WO2018180032A1 - 血液浄化装置及びその制御方法並びに脱血不良解消方法 - Google Patents
血液浄化装置及びその制御方法並びに脱血不良解消方法 Download PDFInfo
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- WO2018180032A1 WO2018180032A1 PCT/JP2018/006182 JP2018006182W WO2018180032A1 WO 2018180032 A1 WO2018180032 A1 WO 2018180032A1 JP 2018006182 W JP2018006182 W JP 2018006182W WO 2018180032 A1 WO2018180032 A1 WO 2018180032A1
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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
- A61M1/3639—Blood pressure control, pressure transducers specially adapted therefor
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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
- A61M1/3653—Interfaces between patient blood circulation and extra-corporal blood circuit
- A61M1/3656—Monitoring patency or flow at connection sites; Detecting disconnections
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- the present invention relates to a blood purification apparatus, a control method therefor, and a method for eliminating poor blood removal.
- blood purification treatment has been performed in which blood is taken out from a patient's body, and the etiological substances and specific white blood cells are removed from the blood and returned to the body.
- a blood circuit for circulating blood taken out from the body and returning it to the body, and a blood purifier having a treatment material such as an adsorbent and a separation material for removing / separating a specific substance; are used.
- the blood circuit of such a blood purification apparatus is connected to a patient's blood vessel via a puncture needle.
- a blood removal line for circulating blood taken from the patient to the blood purifier is connected to the artery A of the patient via a puncture needle 100 as shown in FIG.
- an automatic blood return device that returns blood remaining in the blood removal line to the patient via the puncture needle 100 by reversely rotating a blood pump provided in the blood flow path. (For example, refer to Patent Document 1).
- a hole 101 for drawing blood is formed at the distal end of the puncture needle 100, and blood removal is performed through the hole 101 or the distal end of the puncture needle 100 (artery A).
- the inner wall W of the artery A may stick to the hole 101 as shown by the broken line in FIG.
- the hole 101 of the puncture needle 100 is clogged by the coagulated mass, and there is a possibility that the blood removal failure may not be eliminated.
- the present invention has been made in view of such circumstances, and in a blood purification apparatus that performs blood removal via a puncture needle, it is effective for poor blood removal caused by a patient's blood vessel sticking to the hole of the puncture needle.
- the purpose is to eliminate it.
- a blood purification apparatus includes a blood removal line for circulating blood taken out from a patient to a blood purification device, a blood pump disposed on the blood removal line, and blood in the blood removal line.
- a pressure sensor that is arranged upstream of the pump and measures the pressure of blood flowing through the blood removal line, an infusion line that supplies the infusion fluid upstream of the blood pump of the blood removal line, and is connected to the infusion line
- a blood purification device comprising an infusion container, an on-off valve for opening and closing an infusion line, and a control unit for controlling a blood pump and an opening / closing means, the infusion container being arranged vertically above a patient
- the control unit opens the infusion line with the on-off valve when the pressure measured by the pressure sensor during operation of the blood pump becomes smaller than a predetermined value.
- the control method includes a blood removal line for circulating blood taken from a patient to a blood purifier, a blood pump disposed on the blood removal line, and an upstream side of the blood pump of the blood removal line.
- a pressure sensor that measures the pressure of blood that is disposed and circulates through the blood removal line, an infusion line that supplies the infusion fluid upstream of the blood pump of the blood removal line, an infusion container connected to the infusion line, and an infusion line
- a blood purification apparatus in which the infusion container is disposed vertically above the patient, and the pressure measured by the pressure sensor during operation of the blood pump is greater than a predetermined value.
- the on-off valve is controlled by the control unit so that the infusion line is opened by the on-off valve.
- the blood removal failure elimination method includes a blood removal line for circulating blood taken from a patient to a blood purifier, a blood pump disposed on the blood removal line, and a blood pump of the blood removal line.
- a pressure sensor that is disposed upstream and measures the pressure of blood flowing through the blood removal line; an infusion line that supplies the infusion fluid upstream of the blood pump of the blood removal line; and an infusion container connected to the infusion line;
- An infusion valve that opens and closes the infusion line, and the infusion container is disposed vertically above the patient. When the pressure becomes smaller than a predetermined value, the infusion line is opened with the on-off valve.
- the infusion line can be opened in the event that the patient's blood vessels stick to the patient and blood loss occurs.
- a predetermined value during the operation of the blood pump for example, the hole of the puncture needle provided at the tip of the blood removal line
- the infusion line can be opened in the event that the patient's blood vessels stick to the patient and blood loss occurs.
- the infusion in the infusion container arranged vertically above the patient can be naturally flowed through the infusion line and supplied to the blood removal line, and the blood in the blood removal line can be supplied to the patient side. Slight backflow is possible. Accordingly, it is possible to effectively eliminate the blood removal failure (for example, due to the patient's blood vessel sticking to the hole of the puncture needle).
- the blood in the blood removal line is slightly backflowed to the patient side using the difference in height between the infusion container and the patient without backflowing the blood by the blood pump. It is possible to prevent such a situation that the needle hole is clogged, and it is possible to safely eliminate the blood removal failure.
- control unit can stop or decelerate the operation of the blood pump when the pressure measured by the pressure sensor during operation of the blood pump becomes smaller than a predetermined value.
- the operation of the blood pump can be stopped or decelerated when the pressure upstream of the blood pump in the blood removal line becomes lower than a predetermined value during the operation of the blood pump. Therefore, it is possible to prevent the infusion supplied from the infusion container to the blood removal line by natural flow from flowing to the opposite side of the patient by the blood pump.
- the control unit stops or decelerates the operation of the blood pump and uses the on-off valve to infuse the infusion line. After that, the infusion line is closed with an on-off valve, and the operation of the blood pump can be resumed at a predetermined flow rate (for example, the flow rate before the operation of the blood pump is stopped or decelerated).
- a bubble detector can be provided in the infusion line or the blood removal line located between the patient and the infusion line.
- the control unit can close the infusion line with the on-off valve when the air bubble detector detects air bubbles when the infusion line is opened with the on-off valve.
- the infusion line when the infusion line is opened to eliminate poor blood removal, bubbles are detected by the bubble detector provided in the infusion line (or the blood removal line located between the patient and the infusion line). In this case, the infusion line can be closed. Therefore, it is possible to prevent bubbles from being included in blood or infusion fluid that flows back to the patient side.
- control unit can open the infusion line for a predetermined time with an on-off valve.
- the operation of the blood pump in the blood removal line becomes smaller than a predetermined value during the operation of the blood pump, the operation of the blood pump is stopped and the infusion line is kept for a predetermined time (for example, it can be opened for 1 to 2 seconds). That is, the open state of the infusion line can be controlled based on time.
- control unit can open the infusion line with the on-off valve until the pressure measured by the pressure sensor becomes a predetermined value or more.
- the operation of the blood pump in the blood removal line becomes smaller than a predetermined value during the operation of the blood pump, the operation of the blood pump is stopped and the pressure measured by the pressure sensor
- the infusion line can be opened until is equal to or greater than a predetermined value. That is, the open state of the infusion line can be controlled based on the pressure.
- FIG. 1 It is a block diagram for demonstrating the whole structure of the blood purification apparatus which concerns on embodiment of this invention. It is a figure for demonstrating the control method of the blood purification apparatus shown in FIG. 1 (the figure of the state by which the infusion line was obstruct
- the blood purification apparatus 1 is used for so-called leukocyte removal therapy (LCAP), and as shown in FIG. 1, a blood removal line 10, a blood purification device 20, a blood pump 30, a pressure sensor 40, An infusion line 50, an infusion container 60, an on-off valve 70, a control unit 80, a blood return line 90, and the like are provided.
- LCAP leukocyte removal therapy
- the blood removal line 10 is a flow path for circulating the blood taken out from the patient P to the blood purifier 20, and the blood return line 90 is a flow for returning the blood purified by the blood purifier 20 to the patient P. Road.
- the blood removal line 10 and the blood return line 90 constitute a blood circuit for circulating the blood taken out from the body of the patient P and returning it to the body.
- a puncture needle 100 as shown in FIG. 4 is provided at the distal end of the blood removal line 10, and the blood removal line 10 is connected to the artery of the patient P through the puncture needle 100.
- the blood return line 90 is connected to the vein of the patient P via a puncture needle (not shown).
- the blood purifier 20 purifies the activated white blood cells contained in the blood introduced from the blood inlet 21 by removing it with a filter, and discharges the purified blood from the blood outlet 22.
- a filter having an adsorbent that removes activated leukocytes can be used as the filter.
- the blood pump 30 is disposed on the blood removal line 10, and operates (forward rotation) under the control of the control unit 80, thereby allowing the patient P to pass through the blood removal line 10. It functions to distribute blood to the blood purifier 20.
- the control unit 80 stops the operation of the blood pump 30, the blood flow in the blood removal line 10 is stopped.
- the pressure sensor 40 is disposed upstream of the blood pump 30 in the blood removal line 10 and functions to measure the pressure of blood flowing through the blood removal line 10.
- the pressure measured by the pressure sensor 40 is sent to the control unit 80 and used for controlling the blood pump 30 and the on-off valve 70.
- the infusion line 50 is a flow path for supplying the infusion solution to the upstream side of the blood pump 30 of the blood removal line 10.
- the infusion line 50 in the present embodiment is provided with a bubble detector 51 that detects bubbles contained in the infusion flowing through the infusion line 50. Information relating to the detection result of the bubble detector 51 is sent to the control unit 80 and used to control the on-off valve 70.
- the infusion container 60 is a container for storing the infusion, and is connected to the tip of the infusion line 50.
- the infusion container 60 in the present embodiment is disposed vertically above the patient P. Thereby, when the infusion line 50 is opened by the on-off valve 70, the infusion moves from the infusion container 60 to the patient P side by natural flow.
- physiological saline or the like can be employed as an infusion.
- the on-off valve 70 is disposed on the infusion line 50 as shown in FIG. 1, and functions to open and close the infusion line 50 by operating under the control of the control unit 80.
- the infusion line 50 is opened by the opening / closing valve 70, the infusion fluid flows from the infusion container 60 to the blood removal line 10 via the infusion line 50, and the blood remaining in the blood removal line 10 is removed by this infusion. Returned to the P side. This eliminates poor blood removal.
- the control unit 80 includes, for example, a computer having a memory, a CPU (Central Processing Unit), and the like, and controls various devices of the blood purification apparatus 1 by the CPU executing various programs recorded in the memory.
- a computer having a memory, a CPU (Central Processing Unit), and the like, and controls various devices of the blood purification apparatus 1 by the CPU executing various programs recorded in the memory.
- CPU Central Processing Unit
- the control unit 80 stops the operation of the blood pump 30 and opens the on-off valve.
- the blood pump 30 and the on-off valve 70 are controlled so that the infusion line 50 is opened for a predetermined time (for example, 1 to 2 seconds).
- the control unit 80 immediately closes the infusion line 50 with the opening / closing valve 70 when the bubble detector 51 detects bubbles when the infusion line 50 is opened with the opening / closing valve 70.
- the controller 80 closes the infusion line 50 with the on-off valve 70 and restarts the operation of the blood pump 30 at a predetermined flow rate (for example, the flow rate before the blood pump 30 is stopped).
- the controller 80 measures the pressure of the blood removal line 10 with the pressure sensor 40 while closing the infusion line 50 with the on-off valve 70 and operating the blood pump 30.
- a predetermined value for example, ⁇ 200 mmHg
- the control unit 80 that has detected a blood removal failure stops the operation of the blood pump 30 and opens the infusion line 50 with the on-off valve 70 for a predetermined time (for example, 1 to 2 seconds). 30 and the on-off valve 70 are controlled.
- the infusion line 50 is opened by the on-off valve 70, the infusion fluid flows from the infusion container 60 to the blood removal line 10 via the infusion line 50, and the blood staying in the blood removal line 10 is caused by this infusion. Returned to This eliminates poor blood removal.
- the controller 80 immediately closes the infusion line 50 with the opening / closing valve 70 when the bubble detector 51 detects bubbles when the infusion line 50 is opened with the opening / closing valve 70. Thereby, it is possible to prevent bubbles from being included in blood (or infusion) that flows backward to the patient P side. Thereafter, the controller 80 closes the infusion line 50 with the on-off valve 70 and restarts the operation of the blood pump 30 at a predetermined flow rate.
- the blood purification apparatus 1 when the pressure on the upstream side of the blood pump 30 in the blood removal line 10 becomes smaller than a predetermined value during the operation of the blood pump 30 (for example, the blood removal line 10).
- a predetermined value for example, the blood removal line 10
- the operation of the blood pump 30 is stopped and the infusion line 50 is opened. it can.
- the infusion in the infusion container 60 arranged vertically above the patient P can be naturally flowed down via the infusion line 50 and supplied to the blood removal line 10.
- the blood can flow slightly back to the patient P side.
- the blood removal failure (for example, caused by the patient P's blood vessel sticking to the hole 101 of the puncture needle 100) can be effectively eliminated.
- the blood in the blood removal line 10 is slightly reversed toward the patient P side by utilizing the difference in height between the infusion container 60 and the patient P without causing the blood pump 30 to reverse the blood.
- the air bubble detector 51 provided in the infusion line 50 detects air bubbles.
- the infusion line 50 can be closed. Therefore, it is possible to prevent bubbles from being included in blood (or infusion) that flows back to the patient P side.
- the blood pump 30 in the blood removal line 10 becomes smaller than a predetermined value during the operation of the blood pump 30, the blood pump The operation of 30 can be stopped and the infusion line 50 can be opened for a predetermined time (for example, 1 to 2 seconds). That is, the open state of the infusion line 50 can be controlled based on time.
- a predetermined time for example, 1 to 2 seconds
- the blood pump 30 in the blood removal line 10 becomes smaller than a predetermined value during the operation of the blood pump 30, the blood pump The blood removal failure can be eliminated by stopping the operation of 30 and opening the infusion line 50, and then the operation of the blood pump 30 can be automatically restarted by closing the infusion line 50.
- the bubble detector 51 is provided in the infusion line 50 in the present embodiment.
- the blood removal line 10 positioned between the patient P and the infusion line 50.
- the bubble detector 11 can also be provided in.
- control part 80 in this embodiment is the example which open
- predetermined value namely, opening of the infusion line 50.
- the control mode of the on-off valve 70 is not limited to this.
- the control unit 80 uses the on-off valve 70 to infuse the infusion line 50 until the pressure measured by the pressure sensor 40 becomes a predetermined value (for example, 0 mmHg) or more. (That is, the open state of the infusion line 50 is controlled based on the pressure).
- control part 80 in this embodiment showed the example which opened the infusion line 50, after stopping the operation
- the infusion line 50 may be opened after the operation of the blood pump 30 is continued (or the speed is reduced without stopping completely).
- the present invention can also be applied to other blood purification apparatuses including an infusion line, an infusion container, an on-off valve, and the like.
- simple plasma exchange therapy PE
- DFPP double filtration plasma exchange therapy
- CHF continuous hemofiltration therapy
- CHD continuous hemodialysis therapy
- CHDF continuous hemodiafiltration therapy
- the present invention can also be applied to a blood purification apparatus provided with a blood purifier for filtration and diffusion.
- the present invention is not limited to the above-described embodiments, and those in which those skilled in the art appropriately modify the design are included in the scope of the present invention as long as they have the features of the present invention. .
- each element included in the embodiment and its arrangement, material, condition, shape, size, and the like are not limited to those illustrated, and can be appropriately changed.
- each element with which the said embodiment is provided can be combined as much as technically possible, and the combination of these is also included in the scope of the present invention as long as it includes the features of the present invention.
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Abstract
Description
10…脱血ライン
11…気泡検知器
20…血液浄化器
30…血液ポンプ
40…圧力センサ
50…輸液ライン
51…気泡検出器
60…輸液容器
70…開閉弁
80…制御部
P…患者
Claims (9)
- 患者から取り出した血液を血液浄化器に流通させる脱血ラインと、前記脱血ライン上に配置される血液ポンプと、前記脱血ラインの前記血液ポンプよりも上流側に配置されて前記脱血ラインを流通する血液の圧力を測定する圧力センサと、前記脱血ラインの前記血液ポンプよりも上流側に輸液を供給する輸液ラインと、前記輸液ラインに接続される輸液容器と、前記輸液ラインの開閉を行う開閉弁と、前記血液ポンプと前記開閉弁とを制御する制御部と、を備える血液浄化装置であって、
前記輸液容器は、前記患者よりも鉛直上方に配置されており、
前記制御部は、前記血液ポンプの運転時に前記圧力センサで測定した圧力が所定値よりも小さくなった場合に、前記開閉弁で前記輸液ラインを開放する、血液浄化装置。 - 前記制御部は、前記血液ポンプの運転時に前記圧力センサで測定した圧力が所定値よりも小さくなった場合に、前記血液ポンプの運転を停止又は減速させる、請求項1に記載の血液浄化装置。
- 前記制御部は、前記血液ポンプの運転時に前記圧力センサで測定した圧力が所定値よりも小さくなった場合に、前記血液ポンプの運転を停止又は減速させて前記開閉弁で前記輸液ラインを開放し、その後、前記開閉弁で前記輸液ラインを閉塞して前記血液ポンプの運転を所定の流量で再開させる、請求項1に記載の血液浄化装置。
- 前記所定の流量は、前記血液ポンプの運転を停止又は減速させる前の流量である、請求項3に記載の血液浄化装置。
- 前記輸液ライン又は前記患者と前記輸液ラインとの間に位置する前記脱血ラインに気泡検知器が設けられており、
前記制御部は、前記開閉弁で前記輸液ラインを開放したときに前記気泡検知器で気泡を検知した場合に、前記開閉弁で前記輸液ラインを閉塞する、請求項1から4の何れか一項に記載の血液浄化装置。 - 前記制御部は、前記開閉弁で前記輸液ラインを所定時間だけ開放する、請求項1から5の何れか一項に記載の血液浄化装置。
- 前記制御部は、前記圧力センサで測定した圧力が前記所定値以上になるまで前記開閉弁で前記輸液ラインを開放する、請求項1から5の何れか一項に記載の血液浄化装置。
- 患者から取り出した血液を血液浄化器に流通させる脱血ラインと、前記脱血ライン上に配置される血液ポンプと、前記脱血ラインの前記血液ポンプよりも上流側に配置されて前記脱血ラインを流通する血液の圧力を測定する圧力センサと、前記脱血ラインの前記血液ポンプよりも上流側に輸液を供給する輸液ラインと、前記輸液ラインに接続される輸液容器と、前記輸液ラインの開閉を行う開閉弁と、を備え、前記輸液容器が前記患者よりも鉛直上方に配置されている血液浄化装置の制御方法であって、
前記血液ポンプの運転時に前記圧力センサで測定した圧力が所定値よりも小さくなった場合に、前記開閉弁で前記輸液ラインを開放するように制御部で前記開閉弁を制御する、血液浄化装置の制御方法。 - 患者から取り出した血液を血液浄化器に流通させる脱血ラインと、前記脱血ライン上に配置される血液ポンプと、前記脱血ラインの前記血液ポンプよりも上流側に配置されて前記脱血ラインを流通する血液の圧力を測定する圧力センサと、前記脱血ラインの前記血液ポンプよりも上流側に輸液を供給する輸液ラインと、前記輸液ラインに接続される輸液容器と、前記輸液ラインの開閉を行う開閉弁と、を備え、前記輸液容器が前記患者よりも鉛直上方に配置されている血液浄化装置の脱血不良解消方法であって、
前記血液ポンプの運転時に前記圧力センサで測定した圧力が所定値よりも小さくなった場合に、前記開閉弁で前記輸液ラインを開放する、脱血不良解消方法。
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EP18776615.9A EP3603696B1 (en) | 2017-03-31 | 2018-02-21 | Blood purification device, control method thereof, and blood removal defect elimination method |
JP2019508777A JP6725749B2 (ja) | 2017-03-31 | 2018-02-21 | 血液浄化装置及びその制御方法並びに脱血不良解消方法 |
CN201880021011.4A CN110461389B (zh) | 2017-03-31 | 2018-02-21 | 血液净化装置及其控制方法以及脱血不良消除方法 |
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Publication number | Publication date |
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CN110461389A (zh) | 2019-11-15 |
JP6725749B2 (ja) | 2020-07-22 |
CN110461389B (zh) | 2022-02-25 |
JPWO2018180032A1 (ja) | 2019-11-07 |
EP3603696A4 (en) | 2020-03-18 |
EP3603696B1 (en) | 2022-09-28 |
EP3603696A1 (en) | 2020-02-05 |
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