WO2008056733A1 - Apparatus for collecting blood component - Google Patents

Abstract

An apparatus (10) for collecting a blood component which comprises a blood return line for, after separating the blood collected from a donor, returning a definite blood component to the donor, a speed variable blood pump (28) for feeding the blood component to the blood return line, a donor's pressure sensor (38) for detecting the pressure of the donor Pd, a velocity detection unit (98) for detecting the blood return velocity V in the blood return line, and a controlling unit (26) for driving the blood pump (28) based on the donor's pressure Pd and the blood return velocity V. When the donor's pressure Pd exceeds a threshold line (502) that has been determined corresponding to the cumulative rotational number A of the blood pump (28) or the passage blood return time in the course of starting the blood return and accelerating the blood pump (28), the controlling unit (26) lowers the limited blood return pressure Pl or the limit value of the blood return velocity V.

Description

 Specification

 Blood component collection device

 Technical field

 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. Background art

 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, the blood collected from the donor is centrifuged to extract certain components, 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, reducing the burden on the donor. In addition, a blood component collection apparatus for automatically collecting such component blood has been put into practical use.

 [0003] In 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. 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.

 [0004] In order to reduce the time to restrain the donor in a series of component blood collection, it is desirable to perform blood collection and blood return as quickly as possible. Of course, there is a limit to speed.

 [0005] From this point of view, in Japanese Patent Publication No. 6-57250 (Japan) (WO86 / 00231A1), a test is performed in two flow ranges for each donor, and the resistance of the vein and the pressure 'flow rate based on the resistance are measured. A device that generates a curve and defines the rotational speed of the pump by this pressure-flow curve has been proposed.

[0006] However, depending on the puncture state of the needle, 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.

 [0007] In addition to the pain being noticed by the donor, 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.

 [0008] In general, if the donor feels pain or discomfort, blood return is interrupted, and if the donor accepts, the needle is removed, the needle is replaced, the needle is punctured again, and the remaining blood components are returned. To do. However, if the donor does not agree, the blood return will be stopped at that point and the blood component that was scheduled to be returned will be left in the circuit. In this case, the donor has lost blood components that could not be returned, so it is necessary to allow a predetermined period until the next blood donation. In addition, when returning the remaining blood components, it is necessary to perform puncture again avoiding the site of internal bleeding, which may be dissatisfied with the donor.

 [0009] Even if the donor does not feel uncomfortable during blood return, a sufficient blood collection speed cannot be obtained during blood collection in the next cycle, and blood is collected and returned before the necessary amount of blood components is obtained. You may have to stop blood.

 [0010] By the way, when blood is returned, even if internal bleeding occurs, the donor may not be immediately aware of it, and cannot take an appropriate action immediately. There are concerns about discomfort or anxiety for donors.

 [0011] Furthermore, there is no means for predicting or preventing the occurrence of internal bleeding that does not give a sense of incongruity to the donor.

 Disclosure of the invention

[0012] The present invention has been made in consideration of such problems, and provides a blood component collection apparatus that can prevent or moderately suppress the occurrence of internal blood in the blood return step in advance. For the purpose. [0013] A blood component collection device according to the present invention 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. A blood line; a variable-speed blood pump that sends blood components to the blood return line; a pressure sensor that detects the pressure of the blood return line; and a control unit that drives the blood pump. Is characterized by setting a limit value for the pressure or rate of return of the blood in accordance with one or more conditions based on the pressure obtained from the pressure sensor.

 [0014] According to such conditions, it is possible to predict the occurrence of internal bleeding that is not noticed by the donor, and internal bleeding that may give the donor a sense of incongruity by lowering the pressure of the blood return line or the limit value of the blood return rate. The ability to predict, prevent or moderate the occurrence of

 [0015] In this case, 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.

 [0016] In addition, when the control unit rotates the blood pump from the start of blood return! /, 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. As a result, it is possible to predict and prevent the occurrence of internal hemorrhage that can cause a sense of incongruity to the donor.

 [0017] Furthermore, one of the conditions may be a condition indicating a change in a mountain shape that decreases after the pressure increases.

 [0018] 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.

[0019] 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. When 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.

 [0020] The blood component collection device according to the present invention 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. A blood line; a variable-speed blood pump that sends blood components to the blood return line; a pressure sensor that detects the pressure of the blood return line; and a control unit that drives the blood pump. When the blood pump is rotated and blood return is started, 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.

 [0021] Thus, when the blood pump is rotating, the occurrence of internal hemorrhage that can give a sense of incongruity to the donor by decelerating or stopping the blood pump when the pressure exceeds a limiting threshold value or a stopping threshold value. Can predict, prevent, or moderately suppress S.

 [0022] Further, when the blood pump is rotated at the time of blood return! /, When the pressure gradient (the gradient of the pressure change) exceeds a predetermined gradient, the blood pump is decelerated or stopped, thereby It is possible to prevent or moderately suppress the occurrence of internal hemorrhage that can cause discomfort.

 [0023] 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.

 [0024] 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. When 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.

 Brief Description of Drawings

 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. 8] 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, and 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, and 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, and 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. 9] FIG. 9A is a diagram showing the contents of the memory at the first time of the differential pressure threshold judgment process, and 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.

 BEST MODE FOR CARRYING OUT THE INVENTION

 Hereinafter, embodiments of the blood component collection device according to the present invention will be described with reference to the accompanying drawings; FIG.

As shown in FIG. 1, a blood component collection device 10 according to the present embodiment 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 Have 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.

 [0028] 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. 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.

 [0029] 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.

 [0030] The set rotational speed of the centrifuge bowl 120 is set to about 4200 to 5800 rpm, for example. Thereby, 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). In the vicinity of the centrifuge bowl, an optical sensor (not shown) 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). )) Is provided!

 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.

[0032] 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.

 [0034] 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!

 As shown in FIG. 2, 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.

In addition, the 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, and 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.

[0038] 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.

Yes

 [0039] Some of the functions in the control unit 26 are not shown in the program recorded in the storage unit 92.

Realized by reading and executing by U.

[0040] As shown in FIG. 3, 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.

 [0041] 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.

 [0042] 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.

[0043] 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. Thus, an anticoagulant is mixed in the blood in the tube 104. A bubble sensor 34a is attached in the middle of the tube 110.

Yes

 [0045] Between the chamber 106 and the branch joint 102, a bubble sensor 34b and a clamp 36a are mounted. 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.

 [0046] 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.

 [0047] 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).

 [0048] 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).

 [0049] When blood is collected, air in the blood storage space of the centrifuge bowl 120 is transferred to and stored in the air bag 126b. In the blood return process, the air stored in the air bag 126b is returned to the blood storage space, and a predetermined blood component is returned to the donor.

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. [0051] Each of the plasma collection bag 122, the platelet collection bag 124, the intermediate bag 126a, the air bag 126b, and the bag 128 is laminated with 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.

 [0052] As 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. As such 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.

 [0054] Next, tubes that connect the components 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 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.

 [0056] 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.

[0057] 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.

 [0058] 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 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.

 [0060] The platelet collection bag 124 and the bag 128 are connected by a tube 158.

 [0061] 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.

 [0062] Next, the main procedure for collecting blood components by the blood component collecting apparatus 10 will be described with reference to FIG.

 First, predetermined initial processing is performed in step S 1 of FIG. As an initial process, 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. Thereafter, 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.

[0064] In 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.

Here, blood (blood added with an anticoagulant) is transferred through the tube 104 and introduced into the blood storage space of the rotor from the inlet of the centrifugal bowlet 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.

[0066] 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. By the rotation of the rotor, 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. In the second cycle and thereafter, the motor 64 is driven simultaneously with the blood pump 28.

 [0067] 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; L42 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 is introduced into the blood storage space, 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.

[0068] In 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. After performing this constant-speed plasma circulation process for a predetermined time, the process proceeds to step S5. [0069] In step S5, a second plasma collection step is performed. In the second plasma collecting step, plasma is collected and centrifuged in the same manner as in the first plasma collecting step. As a result, as the amount of red blood cells in the blood storage space increases, that is, as the layer thickness of the red blood cell layer increases, 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.

 [0070] In 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.

 [0071] 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 certain amount of plasma has been collected in the plasma collection bag 122, the process proceeds to step S8.

 [0072] In step S8, a platelet collecting step is performed. In the platelet collection process, 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. In this process, 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. After performing a predetermined operation in the platelet collecting process, the clamp 36e is opened, the other clamps 36a to 36d, 36f and 36g are closed, and the blood pump 28 is stopped.

 [0073] In step S9, the rotational speed of the motor 64 is controlled to decelerate and stop the rotor.

 [0074] In 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.

 [0075] 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. [0077] In the final cycle, the filtration process is started in step S5. In the filtration step, 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.

 Next, a first example of blood return processing 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. 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.

 In FIG. 7, 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.

 [0080] In FIG. 7, 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.

 First, in 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.

[0082] The following processing is performed based on the accumulated rotational speed A, for example, every A = 0.25 rotations. The donor pressure Pd is also measured every A = 0.25 revolutions. In addition to the cumulative rotational speed A, these processes performed by the control unit 26 include, for example, an accumulated blood return amount (cumulative liquid delivery amount A ′) from the start of blood return, an elapsed time since the start of blood return (elapsed blood return time). T) etc. may be used. [0083] In step S102, the blood return limiting pressure P is set to 10 to 150 mmHg. 1st fruit

 L1

 In the example, the blood return limit pressure P is set to lOOmmHg. This return limiting pressure P is

 1 1 The pressure difference between the donor pressure Pd and the initial pressure PO (hereinafter referred to as the donor pressure Pd) is too high.

 0

 In this case, 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.

[0084] Further, the inclination threshold P is set to 1050 mmHg. In the first embodiment, the inclination threshold P is set to

 twenty two

Set to 20mmHg. This slope threshold P is a stable blood return condition except immediately after the start of blood return.

 2

 Indicates the inclination that should not be changed, and indicates the allowable fluctuation range for 0.5 rotation of the blood pump 28. When this fluctuation range is exceeded, a predetermined process such as reducing the rotation speed of the blood pump 28 to reduce the donor pressure Pd is performed.

[0085] It should be noted that the inclination threshold P is an allowable fluctuation range during the predetermined rotation of the blood pump 28, and this

 2

 The predetermined value is preferably set according to the number of rollers of blood pump 28 (roller pump).

 [0086] In step S103, the blood pump 28 is rotated to start blood return. Blood pump

28 is rotated in the opposite direction to the normal direction during blood collection.

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.

[0088] In 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.

[0089] In 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).

[0090] In step S106, the first differential pressure Δ 求 め る 1 is obtained as ΔΡ1-Pd-PO. The donor pressure Pd used here is the value measured in the immediately preceding step S105. First differential pressure Δ

According to the process based on P1, the influence of the initial pressure PO can be eliminated. The first The differential pressure ΔPI is the same as the donor pressure Pd, but it is compared with the second differential pressure ΔΡ2 described later.

 0

 Indicate it in a clean way.

 In step S107, the first differential pressure Δ Ρ1 is compared with the blood return restriction pressure P, and Δ Ρ1≥Ρ

 If it is Ll L1, go to step S108, if ΔΡΚ Ρ, go to step S109

[0092] The determination in step S107 is for proactively examining the presence of signs of internal bleeding that may cause the donor to feel uncomfortable. In FIG. 7, the donor pressure Pd (that is, the first differential pressure Δ Ρ1) is returned.

 0

 If the blood pressure limit is P or more, branch processing is performed and the response processing step S108 is performed.

 1

 In this way, return of blood is interrupted and internal bleeding is prevented.

 [0093] It is possible that 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

 1

 It has been confirmed by the research of Akira. This is because the donor pressure Pd is excessively increased based on the fact that the blood return component discharged from the tip of the blood collection needle 100 is not accurately supplied to the vein.

 0

 This is considered to be because of this.

 [0094] Further, in such an initial stage, the donor pressures Pd and Pd increase rapidly to some extent.

 0

 Therefore, the threshold judgment based on the fixed blood return restriction pressure P rather than the judgment based on the rising slope value

 1

 May be.

 [0095] In FIG. 7, graphs 510 and 512 reach higher than the blood return limiting pressure P.

 L1

 Therefore, 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. On the other hand, the graphs 522 524 and 526 are not limited by the blood return limiting pressure P.

 L1

[0096] As shown in FIG. 6, in this response process, 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.

 [0098] Processing power up to step S10;! To S109 For convenience, it can be classified as differential pressure threshold determination processing, and in FIG. 7, the region on the left side of A = 2.5 corresponds. In addition, the following processing can be classified as pressure value inclination judgment processing for convenience. In FIG. 7, the area on the right side of A = 2.5 corresponds.

 [0099] In 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.

 [0100] In 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.

 [0101] In step S112, the second differential pressure Δ Ρ2 is obtained as A P2-Pd-Pd. here

 N N- 2

 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.

 N- 2

 One pressure Pd.

 [0102] Thus, by obtaining the second differential pressure ΔΡ2 at a predetermined interval, it is possible to reduce the influence of noise and the like. This second differential pressure Δ Ρ2 indicates the slope of the donor pressures Pd and Pd

 0

 It will be.

 [0103] In step S113, it is checked whether or not the second differential pressure ΔΡ2, 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

 L2

 The pressure Δ Ρ2 is compared with the slope threshold P, and when Δ Ρ2≥Ρ, the process proceeds to step SI 14,

 L2 L2

 If Δ Ρ2 <Ρ, proceed to step S I 14.

 L2

[0104] The determination in step S113 is a proactive test for the presence of signs of internal bleeding that may cause the donor to feel uncomfortable. In Fig. 7, if the second differential pressure ΔΡ2 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.

 [0105] Returning to a steady state (for example, the cumulative rotation speed A is 2.5 or later) may give the donor a sense of discomfort. Width

 2

 It is confirmed by the inventor's research that this is a large time. This is because the donor pressure Pd begins to rise based on the fact that the blood collection needle 100, which was initially properly punctured, is displaced for some reason and the blood return component is no longer being accurately supplied to the vein.

 0

 It is exempted.

 In FIG. 7, in graph 526, the range of fluctuation per 0.5 rotation is larger than the slope threshold value P in the region where the cumulative rotational speed A is about 12 times or more.

 2

 First, 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. On the other hand, the graphs 522 and 524 are not limited by the slope threshold P.

 [0107] As is clear from Fig. 7, the graph 526 is improved by performing the processing using the slope threshold value P.

 2

 As soon as it begins to rise, it is possible to make a quick decision.

 1

 Detection is possible in a shorter time than reaching the donor pressure Pd force OOmmHg.

 0

 [0108] The handling process in step S114 is the same process as in step S108.

[0109] In 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.

 [0110] Next, a method for obtaining the first differential pressure Δ 第 1 and the second differential pressure ΔΡ2 by recording the donor pressure Pd in the memory 600 of FIGS. 8A to 9B will be described. 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.

 [0111] In FIGS. 8A to 9B, the symbol shown at each address adO adlO is the donor pressure Pd, of which P0 is the initial pressure. PN (N = 1, 2, 3, ···) indicates the donor pressure Pd obtained for the Nth time.

[0112] First, 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.

[0113] The donor pressure Pd = Pl obtained at the first time is recorded at the address adO as shown in FIG. 8B. The first differential pressure Δ Ρ1 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 Δ Ρ1—PI—P0. . For example, 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. The address pointer I takes a value between 0 and 0. When I = 11, it is set to 1-0.

[0114] In FIG. 8B and subsequent figures, hatched addresses indicate a portion referred to for obtaining the first differential pressure Δ 差 1 or the second differential pressure ΔΡ2.

[0115] 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 Δ Ρ1 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 Δ Ρ1—P2—P0.

Yes

 Thereafter, similarly, the donor pressure Pd is sequentially recorded in ascending addresses, and the first differential pressure Δ Ρ1 is obtained by subtracting the value of the next address (that is, P0).

 Next, as shown in FIG. 9A, 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 Δ Ρ2 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 Δ Ρ2—Ρ11—P9 .

 [0118] For example, when 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, and 1−2 The address value indicated by is P9. Of course, the address pointer operation is not limited to this.

 [0119] 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 Δ Ρ2 at this time is Δ Ρ2-P12-P10, and is obtained by the address pointer operation described above.

[0120] Thereafter, 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 Δ Ρ2 is obtained by subtracting the value of the two adjacent addresses.

[0121] As described above, according to the blood component collection device 10 according to the present embodiment, when the blood pump 28 is rotated at the time of blood return! (2) By slowing or stopping the blood pump 28 when the differential pressure ΔP2 exceeds the predetermined inclination threshold P

 2

 It is possible to predict and prevent the occurrence of internal bleeding that may cause discomfort to the donor.

[0122] Of course, 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 accumulative liquid supply A ′ and the accumulative rotational speed A can be converted into each other by the relational expression A / A ′ = l. Further, 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).

In the above description, the first differential pressure Δ 処理 1 is compared with the fixed blood return restriction pressure Α in the differential pressure threshold judgment process until the cumulative rotational speed A reaches Α = 2.5. Judgment power

 1

 It can also be said that the product rotation speed Α is Α = 2.5.

That is, the first differential pressure Δ Ρ1 is the difference between the donor pressure Pd at the time of the cumulative rotational speed Α and the initial pressure Ρ0, and its slope is Δ Ρ1 / Α. The blood return limiting pressure P to be compared at that time is expressed as P / A as the slope threshold. In addition, Δ Ρ1 in step S107 described above

1 1

 ≥P can be expressed as Δ Ρ1 / Α≥Ρ / Α.

 This is a tilt comparison determination similar to S113, and can be said to be a kind of pressure value tilt determination processing.

Next, 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. In the second embodiment, basically the same processing as in the first embodiment is performed. In the first embodiment, the blood return limit pressure P is initially set, and thereafter, the inclined region P is set.

 1

 However, in the second embodiment, the slope region P is initially set and then the slope is set.

twenty three

 The diagonal area P is set.

 Four

[0126] 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. [0127] In step S302, the inclined region P and the inclined region P are set. The slope threshold P is

 3 4 3

Set the permissible fluctuation during the 0.25 rotation of the blood pump 28 during the period A <2.5, for example, 10 50 mmHg. In the second example, the inclination threshold P is set to 20 mmHg.

 Three

 To do. Figure 7 shows the tilt threshold P as 20mmHg / 0.5 rotation.

 Three

 [0128] Inclination threshold P varies during 0.5 rotation of blood pump 28 in the period Α≥2.5

 Four

 The allowable width is the same parameter as the slope region 傾斜 described above. The inclined region Ρ is, for example,

 twenty two

 10 Set to 50mmHg. In the second embodiment, the inclination threshold P is the same as the inclination area P. 20

 4 Set to 2 mmHg. Figure 7 shows the slope threshold P.

 L4

 Step S306 is a process for obtaining the differential pressure ΔPI during the period of Α <2.5, and the same process as in step S112 is performed.

[0130] Step S307 is the same processing as step S107 described above, and is a blood return limiting pressure P.

 Compare with differential pressure Δ Ρ1 using slope threshold P instead of L1.

 Three

 [0131] Step S313 is the same processing as step S113 described above.

 2 Compared with the differential pressure Δ Ρ2 using the inclination threshold P instead.

 Four

 [0132] According to the second embodiment, the same effects as those of the first embodiment can be obtained.

[0133] Note that the inclination threshold P changes during the 0.5 rotation of the blood pump 28, as does the inclination threshold P.

 3 4

 In this case, it can be set by the allowable movement range. For example, set to 20 to;! OOmmHg.

Next, 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.

 First, in 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.

In step S402, the blood return limit pressure P1 is set to 170 240 mmHg. In the third example, 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. In other words, 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.

 In 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.

 [0138] 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. In addition, 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.

 [0139] 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 (see Fig. 14).

[0140] In 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.

[0141] In step S405, the donor pressure Pd at that time is examined to obtain a differential pressure ΔP from the donor pressure Pd at the start of blood return.

[0142] In step S406, the differential pressure Δ 確認 is confirmed. If ΔΡ ≥ lOOmmHg, the process proceeds to step S407, and if A P <100 mmHg, the process proceeds to step S411.

[0143] 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. In FIG. 14, when the donor pressure Pd is equal to or higher than the point P11, or the donor pressure When the slope of Pd is greater than or equal to the slope of points P11 to P12, branch processing is performed and blood return is interrupted by the following steps S407 to S409 to prevent internal bleeding.

[0144] It has been confirmed by the present inventor's study that in FIG. 14, there is a possibility that the donor may feel uncomfortable in a range above the threshold line 501 (the threshold value for stopping). Therefore, 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).

[0145] Pd = 27 XA + 14 (mmHg)

 Pd = 31 XA '+ 14 (mmHg)---(2)

 Here, A ′ is the cumulative amount of liquid delivered by the blood pump 28 (mU).

 [0146] In FIG. 14, it is determined that the graphs 510 and 512 are above the threshold line 501 and that there is a possibility that internal bleeding that may cause a sense of incongruity to the donor may occur. The process of S407 is performed.

 In FIGS. 14 and 15, 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.

 [0148] Of these, 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.

 In FIG. 14 and FIG. 15, 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.

 [0150] In 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. After this, if it is determined in step S410 that the operator can resume blood return, 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.

 [0151] On the other hand, in step S411, it is confirmed that the cumulative rotation speed A has reached 10 rotations, and the flow proceeds to step S412.

[0152] In step S412, the donor pressure Pd is confirmed. When Pd> lOOmmHg, the process proceeds to step S413, and when Pd≤1 OOmmHg, the process proceeds to step S416 (FIG. 14). Point P22).

 [0153] 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.

 [0154] Therefore, 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).

 [0155] Pd = 6 XA + 32 (mmHg)…)

 Pd = 7 XA '+ 32 (mmHg) (4)

 As described above, A ′ is the cumulative amount of liquid fed by the blood pump 28 (mU).

[0156] As is clear from the equations (3) and (4), 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.

[0157] The threshold lines 501 and 502 are not necessarily fixed and may be changed empirically.

Or a curve. Further, it may be changed according to the weight, sex, donor blood flow rate in the puncture site, and the like.

 [0158] Here, 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. In the case of a simple waveform, it has been confirmed by the inventor's research that 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.

 [0159] In the second case where the internal bleeding that the donor does not feel uncomfortable may occur, the study of the present inventor confirmed that the donor pressure Pd shows a change in the chevron in FIG. This is considered to be a sign of a shift to internal bleeding for the same reason as in the first case. Such a second case is cut halfway by the following steps S413S to S414.

That is, in 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.

 [0161] In 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.

 [0162] The determination in step S414 is determined by the fact that the supplied differential value has switched from a positive value to a negative value. In addition, according to the research of the present inventor, it has been confirmed that there is an indication of internal bleeding particularly in the case of a convex convex chevron that is sharp upward. In order to determine such a sharp convex chevron, as shown in FIG. 16, 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. Alternatively, 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.

 Of course, the differential value 550, the second-order differential value 552, and other waveforms may be determined after removing noise components by predetermined filtering.

 [0164] In FIG. 14, 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.

 [0165] Fig. 14 こ ヽ ((Graphs 516, 518 and 520 こ つ (((Because it is above the straight line, line 502, internal bleeding that does not give the donor a sense of incongruity can occur) Therefore, the process of step S415 below is performed.

 On the other hand, since the graphs 522 and 524 are below the threshold line 502, it is determined that there is no possibility of internal bleeding, and the restriction process is not performed.

In FIGS. 14 and 15, in graphs 522 and 524, the force that shows a tendency that donor pressure Pd temporarily decreases in the range of the cumulative rotational speed repulsive force S10-20. The plasma that was present in the middle of the blood flowed in the direction of the donor, mixed with red blood cells in the air trap chamber, and the hematocrit value of the blood coming out of the chamber 106 decreased. This is because a temporary drop in passage resistance occurs when the blood passes through the blood collection needle 100. [0168] In step S415, the blood return limit pressure PI in step S402 is set to +120 to +17 OmmHg. In the present embodiment, 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.

 [0169] In the process of 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. The ability to prevent the occurrence of internal bleeding as a result, and the ability to control talents.

 [0170] As a means for preventing / suppressing internal bleeding, 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.

 In step S416, the flag F is confirmed. If F = 1, the process proceeds to step S417, and if F = 0, the process proceeds to step S418.

 [0172] In 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.

 [0173] In FIG. 14, 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.

 In 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.

 [0175] 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.

[0176] In 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.

[0177] In 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.

[0178] In 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

If it is less than / min, go to step S422.

[0179] 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.

Adjust P1 appropriately to prevent internal bleeding.

[0180] In other words, if the average rate of blood return is reduced in this way, this is the third case in which the donor may not feel uncomfortable with internal bleeding, which is caused by swelling around the puncture site due to internal bleeding. Because of this, it is judged that there is a possibility that the blood collection speed may not be increased in the blood collection process of the next cycle, and prescribed precautions are taken.

[0181] On the other hand, if the average rate of blood return has not decreased, it is determined that there is a low possibility of internal bleeding that the donor does not feel uncomfortable!

[0182] When the blood return rate setting value is 50 mL / min or less, it is natural that the average blood return rate also decreases, and therefore step S421 is bypassed by the branch determination in step S419.

 [0183] In 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.

[0184] In step S423, the blood return restriction pressure P1 is returned to 200 mmHg, and flag F is set.

Set to 0.

 [0185] It should be noted that 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.

[0186] In 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.

 [0187] On the other hand, in step S426, the cumulative rotational speed A is obtained, and in step S427,

Check if A≥35. If A≥35, proceed to step S428 and A <

If 35, return to step S426 and wait.

[0188] In 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.

[0189] 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.

 [0190] 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.

 [0191] That is, (2) 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. (3) Set value in the range of donor pressure Pd from +100 to +200 mmHg from the start of return of blood, for example, time force to reach +150 mmHg, set value in the range of ¾ to 20 sec, for example, 34 sec or more . (4) Elapsed time from the start of blood return to a set value in the range of 20 to 20 seconds, for example, 34 seconds, donor pressure Pd is set to a set value in the range of +100 to +200 mmHg, for example, +150 mmHg Reach V, what! / (5) Set value in the range of donor pressure Pd from +100 to +200 mmHg from the start of return of blood, for example, cumulative rotational speed A until reaching +150 mmHg A is smaller than the predetermined value (20 to 60) For example, A> 35.

In other words, 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.

[0193] 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.

[0194] When these conditions are satisfied, it can be determined that internal bleeding does not occur, and recovery processing can be performed in the following step S429! /.

[0195] In step S429, the blood return restriction pressure P1 is returned to 200 mmHg, and the flag F is set.

Set 0, then go to step S416. In addition, when the restriction is based on the speed rather than the pressure, the blood return speed setting value reduced to 60 mL / min may be returned to the original 90 mL / min.

 [0196] For example, the above condition (5) can be determined based on the point P3 in FIG. When making a determination based on the condition (5), the graph 520 initially shows a mountain-shaped waveform, and when Pd <+150 mmHg when the blood return limiting pressure P1 is a force A = 35, which is limited to 150 mmHg. For some reason, it can be determined that internal bleeding does not occur, and the blood return limiting pressure P1 can be returned to 200 mmHg in step S429. On the other hand, in graph 518, the blood return limiting pressure P1 is initially limited to 150 mmHg exceeding the threshold line 502, and when A = 35, Pd = +150 mmHg, which is just passing on the boundary, The possibility of internal bleeding cannot be ruled out when returning to the original situation, and the return pressure limit P1 is limited to 150 mmHg.

[0197] Next, a procedure for controlling the rotational speed N of the blood pump 28 during blood collection and blood return will be described. 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.

 [0198] First, at the start of blood collection, a set value force of 0 + 150 mL / min is started.

 [0199] At the time of blood collection, when the donor pressure Pd is not less than the set value of + 220 + 300 mmHg, or

 When it is less than the set value of 300 100111111 ^ ¾, 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.

[0200] When the donor pressure Pd is greater than the set value of -50 + 30 mmHg and less than the set value of +20 + 300 mmHg, the acceleration of the set value of +2 + 90 mL / min / sec Accelerates within the range up to the set speed.

[0201] 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.

[0202] When the donor pressure Pd is over the set value of -200 50mmHg and less than the set value of 150mmHg, the deceleration will be within the range up to the flow rate of 0 with a deceleration of 5mL / min / sec. Do.

[0203] When the donor pressure Pd is greater than the set value of -280 80mmHg and less than the set value of -200 50111111 ^ ¾, the flow rate is 0 with a deceleration of -100 10111/111 ^ / 36 ₍ set value) Decelerate within the range up to.

[0204] These setting values are set so as not to overlap (inconsistent) with each other.

[0205] Next, when returning blood, 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.

[0206] When the donor pressure Pd is less than the set value of -300 lOOmmHg, it is determined that the pressure is abnormal, and the rotation of the blood pump 28 is stopped to perform a predetermined countermeasure process.

[0207] Next, the case where blood return limiting pressure P1 is set to 200 mmHg in the initial state at the time of blood return will be described. In this case, when 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.

[0208] Donor pressure? (If 1 is greater than the set value of +155 + 300111111 ^ ¾ and less than the set value of +220 + 300mmHg, it will decelerate at the set speed of −100 10111 and / 111 ^ / 36 ₍ set value).

 [0209] When the donor pressure Pd is in the range above the set value of +120 + 250 mmHg and below the set value of +155 + 260 mmHg, 2 Deceleration is performed with a deceleration of the set value of 2 100 mL / min / sec.

[0210] When the donor pressure Pd is in the range above the set value of +20 + 200 mmHg and below the set value of +150 + 250 mmHg, the hysteresis process is performed and the deceleration is first in progress. Check the force, the force in the middle of acceleration.

[0211] When deceleration is in progress, continue deceleration at a deceleration of 2 100 mL / min / sec. When acceleration is in progress, continue acceleration within the range up to the set speed with the acceleration of + 2 + 90mL / min / sec.

[0212] When the donor pressure Pd is over the set value of -220 50 mmHg and less than the set value of +20 + 200 mmHg, within the range up to the set speed with the acceleration of the set value of +2 + 90 mL / min / sec Accelerate.

[0213] These setting values are set so as not to overlap (conflict) with each other.

[0214] By such processing, appropriate speed control is performed both during blood collection and during blood return.

[0215] In the above description, the one-arm collection method in which blood is returned after blood collection is taken as an example. However, 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. In the case of the both-arm sampling method, a blood collection pressure sensor and a blood return pressure sensor, and a suction pump and a discharge pump may be provided independently.

[0216] Next, the case where blood return restriction pressure P1 is set to 150 mmHg at the time of blood return will be described.

 [0217] In this case, the donor pressure Pd is more than the set value of +100 + 200mmHg, +200 +30

When the range is less than the set value of OmmHg, -100 10111 and / 111 ^ / 36. Decelerate at the deceleration of the set value.

[0218] When the donor pressure Pd is in the range above the set value of +90 + 220 mmHg and below the set value of +100 + 200 mmHg, it is decelerated at a deceleration of 2 100 mL / min / sec.

 [0219] When the donor pressure Pd is in the range above the set value of +20 + 150 mmHg and below the set value of +90 + 220 mmHg, hysteresis processing is performed, and at first, deceleration or acceleration is in progress Power.

[0220] When deceleration is in progress, continue deceleration at the set deceleration of 2 100 mL / min / sec. When acceleration is in progress, continue acceleration within the range up to the set speed with the acceleration of + 2 + 90mL / min / sec. In other cases, the control may be performed in the same manner as when the blood return limiting pressure P1 is set to 200 mmHg. [0221] Note that these setting values are set so as not to overlap (inconsistent) with each other.

[0222] Also, in the case of! / At the time of blood collection and return, or in the case of deviation! /, As a result of performing the above pump control, the rotational speed N of the blood pump 28 becomes 0, and the state is When a predetermined time (for example, 3 to 60 seconds) has elapsed or when a predetermined time (for example, 3 to 180 seconds) has been accumulated, the operator is notified (error screen display, alarm sound, or lamp is lit) to prompt the predetermined processing. Good. In this case, when the operator performs a treatment such as correcting the puncture state and performs a predetermined restart instruction operation, the blood component collection device 10 restarts and continues the process. When the rotation speed N is 0, a predetermined notification sound indicating a decrease in the flow rate may be sounded.

[0223] Of course, the control procedure of the blood pump 28 based on the return limiting pressure P1 is not limited to this.

 [0224] Of course, the cumulative rotational speed A in each of the above descriptions may be replaced with, for example, the cumulative liquid feeding amount A '.

Claims

The scope of the claims

 [1] In a blood component collection device (10) that separates blood collected from a donor and then returns a predetermined blood component to the donor.

 A return line (104) for returning the remaining blood components to the donor;

 A variable speed blood pump (28) for delivering blood components to the blood return line (104), a pressure sensor (38) for detecting the pressure (Pd) of the blood return line (104),

 A controller (26) for driving the blood pump (28);

 Have

 The control unit (26) determines the pressure (Pd) or blood return speed (V) of the blood return line (104) according to one or more conditions based on the pressure (Pd) obtained from the pressure sensor (38). A blood component collection device (10), characterized by setting a limit of the number of times.

[2] In the blood component collection device (10) according to claim 1,

 One of the conditions is that when the blood pump (28) is rotated and blood return is started, the pressure (Pd) is equal to the cumulative rotational speed of the blood pump (28), the cumulative liquid supply amount, or the blood return history. A blood component collection device (10), characterized in that the condition is that a restriction threshold (502) set in accordance with time is exceeded.

[3] In the blood component collection device (10) according to claim 2,

 When the control unit (26) rotates the blood pump (28) from the start of blood return! /, The pressure (Pd) is changed to the cumulative rotational speed and cumulative feed of the blood pump (28). When the stop threshold (501) larger than the limit threshold (502) set corresponding to the liquid volume or the return time is exceeded, or when the slope of the pressure (Pd) exceeds a predetermined slope The blood component collection device (10), wherein the blood pump (28) is decelerated or stopped.

[4] The blood component collection device (10) according to any one of claims 1 to 3,

 One of the conditions is a blood component collection device (10) characterized by showing a change in a mountain shape that descends after the pressure (Pd) rises.

[5] The blood component collecting device (10) according to any one of claims 1 to 4,

The control unit (26) has a speed detection unit (98) for detecting the blood return speed (V) of the blood return line (104), One of the conditions is a blood component collection device (10) characterized in that the blood return speed (V) is a predetermined flow rate threshold value or less.

 [6] In the blood component collection device (10) according to any one of claims 1 to 5,

 The controller (26) reduces the limit value of the pressure (Pd) or the blood return speed (V) of the blood return line (104) according to the condition, and then the cumulative rotation of the blood pump (28). The pressure (Pd) falls below a predetermined recovery judgment pressure threshold, or the blood return speed (V) exceeds a predetermined recovery judgment flow rate threshold, depending on the number, accumulated liquid delivery amount or elapsed time. The blood component collecting device (10), characterized by increasing a limit value of the pressure (Pd) or the blood return speed (V) of the blood return line (104).

 [7] After separating blood collected from the donor, a blood return line (104) that returns the blood component to the donor.

 A variable speed blood pump (28) for delivering blood components to the blood return line (104), a pressure sensor (38) for detecting the pressure (Pd) of the blood return line (104),

 A controller (26) for driving the blood pump (28);

 Have

 When the control unit (26) starts returning blood by rotating the blood pump (28), the pressure (Pd) obtained from the pressure sensor (38) is accumulated in the blood pump (28). When the limit threshold (502) or the stop threshold (501) set corresponding to the rotation speed, accumulated liquid supply amount, or elapsed time of blood return is exceeded, or the slope of the pressure (Pd) is a predetermined slope (P ), The blood component collection device (10) is characterized by performing a pressure judgment process for decelerating or stopping the blood pump (28).

[8] The blood component collection device (10) according to claim 7,

 The control unit (26) starts the pressure determination process after a predetermined time has elapsed from the start of blood return or after the blood pump (28) has rotated by a predetermined number. Collection device (10).

[9] In the blood component collection device (10) according to claim 7 or 8,

The control unit (26) sets the pressure (Pd) at the start of blood return to an initial pressure (P0), and until a predetermined time has elapsed from the start of blood return or the blood pump (28) is a predetermined number. Rotate Until the differential pressure between the pressure (Pd) obtained from the pressure sensor (38) and the initial pressure (PO) exceeds a predetermined threshold, the differential pressure for decelerating or stopping the blood pump (28). A blood component collection device (10) characterized by performing a determination process.

 In a blood component collection device (10) that separates blood collected from a donor, collects a predetermined blood component, and returns the remaining blood component to the donor.

 A return line (104) for returning the remaining blood components to the donor;

 A variable speed blood pump (28) for delivering blood components to the blood return line (104), a pressure sensor (38) for detecting the pressure (Pd) of the blood return line (104),

 A controller (26) for driving the blood pump (28);

 Have

 The control unit (26) sets the pressure (Pd) at the start of blood return to an initial pressure (P0), and until a predetermined time has elapsed from the start of blood return or the blood pump (28) is a predetermined number. Before the rotation, when the pressure difference between the pressure (Pd) obtained from the pressure sensor (38) and the initial pressure (P0) exceeds a predetermined threshold value, the blood pump (28) is decelerated or stopped. A blood component collection device (10) characterized by performing a differential pressure determination process.