WO2014162335A1 - 循環装置及びその制御方法 - Google Patents
循環装置及びその制御方法 Download PDFInfo
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- WO2014162335A1 WO2014162335A1 PCT/JP2013/002231 JP2013002231W WO2014162335A1 WO 2014162335 A1 WO2014162335 A1 WO 2014162335A1 JP 2013002231 W JP2013002231 W JP 2013002231W WO 2014162335 A1 WO2014162335 A1 WO 2014162335A1
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- gas
- oxygen concentration
- blood
- gas supply
- oxygenator
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- 230000004087 circulation Effects 0.000 title claims abstract description 91
- 238000000034 method Methods 0.000 title claims description 40
- 239000007789 gas Substances 0.000 claims abstract description 151
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 claims abstract description 90
- 229910052760 oxygen Inorganic materials 0.000 claims abstract description 90
- 239000001301 oxygen Substances 0.000 claims abstract description 90
- 210000004072 lung Anatomy 0.000 claims abstract description 34
- 239000008280 blood Substances 0.000 claims description 59
- 210000004369 blood Anatomy 0.000 claims description 59
- 230000008569 process Effects 0.000 claims description 32
- 238000001514 detection method Methods 0.000 claims description 20
- 239000012528 membrane Substances 0.000 claims description 20
- 239000012530 fluid Substances 0.000 claims description 14
- 230000037452 priming Effects 0.000 description 27
- 238000012545 processing Methods 0.000 description 20
- CURLTUGMZLYLDI-UHFFFAOYSA-N Carbon dioxide Chemical compound O=C=O CURLTUGMZLYLDI-UHFFFAOYSA-N 0.000 description 12
- 239000007788 liquid Substances 0.000 description 11
- 238000004891 communication Methods 0.000 description 8
- 230000007423 decrease Effects 0.000 description 8
- 229910002092 carbon dioxide Inorganic materials 0.000 description 6
- 239000001569 carbon dioxide Substances 0.000 description 6
- 230000005856 abnormality Effects 0.000 description 4
- 230000002612 cardiopulmonary effect Effects 0.000 description 4
- 230000017531 blood circulation Effects 0.000 description 3
- 230000036770 blood supply Effects 0.000 description 3
- 210000003462 vein Anatomy 0.000 description 3
- 238000013500 data storage Methods 0.000 description 2
- 238000007599 discharging Methods 0.000 description 2
- 239000000243 solution Substances 0.000 description 2
- 230000007704 transition Effects 0.000 description 2
- 229910003798 SPO2 Inorganic materials 0.000 description 1
- 101100478210 Schizosaccharomyces pombe (strain 972 / ATCC 24843) spo2 gene Proteins 0.000 description 1
- QRSFFHRCBYCWBS-UHFFFAOYSA-N [O].[O] Chemical compound [O].[O] QRSFFHRCBYCWBS-UHFFFAOYSA-N 0.000 description 1
- 230000002159 abnormal effect Effects 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 238000007664 blowing Methods 0.000 description 1
- 238000007675 cardiac surgery Methods 0.000 description 1
- 238000009833 condensation Methods 0.000 description 1
- 230000005494 condensation Effects 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000002618 extracorporeal membrane oxygenation Methods 0.000 description 1
- 238000011010 flushing procedure Methods 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000012544 monitoring process Methods 0.000 description 1
- 239000002504 physiological saline solution Substances 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
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
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1698—Blood oxygenators with or without heat-exchangers
-
- 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
-
- 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
- A61M1/3667—Cardiac or cardiopulmonary bypass, e.g. heart-lung machines with assisted venous return
-
- 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
- A61M2202/00—Special media to be introduced, removed or treated
- A61M2202/02—Gases
- A61M2202/0208—Oxygen
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/18—General characteristics of the apparatus with alarm
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3327—Measuring
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3331—Pressure; Flow
- A61M2205/3334—Measuring or controlling the flow rate
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/75—General characteristics of the apparatus with filters
- A61M2205/7554—General characteristics of the apparatus with filters with means for unclogging or regenerating filters
Definitions
- the present invention relates to a circulation device and a control method thereof.
- An artificial lung is one of the elements that make up the extracorporeal circulation device. When blood comes into contact with air, it takes in oxygen and discharges carbon dioxide.
- the artificial lung does not directly contact blood and air, but has a structure in which a gas exchange membrane is interposed between them (for example, Patent Document 1).
- the oxygen exchange efficiency of the oxygenator fluctuates.
- This factor includes internal factors such as the material and structure of the gas exchange membrane and external factors such as temperature and humidity.
- the gas exchange membrane may have a structure in which a large number of minute holes are arranged. If the humidity is high, the exchange efficiency decreases. Therefore, usually, the display signal of the sensor that detects the blood oxygen concentration provided on the circulatory device is monitored on the display screen, and the supply capability of the gas blender device connected to the oxygenator is manually adjusted as necessary Is done.
- a gas blender device supplies a mixed gas of 100% oxygen and compressed air. The supply amount can be adjusted manually by opening and closing the valve (opening ratio or valve opening ratio).
- the opening rate of the valve of the gas blender device is increased to increase the amount of gas supplied per unit time (oxygen concentration).
- oxygen concentration exceeds a certain level, an operation of lowering the supply gas amount by lowering the opening ratio of the valve of the gas blender device is performed.
- the present invention has been made in view of the above problems.
- the present specification intends to provide a technique for monitoring an artificial lung in a circulatory device and maintaining it in a safe state without human intervention.
- 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, A detection means that is located downstream of the oxygenator installed on the circulation circuit and detects blood oxygen concentration after gas exchange in the oxygenator; Determination means for determining whether the blood oxygen concentration detected by the detection means is within a preset target range, exceeds the target range, or falls below the target range; A gas supply means for supplying a gas containing at least oxygen to the artificial lung, the supply amount per unit time being variable; Control means for controlling a gas supply amount by the gas supply means according to a determination result of the determination means.
- FIG. 1 is a figure which shows an example of the whole structure of the extracorporeal circulation apparatus 100 which concerns on one Embodiment of this invention.
- the extracorporeal circulation device 100 is used not only for extracorporeal circulation such as during cardiac surgery but also for auxiliary circulation procedures such as PCPS and ECMO, 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 a blood extracorporeal circuit
- the blood of the subject 130 is circulated extracorporeally using this circulation circuit.
- 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, a gas blender 117 that is an oxygen supply source, a catheter (vein side) 119, and a catheter ( (Arterial side) 120, bubble sensor 114, flow sensor 115, blood filter 116, branch line 118, clamp 122, and blood oxygen concentration sensor 125. 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 pump is not limited to the centrifugal pump, and a roller pump or the like may be used.
- the artificial lung 113 performs blood circulation and blood gas exchange (oxygen addition, carbon dioxide removal, etc.) (details will be described later).
- the gas blender 117 connects an oxygen cylinder and an air cylinder, and supplies the mixed gas to the artificial lung 113.
- the gas blender 117 has a structure capable of adjusting the amount of gas per unit time (hereinafter referred to as gas supply amount) supplied to the artificial lung 113 in accordance with a control signal from the controller 110.
- gas supply amount the amount of gas per unit time supplied to the artificial lung 113 in accordance with a control signal from the controller 110.
- the gas blender 117 in the embodiment has a drive system and a circuit for adjusting a valve opening rate (opening rate) of a bubble (not shown) in accordance with a signal from the controller 110.
- Vmin means a fully closed state, and is also a state before functioning as a circulation circuit.
- V0 indicates the valve opening rate when the blood oxygen concentration is in the normal range.
- V ⁇ is for lowering the supply amount by ⁇ V than V0, and is applied when the blood oxygen concentration exceeds the normal range.
- V + increases the supply amount by ⁇ V more than V0, and is applied when the blood oxygen concentration falls below the normal range.
- Vmax indicates a valve opening rate at the time of the flash process, and indicates a valve opening rate at which a gas supply sufficient to blow off the plasma fluid that has oozed onto the gas exchange membrane of the artificial lung 113 is supplied.
- the valve is in a fully open state, but it is not necessarily required to be fully open as long as the ability to blow off plasma fluid is obtained.
- the bubble sensor 114 detects bubbles contained in the priming liquid or blood flowing in the circulation circuit during the priming operation and 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 oxygen sensor 125 is located downstream of the oxygenator 113 and detects the oxygen concentration in the blood (more precisely, the oxygen saturation oxygen saturation SPO2).
- 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. Based on the output signal from the bubble sensor 114, the clamp 122 can automatically perform a closing operation in conjunction with it when it is determined that an abnormality that immediately stops blood feeding has occurred.
- 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 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 subject 130 by the branch line 118 is blocked by the branch line 118 (in other words, the circulation circuit passing through 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 when an abnormality that requires blood supply to be stopped is detected based on the output signal from the bubble sensor 114.
- the controller 110 also performs a process of adjusting the gas supply amount to the gas blender 117 according to the oxygen concentration detected by the oxygen sensor 125.
- the controller 110 controls the execution of the priming operation.
- a circulation circuit that does not pass through the body of the subject 130 is constructed by the branch line 118 as shown in 1b of FIG.
- the priming liquid supply source 121 is connected to the branch line 118, and the priming liquid is supplied from the priming liquid supply source 121 into the circulation circuit.
- the circulation circuit is filled with the priming liquid.
- the centrifugal pump 112 is driven by the control of the controller 110, and the priming liquid circulates in the circulation circuit a plurality of times. Bubbles in the circulation circuit are discharged from the bubble discharge port or the like with this circulation. Further, the bubble sensor 114 may detect the presence or absence of bubbles flowing in the circulation circuit during the priming operation.
- the user who confirms that the priming is completed stops the driving of the centrifugal pump, switches the branch line 118, and constructs a circulation circuit that passes through the body of the subject 130 as shown in FIG. Thereafter, the user operates the controller 110 to set a target flow rate and inputs an instruction to start extracorporeal circulation. As a result, the controller 110 drives the pump 112 based on the set information, so that the blood of the subject 130 is circulated extracorporeally. Further, the controller 110 sets the gas supply amount V0 as an initial value in order to start the gas supply to the gas blender 117.
- the oxygenator 113 performs gas exchange, that is, gas exchange processing such as oxygen addition and carbon dioxide removal according to the gas supplied from the gas blender 117, and supplies the blood after gas exchange downstream. Thereafter, the filtered blood is sent from the catheter (arterial side) 120 into the body of the subject 130 through the blood filter 116 and the like. The blood flow of the subject 130 from the catheter (vein side) 119 to the catheter (arterial side) 120 is continuously performed. In the extracorporeal circulation operation mode, processing according to signals from various sensors is performed.
- the clamp 122 is closed. Further, the controller 110 is controlled according to the oxygen concentration detected by the oxygen sensor 125 to adjust the gas exchange efficiency of the oxygenator 113 (details will be described later).
- the controller 110 includes, as its functional configuration, a control unit 201, an operation unit 202, a display unit 203, a timer unit 204, a storage unit (computer-readable recording medium) 205, an I / F unit 206, a communication unit, Unit 207.
- the control unit 201 performs control of the controller 110 and control of the circulation circuit, and includes a CPU (Central Processing Unit).
- CPU Central Processing Unit
- 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 such as a monitor (including an output unit that outputs an alarm sound), and displays various types of information (including a message) to the user. 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, for example, a ROM and a RAM, and a control program 210 for realizing an extracorporeal circulation operation mode for operating as a circulation device, and a detection for storing detection results detected by each sensor It has a data storage area 211.
- the control unit 201 executes the priming process described above, and subsequently inputs the target flow rate setting from the operation unit 202, and the I / F unit 206.
- the drive control of the pump 112 and the extracorporeal circulation process corresponding to the detection results of various sensors are executed.
- 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.
- the feature of the present embodiment is a process for maintaining good gas exchange of the artificial lung 113 during execution of the extracorporeal circulation operation mode after the priming process. Therefore, in the following, the extracorporeal circulation operation mode will be described focusing on this point.
- Outline of extracorporeal circulation operation mode based on output signal from oxygen sensor> An important factor for processing in the extracorporeal circulation apparatus is to circulate blood at a target flow rate.
- the feature of the extracorporeal circulation device in the embodiment is that the processing capability of the oxygenator 113 is evaluated by the oxygen sensor 125 and the gas blender 117 is controlled to maintain the gas exchange efficiency of the oxygenator 113 in a good state. There is in point to do. Therefore, the following description will focus on that point.
- FIG. 3 is a conceptual diagram of the artificial lung 113.
- the artificial lung 113 has a structure in which a portion through which blood flows and a portion through which gas supplied from the gas blender 117 flows are separated by a gas exchange membrane. By the action of the gas exchange membrane, oxygen contained in the gas supply path is taken into the blood and carbon dioxide in the blood is discharged to the gas supply path.
- a structure having a large number of the illustrated structures is formed.
- the controller 110 in the embodiment determines whether or not this gas exchange is normally performed based on the oxygen concentration detected by the oxygen sensor 125 located downstream of the oxygenator 113. Then, the controller 110 controls the gas blender 117 according to the oxygen concentration, thereby maintaining normal gas exchange of the artificial lung 113.
- thresholds for determining that gas exchange is normally performed are defined as T1 and T2 (where T1 ⁇ T2), and the oxygen concentration detected by the oxygen sensor 125 is defined as D.
- the controller 110 sets the gas supply amount of the gas blender 117 to V0.
- D ⁇ T1 the oxygen concentration is below the lower limit of the normal range. Therefore, the controller 110 causes the gas blender 117 to set the gas supply amount to V +, which is larger by ⁇ V, in order to increase the gas exchange rate.
- D> T2 the oxygen concentration exceeds the upper limit of the normal range. Therefore, the controller 110 causes the gas blender 117 to set the gas supply amount to V ⁇ , which is smaller by ⁇ V, in order to lower the gas exchange rate.
- the gas blender 117 is set to V0 again.
- the gas blender 117 drives a valve drive circuit (not shown) according to a signal from the controller, and adjusts the valve opening rate of the valve.
- the oxygen sensor 125 detects the oxygen concentration in the blood at intervals of about 50 ms. However, since the detection result includes a measurement error, it slightly fluctuates with respect to the time axis. In order to suppress this fluctuation, the controller 110 in the embodiment stores the detected oxygen concentration in the detection data storage area 211 in order to hold the latest ten oxygen concentrations obtained by the oxygen sensor 125, and the average value thereof. Is calculated as the current oxygen concentration D.
- the controller 110 determines that the flash process should be executed,
- the gas supply amount Vmax is set in order to inject the gas blender 117 with a gas sufficient to blow off the plasma fluid in the artificial lung 113.
- the flash process is performed even when the period is equal to or longer than a preset period. This is because it can be determined that a certain amount of plasma leak has occurred in the gas exchange membrane in the oxygenator 113 that the oxygen concentration D is continued from the threshold value T0 to less than T1.
- Vmax is continuously set for 3 minutes.
- the decrease in the gas exchange rate due to the plasma exchange on the gas exchange membrane is improved by the flush operation, and then the flush operation is performed after at least 3 hours have elapsed.
- the flash operation means that a high gas pressure is applied to the oxygenator, and there is a concern that the oxygenator 113 is burdened and the product life is shortened. Furthermore, if a gas pressure higher than necessary is continuously applied, there is a high possibility that bubbles are generated in the blood, and the gas tank of the gas blender 117 is consumed quickly.
- the flash operation is not performed again until a predetermined time (3 hours) has elapsed since the previous flash process.
- a predetermined time 3 hours
- the gas cylinder connected to or contained in the gas blender 117 is in a state of no remaining gas, Since an abnormal state such as gas leakage somewhere between the blender 117 and the artificial lung 113 is assumed, a warning alarm is generated in such a case.
- the warning alarm may be either a sound or a warning message display, or both.
- the control unit 201 When the priming process is finished and the extracorporeal circulation operation mode is started, the control unit 201 first causes the gas blender 117 to set the gas supply amount to “V0” in step S401. That is, in the state immediately before operating as a circulation circuit, the gas supply amount of the gas blender 117 is “Vmin”, and therefore, processing for setting it to “V0” is performed. As a result, the gas blender 117 starts supplying oxygen-containing gas to the oxygenator 113 with the set gas supply amount V0.
- step S402 determines whether or not there has been an operation on the operation unit 202 by the user. If it is determined that an instruction is input to the operation unit 202 by the user, the process proceeds to step S403, and processing according to the instruction is performed.
- the processing in step S403 includes an operation for stopping the warning alarm.
- step S404 the blood oxygen concentration D is detected by the oxygen sensor 125. As described above, this detection is performed at 50 ms intervals. In addition, as described above, the latest average value of about 10 including the current detection value of the oxygen oxygen sensor 125 is obtained as the current oxygen concentration D.
- step S405 it is determined whether or not the obtained oxygen concentration D exceeds the threshold value T2. If it is determined that the gas has been exceeded, this indicates that the gas exchange has been performed more than necessary, and thus the process proceeds to step S406, where the gas supply amount is set to “V ⁇ ” for the gas blender 117.
- step S407 it is determined in step S407 whether or not the oxygen concentration is below the threshold value T1. If not, it indicates that the oxygen concentration D is within the target range, so the process proceeds to step S408, and the gas supply amount “V0” is set to the gas blender 117. When the gas supply amount set this time is the same as the previous supply amount, the setting for the gas blender 117 may not be performed. The same applies to the following description.
- step S410 it is determined whether or not the oxygen concentration has fallen below the threshold value T0. If this determination is NO, the process proceeds to step S411, and it is determined whether or not the state of T0 ⁇ D ⁇ T1 has passed for a preset time. When no plasma leak occurs in the artificial lung 113, the oxygen concentration rises after an appropriate time when the gas supply amount is set to V +. Therefore, the determination in step S411 is No.
- the above is the processing when no plasma leak occurs in the artificial lung 113 or the amount of generation is small.
- FIG. 5 shows an example of the transition of blood oxygen concentration D.
- the gas supply amount is set to “V0” when the blood oxygen concentration D is not less than the threshold value T1 and not more than T2, and when D exceeds the threshold value T2, the gas supply amount is set to “V ⁇ ”.
- D is less than the threshold T1
- the gas supply amount is set to “V +”.
- the gas exchange membrane of the artificial lung 113 begins to be covered with plasma droplets and the gas exchange rate decreases.
- the gas supply amount is “V +”
- the oxygen concentration cannot be increased, and the oxygen concentration D is maintained at a low level or continues to decrease, and finally falls below the threshold value T0.
- the situation is determined in steps S410 and S411.
- step S410 it is determined in step S410 whether or not a predetermined time (3 hours in the embodiment) has elapsed since the previous flash process.
- the operation start time is authorized as the time of the previous flash processing. If it is determined that a predetermined time has elapsed since the last flush process, the oxygen concentration D is considered to have fallen below the threshold T0 because the gas exchange membrane of the artificial lung 113 is covered with plasma fluid. Since it is also scheduled, a flash process is executed in step S414. In this step S414, it is the same as the manual flash operation, and the gas supply amount is continuously set to “Vmax” for about 3 minutes.
- a period Pf in FIG. 5 is a period during which the flash process is performed.
- step S413 determines that the period Pi (see FIG. 5) from the previous flush process to the detection of the oxygen concentration D below the current threshold T0 is less than the predetermined time. Therefore, the process proceeds from step S413 to step S415, and a warning alarm is issued.
- step S412. if the state in which the oxygen concentration D is T0 ⁇ D ⁇ T1 continues for a preset time or longer, there is a strong suspicion of plasma leak, and thus the flash process is executed in step S412. .
- the extracorporeal circulation apparatus 100 it is possible to monitor the oxygenator in the circulation apparatus and maintain it in a safe state without human intervention.
- the plasma fluid causes a decrease in the gas exchange rate due to covering the gas exchange membrane of the oxygenator, it becomes possible to automatically perform the flush process, and the oxygenator can be returned to a normal state. It becomes possible.
- the embodiment when it is determined that the flash processing is performed, if the elapsed time from the previous flash processing is shorter than the scheduled time interval, it is determined that there is an abnormality and a warning alarm is generated. It is possible to prompt the user to check the circulation circuit, particularly around the oxygenator.
- the gas blender 117 has been described as being capable of five-stage control including the fully closed state of the bubble.
- a gas blender 117 that can be adjusted with a larger number of stages may be used. Therefore, the present invention is not limited.
- the present invention functions by the program which the control part 201 in the controller 110 which functions as a control apparatus of the extracorporeal circulation apparatus 100 performs. Therefore, it is clear that the present invention includes such a program as its category.
- the program is normally stored in a computer-readable storage medium such as a CDROM or a memory card and can be executed by installing it in the system, such a storage medium is also within the scope of the present invention. It is also clear that there is.
Abstract
Description
被検者の血液を循環回路を用いて体外で循環させる循環装置であって、
前記循環回路上に設置された人工肺の下流側に位置し、前記人工肺でガス交換を経た血中酸素濃度を検出する検出手段と、
該検出手段で検出された血中酸素濃度が、予め設定した目標範囲内にある、前記目標範囲を上まわる、或いは、前記目標範囲を下回るかを判定する判定手段と、
単位時間当たりの供給量が可変であって、少なくとも酸素を含むガスを前記人工肺に供給するガス供給手段と、
前記判定手段の判定結果に応じて前記ガス供給手段によるガス供給量を制御する制御手段とを有することを特徴とする。
<1.体外循環装置の全体構成>
はじめに本発明の一実施形態に係る体外循環装置の全体構成について説明する。図1の1aは、本発明の一実施形態に係る体外循環装置100の全体構成の一例を示す図である。
次に、図2を用いて、図1の1a,1bに示すコントローラ110の機能構成の一例について説明する。
体外循環装置における処理には、目標とする流量の血液の循環を行なうことも重要な要素である。しかし、実施形態における体外循環装置の特徴とする点は、人工肺113の処理能力を酸素センサ125により評価し、ガスブレンダ117を制御して人工肺113のガス交換の効率を良好な状態に維持する点にある。そこで、以下では、その点に絞って説明する。
以上の説明を踏まえ、実施形態に係る体外循環装置100におけるコントローラ110の体外循環動作モードの処理内容を図4のフローチャートに従って説明する。同図は、図2の制御プログラム210内の一部を表わすものである。以下では説明を単純化させるため、酸素センサ125で検出した酸素濃度に基づく処理に的を絞って説明する。
上記実施形態では、体外循環装置100の制御装置として機能するコントローラ110内の制御部201が実行するプログラムによって機能する。従って、本発明は、係るプログラムをその範疇とするのは明らかである。また、通常、プログラムはCDROMやメモリカード等の、コンピュータが読み取り可能な記憶媒体に記憶され、それをシステムにインストールすることで実行可能になるわけであるから、係る記憶媒体も本発明の範疇にあることも明らかである。
Claims (8)
- 被検者の血液を循環回路を用いて体外で循環させる循環装置であって、
前記循環回路上に設置された人工肺の下流側に位置し、前記人工肺でガス交換を経た血中酸素濃度を検出する検出手段と、
該検出手段で検出された血中酸素濃度が、予め設定した目標範囲内にある、前記目標範囲を上まわる、或いは、前記目標範囲を下回るかを判定する判定手段と、
単位時間当たりの供給量が可変であって、少なくとも酸素を含むガスを前記人工肺に供給するガス供給手段と、
前記判定手段の判定結果に応じて前記ガス供給手段によるガス供給量を制御する制御手段と
を有することを特徴とする循環装置。 - 前記判定手段は、前記検出手段が検出した酸素濃度が、前記目標範囲の下限よりも小さい閾値を下回ったか否かを更に判定し、
前記制御手段は、前記閾値を下回る酸素濃度が検出された場合には前記人工肺内のガス交換膜に血漿液が覆われたと見なし、前記ガス供給手段に対して前記血漿液を吹き飛ばすのに十分な量のガスを供給させることでフラッシュ処理を実行することを特徴とする請求項1に記載の循環装置。 - 前記制御手段は、前記閾値を下回る酸素濃度が検出されたことに起因して前記フラッシュ処理を実行得る際、前回のフラッシュ処理を行なってからの経過時間が、予め設定された時間に満たない場合には、警告エラーを発する手段を含むことを特徴とする請求項2に記載の循環装置。
- 人工肺と、単位時間当たりの供給量が可変であって少なくとも酸素を含むガスを前記人工肺に供給するガス供給手段とを有し、被検者の血液を循環回路を用いて体外で循環させる循環装置の制御方法であって、
前記循環回路上に設置された前記人工肺の下流側に位置する酸素濃度を検出する検出手段からの信号に基づき、前記人工肺でガス交換を経た血中酸素濃度を検出する検出工程と、
該検出工程で検出された血中酸素濃度が、予め設定した目標範囲内にある、前記目標範囲を上まわる、或いは、前記目標範囲を下回るかを判定する判定工程と、
該判定工程の判定結果に応じて前記ガス供給手段によるガス供給量を制御する制御工程と
を有することを特徴とする循環装置の制御方法。 - 前記判定工程では、前記検出工程が検出した酸素濃度が、前記目標範囲の下限よりも小さい閾値を下回ったか否かを更に判定し、
前記制御工程では、前記閾値を下回る酸素濃度が検出された場合には前記人工肺内のガス交換膜に血漿液が覆われたと見なし、前記ガス供給手段に対して前記血漿液を吹き飛ばすのに十分な量のガスを供給させることでフラッシュ処理を実行することを特徴とする請求項4に記載の循環装置の制御方法。 - 前記制御工程は、前記閾値を下回る酸素濃度が検出されたことに起因して前記フラッシュ処理を実行得る際、前回のフラッシュ処理を行なってからの経過時間が、予め設定された時間に満たない場合には、警告エラーを発する工程を含むことを特徴とする請求項5に記載の循環装置の制御方法。
- 循環装置におけるコンピュータに、請求項4に記載の方法の各工程を実行させるためのプログラム。
- 請求項7に記載のプログラムを格納したコンピュータが読取可能な記録媒体。
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