JPH0349472B2 - - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION Background of the Invention (1) Technical Field The present invention relates to medical instruments. More specifically, the present invention relates to a plastic medical device containing a medicinal solution, such as a blood bag or an infusion bag, which stores a medicinal solution and is further packaged.

(2) Prior art and its problems Plastic medical instruments such as blood bags and infusion bags contain anti-coagulants such as ACD liquid and CPD liquid, and the action of the anti-coagulant makes it difficult to collect blood. Prevents blood from clotting during blood transfusions or blood transfusions.

However, medical instruments containing such medicinal solutions are stored in airtight storage containers made of synthetic resin, but due to the nature of the plastic used in medical instruments, the internal contents inevitably leak. Moisture in the chemical solution stored in the device permeates through the device wall and onto the surface. For this reason, when such medical devices are packaged, the inside of the flexible bag becomes highly humid, so if microorganisms are attached to the surface of the medical device during the period from manufacture to use. , there is a risk of proliferation.

Therefore, a medical packaging container has been proposed in which an oxygen absorber is housed in a sealed container to prevent the growth of microorganisms (Japanese Patent Publication No. 18066/1983).

The above-mentioned packaging container uses a bag-like product made by overlapping two polyester resin sheets, vapor-depositing aluminum on opposing surfaces, and heat-sealing the periphery with a hot-melt adhesive.

However, the above-mentioned bag-like materials have poor shape retention, making them inconvenient to store, and when stacked up during storage or transportation, they collapse, which may have a negative effect on the contents.

Therefore, packaging containers using three-dimensional objects have been proposed (Japanese Unexamined Patent Publication No. 192551/1983;
−192552).

The above packaging container is formed by a three-dimensionally molded tray and a lid that seals the upper opening.
Although they are sufficiently effective, the medical instruments may move inside the tray during transportation, which may cause pinholes to form in the medical instruments, or the tubes attached to the medical instruments may become twisted and entangled. It could be time consuming to do so.
Furthermore, if an impact is applied to the lid during transportation or storage, there is a risk that pinholes may be formed at or near the fused portion between the lid and the tray.

OBJECT OF THE INVENTION Therefore, an object of the present invention is to solve the problems of the prior art described above, and to prevent medical instruments from being crushed even when stacked during storage or transportation, and to prevent medical instruments from being crushed inside the packaged state. It does not move, so pinholes do not occur in medical instruments, tubes attached to medical instruments do not twist and become entangled, and pinholes do not occur even if shock is applied during transportation or storage. An object of the present invention is to provide a plastic medical device containing a medicinal solution packaged without the risk of malfunction.

The above object is achieved by: a cage-like tray that is open at the top and has a shape-retaining property and has a storage space for a plastic medical device containing a medical solution; an oxygen absorber stored in the tray; A plastic medical device containing a medical solution is stored in the storage space of the tray, and a plastic container is sealed to completely surround the tray that is impermeable to gas and water vapor. and a flexible bag, the flexible bag having a size that allows the medical instrument to come in contact with the opening of the tray in a sealed state, and further, the inside of the flexible bag is A packaged medical fluid-filled plastic medical device under reduced pressure, the flexible bag contacting the medical device at the opening of the tray and pressing the medical device against the bottom side of the tray. It is a tool for

Preferably, the inside of the flexible bag is in a reduced pressure state by absorbing oxygen inside the flexible bag by the oxygen absorber. Further, it is preferable that the interior of the flexible bag is sealed under a reduced pressure state, thereby being in a reduced pressure state.
Furthermore, it is preferable that the degree of pressure reduction is 700 to 300 mmHg. Preferably, the flexible bag is sealed by sealing the opening of the flexible bag above the opening of the tray.
Further, the flexible bag has a length from the opening of the tray to the end of the flexible bag above the opening.
It is preferable that it is not less than cm. The flexible bag is preferably made of flexible plastic coated with a resin that is hardly permeable to gas and water vapor. Furthermore, it is preferable that the resin having low gas and water vapor permeability is polyvinylidene chloride or ethylene-vinyl alcohol copolymer. Furthermore, the flexible bag
It is preferable that the material has transparency. Further, it is preferable that the tray is transparent. At least one surface of the oxygen absorber is covered with a breathable sheet, and the oxygen absorber is stored so that the breathable sheet side is located on the inner surface of an oxygen absorber storage section provided on the inner surface of the tray. Furthermore, it is preferable that the inner surface of the storage part has at least one groove communicating with the inside of the tray.

DETAILED DESCRIPTION OF THE INVENTION The medical instrument of the present invention will be described with reference to FIGS. 1 to 4.

An example in which a plastic medical container containing a drug solution is used as a medical device will be described below.

The packaged medical device made of plastic containing a medical solution of the present invention comprises a basket-like tray 1 which is open at the top and has a shape-retaining property and has a storage space 4 for storing a plastic medical device containing a medical solution inside the tray 1. an oxygen absorber 6 stored in the tray 1, and a plastic medical instrument 3 containing a medical solution stored in the storage space 4 of the tray 1.
and a flexible bag 2 which is gas and water vapor permeable and is sealed so as to completely enclose the tray 1 containing the medical instruments 3. In this state, the flexible bag 2 has a size that allows it to come into contact with the medical instrument 3 at the opening of the tray 1, and furthermore, the inside of the flexible bag 2 is in a reduced pressure state, and the flexible bag 2 is placed in the opening of the tray 1. The tray 1 contacts the medical instrument 3 and presses the medical instrument 3 against the bottom side of the tray 1.

Medical container 3 used in the medical device of the present invention
A container made of plastic (e.g., soft vinyl chloride resin, ethylene-vinyl acetate copolymer) contains a chemical solution; for example, ACD-A solution (e.g., an aqueous solution) 100
Sodium citrate 2.20g, citric acid 0.80 per ml
g and glucose (containing 2.20 g), CPD liquid (e.g.
Sodium citrate 2.63g, citric acid 0.327g, sodium dihydrogen phosphate 0.251 in 100ml of aqueous solution
blood bags containing anti-coagulants such as 2.3g of glucose (containing 2.32g of glucose), infusion bags containing medicinal solutions such as infusions, and tubes, connectors, syringes, etc. that are molded integrally with these or used in conjunction with them. There are some items that include the following accessories as a set.

As shown in FIGS. 2 and 3, the tray 1 used in the medical device of the present invention is a cage-like object having a certain depth with an open upper part, and a tray 1 used for the medical device 3 made of plastic containing a drug solution. It has a storage space 4 and an oxygen absorber storage section 5 on the inner surface. The depth of the tray 1 is selected appropriately depending on the size and quantity of medical containers to be stored. The oxygen absorber storage section 5 is
This is a recess formed on the bottom surface of the tray 1. Furthermore, a groove 7 communicating with this recess is provided.
Further, the oxygen scavenger storage section may be provided on the inner wall surface of the tray 1. Furthermore, instead of forming a recess, a rib may be provided that surrounds a part of the inner surface and projects inward of the tray, and the inside thereof may be used as an oxygen scavenger storage area. Further, it is preferable to provide a flange around the periphery of the opening of the tray 1.

By making the opening of the tray 1 a flange instead of an edge, no pain is caused to the fingers even when the fingers are placed over them when handling medical instruments. Moreover, it is preferable that the tray 1 has appropriate strength and shape retention. Strength is to ensure that the material does not break easily during transport and transportation, and shape retention is to ensure that it is not easily deformed during handling. Furthermore, it is preferable that the tray 1 has transparency.
This is because the contents of the medical container can be easily confirmed. The material of the tray 1 may be any material as long as it has a certain degree of strength and hardness, such as vinyl chloride resin, polypropylene resin, polyester resin, polystyrene/polypropylene resin, etc. Those having transparency are more preferable.

Flexible bag 2 used in the medical device of the present invention
is a medical container 3 whose inner surface is the opening of the tray 1.
surface that can be contacted. In other words, the flexible bag 2 surrounds the entire tray 1 and is sealed, leaving room above the opening of the tray 1.
Furthermore, the flexible bag 2 has low gas permeability and low water vapor permeability. Poor gas permeability preferably means that the gas (oxygen) permeability is 6.0cc/ ^m2 .
24hrs・atm (20℃, DRY) or less, and water vapor permeability of 3.0g/m ²・24hrs (40℃, 90%RH) or less. More preferably, the gas (oxygen) permeability is 1.0cc/ ^m2・24hrs・atm (20℃, DRY) or less,
Water vapor permeability is 1.0g/ ^m2・24hrs (40℃, 90%
RH) or less. Furthermore, the flexible bag 2 has a tensile strength of 10 kg/15 mm or more and a tensile elongation of
80% to 150%, puncture strength of 1500 g or more, tear strength of 10 to 150 g, bursting strength of 5 kg or more, and heat sealability of 3.0 kg/15 mm width (sealing temperature 140° C.) or more. Furthermore, it is preferable that the flexible bag 2 has transparency. This is because the contents of the medical container can be easily confirmed. Such a flexible bag 2 may be made of, for example, a flexible synthetic resin whose surface is coated with a resin (e.g., polyvinylidene chloride, ethylene-vinyl alcohol copolymer) having low gas permeability and low water vapor permeability. can be used suitably. The thickness of the coating is preferably 30 to 70 μm. As the flexible synthetic resin, for example, polyethylene terephthalate, polyethylene (preferably oriented polyethylene), polypropylene (preferably oriented polypropylene), etc. can be used. High adhesive properties are preferred. The thickness is 30 to 100 μm, preferably 35 to 60 μm, and transparent ones are more suitable.

As a more preferable form of the flexible bag 2, the outer surface of a flexible film such as polyethylene terephthalate, stretched polyethylene, or stretched polypropylene is coated with a resin having low gas permeability and low water vapor permeability (for example, polyvinylidene chloride, ethylene-vinyl alcohol copolymer) and an impact-resistant resin layer (e.g.,
Stretched polyamide) and further laminated with a hot-melt adhesive layer (e.g., low-density polyethylene) to improve heat-sealability via an adhesive, oriented polyethylene, oriented polypropylene, etc. The outer surface of the flexible film is coated with a resin having low gas permeability and low water vapor permeability (e.g., polyvinylidene chloride, ethylene-vinyl alcohol copolymer), and the outer surface is coated with high-density polyethylene and/or polyethylene. It is made by laminating terephthalate and further laminating a hot-melt adhesive layer (for example, low-density polyethylene) on the inner surface.

The flexible bag 2 has an opening for putting the tray 1 containing the medical container therein, and after storing the tray 1, the opening is fused using heat, ultrasound, high frequency, etc. 9 is formed and sealed. Further, sealing may be accomplished by using an adhesive, but preferably by fusion as described above.

A notch 10 is provided at the end of the flexible bag 2 located above the opening of the tray 1 so that the flexible bag 2 can be opened easily. Furthermore, the flexible bag is sealed by sealing the opening at the top of the opening of the tray, the sides or the bottom of the tray.

Further, the flexible bag 2 accommodates the tray 1 with a space above the opening of the tray 1, and is sealed. Thus, the inner surface of the flexible bag 2 can come into contact with the surface of the medical container 3. This is done when the oxygen inside the flexible bag is absorbed by the oxygen scavenger described later and the inside becomes negative pressure.
Alternatively, when the inside of the flexible bag is depressurized in advance, the flexible bag 2 in the upper part of the tray 1 is recessed toward the inside of the tray 1 and presses the stored medical container toward the bottom of the tray 1. This is because the attached medical container can be prevented from moving.

Further, it is preferable that the length of the flexible bag 2 from the opening of the tray 1 to the end of the bag above the opening is 4 cm or more. Specifically, the sealed end of the flexible bag 2 and the top of the tray 1 are separated by a folding margin of 4 cm or more, preferably 6 cm or more when the flexible bag 2 is stretched out. 8 is preferably formed. This means that when the medical device of the present invention stores a plurality of medical containers,
If you don't use it all at once, fold it 8
This is because by bending the medical instrument, dust and the like can be prevented from falling onto the surface of the medical instrument.

Next, the oxygen absorber 6 used by being stored in the oxygen absorber storage section 5 of the tray 1 of the medical instrument of the present invention is as follows:
To absorb oxygen in the space between the packaged medical device and the flexible bag (inside the flexible bag) and prevent the growth of microorganisms such as mold, and to prevent the inside of the flexible bag. is used to apply a negative pressure to the flexible bag 2 in the upper part of the tray 1 and dent the flexible bag 2 inward of the tray 1, thereby pressing the medical container 3 toward the bottom of the tray 1 and preventing its movement. . Various oxygen absorbers 6 can be used, and one example is at least one selected from the group consisting of iron carbide, iron carbonyl, ferrous oxide, ferrous hydroxide, and iron silicon. Oxygen absorbent made of compound and metal halide (containing water if necessary) (Japanese Patent Laid-Open No. 37088/1988), Oxygen absorbent made of metal powder coated with metal halide (Japanese Patent Laid-Open No. 54-37088)
Publication No. 35189), etc. It is preferable that at least one surface of the oxygen absorber 6 is covered with a breathable sheet. Furthermore, it is preferable that one side is covered with an air-impermeable sheet. Then, the oxygen absorber storage portion of the tray 1 is arranged so that the breathable sheet side is located on the inner surface of the oxygen absorber storage portion 5 of the tray 1, and the non-breathable sheet is located on the medical container storage space 4 side of the tray 1. It is stored in 5. The groove 7 of the tray 1 is
This is provided to ensure that the air-permeable sheet side of the oxygen absorber 6 and the internal space of the tray 1 are always in communication.

Therefore, even when the medical container 3 is housed above the oxygen absorber 6, the oxygen absorber 6 functions reliably and can reliably absorb oxygen inside the flexible bag.

In addition, a hygroscopic sheet approximately the same size as the bottom surface of the tray 1, for example, Japanese paper 11, is placed on the top of the oxygen absorber 6.
It is preferable to provide This is because when the moisture in the medical container passes through the wall of the medical container and becomes water droplets in the tray 1 during storage, the washi paper 11 absorbs the water droplets, so the water droplets adhere to the oxygen absorber. This is because it is possible to prevent a decrease in oxygen scavenging ability caused by this.

Preferably, the inside of the flexible bag 2 containing the tray 1 containing medical containers is under reduced pressure. By reducing the pressure, the amount of oxygen inside the flexible bag can be reduced, and by using an oxygen absorber, the inside of the flexible bag can be deoxidized reliably, and even with a small amount of oxygen absorber. , the generation of microorganisms such as mold can be reliably prevented. Furthermore, the flexible bag 2 in the upper part of the tray 1 is recessed toward the inside of the tray 1 and presses the stored medical container toward the bottom of the tray 1 to reliably prevent the medical container from moving. be. The degree of reduced pressure is 700~300mm
Preferably it is Hg.

Next, an embodiment of the packaged medical solution-filled plastic medical device of the present invention will be described.

Example 1 The tray is made of vinyl chloride resin, has a flange around the upper opening, has a height of 110 mm, an upper opening length of 250 mm, a depth of 145 mm, a bottom length of 245 mm,
The depth is 135mm (the difference in length and depth between the top opening and the bottom is the flange size),
As shown in FIG. 3, the bottom surface had a recessed oxygen absorber accommodating part and a groove communicating with the accommodating part.

The flexible bag has a shape as shown in Figure 4, with a length of 385 mm, a width of 230 mm, and a side gusset width A.
I made a 75mm one. The material of the flexible bag is a polyethylene terephthalate flexible film coated with polyvinylidene chloride on the outer surface, and stretched polyamide (approximately 15 μm in thickness) laminated on the inner surface with an adhesive. The lower part,
And the sides were heat-sealed to form a bag. Furthermore, a notch was provided at the bottom end.

The oxygen permeability of this flexible bag is 1.90cc/ ^m2 .
24hrs・atm (20℃, DRY), water vapor permeability is 0.55
g/ ^m2・24hrs (40℃, 90%RH), tensile strength 11.5
Kg/15mm width, tensile elongation 102.5%, puncture strength 2140g,
The tear strength was 85g, the burst strength was 8.1Kg, and the heat sink property was 10.9Kg/15mm width (sealing temperature 140°C).

Place an oxygen absorber (manufactured by Mitsubishi Gas Chemical Co., Ltd., trade name: Ageless), which is covered with a breathable sheet on one side and a non-breathable sheet on the other side, in the oxygen absorber storage area of the tray. I stored it so that it was on the bottom side. Furthermore, a piece of Japanese paper approximately the same size as the bottom of the tray was placed on top of the oxygen absorber, and 10 blood bags (double plasmapheresis blood bags for blood collection) were placed on top of it.

At this time, the distance between the upper end of the blood bag and the opening of the tray was approximately 12 mm.

Then, place the tray containing the blood bags into a flexible bag, making sure not to leave too much air inside the bag, heat-sealing the opening of the flexible bag with the bottom of the tray, and making a notch at the end. A packaged medical solution-filled plastic medical device of the present invention having the following properties was prepared.

At this time, the flexible bag had sufficient space above the opening of the tray, and when the top of the flexible bag was pressed down, the inner surface came into contact with the medical container. Further, the length (folding margin) from the opening of the tray to the flexible bag on top was 40 mm. When the packaged medical instruments were left as they were for about 24 hours, the oxygen absorber absorbed the oxygen inside the flexible bag and created a negative pressure, causing the flexible bag to move inside the opening of the tray. He was holding down a dented medical container. At this time, even if the packaged medical device was shaken, the medical container inside did not move easily.

Furthermore, when the opening of the tray was pushed open and deformed from the outside, the flexible bag expanded at the top of the tray, and no undue force was applied to any part of the tray.
Therefore, it seemed to have sufficient impact resistance. Moreover, the flexible bag could be easily opened by tearing the flexible bag through the notch. Furthermore, after taking out about half of the medical container, the flexible bag could be easily sealed by folding the folding margin.

Example 2 As the material for the flexible bag, polyvinylidene chloride was coated on the outer surface of a flexible film made of stretched polypropylene, and stretched polyamide (approximately 15 μm in thickness) was laminated on the inner surface with an adhesive. ,
Low density polyethylene (thickness approx.
70μ) laminated (total thickness approx.
121μ) was used. The oxygen permeability of this flexible bag is
2.90cc/ ^m2・24hrs・atm (20℃, DRY), water vapor permeability is 0.49g/ ^m2・24hrs (40℃, 90%RH),
Tensile strength 12.8Kg/15mm width, tensile elongation 93.0%, puncture strength 2270g, tear strength 75g, bursting strength 9.1Kg, heat sealability 10.1Kg/15mm width (sealing temperature 140
℃). A packaged medical device was prepared in the same manner as in Example 1 except for the flexible bag. The flexible bag had sufficient space above the opening of the tray, and when the flexible bag was pressed, the inner surface came into contact with the medical container. The folding allowance was 45mm. When this packaged medical device was left as is for about 30 hours, the flexible bag dented inside the opening of the tray and pressed down on the medical container.

At this time, even if the packaged medical device was shaken, the medical container inside did not move easily.

Furthermore, when the opening of the tray was pushed open and deformed from the outside, the flexible bag expanded at the top of the tray, and no undue force was applied to any part of the tray.
Further, as in Example 1, it was possible to seal easily using the folding margin.

Example 3 Using the same material as in Example 1, the inside of the flexible material was further reduced in pressure, and then sealed and packaged to produce a medical device. The degree of pressure reduction was 600 mmHg. When this packaged medical device was manufactured, the flexible bag was recessed inside the opening of the tray and pressed against the medical container. Even when the packaged medical instruments were shaken, the medical instruments inside did not move easily. Furthermore, when the opening of the tray was pushed open and deformed from the outside, the flexible bag expanded at the top of the tray, and no undue force was applied to any part of the tray. Further, as in Example 1, it was possible to seal easily using the folding margin.

Comparative Example A packaged medical device was produced using the same flexible bag as in Example 1, except that the length of the flexible bag was 350 mm.

The flexible bag had almost no clearance above the opening of the tray, and even when the flexible bag was pushed, it did not come into contact with the medical container. Also, there was no folding margin at all.

The packaged medical instruments were left as they were for about 24 hours, but the flexible bag hardly dented inside the opening of the tray, and when the packaged medical instruments were shaken, the medical containers inside were removed. moved freely.

Furthermore, when the opening of the tray was forced open from the outside to forcefully deform it, pinholes were formed in the heat-sealed portion of the upper portion of the tray in the flexible bag.

Specific Effects of the Invention The present invention provides a shape-retaining basket-like tray that is open at the top and has a storage space for plastic medical instruments containing a medical solution inside, and an oxygen scavenger stored in the tray. , a medical device made of plastic containing a drug solution stored in the storage space of the tray, and a plastic medical device that is impermeable to gas and water vapor, and is sealed so as to completely surround the tray that stores the medical device. a flexible bag, further, the flexible bag has a size that allows contact with the medical instrument at the opening of the tray in a sealed state, and further, the interior of the flexible bag is under reduced pressure, and the flexible bag is in contact with the medical device at the opening of the tray, pressing the medical device against the bottom side of the tray. This is a medical device that uses shape-retentive trays, so it will not collapse even when stacked up during storage or transportation.Furthermore, the oxygen absorber contained in the bag absorbs the oxygen in the flexible bag. As a result, the interior of the flexible bag becomes a negative pressure state (decompression state), and the flexible bag in the upper part of the tray is recessed toward the inside of the tray, pressing the medical instruments toward the bottom of the tray. Medical instruments do not move inside the flexible bag, thereby preventing pinholes from forming in the medical instruments, and tubes attached to medical instruments from twisting and becoming entangled.
Furthermore, even if a shock is applied during transportation or storage, the impact is absorbed by the looseness of the flexible bag, thereby eliminating the possibility of pinholes forming in the flexible bag.

[Brief explanation of drawings]

FIG. 1 is a perspective view showing an embodiment of the packaged medical solution-filled plastic medical device of the present invention, and FIG. 2 is a longitudinal cross-sectional view of the present invention shown in FIG. 1 with the medical container portion omitted. FIG. 3 is a plan view showing an example of a tray used in the present invention, and FIG. 4 is a diagram showing an example of a flexible bag used in the present invention. 1...Tray, 2...Flexible bag, 3...Medical container, 4...Medical container storage space, 5...Oxygen absorber storage section, 6...Oxygen absorber, 7...Groove, 8... Folding allowance, 9... Fusion part, 10... Notch, 11
……Japanese paper.

Claims (1)

[Scope of Claims] 1. A cage-like tray with shape retention properties that is open at the top and has a storage space for a plastic medical device containing a medical solution therein; an oxygen absorber stored in the tray; A plastic medical instrument containing a medical solution is housed in the storage space of the tray, and a flexible plastic sheet that is impermeable to gas and water vapor and is sealed so as to completely surround the tray that houses the medical instrument. furthermore, the flexible bag has a size that allows contact with the medical instrument at the opening of the tray in a sealed state, and the interior of the flexible bag is under reduced pressure. the flexible bag is in contact with the medical instrument at the opening of the tray;
A packaged plastic medical device containing a medical solution, characterized in that the medical device is pressed against the bottom side of the tray. 2. The packaged medical solution-containing plastic according to claim 1, wherein the inside of the flexible bag is in a reduced pressure state by absorbing oxygen inside the flexible bag by the oxygen scavenger. Made of medical equipment. 3. The packaged plastic medical device containing a medicinal solution according to claim 1, wherein the inside of the flexible bag is sealed under a reduced pressure state so as to be in a reduced pressure state. 4. The packaged plastic medical device containing a medical solution according to claim 2 or 3, wherein the degree of pressure reduction is 700 to 300 mmHg.