JPH03280966A - Medical filter and medical injection circuit - Google Patents

Abstract

PURPOSE:To obtain a medical filter, in which no blinding is caused even when a fine colloidal deposition substance is generated in injection liquid, by charging the filter with polymer grains of 5 to 1000mum grain size, having pyrogens- adsorption activity, as a filter material. CONSTITUTION:A medical filter, charged with polymer grains 2 of 5 to 1000mum grain size having pyrogens-adsorption activity as a filter material, is constituted. This medical filter is used by filling a column 1 with the vinyl pyridine polymer grain 2 to allow body injection liquid to pass through the column 1, but nets 3, 4 with smaller mesh than the size the vinyl pyridine polymer grain 2 for preventing its outflow are provided in the up and downstreams of the column 1. This vinyl pyridine polymer grain 2 completely adsorbs gram-positive microorganisms such as Bacillus subtilis, staphylococci, enterococci, etc., and gram-negative ones such as Escherichia coli, Pseudomonas aeruginosa, etc., and virus or the like and pyrogens which can not be removed by physical filtration can be adsorptively removed.

Description

Detailed Description of the Invention [Industrial Field of Application] The present invention is a medical device for removing and sterilizing pyrogens used when injecting medical injection fluids such as nutritional infusions and blood transfusions into body cavities such as blood vessels. This invention relates to medical filters and medical injection circuits.

[Conventional technology] Conventionally, as a medical sterilization filter for infusions, etc.
．． Bacteria were removed by physical filtration using a filter with micropores of about 22 to 0.4 μm.

However, in this case, since the filter openings are small, it may not be possible to use a fat emulsion, for example, as a high-calorie nutritional infusion, as it will cause clogging.

Furthermore, when attempting to add a drug to an infusion, colloidal particles often precipitate when mixed with the infusion and clog the filter. Therefore, such medicines are injected from a circuit after the filter, and in this case there is a risk that bacteria may enter from the medicine solution.

Additionally, it would be convenient to use a bag containing all the prescriptions necessary for infusion from the beginning, but even in this case, fine particles may be generated during mixing or when the temperature drops, so physical filtration is not necessary. Filters have the disadvantage that back regions cannot be used.

However, the biggest drawback of conventional physical sterilization filters as medical filters is that they cannot remove pyrogens derived from the secretions of microorganisms, so physical filtration cannot sterilize them. Even if this is possible, the patient may develop a fever after infusion, which significantly impairs the effectiveness of high-calorie infusion therapy.

L Problem to be Solved by the Invention 3 The present invention is capable of adsorbing only bacteria and pyrodiene even if fine colloidal precipitates are generated in an infusion solution such as an infusion solution.
The object of the present invention is to provide a medical filter that does not cause clogging and a medical injection circuit using the same.

[Means for Solving the Problems] The present inventors have discovered that in order to avoid clogging due to fine particles or emulsified particles that precipitate during the mixing of pyrodiene and different components in the above-mentioned infusion solution, it is necessary to use coarse filtration instead of physical filtration. We thought that the only possible method was to use a filter medium that adsorbs bacteria and pyrodiene, and as a result of intensive research, we found that if a pyrodiene adsorption polymer such as vinyl pyridine polymer was made into particles and used in the filter medium part, it would prevent clogging. It was discovered that bacteria and pyrodiene can be adsorbed and removed without causing any problems, and based on this knowledge, the present invention was completed.

That is, the present invention provides a medical filter filled with polymer particles having a particle size of 5 to 1100 ott and having a pyrodiene adsorption ability as a filter medium, and further, in this filter, the polymer particles having a pyrodiene adsorption ability contain a vinylpyridine structural unit. A circuit containing components such as a medical filter made of polymer particles, an infusion tank, an infusion tube, a flow rate regulator, a sterilization filter, a catheter, etc. as a filter medium of the sterilization filter.
A medical injection circuit characterized in that the circuit is filled with polymer particles having a pyrodiene and seedling adsorption capacity of 1000 μm, and further, in this circuit, the pyrodiene and seedling adsorption capacity polymer particles are polymer particles containing a vinylpyridine structural unit. A medical injection circuit is provided.

Vinylpyridine polymer, which is used as a typical polymer with pyrodiene adsorption ability used in the present invention, is already known to have the ability to remove bacteria and viruses from wastewater, drinking water, etc. There are, but
It is not known that this method can be applied to solutions or emulsions containing other components such as infusions.

Furthermore, it is not known that this vinylpyridine-based polymer has pyrodiene adsorption ability.

The vinylpyridine polymer used in the present invention is a polymer of vinylpyridine or its derivative, or a polymer copolymerized with other monomers copolymerizable with vinylpyridine, and has a pyridine group in the side chain. , can be used particularly sparingly.

As the monomer that can be copolymerized with vinylpyridine, for example, monomers that can be radically copolymerized such as styrene and (meth)acrylic acid ester can be suitably used. Additionally, small amounts of reactive crosslinking agents such as divinylbenzene can be copolymerized.

For example, a copolymer of vinylpyridine and styrene, which is crosslinked using a small amount of divinylbenzene as a crosslinking agent, is particularly suitable.

The vinyl pyridine polymer used in the present invention is not particularly limited in its usage form, but it is efficient to use it in the form of fine particles with a particle size of 5 to 1000 μm, preferably 10 to 400 μm.

If the particle size becomes too small, the filtration rate will decrease, and if it is too large, the adsorption efficiency of the filter's absorbent material will decrease.
The filter volume becomes large, which is inconvenient.

Furthermore, the porosity of the surface can be adjusted in various ways depending on the conditions of use.

The present invention is characterized by the fact that the vinyl pyridine polymer, which has been used to sterilize pure water, is used in an infusion containing many ingredients, and is used not only for sterilization but also for the removal of pyrodiene.

As shown in FIG. 1, the medical filter of the present invention is used by filling a column 1 with vinylpyridine polymer particles 2 and passing a liquid injected into the body through this column 1. , in order to prevent the outflow of the vinylpyridine polymer particles 2, a mesh net 3.4 having a diameter smaller than that of the particles is provided.
It is desirable to have a

The length and diameter of the packed column of the filter of the present invention can be appropriately selected by testing the sterilizing effect of the filtrate through trial and error, depending on the type and flow rate of the injection fluid.

The vinylpyridine polymer particles used in the present invention can completely adsorb Durham-positive bacteria such as Bacillus subtilis, Staphylococcus aureus, and Enterococcus, Durham-negative bacteria such as Escherichia coli and Pseudomonas aeruginosa, and microorganisms such as viruses.

Furthermore, the vinylpyridine polymer of the present invention can adsorb and remove pyrodiene (pyrogen) that could not be removed by physical filtration.

As a polymer having the ability to adsorb pyrodiene, anion exchange resins, cation exchange resins, etc. can be used in addition to vinyl pyridine polymers.

The present inventors tested the pyrodiene removal effect using two milliliters of the commercially available polys listed in Table 1, and obtained the results shown in Table 2.

In the table, the symbol "-" indicates that the test result was negative in the Limulus single test, which means that there is a removal activity. + is the opposite, and samurai is in the middle.

In this experiment, the pyrogen removal function test was performed using the Limulus single test described below.

[Limulus Single Test]

Using the E. coli reference endoxin in Limulus test kit manufactured by Wako Pure Chemical Industries, Ltd., 0, 1 my/
ml of endoxin standard solution was prepared.

Put a predetermined amount of the test sample into a 5I volume 7 alf/V, add 0.1 rng/mΩ of 21 prepared above, stir, and incubate for 3 hours. Verified with test reagent.

(Left below) As shown in Table 2, there are few polymers that have the ability to adsorb pyrodiene, and even among polymers of the same type, there are some that have some adsorption ability and others that do not, so it is difficult to understand the behavior of substances that are involved in microorganisms. It is difficult to determine the presence or absence of adsorption ability from the polymer structure or the properties of the side chain groups.

Therefore, the polymer having a pyrodiene function to be used as the filter medium of the filter of the present invention is tested for its pyrodiene adsorption ability by, for example, the Limulus single test, and a polymer having an adsorption ability is selected. It can be used as a functional polymer.

Among the vinylpyridine polymers shown in Table 2, which have an ability to adsorb pyrodiene, they also have an excellent ability to adsorb bacteria, so they are optimal as sterilization filters.

The medical filter of the present invention can be used without particular limitation for liquids injected into the body such as infusions and blood transfusions, but it can be particularly suitably used for injecting infusions.

The filter of the present invention can be particularly used for infusions such as nutrient solutions such as amino acids and glucose, water, electrolyte solutions such as lactated Ringer's solution, and plasma colloid fluids.

In particular, it can be suitably used in cases where nutrients are supplied over a long period of time only through infusions, such as high-calorie infusions consisting of high-concentration glucose, amino acid solutions, and fat emulsions.

When a high concentration of such different types of nutrients is contained, white turbidity may occur in the liquid, but the vinyl pyridine polymer filter of the present invention has an adsorption mechanism rather than a filtration mechanism, so the filter of the present invention can be easily used. No clogging occurs even after long-term use.

The medical infusion circuit of the present invention, as shown in the embodiment of FIG. The filter medium part is a circuit made of vinylpyridine polymer.

The infusion solution flows down from one side of the upper infusion tank 12 by gravity. The flow rate can be adjusted with a flow rate regulator 14. It can be confirmed that the drip tube 13 does not stop flowing down.

The infusion that has passed through the sterilization filter 11 filled with the vinylpyridine polymer of the present invention can be injected into a blood vessel through a catheter 18 connected with a connector 17.

The injection side pipe 15 from the liquid medicine tank 16 that is added continuously or intermittently in the middle of the infusion circuit is connected to the circuit in front of the medical filter 11 of the present invention, so that the medicine liquid that is added separately is connected to the circuit in front of the medical filter 11 of the present invention. It can also sterilize types.

[Example] The present invention will be explained in more detail with reference to Examples.

However, the present invention is not limited to the description of the examples.

Example 1 A sterilizing filter with a filling part having a diameter of 1.5 cm and a height of 4.0 cm was filled with 1.0 g of vinyl pyridine polymer (crosslinked copolymer of vinyl pyridine and styrene). It was incorporated into the circuit shown in Figure 2.

High calorie infusion containing 10% glucose, 10% amino acids, and 10% fat emulsion containing 10 Bacillus subtilis/I+
lfi and pyrodiene were added so as to contain 0.1 mg/mQ, and this was placed in the infusion tank of the circuit shown in Fig. 2 and allowed to flow at a flow rate of 7rd 1 minute for 1 hour. During this time, there was no clogging and flowed smoothly.

The first effluent, 5+++Q, was removed, and 5 mQ of the effluent was collected, which was examined under a microscope to measure the bacterial concentration. The bacterial concentration was 87 cells/mQ.

Next, a qualitative test for pyrodiene derived from microorganisms was conducted using the Limulus single test method, and a negative result was confirmed.

Comparative Example A filter with a pore size of 0.22 μm (filter 1.5×4.0 cm) was used in place of the filter of the example, and the same infusion as in the example was passed through and the same operation was performed.

Due to clogging, the liquid stopped flowing immediately after starting the flow.

Next, a test similar to that in the example was conducted using the same infusion solution from which the fat emulsion had been removed. Although there was no clogging, the qualitative test for pyrodiene was positive.

[Effects of the Invention] The medical filter of the present invention can be used without clogging even with infusions in which substances tend to precipitate, such as high-calorie infusions and drug-added infusions.

Moreover, the presence of nutrients in the infusion does not affect the pyrogen removal function, especially when using a polymer that also has a sterilizing function or mixing polymer particles with a sterilizing function.
Sterilization and pyrogen removal of high-calorie infusions can be suitably carried out.

When injected into the body by the medical filter circuit of the present invention, it is possible to not only achieve sterilization of infusion fluids and additive medicine solutions, but also to
It can also remove viruses and pyrogens that cannot be removed with conventional sterilizing filters. This has the great advantage of eliminating the risk of the patient developing a fever or contracting a disease.

[Brief explanation of the drawing]

FIG. 1 is a sectional view showing the structure of a medical filter according to an embodiment of the present invention, and FIG. 2 is a flow sheet diagram of an infusion injection circuit according to the present invention. The symbols in the figure are: 1; Column; 2; Vinylpyridine polymer particles; 3.4; Net; 5; Cock; 11; KII filter; 12; Infusion tank; 13; Drip tube; 14; Flow regulator; Injection tube, 16: Chemical liquid tank, 17: Connector 18: Catheter.

Claims (1)

[Scope of Claims] 1. A medical filter filled with polymer particles having a particle size of 5 to 1000 μm and having pyrogen adsorption ability as a filter medium. 2. The medical filter according to claim 1, wherein the pyrogen adsorption ability polymer particles are polymer particles containing a vinylpyridine structural unit. 3. A circuit consisting of an infusion tank, drip tube, flow rate regulator, sterilization filter, and catheters, which is filled with polymer particles with a particle size of 5 to 1000 μm and capable of adsorbing pyrogen as a filter material for the sterilization filter. A medical injection circuit featuring: 4. The medical injection circuit according to claim 3, wherein the pyrogen-adsorbing polymer particles are polymer particles containing vinylpyridine structural units.