JP2005110748A - Blood component collecting apparatus - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a blood component collecting apparatus with which blood collecting time is shortened in the case of a donor of a stable blood collecting speed by accelerating a blood collecting speed in a prescribed range in accordance with the circulating blood amount of the donor. <P>SOLUTION: The blood component collecting apparatus 1 determines the blood collecting speed (a rotation speed of a first liquid feed pump 11) in accordance with the circulating blood amount calculated from the sex, body height and body weight of the donor, and also determines a centrifugal rotational speed (the number of rotation of a rotor 142) from the hematocrit value and blood collecting speed of the donor (S100A, S100B). Then, a centrifugal separator driving device 10, the first liquid feed pump 11, a second liquid feed pump 12 and a plurality of flow path opening/closing means 81-87 are controlled so that a platelet collecting operation including a plasma collecting process, a plasma circulating process, a platelet collecting process and an autotransfusing process is performed on the basis of the blood collecting speed and the centrifugal rotational speed determined in a step S100B. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

  The present invention relates to a blood component collection device used for component blood collection (platelet collection, plasma collection, and red blood cell collection). More specifically, the present invention relates to a blood component collection device that can shorten the blood collection time for a blood donor with a stable blood collection speed.

  At the time of blood collection, for the purpose of effective use of blood and reduction of burden on blood donors, the blood sample is separated into each blood component by centrifugation, etc., and only the components necessary for the transfuser are collected. Ingredients are collected to return the ingredients to the blood donor. In such component blood collection, when obtaining a platelet product, blood collected from a blood donor is introduced into a blood component collection circuit, and a centrifuge called a centrifuge bowl installed in the blood component collection circuit is used to obtain plasma and buffy coat. And separated into red blood cells, and the platelets are removed from the buffy coat and collected in a container to obtain a platelet preparation. A predetermined amount of plasma is also collected in another container as a raw material for the plasma preparation or plasma fractionation preparation, and the remaining plasma, White blood cells and red blood cells are returned to the donor.

  When such blood component collection is performed, for example, a blood component collection device disclosed in JP 2000-84066 A is used. When using this type of blood component collection device, for example, to collect platelets, it is required to collect the platelet count as desired, that is, there should be no unit breakage, and to shorten the platelet collection processing time as much as possible. ing.

In the blood component collection device disclosed in Japanese Patent Application Laid-Open No. 2000-84066, the above two requirements are satisfied by setting the centrifugal rotation speed and the like according to the hematocrit value of the blood donor. .
Japanese Unexamined Patent Publication No. 2000-84066 (pages 3 to 4, FIG. 1)

  However, the conventional blood component collection device has a problem that it is difficult to shorten the blood collection time because the blood collection speed is constant for all blood donors. Because, in actual blood collection, there are blood donors with stable blood collection speed and unstable blood donors, it is necessary to safely collect blood components according to the target from both, and the processing time is the hematocrit of the blood donor. This is because it was determined by the amount of extracorporeal circulation and the number of cycles depending on the value. For this reason, blood donors with a stable blood sampling rate, in other words, with a good physique and thick blood vessels, may be able to collect blood even at a speed higher than the current constant speed, although it is always constant. Applying blood collection speed and increasing processing time was ignored.

  Therefore, the present invention has been made to solve the above-described problems, and in the case of a blood donor whose blood collection speed is stable by increasing the blood collection speed within a predetermined range according to the blood circulation amount of the blood donor. It is an object of the present invention to provide a blood component collection device capable of shortening blood collection time.

  A blood component collection device according to the present invention made to solve the above-described problem has a rotor having a blood storage space therein, an inlet and an outlet communicating with the blood storage space, and the rotation of the rotor causes the A centrifuge for centrifuging the blood introduced from the inlet in the blood storage space; a first line for connecting a blood collecting means for collecting blood from a blood donor and the inlet of the centrifuge; and the centrifuge. Blood component collection having a second line connected to the outlet of the separator and a blood component collection bag connected to the second line for collecting a predetermined blood component separated by the centrifuge A blood component collection device including a circuit, comprising a control unit having a function of determining a blood collection speed based on information related to the blood donor.

  In this blood component collection device, the blood collection speed is determined by the control unit based on information related to the blood donor. That is, it is determined from the information about the blood donor whether the blood donor has a stable blood collection speed or is a blood donor with an unstable blood collection speed, and the blood collection speed optimum for the blood donor is determined. Therefore, in the case of a donor whose blood collection speed is stable, the blood collection (processing) time can be shortened by increasing the blood collection speed.

  In the blood component collection device according to the present invention, it is desirable that the control unit has a function of determining a blood collection rate based on a circulating blood volume determined by the blood donor.

  In this blood component collection device, the blood collection speed of the blood donor is determined by the control unit in accordance with the amount of circulating blood determined by the blood donor. Specifically, the blood collection speed is set to be high for blood donors with a large amount of circulating blood. This is because a donor with a large amount of circulating blood can increase the blood collection speed because the blood collection speed is stable. Conversely, the blood collection speed is not increased for blood donors with a small amount of circulating blood. Thereby, blood collection (processing) time can be shortened safely and reliably.

The circulating blood volume may be determined based on the donor's sex, height, and weight. Specifically, the circulating blood volume may be determined using the following “Fujita-Ogawa equation”.
Male: TBVm = 168H ³ + 50W + 444
Female: TBVf = 250H ³ + 63W−662
In the above formula, TBV: circulating blood volume (mL), H: height (m), W: body weight (kg).

  In the blood component collection device according to the present invention, it is desirable that the control unit has a function of determining a rotation speed of a rotor of the centrifuge based on the blood collection speed and the hematocrit value of the blood donor.

  When the blood collection speed is increased, the recovery rate of the collected blood components is reduced. Therefore, the final recovery rate is not reduced by determining the rotational speed of the centrifuge rotor based on the hematocrit value and blood collection speed of the blood donor. That is, when the blood collection speed can be increased, the final recovery rate is adjusted by setting the rotation speed of the rotor higher. Thereby, even if the blood collection speed is increased, the collected blood components can be prevented from causing unit breakage.

  Moreover, in the blood component collection device according to the present invention, the blood component collection circuit is connected to the plasma collection bag connected to the first line and the second line, and to the second line. It is desirable to have a platelet collection bag. This is because the blood collection (processing) time can be shortened safely and reliably, and platelets that meet the standards (not broken in units) can be collected.

  In the blood component collection device according to the present invention, it is desirable that the control unit has a function of calculating an expected platelet recovery rate based on the blood collection speed and the rotation speed of the centrifuge rotor. .

  As described above, increasing the blood collection rate decreases the platelet recovery rate, while increasing the rotation speed of the rotor increases the platelet recovery rate. The rate of increase in the platelet recovery rate due to the change in the rotational speed of the rotor is greater than the rate of decrease in the platelet recovery rate due to the change in the blood sampling rate. For this reason, when the blood collection rate can be increased, the platelet recovery rate increases as a result compared to the case of the normal blood collection rate. For this reason, a more accurate recovery rate can be calculated by calculating the platelet recovery rate based on the blood collection speed and the rotational speed of the rotor. Thereby, it is possible to know how much platelets can be collected before blood collection.

  According to the blood component collection device of the present invention, the blood collection time is set in the case of a blood donor whose blood collection speed is stable by setting the blood collection speed high within a predetermined range according to the sex, height, and weight of the blood donor. Can be shortened.

  DESCRIPTION OF EMBODIMENTS Hereinafter, a most preferred embodiment in which a blood component collection device of the present invention is embodied will be described in detail with reference to the drawings. First, a schematic configuration of the blood component collection device according to the present embodiment is shown in FIGS. FIG. 1 is a plan view showing a configuration example of a blood component collection circuit used in a blood component collection device, and FIG. 2 shows a state where a drive device is mounted on a centrifuge used in the blood component collection circuit. FIG. 3 is a fragmentary sectional view, and FIG. 3 is a conceptual diagram of the blood component collection device in a state where a blood component collection circuit is mounted. FIG. 4 is a block diagram showing a control system of the blood component collection device.

  The blood component collection device 1 according to the present embodiment is used as a platelet collection device for separating blood into a plurality of blood components by a centrifuge 20 having a blood storage space inside and collecting platelets in a bag. It is. The blood component collection apparatus 1 includes a first line 21 for connecting a blood collection means (blood collection needle 30) and the inlet of the centrifuge 20 and a second line connected to the outlet of the centrifuge 20. Blood comprising a line 22, a third line 23 connected to the first line 21, a plasma collection bag 25, a platelet collection bag 26, a multi-chamber bag 27 comprising an intermediate bag 28 and an air bag 29. A component sampling circuit 2 is mounted.

  In addition, the blood component collection device 1 includes a first liquid feeding pump 11 provided in the first line 21, a turbidity sensor 14 attached to the outlet of the centrifuge 20 or the second line 22, and air bubbles. It has a sensor 17. Furthermore, the blood component collection device 1 includes flow path opening / closing means 81 to 87 for switching the flow path of the blood component collection circuit 2.

  The blood component collection device 1 determines the maximum blood collection speed of the donor based on the circulating blood volume determined by the donor's sex, height, and weight, and centrifuges the blood to which the anticoagulant is added based on the maximum blood collection speed. A plasma collection step of collecting the separated plasma in the plasma collection bag 25 and collecting the separated plasma in the plasma collection bag 25, and a plasma circulation step of circulating the plasma in the plasma collection bag 25 collected in the plasma collection step to the centrifuge 20 At least one plasma collection / circulation step consisting of: and after the completion of the plasma collection / circulation step, the plasma circulation rate by the first liquid feeding pump 11 is accelerated to allow platelets to flow out from the centrifuge 20. A platelet collecting step of collecting platelets in the platelet collection bag 26, and after completion of the platelet collecting step, platelets for performing a blood return step of returning the blood in the centrifuge 20 As Preparative operation is performed, and controls the centrifugal separator drive unit 10, the first liquid supply pump 11, the second liquid supply pump 12, and a plurality of flow path shutter means 81 to 87.

  First, the blood component collection circuit 2 will be described. This blood component collection circuit 2 is a circuit for collecting platelets. As shown in FIG. 1, the blood component collection circuit 2 includes a centrifuge 20 that centrifuges blood, a first line 21 that is connected to the inlet 143 of the centrifuge 20, and a drain of the centrifuge 20. A second line 22 connected to the outlet 144, a third line 23 connected to the first line 21, a plasma collection bag 25, a platelet collection bag 26, an intermediate bag 28 and an airbag 29. A multi-chamber bag 27 is provided.

  The first line 21 includes a blood collection needle side first line 21 a to which the blood collection needle 30 is connected, and a centrifuge side first line 21 b connected to the inlet 143 of the centrifuge 20.

  The blood collection needle side first line 21a is formed by connecting a plurality of soft resin tubes. The blood collection needle side first line 21a includes a branch connector 21c for connection with the third line 23 from the blood collection needle 30 side, and a chamber 21d for removing bubbles and microaggregates. The other end of the blood collection needle side first line 21 a is connected to a branch connector 21 f for connection with the first tube 25 a of the plasma collection bag 25. The chamber 21d is connected to a filter 21i that is air permeable and impermeable to bacteria. Further, a clamp is attached between the blood collection needle 30 and the branch connector 21c of the blood collection needle side first line 21a.

  On the other hand, the centrifuge side first line 21b has a first pump tube 21g. The other end of the first centrifuge-side line 21b is connected to the connecting branch connector 21f.

  The second line 22 is connected from the centrifuge 20 side to a tube including the second tube 25b of the plasma collection bag 25, the sixth tube 29a of the airbag 29, and a breathable and bacteria-impermeable filter 22f. And a branch connector 22b for connection to the fourth tube 28a of the intermediate bag 28.

  One end of the third line 23 is connected to a connecting branch connector 21 c provided on the first line 21. The third line 23 includes a second pump tube 23a, a foreign matter removing filter 23b, a bubble removing chamber 23c, and an anticoagulant container connecting needle 23d from the branch connector 21c side.

  The plasma collection bag 25 is a container for collecting (storing) plasma. The plasma collection bag 25 includes a first tube 25a and a second tube 25b. The first tube 25a is connected to the branch connector 25c, one branched tube is connected to the branch connector 21f, and the other branched tube is connected to the branch connector 26b. On the other hand, the second tube 25 b is connected to the branch connector 22 b of the second line 22. Thus, a plasma collection branch line for collecting plasma is constituted by the plasma collection bag 25 and the second tube 25b. A clamp is attached to each of the first tube 25a and the second tube 25b.

  The platelet collection bag 26 is a container for collecting (storing) plasma containing platelets after passing through a leukocyte removal filter 261 described later. The platelet collection bag 26 includes a third tube 26a connected to a branch connector 26b for connecting the first tube 25a of the plasma bag 25 and the fifth tube 28b of the intermediate bag 28, and air in the bag via the tube 263a. And an air bag 262 for storing the air.

  In the following description, plasma containing platelets is referred to as “concentrated platelets”, and concentrated platelets collected (stored) in the platelet collection bag 26 are referred to as “platelet preparations”.

  A leukocyte removal filter 261 for separating and removing leukocytes (predetermined cells) from the concentrated platelets is installed in the middle of the third tube 26a. As the leukocyte removal filter 261, for example, a single layer of a porous body such as a woven fabric, a nonwoven fabric, or a foam made of a synthetic resin such as polyester or polyurethane in a casing having an inlet and an outlet at both ends, The thing etc. which inserted and comprised the filtration member laminated | stacked two or more layers can be used.

  Thus, the 3rd tube 26a is comprised by the two tubes 261a and 262a. The tube 261a connects the branch connector 26b and the leukocyte removal filter 261, and the tube 262a connects the leukocyte removal filter 261 and the platelet (platelet preparation) collection bag 26. Thereby, the third tube 26a (tubes 261a and 262a), the leukocyte removal filter 261, and the platelet collection bag 26 constitute a branch line for collecting platelets for collecting platelets (platelet preparation). A clamp is attached to each of the tube 262a connecting the platelet collection bag 26 and the leukocyte removal filter 261 and the tube 263a connecting the platelet collection bag 26 and the air bag 262.

  As described above, the first tube 25a of the plasma collection bag 25 is connected to the tube 261a located on the upstream side of the leukocyte removal filter 261 via the connection branch connector 26b. After the separation and removal, the plasma in the plasma collection bag 25 can be supplied to the leukocyte removal filter 261 and the platelets remaining in the leukocyte removal filter 261 can be collected in the platelet collection bag 26 together with the plasma. In other words, the plasma collection bag 25 has a line (first tube 25a) for supplying plasma to the leukocyte removal filter 261. Thereby, the plasma in the plasma collection bag 25 can be directly supplied to the branch line for collecting platelets without going through the multi-chamber bag 27.

  The leukocyte removal filter 261 and the air trap chamber 21d are fixed by the filter cassette housing 32. More specifically, the air trap chamber 21d provided in the first line 21, the connecting tube (Y-shaped tube) 262b of the leukocyte removal filter 261, the tube 261a and the tube 262a are integrated by the filter cassette housing 32. Has been.

  The multi-chamber bag 27 is formed by integrally forming an intermediate bag 28 and an air bag 29. The multi-chamber bag 27 is formed by completely separating the intermediate bag 28 and the air bag 29 by a partition wall 27a.

  The intermediate bag 28 is a container for temporarily storing concentrated platelets. The intermediate bag 28 includes a fourth tube 28a connected to the branch connector 25c and a fifth tube 28b connected to the branch connector 22b. On the other hand, the air bag 29 is a container for temporarily storing the air existing in the centrifuge 20 before blood collection. The airbag 29 includes a sixth tube 29a connected to the branch connector 22a.

  Here, each tube used for forming the above-described first to third lines 21 to 23, each pump tube 21g, 23a, and each tube 25a, 25b, 26a connected to each bag 25-27. , 28a, 28b and 29a are preferably polyvinyl chloride. 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. 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.) is used. Moreover, the same constituent material as each tube can be used also about the constituent material of each branch connector 21c, 21f, 22a, 22b, 25b, 26c mentioned above, respectively.

  As the plasma collection bag 25, the platelet collection bag 26, and the multi-chamber bag 27, a flexible sheet material made of resin is laminated, and the peripheral portions thereof are fused (heat fusion, high frequency fusion, ultrasonic fusion). Or the like, or a bag-like one bonded with an adhesive or the like. As a material used for each bag 25, 26, 27, for example, soft polyvinyl chloride is preferably used.

  The main part of such a blood component collection circuit 2 is a cassette type as shown in FIG. That is, the blood component collection circuit 2 includes each line (first line 21, second line 22, third line 23) and each tube (first tube 25a, second tube 25b, third tube 26a, 4 tube 28a, 5th tube 28b, 6th tube 29a) are partially accommodated, and they are hold | maintained partially, In other words, the main body cassette housing 31 to which they were partially fixed is provided. Each branch connector 21 f, 22 a, 22 b, 25 c, 26 b is housed in the main body cassette housing 31.

  The main cassette housing 31 includes six openings 91, 92, 93, 94, 95, 96, and 97 located in the housing. Specifically, the sixth tube 29 a of the air bag 29 is exposed and the first opening 91 capable of entering the first flow path opening / closing means 81 of the blood component collection device 1, and the fourth tube of the intermediate bag 28. 28a is exposed and the tube disposed between the second opening 92 and the branch connectors 21f and 25c through which the second flow path opening / closing means 82 of the blood component collection device 1 can enter is exposed, and the blood component The third opening 93 that allows the third flow path opening / closing means 83 of the collection device 1 to enter, the second tube 25b of the plasma collection bag 25 is exposed, and the fourth flow path opening / closing means of the blood component collection device 1 is exposed. The fourth opening 94 capable of entering 84 and the tube disposed between the branch connectors 26b and 25c are exposed, and the fifth flow path opening / closing means 85 of the blood component collection device 1 can be entered. 5 openings 95 The first line 21 on the blood collection needle side portion is exposed from the pump tube 21g, and the sixth opening 96 and the third tube 26a through which the sixth flow path opening / closing means 86 of the blood component collection device 1 can enter are exposed. And a fifth opening 97 through which the seventh channel opening / closing means 87 of the blood component collection device 1 can enter. Accordingly, when the main cassette housing 31 is mounted on the apparatus, the tube opening / closing means 81 to 87 provided in the blood component collection apparatus 1 can enter the openings 91 to 97 to open and close the tubes. Yes.

  The centrifuge 20 provided in the blood component collection circuit 2 is usually called a centrifuge bowl, and separates blood components by the specific gravity difference by centrifugal force. As shown in FIG. 2, the centrifugal separator 20 has a vertically extending pipe 141 having an inlet 143 formed at the upper end, and rotates around the pipe 141, and is liquid-tightly sealed with respect to the upper part 145. And a hollow rotor 142. The rotor 142 has a flow path (blood storage space) formed along the bottom and the inner surface of the peripheral wall, and an outlet 144 is formed so as to communicate with the upper portion of the flow path. In this case, the volume of the rotor 142 is, for example, about 100 to 350 ml. The rotor 142 is rotated under a predetermined centrifugal condition (rotational speed) 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 blood is separated from the inner layer into the plasma layer 131, the buffy coat layer 132, and the red blood cell layer 133 within the flow path of the rotor 142.

  Next, the blood component collection device 1 shown in FIGS. 3 and 4 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 for the first line 21, and a third line 23. A second liquid feed pump 12 for opening and closing, a plurality of flow path opening / closing means 81 to 87 for opening and closing a flow path of the blood component collection circuit 2, a centrifuge drive device 10, and a first liquid feed pump 11 The control part 13 for controlling the 2nd liquid feeding pump 12 and the some flow-path opening-and-closing means 81-87 is provided. Furthermore, the blood component collection device 1 is an optical type attached to the turbidity sensor 14 attached to the second line 22 located between the centrifuge 20 and the main body cassette housing 31 and the centrifuge 20. A sensor 15, a weight sensor 16 for detecting the weight of the plasma collection bag 25, and a bubble sensor 17 for detecting that plasma has overflowed from the centrifuge 20 are provided.

  As shown in FIG. 4, the control unit 13 includes a CPU 50, a pump controller 53 for the first liquid feed pump 11, and a pump controller 54 for the second liquid feed pump 12. The control unit 50, which is a control mechanism of the control unit 13, and the first liquid feeding pump 11 and the second liquid feeding pump 12 are electrically connected via pump controllers 53 and 54. Furthermore, the drive controller 55 provided in the centrifuge drive device 10 is also electrically connected.

  Also, the flow path opening / closing means 81, 82, 83, 84, 85, 86, 87 are all connected to the control unit 13, and their opening / closing is controlled by the control unit 13. Further, the turbidity sensor 14, the bubble sensor 17, the optical sensor 15 attached above the centrifuge 20, and the weight sensor 16 for detecting the weight of the plasma collection bag 25 are also electrically connected to the control unit 13. The signals output from them are input to the control unit 13. The control unit 13 has, for example, a control mechanism configured by a microcomputer, a calculation function for determining the maximum blood collection speed, the number of rotations of the rotor, and the like. The detection signal from the bubble sensor 17 is input to the control unit 13 as needed. Based on signals from the turbidity sensor 14, the optical sensor 15, the weight sensor 16, and the bubble sensor 17, the control unit 13 controls the rotation, stop, and rotation direction (forward / reverse rotation) of each pump and is necessary. Accordingly, the opening / closing of each channel opening / closing means and the operation of the centrifuge drive device 10 (rotation of the rotor) are controlled.

  The channel opening / closing means 81 to 87 include a line or tube insertion portion, and the insertion portion has a clamp that operates with a drive source such as a solenoid, an electric motor, or a cylinder (hydraulic pressure or air pressure). Specifically, a pneumatic cylinder clamp that operates by air pressure is suitable. The clamp of the channel opening / closing means operates based on a signal from the control unit 13.

  As shown in FIG. 2, the centrifuge drive device 10 holds a centrifuge drive device housing 151 that houses the centrifuge 20, a leg 152, a motor 153 that is a drive source, and the centrifuge 20. And a disk-shaped fixed base 155. The housing 151 is placed and fixed on the upper portion of the leg portion 152. A motor 153 is fixed to the lower surface of the housing 151 by a bolt 156 via a spacer 157. A fixed base 155 is fitted to the tip of the rotating shaft 154 of the motor 153 so as to rotate coaxially and integrally with the rotating shaft 154, and the bottom of the rotor 142 is fitted to the upper portion of the fixed base 155. A concave portion is formed. The upper portion 145 of the centrifuge 20 is fixed to the housing 151 by a fixing member (not shown). In the centrifuge drive device 10, when the motor 153 is driven, the fixed base 155 and the rotor 142 fixed thereto rotate, for example, at the number of rotations determined by the control unit 13 (for example, 4400 to 5200 rpm).

  Further, the position of the separated blood component interface (for example, the interface B between the plasma layer 131 and the buffy coat layer 132) in the centrifuge is optically detected on the inner wall of the centrifuge drive device housing 151. An optical sensor (interface sensor) 15 is installed and fixed by a mounting member 158. This sensor includes a light source that irradiates light toward the shoulder portion of the centrifuge 20 and a light receiving unit that receives light reflected from the centrifuge bowl and returning.

  That is, a light emitting element such as an LED or a laser and a light receiving element are arranged in a line, and the light reflected from the blood component of the light emitted from the light emitting element is received by the light receiving element, and the received light quantity is photoelectrically converted. It is configured. Since the intensity of the reflected light differs depending on the separated blood components (for example, the plasma layer 131 and the buffy coat layer 132), the position corresponding to the light receiving element where the amount of received light has changed is detected as the position of the interface B. More specifically, from the difference in the amount of light received at the light receiving unit when the light passing through the centrifuge 20 is a transparent liquid (plasma) and a blood cell such as a buffy coat or red blood cell. It is detected that the buffy coat layer has reached the light passage part. The position where the buffy coat layer is detected is adjusted by changing the position where the light passes through the bowl. Usually, once the light passing position is determined, the position is fixed.

  The turbidity sensor 14 is for detecting the turbidity of the fluid flowing in the second line 22 and outputs a voltage value corresponding to the turbidity. Specifically, a low voltage value is output when the turbidity is high, and a high voltage value is output when the turbidity is low. The platelet concentration is calculated from the output value of the turbidity sensor 14. The first liquid delivery pump 11 to which the pump tube 21g of the first line 21 is attached and the second liquid delivery pump 12 to which the pump tube 23a of the third line 23 is attached include a roller pump and a peristaltic pump. Non-blood contact type pumps such as are suitable. Further, as the first liquid feeding pump 11 (blood pump), a pump capable of feeding blood in any direction is used. Specifically, a roller pump capable of forward rotation and reverse rotation is used.

  The control unit 13 determines the maximum blood collection speed of the donor based on the circulating blood volume determined by the sex, height, and weight of the blood donor, and collects and collects the blood to which the anticoagulant is added based on the maximum blood collection speed. It comprises a plasma collection step for collecting blood and separating the separated plasma in the plasma collection bag 25 and a plasma circulation step for circulating the plasma in the plasma collection bag 25 collected in the plasma collection step to the centrifuge 20. At least one plasma collection / circulation step and after the completion of the plasma collection / circulation step, the plasma circulation rate by the first liquid feeding pump 11 is accelerated, and the platelets are discharged from the centrifuge 20 to remove the platelets. A platelet collection step for collecting the platelet in the collection bag 26 and performing a blood return step for returning the blood in the centrifuge 20 after the completion of the platelet collection step. As is done, the centrifugal separator drive unit 10, the first liquid supply pump 11, and controls the second liquid supply pump 12, and a plurality of flow path shutter means 81 to 87.

  Next, the platelet collection operation using the blood component collection apparatus 1 will be described with reference to the flowcharts shown in FIGS. 5 and 6 show the processing contents of the first to (n-1) cycles. 7 and 8 show the processing contents of the nth (final) cycle. FIG. 9 shows the details of the line cleaning process performed in the final cycle.

  First, the platelet collection operation in the first to n-1 cycles will be described with reference to FIGS. 5 and 6. First, the operator inputs the hematocrit value, sex, height, and weight of the blood donor (donor) to the blood component collection device 1 (S100A in FIG. 5). Then, the control unit 13 determines the centrifugal rotational speed (the rotational speed of the rotor 142), the blood collection speed (the upper limit value of the rotational speed of the first liquid feeding pump 11), the expected platelet recovery rate, and the number of platelet collection cycles. (S100B). Specifically, the centrifugal rotation speed is determined based on the hematocrit value of the blood donor. Further, the circulating blood volume is determined by the “Fujita-Ogawa equation” based on gender, height, and weight.

The "Fujita-Ogawa formula" is
Male: TBVm = 168H ³ + 50W + 444
Female: TBVf = 250H ³ + 63W−662
It is. In the above formula, TBV: circulating blood volume (mL), H: height (m), W: body weight (kg).

  Next, the blood collection speed is determined by the table shown in Table 1 based on the circulating blood volume. That is, in the case of a donor with a large amount of circulating blood, the blood collection speed is set high. Thereby, blood collection (processing) time can be shortened. In the past, the blood collection rate (upper limit) was set to 60 mL / min.

  Then, based on the centrifugal rotation speed and blood collection speed determined as described above, the predicted platelet recovery rate is determined by the table shown in Table 2. The platelet recovery rate determined here includes an increase / decrease (see Table 1) in the recovery rate due to a change in blood collection rate.

  That is, when the blood collection speed can be increased, the platelet collection efficiency is reduced as compared with the normal blood collection speed. On the other hand, when the blood collection speed can be increased, the centrifugal rotation speed is set higher, and the platelet recovery rate increases. The increase rate of the platelet recovery rate due to the change in the centrifugal rotation speed is larger than the decrease rate of the platelet recovery rate due to the change in the blood collection speed. For this reason, when the blood collection rate can be increased, the platelet collection rate increases as a result compared to the case of the normal blood collection rate.

  The required platelet count is a number that does not fall below the standard value (number of units) because it is determined by the standard. Therefore, when the blood collection rate can be increased, the number of platelets that do not break up can be ensured even if the platelet collection rate is set lower than that at the normal blood collection rate. That is, the target number of platelets can be collected in a shorter time by increasing the blood collection speed according to the physique of the blood donor (sex, height, and weight). The expected platelet recovery rate is calculated from the centrifugal rotation speed, and the expected platelet recovery rate is corrected by the increase / decrease amount of the platelet recovery rate according to the blood sampling rate (see Table 1) to calculate the final expected platelet recovery rate. You may do it.

  Thereafter, the number of cycles for collecting platelets is determined based on the predicted platelet recovery rate. Each value of the blood collection conditions determined in this way (in addition to those described above, for example, the expected blood collection time and the expected number of collected platelets) is indicated to the operator, and platelet collection is started. The contents will be described below. Note that the above-described processing (S100A and S100B in FIG. 5) is executed only in the processing of the first cycle.

  First, the third line 23 and the blood collection needle 30 are primed with an anticoagulant, and then the blood collection needle 30 is punctured into a blood donor (donor). Then, the centrifuge drive device 10 rotates the rotor 142 to perform a first plasma collection step of collecting a first predetermined amount of plasma from the blood into the plasma collection bag 25 (S101 in FIG. 5).

  Specifically, under the control of the control unit 13, the first liquid supply / closing means 81 and the sixth flow path opening / closing means 86 are opened, and the other liquid flow opening / closing means are closed, and the first liquid supply The pump 11 is operated (forward rotation) at the blood collection speed (about 60 to 85 mL / min) determined in the process of S100B, and blood collection is started from the donor.

  Simultaneously with this blood collection, the second liquid pump 12 is operated under the control of the control unit 13 to supply an anticoagulant such as an ACD-A solution via the third line 23, This anticoagulant is mixed into the collected blood. At this time, the rotation speed of the second liquid feeding pump 12 is adjusted by the control unit 13 so that the anticoagulant is mixed with the collected blood at a predetermined ratio (preferably about 1/20 to 1/6, for example 1/10) To be controlled.

  Thereby, blood (blood added with an anticoagulant) is transferred via the first line 21 and introduced into the blood storage space 146 of the rotor 142 through the tube 141 from the inlet 143 of the centrifuge 20. At this time, air (sterilized air) in the centrifuge 20 is sent into the airbag 29 via the second line 22 and the sixth tube 29a.

  At the same time as or before or after the blood collection, the control unit 13 operates the centrifuge drive device 10 to rotate the rotor 142 at the centrifugal rotation speed (about 4400 to 5200 rpm) determined in the process of S100B in FIG. Control to rotate with. As shown in FIG. 2, the blood introduced into the blood storage space 146 by the rotation of the rotor 142 is divided into a plasma layer (PPP layer) 131, a buffy coat layer (BC layer) 132, and a red blood cell layer (CRC layer) from the inside. It is separated into 133 layers. In the following steps, the control unit 13 does not change the rotation speed of the rotor 142 unless otherwise specified.

  Furthermore, when the blood collection and the supply of the anticoagulant are continued and blood (about 270 mL) exceeding the capacity of the blood storage space 146 is introduced into the blood storage space 146, the blood storage space 146 is completely filled with blood, Plasma (PPP) overflows from the outlet 144 of the centrifuge 20. At this time, the bubble sensor 17 installed in the second line 22 detects that the fluid flowing in the second line 22 has changed from air to plasma, and the control unit 13 detects the turbidity sensor 14. Based on the detection signal, control is performed so that the first flow path opening / closing means 81 is closed and the fourth flow path opening / closing means 84 is opened.

  As a result, plasma is introduced into and collected in the plasma collection bag 25 via the second line 22, the branch connectors 22a and 22b, and the second tube 25b. The weight of the plasma collection bag 25 is measured by the weight sensor 16, and the measured weight signal is input to the control unit 13.

  Here, during plasma collection, the control unit 13 determines whether or not the blood collection speed has decreased (S101A). If the blood collection speed decreases (S101A: YES), the centrifugal rotation speed is corrected, specifically, the centrifugal rotation speed is decreased. The centrifugal rotation speed may be corrected by the method disclosed in Japanese Patent Laid-Open No. 2001-170165.

  Next, the control unit 13 determines whether or not a predetermined amount of plasma has been collected in the plasma collection bag 25 based on the information (weight signal) from the weight sensor 16 (S102 in FIG. 5). The amount of plasma collected (predetermined amount) is preferably about 10 to 150 g, more preferably about 20 to 40 g.

  In S102, when a predetermined amount of plasma is not collected in the plasma collection bag 25 (S102: NO), the control unit 13 returns to the process of S101, and repeats the processes after S101 again. On the other hand, when a predetermined amount of plasma is collected in the plasma collection bag 25 in S102 (S102: YES), the control unit 13 circulates plasma (constant speed PPP circulation process) (S103).

  Specifically, under the control of the control unit 13, the sixth flow path opening / closing means 86 is closed, the third flow path opening / closing means 83 is opened, the second liquid feed pump 12 is stopped, and the first flow path opening / closing means 83 is stopped. The liquid feed pump 11 is operated (forward rotation) at a predetermined rotation speed (preferably about 60 to 250 mL / min, 200 mL / min in the present embodiment). As a result, the blood collection is temporarily interrupted, and the blood in the plasma collection bag 25 is stored via the first tube 25a, the branch connectors 25c and 21f, the first pump tube 21g, and the centrifuge-side first line 21b. Plasma introduced into the space 146 at a constant speed and flowing out from the outlet 144 of the centrifuge 20 is passed through the second line 22, branch connectors 22a and 22b, and the second tube 25b into the plasma collection bag 25. To collect. That is, the plasma in the plasma collection bag 25 is circulated in the blood storage space 146 at a constant speed.

  Next, the control unit 13 determines whether or not a predetermined time (preferably about 10 to 90 seconds, for example, 30 seconds) has elapsed since the start of constant-speed PPP circulation (S104 in FIG. 5). In S104, when the predetermined time has not elapsed since the start of the constant-speed PPP circulation (S104: NO), the control unit 13 returns to the process of S103 and repeats the processes after S103 again. On the other hand, when a predetermined time has elapsed since the start of the constant speed PPP circulation in S104 (S104: YES), the control unit 13 ends the constant speed PPP circulation process and performs the second plasma collection process. .

  In the second plasma collection step, blood is introduced into the blood storage space 146 of the rotor 142, and the plasma separated by centrifuging the blood is collected in the plasma collection bag 25. Specifically, first, the control unit 13 collects plasma (S105). At this time, the control unit 13 controls the third flow path opening / closing means 83 to be closed and the sixth flow path opening / closing means 86 to be opened. As a result, the amount of red blood cells in the blood storage space 146 increases, that is, as the layer thickness of the red blood cell layer 133 increases, the interface B also gradually rises (moves in the direction of the rotation axis of the rotor 142).

  Next, the control unit 13 determines whether the interface B has reached a predetermined level (first position) based on the detection signal (interface position detection information) from the optical sensor 15 (S106). The first position of the interface B is preferably the position at which the detection signal from the first optical sensor 15 (output voltage from the light receiving unit 152) is about 1 to 2V. .

  In S106, when the interface B has not reached the first position (S106: NO), the control unit 13 returns to the process of S105, and repeats the processes after S105 again. On the other hand, when the interface B reaches the first position in S106 (S106: YES), the control unit 13 ends the second plasma collection process and performs the accelerated plasma circulation process.

  In the accelerated plasma circulation step, the plasma in the plasma collection bag 25 is circulated while being accelerated into the blood storage space 146. Specifically, the control unit 13 circulates plasma (S107). That is, under the control of the control unit 13, the sixth flow path opening / closing means 86 is closed, the third flow path opening / closing means 83 is opened, the second liquid feed pump 12 is stopped, and the first flow path opening / closing means 83 is stopped. It operates (forward rotation) so that the rotational speed of the liquid feed pump 11 increases (increases) at a constant acceleration.

  As a result, the blood collection is temporarily interrupted, and the blood in the plasma collection bag 25 is stored via the first tube 25a, the branch connectors 25c and 21f, the first pump tube 21g, and the centrifuge-side first line 21b. The plasma introduced into the space 146 while accelerating and flowing out from the outlet 144 of the centrifuge 20 passes through the second line 22, the branch connectors 22a and 22b, and the second tube 25b into the plasma collection bag 25. To recover. That is, the plasma in the plasma collection bag 25 is circulated while being accelerated into the blood storage space 146.

  At this time, the controller 13 increases the rotation speed of the first liquid feed pump 11 at a constant acceleration from a speed slower than the constant speed PPP circulation (initial speed: 60 mL / min in the present embodiment). Control to increase. The acceleration condition (acceleration) is preferably about 1 to 10 mL / min / sec, more preferably about 3 to 6 mL / min / sec. Although the acceleration is constant in the present embodiment, it may be changed stepwise or continuously within the above range.

  Next, the control unit 13 determines whether or not the circulation speed of plasma into the blood storage space 146 has reached the maximum speed, that is, the rotation speed of the first liquid feeding pump 11 is the maximum speed (preferably 130 to 250 mL / min). In this embodiment, it is determined whether or not it has reached 170 mL / min (S108). The process of S108 is continued until the circulation speed of plasma into the blood storage space 146 reaches the maximum speed. In S108, when the circulation speed of plasma into the blood storage space 146 reaches the maximum speed (S108: YES), the control unit 13 ends the accelerated plasma circulation process and performs the third plasma collection process. .

  In the third plasma collection step, blood is introduced into the blood storage space 146 of the rotor 142, and the plasma separated by centrifuging the blood is collected in the plasma collection bag 25. Specifically, the control unit 13 first collects plasma (S109). Next, the control unit 13 determines whether or not a predetermined amount of plasma has been collected in the plasma collection bag 25 based on information (weight signal) from the weight sensor 16 (S110). The amount of plasma collected (predetermined amount) is preferably about 2 to 30 g, more preferably about 5 to 15 g.

  In S110, when a predetermined amount of plasma is not collected in the plasma collection bag 25 (S110: NO), the control unit 13 returns to the process of S109 and repeats the processes after S109 again. On the other hand, when a predetermined amount of plasma is collected in the plasma collection bag 25 (S110: YES), the control unit 13 ends the third plasma collection step and performs the platelet collection step (FIG. 6). (Transition to S111).

  In the platelet collection step, the plasma in the plasma collection bag 25 is circulated in the blood storage space 146 while being accelerated at the first acceleration, and then changed to a second acceleration larger than the first acceleration. The blood is circulated while accelerating at an acceleration of 2 to allow the platelets to flow out of the blood storage space 146, and the concentrated platelets are collected (stored) in the intermediate bag 27.

  In the platelet collecting step, first, the control unit 13 performs plasma circulation (PPP circulation) by the first acceleration (S111 in FIG. 6). Specifically, under the control of the control unit 13, the third flow path opening / closing means 83 is closed, the fourth flow path opening / closing means 84 is opened, the second liquid feeding pump 12 is stopped, and It operates (forward rotation) so as to increase (increase) the rotation speed of the first liquid feeding pump 11 at the first acceleration.

  As a result, the blood collection is temporarily interrupted, and the blood in the plasma collection bag 25 is stored via the first tube 25a, the branch connectors 25c and 21f, the first pump tube 21g, and the centrifuge-side first line 21b. The plasma introduced into the space 146 while accelerating and flowing out from the outlet 144 of the centrifuge 20 passes through the second line 22, the branch connectors 22a and 22b, and the second tube 25b into the plasma collection bag 25. To collect. That is, the plasma in the plasma collection bag 25 is circulated in the blood storage space 146 while being accelerated at the first acceleration.

  At this time, if plasma is circulated in the blood storage space 146 while accelerating at the first acceleration, the layer thickness of the red blood cell layer 133 increases, and the interface B gradually rises (moves in the direction of the rotation axis of the rotor 142). To do. The first acceleration is preferably about 0.5 to 10 mL / min / sec, more preferably about 1.5 to 2.5 mL / min / sec. Although the first acceleration is constant in the present embodiment, it may be changed stepwise or continuously within the above range. Further, the initial speed of the first liquid feed pump 11 in the PPP circulation by the first acceleration is preferably about 40 to 150 mL / min, more preferably about 50 to 80 mL / min. In the present embodiment, the initial speed of the first liquid feed pump 11 is set to 60 mL / min.

  Next, the control unit 13 continues step S111 until the circulating speed of plasma into the blood storage space 146 reaches a predetermined speed (S112). The plasma circulation speed, that is, the rotation speed of the first liquid delivery pump 11 is preferably about 100 to 180 mL / min, more preferably about 140 to 160 mL / min. In the present embodiment, the rotation speed of the first liquid feed pump 11 is 150 mL / min.

  In S112, when the circulation speed of plasma into the blood storage space 146 reaches a predetermined speed (S112: YES), the control unit 13 performs plasma circulation (PPP circulation) by the second acceleration (S113). ). Specifically, under the control of the control unit 13, the acceleration of the first liquid feed pump 11 is changed from the first acceleration to the second acceleration, and the rotation speed of the first liquid feed pump 11 is changed to the second speed. It operates (forward rotation) to increase (increase) at an acceleration of. Thereby, the plasma in the plasma collection bag 25 is circulated in the blood storage space 146 while being accelerated by the second acceleration.

  At this time, if plasma is circulated in the blood storage space 146 while accelerating at the second acceleration, the layer thickness of the red blood cell layer 133 increases, and the interface B gradually rises (moves in the direction of the rotation axis of the rotor 142). At the same time, the platelet (PC) in the buffy coat layer 132 rises (swells) against the centrifugal force and moves toward the discharge port 144 of the rotor 142. The second acceleration is set to be greater than the first acceleration, and is preferably about 3 to 20 mL / min / sec, more preferably about 5 to 10 mL / min / sec. Although the second acceleration is constant in the present embodiment, it may be changed stepwise or continuously within the above range.

  Next, the control unit 13 determines whether or not the circulating speed of plasma into the blood storage space 146 has reached the maximum speed, that is, the rotational speed of the first liquid feeding pump 11 is the maximum speed (preferably 120 to 300 mL / min). In this embodiment, it is determined whether or not it has reached 200 mL / min (S114). In S114, when the circulation speed of plasma into the blood storage space 146 has not reached the maximum speed (S114: NO), the control unit 13 returns to the process of S113, and repeats the processes after S113 again. On the other hand, when the circulation speed of plasma into the blood storage space 146 reaches the maximum speed in S114 (S114: YES), the control unit 13 performs plasma circulation continuation (PPP circulation continuation) (S115).

  Specifically, the control unit 13 controls to maintain (hold) the rotational speed of the first liquid feeding pump 11 at the maximum speed in S115. Thereby, the circulation speed of plasma into the blood storage space 146 is preferably about 120 to 300 mL / min. In this embodiment, it is set to 200 mL / min.

  Next, the control unit 13 determines whether or not a predetermined time (preferably about 5 to 15 seconds, for example, 10 seconds) has elapsed since the PPP circulation continuation was started (S116). In S116, when the predetermined time has not elapsed since the start of PPP circulation continuation (S116: NO), the control unit 13 then determines that the output voltage (PC concentration voltage) from the turbidity sensor 14 is a predetermined value. It is determined whether or not the voltage has decreased to (preferably about 2.5 to 3.5 V, for example, 3.0 V) or less (S117).

  In S117, when the output voltage from the turbidity sensor 14 has not decreased below the predetermined value (S117: NO), the control unit 13 returns to the process of S115 and repeats the processes after S115 again. Here, when S115 to S117 are repeated, and in S116, when a predetermined time has elapsed since the start of PPP circulation continuation (S116: YES), the control unit 13 ends the platelet collection step. On the other hand, in S117, when the output voltage from the turbidity sensor 14 falls below a predetermined value, that is, as the platelets flow out from the outlet 144 of the rotor 142, the plasma in the plasma flowing through the second line 22 When the platelet concentration reaches a predetermined value or more (S117: YES), the control unit 13 collects platelets (PC) (S118).

  Specifically, based on the detection signal of the turbidity sensor 14, the control unit 13 controls the fourth flow path opening / closing means 84 to be closed and the second flow path opening / closing means 82 to be opened. Thus, concentrated platelets are introduced into the intermediate bag 28 via the second line 22, the branch connectors 22a and 22b, and the fourth tube 28a, and collected (stored). At this time, since the seventh flow path opening / closing means 87 is closed, concentrated platelets do not flow out of the intermediate bag 28. Further, the control unit 13 calculates the platelet concentration (cumulative PC concentration) in the intermediate bag 28 based on the output voltage (detection signal) from the turbidity sensor 14. The platelet concentration continues to rise after the start of PC collection, and once it reaches the maximum concentration, it begins to fall.

  Next, the control unit 13 determines whether or not a predetermined time (preferably about 10 to 25 seconds, for example, 15 seconds) has elapsed since the start of PC collection (S119 in FIG. 6). In S119, when the predetermined time has not elapsed since the start of the PC sampling (S119: NO), the control unit 13 then reduces the output voltage (PC concentration voltage) of the turbidity sensor 14 to a predetermined value or less. It is determined whether or not it has been reached (S120). The predetermined value of the output voltage of the turbidity sensor 14 is a value near the time when red blood cells (CRC) are mixed in the plasma flowing through the second line 22, and is preferably about 0.5 V or less. .

  In S120, when the output voltage of the turbidity sensor 14 has not reached the predetermined value or less (S120: NO), the control unit 13 then determines whether or not the concentrated platelets in the intermediate bag 28 have reached the predetermined amount. Is determined (S121). The collection amount (predetermined amount) of the concentrated platelets is preferably about 20 to 100 mL, more preferably about 40 to 70 mL.

  In S121, when the concentrated platelets in the intermediate bag 28 do not reach the predetermined amount (S121: NO), the control unit 13 returns to the process of S118, and repeats the processes after S118 again. Here, while the processes of S118 to S121 are repeated, when the predetermined time has elapsed since the start of PC sampling in S119 (S119: YES), or in S120, the output voltage of the turbidity sensor 14 is When it reaches below the predetermined value (S120: YES), the control unit 13 ends the platelet collection step. In S121, also when the concentrated platelets in the intermediate bag 28 reach a predetermined amount (S121: YES), the control unit 13 ends the platelet collection process.

  Next, the blood component collection device 1 performs a step of stopping the centrifuge 20. In this step, first, the control unit 13 decelerates the centrifuge 20 (S124). Specifically, under the control of the control unit 13, the rotational speed of the centrifuge drive device 10 is decreased and the rotor 142 is decelerated. Further, the control unit 13 stops the centrifuge 20 (S125). Specifically, under the control of the control unit 13, the rotation of the centrifuge drive device 10 is stopped and the rotor 142 is stopped.

Next, the blood component collection device 1 performs a blood return process. In the blood return step, blood components in the blood storage space 146 of the rotor 142 are returned. In the blood return process, the control unit 13 returns blood (S126). Specifically, under the control of the control unit 13, the third flow path opening / closing means 83 is closed, the sixth flow path opening / closing means 86 is opened, and the first liquid feeding pump 11 is set to a predetermined rotational speed ( Preferably, it operates (reverses) at about 20 to 120 mL / min (for example, 90 mL / min).
As a result, blood components (mainly red blood cells) remaining in the blood storage space 146 of the rotor 142 are discharged from the inlet 143 of the centrifuge 20 and returned (returned) to the donor via the first line 21. Is done. The total amount of blood components (returned blood amount) is calculated from the amount of blood collected, the amount of plasma collected, and the amount of concentrated platelets collected.

  Then, under the control of the control unit 13, the first flow pump 11 is rotated the number of times necessary for returning the total amount of blood components (returned blood amount) to the donor, and then the sixth flow path opening / closing is performed. The means 86 is closed, and the first liquid feeding pump 11 is stopped to complete the blood return process.

  Thus, the platelet collection operation in the first cycle is completed. After that, among the above-described processes, the processes excluding S100A and S100B in FIG. 5 (that is, the processes after S101) are repeatedly performed, and the platelet collection operation after the second cycle (up to the n-1 cycle) is performed. . Therefore, for example, in the case of performing the platelet collection operation of 3 cycles, the platelet collection operation of the second cycle is performed according to the above-described processing. Note that how many platelet collection operations are performed is determined in the process of S100B.

  When the platelet collection operation up to the (n-1) th cycle is completed, the platelet collection operation of the nth cycle (final cycle) is performed. In the platelet collection operation in the final cycle, the same steps as those in the platelet collection operation in the second and subsequent cycles (up to the n-1 cycle) are performed except that a line washing step for washing the branch line for collecting platelets with plasma is performed. .

  That is, the first PPP collecting step (S101 to S102), the constant speed PPP circulating step (S103 to S104), the second PPP collecting step (S105 to S106), the accelerated PPP circulating step (S107 to S108), the third A PPP collection step (S109 to S110), a platelet collection step (S111 to S125), and a blood return step (S126) are performed. However, almost simultaneously with the second PPP collection step, the control unit 13 supplies the concentrated platelets temporarily collected (stored) in the intermediate bag 28 to the leukocyte removal filter 261 to filter the concentrated platelets. That is, the white blood cells in the concentrated platelets are separated and removed.

  Specifically, the seventh flow path opening / closing means 87 is opened under the control of the control unit 13. Thereby, the concentrated platelets in the intermediate bag 28 are transferred into the platelet collection bag 26 through the fifth tube 28b, the branch connector 26b, the tube 261a, the leukocyte removal filter 261, and the tube 262a by 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.

  The transfer of the concentrated platelets from the intermediate bag 28 to the platelet collection bag 26 may be performed using a pump. Further, the seventh flow path opening / closing means 87 may be a clamp or the like that can manually open and close the middle of the flow path of the tube 261a instead of the one operated by the control of the control unit 13.

  Next, the blood component collection device 1 performs a line washing process. In the line washing step, plasma is supplied from the plasma collection bag 25 to the platelet collection branch line, and the platelet collection branch line is washed. First, the blood component collection device 1 supplies the concentrated platelets temporarily collected (stored) in the intermediate bag 28 to the leukocyte removal filter 261 under the control of the control unit 13 to separate and remove the white blood cells in the concentrated platelets. The filtration operation is performed (S401 in FIG. 9). This filtration operation is started almost simultaneously with the start of the second plasma collection step in the platelet collection operation in the final cycle.

  Specifically, the filtration operation is performed according to the following procedure. That is, the seventh flow path opening / closing means 87 is opened under the control of the control unit 13. Thereby, the concentrated platelets in the intermediate bag 28 are transferred into the platelet collection bag 26 through the fifth tube 28b, the branch connector 26b, the tube 261a, the leukocyte removal filter 261, and the tube 262a by 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. Thus, leukocytes in the concentrated platelets are separated and removed. For this reason, leukocytes mixed in the platelet preparation are reduced.

  Almost simultaneously with this filtration operation, the second plasma collection step in the platelet collection operation in the final cycle is started (S402). At this time, the seventh flow path opening / closing means 87 located downstream of the intermediate bag 28 is opened. For this reason, the concentrated platelets collected in the second plasma collection step in the final cycle are sequentially supplied to the leukocyte removal filter 261 and filtered.

Subsequently, the plasma (PPP) supply amount is calculated by the control unit 13 based on the following equation (S403).
(PPP supply amount) = (Total amount of target platelet preparation) − (PC collection amount)
Here, the total amount of the target platelet preparation is calculated from the expected platelet recovery rate determined in S100B of FIG. Further, the PC collection amount is determined by the total number of rotations of the first liquid feeding pump 11 when the second flow path opening / closing means 82 is opened.

  When calculating the PPP supply amount, the control unit 13 supplies plasma (PPP supply) to the platelet collection branch line (S404 in FIG. 9 and S227 in FIG. 8). Specifically, under the control of the control unit 13, the second flow path opening / closing means 82, the fourth flow path opening / closing means 84, and the seventh flow path opening / closing means 87 are opened, and the first liquid feed pump 11. And the rotational speed of the rotor 142 are changed.

  The rotation speed of the second liquid feeding pump 11 is preferably about 250 mL / min or less, more preferably about 40 to 250 mL / min. Further, the rotational speed of the rotor 142 is set to be, for example, about 300 to 800 rpm higher than the rotational speed of the rotor 142 in each step of the plasma collection operation in the final cycle, and specifically, about 5000 to 5500 rpm is preferable. .

  Thereby, first, the plasma in the plasma collection bag 25 is converted into the first tube 25a, the branch connectors 25c and 21f, the first pump tube 21g, the first line 21b of the centrifuge, and the rotor 142 (centrifuge 20). Then, it is transferred to the intermediate bag 28 through the second line 22, the branch connectors 22a and 22b, and the fourth tube 28a. Then, the plasma transferred to the intermediate bag 28 is introduced (supplied) into the platelet collection bag 26 via the fifth tube 28b, the branch connector 26b, the tube 261a, the leukocyte removal filter 261, and the tube 262a.

  At this time, platelets remaining in the leukocyte removal filter 261 and the flow path of the tube 262a (concentrated platelets after separating and removing leukocytes) are collected in the platelet collection bag 26 together with plasma, so that the platelets in the platelet preparation The yield of can be increased. Moreover, by supplying plasma through the intermediate bag 28, the plasma is supplied to the leukocyte removal filter 261 together with the concentrated platelets remaining in the intermediate bag 28 and in the flow path of the tube 261a. The yield of platelets can be further improved.

  Thus, in the washing step, the total amount of the platelet preparation (blood component in the platelet collection bag 26) is adjusted by the supply amount of plasma. Thereby, the operation of adjusting the total amount of the platelet preparation can be omitted separately. Further, since such adjustment can be performed in the blood component collection circuit 2 (closed state), there is also an advantage that a sterile state can be maintained. The supply amount of such plasma is preferably about 5 to 200 mL, more preferably about 12 to 150 mL. The plasma supply amount is detected by the weight sensor 16 as a change (decrease) in the weight of the plasma collection bag 25.

  Then, based on the detection signal of the weight sensor 16, the control unit 13 determines whether or not the supply amount (set amount) of plasma calculated in S403 has been supplied into the intermediate bag 28 (S405 in FIG. 9). . At this time, if the set amount has not been reached (S405: NO), the supply of plasma is continued (S404). On the other hand, when the set amount is reached (S405: YES), the control unit 13 closes the second flow path opening / closing means 82 and the seventh flow path opening / closing means 87, and the first liquid feeding pump 11 is turned off. Control to stop. Thereafter, the platelet preparation is collected (S406). Thus, the line cleaning process is completed.

  Thus, in blood component collection device 1 according to the present embodiment, the blood collection speed is set to be higher for blood donors (blood donors whose blood collection speed is stable) whose blood collection speed can be set high. Since the platelet collection operation is performed, the blood collection time can be shortened. In addition, since the platelet recovery rate, which is decreased by increasing the blood collection speed, is adjusted by changing the centrifugal rotation speed, it is possible to collect platelets so as not to cause unit breakage.

  A device composed of two blood pumps (first liquid pump) and anticoagulant pump (second liquid pump) with the circuit configuration shown in FIG. did. A comparative experiment was conducted for the same donor (male, height 170 cm, body weight 75 kg) with an interval of 2 weeks. The comparison of the evaluated operation flow is shown below. The platelet count of the obtained thick platelets was measured with a blood component measuring device (trade name: Sysmex (R) XE-2100). The amount of collected platelets was 200 mL. In the platelet collection step, the initial circulation speed was 60 mL / min and the circulation acceleration was 2 mL / min / sec.

  The blood collection speed was calculated to be 85 mL / min, the centrifugal rotation speed was 5000 rpm, and the platelet collection operation was calculated to be 3 cycles. The expected platelet recovery rate was calculated as 75%. The blood collection speed is constant-speed plasma circulation conditions (200 mL / min, 30 sec) performed after the total plasma volume reaches 30 g, accelerated plasma circulation conditions (initial speed 60 mL / min, arrival speed 170 mL / min, acceleration performed after BC interface detection) Conditions were 5 mL / min / sec, acceleration time 22 sec).

(Comparative example)
Blood collection rate is 60 mL / min, constant-speed plasma circulation conditions (200 mL / min, 30 sec) performed after the total plasma volume reaches 30 g, accelerated plasma circulation conditions (initial speed 60 mL / min, arrival speed 170 mL / min, performed after BC interface detection, The acceleration conditions were 5 mL / min / sec and the acceleration time was 22 sec. The platelet collection operation was performed 3 times, and the centrifugal rotation speed was 5000 rpm.

(Experimental result)
When platelet collection was performed according to Examples and Comparative Examples, the results shown in Table 3 were obtained.

  As is apparent from Table 1, the platelet recovery rate in the example was lower than that in the comparative example, but the same number of platelets as in the comparative example could be collected. In other words, the target number of platelets could be collected without causing a unit break. The processing time required to obtain the platelets was 35 minutes in the example and 41.4 minutes in the comparative example. Therefore, in the example, the processing time could be shortened by 6.4 min. As described above, according to the embodiment, the blood collection speed can be increased to shorten the processing time, and the target platelet count can be collected.

  It should be noted that the above-described embodiment is merely an example and does not limit the present invention in any way, and various improvements and modifications can be made without departing from the scope of the invention. For example, the conditions in each step of the platelet collection operation shown in the above-described embodiment can be set as appropriate, and arbitrary steps can be added and / or omitted as necessary. The optical sensor shown in the above embodiment is not limited to the illustrated one, and may be a line sensor, for example.

It is a top view which shows the structural example of the blood component collection circuit used for the blood component collection apparatus which concerns on this Embodiment. FIG. 2 is a partially broken cross-sectional view showing a state in which a drive device is mounted on a centrifuge used in the blood component collection circuit shown in FIG. 1. It is a conceptual diagram of the blood component collection device which concerns on this Embodiment in the state which mounted | wore the blood component collection circuit shown in FIG. It is a block diagram which shows the control system of the blood component collection device which concerns on this Embodiment. It is a flowchart which shows the processing content of the 1st-(n-1) cycle in platelet collection operation. It is a flowchart which shows the processing content of the 1st-(n-1) cycle in platelet collection operation. It is a flowchart which shows the processing content of the nth (final) cycle in platelet collection operation. It is a flowchart which shows the processing content of the nth (final) cycle in platelet collection operation. It is a flowchart which shows the processing content of the line washing | cleaning performed by nth (final) cycle.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Platelet collection apparatus 2 Blood component collection circuit 10 Centrifugal drive device 11 1st liquid feeding pump 12 2nd liquid feeding pump 13 Control part 14 Turbidity sensor 20 Centrifuge 21 1st line 22 2nd line 23 Third line 25 Plasma collection bag 26 Platelet collection bag 27 Multi-chamber bag 28 Intermediate bag 29 Air bag 30 Blood collection needle 50 CPU
81-87 Channel opening / closing means 142 Rotor

Claims (6)

A centrifuge having a rotor having a blood storage space therein, an inlet and an outlet communicating with the blood storage space, and centrifuging blood introduced from the inlet by rotation of the rotor in the blood storage space When,
A first line connecting blood collection means for collecting blood from a donor and the inlet of the centrifuge;
A second line connected to the outlet of the centrifuge;
A blood component collection device comprising a blood component collection circuit having a blood component collection bag connected to the second line and collecting a predetermined blood component separated by the centrifuge;
A blood component collection device comprising a control unit having a function of determining a blood collection rate based on information on the blood donor. In the blood component collection device according to claim 1,
The control unit has a function of determining a blood collection speed based on a circulating blood volume determined by the blood donor. In the blood component collection device according to claim 2,
The blood component collection apparatus, wherein the control unit determines the circulating blood volume based on the sex, height, and weight of the blood donor. The blood component collection device according to any one of claims 1 to 3,
The control unit has a function of determining a rotation speed of a rotor of the centrifuge based on the blood collection speed and the hematocrit value of the blood donor. The blood component collection device according to any one of claims 1 to 4,
The blood component collection circuit includes a plasma collection bag connected to the first line and the second line, and a platelet collection bag connected to the second line. circuit. In the blood component collection device according to claim 5,
The control unit has a function of calculating an expected platelet recovery rate based on the blood collection speed and the rotation speed of a rotor of the centrifuge.

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