JP4681393B2 - 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, the platelets (platelet containing plasma) are separated from the buffy coat, the platelets containing plasma are collected in a platelet collection bag to obtain a platelet preparation, and the plasma is also collected in the plasma collection bag. The remaining plasma, white blood cells, and red blood cells are used as raw materials for the plasma preparation or plasma fraction preparation, and returned to the donor (see, for example, Patent Document 1).

  In addition, the number of cycles of blood component collection operation in such a blood component collection device is set with priority on the number of platelets so that the number of platelets (unit number) collected in the platelet collection bag conforms to the formulation standard. . When the volume of platelets containing the collected plasma (hereinafter also simply referred to as “amount”) falls below the formulation standard, the plasma collection is performed so that the amount of platelets including plasma conforms to the formulation standard. An operation (amount adjustment operation) of adding plasma in the bag and adjusting the amount of platelets containing the plasma is performed.

In the standard of platelet preparations, for example, the 10-unit preparation has a platelet count of 2.0 × 10 ^{11 to} 2.9 × 10 ¹¹ and the amount of platelets including plasma is 160 to 240 mL. For blood donors with high hematocrit and high platelet concentration, it may be possible to collect as many platelets as 10 units in 2 cycles, but the amount of plasma collected is small due to the high hematocrit value. Even if the operation is performed, the amount of plasma may be insufficient, and the amount of platelets containing plasma may fall below the standard for 10-unit preparations. In this case, platelets containing plasma collected in the platelet collection bag cannot be made into a platelet product in a unit suitable for the number even though the platelet count sufficiently satisfies the formulation standard, and discarded. This is uneconomical because it is used as a raw material for a plasma fractionated preparation or a low unit preparation.

  By the way, the blood component collection device described in Patent Document 1 does not consider the case where the amount of platelets including plasma collected in the platelet collection bag falls below the formulation standard, but in a predetermined cycle. After collecting platelets containing plasma in the platelet collection bag, additional blood collection is performed in the cycle, and plasma is collected in the plasma collection bag.

  However, in the blood component collection device described in Patent Document 1, additional blood collection is started and plasma collection is performed in a state where red blood cells remain in the centrifuge after platelet collection. There is a problem that the amount is reduced.

JP 2005-46400 A

  An object of the present invention is to provide a blood component collection device that can reliably obtain a blood product (for example, a platelet product) that complies with the product specifications without increasing the burden on the blood donor.

Such an object is achieved by the present inventions (1) to (7) below.
(1) Blood collection means 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 circuit comprising a blood component collection bag for collecting a predetermined blood cell component containing plasma separated by the blood separator;
A blood plasma collection step for separating the collected blood and collecting the plasma in the plasma collection bag, a blood component collection step for collecting a predetermined blood cell component including plasma in the blood component collection bag, and a remaining blood component A blood component collection device for performing at least one cycle of a blood component collection operation having a blood return step to return to
Plasma collected when the blood component collection operation of the number of cycles set so that the number of the predetermined blood cell components collected in the blood component collection bag reaches the first target value is performed in all cycles And a collection amount prediction means for predicting a total volume amount of a predetermined blood cell component including the collected plasma,
Determination means for determining whether or not the predicted value of the volume amount predicted by the collection amount prediction means reaches a second target value;
When it is determined by the determination means that the predicted value does not reach the second target value, the collected blood is separated, a plasma collection step for collecting plasma, and the remaining blood components are returned to the donor. A blood component collection device configured to perform at least one cycle of a plasma collection operation including a blood return step.

  (2) The blood component collection apparatus according to (1), wherein the plasma collection operation is configured to be executed after the blood component collection operation is performed for all the cycles.

  (3) The determination as to whether or not to perform the blood plasma collection operation is performed before starting the blood component collection operation of the first cycle, according to (1) or (2) above. Blood component collection device.

  (4) If the determination means determines that the predicted value does not reach the second target value, sampling is performed when the predicted value and the plasma collection operation for the set number of cycles are performed for all cycles. (1) to (3), further comprising cycle number setting means for setting the number of cycles for performing the plasma collection operation so that the total value of the predicted volume of plasma volume reaches the second target value. The blood component collection device according to any one of the above.

  (5) The second target value is set to a value in the range of A to 600 mL, where A is the minimum value for conforming to the formulation standard of the volume amount of the predetermined blood cell component including the plasma. The blood component collection device according to any one of (1) to (4), configured as described above.

  (6) In at least one cycle of the plasma collection operation, a predetermined amount of plasma flowing out from the outlet of the blood separator is collected in the blood component collection bag, and the remaining plasma is collected in the plasma collection bag. The blood component collection device according to any one of (1) to (5), which is configured to collect.

  (7) The blood component collection device according to any one of (1) to (6), wherein the predetermined blood cell component is platelets.

  According to the present invention, it is possible to reliably obtain a blood product (for example, a platelet product) that conforms to the product specification.

  In addition, since the added plasma collection operation collects only the deficient plasma and does not collect other blood components (blood cell components), it has a step of collecting plasma and a step of collecting predetermined blood cell components. Compared to simply increasing the number of blood component collection operations, the burden on the blood donor can be reduced, and a predetermined blood cell component is not wasted, which is economical. Time can be shortened.

  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 an embodiment of a blood component collection device of the present invention, and FIG. 2 is a state in which a centrifuge is attached to a centrifuge drive device provided in the blood component collection device shown in FIG. It is a fragmentary sectional view.

  A blood component collection device 1 shown in FIG. 1 separates blood into a plurality of blood components and collects platelets (blood cell components) (blood components) containing plasma and plasma (blood components). It is. 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 (blood component collection bag) 25 connected to the second line 22 via the tubes 43 and 44, and connected to the second line 22 via the tube 42. Air bag 27b, intermediate bag (temporary storage bag) (blood component collection bag) 27a connected to second line 22 via tubes 43 and 45, and intermediate bag 27a via tubes 46, 47 and 48. A blood component collection circuit (blood processing circuit) 2 having a platelet collection bag (blood component collection bag) 26 connected to the blood vessel and a bag 28 connected to the platelet collection bag 26 via a tube 51 is provided.

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

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. A line (blood collection and blood return line) 21, one end side of the second line 22 connected to the outlet (outlet) 144 of the centrifuge 20, and a blood collection needle 29 of the first line 21 are connected. A third line (anticoagulant injection line) 23 having a second pump tube 23 a, a tube 50 connected to the blood collection needle 29 side from the pump tube 21 g of the first line 21, and a tube 50. A tube 43 connected to the second line 22; a tube 44 connected to the tube 43; a plasma collection bag 25 connected to the tubes 44 and 49; The tube 42 connected to the line 22, the air bag 27b connected to the tube 42, the tube 45 connected to the tube 43, the intermediate bag 27a connected to the tube 45, and the intermediate bag 27a Tube 46, Tube 47 connected to tube 46, Tube 48, Platelet collection bag 26 connected to tube 48, Tube 51 connected to platelet collection bag 26, Bag 28 connected to tube 51 And. 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. 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 branch connector 21f.

  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 21b is connected to a branch connector 21f for connection with the tube 50, and has a first pump tube 21g formed in the middle thereof.

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 second 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 second 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 is a container for collecting (storage) plasma (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.

  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.

  The platelet (platelet preparation) collection bag 26 is a container for collecting (reserving) platelets (blood cell component) (first blood component) containing plasma after passing through a leukocyte removal filter 261 described later. 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, which is a blood component collection bag, is a container (storage unit) for temporarily storing concentrated platelets, that is, platelets including plasma (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 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.

  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 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, 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 leukocytes from the concentrated platelets.

  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. The leukocyte removal filter 261 is set at a position lower than the plasma collection bag 25 (downward in the vertical direction) 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). The intermediate bag 27a and the plasma collection bag 25 are respectively positioned higher (vertically upward) than the blood storage space 146 of the rotor 142 of the centrifuge 20.

  In this case, the blood component collection device 1 is provided with hangers (hooks) (not shown), which are support portions that detachably support the plasma collection bag 25, the intermediate bag 27a, and the air bag 27b. The plasma collection bag 25 and the intermediate bag 27a are respectively hooked and hung (suspended) on the corresponding hangers so that the outlet side (inlet side) is vertically downward.

  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, the pump tubes 21g and 23a, and the other tubes 41 to 51 and 21h, polyvinyl chloride is used. 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 and 23a, what has the intensity | strength of the grade which is not damaged even if it presses with each liquid feeding pump (for example, roller pump etc.) 11 and 12 mentioned later, respectively is used.

  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 partially stores each line (the first line 21, the second line 22, and the third line 23) and each predetermined tube, and partially holds them. In other words, it comprises a cassette housing in which they are partially fixed.

  Both ends of the first pump tube 21g and the both ends of the second pump tube 23a are fixed to the cassette housing. The pump tubes 21g and 23a are respectively connected to the liquid feeding pumps (for example, roller rollers) from the cassette housing. The pump protrudes in a loop shape corresponding to the shape of 11 and 12. For this reason, the 1st and 2nd pump tubes 21g and 23a are easy to mount on the liquid feeding pumps 11 and 12, 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 drive 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 third The flow path of the second liquid feeding pump 12 installed in the middle of the line 23 and the blood component collection circuit 2 (first line 21, tube 42, tube 44, tube 45, tube 47, tube 49, tube 50). A plurality of flow path opening / closing means 81, 82, 83, 84, 85, 86, 87, a display means (notification means) for displaying (notifying) various information, and an operation means for performing each operation. In order to control a certain display / operation unit 17, the centrifuge drive device 10, the first liquid feeding pump 11, the second liquid feeding pump 12, the plurality of channel opening / closing means 81 to 87, and the display / operation unit 17. Control part (control And it means) 13.

  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 13 includes two pump controllers (not shown) for the first liquid feeding pump 11 and the second liquid feeding pump 12, and the control unit 13, the first liquid feeding pump 11, and the second liquid feeding pump 12. The liquid feed pump 12 is 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 13.
Each of the channel opening / closing means 81 to 87 is electrically connected to the control unit 13.

  Further, the turbidity sensor 14, the optical sensor 15, the weight sensor 16, the bubble sensors 31 to 36, and the display / operation unit 17 are each electrically connected to the control unit 13.

  The control unit 13 is composed of, for example, a microcomputer. The control unit 13 receives detection signals from the turbidity sensor 14, the optical sensor 15, the weight sensor 16, and the bubble sensors 31 to 36, as needed. Entered. A signal (input) from the display / operation unit 17 is also input to the control unit 13.

  The control unit 13 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 of the liquid feed pumps 11 and 12 is controlled. The operation of the separator driving device 10 and the driving of the display / operation unit 17 are controlled.

  The control unit 13 sets a platelet collection operation (blood component collection operation), which will be described later, such that the number of platelets (unit number) of the concentrated platelets collected in the intermediate bag 27a reaches the first target value. A collection amount predicting means for predicting the total volume of the plasma collected in the plasma collection bag 25 and the concentrated platelets (platelets containing plasma) collected in the intermediate bag 27a when all the cycles are performed; A determination means for determining whether or not the predicted value of the volume amount predicted by the collection amount prediction means reaches a second target value, and a cycle number setting for setting the number of cycles for performing a plasma collection operation to be described later Means.

  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 branch connector 21f and the chamber 21d.

  The second flow path opening / closing means 82 is provided to open / close the tube 50. 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 49. The seventh flow path opening / closing means 87 is provided to open / close the tube 47.

  Each of the flow path opening / closing means 81 to 87 includes an insertion portion into which the first line 21 and the tubes 50, 44, 45, 42, 49, and 47 can be inserted. 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 13.

  The display / operation unit 17 includes, for example, a touch panel including a liquid crystal display panel, an EL display panel, and the like.

  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.

  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.

  As the first liquid delivery pump 11 to which the first pump tube 21g is attached and the second liquid delivery pump 12 to which the second pump tube 23a is attached, for example, non-blood such as a roller pump, respectively. A contact type 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.

Next, the operation (operation) of the blood component collection device 1 will be described.
First, a platelet collection operation (blood component collection operation) using the blood component collection apparatus 1 will be described.

  The blood component collection device 1 is controlled by the control unit 13 so that the first plasma collection step of collecting plasma in the plasma collection bag 25, the constant-speed plasma circulation step, and the second of collecting plasma in the plasma collection bag 25 A plasma collection step, an accelerated plasma circulation step, a third plasma collection step for collecting plasma in the plasma collection bag 25, a platelet collection step (blood component collection step) for collecting concentrated platelets in the intermediate bag 27a, and blood return It operates to perform a platelet collection operation (blood component collection operation) having a process (blood component return process).

  A plasma collection bag is obtained by performing 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. A predetermined amount of plasma is collected at 25, and concentrated platelets are collected (temporarily stored) in the intermediate bag 27a. In addition, blood components (remaining blood components) remaining in the blood storage space 146 of the rotor 142 of the centrifuge 20 (mainly red blood cells, white blood cells, and remaining plasma) are removed from the centrifuge by performing the blood return process. The blood is discharged from the 20 inlets 143 and 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). The platelet collection operation is usually performed a plurality of times (a plurality of cycles).

  In addition, the said platelet collection operation can be performed using the method described in Unexamined-Japanese-Patent No. 2005-152362 etc., for example.

  In addition, the blood component collection device 1 supplies the concentrated platelets temporarily collected (stored) in the intermediate bag 27a to the leukocyte removal filter 261 under the control of the control unit 13, and filters the concentrated platelets, that is, the concentrated platelets. A filtration operation (filtration process) for separating and removing white blood cells in platelets is performed.

  In this filtering operation, the seventh flow path opening / closing means 87 is opened. Thereby, the concentrated platelets in the intermediate bag 27a are transferred into the platelet collection bag 26 through the tubes 46 and 47, the leukocyte removal filter 261 and the tube 48 due to a drop (self-weight). 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 plasma collection operation of the final cycle, or after the plasma collection operation of the final cycle is completed when the plasma collection operation described later is added, and the plasma collection operation is not added. In this case, it is performed in parallel with the platelet collection operation of the final cycle or after the completion of the platelet collection operation of the final cycle.

  The transfer of the concentrated platelets from the intermediate bag 27a to the platelet collection bag 26 may be performed using a pump.

  Moreover, the blood component collection device 1 supplies the plasma in the plasma collection bag 25 to the intermediate bag 27a as required by the control of the control unit 13, whereby the amount of concentrated platelets collected in the intermediate bag 27a ( The volume adjustment operation is performed to adjust the volume). Thus, the amount (volume) of the platelet preparation collected in the platelet collection bag 26 is adjusted.

  The blood component collection device 1 is configured to collect the platelets in the number of cycles set so that the number of platelets (unit number) of the concentrated platelets collected in the intermediate bag 27a reaches the first target value (blood). The total volume of the plasma collected in the plasma collection bag 25 and the concentrated platelets (platelets containing plasma) collected in the intermediate bag 27a (hereinafter simply referred to as “quantity”) Is also determined), and it is determined whether or not the predicted value reaches the second target value. If it is determined that the predicted value does not reach the second target value, It is configured to add (perform) at least one cycle of a plasma collection operation including a plasma collection step of separating and collecting plasma and a blood return step (blood component return step) of returning the remaining blood components to the donor. Yes. In this plasma collection operation, plasma is collected in the intermediate bag 27a, the plasma collection bag 25, or both the intermediate bag 27a and the plasma collection bag 25. Since the steps (constant plasma circulation method, accelerated plasma circulation step) and the platelet collection step are omitted, detailed description thereof will be omitted. Hereinafter, a detailed description will be given based on FIG. 3 and FIG. 4.

  3 and 4 are flowcharts for explaining the operation of the blood component collection device shown in FIG. 1 (flow chart showing the control operation of the control unit 13).

  When performing component blood collection, prior to the platelet collection operation in the first cycle, as shown in FIG. 3, the number of cycles (a) of the platelet collection operation is set (step S101).

  In this step S101, the number of platelets (unit number) of the concentrated platelets collected in the intermediate bag 27a based on the donor's hematocrit value, blood count such as platelet concentration, etc., becomes the platelet product standard (target standard). Determine the minimum number of cycles of platelet collection operations required to reach a suitable first target value. Then, the obtained cycle number is set as the cycle number (a) of the platelet collection operation.

As platelet preparations, there are the following four types (1) to (4).
(1) 5 unit preparation Volume (amount) is 100 mL ± 20%, number is 1.0 × 10 ^{11 to} 1.9 × 10 ¹¹ (2) 10 unit preparation Volume (amount) is 200 mL ± 20% The number is 2.0 × 10 ^{11 to} 2.9 × 10 ¹¹ (3) 15 unit preparation The volume (amount) is 250 mL ± 20%, the number is 3.0 × 10 ^{11 to} 3.9 × 10 ^Eleven (4) 20 unit preparations Volume (amount) is 250 mL ± 20%, number is 4.0 × 10 ¹¹ or more, and “1 unit” of platelets is 0.2 × 10 ¹¹ .

  Note that the number of cycles for the platelet collection operation may not be automatically obtained in the blood component collection device 1. For example, the operator obtains the number of cycles for the platelet collection operation and determines the number of cycles. It may be configured to input to the device.

  Next, when the platelet collection operation is performed for all the set number of cycles (a), the total volume amount of the plasma collected in the plasma collection bag 25 and the concentrated platelets collected in the intermediate bag 27a is calculated. Prediction is performed (step S102).

  In this step S102, the predicted value of the volume amount is the total volume amount of the plasma collected in the plasma collection bag 25 and the concentrated platelets collected in the intermediate bag 27a when the platelet collection operation is performed for one cycle. (Amount collected per cycle) is obtained from the following formula (1), and the value is multiplied by a.

Amount collected per cycle (volume) = blood throughput-volume of centrifuge blood storage space during rotation (1)
Further, the blood throughput in the above formula (1) is obtained from the following formula (2).

Blood processing amount = K × B / Hct (2)
However, in the above formula (2), K: volume occupied by the red blood cell layer in the blood storage space of the centrifuge at the end of blood collection (just before the start of the platelet collection process) B: centrifugation at the end of blood collection (just before the start of the platelet collection process) The hematocrit value of the red blood cell layer in the blood storage space of the vessel Hct: The hematocrit value of the donor's blood The values of K and B are determined experimentally and set in advance. The value of Hct is obtained by preliminary blood collection and is set in advance.

  Next, the predicted value obtained in step S102 is compared with the second target value, and whether or not the predicted value reaches the second target value, that is, the predicted value is greater than or equal to the second target value. Whether or not (step S103).

  Here, when the minimum value for conforming to the formulation standard (target formulation standard) of the volume amount of the platelet preparation is A, the second target value is set to a value in the range of about A to 600 mL. It is preferable.

  When the predicted value is equal to or greater than the second target value (“YES” in step S103), it is estimated that a sufficient amount (volume amount) of plasma and concentrated platelets are collected, without adding a plasma collection operation, The process proceeds to step S106.

  On the other hand, if the predicted value is less than the second target value (“NO” in step S103), it is estimated that the amount of plasma and concentrated platelets (volume) is insufficient, and at least one cycle of plasma collection operation is added. In this case, first, the number of plasma collection operations to be added (b) is determined (step S104).

  In this step S104, the total value of the predicted value of the amount (volume) of plasma collected by the added plasma collection operation and the predicted value obtained in step S102 reaches the second target value. To determine the minimum number of cycles required for plasma collection. Then, the cycle number (b) of the plasma collection operation is determined to be the obtained cycle number.

  Next, the number of cycles (b) determined in step S104 is set as the number of plasma collection operations (step S105). Thus, b cycles of the plasma collection operation are added after the platelet collection operation of the final cycle, and the plasma collection operation is performed after the platelet collection operation is performed a cycle (all cycles), that is, the platelet collection operation of the final cycle is performed. Executed after doing.

  The plasma collection operation is not limited to after the platelet collection operation has been performed for all cycles. For example, the plasma collection operation is performed before the platelet collection operation of the first cycle or between a predetermined cycle of the platelet collection operation and the next cycle. May be.

  Next, the total number of cycles (c), which is the sum of the number of cycles of platelet collection operation (a) and the number of cycles of plasma collection operation (b), is displayed on the display / operation unit 17.

  Thereby, it is possible for the operator to use it with the same operability as in the past (when using an apparatus without an automatic additional function of plasma collection operation).

  Next, preparation of component blood collection is performed, and platelet collection operation is performed as shown in FIG. 4 (step S201).

  Next, it is determined whether or not the platelet collection operation has been completed for all cycles (a cycle) (step S202).

  If the platelet collection operation has not been completed for all cycles, the process returns to step S201, and the platelet collection operation for the next cycle is performed.

On the other hand, when the platelet collection operation has been completed for all cycles, it is determined whether or not a plasma collection operation has been added (step S203).
If no plasma collection operation has been added, the component blood collection is terminated.

  On the other hand, when the plasma collection operation is added, the plasma collection operation is performed (step S204).

  Next, it is determined whether or not the plasma collection operation has been completed for all cycles (b cycles) (step S205).

If the plasma collection operation has not been completed for all cycles, the process returns to step S204, and the plasma collection operation for the next cycle is performed.
On the other hand, when the plasma collection operation is completed for all cycles, the component blood collection is terminated.

  Here, in the plasma collection operation, it is preferable that the plasma flowing out from the discharge port 144 of the centrifugal separator 20 is collected in the intermediate bag 27a. Thereby, the amount (volume amount) of the concentrated platelets collected in the intermediate bag 27a can be made to reach the second target value without performing the amount adjustment operation described above. Further, when the amount of concentrated platelets collected in the intermediate bag 27a reaches a value (minimum value A) conforming to the formulation standard, it is preferable to switch the plasma collection destination (storage destination) to the plasma collection bag 26. . Hereinafter, a specific example will be given and further described.

  When the second target value is set to a value (minimum value A) that conforms to the formulation standard, all the plasma flowing out from the outlet 144 of the centrifuge 20 until the last cycle before the final cycle is stored in the intermediate bag. Take on 27a. In the final cycle, first, plasma flowing out from the outlet 144 of the centrifuge 20 is collected in the intermediate bag 27a, and the amount (volume) of concentrated platelets collected in the intermediate bag 27a is a value that meets the formulation standard. When (minimum value A) is reached, the fourth channel opening / closing means 84 is closed, the third channel opening / closing means 83 is opened, and plasma is collected in the plasma collection bag 26.

  However, if the value (minimum value A) that meets the formulation specifications is reached before reaching the final cycle, the plasma collection process may be terminated at that time, and the blood return process may be executed. In this case, the subsequent cycles need not be executed.

  Further, when the second target value is set to a value larger than a value (minimum value A) that conforms to the formulation standard, first, in the predetermined one cycle of the plasma collection operation, the outlet 144 of the centrifuge 20 is first used. When the plasma flowing out of the intermediate bag 27a is collected in the intermediate bag 27a and the amount (volume) of the concentrated platelets collected in the intermediate bag 27a reaches a value (minimum value A) that meets the formulation standard, the fourth flow path The opening / closing means 84 is closed, the third flow path opening / closing means 83 is opened, and plasma is collected in the plasma collection bag 26. If the cycle for collecting both is not the final cycle, all the plasma flowing out from the outlet 144 of the centrifuge 20 is collected in the plasma collection bag 26 from the subsequent cycle to the final cycle.

  However, when the amount of plasma collected in the plasma collection bag 26 reaches the target amount, the plasma collection process may be terminated and the blood return process may be executed. In this case, the plasma collection operation is not performed thereafter even if the number of cycles of the plasma collection operation performed so far has not reached the set number of cycles.

  In this way, in a predetermined cycle of the plasma collection operation, a predetermined amount of plasma flowing out from the outlet 144 of the centrifuge 20 is collected in the intermediate bag 27a, and the remaining plasma is collected in the plasma collection bag 26. By doing so, it is possible to prevent the amount of concentrated platelets collected in the intermediate bag 27a from being increased unnecessarily (unnecessarily), and the amount of plasma collected in the plasma collection bag 26 can be increased.

  In the present invention, two or more cycles for collecting plasma in both the intermediate bag 27a and the plasma collection bag 26 may be provided.

  In the present invention, in the plasma collection operation, the plasma flowing out from the outlet 144 of the centrifuge 20 may be collected only in the intermediate bag 27a, or may be collected only in the plasma collection bag 26.

  As described above, according to the blood component collecting apparatus 1, a platelet preparation that conforms to the specifications of the platelet preparation can be obtained with certainty.

  In addition, since the added plasma collection operation collects only the deficient plasma and does not collect other blood components (blood cell components), the blood component collection includes a step of collecting plasma and a step of collecting platelets. Compared to simply increasing the number of operation cycles, the burden on the donor can be reduced, the platelets are not wasted, it is economical, and the blood collection time can be shortened. .

  Moreover, since the plasma collection operation is started in a state where no red blood cells remain in the blood storage space 146 of the centrifuge 20, it is possible to increase the amount (volume) of plasma that can be collected in one cycle of plasma collection operation. it can.

  In this blood component collection device 1, since the leukocytes are separated and removed from the concentrated platelets separated and collected from the blood by the leukocyte removal filter 261, 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 being applied to obtain a platelet preparation or a plasma preparation (or a raw material plasma of a plasma fractionation preparation). For example, an erythrocyte preparation, a leukocyte preparation, etc. You may apply when you get. That is, in the blood component collection device of the present invention, the blood component collected in the blood component collection bag is not limited to platelets including plasma, but may be red blood cells including plasma, white blood cells including plasma, or the like. In other words, in the blood component collection device of the present invention, the predetermined blood cell component collected is not limited to platelets, but may be, for example, red blood cells or white blood cells.

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

  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.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Blood component collection apparatus 2 Blood component collection circuit 10 Centrifuge drive device 11 1st liquid feeding pump 12 2nd liquid feeding pump 13 Control part 14 Turbidity sensor 15 Optical sensor 151 Light projection part 152 Light receiving part 153 Reflection Plate 16 Weight sensor 17 Display / operation 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 Pump tube 21h Tube 21i Filter 22 First Line 2b 22b Branch connector 22c Branch connector 22d Branch connector 22e Branch connector 22f Filter 22g Branch connector 22h Filter 23 Third line 23a Pump tube 23b Bacteria-removing filter 23c Bubble removal chamber 23d Anticoagulant container connection needle 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 Air bubble sensor 41-51 Tube 81-87 First to seventh flow Road opening / closing means 131 Plasma layer 132 Buffy coat layer 133 Red blood cell layer 141 Tubular body 142 Rotor 143 Inlet port 144 Outlet port 145 Upper part 146 Blood storage space 147 Reflecting surface 201 Housing 202 Leg part 203 Motor 204 Rotating shaft 205 Fixed base 206 Bolt 207 Spacer S101 ~ S106 step S201 ~ S205 step

Claims (7)

Blood collection means 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 circuit comprising a blood component collection bag for collecting a predetermined blood cell component containing plasma separated by the blood separator;
A blood plasma collection step for separating the collected blood and collecting the plasma in the plasma collection bag, a blood component collection step for collecting a predetermined blood cell component including plasma in the blood component collection bag, and a remaining blood component A blood component collection device for performing at least one cycle of a blood component collection operation having a blood return step to return to
Plasma collected when the blood component collection operation of the number of cycles set so that the number of the predetermined blood cell components collected in the blood component collection bag reaches the first target value is performed in all cycles And a collection amount prediction means for predicting a total volume amount of a predetermined blood cell component including the collected plasma,
Determination means for determining whether or not the predicted value of the volume amount predicted by the collection amount prediction means reaches a second target value;
When it is determined by the determination means that the predicted value does not reach the second target value, the collected blood is separated, a plasma collection step for collecting plasma, and the remaining blood components are returned to the donor. A blood component collection device configured to perform at least one cycle of a plasma collection operation including a blood return step.   The blood component collection apparatus according to claim 1, wherein the plasma collection operation is performed after the blood component collection operation is performed for the entire cycle.   The blood component collection device according to claim 1 or 2, wherein the determination as to whether or not to perform the plasma collection operation is performed before the blood component collection operation in the first cycle is started.   When it is determined by the determination means that the predicted value does not reach the second target value, the plasma collected when the plasma collection operation for the predicted value and the set number of cycles is performed for all cycles. The cycle number setting means which sets the cycle number which performs the said blood plasma collection operation so that the total value with the predicted value of the volume amount of this may reach the said 2nd target value is described in any one of Claim 1 thru | or 3 Blood component collection device.   The second target value is configured to be set to a value within the range of A to 600 mL, where A is the minimum value for conforming to the formulation standard of the volume amount of the predetermined blood cell component including the plasma. The blood component collection device according to any one of claims 1 to 4.   In at least one cycle of the plasma collection operation, a predetermined amount of plasma flowing out from the outlet of the blood separator is collected in the blood component collection bag, and the remaining plasma is collected in the plasma collection bag. The blood component collection device according to any one of claims 1 to 5, which is configured as described above. The blood component collection device according to any one of claims 1 to 6, wherein the predetermined blood cell component is platelets.

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