WO2008056733A1 - Appareil de collecte de composant sanguin - Google Patents

Appareil de collecte de composant sanguin Download PDF

Info

Publication number
WO2008056733A1
WO2008056733A1 PCT/JP2007/071698 JP2007071698W WO2008056733A1 WO 2008056733 A1 WO2008056733 A1 WO 2008056733A1 JP 2007071698 W JP2007071698 W JP 2007071698W WO 2008056733 A1 WO2008056733 A1 WO 2008056733A1
Authority
WO
WIPO (PCT)
Prior art keywords
blood
pressure
donor
return
pump
Prior art date
Application number
PCT/JP2007/071698
Other languages
English (en)
Japanese (ja)
Inventor
Yoshiki Takagi
Yoshiteru Hoshino
Shinya Sano
Original Assignee
Terumo Kabushiki Kaisha
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 Terumo Kabushiki Kaisha filed Critical Terumo Kabushiki Kaisha
Priority to JP2008543116A priority Critical patent/JP4979709B2/ja
Publication of WO2008056733A1 publication Critical patent/WO2008056733A1/fr

Links

Classifications

    • 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
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3639—Blood pressure control, pressure transducers specially adapted therefor
    • 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

Definitions

  • the present invention relates to a blood component collection apparatus that collects blood from a donor, separates the collected blood into a plurality of components, collects predetermined components, and returns the remaining components to the donor.
  • Blood collection includes whole blood collection in which blood is collected as it is and component blood collection in which only predetermined components are extracted.
  • component blood collection the blood collected from the donor is centrifuged to extract certain components, and other components are returned to the donor.
  • the necessary components plasma and platelets
  • a blood component collection apparatus for automatically collecting such component blood has been put into practical use.
  • the blood component collection device After a needle is punctured into a donor, blood collection processing is performed through the needle, the collected blood is separated into a plurality of components, and a predetermined component is collected; and The process of returning the remaining components from the needle to the donor is automatically performed by rotating the pump under the action of a predetermined control unit.
  • a tube is attached to the pump.
  • the pump When collecting blood, the pump is rotated forward to suck and draw blood from the tube, and when returning blood, the pump is rotated backward to send the remaining components to the tube.
  • the flow rate of blood and blood components in the tube during blood collection and return can be changed according to the rotational speed of the pump.
  • the blood component may stay in a compressed state when returning blood, The pressure of the part rises and acts to push back the needle. As a result, the needle tip is withdrawn from the vein, blood is pumped out of the blood vessel, and internal bleeding occurs. Even if the needle tip does not lose its venous force, the same condition occurs when blood leaks from the gap between the needle and the blood vessel wall.
  • the donor may feel a little uncomfortable or the donor or operator may be aware that the puncture site is swollen. Also, you may not notice. When such internal bleeding occurs, the skin may be swollen or discolored externally, and it may take some time to recover, and may make the donor feel uncomfortable or anxious.
  • a blood component collection device is a blood component collection device that returns a predetermined blood component to a donor after separating the blood collected from the donor, and returns the remaining blood component to the donor.
  • one of the conditions is that when the blood pump is rotated and blood return is started, the pressure corresponds to the cumulative rotational speed of the blood pump, the cumulative liquid supply amount, or the blood return elapsed time. If the limit threshold for setting is exceeded, the condition may be met.
  • the pressure is the cumulative rotational speed of the blood pump, the cumulative liquid supply amount, or the blood return progress.
  • the blood pump may be decelerated or stopped when a stop threshold value greater than the limit threshold value set in response to time is exceeded, or when the pressure slope exceeds a predetermined slope.
  • one of the conditions may be a condition indicating a change in a mountain shape that decreases after the pressure increases.
  • the control unit includes a speed detection unit that detects a blood return speed of the blood return line, and one of the conditions is that the blood return speed is a predetermined flow rate threshold value or less. Good.
  • the control unit reduces the pressure of the blood return line or the limit value of the blood return speed according to the condition, and then according to the cumulative rotation speed, the cumulative liquid supply amount, or the elapsed time of the blood pump.
  • the pressure falls below a predetermined recovery judgment pressure threshold, or when the blood return speed exceeds a predetermined recovery judgment flow rate threshold, the pressure of the blood return line or the limit value of the blood return speed is increased. You may let them. According to such conditions, even if the pressure or speed is limited before that, it can be confirmed from the subsequent situation that internal bleeding does not occur. The degree limit is relaxed or restored, and blood can be returned quickly.
  • the blood component collection device is a blood component collection device that returns a predetermined blood component to the donor after separating the blood collected from the donor, and returns the remaining blood component to the donor.
  • the pressure obtained from the pressure sensor is set corresponding to the cumulative rotation speed of the blood pump, the cumulative liquid supply amount, or the blood return elapsed time.
  • a pressure determination process for decelerating or stopping the blood pump is performed when a limit threshold or a stop threshold is exceeded, or when the slope of the pressure exceeds a predetermined slope.
  • the control unit may start the pressure determination process after a predetermined time has elapsed from the start of blood return or after the blood pump has rotated by a predetermined number.
  • the control unit uses the pressure at the start of blood return as an initial pressure, and from the pressure sensor until a predetermined time elapses from the start of blood return or until the blood pump rotates a predetermined number of times.
  • the differential pressure between the obtained pressure and the initial pressure exceeds a predetermined threshold, the differential pressure determination process for decelerating or stopping the blood pump may be performed.
  • FIG. 1 is a perspective view showing a blood component collection device according to the present embodiment.
  • FIG. 2 is a block configuration diagram of a control unit.
  • FIG. 3 is a circuit diagram of a blood collection kit.
  • FIG. 4 is a flowchart showing a procedure for collecting blood components performed by the blood component collecting apparatus.
  • FIG. 5 is a flowchart of the first embodiment of the blood return process.
  • FIG. 6 is a flowchart of corresponding processing.
  • FIG. 7 is a graph showing changes in donor pressure and blood return speed in the blood return process.
  • FIG. 8A is a diagram showing the contents of the memory in which the initial pressure is recorded at the first time of the pressure value inclination determination process
  • FIG. 8B is a graph when the accumulated rotation speed is 0.25 in the pressure value inclination determination process.
  • 8C is a diagram showing the contents of the memory when the cumulative rotation speed is 0.5 in the pressure value inclination determination process
  • FIG. 8D is the cumulative value in the pressure value inclination determination process.
  • FIG. 8E is a diagram illustrating the contents of the memory when the rotational speed is 2.25
  • FIG. 8E is a diagram illustrating the contents of the memory when the cumulative rotational speed is 2.5 in the pressure value inclination determination processing.
  • FIG. 9A is a diagram showing the contents of the memory at the first time of the differential pressure threshold judgment process
  • FIG. 9B shows the contents of the memory when the cumulative rotation number is 3.0 in the differential pressure threshold judgment process. It is a figure.
  • FIG. 10 is a flowchart of the second embodiment of the blood return process.
  • FIG. 11 is a flowchart (No. 1) of a third embodiment of the blood return process.
  • FIG. 12 is a flowchart (No. 2) of the third embodiment of the blood return process.
  • FIG. 13 is a flowchart (No. 3) of the third embodiment of the blood return process.
  • FIG. 14 is a graph showing changes in initial donor pressure and blood return speed in the third example of the blood return process.
  • FIG. 15 is a graph showing changes in donor pressure and blood return rate over the entire period of the third example of the blood return process.
  • FIG. 16 is a graph showing differential values and second-order differential values of donor pressure.
  • FIG. 1 illustrates an embodiment of the blood component collection device according to the present invention.
  • a blood component collection device 10 includes a device body 12 and a blood collection kit 14 attached to the device body 12.
  • the apparatus main body 12 is provided on the left side of the upper end of the first support column 16a, the box-shaped mechanism main unit 15, the first support column 16a and the second support column 16b extending upward from the left and right sides of the mechanism control unit 15. Whether there is a weigh scale 18, a monitor 20 provided at the upper end of the second support column, and a multi-chamber bag 126 provided on the right side of the first support column 16a.
  • a bag detection sensor 21 for detection a sensor 23a for detecting the presence / absence of a sterilization filter 114 provided on the right side of the second support 16b, a sensor 23b for detecting the presence / absence of a bubble removal chamber 112 and dripping of an anticoagulant
  • the monitor 20 is an input / output device of the blood component collection device 10, and has a large color touch panel 20a and a speaker 20b, and can be easily operated using images and sounds.
  • the speaker 20b is a stereo type.
  • the mechanism main body 15 includes a control mechanism 22 on the left side and a centrifugal separation mechanism (separation means) 24 on the right side.
  • the control mechanism unit 22 includes a control unit 26 that comprehensively controls the entire blood component collection device 10, a blood pump 28, an anticoagulant pump 30, a turbidity sensor 32, six bubble sensors 34a, 34b, 34c, 34d, 34e, 34f, seven clamps 36a, 36b, 36c, 36d, 36e, 36f, 36g, a donor pressure sensor 38, and a system pressure sensor 40.
  • the turbidity sensor 32 and the bubble sensors 34a to 34f for example, an ultrasonic sensor, an optical sensor, an infrared sensor, or the like can be used.
  • the turbidity sensor 32 and the bubble sensor 34d are integrally configured.
  • the centrifuge mechanism 24 is a mechanism that is equipped with the centrifuge bowl (centrifuge) 120 of the blood collection kit 14 and centrifuges the blood introduced into the centrifuge bowl 120.
  • the set rotational speed of the centrifuge bowl 120 is set to about 4200 to 5800 rpm, for example.
  • the blood in the blood storage space is separated from the inner layer into a plasma layer (PPP layer), a buffy coat layer (BC layer), and a red blood cell layer (CRC layer).
  • PPP layer plasma layer
  • BC layer buffy coat layer
  • CRC layer red blood cell layer
  • an optical sensor that detects the position of the interface from the transmittance that changes in accordance with the position of the interface between the plasma layer and the buffy coat layer (hereinafter simply referred to as the interface). )
  • the control unit 26 is provided inside the mechanism main body unit 15. Devices other than the control unit 26 in the control mechanism unit 22 are provided on the upper surface, the front surface, and the support column so that the tube of the blood collection kit 14 can be attached.
  • the blood pump 28 and the anticoagulant pump 30 are a roller pump type that pushes the blood inside by continuously rolling the roller against the side of the tube, and in a non-contact state with respect to the blood. It can be driven.
  • the blood pump 28 and the anticoagulant pump 30 are variable in speed and fluid discharge direction under the action of the control unit 26.
  • the blood pump 28 is a suction pump that draws blood by rotating in a predetermined positive direction during blood collection. When the blood is returned, it rotates in the opposite direction and functions as a discharge pump that sends blood components to the tube 104.
  • the turbidity sensor 32 is a sensor that detects the turbidity of the liquid that passes through the sandwiched tube.
  • the bubble sensors 34a to 34f are sensors that detect the presence or absence of liquid passing through the sandwiched tube or bubbles.
  • the clamps 36a to 36g press and close the sandwiched tube from both sides, or open and communicate with each other, thereby acting as an open / close valve. These clamps 36a to 36g are concentrated in one section on the upper surface of the control mechanism 22 so that the cassette housing 42 can be fitted.
  • the cassette housing 42 is a resin member for integrally assembling and arranging many parts of the tubes of the blood collection kit 14, and the cassette housing 42 is fitted into the upper surface of the control mechanism 22 so as to obtain a predetermined tube. Are arranged to be openable and closable by the corresponding clamps 36a to 36g.
  • the donor pressure sensor 38 is a sensor for measuring the donor pressure Pd indicating the pressure of the blood collection line by inserting a part of the blood collection path system (blood collection circuit) 14a (see FIG. 3) in the blood collection kit 14. Acts as a blood pressure sensor when collecting blood, and acts as a blood pressure sensor when returning blood.
  • the system pressure sensor 40 is a sensor into which a part of the processing path system 14b (see FIG. 3) is inserted and measures the system pressure (in-circuit pressure) Ps indicating the pressure in the circuit. It should be noted that the arrangement of the tubes in the blood collection kit 14 in the state of being set in the apparatus main body 12 is not the gist of the present invention! /, So FIG. Show me!
  • the control unit 26 includes a blood pump driver 76, an anticoagulant pump driver 78, a motor driver 80, and a clamp driver 82 for output. Controls coagulant pump 30, motor 64 and clamps 36a-36g.
  • the blood pump driver 76 controls the speed and discharge direction of the blood pump 28.
  • Anticoagulant pump driver 78 controls the speed of anticoagulant pump 30.
  • the motor driver 80 controls the rotational speed of the motor 64.
  • the clamp driver 82 individually controls the opening and closing of the clamps 36a to 36g.
  • control unit 26 includes an input interface 84 that performs input control of each sensor, and a monitor interface 86 that performs input and output of the monitor 20. Further, the control unit 26 cooperates with each functional unit to perform a component blood collection processing operation including initial processing, blood collection, separation collection, and blood return processing.
  • a mode control unit 88 for controlling an abnormality an abnormality monitoring unit 90 for monitoring an abnormality based on an input signal of each sensor, a storage unit 92 for storing a predetermined program and data, a timer 94, and an external device
  • a communication unit 96 that performs data communication
  • a speed detection unit 98 that obtains a blood collection speed and a blood return speed V based on the rotation speed of the blood pump 28.
  • the mode control unit 88 includes a suction control unit 88a that performs control in the blood collection process, and a discharge control unit 88b that performs control in the blood return process.
  • the suction control unit 88a and the discharge control unit 8 8b include a function of controlling the rotational speed N of the blood pump 28 based on the donor pressure Pd.
  • control unit 26 Some of the functions in the control unit 26 are not shown in the program recorded in the storage unit 92.
  • the blood collection kit 14 has a blood collection path system 14a for collecting and returning blood from a donor, and a processing path system 14b for centrifuging or circulating the collected blood.
  • the blood collection path system 14a includes a hollow blood collection needle 100 that punctures a donor, and a tube 104 that has one end connected to the blood collection needle 100 and the other end connected to the processing path system 14b via a branch joint 102.
  • a chamber 106 provided in the middle of the tube 104, an anticoagulant container connecting needle 108 connected to an anticoagulant container 107 (see FIG. 1) containing an anticoagulant, and one end of the anticoagulant container 107
  • It has a tube 110 connected to the agent container connecting needle 108, a bubble removal chamber 112 and a sterilization filter (a foreign matter removal filter) 114 provided in the middle of the tube 110.
  • the tube 104 and the tube 110 are connected by a branch joint 116 provided near the blood collection needle 100.
  • the tube 104 (and a tube 140 described later) is commonly used for blood collection and blood return, and functions as a blood collection line and a blood return line.
  • the chamber 106 removes air bubbles and microaggregates in the blood passing through the tube 104.
  • One end of the chamber 106 is provided with a short tube 118 branched from the tube 104.
  • the end of the tube 118 is connected to a breathable and bacteria-impermeable filter (not shown) and inserted into the donor pressure sensor 38, so that the donor pressure Pd can be measured.
  • An anticoagulant container 107 connected to the anticoagulant container connecting needle 108 stores an anticoagulant such as ACD-A liquid.
  • a part of the tube 110 is attached to the anticoagulant pump 30, and the anticoagulant supplied from the anticoagulant container connecting needle 108 under the action of the anticoagulant pump 30 passes the tube 110 and the branch joint 116.
  • a bubble sensor 34a is attached in the middle of the tube 110.
  • a bubble sensor 34b and a clamp 36a are mounted between the chamber 106 and the branch joint 102.
  • the clamp 36a is mounted in the vicinity of the branch joint 102, and the blood collection path system 14a and the processing path system 14b are communicated by opening the clamp 36a.
  • the tube 104 is equipped with two bubble sensors 34e and 34f that are directly IJed and can detect bubbles and air with force S.
  • the treatment path system 14b includes a centrifuge bowl 120, a plasma collection bag 122, a platelet collection bag 124, an intermediate knob 126a, an Ernogug 126b, a knob 128, and a white-removal finalizer. 130.
  • Plasma collection bag 122 and platelet collection bag 124 are bags for storing plasma and platelets obtained by a process such as centrifugation.
  • the plasma collection bag 122 is suspended on a hook 18a of a weighing scale 18 (see FIG. 1), and the weight of the stored plasma can be measured.
  • the blood platelet collection bag 124 is suspended on the front surface of the mechanism main body 15 (see FIG. 1).
  • the intermediate bag 126a is a container for temporarily storing collected platelets (concentrated platelets).
  • the air bag 126b is a container for temporarily storing sterile air in the circuit.
  • the air bag 126b and the intermediate bag 126a are independent containers separated in terms of a circuit, but are physically integrated to form a multi-chamber bag 126.
  • the multi-chamber bag 126 is suspended on the hook 21a of the bag detection sensor 21 (see FIG. 1).
  • the nose 128 is a bag connected to the platelet collection bag 124, and is used when the air in the platelet collection bag 124 is discharged after the component blood collection.
  • a flexible sheet material made of resin (for example, soft polychlorinated bur).
  • the peripheral edge is fused (heat fusion, high-frequency fusion, ultrasonic fusion, etc.) or bonded with an adhesive to form a bag.
  • the sheet material used for the platelet collection bag 124 it is more preferable to use a sheet material having excellent gas permeability in order to improve platelet storage stability.
  • a sheet material for example, polyolefin or DnDP plasticized polychlorinated butyl can be used.
  • the leukocyte removal filter 130 is a filter that separates and removes leukocytes in the blood component when the blood component is transferred from the intermediate bag 126a to the platelet collection bag 124. As can be seen from FIG. 1, the leukocyte removal filter 130 is disposed at a higher position than the platelet collection bag 124, which is lower than the intermediate bag 126a.
  • a tube 140 is connected between the branch joint 102, which is the end of the processing path system 14b, and the inlet of the centrifuge bowl 120.
  • a part of the tube 140 is attached to the blood pump 28. Therefore, by rotating the blood pump 28 in the forward direction, blood can be introduced into the centrifuge bowl 120 from the blood collection path system 14a, or a predetermined circulation operation can be performed in the processing path system 14b. Further, by reversing the blood pump 28, a predetermined blood component can be led out to the blood collection path system 14a and returned to the donor.
  • a tube 142 is connected to the discharge port of the centrifuge bowl 120, and the tube 142 is branched into three forks via a branch joint 144 and connected to the tube 146, the tube 148, and the tube 150.
  • the tube 142 is connected in series with the turbidity sensor 32 and the bubble sensor 34d.
  • the tube 146 is connected to the air bag 126b, and the tube 146 is attached to the clamp 36e along the way!
  • the end of the tube 148 is connected to a breathable and bacteria-impermeable filter (not shown) and inserted into the system pressure sensor 40, so that the system pressure Ps can be measured.
  • the end of the tube 150 is connected to the plasma collection bag 122, and it is branched in the middle.
  • a joint 152 is provided and connected to the intermediate bag 126a via the tube 154.
  • Tube 154 is attached to clamp 36d.
  • a tube 150 between the branch joint 152 and the plasma collection bag 122 is attached to the clamp 36c.
  • the intermediate bag 126a and the platelet collection bag 124 are connected by a tube 156, and a leukocyte removal filter 130 is provided in the middle thereof.
  • a tube 156 between the intermediate bag 126a and the platelet collection bag 124 is attached to the bubble sensor 34c and the clamp 36g.
  • a filter 160 branched from the tube 156 is provided!
  • the filter 160 includes a fungi-impermeable vent filter and a cap.
  • a branch joint 162 is provided on the tube 156 between the bubble sensor 34c and the clamp 36g, and is connected to the plasma collection bag 122 via the tube 164.
  • a branch joint 166 is provided in the middle of the tube 164.
  • the branch joint 166 and the branch joint 102 are connected by a tube 168.
  • the tube 1 64 between the branch joint 162 and the branch joint 166 is attached to the clamp 36f. In the vicinity of the branch joint 102 in the tube 168, a clamp 36b is attached.
  • the platelet collection bag 124 and the bag 128 are connected by a tube 158.
  • the blood collection kit 14 configured as described above is subjected to a predetermined sterilization process in advance.
  • the blood collection kit 14 is provided with a cassette housing 42 in which tubes are arranged in a concentrated manner, and a filter cassette 170 (see FIG. 1) that holds a part of the tubes and a filter 160.
  • predetermined initial processing is performed in step S 1 of FIG.
  • the blood collection needle 100 of the tube 110 and the tube 104 to the chamber 106 is primed with an anticoagulant, and then the blood collection needle 100 is punctured into the donor's blood vessel.
  • the color touch panel 20a of the monitor 20 is operated to start component blood collection processing. Subsequent steps are performed automatically under the action of the control unit 26.
  • step S2 a first plasma collection step is performed.
  • This first plasma collection step involves centrifugation. This is a step of collecting plasma obtained by introducing blood into the blood storage space of the bowl 120 and centrifuging it into the plasma collection bag 122.
  • blood blood added with an anticoagulant
  • the tube 104 blood is transferred through the tube 104 and introduced into the blood storage space of the rotor from the inlet of the centrifugal bowlet 120.
  • the air in the centrifuge bowl 120 is sent into the air bag 126b through the tube 142 and the tube 146.
  • the rotation of the rotor of the centrifuge bowl 120 is started with a predetermined amount of blood being introduced into the blood storage space.
  • the rotational speed of the rotor is kept constant until step S9.
  • the blood introduced into the blood storage space is separated from the inside into three layers: a plasma layer, a buffy coat layer, and a red blood cell layer.
  • the motor 64 is driven simultaneously with the blood pump 28.
  • step S3 the signal of the bubble sensor 34d provided in the tube 142 is monitored, and after detecting that the fluid flowing through the tube; L42 has changed from air to plasma, the clamp 36e is closed and the clamp 36c is opened. .
  • the plasma also flows out from the discharge loca of the centrifuge bowl 120. Therefore, this timing is detected by the bubble sensor 34d, and the clamping operation is performed.
  • Plasma is switched to the plasma collection bag 122 through the tube 150 and collected.
  • the weight of plasma introduced into the plasma collection bag 122 is measured by a weigh scale 18. After confirming that a predetermined amount of plasma has been collected in the plasma collection bag 122 based on the weight signal obtained from the weigh scale 18, the process proceeds to step S4.
  • a constant-speed plasma circulation step is performed.
  • the constant-speed plasma circulation step is a step of circulating the plasma in the plasma collection node 122 at a constant speed in a circulation circuit including a blood storage space. That is, the clamp 36a is closed, the clamp 36b is opened, and the anticoagulant pump 30 is stopped. As a result, the blood collection is temporarily interrupted, and a path for circulating the plasma in the plasma collection bag 122 is formed.
  • This circulation circuit reaches the blood storage space from the plasma collection bag 122 through the tubes 164, 168 and 140, and the plasma that has also flowed out from the centrifuge bowl 120 into the plasma collection bag 122 through the tubes 142 and 150. It is a route to collect.
  • step S5 a second plasma collection step is performed.
  • plasma is collected and centrifuged in the same manner as in the first plasma collecting step.
  • the interface gradually approaches the rotation axis of the centrifuge bowl 120, so that the detection signal from the optical sensor 62 is After confirming that the interface has reached the predetermined level based on the above, go to step S6.
  • step S6 an accelerated plasma circulation step is performed.
  • the accelerated plasma circulation step is a step of circulating the plasma in the plasma collection node 122 in the circulation circuit while accelerating the plasma in the blood storage space. After the plasma circulation rate reaches the predetermined rate, the process proceeds to step S7.
  • step S7 a third plasma collection step is performed.
  • plasma is collected in the same manner as in the first and second plasma collection steps. After confirming that a certain amount of plasma has been collected in the plasma collection bag 122, the process proceeds to step S8.
  • step S8 a platelet collecting step is performed.
  • the plasma in the plasma collection bag 122 is circulated while accelerating in the blood storage space at the first acceleration, and then changed to a second acceleration larger than the first acceleration.
  • platelets are allowed to circulate while being accelerated in order to discharge platelets from the blood storage space, and concentrated platelets are collected (stored) in the intermediate bag 126a.
  • the clamp 36e is opened, the other clamps 36a to 36d, 36f and 36g are closed, and the blood pump 28 is stopped.
  • step S9 the rotational speed of the motor 64 is controlled to decelerate and stop the rotor.
  • step S10 the blood return process is started.
  • the blood return process is a process in which blood components (mainly red blood cells and white blood cells) remaining in the blood storage space of the rotor are returned to the donor. That is, the clamp 36a and the clamp 36e are opened, and the blood pump 28 is reversed. As a result, the blood component remaining in the blood storage space of the rotor is also discharged from the introduction locus of the centrifugal bowl 120 and returned (returned) to the donor via the tube 104 (blood collection needle 100). Details of the blood return process will be described later.
  • the blood return process is terminated based on a predetermined termination condition.
  • step S11 it is confirmed whether or not the predetermined number of cycles has been completed. If it has not been completed, the process returns to step S2 to continue processing such as blood collection and blood return.
  • the filtration process is started in step S5.
  • the concentrated platelets temporarily collected (stored) in the intermediate knob 126a are supplied to the leukocyte removal filter 130, and the concentrated platelets are filtered, that is, the leukocytes in the concentrated platelets are separated and removed. It is a process. Concentrated platelets from which white blood cells have been removed are stored in a platelet collection bag 124.
  • This blood return process includes a differential pressure threshold determination process (differential pressure determination process) performed in a relatively short time after the start, and a pressure value gradient determination process (pressure determination process) performed thereafter.
  • differential pressure threshold determination process differential pressure determination process
  • pressure value gradient determination process pressure determination process
  • graphs 510 and 512 indicated by broken lines are cases in which it is determined that there is a possibility that internal hemorrhage that may cause a sense of incongruity to the donor may occur, and graphs indicated by bold lines 526 This is a case where it is judged that there is a possibility that internal bleeding may occur because the blood collection needle 100 is detached from the donor's blood vessel, etc. And 524 are cases in which there is no possibility of internal bleeding.
  • vertical axes 530, 532, and 534 are springs representatively showing the points at which the blood return speed V of the blood pump 28 reaches 50 mL / min, 60 mL / min, and 90 mL / min. Since the blood collection rate at the time of blood collection is defined as a positive value, the blood return rate V is expressed as a negative value.
  • step S 101 of FIG. 5 measurement of the cumulative rotational speed A of the blood pump 28 and the donor pressure Pd is started.
  • the donor pressure Pd at the start of blood return obtained in step S101 is stored as the initial pressure P0.
  • step S102 the blood return limiting pressure P is set to 10 to 150 mmHg. 1st fruit
  • the blood return limit pressure P is set to lOOmmHg. This return limiting pressure P is
  • the pressure difference between the donor pressure Pd and the initial pressure PO (hereinafter referred to as the donor pressure Pd) is too high.
  • the pressure value becomes a reference pressure for performing a predetermined process such as reducing the rotation speed (the number of rotations per hour) of the blood pump 28 in order to lower the donor pressure Pd.
  • the inclination threshold P is set to 1050 mmHg. In the first embodiment, the inclination threshold P is set to
  • This slope threshold P is a stable blood return condition except immediately after the start of blood return.
  • the inclination threshold P is an allowable fluctuation range during the predetermined rotation of the blood pump 28, and this
  • the predetermined value is preferably set according to the number of rollers of blood pump 28 (roller pump).
  • step S103 the blood pump 28 is rotated to start blood return. Blood pump
  • the blood pump 28 controls the rotation speed so that the blood return speed V becomes a predetermined blood return speed set value.
  • the blood return rate set value is, for example, 20 mL / min in the initial state, and is set to accelerate until reaching the blood return rate set value of 90 mL / min.
  • step S104 whether the cumulative rotational speed A has increased by 0.25 with reference to the start of blood return or the previous time when donor pressure Pd was measured (step S105), that is, blood pump 28 Check if has rotated 0.25. If 0.25 revolutions have been made, the process moves to step S105. If less than 0.25 revolutions, the system waits.
  • step S105 the donor pressure Pd at that time is measured and recorded.
  • the initial pressure P0 and the donor pressure Pd are stored in a so-called ring buffer. The method of using this ring buffer will be described later (see Figures 8A to 9B).
  • step S106 the first differential pressure ⁇ ⁇ ⁇ ⁇ 1 is obtained as ⁇ 1-Pd-PO.
  • the donor pressure Pd used here is the value measured in the immediately preceding step S105.
  • the differential pressure ⁇ PI is the same as the donor pressure Pd, but it is compared with the second differential pressure ⁇ 2 described later.
  • step S107 the first differential pressure ⁇ ⁇ 1 is compared with the blood return restriction pressure P, and ⁇ ⁇ 1 ⁇
  • step S108 If it is Ll L1, go to step S108, if ⁇ ⁇ , go to step S109
  • step S107 is for proactively examining the presence of signs of internal bleeding that may cause the donor to feel uncomfortable.
  • the donor pressure Pd that is, the first differential pressure ⁇ ⁇ 1
  • the donor pressure Pd that is, the first differential pressure ⁇ ⁇ 1
  • the donor may feel uncomfortable in the initial stage (for example, the cumulative rotation speed A is up to 2.5) in the range above the blood return restriction pressure P in FIG. Is the main departure
  • step S108 it is determined that there is a possibility of internal bleeding that may cause a sense of incongruity to the donor, and the corresponding process of step S108 is performed.
  • the graphs 522 524 and 526 are not limited by the blood return limiting pressure P.
  • step S201 the blood pump 28 is stopped (or decelerated) in step S201, and predetermined information is displayed on predetermined acoustic means or the monitor 20 in step S202. To report to. Thereafter, the necessary treatment is performed in step S203, and if it is determined in step S204 that the operator can resume the blood return, the blood return is resumed by pressing a resume button (not shown). To do. If it is determined that it is not possible to return the blood, take necessary measures and then press the stop button (not shown) to interrupt the blood return. [0097] Returning to FIG. 5, in step S109, it is confirmed whether or not the cumulative rotation speed A has reached 2.5 rotations. If it has reached, the process proceeds to step S110, and if it has not, Return to step S10-4.
  • step S110 whether the cumulative rotational speed A has increased by 0.25, based on the previous time when donor pressure Pd was measured (step S105 or S 111), that is, blood pump 28 force 0.25 rotation Ensuring the power, power, and power If 0.25 revolutions have been made, the process proceeds to step S111. If less than 0.25 revolutions, the process waits.
  • step S111 the donor pressure Pd at that time is measured and recorded.
  • This donor pressure Pd is stored in a so-called ring buffer.
  • step S112 the second differential pressure ⁇ ⁇ 2 is obtained as A P2-Pd-Pd.
  • the subscripts N and N-2 indicate the order in which the donor pressure Pd was measured.
  • the subscript N indicates the value measured in the immediately preceding step S105, and the subscript N-2 is twice. Indicates the value measured before. Since this series of processing is performed every time the blood pump 28 rotates 0.25, Pd is the donor when the blood pump 28 is rotated 0.5 times.
  • This second differential pressure ⁇ ⁇ 2 indicates the slope of the donor pressures Pd and Pd
  • step S113 it is checked whether or not the second differential pressure ⁇ 2, which is the slope of the donor pressure Pd, exceeds the slope threshold value P of a predetermined slope (that is, 20 mmHg / 0.5 rev). That is, the second difference
  • step S113 is a proactive test for the presence of signs of internal bleeding that may cause the donor to feel uncomfortable.
  • Fig. 7 if the second differential pressure ⁇ 2 is greater than or equal to the slope threshold P, In other words, branch processing is performed, and return of blood is interrupted by step S114 of the corresponding processing to prevent internal bleeding.
  • step S114 it is determined that there is a possibility of internal bleeding that may give a sense of incongruity, and the corresponding process of step S114 is performed.
  • the graphs 522 and 524 are not limited by the slope threshold P.
  • the graph 526 is improved by performing the processing using the slope threshold value P.
  • step S114 The handling process in step S114 is the same process as in step S108.
  • step S115 the completion of the blood return process is confirmed. That is, when the cumulative rotation speed A reaches a predetermined value and it can be determined that a predetermined amount of blood component has been returned, the blood return process shown in FIG. 5 is terminated, and in other cases, the process returns to step S110. Continue to return blood.
  • the memory 600 is a part of the RAM, and is composed of ten consecutive addresses adO adlO.
  • the memory 600 is used as a so-called ring buffer.
  • the initial pressure P0 obtained in step S101 of the differential pressure threshold determination process is as follows. Is recorded in all of the addresses adO to adlO as shown in FIG. 8A.
  • the first differential pressure ⁇ ⁇ 1 at this time is obtained by subtracting the value of the address adO (P1) and the value of the adjacent address adl (PO) by the force address pointer operation that is ⁇ ⁇ 1—PI—P0.
  • the address pointer operation may be set to be updated by 1 every time data is written to the address indicated by the address pointer, and the address value indicated by the updated address pointer may be read as P0.
  • hatched addresses indicate a portion referred to for obtaining the first differential pressure ⁇ ⁇ 1 or the second differential pressure ⁇ 2.
  • the donor pressure Pd P2 obtained at the second time is recorded at the address adl as shown in FIG. 8C.
  • the first differential pressure ⁇ ⁇ 1 at this time is obtained by subtracting the value of the address adl (P2) and the value of the adjacent address ad2 (P0) by the force address pointer operation that is ⁇ ⁇ 1—P2—P0.
  • the donor pressure Pd is sequentially recorded in ascending addresses, and the first differential pressure ⁇ ⁇ 1 is obtained by subtracting the value of the next address (that is, P0).
  • the donor pressure Pd Pl 1 first obtained in step S111 of the pressure value inclination determination process is recorded at address adlO.
  • the second differential pressure ⁇ ⁇ 2 at this time is obtained by subtracting the value of the address ad8 (P9) next to the address adlO (PI 1) from the value of address adlO (PI 1) by the force address pointer operation of ⁇ ⁇ 2— ⁇ 11—P9 .
  • the address pointer operation is set to be updated by 1 every time data is written to the address indicated by the address pointer I
  • the value of the address indicated by I3 is P11
  • 1 ⁇ 2 The address value indicated by is P9.
  • the address pointer operation is not limited to this.
  • the donor pressure Pd P12 obtained at step S111 for the second time is recorded in the address adO as shown in FIG. 9B.
  • the second differential pressure ⁇ ⁇ 2 at this time is ⁇ ⁇ 2-P12-P10, and is obtained by the address pointer operation described above.
  • the donor pressure Pd is sequentially written in the range of adO to adlO in ascending order in the same manner. After being recorded and recorded in adlO, return to adO and record again.
  • the second differential pressure ⁇ ⁇ 2 is obtained by subtracting the value of the two adjacent addresses.
  • the cumulative rotational speed A (times) in each of the above descriptions may be replaced with, for example, the cumulative liquid feeding amount A '(mL) and the blood return elapsed time T (min).
  • the blood return elapsed time T is the cumulative time during which the blood pump 28 is operating in the blood return process (blood return process).
  • the first differential pressure ⁇ ⁇ 1 is the difference between the donor pressure Pd at the time of the cumulative rotational speed ⁇ and the initial pressure ⁇ 0, and its slope is ⁇ ⁇ 1 / ⁇ .
  • the blood return limiting pressure P to be compared at that time is expressed as P / A as the slope threshold.
  • ⁇ P can be expressed as ⁇ ⁇ 1 / ⁇ / ⁇ .
  • step S 10 a second embodiment of the blood return process performed in step S 10 (see FIG. 4) will be described with reference to FIG.
  • the following processing is performed each time for blood return processing that is performed multiple times.
  • the blood return limit pressure P is initially set, and thereafter, the inclined region P is set.
  • the slope region P is initially set and then the slope is set.
  • the diagonal area P is set.
  • step S30 The second embodiment of the blood return process is performed as the process shown in FIG. Step S30 ;! S315 in FIG. 10 corresponds to step S10 ;! S115 in FIG. 5 in the first implementation column, and steps S302, S306, S307, and S313 are different from the processing in the first implementation column.
  • step S302 the inclined region P and the inclined region P are set.
  • the slope threshold P is
  • the inclination threshold P is set to 20 mmHg.
  • Figure 7 shows the tilt threshold P as 20mmHg / 0.5 rotation.
  • Inclination threshold P varies during 0.5 rotation of blood pump 28 in the period ⁇ 2.5
  • the allowable width is the same parameter as the slope region ⁇ described above.
  • the inclined region ⁇ is, for example,
  • the inclination threshold P is the same as the inclination area P. 20
  • Figure 7 shows the slope threshold P.
  • Step S306 is a process for obtaining the differential pressure ⁇ PI during the period of ⁇ ⁇ 2.5, and the same process as in step S112 is performed.
  • Step S307 is the same processing as step S107 described above, and is a blood return limiting pressure P.
  • Step S313 is the same processing as step S113 described above.
  • it can be set by the allowable movement range. For example, set to 20 to;! OOmmHg.
  • step S 10 a third embodiment of the blood return process performed in step S 10 (see FIG. 4) will be described with reference to FIGS.
  • the following processing is performed each time for blood return processing that is performed multiple times.
  • step S401 of FIG. 11 measurement of the cumulative rotational speed A of the blood pump 28 and the donor pressure Pd is started. Thereafter, the cumulative rotational speed A and the donor pressure Pd are obtained continuously every minute time by a predetermined processing unit.
  • the blood return limit pressure P1 is set to 170 240 mmHg.
  • the blood return limit pressure P1 is set to 200 mmHg.
  • the blood return limiting pressure P1 is a pressure value that serves as a reference for performing a predetermined process such as reducing the rotational speed of the blood pump 28 to lower the donor pressure Pd when the obtained donor pressure Pd exceeds.
  • the blood return limiting pressure P1 is a substantial limiting pressure that limits the upper limit of the donor pressure Pd. Blood return
  • the control procedure by the control unit 26 when the limiting pressure PI is 200 mmHg and when it is set to 150 mmHg will be described later.
  • step S403 the blood pump 28 is rotated to start returning blood.
  • the blood pump 28 is rotated in the opposite direction to the normal direction at the time of blood collection.
  • Blood pump 28 controls the rotation speed so that blood return speed V becomes a predetermined blood return speed set value.
  • the blood return rate set value is, for example, 20 mL / min in the initial state, and is set to accelerate until reaching the blood return rate set value of 90 mL / min.
  • the blood return limit pressure P1 is set to +200 mmHg in the initial state, and when the donor pressure Pd exceeds the blood return limit pressure P1, control is always performed so that the donor pressure Pd is equal to or lower than the blood return limit pressure P1. Is done.
  • the blood return rate V is expressed as a negative value (see Fig. 14).
  • step S404 it is confirmed whether or not the cumulative number of revolutions 2. has reached 2.5. If so, the process proceeds to step S405, and if not, the process waits.
  • step S405 the donor pressure Pd at that time is examined to obtain a differential pressure ⁇ P from the donor pressure Pd at the start of blood return.
  • step S406 the differential pressure ⁇ ⁇ is confirmed. If ⁇ ⁇ lOOmmHg, the process proceeds to step S407, and if A P ⁇ 100 mmHg, the process proceeds to step S411.
  • the determination in step S406 is a proactive test for the presence of signs of internal hemorrhage that can cause the donor to feel uncomfortable.
  • the donor pressure Pd is equal to or higher than the point P11, or the donor pressure
  • branch processing is performed and blood return is interrupted by the following steps S407 to S409 to prevent internal bleeding.
  • the determination process corresponding to step S406 may be performed at the other end point P 12 (a portion of the cumulative rotational speed A force), which is not necessarily performed only at the point P11, or the point P11. It may be performed once or multiple times between ⁇ P12.
  • the threshold line 501 is the following formula (1) Or, it is expressed by equation (2).
  • a ′ is the cumulative amount of liquid delivered by the blood pump 28 (mU).
  • graphs 510 and 512 indicated by broken lines are cases where it is determined that there is a possibility that internal bleeding may occur, which may give the donor a sense of incongruity, and are indicated by bold lines.
  • Graphs 514, 516, and 518 are cases where internal bleeding that does not cause a sense of incongruity to the donor may occur, and graphs 520, 522, and 524 indicated by thin lines indicate the possibility of internal bleeding. This is the case when it is determined that there is no.
  • graphs 514, 516 and 520 exceed the threshold straight line 502 (limitation threshold). 1S Actually, the limit is reduced by reducing the blood return limit pressure P1 to 150 mmHg as described later. Made.
  • the vertical axes 530, 532, and 534 represent lines representatively showing points where the blood return speed V of the blood pump 28 reaches 50 mL / min, 60 mL / min, and 90 mL / min. It is.
  • step S407 pressure determination processing
  • blood pump 28 is stopped, and in step S408, predetermined information is displayed on predetermined acoustic means or monitor 20, and the operator is notified.
  • the operator presses a resume button (not shown), returns to step S401, and blood return cannot be resumed. If it is determined, take necessary measures, and then press the stop button (not shown) to interrupt blood return.
  • step S411 it is confirmed that the cumulative rotation speed A has reached 10 rotations, and the flow proceeds to step S412.
  • step S412 the donor pressure Pd is confirmed.
  • Pd> lOOmmHg the process proceeds to step S413, and when Pd ⁇ 1 OOmmHg, the process proceeds to step S416 (FIG. 14). Point P22).
  • the determination in step S412 is one of the means for proactively examining the presence or absence of signs of internal bleeding that the donor does not feel uncomfortable, and when the donor pressure Pd exceeds the threshold line 502 (limit threshold). Adjust the return pressure limit P1 appropriately to prevent internal bleeding.
  • the determination process corresponding to step S412 may be performed at the other end point P21 (where the cumulative rotational speed A is approximately 2.65) that is not necessarily performed only at the point P22. It may be performed once or multiple times between points P2;!
  • the threshold straight line 502 is expressed by the following equation (3) or (4).
  • a ′ is the cumulative amount of liquid fed by the blood pump 28 (mU).
  • the threshold line 502 is set to a value smaller than the threshold line 501 represented by the above equation (1) or (2). Is done.
  • the threshold lines 501 and 502 are not necessarily fixed and may be changed empirically.
  • the donor pressure Pd exceeding the threshold line 502 is the first case in which the donor does not feel uncomfortable and internal bleeding may occur, as shown in graphs 514, 516, and 518 in Fig. 14.
  • internal bleeding may occur if blood return is continued as it is. This is considered to be a sign that the fluid resistance at the tip of the blood collection needle 100 increases, and that the blood leaks from the gap between the needle and the blood vessel wall, so that it shifts to the internal bleeding state.
  • step S413 the process of differentiating the acquired donor pressure Pd is started.
  • the Processing is performed in a predetermined routine, and a differential result is supplied every minute time.
  • step S414 the transition state of the differential value of the obtained donor pressure Pd is examined, and when it is determined that the change in the mountain shape that decreases after the donor pressure Pd increases, the return of blood is restricted in step S425. After reducing the pressure P1 to 150 mmHg, go to step S426, otherwise go to step S415.
  • step S414 is determined by the fact that the supplied differential value has switched from a positive value to a negative value.
  • the supplied differential value 550 is a positive value force within a predetermined short period of time. It is judged by a sudden change beyond this.
  • the determination may be made by the fact that the second-order differential value 552 of the donor pressure Pd falls below a predetermined threshold value K1.
  • differential value 550 the differential value 550, the second-order differential value 552, and other waveforms may be determined after removing noise components by predetermined filtering.
  • step S414 it is determined in step S414 that the graph 514 shows a chevron at a location where the cumulative rotational speed A is 10 or less, and it is determined that there is a possibility of internal bleeding that may give the donor a sense of incongruity. Then, the process proceeds to the following step S425.
  • the blood return limit pressure PI in step S402 is set to +120 to +17 OmmHg.
  • the blood return restriction pressure P1 is lowered from 200 mmHg to 150 mmHg, and 1 is set to a flag F of 0 in the initial state.
  • step S415 the blood return restriction pressure P1 is lowered to 150 mmHg, so that even if the donor pressure Pd increases thereafter, the blood pressure is restricted to 150 mmHg, and blood is forced into the donor's vein.
  • speed may be limited in addition to pressure. That is, the blood return rate set value that is initially set to 90 mL / min may be reduced to, for example, 60 mL / min. The same applies to steps S422 and S425.
  • step S417 as in step S414 described above, a change in the mountain shape that decreases after the donor pressure Pd increases is determined. If it is determined that the shape is a mountain shape, the process proceeds to step S426; Move on to step S418.
  • step S417 it is determined in step S417 that the graph 520 shows a chevron at a location where the cumulative rotational speed A is greater than 10, and there is a possibility that internal bleeding that may give the donor a sense of discomfort may occur. It will be judged and it will move to the following step S426. However, in the case of the graph 520, as will be described later, it is determined in the subsequent determination that there is no possibility of internal bleeding, and a predetermined return process is performed.
  • step S418 the value of the donor pressure Pd is confirmed. If Pd> 260 mmHg, the process proceeds to step S407, and if Pd ⁇ 260 mmHg, the process proceeds to step S419.
  • step S418 If the condition of step S418 is satisfied, it is determined that the sign of internal bleeding does not disappear after the return-restricting pressure P1 is reduced, and the return is interrupted by the processes of steps S407 to S410. To do.
  • step S419 the current blood return rate setting value is confirmed, and the value is 50 mL / m. If it is less than in, go to Step S424, and if it exceeds 50mL / min, go to Step S420.
  • the value can be set in the range of 5 to 55 mL / min.
  • step S420 the acquisition of the blood return speed is started, and an average value for the past one minute is obtained by a moving average or the like.
  • step S421 the average value of the blood flow rate obtained in the past 1 minute is confirmed, and when the value exceeds 50 mL / min as the flow rate threshold value, the process proceeds to step S423, and 50 mL
  • the determination in step S421 is one of the means for proactively examining the presence of signs of internal hemorrhage that the donor does not feel uncomfortable.
  • step S421 is bypassed by the branch determination in step S419.
  • step S422 the blood return limit pressure P1 is lowered to 150 mmHg, 1 is set in the flag F, and the process proceeds to step S424.
  • step S423 the blood return restriction pressure P1 is returned to 200 mmHg, and flag F is set.
  • the process of returning the blood return restriction pressure P1 may be gradually relaxed by lOmmHg while observing the situation, for example, without returning to 200 mmHg at a time.
  • step S424 the completion of the blood return process is confirmed. That is, if the cumulative rotation speed A reaches a predetermined value and it can be determined that a predetermined amount of blood component has been returned, the blood return process shown in FIGS. 11 to 13 is terminated. Return to S416 and continue to return blood To do.
  • step S426 the cumulative rotational speed A is obtained, and in step S427,
  • step S428 the blood return speed V at that time is compared with the blood return speed setting value, and if blood return speed V ⁇ blood return speed set value, the process proceeds to step S416, and blood return speed ⁇ blood return speed. If it is the set value, the process proceeds to step S429.
  • the judgment in this step S428 is that the blood return restriction pressure P1 has been reduced to 150 mmHg proactively before that, and it has been confirmed that no internal bleeding has occurred from the subsequent situation.
  • the pressure is returned to the limit pressure P1 and the blood return speed V, etc.) for quick blood return.
  • Such a return determination is made in step S428 under the condition that (1) the blood return speed V ⁇ the blood return speed set value when the cumulative rotational speed A reaches 35.
  • the following conditions may also be used.
  • the blood return speed V ⁇ the blood return speed set value, the cumulative rotational speed A is smaller than a predetermined value (20 to 60), for example, A and 35.
  • the relationship between the cumulative rotational speed A or the elapsed time and the donor pressure Pd or the blood return speed V (that is, the donor pressure Pd depends on the cumulative rotational speed A or the elapsed time.
  • Value is less than + 150mmHg, or the blood return speed V exceeds the recovery judgment flow rate threshold value of 50mL / min! /, And the internal bleeding does not occur! / ! /, Can be determined, and the blood return pressure limit P1 or the blood return speed limit value can be increased. It may be a thread-to-thread combination.
  • the recovery judgment flow rate threshold can be set in the range from 20mL / min to 2/3 of the set speed and the smaller one of 60mL / min.
  • step S429 the blood return restriction pressure P1 is returned to 200 mmHg, and the flag F is set.
  • step S416 the blood return speed setting value reduced to 60 mL / min may be returned to the original 90 mL / min.
  • the above condition (5) can be determined based on the point P3 in FIG.
  • the rotational speed N is determined by accelerating / decelerating based on the donor pressure Pd. This acceleration / deceleration is defined based on the flow rate conversion value, and updated and controlled at intervals of about 50 msec. This interval can be set in the range of 25 200 msec.
  • Donor pressure When Pd is over the set value of –100 5 mmHg and less than the set value of –50 + 20 mmHg, the range up to the set speed is the acceleration of the set value of + l + 10 mL / min / sec. Accelerate within.
  • the flow rate is 0 with a deceleration of -100 10111/111 ⁇ / 36 ( set value) Decelerate within the range up to.
  • the rotation speed N of the blood pump 28 is the initial value in terms of discharge volume, and when the set speed is 20 mL / min or more, 20 mL / min force is started. However, if it is less than 20 mL / min, start from the set speed and accelerate each.
  • blood return limiting pressure P1 is set to 200 mmHg in the initial state at the time of blood return.
  • the donor pressure Pd is equal to or higher than the set value of + 220 + 300 mmHg, it is determined that the pressure is abnormal, and the rotation of the blood pump 28 is stopped, and a predetermined abnormality handling process is performed.
  • Donor pressure If 1 is greater than the set value of +155 + 300111111 ⁇ 3 ⁇ 4 and less than the set value of +220 + 300mmHg, it will decelerate at the set speed of ⁇ 100 10111 and / 111 ⁇ / 36 ( set value).
  • the one-arm collection method in which blood is returned after blood collection is taken as an example.
  • the present invention is of course applicable to a bi-arm continuous method in which blood collection and blood return are performed simultaneously. It is.
  • a blood collection pressure sensor and a blood return pressure sensor, and a suction pump and a discharge pump may be provided independently.
  • the donor pressure Pd is more than the set value of +100 + 200mmHg, +200 +30
  • control procedure of the blood pump 28 based on the return limiting pressure P1 is not limited to this.

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Cardiology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • External Artificial Organs (AREA)

Abstract

La présente invention concerne un appareil (10) destiné à recueillir un composant sanguin, qui comprend les éléments suivants : un circuit de retour de sang permettant de renvoyer un composant sanguin défini au donneur, après séparation du sang recueilli auprès du donneur ; une pompe sanguine à vitesse variable (28) destinée à introduire le composant sanguin dans le circuit de retour de sang ; un capteur de pression du donneur (38) permettant de détecter la pression du donneur Pd ; une unité de détection de vélocité (98) pour détecter la vélocité V du retour sanguin dans le circuit de retour de sang ; et une unité de contrôle (26) destinée à actionner la pompe sanguine (28) en fonction de la pression du donneur Pd et de la vélocité du retour sanguin V. Lorsque la pression du donneur Pd excède une ligne seuil (502) qui a été déterminée en fonction du nombre cumulatif de rotations A de la pompe sanguine (28) ou du temps de retour du sang de passage durant le lancement du retour de sang et l'accélération de la pompe sanguine (28), l'unité de contrôle (26) diminue la pression de retour sanguin limitée Pl ou la valeur limite de la vélocité du retour sanguin V.
PCT/JP2007/071698 2006-11-10 2007-11-08 Appareil de collecte de composant sanguin WO2008056733A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2008543116A JP4979709B2 (ja) 2006-11-10 2007-11-08 血液成分採取装置

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
JP2006305157 2006-11-10
JP2006-305157 2006-11-10
JP2007-087015 2007-03-29
JP2007087015 2007-03-29

Publications (1)

Publication Number Publication Date
WO2008056733A1 true WO2008056733A1 (fr) 2008-05-15

Family

ID=39364544

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2007/071698 WO2008056733A1 (fr) 2006-11-10 2007-11-08 Appareil de collecte de composant sanguin

Country Status (2)

Country Link
JP (2) JP4979709B2 (fr)
WO (1) WO2008056733A1 (fr)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014041600A1 (fr) * 2012-09-11 2014-03-20 テルモ株式会社 Dispositif de séparation des composants sanguins
WO2014041599A1 (fr) * 2012-09-11 2014-03-20 テルモ株式会社 Dispositif de séparation des composants sanguins
US10112003B2 (en) 2012-03-27 2018-10-30 Terumo Kabushiki Kaisha Blood component separation device
EP3593830A1 (fr) * 2018-07-13 2020-01-15 Fenwal, Inc. Système et procédé de réglage dynamique de débit de fluide en réponse à la pression
WO2021177423A1 (fr) * 2020-03-05 2021-09-10 テルモ株式会社 Dispositif de circulation extracorporelle

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2902046B1 (fr) * 2012-09-26 2018-01-10 Terumo Kabushiki Kaisha Dispositif de commande pour dispositif de maintien des fonctions vitales
CN107811645A (zh) * 2017-12-10 2018-03-20 苏理锋 抽取血管中血液的机器

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0538364A (ja) * 1991-08-06 1993-02-19 Terumo Corp 血漿採取装置
JP2006034721A (ja) * 2004-07-28 2006-02-09 Terumo Corp 血液成分採取装置
JP6057250B2 (ja) * 2012-09-10 2017-01-11 国立大学法人名古屋大学 希土類金属の回収方法および回収装置

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3584880D1 (de) * 1984-06-29 1992-01-23 Baxter Int Verfahren und vorrichtung zum steuern der entnahme und anschliessenden infusion von blut.
US6428712B1 (en) * 2000-04-06 2002-08-06 Hemasure, Inc. Gravity driven liquid filtration system and method for filtering biological liquid
JP4059722B2 (ja) * 2001-08-10 2008-03-12 株式会社クラレ 血液処理装置
JP2005110748A (ja) * 2003-10-03 2005-04-28 Terumo Corp 血液成分採取装置

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0538364A (ja) * 1991-08-06 1993-02-19 Terumo Corp 血漿採取装置
JP2006034721A (ja) * 2004-07-28 2006-02-09 Terumo Corp 血液成分採取装置
JP6057250B2 (ja) * 2012-09-10 2017-01-11 国立大学法人名古屋大学 希土類金属の回収方法および回収装置

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10112003B2 (en) 2012-03-27 2018-10-30 Terumo Kabushiki Kaisha Blood component separation device
WO2014041600A1 (fr) * 2012-09-11 2014-03-20 テルモ株式会社 Dispositif de séparation des composants sanguins
WO2014041599A1 (fr) * 2012-09-11 2014-03-20 テルモ株式会社 Dispositif de séparation des composants sanguins
CN104602720A (zh) * 2012-09-11 2015-05-06 泰尔茂株式会社 血液成分分离装置
JP5863978B2 (ja) * 2012-09-11 2016-02-17 テルモ株式会社 血液成分分離装置
US9452254B2 (en) 2012-09-11 2016-09-27 Terumo Kabushiki Kaisha Method for controlling a blood component separation device including temporarily storing a component in a container
US10195319B2 (en) 2012-09-11 2019-02-05 Terumo Kabushiki Kaisha Blood component separation device
US10426886B2 (en) 2012-09-11 2019-10-01 Terumo Kabushiki Kaisha Set of containers for use on a blood component centrifugal separator
EP3593830A1 (fr) * 2018-07-13 2020-01-15 Fenwal, Inc. Système et procédé de réglage dynamique de débit de fluide en réponse à la pression
US11819805B2 (en) 2018-07-13 2023-11-21 Fenwal, Inc. System and method of dynamically adjusting fluid flow rate in response to pressure
WO2021177423A1 (fr) * 2020-03-05 2021-09-10 テルモ株式会社 Dispositif de circulation extracorporelle

Also Published As

Publication number Publication date
JP2012139546A (ja) 2012-07-26
JPWO2008056733A1 (ja) 2010-02-25
JP4979709B2 (ja) 2012-07-18
JP5442796B2 (ja) 2014-03-12

Similar Documents

Publication Publication Date Title
JP5442796B2 (ja) 血液成分採取装置
JP4861649B2 (ja) 血液成分採取回路および血液成分採取装置
JP2007020961A (ja) 血液処理装置
JP3850429B2 (ja) 血液成分分離装置
US10195319B2 (en) Blood component separation device
JP2008067779A (ja) 血液成分採取装置、ディスポーザブルユニット及び装置本体
JP4956528B2 (ja) 血液成分採取装置
JP2005110748A (ja) 血液成分採取装置
JP4681395B2 (ja) 血液成分採取装置
JP4558401B2 (ja) 血液成分採取装置
JP4916905B2 (ja) 血液成分採取装置
JP4516043B2 (ja) 血液成分採取装置
JP4500618B2 (ja) 血液成分採取装置
JP4594029B2 (ja) 血液成分採取装置
JP5883436B2 (ja) 血液成分採取装置
JP4892290B2 (ja) 血液成分採取装置
JP4459263B2 (ja) 体外血液処理方法及び装置
JP4607803B2 (ja) 血液成分採取装置
JP4607508B2 (ja) 血液成分採取装置
JP2007111306A (ja) 血液成分採取装置
JP4871496B2 (ja) 血液成分採取装置
JP2007050078A (ja) 血液成分採取装置
JP4758663B2 (ja) 血液成分採取装置
JP2008245942A (ja) 血液成分採取装置
JP2006034467A (ja) フィルター監視システムおよび血小板採取装置

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 07831429

Country of ref document: EP

Kind code of ref document: A1

WWE Wipo information: entry into national phase

Ref document number: 2008543116

Country of ref document: JP

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 07831429

Country of ref document: EP

Kind code of ref document: A1