JPS60256466A - Serum sampling apparatus - 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 device for collecting blood cell-free plasma from blood through membrane separation, and in particular, blood collection and blood return are performed using a single puncture needle. The present invention relates to a plasma collection device that can be used to collect plasma.

In recent years, due to advances in hematology and immunology, transfusion of individual blood components such as red blood cells, platelets, and plasma has come to be performed instead of the conventional whole blood transfusion. This component transfusion removes components from whole blood that are unnecessary or harmful to the patient.
It has the great advantage of being able to infuse only the necessary ingredients in large quantities. Plasma transfusion and platelet transfusion are currently commonly used.

Granulocyte transfusion, among others, plasma transfusion is achieving great results in treatments such as plasmapheresis for patients with liver disease, but the present invention particularly provides for the use of plasma for plasma transfusion from healthy plasma donors. This is a device that can safely and efficiently collect samples from

(Prior Art) Conventional plasma collection methods have mainly been performed using centrifuges, but recently plasma collection methods using membranes have been studied. Among the plasma collection methods using such membranes, a method of collecting blood and returning blood using a single puncture needle is known, for example, as described in Artificial Organs Vol. 13, No. 2, 1984, pp. 907-913. is used to supply blood to the membrane module, plasma components that have permeated the membrane are stored in a plasma storage bag, and blood cell components that have not permeated the membrane are stored in the blood storage bag. Then, when returning blood, the blood pump is rotated in the opposite direction, or the blood cell components in the blood storage bag are diluted with a replenisher using a differential pressure based on gravity without using a blood pump, and the blood is returned via the membrane module. It is supposed to be done.

(Problems to be Solved by the Invention) However, in the plasma collection method using the above-mentioned membrane, the diluted blood diluted with a replenisher such as an electrolyte solution is filtered again through the membrane module and returned, so the protein in the collected plasma is There was a problem in that the concentration was diluted by the replenisher that permeated the membrane during blood return.

(Means for Solving the Problems) The present invention solves the above problems by returning blood cell components without passing through a membrane module5). That is, the present invention comprises a blood sampler, a reversible blood pump that transports collected blood or separated blood cell components, a membrane module that separates blood into plasma components and blood cell components through a permeable membrane, and In a plasma collection device equipped with a storage bag for plasma components separated by a membrane module and a storage bag for blood cell components, a bypass circuit is provided in a circuit connecting the membrane modules, and the circuit is controlled in conjunction with the blood pump. This blood sampling device is characterized in that blood is supplied to the membrane module during blood sampling using circuit switching means, and blood cell components in a blood cell storage bag are returned via a bypass circuit when blood is returned.

In the present invention, the blood collection device usually includes a shunt, a syringe needle,
It refers to a catheter, etc., and a reversible blood pump refers to a pump with quantitative performance, such as a roller type pump.

For example, the plasma storage bag and the blood cell storage bag have a capacity of 10
It is preferable to use a commercially available flexible blood bag with a size of 0 to 700 d, but a non-flexible container or the like may also be used.

,,,a. 1~Yui%)z-tvoMtif;E,
Imuh '□ (A three-way switching valve may be provided at the branch portion of the bypass circuit, or a shutoff valve may be provided in each of the above circuits.

A pinch valve is usually used to prevent blood damage.

As the membrane module, for example, one having a structure like a water droplet shown in FIG. 3 is used. FIG. 3 is a sectional view showing one example of a membrane module, including a blood inlet 30, a blood cell outlet 31, a plasma outlet 32, and so on. It has a large number of hollow fibers 33 filled inside. The ends of the hollow fibers 33 form adhesive solidified parts with adhesive 34, and near the solidified parts, nozzles 35 and 36 having blood cells 30 and blood cell outlets 31 are tightened with caps 38 that screw into the threaded parts of the main body 37. It is being This is a structure in which blood flows through the hollow part of the hollow fiber, and plasma moves outward from the hollow part of the hollow fiber. vice versa,
A membrane module having a structure in which blood flows outside the hollow fibers and plasma moves into the hollow portions can also be used.

As the permeable membrane accommodated in the membrane module, any membrane that allows plasma (proteins, albumin, globulin, etc.) to pass through but not blood cells can be used. Therefore, the pore diameter is 1μ
The thickness must be 0.01μ or more), and both flat membranes and hollow fibers can be used.

Such membranes include polyvinyl alcohol (pV
Homogeneous microporous membranes or asymmetric membranes made of A) type, ethylene vinyl alcohol (EVA) type copolymers, cellulose conductors such as cellulose acetate, polyolefins, polyacrylonitrile, polyamides, polyesters, polysulfones, etc. are used. Among these, it is desirable to use membranes of EVA type, EVA type, cellulose permeable material, polysulfone, etc., which have excellent biocompatibility.

(Example) Next, one embodiment of the device of the present invention will be described with reference to the drawings.

In Figure 1, there is a blood collection needle (1) that punctures the vein of a plasma donor and serves as a flow path for blood collection and blood return, and a membrane module (
4) is connected via a reversible blood pump (2,), and the blood cell outlet of the membrane module is further connected to a flexible blood cell storage bag (5). Further, the lower end of the blood cell storage bag (5) is connected to a bypass circuit that bypasses the membrane module. As the circuit switching means, a pinch pulp (8) is attached near the blood inlet of the membrane module in the circuit connecting the membrane modules, and a pinch valve (8) is attached to the bypass circuit. Membrane module (4
The plasma outlet of the plasma pump (6) is connected to a flexible plasma storage bag (γ) with a capacity of e.g. Alternatively, differential pressure based on gravity may be used.

The anticoagulant bag (g) stores blood anticoagulants such as heparin and ACD, and the anticoagulant infusion pump (9)
Only when blood is collected, the blood is injected into a location between the blood collection needle (1) and the blood pump (2), as close to the blood collection needle as possible.

In FIG. 1, a blood pump (2), a plasma pump (6),
The anticoagulant injection pumps (9) all use quantitative roller type pumps, but the drive shafts of the motors (b), α→, and (b), which are the drive sources, are AC type. It is mechanically connected to the tacho generator (2), (b), and (g). ,stomach. fi:z9x*Ly-1 (3g
,. ,.

The electrical signals (g), (h), (U) are sent to the control unit 20 to monitor the amount of blood collected, the amount of plasma collected, and the amount of anticoagulant injected.

(Function) Regarding the operation of the plasma collection device according to the present invention, FIGS.
This will be explained using figures.

[Blood removal process]

As shown in Fig. 1, when a forward rotation command signal (d) and a rotation setting signal (a) are sent from the control unit to the driver o of the blood pump (2), the control unit operates in conjunction with the forward rotation command signal. Then, an open signal (e) to the pinch pulp (8) and a close signal (f) to the pinch pulp (8) are transmitted from the control unit. Then, the blood pump (2) rotates normally, and blood is taken out of the body from the blood collection needle (1) punctured into the vein of the plasma donor at a flow rate of approximately 40 to 60 wL/min. ) will be sent to.

Further, a rotation setting signal (b) corresponding to about 20 to 40 degrees of the rotation setting signal (a) of the blood pump is sent to the driver α6) of the plasma pump (2), and the plasma pump (6)
It rotates at a flow rate of −20 d/min to deliver the plasma separated by the membrane module (4) to the plasma storage bag (γ). film
Blood cell components coming out of the blood cell outlet of the 1'1 module (4) are stored in a blood cell storage bag (5). On the other hand, a rotation setting signal (C) is sent to the driver (17) of the anticoagulant injection pump (9), and the injection pump rotates to inject the anticoagulant into the collected blood.

If this state continues, more and more blood will be taken out of the body from the plasma donor, and the plasma will also be transferred to the plasma storage bag (γ).
It is stored in.

However, the amount of blood that can be safely removed from the body is usually 200.
rll, the maximum is 400 wl. Therefore, it is necessary to monitor the amount of blood collected, but in the present invention, the signal (g) sent from the AC tacho generator (2) of the blood pump (2) is converted into the amount of blood collected by the control unit (a) and integrated. At the same time, it is a trap to be constantly monitored. The amount of blood collected is the set value for extracorporeal removal per cycle (usually 200 m
When the speed exceeds 1-400 (set in the range of 400 penalties), the control unit sends a 0x number as the rotation setting signal a to the blood pump driver (Kon), and the blood pump (2) stops. The rotation setting signal (b) is sent to the driver 06 of the plasma pump (6) and the driver of the anticoagulant infusion pump (9) at the same time as the signal (a), and (0 (i) is sent as C1. and stop the plasma pump (6) and anticoagulant infusion pump (9).

The above-mentioned plasma collection amount and anticoagulant injection amount are determined by signals (h) sent from the AC tachogenerator house 9, (g) of the plasma pump (6) and anticoagulant injection pump (9), respectively.
The control unit converts (i) into the amount of plasma collected and the amount of anticoagulant injected, integrates it, and monitors it at the same time.

[Blood return process]

As shown in Figure 2, the blood pump (2) driver QB
) is sent a reverse rotation command (d') from the control unit (b), and a rotation setting signal (approximately 1.5 to 2.0 times larger than the forward rotation) is sent to the control unit (b).
a') and blood pump (2) at 75 #/min ~ 10
Rotate in reverse at a flow rate of 0WLe/min. At the same time, the control unit sends a pinch valve (s) K close signal (e')
, sends an open signal (f') to the pinch valve (8), and transfers the blood cell components accumulated in the blood cell storage bag (5) to the bypass circuit (
21), the blood is returned from the blood collection needle (1) to the vein of the plasma donor. In the blood return process, 0 signals are sent to the drivers (14)% (b) of the plasma pump (6) and anticoagulant infusion pump (9) as rotation setting signals (b) and % (C), respectively. Pump is stopped.

The amount of blood collected and the amount of plasma collected in the blood collection process described above are stored in the control unit ■, so the amount of blood and plasma collected are stored in the control unit (company).
are compared. If the blood return volume when the pump is rotated in reverse, which is calculated from the AC tacho generator (b), is equal or larger, an O signal is sent to the rotation setting signal (a') to stop the blood pump (2). .

In addition to the above method of terminating the blood return process by comparing the amount of blood collected and the amount of plasma collected, there are also methods of setting the blood return time with a timer, and installing an air detector in the bypass circuit and detecting air to stop the blood return process. It is also possible to adopt a method such as terminating the process. Add the desired amount (usually 300 to 600) to the plasma storage bag (7).
The cycle of the blood collection step and blood return step is repeated until the plasma of WLe) is collected.

For example, plasma was collected from cow blood with a hematocrit value of 38% using the device of the present invention under the following conditions.
, 3m" (Kuraray M) Blood collection amount 50 d/min Plasma collection amount 20-25 d/min Blood return amount Blood return amount/min Blood collection time 8 minutes Blood return time 3 minutes Blood collection process 10 blood return process 1 under the above conditions By repeating the cycle three times, good plasma with a total protein recovery rate of 0.9 or more could be collected from 480.

(Effects of the Invention) As described above, the device of the present invention collects only the plasma in the blood from the plasma donor, and does not collect whole blood unlike the current blood donation system, which places a burden on the plasma donor. is less and safer.

By appropriately selecting the pore size of the separation membrane housed in the membrane module, it is possible to efficiently collect albumin-rich, high-quality plasma. Only one collection needle is inserted into the plasma donor. This causes very little pain to plasma donors.

The blood cell components that come out from the membrane module outlet are redistributed to the membrane percentage.
95- #□□-j-, 6-keku, 24i2.71□
Because it passes through one circuit, high-quality plasma with high protein concentration can be collected. Furthermore, since clogging of the separation membrane can be avoided, plasma components can be efficiently collected, making it an extremely useful device in practice.

[Brief explanation of drawings]

Figures 1 and 2 are system diagrams of the plasma collection device of the present invention, and Figure 3 is a cross-sectional view of the membrane module.
Membrane module 5: Blood cell storage bag 6; Plasma pump 7
：Plasma storage）Clug 8：Pinch bulp 9：Anticoagulant injection tube 10：Anticoagulant storage bag Patent applicant RiRa Co., Ltd. Representative patent attorney Ken Honda Figure 2 Figure 3 Procedural amendment ( (Spontaneous) August 23, 1985 Japanese Patent Application No. 113496/1985 2 Name of the Invention Plasma Collection Device 3 Relationship to the case of the person making the amendment Patent applicant: Rira Shi Co., Ltd., 1621-108 Sakago, Kurashiki City 2-45-1 Aoeyama, Sakazu, Kurashiki City Kuraray Co., Ltd. Patent Department The "Claims" column and "Details of the Invention 11" of the specification
11i Explanation d, Column 6, Contents of the amendment (1) "Claims" column Attachment sheet (2) "Detailed description of the invention" column ■Letter of specification, page 3, lines 19 to 4 1 on the 10th line of the page, that is, it is a plasma collection device. In other words, the present invention comprises a blood sampler, a reversible blood pump that transports collected blood or separated blood cell components, and a membrane module that separates blood into plasma components and blood cell components through a permeable membrane. In a plasma collection device equipped with a storage bag for blood cell components, a storage bag for plasma components separated by the membrane module, and a storage bag for blood cell components, a bypass circuit is provided in the circuit connecting the acid membrane module μ, and the circuit A circuit switching means is provided for interlocking control with the blood pump, and by switching the switching means, blood is supplied to the membrane module through the circuit when blood is collected, and blood cell components in the blood cell storage bag are supplied to the membrane module when blood is returned. amended to 7j' (a plasma collection device characterized in that it is configured to return blood through a bypass circuit).'' The above claims refer to a blood collection device (1) and collected blood or separated blood. a reversible blood pump (2) that transports blood cell components, a membrane module (4) that separates blood into plasma components and blood cell components via a permeable membrane, and a plasma component separated by the membrane module. A plasma collection device comprising a storage bag (7) for blood cell components and a storage bag (5) for blood cell components, characterized in that a bypass circuit Q1) is configured in the circuit connecting the membrane module (4). Device.

Claims (1)

[Claims] A blood sampler (1), a reversible blood pump (2) that transports collected blood or separated blood cell components, and a membrane module (2) that separates blood into plasma components and blood cell components via a permeable membrane. 4), a plasma collection device equipped with a storage bag (7) for plasma components separated by the membrane module and a storage bag (5) for blood cell components, and a bypass is connected to the circuit connecting the membrane module (4). In addition to installing a circuit room 1),
The circuit includes circuit switching means (
83(8) A disintegrated plasma collection device characterized in that when blood is collected, blood is supplied to the membrane module, and when blood is returned, blood cell components in a blood cell storage bag are returned via a bypass circuit.