JPS58149763A - Purifier for body liquid - 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 The present invention relates to a body fluid purifier for adsorbing and removing unnecessary substances or poisons from body fluids such as blood or plasma separated from blood. More particularly, the present invention relates to a body fluid purifier in which the amount of adsorbent fine powder that flows out into body fluids during use is small.

Recently, much effort has been made to develop body fluid purifiers that adsorb and remove harmful substances from body fluids by bringing adsorbents such as activated carbon and ion exchange resins into direct contact with irrigation fluids. Among these, those using activated charcoal have been developed for the longest time, and have already been put into practical use for the treatment of drug poisoning and hepatic coma.

Normally, in such body fluid purifiers, particulate adsorbent with a particle size of approximately 1/2 m is used because it is necessary to ensure a flush adsorption surface and a free flow. It is used by being filled into a synthetic resin cylindrical container equipped with a filter. The blood drawn outside the body adsorbs and removes harmful substances while flowing through channels formed as gaps between particles of the filled adsorbent, and the purified blood is returned to the body for treatment.

However, adsorbents, including activated carbon, generally have low abrasion resistance and tend to generate fine particles. When these fine adsorbent particles are released, they are carried into the body by the bloodstream and block peripheral blood vessels. However, if the amount is excessive, it will deposit in tissues such as the lungs and liver, causing various disorders.

Activated charcoal was first studied for the purpose of treating uremia and drug addiction, but the above-mentioned drawbacks prevented it from being widely applied clinically. The reason why it has come into practical use today is that a method was developed to suppress the generation of fine powder by coating activated carbon with a polymer such as nitrocellulose. This is because it has become possible to prevent this.

However, although this method has made it possible to considerably suppress the outflow of activated carbon fine powder from the filling container, body fluid purifiers currently do not allow for drug poisoning or drug poisoning due to the small amount of fine powder generated. It is used only in cases such as hepatic coma where the therapeutic purpose can be achieved with just a few uses, and for diseases such as chronic renal failure that require frequent treatment over a long period of time. Its use is not yet generally accepted.

The present inventors also conducted extensive research to further reduce the amount of fine powder flowing out by covering the adsorbent with a polymer membrane such as nitrocellulose or ethylhydrochiraethylcellulose and filling it into a 1 g container. No results were obtained. This is due to the fact that a non-negligible amount of fine powder is generated during the coating operation and remains on the surface of the adsorbent particles on the bales to be treated. This is thought to be caused by the release of

The inventors of the present invention further investigated the method of preventing the outflow of fine powder under #glI, and found that when the container is heat-treated after filling the container with particulate adsorbent, It was found that the amount of adsorbent fine powder flowing out was reduced to 1 light, and the effect was maintained as long as the adsorbent was pressed with a filter after heat treatment.

That is, an object of the present invention is to provide a body fluid purifier that can reduce the amount of particulate adsorbent mixed into body fluid during use and prevent the adverse effects of adsorbent fine powder on living organisms.

In order to achieve the above object, the present invention provides a cylindrical container having an inlet at one end and an outlet at the other end. The body fluid purifier is a body fluid purifier filled with an adsorbent, and the body fluid purifier is heat-treated, and the particulate adsorbent-filled bed is moved by the above-mentioned filter, which can be stopped at any position depending on the bed height. This body fluid purifier is characterized by being pressed.

Hereinafter, the cylindrical container may be referred to as a container, and the cylindrical container filled with particulate adsorbent may be referred to as an adsorption tube.

By configuring as described above, in the present invention,
When a cylindrical container is filled with particulate adsorbent and the container is heat-treated, the container undergoes a process of thermal expansion and returns to its original size, which makes the adsorbent packed densely and allows it to be absorbed during body fluid perfusion. As a result of no frictional force being generated on the agent particles, release of adsorbent fine powder into body fluids is prevented.

As a result of the heat treatment, the adsorbent is packed tightly and the height of the packed layer of the installed adhesive is lowered accordingly, but in order to maintain the adsorbent in a tightly packed line during use, in the present invention, the particulate adsorbent is The packed bed is pressed by a filter that can be stopped at any position depending on the bed height.

Body fluid purifiers that use adsorbents are usually sterilized by heat sterilization, where there is no risk of the adsorbent adsorbing sterilizing agents or gases.
Although sterilization is performed, this heat sterilization and the heat treatment of the present invention have essentially different purposes and should be distinguished from each other.

In other words, the jujusho S of the present invention uses a container of jl1gI! Since the purpose is to increase the temperature, the duration does not matter as long as the device reaches a predetermined temperature.

An embodiment of the body fluid purifier according to the present invention will be described in detail below with reference to the accompanying drawings.

# In the I1 diagram and the Is diagram, the cylinder l is a container body, into which particulate adsorbent λ is filled.

Boat parts 3, 3 at the ends of the cylindrical body 1 for introducing or discharging body fluids are slidably fitted in close contact with the inner surface of the cylindrical body via elastic bunks. cap! , j are screwed in from the outside of the cylinder l and are attached to the boat part 3.3.
It can be stopped at any position by pressing .

a filter a with a mesh size smaller than the particle size of the adsorbent;
This filter 6 is placed inside the t* boat part 3.3.
receives the pressing force from the cap part via the boat part 3 and presses the entire layer of particulate adsorbent. If necessary, a filter reinforcing porous plate 7.7 is provided between the boat parts 3, 3 and the filters J, G to press the adsorbent layer. This prevents deformation and protrusion, thus preventing weakening of the pressing force by the filter 6.6. In this case, the perforated plate 7゜7 itself is the filter 6.6
There is no need to provide separate reinforcing means as long as the pore diameter is small enough to function as a container and it is difficult to deform. It is preferable to make the range l as large as possible. Thereby, the necessary pressing force can be applied and adjusted in response to variations in the filling degree of the drug.

The adsorbent used in the body fluid purifier of the present invention may be any type of adsorbent, such as activated carbon, ion exchange resin, or a mixture thereof, as long as it is in particulate form. It is desirable that the average particle size is in the range of 0.3~! a
m, preferably 423 to 3 yen.

First, the adsorbent is sieved and classified, and then fine powder adhering to the adsorbent is sufficiently washed away by ultrasonic cleaning, boiling water washing, running water washing, etc. The end of the container from which the cap j, elastic backing 39, and filter 6 (including the reinforcing perforated plate 7 if necessary, the same shall apply hereinafter) on one side of the container is facing upward, and the filter, elastic backing, and boat The particulate adsorbent that has been thoroughly washed is poured into the container together with water from above while the container is placed in an upright position with the other end with the cap and the other end facing down, and the container is vibrated.

Once the appropriate amount has been filled, install the filter and elastic backing on the top end, push in the boat, and then screw in the cap until you feel rotational resistance.

Then, after sealing the adsorption cylinder by appropriate means, /2
Heat treatment is carried out for 10 minutes using high pressure steam at /''C. This heat treatment causes the particulate adsorbent to be tightly packed and the height of the classified adhesive packed bed is reduced. Screw in the caps j and j at both ends respectively.This moves the filters 6 and t and presses the adsorbent packed layer.This pressing force is determined by the force with which the caps 6 and t are screwed in, and that force is used. 1ml of adsorbent
m can be appropriately determined depending on the particle size and container. Further, the heat treatment and the screwing process of the caps 6 and B are not limited to the same process, but must be repeated until the caps A and A no longer rotate even if a predetermined rotational force is applied. In addition, if there is a risk that the cap 6.6 may loosen naturally, the cap t,
It is preferable to fix the t and the cylindrical body by a method such as gluing.

The method for moving the filter 7j after heat treatment has been described above as an example, but there are other methods for moving the filter 7j between the caps Z and S and the boat part 3.3, or between the boat part 3.3 and the filter 6,
It is also possible to press the adsorbent layer with the filters A and G using the elasticity of an elastic body interposed between the filters A and G. In this case, the operation of screwing in the heat treatment S11 cap 6.6 can be omitted.

Furthermore, even if an identification type filter is used without relying on the present invention, it is possible to press the adsorbent packed layer with the filter by additionally filling the particulate adsorbent after heat treatment and fixing the filter. However, this method requires an additional operation to add adsorbent and has the drawbacks that it is only possible to measure the pressing force.

The body fluid purifier of the present invention can be sterilized by conventional heat sterilization. If you use the method of pressing the adsorbent-filled bed with the filter by moving the filter, the heat treatment and cap screwing steps are repeated as necessary, and the camp will not hold even if a specified rotational force is applied. Heat sterilization may be performed after the adsorption column is prevented from rotating, but in this case, it is desirable that the heat treatment temperature is at or above the temperature at which the adsorption column is exposed during heat sterilization. Further, in the case of using a method of pressing the filter using the elasticity of an elastic body, it is also possible to combine the heat treatment of the present invention with heat sterilization.

In any of the above cases, the sterilized l@adhesive packed bed is pressed by a filter and the particulate adsorbent is kept tightly packed, so the amount of fine powder newly generated during body fluid perfusion is negligibly small. Therefore, if the fine adsorbent powder generated during heat sterilization is washed and removed by pouring about 2 liters of physiological saline into the adsorption column before use, and then perfused with body fluid, the fine adsorbent powder will be transferred into the perfusion fluid. The amount of contamination will be extremely small.

Incidentally, during heat sterilization, adsorbent fine powder is thought to be produced in the following manner. That is, in the same way as during the heat treatment of the present invention, the heated container expands, and shrinks to its original size before the heating ends and the temperature returns to room temperature. As the container expands and contracts, the adsorbent packed bed also undergoes expansion or contraction pressure changes, and as a result, frictional force is generated on the adsorbent particles and fine powder is produced. When the adsorption cylinder is sterilized by heat sterilization in this way, the dimensions of the container inevitably change, and new adsorbent fine powder is generated. Although most of the adsorbent fine powder present in the adsorbent packed bed in a 7-liquid state is removed by flowing 1 liter of water through the adsorption column, it is not completely removed. Therefore, as a method for sterilizing the body fluid purifier of the present invention, it is preferable to use a sterilization method that causes almost no change in the dimensions of the container. In other words, if the adsorption column is sterilized by the above sterilization method after the heat treatment of the present invention is completed, clean water is poured through the adsorption tube to remove the fine adsorbent powder generated as a result of the heat treatment, and the adsorption tube is sterilized by the above sterilization method. Since the adsorbent fine powder present in the state is almost completely removed, washing with physiological saline before use, which is required in the case of heat sterilization, can be omitted, and adsorption that cannot be removed even after washing can be omitted. This prevents the fine powder from mixing with body fluids.

Gamma ray sterilization is suitable as such a sterilization method. In this case, when the material of the container and the adsorbent particles are coated with a polymer layer, it is of course necessary that the coating material not be adversely affected by gamma sterilization.

For example, polycarbonate resin is preferably used for the cylinder for this purpose.

The present invention will be further explained below with reference to Examples.

In the following Examples and Comparative Examples, the adsorbent used was activated carbon (BAOMU) manufactured by Kureha Chemical Co., Ltd., which had a sphere shape with an average particle size of θ; The activated carbon fine powder adhering to the activated carbon particles was removed by ultrasonic cleaning, boiling cleaning, and running water cleaning before use.

In addition, the container to be filled with the above-mentioned activated carbon has a content capacity of 33 (33) having a structure as shown in FIGS.
The polycarbonate sea bream container of II was used with a perforated plate for reinforcing the filter.

Example 1 An adsorption tube was prepared by filling the container with washed activated carbon izog and water while lifting the container upright, and tightening the caps at both ends until rotational resistance was felt. Next, this adsorption cylinder was subjected to high pressure steam sterilization*a to 727
Heat treatment was performed using high pressure steam at ℃ for /θ minutes. Thereafter, the cap was screwed in with a predetermined rotational force and then heat treated again under the same conditions. After applying rotational force to the cap again, the cap no longer rotated. Therefore, the adsorption cylinder /2/IC
High-pressure steam sterilization was performed for 1-0 minutes to obtain a sample for evaluation test. Although a predetermined rotational force was applied after the evaluation test was completed, the cap did not rotate.

Comparative Example 1 After filling a container with activated carbon in the same manner as in Example, the cap was tightened with the same rotational force as applied to the cap after heat treatment in Example 7 to create an adsorption cylinder. This adsorption cylinder was then autoclaved at 727°C for 20 minutes.
A sample for evaluation test was obtained.

Example λ The adsorption cylinder was heat-treated twice in the same manner as in Example 1, and clean water was poured at a flow rate of 00000 ml per minute into the adsorption cylinder whose cap did not rotate even when a predetermined rotational force was applied. Washed for hours. The sample was then sterilized by irradiation with gamma rays to obtain a sample for evaluation testing.

Evaluation Test An evaluation test was carried out by measuring the number of activated carbon fine powder released from the adsorption column for the three samples mentioned above using the test apparatus shown in FIG.

In Fig. 3, the water leaving the reservoir /4t is passed through a membrane filter 73 with a pore diameter /, 0 microp by a roller pump l-, and then passes through an adsorption cylinder // with a pore diameter /,
It is filtered through a 2 micron membrane filter and returned to the reservoir 14! Go back and vote 11. Released from the adsorption cylinder into the circulating water /, -2i Chloro 2 or more activity [1 powder is on the membrane filter-is &:! Therefore, by counting the number of fine activated carbon powders on the membrane filter after circulating water for a certain period of time, the number of fine activated carbon powders liberated during that time can be measured.

In the evaluation test, water was circulated at a flow rate of λOo- per minute, and the initial i
Membrane filter for o minutes and every hour thereafter
J was replaced, and the liberated activated carbon fine powder was captured on each filter. The number of activated carbon fine powders was counted using a 10x optical microscope. The results are shown in Table 1.

Table 7 Number of free coal dust Unit pieces

[Brief explanation of the drawing]

1 and 2 show an embodiment of the body fluid purifier according to the present invention, FIG. 1181 is a perspective view, FIG. 2 is a vertical sectional view of the body fluid purifier shown in FIG. 7, and FIG. FIG. 2 is a system diagram of a system for measuring the amount of fine powder flowing out. l...Cylinder C...Adsorbent 3.3...Port part T, 3...Elastic packing j, j...Cap 6.6...Filter 7.7...・Reinforcing perforated plate t, r...port inner cavity//...--adsorption tube l...-
...Roller pump/3... Membrane filter/l... Reservoir/j... Membrane filter/6... Filtration container IGI

Claims (1)

[Claims] 111 Particulate adsorbent filled between filters provided inside each of the inlet and outlet in a cylindrical container having an inlet at one end and an outlet at the other end. The body fluid purifier is a layered body fluid purifier, and the body fluid purifier is heat-treated, and the particulate adsorbent packed bed is pressed by the filter that can be stopped at any position depending on the bed height. Features body fluid purifier. (2) The body fluid purifier according to item (+1) of the patent application, characterized in that it is sterilized by gamma ray sterilization.