JP4979709B2 - Blood component collection device - Google Patents

Description

  The present invention relates to a blood component collection apparatus that collects blood from a donor, separates the collected blood into a plurality of components, collects predetermined components, and returns the remaining components to the donor.

  Blood collection includes whole blood collection in which blood is collected as it is and component blood collection in which only predetermined components are extracted. 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.

  In the blood component collection device, after the needle is punctured to the donor, blood collection processing performed through the needle, the collected blood is separated into a plurality of components, a predetermined component is collected, and the remaining components are The process of returning blood 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 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.

  In order to reduce the time to restrain the donor in a series of component blood collections, it is desirable to perform blood collection and return as quickly as possible. To that end, it is sufficient to increase the rotational speed of the pump, but to increase the rotational speed. Of course there are limits.

  From this point of view, Japanese Patent Publication No. 6-57250 (Japan) (WO86 / 00231A1) generates a vein resistance and a pressure / flow rate curve based on the resistance by performing tests in two flow ranges for each donor. However, an apparatus for defining the rotational speed of the pump by this pressure / flow rate curve has been proposed.

  However, depending on the puncture state of the needle, at the time of returning blood, the blood component stays in a compressed state, and the pressure in that portion rises and acts to push back the needle. As a result, the needle tip comes out of the vein, blood is pumped out of the blood vessel, and internal bleeding occurs. Further, even if the needle tip does not come out of the vein, the same state occurs when blood leaks from the gap between the needle and the blood vessel wall.

  In addition to the pain being noticed by the donor, the donor may feel a little uncomfortable, or the donor or operator may have noticed that the puncture site is swollen. There may be no. When such internal bleeding occurs, the skin may be swollen or discolored in appearance, and it may take a certain amount of time to recover, and may cause discomfort or anxiety to the donor.

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

  In addition, even if the donor does not feel uncomfortable during the blood return, sufficient blood collection speed cannot be obtained during blood collection in the next cycle, and blood collection / return is stopped before the required amount of blood components is obtained. There are cases where it is necessary to do so.

  By the way, when returning blood, even if internal bleeding occurs, the donor may not be immediately aware, and it is not possible to take an appropriate action immediately, and the internal bleeding becomes visible to the donor. May cause discomfort or anxiety.

  In addition, there is no means for predicting or preventing the occurrence of internal bleeding that does not feel uncomfortable for the donor.

  The present invention has been made in view of such problems, and an object of the present invention is to provide a blood component collection device that can prevent internal bleeding in advance or moderately suppress the occurrence of internal bleeding in the blood return process. .

The blood component collection device according to the present invention is a blood component collection device that separates blood collected from a donor and then returns a predetermined blood component to the donor. A blood return line that returns the remaining blood components to the donor; A variable speed blood pump for delivering blood components to the blood return line, a pressure sensor for detecting the pressure of the blood return line, and a control unit for driving the blood pump, wherein the control unit comprises the pressure set the limit value of the pressure or blood return rate of the blood return line in response to conditions rather based on the pressure obtained from the sensor, the conditions, when you start the blood return by rotating the blood pump The condition is that the pressure exceeds a limiting threshold set for each stage divided according to the cumulative number of rotations of the blood pump, the cumulative liquid supply amount, or the elapsed time of blood return .

  According to such a condition, it is possible to predict the occurrence of internal bleeding that the donor does not notice, and by reducing the pressure of the blood return line or the limit value of the blood return speed, the occurrence of internal hemorrhage that may give the donor a sense of incongruity. Can be predicted, prevented, or moderately suppressed.

  In addition, when the blood pump is rotated from the start of blood return, the control unit sets the pressure corresponding to the cumulative rotational speed of the blood pump, the cumulative liquid supply amount, or the blood return elapsed time. The blood pump may be decelerated or stopped when a stop threshold value greater than the limit threshold value is exceeded or when the pressure gradient exceeds a predetermined gradient. As a result, it is possible to predict and prevent the occurrence of internal hemorrhage that can give a sense of incongruity to the donor.

Furthermore, the conditions may further comprise a condition that shows a chevron change the descending after the pressure rose.

Wherein the control unit includes a speed detector for detecting a blood return rate of said blood return line, wherein the conditions further, the blood return rate may include a condition that less than a predetermined flow rate threshold.

  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 the pressure according to the cumulative rotation speed, the cumulative liquid supply amount, or the elapsed time of the blood pump. Is lower than a predetermined recovery judgment pressure threshold, or when the blood return rate exceeds a predetermined recovery judgment flow rate threshold, the pressure of the blood return line or the limit value of the blood return speed may be increased. . According to such conditions, even if the pressure or speed is limited before that, it can be confirmed that internal bleeding does not occur from the subsequent situation, the pressure or speed limit is relaxed or restored, Rapid blood return is achieved.

It is a perspective view which shows the blood component collection device which concerns on this Embodiment. 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 1st Example of a blood return process. It is a flowchart of a response process. It is a graph which shows the change of the donor pressure in the blood return process, and the blood return speed. 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 shows the contents of the memory when the cumulative rotation speed is 0.25 in the pressure value inclination determination process. FIG. 8C is a diagram showing the contents of the memory when the cumulative rotational speed is 0.5 in the pressure value inclination determination process, and FIG. 8D is the cumulative rotational speed of 2 in the pressure value inclination determination process. FIG. 8E is a diagram illustrating the contents of the memory when the accumulated rotation speed is 2.5 in the pressure value inclination determination process. FIG. 9A is a diagram illustrating the contents of the memory at the first time of the differential pressure threshold value determination process, and FIG. 9B is a diagram illustrating the contents of the memory when the cumulative rotation speed is 3.0 in the differential pressure threshold value determination process. It is a flowchart of 2nd Example of a blood return process. It is a flowchart (the 1) of 3rd Example of a blood return process. It is a flowchart (the 2) of 3rd Example of a blood return process. It is a flowchart (the 3) of 3rd Example of a blood return process. It is a graph which shows the change of the initial donor pressure of the 3rd Example of a blood return process, and the blood return rate. It is a graph which shows the change of the donor pressure of the whole period of the 3rd Example of a blood return process, and the blood return rate. It is a graph which shows the differential value and 2nd-order differential value of donor pressure.

  Hereinafter, an embodiment 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 main body 15 includes a left control mechanism 22 and a right centrifugal mechanism (separation means) 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 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 centrifuge mechanism 24 is a mechanism that is equipped with a centrifuge bowl (centrifuge) 120 of the blood collection kit 14 and centrifuges the blood introduced into the centrifuge bowl 120.

  The set rotation speed of the centrifuge bowl 120 is set to, for example, about 4200 to 5800 rpm. 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.

  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 blood pump 28 functions as a suction pump that draws blood by rotating in a predetermined forward direction when blood is collected, and functions as a discharge pump that sends blood components to the tube 104 by rotating in the reverse direction when returning blood.

  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 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, 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 into which a part of the blood collection path system (blood collection circuit) 14a (see FIG. 3) in the blood collection kit 14 is inserted, and measures the donor pressure Pd indicating the pressure of the blood collection line. Acts as a sensor 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 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 control unit 26 has 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 and a monitor interface 86 that performs input and output of the monitor 20. Further, the control unit 26 cooperates with each function unit based on a mode control unit 88 for controlling a component blood collection processing operation including initial processing, blood collection, separation collection, and blood return processing, input signals of each sensor, and the like. Based on an abnormality monitoring unit 90 that monitors an abnormality, a storage unit 92 that stores a predetermined program and data, a timer 94, a communication unit 96 that performs data communication with an external device, and the rotation speed of the blood pump 28. And a speed detection unit 98 for obtaining the blood collection speed and the blood return speed V.

  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 88b include a function of controlling the rotation speed N of the blood pump 28 based on the donor pressure Pd.

  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. 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.

  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 tube 104 (and a tube 140 described later) is commonly used for blood collection and blood return, and acts as a blood collection line and a blood return line.

  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. 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 is connected to the tube 110 and the branch joint 116. Thus, an anticoagulant is mixed in the blood in the tube 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 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 collected platelets (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, the air in the blood storage space of the centrifuge bowl 120 is transferred 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 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 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 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 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 bacteria-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 is composed of a bacteria-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. 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. The blood collection kit 14 is provided with a cassette housing 42 in which tubes are concentrated and a filter cassette 170 (see FIG. 1) for holding a part of the tubes and the filter 160.

  Next, main procedures 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 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. The first plasma collection step is a step of collecting plasma obtained by introducing blood into the blood storage space of the centrifugal 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 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 of the centrifuge bowl 120 is started in a state where a predetermined amount of blood is 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.

  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 is introduced into the blood storage space, the plasma flows out from the outlet of the centrifuge bowl 120. Therefore, this timing is detected by the bubble sensor 34d, and the clamping operation is performed. The plasma is switched to be introduced into and collected from the plasma collection bag 122 via 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 a blood storage space. 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 from the plasma collection bag 122 through the tubes 164, 168 and 140, and plasma flowing out from the discharge port of the centrifuge bowl 120 enters 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.

  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. As a result, 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, and therefore, based on the detection signal from the optical sensor 62. After confirming that the interface has reached a predetermined level, 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. 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 at the first acceleration, and then changed to a second acceleration larger than the first acceleration. And circulate while accelerating the blood, allowing platelets to flow out of the blood storage space, and collecting (reserving) 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.

  In step S10, the blood return process is started. The blood return step is a step of returning blood components (mainly red blood cells and white blood cells) remaining in the blood storage space of the rotor to the donor. That is, the clamp 36a and the clamp 36e are opened, and the blood pump 28 is reversed. As a result, blood components remaining in the blood storage space of the rotor are discharged from the inlet 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.

  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, a first example of blood return processing performed in step S10 (see FIG. 4) will be described with reference to FIGS. The following processing is performed each time for blood return processing that is performed a plurality of 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 inclination determination process (pressure determination process) performed thereafter.

  In FIG. 7, 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 a graph 526 indicated by the thick line is not changed as it is. Although it does not give a great sense of incongruity to the donor, it is judged that internal bleeding may occur due to the blood collection needle 100 being removed from the donor's blood vessel. The graphs 522 and 524 indicated by thin lines show the internal bleeding This is the case when it is determined that there is no possibility.

  In FIG. 7, vertical axes 530, 532, and 534 are lines that representatively indicate locations where 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 speed at the time of blood collection is defined as a positive value, the blood return speed V is expressed as a negative value.

  First, in step S101 in FIG. 5, measurement of the cumulative rotation 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.

  The following processing is performed based on the cumulative rotational speed A, for example, every A = 0.25 revolutions. The donor pressure Pd is also measured every A = 0.25 revolutions. In addition to the cumulative rotation speed A, these processes performed by the control unit 26 include, for example, an integrated blood return amount (cumulative liquid supply amount A ′) from the start of blood return, an elapsed time from the start of blood return (elapsed blood return time T ) Or the like.

In step S102, the blood return limit pressure P _L1 is set to ₁₀ to 150 mmHg. In the first embodiment, the blood return limit pressure P _L1 is set to 100 mmHg. This blood return limiting pressure P _L1 is the rotational speed of the blood pump 28 in order to lower the donor pressure Pd when the pressure difference between the obtained donor pressure Pd and the initial pressure P0 (hereinafter referred to as donor pressure Pd ₀ ) is exceeded. It is a pressure value that serves as a reference for performing a predetermined process such as reducing (the number of revolutions per hour).

Further, the inclination threshold value P _L2 is set to 10 to 50 mmHg. In the first embodiment, the inclination threshold value P _L2 is set to 20 mmHg. This inclination threshold value P _L2 indicates an inclination that cannot be changed in a stable blood return state except immediately after the start of blood return, and indicates an allowable fluctuation range during 0.5 rotation of the blood pump 28. When the fluctuation range is exceeded, a predetermined process such as reducing the rotation speed of the blood pump 28 is performed to lower the donor pressure Pd.

The inclination threshold value P _L2 is an allowable fluctuation range during a predetermined rotation of the blood pump 28, and this predetermined value is preferably set according to the number of rollers of the blood pump 28 (roller pump).

  In step S103, 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.

  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 so as to perform acceleration until reaching the blood return rate set value of 90 mL / min.

  In step S104, 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 has made 0.25 revolutions. Check whether or not. When the rotation is 0.25, the process proceeds to step S105. When the rotation is less than 0.25, the process waits.

  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. A method of using this ring buffer will be described later (see FIGS. 8A to 9B).

In step S106, the first differential pressure ΔP1 is obtained as ΔP1 ← Pd−P0. The donor pressure Pd used here is the value measured in the immediately preceding step S105. According to the process based on the first differential pressure ΔP1, it is possible to eliminate the influence of the initial pressure P0. The first differential pressure ΔP1 is the same value as the donor pressure Pd _0, specified as easily compared with the second pressure difference ΔP2, which will be described later.

In step S107, the first differential pressure ΔP1 is compared with the blood return restriction pressure P _L1, and if ΔP1 ≧ P _L1 , the process proceeds to step S108, and if ΔP1 <P _L1 , the process proceeds to step S109.

The determination in step S107 is for probabilistic examination of the presence of signs of internal bleeding that may cause the donor to feel uncomfortable. In FIG. 7, the donor pressure Pd ₀ (that is, the first differential pressure ΔP1) If it is equal to or greater than _L1 , a branch process is performed, and blood return is interrupted in step S108 of the corresponding process to prevent internal bleeding.

There is a possibility that the donor may feel uncomfortable in the initial stage (for example, the period when the cumulative rotation speed A is up to 2.5) in the range above the blood return limiting pressure P _L1 in FIG. This has been confirmed by the inventors' research. This is considered to be because the donor pressure Pd ₀ 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.

Further, in such an initial stage, the donor pressures Pd and Pd ₀ increase sharply to some extent. Therefore, the threshold determination based on the fixed blood return restriction pressure P _L1 may be used instead of the determination based on the rising slope value.

In FIG. 7, since the graphs 510 and 512 are higher than the blood return limiting pressure P _L1, it is determined that there is a possibility of internal bleeding that may give a sense of incongruity to the donor. Will be done. On the other hand, the graphs 522, 524 and 526 are not limited by the blood return limit pressure P _L1 .

  As shown in FIG. 6, in this response process, the blood pump 28 is stopped (or decelerated) in step S201, predetermined information is displayed on a predetermined acoustic means or monitor 20 in step S202, and the operator is notified. Thereafter, necessary treatment is performed in step S203, and when the operator determines in step S204 that the blood return can be resumed, the blood return is resumed by pressing a resume button (not shown). If it is determined that the blood return cannot be resumed, the necessary treatment is performed, and then a stop button (not shown) is pressed to interrupt the blood return.

  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 not, the process returns to step S104. .

  The processing in steps S101 to S109 so far can be classified as differential pressure threshold determination processing for convenience, and in FIG. 7, the region on the left side of A = 2.5 corresponds. Further, the following processing can be classified as pressure value inclination determination processing for convenience, and in FIG. 7, the region on the right side of A = 2.5 corresponds.

  In step S110, whether or not the cumulative rotational speed A has increased by 0.25 with reference to the time (step S105 or S111) at which the donor pressure Pd was measured last time, that is, whether or not the blood pump 28 has made 0.25 revolutions. Confirm. When the rotation is 0.25, the process proceeds to step S111. When the rotation is less than 0.25, the process waits.

  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.

In step S112, the second differential pressure ΔP2 is obtained as ΔP2 ← Pd _N −Pd _N−2 . Here, the subscripts N and N-2 indicate the order in which the donor pressure Pd is measured, the subscript N indicates the value measured in the immediately preceding step S105, and the subscript N-2 is It is a value measured two times before. Since this series of processing is performed every time the blood pump 28 rotates 0.25, Pd _N-2 is the donor pressure Pd when the blood pump 28 is 0.5 rotations before.

Thus, by obtaining the second differential pressure ΔP2 at a predetermined interval, the influence of noise or the like can be reduced. This second differential pressure ΔP2 indicates the inclination of the donor pressures Pd and Pd ₀ .

In step S113, it is checked whether or not the second differential pressure ΔP2 that is the gradient of the donor pressure Pd exceeds the gradient threshold value P _L2 of a predetermined gradient (that is, 20 mmHg / 0.5 rev). That is, the second differential pressure ΔP2 is compared with the inclination threshold value P _L2, and when ΔP2 ≧ P _L2 , the process proceeds to step S114, and when ΔP2 <P _L2 , the process proceeds to step S114.

The determination in step S113 is for probabilistically checking for signs of internal bleeding that may give the donor a sense of incongruity. In FIG. 7, when the second differential pressure ΔP2 is equal to or greater than the inclination threshold value P _L2 , branch processing is performed. Thus, the return of blood is interrupted in step S114 of the handling process to prevent internal bleeding.

The possibility of giving the donor a sense of incompatibility when returning blood to a steady state (for example, the cumulative rotational speed A is 2.5 or later) is that the fluctuation range at a predetermined time is greater than the slope threshold value P _L2 in FIG. It is confirmed by the inventor's research that this is a large time. This is because the donor pressure Pd ₀ starts to rise based on the fact that the blood collection needle 100 that has been properly punctured at the beginning is displaced for some reason, and the blood return component is not being accurately supplied to the vein. it is conceivable that.

In FIG. 7, regarding the graph 526, the fluctuation range per 0.5 rotation is larger than the inclination threshold value P _L2 in the region where the cumulative rotation speed A is about 12 times or more, which may give the donor a sense of incongruity. It is determined that there is a possibility of internal bleeding, and the corresponding process of step S114 is performed. On the other hand, the graphs 522 and 524 are not limited by the inclination threshold value P _L2 .

As is clear from FIG. 7, by performing the process using the inclination threshold value P _L2 , it is possible to make a quick determination when the graph 526 starts to rise, and the donor pressure is determined based on the determination based on the blood return restriction pressure P _L1. Detection is possible in a shorter time than when Pd ₀ reaches 100 mmHg.

  The corresponding process in step S114 is the same process as in step S108.

  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 returning blood.

  Next, a method for obtaining the first differential pressure ΔP1 and the second differential pressure ΔP2 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 ad0 to ad10. The memory 600 is used as a so-called ring buffer.

  8A to 9B, the symbol shown at each address ad0 to ad10 is the donor pressure Pd, and P0 is the initial pressure. PN (N = 1, 2, 3,...) Represents the donor pressure Pd obtained for the Nth time.

  First, the initial pressure P0 obtained in step S101 of the differential pressure threshold determination process is recorded in all of the addresses ad0 to ad10 as shown in FIG. 8A.

  The donor pressure Pd = P1 obtained at the first time is recorded at an address ad0 as shown in FIG. 8B. The first differential pressure ΔP1 at this time is ΔP1 ← P1−P0, and is obtained by subtracting the value of the adjacent address ad1 (P0) from the value of the address ad0 (P1) by the address pointer operation. For example, the address pointer operation may be set so that +1 is updated every time data is written to the address indicated by the address pointer, and the value of the address indicated by the updated address pointer may be read as P0. The address pointer I takes a value from 0 to 10, and when I = 11, I ← 0.

  In FIG. 8B and subsequent figures, hatched addresses indicate portions that are referred to for obtaining the first differential pressure ΔP1 or the second differential pressure ΔP2.

  The donor pressure Pd = P2 obtained at the second time is recorded at the address ad1 as shown in FIG. 8C. The first differential pressure ΔP1 at this time is ΔP1 ← P2−P0, and is obtained by subtracting the value of the adjacent address ad2 (P0) from the value of the address ad1 (P2) by the address pointer operation.

  Thereafter, similarly, the donor pressure Pd is sequentially recorded in ascending addresses, and the first differential pressure ΔP1 is obtained by subtracting the value of the address next to it (that is, P0).

  Next, the donor pressure Pd = P11 obtained first in step S111 of the pressure value inclination determination process is recorded at an address ad10 as shown in FIG. 9A. The second differential pressure ΔP2 at this time is ΔP2 ← P11−P9, and is obtained by subtracting the value of the address ad8 (P9) next to it from the value of the address ad10 (P11) by the address pointer operation.

  For example, when the address pointer operation is set so that +1 is updated every time data is written to the address indicated by the address pointer I, the value of the address indicated by I-3 is P11, and the value of the address indicated by I-2 Is P9. Of course, the address pointer operation is not limited to this.

  The donor pressure Pd = P12 obtained for the second time in step S111 is recorded at the address ad0 as shown in FIG. 9B. The second differential pressure ΔP2 at this time is ΔP2 ← P12−P10, and is obtained by the address pointer operation.

  Thereafter, similarly, the donor pressure Pd is sequentially recorded in the ascending order in the range of ad0 to ad10, and after recording in ad10, it returns to ad0 and is recorded again. The second differential pressure ΔP2 is obtained by subtracting the value of the two adjacent addresses.

As described above, according to the blood component collection device 10 according to the present embodiment, when the blood pump 28 is rotated during blood return, the second differential pressure ΔP2 that is the gradient of the donor pressure Pd is a predetermined gradient. By decelerating or stopping the blood pump 28 when the inclination threshold value P _L2 is exceeded, it is possible to predict and prevent the occurrence of internal bleeding that may give the donor a sense of incongruity.

  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 cumulative liquid supply amount A ′ and the cumulative rotation speed A can be converted into each other by the relational expression of A / A ′ = 1.15, for example, according to the specification of the blood pump 28. The blood return elapsed time T is an accumulated time during which the blood pump 28 is operating in the blood return process (blood return process).

In the above description, in the differential pressure threshold determination process until the cumulative rotational speed A reaches A = 2.5 times, the first differential pressure ΔP1 and the fixed blood return restriction pressure P _L1 are compared and determined. However, it can also be said that this is a kind of pressure value inclination determination processing in which the cumulative rotational speed A is A = 2.5 times or later.

That is, the first differential pressure ΔP1 is a difference between the donor pressure Pd at the time of the cumulative rotational speed A and the initial pressure P0, and its inclination is ΔP1 / A. The blood return limiting pressure P _{L1 to be} compared at that time is expressed as P _L1 / A as the slope threshold. The comparison determination ΔP1 ≧ P _L1 in step S107 can also be expressed as ΔP1 / A ≧ P _L1 / A. Therefore, the comparison determination is the same as in step S113, and the pressure value inclination determination process is performed. It can be said that it is a kind.

Next, a second embodiment of the blood return process performed in step S10 (see FIG. 4) will be described with reference to FIG. The following processing is performed each time for blood return processing that is performed a plurality of times. The second embodiment basically performs the same process as the first embodiment. In the first embodiment, the blood return restriction pressure P _L1 is initially set, and thereafter, the inclined region P _L2 is set. However, in the second embodiment, the inclined region P _L3 is initially set, and thereafter, the inclined region P _L4 is set.

  The second embodiment of the blood return process is performed as the process shown in FIG. Steps S301 to S315 in FIG. 10 correspond to steps S101 to S115 in FIG. 5 in the first embodiment, and steps S302, S306, S307, and S313 are different from the processing in the first embodiment.

In step S302, the inclined region P _L3 and the inclined region P _L4 are set. The inclination threshold value P _L3 is an allowable fluctuation range during the 0.25 rotation of the blood pump 28 in a period of A <2.5, and is set to 10 to 50 mmHg, for example. In the second embodiment, the inclination threshold value P _L3 is set to 20 mmHg. The inclination threshold value P _L3 is shown in FIG. 7 with 20 mmHg / 0.5 rotation.

The inclination threshold value P _L4 is a variation allowable width while the blood pump 28 rotates 0.5 times in a period of A ≧ 2.5, and is the same parameter as the inclination region P _L2 described above. The inclined region P _L2 is set to 10 to 50 mmHg, for example. In the second embodiment, the inclination threshold value P _L4 is set to 20 mmHg, which is the same as that of the inclination region P _L2 . The slope threshold value P _L4 is illustrated in FIG.

  Step S306 is a process for obtaining the differential pressure ΔP1 during the period of A <2.5, and the same process as in step S112 is performed.

Step S307 is the same process as step S107 described above, and uses the gradient threshold value P _L3 instead of the blood return limiting pressure P _L1 to perform a comparison process with the differential pressure ΔP1.

Step S313 is the same process as step S113 described above, and uses the inclination threshold value P _L4 instead of the inclination threshold value P _L2 to perform a comparison process with the differential pressure ΔP2.

  According to the second embodiment, the same effect as that of the first embodiment can be obtained.

In addition, the inclination threshold value P _L3 may be set with a variation allowable width during which the blood pump 28 rotates 0.5 times similarly to the inclination threshold value P _L4, and in this case, for example, is set to 20 to 100 mmHg.

  Next, a third embodiment of the blood return process performed in step S10 (see FIG. 4) will be described with reference to FIGS. The following processing is performed each time for blood return processing that is performed a plurality of times.

  First, in step S401 in 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 continuously acquired every minute time by a predetermined processing unit.

  In step S402, the blood return limit pressure Pl is set to 170 to 240 mmHg. In the third embodiment, the blood return limit pressure Pl is set to 200 mmHg. The blood return limit pressure Pl is a pressure value that serves as a reference for performing a predetermined process such as lowering the rotation speed of the blood pump 28 in order to lower the donor pressure Pd when the obtained donor pressure Pd exceeds. In other words, the blood return limit pressure Pl is a substantial limit pressure that limits the upper limit of the donor pressure Pd. A control procedure by the control unit 26 when the blood return restriction pressure Pl is set to 200 mmHg and 150 mmHg will be described later.

  In step S403, the blood pump 28 is rotated to start blood return. The blood pump 28 is rotated in the opposite direction to the normal direction at the time of 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 so as to perform acceleration until reaching the blood return rate set value of 90 mL / min. Further, the blood return restriction pressure Pl is set to +200 mmHg in the initial state, and is always controlled so that the donor pressure Pd becomes equal to or lower than the blood return restriction pressure Pl when the donor pressure Pd exceeds the blood return restriction pressure Pl. .

  The blood return speed V is expressed as a negative value because the blood collection speed at the time of blood collection is defined as a positive value (see FIG. 14).

  In step S404, 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 S405, and if it has not reached, the process waits.

  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.

  In step S406, the differential pressure ΔP is confirmed. When ΔP ≧ 100 mmHg, the process proceeds to step S407, and when ΔP <100 mmHg, the process proceeds to step S411.

  The determination in step S406 is to probabilistically check for signs of internal bleeding that may 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 slope of the donor pressure Pd is the point. When the inclination is equal to or greater than the inclination of P11 to P12, branch processing is performed and blood return is interrupted by the following steps S407 to S409 to prevent internal bleeding.

  It is confirmed by the inventor's research that there is a possibility of giving a sense of incongruity to the donor in the range above the threshold line 501 (stop threshold) in FIG. Therefore, the determination process corresponding to step S406 is not necessarily performed only at the point P11, but may be performed at the other end point P12 (a place where the cumulative rotational speed A is about 6), or the points P11 to P12. It may be performed once or a plurality of times. The threshold straight line 501 is represented by the following formula (1) or (2).

Pd = 27 × A + 14 (mmHg) (1)
Pd = 31 × A ′ + 14 (mmHg) (2)
Here, A ′ is a cumulative liquid supply amount (mL) by the blood pump 28.

  In FIG. 14, since the graphs 510 and 512 are above the threshold line 501, it is determined that there is a possibility of internal bleeding that may give the donor a sense of incongruity, and the following processing in step S 407 is performed. It will be.

  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 that may give the donor a sense of incongruity as it is, and graphs 514 indicated by bold lines, 516 and 518 are cases in which it is determined that there is a possibility of internal bleeding that does not cause a sense of incongruity to the donor as it is, and graphs 520, 522, and 524 indicated by thin lines are determined to have no possibility of internal bleeding. This is the case.

  Of these, the graphs 514, 516, and 520 exceed the threshold straight line 502 (restriction threshold), but are actually limited by lowering the blood return restriction pressure Pl to 150 mmHg as described later. .

  14 and 15, the vertical axes 530, 532, and 534 are lines that representatively indicate locations where the blood return speed V of the blood pump 28 reaches 50 mL / min, 60 mL / min, and 90 mL / min.

  In step S407 (pressure determination process), the blood pump 28 is stopped, and in step S408, predetermined information is displayed on the predetermined acoustic means or the monitor 20, and the operator is notified. After this, if it is determined in step S410 that the operator can resume the blood return, a restart button (not shown) is pressed to return to step S401, where blood return cannot be resumed. If it is determined, the necessary treatment is performed, and then a stop button (not shown) is pressed to suspend blood return.

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

  In step S412, the donor pressure Pd is confirmed. If Pd> 100 mmHg, the process proceeds to step S413, and if Pd ≦ 100 mmHg, the process proceeds to step S416 (see point P22 in FIG. 14).

  The determination in step S412 is one of means for proactively examining the presence or absence of signs of internal bleeding in which the donor does not feel uncomfortable. When the donor pressure Pd exceeds the threshold straight line 502 (limit threshold), the blood return limit pressure Pl Adjust appropriately to prevent internal bleeding.

  Therefore, the determination process corresponding to step S412 is not necessarily performed only at the point P22, but may be performed at the other end point P21 (a place where the cumulative rotational speed A is about 2.65), or the points P21 to P21. You may perform once or several times between P22. The threshold straight line 502 is expressed by the following formula (3) or (4).

Pd = 6 × A + 32 (mmHg) (3)
Pd = 7 × A ′ + 32 (mmHg) (4)
As described above, A ′ is a cumulative liquid supply amount (mL) by the blood pump 28.

  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 expression (1) or (2).

  The threshold lines 501 and 502 are not necessarily fixed, and may be changed empirically or may be curved. Moreover, you may change with a donor's weight, sex, the blood flow velocity in the blood vessel of a puncture part, etc.

  Here, the donor pressure Pd exceeding the threshold line 502 is a first case in which internal bleeding may occur in which the donor does not feel uncomfortable, and the waveform of waveforms such as graphs 514, 516, and 518 in FIG. In this case, the inventor's research has confirmed 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 distal end of the blood collection needle 100 is increased, and that the blood leaks from the gap between the needle and the blood vessel wall, so that it shifts to an internal bleeding state.

  In the second case in which internal bleeding in which the donor does not feel uncomfortable may occur, the study of the present inventor confirmed that the donor pressure Pd shows a change in a mountain shape in FIG. This is considered to be a sign of transition to the internal bleeding state for the same reason as in the first case. Such a second case is determined 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.

  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 blood return limiting pressure Pl is set to 150 mmHg in step S425. After lowering, the process proceeds to step S426, and otherwise, the process proceeds to step S415.

  The determination in step S414 is determined by switching the supplied differential value from a positive value to a negative value. Further, according to the research of the present inventor, it has been confirmed that there is a sign of internal bleeding particularly in the case of a convex convex chevron upward in the change of chevron. In order to determine such a sharp convex chevron, as shown in FIG. 16, the supplied differential value 550 has a predetermined width D centered on 0 from a positive value to a negative value in a predetermined short period of time. Judged by sudden change beyond. Or you may judge by the 2nd-order differential value 552 of the donor pressure Pd having fallen below the 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.

  In FIG. 14, it is determined in step S414 that the graph 514 indicates 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. The process proceeds to step S425.

  In FIG. 14, since the graphs 516, 518 and 520 are above the threshold line 502, it is determined that there is a possibility of internal bleeding that does not give the donor a sense of incongruity, and the following processing in step S415 is performed. Will be done.

  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.

  14 and 15, graphs 522 and 524 show a tendency that the donor pressure Pd temporarily decreases in the range where the cumulative rotational speed A is in the range of 10 to 20, but this is in the middle of the blood return circuit. The blood that was present in the blood flowed in the direction of the donor, mixed with red blood cells in the air trap chamber, the hematocrit value of the blood coming out of the chamber 106 decreased, and the blood with such a low hematocrit value passed through the blood collection needle 100 This is because a temporary decrease in passage resistance occurs.

  In step S415, the blood return limit pressure Pl in step S402 is set to +120 to +170 mmHg. In this embodiment, the blood return limiting pressure Pl is lowered from 200 mmHg to 150 mmHg, and 1 is set to a flag F of 0 in the initial state.

  In the process of step S415, the blood return restriction pressure Pl 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 forcibly discharged into the donor's vein. As a result, internal bleeding can be prevented and suppressed.

  Further, as a means for preventing / suppressing internal bleeding, speed limitation may be performed in addition to pressure limitation. That is, the blood return rate setting value set to 90 mL / min in the initial state 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.

  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 donor pressure Pd is a mountain shape, the process proceeds to step S426, and otherwise, the process proceeds to step S418. Move.

  In FIG. 14, it is determined in step S417 that the graph 520 indicates a chevron at a location where the cumulative rotational speed A is greater than 10, and it is determined that there is a possibility of generating internal bleeding that may give the donor a sense of discomfort. The process proceeds to 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.

  When the condition of step S418 is satisfied, it is determined that the sign of internal bleeding does not disappear after the blood return restriction pressure Pl is lowered, and the blood return is interrupted by the processes of steps S407 to S410.

  In step S419, the blood return rate setting value at that time is confirmed. If the value is 50 mL / min or less, the process proceeds to step S424, and if it exceeds 50 mL / min, the process proceeds to step S420. In addition, this value can be set in the range of 5-55 mL / min.

  In step S420, the blood return speed is acquired, and an average value for the past one minute is obtained by a moving average or the like.

  In step S421, the average value of the obtained blood return speeds for the past one minute is confirmed, and when the value exceeds 50 mL / min as the flow rate threshold, the process proceeds to step S423, and when it is 50 mL / min or less, step S422 is performed. Move on.

  The determination in step S421 is one of means for proactively examining the presence or absence of signs of internal bleeding that the donor does not feel uncomfortable. The blood return restriction pressure Pl is appropriately adjusted by the processing in the following step S422, and the internal bleeding Prevent outbreaks.

  That is, when the average blood return rate is thus reduced, this is a 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. It is determined that there is a possibility that the blood collection speed may not increase in the blood collection process of the next cycle, and predetermined precautions are taken.

  On the other hand, if the average blood return speed has not decreased, it is determined that the possibility of internal bleeding that the donor does not feel uncomfortable is low, and the blood return is continued as it is.

  Note that when the blood return rate set value is 50 mL / min or less, it is natural that the average blood return rate is also lowered, and therefore step S421 is bypassed by the branch determination in step S419.

  In step S422, the blood return restriction pressure Pl is lowered to 150 mmHg, 1 is set in the flag F, and the process proceeds to step S424.

  In step S423, the blood return restriction pressure Pl is returned to 200 mmHg, and the flag F is set to 0.

  In the process of returning the blood return restriction pressure Pl, for example, the restriction may be gradually relaxed by 10 mmHg while observing the situation without returning to 200 mmHg at a time.

  In step S424, 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 FIGS. 11 to 13 is terminated, and otherwise, step S416 is performed. Return to continue to return blood.

  On the other hand, in step S426, the accumulated rotational speed A is acquired, and in step S427, it is confirmed whether A ≧ 35. When A ≧ 35, the process proceeds to step S428, and when A <35, the process returns to step S426 and waits.

  In step S428, the blood return speed V at that time is compared with the blood return speed setting value. If blood return speed V <blood return speed set value, the process proceeds to step S416, where blood return speed ≧ blood return speed set value. If there is, the process proceeds to step S429.

  In this determination of step S428, the blood return restriction pressure Pl has been lowered to 150 mmHg proactively before that, but it has been confirmed that no internal bleeding has occurred from the subsequent situation, and the original blood return situation (blood return restriction pressure Pl And the blood return speed V etc.) for quick blood return.

  Such 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. Conditions may be used.

  That is, (2) The cumulative rotational speed A when the blood return speed V ≧ the blood return speed set value is smaller than a predetermined value (20 to 60), for example, A <35. (3) The set value in the range from the start of blood return to the donor pressure Pd in the range of +100 to +200 mmHg, for example, the time until the donor pressure Pd reaches +150 mmHg is in the range of 5 to 20 sec, for example, 34 sec or more. (4) When the elapsed time from the start of blood return is a set value in the range of 5 to 20 sec, for example, 34 sec, the donor pressure Pd has not reached the set value in the range of +100 to +200 mmHg, for example, +150 mmHg. (5) A set value in the range of the donor pressure Pd from +100 to +200 mmHg from the start of blood return, for example, the cumulative rotational speed A until reaching +150 mmHg is smaller than a predetermined value (20 to 60), for example, A> 35 thing.

  In other words, the relationship between the cumulative rotational speed A or elapsed time and the donor pressure Pd or blood return speed V (that is, the donor pressure Pd is the recovery judgment pressure threshold value +150 mmHg depending on the cumulative rotational speed A or elapsed time) Or the blood return speed V exceeds the recovery judgment flow rate threshold value 50 mL / min), it can be determined that internal bleeding does not occur, and the blood return restriction pressure Pl or the blood return speed limit value is Any combination other than the above may be used.

  The recovery judgment flow rate threshold can be set in a range from 20 mL / min to the smaller of 2/3 of the set speed and 60 mL / min.

  When these conditions are satisfied, it can be determined that internal bleeding does not occur, and a return process may be performed in the following step S429.

  In step S429, the blood return restriction pressure Pl is returned to 200 mmHg, 0 is set in the flag F, and the process proceeds to step S416. In addition, when the restriction is performed not by the pressure but by the speed, the blood return speed setting value reduced to 60 mL / min may be returned to the original 90 mL / min.

  For example, the above condition (5) can be determined based on the point P3 in FIG. When the determination is made based on the condition (5), the graph 520 initially shows a mountain-shaped waveform and the blood return restriction pressure Pl is limited to 150 mmHg, but when A = 35, Pd <+150 mmHg. Therefore, it can be determined that internal bleeding does not occur, and the blood return limit pressure Pl can be returned to 200 mmHg in step S429. On the other hand, in the graph 518, the blood return limiting pressure Pl 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. When returning to the above situation, the possibility of internal bleeding cannot be excluded, and the blood return limiting pressure Pl is limited to 150 mmHg.

  Next, a procedure for controlling the rotational speed N of the blood pump 28 during blood collection and blood return will be described. The rotation speed N is performed by performing acceleration / deceleration based on the section of the donor pressure Pd. This acceleration / deceleration is defined based on the flow rate converted value, and is updated and controlled at intervals of about 50 msec. This interval can be set in the range of 25 to 200 msec.

  First, at the start of blood collection, it starts from a set value of 0 to +150 mL / min.

  At the time of blood collection, when the donor pressure Pd is not less than the set value of +220 to +300 mmHg or less than the set value of −300 to −100 mmHg, it is determined that the pressure is abnormal, and the rotation of the blood pump 28 is stopped. An error handling process is performed.

  When the donor pressure Pd is in a range not less than the set value of −50 to +30 mmHg and less than the set value of +20 to +300 mmHg, acceleration is performed within the range up to the set speed with an acceleration of the set value of +2 to +90 mL / min / sec. .

  When the donor pressure Pd is in the range of -100 to -5 mmHg or more and less than the setting value of -50 to +20 mmHg, the acceleration is within the range up to the set speed with the acceleration of the setting value of +1 to +10 mL / min / sec. I do.

  When the donor pressure Pd is in the range of not less than the set value of −200 to −50 mmHg and less than the set value of −150 to −20 mmHg, the flow rate is reduced to 0 with a deceleration of −5 to −50 mL / min / sec. Decelerate within the range.

  When the donor pressure Pd is in the range of not less than the set value of −280 to −80 mmHg and less than the set value of −200 to −50 mmHg, the flow rate is reduced to 0 with the deceleration of the set value of −100 to −10 mL / min / sec. Decelerate within the range.

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

  Next, at the time of blood return, at the start of blood return, the rotational speed N of the blood pump 28 is an initial value in terms of discharge amount, and starts from 20 mL / min when the predetermined set speed is 20 mL / min or more, and is less than 20 mL / min. In this case, the vehicle starts from the set speed and accelerates.

  When the donor pressure Pd is less than the set value of −300 to −100 mmHg, it is determined that the pressure is abnormal, the rotation of the blood pump 28 is stopped, and predetermined countermeasure processing is performed.

  Next, a case where the blood return restriction pressure Pl is set to the initial state of 200 mmHg 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 to +300 mmHg, it is determined that the pressure is abnormal, the rotation of the blood pump 28 is stopped, and a predetermined abnormality handling process is performed.

  When the donor pressure Pd is in the range of not less than the set value of +155 to +300 mmHg and less than the set value of +220 to +300 mmHg, deceleration is performed at a deceleration of −100 to −10 mL / min / sec.

  When the donor pressure Pd is in the range of not less than the set value of +120 to +250 mmHg and less than the set value of +155 to +260 mmHg, deceleration is performed at a deceleration of −2 to −100 mL / min / sec.

  When the donor pressure Pd is in the range of not less than the set value of +20 to +200 mmHg and less than the set value of +150 to +250 mmHg, a hysteresis process is performed, and it is first confirmed whether deceleration is in progress or acceleration is in progress.

  When deceleration is in progress, deceleration is continued at a deceleration of a set value of −2 to −100 mL / min / sec. When the acceleration is in progress, the acceleration is continued within the range up to the set speed with the acceleration of the set value of +2 to +90 mL / min / sec.

  When the donor pressure Pd is in the range of not less than the set value of −220 to −50 mmHg and less than the set value of +20 to +200 mmHg, acceleration is performed within the range up to the set speed with the acceleration of the set value of +2 to +90 mL / min / sec. .

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

  By such processing, appropriate speed control is performed at the time of blood collection and blood return.

  In the above description, the one-arm collection method in which blood is returned after blood collection is taken as an example, but it is needless to say that the present invention can be applied to a bi-arm continuous method in which blood collection and blood return are performed simultaneously. 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.

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

  In this case, when the donor pressure Pd is in the range of not less than the set value of +100 to +200 mmHg and less than the set value of +200 to +300 mmHg, deceleration is performed with a deceleration of the set value of −100 to −10 mL / min / sec.

  When the donor pressure Pd is in the range of not less than the set value of +90 to +220 mmHg and less than the set value of +100 to +200 mmHg, deceleration is performed with a deceleration of the set value of −2 to −100 mL / min / sec.

  When the donor pressure Pd is in the range of not less than the set value of +20 to +150 mmHg and less than the set value of +90 to +220 mmHg, a hysteresis process is performed, and it is first confirmed whether deceleration is in progress or acceleration is in progress.

  When deceleration is in progress, deceleration is continued at a deceleration of a set value of −2 to −100 mL / min / sec. When the acceleration is in progress, the acceleration is continued within the range up to the set speed with the acceleration of the set value of +2 to +90 mL / min / sec. In other cases, the control may be performed similarly to the case where the blood return restriction pressure Pl is set to 200 mmHg.

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

  Further, in both cases of blood collection and blood return, as a result of performing the above-described pump control, the rotational speed N of the blood pump 28 becomes 0, and this state has elapsed for a predetermined time (for example, 3 to 60 seconds). Alternatively, when a predetermined time (for example, 3 to 180 seconds) is accumulated, it is preferable to notify the operator (error screen display, alarm sound, or lamp lighting) to prompt a predetermined process. In this case, when the operator performs a treatment such as correction of 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.

  It goes without saying that the control procedure of the blood pump 28 based on the blood return limit pressure Pl is not limited to this.

  Of course, the cumulative rotational speed A in each of the above descriptions may be replaced by, for example, the cumulative liquid feeding amount A ′.

Claims (5)

After separation of the blood collected from the donor, Oite a predetermined blood component in the blood component collection equipment for returning blood to the donor,
A blood return line for returning blood residual blood components to the donor,
And blood pump of variable speed pump blood components to the blood return line,
A pressure sensor for detecting the pressure (Pd) of said blood return line,
A control unit for driving the blood pump,
Have
Wherein the control unit sets the limit value of the blood return line of the pressure (Pd) or the blood return velocity (V) in accordance with the conditions rather based on the pressure sensor or we obtained the pressure (Pd) ,
The conditions are as follows: when the blood pump is rotated and blood return is started, the pressure (Pd) is classified according to the cumulative rotational speed, cumulative liquid supply amount, or blood return elapsed time of the blood pump. blood component collection equipment, which is a condition that exceeds the limit set for the threshold. Oite blood component collection equipment according to claim 1,
Wherein, when that rotates the blood pump from the start of blood return, the pressure (Pd) corresponds to the accumulated number of rotations of the blood pump, the cumulative flow volume or the blood return elapsed time when exceeding the set the even larger stop threshold value below the limit for the threshold value each, or the when the slope of the pressure (Pd) exceeds a predetermined inclination, and characterized by slowing or stopping the blood pump blood component collection equipment to be. Oite blood component collection equipment according to any one of claims 1 or 2,
The conditions may further blood component collection equipment, which comprises a condition that shows a chevron change the descending after the pressure (Pd) is increased. Oite blood component collection equipment according to any one of claims 1 to 3
Wherein the control unit includes a speed detector for detecting a blood return velocity (V) of the blood return line,
The conditions may further blood component collection equipment to the blood return velocity (V) is characterized in that it comprises a condition that less than a predetermined flow rate threshold. Oite blood component collection equipment according to any one of claims 1-4,
Wherein, after reducing the limit value of the pressure (Pd) or the blood return velocity (V) of the blood return line in response to the condition, the cumulative rotational speed of the blood pump, the cumulative flow volume or according to the elapsed time, when the pressure (Pd) is below a predetermined recovery judgment pressure threshold, or said blood return velocity (V) exceeds a predetermined restoration determination flow rate threshold, the blood return line blood component collection equipment, characterized in that to increase the limit value of the pressure (Pd) or the blood return velocity (V) of the.

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