JPS60126163A - Medical tube with balloon - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

DETAILED DESCRIPTION OF THE INVENTION Field of Industrial Application The present invention is characterized in that a tube body made of a soft vinyl chloride resin and a balloon made of silicone rubber are bonded together using a silicone composition. This invention relates to a medical tape with a balloon.

Conventional technology in the medical field (= urinary catheters such as indwelling urinary catheters, endotracheal tubes, digestive catheters, cardiac catheters, etc. Balloon catheters with a thin balloon at the tip or middle of the tube, etc. Medical chips with balloons are often used.The materials of the chip body and balloon used in these devices include latex, silicone rubber, soft vinyl chloride resin, and polyurethane. The same material has been used for the balloon body and the balloon.
Its purpose of use (depending on the 2), but when not in use, the diameter is the same as or slightly larger than the tube body.
When using a balloon with a gas such as air or a liquid such as a reduced volume of physiological saline (a relatively small volume balloon that can be fully expanded), and when pre-expanded (= similar shape or
Type 2 with a shape assuming a large expansion state
There are seeds.

In order to obtain a large elongation rate, elastomers such as rubber elasticity (1), silicone rubber, and latex are often used, and balloons made of vinyl chloride resin and polyurethane are generally Those with similar shapes are used, and highly elongated ones cannot be obtained.

On the other hand, the tube body can be made of any material; For various purposes (second, a material with relatively high rigidity is desired. Silicone rubber and latex have relatively low rigidity when viewed as tube materials, so to prevent bending etc. when using tubes (= For this purpose, it is necessary to increase the tube wall thickness.
However, since the strength is still insufficient for two tubes, measures are taken such as using a spiral metal wire as the middle layer of the tube (two people can fit together).In this respect, vinyl chloride tubes and urethane tubes It is extremely easy to obtain high rigidity because it can be freely adjusted from high to low rigidity.

Medical tubes with balloons require appropriate selection of materials for the balloon and tube body depending on the purpose and use. Conventionally, the tube body has high rigidity and the balloon has high elongation. If required, the tube material may be vinyl chloride resin alone, polyurethane resin alone, silicone rubber reinforced with metal, glass fiber, etc.
Latex or the like has been used, and silicone rubber, latex, etc. have been used as palcone.

Problems to be Solved by the Invention However, if the material of the tube body and the material of the balloon are different, it is difficult to bond them together.
For example, methods have been used such as tying both ends of the balloon from the outside with string or fixing both ends with elastic bands. However, even when a thin thread is used, there are problems in that the fixation part (= undulation) occurs, making it difficult to insert the tube into the body and damaging the mucous membrane at that part.

Structure of the Invention The inventors of the present invention have conducted intensive research to improve the drawbacks of conventional products, and have discovered a formulation of a two-strong (bi-adhesive) Tekyl adhesive that combines silicone rubber and soft vinyl chloride resin with each other. The technology (2) is to invent a tube with a balloon, which uses a transparent and sufficiently rigid soft vinyl chloride resin for the tube material (:), and uses silicone rubber for the balloon, and integrates the two with adhesive. Two reached.

That is, the present invention provides a balloon-equipped medical tube having one or more balloons, wherein the balloon is made of silicone rubber, the tube body is made of a soft vinyl chloride resin, and the tape and the balloon are made of an addition-polymerized silicone composition. A cured layer of an addition-polymerizable silicone composition is previously provided on the entire body of the balloon-attached medical tape or 'f':=--bead body, or at least on the portion to be bonded to the balloon, which is adhered by the adhesive cured layer. Next, the same reduced-length RT'v silicone rubber composition as used for making a normal silicone balloon catheter consisting of a silicone rubber Tuniff body and a silicone rubber balloon, or an addition polymerization type silicone composition (two Therefore, it is an object of the present invention to provide a medical tube with an adhesively integrated balloon.

The soft vinyl chloride resin and addition-polymerized silicone composition used in the present invention (the details are described in the prior patent application of the present inventors), but what is the vinyl chloride resin material used here? , a vinyl chloride homopolymer, a vinyl chloride-based copolymer, a mixture thereof, a plasticizer to impart flexibility, a stabilizer to impart thermal stability, and other auxiliary agents. .

The plasticizer can be added freely in the range of 0 to 100 parts when the amount of the resin component is 100 parts. As the plasticizer used, fatty acid esters such as phthalic acid esters and aliphatic dibasic acid esters, polyesters, epoxidized soybean oil, epoxidized linseed oil, etc. are preferable. It is also possible to add non-liquid polymers that impart thermal stability, such as polyurethane, ethylene-vinyl acetate copolymer, etc. Stabilizers that impart thermal stability include calcium, magnesium,
Stabilizers based on metal soaps such as zinc or organometallic stabilizers can be used, but stabilizers based on dicalcium or zinc are particularly preferred.

Adhesive hardening layer for adhesion between cheese and balloon.

Alternatively, the silicone composition for forming a hardened layer etc. on the tube surface is an addition polymerization type silicone composition consisting of the basic components shown in formula (1) and @formula (2) (1), and a platinum-based catalyst. (: Therefore, it is a material that cures by heating, and the heating conditions are preferably 40 to 120°C and a material that cures within 10114 degrees Celsius.In addition, if you want to obtain stronger adhesion, epoxy compounds, carboxylic acid anhydrides, etc. thing,
A silane or siloxane containing an acryloxyalkyl group or an oxirane compound containing an unsaturated hydrocarbon may be added.

(2) Preferably, an addition-polymerizable silicone composition is applied (= prior to the application of an organohydrogen lochitin unit represented by formula (3) as an anchoring agent, at least 30 mo1% or more, preferably 4Q mo1% or more) If organohydrogen polysiloxane is coated on the surface of a vinyl chloride resin tube to form a thin film, its adhesive strength will be further improved.

In the formula, the balloon material in the present invention (=) is a silicone rubber with high elongation and high elasticity, and may be either a silicone rubber vulcanized with peroxide or an addition polymerization type silicone rubber.

The method for manufacturing medical tubes with balloons according to the present invention (- is not particularly limited, but for example, the tubes made of vinyl chloride resin can be manufactured using an extruder (bi-twisted tube shape (1
After forming and cutting to the appropriate length, the ends are processed.

In addition, silicone rubber balloons can be made by conventional tube extrusion methods, press molding, differential ipping molding, chiro molding, etc. A silicone rubber balloon is heated and integrally molded using the addition-polymerizable silicone composition described above as an adhesive layer.

In addition, after applying the addition polymerization type silicone composition mentioned above (2) to a part or the whole of the vinyl chloride resin tape body, at least to the part to which the balloon is attached (2),
The adhesive cured at a temperature of 30°C, preferably 80 to 120°C for 5 minutes to 10 hours, preferably 10 minutes to 3 hours, is a silicone rubber balloon using a condensation type RTV silicone composition as an adhesive layer. It can be integrally molded with. Alternatively, the addition polymerization type silicone composition previously used as the adhesive layer may be heated and integrally molded. The method for coating the tube body with the addition polymerization type silicone composition is the dipping method. If the viscosity is too high, use toluene, hexane,
It may be diluted with a solvent such as acetone or trichloroethane.

The medical tube with a balloon made of vinyl chloride resin/silicone rubber composite obtained in this way has the rigidity of vinyl chloride resin and the balloon properties of silicone rubber, (For those with a silicone rubber layer, this silicone rubber is an addition polymerization type silicone composition, so it was cured by heating at a relatively low temperature of 120°C or less.) Because there are almost no It is extremely effective in the medical field.

The present invention will be explained below with reference to Examples.

Example Vinyl chloride resin (S-101' manufactured by Sumima Kagaku Kogyo ■) 1
00 parts by weight (in terms of metal weight, 0.03 parts by weight of zinc stearate, 0.02 parts by weight of calcium stearate, 45 parts by weight of diethylhexyl phthalate, and 10 parts by weight of epoxidized soybean oil) were mixed in a blender (two parts by weight). Did you?Na
-Grain, 4Qm! Iφ extruder (see Table 1): two types of dubs A, C, E and B, D with the sizes shown and a fluid passage for balloon inflation of approximately Q, 5 txmφ.

・Mold a lumen tube, cut each into two pieces of 50 degrees long, and heat seal the tip (two pieces) to create a tube body.

On the other hand, the balloon is silicone rubber K manufactured by Shin-Etsu Chemical Co., Ltd.
Balloons of two sizes shown in Table 1 were molded using E 540-u, and each balloon was cut into 2 cMl lengths.

Next, the tube bodies of A and B (2) were coated with an anchoring agent. An n-chitin solution containing 2.0% by weight of a certain methyl ice candy polysiloxane was prepared by applying this solution to each tube body (two thin coats and drying at 100°C for 15 minutes. Among the tube bodies A, IJC, D, and E, B
and D (= means n- and xane solutions (24° and 20% by weight, respectively) of the addition-polymerized silicone rubber shown in Table 1 were coated by a dipping method (2), and each was coated at 100°C.
It was heat-cured for 90 minutes and at 110° C. for 40 minutes.

Next, these five types of the balloon forming part side holes of the balloon inflation fluid passage of the vinyl chloride resin tube body, A, C, E+: are about 0.3g-, B, D (two are about 0, After drilling a hole of 6 mm in diameter, cover each tube body C with the aforementioned 2 cm long balloon, leaving a gluing margin of approximately 4 Wit (:, L/, each according to Table 1 (1). At this time, B, D, and E were bonded together at room temperature using an RTV silicone composition, and A and C were bonded at 110°C using an addition polymerization type silicone composition. , (9) minutes and -10011
? It was heated and bonded for 60 minutes.

Thereafter, necessary post-processing was performed to create a vinyl chloride resin/v silicone rubber composite balloon catheter. The following tests were conducted using the above balloon catheter.

The test results are shown in Table 2.

(Leak test) Balloon inflation fluid passages (2, A, C, E each have 2c
After introducing 1 Qcc of air into each of C, B, and D I-, and sealing each passage with a stopper, the balloon portion was immersed in physiological saline (1 for about 30 minutes) to check for leaks.

(Adhesion test) Fluid passage for balloon inflation (two airs are gradually fed in,
Measuring the amount of air when the balloon inflation part breaks
2. Carefully observe the adhesive part between the tube body and the balloon (
I did one line.

In addition, FIGS. 1 and 2 ('-1 and 2) are cross-sectional views of the balloon catheter according to the present invention as examples. A cross-sectional view is shown in Figure 3.

'*'1 Silicone composition I 100 parts of dimethylpolysiloxane having a viscosity at 25°C (25°C) of 18,000 OS and having dimethylvinylsilyl groups at both ends of the molecule (2:2, 10 mo1% of trimethylsiloxane units, dimeterne loxane unit 4Qmo
1%, 5 parts of a polysiloxane consisting of 50 mo1% of methylhydrogen silochitin units, 0.2 parts of an isopropyl alcohol solution of chloroplatinic acid (platinum content: 1%), and 2 parts of a solution of chloroplatinic acid (platinum content: 1%) were added.

2 Silicone Composition I 100 parts of dimethylpolysiloxane (2 to 2, conventionally known (CHa)3Sin) having a viscosity of 11,008 at 8°C and having dimethylvinylsilyl groups at both ends of the molecular chain.

,, unit and (CH,=CH) (CH8% 5in0.
, a copolymer consisting of units and 8io2 units (however, C
Hs )s S r 00.5 units and (CH,=CH)
(CH,)2S i, the ratio of the sum of the units to the number of 5i02 units is 0.8:1, the vinyl group contained is 0.9%), 15 parts, trimethylsilyl treated atomized 25 parts of silica, 5 parts of methylhydrogen polysiloxane having a viscosity of 5008 at 25°C and approximately 50 mo1% of methylhydrogensiloxitin units, and 0.2 parts of isopropyl alcohol solution of chloroplatinic acid (platinum content: 1%). 1 part, 2 parts of an epoxy compound with the structural formula of Chiji Sara to C=” CH-C
H, -0-CH2-CH-CH2N2 Adjusted by adding 0.5 part of phthalic anhydride.

Effects of the Invention As can be seen from Table 2 (''-1 Comparative Example E, in which a PVC resin tube body and a silicone rubber balloon are combined, the conventional balloon attachment cannot be integrated with adhesive using silicone rubber. , the present invention (2) Balloon catheters A, B, C, and D have been successfully integrated with a tape body made of vinyl chloride resin and a balloon made of silicone rubber (2), and are practically sufficient (1) usable and high quality. This is a highly functional and high value-added balloon catheter.

[Brief explanation of drawings]

1 and 2 are cross-sectional views showing embodiments of a balloon catheter according to the present invention. The figure shows a tube body made of vinyl chloride resin with a hardened silicone rubber adhesive layer (=catheter with a silicone rubber balloon attached). Also, Figure 3 is a cross-sectional view showing a comparative example, which is based on a conventional combination of different materials. In the figure, 1 is the tube body, 1a is the tube body (vinyl chloride resin), 2 is the anchor agent coating layer, 3 is the adhesive hardening layer (addition polymerization type silicone rubber), 4 is the balloon, and 4a is the balloon catheter. Balloon (silicone rubber); 5 is the bonded part between the balloon and the tube body (silicone composition in the example); 5a is the bonded part 6 is the balloon inflation fluid passageway between the balloon and the tube body; 7 is the balloon inflation fluid passage; 8 is the inner lumen of the tube body, 9 is a thread for fixing the balloon. Patent applicant: Sumitomo Bakelite Co., Ltd. Patent applicant: Fuji Systems Co., Ltd. Procedure amendment Obi (spontaneous) February 13, 1980 To the Commissioner of the Japan Patent Office1, ICf'l indication 1982 Patent Application No. 2328092, name of the invention Medical tube with balloon 3, relationship with the amended person case Patent applicant 11' Location: 1-chome Uchisaiwai-cho, Chiyoda-ku, Tokyo @2-2-1
．． The application subject to amendment and the detailed description of the invention in the specification. 5. Contents of amendment (1) Add "(Patent amount N pursuant to the proviso to Article 38 of the Patent Act)" to the upper right corner of the application. (2) Add [2. Number of inventions stated in the claims, 2J] to the column 1. Title of the invention and the column 28 Inventors of the application. [3) M Correct ``Balhoon'' to ``Balloon'' on page 4, line 16 of Book #II. that's all

Claims (2)

[Claims] (1) In a medical tube such as a catheter having one or more balloons, the tube body is made of a soft vinyl chloride resin and the balloon is made of silicone rubber, and the tube body and the balloon are made of an addition-polymerized silicone composition. A medical tube with a balloon, which is characterized by an adhesive cured layer (= an integrated adhesive layer). (2) Medical tubes such as catheters having one or more balloons (1) The tube body is made of soft vinyl chloride resin, the balloon is made of silicone rubber, and the entire inner and outer surfaces of the tube body, or at least the balloon (2) A cured layer of an addition polymerization type silicone composition is provided in advance, and the cured layer and the balloon are bonded together with a condensation type RTV silicone composition or an addition polymerization type silicone composition (=therefore, the adhesive is integrated). A medical tube with a balloon.