WO2013145374A1 - 血液成分分離装置 - Google Patents

血液成分分離装置 Download PDF

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Publication number
WO2013145374A1
WO2013145374A1 PCT/JP2012/073197 JP2012073197W WO2013145374A1 WO 2013145374 A1 WO2013145374 A1 WO 2013145374A1 JP 2012073197 W JP2012073197 W JP 2012073197W WO 2013145374 A1 WO2013145374 A1 WO 2013145374A1
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WO
WIPO (PCT)
Prior art keywords
blood
blood component
predetermined
platelet
concentration
Prior art date
Application number
PCT/JP2012/073197
Other languages
English (en)
French (fr)
Japanese (ja)
Inventor
重幸 木村
Original Assignee
テルモ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Priority to JP2014507311A priority Critical patent/JP6081448B2/ja
Priority to CN201280071779.5A priority patent/CN104203302B/zh
Publication of WO2013145374A1 publication Critical patent/WO2013145374A1/ja

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3693—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits using separation based on different densities of components, e.g. centrifuging
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3693—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits using separation based on different densities of components, e.g. centrifuging
    • A61M1/3696—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits using separation based on different densities of components, e.g. centrifuging with means for adding or withdrawing liquid substances during the centrifugation, e.g. continuous centrifugation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/38—Removing constituents from donor blood and storing or returning remainder to body, e.g. for transfusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/02—Blood transfusion apparatus
    • A61M1/0209—Multiple bag systems for separating or storing blood components
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/04—Liquids
    • A61M2202/0413—Blood
    • A61M2202/0427—Platelets; Thrombocytes

Definitions

  • the present invention relates to a blood component separation device for collecting a predetermined blood component from blood. More specifically, the present invention relates to a blood component separation device that collects a predetermined amount of a predetermined blood component in each cycle.
  • component blood collection is performed in which only platelets are collected and other components are returned to the blood donor.
  • a blood component separation apparatus equipped with a centrifuge is used.
  • the platelet liquid flowing out from the centrifuge has a low concentration first, then a high concentration, and finally a low concentration again.
  • the concentration of the platelet liquid stored in the platelet intermediate bag inevitably decreases.
  • the first and last low-concentration platelet solutions are temporarily stored in a buffy coat bag, and the whole blood collected from the supplier during the second cycle. Mix and flow into centrifuge. By repeating this, only a high-concentration platelet solution can be stored in the platelet intermediate bag.
  • the blood component separation apparatus based on the concentration of platelet fluid flowing out from the centrifuge (value of the line sensor), it starts to store platelet fluid in the platelet intermediate bag when a certain concentration is reached, Thereafter, when the concentration drops to a certain concentration, the platelet liquid is stored in the intermediate platelet bag.
  • the amount of platelet liquid stored in the intermediate platelet bag is determined based on the value of the line sensor, it varies depending on the blood count value of the donor. Therefore, there has been a problem that the amount of platelet fluid collected per cycle cannot be controlled to a constant amount, and the amount of platelet fluid finally collected after multiple cycles varies.
  • the present invention has been made to solve the above-described problems, and controls the collection timing of a predetermined blood component to control the collection amount of the predetermined blood component per cycle to a constant amount. It is an object of the present invention to provide a blood component separation apparatus capable of performing the above.
  • One aspect of the present invention made to solve the above problems includes a centrifuge for separating a plurality of predetermined blood components from blood, and a container for storing the centrifuged predetermined blood components.
  • the metering pump is driven to collect a predetermined amount of the predetermined blood component in the sampling step of the predetermined blood component. The time for collecting the predetermined blood component from the centrifuge is controlled.
  • the time for collecting the predetermined blood component is controlled by driving the metering pump so that the predetermined blood component is collected in a predetermined amount. Therefore, the collection amount of the predetermined blood component per cycle can be controlled to a constant amount. Therefore, a predetermined amount of a predetermined blood component can be finally secured after a plurality of cycles, and thereafter, the concentration of the predetermined blood component can be easily adjusted.
  • the concentration of the predetermined blood component at each timing of flowing out from the centrifuge is equal at the sampling start timing and end timing in the predetermined blood component sampling step. Determining the start timing of the predetermined blood component collection process from the blood count value of the blood donor based on the blood count value stored in advance or the map data relating to the concentration of the predetermined blood component. preferable.
  • the blood component flowing out of the centrifuge gradually increases when the outflow starts and gradually decreases when the maximum flow rate is exceeded.
  • concentration of the blood component that flows out gradually increases from a low concentration to a high concentration, and gradually decreases after the concentration peak.
  • Such blood component outflow curves have individual differences, but based on the blood counts of the supplier, it is possible to estimate what kind of outflow curve the blood donor will have.
  • the predetermined blood component concentration is stored in advance so that the concentration at the start timing and the end timing of the sampling in the sampling process of the predetermined blood component are equal to each other at each timing of flowing out from the centrifuge.
  • the start timing of the sampling process is determined from the blood count value of the supplier. Therefore, when collecting a predetermined amount of a predetermined blood component, it is possible to accurately select a period during which the concentration of the blood component is high. Thereby, since the collection timing of a predetermined blood component having a high concentration can be optimized, a larger number of predetermined blood components can be collected.
  • the blood count value when the predetermined blood component is platelet liquid, the blood count value may be a hematocrit value or a platelet count.
  • the start timing of the predetermined blood component collection step after the second cycle may be corrected based on the start timing and end timing of the predetermined blood component collection step in the immediately preceding cycle.
  • the collection process in the second and subsequent cycles so as to eliminate the deviation It is possible to correct the timing for starting the operation. Therefore, in the second cycle and thereafter, the collection timing of a predetermined blood component having a high concentration can be further optimized, so that a larger number of predetermined blood components can be collected.
  • the start timing of the predetermined blood component collection process in the second cycle and thereafter is determined based on the predetermined blood component concentration at the start of the predetermined blood component collection process in the immediately preceding cycle and the predetermined time at the end. It is preferable to correct when the average value of the blood component concentration is reached.
  • a centrifuge step for introducing whole blood collected from a blood donor into a centrifuge and separating it into a plurality of blood components; and b) among the centrifuge blood components, A circulation flow step of introducing a first blood component of the predetermined blood components separated by the centrifugation together with whole blood into the centrifuge; c) a predetermined amount of the first blood component in the circulation flow step; After separating one blood component, the supply of whole blood to the centrifuge is stopped, and only the first blood component is introduced into the centrifuge and further circulated for a predetermined time, and then the circulation speed is accelerated.
  • a predetermined blood component can be accurately separated from other blood components. Since the collection timing of a predetermined blood component having a high concentration is optimized, a larger number of predetermined blood components can be collected efficiently.
  • the circulation / acceleration step includes a first collection step of transferring a second blood component having a low concentration among the second blood components to a temporary storage container; A second collection step of collecting a high-concentration second blood component among the blood components, and the low-concentration second blood component transferred to the temporary storage container was collected in the next cycle It may be introduced into the centrifuge together with whole blood.
  • the blood component separation apparatus described above has a whole blood bag for storing whole blood collected from a blood donor, and the whole blood stored in the whole blood bag is collected in the next cycle in the centrifugation step of the next cycle. It may be introduced into the centrifuge together with the whole blood.
  • the whole blood is collected from the donor in parallel. Since it can be collected, the whole blood collection time in the second cycle (next cycle) can be shortened, the entire processing time can be shortened, and the time burden on the blood donor can be reduced.
  • circulation flow process critical flow process
  • circulation process is 30-40 seconds
  • circulation / acceleration process is accelerated
  • the process is 20 to 30 seconds
  • the blood return time is about 4 minutes.
  • the blood collection time in the second cycle can be shortened by 1 minute to about 8 minutes.
  • the blood collection time of the 3rd cycle can be shortened by 1 minute to about 8 minutes.
  • the changeover switch can collect whole blood in parallel with the circulation / acceleration process of the first cycle (current cycle). The whole blood may be collected in the second cycle (next cycle) after returning the blood.
  • the whole blood bag may be used as a temporary storage container.
  • next cycle centrifugation step it is preferable to further include a pump for introducing the whole blood or / and the second blood component stored in the temporary storage container in the previous cycle into the centrifuge.
  • the collection timing of a predetermined blood component per cycle can be controlled to a constant amount by controlling the sampling timing of the predetermined blood component.
  • FIG. It is a figure which shows the structure of the blood component separation apparatus of Example 1.
  • FIG. It is a block diagram which shows the control system of the blood component separation apparatus which concerns on embodiment. It is a figure which shows the structure of a centrifuge bowl.
  • 3 is a flowchart illustrating the operation of the blood component separation device according to the first embodiment. It is a flowchart which shows the effect
  • FIG. It is a figure which shows a 2nd process (centrifugation process). It is a figure which shows a 3rd process (critical flow process).
  • FIG. 6 is a flowchart illustrating the operation of the blood component separation device according to the second embodiment. It is a figure which shows the blood collection process of the blood component separation apparatus of Example 2. FIG. It is a figure which shows the circulation process of the blood component separation apparatus of Example 2. FIG. It is a figure which shows PC collection process of the blood component separation apparatus of Example 2.
  • FIG. 1 shows the system configuration of the blood component separation device according to the first embodiment.
  • FIG. 2 is a block diagram illustrating a control system of the blood component separation device according to the embodiment.
  • the blood component separation device includes a blood component separation circuit 1.
  • the blood component separation circuit 1 has a primary blood collection circuit 5 including a blood collection needle 2, a primary blood collection bag Y7 for collecting primary blood, a sampling port 3, and a primary blood collection line 4.
  • the blood component separation circuit 1 has a centrifuge bowl E1.
  • the centrifuge bowl E1 has a rotor (not shown) having a blood storage space inside the collection, rotation driving means 14 for rotating the rotor, an inlet (first port E1a), and an outlet (second port E1b).
  • the blood is separated into a plurality of blood components by the rotation of the rotor.
  • the blood component separation circuit 1 stores a blood component separated by the centrifuge bowl E1, a first container (plasma bag) Y1, a second container (temporary storage bag) Y2, and a third container (platelet intermediate bag). Y3.
  • the blood component separation circuit 1 has a first line, a second line, a third line, a fourth line, a fifth line, a sixth line, and a seventh line.
  • the first line is for connecting the blood collection needle 2 and the centrifuge bowl E1, and from the donor tube T1, the first blood pump P1, the tube T2, the tube T3a, the first on-off valve V1, the tube T3b, and the tube T4. Composed.
  • the second line is for connecting the centrifuge bowl E1 and the first container Y1, and includes a tube T5, a tube T6a, a second on-off valve V2, and a tube T6b.
  • the third line is for connecting the first container Y1 and the first line.
  • the fourth line is for connecting the centrifuge bowl E1 and the second container Y2, and includes a tube T5, a tube T15, a tube T11a, a fifth on-off valve V5, and a tube T11b.
  • the fifth line is for connecting the second container Y2 and the first line, and includes a tube T12, a tube T13b, a sixth on-off valve V6, and a tube T13a.
  • the sixth line is for connecting the second container Y2 and the first line in the same manner as the fifth line.
  • the seventh line is for connecting the centrifuge bowl E1 and the third container Y3 and includes a tube T5, a tube T15, a tube T16, a tube T17a, an eighth on-off valve V8, and a tube T17b.
  • a blood collection needle 2 which is a collection means for collecting whole blood (blood) from a donor, is connected to the first port of the first blood pump P1 by a donor tube T1.
  • the first blood collection bag Y7 is connected to a blood collection needle through a first blood collection line 4 from a branch portion provided on the donor tube T1.
  • the initial blood collection bag Y7 further includes a sampling port 3 for transferring the collected initial blood to a test container (not shown).
  • the sampling port 3 includes a main body portion, a needle portion 6, and a cover portion 7 that covers the needle portion. Consists of. Further, a clamp 8 for opening and closing the line is provided on the initial blood collection line.
  • the tube T2 connected to the second port of the first blood pump P1 is branched into two tubes T3a and T13a.
  • the tube T3a is connected to the first port of the first on-off valve V1, and the first on-off valve V1 is connected to the first port.
  • the 2 ports are connected to the tube T3b.
  • the tube T3b is branched into two tubes T4 and T10a, and the tube T4 is connected to a first port E1a of a centrifuge bowl E1 that is a centrifuge for separating the collected blood into a plurality of blood components.
  • the centrifuge bowl E1 is disposed on the rotation driving means 14 and is driven to rotate.
  • the blood collection needle 2 and the first port E1a on the inlet side of the centrifuge bowl E1 are connected to the first line (donor tube T1, first blood pump P1, tube T2, tube T3a, first on-off valve V1, tube). T3b and tube T4) are connected.
  • the pressure sensor C1 is connected to the donor tube T1.
  • the tube T5 connected to the second port E1b of the centrifuge bowl E1 is branched into a tube T15 and a tube T6a.
  • the tube T6a is connected to the first port of the second on-off valve V2, and the second port of the second on-off valve V2 is connected to the tube T6b.
  • the tube T6b is connected to the second port Y1b of the plasma bag (first container) Y1.
  • the second port E1b of the centrifuge bowl E1 and the plasma bag Y1 are connected by a second line (tube T5, tube T6a, second on-off valve V2, tube T6b). Note that there are two plasma bags Y1, which are omitted in FIGS.
  • the first port Y1a on the output side of the plasma bag Y1 is connected to the tube T8a.
  • the tube T8a is connected to the first port of the third on-off valve V3.
  • the second port of the third on-off valve V3 is connected to the tube T8b, and the tube T8b is connected to the tube T9.
  • the tube T9 is connected to the second port of the second blood pump P2.
  • the first port of the second blood pump P2 is connected to the tube T10b, and the tube T10b is connected to the second port of the fourth on-off valve V4.
  • the first port of the fourth on-off valve V4 is connected to the tube T10a.
  • the tube T10a is connected to an intermediate position between the tube T3b and the tube T4 constituting the first line. That is, the plasma bag Y1 and the first line are connected by a third line (tube T8a, third on-off valve V3, tube T8b, tube T9, second blood pump P2, tube T10b, fourth on-off valve V4, tube T10a). It is connected. Thereby, the plasma bag Y1 is connected so as to selectively communicate with the inlet side or the outlet side of the centrifuge bowl E1.
  • the tube T15 branched from the tube T5 is further branched into a tube T11a and a tube T16.
  • the tube T11a is connected to the first port of the fifth on-off valve V5, and the second port of the fifth on-off valve V5 is connected to the tube T11b.
  • the tube T11b connects to the second port Y2b of the temporary storage bag Y2. That is, the second port E1b of the centrifuge bowl E1 and the temporary storage bag Y2 are connected by the fourth line (tube T5, tube T15, tube T11a, fifth on-off valve V5, tube T11b).
  • the first port Y2a of the temporary storage bag Y2 is connected to the tube T12 and branches into the tube T13b and the tube T14a.
  • the tube T13b is connected to the first port of the sixth on-off valve V6, and the second port of the sixth on-off valve V6 is connected to the tube T13a.
  • the tube T13a is connected to an intermediate position between the tube T2 and the tube T3a constituting the first line.
  • the tube T14a branched from the tube T12 is connected to the first port of the seventh on-off valve V7, and the tube T14b is connected to the second port of the seventh on-off valve V7.
  • the tube T14b is connected to an intermediate position between the tube T9 and the tube T8b, and the tube T9 is connected to the second port of the second blood pump P2.
  • the first port of the second blood pump P2 is connected to the tube T10b, and the tube T10b is connected to the first port of the fourth on-off valve V4.
  • the second port of the fourth on-off valve V4 is connected to the tube T10a.
  • the tube T10a is connected to an intermediate position between the tube T3b and the tube T4 constituting the first line. That is, the temporary storage bag Y2 and the first line are the fifth line (tube T12, tube T13b, sixth open / close valve V6, tube T13a), and sixth line (tube T12, tube T14a, seventh open / close valve V7, Tube T14b, tube T9, second blood pump P2, tube T10b, fourth open / close valve V4, and tube T10a).
  • Temporary storage bag Y2 is connected to selectively communicate with the inlet side or outlet side of centrifugal bowl E1.
  • the tube T16 branched from the tube T15 is further branched into two tubes T17a and T18a.
  • the tube T17a is connected to the first port of the eighth on-off valve V8, and the second port of the eighth on-off valve V8 is connected to the tube T17b.
  • the tube T17b is connected to the first port Y3a on the input side of the platelet intermediate bag (third container) Y3.
  • the tube T18a branched from the tube T16 is connected to the first port of the ninth on-off valve V9, and the second port of the ninth on-off valve V9 is connected to the tube T18b.
  • the tube T18b is connected to the airbag Y4.
  • the second port E1b of the centrifugal bowl E1 and the platelet intermediate bag Y3 are connected by a seventh line (tube T5, tube T15, tube T16, tube T17a, eighth on-off valve V8, tube T17b).
  • the platelet intermediate bag Y3 is connected to communicate with the outlet side of the centrifuge bowl E1.
  • a turbidity sensor C2 and a pressure sensor C3 for detecting the concentration of platelets are attached to a tube T5 connected to the second port E1b of the centrifugal bowl E1.
  • the turbidity sensor C2 detects the degree to which the plasma passing through the tube T5 becomes turbid with platelets.
  • an interface sensor C4 for detecting the interface position of the buffy coat layer BC (see FIG. 3) formed in the centrifugal bowl E1 is attached to the peripheral portion where the centrifugal bowl E1 is attached.
  • the tenth on-off valve V10 is connected to the first port and the tenth on-off valve T10a is connected to the first port.
  • the second port of the valve V10 is connected to the tube T20b.
  • the tube T21 is connected to the first port that is the output side of the third blood pump P3.
  • the second port on the input side of the third blood pump P3 is connected to the platelet preservation solution bottle by the bottle needle 10 via the sterilizing filter 9.
  • the tube T20b is connected to the platelet bag Y5 via the leukocyte removal filter 11.
  • an airbag Y6 is connected to the platelet bag Y5.
  • the output port of the ACD pump P4 is connected in the middle of the donor tube T1.
  • the input port of the ACD pump P4 is connected to the output port of the sterilization filter 12.
  • the input port of the sterilization filter 12 is connected to the ACD storage bottle by the bottle needle 13.
  • the control unit 15 is configured by, for example, a microcomputer, and includes a first blood pump P1, a second blood pump P2, a third blood pump P3, an ACD pump P4, and a centrifugal bowl drive device. 14, pressure sensor C1, turbidity sensor C2, pressure sensor C3, interface sensor C4, first on-off valve V1, second on-off valve V2, third on-off valve V3, fourth on-off valve V4, fifth on-off valve V5, first The sixth on-off valve V6, the seventh on-off valve V7, the eighth on-off valve V8, the ninth on-off valve V9, and the tenth on-off valve V10 are electrically connected.
  • the detection signals from the sensors C1, C2, C3, and C4 are input to the control unit 15 as needed.
  • the control unit 15 controls the operation / stop, rotation direction (forward / reverse rotation) and rotation speed of each pump P1, P2, P3, and P4 based on these detection signals and the like, and each on-off valve as necessary. Controls the opening / closing of V1, V2, V3, V4, V5, V6, V7, V8, V9, V10 and the operation of the centrifugal bowl drive device 14.
  • constituent material of the tube examples include various thermoplastic elastomers such as polyvinyl chloride, polyethylene, polypropylene, polyester such as PET and PBT, ethylene-vinyl acetate copolymer (EVA), polyurethane, and polyester elastomer.
  • polyvinyl chloride is particularly preferred.
  • Polyvinyl chloride provides sufficient flexibility and flexibility, is easy to handle, and is suitable for clogging with a clamp or the like.
  • a polymer obtained by polymerizing or copolymerizing olefin or diolefin such as soft polyvinyl chloride, polyolefin, ethylene, propylene, butadiene, and isoprene in which DEHP is used as a plasticizer
  • olefin or diolefin such as soft polyvinyl chloride, polyolefin, ethylene, propylene, butadiene, and isoprene in which DEHP is used as a plasticizer
  • EVA ethylene-vinyl acetate copolymer
  • PET, PBT, PCGT, etc. can be used.
  • polyvinyl chloride is particularly suitable, but a container for storing platelets preferably has excellent gas permeability in order to improve the storage stability of platelets, and polyolefin, DnDP plasticized polyvinyl chloride, etc. are used. It is preferable to use a sheet having a reduced thickness.
  • FIG. 3 shows the structure of the centrifuge bowl E1.
  • the right side of the center line is a cross-sectional view, and the left side is a dotted line showing an external view.
  • an inflow port E1a and an outflow port E1b are formed in the fixed portion 20, which is a fixed portion that does not rotate.
  • a cover 17 and an inflow pipe 18 extending downward are connected to the fixed portion 20.
  • the side wall 21, the outer shell 22, the inner shell 23, and the bottom plate 16 are rotatably held integrally with these fixed portions.
  • the bottom plate 16 is adsorbed by the centrifugal bowl driving device 14 and is given a rotational force by the centrifugal bowl driving device 14.
  • FIG. 3 shows a state in which whole blood is supplied from the inflow port E1a into the centrifuge bowl E1 and blood components are separated by centrifugal force.
  • the red blood cell layer RBC, the white blood cell layer WBC, the buffy coat layer BC, the platelet layer PLT, and the plasma layer PPP are formed by the centrifugal force in descending order of specific gravity.
  • the white blood cell layer WBC and the platelet layer PLT are close in specific gravity, they are difficult to separate. Therefore, there exists a buffy coat layer BC including a white blood cell layer WBC and a platelet layer PLT.
  • the breakdown of whole blood is about 55% for plasma PPP, about 43.2% for red blood cell RBC, about 1.35% for white blood cell WBC, and about 0.45% for platelet PLT.
  • the outflow passage 19 formed slightly above the midpoint of the inflow pipe 18 is formed in the inner peripheral portion, it is formed in the inner periphery in the space formed by the outer shell 22 and the side wall 21. It flows out of the centrifuge bowl E1 through the outlet E1b from the plasma layer PPP.
  • FIGS. 4 and 5 are flowcharts, and FIGS. 6 to 18 illustrate the operation and process of the blood component separation device.
  • the purpose of this device is to collect high-concentration platelet fluid.
  • FIG. 19 shows the operation / action of the blood component separation device in a time series as a process diagram.
  • FIG. 6 is a diagram showing a blood collection start process (first process).
  • a white display indicates an operating state
  • a black display indicates a stopped state.
  • a white display indicates an open state
  • a black display indicates a closed state.
  • the priming step (S1) in FIG. 4 is performed.
  • the ACD pump P4 and the first pump P1 are driven, and ACD liquid for preventing blood coagulation is supplied to the centrifugal bowl E1 through the opened first on-off valve V1, and the centrifugal bowl E1 and the first A priming step (S1) for the pump P1 and the like is performed.
  • the priming is a process in which an ACD solution is previously attached to a portion that comes into contact with blood such as in the donor tube T1, the first pump P1, and the centrifuge bowl E1 so that the blood does not coagulate when flowing. From the priming process, the centrifuge bowl drive device 14 rotates the centrifuge bowl E1 at a predetermined rotation speed.
  • the blood collection needle 2 is punctured into the blood donor and the collection of whole blood is started (S2).
  • the blood donor 2 is punctured into the blood donor, and then the primary blood is collected in the primary blood collection bag Y7 (see FIG. 1) in the primary blood collection circuit.
  • the branch portion provided on the donor tube T1 is initially configured to connect the blood collection needle 2 and the initial blood collection line 4 (see FIG. 1).
  • the initial blood collection line 4 is closed by the clamp 8 (see FIG. 1), and a flow path on the first blood pump P1 side of the donor tube T1 is secured.
  • the ACD pump P4 is driven, the ACD liquid is supplied to the donor tube T1, mixed with the whole blood, and the whole blood is supplied to the centrifuge bowl E1.
  • whole blood is supplied to the rotating centrifuge bowl E1, it is pushed by the plasma from the outflow passage 19 (see FIG. 3) located in the inner peripheral portion of the centrifuge bowl E1, and as shown in FIG.
  • the air in the bowl E1 (shown by a dotted line) flows out.
  • the air that has flowed out is stored in the airbag Y4 through the opened ninth on-off valve V9.
  • the whole blood is separated into each component by applying a centrifugal force to the supplied whole blood in the bowl.
  • the third on-off valve V3 is opened to drive the second blood pump P2.
  • the fourth open / close valve V4 is opened to collect the whole blood from the donor, and the plasma stored in the plasma bag Y1 is mixed with the whole blood and supplied to the centrifugal bowl E1.
  • the current cycle is the final cycle. If the current cycle is not the final cycle (S7: NO), the sixth open / close valve V6 is opened, the state where the first blood pump P1 is driven is maintained, and the temporary storage bag The collected whole blood is stored in Y2 (S11). In other words, the collection of whole blood is continued by storing the whole blood collected in the temporary storage bag Y2. The whole blood is continuously collected until the circulation / acceleration process is completed or until a predetermined amount of time is reached. In the case of the final cycle (S7: YES), the first blood pump P1 is stopped and blood collection is stopped (S8).
  • the circulation rate is made faster than the critical flow step, and plasma is passed through the centrifuge bowl E1 at a rate of about 100 ml / min for about 30 to 40 seconds. Circulate.
  • the particulate matter concentration in the buffy coat layer BC in FIG. 3 is reduced, and the white blood cell layer WBC having a higher specific gravity than the platelets is deposited outside the buffy coat layer BC. That is, the platelet layer PLT and the leukocyte layer WBC can be more clearly separated.
  • the acceleration process in the circulation / acceleration process shown in FIG.
  • the rotation speed of the second blood pump P2 by controlling the rotation speed of the second blood pump P2, the rotation speed is gradually increased and the plasma flow rate is sequentially increased.
  • the flow rate is increased starting from 100 ml / min, and the plasma flow rate is accelerated until platelets flow out.
  • the circulation process and the acceleration process are combined and expressed as a circulation / acceleration process (S9, S12).
  • the platelet PLT gains a force in the ascending direction and is released from the outflow passage 19 to the outside of the centrifugal bowl E1.
  • the white blood cell layer WBC and the red blood cell layer RBC having large specific gravity do not leave the outflow passage 19 because the centrifugal force is stronger.
  • FIG. 20 shows changes in the concentration of platelets, white blood cells, and red blood cells flowing out.
  • the horizontal axis is the time course at the time of platelet collection, and the vertical axis is the concentration of the blood cell component that flows out.
  • TA platelet outflow
  • the amount of platelet outflow increases gradually, and gradually decreases when the maximum flow rate is exceeded.
  • leukocytes gradually increase in outflow and decrease gradually after the maximum flow rate.
  • FIG. 5 Details of S9 and S12 are shown in FIG. 5 as a flowchart showing the operation of the blood component separation device.
  • the platelet outflow period TA includes a low concentration period TB in which low-concentration platelet liquid flows out first, followed by a high concentration period TC in which high-concentration platelet liquid outflows, and then the low-concentration platelet liquid again. It can be divided into low concentration periods TD that flow out. Here, in order to obtain a high concentration platelet solution, a low concentration platelet solution is unnecessary.
  • the second on-off valve V2 is closed.
  • the fifth on-off valve V5 is opened, and the platelet solution of the low concentration period TB of FIG. 20 is stored in the temporary storage bag Y2 (S22).
  • the low-concentration platelet liquid is stored in the temporary storage bag Y2 in a state of being mixed with the whole blood.
  • the first blood pump P1 is kept in a driving state, and the whole blood collected from the blood donor continues to be stored in the temporary storage bag Y2.
  • the temporary storage bag Y2 is used as a buffy coat bag simultaneously with the whole blood bag.
  • the turbidity sensor C2 detects that the platelet liquid has a high concentration, it is determined that it is a TC period (S23: YES), and the fifth on-off valve V5 is closed as shown in FIG. Then, the eighth on-off valve V8 is opened. Thereby, the high-concentration platelet liquid that flows out during the high-concentration period TC can be stored in the platelet intermediate bag Y3 (S24).
  • the platelet intermediate bag Y3 when a predetermined amount of high-concentration platelet liquid is stored in the platelet intermediate bag Y3, it is determined that it is a TD period (S25: YES), and as shown in FIG. 12, the platelet intermediate bag Y3 Therefore, the eighth on-off valve V8 is closed and the fifth on-off valve V5 is opened. Thereby, the low-concentration platelet liquid flowing out during the low-concentration period TD can be stored again in the temporary storage bag Y2 (S26).
  • the amount of the high-concentration platelet liquid stored in the platelet intermediate bag Y3 can be easily adjusted by controlling the valve opening time of the eighth on-off valve V8 based on the flow rate of the platelet liquid flowing out from the centrifugal bowl E1. Can do. Details of the amount of high-concentration platelet fluid collected in each cycle will be described later.
  • the rotation of the centrifugal bowl E1 is stopped, the sixth on-off valve V6 and the fifth on-off valve V5 are closed, the first on-off valve V1 and the ninth on-off valve V9 are opened, and the first blood pump P1 is reversely rotated.
  • the blood return to return the blood remaining in the centrifuge bowl E1 to the donor is started.
  • the reverse rotation speed of the first blood pump P1 is driven at a double speed of the normal rotation speed to shorten the blood return time.
  • the second blood pump P2 is driven to return the plasma that has been collected too much and stored in the plasma bag Y1.
  • the blood stored in the temporary storage bag Y2 also opens the seventh on-off valve V7, drives the second blood pump P2, and simultaneously flows into the centrifuge bowl E1 through the fourth on-off valve V4 (S14). ).
  • the third on-off valve V3 is closed so that the fluid does not flow into the plasma bag Y1.
  • the ninth on-off valve V9 is closed and the second on-off valve V2 is opened.
  • the plasma overflowing from the centrifugal bowl E1 is stored in the plasma bag Y1.
  • FIG. (Same state), the state in which the second blood pump P2 is driven is maintained, the seventh on-off valve V7 is closed, and the plasma stored in the plasma bag Y1 is mixed with the whole blood and supplied to the centrifuge bowl E1.
  • the third on-off valve V3 is opened, and the plasma critical flow process is started.
  • FIG. 9 (circulation process) is continued.
  • This cycle is usually performed for 3 or 4 cycles until a predetermined amount of platelet PLT is secured.
  • blood is collected in parallel during the circulation period TF2 and acceleration period TG2 of the second cycle, and whole blood is stored in the temporary storage bag Y2.
  • the blood in the temporary storage bag Y2 is mixed with whole blood and supplied to the centrifuge bowl E1.
  • blood is not collected during the circulation period TF3 and the acceleration period TG3. This is because there is no fourth cycle.
  • the amount of platelet liquid collected is determined based on the value of the sensor, and thus varies depending on the blood count value of the blood donor. Therefore, the amount of platelet fluid collected per cycle cannot be controlled to a fixed amount, and the amount of platelet fluid finally collected after a plurality of cycles varies.
  • the platelet preservation solution is injected into the platelet intermediate bag Y3 or the platelet bag Y5 after a plurality of cycles as will be described later.
  • the concentration of platelet fluid the amount of platelet storage solution to be injected fluctuates, making it difficult to adjust the concentration of platelet fluid to a constant level.
  • the second blood pump P2 is controlled by the fluid per unit time.
  • a constant-rate pump with a constant discharge volume is used to drive the second blood pump P2 to collect platelets from the centrifuge (from the start time Ts to the end time Te shown in FIG. 21). Time) is controlled, and a predetermined amount (for example, 25 ml) of platelet fluid is collected in each cycle.
  • the Te at the end of the collection of the platelet liquid into the platelet intermediate bag Y3 by driving the second blood pump P2 can be changed, so that the necessary amount of collected platelet liquid can be obtained. Accordingly, by controlling the timing of Te at the end of the collection of platelet fluid, a certain amount of platelet fluid can be collected in each cycle.
  • 100 ml of platelet preservation solution is injected into the platelet intermediate bag Y3 or the platelet bag Y5, and 100 ml of platelet solution is to be secured in the platelet intermediate bag Y3 in order to bring the concentration of the platelet solution to 50%.
  • 100 ml of platelet fluid is secured in 2 cycles
  • 50 ml of platelet fluid is collected in each cycle
  • 100 ml of platelet fluid is secured in 3 cycles
  • 33 ml or 34 ml of platelet fluid is collected in each cycle.
  • 100 ml of platelet liquid is secured in 4 cycles, it can be controlled to collect 25 ml of platelet liquid in each cycle. In this way, a certain amount of platelet fluid can be collected in each cycle.
  • FIG. 22 shows map data for determining the timing of collecting high-concentration platelet liquid in the first cycle when collecting 10 units of platelets (2.0 ⁇ 10e 11 pieces) in 4 cycles.
  • FIG. 23 is a diagram showing the timing for collecting high-concentration platelet liquid and the concentration of platelet liquid in the first cycle.
  • FIG. 24 is a diagram showing the timing of collecting high-concentration platelet liquid and the concentration of platelet liquid in the second cycle.
  • FIG. 25 is a diagram showing map data for determining the timing of collecting high-concentration platelet liquid in the first cycle when collection is completed in three cycles.
  • the case where 100 ml (each cycle 25 ml) of platelet PLT is secured in 4 cycles will be described.
  • the PLT value and hematocrit value of the blood donor obtained from the primary blood collected in the primary blood collection bag Y7 are input to the blood component separation device.
  • the platelet concentration at which the collection of high-concentration platelet fluid in the first cycle is determined from the input PLT value and HCT value. Is done.
  • the collection start timing of the high-concentration platelet liquid in the first cycle of the blood donor is set when the platelet concentration detected by the turbidity sensor C2 becomes 134 to 125 ⁇ 10e 4 / ⁇ L.
  • the collection start timing of the high-concentration platelet liquid is determined using the PLT value and the HCT value, but the high-concentration platelet liquid is used only using either the PLT value or the HCT value. It is also possible to determine the sampling start timing.
  • a blood count value stored in advance as a blood count value for determining the timing of starting collection of high-concentration platelet fluid, a value (such as a PLT value) obtained from a donor's previous blood donation or the initial value A value obtained from blood flow (such as a PLT value) may be used.
  • each of the high-concentration platelet liquid flowing out of the centrifuge bowl E1 at the start time Ts1 and the end time Te1 is obtained.
  • the platelet liquid concentrations Cs1 and Ce1 at the timing are substantially equal. That is, when the second blood pump P2 is driven as described above to control the time for collecting platelets from the centrifuge and collecting 25 ml in the first cycle, comparing FIG. 23 and FIG. As can be seen, the period during which the platelet concentration is high can be accurately selected. Thereby, since the collection timing of a high concentration platelet liquid can be optimized, more platelets can be collected.
  • the start timing of collection of high-concentration platelet fluid is corrected when the platelet concentration at the start of platelet fluid collection in the immediately preceding cycle reaches the average value at the end of collection.
  • the timing at which the second cycle collection start is corrected so as to eliminate the deviation. it can.
  • the start timing of collecting high-concentration platelet liquid is corrected in each cycle in the same manner as in the second cycle described above, and high-concentration platelet liquid is collected in each cycle. Is called.
  • the collection timing of the high-concentration platelet liquid can be further optimized, so that more platelets can be collected.
  • the third blood pump P3 is driven, and an appropriate amount of platelet storage liquid is injected into the platelet intermediate bag Y3 by the bottle needle 10 connected to the platelet storage liquid bottle. To do. Thereafter, as shown in FIG. 17, the seventh on-off valve 30 is opened, and high-concentration platelet liquid and platelet storage liquid stored in a predetermined amount (for example, 100 ml in the present embodiment) in the platelet intermediate bag Y3. Then, it is injected into the platelet bag Y5 through the leukocyte removal filter X. At this time, the air present in the platelet bag Y5 moves to the airbag Y6.
  • a predetermined amount for example, 100 ml in the present embodiment
  • the third blood pump P3 is driven and connected to the platelet storage liquid bottle.
  • the platelet preservation solution remaining in the platelet preservation solution bottle is injected into the platelet bag Y5 through the sterilization filter 9 and the leukocyte removal filter 11.
  • the high-concentration platelet liquid that has been filtered and remains in the leukocyte removal filter 11 is collected.
  • the two tubes of the platelet bag are sealed. Thereby, the platelet bag Y5 in which the high-concentration platelet liquid is stored is completed.
  • the same method as that for securing the platelet PLT in the above four cycles is performed. That is, the PLT value and the HCT value of the blood donor obtained from the primary blood collected in the primary blood collection bag Y7 are input to the blood component separation device. Then, referring to the map data shown in FIG. 25 stored in advance in the blood component separation device, the platelet concentration at which the collection of high-concentration platelet fluid in the first cycle is determined from the input PLT value and HCT value. Is done.
  • the timing of starting collection of high-concentration platelet fluid in the first cycle of the donor is determined by the turbidity sensor C2. This is set when the platelet concentration detected in (1) reaches 84 to 75 ⁇ 10e 4 / ⁇ L.
  • the second blood pump P2 which is a metering pump, is driven to extract platelets from the centrifuge bowl E1 so as to collect a predetermined amount of platelet liquid.
  • the amount of platelet fluid collected per cycle can be controlled to a constant amount. Therefore, after a plurality of cycles, a certain amount of platelet liquid can be finally secured, and thereafter, the concentration of the platelet liquid can be easily adjusted.
  • the platelet concentration at each timing of flowing out from the centrifuge bowl E1 is stored in advance at the start timing and the end timing of collection of the high-concentration platelet liquid.
  • the start timing of collecting high-concentration platelet fluid is determined from the blood count of the supplier.
  • FIG. 27 shows the system configuration of the blood component separation apparatus of the second embodiment.
  • the blood component separation circuit 30 according to the second embodiment does not have the temporary storage bag Y2 as a main point different from the first embodiment.
  • FIG. 28 is a flowchart showing the operation of the blood component separation device
  • FIGS. 29 to 31 show the operation and process of the blood component separation device.
  • the blood component separation device of Example 2 performs the priming process as in Example 1 (S101). At this time, as shown in FIG. 29, collection of whole blood is started, and centrifugation is started (S102, first blood collection step). Thereafter, the ninth on-off valve V9 is closed, the second on-off valve V2 is opened, and the plasma overflowing from the centrifugal bowl E1 is stored in the plasma bag Y1.
  • the first on-off valve V1 is closed as shown in FIG. V3 is opened and the plasma is returned to the centrifuge bowl E1 (S104, first circulation step).
  • the first on-off valve V1 is opened, the collection of whole blood is resumed, and the blood is introduced into the centrifuge bowl E1 (S105, second blood collection step).
  • the first opening / closing operation is performed as in the first circulation step.
  • the valve V1 is closed, the collection of whole blood is temporarily stopped, the third on-off valve V3 is opened, and the plasma is returned to the centrifuge bowl E1 (S107, second circulation step).
  • the circulation rate is increased from 60 ml / min to 170-200 ml / min.
  • the first on-off valve V1 is opened to resume the collection of whole blood, and in order to ensure the collection of platelets, the blood collection amount automatically calculated according to the hematocrit value (Hct value) is collected. (S108, third blood collection step).
  • the first on-off valve V1 is closed to suspend the collection of whole blood and perform circulation to return the plasma to the centrifugal bowl E1, but gradually accelerate the circulation speed (S109, acceleration step).
  • the circulation rate is increased from 60 ml / min to 150 ml / min, and finally increased to 200 ml / min.
  • the platelet liquid stored in the platelet intermediate bag Y3 is injected into the platelet bag Y5 via the leukocyte removal filter 11, and then the platelets Seal the two tubes of the bag. Thereby, the platelet bag Y5 in which the high-concentration platelet liquid is stored is completed. Thereby, all the processes are completed. If it is not the last cycle (S112: NO), the process returns to the first blood collection step (S102) again.
  • the second blood pump P2 which is a metering pump, is driven to collect platelets so as to collect a predetermined amount of platelet liquid.
  • the amount of platelet fluid collected per cycle can be controlled to a constant amount. Therefore, after a plurality of cycles, a certain amount of platelet liquid can be finally secured, and thereafter, the concentration of the platelet liquid can be easily adjusted.
  • the buffy coat bag and the whole blood bag are used as the temporary storage bag Y2, but the buffy coat bag and the whole blood bag may be provided in parallel as separate bags.

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PCT/JP2012/073197 2012-03-27 2012-09-11 血液成分分離装置 WO2013145374A1 (ja)

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JPH07313588A (ja) * 1994-05-23 1995-12-05 Terumo Corp 血液成分分離装置および血液成分分離方法
JPH08509403A (ja) * 1993-04-27 1996-10-08 ヘモネティクス・コーポレイション アフェレーシス装置及び方法
JP2004358041A (ja) * 2003-06-06 2004-12-24 Terumo Corp 血液成分採取装置
WO2007119401A1 (ja) * 2006-03-17 2007-10-25 Terumo Kabushiki Kaisha 血液成分採取装置
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IT1302015B1 (it) * 1998-08-07 2000-07-20 Dideco Spa Sistema di controllo automatico di cella per la centrifugazione delsangue.
JP3936142B2 (ja) * 2000-02-04 2007-06-27 テルモ株式会社 血液成分採取装置
JP4299452B2 (ja) * 2000-11-28 2009-07-22 テルモ株式会社 血小板採取装置
JP4832683B2 (ja) * 2001-09-19 2011-12-07 テルモ株式会社 血小板採取装置
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JPH07313588A (ja) * 1994-05-23 1995-12-05 Terumo Corp 血液成分分離装置および血液成分分離方法
JP2004358041A (ja) * 2003-06-06 2004-12-24 Terumo Corp 血液成分採取装置
WO2007119401A1 (ja) * 2006-03-17 2007-10-25 Terumo Kabushiki Kaisha 血液成分採取装置
JP2009226210A (ja) * 2008-02-29 2009-10-08 Haemonetics Corp アフェレーシス装置

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CN104203302A (zh) 2014-12-10
CN104203302B (zh) 2016-06-22
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JP6081448B2 (ja) 2017-02-15
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