JPH10328269A - Medical container - Google Patents

Abstract

PROBLEM TO BE SOLVED: To keep the aseptic condition of a connecting part, to improve safety and to facilitate mixed pouring and mixing operation by separating the interior of the main body into a medical liquid storing part and a connecting part by a separating seal part comprising a separable seal part, and liquid tightly connecting a connecting port of the connecting part and a medicine container opening to each other through an elastic ring and a bacteria removing filter. SOLUTION: A separable separating seal part 12 is provided in the main body 2 of a medical container 1, thereby separating a storing part 2A for a medical liquid from a connecting cylinder member 11. A connecting port 13 of the connecting cylinder member 11 is provided with an elastic ring 14 and a bacteria removing filter 15. A protective seal material 16 comprising an air permeable sheet is air-tightly stuck to the connecting port 13 to keep the interior of the connecting cylinder member 11 in the steam sterilized state. The opening of a medicine container installed on the connecting port 13 and the connecting port 13 are liquid tightly connected to each other through an elastic ring 14 and the bacteria removing filter 15. By this arrangement, during preservation, the container can be kept clean and the bacteria removing filter 15 is kept from being soaked with a medical liquid before use. Accordingly deterioration can be prevented.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical container, and more particularly to a medical container used for administering a drug solution after aseptically co-injecting another drug such as an antibiotic. The present invention relates to a medical container with a connecting portion to be used.
In particular, the present invention relates to a medical container in which the attachment of the connecting portion is simple, the aseptic maintenance and safety of the connecting portion are high, and the co-injection and mixing operation at the time of use are easy.

[0002]

2. Description of the Related Art Medical containers such as bags and containers for infusions, dialysis solutions, organ preservation solutions and the like used for infusion are generally resin containers. In addition, some infusions are infused with antibiotics or the like at the time of use, and are then injected by infusion after mixing. A syringe is used for such co-injection or mixing. For example, a lysate is placed via a syringe into a vial containing the antibiotic. The antibiotic and the lysis solution are mixed, and the mixture is drawn back out of the vial with a syringe. Then, the syringe is pierced through the outlet of the infusion container, and the mixed solution is filled in the infusion container. Recently, various types of medical containers provided with a connecting portion such as a vial have been proposed in order to eliminate such complicated operations. The medical container provided with a connecting portion is provided with only a communicating means such as a vial to a resin container containing a drug solution or a solution, and the resin container and a drug container such as a vial are already connected at the connecting portion, Some containers remain in a state where they are not communicated with each other until use. The former is commonly referred to as a so-called half-kit medical container, and the latter is referred to as a full-kit medical container.

[0003] A half-kit medical container is composed of, for example, a flexible container and a cylindrical housing capsule extending upward from the upper end of the container. A needle is accommodated, and in use, one end of the communication needle is pierced into the rubber stopper at the mouth of the medicine container, and the other end of the communication needle is pierced through a rubber stopper provided at the upper end of the flexible container. A dissolving solution container provided with a communication means for a medicine container for communicating the inside with the inside has been proposed (JP-A-7-328).
No. 097). The lower opening of the cylindrical capsule is hermetically connected to the upper end of the flexible container, the upper opening is sealed by a sealing member, and the communication needle is aseptically accommodated in the capsule. As a full kit medical container, for example, a dissolving solution container, a cylindrical guide capsule provided at the upper end of the solution container as a connecting portion, and a double-head piercing type communication needle provided vertically movably in the guide capsule An infusion container has been proposed which comprises a medicine container such as a vial, a holder for holding the medicine container therein, and a cap for accommodating the holder and rotatably sealing the opening of the guide capsule (Japanese Patent Application Laid-Open No. HEI 9-208572). 7-
275324). By rotating the cap, the infusion container moves toward the communication needle without rotating the holder, the rubber stopper at the mouth of the medicine container is pierced into one end of the communication needle, and the connecting portion of the solution container is connected. The rubber stopper is pierced into the other end of the communication needle, and as a result, the inside of the medicine container and the inside of the solution container are connected.

[0004]

However, the medical container provided with the conventional connecting portion still has the following problems. Most of the medicine in the medicine container connected to the medical container cannot be sterilized by heating such as an autoclave. For this purpose, the drug is aseptically filled in a container, sealed with a rubber stopper and provided to the market. Aseptically filled drugs are not always maintained completely sterile. Therefore, it is conventionally considered to return the drug to the inside of the container via a sterilization filter when dissolving the drug in the drug solution. However, in each of the above-mentioned kits, long-term storage cannot be performed in a state where the sterilization filter is exposed to the chemical solution in the resin container. For this reason, communication needles for communicating with the inside of the main body and the mouth of the medicine container are provided on the upstream side and the downstream side of the sterilization filter when the medical solution flows through the medicine container, and the sterilization filter is kept in a dry state until use. Need to put. If the communication needle provided on the upstream side is not sufficiently aseptic, the aseptic maintenance of the mixture is impaired. Therefore, it is necessary to aseptically provide communication means on both sides of the sterilization filter at the connection portion. Further, it is necessary to provide the communicating means so as to be movable within the capsule and to be kept in a sterile state. In particular, when moving the medicine container, a constituent requirement that the mouth portion of the medicine container must be pierced with a communication needle before the rubber stopper of the flexible container is imposed, so that the accommodation structure in the capsule may be further complicated. There is. Further, it is necessary to provide a rubber stopper at the connection part or the connection port of the flexible container, and it is necessary to pierce the rubber stopper of the flexible container with a communication needle at the time of use. Is not always smooth. Accordingly, an object of the present invention is to provide a medical container in which the connecting portion can be easily attached, aseptic maintenance and safety of the connecting portion are high, and co-injection and mixing operation at the time of use can be easily performed. .

[0005]

According to the present invention, there is provided a resin-made main body containing a chemical solution, the main body having a connecting portion for connecting a medicine container containing a medicine mixed with the chemical solution. In the medical container, an isolation seal portion is formed on the main body, the isolation seal portion isolates the storage section for the chemical solution from the connection portion, and the isolation seal portion is a peelable seal portion, and the connection portion is separated. A medical container characterized in that an elastic ring material and a sterilization filter are provided at a connection port of the portion, and the connection port and the mouth of the medicine container can be liquid-tightly connected via the elastic ring material and the sterilization filter. The above object has been achieved by providing the above.

The chemical solution contained in the main body of the resin container is generally an electrolyte solution. Examples thereof include Ringer's solution containing lactic acid, acetic acid, bicarbonate and the like, high calorie infusion containing sugar, amino acid, peptide, fat, etc., dialysate, organ preservation solution and the like. The chemical may be a simple solution or dilution of the lyophilized drug, and the chemical may be simple sterile water. The chemical is steam sterilized after being housed in a resin container in a liquid-tight manner. Steam sterilization temperature is 100 ℃ ～ 14
It is desirable to sterilize at 0 ° C., particularly at a temperature of 105 ° C. to 115 ° C. At a sterilization temperature below the above range, it takes time and sterilization may be insufficient. On the other hand, if the sterilization temperature exceeds the above range, the plastic container and the packaging material are undesirably subjected to thermal deformation, thermal deterioration and the like.

[0007] The resin container has a flexible wall. The flexible wall may be any as long as the volume in the container is easily changed by bending. Further, it is desirable that the resin container wall has transparency to the extent that the contents can be confirmed. This is necessary for confirming the state of the chemical solution in the container. The resin container is formed from an inflation film, a tube, a sheet, and a film, or is formed by extrusion, injection, or blow molding. The resin material of the medical container is a general-purpose resin such as polyolefin resin, vinyl chloride, vinylidene chloride resin, polyester resin, polyvinyl alcohol resin, polyacrylonitrile resin, polyacrylic acid resin, polyamide resin, and the like. . Further, the resin container may be formed in a single layer or a multilayer. The innermost layer in contact with the drug in the resin container is desirably a resin layer that does not affect the drug and does not generate elutes. As such a resin, a polyolefin-based resin is desirable, and examples thereof include low-, middle-, and high-density lower-grade olefin resins such as polyethylene and polypropylene.
It is desirable that a gas barrier layer is formed on the resin container wall. In particular, a layer that does not easily transmit oxygen or the like is desirable. Examples of such a gas barrier layer include a metal layer made of aluminum or the like which hardly transmits gas at all or an inorganic vapor-deposited layer made of silicon oxide, magnesium oxide, titanium oxide, etc., and polyvinylidene chloride, polyester, nylon, ethylene, and the like. -A resin layer having a high gas barrier property, such as a vinyl alcohol copolymer and a fluororesin. The oxygen permeation amount of the gas barrier layer in the resin container is 40 cc · 20 μ / m ² · day · atm
(Temperature: 20 ° C.) or less, especially 30 cc · 20 μ / m ²
・ Day ・ atm or less, preferably 5cc ・ 20μ
/ M ² · day · atm or less, and 1 cc · 20μ /
Desirably, it is equal to or less than m ² · day · atm. Further, it is desired that the wall of the resin container has such transparency that the medicine inside can be confirmed as described above. For this reason, it is desirable that at least a part of the wall made of a metal layer such as the aluminum layer having an excellent function of not allowing gas to permeate at all be formed so that the metal layer can be peeled off. In the resin container having such a layer, deterioration of the medicine can be sufficiently prevented at the time of heating in high-pressure steam sterilization.

[0008] The main body of the resin container has a connecting portion for communicating with the inside of the medicine container. The connecting portion includes a passage communicating the inside of the main body with the outside of the main body, and the connecting portion may be a cylindrical member attached to or integrally formed with the main body. An isolation seal portion is formed on the main body, and the accommodation portion for the chemical solution and the attachment portion of the connection portion are isolated by the isolation seal portion. Due to such isolation, there is no danger that the chemical solution permeates to the connecting portion during storage of the container and wets a sterilizing filter or the like described later. The isolation seal portion is a close-contact seal in which the body inner walls of the main body are liquid-tightly sealed, and the isolation seal portion may be a liquid-tight seal via an adhesive or a heat-sealing seal between resins. As an adhesive, a ketone solvent, an ester solvent,
There is a hermetic seal via a solvent adhesive such as an ether solvent, a hydrocarbon solvent, or a halogenated hydrocarbon solvent, or a resin adhesive such as a modified olefin or a hot melt. In addition, as the heat welding seal, heat sealing, adhesion by external heating such as impulse seal, or ultrasonic bonding,
Adhesion by internal heating such as high-frequency bonding can be given. In particular, a heat sealing seal is preferable for the isolation seal portion.
With a heat-sealed seal, sealing can be performed from the outer wall side of the main body, and there is no risk of contaminating the inside of the main body during sealing.

[0009] The isolation seal is a peelable seal. The peelable seal is usually called a peel seal or a weak seal, and is a seal that can be peeled off when the inside of the container or the container is squeezed from the outside and a constant pressure is raised, or the outer wall of the container. Is a seal or the like that can be peeled off when each of them is gripped and pulled. The peel strength of such a close-contact seal is such that the pressure inside a chamber such as a container is 0.01 to 1.0 kgf / cm ² ,
It is desirable to have a peeling strength at a pressure of 0.05 to 0.5 kgf / cm ² . If the strength is lower than the above range, the safety for maintaining an isolated state at the time of production, transportation, storage and the like is lacking.
If the strength exceeds the above range, there is a possibility that the communication operation between the rooms cannot be easily performed at the time of use.
When the peel seal is formed, it is desirable that both adhesive resin layers are blends of different resins. In particular, it is desirable that the different resins be made of resin blends having different hot-melting onset temperatures or Picad softening points and little compatibility. By having such a blended material layer, it is possible to easily set the sealing temperature conditions for peel seal bonding. Further, the relationship between the seal strength required for peel seal adhesion, that is, the easy peelability due to external force during use, and the seal strength that does not cause peeling during storage can be strictly set. That is, a resin having different compatibility is melt-mixed in the inner layer, and this is formed into a sheet to form a surface which is microscopically separated into portions having different thermal adhesiveness. Then, by determining the thermal fusibility of the microscopic portion between the bonding surfaces at an arbitrary temperature, the strength of the sealing strength is accurately provided, and the above-described effect is easily achieved.

[0010] An elastic ring material and a sterilization filter are provided at a connection port of the connection portion. The elastic ring material is a sealing material capable of sealing the connection port and the mouth in a liquid-tight manner when the mouth of the medicine container abuts. The elastic ring member is made of an elastic material such as rubber or thermoplastic elastomer. Rubbers include natural rubber, isoprene rubber, styrene rubber, butadiene rubber, nitrile rubber, ethylene propylene rubber, butyl rubber, silicone rubber, chloroprene rubber, acrylic rubber, chlorosulfonated polyethylene rubber, hydrin rubber, urethane rubber, polysulfide rubber, fluorine rubber, 1-2 butadiene rubber and the like can be mentioned. Examples of the thermoplastic elastomer include a styrene-based elastomer, a vinyl chloride-based elastomer, an olefin-based elastomer, a polyester-based elastomer, a polyamide-based elastomer, and a urethane-based elastomer. As the medical rubber, isoprene rubber, butadiene rubber, ethylene propylene rubber, butyl rubber, silicone rubber, and the like are desirable, and as the thermoplastic elastomer, an olefin elastomer, a polyester elastomer, and the like are desirable. It is desirable that the sterilizing filter has a pore diameter of 0.8 μm or less, preferably 0.45 μm or less, and particularly preferably 0.22 μm or less. A filter having a pore size exceeding the above range may not be able to sufficiently remove bacteria, and within the above range, a bacteria removing effect can be expected. In particular, when the pore size is 0.45 μm or less, most bacteria can be removed, and when the pore size is 0.22 μm or less, an effect of removing particles by destruction of bacteria can be expected. The sterilizing filter is preferably made of a material that can be subjected to ethylene oxide gas sterilization or high-pressure steam sterilization, and examples of such a material include cellulose mixed esters and polyvinylidene fluoride. Most of the sterilization filter according to the present invention is a hydrophilic filter that allows an aqueous solution to pass therethrough, but it is desirable that a filter having a hydrophobic portion from which air is partially leaked is used. For example, a peripheral hydrophobic filter or the like having an entirely hydrophilic filter and a peripheral edge having a hydrophobic function.

In the medical container constructed as described above, it is sufficient to attach an elastic ring material and a sterilizing filter to the connecting portion, and it is not necessary to movably provide a communication needle or the like as communication means. . At the time of storage, the sterilizing filter is not wetted with a chemical solution or the like, so that there is no possibility that the filter function is deteriorated during storage. When a medical container is used, the mouth of the medicine container is connected to the connection port in a liquid-tight manner, and thereafter, the isolation sealing material is peeled off only by pressing the container body, and the medicine is passed through the sterilization filter into the medicine container. Partly. After dissolving the drug in the drug solution, the solution is returned into the container body again to complete the co-injection operation. In this case, the medicine container can be airtightly connected to the connection port, or can be aseptically connected to the connection port in advance. Therefore, in the medical container, the connecting portion can be easily assembled and attached, the sterility of the connecting portion can be sufficiently maintained and the safety can be sufficiently achieved, and the co-injection and mixing operation at the time of use can be easily performed.

According to a second aspect of the present invention, there is provided the medical container according to the first aspect, wherein a protective sealing material is hermetically adhered to the connection port, and the protective sealing material is formed of a breathable sheet. Wherein the inside of the connecting portion is steam-sterilized together with the inside of the container body. The protective sealing material is a sheet that easily allows water vapor and gas to pass during high-pressure steam sterilization and ethylene oxide gas sterilization. still,
Sheets also include films. With such a breathable sheet, steam or gas permeates into the connecting portion during high-pressure steam sterilization or gas sterilization, and the inside of the connecting portion and the sterilization filter are reliably sterilized. In addition, in the case of high-pressure steam sterilization, moisture generated in the connecting portion after the sterilization can be easily discharged through the protective seal material. The air permeability of the sealing material is 100 seconds / 100 ml or less, preferably 42 seconds / 100 ml or less, particularly 18 seconds / 100 ml.
It is desirable that the volume be 100 ml or less. With such a sealing material, the connection port can be kept clean from storage to use, and the sterilizing filter is not damaged.

The medical container according to a third aspect of the present invention is the medical container according to the first aspect, wherein the other drug container is already provided at the connection port, and the inside of the drug container is connected to the inside of the main body. It is characterized by communication. In the medical container according to the present invention, a full kit medical container in which another drug container is previously attached to the connection port can be provided. In such medical containers, not only the connection port is kept sterile during storage, but also the resin seal body and drug container can be easily separated by simply peeling off the isolation seal during use. Can be communicated with. In addition, since the communication is performed via the sterilization filter, when the medical solution once circulated in the medicine container returns to the inside of the main body, the sterilization filter surely performs the sterilization process. Therefore, there is no possibility of causing contamination when the medical container is used. Further, in such a medical container, the connecting portion is constituted only by the cylindrical connecting member, the sealing member and the sterilization filter, and the number of parts is extremely reduced.

[0014]

DESCRIPTION OF THE PREFERRED EMBODIMENTS Preferred embodiments of the medical container according to the present invention will be described below in detail with reference to the accompanying drawings. FIG. 1 is a front view of a first embodiment of the medical container according to the present invention. FIG. 2 is a front view when the medical container of the first embodiment is used. FIG.
FIG. 2 is a front view of a sterilization filter used for the medical container of the first embodiment.

As shown in FIG. 1, a medical container 1 according to the first embodiment is shown.
Is a resin main body 2 in which the chemical solution 3 is housed, and is composed of a main body having a connecting cylinder member 11 for connecting the medicine container 4 in which the medicine 5 mixed with the medicine solution 3 is housed. The medical container 1 has an isolation seal portion 12 formed on the main body 2, the isolation seal portion 12 isolates the accommodating portion 2 </ b> A of the drug solution 3 from the connecting cylinder member 11, and a seal portion capable of peeling the isolation seal portion 12. At the same time, an elastic ring material 14 and a sterilization filter 15 are provided in the connection port 13 of the connection cylinder member 11. It can be closely connected. A protective seal member 16 is hermetically adhered to the connection port 13, and the protective seal member 16 is formed of a breathable sheet. The inside of the connection tube member 11 is subjected to steam sterilization.

To further explain the medical container 1 of the first embodiment, the container main body 2 is formed by cutting a blown film having a thickness of 250 μm into a predetermined length and sealing the cut end by heat sealing. A connecting tubular member 11 is attached to the end seal 7 of the main body 2 at the time of heat welding, and a discharge port member 9 is attached to the end seal 8. Connecting cylinder member 1
1 and the outlet member 9 are made of an injection molded product made of polyethylene. One open end 17 of the connecting cylinder member 11 is disposed inside the main body 2, and a connecting port 13, which is another open end, is disposed outside the main body 2, and a hook jaw 18 is formed on the connecting port 13. The elastic ring material 14 and the sterilizing filter 1 are provided in the hook jaw 18.
5 are arranged. The mouth 4 of the medicine container 4 as shown in FIG.
When A is inserted into the hook jaw 18, the mouth 4 </ b> A comes into contact with the elastic ring member 14, and the inside of the medicine container 4 and the connecting member 11 are connected.
The inside is connected in a liquid-tight manner. At the time of storage, as shown in FIG. 1, when the mouth 4A of the medicine container 4 is not connected to the connection port 13, the protective sealing material 16 is hermetically attached to the connection port 13. A single isolation seal portion 12 is formed in the main body 2,
The isolation seal portion 12 divides the container body 2 into two chambers.
The chemical solution 3 is accommodated in the accommodation chamber 2 </ b> A, and the chemical solution 3 is prevented from contacting the connecting cylinder member 11 by the isolation seal portion 12. A rubber stopper for closing is provided in the discharge port member 9, and the chemical solution 3 is stored in the storage chamber 2 </ b> A in a liquid-tight manner.
The chemical solution 3 and the sterilization filter 15 are subjected to high-pressure steam sterilization together with the main body 2.

The drug solution 3 is a solution of the drug 5 in the container 4 connected to the connection port 13, and has been sterilized as described above. The isolation seal portion 12 is a heat-sealing seal portion. The heat sealing temperature of the isolation seal portion 12 is 140
C. or lower, and the heat sealing temperature of the end seals 7 and 8 of the main body is 160 C. or higher. For this reason, the separating seal portion 12 is formed as a peelable peel seal, and the end seals 7 and 8 are formed as a fixed seal that breaks the container wall when the forcible peeling is attempted. The elastic ring member 14 is made of silicone rubber and is called an O-ring. The sterilizing filter 15 has a pore size of 0.
It consists of a 22 μm hydrophilic filter. As shown in FIG. 3, the sterilizing filter 15 has a peripheral edge 15A subjected to a hydrophobic treatment, and a hydrophobic filter portion from which air is removed is formed on the peripheral edge 15A. The protective sealing material 16 is made of a mixed paper containing polypropylene fibers, and has an air permeability of 20 seconds / 100 ml. For this reason, after the high-pressure steam sterilization of the main body 2,
1 can be easily removed.

The medical container 1 constructed as described above comprises a resin container main body 2, a connecting cylinder member 11, an elastic ring, and a sterilizing filter, and is limited to a very small number of parts. In addition, there is no sliding or sliding member in these parts. Therefore, the medical container 1 is easy to assemble, and can be easily connected to another medicine container 4. Further, by providing the gas-permeable protective sheet 16 at the connection port 13 of the connection cylinder member 11, the sterilization filter 15 can be steam-sterilized together with the chemical solution 3 of the main body 2, and can be kept clean until storage. it can. Then, the sterilization filter 1 is formed by forming the isolation seal portion 12.
5 does not soak in chemicals until its use. For this reason,
There is no risk of deterioration during storage. When using the medical container 1, the protective sheet 15 is peeled off from the connection port 13, and the mouth 4A of the medicine container 4 is inserted into the connection port 13,
The medicine container 4 is connected to the connecting cylinder member 11. Next, the container body 2 is pressed by hand or the like to peel off the isolation seal portion 12,
The drug solution 3 is poured into the connecting cylinder member 11, and the drug in the drug container 4 is dissolved by the drug solution 3. After dissolving and returning the chemical solution 3 again, a drip communication needle is inserted into the outlet member 9 to start drip infusion. Therefore, co-infusion and infusion operations can be extremely easily performed. In the first embodiment, the protective sheet 15 is attached to the connection port 13, but as shown in FIG. 2, the medicine container 4 is attached to the connection port 13 in a sterile room or the like in advance and provided as a full kit medical container. Is also good. In the first embodiment, the blown film is used for the container body 2, but a blow molded product may be used for the container body. In the above embodiment, the medical container 1 is used as a bag for infusion. However, the medical container 1 may be used as a bag for dialysate, a bag for storing organs, and the like. In addition, you may package the connection part of the said Example with the packaging body of a gas barrier.

[0019]

As described above, the medical container according to the present invention is a resin main body containing a drug solution, and is used for connecting a drug container containing a drug mixed with the drug solution. A main body having a connecting portion, a separating seal portion is formed on the main body, the separating seal portion separates the storage portion for the chemical solution from the connecting portion, and the separating seal portion is a peelable seal portion. An elastic ring material and a sterilization filter are provided at the connection port of the connection section, and the connection port and the mouth of the medicine container can be liquid-tightly connected via the elastic ring material and the sterilization filter. Easy installation, high aseptic maintenance and safety of connecting part, and co-injection when using,
Mixing operation can be easily performed.

[Brief description of the drawings]

FIG. 1 is a front view of a first embodiment of a medical container according to the present invention.

FIG. 2 is a front view in which a medicine container is attached to the medical container of the first embodiment.

FIG. 3 is a plan view of a sterilization filter used in the medical container of the first embodiment.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Medical container 2 Resin container main body 3 Chemical solution 4 Drug container 5 Drug 11 Connecting cylinder member 12 Isolation seal part 14 Elastic ring material 15 Disinfection filter

Claims (3)

[Claims] 1. A resin body containing a chemical solution,
In a medical container comprising a main body having a connecting portion for connecting a medicine container containing a medicine mixed with the medicinal solution, an isolating seal portion is formed in the main body, and the medicinal solution housing portion is formed by the isolating seal portion. The connecting portion is separated from the sealing portion, and the separating seal portion is formed as a peelable seal portion.An elastic ring material and a sterilization filter are provided at a connecting port of the connecting portion. A medical container capable of being connected in a liquid-tight manner via an elastic ring material and a sterilization filter. 2. The method according to claim 1, wherein a protective sealing material is hermetically adhered to the connecting port, the protective sealing material is made of a breathable sheet, and the inside of the connecting portion is steam sterilized together with the inside of the container body. The medical container according to claim 1. 3. The medical container according to claim 1, wherein the other medicine container is already provided at the connection port, and the inside of the medicine container communicates with the inside of the main body.