JP5206049B2 - Sterilization bag - Google Patents

Description

  The present invention relates to a sterilization bag for sterilization of articles to be sterilized for medical use, etc. using ethylene oxide or the like. Specifically, one is a synthetic resin sheet provided with an indicator ink layer, and the other is breathable. The present invention relates to a sterilization bag of a combination type in which a synthetic resin sheet and a breathable sheet are overlapped and the periphery is thermally bonded.

  Conventionally, it is necessary to use articles that have been sterilized before use, such as for medical use. For example, articles to be sterilized such as scalpels, syringes, and gauze are gas permeable so that they can be sterilized. Then, after sterilization, it is put in a sterilization bag that cannot permeate bacteria so that secondary contamination can be prevented, sealed, and then sterilized in advance using high-temperature steam, ethylene oxide gas (EOG), etc. Yes. The articles and the like after sterilization are stored in a sterilization bag until they are used for medical treatment, and are opened and used for the first time when used for medical treatment. Such sterilization bags are generally roughly classified into a combination of a sterilized paper alone and a combination of a breathable sheet such as sterilized paper and a synthetic resin sheet. The combination type of breathable sheet and synthetic resin sheet is convenient because the type and size of the stored medical device can be easily seen by making the synthetic resin sheet transparent. Combination type sterilization bags are increasing (for example, see Patent Document 1).

  Furthermore, an indicator is printed with an indicator ink or the like that changes color when sterilized on sterilized paper so that it can be visually confirmed whether the articles stored in the sterilization bag are sterilized or not. However, in the medical field, the necessary articles stored in the sterilization bag are first checked from the synthetic resin sheet side, and then the sterilization bag is turned over and printed on sterilized paper to confirm that it has been sterilized. There is a drawback that it is necessary to check the indicator, which is very troublesome. From a busy medical field, it is desired to develop a sterilization bag in which the type and size of the stored articles and the articles can be visually recognized at a glance.

On the other hand, biodegradable resins that are decomposed by microorganisms and the like are attracting attention as social demands for environmental protection increase. Specific examples of the biodegradable resin include microbial products, aliphatic polyesters such as polybutylene succinate, polycaprolactone, and polylactic acid. Furthermore, in recent years, among biodegradable resins, materials that make effective use of biomass as environmentally friendly materials have not only reduced dependence on fossil resources such as petroleum, but have also improved the environmental problems facing modern society. It is attracting attention from the viewpoint that it can contribute to the formation of a recycling-oriented society. One example is polylactic acid. Since the polylactic acid-based resin is biodegradable, it naturally undergoes hydrolysis in soil and water, and becomes a harmless decomposition product by microorganisms. Even if incinerated, the incinerator will not be damaged because the amount of combustion heat is small. In addition, since the starting material is derived from plants, it has features such as being able to escape from depleted fossil resources such as petroleum, and plastic molded products using polylactic acid, such as films, sheets, packaging bags and bottles, etc. Research has been conducted on the production of such containers and the like, and a fusing seal bag that has already been made with a fusing seal using a polylactic acid resin film has been disclosed (for example, see Patent Document 2). With such an increase in social awareness of the environment, medical-related users have been demanding sterilization bags in consideration of environmental problems.
Japanese Utility Model Publication No. 64-2766 JP 2003-291984 A

  As a result of diligent research, the present inventor has paid attention to the fact that a biodegradable resin mainly composed of an aliphatic polyester resin has a property of allowing ethylene oxide gas to permeate, thereby completing the present invention. That is, the present invention provides a sterilization bag in which the type and size of stored articles and the articles can be visually recognized at a glance, and environmental issues are taken into consideration.

In order to achieve the above object, the present invention according to claim 1 is a synthetic resin sheet having transparency , one of which is formed by laminating a base material layer and a thermoadhesive resin layer, and the other is In the sterilization bag, which is a gas-permeable breathable sheet, wherein the heat-adhesive resin layer surface of the synthetic resin sheet is overlaid on the breathable sheet, and the periphery is thermally bonded to form a peripheral heat-bonded portion. An indicator ink layer is formed between a base material layer and a heat-adhesive resin layer of the synthetic resin sheet, and the heat-adhesive resin layer is made of a biodegradable resin mainly composed of an aliphatic polyester resin. This is a sterilization bag.

  According to a second aspect of the present invention, in the sterilization bag according to the first aspect, the base material layer is composed of a polylactic acid resin film that is biaxially stretched.

  According to a third aspect of the present invention, in the sterilization bag according to the first or second aspect, the breathable sheet is made of sterilized paper.

  According to a fourth aspect of the present invention, in the sterilization bag according to the first or second aspect, the breathable sheet is made of a biodegradable resin mainly composed of an aliphatic polyester resin. It is.

In the first aspect of the present invention, one is a synthetic resin sheet having transparency formed by laminating a base material layer and a heat-adhesive resin layer, and the other is a gas-permeable breathable sheet. A combination type in which the surface of the heat-adhesive resin layer of the sheet is superimposed on the breathable sheet, the periphery is thermally bonded, and the indicator ink layer is formed between the base material layer and the heat-adhesive resin layer of the synthetic resin sheet By using the sterilization bag, the type and size of the medical device stored from the synthetic resin sheet side can be easily seen, and at the same time the indicator ink layer can be seen, so that the stored medical device and other articles can be sterilized. You can see at a glance that it is done. In addition, by using a biodegradable resin whose main component is an aliphatic polyester resin for the heat-adhesive resin layer, the sterilization gas can permeate the breathable sheet and the heat-adhesive resin layer to discolor the indicator ink layer. Can do. Furthermore, since the indicator ink layer is formed between the base material layer and the heat-adhesive resin layer, the indicator ink layer is protected and does not come off even when rubbed with an external force, and directly contacts the contained articles. Therefore, there is an effect that ink adhesion to articles can be prevented.

  The present invention according to claim 2 can be a sterilization bag in consideration of environmental problems by adopting a structure comprising a polylactic acid resin film in which the base material layer is biaxially stretched.

  According to the third aspect of the present invention, the use of sterilized paper for the air permeable sheet improves the gas permeable property of gas such as EOG and improves the gas sterilization suitability.

  The present invention according to claim 4 can be a sterilization bag in consideration of environmental problems by using a biodegradable resin mainly composed of an aliphatic polyester resin for the breathable sheet.

The above-described present invention will be described in detail below with reference to the drawings.
1 is a plan view showing a first embodiment of a sterilization bag according to the present invention, FIG. 2 is a sectional view taken along line XX in FIG. 1, and FIG. 3 shows a second embodiment of the sterilization bag according to the present invention. 4 is a cross-sectional view taken along line YY in FIG. 3. Reference numerals 1 and 101 are synthetic resin sheets, 2 and 102 are breathable sheets, 3 is a non-thermally bonded portion, and 4a and 4b are peripheral edges. Thermal bonding portion, 4c is a chevron-shaped peripheral thermal bonding portion, 5 is an accommodating portion, 6 is an opening portion, 7 is an indicator ink layer, 8 is an opening mark, 11 and 111 are base material layers, and 12 and 112 are thermal adhesive resins Layers 13, 113, and 123 are adhesive layers, 104a, 104b, and 104c are peripheral thermal adhesive portions, 109 is a notch, 121 is a biaxially stretched polylactic acid resin film, 122 is a biodegradable resin, and A and A ′ are Each sterilization bag is shown.

  The first embodiment of the present invention is as shown in FIGS. As shown in FIGS. 1 and 2, the sterilization bag A according to the present invention is a synthetic resin sheet 1 in which one of a rectangular shape is a laminate of a base material layer and a heat-adhesive resin layer, and the other is gas-permeable. The breathable sheet 2, the heat-adhesive resin layer surface of the synthetic resin sheet 1 is overlapped with the breathable sheet 2, and both opposite ends (left and right ends in FIG. 1) are thermally bonded to each other, and the peripheral heat-bonding portion 4 a 4b is formed, and the non-thermally bonded portion 3 is formed along the upper side, and the peripheral thermal bonded portions 4a and 4b are connected to each other so as to protrude outwardly with the storage portion 5 and the nonthermally bonded portion 3 being separated. The peripheral heat bonding part 4 c is formed and the lower side is the opening 6. An indicator ink layer 7 that is discolored by sterilizing ethylene oxide gas (hereinafter referred to as EOG) is provided on the side of the housing portion 5 of the synthetic resin sheet 1, and an opening mark indicating an opening at the center upper portion of the non-thermal bonding portion 3 8 is printed.

  FIG. 2 is a cross-sectional view taken along the line XX of FIG. 1 and is a cross-sectional view illustrating a laminated configuration of the sterilization bag A showing the first embodiment of the present invention and explaining the main part. As shown in FIG. 2, the synthetic resin sheet 1 is formed by laminating a base material layer 11 and a heat-adhesive resin layer 12 via an adhesive layer 13, and the surface of the heat-adhesive resin layer 12 is superimposed on the breathable sheet 2. Yes. An indicator ink layer 7 is formed on the surface of the base material layer 11 that is laminated with the heat-adhesive resin layer 12.

  Further, the peripheral thermal adhesive portions 4a and 4b and the chevron peripheral thermal adhesive portion 4c of the sterilization bag A are thermally bonded so as to be peelable between the synthetic resin sheet 1 and the breathable sheet 2 from the opening mark 8, in particular. The chevron-shaped peripheral heat-bonding portion 4c can be easily opened by forming a chevron projecting outward. The sterilization bag A can be easily opened by using a line seal with a narrow bonding width of the heat-bonding portion so that it is easier, or at least on the portion of the breathable sheet 2 that is heat-bonded to the heat-adhesive resin layer 12. A peelable heat sealant may be coated. Further, when tearing and opening without peeling, it is not necessary to provide the non-thermally bonded portion 3 and the chevron-shaped peripheral thermal adhesive portion 4c, and it is only necessary to provide a peripheral thermal adhesive portion on the upper edge.

  The synthetic resin sheet 1 only needs to be transparent so that the articles to be accommodated can be visually recognized, and can be colored. The base material layer 11 only needs to have heat resistance that can withstand thermal bonding and EOG resistance that can withstand EOG sterilization, and a biaxially stretched film using a resin such as polyethylene terephthalate, nylon, polypropylene, polyethylene, or polylactic acid is used. It is done. As the heat-adhesive resin layer 12, a material that is thermally bonded to the air-permeable sheet 2 and has an appropriate adhesive strength and that appropriately transmits EOG can be used. Polylactic acid-based, polybutylene succinate-based, butylene succinate / Adipate copolymer system, butylene succinate / carbonate copolymer, polycaprolactone-based aliphatic polyester-based biodegradable resin can be used. The base material layer 11 and the heat-adhesive resin layer 12 are laminated by a known method such as a dry lamination method or an extrusion lamination method.

  The gas-permeable sheet 2 is used in gas sterilization such as EOG 1) The property of easily permeating EOG and the like but not permeating bacteria 2) Heat resistance to withstand sterilization temperature 3) Preferably heat bonding of the synthetic resin sheet 1 A material having properties such as being capable of being thermally bonded to the conductive resin layer 12, and a biodegradable resin mainly composed of sterilized paper, non-woven fabric, aliphatic polyester resin, and a plurality of through holes. A laminated material of an axially stretched polylactic acid resin film and a biodegradable resin mainly composed of an aliphatic polyester resin can be used. Moreover, it is good also as what coat | covered the heat sealing agent which improves an easy peeling function on the surface heat-bonded with the synthetic resin sheet 1 of these base materials entirely or partially.

  As shown in FIG. 1, the indicator ink layer 7 for EOG sterilization is printed on the inner surface of the base material layer so that the color changes by sterilization and the sterilized can be visually recognized. It can be confirmed at the same time, and at the same time, the articles of the sterilized medical device can be visually recognized, and this is a preferable mode for use in a busy medical field. The indicator ink layer 7 can be formed on the base material layer 11 by performing gravure printing using a commercially available indicator ink for EOG. The indicator ink includes indicator ink containing a basic substance hydrochloride and a PH indicator by utilizing the property that ethylene oxide binds to hydrogen chloride, and an azo dye having a specific molecular structure, for example. Indicator inks that use the principle of color change by reaction with ethylene oxide. Specifically, “Gratone GSN Red EO-32” manufactured by Sakata Inx Co., Ltd. “EO-13” manufactured by Sakura Crepas Co., Ltd. Is mentioned.

  Next, a method of using the sterilization bag A shown in FIG. 1 will be described. When using the sterilization bag A, the medical device to be sterilized is stored in the storage unit 5 through the opening 6, and the periphery of the opening 6 is thermally bonded and sealed, and then the predetermined temperature, time, pressure, and humidity are set. EOG sterilization is performed under sterilization conditions to sterilize medical instruments. In performing medical treatment such as treatment and surgery, it is confirmed that the indicator ink layer 7 formed on the base material layer 11 from the synthetic resin sheet 1 side of the sterilization bag A changes color to indicate sterilization. After confirming the type and size of the medical devices stored in the storage unit 5, the synthetic resin sheet 1 and the non-thermally bonded part 3 of the breathable sheet 2 are respectively picked from the opening mark 8 and pulled in opposite directions. Thus, the chevron-shaped peripheral heat bonding portion 4c and the peripheral heat bonding portions 4a, 4b can be peeled from each other and opened, and the contents can be easily taken out. In the case where the non-thermal bonding portion 3 and the chevron-shaped peripheral thermal bonding portion 4c are not provided and the peripheral thermal bonding portion is provided on the upper edge, if the tear opening is performed without peeling from the predetermined position provided with the opening means, Good.

  The second embodiment of the present invention is as shown in FIGS. As shown in FIGS. 3 and 4, the sterilization bag A ′ according to the present invention is mainly composed of a base material layer 111 made of a biaxially stretched polylactic acid resin film and an aliphatic polyester resin. A heat-adhesive resin layer 112 made of a biodegradable resin is a synthetic resin sheet 101 laminated via an adhesive layer 113, and the other is a biaxially stretched polylactic acid resin film 121 provided with a plurality of through holes; A gas-permeable breathable sheet 102 in which a biodegradable resin 122 mainly composed of an aliphatic polyester-based resin is laminated via an adhesive layer 123, and the surface of the heat-adhesive resin layer 112 of the synthetic resin sheet 101 Is superimposed on the surface of the biodegradable resin 122 of the breathable sheet 102, and the peripheral edges of the three sides are thermally bonded to form the peripheral thermal adhesive portions 104a, 104b, and 104c, and the lower side is the opening 6. An indicator ink layer 7 that changes color by performing EOG sterilization is provided on the side of the accommodation portion 5 of the synthetic resin sheet 101, and a notch 109 is provided in the vicinity of the peripheral thermal adhesive portion 104c at the end of the peripheral thermal adhesive portion 104b. Yes.

  FIG. 4 is a cross-sectional view taken along line YY of FIG. 3 and shows a stacked structure of a sterilization bag A ′ showing a second embodiment of the present invention. As shown in FIG. 4, the indicator ink layer 7 is formed on the surface of the base material layer 111 that is laminated with the heat-adhesive resin layer 112. With such a configuration, in the sterilization bag A ′ according to the second embodiment, the synthetic resin sheet 101 and the breathable sheet 102 are both made of a biodegradable resin and have excellent discardability. In addition, the ratio of the polylactic acid-based resin in the sterilization bag A 'can be increased, and the environment is considered.

Next, the present invention will be described in more detail with reference to the following examples.
Using a biaxially stretched polyethylene terephthalate film (PET) with a single-sided corona treatment having a thickness of 12 μm, the product name of Sakata Inx Co., Ltd. is used as an indicator ink by gravure printing on the corona-treated surface; Gratone GSN red EO-32 The indicator ink layer was printed and formed at a predetermined position, and a predetermined pattern was printed with a gravure ink using a urethane resin as a binder. On the other hand, as a biodegradable resin comprising polybutylene succinate, a product name manufactured by Mitsubishi Chemical Co., Ltd .; using GS-Pla, a hot melt extrusion film was formed by a T-die extruder, and a single-sided corona treatment with a thickness of 50 μm was performed. A polybutylene succinate film (PBS) for the applied heat-adhesive resin layer was prepared. Thereafter, a polyester polyol-isocyanate-based two-component adhesive is applied to the printing surface, and the corona-treated surface of the polybutylene succinate film is bonded by a dry lamination method (DL) to form a PET / printing, indicator ink layer A synthetic resin sheet having a structure of / DL / PBS was prepared. Using an ordinary bag making machine having two feeding axes using 70 g / m ² of sterilized paper (manufactured by Mishima Paper Co., Ltd., trade name: Himic) for the breathable sheet, the synthetic resin sheet produced above and the ventilation A flexible sheet is attached to each paper feed shaft, and the PBS side of the synthetic resin sheet is overlapped with the breathable sheet to form a combination bag, which can be peeled off by the peripheral heat bonding parts 4a and 4b and the chevron peripheral heat bonding part 4c. A sterilization bag A according to the first embodiment shown in FIG.

  Replace the PET of the base material layer of the synthetic resin sheet of Example 1 with a biaxially stretched polylactic acid resin film (OPLA) having a single-sided corona treatment with a thickness of 25 μm, print on the corona-treated surface, OPLA / printing, indicator A synthetic resin sheet having a configuration of ink layer / DL / PBS was prepared. Other than that, a sterilization bag was produced by the same bag making method using the same breathable sheet as in Example 1. Note that Terramac TF manufactured by Unitika Ltd. was used for the biaxially stretched polylactic acid resin film.

  As a biodegradable resin composed of polybutylene succinate, a product name manufactured by Mitsubishi Chemical Corp .; using GS-Pla, formed by hot melt extrusion with a T-die extruder, a polybutylene succinate film having a thickness of 50 μm ( PBS) was produced to make a breathable sheet. Using this breathable sheet and the synthetic resin sheet produced in Example 2, each of the synthetic resin sheet produced above and the breathable sheet was wound using a normal bag making machine having two feeding axes. 3, the PBS surface of the synthetic resin sheet is overlapped with the air-permeable sheet, and the bag is made of a combination, thermally bonded by the peripheral heat bonding portions 104 a, 104 b, and 104 c, and having an opening 6. A sterilization bag was prepared.

  A gauze was enclosed in the storage part of the sterilization bag prepared in Examples 1 to 3, and the opening was thermally bonded and sealed to prepare a test sample. Then, for each test sample, using an EOG sterilizer, a mixed gas of EOG: carbon dioxide gas = 20: 80 (volume ratio), a sterilization temperature of 55 ° C., a relative humidity of 50% RH, and a sterilization time of 4 hours After the EOG sterilization treatment, each sample sample was observed. In each of Examples 1 to 4, the indicator ink layer was discolored, and it was confirmed that sterilization was performed, and the contents of the gauze were clear. I was able to confirm.

It is a top view which shows 1st embodiment of the bag for sterilization concerning this invention. It is the XX sectional view taken on the line in FIG. It is a top view which shows 2nd embodiment of the bag for sterilization concerning this invention. It is the YY sectional view taken on the line in FIG.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1,101 Synthetic resin sheet 2,102 Breathable sheet 3 Non-thermal-bonding part 4a, 4b Peripheral heat-bonding part 4c Mountain-shaped peripheral heat-bonding part 5 Storage part 6 Opening part 7 Indicator ink layer 8 Opening mark 11, 111 Base material layer 12, 112 Thermal adhesive resin layer 13, 113, 123 Adhesive layer 104a, 104b, 104c Peripheral thermal adhesive part 109 Notch 121 Biaxially stretched polylactic acid resin film 122 Biodegradable resin A, A 'Sterilization bag

Claims (4)

One is a synthetic resin sheet having transparency formed by laminating a base material layer and a heat-adhesive resin layer, and the other is a gas-permeable breathable sheet, and the surface of the heat-adhesive resin layer of the synthetic resin sheet is In the sterilization bag formed by overlapping the breathable sheet and thermally bonding the periphery to form a peripheral heat bonded portion, an indicator ink layer is provided between the base material layer and the heat adhesive resin layer of the synthetic resin sheet. A sterilization bag, wherein the heat-adhesive resin layer is formed of a biodegradable resin mainly composed of an aliphatic polyester resin. The sterilization bag according to claim 1, wherein the base material layer is made of a polylactic acid resin film biaxially stretched. The sterilization bag according to claim 1, wherein the breathable sheet is made of sterilized paper. The sterilization bag according to claim 1, wherein the breathable sheet is made of a biodegradable resin mainly composed of an aliphatic polyester resin.

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