JPH0458990B2 - - Google Patents

Description

[Detailed Description of the Invention] <Industrial Application Field> The present invention is applicable to a priming operation that uses physiological saline to clean a blood circuit, and an operator who collects plasma contained in blood collected from a blood donor. The present invention relates to a membrane separation type plasma collection device configured to automatically perform operation and a collection operation for collecting blood flowing in a blood circuit.

<Prior Art> Generally, blood collected from a donor's body contains blood cells and plasma. This plasma consists of a supernatant liquid obtained by adding an anticoagulant (hereinafter referred to as "ACD liquid") to collected blood and separating it using a centrifuge or the like. For this reason, a predetermined plasma collection device has come to be used to collect the plasma from the donor's body.

However, with conventional plasma collection devices, it is difficult for nurses to determine the level of each chamber in the priming operation, check drainage to replace saline with blood, and check the amount of remaining blood in the blood collection operation. This was done by manual operation. For this reason, the efficiency of collecting plasma from the donor's body is extremely low, and the time required to restrain the donor is extremely long.

<Problems to be Solved by the Invention> The present invention has been made in view of the drawbacks of the conventional examples, and its purpose is to prevent plasma from being diluted by the physiological saline used in the priming operation. It is an object of the present invention to provide a membrane separation type plasma collection device that can prevent the above problems, improve plasma collection efficiency, and shorten the detention time of blood donors.

<Means for solving the problems> The features of the present invention that solve the above problems are as follows.
In the membrane separation type plasma collection device, first and second saline bags, an ACD liquid bag, a blood bag into which blood collected from a donor is led and stored, and a blood bag into which plasma separated from the blood is led are introduced. a separator whose interior is divided into an inner chamber and an outer chamber by a membrane; a first chamber for introducing a blood coagulation inhibitor from the ACD liquid bag;
A first pump provided in a flow path, a second clamp that opens and closes a second flow path that leads physiological saline from the first saline bag, and a second clamp that opens and closes a second flow path that leads physiological saline from the second saline bag or from the blood donor. a third flow path for guiding blood; a fourth flow path to which the third flow path and the first flow path are connected; and a first flow path for opening and closing the fourth flow path;
a clamp, a second pump for feeding fluid flowing through the fourth channel, a first chamber disposed between the second pump and the first clamp, an inner chamber of the separator and the blood bag; a fifth flow path connected to the blood circulation circuit through a second chamber and forming a part of the blood circulation circuit; a third pump disposed in the fifth flow path for circulating the fluid flowing in the blood circulation circuit; a third clamp provided between the third pump and the blood bag to open and close the fifth flow path; a sixth clamp to open and close the flow path leading from the second chamber to the atmosphere; a sixth flow path connecting the blood bag via a third chamber and forming the remaining part of the blood circulation circuit;
a fourth clamp that is provided between the chamber and the blood bag and opens and closes the sixth flow path; a seventh clamp that opens and closes the flow path leading from the third chamber to the atmosphere; and the sixth flow path and the drain liquid. a fifth clamp that opens and closes a seventh flow path that connects the separator; and a fourth clamp that is installed in an eighth flow path that connects the outer chamber of the separator to the atmosphere and makes the pressure inside the outer chamber negative or positive.
a pump, and a fifth pump disposed in a ninth flow path connecting the outer chamber of the separator and the plasma bag to guide plasma that has reached the outer chamber of the separator to the plasma bag, After washing with the physiological saline, the blood collected from the donor is stored in the blood bag, guided to the blood circulation circuit, collected by the separator, and then flows through the blood circulation circuit. This problem is solved by collecting blood by opening and closing the first to seventh clamps and turning on and off the first to fifth pumps.

<Example> Hereinafter, the present invention will be described in detail using figures. FIG. 1 is an explanatory diagram of the configuration of an embodiment of the present invention,
In the figure, 1 is an ACD liquid bag that stores ACD liquid, 2a and 2b are first and second saline bags that store physiological saline and have internal volumes of, for example, 500 ml and 1000 ml, respectively, and 3 is a collection bag. 3' is a weight detector that detects the weight of the blood bag 3; 4 is a plasma bag that stores plasma separated from the collected blood; 5 is a drain that stores waste fluid; Back, 6a to 6f are each fluid (ACD liquid,
1st to detect physiological saline, blood, etc.)
~The sixth detector, 7a to 7e, is the first ~ which can send fluid (blood, air, etc.) in both forward and reverse directions.
A fifth pump, 8a to 8g are first to seventh clamps that open and close the flow paths through which the respective fluids flow; 9a to 9d are first to fourth pressure gauges; 10a to 8g;
10c is the first to third chamber, 11a, 11
b are a blood detector and a hemolysis detector, respectively, 12a
- 12c are the first to third needles; 13 is the inner chamber 1 formed by a membrane 13a such as a coarse dialysis membrane;
The separator is, for example, a double-tube structure that is divided into an outer chamber 13b and an outer chamber 13b. Further, FIG. 2 is a time chart for explaining the operation of the embodiment of the present invention.

The operations of the embodiment of the present invention having such a configuration are roughly divided into three types: priming operation, operating operation, and recovery operation. Each of these operations will be explained in detail below. First, a priming operation for cleaning the blood circuit using physiological saline will be described.

In FIG. 1, the third and fourth clamps 8c,
8d is open and the remaining clamps (i.e., the first clamp 8a, second clamp 8b, fifth clamp 8e, sixth clamp 8f, and seventh clamp 8g) are closed, the needle 1a in FIG. The liquid bag 1 is punctured, and the second and third needles 12b, 12
c is punctured into saline bags 2a and 2b, respectively,
The fourth pump (air pump) 7d is driven in the forward direction (that is, it is in the state shown in FIG. 2). Therefore, not only the inside of the outer chamber 13c of the separator 13 but also the flow path from the blood bag 3 to the inner chamber 13b of the separator 13 via the third chamber 10c (that is, inside the blood bag 3 and from the bag 3) The air present in the flow path leading to the fourth pump 7d is sucked. As a result of doing this, the third pressure gauge 9c
When the pressure reaches a predetermined negative pressure (-P ₁ mmHg), the fourth pump 7d is stopped. Then the third
While the clamp 8c and the fourth clamp 8d are closed, the second clamp 8b, the fifth clamp 8e,
The sixth clamp 8f and the seventh clamp 8g are opened, and the third pump (circulation pump) 7c is driven (that is, the state shown in FIG. 2 is reached). The third pump 7c is driven to remove air present in the second flow path through which the saline flows, and for a certain period of time after the third detector (saline detector) 6c starts operating. After T ₁ (usually 1 to 2 minutes) has passed, the second clamp 8b is closed.

At the same time, the first clamp 8a and the third clamp 8
c is opened and the first pump (ACD pump) 7a
And the second pump (blood pump) 7b is driven (that is, the state shown in FIG. 2 is achieved). Note that the flow rate ratio between the second pump 7b and the third pump 7c is 10:9 at this time, so that a portion of the saline solution is stored in the saline bag 3. Also, the first
The pump 7a is driven through the first channel through which the ACD liquid flows.
This is done to remove the air present in the flow path by flowing the ACD liquid, and the first detector (ACD liquid detector) 6a starts operating for a certain period of time T ₂ (usually 1~ 2 minutes), the first pump 7a is stopped (that is, the state shown in FIG. 2 is reached). Thereafter, the fourth detector 6d detects the liquid level at the inlet of the separator 13, and after a certain period of time _T3 (usually several seconds) has passed since the liquid level detection, the sixth clamp 8f
is closed (that is, the state shown in Figure 2 is reached),
Second chamber (separator inlet chamber) 1
The liquid level of 0b is determined. Thereafter, the physiological saline in the saline bag 2b guided by the second pump 7b and the third pump 7c is guided to the sixth flow path through the inner chamber 13b of the separator 13.

Similarly, the fifth detector 6e detects the liquid level at the outlet of the separator 13, and after a certain period of time _T4 (usually several seconds) has passed since the liquid level detection, the seventh clamp 8g
is closed (that is, the state shown in Figure 2 is reached),
Third chamber (separator exit chamber) 1
The liquid level of 0c is determined. The physiological saline that has passed through the third chamber 10c flows into the drainage bag 5 through the seventh flow path. Further, when, for example, about 200 ml of physiological saline has flowed from the second saline bag 2b, the fourth pump 7d is driven in the forward direction (that is, the state shown in FIG. 2 is reached), and the separator 1
The inside of the outer chamber 13c of No. 3 is made negative pressure, and physiological saline is introduced into the outer chamber 13c through the membrane 13a of the separator 13. When the sixth detector 6f detects that the outer chamber 13c is filled with physiological saline, the fourth
The pump 7d is driven in the opposite direction (that is, the state shown in FIG. 2 is achieved). Such a fourth pump 7d
As a result, the outer chamber 13c of the separator 13 becomes positive pressure, and the physiological saline in the outer chamber 13 flows into the separator 1.
3 into the inner chamber 13b through the membrane 13a. Further, when the pressure inside the outer chamber 13c of the separator 13 (that is, the secondary pressure of the separator displayed on the fourth pressure gauge 9d) reaches a constant pressure P ₂ (for example, 200 mmHg), the fourth pump 7d is turned back on. The blood circuit is repeatedly washed with physiological saline by driving in the direction (that is, the state shown in FIG. 2 is reached). After that, the outer chamber 13c of the separator 13 is again
When the internal pressure (that is, the separator secondary pressure displayed as the fourth pressure 9d) reaches a constant pressure P ₂ (for example, 200 mmHg), the fourth pump 7d stops. (That is, the state shown in FIG. 2 is reached).

After that, when about 800ml of physiological saline has flowed into this blood circuit from the saline bag 2b,
The second pump 7b and the third pump 7c are stopped, and the first clamp 8a is closed (i.e.,
(It will be in the state shown in Figure 2). Further, the fourth pump 7d is driven in the forward direction, and the secondary pressure (that is, the pressure inside the outer chamber 13c) is reduced to a constant pressure P ₂ (for example,
200 mmHg) to a predetermined pressure P ₃ (for example, atmospheric pressure) (that is, the state shown in Fig. 2 is reached). When the secondary pressure decreases in this way, the fourth pump 7
d is stopped, and at the same time, the fourth clamp 8d is opened for a certain period of time _T4 (for example, several minutes), and the saline stored in the blood bag 3 is drained into the drain bag 5.
(that is, it will be in the state shown in Figure 2).

In this way, the third and fourth clamps 8c, 8d
A series of operations from the operation in which the fourth pump 7d is driven while the clamp is open to the operation in which the fourth clamp 8d is opened for a certain period of time _T4 (i.e., ~ in Fig. 2).
2), the priming operation is completed, and the fourth clamp 8c and the fifth clamp 8e are closed (that is, the state shown in FIG. 2 is reached).

Next, an operating operation for collecting plasma contained in blood collected from a blood donor will be explained. In FIG. 1, first, the third needle 12c that has been inserted into the saline bag 2b is pulled out and inserted into the donor's arm (not shown). Further, the first clamp 8a and the fifth clamp 8e are opened, and the first clamp 8a and the fifth clamp 8e are opened.
Pump 7a, second pump 7b, and third pump 7
c is driven (that is, it is in the state shown in FIG. 2). Therefore, the physiological saline that has been flowing into the blood circuit due to the above-mentioned priming operation is expelled by the blood supplied from the blood donor through the third needle 12c, and finally drains into the drain bag 5. is discharged. In this way, when blood is detected by the blood detector 11a, the fifth clamp 8e is closed and the fourth clamp 8d is opened (that is, the state shown in FIG. 2 is reached). Therefore, blood supplied from a donor is stored in the blood bag 3. The weight of the blood bag 3 is detected by a weight detector 3', and when the value exceeds a certain upper limit, the first pump 7a, the second pump 7b, and the third pump 7c are stopped, and the third pump is stopped. Clamp 8c is closed (ie, in the state shown in FIG. 2).

Thereafter, the second pump 7b is driven in the opposite direction (that is, the state shown in FIG. 2 is reached), and when the weight of the blood bag 3 detected by the weight detector 3' reaches a certain lower limit value, 2 pump 7b is stopped (that is, the state shown in FIG. 2 is reached). after that,
The third clamp 8c is opened, the first pump 7a and the second pump 7b are driven in the forward direction, and as the weight of the blood bag 3 increases, the rotational speed of the third pump 7c increases (i.e., (It will be in the state shown in Figure 2).

In this way, a certain amount of blood is transferred to the separator 13.
The membrane 13 is conditioned by this blood. Thereafter, the fifth pump (plasma pump) 7e is driven (that is, the state shown in FIG. 2 is achieved).
The rotation speed of the pump 7e is gradually increased, and plasma is gradually stored in the plasma bag 4 according to the rotation speed. In this way, when the weight of the blood bag 3 detected by the weight detector 3' reaches a certain upper limit, the first and second pumps 7a and 7b are stopped. (That is, the state shown in FIG. 2 is reached). A series of operations in which plasma is collected by driving the fifth pump 7e while the second pump 7b is driven in the forward direction (i.e., the operation to bring the state to ~ in Fig. 2) is called a blood collection cycle. There is.

Thereafter, the second pump 7b is driven in the opposite direction (that is, it is in the state shown in FIG. 2). after that,
When the weight of the blood bag 3 reaches a certain lower limit, the pump 7b is stopped (that is, the state shown in FIG. 2 is reached). A series of operations in which plasma is collected by driving the fifth pump 7e while the second pump 7b is driven in the opposite direction (i.e., the operation to bring the state to the state shown in FIG. 2) is called a blood return cycle. I'm here.

By repeating such blood collection cycles and blood return cycles, when the amount of collected plasma reaches a certain target value, the above-described blood return cycle is performed again. After this blood return cycle is completed, the first to fifth pumps 7a to 7e are stopped (that is, the state shown in FIG. 2 is reached). From the operation in which the third needle 12c is inserted into the blood donor, the first to fifth pumps 7a to
A series of operations up to the stop of 7e (i.e., the second
The operation operation is completed by the operation that brings the state to the state shown in the figure.

Finally, a collection operation for collecting blood flowing in the blood circuit will be described. First, the fourth pump 7d in FIG. 1 is driven in the opposite direction (that is, the state shown in FIG.
The third pressure gauge 9e indicates that the pressure inside the outer chamber 13c has reached the predetermined pressure _P4 mmHg.
When detected, the fourth pump 7d is stopped (that is, the state shown in FIG. 2 is reached). When the pressure inside the outer chamber 13c of the separator 13 is maintained at a positive pressure in this way, the plasma present in the outer chamber 13c is guided into the inner chamber 13b via the membrane 13a.

Thereafter, the second clamp 8b is opened (i.e.
After a predetermined time T ₅ (usually several seconds) has elapsed, the third clamp 8c is closed and the second and third pumps 7b and 7c are driven in the reverse and forward directions, respectively. (that is, the state shown in FIG. 2 is reached), and physiological saline from the second saline bag 2b flows into the blood circuit by the third pump 7c. When about 200 ml of this saline has flowed, the second and third pumps 7b, 7c are stopped, and the first clamp 8a is also closed (i.e., the second
(It will be in the state shown in the figure).

The recovery operation is completed by a series of operations from driving the fourth pump 7d in the opposite direction to closing the first clamp 8a (i.e., the operation to bring the state to the state of ~ in FIG. 2). .

After this collection operation is completed, the blood donor and the saline bag 2
The needles 12b and 12c are removed from the needle a, and the operation of the embodiment of the present invention is completed.

Note that the collection operation described above is not limited to the above-described embodiment, and can be modified in various ways, for example, the following content may be used. That is, the second and third
By driving the pumps 7b and 7c, when about 200 ml of physiological saline has flowed into the blood circuit, the second clamp 8b is closed and the third pump 7c is stopped. Thereafter, the sixth clamp 8f is opened and air is introduced into the blood circuit. While expelling the saline with this air, when the second detector (bubble detector) 6b is activated, the first clamp 8a is closed and the second pump 7b is stopped. Through this operation, most of the saline in the blood circuit is returned to the blood donor, completing the collection operation.

<Effects of the Invention> According to the present invention as described in detail above, it is possible to prevent plasma from being diluted by the saline used in the priming operation, improve plasma collection efficiency, and improve blood donor blood flow. A membrane separation type blood sampling device that can shorten detention time will be realized.

That is, in the operating operation, first, blood collected from a blood donor is introduced into the separator, and while the membrane inside the separator is being conditioned by the blood,
The physiological saline in the blood circuit used in the priming operation is replaced with blood and expelled, and after a blood detector detects that the saline has been expelled, the blood is stored in a blood bag. Therefore, the inside of the blood bag is not diluted with physiological saline, and as a result, it becomes possible to prevent the obtained plasma from being diluted with physiological saline. Further, when the weight of the blood bag exceeds a certain upper limit or becomes smaller than a certain lower limit, the blood pump is reversed, and blood collection and blood return are continuously repeated. Therefore, the blood in the blood bag is always sent to the separator by the blood circulation pump both when blood is collected and when blood is returned. Therefore, plasma can be continuously collected (plasma collected) regardless of whether blood is being collected or returned, improving plasma collection efficiency and reducing donor detention time. can. Furthermore, since the above-mentioned priming is automated by the opening/closing operation of the first to first clamps and the on/off operation of the first to fifth pumps, the labor of operators such as nurses is saved, and the nurses can take care of the next blood donor. Secondary effects have also been obtained, such as the ability to

[Brief explanation of the drawing]

FIG. 1 is a configuration explanatory diagram of an embodiment of the present invention, and FIG. 2 is a time chart for explaining the operation of the embodiment of the present invention. 1...ACD liquid bag, 2a, 2b...saline food bag,
3...Blood bag, 3...Weight detector, 4...Plasma bag 5...Drainage bag, 6a-6f...Detector, 7a-
7d...Pump, 8a-8g...Clamp, 9a-9
e...Pressure gauge, 10a-10c...Chamber, 11
a, 11b...blood detector and hemolysis detector, 12a
~12c...needle, 13...separator.

Claims (1)

[Claims] 1 First and second saline bags, an ACD liquid bag, a blood bag into which blood collected from a donor is led and stored, and a plasma bag into which plasma separated from the blood is led and stored. a drain bag, a separator whose interior is divided into an inner chamber and an outer chamber by a membrane, and a first pump provided in a first flow path for introducing an anticoagulant from the ACD liquid bag; a second clamp that opens and closes a second channel for guiding physiological saline from the first saline bag;
a third channel for guiding physiological saline from the saline bag or blood from the donor; a fourth channel to which the third channel and the first channel are connected at one end; and the fourth channel. a first clamp that opens and closes the fourth flow path; a second pump that sends fluid flowing through the fourth flow path;
a first clamp disposed between the pump and the first clamp;
a fifth flow path that connects the inner chamber of the separator and the blood bag via a second chamber and constitutes a part of the blood circulation circuit; a third pump that circulates fluid flowing through the blood bag; and a third pump that is provided between the third pump and the blood bag and that opens and closes the fifth flow path.
a sixth clamp that opens and closes a flow path leading from the second chamber to the atmosphere; and a sixth clamp that connects the inner chamber of the separator and the blood bag via a third chamber and constitutes the remainder of the blood circulation circuit. a fourth channel provided between the third chamber and the blood bag for opening and closing the sixth channel;
a seventh clamp that opens and closes a flow path leading from the third chamber to the atmosphere; and a fifth clamp that opens and closes a seventh flow path that connects the sixth flow path and the drain bag.
a fourth pump that is provided in an eighth flow path that connects the outer chamber of the separator to the atmosphere and makes the pressure in the outer chamber negative or positive; and a fourth pump that connects the outer chamber of the separator and the plasma bag. a fifth pump disposed in a flow path 9 to guide the plasma that has reached the outer chamber of the separator to the plasma bag, and after washing the blood circulation circuit with the physiological saline, The first to seventh steps include storing blood collected from the blood in the blood bag, guiding it to the blood circulation circuit, collecting the blood with the separator, and then collecting the blood flowing in the blood circulation circuit.
A membrane separation type serum sampling device characterized in that the operation is performed by opening/closing operations of a clamp and on/off operations of the first to fifth pumps.