JP3207953B2 - Blood collection device and plasma collection device - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a blood collecting apparatus and a blood collecting apparatus used for collecting blood or plasma from blood. In particular, it relates to a decompression / pressurization type blood sampling device and a plasma sampling device.

[0002]

2. Description of the Related Art Conventionally, whole blood has been collected using a blood collecting apparatus having a decompression function. Such devices have a relatively simple structure and are compact. Further, recently, a plasma collection device has been proposed in which a collected blood is pressurized by providing not only a decompression function but also a pressurization function, and the collected blood is separated through a membrane-type plasma separator to collect plasma. These devices have advantages such as miniaturization and simplified operation, use in mobile facilities (for example, blood collection vehicles), and easy plasma collection. With the spread of such devices, it is desired that component blood donation increase.

[0003]

The blood collection in such a blood collecting apparatus or plasma collecting apparatus is performed by reducing the pressure in the blood collecting container storage chamber storing the blood collecting container. However, the decompression is to uniformly decompress all blood-collecting persons at the set decompression degree. Only when blood collection does not proceed smoothly due to, for example, a narrow blood vessel of the blood collector, the blood pressure is reduced and the blood collection is performed as poor blood collection. However, since the degree of decompression at which blood can be collected smoothly varies depending on the blood vessel thickness, total blood volume, blood pressure, etc. of the blood collector, collecting blood at a uniformly set decompression degree is not sufficient in terms of blood collection efficiency. There is a problem,
Blood collection is performed at a lower set decompression degree even for a blood donor who can collect blood at a decompression degree higher than the set decompression degree, which causes a long time for blood collection. Conversely, even for blood donors who cannot perform blood collection smoothly at the set decompression degree, blood collection is performed at the set decompression degree, and the decompression degree does not decrease unless blood collection becomes poor. In many cases, it often caused mental and physical distress. Therefore, an object of the present invention is to automatically adjust the degree of decompression suitable for a blood collector,
It is an object of the present invention to provide a safe blood collection device or plasma collection device that can perform blood collection in a short time, has high blood collection efficiency, and is safe.

[0004]

An object of the present invention is to provide a blood collecting needle, a blood collecting container, and a blood supply tube communicating with the blood collecting needle and the blood collecting container. A blood collection device for controlling a blood collection circuit,
The blood collection device includes a blood collection container storage chamber that stores the blood collection container of the blood collection circuit, a decompression unit for reducing the pressure inside the storage chamber, and detects an amount of blood collected in the blood collection container. Blood volume detection means, and a control unit for controlling the decompression means and the blood volume detection means, the control unit, based on the output signal from the blood volume detection means,
Blood change calculation to calculate the blood change every fixed time during blood collection
Output function and a setting set according to the degree of pressure reduction of the pressure reducing means.
Constant change amount storage function, the blood change amount and the set change amount
And a comparison / judgment function for judging by comparing
By the determination function, the blood change amount is greater than the set change amount.
If it is determined that the pressure is high or almost equal,
As the pressure is increased, the blood change amount is set to the set value.
If it is determined that the amount of change is smaller than the amount of change,
A system for controlling the pressure reducing means during blood collection so as to reduce the pressure.
Control function, and also controls the pressure reducing means of the control unit.
The controlling function controls the blood change amount to be equal to the set change amount.
If the pressure is less than the first set value,
Only by lowering it,
When the blood change amount becomes larger than the set change amount
Sets the pressure reduction degree of the pressure reduction means to a value smaller than a first set value.
Control to increase by the set value of 2, and
The control unit is configured to operate within a set minimum decompression degree or a set maximum decompression degree.
And a blood sampling apparatus for controlling the degree of pressure reduction of the pressure reducing means .

[0005] Further, to achieve the above object, there is provided a blood collection circuit having a blood collection container for collecting whole blood from a blood collector, and an anticoagulant for adding a blood anticoagulant to the collected whole blood. A drug addition circuit, a plasma separation circuit for separating whole blood to which an anticoagulant has been added into a plasma component and a blood component, a plasma storage circuit for storing the separated plasma component, and a blood collection component for the separated blood cell component. A plasma collection device for controlling a plasma collection circuit having at least a blood cell component return circuit for returning, the plasma collection device includes a blood collection container storage chamber that stores the blood collection container of the blood collection circuit. A pressure reducing / pressurizing means for depressurizing or pressurizing the inside of the storage chamber, a blood amount detecting means for detecting an amount of blood collected in the blood collection container, the pressure reducing / pressurizing means, and the blood Control unit that controls the amount detection means Has, the control unit, the blood volume
Based on the output signal from the detection means, the blood
Blood change amount calculation function for calculating the amount of
Set change amount storage function set according to the degree of pressure reduction of the means
And comparing the blood change amount and the set change amount to determine
Has a comparison / judgment function,
When the blood change amount is greater than or substantially equal to the set change amount,
In this case, the degree of decompression of the decompression / pressurization means is increased, and the blood
If the change amount is smaller than the set change amount,
The blood pressure is reduced and pressurized during blood collection so as to reduce the degree of decompression of the pressure means.
A control function for controlling the means;
The control function of controlling the pressure reducing / pressurizing means of the section
If the change amount is smaller than the set change amount,
Decrease the degree of pressure reduction of the pressure means by the first set value, and then compare
・ The blood change amount is set according to the judgment by the judgment function.
If it exceeds the constant change amount,
Increase the degree of decompression by a second set value smaller than the first set value
And the control unit performs setting
Depressurization and pressurization within the minimum decompression degree or the set maximum decompression degree
This is a plasma collection device for controlling the degree of decompression of the means .

[0006] It is preferable that the blood volume detecting means is a blood collection container weight detection unit that detects the weight of the blood collection container of the blood collection circuit. Further, it is preferable that the blood volume detecting means is a flow meter that measures a blood flow rate in the blood collection circuit. Further, it is preferable that the control unit controls the degree of decompression of the decompression means to a predetermined decompression degree higher than the set minimum decompression degree at the start of blood collection. Then, the controller increases the degree of decompression of the decompression means by a predetermined set value when the blood change amount is larger than the set change amount, and when the blood change amount is smaller than the set change amount, It is preferable to control the degree of pressure reduction of the pressure reducing means so as to be reduced by a predetermined set value. Further, when the blood change amount is larger than the set change amount, the control unit increases the degree of decompression of the decompression means by a first set value,
If the blood change amount becomes smaller than the set change amount by increasing the decompression degree of the decompression means by a first set value, control is performed to decrease the decompression degree of the decompression means by a first set value. It is preferable that Further, when the blood change amount is smaller than the set change amount, the control unit lowers the degree of decompression of the decompression means by a first set value. If the number has increased, it is preferable that the pressure reduction degree of the pressure reducing means is controlled to be increased by a second set value smaller than the first set value. Then, the control unit stores the degree of decompression at which the blood change amount becomes the set change amount in the previous blood collection, and at the start of the next blood collection, the pressure reduction /
It is preferable that the pressurizing means is controlled to start blood collection at the stored degree of pressure reduction. Further, the control unit has a decompression degree storage function of storing the decompression degree at or near the end of the previous blood sampling operation, and further, at the start of the next blood sampling, the decompression / decompression unit starts with the stored decompression degree. It is preferable to control the pressurizing means. Further, it is preferable that the control unit stores a maximum pressure reduction degree, a minimum pressure reduction degree, and a plurality of levels of pressure reduction degrees set between the minimum pressure reduction degree and the maximum pressure reduction degree. Then, the controller increases the degree of decompression of the decompression means to a level higher by one when the blood change amount is larger than the set change amount, and when the blood change amount is smaller than the set change amount, It is preferable to control the degree of decompression of the decompression means so as to lower it by one level. Further, when the blood change amount is smaller than the set change amount, the control unit lowers the degree of decompression of the decompression means to a level lower by one, and according to subsequent judgment, the blood change amount is smaller than the set change amount. If the number is large, it is preferable that the pressure reduction degree of the pressure reduction means is controlled to be increased by a second set value smaller than the difference between the two levels.

In order to achieve the above object, a blood collection needle, a blood collection container, a blood collection circuit having the blood collection needle and the blood collection container, and an anti-coagulant for adding a blood anticoagulant to the collected whole blood are provided. A coagulant addition circuit, a plasma separation means for separating whole blood to which an anticoagulant has been added into a plasma component and a blood cell component, a plasma collection container for collecting the separated plasma component, and a blood sampling device for collecting the separated blood cell component A plasma collection device for controlling a plasma separation circuit having at least a blood cell component return circuit for returning to the blood collection container storage chamber for storing a blood collection container of the blood collection circuit, A decompression / pressurization means for decompressing or pressurizing the inside of the storage chamber, a blood volume detection means for detecting an amount of blood collected in the blood collection container, and a control unit for controlling the decompression / pressurization means. The control unit has the blood volume during blood collection. Based on the output signal from the informing means, calculate the blood change amount for each fixed time, further compare the set change amount and the blood change amount set according to the degree of decompression of the decompression / pressurization means, When the blood change amount is greater than or substantially equal to the set change amount, the degree of decompression of the pressure reducing / pressurizing means is increased, and when the blood change amount is smaller than the set change amount, the pressure reducing / pressurizing means is increased. A blood plasma collection device that controls to reduce the degree of decompression. After injecting the anticoagulant into the first blood vessel together with the air inside the blood collection container, depressurizing after the air bleeding / anticoagulant inflow step is completed.・ Activate the pressurizing means After the anticoagulant injection step of injecting a predetermined amount of the anticoagulant from the anticoagulant storage container into the blood collection container and the anticoagulant injection step is completed, the pressure in the blood collection container storage chamber is reduced.・
Activating the pressurizing means to reduce the pressure inside the blood collection container storage chamber, and inside the blood collection container, a predetermined amount of blood from the donor,
A blood collection step of collecting blood while controlling the degree of decompression as described above, and after the blood collection step is completed, the decompression / pressurization means is operated to put the inside of the blood collection container storage chamber into a pressurized state, and blood is collected inside the blood collection container. The collected blood flows into the plasma separator, the plasma component flowing out of the plasma outlet of the plasma separator is collected in a plasma collection container, and the blood cell component flowing out of the blood cell outlet of the plasma separator is returned to the donor. This is a plasma collection device that performs a separation / return step.

Therefore, a blood collecting apparatus or a plasma collecting apparatus of the present invention will be described with reference to the embodiments shown in the drawings. The device of the embodiment is a blood collection device that collects whole blood from a blood collector and a plasma collection device that can collect a plasma component from the collected whole blood. FIG. 1 shows a schematic diagram of the basic configuration of the blood sampling device 1 of this embodiment. FIG. 1 shows a blood sampling device 1 with a single-needle plasma separation circuit attached. FIG. 2 is a perspective view of an embodiment of the blood sampling apparatus of the present invention without a plasma separation circuit attached.

As shown in FIG. 1, the blood collection apparatus 1 of this embodiment includes a blood collection needle 21, a blood collection container 5, and a blood supply tube 2 communicating the blood collection needle 21 and the blood collection container 5. 1 is a blood collection device 1 for controlling a blood collection circuit for collecting blood from a blood collection device. The blood collection device 1 includes a blood collection container storage chamber 41 that stores the blood collection container 5 of the blood collection circuit, and a storage chamber 4.
1 a decompression means 58 for decompressing the inside, and a blood collection container 5
A blood sampling container weight detecting unit 57 which is a blood amount detecting unit for detecting the amount of blood to be collected in the blood collecting unit;

The blood collecting apparatus 1 of the embodiment is also a blood plasma collecting apparatus. An anticoagulant addition circuit for adding an agent, a plasma separation circuit for separating whole blood to which the anticoagulant is added into a plasma component and a blood component, a plasma storage circuit for storing the separated plasma component, It is also possible to control a plasma collection circuit having at least a blood cell component return circuit for returning the obtained blood cell components to the blood sampler. The plasma collection device 1 includes a blood collection container storage chamber 41 that stores the blood collection container 5 of the blood collection circuit, and a storage chamber 4.
1 Decompression / pressurization means 58 for decompression or pressurization of the inside
A blood collection container weight detection unit 57 that is a blood amount detection unit for detecting the amount of blood collected in the blood collection container 5;
It has a control unit 59 for controlling the pressure reducing / pressurizing means 58.

[0011] The blood collection circuit of the plasma separation circuit controlled by the blood collection apparatus 1 of this embodiment is, as shown in FIG.
Blood collection needle 21, blood collection container 5, first blood supply vessel 2 communicating blood collection needle 21 with blood collection container 5, and second blood supply communicating blood collection container 5 with the blood inlet of plasma separator 7. It is constituted by blood vessels 6. As shown in FIG. 1, the anticoagulant addition circuit includes an anticoagulant storage container 45 and an anticoagulant transport pipe 48 that connects the anticoagulant storage container 45 and the blood collection container 5. ing. Further, the plasma separating means includes a plasma separator 7 and a plasma transport pipe 9 connected to a plasma outlet of the plasma separator 7. further,
A plasma collection container 10 is attached to the plasma transport tube 9. The blood cell component return circuit includes a third blood vessel 8 that communicates the blood outlet (blood cell component outlet) of the plasma separator 7 with the first blood vessel 2.

Further, the blood sampling device 1 of this embodiment
As shown in FIG. 1, a rocking means 42 for stirring the collected whole blood and an anticoagulant, a plasma separator mounting portion to which the plasma separator 7 is detachably attached, and a first blood vessel of the plasma separation circuit 2
Circuit opening / closing means 12 for opening / closing the blood vessel, second circuit opening / closing means 13 for opening / closing the second blood vessel 6 or the third blood vessel 8, and third circuit opening / closing means for opening / closing the plasma transport tube 9. Circuit opening / closing means 14, a fourth circuit opening / closing means 46 for opening / closing the anticoagulant transport pipe 48, a pressure detector 55 for detecting the pressure inside the blood collection container storage chamber 41, Pressurizing means 44 for pressurizing cuff 49 attached to the arm
And a pressure detector 5 for detecting the pressure of the cuff 49.
6 and a plasma weight detector 99 for detecting the weight of the plasma collection container 10. The pressure reducing / pressurizing means 58, the pressure detecting unit 56, and the blood collecting container weight detecting unit 5 of the blood collecting container 5.
7. Plasma weight detector 99 of plasma collection container 10, cuff 4
9, the pressure detecting section 56 of the cuff 49, the leak valve 54, the circuit opening / closing means 12, 13, 14, 46
As shown in FIG. 1, all are electrically connected to a control unit 59 having an arithmetic circuit unit such as a CPU. Then, the control unit 59 controls each component as shown in FIGS. 3 to 17 described later.

The blood sampling apparatus 1 according to one embodiment of the present invention will be described more specifically with reference to FIGS. As shown in FIG. 1, the blood collection device 1 is configured such that the first blood supply vessel 2, the second blood supply blood vessel 6, and the anticoagulant transport pipe 48 are connected via a tube connected to the blood collection container 5 and a branch pipe 95.
It communicates with the blood collection container 5. And the blood collection device 1
As shown in FIG. 2, a lid 8 is provided on the upper surface so as to be inclined.
3, and the lid 83 is provided with a lid open / close detection unit. The lid opening / closing detecting section is configured, for example, such that a magnet and a Hall IC (not shown) are provided on the lid 83 and open / closed is detected using both. Inside the lid 83, a blood collection container storage chamber 41 which is a closed space when the lid 83 is closed is formed. It is provided.

A decompression / pressurization means 58 is connected to the blood collection container storage chamber 41.
The depressurizing / pressurizing means 58 can pressurize and depressurize. The decompression / pressurization means 58 is, as shown in FIG.
It comprises an air supply / exhaust circuit 53, a vacuum pump 43, two 3-port valves (pressure reduction / pressure switching valves) 51, 52, and a leak valve 50. The depressurizing / pressurizing means 58 sets the depressurized state to -100 to -200 mmHg by 10 mm.
Hg can be set for each Hg.
The configuration is such that +200 mmHg can be set every 10 mmHg. The degree of pressure reduction or degree of pressurization can be adjusted by controlling the vacuum pump 43 by a control unit 59 described later. The adjustment can also be made by the front panel 80 shown in FIG. The switching between the depressurized state and the pressurized state is performed by controlling the three-port valves 51 and 52 by the control unit 59.
This is performed by N / OFF control. Specifically,
The three-port valves 51 and 52 are in a ventilation state when in an on state, and are open to the atmosphere when in an off state. Therefore,
If only the three-port valve 51 is turned on (the three-port valve 52 is turned off), the vacuum pump 43 operates to evacuate, and the inside of the blood collection container storage chamber 41 shown in FIG. Conversely, if only the three-port valve 52 is turned on (three-port valve 51 is turned off), suction is performed by the operation of the vacuum pump 43, and the inside of the blood collection container storage chamber 41 is pressurized.

The blood collection container 5 is set on the storage table 98 in the blood collection container storage chamber 41 such that the tube connection side is lowered (toward the front side). In addition, below the storage table 98, a blood collection container weight detection unit 57, for example,
A weight sensor is provided. The blood collection container weight detection unit 57 detects the weight of blood in the blood collection container 5 and constitutes a blood volume detection unit. As the blood collection container weight detection unit 57, a load cell can be suitably used. The blood volume detecting means may be any device capable of detecting the amount of blood collected in the blood collecting container 5, and is not limited to the blood collecting container weight detecting unit 57. For example, a flow meter may be provided as a blood volume detection means in the blood supply vessel 2 of the blood collection circuit.

Further, at the lower part of the blood sampling container storage table 98, a swinging portion constituted by a swinging motor and a crank mechanism, and a disk attached to a shaft of the swinging motor and rotating with the rotation of the swinging motor. A first slit provided on the disk, a second slit provided at a position 180 ° away from the first slit, and a third slit provided near a position where the second slit is provided. Swinging means 42 for stirring the whole blood and the anticoagulant in the blood collection container 5
Is provided. The first slit and the second slit are provided to stop the rotation of the swing motor near the top dead center or the bottom dead center of the crank mechanism, respectively. The first slit and the second slit are provided at positions in consideration of the amount of rotation of the rocking motor until the slit detecting means 67 described later detects the slit and the control unit 59 stops the rocking motor. ing. Also,
The third slit is provided from the slit detecting means 67 to the control unit 5.
9, when the input signal is sent to the first slit
Or not by, or whether by a second slit,
This is provided so that the control unit 59 can make a determination. The third slit is preferably provided at a position between + 80 ° and + 10 °, where the position where one slit is provided is 0 ° and the rotation direction of the swing motor is a plus direction. In this embodiment, the third
Is provided at a position + 30 ° from the position where the second slit is provided (this position is defined as 0 °). Thereby, the control unit 59 determines that the slit is the second slit when the swing motor rotates 30 ° after the slit detection unit 67 detects one slit, and again detects the slit. Can be determined.

The blood sampling device 1 is provided with
Has a slit detecting means 67 for detecting a slit provided on the disk. The slit detecting means 67 is electrically connected to the control section 59, and sends an output signal to the control section 59 when detecting the first to third slits provided on the disk of the swing means 42. As the slit detecting means 67, an optical sensor, an ultrasonic sensor, or the like can be suitably used. In this embodiment, an optical sensor having a light emitting element and a light receiving element is mounted on the outer surface of a housing of a swing motor. Further, in the above description, the case where a slit is used has been described. However, the present invention is not limited to the slit.
As the detecting means 67, a magnetic sensor for detecting the magnetic index may be used.

In this embodiment, the blood collecting container housing table 98 has an inclination angle of +20 with respect to the horizontal state in the initial state.
The swinging means 42 is configured to swing with an amplitude of ± 20 ° with respect to the horizontal state. Then, in the initial state, that is, when the blood sampling container storage table 98 is at the position of + 20 °, the swinging means 42
Is almost at the top dead center, and the storage table 98 is-
When in the 20 ° position, the crank mechanism of the swinging means
It is set to be almost at the bottom dead center.

Further, it is preferable that a blood leak sensor (not shown) is attached to the lower surface of the blood collecting container storage chamber 41. This blood leak sensor is provided on a blood collection container storage table 98.
Is mounted on the storage base 98 such that the sensor section is exposed on the upper surface of the base. The blood leak sensor is configured, for example, by fixing a spacer on a load cell constituting a weight sensor and fixing a printed circuit board constituting the blood leak sensor thereon.

The blood sampling apparatus 1 has a control section 59 having an arithmetic circuit section such as a CPU. Control unit 5
9, during blood collection, calculates a blood change amount at regular intervals according to a signal from the blood volume detection means, and further calculates the blood change amount and the pressure reduction / pressure increase means 58 as shown in the flowchart of FIG. When the blood change amount is greater than or substantially equal to the set change amount, control is performed so as to increase the degree of pressure reduction of the pressure reducing / pressurizing means 58. As a result, the blood collection speed can be increased for a blood collector who can collect blood at a higher degree of reduced pressure, and the blood collection time can be reduced. When the blood change amount is smaller than the set change amount, the control unit 59 controls to reduce the degree of pressure reduction of the pressure reducing / pressurizing unit 58. As a result, safe blood collection can be performed without imposing a load on blood collectors with thin blood vessels and the like, and it is possible to cope with a decrease in blood flow during blood collection, thereby performing safe blood collection. it can.

More specifically, the control section 59 controls the weight detection section 5
Based on the signal from 7, every certain time (for example, 30 seconds)
Blood change amount calculation function to calculate the blood change amount
A set change amount storage function for storing a set change amount set in accordance with the degree of pressure reduction of the pressurizing / means 58; a comparison / judgment function for comparing and judging a blood change amount and a set change amount;
When it is determined by the determination function that the blood change amount is greater than or substantially equal to the set change amount, it is determined that the degree of decompression of the decompression / pressurization means 58 is increased, and that the blood change amount is smaller than the set change amount. In this case, a control function is provided for controlling the pressure reducing / pressurizing means 58 so as to reduce the degree of pressure reduction of the pressure reducing / pressurizing means 58. Further, the control unit 59 controls the pressure reduction /
The set minimum pressure reduction degree and the set maximum pressure reduction degree of the pressurizing means 58 are stored, and the pressure reduction degree of the pressure reducing / pressurizing means 58 is controlled within the range from the set minimum pressure reduction degree to the set maximum pressure reduction degree. Is preferred. Further, it is preferable that the control unit 59 has a decompression degree storage function of storing the decompression degree of the decompression / pressurization means 58 at least at the end of blood collection. Then, when continuously collecting blood from the same blood donor, the control unit 59 sets the initial decompression degree of the decompression / pressurization means 58 to the decompression degree stored at the end of the previous blood collection.
Preferably, it is controlled.

More specifically, the control unit 59 has a clock function, and determines the amount of change in blood for a certain period of time (for example, 30 seconds) based on a signal output from the blood collection container weight detection unit 57. And calculate. Specifically, the control unit 59 previously stores the weight of the blood collection container 5 before the start of blood collection, and sequentially determines the blood collection container 5 at regular time intervals based on signals output from the blood collection container weight detection unit 57. The weight of 5 is calculated. Then, the control unit 59 compares the weight of the previous blood collection container 5 with the weight of the current blood collection container 5 and determines the blood change amount (the weight of the current blood collection container 5-the weight of the previous blood collection container 5). Weight). That is, a fixed time (30 seconds in this embodiment)
Weight of blood in blood collection container 5 (blood change amount)
Is calculated. Furthermore, the blood change amount is compared with the set change amount. Control is performed to increase the degree of pressure reduction of the pressure means 58 by a predetermined value. If it is determined that the pressure is reduced, control is performed so as to reduce the degree of pressure reduction by a predetermined value. And
This determination operation is performed every predetermined time. In other words, after the determination is made once and the degree of pressure reduction is changed or maintained, the degree of pressure reduction is maintained for a certain period of time (for example, 30 seconds).

The set change amount is set according to the degree of decompression in consideration of the inner diameter and length of the lumen of the first blood vessel 2 and the viscosity of blood, and is stored in the control unit 59. The amount of change in the setting depends on the length and thickness of the blood supply vessel and the viscosity of the blood (changes depending on the temperature and the hematocrit value). In the case of the same device and the same blood property (blood viscosity), the amount of change is proportional to the degree of pressure reduction. Assuming that the device (including the blood collection tube) is constant and that the blood properties are within a certain range, the change amount =
It is expressed by the equation of degree of pressure reduction × k. Therefore, in this embodiment, k = 0.4. Thus, in this embodiment, the setting change amount is 40 ml / min when the degree of decompression is 100 mmHg, 20 ml / min when the degree of decompression is 50 mmHg, and 60 ml / min when the degree of decompression is 150 mmHg. When the degree of decompression is 200 mmHg per minute, it was set to 80 ml / min. However, the above k
Is not constant and varies depending on the length and thickness of the blood vessel used, and also varies depending on the blood properties. The set value of the degree of pressure reduction changed by the control unit 59 is 10 mmHg to 100 mm when increasing the degree of pressure reduction.
Hg, more preferably 10 mm
Hg to 50 mmHg.
It is preferably from 0 mmHg to 100 mmHg, and more preferably from 10 mmHg to 50 mmHg. As shown in FIG. 5, in the apparatus of this embodiment, four decompression degrees are set: a set minimum decompression degree, level 1, level 2, level 3, and a set maximum decompression degree. The interval between Level 1, Level 2, and Level 3 is 10 mmHg to 10
0 mmHg, preferably 30 to 70 mmHg,
In this example, the pressure was set to 50 mmHg. Therefore, in this embodiment, the set value of the pressure reduction degree to be changed (first set value)
Is also the difference in the degree of decompression between the levels.

As the blood volume detection means, a flow meter may be used instead of the blood collection container weight detection unit 57. In this case, the control unit 5 is controlled based on the output signal of the flow meter.
9 directly calculates the flow rate every fixed time (for example, 30 seconds).

Further, it is preferable that the control section 59 controls the degree of pressure reduction of the pressure reducing / pressurizing means 58 within the set minimum pressure reduction degree or the set maximum pressure reduction degree. This prevents the blood pressure from being controlled to a low decompression degree that cannot be collected, and prevents the decompression degree from becoming a dangerous high decompression degree for the blood sampler. The set minimum pressure reduction degree is preferably set to 10 mmHg to 100 mmHg, and more preferably 30 mmHg.
７０70 mmHg. In addition, the set maximum decompression degree is preferably set to 100 mmHg to 250 mmHg, more preferably 150 mmHg to 230 mmHg.
mmHg. Further, at the start of blood collection, the control unit 59 sets the decompression degree of the decompression / pressurization means 58 to a predetermined decompression degree (level 1 in FIG. 5) higher than the set minimum decompression degree and sufficiently lower than the set maximum decompression degree. It is preferable that the control be performed. Thus, blood collection is not performed at an excessively reduced degree of pressure from the beginning of blood collection, and safe blood collection can be performed even for blood collectors with narrow blood vessels. At the start of blood collection, the degree of pressure reduction of the pressure reducing / pressurizing means 58 is
Control may be performed so as to set the minimum pressure reduction degree.

The pressure reducing / pressurizing means 5 during blood collection
The degree of decompression 8 is controlled by the control unit 59, for example, as shown in the flowchart of FIG. That is, the control unit 59 first determines whether or not the timer in the control unit 59 is 0, and if it is 0, determines whether or not it is the first pressure reduction in the blood collection mode. And if it ’s the first decompression,
The vacuum pump 43 of the pressure reducing / pressurizing means 58 is operated to reduce the pressure to the above-described level 1 (here, 100 mmHg).
On the other hand, if it is not the first decompression, the change amount (blood change amount) of the blood collected in the blood collection container 5 is calculated based on the input signal from the blood collection container weight detection unit 57, and the blood change amount and the decompression amount are calculated. The set change amount set in accordance with the degree and stored in the control unit 59 (specifically, the set blood change amount at the current decompression degree) is compared. If the blood change amount is larger than the set change amount, the degree of pressure reduction is increased by a set value (here, 30 mmHg), and the degree of pressure reduction is increased to level 2. On the other hand, when the blood change amount is smaller than the set change amount, the degree of decompression is reduced by the set value (30 mmHg).
If it is level 2, lower it to level 1. Control unit 5
9 controls such control for a certain period of time (here, 30 seconds).
It is performed every time, and automatically adjusted to the degree of reduced pressure suitable for the blood collector. If the decompression degree is increased by the set value and exceeds the maximum set decompression degree, the maximum set decompression degree (here, 180 degrees) is set.
mmHg). Further, when the pressure reduction degree is reduced by the set value and becomes smaller than the minimum set pressure reduction degree, control is performed so as to be the minimum set pressure reduction degree. Then, 30 seconds are input to the timer, and this timer is reset to 0 again.
Is maintained at a controlled degree of pressure reduction until. Further, this control is repeatedly performed during blood collection.

It is more preferable that the control section 59 is controlled as shown in the flowchart of FIG. More specifically, if it is determined that the timer is 0, it is determined whether or not the pressure is the first pressure reduction. If the pressure is the first pressure reduction, the pressure is reduced to level 1 shown in FIG. Enter If it is not the first decompression, the blood change amount is compared with the set blood change amount, and it is determined whether the blood change amount is less than or equal to the set blood change amount.
If the blood change amount is equal to or greater than the set blood change amount, it is determined whether or not the previous change in the degree of decompression was an increase. If the previous time was the increase in the degree of pressure reduction, it is further determined whether or not the current degree of pressure reduction corresponds to any one of the levels 1, 2, and 3. If the current degree of pressure reduction is one of levels 1, 2, and 3, the degree of pressure reduction is increased to the next higher level (in other words, the degree of pressure reduction is increased by the first set value). In addition, if the previous pressure reduction degree was not the increase in the pressure reduction degree (in other words, if the previous time was the pressure reduction degree decrease) and if the current pressure reduction degree does not correspond to any of the levels 1, 2, and 3, the second Increase the degree of pressure reduction by the set value. This second set value is set to a value smaller than the first set value. Then, the decompression degree is compared with the set maximum decompression degree, and when the decompression degree is equal to or more than the set maximum decompression degree, the decompression degree is set to the maximum decompression degree, and when the decompression degree is less than the set maximum decompression degree, In this state, 30 seconds is input to the timer. When the blood change amount is smaller than the set blood change amount as a result of comparing the blood change amount and the set blood change amount, the degree of decompression is reduced to the closest level. Specifically, for example, if the current degree of pressure reduction is at level 3, the degree of pressure reduction is reduced to level 2. If the degree of pressure reduction is between level 1 and level 2, the degree of pressure reduction is reduced to level 1.
Therefore, the value at which the degree of pressure reduction decreases differs depending on the degree of pressure reduction when the degree of pressure reduction is to be lowered, and is not constant. Then, it is determined whether the degree of pressure reduction is greater than or equal to the set minimum pressure reduction degree. If the degree of pressure reduction is equal to or less than the set minimum pressure reduction degree, the state is maintained and 30 seconds are input to the timer.
If the degree of decompression is larger than the set minimum decompression degree, the second
Decrease the pressure reduction degree by the set value of.

When the degree of pressure reduction is decreased by the above flow, the degree of pressure reduction is compared with the set minimum degree of pressure reduction. If the degree of pressure reduction is larger than the set maximum degree of pressure reduction, 30 seconds is input to the timer in that state.
By performing such control, it is possible to more accurately control the degree of pressure reduction. In this control, as shown in FIG. 5, when the degree of decompression is increased to level 3, the blood change amount becomes smaller than the set blood change amount. Is assumed to exist. Then, after the pressure reduction degree is once reduced to level 2, the pressure reduction degree is gradually increased by the second set value (smaller than the first set value). And if there is an appropriate flow rate between level 2 and level 3,
In addition, the blood change amount becomes smaller than the set blood change amount, and the degree of decompression is reduced to level 2, and this is repeated. Also, once the degree of decompression has been reduced, the blood vessel may be recovered by gradually increasing by the second set value,
In this case, it is also possible to perform blood collection at level 3 and at the set maximum decompression degree. Note that the first set value when increasing the degree of pressure reduction is preferably the above-described set value, and the second set value is 5 mmHg to 50 mm
Hg, more preferably 10 mm
Hg to 30 mmHg.

Further, the control section 59 stores the degree of decompression at which the blood change amount and the set change amount become substantially equal (specifically, the degree of decompression near the end of blood collection).
It is preferable to control the pressure reducing / pressurizing means 58 to start blood collection at the stored pressure reduction degree. Thus, in a plasma collection device that performs a plurality of blood collection operations when collecting plasma, blood can be collected at an appropriate degree of reduced pressure from the start of blood collection. Then, when decreasing the degree of pressure reduction, for example, when descending from level 3 to level 2,
It is preferred that cuff pressurization be stopped and released to atmospheric pressure. Therefore, it is preferable that the control unit 59 has a function of judging when the degree of pressure reduction is decreased, and controlling the pressure to be released to the atmospheric pressure.

The control section 59 is provided with the slit detecting means 6.
7 detects the first slit of the oscillating means 42, the electric circuit of the oscillating motor is turned off, so that the rotation of the oscillating motor of the oscillating means 42 is reduced to near the top dead center of the crank mechanism (almost). , Top dead center). Further, after stopping the rotation of the rocking motor, the control unit 59 controls the blood collection container weight detection unit 57 to detect the whole blood weight. Thus, the blood collection device 1 can stop the blood collection container housing 98 at a predetermined position, detect the weight of whole blood, and perform more accurate weight measurement. The reason why the detection is performed by stopping the storage table 98 is that accurate detection is difficult due to the influence of inertia due to the gravity of the weighing object during swinging. This is because the load applied to the container weight detector 57 changes.

Further, when the slit detecting means 67 detects the second slit, the control section 59 turns off the electric circuit section of the oscillating motor, thereby controlling the rotation of the oscillating motor at the bottom dead center of the crank mechanism. Control is performed to stop near (substantially bottom dead center). Thereby, the blood collection container storage table 9
8, the tube connection side of the blood collection container 5 can be stopped at a position of + 20 ° above the horizontal, and the air in the blood collection container 5 is moved to the tube connection side and mixed into the container 5. The air can be sufficiently removed. Further, when the slit detecting means 67 detects the first slit, the control section 59 can operate the blood collection container weight detecting section 57 without stopping the rocking motor to control to detect the whole blood weight. It is preferred that Thus, although the accuracy is inferior to the case where the weight is detected by stopping the storage table 98, it is possible to detect the weight of the whole blood that changes sequentially while swinging.

Further, in the blood collection container storage chamber 41, FIG.
As shown in the figure, a pressure detecting means 55 for detecting the pressure inside the storage chamber 41, for example, a pressure sensor is attached. Specifically, the pressure detecting means 55 is attached so as to communicate with the blood collection container storage chamber 41 via a tube. As the pressure detecting means 55, a diffusion type semiconductor pressure detecting means is preferably used.

The circuit switching means 12, 13, 14,
Reference numeral 46 denotes a solenoid pinch valve which is normally closed. Further, as shown in FIG. 2, an ACD bag hanger 85 is provided on the left side surface of the blood sampling device 1. In addition, the blood collection device 1
A plasma separator holder 84 forming a plasma separator mounting portion is provided on the front surface of the plasma separator. This plasma separator holder 84 has a front about 2 mm below about 30 mm from the center.
The plasma separator can be mounted at an angle of 0 °, and the mounted state can be held and released by a latch-type magnet catch. Further, a cuff pressurizing port 93 is provided on the entire surface of the blood sampling device 1, and a tube connected to the cuff 49 can be attached as shown in FIG. The cuff pressurizing port 93 is connected to a cuff pressure pump (pressurizing pump) 44 provided in the blood collection device 1.
Further, a pressure sensor for detecting the pressure inside the port 93
(Pressure detecting unit) 56 and a leak valve 54 are attached. As the cuff pressurizing pump 44, a small-sized pump for a sphygmomanometer can be preferably used, and as the pressure sensor 56, a diffusion type semiconductor pressure sensor can be preferably used. The pressure applied to the cuff 49 from the cuff pressurizing port 93 can be set at +10 to +100 mmHg every 10 mmHg. This set pressure can be input from the front panel 80 shown in FIG. Further, as shown in FIG. 1, the blood sampling apparatus 1 has a bubble detecting means 9 for detecting bubbles in the third blood supply vessel.
7 is provided. An ultrasonic bubble sensor can be suitably used as the bubble detecting means.

As shown in FIG. 2, the blood collecting apparatus 1 is provided with a plasma weight detecting section 99 for detecting the weight of the plasma collecting container 10. An electronic balance with an external output is preferably used.
Is measured at regular intervals, and the measured data is
It is input to the control unit 59.

[0035]

Next, the operation of the blood sampling apparatus 1 according to the present invention will be described with reference to FIGS. In particular, a blood collection circuit having a blood collection needle 21, a blood collection container 5, a first blood supply vessel 2 communicating the blood collection needle 21 with the blood collection container 5, as a plasma collection circuit, and a blood collection circuit for collecting whole blood. Anticoagulant addition circuit for adding a coagulant, plasma separation means for separating whole blood to which the anticoagulant is added into a plasma component and a blood cell component,
A blood collection device for controlling a plasma separation circuit having at least a blood cell collection container for collecting the separated blood plasma component and a blood cell component return circuit for returning the separated blood cell component to a blood collector, and comprising: The collection device 1 includes a blood collection container storage chamber 41, a decompression / pressurization unit 58 for pressurizing and depressurizing the inside of the blood collection container storage chamber 41, and a blood collection container storage table 98 of the blood collection container storage chamber 41. Swinging means 42 for swinging, a blood sampling container weight detecting unit 57 for detecting the weight of the blood sampling container, and first to third means provided on the disk of the swinging unit of the swinging means 42. It has a slit detecting means 67 for detecting a slit, a plasma separator mounting portion to which the plasma separator 7 is detachably attached, and a control portion 59, and is provided inside the blood collection container 5 from the anticoagulant storage container 45. Injected a fixed amount of anticoagulant After the air bleeding / anticoagulant inflow step for injecting the anticoagulant into the first blood supply vessel 2 together with the air inside the blood collection container 5, and after the air bleeding and the anticoagulant inflow step, pressure reduction / pressurization is performed. An anticoagulant injecting step of injecting a predetermined amount of an anticoagulant from the anticoagulant container 45 into the blood collection container 5 by operating the means 58 to reduce the pressure inside the blood collection container storage chamber 41 and into the blood collection container 5; After the agent injecting step is completed, the depressurizing / pressurizing means 58 is operated to put the inside of the blood collecting container storage chamber 41 into a reduced pressure state, and a predetermined amount of blood is collected from the donor into the blood collecting container 5. After the blood collection step is completed, the decompression / pressurization means 58 is operated to put the inside of the blood collection container storage chamber 41 into a pressurized state, and the blood in the first blood supply vessel 2 is returned to the donor, and Blood collection during blood supply 2 After the small blood return step in which the collected blood flows into the inside of the blood vessel 5 and the small blood return step are completed, the decompression / pressurization means 58 is operated to pressurize the inside of the blood collection container storage chamber 41 to collect blood. The blood collected inside the container 5 flows into the plasma separator 7, and the plasma component flowing out from the plasma outlet of the plasma separator 7 is collected in the plasma collection container 10, and the blood cell outlet of the plasma separator 7 is collected. Separation to return blood cell components flowing out to the donor
A blood return step is performed.

The blood collection needle 2 is used as a plasma collection circuit.
1, a blood collection container 5, a first blood supply vessel 2 that connects the blood collection needle 21 and the blood collection container 5, a plasma separator 7, and a blood inlet of the blood collection container 5 and the plasma separator 7. A second blood vessel 6, a third blood vessel 8 communicating the blood outlet of the plasma separator 7 with the first blood vessel 2, a plasma collection container 10, a plasma outlet of the plasma separator 7, and plasma A single-needle type plasma having a plasma transport tube 9 communicating with the collection container 10, an anticoagulant storage container 45, and an anticoagulant transport tube 48 communicating the anticoagulant storage container 45 and the blood collection container 5. Separation circuits are preferably used. In addition, the blood collection device 1 includes a first circuit opening / closing unit 12 for opening / closing the first blood vessel 2 of the plasma separation circuit, and a second circuit opening / closing means for opening / closing the second blood vessel 6 or the third blood vessel 8. Circuit opening / closing means 13, third circuit opening / closing means 14 for opening / closing plasma transport tube 9, fourth circuit opening / closing means 46 for opening / closing anticoagulant transport tube 48, and weight of plasma collection container It has a detection unit 99.

The blood collection apparatus 1 repeats the anticoagulant injection step, the blood collection step, the small-volume blood return step, and the separation / blood return step in this order by repeating a set number of times. The steps and the progress of the steps are substantially automated by the control unit 59. Further, the air bleeding / anticoagulant inflow step is performed only for the first time.

In particular, with reference to FIG. 3 to FIG. 17, a case where blood plasma is collected five times using a blood collection container 5 for 200 ml will be described as an example. First, as shown in FIG. 6, when the power switch of the blood collection device 1 is turned on, the CPU of the control unit 59 is initialized as an initialization, and then the electrical abnormality of each unit is automatically checked. . Subsequently, the blood collection volume (200 ml or 400 m
l, setting of 200 ml in this explanation, setting of processing mode [only blood collection or apheresis (plasma collection), setting of apheresis in this explanation], setting of the number of times of blood collection (5 times in this explanation), and setting parameters Is transferred to the RAM. Further, if necessary, parameters such as blood collection pressure and blood return pressure are changed using a parameter setting switch provided on the front surface of the blood collection device 1. Note that, in this state, the blood collection container housing 98 is stopped at a position of + 20 ° with respect to the horizontal so that the tube connection side of the blood collection container 5 is lowered.

When the lid 83 is opened, the circuit opening / closing means 1
2 (CL12), 13 (CL13), 14 (CL1
4) and 46 (CL46) are open. The leak valve 50 (LV50) of the pressure reducing / pressurizing means 58 is open, and both the pressure reducing / pressurizing switching valves 51 (V51) and 52 (V52) of the pressure reducing / pressurizing means 58 are open to the atmosphere. I have. Then, the weight of the blood collection container housing table 98 is detected and stored as TWO. Subsequently, when there is no error in the setting of the blood collection container 5, a blood collection volume of 200 ml, the number of blood collections (Ns) = 5, and a processing mode (apheresis) are input as an initial value set. Then, a tube connected to the cuff 49 is attached to the cuff pressurizing port 93, and the cuff 49 is attached to the blood donor.

When the start switch on the front panel is turned on after the above setting is completed, the process shifts to [3] in the flowchart of FIG. Then, the weight of the blood collection container 5 is detected (TW5), and TW5 is slightly (ΔTW0) larger than TW0 (the weight of the storage table 98) TW0 + ΔTW.
In the case of 0 or less (TW0 + △ TW0 ≧ TW5), it is detected that the blood collection container 5 is not stored in the blood collection container storage chamber 41, the alarm 82 is activated, and the process proceeds to the mounting process routine. Also, if blood leaks or the lid is open, the alarm 82
Operates.

When these operations are completed, the start lamp is turned on, and the mode shifts to the air bleeding / anticoagulant injection mode.
Ns (N = 5 in this case) is input, and detection of the pressure (BP) of the blood collection container storage chamber 41 is started. Then, the process proceeds to [5] in the flowchart in FIG. 8 and further to [10] in the flowchart in FIG. Then, the pressure reducing / pressurizing means 58 is operated to put the inside of the blood collection container storage chamber 41 into a reduced pressure state, and the anticoagulant storage container 45 is placed inside the blood collection container 5.
After injecting a predetermined amount of the anticoagulant, an air bleeding / anticoagulant inflow step of removing the air inside the blood collection container 5 and allowing the anticoagulant to flow into the first blood vessel 2 is performed. . When the swing means 42 operates and the slit detection means 67 detects the second slit, the swing motor stops at the bottom dead center of the crank mechanism, and the swing means 42 is turned off. Accordingly, the blood collection container housing table 98 is positioned at a position where the tube connection side of the blood collection container 5 is at the top (in this embodiment,
(At a position of −20 ° with respect to the horizontal). More specifically, in this operation, the rocking motor and the disk attached to the shaft of the rocking motor rotate with the operation of the rocking means 42, and the slit detecting means 67 turns the second disk of the disk.
And the control unit 59 controls the rotation of the swing motor to stop at the bottom dead center of the crank mechanism, whereby the air in the blood collection container 5 is connected to the tube connection. Move to the side. Then, when the blood collection container housing table 98 stops at the above position, the leak valve 5
0 is closed, valve 51 is open to atmosphere, valve 52
Is in a ventilated state, the vacuum pump 43 is operated, the inside of the blood collection container storage chamber 41 is pressurized, the circuit opening / closing means 12 is opened, and the air moved to the tube connection side of the blood collection container 5 is supplied to the first blood supply vessel. The blood is discharged from the blood collection needle 21 through the outside 2. Further, the leak valve 50 is opened to the atmosphere, the pump 43 is turned off, and the circuit
Is closed, and the first air release ends.

Further, an anticoagulant lamp (ACD lamp)
Lights up, the swinging means 42 operates, and the slit detecting means 6
When 7 detects the first slit, the swing motor stops at the top dead center of the crank mechanism, and the swing means 42 is turned off. Thereby, the blood collection container housing table 98 is in the initial position (the position where the tube connection side of the blood collection container 5 is lowered, in this embodiment, + 20 ° with respect to the horizontal).
Return to More specifically, in this operation, the rocking motor and the disk attached to the shaft of the rocking motor rotate with the operation of the rocking means 42, and the slit detecting means 67
Detects the first slit of the disk and controls the control unit 59 to stop the rotation of the swing motor at the top dead center of the crank mechanism.

When the blood collecting container housing table 98 is stopped at the initial position, the leak valve 50 is closed, the valve 51 is ventilated, the valve 52 is opened to the atmosphere, the vacuum pump 43 is operated, and the blood collecting container is stopped. The pressure inside the container storage chamber 41 is reduced. Further, the circuit opening / closing means 46 is opened, and a small amount (here, 10 ml) of an anticoagulant (for example, ACD) is put into the blood collection container 5 from the anticoagulant container 45.
Liquid) is injected. The injection of the anticoagulant is performed by the blood collection container weight detection unit 57 by the weight (NWn) of the blood collection container 5.
Thus, the weight obtained by subtracting the weight (NW0) before filling with the anticoagulant is performed until it is detected that the weight of the anticoagulant reaches the set weight (W5, here, 10 ml) or more (NWn-NW0 ≧ W5). Is reached, the leak valve 50 is opened to the atmosphere, the vacuum pump 43 (VP43) is turned off, the circuit opening / closing means 46 is closed, and the anticoagulant injection operation is completed. Note that NWn-N
Until W0 ≧ W5, it is always determined whether an abnormality has occurred. If an abnormality has occurred, an abnormality process is performed.

When the injection of the anticoagulant is completed, the oscillating means 42 operates again, and when the slit detecting means 67 detects the second slit, the oscillating motor 60 stops at the bottom dead center of the crank mechanism. Then, the rocking means 42 is turned off. Accordingly, the blood collection container housing table 98 is positioned at a position where the tube connection side of the blood collection container 5 is at the top (in this embodiment,
(At a position of −20 ° with respect to the horizontal). When the storage table 98 stops, the leak valve 50 is closed, the valve 51 is opened, the valve 52 is vented, the vacuum pump 43 is operated, and the blood collection container storage chamber 41 is operated.
The inside is pressurized. Further, when the circuit opening / closing means 12 is opened, the residual air in the blood collection container 5
Through the blood collection needle 21 through the
The blood vessel is filled with an anticoagulant. During that time, the blood collection container weight detection unit 57 sequentially detects the weight (NWn) of the blood collection container 5, and the NWn is the weight (NWn) before the anticoagulant is filled.
0) NW0 + △ NW slightly larger than (△ NW0)
0 or less (NWn ≦ NW0 + △ NW0), the leak valve 50 is open to the atmosphere, and the vacuum pump 43 (VP4
3) is turned off, the circuit opening / closing means 46 is closed, and the second air bleeding operation is completed. Note that while NWn> NW0, it is always determined whether or not an abnormality has occurred, and if an abnormality has occurred, abnormality processing is performed. Furthermore, we perform air bleeding work twice,
Further, the inflow step (mode) of the anticoagulant into the first blood vessel 2 is completed, and the process proceeds to the anticoagulant injection step (mode).

When the air bleeding operation in the blood collection container 5 is completed, the processing mode, in this case, the apheresis is determined, and the flow shifts to [6] in the flowchart shown in FIG. 10, and the leak valve 50 is closed. The pressure reduction / pressure switching valve 51 is ventilated, the circuit opening / closing means 46 is opened, the vacuum pump 43 is operated, and the inside of the blood collection container storage chamber 41 is depressurized, and the blood collection from the anticoagulant storage container 45 is performed. An anticoagulant (here, 20
ml) is injected. The anticoagulant is injected by the blood collection container weight detection unit 57 and the control unit 59 from the weight (NWn) of the blood collection container 5 before the anticoagulant is filled.
0) is subtracted from the set weight (W0) of the anticoagulant or more (NWn−NW0 ≧ W0) until the above state is reached. When the above state is reached, the vacuum pump 43 (V
P43) stops operating, and the circuit opening / closing means 46
Is closed, the leak valve 50 is opened, and the operation of injecting the anticoagulant ends. If NWn−NW0 ≧ W0 is not reached within a predetermined time, it is always determined whether or not an abnormality has occurred. If an abnormality has occurred, abnormality processing is performed. Subsequently, the cuff pressure (CPR) is detected, the leak valve 54 is closed, and the cuff pressurizing pump 44 (CP4
4) operates. When the cuff pressure becomes higher than the set value (P2) (CPR ≧ P2), the standby alarm is activated, the ACD lamp is turned off, and the start lamp blinks. If CPR ≧ P2 is not reached within a predetermined time, it is always determined whether or not the cuff pressure is abnormal. If an abnormality occurs, abnormal processing is performed, and the process proceeds to [7] in the flowchart. Then, the mode shifts to the blood collection mode.

Then, the blood collection needle 21 is punctured into the vein of the blood donor, and after confirming that the blood has flowed into the blood supply tube from the blood collection needle by the blood pressure of the blood donor, the start switch provided on the front panel 80 is turned on. turn on. As a result, the process shifts to the flowchart [8] shown in FIG. 11, and the cuff pressurizing pump 44 maintains the operating state and is maintained within the predetermined pressure range. By the operation of the vacuum pump 43, blood flows into the blood collection container 5, and the rocking means 42 operates.
Further, the blood collection lamp and the start lamp are turned on. The oscillating means 42 oscillates the storage table 98 at a constant cycle (in this embodiment, about 1 second cycle). During the oscillating operation, the blood collection container weight detector 57 detects the initial position (storage table). Is + 20 ° with respect to the horizontal), and the whole blood weight is sequentially detected. This is because, when the slit detecting means 67 detects the first slit, the control section 59 operates the blood collection container weight detecting section 57 without stopping the rotation of the swing motor,
By controlling to detect the weight of whole blood while oscillating.

Further, the control section 59 is controlled as shown in the flowchart of FIG. If it is determined that the timer is 0, it is determined whether or not it is the first pressure reduction. If it is the first pressure reduction, the pressure is reduced to level 1 shown in FIG. 5 and 30 seconds are input to the timer. If it is not the first decompression, the blood change amount is compared with the set blood change amount, and it is determined whether the blood change amount is less than or equal to the set blood change amount. If the blood change amount is equal to or greater than the set blood change amount, it is determined whether or not the previous time was an increase in the degree of decompression. If the previous time was the increase in the degree of pressure reduction, it is further determined whether or not the current degree of pressure reduction corresponds to any one of the levels 1, 2, and 3. And the current degree of decompression is
If the level is one of levels 1, 2, and 3, the degree of pressure reduction is increased to the level one level higher (in other words, the degree of pressure reduction is increased by the first set value). In addition, when the previous depressurization degree was not the increase (in other words, when the previous time was the depressurization degree decrease), and the current decompression degree is the level 1, 2, 3
If none of the above applies, the degree of pressure reduction is increased by the second set value. This second set value is set to a value smaller than the first set value. Then, the decompression degree is compared with the set maximum decompression degree, and when the decompression degree is equal to or more than the set maximum decompression degree, the decompression degree is set to the maximum decompression degree, and when the decompression degree is less than the set maximum decompression degree, In this state, 30 seconds is input to the timer. When the blood change amount is smaller than the set blood change amount as a result of comparing the blood change amount and the set blood change amount, the degree of decompression is reduced to the closest level. Specifically, for example, if the current degree of pressure reduction is at level 3, the degree of pressure reduction is reduced to level 2. If the degree of pressure reduction is between level 1 and level 2, the degree of pressure reduction is reduced to level 1.
If the degree of pressure reduction is lower than the level 1 and greater than the set minimum pressure reduction degree, the pressure is reduced to the set minimum pressure reduction degree.

Then, the degree of decompression is reduced by the above flow, and when the degree of decompression is lower than the set minimum decompression degree (corresponding to the case where the current decompression degree is the set minimum decompression degree). Sets the pressure reduction degree to the set minimum pressure reduction degree, and inputs 30 seconds to the timer in this state. By performing such control, it is possible to more accurately control the degree of pressure reduction. Further, the control unit 59 stores the decompression degree at which the blood change amount and the set change amount are substantially equal (specifically, the decompression degree near the end of blood collection), and stores the stored decompression degree at the start of the next blood collection. The decompression / pressurization means 58
Starts collecting blood. Then, when decreasing the degree of pressure reduction, for example, when descending from level 3 to level 2,
Stop cuff pressurization and release to atmospheric pressure.

The control of the degree of pressure reduction by the control means 59 will be described more specifically with reference to the time chart of FIG. FIG. 5 is a time chart showing an example of controlling the degree of pressure reduction. In the control example of FIG. 5, first, the control unit 59 controls the degree of pressure reduction of the pressure reducing / pressurizing unit 58 to be level 1. Then, in judgment 1 after a certain time (after 30 seconds), the blood change amount is compared with the set change amount, and since the blood change amount is larger than the set change amount, the degree of decompression is set to the first set value (50 mm).
Hg) to level 2. Further, in the determination 2 after a certain period of time, since the blood change amount is larger than the set change amount, the degree of decompression is set to the first set value (50 mmHg).
Increase the degree of pressure reduction to level 3. Then, in judgment 3 after a certain period of time, since the blood change amount is smaller than the set change amount, it is assumed that an appropriate flow rate exists between level 2 and level 3, and the pressure reduction degree is once reduced to level 2. Let it. Then, in the judgment 4, since the degree of decompression is reduced by the first set value in the judgment 3, the degree of decompression is level 2. In this state, since the blood change amount is larger than the set change amount, the first setting The second set value (10 m
mHg). Further, in the judgments 5 and 6, the blood change amount is larger than the set change amount.
The decompression degree is increased by the set value of. If the degree of decompression continues to increase and the blood change amount is still larger than the set change amount even when the decompression degree reaches level 3, the decompression degree is raised by one level (in this case, the set maximum decompression degree). Until it rises. If an appropriate flow rate exists between level 2 and level 3, as shown in decision 7, the blood change amount is less than the set blood change amount, and in this case, the next lower level (in this case, , Level 2), the degree of decompression is reduced, and this is repeated. As described above, the blood collection apparatus of the present invention performs depressurization /
This is for automatically adjusting the degree of pressure reduction of the pressurizing means 58 to a more appropriate degree of pressure reduction.

Then, blood sampling is performed as described above,
The whole blood weight is -50 ml of the set blood collection volume (here, 150
ml), the swing is stopped (about 1 second) at the position of the initial state, and more accurate weight detection is performed. further,
The weight (NWn) of the blood collection container 5 is equal to or greater than a set weight [W1 = set blood collection weight + anticoagulant weight (W0)] (NWn ≧ W
When reaching 1), the circuit opening / closing means 12 is closed, the leak valve 50 is opened, the operations of the vacuum pump 43 and the cuff pressurizing pump 44 are stopped, the valve 51 is also opened to the atmosphere, and the blood sampling operation is completed. . Further, thereafter, in order to sufficiently collect the blood and the anticoagulant, the rocking means 42 continues to operate, and after performing stirring several times continuously, the blood collection lamp is turned off, and the rocking means 42 It turns off. Also,
Unless NWn ≧ W1 within a predetermined time, it is always determined whether or not an abnormality has occurred. If an abnormality has occurred, abnormality processing is performed. Then, the processing mode (only blood collection or apheresis, in this case, apheresis) is determined, and the flow shifts to [9] in the flowchart shown in FIG.

From here, the mode is shifted to the small blood return mode, and the separation blood return lamp is turned on. In the small-volume blood return mode, the blood in the first blood supply vessel 2 is in a state in which the anticoagulant has not been added after the blood collection, and if left as it is, the blood in the first blood supply blood vessel 2 will coagulate. By returning a small amount of blood, the blood in the first blood vessel 2 is returned to the donor,
This is performed in order to prevent blood from coagulating in the blood supply vessel 2 by flowing blood into which the anticoagulant in the blood collection container 5 has flowed into the blood supply vessel 2. In the small-volume blood return mode, the leak valve 50 is closed, the valve 51 is open to the atmosphere, the valve 52 is vented, the vacuum pump 43 operates,
The inside of the blood collection container storage chamber 41 is pressurized, the weight of the blood collection container 5 at this time is stored as TW3, and the circuit opening / closing means 12 is set in the open state. The weight of this small amount of blood returned is the weight obtained by subtracting the weight (NWn) of the blood collection container 5 from the weight (TW3) of the blood collection container 5 before blood return [set weight of blood returned with anticoagulant added blood (W2)]. The above operation is performed until (TW3-NWn ≧ W2), and when the set weight is reached, the operation of returning a small amount of blood is completed, the mode is shifted to the separation / blood return mode, the circuit opening / closing means 12 is closed, and the circuit opening / closing operation is performed. The means 13 is opened. Unless TW3−NWn ≧ W2 within a predetermined time, it is always determined whether or not an abnormality has occurred. If an abnormality has occurred, an abnormality process is performed. Then, the number of remaining blood collection times (N) is determined, and N = Ns (in this case, N =
5) In other words, if it is determined that this is the first time, the circuit opening / closing means 14 is slightly delayed to be in the open state. this is,
In order to prevent the plasma from being diluted by the priming solution (physiological saline) filled in the plasma separator 7 only for the first time, the opening timing of the circuit opening / closing means 14 is set to 10 to
This is because only the priming solution (physiological saline) flows out with a delay of 20 seconds. In the separation / blood return mode, the circuit opening / closing means 13 and 14 are open, and the operation of the vacuum pump 43 is maintained. Therefore, the blood inside the blood collection container 5 flows into the plasma separator 7, and the plasma component separated by the plasma separator 7 passes through the plasma transport pipe 9 and the plasma collection container 10.
Flows into. The blood cell component flowing out of the plasma separator 7 passes through the third blood supply vessel 8 and is returned to the donor.

The weight of the plasma collection container 10 is weighed by the plasma weight detection unit 99 at regular intervals.
Then, in this operation, when the weight of the plasma collection container 10 does not reach the set plasma collection amount, the blood collection container 5 has a set threshold value, in other words, the weight of the blood collection container 5 (NWn). Weight of blood collection container 5 before blood collection (TW5)
Is less than or equal to the set weight (Wth) (NWn-T
W5 ≦ Wth), the next blood collection amount is calculated from the collected blood plasma collection weight and the blood collection amount, and the next blood collection amount is calculated as follows. Plasma collection efficiency (η) = Current plasma collection amount / Set blood collection amount ... (1) Remaining plasma collection amount = Set plasma collection amount-Integrated value of plasma collection amount ... (2) Next forecast Plasma collection volume = set blood collection volume x η ... (3) When remaining plasma collection volume ≥ next expected plasma collection volume Next blood collection volume = set blood collection volume ... (4) Remaining plasma collection volume <In the case of the next expected plasma collection volume Next collection volume = remaining plasma collection volume / η + α (5) (where α is due to an increase in the blood hematocrit value of the donor and a decrease in the performance of the plasma separator 7) The amount is set in consideration of the decrease in plasma collection efficiency, and is usually 10 to 30
The value is about g. )

When the weight of the plasma collection container 10 reaches the set plasma collection amount, the circuit opening / closing means 13 and 14 are closed, the valves 51 and 52 are open to the atmosphere, and the operation of the vacuum pump 43 is stopped. , The separation and blood return work is completed,
The process proceeds to the flowchart [11] in FIG. In addition, within a predetermined time, while the weight of the plasma collection container 10 does not reach the set plasma collection amount, it is determined whether an abnormality has occurred,
If an error occurs, perform error processing. Then, it is determined whether the remaining number of blood collection times is one (N: 1), and if not, the process proceeds to [12] in the flowchart shown in FIG. 14 and N = N−1 is input. Is performed, and the weight of the blood collection container 5 is stored as TW1. In this description, the embodiment in which the number of times is input is used. However, the number of times may not be input in consideration of the above-mentioned amount of collected plasma. Again, the ACD lamp lights up,
Leak valve 50 is closed, valve 51 is vented,
The valve 52 is opened to the atmosphere, the vacuum pump 43 is operated, the circuit opening / closing means 46 is opened, the leak valve 54 is closed, the cuff pressure pump 44 is operated, and blood is collected from the anticoagulant container 45. An anticoagulant (for example, an ACD solution) is placed in the blood collection container 5 and the weight (NW
n) minus TW1 is the set weight of anticoagulant (W
o) Injection is performed until (NWn-TW1 ≧ Wo) or more, and when the above set weight is reached, the circuit opening / closing means 46 is closed, the operation of the vacuum pump 43 is stopped, and the ACD
The lamp goes off. Also, within a predetermined time, NWn-TW
Until 1 ≧ Wo, it is always determined whether or not an abnormality has occurred. If an abnormality has occurred, abnormality processing is performed. When the cuff pressure becomes higher than the set value (CPRn ≧
P2), the flow shifts to [13] in the flowchart shown in FIG. 11, and blood collection is started again. Also, within a predetermined time, C
Until PRn ≧ P2, it is always determined whether or not an abnormality has occurred. If an abnormality has occurred, an abnormality process is performed.

When it is determined that the number of remaining blood collections is one (N = 1), an end alarm sounds, the start lamp and the separated blood return lamp are turned off, the end lamp is turned on, and the blood donation is performed. The blood sampling needle 21 is removed from the person. And
When the lid of the blood collection device 1 is opened, all of the circuit opening / closing means 12, 13, 14, and 46 are opened, the end lamp is turned off, the blood collection container 5 is taken out of the blood collection container storage chamber 41, and the plasma The plasma separator 7 is removed from the separator mounting portion, and the plasma collection operation is completed. If necessary, the number (N) is input from the number key without opening the cover, and the start key is pressed again. Then, the processing shifts to [14] in the flowchart of FIG. Transition.

In the blood sampling apparatus 1 of this embodiment, when an abnormality occurs in the detection of the weight and the cuff pressure of the blood collection container 5, the abnormality is detected and an abnormality process is performed. Next, an abnormality processing flow of the blood sampling apparatus 1 of the present invention will be described with reference to FIGS. In this abnormal processing flow, as shown in the route on the left side of FIG. 15 at all times, during the operation of the blood collection device 1, whether or not the stop switch has been pressed, whether or not the blood collection flow rate has decreased,
It is sequentially determined whether or not the lid is open, whether or not there is blood leakage, and whether or not air bubbles are detected during the plasma separation and blood return modes. 20]. First, when a decrease in the blood collection flow rate is detected, it is determined whether it is during blood collection, and if so, A = 1 (if A = 1, it means that the blood collection flow rate has decreased again). Judge, A =
If it is not 1, the process proceeds to subroutine A shown in FIG. In this blood collection device 1, the blood collection container storage chamber 4
(1) The pressure is maintained within the above range by repeating ON / OFF of the vacuum pump so that the internal pressure has a set pressure as an upper limit and a predetermined lower limit (for example, 0.9 times the set pressure) as a lower limit. It is controlled so that.

Further, the weight detection by the blood collection container weight detecting section 57 provided in the blood collection container storage chamber 41 is performed for each swing cycle of the swinging means 42 of the blood collection container storage chamber 41, and , Is configured to detect a decrease in blood collection flow rate by comparing with a previously detected weight.
When the decrease in the blood collection flow rate is detected, the process proceeds to the subroutine A shown in FIG. 16 as described above. And
The leak valve 50 is opened, and this state is maintained for one second (T4). Then, the blood collection pressure (P) is automatically set to 1/2 of the set pressure (P1), that is, P1 / 2, the leak valve 50 is closed, and A = 1 is automatically input,
Start blood collection again. Then, when the blood collection flow rate decreases again, A = 1 is determined as shown in the flowchart of FIG. 15. Then, A = 0 is automatically input, an alarm is activated, and the flow shifts to [20] in the flowchart of FIG. 17, and as shown in FIG. 50 and the leak valve 54 are opened, then all the circuit opening / closing means are closed, the start switch blinks, and the interruption switch blinks.

Subsequently, ON / OFF of the start switch and ON / OFF of the interruption switch are determined. When the start switch ON and the closing of the lid 83 are detected, the interruption lamp is turned off, the start lamp is turned on, the alarm lamp is turned off, and the flow shifts to the flowchart [21] of FIG. When the interruption switch is confirmed to be ON, the alarm lamp, the start lamp, and the interruption lamp are turned off, and the process shifts to [2] in the flowchart of FIG. 6 to stop the plasma sampling operation.

[0058]

The blood collection apparatus of the present invention has a blood collection needle, a blood collection container, and a blood supply tube communicating with the blood collection needle and the blood collection container, and controls a blood collection circuit for collecting blood from a blood collector. A blood collection device for storing the blood collection container of the blood collection circuit, a decompression means for decompressing the inside of the storage chamber, and a blood collection device. A blood volume detecting means for detecting the amount of blood collected in the container; and a control unit for controlling the decompression means and the blood volume detecting means, wherein the control unit detects the blood volume during blood collection. Based on an output signal from the means, a blood change amount is calculated for each fixed time, and further, the blood change amount is compared with a set change amount set according to the degree of decompression of the decompression means, and the blood change amount is calculated. Is greater than or approximately equal to the set change, The degree of decompression of the decompression means is increased, and when the blood change amount is smaller than the set change amount, control is performed so as to decrease the decompression degree of the decompression means, and the decompression degree suitable for the blood collector is automatically adjusted. Therefore, blood collection efficiency is high and blood collection can be performed in a short time, and blood collection can be performed safely.

The blood plasma collecting apparatus of the present invention has a blood collecting container and has a blood collecting circuit for collecting whole blood from a blood collector.
An anticoagulant addition circuit for adding a blood anticoagulant to the collected whole blood, a plasma separation circuit for separating the anticoagulant-added whole blood into a plasma component and a blood component, and a separated plasma component A plasma collection circuit for controlling a plasma collection circuit having at least a blood cell component return circuit for returning a separated blood cell component to a blood sampler, the plasma collection device comprising: A blood collection container storage chamber for storing the blood collection container of the blood collection circuit, a pressure reducing / pressurizing means for reducing or increasing the pressure inside the storage chamber, and detecting an amount of blood collected in the blood collection container; For blood volume detection means, and has a control unit for controlling the decompression / pressurization means and the blood volume detection means, the control unit, during blood collection, based on the output signal from the blood volume detection means, Calculate the blood change amount for each fixed time Further, the set change amount set in accordance with the degree of decompression of the decompression / pressurization means is compared with the blood change amount, and if the blood change amount is larger than or substantially equal to the set change amount, Increase the degree of decompression of the pressurizing means,
When the blood change amount is smaller than the set change amount, since it is to control to reduce the degree of decompression of the decompression / pressurization means, it is to automatically adjust the degree of decompression suitable for the blood collector, Blood collection efficiency is high and blood collection can be performed in a short time, and blood collection can be performed safely.

[Brief description of the drawings]

FIG. 1 is a schematic diagram of an embodiment of a blood sampling device of the present invention with a plasma separation circuit attached.

FIG. 2 is a perspective view of an embodiment of the blood sampling apparatus of the present invention without a plasma separation circuit attached.

FIG. 3 is a flowchart for explaining the control contents of the degree of decompression in the blood sampling apparatus according to the embodiment of the present invention.

FIG. 4 is a flowchart for explaining the control of the degree of decompression in the blood sampling apparatus according to the embodiment of the present invention.

FIG. 5 is a time chart showing an example of controlling the degree of decompression in the blood sampling apparatus according to the embodiment of the present invention.

FIG. 6 is a flowchart for explaining the operation of the blood sampling device according to the embodiment of the present invention.

FIG. 7 is a flowchart for explaining the operation of the blood sampling apparatus according to the embodiment of the present invention.

FIG. 8 is a flowchart for explaining the operation of the blood sampling device according to the embodiment of the present invention.

FIG. 9 is a flowchart for explaining the operation of the blood sampling device according to the embodiment of the present invention.

FIG. 10 is a flowchart for explaining the operation of the blood sampling apparatus according to the embodiment of the present invention.

FIG. 11 is a flowchart for explaining the operation of the blood sampling device according to the embodiment of the present invention.

FIG. 12 is a flowchart for explaining the operation of the blood sampling apparatus according to the embodiment of the present invention.

FIG. 13 is a flowchart for explaining the operation of the blood sampling device according to the embodiment of the present invention.

FIG. 14 is a flowchart for explaining the operation of the blood sampling device according to the embodiment of the present invention.

FIG. 15 is a flowchart for explaining the operation of the blood sampling device according to the embodiment of the present invention.

FIG. 16 is a flowchart for explaining the operation of the blood sampling device according to the embodiment of the present invention.

FIG. 17 is a flowchart for explaining the operation of the blood sampling device according to the embodiment of the present invention.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Blood collection apparatus 2 1st blood supply vessel 5 Blood collection container 6 2nd blood supply blood vessel 7 Plasma separator 8 3rd blood supply blood vessel 9 Plasma transport tube 10 Plasma collection container 12 First circuit opening and closing means 13 Second circuit opening and closing means 14 Third Circuit Opening / Closing Means 41 Blood Collection Container Storage Room 42 Swinging Means 57 Blood Collection Container Weight Detector 58 Depressurization / Pressurization Means 59 Control Unit 67 Slit Detector 98 Blood Collection Container Storage 99 Plasma Weight Detector

──────────────────────────────────────────────────続 き Continuation of the front page (56) References JP-A-4-71564 (JP, A) JP-A-4-329964 (JP, A) JP-A-1-288235 (JP, A) JP-A-2- 195963 (JP, A) JP-A-2-252441 (JP, A) JP-A-48-69395 (JP, A) (58) Fields investigated (Int. Cl. ⁷ , DB name) A61M 1/02

Claims (11)

(57) [Claims] 1. A blood collection device comprising a blood collection needle, a blood collection container, and a blood supply tube communicating with the blood collection needle and the blood collection container for controlling a blood collection circuit for collecting blood from a blood collector. The blood collection device includes a blood collection container storage chamber that stores the blood collection container of the blood collection circuit, a decompression unit for reducing the pressure in the storage chamber, and an amount of blood collected in the blood collection container. a blood volume detecting means for detecting a and a said pressure reduction means and a control unit for controlling the blood volume detecting means, the control unit based on the output signal from the blood volume detecting means, constant during blood collection Blood change to calculate blood change per time
The amount calculation function is set according to the degree of pressure reduction of the pressure reducing means.
Setting change amount storage function, and the blood change amount and the setting change
And a comparison / judgment function for comparing and judging the amount of
The comparison / judgment function makes the blood change amount the set change amount.
If it is determined that the pressure is larger or almost equal,
To increase the degree of decompression, and the blood change amount is
If it is determined that it is smaller than the set change amount, the pressure reducing means
Control the decompression means during blood collection so as to reduce the degree of decompression.
Control function, and further, a pressure reducing means of the control unit.
The control function of controlling the blood change amount is the set change
If it is smaller than the amount, the pressure reduction degree of the pressure reducing means is set to the first setting.
Decrease by a fixed value, and then use the comparison /
When the blood change amount becomes larger than the set change amount,
In this case, the pressure reduction degree of the pressure reduction means is smaller than the first set value.
Control to increase by the second set value.
In addition, the control unit is configured to set a minimum pressure reduction degree to a maximum setting pressure reduction.
Within this degree, the degree of decompression of the decompression means is controlled.
A blood sampling device characterized by the following. Wherein said control unit, when the blood volume change is larger than the set amount of change, a decompression degree of the pressure reducing means to claim 1 also for a is controlled so as to increase by a predetermined set value <br / > Blood sampling device as described. 3. The control unit, when the blood change amount is larger than the set change amount, sets the degree of decompression of the decompression unit to a first degree.
When the blood change amount becomes smaller than the set change amount by increasing the decompression degree of the decompression means by the first set value, the decompression degree of the decompression means is set to the first set value. 3. The blood sampling device according to claim 1, wherein the blood sampling device is controlled to lower by a set value. 4. The control section raises the degree of decompression of the decompression means to a level higher by one when the blood change amount is larger than the set change amount, and when the blood change amount is smaller than the set change amount. Control the pressure reduction degree of said pressure reduction means to lower it by one level.
4. The blood collection device according to any one of 3 . 5. The control section, when the blood change amount is smaller than the set change amount, reduces the degree of decompression of the decompression means to a level lower by one, and determines the blood change amount by the subsequent judgment. If was greater than the variation, claims 1 and controls to raise only difference is smaller than a second set value of the vacuum degree two levels of the pressure reducing means 4
The blood collection device according to any one of the above. 6. A blood collection circuit having a blood collection container for collecting whole blood from a blood collector, an anticoagulant addition circuit for adding a blood anticoagulant to the collected whole blood, and an anticoagulant A plasma separation circuit that separates the whole blood to which the added blood component is separated into a plasma component and a blood component, and a plasma storage circuit that stores the separated plasma component,
A plasma collection device for controlling a plasma collection circuit having at least a blood cell component return circuit for returning a separated blood cell component to a blood sampler, wherein the plasma collection device is a blood collection container of the blood collection circuit. A blood collection container storage chamber for storing, a decompression / pressurization means for decompressing or pressurizing the inside of the storage chamber, and a blood amount detection means for detecting an amount of blood collected in the blood collection container,
A control unit for controlling the decompression / pressurization unit and the blood volume detection unit, wherein the control unit is configured to perform control based on an output signal from the blood volume detection unit.
Blood change amount calculation to calculate the blood change amount at certain time intervals
The function is set according to the degree of decompression of the decompression / pressurization means.
Setting change amount storage function, and the blood change amount and the setting change
A comparison / judgment function to judge by comparing with
・ By the judgment function, the blood change amount is equal to the set change amount.
If the pressure is greater than or almost equal to the
The blood change is less than the set change
In such a case, the pressure reduction degree of the pressure reduction / pressurization means is reduced.
Having a control function of controlling the pressure reducing / pressurizing means during blood collection
Control means for controlling the pressure reducing / pressurizing means of the control unit.
The control function is such that the blood change amount is smaller than the set change amount.
In this case, the degree of pressure reduction of the pressure reducing / pressurizing means is the first set value.
Down, and the subsequent comparison and
When the blood change amount is larger than the set change amount,
The pressure reduction degree of the pressure reduction / pressure application means is smaller than a first set value.
Control to increase by the second set value.
In addition, the control unit is configured to set a minimum pressure reduction degree to a maximum setting pressure reduction.
Within the degree, to control the degree of decompression of the decompression / pressurization means.
A plasma collection device, comprising: 7. The control section stores a decompression degree at which the blood change amount becomes the set change amount in a previous blood collection, and at the time of starting the next blood collection, the blood collection is performed at the depressurization degree stored by the decompression / pressurization means. The plasma collection device according to claim 6 , wherein the plasma collection device is controlled to start. 8. The control section has a decompression degree storage function for storing the decompression degree at or near the end of the previous blood sampling operation, and further, at the start of the next blood sampling, starting with the stored decompression degree, 7. The plasma collection device according to claim 6 , wherein the device controls the pressure reducing / pressurizing means. Wherein said control unit is best decompression degree, the lowest degree of vacuum, either 6 to claim stores reduced pressure of a plurality of levels that are set between the minimum vacuum level and the highest degree of vacuum 8 5. The plasma collection device according to item 1. 10. The control section, when the blood change amount is larger than the set change amount, increases the degree of decompression of the decompression / pressurization means by a predetermined set value, and sets the blood change amount to the set change amount. If the number is less than the predetermined value, control is performed such that the degree of pressure reduction of the pressure reducing / pressurizing means is reduced by a predetermined set value.
10. The plasma collection device according to any one of 6 to 9 . 11. The blood plasma collecting apparatus according to claim 1, wherein the blood collecting needle, a blood collecting container, a blood collecting circuit having the blood collecting needle and the blood collecting container, and an anticoagulant for adding a blood anticoagulant to collected whole blood. An addition circuit, a plasma separation means for separating whole blood to which an anticoagulant has been added into a plasma component and a blood cell component, a plasma collection container for collecting the separated plasma component, and returning the separated blood cell component to a blood collector And a plasma collection device for controlling a plasma separation circuit having at least a blood cell component return circuit for performing a blood cell component return circuit. After injecting a predetermined amount of an anticoagulant from the anticoagulant storage container into the blood collection container, air bleeding and an anticoagulant that flow the anticoagulant into the first blood vessel together with the air inside the blood collection container Inflow step and air bleeding After the coagulant inflow step is completed, the decompression / pressurization means is operated to make the interior of the blood collection container storage chamber into a reduced pressure state, and a predetermined amount of the anticoagulant is injected from the anticoagulant storage container into the blood collection container. After the anticoagulant injecting step and the anticoagulant injecting step are completed, the pressure reducing / pressurizing means is operated to put the inside of the blood collection container storage chamber into a reduced pressure state, and a predetermined amount of blood is supplied from the blood donor into the blood collection container. A blood collection step of collecting blood while controlling the degree of decompression as described above, and after the blood collection step is completed, the decompression / pressurization means is operated to pressurize the inside of the blood collection container storage chamber, and the inside of the blood collection container is The collected blood is allowed to flow into the plasma separator, the plasma component flowing out of the plasma outlet of the plasma separator is collected in a plasma collection container, and the blood cell component flowing out of the blood cell outlet of the plasma separator is supplied to the donor. Separation to return blood Plasma collection apparatus according to claim 6 is intended to perform a blood return step.