Medical device package and medical device packaging bag

Abstract

To provide a gas-sterilized medical device package by which a housed medical device can be visually recognized, and which has excellent flow of sterilization gas into a sterilization bag.SOLUTION: A medical device package 1 comprises: a medical device 6; and a medical device packaging bag 2 that houses the medical device 6 and is sealed. The medical device packaging bag 2 comprises a sterilization gas permeable bottom face sheet 3 and a transparent top face sheet 4 laminated on the top part of the sterilization gas permeable bottom face sheet 3. The sterilization gas permeable bottom face sheet 3 comprises a bottom surface part 31 and side parts which face each other and extend above the bottom surface part 31, and at least one side part is equipped with internally protruded parts 33, 34 having sterilization gas permeability which extend in a longitudinal direction of the side part, and protrude in an inner side direction of the medical device package 1, and the transparent top face sheet 4 and the sterilization gas permeable bottom face sheet 3 are sealed by a heat seal part 7 formed on a peripheral part or the whole circumference near the peripheral part.SELECTED DRAWING: Figure 5

Description

[Technical Field]

[0001] The present invention relates to a medical device package that contains medical devices and is gas-sterilized, and a medical device packaging bag that contains medical devices and is used for gas-sterilization. [Background technology]

[0002] Conventionally, sterilization treatment using a sterilizing gas (e.g., ethylene oxide gas) has been carried out during the production of medical device packages in which medical devices are placed in packaging bags and sterilized. Sterilization treatment using a sterilizing gas does not require treatment under high pressure and high temperature, and is therefore used to sterilize medical devices such as plastics that do not require heat treatment. Sterilization gas (ethylene oxide gas) is a substance harmful to the human body, and ethylene oxide may remain in medical device packages immediately after sterilization. Therefore, a process (called aeration) is carried out after sterilization to remove the sterilization gas (ethylene oxide gas) from the medical device packages. In aeration, for example, medical devices are placed in a sterilizer such as a gas aerator and exposed to air for a predetermined period of time, e.g., 12 to 72 hours, to eliminate or reduce the ethylene oxide. After this aeration, or instead of aeration, the medical devices are stored in a warehouse or the like for a predetermined period of time after sterilization with ethylene oxide gas, thereby eliminating or reducing the ethylene oxide. In this way, the medical device package in which residual ethylene oxide has been eliminated or reduced and the sterility is maintained is provided to the medical site. Packaging bags that can be sterilized with a sterilizing gas as described above have been proposed, for example, in Japanese Patent Laid-Open No. 2015-195963 (Patent Document 1) and Utility Model Registration No. 3195730 (Patent Document 2). The sterilization bag 1 in Patent Document 1 is composed of a top sheet 2 having a non-breathable sheet 4 and breathable sterilized paper 5, and a back sheet 3 also made of the non-breathable sheet 4. It has a folded portion 10 that is formed by folding the non-breathable sheet 4 along at least one side of the periphery and continues from the top sheet 2 to the back sheet 3, an openable portion 14 that is formed on the top sheet 2 and is opened when the contents X are removed, and an openable seal portion 16 where the non-breathable sheet 4 or the sterilized paper 5 that form both side edges of the openable portion 14 are heat-sealed so that they can be peeled away from each other, and the folded portion 10 has a valley fold 12 that is folded towards the inside of the sterilization bag 1 so that the outer surface of the non-breathable sheet 4 faces each other. The sterilization bag 1 of Patent Document 2 comprises a substantially rectangular first film portion 2, a second film portion 3 overlapping the first film portion 2 on one side in a first direction along a first edge of the first film portion 2, a nonwoven fabric 4 overlapping the first film portion 2 on the other side in the first direction of the first film, an opening 7 opened at part of the side edges of the first film portion 2 and the second film portion 3, a gusset portion 5A provided on the side edge opposite the opening 7 and having a fold line on the inside, and wing portions formed by peelably sealing the side edges of the second film portion 3 and the nonwoven fabric 4, wherein the length of the gusset portion 5A in the second direction is different from the length of the wing portions in the second direction which is substantially perpendicular to the first direction. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Japanese Patent Application Laid-Open No. 2015-195963 [Patent Document 2] Utility Model Registration No. 3195730 Summary of the Invention [Problem to be solved by the invention]

[0004] In the sterilization bag 1 of Patent Document 1, the only area into which the sterilization gas flows is the sterilization paper 5, which is in the shape of a narrow strip, and therefore the flow of the sterilization gas into the sterilization bag is not good, and there is also the possibility that the sterilization gas is not discharged well during aeration. Furthermore, in the sterilization bag 1 of Patent Document 2, the entire underside of the sterilization bag 1 is formed from nonwoven fabric 4, which may allow sterilization gas to flow into the sterilization bag and allow sterilization gas to be discharged during aeration more smoothly than the sterilization bag of Patent Document 1. However, in the sterilization bag 1 of Patent Document 2, the underside of the sterilization bag 1 that comes into contact with the placement surface when placed is the inlet for sterilization gas, so if the sterilization gas does not flow smoothly into the sterilization bag, or if the sterilization gas is not discharged smoothly during aeration, it may not be possible. It is also preferable to check the medical equipment stored in the gas-sterilized medical equipment package before use. Therefore, an object of the present invention is to provide a gas-sterilized medical device package that allows the stored medical devices to be visually confirmed, and that allows for good flow of sterilization gas into the sterilization bag, good discharge of sterilization gas when aeration is performed, and good gas circulation inside and outside the sterilization bag during storage before shipment, as well as a medical device packaging bag for gas sterilization that can be used for the medical device package. [Means for solving the problem]

[0005] The above objectives are achieved by the following: (1) A medical device package comprising a medical device and a sealed medical device packaging bag containing the medical device, and which has been gas sterilized, The medical device packaging bag comprises a sterilization gas-permeable lower sheet and a transparent upper sheet laminated on top of the sterilization gas-permeable lower sheet, The sterilization gas-permeable lower sheet has a bottom surface and opposing side surfaces extending upward from the bottom surface, at least one of the side surfaces having a sterilization gas-permeable inward protrusion extending in the longitudinal direction of the side surface and protruding toward the inside of the medical device package, and the transparent upper sheet and the sterilization gas-permeable lower sheet are sealed with a heat seal formed around the entire periphery or near the periphery.

[0006] (2) A medical device package according to (1) above, wherein each of the opposing side portions has a sterilization gas permeable inward protrusion extending in the longitudinal direction of the side portion and protruding inward of the medical device package. (3) The medical device package according to (1) or (2) above, wherein the inward protrusion has a valley extending longitudinally through the center of the side portion. (4) A medical device package according to any one of (1) to (3) above, wherein one end and the other end in the longitudinal direction of the medical device package are heat-sealed at all of the ends of the side portions including the inward protrusion. (5) A medical device package according to any one of (1) to (3) above, wherein one and the other longitudinal ends of the medical device package are heat-sealed at all of the side edges, including the inward protrusion, and the apex of the valley of the inward protrusion within the storage compartment is fused to the end of the fused part between the transparent upper sheet and the bottom surface of the sterilization gas-permeable lower sheet. (6) The medical device package according to any one of (1) to (5) above, wherein the medical device is a catheter. (7) The medical device package according to (6) above, wherein the catheter is placed on the upper surface of the sheet and is held by the sheet.

[0007] The above objectives are also achieved by the following: (8) A medical device packaging bag having a storage section for medical devices and to be gas sterilized after sealing, the medical device packaging bag comprising a sterile gas-permeable lower sheet and a transparent upper sheet laminated on and fused to the upper part of the sterile gas-permeable lower sheet; The sterilization gas-permeable lower sheet has a bottom surface and opposing side surfaces extending upward from the bottom surface, and at least one of the side surfaces has a sterilization gas-permeable inward protrusion extending in the longitudinal direction of the side surface and protruding inward of the packaging bag. (9) A medical device packaging bag as described in (8) above, wherein each of the opposing side portions has a sterilization gas permeable inward protrusion extending in the longitudinal direction of the side portion and protruding inward of the packaging bag. (10) The medical device packaging bag according to (8) or (9), wherein the inward protrusion has a valley extending longitudinally through the center of the side portion. [Effects of the Invention]

[0008] The medical device package of the present invention comprises a medical device and a sealed medical device packaging bag containing the medical device. The medical device packaging bag comprises a sterile gas-permeable bottom sheet and a transparent top sheet laminated on top of the sterile gas-permeable bottom sheet. The sterile gas-permeable bottom sheet has a bottom and opposing side portions extending upward from the bottom, and at least one of the side portions has a sterile gas-permeable inward protrusion extending in the longitudinal direction of the side portions and protruding toward the inside of the medical device package. The transparent top sheet and the sterile gas-permeable bottom sheet are sealed with a heat seal formed around the entire periphery or near the periphery. The medical device packaging bag of the present invention has a storage area for medical devices and is gas sterilized after sealing. The medical device packaging bag comprises a sterile gas-permeable lower sheet and a transparent upper sheet laminated on top of and fused to the sterile gas-permeable lower sheet. The sterile gas-permeable lower sheet has a bottom surface and opposing side surfaces extending upward from the bottom surface, and at least one of the side surfaces has a sterile gas-permeable inward protrusion extending in the longitudinal direction of the side surface and protruding toward the inside of the medical device package. In this medical device package and medical device packaging bag, the sterile gas-permeable lower sheet has not only a bottom surface that forms the underside of the medical device packaging bag, but also opposing side surfaces that extend upward from the bottom surface, and at least one of the side surfaces has a sterile gas-permeable inward protrusion that extends in the longitudinal direction of the side surface and protrudes toward the inside of the medical device package. Therefore, the sterilization gas-permeable lower sheet has a sufficient area, sides that do not come into contact with the placement surface when placed, and inward protrusions, which allow the sterilization gas to flow into the sterilization bag, i.e., the sterilization of the stored medical devices, and also allows for good discharge of the sterilization gas when aeration is performed and good gas circulation inside and outside the sterilization bag during storage before shipment, with little residual sterilization gas. Furthermore, the top surface of the medical device packaging bag is made of a transparent top sheet, so the stored medical devices can be easily seen. [Brief explanation of the drawings]

[0009] [Figure 1] FIG. 1 is a front view of a medical device package according to an embodiment of the present invention. [Figure 2] FIG. 2 is a rear view of the medical device package shown in FIG. [Figure 3] FIG. 3 is an enlarged plan view of the medical device package shown in FIG. 1 rotated 180 degrees. [Figure 4] FIG. 4 is an enlarged cross-sectional view taken along line AA in FIG. [Figure 5] FIG. 5 is an enlarged cross-sectional view taken along line BB in FIG. [Figure 6] FIG. 6 is an enlarged cross-sectional view of the portion taken along line DD in FIG. 2, with the portion omitted. [Figure 7] FIG. 7 is an enlarged cross-sectional view of a medical device package according to another embodiment of the present invention. [Figure 8] FIG. 8 is a front view of a medical device package according to another embodiment of the present invention. [Figure 9] FIG. 9 is a rear view of the medical device package shown in FIG. [Figure 10] FIG. 10 is an enlarged cross-sectional view taken along line EE in FIG. [Figure 11] FIG. 11 is an enlarged cross-sectional view of a medical device package according to another embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0010] The medical device package and the medical device packaging bag of the present invention will be described with reference to the illustrated embodiments. The medical device package 1 of the present invention comprises a medical device (in other words, a medical storage item) 6 and a medical device packaging bag 2 that contains the medical device 6 and is sealed, and is gas-sterilized.

[0011] The medical device packaging bag 2 comprises a sterile gas-permeable bottom sheet 3 and a transparent top sheet 4 laminated on top of the sterile gas-permeable bottom sheet 3. The sterile gas-permeable bottom sheet 3 comprises a bottom portion 31 and opposing side portions extending upward from the bottom portion 31, at least one of the side portions having sterile gas-permeable inward protrusions 33, 34 extending in the longitudinal direction of the side portions and protruding toward the inside of the medical device package 1, and the transparent top sheet 4 and the sterile gas-permeable bottom sheet 3 are sealed together by a heat-sealed portion 7 formed around the entire periphery at or near the periphery.

[0012] 1 to 6, the medical device packaging bag 2 of the present invention comprises a sterilization gas-permeable lower sheet 3 and a transparent upper sheet 4 laminated on top of the sterilization gas-permeable lower sheet 3. The sterilization gas-permeable lower sheet 3 comprises a bottom surface 31 and opposing side surfaces extending upward from the bottom surface 31, and at least one of the side surfaces has sterilization gas-permeable inward protrusions 33, 34 extending in the longitudinal direction of the side surfaces and protruding inward of the medical device package 1.

[0013] 1 to 6, the medical device package 1 of the illustrated embodiment comprises a medical device 6 and a medical device packaging bag 2 that contains the medical device 6 and is sealed. In the sealed state, the medical device package 1 is sterilized with gas. Ethylene oxide gas is preferred as the sterilizing gas, but hydrogen peroxide gas, formalin, etc. may also be used.

[0014] In the medical device package 1 of this embodiment, the medical device 6 is placed on a sheet 5 and partially held by the sheet 5 when contained in the packaging bag 2. The sheet 5 may be made of a backing board, cardboard, corrugated cardboard, or a resin sheet. Any medical device 6 that can be sterilized by gas sterilization may be used. In this embodiment, a catheter is used. The catheter includes a catheter tube 61 and a hub 62 fixed to the proximal end of the catheter tube 61. The hub 62 is held to the sheet 5 by a holding portion 52, and the catheter tube 61 is held to the sheet 5 at multiple locations by holding portions 53. The medical device to be contained is not limited to those held by a sheet; the medical device may be directly contained in the packaging bag 2. In particular, for angiography catheters and guiding catheters with a tip shape (not shown), it is preferable that the tip shape be made of a transparent film.

[0015] As shown in Figures 3 to 6, the medical device packaging bag 2 comprises a sterile gas-permeable bottom sheet 3 and a transparent top sheet 4 laminated on top of the sterile gas-permeable bottom sheet 3. The transparent top sheet 4 and the sterile gas-permeable bottom sheet 3 are sealed together by a heat seal 7 formed around the entire periphery or near the periphery. The medical device packaging bag 2 has a storage compartment 8 inside, in which the above-mentioned medical device 6 (and sheet 5) is stored.

[0016] The sterilization gas-permeable lower sheet 3 is permeable to sterilization gas, is impermeable to bacteria, and is flexible, and at least the portion that contacts the transparent upper sheet 4 to form the heat-sealed portion 7 has heat-sealability. The thickness of the sterilization gas-permeable lower sheet 3 is preferably 50 to 200 μm. Furthermore, since the sterilization gas-permeable lower sheet 3 is permeable to sterilization gas, it is opaque.

[0017] In this embodiment, the sterilization gas-permeable lower sheet 3 has a bottom portion 31 and opposing side portions extending upward from the bottom portion 31, and further has sterilization gas-permeable inward protrusions 33, 34 extending longitudinally from both sides and protruding toward the inside of the medical device package. The inward protrusions 33, 34 have valleys 35, 36 extending longitudinally through the center of the side portions. In this embodiment, as shown in Fig. 6, the inward protrusions 33, 34 are formed along substantially the entire length of the side portions of the medical device packaging bag 2 (the entire length excluding both end portions).

[0018] For this reason, the storage section 8 of the packaging bag 2 has both side portions recessed inward, as shown in Figure 5. Furthermore, the opposing both side portions having these inward protruding portions 33, 34 are made of the sterilization gas permeable lower sheet 4, so the packaging bag 2 has a wide sterilization gas permeable surface.

[0019] The sides of the sterile gas-permeable lower sheet 3 have ridges folded inward from both side edges of the bottom portion 31 into the packaging bag 2, valleys 35, 36 folded outward at the centers of the inward protrusions 33, 34, and edges fixed to the side edges of the transparent upper sheet 4 at fixing portions 14, 15. When pressed, the sides of the medical device package 1 are folded and their thickness is reduced, so no bulkiness is caused by the sides.

[0020] The depth of the inward protrusions 33, 34 on the sides, in other words, the distance (width) between the side edges of the bottom portion 31 and the valleys 35, 36, is preferably 10 to 30% of the total width (distance between the fixing portions 14 and 15) (for example, if the total width is 110 mm, then approximately 10 to 35 mm), and particularly preferably 15 to 25% (for example, if the total width is 110 mm, then approximately 15 to 30 mm).

[0021] Specific examples of the sterilization gas-permeable lower sheet 3 include a nonwoven fabric made of thermoplastic resin fibers, a porous sheet made of thermoplastic resin, and a paper material coated with a heat-sealable material in the area where the heat seal portion is to be formed.

[0022] The nonwoven fabric used for the sterilization gas-permeable lower sheet 3 is not particularly limited, but examples include breathable nonwoven fabric sheets made from synthetic fibers primarily composed of synthetic resin fibers such as polyolefins (e.g., polyethylene and polypropylene), polyethylene terephthalate, and polyamide, or composite fibers of natural and synthetic fibers (e.g., cellulose fibers). Examples of polyolefin nonwoven fabrics include spunbond nonwoven fabrics, meltblown nonwoven fabrics, and nonwoven fabrics made of three-dimensional network fibers fibrillated by flash spinning. Such nonwoven fabrics have a specific surface area of ​​1 m 2 / g or more, and the porosity is preferably 40 to 75%. The basis weight of the nonwoven fabric is preferably 20 to 200 g / m 2 Specifically, Tyvek (trademark) manufactured by DuPont Co., Ltd., which is a nonwoven fabric made of polyethylene fibers, can be suitably used.

[0023] The sheet used for the transparent upper sheet 4 must be transparent enough to allow the stored medical devices to be seen, flexible, and have heat sealing properties at least in the area that contacts the sterilization gas-permeable lower sheet 3 to form the heat-sealed portion 7.

[0024] Examples of the transparent upper sheet 4 include sheets made of thermoplastic resins such as polyethylene, polypropylene, polybutene, polybutadiene, ethylene-vinyl acetate copolymer (EVA), polyolefins such as ethylene-α-olefin copolymers, polyamide, polyurethane, polyether, polyester, and vinyl chloride; and sheets formed from various thermoplastic elastomers such as olefin-based thermoplastic elastomers, styrene-based thermoplastic elastomers, ester-based thermoplastic elastomers, amide-based thermoplastic elastomers, and vinyl chloride-based thermoplastic elastomers.

[0025] Furthermore, the transparent upper sheet 4 can also be made of a stretched polyolefin film such as polypropylene or polyethylene, a biaxially stretched polyamide film such as nylon 6 or nylon 66, or a biaxially stretched polyester resin film such as polyethylene terephthalate or polybutylene terephthalate.

[0026] The sheet used for the transparent top sheet 4 may also be a laminated sheet having a base layer and an adhesive layer. The base layer is the same as the sheet used for the transparent top sheet 4 described above. The adhesive layer may be made of low-density polyethylene (LDPE), linear low-density polyethylene (L-LDPE), ethylene-α-olefin copolymer, ethylene-vinyl acetate copolymer, ethylene-acrylic acid copolymer, ethylene-acrylic acid ester copolymer, polypropylene, or copolymers thereof. The adhesive layer may be provided on the underside of the transparent top sheet 4 in a region that contacts the sterilization gas-permeable bottom sheet 3 in the heat-sealed portion 7, or may be provided on the entire underside of the transparent top sheet 4. The thickness of the transparent upper sheet 4 is preferably 50 to 200 μm.

[0027] In the medical device packaging bag 2, the transparent top sheet 4 and the sterilization gas-permeable bottom sheet 3 are sealed at a heat-sealed section 7 formed around the entire periphery or near the periphery. The medical device packaging bag 2 has an internal storage section 8 in which the above-mentioned medical device 6 (and sheet 5) is stored. The heat-sealed section 7 is formed by welding, specifically by heat welding, high-frequency welding, ultrasonic welding, etc. In the medical device package 1 of this embodiment, the heat-sealed portion 7 is formed in a ring shape that surrounds the storage portion 8 of the packaging bag 2.

[0028] The heat-sealed section 7 has one side end fastening section 14 and the other side end fastening section 15 extending in the longitudinal direction of both sides (both sides in Figs. 1 and 2) of the medical device package 1. The one side end fastening section 14 and the other side end fastening section 15 extend from one end or its vicinity to the other end of the medical device package 1. At the one side end fastening section 14 and the other side end fastening section 15, both side ends of the transparent upper sheet 4 and the upper ends of both sides of the sterilization gas-permeable lower sheet 3 are fastened, as shown in Fig. 5.

[0029] The heat-sealed portion 7 includes a one-end seal portion 7a formed at one end (the upper end in Figs. 1 and 2) of the medical device package 1. As shown in Figs. 1 and 2, the one-end seal portion 7a includes a one-side fastening portion 12, an other-side fastening portion 13, and a central fastening portion 11 formed to connect the one-side fastening portion 12 and the other-side fastening portion 13.

[0030] Similarly, the heat-sealed portion 7 includes an other-end seal portion 7b formed at the other end (the lower end in Figs. 1 and 2) of the medical device package 1. As shown in Figs. 1 and 2, the other-end seal portion 7b includes one-side fastening portion 17, the other-side fastening portion 18, and a central fastening portion 16 formed to connect the one-side fastening portion 17 and the other-side fastening portion 18.

[0031] The one-side fixing portions 12, 17 and the other-side fixing portions 13, 18 are folded back at the valleys 35, 36, and the ends of the inward protruding portions (side portions) 33, 34 in the folded state are fixed to the ends of the top sheet 4. In particular, in this embodiment, as shown in Fig. 4, the opposing portions of the inward protrusions 33, 34 in the folded state are also fixed at the one side fixing portion 12 (17) and the other side fixing portion 13 (18). Furthermore, in this embodiment, as shown in Fig. 4, the opposing portions of the inward protrusions 33, 34 and the bottom portion 31 are also fixed at the one side fixing portion 12 (17) and the other side fixing portion 13 (18). And, in this embodiment, as shown in Fig. 4, the top sheet 4, the inward protrusions 33, 34 of the sterile gas-permeable bottom sheet 3, and the bottom portion 31 are fixed and integrated at the one side fixing portion 12 (17) and the other side fixing portion 13 (18).

[0032] Therefore, in this embodiment, at one and the other longitudinal ends of the medical device package 1, all of the side edges, including the inward protrusions 33, 34, are heat-sealed. Furthermore, the apexes of the valleys 35, 36 of the inward protrusions 33, 34 within the storage compartment 8 are fused to the ends 22, 23, 24, 25 of the fused portion between the transparent top sheet 4 and the bottom surface 31 of the sterilization gas-permeable bottom sheet 3. In other words, near the apexes of the valleys 35, 36 of the inward protrusions 33, 34, fused edges 22, 23, 24, 25 are provided where the transparent top sheet 4 and the bottom surface 31 of the sterilization gas-permeable bottom sheet 3 are directly fused, and further, these fused edges 22, 23, 24, 25 are also airtightly fused to the apexes of the valleys 35, 36 of the inward protrusions 33, 34. Therefore, the areas near the apexes of the valleys 35, 36 of the inward protruding portions 33, 34 (the inner end portions where the folded sheets overlap) are well sealed in an airtight state.

[0033] Furthermore, at the one side fastening portion 12 (17) and the other side fastening portion 13 (18), the one side end fastening portion 14 and the other side end fastening portion 15 are also integrated. At the central seal portions 11, 16 in the one end seal portion 7a and the other end seal portion 7b, the transparent top sheet 4 and the bottom surface portion 31 of the sterilization gas permeable bottom sheet 3 are directly fused together.

[0034] In the medical device package 1 of this embodiment, between the inside of one end seal portion 7a and the inside of the other end seal portion 7b, the transparent top sheet 4 and the sterilization gas permeable bottom sheet 3 are fused only at one side end fastening portion 14 and the other side end fastening portion 15, and between the inside of one end seal portion 7a and the inside of the other end seal portion 7b, the inward protrusions 33 and 34 on both sides are folded as shown in Figure 5 and maintain their inward protrusions. As a result, the entire inward protrusions 33 and 34 contribute to the inflow and outflow of sterilization gas.

[0035] 1, 2, 3, and 6, the medical device package 1 of this embodiment has an unsealed portion 19 extending across almost the entire width or the entire width at one longitudinal end of the medical device package 1. The unsealed portion 19 is located outside (above) the sealed portion 7a at one end and is parallel to the sealed portion 7a at one end. The top sheet 4 can be peeled off by gripping the unsealed portion 19.

[0036] Furthermore, the medical device package 1 of this embodiment has a slit 27 at one end (the upper end in Figs. 1 and 2) of the medical device package 1. The tip of this slit 27 reaches the central seal 11 and is located within the central seal 11. This makes it possible to tear the medical device package 1 using the slit 27.

[0037] The medical device package and medical device packaging bag of the present invention may be a medical device package 1a and a medical device packaging bag 2a as shown in Fig. 7. The basic configuration of the medical device package 1a and the medical device packaging bag 2a of this embodiment is the same as the medical device package 1 and the medical device packaging bag 2 described above, and the only difference is the shape of the one-side fastening portion 12 (17) and the other-side fastening portion 13 (18).

[0038] In this embodiment, as shown in Figure 7, the facing portions of the inward protrusions 33, 34 in the folded state are not fixed to the one side fixing portion 12 (17) and the other side fixing portion 13 (18). Therefore, as shown in Figure 7, the inward protrusions 33, 34 can be opened at the one side fixing portion 12 (17) and the other side fixing portion 13 (18).

[0039] In this embodiment as well, as shown in FIG. 7, the portions of the one side fixing portion 12 (17) and the other side fixing portion 13 (18) that face the inward protruding portions 33, 34 and the bottom surface portion 31 are fixed.

[0040] 7, in this embodiment as well, the apexes of the valleys 35, 36 of the inward protrusions 33, 34 within the storage compartment 8 are fused to the ends of the fused parts between the transparent upper sheet 4 and the bottom surface 31 of the sterilization gas-permeable lower sheet 3. In other words, near the apexes of the valleys 35, 36 of the inward protrusions 33, 34, there are fused ends where the transparent upper sheet 4 and the bottom surface 31 of the sterilization gas-permeable lower sheet 3 are directly fused, and these fused ends are also airtightly fused to the apexes of the valleys 35, 36 of the inward protrusions 33, 34.

[0041] The medical device package and medical device packaging bag of the present invention may be a medical device package 1b and a medical device packaging bag 2b as shown in Figures 8 and 9. The basic configurations of the medical device package 1b and the medical device packaging bag 2b of this embodiment are the same as those of the medical device package 1 and the medical device packaging bag 2 described above, with the only differences being the shapes of the one-side fastening portion 12 (17) and the other-side fastening portion 13 (18) and the way the medical device 6 is stored.

[0042] In the medical device package 1b and medical device packaging bag 2b of this embodiment, similar to those shown in Figure 7, the facing portions of the inward protrusions 33, 34 in the folded state are not fixed at the one side fastening portion 12 (17) and the other side fastening portion 13 (18) of the packaging bag 2b. Therefore, as shown in Figure 10, the inward protrusions 33, 34 can be opened at the one side fastening portion 12 (17) and the other side fastening portion 13 (18).

[0043] Furthermore, in the medical device package 1b of this embodiment, the medical device 6 is placed on the sheet 5 and stored in the packaging bag 2b while being partially held by the sheet 5. The inner portion of the packaging bag 2b, including the valleys of the inward protrusions 33, 34, is positioned on the side edge of the sheet 5 that holds the medical device, which is the medical item. This allows the width (distance between sides) of the packaging bag 2b to be smaller than the width (distance between sides) of the sheet 5, and therefore the width (distance between sides) of the medical device package 1b can be made smaller.

[0044] Furthermore, in all of the above-described embodiments, the medical device package and medical device packaging bag of the present invention may be provided with a sterilization gas-permeable inward protrusion 34 on only one side, extending in the longitudinal direction of the side and protruding inward of the medical device package 1c, as in the medical device package 1c and medical device packaging bag 2c shown in Figure 11. In this embodiment, the transparent upper sheet 4 and the sterilization gas-permeable lower sheet 3 on the other side are fused together at the other side edge. [Explanation of symbols]

[0045] 1 Medical device packaging 2. Medical equipment packaging bags 3 Sterile gas-permeable bottom sheet 4 Transparent top sheet 5 seats 6 Medical equipment 7 Heat seal section 31 Bottom part 33,34 Inward protrusion 35,36 Valley

Claims

1. A medical device package comprising a medical device and a sealed medical device packaging bag containing the medical device, the medical device package being gas sterilized, The medical device packaging bag comprises a sterilization gas-permeable lower sheet and a transparent upper sheet laminated on top of the sterilization gas-permeable lower sheet, a sterilization gas-permeable lower sheet having a bottom surface and opposing side surfaces extending upward from the bottom surface, at least one of the side surfaces having a sterilization gas-permeable inward protrusion extending in the longitudinal direction of the side surface and protruding toward the inside of the medical device package; and the transparent upper sheet and the sterilization gas-permeable lower sheet being sealed together with a heat seal formed around the entire periphery or near the periphery.

2. 2. The medical device package according to claim 1, wherein each of the opposing side portions has a sterilization gas permeable inward protrusion extending in the longitudinal direction of the side portion and protruding inwardly of the medical device package.

3. The medical device package according to claim 1 or 2, wherein the inward protrusion has a valley extending longitudinally through the center of the side portion.

4. 3. The medical device package according to claim 1, wherein one end and the other end in the longitudinal direction of the medical device package are heat-sealed at all of the ends of the side portions including the inward protrusion.

5. 4. The medical device package according to claim 3, wherein one and the other longitudinal ends of the medical device package are heat-sealed at all of the side edges, including the inward protrusion, and the apex of the valley of the inward protrusion within the storage compartment is fused to the end of the fused portion between the transparent upper sheet and the bottom surface of the sterilization gas-permeable lower sheet.

6. 3. The medical device package according to claim 1, wherein the medical device is a catheter.

7. 7. The medical device package according to claim 6, wherein the catheter is placed on the upper surface of the sheet and is held by the sheet.

8. A medical device packaging bag having a storage section for medical devices and to be gas sterilized after sealing, the medical device packaging bag comprising a sterilization gas-permeable bottom sheet and a transparent top sheet laminated on and fused to the top of the sterilization gas-permeable bottom sheet, The sterilization gas-permeable lower sheet has a bottom surface and opposing side surfaces extending upward from the bottom surface, and at least one of the side surfaces has a sterilization gas-permeable inward protrusion extending in the longitudinal direction of the side surface and protruding inward of the packaging bag.

9. 9. The medical device packaging bag according to claim 8, wherein each of the opposing side portions has a sterilization gas permeable inward protrusion extending in the longitudinal direction of the side portion and protruding inward of the packaging bag.

10. 10. The medical device packaging bag according to claim 8, wherein the inward protrusion has a valley extending longitudinally through the center of the side portion.

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