WO2014128763A1 - Dispositif de circulation, dispositif de commande et procédé de traitement d'informations - Google Patents

Dispositif de circulation, dispositif de commande et procédé de traitement d'informations Download PDF

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Publication number
WO2014128763A1
WO2014128763A1 PCT/JP2013/001059 JP2013001059W WO2014128763A1 WO 2014128763 A1 WO2014128763 A1 WO 2014128763A1 JP 2013001059 W JP2013001059 W JP 2013001059W WO 2014128763 A1 WO2014128763 A1 WO 2014128763A1
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WO
WIPO (PCT)
Prior art keywords
bubble
time
unit
blood
value
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PCT/JP2013/001059
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English (en)
Japanese (ja)
Inventor
昭彦 八木
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テルモ株式会社
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Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Priority to PCT/JP2013/001059 priority Critical patent/WO2014128763A1/fr
Publication of WO2014128763A1 publication Critical patent/WO2014128763A1/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
    • A61M1/3626—Gas bubble detectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • 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
    • A61M1/3666—Cardiac or cardiopulmonary bypass, e.g. heart-lung machines

Definitions

  • the present invention relates to information processing technology in a circulation device.
  • a bubble sensor is provided in the circulation circuit to monitor whether or not bubbles are mixed in the blood sent to the subject.
  • the clamp is closed to avoid adverse effects on the subject due to the bubble, and blood supply to the subject is stopped.
  • bubbles that adversely affect the subject are not only bubbles having a predetermined size, but, for example, when they break up into small bubbles that flow continuously as a group of fine bubbles for a certain period of time.
  • bubble group adversely affects the subject.
  • the mixed bubbles break up and often flow in a group of many small bubbles, so that such small-sized bubbles can be detected, and It is desirable that the total amount of bubbles be monitored by cumulative addition.
  • the bubble sensor is usually configured to output a signal that lowers the level according to the size of the bubble.
  • the level of the output signal is small and is distinguished from noise. It is a difficult situation to do.
  • the present invention has been made in view of the above problems, and an object of the present invention is to make it possible to accurately detect bubbles having a small volume in a circulation device.
  • the circulation device has the following configuration. That is, A circulation device that circulates the blood of a subject outside the body using a circulation circuit, Detecting means arranged in the circulation circuit and outputting a signal whose level changes according to the size of each bubble mixed in the circulated blood; A calculation means for sequentially calculating a variance value per unit time of the signal output from the detection means; An extraction means for extracting a time zone from when the variance value per unit time calculated by the calculation means exceeds the first reference value to below the second reference value; And determining means for determining that each level change included in the signal output from the detecting means in the time zone extracted by the extracting means is a bubble.
  • FIG. 1 is a diagram showing an overall configuration of an extracorporeal circulation device according to an embodiment of the present invention.
  • FIG. 2 is a diagram illustrating an example of a functional configuration of the controller of the extracorporeal circulation apparatus.
  • FIG. 3 is a diagram illustrating an example of an output signal of the bubble sensor and a dispersion value of the output signal.
  • FIG. 4 is a diagram showing the change over time of the cumulative value of the volume of bubbles.
  • FIG. 5 is a flowchart showing the flow of the bubble amount calculation process in the controller.
  • FIG. 1 is a diagram illustrating an example of the overall configuration of an extracorporeal circulation device 100 according to an embodiment of the present invention.
  • the extracorporeal circulation device 100 is called PCPS (percutaneous cardiopulmonary support) and performs cardiopulmonary assist operations (extracorporeal circulation operation, priming operation).
  • the extracorporeal circulation apparatus 100 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 indicated by an arrow in the figure.
  • the priming operation refers to an operation of removing 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 artificial lung 113, an oxygen supply source 117, a catheter (venous side). 119, a catheter (arterial side) 120, a bubble sensor 114, a flow sensor 115, a blood filter 116, a branch line 118, and a clamp 122. These components are connected by a flexible tube or the like, and the lumen of the tube forms a flow path for blood or priming liquid.
  • 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 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 blood flowing in the circulation circuit 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 is operated when an automatic control mode for automatically performing a closing operation is set when it is determined that an abnormality that stops blood supply has occurred based on an output signal from the bubble sensor 114. Is possible.
  • the branch line 118 switches the flow path of the circulation circuit. Specifically, during an extracorporeal circulation operation in which 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 blood. 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.
  • the bubble sensor 114 is controlled to acquire an output signal from the bubble sensor 114, or the flow rate sensor 115 is controlled to acquire a flow rate value.
  • 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. Bubbles in the circulation circuit are discharged from the bubble discharge port or the like with this circulation.
  • the bubble sensor 114 may detect whether or not there is a function of flowing in the circulation circuit during the priming operation.
  • the user who confirms that the priming is completed switches the branch line 118 and constructs a circulation circuit that passes through the body of the subject 130 as shown in FIG. 1A. Thereby, the blood of the subject 130 is circulated extracorporeally.
  • the controller 110 has, as its functional configuration, a control unit (computer) 201, an operation unit 202, a display unit 203, a timer unit 204, a storage unit (computer-readable recording medium) 205, and an I / F unit 206. And a communication unit 207.
  • the control unit 201 includes, for example, a CPU (Central Processing Unit), a ROM (Read Only Memory), a RAM (Random Access Memory), and the like, and various programs for realizing the above-described cardiopulmonary assist operation are stored in the ROM. It is assumed that
  • the operation unit 202 is realized by, for example, various buttons and inputs an instruction from a medical worker.
  • the display unit 203 is realized by, for example, a display device such as a monitor (including an output unit that outputs an alarm sound), and displays various types of information to a medical worker. Note that a part or all of the operation unit 202 and the display unit 203 may be realized as a touch panel with an audio speaker, for example.
  • the timer unit 204 measures various times.
  • the storage unit 205 is realized by a ROM, a RAM, and the like, and is executed by the control unit 201 in the interlocking operation control mode, and is based on an output signal from the bubble sensor 114 during the extracorporeal circulation operation, and is a cumulative value of the volume of bubbles.
  • a program for functioning as the bubble amount calculation unit 210 for calculating the value is stored.
  • the output signal output from the bubble sensor 114 during the extracorporeal circulation operation is stored as the bubble data 211.
  • the details of the bubble amount calculation process realized by using the bubble data 211 acquired by the control unit 201 executing a program that functions as the bubble amount calculation unit 210 will be described later.
  • the storage unit 205 may be mounted in the control unit 201.
  • the I / F unit 206 exchanges various signals with an external device. Note that an output signal from the bubble sensor 114 or the like is taken into the controller 110 via the I / F unit 206. Further, the centrifugal pump 112, the clamp 122, and the like operate based on an instruction from the controller 110 via the I / F unit 206.
  • the communication unit 207 communicates with the communication unit 220 attached to the medical staff.
  • the communication between the communication unit 207 and the communication unit 220 may be short-range wireless communication such as Bluetooth (registered trademark) or wireless communication using a wireless LAN such as Wi-Fi.
  • FIG. 3 is a diagram for explaining the output signal from the bubble sensor 114 and the bubble detection logic based on the output signal.
  • the horizontal axis 3A in FIG. The elapsed time from the beginning is shown, and the vertical axis shows the output signal from the bubble sensor 114.
  • the horizontal axis 3B in FIG. 3 indicates the elapsed time since the bubble sensor 114 started detecting the bubble, and the vertical axis represents the unit time calculated based on the output signal from the bubble sensor 114.
  • the change of the dispersion value is shown.
  • the output signal from the bubble sensor 114 is constantly fluctuating, and the cause of the fluctuation is the decrease in the level of the output signal due to the passage of bubbles and the output signal accompanying various noises. And lowering the level.
  • the level drop of the output signal due to the passage of the bubble is proportional to the volume of the bubble passing through, and when a relatively large bubble passes, the level drop of the output signal becomes large, When the bubbles are mixed and mixed and passed as a large group of small bubbles, the level of the output signal is small, but the level is repeatedly reduced in a short time.
  • the level reduction of the output signal due to various noises is relatively small and is similar to the level reduction that occurs when a large number of bubble groups pass, but it is characterized by a single occurrence.
  • the dispersion value per unit time of the output signal is monitored and relatively large bubbles pass. Therefore, when the dispersion value temporarily exceeds the predetermined value, and when the dispersion value exceeds the predetermined value for a certain period of time due to the passage of many small bubbles, it is effective to determine that the bubble is a bubble. You can say that. Further, since the level drop of the output signal is small and occurs once, it can be said that it is effective to determine that the noise is large when the increase in the variance value is small.
  • the extracorporeal circulation apparatus 100 when the variance value per unit time is sequentially calculated based on the output signal of the bubble sensor 114, and the variance value exceeds the first reference value, the bubble It is determined that bubble generation has started, calculation of the volume of bubbles is started, and when the value falls below the second reference value, it is determined that generation of bubbles has stopped, and calculation of the volume of bubbles is terminated.
  • the dispersion value exceeds the first reference value, at time t 2, the dispersion value is lower than the second reference value.
  • the time period P 1 determines that the bubble has occurred, to extract the time zone P 1, in the time period P 1, the output signal to calculate the area of a region lower than a predetermined threshold value that Thus, a value (V 11 ) corresponding to the volume of the bubbles is calculated (3A in FIG. 3).
  • the variance value is greater than the first reference value
  • at time t 4 the variance value is less than the second reference value
  • at time t 5 and time t 7 the variance value is the first value, respectively. It exceeds the reference value
  • at time t 6 and time t 8 the variance value is below the second reference value. Therefore, it is determined that bubbles are generated in the time zones P 2 , P 3 , and P 4 .
  • the time zones P 2 , P 3 , and P 4 are extracted and the area corresponding to the volume of the bubble (V 12) is calculated by calculating the area of the region where the output signal is lower than the predetermined threshold value in the time zone. To V 20 ).
  • the bubbles mixed in the blood sent to the subject are singly divided into large-volume bubbles that adversely affect the subject and, as described above, are divided and the volume of each bubble is small.
  • the bubble that adversely affects the subject by flowing continuously for a certain period of time that is, if the group of divided bubbles is returned to the state of one mass before the division, the subject is adversely affected. Bubbles with a large volume).
  • the former bubble can be dealt with by monitoring the drop in the level of the output signal of the bubble sensor 114.
  • FIG. 4 is a diagram showing a time change of the accumulated value obtained by accumulating the calculation results when the value corresponding to the volume of the bubble is calculated in FIG.
  • the horizontal axis indicates the elapsed time from the start of detection of bubbles by the bubble sensor 114
  • the vertical axis indicates the cumulative value ⁇ V.
  • movement can be considered as operation
  • the clamp 122 may be closed to stop blood feeding, or only an alarm may be output.
  • the clamp 122 may be closed or an alarm may be output.
  • FIG. 5 is a flowchart showing the flow (information processing method) of the bubble amount calculation process by the bubble amount calculation unit 210.
  • step S501 it is determined whether or not a first reference value for detecting bubbles and a second reference value for ending volume calculation have been set. If it is determined in step S501 that the first reference value and the second reference value are not set, the process waits until the setting is completed.
  • step S502 acquisition of bubble data and storage in the storage unit 205 are started by starting reception of an output signal from the bubble sensor 114.
  • step S503 calculation of a variance value per unit time is started for the received output signal from the bubble sensor 114.
  • step S504 the calculated dispersion value per unit time is monitored and it is determined whether or not it exceeds the first reference value. If it is determined in step S504 that the value does not exceed the first reference value, the process proceeds to step S509.
  • step S504 determines whether the calculated dispersion value per unit time exceeds the first reference value. If it is determined in step S504 that the calculated dispersion value per unit time exceeds the first reference value, the process proceeds to step S505, and the bubble volume is calculated from the time when the calculated value exceeds the first reference value. Start. Specifically, by calculating the area of the region where the output signal is lower than a predetermined threshold for the level drop of the output signal that occurs after the time when the first reference value is exceeded, a value corresponding to the volume of the bubble is obtained. calculate.
  • step S506 the process proceeds to step S506, and the value corresponding to the bubble volume calculated in step S505 is added to the cumulative value ⁇ V.
  • step S507 it is determined whether or not the dispersion value per unit time is less than the second reference value. If it is determined that the dispersion value is not less than the second reference value, the process returns to step S505, and the volume of the bubble is determined. Continue to calculate the value corresponding to.
  • step S507 if it is determined in step S507 that the dispersion value per unit time is lower than the second reference value, the process proceeds to step S508, the calculation of the value corresponding to the bubble volume is stopped, and the process proceeds to step S509.
  • step S509 it is determined whether or not the extracorporeal circulation operation has been completed. If it is determined that the extracorporeal circulation operation has not been completed, the process returns to step S504 to continue monitoring the dispersion value per unit time.
  • step S509 if it is determined in step S509 that the extracorporeal circulation operation has ended, the bubble amount calculation process ends.
  • the extracorporeal circulation device 100 is configured to sequentially calculate the dispersion value per unit time based on the output signal of the bubble sensor and monitor the dispersion value.
  • the level drop is caused by the passage of the bubble. It was judged that it was a thing and it was set as the structure which calculates the volume of a bubble. Further, the calculation of the bubble volume is stopped when the calculated dispersion value falls below the second reference value.
  • the second reference value is provided.
  • the present invention is not limited to this, and when the dispersion value per unit time becomes zero, the volume calculation is stopped. Also good.
  • the predetermined threshold (fixed value) is used to calculate the value corresponding to the volume of the bubble.
  • the present invention is not limited to this, and the bubble is detected. It is also possible to calculate an average value of output signals in a non-period of time and use the average value (variable value) as a threshold value.
  • the bubble sensor that outputs a signal that lowers the level according to the size of the bubble is assumed.
  • the present invention is not limited to this, and the level changes according to the size of the bubble. Any bubble sensor that outputs a signal may be used.
  • the dispersion value per unit time of the output signal is calculated as a parameter for determining a bubble.
  • the present invention is not limited to this, and variations in the output signal are detected. Other parameters may be used as long as they are shown.

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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

L'invention concerne un dispositif de circulation dans lequel des bulles de petit volume peuvent être détectées avec une grande précision. La présente invention concerne un dispositif de circulation qui fait circuler le sang d'un sujet de manière extracorporelle à l'aide d'un circuit de circulation, et qui est équipé d'un détecteur de bulles, d'un moyen de calcul pour calculer la variance par unité de temps d'une sortie de signal par le capteur de bulles, d'un moyen d'extraction pour l'extraction de la période de temps à partir de laquelle la variation par unité de temps calculée par le moyen de calcul dépasse une première valeur de référence jusqu'à ce que la variance soit inférieure à une seconde valeur de référence, et un moyen d'évaluation pour l'évaluation comme une bulle de chacun des changements de niveau inclus dans la sortie de signal par les moyens de détection sur la période de temps extraite par le moyen d'extraction.
PCT/JP2013/001059 2013-02-25 2013-02-25 Dispositif de circulation, dispositif de commande et procédé de traitement d'informations WO2014128763A1 (fr)

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PCT/JP2013/001059 WO2014128763A1 (fr) 2013-02-25 2013-02-25 Dispositif de circulation, dispositif de commande et procédé de traitement d'informations

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2002131288A (ja) * 2000-10-24 2002-05-09 Toray Ind Inc 気泡検出クランパおよび人工透析装置
JP2005046404A (ja) * 2003-07-30 2005-02-24 Jms Co Ltd 気泡検出システム、該気泡検出システムを備えた血液透析回路
JP2005084017A (ja) * 2003-09-11 2005-03-31 Jms Co Ltd 気泡量の検出システムおよび該気泡量の検出システムを搭載した医療用装置
JP2012513285A (ja) * 2008-12-22 2012-06-14 カリディアンビーシーティー、インコーポレーテッド 気泡検出器を備えた血液処理装置

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2002131288A (ja) * 2000-10-24 2002-05-09 Toray Ind Inc 気泡検出クランパおよび人工透析装置
JP2005046404A (ja) * 2003-07-30 2005-02-24 Jms Co Ltd 気泡検出システム、該気泡検出システムを備えた血液透析回路
JP2005084017A (ja) * 2003-09-11 2005-03-31 Jms Co Ltd 気泡量の検出システムおよび該気泡量の検出システムを搭載した医療用装置
JP2012513285A (ja) * 2008-12-22 2012-06-14 カリディアンビーシーティー、インコーポレーテッド 気泡検出器を備えた血液処理装置

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