WO2021090531A1 - Pancréas artificiel - Google Patents

Pancréas artificiel Download PDF

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Publication number
WO2021090531A1
WO2021090531A1 PCT/JP2020/025580 JP2020025580W WO2021090531A1 WO 2021090531 A1 WO2021090531 A1 WO 2021090531A1 JP 2020025580 W JP2020025580 W JP 2020025580W WO 2021090531 A1 WO2021090531 A1 WO 2021090531A1
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WIPO (PCT)
Prior art keywords
venous blood
main body
blood
artificial pancreas
unit
Prior art date
Application number
PCT/JP2020/025580
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English (en)
Japanese (ja)
Inventor
孝 浅香
仁是 佐藤
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テルモ株式会社
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Publication of WO2021090531A1 publication Critical patent/WO2021090531A1/fr

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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
    • A61B5/145—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
    • A61B5/1455—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 using optical sensors, e.g. spectral photometrical oximeters
    • 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
    • A61B5/1486—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 using enzyme electrodes, e.g. with immobilised oxidase
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • 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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps

Definitions

  • the present invention relates to an artificial pancreas that realizes stable blood glucose control in patients after highly invasive surgery.
  • Factor (1) is excessive secretion of hormones that raise blood glucose levels due to invasive stress caused by general anesthesia or surgery.
  • the factor (2) is a decrease in the blood glucose level suppressing function due to an increase in insulin resistance due to the physiological stress of surgery.
  • the blood glucose level rises, and depending on the degree of invasiveness, the blood glucose level becomes higher than usual for 3 to 7 days.
  • hyperglycemic symptoms become more prominent. Hyperglycemic conditions reduce the patient's protective function against infection, resulting in a high postoperative infectious complication rate and mortality rate.
  • the patient group when strict blood glucose control of 80 to 120 mg / dl by intensive insulin therapy (frequent insulin injection) is performed is 180 to 200 mg / dl. It was reported that the mortality rate was reduced, bloodstream infection was suppressed, dialysis treatment was suppressed, and the length of hospital stay in the ICU was shortened for the group of patients with relatively loose glycemic control.
  • the risk of hypoglycemia caused by demanding strict glycemic control was pointed out, and the validity of strict glycemic control was controversial. against this background, we want to strictly control blood glucose, but because of the high risk of frequent hypoglycemia, the trend is to loosely control blood glucose for diabetic patients after surgery, which is currently highly invasive. There is.
  • the blood glucose control of patients after surgery is classified into three types, which are the widely used sliding scale method, continuous insulin administration method, and artificial pancreas.
  • the implementation of the sliding scale method and the continuous insulin administration method is actually difficult to carry out strict glycemic control (for example, glycemic control of 80 to 120 mg / dl).
  • the reason for the difficulty is as follows.
  • healthcare professionals are always responsible for multiple patients. It is practically impossible for a healthcare professional to frequently measure the blood glucose level and administer insulin to each patient in order to keep track of the blood glucose level trend of each patient.
  • blood glucose measurement does not necessarily measure blood gas with an accuracy of ⁇ 2 to 3%, but there are variations in measured values due to measurement performed by a self-measuring machine with an accuracy of about ⁇ 10%.
  • the device performs all of blood glucose measurement, drug dose calculation, and drug administration work. Therefore, the artificial pancreas can realize strict blood glucose control from the viewpoints of risk reduction, cost reduction, and effective utilization of resources.
  • Patent Document 1 discloses an artificial pancreas.
  • This artificial pancreas is suitable for a drug solution that causes fluctuations in blood glucose level such as insulin when a patient falls into a hypoglycemic state due to injury or illness of a patient or the like who is in a surgically hyperglycemic state invaded by surgery or injury or illness. Can be administered to.
  • the conventional artificial pancreas has a large device and requires complicated operations, and is mounted on a stand for movement.
  • Conventional artificial pancreas is used by moving the stand on the floor so that it is placed near the patient.
  • conventional artificial pancreas is capable of strict blood glucose control after surgery, it is difficult to use clinically because it requires large and complicated operations. Also, it is not easy to move a large artificial pancreas as the patient moves.
  • the present invention has been made to solve the above problems, and provides an easy-to-use artificial pancreas that can easily and surely realize stable blood glucose control of a diabetic patient after a highly invasive surgery.
  • the purpose is to do.
  • the subject is an artificial pancreas that controls blood glucose in a living body according to the present invention, and is arranged in a main body portion, a control unit arranged in the main body portion, and the main body portion.
  • a venous blood feeding section that passes venous blood obtained from the living body through the main body and returns the venous blood to the living body, and a venous blood feeding section that is arranged in the main body and passes through the main body by the venous blood feeding section.
  • a blood glucose level measuring unit that measures the blood glucose level of the venous blood and notifies the control unit of the blood glucose level
  • a connecting portion that is arranged in the main body and connects a drug solution cartridge for storing the drug solution, and the blood glucose level.
  • control unit When notified to the control unit, the control unit is characterized by comprising a drug solution administration operation unit for administering a predetermined amount of the drug solution according to the blood glucose level to the venous blood from the drug solution cartridge. Achieved by the artificial pancreas.
  • the main body portion only needs to be attached to a suitable place of a living body part of a patient, for example.
  • the blood glucose level measuring unit measures the blood glucose level of the venous blood passing through the main body and controls the blood glucose level.
  • the control unit operates the drug solution administration operation unit to administer a predetermined amount of the drug solution according to the blood glucose level from the drug solution cartridge to the venous blood in the venous blood flow path portion.
  • the blood glucose level can be measured and the drug solution can be administered according to the blood glucose level simply by passing venous blood through the main body. Therefore, the artificial pancreas can easily and surely realize stable glycemic control of highly invasive post-surgery patients, especially diabetic patients, and is easy to use, even if the medical staff does not always manage it. become.
  • the drug solution cartridge is an insulin cartridge that administers insulin to the venous blood in the venous blood flow path when the blood glucose level is larger than a predetermined value, and the above. It is characterized by having a glucose cartridge for administering glucose to the venous blood in the venous blood flow path portion when the blood glucose level is smaller than a predetermined value.
  • the main body is attached to a suitable place in the living body of the patient, insulin is added to the venous blood in the venous blood flow path when the blood glucose level is larger than a predetermined value.
  • insulin is added to the venous blood in the venous blood flow path when the blood glucose level is larger than a predetermined value.
  • Can be administered, and glucose can be administered to venous blood in the venous blood flow path when the blood glucose level is smaller than a predetermined value. Therefore, the artificial pancreas can easily and surely realize stable glycemic control of diabetic patients after highly invasive surgery.
  • the venous blood pumping portion is arranged along the main body portion to guide the venous blood, and the venous blood obtained from the living body is described as described above. It is characterized by having a liquid feeding pump that returns to the living body after passing through a guide line portion.
  • venous blood can be passed along the main body portion through this guide conduit portion. In this way, the blood glucose level measurement work and the drug solution administration work can be reliably performed while the venous blood is passed through the guide tube portion.
  • the main body portion is formed in a ring shape, and the main body portion is held at an appropriate position of the living body through a part of the living body.
  • the main body portion is formed in a ring shape, the main body portion can be held by the arm through, for example, a hand, which is a part of the patient's living body at an appropriate position. Therefore, the main body can be easily and surely held in the living body.
  • the invention according to claim 5 is preferably characterized in that a battery for supplying power to the control unit, the drug solution administration operation unit, and the liquid delivery pump is arranged in the main body unit.
  • the guide line portion is arranged so as to make substantially a circle in the main body portion, and the control unit is the vein when the venous blood passes through the guide line portion. It is characterized by completing the measurement of the blood glucose level of blood, the determination of the dose of the drug solution to the venous blood, and the operation of administering the drug solution to the venous blood.
  • the venous blood control unit measures the blood glucose level of the venous blood, determines the dose of the drug solution to the venous blood, and administers the drug solution to the venous blood when the venous blood passes through the guide tube. Can be completed.
  • the guide conduit portion returns the first lumen through which the venous blood has passed from the living body into the main body and the venous blood having passed through the main body into the living body. It has a second lumen, and the first lumen and the second lumen are arranged in parallel and connected to an indwelling needle.
  • the route for flowing venous blood is to obtain venous blood from a living body using one indwelling needle and the first and second lumens, measure the blood glucose level, and if necessary, a drug solution. Can be returned to the living body after administration of.
  • the antithrombotic drug solution supply unit for supplying the antithrombotic drug to the venous blood and the physiological saline supply unit for supplying the physiological saline to the venous blood are the main bodies. It is characterized by being connected to a unit.
  • the main body portion to be attached to a suitable part of the living body is C-shaped.
  • the main body portion when the main body portion is C-shaped, it can be attached or detached from a direction intersecting with the arm, for example, as compared with the case where the main body portion is a ring type. This makes it even easier to attach and remove the artificial pancreas.
  • the power supply unit for supplying power to the control unit, the chemical solution administration operation unit, and the liquid supply pump is arranged outside the main body unit. And.
  • the artificial pancreas can be operated by receiving the power supply from the power supply unit arranged outside the main body.
  • the present invention it is possible to provide an easy-to-use artificial pancreas that can easily and surely realize stable blood glucose control of a diabetic patient after a highly invasive surgical operation.
  • FIG. 1st Embodiment of the artificial pancreas of this invention It is a figure which shows the state which actually uses the preferable 1st Embodiment of the artificial pancreas of this invention. It is a front view which shows the artificial pancreas shown in FIG. It is a figure which shows the internal composition example of the artificial pancreas shown in FIG. It is a figure which shows the internal composition example of the artificial pancreas shown in FIG. It is a figure which shows the preferable 2nd Embodiment of the artificial pancreas of this invention. It is a figure which shows the preferable 3rd Embodiment of the artificial pancreas of this invention.
  • FIG. 1 is a diagram showing a state in which a preferred first embodiment of the artificial pancreas of the present invention is actually used.
  • FIG. 2 is a front view showing the artificial pancreas 1 shown in FIG.
  • FIG. 3 is a diagram showing an example of the internal configuration of the artificial pancreas 1 shown in FIG.
  • the artificial pancreas 1 shown in FIGS. 1 to 3 performs stable blood glucose control of patients after highly invasive surgery, particularly stable blood glucose control of diabetic patients.
  • the artificial pancreas 1 is a so-called disposable compact medical device that is preferably used only once. However, the artificial pancreas 1 may be regenerated and reusable.
  • the artificial pancreas 1 can also be referred to as a ring-type artificial pancreas set.
  • the artificial pancreas 1 is easily attached to a suitable part of the patient's body, for example, as shown in FIG. 1, on the patient's arm 300, and the artificial pancreas 1 is integrated with the patient.
  • the artificial pancreas 1 can be expected to solve the problem of tube handling when the patient moves from place to place.
  • the therapy with artificial pancreas 1 performs all blood glucose measurement, drug dose calculation and drug administration work.
  • healthcare professionals are often in charge of multiple patients at all times.
  • the medical staff can always easily and surely grasp the blood glucose level trend of each patient. Therefore, the artificial pancreas 1 is suitable for highly invasive post-surgical patients, especially diabetic patients, from the viewpoints of risk reduction by strict blood glucose control, cost reduction by miniaturization, and effective utilization of resources. , Stable and strict blood glucose control is feasible.
  • the artificial pancreas 1 is roughly composed of a main body portion 2, a venous blood feeding unit 3, a blood glucose level measuring unit 4, a connecting unit 5, and a drug solution administration operating unit 6A. , 6B and a control unit 10.
  • the main body 2 also has a battery 9.
  • the battery 9 is built in the main body 2, and a primary battery such as a button battery can be used. For example, power is supplied to each element described later for at least 5 to 6 hours or more.
  • the type of the battery 9 is not particularly limited, and the duration of the battery 9 is not particularly limited and can be set arbitrarily.
  • the main body 2 shown in FIGS. 1 to 3 is made of, for example, a material such as plastic or silicon that does not cause any problem even if it comes into contact with a living body.
  • the main body portion 2 is, for example, a ring-shaped member having no break along the circumferential direction and having a hollow portion 2H along the circumferential direction as shown in FIG. That is, the artificial pancreas 1 is a bracelet-shaped pancreas device.
  • the main body 2 is preferably transparent or translucent so that the medical staff can see the state of venous blood passing through the inside, but may be opaque if it is not necessary.
  • the inner diameter D1 of the main body 2 shown in FIG. 1 is preferably set in the range of 40 mm to 80 mm so that the main body 2 can be held through the patient's arm 300.
  • the outer diameter D2 is preferably set in the range of 70 mm to 120 mm. It is preferable to prepare several sizes of the main body 2 in advance so that the inner diameter D1 and the outer diameter D2 of the main body 2 can be selected according to the physique and age of the patient.
  • the main body 2 is formed by an outer peripheral surface 2A, an inner peripheral surface 2B, and left and right side surfaces 2C and 2C.
  • the outer peripheral surface 2A, the inner peripheral surface 2B, and the left and right side surfaces 2C and 2C have a ring-shaped hollow portion 2H inside.
  • a non-slip sheet can be arranged on the inner peripheral surface 2B, if necessary, so that the main body 2 does not rotate with respect to the arm 300.
  • FIG. 4 is a diagram showing an example of the venous blood feeding unit 3.
  • the venous blood feeding unit 3 shown in FIGS. 3 and 4 is arranged in the main body 2, and the venous blood obtained from the arm 300 of the patient who is a living body is passed through the main body 2 for almost one round, and the venous blood is passed through the arm 300. It has a function to return to.
  • the venous blood feeding unit 3 has a guide line portion 11 and a liquid feeding pump 12.
  • the guide pipeline portion 11 is arranged substantially once along the circular hollow portion 2H of the main body portion 2, and the guide pipeline portion 11 is arranged in a circular shape along the hollow portion 2H.
  • One end portion 11P of the guide conduit portion 11 extends from the hollow portion 2H of the main body portion 2 to the outside of the main body portion 2 as a flexible first lumen 11A formed of a thermoplastic resin or the like.
  • the other end 11Q of the guide conduit portion 11 extends from the hollow portion 2H of the main body portion 2 to the outside of the main body portion 2 as a flexible second lumen 11B formed of a thermoplastic resin or the like.
  • a flexible first lumen 11A formed of a thermoplastic resin or the like
  • the other end 11Q of the guide conduit portion 11 extends from the hollow portion 2H of the main body portion 2 to the outside of the main body portion 2 as a flexible second lumen 11B formed of a thermoplastic resin or the like.
  • Such a venous blood feeding route has a double lumen structure having a first lumen 11A and a second lumen 11B.
  • FIG. 4 shows a preferable structural example of the indwelling needle (indwelling catheter) 13.
  • the indwelling needle 13 has two lumens, an intake side tube portion 13A for taking in blood from the vein and a return side tube portion 13B for returning blood to the vein.
  • One end side of the intake side tube portion 13A is liquidtight by being fitted inside the first lumen 11A by providing a rib of a predetermined height or a groove of a predetermined depth in the circumferential direction of the outer circumference thereof. It is connected to the.
  • one end side of the return side tube portion 13B is liquidtightly connected by being fitted inside the second lumen 11B by providing a rib or a groove in the circumferential direction of the outer circumference thereof.
  • the intake side tube portion 13A has an intake flow path 13C shown by a broken line, and this intake flow path 13C is connected to the first lumen 11A and reaches the tip opening 13D of the indwelling needle 13.
  • the return side tube portion 13B has a return flow path 13E as shown by a broken line, and the return flow path 13E is connected to the second lumen 11B and reaches the return opening 13F. ing.
  • the tip opening 13D is formed at the tip of the indwelling needle 13, whereas the return opening 13F is formed at a position in the middle of the indwelling needle 13. That is, the tip opening 13D and the return opening 13F are located at positions separated by a predetermined distance in the axial direction of the indwelling needle 13. However, the tip opening 13D and the return opening 13F are both located in the blood vessel of the vein when the indwelling needle 13 is pierced into the blood vessel.
  • the liquid feed pump 12 is arranged in the main body 2.
  • the liquid feed pump 12 is configured to sequentially press the elastically deformable guide pipe portion 11 by, for example, a plurality of fingers (not shown) pulsating in the middle of the guide pipe portion 11.
  • the liquid feed pump 12 can send a predetermined amount (mL / h) of venous blood from the vein to the main body 2.
  • a peristaltic type peripheral type
  • the control unit 10 has a blood glucose control start button 40 for venous blood.
  • the indwelling needle 13 is pierced into the vein of the arm 300 and indwelled.
  • an indwelling needle having an outer cylinder made of flexible plastic and an inner cylinder of a metal needle for puncture is used and made of flexible plastic in the vein.
  • the outer cylinder (not shown) of the above the inner cylinder of the metal needle for puncture is pulled out, and then the indwelling needle 13 using the outer cylinder made of flexible plastic (not shown) as a guide portion. Is placed in the vein of the arm 300 by inserting.
  • the liquid feeding pump 12 is operated by the command of the control unit 10.
  • the liquid feeding pump 12 is activated, the patient's venous blood is fed from the indwelling needle 13 in the feeding direction M, as shown in FIGS. 1 and 4.
  • Venous blood is guided around the guide line portion 11 in the main body portion 2 in the R direction through the intake side tube portion 13A and the first lumen 11A.
  • Venous blood is sent once in the main body 2, and the blood glucose level is measured during the delivery, and insulin or a predetermined concentration of glucose (predetermined concentration of glucose solution) is administered in a small amount according to the blood glucose level.
  • Examples of the applicable insulin include fast-acting insulin of human insulin preparation, super-fast-acting insulin analog of mixed human insulin and insulin analogy preparation, biphasic insulin analog, combined dissolved insulin analog and the like.
  • the blood glucose level measuring unit 4 shown in FIG. 3 is arranged in the main body 2 near the guide tube portion 11 of the venous blood feeding unit 3.
  • the blood glucose level of the venous blood that is sent by going around the guide tube portion 11 of the venous blood feeding section 3 is preferably continuously non-invasive and for venous blood. Measure without contact.
  • the blood glucose level measuring unit 4 notifies the control unit 10 of the blood glucose level measurement data DT.
  • the blood glucose level measuring unit 4 exerts a continuous blood glucose monitoring function for continuously measuring the blood glucose level of venous blood.
  • the glucose sensor as the detection means of the blood glucose level measuring unit 4
  • near infrared (700 to 1050 nm) spectroscopy is preferably used.
  • this near-infrared spectroscopy when measuring changes in blood glucose level over time, the measured values of blood glucose level are obtained at a plurality of elapsed times, and the veins are irradiated with near-infrared light to obtain the measured values from the veins.
  • the absorbance for each of a plurality of wavelengths is obtained in the near infrared set wavelength range, the wavelength having a high correlation with the measured value is specified, and the absorbance at the specified wavelength is used.
  • a calculation formula for calculating the measured value is derived, and at another elapsed time, the vein is irradiated with near-infrared light, the diffused reflected light or transmitted light from the vein is received, and the absorbance at the specified wavelength is obtained.
  • the blood glucose level is calculated from the above formula, but the near-infrared spectroscopy is not particularly limited. Further, as the glucose sensor which is the detecting means of the blood glucose level measuring unit 4, for example, an enzyme electrode or the like may be used.
  • connection unit 5 and the drug solution administration operation units 6A and 6B will be described.
  • the connecting portion 5 is attached with the chemical solution administration operating portions 6A and 6B side by side.
  • a diaphragm type microinjection pump can be adopted.
  • the connecting portion 5 is provided on the side surface 2C of the main body portion 2, and is preferably made of the same plastic material as the main body portion 2.
  • the main body 2 detachably connects the insulin cartridge 21 and the glucose cartridge 22 in order to increase or decrease the blood glucose level of venous blood.
  • the insulin cartridge 21 and the glucose cartridge 22 are examples of chemical cartridges.
  • Insulin is stored in the insulin cartridge 21.
  • insulin When insulin is administered in small amounts to venous blood, it lowers the blood sugar level in venous blood.
  • Glucose is stored in the glucose cartridge 22.
  • glucol When glucol is administered in small amounts to venous blood, it raises the blood sugar level in venous blood.
  • the insulin cartridge 21 and the glucose cartridge 22 are the same size, but for example, the insulin cartridge 21 is colored red and the glucose cartridge 22 is colored blue so that they can be easily distinguished visually.
  • the insulin cartridge 21 is detachably connected to the drug solution administration operation unit 6A at the connection unit 5.
  • the glucose cartridge 22 is detachably connected to the drug solution administration operation unit 6B at the connection unit 5.
  • the control unit 10 shown in FIG. 3 is a drug solution administration operation unit 6A on the insulin cartridge 21 side based on the blood glucose level measurement data DT of venous blood that substantially goes around the guide tube portion 11 obtained by the blood glucose level measurement unit 4. Or drive the drug solution administration operation unit 6B on the glucose cartridge 22 side.
  • the control unit 10 has a memory 10M, and the memory 10M stores software of an algorithm for calculating an insulin dose and a glucose dose from the blood glucose level measurement data DT.
  • the control unit 10 drives the drug solution administration operation unit 6A. Then, the insulin of the insulin cartridge 21 is administered in a small amount into the venous blood passing through the guide tube portion 11 to lower the blood glucose level of the venous blood. Further, when the blood glucose level measurement data DT of venous blood that substantially goes around the guide tube portion 11 is smaller than the predetermined blood glucose level data, the control unit 10 drives the drug solution administration operation unit 6B.
  • Glucose of the glucose cartridge 22 is administered in a small amount into the venous blood passing through the guide tube portion 11 to raise the blood glucose level of the venous blood.
  • the control unit 10 receives a predetermined amount of insulin or a predetermined amount of glucose according to the magnitude of the blood glucose level of venous blood. Is administered in a small amount to the venous blood in the venous blood flow path to control the blood glucose level.
  • the display unit 30 may be arranged in the main body unit 2.
  • the display unit 30 can display the blood glucose level of venous blood, the amount of insulin administered in a small amount, and the amount of glucose administered in a small amount.
  • the battery 9 supplies power to the control unit 10, the blood glucose level measuring unit 4, and the liquid feeding pump 12.
  • the antithrombotic drug supply unit 41 is connected to the bag 41B containing the antithrombotic drug.
  • the saline supply unit 42 is connected to a bag 42B containing the saline solution.
  • the antithrombotic drug supply unit 41 is a drug solution supply unit that supplies an antithrombotic drug into venous blood passing through the guide tube portion 11 of the main body 2 as needed.
  • the physiological saline supply unit 42 smoothly flows an antithrombotic drug, for example, heparin, into the venous blood passing through the guide tube portion 11 of the main body 2 as needed. Supply.
  • valve 41G By opening the valve 41G, the antithrombotic drug in the bag 42B can be administered into the venous blood passing through the guide tube section 11 via the antithrombotic drug supply section 41.
  • the valve 42G By opening the valve 42G, the saline solution in the bag 42B can be administered into the venous blood passing through the guide tube portion 11 via the saline solution supply unit 42.
  • the valves 41G and 42G can be opened and closed manually. However, as shown in FIG. 3, the valves 41G and 42G may be opened and closed by a command from the control unit 10.
  • FIGS. 1 and 2 show an example of blood glucose control of venous blood by the artificial pancreas 1 described above with reference to FIGS. 1 to 4.
  • the insulin cartridge 21 is detachably connected to the drug solution administration operation unit 6A at the connection unit 5.
  • the glucose cartridge 22 is detachably connected to the drug solution administration operation unit 6B at the connection unit 5.
  • the inner peripheral surface 2B of the main body 2 is held at an appropriate position of the arm 300 when the main body 2 is inserted from the patient's hand.
  • the indwelling needle 13 is pierced into the vein of the arm 300, and the indwelling needle 13 is indwelled in the vein so as not to move, for example, using a tape.
  • an indwelling needle (not shown) having an outer cylinder made of flexible plastic and an inner cylinder of a metal needle for puncture can be used intravenously.
  • the inner cylinder of the metal needle for puncture is pulled out, and then the indwelling needle 13 using the outer cylinder made of flexible plastic (not shown) as a guide portion. Is placed in the vein of the arm 300 by inserting.
  • the tip opening 13D and the return opening 13F shown in FIG. 4 are both located in the vein of the vein.
  • the venous blood is taken into the intake flow path 13C from the tip opening 13D along the feeding direction M, and is taken into the first lumen 11A via the intake flow path 13C as the collected venous blood.
  • the venous blood returned after passing through the second lumen 11B venous blood whose blood glucose level is adjusted by containing insulin and / or glucose
  • the return opening 13F is located at a position separated from the indwelling needle 13 in the axial direction.
  • the liquid feed pump 12 is operated by the command of the control unit 10.
  • a predetermined amount of venous blood is fed in the feeding direction M as shown in FIGS. 1 and 4.
  • Venous blood is guided through the first lumen 11A through the guide conduit portion 11 in the main body portion 2 for substantially one round in the R direction.
  • the venous blood whose blood glucose level has been measured is returned to the vein of the arm along the return direction N through the indwelling needle 13 through the second lumen 11B and the same route.
  • the intake side tube portion 13A and the first lumen 11A of the indwelling needle 13 are used. Due to the double lumen structure using 13B, the first lumen 11A and the second lumen 11B, venous blood discharged from the body is returned to the body through the indwelling needle 13 by the same route.
  • the antithrombotic drug supply unit 41 supplies the antithrombotic drug into the venous blood passing through the guide tube portion 11 of the main body 2 as needed. Further, the physiological saline supply unit 42 supplies the physiological saline solution, if necessary, in order to smoothly flow the antithrombotic drug into the venous blood passing through the guide tube portion 11 of the main body portion 2.
  • the blood glucose level measuring unit 4 continuously measures the blood glucose level of the venous blood to be delivered in a non-invasive and non-contact manner on the way around the guide tube portion 11 of the venous blood feeding unit 3.
  • the blood glucose level measuring unit 4 notifies the control unit 10 of the blood glucose level measurement data DT while continuously measuring the blood glucose level of venous blood.
  • control unit 10 is a drug solution administration operation unit on the insulin cartridge 21 side based on the blood glucose level measurement data DT of venous blood that substantially goes around the guide tube portion 11 obtained by the blood glucose level measurement unit 4. 6A is driven, or the drug solution administration operation unit 6B on the glucose cartridge 22 side is driven.
  • the control unit 10 calculates the insulin dose and the glucose dose from the blood glucose level measurement data DT.
  • the control unit 10 drives the drug solution administration operation unit 6A. Then, the insulin of the insulin cartridge 21 is administered in a small amount into the venous blood passing through the guide tube portion 11 to lower the blood glucose level of the venous blood. Further, when the blood glucose level measurement data DT of venous blood that substantially goes around the guide tube portion 11 is smaller than the predetermined blood glucose level data, the control unit 10 drives the drug solution administration operation unit 6B. , Glucose of the glucose cartridge 22 is administered in a small amount into the venous blood passing through the guide tube portion 11 to raise the blood glucose level of the venous blood.
  • the control unit 10 applies a predetermined amount of insulin or a predetermined amount of glucose according to the magnitude of the blood glucose level of venous blood to the insulin cartridge 21 or glucose.
  • Blood glucose is controlled by injecting venous blood in the venous blood flow path from the cartridge 22.
  • the display unit 30 shown in FIG. 2 preferably displays the blood glucose level of venous blood, the amount of insulin administered in a small amount, and the amount of glucose administered in a small amount, so that the medical staff can confirm these values. it can.
  • the main body portion only needs to be attached to the part of the living body of the patient.
  • the blood glucose level measuring unit measures the blood glucose level of the venous blood passing through the main body and controls the blood glucose level.
  • the control unit operates the drug solution administration operation unit to administer a predetermined amount of the drug solution according to the blood glucose level from the drug solution cartridge to the venous blood in the venous blood flow path portion.
  • the blood glucose level can be measured and the drug solution can be administered according to the blood glucose level simply by passing venous blood through the main body. Therefore, even if the medical staff does not always manage it, it is possible to prevent poor blood sampling and easily and easily perform stable glycemic control of highly invasive patients after surgery, especially stable glycemic control of diabetic patients. It can be realized reliably and is easy to use.
  • the artificial pancreas of the first embodiment only needs to be attached to the patient's arm, for example.
  • the artificial pancreas is lightweight, small in size, inexpensive to manufacture, and easy to manage. Therefore, the artificial pancreas is easily available, and the artificial pancreas can be easily set or removed from the patient.
  • the venous blood from the patient can be taken out of the living body, the blood glucose level of the venous blood can be measured, and the venous blood feeding route for the minute administration of the drug solution can be easily secured.
  • the artificial pancreas is attached to the patient's arm, it can easily move with the patient when the patient moves.
  • the mortality rate can be improved by improving the blood glucose control of patients, improving the incidence of infection at the surgical site, and preventing the prognosis from deteriorating. It is possible to reduce the risk of hyperglycemia / hypoglycemia in medical staff, reduce the amount of work required for measuring blood glucose level and administering insulin and glycosyl, and unify the criteria for drug administration. For hospitals, the number of beds can be improved by improving the prognosis of patients.
  • the main body of the artificial pancreas of the first embodiment is a so-called ring type, it can be easily attached to the arm, which is one of the appropriate places for attaching the main body, by passing the patient's arm through the main body. Therefore, by using the artificial pancreas, the medical staff is freed from the complicated handling of the tube, which has been a problem when applying the artificial pancreas to the patient.
  • Venous blood can be completed with a small dose of insulin or a small dose of glucose.
  • the conventional artificial pancreas is mounted on a stand for movement because the device is large and requires complicated operations.
  • the conventional artificial pancreas is used by arranging it near the patient by moving the floor surface, and a large-scale and complicated operation is performed by a medical worker such as a nurse.
  • the artificial pancreas of the first embodiment when the artificial pancreas is attached to a part of the patient, for example, the arm, the measurement of the blood glucose level of venous blood is started and the vein is venous according to the blood glucose level.
  • a small amount of insulin or a small amount of glucose can be automatically, easily and surely administered to blood.
  • FIG. 5 shows a second embodiment of the artificial pancreas of the present invention.
  • the artificial pancreas 101 shown in FIG. 5 is different from the artificial pancreas 1 shown in FIG. 1 in the following points.
  • the main body 2 of the artificial pancreas 1 shown in FIG. 1 is a ring type, and when the main body 2 is attached to the arm 300, it moves to the arm 300 after putting a hand in the inner peripheral surface 2B of the main body 2. To do.
  • the main body 102 of the artificial pancreas 101 shown in FIG. 5 is made of elastically deformable plastic or the like, and the main body 102 forms a C shape instead of a ring shape. Therefore, the main body 2 has a notched portion 150.
  • the main body 102 is elastically deformed when the arm 300 is passed through the notch 150.
  • the main body 102 can be easily attached to the arm 300 from the side of the arm 300, and the inner peripheral surface 2B of the main body 102 can be brought into close contact with the peripheral surface of the arm 300.
  • the main body 2 When the main body 2 is C-shaped, it can be attached or detached from the direction where it intersects with the arm 300, for example, as compared with the case where the main body 2 is ring-shaped. Therefore, the attachment and detachment of the artificial pancreas 101 becomes easier. It also increases the width of the patient's arm thickness that can be applied.
  • FIG. 6 shows a third embodiment of the artificial pancreas of the present invention.
  • the difference between the artificial pancreas 201 of the second embodiment shown in FIG. 6 and the artificial pancreas 1 shown in FIG. 2 is as follows.
  • the artificial pancreas 201 has a connection portion 230 for an external power supply for connecting to the commercial power supply 220.
  • the connection unit 230 for an external power supply is electrically connected to a control unit 10 or the like that requires power supply via a detachable connector 231.
  • the connection unit 230 for the external power supply converts the commercial power supply 220 into a direct current having a predetermined voltage and supplies the commercial power supply 220 to the control unit 10 and the like. In this case, the built-in battery 9 may be omitted.
  • an external monitor display unit 330 may be connected to the control unit 10 by wire or wirelessly.
  • the external monitor display unit 330 is arranged at a place away from the patient's bed, such as a nurse center.
  • medical staff such as nurses can perform stable glycemic control of highly invasive patients after surgery, especially stable glycemic control of diabetic patients, on the external monitor display unit 330. You can definitely do it.
  • the same effects as those in the first embodiment are exhibited.
  • the venous blood flow path is obtained when the blood glucose level is larger than a predetermined value.
  • Insulin can be administered to the venous blood in the part, and glucose can be administered to the venous blood in the venous blood flow path when the blood glucose level is smaller than a predetermined value. Therefore, the artificial pancreas can easily and surely realize stable blood glucose control of patients after highly invasive surgery, particularly stable blood glucose control of diabetic patients.
  • the battery Since the battery is located in the main body, there is no need to supply power from the outside, and the artificial pancreas can be used independently even without an external power supply.
  • the venous blood control unit measures the blood glucose level of the venous blood, determines the dose of the drug solution to the venous blood, and administers the drug solution to the venous blood when the venous blood passes through the guide tube. Can be completed.
  • the route for venous blood flow is to obtain venous blood from the living body using one indwelling needle and the first and second lumens, measure the blood glucose level, administer a drug solution if necessary, and then return it to the living body. Can be done.
  • physiological saline to the venous blood together with an antithrombotic drug for preventing the thrombus of the venous blood, the generation of the thrombus due to the passage of the venous blood is prevented.
  • the present invention has been described above. However, the present invention is not limited to the above embodiment, and various modifications can be made without departing from the scope of claims.
  • the configuration of the above embodiment may be partially omitted or may be arbitrarily combined so as to be different from the above.
  • the main body portions 2, 102 are of the bracelet type so that they can be worn through the patient's arm 300.
  • the present invention is not limited to this, and the main body portion 2 may be a ring type or a C-shaped ankle type so that it can be attached to a patient's leg or ankle.
  • the main body may be formed in a slightly thick flat plate or sheet shape, for example, according to the outer shape of the arm 300, and elements such as a venous blood feeding portion may be arranged in the main body.
  • the main body may be attached to the surface of the skin of the arm so as to be detachably attached with an adhesive, or may be attached to the arm detachably using an attachment. You can also do it.
  • the artificial pancreas according to the present embodiment may be capable of acquiring other vital information in addition to the function of measuring the blood glucose level.
  • the artificial pancreas may not be disposable but may be washed and sterilized after use.
  • the artificial pancreas may be provided with a sensor that detects the body movement of the patient by using an acceleration sensor or the like.
  • the main body is not limited to being attached to the arms and legs that are a part of the patient's living body, but may be attached to a part other than the living body, for example, the frame of the bed on which the patient is sleeping.
  • liquid feed pump 13 ⁇ ⁇ ⁇ Indwelling needle, 13A ⁇ ⁇ ⁇ Intake side tube part, 13B ⁇ ⁇ ⁇ Return side tube part, 13C ⁇ ⁇ ⁇ Intake flow path, 13D ⁇ ⁇ ⁇ Tip opening, 13E ⁇ ⁇ ⁇ Return flow path, 13F ⁇ .. Opening for return, 21 ... Insulin cartridge (example of chemical cartridge), 22 ... Glucose cartridge (example of chemical cartridge), 30 ... Display, 40 ... Start of blood glucose control Button, 41 ... Anti-thrombotic drug supply unit, 41B ... Bag, 41G ... Valve, 42 ... Saline supply unit, 42B ... Bag, 42G ...

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Abstract

Le problème décrit par la présente invention est de fournir un pancréas artificiel utilisable permettant d'obtenir facilement et de manière fiable une gestion de la glycémie stable pour un patient après une opération chirurgicale hautement invasive. La solution selon l'invention porte sur un pancréas artificiel 1 qui comprend une unité de corps 2 ; une unité de contrôle 10 disposée dans l'unité de corps 2 ; une unité de transport de sang veineux 3 disposée dans l'unité de corps 2, faisant passer le sang veineux obtenu à partir d'un organisme vivant à travers l'unité de corps 2, et renvoyant le sang veineux à l'organisme vivant ; une unité de mesure du taux de glycémie 4 disposée dans l'unité de corps 2, mesurant le taux de glycémie du sang veineux passant à travers l'unité de corps 2 par l'unité de transport de sang veineux 3, et notifiant à l'unité de contrôle 10 le taux de glycémie ; une unité de connexion 5 disposée dans l'unité de corps 2 et connectant des cartouches de liquide pharmaceutique (21, 22) pour stocker un liquide pharmaceutique ; et des unités opérationnelles d'administration de liquide pharmaceutique 6A, 6B avec lesquelles, lorsque l'unité de contrôle 10 est notifiée du taux de glycémie, l'unité de contrôle 10 permet à une quantité prédéterminée de liquide pharmaceutique correspondant à la valeur du taux de glycémie d'être administrée au sang veineux à partir des cartouches de liquide pharmaceutique (21, 22).
PCT/JP2020/025580 2019-11-05 2020-06-29 Pancréas artificiel WO2021090531A1 (fr)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH07213604A (ja) * 1994-02-04 1995-08-15 Yoshihiko Suzuki 血糖値の制御装置
JP2006271839A (ja) * 2005-03-30 2006-10-12 Toray Ind Inc 体外循環医療カラム用補助用具
JP2017113144A (ja) * 2015-12-22 2017-06-29 日機装株式会社 クランプ装置

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH07213604A (ja) * 1994-02-04 1995-08-15 Yoshihiko Suzuki 血糖値の制御装置
JP2006271839A (ja) * 2005-03-30 2006-10-12 Toray Ind Inc 体外循環医療カラム用補助用具
JP2017113144A (ja) * 2015-12-22 2017-06-29 日機装株式会社 クランプ装置

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