JP3091396B2 - Medical catheter - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an improvement in the lubricity of a tube surface of a soft vinyl chloride resin catheter generally used in the medical field.

[0002]

2. Description of the Related Art Tubes made of a soft vinyl chloride resin are used not only for circuits and connection tubes used outside the body such as blood circuits and infusion circuits, but also for endotracheal tubes used for anesthesia and respiratory management.
, A gastrointestinal catheter for injecting and exhausting a drug solution in the digestive tract, a drainage tube for discharging body fluid such as blood from an affected part after surgery, and the like, which are used for various medical catheters inserted into the body. . It is selected because it is inexpensive, has excellent processability, and has high safety, and is recognized as a proven general-purpose material for medical use.

[0003] When a catheter is used as a conduit through which a body fluid such as blood or a drug solution or a gas such as air passes, even if it is inserted into the body and used, long-term antithrombotic properties and stability during indwelling are not a problem. Tub made of soft vinyl chloride resin
There is no problem at all. However, when a medical device is used in such a manner as to insert another medical device into the lumen of the catheter, for example, when saliva or secretion fluid stored and stored by inserting a small-diameter suction catheter into the lumen of the endotracheal tube is suctioned and discharged, Alternatively, a guide wire is used to aspirate and discharge the gastrointestinal tract and inject the drug solution.
When the catheter is guided to a deep part of the digestive tract while adjusting the hardness and rigidity of the catheter using a stylet or the like, lubricity between the inner surface of the catheter and the inserted medical device is required. In that case, the catheter made of soft vinyl chloride resin,
It cannot be said that it is superior to other materials.

[0004] Various techniques have been devised as conventional techniques for improving the lubricity between the inner surface of the catheter and the inserted medical device. An example is as follows. Mixing a silicone resin layer or a silicone resin-silicone rubber copolymer layer or a mixture of silicone resin and silicone oil on the inner surface and / or outer surface of a silicone rubber tube used in an endotracheal tube or the like. Layer, and a silicone oil coating layer is further provided on the surface thereof (Japanese Patent Laid-Open No. 63-1).
64956). A lubricating protective layer containing a slip agent is formed by treating the surface of a medical device with a coating liquid comprising an aqueous urethane dispersion and a silicone or siloxane emulsion (Japanese Patent Laid-Open No. 3-51052). . A lubricating coating made of a crosslinked polysiloxane polymer containing silicone oil is applied to the surface of a vascular catheter (Japanese Patent Application Laid-Open No. 2-289264).

[0005] A polymer material of a medical device is swollen with a polar solvent, a hydrophilic polymer compound dissolved in the polar solvent is impregnated into the polymer material, and the polymer material is brought into contact with water to obtain lubricity on the surface (particularly). Kaihei 6-7426). The surface of a polyurethane resin having an unreacted isocyanate group is sequentially treated with polyethyleneimine, a maleic anhydride copolymer, and water, whereby the surface is easily lubricated in the presence of water by drying. (Japanese Unexamined Patent Publication No. 2-2266)
6). Lubricity treatment method for medical device surface
9366).

[0006] The former is a means of coating a silicone resin or oily substance on the surface, and the latter expresses lubricity when used in contact with water by hydrophilic treatment or fixation of a hydrophilic polymer. It is a means to make it. By these means, highly practical products are provided to medical sites.
However, when applied to a medical catheter, a step of applying a coating agent different from the base material to the catheter tube is required, and a rise in manufacturing cost is unavoidable. In addition, depending on the bonding method and process content of the surface treatment, it is recognized that various base materials can be selected and the physical properties and functions as a catheter have the advantage of being widened, but the coating having lubricity is limited to the surface. Therefore, there is a risk that the durability and the coating quality may vary.

[0007]

SUMMARY OF THE INVENTION The present invention has been studied variously in order to solve such problems of a catheter made of a soft vinyl chloride resin widely used in the medical field. Its purpose is to provide lubricating properties to the catheter at low cost and without variation in its durability and quality, so that it can be slid with other medical instruments that are inserted or contacted into the catheter when used at medical sites. An object of the present invention is to provide a medical soft vinyl chloride resin catheter excellent in dynamic operability.

[0008]

That is, the present invention relates to a medical catheter, wherein a tube constituting a main tube of the catheter is made of a soft vinyl chloride resin having a degree of polymerization of 1,000 to 7000, and the compounding composition of the resin is silicone. The oil is contained in an amount of 1 to 5 parts by weight based on 100 parts by weight of the soft vinyl chloride resin component, and the acrylic resin is contained in the soft vinyl chloride resin component 10.
A medical catheter characterized in that 0.5 to 5 parts by weight is contained with respect to 0 parts by weight. The soft vinyl chloride resin used in the present invention is a homopolymer of vinyl chloride or a copolymer mainly containing vinyl chloride and a mixture thereof.
It is a composition to which a plasticizer for imparting flexibility, a stabilizer for imparting thermal stability, and other processing agents are added.

The plasticizer can be freely added. However, when the vinyl chloride resin component is 100 parts by weight, considering the appropriate flexibility, elasticity and hardness of a medical catheter, 30 parts are required.
１２０120 parts by weight is desirable. As the plasticizer to be used, aliphatic esters such as phthalic acid esters and aliphatic dibasic acid esters, polyesters, soybean epoxide oil, epoxidized linseed oil and the like are desirable. Further, it is also possible to add a non-liquid polymer that imparts flexibility to the vinyl chloride resin, for example, polyurethane, ethylene-vinyl acetate copolymer, or the like. Stabilizers that provide thermal stability include calcium,
A metal soap based stabilizer such as zinc or an organic metal based stabilizer thereof can be used, but from the viewpoint of safety, a calcium or zinc based stabilizer is particularly preferable for a medical catheter.

The silicone oil used in the present invention is a non-reactive silicone oil, for example, dimethyl silicone oil, phenylmethyl silicone oil, chlorophenyl silicone oil, alkyl silicone oil, fluorosilicone oil, polyoxyalkylene. Modified silicone oil, aliphatic ester-modified silicone oil and the like. From the viewpoint of physiological stability, dimethyl silicone oil or phenylmethyl silicone oil is desirable for medical use. The viscosity is 5 to 10 according to JIS K6833.
It is 10,000 cs, and 100 to 1000 cs is suitable for obtaining a suitable lubricating property with an appropriate amount of bleed on the tube surface.

The degree of polymerization of the vinyl chloride resin component is an important factor that affects the physical properties of a molded article made of a soft vinyl chloride resin. In a medical catheter, a resin having a degree of polymerization of 1000 to 7000 can be used. A catheter to be inserted into the body during use generally requires flexibility. Soft vinyl chloride resin has temperature dependence on hardness, and softens due to body temperature during insertion into the body. When the guide wire or stylet enters the tube at the time of insertion, the tip of the guide wire or stylet will be separated by the contact area. A trouble occurs that the tube is bent. Therefore, it is necessary to maintain physical properties such that extreme softening does not occur even at body temperature while maintaining appropriate flexibility, it is desirable that the rubber-like elasticity is rich, and the degree of polymerization of the vinyl chloride resin component is relatively high. High is preferred. However, the higher the degree of polymerization, the poorer the moldability. In particular, since the silicone oil blended for obtaining the lubricity of the surface exerts an excessive lubricant action in the resin kneading step and the molding step, as in the present invention, when the additive amount is more than the processing aid level, the The degree of polymerization has a limit in consideration of the properties and economy. Therefore, 1800 to 3000 is preferable.

It is important that the addition amount of the silicone oil be kept to a minimum level at which surface lubricity can be obtained.
The reason for this is that, as described above, since the addition exceeds the normal processing aid level, insufficient kneading occurs due to excessive lubrication with the resin kneader, and excessive lubrication with the screw during extrusion molding. As a result, insufficient kneading occurs and the melt strength of the extruded resin decreases. As a result, molding is difficult, or even if molding is possible, only tubes having poor transparency and surface smoothness can be obtained. To compensate for this, a special screw with excellent kneading performance is required, and there is an economic loss such as a decrease in productivity.
Another reason is that, in the present invention, the blended and added silicone oil gradually bleeds and forms a lubricating layer of oil on the surface of the molded product, thereby reducing the sliding resistance of the contacting guide wire or stylet. It is to reduce. Therefore, the amount of oil that bleeds may be small, and excessive bleeding may cause a biochemical ill effect of diffusing into the body during indwelling as a medical catheter, and may cause the catheter to function as a catheter. This is because the impregnation of the oil with the oil impinges on the joint surface or the adhesive surface with the component attached to the tube. Although it depends on the use of the medical catheter, 1 to 5 parts by weight is suitable for 100 parts by weight of the resin component.

[0013] The degree of polymerization of the vinyl chloride resin component and silicone
The preferred conditions for the amount of oil added are as described above, but when a combination is selected for the high polymerization degree and high addition amount side, gel is used to increase the degree of kneading by increasing the adhesiveness to the kneader or screw in the kneading step. It is preferable to add 0.5 to 5 parts by weight of a methyl methacrylate and an alkyl acrylate copolymer as a processing aid for accelerating the conversion depending on the situation. The composition of the soft vinyl chloride resin other than those described above is used for general medical catheters and is not particularly specified. For example, the formulation of a contrast agent that imparts X-ray contrast as a catheter is naturally included.

Further, the medical catheter according to the present invention is constructed using the main pipe made of the above-mentioned soft vinyl chloride resin. The main tube is a tube formed by extrusion, and has a single-chamber or multi-chamber cross section and is generally substantially circular. A medical catheter may be provided with one or more balloons depending on the application. In addition, the tip has an opening or sealing shape, a side hole communicating with the lumen of the main pipe is opened in the pipe wall as necessary, and the terminal is provided with a branch pipe connected to each lumen. Sometimes. That is, the above-mentioned main pipe made of a soft vinyl chloride resin can be used for various types of catheters depending on the use of the medical catheter.

[0015]

DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention will be described below with reference to embodiments. For 100 parts by weight of a vinyl chloride resin (manufactured by Sumitomo Chemical Co., Ltd.), 30 to 75 parts by weight of di-2-ethylhexyl phthalate (DOP) as a plasticizer and epoxidized soybean oil 1
00 parts by weight, 2.5 parts by weight of a calcium-zinc stearic acid composite stabilizer as a stabilizer, 0.3 parts by weight of butyl stearate as a lubricant, and polymethylphenylsiloxane as a lubricant (Toray Dow Silicone Co., Ltd.)
Co., Ltd., SH-550, 130cs) and a processing aid as a copolymer of methyl methacrylate and butyl acrylate in a copolymerization ratio of 9: 1 (Mitsubishi Rayon Co., Ltd., Metablen P-530)
A polymerization degree of 3,000,000) and vinyl chloride resin polymerization degree are shown in Table 1.
After mixing with a super mixer and kneading and granulating with a co-kneader, the outer diameter of the main tube of the medical catheter is 5.7 mm and the inner diameter is φ40 mm extruder (full flight screw, CR4.4) A 2.7 mm tube was molded. The DOP, polymethylphenylsiloxane, and processing aid compounded in Table 1 are all shown in parts by weight based on 100 parts by weight of the vinyl chloride resin.

[0016]

[Table 1]

The evaluation of the resin kneading properties was carried out by evaluating the plasticization of pellets after granulation (Labo Plastmill, manufactured by Toyo Seiki Seisaku-sho, Ltd., test temperature 140 ° C., mixer R-60) and steady torque and steady torque time. Was evaluated. FIG. 1 schematically shows reading of each value on the chart. As for the moldability of the extrusion molding, the molding speed, the surface of the tube and the transparency were evaluated. Thereafter, assuming that the medical device was manufactured as a disposable medical device, the device was cut into a total length of 3 m and then subjected to washing / EOG sterilization. The lubrication of the tube was evaluated by measuring the pull-out resistance of a guide wire (manufactured by Sumitomo Akita Bake Co., Ltd., outer diameter 0.052 inch, total length 3.5 m). The tube containing the guide wire was inserted into a metal tube having an inner diameter of 10 mm having a bent portion of R100 mm * 90 degrees at five places, and the tube was fixed at the tip of the metal tube. A metal tube and a tube were fixed on a table, and only a guide wire was 56 cm / min. The tube was pulled out of the tube at a pulling speed of, and the pulling load at that time was relatively compared in terms of% with respect to the control as 100. Table 2 shows the evaluation results.

[0018]

[Table 2]

NO1 is a conventional product of the main tube of a medical catheter used as an intestinal drainage tube. This is an embodiment in which this is controlled to improve the present invention. If the amount of silicone oil added is increased to 1.0 or 1.25 with respect to NO1, the pulling load decreases with NO3, but the plasticizing properties deteriorate and a good tube cannot be obtained. However, in the case of NO4 to which a processing aid has been added, it is necessary to increase the amount of silicone oil added, but improvements in plasticizing properties and moldability are observed. In addition, a tube having a low balance of plasticization characteristics, moldability and pulling load was obtained with NO5 in which the degree of polymerization of the vinyl chloride resin was slightly lowered. Further, in order to see the effect of the degree of polymerization, a better tube was obtained as compared with NO3 having the same silicone oil addition amount as NO6.
Is obtained. If the addition amount is further increased, the tube will not be formed. However, comparing the degrees of polymerization, the lower the degree of polymerization, the easier it is to add oil, and the more easily lubricity is obtained. With NO8 having the same composition as NO5, similarly good tubes were obtained. Further, when the effects of the number of plasticizers were examined for NO9 and NO10, good tubes were obtained, which were almost the same as NO5, which was good. Since the granulation, moldability and appearance of the tube differ depending on the kneading machine and the extruder, in particular, the screw design, the degree of polymerization of the vinyl chloride resin, silicone oil and processing aids were determined as in this example. It is important to balance the amount of agent added.

Next, the shape and structure of the medical catheter manufactured according to the present invention will be described with reference to one embodiment. This embodiment is a tube for treating and treating intestinal obstruction, and its schematic view is shown in FIG. The main pipe (1) has a three-chamber sectional shape and a balloon (2)
It has an outer diameter of 5 mm and an effective length of 3 m, which has a lumen for inflation (3), a lumen for suction (4) and a sample-membrane (6) for releasing excessive suction from the side hole (5). A branch pipe (8) is provided at the rear end branch (7) for airtight connection to each of the above-mentioned cavities, and a connector (9) for connection is provided at the rear end. On the other hand, a silicone rubber balloon (2) is attached to the outer periphery of the main pipe (1) near the tip, and connectors (9),
The branch tube (8) and the inflation lumen (3) can be arbitrarily expanded and contracted. In addition, balloon (2)
A plurality of side holes (5) communicating with the suction lumen (4) are opened in the pipe wall of the main pipe (1) before and after the above. Further, a guide portion (10) for guiding the traveling direction flexibly when a catheter on the wall of the digestive tract abuts is provided at the forefront of the main tube (1). In this embodiment, the catheter is used for the gastric pylorus and Tre.
The insertion operation near the iz ligament is important. A guide wire is inserted into the suction lumen (4) of the main tube (1), and the catheter is pushed into the body while adjusting the insertion depth to adjust the hardness of the main tube (1). Through.
At this time, lubricity between the main pipe (1) and the guide wire is required.

[0021]

According to the present invention, the conventional problems of the medical catheter made of a soft vinyl chloride resin which has been widely used in the medical field can be solved and a medical instrument such as a guide wire to be inserted can be provided. A highly lubricating material having excellent sliding operability can be easily provided at low cost without variation in quality and without changing the conventional manufacturing process.

[0022]

[Brief description of the drawings]

FIG. 1 is a schematic diagram of measurement results of plasticization evaluation.

FIG. 2 is a schematic view of a tube for examination and treatment of intestinal obstruction according to one embodiment of the present invention. 1. Main pipe 2. Balloon 3. Inflation lumen 4. 4. Lumen for suction Side hole 6. Sample-Men 7. Branch part 8. Branch pipe 9. Connector-10. Guidance section

Claims (2)

(57) [Claims] 1. A medical catheter, wherein a tube constituting a main tube of the catheter has a degree of polymerization of 1,000 to 700.
0 to 5 parts by weight of silicone oil in 100 parts by weight of soft vinyl chloride resin component, and 100 parts by weight of acrylic resin in 100 parts by weight of soft vinyl chloride resin component. 0.5 to 5 parts by weight of the medical catheter. 2. The method according to claim 1, wherein the acrylic resin is methyl methacrylate,
The medical catheter according to claim 1, which is an alkyl acrylate copolymer.