JP2904807B2 - Packaging method and package for medical materials - Google Patents

Description

Description: TECHNICAL FIELD The present invention relates to a method and a package for packaging a hydrolyzable special medical material having the property of being embedded in a living body and decomposing with water.

[Prior art] To pack a hydrolyzable medical material, if water enters the package, it deteriorates during storage. Therefore, it is packed in a state that does not contain moisture, and moisture enters from outside even during storage. Need not be. Further, since it is necessary to take out the medical material packaged in a sterile state from the bag at the time of operation or the like, it is necessary to keep the outside of the bag in a sterile state. Therefore, it is desired that the storage items be put in the inner bag of the double bag and that the outside of the inner bag be completely sterile.

Here, examples of the bacteria include Escherichia coli, Pseudomonas aeruginosa, staphylococci, hemolytic streptococci, Candida, albicans, and the like.

Conventionally, as a countermeasure, a method of manufacturing a sterile double package as disclosed in Japanese Patent Publication No. 64-6793 has been proposed. That is, the medical material is put in an inner bag made of a laminated metal foil sheet, and this inner bag is made of a gas-permeable, bacteria-impermeable material, and put in an outer bag laminated with a material that melts at a higher temperature than the inner bag. Heat seal only the outer bag. Then, the inner and outer surfaces of the inner bag are sterilized through the outer bag by sterilizing the entire outer bag, the sterilizing gas is removed under vacuum and dried, and finally the inner bag is heat-sealed from the outside of the outer bag at a low temperature. Was. By this method, the package can be freely transferred while the inner and outer surfaces of the inner bag remain sterile,
At the time of use, the outer bag was opened, the inner bag was taken out with tweezers, carried to the operating table, and the inner bag was opened and the packed medical material was used there.

[Problems to be Solved by the Invention] However, in the above-described conventional devices,
It is necessary to perform the work of putting the inner bag in the outer bag with the inner bag open, and at that time, there is a possibility that the stored items may fall from the inner bag. In addition, since the inner bag is sealed after the outer bag is sealed, an opaque material is usually used as the gas-permeable and bacteria-impermeable material, and the inner bag is sealed through the outer bag. Since it is not visible, it is difficult to reliably seal the opening of the inner bag, and there is a disadvantage that a sealing error easily occurs. As a countermeasure, it is necessary to use an outer bag made of an expensive transparent material.

Also, since the inner bag is open, there is a risk that the stored items may protrude from the inner bag during various operations such as sealing of the outer bag, sterilization, vacuum drying, etc. performed after putting it in the outer bag, and if it protrudes, In addition to the fact that the inner bag is not completely sealed, the protruding items are deteriorated by moisture entering through the outer bag, and have a drawback that they cannot be used. In order to prevent this, it was necessary to take great care to prevent the stored items from protruding from the inner bag.

Further, ethylene oxide gas or a mixed gas thereof used as a sterilizing gas is desirably removed after sterilization. At this time, when the mouth of the inner bag is pushed and closed by the outer bag, it is removed. In addition to the fact that it is difficult to see the state inside the outer bag, there is also a disadvantage that it is necessary to vent for a long time or exchange gas with an inert gas in consideration of safety. Similarly, when the mouth of the inner bag is closed by being pushed by the outer bag, sterilization gas is difficult to enter into the inner bag, and sterilization must be performed for a long time in consideration of safety.

On the other hand, in the above-mentioned conventional one, since it is necessary to seal only the mouth of the inner bag from the end of the outer bag, the heat melting temperature of the laminate material of the inner bag must be lower than that of the outer bag. It is necessary to provide a difference in the heat sealing temperature between the inner bag and the outer bag, and there is a drawback that a special combination of materials is required.

[Means for Solving the Problems] In order to solve the above-mentioned drawbacks of the prior art, each invention of the present application discloses a method in which a bag using a gas-permeable and bacteria-impermeable material in at least a part of its constituent material is used. A step of storing a degradable medical material and sealing the bag mouth to form an inner bag; at least a part of the constituent material is made of a gas-permeable and bacteria-impermeable material; To form a sealed inner bag by sealing the bag mouth; if necessary, gas sterilizing a double bag consisting of an inner bag and a middle bag; a metal foil material coated or laminated with a heat-adhesive resin Storing the inner bag storing the inner bag in the outer bag; gas sterilizing or drying the outer bag storing the inner bag and the inner bag; removing the sterilizing gas in the bag or removing another gas from the bag. Replacement process; outer bag bag opening inside bag An inner bag using a gas-permeable and bacteria-impermeable material for at least a part of its constituent materials, and a middle bag. The double bag consisting of a separate bag body is stored in an outer bag made of a metal foil material coated or laminated with a heat-adhesive resin, preferably an aluminum foil material, and the bag mouth is formed as a bag mouth of a middle bag. A package made of a special medical material integrally heat-sealed, whereby a sterilized double bag can be reliably obtained at low cost.

[Operation] According to the invention of the present application, the package of medical materials is first sealed in the inner bag, packed in the inner bag, sealed, and put in the outer bag, Sterilization, drying,
Sterilized gas is removed and the outer bag is sealed.

Embodiment An embodiment of the present invention will be described with reference to FIGS.

As shown in FIG. 1, the inner bag (1) contains, for example, collagen, polyglycolic acid, polylactic acid, caprolactone,
A hydrolyzable medical material (2) made of a homo- or copolymer such as P-dioxanone, which is embedded in the body and decomposed by water, is packaged. The medical material (2) to be packaged includes, for example, surgical sutures, staples, sponges, pins, artificial skin, hemostatic materials, artificial tendons, ligaments, sustained-release agents, blood vessels, and the like. Examples of the material of the inner bag according to the present invention include gas-permeable and bacteria-impermeable materials such as high-quality paper, Japanese paper, Tyvek (registered trademark), nonwoven fabric, paper / synthetic resin laminate, and paper / synthetic resin coating, polypropylene, A heat-sealing plastic film such as polyethylene, polyester, or polyamide is preferably used. At this time, the entire inner bag may be made of a gas-permeable and bacteria-impermeable material, or a part of the material may be used.

In the embodiment shown in FIG. 1, all the materials are made of a gas-permeable and bacteria-impermeable film. After storing the medical material (2) in the inner bag (1) made of such a material, the opening thereof is heat-sealed to form a heat-sealed portion (3) and seal it.

The inner bag (1) can be sterilized in this state in advance.

Next, the inner bag (1) is stored in the inner bag (4) as shown in FIG. The inner bag (4) is made of the same gas-permeable and bacteria-impermeable material as at least part of the inner bag (1). In the embodiment shown in FIG. An impermeable heat-sealable plastic film (5) is used, and a gas-permeable, bacteria-impermeable film (6) is used on the surface. Next, the opening of the inner bag (4) is heat-sealed and heat-sealed (7).
After forming a sealed double bag, the inner bag (4) is housed in an outer bag (8) made of a metal foil such as an aluminum foil coated or laminated with a heat-sealable resin.

A sterilizing gas such as ethylene oxide gas or a mixed gas thereof is supplied to the entire outer bag containing the double bag. This sterilized gas enters the inner bag (4) through the gas-permeable and bacteria-impermeable material through the opening of the outer bag (8), sterilizes the outer surface of the inner bag (1) stored therein, and further sterilizes the inner bag. The bag enters the inner bag through a gas-permeable and bacteria-impermeable material, and sterilizes the stored medical material (2) and the inner surface of the inner bag (1).
Next, degassing is performed by a vacuum device, and after discharging the sterilizing gas or simultaneously drying in a drying furnace,
Sterilized gas and moisture are removed from the outer bag (8), the inner bag (4) and the inner bag (1). Further, an inert gas or the like may be sealed in the bag if necessary.

Finally, the bag mouth of the outer bag (8) is completely heat-sealed and sealed. At this time, in consideration of convenience during use, the inner bag (4) is used.
A portion corresponding to the heat seal portion (7) is heat sealed to form a heat seal portion (9) in which both portions (4) and (8) are partially integrated. In addition, this heat seal part (9)
An opening notch (10) is formed near the lower end of the opening.

In the above embodiment, the entire outer bag is made of metal foil, but the outer bag (8) is made sufficiently longer than the inner bag (4).
Inner bag (1) or inner bag (4) at the part protruding from the inner bag (4)
A gas-permeable and bacteria-impermeable material portion made of the same material as above is adhered, and after storing the inner bag (4), the outer bag (8)
Is heat-sealed, and then sterilization, drying, and degassing are performed as described above. Then, the lower end of the material is heat-sealed, so that the outer bag (8) has a storage portion for the inner bag (4). Alternatively, the gas-permeable and bacteria-impermeable material may be prevented from communicating with the portion. Further, in this case, the heat seal portion may be cut off.

[Effects of the Invention] As described above, since the present invention seals the inner bag first, during various operations such as inserting the inner bag into the outer bag, the contents may fall as in the conventional case. Disappears. In particular, since the seal is finally the seal of the outer bag, the state of the seal can be clearly understood, and no sealing error occurs. Therefore, it is not necessary to use an expensive transparent material for the outer bag. Further, since the inner bag is sealed, the stored items do not protrude from the inner bag during various operations, and there is no occurrence of a defective seal or a defective product due to the conventional protrusion.

Furthermore, during sterilization, degassing, and drying operations, the inner bag, which had been opened as in the past, is crushed and closed, and this operation requires a lot of time in consideration of safety. Is eliminated and work efficiency is improved.
Moreover, it is also possible to sterilize the inner bag before putting it in the outer bag, in which case the final sterilization is secondary sterilization, especially since the inner bag is provided, the outer surface of the inner bag is completely sterilized. This improves the sterilization efficiency.

The inner bag is made of a gas-permeable and bacteria-impermeable material, and after inserting the inner bag into it, the bag mouth is sealed to form a double bag. Can be sterilized on the inner and outer surfaces, and after sterilization, the sterility of the inner bag can be maintained even under sterile conditions, so that subsequent handling becomes extremely easy.

Furthermore, since the sealing of the final outer bag seals the portion where the inner bag does not exist, there is no need to select a material that fuses the inner bag at a lower temperature than the outer bag as in the prior art. Since the same heat-sealing resin or the like can be used for both the inner bag and the outer bag, the cost is reduced.

And since the inner bag opening and the outer bag opening were heat-sealed integrally, when this was cut and opened at the cut, the inner bag opening and the outer bag opening were opened at the same time, and the inner bag could be taken out immediately, so surgery Workability at the time is not impaired.

When a gas-permeable and bacteria-impermeable part is used for a part of the outer bag, the part is heat-sealed and then cut off to reduce the size of the product and improve handling.

[Brief description of the drawings]

1 to 4 show an embodiment of the present invention. FIG. 1 is a front view of a part of the inner bag cut away, and FIG. 2 is a front view of a part of the inner bag storing the inner bag. FIG. 3 is a front view of a part of the outer bag accommodating the middle bag shown in FIG. 2, and FIG. 4 is a sectional view taken along the line AA of FIG. DESCRIPTION OF SYMBOLS 1 ... Inner bag 2 ... Medical material 3,7,9 ... Heat sealing part 4 ... Middle bag 5 ... Gas and bacteria impermeable film 6 ... Gas permeable and bacteria impermeable film 8 ... Outer bag 10 …… cut

──────────────────────────────────────────────────続 き Continued on front page (58) Field surveyed (Int.Cl. ⁶ , DB name) A61L 2/00-2/26

Claims (2)

(57) [Claims] 1. An inner bag in which a hydrolyzable medical material is stored in a bag using a gas-permeable and bacteria-impermeable material for at least a part of the constituent material, and the bag mouth is sealed and sealed. A step of storing the inner bag in a bag using a gas-permeable and bacteria-impermeable material for at least a part of the constituent material, and forming a sealed inner bag by sealing a bag opening; A step of storing the inner bag containing the inner bag in an outer bag made of a metal foil material coated or laminated with an adhesive resin; a step of gas sterilizing the outer bag containing the inner bag and the outer bag and drying; Removing sterilizing gas in the bag or replacing it with another gas; sealing the bag mouth of the outer bag integrally with the bag mouth of the inner bag to form a sealed triple bag; . 2. An inner bag using a gas-permeable and bacteria-impermeable material for at least a part of its constituent materials, and an inner bag containing the inner bag and made of the same material as the inner bag. The medical material is stored in an outer bag made of a metal foil material coated or laminated with a thermo-adhesive resin, and the bag mouth is heat-sealed integrally with the bag mouth of the middle bag. Packaging consisting of.