WO2021044545A1 - 血液浄化装置 - Google Patents

血液浄化装置 Download PDF

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Publication number
WO2021044545A1
WO2021044545A1 PCT/JP2019/034782 JP2019034782W WO2021044545A1 WO 2021044545 A1 WO2021044545 A1 WO 2021044545A1 JP 2019034782 W JP2019034782 W JP 2019034782W WO 2021044545 A1 WO2021044545 A1 WO 2021044545A1
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WIPO (PCT)
Prior art keywords
blood
pressure
flow path
clamp
patient
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PCT/JP2019/034782
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English (en)
French (fr)
Japanese (ja)
Inventor
勇作 西川
桂 三澤
芳彦 門田
靖浩 細江
Original Assignee
日本ライフライン株式会社
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.)
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Application filed by 日本ライフライン株式会社 filed Critical 日本ライフライン株式会社
Priority to PCT/JP2019/034782 priority Critical patent/WO2021044545A1/ja
Priority to CN201980099713.9A priority patent/CN114340692B/zh
Priority to JP2021543861A priority patent/JP7363904B2/ja
Publication of WO2021044545A1 publication Critical patent/WO2021044545A1/ja

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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
    • A61M1/14—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

Definitions

  • the present invention relates to a blood purification device that purifies blood taken out from a patient and returns the purified blood to the patient.
  • hemodialysis filtration treatment method As one of the treatment methods for purifying the blood taken out from the patient, for example, there is a hemodialysis filtration treatment method in which hemodialysis and blood filtration are used in combination. Such blood purification treatments are generally performed over a relatively long period of time (eg, 24 hours or more) from the perspective of preventing abrupt fluctuations in the patient's fluid balance.
  • An apparatus (blood purification apparatus) for carrying out such a treatment method is disclosed in, for example, Patent Document 1.
  • the blood purifying device is a device that purifies the blood taken out from the patient and returns the purified blood to the patient, and is a blood purifying device that purifies the blood taken out from the patient. And, a blood circuit having a blood circulation flow path from the patient to the patient via a blood purifier, a blood pump and a clamp arranged on the blood circulation flow path, and a pressure at a predetermined position on the blood circuit are measured.
  • the pressure measuring device, the warning unit that performs a predetermined warning operation to the outside of the above device, the operation of the blood pump and the open / closed state of the clamp are controlled respectively, and a warning is given according to the pressure measurement result by the pressure measuring device.
  • the control unit confirms whether or not the pressure fluctuation value is within the first range in the situation where the clamp is set to the open state while operating the blood pump, and the pressure fluctuation value is the first.
  • the absolute value of the pressure is equal to or higher than the first threshold value in the first confirmation process that controls the warning operation to be performed when the pressure is out of the range of, and in the situation where the clamp is set to the closed state while operating the blood pump.
  • the second confirmation process of controlling so that a warning operation is performed when the absolute value of the pressure does not increase above the first threshold value is executed.
  • the above warning is given.
  • the operation will be performed.
  • the warning operation is performed when the blood circuit is not attached to the clamp (non-attached state). Therefore, the occurrence of the above-mentioned kink state, clogged state, non-attached state of blood circuit, etc. can be easily confirmed (automatically on the blood purification device side) without visual inspection or the like.
  • the control unit performs the first and second confirmation processes, respectively, before performing the priming process, which is a pretreatment before taking out blood from the patient. You may want to do it. In such a case, the occurrence of the above-mentioned kink state, clogged state, non-attached state of blood circuit, etc. can be confirmed in the stage prior to the above-mentioned priming process, so that it can be confirmed at an early stage. As a result, the convenience is further improved.
  • the control unit is in a situation where the clamp is set to the closed state while the blood pump is stopped after the execution of the first and second confirmation processes and before the priming process is performed. , Check whether the pressure fluctuation value is within the second range, and control so that a warning operation is performed when the pressure fluctuation value is out of the second range.
  • the confirmation process of may be further executed.
  • the warning operation is performed. Will be struck. Therefore, the occurrence of a leak state or the like at such a stage can be easily confirmed (automatically on the blood purification device side) without visual inspection or the like, and as a result, the convenience is further improved.
  • control unit confirms whether or not the absolute value of the pressure increases to the second threshold value or more in the situation where the clamp is set to the closed state while operating the blood pump after the priming process is performed.
  • the fourth confirmation process for controlling the warning operation to be performed when the absolute value of the pressure does not increase to the second threshold value or more may be further executed.
  • the occurrence of the above-mentioned kink state, clogged state, non-attached state of blood circuit, etc. can be confirmed not only in the pre-stage but also in the post-stage of the priming process, so that the treatment for purifying the blood taken from the patient Can be reconfirmed (final confirmation) before the above is implemented.
  • the convenience is further improved.
  • a fifth confirmation process for controlling the warning operation to be performed when the pressure fluctuation value deviates from the third range may be further executed.
  • the warning operation is performed. Therefore, the occurrence of a leak state or the like at such a stage can be easily confirmed (automatically on the blood purification device side) without visual inspection or the like, and as a result, the convenience is further improved.
  • the flow rate in the blood pump during the confirmation process executed before the priming process is performed is the flow rate in the blood pump during the confirmation process executed after the priming process is performed.
  • it may be controlled to be larger.
  • the occurrence of the above-mentioned various states can be roughly confirmed, and in the post-stage of the priming process, the occurrence of the above-mentioned various states can be confirmed in detail (with high accuracy). ) You will be able to confirm. As a result, the convenience is further improved.
  • the pressures include, for example, a first pressure in the blood circulation flow path from the patient to the blood purifier.
  • the second pressure in the blood circulation flow path which is the pressure on the flow path from the blood purifier to the patient, and the pressure on the flow path of the blood circuit excluding the blood circulation flow path.
  • the pressure may include at least the second pressure among the first to third pressures.
  • the above-mentioned various confirmation processes are executed by using at least the pressure (second pressure) on the flow path (the vicinity to the patient) from the blood purifier to the patient. It becomes. As a result, the occurrence of the above-mentioned various states can be easily confirmed in the vicinity to the patient, so that the convenience can be further improved.
  • Examples of the clamp include a bubble clamp arranged on the flow path from the blood purifier to the patient (near portion leading to the patient) in the blood circulation flow path.
  • the blood purification device since the first and second confirmation processes are executed respectively, the above-mentioned kink state, clogged state, non-attached state of blood circuit, etc. Can be easily confirmed without visual inspection. Therefore, it is possible to improve convenience.
  • FIG. 1 It is a schematic diagram which shows the schematic structural example of the blood purification apparatus which concerns on one Embodiment of this invention. It is a block diagram which shows the structural example of the control part and the part related to the control part in the blood purification apparatus shown in FIG. It is a flow chart which shows the motion processing example at the time of the treatment which concerns on a comparative example. It is a flow chart which shows the motion processing example at the time of the treatment which concerns on embodiment. It is a flow chart which shows the detailed processing example of the pre-priming confirmation processing shown in FIG. It is a flow chart which shows the detailed processing example following FIG. It is a flow chart which shows the detailed processing example following FIG. It is a flow chart which shows the detailed processing example of the confirmation processing after priming shown in FIG. It is a flow chart which shows the detailed processing example following FIG. It is a flow chart which shows the motion processing example at the time of the treatment which concerns on the modification 1. It is a flow chart which shows the motion processing example at the time of the treatment which concerns on the
  • FIG. 1 schematically shows a schematic configuration example of a blood purification device (blood purification device 7) according to an embodiment of the present invention.
  • FIG. 2 is a block diagram showing a configuration example of a control unit (control unit 6 described later) and a portion related to the control unit in the blood purification device 7.
  • the blood purification device 7 is a device that purifies the blood taken out from the vein or artery of the patient 9 and returns the purified blood to the patient 9.
  • the blood purification device 7 is a continuous blood purification device for carrying out a hemodialysis filtration treatment method for a relatively long period of time. That is, in this blood purification device 7, as a treatment method for purifying blood, a hemodialysis filtration treatment method in which hemodialysis and blood filtration are used in combination is implemented.
  • the blood purifying device 7 includes a blood circuit including a blood circulation flow path 10, a dialysate flow path 20, a replacement fluid flow path 30, and a waste liquid flow path 40, and a blood purifier 11 , 16a, 16b, 46, a warning unit 5, and a control unit 6.
  • the blood purifier 11 is composed of a hemodialysis filter, and as shown in FIG. 1, the blood B1 taken out from the patient 9 is purified by using the above-mentioned hemodialysis filtration treatment method, and after purification. It is a device that discharges blood B2.
  • the blood purifier 11 is arranged on the blood circulation flow path 10 which constitutes a part of the blood circuit described above.
  • the blood circulation flow path 10 is a flow path from the patient 9 to the patient 9 via the blood purifier 11.
  • the blood B1 taken out from the patient 9 is supplied to the blood purifier 11, and the purified blood B2 is discharged from the blood purifier 11. Later, the blood B3 supplemented with the replacement fluid L3, which will be described later, is returned to the patient 9.
  • a blood return chamber 12, a blood pump 13, a bubble sensor 14, and a bubble clamp 15 are arranged, respectively.
  • the blood return chamber 12 is a portion on the blood circulation flow path 10 on the downstream side of the blood purifier 11 to which the replacement fluid flow path 30 described later is connected.
  • the replacement fluid L3 supplied from the replacement fluid flow path 30 is replenished to the blood B2 purified by the blood purifier 11, and the replenished blood B3 is the blood circulation flow path. It is designed to flow over 10.
  • the blood pump 13 is a device that controls the flow rate of blood B1 on the upstream side of the blood purifier 11 on the blood circulation flow path 10.
  • Various pumps can be used as the blood pump 13, but in the example of FIG. 1, a roller pump (rotary pump) that controls the flow rate according to the set rotation speed of the roller is used. ing.
  • the bubble sensor 14 is a sensor that detects bubbles on the downstream side of the blood purifier 11 (downstream side of the blood return chamber 12) on the blood circulation flow path 10. As shown in FIG. 2, the result of detecting bubbles by the bubble sensor 14 is output to the control unit 6 described later.
  • the bubble clamp 15 is arranged on the downstream side of the blood purifier 11 (downstream side of the blood return chamber 12) on the blood circulation flow path 10, and the result of detecting bubbles by the bubble sensor 14 It is a clamp that sets the blood circulation flow path 10 in the open state or the closed state according to the above. Specifically, for example, when a bubble is detected by the bubble sensor 14, the bubble clamp 15 is set to the closed state, so that the blood circulation flow path 10 is also set to the closed state. .. In addition, for example, in order to prevent the blood circuit (blood circulation flow path 10) from being accidentally removed from the bubble clamp 15 after the start of the treatment method for purifying the blood B1, such a thing is prevented. A locking mechanism for the purpose may be provided in the air bubble clamp 15.
  • the dialysate flow path 20 is a flow path for supplying the dialysate L2 to the blood purifier 11 which is used when carrying out the hemodialysis filtration treatment method.
  • a dialysate tank 21, a dialysate pump 23, a warmer 24, and a dialysate clamp 25 are arranged on such a dialysate flow path 20.
  • the dialysate tank 21 is a tank for storing the dialysate L2. As shown in FIG. 1, the dialysate L2 is supplied from the dialysate tank 21 to the dialysate flow path 20.
  • the dialysate pump 23 is a device that controls the flow rate of the dialysate L2 on the dialysate flow path 20.
  • various pumps can be used as in the blood pump 13 described above, but in the example of FIG. 1, a roller pump is used as in the blood pump 13.
  • the warmer 24 is a device that heats the dialysate L2 on the downstream side of the dialysate pump 23 on the dialysate flow path 20. Therefore, in the example of FIG. 1, the dialysate L2 appropriately heated by such a warmer 24 is supplied to the blood purifier 11.
  • the dialysate clamp 25 is arranged between the dialysate tank 21 and the dialysate pump 23 on the dialysate flow path 20, and the dialysate flow path 20 is in an open state or a closed state. It is a clamp to be set to. Specifically, when the dialysate clamp 25 is set to the open state or the closed state, the dialysate flow path 20 is also set to the open state or the closed state.
  • the replacement fluid flow path 30 is a flow path for replenishing the replacement fluid L3 containing the body fluid component to the blood B2 after purification by the blood purifier 11 via the blood return chamber 12 described above.
  • a replacement fluid tank 31, a replacement fluid pump 33, a warmer 34, and a replacement fluid clamp 35 are respectively arranged on such a replacement fluid flow path 30.
  • the replacement fluid tank 31 is a tank for storing the replacement fluid L3. As shown in FIG. 1, the replacement fluid L3 is supplied from the replacement fluid tank 31 to the replacement fluid flow path 30.
  • the replacement fluid pump 33 is a device that controls the flow rate of the replacement fluid L3 on the replacement fluid flow path 30.
  • various pumps can be used in the same manner as the blood pump 13 and the dialysate pump 23 described above, but in the example of FIG. 1, the same as the blood pump 13 and the dialysate pump 23. , Roller pumps are used.
  • the warmer 34 is a device that heats the replacement fluid L3 on the downstream side of the replacement fluid pump 33 on the replacement fluid flow path 30. Therefore, in the example of FIG. 1, the replacement fluid L3 appropriately heated by such a warmer 34 is supplied to the blood return chamber 12 described above.
  • the replacement fluid clamp 35 is arranged between the replacement fluid tank 31 and the replacement fluid pump 33 on the replacement fluid flow path 30, and is a clamp that sets the replacement fluid flow path 30 in the open state or the closed state. is there. Specifically, when the replacement fluid clamp 35 is set to the open state or the closed state, the replacement fluid flow path 30 is also set to the open state or the closed state.
  • the waste liquid flow path 40 is a flow path for discharging the waste liquid L4 generated when the blood B1 is purified by the blood purifier 11. As shown in FIG. 1, a discharge port 41, a waste liquid pump 43, and a waste liquid clamp 45 are arranged on such a waste liquid flow path 40, respectively.
  • the discharge port 41 is a portion where the waste liquid L4 flowing on the waste liquid flow path 40 is discharged to the outside of the blood purification device 7.
  • the waste liquid pump 43 is a device that controls the flow rate of the waste liquid L4 on the waste liquid flow path 40.
  • various pumps can be used as in the blood pump 13, dialysate pump 23, and replenishment pump 33 described above, but in the example of FIG. 1, the blood pump 13, dialysate, and dialysate can be used.
  • a roller pump is used.
  • the waste liquid clamp 45 is arranged between the waste liquid pump 43 and the discharge port 41 on the waste liquid flow path 40, and is a clamp that sets the waste liquid flow path 40 in an open state or a closed state. is there. Specifically, when the waste liquid clamp 45 is set to the open state or the closed state, the waste liquid flow path 40 is also set to the open state or the closed state.
  • the pressure measuring devices 16a, 16b, and 46 are devices (pressure sensors) that measure the pressure at a predetermined position on the blood circuit described above, respectively.
  • the pressure measuring device 16a measures the pressure (inlet pressure Pa) on the flow path from the patient 9 to the blood purifier 11 in the blood circulation flow path 10.
  • the pressure measuring device 16b measures the pressure (return blood pressure Pb) on the blood flow path 10 from the blood purifier 11 to the patient 9.
  • the pressure measuring device 46 measures the pressure on the flow path of the blood circuit excluding the blood circulation flow path 10 (in the example of FIG. 1, the filtration pressure Pc which is the pressure on the waste liquid flow path 40).
  • the inlet pressure Pa, the return blood pressure Pb, and the filtration pressure Pc measured by the pressure measuring instruments 16a, 16b, and 46 in this way are output to the control unit 6 described later, respectively. It has become like. Further, in various confirmation processes described later, for example, at least one of these inlet pressure Pa, return blood pressure Pb and filtration pressure Pc (or at least one of these return blood pressure Pb) is the pressure P. It has come to be used as. Therefore, in the following, for convenience, at least one of these inlet pressure Pa, return blood pressure Pb, and filtration pressure Pc will be referred to as pressure P, for example, as shown in FIG.
  • the inlet pressure Pa corresponds to a specific example of the "first pressure” in the present invention.
  • the return blood pressure Pb corresponds to a specific example of the "second pressure” in the present invention
  • the filtration pressure Pc corresponds to a specific example of the "third pressure” in the present invention.
  • the warning unit 5 is a part that performs a predetermined warning operation to the outside (user) of the blood purification device 7. Examples of such a warning operation include a predetermined audio output, a display output of a video or a character, a predetermined lamp lighting, or a combination of such an audio output, a display output, and a lamp lighting. Therefore, the warning unit 5 is configured by using, for example, a speaker, various types of displays, an alarm light, and the like.
  • Control unit 6 The control unit 6 is a part that performs various control operations and processing operations in the blood purification device 7, and is configured by using, for example, a microcomputer or the like.
  • the control unit 6 performs the following control operation as an example. That is, the control unit 6 operates the various pumps (blood pump 13, dialysate pump 23, replacement fluid pump 33 and waste liquid pump 43) described above, and the various clamps (bubble clamp 15, dialysate clamp 25, replacement fluid pump 43) described above. The open / closed state of the clamp 35 and the waste liquid clamp 45) is controlled respectively. Further, the control unit 6 is adapted to control the above-mentioned warning operation by the warning unit 5 according to the measurement result (measured pressure P) by the above-mentioned pressure measuring instruments 16a, 16b, 46.
  • control unit 6 executes various confirmation processes (confirmation processes S21 to S23, S44, S45, etc., which will be described later), although details will be described later. ing.
  • FIG. 3 is a flow chart showing an example of motion processing during treatment according to a comparative example.
  • Step S1 a process of attaching a blood circuit to the various clamps (bubble clamp 15, dialysate clamp 25, replacement fluid clamp 35, and waste fluid clamp 45) described above is performed (FIG. 3). Step S1).
  • the priming process S3 which is a pretreatment before taking out blood B1 from the patient 9, is performed.
  • physiological saline or the like is used for various flow paths (blood circulation flow path 10, dialysate flow path 20, replacement fluid flow path 30, and waste liquid flow path 40) on the blood circuit.
  • flow paths blood circulation flow path 10, dialysate flow path 20, replacement fluid flow path 30, and waste liquid flow path 40
  • cleaning treatment of various flow paths and discharge treatment of air air bubbles
  • a preparatory process for extracting blood B1 from patient 9 is performed (step S5). Specifically, a process of connecting the blood circuit to the patient 9 or the like is performed.
  • a blood purification treatment is performed using the above-mentioned hemodialysis filtration treatment method (step S6).
  • the blood B1 taken out from the vein or artery of the patient 9 is purified, and the purified blood (the blood B3 after being purified and replenished with the replacement fluid L3) is returned to the patient 9.
  • the purified blood (the blood B3 after being purified and replenished with the replacement fluid L3) is returned to the patient 9.
  • a series of operation processing examples according to the comparative example shown in FIG. 3 is completed.
  • the following confirmation work is performed between the above-mentioned step S1 and the priming process S3 (corresponding to step S92) or between the above-mentioned step S3 and the above-mentioned step S5 (corresponding to step S94).
  • it will be done visually. That is, for example, the work of visually confirming the kink state and the clogged state of the various flow paths on the blood circuit and the non-attached state of the blood circuit to the various clamps described above is visually performed.
  • FIG. 4 is a flow chart showing an example of motion processing during treatment according to the present embodiment.
  • the same steps as those of the operation processing example according to the comparative example shown in FIG. 3 are designated by the same reference numerals, and the description thereof will be omitted as appropriate.
  • step S1 in FIG. 4 blood is applied to various clamps (bubble clamp 15, dialysate clamp 25, replacement fluid clamp 35, and waste fluid clamp 45) as in the above comparative example.
  • the process of mounting the circuit is performed (step S1 in FIG. 4).
  • control unit 6 executes the pre-priming confirmation process S2, which will be described later.
  • control unit 6 executes the post-priming confirmation process S4 described later.
  • step S5 in FIG. 4 the preparatory process for performing the blood removal described above is performed.
  • step S6 in FIG. 4 the blood purification treatment is performed using the above-mentioned hemodialysis filtration treatment method.
  • FIGS. 5 to 9 show a flow chart showing a detailed processing example of the pre-priming confirmation processing S2. Further, FIGS. 8 and 9 show a flow chart showing a detailed processing example of the post-priming confirmation processing S4.
  • FIGS. 5 to 7 a case where the open / closed state of the bubble clamp 15 is controlled among the various clamps described above will be described.
  • pre-priming confirmation process S2 (B-1. Details of pre-priming confirmation process S2)
  • the control unit 6 performs the confirmation process S21 (FIG. 5), the confirmation process S22 (FIG. 6), and the confirmation process S23 (FIG. 7) described below, respectively. It is designed to be executed in order.
  • the confirmation process S21 corresponds to a specific example of the "first confirmation process” in the present invention. Further, the confirmation process S22 corresponds to a specific example of the "second confirmation process” in the present invention, and the confirmation process S23 corresponds to a specific example of the "third confirmation process” in the present invention.
  • control unit 6 determines whether or not the elapsed time ⁇ t counted by the timer is less than the predetermined time t21 (whether or not ⁇ t ⁇ t21 is satisfied) (step S213).
  • the predetermined time t21 is about 5 seconds.
  • step S213 N
  • the process proceeds to the confirmation process S22 (step S221 in FIG. 6) described later. ..
  • control unit 6 confirms whether or not the pressure P22 is equal to or less than the predetermined value PH1 in the conditional expression (2).
  • predetermined value ⁇ PL1 about -5 [mmHg] can be mentioned, and as an example, about 10 [mmHg] can be mentioned as the predetermined value ⁇ PH1.
  • predetermined value PH1 about 50 [mmHg] can be mentioned.
  • step S215: Y if it is determined that both the conditional expressions (1) and (2) are satisfied (step S215: Y), the process returns to step S213 described above.
  • step S215: N when it is determined that at least one of the conditional expressions (1) and (2) is not satisfied (step S215: N), the control unit 6 is set to perform the predetermined warning operation described above. , Control the warning unit 5 (step S216). That is, for example, when the fluctuation value of the pressure P (P22-P21) deviates from the first range, or when the pressure P22 is larger than the threshold value PH1, the warning operation is performed by the warning unit 5. Become. In this case, a series of operation processing examples according to the present embodiment shown in FIG. 4 ends.
  • the control unit 6 first sets the bubble clamp 15 in the closed state (step S221). Subsequently, the control unit 6 determines whether or not the elapsed time ⁇ t counted by the timer is less than the predetermined time t22 (whether or not ⁇ t ⁇ t22 is satisfied) (step S222).
  • the predetermined time t22 about 30 seconds can be mentioned.
  • the threshold value Pth1 corresponds to a specific example of the "first threshold value" in the present invention, and an example thereof is about 30 [mmHg].
  • step S224 N
  • the process returns to step S222 described above.
  • step S224: Y the process proceeds to the confirmation process S23 (step S230 in FIG. 7) described later.
  • step S222: N when it is determined that the elapsed time ⁇ t described above is equal to or greater than the predetermined time t22 ( ⁇ t ⁇ t22) (step S222: N), the control unit 6 performs the predetermined warning operation described above.
  • the warning unit 5 is controlled (step S225). That is, if the absolute value of the pressure P23 does not increase to the threshold value Pth1 or more even after the elapse of the predetermined time t22 or more, the warning operation by the warning unit 5 is performed. In this case, a series of operation processing examples according to the present embodiment shown in FIG. 4 ends.
  • step S232: N when it is determined that the elapsed time ⁇ t is the predetermined time t23 or less ( ⁇ t ⁇ t23) (step S232: N), the determination in step S232 is performed again.
  • the predetermined value ⁇ PH2 about 5 [mmHg] can be mentioned.
  • step S234: Y when it is determined that the fluctuation value of the pressure P (P24-P25) is equal to or less than the predetermined value ⁇ PH2 (step S234: Y), a series of pre-priming confirmation processes S2 shown in FIGS. Is completed, and the process proceeds to the priming process S3 shown in FIG.
  • step S234: N when it is determined that the fluctuation value of the pressure P (P24-P25) is larger than the predetermined value ⁇ PH2 ((P24-P25)> ⁇ PH2) (step S234: N), the control unit 6 has described the above.
  • the warning unit 5 is controlled so that a predetermined warning operation is performed (step S235). That is, when the fluctuation value of the pressure P (P24-P25) deviates from the above-mentioned second range, the warning operation by the warning unit 5 is performed. In this case, a series of operation processing examples according to the present embodiment shown in FIG. 4 ends.
  • the confirmation process regarding the absolute value of the pressure P is performed a plurality of times in this example. That is, in this example, the confirmation process S44a (steps S441 to S444 described later in FIG. 8) and the confirmation process S44b (steps S445 to S448 described later in FIG. 8) are performed twice to confirm the absolute value of the pressure P. Processing is being performed. However, the confirmation process regarding the absolute value of the pressure P may be performed only once (for example, only one of the above-mentioned confirmation processes S44a and S44b).
  • the confirmation process S44 corresponds to a specific example of the "fourth confirmation process” in the present invention. Further, the confirmation process S45 corresponds to a specific example of the "fifth confirmation process” in the present invention.
  • control unit 6 determines whether or not the elapsed time ⁇ t counted by the timer is less than the predetermined time t41 (whether or not ⁇ t ⁇ t41 is satisfied) (step S442).
  • the predetermined time t41 about 30 seconds can be mentioned.
  • step S442 N
  • the process proceeds to step S449 (warning operation) described later.
  • the threshold value Pth2a corresponds to a specific example of the "second threshold value" in the present invention, and an example thereof is about 250 [mmHg].
  • step S444 N
  • the process returns to step S442 described above.
  • step S444 Y
  • Fl flow rate
  • control unit 6 determines whether or not the elapsed time ⁇ t counted by the timer is less than the predetermined time t42 (whether or not ⁇ t ⁇ t42 is satisfied) (step S446).
  • the predetermined time t42 about 30 seconds can be mentioned.
  • step S446: N if it is determined that the elapsed time ⁇ t is the predetermined time t42 or more ( ⁇ t ⁇ t42) (step S446: N), the process proceeds to step S449 (warning operation) described later.
  • step S446 Y
  • the control unit 6 determines whether or not the pressure P42 is equal to or higher than a predetermined threshold value Pth2b (P42 ⁇ Pth2b) (step S448).
  • the threshold value Pth2b also corresponds to a specific example of the "second threshold value" in the present invention, and an example thereof is about 300 [mmHg].
  • step S448: N if it is determined that the pressure P42 is less than the threshold value Pth2b (P42 ⁇ Pth2b) (step S448: N), the process returns to step S446 described above. On the other hand, when it is determined that the pressure P42 is equal to or higher than the threshold value Pth2b (step S448: Y), the process proceeds to the confirmation process S45 (step S450 in FIG. 9) described later.
  • step S449 described above the control unit 6 controls the warning unit 5 so that the predetermined warning operation described above is performed. That is, when the absolute value of the pressure P41 does not increase above the threshold value Pth2a even after the elapse of the predetermined time t41 or more, or when the absolute value of the pressure P42 does not increase above the threshold value Pth2b even after the elapse of the predetermined time t42 or more. In that case, the warning operation by the warning unit 5 is performed. In such a case, a series of operation processing examples according to the present embodiment shown in FIG. 4 ends.
  • step S451: N when it is determined that the elapsed time ⁇ t is the predetermined time t43 or less ( ⁇ t ⁇ t43) (step S451: N), the determination in step S451 is performed again.
  • the predetermined value ⁇ PH3, about 20 [mmHg] can be mentioned.
  • step S453: Y when it is determined that the fluctuation value of the pressure P (P43-P44) is equal to or less than the predetermined value ⁇ PH3 (step S453: Y), a series of post-priming confirmation processes S4 shown in FIGS. Is completed, and the process proceeds to the preparatory process for blood removal (step S5) shown in FIG.
  • step S453: N when it is determined that the fluctuation value of the pressure P (P43-P44) is larger than the predetermined value ⁇ PH3 ((P43-P44)> ⁇ PH3) (step S453: N), the control unit 6 has described the above.
  • the warning unit 5 is controlled so that a predetermined warning operation is performed (step S454). That is, when the fluctuation value of the pressure P (P43-P44) deviates from the above-mentioned third range, the warning operation by the warning unit 5 is performed. In this case, a series of operation processing examples according to the present embodiment shown in FIG. 4 ends.
  • the above-mentioned confirmation processes S21 and S22 are executed before the priming process S3 (FIG. 4), which is a pretreatment before taking out the blood B1 from the patient 9, is performed.
  • the priming process S3 (FIG. 4)
  • the above-mentioned kink state, clogged state, non-attached state of blood circuit, etc. can be confirmed in the pre-stage of such priming process S3, it is possible to confirm in the early stage. As a result, in the present embodiment, it is possible to further improve the convenience.
  • the blood circuit is executed after the above-mentioned confirmation processes S21 and S22 are executed and before the priming process S3.
  • a warning operation will be performed. Therefore, the occurrence of a leak state or the like at such a stage can be easily confirmed (automatically on the blood purification device 7 side) without visual inspection or the like. Further improvement can be achieved.
  • the above-mentioned confirmation process S44 (FIG. 8) is further executed, so that the process is as follows. That is, since the occurrence of the above-mentioned kink state, clogged state, non-attached state of blood circuit, etc. can be confirmed not only in the pre-stage of the priming process S3 but also in the post-stage, the treatment for purifying the blood B1 taken out from the patient 9 is performed. It is possible to confirm again (final confirmation) before it is done. As a result, in the present embodiment, it is possible to further improve the convenience.
  • the flow rate Fh in the blood pump 13 during the confirmation process (confirmation process S21 to S23, etc.) executed before the priming process S3 is executed after the priming process S3 (confirmation process). Since the flow rates were made larger than the flow rates Fm and Fl in the blood pump 13 during the treatments S44, S45, etc. (Fh> (Fm, Fl)), the results are as follows. That is, in the pre-stage of the priming process S3, the occurrence of the above-mentioned various states can be roughly confirmed, and in the post-stage of the priming process S3, the occurrence of the above-mentioned various states can be confirmed in detail (with high accuracy). become. As a result, in the present embodiment, it is possible to further improve the convenience.
  • the pressures P used in the various confirmation processes (confirmation processes S21 to S23, S44, S45, etc.) described above include the above-mentioned inlet pressure Pa, return blood pressure Pb, and filtration pressure Pc. Since at least one of them is used, it becomes as follows. That is, as a result of executing the various confirmation processes described above based on the pressure at various points on the blood circuit, it is possible to further improve the convenience in the present embodiment. ..
  • the pressure P includes at least the return blood pressure Pb of the inlet pressure Pa, the return blood pressure Pb, and the filtration pressure Pc, and the bubble clamp 15 described above is used as the clamp. If you do so, it will be as follows. That is, using at least the return blood pressure Pb, which is the pressure on the flow path from the blood purifier 11 to the patient 9 (the vicinity of the patient 9), the various confirmation processes (confirmation processes S21 to S23, S44, S45, etc.) will be executed. As a result, the occurrence of the above-mentioned various states can be easily confirmed in the vicinity to the patient 9, and in such a case, the convenience can be further improved.
  • FIG. 10 is a flow chart showing an example of motion processing at the time of treatment according to the modified example 1. Further, FIG. 11 is a flow chart showing an example of motion processing at the time of treatment according to the modified example 2.
  • the shape, arrangement position, size, number, material, etc. of each member described in the above-described embodiment are not limited, and other shapes, arrangement positions, sizes, numbers, materials, etc. may be used.
  • the present invention is not limited to this example, and for example, the confirmation processes S21 and S22 may be executed in the reverse order, respectively.
  • the flow rate F in the blood pump 13 during the confirmation process (confirmation process S21 to S23, etc.) executed before the priming process S3 is subjected to the priming process.
  • the flow rate F or less in the blood pump 13 at the time of the confirmation process (confirmation process S44, S45, etc.) executed after S3 may be set.
  • various confirmation processes may be executed by using clamps other than the bubble clamp 15 (dialysate clamp 25, replacement fluid clamp 35 or waste fluid clamp 45). Good.
  • the replacement fluid flow path 30 is connected to the blood circulation flow path 10 on the blood discharge side of the blood purifier 11 (the replacement fluid L3 is added to the blood purified by the blood purifier 11). Is being replenished), but this is not the only example. That is, for example, the replacement fluid flow path 30 may be connected to the blood circulation flow path 10 on the blood introduction side of the blood purifier 11 (the replacement fluid L3 is replenished to the blood before being purified by the blood purifier 11). May be).
  • the blood purifier when the blood purifier is composed of a hemodialysis filter (when a hemodialysis filtration treatment method in which hemodialysis and blood filtration are used in combination is performed in the blood purification device).
  • the blood purifier may be composed of a blood filter (in the blood purifier, a treatment method using blood filtration is performed).
  • the blood purifier may be composed of a hemodialyzer (a treatment method using hemodialysis is carried out in the blood purifier).
  • it may be a blood purification device in which another treatment method (a treatment method using blood adsorption, blood separation, or the like) is used.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Urology & Nephrology (AREA)
  • Anesthesiology (AREA)
  • Vascular Medicine (AREA)
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PCT/JP2019/034782 2019-09-04 2019-09-04 血液浄化装置 WO2021044545A1 (ja)

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