JPS62286463A - Package container housing medical instrument - 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 ■ Background Technical Field of the Invention The present invention relates to packaging containers for storing medical devices such as blood bags, and particularly to packaging containers for medical devices that require prevention of mold growth and deterioration during packaging. It depends.

Prior Art Medical devices such as blood bags, arterial blood collection devices, liquid syringes, blood transfusion containers, cases, hypodermic needles, vacuum blood collection tubes, etc. are made into products by pasting labels indicating the required information, and are collected in a predetermined number. It is stored and distributed in a packaged state. Naturally, medical device products packaged in this manner must be stored in a sanitary manner until the packaging is opened, and in particular, they must be completely free of mold. For this reason, it goes without saying that great care must be taken in the process up to product packaging, and various anti-mildew measures have been employed in the past.

The first method is to sterilize the labeled medical device product in an autoclave or the like at low temperature (bathurization).
In addition, it should be sealed and packaged using a material with excellent airtightness, such as aluminum foil. This means is not only for the purpose of preventing mildew, but is also the most basic means for killing various pathogenic bacteria and various germs and preventing their invasion and proliferation.

However, this basic measure alone cannot completely prevent mold from forming, and when the product is opened after long-term storage, mold is often observed, especially near the label attached to the surface of the product. This is because heat-resistant spores that were not killed by Bassurizacidin germinate during storage and propagate using the glue used to attach the label as a medium. At that time, as is well known, molds can easily utilize water with a low water activity value and breed.
The more moisture there is for some reason, the more likely mold will develop. For example, blood bags contain an anticoagulant solution and are particularly susceptible to mold formation, as moisture from this solution leaches to the surface during bathization or subsequent storage. Additionally, when steam sterilization is used, steam may enter the instrument during bathization, and this steam may diffuse out of the instrument after packaging, creating a moisture-rich atmosphere. Therefore, in such cases, a packaging container structure has been adopted in which the inner wall of the packaging container is covered with a water-absorbing sheet such as Japanese paper so that the water that has leached or diffused is absorbed and removed from the culture medium environment. There is.

The second method is to seal an oxygen absorber in the packaging container together with the medical device to remove molecular oxygen within the packaging container. This anti-mold method is often used in combination with the first method, in which case an oxygen scavenger is enclosed together with the medical instruments in the storage space surrounded by the water-absorbing sheet.

The anti-mildew effect of this oxygen scavenger is due to the fact that the type of fungi that cause the above-mentioned mildew are aerobic fungi. That is, the redox reaction of the cytochrome enzyme system, which is a basic life reaction of aerobic bacteria, uses molecular oxygen as the final acceptor of electrons. Therefore, by forming an anaerobic atmosphere in which molecular oxygen does not exist, the biological reactions can be stopped and mold generation can be prevented. Incidentally, since the process up to packaging, such as bus tourism, is carried out in the air, there is no need to consider mold generation by obligate anaerobic fungi.

Problems with the Prior Art Conventional packaging containers that use both the first and second anti-mildew means have the following problems.

That is, when moisture is released from inside the packaged medical device as described above, the moisture condenses and adheres to the surface of the oxygen scavenger. As is well known, oxygen scavengers are made of substances that easily react with water, such as iron powder and metal halides, so the oxygen scavengers react with this condensed water and are destroyed, resulting in the deoxidation of molecular oxygen, which is its original function. Absorptive capacity deteriorates rapidly. In that case, the desired anaerobic atmosphere cannot be formed within the packaging container, and mold growth cannot be prevented.

■ Purpose of the Invention In view of the above-mentioned circumstances, the purpose of the present invention is to fully utilize the function of the oxygen absorber when using an oxygen absorber to prevent mold from forming in the packaging of medical devices, so that the interior of the package remains virtually intact until the package is opened. To provide a hygienic packaging container that can be maintained in an oxygen-free state and prevent mold growth.

The above object is to provide a packaging container for medical devices that includes a sealable container body made of a gas-impermeable material, and a water-absorbent sheet that covers the inner surface of the container body and has a peripheral edge affixed to the inner surface of the container body. This is achieved by comprising a pouch containing an oxygen scavenger sealed in a gap between the water-absorbing sheet and the container body.

As the oxygen scavenger-containing pouch, a commonly available pouch containing an oxygen scavenger material can be used, and the pouch has a breathable film on one side and a non-breathable film on the other side. In this case, it is preferable to arrange the pouch so that the air-permeable film side faces the inner surface of the container body, and the non-air-permeable film side of the pouch faces the water-absorbent sheet. More preferably, the oxygen scavenger-containing pouch of the general form described above is used by folding it in two so that the non-breathable film is on the outside.

As is clear from the foregoing, the packaging container of the present invention can be used to package a medical device with a label affixed to its surface, particularly a medical device containing an aqueous drug solution inside, such as a blood bag. It is particularly effective.

■Detailed Description of the Invention The present invention will be specifically described below based on an embodiment shown in the drawings.

FIG. 1 shows a packaging container 1 configured for packaging blood bags.
FIG.

In the figure, 11 is a sealable container body made of a gas-impermeable material. A water absorbent sheet 12 is disposed inside the container body. The water absorbent sheet 12 is disposed to cover substantially the entire inner surface of the container body 11, and is adhered to the inner surface of the container body 11 at an annular seal area 13 near the opening. As long as the water-absorbing sheet 12 can maintain a state in which substantially the entire inner surface of the container body 11 is covered, it is preferable that the seal area 13 be as small as possible. Furthermore, a pouch 20 containing an oxygen absorber is sealed in the gap between the container body 11 and the water absorbent sheet 12.

In this embodiment, the container body 11 is made of an aluminum bag,
It has an opening for storing a blood bag. Aluminum bags have advantages such as high ability to block the invasion of bacteria from the outside, good heat conduction during sterilization, and excellent water resistance, so they are used as packaging materials for medical devices such as blood bags. Are suitable. In this embodiment, the aluminum bag used is an aluminum foil with plastic films laminated on both sides and sealed into a bag shape.

However, the configuration is not particularly limited to this.

Like the container body 11 described above, it is common practice to make a bag from a single sheet, and the bag is made by sealing the necessary parts of the sheet. In that case, if at least one side of the sheet is made of a heat-sealable plastic film such as polyethylene, it can be easily formed into a bag by heat-sealing using its heat-sealing properties. In this example, a three-layer laminate film of stretched polyester film/aluminum foil/polyethylene film was used, and a container body 11 made of an aluminum bag was created by heat sealing.

In this embodiment, the water-absorbing sheet 12 is made of Japanese paper that easily absorbs water vapor, and the surface facing the inner surface of the container body is coated with a synthetic resin coating layer having pores that allow gas to pass through but not water droplets. covered with. The coating layer is preferably a polyethylene layer having pores of size 083-t and about omIR. In this example, 43
Using Japanese paper with a thickness of approximately 70μ, the coating layer has a thickness of 20μ and a pore size of 0.3 to 0.
A polyethylene layer with a thickness of 5 mm and a pore spacing of 1.4 mm was used.

In order to adhere the water absorbent sheet 12 to the container body 11 in the seal area 13, the water absorbent sheet 12 may be formed into a bag shape that fits inside the container body 11, and a predetermined area thereof may be adhered. However, in this embodiment, since a polyethylene coating layer was used for the water absorbent sheet 11, the container body 11
The water-absorbent sheet 12 is superimposed on the sheet before formation, and the sealing area 13 is heat-sealed to easily bond the sheet. Thereafter, if this is made into a bag by the method already described for the aluminum bag, all the adhesion necessary to obtain the container shown in FIG. 1 can be done by heat sealing, making it easy to manufacture.

In this embodiment, as the oxygen absorber-containing pouch 20, a generally commercially available pouch 20 can be used.
The figure shows an example of this in a state where two bags are connected. In the figure, 21 is an air-impermeable sheet such as aluminum laminated paper, and 22 is an air-permeable sheet such as perforated polyethylene laminate paper. An oxygen scavenger is stored in a pouch formed by stacking these two sheets and heat-sealing the peripheral edges. This small bag containing oxygen absorber 2
0 is stored in the gap between the container body 11 and the water absorbent sheet 12, the non-breathable sheet 21 is the water absorbent sheet 1.
It is preferable to face 2. More preferably, as shown in FIG. 3, the oxygen absorber-containing pouch 2o is folded in half and stored with the non-breathable sheet 21 facing outward.

The oxygen absorber is preferably a combination of iron powder or iron-based compound powder and a metal halide. but,
Any of the oxygen scavengers listed below may be used. In any case, these oxygen scavengers have the property of easily reacting with water and deteriorating their functionality.

(1) A combination of at least one iron-based compound such as iron carbide, iron carbonyl, ferrous oxide, ferrous hydroxide, iron silicide, etc., and a metal halide.

(2) Iron and/or zinc and Na2SO4・10
In combination with H20 or with the addition of metal halides.

(3) Iron, copper, tin, zinc and/or nickel
Na2 SO3・7H20 or Na 2CO3
Combination of 7H20 and metal halide.

(4) A combination of a transition metal of the fourth period of the periodic table, tin and/or antimony, and water or a halogenated metal.

(5) A combination of an alkaline earth metal sulfite and a ferrous oxide, a transition metal salt other than ferrous oxide, or an aluminum salt.

(6) A combination of an alkaline earth metal sulfite, a transition metal salt or an aluminum salt, an alkali metal or an alkaline compound containing an alkaline earth metal, and an alkaline compound containing nitrogen.

(7) Combinations of alkali metal or ammonium sulfites, bisulfites and (or pyrosulfites) with transition metal salts or aluminum salts.

(8) Combination of alkaline earth metal sulfite, ferrous salt compound, and ammonium salt.

(9) Combination of dithionite and water-containing alkaline earth metal hydroxide or carbonate.

(10) Combination of dithionite, activated carbon and water.

(11) Combination of dithionite and a compound having water of crystallization.

(12) Combination of dithionite, alkaline substance, and alcohol compound.

A blood bag as shown in FIG. 4 is housed in the packaging container 10 of the above embodiment. This blood bag 30 includes a bag body 31, a blood collection tube 32 communicating with the inside of the body, and discharge ports 33, 34, which are made of flexible synthetic resin such as polyvinyl chloride. Further, a blood sampling needle 35 is attached to the tip of the blood sampling tube 32. On the surface of the bag body 31, a label 36 for recording necessary information such as blood type and date of blood collection is attached via an adhesive such as glue, as described above. The adhesive layer becomes a growth medium for the mold.

When packaging the blood bag 30, it is first steam sterilized, then cooled (usually left at room temperature), a label is affixed, and then rolled up and wrapped around the blood collection tube 23 to make it compact. This is housed, for example, in units of five in the packaging container 10 of the above embodiment, and the opening is sealed and sealed. Inside the thus sealed packaging container, the oxygen scavenger in the pouch 20 absorbs molecular oxygen in the atmosphere, achieving anaerobic conditions. The specific reaction at that time differs depending on the type of oxygen scavenger, but for example, in the case of an oxygen scavenger made of iron or iron compounds, oxidation of ferrous iron to ferric iron is involved.

As a result of achieving an anaerobic atmosphere inside the packaging container 10, even if aerobic bacteria are present in the packaging container (including aerobic fungi that have subsequently germinated), those bacteria will be deprived of molecular oxygen. Growth is inhibited or the plant dies. Therefore, even if the label 36 is attached with an adhesive such as glue that can serve as a medium for mold growth, mold growth is prevented and sanitary conditions are maintained.

At the same time, oxidative deterioration of the anticoagulant contained within the blood bag is also prevented.

In the above embodiment, an aluminum bag is used as the container body 11, but the bag is not limited to this, and any bag can be used as long as it can maintain airtightness.

Furthermore, the present invention is not limited to packaging containers for blood bags as in the above-mentioned embodiments, but can be applied to packaging for various medical devices such as liquid medicine cylinders, infusion containers, and cased injection needles.

(2) Specific functions and effects of the invention As described above, the function of the oxygen absorber is extremely important in the packaging container for medical devices according to the present invention. Moreover, in the present invention, the oxygen scavenger is extremely effective due to its unique structure, and the anti-mildew effect is significantly improved. The reason is as follows.

As is clear from the structure shown in FIG. 3, in the present invention, the oxygen absorber-containing pouch 20 is stored in the gap between the container body 11 and the water-absorbing sheet 12, unlike the conventional example. Therefore, the water-absorbing sheet 11 takes precedence in adhering and absorbing moisture in the atmosphere inside the container, and the oxygen scavenger and the water-absorbing sheet do not compete on the same occasion as in the past.

That is, if the oxygen scavenger pouch 20 is stored in the same space as the medical instruments as in the conventional example, the water absorbent sheet 12
The surface of the oxygen scavenger pouch 20 and the surface of the oxygen scavenger pouch 20 provide substantially equivalent condensation surfaces for the condensation of moisture in the storage space. For this reason, the water absorbent sheet 12 cannot prevent water droplets from adhering to the surface of the oxygen absorber, and cannot prevent deterioration of the oxygen absorber. On the other hand, in the case of the packaging container of the present invention, in order for the moisture in the instrument storage space to combine with the oxygen absorber, it must pass through the water absorbent sheet 12, and the water absorbent sheet 12 must pass through the water absorbent sheet 12 before reaching the oxygen absorber. It will be absorbed by the sheet 12. Moreover, in the above embodiment, since the outer surface of the water absorbent sheet 12 is coated with a resin coating that does not allow water droplets to pass through, even if the water absorbent sheet 12
Even if condensed water droplets adhere to the inner surface of the oxygen scavenger, these water droplets will not enter the oxygen scavenger storage space. Therefore, a low moisture state in the storage space of the oxygen absorber-containing pouch 20 is maintained, and the oxygen absorber is protected from deterioration due to reaction with water.

As described above, in the present invention, deoxidation and deterioration of the agent due to water are avoided, and the original function of the oxygen scavenger, which is absorption and removal of molecular oxygen, is fully exhibited. On the other hand, as mentioned above, the water-absorbing sheet 12 is gas permeable and allows air to freely flow between both sides, so the oxygen scavenger absorbs the oxygen present in the instrument storage space without any problem and leaves the space in the instrument storage space. By creating an anaerobic atmosphere during the period, excellent anti-mildew effects can be obtained.

In addition, as explained in the example, the oxygen absorber-containing sachet 2
If the non-air permeable sheet 21 is arranged so as to face the water absorbent sheet 12, the deterioration prevention effect of the oxygen scavenger will be further improved.
improve. That is, even if water permeates through the water-absorbent sheet 12, with this arrangement, the permeated water will be blocked by the non-breathable sheet 21. The action of preventing water intrusion by the non-air permeable sheet 21 functions more effectively by folding the oxygen scavenger-containing pouch 20 in half as shown in FIG.

[Brief explanation of the drawing]

FIG. 1 is a perspective view showing an embodiment of the medical device packaging container according to the present invention in an unsealed state, FIG. 2 is a perspective view showing a pouch containing an oxygen absorber used therein, and FIG. FIG. 4 is an explanatory view showing a preferred arrangement of oxygen absorber-containing pouches in the packaging container shown in FIG. 1, and FIG. 4 is a plan view showing a blood bag as an example of a medical device to be housed in the packaging container shown in FIG. DESCRIPTION OF SYMBOLS 10... Blood bag packaging container, 11... Gas-impermeable container body, 12... Water absorbent sheet, 20... Oxygen absorber-containing pouch, 21... Impermeable sheet, 22...・
・Breathable sheet, 30...-Blood bag. Applicant's agent Patent attorney Takehiko Suzue

Claims (3)

[Claims] (1) A sealable container body made of a gas-impermeable material, a water absorbent sheet covering the inner surface of the container body with a predetermined gap, and a water absorbent sheet sealed in the gap between the water absorbent sheet and the container body. A packaging container body consisting of a pouch containing an oxygen absorber;
A packaging container housing a medical device, comprising: a liquid-filled medical device stored in the packaging container. (2) The oxygen absorber-containing pouch has one side covered with a breathable film;
A patent claim characterized in that the oxygen scavenger substance is housed in a small bag whose other side is a non-breathable film, and the breathable film side is placed facing the inner surface of the container body. A packaging container containing the medical device described in item (1). (3) The oxygen absorber-containing pouch has one side covered with a breathable film;
The oxygen scavenger substance is housed in a pouch with a non-breathable film on the other side, and the bag is folded in half so that the non-breathable film faces outside. A packaging container containing a medical device according to claim (1).