JPH05192395A - Blood plasma collecting device - Google Patents

Abstract

PURPOSE:To easily collect a precise quantity of blood plasma by detecting blood plasma quantity and whole blood quantity, calculating a proper blood collecting quantity in the following blood plasma collecting work on the basis of the blood plasma collecting quantity, and controlling the collection of whole blood. CONSTITUTION:A blood plasma collecting device 1 is formed of an adding circuit including an anticoagulant vessel 45 for adding an anticoagulant to the whole blood collected by a blood collecting circuit including a blood collecting needle 21, and a returning circuit including a blood plasma separator 7 for separating the whole blood into blood plasma component and blood corpuscle component and a blood sending tube 8 for returning the separated blood corpuscle component to a blood donor. A weight detecting part 99 for detecting the blood plasma quantity collected in a blood plasma collecting vessel 10 and a weight detecting part 57 for detecting the whole blood quantity collected in a blood collecting vessel 5 are also provided. A control parts 59 controls the blood plasma collecting work for collecting the blood plasma component to the blood plasma collecting vessel 10 and returning the blood corpuscle component to the blood donor so as to be repeatedly performed until the total blood plasma collecting quantity reaches a target set blood plasma collecting quantity.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a plasma collecting apparatus used for collecting plasma from blood.

[0002]

2. Description of the Related Art As a conventional plasma separation device, for example,
A two-needle plasma separator (Japanese Patent Laid-Open No. 59-209347) that alternately separates the positions of two blood collection containers and continuously separates plasma by using gravity, or, for example, one Single-needle plasma separation apparatus for performing intermittent plasma separation by using gravity to move the blood collection container up and down (JP-A-60-7852).
Issue).

However, in the two-needle plasma separation apparatus in which the above-mentioned two blood collection containers are alternately moved up and down and the plasma is continuously separated by utilizing gravity, a blood collection needle and a blood return needle are provided to the blood donor. In this device, the blood collected from the vein of the donor must be perfused by the drop between the donor and the plasma separator, and
Plasma will be collected with the container for collecting plasma and the container for storing concentrated red blood cells below the plasma separator, and the position at which the operation will be performed will be considerably low, making it difficult to perform plasma collection operation and It is difficult to secure a head with the plasma separator, and in particular, it is difficult to secure a necessary head in a narrow blood donation vehicle.

Further, in a single-needle plasma separation apparatus in which one blood collection container as described above is moved up and down to intermittently perform plasma separation operation using gravity, blood collected from a donor's vein is donated. Must be perfused due to the drop between the person and the plasma separator, and the plasma should be collected with the container for collecting plasma and the container for storing concentrated red blood cells below the plasma separator. The position where the blood flow is performed becomes considerably low, and it becomes difficult to perform plasma collection operation, and it is also difficult to secure a head between the blood donor and the plasma separator, especially in a narrow blood donation vehicle. Have a point. Further, since the respective constituent elements of the plasma separation device are located apart from each other, the operation parts are dispersed, which makes the operation difficult.

Therefore, the applicant of the present invention has solved the above-mentioned problems, has a simple circuit configuration, can downsize the entire apparatus, can be used even in a narrow blood donation vehicle, and can further perfuse blood into the plasma separator. For collecting plasma using a single-needle plasma separation device and a single-needle plasma separation circuit, which allows the operation site to be concentrated without the need to secure a head A plasma collection device is provided (Japanese Patent Laid-Open No. 2-98365).

[0006]

Although the above-mentioned device has a sufficient effect, it is not possible to accurately control the amount of collected plasma because the amount of collected plasma is controlled by the amount of collected blood. That is,
Since the amount of plasma that can be collected from a single blood collection varies from person to person, the amount of plasma collected also varies from person to person, and there is a problem that an accurate and target amount of plasma cannot be collected. Therefore, an object of the present invention is to solve the above problems,
An object of the present invention is to provide a plasma collection device capable of collecting an accurate amount of plasma and easily collecting plasma.

[0007]

[Means for Solving the Problems] What achieves the above-mentioned object is to collect a whole blood from a blood sampler, and to add an anticoagulant for adding a blood anticoagulant to the collected whole blood. Circuit, plasma separating means for separating whole blood added with anticoagulant into plasma component and blood cell component, plasma collection container for collecting the separated plasma component, and returning the separated blood cell component to a blood sampler A plasma collection device for controlling a plasma separation circuit that has at least a blood cell component return circuit, wherein the plasma collection device detects a plasma amount collected in the plasma collection container. And a second detecting a total blood amount collected in a blood collecting container provided in the blood collecting circuit
Whole blood is collected by the weight detection unit and the blood collection circuit, the collected whole blood is separated into a plasma component and a blood cell component, the plasma component is collected in the plasma collection container, and the blood cell component is returned to the blood sampler. And a control unit that controls the plasma collection operation to be repeated until the total plasma collection amount reaches the target plasma collection amount, and the control unit is weighed by the first weight detection unit. Based on the amount of plasma collected according to (1)-
Formula (5) Plasma collection efficiency (η) = Current plasma collection amount / Set blood collection amount ... (1) Remaining plasma collection amount = Set plasma collection amount-Plasma collection integrated value ... ( 2) Next expected plasma collection volume = set blood collection volume x η ... (3) Remaining plasma collection volume ≥ next expected plasma collection volume Next blood collection volume = set blood collection volume ... (4 ) Remaining plasma collection volume <next expected plasma collection volume Next blood collection volume = set blood collection volume / η + α ··· (5) (where α is the hematocrit value of the blood sampler and the performance of the plasma separation means) In consideration of the decrease in plasma collection efficiency due to the decrease, it is a set amount, usually a value of about 10 to 30 g.), An appropriate blood collection amount for the next plasma collection work is calculated, and the calculated value is calculated. Plasma having a blood collection volume control mechanism for controlling collection of whole blood based on A winding device.

Further, it is preferable that the plasma collecting apparatus has a pressure detecting section for detecting the pressure of the blood container housing section. Further, it is preferable that the plasma collecting apparatus has a swinging unit for shaking the blood collecting container. Furthermore, it is preferable that the plasma collection apparatus has a cuff pressurizing means that is attached to the blood donor. Furthermore, it is preferable that the plasma collection device has a cuff pressure detection unit.

Therefore, the plasma collection apparatus of the present invention will be described with reference to the embodiments shown in the drawings. A schematic diagram of the basic configuration of the plasma collection apparatus 1 of this example is shown in FIG. In addition, in FIG.
Plasma collection device 1 with single-needle plasma separation circuit attached
Is shown.

The plasma collection apparatus 1 includes a blood collection circuit for collecting whole blood from a blood sampler, an anticoagulant addition circuit for adding a blood anticoagulant to the collected whole blood, and an anticoagulant addition. A plasma separating means for separating the separated whole blood into a plasma component and a blood cell component, and a plasma collection container for collecting the separated plasma component,
It is a plasma collection device for controlling a plasma separation circuit which has at least a blood cell component return circuit for returning the separated blood cell components to a blood sampler. And the plasma collection device 1
Is a first weight detection unit 99 that detects the amount of plasma collected in the plasma collection container 10, and a second weight detection unit 57 that detects the amount of whole blood collected in the blood collection container 5 provided in the blood collection circuit.
And collecting whole blood by a blood collection circuit, separating the collected whole blood into a plasma component and a blood cell component, and collecting the plasma component from the plasma collection container 10
And a control unit 59 for controlling the plasma collection work of collecting blood cells and returning the blood cell components to the blood collector so as to be repeatedly performed until the total plasma collection amount reaches the target set plasma collection amount. ..

As shown in FIGS. 1 and 3, the blood collecting circuit includes a blood collecting needle 21, a blood collecting container 5, and a blood collecting needle 21.
And a sixth blood supply vessel 6 that connects the blood collection container 5 and the blood inlet of the plasma separator 7 to each other. The anticoagulant addition circuit is shown in Fig. 1.
As shown in FIG. 3 and FIG. 3, it is composed of an anticoagulant container 45 and an anticoagulant transport pipe 48 that connects the anticoagulant container 45 and the blood collecting container 5 to each other. As shown in FIGS. 1 and 3, the plasma separating means is composed of a plasma separator 7 and a plasma transport pipe 9 connected to the plasma outlet of the plasma separator 7. Further, a plasma collection container 10 is attached to the plasma transportation tube 9. The blood cell component return circuit is composed of the third blood supply vessel 8 that connects the blood outlet (blood cell component outlet) of the plasma separator 7 and the first blood supply vessel 2.

Specifically, the plasma collection device 1 includes a blood collection needle 2
1, a blood collection container 5, a first blood supply tube 2 that connects the blood collection needle 21 and the blood collection container 5, a plasma separator 7, a blood collection container 5 and a blood inlet of the plasma separator 7 A second blood supply vessel 6, a third blood supply vessel 8 that connects the blood outlet of the plasma separator 7 with the first blood supply vessel 2, a plasma collection container 10, a plasma outlet of the plasma separator 7, and plasma. A plasma collection apparatus equipped with a plasma separation circuit having at least a plasma transport tube 9 communicating with a collection container 10. This plasma collection apparatus 1
Is a blood collection container storage section 41 and a decompression / pressurization means 58 for pressurizing and depressurizing the inside of the blood collection container storage section 41.
, A plasma separator attachment portion to which the plasma separator 7 is detachably attached, a first circuit opening / closing means 12 for opening and closing the first blood supply vessel 2 of the plasma separation circuit, and the second blood supply vessel 6 or the third blood supply vessel 6. Second circuit opening / closing means 13 for opening / closing the blood vessel 8 and third circuit opening / closing means 14 for opening / closing the plasma transport tube 9.
And a first weight detection unit 99 for detecting the weight of the plasma collection container 10.

Further, the plasma collection apparatus 1 detects the pressure inside the blood collection container storage section 41 and the swinging means 42 for shaking the blood collection container 5 stored inside the blood collection container storage section 41. To detect the weight of the blood collection container 5 stored in the blood collection container storage unit 41, and the cuff 49 attached to the arm of the blood collector. Pressurizing means 44 for pressurizing and this cuff 4
It has a pressure detection unit 56 for detecting the pressure of 9.

The single-needle plasma separation circuit shown here has an anticoagulant container 45 and an anticoagulant container 4
5 has an anticoagulant transport tube 48 communicating with the blood collection container 5, and the plasma collection apparatus 1 further has a fourth circuit opening / closing means 46 for opening / closing the anticoagulant transport tube 48. is doing. In the single-needle plasma separation circuit, as shown in FIG. 1, the first blood supply vessel 2, the second blood supply vessel 6, and the anticoagulant transport tube 48 are connected to the blood collection container 5 through a tube 93 and a branch. It communicates with the blood collection container 5 via the tube 95. Further, as shown in FIG. 1, the first blood supply tube 2, the second blood supply tube 6, and the anticoagulant transport tube 48 may be directly connected to the blood collection container 5.

More specifically, the pressure reducing / pressurizing means 58
Is a supply / exhaust circuit 53 and pressurization / decompression switching valves 51, 5
2, a vacuum pump 43, and a leak valve 50. The swinging means 42 is composed of a swinging crank and a swinging motor for swinging the blood sampling container storage base 98 provided in the blood sampling container storage portion 41. Further, the depressurizing / pressurizing means 58, the swinging means 42, the pressure detecting section 55, the second weight detecting section 57 of the blood collecting container, the first weight detecting section 99 of the blood plasma collecting container 10, and the pressurization of the cuff 49. The means 44, the pressure detector 56 of the cuff 49, the leak valve 54, and the circuit opening / closing means 12, 13, 14, 46 are all electrically connected to the controller 59. This control unit 59
Controls each component as shown in the flowcharts of FIGS. 4 to 13 described later. FIG. 2 shows an example in which the plasma collection device having such a configuration is specifically created. FIG. 3 is a diagram showing an embodiment of a plasma collection circuit used in the plasma collection device.

Therefore, the plasma collecting apparatus 1 of the present invention is shown in FIG.
A more specific description will be made with reference to FIGS. As shown in FIG. 2, the blood plasma collecting apparatus 1 has a lid 83 that is obliquely provided on the upper surface, and the lid 83 is further provided with a lid open / close detection unit. This lid opening / closing detection unit is configured to detect the opening / closing using a magnet and a Hall IC (not shown) installed on the lid 83, for example. Inside the lid 83, a blood collection container storage portion 41 is formed which is a closed space when the lid 83 is closed. Inside the blood collection container storage portion 41, a blood collection container storage base 98 is inclined. Is provided.

The blood collection container 5 is installed in the storage base 98 so that the tube side is low (front side). Further, the blood collection container storage base 98 is provided with a swinging means 42 which is rotatably supported on the tube side and is constituted by a swinging crank and a swinging motor for vertically driving the swinging crank. Has been. The inclination angle of the blood sampling container storage base 98 is set to + 20 ° with respect to the initial state and the horizontal position, and the swinging means 42 is
The storage base 98 is configured to swing with an amplitude of ± 20 ° with respect to the horizontal state. Further, a depressurizing / pressurizing means 58 is connected to the blood collection container storage portion 41,
The inside of the storage unit 41 can be pressurized and depressurized. As shown in FIG. 1, the pressure reducing / pressurizing means 58 is composed of an air supply / exhaust circuit 53, a vacuum pump 43, and two three-port valves 51, 52. The depressurizing / pressurizing means 58 operates in a depressurized state of -100 to -200 mmHg.
Can be set for each 10 mmHg, and as a pressurization state, +50 to +200 mmHg can be set for each 10 mmHg. This set pressure is
Input is possible from the front panel 80 shown in FIG. The reduced pressure and the increased pressure are controlled by the vacuum pump 43.
The ON / OFF state is used to maintain a substantially constant pressure, and the 3-port valves 51 and 52 are switched to switch between the depressurized and pressurized states. Therefore, the operation of the pressure reducing / pressurizing means 58 will be described by using the operating states of the three-port valves 51 and 52. The three-port valves 51 and 52 are in a ventilation state when they are in an on state, and are open to the atmosphere when they are in an off state. Therefore, if only the 3 port valve 51 is turned on (the 3 port valve 52 is turned off), the vacuum pump 43 is operated to evacuate and the inside of the blood collection container storage portion 41 shown in FIG. Conversely, 3 port valve 52
If only one of them is turned on (the three-port valve 51 is turned off), the vacuum pump 43 is actuated to inhale air, and the inside of the blood collection container storage portion 41 is put into a pressurized state.

Further, as shown in FIG. 1, a pressure detecting means 55 for detecting the internal pressure, such as a pressure sensor, is attached to the blood collection container storage portion 41. Specifically, the pressure detection means 55 is attached so as to communicate with the blood collection container storage portion 41 via a tube. A diffusion type semiconductor pressure detecting means is preferably used as the pressure detecting means 55. Further, in the blood collection container storage portion 41, as shown in FIG.
, The second weight detection unit 57 of the blood collection container 5,
For example, a weight sensor is provided. Specifically, the second weight detection unit 57 of the blood collection container 5 is attached to the blood collection container storage base 98. The second weight detection unit 57 is
A load cell is preferably used as the second weight detection unit 57 for detecting the weight of blood in the blood collection container 5. Further, a blood leak sensor (not shown) is attached to the blood collection container storage portion 41. This blood leak sensor is also attached to the storage base 98 so that the sensor portion is exposed on the upper surface of the blood collection container storage base 98. The blood leak sensor is configured, for example, by fixing a spacer on a load cell forming a weight sensor and fixing a printed circuit board forming the blood leak sensor thereon.

The circuit opening / closing means 12, 13, 14,
46 is preferably a solenoid pinch valve which is closed in a normal state. Furthermore, as shown in FIG. 2, an ACD bag hanger 85 is provided on the left side surface of the plasma collection apparatus 1. In addition, the plasma 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 surface of approximately 2 mm with a fulcrum approximately 30 mm below the center.
The plasma separator can be attached at an angle of 0 °, and the attached state can be held and released by a latch type magnetic catch. Further, a cuff pressurizing port 93 is provided on the entire surface of the plasma collection apparatus 1, and as shown in FIG. 1, a tube connected to the cuff 49 can be attached. The cuff pressurizing port 93 is connected to the cuff pressure pump 44 provided in the plasma collection apparatus 1, and a pressure sensor 56 for detecting the pressure inside the port 93 and a leak valve 54 are attached. .. Cuff pressurizing pump 4
A small pump for a blood pressure monitor can be preferably used as 4, and a diffusion type semiconductor pressure sensor can be suitably used as the pressure sensor 56. The pressure applied to the cuff 49 from the cuff pressurizing port 93 is configured so that +10 to +100 mmHg can be set for each 10 mmHg.
This set pressure can be input from the front panel 80 shown in FIG. Furthermore, the plasma collection device 1
Includes bubble detection means 97 for detecting bubbles in the third blood supply vessel as shown in FIG. An ultrasonic bubble sensor can be preferably used as the bubble detecting means.

As shown in FIG. 2, the plasma collection apparatus 1 is provided with a first weight detection unit 99 for detecting the weight of the plasma collection container 10, and the first weight detection unit 99 is provided. An electronic balance with an external output is preferably used as the unit 99, the weight of the plasma collection container 10 is measured by the first weight detection unit 99 at a constant cycle, and the measurement data is stored in the control unit 59. Is entered. In addition, as shown in FIG. 3, the plasma collection device 1 includes a plurality of plasma collection containers 10.
a, 10b, and 10c have a plurality of weight detection units 99a, 99b, 99c for measuring the respective weights,
The total amount of plasma weight detected by the three weight detection units may be detected.

Next, the operation of the plasma collection apparatus 1 of the present invention will be described.
This will be described with reference to FIGS. 1 and 4 to 13. In particular, as the plasma collection device 1, a blood collection needle 21, a blood collection container 5,
First blood supply tube 2 that connects the blood collection needle 21 and the blood collection container 5
And a plasma separator 7, a second blood supply vessel 6 that connects the blood collection container 5 and the blood inlet of the plasma separator 7, and a blood outlet of the plasma separator 7 and the first blood supply vessel 2. Third blood vessel 8
And a plasma collection container 10, a plasma transport pipe 9 that connects the plasma outlet of the plasma separator 7 and the plasma collection container 10, an anticoagulant storage container 45, an anticoagulant storage container 45, and blood collection Using the single-needle plasma separation circuit having the anticoagulant transport tube 48 that communicates with the container 5, the plasma collection device 1 pressurizes and depressurizes the blood sampling container storage part 41 and the inside of the blood sampling container storage part 41. Depressurizing / pressurizing means 58, a plasma separator attaching portion to which the plasma separator 7 is detachably attached, and a first circuit opening / closing means for opening / closing the first blood supply vessel 2 of the single-needle plasma separation circuit. 12, a second circuit opening / closing means 13 for opening / closing the second blood sending vessel 6 or the third blood sending vessel 8, a third circuit opening / closing means 14 for opening / closing the plasma transportation tube 9, and an anticoagulant transportation A fourth circuit opening / closing means 46 for opening / closing the tube 48;
First weight detection unit 9 for detecting the weight of the plasma collection container 10
9 and, further, the plasma collection apparatus 1 has a reduced pressure /
An anticoagulant injecting step of injecting a predetermined amount of the anticoagulant from the anticoagulant storage container 45 into the blood collection container 5 by depressurizing the blood collection container storage part 41 by operating the pressurizing means 58. After the anticoagulant injection step is completed, depressurize /
The pressurizing means 58 is operated to bring the inside of the blood collection container storage portion 41 into a decompressed state, and a blood collecting step of collecting a predetermined amount of blood from the donor in the blood collecting container 5 and decompression / reduction after the blood collecting step is completed. The pressurizing means 58 is activated to bring the inside of the blood collection container storage portion 41 into a pressurized state to return the blood in the first blood supply vessel 2 to the donor and the blood collection container 5 in the first blood supply vessel 2. After the small amount blood returning step for flowing the collected blood into the inside and the small amount blood returning step are completed, the depressurizing / pressurizing means 58 is operated to bring the inside of the blood collecting container storage portion 41 into a pressurized state, and the blood collecting container The blood collected inside 5 is made to flow 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,
The blood cell component flowing out from the blood cell outlet of the plasma separator 7 is subjected to a separation / return step of returning blood to the donor, and this separation / return step is performed by the first weight of the plasma collection container 10. The detection unit 99 ends when the weight of the set value is detected.

The blood plasma collecting apparatus 1 repeats the anticoagulant injecting step, the blood collecting step, the small amount blood returning step, and the separating / blood returning step in this order, and repeats the set number of times. The steps and the progression of steps are largely automated.

In particular, with reference to FIGS. 4 to 13, a case will be described as an example where the blood collection container 5 for 200 ml is used to perform plasma collection five times. First, as shown in FIG. 4, when the power switch of the plasma collection apparatus 1 is turned on, after initializing the CPU as initialization, the electrical abnormality of each part is automatically checked. Next, the blood collection amount (200 ml or 400 ml, 200 ml in this description) is set, the processing mode [only blood collection or apheresis (plasma collection), apheresis in this description] is set, and the number of blood collections (5 in this description). Times)
Setting and default data of each setting parameter is R
Transferred to AM. 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 plasma collection apparatus 1. When the lid 83 is opened, the circuit opening / closing means 12
(CL12), 13 (CL13), 14 (CL14),
46 (CL46) is in an open state. Further, the leak valve 50 (LV50) of the pressure reducing / pressurizing means 58 is in an open state, and the pressure reducing / pressurizing switching valve 51 of the pressure reducing / pressurizing means 58.
Both (V51) and 52 (V52) are open to the atmosphere. Then, the weight of the blood collection container storage base 98 is detected and stored as TWO. Then, if there is no error in the setting of the blood collection container 5, as the default data set, the blood collection weight is 200 ml and the number of blood collections (Ns) =
5. The processing mode (apheresis) is input. Then, the tube connected to the cuff 49 is attached to the cuff pressurizing port 93, and the cuff 49 is attached to the blood donor. After the above setting is completed, turn on the start switch on the front panel.
Move to. Then, the weight of the blood collection container 5 is detected (TW
5) Then, the weight of the blood collection container 5 is abnormal (TWO ≧ TW5)
Then, it is detected that the blood sampling container 5 is not stored in the blood sampling container storage portion 41, an alarm is activated, and the process proceeds to the mounting processing routine. Also, if blood leaks or the lid is open, an alarm will be activated. When the above alarm is not activated, the start lamp is turned on, the mode shifts to the anticoagulant injection mode, N = Ns (N = 5 in this case) is input, and the pressure of the blood collection container storage section 41 is input. Detection of (BP) is started.

Subsequently, the processing mode, in this case, apheresis is determined, the process proceeds to [6] in the flowchart shown in FIG. 6, and the anticoagulant lamp (ACD lamp) provided on the front panel is turned on. , Leak valve 5
0 is closed, the pressure reducing / pressurizing switching valve 51 is ventilated, the circuit opening / closing means 46 is opened, the vacuum pump 43 is activated, and the inside of the blood collection container housing 41 is depressurized. An anticoagulant (for example, ACD solution) is injected into the blood collection container 5 from the storage container 45.
In the case of blood collection only, the process proceeds to [5] in the flowchart shown in FIG. In the injection of the anticoagulant, the first weight detection unit 57 subtracts the weight (NWo) before filling the anticoagulant from the weight (NWn) of the blood collection container 5 as follows:
This is performed until it is detected that the anticoagulant set weight (Wo) or more (NWn-NWo≥Wo) is reached, and when the above-mentioned state is reached, the operation of the vacuum pump 43 (VP43) is stopped and the circuit opening / closing means. 46 is closed, the leak valve 50 is opened, and the work of injecting the anticoagulant is completed. Further, before NWn−NWo ≧ Wo is reached within a predetermined time, it is always judged whether or not an abnormality has occurred, and 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 (CP44) is operated. When the cuff pressure becomes higher than the set value (P2) (CPR ≧ P
2) The standby alarm is activated, the ACD lamp goes off, and the start lamp blinks. Also, within a predetermined time, C
While PR ≧ P2 is not reached, it is always judged whether or not the cuff pressure is abnormal, and when the abnormality occurs, the abnormality processing is performed and the process proceeds to [7] of the flowchart.

Then, the puncture needle 21 is punctured into the vein of the blood donor, and after confirming that the blood has flowed into the blood supply vessel from the puncture 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 proceeds to the flowchart [8] shown in FIG. 7, the cuff pressurizing pump 44 maintains the operating state, and as described later, the pressure is kept at a predetermined level by the ON / OFF operation of the pump as in the vacuum pump 43. Maintained within pressure range. Blood flows into the blood collection container 5 by the operation of the vacuum pump 43. The weight of the blood sampling container 5 is sequentially detected by the first weight detection unit 57, and the weight (NWn) of the blood sampling container 5 is the set weight [W1 = the set blood sampling weight + the anticoagulant weight ( Wo)] or more (NWn ≧ W1) is reached, the circuit opening / closing means 12 is closed, the leak valve 50 is opened, and the operation of the vacuum pump 43, the swing motor 42, and the cuff pressurizing pump 44 is stopped. 51 is also open to the atmosphere, and the blood collection work is completed. Then, the separation / return blood lamp is turned on, and the mode returns to the small blood return mode. Further, before NWn ≧ W1 is reached within a predetermined time, it is always judged whether an abnormality has occurred, and if an abnormality has occurred, abnormality processing is performed. When the additional rocking data is set, further rocking is performed and the blood sampling lamp is turned off. And the processing mode (only blood sampling or apheresis, in this case,
Apheresis), and the process proceeds to [9] in the flowchart shown in FIG.

From here, the mode returns to the small blood return mode, and the separated blood return lamp is turned on. In this small-volume blood-return mode, the blood in the first blood supply tube 2 is in a state where no anticoagulant is added after blood collection is completed, and if left as it is, the blood in the first blood supply tube 2 will coagulate. By returning a small amount of blood, the blood in the first blood supply vessel 2 is returned to the donor, and the first
This is performed in order to prevent the blood coagulation in the blood supply vessel 2 by allowing the blood containing the anticoagulant in the blood collection container 5 to flow into the blood supply vessel 2. In the small amount blood return mode, the leak valve 50 is closed, the valve 51 is open to the atmosphere, the valve 52 is vented, and the vacuum pump 43 is activated.
The inside of the blood collection container storage portion 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 opened. In this small amount of blood return, the weight obtained by subtracting the weight (TWn) of the blood collection container 5 from the weight of the blood collection container 5 (TW3) before the blood return is [the set blood return weight of anticoagulant-added blood (W2)]. The process is repeated until (TW3−TWn ≧ W2) is reached, and when the set weight is reached, the small amount blood returning operation is completed, the mode is changed to the separation / blood returning mode, and the circuit opening / closing means 12
Is closed and the circuit opening / closing means 13 is opened. Further, before TW3−TWn ≧ W2 is reached within a predetermined time, it is always judged whether or not an abnormality has occurred, and if an abnormality has occurred, abnormality processing is performed. Then, the remaining number of blood samplings (N = Ns) is determined, and N = Ns (in this case, N = Ns).
5) That is, when it is determined that it is the first time, the circuit opening / closing means 14 is slightly delayed to be in the open state. this is,
The opening timing of the circuit opening / closing means 14 is set to 10 to prevent the plasma from being diluted by the priming liquid (physiological saline) filled in the plasma separator 7 only for the first time.
This is because the priming solution (physiological saline) is allowed to flow out after a delay of 20 seconds. In the separation / return blood mode, the circuit opening / closing means 13 and 14 are in the open state, 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
Flow into. Further, the blood cell component flowing out from the plasma separator 7 is returned to the donor through the third blood vessel 8 and the first blood vessel 2.

The weight of the plasma collection container 10 is measured by the first weight detection unit 99 in a constant cycle. Then, this work is performed with the blood collecting container 5 in a state where the weight of the plasma collecting container 10 does not reach the set plasma collecting amount.
Is a set threshold value, in other words, the weight (TWn) of the blood collection container 5 is greater than the weight (TWn) of the blood collection container 5 before the blood collection.
5) is less than the set weight (Wth) (TWn-T
W5 ≦ Wth), and 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 volume / Set blood collection volume (1) Remaining plasma collection volume = Set plasma collection volume-Plasma collection volume integrated value (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 <For next expected plasma collection volume Next blood collection volume = remaining plasma collection volume / η + α (5) (where α is due to increase in blood hematocrit value of donor and decrease in performance of plasma separator 7) The amount is set in anticipation of a decrease in plasma collection efficiency, usually 10 to 30.
It is a value of 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 opened, the valves 51 and 52 are also opened to the atmosphere, and the operation of the vacuum pump 43 is stopped. , The separation and blood return work is completed,
The process moves to the flowchart [11] of FIG. If the weight of the plasma collection container 10 does not reach the set plasma collection amount within a predetermined time, it is determined whether an abnormality has occurred, and if the abnormality has occurred, the abnormality processing is performed. Then, it is judged whether or not the remaining number of times of blood sampling is one (N: 1). If it is not one, the process proceeds to [12] of the flowchart shown in FIG.
= N-1 is input, the number of times is counted down, and the weight of the blood collection container 5 is stored as TW1. Further, in this description, the embodiment in which the number of times is input is used, but the number of times may not be input in consideration of the above-mentioned plasma collection amount. The ACD lamp is turned on again, the leak valve 50 is closed, the valve 51 is vented, and the valve 5 is closed.
2 is open to the atmosphere, the vacuum pump 43 is operated, the circuit opening / closing means 46 is open, the leak valve 54 is closed, the cuff pressurizing pump 44 is operated, and blood is collected from the anticoagulant container 45. The weight of the anticoagulant (for example, ACD solution) in the container 5 minus TW1 from the weight (NWn) of the blood collection container 5 becomes the anticoagulant set weight (Wo) or more (NWn-TW1 ≧ Wo). When it reaches the set weight, the circuit opening / closing means 46 is closed, the operation of the vacuum pump 43 is stopped, and the ACD lamp is turned off. Further, before NWn-TW1 ≧ Wo is reached within a predetermined time, it is always judged whether or not an abnormality has occurred, and if an abnormality has occurred, abnormality processing is performed. Then, when the cuff pressure becomes higher than the set value (CPRn ≧ P2), FIG.
The process proceeds to [13] in the flowchart shown in, and blood collection is started again. Further, before CPRn ≧ P2 is reached within a predetermined time, it is constantly judged whether or not an abnormality has occurred, and if an abnormality has occurred, abnormality processing is performed.

When it is judged that the remaining number of times of blood sampling is one (N = 1), the end alarm sounds, the start lamp and the separated blood return lamp are extinguished, and then the end lamp is lit, and the blood donation is performed. The puncture needle 21 from the operator. And
By opening the lid of the plasma collection device 1, all of the circuit opening / closing means 12, 13, 14, 46 are opened, the end lamps are turned off, the blood collection container 5 is taken out from the blood collection container storage portion 41, and the plasma is collected. The plasma separator 7 is removed from the separator mounting portion to complete the plasma collection work. If necessary, without opening the lid, enter the number of times (N) from the number of times key and press the start key again to move to [14] in the flowchart of FIG. 5 and switch to the ACD injection mode again. Transition.

Further, in this flow chart, if an abnormality occurs in the detection of the weight and cuff pressure of the blood collecting container 5, the abnormality is detected and the abnormality processing is performed. Next, a warning flow of the plasma collection device 1 of the present invention will be described with reference to FIGS. 11, 12, and 13.
In this warning flow, as shown in the route on the left side of FIG. 11, during operation of the plasma collection apparatus 1, whether or not the stop switch is pressed, whether or not the blood collection amount is decreased, and whether or not the lid is opened. It is configured to sequentially determine whether or not there is blood leakage, whether or not bubbles are detected during the plasma separation and blood return modes, and when YES is determined for each, a warning flow is entered. There is. First, if a decrease in blood collection volume is detected, it is determined whether or not it is during blood collection, and if so, whether A = 1 (A = 1 means again decrease in blood collection volume). If it is judged that A = 1 is not satisfied, then FIG.
The process moves to the subroutine A shown in. In the plasma collection apparatus 1, the ON / OFF of the vacuum pump is repeated so that the pressure inside the blood collection container housing 41 has the set pressure as the upper limit and the set pressure of 0.8 to 0.9 as the lower limit. Due to
The pressure is controlled to be maintained within the above range.

The weight is detected by the weight detection unit provided in the blood collection container storage unit 41 at each swing cycle of the swinging means 42 of the blood collection container storage unit 41.
It is configured to detect a decrease in blood collection volume by comparing with the previously detected weight. Then, when this decrease in blood collection amount is detected, the process proceeds to the subroutine A shown in FIG. 13 as described above. Then, the vacuum pump 43 and the swinging means 42 are stopped, the leak valve 50 is opened, and this state is maintained for 1 second (T4). And the blood sampling pressure is 1/2 of the set pressure (P1), that is, P1
/ 2 is automatically set, and the vacuum pump 43 and the swing pump 4 are set.
2 is operated to close the leak valve 50, and A =
Automatically input 1 and start blood collection again. Then, when the blood collection amount decreases again, as shown in the flowchart of FIG. 11, it is determined that A = 1, and a value (W5) obtained by subtracting a predetermined weight (TW5) from the weight (NWn) of the blood collection container 5 is determined. )
Is greater than the set weight (Wth) (NWn-TW5
If (W)> Wth) is determined and if YES (if NO, the condition of FIG. 8 is satisfied), the low flow rate alarm lamp blinks, A = 0 is automatically input, and the alarm 82 is activated. 12, shift to [20] in the flowchart of FIG. 12, and FIG.
, The vacuum pump 43 and the swinging means 42 are stopped, the leak valve 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. Flashes.

Subsequently, it is determined whether the start switch is ON / OFF and the interruption switch is ON / OFF. Then, when it is detected that the start switch is ON and the lid 83 is closed, the interruption lamp is turned off, the start lamp is turned on, the alarm lamp is turned off, and the process proceeds to the flowchart [21] of FIG. Also, by confirming that the interruption switch is ON, an alarm lamp,
The start switch and the interruption switch are turned off, the process proceeds to [2] in the flowchart of FIG. 4, and the plasma collection work is stopped.

[0033]

The plasma collection apparatus of the present invention comprises a blood collection circuit for collecting whole blood from a blood sampler, an anticoagulant addition circuit for adding a blood anticoagulant to the collected whole blood, and an anticoagulant addition circuit. Plasma separating means for separating whole blood to which a coagulant has been added into plasma components and blood cell components, a plasma collection container for collecting the separated plasma components, and blood cell components for returning the separated blood cell components to a blood sampler A plasma collection apparatus for controlling a plasma separation circuit having at least a return circuit, the plasma collection apparatus including a first weight detection unit for detecting an amount of plasma collected in the plasma collection container, and the blood collection apparatus. A second weight detection unit that detects the amount of whole blood collected in a blood collection container provided in the circuit, and whole blood is collected by the blood collection circuit, and the collected whole blood is separated into plasma component and blood cell component, and plasma The components are collected in the plasma collection container and blood cells are collected. And a control unit that controls the plasma collection work for returning the amount to the blood sampler to be repeatedly performed until the total plasma collection amount reaches the target set plasma collection amount. Based on the amount of plasma collected by the weight detection unit, the following formulas (1) to (5) Plasma collection efficiency (η) = Current plasma collection amount / Set blood collection amount ... (1) Remaining Plasma collection amount = Set plasma collection amount-Plasma collection integrated value (2) Next expected plasma collection amount = Set blood collection x η (3) Remaining plasma collection amount ≥ Next prediction Plasma collection volume Next blood collection volume = Set blood collection volume (4) Remaining plasma collection volume <Next expected plasma collection volume Next blood collection volume = Set blood collection volume / η + α ... (5) ) (However, α is the plasma collection efficiency due to an increase in the hematocrit value of the blood sampler and a decline in the performance of the plasma separation means. The amount is set in anticipation of the lower side, and is usually a value of about 10 to 30 g.), The appropriate blood collection amount for the next plasma collection work is calculated, and the collection of whole blood is controlled based on the calculated value. Since it has a blood collection amount control mechanism, it is possible to collect an accurate amount of plasma and easily collect plasma. Further, the plasma collection device uses the output of the first weight detection unit of the plasma collection container to perform the decompression / pressurization means, the first circuit opening / closing means,
If the device has a control unit for controlling the second circuit opening / closing means and the third circuit opening / closing means, the blood plasma collection work can be automated, and therefore plasma can be collected very easily.

[Brief description of drawings]

FIG. 1 is a schematic view of an embodiment of a plasma collection apparatus of the present invention with a plasma separation circuit attached.

FIG. 2 is a perspective view of an embodiment of the plasma collection apparatus of the present invention in which the plasma separation circuit is not attached.

FIG. 3 is a diagram showing an example of a plasma collection circuit used in a plasma collection apparatus.

FIG. 4 is a flow chart for explaining the operation of the plasma collection device according to the embodiment of the present invention.

FIG. 5 is a flow chart for explaining the operation of the plasma collection device according to the embodiment of the present invention.

FIG. 6 is a flow chart for explaining the operation of the plasma collection device according to the embodiment of the present invention.

FIG. 7 is a flow chart for explaining the operation of the plasma collection device according to the embodiment of the present invention.

FIG. 8 is a flow chart for explaining the operation of the plasma collection device according to the embodiment of the present invention.

FIG. 9 is a flow chart for explaining the operation of the plasma collection device according to the embodiment of the present invention.

FIG. 10 is a flow chart for explaining the operation of the plasma collection device according to the embodiment of the present invention.

FIG. 11 is a flow chart for explaining the operation of the plasma collection device according to the embodiment of the present invention.

FIG. 12 is a flow chart for explaining the operation of the plasma collection device according to the embodiment of the present invention.

FIG. 13 is a flow chart for explaining the operation of the plasma collection device according to the embodiment of the present invention.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Plasma collection device 2 1st blood supply vessel 5 Blood collection container 6 2nd blood supply vessel 7 Plasma separator 8 3rd blood supply vessel 9 Plasma transport tube 10 Plasma collection container 12 1st circuit opening / closing means 13 2nd circuit opening / closing means 14 Third Circuit Opening / Closing Means 41 Blood Collection Container Storage 57 57 Second Weight Detector 58 Decompression / Pressure Means 59 Controller 99 First Weight Detector

Continued Front Page (72) Inventor Hiroshi Shimane 1500 Inoguchi, Nakai-cho, Ashigarakami-gun, Kanagawa Terumo Corporation

Claims (1)

[Claims] 1. A blood sampling circuit for collecting whole blood from a blood sampler, an anticoagulant addition circuit for adding a blood anticoagulant to the collected whole blood, and a whole blood to which an anticoagulant is added. Plasma separation means for separating at least a plasma component and a blood cell component, a plasma collection container for collecting the separated plasma component, and a blood cell component return circuit for returning the separated blood cell component to a blood sampler A plasma collection apparatus for controlling a circuit, wherein the plasma collection apparatus includes a first weight detection unit for detecting an amount of plasma collected in the plasma collection container, and a blood collection container provided in the blood collection circuit. A second weight detection unit that detects the amount of collected whole blood, and whole blood is collected by the blood collection circuit, the collected whole blood is separated into a plasma component and a blood cell component, and the plasma component is collected in the plasma collection container. And returns blood cell components to the blood sampler And a control unit for controlling the collection operation to be repeated until the total plasma collection amount reaches the target set plasma collection amount, and the control unit is weighed by the first weight detection unit. Based on the amount of collected plasma, the following equations (1) to (5) 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 volume (2) Next expected plasma collection volume = set blood collection volume x η (3) Remaining plasma collection volume ≥ next expected plasma collection volume Next blood collection volume = set Blood collection volume (4) Remaining plasma collection volume <Next expected plasma collection volume Next blood collection volume = Set blood collection volume / η + α (5) (where α is blood collection volume) Is set by anticipating a decrease in plasma collection efficiency due to an increase in the hematocrit value of the elderly and a decrease in the performance of the plasma separation means. The value is usually about 10 to 30 g.), And an appropriate blood collection amount for the next plasma collection operation is calculated, and a blood collection amount control mechanism for controlling collection of whole blood based on the calculated value is provided. A plasma collection device characterized in that