JP3528723B2 - Infusion filter - Google Patents

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a filter for removing foreign substances which are contained in a drug solution and which are unfavorable to the living body when the drug solution is administered to a patient.

[0002]

2. Description of the Related Art In medical facilities, infusion is widely performed for the purpose of nutritional supplementation, balance adjustment of electrolytes in the body, hydration, treatment and the like. At that time, as foreign substances that may be mixed in the chemical liquid, for example, foreign substances that have been mixed in the chemical liquid from the beginning, cutting dust and fine particles of glass dust mixed when the bottle needle is pierced into the rubber stopper of the infusion container. , There are bacteria and the like that enter when preparing an infusion set or during mixed injection, but these foreign substances harmful to the living body must be removed so as not to be administered to patients. Therefore, an infusion filter is often attached to the infusion set for the purpose of removing the foreign matter.

Infusion filters include flat membrane filters and hollow fiber filters, each of which has its own characteristics. In recent years, however, fine particles can be almost completely removed, and a large membrane area can be secured with a small filling amount. For this reason, hollow fiber type infusion filters have been attracting attention.

[0004]

DISCLOSURE OF THE INVENTION Problems to be Solved by the Invention In an infusion filter, the following three items are desirable requirements. That is, (1) the filtration flow rate is large, (2) the filling amount (also referred to as the priming amount) is small, and (3) the membrane area of the filter is small. The fact that the filtration flow rate is large means that the infusion filter has good permeability and the filtration treatment capacity per unit time is excellent. The small filling amount means that the dead volume (retention amount) staying in the housing of the infusion filter is small, which is advantageous especially when a small amount of drug solution is to be administered or a specific drug solution is desired to be rapidly injected. In addition, the amount of liquid remaining in the infusion filter at the end of infusion can be reduced. The small filter membrane area is advantageous in terms of manufacturing cost because the material cost can be reduced. Further, by reducing the membrane area, there are advantages that the filling amount can be reduced and the drug adsorption amount on the filter can be reduced.

However, the above requirements (1), (2) and (3) are contradictory, and it is not easy to manufacture an infusion filter having excellent performance from these viewpoints. Moreover, it has been more difficult to supply such an infusion filter at a low cost. For example, considering an infusion filter having a hollow fiber membrane, it is necessary to increase the membrane area of the filter hollow fiber in order to increase the filtration flow rate of the entire infusion filter. In order to increase the membrane area of the hollow fiber, a larger amount of hollow fiber membrane is required, and the filter housing must be upsized in order to fill the large amount of hollow fiber. As a result, the filling amount of the infusion filter becomes large. On the contrary, in order to reduce the membrane area and filling amount of the infusion filter, the filtration flow rate must be sacrificed.

As described above, the above-mentioned three requirements are contradictory matters, and thus it has been difficult to obtain an infusion filter having excellent performance at low cost.

In order to solve the above-mentioned conventional problems, it is an object of the present invention to provide an infusion filter having excellent performance at low cost by setting the filling rate of the porous hollow fiber bundle in a specific range.

[0008]

In order to achieve the above object, an infusion filter of the present invention comprises a housing having a liquid inlet and a liquid outlet, and the inside of the housing is potting material on the outside of both ends. An infusion filter, which is filled with a fixed and held porous hollow fiber bundle and which filters a liquid by the porous hollow fibers existing between the liquid inflow port and the liquid outflow port, wherein The filling rate of the hollow fiber bundle to be filled is in the range of 15 to 40%, and the porosity is
The effective length of the substantially filterable portion of the hollow fiber is 2.0 to
4.5 cm range, filled with liquid to fill the housing
The filling amount is 3.0 ml (ml) or less .

In the above infusion filter, the filling rate is preferably in the range of 15 to 35%.

In the above infusion filter, the effective length of the substantially filterable portion of the porous hollow fiber is 2.5.
The range is preferably 3.5 cm to 3.5 cm, and particularly 2.5 to 3.
A range of 0 cm is preferred.

In the above-mentioned infusion filter, the hollow fibers constituting the hollow fiber bundle have an average inner diameter of 100 to 500 μm.
and the average thickness of the hollow fibers is 20 to 200.
It is preferably in the range of μm. More preferably,
The average inner diameter of the hollow fibers of the hollow fiber bundle is 200 to 400 μm.
And the average thickness of the hollow fibers is 50 to 150 μm.
The range is m.

In the above infusion filter, the hollow fiber is any one selected from polysulfone, polyether sulfone, polypropylene, polyethylene, cellulose, cellulose derivative, polyacrylonitrile, ethylene-vinyl acetate copolymer and ethylene vinyl alcohol. It is preferable to use the above material. More preferably,
The hollow fiber is a hydrophilic material. This is because it is easily compatible with infusion solutions.

In the above infusion filter, it is preferable that the number of hollow fibers filled in the housing is in the range of 10 to 50. More preferably, the number of hollow fibers filled in the housing is in the range of 10 to 30.

In the above-mentioned infusion filter, the filling amount of the liquid filled in the housing is preferably 1.0.
~ 2.0 ml.

In the above infusion filter, the housing has a cylindrical shape, and the length of the cylinder is 2.0 to
The range is 5.0 cm, and the inner diameter is preferably 0.3 to 2.0 cm. More preferably, the length of the cylinder is in the range of 2.0 to 3.0 cm and the inner diameter is in the range of 0.5 to 1.5 cm.

Further, in the above infusion filter, the filtration flow rate filtered through the filtration section is 15 to 50 ml.
It is preferably in the range of / min.

Further, in the above-mentioned infusion filter, it is preferable that the total effective filtration area of the filtration section is in the range of 10 to 40 cm ² . More preferably, the total effective filtration area of the filtration part is in the range of 10 to 25 cm ² .

In the above infusion filter, it is preferable that the hollow fibers forming the hollow fiber bundle have substantially the same length.

[0019]

BEST MODE FOR CARRYING OUT THE INVENTION In the present invention, the above three requirements are satisfied.
The above problems have been solved by appropriately balancing (1) improvement of filtration flow rate, (2) reduction of filling amount, and (3) reduction of membrane area. More specifically, by regulating the filling rate (hereinafter, also referred to as the filling rate) of the hollow fibers to be filled in the infusion filter within a predetermined range, it is possible to improve the filtration flow rate while suppressing the prescribed filling amount. It was Further, in the hollow fiber filled in the infusion filter, the effective flow length of the hollow fiber, which is defined as the axial length of the region (portion) that can be filtered substantially, is defined within a predetermined range to improve the filtration flow rate. And the film area could be reduced. Furthermore, by defining the effective length of the hollow fiber and the filling rate in the respective predetermined ranges, it is possible to provide an infusion filter having more excellent performance at low cost.

Especially when the effective length is 4.5 cm or less,
Filtration flow rate: 23 ml / min or more, filling amount: 1.5 ml
When the following conditions are satisfied, the filling rate of the hollow fiber is 15 to 40.
% Is preferable, 15-35% is more preferable, 20-3
0% is more preferable.

The present invention can employ various embodiments described below. (1) The hollow fiber bundle has an average inner diameter of 100 to 500.
The average thickness of the hollow fibers is 20 to 200 μm. (2) The hollow fiber is made of polysulfone (PS), polyether sulfone (PES), polypropylene (PP), polyethylene (PE), cellulose, cellulose derivative, polyacrylonitrile (PAN), ethylene-vinyl acetate copolymer (EVA). ), Ethylene vinyl alcohol (EVA
L) selected from synthetic resins. (3) The effective length is 2.0 to 4.5 cm, preferably 2.
It is 5 to 3.5 cm, and more preferably 2.5 to 3.0 cm. (4) The number of hollow fibers filled in the housing is 10
It is 50. (5) The amount of liquid filled in the housing is 3.0 m
It is 1 or less. (6) The housing has a cylindrical shape, the length of the cylinder is 2.0 to 5.0 cm, and the inner diameter is 0.3 to 2.0 cm.
Is. (7) The filtration flow rate filtered through the filtration unit is 15 to 5
It is 0 ml / min. (8) The total effective filtration area of the filtration section is 10 to 40 cm ² .

[0022]

EXAMPLES The effects on the performance and manufacturing cost of the infusion filter of the present invention will be described more specifically below based on examples.

In the following examples, the filling rate of hollow fibers was
It was determined by the following formula (Equation 1). That is, what is meant by the following formula (Equation 1) indicates the ratio of the cross-sectional area of all the hollow fibers to the cross-sectional area of the housing, for example, in the cross section of the boundary portion between the hollow fibers and the potting material.

[0024]

[Equation 1]

[0025]

Example 1 a. Hollow fiber material (1) Hollow fiber: Polyethersulfone porous hollow fiber (MEMBRANA (formerly AKZO)) inner diameter: 300 μm, wall thickness: 100 μm, average pore diameter: 0.2 μm, maximum pore diameter:
0.6 μm, axial length 6.0 cm, 7.0 cm,
8.0 cm, 9.0 cm, 10.0 cm, 11.0 cm
Both ends of each were fixed with polyurethane resin by potting. A hollow fiber effective length is an axial length of a portion that can be substantially filtered, and the effective length is 2.0 cm,
2.5cm, 3.0cm, 3.5cm, 4.0cm,
4.5 cm of each was prepared. (2) Housing: A transparent cylindrical shape made of polymethylmethacrylate, having an inner diameter of 0.5 cm and a length of 0.5 mm each of the above-mentioned effective lengths. The outline is shown in FIG. In FIG. 3, 1 is an infusion filter according to an embodiment of the present invention, 2 is a liquid inlet for a liquid to be filtered, 3 is an air vent, 4 is a hollow fiber for filtering a liquid, and 5 is both ends of the hollow fiber 4. A tube seal (potting material) for sealing the outside, 6 is a liquid outlet for taking out filtered liquid, and 7 is a housing. A is the length of the housing 7, and B is a filterable region of the hollow fiber membrane (a portion serving as a reference for the effective length).

Here, since the hollow fiber is bent at the inflection part at the top, the flow of the liquid is blocked, and even if the inflection part is in communication, the liquid is supplied from both ends of the hollow fiber. Since it flows in, the flow passage is one-way as shown in FIG. 3B.

The liquid to be filtered is supplied from the liquid inflow port 2 into the housing 7, is filtered and purified when passing through the hollow fiber 4, enters the inside of the hollow fiber 4, and the potting material 5
Passing through the inside of the hollow fiber 4 existing in the above, and taken out from the end of the hollow fiber to the liquid outlet. The filtered material that cannot pass through the hollow fiber 4 remains inside the housing 7. (3) Infusion set equipped with an infusion filter: JMS infusion set 216D. (4) Chemical solution: Aminotripa II ("Aminotripa II") (manufactured by Otsuka Pharmaceutical Co., Ltd.) b. Method (1) Using the infusion set equipped with infusion filters having different effective lengths, the above drug solution was flown at a drop of 90 cm. For the above-mentioned drop of 90 cm, the practical use condition in a hospital was adopted. (2) The area of the hollow fiber membrane of each effective length was calculated, and the flux was measured from the filtration flow rate when the solution was poured by the above method. Table 1 shows the measurement conditions and the results.

[0028]

[Table 1]

(3) Table 2 shows the filter structure for satisfying the target filtration flow rate of 23 ml / min calculated from the flux of Table 1.

[0030]

[Table 2]

(4) Based on Table 2, the relationship between the effective length of the hollow fiber, the flux and the cost was plotted in the graph of FIG. The horizontal axis is the effective length of the hollow fiber, the vertical axis is the flux that is the basis of the filtration flow rate, and the cost per hollow fiber is the cost of the infusion filter that satisfies the target filtration flow rate (23 ml / min). The relationship between the effective length of the hollow fiber, the flux and the cost was investigated. The unit of flux is ml / min
cm ^2, and filtration flow rate is expressed by the product of the effective membrane area of the flux and the hollow fiber. The unit of cost is yen / book. In the range measured from this figure, the shorter the hollow fiber length, that is, the effective length of the hollow fiber, the larger the flux and the easier the liquid to flow. Therefore, in this graph where the filtration flow rate is constant, as the flux increases, the membrane area decreases.
Therefore, as the effective length of the hollow fiber becomes shorter, the area of the hollow fiber membrane for achieving the specified filtration flow rate can be reduced.

As a result, the cost of the hollow fiber is reduced. Actually, in the graph of FIG. 1 above, 4.5 to 2.5c
In the range of m, the cost per hollow fiber decreases as the effective length of the hollow fiber becomes shorter. But,
In the range of 2.5 to 2.0 cm, on the contrary, the effective length is shortened and the cost is increased. This is probably due to an increase in the non-filtering surface of the hollow fiber relative to the effective filtering surface due to the shortening of the effective length. In the hollow fiber infusion filter, both ends of the hollow fiber membrane are fixed by potting materials, but the hollow fiber portions fixed by this potting material are non-filtration surfaces that cannot filter the liquid. When the length of the hollow fiber is shortened, it is presumed that the ratio of the non-filtration surface to the whole hollow fiber is increased, and as a result, the cost is increased. Therefore, in order to obtain an infusion filter having better performance than the above results, a hollow fiber having an effective length of 2.0 to 4.5 cm can be practically used, but an effective length of 2.5 to Hollow fibers having a length of 3.5 cm are preferred, and hollow fibers having an effective length of 2.5 to 3.0 cm are more preferred.

[0033]

Example 2 a. Material of Hollow Fiber Using the hollow fiber of Example 1, the effective length of the hollow fiber is 4.5c.
The filling rate (volume%) of the hollow fiber fixed to m and filled in a housing having an inner diameter of 5.0 mm is 10%, 20%, 30%, 4
The same thing as Example 1 was used except having changed into 0% and 50%. b. Method (1) Using the infusion set equipped with infusion filters having different filling rates, the above-mentioned drug solution was flown at a drop of 90 cm. (2) The filtration flow rate of the infusion filter with each filling rate was measured and the flux was calculated. (3) Target filtration flow rate of 23 ml calculated from the flux
A filter structure for satisfying / min was determined, and the relationship between the filling rate of the hollow fiber, the flux, and the filling amount was plotted on a graph (Fig. 2).

FIG. 2 is a graph showing the data obtained by infusion using a hollow fiber filter having a constant effective length and a different filling rate. The horizontal axis shows the hollow fiber filling rate (%) in the housing, and the vertical axis shows the flux that is the basis of the filtration flow rate and the filling volume of the infusion filter. The infusion filter that satisfies the target filtration flow rate (23 ml / min) is shown. The relationship between the filling rate and the flux and filling amount was investigated. The unit of the flux is the same as the above, and the unit of the filling amount is ml. In the range measured from this figure, the flux is improved as the filling rate is lowered, but the filling amount for achieving the target filtration flow rate becomes large. When the filling rate is lowered,
The reason why the flux is improved is that the smaller the filling rate is, the more the hollow fibers are spaced apart from each other, and the interference due to the overlap is reduced, so that the flux is increased. Further, when the same amount of hollow fibers is filled to achieve the target filtration flow rate, the filling amount (the volume of the housing) is increased by decreasing the filling rate. When the length of the hollow fiber is constant in this way, a decrease in the filling rate has an effect that is contrary to the performance of the infusion filter, such as an improvement in the flux and an increase in the filling rate. This can be done by determining the maximum allowable value or minimum allowable value of the items (flux, filling amount). For example, if the allowable filling amount in the graph of FIG. 2 is set to 1.5 ml or less, the filling ratio that gives a filling amount less than this is 20 to 50%, and when trying to obtain the maximum flux in that range, the filling ratio becomes 20%
Becomes As described above, the filling rate of the hollow fibers is selected within a suitable range depending on the value of the permissible flux or filling amount, but is preferably 15 to 40%, more preferably 15 to 35%, and further preferably 20 to 30%. preferable.

[0035]

Example 3 The same experiment as in Example 2 was conducted except that the effective length of the hollow fiber was changed to 2.5 cm.

In Table 3 below, the effective length of the hollow fiber is 2.5c.
The results of the filling rate and the flux in the case of m are shown.

[0037]

[Table 3]

The results are summarized in FIG. As is clear from Table 3 and FIG. 4, the filling rate of the hollow fibers was preferably 15 to 40%.

As described above, the hollow fiber type infusion filter of the embodiment of the present invention has the following effects. (1) A large filtration flow rate can be obtained. Therefore, the amount of filtration per unit time (minute) is large, and the infusion can be performed with a small drop pressure. (2) Since the filling amount is small, the retention amount is small. As a result, it is possible to solve the problems such as the trace amount of the liquid medicine remaining and the drug effect lag time in the immediate-effect medicine. (3) The filter membrane area can be reduced. As a result, the manufacturing cost of the infusion filter can be reduced and the infusion filter can be provided at low cost.

[0040]

INDUSTRIAL APPLICABILITY As described above, according to the present invention, by setting the filling rate of the porous hollow fiber bundle in the range of 15 to 40%, the infusion filter has a large filtration capacity, excellent performance, and low cost. Can be

[Brief description of drawings]

FIG. 1 is an infusion filter of Example 1 of the present invention,
The graph which shows the influence which hollow fiber effective length has on flux or cost.

FIG. 2 is a graph showing the influence of the filling rate on the flux or the filling amount.

FIG. 3 is a schematic view showing an embodiment of the infusion filter of the present invention.

FIG. 4 shows an effective length of the hollow fiber of Example 3 of the present invention of 2.5c.
The graph which shows the result of the filling rate and the flux in case of m.

[Explanation of symbols]

1 Infusion Filter 2 Liquid Inlet 3 Air Vent 4 Hollow Fiber 5 Tube Seal (Potting Material) 6 Liquid Outlet 7 Housing A Housing Length B Hollow Fiber Membrane Filterable Area (Reference of Effective Length)

─────────────────────────────────────────────────── ─── Continuation of the front page (51) Int.Cl. ⁷ Identification code FI B01D 71/12 B01D 71/26 71/26 71/38 71/38 71/42 71/42 71/68 71/68 A61M 5 / 16 334T (56) Reference JP-A-10-151198 (JP, A) JP-A-5-42220 (JP, A) JP-A-5-42207 (JP, A) JP-A-10-80477 (JP, A) ) JP-A-10-340 (JP, A) JP-A-9-276408 (JP, A) JP-A-7-256285 (JP, A) JP-A-2-21871 (JP, A) JP-A-1- 201006 (JP, A) JP-A-1-121056 (JP, A) JP-A-1-317450 (JP, A) Actual development 4-126556 (JP, U) (58) Fields investigated (Int.Cl. ⁷ , DB name) A61M 5/165 A61M 1/18 500 B01D 63/02 B01D 69/08

Claims (14)

(57) [Claims] 1. A housing comprising a liquid inlet and a liquid outlet, wherein the housing is filled with a porous hollow fiber bundle whose outer ends are fixedly held by potting materials. An infusion filter for filtering a liquid by the porous hollow fiber existing between an inlet and the liquid outlet, wherein a filling rate of a hollow fiber bundle filled in the housing is 15 to
40% range , effective length of the substantially filterable portion of the porous hollow fiber
Is in the range of 2.0 to 4.5 cm, and the filling amount of the liquid filled in the housing is 3.0 milliliters.
An infusion filter characterized in that it is not more than a bottle (ml) . 2. The infusion filter according to claim 1, wherein the filling rate is in the range of 15 to 35%. 3. The hollow fiber has an effective length of 2.5 to 3.5 c.
The infusion filter according to claim 1 , which is in a range of m. 4. The hollow fiber has an effective length of 2.5 to 3.0 c.
The infusion filter according to claim 3 , which is in a range of m. 5. The infusion filter according to claim 1, wherein the hollow fibers forming the hollow fiber bundle have an average inner diameter in the range of 100 to 500 μm, and an average wall thickness of the hollow fibers in the range of 20 to 200 μm. 6. The average inner diameter of the hollow fibers of the hollow fiber bundle is 20.
The infusion filter according to claim 5 , wherein the average thickness of the hollow fibers is in the range of 0 to 400 µm, and the average thickness of the hollow fibers is in the range of 50 to 150 µm. 7. The hollow fiber is made of any material selected from polysulfone, polyether sulfone, polypropylene, polyethylene, cellulose, cellulose derivatives, polyacrylonitrile, ethylene-vinyl acetate copolymer and ethylene vinyl alcohol. The infusion filter according to Item 1. 8. The infusion filter according to claim 1, wherein the number of hollow fibers filled in the housing is in the range of 10 to 50. 9. The infusion filter according to claim 8 , wherein the number of hollow fibers filled in the housing is in the range of 10 to 30. 10. The infusion filter according to claim 1 , wherein the filling amount of the liquid filled in the housing is 1.0 to 2.0 ml. 11. The housing according to claim 1, wherein the housing has a cylindrical shape, the length of the cylinder is in the range of 2.0 to 5.0 cm, and the inner diameter is in the range of 0.3 to 2.0 cm. Infusion filter. 12. The infusion filter according to claim 1, wherein a flow rate of filtration through the filtration section is in the range of 15 to 50 ml / min. 13. The total effective filtration area of the filtration section is 10 to 10.
The infusion filter according to claim 1, which is in a range of 40 cm ² . 14. The infusion filter according to claim 1, wherein the hollow fibers constituting the hollow fiber bundle have substantially the same length.