WO2007119401A1

WO2007119401A1 - Blood component collecting apparatus

Info

Publication number: WO2007119401A1
Application number: PCT/JP2007/055391
Authority: WO
Inventors: Yoshiki Takagi
Original assignee: Terumo Kabushiki Kaisha
Priority date: 2006-03-17
Filing date: 2007-03-16
Publication date: 2007-10-25
Also published as: JP4956528B2; JPWO2007119401A1

Abstract

A blood component collecting apparatus structured so that in each of the transition from the first plasma collecting step to the first constant-rate plasma circulating step and the transition from the second plasma collecting step to the second constant-rate plasma circulating step, the liquid feeding rate of second liquid feeding pump is increased while continuing the operation of first liquid feeding pump. Accordingly, in each of the first constant-rate plasma circulating step and the second constant-rate plasma circulating step, while collecting plasma in a plasma collection bag, not only is the plasma collected in the plasma collection bag circulated into a blood storage space of centrifugal separator via a plasma circulation line, etc. but also the flow rate of liquid component introduced in the blood storage space is made greater than that of liquid component introduced in the blood storage space during the plasma collecting step.

Description

Specification

Blood component collection device

Technical field

The present invention relates to a blood component collection device.

Background art

[0002] When collecting blood, for the purpose of effective use of blood and reduction of burden on blood donors, blood is separated into each blood component by centrifugation or the like, and only components necessary for the transfuser are collected. Ingredients are collected and returned to the donor!

[0003] For such component blood collection !, blood collected from a blood donor using a blood component collection device is introduced into a blood component collection circuit, and a centrifuge bowl installed in the blood component collection circuit; It is separated into plasma, buffy coat and erythrocytes by a centrifuge, and platelets (platelet containing plasma) are separated from the buffy coat, and platelets containing plasma are collected in a platelet collection bag to obtain a platelet product The plasma is also collected in a plasma collection bag and used as a raw material for the plasma product or plasma fractionation product, and the remaining plasma, white blood cells and red blood cells are returned to the donor (see, for example, Japanese Patent No. 2776988) ).

[0004] In this blood component collection device, a plasma collection step (draw) for collecting plasma in a plasma collection bag, the collection of the plasma is stopped (interrupted), and a plasma is collected from the plasma collected in the plasma collection bag A plasma circulation process (dwell) that circulates to pass through, and a platelet collection process that circulates the plasma collected in the plasma collection bag to the centrifuge so that the flow rate increases and collects platelets in the platelet collection bag (Surge) and a blood return process (return) in which the remaining blood components are returned to the donor. In the plasma collection step, the plasma collected in the plasma collection bag is also circulated so as to pass through the centrifuge.

[0005] However, in the conventional blood component collection device, since the collection of plasma is stopped and the plasma circulation process is performed, it takes a long time to collect the blood, and thus the occupation time of the blood component collection device is increased. In addition, there is a disadvantage that the burden on blood donors also increases.

Disclosure of the invention An object of the present invention is to provide a blood component collection device capable of shortening the blood collection time while increasing the recovery rate of collected blood cell components.

In order to achieve the above object, the blood component collection device of the present invention comprises:

A blood collection means comprising a hollow needle for collecting blood from a donor,

A blood separator for separating blood collected by the blood collecting means;

A plasma collection bag for collecting plasma separated by the blood separator;

A blood component collection bag for collecting predetermined blood cell components separated by the blood separator;

Blood comprising: a blood processing line connecting the hollow needle and the inlet of the blood separator; a branching force provided in the blood processing line; and a blood circulation line connected to the plasma collection bag. Component collection circuit;

A first liquid delivery means installed in the blood treatment line and delivering at least a fluid in the blood treatment line;

A second liquid feeding means installed in the plasma circulation line and feeding at least the plasma collected in the plasma collection bag;

The collected blood is separated and collected in the plasma collection bag by the plasma collection step of collecting plasma in the plasma collection bag by the operation of the first liquid delivery means and the operation of the second liquid delivery means. Blood components for collecting blood components by performing a plasma circulation step for circulating the collected plasma to the blood separator via a plasma circulation line and a blood component collection step for collecting a predetermined blood cell component in the blood component collection bag A collecting device,

When shifting from the plasma collection step to the plasma circulation step, the amount of liquid fed by the second liquid feeding unit is increased while continuing the operation of the first liquid feeding unit, thereby the plasma circulation step. In this case, while collecting plasma in the plasma collection bag, the plasma collected in the plasma collection bag is circulated to the blood separator via a plasma circulation line, and a liquid introduced into the blood separator is collected. The flow rate of the sex component is configured to be larger than the flow rate of the liquid component introduced into the blood separator in the plasma collection step.

According to the present invention, the flow rate of the liquid component introduced into the blood separator is relatively reduced. In other words, since the plasma circulation process set to be larger than the flow rate in the plasma collection process is executed, for example, blood cell components (for example, platelets) to be collected confined by the separated red blood cell layer or the like are collected. Can be washed out reliably. Thereby, the recovery rate of the blood cell component can be improved.

In the plasma circulation process, blood is collected from a donor and collected in a plasma collection bag, so that the time for collecting blood can be shortened. Thereby, the occupation time of the blood component collection device can be reduced, and the burden on the blood donor can be reduced.

[0007] In the blood component collection device of the present invention, the flow rate of the liquid component introduced into the blood separator in the plasma circulation step is preferably 40 to 250 mL / min! /.

As a result, the blood cell component collected by the separated red blood cell layer can be surely washed out while preventing the outflow of the blood cell component collected by the blood separator force, and the buffy coat layer can be washed out. An excessive increase in internal viscosity can be prevented, and the recovery rate of collected blood cell components can be improved.

In the blood component collection device of the present invention, the flow rate of the liquid component introduced into the blood separator in the plasma circulation step and the plasma collection step! The difference from the flow rate of the liquid component introduced into the blood separator is preferably 10 to 220 mLZmin! /.

In the blood component collection device of the present invention, the second liquid feeding means is activated during the plasma collection step, and the plasma collected in the plasma collection bag is passed through the plasma circulation line. And is preferably configured to circulate through the blood separator.

Thereby, the collection rate of the collected blood cell components can be further improved.

[0010] In the blood component collection device of the present invention, the second feeding is performed so that the flow rate of the liquid component introduced into the blood separator becomes a predetermined target value during the plasma collection step. It is preferable that the operation of the liquid supply means is controlled to adjust the liquid supply amount of the second liquid supply means. This reduces the amount of blood collected and places an excessive load on the blood and blood components in the blood separator (for example, if the centrifuge is used as a blood separator, excessive centrifugation). It is possible to prevent the recovery rate from decreasing.

[0011] In the blood component collection device of the present invention, in the plasma circulation step, the second liquid feeding means is operated so that the flow rate of the liquid component introduced into the blood separator becomes a predetermined target value. It is preferable that the second liquid feeding means is controlled to control the liquid feeding amount.

This reduces the amount of blood collected and places an excessive load on the blood and blood components in the blood separator (for example, if the centrifuge is used as a blood separator, excessive centrifugation). It is possible to prevent the recovery rate from decreasing.

In the blood component collection device of the present invention, the plasma collection step is executed a plurality of times before the blood component collection step, and the plasma circulation step is executed between the plasma collection steps. It is preferred to be structured.

[0013] In the blood component collection device of the present invention, the blood component collection device includes the plasma collection step, the plasma circulation step, the blood component collection step, and a return for returning the remaining blood components to the donor. It is preferable that at least one cycle of a blood component collecting operation including a blood process is performed.

As a result, the blood collection process (plasma collection process) and the return process can be repeated using a single blood collection needle (hollow needle), so that the donor (donor) is restrained in both arms. The burden on blood donors can be reduced.

In the blood component collection device of the present invention, the predetermined blood cell component is preferably platelets.

As a result, platelets confined by the separated red blood cell layer or the like can be reliably washed out, and the platelet recovery rate can be improved.

[0015] The blood component collection device of the present invention,

A centrifuge for separating blood collected by the blood collection means; Connecting a plasma collection bag for collecting plasma components separated by the centrifuge, a platelet collection bag for collecting platelet components separated by the centrifuge, and the hollow needle and the inlet of the centrifuge A blood component collection circuit comprising: a blood treatment line that branches; a branching force provided in the blood treatment line; and a plasma circulation line that is connected to the plasma collection bag;

A first liquid feeding means installed in the blood processing line for transferring a liquid in the blood processing line;

A second liquid feeding means installed in the plasma circulation line for transferring the liquid in the plasma collection bag;

A blood collecting step of operating the first liquid feeding means to transfer the blood collected by the blood collecting means to the centrifugal separator and collecting the plasma component separated by the centrifugal separator in the plasma collection bag; The second liquid feeding means is operated to transfer the plasma component collected in the plasma collection bag to the centrifuge, and the plasma component is circulated between the plasma collection bag and the centrifuge. The plasma circulation step and the second liquid feeding means are operated to transfer the plasma component collected in the plasma collection bag while accelerating at a predetermined acceleration, and the platelet component flowing out from the centrifuge is transferred to the platelet A blood component collecting apparatus having a first liquid feeding means and a control means for controlling the operation of the second liquid feeding means so as to execute a platelet collecting step for collecting in a collection bag. And

The control means operates the second liquid supply means without interrupting the blood collection process while the first blood supply means is operated to execute the blood collection process. The plasma circulation step is executed, and the platelet collection step is executed after the blood collection step is completed.

[0016] In the blood component collecting device of the present invention, the control means performs a plurality of times without interrupting the blood collecting step during the blood collecting step before executing the platelet collecting step. Preferred to be configured to perform the plasma circulation process.

In the blood component collection device of the present invention, it is preferable that the control means is configured to execute the platelet collection step after performing the blood collection step alone. Brief Description of Drawings FIG. 1 is a plan view showing a first embodiment of a blood component collection device of the present invention.

[FIG. 2] FIG. 2 is a partially cutaway cross-sectional view showing a state in which a centrifuge is attached to the centrifuge driving device provided in the blood component collection device shown in FIG.

FIG. 3 is a flowchart for explaining the operation of the blood component collection device shown in FIG. 1.

FIG. 4 is a flowchart for explaining the operation of the blood component collection device shown in FIG. 1.

FIG. 5 is a diagram for explaining the characteristics of the blood component collection device shown in FIG. 1.

FIG. 6 is a diagram for explaining the operation control of the second liquid feeding pump of the blood component collection device shown in FIG. 1.

FIG. 7 is a diagram for explaining another operation control of the second liquid feeding pump of the blood component collection device shown in FIG. 1.

BEST MODE FOR CARRYING OUT THE INVENTION

Hereinafter, the blood component collection device of the present invention will be described in detail based on preferred embodiments shown in the accompanying drawings.

FIG. 1 is a plan view showing a first embodiment of a blood component collection device of the present invention, and FIG. 2 shows a centrifuge in a centrifuge driving device provided in the blood component collection device shown in FIG. FIG. 4 is a partially cutaway sectional view of a state where the device is mounted.

[0021] A blood component collection apparatus 1 shown in FIG. 1 separates blood into a plurality of blood components and separates the separated blood cell components, which are platelets (platelets including plasma) (blood components) and plasma (blood components). Liquid component). This blood component collection device 1 has a rotor 142 having a blood storage space 146 therein, an inlet 143 and an outlet (outlet) 144 communicating with the blood storage space 146, and the inlet 142 is rotated by the rotation of the rotor 142. The first line 21 that connects the centrifuge (blood separator) 20 that centrifuges the introduced blood in the blood storage space 146, the blood collection needle (blood collection means) 29, and the inlet 143 of the centrifuge 20 21 The second line 22 connected to the outlet 144 of the centrifuge 20, the third line 23 connected to the first line 21, and the first line 21 via the tubes 49 and 50. A plasma collection bag (collection bag) 25 connected and connected to the second line 22 via tubes 43 and 44; Air bag 27b connected to the second line 22 via the tube 42 and an intermediate dog (temporary storage bag) connected to the second line 22 via the tubes 43 and 45 (collection bag) 27a And a platelet collection bag (collection bag) 26 connected to the intermediate bag 27a via the tubes 46, 47 and 48, and a bag 28 connected to the platelet collection bag 26 via the tube 51. A blood component collection circuit (collection circuit) 2 is provided.

[0022] Furthermore, the blood component collection device 1 includes a centrifuge drive device 10 for rotating the rotor 142 of the centrifuge 20 and a first liquid feed pump for the first line 21 (first Liquid feeding means) 11, a second liquid feeding pump (second liquid feeding means) 12, a third liquid feeding pump (third liquid feeding means) 13 for the third line 23, A plurality of (in this embodiment, first to sixth six) channel opening / closing means 81, 82, 83, 84, 85, 86, which can open and close the middle of the channel of the blood component collection circuit 2, and centrifugation Control unit (control means) for controlling the separator driving device 10, the first liquid feeding pump 11, the second liquid feeding pump 12, the third liquid feeding pump 13, and the plurality of flow path opening / closing means 81 to 86. 3), turbidity sensor (platelet concentration sensor) 14, optical sensor 15, weight sensor 16, and a plurality (6 in this embodiment) of bubble sensors 31, 32, 33, 34, 35, 36 And with There Ru.

Therefore, first, blood component collection circuit 2 will be described.

This blood component collection circuit 2 connects a blood collection needle (hollow needle) (blood collection means) 29 for collecting blood from a donor (blood donor) and an inlet 143 of a centrifuge 20 and connects a first pump tube 21g to The first line 21 (blood collection and blood return line) (blood treatment line) 21 that is also used as both a blood collection line and a blood return line, and one end side to the outlet (outlet) 144 of the centrifuge 20 A second line 22 connected, a third line (anticoagulant infusion line) 23 connected near the blood collection needle 29 of the first line 21 and having a third pump tube 23a, and a first line The tube 50 connected to the centrifuge 20 side from the first pump tube 2 lg of the line 21, the tube 49 connected to the tube 50, a part of which constitutes the second pump tube 22 a, and the second Tube 43 connected to line 22 and tube connected to tube 43 , A plasma collection bag 25 connected to tubes 44 and 49, a tube 42 connected to the second line 22, an air bag 27b connected to the tube 42, and a tube connected to the tube 43. 45 and the intermediate bag 27a connected to the tube 45 and the intermediate bag 2 Tube 46 connected to 7a, tube 47 connected to tube 46, tube 48, platelet collection bag 26 connected to tube 48, tube 51 connected to platelet collection bag 26, and tube 51 And a bag 28 connected to the. The air bag 27b and the intermediate bag 27a are integrally formed (integrated).

[0024] The first line 21 includes a blood collection needle side first line 21a to which a blood collection needle 29 is connected, one end side connected to the blood collection needle side first line 21a, and the other end side to the inlet of the centrifuge 20 143 and a centrifuge side first line 21b connected to 143. As the blood collection needle 29, for example, a known metal needle is used.

[0025] The blood collection needle-side first line 21a, the centrifuge-side first line 21b, the second line 22 and the third line 23, which will be described later, are each a soft resin tube or its soft It is formed by connecting a plurality of grease tubes!

[0026] The blood collection needle side first line 21a is connected from the blood collection needle 29 side to a branch connector 21c for connection to the third line 23, a chamber 21d for removing bubbles and microaggregates, and a tube. And a first pump tube 21g formed between the chamber 21d and the branch connector 21f.

In addition, bubble sensors 35, 36, and 32 are installed along the blood collection needle side first line 21a from the blood collection needle 29 side. In this case, the bubble sensors 35 and 36 are disposed between the branch connector 21c and the chamber 21d, and the bubble sensor 32 is disposed between the chamber 21d and the first pump tube 2lg.

[0028] The bubble sensors 35, 36, and 32 transmit and receive ultrasonic waves as well as the external force of the tube, and utilize the difference in ultrasonic conductivity between the liquid and bubbles (gas). This is a detection means capable of detecting (separation of gas Z liquid, gas Z liquid level, etc.). The bubble sensors 31, 33 and 34 are detection means having the same function as described above. Further, the bubble sensor (gas and liquid detection means) is not limited to the ultrasonic sensor, and for example, an optical sensor or an infrared sensor may be used.

[0029] Further, a breathable and bacteria-impermeable filter 21i is connected to the chamber 21d via a tube 2lh. This line can be used, for example, for detecting the internal pressure of the blood collection needle side first line 21a. On the other hand, the centrifuge-side first line 21b is connected to a branch connector 21f for connection with the tube 50.

The second line 22 has one end connected to the outlet 144 of the centrifuge 20.

The second line 22 includes a branch connector 22b for connection to the tubes 42 and 43.

In addition, a turbidity sensor 14 and a bubble sensor 34 are installed along the second line 22 from the centrifuge 20 side. In this case, the turbidity sensor 14 and the bubble sensor 34 are disposed between the centrifugal separator 20 and the branch connector 22b.

[0033] Further, a breathable and bacteria-impermeable filter 22f is connected to the branch connector 22b via a tube 41. This line can be used, for example, for detecting the internal pressure of the second line 22.

The third line 23 has one end connected to a connection branch connector 2 lc provided on the first line 21. That is, the third line (flow path) 23 branches from the first line (flow path) 21 via the branch connector (branch portion) 21c. Further, the branch connector 21c is located near the blood collection needle 29 (provided).

[0035] The third line 23 is connected from the branch connector 21c side to the third pump tube 23a, the sterilization filter (foreign matter removal filter) 23b, the bubble removal chamber 23c, and the anticoagulant container. Roll with needle 23d.

In addition, a bubble sensor 31 is installed along the third line 23. The bubble sensor 31 is disposed between the branch connector 21c and the third pump tube 23a.

[0037] The anticoagulant container connecting needle 23d of the third line 23 is connected to a container (not shown) in which an anticoagulant (anticoagulant liquid) is stored (contained), thereby As will be described later, the anticoagulant flows through the third line 23 from the anticoagulant container connecting needle 23d toward the branch connector 21c and is supplied (injected) to the blood collection needle side first line 21a. Thereby, for example, the anticoagulant can be added (mixed) to the blood collected by the blood collection needle 29 via the third line 23.

[0038] The anticoagulant is not particularly limited. For example, an ACD-A solution or the like can be used. [0039] The plasma collection bag 25, which is a blood component collection bag, is a container for collecting (reserving) plasma (plasma component) (second blood component). One end of the tube 49 is connected to the plasma collection bag 25, and a connecting branch connector 22d is provided in the middle thereof. One end of the tube 50 is connected to the branch connector 22d, and the other end is connected to the branch connector 21f. The second pump tube 22a is located between the plasma collection bag 25 and the branch connector 22d. The main parts of the plasma circulation line 24 are constituted by the tubes 49 and 50 and the branch connector 22d.

[0040] One end of the tube 43 is connected to the branch connector 22b, and the other end is provided with a connection branch connector 22c. One end of the tube 44 is connected to the branch connector 22c, and the other end is connected to the plasma collection bag 25.

In addition, a bubble sensor 33 is installed in the middle of the tube 46 along the tube 46.

[0042] A plasma collection branch line for collecting plasma is constituted by the plasma collection bag 25 and tubes 43 and 44.

[0043] Platelet (platelet preparation) collection bag 26, which is a blood component collection bag, is a platelet (platelet component) (blood cell component) containing plasma after passing white blood cell removal filter 261 described later (first blood component) It is a container for collecting (storage). In the following description, platelets containing plasma (first blood component) are referred to as “thick platelets”, and concentrated platelets collected (stored) in the platelet collection bag 26 are referred to as “platelet preparations”. .

[0044] One end of the tube 51 is connected to the platelet collection bag 26, and the bag 28 is connected to the other end.

[0045] The air bag 27b is a container for temporarily storing (storing) air.

[0046] At the time of blood collection to be described later, the air (sterilized air) in the blood component collection circuit 2 such as in the blood storage space 146 of the centrifuge 20 is transferred and stored in the airbag 27b. In the blood return process (blood component return process), the air stored in the airbag 27b is transferred into the blood storage space 146 of the centrifuge 20 and returned. As a result, a predetermined blood component is returned to the donor. [0047] One end of the tube 42 is connected to the branch connector 22b, and the other end is connected to the airbag 27b.

[0048] An intermediate bag (temporary storage bag) 27a, which is a blood component collection bag, is a container for temporarily storing concentrated platelets, that is, platelets containing blood (blood cell component) (first blood component). (Reservoir). One end of the tube 45 is connected to the branch connector 22c, and the other end is connected to the intermediate bag 27a.

[0049] One end of the tube 46 is connected to the intermediate bag 27a, and a connecting branch connector 22e is provided at the other end. The other end of the tube 49 is connected to the branch connector 22e.

[0050] In addition, one end of a tube 47 is connected to the branch connector 22e for connection, and in the middle of the tube 47, a leukocyte removal filter (cell separation) that separates and removes leukocytes (predetermined cells) from the concentrated platelets. Filter) (filter) 261 is installed.

[0051] Further, a branch connector 22g for connection is provided at the other end of the tube 47, and the other end of the tube 48 having one end connected to the platelet collection bag 26 is connected to the branch connector 22g. ing.

[0052] In addition, a filter single body provided with a vent filter and a filter 22h including a cap are installed at the port of the branch connector 22g.

[0053] Here, in a filtration operation or the like for separating and removing leukocytes in the concentrated platelets described later, tubes 46 and 47 constitute a supply tube for supplying the concentrated platelets from the intermediate bag 27a to the leukocyte removal filter 261. Tube 48 is also equipped with leukocyte removal filter 2

Construct a discharge tube that discharges concentrated platelets after separating and removing leukocytes from 61 (supplied to platelet collection bag 26).

[0054] That is, the tubes 46, 47, 48, the intermediate bag 27a, the leukocyte removal filter 261, and the platelet collection bag 26 constitute a filtration line for separating and removing concentrated platelet-powered leukocytes.

[0055] With the blood component collection device 1 assembled (when using the blood component collection device 1), these intermediate bag 27a, leukocyte removal filter 261, platelet collection bag 26, and plasma collection bag 25 are: In each case, the middle nog 27a is lower than the plasma collection bag 25 ( The leukocyte removal filter 261 is set at a position lower than the intermediate bag 27a and the platelet collection bag 26 is set at a position lower than the leukocyte removal filter 261 (positioned vertically). Then, the intermediate nog 27a and the plasma collection bag 25 are respectively positioned higher (upward in the vertical direction) than the blood storage space 146 of the rotor 142 of the centrifuge 20.

[0056] In this case, the blood component collection device 1 is provided with a hanger (hook) force (not shown) that is a support part that detachably supports the plasma collection bag 25, the intermediate bag 27a, and the air bag 27b. Yes. Then, each of the plasma collection bag 25 and the intermediate bag 27a is hooked and hung (suspended) on the corresponding hanger so that the outlet side (inlet side) is vertically downward.

[0057] Further, as the leukocyte removal filter 261, for example, in a casing having an inlet and an outlet at both ends, for example, a woven fabric, a nonwoven fabric, a mesh, and a synthetic resin such as polypropylene, polyester, polyurethane, polyamide, etc. A material formed by inserting a filtration member in which one layer or two or more layers of a porous material such as foam is laminated can be used.

[0058] Constituent materials of the tubes used for forming the first to third lines 21 to 23, the pump tubes 21g, 22a, 23a, and the other tubes 41-51, 21h are as follows. Each of them is preferably a polysalt gel.

[0059] If these tubes are made of poly salt bulbu, sufficient flexibility and softness can be obtained, so that they are easy to handle and suitable for clogging with a clamp or the like.

[0060] Further, as the constituent materials of the above-described branch connectors 21c, 21f, 22b, 22c, 22d, 22e, and 22g, the same constituent materials as those mentioned for the tube can be used.

[0061] The pump tubes 21g, 22a, and 23a have strengths that do not cause damage even when pressed by the respective liquid feeding pumps (for example, roller pumps) 11, 12, and 13, which will be described later. What is provided is used.

[0062] Each of the plasma collection bag 25, the platelet collection bag 26, the intermediate bag 27a, the air bag 27b, and the nod 28 is laminated with a flexible sheet material made of greaves, and its peripheral portion is fused ( Heat-sealed, high-frequency fused, ultrasonic fused, etc.) or a bag formed by bonding with an adhesive is used. As described above, the air bag 27b and the intermediate bag 27a are integrated with each other. Are formed (integrated).

[0063] As a material used for each of the bags 25, 26, 27a, 27b, 28, for example, soft polyvinyl chloride vinyl is preferably used.

[0064] As the sheet material used for the platelet collection bag 26, it is more preferable to use a material having excellent gas permeability in order to improve platelet storage stability.

[0065] As such a sheet material, for example, polyolefin, DnDP plasticized polychlorinated butyl chloride, or the like is used, and a sheet material of the above-described material without using such a material is used. A comparatively thin film (for example, about 0.1 to 0.5 mm, particularly about 0.1 to 0.3 mm) is preferable.

[0066] The main part of such a blood component collection circuit 2 is, for example, a cassette type although not shown. That is, the blood component collection circuit 2 partially stores each line (first line 21, second line 22, third line 23) and each predetermined tube and partially holds them. In other words, it has a cassette housing in which they are partially fixed.

[0067] Both ends of the first pump tube 21g, both ends of the second pump tube 22a, and both ends of the third pump tube 23a are fixed to the cassette housing. The pump tubes 21g, 22a, 23a are Each protrudes from the cassette housing in a loop shape corresponding to the shape of each liquid feed pump (eg, roller pump, etc.) 11, 12, 13. Therefore, the first, second and third pump tubes 21g, 22a and 23a can be easily attached to the liquid feeding pumps 11, 12, and 13, respectively. The cassette housing is provided with respective flow path opening / closing means 81 to 86 described later.

[0068] The centrifuge 20 provided in the blood component collection circuit 2 is generally called a centrifuge bowl, and separates blood into a plurality of blood components by centrifugal force.

[0069] As shown in FIG. 2, the centrifuge 20 has a vertically extending pipe body 141 with an inlet 143 formed at the upper end, and rotates around the pipe body 141 so as to be liquid-tight with respect to the upper part 145. And a sealed hollow rotor 142.

[0070] An annular blood storage space 146 is formed in the rotor 142 along the inner surface of the peripheral wall. The blood storage space 146 is shaped so that the inner and outer diameters of the lower force in FIG. The lower part communicates with the lower end opening of the tube body 141 through a substantially disc-shaped channel formed along the bottom of the rotor 142, and the upper part is the discharge port. (Outflow) Communicate with 144. Further, in the rotor 142, the volume of the blood storage space 146 is, for example, about 100 to 350 mL, and the maximum inner diameter (maximum radius) from the rotating shaft of the rotor 142 is, for example, about 55 to 65 mm.

[0071] Such a rotor 142 rotates under predetermined centrifugal conditions (rotation speed and rotation time) set in advance by the centrifuge drive device 10 included in the blood component collection device 1. Under this centrifugal condition, the blood separation pattern (for example, the number of blood components to be separated) in the rotor 142 can be set.

In this embodiment, as shown in FIG. 2, the centrifugation conditions are set so that the blood is separated into the plasma layer 131, the buffy coat layer 132, and the red blood cell layer 133 from the inner layer in the blood storage space 146 of the rotor 142. Is done.

Next, the overall configuration of the blood component collection device 1 shown in FIG. 1 will be described.

The blood component collection device 1 includes a centrifuge drive device 10 for rotating the rotor 142 of the centrifuge 20, a first liquid feed pump 11 installed in the middle of the first line 21, and a tube. 49, a second liquid pump 12 installed in the middle of 49, a third liquid pump 13 installed in the middle of the third line 23, and a blood component collection circuit 2 (first line 21, tube 42 Tube 44, Tube 45, Tube 47, Tube 49) Multiple channel opening / closing means 81, 82, 83, 84, 85, 86 that can be opened and closed in the middle of the channel. Display means (notification means) and display / operation unit 17 which is an operation means for performing each operation, storage unit (storage unit) 18, centrifuge drive device 10, first liquid feed pump 11, second control unit Liquid feed pump 12, third liquid feed pump 13, a plurality of flow path opening / closing means 81 to 86, display 'operation section 17 and storage section 18 etc. Controller for controlling the part and a (control means) 3.

[0074] Furthermore, blood component collection device 1 includes turbidity sensor 14 installed (installed) in second line 22, optical sensor 15 installed in the vicinity of centrifuge 20, and a plurality of bubble sensors. 31 to 36 and a weight sensor 16 for measuring the weight of the plasma together with the plasma collection bag 25.

[0075] The control unit 3 includes a first liquid feed pump 11, a second liquid feed pump 12, and a third liquid feed pump 1 3 and 3 pump controllers (not shown), the control unit 3 and the first liquid pump 11, the second liquid pump 12 and the third liquid pump 13 are connected via the pump controller. Electrically connected.

A drive controller (not shown) included in the centrifuge drive device 10 is electrically connected to the control unit 3.

[0077] Each flow path opening / closing means 81 to 86 is electrically connected to the control unit 3, respectively.

The turbidity sensor 14, the optical sensor 15, the weight sensor 16, the bubble sensors 31 to 36, the display / operation unit 17, and the storage unit 18 are electrically connected to the control unit 3.

The control unit 3 is composed of, for example, a microcomputer (including a calculation unit and a memory). The control unit 3 includes the turbidity sensor 14, the optical sensor 15, the weight sensor 16, and the bubble. Detection signals from the sensors 31 to 36 are input as needed. A signal (input) from the display / operation unit 17 is also input to the control unit 3.

[0079] The control unit 3 is a program set in advance based on the detection signal from the turbidity sensor 14, the optical sensor 15, the weight sensor 16, the bubble sensor 31 to 36 and the signal from the display / operation unit 17. The operation of each part of the blood component collection device 1, that is, the rotation, stop, and rotation direction (forward rotation Z reverse rotation) of each liquid pump 11, 11, 2, and 13 are controlled as necessary. Control of the opening and closing of the means 81 to 86, the operation of the centrifuge drive device 10 and the drive of the display operation unit 17 are performed.

[0080] The first flow path opening / closing means 81 opens and closes the first line 21 from the first pump tube 21g to the blood collection needle 29 side, that is, between the first pump tube 21g and the chamber 21d. It is provided for.

The second channel opening / closing means 82 is provided for opening and closing the tube 47. The third flow path opening / closing means 83 is provided for opening and closing the tube 44. The fourth flow path opening / closing means 84 is provided for opening and closing the tube 45. The fifth flow path opening / closing means 85 is provided for opening and closing the tube 42. The sixth channel opening / closing means 86 is provided to open and close the tube 49 between the branch connector 22d and the branch connector 22e.

[0082] Each flow path opening / closing means 81 to 86 includes a first line 21, tubes 47, 44, 45, 42, respectively. 49 can be inserted, and the insertion portion has a clamp that is operated by a drive source such as a solenoid, an electric motor, a cylinder (hydraulic pressure or air pressure), for example. Specifically, an electromagnetic clamp operated by a solenoid is preferable.

[0083] These flow path opening / closing means (clamps) 81 to 86 operate based on signals from the control unit 3, respectively.

The display / operation unit 17 includes, for example, a touch panel including a liquid crystal display panel, an EL display panel, and the like. The display / operation unit 17 constitutes an input means for inputting predetermined information and data (for example, an initial value of the target number of blood platelets (blood cell components) to be collected, a blood count of a donor (blood donor), etc.). The

[0085] It should be noted that a display unit (for example, a liquid crystal display panel, an EL display panel, etc.) that is a display unit (notification unit) for displaying (notifying) various types of information, and an operation unit (eg, a liquid crystal display panel, an EL display panel). For example, an operation button, an operation switch, an operation dial, etc.) may be provided separately.

[0086] Further, the storage unit 18 has a storage medium (also referred to as a recording medium) in which various information, data, tables, arithmetic expressions, programs, and the like are stored (also referred to as recording). For example, volatile memory such as RAM, non-volatile memory such as ROM, rewritable (erasable and rewritable) non-volatile memory such as EPROM, EEPRO M, flash memory, etc. Is done. Control such as writing (storing), rewriting, erasing, and reading in the storage unit 18 is performed by the control unit 3.

As shown in FIG. 2, the centrifuge drive device 10 holds a housing 201 that houses the centrifuge 20, a leg 202, a motor 203 that is a drive source, and the centrifuge 20 It has a disk-shaped fixed base 205.

The housing 201 is placed on and fixed to the upper part of the leg portion 202. A motor 203 is fixed to the lower surface of the housing 201 by a bolt 206 via a spacer 207.

A fixed base 205 is fitted on the tip of the rotating shaft 204 of the motor 203 so as to be coaxial with the rotating shaft 204 and rotate integrally therewith. A recess is formed in which the bottom is fitted.

[0090] The upper portion 145 of the centrifuge 20 is attached to the housing 201 by a fixing member (not shown). It is fixed.

In such a centrifuge drive device 10, when the motor 203 is driven, the fixed base 205 and the rotor 142 fixed thereto are rotated at, for example, about 3000 to 6000 rpm.

The housing 201 is provided with an optical sensor 15 on its side (left side in FIG. 2).

The optical sensor 15 is configured to project light toward the blood storage space 146 and receive the reflected light.

The optical sensor 15 irradiates (projects) light (for example, laser light) from the light projecting unit 151, and the reflected light reflected by the reflecting surface 147 of the rotor 142 is received by the light receiving unit 152. Then, the light receiving unit 152 converts the received light amount into an electrical signal.

Here, the optical sensor 15 has a reflection surface on one side and a reflection plate 153 that changes the optical path, and the light emitted from the light projecting unit 151 passes through the reflection plate 153. The light that is incident on the reflection surface 147 and reflected by the reflection surface 147 is received by the light receiving unit 152 via the reflection plate 153.

At this time, the projected light and the reflected light are transmitted through the blood component in the blood storage space 146, respectively, but the blood component interface (in this embodiment, the interface between the plasma layer 131 and the buffy coat layer 132). Depending on the position of B), since the abundance ratio of each blood component at the position where the projected light and the reflected light are transmitted differs, the transmittance thereof changes. As a result, the amount of light received by the light receiving unit 152 varies (changes), and this variation can be detected as a change in the output voltage from the light receiving unit 152.

That is, the optical sensor 15 can detect the position of the blood component interface based on the change in the amount of light received by the light receiving unit 152.

Note that the interface of blood components detected by the optical sensor 15 is not limited to the interface B, and may be, for example, the interface between the buffy coat layer 132 and the red blood cell layer 133.

Here, each of the layers 131 to 133 in the blood storage space 146 has a different color depending on the blood component, and in particular, the red blood cell layer 133 is red with the color of the red blood cells. For this reason, from the viewpoint of improving the accuracy of the optical sensor 15, there is a suitable range for the wavelength of the projection light, The wavelength range is not particularly limited, but is preferably about 600 to 900 nm, and more preferably about 750 to 800 nm.

[0100] The turbidity sensor 14 is for detecting the turbidity (platelet concentration) of the fluid flowing in the second line 22, and outputs a voltage value corresponding to the turbidity. Specifically, the turbidity sensor 14

When the turbidity is high, a low voltage value is output. When the turbidity is low, a high voltage value is output.

[0101] With this turbidity sensor 14, for example, the concentration of platelets in plasma flowing in the second line 22

Can detect changes in platelet concentration in plasma, contamination of red blood cells in plasma, etc.

In addition, the bubble sensor 34 can detect, for example, the replacement of the aerodynamic force of the fluid flowing through the second line 22 with plasma.

[0103] As the turbidity sensor 14 and the bubble sensors 31 to 36, for example, an ultrasonic sensor, an optical sensor, an infrared sensor, or the like can be used.

[0104] The first liquid delivery pump 11 to which the first pump tube 21g is attached, the second liquid delivery pump 12 to which the second pump tube 22a is attached, and the third pump tube 23a are attached. As the third liquid feeding pump 13, for example, a non-blood contact type pump such as a roller pump is preferably used.

[0105] Further, as the first liquid feeding pump (blood pump) 11, a pump capable of feeding blood in any direction is used. Specifically, a roller pump capable of forward and reverse rotation is used.

[0106] By the operation of the first liquid feeding pump 11, for example, liquid (fluid) such as blood and blood components in the first line 21 can be fed (transferred). Further, by the operation of the second liquid feeding pump 12, for example, plasma (liquid) collected in the plasma collection bag 25 can be sent (transferred). Further, by the operation of the third liquid feeding pump 13, for example, a liquid (fluid) such as an anticoagulant (anticoagulant liquid) in the third line 23 can be fed (transferred).

[0107] Here, as will be described later, the blood component collection device 1 includes a first plasma collection step of collecting plasma in the plasma collection bag 25 by the operation of the first liquid feed pump 11, and a second supply of blood. The first constant-speed plasma circulation process (plasma circulation process) in which the plasma collected in the plasma collection bag 25 is circulated in the blood storage space 14 6 of the centrifuge 20 by the operation of the liquid pump 12; Pump 11 The second plasma collection step for collecting plasma in the plasma collection bag 25 by the operation of the second and the second blood collection pump 12 for circulating the plasma collected in the plasma collection bag 25 in the blood storage space 146 by the operation of the second liquid pump 12. 2 constant-speed plasma circulation process (plasma circulation process), the third plasma collection process to collect plasma in the plasma collection bag 25 by the operation of the first liquid pump 11, and the platelet collection process (blood component collection) And a blood platelet collection operation (blood component collection operation) having a blood return process (blood component return process) are executed under the control of the control unit 3 (see FIG. 5).

[0108] In the first constant-speed plasma circulation step and the second constant-speed plasma circulation step, respectively, a plasma circulation line 24, the main part of which is composed of a tube 49, a branch connector 22d and a tube 50, is branched. Connector 21f, centrifuge side first line 21b, centrifuge 20 blood reservoir space 146, second line 22, branch connector 22b, tube 43, branch connector one 22c, tube 44 Then, a circulation circuit is formed (configured) with the plasma collection bag 25, and the operation of the second liquid feeding pump 12 causes the circulation circuit (to pass through the blood storage space 146) to operate the plasma in the plasma collection bag 25. It is going to circulate.

[0109] The first plasma collection step, the second plasma collection step, the third plasma collection step, the first plasma circulation step, and the second plasma circulation step are performed before the platelet collection step. The In addition, the first constant-speed plasma circulation step is executed between the first plasma collection step and the second plasma collection step, and the second constant-speed plasma circulation step is performed in the second plasma collection step. And the third plasma collection step. This platelet collection operation is performed at least once (cycle).

FIG. 5 is a diagram for explaining the characteristics (operation) of the blood component collection device shown in FIG. 1, and FIG. 6 shows the operation control of the second liquid feeding pump of the blood component collection device shown in FIG. FIG. 7 is a diagram for explaining another operation control of the second liquid feeding pump of the blood component collection device shown in FIG.

5, FIG. 6, and FIG. 7, the horizontal axis represents time, and the vertical axis represents the flow rate of the liquid (fluid) introduced into the blood storage space 146 of the centrifuge 20.

Further, the solid line in FIGS. 5, 6 and 7 indicates the liquid (fluid) introduced into the blood storage space 146 of the centrifugal separator 20 by the operation of the first liquid feeding pump 11, that is, Blood (with anticoagulant Blood flow). Of the partial force shown by the diagonal lines, the flow rate of the blood cell component is the flow rate of the blood component, and the part without the diagonal line is the flow rate of the liquid component, that is, plasma (anticoagulant-added plasma).

[0113] Further, the broken line (dotted line) in FIGS. 5, 6, and 7 indicates the liquid component introduced into the blood storage space 146 of the centrifuge 20 by the operation of the second liquid feeding pump 12, that is, The flow rate of plasma (plasma supplemented with anticoagulant). In other words, the flow rate indicated by the broken line indicates that the plasma collected in the plasma collection bag 25 is moved into the blood storage space 146 of the centrifuge 20 via the plasma circulation line 24 or the like by the operation of the second liquid feeding pump 12. This is the plasma flow rate (circulation flow rate) when circulating.

[0114] As shown in FIG. 5, the blood component collection device 1 is used when the first plasma collection process power shifts to the first constant-speed plasma circulation process and the second plasma collection process to the second constant measurement. When shifting to the fast plasma circulation step, the liquid feed amount (discharge amount) of the second liquid feed pump 12 is increased while the operation of the first liquid feed pump 11 is continued. . Thus, in the first constant-speed plasma circulation process and the second constant-speed plasma circulation process, the plasma collected in the plasma collection bag 25 is collected while the plasma is collected in the plasma collection nog 25, respectively. The flow rate of the liquid component introduced into the blood storage space 146 in the blood plasma collection process is changed to the flow rate of the liquid component introduced into the blood storage space 146 of the centrifuge 20 through the Make it bigger. The liquid component includes not only separated plasma but also unseparated blood plasma, anticoagulant (anticoagulant solution), and the like.

In this way, while the first pump 11 is operated and the blood collection process for collecting plasma in the plasma collection bag 25 is being performed, the second liquid delivery pump 12 is operated without interrupting the blood collection process. It operates to perform a plasma circulation process (in this embodiment, a plurality of plasma circulation processes). That is, in each of the first plasma collection process, the second plasma collection process, the third plasma collection process, the first plasma circulation process, and the second plasma circulation process, the first liquid feeding pump 11 The blood is collected from the donor, the blood is introduced into the blood storage space 146 of the centrifuge 20 and separated, and the plasma is collected in the plasma collection bag 25, whereby the plasma in the plasma collection bag 25 is collected. Since blood sampling is continuously performed, blood collection time can be shortened. As a result, the occupation time of the blood component collection device 1 can be reduced, and the burden on the donor can be reduced. It can be done.

[0115] In addition, each of the transition from the first plasma collection step to the first constant-speed plasma circulation step and the transition from the second plasma collection step to the second constant-speed plasma circulation step, respectively. In the plasma collection step, the flow rate of the liquid component introduced into the blood storage space 146 in each constant-speed plasma circulation step (plasma circulation flow rate) is increased in the plasma collection step! Since the flow rate of the liquid component introduced into the blood storage space 146 (the circulating flow rate of plasma) is increased, the platelets trapped by the separated red blood cell layer can be washed out reliably, and the buffy coat An excessive increase in the internal viscosity of the layer (excessive concentration of the puffy coat layer) can be prevented (blocked), thereby improving the recovery rate (yield) of platelets.

In addition, as shown in FIG. 5, in the present embodiment, the second liquid feeding pump 12 operates in each of the first plasma collection step, the second plasma collection step, and the third plasma collection step. The plasma collected in the plasma collection bag 25 is circulated in the blood storage space 146 of the centrifuge 20 via the plasma circulation line 24 or the like. Thereby, the recovery rate of platelets can be further improved.

[0117] In the first plasma collection step of the first cycle, after a predetermined amount (for example, about 10 to 50 mL) of plasma is collected in the plasma collection bag 25, the second liquid feeding pump 12 is activated. The circulation of the plasma collected in the plasma collection bag 25 is started, and FIG. 5 shows the case of the first cycle.

[0118] However, when the target amount of plasma collected in the plasma collection bag 25 is less than the predetermined amount, the plasma is not circulated and is performed when the amount is not less than the predetermined amount.

[0119] In addition, the rotation speed (number of rotations) of the first liquid delivery pump 11 depends on the first plasma collection step, the first plasma circulation step, the second plasma collection step, the second plasma circulation step, It is preferably substantially constant throughout the three plasma collection steps. That is, it is preferable that the flow rate of the blood cell component introduced into the blood storage space 146 of the centrifuge 20 (flowing through the first line 21) by the operation of the first liquid feeding pump 11 is substantially constant.

[0120] In addition, the flow rate of the liquid component introduced into the blood storage space 146 of the centrifuge 20 in each plasma collection step is preferably about 30 to 150 mLZmin, and preferably about 40 to 135 mLZM. Is more preferred. [0121] The amount of liquid fed by the second liquid feed pump 12 in each plasma collection step (circulation flow rate of plasma) is preferably about 0 to 125 mLZmin, and preferably about 5 to 105 mLZmin. More preferred.

[0122] The flow rate of the liquid component introduced into the blood storage space 146 in the first plasma collection step, the flow rate of the liquid component introduced into the blood storage space 146 in the second plasma collection step, and the third flow rate It is preferable that the flow rate of the liquid component introduced into the blood storage space 146 in the plasma collection step is substantially the same.

[0123] Further, the flow rate of the liquid component introduced into the blood storage space 146 of the centrifuge 20 in each constant-speed plasma circulation step is a force depending on the rotational speed of the centrifuge 20 and the blood collection speed, respectively. It is preferably about 250 mLZmin, more preferably about 60 to 200 mLZmin.

[0124] This prevents platelets from flowing out from the outlet 144 of the centrifuge 20, and allows the platelets that are trapped by the separated red blood cell layer to be washed out reliably and buffy coat. An excessive increase in the internal viscosity of the layer can be prevented, and the recovery rate of platelets can be improved.

[0125] Further, the flow rate of the liquid component introduced into the blood storage space 146 of the centrifuge 20 in each constant-speed plasma circulation step and the flow rate of the liquid component introduced into the blood storage space 146 in each plasma collection step The difference, that is, the increase in the liquid supply volume (plasma circulation flow rate) of each second liquid supply pump 12 when moving from each plasma collection process to each constant-speed plasma circulation process is about 10 to 20 mLZmin. It is preferable that it is about 60 to 200 mLZmin.

[0126] This prevents platelets from flowing out from the outlet 144 of the centrifuge 20, and allows the platelets that are trapped by the separated red blood cell layer to be reliably washed out, and buffy coat An excessive increase in the internal viscosity of the layer can be prevented, and the recovery rate of platelets can be improved.

[0127] The flow rate of the liquid component introduced into the blood storage space 146 in the second constant-speed plasma circulation step is the flow rate of the liquid component introduced into the blood storage space 146 in the first constant-speed plasma circulation step. Less (smaller) is preferred than the amount. [0128] Specifically, the flow rate of the liquid component introduced into the blood storage space 146 in the first constant-speed plasma circulation step is preferably about 100 to 250 mLZmin, and is about 120 to 200 mLZmin. Is more preferable.

[0129] The flow rate of the liquid component introduced into the blood storage space 146 in the second constant-speed plasma circulation step is preferably about 40 to 200 mLZmin, more preferably about 60 to 175 mLZmin. .

[0130] Further, the flow rate of the liquid component introduced into the blood storage space 146 in the first constant-speed plasma circulation process and the blood flow introduced into the blood storage space 146 in the first plasma collection process, which is the plasma collection process immediately before the blood flow. That is, the flow rate of the second liquid pump 12 during the transition to the first constant-speed plasma circulation process from the power of the first plasma collection process (the circulating flow rate of plasma) ) Is preferably about 60 to 220 mLZmin, more preferably about 80 to 180 mLZmin.

[0131] Further, the flow rate of the liquid component introduced into the blood storage space 146 in the second constant-speed plasma circulation step, and the blood flow introduced into the blood storage space 146 in the second plasma collection step, which is the immediately preceding plasma collection step. That is, the flow rate of the second liquid pump 12 during the transition to the second constant-speed plasma circulation process from the power of the second plasma collection process (the plasma circulation flow rate) ) Is preferably about 15 to 150 mLZmin, more preferably 70 to about LOOmLZmin.

Further, as shown in FIG. 6, the blood component collection device 1 includes a first plasma collection step, a second plasma collection step, a third plasma collection step, a first plasma circulation step, and a second plasma collection step. In each of the plasma circulation processes, the second liquid feed pump 12 is operated so that the flow rate of the liquid component introduced into the blood storage space 146 of the centrifuge 20 becomes a predetermined target value (a constant value). It is configured to control and adjust the liquid feeding amount of the second liquid feeding pump 12! RU

[0133] That is, when the flow rate of blood collected from the donor (blood collection speed) decreases, the rotational speed of the first liquid delivery pump 11 is decreased accordingly. As shown in Fig. 2, when the blood collection volume decreases during the period T and the flow rate of blood (blood cell component and liquid component) introduced into the blood storage space 146 of the centrifuge 20 decreases, the second liquid delivery pump 12 The amount of liquid delivered, i.e. collected in the plasma collection bag 25. By increasing the circulation flow rate of the plasma (liquid component), the flow rate of the liquid component introduced into the blood storage space 146 is increased so that a2 = al.

Accordingly, it is possible to prevent the blood collection volume 146 from excessively centrifuging due to a decrease in the amount of collected blood, thereby reducing the platelet recovery rate.

[0135] The target value (constant value) can be set and changed by the operator operating the display / operation unit 17. For example, the donor's hematocrit value can be calculated. The target value can be appropriately changed according to the above.

[0136] In each plasma collection step, plasma circulation by the operation of the second liquid feeding pump 12 may not be performed. That is, the liquid feed amount of the second liquid feed pump 12 may be configured to increase from 0 when moving from each plasma collection step to each constant-speed plasma circulation step.

[0137] Further, in each plasma collection step, the liquidity introduced into the blood storage space 146 of the centrifuge 20 even when plasma circulation by the operation of the second liquid feeding pump 12 is not performed. It may be configured to perform adjustment (control) for setting the flow rate of the component to a predetermined target value (a constant value). That is, as shown in FIG. 7, the blood component collection device 1 includes a first plasma collection step, a second plasma collection step, a third plasma collection step, a first plasma circulation step, and a second plasma circulation step. In each of these, the operation of the second liquid delivery pump 12 is controlled so that the flow rate of the liquid component introduced into the blood storage space 146 of the centrifuge 20 becomes a predetermined target value (a constant value). The liquid feeding pump 12 may be configured to adjust the liquid feeding amount.

For example, as shown in FIG. 7, during the period T, the blood flow (blood collection speed) collected from the donor decreases, and the blood (blood cell components and blood) introduced into the blood storage space 146 of the centrifuge 20 decreases. When the flow rate of the liquid component (and the liquid component) decreases, the second liquid pump 12 is operated to circulate the plasma (liquid component) collected in the plasma collection bag 25 into the blood storage space 146, thereby storing the blood. Increase the flow rate of the liquid component introduced into the space 146 so that b2 = bl.

[0139] The number of plasma collection steps in each cycle is not limited to 3 times, and may be, for example, 1 time, 2 times, or 4 times or more.

[0140] The number of constant-speed plasma circulation steps in each cycle is not limited to two. For example, it may be 1 time or 3 times or more.

[0141] In addition, the plasma circulation process is not limited to constant-speed plasma circulation in which plasma is circulated at a constant flow rate (speed). May be.

[0142] Meanwhile, "1 unit" of platelets, 0.5 a 2 X 10 ¹¹ cells, and as the platelet products (defined in Formulation Standard Ru ones), the following (1) to (4) There are four types.

[0143] (1) 5-unit preparation

The volume (volume) is 100mL ± 20%, and the number power 1. OX IO ¹¹ ! ^ 9 X 10 ¹¹

(2) 10 unit preparation

The volume (volume) is 200mL ± 20%, and the number is 2. 0 X 10 ¹¹ to 2. 9 X 10 ¹¹

(3) 15 unit preparation

The capacity (volume) is 250mL ± 20% and the number is 3. Ο Χ Ιθ '^ Β. 9 X 10 ¹¹

(4) 20 unit preparation

The volume (volume) is 250mL ± 20% and the number is 4.0 X 10 ¹¹ or more

[0144] Next, the action (operation) of blood component collection device 1, that is, the platelet collection operation (blood component collection operation) using blood component collection device 1 is shown in the flow charts shown in Figs. The explanation will be made with reference to FIG.

[0145] In this embodiment, the blood component collection device 1 repeats the platelet collection operation (blood component collection operation) a plurality of times (1st cycle to nth cycle, n is 2 or more) under the control of the control unit 3. Integer). This platelet collection operation will be described in detail later.

[0146] In parallel with the final cycle of platelet collection operation, or after the final cycle of platelet collection operation, blood component collection device 1 is controlled by control unit 3 in intermediate bag 27a. Concentrated platelets temporarily collected (stored) are supplied to the leukocyte removal filter 261, and the platelets are filtered, that is, a filtration operation (filtration process) is performed to separate and remove leukocytes in the concentrated platelets. RU

In this filtering operation, the second flow path opening / closing means 82 is opened. As a result, the concentrated platelets in the intermediate bag 27a are transferred into the platelet collection bag 26 via the tubes 46, 47, the leukocyte removal filter 261, and the tube 48 due to a drop (self-weight). At this time, rich Most of the platelets are force passing through the filtration member of the leukocyte removal filter 261. White blood cells are captured by the filtration member. For this reason, the removal rate of leukocytes in the platelet preparation can be made extremely high.

[0148] The timing of starting this filtration operation is not particularly limited, but from the viewpoint of shortening the donor's restraint time, this filtration operation is performed at the same time as the platelet collection operation in the final cycle (in particular, the platelet collection operation is performed earlier). It is preferred to start (in a step process). In the blood component collection device 1 of the present embodiment, the filtration operation is started almost simultaneously with the start of the second plasma collection step in the platelet collection operation in the final cycle (for example, before step S 105 in FIG. 3). However, in the flowcharts shown in FIGS. 3 and 4, the description of the step of the filtration operation start (filtration process start) is omitted.

[0149] It should be noted that the transport of concentrated platelets to the intermediate bag 27a internal force platelet collection bag 26 may be carried out using a pump.

[0150] [0] First, the blood collection needle 29 of the third line 23 and the first line 21 to the chamber 21d are primed with an anticoagulant, and then into the blood vessels of the donor (donor). Puncture blood collection needle 29.

[I] The first cycle of platelet collection (see Fig. 3 and Fig. 4)

[II] First, the blood component collection device 1 performs the first plasma collection step. In the first plasma collection step, blood is introduced into the blood storage space 146 of the rotor 142, and the plasma (PPP) separated by centrifuging the blood is collected in the plasma collection bag 25.

[0151] In the first plasma collection step, first, the control unit 3 collects plasma (step S101 in Fig. 3).

[0152] Specifically, the first flow path opening / closing means 81 and the fifth flow path opening / closing means 85 are opened and the other flow path opening / closing means are closed under the control of the control unit 3. One donor pump 11 is operated (forward rotation) at a predetermined rotation speed (preferably about 250 mLZmin or less, more preferably about 40 to 150 mLZmin, for example, 60 mLZmin), and donor force starts blood collection.

[0153] Simultaneously with this blood collection, the third liquid feed pump 13 is operated under the control of the control unit 3, and an anticoagulant such as ACD-A liquid is applied via the third line 23, for example. Supply and mix this anticoagulant into the blood sample. [0154] At this time, the rotation speed of the third liquid feeding pump 13 is such that the control unit 3 mixes the anticoagulant with the blood sample at a predetermined ratio (preferably about 1Z20 to 1Z6, for example, 1Z10). Controlled.

As a result, blood (blood added with an anticoagulant) is transferred via the first line 21 and introduced into the blood storage space 146 of the rotor 142 through the tube body 141 from the inlet 143 of the centrifuge 20. Is done.

[0156] At this time, the air in the centrifuge 20 (sterilized air) passes through the second line 22 and the tube 4

2 is sent into the air bag 27b.

[0157] Further, at the same time as or before and after the blood collection, the control unit 3 is provided with a centrifuge drive device.

10 is operated and the rotor 142 is controlled to rotate at a predetermined rotational speed.

[0158] The blood introduced into the blood storage space 146 by the rotation of the rotor 142 causes the plasma layer (PPP layer) 131, the buffy coat layer (BC layer) 132, and the red blood cell layer (CRC layer) 133 from the inside. Separated into three layers.

[0159] The rotational speed of the rotor 142 is preferably about 3000 to 6000 rpm, and more preferably about 4200 to 5800 rpm. In the following steps, the control unit 3 does not change the rotational speed of the rotor 142 unless otherwise specified.

[0160] Furthermore, when the blood collection and the supply of the anticoagulant are continued and blood (approximately 270 mL) exceeding the capacity of the blood storage space 146 is introduced into the blood storage space 146, the blood storage space 146 is filled with blood. Filled and plasma (PPP) flows out from the outlet 144 of the centrifuge 20.

[0161] At this time, the bubble sensor 34 installed in the second line 22 detects that the fluid flowing in the second line 22 has changed to aerodynamic plasma, and the control unit 3 Based on the detection signal 34, control is performed so that the fifth flow path opening / closing means 85 is closed and the third flow path opening / closing means 83 is opened.

[0162] This introduces and collects plasma into the plasma collection bag 25 via the second line 22, tubes 43 and 44.

Note that the weight of the plasma collection bag 25 is measured by the weight sensor 16, and the measured weight signal is input to the control unit 3.

[0164] Based on the information (weight signal) from the weight sensor 16, the control unit 3 It is determined whether or not a predetermined amount (preferably about 10 to 50 g, for example, 30 g) of plasma is collected, and if a predetermined amount of plasma is collected in the plasma collection bag 25, the plasma collection bag 25 The plasma inside is circulated through the blood storage space 146 at a constant speed.

Specifically, under the control of the control unit 3, the second liquid feeding pump 12 is operated (forward rotation) at a predetermined rotational speed (preferably about 5 to 105 mLZmin, for example, 55 mLZmin).

As a result, the plasma in the plasma collection bag 25 is introduced into the blood storage space 146 through the plasma circulation line 24 and the first line 21 at a constant speed, and flows out from the outlet 144 of the centrifuge 20. The collected plasma is collected into the plasma collection bag 25 via the second line 22, tubes 43 and 44. That is, the plasma in the plasma collection bag 25 is circulated in the blood storage space 146 at a constant speed.

[0167] Next, the control unit 3 determines whether or not a predetermined amount of plasma has been collected in the plasma collection bag 25 based on information (weight signal) from the weight sensor 16 (step of FIG. 3). S102).

[0168] The amount of plasma collected (predetermined amount) is preferably about 10 to 50 g, more preferably about 20 to 40 g.

[0169] In step S102, when a predetermined amount of plasma is not collected in plasma collection bag 25, control unit 3 returns to step S101, and repeats step S101 and subsequent steps again.

[0170] If a predetermined amount of plasma is collected in the plasma collection bag 25 in step S102, the control unit 3 ends this step [11] (first plasma collection step), Move to the first constant-speed plasma circulation process.

[0171] [12] Next, blood component collection apparatus 1 performs a first constant-speed plasma circulation step. In the first constant-speed plasma circulation process, blood is introduced into the blood storage space 146 of the rotor 142, and the operation of collecting the plasma separated by centrifuging the blood into the plasma collection bag 25 is continued. The circulation rate (circulation amount) of plasma into the blood storage space 146 is also increased during the first plasma collection process, and the plasma in the plasma collection bag 25 is circulated at a constant speed through the blood storage space 146. The

[0172] In the first constant-speed plasma circulation process, the control unit 3 collects the plasma into the collection bag 25, and moves to the first constant-speed plasma circulation process from the first plasma collection process. 2 pumps Increase (change) the rotational speed of step 12 to circulate plasma (step S103 in FIG. 3).

Specifically, under the control of the control unit 3, the rotational speed of the second liquid feeding pump 12 is increased to a predetermined rotational speed (preferably about 55 to 225 mLZmin, for example, 165 mLZmin), and the second liquid feeding pump 12 is increased. Operate fluid pump 12 (forward rotation).

[0174] Next, the control unit 3 starts the first constant-speed plasma circulation for a predetermined time (preferably 10

It is determined whether or not about 90 seconds (for example, 30 seconds) has elapsed (step S104 in FIG. 3).

[0175] If the predetermined time has not elapsed since the start of the first constant-velocity plasma circulation in step S104, the control unit 3 returns to step S103 and repeats step S103 and subsequent steps again.

[0176] Also, in step S104, if a predetermined time has elapsed since the start of the first constant-speed plasma circulation, the control unit 3 performs this step [12] (first constant-speed plasma circulation step ) And move to the second plasma collection step.

[13] [13] Next, blood component collection apparatus 1 performs a second plasma collection step. In the second plasma collection step, the circulation rate of the plasma into the blood storage space 146 is made lower than that in the first constant-speed plasma circulation step, and the plasma in the plasma collection bag 25 is passed through the blood storage space 146. While continuing the operation of circulating at high speed, blood is introduced into the blood storage space 146 of the rotor 142, and plasma separated by centrifugal separation of the blood is collected in the plasma collection bag 25.

[0178] In the second plasma collection step, instead of measuring the amount of plasma collected by the weight sensor 16, the position of the interface B between the plasma layer 131 and the buffy coat layer 132 is detected. Except for the completion, the same steps as in the above-mentioned step [11] (first plasma collecting step) are performed.

[0179] In the second plasma collection step, the control unit 3 collects the plasma in the collection bag 25 and moves the second plasma collection step from the first constant-speed plasma circulation step to the second plasma collection step. Plasma is circulated by reducing (changing) the rotation speed of the liquid feed pump 12 (step S105 in FIG. 3).

As a result, as the amount of red blood cells in the blood storage space 146 increases, that is, as the layer thickness of the red blood cell layer 133 increases, the interface B also gradually moves in the direction of the rotation axis of the rotor 142.

[0181] Next, the control unit 3 determines whether or not the interface B has reached a predetermined level (first position) based on the detection signal (interface position detection information) from the optical sensor 15 (Fig. 1). 3 steps S106).

[0182] The first position of the interface B is the position at which the detection signal from the first optical sensor 15 (output voltage from the light receiving unit 152) force is preferably about 1 to 2V. It is said.

In step S106, when interface B has not reached the first position, control unit 3 returns to step S105, and repeats step S105 and subsequent steps again.

[0184] In step S106, when the interface B reaches the first position, the control unit 3 ends this step [13] (second plasma collection step) and performs the second determination. Move to fast plasma circulation process.

[14] [14] Next, blood component collection apparatus 1 performs a second constant-speed plasma circulation step. In the second constant speed plasma circulation process, blood is introduced into the blood storage space 146 of the rotor 142, and the operation of collecting the plasma separated by centrifuging the blood into the plasma collection bag 25 is continued. Then, the circulation rate of the plasma into the blood storage space 146 is made larger than that in the second plasma collection step, and the plasma in the plasma collection bag 25 is circulated through the blood storage space 146 at a constant speed.

[0186] In the second constant-speed plasma circulation step, the control unit 3 collects the plasma into the collection bag 25, and moves to the second constant-speed plasma circulation step from the second plasma collection step. Circulating the plasma by increasing (changing) the rotational speed of the second liquid delivery pump 12 (step S10 7 in FIG. 3).

Specifically, under the control of the control unit 3, the rotation speed of the second liquid feeding pump 12 is increased to a predetermined rotation speed (preferably about 10 to 175 mLZmin, for example, 85 mLZmin), and the second feeding pump 12 Operate fluid pump 12 (forward rotation).

[0188] Next, the control unit 3 starts a second constant-speed plasma circulation for a predetermined time (preferably 10

It is determined whether or not about 90 seconds (for example, 30 seconds) has elapsed (step S108 in FIG. 3).

[0189] In step S108, if the predetermined time has not elapsed since the start of the second constant-velocity plasma circulation, the control unit 3 returns to step S107, and repeats step S107 and subsequent steps again.

[0190] In addition, in step S108, when a predetermined time has elapsed since the start of the second constant-speed plasma circulation, the control unit 3 performs this process [14] (second constant-speed plasma circulation process). ) And move to the third plasma collection step. [0191] [15] Next, the blood component collection device 1 performs a third plasma collection step. In the third plasma collection step, the circulation rate of the plasma into the blood storage space 146 is made lower than that in the second constant-speed plasma circulation step, and the plasma in the plasma collection bag 25 is passed through the blood storage space 146 to be determined. While continuing the operation of circulating at high speed, blood is introduced into the blood storage space 146 of the rotor 142, and plasma separated by centrifugal separation of the blood is collected in the plasma collection bag 25.

[0192] Next, the control unit 3 determines whether or not the predetermined amount of plasma is collected in the plasma collection bag 25 based on the amount and the number of rotations of the first liquid pump 11 per rotation. (Step S110 in FIG. 3).

[0193] The amount of plasma collected (predetermined amount) is preferably about 2 to 30 g, more preferably about 5 to 15 g.

[0194] When a predetermined amount of plasma is collected in the plasma collection bag 25 in step S110, the control unit 3 ends this step [15] (third plasma collection step), Move to platelet collection process (shift to 1 in Fig. 4).

[16] Next, blood component collection apparatus 1 performs a platelet collection step. In the platelet collection process, the collection of plasma in the collection bag 25 is interrupted, and the plasma in the plasma collection bag 25 is circulated in the blood storage space 146 while being accelerated at the first acceleration, and then the first collection is performed. The acceleration is changed to the second acceleration, and is circulated while accelerating at the second acceleration. The platelets are discharged from the blood storage space 146, and the concentrated platelets are collected (stored) in the intermediate bag 27a. ))

[0196] In the platelet collection step, first, the control unit 3 stops collecting plasma into the collection bag 25 and performs plasma circulation by the first acceleration (step S111 in Fig. 4).

Specifically, under the control of the control unit 3, the first flow path opening / closing means 81 is closed, the first liquid feed pump 11 and the third liquid feed pump 13 are stopped, and the second The liquid feed pump 12 is operated (forward rotation) so that its rotational speed increases (increases) at the first acceleration.

[0198] As a result, the blood collection is interrupted, and the plasma in the plasma collection bag 25 is introduced into the blood storage space 146 through the plasma circulation line 24 and the first line 21 while being accelerated at the first acceleration. Then, the plasma flowing out from the outlet 144 of the centrifuge 20 is collected in the plasma collection bag 25 through the second line 22 and the tubes 43 and 44. That is, plasma collection The plasma in the collection bag 25 is circulated in the blood storage space 146 while being accelerated at the first acceleration.

[0199] At this time, if the plasma is circulated in the blood storage space 146 while accelerating at the first acceleration, the red blood cell layer 133 diffuses (increase in the layer thickness), and the interface B gradually turns into the rotation axis of the rotor 142. Move in the direction.

[0200] The first acceleration is preferably 0.5 to: about LOmLZminZsec, more preferably

1. About 5 to 2.5 mLZminZsec. The first acceleration need not be constant.

For example, it may change stepwise or continuously within the above range.

[0201] Further, the initial speed of the first liquid delivery pump 11 in the plasma circulation by the first acceleration is preferably about 40 to 150 mLZmin, more preferably about 50 to 80 mLZmin.

[0202] Next, the control unit 3 continues Step S111 until the circulating speed of plasma into the blood storage space 146 reaches a predetermined speed (Step S112 in FIG. 4).

[0203] The predetermined speed, that is, the rotation speed of the first liquid delivery pump 11 when the plasma circulation by the first acceleration is completed is preferably about 100 to 180 mLZmin, more preferably 140 to 160 mLZmin. It is said to be about.

[0204] In step S112, when the circulation speed of plasma into blood storage space 146 reaches a predetermined speed, control unit 3 performs plasma circulation by the second acceleration (step of FIG. 4). S 113).

Specifically, under the control of the control unit 3, the acceleration of the second liquid feeding pump 12 is changed from the first acceleration to the second acceleration, and the second liquid feeding pump 12 is It operates (forward rotation) so that its rotation speed increases tl (increase) at the second acceleration. As a result, the plasma in the plasma collection bag 25 is circulated in the blood storage space 146 while being accelerated at the second acceleration.

[0206] At this time, if plasma is circulated in the blood storage space 146 while accelerating at the second acceleration, diffusion of the red blood cell layer 133 (increase in the layer thickness) occurs, and the interface B gradually becomes the rotation axis of the rotor 142. In addition to moving in the direction, the platelets in the buffy coat layer 132 rise against the centrifugal force (float up) and move toward the discharge port 144 of the rotor 142.

[0207] The second acceleration is set to be larger than the first acceleration, preferably about 3 to 20 mLZminZsec, more preferably about 5 to: LOmLZminZsec. The first The acceleration of 2 may not be constant. For example, it may change stepwise or continuously within the above range.

[0208] Next, the control unit 3 determines whether or not the circulating speed of plasma into the blood storage space 146 has reached a predetermined speed, that is, the rotational speed of the first liquid feeding pump 11 is a predetermined speed (preferably 120 to It is determined whether or not 3 OOmLZmin (eg, 250mLZmin) has been reached (step S114 in Fig. 4).

[0209] In step S114, if the circulation speed of plasma into blood storage space 146 has not reached the predetermined speed, control unit 3 returns to step S113 and repeats step S113 and subsequent steps again.

[0210] In step S114, when the circulation speed of plasma into blood storage space 146 reaches a predetermined speed, control unit 3 continues the plasma circulation (step S115 in FIG. 4).

[0211] Specifically, the control unit 3 controls to maintain (hold) the rotational speed of the second liquid feeding pump 12 at the predetermined speed in step S114. Thereby, the circulation rate of plasma into the blood storage space 146 is preferably about 120 to 300 mLZmin, for example, 250 mLZmin.

[0212] Next, the control unit 3 starts step S115 and determines whether or not a predetermined time (preferably about 5 to 15 seconds, for example, 10 seconds) has passed (step S116 in FIG. 4).

[0213] In step S116, if a predetermined time has passed since the start of step S115! / ヽ !!, then control unit 3 outputs the output voltage from turbidity sensor 14. It is determined whether or not the power (PC concentration voltage) has dropped below a predetermined value (preferably about 2.5 to 3.5 V, for example, 3. OV) (step S 117 in FIG. 4).

[0214] If the output voltage from the turbidity sensor 14 has not decreased below the predetermined value in step S117, the control unit 3 returns to step S115 and repeats step S115 and subsequent steps again.

[0215] While repeating steps S115 to S117, in step S116, when step S115 is started and the force has also passed for a predetermined time, the control unit 3 performs this step [16] (platelet collection step). And the process proceeds to step S122 described later.

[0216] In step S117, the output voltage of 14 turbidity sensors is as low as the predetermined value. If the platelet concentration in the plasma flowing in the second line 22 reaches a predetermined value or more as platelets flow out from the outlet 144 of the rotor 142, the control unit 3 collects platelets (PC) (step S 118 in FIG. 4).

Specifically, based on the detection signal of the turbidity sensor 14, the control unit 3 closes the third flow path opening / closing means 83 and opens the fourth flow path opening / closing means 84. Control.

[0218] Thus, concentrated platelets are introduced into the intermediate bag 27a via the second line 22, tubes 43 and 45, and collected (stored). At this time, since the second flow path opening / closing means 82 is closed, concentrated platelets do not flow out from the intermediate bag 27a.

[0219] Further, the control unit 3 calculates the platelet concentration (cumulative PC concentration) in the intermediate bag 27a based on the output voltage (detection signal) from the turbidity sensor 14. The platelet concentration continues to increase after starting to collect platelets, and once it reaches the maximum concentration, it begins to decrease.

[0220] Next, the control unit 3 determines whether or not a predetermined time (preferably about 10 to 25 seconds, for example, 15 seconds) has elapsed since the start of platelet collection (step S119 in FIG. 4).

[0221] In step S119, when the predetermined time has passed since the start of platelet collection, the control unit 3 then outputs the output voltage (PC concentration) of the turbidity sensor 14. It is determined whether or not the voltage has reached a predetermined value or less (step S120 in FIG. 4).

[0222] The predetermined value of the output voltage of the turbidity sensor 14 is a value near the time when red blood cells are mixed in the plasma flowing through the second line 22, and is preferably about 0.5 V or less.

[0223] In step S120, if the output voltage of the turbidity sensor 14 has not reached the predetermined value or less, the control unit 3 then determines whether or not the concentrated platelets in the intermediate bag 27a have reached the predetermined amount. (Step S121 in FIG. 4).

[0224] The collection amount (predetermined amount) of the concentrated platelets is preferably about 20 to about LOOmL, and more preferably about 30 to 80mL.

[0225] If the platelet concentrate in the intermediate bag 27a does not reach the predetermined amount in step S121, the control unit 3 returns to step S118 and repeats step S118 and subsequent steps again.

[0226] While the steps S118 to S121 are repeated, in step S119, when the collection of platelets starts and the force has also passed for a predetermined time, or in step S120, the turbidity When the output voltage of the degree sensor 14 reaches a predetermined value or less, the control unit 3 ends this step [16] (platelet collection step), and proceeds to step S122 described later.

[0227] If a predetermined time has elapsed in steps S116 and S119, if the output voltage (PC concentration voltage) of the turbidity sensor 14 is equal to or lower than a predetermined value in step S120, intermediate in step S121. When the concentrated platelets in the bag 27a reach a predetermined amount, the control unit 3 opens the fifth channel opening / closing means 85 and blocks all other channel opening / closing means 81 to 84, 86. In this state, the second liquid feeding pump 12 is stopped, and this step [16] (platelet collecting step) is completed.

[0228] [17] Next, blood component collection apparatus 1 performs a step of stopping centrifuge 20.

In this process, first, the control unit 3 decelerates the centrifuge 20 (step S122 in FIG. 4).

[0229] Specifically, the number of rotations of the centrifuge drive device 10 is reduced by the control of the control unit 3.

, Slow down the rotor 142.

Further, the control unit 3 stops the centrifuge 20 (step S123 in FIG. 4).

Specifically, under the control of the control unit 3, the rotation of the centrifuge drive device 10 is stopped and the rotor 142 is stopped.

[18] [18] Next, blood component collection apparatus 1 performs a blood return step. Rotor in the blood return process 1

Blood components (remaining blood components) in 42 blood storage spaces 146 are returned.

In the blood return process, the control unit 3 performs blood return (step S124 in FIG. 4).

[0232] Specifically, the first flow path opening / closing means 81 and the fifth flow path opening / closing means 85 are opened under the control of the control unit 3, and the first liquid feed pump 11 is set to a predetermined rotational speed. (Preferably 2

Operates (reverses) at 0 to 120mLZmin (eg 90mLZmin).

[0233] As a result, blood components (mainly red blood cells and white blood cells) remaining in the blood storage space 146 of the rotor 142 are discharged from the inlet 143 of the centrifuge 20, and the first line 21 (blood collection needle 29) Blood is returned (returned) to the donor.

[0234] Then, after the air discharged from the centrifugal separator 20 is detected by the bubble sensor 32 and the first liquid feed pump 11 is rotated a predetermined number of times, the first flow path opening / closing means 81 and The flow path opening / closing means 85 of FIG. 5 is closed, and the first liquid feeding pump 11 is stopped, and this process [1 8] End (blood return process).

This completes the first cycle of platelet collection.

[2] Platelet collection operation in the second cycle that is not the final cycle (see FIGS. 3 and 4) Subsequently, the platelet collection operation in the second cycle is performed.

[0236] In the second-cycle platelet collection operation, the same steps as in the first-cycle platelet collection operation are performed as follows.

[21] to [28] Steps similar to the above steps [11] to [18] are performed, respectively.

This completes the second cycle of platelet collection.

The same applies to the platelet collection operation after the third cycle, but not the last cycle.

[0238] [3] Platelet collection operation in the final cycle (see Figure 3 and Figure 4)

Subsequently, the platelet collection operation for the final cycle is performed.

[0239] In the platelet collection operation in the final cycle, a filtration operation (filtration process) for separating and removing white blood cells from concentrated platelets is performed, and air discharged from the centrifuge 20 is detected by the bubble sensor 32 when returning blood. Then, if air is further detected by the bubble sensor 35 or 36, the same process as the platelet collection operation in the first cycle is performed except that the blood return process is terminated.

[0240] [31] to [37] Steps similar to those in the steps [11] to [17] are performed except that the filtration operation is performed.

[0241] [38] Air discharged from the centrifuge 20 is detected by the bubble sensor 35 or 36, and the first flow path opening / closing means 81 and the fifth flow path opening / closing means 85 are closed, and the first The step similar to the above step [18] is performed except that the liquid feeding pump 11 is stopped and this step [38] (blood return step) is ended.

Thereby, the platelet collection operation in the final cycle is completed.

[0242] The platelet collection operation is not limited to being performed a plurality of times, and may be performed only once, for example.

[0243] The configuration of blood component collection circuit 2 can also be set as appropriate, and is not limited to the illustrated configuration.

[0244] As described above, according to this blood component collection device, the first plasma circulation step including only the first plasma collection step, the second plasma collection step, and the third plasma collection step, and Even in the second plasma circulation step, the first liquid delivery pump 11 operates, blood is collected from the donor, and the blood is introduced into the blood storage space 146 of the centrifuge 20 and separated to collect plasma. Since plasma is collected in bag 25, the blood collection time can be shortened. Thereby, the occupation time of the blood component collection apparatus 1 can be reduced, and the burden on the donor can be reduced.

[0245] Also, each of the transition from the first plasma collection process to the first constant-speed plasma circulation process, and the transition from the second plasma collection process to the second constant-speed plasma circulation process, respectively. In the plasma collection step, the flow rate of the liquid component introduced into the blood storage space 146 in each constant-speed plasma circulation step (plasma circulation flow rate) is increased in the plasma collection step! Since the flow rate of the liquid component introduced into the blood storage space 146 (the circulating flow rate of plasma) is increased, the platelets trapped by the separated red blood cell layer can be washed out reliably, and buffy coat An excessive increase in the internal viscosity of the layer (excessive concentration of the puffy coat layer) can be prevented (blocked), thereby improving the recovery rate (yield) of platelets.

[0246] The blood component collection device of the present invention has been described based on the illustrated embodiment. However, the present invention is not limited to this, and the configuration of each part is of any configuration having the same function. Can be substituted. In addition, the present invention may include other arbitrary components and processes.

[0247] Furthermore, the blood component collection device of the present invention is not limited to the application to obtain both platelet preparations and plasma preparations (or the raw material plasma of plasma fractionation preparations), but only platelet preparations from blood. You may apply when you get.

[0248] Further, the blood component collection device of the present invention is not limited to the case where it is applied to obtain a platelet preparation or a plasma preparation, but is applied, for example, to obtain an erythrocyte preparation, a leukocyte preparation, etc. from blood. May be. That is, in the blood component collection device of the present invention, the blood cell component collected in the blood component collection bag is not limited to platelets (platelets including plasma), but, for example, red blood cells (red blood cells including plasma), white blood cells (including plasma) White blood cells).

[0249] In the present invention, the blood separator is not limited to a centrifugal type, and may be, for example, a membrane type.

[0250] In the present invention, the cells separated and removed by the cell separation filter (filter) are also white blood. Not limited to spheres.

In the present invention, the optical sensor is not limited to the illustrated one, and may be a line sensor or the like, for example.

[0252] The method of the blood component collection device of the present invention is not limited to the intermittent type, and may be, for example, a continuous type. Moreover, the thing without a blood return process may be sufficient.

Industrial applicability

[0253] According to the present invention, the flow rate of the liquid component introduced into the blood separator is made relatively large, that is, the plasma circulation step is set to be larger than the flow rate in the plasma collection step. Therefore, for example, blood cell components (for example, platelets) to be collected that are confined by the separated erythrocyte layer can be reliably washed out. Thereby, the recovery rate of the blood cell component can be improved. In the plasma circulation process, blood from the donor is collected and the plasma is collected in the plasma collection bag, so that the blood collection time can be shortened. Thereby, the occupation time of the blood component collection device can be reduced, and the burden on the blood donor can be reduced. Therefore, it has industrial applicability.

Claims

The scope of the claims

[1] Blood collection means equipped with a hollow needle for collecting blood from a donor,

A blood separator for separating blood collected by the blood collecting means;

A plasma collection bag for collecting plasma separated by the blood separator;

When shifting from the plasma collection step to the plasma circulation step, the amount of liquid fed by the second liquid feeding unit is increased while continuing the operation of the first liquid feeding unit, thereby the plasma circulation step. In this case, while collecting plasma in the plasma collection bag, the plasma collected in the plasma collection bag is circulated to the blood separator via a plasma circulation line, and the liquid introduced into the blood separator A blood component collecting apparatus, wherein the flow rate of the sex component is configured to be larger than the flow rate of the liquid component introduced into the blood separator in the plasma collecting step.

[2] The blood component collection device according to claim 1, wherein the flow rate of the liquid component introduced into the blood separator in the plasma circulation step is 40 to 250 mLZmin.

[3] The flow rate of the liquid component introduced into the blood separator in the plasma circulation process, The difference from the flow rate of the liquid component introduced into the blood separator in the blood plasma collection step,

2. The liquid component collecting device according to claim 1, which is 10 to 220 mLZmin.

[4] In the plasma collection step, the second liquid feeding means is activated, and the plasma collected in the plasma collection bag is circulated to the blood separator via the plasma circulation line. The blood component collection device according to claim 1, wherein the blood component collection device is configured as described above.

[5] During the plasma collection step, the operation of the second liquid feeding means is controlled so that the flow rate of the liquid component introduced into the blood separator becomes a predetermined target value. 2. The blood component collection device according to claim 1, wherein the blood component collection device is configured to adjust a liquid feeding amount of the second liquid feeding means.

[6] During the plasma circulation step, the operation of the second liquid feeding means is controlled so that the flow rate of the liquid component introduced into the blood separator becomes a predetermined target value. 2. The blood component collection device according to claim 1, wherein the blood component collection device is configured to adjust a liquid feeding amount of the second liquid feeding means.

[7] The plasma collection step is executed a plurality of times before the blood component collection step, and the plasma circulation step is executed between the plasma collection steps. 2. The blood component collection apparatus according to item 1.

[8] The blood component collection device includes the plasma collection step, the plasma circulation step, the blood component collection step, and the blood return step of returning the remaining blood components to the donor. The blood component collection device according to claim 1, wherein the operation is performed for at least one cycle.

[9] The blood component collection device according to [1], wherein the predetermined blood cell component is platelets.