JPS59141951A - Serum separation appartus - 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] ■, Background technology field of invention The present invention relates to a plasma separation device.

Specifically, the present invention relates to a plasma separation device for efficiently collecting separated plasma using a model plasma separation device after filtration.

BACKGROUND OF THE INVENTION Currently, model plasma separators are used to replace blood plasma in the human body with fresh plasma or to separate abnormal substances from the blood plasma. Conventionally, a filtrate circuit as shown in FIG. 1, for example, has been used as such a membrane type plasma 1 m device. That is, blood is removed by the pump 2 through the inlet tube 1 of the blood circuit connected to the patient's artery or vein (not shown), and is once stored in the inlet side air trap 4 having the blood inlet pressure ff+3. , is introduced into the hollow fiber plasma separator 6 through the blood inlet 5. The blood concentrated in the plasma separator 6 flows out from the blood outflow lower, is temporarily stored in the outlet side air trap 9 equipped with the blood outlet pressure gauge 8, and is then led to the outlet pipe 70, and is led to the patient's vein (not shown). will be returned to. On the other hand, the plasma filtered by the model plasma separator 6 flows out from the plasma outflow port 11a or, if the amount is large, from the plasma outflow ports 11a and 11b, and flows into a plasma side air trap equipped with a plasma pressure gauge 12. After being stored in 13th,
The plasma is discharged from the plasma discharge tube 14 by the action of the pump 15,
Normal plasma is introduced through the plasma inlet tube 16, or a secondary plasma separator (
Not shown. ), normal plasma separated by
These plasmas pass through the outlet air trap 9 and are returned to the patient's veins together with the concentrated blood.

After the necessary amount of plasma has been filtered and separated, the pump 15
At the same time, the supply of normal plasma is also stopped, and the pump 2 is also stopped. Next, after removing the inlet tube 1 from the artery, it is connected to a physiological saline supply source, and the pump 2 is slowly rotated to supply physiological saline to the plasma separator 6 while washing the inside of the separator 6. The blood is collected and returned to the human body. Furthermore, the saline supply source is removed and the outlet tube 10 is
After clamping at an appropriate location, the pump 2 is slowly rotated to supply air to the separator 6 for near-rinsing. In this case, an air discharge syringe (not shown) is attached to the outlet side air trap 9. ) is attached, the collected blood is stored in the air trap 9, and the air is discharged from the syringe. Next, after canceling the near rinse, activate pump 2 and get raw I! I! The blood in the outlet side air trap 9 is returned to the patient by circulating saline.

On the other hand, the plasma in the plasma discharge pipe 14 is discharged and collected by releasing the plasma side air trap 13, but the plasma in the pipe reaching the filtrate side of the membrane in the model plasma separator 6 and the air trap 13 is There was a drawback that plasma could not be collected, resulting in large losses of plasma.

(1) Purpose of the Invention Therefore, the purpose of the present invention is to provide a new plasma separation device. An object of the present invention is to provide a plasma separation device for efficiently recovering separated plasma using a model plasma separator after filtration.

The present invention provides a plasma separator comprising a model plasma separator equipped with a blood inlet, a concentrated blood outlet, and a plasma outlet, each connected with a blood inlet circuit, a blood outlet circuit, and a plasma outlet circuit. This plasma separator is characterized in that a liquid storage tank having a conduit connected to the lower part and filled with a washing liquid inside is connected to the plasma discharge side of the model plasma separator via the conduit.

Further, the present invention is a plasma separation device in which the liquid storage tank is configured to be able to communicate with the atmosphere. Furthermore, the present invention is a plasma separation device in which the washing liquid is a briming liquid introduced from a blood introduction circuit. Further, the present invention is a plasma separator in which the model plasma separator is a flat membrane plasma separator. Furthermore, the present invention provides a plasma discharge port provided on at least two sides, and a conduit connected to the reservoir communicating with the plasma discharge port located above one of the plasma discharge ports. This is a plasma separation device.

(1) Detailed Description of the Invention Next, one embodiment of the present invention will be described with reference to the drawings. That is, as shown in FIG. 2, the plasma separation apparatus according to the present invention is constructed. First, the plasma introduction circuit includes a blood introduction tube 21 to be connected to a patient's artery (not shown), a surface liquid introduction pump (for example, a roller pump) 22 provided on the way, and a blood introduction tube 21 connected on the way. It consists of a side air trap 24, and the other end is connected to a blood inlet 25 of a model plasma separator 26. Note that the blood introduction side air trap 24 is connected to the blood pressure side 23 . On the other hand, the blood discharge circuit consists of a blood discharge pipe 3o to be connected to a patient's vein (not shown), and a surface fluid discharge side air trap 29 connected in the middle thereof, and the other end of the blood discharge pipe 30 is It is connected to the blood outlet 27 of the model plasma separator 26. Note that a blood outlet pressure gauge 28 is connected to the blood discharge side air trap 29 .

The plasma discharge circuit consists of a plasma discharge pipe 34 connected with a plasma side air trap 33 and a plasma discharge pump 35 installed in the middle, and one end of which is connected to the model plasma separator 2.
6, and the other end is used as an outlet or connected to a secondary plasma separator (not shown). Note that a plasma pressure gauge 32 is connected to the plasma side air trap 33. Further, the blood discharge pipe 30
includes a model plasma separator 26 and a blood discharge side air trap 3.
A plasma inlet tube 36 is connected to the intermediate point between the tube 9 and the tube 9 .

Therefore, on the plasma discharge side of the model plasma separator 26,
A cleaning liquid conduit 37 is connected to the lower part of the tank 38, and a liquid storage tank 38 filled with cleaning liquid is connected through the conduit 37. A pressure gauge 39 is connected to the liquid storage tank 38, and an air vent 40 that can be opened and closed is provided with a filter 41 if necessary.

As the plasma separator 26 used in the plasma separator according to the present invention, either a hollow fiber membrane type or a flat membrane type can be used as long as it is a model, but a flat membrane type plasma separator is preferable.

Examples of flat membrane plasma separators include those shown in FIGS. 3 and 4. In other words, there is a blood inlet 2 in the center of the bottom.
5 and a circular tubular case body 42 with a blood outlet 27 on the side wall, a lid body 44 with plasma outlet ports 31a, 31b and an O-ring 43 attached to the periphery. A flow path regulating plate and a blood flow path forming plate are housed. That is, there is an opening 45 in the center.
A circular plasma flow path forming plate 47 made of a screen mesh with plasma passage holes 46 near the periphery is sandwiched between two upper and lower circular filtration membranes 48a and 48b, and the periphery and the periphery of the central opening are The filtration membrane unit 50 is formed by sealing by heat fusion, adhesion, etc., and by pasting a sealing material 49 around the outer periphery of the plasma passage hole 46 . Here, if the circular plasma flow path forming plate 47 can secure a plasma flow path,
The above 7- is not limited to mesh. A center opening 45 and a plasma passage hole 46 corresponding to the unit 50 are provided between the plurality of filtration membrane units 50, and a large number of protrusions 54 are provided on both sides (however, the outer periphery of the passage hole 46 (The portion is flat.) A circular blood flow path regulating plate 51 is provided. Moreover, above the top and below the bottom of the filter membrane unit 50, the circular blood regulating plate 51 or the unit 50 is
It has a central opening 45 and a plasma passage hole 46 corresponding to
The outer periphery of is flat. ) The circular blood flow path regulating plate 52 is brought into contact with the convex portion thereof.

These filtration membrane unit 50 and blood flow path regulating plate 51
．． 52 are stacked one on top of the other and inserted into the case body 42, and the cover body 44 is placed and pressed to close the case body 4.
A flat membrane type plasma separator as shown in FIG. 4 can be obtained by fitting the plasma separator into the inside of the plasma separator 2 and sealing it liquid-tight with an O-ring 43. Further, due to such pressure, the filtration membrane unit 50 and the blood flow path regulating plates 51 and 52 are separated by the sealing material 49.
8 - The passage hole 4 is integrally connected at the outer circumference of the passage hole 46.
6 are connected and formed.

The filtration membranes 48a and 48b are made of cellulose esters such as organic acid esters such as cellulose nitrate and cellulose acetate, or synthetic resin membranes such as polycarbonate (thickness: 30 to 30 mm).
200 microns) by a known method such as a phase separation method, an extraction method, a stretching method, a charged particle irradiation method, etc., and the average pore diameter is about 0.1 to 1 micron.

The blood flow path regulating plates 51 and 52 are the filter membranes 48a.

48b, and has a large number of protrusions. Its Young's modulus is 1, Ox
10' ~2. Ox 10”dyne/cm2,
Good, t or 1, Qx 106~1, OX 1
The material is 0'dyne/am'. The reason for this is that when the separator is pressed to easily narrow and relax the blood flow path, the flow path plastically restores itself, making it easier to obtain the desired filtration amount. Examples of materials having a Young's modulus in this range include low-density polyethylene, silicone,
Isoprene rubber, Burel rubber, styrene-butadiene rubber (SBR), ethylene-vinyl acetate copolymer resin (EV
A) etc. Further, it is desirable that the surface hardness of the blood flow path regulating plate including the convex portion has a Shore A height of 10 to 100.

The convex portions of the surface liquid flow portion support the filtration membranes 48a and 48b to prevent deformation, and ensure a blood flow path in the gap between the convex portions. This convex part has a height of 50 to 500
A micron diameter is desirable, and a 100 to 250 micron diameter is particularly preferred. The reason for this is that if the thickness is less than 50 microns, it is difficult to adjust the channel thickness, and if it exceeds 500 microns, the deformation is large and errors are likely to occur, and the wall shear rate cannot be increased. Further, the interval between these convex portions is preferably 100 to 2.000 microns, particularly preferably 400 to 800 microns. Further, the ratio of the radius of the bottom of the convex portions, the length of a diagonal line or one side, and the distance between the convex portions is preferably 1:1 to 1:3.

(1) Specific Effects of the Invention Next, a method of using the plasma separator having the above-mentioned configuration will be explained. That is, as shown in FIGS. 2 to 4, one end of the blood introduction tube 21 constituting the blood introduction circuit is connected to a priming fluid storage tank (for example, an infusion bag) (not shown), and then the surface fluid introduction pump 22 is activated. Then, a priming solution such as physiological saline or heparinized saline is made to flow through the model plasma separator 26 to perform priming.

Next, when the air vent 4o of the liquid storage tank 38 is opened and the liquid storage tank 38 is positioned below the plasma separator 26, the priming liquid that has passed through the 81 membrane flows into the liquid storage tank 38. Therefore, when the air vent 40 is closed and the liquid storage tank 38 is raised to a higher position than the plasma separator 26, the space inside the liquid storage tank 38 is maintained at a predetermined pressure.

Next, the priming liquid reservoir is removed, and the blood introduction tube 21 is connected to the patient's artery or vein (not shown), and the blood discharge tube 30 constituting the blood discharge circuit is connected to the patient's vein. Further, when the surface liquid introduction pump 22 is operated, the removed blood is temporarily stored in the blood introduction side air trap 24 and then flows into the model plasma separator 26 from the white liquid inlet 25. This blood flows through the gap between the protrusions formed between the blood flow path regulating plate 51.53 and the filtration membrane unit 50 through the central opening 45, and flows through the filtration membranes 48a, 4.4 of the filtration membrane unit 50. 8b. The filtered plasma passes through the gap between the plasma flow path forming plates 47 in the filtration membrane unit 50, reaches the plasma passage hole 46, and is then discharged from the plasma outlet ports 31a and 31b provided in the lid 44. . On the other hand, the filtration residual liquid containing concentrated blood cells (II!
The condensed blood flows through the gaps between the blood flow path regulating plates 51 and 52 and the filter membrane units 1 to 50, and is discharged from the blood outlet 27 to the blood discharge circuit.

The plasma discharged from the plasma outlet 318.31b is discharged from the plasma discharge pipe 34 constituting the plasma discharge circuit by the action of the plasma discharge pump 35, and is temporarily stored in the plasma side air trap 33 before being discharged from the system. Alternatively, the plasma may be separated again by a secondary plasma separator (not shown). On the other hand, replacement fluid or purified plasma for diluting the blood concentrated by plasma separation is introduced from the plasma introduction pipe 36, and in the blood discharge pipe 30, the model plasma separator 26 and the blood discharge side air trap are introduced. It merges with 29 in the middle. The concentrated blood mixed with plasma in this manner is returned to the patient's vein (not shown) from the blood discharge side air trap 29 through the blood discharge pipe 30. The pressure of blood and plasma at each part is measured by blood inlet pressure gauge 23,
It is measured and monitored by blood outlet pressure gauge 28 and plasma pressure gauge 32.

Next, when the predetermined plasma separation operation is completed, the blood and introduction pump 22 are stopped, the blood introduction tube 21 is removed from the artery, and the blood introduction tube 21 is connected to a washing fluid supply source, for example, an infusion bag, and then the blood introduction pump 22 is turned on. When activated, a washing solution such as physiological saline or heparinized saline is circulated, thereby collecting blood or white blood cells remaining in the circuit from the blood introduction circuit to the blood discharge circuit via the model plasma separator 26, and draining the blood into the vein. Return to. On the other hand, in the plasma discharge circuit, when the connecting conduit 53 connecting the plasma outflow ports 31a and 31b is clamped, the air vent 40 of the liquid storage tank 38 is opened to the atmosphere, and the plasma discharge pump 35 is operated, the liquid storage tank 38 Washing solutions such as physiological saline and heparin flow into the model plasma separator 26 from one plasma outlet 31b through the conduit 37, and then are discharged into the plasma discharge circuit from the other plasma outlet 31a. The plasma remaining in the area is collected. Then, it is returned to the collected plasma and blood discharge circuit through the plasma introduction tube 36. In this case, a sterilization filter may be installed in the air vent 40 to prevent contamination due to sterilization or the like.

Furthermore, after attaching an air syringe for air discharge to the blood discharge side air trap 29 and clamping between the air trap 29 and the venous side of the blood discharge pipe 30, air is injected from the open end of the blood introduction pipe 21. The blood remaining in the circuit is collected and stored in the blood discharge side air trap 29, and the air is discharged by an air syringe.Next, the clamp is removed and the blood remaining in the air trap is collected. The blood collected in the blood is returned to the veins.

■3 Effects of the Invention As described above, the plasma separation ll1lt device according to the present invention has a model plasma separator equipped with a blood inlet, a concentrate outlet, and a plasma outlet, and a blood inlet circuit and a blood outlet circuit, respectively. and a plasma discharge circuit, in which a conduit is connected to the lower part and a liquid storage tank filled with a washing liquid is connected to the plasma discharge side of the model plasma separator through the conduit. After the plasma separation operation is completed, the plasma remaining on the plasma side of the model plasma separator, which was previously impossible or difficult to collect, can be removed by letting the cleaning solution in the storage tank flow down. It has the advantage of being almost completely recoverable. Furthermore, since the liquid storage tank is configured to be able to communicate with the atmosphere, by communicating with the atmosphere during plasma collection, the cleaning liquid in the liquid storage tank can flow down naturally. Furthermore, if the cleaning liquid in the liquid storage tank is the priming liquid introduced from the blood introduction circuit, the priming liquid used to prime the entire circuit using the model plasma separator immediately before use can be transferred to the separator. After being discharged through the filtration membrane 15, the liquid can be stored in the liquid storage tank, which makes the operation extremely simple and inexpensive. Furthermore, by using a flat membrane type model plasma separator, loss of blood cells is reduced. Further, at least two plasma discharge ports are provided in the model plasma divider, and the plasma separator is arranged such that the plasma discharge ports are in a vertical positional relationship, and the conduit connected to the liquid storage tank is connected to one side. If the plasma discharge port is connected to the plasma discharge port located above the plasma discharge port, the washing liquid flowing from one plasma discharge port will pass through the plasma flow path in the model plasma separator and be discharged from the other plasma discharge port. Because it is discharged,
There is an advantage that plasma remaining in the basin can be almost completely recovered during this time.

[Brief explanation of the drawing]

Figure 1 is a circuit diagram of a conventional plasma separation device, and Figure 2 is a plasma separation device according to the present invention! 3 is an exploded perspective view showing an example of the flat membrane plasma separator used in the present invention, and FIG. 4 shows the assembled state of the separator shown in FIG. 3. FIG. 16- 21...Blood introduction tube, 22.35...Pump, 2
4.29.33...Air 1~Lap, 23,28°3
2.39...Pressure tear, 25...Blood inlet, 26
...Model plasma separator, 27...Blood outflow port, 30
...Blood discharge tube, 31a, 31b...Plasma discharge port, 34...Plasma discharge tube, 36...Plasma introduction tube, 3
7... Conduit, 38... Liquid storage tank. Patent Applicant Teru Seven Co., Ltd. 18-

Claims (5)

[Claims] (1) A plasma separator in which a blood introduction circuit, a blood discharge circuit, and a plasma discharge circuit are respectively connected to a deformed plasma separator equipped with a blood inlet, a concentrated blood outlet, and a plasma outlet, 1. A plasma separation device, characterized in that a liquid storage tank having a conduit connected to the lower part and filled with a washing liquid inside is connected to the surface plasma discharge side of the deformed plasma separator via the conduit. (2) The plasma separation device according to claim 1, wherein the liquid storage tank is configured to be able to communicate with the atmosphere. (3) The plasma separation device according to claim 1 or 2, wherein the washing liquid is a briming liquid introduced from the blood introduction circuit. (4) The plasma separation device according to any one of claims 1 to 3, wherein the deformed plasma separator is a flat membrane type plasma separator. (5) The number of plasma discharge ports is small (both are provided on two sides, and the conduit connected to the liquid storage tank is provided so as to communicate with the plasma discharge port located above one plasma discharge port). The plasma separation device according to any one of Items 1 to 4.