JP4607803B2 - Blood component collection device - Google Patents

Description

  The present invention relates to a blood component collection device.

  When collecting blood, the collected blood is separated into each blood component by centrifugation, etc. for reasons such as effective use of the blood and reduction of the burden on the donor, and only the components necessary for the transfuser are collected. Blood is collected to return to the person.

  In such component blood collection, blood collected from a blood donor is introduced into a blood component collection circuit using a blood component collection device, and plasma is collected by a centrifuge called a centrifuge bowl installed in the blood component collection circuit. The buffy coat and red blood cells are separated, and platelets (platelet containing plasma) are separated from the buffy coat, and the platelets are collected in a platelet collection bag to obtain a platelet preparation, and the plasma is also collected in the plasma collection bag to obtain a plasma preparation or The remaining plasma, white blood cells, and red blood cells are returned to the blood donor as a raw material for the plasma fractionation product (returning step). That is, a blood component collection operation including a step of collecting plasma and platelets (predetermined blood cell components) and a blood return step of returning the remaining blood components to the blood donor is performed for a predetermined cycle.

  In this component blood collection, platelets are temporarily stored in a temporary storage bag, the platelets in the temporary storage bag are supplied to a leukocyte removal filter, leukocytes are separated and removed by the leukocyte removal filter, and collected in a platelet collection bag. A filtration operation for (collecting) is also performed (see, for example, Patent Document 1).

  By the way, the number of cycles of blood component collection operation is, for example, the predicted value of the number of platelets collected in one cycle (the number of platelets collected per cycle) and the target number of units of the formulation standard of platelet products (for platelet products) There are four types of 5 unit preparation, 10 unit preparation, 15 unit preparation, and 20 unit preparation), and the blood sample collection operation is performed for the set number of cycles. However, there are cases where the number of collected platelets does not reach the target number and a platelet preparation that conforms to the target preparation standard cannot be obtained. That is, the platelet count deficiency (unit breakage) may occur with respect to the target formulation standard.

  In such a case, in order to eliminate the platelet count deficiency, the blood component collection operation may be further performed (addition of a cycle) after the blood component collection operation in the final cycle is completed.

  However, once the filtration operation is finished and the temporary storage bag is emptied, air is sent from the temporary storage bag toward the leukocyte removal filter, the inflow side space of the leukocyte removal filter, the leukocyte removal filter and the temporary storage bag, In the conventional blood component collection device, if the filtration operation has already been completed, an air block has occurred in the leukocyte removal filter, and the filtration operation is performed again. Therefore, it was impossible to add a cycle of blood component collection operation.

  In addition, if the platelet count deficiency (unit breakage) cannot be resolved, such as when component blood collection is stopped halfway for some reason, the concentrated blood platelets collected in the platelet collection bag are discarded in the conventional blood component collection device. I had to do it.

JP 10-212237 A

  An object of the present invention is to provide a blood component collection device capable of performing a filtration operation again even after the filtration operation is completed and the temporary storage bag is emptied. Another object of the present invention is to provide a blood component collection device capable of transferring concentrated platelets (PC) collected in a platelet collection bag to a plasma collection bag.

Such an object is achieved by the present inventions (1) to ( 8 ) below.
(1) Blood collection means for collecting blood from a donor,
A blood separator that separates blood collected by the blood collection means into a plurality of blood components;
A plasma collection bag for collecting plasma separated by the blood separator;
A temporary storage bag for temporarily storing a predetermined blood cell component separated by the blood separator;
A cell separation filter for separating and removing predetermined cells from the predetermined blood cell component;
A blood component collection bag for collecting the predetermined blood cell component after passing through the cell separation filter;
A filtration line for transferring the predetermined blood cell component from the temporary storage bag to the blood component collection bag through the cell separation filter;
A blood component collection circuit comprising a liquid supply line branched from a branch portion provided between the temporary storage bag and the cell separation filter in the filtration line, and connected to the plasma collection bag;
Liquid feeding means installed in the liquid feeding line ;
A controller for controlling the operation of the liquid feeding means ,
The controller supplies the predetermined blood cell component from the temporary storage bag to the cell separation filter, separates and removes the predetermined cell by the cell separation filter, and collects the blood cell in the blood component collection bag. After the execution, the liquid feeding means is operated, and the predetermined blood cell component collected in the blood component collection bag or the predetermined blood cell component collected in the blood component collection bag and the plasma collected in the plasma collection bag A blood component collection apparatus characterized by performing a refilling operation of sending liquid to the filtration line and removing air in the filtration line.

(2) In the refilling operation, the control unit operates the liquid feeding means to feed a predetermined blood cell component collected in the blood component collection bag to the branching unit, and the filtration line A first step of removing air between the cell separation filter and the branch part and the cell separation filter;
The control unit operates the liquid feeding means to transfer the plasma collected in the plasma collection bag to the temporary storage bag via the transfer line, and the branching unit and the temporary in the filtration line. blood component collection apparatus according to (1) to perform the second step of removing the air between the reservoir bag.

(3) the re-filling operation, after the first step is completed, the blood component collection apparatus according to (2) to perform the second step.

(4) The control unit operates the liquid feeding unit to collect the predetermined blood cell component from the temporary storage bag to the plasma collection bag via the filtration line and the transfer line. blood component collection apparatus according to any one of the above (1) to perform the operation (3).

(5) The control unit operates the liquid feeding means to collect the predetermined blood cell component from the blood component collection bag to the plasma collection bag via the filtration line and the transfer line. The blood component collection device according to any one of (1) to (4), wherein a transfer operation is performed.

  (6) When using the blood component collection device, the blood component collection bag is provided such that the flow path side communicating with the cell separation filter is vertically downward (1) to (5) The blood component collection device according to any one of the above.

(7) the filtration operation, the fall of the predetermined blood cell components, the was fed into the cell separation filter from the temporary reservoir bag, the upper SL via the cell separation filter you transferred to said blood component collection bag (1) The blood component collection device according to any one of (6).

  (8) The blood component collecting apparatus according to any one of (1) to (7), wherein the predetermined blood cell component is a thick platelet.

  According to the present invention, since the air in the filtration line (the flow path between the cell separation filter and the temporary storage bag in the filtration line and the air accumulated in the cell separation filter) can be removed, the filtration operation is completed. Thus, even if the temporary storage bag becomes empty, the filtration operation can be performed again. That is, even when the filtration operation is finished and the temporary storage bag is emptied, a blood component collection operation cycle is added, the blood component collection operation is executed, and the blood cell components temporarily stored in the temporary storage bag ( For example, platelets may be supplied to a cell separation filter (for example, a leukocyte removal filter), and predetermined cells (for example, white blood cells) may be separated and removed by the cell separation filter and collected (collected) in a blood component collection bag. it can. Thereby, a blood product (for example, a platelet product) conforming to the product specification can be reliably obtained.

  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. FIG. 2 is a diagram showing a centrifugal separator mounted on the centrifuge drive device provided in the blood component collection device shown in FIG. It is a partially broken sectional view of a state.

  A blood component collection apparatus 1 shown in FIG. 1 separates blood into a plurality of blood components, and separates blood platelets (platelets including plasma) (blood components), which are predetermined blood cell components, and plasma (blood components). It is a device for collecting. The blood component collection device 1 has a rotor 142 having a blood storage space 146 therein, an inlet 143 communicating with the blood storage space 146, and an outlet (outlet) 144. The rotor 142 rotates to rotate the inlet 142 from the inlet 143. A centrifuge (blood separator) 20 that centrifuges the introduced blood in the blood storage space 146, a first line 21 that connects a blood collection needle (blood collection means) 29 and the inlet 143 of the centrifuge 20; 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. And a plasma collection bag (collection bag) 25 connected to the second line 22 via the tubes 43 and 44, and an air connected to the second line 22 via the tube 42. The bag 27b, an intermediate bag (temporary storage bag) (collection bag) 27a connected to the second line 22 via the tubes 43 and 45, and an intermediate bag 27a connected via the tubes 46, 47 and 48 A blood component collection circuit (collection circuit) 2 having a platelet collection bag (collection bag) 26 and a bag 28 connected to the platelet collection bag 26 via a tube 51 is provided.

  Further, the blood component collecting device 1 includes a centrifuge driving device 10 for rotating the rotor 142 of the centrifuge 20, and a first liquid feeding pump (first liquid feeding means) for the first line 21. ) 11, a second liquid feed pump (second liquid feed means) 12 which is a liquid feed means, a third liquid feed pump (third liquid feed means) 13 for the third line 23, and A plurality of (in the present embodiment, first to seventh seven) channel opening / closing means 81, 82, 83, 84, 85, 86, 87 that can open and close the channel of the blood component collection circuit 2; , A control unit (control) for controlling the centrifuge drive device 10, the first liquid feeding pump 11, the second liquid feeding pump 12, the third liquid feeding pump 13, and the plurality of channel opening / closing means 81 to 87. Means) 3, a turbidity sensor (platelet concentration sensor) 14, an optical sensor 15, and a weight sensor 16 A plurality (in this embodiment, six) and a bubble sensor 31,32,33,34,35,36 of.

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

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

  The blood collection needle side first line 21a, the centrifuge side first line 21b, the second line 22 and the third line 23 described later are each connected by a soft resin tube or a plurality of soft resin tubes. Has been formed.

  The blood collection needle side first line 21a is connected to the third line 23 from the blood collection needle 29 side, the chamber 21d for removing bubbles and microaggregates, and the branch connector for connection to the tube 50. (Second branch portion) 21f, and has a first pump tube 21g formed between the chamber 21d and the branch connector 21f.

  Air 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 21g.

  The bubble sensors 35, 36, and 32 transmit and receive ultrasonic waves from the outside of the tube, and make use of the fact that the ultrasonic conductivity differs between the liquid and the bubbles (gas), so that the gas and liquid (gas / liquid) in the tube are used. Or a gas / liquid level). The bubble sensors 31, 33 and 34 are also 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, an infrared sensor, or the like may be used.

  The chamber 21d is connected with a gas-permeable and bacteria-impermeable filter 21i through a tube 21h. This line can be used for detecting the internal pressure of the blood collection needle side first line 21a, for example.

  On the other hand, the centrifuge side first line 21 b is connected to a branch connector 21 f for connection with the tube 50.

One end of the second line 22 is 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.

  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 centrifuge 20 and the branch connector 22b.

  The branch connector 22b is connected with a filter 22f that is air-permeable and bacteria-impermeable through a tube 41. This line can be used for detecting the internal pressure of the second line 22, for example.

  One end of the third line 23 is connected to a connecting branch connector 21 c 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. The branch connector 21c is located (provided) in the vicinity of the blood collection needle 29.

  The third line 23 includes, from the branch connector 21c side, a third pump tube 23a, a sterilizing filter (foreign matter removing filter) 23b, a bubble removing chamber 23c, and an anticoagulant container connecting needle 23d. It has.

  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.

  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 housed (contained), whereby the anticoagulant in the container is As will be described later, the anticoagulant container connecting needle 23d flows through the third line 23 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.

  In addition, although it does not specifically limit as an anticoagulant, For example, ACD-A liquid etc. can be used.

  The plasma collection bag 25 that is a blood component collection bag is a container for collecting (storing) plasma (second blood component). One end of the tube 49 is connected to the plasma collection bag 25, and a connecting branch connector (third branch portion) 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 tube 50 and the branch connectors 21f and 22d constitute the main part of the plasma circulation line 24. That is, one end of the plasma circulation line 24 branches from a branch connector 21f provided on the first line 21 between the first liquid feeding pump 11 and the rotor 142 of the centrifuge 20 and the other end. The side branches from a branch connector 22d provided in a refill line 62 (tube 49) described later between the second liquid feeding pump 12 and the branch connector 22e.

  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.

  A bubble sensor 33 is installed along the tube 46 in the middle of the tube 46.

  The plasma collection bag 25 and tubes 43 and 44 constitute a plasma collection branch line for collecting plasma.

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

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

  The air bag 27b is a container for temporarily storing (reserving) air.

  At the time of blood collection to be described later, 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 air bag 27b. In the blood return process (blood component return process), the air stored in the air bag 27b is transferred into the blood storage space 146 of the centrifuge 20 and returned. Thereby, a predetermined blood component is returned to the donor.

  One end of the tube 42 is connected to the branch connector 22b, and the other end is connected to the airbag 27b.

  The intermediate bag (temporary storage bag) 27a is a container (storage unit) for temporarily storing concentrated platelets, that is, platelets including blood plasma (blood cell component) (first blood component). One end of the tube 45 is connected to the branch connector 22c, and the other end is connected to the intermediate bag 27a.

  One end of the tube 46 is connected to the intermediate bag 27a, and the other end is provided with a connecting branch connector (first branch portion) 22e which is a branch portion. The other end of the tube 49 is connected to the branch connector 22e.

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

  The tube 49 and the branch connector 22e constitute a main part of a refilling line (liquid feeding line) 62. That is, the refilling line 62 has a branch connector 22e provided in a filtration line 61 (described later) between the leukocyte removal filter 261 and the intermediate bag 27a, branches from the branch connector 22e, and enters the plasma collection bag 25. It is connected.

  The other end of the tube 47 is provided with a connecting branch connector 22g, and the other end of the tube 48, one end of which is connected to the platelet collection bag 26, is connected to the branch connector 22g.

  Further, a filter main body provided with a vent filter and a filter 22h provided with a cap are installed at the port of the branch connector 22g.

  Here, in a filtration operation for separating and removing leukocytes in the concentrated platelets described later, the tubes 46 and 47 constitute a supply tube for supplying the concentrated platelets from the intermediate bag 27a to the leukocyte removal filter 261. Constitutes a discharge tube for discharging the concentrated platelets after the white blood cells have been separated and removed from the white blood cell removal filter 261 (supplied to the platelet collection bag 26).

  That is, concentrated platelets (predetermined blood cell components) are passed from the intermediate bag 27a through the leukocyte removal filter 261 by the tubes 46, 47 and 48 and the leukocyte removal filter 261 provided between the tubes 47 and 48. A filtration line 61 is configured to transfer to the platelet collection bag 26 and separate and remove white blood cells from the concentrated platelets (separate and remove predetermined cells from predetermined blood cell components).

  With the blood component collection device 1 assembled (when the blood component collection device 1 is used), the intermediate bag 27a, the leukocyte removal filter 261, the platelet collection bag 26, and the plasma collection bag 25 are respectively the intermediate bag 27a. It is set (positioned) at the highest position in the vertical direction, the leukocyte removal filter 261 is set at a position lower than the intermediate bag 27a (downward in the vertical direction), and the platelet collection bag 26 is set at a position lower than the leukocyte removal filter 261. (To position). The intermediate bag 27a is positioned higher than the blood storage space 146 of the rotor 142 of the centrifuge 20 (upward in the vertical direction), and the plasma collection bag 25 is separated from the blood storage space 146 of the rotor 142 of the centrifuge 20 with the blood storage space 146. Located at approximately the same height. Needless to say, the plasma collection bag 25 may be positioned higher than the blood storage space 146 of the rotor 142 of the centrifuge 20.

  In addition, since the 2nd liquid feeding pump 12 is provided, you may provide the plasma collection bag 25 in the position lower than the intermediate | middle bag 27a.

  In addition, the blood component collection apparatus 1 includes a hanger (hook) (not shown) that is a support unit that detachably supports the plasma collection bag 25, the intermediate bag 27a and the air bag 27b, and the platelet collection bag 26, respectively. Is provided. The plasma collection bag 25, the intermediate bag 27a, and the platelet collection bag 26 are hooked and hung (suspended) on the corresponding hangers so that the outlet side (inlet side) is vertically downward. That is, when the blood component collection device 1 is used, the plasma collection bag 25 is provided so that the tubes 44 and 49 side thereof is vertically downward, and the intermediate bag 27a is provided such that the tubes 45 and 46 side thereof are in the vertical direction. The platelet collection bag 26 is provided so that the tubes 48 and 51 side (the channel side communicating with the leukocyte removal filter 261) are vertically downward. By providing the platelet collection bag 26 so that the tubes 48 and 51 side are vertically downward, the platelet preparation in the platelet collection bag 26 can be easily discharged from the platelet collection bag 26 in a refilling operation to be described later. be able to.

  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, a foam or the like made of a synthetic resin such as polypropylene, polyester, polyurethane, polyamide, etc. The thing constituted by inserting the filtration member which laminated one layer or two layers or more of a porous body can be used.

  As the constituent materials of the tubes used for forming the first to third lines 21 to 23 and the pump tubes 21g, 22a and 23a, and the other tubes 41 to 51 and 21h, respectively, Vinyl chloride is preferred.

  If these tubes are made of polyvinyl chloride, sufficient flexibility and softness can be obtained, so that they are easy to handle and are suitable for clogging with a clamp or the like.

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

  In addition, as each pump tube 21g, 22a, 23a, what has the intensity | strength of the grade which is not damaged even if it presses by each liquid feeding pump (for example, roller pump etc.) 11, 12, 13 mentioned later, respectively is used. Has been.

  Each of the plasma collection bag 25, the platelet collection bag 26, the intermediate bag 27a, the air bag 27b, and the bag 28 is laminated with a resin-made flexible sheet material, and the peripheral portions thereof are fused (thermal fusion, high frequency fusion). Or a bag formed by bonding with an adhesive or the like. As described above, the air bag 27b and the intermediate bag 27a are integrally formed (integrated).

  As a material used for each bag 25, 26, 27a, 27b, 28, for example, soft polyvinyl chloride is preferably used.

  In addition, as a sheet material used for the platelet collection bag 26, it is more preferable to use a material excellent in gas permeability in order to improve platelet storage stability.

  As such a sheet material, for example, polyolefin, DnDP plasticized polyvinyl chloride, or the like is used, and a sheet material of the above-described material is used without using such a material. What was thin (for example, about 0.1-0.5 mm, especially about 0.1-0.3 mm) is suitable.

  Although the main part of such a blood component collection circuit 2 is not shown, it is of a cassette type, for example. That is, the blood component collection circuit 2 includes a cassette housing that partially stores each line and each predetermined tube and partially holds them, in other words, partially fixes them.

  In the cassette housing, 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. These pump tubes 21g, 22a, and 23a are respectively connected to the cassette housing. From the housing, it protrudes in the shape of a loop corresponding to the shape of each liquid feed pump (for example, roller pump etc.) 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 87 described later.

  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.

  As shown in FIG. 2, the centrifuge 20 has a vertically extending tube 141 with an inlet 143 formed at the upper end, and rotates around the tube 141 and is liquid-tightly sealed with respect to the upper portion 145. And a hollow rotor 142.

  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 has a shape (tapered shape) in which the inner and outer diameters gradually decrease from the lower part toward the upper part in FIG. 2, and the lower part is formed in a substantially disc shape formed along the bottom part of the rotor 142. The upper end of the tubular body 141 communicates with the discharge port (outlet) 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.

  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, a blood separation pattern (for example, the number of blood components to be separated) in the rotor 142 can be set.

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

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 driving device 10 for rotating the rotor 142 of the centrifuge 20, a first liquid feeding pump 11 installed in the middle of the first line 21, and a tube 49. The second liquid pump 12 installed in the middle, the third liquid pump 13 installed in the middle of the third line 23, and the blood component collection circuit 2 (first line 21, tube 42, tube 44, tube 45, tube 47, tube 49) and a plurality of channel opening / closing means 81, 82, 83, 84, 85, 86, 87 that can open and close in the middle of the channel, and various information are displayed (notified). A display means (notification means) and a display / operation section 17 which is an operation means for performing each operation, a storage section (storage means) 18, a centrifuge drive device 10, a first liquid feed pump 11, a second feed pump Liquid pump 12, third liquid feed Amplifier 13, a plurality of flow path shutter means 81 to 87, and a control section (control means) 3 for controlling the respective units such as the display and operation unit 17 and the storage unit 18.

  Furthermore, the blood component collection device 1 includes a turbidity sensor 14 mounted (installed) on the second line 22, an optical sensor 15 installed near the 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.

  The control unit 3 includes three pump controllers (not shown) for the first liquid feeding pump 11, the second liquid feeding pump 12, and the third liquid feeding pump 13, and includes the control unit 3 and the first liquid feeding pump 13. The liquid feed pump 11, the second liquid feed pump 12, and the third liquid feed pump 13 are electrically connected via a pump controller.

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

Each of the channel opening / closing means 81 to 87 is electrically connected to the control unit 3.
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 each electrically connected to the control unit 3.

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

  The control unit 3 collects blood components according to a preset program based on the detection signals from the turbidity sensor 14, the optical sensor 15, the weight sensor 16, the bubble sensors 31 to 36 and the signal from the display / operation unit 17. The operation of each part of the apparatus 1, that is, the rotation, stop, and rotation direction (forward / reverse rotation) of each liquid feed pump 11, 12, 13 is controlled, and the flow path opening / closing means 81 to 87 are opened and closed as necessary. The operation of the centrifuge drive device 10 and the drive of the display / operation unit 17 are controlled.

  The first flow path opening / closing means 81 is provided to open and close 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. Yes.

  The second flow path opening / closing means 82 is provided to open / close the tube 47 (the filtration line 61 between the leukocyte removal filter 261 and the branch connector 22e). 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 to open and close the tube 45. The fifth flow path opening / closing means 85 is provided for opening and closing the tube 42. The sixth flow path opening / closing means 86 is provided to open and close the tube 50 between the branch connector 21f and the branch connector 22d. The seventh flow path opening / closing means 87 is provided to open / close the tube 46 (the filtration line 61 between the branch connector 22e and the intermediate bag 27a).

  Each of the channel opening / closing means 81 to 87 includes an insertion portion into which the first line 21 and the tubes 47, 44, 45, 42, 46, and 50 can be inserted. The insertion portion includes, for example, a solenoid, an electric motor It has a clamp that operates with a drive source such as a motor or cylinder (hydraulic or pneumatic). Specifically, an electromagnetic clamp that operates with a solenoid is suitable.

  Each of these channel opening / closing means (clamps) 81 to 87 operates based on a signal from the control unit 3.

  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 input means for inputting predetermined information and data (for example, an initial value of the target number of platelets (blood cell components) to be collected, a blood count of a donor (donor), etc.).

  In addition, 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 information, and an operation unit (for example, an operation button) that is an operation unit for performing each operation. , An operation switch, an operation dial, etc.) may be provided separately.

  The storage unit 18 includes 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 a recording medium). It is composed of various semiconductor memories, IC memories, and the like, such as volatile memories such as RAM, nonvolatile memories such as ROM, rewritable (erasable and rewritable) nonvolatile memories such as EPROM, EEPROM, and flash memory. Control such as writing (storage), 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 includes a housing 201 that houses the centrifuge 20, a leg portion 202, a motor 203 that is a drive source, and a disk-shaped fixing that holds the centrifuge 20. And a table 205.

  The housing 201 is placed and fixed on the upper portion of the leg portion 202. In addition, a motor 203 is fixed to the lower surface of the housing 201 via a spacer 207 with bolts 206.

  A fixed base 205 is fitted on the tip of the rotating shaft 204 of the motor 203 so as to rotate coaxially and integrally with the rotating shaft 204, and the bottom of the rotor 142 is fitted on the upper portion of the fixed base 205. A concave portion is formed.

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

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

  The optical sensor 15 is installed on the side of the housing 201 (left side in FIG. 2).

  The optical sensor 15 is configured to project light toward the blood storage space 146 and to 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. The light receiving unit 152 converts the received light quantity into an electrical signal.

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

  At this time, the projection light and the reflected light are transmitted through the blood component in the blood storage space 146, but the position of the blood component interface (the interface B between the plasma layer 131 and the buffy coat layer 132 in this embodiment). Accordingly, since the abundance ratio of each blood component at a position where the light projection light and the reflected light are transmitted is different, the transmittance thereof is changed. 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.

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

  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 range suitable for the wavelength of the projection light, and the wavelength range is not particularly limited, but is preferably about 600 to 900 nm, for example. 750 to 800 nm is more preferable.

  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 outputs a low voltage value when the turbidity is high and a high voltage value when the turbidity is low.

  The turbidity sensor 14 can detect, for example, the concentration of platelets in plasma flowing through the second line 22, changes in the platelet concentration in plasma, and contamination of red blood cells into the plasma.

  Further, the bubble sensor 34 can detect, for example, the replacement of the fluid flowing in the second line 22 from air to plasma.

  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.

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

  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 rotation and reverse rotation is used.

  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.

  Moreover, as the 2nd liquid feeding pump 12, what can send the blood to any direction is used. Specifically, a roller pump capable of forward rotation and reverse rotation is used.

  By the operation of the second liquid feeding pump 12, for example, the plasma collected in the plasma collection bag 25, the concentrated platelets collected in the intermediate bag 27a, and the platelet preparation collected in the platelet collection bag 26 can be delivered. it can.

  Further, by the operation of the third liquid feed pump 13, for example, a liquid (fluid) such as an anticoagulant (anticoagulant liquid) in the third line 23 can be fed.

  Next, the action (operation) of the blood component collection device 1, that is, the platelet collection operation (blood component collection operation) using the blood component collection device 1 will be described.

  The blood component collection device 1 controls the control unit 3 to perform a first plasma collection step for collecting plasma in the plasma collection bag 25 and the plasma collected in the plasma collection bag 25 in the blood storage space 146 of the centrifuge 20. A constant-velocity plasma circulation step (plasma circulation step) for circulating at a constant speed, a second plasma collection step for collecting plasma in the plasma collection bag 25, and the plasma collected in the plasma collection bag 25 in the centrifuge 20. Accelerated plasma circulation step (plasma circulation step) for circulating while accelerating in the blood storage space 146, a third plasma collection step for collecting plasma in the plasma collection bag 25, and concentrated platelets (platelets) temporarily in the intermediate bag 27a A platelet collecting operation (blood component collecting operation) having a platelet collecting step (collecting) and a blood returning step (blood component returning step) is temporarily stored in the intermediate bag 27a. The concentrated platelets are supplied to the leukocyte removal filter 261, and the filtration of the concentrated platelets, that is, the filtration operation (filtration process) for separating and removing the leukocytes in the concentrated platelets and collecting (collecting) them in the platelet collection bag 26 is executed. And operate to collect blood components.

  At the time of blood sampling, the first liquid pump 11 is operated (forward rotation), blood is collected from the donor via the first line 21, and the third liquid pump 13 is operated, For example, an anticoagulant such as ACD-A solution is supplied through the line 23, and this anticoagulant is mixed (injected) into the collected blood. As a result, blood (anticoagulant-added blood) is transferred through the first line 21 and introduced into the blood storage space 146 of the rotor 142 from the inflow port 143 of the centrifuge 20 via the tube body 141. At this time, the air (sterilized air) in the centrifuge 20 is sent into the air bag 27b through the second line 22 and the tube 42.

  In addition, the centrifuge drive device 10 is operated to rotate the rotor 142 of the centrifuge 20, and blood introduced into the blood storage space 146 is separated from the plasma layer (PPP layer) 131, the buffy coat layer (BC layer) from the inside. ) 132 and the red blood cell layer (CRC layer) 133 is separated into three layers.

  The first plasma collection step, the constant-speed plasma circulation step, the second plasma collection step, the accelerated plasma circulation step, the third plasma collection step, and the platelet collection step are performed in this order. Thus, a predetermined amount of plasma is collected in the plasma collection bag 25, and a predetermined amount and a predetermined number (predetermined number of units) of concentrated platelets are collected (temporarily stored) in the intermediate bag 27a. In addition, blood components remaining in the blood storage space 146 of the rotor 142 of the centrifuge 20 (mainly red blood cells) (mainly red blood cells and white blood cells) are returned to the inlet of the centrifuge 20 by performing the blood return process. The blood is discharged from 143 and returned (returned) to the donor via the first line 21 (blood collection needle 29). In component blood collection, this platelet collection operation (blood component collection operation) is performed at least once (one cycle), and usually a plurality of times (multiple cycles).

  The platelet collection operation can be performed using a method described in, for example, Japanese Patent Application Laid-Open No. 2005-152362, although the circuit configuration is slightly different. In this case, as a main difference, in the present embodiment, in the constant-speed plasma circulation step and the accelerated plasma circulation step, the refill line (liquid feed) is activated by the operation (forward rotation) of the second liquid feed pump 12, respectively. Line) 62 tube 49, branch connector 22d, 21f and tube 50 for plasma circulation (plasma feeding line) 24, centrifuge side first line 21b, centrifuge 20 The blood storage space 146, the second line 22, the branch connector 22b, the tube 43, the branch connector 22c, the tube 44, and the plasma collection bag 25 form (configure) a circulation circuit for the second delivery. The operation of the liquid pump 12 causes the plasma in the plasma collection bag 25 to circulate in the circulation circuit (through the blood storage space 146).

  In the filtering operation, the second flow path opening / closing means 82 and the seventh flow path opening / closing means 87 are opened. Thereby, the concentrated platelets in the intermediate bag 27a are transferred (liquid fed) to the leukocyte removal filter 261 via the tubes 46 and 47 due to a drop (self-weight), and further to the tube 48 via the leukocyte removal filter 261. Then, it is transferred into the platelet collection bag 26. At this time, most of the concentrated platelets pass through the filtration member of the leukocyte removal filter 261, but the leukocytes are captured by the filtration member. For this reason, the removal rate of leukocytes in the platelet preparation can be made extremely high.

  This filtration operation is performed in parallel with the final-cycle platelet collection operation or after the completion of the final-cycle platelet collection operation.

By the way, the number of “one unit” of platelets is 0.2 × 10 ¹¹ , and the following four types (1) to (4) are used as platelet preparations (those defined in the preparation standard). There is.

(1) 5-unit preparation The volume (volume) is 100 mL ± 20%, and the number is 1.0 × 10 ^{11 to} 1.9 × 10 ¹¹

(2) 10-unit preparation The volume (volume) is 200 mL ± 20%, and the number is 2.0 × 10 ^{11 to} 2.9 × 10 ¹¹

(3) 15-unit preparation The volume (volume) is 250 mL ± 20%, and the number is 3.0 × 10 ^{11 to} 3.9 × 10 ¹¹

(4) 20 unit preparation The volume (volume) is 250 mL ± 20%, and the number is 4.0 × 10 ¹¹ or more.

  The blood component collection device 1 operates the second liquid-feeding pump 12 after performing the filtration operation, and the platelet preparation (platelet) collected in the platelet collection bag 26 and the plasma collection bag in the filtration line 61. 25 is fed (transferred) to remove air from the entire filtration line 61 (at least the leukocyte removal filter 261 of the filtration line 61), that is, the air in the entire filtration line 61 is removed from the platelet preparation (platelet) The refilling operation (air removal operation) for replacing with a liquid such as plasma can be executed. Thereby, even if filtration operation is complete | finished and the intermediate | middle bag 27a becomes empty, filtration operation can be performed again.

  In the present embodiment, in the refilling operation, the second liquid feeding pump 12 is operated (reversed), and the platelet preparation (platelets) collected in the platelet collection bag 26 is fed to at least the branch connector 22e. The first step of removing air between the leukocyte removal filter 261 and the branch connector 22e in the filtration line 61 and the leukocyte removal filter 261, and the second flow path opening / closing means 82 are closed, and then the second liquid feeding is performed. The pump 12 is actuated (forward rotation), and the plasma collected in the plasma collection bag 25 is sent to the intermediate bag 27a via the refilling line 62 (via the refill line 62). A second step of removing air between the bag 27a and the bag 27a is performed. Thereby, air can be more reliably removed from the entire filtration line 61.

  In this case, the first step and the second step may be executed first, but the first step is first, that is, the first step is completed. It is preferable that the second step is performed later. Thereby, air can be easily and reliably removed from the entire filtration line 61 without mixing air or platelets into the plasma collection bag 25.

  In addition, the blood component collection device 1 operates (reverses) the second liquid feeding pump 12 to pass the concentrated platelets (platelets) in the intermediate bag 27a via the filtration line 61 and the refilling line 62 (via ) The first transfer operation (transfer operation from the intermediate bag 27a) for collection (collection) in the plasma collection bag 25 can be executed. Thereby, the concentrated platelets in the intermediate bag 27a can be easily and reliably collected in the plasma collection bag 25. For this reason, for example, when platelet collection from the donor is poor, or when collecting blood components for the convenience of the donor, the concentrated platelets in the intermediate bag 27a are collected in the plasma collection bag 25, It can be used as a raw plasma for a plasma fractionation preparation.

  In addition, the blood component collection device 1 operates (reverses) the second liquid feeding pump 12 to transfer the platelet preparation (platelets) in the platelet collection bag 26 via the filtration line 61 and the refilling line 62 (via And a second transfer operation (transfer operation from the platelet collection bag 26) for collecting (collecting) the plasma in the plasma collection bag 25. Thereby, the platelet preparation in the platelet collection bag 26 can be easily and reliably collected in the plasma collection bag 25. For this reason, as described above, when the component blood collection is stopped halfway, the platelet preparation in the platelet collection bag 26 can be collected in the plasma collection bag 25 and used as the raw plasma of the plasma fractionation preparation. The process up to the middle of the second transfer operation is the same as the first process of the refilling operation. That is, the second transfer operation includes the first step of the refilling operation.

  Here, as the transfer operation start buttons (switches) for starting the first transfer operation and the second transfer operation, for example, they can be displayed on the display / operation unit 17 and used.

  In this case, a transfer operation start button for starting the first transfer operation and a transfer operation start button for starting the second transfer operation may be provided separately, or a single transfer operation start may be provided. A button may be provided, and when the transfer operation start button is pressed (touched), both the first transfer operation and the second transfer operation may be executed.

  Further, when both the first transfer operation and the second transfer operation are executed, either one may be executed first, and then the other may be executed. , May be executed simultaneously.

  In addition, the blood component collection device 1 performs the filtration operation, then operates the second liquid feeding pump 12 to send the plasma collected in the plasma collection bag 25 to the intermediate bag 27a or the platelet collection bag 26. Thus, an amount adjustment operation for adjusting the volume amount (amount) of the platelet preparation (platelet) collected in the platelet collection bag 26 can be executed.

  Next, the operation of the blood component collection device 1 during the refilling operation, the first transfer operation, and the second transfer operation will be described.

First, the operation of the blood component collection device 1 during the refilling operation will be described.
FIG. 3 is a flowchart for explaining the operation of the blood component collection device shown in FIG. 1. FIG. 3 shows the control operation of the control unit 3 in the refilling operation.

  When the operator operates the display / operation unit 17 and presses the refill operation start button displayed on the display / operation unit 17, the refill operation is started.

  As shown in FIG. 3, first, the second flow path opening / closing means 82 is opened, and the seventh flow path opening / closing means 87 is closed (step S101).

  Next, the second liquid feeding pump 12 is operated (reversely rotated) (step S102). In step S102, the second liquid feed pump 12 is rotated a predetermined number of times and stopped.

Thereby, the platelet preparation (platelet) collected in the platelet collection bag 26 passes through the tube 48, the branch connector 22g, the leukocyte removal filter 261, the tube 47, and the branch connector 22e to the middle of the tube 49 (or the branch connector 22e). The liquid is sent. As a result, the air accumulated in the filtration line 61 between the leukocyte removal filter 261 and the branch connector 22e and the inflow side space of the leukocyte removal filter 261 is removed. That is, the filtration line 61 between the leukocyte removal filter 261 and the branch connector 22e and the air in the leukocyte removal filter 261 are replaced with the platelet preparation. The tube 48 is maintained in a state filled with the platelet preparation before the refilling operation is started unless the filter (vent filter) 22h cap is opened.
Thus, the first process is completed, and the process proceeds to the second process.

  In the second step, first, the second flow path opening / closing means 82 is closed, and the seventh flow path opening / closing means 87 is opened (step S103).

  Next, the second liquid feeding pump 12 is operated (forward rotation) (step S104). In step S104, the second liquid feed pump 12 is rotated a predetermined number of times and stopped.

  Thus, the plasma collected in the plasma collection bag 25 is sent to the intermediate bag 27a via the tube 49, the connector 22d, the connector 22e, and the tube 46 provided in the middle of the tube 49. As a result, air accumulated in the filtration line 61 between the branch connector 22e and the intermediate bag 27a is removed. That is, the air in the filtration line 61 between the branch connector 22e and the intermediate bag 27a is replaced with plasma.

  Thus, the second step is finished, and this refilling operation is finished. Thereby, air is removed from the whole filtration line 61, and it becomes possible to perform filtration operation.

  In addition, when adding the blood component collection operation cycle and performing the blood component collection operation and the filtration operation for the added amount, the timing of performing the refill operation is not particularly limited, and the refill operation is performed, for example, blood component collection It may be performed before starting the operation, or may be performed after collecting concentrated platelets in the intermediate bag 27a.

Next, the operation of the blood component collection device 1 during the first transfer operation will be described.
FIG. 4 is a flowchart for explaining the operation of the blood component collection device shown in FIG. 1. FIG. 4 shows the control operation of the control unit 3 in the first transfer operation.

  When the operator operates the display / operation unit 17 and presses the first transfer operation start button displayed on the display / operation unit 17, the first transfer operation is started.

  As shown in FIG. 4, first, the second flow path opening / closing means 82 is closed, and the seventh flow path opening / closing means 87 is opened (step S201).

  Next, the second liquid feeding pump 12 is operated (reversely rotated) (step S202). Thereby, the concentrated platelets (platelets) in the intermediate bag 27a are sent to the plasma collection bag 25 through the tube 46, the connector 22e, the tube 49, and the connector 22d provided in the middle of the tube 49.

  Next, it is determined whether or not air is detected by the bubble sensor 33 (step S203). If air is not detected in step S203, the process returns to step S202, and step S202 and subsequent steps are executed again.

  If air is detected in step S203, the second liquid feed pump 12 is rotated (reversed) a predetermined number of times and stopped (step S202).

  Thus, the first transfer operation is completed. Thereby, the plasma in the intermediate bag 27a is collected in the plasma collection bag 25, and can be used, for example, as a raw material plasma of a plasma fractionation preparation.

Next, the operation of the blood component collection device 1 during the second transfer operation will be described.
FIG. 5 is a flowchart for explaining the operation of the blood component collection device shown in FIG. 1, and FIG. 5 shows the control operation of the control unit 3 in the second transfer operation.

  When the operator operates the display / operation unit 17 and presses the second transfer operation start button displayed on the display / operation unit 17, the second transfer operation is started.

  As shown in FIG. 5, first, the second channel opening / closing means 82 is opened and the seventh channel opening / closing means 87 is closed (step S301).

  Next, the second liquid feeding pump 12 is operated (reversely rotated) (step S302). In step S302, the second liquid feed pump 12 is rotated a predetermined number of times and stopped. This completes the second transfer operation.

  The rotation speed of the second liquid feeding pump 12 at this time is calculated from the collected amount of concentrated platelets, the loss amount by the leukocyte removal filter 261, and the liquid feeding amount per one rotation of the pump.

  As a result, the platelet preparation (platelet) in the platelet collection bag 26 contains the tube 48, the branch connector 22g, the leukocyte removal filter 261, the tube 47 and the branch connector 22e, the tube 49, and the branch connector 22d provided in the middle of the tube 49. Then, the solution is sent to the plasma collection bag 25 and collected in the plasma collection bag 25, and can be used, for example, as the raw plasma of the plasma fractionation preparation.

  As described above, the first transfer operation and the second transfer operation may be performed simultaneously. In this case, the second channel opening / closing means 82 and the seventh channel are operated. The opening / closing means 87 is opened, and the second liquid feed pump 12 is operated (reverse). The rotation speed of the second liquid feeding pump 12 at this time is calculated from the collected amount of concentrated platelets, the loss amount by the leukocyte removal filter 261, and the liquid feeding amount per one rotation of the pump. In addition, a pressure detection means may be provided between the branch connectors 22e and 22d, and the transfer may be terminated when it is detected that a strong negative pressure has been detected. Thereby, the concentrated platelets in the intermediate bag 27a are sent to the plasma collection bag 25 through the tube 46, the connector 22e, the tube 49, and the connector 22d provided in the middle of the tube 49, and at the same time, the platelet collection is performed. The platelet preparation in the bag 26 passes through the tube 48, the branch connector 22g, the leukocyte removal filter 261, the tube 47 and the branch connector 22e, the tube 49, and the branch connector 22d provided in the middle of the tube 49 to the plasma collection bag 25. The concentrated platelets and the platelet preparation are collected in the plasma collection bag 25.

  As described above, according to the blood component collecting apparatus 1, the air accumulated in the inflow side space of the leukocyte removal filter 261 and the filtration line 61 between the leukocyte removal filter 261 and the intermediate bag 27a can be removed. Therefore, even if the filtration operation is completed and the intermediate bag 27a is emptied, the filtration operation can be performed again. That is, even when the filtration operation is completed and the intermediate bag 27a is emptied, a blood component collection operation cycle is added, and the blood component collection operation is executed to collect the concentrated platelets temporarily stored in the intermediate bag 27a. The leukocytes can be supplied to the leukocyte removal filter 261, separated and removed by the leukocyte removal filter 261, and collected (collected) in the platelet collection bag 26. For this reason, the cycle of blood component collection operation can be added freely, and thereby, a platelet preparation conforming to the preparation standard can be obtained with certainty.

  In addition, when for some reason (forcibly) the withdrawal of blood components is interrupted, concentrated platelets and platelet preparations that do not conform to the drug product specifications can be collected in the plasma collection bag 25, so that they are collected from the donor without any hassle. It is economical because blood components can be used effectively.

  Moreover, since the blood component collection device 1 has the second liquid feeding pump 12, the plasma collection bag 25 is positioned at substantially the same height as the blood storage space 146 of the rotor 142 of the centrifuge 20. In addition, it is possible to easily adjust the volume (amount) of concentrated platelets (platelet preparation) using the plasma in the plasma collection bag 25 and without going through the centrifuge 20.

  Further, in this blood component collecting apparatus 1, since the leukocytes are separated and removed by the leukocyte removal filter 261 from the concentrated platelets separated and collected from the blood, a platelet preparation with extremely low leukocyte contamination can be obtained.

  As mentioned above, although the blood component collection device of the present invention has been described based on the illustrated embodiment, the present invention is not limited to this, and the configuration of each part is an arbitrary configuration having the same function. Can be replaced. Moreover, other arbitrary structures and processes may be added to the present invention.

  In addition, 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 to obtain platelet preparations from blood. You may apply.

  In addition, the blood component collection device of the present invention is not limited to the application to obtaining a platelet preparation or a plasma preparation, but may be applied to obtaining an erythrocyte preparation or the like from blood, for example. 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 may be, for example, red blood cells (red blood cells including plasma).

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

  In the present invention, the cells separated and removed by the cell separation filter (filter) are not limited to leukocytes.

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

It is a top view which shows embodiment of the blood component collection device of this invention. It is a partially broken sectional view of the state where the centrifuge was installed in the centrifuge drive device with which the blood component collection device shown in FIG. 1 is provided. It is a flowchart for demonstrating the effect | action of the blood component collection device shown in FIG. It is a flowchart for demonstrating the effect | action of the blood component collection device shown in FIG. It is a flowchart for demonstrating the effect | action of the blood component collection device shown in FIG.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Blood component collection apparatus 2 Blood component collection circuit 3 Control part 10 Centrifugal drive device 11 1st liquid feed pump 12 2nd liquid feed pump 13 3rd liquid feed pump 14 Turbidity sensor 15 Optical sensor 151 Throw Light unit 152 Light receiving unit 153 Reflector 16 Weight sensor 17 Display / operation unit 18 Storage unit 20 Centrifuge 21 First line 21a Blood collection needle side first line 21b Centrifuge side first line 21c Branch connector 21d Chamber 21f Branch Connector 21g First pump tube 21h Tube 21i Filter 22 Second line 22a Second pump tube 22b Branch connector 22c Branch connector 22d Branch connector 22e Branch connector 22f Filter 22g Branch connector 22h Filter 23 Third line 23 a third pump tube 23b sanitization filter 23c bubble removal chamber 23d anticoagulant container connection needle 24 plasma circulation line 25 plasma collection bag 26 platelet collection bag 261 leukocyte removal filter 27a intermediate bag 27b air bag 28 bag 29 blood collection Needle 31-36 Bubble sensor 41-51 Tube 61 Filtration line 62 Refilling line 81-87 First to seventh flow path opening / closing means 131 Plasma layer 132 Buffy coat layer 133 Red blood cell layer 141 Tubular 142 Rotor 143 Inlet 144 Discharge port 145 Upper part 146 Blood storage space 147 Reflecting surface 201 Housing 202 Leg part 203 Motor 204 Rotating shaft 205 Fixing stand 206 Bolt 207 Spacer S101 to S104 Step S201 to S204 Step S301 S302 step

Claims (8)

Blood collection means for collecting blood from a donor,
A blood separator for separating blood collected by the blood collection means into a plurality of blood components;
A plasma collection bag for collecting plasma separated by the blood separator;
A temporary storage bag for temporarily storing a predetermined blood cell component separated by the blood separator;
A cell separation filter for separating and removing predetermined cells from the predetermined blood cell component;
A blood component collection bag for collecting the predetermined blood cell component after passing through the cell separation filter;
A filtration line for transferring the predetermined blood cell component from the temporary storage bag to the blood component collection bag through the cell separation filter;
A blood component collection circuit comprising a liquid supply line branched from a branch portion provided between the temporary storage bag and the cell separation filter in the filtration line, and connected to the plasma collection bag;
Liquid feeding means installed in the liquid feeding line ;
A controller for controlling the operation of the liquid feeding means ,
The control unit performs a filtering operation of supplying the predetermined blood cell component from the temporary storage bag to the cell separation filter, separating and removing the predetermined cell by the cell separation filter, and collecting the blood cell collection bag. After the execution, the liquid feeding means is operated, and the predetermined blood cell component collected in the blood component collection bag or the predetermined blood cell component collected in the blood component collection bag and the plasma collected in the plasma collection bag A blood component collection apparatus characterized by performing a refilling operation of sending liquid to the filtration line and removing air in the filtration line. In the refilling operation, the control unit operates the liquid feeding means to feed a predetermined blood cell component collected in the blood component collection bag to the branching unit, and the cell separation filter in the filtration line. A first step of removing air between the cell separation filter and the cell separation filter;
The control unit operates the liquid feeding means to transfer the plasma collected in the plasma collection bag to the temporary storage bag via the transfer line, and the branching unit and the temporary in the filtration line. blood component collection apparatus according to claim 1 to perform the second step of removing the air between the reservoir bag. The refilling operation, after the first step is completed, the blood component collection apparatus according to claim 2 for performing the second step. The control unit operates the liquid feeding means to execute a first transfer operation for collecting the predetermined blood cell component from the temporary storage bag to the plasma collection bag via the filtration line and the transfer line. blood component collection apparatus according to any one of claims 1 to 3. The controller activates the liquid feeding means to perform a second transfer operation for collecting the predetermined blood cell component from the blood component collection bag to the plasma collection bag via the filtration line and the transfer line. The blood component collection device according to any one of claims 1 to 4 to be executed.   6. When using the blood component collection device, the blood component collection bag is provided so that a flow path side communicating with the cell separation filter is vertically downward. Blood component collection device. The filtration operation by drop to the predetermined blood cell components, wherein a sending from the temporary reservoir bag to the cell separation filter, said to 請 Motomeko no 1 you transfer the blood component collection bag via the cell separation filter The blood component collection device according to any one of 6.   The blood component collecting apparatus according to any one of claims 1 to 7, wherein the predetermined blood cell component is concentrated platelets.

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