point of the insulin supply tube so that the outer diameter is expandable; and a balloon housing provided to surround the outside of the balloon and forming a negative pressure forming space between the balloon and the balloon and connected to the pressure control flow path to the pressure control unit.
또한 상기 압력조절부는, 중공의 형상으로 형성되고 일측이 상기 압력조절 유로에 연결되는 실린더부; 및 상기 실린더부 내부에 수용되고, 상기 실린더부 내에서 왕복하여 상기 벌룬 하우징 내의 압력을 조절하는 피스톤부;를 포함할 수 있다.In addition, the pressure control unit includes a cylinder part formed in a hollow shape and one side of which is connected to the pressure control passage; and a piston unit accommodated within the cylinder unit and reciprocating within the cylinder unit to adjust the pressure within the balloon housing.
또한 상기 혈당측정 센서는 상기 인슐린 공급 경로 중 상기 주사 바늘에 인접한 위치에 구비될 수 있다.Additionally, the blood sugar measurement sensor may be provided at a location adjacent to the injection needle in the insulin supply path.
또한 상기 음압형성부는 상기 유입된 혈액이 상기 혈당측정 센서까지 유입되도록 역류시킬 수 있다.Additionally, the negative pressure forming unit may cause the introduced blood to flow back to the blood sugar measurement sensor.
또한 상기 제어부는 상기 혈당 측정부로부터 전달된 혈당 측정 데이터로부터 단위 시간당 혈당 변화량을 산출하고, 기 설정된 혈당 조절 스케쥴곡선에 따라 상기 단위 시간당 혈당 변화량을 조절하도록 투여되는 상기 인슐린의 양을 증감시킬 수 있다.In addition, the control unit calculates the change in blood sugar per unit time from the blood sugar measurement data transmitted from the blood sugar measurement unit, and increases or decreases the amount of insulin administered to control the change in blood sugar per unit time according to a preset blood sugar control schedule curve. .
본 발명에 따르면 응급실이나 중환자실 등에서 급성 고혈당인 환자에게 인슐린의 주입과 혈당의 측정을 하나의 바늘을 이용하여 수행할 수 있도록 함으로써 혈당의 측정 시마다 주사 바늘을 인체에 찔러야 하는 등의 불편함을 줄일 수 있다.According to the present invention, it is possible to inject insulin and measure blood sugar in patients with acute hyperglycemia in an emergency room or intensive care unit using a single needle, thus reducing the inconvenience of having to stick a needle into the body every time blood sugar is measured. You can.
또한 센서의 전극이 장시간 혈액에 노출됨으로써 혈액과 반응하는 것을 방지할 수 있는 효과가 있으며, 급성 고혈당 환자 들의 연속적이면서도 정확한 혈당의 측정과 혈당의 관리가 하나의 장치로 가능하도록 함으로써 편의성이 증대된다.In addition, it has the effect of preventing the sensor electrode from reacting with blood due to exposure to blood for a long period of time, and convenience is increased by enabling continuous and accurate blood sugar measurement and blood sugar management in patients with acute hyperglycemia with a single device.
도 1은 본 발명의 일 실시예에 따른 혈당 측정 및 인슐린 투입장치을 나타내는 블록도이다.Figure 1 is a block diagram showing a blood sugar measurement and insulin injection device according to an embodiment of the present invention.
도 2는 일 실시예에 따른 벌룬부를 나타내는 개략도이다.Figure 2 is a schematic diagram showing a balloon unit according to one embodiment.
도 3은 일 실시예에 따른 주사부의 모습을 나타내는 개략도이다.Figure 3 is a schematic diagram showing the appearance of a scanning unit according to one embodiment.
도 4는 일 실시예에 따른 압력조절부의 모습을 나타는 단면도이다.Figure 4 is a cross-sectional view showing the pressure regulator according to one embodiment.
본 발명에 따른 연속혈당 측정 및 인슐린 투입장치는 인슐린 공급튜브를 통하여 인슐린을 공급하는 인슐린 공급부; 상기 인슐린 공급부로부터 공급되는 인슐린을 일정량만큼 역류시키는 음압형성부; 상기 인슐린 공급튜브를 통하여 공급되는 인슐린을 체내에 주입하는 주사 바늘과, 상기 인슐린 공급튜브가 형성하는 인슐린 공급경로 내에 위치하여 혈당을 측정하는 혈당측정 센서를 포함하는 주사부; 상기 혈당측정 센서로부터 측정된 혈당 측정 데이터를 수집하는 혈당 측정부; 및 혈당 측정 시 상기 음압형성부를 제어하여 주사 바늘을 통하여 체내 혈액을 일정량 유입시킨 상태에서 상기 혈당측정 센서를 제어하여 상기 유입된 혈액의 혈당을 측정하는 제어부;를 포함한다.The continuous blood sugar measurement and insulin injection 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 refluxes the insulin supplied from the insulin supply unit by a certain amount; an injection unit including an injection needle for injecting insulin supplied through the insulin supply tube into the body, and a blood sugar measurement sensor located within the insulin supply path formed by the insulin supply tube to measure blood sugar; a blood sugar measurement unit that collects blood sugar measurement data measured from the blood sugar measurement sensor; and a control unit that controls the negative pressure generator to control the blood glucose measurement sensor to control the blood glucose measurement sensor to allow a certain amount of blood to flow into the body through the injection needle to measure the blood sugar level of the introduced blood when measuring blood sugar.
이하 첨부된 도면을 참조하여 본 발명의 실시예를 설명한다. 특별한 정의나 언급이 없는 경우에 본 설명에 사용하는 방향을 표시하는 용어는 도면에 표시된 상태를 기준으로 한다. 또한 각 실시예를 통하여 동일한 도면부호는 동일한 부재를 가리킨다. 한편, 도면상에서 표시되는 각 구성은 설명의 편의를 위하여 그 두께나 치수가 과장될 수 있으며, 실제로 해당 치수나 구성간의 비율로 구성되어야 함을 의미하지는 않는다.Hereinafter, embodiments of the present invention will be described with reference to the attached drawings. Unless otherwise specified or specified, terms indicating direction used in this description are based on the state shown in the drawings. Additionally, the same reference numerals refer to the same members throughout each embodiment. Meanwhile, the thickness or dimensions of each configuration shown in the drawings may be exaggerated for convenience of explanation, and this does not mean that they should actually be composed of the ratios between the corresponding dimensions or configurations.
도 1을 참조하여 본 발명의 일 실시예에 따른 혈당 측정 및 인슐린 투입장치를 설명한다. 도 1은 본 발명의 일 실시예에 따른 혈당 측정 및 인슐린 투입장치을 나타내는 블록도이다.A blood sugar measurement and insulin injection device according to an embodiment of the present invention will be described with reference to FIG. 1. Figure 1 is a block diagram showing a blood sugar measurement and insulin injection device according to an embodiment of the present invention.
본 발명에 따른 혈당 측정 및 인슐린 투입 장치는 하나의 침습적 구성을 통하여 혈당의 측정과 인슐린의 투입을 동시에 수행하는 장치로서 이하 각 구성부에 대하여 구체적으로 설명한다.The blood sugar measurement and insulin injection device according to the present invention is a device that simultaneously performs blood sugar measurement and insulin injection through a single invasive structure, and each component will be described in detail below.
본 발명의 일 실시예에 따른 인슐린 공급장치(100)는 제어부(110), 혈당측정부(120), 음압형성부(140, 190, 200), 인슐린 공급부(130) 및 혈당측정센서를 구비한 주사부(300)를 포함한다. 이 중 음압형성부는 일 예로서 차단부(140), 압력조절부(190) 및 벌룬부(200)로 구현될 수 있다.The insulin supply device 100 according to an embodiment of the present invention includes a control unit 110, a blood sugar measurement unit 120, a negative pressure forming unit 140, 190, 200, an insulin supply unit 130, and a blood sugar measurement sensor. Includes an injection unit 300. Among these, the negative pressure forming unit may be implemented as a blocking unit 140, a pressure adjusting unit 190, and a balloon unit 200, as examples.
구체적으로 인슐린 공급부(130)는 인슐린 공급유로(P1)를 형성하는 인슐린 공급튜브를 통하여 인슐린을 공급한다. 제어부(110)의 제어에 따른 인슐린 공급부(130)는 기존의 인슐린 펌프의 구성과 대동소이하다.Specifically, the insulin supply unit 130 supplies insulin through the insulin supply tube forming the insulin supply passage (P1). The insulin supply unit 130 under the control of the control unit 110 has the same configuration as that of an existing insulin pump.
음압형성부(140. 190, 200)는 인슐린 공급부(130)로부터 공급되는 인슐린을 인슐린 공급유로(P1)에서 일정량만큼 역류시키기 위한 구성부이다. 음압형성부는 음압을 형성하여 인슐린 공급 유로를 통하여 체내의 혈액을 일정량 유입시키는 구성이라면 양방향 구동 펌프 등과 같이 다양하게 구현할 수 있다.The negative pressure forming unit (140, 190, 200) is a component that causes the insulin supplied from the insulin supply unit (130) to flow back by a certain amount in the insulin supply passage (P1). The negative pressure forming unit can be implemented in various ways, such as a two-way drive pump, as long as it forms negative pressure and allows a certain amount of blood to flow into the body through the insulin supply channel.
본 실시예에 따른 음압형성부는 세부적으로 차단부(140), 압력조절부(190) 및 벌룬부(200)를 포함한다. 차단부(140)는 인슐린 공급부(130)로부터의 인슐린 공급을 차단한다. 차단부(140)는 인슐린 공급유로(P1)의 일 지점을 차단하는 방식으로 인슐린의 공급을 차단하고 인슐린 공급유로(P1)로부터 인슐린이 인슐린 공급부(130)로 역류하는 것을 방지한다.The negative pressure forming unit according to this embodiment includes a blocking unit 140, a pressure adjusting unit 190, and a balloon unit 200 in detail. 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 point of the insulin supply channel (P1) and prevents insulin from flowing back from the insulin supply channel (P1) to the insulin supply unit 130.
벌룬부(200)는 인슐린 공급튜브 중 일 지점의 단면적을 확장가능하도록 형성된다. 벌룬부(200)는 인슐린 공급유로 중 일 지점의 단면적을 확장시킴으로써 해당 지점에서의 인슐린 양을 일시적으로 증가시키는 기능을 한다. 따라서 해당 일 지점을 기준으로 주사부(300) 측으로부터 일정량의 인슐린 및 혈액이 역방향으로 유입된다.The balloon portion 200 is formed to expand the cross-sectional area of one point of the insulin supply tube. The balloon portion 200 functions to temporarily increase the amount of insulin at a point in the insulin supply channel by expanding the cross-sectional area at that point. Accordingly, a certain amount of insulin and blood flows in the reverse direction from the injection unit 300 based on the corresponding point.
압력조절부(190)는 벌룬부(200)의 외측에 음압을 형성하여 벌룬부(200)의 외경을 확장시키거나 음압을 제거하여 벌룬부(200)의 외경을 원래대로 되돌리도록 작동한다. The pressure control unit 190 operates to expand the outer diameter of the balloon part 200 by forming negative pressure on the outside of the balloon part 200 or to return the outer diameter of the balloon part 200 to its original state by removing the negative pressure.
주사부(300)는 인슐린 공급튜브를 통하여 공급되는 인슐린을 체내에 주입하고 동시에 혈당을 측정하기 위한 구성부로서, 주사바늘(310)과 혈당측정 센서(350)을 구비한다.The injection unit 300 is a component for injecting insulin supplied through an insulin supply tube into the body and simultaneously measuring blood sugar, and is equipped with an injection needle 310 and a blood sugar measurement sensor 350.
주사바늘(310)은 침습적으로 체내 혈관까지 유입되는 구성부이고, 혈당측정센서(350)는 인슐린 공급튜브가 형성하는 인슐린 공급경로(P1) 내에 위치하여 혈당을 측정한다. 기존의 침습적 혈당측정센서는 대한민국 공개특허 제10-2019-0025208호(이하 '선행기술 1'이라 함)에 개시된 바늘 타입의 혈당측정센서 등과 같이 주사바늘에 구비되어 혈액에 노출된 상태에서 혈액 중의 포도당 농도를 측정하는 타입으로 구현되었다. 그러나 이와 같은 센서를 이용하여 혈당의 측정과 인슐린의 체내 주입을 동시에 수행하고자 하는 경우에는 측정 대상인 유체에 혈액뿐만 아니라 인슐린이 혼합됨으로써 정확한 혈당의 측정이 어려울 뿐 아니라 위와 같이 센서의 경우 암페로메트릭 글루코스 바이오 센서((Amperometic Glucose biosensor)의 일 예로서 다공성 센서 전극 사이에 글루코오스 옥시다아제와 같은 혈당 측정을 위한 효소가 고정되도록 구성된 센서 전극을 구비한다. 그러나 이러한 전극은 체내 혈액에 포함될 수 있는 아스코르브산염, 요산염 또는 아세트아미노펜 등에 장시간 노출 시 반응하여 센싱 효율이 저하될 수 있다.The injection needle 310 is a component that invasively flows into the body's blood vessels, and the blood sugar measurement sensor 350 is located within the insulin supply path (P1) formed by the insulin supply tube and measures blood sugar. Existing invasive blood sugar measurement sensors, such as the needle-type blood sugar measurement sensor disclosed in Republic of Korea Patent Publication No. 10-2019-0025208 (hereinafter referred to as 'Prior Art 1'), are provided on a needle and detect blood in the blood when exposed to blood. It was implemented as a type that measures glucose concentration. However, when attempting to measure blood sugar and inject insulin into the body at the same time using such a sensor, not only blood but also insulin are mixed in the fluid to be measured, making it difficult to accurately measure blood sugar. In addition, in the case of the sensor as above, amperometric glucose is used. As an example of a biosensor (Amperometic Glucose biosensor), it is provided with a sensor electrode configured to immobilize an enzyme for measuring blood sugar, such as glucose oxidase, between porous sensor electrodes. However, these electrodes contain ascorbate and urine that may be contained in the body's blood. Sensing efficiency may decrease due to reaction when exposed to acid or acetaminophen for a long time.
또한 상술한 선행기술 1의 경우 주사 바늘 내에 혈당측정을 위한 센서를 내장함으로써 주사 바늘 자체의 굵기가 일반적인 인슐린 투약을 위한 주사바늘에 비하여 굵게 형성됨으로써 인체 내에 바늘을 삽입하는 때에 해당 환자의 불편함을 유발할 수 있다.In addition, in the case of the above-mentioned prior art 1, a sensor for measuring blood sugar is embedded within the injection needle, so that the thickness of the injection needle itself is thicker than that of a needle for general insulin administration, thereby reducing the patient's discomfort when inserting the needle into the human body. It can cause
다만, 본 실시예에 따른 주사부(300)는 혈당을 측정하기 위하여 혈당측정 센서를 주사바늘의 단부나 혈액에 노출가능하도록 구비할 필요없기 떄문에 주사바늘(310)을 일반적인 인슐린 투약을 위한 주사바늘의 굵기로 형성할 수 있다.However, since the injection unit 300 according to this embodiment does not need to be equipped with a blood sugar measurement sensor that can be exposed to the end of the injection needle or blood in order to measure blood sugar, the injection needle 310 can be used for general injection for insulin administration. It can be formed according to the thickness of the needle.
혈당 측정부(120)는 혈당측정 센서(350)로부터 측정된 혈당 측정 데이터를 수집한다.The blood sugar measurement unit 120 collects blood sugar measurement data measured from the blood sugar measurement sensor 350.
제어부(110)는 혈당 측정 시 음압형성부(140, 190, 200)를 제어하여 주사 바늘(310)을 통하여 체내 혈액을 일정량 유입시킨 상태에서 혈당측정부(120) 및 혈당측정 센서(350)를 제어하여 유입된 혈액의 혈당을 측정한다.When measuring blood sugar, the control unit 110 controls the negative pressure forming units 140, 190, and 200 to control the blood sugar measurement unit 120 and the blood sugar measurement sensor 350 while allowing a certain amount of blood into the body through the injection needle 310. Control and measure the blood sugar level of the inflow blood.
또한 제어부(110)는 혈당 측정부(120)로부터 전달된 혈당 측정 데이터로부터 단위 시간당 혈당 변화량을 산출하고, 기 설정된 혈당 조절 스케쥴곡선에 따라 단위 시간당 혈당 변화량을 조절하도록 투여되는 인슐린의 양을 증감시킬 수 있다.In addition, the control unit 110 calculates the change in blood sugar per unit time from the blood sugar measurement data transmitted from the blood sugar measurement unit 120, and increases or decreases the amount of insulin administered to control the change in blood sugar per unit time according to a preset blood sugar control schedule curve. You can.
한편, 제어부(110)는 별도의 컴퓨팅 시스템 또는 스마트폰의 어플리케이션 등으로 구비되어 Wifi 모듈 등의 통신수단을 이용하여 인슐린 공급장치(100)의 각 구성부들과 연결되는 것도 가능하다.Meanwhile, the control unit 110 can be provided as a separate computing system or a smartphone application and connected to each component of the insulin supply device 100 using a communication means such as a Wifi module.
이하에서는 각 구성부의 실시예들에 대하여 구체적으로 설명한다.Hereinafter, embodiments of each component will be described in detail.
도 2를 참조하여 일 실시예에 따른 벌룬부를 구체적으로 설명한다. 도 2는 일 실시예에 따른 벌룬부를 나타내는 개략도이다.The balloon unit according to one embodiment will be described in detail with reference to FIG. 2. Figure 2 is a schematic diagram showing a balloon unit according to one embodiment.
벌룬부(200)는 벌룬(215) 및 벌룬 하우징(225)를 포함한다. 벌룬(215)은 인슐린 공급튜브(210)의 일 지점에 탄성재질로 형성되어 외경이 확장 가능하도록 형성된다. 벌룬 하우징(225)은 벌룬(215)의 외곽을 둘러싸도록 구비되고, 벌룬(215)과의 사이에 상술한 압력조절부에 압력조절관(220)으로 연결된다. 압력조절관(220)은 압력조절부와 벌룬 하우징(225) 사이에 압력조절 유로(P2)를 형성한다. 압력조절관(220)은 인슐린 공급튜브(210)의 외측에 일체형으로 형성되는 것도 가능하고, 별개의 튜브로 형성되는 것도 가능하다.The balloon unit 200 includes a balloon 215 and a balloon housing 225. The balloon 215 is formed of an elastic material at one point of the insulin supply tube 210 so that its outer diameter can be expanded. The balloon housing 225 is provided to surround the outside of the balloon 215, and is connected to the above-described pressure regulator with the pressure regulator pipe 220 between the balloon 215 and the balloon housing 225. The pressure control pipe 220 forms a pressure control flow path (P2) between the pressure control unit and the balloon housing 225. The pressure control tube 220 may be formed integrally with the outside of the insulin supply tube 210, or may be formed as a separate tube.
벌룬 하우징(225)은 벌룬(215)과의 사이에 음압 형성 공간을 형성한다. 압력조절 유로(P2)를 통하여 음압이 형성되면 벌룬(215)은 벌룬 하우징(225)의 내부에서 팽창하게 된다. 이 때 벌룬(215)이 확장된 상태에서 벌룬(215) 내부의 용량이 증가하게 되면 주사부 측으로부터 주사부 내측에 존재하던 인슐린이 벌룬(215) 측으로 벌룬(215) 내부에서 증가한 용량만큼 이동하게 되고, 이 때 혈관 내의 혈액이 함께 유입된다.The balloon housing 225 forms a negative pressure forming space between the balloon housing 215 and the balloon housing 225 . When negative pressure is formed through the pressure control passage (P2), the balloon 215 expands inside the balloon housing 225. At this time, when the balloon 215 is expanded and the capacity inside the balloon 215 increases, the insulin present inside the injection unit moves from the injection unit side to the balloon 215 side by the increased capacity inside the balloon 215. And at this time, blood within the blood vessels flows in together.
도 3을 참조하여 일 실시예에 따른 주사부를 설명한다. 도 3은 일 실시예에 따른 주사부의 모습을 나타내는 개략도이다.A scanning unit according to an embodiment will be described with reference to FIG. 3 . Figure 3 is a schematic diagram showing the appearance of a scanning unit according to one embodiment.
혈당측정 센서(350)는 인슐린 공급 경로(P1) 중 주사 바늘(310)에 인접한 위치에 구비될 수 있다. 앞서 설명한 바와 같이 본 실시예에 따른 주사부는 혈액을 일정한 용량만큼 역방향(D2), 즉 인슐린의 공급방향(D1)의 반대 방향으로 유입시킴으로써 혈당측정 센서(350)와 혈액이 접촉할 수 있도록 한다.The blood sugar measurement sensor 350 may be installed at a location adjacent to the injection needle 310 in the insulin supply path (P1). As described above, the injection unit according to this embodiment allows blood to come into contact with the blood sugar measurement sensor 350 by flowing a certain amount of blood in the reverse direction (D2), that is, in the direction opposite to the insulin supply direction (D1).
기존의 바늘 일체형 센서를 이용하여 인슐린 투입과 혈당 측정을 동시에 수행하는 경우 바늘 내부 및 바늘의 첨단부에서는 단위 부피 당 혈액에 비하여 인슐인의 농도가 더 높게 형성되므로 혈당의 측정이 정확히 이루어지지 않는 문제가 발생할 수 있고, 혈액과의 장기간 접촉으로 인하여 센서의 효율이 저하되는 문제가 있으나, 본 실시예에 따른 바늘부의 경우 혈당의 측정 시에만 혈액을 유입시켜 접촉하게 되므로 이러한 문제를 해결할 수 있다.When insulin injection and blood sugar measurement are performed simultaneously using an existing needle-integrated sensor, the concentration of insulin is higher inside the needle and at the tip of the needle than the blood per unit volume, so blood sugar measurement is not performed accurately. may occur, and there is a problem that the efficiency of the sensor is reduced due to long-term contact with blood. However, in the case of the needle unit according to this embodiment, this problem can be solved because blood flows in and comes into contact only when measuring blood sugar.
도 4를 참조하여 일 실시예에 따른 압력조절부를 설명한다. 도 4는 일 실시예에 따른 압력조절부의 모습을 나타는 단면도이다.A pressure regulator according to an embodiment will be described with reference to FIG. 4 . Figure 4 is a cross-sectional view showing the pressure regulator according to one embodiment.
압력조절부(190)는 다양한 방식으로 구현이 가능하다. 본 실시예에 따른 압력조절부(190)는 실린더부(191)와 피스톤부(193)를 포함한다. 실린더부(191)는 중공의 형상으로 형성되고 일측이 압력조절 유로(P2)에 연결되어 실린더부(191) 내부의 공간(P2-1)과 압력조절 유로(P2)를 연결시킨다.The pressure control unit 190 can be implemented in various ways. The pressure adjusting unit 190 according to this embodiment includes a cylinder unit 191 and a piston unit 193. The cylinder unit 191 is formed in a hollow shape and one side is connected to the pressure control flow path (P2) to connect the space (P2-1) inside the cylinder part 191 and the pressure control flow path (P2).
피스톤부(193)는 실린더부(191) 내부에 수용되고, 실린더부(191) 내에서 왕복하여 상술한 벌룬 하우징 내의 압력을 조절한다.The piston unit 193 is accommodated inside the cylinder unit 191 and reciprocates within the cylinder unit 191 to adjust the pressure within the balloon housing described above.
도 5를 참조하여 혈당 측정 및 인슐린 투약 프로세스를 설명한다.The blood sugar measurement and insulin administration process will be described with reference to FIG. 5.
제어부는 앞서 설명한 바와 같이 혈당측정 센서 및 혈당측정부로부터 혈당측정치를 전달받고, 혈당 관리를 위한 인슐린 투입명령을 생성하여 인슐린 펌프로 전송한다. 인슐린 투여량과 단위 시간당 혈당 변화량을 측정하여 이로부터 혈당 관리 플랜에 따라 인슐린의 투여량을 제어한다.As described above, the control unit receives blood sugar measurement values from the blood sugar measurement sensor and blood sugar measurement unit, generates an insulin injection command for blood sugar management, and transmits it to the insulin pump. Insulin dosage and blood sugar change per unit time are measured and the insulin dosage is controlled according to the blood sugar management plan.
구체적으로 음압형성부에 음압이 형성되면, 벌룬이 확장되고, 주사부 내측으로 혈액이 일정량 유입되어 내부에 위치한 혈당측정센서와 혈액이 접촉하도록 한 상태에서 혈당을 측정한다. 혈당 측정 후에는 음압이 해체되어 벌룬이 원상태로 돌아가게 되면 혈액이 다시 주사바늘을 통하여 혈관으로 투입된다.Specifically, when negative pressure is formed in the negative pressure forming part, the balloon expands, a certain amount of blood flows into the injection part, and blood sugar is measured while the blood comes into contact with the blood sugar measurement sensor located inside. After measuring blood sugar, the negative pressure is dismantled and the balloon returns to its original state, and the blood is again injected into the blood vessel through the needle.
이후 측정된 혈당 데이터를 이용하여 인슐린 투입량 조절하여 인슐린 투입한다. 이 때 제어부는 측정된 혈당 데이터에 따라 목표혈당치를 설정하고, 목표혈당치까지 혈당을 조절하기 위하여 도 5와 도시된 바와 같은 혈당조절 스케쥴 그래프를 설정한다. 이 후 주기적으로 체내의 혈당을 측정하여 단위 시간당 혈당 변화량을 산출하고, 기 설정된 혈당 조절 스케쥴곡선에 따라 단위 시간당 혈당 변화량을 조절하도록 투여되는 인슐린의 양을 증감시킬 수 있다.Afterwards, the insulin injection amount is adjusted using the measured blood sugar data and insulin is administered. At this time, the control unit sets the target blood sugar level according to the measured blood sugar data and sets a blood sugar control schedule graph as shown in FIG. 5 to control blood sugar to the target blood sugar level. Afterwards, the blood sugar level in the body is periodically measured to calculate the change in blood sugar per unit time, and the amount of insulin administered can be increased or decreased to control the change in blood sugar per unit time according to a preset blood sugar control schedule curve.
이상 본 발명의 바람직한 실시예에 대하여 설명하였으나, 본 발명의 기술적 사상이 상술한 바람직한 실시예에 한정되는 것은 아니며, 특허청구범위에 구체화된 본 발명의 기술적 사상을 벗어나지 않는 범주에서 다양하게 구현될 수 있다.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 implemented in various ways without departing from the technical idea of the present invention specified in the patent claims. there is.

Claims (7)

  1. 인슐린 공급튜브를 통하여 인슐린을 공급하는 인슐린 공급부;An insulin supply unit that supplies insulin through an insulin supply tube;
    상기 인슐린 공급부로부터 공급되는 인슐린을 일정량만큼 역류시키는 음압형성부;a negative pressure forming unit that refluxes the insulin supplied from the insulin supply unit by a certain amount;
    상기 인슐린 공급튜브를 통하여 공급되는 인슐린을 체내에 주입하는 주사 바늘과, 상기 인슐린 공급튜브가 형성하는 인슐린 공급경로 내에 위치하여 혈당을 측정하는 혈당측정 센서를 포함하는 주사부;an injection unit including an injection needle for injecting insulin supplied through the insulin supply tube into the body, and a blood sugar measurement sensor located within the insulin supply path formed by the insulin supply tube to measure blood sugar;
    상기 혈당측정 센서로부터 측정된 혈당 측정 데이터를 수집하는 혈당 측정부; 및a blood sugar measurement unit that collects blood sugar measurement data measured from the blood sugar measurement sensor; and
    혈당 측정 시 상기 음압형성부를 제어하여 주사 바늘을 통하여 체내 혈액을 일정량 유입시킨 상태에서 상기 혈당측정 센서를 제어하여 상기 유입된 혈액의 혈당을 측정하는 제어부;를 포함하는 연속혈당 측정 및 인슐린 투입장치.When measuring blood sugar, a control unit that controls the negative pressure forming unit to control the blood glucose measurement sensor to measure the blood sugar level of the inflow blood while allowing a certain amount of blood into the body through the injection needle.
  2. 제1항에 있어서,According to paragraph 1,
    상기 음압형성부는,The negative pressure forming unit,
    상기 인슐린 공급부로부터의 인슐린 공급을 차단하는 차단부;A blocking unit that blocks insulin supply from the insulin supply unit;
    상기 인슐린 공급튜브 중 일 지점의 단면적을 확장가능하도록 형성되는 벌룬부; 및a balloon portion formed to expand the cross-sectional area of one point of the insulin supply tube; and
    상기 벌룬부의 외측에 음압을 형성하거나 음압을 제거하는 압력조절부;를 포함하고,It includes a pressure regulator that creates negative pressure or removes negative pressure on the outside of the balloon portion,
    상기 제어부는 상기 차단부를 통하여 인슐린 공급을 차단한 상태에서 상기 압력조절부를 제어하여 상기 벌룬부를 확장시켜서 상기 주사 바늘을 통하여 혈액을 일정량 유입시키는 연속혈당 측정 및 인슐린 투입장치.A continuous blood sugar measurement and insulin injection device in which the control unit controls the pressure control unit to expand the balloon unit while blocking the insulin supply through the blocking unit, thereby allowing a certain amount of blood to flow through the injection needle.
  3. 제2항에 있어서,According to paragraph 2,
    상기 벌룬부는,The balloon part,
    상기 인슐린 공급튜브의 일 지점에 탄성재질로 형성되어 외경이 확장가능하도록 형성되는 벌룬; 및A balloon formed of an elastic material at one point of the insulin supply tube so that the outer diameter is expandable; and
    상기 벌룬의 외곽을 둘러싸도록 구비되고, 상기 벌룬과의 사이에 상기 압력조절부에 압력조절 유로로 연결되는 음압 형성 공간을 형성하는 벌룬 하우징;을 포함하는 연속혈당 측정 및 인슐린 투입장치.A balloon housing provided to surround the outside of the balloon and forming a negative pressure forming space between the balloon and the pressure control unit and connected to the pressure control flow path.
  4. 제3항에 있어서,According to paragraph 3,
    상기 압력조절부는,The pressure regulator,
    중공의 형상으로 형성되고 일측이 상기 압력조절 유로에 연결되는 실린더부; 및A cylinder portion formed in a hollow shape and one side of which is connected to the pressure control passage; and
    상기 실린더부 내부에 수용되고, 상기 실린더부 내에서 왕복하여 상기 벌룬 하우징 내의 압력을 조절하는 피스톤부;를 포함하는 연속혈당 측정 및 인슐린 투입장치.A piston unit accommodated inside the cylinder unit and reciprocating within the cylinder unit to adjust the pressure within the balloon housing.
  5. 제1항에 있어서,According to paragraph 1,
    상기 혈당측정 센서는 상기 인슐린 공급 경로 중 상기 주사 바늘에 인접한 위치에 구비되는 연속혈당 측정 및 인슐린 투입장치.The blood sugar measurement sensor is a continuous blood sugar measurement and insulin injection device provided at a position adjacent to the injection needle in the insulin supply path.
  6. 제5항에 있어서,According to clause 5,
    상기 음압형성부는 상기 유입된 혈액이 상기 혈당측정 센서까지 유입되도록 역류시키는 연속혈당 측정 및 인슐린 투입장치.The negative pressure forming unit is a continuous blood sugar measurement and insulin injection device that causes the introduced blood to flow back to the blood sugar measurement sensor.
  7. 제1항에 있어서,According to paragraph 1,
    상기 제어부는 상기 혈당 측정부로부터 전달된 혈당 측정 데이터로부터 단위 시간당 혈당 변화량을 산출하고, 기 설정된 혈당 조절 스케쥴곡선에 따라 상기 단위 시간당 혈당 변화량을 조절하도록 투여되는 상기 인슐린의 양을 증감시키는 연속혈당 측정 및 인슐린 투입장치.The control unit calculates the amount of change in blood sugar per unit time from the blood sugar measurement data transmitted from the blood sugar measurement unit, and measures continuous blood sugar to increase or decrease the amount of insulin administered to control the amount of change in blood sugar per unit time according to a preset blood sugar control schedule curve. and insulin injection device.
PCT/KR2023/008897 2022-07-05 2023-06-27 Continuous blood sugar measurement and insulin injection apparatus WO2024010265A1 (en)

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KR20180118368A (en) * 2017-04-21 2018-10-31 최규동 Nleedle Unit with Glucose Sensor and Simuteneous Infusion-Glucose Detecting System
JP2019513452A (en) * 2016-04-06 2019-05-30 ウォーク バスキュラー， エルエルシーＷａｌｋ Ｖａｓｃｕｌａｒ， Ｌｌｃ Systems and methods for thrombolysis and drug delivery
KR20200103365A (en) * 2019-02-25 2020-09-02 인제대학교 산학협력단 Negative pressure drain device with flow control valve
KR20210012715A (en) * 2019-07-26 2021-02-03 주식회사 필로시스 Injection module and inject medicine device comprising the same
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JP2019513452A (en) * 2016-04-06 2019-05-30 ウォーク バスキュラー， エルエルシーＷａｌｋ Ｖａｓｃｕｌａｒ， Ｌｌｃ Systems and methods for thrombolysis and drug delivery
KR20180118368A (en) * 2017-04-21 2018-10-31 최규동 Nleedle Unit with Glucose Sensor and Simuteneous Infusion-Glucose Detecting System
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