JPH0547220B2 - - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION <Industrial Application Field> The present invention relates to a membrane separation type plasma collection device for separating plasma from blood collected from a blood donor.

<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.

However, even with such a membrane separation type blood sampling device, it still takes a considerable amount of time to collect the blood accumulated in the blood circuit, separator, and blood bag and return it to the blood donor. Ta.

<Problems to be Solved by the Invention> A technical problem to be solved by the present invention is that after the target plasma is collected in the membrane separation type plasma collection device, the blood circuit, the separator, and the blood bag are The purpose is to efficiently return accumulated blood to blood donors.

<Means for Solving the Problems> The plasma collection device of the first aspect of the present invention includes: A. A single needle punctured by a blood donor and used for blood collection and blood return B. One end is connected to the single needle, and the other end is connected to the single needle. A first blood circuit C connected to the blood bag. A second blood circuit D connected at one end to the first blood circuit and connected to the blood bag at the other end. A weight detector E for detecting the weight of the blood bag. It is installed in the blood circuit No. 1 and is driven in the forward direction until the weight of the blood bag reaches a certain upper limit during blood sampling operation, and is driven in the opposite direction until the weight of the blood bag reaches a certain lower limit from the upper limit. is,
A first pump F that repeatedly collects blood and returns blood. A second blood pump G that is installed in the second blood circuit and is driven in one direction during plasma collection operation to send the liquid in the circuit to the blood bag side. The blood circuit side and the plasma circuit side are separated by a separation membrane, and the blood circuit side is connected to a second blood circuit,
Separator H that separates plasma in blood from the blood circuit side to the plasma circuit side based on the pressure difference between the blood circuit side and the plasma circuit side Plasma circuit I connected to the plasma circuit side of the separator The blood circuit side of the separator and the plasma circuit Plasma bag K, which is installed downstream of the plasma collection pump and stores plasma; Saline bag L, which is connected to the second blood circuit and stores physiological saline. Saline bag Clamp 8b M is provided in the circuit connecting the first blood circuit and the second blood circuit, and is closed during the blood collection operation and opened during blood collection. It is provided at the connection part and is opened during the sample collection operation.
The clamp 8c is closed during blood collection.

The plasma collection device according to the second aspect of the present invention includes: A. A single needle punctured into a blood donor for both blood collection and blood return.B A first blood needle, one end of which is connected to the single needle and the other end connected to a blood bag. Circuit C A second blood circuit having one end connected to the first blood circuit and the other end connected to the blood bag D Weight detector E for detecting the weight of the blood bag E Provided in the first blood circuit to collect blood sample During operation, the first blood pump is driven in a direction to flow blood into the blood bag until the weight of the blood bag reaches a predetermined upper limit, and when the upper limit is reached, the first blood pump is stopped until the weight of the blood bag reaches a predetermined lower limit. F is provided in the second blood circuit, and is driven in a direction to discharge blood from the blood bag until the weight of the blood bag decreases to the lower limit value during blood sampling operation, and when the lower limit value is reached, the weight of the blood bag decreases. a second blood pump G that is stopped until it reaches the upper limit; the blood circuit side and the plasma circuit side are separated by a separation membrane; the blood circuit side is connected to the second blood circuit;
Separator H that separates plasma in blood from the blood circuit side to the plasma circuit side based on the pressure difference between the blood circuit side and the plasma circuit side.Plasma circuit I connected to the plasma circuit side of the separator.The blood circuit side of the separator and the plasma circuit. A plasma sampling pump J that forms a pressure gradient between the plasma sampling pump J and the plasma bag K that is installed downstream of the plasma sampling pump and stores plasma.In the first blood circuit, the blood bag side is closer to the connection part with the second blood circuit. A saline bag L for storing physiological saline connected to a saline bag L connected to the saline bag L for storing physiological saline; A clamp 8i that is provided in the circuit connecting the saline bag and the fourth blood circuit and is closed during blood sampling operation and opened during blood collection. M In the first blood circuit, a clamp 8h is provided between the connection part with the second blood circuit and the connection part with the saline bag, and is opened during blood collection operation and closed during blood collection. It is composed of

<Operation> The technical means described above operates as follows. In the first aspect of the present invention, after the blood sampling operation is completed, the first blood pump is driven in the opposite direction, the second blood pump is driven, and physiological saline is supplied from the second blood circuit to the separator and the blood bag. Collect the blood in the circuit by running water.

In the second aspect of the present invention, after the blood sampling operation is completed, the first and second blood pumps are simultaneously driven, and physiological saline is caused to flow from the first blood circuit to the separator and the blood bag to drain the blood in the circuit. to recover.

<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 first blood circuit through which blood from the donor flows, C is a second blood circuit in which blood circulates through the inner chamber of the separator and the blood bag 3, which will be described later.
1 is an ACD liquid bag that stores ACD liquid, 2
A and 2b are saline bags storing physiological saline, and the saline bag 2a is connected to a branch D provided in the second blood circuit C. 3 is a blood bag for storing collected blood, 4 is a plasma bag for storing plasma separated from the collected blood, 5 is a drainage bag for storing drainage fluid, and 6a to 6f are each fluid (ACD liquid, etc.). 1st to 6th to detect physiological saline, etc.)
Detectors 7a to 7e are ACD liquid supply pumps, first and second pumps, which supply fluid (blood, air, etc.).
blood pumps, air pumps and serum collection pumps,
Of these, 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 to 11c are blood detectors;
12a to 12c are first to third needles; 13 is a separator in which a large number of hollow fibers, each having a hollow straw-like polymer membrane with small holes, are bundled together and placed in a cylindrical container; The inside of the hollow fiber forms an inner chamber,
An outer chamber is formed by the outside and the cylindrical container.
In order to make it easier to understand, this part is shown as 1 in the diagram.
It is schematically expressed using the hollow threads of a book. A second blood circuit C is connected to this interior chamber. 14 is a weight detector for detecting the weight of the blood bag 3.

A part E surrounded by a dashed line is a control part, which includes a signal from the weight detector 14, a signal from the blood detector 1
A multiplexer (MPX) 15a that time-divisionally takes in signals from 1a to 11c or signals from the first to fourth pressure gauges 9a to 9d, and an A/D to A/D convert the analog signal from this MPX. converter 15
b, a central processing unit (CPU) 15c, a random access memory (RAM) 15d that temporarily stores read data, a read-only memory (ROM) 15e that stores processing routines, arithmetic processing programs, etc.; The digital signal is D/A converted and a drive signal is sent to the ACD liquid supply pump 7a, the first and second blood pumps 7b and 7c, the air pump 7d, and the serum sampling pump 7e (numbers in brackets are outputs). A D/A converter 15 that outputs a signal corresponding to the sign of the part.
Each of these elements except the MPX 15a is connected to each other via a bus (BUS) 15g.

Next, the operation of the apparatus according to the embodiment of the present invention configured as described above will be explained. First, the priming operation is performed as follows. first, third,
When the fourth clamps 8c, 8d are open and the remaining clamps 8a, 8b, 8e, 8f, 8g are closed, the second and third needles 12b, 12c are inserted into the saline bag 2a,
2b are punctured, and the air pump 7d is driven clockwise or in the forward direction, and 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 E 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.

After this, the second clamp 8b, the fifth clamp 8
e, the sixth clamp 8f and the seventh clamp 8g are opened, and the second blood pump 7c is driven. This removes air present in the channel through which the saline flows. Thereafter, when the third detector (physiological saline detector) 6c starts operating and a certain period of time (usually 1 to 2 seconds) has elapsed, the second clamp 8b is closed.

Next, 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 passed since the liquid level detection, 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 physiological saline flows from the saline bag 2a, the air pump 7d is driven clockwise or in the forward direction to create a negative pressure on the outside of the separation membrane of the separator 13 and guide the physiological saline to the outside of the separation membrane. A sixth detector 6 detects that this area is filled with physiological saline.
f is detected, and the air pump 7d is driven in the opposite direction (counterclockwise). 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 11b, 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 total weight of the blood bag 3 gradually increases from the tare weight Gz of the blood bag, as shown in FIG. 2a.

When the total weight of the blood bag 3 reaches the upper limit Gu (time t1), the ACD fluid supply pump 7a is stopped and the first blood pump 7b is driven in the opposite direction to return blood. Incidentally, the second blood pump 7c is continuously driven at the same time as the start of the operation operation, and the second blood pump 7c is continuously driven.
is continuously driven from the time when the separator 13 becomes accustomed to 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 in the opposite direction, and the second clamp 8
b is opened, and after a predetermined period of time, the third clamp 8c is closed. The second blood pump 7c continues to be driven in the same direction (see Figure 2d);
Via the branch D, saline flows into the second blood circuit C. As a result, the blood accumulated in the second blood circuit C is pushed out, and blood components such as blood cells adhering to the inner wall surface of this blood circuit are also washed out at the same time. Such operations are similarly performed in the separator 13, blood bag 3, and blood circuit B connected to the second blood circuit C, and the blood accumulated in these parts is efficiently collected and returned to the donor A. be done.

The end of blood return is detected by the blood detector 11a placed in front of the donor A in the blood circuit B, and when the blood concentration falls below a predetermined value, the first blood pump 7
b and the second blood pump 7c are stopped, and the clamp 8a is closed.

In addition, as a method of detecting the end of blood return, there is a method of ending blood return after a certain period of time has elapsed from the time te when the target serum collection amount is reached, or after sending a predetermined amount of physiological saline from branch D. , closes the second clamp 8b and stops the second blood pump 7c, and then closes the second blood pump 7c.
A possible method is to open the clamp 8f, introduce air into the blood circuit, and detect this with an air bubble detector placed in front of donor A in blood circuit B, thereby detecting the end of blood return. .

As shown in the schematic diagram in Fig. 3, the branch D can be placed at a position where it is connected to the first blood circuit B on the downstream side of the connection points with the first and second blood circuits B and C. good. In this modified embodiment, both the first and second blood pumps 7b and 7c are driven in one direction, and the separator 13 is provided between the first blood pump 7b and the blood bag 3 in the first blood circuit B. It is provided.

With this configuration, blood is collected by closing the clamp 8i and
This is done by opening the clamp 8h and driving the first blood pump 7b. When the weight of the blood bag 3 reaches the upper limit, the clamp 8h is closed (the clamp 8i remains closed), and the second blood pump 7c is driven to return blood. When the weight of the blood bag 3 reaches the lower limit, blood is collected again.

When the target amount of collected serum is reached by repeating such blood collection and blood return, the clamp 8h is closed, the clamp 8i is opened, and the branch D is opened to allow physiological saline to flow into the blood circuit. At this time, the first and second blood pumps 7b,
7c are both driven.

Even with this method, blood can be returned efficiently as in the apparatus according to the embodiment of the present invention shown in FIG.

<Effects of the Invention> In the first aspect of the present invention, after the blood sampling operation is completed, the first blood pump is driven in the opposite direction, the second blood pump is driven, and the separator is removed from the second blood circuit. By flowing physiological saline into the blood bag, all remaining blood in the blood circuit can be collected. Further, in the case of the second aspect of the present invention, the first and second blood pumps are simultaneously driven to flow physiological saline from the first blood circuit to the separator and the blood bag, so that the blood Blood remaining in the circuit can be completely collected.

[Brief explanation of the drawing]

1 and 2 are block diagrams of the apparatus according to the embodiment of the present invention, and FIG. 3 is a time chart for explaining the operation of the apparatus according to the embodiment of the present invention shown in FIG. A...Blood donor, B...First blood circuit, C...
Second blood circuit, D... branch, E... control section, 2
a, 2b... raw food bag, 3... blood bag, 4
...Plasma bag, 7b...First blood pump, 7
c... Second blood pump, 7e... Serum collection pump,
9a-9d...pressure gauge, 11a-11c...blood detector, 12a-12c...needle, 13...separator, 14...weight detector.

Claims (1)

[Scope of Claims] 1. A device for separating plasma from blood collected from a blood donor, comprising: A. A single needle punctured into the donor and used for both blood collection and blood return B. One end is connected to the single needle, and the other end is connected to the single needle. A first blood circuit C that is connected to the blood bag.A second blood circuit D that has one end connected to the first blood circuit and the other end connected to the blood bag.A weight detector E that detects the weight of the blood bag. It is provided in the first blood circuit, and during blood collection operation, the blood bag is driven in the forward direction until the weight of the blood bag reaches a certain upper limit, and is driven in the opposite direction until the weight of the blood bag reaches a certain lower limit from the upper limit. driven,
A first pump F that repeatedly collects blood and returns blood.A second blood pump G that is installed in the second blood circuit, is driven in one direction during plasma collection, and sends the liquid in the circuit to the blood bag side. The blood circuit side and the plasma circuit side are separated by a separation membrane, and the blood circuit side is connected to a second blood circuit,
Separator H that separates plasma in blood from the blood circuit side to the plasma circuit side based on the pressure difference between the blood circuit side and the plasma circuit side.Plasma circuit I connected to the plasma circuit side of the separator.The blood circuit side of the separator and the plasma circuit. Plasma bag K that is installed downstream of the plasma collection pump and stores plasma Saline bag L that is connected to the second blood circuit and stores physiological saline Saline bag Clamp 8b M is provided in the circuit connecting the first blood circuit and the second blood circuit, and is closed during the blood sampling operation and opened during blood collection. It is provided at the connection part and is opened during the sample collection operation.
A clamp 8c is closed during blood collection, and after the blood collection operation is completed, the first blood pump is driven in the opposite direction, and the second blood pump is driven,
A blood sampling device characterized in that physiological saline is allowed to flow through a separator and a blood bag from a second blood circuit to collect blood in the circuit. 2. A device for separating plasma from blood collected from a blood donor, which includes: A. A single needle punctured into the donor for both blood collection and blood return. B. One end is connected to the single needle, and the other end is connected to a blood bag. A first blood circuit C that has one end connected to the first blood circuit and a second blood circuit D that has one end connected to the blood bag.A weight detector E that detects the weight of the blood bag. During blood collection operation, blood is driven in the direction of flowing into the blood bag until the weight of the blood bag reaches a certain upper limit, and when the upper limit is reached, it is stopped until the weight of the blood bag reaches a certain lower limit. A first blood pump F is provided in the second blood circuit, and is driven in a direction to discharge blood from the blood bag until the weight of the blood bag decreases to the lower limit value during blood collection operation, and the first blood pump F a second blood pump G that is stopped until the weight of the blood bag reaches the upper limit; the blood circuit side and the plasma circuit side are separated by a separation membrane; the blood circuit side is connected to the second blood circuit;
Separator H that separates plasma in blood from the blood circuit side to the plasma circuit side based on the pressure difference between the blood circuit side and the plasma circuit side.Plasma circuit I connected to the plasma circuit side of the separator.The blood circuit side of the separator and the plasma circuit. A plasma sampling pump J that forms a pressure gradient between the plasma sampling pump J and the plasma bag K that is installed downstream of the plasma sampling pump and stores plasma.In the first blood circuit, the blood bag side is closer to the connection part with the second blood circuit. A saline bag L for storing physiological saline connected to a saline bag L connected to the saline bag L for storing physiological saline.A clamp 8i that is provided in the circuit connecting the saline bag and the first blood circuit and is closed during blood sampling operation and opened during blood collection. M In the first blood circuit, a clamp 8h is provided between the connection part with the second blood circuit and the connection part with the saline bag, and is opened during plasma collection operation and closed during blood collection. After the blood sampling operation is completed, the first and second blood pumps are simultaneously driven to flow physiological saline from the first blood circuit to the separator and the blood bag to collect the blood in the circuit. A plasma sampling device characterized by: