JPH0470029B2 - - Google Patents

Description

[Detailed Description of the Invention] <Industrial Application Field> The present invention collects blood from a blood donor into a blood bag, measures the weight of the blood bag, and returns the blood when the amount of collected blood reaches a certain amount. In a plasma collection device that separates plasma from blood between blood collection and blood return operations,
The present invention relates to a plasma sampling device that measures the tare weight of blood bags exchanged every time blood samples are collected, and can accurately measure the blood weight regardless of variations in the tare weight of the blood bags.

<Prior Art> Plasma fractionation agents (separated and purified plasma components) are used in large quantities for various treatments. Most of it relies on imports. With the current method of blood collection, the maximum amount of blood that can be collected at one time is 200 milliliters. According to a method that collects only plasma and returns blood cell components to the donor, even if twice the current amount is collected, there will be no effect on the human body. Therefore, consideration is being given to collecting plasma using such a method and increasing the domestic plasma self-sufficiency rate.

The conventional method for separating plasma is to add an anticoagulant (hereinafter referred to as ACD solution) to the blood collected from the donor.
is added, and the plasma is separated from the plasma using a centrifugal separator.However, when using such a centrifugal separation method, the equipment is expensive and the plasma collection process takes a long time.

Recently, a separation membrane has been developed that uses hollow fibers with small holes in a straw-like polymer membrane with a hollow interior.If this separation membrane is used, a serum sampling device can be constructed at low cost. The time required for serum collection work can also be shortened.

In such a membrane separation type plasma collection device, blood is collected and blood is returned many times to collect plasma, thereby obtaining, for example, 400 milliliters of plasma from the blood donor.

In this case, the conventional apparatus for measuring the amount of blood collected at one time was as shown in FIG. In the figure, 2
0 is a detector housing, 21 is a blood bag, and 22 is a blood circuit. Inside the housing 20, 20a is a cantilever whose one end is fixed to the support part 20b;
0c is a bias spring provided between the housing 20 and the cantilever 20a, 20d is a hook connected near the tip of the cantilever 20a, and the housing 2
A blood bag 21 is suspended from the tip extending outward from the blood bag 21. 20e and 20f are cantilever 2
This is a limit switch that opens and closes according to the movement of the tip of 0a.

With this configuration, blood is guided to the blood bag 21 via the blood circuit 22. cantilever 20
The cantilever 20a is bent according to the weight of the blood bag 21, and the cantilever 20 is connected to a limit switch 20f that is preset according to the upper limit of blood weight that can be collected at one time.
When the tip of a contacts, blood collection is stopped and blood return is started.

As the blood is returned, the weight of the blood bag 21 becomes lighter, and when the tip of the cantilever 20a contacts the limit switch 20e, which has been set in advance to correspond to the lower limit of the weight of the blood bag 21, the blood return is stopped and blood collection starts again. be done.

Such blood collection and blood return are repeated until the target amount of collected plasma is obtained.

However, in such a system, the upper and lower limit setting values are fixed values determined by the positions of the limit switches 20e and 20f. On the other hand, there is variation in the tare weight of the blood bag 2 suspended from the hook 20d, and in such a method, an error occurs at the zero point when measuring the blood weight.

<Problems to be Solved by the Invention> The first technical problem to be solved by the present invention is to prevent the error at the zero point from occurring;
The second technical problem to be solved by the present invention is to provide a membrane separation type blood sampling device that can accurately measure blood weight regardless of variations in the tare weight of the blood bag. It is an object of the present invention to provide a membrane separation type plasma sampling device which is suitable for a plasma sampling device and is equipped with a weight detector for measuring the blood bag.

<Means for Solving the Problems> The first aspect of the present invention is to collect a certain weight of blood from a donor, return the blood, and separate plasma from the blood between the blood collection and return. A single needle 1 used for both blood collection and blood return punctured into donor A.
2c, B blood circuit B with one end connected to the single needle 12c and the other end connected to the blood bag 3 described later; C one connection port connected to blood circuit B and the other connection port connected to the rear blood bag 3; A blood bag 3 connected to the output blood circuit C; D A clamp 8a provided in the blood circuit B and opened during blood sampling operation and closed during subsequent air discharge; E Blood bag 3 Weight detector 1 that detects the weight of
4 and F are provided in the blood circuit B, and are driven in the forward direction until the weight of the blood bag 3 reaches a certain upper limit value during blood sampling operation, and until the weight of the blood bag 3 reaches a certain lower limit value from the upper limit value. , driven in the opposite direction,
A blood pump 7b that repeatedly collects blood and returns blood; blood circuit C; H blood pump 7c provided in blood circuit C and driven continuously during plasma collection operation to flow blood in the circuit in one direction; I blood circuit side and plasma circuit side separated by a separation membrane. a separator 13 whose blood circuit side is connected to the blood circuit C; a plasma circuit whose one end is connected to one opening of the plasma circuit side of the J separator 13 and whose other end is connected to the plasma bag 4 described later; K: an air pump 7d which is provided at the other mouth of the separator 13 on the plasma circuit side and is driven during the priming operation to discharge air present in the blood bag 3 and the circuit from this bag; L: the blood in the separator 13 A pressure gauge 9c detects the pressure on the circuit side; M A pressure gauge 9d detects the pressure on the plasma circuit side of the separator 13; O A plasma bag 4 provided downstream of the plasma collection pump 7e and storing plasma; P One end connected to the blood circuit C between the separator 13 and the blood bag 3; Drainage bag 5
A drain circuit connected to Q, a clamp 8e provided in this drain circuit and closed during serum collection operation and air discharge, R downstream from the connection with the drain circuit. A clamp 8d is provided in the blood circuit C on the side and is opened during blood sampling operation and air evacuation; A control unit D that resets the upper and lower limit set values of the blood bag 3 based on the stored signals and controls the blood pump 7b based on the newly set upper and lower limit values during the blood sampling operation, Before starting the blood sampling operation, the air pump 7d was driven to empty the blood bag 3 and measure the tare weight of the blood bag, thereby eliminating measurement errors in blood weight due to changes in the tare weight of the blood bag 3. That's what it is.

The configuration of the second invention of the present invention is a plasma collection device that collects a certain weight of blood from a blood donor, returns the blood, and separates plasma from the blood between the blood collection and the blood return, A blood donor A Single needle for blood collection and blood return 1
2c, B blood circuit B with one end connected to the single needle 12c and the other end connected to the blood bag 3 described later; C one connection port connected to blood circuit B and the other connection port connected to the rear blood bag 3; A blood bag 3 connected to the output blood circuit C; D A clamp 8a provided in the blood circuit B and opened during blood sampling operation and closed during subsequent air discharge; E Inside the main body Cantilever 1 on the provided fulcrum
A weight detector 14 that suspends a blood bag 3 from the free end of a cantilever 14a, one end of which is fixed, protrudes from the front surface of an operation panel 15, and detects the weight of the blood bag 3 based on the displacement of the cantilever 14a; It is provided in circuit B, and is driven in the forward direction until the weight of the blood bag 3 reaches a certain upper limit value during blood sampling operation, and is driven in the reverse direction until the weight of the blood bag 3 reaches a certain lower limit value from the upper limit value. is,
A blood pump 7b that repeatedly collects blood and returns blood; blood circuit C; H blood pump 7c provided in blood circuit C and driven continuously during plasma collection operation to flow blood in the circuit in one direction; I blood circuit side and plasma circuit side separated by a separation membrane. a separator 13 whose blood circuit side is connected to the blood circuit C; a plasma circuit whose one end is connected to one opening of the plasma circuit side of the J separator 13 and whose other end is connected to the plasma bag 4 described later; K: an air pump 7d which is provided at the other mouth of the separator 13 on the plasma circuit side and is driven during the priming operation to discharge air present in the blood bag 3 and the circuit from this bag; L: the blood in the separator 13 A pressure gauge 9c detects the pressure on the circuit side; M A pressure gauge 9d detects the pressure on the plasma circuit side of the separator 13; O A plasma bag 4 provided downstream of the plasma collection pump 7e and storing plasma; P One end connected to the blood circuit C between the separator 13 and the blood bag 3; Drainage bag 5
A drain circuit connected to Q, a clamp 8e provided in this drain circuit and closed during serum collection operation and air discharge, R downstream from the connection with the drain circuit. A clamp 8d is provided in the blood circuit C on the side and is opened during blood sampling operation and air evacuation; A control unit D that resets the upper and lower limit set values of the blood bag 3 based on the stored signals and controls the blood pump 7b based on the newly set upper and lower limit values during the blood sampling operation, Before starting the blood sampling operation, the air pump 7d was driven to empty the blood bag 3 and measure the tare weight of the blood bag, thereby eliminating measurement errors in blood weight due to changes in the tare weight of the blood bag 3. There is a particular thing.

<Examples> Examples of the present invention will be described below with reference to the drawings. FIG. 1 is a block diagram of an apparatus according to an embodiment of the present invention. In the figure,
A is a blood donor, B is a blood circuit through which the blood from this donor flows, 1 is an ACD fluid bag that stores ACD fluid, 2a and 2b are saline bags that store physiological saline, and 3 is a saline bag that stores physiological saline. C is a blood circuit that circulates through the inner chamber of the separator and blood bag 3, which will be described later; 4 is a plasma bag that stores plasma separated from the collected blood; 5
6a to 6f are drainage bags that store drainage fluid, and 1st to 6f to detect each fluid (ACD fluid, physiological saline, etc.)
The sixth detector, 7a to 7e, is an ACD liquid supply pump that supplies fluid (blood, air, etc.);
Among the second blood pump, air pump, and serum sampling pump, the first blood pump 7b and air pump 7d can be driven in both forward and reverse directions.

8a to 8g are first to seventh clamps that open and close the respective flow paths through which the respective fluids flow; 9a to 9d are first to fourth pressure gauges; 10a to 10c are first to third chambers; 11a and 11b are blood detectors and hemolysis detectors, respectively, 12a to 12c are first to third
The needle 13 is, for example, a separator in which a large number of hollow fibers, each made of a hollow straw-like polymer membrane with small holes, are bundled together and placed in a cylindrical container, with the inside of each hollow fiber forming an inner chamber. An outer chamber is formed by the outer side and the cylindrical container. Blood flows into this inner chamber.

A weight detector 14 detects the weight of the blood bag 3, and has a cross section as shown in FIG. In the figure,
15 is a main body operation panel, and one end of a cantilever 14a of the weight detector 14 is supported by a support portion 14b fixed to the back surface of the panel inside the main body. The other end of the cantilever 14a projects to the front surface of the panel 15 through an opening 15a provided in the panel 15, and the blood bag 3 is suspended from the tip hook. The weight of the blood bag 3 is measured by detecting the deflection of the cantilever 14a using a strain gauge 14c attached to a portion of the cantilever 14a near the fulcrum.

A part D surrounded by a dashed line is a control part, and includes a multiplexer ( MPX) 16a, this
A/D converter for analog signals from MPX
D converter 16b, central processing unit (CPU) 1
6c, a random access memory (RAM) 16d that temporarily stores read data, a read-only memory (ROM) 16e that stores processing routines, arithmetic processing programs, etc., and a CPU 16.
ACD liquid supply pump 7a, first and second blood pumps 7
b, 7c, air pump 7d, and serum sampling pump 7
D/ which outputs a drive signal (the number inside the box corresponds to the code of the part to which the output is given) to e.
An A converter 16f is included, and each of these elements except for the MPX 16a are connected to each other via a bus (BUS) 16g.

Next, the operation of the apparatus according to the embodiment of the present invention configured as described above will be explained. First, the measurement of the tare weight of the blood bag 3, which is a feature of the present invention, will be explained. The priming operation is performed as follows. First, third and fourth clamps 8c, 8d
is open and the remaining clamps 8a, 8b, 8e, 8f,
8g is in the closed state, the second and third needles 12b, 12
c are punctured into the saline bags 2a and 2b, respectively, and the air pump 7d is driven. The air present in the blood bag 3 and in the flow path from this bag to the air pump 7d is sucked. And the third pressure gauge 9c
When the pressure reaches a predetermined negative pressure (-PmmHg), the air pump 7d is stopped.

In this state, the weight of blood bag 3 is detected by weight detector 1.
4 and is input to the control section D as a signal representing the tare weight of the blood bag 3. Based on this tare weight signal, the upper and lower limit values of the blood bag 3 are zero-corrected, and in the operating operation described later, blood is returned and blood is collected based on the upper and lower limit set values.

In addition to the operations of the characteristic parts of the invention, the apparatus according to the embodiment of the invention operates as follows. That is, after this,
The second clamp 8b, the fifth clamp 8e, the sixth clamp 8f, and the seventh clamp 8g are opened, and the second blood pump 7c is driven. This pump is driven to remove air present in the flow path through which physiological saline flows, and the third detector (physiological saline detector) 6c starts operating for a certain period of time (usually 1 to 2 seconds), the second clamp 8b is closed.

After that, the first clamp 8a is opened and the ACD
The liquid supply pump 7a and the first blood pump 7b are driven. This ACD liquid supply pump 7a is driven to remove air present in the flow path through which the ACD liquid flows, and for a certain period of time after the first detector (ACD liquid detector) 6a starts operating. After the elapse of (usually 1 to 2 seconds), the ACD liquid supply pump 7a is stopped.

After that, the separator 13 is detected by the fourth detector 6d.
After a certain period of time (usually several seconds) has elapsed since the detection of the liquid level, the sixth clamp 8f is closed, and the liquid level in the second chamber (separator inlet chamber) 10b is determined. Similarly, the fifth detector 6e detects the liquid level at the outlet of the separator 13, and after a certain period of time (usually several seconds) has elapsed since the liquid level was detected, the seventh clamp 8g is closed and the third chamber (separator outlet The liquid level of chamber) 10c is determined.

When the saline solution flows from the saline bag 2a, the air pump 7d is driven and the separator 13
A negative pressure is applied to the outside of the separation membrane, and physiological saline is introduced to the outside of the separation membrane. The sixth detector 6f detects that this area is filled with physiological saline, and the air pump 7
d in the opposite direction. By driving the air pump 7d in this manner, a positive pressure is applied to the outside of the separation membrane of the separator 13, and the physiological saline is guided to the inside of the separation membrane through the membrane of the separator 13. By repeatedly driving the air pump 7d in both forward and reverse directions, the blood circuit is cleaned using physiological saline.

Next, the operating operation will be explained according to the time chart shown in FIG. In this figure, figure a
Figure b shows the change in the total weight of blood bag 3, and Figure b shows the change in the total weight of blood bag 3.
Figure c shows the operating state of the liquid supply pump 7a.
Figure d shows the operating state of the second blood pump 7b, Figure e shows the operating state of the second blood pump 7b, and Figure e shows the operating state of the second blood pump 7b.
represents the operating state of e.

The third needle 12 that was inserted into the saline bag 2b
c is pulled out and stabbed into donor A's arm. Further, the first clamp 8a is opened, the ACD liquid supply pump 7a and the second blood pump 7c are driven, and the first blood pump 7b is driven in the forward direction.

The physiological saline that has been flowing into the blood circuit due to the priming operation is expelled by the blood supplied from donor A through the third needle 12c, and finally flows into the drainage bag 5. be discharged. When blood is detected by the blood detector 11a, the fifth clamp 8e is closed and the fourth clamp 8d is opened. Therefore, blood collected from donor A is stored in the blood bag 3. When blood begins to accumulate in the blood bag 3, the cantilever 14a shown in FIG. 2 bends due to the weight of the blood, and the total weight of the blood bag 3 detected by the strain gauge 14c is determined by the total weight of the blood bag 3, as shown in FIG. 3a. It gradually increases from the tare weight Gz.

When the total weight of the blood bag 3 reaches the upper limit set value Gu, the ACD liquid supply pump 7a is stopped and the first
The blood pump 7b is driven in the opposite direction to return blood.
Note that the second blood pump 7c is continuously driven at the same time as the start of the operating operation, and the serum sampling pump 7e is continuously driven from the time when the separator 13 becomes accustomed to the blood.

Due to blood return, the total weight of blood bag 3 decreases,
When the lower limit value Gl is reached, the first blood pump 7b is switched and driven in the forward direction, and the ACD liquid supply pump 7
a is redriven.

Such blood collection and blood return are repeated until the target amount of collected plasma is obtained. Immediately after the time te has elapsed and the target sample amount has been reached, the first blood pump 7
b is driven in the opposite direction to begin blood return operation. The second blood pump 7c continues to be driven until the weight signal detected by the weight detector 14 reaches the tare weight Gz of the blood bag 3.

<Effects of the Invention> According to the first aspect of the present invention, the air pump is driven before the start of the minimum operation (at the end of priming), the blood bag is emptied, and the tare weight of the blood bag is measured; Based on this measurement result, the upper and lower limits of the blood bag are reset for each minimum movement, so the blood volume in extracorporeal circulation can be accurately controlled regardless of variations in the tare weight of the blood bag. This will prevent you from forcing yourself or putting yourself in a dangerous situation.

According to the second aspect of the present invention, in addition to the effects of the first aspect, since the blood bag is directly hooked onto the cantilever type weight detector protruding from the front surface of the panel for measurement, the fluctuation of the blood bag can be improved. No measurement error occurs even if there is a disturbance such as. For this reason,
It is also possible to set the lower limit of the amount of blood to be collected to zero grams, and the amount of extracorporeal blood circulation can be minimized.

In the apparatus according to the embodiment of the present invention, the pulsations of various pumps may be superimposed on the output of the weight detector 14, but the influence of such noise components can be eliminated by the data averaging process in the control section D. It can be easily removed. Furthermore, an operator may accidentally touch the blood bag 3 and greatly disturb the output of the weight detector 14, but such disturbances are treated as noise unless they last for a certain period of time and are calculated so as not to be used as data. Can be easily removed by processing.

[Brief explanation of drawings]

FIG. 1 is a block diagram of the apparatus according to the embodiment of the present invention, FIG. 2 is a sectional view of a weight detector used in the apparatus according to the embodiment of the present invention shown in FIG. 1, and FIG. FIG. 4 is a schematic diagram showing a conventional example of a blood bag weight detector. A...Blood donor, B, C...Blood circuit, D...Control unit,
1...ACD liquid bag, 2a, 2b...raw food bag,
3...Blood bag, 4...Plasma bag, 7a...ACD
Liquid supply pump, 7b, 7c...first and second blood pumps, 7d...air pump, 7e...serum sampling pump,
9a-9d...pressure gauge, 12a-12c...needle, 13
...Separator, 14...Weight detector, Gz...Tare weight of blood bag 3, Gu...Upper limit value, Gl...Lower limit value.

Claims (1)

[Scope of Claims] 1. A plasma collection device that collects a certain weight of blood from a blood donor, returns the blood, and separates plasma from the blood between the blood collection and the return; Single needle 1 for blood return
2c, B blood circuit B with one end connected to the single needle 12c and the other end connected to the blood bag 3 described later; C one connection port connected to blood circuit B and the other connection port connected to the rear blood bag 3; A blood bag 3 connected to the output blood circuit C; D A clamp 8a provided in the blood circuit B and opened during blood sampling operation and closed during subsequent air discharge; E Blood bag 3 Weight detector 1 that detects the weight of
4 and F are provided in the blood circuit B, and are driven in the forward direction until the weight of the blood bag 3 reaches a certain upper limit value during blood sampling operation, and until the weight of the blood bag 3 reaches a certain lower limit value from the upper limit value. , driven in the opposite direction,
A blood pump 7b that repeatedly collects blood and returns blood; blood circuit C; H blood pump 7c provided in blood circuit C and driven continuously during plasma collection operation to flow blood in the circuit in one direction; I blood circuit side and plasma circuit side separated by a separation membrane. a separator 13 whose blood circuit side is connected to the blood circuit C; a plasma circuit whose one end is connected to one opening of the plasma circuit side of the J separator 13 and whose other end is connected to the plasma bag 4 described later; K: an air pump 7d which is provided at the other opening of the separator 13 on the plasma circuit side and is driven during the priming operation to discharge air present in the blood bag 3 and the circuit from this bag; L: the blood in the separator 13 A pressure gauge 9c detects the pressure on the circuit side; M A pressure gauge 9d detects the pressure on the plasma circuit side of the separator 13; O A plasma bag 4 provided downstream of the plasma collection pump 7e and storing plasma; P One end connected to the blood circuit C between the separator 13 and the blood bag 3; Drainage bag 5
A drain circuit connected to Q, a clamp 8e provided in this drain circuit and closed during serum collection operation and air discharge, R downstream from the connection with the drain circuit. A clamp 8d is provided in the blood circuit C on the side and is opened during blood sampling operation and air evacuation; A control unit D that resets the upper and lower limit set values of the blood bag 3 based on the stored signals and controls the blood pump 7b based on the newly set upper and lower limit values during the blood sampling operation, Before starting the blood sampling operation, the air pump 7d was driven to empty the blood bag 3 and measure the tare weight of the blood bag, thereby eliminating measurement errors in blood weight due to changes in the tare weight of the blood bag 3. A plasma sampling device characterized by: 2. A plasma collection device that collects a certain weight of blood from a blood donor, returns the blood, and separates plasma from the blood between blood collection and blood return. Needle 1
2c, B blood circuit B with one end connected to the single needle 12c and the other end connected to the blood bag 3 described later; C one connection port connected to blood circuit B and the other connection port connected to the rear blood bag 3; A blood bag 3 connected to the output blood circuit C; D A clamp 8a provided in the blood circuit B and opened during blood sampling operation and closed during subsequent air discharge; E Inside the main body Cantilever 1 on the provided fulcrum
A weight detector 14 that suspends a blood bag 3 from the free end of a cantilever 14a, one end of which is fixed, protrudes from the front surface of an operation panel 15, and detects the weight of the blood bag 3 based on the displacement of the cantilever 14a; It is provided in circuit B, and is driven in the forward direction until the weight of the blood bag 3 reaches a certain upper limit value during blood sampling operation, and is driven in the reverse direction until the weight of the blood bag 3 reaches a certain lower limit value from the upper limit value. is,
A blood pump 7b that repeatedly collects blood and returns blood; blood circuit C; H blood pump 7c provided in blood circuit C and driven continuously during plasma collection operation to flow blood in the circuit in one direction; I blood circuit side and plasma circuit side separated by a separation membrane. a separator 13 whose blood circuit side is connected to the blood circuit C; a plasma circuit whose one end is connected to one opening of the plasma circuit side of the J separator 13 and whose other end is connected to the plasma bag 4 described later; K: an air pump 7d which is provided at the other mouth of the separator 13 on the plasma circuit side and is driven during the priming operation to discharge air present in the blood bag 3 and the circuit from this bag; L: the blood in the separator 13 A pressure gauge 9c detects the pressure on the circuit side; M A pressure gauge 9d detects the pressure on the plasma circuit side of the separator 13; O A plasma bag 4 provided downstream of the plasma collection pump 7e and storing plasma; P One end connected to the blood circuit C between the separator 13 and the blood bag 3; Drainage bag 5
A drain circuit connected to Q, a clamp 8e provided in this drain circuit and closed during serum collection operation and air discharge; R downstream from the connection with the drain circuit; A clamp 8d is provided in the blood circuit C on the side and is opened during blood sampling operation and air evacuation; A control unit D that resets the upper and lower limit set values of the blood bag 3 based on the stored signals and controls the blood pump 7b based on the newly set upper and lower limit values during the blood sampling operation, Before starting the blood sampling operation, the air pump 7d was driven to empty the blood bag 3 and measure the tare weight of the blood bag, thereby eliminating measurement errors in blood weight due to changes in the tare weight of the blood bag 3. A plasma sampling device characterized by: