JP2000157610A - Medical vessel - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a medical use vessel endurable to high pressure steam sterilization of a temperature not less than 120 deg.C. SOLUTION: In this heat resistant medical use vessel, an outer layer of a vessel wall is composed of a mixed resin containing low density polyethylene in a range of 20 to 50 wt.% in linear polyethylene obtained by using a metallocene catalyst having density in a range of 0.935 to 0.950 g/cm3. An inner layer of the vessel wall is composed of a mixed resin containing polypropylene in a range of 25 to 50 wt.% in linear polyethylene having density in a range of 0.910 to 0.930 g/cm3. In this case, a thickness of the vessel wall is set to 100 μm to 300 μm.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical container containing a chemical solution. The present invention relates to a resin container basically having flexibility and transparency, and particularly to a medical container capable of withstanding high-pressure steam sterilization at a temperature of 120 ° C. or higher.

[0002]

2. Description of the Related Art Medical containers are replacing glass containers with resin containers. Since the resin container is a flexible container, it does not require an air needle or the like at the time of use, and thus is preferable for a medical container. Its disposal is also easier than glass containers. The resin used for the container is polyvinyl chloride, ethylene-vinyl acetate copolymer, polyethylene or the like. Particularly, polyethylene resin containers are frequently used because of the problem of container disposal and the fact that the contents are not adversely affected.

[0003]

In general, it is desirable that the wall of a medical resin container is excellent in heat resistance, transparency and flexibility (dropping property of a liquid content). As such a resin container, there is a polyethylene container. It is known that conventional polyethylene containers have excellent heat resistance, transparency, and flexibility. However, when high-pressure steam sterilization is performed on such a container, the heating temperature is 115 ° C. or less. High pressure steam sterilization of such containers at higher temperatures may deform the containers. In addition, there may be a case where the inner walls or the outer walls of the container adhere to each other, so that the walls cannot be completely separated from each other. For this reason, a polyethylene container for medical use having more heat resistance is desired. Recently, a heat-resistant container using high-density polyethylene has been proposed (JP-A-4-266759).
No.). In this polyethylene container, the container wall has a laminated structure of different kinds of resins. The outer layer of the container wall is made of a resin in which low-density polyethylene is mixed with high-density polyethylene of about 5 to 40%. The heat resistance of the container wall is maintained by high-density polyethylene. There is also a medical container using a heat-resistant polypropylene-based resin, but such a container has a problem that a large amount of elutes such as fine particles from the inner layer are present. An object of the present invention is to provide a medical container that can withstand high-pressure steam sterilization at a temperature of 120 ° C. or higher.

[0004]

The present invention relates to a medical container which is a container having a transparent and flexible container wall having a multilayer resin structure and which is subjected to high-pressure steam sterilization together with a contained chemical solution. The outer layer of the vessel wall has a density of 0.9
A low-density polyethylene was added to the linear polyethylene obtained using a metallocene catalyst in the range of 35 to 0.950 g / cm ^3.
The inner layer of the container wall is made of a linear polyethylene having a density of 0.910 to 0.930 g / cm ³ and a polypropylene of 25 to 50% by weight.
The present invention provides a medical container comprising a mixed resin in a range of 50% by weight, wherein the thickness of the container wall is 300 μm or less and 100 μm or more.

[0005] In the medical container of the present invention, the container wall has a multilayer resin structure. The medical container of the present invention basically has transparency and flexibility. The transparency of the container is such that impurities such as precipitates and fine particles in the chemical solution contained in the container can be confirmed. The container is flexible enough to allow the contained drug solution to drop naturally from an outlet or the like to which a drip needle or the like is attached. The medical container is blow molded, compressed air molded, vacuum molded, injection molded, or formed by cutting a film or sheet appropriately and sealing the periphery by heat sealing. When the container wall has a multilayer structure of resin, it is formed by co-extrusion of each resin in blow molding, pressure molding, vacuum molding, injection molding or the like. When a film or sheet is used, the film or sheet is formed by co-extrusion, or each resin film is individually formed and then laminated.

[0006] The medical container of the present invention contains a drug solution such as an infusion solution, a dialysate, and an organ preservation solution. After the chemical solution is stored in the container, it is subjected to steam sterilization together with the container. The steam sterilization process is different from the conventional one, and is desirably performed at a temperature of 120 ° C or higher.
At such a processing temperature, sterilization of the chemical solution can be performed completely and quickly.

The outer layer of the container wall has a density of 0.935 to 0.935.
In the range of 0.950 g / cm ^3, the linear polyethylene obtained using a metallocene catalyst was mixed with
It consists of a mixed resin contained in the range of 0% by weight. The outer layer has heat resistance, transparency and flexibility. For this reason, the outer layer can be thickened in order to increase the mechanical strength of the container wall. The thickness of the outer layer is desirably 100 μm or more. However, the thickness of the outer layer is desirably 300 μm or less, and if the thickness exceeds this thickness, the transparency of the container wall is lost. Therefore, the thickness of the container wall is 10
The upper limit is from 0 μm to 300 μm.

The linear polyethylene has a density of 0.935.
０．９0.950 g / cm ³ , especially 0.940-0.9
It is desirable to be in the range of 45 g / cm ³ . When a material having a density lower than the above range is used for the outer layer, sufficient heat resistance cannot be imparted to the outer layer. If the density exceeds the above range, the transparency of the outer layer may be lost.
The low-density polyethylene contains 2 in the linear polyethylene.
It is desirable to mix in the range of 0 to 50% by weight, particularly 25 to 40% by weight. By adding the low-density polyethylene in the above range, the transparency and flexibility of the outer layer can be sufficiently maintained. When the amount of the low-density polyethylene exceeds the above range, the heat resistance of the outer layer may be reduced.

The inner layer of the container wall has a density of 0.910 to 0.910.
It consists of a mixed resin containing linear low density polyethylene in the range of 0.930 g / cm ³ and polypropylene in the range of 25 to 50% by weight. Although the linear low-density polyethylene having the above density range has transparency, the heat resistance is not sufficient for this purpose. However, when polypropylene is mixed with the linear low-density polyethylene in the above range, the heat resistance as the inner wall of the container is sufficiently maintained. If the mixing amount of the polypropylene is less than the above range, when the container is subjected to high-pressure steam sterilization at a temperature of 120 ° C. or more, the inner wall surface of the container becomes rough and loses heat resistance. When the mixing amount of the polypropylene exceeds the above range, the inner layer may adversely affect the transparency of the container wall.

The above-mentioned metallocene-catalyzed linear polyethylene
Is a linear polyethylene obtained by ionic polymerization.
You. The ionic polymerization is carried out using a Zi-based catalyst (Kamminsky method).
Used. With metallocene catalyst by Kaminsky method
The linear polyethylene obtained from this method has molecular weight and stereoregularity
Distribution is narrow. For this reason, the container material to be heat treated is
Is particularly desirable because heat deformation and blocking are unlikely to occur.
No. The polymerization process is from atmospheric pressure to 100 (kg / cm²)
Where solution, slurry, or gas phase methods are used.
You. The linear polyethylene has a density of 0.935 to 0.9.
50g / cm ³Range, especially 0.940 to 0.945 g / cm³Range of
It is desirable to be in the surroundings. The linear polyethylene is
A small amount of α-olefin is copolymerized to adjust the density.
It is. When a few percent of α-olefin is copolymerized,
Short-chain branches are introduced into the main chain of ethylene,
Len is reduced in density. α-olefin is propylene,
Butene-1, hexene-1, 4-methylpentene-1,
Octene-1 and the like.

The low-density polyethylene is 1000-3
It is produced by radical polymerization under high pressure of 000 kg / cm ² . During the radical polymerization, a branched chain comparable to the main chain is generated by a hydrogen abstraction reaction in the molecule, and the polyethylene has a low density. The density of the above polyethylene is 0.91
0 to 0.935 g / cm ³ , especially 0.922 to 0.9
It is desirable to be in the range of 33 g / cm ³ . Also, since medical bags are required to have as high a heat resistance as possible, the low-density polyethylene has a biquad softening point (JI
S: K6760 method) is preferably in the range of 95 to 110 ° C.

The above-mentioned linear low-density polyethylene is a linear polyethylene obtained by ionic polymerization. The ionic polymerization uses a Ti-based catalyst (Ziegler method), a Cr-based catalyst (Philip method), or a Zi-based catalyst (Kamminsky method). Among them, linear polyethylene obtained by a metallocene catalyst by the Kaminsky method has a narrow molecular weight and a narrow stereoregularity. For this reason, a container material to be subjected to a heat treatment is particularly desirable in that heat deformation and blocking hardly occur.
The polymerization process is carried out under conditions ranging from atmospheric pressure to 100 (kg / cm ² ).
A solution method, a slurry method, or a gas phase method is used. The linear low-density polyethylene has a density of 0.880 to 0.9.
35 g / cm ³ range, especially 0.910 to 0.930 g / cm ³
Is desirably within the range. In order to adjust the density of the linear low-density polyethylene, a small amount of α-olefin is copolymerized. When the α-olefin is copolymerized by several percent, short-chain branches are introduced into the main chain of the linear low-density polyethylene, and the density of the linear low-density polyethylene is reduced. α-
Olefins are propylene, butene-1, hexene-1,
4-methylpentene-1 and octene-1. Vicad softening point temperature of the above linear low density polyethylene (JIS: K676
Method 0) is preferably in the range of 105 to 120 ° C. The linear low-density polyethylene has sufficient heat resistance, transparency and flexibility.

The above polypropylene resin is a polypropylene which is polymerized using a Ziegler-Natta catalyst. The polypropylene-based resin is a polypropylene that is polymerized using a metallocene catalyst. The polypropylene resin may be a copolymer obtained by copolymerizing a small amount of α-olefin. The polypropylene polymerized using the Ziegler-Natta catalyst is mainly isotactic polypropylene. The polypropylene polymerized using the metallocene catalyst is mainly an isotactic polypropylene and a syndiotactic polypropylene. The isotactic may contain a small amount of a by-product atactic polymer or the like. However, it is desirable that the above-mentioned isotactic polypropylene is obtained by removing the atactic polymer. Polypropylene polymerized using the above metallocene catalyst is desirable because the catalyst is soluble and has only one active site, so that the molecular weight and stereoregularity distribution are narrow. The syndiotactic polypropylene is polymerized using a metallocene catalyst comprising a cyclopentadienyl ring and a fluorenyl ring. Since the above-mentioned syndiotactic polypropylene is softer and more transparent than isotactic polypropylene, it is desirable to apply it to a flexible medical bag. The above propylene /
α-olefin copolymer, propylene / ethylene random copolymer, propylene / butene random copolymer,
And a propylene / ethylene / butene copolymer.
The α-olefin in the copolymer is 1 to 10% by weight, especially 3 to 10% by weight.
Desirably, it is contained in the range of about 7% by weight. α-olefins are ethylene, butene-1, hexene-1, 4-methylpentene-1, and octene-1. By copolymerizing the α-olefin with propylene, flexibility and transparency can be imparted to the polymer.
In general, a nucleating agent or the like is added to polypropylene to impart transparency. However, such a nucleating agent may not be used in a medical bag, so that the above copolymer is preferably used. The above polypropylene has a biquad softening point temperature (JIS: K
6758 method) is preferably a temperature of 140 ° C. or higher, and a polypropylene having the above temperature characteristics can exhibit heat resistance.

In the medical container of the present invention thus configured, the outer layer is transparent, so that its thickness is 300 μm.
m. For this reason, sufficient mechanical strength can be imparted to the container wall. The outer layer is not likely to be deformed during high-pressure sterilization at a temperature of 120 ° C. or higher. Since the outer layer is mainly composed of linear polyethylene, sufficient heat resistance is observed. For this reason, thermal deformation such as flapping or unevenness on the outer and inner surfaces of the container wall hardly occurs. The transparency and appearance of the container wall do not decrease during the high-pressure steam sterilization. When the thickness of the inner layer of the container wall is in the range of 10 to 50 μm, the flexibility and transparency of the container wall are not lost.
Therefore, the state of the medical solution in the medical container can be sufficiently observed, and the container wall sufficiently maintains the natural drip property at the time of infusion.

In the mixed layer containing a large amount of the above-mentioned polypropylene-based resin, a large amount of elutes such as fine particles come out after high-pressure steam sterilization. As compared with a single container wall of a single container or a container wall of a mixed resin rich in a polypropylene resin, the amount of eluted substances such as fine particles is small. Furthermore, since a blend in which the linear polyethylene and the polypropylene resin are mixed at a constant mixing ratio is provided as the heat sealing layer with a constant thickness in the inner layer, a fixed seal and a peelable seal between the container walls can be formed. Easy to do. Therefore, it is possible to easily provide a medical container in which the two components in the container are separated and stored until the time of use, and the peelable seal portion is peeled from the outside at the time of use.

[0016]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, embodiments of the medical container of the present invention will be described in detail. FIG. 1 is a plan view of an embodiment relating to the medical container of the present invention. FIG. 2 is an exploded sectional view of an embodiment relating to the medical container of the present invention. FIG. 3 is an enlarged cross-sectional view of the sheet of the embodiment relating to the medical container of the present invention.

As shown in FIG. 1, a medical container 10 according to the present embodiment is formed with two chambers 12, 14, and each chamber 12, 14 contains a different chemical solution 16, 18. Each room 12, 14
Are respectively provided with ports 20 and 22 of a filling port and a discharging port. As shown in FIG. 2 and FIG.
It is formed from two sheets 24 and 26. Each sheet 24,
Reference numeral 26 denotes a laminated structure in which the respective films are laminated. When the sheets 24 and 26 become the walls of the container 10, the outer layer 32 is formed as a heat-resistant resin layer and a reinforcing resin layer, and the inner layer 36 is formed as a heat seal layer.

The respective sheets 24 and 26 have their peripheral edges 28 fixedly sealed. The peripheral portion 28 is heat-sealed at a temperature of 150 ° C. During this heat-sealing seal, the inner layer 36 completely dissolves and the outer layer 32 participates in its adhesive seal. A detachable seal 30 is formed at the center of each of the sheets 24 and 26, and the medical container 10 is divided into the chambers 12 and 14 by the seal 30. The isolation seal part 30 is heat-sealed at a temperature of 125 ° C. Then, the inner layers 36, 36 of the respective sheets 24, 26 are heat-sealed and sealed to each other to form a seal portion 30 that can be peeled from the outside during use. After filling the medical container 10 with the liquid medicines 16 and 18 from the outlets, the chambers 12 and 14 are sealed, and the medical container 10 is subjected to high-pressure steam sterilization at 121 ° C. for 30 minutes. In use of such a medical container 10, after separating the seal portion 30, each of the medical solutions 16 and 18 is removed.
Are aseptically mixed, and a drip or the like is performed. Also, during storage, the easily reacting chemicals 16, 18 can be placed in an isolated state.

The sheet 24 of each embodiment of the medical container,
Table 1 shows the resin films of the outer layer 32 and the inner layer 36 constituting the film 26 and their thicknesses. Examples 1 to 4
And each resin film of Table 1 in Comparative Examples 1 to 7 is made of the following materials. Each of the above resin films is MPE / LP (1) ~
(5), and PE / PP (1) to (5). The MPE / LP (1) is a linear polyethylene polymerized by a metallocene catalyst (MP
This is a mixed resin obtained by mixing low-density polyethylene (LP) with E) at a ratio of 30% by weight. The density of linear polyethylene is 0.
940 (g / cm ³ ), and the density of the low-density polyethylene is 0.922 (g / cm ³ ). The MPE / LP (2) is a linear polyethylene (MPE) polymerized by a metallocene catalyst.
And a low-density polyethylene (LP) at a ratio of 15% by weight. The density of linear polyethylene is 0.9
40 (g / cm ³ ) and the density of the low-density polyethylene is 0.922 (g / cm ³ ).

The MPE / LP (3) is a mixed resin obtained by mixing low-density polyethylene (LP) with 60% by weight of linear polyethylene (MPE) polymerized by a metallocene catalyst. The density of linear polyethylene is 0.940 (g / cm ³ ), and the density of low-density polyethylene is 0.922 (g / cm ³ ). The MPE / LP (4) is a linear polyethylene (MPE) polymerized by a metallocene catalyst, a low-density polyethylene (L
P) is a mixed resin obtained by mixing 30% by weight. However, the density of linear polyethylene was 0.930 (g / cm ³ ), and the density of low-density polyethylene was 0.922 (g / c ³ ).
m ³ ). The MPE / LP (5) is a mixed resin obtained by mixing low-density polyethylene (LP) at a ratio of 30% by weight with linear polyethylene (MPE) polymerized by a metallocene catalyst. However, the density of linear polyethylene is 0.955 (g / cm
³ ) and the density of the low-density polyethylene is 0.922
(G / cm ³ ).

The PE / PP (1) has a density of 0.926 (g / cm
³ ) A mixed resin obtained by mixing 30% by weight of isotactic polypropylene having an isotactic pentad fraction of 0.88 with the low-density linear polyethylene. The PE / PP (2) is a low-density linear polyethylene having a density of 0.926 (g / cm ³ ) and an isotactic polypropylene having an isotactic pentad fraction of 0.88 in 10% by weight. It is a mixed resin mixed in a ratio. PE above
/ PP (3) is a low-density linear polyethylene having a density of 0.926 (g / cm ³ ) and isotactic polypropylene having an isotactic pentad fraction of 0.88 in a proportion of 60% by weight. It is a mixed resin. The above PE / PP (4)
A low-density linear polyethylene having a density of 0.926 (g / cm ³ ) has a syndiotactic pentad fraction of 0.87.
Is a mixed resin obtained by mixing 30% by weight of the syndiotactic polypropylene. The PE / PP (5) is obtained by mixing a low-density linear polyethylene having a density of 0.926 (g / cm ³ ) with a propylene-ethylene random copolymer containing 4% by weight of ethylene at a ratio of 30% by weight. It is a mixed resin. Table 1 shows each configuration of the container wall.

[0022]

[Table 1]

A medical container 10 was prepared from each sheet, and its heat deformation resistance, transparency, natural dropping property and sealing property were measured. The following items were measured for heat resistance. Whether or not blocking occurs on the inner wall of the container. It is also whether or not cloudiness or spots occur on the container wall. Further, whether or not the container wall is deformed such as wrinkles is determined. Those in which all of these items were good were regarded as having good heat resistance. At least one
Those having a defect in one of the items were regarded as having no heat resistance. Transparency was measured by the following method. A portion of the wall having a uniform thickness is taken from the sterilized container, and a measurement sample is prepared from this portion. Each sample is 0.9 × 4c
Five pieces cut to the size of m are produced. Fill the cell for measuring the ultraviolet absorption spectrum with water and immerse each sample in the water in the cell. The control is a cell filled with water only. The transmittance of each cell at a wavelength of 450 nm is measured by a light transmission measurement method. If the transmittance of the container wall is less than 55%, it is not allowed. The spontaneous dropping property was measured by the following method. A drip needle is connected to the outlet of the medical container, and a venous needle is placed 1.5 m below the position of the drip needle. The amount of liquid dropped from the venous needle is measured every unit time. ：: Variation of the drop amount per minute in each section is 8
It is within 0%. ×: Variation of the drop amount per minute in each section is 8
It is less than 0%. The peeling property of the isolation seal part 30 is examined by checking whether or not the peelable seal part is sufficiently peeled when the outside is manually pressed so as to press the chamber 12 of the medical container 10 to 0.2 kg / cm ² . The fixed sealing property of the peripheral portion 28 is 2 kg / c in the container 10.
examining a pinhole or the like when pressurized to m ^2, having no pinholes and leakproof acceptable product. Table 2 shows the results of the above evaluation.

[0024]

[Table 2]

As shown in Table 2, the measurement results of Examples 1 to 4 were good. In particular, the medical container in Example 3 had good appearance and transparency. In Comparative Example 1, the transparency of the container wall was not sufficient, and the natural dropping property was poor. In Comparative Example 2, the transparency of the container wall was not sufficient. In Comparative Examples 3 and 4, the outer surface of the container wall became rough after sterilization, the outer layer became white and cloudy, and it was difficult to measure the light transmittance of the container wall. In Comparative Example 5, the transparency of the container wall was not sufficient. In Comparative Example 6, the inner layer of the container wall became rough after sterilization, and the container wall became white and cloudy.
In addition, peeling was impossible. In Comparative Example 7, the transparency was not sufficient.

[0026]

As described above, in the heat-resistant medical container according to the present invention, the outer layer of the container wall has a density of 0.93.
A low-density polyethylene was added to the linear polyethylene obtained using the metallocene catalyst in the range of ^{5 to} 0.950 g / cm ^3.
The inner layer of the container wall has a linear polyethylene having a density of 0.910 to 0.930 g / cm ³ and a polypropylene of 25 to 5% by weight.
Since the thickness of the container wall is 300 μm or less and 100 μm or more, a medical container that can withstand high-pressure steam sterilization at a temperature of 120 ° C. or more is provided.

[Brief description of the drawings]

FIG. 1 is a plan view of a medical container according to an embodiment of the present invention.

FIG. 2 is a sectional view of a sheet according to an embodiment of the medical container of the present invention.

FIG. 3 is an enlarged sectional view of a sheet of an embodiment relating to the medical container of the present invention.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 10 Medical container 12, 14 chamber 16, 18 Chemical solution 20, 22 Outlet 24, 26 Sheet 28 Peripheral part 30 Isolation seal part 32 Outer layer 34 Intermediate layer 36 Inner layer

Claims (2)

[Claims] 1. A medical container in which the container wall has a multilayer resin structure, is transparent and flexible, and is subjected to high-pressure steam sterilization together with a stored chemical solution, wherein the outer layer of the container wall has a density of 0.935 ~ 0.950g /
A linear polyethylene obtained using a metallocene catalyst in the range of ³ cm ³ is composed of a mixed resin containing low-density polyethylene in the range of 20 to 50% by weight, and the inner layer of the container wall has a density of 0.910 to 0. 930g /
A medical container comprising a mixed resin containing linear polyethylene in a range of cm ³ and polypropylene in a range of 25 to 50% by weight, wherein the thickness of the container wall is 300 μm or less and 100 μm or more. 2. The container according to claim 1, wherein the thickness of the inner layer is in a range of 10 to 50 μm.