Packaging material for sterilization

Abstract

To improve certainty of sterilization of a medical instrument.SOLUTION: The packaging material for sterilization includes a tray 2 for storing a medical instrument M, and a sterilization bag for storing the tray 2. The tray 2 has a container part 6 for housing the medical apparatus M and a side wall part 8 provided around the container part 6. The sterilizing bag has a first part which faces at least the outer surface of the vessel part 6 and is permeable to the sterilizing gas, and a second part which faces at least the inner surface 6b of the vessel part 6 and is less permeable to the sterilizing gas than the first part. The tray 2 has a communication part 16 extending from the outer surface to the 6b of the inner surface to communicate the inside and outside of the vessel part 6, or extending from the sidewall part 8 to the 6b of the inner surface to communicate the inside and outside of the vessel part 6.SELECTED DRAWING: Figure 3

Description

[Technical Field]

[0001] The present disclosure relates to sterilization packaging. [Background technology]

[0002] Medical instruments such as catheters have sometimes been housed in sterilization bags while being fitted into trays (see, for example, Patent Document 1). [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Japanese Patent Application Laid-Open No. 2008-104757 Summary of the Invention [Problem to be solved by the invention]

[0004] When medical instruments are contained in a sterilization packaging material including a tray and a sterilization bag, they are sterilized by supplying a sterilization gas from outside into the packaging material while they are contained in the sterilization packaging material. However, the sterilization bag sometimes has a transparent film covering the medical instruments so that the medical instruments can be seen from the outside. This transparent film tends to have low permeability to the sterilization gas. Therefore, the sterilization gas enters the sterilization bag mainly through the portion of the sterilization bag that covers the tray. After extensive research into the sterilization of medical instruments using such sterilization packaging materials, the inventors have come to the conclusion that there is room for improvement in the reliability of sterilization of medical instruments in conventional sterilization packaging materials.

[0005] The present disclosure has been made in light of these circumstances, and its purpose is to provide a technique for improving the reliability of sterilization of medical instruments. [Means for solving the problem]

[0006] One aspect of the present disclosure is a sterilization packaging material. This sterilization packaging material includes a tray for storing medical instruments and a sterilization bag for storing the tray. The tray has a container portion for storing the medical instruments and a side wall portion surrounding the container portion. The sterilization bag has a first portion that faces at least the outer surface of the container portion and is permeable to sterilization gas, and a second portion that faces at least the inner surface of the container portion and is less permeable to sterilization gas than the first portion. The tray has a communication portion that extends from the outer surface to the inner surface to communicate between the inside and outside of the container portion, or that extends from the side wall portion to the inner surface to communicate between the inside and outside of the container portion.

[0007] Any combination of the above components, and conversion of the expression of the present disclosure into a method, device, system, etc., are also valid aspects of the present disclosure. [Effects of the Invention]

[0008] According to the present disclosure, the reliability of sterilization of medical instruments can be improved. [Brief explanation of the drawings]

[0009] [Figure 1] 1 is a perspective view showing a state in which medical instruments are contained in a sterilization packaging material according to an embodiment. FIG. [Figure 2] FIG. 2 is a cross-sectional view schematically showing a state in which medical instruments are housed in a packaging material for sterilization. [Figure 3] FIG. 2 is a perspective view of a portion of the tray. [Figure 4] FIG. [Figure 5] FIG. 10 is a perspective view of a tray according to a first modified example. DETAILED DESCRIPTION OF THE INVENTION

[0010] The present disclosure will be described below with reference to preferred embodiments and drawings. The embodiments are illustrative and do not limit the present disclosure, and all features and combinations thereof described in the embodiments are not necessarily essential to the present disclosure. The same or equivalent components, parts, and processes shown in each drawing are designated by the same reference numerals, and redundant descriptions will be omitted where appropriate. The scale and shape of each part shown in each drawing are set for convenience to facilitate explanation and should not be interpreted as limiting unless otherwise specified. Furthermore, when terms such as "first" and "second" are used in this specification or claims, unless otherwise specified, these terms do not indicate any order or importance, but are intended to distinguish one configuration from another. Furthermore, some components that are not important for explaining the embodiments are omitted from each drawing.

[0011] Fig. 1 is a perspective view showing a state in which medical instruments M are contained in a sterilization packaging material 1 according to an embodiment. Fig. 2 is a cross-sectional view schematically showing a state in which medical instruments M are contained in a sterilization packaging material 1. Note that Fig. 2 shows a cross section perpendicular to the longitudinal direction of the medical instruments M. Also, Fig. 2 does not show the communication part 16. The sterilization packaging material 1 includes a tray 2 and a sterilization bag 4.

[0012] The tray 2 accommodates medical instruments M. The medical instruments M accommodated in the tray 2 are, but are not limited to, elongated members with a lumen, such as catheters, for example. The tray 2 has a container portion 6 and a side wall portion 8. The container portion 6 has a recess for accommodating the medical instruments M. The side wall portion 8 is provided around the container portion 6. For convenience of explanation, this disclosure defines the state in which the opening of the recess of the container portion 6 faces upward as the reference position of the tray 2, and describes the structure of each part when the tray 2 is in the reference position. In an actual usage environment, the tray 2 can take any position. In this embodiment, the side wall portion 8 hangs down from the upper edge of the container portion 6. Like the second portion 12 described below, the tray 2 has low permeability to the sterilization gas G, and as an example, is substantially impermeable to the sterilization gas G. Examples of materials that can be used to construct the tray 2 include synthetic resins such as polystyrene (PS) and polyethylene terephthalate (PET). The container portion 6 and the side wall portion 8 can be integrally formed by a known forming method such as press forming, vacuum forming, injection molding, etc. The structure of the tray 2 will be described in detail later.

[0013] The sterilization bag 4 accommodates the tray 2 containing the medical instruments M. The sterilization bag 4 has a first portion 10 facing at least the outer surface 6a of the container portion 6 and a second portion 12 facing at least the inner surface 6b of the container portion 6. The inner surface 6b of the container portion 6 faces the recess in which the medical instruments M are accommodated, in other words, defines the recess. Therefore, the second portion 12 overlaps the medical instruments M accommodated in the container portion 6. The outer surface 6a of the container portion 6 faces the opposite side from the inner surface 6b. In other words, the outer surface 6a is the outer surface of the recess, and the inner surface 6b is the inner surface of the recess. The outer surface 6a can also be interpreted as the bottom surface of the tray 2. As an example, the outer surface 6a of the container portion 6 and the lower end side of the side wall portion 8 are covered by the first portion 10, and the inner surface 6b of the container portion 6 and the upper end side of the side wall portion 8 are covered by the second portion 12.

[0014] The first portion 10 is made of a material that is permeable to the sterilization gas G. Examples of materials that can be used to make the first portion 10 include known nonwoven fabrics such as Tyvek (registered trademark) (manufactured by DuPont). The second portion 12 is made of a material that is less permeable to the sterilization gas G than the first portion 10. As an example, the second portion 12 is substantially impermeable to the sterilization gas G. The second portion 12 is preferably transparent to visible light, allowing the medical instruments M in the sterilization bag 4 to be viewed through the second portion 12. Examples of materials that can be used to make the second portion 12 include synthetic resins such as polyethylene terephthalate (PET) and polyethylene (PE).

[0015] The sterilization bag 4 containing the medical instruments M and the tray 2 is placed in a cosmetic box 14. In this state, the medical instruments M are sterilized. In one example of the sterilization process, the cosmetic box 14 containing the medical instruments M and the sterilization packaging material 1 is placed in a sterilization tank of a known gas sterilizer (not shown), and sterilization gas G is supplied into the sterilization tank. Examples of the sterilization gas G include known gases such as ethylene oxide gas (EOG) and formaldehyde gas. The sterilization gas G enters the cosmetic box 14 through gaps in the cosmetic box 14. It then passes mainly through the first portion 10 and enters the sterilization bag 4, and reaches the medical instruments M through the gap between the tray 2 and the sterilization bag 4 and the communication part 16, which will be described later. The sterilization gas G comes into contact with the medical instruments M, sterilizing the medical instruments M.

[0016] The sterilization packaging material 1 containing the medical instruments M may be inserted into a gas sterilizer before being placed in the cosmetic box 14, and after the sterilization process is performed, the sterilization packaging material 1 may be placed in the cosmetic box 14. Also, placing the sterilization packaging material 1 in the cosmetic box 14 may be omitted.

[0017] Next, the structure of the tray 2 will be described in detail. FIG. 3 is a perspective view of a portion of the tray 2. FIG. 4 is a cross-sectional view of the tray 2. FIG. 4 shows a cross section perpendicular to the longitudinal direction of the medical instrument M and passing through the through-hole 18 and the first groove 20. The tray 2 has a communication portion 16 that communicates between the inside and outside of the container portion 6. As an example, the tray 2 has a plurality of communication portions 16. Some of the communication portions 16 are formed by through-holes 18, and other communication portions 16 are formed by first grooves 20. The through-holes 18 are provided in the bottom of the container portion 6 and extend from the outer surface 6a to the inner surface 6b of the container portion 6. The first groove 20 is provided in the upper edge, i.e., the upper end, of the container portion 6 and extends from the side wall portion 8 to the inner surface 6b. The first groove 20 can also be interpreted as a portion where the upper edge of the container portion 6 and the upper end of the side wall portion 8 are recessed downward.

[0018] During sterilization, when sterilization gas G is injected into the sterilization furnace, the pressure of the sterilization gas G presses the sterilization bag 4 against the tray 2. Furthermore, prior to the injection of sterilization gas G, the sterilization furnace is evacuated to create a reduced pressure state. This evacuation also presses the sterilization bag 4 against the tray 2. This can cause the first part 10 to stick to the tray 2, blocking the flow path of the sterilization gas G from the first part 10 to the medical instrument M. The second part 12 has a lower permeability to the sterilization gas G than the first part 10. Therefore, it cannot be expected that a sufficient amount of sterilization gas G will reach the medical instrument M through the second part 12.

[0019] In contrast, the tray 2 of this embodiment has through-holes 18 on the bottom surface of the container portion 6. This ensures a flow path for the sterilizing gas G from the first portion 10 to the medical instruments M via the through-holes 18, even if the first portion 10 sticks to the tray 2. This allows the sterilizing gas G to come into contact with the medical instruments M more reliably.

[0020] The tray 2 also has a first groove 20 on the upper edge of the container portion 6. This ensures a flow path for the sterilizing gas G from the first portion 10 to the medical instrument M via the first groove 20, even if the first portion 10 sticks to the tray 2. This allows the sterilizing gas G to more reliably contact the medical instrument M. The first portion 10 preferably overlaps with the first groove 20 on the side wall portion 8. This makes it easier to ensure a flow path for the sterilizing gas G via the first groove 20. However, even if the first portion 10 does not overlap with the first groove 20, that is, even if the second portion 12 overlaps with the first groove 20, the presence of the first groove 20 shortens the path from the first portion 10 to the medical instrument M. This increases the likelihood that the sterilizing gas G will reach the medical instrument M via the first groove 20.

[0021] The width of the first groove 20, i.e., the dimension in the direction perpendicular to the direction in which the inner surface 6b and the side wall 8 of the container portion 6 are aligned, is smaller than the length of the first groove 20, i.e., the dimension from the inner surface 6b to the side wall 8. The width of the first groove 20 is, for example, 2 mm or more and 5 mm or less. In this way, by making the width of the first groove 20 narrower than the length, it is possible to prevent the sterilization bag 4 from entering the first groove 20. This makes it easier to ensure a flow path for the sterilization gas G from the first portion 10 to the medical instrument M.

[0022] The container 6 also has a support portion 22 and a gas storage portion 24. The support portion 22 contacts and supports the medical instrument M. The gas storage portion 24 is spaced apart from the medical instrument M and stores sterilizing gas G in the gap between the medical instrument M and the container 6, at least during sterilization. At least some of the communication portions 16 are connected to the gas storage portion 24. The container 6 of this embodiment has multiple gas storage portions 24 arranged at predetermined intervals in the longitudinal direction of the medical instrument M. Each gas storage portion 24, except for the gas storage portion 24 located at the extreme end of the tray 2, is connected to one through-hole 18 and two first grooves 20. The distal end of the medical instrument M is accommodated in the distal gas storage portion 24. Three first grooves 20 are connected to the gas storage portion 24. The gas storage portion 24 in which the distal end of the medical instrument M is accommodated may also be provided with a through-hole 18.

[0023] By connecting the communication part 16 to the gas storage part 24, the sterilizing gas G can be more reliably supplied to the gas storage part 24. This allows the sterilizing gas G to come into contact with the medical instrument M more reliably.

[0024] The side wall 8 also has a second groove 26. The second groove 26 extends from the lower end to the upper end of the side wall 8 and is connected to the first groove 20. The second groove 26 is recessed toward the container 6. Therefore, even if the sterilization bag 4 adheres to the side wall 8, the second groove 26 is unlikely to be blocked. Therefore, the side wall 8 has the second groove 26, so that the sterilization gas G that has permeated the first portion 10 can be sent to the first groove 20 via the second groove 26. This makes it easier to ensure a flow path for the sterilization gas G from the first portion 10 to the medical instrument M.

[0025] The tray 2 also has an outer edge 28. The outer edge 28 protrudes from the side wall 8 in a direction away from the container 6. The outer edge 28 also has a cutout 30 connected to the second groove 26. In this embodiment, the outer edge 28 is provided around approximately the entire circumference of the tray 2 and protrudes from the lower end of the side wall 8. The outer edge 28 is also recessed toward the container 6 at the cutout 30. The outer edge 28 prevents the sterilization bag 4 from sticking to the side wall 8. The cutout 30 is provided at a position where the outer edge 28 overlaps with the second groove 26, allowing the sterilization gas G that has permeated the first portion 10 to be sent to the second groove 26 via the cutout 30. This makes it easier to ensure a flow path for the sterilization gas G from the first portion 10 to the medical instrument M.

[0026] As described above, an example of the medical device M is an elongated member having a lumen 34. FIGS. 3 and 4 show, as an example of the medical device M, a catheter having an electrode assembly 36 attached to a shaft 32. The shaft 32 has a lumen 34 extending over substantially the entire length of the shaft 32. The shaft 32 has, as an example, a plurality of lumens 34. The electrode assembly 36 is connected to the tip of the shaft 32. A grip (not shown) is connected to the base end of the shaft 32.

[0027] An example of the electrode assembly 36 includes a plurality of splines arranged around the axis of the shaft 32, and an electrode provided on each spline. Some of the lumens 34 accommodate wires (not shown) extending from the electrodes and shafts (not shown) for opening and closing the splines. Other lumens 34 can be used as passages for irrigation fluids, etc.

[0028] The electrode assembly 36 and the opening 38 of the lumen 34 are housed in the gas reservoir 24. In this embodiment, the opening 38 is provided at the tip of the shaft 32, and the opening 38 is also housed in the gas reservoir 24 that houses the electrode assembly 36. By arranging the opening 38 in the gas reservoir 24 in this way, it is possible to make it easier for the sterilization gas G to flow into the lumen 34.

[0029] As described above, the tray 2 of this embodiment has a container portion 6 for accommodating medical instruments M and a side wall portion 8. The sterilization bag 4 of this embodiment has a first portion 10 that faces the outer surface 6a of the container portion 6 and is permeable to the sterilization gas G, and a second portion 12 that faces the inner surface 6b of the container portion 6 and has low permeability to the sterilization gas G. The tray 2 also has a communication portion 16 that extends from the outer surface 6a to the inner surface 6b to communicate between the inside and outside of the container portion 6, or that extends from the side wall portion 8 to the inner surface 6b to communicate between the inside and outside of the container portion 6. This makes it easier for the sterilization gas G to reach the medical instruments M even if the first portion 10 sticks to the tray 2 during sterilization. This improves the reliability of sterilization of the medical instruments M.

[0030] The container 6 also has a support portion 22 that supports the medical instrument M and a gas storage portion 24 that stores the sterilization gas G. The communication portion 16 is connected to the gas storage portion 24. At least a portion of the communication portion 16 is formed by a first groove 20 provided on the upper edge of the container 6. The side wall 8 has a second groove 26 that extends from the lower end to the upper end of the side wall 8 and is connected to the first groove 20. The tray 2 also has an outer edge portion 28 that protrudes from the side wall 8. The outer edge portion 28 has a notch 30 that is connected to the second groove 26. The medical instrument M is an elongated member having an inner cavity 34, and an opening 38 of the inner cavity 34 is contained in the gas storage portion 24. These configurations make it easier for the sterilization gas G to come into contact with the medical instrument M. This further improves the reliability of sterilization of the medical instrument M.

[0031] The embodiments of the present disclosure have been described in detail above. The above-described embodiments merely illustrate specific examples of implementing the present disclosure. The content of the embodiments does not limit the technical scope of the present disclosure, and many design modifications, such as changing, adding, or deleting components, are possible within the scope of the concept of the present disclosure defined in the claims. A new embodiment with design modifications will combine the effects of the combined embodiments and modifications. In the above-described embodiments, the content that allows such design modifications is emphasized by using notations such as "in this embodiment" or "in this embodiment," but design modifications are also permitted even in content without such notation. Any combination of the components included in each embodiment is also valid as an aspect of the present disclosure. Hatching on cross sections in the drawings does not limit the material of the hatched object.

[0032] (Variation 1) FIG. 5 is a perspective view of a tray 2 according to Modification 1. The tray 2 according to this modification has a lid member 40. The lid member 40 is detachably fixed to the container 6 so as to cover the support section 22 and the gas storage section 24 of the container 6. At least the bottom of the first groove 20 is located closer to the bottom of the container 6 than the lid member 40. The lid member 40 can prevent the medical instruments M from falling out of the container 6. Like the tray 2, the lid member 40 is made of a material that has low permeability to the sterilization gas G. The lid member 40 is also preferably transparent to visible light. This allows the medical instruments M in the sterilization bag 4 to be seen through the second portion 12 and the lid member 40.

[0033] If the lid member 40 blocks the opening of the storage space for the medical instruments M, the lid member 40 may prevent the sterilization gas G from reaching the medical instruments M. In contrast, by providing the tray 2 with the communication part 16 such as the through-hole 18 or the first groove 20, the sterilization gas G can be made to reach the medical instruments M more easily, even when the lid member 40 is attached to the container part 6.

[0034] (Other variations) In the embodiment, there is a space between the side of the container 6 and the side wall 8. In this case, a through hole 18 connecting the outer surface 6a and the inner surface 6b may be provided in the side of the container 6. Furthermore, if the space between the side of the container 6 and the side wall 8 is solid, a through hole 18 extending from the inner surface 6b of the side of the container 6 to the surface of the side wall 8 may be provided. That is, in the embodiment, a first groove 20 with an open upper end extends from the side wall 8 to the inner surface 6b of the container 6. However, in addition to or instead of this first groove 20, a through hole 18 with a closed periphery may extend from the side wall 8 to the inner surface 6b of the container 6. Furthermore, the structure of the medical device M is not limited to that described in the embodiment. For example, the electrode assembly 36 may have a structure in which electrodes are provided directly on the outer circumferential surface of the shaft 32 without having a spline.

[0035] The tray 2 according to the embodiment can also be interpreted as having the following structure. That is, the tray 2 has a bottom plate portion and side plate portions. The bottom plate portion has a first outer surface and a first inner surface that face each other. The side plate portions have a second outer surface and a second inner surface that face each other and rise from the periphery of the first inner surface. The tray 2 also has a storage section that is partitioned by the first inner surface and the second inner surface and that stores medical instruments M.

[0036] The bottom plate portion corresponds to the bottom of the container portion 6. The first outer surface corresponds to the outer surface 6a of the bottom of the container portion 6, and the first inner surface corresponds to the inner surface 6b of the bottom of the container portion 6. The side plate portion corresponds to the side portion and side wall portion 8 of the container portion 6. In particular, when the space between the side portion and the side wall portion 8 of the container portion 6 is solid, it can be said that the side portion and the side wall portion 8 of the container portion 6 are integrally constituting the side plate portion. Conversely, when the tray 2 has one side plate portion on the outer periphery of the bottom plate portion, this side plate portion can be interpreted as including the side portion and the side wall portion 8 of the container portion 6. The second outer surface corresponds to the surface of the side wall portion 8, and the second inner surface corresponds to the inner surface 6b of the side portion of the container portion 6. The storage portion corresponds to the support portion 22 and the gas storage portion 24.

[0037] The sterilization bag 4 has a first portion 10 that covers at least the first outer surface and a second portion 12 that covers the opening of the storage unit. The tray 2 has a communication portion that extends from the first outer surface to the first inner surface to communicate between the inside and outside of the storage unit, or that extends from the second outer surface to the second inner surface to communicate between the inside and outside of the storage unit. The communication portion that extends from the first outer surface to the first inner surface corresponds to the through-hole 18. The communication portion that extends from the second outer surface to the second inner surface corresponds to the first groove 20. The tray 2 also has a second groove 26 on the second outer surface that extends from the lower end to the upper end of the side plate and is connected to the communication portion, an outer edge portion 28 that protrudes from the second outer surface of the side plate, and a notch portion 30 that is provided in the outer edge portion 28 and is connected to the second groove 26.

[0038] The embodiments may be specified by the following items. [1st item] a tray (2) for accommodating medical instruments (M); a sterilization bag (4) for containing the tray (2); The tray (2) has a container portion (6) for accommodating the medical instrument (M) and a side wall portion (8) provided around the container portion (6), The sterilization bag (4) has a first part (10) that faces at least the outer surface (6a) of the container part (6) and is permeable to the sterilization gas (G), and a second part (12) that faces at least the inner surface (6b) of the container part (6) and has lower permeability to the sterilization gas (G) than the first part (10), The tray (2) has a communication part (16) that extends from the outer surface (6a) to the inner surface (6b) to communicate between the inside and outside of the container part (6) or that extends from the side wall part (8) to the inner surface (6b) to communicate between the inside and outside of the container part (6). Sterilization packaging material (1). [Second item] The container (6) has a support part (22) that contacts the medical instrument (M) and supports the medical instrument (M), and a gas storage part (24) that is spaced from the medical instrument (M) and stores a sterilizing gas (G), The communication portion (16) is connected to the gas storage portion (24). Item 1: Sterilization packaging materials (1). [3rd item] The communication portion (16) includes a first groove (20) provided on the upper edge of the container portion (6), The side wall portion (8) has a second groove (26) extending from the lower end side to the upper end side of the side wall portion (8) and connected to the first groove (20). Sterilization packaging material of item 1 or 2 (1). [4th item] The tray (2) has an outer edge (28) protruding from the side wall (8) in a direction away from the container portion (6), The outer edge (28) has a notch (30) connected to the second groove (26). Item 3: Sterilization packaging materials (1). [Item 5] The medical device (M) is an elongate member having an internal cavity (34), The opening (38) of the lumen (34) is received in the gas reservoir (24). Item 2: Sterilization packaging materials (1). [Explanation of symbols]

[0039] 1 sterilization packaging material, 2 tray, 4 sterilization bag, 6 container portion, 8 side wall portion, 10 first portion, 12 second portion, 16 communication portion, 20 first groove, 22 support portion, 24 gas storage portion, 26 second groove, 28 outer edge portion, 30 cutout portion, 34 inner cavity, 38 opening, G sterilization gas, M medical instrument.

Claims

1. a tray for storing medical instruments; a sterilization bag that contains the tray; The tray has a container portion that accommodates the medical instrument and a side wall portion that is provided around the container portion, The sterilization bag has a first portion that faces at least the outer surface of the container portion and is permeable to sterilization gas, and a second portion that faces at least the inner surface of the container portion and has lower permeability to sterilization gas than the first portion, The tray has a communication portion that extends from the outer surface to the inner surface to communicate between the inside and outside of the container portion, or that extends from the side wall portion to the inner surface to communicate between the inside and outside of the container portion. Packaging material for sterilization.

2. the container portion has a support portion that contacts the medical instrument and supports the medical instrument, and a gas storage portion that is spaced from the medical instrument and stores the sterilizing gas, The communication portion is connected to the gas storage portion. The sterilization packaging material according to claim 1.

3. the communication portion includes a first groove provided on an upper edge of the container portion, The side wall portion has a second groove extending from a lower end side to an upper end side of the side wall portion and connected to the first groove. The sterilization packaging material according to claim 1 or 2.

4. the tray has an outer edge portion protruding from the side wall portion in a direction away from the container portion, The outer edge portion has a notch portion connected to the second groove. The sterilization packaging material according to claim 3.

5. the medical device is an elongate member having a lumen; The opening of the lumen is accommodated in the gas reservoir. The sterilization packaging material according to claim 2.

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