JPH0221871A - Disposable set for fractioning and removing liquid component from liquid mixture - Google Patents

Abstract

PURPOSE:To continuously and easily fractionate and remove a desired component under sterilization from various liquids by enabling a liquid mixture to circulate from an outlet port of a container through a fraction remover and then return into the container through a circulation inlet port, and by isolating the interior of a disposable set in its entirety from the exterior under sterilized condition. CONSTITUTION:A raw liquid fed from a storage section A through an inflow pipe 1 and a second liquid fed from a storage section B through an inflow pipe 2 are mixed into a liquid mixture which is then introduced into a storage space 6 in a container 5. The liquid mixture is fed from a discharge port of the storage space 6 into a fraction remover 10 through an inlet pipe 9 by means of a drive pump disposed in a circulation pipe 8, and then a component fractioned and removed from the mixture by means of a hollow fiber membrane is introduced into a reserving section C through a discharge pipe 11. The remaining part of the liquid mixture is returned into the storage space 6 through a return pipe 13 and a return port 14. The above-mentioned circulation of the liquid mixture is continuously carried out by means of the drive pump and the like until a desired liquid component can be fractioned and removed from the raw material, and the interior of the set can be isolated from the exterior under a sterilized condition.

Description

Detailed Description of the Invention (Industrial Application Field) The present invention is for sterilizing and continuously separating and removing desired components from a mixture of an original liquid and a second liquid contained in a container. Regarding disposable sets. More specifically, for example, the collected blood may be diluted with a second solution such as physiological saline.
The present invention relates to a disposable set that is preferably used to mix with liquid, wash, and separate and remove blood preservatives, plasma components, etc. in a continuous and sterilized manner.

(Prior art and its problems) As means for separating liquid components, sedimentation methods, centrifugation methods, methods using separation membranes, etc. are known.

In particular, the collected blood is washed with a second liquid such as physiological saline,
Specific methods for separating and removing blood preservatives and plasma components include Yukio Sumida's Clinical Blood Transfusion, pages 207 to 223 (Kinzoku Publishing, 1978), Frozen Blood Transfusion, Nippon Medical Newspaper, pages 59 to 80. (1971), etc. (the former method), and the centrifugation method currently practiced at blood centers in various places (the former method).
The latter method) is available.

However, in all of these methods, the addition of the second liquid and the separation and removal of the desired components to be separated are performed intermittently;
The operation is complicated and requires manpower, and the work takes a long time.

Furthermore, since the former method is carried out in an open system, contamination with bacteria, bacteria, viruses, etc. in the atmosphere is unavoidable.

Even in the latter method, addition of the second liquid requires puncturing operations as many times as necessary for washing, and as mentioned above, in order to separate and remove the components to be separated, intermittent centrifugation operations must be performed as many times as necessary. It won't happen. In other words, in order to separate and remove three times, the addition of the second liquid and the centrifugation operation must be repeated three times, which requires manpower and a long time, and there is a risk of contamination by bacteria during these operations. , there is also a high possibility of contamination.

As mentioned above, there has not yet been a simple and practical disposable set that uses a second liquid to separate and remove desired components from collected blood in a substantially sterile manner in a simplified continuous operation. .

In addition, in the centrifugation method, there was a technology that uses a second liquid to continuously separate and remove the desired components from collected blood, but this method requires a complicated and expensive disposable set and is expensive. Although it was put into practical use, it did not become widespread because it required specialized equipment and was complicated to operate, leading to the intermittent centrifugation method being widely used as described above.

(Objective of the Invention) The object of the present invention is to solve the above-mentioned problems in the conventional method, and to use a second liquid to collect raw materials such as collected blood and platelet fluid in a simple continuous operation and under sterilized conditions. To provide a simple and practical disposable set for separating and removing desired components to be separated from a liquid.

(Structure of the Invention) The gist of the present invention is that the container 5 has a mixed liquid outlet 7 at the lower part, a mixed liquid circulation return path inlet 14 at the upper part, the raw liquid inflow pipe 1 and the second liquid inflow pipe 2, and the inside thereof. A separation/removal device 10 containing a separation membrane and equipped with an outflow pipe 11 for components to be separated/removed on the side is connected by a circulation pipe 8 between the mixed liquid outlet 7 and the inlet pipe 9 of the separation/removal device. The outlet pipe of the separation/removal device and the mixed liquid circulation return path inlet 14 are connected by the circulation return path pipe 13, so that the mixed liquid in the container 5 flows from the outlet 7 through the separation/removal device 10 to the circulation inlet. This disposable set is for separating and removing liquid components from a mixed liquid, and is characterized in that the set can be circulated through the liquid mixture into the container through the liquid mixture 14, and the entire inside of the set is kept sterilized from the outside world.

Please note that the following explanation of the set of the present invention will be explained in more detail below. As shown in FIG. 5, a hollow fiber valve is used as an I membrane! ! Although a membrane was used, the separation membrane that can be used may be of any type, such as a plain clothes type or a cylindrical type. In addition, as a method of bringing the mixed liquid of the original liquid and the second liquid into contact with the surface of Km to generate shear stress between the two, the mixed liquid may be passed through the surface of the separation membrane, or the separation membrane itself may be mixed. It can also be moved in liquid. In the former case, in addition to a method in which the mixed liquid is moved by a circulation pump, a method in which the mixed liquid is stirred on the surface of a separation membrane, a non-powered filtration method that utilizes the difference in gravity within the system, etc. are used. In the latter case, a method is used in which the separation membrane is processed into, for example, a cylindrical shape and rotated in the mixed liquid.

Minute! l1ff! Any type of liquid can be used as long as it can separate and remove desired liquid components. For example, if the desired liquid component to be separated and removed is a blood preservative, a separation membrane with a pore size of approximately 0.01 μm or less is used, and if the liquid component is a plasma protein component, a separation membrane with a pore size of approximately 0.1 μm to 0.7 μm is used. Just use it. Any membrane material can be used as long as it does not cause clogging due to liquid components. Although the separation membrane area is not particularly specified,
In the case of a fixed membrane type, it is practically preferable to have an area of around 0.1 m2 or more, and in the case of a membrane driven type, it is practically preferable to have an area of around 0.005 m2 or more.

The present invention will be explained below with reference to the drawings. 1 to 3 show an example of the set of the present invention. The raw liquid is delivered from the reservoir A by the inlet pipe 1 and the second liquid is delivered from the reservoir B by the inlet pipe 2. The raw liquid and the second liquid become a mixed liquid and enter the storage chamber 6 of the container 5 through the inlet 3. The mixed liquid container 5 has an outlet 7 at the bottom and an inlet 14 at the top.
It is used in a suspended state through the suspension hole 4. Between the outlet 7 and the inlet 14, there is a separation/removal device l.
The circulation pipe 8 and the circulation return pipe 13 are connected via O. The separation/removal device 10 consists of a container 12 containing a bundle of hollow fibers, and an outflow pipe 11 connected to a storage section C for components to be separated/removed.
have. The mixed liquid in the storage chamber 6 enters the separation/removal device 10 via the inlet pipe 9 from the outflow port 7 by a driving bomber installed in the circulation pipe 8, and the components separated and removed by the hollow fiber membrane are passed through the outflow pipe 11. After that, it enters storage section C.

The remainder of the mixed liquid is passed through the circulation return pipe 13 to the returning person "J".
Return to containment room 6 from 14.

One of the features of the set of the present invention is that the above-mentioned mixed liquid is circulated by a drive pump or the like until a predetermined target is achieved.
That is, the process can be carried out continuously until the desired liquid components are separated and removed from the raw liquid. Another feature of the set of the present invention is that the entire inside of the set is kept sterilized from the outside world.

Second liquid storage section B and separated/removed component storage section C in Fig. 3
As shown in , the entire inside of the set is kept sterilized from the outside world by the sterilization ventilation section A. Therefore, during the operation bacteria,
There is no risk of contamination or contamination with viruses, etc.

FIG. 4 shows another embodiment of the set of the present invention, in which the raw liquid directly flows into the storage chamber from an inlet 31 and the second liquid directly from an inlet 32, and furthermore, a stirring mechanism 15 is provided in the container 5. It is provided with a seal 16. By providing a stirring mechanism, separation and removal efficiency is further improved. FIG. 5 is an explanatory diagram focusing on the separator/removal device 10. As shown in FIG. The mixed liquid flowing in from the inlet pipe 9 is separated by a hollow fiber type separation membrane, and desired separated components are separated outside the hollow fiber membrane and flowed out from the outflow pipe 11. The mixed liquid from which the fractionated components have been removed returns to the container 5 through the circulation return pipe 13.

In addition, in the above description, the case where the original liquid and the second liquid flow into the container 5 from the storage section, respectively, has been described.
The original liquid may be placed in the container S in advance, and the second liquid may be introduced into the container S.

Furthermore, a filter for removing minute aggregates, specific blood cell components, etc. can also be installed in the mixed liquid circulation path. Further, a container for transferring the mixed liquid after removing the components to be separated may be attached to the circulation path or the mixed liquid storage chamber. Next, a specific example using the set of the present invention will be shown.

While removing the saline containing serine, add s to this stuff.
saline at an average inflow rate of um/min for approximately 1 hour 30
Added minutes. The final volume and glycerin content of the mixture were about 1.11 and less than 1%, respectively. A polysulfone hollow fiber type separator with an average pore diameter of about 0.02 μm and a membrane surface M of 0.7 m 2 was used as the separator. Examples with different stock liquid compositions are shown in the table below.

(Example) Thawed concentrated red blood cell fluid (CRC) containing about 30% glycerin as stock liquid1. OIl was placed in a 3J2 (7) PVC bag-like container, and a mixed solution containing 300 mJZ of physiological saline as a second liquid was circulated between the container and the separator using a circulation pump. From the separator to the grid 6 and the storage chamber 7. Outlet 8, circulation pipe 9, separation/removal inlet pipe 10, separation/removal unit 11, separated/removed component outflow pipe 12, separation/removal container 13, circulation return pipe 14, circulation return inlet 15, stirring mechanism 16 , seal part A, raw liquid storage part B, second liquid storage part C1, separated/removed component storage part A, sterilization vent port, drive pump 31, raw liquid inlet 32, second liquid inlet (of the invention) Effects) According to the set of the present invention, desired components in various liquids can be easily separated and removed aseptically and continuously.

[Brief explanation of the drawing]

Figures 1 to 3 show one embodiment of the disposable set of the present invention. Figure 1 is a schematic diagram of each component viewed from the side, and Figure 2 is a schematic diagram of the components viewed from above. Another schematic diagram, FIG. 3, is a system explanatory diagram. FIG. 4 is a schematic diagram of each component of another embodiment of the present invention, viewed from above laterally. FIG. 5 is a schematic explanatory diagram of the separation/removal mechanism in the circulation path. Raw liquid inflow pipe Second liquid inflow pipe Mixed liquid inlet Suspension hole container Fig. Fig. O Fig.

Claims (1)

[Claims] Mixed liquid outlet 7 at the bottom, mixed liquid circulation return inlet 1 at the top
4, a container 5 equipped with an original liquid inflow pipe 1 and a second liquid inflow pipe 2, and a separation/removal device 10 which houses a separation membrane inside and is equipped with an outflow pipe 11 for components to be separated and removed on the side. , a circulation pipe 8 is connected between the mixed liquid outlet 7 and the inlet pipe 9 of the separation/removal device, and a circulation return pipe 13 is connected between the exit pipe of the separation/removal device and the mixed liquid circulation return path inlet 14. , the mixed liquid in the container 5 can be circulated from the outlet 7 through the separation/removal device 10 and into the container through the circulation inlet 14, and the entire inside of the set is kept sterilized from the outside world. A disposable set for separating and removing liquid components from mixed liquids.