JP3455612B2 - Medical equipment - Google Patents

Description

Detailed Description of the Invention

[0001]

FIELD OF THE INVENTION This invention relates to medical devices. More specifically, the present invention relates to a medical container suitable for containing a liquid such as blood and medical liquid used in the medical field.

[0002]

2. Description of the Related Art Containers (bags) used in the medical field such as blood collection, blood transfusion, and liquid transfusion are required to have various performances in addition to safety and hygiene. Above all, flexibility, transparency and heat resistance are important items. Soft polyvinyl chloride has been widely used since it meets almost all of these requirements, but it may cause problems in the elution, coloring, and disposal of plasticizers, such as ethylene-based polymers and propylene-based polymers. The transition to polymers (hereinafter, sometimes referred to as polyolefin-based or simply polyolefin, which is synonymous) is progressing, and it has become the mainstream of container materials for infusion.

On the other hand, a so-called "exhaust port" (in the present invention, also means an injection port for injecting blood or infusion) is almost always provided in a medical container. Generally, an olefin polymer is used like a bag, but in terms of high rigidity required when piercing an injection needle, transparency to observe the inside, etc. It is one of the important materials because it has sufficient hygiene. However, polycarbonate is difficult to adhere to a polyolefin-based material, and its application to the discharge port is limited in reality.

[0004]

SUMMARY OF THE INVENTION In view of the above, an object of the present invention is to provide means suitable for industrially manufacturing a medical device such as a polyolefin medical bag having a discharge port made of polycarbonate. Especially.

[0005]

Means for Solving the Problems The gist of the present invention is medical treatment in which a medical bag made of a polyolefin sheet and a polycarbonate mouth are adhered via a styrene thermoplastic elastomer or a polymer composition containing the same. Equipment. It is well known that styrene-based thermoplastic elastomers have excellent compatibility (affinity) with polyolefins, but they also have an affinity that allows them to adhere to polycarbonate, and in medical devices, they are usually used. It has not been known that the adhesive strength is maintained even in the high-pressure steam sterilization treatment performed.

First, the polyolefin sheet used in the present invention is preferably flexible in the sense that it can be drained without a ventilating needle (in a so-called closed system) at the time of use (for example, drip), and has a flexural modulus (JISK72).
03) is preferably 3,000 kg / cm ² or less, more preferably 2,500 kg / cm ² or less, and the thickness of the polyolefin or the polymer composition containing polyolefin as a main component is preferably 0.05 to 0.6 mm. Preferably 0.1-0.5
A flexible sheet of mm is suitable, and in consideration of internal visibility (transparency), it is recommended to select the following polymer or polymer composition as a base.

(A) Ethylene polymer: butene-1,
Linear low density of density 0.908 to 0.9252 / cm ³ obtained by copolymerizing about 2 to 20 mol% of α-olefins such as pentene-1, hexene-1, octene-1, 4-methylpentene-1 Polyethylene (LLDPE), ethylene-vinyl acetate copolymer (EVA) having a vinyl acetate content of 5 to 25% by weight, and the like. Considering the moldability and the mechanical properties of the molded product (sheet), the temperature is 190 ° C and the load is 2,16.
Melt flow rate (MFR) at 0g is 0.5-
It is preferably 10 to 1, more preferably 1 to 8.

(B) Propylene-based polymer (or polymer composition thereof): isotactic or syndiotactic type crystalline polypropylene or a crystalline copolymer (referred to as PP) containing these as the main components and atactic type 1. A polymer composition with the amorphous polypropylene or a copolymer (referred to as APP) containing the amorphous polypropylene as a main component. The ratio of PP to APP is 30: 7 by weight.
0 to 70:30 is preferable. Further, PP has a MFR at a temperature of 230 ° C. and a load of 2,160 g of from 0.3 to 20, preferably 0.5 to 15, and APP has a melt viscosity at 190 ° C. of from 300 to 100,000 cps. It is preferably 500 to 80,000 cps. In addition, PP
Since a polymer composition of a polymer and APP may have tackiness (blocking property) when a sheet surface layer is formed, practically, the layer of the polymer composition is sandwiched with an LLDPE layer or a PP layer. It is better to sandwich it.

(C) Polymer composition containing ethylene-based polymer or propylene-based polymer as a main component: (a),
A polymer composition obtained by blending 5-30% by weight of an ethylene-based elastomer (described later), a styrene-based thermoplastic elastomer (described later) and the like with (2) LLDPE or PP. In the present invention, it goes without saying that the sheet includes not only a single-layer structure but also a multi-layer structure as described in (b) above, and in some cases, polyester, polyamide, ethylene vinyl alcohol copolymer and the like are included in the gist of the present invention. Can be multilayered as long as it does not impair (to the extent that the olefin-based polymer or the polymer composition containing the same forms the inner wall layer of the container, that is, the adhesive surface to the molded article made of polycarbonate). The multi-layer structure is generally performed for the purpose of improving the strength, heat resistance, gas barrier property, etc. of the sheet.

Next, the polycarbonate in the present invention is a generally known one having a basic structure of poly-4,4'-dioxydiphenyl-2,2-propane carbonate. Because of the mechanical properties,
Viscosity average molecular weight 2 measured using methylene chloride as a solvent
Those having a range of 0000 to 100,000 are preferably used. The viscosity average molecular weight is calculated according to the H.V. Schne
It is determined by the viscosity equation of 11 [Η] = 1.23 ×
10 ^-5 M ^0.83 (η: intrinsic viscosity, M: viscosity average molecular weight)

Next, typical examples of the styrene type thermoplastic elastomer in the present invention will be given below. These can be manufactured by a generally known method. (1) SEBS: block (polystyrene-ethylene butylene copolymer-polystyrene) polystyrene-polybutadiene (1,2-bond and 1,
4-Block Copolymer with Conjugate) -A block copolymer obtained by hydrogenation of a polystyrene type triblock copolymer (SBS). Considering compression set, moldability, and other mechanical properties, the total of polystyrene parts (S parts) at both ends is 10 to 60 in SEBS.
%, More preferably 15 to 50% by weight. Also, ethylene butylene copolymer part (EB part)
It is preferable that the butylene portion in the EB portion accounts for 20 to 90% by weight, more preferably 30 to 80% by weight. SEBS has a MFR (melt flow rate) at a temperature of 230 ° C. and a load of 2,160 g of preferably 0.5 to 0.5.
20 and more preferably 1 to 15 are recommended.

(2) SEPS: Block (Polystyrene-Ethylene-Propylene Copolymer-Polystyrene) Similar to the case of SEBS, a polystyrene-polyisoprene-polystyrene type triblock copolymer (SI
Obtained by hydrogenation of S). Considering the same matters as SEBS, the total of polystyrene parts (S parts) at both ends is preferably 10 to 60% by weight, more preferably 15 to 50% by weight in SEPS, and the MFR is 0.5 to 0.5.
20 and more preferably 1 to 15.

(3) SEBE: block (polystyrene-ethylene butylene copolymer-polyethylene) polystyrene-polybutadiene (1,2-bond and 1,
4-bonded copolymers) -hydrogenated of triblock copolymers of the poly-1,4-butadiene type. S
Considering the same matters as EBS, the polystyrene part (S
Part), the ethylene butylene copolymer part (EB part) and the polyethylene part (E part) are preferably in a weight ratio of 10 to 10.
50:30 to 70: 5 to 30 and more preferably 15 to 4
5:35 to 65: 8 to 25, and the amount of butylene in the EB part is preferably 30 to 90% by weight. Further, the MFR is preferably about the same as SEBS.

(4) SEPE: block (polystyrene-ethylene propylene copolymer-polyethylene) polystyrene-poly-1,4-isoprene-poly-1,
It can be produced by hydrogenation of a triblock copolymer of 4-butadiene structure. Considering the same matters as SEBS, polystyrene part (S part), ethylene propylene copolymer part (EP part) and polyethylene part (E part)
The weight ratio of is preferably 10 to 50:30 to 70: 5.
30 More preferably 15-45: 35-65: 8-2
5 and an MFR of about the same as SEBS are preferable.
In addition to the above (1) to (4), block (polystyrene-poly-1,2-isobrene polystyrene) or its hydrogenated product is also one of the styrene-based thermoplastic elastomers preferably used.

These styrene-based thermoplastic elastomers can be used alone, but they are used as a polymer composition with "other polymers" for the purpose of enhancing the adhesiveness with the polyolefin-based sheet and improving the moldability. Also used in the form of. In this case, the amount of the styrene-based thermoplastic elastomer in the polymer composition is preferably 50% by weight or more from the viewpoint of adhesion to polycarbonate. Representative examples of "other polymers" are shown below.

(A) Ethylene elastomer: An amorphous or low crystalline soft polymer (elastomer) among copolymers of ethylene and α-olefins such as propylene, butene-1, and hexene-1. Ethylene content 25-75% by weight, temperature 230 ℃, load 2,160g
Has an MFR of 0.5 to 15, more preferably 1 to 10
It should be about the degree. (B) A polymer of the same type as the container sheet: that is, a polymer of the same type as the polyolefin forming the inner wall layer of the container sheet. For example, if the container sheet is LLDPE, "other polymer" is also LLDPE.

When the medical container of the present invention is a container, blood components such as red blood cells, platelets and plasma, physiological saline, electrolyte solution, dextran preparation, mannitol preparation, saccharide preparation, amino acid preparation, fat emulsion, etc. Infusion is stored and stored. In addition, the mouth part is a discharge port for discharging the content liquid, an injection port that plays a role of injecting a liquid medicine, blood, etc.,
It refers to a member such as a so-called broken communication pipe that allows objects to be taken in and out between the inside and outside of the medical container. The mouth portion itself generally has a circular cross section, but the joint portion (sealing portion) with the container bag may be devised such as having a “boat shape”.

As described at the beginning, in the present invention, the molded product (member (a)) made of the polyolefin resin and the molded product (member (b)) made of polycarbonate are styrene thermoplastic elastomer or a polymer composition containing the same. It is adhered via the object (adhesive member (c)),
(1) A method of separately molding (a), (b), and (c) as members and adhering them, (2) a member in which (b) and (c) are integrated by two-color molding or insert molding After that, it is manufactured by a process such as a method of bonding with (A). In addition, as a special form, (3) (c) is (a)
There is also a case where (c) is a part or all of (a).

Below, the member (a) is referred to as a medical bag and the member (b).
The following is an example of manufacturing when is the mouth of a medical bag. The medical bag (a) is usually obtained by a known method. For example, a polyolefin can be fed through a T-die or circular die for 150
If the flat sheet, tubular sheet, parison or the like obtained by extruding at ~ 250 ° C. is processed into a predetermined shape and form by appropriately utilizing techniques such as thermoforming, blowing, stretching, cutting, and fusion bonding. Good. Mouth (b)
Is a resin temperature of 260 to 320, which is usually determined by a known injection molding method.
It is usually manufactured under the conditions of a temperature of 60 ° C. and a mold temperature of 60 to 110 ° C. The adhesive member (c) may be injection-molded or extrusion-molded, and is molded under the condition of a temperature of 160 to 230 ° C., and is obtained in the shape of a cylinder (tube) or a sheet. As described above, integral molding with the mouth portion (b) is possible, and in some cases, coextrusion molding with the container sheet may be possible. When the heat sealing method is used, the adhesion between (a) and (c) is 130
~ 200 ℃, (b) and (c) 140 ~ 25
It is performed at a temperature of about 0 ° C. If appropriate conditions are selected within this range, the 180 ° peel strength indication will show an adhesive force of 2 kg / cm or more between (a) and (c), and 1 kg / cm or more between (b) and (c). Is obtained, which is practically sufficient.

[0020]

The present invention will be described in more detail with reference to the following examples. (Experimental method) (1) Preparation of raw material polymer and polymer composition: Tables 1 and 2 show pellets of the polymer and polymer composition used in this experiment, respectively. Here, the polymer composition was prepared at 180 to 200 ° C. using a biaxial melt kneading extruder. (2) Preparation of bag for container: A resin selected from the polymers in Table 1 and the polymer composition in Table 2 is supplied to a single-layer or multi-layer circular die (inflation die), and then 180-
After extruding a tubular sheet at 200 ° C and cooling with a water cooling ring, a sheet with a thickness of 0.35 mm and a folding diameter of 150 mm is 5 m.
It was wound at a speed of / minute. Table 3 shows the sheet layer structure. Then, the sheet is cut into a length of 220 mm, and both open ends are heat-sealed (the sealing temperature is 160 to 170 ° C.) and cut so that a non-sheet portion communicating between the inside and the outside of the sheet is left at one end, and the sheet is cut as shown in FIG. A bag 1 having such a shape was produced.

(3) Preparation of Adhesive Tube: A resin selected from the polymers of Table 1 and the polymer composition of Table 2 was extruded from a tube die at 190 to 200 ° C. to give an outer diameter of 15 mm.
/ A tube with an inner diameter of 12 mm was obtained (take-off speed 8 m / mi
n). (4) Preparation of outlet main body: Polycarbonate (Polymer D in Table 1) was injection molded at 270 ° C. to obtain a tubular body 5 (having a circular cross section) shown in FIG. Next, the bonding tube obtained in (3) was cut into a length of 15 mm and inserted into the base of the discharge port of the tubular body 5 to prepare the discharge port body 4. Outlet body 4
Has a total length of 45 mm and is composed of a tubular body 5 and an adhesive tube 6. The tubular body 5 has a cylindrical shape with an inner diameter of 8 mm and an outer diameter of 15 mm, and has a flange 7 with an outer diameter of 20 mm at one end. Also,
15 mm from the other end is a small diameter portion 8 having an outer diameter of 12 mm, and the bonding tube 6 is attached here. (5) Attaching the outlet main body to the bag: The outlet main body 4 with the adhesive tube attached is inserted into the attachment portion 3 of the bag 1 shown in FIG. 1 only at the portion where the adhesive tube 6 is attached, Sandwiched between molds, temperature 150-180 ℃, pressure 2kg /
The discharge port body 4 was attached under the conditions of cm ² and time of 10 seconds (the temperature condition was selected to be the range with the best adhesion state in each Example / Comparative Example).

[0022]

[Table 1]

[0023]

[Table 2]

[0024]

[Table 3]

(6) Preparation of container: 500 ml of physiological saline was put in the bag 1 having the outlet body 4 obtained in (5) attached thereto,
Cover the top of the outlet body 4 with a cap (not shown) of a polycarbonate bag in which a rubber plug for infusion is attached in the center, and fuse the cap and the outlet body by ultrasonic sealing to form the outlet and the bag. A medical container consisting of Then, it was placed in a high-pressure steam sterilizer, sterilized under conditions of a temperature of 110 ° C., a gauge pressure of 1.8 kg / cm ² and a time of 30 minutes, and cooled to room temperature. (7) Evaluation: In each Example / Comparative Example, the sterilization treatment of (6) was performed on three containers, and the close contact state between the discharge port / adhesion tube / bag and the leak state of the internal chemical solution were observed after sterilization. . Table 4 shows combinations of the bag 1 and the adhesive tube 6.

[0026]

[Table 4]

(Experimental Results) (1) As shown in Table 4, the polyolefin-based container sheet and the polycarbonate outlet can be satisfactorily processed by interposing a styrene-based thermoplastic elastomer (or a polymer composition thereof). It was confirmed that they would be bonded.
On the other hand, it was shown that when the styrene-based thermoplastic elastomer was not used, it could not adhere to the polycarbonate. (2) Further, the heavy metal and eluate tests of the raw material pellets in Table 1 were sequentially performed according to the Japanese Pharmacopoeia General Test Method “Plastic Container Test Method for Infusion”, and it was confirmed that all polymers were compatible.

[0028]

As described above, the medical device of the present invention provides means for attaching a polycarbonate molded article to a polyolefin molded article by making good use of a styrene-based thermoplastic elastomer, and is used in the medical field. Expected to make a significant contribution.

[Brief description of drawings]

FIG. 1 is a view showing a container bag used in Examples or Comparative Examples.

FIG. 2 is a view showing a cross section of an outlet main body used in an example or a comparative example.

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Claims (2)

(57) [Claims] 1. A molded article comprising an olefin polymer,
A medical device comprising a molded article made of polycarbonate and a styrene-based thermoplastic elastomer or a polymer composition containing the same bonded to each other. 2. An olefin-based polymer is an ethylene-based polymer, a propylene-based polymer or a polymer composition containing them as a main component, and the constituent unit of the styrene-based thermoplastic elastomer is polystyrene-ethylene butylene copolymer-polystyrene, polystyrene-ethylene. The medical device according to claim 1, which is any one of propylene copolymer-polystyrene, polystyrene-ethylene butylene copolymer-polyethylene, and polystyrene-ethylene propylene copolymer-polyethylene.