JPH01136662A - Preparation of antibacterial urethral catheter - Google Patents

Abstract

PURPOSE:To provide a urethral catheter having continued antibacterial activity itself by obtaining latex composition with high stability by combining highly water soluble protein silver to natural or synthetic gum latex. CONSTITUTION:A urethral catheter made of natural gum is usually prepared from natural gum latex by soaking moulding method. Therefore, by preparing specially natural gum latex compositions combined with protein silver as a coating solution, catheters can be manufactured by the same method as used conventionally. Protein silver may be applied evenly to whole layer of a catheter. However, taking into consideration manufacturing cost, it is preferable to apply it only to the inner and outer surfaces. To avoid unnecessary irritation to the urethral mucosa, it is preferable to apply protein silver only in the more distal part than the site of a balloon which is retained in the urinary bladder.

Description

DETAILED DESCRIPTION OF THE INVENTION (Field of Industrial Application) The present invention relates to a method for manufacturing a urinary catheter, and more particularly, to a method for manufacturing a urinary catheter having antibacterial properties.

(Prior technology) Urinary catheters have become an indispensable tool in modern medical technology, and are used to temporarily secure the urinary tract for anatomical or physiological urinary disorders, and to treat urinary problems such as the urethra, prostate, and other surrounding areas. It is widely used to facilitate healing after surgical procedures on tissues of the body, and to secure the urinary tract in comatose and incontinent patients. However, if it is mismanaged unfortunately.

Furthermore, even with the utmost care, it is known that harm can be caused to the patients who should be cared for, as shown below. That is, it is known that bacteria from the outside world frequently cause urinary tract infections through the inside and outside of the lumen of the catheter.

By the way, in order to prevent urinary tract infections associated with catheter placement, conventional chemotherapy using antibiotics has been relied upon, but easy chemotherapy can cause new resistant bacteria to develop even after the infecting bacteria have been eradicated. It has been pointed out that it is actually dangerous, as it can lead to bacterial infection. Therefore, it is now believed that chemotherapy should be used only when necessary, such as when fever is caused by pyelonephritis.

On the other hand, in recent years, closed urinary catheter systems have become popular in order to prevent infection at the site where the catheter is placed, and have been found to be more effective in preventing urinary tract infections than conventional open systems. However, when compared to open urinary drainage systems, closed urinary drainage systems are effective in preventing retrograde infection through the intraductal route from the urine collection bag, but they are less susceptible to contamination due to attachment and detachment of the connection between the catheter and the urinary tube. It is known to be ineffective against extraluminal infections between the outer circumference of the catheter and the urethral mucosa. Therefore 2 e.g.

Currently, cumulative infections of around 40% are still observed in the group of patients not receiving antibiotics even after 5 days of indwelling in the body.

For this reason, recently, in order to fundamentally prevent bacterial infection at the site where the urinary catheter is placed, the urinary catheter itself has been
A type with antibacterial properties is strongly desired.

Conventionally, the most effective method for imparting sustained antibacterial activity to medical devices has been to disperse antibacterial agents so that a certain concentration or higher of the antibacterial agent is retained in or on the surface of the substrate during the course of its use. A so-called matrix device is considered as a system.

On the other hand, heavy metals such as gold, silver, copper, and zinc, as well as their metal compounds, are known to have strong bactericidal effects against microorganisms such as bacteria and fungi at extremely small concentrations in the form of metal ions. , is called oligodynamism. 'From the above-mentioned viewpoint, by utilizing the oligodynamics of the above metals, especially silver compounds,
Tools have been proposed in which a metal body is adhered to a base material, or a tool in which a metal is dispersed or blended in the base material.

For example, in Japanese Patent Application Laid-Open No. 52-62996.

a metal body having oligodynamics on the surface of a flexible tube;
Alternatively, a catheter covered with a ring, net, etc. made of a metal body has been proposed. However, the operation of attaching a metal body to the surface of a molded catheter is extremely troublesome and complicated, and the production efficiency in actual manufacturing sites is low.

Also, in JP-A-59-218517.

The antimicrobial metal compound is ground into particles within 30 microns and then dispersed in a suspension capable of forming a catheter.

A method of curing to form a catheter with antimicrobial activity is described. However, 3 metal compounds
Prevents the pulverization process into particles with a size of 0μ or less and the re-agglomeration of the pulverized metal compound particles.

In order to maintain a stable particle state, it is necessary to add a so-called surfactant, which increases production costs.

In general, silver compounds and silver salts have low solubility in water, so when they are mixed into latex in a solution state, the silver concentration in the base material is very low. 9 For example, when an aqueous solution of silver nitrate, etc., which has high water solubility, is added to latex, the reason for this is not clear.

This destroys the system in which latex is stably suspended in an aqueous solution and causes aggregation, making it impossible to obtain a stable latex composition.

Therefore, in order to manufacture a type of urinary catheter that itself has antibacterial properties by utilizing oligodynamics, the process of molding the catheter as described above and then applying a metal body to its surface or using a metal compound. It requires a process of pulverizing it into fine particles and dispersing it into a suspension, which has low production efficiency and increases manufacturing costs.
This has become a problem.

(Problems to be Solved by the Invention) An object of the present invention is to provide a method for manufacturing an antibacterial urinary catheter in which the urinary catheter itself has continuous antibacterial activity.

Another object of the present invention is to provide a method for manufacturing an antibacterial urinary catheter with high industrial productivity using simple operations.

Another object of the present invention is to provide a method for stably manufacturing an antibacterial urinary catheter using a coating liquid made of a latex composition containing a silver compound.

(Means for Solving the Problems) As a result of extensive research to achieve the above objectives, the present inventors have found that by blending protein silver with high water solubility into natural rubber latex or synthetic rubber latex. The inventors have now found that a latex composition with excellent stability has been obtained, and that the intended purpose can be achieved by using this composition as a coating liquid, thus achieving the present invention.

That is, 1. the present invention provides a latex composition in which protein silver is blended with natural rubber latex or synthetic rubber latex as the coating liquid when manufacturing a urinary catheter by a coating method using a coating liquid made of natural rubber latex or synthetic rubber latex. The gist of the present invention is a method for manufacturing an antibacterial urinary catheter characterized by using an antibacterial urinary catheter.

What is the natural rubber latex used in the present invention?

An aqueous solution containing various organic and inorganic substances that flows out when the bark of a rubber plant is cut is used as a dispersion medium, and the rubber component is used as a dispersoid. It is a latex containing softeners, fillers, anti-aging agents, colorants, etc.

9 Examples of the synthetic rubber latex used in the present invention include 1 monomer polymers of vinyl monomers such as ethylene, styrene, vinyl acetate, vinyl chloride, vinylidene chloride, acrylonitrile, (meth)acrylic acid ester, vinyl pyridine, and methyl vinyl ether. Polymers or copolymers thereof, homopolymers of diene monomers such as butadiene, isoprene, I+3-pentadiene, 1,5-hexadiene, 1) 6-heptadiene, chloroprene, or copolymers thereof, the above vinyl monomers and dienes Copolymers of monomers, and other functional groups such as epoxide groups, amino groups, carboxyl groups, and acid anhydride groups.

The main component is a copolymer of a vinyl monomer having a hydroxyl group, an amide group, an N-methylolamide group, an isocyanate group, etc., and the various monomers mentioned above.

Examples include those containing surfactants, crosslinking agents, fillers, softeners, etc. as necessary.

In the present invention, protein silver is used as an antibacterial agent. Protein silver is a compound of protein and silver.
Silver containing 7.5 to 8.5% by weight of silver listed in the Japanese Pharmacopoeia is preferably used.

The preferred amount of protein silver varies depending on the purpose, but for boat fishing, it is 0.1 to 10% by weight of silver based on the solid content of latex.

In particular, it is preferably 0.5 to 5% by weight.

The method for preparing the coating liquid in the present invention is not particularly limited as long as each component is mixed uniformly, and various known methods can be used. For example, a method of directly adding an aqueous solution of protein silver into the latex is preferably employed.

Any conventionally known method may be used to manufacture a urinary catheter according to the method of the present invention.

For example, urinary catheters are made from natural rubber.

Since it is usually made from natural rubber latex by dip molding, which is one of the coating methods, by specially preparing a natural rubber latex composition containing the protein silver mentioned above as a coating liquid, it can be manufactured using the same manufacturing method as before. can do. In addition, when using other synthetic rubber latex compositions as a coating liquid, similarly, semi-finished products made of the same type of base material or different types of base materials are immersed in the coating liquid, or the coating liquid is sprayed onto the semi-finished product. do. It can be manufactured by a so-called coating method.

Protein silver may be evenly blended into all layers of the catheter, but considering manufacturing costs.

Preferably, it is limited only to the inner and outer surfaces of the catheter. Also, regarding the outer surface of the catheter, from the perspective of avoiding unnecessary irritation to the urethral mucosa.

Protein silver can also be added only to the tip of the balloon that is placed in the bladder.

(Examples) Hereinafter, the present invention will be explained in more detail by giving examples.

Note that "parts" in the two examples mean "parts by weight."

Example 1 Natural rubber latex 100 with a solid content concentration of about 50% by weight
0.3 parts of zinc dimethyldithiocarbamate, 1.5 parts of sulfur, 3 parts of zinc white, and 1.2 parts of stearic acid are uniformly dispersed in 1 part of the compound latex (hereinafter referred to as part A) containing natural rubber as the main component. ) was prepared. On the other hand, 6.4 parts of protein silver was dissolved in 20 parts of distilled water, and this was added to the above solution A1.
A coating liquid was prepared by adding protein silver to 0.00 parts with stirring, and the coating liquid contained protein silver without any agglomeration.

A coating solution (silver 1% by weight) uniformly dispersed in the compounded latex could be obtained.

Using this coating liquid, the immersion mold for S urinary catheter is immersed in the above coating liquid immersion liquid and then pulled out and dried (80°C, 5 minutes) 5 to 7 times using the normal immersion molding method. Repeat, and finally at 70℃ for 10
A urinary catheter was obtained by performing heat treatment for a period of time.

The obtained urinary catheter was cut, and the section was washed with a 70% ethanol aqueous solution in a sterile environment.

After drying and distilling off the ethanol, it was placed on the bottom of a sample bottle with the inner surface facing upward. Next, 200 μβ of E. coli cultured in trypticase soy broth at 37° C. overnight was placed on the inner surface of the section.

After sealing, the cells were cultured at 37°C for 18 hours. Thereafter, physiological saline containing 0.1% surfactant (Tween 80, Sankei Sangyo) was added to the sample bottle to collect the bacterial solution.

When the number of viable bacteria was measured using colony counting method, it was 9.
The number of bacteria recovered was 5. It was OXIO3.

In addition, the urinary catheter of Example 1 was immersed in water at room temperature for one week, dried, and the number of viable bacteria was measured in the same manner as above, and the number of bacteria recovered was 4.2 XIO'. .

Comparative Example 1 A urinary catheter was obtained in the same manner as in Example 1 except that a coating liquid consisting of only liquid A was used as the coating liquid. When the obtained urinary catheter was subjected to an antibacterial activity test in the same manner as in Example 1, the number of bacteria recovered was 8.0 XlO7.

Example 2 3.4 parts of protein silver was added to 8 parts of distilled water as a coating liquid.
A urinary catheter was obtained in the same manner as in Example 1, except that a coating liquid (0.5% by weight of silver) was prepared by dissolving 100 parts of liquid A into 100 parts of liquid A and adding it under stirring to 100 parts of liquid A. An antibacterial activity test was conducted on the urinary catheter in the same manner as in Example 1. As a result, the number of bacteria recovered was 2.
5Xl06.

(Effects of the Invention) According to the present invention, a latex composition in which protein silver is blended with natural rubber or synthetic rubber latex can be incorporated into a normal production line without requiring any special devices or advanced technology. Since a urinary catheter having strong antibacterial activity can be stably manufactured, its industrial significance is extremely large.

Patent applicant: Unikorikiki Co., Ltd. Patent applicant: Sawaya Rubber Industries Co., Ltd.

Claims (1)

[Claims] (1) When manufacturing a urinary catheter by the coating method using a coating liquid made of natural rubber latex or synthetic rubber latex, a latex composition in which protein silver is blended with natural rubber latex or synthetic rubber latex is used as the coating liquid. A method for manufacturing an antibacterial urinary catheter characterized by: