JP4528863B2 - Apheresis equipment - Google Patents

Description

  The present invention relates to an apheresis device, and more particularly, to an apheresis device capable of producing a concentrated platelet preparation efficiently and with improved safety and quality.

  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.

Among various blood component preparations obtained by apheresis, the demand for concentrated platelet preparations is rapidly increasing. This is particularly due to the need to administer higher amounts of platelets to patients with reduced hematopoietic activity as cancer therapy improves. Platelets are large cell fragments called megakaryocytes located in the bone marrow, and contribute mainly to hemostasis by performing an aggregating action, but also have a role in tissue healing. In normal adults, the platelet count is between 150,000 and 400,000 / mm ³ . If the platelet count is 20,000 / mm ³ or less, various problems such as spontaneous bleeding may occur.

  When obtaining concentrated platelet preparations, it is important to collect platelets from the whole blood provided by the donor in the maximum yield, but it is administered to humans, so it is extremely safe and excellent. It is of utmost importance to be of a good quality. For example, it is known that contamination of a concentrated platelet preparation by leukocytes can cause various non-hemolytic transfusion side effects such as serious immune reaction such as GVH reaction and fever. Technology has been developed. For example, Patent Document 1 relates to a so-called “surge” technique. According to surge technology, whole blood is collected and separated into high density, intermediate density and low density components in a centrifuge (concentrated circle) (so-called “draw” step), and plasma is fractionated and fractionated. Plasma is fed through the centrifuge at a surge flow rate, that is, a flow rate that increases with time. The surge enables preferential separation of platelets from a buffy coat consisting mainly of a mixture of platelets and leukocytes.

In Patent Document 2, a so-called “dwell” step is performed in which plasma is circulated through the centrifuge at a constant rate for a short period of time before platelets are driven out of the centrifuge using surge technology. This technology has succeeded in aligning platelets and leukocytes with close specific gravity within the buffy coat and improving the separation between them. Further, by filtering out the flowing platelets through a leukocyte filter, contamination by leukocytes is further reduced. In the normal intermittent blood flow method, after the required components are collected, the remaining blood components mainly composed of red blood cells are returned to the blood donor (so-called “return” step).
U.S. Pat.No. 4,416,654 Special table hei 8-509403 Mayumi Asada, et al .: Prevention of blood transfusion side effects by washed platelets, Journal of the Japan Society of Blood Transfusion, 48 (1): 32-36, 2002

The concentrated platelet preparation obtained as described above is provided in a form in which platelets corresponding to 10 units (2 × 10 ¹¹ ) are suspended in, for example, 200 ml of plasma. However, even if leukocytes in the blood product are removed, non-hemolytic transfusion side effects such as urticaria and anaphylactic shock, which may be derived from plasma protein components, may still appear. In such a case, as described in Non-Patent Document 1, it is one method to replace all the plasma with a washing solution, but the operation must be complicated. In the current apheresis, automated devices such as the product names Multi and CCS marketed by the applicant, Haemonetics Corporation, are widely used. It is desirable to reduce the plasma component of.

  On the other hand, plasma is currently used as a raw material for producing blood products such as albumin and globulin. If the plasma component in the concentrated platelet preparation can be reduced as described above, the surplus plasma can be effectively utilized for the production of these blood preparations. The present invention aims to solve these problems.

  The apheresis device according to the present invention has a collecting means for collecting whole blood from a donor, an inlet port and an outlet port, a centrifugal separating means for separating the collected whole blood into a plurality of blood components, an inlet port and an outlet port. A first container connected in selective communication with the second container, a second container connected in selective communication with the inlet port and the outlet port, and a first container connected in selective communication with the outlet port. 3, circulating means operable to return the fluid collected from the outlet port to the first or second container to the inlet port, and the concentration of the selected blood component in the fluid flowing out of the outlet port And a control means for collecting a predetermined amount of the blood component selected based on the detected concentration, connected to the collection means, the centrifugal separation means, the circulation means, and the detection means. Consisting of a stage.

  This type of apheresis device includes a disposable circuit (disposable) in which a flexible plastic bag is connected to a centrifuge bowl via a tube, and a blood processing device comprising hardware such as a centrifuge, a valve, and a microcomputer. In combination, both function as a unit when used. For example, collection means for collecting whole blood from a donor typically includes a venous needle and a blood pump. In this case, the venous needle is a part of the disposable, and the blood pump is a part of the blood processing apparatus, and includes a non-contact type pump such as a peristaltic pump. The circulation means can also include a similar pump. The container described above is connected to the centrifuge bowl via a tube, and the communication between the two can be controlled by a valve on the hardware side. The centrifuge bowl is like a standard Latham bowl described in, for example, US Pat. No. 3,145,713 and has an inlet port and an outlet port to separate the collected whole blood into components. To do.

  According to the present invention, the control means (1) collects the whole blood from the donor and separates it into a plurality of blood components by the centrifugal separator, and (2) collects the low density component in the first container. Circulating to the centrifuge means, (3) collecting a first portion of the intermediate density component flowing out of the centrifuge means in a second container, and (4) of the intermediate density component flowing out following the first portion. The second part containing the maximum concentration is collected in a third container, (5) the third part of the intermediate density component flowing out following the second part is collected in the second container, and (6) stored. It is configured to operate with a cycle consisting of adding liquid to the third vessel. The control means can be realized by using a microcomputer, and this microcomputer may be appropriately programmed in advance to perform these operations, and may be configured so that an appropriate program can be loaded depending on the case. May be. It is convenient if the program is stored in a ROM in a card format and used in a blood processing apparatus together with a required disposable circuit.

  (1) is a normal draw operation. Whole blood is collected either directly from a donor (donor) via a punctured venous needle or once pooled in a container such as a bag and then collected in a centrifuge bowl using a blood pump. Whole blood is collected from the donor at a flow rate of, for example, about 60-80 ml / min and mixed with the anticoagulant at a ratio of about 10: 1. In this case, as has been conventionally done, in order to facilitate the collection of whole blood, once the separated plasma is circulated into the centrifuge at a constant flow rate of, for example, about 20 to 30 ml / min. The whole blood may be diluted by recirculation using a pump included in the means (critical flow). Plasma is collected, for example, in the first container described above. Collection of whole blood in the draw step is performed until it is detected that the volume of blood components separated in the centrifuge bowl, typically the volume of the red blood cell layer, has reached a predetermined amount. The detection can be performed, for example, using an optical sensor that monitors the radius of the region occupied by the blood component separated in the centrifuge bowl and detects that this radius has reached a specific value.

  (2) is a surge operation, but usually a dwell operation is performed before that. 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 a centrifuge bowl by a circulation pump, and the flow rate is larger than the collected blood flow rate for a short time. Circulated over time (eg, about 100 ml / min for about 20-25 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. When moving to surge operation, the circulation pump supplies plasma at a surge flow rate to allow platelets to flow out of the centrifuge bowl. The surge, for example, starts at about 100 ml / min and is increased in 10 ml / min increments until a platelet surge flow rate of about 200 ml / min is reached. The plasma exiting the outlet port of the bowl becomes cloudy with platelets, and this cloudiness is detected by the detection means. The detection means is, for example, a line sensor arranged in association with a tube extending from the outlet port. The line sensor consists of an LED that emits light across the fluid through the tube and a photoelectric detector that receives the 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.

  Conventionally, all intermediate density components, ie platelets, that flow out of the centrifuge bowl with plasma due to surge are collected in a platelet collection bag. However, according to the present invention, the first and last portion of the platelet fraction flowing out of the centrifuge bowl is collected in the second container ((3) and (5)), and the intermediate portion containing the maximum concentration of platelets. Collect portions in a third container ((4)). The platelet component flowing out of the centrifuge bowl usually has a temporal concentration distribution with a single peak, with the first and last part being rich in plasma. In the present invention, these parts are collected in the second container, and the intermediate part containing the maximum concentration of platelets is collected in the third container, so that only the higher concentration part is used in the concentrated platelet preparation. The first and last portions collected in the second container are returned to the centrifugal separation means by the circulation means in the next cycle, and the platelets contained in those parts are collected.

  According to the present invention, the cycle includes (6) an operation of adding the preservation solution to the third container. As the preservation solution, well-known ones mainly composed of physiological saline, Ringer's solution and the like are used, and examples thereof include acetate Ringer's solution (M-sol) and glucose-added acetate Ringer's solution (G-sol). In addition, T-Sol, InterSol (both Baxter), SSP + (MacoPharma) and Composol-PS (Freseniums) are also available on the market. In some cases, it may contain an inactivating agent for inactivating viruses and bacteria. Examples of inactivating agents include psoralen compounds and riboflavin. The preservation solution can be added to the third container by a drop by, for example, putting it in a preservation solution bag, suspending it above the apheresis device, and selectively opening and closing the valve. The tube extending to the third container can be provided with a leukocyte filter, but the preservation solution is preferably added to the third container via this leukocyte filter. Thereby, it becomes possible to wash out the platelets trapped in the leukocyte filter. When a leukocyte filter is used, it is preferable to control so that the leukocyte filter is previously moistened with plasma prior to filtration of the intermediate portion containing platelets at a high concentration. After filtration of the intermediate part, the leukocyte filter can be washed out with a preservative or plasma.

  The amount of the preservation solution is calculated based on the second portion including the maximum concentration of the platelet component. For example, if the amount of the platelet component that can be collected per cycle, that is, the amount of the second part consisting of plasma containing the highest concentration of platelets is 20 ml, the target volume when this is collected for a predetermined cycle is the target. Add the preservative solution in a volume that is equal to the product subtracted from the product volume. The stock solution can be added at the end of each cycle.

  When a line sensor is used as the detection means, reading is performed while plasma is flowing through a tube extending from the outlet port of the centrifuge bowl, and this reading is established as a reference value. Usually, the reading is converted to a voltage, and the reference value is set as a reference voltage, for example 4 volts, and compared with the subsequent reading voltage. According to a preferred embodiment of the present invention, the collection of the first part of the platelet component is performed when the output voltage of the line sensor is 95 to 90% of the reference value, more preferably 95%, and more preferably 75 to 65%. Preferably it is performed until it becomes 70%. These ranges are considered to be suitable ranges for sorting low-concentration platelets separately from high-concentration platelets. Specifically, 95% is the level at which platelets begin to flow out with a normal surge, and in order to meet the platelet concentration required for platelet products (around 2.5 million / μL), Collection should normally be at a level of 70% or higher. However, since the optimal range may vary depending on the donor, it can also be adjusted appropriately individually from the viewpoint of reducing the amount of platelets desired and the amount of plasma contained in the preparation, based on the hematocrit value and the like. .

  When the second portion including the maximum concentration portion of platelets is collected, if a peak corresponding to the maximum concentration portion is detected, the reference value of the line sensor can be reset with this peak value as zero. In this case, the collection of the second part is preferably performed until the output of the line sensor reaches 35 to 45%, more preferably 40% of the reset reference value, and then the collection of the third part is performed. Is preferably performed until the output of the line sensor reaches 45 to 55% of the reset reference value, more preferably 50%. 40% is preferred because of the point of view corresponding to the platelet concentration required for the platelet preparation. The level of 50%, which is the end point of collection of the third part, is defined from the viewpoint of preventing leukocyte contamination, as with the end point of normal platelet collection. When it is 55% or more, leukocyte contamination becomes excessive. However, even in this case, these ranges can be changed as appropriate. For example, the collection of the third part can be performed until the range of 70 to 90% of the reset reference value is reached depending on the situation. is there.

  If the whole blood to be processed is obtained directly from the donor, a return step is performed after the surge step, and blood components remaining in the centrifuge bowl, such as red blood cells and white blood cells, are returned to the donor. . As described in Japanese Patent No. 2575769, in this case, a blood component can be diluted by using a circulation pump to improve the blood return efficiency. The cycle is then repeated as many times as desired.

  According to the present invention, it is possible to partially replace plasma in a concentrated platelet preparation, for example, 50 to 70%, or 60 to 80% depending on conditions, with a preservation solution. Therefore, the risk of non-hemolytic transfusion side effects can be reduced accordingly, and a safer and higher quality preparation can be provided. In addition, the apheresis device of the present invention only needs to make a partial change to the conventional disposable circuit, and does not require a hardware change. Therefore, the additional cost required for improvement can be reduced, and an automated operation can be performed. It can be easily realized. Furthermore, the surplus plasma after the substitution can be effectively used as a raw material for producing blood products such as albumin and globulin.

1 is a schematic view of a preferred embodiment of the apparatus used in the present invention. 2 is a graph showing the circulation pump flow rate (curve a) and the line sensor output value (curve b) in ml / min at different stages of the blood separation process for the apparatus of FIG. 1 used in the present invention. It is a graph which shows the relationship between the line sensor output value and collection | sampling to a bag in the surge stage of the blood separation process performed with the apparatus of FIG.

  Referring now to FIG. 1, the apheresis device 10 includes a disposable circuit as shown, hardware such as pumps P1-P3 and valves V1-V8, and a microcomputer (not shown). The disposable circuit uses a standard Latham centrifuge bowl 11. As is well known, the centrifuge bowl 11 includes a rotatable bowl body 12 and fixed inlet and outlet ports PT1 and PT2 in fluid communication with the interior of the bowl by a rotary seal. The inlet port PT1 is in fluid communication with a venous needle (not shown) via the blood filter F1 and the tube 21 when the valve V1 is open. Tube 21 is made of a blood compatible material, which is the case for all tubes and bags of device 10.

  The outlet port PT2 is selectively communicated with the first container 13 for collecting plasma by the valve V2 and the tubes 22,23. The first container 13 is selectively communicated with the valve V3 and the tubes 24 and 25 so as to return to the inlet port PT1. Similarly, a second container 14 for collecting a low concentration portion of platelets is selectively communicated with the outlet port PT2 via valve V4 and tubes 22, 26, and via valve V5 and tubes 27, 25. In selective communication with the inlet port PT1.

  The anticoagulant is supplied from a container (not shown) through the tube 28 by the anticoagulant pump P1, and is in fluid communication with the venous needle. The anticoagulant pump P1 may be of the same type as the blood pump P2 and the circulation pump P3, and in combination with the valves V1-V7, controls the direction and time of flow through the device 10. The tube 22 extending from the outlet port PT2 is provided with a line sensor LS for detecting the concentration of the blood component passing therethrough.

  A third container 15 is selectively connected to the outlet port PT2 through a valve V7 and tubes 22, 29, and 30. The tube 30 is provided with a leukocyte filter F2, and a fourth container 16 is provided for collecting platelets from the branch of the tubes 29 and 30 through the tube 31 before passing the leukocyte filter F2. It has been. Further, this branch is connected to the storage solution bag 17 through the tube 32 and the valve V8.

  In the initial operation, pumps P1 and P2 are energized to prime tube 21 of device 10 with an anticoagulant. During the priming operation, the valve V4 is open, and sterile air that has flowed out of the bowl 12 with the anticoagulant enters the second container 14. The venous needle is then punctured by the donor and the draw phase is started. The apparatus 10 performs four successive stages, ie, draw, dwell, surge and return, and the pump flow rate of the circulation pump P3 during the draw, dwell and surge stages is graphically illustrated by curve a in FIG. ing. During the draw, whole blood is collected from the donor at a flow rate of about 60-80 ml / min using pumps P1 and P2 and mixed with the anticoagulant.

  When the bowl 12 is rotated, the anticoagulated whole blood introduced to the bottom of the bowl is separated into components such as red blood cells, white blood cells, platelets and plasma by centrifugal force. These components are separated into different fractions depending on the density. Higher density components, ie red blood cells, are pushed to the outer wall of the bowl 12, while less dense plasma is present inside the bowl. A buffy coat layer composed of platelets and leukocytes is formed between the low density component and the high density component. As anticoagulated whole blood is additionally processed in bowl 12 through inlet port PT1, plasma is drained through outlet port PT2. The plasma is collected in the first container 13 and circulated to the centrifuge bowl 12 using a circulation pump P3 as necessary. If the optical sensor that monitors the bowl shoulder detects that the buffy coat is at a specific radius called the surge radius, the draw cycle is completed, the whole blood flow is stopped, and the dwell phase begins. . Upon dwell, the circulation pump P3 circulates plasma from the first container 13 through the bowl 12 at, for example, about 100 ml / min for about 20-25 seconds. As described above, at this flow rate, the buffy coat is widened to improve separation of platelets and leukocytes inside, but platelets do not exit the bowl 12.

  After the dwell, the surge phase begins. In the surge, the flow rate of the circulation pump P3 is increased, for example, in increments of 10 ml / min to reach a platelet surge flow rate of about 200 ml / min. Plasma passing through the tube 22 extending from the bowl 12 becomes cloudy with platelets, and this cloudiness is detected by the line sensor LS as shown by curve b in FIG. A reference value for the line sensor LS can be established during the dwell.

  FIG. 3 shows the details of platelet collection at the surge stage. As platelets first begin to exit bowl 12, the output of the line sensor begins to decrease. When the reference value is 100%, the valve V4 is opened and the valve V2 is closed at the point A of the curve b in FIG. 3 where the output of the line sensor LS is 95%. Are collected in a second container 14. Subsequently, at the point B where the output of the line sensor LS is 70% of the reference value, the valve V7 is opened, the valve V4 is closed, and the intermediate portion including the maximum platelet concentration is transferred from the fourth container 16 to the leukocyte filter F2. To be collected in the third container 15. Thereafter, the output of the line sensor LS becomes a peak value, and at this point, the entire depth of the curve with respect to the reference value is taken. At point C where the output signal of the line sensor LS has increased by 40%, the valve V7 is closed, the valve V4 is opened again, and the last part of the surge where the platelet concentration is low is collected in the second container 14 again. Is done. This collection continues until point D where the output signal of the line sensor LS has increased by 50%, at which point the surge is terminated.

  Thereafter, by controlling the valve V8, the preservation solution is added from the preservation solution container 17 to the third container 15 via the leukocyte filter F2. The preservation solution is added at the end of each cycle, but the third container 15 is suspended with the fourth container 16 and the bottom of the third container 15 is located below the bottom of the fourth container 16. Can be arranged as follows. As a result, the liquid can be continuously filled between both containers, and the occurrence of an air block can be prevented. After the final cycle, the third container 15 can be moved downward to filter out any liquid remaining in the fourth container 16. However, other types of implementation are possible, such as providing a valve between the containers 15 and 16. The amount of preserving solution added is calculated as described above based on the amount of blood components collected in the third container 15.

  After the platelets are collected, the device begins the return phase. During the return, the rotation of the bowl 12 is stopped, the blood pump P1 is rotated in the reverse direction, and the remaining blood components in the bowl 12 are returned to the donor through the venous needle by opening the valve V1.

  Depending on the amount of platelets required, this cycle of draw, dwell, surge and return is performed as many times as necessary. During the draw, the anticoagulated whole blood entering the bowl 12 can be diluted with a solution such as saline from a container (not shown) instead of plasma using valve V6. Also, plasma containing low concentrations of platelets collected in the second container 14 at the first and last part of the surge opens the valves V5 and V4, rotates the circulation pump P3 and puts it in the bowl 12 during the draw. Can be supplied. This plasma contains a considerable amount of platelets with less leukocyte contamination compared to the middle part of the surge, but reusing them can increase the recovery rate of platelets. it can.

Example 1 and Comparative Example 1

  As the apheresis device 10 shown in FIG. 1, concentrated platelets were collected using CCS, which is an apheresis device of the present applicant, Haemonetics Corporation. In both the examples and comparative examples, a cycle consisting of draw, dwell, surge, and return was executed a predetermined number of times according to the blood donor, but in the case of the example, centrifugation from the start of the surge to 95 to 70% of the line sensor reference value. Collect the bowl outflow and the centrifugal bowl outflow up to 50% after the line sensor output reaches the reference value after the bottom of the line sensor output, in a separate container from the platelet collection container. Returned to the centrifuge bowl during cycling. Also, T-Sol (Baxter) was added from the stock solution container at the end of each cycle as a stock solution calculated for the intermediate effluent. The results are shown in Table 1.

Example 2 and Comparative Example 2
Concentrated platelets were collected in the same manner as Example 1 and Comparative Example 1. As the preservation solution of the examples, those shown in Table 2 were used. The results are shown in Tables 2 and 3.

As understood from the results of Tables 1 to 3, there is no significant difference in the number and yield of collected platelets, the collection time, and the degree of contamination with white blood cells. In No. 2, 64% could be replaced with the stock solution. In the case of Example 2, the collected platelet concentration determined from the number of platelets in the bag and the collected amount was about 321 × 10 ⁴ μL, which was about 2.4 times that of Comparative Example 2 about 132 × 10 ⁴ μL. Moreover, about 130 mL of plasma on average could be collected with respect to the comparative example 2 by substituting with the preservation solution.

10 apheresis device 11 centrifuge 13 first container 14 second container 15 third container P2 blood pump P3 circulation pump LS line sensor

Claims (11)

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 connected in selective communication with the inlet and outlet ports;
A second container connected in selective communication with the inlet and outlet ports;
A third container connected in selective communication with the outlet port;
Circulating means operable to return fluid collected from the outlet port to the first container or the second container to the inlet port;
Detection means for detecting the concentration of a selected blood component in the fluid flowing out of the outlet port;
Concentrated platelet collection comprising the collection means, the centrifuge means, the circulation means, and a control means connected to the detection means for collecting a predetermined amount of a blood component selected based on the detected concentration An apheresis device for
The control means controls the apheresis device,
(1) Whole blood is collected from a donor and separated into a plurality of blood components by the centrifugal separation means,
(2) collecting low density components in the first container and circulating them to the centrifuge means;
(3) collecting the first portion of the intermediate density component flowing out from the centrifugal separator in the second container;
(4) collecting in the third container a second part containing the maximum concentration of intermediate density components flowing out following the first part;
(5) collecting a third portion of the intermediate density component flowing out following the second portion into the second container;
(6) Operate with a cycle consisting of adding a preservative solution to the third container, and the first and third portions of the intermediate density component collected in the second container are transferred to the next cycle. At the time, the apheresis device is controlled to return to the centrifugal separation means by the circulation means . The apheresis device according to claim 1, wherein the control means calculates the amount of the preservation solution based on the second portion of the intermediate density component. The detection means comprises at least one line sensor, the line sensor having a reference value established for the low density component;
The collection of the first portion of the intermediate density component is performed until the output of the line sensor is 75 to 65% of the reference value,
The apheresis device according to claim 1, wherein the collection of the second portion of the intermediate density component is performed until the output of the line sensor is 35 to 45% of the reference value with respect to the output at the maximum density. The detection means comprises at least one line sensor, the line sensor having a reference value;
The collection of the first portion of the intermediate density component is performed until the output of the line sensor is 95 to 90% of the reference value and is 75 to 65%.
Collection of the second portion of the intermediate density component is performed until the output of the line sensor is 35-45% of the reference value relative to the output at the maximum density,
The apheresis device according to claim 1, wherein the collection of the third portion of the intermediate density component is performed until the output of the line sensor is 45 to 55% of the reference value with respect to the output at the maximum density. The collection of the first portion of the intermediate density component is performed in a range where the output of the line sensor is 95 to 70% of the reference value,
The apheresis device according to claim 4 , wherein the collection of the third portion of the intermediate density component is performed in a range in which the output of the line sensor is 40 to 50% of the reference value with respect to the output at the maximum density. The apheresis device according to any one of claims 1 to 5 , wherein the third container is connected to the outlet port via a leukocyte filter, and the preservation solution is added to the third container via the leukocyte filter. . And further comprising a fourth container for collecting the second portion of the intermediate density component prior to the third container, wherein the third container and the fourth container are connected via a leukocyte filter, The apheresis device according to any one of claims 1 to 5 , wherein a preservation solution is added to the third container via the leukocyte filter. The collection means includes a venous needle and a blood pump;
The apheresis device according to any one of claims 1 to 7 , wherein the circulation means includes a circulation pump and a valve for controlling selective communication between the first and second containers and the inlet port and the outlet port. The apheresis device according to any one of claims 1 to 8 , wherein the control means returns blood components remaining in the centrifugal separation means to the blood donor using the collection means during the cycle. The apheresis device according to any one of claims 1 to 9 , wherein the low density component is plasma and the intermediate density component is platelets. The apheresis device according to any one of claims 1 to 10 , wherein the preservation solution contains an inactivating agent.