WO2014162359A1 - Dispositif de circulation extracorporelle, et procédé de commande et support d'enregistrement pour dispositif de circulation extracorporelle - Google Patents

Dispositif de circulation extracorporelle, et procédé de commande et support d'enregistrement pour dispositif de circulation extracorporelle Download PDF

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Publication number
WO2014162359A1
WO2014162359A1 PCT/JP2013/002373 JP2013002373W WO2014162359A1 WO 2014162359 A1 WO2014162359 A1 WO 2014162359A1 JP 2013002373 W JP2013002373 W JP 2013002373W WO 2014162359 A1 WO2014162359 A1 WO 2014162359A1
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WO
WIPO (PCT)
Prior art keywords
extracorporeal circulation
circulation device
power supply
emergency transport
emergency
Prior art date
Application number
PCT/JP2013/002373
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English (en)
Japanese (ja)
Inventor
知樹 櫨田
強 長谷川
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 PCT/JP2013/002373 priority Critical patent/WO2014162359A1/fr
Publication of WO2014162359A1 publication Critical patent/WO2014162359A1/fr

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    • 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
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/367—Circuit parts not covered by the preceding subgroups of group A61M1/3621
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/82—Internal energy supply devices
    • A61M2205/8206—Internal energy supply devices battery-operated
    • A61M2205/8212—Internal energy supply devices battery-operated with means or measures taken for minimising energy consumption

Definitions

  • the present invention relates to an extracorporeal circulation device, a control method for the extracorporeal circulation device, and a storage medium.
  • Patent Literature 1 discloses an extracorporeal circulation device that automatically adjusts the circulation state.
  • the extracorporeal circulation device is mainly used for cardiac surgery or the like in a hospital, but is also provided in an ambulance vehicle to send blood to a patient in an emergency.
  • the extracorporeal circulation device is normally connected to an AC power source in a room such as a hospital, and thus operates while charging the battery.
  • a room such as a hospital
  • the extracorporeal circulation device is normally connected to an AC power source in a room such as a hospital, and thus operates while charging the battery.
  • the power supply is limited and the supply becomes unstable. It is necessary to operate with minimum power consumption.
  • an object of the present invention is to provide an extracorporeal circulation device that effectively utilizes a limited power supply during emergency transport.
  • An extracorporeal circulation apparatus that achieves the above object is as follows.
  • An extracorporeal circulation device for circulating the blood of a subject outside the body Determination means for determining the stability of a power supply state from an external power source to the extracorporeal circulation device; When the power supply state is determined to be unstable by the determination means, it is determined that the emergency transport is being performed, and the emergency operation that operates while reducing the power consumption from the normal mode that operates without reducing the power consumption.
  • FIG. 1 is a diagram illustrating an example of the overall configuration of the extracorporeal circulation device 100 according to the first embodiment of the present invention.
  • the extracorporeal circulation device 100 is used not only for extracorporeal circulation such as cardiac surgery but also for auxiliary circulation procedures such as PCPS (percutaneous cardiopulmonary support) and ECMO (extracorporeal membrane oxygenation), and performs cardiopulmonary assist operations (extracorporeal circulation operation, priming operation). Do.
  • the extracorporeal circulation apparatus 100 has a blood extracorporeal circuit (hereinafter referred to as a circulation circuit) indicated by an arrow in the figure. In the extracorporeal circulation apparatus 100, after performing the priming operation, the blood of the subject 130 is circulated extracorporeally using this circulation circuit.
  • the priming operation refers to an operation of removing the bubbles in the circuit by circulating the priming solution in the circulation circuit in a state where the circulation circuit is sufficiently filled with the priming solution (for example, physiological saline).
  • the priming solution for example, physiological saline
  • the extracorporeal circulation device 100 includes a controller 110 that functions as a control device, a drive motor 111, a centrifugal pump 112, an oxygenator 113, an oxygen supply source 117, a catheter (venous side) 119, and a catheter (arterial side) 120.
  • the catheter (arterial side) 120 pumps blood toward the body of the subject 130, and the catheter (venous side) 119 performs blood removal from the body of the subject 130.
  • the centrifugal pump 112 is also called a centrifugal artificial heart, drives a rotating body provided inside, applies pressure to the blood, and circulates the blood in the circulation circuit.
  • the drive motor 111 gives a rotational driving force to the rotating body of the centrifugal pump 112.
  • the pressure in the circulation circuit before being pressurized by the centrifugal pump 112 is detected by the pressure sensor 123.
  • the artificial lung 113 performs blood circulation and blood gas exchange (oxygen addition, carbon dioxide removal, etc.).
  • the oxygen supply source 117 is realized by, for example, an oxygen cylinder and supplies oxygen to be added to blood.
  • the oxygen supplied from the oxygen supply source 117 is used at the time of gas exchange by the artificial lung 113.
  • the bubble sensor 114 detects bubbles contained in the priming liquid (or blood) flowing in the circulation circuit during the priming operation (or during the extracorporeal circulation operation) by a predetermined detection method (ultrasonic wave, light, etc.).
  • the blood filter 116 filters blood or removes bubbles in the blood.
  • the flow sensor 115 includes, for example, a built-in ultrasonic transceiver, and detects the flow rate of the priming liquid (or blood) in the circulation circuit.
  • the clamp 122 is a member for closing the tube so as to forcibly stop the blood supply toward the body of the subject 130 during the extracorporeal circulation operation.
  • the clamp 122 performs blood feeding based on a manual mode in which a medical worker performs an occlusion operation by inputting an occlusion instruction on the controller 110 and output signals from the bubble sensor 114, the flow sensor 115, the pressure sensor 123, and the like.
  • a manual mode in which a medical worker performs an occlusion operation by inputting an occlusion instruction on the controller 110 and output signals from the bubble sensor 114, the flow sensor 115, the pressure sensor 123, and the like.
  • the branch line 118 switches the flow path of the circulation circuit. Specifically, when the blood of the subject 130 is circulated extracorporeally, a circulation circuit passing through the body of the subject 130 is constructed as shown in 1A of FIG. Circulate. During the priming operation, as shown in 1B of FIG. 1, the circuit of the circulation circuit to the inside of the body of the subject 130 is blocked by the branch line 118 (in other words, the circulation circuit that passes only the outside of the subject 130 (in other words, the subject A circulation circuit that does not pass through the body of the person 130 is constructed, and the circulation circuit is filled with the priming liquid (without passing through the body of the subject) to circulate the priming liquid.
  • one or a plurality of bubble discharge ports for discharging bubbles are provided on the circulation circuit.
  • the bubbles in the circulation circuit are circulated. It will be discharged from the bubble discharge port.
  • the controller 110 comprehensively controls the extracorporeal circulation operation and the priming operation in the extracorporeal circulation device 100.
  • the centrifugal motor 112 is driven by controlling the drive motor 111, or the gas exchange operation is performed by controlling the artificial lung 113.
  • the bubble sensor 114 is controlled to acquire an output signal from the bubble sensor 114, and the flow rate sensor 115 and the pressure sensor 123 are controlled to acquire a flow rate value and a pressure value. Further, when an abnormality that requires blood supply to be stopped is detected based on output signals from the bubble sensor 114, the flow sensor 115, and the pressure sensor 123, the clamp 122 is closed.
  • the controller 110 controls the execution of the priming operation.
  • a circulation circuit that does not pass through the body of the subject 130 is constructed by the branch line 118 as shown in 1B of FIG.
  • the priming liquid supply source 121 is connected to the branch line 118, and the priming liquid is supplied from the priming liquid supply source 121 into the circulation circuit.
  • the circulation circuit is filled with the priming liquid.
  • the centrifugal pump 112 is driven by the control of the controller 110, and the priming liquid circulates in the circulation circuit a plurality of times. Bubbles in the circulation circuit are discharged from the bubble discharge port or the like with this circulation. At this time, bubbles in the circulation circuit are detected by the bubble sensor 114, and the controller 110 determines whether or not there are bubbles contained in the circulation circuit and the size of the bubbles based on the detection result of the bubble sensor 114. .
  • the controller 110 when the result of the determination satisfies a predetermined standard, the priming operation is terminated. At the end of this, the controller 110 notifies the user that the priming operation has ended using a display (not shown), a speaker (not shown), or the like. The user who receives the notification of the end of the priming operation switches the branch line 118 and constructs a circulation circuit that passes through the body of the subject 130 as shown in 1A of FIG. Thereby, the blood of the subject 130 is circulated extracorporeally.
  • blood that has been removed from the catheter (vein side) 119 enters the oxygenator 113 via the centrifugal pump 112.
  • gas exchange that is, processing such as oxygen addition and carbon dioxide removal is performed.
  • the filtered blood is sent from the catheter (arterial side) 120 into the body of the subject 130 through the blood filter 116 and the like. This process from blood removal to blood transfer is repeated, and the blood of the subject 130 is circulated extracorporeally.
  • the controller 110 includes a display unit 203, an operation unit 202, a storage unit 201, an I / F unit 206, a timer unit 204, a communication unit 207, and a control unit (computer) 205 as functional configurations. .
  • the display unit 203 is realized by, for example, a display such as a monitor (including an output unit that outputs an alarm sound), and displays various types of information to the user.
  • the operation unit 202 is realized by various buttons, for example, and inputs an instruction from a medical worker. Part or all of the display unit 203 and the operation unit 202 may be realized as a touch panel with an audio speaker, for example.
  • the storage unit 201 is realized by, for example, a storage medium such as a hard disk and stores various types of information. Further, a program for executing the processing according to the present invention is stored.
  • the I / F unit 206 exchanges various signals with an external device. Note that output signals from the bubble sensor 114, the flow sensor 115, and the pressure sensor 123 are taken into the controller 110 via the I / F unit 206.
  • the timer unit 204 measures various times.
  • the communication unit 207 communicates with the communication unit 211 attached to the medical staff.
  • the communication between the communication unit 207 and the communication unit 211 may be short-range wireless communication such as Bluetooth (registered trademark) or wireless communication using a wireless LAN such as Wi-Fi.
  • the control unit 205 includes, for example, a CPU (Central Processing Unit), a ROM (Read Only Memory), a RAM (Random Access Memory), and the like, and realizes the above-described cardiopulmonary assist operation and the emergency transport determination process described below. It is assumed that a program for storing the information is stored (the description is omitted here).
  • a CPU Central Processing Unit
  • ROM Read Only Memory
  • RAM Random Access Memory
  • the functional configuration of the controller 110 is merely an example, and a new configuration may be added, or unnecessary configuration may be omitted as appropriate.
  • the storage unit 201 (such as a hard disk) is not necessarily provided and may be omitted.
  • the extracorporeal circulation apparatus 100 can operate by switching between a normal mode that operates without reducing power consumption and an emergency conveyance mode that operates while reducing power consumption during emergency conveyance.
  • FIG. 6 is a diagram illustrating an example of a switching condition between the normal mode and the emergency transport mode.
  • Reference numeral 601 denotes a control object
  • reference numeral 602 denotes control contents in the normal mode
  • reference numeral 603 denotes control contents in the emergency transport mode.
  • the controller 110 receives power from the power cable and controls to charge until the battery reaches 100%.
  • the battery is not charged, or the minimum predetermined amount required for transporting the patient from the emergency vehicle to a hospital bed (15-20 minutes operable state, battery capacity) However, it is controlled to charge only up to 30%, for example.
  • the extracorporeal circulation device 100 can perform pulsation drive.
  • the pulsation drive is a drive in which the controller 110 controls the drive motor 111 to periodically increase or decrease the number of rotations so that blood can easily reach the periphery. A pulsation occurs as the rotational speed periodically increases and decreases.
  • the controller 110 performs control so that the pulsation drive can be selected in the normal mode. On the other hand, in the emergency transport mode, control is performed so that selection is not possible because power is consumed.
  • the controller 110 controls the extracorporeal circulation device 100 so as to be selectable even if it is a function that consumes other power but is not essential for life support.
  • the emergency transport mode since power is consumed, control is performed so that the function cannot be selected.
  • the extracorporeal circulation device 100 can operate by switching between the normal mode and the emergency transport mode depending on whether or not the emergency transport is being performed. Detailed processing for this switching will be described with reference to FIG.
  • FIG. 3 is a flowchart illustrating a procedure of emergency conveyance determination processing performed by the extracorporeal circulation device 100 according to the present embodiment.
  • step S301 the controller 110 controls the extracorporeal circulation device 100 to operate in the normal mode.
  • step S302 the controller 110 detects that the extracorporeal circulation device 100 is connected to a power source and AC power feeding is started.
  • the process proceeds to step S303.
  • the power connection is not detected (S302; No)
  • step S303 the controller 110 determines whether or not the power supply state of the AC power supply from the external power source is unstable.
  • the stability of the power supply state is determined based on the change in the AC power supply voltage from the external power supply. For example, when the AC power supply voltage is equal to or lower than the threshold value, it is determined that the power supply state is unstable. Further, it may be determined that the power supply is unstable when AC power supply is repeatedly turned ON / OFF a predetermined number of times within a predetermined time.
  • the process proceeds to step S304.
  • step S308 the process proceeds to step S308.
  • step S304 the controller 110 determines that the subject 130 is in the emergency transport mode, and confirms with the user whether or not the normal mode can be switched to the emergency transport mode. For example, a display asking whether switching is possible is displayed on the display unit 203, and the input of whether the switching is possible is accepted via the operation unit 202.
  • step S305 the controller 110 determines whether switching is permitted by the user. When it is determined that switching is permitted (S305; Yes), the process proceeds to step S306. On the other hand, when it is determined that switching is not permitted (S305; No), the process proceeds to step S308.
  • step S306 the controller 110 switches the extracorporeal circulation device 100 to the emergency transport mode.
  • control such as prohibition of battery charging or impossibility of selection of pulsation drive is performed, and priority is given to power supply to other devices and functions necessary for life support.
  • step S307 the controller 110 notifies the user that the extracorporeal circulation apparatus 100 has been switched to the emergency transport mode (currently operating in the emergency transport mode) by displaying on the display unit 203.
  • the notification method is not necessarily limited to the display on the display unit 203, but voice and sound from a speaker (not shown), light from an LED (not shown) (for example, red when in the emergency transport mode) The LED may be controlled to emit light), or a combination thereof may be used.
  • step S308 the controller 110 operates the extracorporeal circulation device 100 in the normal mode because the power supply state is stable or switching is not permitted by the user. Thus, each process of the flowchart of FIG. 3 is completed.
  • the normal mode and the emergency transport mode are switched according to the stability of the power supply state from the external power source. Therefore, the limited electric power supply during emergency conveyance can be utilized effectively.
  • the configuration in which attention is paid to the power supply state of the AC power supply has been described in order to determine whether or not emergency transport is being performed.
  • the condition for determining whether or not emergency transport is in progress is not limited to the first embodiment.
  • an example will be described in which the normal mode and the emergency transport mode are switched according to the vibration of the extracorporeal circulation device. If the extracorporeal circulation device vibrates, it can be determined that there is a possibility that the extracorporeal circulation device is being used in an emergency vehicle during emergency transport (for example, moving on a road).
  • FIG. 4 is a flowchart illustrating a procedure of emergency conveyance determination processing performed by the extracorporeal circulation device 100 according to the present embodiment.
  • steps S401 to S402 and S406 to S410 the same processes as steps S301 to S302 and S304 to S308 of FIG.
  • step S403 the controller 110 detects the vibration of the extracorporeal circulation device 100.
  • the extracorporeal circulation device 100 is vibrated due to vibrations when an ambulance such as an ambulance or a doctor helicopter moves.
  • the extracorporeal circulation device 100 includes an acceleration sensor (not shown) and detects vibration by the acceleration sensor.
  • step S404 the controller 110 determines whether or not the detected vibration amplitude is greater than or equal to a threshold value. As this threshold value, vibration during movement of the vehicle is measured, and an appropriate value is set in advance.
  • step S404 If it is determined that the amplitude is greater than or equal to the threshold (S404; Yes), the process proceeds to step S405. On the other hand, when it determines with an amplitude being less than a threshold value (S404; No), it progresses to step S410 and operates the extracorporeal circulation apparatus 100 with a normal mode.
  • step S405 the controller 110 determines whether or not the timer unit 204 has continued to vibrate with an amplitude greater than or equal to the threshold value for a predetermined time or more. When it determines with having continued more than predetermined time (S405; Yes), it progresses to step S406 and performs control which switches to emergency conveyance mode. On the other hand, when it determines with having not continued more than predetermined time (S405; No), it progresses to step S410 and operates the extracorporeal circulation apparatus 100 with a normal mode. Thus, the processes in the flowchart of FIG. 4 are completed.
  • the normal mode and the emergency transport mode are switched according to the vibration of the apparatus.
  • the limited electric power supply during emergency conveyance can be utilized effectively.
  • first embodiment and the second embodiment may be combined.
  • switch to the emergency transport mode when both conditions are satisfied AC power supply is unstable and vibration with an amplitude exceeding the threshold continues for a predetermined time. Also good. This makes it possible to determine that the emergency transport is being performed with higher accuracy.
  • the conditions for determining whether or not emergency transport is in progress are not limited to the first and second embodiments.
  • an example will be described in which sound output from an emergency vehicle such as a siren is detected and the normal mode and the emergency transport mode are switched in accordance with the detection.
  • FIG. 5 is a flowchart illustrating a procedure of emergency conveyance determination processing performed by the extracorporeal circulation device 100 according to the present embodiment.
  • steps S501 to S502 and S504 to S508 the same processes as steps S301 to S302 and S304 to S308 in FIG.
  • step S503 the controller 110 determines whether or not a sound output from a rescue vehicle such as a siren is detected. For example, it is determined that the sound output of the siren has been detected when a predetermined overlap condition is satisfied as compared with information of a frequency band specific to the siren held in advance.
  • the process proceeds to step S504, and the extracorporeal circulation device 100 is switched from the normal mode to the emergency transport mode.
  • step S508 the extracorporeal circulation device 100 is operated in the normal mode.
  • the normal mode and the emergency transport mode are switched according to the detection of the sound output of the emergency vehicle.
  • the limited electric power supply during emergency conveyance can be utilized effectively.
  • the first embodiment and the third embodiment may be combined.
  • both the stability of the power supply state and the detection of the sound output are used as the determination criteria, and when both conditions are satisfied (AC power supply is unstable and the sound output of the emergency vehicle is detected), the emergency transport mode may be switched. . This makes it possible to determine that the emergency transport is being performed with higher accuracy.
  • all the determination conditions of the first to third embodiments may be combined. That is, when all the conditions are satisfied (AC power feeding is unstable, vibration detection and sound output from the emergency vehicle are detected), the emergency transport mode may be switched. This makes it possible to determine that the emergency transport is being performed with higher accuracy.
  • the process of automatically determining whether or not the extracorporeal circulation device itself is in emergency transport and switching between the normal mode and the emergency transport mode has been described.
  • the user may manually switch the operation mode of the extracorporeal circulation device.
  • a user such as an ambulance crew directly operates the operation unit 202 (for example, a hard switch) shown in FIG. 2 to switch to the emergency transport mode.
  • switching is performed by a touch operation on the display unit 203.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Cardiology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • External Artificial Organs (AREA)

Abstract

La présente invention concerne un dispositif de circulation extracorporelle assurant la circulation du sang d'un patient à l'extérieur de l'organisme de celui-ci et comprenant une unité de détermination servant à déterminer la stabilité de l'état de l'alimentation électrique, en provenance d'une source d'alimentation extérieure, du dispositif de circulation extracorporelle, et une unité de commande permettant de déterminer qu'un transport d'urgence est en cours lorsque l'unité de détermination détermine que l'état de l'alimentation électrique est instable, et de basculer d'un mode normal de fonctionnement sans réduction de la consommation d'électricité vers un mode de transport d'urgence permettant un fonctionnement avec une consommation d'électricité réduite.
PCT/JP2013/002373 2013-04-05 2013-04-05 Dispositif de circulation extracorporelle, et procédé de commande et support d'enregistrement pour dispositif de circulation extracorporelle WO2014162359A1 (fr)

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PCT/JP2013/002373 WO2014162359A1 (fr) 2013-04-05 2013-04-05 Dispositif de circulation extracorporelle, et procédé de commande et support d'enregistrement pour dispositif de circulation extracorporelle

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2018509974A (ja) * 2015-03-03 2018-04-12 コーニンクレッカ フィリップス エヌ ヴェＫｏｎｉｎｋｌｉｊｋｅ Ｐｈｉｌｉｐｓ Ｎ．Ｖ． 高度除細動器用の適応臨床的利用プロファイル

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS62249655A (ja) * 1986-03-31 1987-10-30 アイシン精機株式会社 補助循環機器駆動装置
JPS63294865A (ja) * 1987-02-27 1988-12-01 ヴァスコー　インコーポレイテッド 生体適合性心室補助および不整脈制御装置
JPH11161344A (ja) * 1997-12-01 1999-06-18 Shadan Aiseikai 機器制御装置
JP2005518503A (ja) * 2002-02-21 2005-06-23 テルモ カーディオバスキュラー システムズ コーポレイション 液体ポンプを制御する方法および装置

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS62249655A (ja) * 1986-03-31 1987-10-30 アイシン精機株式会社 補助循環機器駆動装置
JPS63294865A (ja) * 1987-02-27 1988-12-01 ヴァスコー　インコーポレイテッド 生体適合性心室補助および不整脈制御装置
JPH11161344A (ja) * 1997-12-01 1999-06-18 Shadan Aiseikai 機器制御装置
JP2005518503A (ja) * 2002-02-21 2005-06-23 テルモ カーディオバスキュラー システムズ コーポレイション 液体ポンプを制御する方法および装置

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2018509974A (ja) * 2015-03-03 2018-04-12 コーニンクレッカ フィリップス エヌ ヴェＫｏｎｉｎｋｌｉｊｋｅ Ｐｈｉｌｉｐｓ Ｎ．Ｖ． 高度除細動器用の適応臨床的利用プロファイル

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