JPS5997670A - Medical bag - 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 medical bag for containing blood, medical solutions, etc., which has excellent hygiene, flexibility, transparency, heat resistance, etc.

Currently, as medical containers, hard containers made of glass, polyethylene, polypropylene, etc., and soft bags made of polyvinyl chloride containing a plasticizer are known. However, in the former case, air must be introduced into the tube into which the liquid is dripped using a vent needle or an infusion set with a vent hole, which is unhygienic and dangerous as it not only causes contamination but also air entering the vein and causing an air blockage. In the latter case, the introduction of air is not necessary, and the bag itself is squeezed by atmospheric pressure as the contents drop.
At the end of the infusion, the liquid content remains at the bottom, so air inside the bag does not get mixed into the patient's body, and rapid infusion is possible by pressurization.In addition, it is not bulky like a container, making it convenient to transport. Although the number of plasticizers is increasing, the transfer of the plasticizer to the content liquid,
Problems such as the toxicity of the vinyl chloride monomer contained in polyvinyl chloride remain.

The present invention was arrived at as a result of various studies to solve these problems, and is based on a laminate that is highly hygienic, highly flexible, transparent, and has heat resistance corresponding to the humidity of sterilization. The present invention provides a medical bag consisting of a laminate in which the inner and outer layers are made of low-density polyethylene, and the middle layer is made of a composition of ethylene-vinyl acetate copolymer and ethylene-propylene-based elastomer or ethylene-butene-1-based elastomer. This is a unique medical bag.

The low-density polyethylene of the inner and outer layers of the laminate that makes up the medical bag of the present invention has a density of 0.930 g/i or less, has far better hygiene than polyvinyl chloride, and has good flexibility and transparency. However, due to the sterilization temperature conditions, the density was 0.920.
! i'/cff1 or more is preferable. Note that the low density polyethylene may be modified or mixed with different resins, fillers, additives, etc. as long as the above characteristics are not adversely affected in practice.

The intermediate layer of the laminate of the present invention is made of a composition of an ethylene vinyl acetate copolymer and an ethylene propylene elastomer or an ethylene butene-1 elastomer, and the ratio thereof is not particularly limited. Combined 1-99% ethylene propylene elastomer or 1,000-butene-1 elastomer 99-1% by weight
Preferably it is outside the upper frame. If the ethylene vinyl acetate copolymer content is less than 1% by weight, moldability will be reduced, and if it exceeds 99% by weight, flexibility will be insufficient. From the viewpoint of moldability, the ethylene vinyl acetate copolymer is preferably 30 to 90% by weight.

In particular, when manufacturing the original fabric of the medical bag of the present invention by coextrusion molding, the use of ethylene propylene elastomer or ethylene-butene elastomer alone as the intermediate layer is usually more amorphous than when using a crystalline polymer. Due to its high properties, it is difficult to mold with ordinary molding materials.In order to improve this moldability, a method is adopted in which ethylene-vinyl acetate copolymer is mixed in the above-mentioned ratio.

In this case, in order to obtain transparency of the laminate, it is preferable that the melt flow rate of the intermediate layer composition and the melt flow rate of the low density polyethylene used for the inner and outer layers be as close as possible. If the melt flow rates between the two are extremely different, turbulence will occur in the flow of the melt at the point where the intermediate layer and the inner and outer layers meet, making it impossible to obtain the required transparency. The melt flow rate of the composition used for the intermediate layer can be estimated relatively accurately by calculation if the melt 70-rate of the component is known in advance, so each component suitable for molding,
You can choose the ratio.

In addition, the ethylene vinyl acetate copolymer, ethylene propylene elastomer, or ethylene butene-1 elastomer used for the intermediate layer of the laminate has excellent not only transparency but also particularly flexibility, and the low-density polyethylene copolymer used for the inner and outer layers of the laminate. has adhesive properties.

In order to exhibit flexibility, the vinyl acetate content of the ethylene-vinyl acetate copolymer is 10% by weight or more, the brohylene content of the ethylene-propylene elastomer is 60 mol% or less, and the butene-1 of the ethylene-butene-1 elastomer. The content is preferably 5 mol% or more, and the ethylene vinyl acetate copolymer, ethylene propylene elastomer, or ethylene butene-1 elastomer may be modified, filled with different resins, or filled with other resins, within a range that does not practically impede the above properties. Materials, additives, etc. may be mixed.

The thickness of the laminate is preferably 0.15 to 0.6 mm, and if it is less than 0.15 mm, the sense of mass will be impaired and the thickness will be 0.6 mm.
If it exceeds this, there will be a lack of flexibility. Although the thickness ratio of each layer is not particularly limited, in order to impart sufficient flexibility to the laminate, the thickness of the intermediate layer is preferably 60% or more of the thickness of the laminate, and the thickness of the inner and outer layers is 0. , when the thickness is 1 mm or more, the flexibility of the laminate tends to be insufficient, and when the inner layer thickness is 0.0
If it is less than 1 iz, there is a concern that the heat sealing strength will be weakened. The flexibility of the laminate can be expressed as an elastic modulus of 600kl using a taper stiffness meter in accordance with ASTM D747. /ffl or less preferably 500kg/ff
l or less.

To obtain the laminate number, water-cooled or air-cooled coextrusion inflation method, coextrusion T-die method, dry lamination method,
Although an extrusion lamination method can be employed, water-cooled coextrusion inflation method and coextrusion T-die method are preferred from the viewpoint of performance, especially transparency and economy. The laminate is usually in the form of a tube or sheet, and is heat-sealed to form a bag into a predetermined shape and size, and an attachment for feeding and discharging is attached.

If necessary, the medical bag thus obtained is washed with distilled water, sterilized water, etc. at a predetermined temperature on the inner and outer surfaces of the bag before being filled with the liquid content, dried, and then filled with the liquid content.

Next, sterilization is performed, and examples of this method include a method using high-pressure steam, and the conditions for high-pressure steam sterilization are not particularly limited, but usually 115°C x 30 cylinders, 12
For example, 1°C x 20 minutes.

However, if the medical bag of the present invention is subjected to the sterilization treatment in a free state, wrinkles will occur near the sealing part and the appearance will be somewhat impaired. It has been found that the sterilization treatment can be carried out by stacking and fixing the bags with their top and bottom ends and/or left and right ends fixed, or by pressurizing and fixing the center part of the bags with an object.

Furthermore, after sterilization, at least 10 m1 at 40℃ or higher
It has also been found that the transparency of the bag is improved by heat treatment of n. Note that if it is less than 40°C, the processing time becomes long and there is a problem in economical efficiency, and if it is less than 10 mm, the improvement in transparency is insufficient.

It has heat resistance and heat sealing properties that are more hygienic and suitable for sterilization processing, and the middle layer has flexibility and adhesiveness with the inner and outer layers, making it a conventional material while retaining the characteristics of conventional soft bags. This has the effect of solving problems such as migration of plasticizer from polyvinyl chloride into the content liquid and toxicity of vinyl chloride monomer.

The present invention will be explained in more detail by giving Examples and Comparative Examples below.

Examples 1 to 7, Comparative Examples 1 to 3 Laminated sheets having the synthetic resins and layer configurations shown in Table 1 were fabricated using the water-cooled coextrusion inflation method in Examples 1 to 7 and Comparative Example 1, and T in Comparative Examples 2 and 3. - It was molded by the Gouy method and further evaluated for various properties as a medical bag with an internal volume of 500 cc.

In addition, LDPE in the table has a density of 0.927 g/7s melt flow rate.
)(,190°G) 1.1,! i'/1 omm
Low-density polyethylene EVA containing vinyl acetate, fE23 heavy R): %, melt flow rate (190°C) 23 g/10 m1n, ethyrezo-vinyl acetate copolymer EPR is density 0.90011/c++? , Melt 7
0-Leh) (190°C) o, 5 i / 1 om=
The ethylene propylene elastomer EB with a prohylene content of 28 mol% has a density of 0.8901 lcr&, a melt flow rate (190°C) of 3.8 g/l 0
m1n, butene-1 containing N15 mol% ethylene-butene-1 elastomer HDPE has a density of 0.950 fi, /crIt, melt flow rate (190°C) 1-2. ! 9/ln# high-density polyethylene is fixed to 3 bags filled with the liquid content, and the heat resistance is 115 by fixing the upper and lower end seals of the bags after filling the liquid content.
℃><3 (H+m high pressure steam sterilization treatment and further treatment at 40℃ x 1□mm to improve the transparency of the bag. Observation of deformation, bag breakage, and seal leakage. Flexibility. Elastic modulus for elasticity is a value measured by Taper Stiffness 31 in accordance with ASTM D747, spontaneous discharge property is visually observed, transparency is visually observed as specified /A:, and foreign matter is detected after filling with saline and high-pressure steam sterilization. Contamination was visually observed. Transmittance was measured using visible absorption spectrum at 450 mμ. Hygiene was tested based on the Japanese Pharmacopoeia Infusion Plastic Container Test Method. Appearance was visually inspected for wrinkles, deformation, and broken bags. Condition: ◎ is very good, ○ is good, △ is slightly poor, × is poor.

The medical bag of the present invention shows almost good results in various physical properties, but as in Comparative Example 1, when the outer layer is made of high-density polyethylene, the flexibility and transparency are slightly poor, and as in Comparative Example 2, ethylene acetate A single layer of vinyl copolymer has poor heat resistance and appearance, and even a single layer of ethylene propylene elastomer, as in Comparative Example 3, has poor heat resistance and appearance.

Claims (1)

[Claims] 1. A medical bag comprising a laminate having inner and outer layers made of low-density polyethylene and an intermediate layer made of a composition of an ethylene-hinyl acetate copolymer, an ethylene propylene-based elastomer, or an ethylene-butene-1-based elastomer.