JP3349522B2 - Plasma separation 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 plasma separation apparatus, and more particularly, forcibly sends blood by applying pressure or the like to a blood collection bag or the like, and reduces the amount of blood sent when separating or returning blood plasma. It is about what you control.

[0002]

2. Description of the Related Art Conventionally, there has been proposed a plasma separation apparatus capable of performing a blood collection, a plasma collection, a blood return and the like by accommodating a plasma separation circuit in a compact manner in order to increase the installation space efficiency. In this device, the blood sent to the blood collection bag is operated by air pressure applied from outside the blood collection bag, regardless of the head. The blood from which the plasma has been separated by the plasma separator is also returned to the donor by the action of the pressure applied to the blood collection bag.

[0003] In such a configuration, the flow rate of blood sent out from the blood collection bag is adjusted according to the type and separation ability of the plasma separator, and the age, sex, and health condition of the donor to whom blood is returned. It is adjusted each time the separation work is performed. The adjustment of the blood supply flow rate is performed by adjusting the air pressure applied to the blood collection bag.

Conventionally, once the blood supply amount is set in accordance with the above-described conditions for each blood donor, an air pressure is set so as to obtain the set blood supply amount, and thereafter, the pressure is set. The value could not be changed.

[0005] Further, since no detection means such as a flow meter for grasping the amount of blood returned was provided, it was not possible to know the exact amount of blood returned for controlling the flow of blood. It is preferable that the blood return flow rate is kept constant at an appropriate value. However, it has been conventionally difficult to maintain the blood return flow rate appropriately and stably for the reasons described above.

[0006]

SUMMARY OF THE INVENTION An object of the present invention is to provide a plasma separation apparatus capable of appropriately controlling a blood supply flow rate.

[0007]

This and other objects are achieved by the present invention described below (1), and (2) to (5).
It is preferred that

(1) A blood collection bag, a plasma collection container,
The blood collection bag and the plasma collection container are connected, a plasma separation device to which a plasma collection circuit including a plasma separator having a blood return line is attached, wherein the plasma separation device includes a storage unit for the blood collection bag. A pressurizing unit capable of pressurizing the inside of the storage unit, and a flow rate detecting unit configured to detect a blood flow rate of a blood return line in the plasma collection circuit, based on the detected blood flow rate of the blood return line. A blood flow rate of the blood return line is controlled by the pressurizing means.

(2) The flow rate detecting means is constituted by weight detecting means for detecting the weight of the blood collection bag and / or the plasma collection container, and based on the amount of change in weight detected by the weight detecting means. The plasma separation device according to the above (1), wherein the blood supply flow rate of the blood return line is detected and the blood supply flow rate is controlled.

[0010] (3) The plasma according to (2) above, wherein the blood supply flow rate of the blood return line is obtained by subtracting an increase change amount of the plasma collection container from a decrease change amount of the blood collection bag. Separation device.

(4) The plasma separation apparatus according to any one of (1) to (3), wherein the control of the blood supply flow rate in the blood return line is performed by adjusting the pressure in the storage section.

(5) The plasma separation apparatus according to any one of (1) to (4), wherein the pressurizing means also has a function of reducing the pressure in the storage section.

[0013]

The blood collected in the blood collection bag is stored in the storage section, and is sent to the plasma separator by increasing the pressure in the storage section by the pressurizing / depressurizing means. In the plasma separator, plasma and blood cell components are separated, the plasma is sent into a plasma collection container, and the blood cell components are returned to the donor via a blood return line.

The blood flow is controlled by adjusting the pressure applied within the container. Further, the blood supply flow rate, which is a control amount, is detected by the flow rate detecting means, and the pressure in the storage section is adjusted based on the detected value, and the blood supply flow rate is feedback-controlled. Such flow control is
The present invention is not limited to the control of the blood return flow rate, and can be used for the flow rate of liquid supply to other containers or devices such as a plasma collection container.

[0015]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Preferred embodiments of the present invention will be described below with reference to the accompanying drawings. FIG. 1 is a schematic diagram illustrating a basic configuration of a plasma collection device 1 according to the present embodiment. Also, FIG.
1 is an overall perspective view of a plasma collection device 1 to which a plasma collection circuit is attached.

The plasma collection device 1 is a decompression / pressurization type plasma separation device in which whole blood once collected in a blood collection bag by vacuum blood collection is separated by a plasma separator by pressurizing the blood collection bag at a constant pressure. .

The plasma collection circuit 2 attached to the plasma collection apparatus 1 mainly includes a blood collection bag 21, a plasma separator 22, and a plasma collection container 23. For example, the blood collection bag 21 is formed by stacking resin-made flexible sheet materials and fusing (heat fusing, high frequency fusing, or the like) or adhering them into a bag shape at the peripheral sealing portion. be able to. The blood collection bag 21 is connected to the other end of the liquid sending pipe 31 whose one end is branched into three. A blood collection needle 211 is connected to a first branch end of the branched liquid sending pipe 31 to form a blood collection line, and a puncture needle that is punctured into the anticoagulant bag 24 is connected to a second branch end. ing. The blood inlet 2 of the plasma separator 22 is located at the third branch end.
21 are connected. The liquid supply pipe has flexibility and flexibility, and is made of a material such as a thermoplastic elastomer, and can be made of, for example, polyvinyl chloride.

As the plasma separator 22, a hollow fiber membrane type, a flat membrane type, or the like is used. The inflowing blood is separated into a plasma component and a blood cell component by contacting the hollow fiber membrane, the flat membrane, or the like. The separated blood flows out of the plasma outlet 222 and the blood cell component flows out of the blood cell outlet 223. One end of a liquid sending tube 32 is connected to the blood cell outlet 223, and the other end is connected to a liquid sending tube connected to the blood collection needle 211. A blood return line is configured by such a liquid feeding tube 32 and the blood collection needle 211.

On the other hand, the plasma outlet 222 is
Is connected to one end, and a plasma collection container 23 is connected to the other end. The plasma collection container 23 can be a bag such as a blood collection bag, for example.

The plasma collection circuit configured as described above
It is attached to the plasma collection device 1 described below. FIG.
Has a storage section 4 for storing a blood collection bag 21. The accommodation section 4 includes an accommodation section 4
The pressurizing / depressurizing means 41 for adjusting the air pressure in the inside is connected. The pressurizing / depressurizing means 41, as shown,
It comprises an air supply / exhaust circuit 42 communicating with the inside of the housing part 4, a vacuum pump 43, two three-port switching valves 44a and 44b, and a leak valve 44c. These valves are electromagnetic valves and are electrically opened and closed.
The three-port switching valves 44a and 44b switch between a ventilation state and a state in which the circuit on the vacuum pump 43 side is opened to the atmosphere. The leak valve 44c switches between a ventilation state and a closed state.

Further, the blood collection bag 2
1 is provided with a rocking means 45 for shaking 1, a first weight detecting means 46 for detecting the weight of the blood collection bag 21, and a pressure detecting means 47 for detecting the pressure in the storage section 4.

The oscillating means 45 comprises a box-shaped accommodation table 212 for accommodating the blood collection bag 21, an oscillating crank for oscillating the same, and an oscillating motor for driving the oscillating crank. . And the accommodation table 212
The tilt angle in the standby state and the stop state is +2 with respect to the horizontal
It is set to 0 ° (so as to be inclined forward), and is configured to swing at an amplitude of ± 20 ° with respect to the horizontal while the swing motor is being driven. Further, the pressure detecting means 47
For example, a diffusion type semiconductor pressure detecting means can be used.

The accommodation section 4 is arranged above the plasma collection device 1. Then, by opening the lid 48 provided on the upper surface of the plasma collection device 1, the housing portion 4 is opened.
The sealing means is released, and the rocking means 4 provided inside is
The blood collection bag 21 can be placed on the fifth storage table 212. From the blood collection bag 21 housed in the housing part 4, a liquid feed pipe 31 is led out to the front side, and is connected to a blood inlet 221 of the plasma separator 22, which is set, which will be described later.

The plasma collection device 1 includes a plasma separator 22
And a mounting portion 5 for mounting the same. Plasma separator 22
Is attached to the attachment part 5 so that the blood inlet 221, the plasma outlet 222, and the blood cell outlet 223 face the front side. As described above, since the connection port of the liquid feed pipe 3 is arranged on the front side, the connection work of the liquid feed pipe and the like can all be completed at the front position.

Further, the plasma collection device 1 has second weight detecting means 6 for mounting the plasma collection container 23 and detecting the weight of the plasma collection container 23. As the first and second weight detecting means, for example, a level sensor using ultrasonic waves or light for detecting the capacity of the load cell or the container can be used.

Further, on the front side of the plasma collection device 1, there is provided a circuit opening / closing means 7 through which a liquid supply pipe connected to each of the above-mentioned parts is inserted.
1, 72, 73 and 74 are arranged. As this circuit opening / closing means, for example, a solenoid / pinch valve which is closed in a normal state is used. The circuit opening / closing means controls the flow of liquid in the tube by pressure-closing and releasing the liquid sending tube made of the flexible tube from the outside. An anticoagulant bag hanger 11 is provided upright on the right side of the plasma collection device 1.

The above-described vacuum pump 43, three-port switching valves 44a, 44b, pressure detecting means 47, first weight detecting means 46, second weight detecting means 6, and circuit opening / closing means 71, 7
2, 73 and 74 are electrically connected to the control means 8.

Further, the control means 8 is also connected to an input panel 9 arranged on the front side of the plasma collection device 1. Note that a compression pump 121 for adjusting the pressure of the cuff 12, an air valve 122, and a pressure sensor 123 are provided, and these are also connected to the control means 8.

The blood cell outlet 223 of the plasma separator 22
Is provided with a bubble detecting means 321. As the bubble detecting means 321, an ultrasonic bubble sensor can be used.

The operation of the plasma collection apparatus 1 described above will be briefly described. After the plasma collection circuit 2 is attached to the plasma collection apparatus 1, a blood collection needle 211 is punctured into the blood donor's body.
Blood is collected in the blood collection bag 21. A predetermined amount (for example, 200 ml,
(400 ml, etc.) When the blood is collected, the blood collection is stopped, the circuit opening / closing means 71 through which the liquid supply tube constituting the blood collection line is inserted is closed, and the liquid supply tube connected to the anticoagulant bag 24 is inserted. The circuit opening / closing means 72 is opened. By lowering the air pressure in the storage section 4, the anticoagulant is
Introduce within. After introducing a predetermined amount of the anticoagulant, the circuit opening / closing means 72 is closed and the circuit opening / closing means 71 is opened, the air pressure in the storage section 4 is slightly raised, and the blood is returned to the blood collection line to perform anticoagulation treatment.

The circuit opening / closing means 71 is closed again, the circuit opening / closing means 73 is opened, the air pressure in the container 4 is increased, and the blood in the blood collection bag 21 is sent to the plasma separator 22. In the plasma separator 22, blood is separated into plasma and blood cell components,
The blood plasma is introduced into the blood plasma collection container 23, and the blood cell component is returned to the blood donor from the blood collection needle 211 through the blood return line. When the amount of blood in the blood collection bag 21 becomes equal to or less than the predetermined value, the leak valve 44c is opened to return the pressure in the storage unit 4 to the atmospheric pressure. When the blood sampling and plasma sampling operations are repeated, the above operation is repeated, and the operation is terminated when the amount of collected blood reaches the set value.

The above operations are performed by the vacuum pump 43, the three-port switching valves 44a and 44b, the pressure detecting means 47, the first weight detecting means 46, the second weight detecting means 6, the circuit opening / closing means 71, 72 and 73, 74 are controlled by the control means 8 respectively connected.

With the above-described plasma separation, the appropriate amount of blood returned to the donor depends on the condition of the donor. Specifically, the age, gender, blood pressure,
Determine the amount of blood returned taking into account weight, health status, etc. Then, the amount of blood returned is detected by the first weight detecting means 46 and 6 for the weight of the blood collection bag 21 and the weight of the plasma collection container 23 at predetermined time intervals, and the flow rate per unit time is calculated based on the amount of change. .

The flow rate from the blood collection bag 21 is calculated based on the value detected by the first weight detecting means 46. The amount of plasma flowing into the plasma collection container 23 is calculated based on the detection value of the second weight detecting means 6. Further, the blood return amount of the blood cell component returned to the donor is calculated by subtracting the increase in the weight of the plasma collection container 23 from the decrease in the weight of the blood collection bag 21. The amount of blood returned is divided by the predetermined time to determine the amount of blood returned per unit time. Such calculation is performed by the control means 8.

Therefore, the flow rate detecting means of the present embodiment
And the second weight detecting means 46 and 6 and the control means 8. Note that the blood return flow rate may be calculated in advance by calculating the ratio of plasma to blood cell components separated by the plasma separator 22 and calculating the plasma inflow amount and the blood return flow rate from the weight reduction amount of the blood collection bag 21. It is possible. Similarly, the plasma inflow amount and the blood return flow rate can be calculated from the weight increase amount of the plasma collection container 23. With such a configuration, the flow rate of each part can be detected by one weight detection unit, and the weight and size of the device can be reduced.

As described above, the circulation of blood and plasma as described above is caused by increasing the air pressure in the storage section 4 for storing the blood collection bag 21, but the flow rate of blood and the like is adjusted in the storage section 4. This is done by adjusting the air pressure of the air. The air pressure in the container 4 is -50 to
It can be set every 10 mmHg in the range of -200 mmHg, and can be set every 10 mmHg in the range of +50 to +200 mmHg in the pressurized state. Such pressure control is performed by turning on / off the vacuum pump 8. Switching between depressurization and pressurization is performed by setting one of the two three-port switching valves 44a and 44b to the ventilation state and the other to the atmosphere, and switching between them.

That is, if the switching valve 44a is opened to the atmosphere and the switching valve 44b is vented, the inside of the housing portion 4 is pressurized. If it is in the state,
The inside is decompressed.

The control means 8 includes circuit opening / closing means 71, 72,
73, 74 to control the liquid feeding direction, determine the start or stop of the liquid feeding or blood collection based on the detected weight of the blood collection bag, and furthermore, based on the detected value, the pressure in the storage section 4 is determined. Adjust the amount of liquid to maintain the appropriate amount.

The operation of the plasma collection device 1 according to the present invention will be briefly described below. The pre-primed plasma collection circuit 2 is mounted and set. Specifically, blood collection bag 2
1 is placed on the storage table 212 in the storage section 4 and the plasma separator 22 is
Are attached to the mounting portion 5, and the corresponding liquid sending pipes 31, 3
2 and 33 are mounted on the respective circuit opening / closing means 71 to 74, and the lid 48 of the storage section 4 is closed and locked. The housing portion 4 is kept airtight by the locking of the lid 48. Set the amount of blood collected at one time and the total amount of blood collected, and turn on the start switch.

First, in the anticoagulant injection mode, in order to inject a predetermined amount of the anticoagulant from the anticoagulant bag 24, the circuit opening / closing means 72 is opened, and the pressure in the housing portion 4 is reduced. Due to the difference between the pressure inside the storage unit 4 and the outside pressure,
An anticoagulant is injected into the blood collection bag 21. Accommodation table 212
Is placed on the first weight detecting means 46 constituted by a load cell, and is weighed at a constant cycle.
When the injection of the predetermined amount of the anticoagulant is completed, the circuit opening / closing means 72
Is closed, and the inside of the container 4 returns to the atmospheric pressure.

Next, the mode shifts to the puncturing standby mode.
After performing a predetermined operation such as priming of the connector connected to the blood collection line, the start switch presses the cuff 12. Here, the vein of the donor is punctured.

Next, the mode is shifted to the blood collection mode. When the start switch is pressed, the air in the storage section 4 is depressurized, and the circuit opening / closing means 71 opens to start blood collection. In order to stir the anticoagulant and the blood which have been injected in advance, the receiving table 212 is shaken at a constant cycle by the rocking means 45. When the weight of the blood collection bag 21 reaches a certain value by the first weight detection means 46, it is determined that the blood collection amount has reached a predetermined amount, the circuit opening / closing means 71 is closed, and the leak valve 44 is closed.
c is opened, and the container 4 is returned to the atmospheric pressure.

Next, the mode shifts to the small blood return mode. Accommodation part 4
The inside is pressurized, the circuit opening / closing means 71 opens, and the anticoagulated blood in the blood collection bag 21 flows to the blood collection line to perform anticoagulation processing on the line. When the weight of the blood collection bag 21 decreases by a predetermined amount, the circuit opening / closing means 71 closes and the mode shifts to the next mode.

The circuit opening / closing means 73 is opened while the inside of the storage chamber 4 is pressurized, and the physiological saline in the plasma separator 22 is first drained. When the weight of the blood collection bag decreases by a predetermined amount, the circuit opening / closing means 73 is closed, and the circuit opening / closing means 74 is opened,
The separated blood return mode is started.

During the separated blood return mode, the blood return flow rate is controlled as follows. FIG. 3 shows the control operation of the liquid sending flow rate.
The flowchart is shown in FIG. This will be described in detail below with reference to FIG.

It is determined whether a predetermined time has elapsed since the previous flow control. If not, return to the calling routine. If the time has elapsed, it is determined whether or not blood is being returned (specifically, when the circuit opening / closing means 73 is open and the air pressure in the storage unit 4 is higher than the atmospheric pressure). If not, return to calling routine.
When blood is being returned, the weight of the blood collection bag 21 is detected. Further, the weight of the plasma collection container 23 is detected. And weight of the detected blood collecting bag 21, from the weight of the plasma collection container 23, and calculates the blood return flow rate Q _1.

The input panel 9 sets an upper limit and a lower limit that are acceptable as the blood return flow rate, and determines whether the calculated flow rate Q falls within the upper and lower limit values, and If it is outside, the pressure in the storage section 4 is adjusted to control the flow rate.

[0048] That is, when the upper limit <Q ₁ returns the pressure in the housing portion 4 constant value P ₁ is lowered to the calling routine. Upper limit <If not Q ₁ is further lower limit> Q ₁
Whether the determined, if the lower limit value> Q ₁ returns the pressure in the housing portion 4 fixed value P ₂ raised to the calling routine. If it is not the lower limit value> Q _1, the process returns as it is to the calling routine.

This routine is repeated every predetermined time. The interval at which this control operation is repeated may be about 5 to 60 seconds, for example, about 20 seconds.

The specific upper and lower limits vary depending on the age and sex of the donor, but generally the upper limit is about 80 to 200 ml / min, and the lower limit is 0 to 60 ml / min. / Min. Furthermore, adjusting the fluctuation width P ₁ of the housing portion 4 inside pressure, 5～50MmHg about in what capacity to accommodate the blood collecting bag of 400 ml, P ₂ is, 5～50MmHg
Degree is fine.

If the blood collection bag 21 becomes empty before the weight of the blood plasma collection container 23 reaches the predetermined set value during the blood return, the operation is repeatedly performed from the blood collection mode. The next blood collection amount is calculated from the already collected blood amount, and this value is set as the blood collection amount in the next cycle.

When the set blood collection amount is reached in the middle of the separated blood return mode, the blood collection is interrupted at that time, the circuit opening / closing means 71 is opened, and the blood is returned to the donor from the blood collection line.
When the weight of the blood collection bag 21 reaches a predetermined threshold value or less, the circuit opening / closing means 71 is closed to end the blood collection.

The structure for detecting the weight of the blood collection bag 21 is as follows.
In the case where the pressure sensor is arranged on the bottom surface of the housing 212, the drive of the rocking motor may be controlled so that the housing 212 is kept horizontal when the weight is detected.
This is because the error in detecting the weight due to the shaking of the storage table 212 is reduced, and the flow rate can be measured more accurately.

Further, as a means for reducing errors caused by shaking of the storage table 212, a method of detecting the weight of the storage table 212 to be shaken at a predetermined cycle, and detecting the inclination angle θ on the swing axis of the storage table 212. Is provided, and W ₀ = W ₁ / c based on the value W ₁ detected by the weight detecting means.
As osθ, a method of detecting the actual weight W ₀ or the like may be adopted.

The flow rate detecting means in the apparatus of the present embodiment
Since this method measures the weight of the blood collection bag 21 and the plasma collection container 23, problems such as hemolysis do not occur. Further, in this embodiment, since the average flow rate is calculated based on the weight detected every predetermined time, there is an advantage that there is little variation in the detected value and stable flow control can be performed. In addition to the method of calculating from the detected weight as described above, a method of providing a flow meter in the middle of the liquid feeding pipes 31, 32, and 33 and measuring the control amount by the flow meter may be used as the flow rate detecting means. Good. As another example of the flow meter, a flow meter that irradiates light to the tube and optically detects the flow in the tube may be used.

The plasma collection apparatus of the present invention having the above-described configuration can change the blood return flow rate during the plasma separation and blood return operations in some cases, and can adjust the blood return flow rate according to the condition of the donor. Adjustment is also possible, and safer blood sampling can be performed quickly.

[0057]

As described above, according to the plasma collection apparatus of the present invention, by controlling the amount of blood returned, the plasma collection and blood return can be performed safely and quickly. is there.

[Brief description of the drawings]

FIG. 1 is a schematic diagram showing a basic configuration of a plasma collection device of the present embodiment.

FIG. 2 is an overall perspective view of a plasma collection device provided with a plasma collection circuit.

FIG. 3 is a flowchart in blood flow control.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Plasma separation apparatus 2 Plasma collection circuit 21 Blood collection bag 211 Blood collection needle 212 Storage table 22 Plasma separator 221 Blood inlet 222 Plasma outlet 223 Blood cell outlet 23 Plasma collection container 24 Anticoagulant bag 31 Liquid supply pipe 32 Liquid supply pipe 321 Bubble detecting means 33 Liquid sending pipe 4 Storage section 41 Pressurizing / depressurizing means 42 Sending / exhausting circuit 43 Vacuum pump 44a, b 3-port switching valve 44c Leak valve 45 Swing means 46 First weight detecting means 47 Pressure detecting means 48 Lid 5 Mounting part 6 Second weight detecting means 71 to 74 Circuit opening / closing means 8 Control means 9 Input panel 11 Hanger for anticoagulant bag 12 Cuff 121 Compression pump 122 Air valve 123 Pressure sensor

──────────────────────────────────────────────────続 き Continuation of the front page (56) References JP-A-63-115569 (JP, A) JP-A-2-98365 (JP, A) (58) Fields investigated (Int. Cl. ⁷ , DB name) A61M 1/02-1/36

Claims (1)

(57) [Claims] 1. A plasma separation apparatus to which a plasma collection circuit including a blood collection bag, a plasma collection container, and a plasma separator connected to the blood collection bag and the plasma collection container and having a blood return line is attached. The plasma separation device includes a storage section of the blood collection bag, a pressurizing unit that can pressurize the storage unit, and a flow detection unit that detects a blood supply flow rate of a blood return line in the plasma collection circuit. A plasma separation device, wherein the blood pressure in the blood return line is controlled by the pressurizing means based on the detected blood flow in the blood return line.