JPS5850965A - Resin composition for medical device - 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 The present invention relates to a resin composition suitable for constructing medical equipment, particularly a ring wave storage bag, a blood storage container, and a tape ring for a blood circuit of an artificial kidney.

BACKGROUND ART Conventionally, blood bags have been used as medical equipment for transporting and storing blood, and blood circuit chains and KIILs have been used to perform dialysis using an artificial kidney for patients suffering from kidney disease.

The desired properties of these substances are that they must be flexible and not change in quality, and even if they come into contact with blood for a long time, they must not change the quality of the blood or transfer foreign substances into the blood.

In addition, the blood duct tube has transparency that allows the blood passing inside to be observed from the outside, flexibility that allows it to be shaped into its own shape, and a liK tube that can be tightened and removed from the outside of the chain with a kukunpu. The rebound elasticity allows the blood flow to be stopped or flowed at any time by this operation, and the chance of adhesion of sK chain comrades that are stacked (wrapped with chain) is 1%. h@
A non-adhesive surface is required.

Conventionally, blood bags and tubes for blood circuits have been made from compositions made by adding a large amount of dioctyl tsthalate to vinyl chloride resin. Although this composition has excellent flexibility and transparency, the disadvantage is that a small amount of dioctyl 7-talate is eluted, absorbed into the body through the blood, and accumulated. In addition, blood duct tapes are sometimes brought into contact with ethylene oxide gas for sterilization, but in such cases, the ethylene oxide absorbing property is also considered to be a drawback.

Therefore, it is necessary to create a blood bag that does not have such drawbacks, and an O#1 fat assembly for blood circuit Chague configuration.

The inventor has rumored that the above-mentioned vinyl chloride resin containing dioctyl 7-talate is already in practical use because it does not have the drawbacks of dioctyl, and is based on the test standards specified in the Japanese Pharmacopoeia and the Ministry of Health and Welfare notification.
1. Focusing on the fact that it passed IK, we improved the vinyl chloride resin and tried to solve the above drawback by creating a resin composition that does not use dioctyl 7 tallate. As a method to soften vinyl chloride resin without
It was discovered that vinyl acetate A10 terpolymer is effective.

However, due to the ternary copolymer of ethylene, carbon oxide, and vinyl acetate, it causes adhesiveness on both surfaces.As a result of further intensive studies, we decided to incorporate a specific bisamide compound. From K! ! They discovered that it was possible to reduce the stickiness of strawberries, leading to the completion of the present invention.

The gist of the present invention is as follows: (1) vinyl chloride resin, (lyethylene/carbon oxide/vinyl acetate copolymer); is an alkyl group or alkenyl group whose type is s or more and 9 or less)'!: represented by I!, which is present in a resin composition for iron equipment containing a bisamide-based compound.Next, regarding the resin composition for medical equipment of the present invention, This will be explained in more detail.

The vinyl chloride resin used in the present invention may be not only a vinyl chloride homopolymer K11l but also a vinyl chloride copolymer. Examples of vinyl chloride copolymers include copolymers obtained by copolymerizing vinyl chloride with other monomers, as well as copolymers obtained by graft polymerizing vinyl chloride onto other polymers or copolymers. Polymers can also be used.

Other monomers mentioned above include α-olefins such as ethylene and propylene, vinyl esters such as vinyl acetate and vinyl stearate, vinyl ethers such as methyl vinyl ether and cetyl vinyl ether, vinyl bromide, vinyl fluoride, etc. Examples include vinyl halides, unsaturated acids such as maleic acid, maleic anhydride, and tumaric acid, and esters thereof, styrene, acrylonitrile, and vinylidene chloride. Examples of the polymer or copolymer serving as the backbone of the graft copolymer include chlorinated polyethylene, ethylene-W# dinylic acid copolymer, and ethyl V-1-pyrene copolymer. Furthermore, chlorinated vinyl chloride resin obtained by post-chlorination of vinyl chloride resin can also be used.
Vinyl co-heavy metal is, for example, manufactured by Nibon Co., Ltd.
41J41 is commercially available, and these can be copolymerized with 13 to aS weight 110-carbon oxide and a1 to 11 (L, weight part O11 vinyl oxide) to 1 weight lIO ethyl V. Ethylene - Carbon oxide **Vinyl Copolymer Co., Ltd. Chlorinated beer-based -9i110/Weight sK to S
It is preferable to use the weight part OII apricot to TomiOO,
Excellent flexibility, transparency, and properties can be obtained as a resin assembly for medical materials.

However, in the case of a composition made of vinyl chloride resin and ethylene 1-carbon oxide.
11L tends to stick together at mutual corners, which is the so-called AM tackiness, and the surface tackiness is reduced by containing a specific bisamide compound.

The bisamide compound used in the present invention is represented by the general formula (where n is a number from 1 to 180!1, and R and R' are an alkyl group or alkenyl group having 8 to 29 carbon atoms). It is something. Those in which R and R' are alkyl groups include, for example, methicindiamine silicylate,
Ethylene diamine distearate, ethylene diamine dicrate, ethylene diamine dicrate, tetramethylene diamine silacrate, hexamethylene diamine silacrate, methylene diamine lumitate, ethylene diamine di/1 lumitate, tetraphthylene diamine di-1 lumitate, hexamethylene diamine di-1 lumitate - lumitate, methylene diamine distearate, ethylene diamine distearate, tetocumethine diamine distearate 1
At least one of hexamethylene diamine is 1.
Examples of compounds containing a Lequeel group include methylene diamine dicune decylelate, ethylene diamine dicune decylelate, tetramethylene diamine dicune decylelate, hexamethylene diamine dicune decyleate, methylene diamine dioleate), ethylene diamine dioleate, and F-ramethylene diamine dioleate, ^-life methylene diamine dioleate, methicine diamine silicylate,
Examples include ethylene diamine dilysyl ester, temethylene diamine dilysyl ester), xamethylene diamine dilysinodieate, hexamethylene diamine lysyl ester, hexamethylene diamine lysyl ester, hexamethylene diamine lysyl oleate, and oleate. Among the above compounds, stearic acid ξ is particularly preferably used, such as methylene diamine distearate, ethylene diamine distearate, tetotsuno ethylene diamine distearate, and hex methylene diamine. It is distearate. The melting points of these ste and aric acid amide compounds are 130°C and 140°C.
It is obtained as a white powder.

To 100 parts by weight of the composition consisting of vinyl chloride resin and ethylene-carbon oxide/vinyl acetate copolymer prepared by Bisamide Compound Co., Ltd., (LX to 5 parts by weight) is added. suitable.

That Bisua! When used alone, the ide-based compound exhibits a sufficient effect of suppressing surface tackiness, but it can also be used in combination with other substances that have auxiliary properties. Isa Bisua! The material used in combination with the compound is low molecular weight polyethylene (xF average electrical distribution 1000
~6000).

A hemolytic compound obtained by containing a resin mixture consisting of a clear chlorinated beer-based resin, an ethylene φ-oxygenated vinyl acetate copolymer, and the above-mentioned Bisya F Thickening Shamono. The composition Kl has favorable properties as a composition for composing the 11111a material.
The above-mentioned hypersensitivity and cell susceptibility are completely suppressed by adding chlorinated Magne V-cum-chopper and Fi (and) II-chloride Calcicum-mildew powder. Magnesicum oxide mold train, Cal oxide S/? In terms of characteristics, it is desirable that all particles have a particle size smaller than that of SO particles.

Oxidation! Calcicum oxidation powder % calcium oxide mold viewing! Mori, Isa Vinyl chloride resin and ethylene-monoxide element **
Vinyl copolymer, 01 to 2 parts by weight based on 1 part by weight of the above-mentioned bisama compound composition
Preferably, it is added in a ratio of 10.

In order to improve the quality and aging resistance of the composition of the present invention, conventionally known stabilizers and plasticizers are added to the extent that they do not have a harmful effect on the composition. It can be blended into the composition.

Examples of the stabilizer include calcium stearate, zinc stearate, baricum stearate, etc., and as the plasticizer, epoxidized soybean oil, dioctyl tstalate, etc. can be used.

As described above, the medical resin composition of the present invention comprises a vinyl chloride resin, an ethylene-carbon oxide/vinyl acetate copolymer,
Since it contains the bisamide-based compound,
The medical equipment obtained from K has excellent flexibility and transparency, and not only does not exhibit hemolysis or cytotoxicity, but also has significantly suppressed surface tackiness caused by the ethylene-carbon oxide/vinyl acetate copolymer. When medical equipment is left stacked for a long time, adhesion between the equipment does not occur at all.

Zero-release #4@Resin composition for medical equipment can be suitably used for molding of medical equipment such as medical catheters, tubes for blood transfusions and infusions, blood bags, infusion bags, and blood pumps for artificial dialysis. can.

Examples of the present invention are listed below. The meltability test was carried out in accordance with the Plastic Container Test for Infusions* in the Japanese Prefecture's Test Guide. parts, 60 parts by weight of ethylene-carbon oxide @ vinyl acetate copolymer (ethylene copolymerization component [1% by weight, -carbon oxide copolymerization component 10% by weight), parts by weight of methylene diamine disthialate honey, magnesium oxide 6 parts by weight of A, 7 parts by weight of Cm-Zm stabilizer A, and 7 parts by weight of epoxidized soybean oil were placed in two rows and kneaded at 140°C to obtain a roll sheet.

Next, this was press-molded for 3 minutes at a temperature of 150°C and a pressure of zoom/- to form a flat, smooth sheet with a thickness of ab-. When this sheet was subjected to a hemolytic test, it showed no hemolytic effect at all. Next, a surface adhesion test was conducted. For the surface adhesion test, the above sheet was cut into rectangular test pieces with a width of 2 mm and a length of t113-, two of these were stacked on top of each other, and a 500 f/min was uniformly applied to the area up to 61 from one end of the test piece. The sample was left at 50℃ for 24 hours under a load of 12-1, and was allowed to blow up.
This was done by separating the film at a tensile rate of oz/min and determining the maximum peeling force. As a result, the maximum peel force is 3
5t/j! am, and the maximum peeling force without using methylene diamine distearate parts by weight is 210 f
It was observed that the surface tackiness was significantly longer than that of /2a.

Examples 2-3 In Example 1, methylene Schiff truncated disthialate Q
Example 1 except that instead of 7 parts by weight, 7 parts by weight of ethylene di7mine disthialate II' (Example 2) and 7 parts by weight of 7 parts by weight of ethylene di7mine disthialate q (1111 parts by weight of Example 3) were used. Form the sheet completely uniformly 1
Next, an occult blood test and a surface adhesion test were conducted.

As a result, he had no intention of eventually changing his status to 4.

Also, the maximum peeling force is! IRy/J- (implementation@:), 13f
! ／鵞- (Implementation @ 3), and the maximum surface adhesion is smaller than the maximum force of 21°11/2 when ethylene diester or hexane methylene diester is not used. It was observed that the amount of fusion was reduced.

Example 4 In Example 1, vinyl chloride # (m/ft) was used.

50) A sheet was formed in the same manner as in Example 1, except that 100 parts by weight of vinyl chloride-ethylene copolymer (degree of polymerization SOO, ethylene copolymerization amount 4 weight*) was used instead of the 10031 filter part. Then, a hemolytic test and a surface adhesion test were conducted. As a result, it showed no hemolytic properties. In addition, the maximum peeling force is 47 F/2 tar, which is smaller than the maximum peeling force zsop/2 when methylene diamine distearate (17 parts by weight) is not used, and the surface tackiness is significantly reduced. was recognized as doing so.

Examples 5-6 Methylenediamine distearate) (L
77 instead of 1 ton of ethylene distearate (
A sheet was molded in exactly the same manner as in Example 4, except that L71 member (Example 5) and hexamethylene diamine distearate honey layer (Example 6) were used, and then a hemolytic test and a surface adhesion test were performed. A sex test was conducted.

As a result, none of them showed significant hemolytic properties.

Also, the maximum peeling force is 38 f/'! l am (Example 5), 15f/2 country (Example 6), and the maximum peeling force was 250 tp/2 when ethylene diamine distearate and hexamethylene diamine distearate were not used.
It was observed that the surface tackiness was significantly lower than that of (2).

Patent applicant Sekisui Chemical Co., Ltd. Representative Toshinori Fujinuma 111f+'i'!・: l', ''A'':, ('
, 'L-style company speaking' to JF Moon (representative patent attorney Hiroshi Onishi

Claims (1)

[Scope of Claims] L (A vinyl chloride resin, (b) ethylene/carbon oxide/vinyl acetate copolymer, (however, in the formula, n Fil to 151o1 is a number, R, R
A resin composition for medical equipment containing a bisamide-based compound represented by an alkyl group or 1-alkenyl group having 8 or more carbon atoms and 29 or less carbon atoms. Resin composition milk for medical equipment according to claim 1, characterized in that: ζ containing calcium oxide mold powder or (and) magnesium oxide fine powder; Range I11
Is for medical equipment of Section 2 of Section 2 of Section 2 in Section 2! IiI composition