JP2013022021A - Plasma cleaning device and operation method of the same - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a plasma cleaning device capable of accurately detecting occurrence of hemolysis by using a hemolysis sensor to/from which a plasma flow path is attachable and detachable.SOLUTION: The plasma cleaning device 1 includes: a plasma separator 10 for separating plasma from blood; a plasma flow path 70 through which the plasma separated in the plasma separator 10 flows; a hemolysis sensor 80 to/from which the plasma flow path 70 is attachable and detachable, and which detects a transmission light quantity when light is transmitted through the plasma flow path 70; and a hemolysis determination control part 140 for determining occurrence of the hemolysis on the basis of the transmission light quantity detected by the hemolysis sensor 80. The hemolysis determination control part 140 initializes a lower limit threshold Lm of the transmission light quantity to be the reference of the occurrence of the hemolysis on the basis of the transmission light quantity La detected by the hemolysis sensor 80, and thereafter executes control so as to elevate the lower limit threshold Lm to follow the transmission light quantity when the detected transmission light quantity La increases and to keep the lower limit threshold Lm fixed when the detected transmission light quantity La decreases.

Description

  The present invention relates to a plasma purification device and a method for operating the plasma purification device.

  There is plasma exchange therapy in which blood is removed from a patient, plasma is separated from the blood, and the blood is purified and returned to the body. This plasma exchange therapy is performed using a plasma purification device, which supplies the patient's blood to a plasma separator having a separation membrane such as a hollow fiber membrane, and returns the blood from the plasma separator to the patient. A circuit and a plasma circuit for flowing the plasma separated by the plasma separator are provided (see Patent Document 1). In the plasma purification apparatus, a negative pressure is generated by a plasma pump of a plasma circuit, and plasma in the blood is separated by passing through a separation membrane of a plasma separator by the negative pressure.

JP 2010-125207 A JP 2010-172419 A

  By the way, in the said plasma purification apparatus, when plasma is isolate | separated with the separation membrane of a plasma separator, the hemolysis which the erythrocyte in blood breaks may generate | occur | produce. This means that the red blood cells in the patient's blood are damaged, and it is necessary to detect when hemolysis occurs. In order to detect the occurrence of hemolysis, it is conceivable to install a hemolysis sensor in the plasma flow path downstream of the plasma separator. The hemolysis sensor utilizes the increase in the amount of hemoglobin in the plasma when hemolysis occurs, and transmits light having a wavelength having a peak of the absorption spectrum of hemoglobin to the tube of the plasma flow path, and transmits the amount of transmitted light. It is conceivable to use an optical sensor that detects the occurrence of hemolysis. In this case, the occurrence of hemolysis is confirmed when the amount of transmitted light detected by the hemolysis sensor falls below a predetermined lower limit threshold of the amount of transmitted light.

  However, in the plasma purification treatment, the initial priming solution flows through the plasma flow path and is subsequently replaced with plasma. Since the fluid flowing in the plasma flow path fluctuates in this way and the transparency changes, it is conceivable that the determination of the occurrence of hemolysis is erroneous even if it is determined based on a certain lower threshold.

  Further, when a hemolysis sensor is provided in the plasma purification apparatus, it is necessary to attach a tube of the plasma channel to the hemolysis sensor when preparing for treatment. At this time, for example, there may be a dimensional error in the tube of the plasma flow path, or the operator may accidentally shift the fixing position of the tube. In this case, since the amount of transmitted light detected by the hemolysis sensor varies, it is conceivable that the occurrence of hemolysis is erroneously detected.

  In addition, although the technique which provides the optical sensor which detects blood leakage and hemolysis in the dialysis apparatus for performing a dialysis treatment is disclosed (refer patent document 2), this dialysis apparatus has the flow path and optical sensor of a dialysate. Preliminarily built in the device and presupposes that the positional relationship between the dialysate flow path and the optical sensor is constant, and cannot be used in a plasma purification apparatus in which the plasma flow path is attached to or detached from the hemolysis sensor. .

  The present invention has been made in view of the above points, and provides a plasma purification apparatus and a method for operating the plasma purification apparatus that can accurately detect the occurrence of hemolysis using a hemolysis sensor that can attach and detach a plasma flow path. For that purpose.

  To achieve the above object, the present invention provides a plasma purification device for purifying plasma components in blood taken from the body, the plasma separator for separating plasma from blood, and the plasma separator A plasma channel through which plasma flows, the plasma channel is detachable, a hemolysis sensor that detects hemolysis by detecting a transmitted light amount when light is transmitted through the blood channel, and detected by the hemolysis sensor A hemolysis determination control unit that determines the occurrence of hemolysis based on the amount of transmitted light based on whether or not the amount of transmitted light falls below a lower limit threshold value, wherein the lower limit threshold value of the transmitted light amount serving as a reference for the occurrence of hemolysis is set as the hemolysis sensor After that, when the detected transmitted light amount increases, the lower limit threshold is raised so as to follow the transmitted light amount, and the detected transmitted light amount decreases. When the controls said lower limit threshold value so as to maintain the lower threshold constant, comprising a hemolysis determination control unit, and a plasma purifying device.

  According to the present invention, the lower limit threshold value of the transmitted light amount is initially set based on the transmitted light amount detected by the hemolysis sensor. When the transmitted light amount increases, the lower limit threshold is increased, and when the transmitted light amount decreases, the lower limit threshold value is increased. Since the threshold value is kept constant, the lower limit threshold value of the transmitted light amount is changed according to the actually detected transmitted light amount. For this reason, for example, even when the liquid flowing in the plasma flow path changes from priming liquid to plasma, there is a dimensional error in the plasma flow path, or the plasma flow path is not properly attached to the hemolysis sensor, The occurrence of hemolysis can be detected properly regardless of these factors. In addition, since the amount of transmitted light decreases when hemolysis occurs, in the case of an increase in the amount of transmitted light irrelevant to the occurrence of hemolysis, the lower limit threshold is increased, and the amount of transmitted light that can be related to the occurrence of hemolysis is reduced. In this case, the lower limit threshold is kept constant. As a result, the lower threshold is appropriately changed according to the change in the amount of transmitted light, and the occurrence of hemolysis can be detected with higher accuracy.

  In addition, the hemolysis determination control unit resets the lower limit threshold value every 30 to 90 minutes from the initial setting of the lower limit threshold value based on the amount of transmitted light detected by the hemolysis sensor at the time. There may be.

  The lower limit threshold in the plasma purification apparatus may be initially set to a value that is 0.2 to 0.9 times the detected transmitted light amount.

  An invariable lower limit value may be set as the lower limit threshold value.

  The hemolysis determination control unit may initialize the lower limit threshold when the inside of the plasma channel is replaced with plasma from a priming solution.

  The hemolysis determination control unit may set the timing at which the inside of the plasma channel is replaced with plasma from the priming solution based on the amount of fluid flowing through the plasma channel.

  The hemolysis determination control unit may set the timing at which the inside of the plasma channel is replaced with the plasma from the priming solution based on the volume of the plasma separator.

  The hemolysis determination control unit may set the timing at which the inside of the plasma channel is replaced with plasma from the priming solution based on a change in the amount of transmitted light detected by the hemolysis sensor.

  The hemolysis determination control unit sets an invariable lower limit threshold of the amount of transmitted light when the priming solution is flowing in the plasma channel, and the transmitted light amount The occurrence of hemolysis may be determined by comparing the invariant lower threshold.

  The above plasma purification apparatus may output an alarm when the hemolysis determination control unit determines the occurrence of hemolysis.

  The present invention according to another aspect is a method of operating a plasma purification device for purifying plasma components in blood taken from the body, wherein the blood purification device separates plasma from blood, and the plasma A plasma channel through which plasma separated by the separator flows; a hemolysis sensor that detects the amount of transmitted light when the plasma channel is detachable and transmits light through the plasma channel; and is detected by the hemolysis sensor A hemolysis determination control unit that determines the occurrence of hemolysis based on whether or not the transmitted light amount falls below a lower limit threshold, and the lower limit threshold of the transmitted light amount is determined by the hemolysis sensor. Initially set based on the detected transmitted light amount, and thereafter, when the detected transmitted light amount increases, the lower limit threshold is increased to follow the transmitted light amount, and the detected transmitted light amount decreases. Sometimes, the hemolyzed determination control unit is operated so as to maintain the lower threshold constant, a method of operating a plasma purifying device.

  According to the present invention, the occurrence of hemolysis can be accurately detected in the plasma purification apparatus.

It is explanatory drawing which shows the outline of a structure of a plasma purification apparatus. It is explanatory drawing which shows the outline of a structure of a hemolysis sensor. It is a graph which shows the example of the fluctuation | variation of a detected transmitted light amount, and the relationship between a lower limit threshold value and a lower limit value. It is explanatory drawing which shows the outline of a structure of the plasma purification apparatus which performs simple plasma exchange therapy. It is explanatory drawing which shows the outline of a structure of the plasma purification apparatus which performs plasma adsorption therapy.

  Hereinafter, preferred embodiments of the present invention will be described with reference to the drawings. FIG. 1 is an explanatory diagram showing an outline of the configuration of the plasma purification apparatus 1 according to the present embodiment.

  The plasma purification apparatus 1 shown in FIG. 1 implements double filtration plasmapheresis (DFPP) among plasma purification therapies.

  The plasma purification apparatus 1 sends, for example, a blood circuit 11 that sends blood taken from a patient to the plasma separator 10 and returns it to the patient, and sends plasma separated from the blood by the plasma separator 10 to the plasma component separator 12. The plasma circuit 13 is returned to

  The blood circuit 11 has one end connected to the blood removal part of the patient and the other end connected to the inlet 10a of the plasma separator 10, and one end connected to the outlet 10b of the plasma separator 10, The other end has a blood return channel 21 connected to the blood return part of the patient. The blood removal flow path 20 and the blood return flow path 21 are configured by, for example, soft tubes. In the blood removal flow path 20, a blood pump 30 that handles the tube of the flow path from the outside and feeds it, a drip chamber 31 for discharging bubbles, a syringe pump 32 for injecting an anticoagulant into the blood circuit 11, etc. Is provided. The drip chamber 31 is provided with a pressure sensor 33 that measures, for example, the inlet pressure of the plasma separator 10. In the blood return channel 21, a drip chamber 40, a bubble detector 41, a clamp valve 42, a pressure sensor 43, and the like are provided.

  The plasma separator 10 has a hollow fiber membrane 50 as a separation membrane, for example. The blood flowing into the plasma separator 10 from the blood removal channel 20 flows through the primary side of the hollow fiber membrane 50, flows out into the blood return channel 21, and flows through the primary side of the hollow fiber membrane 50. Flows out to the secondary side of the hollow fiber membrane 50 and is separated.

  A pressure sensor 51 that detects the pressure on the secondary side of the hollow fiber membrane 50 is provided at the outlet 10 c on the secondary side of the hollow fiber membrane 50 of the plasma separator 10.

  The plasma circuit 11 includes a first plasma channel 70 having one end connected to the secondary outlet 10d of the hollow fiber membrane 50 of the plasma separator 10 and the other end connected to the inlet 12a of the plasma component separator 12. The second plasma channel 71 has one end connected to the outlet 12 c of the plasma component separator 12 and the other end connected to the blood return channel 21. The first plasma flow path 70 and the second plasma flow path 71 are constituted by, for example, soft tubes.

  In the first plasma channel 70, for example, a hemolysis sensor 80, a plasma pump 81, a drip chamber 82, a pressure sensor 83, and the like are provided. The plasma component separator 12 has, for example, a hollow fiber membrane 90 and can separate a predetermined pathogenic substance from plasma. For example, in the plasma component separator 12, plasma flows from the inlet 12 a to the primary side of the hollow fiber membrane 90 and flows out to the secondary side of the hollow fiber membrane 90 to separate pathogenic substances. The outlet 12b on the primary side of the hollow fiber membrane 90 of the plasma component separator 12 is connected to a waste liquid passage 101 provided with a waste liquid pump 100, and the pathogenic substance thus separated is discharged through the waste liquid passage 101. Is done. For example, a replacement fluid channel 111 that communicates with the replacement fluid bag 110 is connected to the second plasma channel 71. The replacement fluid channel 111 is provided with a replacement fluid pump 112.

  For example, as shown in FIG. 2, the hemolysis sensor 80 includes a light emitting unit 120, a light receiving unit 121, a support member 122 that supports and fixes them, and a sensor control unit 123. The tube of the first plasma channel 70 can be attached and detached between the light emitting unit 120 and the light receiving unit 121. The sensor control unit 123 controls the operations of the light emitting unit 120 and the light receiving unit 121 to cause the light emitting unit 120 to emit light having a predetermined wavelength (a wavelength having a peak of the absorption spectrum of hemoglobin). The light transmitted through the plasma channel 70 is received by the light receiving unit 121, and the amount of transmitted light can be detected. Information on the amount of transmitted light detected by the hemolysis sensor 80 can be output from the sensor control unit 123 to the control device 130 described later.

  The plasma purification device 1 is a control device 130 that executes the plasma exchange process by controlling the operation of each device such as the blood pump 30, the bubble detector 41, the plasma pump 81, the hemolysis sensor 80, the waste liquid pump 100, the replacement fluid pump 112, and the like. have. The control device 130 has the same CPU, memory, and the like as a general-purpose computer, and can execute a plasma exchange process by executing a program stored in the memory in advance.

  The control device 130 functions as a hemolysis determination control unit 140 that determines the occurrence of hemolysis based on the amount of transmitted light detected by the hemolysis sensor 80. The hemolysis determination control unit 140 sets the transmitted light amount lower limit threshold Lm (shown in FIG. 3) as a reference for the occurrence of hemolysis to the transmitted light amount detected by the hemolysis sensor 80 (hereinafter referred to as “detected transmitted light amount”). Based on the initial setting, the lower limit threshold Lm is increased so as to follow the transmitted light amount when the detected transmitted light amount increases, and the lower limit threshold Lm is controlled to be constant when the detected transmitted light amount decreases. The lower limit threshold Lm is set to a value 0.2 to 0.9 times the detected transmitted light amount.

  The initial setting of the lower limit threshold Lm is performed when the inside of the first plasma channel 70 is replaced with plasma from the priming solution. The timing at which the inside of the first plasma flow path 70 is replaced with the plasma from the priming liquid may be set based on the amount of liquid flowing in the first plasma flow path 70 or based on the volume of the plasma separator 10. Or may be set based on a change in the detected transmitted light amount.

  In addition, the hemolysis determination control unit 140 resets the lower limit threshold Lm based on the detected transmitted light amount at the elapse of a predetermined time T1, for example, 30 to 90 minutes after the initial setting of the lower limit threshold Lm. In addition, an invariable lower limit value Lc is set in advance as the lower limit threshold value Lm. When the lower limit threshold value Lm becomes lower than the invariable lower limit value Lc due to the initial setting or resetting, the lower limit value Lc is set to the lower limit threshold value Lm. Set as.

  Furthermore, the hemolysis determination control unit 140 sets a lower limit threshold value Lm that does not change the amount of transmitted light when the priming liquid is flowing in the first plasma flow path 70, and the priming liquid flows in the first plasma flow path 70. In the meantime, the occurrence of hemolysis is determined based on the detected permeation flow rate and the unchanged lower limit threshold Lm.

  The control device 130 has an alarm output unit 141, and outputs an alarm when the hemolysis determination control unit 140 determines the occurrence of hemolysis, that is, when the detected transmitted light amount falls below the lower limit threshold Lm.

  Next, an example of operation | movement of the plasma purification apparatus 1 comprised as mentioned above is demonstrated. In the preparatory stage before the plasma purification treatment is performed, the tube of the first plasma channel 70 is attached to the hemolysis sensor 80 as shown in FIG. Further, a priming process is performed in which the plasma separator 10, blood circuit 11, and plasma circuit 13 shown in FIG. 1 are replaced with a priming solution such as physiological saline.

  When the plasma purification treatment is started, in the blood circuit 11 shown in FIG. 1, the blood pump 30 is operated, and the blood taken out from the patient is sent to the plasma separator 10. Plasma in the blood of the plasma separator 10 flows from the primary side to the secondary side of the hollow fiber membrane 50 and is separated from the blood. The remaining blood is returned from the plasma separator 10 to the patient through the blood return channel 21. On the other hand, in the plasma circuit 13, the plasma pump 81 is operated, and the plasma separated by the plasma separator 10 passes through the hemolysis sensor 80 through the first plasma channel 70 and is sent to the plasma component separator 12. The plasma that has flowed into the plasma component separator 12 flows out from the primary side to the secondary side of the hollow fiber membrane 90, the pathogenic substance is separated by the hollow fiber membrane 90, and the second side passes into the second plasma channel 71. leak. The pathogenic substance is discharged from the plasma component separator 12 through the waste liquid channel 101. The plasma that has flowed out into the second plasma channel 71 is supplemented with the replacement fluid from the replacement fluid bag 110 and then sent to the blood return channel 21. The plasma sent to the blood return channel 21 merges with the blood from the plasma separator 10 and is returned to the patient.

  During the plasma purification treatment, the hemolysis sensor 80 operates to detect whether hemolysis has occurred in the first plasma channel 70 on the outlet side of the plasma separator 10. The determination of the occurrence of hemolysis is performed based on whether or not the detected transmitted light amount La (shown in FIG. 3) detected by the hemolysis sensor 80 falls below the lower limit threshold Lm. FIG. 3 shows an example of the detected transmitted light amount La at the time of blood purification treatment, and the lower limit threshold value Lm and the lower limit value Lc.

  Immediately after the start of the plasma purification treatment, the priming liquid filled in the plasma separator 10 or the like by the priming process flows through the first plasma channel 70, and the priming liquid is replaced with plasma (replacement period T0). Is set to an invariable lower limit threshold Lm. This invariable lower limit threshold Lm is set to a low value based on experiments. For example, the invariable lower limit threshold Lm at this time takes into account the tube size error of the first plasma channel 70, the error due to the attachment of the tube of the first plasma channel 70 to the hemolysis sensor 80, and the variation in hemoglobin concentration in blood. Then, the amount of transmitted light when the priming solution is replaced with plasma may be obtained by experiments, and set to a value (low value) with a margin for the amount of transmitted light. Further, the invariable lower limit threshold Lm may be set to a value when hemolysis that cannot be allowed is generated. In the replacement period T0, the detected transmitted light amount La gradually decreases.

  When the priming solution in the first plasma channel 70 is replaced with plasma, the lower limit threshold Lm is initialized at this time (replacement completion time ta). The initial lower limit threshold value Lm is set to a value 0.2 to 0.9 times the detected transmitted light amount La at the end of replacement ta. The timing at which the priming solution is replaced with plasma, that is, the replacement end time ta is set based on, for example, the amount of fluid that has flowed into the first plasma channel 70. For example, the flow rate setting value of the plasma pump 81 of the first blood flow channel 70 can be used to determine the total flow rate that has flowed in the first plasma flow channel 70 from the start of plasma purification treatment, and the total flow rate is the first plasma flow channel. The time required to reach the liquid amount of the priming liquid that should pass 70 is defined as ta at the end of replacement.

  The replacement end time ta may be set based on the volume of the plasma separator 10. In this case, for example, the hemolysis determination control unit 140 recognizes the volume of the plasma separator 10, and replaces the time when the priming solution in the plasma separator 10 completely flows through the first plasma channel 70 based on the volume. Let ta be the end time. The hemolysis determination control unit 140 may recognize the volume of the plasma separator 10 when the user inputs the volume, for example, or reads a code related to the volume previously attached to the plasma separator 10 with a reader. Thus, the volume of the plasma separator 10 may be recognized.

  Further, the replacement end time ta may be set based on a change in the detected transmitted light amount La. In this case, for example, the time when the transmitted light amount is detected by the hemolysis sensor 80 while the priming solution is flowing in the first plasma flow path 70 and the detected transmitted light amount has been reduced is defined as ta at the end of replacement.

  After completion of the initial setting, the lower limit threshold Lm is changed based on the detected transmitted light amount La. When the detected transmitted light amount La increases, the lower limit threshold Lm is increased so as to follow the transmitted light amount, and the detected transmitted light amount La decreases. When this happens, the lower limit threshold Lm is kept constant.

  Then, every time a predetermined time T1, for example, 30 to 90 minutes elapses from when the lower limit threshold Lm is initially set (replacement completion time ta), the lower limit threshold Lm is reset based on the detected transmitted light amount La at that time. That is, every time the predetermined time T1 elapses from the replacement end time ta, the lower limit threshold value Lm is set to a value 0.2 to 0.9 times the detected transmitted light amount La at the same time as in the initial setting described above. .

  In addition, the lower limit threshold Lm is set to an invariable lower limit Lc, and when the lower limit threshold Lm becomes lower than a predetermined invariable lower limit Lc by the above-described initial setting or resetting, the lower limit value Lc is set. Lc is used as the lower limit threshold Lm. Therefore, the lower limit threshold Lm does not fall below the invariable lower limit Lc.

  When the detected transmitted light amount La is lower than the lower limit threshold Lm (indicated by the dotted line of La line in FIG. 3), it is determined that hemolysis has occurred and an alarm is output.

  According to the present embodiment, the lower limit threshold value Lm of the transmitted light amount is initially set based on the transmitted light amount detected by the hemolysis sensor 80, and when the detected transmitted light amount La increases, the lower limit threshold value Lm is increased to detect and transmit light. When the light amount La decreases, the lower limit threshold value Lm is kept constant, so that the lower limit threshold value Lm of the transmitted light amount is changed according to the actually detected transmitted light amount. For this reason, for example, the liquid flowing through the first plasma channel 70 varies from the priming solution to plasma, the tube of the first plasma channel 70 has a dimensional error, or the first plasma channel with respect to the hemolysis sensor 80. Even when 70 tubes are not properly attached, the occurrence of hemolysis can be properly detected regardless of these factors. Further, since the detected transmitted light amount La decreases when hemolysis occurs, the lower limit threshold Lm is increased in the case of an increase in transmitted light amount unrelated to the occurrence of hemolysis, and the transmitted light amount that may be related to the occurrence of hemolysis. In the case of decrease, the lower threshold Lm is kept constant. As a result, the lower limit threshold Lm is appropriately changed according to the change in the detected transmitted light amount La, and the occurrence of hemolysis can be detected with higher accuracy.

  Since the lower limit threshold Lm is set to a value 0.2 to 0.9 times the detected transmitted light amount La, the accuracy of detection of the occurrence of hemolysis can be improved.

  By the way, when hemolysis occurs, the detected transmitted light amount La decreases at a certain speed (dotted line of La line in FIG. 3). Further, when the decrease rate of the detected transmitted light amount La is slower than that, it is highly likely that the detected transmitted light amount La is decreased due to other factors such as a change in temperature characteristics of the hemolysis sensor. Even when the detected transmitted light amount La gradually decreases due to other factors, the lower limit threshold Lm may be reached after a long time. In the present embodiment, every time 30 to 90 minutes of the predetermined period T1 have elapsed from the initial setting of the lower limit threshold Lm, the lower limit threshold Lm is reset based on the detected transmitted light amount La at that time. By doing this, the lower limit threshold Lm is reached only when the detected transmitted light amount La decreases at a certain high speed, and when the detected transmitted light amount La decreases more slowly, the lower limit threshold Lm is not reached. Since the case of factors other than the occurrence of hemolysis can be eliminated, the occurrence of hemolysis can be detected with higher accuracy.

  Since the invariable lower limit Lc is set as the lower limit threshold Lm, it is possible to prevent the lower limit threshold Lm from becoming extremely low. Thereby, generation | occurrence | production of hemolysis can be detected appropriately.

  Since the lower limit threshold Lm is initially set when the inside of the first plasma channel 70 is replaced with plasma from the priming solution (when replacement is complete ta), the occurrence of hemolysis after the plasma actually flows is appropriately detected. it can. Further, it is possible to prevent erroneous detection of hemolysis due to a decrease in the amount of transmitted light while the priming solution is replaced with plasma.

  Further, an invariable lower limit threshold Lm when the priming solution is flowing in the first plasma channel 70 (replacement period T0) is set, and while the priming solution is flowing in the first plasma channel 70, Since the occurrence of hemolysis is determined based on the detected transmitted light amount La and the unchanged lower limit threshold Lm, the occurrence of hemolysis in the replacement period T0 can also be detected. In addition, by setting the invariable lower limit threshold Lm low, it is possible to prevent erroneous detection of hemolysis due to a decrease or fluctuation in the detected transmitted light amount La during the replacement period T0.

  Since the timing at which the inside of the first plasma channel 70 is replaced with the plasma from the priming solution (replacement completion time ta) is set based on the amount of liquid flowing in the first plasma channel 70, the replacement time ta Can be easily detected. When the replacement completion time ta is set based on the capacity of the plasma separator 10, the replacement completion time ta can be accurately detected. Further, when the replacement completion time ta is set based on the change in the amount of transmitted light detected by the hemolysis sensor 80, the replacement completion time ta can be detected more accurately.

  The preferred embodiments of the present invention have been described above with reference to the accompanying drawings, but the present invention is not limited to such examples. It is obvious for those skilled in the art that various modifications or modifications can be conceived within the scope of the idea described in the claims, and these naturally belong to the technical scope of the present invention. It is understood.

  For example, in the above embodiment, the plasma purification apparatus 1 performs the double filtration plasma exchange therapy among the plasma exchange treatments. However, the plasma purification apparatus according to the present invention includes simple plasma exchange therapy and plasma adsorption therapy. It can be applied to other blood exchange treatments. In the plasma purification apparatus 1 that performs simple plasma exchange therapy, for example, as shown in FIG. 4, the first plasma channel 70 is not connected to the plasma component separator 12, and the plasma that passes through the first plasma channel 70 is used. Is drained, and fresh blood is replenished to the blood from the replacement fluid bag 110 through the second plasma channel 71. Further, in the plasma purification apparatus 1 that performs plasma adsorption therapy, for example, as shown in FIG. 5, the first plasma channel 70 is connected to the plasma adsorber 150, and the plasma from which the pathogenic substance is adsorbed and removed by the plasma adsorber 150. Is returned to the blood through the second plasma channel 71. Moreover, the plasma purification apparatus 1 does not necessarily perform a direct operation for determining the occurrence of hemolysis, and compares the detected transmitted light amount with the lower limit threshold value to give an alarm when the detected transmitted light amount falls below the lower limit threshold value. It is only necessary to substantially determine the occurrence of hemolysis.

  The present invention is useful for accurately detecting the occurrence of hemolysis in a plasma purification apparatus.

DESCRIPTION OF SYMBOLS 1 Plasma purification apparatus 10 Plasma separator 11 Blood circuit 12 Plasma component separator 13 Plasma circuit 20 Blood removal flow path 21 Blood return flow path 30 Blood pump 31 Drip chamber 32 Syringe pump 33 Pressure sensor 40 Drip chamber 41 Bubble detector 42 Clamp Valve 43 Pressure sensor 50 Hollow fiber membrane 51 Pressure sensor 80 Hemolysis sensor 81 Plasma pump 82 Drip chamber 83 Pressure sensor 90 Hollow fiber membrane 100 Waste fluid pump 101 Waste fluid channel 110 Supplement fluid bag 111 Supplement fluid channel 112 Supplement fluid pump 120 Light emitting unit 121 Light receiving unit 122 support member 123 sensor control unit 130 control device 140 hemolysis determination control unit 141 alarm output unit 150 plasma adsorber La detected transmitted light amount Lm lower threshold Lc lower limit T0 replacement period ta replacement end time T1 predetermined time

Claims (11)

A plasma purification device for purifying plasma components in blood taken from the body,
A plasma separator for separating plasma from blood;
A plasma channel through which the plasma separated by the plasma separator flows;
A hemolysis sensor, wherein the plasma flow channel is detachable, and detects a transmitted light amount when light is transmitted through the plasma flow channel;
A hemolysis determination control unit that determines the occurrence of hemolysis based on the transmitted light amount detected by the hemolysis sensor based on whether or not the transmitted light amount falls below a lower limit threshold value. After that, when the detected transmitted light amount is increased, the lower limit threshold is increased so as to follow the transmitted light amount, and the detected transmitted light amount is decreased. Sometimes, a plasma purification apparatus comprising: a hemolysis determination control unit that controls the lower threshold value so as to keep the lower threshold value constant.   The hemolysis determination control unit resets the lower limit threshold value every 30 to 90 minutes after the initial setting of the lower limit threshold value, based on the amount of transmitted light detected by the hemolysis sensor at the time. The plasma purification apparatus described in 1.   The plasma purification apparatus according to claim 1 or 2, wherein the lower limit threshold is set to a value 0.2 to 0.9 times the detected amount of transmitted light.   The plasma purification apparatus according to any one of claims 1 to 3, wherein an invariable lower limit value is set as the lower limit threshold value.   The plasma purification apparatus according to any one of claims 1 to 4, wherein the hemolysis determination control unit initially sets the lower limit threshold when the inside of the plasma channel is replaced with plasma from a priming solution.   The plasma purification apparatus according to claim 5, wherein the hemolysis determination control unit sets a timing at which the inside of the plasma channel is replaced with plasma from a priming solution based on the amount of fluid flowing in the plasma channel.   6. The plasma purification apparatus according to claim 5, wherein the hemolysis determination control unit sets a timing at which the inside of the plasma channel is replaced with priming liquid from plasma based on a capacity of the plasma separator.   The plasma according to claim 5, wherein the hemolysis determination control unit sets a timing at which the inside of the plasma channel is replaced with plasma from a priming solution based on a change in the amount of transmitted light detected by the hemolysis sensor. Purification equipment.   The hemolysis determination control unit sets an invariable lower limit threshold of the amount of transmitted light when the priming solution is flowing in the plasma channel, and the transmitted light amount The plasma purification apparatus according to any one of claims 1 to 8, wherein occurrence of hemolysis is determined by comparing the invariable lower limit threshold.   The plasma purification apparatus according to any one of claims 1 to 9, wherein an alarm is output when the occurrence of hemolysis is determined by the hemolysis determination control unit. A method of operating a plasma purification device for purifying plasma components in blood taken from the body,
The blood purification device is
A plasma separator for separating plasma from blood;
A plasma channel through which the plasma separated by the plasma separator flows;
A hemolysis sensor, wherein the plasma flow channel is detachable, and detects a transmitted light amount when light is transmitted through the plasma flow channel;
A hemolysis determination control unit that determines the occurrence of hemolysis based on whether or not the transmitted light amount is below a lower limit threshold based on the transmitted light amount detected by the hemolysis sensor,
The lower limit threshold value of the transmitted light amount is initially set based on the transmitted light amount detected by the hemolysis sensor. Thereafter, when the detected transmitted light amount increases, the lower threshold value is increased so as to follow the transmitted light amount. When the detected amount of transmitted light decreases, the hemolysis determination control unit operates so as to keep the lower limit threshold constant.