JPS58157469A - 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 tree binding device suitable for constructing medical equipment, a 411K ring housing storage pad, a blood storage container, an artificial kidney tract chain, and the like.

BACKGROUND ART Conventionally, blood bags have been used as medical equipment, for example, to transport and store blood, and blood circuit tubes have been used when performing dialysis using an artificial kidney for patients with renal failure.

The required properties of these KIIs 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 blood or transfer foreign substances into the blood.
In addition, the blood 11i tract tape allows you to observe the blood passing inside from the outside! 1. Flexible enough to be freely deformed, tightened by tightening from the outside of the chain (round)
When the tube is shielded, the tube returns to its original O shadow shape, and by this operation, the blood flow can be stopped at any time. In addition, a non-adhesive surface is required to prevent the tubes from adhering to each other.

Conventionally, diotatylphthalate (hereinafter referred to as DOP) is added as a detergent to vinyl chloride resin, and from the nine compositions, for example, blood 1 [0] is collected, a rounded liquid bag for preservation, a rounded liquid bag for artificial dialysis, etc. Medical equipment such as circuit tapes can be molded.

However, in the case of compositions containing vinyl chloride resin KDOP, there is a concern that DOP will be released into the blood chamber and have an adverse effect on the human body. 411 to eliminate the shortcomings of this umbrella.
1154-11@I@i1 (JP-A-185@-41!4
No. 0), a copolymer is added to vinyl chloride resin, ethylene-carbon oxide, vinyl acetate, and calcium oxide or oxidation! Arrange a predetermined amount of Gnesicum 01111 and propose a resin composition for medical equipment. If acetic acid is present), ζoIIll fat composition is used to mold medical equipment, causing bloodletting and cytotoxicity.
It turns out that if the amount of vinegar generated is extremely small, use calcium oxide or madanesium oxide in silver oxide as a final precaution! Although it is possible to capture IIIO, the amount of O in the composition is large and O
Lucium oxide 'II! The ore cannot be completely captured by the magnesium oxide aSS powder.
Avoid cytotoxicity. Calcium oxide or oxidation in the composition to scavenge acetic acid! If the amount of Gunesicum O mold powder is increased, the Ichomonosha transparency am will decrease, the residual amount of ignition will increase, and there is a possibility that the standard value for medical equipment will be exceeded.

In view of these points, the present invention was made as a result of further unique studies. In the group IIL substance for which coalescence is investigated, as an ethylene-carbon oxide-vinyl acetate copolymer, it has no solubility in ethylene-e-carbon oxide-vinyl acetate copolymer and is soluble in acetic acid. The present invention relates to a resin composition for medical equipment, which is characterized in that it is preliminarily coated with a certain liquid.

Next, the resin composition for medical equipment of the present invention will be explained in more detail.

The vinyl chloride resin used in the present invention is vinyl chloride O
The I# monopolymer may be a vinyl chloride O copolymer. Vinyl chloride O copolymers include II round copolymer O obtained by copolymerizing vinyl chloride and a monomer of Rin, and vinyl chloride obtained by copolymerizing vinyl chloride with a working O polymer or copolymer. Graft polymers can also be used. Examples of the above-mentioned monomers include Oα-
Olefin a, sa vinyl esters, stearin vinyl esters, vinyl ethers such as methyl vinyl ether, dragon chill vinyl ether, vinyl bromide, vinyl fluoride, iv iron, maleic anhydride, etc. , fumaric acid, 111IO unsaturated acid-1l and their O esters, styrene, atarynitrile, and vinylidene chloride can be mentioned. Examples of the polymer include chlorinated polyethylene, ethylene-vinyl acetate copolymer, and ethylene-bupylene copolymer. Furthermore, it is obtained by post-chlorinating vinyl chloride resin, and chlorinated vinyl chloride ll1l1
1- Can be used for stool.

However, vinyl chloride resin lacks flexibility as a molded product, and it is not suitable for medical molded products that require flexibility, such as blood bags and blood circuit tapes. do not have. In order to impart this rounding flexibility, it has been attempted to add a dioctyl 7-talate type stabilizer, but toxicity due to elution of the binder poses a major problem.

Therefore, in the present invention, we have added an ethylene-carbon oxide-vinyl acetate copolymer to the 10 round shape that can impart flexibility to molded products and maintain a high degree of transparency without adding a binder. Distribute meals. The ethylene/carbon oxide/vinyl acetate copolymer used in the present invention is, for example, manufactured by DuPont Co. [Elvaloy 741J is commercially available; O is a copolymer of 0.5 to 0.5 parts by weight of carbon monoxide and 0.1 to 0.9 parts by weight of vinyl acetate. Ethylene-Carbon Oxide-Vinyl Acetate Copolymer Co., Ltd. 5 to 100 parts by weight of pynylic chloride resin! It is preferable to use it at 0.111 parts by weight.However, it often contains acetic acid produced (by decomposition of Ka in the ethylene-carbon oxide-vinyl acetate copolymer), When a molded article is molded using a composition blended with a vinyl chloride resin, vinyl acetate is present in the molded article and becomes a causative agent of hemolysis and cytotoxicity*).
[There is a risk of losing O suitability for use in steam equipment.

By the way, if calcium oxide powder or magnesium oxide mold powder is contained in the molded product, the amount of acetic acid is increased by capturing acetic acid. However, the amount of acetic acid is
/ Oxidation at the end of the 9th trial! If the J11 capture ability is exceeded in the end, there is a possibility that the J11 capture capacity will be exceeded.
11ml exhibits toxicity and is suitable for use in Osaka therapy equipment.
I'm 40. Calcium oxide mold treatment is used as a countermeasure against this disease.
It may be possible to increase the amount of mold ring powder O in Magne oxide V9, but in this case, the molded product's ears will decrease, and the ignition temperature will also be higher than the regulation value in medical IH1. Therefore, it is not appropriate to use a large amount of calcium oxide fine powder or i-gnesicum oxide fine powder O.

Therefore, in the present invention, the ethylene-carbon monoxide-vinyl acetate copolymer is pre-prepared with a liquid that is insoluble in the ethylene-carbon oxide-vinyl acetate copolymer but soluble in acetic acid. We use round ones that have undergone a tightening process.

Although water is suitable as the liquid, the following liquids may be used alone or in combination.

Alcohols: methanol, ethanol, a-propyl alcohol, alcohol, ethanol, acetone, methyl isobutyl ketone, methyl ethyl ketone esters; ethyl acetate, butyl acetate; butane, be/thane, hexano, / Chlohequinane, benzene, middle silane, toluene, tetragenated water bulk system; vinyl chloride, 7-leon, chloroform, carbon tetrachloride, trichlene, dionene, dimethylformamide, sesolv, etc. and 011! Alternatively, the copolymer may be pulverized in granular form and immersed in the casing using a sieve, or the casing may be diluted with water or dispersed in water.
It is preferable to immerse the liquid in water at 0.

The contact temperature between the copolymer and the casing is adjusted to a temperature range lower than the second order transition temperature of the member polymer, so O is preferable), and the contact time is several minutes. O is considered to be Jito S*
is suitable.

By bringing the copolymer into contact with the liquid, the vinyl acetate present in the molded article is washed out. During the copolymerization, vinyl acetate, which is present in the body, is released, resulting in cytotoxicity.

After thorough washing, we actually molded the composite material to determine whether it was round or not, and conducted a hemolytic test on the shape. ! Although it can be determined by carrying out a durability test, the approximate I-animal value can be determined from the PH value by measuring the washed IfOPH value and correlating this with the hemolysis test and cytotoxicity test.

After repeated washing, electric drying is performed, and thermal treatment and vacuum drying treatment are applied to ensure that organic solvents and the like do not remain.

A composition consisting of a vinyl chloride resin and an ethylene-oxycarbonated bulk vinegar vinyl-membered heavy metal body has desirable properties as a composition for medical S materials in terms of flexibility and transparency. However, the composition is further refined by magnesium oxide mold powder (and)
By containing calcium oxide image powder, the above-mentioned hemolysis and cytotoxicity are suppressed.

In this case, it is desirable that the fine powder of Madanea 9um oxide and the fine powder of calcium oxide have an OSm of 450 or less.

Magnesium oxide mold powder, oxidized Rutata mold powder, 100 parts by weight of vinyl chloride resin, 00051 to 5
It is desirable to add it in a weight ratio.

Furthermore, in order to improve the stability and aging resistance of the composition contained in the present WA, the stabilizing agent was added to the armpit in a range that would have a negative effect on the blood. It is possible to mix it into the ingredients.

As the stabilizer, for example, calcium stearate, stear V/zinc, and pacium stearate can be used, and as the stabilizing agent, V-containing soybean oil in EPO and diotatilucrate can be used.

The composition of the present invention contains the above-mentioned nine vinyl chloride resins and seven ethylene-oxidized vinyl copolymers, and these copolymers are soluble in the Chen Gong polymer. Not soluble in acetic acid! ! The acetic acid present in the axillary copolymer body can be removed by using a liquid containing an electrolyte (by using an electrolytic layer 10), and the wrinkled copolymer body This makes it possible to avoid hemolysis and cytotoxicity caused by medium-O acetic acid.

In the present invention, the thus obtained composition is used to mold a molded article into a desired shape. The shape of the molded product may be a film, sheet, plate, container, tube, tube, rod, bag, or any other O shape, and the shape is suitable for the intended medical device ItO.
111 IIK is accused of kenpo. Molding includes extrusion molding, injection molding, #l grinding molding, press molding, blowing engraving, etc.
Adoption of L-shaped means increases the speed.

It is preferable that the silver wrinkles during molding be 110°C to 111G'C1i degrees.
It is most preferable to form the carbon oxide/vinyl acetate copolymer O into a round shape at a temperature range of 110° C. to 140° C. to suppress thermal decomposition.

The thus obtained molded product for medical equipment is suitable for use as it is or by secondary processing), catheters, blood transfusions, C) f-Eso, blood transfusion bags, and other medical devices. It is something that can be done.

According to the molded article for medical equipment obtained by the method of the present invention,
Excellent flexibility and permeability, shows no hemolysis or cytotoxicity,
In addition, the resistance to dirt in boots can be improved and medical equipment can be obtained.Examples of the present invention are listed below. 1 to shi,
- The blood test was conducted in accordance with the Japanese *Pharmacopoeia ``General Test Shibu J4C1 * Test method for O plastic containers for O-wheeled cabinets''.
Using 3.0 parts by weight of water to 0.00 parts by weight, heat in a container with a stirrer at mold temperature for 60 minutes.

Next, it was dehydrated and dried, and the pH value was measured based on the ring moat plastic S instrument test method, and the pH value was IL5.

On the other hand, in the above O washing, the amount of O spilled out into the water is expressed as L1 weight for the Kojiki copolymer.

Next, use the ethylene/carbon 11 vinyl polymer and the polymer to obtain the following composition.

Magnenium oxide Q, 5 parts by weight Calcium/zinc stabilizer 16 parts by weight Epoxidized soybean oil 2.0 parts by weight The above composition was kneaded using an extruder to form pellets.

Next, a sheet molding machine was used to obtain an F-shaped molded product with a thickness of 0.3 cm. This sheet-like material has excellent transparency and flexibility, has a hemolytic property of 1 to 30%, and does not exhibit cytotoxicity. Show the O value within.

In addition, the boot scratch/dust resistance was also good.This sheet-like molded product 1 was suitable as a sheet for Komo bag.

Example 2 Tree-like ethylene-carbon oxide-vinyl acetate co-merge 1
00 parts by weight, 200 mm parts of methanol was stirred for 60 minutes at the mold temperature in a container with a stirrer, and dried shimo
K was measured based on the ring moat plastic snack container test method, and the amount of eluate O at 9 PHa pot O was 10
Weight - can be.

A similar product to that of Example 1 was produced using ethylene/carbon oxide/vinyl acetate copolymer, and a sheet-shaped molded product was obtained in the same manner as in Example 1. This sheet-like molded product has excellent transparency and flexibility, does not exhibit hemolysis or cytotoxicity, and has a residue on ignition of Q, and exhibits a standard O value of 4 by weight. . It also has good blocking resistance and is suitable for use as a sheet-like molded sheet for blood badgers.

Example 3 Powdered O etele/-carbon oxide/**vinyl member polymer 1
00 parts by weight, 20 parts by weight of books, 11 parts of vinyl chloride, stirred for 60 minutes at 25°C in a stirrer equipped with a **0, and tested the plastic container for a ring moat for dry Chiemo O. Using this ethylene-carbon oxide-vinyl acetate copolymer in the 90-method, the amount of eluate O at a constant PH & i@Ll was set at 1 ml of the above copolymer KmIL.
The same composition as in Example 1 was used and a sheet-shaped molded product was obtained in the same manner as in Example 1. This sheet-like molded product has transparency,
Turtles have excellent flexibility, #I storm properties, and cytotoxicity.
Also, the ignition residue exceeds the O value within the blood set standard at Q, 4 weight - 0, and the blocking resistance is also good.

This sheet-like molded product is suitable as a blood bag sheet.

Example 4 Powdered ethylene-carbon oxide-vinyl acetate copolymer 1
00 parts by weight, 200 parts by weight of water, 10 parts by weight of acetone, and 60°C at 25°C in a container O with a stirrer.
Stir for 1 minute, then measure the dry raw material K based on the test method for a rotary container.The 9PH is L8, and the amount of eluate O is a% by weight based on the copolymer. A composition similar to that of Example 1 was prepared using a dichloromethane-vinyl acetate co-N, and a sheet-like molded product was obtained by adding 11K to Example 1. Flexibility of sheet-shaped molded product,
It has excellent flexibility and does not exhibit hemolytic or cytotoxic properties.
The ignition residue also shows a value of 0.4 weight - within the blood moat set layer base. The scratch resistance was also good.

This O sheet-like molded product is suitable as a sheet for the imperial cabinet badder. Example 5 Granular O ethylene/carbon oxide/vinyl acetate copolymer 10
0 parts by weight, ice and snow...parts by weight, vinyl chloride S]ll
[60°C at 40°C in **0 with a stirrer using a warm moat
Stir for 11 liters, then adjust to 9% OK based on the test results for ring moat plastics.
The amount of output O is the copolymer KILL! Jall-de 1
IIl! Next, prepare the same relative as in Example 1 by using this ethylene/carbon oxide 11 vinyl copolymer, and obtain a sheet-like molded product in the same manner as in Example 1. ζO receipt molded product has excellent transparency, flexibility, bloodletting properties, and
It did not show Il toxicity, and the ignition residue was 0.4% by weight, which was less than 7J. It also has good blocking resistance.

This notebook-shaped molded product is suitable for use as blood powder.

Comparative Example 1 Calcium/zinc stabilizer 1.5 parts by weight Epoxidized soybean oil 10 parts by weight A sheet-shaped molded product was obtained from the above composition in the same manner as in Example 1.

Claims (1)

[Claims] 1. A composition containing a vinyl chloride resin and an ethylene-carbon oxide-vinyl acetate copolymer;
- As a carbon oxide/vinyl acetate copolymer, ethylene e-
A liquid that is not degradable to oxidized carbon/vinyl acetate copolymer and monolytic to acetic acid) is pre-layered.
Patent claim O 11, characterized in that the composition contains calcium oxide mold powder or (and) Madaneshicum oxide mold powder. Described Oli method for making Oli majestic carvings for medical equipment