JPH1024101A - Antibacterial humor trapping bag - Google Patents

Abstract

PROBLEM TO BE SOLVED: To obtain an antibacterial humor trapping bag which is made stable for a long time by housing a molded product comprising a biguanide compound and a thermoplastic resin into a humor trapping bag. SOLUTION: A molded product comprising a biguanide compound and a thermoplastic resin is housed into a humor trapping bag to make an antibacterial humor trapping bag. The molded product is formed by melting and kneading the biguanide compound and the thermoplastic resin. The humor trapping bag is also served as urine storage bag. The antibacterial humor trapping bag is made antibacterial stably for a long time. This enables restricting of the proliferation of bacteria for a long time within a discharge trapping bag in which is stored a discharge such as urine or blood discharged from a human body thereby inhibiting bacterial infection through the discharge.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an antibacterial body fluid collecting bag, and more particularly, to a bag for collecting body fluid such as urine and blood discharged from the human body. TECHNICAL FIELD The present invention relates to an antibacterial body fluid collection bag that suppresses the growth of bacteria in bodily fluids.

[0002]

2. Description of the Related Art In recent years, medical tubes and catheters have been placed in the body to discharge body fluids as a treatment for treating diseases of various organs. However, bacteria are collected in a container for collecting body fluids. There is a problem that they propagate and invade the body to cause infection. For example,
When the body fluid collection container is a flexible bag, there is a problem that body fluid in the bag flows back through a medical tube and a catheter due to external pressure, and bacteria enter the body to cause an infection. Was. In order to solve this, a check valve is provided on the collection container or tube to prevent the stored liquid from flowing into the body by closing the valve by the pressure when the stored body fluid flows backward. Proposed. For example, Japanese Patent Publication No. 56-5010
No. 35, Japanese Utility Model Application Laid-Open No. 57-107521, in which a check valve is provided in a urinary tract, Japanese Patent Application Laid-Open No. 52-139295, Japanese Utility Model Application Laid-Open No. 58-25105, Japanese Utility Model Application Laid-Open No.
No. 47738 and Japanese Utility Model Publication No. 53-14072 disclose a device in which a check valve is provided between a ureter tube and a urine storage bag.

However, in any of the above proposals,
There is a time lag between the start of backflow of the body fluid in the body fluid collection bag and the complete closure of the check valve, so it is not possible to completely prevent backflow of body fluid, and as a result, bacteria enter the body Cause. Japanese Patent Publication No. 1-55011 discloses that a three-way cock is improved to prevent bacteria floating in the air from entering a urine collection bag from a urine collection port. However, after the urine has passed through the flow path of the three-way cock, it is inevitable that even a small amount of urine remains in the flow path, and this can be a hotbed for bacterial propagation. This does not completely prevent urinary tract infection.

[0004] Japanese Patent Application Publication No. Sho 60-501041 discloses a storage in a pouch having an antimicrobial effect by urination. This is because the water vapor of the urine stored in the urination bag diffuses into the gas permeable pouch containing the agent that emits the antimicrobial gas, and the antimicrobial gas is generated by the reaction between the water vapor and the agent of the urine. It is generated and diffuses from the pouch into the urination bag, thereby preventing the growth of bacteria in urine. However, it is not possible to completely deny the possibility that urine in the urination bag is contaminated by microorganisms for some reason without waiting for the generation of antimicrobial gas, which may cause urinary tract infection. Also, in the method of directly injecting the gas generating agent into the urination bag, the effect is exhibited by dissolving the agent in the urine, but there is no effect once the urine in the bag is discharged, and the agent is dispensed each time the urine is discharged. Must be put in, which is troublesome and inconvenient. Tokuho 1-550
No. 24 discloses that a bactericide is contained in a resin constituting a medical device to kill microorganisms in contact with the resin to prevent the growth of microorganisms in the medical device. However, the disinfectant used here has a low melting point, a boiling point,
Since it has the property of evaporating when it is contained in a resin, it is difficult to make the content of the bactericide in the resin constituting the medical device constant, and there is a problem that the bactericidal effect is not constant.

[0005]

As described above, the conventional proposal prevents the body fluid in the collection bag from flowing back into the body,
Alternatively, although it is thought that bacteria do not easily enter the collection bag, it does not have the effect of efficiently and positively suppressing the growth of bacteria that have entered the bag for a long period of time. Therefore, a body fluid collection bag having antibacterial properties capable of actively suppressing the growth of bacteria and the like in the body fluid collection bag has been desired. The present invention
It is an object of the present invention to provide a body fluid collecting bag having stable antibacterial properties for a long period of time.

[0006]

Means for Solving the Problems The inventors of the present invention have conducted intensive studies to solve the above-mentioned problems, and as a result, by storing a molded body composed of a biguanide compound and a thermoplastic resin in a body fluid collecting bag for a long period of time. The present inventors have found that a body fluid collecting bag having stable antibacterial properties is obtained, and arrived at the present invention. That is,
The gist of the present invention is to provide an antibacterial bodily fluid collecting bag, characterized in that a molded body comprising a biguanide compound and a thermoplastic resin is housed in a bodily fluid collecting bag.

[0007]

BEST MODE FOR CARRYING OUT THE INVENTION Hereinafter, the present invention will be described in detail.

[0008] As the thermoplastic resin used in the present invention, any polymer compound may be used as long as it is thermoplastic. Also,
In order to exhibit persistent antibacterial properties, a hydrophobic polymer compound is preferably used.

Here, the hydrophobic polymer compound is a polymer compound having a water absorption capacity of 1.0% by weight or less in an atmosphere at a temperature of 20 ° C. and a relative humidity of 65%. Examples of the hydrophobic polymer compound include polymers or copolymers of diene monomers such as ethylene, propylene, butadiene, pentadiene, hexadiene, and heptadiene, styrene-butadiene-styrene, styrene-isoprene-styrene, and styrene- Examples thereof include styrene-based thermoplastic elastomers such as ethylenebutylene-styrene, ethylene-vinyl acetate copolymer, polyvinyl chloride, polyurethane, polyamide, and polyester.

The biguanide compound used in the present invention is a biguanide compound and salts thereof, and is specifically represented by the following general formula (1) or (2).

[0011]

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[0012]

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In the general formulas (1) and (2), R represents an alkyl group, aminoalkyl group, phenyl group, alkylphenyl group, halogenated phenyl group, hydroxyphenyl group, methoxyphenyl group, carboxylphenyl group, naphthyl group or A nitrile group, and R 'is hydrogen or an alkyl group. n is a positive integer, but a range of 2 to 10 is preferable. Preferable examples of such biguanide compounds include 1,6-di- (4-chlorophenylbiguanide).
Hexane, diaminohexyl biguanide, 1,6-di-
(4-aminohexyl biguanide) hexane and the like.

The biguanide compound is a basic compound, and when it is actually used, it is usually used as a salt. As the salt of the biguanide compound, a salt formed from the biguanide compound and an inorganic acid or an organic acid may be used. Examples of the inorganic or organic acid that forms a sparingly water-soluble salt with the biguanide compound include, for example, hydrochloric acid, hydrobromic acid, nitric acid, sulfuric acid, carbonic acid, bicarbonate, citric acid, phosphoric acid, boric acid, formic acid,
Acetic acid, oxalic acid, gluconic acid, benzoic acid, tartaric acid and the like can be mentioned. These biguanide compounds may be used alone or as a mixture of various salts.

A biguanide compound incorporated in a thermoplastic resin, particularly a sparingly water-soluble biguanide compound incorporated in a hydrophobic thermoplastic resin, is extremely difficult to elute, and the elution rate is hardly affected by ambient moisture. As compared with a molded article composed of another polymer material and an antibacterial agent, the molded article of the present invention can maintain stable antibacterial properties for a long period of time. Further, since the biguanide compound has a high decomposition temperature, it is stable even when heat is applied during molding of a molded body composed of the biguanide compound and the thermoplastic resin.

The molded article comprising the biguanide compound and the thermoplastic resin used in the present invention can be obtained by a known method. For example, a molded article having a predetermined shape can be obtained by melt-kneading a biguanide compound and a thermoplastic resin. Also, a dipping method in which a molded article molded into a predetermined shape using only a thermoplastic resin is immersed in a mixed solution of a thermoplastic resin and a biguanide compound, or a molded article molded into a predetermined shape using only a thermoplastic resin Can be obtained by, for example, an impregnation method in which the product is immersed in a solvent containing a biguanide compound.

Among the above molding methods, the method of melt-kneading the biguanide compound and the thermoplastic resin is a method in which heat is applied. However, a certain amount of the biguanide compound can be contained in the molded body, and the antibacterial effect is stabilized. Therefore, it is particularly preferable.

As a method of melting and kneading the biguanide compound and the thermoplastic resin, the biguanide compound and the thermoplastic resin may be melted and mixed together, or only the thermoplastic resin may be melted and mixed with the non-molten state. A biguanide compound may be mixed.

As a method of melting and mixing the biguanide compound and the thermoplastic resin together, the biguanide compound and the thermoplastic resin may be separately melted and then mixed, or the biguanide compound and the thermoplastic resin may be mixed. Thereafter, both may be melted.

In the case where both the biguanide compound and the thermoplastic resin are kneaded in a molten state, if the melting point of the thermoplastic resin is higher than the melting point of the biguanide compound, it is not necessary to raise the melting point of the thermoplastic resin. As a result, thermal deterioration of the thermoplastic resin due to high temperature can be prevented, and unnecessary heating can be avoided to perform more economical molding. Examples of such a combination of a thermoplastic resin and a biguanide compound include polyvinyl chloride and chlorhexidine hydrochloride, and polyurethane and chlorhexidine acetate.

When the melting point of the biguanide compound is higher than the melting point of the thermoplastic resin, only the thermoplastic resin is melted at a temperature lower than the melting point of the biguanide compound and higher than the melting point of the thermoplastic resin, and kneaded with the biguanide compound. Even so, the biguanide compound can be uniformly mixed in the thermoplastic resin.

When the biguanide compound and the thermoplastic resin are melted and mixed, an extrusion kneader or the like may be used.
As the extrusion kneader, a type in which a thermoplastic resin and a biguanide compound are continuously supplied and a melt-kneaded antibacterial material is continuously taken out is preferably used from the viewpoint of productivity. From the viewpoint of kneading properties, it is preferable to use a twin-screw kneading extruder. Furthermore, it is also possible to carry out molding simultaneously with an injection molding machine.

The amount of the biguanide compound contained in the molded article is preferably 0.01 to 30.0% by weight, more preferably 0.1 to 10.0% by weight. Content 0.0
If the amount is less than 1% by weight, sufficient antibacterial activity may not be exhibited. If the amount exceeds 30.0% by weight, the strength of the molded body may be reduced. When removing, it may be removed together with body fluids.

The shape of the molded product obtained by kneading and molding the biguanide compound and the thermoplastic resin may be a yarn, a sheet, a film,
Examples thereof include a plate shape, a disk shape, a nonwoven fabric, a sponge shape, and a knitted fabric. The size, thickness, surface area, and volume of the molded body are not particularly limited, but are large enough to be easily stored in the body fluid collection bag, and large enough not to reduce the amount of stored body fluid. Anything can be used.

The body fluid collection bag used in the present invention is a bag for collecting body fluid discharged from the human body, such as a urine storage bag, an ostomy bag, a blood bag, and other containers for temporarily storing drainage. That is. Usually, two plastic sheets are piled up and their peripheral edges are fused together to form a bag. Part of the plastic sheet is an inlet for bodily fluids and, if necessary, an outlet for stored liquid. These openings may be provided with openable and closable clamps, valves, and the like. In order to prevent the invasion of bacteria from the outside, the body fluid storage bag used in the present invention is desirably sealed. When a vent is required for the collecting bag, a closed collecting bag provided with a sterilization filter at the vent is preferable because it can prevent bacteria from entering.

The antibacterial bodily fluid collecting bag of the present invention is obtained by storing a molded body made of a biguanide compound and a thermoplastic resin in the bodily fluid collecting bag so as to be in contact with the bodily fluid collected in the bodily fluid collecting bag. Good.

[0027]

Next, the present invention will be described specifically with reference to examples. Example 1 After kneading a soft polyvinyl chloride resin (Esmedica, manufactured by Sekisui Chemical Co., Ltd.) and chlorhexidine acetate (Aldrich Chemical Co., Ltd., solubility: 0.01 g), the final concentration after kneading was about 1.0% by weight. In addition, kneading extruder PCM-30
The mixture was kneaded at 190 ° C. with a kneading temperature of 190 ° C. (manufactured by Ikegai Iron Works Co., Ltd.) to obtain an antibacterial material for molding in which chlorhexidine was uniformly dispersed. Using the obtained antibacterial material for molding, by injection molding into a plate having a thickness of 3 mm using an injection molding machine J-100 (manufactured by Japan Steel Works, Ltd.),
A molded article was obtained.

The antibacterial activity of the surface of the obtained plate-like molded product was measured by the following method. 1 cm ×
Cut into 1 cm samples to be placed in vials, containing about 10 ⁷ cells / ml Staphylococcus aureus (ATCC6538P) on the surface;
Brain Heart Infusion Medium
Infusion broth) [Becton Dickinson (Bect
on Dickinson Overseas Inc.)].
Further, another sample plate was placed on the sample plate inoculated with the bacterial solution, and the bacterial solution was sandwiched between the two samples.
The cells were cultured at 37 ° C. for an hour. The number of bacteria after 4 hours of culture was counted by the colony counting method. For comparison, a plate-like molded product was injection-molded with S-Medica containing no antibacterial agent, subjected to the same test method as above, cultured for 4 hours as a control, and the number of bacteria after the culture was counted. Table 1 shows the results of counting the number of bacteria by each sample. Samples without antimicrobial showed increased bacterial counts. On the other hand, in the sample containing chlorhexidine acetate, a remarkable decrease in the number of bacteria was observed, and it was confirmed that the embedded chlorhexidine acetate effectively acted on bacteria on the surface.

[0029]

[Table 1]

Next, in order to confirm the durability of the antibacterial activity,
Among the samples used in the above measurement, a sample containing chlorhexidine acetate was disinfected with a 70% aqueous ethanol solution, and a surfactant Tween80 (a nonionic surfactant obtained by adding ethylene oxide to a sorbitan fatty acid ester manufactured by Becton Dickinson) was added. Agent) was thoroughly stirred and washed in a 0.1% saline solution, and then subjected to the above-described culture experiment again to measure the increase and decrease in the number of bacteria. Here, take the logarithmic value of the number of bacteria after 4 hours of culture, determine the difference from the logarithmic value of the number of initial bacteria,
The difference between the control of this value and the sample was determined as an increase / decrease value difference. That is, the difference in increase / decrease value can be treated as a parameter indicating that the larger the numerical value, the higher the antibacterial activity of the test material. FIG. 1 shows the transition of the increase / decrease value difference when washing and re-measurement were repeated up to six times. From these results, it was suggested that the molded article maintained sufficient antibacterial activity even at the time of the sixth measurement in the washing test under severe conditions, and that the antibacterial property could be maintained for a sufficient period under actual use conditions. The plate-shaped molded article having the above antibacterial activity, urine storage bag, ostomy bag,
The antibacterial body fluid collection bag of the present invention was prepared by storing the bag in a blood bag.

Example 2 Ethylene-vinyl acetate copolymer [Evaflex (EV)
AFLEX) P-3307, manufactured by DuPont-Mitsui Polychemicals Co., Ltd.] 40 g and 2 g of chlorhexidine hydrochloride are kneaded at 120 ° C. by a twin-screw kneader (manufactured by Toyo Seiki Seisaku-sho, Ltd.), and the antibacterial agent is homogenized. To obtain an antimicrobial material dispersed. Pressing machine (Hayashi Seisakusho) with antibacterial material obtained
To obtain a sheet-like molded body. When obtained was measured antibacterial activity in the same manner as in Example 1 by using the sheet-form body, to several 10 ⁵ initial bacteria, after 4 h of culture were not detected bacteria with an antimicrobial agent-containing sheet . However, in the sheet containing no antibacterial agent, the bacterium is 8 × 10 ⁶
Had increased to pieces. Next, the antibacterial humor collection bag of the present invention was produced by storing the above-mentioned plate-shaped molded product having antibacterial activity in a urine storage bag, an ostomy bag, and a blood bag.

Example 3 Ethylene-vinyl acetate copolymer [EVFLEX (EV)
AFLEX) P-3307, manufactured by DuPont-Mitsui Polychemicals Co., Ltd.] 40 g and 1 g each of chlorhexidine hydrochloride and chlorhexidine gluconate were melted at 120 ° C. by a twin-screw kneader (manufactured by Toyo Seiki Seisakusho). The mixture was kneaded to obtain an antibacterial material in which the antibacterial agent was uniformly dispersed. The obtained antibacterial material was pressed by a press machine (manufactured by Hayashi Seisakusho) to obtain a sheet-like molded body. When obtained was measured antibacterial activity in the same manner as in Example 1 by using the sheet-form body, to several 10 ⁵ initial bacteria, after 4 h of culture were not detected bacteria with an antimicrobial agent-containing sheet . However, in the sheet containing no antibacterial agent, the number of bacteria increased to 2 × 10 ⁶ . Next, the antibacterial humor collection bag of the present invention was produced by storing the above-mentioned plate-shaped molded product having antibacterial activity in a urine storage bag, an ostomy bag, and a blood bag.

Example 4 Ethylene-vinyl acetate copolymer [EVFLEX (EV)
AFLEX) P-3307, manufactured by DuPont-Mitsui Polychemicals Co., Ltd.] 40 g and 2 g of chlorhexidine hydrochloride are kneaded at 140 ° C. by a twin-screw kneader (manufactured by Toyo Seiki Seisaku-sho, Ltd.), and the antibacterial agent is homogenized. To obtain an antimicrobial material dispersed. The obtained antibacterial material is 2 cm in diameter using an injection molding machine.
Into a disk shape. When obtained by using the disc-shaped molded product was measured antibacterial activity in the same manner as in Example 1, with respect to several 10 ⁵ initial bacteria, the discs after 4 hours incubation does not contain an antimicrobial agent, bacteria Was increased to 5 × 10 ⁶ , but the number of bacteria was reduced to 9 × 10 ^{3 on the} disc containing the antibacterial agent.

Next, one disk-shaped molded article having the above-mentioned antibacterial activity was put in a bag made of polyvinyl chloride containing 200 ml of artificial urine, and then 2 Staphylococcus aureus (ATCC6538P) was added. × 10 ⁷ were inserted. After shaking at 37 ° C. for 4 hours, the concentration of the bacterial solution was measured. As a result, the initial concentration was 4.3 × 10 ³ cells / ml against 1 × 10 ⁵ cells / ml.
Pcs / ml.

Example 5 Styrene-ethylenebutylene-styrene copolymer (MJ
4300, manufactured by Mitsubishi Chemical Corporation) and 180 g of chlorhexidine hydrochloride 2 g were mixed by a twin-screw kneader (manufactured by Toyo Seiki Seisakusho).
Knead in a state where both are melted at ℃, extruded into a thread,
An antibacterial material having a thickness of 1 mm in which the antibacterial agent was uniformly dispersed was obtained.
The obtained filamentous antibacterial material was knitted to obtain a knitted fabric. The antibacterial activity of this knitted molded article was measured in the same manner as in Example 1. As a result, the number of bacteria was 4 in the case of a knitted fabric containing no antibacterial agent after 4 hours of cultivation for 10 ⁵ cells. ×
The number was reduced to 10 ⁴ but the number of bacteria was 1 in knitted fabric containing antibacterial agent.
The number was reduced to × 10 ² , confirming that the knitted fabric containing the antibacterial agent of the present invention more effectively acted on bacteria.
Next, the antibacterial body fluid collection bag of the present invention was produced by storing the knitted fabric having the antibacterial activity in a urine storage bag, an ostomy bag, and a blood bag.

[0036]

The antibacterial bodily fluid collection bag of the present invention has a stable antibacterial property for a long period of time, and can be used in a drainage collection bag storing urine, blood, etc. drainage discharged from the human body. Can be suppressed for a long period of time, and bacterial infection via drainage can be suppressed.

[Brief description of the drawings]

FIG. 1 is a graph showing the persistence of antibacterial activity of a molded article used for an antibacterial body fluid collecting bag of the present invention.

 ────────────────────────────────────────────────── ─── Continuing on the front page (72) Inventor Yuki Yashitoshi 4-3-1, Kutaro-cho, Chuo-ku, Osaka-shi, Osaka

Claims (3)

[Claims] 1. An antibacterial bodily fluid collecting bag, wherein a molded body comprising a biguanide compound and a thermoplastic resin is housed in a bodily fluid collecting bag. 2. A molded article formed by melting and kneading a biguanide compound and a thermoplastic resin.
The antibacterial body fluid collection bag according to the above. 3. The antibacterial body fluid collection bag according to claim 1, wherein the body fluid collection bag is a urine storage bag.