JP4540949B2 - Apheresis equipment - Google Patents

Description

  The present invention relates to an apheresis device. More specifically, the present invention relates to increasing the production efficiency of a blood product in an apheresis device by performing a predetermined amount of additional blood collection after collecting an intermediate density component.

  As one of the mainstream methods of apheresis, there is a method adopted in the apparatus of the present applicant, Hemonetics. This involves collecting whole blood from a donor and concentrically separating it into high density components (red blood cells), intermediate density components (mainly platelets and white blood cells), and low density components (plasma) in a centrifuge. The main components are a so-called “draw” step and a so-called “return” step in which the blood components remaining in the centrifuge are returned to the blood donor after the required blood components have been collected. Until now, apheresis has been improved by various methods. Among them, as described in Patent Document 1, low-density components collected outside the centrifuge are recirculated to the centrifuge for a short period of time. As described in the so-called “dwell” technology and Patent Document 2, etc., low density components are recirculated into the centrifuge at a surge flow rate, that is, a flow rate that increases with time, and platelets and the like are removed from the intermediate density components. There are so-called “surge” technologies that preferentially flow out. Typically, apheresis collects a predetermined blood component by repeating one cycle composed of a combination of processes such as draw, dwell, surge, and return several times.

As a typical centrifuge used in apheresis, a Latham bowl is well known. This is described in, for example, Patent Document 3, and has an inlet port and an outlet port, and has a separation space for separating collected whole blood into components. In the blood component collection method using a dwell and surge technology using a latham bowl, control is performed so that a buffy coat layer composed of a platelet layer and a white blood cell layer is formed at a predetermined position in order to efficiently collect platelets. Is preferred. In such a case, the blood volume of whole blood processed per cycle is, for example, a constant volume determined when the optical sensor in the apheresis device detects the red blood cell layer at a predetermined position. However, depending on the ratio of high and intermediate density components in the blood of the donor, that is, the hematocrit value, it is necessary to pay attention to the throughput per cycle that needs to be circulated outside the body during the apheresis process. In order to deal with such problems, Patent Document 4 proposes that the total flow rate of plasma passing through the centrifuge during the draw step and the rotation speed of the centrifuge be made selective depending on the donor. ing. According to this technique, the whole blood throughput per cycle can be variably controlled so as to be optimal for each individual donor.
Patent No. 2776988 U.S. Pat. No. 4,416,654 US Pat. No. 3,145,713 Japanese Patent No. 3196838

  Apheresis devices operate with various protocols depending on the purpose of collection, some of which are intended to simultaneously collect more than one type of formulation. As an example, the protocol for simultaneous collection of red blood cells and platelets using Disposable Set LN906J manufactured by Hemonetics aims to collect a platelet preparation and a concentrated red blood cell preparation from one blood donor at the same time. The protocol for simultaneous collection of plasma and platelets using Disposable Set LN995J manufactured by Hemonetics aims to collect platelet products and plasma products from one blood donor at the same time. Even in these cases, it is necessary to consider the amount of circulation to be controlled according to the hematocrit value as described above, but from the viewpoint of obtaining two or more preparations, it is necessary to further improve the conventional treatment. There is a case.

  For example, when collecting a concentrated red blood cell preparation, it is desirable to remove as much plasma components as possible from the preparation in terms of preparation quality. If the plasma component to be mixed is small, the amount of the preparation and thus the amount of blood transfusion can be reduced. Therefore, in the above red blood cell and platelet simultaneous collection protocol, platelets are collected by dwell and surge technology using a Latham bowl, and then concentrated red blood cells remaining in the bowl are mixed with a predetermined amount of red blood cell storage solution to obtain a concentrated red blood cell preparation. Have gained. In this case, it is desired to keep the serum hemoglobin level that increases due to the destruction of red blood cells low, but if the red blood cells flow out from the rotating bowl through the outlet port, the red blood cells may be destroyed. Therefore, in order to terminate the blood collection process without causing red blood cells to flow out from the outlet port of the bowl, the centrifugal rotation is stopped after collecting platelets by dwell and surge techniques. However, in this case, the hematocrit value in the bowl (the value obtained by dividing the amount of red blood cells in the bowl by the amount of blood in the bowl) is low, and an appropriate value may not be obtained as a red blood cell preparation derived from 400 mL of whole blood.

  In addition, for example, in the plasma and platelet simultaneous collection protocol described above, the total amount of the collected preparation excluding the anticoagulant (ACD) is 400 mL or less and 12% or less with respect to the blood circulation in the blood donor. Limited. In this protocol, priority is given to the collection of platelet preparations (preparations in which platelets are suspended in plasma). For example, about 200 mL of plasma is used for 10 units of platelet preparations, and this amount of platelet preparations is secured. A plasma preparation is collected from the surplus plasma up to about 200 mL. However, if the donor's hematocrit value is high, the amount of plasma that can be collected per cycle is small, and a predetermined plasma amount may not be obtained upon completion of processing. That is, it is desirable that the plasma product collected at the same time as the platelet product is maximized within the above-mentioned limits, but a sufficient plasma product cannot always be secured depending on the hematocrit value of the blood donor.

  The present invention is characterized by restarting a blood collection process from a blood donor after collecting platelets by a surge technique, or in some cases, after further discharging leukocytes from a centrifuge (centrifugation bowl) (hereinafter, referred to as a blood donor). "Additional blood collection"). The additional blood collection is terminated when a predetermined blood volume (hereinafter referred to as “additional processing volume”) is processed. The additional processing amount is calculated in advance based on the hematocrit value of the donor from the amount of red blood cells that can be additionally filled in the bowl (hereinafter referred to as “additional red blood cell amount”) as long as the red blood cells do not flow out from the outlet port of the centrifuge bowl. Can be predicted. As the hematocrit value of the blood donor, a value measured by an external blood cell counter and inputted to the apheresis device or a value calculated from an already obtained blood throughput obtained by the apheresis device can be used. In some cases, it may be possible to use a hemoglobin value instead of a hematocrit value, such as using an apheresis device in a hospital or the like. If the unit is ignored, hemoglobin (Hb) (g / dL) is about one third of the hematocrit (Ht) (%) (Ht45% ≈Hb15 g / dL). For example, when receiving an input of hemoglobin value In addition, the value can be multiplied by 3 and treated as a hematocrit value.

  The amount of additional red blood cells can be a variable parameter. For example, if the amount of additional red blood cells is 15 mL, in the red blood cell and platelet simultaneous collection protocol, an increase in the amount of red blood cells in the bowl of 15 mL is a decrease in the amount of plasma in the bowl of 15 mL as it is, and a bowl volume of 250 mL is % (Additional red blood cell volume 15 mL / bowl volume 250 mL). In the simultaneous plasma and platelet collection protocol, if the donor hematocrit value is 42%, the amount of plasma that can be collected per cycle increases by about 36 mL (additional red blood cell volume 15 mL ÷ donor hematocrit value 42%), which can be secured. Increased plasma dosage. That is, plasma can be discharged from the bowl by the amount of whole blood additionally flowing into the bowl. In the simultaneous plasma and platelet collection protocol, the target plasma volume cannot be achieved without additional blood sampling in consideration of the number of cycles required for platelet collection, the plasma volume that can be collected per cycle, and the target plasma volume. However, it is preferable to perform additional blood collection selectively.

  It is preferable to use the aforementioned dwell technique as a pre-stage for collecting platelets by surge technique. However, as previously proposed in Japanese Patent Application No. 2002-274519, the dwell technique can be replaced with a high-speed critical flow. The amount of additional processing after platelets are drained by surge technology may vary depending on the number of rotations of the centrifuge, the stop time of the centrifuge after additional blood collection (time required to stop), the shape of the bowl, etc. In any case, the range of possible additional throughput can be easily defined without undue experimentation. For example, the present inventor uses a normal Latham bowl, and when the centrifugal rotation speed is 5600 rpm and the centrifuge stop time is set to 40 seconds, the centrifuge stops when the additional red blood cell volume is set within the range of 15 mL. Sometimes it is confirmed that red blood cells do not flow out of the outlet port of the bowl. However, this additional processing amount can be increased by increasing the centrifugal rotation speed or extending the centrifuge stop time (slow stop).

  According to the present invention, a predetermined amount of additional blood is collected after collecting blood platelets and possibly white blood cells, thereby realizing more flexible control of the processed blood volume. For example, hematocrit in the bowl during simultaneous collection of platelets and red blood cells The value can be increased, and the amount of plasma preparation that can be collected at the time of simultaneous blood plasma and platelet collection is increased. In addition, the restriction | limiting with respect to the total amount of the above-mentioned extract | collected formulation can change according to laws and regulations. It will be apparent to those skilled in the art that the numerical values described for the protocol, cycle, etc. can be changed accordingly.

  Referring to FIG. 1, the apheresis device E1 uses a standard Latham style centrifuge bowl CB1 to separate the anticoagulated whole blood into its components. Of course, however, the centrifuge may be in another form, for example a centrifuge bowl integrally formed by blow molding. The centrifuge bowl CB1 includes a rotatable bowl body, and a fixed inlet port PT1 and outlet port PT2 that are in fluid communication with the interior of the bowl by a rotary seal. A bag or container B1 for storing an anticoagulant (ACD) communicates with a tube T1 with a venous needle through a sterilization filter F2, a pump P3, a tube T2 passing through an air detector D3, and a connector C1. If the whole blood is once pooled and then supplied, the venous needle T1 can be replaced with a whole blood bag (not shown). Alternatively, in some cases, a part of additional blood collection described below can be replaced by a temporarily collected red blood cell preparation. The tube T1 with a venous needle is connected to the air detector D1, the air detector D2, the blood filter F1, the valve V1, the air detector D4, the tube T3 passing through the pump P1, the connector C2, the tube T4, and the inlet port PT1. , In fluid communication with the centrifuge bowl CB1. The outlet port PT2 of the centrifuge bowl CB1 is labeled as plasma suspended on the weigh scale S1 via a tube T5 passing through the line sensor L1, a three-way connector C3, a connector C4, and a tube T8 passing through the valve V2. It is selectively communicated with the container inlet port PT4 of the container B2. The container B4 labeled as air branches from the tube T5 via the connector C3 and passes through the valve V4, and the container B3 labeled as platelet passes from the tube T5 via the connector C4. Are selectively communicated with the outlet port PT2 of the centrifuge bowl CB1 via a tube T9 that branches and passes through the valve V3. The container outlet port PT3 of the container B2 extends through the pump P2 via the tube T7 and is connected to the connector C2.

  Pumps P1, P2 and P3, coupled with valves V1 to V8, are line sensor L1, blood donor pressure monitor (DPM) M1, system pressure monitor (SPM) M2, and air detectors D1, D2, D3 and D4. The direction and duration of the flow through the apheresis device E1 are controlled in accordance with a signal generated by the microcomputer according to an instruction from a microcomputer (not shown). Air detectors D1, D2, D3 and D4 detect the presence or absence of liquid. The pressure monitors M1 and M2 monitor the pressure level in the device E1. The line sensor L1 optically detects the presence of blood components passing through the line sensor L1 from the outlet port PT2. In some cases, the pumps P1 and P2 can be replaced by a single pump disposed along the tube T4 between the connector C2 and the inlet port PT1 of the centrifuge bowl CB1. In this case, however, the critical flow technique described later cannot be used, and the operation of diluting the concentrated erythrocytes with plasma when returning blood cannot be performed.

  In the initial operation, the pumps P1 and P3 are energized to prime the tube T2 of the apheresis device E1 with the anticoagulant from the container B1. The anticoagulant passes through the sterilization filter F2 and the connector C1, and reaches the air detector D2. The air detector D2 detects the presence of the anticoagulant in D2 and terminates the anticoagulant priming operation. During the priming operation, the valves V1 and V4 are opened, and the sterilized air that has flowed out of the centrifuge bowl CB1 by the anticoagulant priming operation enters the container B4.

  Next, the tube T1 with a venous needle is inserted into the blood donor, and the draw step is started. During the draw step, the whole blood collected from the donor through the venous needle tube T1 is mixed by the connector C1 with the anticoagulant supplied from the container B1 by the pump P3. Further, the whole blood mixed with the anticoagulant by the pump P1 is supplied from the inlet port PT1 to the centrifuge bowl CB1 via the tube T3 and the tube T4. The operation of each pump, valve, etc. in the apheresis device E1 is performed according to a desired protocol under the control of a microcomputer (not shown).

  When the centrifuge bowl CB1 rotates, 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 6000 rpm, and is typically 4800 rpm, for example. Within the centrifuge bowl CB1, 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. 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 between them. The plasma layer is the component closest to the outlet port PT2, and is first effluxed through the outlet port PT2 as anticoagulated whole blood is added to the centrifuge bowl CB1 through the inlet port PT1.

  Plasma that has flowed out of the outlet port PT2 during the draw step is collected in the container B2 via the tube T5 passing through the line sensor L1, the valve V2, and the container inlet port PT4. Here, according to the critical flow technique, the plasma collected in the container B2 is circulated from the container outlet port PT3 through the tube T7, the connector C2, and the tube T4 to the centrifugal bowl CB1 through the inlet port PT1 by the pump P2. The In critical flow technology, the total plasma flow through the centrifuge during the draw step, ie the plasma flow in the whole blood drawn in the draw step, and from the vessel B2 to the centrifuge bowl CB1 for whole blood dilution. The total plasma flow that is circulated is referred to as the “critical flow” and is kept constant. Depending on the donor's condition, the whole blood supply rate fluctuates during the draw step and may be zero in some cases, but according to the critical flow technique, plasma is compensated to compensate for this reduction. It can be circulated to stabilize the flow through the centrifuge bowl and prevent disruption of the separation. The circulating plasma also dilutes anticoagulated whole blood, facilitating separation of blood components in the centrifuge bowl.

  An optical sensor (not shown) is applied to the shoulder of the centrifuge bowl CB1 to monitor a layer in which blood components are concentrically formed in the centrifuge bowl. That is, the optical sensor monitors the radius from the rotation axis of the region occupied by the buffy coat in the centrifuge bowl CB1, and detects that this radius has reached a specific value. When the optical sensor detects the red blood cell layer in place, the draw step is complete, valve V1 is closed, pump P1 is stopped, no further blood is taken from the donor, and the dwell phase is initiated. The

  During the dwell, the pump P2 circulates plasma through the centrifuge bowl CB1 at a suitable flow rate, for example, 100 mL / min for a certain period. At this flow rate, the buffy coat is diluted and widened, but the platelets do not exit the centrifuge bowl CB1. As described in U.S. Patent No. 6,057,049, the dwell technique dilutes the buffy coat to achieve better separation of platelets and leukocytes and to allow stabilization of the flow pattern in the centrifuge bowl CB1. Thereafter, a surge step is started and platelets are collected. However, as described above, the dwell technique can be replaced with a high-speed critical flow in accordance with the proposal of Japanese Patent Application No. 2002-274519, and in that case, the transition is made directly from draw to surge.

  In a surge, the speed of pump P2 is increased, for example, in increments of 5-10 mL / min, and plasma is circulated until a platelet surge rate of about 200-250 mL / min is reached. This platelet surge rate is a rate at which platelets can exit the centrifuge bowl CB1, but red blood cells or white blood cells cannot. The plasma leaving the bowl becomes cloudy with platelets, and this cloudiness is detected by the line sensor L1. The line sensor L1 can include an LED that irradiates light to a blood component that passes through the tube T5, and a photoelectric detector that receives light after passing through the blood component. The amount of light received by the photoelectric detector is correlated with the density of the liquid flowing through the tube T5. When platelets first start out of the centrifuge bowl CB1, the output of the line sensor L1 begins to decrease. Valve V3 is opened, valve V2 is closed, and platelets are collected in container B3. If most of the platelets are removed from the centrifuge bowl CB1, clouding of the outflowing liquid is reduced. This decrease in fog is detected by the line sensor L1. Thereafter, the valve V3 is closed and the sampling is finished. Optionally, a white blood cell bag (not shown) can be used to subsequently initiate white blood cell collection.

  After the surge is over, collect additional blood. This can be started automatically after collection of platelets and / or leukocytes, or can optionally be performed manually. The start time may be controlled by separately monitoring the red blood cell layer using, for example, an optical sensor. Similar to the draw step, additional blood collection is performed by supplying anticoagulated whole blood from the inlet port PT1 to the centrifuge bowl CB1 through the tube T3 and the tube T4 by the pump P1. Also in this case, critical flow technology can be used. After the additional blood collection, for example, in the plasma and platelet simultaneous collection protocol, the platelets suspended in the plasma in the container B3 and the plasma in the container B2 are collected as a preparation. In the simultaneous collection protocol for red blood cells and platelets, platelets suspended in the plasma in the container B3 and concentrated red blood cells collected in the container B5 from the centrifugal bowl CB1 by inverting the pump P1 are collected as a preparation. The remaining blood components are returned to the donor in a known manner. In some cases, the red blood cells collected in the container B5 in the previous cycle can be used in place of at least a part of the whole blood from the donor in the additional blood collection after the next cycle.

  As is well known, the apheresis device E1 shown in FIG. 1 is a disposable system comprising a fixed unit incorporating a valve, various sensors, a centrifuge motor, a microcomputer, etc., a centrifuge bowl, a tube, a bag, and the like. (Disposable) is included. Various disposable systems such as the above-mentioned disposable set LN906J and LN995J manufactured by Hamonetics can be used according to various protocols with which the apheresis device operates. FIG. 2 schematically illustrates a disposable system that can be used in practicing the present invention in the apheresis device of FIG. 1 in conjunction with a simultaneous plasma and platelet collection protocol. The symbols used in FIG. 2 correspond to those used for the disposable system in FIG.

  In the simultaneous plasma and platelet collection protocol, when the collection of platelets and / or white blood cells by the surge step is completed, an additional blood collection step is started optionally or automatically. “Optional” includes, for example, that an additional blood collection step can be selected in real time during operation of the apparatus by an operator's key operation. In addition, the automatic selection includes that the apparatus determines the necessity of securing the surplus plasma volume in the additional blood collection step, and automatically performs the additional blood collection step only when it is recognized as necessary. Such a determination is made based on a comparison between the surplus plasma volume when the additional blood collection step is not performed and the target plasma volume that is finally required as a plasma preparation.

  When the additional blood collection step is started, the valve V1 is opened and the pump P1 starts rotating again. Similar to the draw step, plasma flows out through the outlet port PT2 of the centrifuge bowl CB1, passes through the tube T5 and the valve V2, and is collected in the container B2 through the tube T8 and the container inlet port PT4. At this time, whether or not the critical flow using the pump P2 is performed can be selected. The additional blood collection step is continued until the additional processing amount Va is processed by the number of rotations of the pump P1 (for example, one rotation corresponds to 1 mL), starting from the end of the surge step. After the end of the additional blood collection is detected, the rotation of the centrifuge bowl is stopped. When the centrifugal rotation is stopped, red blood cells may flow out, so the blood component flowing out from the bowl is sent to the container B4 via the tube T5 and the tube T6 passing through the valve V4. Here, the additional processing amount Va can be calculated by the following equation.

Va = Vr / Ht
Where Va = additional throughput (mL),
Vr = additional red blood cell volume (mL),
Ht = donor hematocrit (%)
As described above, Vr is a given value that can be derived empirically through experiments, and the donor's hematocrit Ht is a value input by the operator to the apheresis device E1, or a value calculated by the following equation.

Ht = R / Vc
Where Vc = throughput per cycle (mL),
R = amount of red blood cells in the bowl (mL)
R is a given value. For example, if the amount of additional red blood cells and the amount of red blood cells in the bowl are set in advance to 15 mL and 170 mL, respectively, the Ht of the donor whose processing amount per cycle was 450 mL is handled as about 37.8% by the apparatus, and the additional processing amount is About 40 mL. Further, by changing the set value of R, the additional whole blood volume can be finely adjusted.

  The amount of red blood cells R in the bowl means the amount of red blood cells present in the bowl immediately before the surge, and is a value obtained by multiplying the processing amount in that cycle by the hematocrit value of the blood donor. Moreover, it is a value that can be actively changed depending on the setting of critical flow and centrifugal rotation, and the value of 170 mL given as an example is an empirical value when using a critical flow of 60 mL / min and a centrifugal rotation of 5600 rpm. . The amount of additional red blood cells varies depending on the number of rotations and the time required to stop the centrifugal rotation. In the case of 15 mL according to the above example, the centrifugal rotation at 5600 rpm is stopped for 40 seconds without causing the red blood cells to flow out of the bowl. It is possible.

  After a predetermined additional throughput has been processed, the device E1 starts a return step. In the simultaneous plasma and platelet collection protocol, the rotation of the centrifuge bowl CB1 is stopped during the return step, and the blood component remaining in the centrifuge bowl CB1 follows the same path as during the draw step by the reverse rotation of the pump P1. On the contrary, the blood is returned to the blood donor via the tube T1 with a venous needle. At this time, the valve V4 is opened so that air can return to the centrifuge bowl CB1. If the volume of the plasma in the container B2 is sufficient to ensure the target plasma volume, the surplus is removed from the centrifuge bowl CB1 through the container outlet port PT3, the tube T7 and the connector C2 by the rotation of the pump P2. It joins the blood component flow and is returned to the donor while diluting the blood component. When the blood component in the bowl and the plasma in excess of the target plasma volume are returned to the donor, the return step ends when the bowl is empty.

  FIG. 3 schematically illustrates a disposable system that can be used in practicing the present invention in the apheresis device of FIG. 1 in conjunction with a red blood cell and platelet simultaneous collection protocol. The symbols used in FIG. 3 correspond to the symbols used for the disposable system in FIG. In the red blood cell and platelet simultaneous collection protocol, an additional blood collection step is performed only when red blood cells are collected in a return step in the same cycle. In cycles where red blood cells are not collected, only platelets are collected. Usually, the number of cycles required to collect the desired amount of platelets is greater than the number of cycles required to collect the desired amount of red blood cells. That is, unlike the simultaneous plasma and platelet collection protocol aimed at ensuring surplus plasma volume, the additional blood collection step here is mainly aimed at obtaining a high concentration red blood cell preparation by increasing the red blood cell filling amount in the bowl. It is said. The additional blood collection step itself is performed in the same manner as in the first embodiment. However, in this case, after the collection of platelets and / or white blood cells by the surge step is completed and / or after the additional blood collection step is completed, the red blood cell storage solution (MAP liquid, for example, is removed from the container B7 while the centrifuge is rotating. -Consisting mainly of mannitol, adenine and phosphate) at high speed into the centrifuge bowl CB1 to push out the plasma in the bowl and any remaining intermediate density components, in particular white blood cells, out of the bowl. According to this, the amount of plasma mixed in the obtained erythrocyte preparation can be reduced, and leukocytes can be removed.

  In the red blood cell and platelet simultaneous collection protocol, the configuration of the return step differs depending on whether the red blood cells are collected or not. If the red blood cells are not collected, the blood components in the centrifuge bowl CB1 are returned to the donor by reversing the pump P1, possibly with dilution with plasma from the container B2, as in the plasma and platelet simultaneous collection protocol. Returned. In the case of collecting red blood cells, when the return step starts after completion of the additional blood collection, the plasma in the container B2 is rotated from the container outlet port PT3 through the tube T7, the connector C2, the tube T3, and the tube T1 by the rotation of the pumps P1 and P2. And returned to the donor. Similarly, the physiological saline is sent from the container B6 to the donor by the rotation of the pumps P1 and P2 through the tube T11, the filter F3, the valve V6, and the connectors C6 to C7 through the same route as the plasma. Can do. The supply of plasma and physiological saline to the donor can be performed alternately or simultaneously, and is continued until it is detected by the weigh scale S1 that a predetermined amount of plasma has been returned.

  After the plasma / saline is returned to the donor, the donor is released and the red blood cell collection step begins. Since the donor's restraint time ends here, it is effective to shorten the restraint time to return the plasma to the front. A blood component mainly composed of red blood cells in the centrifuge bowl CB1 is sent to the container B5 through the tube T10 through the connector C5 and the valve V5 from the outlet port PT1 and the tube T4 by the rotation of the pump P1. After a predetermined amount of blood component in the bowl is transferred to the container B5, for example, after air is detected by the air detector D4, a predetermined amount of red blood cell preservation solution in the container B7 is passed through the filter F4 and the valve V7. The pump P2 is rotated and transferred to the centrifugal bowl CB1 through the tubes T12, T7, and T4, and mixed with the blood components remaining in the centrifugal bowl. The blood component in the centrifuge bowl to which the red blood cell preservation solution has been added is sent again to the container B5 through the outlet port PT1, the tube T4, and the tube T10 by the rotation of the pump P1. Transferring the red blood cell preservation solution to the centrifuge bowl in this manner is effective in order to reduce the amount of red blood cells remaining in the centrifuge bowl. Further, since the concentration of red blood cells in the centrifuge bowl can be lowered, the load on the red blood cells by the pump can be reduced and the destruction thereof can be prevented, which is effective in improving the quality of the preparation.

  Alternatively, the red blood cell preservation solution can be directly transferred to the container B5. In this case, simultaneously with the supply of the blood component from the centrifuge bowl CB1 to the container B5, the red blood cell preservation solution is taken out from the container B7 through the filter F4, the valve V7, and the connector C7 by the pump P2, and at the connector C2, the centrifuge bowl Mixed into the flow of blood components from CB1. Collecting erythrocyte preservation solution and erythrocytes simultaneously in container B5 in this way is also effective in improving formulation quality by diluting erythrocytes and lowering the concentration to reduce the load caused by the pump and preventing destruction of erythrocytes. It is. Further, the transfer rate can be increased, and the red blood cells and the red blood cell preservation solution are mixed evenly. Also in this case, the centrifuge bowl CB1 can be subsequently washed using the red blood cell storage solution.

  In any of the protocols described in Examples 1 and 2, the cycle consisting of draw, dwell, surge and return steps is repeated as many times as necessary to collect the target blood component and added as necessary. Perform processing steps.

  The apheresis device of the present invention is expected to be useful for the efficient production of blood products in combination with conventional protocols.

It is the schematic which shows typically the preferable Example of the apheresis apparatus of this invention. FIG. 2 is a schematic view of an example of a disposable system used when performing a simultaneous plasma and platelet collection protocol in the apheresis device of FIG. 1. FIG. 2 is a schematic diagram of an example of a disposable system used when the simultaneous red blood cell and platelet collection protocol is performed in the apheresis device of FIG. 1.

Explanation of symbols

E1 Apheresis device CB1 Centrifugal bowl P1-P3 Pump T1-T12 Tube V1-V8 Valve B1-B7 Bag

Claims (20)

A centrifuge having an inlet port and an outlet port for separating whole blood into a low density component, an intermediate density component consisting primarily of platelets and white blood cells, and a high density component;
A first communication device that is in selective communication with the inlet port and the outlet port and is connected to collect low density components from the outlet port and return the collected low density components from the inlet port back to the centrifuge. A container,
Operable to supply a donor's whole blood from the inlet port to the centrifuge and operable to return low density components from the first container to the centrifuge via the inlet port. In an apheresis device having pump means and control means for controlling the pump means,
The control means controls the pump means.
(1) Operate to supply a predetermined whole blood throughput from a donor to the centrifuge for separation into the low density component, intermediate density component, and high density component,
(2) after operating to supply a low density component from the first container to the inlet port to drain at least a portion of the intermediate density component from the centrifuge;
(3) act to supply an additional whole blood throughput that is less than the predetermined whole blood throughput from a donor to the centrifuge without draining high density components from the centrifuge; A characteristic apheresis device. The control means stops the flow of whole blood into the centrifuge prior to the outflow of at least a portion of the intermediate density component, and dilutes the intermediate density component without leaving the centrifuge. 2. The apheresis device of claim 1, wherein the pump means is operated to circulate low density components from the first container to the inlet port to expand the area occupied by the intermediate density components in the centrifuge. The pump means is operated to supply a donor's whole blood from the inlet port to the centrifuge, and a low density component from the first container via the inlet port to the centrifuge. The apheresis device of claim 1, comprising a second pump actuated back to the separator. The pump means is operated to supply a donor's whole blood from the inlet port to the centrifuge, and a low density component from the first container via the inlet port to the centrifuge. Comprising a second pump operated to return to the separator, wherein the control means stops the flow of whole blood into the centrifuge by stopping the first pump, and circulates the low density component. The apheresis device according to claim 2, wherein the apheresis device is controlled to be performed by the second pump. When the control means operates the first pump to supply the predetermined whole blood throughput from the blood donor to the centrifuge, the total flow rate of the low density components passing through the centrifuge is constant. The apheresis device according to claim 3 or 4, wherein the second pump is operated so that the low density component is returned from the first container to the centrifuge. When the control means operates the first pump to supply the additional whole blood throughput from the donor to the centrifuge, the total flow rate of the low density components passing through the centrifuge is constant. The apheresis device according to claim 3, wherein the second pump is operated so that the low-density component is returned from the first container to the centrifuge. The apheresis device according to any one of claims 1 to 6, wherein the additional whole blood throughput is an amount that does not allow a high-density component to flow out of the outlet port of the centrifuge. The apheresis device according to any one of claims 1 to 7, wherein the additional whole blood throughput is determined based on a donor's hematocrit value and / or hemoglobin value. Including a second container for dispensing at least a portion of the effluent intermediate density component, and after processing the additional whole blood throughput to increase the amount of low density component in the first container The apheresis device according to any one of claims 1 to 8, wherein a required amount of the low density component in the first container is dispensed. After processing the additional whole blood throughput, the control means returns the high density component in the centrifuge to the donor with the low density component in the first container that exceeds the required amount. 10. The apheresis device of claim 9, wherein the means is actuated. A second container for fractionating at least a portion of the effluent intermediate density component; and a third container for fractionating the high density component in the centrifuge after processing the additional whole blood throughput. The apheresis device according to claim 1, further comprising: The control means actuated the pump means to (2) supply a low density component from the first vessel to the inlet port to drain at least a portion of the intermediate density component from the centrifuge. And / or (3) red blood cells to push low density components and remaining intermediate density components from the centrifuge after being actuated to supply additional whole blood throughput from the donor to the centrifuge. 12. The apheresis device of claim 11, wherein the apheresis device is operated to send a preservative solution to the centrifuge. 12. The apheresis device of claim 11, wherein after processing the additional whole blood throughput, the control means activates the pump means to return the low density component in the first container to the donor. The control means after the low-density component is returned in the first container, fractionated high density component into the third container, apheresis apparatus according to claim 13. 15. The apheresis device of claim 14, wherein a red blood cell preservation solution is supplied to the third container at the same time as at least a portion of the high density component. The apheresis device according to claim 14 or 15, wherein the red blood cell preservation solution is supplied into the centrifuge to perform one or both of dilution and washing of the high density component. 17. A sensor as claimed in any one of the preceding claims, comprising a sensor arranged to operate in connection with the centrifuge, wherein the supply of the additional whole blood throughput is based on detection by the sensor. Apheresis device. 18. The apheresis device according to claim 17, wherein the sensor monitors a radius from a rotation axis of a region occupied by the intermediate density component in the centrifuge and detects that the radius becomes a specific value. The apheresis device according to any one of claims 1 to 18, wherein whole blood and / or additional whole blood from the donor is supplied from a whole blood bag. 17. The apheresis device according to any one of claims 11 to 16, wherein at least part of the additional whole blood from the donor is replaced by a high density component from the third container.