WO2013187055A1 - Extracorporeal circulation device and priming method - Google Patents

Extracorporeal circulation device and priming method Download PDF

Info

Publication number
WO2013187055A1
WO2013187055A1 PCT/JP2013/003674 JP2013003674W WO2013187055A1 WO 2013187055 A1 WO2013187055 A1 WO 2013187055A1 JP 2013003674 W JP2013003674 W JP 2013003674W WO 2013187055 A1 WO2013187055 A1 WO 2013187055A1
Authority
WO
WIPO (PCT)
Prior art keywords
priming
priming operation
circulation circuit
extracorporeal circulation
bubbles
Prior art date
Application number
PCT/JP2013/003674
Other languages
French (fr)
Japanese (ja)
Inventor
強 長谷川
知樹 櫨田
悠希 原
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 JP2014520925A priority Critical patent/JP5918364B2/en
Publication of WO2013187055A1 publication Critical patent/WO2013187055A1/en

Links

Images

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
    • 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
    • A61M1/3643—Priming, rinsing before or after use
    • 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
    • A61M1/3643—Priming, rinsing before or after use
    • A61M1/3644—Mode of operation

Definitions

  • the present invention relates to an extracorporeal circulation device and a priming method.
  • an extracorporeal circulation device for example, a cardiopulmonary assist device used for cardiopulmonary assist is known.
  • Such an apparatus includes an extracorporeal blood circulation circuit including an artificial lung, a centrifugal artificial heart (centrifugal pump), a controller, an oxygen supply source (oxygen cylinder), and the like.
  • a priming operation using a priming solution is performed.
  • the priming operation is an operation that bleeds air from the circuit by circulating the priming solution in the circuit at a faster rotational speed than the normal operating speed with the priming fluid sufficiently filling the extracorporeal circuit.
  • air can be removed from the blood extracorporeal circuit (see, for example, Patent Document 1).
  • the user himself / herself determines whether or not air has been sufficiently removed from the blood extracorporeal circuit. Specifically, the end of the priming operation is determined visually or based on the elapsed time from the start of the priming operation.
  • the end determination of the priming operation was performed based on an ambiguous determination criterion that air would be sufficiently removed by the priming operation. For this reason, there has been a concern that the priming operation may be terminated in an unnecessarily long state or in an incomplete state (a state in which air is not completely removed).
  • the present invention has been made in view of the above problems, and an object thereof is to more accurately determine the end of a priming operation.
  • an aspect of the present invention is an extracorporeal circulation device that circulates the blood of a subject outside the body using a circulation circuit, the route of the circulation circuit into the body of the subject.
  • Priming control means for controlling the execution of a priming operation for circulating the priming liquid in the circulation circuit in the shut-off state to remove the bubbles in the circulation circuit, and detecting the bubbles in the circulation circuit during the priming operation Detecting means for determining, the determining means for determining the end of the priming operation based on the time change of the bubble detection result by the detecting means, and when the determining means determines that the priming operation has ended, to that effect And notifying means for notifying the user.
  • the end of the priming operation can be determined more accurately.
  • FIG. 1A is a diagram illustrating an example of the overall configuration of the extracorporeal circulation device 10 according to the first embodiment of the present invention.
  • the extracorporeal circulation device 10 performs a cardiopulmonary assist operation (extracorporeal circulation, auxiliary circulation) used to perform a procedure called PCPS (percutaneous cardiopulmonary support).
  • the extracorporeal circulation device 10 has a blood extracorporeal circuit (hereinafter referred to as a circulation circuit) indicated by an arrow in the figure.
  • a circulation circuit blood extracorporeal circuit
  • the blood of the subject 30 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 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 10 includes a controller 11, a drive motor 12, a centrifugal pump 13, an artificial lung 14, an oxygen supply source 15, a catheter (venous side) 16, a catheter (arterial side) 17, and a bubble sensor. 18, a branch line 19, a blood filter 20, and a flow sensor 21 may be provided. These components are connected by a flexible tube or the like, and the lumen of the tube forms a blood flow path.
  • the catheter (arterial side) 17 pumps blood toward the body of the subject 30, and the catheter (venous side) 16 performs blood removal from the body of the subject 30.
  • the centrifugal pump 13 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 12 applies a rotational driving force to the rotating body of the centrifugal pump 13.
  • the artificial lung 14 performs blood circulation and blood gas exchange (oxygenation, carbon dioxide removal, etc.).
  • the oxygen supply source 15 is realized by, for example, an oxygen cylinder and supplies oxygen to be added to blood.
  • the oxygen supplied from the oxygen supply source 15 is used at the time of gas exchange by the artificial lung 14.
  • the bubble sensor 18 detects bubbles flowing in the circulation circuit during the priming operation by a predetermined detection method (ultrasonic wave, light, etc.).
  • the blood filter 20 filters blood or removes bubbles in the blood.
  • the flow sensor 21 includes an ultrasonic transmitter / receiver, and measures the flow rate of blood in the circulation circuit.
  • the branch line 19 switches the flow path of the circulation circuit.
  • a circulation circuit that passes through the body of the subject 30 is constructed to circulate the blood outside the subject 30.
  • the circulation circuit in other words, the subject 30
  • the circulation circuit passes only outside the body of the subject 30 by blocking the path of the circulation circuit into the body of the subject 30 by the branch line 19.
  • a circulation circuit that does not pass through the body of the body is constructed, and the priming liquid is circulated by filling the circulation circuit with the priming liquid (without passing through the body of the subject).
  • one or a plurality of bubble discharge ports for discharging bubbles are provided on the circulation circuit.
  • the priming liquid By circulating the priming liquid over a plurality of circumferences in the circulation circuit, the bubbles in the circulation circuit are formed. It is discharged from the bubble discharge port.
  • the controller 11 controls the overall operation of the extracorporeal circulation device 10. For example, the controller 11 controls the drive motor 12 to drive the centrifugal pump 13, controls the bubble sensor 18 to acquire a bubble detection result (sensor value), and controls the flow sensor 21 to control the flow rate. Get the value. In addition, the controller 11 also controls the priming operation.
  • the controller 11 controls the execution of the priming operation.
  • a circulation circuit that does not pass through the body of the subject 30 is constructed by the branch line 19 as shown in FIG. 1B.
  • the priming liquid supply source 22 is connected to the branch line 19, and the priming liquid is supplied from the priming liquid supply source 22 into the circulation circuit.
  • the circulation circuit is filled with the priming liquid.
  • the centrifugal pump 13 is driven under the control of the controller 11, and the priming liquid circulates in the circulation circuit over a plurality of turns. Bubbles in the circulation circuit are discharged from the bubble discharge port or the like in this circulation. At this time, bubbles in the circulation circuit are detected by the bubble sensor 18, and the controller 11 monitors the state of the bubbles included in the circulation circuit based on the detection result of the bubble sensor 18.
  • the controller 11 terminates the priming operation when it detects that air bubbles disappear from the circulation circuit in accordance with a predetermined standard (details of the predetermined standard will be described later).
  • the controller 11 notifies the user that the priming operation has ended using a display (not shown), a speaker (not shown), or the like.
  • the user who has received the notification of the end of the priming operation switches the branch line 19 and constructs a circulation circuit that passes through the body of the subject 30 as shown in FIG. 1A. Thereby, the blood of the subject 30 is circulated extracorporeally.
  • blood that has been removed from the catheter (venous side) 16 enters the artificial lung 14 via the centrifugal pump 13.
  • gas exchange that is, processing such as oxygen addition and carbon dioxide removal is performed.
  • the filtered blood is fed from the catheter (arterial side) 17 into the body of the subject 30 through the blood filter 20 and the like. This process from blood removal to blood delivery is repeated, and the blood of the subject 30 is circulated extracorporeally.
  • the controller 11 includes a communication unit 41, a display unit 42, an operation unit 43, a storage unit 44, a control unit 45, and a timer unit 46 as its functional configuration.
  • the display unit 42 is realized by a display such as a monitor, for example, and displays various types of information for the user.
  • the operation unit 43 is realized by various buttons, for example, and inputs an instruction from the user. Note that a part or all of the display unit 42 and the operation unit 43 may be realized as a touch panel, for example.
  • the storage unit 44 is realized by, for example, a hard disk and stores various information.
  • the communication unit 41 is realized by, for example, a network card or the like, and exchanges various data with an external information processing apparatus.
  • the timer unit 46 measures various times.
  • the controller 45 is realized by, for example, a CPU (Central Processing Unit), a ROM (Read Only Memory), a RAM (Random Access Memory), and the like, and comprehensively controls the processing in the controller 11.
  • a CPU Central Processing Unit
  • ROM Read Only Memory
  • RAM Random Access Memory
  • control unit 45 may include a priming control unit 51, a sensor value acquisition unit 52, an end determination unit 53, and a notification unit 55.
  • Each unit constituting the control unit 45 can be realized, for example, when the CPU reads and executes a program stored in the ROM, the storage unit 44, or the like.
  • the priming control unit 51 controls execution of a priming operation for circulating the priming liquid in the circulation circuit.
  • the sensor value acquisition unit 52 acquires various sensor values from the bubble sensor 18 and the flow rate sensor 21.
  • the end determination unit 53 determines the end of the priming operation.
  • the end determination unit 53 uses the various sensor values acquired by the sensor value acquisition unit 52, the time measurement result of the timer unit 46, and various setting information stored in the storage unit 44 and the like to calculate the end determination of the priming operation.
  • the calculating part 54 which performs can be provided.
  • the notification unit 55 When the end of the priming operation is determined, the notification unit 55 notifies the user that the priming operation has ended using the display unit 42, a speaker (not shown), or the like.
  • the above is an explanation of an example of a functional configuration of the controller 11.
  • the configuration shown in FIG. 2 is merely an example, and a new configuration may be added, and unnecessary configurations may be omitted as appropriate.
  • the storage unit 44 (hard disk or the like) is not necessarily provided and may be omitted.
  • the extracorporeal circulation device 10 drives the centrifugal pump 13 to start circulation of the priming liquid in the circulation circuit.
  • the end determination unit 53 determines whether or not bubbles are detected based on the detection result from the bubble sensor 18 (S102). If a bubble is detected as a result of the determination (NO in S102), the process of S102 is repeated until no bubble is detected (YES in S102).
  • the timer unit 46 starts measuring the time without bubbles. Then, in the end determination unit 53, it is determined whether or not the counted bubble-free time has exceeded a predetermined time threshold (S104). If the time threshold is not exceeded as a result of the determination (NO in S104), the extracorporeal circulation device 10 continuously monitors the detection result from the bubble sensor 18 in the end determination unit 53 (S105).
  • the extracorporeal circulation device 10 resets the no-bubble time being measured by the timer unit 46 (S106), and then returns to the process of S102 again.
  • the end determination unit 53 performs the determination in S104 again. If the time without bubbles exceeds the time threshold (YES in S104), in the extracorporeal circulation device 10, the end determination unit 53 determines the end of the priming operation, and the notification unit 55 notifies the user accordingly. (S107). Thereafter, the priming process is terminated.
  • This time threshold value is a threshold value that serves as a reference for determining whether or not bubbles are eliminated from the circulation circuit (that is, whether or not the time change of the bubble amount is zero).
  • the time threshold value is obtained by, for example, calculation processing by the calculation unit 54.
  • the extracorporeal circulation device 10 is configured to allow the controller 11 to set a value (number of laps), a tube cross-sectional area, and a flow path length corresponding to the above n via the operation unit 43 before starting the priming operation, for example. Can be done.
  • n that is, 2 laps
  • volume for one round of the flow path of the circulation circuit is obtained by the following equation.
  • Volume for one circuit in the circulation circuit tube cross-sectional area x channel length
  • n may be updated and set as appropriate based on rules of thumb.
  • the controller 11 uses, for example, the storage unit 44 and the like to calculate the rotational driving force at various stages and the corresponding flow velocity. Hold in advance.
  • the present embodiment it is possible to determine the end of the priming operation based on the bubbles in the circulation circuit and notify the user of that fact, so the convenience for the user is improved.
  • the case where the priming operation is performed at a constant speed has been described.
  • the priming operation is performed using a method (rhythm formula) for changing the flow rate of the priming liquid.
  • rhythm-type priming operation by changing the flow velocity, the bubbles staying in the uneven parts in the circulation circuit are changed from the staying state to the circulation state (the state circulating in the circulation circuit). The air can be vented efficiently.
  • the time threshold described above may be maintained constant, but may be updated in accordance with the timing at which the flow rate of the priming liquid changes (rhythm change timing). For example, when the flow rate of the priming solution is increased, the time threshold value is shortened accordingly. For example, when the flow rate of the priming solution is decreased, the time threshold value is increased accordingly.
  • the update of the time threshold value may be performed in accordance with, for example, the rhythm change timing specified based on the sensor value of the flow sensor 21, the internal value of the controller 11, or the like.
  • Such a time threshold is updated if the time threshold is constant when performing a rhythmic priming operation, the priming liquid is circulated less than the originally intended lap or more than the originally intended lap. This is because there is a possibility that the determination of the end of the priming operation may be hindered.
  • FIG. 4 is a diagram showing an example of transition of the accumulated volume of bubbles during the priming operation.
  • the vertical axis represents the cumulative volume of bubbles detected by the bubble sensor 18, and the horizontal axis represents the cumulative amount of priming liquid from the start of the priming operation (the cumulative amount that has passed through the flow sensor 21).
  • the cumulative amount of priming liquid from the start of the priming operation and the elapsed time have a proportional relationship.
  • the bubble volume is monitored, and the bubble volume increase rate ⁇ 1 (first time) per predetermined cumulative amount of priming liquid (per monitoring unit time: within a predetermined time period (monitoring unit time) from the present time). ) Is divided by the bubble volume increase rate ⁇ 2 (second increase rate) from the start of priming to the present time, it is possible to determine whether or not there are no more bubbles from the circulation circuit. .
  • the degree of convergence is obtained by the following equation, it is determined whether or not the degree of convergence is below the reference value, and if it is below the reference value, the end of the priming operation can be determined.
  • the flow path length of the circulation circuit (flow path length of the circulation circuit shown in FIG. 1B), the tube cross-sectional area, and the number of turns are set in advance. .
  • the extracorporeal circulation device 10 When the extracorporeal circulation device 10 starts the priming operation (S201), the extracorporeal circulation device 10 drives the centrifugal pump 13 to start circulation of the priming liquid in the circulation circuit. Then, the end determination unit 53 acquires the bubble detection result by the bubble sensor 18 at regular intervals (for example, 2 msec), and stores it in the storage unit 44 or the like in association with the time information (S202). The process of S202 is continuously performed until the end of the priming operation is determined.
  • regular intervals for example, 2 msec
  • the calculation unit 54 determines the volume of bubbles per monitoring unit time (within the past monitoring unit time from the present time). Is calculated (S204), and the bubble volume increase rate ⁇ 2 from the start of the priming operation to the present time is calculated (S205). Then, the end determination unit 53 determines whether or not the convergence degree c obtained from the increase rate ⁇ 1 / increase rate ⁇ 2 is equal to or less than the reference value (S206). If not below the reference value (NO in S206), the extracorporeal circulation device 10 returns to the process of S203 again.
  • the end determination unit 53 determines the end of the priming operation and notifies the user of that (S207). This process is terminated.
  • the extracorporeal circulation device 10 causes the user to set the value (number of laps) corresponding to the above n, the tube cross-sectional area, and the flow path length in the controller 11 via the operation unit 43 before starting the priming operation. Can be configured.
  • the monitoring unit time is obtained by, for example, calculation processing by the calculation unit 54.
  • the end of the priming operation is determined and notified to the user based on the accumulated value of the volume of the bubbles detected from the time when the priming operation is started. Also in this case, the same effect as the first embodiment can be obtained.
  • the monitoring unit time is updated and set in accordance with the rhythm change timing. For example, when the flow rate of the priming solution is increased, the monitoring unit time is shortened accordingly. For example, when the flow rate of the priming solution is decreased, the monitoring unit time is increased accordingly.
  • a predicted time calculation unit that calculates the predicted time until the end of the priming operation (not (Not shown) may be further provided to notify the user of the predicted time obtained by the predicted time calculation unit.
  • the bubble reduction degree with the passage of time may be obtained based on the bubble detection result, and the predicted time may be appropriately updated (for example, updated at predetermined time intervals) accordingly and displayed.

Abstract

The present invention is an extracorporeal circulation device which extracorporeally circulates blood of a subject using an extracorporeal circuit, and is provided with: priming control means which, in a state in which a path of the extracorporeal circuit to within the body of the subject is blocked, performs a priming operation for circulating priming fluid within the extracorporeal circuit in order to remove bubbles within the extracorporeal circuit; detection means which detects bubbles within the extracorporeal circuit during the priming operation; assessment means which assesses completion of the priming operation on the basis of variation with time of the detection results of the bubbles by way of the detection means; and notification means which, if completion of the priming operation has been assessed by the assessment means, notifies the user of the completion.

Description

体外循環装置及びプライミング方法Extracorporeal circulation device and priming method
　本発明は、体外循環装置及びプライミング方法に関する。 The present invention relates to an extracorporeal circulation device and a priming method.
　従来、体外循環装置として、例えば、心肺補助に使用される心肺補助装置が知られている。このような装置は、人工肺、遠心式人工心臓（遠心ポンプ）、コントローラ、酸素供給源（酸素ボンベ）等から構成される血液体外循環回路を備えている。 Conventionally, as an extracorporeal circulation device, for example, a cardiopulmonary assist device used for cardiopulmonary assist is known. Such an apparatus includes an extracorporeal blood circulation circuit including an artificial lung, a centrifugal artificial heart (centrifugal pump), a controller, an oxygen supply source (oxygen cylinder), and the like.
　一般に、体外循環装置の使用に際しては、プライミング液（例えば、生理食塩水）を用いたプライミング動作が行なわれる。プライミング動作とは、プライミング液で血液体外循環回路を十分に満たした状態で、通常の動作中の回転数よりも速い回転数で回路内のプライミング液を循環させ、回路内から空気抜きを行なう動作をいう。プライミング動作を行なうことにより、血液体外循環回路内から空気を除去することができる（例えば、特許文献１参照）。 Generally, when using an extracorporeal circulation device, a priming operation using a priming solution (for example, physiological saline) is performed. The priming operation is an operation that bleeds air from the circuit by circulating the priming solution in the circuit at a faster rotational speed than the normal operating speed with the priming fluid sufficiently filling the extracorporeal circuit. Say. By performing the priming operation, air can be removed from the blood extracorporeal circuit (see, for example, Patent Document 1).
特開２００７－２３６５６４号公報JP 2007-236564 A
　しかしながら、従来のプライミング動作では、血液体外循環回路内から空気が十分に除去できたか否かの判定をユーザ自身が行なっていた。具体的には、目視により、或いは、プライミング動作開始時からの経過時間等を目安として、プライミング動作の終了の判定が行なわれていた。 However, in the conventional priming operation, the user himself / herself determines whether or not air has been sufficiently removed from the blood extracorporeal circuit. Specifically, the end of the priming operation is determined visually or based on the elapsed time from the start of the priming operation.
　つまり、プライミング動作によって十分に空気が抜けているであろう、といった曖昧な判定基準によってプライミング動作の終了判定が行なわれていた。このため、不必要に時間がかかったり、あるいは、不完全な状態（空気か抜け切れていない状態）でプライミング動作を終了させてしまうといった事態が懸念されていた。 That is, the end determination of the priming operation was performed based on an ambiguous determination criterion that air would be sufficiently removed by the priming operation. For this reason, there has been a concern that the priming operation may be terminated in an unnecessarily long state or in an incomplete state (a state in which air is not completely removed).
　本発明は、上記課題に鑑みてなされたものであり、プライミング動作の終了をより正確に判定することを目的とする。 The present invention has been made in view of the above problems, and an object thereof is to more accurately determine the end of a priming operation.
　上記課題を解決するため、本発明の一態様は、被検者の血液を循環回路を用いて体外で循環させる体外循環装置であって、前記被検者の体内への前記循環回路の経路を遮断した状態で前記循環回路にプライミング液を循環させて前記循環回路内の気泡を除去するためのプライミング動作の実行を制御するプライミング制御手段と、前記プライミング動作中に前記循環回路内の気泡を検出する検出手段と、前記検出手段による気泡の検出結果の時間変化に基づいて前記プライミング動作の終了を判定する判定手段と、前記判定手段により前記プライミング動作が終了したと判定された場合に、その旨をユーザに通知する通知手段とを具備する。 In order to solve the above-described problem, an aspect of the present invention is an extracorporeal circulation device that circulates the blood of a subject outside the body using a circulation circuit, the route of the circulation circuit into the body of the subject. Priming control means for controlling the execution of a priming operation for circulating the priming liquid in the circulation circuit in the shut-off state to remove the bubbles in the circulation circuit, and detecting the bubbles in the circulation circuit during the priming operation Detecting means for determining, the determining means for determining the end of the priming operation based on the time change of the bubble detection result by the detecting means, and when the determining means determines that the priming operation has ended, to that effect And notifying means for notifying the user.
　本発明によれば、プライミング動作の終了を、より正確に判定できるようになる。 According to the present invention, the end of the priming operation can be determined more accurately.
　本発明のその他の特徴及び利点は、添付図面を参照とした以下の説明により明らかになるであろう。なお、添付図面においては、同じ若しくは同様の構成には、同じ参照番号を付す。 Other features and advantages of the present invention will become apparent from the following description with reference to the accompanying drawings. In the accompanying drawings, the same or similar components are denoted by the same reference numerals.
　添付図面は明細書に含まれ、その一部を構成し、本発明の実施の形態を示し、その記述と共に本発明の原理を説明するために用いられる。
本発明の第１の実施形態に係る体外循環装置１０の全体構成の一例を示す図である。 本発明の第１の実施形態に係る体外循環装置１０の全体構成の一例を示す図である。 図１Ａ、１Ｂに示すコントローラ１１の機能的な構成の一例を示す図である。 図１Ａ、１Ｂに示す体外循環装置１０のプライミング処理の流れの一例を示すフローチャートである。 プライミング動作中の累積気泡体積の推移の一例を示す図である。 第２の実施形態に係る体外循環装置１０のプライミング処理の流れの一例を示すフローチャートである。 The accompanying drawings are included in the specification, constitute a part thereof, show an embodiment of the present invention, and are used to explain the principle of the present invention together with the description.
It is a figure showing an example of the whole composition of extracorporeal circulation device 10 concerning a 1st embodiment of the present invention. It is a figure showing an example of the whole composition of extracorporeal circulation device 10 concerning a 1st embodiment of the present invention. It is a figure which shows an example of a functional structure of the controller 11 shown to FIG. 1A and 1B. It is a flowchart which shows an example of the flow of the priming process of the extracorporeal circulation apparatus 10 shown to FIG. 1A and 1B. It is a figure which shows an example of transition of the accumulation bubble volume in priming operation | movement. It is a flowchart which shows an example of the flow of the priming process of the extracorporeal circulation apparatus 10 which concerns on 2nd Embodiment.
　以下、本発明の各実施形態について添付図面を参照して詳細に説明する。 Hereinafter, embodiments of the present invention will be described in detail with reference to the accompanying drawings.
　［第１の実施形態］
　＜１．体外循環装置の全体構成＞
　図１Ａは、本発明の第１の実施形態に係る体外循環装置１０の全体構成の一例を示す図である。 [First Embodiment]
<1. Overall configuration of extracorporeal circulation device>
FIG. 1A is a diagram illustrating an example of the overall configuration of the extracorporeal circulation device 10 according to the first embodiment of the present invention.
　体外循環装置１０は、ＰＣＰＳ（percutaneouscardiopulmonary support）と呼ばれる手技を行なうのに用いる心肺補助動作（体外循環、補助循環）を行なう。体外循環装置１０は、図中矢印で示す血液体外循環回路（以下、循環回路と呼ぶ）を有している。体外循環装置１０では、プライミング動作を行なった後、この循環回路を用いて被検者３０の血液を体外循環させる。 The extracorporeal circulation device 10 performs a cardiopulmonary assist operation (extracorporeal circulation, auxiliary circulation) used to perform a procedure called PCPS (percutaneous cardiopulmonary support). The extracorporeal circulation device 10 has a blood extracorporeal circuit (hereinafter referred to as a circulation circuit) indicated by an arrow in the figure. In the extracorporeal circulation device 10, after performing the priming operation, the blood of the subject 30 is circulated extracorporeally using this circulation circuit.
　ここで、プライミング動作とは、プライミング液（例えば、生理食塩水）で循環回路を十分に満たした状態で、当該回路内でプライミング液を循環させ、当該回路内の気泡を除去する動作をいう。 Here, the priming operation refers to an operation of removing the bubbles in the circuit by circulating the priming solution in the circuit in a state where the circulation circuit is sufficiently filled with the priming solution (for example, physiological saline).
　体外循環装置１０には、コントローラ１１と、ドライブモータ１２と、遠心ポンプ１３と、人工肺１４と、酸素供給源１５と、カテーテル（静脈側）１６と、カテーテル（動脈側）１７と、気泡センサ１８と、分岐ライン１９と、血液フィルタ２０と、流量センサ２１とが具備されうる。なお、これら各構成の間は、柔軟性を有するチューブ等によって接続されており、当該チューブの内腔が血液の流路を構成している。 The extracorporeal circulation device 10 includes a controller 11, a drive motor 12, a centrifugal pump 13, an artificial lung 14, an oxygen supply source 15, a catheter (venous side) 16, a catheter (arterial side) 17, and a bubble sensor. 18, a branch line 19, a blood filter 20, and a flow sensor 21 may be provided. These components are connected by a flexible tube or the like, and the lumen of the tube forms a blood flow path.
　カテーテル（動脈側）１７は、被検者３０の体内に向けて送血し、カテーテル（静脈側）１６は、被検者３０の体内から脱血を行なう。 The catheter (arterial side) 17 pumps blood toward the body of the subject 30, and the catheter (venous side) 16 performs blood removal from the body of the subject 30.
　遠心ポンプ１３は、遠心式人工心臓とも呼ばれ、内部に設けられた回転体を駆動させて血液に圧力を与え、循環回路内で血液を循環させる。ドライブモータ１２は、遠心ポンプ１３の回転体に回転駆動力を与える。 The centrifugal pump 13 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 12 applies a rotational driving force to the rotating body of the centrifugal pump 13.
　人工肺１４は、血液の循環と血液のガス交換（酸素付加、二酸化炭素除去等）とを行なう。酸素供給源１５は、例えば、酸素ボンベ等で実現され、血液に付加する酸素を供給する。酸素供給源１５から供給される酸素は、人工肺１４によるガス交換時に使用される。 The artificial lung 14 performs blood circulation and blood gas exchange (oxygenation, carbon dioxide removal, etc.). The oxygen supply source 15 is realized by, for example, an oxygen cylinder and supplies oxygen to be added to blood. The oxygen supplied from the oxygen supply source 15 is used at the time of gas exchange by the artificial lung 14.
　気泡センサ１８は、プライミング動作時に循環回路内を流れる気泡を所定の検出方法（超音波、光等）により検出する。血液フィルタ２０は、血液をろ過したり、血液中の気泡を除去したりする。流量センサ２１は、例えば、超音波の送受信器を内蔵して構成され、循環回路内の血液の流量を計測する。 The bubble sensor 18 detects bubbles flowing in the circulation circuit during the priming operation by a predetermined detection method (ultrasonic wave, light, etc.). The blood filter 20 filters blood or removes bubbles in the blood. For example, the flow sensor 21 includes an ultrasonic transmitter / receiver, and measures the flow rate of blood in the circulation circuit.
　分岐ライン１９は、循環回路の流路を切り替える。具体的には、被検者３０の血液を体外循環させる場合には、図１Ａに示すように、被検者３０の体内を通る循環回路を構築し、被検者３０の体外で血液を循環させる。プライミング動作時には、図１Ｂに示すように、分岐ライン１９によって被検者３０の体内への循環回路の経路を遮断して被検者３０の体外のみを通る循環回路（言い換えれば、被検者３０の体内を通らない循環回路）を構築し、プライミング液で循環回路内を満たして（被検者の体内を通らずに）プライミング液を循環させる。循環回路上には、気泡を排出するための１又は複数の気泡排出ポート（不図示）が設けられており、循環回路内でプライミング液を複数周にわたって循環させることにより、循環回路内の気泡が当該気泡排出ポートから排出されることになる。 The branch line 19 switches the flow path of the circulation circuit. Specifically, when the blood of the subject 30 is circulated extracorporeally, as shown in FIG. 1A, a circulation circuit that passes through the body of the subject 30 is constructed to circulate the blood outside the subject 30. Let At the time of the priming operation, as shown in FIG. 1B, the circulation circuit (in other words, the subject 30) passes only outside the body of the subject 30 by blocking the path of the circulation circuit into the body of the subject 30 by the branch line 19. A circulation circuit that does not pass through the body of the body is constructed, and the priming liquid is circulated by filling the circulation circuit with the priming liquid (without passing through the body of the subject). On the circulation circuit, one or a plurality of bubble discharge ports (not shown) for discharging bubbles are provided. By circulating the priming liquid over a plurality of circumferences in the circulation circuit, the bubbles in the circulation circuit are formed. It is discharged from the bubble discharge port.
　コントローラ１１は、体外循環装置１０における動作を統括制御する。コントローラ１１は、例えば、ドライブモータ１２を制御して遠心ポンプ１３を駆動させたり、気泡センサ１８を制御して気泡検出結果（センサ値）を取得したり、また、流量センサ２１を制御して流量値を取得したりする。その他、コントローラ１１においては、プライミング動作の制御等も行なう。 The controller 11 controls the overall operation of the extracorporeal circulation device 10. For example, the controller 11 controls the drive motor 12 to drive the centrifugal pump 13, controls the bubble sensor 18 to acquire a bubble detection result (sensor value), and controls the flow sensor 21 to control the flow rate. Get the value. In addition, the controller 11 also controls the priming operation.
　ここで、図１Ａ及び図１Ｂに示す体外循環装置１０を用いて被検者３０の血液を体外循環させる際の処理の流れについて簡単に説明する。 Here, the flow of processing when extracorporeally circulating the blood of the subject 30 using the extracorporeal circulation device 10 shown in FIGS. 1A and 1B will be briefly described.
　この処理の開始に際して、コントローラ１１は、プライミング動作の実行を制御する。プライミング動作時には、図１Ｂに示すように、分岐ライン１９によって被検者３０の体内を通らない循環回路が構築される。また、このとき、プライミング液供給源２２が分岐ライン１９に接続され、当該プライミング液供給源２２から循環回路内にプライミング液が供給される。これにより、循環回路内は、プライミング液で満たされることになる。 At the start of this process, the controller 11 controls the execution of the priming operation. During the priming operation, a circulation circuit that does not pass through the body of the subject 30 is constructed by the branch line 19 as shown in FIG. 1B. At this time, the priming liquid supply source 22 is connected to the branch line 19, and the priming liquid is supplied from the priming liquid supply source 22 into the circulation circuit. As a result, the circulation circuit is filled with the priming liquid.
　そして、コントローラ１１による制御下で遠心ポンプ１３が駆動され、プライミング液が循環回路内を複数周にわたって循環する。循環回路内の気泡は、この循環において気泡排出ポート等から排出される。このとき、気泡センサ１８によって当該循環回路内の気泡が検出され、コントローラ１１は、当該気泡センサ１８の検出結果に基づいて循環回路内に含まれる気泡の状態を監視する。 Then, the centrifugal pump 13 is driven under the control of the controller 11, and the priming liquid circulates in the circulation circuit over a plurality of turns. Bubbles in the circulation circuit are discharged from the bubble discharge port or the like in this circulation. At this time, bubbles in the circulation circuit are detected by the bubble sensor 18, and the controller 11 monitors the state of the bubbles included in the circulation circuit based on the detection result of the bubble sensor 18.
　ここで、コントローラ１１は、所定の基準（所定の基準の詳細については後述する）に従って循環回路内から気泡がなくなったことを検出すると、プライミング動作を終了させる。この終了に際して、コントローラ１１は、表示器（不図示）やスピーカ（不図示）等を用いて、ユーザにプライミング動作が終了したことを通知する。プライミング動作の終了の通知を受けたユーザは、分岐ライン１９を切り替え、図１Ａに示すように、被検者３０の体内を通る循環回路を構築する。これにより、被検者３０の血液が体外循環される。 Here, the controller 11 terminates the priming operation when it detects that air bubbles disappear from the circulation circuit in accordance with a predetermined standard (details of the predetermined standard will be described later). At the end of the operation, the controller 11 notifies the user that the priming operation has ended using a display (not shown), a speaker (not shown), or the like. The user who has received the notification of the end of the priming operation switches the branch line 19 and constructs a circulation circuit that passes through the body of the subject 30 as shown in FIG. 1A. Thereby, the blood of the subject 30 is circulated extracorporeally.
　体外循環が始まると、カテーテル（静脈側）１６から脱血されてくる血液が、遠心ポンプ１３を経て人工肺１４に入る。人工肺１４では、上述した通り、ガス交換、すなわち、酸素付加や二酸化炭素除去等の処理が行なわれる。その後、血液フィルタ２０等を経て、ろ過された血液が、カテーテル（動脈側）１７から被検者３０の体内に送血される。この脱血から送血までの処理が繰り返し行なわれ、被検者３０の血液が体外循環される。 When extracorporeal circulation begins, blood that has been removed from the catheter (venous side) 16 enters the artificial lung 14 via the centrifugal pump 13. In the artificial lung 14, as described above, gas exchange, that is, processing such as oxygen addition and carbon dioxide removal is performed. Thereafter, the filtered blood is fed from the catheter (arterial side) 17 into the body of the subject 30 through the blood filter 20 and the like. This process from blood removal to blood delivery is repeated, and the blood of the subject 30 is circulated extracorporeally.
　以上が、本実施形態に係わる体外循環装置１０の全体構成及び体外循環の処理の流れの一例についての説明である。なお、図１Ａ及び図１Ｂに示す体外循環装置１０の構成は、あくまでも一例であり、その構成は適宜変更すれば良い。例えば、リザーバ（血液を貯血）が設けられていても良い。 The above is an explanation of the overall configuration of the extracorporeal circulation apparatus 10 according to the present embodiment and an example of the flow of extracorporeal circulation processing. Note that the configuration of the extracorporeal circulation device 10 shown in FIGS. 1A and 1B is merely an example, and the configuration may be changed as appropriate. For example, a reservoir (which stores blood) may be provided.
　＜２．コントローラの機能構成＞
　次に、図２を用いて、図１Ａ、１Ｂに示すコントローラ１１の機能構成の一例について説明する。 <2. Functional configuration of controller>
Next, an example of a functional configuration of the controller 11 illustrated in FIGS. 1A and 1B will be described with reference to FIG.
　コントローラ１１は、その機能構成として、通信部４１と、表示部４２と、操作部４３と、記憶部４４と、制御部４５と、タイマー部４６とを備える。 The controller 11 includes a communication unit 41, a display unit 42, an operation unit 43, a storage unit 44, a control unit 45, and a timer unit 46 as its functional configuration.
　表示部４２は、例えば、モニタ等の表示器で実現され、各種情報をユーザに向けて表示する。操作部４３は、例えば、各種ボタン等で実現され、ユーザからの指示を入力する。なお、表示部４２及び操作部４３の一部又は全部は、例えば、タッチパネルとして実現されても良い。 The display unit 42 is realized by a display such as a monitor, for example, and displays various types of information for the user. The operation unit 43 is realized by various buttons, for example, and inputs an instruction from the user. Note that a part or all of the display unit 42 and the operation unit 43 may be realized as a touch panel, for example.
　記憶部４４は、例えば、ハードディスク等で実現され、各種情報を格納する。通信部４１は、例えば、ネットワークカード等で実現され、外部の情報処理装置との間で各種データの授受を行なう。タイマー部４６は、各種時間の計時を行なう。 The storage unit 44 is realized by, for example, a hard disk and stores various information. The communication unit 41 is realized by, for example, a network card or the like, and exchanges various data with an external information processing apparatus. The timer unit 46 measures various times.
　制御部４５、例えば、ＣＰＵ（Central Processing Unit）、ＲＯＭ（Read Only Memory）及びＲＡＭ（Random Access Memory）等で実現され、コントローラ１１における処理を統括制御する。 The controller 45 is realized by, for example, a CPU (Central Processing Unit), a ROM (Read Only Memory), a RAM (Random Access Memory), and the like, and comprehensively controls the processing in the controller 11.
　ここで、制御部４５は、プライミング制御部５１と、センサ値取得部５２と、終了判定部５３と、通知部５５とを備えうる。制御部４５を構成する各部は、例えば、ＣＰＵがＲＯＭや記憶部４４等に記憶されたプログラムを読み出し実行することにより実現されうる。 Here, the control unit 45 may include a priming control unit 51, a sensor value acquisition unit 52, an end determination unit 53, and a notification unit 55. Each unit constituting the control unit 45 can be realized, for example, when the CPU reads and executes a program stored in the ROM, the storage unit 44, or the like.
　プライミング制御部５１は、プライミング液を循環回路で循環させるプライミング動作の実行を制御する。センサ値取得部５２は、気泡センサ１８や流量センサ２１等から各種センサ値を取得する。 The priming control unit 51 controls execution of a priming operation for circulating the priming liquid in the circulation circuit. The sensor value acquisition unit 52 acquires various sensor values from the bubble sensor 18 and the flow rate sensor 21.
　終了判定部５３は、プライミング動作の終了判定を行なう。終了判定部５３は、センサ値取得部５２により取得された各種センサ値、タイマー部４６の計時結果、及び記憶部４４等に記憶された各種設定情報を用いて、プライミング動作の終了判定の演算処理を行なう演算部５４を備えうる。 The end determination unit 53 determines the end of the priming operation. The end determination unit 53 uses the various sensor values acquired by the sensor value acquisition unit 52, the time measurement result of the timer unit 46, and various setting information stored in the storage unit 44 and the like to calculate the end determination of the priming operation. The calculating part 54 which performs can be provided.
　通知部５５は、プライミング動作の終了判定が行なわれた場合に、表示部４２やスピーカ（不図示）等を用いて、ユーザにプライミング動作が終了したことを通知する。 When the end of the priming operation is determined, the notification unit 55 notifies the user that the priming operation has ended using the display unit 42, a speaker (not shown), or the like.
　以上が、コントローラ１１についての機能的な構成の一例についての説明である。なお、図２に示す構成はあくまでも一例であり、新たな構成を追加しても良いし、また、不要な構成は適宜省略しても良い。例えば、記憶部４４（ハードディスク等）は、必ずしも設けられる必要なく、省略しても良い。 The above is an explanation of an example of a functional configuration of the controller 11. Note that the configuration shown in FIG. 2 is merely an example, and a new configuration may be added, and unnecessary configurations may be omitted as appropriate. For example, the storage unit 44 (hard disk or the like) is not necessarily provided and may be omitted.
　＜３．プライミング処理の流れ＞
　次に、図３を用いて、図１Ａに示す体外循環装置１０においてプライミング動作を行なう際の処理の流れの一例について説明する。ここでは、プライミング液を一定の流速で循環させてプライミング動作を行なう場合について説明する。なお、詳細については後述するが、コントローラ１１においては、循環回路の流路長（図１Ｂに示す循環回路の流路長）、チューブ断面積、周回数が予め設定されているものとする。 <3. Priming process flow>
Next, an example of the flow of processing when performing the priming operation in the extracorporeal circulation device 10 shown in FIG. 1A will be described with reference to FIG. Here, a case where the priming operation is performed by circulating the priming liquid at a constant flow rate will be described. Although details will be described later, in the controller 11, the flow path length of the circulation circuit (flow path length of the circulation circuit shown in FIG. 1B), the tube cross-sectional area, and the number of turns are set in advance.
　体外循環装置１０は、プライミング動作を開始すると（Ｓ１０１）、遠心ポンプ１３を駆動し、循環回路内においてプライミング液の循環を開始する。 When the extracorporeal circulation device 10 starts the priming operation (S101), the extracorporeal circulation device 10 drives the centrifugal pump 13 to start circulation of the priming liquid in the circulation circuit.
　プライミング液の循環を開始すると、体外循環装置１０では、終了判定部５３が、気泡センサ１８からの検出結果に基づいて気泡が検出されたか否かを判定する（Ｓ１０２）。判定の結果、気泡が検出されれば（Ｓ１０２でＮＯ）、気泡が検出されなくなるまで（Ｓ１０２でＹＥＳ）、Ｓ１０２の処理を繰り返し行なう。 When the circulation of the priming liquid is started, in the extracorporeal circulation device 10, the end determination unit 53 determines whether or not bubbles are detected based on the detection result from the bubble sensor 18 (S102). If a bubble is detected as a result of the determination (NO in S102), the process of S102 is repeated until no bubble is detected (YES in S102).
　Ｓ１０２の処理の結果、気泡が検出されなければ（Ｓ１０２でＹＥＳ）、体外循環装置１０では、タイマー部４６が、気泡なし時間の計時を開始する。そして、終了判定部５３において、当該計時された気泡なし時間が、所定の時間閾値を越えたか否かを判定する（Ｓ１０４）。判定の結果、時間閾値を越えていなければ（Ｓ１０４でＮＯ）、体外循環装置１０は、終了判定部５３において、気泡センサ１８からの検出結果の監視を継続して行なう（Ｓ１０５）。 If no bubbles are detected as a result of the processing in S102 (YES in S102), in the extracorporeal circulation device 10, the timer unit 46 starts measuring the time without bubbles. Then, in the end determination unit 53, it is determined whether or not the counted bubble-free time has exceeded a predetermined time threshold (S104). If the time threshold is not exceeded as a result of the determination (NO in S104), the extracorporeal circulation device 10 continuously monitors the detection result from the bubble sensor 18 in the end determination unit 53 (S105).
　この監視中に、気泡が検出された場合（Ｓ１０５でＮＯ）、体外循環装置１０は、タイマー部４６により計時中の気泡なし時間をリセットした後（Ｓ１０６）、再度、Ｓ１０２の処理に戻る。 If an air bubble is detected during this monitoring (NO in S105), the extracorporeal circulation device 10 resets the no-bubble time being measured by the timer unit 46 (S106), and then returns to the process of S102 again.
　一方、Ｓ１０５の判定の結果、気泡が検出されなければ（Ｓ１０５でＹＥＳ）、体外循環装置１０では、終了判定部５３が、再度、Ｓ１０４の判定を行なう。そして、気泡なし時間が時間閾値を越えていれば（Ｓ１０４でＹＥＳ）、体外循環装置１０では、終了判定部５３が、プライミング動作終了の判定を行ない、通知部５５が、その旨をユーザに通知する（Ｓ１０７）。その後、プライミング処理を終了する。 On the other hand, if no bubble is detected as a result of the determination in S105 (YES in S105), in the extracorporeal circulation device 10, the end determination unit 53 performs the determination in S104 again. If the time without bubbles exceeds the time threshold (YES in S104), in the extracorporeal circulation device 10, the end determination unit 53 determines the end of the priming operation, and the notification unit 55 notifies the user accordingly. (S107). Thereafter, the priming process is terminated.
　ここで、上述した時間閾値について説明する。この時間閾値は、循環回路内から気泡がなくなったか否か（つまり、気泡量の時間変化がゼロか否か）の判定の基準となる閾値である。以下、この値の決め方について説明する。時間閾値は、例えば、演算部５４による演算処理により求められる。 Here, the time threshold described above will be described. This time threshold value is a threshold value that serves as a reference for determining whether or not bubbles are eliminated from the circulation circuit (that is, whether or not the time change of the bubble amount is zero). Hereinafter, how to determine this value will be described. The time threshold value is obtained by, for example, calculation processing by the calculation unit 54.
　例えば、気泡が検出されていない状態でプラミング液が循環回路内をｎ周した場合にプライミング動作が終了したと判定することができる。この場合、プライミング液が循環回路内をｎ周するのに要する時間が時間閾値に相当する。体外循環装置１０は、例えば、プライミング動作の開始前に、ユーザに操作部４３を介して上記ｎに対応する値（周回数）、チューブ断面積、流路長をコントローラ１１に設定させるように構成されうる。 For example, it can be determined that the priming operation has been completed when the plumbing liquid has made n revolutions in the circulation circuit in a state where no bubbles are detected. In this case, the time required for the priming liquid to make n turns in the circulation circuit corresponds to the time threshold value. The extracorporeal circulation device 10 is configured to allow the controller 11 to set a value (number of laps), a tube cross-sectional area, and a flow path length corresponding to the above n via the operation unit 43 before starting the priming operation, for example. Can be done.
　ここで、例えば、ｎとして「２」が入力されたとする（すなわち、２周）。 Here, for example, it is assumed that “2” is input as n (that is, 2 laps).
　この場合、時間閾値は、以下の式で求められる。
　時間閾値　＝　循環回路の流路１周分の体積　×　周回（ｎ＝２）／流速 In this case, the time threshold value is obtained by the following equation.
Time threshold = Volume for one round of the flow path of the circulation circuit x Round (n = 2) / flow velocity
　循環回路の流路１周分の体積は、以下の式で求められる。
　循環回路の流路１周分の体積＝チューブ断面積　×　流路長 The volume for one round of the flow path of the circulation circuit is obtained by the following equation.
Volume for one circuit in the circulation circuit = tube cross-sectional area x channel length
　ｎの値は、経験則等に基づいて適宜更新して設定すれば良い。また、流速は、遠心ポンプ１３の回転体の回転駆動力によって規定されるので、コントローラ１１は、例えば、記憶部４４等を用いて、種々の段階の回転駆動力と、それに対応する流速とを予め保持しておく。 The value of n may be updated and set as appropriate based on rules of thumb. In addition, since the flow rate is defined by the rotational driving force of the rotating body of the centrifugal pump 13, the controller 11 uses, for example, the storage unit 44 and the like to calculate the rotational driving force at various stages and the corresponding flow velocity. Hold in advance.
　以上説明したように本実施形態によれば、循環回路内の気泡に基づいてプライミング動作の終了を判定して、その旨をユーザに通知することができるため、ユーザの利便性が向上する。 As described above, according to the present embodiment, it is possible to determine the end of the priming operation based on the bubbles in the circulation circuit and notify the user of that fact, so the convenience for the user is improved.
　また、実際の循環回路内の気泡の検出結果に基づいてプライミング動作の終了を判定してユーザに通知するため、ユーザの目視等に頼る従来の方式よりも正確にプライミング動作の終了を判定することが可能となる。この結果、プライミング動作に、不必要に時間がかかってしまったり、また、不完全な状態（空気か抜け切れていない状態）でプライミング動作を終了させてしまったりといった事態を回避することが可能となる。 Also, in order to determine the end of the priming operation based on the detection result of the bubbles in the actual circulation circuit and notify the user, it is possible to determine the end of the priming operation more accurately than the conventional method that relies on the user's visual inspection Is possible. As a result, it is possible to avoid the situation where the priming operation takes an unnecessarily long time or the priming operation is terminated in an incomplete state (a state where air is not completely removed). Become.
　なお、上述した図３の説明では、定速（プライミング液の流速が一定）でプライミング動作を行なう場合について説明したが、プライミング液の流速を変化させる方式（リズム式）でプライミング動作を行なう場合においても同様である。リズム式のプライミング動作では、流速を変化させることによって、循環回路内の凹凸部分などに滞留している気泡を滞留状態から循環状態（循環回路内を循環する状態）に遷移させるので、循環回路内からの空気抜きを効率良く行なうことができる。 In the description of FIG. 3 described above, the case where the priming operation is performed at a constant speed (the flow rate of the priming liquid is constant) has been described. However, in the case where the priming operation is performed using a method (rhythm formula) for changing the flow rate of the priming liquid. Is the same. In the rhythm-type priming operation, by changing the flow velocity, the bubbles staying in the uneven parts in the circulation circuit are changed from the staying state to the circulation state (the state circulating in the circulation circuit). The air can be vented efficiently.
　このようなリズム式のプライミング動作の場合、上述した時間閾値は、一定に維持されてもよいが、プライミング液の流速が変わるタイミング（リズム変更タイミング）に合わせて更新されてもよい。例えば、プライミング液の流速が速くなる場合には、それに応じて時間閾値を短くし、また、例えば、プライミング液の流速が遅くなる場合には、それに応じて時間閾値を長くすれば良い。 In the case of such a rhythm-type priming operation, the time threshold described above may be maintained constant, but may be updated in accordance with the timing at which the flow rate of the priming liquid changes (rhythm change timing). For example, when the flow rate of the priming solution is increased, the time threshold value is shortened accordingly. For example, when the flow rate of the priming solution is decreased, the time threshold value is increased accordingly.
　時間閾値の更新は、例えば、流量センサ２１のセンサ値やコントローラ１１の内部値等に基づいてリズム変更タイミングを特定し、それに合わせて行っても良い。 The update of the time threshold value may be performed in accordance with, for example, the rhythm change timing specified based on the sensor value of the flow sensor 21, the internal value of the controller 11, or the like.
　このような時間閾値の更新を行なうのは、リズム式のプライミング動作を行なうときに時間閾値を一定とした場合、本来意図した周回に満たない又は本来意図した周回以上にプライミング液を循環させてしまうこととなり、プライミング動作の終了の判定に支障をきたす可能性があるためである。 Such a time threshold is updated if the time threshold is constant when performing a rhythmic priming operation, the priming liquid is circulated less than the originally intended lap or more than the originally intended lap. This is because there is a possibility that the determination of the end of the priming operation may be hindered.
　［第２の実施形態］
　次に、本発明の第２の実施形態について説明する。本実施形態においては、プライミング動作時に検出された気泡の累積体積に基づいてプライミング動作の終了判定を行なう場合について説明する。なお、第２の実施形態に係る体外循環装置１０の構成は、上記第１の実施形態において説明した図１Ａ、１Ｂと同様であるため、ここでは、その説明については省略し、主に、第１の実施形態との相違点について説明する。 [Second Embodiment]
Next, a second embodiment of the present invention will be described. In the present embodiment, a case will be described in which the end determination of the priming operation is performed based on the accumulated volume of bubbles detected during the priming operation. The configuration of the extracorporeal circulation device 10 according to the second embodiment is the same as that shown in FIGS. 1A and 1B described in the first embodiment. Therefore, the description thereof is omitted here, and mainly the first Differences from the first embodiment will be described.
　図４は、プライミング動作中の気泡の累積体積の推移の一例を示す図である。縦軸は、気泡センサ１８により検出された気泡の累積体積を示し、横軸は、プライミング動作開始時からのプライミング液の累積量（流量センサ２１を通過した累積量）を示す。ここでは、プライミング液を一定の流速で循環させてプライミング動作を行なう場合について説明する。そのため、プライミング動作開始時からのプライミング液の累積量と経過時間とは比例関係を持つ。 FIG. 4 is a diagram showing an example of transition of the accumulated volume of bubbles during the priming operation. The vertical axis represents the cumulative volume of bubbles detected by the bubble sensor 18, and the horizontal axis represents the cumulative amount of priming liquid from the start of the priming operation (the cumulative amount that has passed through the flow sensor 21). Here, a case where the priming operation is performed by circulating the priming liquid at a constant flow rate will be described. Therefore, the cumulative amount of priming liquid from the start of the priming operation and the elapsed time have a proportional relationship.
　一例においては、気泡の累積体積を監視し、プライミング液の所定の累積量当たり（監視単位時間当たり：現時点から過去所定時間内（監視単位時間内））の気泡の体積の増加率Δ１（第１の増加率）を、プライミング開始時から現時点までの気泡の体積の増加率Δ２（第２の増加率）で除算した値に基づいて循環回路から気泡がなくなったか否かの判定を行なうことができる。 In one example, the bubble volume is monitored, and the bubble volume increase rate Δ1 (first time) per predetermined cumulative amount of priming liquid (per monitoring unit time: within a predetermined time period (monitoring unit time) from the present time). ) Is divided by the bubble volume increase rate Δ2 (second increase rate) from the start of priming to the present time, it is possible to determine whether or not there are no more bubbles from the circulation circuit. .
　すなわち、下記式により収束度を求め、当該収束度が基準値以下であるか否かを判定し、基準値以下であれば、プライミング動作終了の判定を行なうことができる。 That is, the degree of convergence is obtained by the following equation, it is determined whether or not the degree of convergence is below the reference value, and if it is below the reference value, the end of the priming operation can be determined.
　収束度＝Δ１／Δ２
　この場合、ｔ１～ｔ５の各期間内においては、収束度が基準値を越えており、循環回路内に気泡が依然として残っていると判定される。ｔ６の期間内において、Δ１６／Δ２６により求められた収束度ｃ６が基準値以下となり、ｔ６の期間終了とともにプライミング動作終了の判定が行なわれる。 Convergence = Δ1 / Δ2
In this case, in each period from t1 to t5, the degree of convergence exceeds the reference value, and it is determined that bubbles still remain in the circulation circuit. In the period of t6, convergence c 6 obtained by Δ1 6 / Δ2 6 becomes equal to or less than the reference value, the determination of the priming operation end is performed with a period the end of t6.
　次に、図５を用いて、本実施形態に係る体外循環装置１０においてプライミング動作を行なう際の処理の流れの一例について説明する。ここでは、プライミング液を一定の流速で循環させてプライミング動作を行なう場合について説明する。なお、第１の実施形態と同様に、コントローラ１１においては、循環回路の流路長（図１Ｂに示す循環回路の流路長）、チューブ断面積、周回数が予め設定されているものとする。 Next, an example of the flow of processing when performing a priming operation in the extracorporeal circulation device 10 according to the present embodiment will be described with reference to FIG. Here, a case where the priming operation is performed by circulating the priming liquid at a constant flow rate will be described. As in the first embodiment, in the controller 11, the flow path length of the circulation circuit (flow path length of the circulation circuit shown in FIG. 1B), the tube cross-sectional area, and the number of turns are set in advance. .
　体外循環装置１０は、プライミング動作を開始すると（Ｓ２０１）、遠心ポンプ１３を駆動し、循環回路内においてプライミング液の循環を開始する。そして、終了判定部５３において、気泡センサ１８による気泡の検出結果を一定間隔毎（例えば、２ｍｓｅｃ）に取得し、それを時間情報と対応付けて記憶部４４等に記憶する（Ｓ２０２）。このＳ２０２の処理は、プライミング動作終了の判定が行なわれるまで継続して行なわれる。 When the extracorporeal circulation device 10 starts the priming operation (S201), the extracorporeal circulation device 10 drives the centrifugal pump 13 to start circulation of the priming liquid in the circulation circuit. Then, the end determination unit 53 acquires the bubble detection result by the bubble sensor 18 at regular intervals (for example, 2 msec), and stores it in the storage unit 44 or the like in association with the time information (S202). The process of S202 is continuously performed until the end of the priming operation is determined.
　ここで、プライミング動作を開始してから監視単位時間が経過すると（Ｓ２０３でＹＥＳ）、体外循環装置１０では、演算部５４が、監視単位時間当たり（現時点から過去監視単位時間内）の気泡の体積の増加率Δ１を算出するとともに（Ｓ２０４）、プライミング動作の開始時から現時点までの気泡の体積の増加率Δ２を算出する（Ｓ２０５）。そして、終了判定部５３が、増加率Δ１／増加率Δ２により得られた収束度ｃが、基準値以下となっているか否かを判定する（Ｓ２０６）。基準値以下となっていなければ（Ｓ２０６でＮＯ）、体外循環装置１０は、再度、Ｓ２０３の処理に戻る。 Here, when the monitoring unit time has elapsed since the start of the priming operation (YES in S203), in the extracorporeal circulation apparatus 10, the calculation unit 54 determines the volume of bubbles per monitoring unit time (within the past monitoring unit time from the present time). Is calculated (S204), and the bubble volume increase rate Δ2 from the start of the priming operation to the present time is calculated (S205). Then, the end determination unit 53 determines whether or not the convergence degree c obtained from the increase rate Δ1 / increase rate Δ2 is equal to or less than the reference value (S206). If not below the reference value (NO in S206), the extracorporeal circulation device 10 returns to the process of S203 again.
　一方、収束度ｃが基準値を越えていれば（Ｓ２０６でＹＥＳ）、体外循環装置１０では、終了判定部５３が、プライミング動作の終了を判定し、その旨をユーザに通知した後（Ｓ２０７）、この処理を終了する。 On the other hand, if the degree of convergence c exceeds the reference value (YES in S206), in the extracorporeal circulation apparatus 10, the end determination unit 53 determines the end of the priming operation and notifies the user of that (S207). This process is terminated.
　ここで、上述した監視単位時間について説明する。この監視単位時間としては、プライミング液が循環回路内をｎ周するのに要する時間が設定されうる。この場合、体外循環装置１０は、プライミング動作の開始前に、ユーザに操作部４３を介して上記ｎに対応する値（周回数）、チューブ断面積、流路長をコントローラ１１に設定させるように構成されうる。 Here, the above-described monitoring unit time will be described. As the monitoring unit time, a time required for the priming liquid to make n revolutions in the circulation circuit can be set. In this case, the extracorporeal circulation device 10 causes the user to set the value (number of laps) corresponding to the above n, the tube cross-sectional area, and the flow path length in the controller 11 via the operation unit 43 before starting the priming operation. Can be configured.
　なお、監視単位時間の求め方は、上述した第１の実施形態で説明した時間閾値と同様であるため、ここでは、その説明については省略する。監視単位時間は、例えば、演算部５４による演算処理により求められる。 Note that since the method of obtaining the monitoring unit time is the same as the time threshold described in the first embodiment, the description thereof is omitted here. The monitoring unit time is obtained by, for example, calculation processing by the calculation unit 54.
　以上説明したように本実施形態によれば、プライミング動作が開始した時点から検出された気泡の体積の累積値に基づいてプライミング動作の終了を判定してユーザに通知する。この場合にも、上記第１の実施形態と同様の効果が得られる。 As described above, according to the present embodiment, the end of the priming operation is determined and notified to the user based on the accumulated value of the volume of the bubbles detected from the time when the priming operation is started. Also in this case, the same effect as the first embodiment can be obtained.
　なお、上述した図５の説明では、定速（プライミング液の流速が一定）でプライミング動作を行なう場合について説明したが、第１の実施形態と同様に、リズム式のプライミング動作の場合も同様である。 In the description of FIG. 5 described above, the case where the priming operation is performed at a constant speed (the flow rate of the priming liquid is constant) has been described, but the same applies to the case of the rhythmic priming operation as in the first embodiment. is there.
　このようなリズム式のプライミング動作の場合、本実施形態においては、監視単位時間をリズム変更タイミングに合わせて更新して設定される。例えば、プライミング液の流速が速くなる場合には、それに応じて監視単位時間を短くし、また、例えば、プライミング液の流速が遅くなる場合には、それに応じて監視単位時間を長くすれば良い。 In the case of such a rhythmic priming operation, in this embodiment, the monitoring unit time is updated and set in accordance with the rhythm change timing. For example, when the flow rate of the priming solution is increased, the monitoring unit time is shortened accordingly. For example, when the flow rate of the priming solution is decreased, the monitoring unit time is increased accordingly.
　［その他の実施形態］
　以上が本発明の代表的な実施形態の例であるが、本発明は、上記及び図面に示す実施形態に限定することなく、その要旨を変更しない範囲内で適宜変形して実施できるものである。 [Other Embodiments]
The above is an example of a typical embodiment of the present invention, but the present invention is not limited to the embodiment described above and shown in the drawings, and can be appropriately modified and implemented within the scope not changing the gist thereof. .
　例えば、上述した第１及び第２の実施形態においては、プライミング動作の終了を判定する場合について説明したが、これに加えて、プライミング動作の終了までの予測時間を算出する予測時間算出部（不図示）を更に設け、当該予測時間算出部により求められた当該予測時間を併せてユーザに通知するようにしても良い。この場合、気泡の検出結果に基づいて、時間の経過に従った気泡の減少度合いを求め、それに応じて予測時間を適宜更新（例えば、所定時間間隔毎に更新）して表示すれば良い。 For example, in the first and second embodiments described above, the case where the end of the priming operation is determined has been described, but in addition to this, a predicted time calculation unit that calculates the predicted time until the end of the priming operation (not (Not shown) may be further provided to notify the user of the predicted time obtained by the predicted time calculation unit. In this case, the bubble reduction degree with the passage of time may be obtained based on the bubble detection result, and the predicted time may be appropriately updated (for example, updated at predetermined time intervals) accordingly and displayed.
　　１０　　体外循環装置
　　１１　　コントローラ
　　１８　　気泡センサ
　　２１　　流量センサ
　　５１　　プライミング制御部
　　５２　　センサ値取得部
　　５３　　終了判定部
　　５４　　演算部
　　５５　　通知部 DESCRIPTION OF SYMBOLS 10 Extracorporeal circulation apparatus 11 Controller 18 Bubble sensor 21 Flow rate sensor 51 Priming control part 52 Sensor value acquisition part 53 End determination part 54 Calculation part 55 Notification part
　本発明は上記実施の形態に制限されるものではなく、本発明の精神及び範囲から離脱することなく、様々な変更及び変形が可能である。従って、本発明の範囲を公にするために、以下の請求項を添付する。 The present invention is not limited to the above embodiment, and various changes and modifications can be made without departing from the spirit and scope of the present invention. Therefore, in order to make the scope of the present invention public, the following claims are attached.
　本願は、２０１２年６月１５日提出の日本国特許出願特願２０１２-１３６２３７を基礎として優先権を主張するものであり、その記載内容の全てを、ここに援用する。 This application claims priority based on Japanese Patent Application No. 2012-136237 filed on June 15, 2012, the entire contents of which are incorporated herein by reference.

Claims (8)

  1. 　被検者の血液を循環回路を用いて体外で循環させる体外循環装置であって、
    　前記被検者の体内への前記循環回路の経路を遮断した状態で前記循環回路にプライミング液を循環させて前記循環回路内の気泡を除去するためのプライミング動作の実行を制御するプライミング制御手段と、
    　前記プライミング動作中に前記循環回路内の気泡を検出する検出手段と、
    　前記検出手段による気泡の検出結果の時間変化に基づいて前記プライミング動作の終了を判定する判定手段と、
    　前記判定手段により前記プライミング動作の終了と判定された場合に、その旨をユーザに通知する通知手段と
    　を備えることを特徴とする体外循環装置。     An extracorporeal circulation device that circulates the blood of a subject outside the body using a circulation circuit,
    Priming control means for controlling the execution of a priming operation to circulate priming liquid in the circulation circuit and remove bubbles in the circulation circuit in a state where the path of the circulation circuit to the body of the subject is blocked; ,
    Detecting means for detecting air bubbles in the circulation circuit during the priming operation;
    A determination unit that determines the end of the priming operation based on a change in time of a bubble detection result by the detection unit;
    An extracorporeal circulation apparatus comprising: notification means for notifying the user of the end of the priming operation by the determination means.
  2. 　前記判定手段は、
    　前記プライミング動作中に所定時間の間、気泡が検出されなかった場合、前記プライミング動作の終了と判定することを特徴とする請求項１に記載の体外循環装置。     The determination means includes
    2. The extracorporeal circulation device according to claim 1, wherein when the bubble is not detected for a predetermined time during the priming operation, it is determined that the priming operation is finished.
  3. 　前記判定手段は、
    　前記プライミング動作が開始した時点から検出された気泡の体積の累積値に基づいて、前記プライミング動作の終了と判定することを特徴とする請求項１に記載の体外循環装置。     The determination means includes
    The extracorporeal circulation device according to claim 1, wherein the end of the priming operation is determined based on a cumulative value of the volume of bubbles detected from the time when the priming operation is started.
  4. 　前記判定手段は、
    　前記プライミング動作中に、ある時点から過去の所定時間内における気泡の体積の増加率を示す第１の増加率と、前記プライミング動作が開始した時点から前記ある時点までの気泡の体積の増加率を示す第２の増加率とを繰り返し求める演算手段を備え、
    　前記第１の増加率を前記第２の増加率で除算することにより得られる値を収束度として求め、当該収束度が基準値以下となれば、前記プライミング動作の終了と判定することを特徴とする請求項３に記載の体外循環装置。     The determination means includes
    During the priming operation, a first increase rate indicating a rate of increase of the bubble volume within a predetermined time in the past from a certain time point, and a rate of increase of the bubble volume from the start point of the priming operation to the certain time point Calculating means for repeatedly obtaining the second increase rate shown,
    A value obtained by dividing the first increase rate by the second increase rate is obtained as a convergence, and if the convergence is below a reference value, it is determined that the priming operation is finished. The extracorporeal circulation apparatus according to claim 3.
  5. 　前記所定時間には、
    　プライミング液が循環回路内をｎ周するのに要する時間が設定されることを特徴とする請求項２又は４に記載の体外循環装置。     In the predetermined time,
    The extracorporeal circulation device according to claim 2 or 4, wherein a time required for the priming liquid to make n turns in the circulation circuit is set.
  6. 　前記プライミング制御手段は、
    　前記プライミング動作中に前記プライミング液の流速を変化させ、
    　前記所定時間は、
    　前記プライミング動作中に前記流速が変化された場合にはそれに応じて更新されることを特徴とする請求項５に記載の体外循環装置。     The priming control means includes
    The flow rate of the priming liquid is changed during the priming operation,
    The predetermined time is
    6. The extracorporeal circulation device according to claim 5, wherein when the flow velocity is changed during the priming operation, the extracorporeal circulation device is updated accordingly.
  7. 　前記検出手段による気泡の検出結果に基づいて前記プライミング動作が終了までの予測時間を算出する予測時間算出手段を更に備え、
    　前記通知手段は、
    　前記プライミング動作中に前記予測時間を表示することを特徴とする請求項１乃至６のいずれか１項に記載の体外循環装置。     Further comprising predicted time calculation means for calculating a predicted time until the priming operation is completed based on a detection result of bubbles by the detection means;
    The notification means includes
    The extracorporeal circulation apparatus according to claim 1, wherein the predicted time is displayed during the priming operation.
  8. 　被検者の血液を循環回路を用いて体外で循環させる体外循環装置であって、前記被検者の体内への前記循環回路の経路を遮断した状態で前記循環回路にプライミング液を循環させて前記循環回路内の気泡を除去するためのプライミング動作の実行を制御するプライミング制御手段と、前記プライミング動作中に前記循環回路内の気泡を検出する検出手段と、を備える体外循環装置におけるプライミング方法であって、
    　前記検出手段による気泡の検出結果の時間変化に基づいて前記プライミング動作の終了を判定する判定工程と、
    　前記判定工程において前記プライミング動作の終了と判定された場合に、その旨をユーザに通知する通知工程と
    　を備えることを特徴とする体外循環装置のプライミング方法。     An extracorporeal circulation device that circulates the blood of a subject outside the body using a circulation circuit, wherein a priming solution is circulated through the circulation circuit in a state where a path of the circulation circuit to the body of the subject is blocked. A priming method in an extracorporeal circulation apparatus comprising: a priming control unit that controls execution of a priming operation for removing bubbles in the circulation circuit; and a detection unit that detects bubbles in the circulation circuit during the priming operation. There,
    A determination step of determining the end of the priming operation based on a time change in the detection result of bubbles by the detection means;
    A priming method for an extracorporeal circulation device, comprising: a notification step of notifying the user of the end of the priming operation in the determination step.
PCT/JP2013/003674 2012-06-15 2013-06-12 Extracorporeal circulation device and priming method WO2013187055A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2014520925A JP5918364B2 (en) 2012-06-15 2013-06-12 Extracorporeal circulation device and priming method

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2012136237 2012-06-15
JP2012-136237 2012-06-15

Publications (1)

Publication Number Publication Date
WO2013187055A1 true WO2013187055A1 (en) 2013-12-19

Family

ID=49757900

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2013/003674 WO2013187055A1 (en) 2012-06-15 2013-06-12 Extracorporeal circulation device and priming method

Country Status (2)

Country Link
JP (1) JP5918364B2 (en)
WO (1) WO2013187055A1 (en)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS60153138U (en) * 1984-03-22 1985-10-12 横河電機株式会社 artificial dialysis machine
JP2005046404A (en) * 2003-07-30 2005-02-24 Jms Co Ltd Bubble detection system, and hemodialysis circuit equipped with the bubble detection system
JP2011136003A (en) * 2009-12-28 2011-07-14 Nikkiso Co Ltd Blood purifying device and priming method thereof

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5984892A (en) * 1996-09-16 1999-11-16 Minnesota Mining And Manufacturing Company Blood aspirator
JP2000233020A (en) * 1999-02-15 2000-08-29 Nikkiso Co Ltd Washing method and washing device for blood treating device
EP2119494A4 (en) * 2007-01-30 2013-01-09 Toray Industries Hollow-fiber membrane and hollow-fiber-membrane module having the same included therein
JP5498084B2 (en) * 2009-08-03 2014-05-21 日機装株式会社 Flow rate fluctuation monitoring device and biological component measuring device

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS60153138U (en) * 1984-03-22 1985-10-12 横河電機株式会社 artificial dialysis machine
JP2005046404A (en) * 2003-07-30 2005-02-24 Jms Co Ltd Bubble detection system, and hemodialysis circuit equipped with the bubble detection system
JP2011136003A (en) * 2009-12-28 2011-07-14 Nikkiso Co Ltd Blood purifying device and priming method thereof

Also Published As

Publication number Publication date
JPWO2013187055A1 (en) 2016-02-04
JP5918364B2 (en) 2016-05-18

Similar Documents

Publication Publication Date Title
JP6005844B2 (en) Circulation device and control method thereof
TWI450738B (en) Blood-purifying device
JP6517023B2 (en) Blood purification device
WO2004009155A1 (en) Blood treating apparatus and blood treating method
JP2006288625A (en) Unit and method for hemodialysis
US20160175508A1 (en) Blood purification apparatus
JP2018126523A (en) Extracorporeal circulation apparatus
JP5997368B2 (en) Circulation device and control method thereof
JP5301259B2 (en) Hemodialysis machine
JP5851616B2 (en) Control device, circulation device and control method
JP5914678B2 (en) Device for storing and filtering fluids and venting gas and hematoma aspirator based on devices that store and filter fluids and vent gas
JP5918364B2 (en) Extracorporeal circulation device and priming method
JP6170603B2 (en) Circulation device and control method thereof
JP5947450B2 (en) Circulation device, control device and information processing method
JP5852248B2 (en) Extracorporeal circulation device, control device and control method thereof
JP5913598B2 (en) Extracorporeal circulation device and operating method thereof
WO2014162358A1 (en) Extracorporeal circulation device
WO2014128763A1 (en) Circulation device, control device, and information processing method
WO2014128764A1 (en) Circulation device, control device, and information processing method
WO2014162359A1 (en) Extracorporeal circulation device, and control method and storage medium for extracorporeal circulation device
WO2014162328A1 (en) External circulatory device and control method

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 13805086

Country of ref document: EP

Kind code of ref document: A1

ENP Entry into the national phase

Ref document number: 2014520925

Country of ref document: JP

Kind code of ref document: A

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 13805086

Country of ref document: EP

Kind code of ref document: A1