WO2014049656A1 - Pompe de perfusion - Google Patents

Pompe de perfusion Download PDF

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Publication number
WO2014049656A1
WO2014049656A1 PCT/JP2012/006212 JP2012006212W WO2014049656A1 WO 2014049656 A1 WO2014049656 A1 WO 2014049656A1 JP 2012006212 W JP2012006212 W JP 2012006212W WO 2014049656 A1 WO2014049656 A1 WO 2014049656A1
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WO
WIPO (PCT)
Prior art keywords
bubble
infusion pump
bubbles
infusion
infusion tube
Prior art date
Application number
PCT/JP2012/006212
Other languages
English (en)
Japanese (ja)
Inventor
朋子 上村
Original Assignee
テルモ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Priority to JP2014537840A priority Critical patent/JPWO2014049656A1/ja
Priority to PCT/JP2012/006212 priority patent/WO2014049656A1/fr
Publication of WO2014049656A1 publication Critical patent/WO2014049656A1/fr

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Classifications

    • 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
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16831—Monitoring, detecting, signalling or eliminating infusion flow anomalies
    • 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
    • A61M5/36—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 with means for eliminating or preventing injection or infusion of air into body
    • 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
    • A61M5/36—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 with means for eliminating or preventing injection or infusion of air into body
    • A61M5/365—Air detectors
    • 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
    • A61M5/162—Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube
    • A61M2005/1623—Details of air intake
    • 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
    • A61M5/14212—Pumping with an aspiration and an expulsion action
    • A61M5/14228—Pumping with an aspiration and an expulsion action with linear peristaltic action, i.e. comprising at least three pressurising members or a helical member

Definitions

  • the present invention relates to an infusion pump for delivering a medicine to a patient.
  • the infusion pump is used, for example, in an intensive care unit (ICU) or the like, and is used to perform a liquid feeding treatment for a patient for a long time with high accuracy.
  • a predetermined drug bag (infusion bag) is arranged on the infusion pump, and an infusion tube lowered from the drug bag is sandwiched between the main body and the door, and the infusion tube is accommodated in the main body.
  • the door is held by closing the door.
  • the outer peripheral surface of the infusion tube set at a fixed position is sandwiched between a plurality of fingers in the main body and the inner surface of the door.
  • This infusion pump is a peristaltic infusion pump in which a plurality of fingers are sequentially pressed along the length of the outer peripheral surface of an infusion tube to deliver a drug to a patient through an indwelling needle (see Patent Document 1). reference).
  • the infusion tube is held vertically through the body of the infusion pump from top to bottom.
  • an infusion pump that holds an infusion tube in a horizontal direction in the body of the infusion pump has been proposed.
  • the infusion pump has a structure in which the infusion tube is held in the horizontal direction in the main body of the infusion pump so that the infusion tube passes vertically through the main body of the infusion pump from top to bottom. This is because the infusion tube does not get in the way even if a plurality of infusion pumps are stacked and held in a stacked state in the vertical position.
  • the upstream side of the infusion tube is disposed on the right side of the infusion pump main body, and the downstream side of the infusion tube is disposed on the left side of the infusion pump main body.
  • the drug is directed from the upstream side to the downstream side.
  • Liquid can be fed along a predetermined liquid feeding direction, and liquid can be fed correctly to the patient.
  • bubbles may be contained in the drug solution in the infusion tube.
  • This bubble is formed, for example, when air dissolved in the medicine gathers. If air bubbles are sent into the patient's blood vessel with the drug, the patient's body may be affected. Therefore, the present invention provides an infusion pump capable of preventing the influence on the patient's body by stopping the delivery of the medicine when bubbles are contained in the infusion tube. Objective.
  • the infusion pump of the present invention is an infusion pump for delivering a medicine to a patient using an infusion tube, and a bubble sensor for detecting bubbles generated in the infusion tube when the medicine is delivered; If the size of the bubble is equal to or larger than a predetermined size based on a drive motor for feeding the medicine in the infusion tube to the patient and a bubble detection signal of the bubble sensor, the volume of the bubble is a threshold value. Judging from the above, the drive motor is stopped to stop the liquid feeding operation of the medicine. When the size of the bubbles is less than the predetermined size, the number of the bubbles is counted and counted.
  • a controller that obtains the total volume of the bubbles from a number and stops the liquid feeding operation of the medicine by stopping the drive motor when the total volume reaches a predetermined threshold within a predetermined time. It is characterized by providing. According to the above configuration, the control unit can stop the medicine liquid supply operation when the bubble size is equal to or larger than the predetermined size, and the bubble size is less than the predetermined size. However, when the total volume of the counted number of bubbles reaches a predetermined threshold value within a predetermined time, the liquid feeding operation of the medicine can be stopped. Thereby, when air bubbles are contained in the liquid medicine in the infusion tube, the influence on the patient's body can be prevented by stopping the liquid feeding of the medicine.
  • an alarm unit that generates an alarm according to a command from the control unit when the drive motor is stopped to stop the liquid feeding operation of the medicine. It is characterized by that.
  • the control unit can generate an alarm when the liquid feeding operation of the medicine is stopped when the bubble size is equal to or larger than a predetermined size. For this reason, the medical worker can recognize that the liquid feeding operation of the medicine has been stopped and can quickly perform the subsequent countermeasures.
  • the alarm means stops the drive motor when the total volume of the counted bubbles reaches the threshold value and supplies the medicine.
  • an alarm is generated by a command from the control unit.
  • the control unit is a case where the size of the bubbles is less than a predetermined size, and the total volume of the counted number of bubbles reaches a predetermined threshold within a predetermined time, and the drug An alarm can be generated when the liquid feeding operation is stopped. For this reason, the medical worker can recognize that the liquid feeding operation of the medicine has been stopped and can quickly perform the subsequent countermeasures.
  • the predetermined size of the bubbles is approximately 5 mm.
  • the liquid feeding operation of the medicine is stopped, so that the bubble having a size of approximately 5 mm or more may affect the patient's body when entering the blood vessel.
  • the threshold value is approximately 1 mL.
  • the size of the bubbles does not reach a predetermined size, but when the total volume of the counted bubbles reaches a threshold value of approximately 1 mL, the liquid feeding operation of the medicine is stopped, The influence on the patient's body can be prevented.
  • a display unit for displaying information and an operation panel unit having operation buttons are arranged on the upper part of the main body of the infusion pump, and the lower part of the main body of the infusion pump is used for feeding the medicine. It is an area
  • the medical worker can perform the liquid feeding operation
  • the present invention can provide an infusion pump capable of preventing an influence on a patient's body by stopping the delivery of a medicine when bubbles are contained in the infusion tube.
  • FIG. 1 The perspective view which shows preferable embodiment of the infusion pump of this invention.
  • FIG. 1 is a perspective view showing a preferred embodiment of the infusion pump of the present invention.
  • FIG. 2 is a view of the infusion pump shown in FIG. 1 as viewed from the W direction.
  • the infusion pump 1 shown in FIGS. 1 and 2 is used, for example, in an intensive care unit (ICU, CCU, NICU) or the like, and is used for nutrition, such as anticancer agents, anesthetics, chemotherapeutic agents, blood transfusions, etc.
  • This is a micro continuous infusion pump that is used to perform a micro infusion treatment of a drug such as an agent (also referred to as a drug solution) for a relatively long time with high accuracy.
  • This infusion pump 1 is used, for example, for selecting a drug to be used from a drug library and feeding the selected drug.
  • This drug library is drug information which is a drug administration setting group including drug names registered in advance in the drug library database (DB). By using this drug library, a medical worker does not have to perform complicated administration settings each time, and can select a drug and set a drug.
  • DB drug library database
  • the infusion pump 1 can accurately deliver the liquid from the medicine bag 170 filled with the medicine 171 into the blood vessel of the patient P via the clamp 179, the infusion tube 200, and the indwelling needle 172. .
  • the drug is also called an infusion.
  • An infusion tube is also called an infusion line.
  • the infusion pump 1 has a main body cover 2 and a handle 2T, and the handle 2T can be extended in the N direction or stored in the T direction.
  • the main body cover 2 is also called a main body, and is integrally formed of a molded resin material having chemical resistance, and can be prevented from entering the infusion pump 1 even if a drug or the like is applied. have.
  • the main body cover 2 has the drip-proof treatment structure because the medicine 171 in the medicine bag 170 disposed above spills out or disinfects the disinfecting liquid used in the vicinity. Because there is.
  • a display unit 3 and an operation panel unit 4 are arranged on the upper portion 2 ⁇ / b> A of the main body cover 2.
  • the display unit 3 is an image display device, and uses, for example, a color liquid crystal display device. This display unit 3 can display not only information notation in Japanese but also information in a plurality of foreign languages as required.
  • the display unit 3 is disposed on the upper left side of the upper portion 2 ⁇ / b> A of the main body cover 2 and above the opening / closing cover 5.
  • the upper portion 2 ⁇ / b> A of the main body cover 2 is an upper half portion of the main body cover 2.
  • the lower part 2 ⁇ / b> B of the main body cover 2 is a lower half part of the main body cover 2.
  • a display portion 3 for displaying information and an operation panel portion 4 having a plurality of operation buttons are arranged on the upper portion 2A of the body cover 2 of the infusion pump 1, and a lower portion 2B of the body cover 2 of the infusion pump 1 is This is a region where an infusion tube 200 which is a liquid feeding member for feeding a medicine is arranged.
  • the medical worker can perform the liquid feeding operation of the medicine by the infusion pump 1 while confirming the information on the display unit 3 of the upper portion 2A of the main body cover 2.
  • the medical staff can operate the operation buttons on the operation panel unit 4 while checking the information on the display unit 3 of the upper portion 2A of the main body cover 2. For this reason, the operability of the infusion pump 1 is good.
  • the display unit 3 includes a display column 3B for a scheduled dose (mL) of drug administration, a display column 3C for an accumulated dose (mL) of drug administration, a display column 3D for a charge history, and a flow rate (mL / h).
  • the display unit 3 can also display a warning message.
  • the operation panel unit 4 is disposed on the right side of the display unit 3 in the upper part 2A of the main body cover 2, and the operation panel unit 4 includes, as an operation button, a lamp 4A (LED that functions as, for example, an operation indicator in the illustrated example. Etc., and blinks or lights green during normal operation, blinks or lights red during abnormal operation), fast-forward switch button 4B, start switch button 4C, stop switch button 4D, menu selection button 4E, power switch 4F, etc. Has been.
  • an opening / closing cover 5 serving as a lid member is provided on the lower portion 2B of the main body cover 2 so as to be openable and closable in the R direction around a rotating shaft 5A.
  • the open / close cover 5 is a plate-like lid member that is formed long along the X direction.
  • the tube mounting part 50 and the liquid feeding drive part 60 are disposed inside the opening / closing cover 5.
  • An infusion tube 200 made of a flexible thermoplastic resin such as soft vinyl chloride is set in the tube mounting portion 50, and the infusion tube 200 is connected to the tube mounting portion 50 by closing the open / close cover 5. , And can be mounted horizontally along the X direction (T direction). Note that the X direction, the Y direction, and the Z direction in FIGS.
  • the X direction is parallel to the T direction, which is the liquid feeding direction, and is the left-right direction of the infusion pump 1.
  • the Y direction is the front-rear direction of the infusion pump 1.
  • FIG. 3 is a perspective view showing a tube mounting portion 50 for opening the opening / closing cover 5 of the infusion pump 1 shown in FIGS. 1 and 2 and mounting the infusion tube 200.
  • the tube mounting part 50 and the liquid feeding drive part 60 are provided on the main body lower part 1B side of the infusion pump 1, and the tube mounting part 50 and the liquid feeding drive part 60 are operated with the display part 3.
  • a lower portion of the panel portion 4 is provided along the X direction.
  • the tube mounting portion 50 can cover the open / close cover 5 with the open / close cover 5 when the open / close cover 5 is closed in the CR direction around the rotation shaft 5A.
  • the tube mounting portion 50 includes a bubble sensor 51, an upstream blockage sensor 52, a downstream blockage sensor 53, a tube clamp portion 270, a first infusion tube guide portion 54 at the right side position, and a left side position.
  • a second infusion tube guide portion 55 is provided.
  • an infusion tube setting direction display unit 150 for clearly displaying the T direction that is the correct liquid feeding direction when the infusion tube 200 is set is provided in the vicinity of the tube mounting unit 50. ing.
  • the infusion tube setting direction display unit 150 includes, for example, a plurality of arrows 151.
  • the infusion tube setting direction display unit 150 may be printed directly on the lower part of the tube mounting part 50, for example, or may be printed on a seal-like member and attached to the lower part of the tube mounting part 50.
  • the infusion tube setting direction display unit 150 is arranged to clearly indicate the liquid feeding direction (T direction) in the correct direction of the medicine 171 by the infusion tube 200 set inside the opening / closing cover 5.
  • the infusion tube 200 it is possible to clearly indicate the T direction, which is the direction of drug delivery. For this reason, it can prevent reliably that a medical worker will attach the infusion tube 200 by the reverse direction accidentally.
  • the open / close cover 5 is a plate-like member made of a thin molded resin member in order to reduce the weight of the infusion pump 1. Thereby, the weight of the opening / closing cover 5 can be reduced, and the structure can be simplified.
  • the opening / closing cover 5 has two hinge portions 2H and 2H that allow the tube mounting portion 50 to be covered so as to be openable and closable along the CS direction and the CR direction about the rotation shaft 5A. It is supported with respect to the main body lower part 2B.
  • the two hinge portions 2H and 2H are arranged corresponding to the first hook member 5D and the second hook member 5E, respectively.
  • an opening / closing operation lever 260 is provided at the upper right portion on the surface side of the opening / closing cover 5.
  • an infusion tube pressing member 500 On the inner surface side of the opening / closing cover 5, an infusion tube pressing member 500, a first hook member 5D, and a second hook member 5E are provided.
  • the infusion tube pressing member 500 is disposed as a long rectangular and planar protrusion along the X direction, and the infusion tube pressing member 500 is in a position facing the liquid feeding drive unit 60.
  • the infusion tube pressing member 500 has a flat surface in the X direction along the liquid feeding drive unit 60, and the infusion tube pressing member 500 closes the opening / closing cover 5 in the CR direction, A part of the infusion tube 200 is pressed between them.
  • the medical worker can set the infusion tube 200 on the lower half of the body of the infusion pump 1 along the horizontal direction while confirming the display content displayed on the display unit 3, and the infusion tube 200 is connected to the tube mounting portion. After being set to 50, the opening / closing cover 5 can cover the infusion tube 200.
  • the first hook member 5D and the second hook member 5E are mechanically simultaneously engaged with the fixing portions 1D and 1E on the lower body 1B side, so that the open / close cover 5 is As shown, the tube mounting part 50 of the main body lower part 1B is held in a closed state.
  • the first hook member 5D, the second hook member 5E, and the fixing portions 1D, 1E on the main body lower part 1B side constitute a double hook structure portion 300 of the opening / closing cover 5.
  • the tube clamp part 270 shown in FIG. 3 clamps and closes the middle part of the infusion tube 200 by closing the open / close cover 5.
  • the tube clamp portion 270 is disposed in the vicinity of the left fixed portion 1E and at a position corresponding to the left second hook member 5E.
  • the tube clamp portion 270 can block a part of the infusion tube 200 in the middle.
  • the first infusion tube guide portion 54 is provided on the right side of the main body lower portion 1B, and the second infusion tube guide portion 55 is provided on the left side of the main body lower portion 1B.
  • the first infusion tube guide portion 54 can be held by fitting the upstream side 200A of the infusion tube 200
  • the second infusion tube guide portion 55 can be held by fitting the downstream side 200B of the infusion tube 200
  • the infusion tube 200 can be held. It is held in the horizontal direction along the X direction.
  • the infusion tube 200 held in the horizontal direction is in the T direction along the bubble sensor 51, the upstream block sensor 52, the liquid feed drive unit 60, the downstream block sensor 53, and the tube clamp unit 270. It is fixed by fitting along.
  • the second infusion tube guide portion 55 is a groove portion formed in the side surface portion 1 ⁇ / b> S of the main body lower portion 1 ⁇ / b> B in order to detachably hold a part of the downstream side 200 ⁇ / b> B of the infusion tube 200. is there.
  • the first infusion tube guide portion 54 and the second infusion tube guide portion 55 are provided in the tube attachment portion 50 so that the infusion tube 200 is not sandwiched between the opening / closing cover 5 and the tube attachment portion 50 and crushed. Can be installed securely.
  • the bubble sensor 51 shown in FIG. 3 is a sensor that detects bubbles (air) generated in the infusion tube 200.
  • the bubble sensor 51 is an ultrasonic sensor that monitors bubbles contained in the medicine flowing into the infusion tube 200 from the outside of the infusion tube 200 formed of a thermoplastic resin such as polybutadiene.
  • the bubble sensor 51 includes a pressing member 320 and a receiving member 330 shown in FIG. As shown in FIG. 4, the pressing member 320 is disposed on the inner surface of the opening / closing cover 5.
  • the receiving member 330 is disposed on the main body cover 2.
  • FIG. 4 shows an electrical configuration example of the infusion pump 1.
  • the pressing member 320 and the receiving member 330 can sandwich a part of the infusion tube 200 with the pressing member 32 and the receiving member 330 facing each other.
  • the ultrasonic oscillator 321 is disposed on the pressing member 320, and the ultrasonic receiver 331 is disposed on the receiving member 330.
  • the ultrasonic wave generated from the ultrasonic wave oscillator 321 is received on the ultrasonic wave receiver 331 side. Thereby, the ultrasonic wave oscillating unit 321 applies ultrasonic waves to the medicine 171 flowing in the infusion tube 200.
  • the sound wave receiving unit 331 detects a difference between the ultrasonic wave transmittance of the medicine 171 and the ultrasonic wave transmittance caused by the bubble AB, and the ultrasonic wave receiving unit 331 detects the bubble detection signal as shown in FIG. S1 is sent to the control unit 100.
  • the control unit 100 detects the difference in the output signal due to the bubble AB flowing in the infusion tube 200, and the presence or absence of the bubble AB in the drug solution 171 in the infusion tube 200 is detected by the bubble detection signal S1. It comes to monitor.
  • the control unit 100 corresponds to the size of the bubble AB (the length mm in the infusion tube 200 depending on the length of time for detecting the bubble AB flowing in the infusion tube 200. Is detected).
  • the upstream blockage sensor 52 shown in FIG. 3 is a sensor that detects whether or not the inside of the infusion tube 200 is blocked on the upstream side 200 ⁇ / b> A of the infusion tube 200. It is a sensor that detects whether or not the inside of the infusion tube 200 is closed on the downstream side 200B of the tube 200.
  • the upstream blockage sensor 52 and the downstream blockage sensor 53 have the same configuration.
  • the case where the infusion tube 200 is blocked is, for example, a case where the viscosity of the medicine to be delivered is high or the concentration of the medicine is high.
  • pressing members 452 and 453 are provided on the inner surface side of the opening / closing cover 5 at positions corresponding to the upstream closing sensor 52 and the downstream closing sensor 53, respectively.
  • the upstream occlusion sensor 52 and the downstream occlusion sensor 53 are infused by closing the open / close cover 5.
  • the closed state of the tube 200 can be detected.
  • the infusion pump 1 has a control unit 100 that determines and controls the operation of the entire infusion pump 1.
  • the liquid feeding drive unit 60 includes a drive motor 61, a cam structure 62 having a plurality of cams driven to rotate by the drive motor 61, and a plurality of fingers moved by the cams of the cam structure 62.
  • a finger structure 63 is provided.
  • the cam structure 62 has a plurality of cams, for example, a plurality of cams 62A to 62F, and the finger structure 63 has a plurality of fingers 63A to 63F corresponding to the plurality of cams 62A to 62F.
  • the plurality of cams 62A to 62F are arranged with a phase difference from each other, and the cam structure 62 is connected to an output shaft (also referred to as a cam shaft) 61A of the drive motor 61.
  • the plurality of fingers 63A to 63F sequentially advance and retreat by a predetermined stroke in the Y direction, so that the infusion tube 200 extends along the T direction. Then, it is pressed against the infusion tube pressing member 500 of the opening / closing cover 5. For this reason, the medicine in infusion tube 200 can be sent in the T direction. That is, when the plurality of fingers 63A to 63F are individually driven, the plurality of fingers 63A to 63F sequentially press the outer peripheral surface of the infusion tube 200 along the T direction to feed the medicine in the infusion tube 200. .
  • control unit 100 controls the peristaltic motion of the plurality of fingers 63A to 63F, thereby causing the fingers 63A to 63F to move forward and backward in sequence, so that the wave travels, so that the blockage point of the infusion tube 200 is set.
  • the infusion tube 200 is squeezed and the medicine is fed into the blood vessel of the patient P through the indwelling needle 172.
  • the control unit 100 in FIG. 4 employs a CPU (central control unit) chip.
  • the control unit 100 uses, for example, a one-chip microcomputer to control the overall operation, and includes a ROM (read only memory) 101, a RAM (random access memory) 102, a nonvolatile memory 103, and a clock. 104.
  • the clock 104 can correct the current time by a predetermined operation, and can acquire the current time, measure the elapsed time of a predetermined liquid feeding operation, measure the reference time of liquid feeding speed control, and the like.
  • the controller 100 determines that bubbles larger than a predetermined bubble size are generated in the infusion tube 200, or when the total volume of the generated bubbles reaches a predetermined volume value, the infusion pump 1 driving motor 61 can be stopped, and the liquid feeding operation of the medicine can be stopped.
  • the display unit 3 the speaker 131, the buzzer 132, and the lamp 4A are generated when bubbles larger than a predetermined bubble size are generated in the infusion tube 200 or the total number of bubbles generated.
  • the volume reaches a predetermined volume value, it is a warning means that can issue a warning (the lamp 4A is lit or blinks in red) to a medical worker by a command from the control unit 100.
  • the medical worker can immediately recognize that there is a possibility that the patient's body may be affected by the generation of bubbles in the infusion tube 200 and entering the blood vessels of the patient. Then, the subsequent measures can be performed quickly.
  • the switch 111 in FIG. 4 supplies power to the control unit 100 from one of the power converter unit 112 and the battery 113 by switching between the power converter unit 112 and the battery 113.
  • the power converter unit 112 is connected to a commercial AC power source 115 via an outlet 114.
  • the battery 113 is a rechargeable secondary battery such as a lithium ion battery. As shown in FIG. 4, when the infusion pump 1 is placed in a ward, for example, the information terminal 600 on the nurse center side is placed in the nurse center 650 distant from the infusion pump 1, and the display unit 3 described above.
  • Lamp 4A speaker 131
  • display unit 3T similar to that of buzzer 132, lamp WT (formed of LED, etc., blinking or lighting green in normal operation, blinking or lighting red in abnormal operation), speaker 131T, buzzer 132T Have.
  • At least one or all of the display unit 3T, the speaker 131T, the buzzer 132T, and the lamp 3WT are generated when bubbles larger than a predetermined bubble size are generated in the infusion tube 200 or within a predetermined time (minute).
  • This is a warning means that can issue a warning to a medical worker by a command from the control unit 100 when the total volume of the air bubbles reached a predetermined value.
  • the medical staff in the nurse center 650 can immediately recognize that bubbles may be generated in the infusion tube 200 and the bubbles may enter the patient's blood vessels, which may affect the patient's body. The health care worker can then quickly deal with it.
  • the display unit driver 130 in FIG. 4 drives the display unit 3 according to a command from the control unit 100 and displays a warning message. Thereby, the possibility that a medical worker can visually recognize is increased.
  • the error display lamp 4 ⁇ / b> A is lit in red according to a command from the control unit 100.
  • the speaker 131 can notify various warning contents by voice according to the command of the control unit 100.
  • the buzzer 132 can warn various warnings by sound according to a command from the control unit 100.
  • the display unit 3T is driven by a command from the control unit 100 to display a warning message, thereby increasing the possibility that a medical worker can visually recognize.
  • the error display lamp 4 ⁇ / b> A is lit in red according to a command from the control unit 100.
  • the speaker 131T can notify various warning contents by voice according to the command of the control unit 100.
  • the buzzer 132T can warn various warnings by sound according to a command from the control unit 100.
  • a downstream block signal S3 indicating that the side is blocked is supplied to the control unit 100.
  • the upstream blockage sensor 52 and the downstream blockage sensor 53 can detect a state in which the internal pressure of the infusion circuit exceeds the set pressure in the infusion pump 1 and the medicine cannot be delivered.
  • the reason why the internal pressure of the infusion circuit exceeds the set pressure in the infusion pump 1 is that there is a so-called “needle detachment” in which the tip of the infusion needle 172 for infusion shown in FIG.
  • needle detachment in which the tip of the infusion needle 172 for infusion shown in FIG.
  • the inside of the tube 200 is clogged and clogged, a part of the infusion tube 200 is crushed or broken, or a high-viscosity drug is used.
  • the control unit 100 can communicate bidirectionally with a computer 141 such as a desktop computer through a communication port 140.
  • the computer 141 is connected to a drug database (DB) 160, and the drug library MF stored in the drug database 160 is acquired by the control unit 100 via the computer 141 as necessary, and the control unit 100 100 nonvolatile memories 103 can be stored.
  • the control unit 100 can display the drug library MF and the like on the display unit 3 shown in FIG. 2, for example, based on the stored drug library MF.
  • the drug library MF includes upper and lower limit values of various parameters (scheduled injection volume mL, injection volume mL / h, etc.) related to drug names, drug manufacturers, drug administration, etc., contraindication information, and the like.
  • FIG. 5 is a flowchart showing an example of use of the infusion pump 1.
  • step ST1 of FIG. 5 when a medical worker opens the opening / closing cover 5 and sets the infusion tube 200 in the tube mounting portion 50 as shown in FIG. 3, the infusion tube is viewed by looking at the infusion tube setting direction display portion 150. The set direction of 200 is visually confirmed.
  • the medical staff places the upstream side 200A of the infusion tube 200 on the first infusion tube guide part 54 side of the right side toward the main body part 1B, and faces the downstream side 200B of the infusion tube 200 in the main body part 1B. And placed on the second infusion tube guide 55 side of the left side portion.
  • the medical staff can replace the infusion tube 200 with the first infusion tube guide portion 54, the bubble sensor 51, the upstream occlusion sensor 52, the liquid feeding drive portion 60, the downstream occlusion sensor 53, the tube clamp portion 270, and It can be set in the T direction along the second infusion tube guide portion 55.
  • the open / close cover 5 is closed to cover the bubble sensor 51, the upstream block sensor 52, the downstream block sensor 53, the liquid feeding drive unit 60, and the tube clamp unit 270.
  • the infusion tube 200 can be set along the T direction which is the correct direction, and the infusion pump 1 can feed the drug along the T direction through the infusion tube 200 by driving the infusion driving unit 60. The action can be performed.
  • the bubble detection signal S ⁇ b> 1 is converted into a digital value by analog / digital conversion, and the presence or absence of the bubble AB in the drug solution 171 in the infusion tube 200 is monitored.
  • the time interval at which the control unit 100 monitors the bubble detection signal S1 of the bubble sensor 51 is, for example, 50 mS, but is not limited thereto.
  • the control unit 100 monitors the bubble detection signal S1 of the bubble sensor 51 to monitor the presence or absence of passage of the bubble AB the bubble sensor 51 passes the bubble AB.
  • the control unit 100 determines that “there is a bubble”.
  • the control unit 100 determines that “there is a bubble” if the analog / digital value of the bubble detection signal S1 is equal to or less than a predetermined analog / digital conversion value (AD value) threshold. That is, since the bubble AB absorbs ultrasonic waves compared to the medicine 171, if the bubble AB passes through the bubble sensor 51, the analog / digital conversion value decreases. From this, the control unit 100 can confirm the passage of the bubble AB when the analog-digital conversion value of the bubble detection signal S1 is equal to or less than a predetermined threshold of the analog-digital conversion value.
  • AD value analog / digital conversion value
  • step ST4 the control unit 100 measures the bubble detection size from the bubble detection signal S1.
  • the threshold value of the size of the bubble AB detected by the bubble sensor 51 is, for example, a length of 5 mm or more in the traveling direction of the medicine.
  • the threshold corresponds to a bubble having a volume of 0.04 mL.
  • the control unit 100 measures the size of the bubble AB based on the time during which the bubble passes.
  • the control unit 100 measures the size of the bubble AB based on the time during which the analog-digital conversion value of the bubble detection signal S1 is equal to or less than a predetermined threshold of the analog-digital conversion value and the flow rate of the medicine. .
  • step ST5 when it is determined that the size of the bubble AB detected by the bubble sensor 51 is equal to or longer than the length of approximately 5 mm (the volume of the bubble AB corresponds to 0.04 mL) in the traveling direction of the medicine. Since the patient's body may be affected, the control unit 100 immediately determines that it is necessary to stop the liquid feeding operation of the medicine.
  • step ST6-1 the control unit 100 in FIG.
  • the size of the bubble AB that can be measured by the control unit 100 using the bubble sensor 51 is 5 mm or more.
  • the control unit 100 uses the bubble sensor 51 to control, for example, a minute bubble having a length of 1 mm to less than 5 mm (0.008 mL to 0.00 mm). (Corresponding to bubbles having a volume of less than 04 mL) can be confirmed.
  • the control unit 100 stops the liquid feeding operation of the medicine and at the same time issues a warning to the medical staff that the detected size of the bubbles is approximately 5 mm or more.
  • the display unit driver 130 in FIG. 4 drives the display unit 3 according to a command from the control unit 100 and displays an alarm message indicating that “a bubble larger than a predetermined size has been detected”. Thereby, the possibility that a medical worker can visually recognize is increased.
  • the error display lamp 4 ⁇ / b> A in FIG. 4 is lit in red according to a command from the control unit 100.
  • the speaker 131 can notify various alarm contents by voice according to a command from the control unit 100.
  • the buzzer 132 can give various warnings by sound according to a command from the control unit 100.
  • the display unit 3T is driven by an instruction from the control unit 100 to display an alarm message indicating that a bubble larger than a predetermined size has been detected. Thereby, the possibility that a medical worker can visually recognize is increased.
  • the error display lamp 3WT is lit in red according to a command from the control unit 100.
  • the speaker 131T can notify various alarm contents by voice according to a command from the control unit 100.
  • the buzzer 132T can give various warnings by sound according to the command of the control unit 100.
  • the bubble sensor 51 when returning to step ST5 in FIG. 5, the bubble sensor 51 is less than the size of the bubble AB whose size can be measured, that is, the detection size of the bubble AB is less than 5 mm, for example, the length is 1 mm to 4 mm. If there is a bubble size that can be counted by accumulating the number of detected bubbles in step ST7, in step ST8, the output shaft (cam shaft) 61A of the drive motor 61 in FIG. The number of bubbles is accumulated and counted over time by the accumulation method illustrated in FIG.
  • FIG. 6 shows an example of a method in which the control unit 100 accumulates and counts the number of bubbles by the rotation of the output shaft (cam shaft) 61A. Bubbles having a length of 5 mm or more are simply called bubbles, but bubbles having a length of less than 5 mm are called minute bubbles.
  • the number of minute bubbles AB (for example, AB1 to AB9) having a length less than about 5 mm is detected during a plurality of rotations of the output shaft (cam shaft) 61A, and the number of bubbles AB is accumulated. Shows how to get quantity.
  • FIG. 6 shows an example of a method in which the control unit 100 accumulates and counts the number of bubbles by the rotation of the output shaft (cam shaft) 61A. Bubbles having a length of 5 mm or more are simply called bubbles, but bubbles having a length of less than 5 mm are called minute bubbles.
  • the number of minute bubbles AB (for example, AB1 to AB9) having a length less
  • the sections corresponding to one rotation of the output shaft (cam shaft) 61A are sections (position RV0-position RV1), sections (position RV1-position RV2), ... (omitted), ... section (position RV10).
  • ⁇ Position RV11) is indicated by a broken line.
  • a minute bubble AB1 is detected in the section (position RV0-position RV1), and one minute bubble AB2 is detected in the section (position RV1-position RV2). That is, in the section (position RV0 ⁇ position RV1) and the section (position RV1 ⁇ position RV2), the minute bubbles AB1 and AB2 are detected across the line, but the control unit 100 in FIG. Count as two small bubbles AB1, AB2. In the next section (position RV2-position RV3), since the minute bubbles are not detected, the control unit 100 does not count the minute bubbles. In the section (position RV3 ⁇ position RV4), two minute bubbles AB3 are detected separately and continuously.
  • the control unit 100 counts as one minute bubble AB3 even if two minute bubbles AB3 are detected. In the section (position RV4 ⁇ position RV5), the control unit 100 counts one minute bubble AB4.
  • a minute bubble AB5 is detected, and in the section (position RV6-position RV7), one minute bubble AB6 is detected. That is, in the section (position RV5-position RV6) and the section (position RV6-position RV7), the control unit 100 counts a total of two minute bubbles AB5, AB6.
  • the minute bubble ABN is smaller than the bubble ABM having a predetermined size that is not counted, and therefore the control unit 100 does not count the minute bubble ABN.
  • the bubble ABM having a predetermined size not counted is, for example, 1.5 mm, but is not particularly limited and can be arbitrarily set.
  • control unit 100 counts one minute bubble AB7.
  • control unit 100 counts one minute bubble AB8.
  • control unit 100 counts one minute bubble AB9.
  • the control unit 100 makes a minute change in 25 seconds after the output shaft (cam shaft) 61A starts rotating. A total of nine bubbles, bubbles AB1 to AB9, are accumulated.
  • the volume of one minute bubble AB is determined in advance, and the control unit 100 can calculate the approximate amount of the volume of the bubble from the volume of the one minute bubble AB ⁇ the number of bubbles. it can.
  • the control unit 100 calculates the cumulative amount of the bubble volume, and determines that the cumulative amount of the bubble has reached approximately 1 mL or more, which is a threshold value of the cumulative volume amount, for example, in a measurement time of 15 minutes. Then, assuming that there is a possibility of affecting the patient's body, the control unit 100 moves to step ST10-1 and step ST10-2 in FIG.
  • the control unit 100 obtains the cumulative amount of the volume of the bubble by the volume of one minute bubble AB ⁇ the number of bubbles, and this cumulative amount is, for example, a threshold value for the cumulative amount of volume in the measurement time of 15 minutes.
  • the cumulative value calculation method of the bubble AB that is determined to have reached approximately 1 mL or more is adopted.
  • the control unit 100 uses a predetermined threshold for the cumulative amount of volume. It is judged whether it reaches about 1mL or more.
  • the accuracy of calculation of the accumulated value of the bubbles AB is slightly lowered, but the size of the minute bubbles AB is measured, the number of the minute bubbles AB is accumulated, and the accumulated amount of the volume of the bubbles is a threshold value. It is possible to reduce the processing time for confirming whether or not approximately 1 mL has been exceeded, and to reduce the risk that bubbles cannot be detected.
  • step ST10-1 the control unit 100 in FIG. 4 immediately stops the operation of the drive motor 61 to stop the liquid feeding operation of the medicine. Moreover, the control unit 100 stops the liquid feeding operation of the medicine and at the same time issues an alarm to the medical staff.
  • step ST10-2 the display unit driver 130 in FIG. 4 drives the display unit 3 according to a command from the control unit 100 to display an alarm message. Thereby, the possibility that a medical worker can visually recognize is increased.
  • the error display lamp 4 ⁇ / b> A in FIG. 4 is lit in red according to a command from the control unit 100.
  • the speaker 131 can notify various alarm contents by voice according to a command from the control unit 100.
  • the buzzer 132 can give various warnings by sound according to a command from the control unit 100.
  • the display unit 3T is driven by an instruction from the control unit 100 to display an alarm message. Thereby, the possibility that a medical worker can visually recognize is increased.
  • the error display lamp 3WT is lit in red according to a command from the control unit 100.
  • the speaker 131T can notify various alarm contents by voice according to a command from the control unit 100.
  • the buzzer 132T can give various warnings by sound according to the command of the control unit 100.
  • An infusion pump 1 is an infusion pump for delivering a medicine to a patient using an infusion tube, and detects a bubble generated in the infusion tube when the medicine is delivered. And a drive motor for feeding the drug in the infusion tube to the patient side, and if the bubble size is greater than or equal to a predetermined size based on the bubble detection signal of the bubble sensor, the drive motor is stopped to feed the drug. When the operation is stopped and the bubble size is smaller than the predetermined size, the total volume of the counted number of bubbles reaches a predetermined threshold within a predetermined time. Then, the control part which stops a drive motor and stops the liquid feeding operation
  • control unit can stop the liquid feeding operation of the medicine when the bubble size is equal to or larger than the predetermined size, and even if the bubble size is less than the predetermined size, When the total volume of the counted number of bubbles reaches a predetermined threshold value within a predetermined time, the liquid feeding operation of the medicine can be stopped. Thereby, when air bubbles are contained in the liquid medicine in the infusion tube, the influence on the patient's body can be prevented by stopping the liquid feeding of the medicine.
  • the alarm means sends a command from the control unit when the total volume of the counted bubbles reaches a threshold value and stops the liquid feeding operation of the medicine by stopping the drive motor. Generates an alarm.
  • the control unit is a case where the size of the bubble is less than a predetermined size, and the total volume of the counted number of bubbles reaches a predetermined threshold within a predetermined time, and the liquid delivery of the medicine An alarm can be generated when the operation is stopped. For this reason, the medical worker can recognize that the liquid feeding operation of the medicine has been stopped and can quickly perform the subsequent countermeasures.
  • the predetermined size of the bubble is 5 mm in length (corresponding to a bubble with a volume of 0.04 mL). Therefore, if there is a bubble with a length of 5 mm or more, the liquid feeding operation of the medicine is stopped. , Can prevent the impact on the patient's body. Since the threshold value is 1 mL, the size of the bubbles does not reach the predetermined size, but when the total volume of the counted bubbles reaches the threshold value of 1 mL, the liquid feeding operation of the medicine is stopped. , Can prevent the impact on the patient's body. In the case of drug delivery to a child, this threshold value may be set slightly smaller.
  • the applicable infusion tube and the corresponding bubble length threshold (the inner diameter of the infusion tube varies slightly depending on the manufacturer. (Slightly different) is stored in the storage unit of the infusion pump 1 so that it can be selected and set, or the infusion tube applicable to the computer 160 and the corresponding bubble length threshold are tabulated. If necessary, it may be downloaded to the infusion pump 1.
  • a display unit for displaying information and an operation panel unit having operation buttons are arranged on the upper part of the body of the infusion pump, and an infusion tube for delivering a medicine is arranged on the lower part of the body of the infusion pump. It is an area.
  • the medical worker can perform the liquid feeding operation of the medicine by the infusion pump while confirming the information on the display unit on the upper part of the main body.
  • the medical worker can operate the operation buttons on the operation panel unit while confirming the information on the display unit on the upper part of the main body.

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Emergency Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

[Problème] Fournir une pompe de perfusion qui, en mettant fin à l'administration d'un médicament si des bulles de gaz sont incluses dans un fluide de médicament dans un tube de perfusion, est capable de prévenir les effets sur le corps d'un patient. [Solution] Une pompe de perfusion (1) est pourvue de: un capteur de bulles de gaz (51) qui détecte les bulles de gaz qui apparaissent dans un tube de perfusion (200) lors de l'administration d'un médicament ; un moteur d'entraînement (61) qui administre un médicament (171) dans un tube de perfusion (200) à un côté du patient (P); et une unité de contrôle (100) qui, si, conformément à un signal de détection de bulles de gaz (S1) d'un capteur de bulles de gaz, la taille des bulles de gaz (AB) est supérieure ou égale à une taille prédéfinie, stoppe le moteur d'entraînement (61) pour mettre fin à l'opération d'administration du médicament, et si la taille des bulles de gaz (AB) est inférieure à la taille prédéfinie, compte le nombre de bulles de gaz (AB), après quoi si le volume total du nombre de bulles comptées atteint un seuil prédéfini dans une quantité prédéfinie de temps, stoppe le moteur d'entraînement (61) pour mettre fin à l'opération d'administration du médicament.
PCT/JP2012/006212 2012-09-27 2012-09-27 Pompe de perfusion WO2014049656A1 (fr)

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PCT/JP2012/006212 WO2014049656A1 (fr) 2012-09-27 2012-09-27 Pompe de perfusion

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CN112107760A (zh) * 2019-06-20 2020-12-22 深圳迈瑞科技有限公司 一种输液泵工作方法、输液泵、医疗设备及存储介质
CN112107758A (zh) * 2019-06-20 2020-12-22 深圳迈瑞科技有限公司 一种输液泵工作方法、输液泵、医疗设备及存储介质
WO2021202359A1 (fr) * 2020-03-31 2021-10-07 Bayer Healthcare Llc Système de correction de volume d'air basé sur la pression et le débit de fluide

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US11846279B2 (en) 2021-01-29 2023-12-19 Masterflex, Llc Accurate volume dispensing using pump and flow sensor
US11920581B2 (en) 2021-01-29 2024-03-05 Masterflex Llc Flow rate control for pump with flow sensor

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CN112107760A (zh) * 2019-06-20 2020-12-22 深圳迈瑞科技有限公司 一种输液泵工作方法、输液泵、医疗设备及存储介质
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WO2021202359A1 (fr) * 2020-03-31 2021-10-07 Bayer Healthcare Llc Système de correction de volume d'air basé sur la pression et le débit de fluide

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