JP4481919B2 - Blood component collection device - Google Patents

Description

  The present invention relates to a blood component collection apparatus including a centrifuge for centrifuging blood collected from a 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. In component blood collection, a predetermined component is extracted by centrifuging blood collected from a donor, and other components are returned to the donor. As a result, the necessary components (plasma and platelets) can be collected more than the whole blood, and the other components are returned, so that the burden on the donor can be reduced. Moreover, a blood component collection apparatus for automatically performing such component blood collection has been put into practical use.

  The blood component collection device has a main body having a predetermined control mechanism and a blood collection kit attached to the main body. The blood collection kit includes a bag for storing predetermined components of blood, a centrifuge, a tube for conducting blood, and the like. The blood collection kit is a disposable product that is exchanged for each donor and is sterilized in advance.

  When obtaining a platelet preparation in a blood component collection device, blood collected from a donor is introduced into a centrifuge and separated into plasma, buffy coat and erythrocytes by centrifugal force. The centrifuge has a stator fixed to the apparatus main body and a rotor that is rotated by a motor, and a seal is provided between the stator and the rotor to keep an internal blood storage space airtight. While the seal is in sliding contact with the rotor, it prevents sterilized air, blood or blood components in the blood storage space from leaking out and outside air from entering the blood storage space, and maintains the blood collection kit in a sterilized state.

  On the other hand, if the seal cannot be properly maintained in an airtight state due to unforeseen circumstances, blood may leak and scatter as the bowl rotates. In such a case, the centrifuge is stored. The leakage of blood or the like can be detected by a liquid leakage sensor provided on the inner wall of the small room, and the apparatus can be stopped (see, for example, Patent Document 1). Therefore, when leakage of blood or the like is not left unattended and sterility in the circuit cannot be maintained, blood collection can be stopped at the discretion of the operator or apparatus.

JP 2005-81087 A

  By the way, in the blood component collection device described in the above-mentioned Patent Document 1, it is possible to detect the leakage of blood only after the blood or the like leaks from the centrifuge and then the blood or the like comes into contact with the liquid leakage sensor. Since it takes several minutes for the blood to come into contact with the seal and leak out of the centrifuge, detection may take time as a result.

  The present invention has been made in consideration of such problems, and an object of the present invention is to provide a blood component collection device that can more quickly detect leakage of blood or the like from a centrifuge.

The blood component collection apparatus according to the present invention detects a predetermined speed component by centrifuging blood collected from a donor, a motor that rotates the centrifuge, and a rotational speed of the motor. a speed sensor monitors the rotational speed by the signal of the sensor, based on the change in the rotational speed have a, an abnormality monitoring unit that performs a predetermined error output, the abnormality monitoring unit, the default speed or predetermined The error output is performed when the amount of decrease and the decrease time of the rotation speed with respect to the average value of the rotation speed within the period are equal to or greater than a predetermined threshold value .

That is, when blood or the like enters the seal provided between the stator and rotor of the centrifuge, the sliding load of the seal fluctuates, so that the rotational speed of the motor also fluctuates. Therefore, the blood leak from the seal can be detected quickly by monitoring the signal of the speed sensor that detects this. In addition, since the abnormality monitoring unit outputs an error when the rotation speed reduction amount and reduction time with respect to the predetermined rotation speed or the rotation speed average value within a predetermined period are equal to or greater than a predetermined threshold value, there is no influence of noise or the like. Detection is possible. The error output here is in a broad sense and includes a warning output, and the output format includes audio output, image output, communication output to other devices, and the like.

  In this case, when the threshold for the amount of decrease is 5 to 20 rpm and the threshold for the decrease time is 1 to 5 seconds, appropriate detection is possible.

  A voltage monitoring unit that detects a voltage supplied to the motor, and the abnormality monitoring unit is set so as not to perform the error output when the voltage is changed with reference to a signal of the voltage monitoring unit; Good. Thereby, the case where a rotation speed fluctuates with the fluctuation | variation of a supply voltage can be distinguished, and a misdetection can be suppressed.

  When blood or the like enters a seal provided between the stator and the rotor of the centrifuge, the sliding load of the seal fluctuates, so that the rotational state amount of the motor also fluctuates. Therefore, according to the blood component collection device of the present invention, blood leakage from the seal can be detected promptly and reliably by monitoring the rotational state amount of the motor by an appropriate sensor signal. As the rotational state quantity, the rotational speed, drive current, etc. may be monitored.

  Hereinafter, embodiments of the blood component collection device according to the present invention will be described with reference to FIGS.

  As shown in FIG. 1, a blood component collection device 10 according to the present embodiment has 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 column 16a, the box-shaped mechanism main unit 15, the first column 16a and the second column 16b extending upward from the left and right sides of the mechanism unit 15. On the right side of the weighing scale 18, the monitor 20 provided on the upper end of the second support column, the bag detection sensor 21 for detecting the presence or absence of the multi-chamber bag 126 provided on the right side of the first support column 16a, and the second support column 16b. It has a sensor 23a for detecting the presence / absence of the sterilization filter 114 provided, and a sensor 23b for detecting the presence / absence of the bubble removal chamber 112 and the dripping of the 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 body 15 includes a left control mechanism 22 and a right centrifugal mechanism 24. 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 (circuit switching means) 36a, 36b, 36c, 36d, 36e, 36f, 36g, a donor pressure sensor 38, and a system pressure sensor 40. As 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 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 can be driven in a non-contact state with respect to the blood. is there. 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 turbidity sensor 32 is a sensor that detects the turbidity of the liquid passing through the sandwiched tube. The bubble sensors 34a to 34f are sensors that detect the presence or absence of bubbles or liquid mixed in the liquid passing through the sandwiched tube. The clamps 36a to 36g press and close the sandwiched tube from both sides, or open and communicate with each other, and serve 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 integrating and arranging many portions of the tubes of the blood collection kit 14. The cassette housing 42 is fitted into the upper surface of the control mechanism unit 22 to correspond to a predetermined tube. The clamps 36a to 36g are arranged to be openable and closable.

  The donor pressure sensor 38 is a sensor that measures a donor pressure Pd indicating a blood collection pressure by inserting a part of a blood collection path system (blood collection circuit) 14a (see FIG. 4) in the blood collection kit 14. The system pressure sensor 40 is a sensor into which a part of the processing path system 14b (see FIG. 4) is inserted and measures a system pressure (in-circuit pressure) Ps indicating a pressure in the circuit. In addition, since arrangement | positioning of the tube in the blood collection kit 14 of the state set to the apparatus main body 12 is not the summary of this invention, a part of tube is abbreviate | omitted and illustrated in FIG.

  As shown in FIG. 2, the centrifuge mechanism 24 is a mechanism that is equipped with a centrifuge bowl (centrifuge) 120 of the blood collection kit 14 and centrifuges blood introduced into the centrifuge bowl 120. The centrifuge bowl 120 includes a truncated cone-shaped rotor 50 whose diameter is expanded downward, and a fixed cap (stator) 52 provided on an upper portion of the rotor 50. The fixing cap 52 includes a circular plate 52a, a columnar body 52b protruding upward from the center, an introduction port 52c and a discharge port 52d protruding laterally from the upper and central portions of the columnar body 52b, and the columnar body 52b. And a flange 52e protruding in the circumferential direction from the lower portion. The fixing cap 52 is fixed to the centrifugal separation mechanism portion 24 through the concave portion of the opening / closing cover 58c between the upper surface of the circular plate 52a and the flange 52e in the cylindrical body 52b. The introduction port 52c and the discharge port 52d are portions for introducing and discharging blood and the like to the centrifuge bowl 120.

  The rotor 50 includes a transparent resin plate outer plate 50a, a conical white reflecting plate 50b provided on the inner side, a bottom plate 50c, and a tubular body that extends in the vertical direction at the center and communicates with the introduction port 52c. 50d. A blood storage space 54 into which blood is introduced is formed between the outer plate 50a and the reflecting plate 50b. The blood storage space 54 has a shape (tapered shape) in which the inner and outer diameters gradually decrease upward, and the lower portion thereof passes through a substantially disk-shaped channel formed along the bottom of the rotor 50. The tube body 50d communicates with the lower end opening, and the upper portion communicates with the discharge port 52d. Between the fixed cap 52 and the rotor 50, there is provided a seal 56 that keeps the rotor 50 airtight and rotatably holds it.

  The volume of the blood storage space 54 is, for example, about 100 to 350 mL, and the radius of the bottom plate 50 c is, for example, about 55 to 65 mm.

  The centrifuge mechanism 24 has an upper bowl mounting part 58 and a lower motor part 60. The bowl mounting portion 58 includes a housing 58a that forms a space in which the centrifugal bowl 120 is disposed, a turntable 58b into which the bottom plate 50c of the centrifugal bowl 120 is fitted, a circular plate 52a of the fixed cap 52, a cylindrical body 52b, and a flange. A transparent opening / closing cover 58c for fixing 52e, an O-ring 58d provided at an edge of the opening / closing cover 58c, two liquid leak sensors 61a and 61b, and an optical sensor 62 are provided. The open / close cover 58c has a recess, and the flange 52e is fitted into the recess to be fixed.

  The O-ring 58d keeps the inside of the housing 58a fluid-tight and prevents splashing to the outside even when blood or the like leaks from the centrifuge bowl 120 due to an unexpected situation.

  The liquid leak sensors 61a and 61b are thin strip sensors, and can detect adhesion of liquid. The liquid leak sensor 61a is disposed at almost the entire circumference of the inner wall surface of the housing 58a at the height position of the seal 56 on the inner wall surface of the housing 58a. Further, the liquid leak sensor 61b is disposed at almost the entire circumference of the inner wall surface of the housing 58a at the height position of the bottom plate 50c of the centrifuge bowl 120. According to such liquid leak sensors 61a and 61b, when blood or the like leaks from the centrifuge bowl 120, it is possible to detect the leak due to adhesion of the blood or the like, and to take corresponding appropriate measures. .

  The motor unit 60 includes a motor 64 that is set in a direction in which the rotation shaft 64a is directed vertically upward, and a speed sensor 65 that detects a rotation speed (rotation state amount) ω of the motor 64. The speed sensor 65 detects a plurality of teeth 64b (or shade marks or the like) provided around the rotation shaft 64a in a non-contact manner, and detects the rotation speed ω of the motor 64 from the period of the presence or absence of the teeth 64b. The non-contact detection does not affect the rotation of the motor 64. In general, since the rotation speed is widely detected by various devices, it can be detected easily and with high accuracy by an inexpensive sensor. The speed sensor 65 may be any sensor that can detect the rotational speed ω of the motor 64, and may be replaced with, for example, a rotary encoder or a resolver.

  The rotating shaft 64a is connected to the bottom surface of the turntable 58b, and the centrifuge bowl 120 can rotate under the action of the motor 64. The motor 64 can rotate in the range of about 3000 to 6000 rpm, and the set rotational speed is set to about 4200 to 5800 rpm, for example. Thereby, the blood in the blood storage space 54 is separated from the inner layer into a plasma layer (PPP layer) 70, a buffy coat layer (BC layer) 72, and a red blood cell layer (CRC layer) 74.

  The optical sensor 62 includes a projector 62a that generates light (for example, laser light), a light receiver 62b that receives light reflected by the reflecting plate 50b, and a mirror 62c that adjusts the direction of the optical path. The light projector 62a projects light to the reflecting plate 50b through the blood storage space 54, and the light reflected by the reflecting plate 50b returns through substantially the same path, is received by the light receiving device 62b, and is converted into an electrical signal corresponding to the amount of received light. The

  At this time, the projected light and the reflected light pass through the blood components in the blood storage space 54, respectively, but depending on the position of the interface B between the plasma layer 70 and the buffy coat layer 72, the projected light and the reflected light are transmitted. Since the abundance ratios of the respective blood components at the transmitting position are different, their transmittance changes. As a result, the amount of light received by the light receiver 62b varies and can be detected as a change in output voltage. The interface of the blood component detected by the optical sensor 62 is not limited to the interface B, and may be the interface between the buffy coat layer 72 and the red blood cell layer 74, for example.

  Each of the layers 70 to 74 in the blood storage space 54 has a different color depending on the blood component, and the red blood cell layer 74 is red with the color of the red blood cells. For this reason, from the viewpoint of improving measurement accuracy, there is a range suitable for the wavelength of the projection light, and the wavelength range is preferably about 750 to 800 nm, for example.

  As shown in FIG. 3, 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. 30, the motor 64 and the clamps 36a to 36g are controlled. 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.

  Further, the control unit 26 includes an input interface 84 that performs input control of each sensor, a monitor interface 86 that performs input / output of the monitor 20, and a sensor input circuit 87 that performs input processing of the speed sensor 65. The control unit 26 further includes a mode control unit 88 that controls blood collection processing operation in cooperation with each functional unit, an abnormality monitoring unit 90 that monitors abnormalities based on input signals of each sensor, and a predetermined program. And a storage unit 92 that stores data, a timer 94, a communication unit 96 that performs data communication with an external device, and a voltage monitoring unit 98. The operation of the abnormality monitoring unit 90 will be described later.

  The control unit 26 includes a power supply circuit 99 that generates a predetermined control voltage Vc (for example, DC5V, DC24V, etc.) from an external power supply (for example, AC 100V), and the control voltage Vc is supplied to each functional unit. Yes. The voltage monitoring unit 98 is connected to the power supply circuit 99 and monitors the external power supply and the control voltage Vc.

  Some of the functions in the control unit 26 are realized by reading and executing a program recorded in the storage unit 92 by a CPU (not shown).

  As shown in FIG. 4, 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 for puncturing a donor, a tube 104 having 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, and the tube 104 A chamber 106 provided in the middle of the container, 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 connecting needle A tube 110 connected to 108, and a bubble removal chamber 112 and a sterilization filter (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 chamber 106 removes bubbles and microaggregates in the blood passing through the tube 104. A short tube 118 branched from the tube 104 is provided at one end of the chamber 106. The end of the tube 118 is connected to a breathable and bacteria-impermeable filter (not shown) and is inserted into the donor pressure sensor 38 so that the donor pressure Pd can be measured.

  The anticoagulant container 107 connected to the anticoagulant container connecting needle 108 stores an anticoagulant such as ACD-A solution. 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 is passed through the tube 110 and the branch joint 116. An anticoagulant is mixed in the blood in 104. A bubble sensor 34 a 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 communicate with each other by opening the clamp 36a. Two bubble sensors 34e and 34f are attached to the tube 104 in series, and bubbles and air can be reliably detected.

  The processing path system 14b has a centrifuge bowl 120, a plasma collection bag 122, a platelet collection bag 124, an intermediate bag 126a, an air bag 126b, a bag 128, and a leukocyte removal filter 130. The centrifuge bowl 120 has been described in detail with reference to FIG.

  The plasma collection bag 122 and the 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 the hook 18a of the weighing scale 18 (see FIG. 1), and the weight of the stored plasma can be measured. The 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 concentrated platelets. The air bag 126b is a container for temporarily storing aseptic 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 from the hook 21a of the bag detection sensor 21 (see FIG. 1).

  When blood is collected, air in the blood storage space 54 of the centrifuge bowl 120 is transferred into the air bag 126b and stored. In the blood return process, the air stored in the air bag 126b is returned to the blood storage space 54, and a predetermined blood component is returned to the donor.

  The bag 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 is completed.

  The plasma collection bag 122, the platelet collection bag 124, the intermediate bag 126a, the air bag 126b, and the bag 128 are each laminated with a flexible sheet material made of resin (for example, soft polyvinyl chloride), and the peripheral portions thereof are fused. (Thermal fusion, high-frequency fusion, ultrasonic fusion, etc.) or a bag formed by bonding with an adhesive is used.

  In addition, as a sheet material used for the platelet collection bag 124, it is more preferable to use a material excellent in gas permeability in order to improve platelet storage stability. As such a sheet material, for example, polyolefin, DnDP plasticized polyvinyl chloride, or the like 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 is clear from FIG. 1, the leukocyte removal filter 130 is disposed at a position lower than the intermediate bag 126 a and higher than the platelet collection bag 124.

  Next, tubes that connect each component device of the processing path system 14b will be described. A tube 140 is connected between the branch joint 102 which is the end of the processing path system 14 b and the inlet 52 c of the centrifuge bowl 120. The tube 140 is attached to the blood pump 28. Therefore, by rotating the blood pump 28 forward, 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 52 d of the centrifuge bowl 120, and the tube 142 is branched into three branches 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 to the turbidity sensor 32 and the bubble sensor 34d.

  The tube 146 is connected to the air bag 126b, and is attached to the clamp 36e along the way. The end of the tube 148 is connected to a breathable and germ-impermeable filter (not shown) and is 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 a branch joint 152 is provided in the middle of the tube 150, and is connected to the intermediate bag 126 a via the tube 154. The tube 154 is attached to the 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. At the end of the leukocyte removal filter 130, a filter 160 branched from the tube 156 is provided. The filter 160 includes a 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. A tube 164 between the branch joint 162 and the branch joint 166 is attached to the clamp 36f. A clamp 36 b is attached to the tube 168 in the vicinity of the branch joint 102.

  The platelet collection bag 124 and the bag 128 are connected by a tube 158.

  The blood collection kit 14 configured in this manner is subjected to a predetermined sterilization process in advance. 4, illustration of the cassette housing 42 in which the tubes of the blood collection kit 14 are concentrated and the filter cassette 170 (see FIG. 1) that holds a part of the tubes and the filter 160 is omitted.

  Next, a procedure for collecting blood components by the blood component collecting device 10 will be described with reference to FIGS.

  First, predetermined initial processing is performed in step S1 of FIG. As an initial process, the blood collection needle 100 to the chamber 106 of the tube 110 and the tube 104 are primed with an anticoagulant, and then the blood collection needle 100 is punctured into the blood vessel of the donor. Thereafter, the component blood collection process is started by operating the color touch panel 20a of the monitor 20. Subsequent procedures are automatically performed mainly under the action of the control unit 26.

  In step S2, a first plasma collection step is performed. This first plasma collection step is a step of collecting plasma obtained by introducing blood into the blood storage space 54 of the centrifuge bowl 120 and centrifuging it into the plasma collection bag 122.

  Specifically, blood is collected from the donor by rotating the blood pump 28 forward at a prescribed blood collection speed. This blood collection speed is set to 60 mL / min, for example. Simultaneously with the blood collection, the anticoagulant pump 30 is operated to supply the anticoagulant via the tube 110 and mix it into the collected blood.

  The blood (blood added with an anticoagulant) is transferred through the tube 104 and introduced into the blood storage space 54 of the rotor 50 through the tube 50d from the inlet 52c of the centrifugal bowl 120. At this time, 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 50 is started in a state where a predetermined amount of blood is introduced into the blood storage space 54. That is, the motor 64 is driven and the rotor 50 is controlled to rotate at a predetermined rotational speed. The target rotational speed of the rotor 50 is, for example, about 4200 to 5800 rpm. Further, the rotational speed of the rotor 50 is kept constant until step S9. By the rotation of the rotor 50, the blood introduced into the blood storage space 54 is separated from the inside into three layers: a plasma layer 70, a buffy coat layer 72, and a red blood cell layer 74. After the second cycle, the centrifugal motor 64 is driven simultaneously with the blood pump 28.

  In 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 142 has changed from air to plasma, the clamp 36e is closed and the clamp 36c is opened. When blood exceeding the capacity of the blood storage space 54 is introduced into the blood storage space 54, plasma flows out from the outlet 52d of the centrifuge bowl 120. Therefore, this timing is detected by the bubble sensor 34d and a clamping operation is performed. In addition, the plasma is switched to be introduced into and collected in the plasma collection bag 122 through the tube 150. The weight of the plasma introduced into the plasma collection bag 122 is measured by the 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.

  In step S4, a constant-speed plasma circulation process is performed. The constant-speed plasma circulation step is a step of circulating the plasma in the plasma collection bag 122 at a constant speed in a circulation circuit including the blood storage space 54. That is, the clamp 36a is closed, the clamp 36b is opened, and the anticoagulant pump 30 is stopped. Thereby, while collecting blood temporarily, the path | route which circulates the plasma in the plasma collection bag 122 is formed. This circulation circuit reaches the blood storage space 54 from the plasma collection bag 122 through the tubes 164, 168 and 140, and plasma flowing out from the outlet 52 d of the centrifuge bowl 120 flows through the tubes 142 and 150 to the plasma collection bag 122. It is a route to collect in. In a state where this circulation circuit is formed, the blood pump 28 is circulated at a predetermined speed (for example, 200 mL / min). After performing this constant-speed plasma circulation process for a predetermined time, the process proceeds to step S5.

  In step S5, a second plasma collection step is performed. In the second plasma collection step, plasma collection and centrifugation are performed in the same manner as in the first plasma collection step. Thereby, as the amount of red blood cells in the blood storage space 54 increases, that is, as the layer thickness of the red blood cell layer 74 increases, the interface B gradually approaches the rotating shaft 64a of the centrifuge bowl 120. After confirming that the interface B has reached a predetermined level based on the detection signal, the process proceeds to step S6.

  In step S6, an accelerated plasma circulation process is performed. The accelerated plasma circulation step is a step of circulating the plasma in the plasma collection bag 122 in the circulation circuit while accelerating the plasma in the blood storage space 54. After the plasma circulation speed reaches the predetermined speed, the process proceeds to step S7.

  In step S7, a third plasma collection step is performed. In the third plasma collection step, plasma is collected in the same manner as in the first and second plasma collection steps. After confirming that a predetermined amount of plasma has been collected in the plasma collection bag 122, the process proceeds to step S8.

  In step S8, a platelet collecting step is performed. In the platelet collection step, the plasma in the plasma collection bag 122 is circulated while accelerating in the blood storage space 54 at the first acceleration, and then changed to a second acceleration larger than the first acceleration. It is a step of circulating (acceleration by acceleration), allowing platelets to flow out from the blood storage space 54, and collecting (storing) concentrated platelets in the intermediate bag 126a. After performing a predetermined operation in the platelet collecting step, the clamp 36e is opened, the other clamps 36a to 36d, 36f and 36g are closed, and the blood pump 28 is stopped.

  In step S9, the rotational speed of the motor 64 is controlled to decelerate and stop the rotor 50.

  In step S10, the blood return process is started. The blood return process is a process of returning blood components (mainly red blood cells and white blood cells) remaining in the blood storage space 54 of the rotor 50 to the donor. That is, the clamp 36a and the clamp 36e are opened, and the blood pump 28 is reversed at a predetermined rotation speed (for example, 90 mL / min). As a result, the blood component remaining in the blood storage space 54 of the rotor 50 is discharged from the inlet 52c of the centrifuge bowl 120 and returned (returned) to the donor via the tube 104 (blood collection needle 100). Thereafter, the blood return process is terminated based on a predetermined termination condition.

  In 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.

  In the final cycle, the filtration process is started in step S5. The filtration step is a step in which the concentrated platelets temporarily collected (stored) in the intermediate bag 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. . Concentrated platelets from which white blood cells have been removed are stored in a platelet collection bag 124.

  Next, the abnormality monitoring process of the abnormality monitoring unit 90 will be described with reference to FIG. This abnormality monitoring process is performed independently and in parallel with the control of the mode control unit 88 shown in FIG. 3 based on a technique such as multitasking.

  In step S101 in FIG. 6, the control voltage Vc supplied to the motor driver 80 and the motor 64 is monitored based on the signal obtained from the voltage monitoring unit 98.

  In step S102, the rotational speed ω of the motor 64 is monitored based on a signal obtained from the speed sensor 65 via the sensor input circuit 87.

  In step S103, it is checked whether or not the rotational speed ω has changed. Specifically, referring to the data of the past rotational speed ω, the rotational speed ω when the decrease amount and the decrease time are equal to or greater than a predetermined threshold with respect to the predetermined rotational speed or the average rotational speed value in the past predetermined period. When the control voltage is not changed, the process proceeds to step S105. Thus, by making a determination based on the reduction amount and the reduction time, it is possible to perform reliable detection without the influence of noise or the like. Therefore, the noise 180 shown in FIG. 7A is eliminated.

  Moreover, in the general blood component collection device 10, as described above, the target rotational speed of the rotational speed ω is about 4200-5800 rpm, the volume of the blood storage space 54 of the centrifuge bowl 120 is about 100-350 mL, and the radius of the bottom plate 50c is 55. It is about ~ 65mm. When the motor 64 is rotated under such conditions, an appropriate detection is obtained when the threshold for the amount of decrease in the rotational speed ω is 5 to 20 rpm (for example, 10 rpm) and the threshold for the decrease time is 1 to 5 seconds (for example, 2 seconds). It becomes possible.

  By the way, two cases are assumed as the situation where the rotational speed ω decreases. The first case corresponds to the time t1 in FIGS. 7A and 7B, for example, when the other electrical equipment connected to the same power supply system is started, and the supply voltage to the blood component collection device 10 Is temporarily reduced, and this is a case where the control voltage Vc in the control unit 26 is lowered. In this case, since the power supplied to the motor 64 also temporarily decreases, the rotational speed ω can decrease. In this case, there is no problem even if the rotation of the motor 64 is continued.

  The second case corresponds to the time t2 in FIGS. 7A and 7B, and blood or plasma or the like enters the seal 56 of the centrifuge bowl 120 due to an unexpected situation. This is a case where the load increases. In this case, the rotational speed ω is restored in a relatively short time by a predetermined feedback action, but in some cases, the rotational speed ω may not be restored to the original speed in a relatively short time. However, in any case, blood or the like may remain in the seal 56, and there is a concern that blood or the like may leak if left untreated.

  According to step S103, the process moves to step S104 in both cases of times t1 and t2 corresponding to the first case and the second case.

  In step S104, it is checked whether or not the control voltage Vc has changed. Specifically, similarly to the investigation of the change (decrease) in the rotational speed ω in step S103, the control voltage Vc changes when a state where the amount of decrease is equal to or greater than a predetermined value continues for a predetermined time or longer. It can be judged. When the change of the control voltage Vc is recognized, the process proceeds to step S106, and when there is no change, the process proceeds to step S105. Accordingly, in correspondence with FIG. 7A and FIG. 7B, the process moves to step S106 in the first case indicated by time t1, and moves to step S105 in the second case indicated by time t2. Note that the determination in step S104 may be performed based on the voltage of the external power supply for blood component collection device 10 instead of control voltage Vc.

  In step S105, leak detection processing (error output) is performed as a subroutine processing. When this leak detection process is performed, the main routine process of FIG. 5 is temporarily stopped.

  As shown in FIG. 8, in the leak detection process, first, in step S201, the blood pump 28 and the anticoagulant pump 30 are stopped.

  In step S202, the clamps 36a to 36f are closed. At this time, the clamp 36e provided on the tube 146 leading to the air bag 126b is opened. Moreover, when filtering, the clamp 36g provided in the tube 156 of the filtration part is also opened.

  In step S203, an error alert display is performed. Specifically, a warning display is displayed on the color touch panel 20a of the monitor 20, and an appropriate alarm sound is generated from the speaker 20b. The color touch panel 20a displays, for example, a message “A decrease in the motor rotation speed has been detected. Check the centrifugal bowl.” And touch buttons “Stop” and “Continue”. The operator is prompted to select. Based on these indications and alarm sounds, the operator visually confirms the centrifuge bowl 120 through the transparent opening / closing cover 58c, and selects “stop” when leakage of blood or the like or excessive vibration of the seal 56 is observed. If there is no abnormality, “Continue” may be selected.

  Note that the processing in these steps S201 to S203 is a process of alerting the operator or donor in response to the change in the rotational speed ω, and is a kind of error processing. The output format of error processing due to the change in the rotational speed ω may be audio output, image output, communication output to other devices, or the like.

  In step S204, it is confirmed whether or not a predetermined interval time (for example, 2 min) has elapsed since the start of the leak detection process. That is, when the operator does not perform any operation, the process returns to step S203 every interval time to prompt the operation, and alerts are performed again. When the interval time has not elapsed, the process proceeds to step S205.

  In step S205, it is confirmed whether or not a predetermined time (preferably 3 to 15 minutes, more preferably 5 to 10 minutes, for example, 5 minutes) has elapsed since the start of the leak detection process. That is, since it is not appropriate to continue blood collection when the operator does not operate anything for a predetermined time, the process proceeds to step S208 where the motor 64 is stopped. When the elapsed time is less than the predetermined time, the process proceeds to step S206.

  In step S206, monitoring of the rotational speed ω is continued and whether or not there is a change in the rotational speed ω is confirmed as in step S103. When the rotational speed ω is confirmed, and it is recognized that the rotational speed ω has decreased again within a predetermined time (preferably 30 sec to 5 min, more preferably 1 to 3 min, eg 2 min) after the start of the leak detection process (see FIG. At time t3 of 7A), since it is determined that blood or the like has further entered the seal 56, the process proceeds to step S208 in which the motor 64 is stopped. If there is no change in the rotational speed ω, the process proceeds to step S207. It should be noted that at this time, only a predetermined notification may be sent to the operator.

  In step S207, it is confirmed whether or not the operator has performed a cancel operation. That is, when the operator operates the “Cancel” touch button based on the alert or the like displayed on the monitor 20, the operation is detected via the monitor interface 86, and the process proceeds to Step S208. If the cancel operation is not detected, the process proceeds to step S209.

  In step S208, the motor 64 and the centrifuge bowl 120 are stopped under the action of the motor driver 80. In addition, the clamp 36e is opened in advance to allow the tube 146 to communicate with the airbag 126b. After the motor stop process in step S208, the leak detection process in FIG.

  On the other hand, in step S209, it is confirmed whether or not the operator has continued the operation. In other words, when the operator operates the “continue” touch button based on the alert or the like displayed on the monitor 20, the process proceeds to step S210, and when the continuation operation is not detected, the process returns to step S204.

  In step S210, continuation processing is performed. That is, it is a case where it can be determined that there is no inconvenience even if the blood collection process is continued by a predetermined confirmation of the operator, and the process at the time of leak detection is exited. In this case, the operation of the blood pump 28 and the anticoagulant pump 30 is restarted, and the clamps 36a to 36g are opened and closed according to the mode at that time. Furthermore, the alerting output to the monitor 20 is stopped. Thereafter, the process returns to S101 in FIG. 6 to continue the abnormality monitoring process and resume the main routine process in FIG.

  On the other hand, in step S106 of FIG. 6 (when there is no change in the control voltage Vc), the signals of the liquid leak sensors 61a and 61b are monitored to determine whether blood or the like has adhered to the inner wall of the housing 58a. Check. If adhesion of blood or the like is detected, the process moves to step S105, and the leak detection process is performed as described above. If adhesion of blood or the like is not recognized on the inner wall of the housing 58a, the process proceeds to step S107.

  In step S107, the system pressure Ps obtained from the system pressure sensor 40 is monitored and compared with a predetermined threshold pressure Pε. When Ps> Pε, the process proceeds to step S109, and a predetermined system pressure abnormality process is performed. That is, when the system pressure Ps is excessively high, there is a concern that blood or the like may leak beyond the pressure resistance of the seal 56 if left as it is. Therefore, leakage of blood or the like is prevented by performing system pressure abnormality processing. When Ps ≦ Pε, the process proceeds to step S108. In the case of moving from the step S106 to the leak detection process in the step S105, or in the case of moving from the step S107 to the system pressure abnormality process in the step S109, the message displayed on the color touch panel 20a or a part of the process may be changed.

  In step S108, predetermined other abnormality monitoring processing is performed. As other abnormality monitoring processing, for example, abnormality monitoring of the donor pressure Pd obtained by the donor pressure sensor 38 can be cited. These other abnormality monitoring processes do not correspond to the leakage of blood or the like from the centrifuge bowl 120 and are not the gist of the present invention, and thus detailed description thereof is omitted. Thereafter, the process returns to step S101, and the abnormality monitoring process is continued.

  As described above, according to the blood component collection device 10 according to the present embodiment, when blood or the like enters the seal 56 of the centrifuge bowl 120, the sliding load of the seal 56 fluctuates. The speed ω also varies. Therefore, blood leakage from the seal 56 can be detected quickly by monitoring the rotational speed ω with the signal from the speed sensor 65. In addition, the time t2 (see FIG. 7A) at which the rotational speed ω has changed is the time immediately after blood or the like enters the seal 56, and it is considered that the blood has not yet leaked to the outside. (For example, steps S201 to S203 in FIG. 8) can be performed.

  Further, even when the amount of blood leaked from the seal 56 is extremely small and does not scatter to the inner wall of the housing 58a, the sliding resistance increases and the rotational speed ω changes when entering the seal 56. Even a small amount of leakage can be detected with high accuracy.

  Even if blood or the like adheres to the seal 56, the sterilization state of the blood collection kit 14 is not immediately impaired, and the processing speed is also quickly processed based on the fluctuation, so that the reliability of the blood collection operation is improved. Property can be further improved.

  The abnormality monitoring unit 90 refers to the control voltage Vc obtained from the voltage monitoring unit, and performs the leakage detection process in step S105 when the voltage Vc has not changed. When the speed ω fluctuates (for example, time t1 in FIG. 7A) can be distinguished, and erroneous detection can be suppressed.

  Furthermore, the blood component collection device 10 performs a double determination and one preventive measure for blood leaking from the seal 56 of the centrifuge bowl 120. That is, a determination based on a change in the rotational speed ω (step S103), a determination based on a process for recognizing that blood or the like has adhered to the inner wall of the housing 58a from the signals of the liquid leak sensors 61a and 61b (step S106), and a system pressure This is a preventive measure based on an excessive increase in Ps (step S107). Thereby, the sterilization state of the blood collection kit 14 can be maintained more reliably.

  In the above embodiment, the leakage of blood or the like is detected based on the change in the rotational speed ω of the motor 64. However, as indicated by the phantom line in FIG. 3, the current sensor 200 is connected to the power line of the motor driver 80. May be provided to detect the drive current (rotation state amount) Ic for the motor 64 and perform processing based on the change in the drive current Ic.

  That is, when blood or the like enters the seal 56 and the sliding resistance increases, the drive current Ic increases as shown in FIG. 7C if the rotation speed ω is maintained by a predetermined feedback system. Therefore, the branch determination performed based on the change in the rotational speed ω in step S103 may be performed based on the change in the drive current Ic. Thereby, blood leakage from the seal 56 can be detected quickly.

  Similarly to the rotational speed ω, the drive current Ic may decrease as the control power supply Vc decreases. Therefore, the monitoring determination of the control voltage Vc in step S104 may be similarly performed. Thereby, the change of the drive current Ic accompanying the fluctuation of the control voltage Vc can be distinguished as at time t1 in FIGS. 7B and 7C.

  The blood component collection device according to the present invention is not limited to the above-described embodiment, and it is needless to say that various configurations can be adopted without departing from the gist of the present invention.

It is a perspective view which shows the blood component collection device which concerns on this Embodiment. It is a partial cross section side view of a centrifuge mechanism part. It is a block block diagram of a control part. It is a circuit diagram of a blood collection kit. It is a flowchart which shows the procedure of the component blood collection performed with the blood component collection device. It is a flowchart of an abnormality monitoring process. FIG. 7A is a graph showing the change over time of the rotation speed of the motor, FIG. 7B is a graph showing the change over time of the control voltage, and FIG. 7C is a graph showing the change over time of the drive current of the motor. It is a flowchart of the process at the time of a leak detection.

Explanation of symbols

DESCRIPTION OF SYMBOLS 10 ... Blood component collection apparatus 14 ... Blood collection kit 20 ... Monitor 22 ... Control mechanism part 26 ... Control part 28 ... Blood pump 30 ... Anticoagulant pump 40 ... System pressure sensor 50 ... Rotor 52 ... Fixed cap 56 ... Seal 61a, 61b Liquid leakage sensor 64 Motor 65 Speed sensor 80 Motor driver 87 Sensor input circuit 88 Mode control unit 90 Abnormality monitoring unit 98 Voltage monitoring unit 99 Power supply circuit 100 Blood collection needle 108 Anticoagulant container connection Needle 120 ... Centrifugal bowl (centrifuge) 200 ... Current sensor

Claims (3)

A centrifuge for centrifuging blood collected from a donor to obtain a predetermined blood component;
A motor for rotating the centrifuge;
A speed sensor for detecting the rotational speed of the motor;
The rotational speed is monitored by a signal of the sensor, and the abnormality monitoring unit that performs a predetermined error output based on the change of the rotational speed,
I have a,
The abnormality monitoring unit performs the error output when the amount of reduction and the reduction time of the rotational speed with respect to a predetermined rotational speed or an average rotational speed value within a predetermined period are not less than a predetermined threshold value. . The blood component collection device according to claim 1 ,
The blood component collection apparatus according to claim 1, wherein a threshold value for the decrease amount is 5 to 20 rpm, and a threshold value for the decrease time is 1 to 5 seconds. The blood component collection device according to claim 1 or 2 ,
A voltage monitoring unit for detecting a voltage supplied to the motor;
The abnormality monitoring unit refers to the signal of the voltage monitoring unit, and does not perform the error output when the voltage is changing.

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