JPH0257265A - Plasma separator and flow rate control method thereof - Google Patents

Abstract

PURPOSE:To efficiently separate plasma in the optimum flow rate by finely controlling the flow rates of a blood pump, a recirculation pump and a plasma pump corresponding to a drop blood-collecting pressure or a change of the filtering capacity of a plasma separator. CONSTITUTION:Blood is led out from a blood donor using a blood pump 26 to be guided to a plasma separator 10 and separated into a blood corpuscle component and a plasma component to collect the latter. At this time, the blood-collecting pressure from the blood donor is detected at every predetermined time using a pressure gauge and compared with set pressure to stepwise and repeatedly control the flow rate of the blood pump 25. By this method, the flow rate of the blood pump 26 can be finely and optimally controlled by the same method even when the variation of blood-collecting pressure is caused by the physiological condition of the blood donor 11 or there is such a mechanical cause that the leading end of a blood-collecting means touches a blood vessel.

Description

Detailed Description of the Invention [Field of Industrial Application] The present invention relates to a plasma separation device for separating and collecting plasma components from blood collected from a blood donor, and a method for controlling the flow rate thereof. A plasma separator and its flow rate that enable efficient plasma separation by controlling the flow rate of a pump constituting the separator to increase or decrease by a predetermined amount at predetermined time intervals according to blood pressure detected using a pressure gauge. Regarding control method.

[Background of the Invention] A donor pheresis device exists as a plasma separation device that collects blood from a blood donor and separates plasma components in the collected blood. This donor pheresis device connects a blood collection means such as a blood collection needle to a donor's blood vessel, stores the blood collected from the donor in a reservoir (blood storage section), and circulates it between the reservoir and a filter. This is a device that separates collected blood into blood cell components and plasma components.The blood cell component is returned to the donor's body, while the plasma component is stored for purposes such as treatment. has been done. In this case, in order to carry out the blood collection operation and plasma separation operation as described above, the donor pheresis device includes a blood pump for drawing out blood from the donor, and a blood pump for introducing the collected blood from the reservoir into the filter (plasma separator). Pumps such as a circulation pump and a plasma pump for extracting plasma components from the filter are provided at predetermined locations.

By the way, when using such a device, if the donor's blood pressure decreases, the flow rate of the blood pump that draws blood from the donor must be reduced. Furthermore, if the tip of the blood sampling means touches a blood vessel during blood sampling, the blood sampling pressure may drop rapidly, and the blood sampling volume may not be able to be secured.

Therefore, in order to deal with the above problem, for example, the venous pressure of the blood donor is detected, and when the venous pressure drops below the set pressure, the flow rate of the blood pump is reduced by a certain amount and blood collection is continued.
At the time when it is detected that the venous pressure has returned to the set pressure or higher, the flow rate of the blood pump is controlled to return to its original value.

However, in this control method, the flow rate of the blood pump to be adjusted differs depending on whether the cause of the drop in blood sampling blood pressure is due to a physiological condition such as a drop in the donor's blood pressure or when the tip of the blood sampling means touches a blood vessel. Nevertheless, the flow rate of the blood pump is varied by a fixed amount. Therefore, in the former case, it is appropriate to vary the flow rate of the blood pump in small increments, whereas in the latter case, it is not possible to respond to the need to vary the blood pump flow rate in large increments, resulting in the inconvenience that optimal flow control is impossible. It is occurring.

In addition, in this donor pheresis device, if the filter that makes up the plasma separator becomes clogged, it is necessary to reduce the flow rate of the circulation pump that introduces blood into the filter and the flow rate of the plasma pump that draws plasma components from the filter. occurs. In this case, the conventional method is to detect the filtration pressure of the filter, and when it falls below the set pressure, reduce the flow rate of the circulation pump, plasma pump, etc., and adjust the flow rate to the filter's filtration capacity in stages, or to detect the transmembrane pressure difference of the filter. However, when the pressure increases above the set pressure, a method is adopted in which the flow rate of the circulation pump, plasma pump, etc. is reduced.

However, in these methods, the key point is to determine how much the flow rate of each pump is to be reduced when the filtration pressure and the transmembrane pressure difference of the filter are below or above the set pressure. In this case, if the flow rate decrease is too large, filtration (separation of plasma components) will be performed below the filter's capacity, and if it is too small, it will not be possible to follow the decrease in filter capacity, making it difficult to optimally control the flow rate. Some inconveniences have been pointed out.

[Object of the Invention] The present invention has been made to overcome the above-mentioned disadvantages, and is to provide a blood pump, circulation pump,
It is an object of the present invention to provide a plasma separation device and its flow rate control method that control the flow rate of a plasma pump or the like and enable efficient plasma separation operation at an optimal flow rate.

[Means for Achieving the Object] In order to achieve the above object, the present invention provides a plasma separator having a blood collection section, a blood inflow port, a concentrated red blood cell outflow port, and a plasma outflow port, and a plasma separator having a blood collection section and a plasma separation port. A blood supply tube that communicates with the blood inlet of the device, a blood supply means provided on the blood supply tube, and a pressure detection means provided on the blood supply tube between the blood sampling section and the blood supply means;
Comparison means for comparing the detected pressure detected by the pressure detection means with a predetermined first set pressure and a predetermined second set pressure higher than the first set pressure;
When the comparison means detects that the detected pressure is lower than the first set pressure, the blood feeding means is stopped for a predetermined period of time, and then the blood feeding amount of the blood feeding means is decreased for a predetermined period of time, and the blood feeding means is driven. By repeating the operation, the detected pressure is
It is characterized by comprising a blood flow rate control means for controlling between set pressures.

Further, the present invention provides a blood collection section, a plasma separator having a blood inflow port, a concentrated red blood cell outflow port, and a plasma outflow port, a blood supply tube that communicates the blood collection section and the blood inflow port of the plasma separator, and a blood supply tube. a blood feeding means provided, a pressure detection means provided in a blood feeding tube between the blood sampling section and the blood feeding means, a detected pressure detected by the pressure detection means, a predetermined first set pressure, and the pressure detected by the pressure detection means; a comparison means for comparing a predetermined second set pressure higher than the first set pressure; and a blood feeding means for stopping the blood feeding means for a predetermined period of time when the comparison means detects that the detected pressure is higher than the second set pressure. and a blood supply flow rate control means for controlling the detected pressure between the first and second set pressures by repeating the operation of increasing the blood supply amount of the blood supply means by a predetermined amount and driving the blood supply means. It is characterized by

The present invention also provides a blood collection section, a plasma separator having a blood inlet, an a-thickness blood cell outflow port, and a plasma outflow port, a blood supply tube that communicates the blood collection section and the blood inflow port of the plasma separator, and a blood supply tube. a blood feeding means provided on the blood feeding means, a flow rate detection means provided on the blood feeding means, a comparison means for comparing the detected flow rate detected by the flow rate detection means and a predetermined set flow rate, and a comparison result by the comparison means. blood supply flow rate control means for controlling the blood supply volume of the blood supply means to increase the blood supply volume of the blood supply means when the detected flow rate is lower than the set flow rate and to decrease the volume of blood supply of the blood supply means when the detected flow rate is higher than the set flow rate; It is characterized by comprising:

The present invention also provides a plasma separator having a blood inlet, a blood cell outlet and a plasma outlet, a first blood supply tube communicating with the blood inlet of the plasma separator, and a plasma separator provided in the first blood supply tube. a second blood supply tube communicating with the concentrated red blood cell outflow port of the plasma separator; and a first pressure detection means provided in the first blood supply tube between the blood supply means and the plasma separator. , a second pressure detecting means provided in the second blood supply tube, a second detected pressure detected by the second pressure detecting means, a predetermined first set pressure, and a pressure higher than the first set pressure. a lower predetermined second set pressure, or a difference between the first detected pressure detected by the first pressure detection means and the second detected pressure and a predetermined third set pressure; Said third
a comparison means for comparing a predetermined fourth set pressure lower than the set pressure; and when the comparison means detects that the second detected pressure is higher than the first set pressure, or If it is detected that the difference between the second detected pressure and the third set pressure is higher than the third set pressure, the blood feeding means is stopped for a predetermined period of time, and then the blood feeding amount of the blood feeding means is reduced by a predetermined amount and the blood feeding means is driven. By repeating this operation, the second detected pressure becomes the first
, a blood flow rate control means for controlling the pressure to be between the second set pressure, or controlling the difference between the first detected pressure and the second detected pressure to be between the third and fourth set pressures.

The present invention also provides a plasma separator having a blood inflow port, a concentrated red blood cell outflow port, and a plasma outflow port, a first feeding tube communicating with the blood inflow port of the plasma separator, and a plasma separator provided in the first feeding tube. a blood feeding means, a second feeding tube communicating with the concentrated red blood cell outflow port of the plasma separator, and a first pressure detection means provided in the first feeding tube between the blood feeding means and the plasma separator; a second pressure detection means provided in the second blood supply tube; a second detected pressure detected by the second pressure detection means; a predetermined first set pressure; and a preset pressure lower than the first set pressure. A predetermined second set pressure is compared, or the difference between the first detected pressure detected by the first pressure detection means and the second detected pressure is compared with a predetermined third set pressure and the third set pressure. 3
a comparison means for comparing a predetermined fourth set pressure that is lower than the set pressure; When it is detected that the difference between the second detection pressure and the fourth set pressure is lower than the fourth set pressure, the blood feeding means is stopped for a predetermined period of time, and then the amount of blood fed by the blood feeding means is increased by a predetermined amount. By repeating the driving operation, the second detected pressure is controlled between the first and second set pressures, or the difference between the first detected pressure and the second detected pressure is controlled between the third and fourth set pressures. It is characterized by comprising a blood flow control means.

The present invention also provides a plasma separator having a blood inlet, a concentrated red blood cell outlet, and a plasma outlet, a first blood supply tube communicating with the plasma outlet, and a blood supply means provided in the first blood supply tube. , a second blood supply tube communicating with the concentrated red blood cell outflow port of the plasma separator, a first pressure detection means provided in the first blood supply tube between the blood supply means and the plasma separator, and a second pressure detection means. the second one provided in the blood vessel
pressure detection means, the difference between the first detection pressure detected by the first pressure detection means and the second detection pressure detected by the second pressure detection means, the predetermined first set pressure, and the a comparison means for comparing the first set pressure with a predetermined second set pressure higher than the first set pressure;
When it is detected that the difference between the detected pressure and the second detected pressure is lower than the first set pressure, the blood feeding means is stopped for a predetermined period of time, and then the blood feeding amount of the blood feeding means is reduced by a predetermined amount. It is characterized by comprising a blood flow rate control means for controlling the detected pressure between the first and second set pressures by repeating the operation of driving the blood means.

The present invention also provides a plasma separator having a blood inlet, a concentrated red blood cell outlet, and a plasma outlet, a first blood supply tube communicating with the plasma outlet, and a blood supply means provided in the first blood supply tube. , a second blood supply tube communicating with the concentrated red blood cell outflow port of the plasma separator, a first pressure detection means provided in the first blood supply tube between the blood supply means and the plasma separator, and a second pressure detection means. the second one provided in the blood vessel
the difference between the first detected pressure detected by the first pressure detecting means and the second detected pressure detected by the second pressure detecting hand, a predetermined first set pressure, and a comparison means for comparing the first set pressure with a predetermined second set pressure higher than the first set pressure;
When it is detected that the difference between the detected pressure and the second detected pressure is higher than the second set pressure, the blood feeding means is stopped for a predetermined period of time, and then the amount of blood fed by the blood feeding means is increased by a predetermined amount. It is characterized by comprising a blood flow rate control means for controlling the detected pressure between the first and second set pressures by repeating the operation of driving the blood means.

The present invention also provides a flow rate control method for a plasma separator that introduces blood from a donor using a blood feeding means, separates the blood into blood cell components and plasma components using a plasma separator, and collects the plasma components. The blood pressure sampled from the blood donor is detected at predetermined time intervals using a pressure detection means, and when the blood sample pressure falls below the first set pressure, the blood supply means is stopped for a predetermined period of time, and then the blood supply means is stopped. While repeating the control of operating with the flow rate reduced by a predetermined amount, when the blood sampling pressure rises above the second set pressure, the blood feeding means is stopped for a predetermined period of time, and then the flow rate of the blood feeding means is increased by a predetermined amount and operated. It is characterized by repeated control.

The present invention also provides a flow rate control method for a plasma separator, which separates the blood into blood cell components and plasma components and collects the plasma components by guiding blood from a blood donor to a plasma separator using a delivery means. , the pressure on the concentrated red blood cell outlet side of the plasma separator is detected at predetermined time intervals using a pressure detection means, and when the concentrated red blood cell outlet side pressure rises above a first set pressure, the blood feeding means is activated at a predetermined level. After stopping for a predetermined time, the flow rate of the blood feeding means is reduced by a predetermined amount and the operation control is repeated, and when the pressure on the concentrated red blood cell outlet side falls below the second set pressure, after the blood feeding means is stopped for a predetermined time. The method is characterized in that control is repeated in which the flow rate of the blood feeding means is increased by a predetermined amount and the operation is performed.

The present invention also provides a flow rate control method for a plasma separator that separates blood into blood cell components and plasma components and collects the plasma components by guiding blood from a donor to a plasma separator using a blood feeding means. The loss pressure represented by the difference between the blood inflow port side pressure and the concentrated red blood cell outflow port side pressure of the plasma separator is detected at predetermined intervals, and when the loss pressure rises above the first set pressure, the After the blood feeding means is stopped for a predetermined time, the flow rate of the blood feeding means is reduced by a predetermined amount and the operation is repeated. When the loss pressure is lower than the second set pressure, after the blood feeding means is stopped for a predetermined time. , is characterized by repeating control in which the flow rate of the blood feeding means is increased by a predetermined amount and the operation is performed.

Furthermore, the present invention provides a flow rate control method for a plasma separator, which separates blood introduced from a donor into a blood cell component and a plasma component by guiding it to a plasma separator, and collects the plasma component using a blood feeding means. The filtration differential pressure represented by the difference between the plasma outlet side pressure of the plasma separator and the concentrated red blood cell outlet side pressure after plasma separation is detected at predetermined time intervals, and the filtration differential pressure is set to the first setting. When the pressure drops below the second set pressure, the blood feeding means is stopped for a predetermined time, and the flow rate of the blood feeding means is reduced by a predetermined amount and the operation is repeated. When the filtration differential pressure rises above the second set pressure, The method is characterized in that after the blood feeding means is stopped for a predetermined period of time, the flow rate of the blood feeding means is increased by a predetermined amount and the operation is repeated.

[Embodiments] Next, preferred embodiments of the plasma separation device and its flow rate control method according to the present invention will be described in detail with reference to the accompanying drawings.

FIG. 1 is a schematic diagram of a plasma separation apparatus according to this embodiment. In the figure, reference numeral 10 indicates a plasma separator, and the plasma separator 10 has a reservoir 12 for storing blood B collected from a blood donor 11, and a plasma separator for separating plasma component P from the blood B. Basically, it consists of a filter 14, a plasma bag 16 for collecting the separated plasma component P, an anticoagulant bag 18 and a physiological saline bag 20 for adding an anticoagulant such as ACD to the blood at a predetermined ratio. It is composed of

Blood B drawn out by the action of a blood pump 26 from a blood collection means 24 such as a blood collection needle connected to an artery or vein of the blood donor 11 is stored in the reservoir 12 via a first clamp 28 . In this case, an anticoagulant such as ACD is drawn out from the anticoagulant bag 18 by the action of the ACD pump 30 and added to the blood B at a predetermined ratio.

The collected blood B passes through the bubble detector 34 and the first chamber 36 to the filter 1 by the action of the circulation pump 32.
The plasma component P is introduced into the hemolysis detector 4 through the action of the plasma pump 40 from one output passage of the filter 14.
2 and is stored in a plasma bag 16.

On the other hand, the other output passage of the filter 14 for deriving the blood cell component Q in the blood B communicates with the reservoir 12 via a second clamp 44 and also communicates with the reservoir 12 via a second chamber 46 and a third clamp 48. connected to the blood sampling means 24;
It is configured to return the blood cell component Q to the blood donor 11. Furthermore, the saline bag 20 is connected to the blood collection path between the blood pump 26 and the first clamp 28 via the fourth clamp 50, and before priming the blood B to the blood flow path of the plasma separation device 10, It acts to fill the physiological saline solution. Note that atmospheric release valves 52, 54, and 56 are provided at predetermined locations in the blood flow path. In this case, the atmosphere release valve 52 is opened at the time of final washing blood return, and
The atmosphere release valves 54, 56 are used during priming and are closed at other times.

A reference numeral 60 is provided at the front stage of the blood pump 26 to pump blood B.
62 shows a first pressure gauge for detecting the blood pressure of
shows a second pressure gauge connected to the second chamber 46 and detecting the blood cell outlet side pressure of the blood B separated in the filter 14. Further, reference numeral 64 is a third chamber connected to the first chamber 36 and configured to detect the pressure on the blood artificial side to the filter 14.
The reference numeral 66 indicates a fourth pressure gauge which is provided upstream of the plasma pump 40 and detects the plasma outlet side pressure of the filter 14, and the respective pressure gauges 60, 62, 64
and 66 are used to control the flow rate of each pump, which will be described later.

Note that the first chamber 36 prevents air bubbles from entering the filter 14, and the second chamber 46 prevents air bubbles from entering the filter 14, and the second chamber 46 prevents air bubbles from entering the filter 14.
The blood level in each chamber 36.46 is detected by a level detector 68.70. Further, the hemolysis detector 42 is installed to detect the presence or absence of a so-called hemolytic state in which the blood cell component Q is split due to the membrane pressure of the filter 14 or the pressure fluctuation of the circulation pump 32 and mixed into the plasma component P. be done.

The plasma separation apparatus 10 configured as described above is controlled by an operation control section 72 shown in FIG. That is, the detected pressures of the first to fourth pressure gauges 60, 62, 64 and 66 are amplified by amplifiers 7'4a to 74d, and then selected by a multiplexer 76 and sent to an A/D converter 78.
is converted into a digital value and introduced into the microcomputer 80. The detected pressure introduced into the microcomputer 80 is stored in a predetermined storage area of the RAM MB2 by the CPU 84 via the I10 interface 82.

The microcomputer 80 sets a predetermined set pressure and each pressure gauge 6 based on the control program set in the ROM 88.
The detected pressures of 0.62.64 and 66 are compared, and control signals are sent via the I10 interface 90 to increase or decrease the flow rates of the blood pump 26, circulation pump 32, and plasma pump 40 by predetermined amounts, respectively, as described later. and outputs to D/A converters 92a to 92c. In this case, the control signals converted into analog signals by the D/A converters 92a to 92C are sent to the motors 96a to 96C, which rotate the blood pump 26, the circulation pump 32, and the plasma pump 40, through the drive circuits 94a to 94C, respectively. Supplied.

The amount of rotation of the motors 96a to 96c is determined by the encoder 9.
Waveform shaping circuit 100a detected by 8a to 98C
100C and is fed back to the CPU 84 via the I10 interface 90.

The plasma separation device according to this embodiment is basically constructed as described above, and next, a method for controlling the blood flow rate in this device will be explained.

Prior to blood collection, the fourth clamp 50 is opened, and the blood flow path of the plasma separation device 10 is filled with physiological saline from the saline bag 20. Next, after the third clamp 48 and the fourth clamp 50 are closed and the first clamp 28 and the second clamp 44 are opened, blood collection is started.

In this case, blood B is drawn out from the donor 11 by the blood pump 26 via the blood collection means 24, and an anticoagulant such as ACD is drawn out from the anticoagulant bag 18 by the action of the ACD pump 30 at a predetermined ratio. B is added to Reservoir 1
It is stored in 2. On the other hand, blood B stored in the reservoir 12 is supplied to the filter 14 via the first chamber 36 by the circulation pump 32. Note that a portion of the blood B that has passed through the filter 14 is returned into the sachet 12. here,
As the filter 14, only the plasma component P is transferred to the plasma bag 16.
A type that can be passed through the side is used. The plasma component P separated by the filter 14 is stored in the plasma bag 16 via the hemolysis detector 42 by the action of the plasma pump 40.

On the other hand, when returning blood, the first clamp 28 and the second clamp 44
is closed and the third clamp 48 is opened, and furthermore, the blood pump 26 is stopped and only the circulation pump 32 and plasma pump 40 are operated. Therefore, the blood B containing a part of the concentrated blood cell component Q in the reservoir 12 is transferred to the second chamber which operates as a blood return chamber.
While the blood is returned to the donor 11 through the chamber 46,
Plasma component P is introduced into plasma bag 16 via filter 14 .

Therefore, as mentioned above, the pressure inside the blood flow path is measured by the pressure gauge 6.
0.62.64 and 66, amplified by amplifiers 74a to 74d, sequentially selected by multiplexer 76, and introduced into microcomputer 80 via A/D converter 78 (see FIG. 2). Microcomputer 80 transfers the detected pressure as a digital signal to CPU 84 via I10 interface 82. C
The P U 84 compares the detected pressure with a predetermined set pressure according to the control program in the ROM 88 and outputs a control signal obtained based on the comparison result to the I10 interface 90. Next, the control signals are supplied to predetermined D/A converters 92a to 92C and converted into analog signals, and then drive the corresponding motors 96a to 96C via drive circuits 94a to 94C. As a result, pump 26
．． 32 and 40 are rotated by a predetermined amount to control the pressure in the blood flow path and the blood flow rate. In addition, each pump 26.32
The rotation amounts of 40 and 40 are detected by encoders 98a to 98c, and fed back to the CPU 84 via the waveform shaping circuits 100a to 100c and the 10 interface 90. As a result, feedback control of each motor 96a to 96C is performed.

Next, each pump 26 using the operation control section 72 described above.
The flow rate controls 32 and 40 will be specifically explained.

First, the flow rate control of the blood pump 26 based on the detection of blood pressure by the pressure gauge 60 will be explained with reference to the time charts of FIGS. 3a and 3b.

Now, when the blood flow 1tQB of the blood pump 26 is controlled to a predetermined set value QB, . . . as shown in FIG. Alternatively, when the blood sampling pressure decreases due to a cause such as the tip of the blood sampling means 24 touching a blood vessel of the blood donor 11, the pressure detected by the pressure gauge 60 also changes. In this case, the blood pressure detected by the pressure gauge 60 is compared with the blood pressure control value (first set value) PVI in the CPU 84 constituting the microcomputer 80. The blood pressure is the blood pressure control value PV.
If the value falls below I, the microcomputer 80 immediately stops the operation of the blood pump 26 for a predetermined period of time, and then sends a control signal to the I10 interface 90 and D/A conversion in order to reduce the flow rate of blood B by a predetermined amount AVQI. The output signal is output to a motor 96a via circuits 92a to 92C and drive circuits 94a to 94C. This causes the blood pump 26 to rotate by a predetermined amount.

Next, at the flow rate (QB,, □-AVQI), AV
After T2 has elapsed, if the blood pressure detected by the pressure gauge 60 is still lower than the blood pressure control value PVI, the blood pump 26 is stopped again for the time AVT1, and then the flow rate of blood B is further lowered by a certain amount AVQI. Continue blood sampling.

If the blood sampling pressure decreases even if the flow rate of the blood pump 26 is lowered by AVQI and becomes below the sampling pressure lower limit value P Vffi, the CPU 84 issues an alarm via a drive means (not shown) for all pumps 26. 30. Stop 32 and 40. Furthermore, when the flow rate of the blood pump 26 reaches the lower limit by repeating the operation of lowering the flow rate of the blood pump 26 by AVQI, a similar alarm is issued and all the pumps 26, 30, 32 and 40 are stopped.

In addition, after once lowering the flow rate of the blood pump 26 in response to a decrease in the blood sampling pressure, when the blood sampling pressure detected by the pressure gauge 60 increases and exceeds the second set value pvr+pvw, the flow rate of the blood pump 25 decreases. is increased by a certain amount AVQ2. Then, after a certain period of time AVT2, when the blood pressure is greater than or equal to PVI+PVW, the flow rate of the blood pump 26 is further increased by a certain amount AVQ2. By repeating the above operation control, blood B can be supplied to the reservoir 12 at an optimal blood sampling pressure.

Here, it is preferable to initialize the flow rate of the blood pump 26 as shown in FIG. 4. That is, at the start of blood collection, the flow rate of the blood pump 26 is not immediately set to the set value QB□9, but is set to the initial value QB which is the average flow rate that can be adopted.
Start at o, and after time AVT3 elapses, a certain amount AVQ3
, and blood is finally collected at the set value QBffi, . This makes it possible to secure an optimal blood collection volume in a short period of time in accordance with the physiological conditions of the living body. In addition, if a drop in the blood sampling blood pressure occurs during the process of increasing the flow rate of the blood pump 26 from the initial value QB to the set value QB, H, the optimal blood sampling volume is ensured by performing the above-mentioned control. be done. In this case, blood pump 26
It goes without saying that when the flow rate of the anticoagulant is increased or decreased, it is preferable that the flow rate of the ACD pump 30 and the circulation pump 32 which add the anticoagulant are also increased or decreased at the same rate.

Next, the flow rate control of the circulation pump 32 will be explained with reference to the time charts shown in FIGS. 5a and 5b.

In FIG. 1, the pressure at the time of blood collection is monitored by the pressure gauge 62 as the filter outlet pressure PO, and the pressure at the time of blood return is monitored by the pressure gauge 62 as the returned blood pressure. Moreover, the population pressure PI of the filter 14 is monitored by the pressure gauge 64, and the filter loss pressure PD=PI-PO is obtained from these.

Now, when the flow rate of the circulation pump 32 is operating at the set value QC,..., if the filter outlet pressure PO becomes equal to or higher than the filter outlet pressure control value POI which is the first set value, or if the filter loss pressure PD When the filter loss pressure control value PDI, which is the first set value, is exceeded, the circulation pump 32 is immediately opened and stopped at AOT1 for a certain period of time, and then the pump flow rate is lowered by a certain amount AOQ1 and operated. Next, after a certain period of time AOT2, if the filter outlet pressure PO is still higher than the filter outlet pressure control value POI, or if the filter loss pressure PD is higher than the filter loss pressure control value PDI, the closed circulation pump 32 for a certain period of time AOT1 After stopping, the flow rate of blood B is lowered by a certain amount AOQ1 and operation is continued. If the flow rate of the circulation pump 32 is set to a certain amount AOQl
If the filter outlet pressure PO rises even if the filter pressure is lowered by 68%, or exceeds the filter output pressure upper limit PO□68, or if it exceeds the filter loss pressure upper limit P 26. Stop 30.32 and 40. Further, when the flow rate of the circulation pump 32 reaches the lower limit by repeating the operation of lowering the flow rate of the circulation pump 32 by the AOQI, a similar alarm is issued and all pumps 26, 30, 32 and 40 are stopped.

Note that after lowering the flow rate of the -H circulation pump 32 due to an increase in the filter outlet pressure PO, when the filter outlet pressure PO decreases and becomes equal to or less than the second set value (POIPOW), the flow rate of the circulation pump 32 is kept constant. Increase the amount by AOQ2. Similarly, after a certain period of time AOT2, when the filter outlet pressure PO is below the second set value (POI-PO'vV), the flow rate of the circulation pump 32 is further increased by a certain amount AOQ2. Also,
After lowering the flow rate of the -H circulation pump 32 due to an increase in the filter loss pressure PD, when the filter loss pressure PD decreases to below the second set value (PDI-PDW), the flow rate of the circulation pump 32 is reduced. Increase by a certain amount of ff1AOQ2. Furthermore, after a certain period of time AOT2, when the filter loss pressure PD is equal to or lower than the second set value (PD>PDW), the flow rate of the circulation pump 32 is increased again by a certain amount AOQ2. Here, P.O.
W and PDW indicate the amount of decrease in the filter outlet pressure control value POI and the filter loss pressure control value PDI.

Similarly, it will be easily understood that the flow rate of the plasma pump 40 can be controlled by reading each parameter in the explanation of the control of the blood pump 26 described above as follows. That is, the blood sampling pressure is read as the filtration differential pressure (the detected value of the pressure gauge 66 - the detected value of the pressure gauge 62), and the blood sampling pressure control value PVI is read as the filtration differential pressure control value Pfor. Furthermore, AVTI
is Af, T I, AVQl is Af, Ql, ΔVT2 is A
foT2 and PVffiln are read as PfO+sin, and the blood pump flow rate lower limit value is defined as the plasma pump flow rate lower limit value. Also, PVI + PV'vV is Pf, I ten PfoW,
AVQ2 is A f o Q 2, QBffi, , is Qf
All in all, blood pump 26 may be replaced by plasma pump 40.

Note that typical examples of each parameter in the in-flow control of each pump 26, 32 and 40 are as follows.

QB□ and QC,,,1 Qfo□X VI POI P[. I PDI 40 to 100 d/min 40 to 15 htl'/min 10 to 25 rnl/min 100 to Omm Hg 5 (1 to 250 mn+Hg 30 to OmmHg 50 to 200 mmHg P Vmih : -150 to -80 mm
HgP O,,: 150 ~ 300mmHgPro
,,,+h: 100-50mmHgP D,a,
: 150-300mmHgPVW, P
OW, PfoW, PDW: 5-50mmHgA
VTI, AOTI, AfoTl: 0-3 seconds AVQI, A
OQ 1°1~10m1/min AfoQl
: 0.5~5m/min AVT2
, AOT2, AfoT2: 1 to tO seconds AVQ2
, AOQ2: 1~10mf/min Afo
Q2: o, 5~5 mj
i! /min QBO: 30~60rnf! ,/min AVT3: 0.5-15 seconds Av
Q3: 5~15mI! /min [Effects of the Invention] According to the present invention, the following advantages can be obtained.

That is, in the present invention, when blood is drawn from a donor using a blood pump and the blood is guided to a plasma separator to separate the blood into blood cell components and plasma components and the plasma components are collected, the donor The blood pressure sampled from the blood pump is detected at predetermined time intervals using a pressure gauge, and the blood pump flow rate is repeatedly controlled step by step by comparing the sampled blood pressure with a set pressure. Therefore, even if the cause of variation in the blood sampling blood pressure is due to physiological conditions of the blood donor or mechanical causes such as when the tip of the blood sampling device touches a blood vessel, the flow rate of the blood pump can be adjusted to the same level. This method allows fine-grained and optimal control.

Further, in the present invention, the flow rate of the blood pump at the start of blood collection is set to an average flow rate at which blood can be collected, and the flow rate of the blood pump is controlled in stages by comparing the blood collection pressure and the set pressure at predetermined intervals. ing.

Therefore, control can be performed to maintain the maximum possible blood collection amount from the donor in a short time from the start of blood collection, and therefore, the blood collection time can be shortened.

Further, in the present invention, when blood drawn from a blood donor is guided to a plasma separator using a circulation pump to separate the blood into a blood cell component and a plasma component and the plasma component is collected, the plasma separator The outlet side pressure of the blood or the pressure difference between the artificial blood side and the outlet side of the blood in the plasma separator is detected every predetermined time using a pressure gauge, and the pressure or the pressure difference is compared with the set pressure. The flow rate of the pump is controlled repeatedly in stages.

Furthermore, in the present invention, when collecting the plasma components separated by the plasma separator using a plasma pump, a pressure gauge is used to measure the pressure difference between the blood outlet side pressure of the plasma separator and the plasma outlet side pressure. The flow rate of the plasma pump is repeatedly controlled step by step by detecting the pressure difference at predetermined intervals and comparing the pressure difference with a set pressure. Therefore, the flow rate of the circulation pump or the plasma pump can be optimally controlled in accordance with changes in the filtration capacity of the plasma separator, making it possible to collect plasma while making full use of the capacity of the plasma separator.

Although the present invention has been described above with reference to preferred embodiments, the present invention is not limited to these embodiments.
Of course, various improvements and changes in design are possible without departing from the gist of the present invention.

[Brief explanation of the drawing]

Fig. 1 is a schematic configuration diagram of a plasma separator according to the present invention, Fig. 2 is a block diagram of the configuration of the operation side control section of the plasma separator according to the present invention, and Fig. 3 is a schematic block diagram of the plasma separator according to the present invention. FIG. 4 is a time chart explaining the initial flow rate control of the blood pump in the plasma separation device according to the present invention; FIG. 5 is a time chart explaining the flow rate control of the blood pump in the plasma separation device according to the present invention. It is a time chart explaining flow control. 10...Plasma separation device 11...Blood donor 12
...'Jf-c14... Filter 16... Plasma bag 18... Anticoagulant bag 20... Physiological saline bag 26... Blood pump 28... Clamp 30... ACD Pump 32...
Circulation pump 34...Bubble detector 36...
Chamber 40...Plasma pump 42...
Hemolysis detector 44... Clamp 46... Chamber 48.50... Clamp 52.5
4.56...Atmospheric release valve 60.62.64.66
...Pressure gauge 68.70...Level detector 72...Operation control section 80...Microcomputer exposure

Claims (12)

[Claims] (1) A blood collection section, a plasma separator having a blood inflow port, a concentrated red blood cell outflow port, and a plasma outflow port, a blood supply tube that communicates the blood collection section and the blood inflow port of the plasma separator, and a plasma separator provided in the blood supply tube. a pressure detecting means provided in a blood feeding tube between the blood sampling section and the blood feeding means, a detected pressure detected by the pressure detecting means, a predetermined first setting pressure, and the first set pressure.
a comparison means for comparing a predetermined second set pressure higher than the set pressure; and a blood feeding means stopped for a predetermined period of time when the comparison means detects that the detected pressure is lower than the first set pressure. and a blood supply flow rate control means for controlling the detected pressure between the first and second set pressures by repeating the operation of reducing the blood supply volume of the blood supply means for a predetermined period of time and driving the blood supply means. Characteristic plasma separation device. (2) A blood sampling section, a plasma separator having a blood inflow port, a concentrated red blood cell outflow port, and a plasma outflow port, a blood supply tube that communicates the blood collection section and the blood inflow port of the plasma separator, and a plasma separator provided in the blood supply tube. a pressure detecting means provided in a blood feeding tube between the blood sampling section and the blood feeding means, a detected pressure detected by the pressure detecting means, a predetermined first setting pressure, and the first set pressure.
a comparison means for comparing a predetermined second set pressure higher than the set pressure; and a blood feeding means stopped for a predetermined period of time when the comparison means detects that the detected pressure is higher than the second set pressure. and a blood supply flow rate control means for controlling the detected pressure between the first and second set pressures by increasing the blood supply volume of the blood supply means by a predetermined amount and repeating the operation of driving the blood supply means. Characteristic plasma separation device. (3) a blood collection section, a plasma separator having a blood inflow port, a concentrated red blood cell outflow port, and a plasma outflow port; a blood supply tube that communicates the blood collection section with the blood inflow port of the plasma separator; a blood feeding means provided in the blood feeding means; a comparison means for comparing the detected flow rate detected by the flow rate detection means with a predetermined set flow rate; and a detected flow rate in the comparison result by the comparison means. blood supply flow rate control means for increasing the blood supply volume of the blood supply means when the detected flow rate is lower than the set flow rate, and controlling the blood supply volume of the blood supply means to decrease the blood supply volume of the blood supply means when the detected flow rate is higher than the set flow rate. A plasma separation device characterized by: (4) A plasma separator having a blood inlet, a concentrated red blood cell outlet, and a plasma outlet, a first blood supply tube communicating with the blood inlet of the plasma separator, and a blood supply provided in the first blood supply tube. a second blood supply tube communicating with the concentrated red blood cell outflow port of the plasma separator; a first pressure detection means provided in the first blood supply tube between the blood supply means and the plasma separator; a second pressure detection means provided in the blood supply tube; a second detected pressure detected by the second pressure detection means; a predetermined first set pressure; and a predetermined pressure lower than the first set pressure. or the difference between the first detected pressure detected by the first pressure detection means and the second detected pressure, a predetermined third set pressure, and the third setting. a comparison means for comparing a predetermined fourth set pressure that is lower than the pressure; and when the comparison means detects that the second detected pressure is higher than the first set pressure; If it is detected that the difference with the detected pressure is higher than a third set pressure, the blood feeding means is stopped for a predetermined period of time, and then the blood feeding amount of the blood feeding means is reduced by a predetermined amount and the blood feeding means is driven. A blood flow rate that controls the second detected pressure between the first and second set pressures by repeating the operation, or controls the difference between the first detected pressure and the second detected pressure between the third and fourth set pressures. A plasma separation device comprising a control means. (5) A plasma separator having a blood inlet, a concentrated red blood cell outlet, and a plasma outlet, a first blood supply tube communicating with the blood inlet of the plasma separator, and a blood supply provided in the first blood supply tube. a second blood supply tube communicating with the concentrated red blood cell outflow port of the plasma separator; a first pressure detection means provided in the first blood supply tube between the blood supply means and the plasma separator; a second pressure detection means provided in the blood supply tube; a second detected pressure detected by the second pressure detection means; a predetermined first set pressure; and a predetermined pressure lower than the first set pressure. or the difference between the first detected pressure detected by the first pressure detection means and the second detected pressure, a predetermined third set pressure, and the third setting. a comparison means for comparing a predetermined fourth set pressure lower than the pressure; and when the comparison means detects that the second detected pressure is lower than the second set pressure; If it is detected that the difference with the detected pressure is lower than a fourth set pressure, the blood feeding means is stopped for a predetermined period of time, and then the blood feeding amount of the blood feeding means is increased by a predetermined amount to drive the blood feeding means. A blood flow rate that controls the second detected pressure between the first and second set pressures by repeating the operation, or controls the difference between the first detected pressure and the second detected pressure between the third and fourth set pressures. A plasma separation device comprising a control means. (6) a plasma separator including a blood inlet, a concentrated red blood cell outlet, and a plasma outlet; a first blood supply tube communicating with the plasma outlet; and a blood supply means provided in the first blood supply tube; a second blood supply tube communicating with the concentrated red blood cell outflow port of the plasma separator; a first pressure detection means provided on the first blood supply tube between the blood feeding means and the plasma separator; The second pressure detection means provided, the difference between the first detection pressure detected by the first pressure detection means and the second detection pressure detected by the second pressure detection means, and the predetermined first pressure detection means. and a predetermined second set pressure that is higher than the first set pressure. If it is detected that the pressure is low, the blood feeding means is stopped for a predetermined period of time, and then the blood feeding amount of the blood feeding means is decreased by a predetermined amount and the operation of driving the blood feeding means is repeated. A blood plasma separation device comprising: a blood flow rate control means for controlling the blood flow between the second set pressures. (7) a plasma separator including a blood inlet, a concentrated red blood cell outlet, and a plasma outlet; a first blood supply tube communicating with the plasma outlet; and a blood supply means provided in the first blood supply tube; a second blood supply tube communicating with the concentrated red blood cell outflow port of the plasma separator; a first pressure detection means provided on the first blood supply tube between the blood feeding means and the plasma separator; The second pressure detection means provided, the difference between the first detection pressure detected by the first pressure detection means and the second detection pressure detected by the second pressure detection means, and the predetermined first pressure detection means. and a predetermined second set pressure that is higher than the first set pressure. If it is detected that the pressure is high, the blood feeding means is stopped for a predetermined period of time, and then the blood feeding amount of the blood feeding means is increased by a predetermined amount and the operation of driving the blood feeding means is repeated. A blood plasma separation device comprising: a blood flow rate control means for controlling the blood flow between the second set pressures. (8) A flow rate control method for a plasma separator that introduces blood from a donor using a blood feeding means, separates the blood into a blood cell component and a plasma component using a plasma separator, and collects the plasma component, the method comprising: The blood pressure collected from the blood donor is detected at predetermined time intervals using a pressure detection means, and when the blood collection pressure falls below a first set pressure, the blood supply means is stopped for a predetermined time, and then the flow rate of the blood supply means is adjusted. While repeating control to reduce the amount by a predetermined amount,
Flow rate control of a plasma separator, characterized in that when the blood sampling pressure rises above a second set pressure, the blood feeding means is stopped for a predetermined time, and then the flow rate of the blood feeding means is increased by a predetermined amount and the operation is repeated. Method. (9) A flow rate control method for a plasma separator according to claim 8, characterized in that the flow rate of the blood feeding means at the start of blood collection is set to an average flow rate at which blood can be collected. (10) A flow rate control method for a plasma separator, which separates the blood into a blood cell component and a plasma component and collects the plasma component by guiding blood from a blood donor to a plasma separator using a delivery means, the method comprising: The pressure on the concentrated red blood cell outlet side of the plasma separator is detected at predetermined time intervals using a pressure detection means, and when the concentrated red blood cell outlet side pressure rises above a first set pressure, the blood feeding means is stopped for a predetermined time. After that, the flow rate of the blood feeding means is reduced by a predetermined amount and the operation control is repeated, and when the pressure on the concentrated red blood cell outlet side falls below the second set pressure, the blood feeding means is stopped for a predetermined period of time, and then the blood feeding means is stopped. 1. A flow rate control method for a plasma separator, comprising repeating control in which the flow rate of a blood means is increased by a predetermined amount. (11) A method for controlling the flow rate of a plasma separator, which separates the blood into a blood cell component and a plasma component and collects the plasma component by guiding blood from a donor to a plasma separator using a blood feeding means, The loss pressure represented by the difference between the blood inflow port side pressure and the concentrated red blood cell outflow port side pressure of the plasma separator is detected at predetermined intervals, and when the loss pressure rises above the first set pressure, the blood feeding starts. After stopping the blood feeding means for a predetermined time, the flow rate of the blood feeding means is reduced by a predetermined amount and the operation is repeated. When the loss pressure falls below the second set pressure, after stopping the blood feeding means for a predetermined time, the blood feeding means is operated. 1. A flow rate control method for a plasma separator, comprising repeating control in which the flow rate of a blood means is increased by a predetermined amount. (12) A flow rate control method for a plasma separator, which separates blood introduced from a donor into a blood cell component and a plasma component by guiding it to a plasma separator, and collects the plasma component using a blood feeding means, the method comprising: The filtration differential pressure represented by the difference between the plasma outlet side pressure of the plasma separator and the concentrated red blood cell outlet side pressure after plasma separation is detected at predetermined time intervals, and the filtration differential pressure is lower than the first set pressure. When the blood feeding means is stopped for a predetermined period of time, the flow rate of the blood feeding means is reduced by a predetermined amount and the operation is repeated. When the filtration differential pressure rises above a second set pressure,
A flow rate control method for a plasma separator, comprising repeating control in which the blood feeding means is stopped for a predetermined period of time, and then the flow rate of the blood feeding means is increased by a predetermined amount.