JPS6249860A - Plasma collector - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

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 (products purified by separating plasma components) are used in winter for various treatments, but most of them are imported. With current blood collection, the maximum amount of blood that can be collected each time is 200 milliliters. According to the current method of collecting only plasma and returning blood cell components to the donor,
Even if twice the amount is taken, there will be no effect on the human body. Therefore, consideration is being given to collecting plasma using such a method and improving the domestic plasma self-sufficiency rate.

The conventional method for separating plasma is to add an anticoagulant (hereinafter referred to as ACD solution) to blood collected from a donor, and then centrifuge the blood in a single centrifugal machine to separate the blood plasma. However, such a centrifugal separation method has disadvantages in that the equipment is expensive and the serum sampling operation is time-consuming.

Recently, a separation membrane using hollow fibers has been developed in which small holes are made in a hollow straw-shaped polymer membrane. Can be configured,
The time required for serum collection work can also be shortened.

However, in the case of such a membrane separation type plasma collection device, if the pressure gradient inside and outside the membrane is increased more than necessary in order to obtain the target serum collection area, hemolysis occurs in which blood cells in the blood are destroyed. This may occur, and the components in the destroyed blood cells may permeate the membrane and be mixed into the plasma as impurities.

Furthermore, the coagulation component contained in plasma, fibrinogen (
When the flow rate of blood flowing to one side of the membrane is small due to wire miscellaneous elements), blood clots occur in the membrane portion of the separator, resulting in clogging of the blood.

<Problems to be Solved by the Invention> A technical problem to be solved by the present invention is to enable efficient plasma collection while preventing hemolysis and blood clotting in the membrane separation type plasma collection device. There is a particular thing.

<Means for Solving the Problems> The configuration of the present invention includes a single needle punctured into a blood donor for both blood collection and blood return, and a temporary storage of blood led through a blood circuit connected to this single needle. a blood bag, means for adding an anticoagulant to blood flowing through the blood circuit, a first blood pump in the blood circuit, and a circulating blood circuit exiting the blood bag and returning to the blood bag; A second blood pump that circulates the blood in the circulating blood circuit, and a second blood pump that is divided into two chambers by a membrane and supplies blood from the circulating blood circuit to one of these chambers, and controls the pressure gradient of the two chambers and the permeation of the membrane. In a membrane separation type plasma collection device comprising a separator that separates plasma in blood by action and a pump that guides the plasma separated by the separator to a plasma bag, the first blood pump is driven and the t11 needle The blood is introduced into the blood bag through the blood donor within a range that does not place a burden on the blood donor's veins, and the plasma pump is driven within a pressure range in which the ultrafiltration pressure (hereinafter referred to as TMP) of the separator does not cause hemolysis. , and the first and second tubes are arranged so that the amount of blood flowing through the circulating blood circuit is sufficiently large compared to that of the plasma collection machine.
and the plasma pump, and when the amount of blood in the blood bag reaches a predetermined value, the first blood pump is reversed and the blood in the blood bag is returned to the donor. That's what I did.

Function> The above technical means works as follows. In other words, blood taken from a single needle punctured by a blood donor is A.
After adding CD fluid, it is introduced into the blood bag. A circulating blood circuit in which the separator is installed is connected to this blood bag, and plasma is collected cyclically while blood is collected from the donor.

The separator is provided with pressure gauges on the blood circuit side and the plasma circuit side, sandwiching the membrane, to measure TMP. The plasma pump has a maximum plasma collection efficiency (
so that it can be used.

Furthermore, the first and second blood pumps and the plasma pump are controlled so that the amount of blood flowing into the blood circuit side of the separator is sufficiently large compared to the amount of plasma collected, and the amount of blood in the separator portion is controlled. Concentration, thereby preventing clogging of the membrane.

<Example> The present invention will be described in detail 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 blood from the donor flows, 1 is an ACD liquid bag storing ACD liquid, 2a and 2b are saline bags storing physiological saline, and 3 3 is a blood bag that stores the collected blood, 3' is a weight detector that detects the weight of the blood bag 3, C is a circulating blood circuit that exits from the blood bag 3 and returns to this blood bag, and 4 is a circuit from which the collected blood is collected. A plasma bag for storing separated plasma, 5 a drainage bag for storing waste fluid, 6a to 6f first to sixth detectors for detecting each fluid (ACD liquid, physiological saline, etc.), 78 to Reference numeral 7e denotes an ACD liquid supply pump, first and second blood pumps, an air pump, and a serum sampling pump that supply fluids (blood, air, etc.), among which the first blood pump 7b and the air pump 7d can be driven in both forward and reverse directions.

88 to 8g are first to seventh clamps that open and close the respective flow paths through which the respective fluids flow; 98 to 9d are first to fourth pressure gauges; 10a to 10c are first to third chambers; 11
a and 11b are a blood detector and a hemolysis detector, respectively; 12a;
- 12c are the 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 in a cylindrical container; Blood flows into the thread.

The part surrounded by the one-dot chain line is the control part, which contains the signals from the first to fourth pressure gauges 9a to 9d (the symbols in parentheses of the inputs correspond to the symbols of the part that generates these inputs). ), and settings (multiplexer (MPX) 14a that takes in Δ numbers a, b, and c in a time-sharing manner, this MPX
A/D converter 14 that A/D converts the analog signal from
b, central processing unit (CPLJ) 14c, random access memory (RA) that temporarily stores read data;
M>146. Read-only memory (ROM) 14e that stores processing routines, arithmetic processing programs, etc.
, D/A converts the digital signal from the CPU 14c, and A
CD liquid supply pump 7a.

First and second blood pumps 7b, 7c, air pump 7d,
It also includes a D/A converter 14f that outputs a drive signal (the number in parentheses corresponds to the code of the part to which the output is given) to the serum sampling pump 7e, and each of these elements except the MPX 14a is connected to a bus ( They are connected to each other via Bus) 14g.

Next, the operation of the device according to the embodiment of the present invention having the grooves as described above will be explained. First, the briming operation is the third,
With the fourth clamps 8c and 8d open, the remaining clamps 8a,
With 8b, 8e, 8f, and 8g open, 2nd and 3rd +
7) The ills 2b and 12c 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 suctioned. Further, when the third pressure gauge 90 indicates a predetermined positive pressure (-Pmm), the air pump 7d is stopped.

After that, the second clamp 8b, the fifth clamp 8e1, the sixth clamp 8f, and the seventh clamp 89 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 1-2
seconds), the second clamp 8b is turned into a lock. Thereafter, the first clamp 8a is placed between them, and the ACD 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 fourth detector 6
d detects the liquid level at the inlet of the separator 13, and after a certain period of time (usually several seconds) has elapsed since this liquid level detection, the sixth clamp 8f is closed and the liquid level in the second chamber (separate inlet chamber) 10b is adjusted. 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 the chamber) 10c is determined.

When the physiological saline has flowed from the saline bag 2a, the air pump 7d is driven to apply positive pressure to the outside of the separation membrane of the separator 13, and to guide the physiological saline to the outside of this separation membrane. The sixth detector 6f detects that this portion is filled with physiological saline, and the air pump 7d is driven in the opposite direction. By driving the air pump 7d in this manner, the portion ys of the separator 13 is
Positive pressure is applied to the outside of the membrane, and physiological saline is introduced 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. The third needle 12G that had been inserted into the saline bag 2b was pulled out and the blood donor △
stung on the arm, etc. Further, the first clamp 8a is opened, and the ACD liquid supply pump 7a, the first blood pump 7b,
And the second blood pump 7C is driven. The physiological saline that had been flowing into the blood circuit due to the briming step 1) is expelled by the blood supplied from the donor A through the third nail 12C, and is discharged into the drain bag 5 in a manner similar to that of the third nail 12C. be discharged. When blood is detected by the blood detector 11a, the fifth
Clamp 8e is closed and fourth clamp 8d is opened. Therefore, blood supplied from the donor is stored in the blood bag 3.

Hereinafter, the serum sampling operation, which is particularly important in the present invention during the operating operation, will be explained according to the flowchart of FIG. 2.

First, step (1) to detect the pressure P1 of the pressure gauge 9a.
), and is compared with a predetermined set value p1 in step (2).

This is because if the pressure in this area becomes too low due to the driving of the first blood pump 7b, it will put a strain on the blood donor A's veins and hurt Shirayuki.

If the pressure P1 is lower than the set value p1, the process proceeds to step (3), where blood is collected by the first blood pump 7b.
Reduce 1Qb. If the pressure P1 exceeds the setting f+I'l p 1, the blood sample ff1Qb is compared with the setting @a in step (4), and if it is below the setting a, the first blood is adjusted to increase Qb. The pump 7b is controlled (step (5)), and if the set value is 8 or more, it is controlled to reduce Qb (step (3)).

In step (6), the flow rate mQa of the ACD liquid is determined by the blood collection f
The ACD liquid supply pump 7a is controlled so that f1Qb becomes 1/1 (where kl is a constant).

Usually about 10).

In step (7), the pressure loss ΔP of the separator 13 is compared with the set value P]. In Hibareta 13,
A hollow fiber 11!1 membrane is used to eliminate pressure drop as blood passes through it. This pressure loss ΔP is expressed as the difference between the pressure P2 of the pressure gauge 9b on the upstream side of the separator 13 and the pressure P3 of the pressure gauge 90 on the downstream side. This value is an indeterminate value that changes depending on the viscosity of the blood and the flow of the blood.

In the comparison in step <7), if the pressure drop is larger than the setting hmp+, the process proceeds to step <8), and control is performed to reduce the blood supply Wt, Qc by the second blood pump 7G. If the pressure loss is less than the set value P1, step (
Proceeding to step 9), the blood supply jQc is compared with the set value, and if it is less than the set value, the second blood pump 7C is controlled to increase Qc (step (10)), and the set value If the value exceeds 1, Qc is controlled not to be reduced (step (8)).

In step (11), the TMP of the separator 13 and the set value Pt are compared. TMP can be expressed by the following formula, TMP-((P2+P3)/2)-P4+ΔP...(
1) (However, P4: Pressure measured by pressure gauge 9d on the plasma circuit side).

If TMP is too high, hemolysis occurs, in which blood cells in the plasma are destroyed. The set value pt is determined at a pressure within a range where such hemolysis does not occur (usually 60 m m
Hg level).

If it is determined in step (11) that the value is equal to or greater than the set value Pt,
Proceeding to step (12), control is performed to reduce the plasma collection ff1Q+) by the plasma collection pump 7e. If TMP is less than or equal to the set value Pt, steps (13) and (14) are selected to check the relationship between plasma collection amounts Qp and Qc and the relationship between Qp and Qb. That is, ff1Qc of blood flowing to the blood circuit side of the separator 13 and the amount of blood collected Qb.
is smaller than the plasma collection IQp, separator 1
Blood clots are more likely to occur in these three areas.

Therefore, in the present invention, first, in step (13), it is determined that Qp<k2・Qc (where k2 is a constant, usually 0.2 to 0°4), and the plasma collection temperature is determined to be higher than Qp 2・Qc. At this time, the serum sampling pump 7e is controlled to reduce Qp (step <12)).

If it is determined that Qp is smaller than 2·Qc, the process proceeds to step (14), where it is determined that Qp<k3·Qb (k3: constant, usually 0.2 to 0.4), and the plasma When the sampling point Qp is greater than 3.Qb, the serum sampling pump 7e is controlled to reduce Qp (step (12))
.

If it is determined that Qp is smaller than 3·Qb, proceed to step (15) and set plasma collection ff1Qp (f[c
are compared. If it is below the set value C, the serum sampling pump 7e is controlled to increase Qp (step (16)), and if it is above the set value C, it is controlled to decrease Qp (step (12)).

While such blood sampling operation is being performed, the blood bag 3
is detected by the weight detector 3', and when the value exceeds a certain upper limit, the ACD liquid supply pump 7a, the first blood pump 7b, and the second blood pump 7C are stopped, and the second blood pump 7C is stopped. 3 Clamp 8C is used as a bolt. Then, the first blood pump 7b is driven in the opposite direction to return blood to the donor. When lff1 of the blood bag 3 detected by the If detector 3' reaches a certain lower limit value, the first blood pump 7b is stopped, and then the ACD liquid supply pump 7a and the first blood pump 7b are moved in the forward direction. The blood sampling and plasma sampling operations are performed again. This kind of behavior is
This process is repeated until the amount of blood collected reaches a predetermined value.

<Effects of the Invention> According to the present invention, in the membrane separation type plasma collection device, efficient plasma collection can be performed while preventing hemolysis and blood coagulation.

[Brief explanation of drawings]

FIG. 1 is a block diagram of the apparatus according to the embodiment of the present invention, and FIG. 2 is a flowchart for explaining the operation of the apparatus according to the embodiment of the present invention shown in FIG. A...Blood donor, B...Blood circuit, C...Circulating blood circuit, D...Control unit, 1...ACD liquid bag, 3.
...Blood bag, 4...Plasma bag, 7a...AC
D liquid supply pump, 7b...first blood pump, 7C
...Second blood pump, 7d...Air pump, 7e
... Serum sampling pump, 9 a ~ 9 d - ... Pressure gauge, 1
2a ~ 12cm (, 13...Hipalator

Claims (1)

[Claims] A single needle punctured into a blood donor for both blood collection and blood return, a blood bag connected to the single needle for temporarily storing blood led through a blood circuit, and an anticoagulant added to the blood flowing through the blood circuit. a first blood pump provided in the blood circuit; a circulating blood circuit exiting from the blood bag and returning to the blood bag; and a second blood pump for circulating blood in the circulating blood circuit. , a separator that is divided into two chambers by a membrane, supplies blood from the circulating blood circuit to one of these chambers, and separates plasma in the blood by the pressure gradient of the two chambers and the permeation effect of the membrane; a plasma pump that guides the separated plasma to a plasma bag, driving the first blood pump to guide the blood from the donor to the blood bag within a range that does not put a burden on the donor's veins; The plasma pump is driven in a pressure range in which the ultrafiltration pressure of the separator does not cause hemolysis, and the first and second The blood pump and the plasma pump are driven, and when the blood volume in the blood bag reaches a predetermined value, the first blood pump is reversed to return the blood in the blood bag to the donor. A plasma sampling device characterized by: