JPH1052487A - Member for medical vessel and equipment - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a member, whose adhesive strength is not reduced by high temperature steam sterilization, for a medical vessel and equipment, by bonding a polyvinyl chloride molding to a polypropylene molding with a chlorinated polypropylene. SOLUTION: A polyvinyl chloride molding made by blending a substantially vinyl chloride-based polymer with the number average degree of polymerization of 700-5000 and 5-70wt.% of a plasticizer such as adipic acid-based polyester, epoxidized soybean oil, etc., is bonded to a polypropylene molding consisting of isotactic type or syndiotactic type crystalline polypropylene or crystalline copolymer containing those as the main component. Thus, the adhesive strength is not reduced in high pressure steam sterilization and the product becomes excellent in safety and hygiene.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a member for medical containers and instruments used in the medical fields such as blood and medical fluids.

[0002]

2. Description of the Related Art Plastic containers and instruments used in the medical field, including blood collection, blood transfusion and infusion, are required to have various performances in addition to safety and hygiene. By controlling the amount of plasticizer, the rigidity, flexibility, transparency, heat resistance (sterilization resistance), etc. of polyvinyl chloride can be controlled. Conventionally, bags, tubes, joints, outlets provided in bags, etc. Although it is widely used in the medical field, it may cause problems in disposal treatment and the like, and the shift to a chlorine-free polyolefin-based polymer such as an ethylene-based polymer and a polypropylene-based polymer has been progressing.

[0003] However, polyolefin-based polymers have a narrow range of rigidity, flexibility, transparency, heat resistance and the like, so that at present, it is not possible to cover a region where polyvinyl chloride is used. For example, tubes, joints, outlets, and the like may not have a polyolefin material that can replace polyvinyl chloride, and ultimately must rely on polyvinyl chloride. Therefore, at present, emphasis has been placed on converting polyolefin into members that can be converted into polyolefin as much as possible, and reducing parts made of polyvinyl chloride as much as possible.

In this case, the problem is the joining of polymer molded articles (members) having poor affinity. That is, since polyvinyl chloride and polyolefin cannot usually be bonded or fused, their development is greatly restricted. A configuration in which an adhesive polymer in which a carboxyl group or an epoxy group is introduced into polyethylene or polypropylene is interposed between a polyvinyl chloride member and a polyolefin member has been proposed, but in reality, it does not exhibit a sufficient adhesive effect. is there.

[0005]

In view of the above problems, the present invention integrates (adheses) a molded article made of polypropylene and a molded article made of polyvinyl chloride in polyolefin.
To provide a medical container / instrument member.

[0006]

SUMMARY OF THE INVENTION The present invention is a medical container / tool member in which a polyvinyl chloride-based molded article and a polypropylene-based molded article are adhered to each other via a chlorinated polypropylene. It has a good affinity for both the polyvinyl chloride-based molded article and the polypropylene-based molded article, and the adhesive strength is maintained even in the high-pressure steam sterilization treatment usually performed in the medical field, and the safety is maintained. It is also characterized by excellent hygiene.

[0007]

BEST MODE FOR CARRYING OUT THE INVENTION Chlorinated polypropylene (hereinafter referred to as Cl-PP) in the present invention is obtained by chlorinating polypropylene by a generally known method, and is classified into isotactic polypropylene and syndiotactic polypropylene. Examples include chlorinated tic polypropylene and atactic polypropylene, but isotactic ones are generally used. In consideration of the adhesiveness between a polyvinyl chloride (hereinafter, referred to as PVC) -based molded article and a polypropylene (hereinafter, referred to as PP) -based molded article, which is the gist of the present invention, the chlorine amount of Cl-PP is 15 to 50% by weight. % Is preferred. In general, the greater the chlorine content, the better the adhesion to the PVC-based molded article, and the smaller the area, the more excellent the adhesion to the PP-based molded article. Although the amount of chlorine in Cl-PP can be appropriately adjusted depending on the type, properties, etc. of the PVC-based or PP-based molded product, a chlorine content of 20 to 40% by weight is a more preferable range. Further, there is a solution viscosity as an index indicating characteristics such as a molecular weight and a molecular weight distribution of Cl-PP, but in the present invention, a toluene solution (Cl-PP concentration of 10% by weight)
A viscosity at 25 ° C. of 50 to 500 centipoise, more preferably 100 to 400 centipoise, is suitable from the viewpoint of adhesive strength.

[0008] In the present invention, the PVC molded article is a vinyl chloride-based polymer having a number average degree of polymerization of 700 to 5000,
Di-2-ethylhexyl phthalate, di-n-decyl phthalate, tri-2-ethylhexyl trimellitate,
Molded articles containing 5 to 70% by weight of a plasticizer such as di-2-ethylhexyl adipate, di-2-ethylhexyl sebacate, butyryltri-n-hexyl citrate, adipic acid-based polyester, and epoxidized soybean oil are usually used. May be ethylene vinyl acetate copolymer-modified polyvinyl chloride, polyurethane-modified polyvinyl chloride, or cross-linked polyvinyl chloride.

In the present invention, the PP-based molded article is a molded article made of an isotactic or syndiotactic type crystalline polypropylene or a crystalline copolymer containing these as a main component, and PP is its moldability and mechanical properties. Considering such factors as temperature 230 ° C and load 2160
The melt flow rate (MFR) in g is 0.3 to 5
0, more preferably 0.5 to 30. In some cases, other polymers such as polyethylene, polybutene-1, a styrene-based thermoplastic elastomer, an olefin-based thermoplastic elastomer, and the like may be blended according to the performance required for the molded article.

[0010] PVC-based molded products or PP-based molded products are:
Various forms such as a sheet, a film, a bag, a tube, and a joint are formed, and these are usually manufactured by known extrusion molding (inflation, blow, T-die, etc.) or injection molding. The melting temperatures at the time of molding to obtain a PVC molded article and a PP molded article are 140 to 200 ° C. and 1 respectively.
The temperature is preferably 70 to 230 ° C.

The same applies to Cl-PP which plays a role of adhesion, and can be generally formed at a temperature of about 80 to 120 ° C. In some cases, it is dissolved in an organic solvent, for example, toluene, xylene, methyl ethyl ketone, methyl isobutyl ketone, ethyl acetate, butyl acetate, tetrahydrofuran, etc., and provided in the form of a solution to be applied to a PVC molded article or a PP molded article. Is also good. Adhesion temperature is 50-13
The temperature is preferably about 0 ° C., and heat during high-pressure steam sterilization or gas sterilization can be used.

[0012]

The present invention will be described in more detail with reference to the following examples. (Method) as follows the Cl-PP (A ₁ and A _2), PVC-based molded product (B ₁ and B ₂₎ and PP-based molded article (C ₁ and C ₂₎
Was prepared. A ₁ : 20% chlorine content, 10% toluene solution viscosity 10
A 50-μm-thick film obtained by press-forming a 0-centipoise Cl-PP pellet at 120 ° C. A ₂ : 35% chlorine content, 10% toluene solution viscosity 15
A 70 μm thick film obtained by press-forming a 0-centipoise Cl-PP pellet at 100 ° C. B ₁ : Molding of the shape of an outlet provided in a usual infusion bag or the like shown in FIG. 1 obtained by injection molding a compound obtained by adding 10% by weight of di-2-ethylhexyl phthalate to PVC having a number average polymerization degree of 1500. Goods. B ₂ : A sheet obtained by inflation molding a compound obtained by adding 40% by weight of di-n-decyl phthalate to PVC having a number average degree of polymerization of 2500 (thickness: 300 μm, folding diameter: 150)
mm) in the form of a normal infusion bag or the like shown in FIG. C ₁ : A molded product obtained by injection molding pellets of an isotactic type PP copolymer of MFR 8.2. Shape is B
Outlet shape similar to ₁ . C ₂ : A sheet (thickness: 300 μm, folded diameter: 150 mm) obtained by inflation molding pellets of an isotactic type PP copolymer having MFR of 2.1 into a shape such as a normal infusion bag shown in FIG. Goods.

Preparation of Container The above-mentioned A ₁ and A ₂ are cut and wrapped around the roots of the discharge ports B ₁ and C ₁ , and only that part is inserted into the mounting part 4 in FIG. 100 ° C, pressure 2kg / c
The outlet was attached under the conditions of m ² and time of 10 seconds. Less than,
The combination at that time is shown. Example 1: Discharge port B ₁ , adhesive film A ₁ , bag B ₂ Example 2: Discharge port B ₁ , adhesive film A ₂ , bag C ₂ Example 3: Discharge port C ₁ , adhesive film A ₁ , bag B ₂ Example 4: Outlet C ₁ , adhesive film A ₂ , bag C ₂

High-pressure steam sterilization 500 ml of physiological saline is put into each of the above-mentioned containers (examples), and a cap provided with a rubber stopper for infusion above the outlet (the cap is made of the same material as the outlet. ,
Cap when the outlet B ₁ represents PVC, cap when C ₁ is PP. ), And the cap and the outlet were fused by an ultrasonic sealing method. Next, the container with the drug solution was put into a high-pressure steam sterilizer, and the temperature was 110 ° C. and the gauge pressure was 1.8 kg / c.
The solution was sterilized under the conditions of m ² and 30 minutes, and cooled to room temperature.

Evaluation In each example, the above sterilization treatment was performed on 10 containers, and the outlet / adhesive film (A
₁ or A ₂ ) / The close contact state between the bags and the leakage state of the internal chemical solution were observed.

(Results) Before and after sterilization, there was almost no change in the appearance between the discharge port and the adhesive film, and between the adhesive film and the bag. Also, there was no leakage of the content liquid. In addition, according to the Japanese Pharmacopoeia (13th revision) general test method “Plastic drug container test method”, the raw material pellets of each example were subjected to heavy metal and dissolution test, and it was confirmed that both were compatible. .

(Comparative Example) The same experiment as in Examples 1 and 2 was performed using an acid anhydride-modified polyolefin film having a thickness of 70 μm instead of the adhesive films A ₁ and A _2. There was no adhesion between the product (B ₁ or B ₂ ) and the acid anhydride-modified polyolefin film, and the stage of the high-pressure steam sterilization experiment (the above-mentioned method-) was not reached.

[0018]

As described above, the medical container of the present invention
In the member for instruments, the polyvinyl chloride-based molded article and the polypropylene-based molded article are adhered via the chlorinated polypropylene, and the adhesive strength of the adhered portion is not weakened even during high-pressure steam sterilization. Therefore, it can withstand high pressure steam sterilization,
Since the confidentiality and liquid tightness of the medical container / instrument members can be maintained, they are also excellent in safety and hygiene.

[Brief description of the drawings]

FIG. 1 is a longitudinal sectional view of a molded product having a discharge port shape provided in a normal infusion bag or the like manufactured in an example.

FIG. 2 is an external view of a molded product formed into a shape such as a normal infusion bag or the like manufactured in an example.

[Explanation of Signs] 1 ... Molded product, 2 ... Seal part, 3 ... Seal part, 4 ... Mounting part

──────────────────────────────────────────────────の Continuation of the front page (51) Int.Cl. ⁶ Identification code Agency reference number FI Technical display location B32B 27/30 101 C08J 5/12 CES C08J 5/12 CES CEV CEV A61J 1/00 331A

Claims (2)

[Claims] 1. A member for a medical container or device in which a polyvinyl chloride-based molded article and a polypropylene-based molded article are adhered via chlorinated polypropylene. 2. The chlorinated polypropylene has an amount of chlorine of 1
The member for medical containers and instruments according to claim 1, wherein the content is 5 to 50% by weight.