JP5641417B2 - Apheresis equipment - Google Patents

Description

  The present invention relates to an apheresis device. More specifically, the present invention relates to improving the efficiency of each apheresis cycle and reducing the amount of anticoagulant used by using a novel disposable system for apheresis (disposal pull).

  Apheresis transforms whole blood into its various blood components: high density components such as red blood cells, at least one intermediate density component such as white blood cells and platelets such as lymphocytes and granulocytes, and low density components such as plasma. This is a method for separating and collecting a desired blood component. There are various methods for performing apheresis. Among them, a prominent one is an intermittent blood flow method in which whole blood is intermittently processed using centrifugation.

  Intermittent blood flow apheresis generally begins with a so-called “draw” step in which whole blood is collected from a donor, collected in a centrifuge, and separated into high density, intermediate density and low density components. After dispensing the components, it ends with a so-called “return” step that returns the blood components remaining in the disposable system to the donor. Fluid exchanges between the donor and the device during apheresis occur through a single path, such as a blood collection needle. As described in Patent Document 1, this is less burdened by the donor's restraint and can significantly reduce the processing time than the previous method.

  Until now, apheresis has been improved by various methods, and as described in Patent Document 2, low-density components separated out of the centrifuge are recirculated to the centrifuge for a short period of time. As described in the so-called “dwell” step, Patent Document 3, etc., low density components are recirculated in the centrifuge at a surge flow rate, that is, a flow rate that increases with time, and platelets and the like are given priority from intermediate density components. There is a so-called “surge” step, etc., to expedite. At present, apheresis is performed so that a predetermined blood component is collected by repeating one cycle composed of these steps several times.

  In addition, the draw step has been improved. As described in Patent Document 4, the plasma flow rate and the centrifugal rotation speed that pass through the centrifuge during the draw step are selected according to the donor, and per cycle. It has been proposed to control the whole blood throughput so as to be optimal for each individual donor. Such optimization of the cycle also leads to a reduction in processing time. However, the time required for one cycle is about 15 minutes on average, and considering that this is repeated a plurality of times, it is desirable to efficiently perform each cycle in a shorter time.

Japanese Patent Publication No. 1-16505 Japanese Patent No. 2776988 U.S. Pat. No. 4,416,654 Japanese Patent No. 319638

  FIG. 10 is a view similar to FIG. 1A of Patent Document 2, and includes a centrifuge bowl 1, a tube 3 extending between the blood donor and the inlet PT 1 of the bowl 1 via the venous needle 2, and an outlet PT 2 of the bowl 1. It is connected to a tube 5 extending to the plasma bag 4, a tube 6 extending from the bag 4 and connected to the tube 3, peristaltic pumps P 1 and P 2 respectively disposed in the tubes 3 and 6, and a tube 7 branched from the tube 5. 1 shows a typical apheresis apparatus including a platelet bag 8 and a pump P3 for introducing an anticoagulant from the bag 9 to the tube 3 through the tube 10. V1 to V6 are valves, F1 and F2 are filters, D1 to D3 are air detectors, and M1 and M2 are pressure monitors.

  After priming the tube in the initial operation, the venous needle 2 is inserted into the donor and the draw is started, the anticoagulated whole blood is separated in the bowl 1 and the plasma is first collected in the bag 4 and then Platelets are collected in the bag 8 through a dwell or surge. In some cases, further leukocytes are collected from the tube 11 into the leukocyte bag 12. During the draw, the whole blood entering the bowl 1 can be diluted with the plasma from the bag 4 or with physiological saline from the bag 13 or the like. The density of the liquid leaving the bowl 1 is detected by the line sensor 14, and each cycle is controlled accordingly.

  After the platelets and / or white blood cells are collected, the device begins to return. That is, the rotation of the bowl 1 is stopped and the high-density blood component remaining in the bowl 1 is returned to the blood donor by rotating the pump P1 in the reverse direction. The pump P2 is also operated to dilute the high-density blood components returned from the bowl 1 with plasma from the bag 4 or possibly liquid from the bag 13. The return is terminated when the remaining blood components in the bowl have been returned to the donor, and the venous needle 2 can be removed from the donor once the required number of cycles has been completed.

  Although the above process is sophisticated and allows platelets to be sorted with high efficiency, it is desirable to further reduce the time required for the cycle. For example, there is a time waiting for the rotation of the centrifuge bowl 1 to stop between the surge and the return, but this is a useless period from the viewpoint of manufacturing efficiency, and causes an increase in processing time. An object of the present invention is to solve such problems.

  In the blood treatment such as apheresis, the use of an anticoagulant is indispensable, and typically a mixture of citric acid and sodium citrate is used. These are not harmful, but since they may cause citric acid poisoning when returned to the human body, it is desirable to use them as little as possible. Another object of the present invention is to achieve a reduction in the amount of anticoagulant used in conjunction with the shortening of the treatment time as described above.

  The apheresis device of the present invention includes a collecting means such as a venous needle that collects whole blood from a donor, and a centrifugation means that has an inlet port and an outlet port and separates the collected whole blood into a plurality of blood components. A first passage extending between the collection means and the inlet port, a first pump disposed in the first passage, and detection for detecting a selected blood component in the fluid flowing out of the outlet port Means, a second passage extending between the outlet port and the first container, a third passage extending between the first container and the collecting means, and a second pump disposed in the third passage And a fourth passage extending between a portion of the third passage between the second pump and the first container and a portion of the first passage between the collecting means and the first pump; And control means. The first to fourth passages are opened or closed by a conduction control means including a valve such as a pinch valve, and thus can be selectively conducted. The detection means can include, for example, the line sensor described above with reference to Patent Document 2, an optical system for monitoring the separation state in the bowl, and the like. The control means is a microcomputer connected to the centrifuge means, the detection means, and the conduction control means for controlling the selective conduction of the passage, respectively, according to a well-known protocol for fractionating a required blood component. Control the operation of each means. This microcomputer may be appropriately programmed in advance so as to perform operations according to these protocols, and may be configured so that an appropriate program can be loaded according to circumstances. It is convenient to store the program in a card-type ROM and use it in an apheresis device together with a required disposable circuit.

  This type of apheresis device is usually a disposable circuit (disposable) in which a flexible plastic bag (container) is connected to a centrifuge bowl via a plastic tube (passage), a centrifuge, a valve, a micro It is configured by a combination with a blood processing apparatus composed of hardware such as a computer, and both function together when used. For example, a draw that collects whole blood from a donor involves a tube connected to a venous needle and bowl and a blood pump. In this case, the venous needle, the tube, and the bowl are part of the disposable, and the blood pump is part of the blood processing apparatus, and includes a non-contact type pump such as a peristaltic pump. The valve that controls the continuity of the tube is on the hardware side. The centrifuge bowl is such as the standard Latham bowl described in US Pat. No. 3,145,713.

  According to the invention, the control means operates the apheresis device according to the required protocol. This includes, for example, platelet and plasma collection (PLP) protocol, platelet poor plasma collection (PPP) protocol, etc. In any case, the control means is an apheresis device, and (1) whole blood is collected from a donor by the collection means. Then, the first pump sends the blood to the centrifugal separation means via the first passage and separates it into a plurality of blood components. (2) Plasma that is a low density component is passed through the second passage through the first passage. Control to perform the action of collecting in the container. Characteristic for the present invention is that the third passage extends between the first container and the collecting means, and the fourth passage is a portion of the third passage between the second pump and the first container. , Having a configuration extending between the sampling means and the portion of the first passage between the first pump, but by using this configuration, (3) the low density component is removed from the first container. (4) The high-density component is sent from the centrifugal separation means to the blood donor via the first passage, the fourth passage, the third passage, and the collection means. It is possible to control to perform the returning operation.

  According to the present invention, the collection means includes a venous needle and a branch connector, which is preferably connected to the first passage and the third passage. According to this, the low density component from the first container is returned to the vicinity of the venous needle. A sixth passage extending from the third container can be connected to the branch connector. An anticoagulant is accommodated in the third container, and the whole blood of the blood donor flowing in from the venous needle is anticoagulated by a third pump disposed in the sixth passage.

  The operation (3) can be performed at the time of returning blood, that is, at the time of returning the blood component remaining in the centrifugal separator to the blood donor. In this case, since the third passage extends between the first container and the collecting means, the return of the low density component by rotating the second pump can be started before the centrifuge means is stopped. . This leads to a reduction in the time required for the cycle. Thereafter, the operation (4) is started after the centrifuge unit is stopped, and the red blood cells, which are high-density blood components remaining in the centrifuge unit, are superposed on the operation (3), and are diluted with the low-density component to provide blood. It is returned to the person.

  The apheresis device according to the present invention, for example, when operating according to the platelet and plasma collection (PLP) protocol, branches from the second passage and extends into the fifth passage, which is selectively conductive, and the fifth passage. In this case, the control means causes the apheresis device to pass the intermediate density component, particularly platelets flowing out from the centrifugal separation means after the operation of (2), to the second container. It can be controlled to collect in a container. Such control preferably involves the surge described in Patent Document 3 and the dwell described in Patent Document 2. For example, in the case of a surge, when collecting the intermediate density component, the low density component is collected from the first container through the third passage, the fourth passage, and the first passage to the centrifuge by the first pump. And the medium density component is supplied at an acceleration flow rate sufficient to drive out the centrifugal separation means. In addition, when performing dwell, prior to the surge, the low-density component is transferred from the first container to the third passage, the fourth passage, the first passage, the centrifuge, and the second pump by the first pump. It is circulated through the passage again to the first container. In this case, the intermediate density component does not exit the centrifuge, but the separation between blood components of close density such as platelets and leukocytes is improved.

  According to the present invention, the control means can perform the operation (3) separately during the operations (1) and (2). In this case, the low density component is supplied from the first container to the centrifugal separation means via the third passage and the first passage, and is sent to the centrifugal separation means via the first passage by the first pump. Dilute the whole blood of the donor. This is a technique called critical flow, and is always performed in order to supply a certain amount of diluted whole blood to the centrifuge. In the present invention, the third passage is in the vicinity of the venous needle. Therefore, there is an advantage that the amount of the anticoagulant used may be smaller than that in the past. The cycle is then repeated as many times as desired.

  As described above, citric acid and sodium citrate are often used as anticoagulants, and these are returned to the donor along with plasma or red blood cells when returning blood. These are not harmful, but may cause citric acid poisoning in some cases, such as blood donors with low body weight or low hematocrit, and it is desirable that the amount be small. The present invention can meet such a demand.

  Furthermore, according to the present invention, the speed of the pump and the flow of the low density component during the critical flow are devised to replace the dwell function or while the dwell function is being performed, that is, the centrifugal separation means is While rotating at high speed, it is possible to return blood of low density components.

  According to the present invention, since the return operation can be started in advance before the centrifuge is stopped, the time required for the apheresis cycle can be shortened. In addition, the amount of anticoagulant used can be reduced during the critical flow, which is desirable for the final blood component preparation and can provide a safer and higher quality preparation. In addition, the apheresis device of the present invention partially changes the conventional disposable circuit and requires minimal hardware changes, so that the additional cost required for improvement can be reduced and conventional methods such as dwell and surge can be used. The same automated operation can be easily realized.

It is the schematic which shows the priming operation | movement in the preferable Example of the apparatus used for this invention. It is the schematic which shows the priming operation | movement of the return line in the initial stage of a draw in the preferable Example of the apparatus used for this invention. It is the schematic which shows operation | movement of the draw step in the preferable Example of the apparatus used for this invention. It is the schematic which shows the priming operation | movement of a surge line in the preferable Example of the apparatus used for this invention. It is the schematic which shows operation | movement of a critical flow in the preferable Example of the apparatus used for this invention. It is the schematic which shows the operation | movement of a dwell step and a surge step in the preferable Example of the apparatus used for this invention. It is the schematic which shows the operation | movement in the return step during centrifugation bowl rotation in the preferable Example of the apparatus used for this invention. It is the schematic which shows the operation | movement in the return step after a centrifuge bowl stop in the preferable Example of the apparatus used for this invention. It is a flowchart which shows an example of the algorithm used for determination of the quantity of an anticoagulant. 1 is a schematic diagram of an apheresis device according to the prior art.

  Referring to FIGS. 1-8, there is shown an overview of an apheresis device according to one embodiment of the present invention, particularly suitable for operating according to a platelet and plasma collection (PLP) protocol. The collection means for collecting the whole blood from the blood donor includes, for example, a venous needle 102 and a branch tube 116 following the vein needle 102, and the tube 103 extends between the branch tube 116 and the inlet port PT 1 of the centrifuge bowl 101. A tube 105 extends from the outlet port PT2 of the bowl 101 and is connected to a plasma / air bag 104 suspended on a weighing scale. A tube 106 extends from the bag 104 to a branch tube 116. Peristaltic pumps P1 and P2 are arranged in the tube 103 and the tube 106, respectively. A tube 107 branches off from the tube 105 and is connected to a platelet bag 108. The anticoagulant is supplied from the bag 109 displayed as ACD to the branch tube 116 through the tube 110 by the peristaltic pump P3. Further, from the tube 106, a tube 115 branches from a portion between the bag 104 and the pump P2, and is connected to the tube 103 between the branch tube 116 and the pump P1. As indicated by the dotted line, a tube 111 and a white blood cell bag 112 may be provided for collecting white blood cells, and a bag containing a liquid such as physiological saline for replacing plasma partially or entirely. 113 may be provided and connected to the tube 106. V1 to V7 are valves provided corresponding to the tubes, and selectively open or close fluid conduction through the associated tubes. F1 is a blood filter, F2 is a sterilization filter, D1 to D4 are air detectors, and M1 to M3 are blood donor and system pressure monitors. A microcomputer not shown is generated by line sensor 114, bowl optics 117, donor pressure monitor (DPM) M1 and M3, system pressure monitor (SPM) M2, and air detectors D1-D4 according to the protocol applied. In response to the signal, the pumps P1-P3 and valves V1-V7 are operated to control the direction and duration of the flow through the apheresis device. That is, the air detectors D1-D4 detect the presence or absence of a liquid. The pressure monitors M1-M3 monitor the pressure level in the apheresis device. The line sensor 114 detects the density of the fluid passing through the tube 105 and detects the presence of blood components passing through the line sensor 114 from the outlet port PT2 of the bowl 101. The bowl optical system 117 also monitors the separation status of the blood components in the bowl 101 and the position of the separated blood components in the bowl 101.

  In the initial operation shown in FIG. 1, pumps P2 and P3 are energized to prime tube 106 of the apheresis device partially with anticoagulant from bag 109 to blood filter F1. The anticoagulant passes through the sterilization filter F2 and the branch tube 116 and reaches the blood filter F1. During the priming operation, valve V1 is closed and valve V5 is open, and sterile air expelled from tube 106 by the anticoagulant enters bag 104.

  Next, the venous needle 102 is inserted into the blood donor and the draw step is started. In the first cycle, the return line is first primed as shown in FIG. During priming, valve V1 remains closed and valve V5 is also closed. The valve V7 is opened, the pumps P1, P2 and P3 are energized, and the whole blood of the blood donor mixed with the anticoagulant in the branch tube 116 and anticoagulated passes through the tubes 106 and 115, and passes through the tube 103. To reach the air detector D2. Air detector D2 detects the presence of this fluid and priming is terminated. In this case, the sterile air expelled from the bowl 101 enters the bag 104 from the tube 105 via the open valve V2.

  Next, as shown in FIG. 3, the whole blood collected from the blood donor via the venous needle 102 and anticoagulated in the branch tube 116 is centrifuged by the pump P1 from the inlet port PT1 via the tube 103 and the centrifuge bowl 101. To be supplied. Whole blood is collected from the donor at a flow rate of, for example, about 60 to 80 mL / min and mixed with the anticoagulant at a ratio of about 10: 1. As described above, the operation of each pump, valve, etc. in the apheresis device is performed according to a desired protocol under the control of a microcomputer (not shown). Valves V1 and V2 are opened, the remaining valves are closed, and pumps P1 and P3 are energized. When the bowl 101 is rotated, the anticoagulated whole blood introduced to the bottom of the bowl is separated into different components such as red blood cells, white blood cells, platelets and plasma by centrifugal force according to the density of the components. . The number of rotations of the bowl can be selected from a range of, for example, 4000 to 6500 rpm, and is typically 5400 rpm, for example. Within the bowl 101, blood components form concentric layers from the outside to the inside, in order of increasing density. That is, the red blood cell layer is pushed to the outermost side, and the plasma layer is present near the center. Between them, a buffy coat layer composed of an inner layer of platelets, a transition layer of platelets and leukocytes, and an outer layer of leukocytes is formed. The plasma layer is the component closest to the outlet port PT2, and when anticoagulated whole blood continues to be supplied to the centrifuge bowl 101 through the inlet port PT1, it was first spilled out through the outlet port PT2. Plasma is collected in the bag 104 via the tube 105, the line sensor 114, and the valve V2.

  FIG. 4 shows surge line priming performed during the draw step. Valve V1 is closed and valves V2, V5 and V7 are opened. The remaining valves are closed, the pump P2 is stopped, and the anticoagulated plasma is transferred from the outlet port PT2 of the bowl 101 to the inlet port PT1 through the tube 105, the bag 104, the tube 106, the tube 115, and the tube 103. Circulated through. This priming is performed only in the first cycle.

  FIG. 5 illustrates the application of the so-called critical flow technique that is conventionally performed to facilitate the collection of whole blood during the draw cycle and to improve separation. The plasma once separated and collected in the bag 104 is circulated into the bowl 101 at a constant flow rate of, for example, about 20 to 30 mL / min to improve the separation of blood components. In this case, as shown in FIG. 5, the apheresis device is controlled so that the valves V1, V2, and V5 are opened and the rest are closed, and the pumps P1 to P3 are all energized, but the pump P2 The direction of rotation is opposite to that described with reference to FIGS. As described above with reference to FIG. 10, the critical flow is also performed conventionally, but the plasma containing the anticoagulant is connected from the plasma bag 4 to the tube 3 between the pump P1 and the inlet port PT1 of the bowl 1. ing. On the other hand, as seen in the present embodiment, the tube 106 from the bag 104 is connected to the tube 103 via the branch tube 116. Therefore, the amount of anticoagulant supplied from the bag 109 can be reduced accordingly.

  Collection of whole blood in the draw step is performed until it is detected that the volume of blood components separated in the bowl 101, typically the volume of the red blood cell layer, has reached a predetermined amount. The detection can be performed by monitoring the radius of the region occupied by the blood component separated inside the bowl 101 by the bowl optical system 117 and determining that this radius has reached a specific value. Control means (not shown) such as a microcomputer starts a dwell step and a surge step as shown in FIG. 6 when the bowl optical system 117 detects the buffy coat at a specific position. That is, first in the dwell step, the valve V1 is closed, the valves V2, V5 and V7 are opened, the remaining valves are closed, and the pump P2 is stopped in the same manner as described in FIG. As described above, the dwell is a technique described in Patent Document 2, and a low density component, that is, plasma is substantially constant into the bowl 101 by the pump P1, and a flow rate larger than the collected flow rate of whole blood for a short period of time. (E.g., about 100 mL / min for about 20-30 seconds). This dilutes the buffy coat with plasma in the centrifuge bowl and improves the separation of platelets and leukocytes. However, unlike surge operation, the separated platelets do not flow out of the centrifuge bowl.

  In another aspect, the critical flow of FIG. 5 can be modified to perform a function similar to a dwell. In this case, the pump P3 is stopped to stop the flow of the anticoagulant, and the pump P1 and the pump P2 are rotated at the same speed. Whole blood from the donor does not flow in, but plasma flows from the bag 104 through the valve V5 to the tube 106 and the branch tube 116 to the tube 103, and passes through the bowl 101 from the inlet port PT1 through the valve V1. From the outlet port PT2, it is circulated through the tube 105 to the bag 104.

  Further, when performing such a modified critical flow, the pump P2 is rotated at a speed higher than the speed of the pump P1, so that the plasma is returned to the donor while the bowl 101 is rotating at a constant speed. You can also blood. In this case, the whole blood from the blood donor does not flow in the same manner as described above, and the plasma flows from the bag 104 to the tube 106 and the branch tube 116 via the valve V5. A part of the plasma is returned to the blood donor according to the speed difference of the pump P2. The remaining plasma flows from the branch tube 116 to the tube 103, passes through the bowl 101 from the inlet port PT1 through the valve V1, and is circulated from the outlet port PT2 to the bag 104 through the tube 105, and has the same function as the dwell. Is fulfilled. Thus, the time required for blood return can be further shortened by returning the blood plasma in advance even during the rotation of the bowl.

  When the surge operation is started as shown in FIG. 6, the pump P <b> 1 supplies plasma from the bag 104 with an acceleration flow rate sufficient to cause the platelets to flow out of the bowl 101. The surge begins, for example, at about 100 mL / min, and the speed of pump P1 is increased, for example, in increments of 5-10 mL / min, and the plasma in bag 104 is transferred to tubes 106, 115 and until a platelet surge rate of about 200-250 mL / min is reached. It is again supplied from the inlet port PT1 to the bowl 101 via 103. This platelet surge rate is a rate at which platelets can exit the bowl 101 but red blood cells or white blood cells cannot. Plasma exiting the outlet port PT2 of the bowl 101 becomes clouded with platelets, and this cloudiness is detected by the line sensor 114. The line sensor 114 includes, for example, an LED that emits light across the fluid passing through the tube 105 and a photoelectric detector that receives light after passing through the components. The amount of light received by the photoelectric detector is correlated with the concentration of blood components passing through the tube. Valve V2 is closed, valve V3 is opened, and platelets are collected in bag 108.

  After platelets are collected, the apheresis device begins a return step. FIG. 7 shows the return of the plasma performed until the rotation of the bowl 101 is stopped. Such a return during the rotation of the bowl is not possible with a conventional blood processing circuit. Valves V2 and V5 are opened, the remaining valves are closed, and a portion of the plasma from the bag 104 is returned from the branch tube 116 through the venous needle 102 via the tube 106 to the donor. Next, as shown in FIG. 8, when the rotation of the bowl 101 is stopped, the high-density blood component remaining in the bowl 101 is sucked out of the bowl 101 by opening the valve V7 and rotating the pump P1 in the reverse direction. Together with the flow of the low density component through 106, it is diluted and returned from the branch tube 116 through the venous needle 102 to the donor. This speeds up the return time. The return step ends when the remaining blood components in the bowl have been returned to the donor.

  This cycle of draw, surge and return is performed many times depending on the amount of platelets required. During the draw, especially if circulating plasma has not yet been obtained in the first cycle, the anticoagulated whole blood entering the bowl 101 should be diluted with a solution such as physiological saline from the bag 113. You can also. If necessary, white blood cells that flow out following platelets during a surge can be collected in the bag 112 using the tube 111 and the valve V4.

When the effect of reducing the amount of the anticoagulant according to the present invention is indicated by a numerical value, the fractional distillation ratio of the anticoagulant in the plasma preparation is calculated by the following formula.
Fraction ratio = 1 / {(R-1) × (1-Hct) +1}
R: anticoagulant mixing ratio Hct: donor hematocrit, decimal display (example 45% = 0.45)
Therefore, the amount of the anticoagulant in the plasma preparation can be calculated by the amount of plasma preparation × fractionation ratio. For example, the donor hematocrit is 45% = 0.45, and the anticoagulant mixing ratio is 10. When the pump speed is P1 = 60 ml / min in FIG. 10, P3 = 6 ml / min, and 6 ml of anticoagulant is added to 54 ml of whole blood from the donor every minute. From the above fractional ratio equation, the fractional fraction of the anticoagulant in the plasma product is:
1 / {(10−1) × (1−0.45) +1} = 1 / 5.95 = 0.168.

  Here, as shown in FIG. 5, when the case where the plasma in the plasma bag 104 is returned from the branch tube 116 to the donor through the tube 106 is considered, when the speed of the pump P2 is 10 ml / min, 10 ml of plasma is obtained. Inside, 10 ml × 0.168 = 1.68 ml of anticoagulant is contained. In the case of the conventional method, 6 ml of anticoagulant is always necessary. However, according to this method, (6-1.68) = 4.32 ml is sufficient, and a reduction of 28% is possible. The ratio of the whole blood amount to the anticoagulant amount is 54 ml: 4.32 ml = 12.5: 1, and the anticoagulant mixing ratio is 13.5.

  FIG. 9 is a flowchart illustrating an algorithm used to determine the amount of anticoagulant in one embodiment of the present invention. Such an algorithm is realized in the form of a program, and is executed in a microcomputer constituting the control means of the apparatus of the present invention. For example, this program can be stored in a card-type ROM together with a protocol program for executing apheresis, or can be selectively stored in a memory such as a ROM or RAM of the apparatus. You can also.

  According to the exemplary program of FIG. 9, after starting a draw according to the protocol used, it is detected based on a signal from a scale, for example, whether or not there is a predetermined amount of plasma in the bag 104. Next, the anticoagulant mixing ratio and donor hematocrit value, the current pump P1 and pump P3 speeds, and the critical flow (CF) speed by the pump P2, which are set in advance by inputting into the apparatus, are obtained. The fractional ratio is calculated according to the formula. The microcomputer determines the speeds of the pumps P2 and P3 based on the fraction ratio thus calculated, and changes the speed of the motor that drives these pumps. The draw step is performed with the critical flow at the changed pump speed, and as described above, the bowl optical system 117 detects that the volume of the red blood cell layer separated in the bowl 101 has reached a predetermined amount, for example. Will continue until.

101 Centrifugal bowl 102 Intravenous needle 103, 105, 106, 107, 110, 111, 115 Tube 104, 108, 109, 112, 113 Bag 114 Line sensor 116 Branch tube 117 Bowl optical system P1, P2, P3 Pump V1, V2 , V3, V4, V5, V6, V7 Valve M1, M2, M3 Pressure monitor D1, D2, D3, D4 Air detector F1, F2 Filter PT1 Inlet port PT2 Outlet port

Claims (15)

A collection means for collecting whole blood from a donor,
A centrifuge having an inlet port and an outlet port, and separating the collected whole blood into a plurality of blood components;
A first container;
A first passage extending between the sampling means and the inlet port and selectively conductive;
A first pump disposed in the first passage;
Detection means for detecting selected blood components in the fluid flowing out of the outlet port;
A second passage extending between the outlet port and the first container and selectively conductive;
A third passage extending between the first container and the collecting means and selectively conductive;
A second pump disposed in the third passage;
Extending between a portion of the third passage between the second pump and the first container and a portion of the first passage between the collection means and the first pump; A fourth passage selectively conductive;
Connected to the centrifuge means, the detecting means, and the conduction control means for controlling the selective conduction of the first passage, the second passage, the third passage, and the fourth passage, respectively. a apheresis apparatus that have a and the control means,
The control means controls the apheresis device,
(1) Whole blood is collected from a donor by the collection means, and sent to the centrifugal separation means through the first passage by the first pump to be separated into a plurality of blood components;
(2) collecting low density components in the first container via the second passage;
(3) flowing the low density component from the first container through the third passage toward the collecting means;
(4) controlling to return the high-density component from the centrifuge means to the blood donor via the first passage, the fourth passage, the third passage, and the collection means; Apheresis device . The apheresis device according to claim 1 , wherein the operation (3) is started before the centrifuge unit is stopped, and the low-density component is returned to the blood donor via the collection unit. The apheresis device according to claim 1 or 2 , wherein the operation (4) is started after the centrifuge unit is stopped and is superimposed on the operation (3). A fifth passage that branches off from the second passage and is selectively conductive; and a second container connected to the fifth passage;
Said control means said apheresis apparatus, wherein the controls to collect intermediate density component into the second container flows from said centrifugal separation means after the operation of (2), to any one of claims 1 to 3 The apheresis device described. Upon collection of the intermediate density component, the low density component is centrifuged by the first pump from the first container through the third passage, the fourth passage, and the first passage. 5. The apheresis device of claim 4 , wherein the apheresis device is supplied to a means at an accelerated flow rate sufficient to drive out the intermediate density component from the centrifuge means. Prior to the collection of the intermediate density component, the low density component is transferred from the first container to the third passage, the fourth passage, the first passage, and the centrifuge by the first pump. And the apheresis device according to claim 4 , wherein the apheresis device is circulated to the first container through the second passage. The operation of (3) by the control means is separately performed during the operations of (1) and (2), and the low density component is removed from the first container and the third passage by the second pump. Control is performed to dilute the donor's whole blood that is supplied to the centrifuge means through the first passage and sent to the centrifuge means through the first passage by the first pump. The apheresis device according to any one of claims 1 to 6 , wherein: The apheresis device according to claim 7 , wherein the first pump and the second pump are rotated at the same speed. The second pump is rotated at a faster speed than the first pump, the low density component during rotation of the centrifugal separation means is returned to the donor through said collecting means, according to claim 7 Apheresis device. The apheresis device according to any one of claims 1 to 9 , wherein the conduction control means is a valve disposed in each of the first passage to the fifth passage. The apheresis device according to any one of claims 1 to 10 , wherein the collection unit includes a venous needle and a branch connector, and the branch connector is connected to the first passage and the third passage. A third container for containing an anticoagulant, a sixth passage extending between the first passage and the third container, connected to the branch connector, and disposed in the sixth passage; The apheresis device according to claim 11 , further comprising a third pump. The control means obtains a fraction ratio of the anticoagulant in the low density component collected in the first container based on the set anticoagulant mixing ratio and the hematocrit value of whole blood, and this fraction ratio 13. The apheresis device according to claim 12 , which is dependent on claim 7 , wherein the speeds of the second pump and the third pump are controlled based on the control. The apheresis device according to claim 1, wherein the low density component is plasma and the high density component is red blood cells. 15. The apheresis device according to any one of claims 4 and 14 depending on claim 4 , wherein the intermediate density component is platelets.

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