JPH05220216A - In vivo insertion tube - Google Patents

Abstract

PURPOSE:To provide an antibacterial in vivo insertion tube-like product, e.g. a catheter, and other various medical tubes. CONSTITUTION:Medical tubes consist of an in vivo insertion tube 1 uniformly mixed with an antibacterial agent 3 at least at an in vivo insertion portion 2 and an in vivo insertion tube covered with an antibacterial agent-containing layer 13 on the outer periphery and/or the inner periphery of at least an in vivo insertion portion 12. They have sufficient antibacterial property against colibacillus and yellow staphylococcus, they can be maintained in the constant state for a long period without causing such problem as base discoloration, they are sanitary, and they can be confidently used for a treatment.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a tube-shaped product for insertion into a body, such as a catheter, and various medical tubes. More specifically, the present invention relates to a catheter or medical tube made of a thermoplastic resin or rubber capable of exerting an excellent antibacterial property at least at a site to be inserted into the body. The various medical tubes include digestive tract tube, intraoral tube, endotracheal tube, intrathoracic tube and intraperitoneal tube.
Tube, rectal tube, intracranial tube and the like.

[0002]

BACKGROUND OF THE INVENTION In recent years, infusions have been remarkably expanded in applications from electrolyte infusions to high-calorie infusions, but side effects are also increasing. Among them, complications due to catheter are roughly classified into those associated with insertion procedure and those due to indwelling and fixation. The main complications are phlebitis, bacterial infection, and catheter embolism, and long-term catheter implantation involves many risks of infection. It is known that when phlebitis occurs, redness and pain may be observed along the puncture site or along the vein and fever may accompany, and side effects such as endophthalmitis and encephalopathy may occur due to bacterial infection. In particular, if there is an infection in the body, create a new infection around the catheter. Conventional catheters are mainly composed of polyvinyl chloride, polyurethane, etc., but some of them coated with antithrombotic agents such as urokinase have been clinically evaluated, but they are not completely effective for infection prevention. Not a thing.

Conventionally, the antibacterial activity is imparted by means of chemically bonding an antibacterial agent of an organic substance (Japanese Patent Publication No. 24544) or providing a coating layer containing the antibacterial agent (Japanese Patent Publication No. 27213). Since the antibacterial agents are water-soluble, there is a problem that they fall off from the base material during the indwelling.
Further, as the inorganic substance, an example of using as particles of silver, gold or copper having a diameter of about 30 μm or less (Japanese Patent Publication No. 21269/1990).
However, there was a problem that the particles were not sufficiently small and were not uniformly dispersed, and when they were made into a suspension, they settled.
Further, silver ions are liable to react with each other, and when silver ions are directly contained, they react with a substrate or the like and lose antibacterial activity. Further, the silver zeolite-based antibacterial agent has a problem that the water of crystallization contained in the zeolite is volatilized during heat molding and the structure is broken, so that the base material is discolored.
Therefore, the inventors of the present invention have earnestly studied to solve the above problems, and have arrived at the next invention.

[0004]

DISCLOSURE OF THE INVENTION The present invention provides a tube 1 for insertion into a body characterized in that an antibacterial agent 3 is uniformly mixed at least in a body insertion site 2. Further, the present invention is
Provided is a tube 11 for insertion into a body, which is characterized in that at least an outer peripheral surface and / or an inner peripheral surface of a body insertion portion 12 is covered with an antibacterial agent-containing layer 13.

FIG. 1 is a schematic view of a tube 1 for insertion into the body of the present invention. The tube 1 for insertion into the body is composed of a thermoplastic synthetic resin such as polyvinyl chloride resin, polyethylene or polyurethane, or a flexible material such as silicone rubber.

The tube 1 for insertion into the body has an insertion site 2 inside the body.
The antibacterial agent 3 is uniformly dispersed and mixed therein. Antibacterial agent 3
Is an antibacterial inorganic fine powder, and is a silver-substituted inorganic ion exchanger having a particle size of 2 μm or less, and a zirconium-based inorganic ion is used. As the most preferable antibacterial agent, a silver-substituted zirconium ion exchanger containing no water of crystallization is used.

FIG. 2 shows another tube 11 for insertion into the body.
3 to 5 are enlarged views of the portion A of FIG. As shown in FIG. 3, the tube 11 for insertion into the body has a layer 13 containing an antibacterial agent (hereinafter referred to as an antibacterial agent containing layer 13) which is inserted into the body 1
The outer peripheral surface of No. 2 is covered.

The antimicrobial-containing layer 13 may be formed on the inner peripheral surface of the body insertion site 12 as shown in FIG. 4, or may be formed on the outer peripheral surface and the inner periphery of the body insertion site 12 as shown in FIG. It can be formed on both sides.

As described above, in the tubes 1 and 11 for insertion into the body of the present invention, the particle size of the antibacterial agent 3 (including those added to the antibacterial agent containing layer 13) is set to 2 μm or less, and Since it is uniformly dispersed in the flexible base material or the antibacterial agent-containing layer, the antibacterial activity can be maintained for a long time. Further, by using a zirconium-based exchanger that does not contain water of crystallization, the problems caused by the water of crystallization of conventional silver zeolite antibacterial agents can be solved.

[0010]

Example 1 A plasticizer (dioctyl phthalate, hereinafter DHEP), epoxidized soybean oil, calcium stearate, with the composition shown in Table 1 per 100 parts by weight of polyvinyl chloride resin (hereinafter PVC), Zinc stearate was added, and a silver-substituted zirconium ion exchanger was added as an antibacterial agent at 0.05, 0.1,
0.5, 2.0, and 4.0 parts by weight of each were added, mixed with a Hensyl mixer, and then an extruder with an inner diameter of 3.0 at 170 ° C.
A tube having an outer diameter of 5.0 mm and an outer diameter of 5.0 mm was molded at a speed of 15 mm / min.

[0011]

[Table 1] Composition

Example 2 100 parts by weight of polyethylene was dry-blended with 0.1 part, 0.5 part, 1.0 part, 2.0 part, and 4.0 part of a silver-substituted zirconium ion exchanger, and an extruder was used. At 200 ° C., a tube having an inner diameter of 3.0 mm and an outer diameter of 5.0 mm was molded.

Example 3 A tube was prepared in the same manner as in Example 1 without adding an antibacterial agent, and the tube was dipped into a dipping solution (100 parts by weight of vinyl chloride paste resin, 50 parts by weight of DHEP and calcium starch). 1 part by weight of allate, 1 part by weight of zinc stearate, and 0.1, 0.5, 1.0, 2.0, 4.0 parts by weight of antibacterial agent (silver-substituted zirconium ion exchanger). Mix, degas, and soak in), pull up to 1
The mixture was heated and cured at 20 ° C. for 10 minutes to form an antibacterial agent layer on the tube surface.

Evaluation of Antibacterial Property Each tube prepared in Example 1 was cut and a sheet of 5 cm × 5 cm was prepared by a heating press. 0.2 ml of bacterial solution (E. coli solution, Staphylococcus aureus solution) was inoculated into this sheet and stored at 35 ° C., after which surviving bacteria were washed out and the viable cell count was measured by the pour plate culture method. It was converted to the number of viable bacteria per sheet. The results are shown in Table 2.

[0015]

[Table 2]

From the results shown in Table 2, the polyvinyl chloride resin mixed with 0.05 parts by weight or more of the antibacterial agent showed sufficient antibacterial activity against Escherichia coli and Staphylococcus aureus. On the other hand, if the amount of the antibacterial agent added is less than 0.05 parts by weight, sufficient antibacterial properties are not exhibited, and if it exceeds 5.0 parts by weight, the polyvinyl chloride resin becomes white and opaque, which is not preferable. The preferable range of the addition amount of the antibacterial agent is 0.1 to 4.0 parts by weight.

The tubes prepared in Examples 2 and 3 were also evaluated for antibacterial properties in the same manner as in Example 1. In each tube, the amount of antibacterial agent added was 0.1 to 4.0. It was confirmed that sufficient antibacterial properties were exhibited in the range of parts by weight.

[0018]

INDUSTRIAL APPLICABILITY As described above, the tube for insertion into the body of the present invention exhibits sufficient antibacterial activity against Escherichia coli and Staphylococcus aureus, and is constant for a long time without causing a problem such as discoloration of the substrate. Since the condition can be maintained, it can be used for treatment with hygiene and peace of mind.

[Brief description of drawings]

FIG. 1 is an enlarged sectional view of a tube for insertion into a body of the present invention.

FIG. 2 is an enlarged sectional view of the tube for insertion into the body of the present invention.

3 is an enlarged view of part A of FIG.

FIG. 4 is an enlarged view of part A of FIG.

5 is an enlarged view of part A of FIG.

[Explanation of symbols]

 1, 11 Tube for insertion into body 2, 12 Body insertion site 3 Antibacterial agent 13 Antibacterial agent-containing layer

 ─────────────────────────────────────────────────── ─── Continuation of the front page (72) Inventor Hiroki Goshima 1-7 7 Tamada, Mie-machi, Ono-gun, Oita Prefecture Kawasumi Chemical Industry Co., Ltd. Mie factory

Claims (5)

[Claims] 1. A tube 1 for insertion into a body, wherein an antibacterial agent 3 is uniformly mixed at least in a body insertion site 2. 2. A tube 11 for insertion into a body, wherein at least the outer peripheral surface and / or the inner peripheral surface of the body insertion portion 12 is covered with an antibacterial agent-containing layer 13. 3. The antibacterial agent according to claim 1 or 2 is used in an amount of 0.0 with respect to a base material constituting a tube for insertion into a body.
Tube 1 (11) for insertion into the body, characterized by being added from 5 parts by weight to 4.0 parts by weight. 4. A tube 1 (11) for insertion into a body, wherein the antibacterial agent according to any one of claims 1 to 3 is a silver-substituted inorganic ion exchanger having a particle size of 2 μm or less. 5. A tube 1 (11) for insertion into a body, wherein the inorganic ion exchanger according to claim 4 is a zirconium type.