Packaging material for sterilization

Abstract

The present invention provides a packaging material for sterilization comprising: a tray 2 accommodating a medical instrument M; and a sterilization bag accommodating the tray 2. The tray 2 has a container part 6 accommodating the medical instrument M and a sidewall part 8 provided around the container part 6. The sterilization bag has a first portion that at least faces an outer surface of the container part 6 and is capable of transmitting a sterilizing gas, and a second portion that at least faces an inner surface 6b of the container part 6 and has a lower permeability of the sterilizing gas than the first portion. The tray 2 has a communicating part 16 that extends from the outer surface to the inner surface 6b to connect the inside and the outside of the container part 6, or extends from the sidewall part 8 to the inner surface 6b to connect the inside and the outside of the container part 6.

Description

Sterilization packaging material

[0001] The present disclosure relates to sterilization packaging.

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

[0003] Japanese Patent Application Laid-Open No. 2008-104757

[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.

[0006] One aspect of the present disclosure is a sterilization packaging material. This sterilization packaging material includes a tray for containing medical instruments and a sterilization bag for containing the tray. The tray has a container portion for containing the medical instruments and a side wall portion surrounding the container portion. The sterilization bag has at least a first portion facing the outer surface of the container portion and permeable to sterilization gas, and a second portion facing at least the inner surface of the container portion and having a 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.

[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.

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

[0009] Fig. 1 is a perspective view showing how medical instruments are contained in a sterilization packaging material according to an embodiment; Fig. 2 is a cross-sectional view schematically showing how medical instruments are contained in a sterilization packaging material; Fig. 3 is a perspective view of a portion of a tray; Fig. 4 is a cross-sectional view of a tray; Fig. 5 is a perspective view of a tray according to a first modified example;

[0010] The present disclosure will be described below with reference to the drawings based on preferred embodiments. 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 represent 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 the 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, as an example. The tray 2 includes a container 6 and a sidewall 8. The container 6 has a recess for accommodating the medical instruments M. The sidewall 8 is provided around the container 6. For ease of explanation, this disclosure defines the tray 2 in a reference position when the opening of the recess in the container 6 faces upward, 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 assume any position. In this embodiment, the sidewall 8 hangs down from the upper edge of the container 6. Like the second portion 12 described below, the tray 2 has low permeability to the sterilization gas G, and, for example, is substantially impermeable to the sterilization gas G. Examples of materials constituting 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 and the lower end of the side wall 8 of the container portion 6 are covered by the first portion 10, and the inner surface 6b of the container portion 6 and the upper end of the side wall 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 into 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 portion 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 presentation box 14, and after the sterilization process is performed, the sterilization packaging material 1 may be placed in the presentation box 14. Also, placing the sterilization packaging material 1 in the presentation 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-holes 18 and the first grooves 20. The tray 2 has communication portions 16 that communicate 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 grooves 20 are provided in the upper edge, i.e., the upper end, of the container portion 6 and extend from the side wall portion 8 to the inner surface 6b. The first grooves 20 can also be interpreted as recesses in the upper edge of the container portion 6 and the upper end of the side wall portion 8.

[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 instruments 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 instruments M through the second part 12.

[0019] In contrast, the tray 2 of this embodiment has through holes 18 in 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 sterilization 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 sterilization 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 sterilization gas G via the first groove 20. However, even if the first portion 10 does not overlap with the first groove 20, i.e., 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 sterilization 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 part 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 sterilization gas G in the gap between the medical instrument M and the container 6, at least during sterilization processing. 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 instruments 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, which allows the sterilization gas G that has permeated the first portion 10 to 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 notch 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 notch 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. Figures 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 distal end of the shaft 32. A grip portion (not shown) is connected to the proximal 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 fluid or the like.

[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 containing medical instruments M and a side wall portion 8. The sterilization bag 4 of this embodiment also has a first portion 10 that faces the outer surface 6a of the container portion 6 and is permeable to sterilization gas G, and a second portion 12 that faces the inner surface 6b of the container portion 6 and has low permeability to 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 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 connects 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 connects 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 allow the sterilization gas G to come into contact with the medical instrument M more easily. 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) Figure 5 is a perspective view of a tray 2 according to Variation 1. The tray 2 according to this variation has a lid member 40. The lid member 40 is detachably fixed to the container 6 so as to cover the support portion 22 and the gas storage portion 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 viewed 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 communication portion 16 such as the through-hole 18 or the first groove 20 in the tray 2, 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 portion 6.

[0034] (Other Modifications) 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, the 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 circumference 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 formed as 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 covering at least the first outer surface and a second portion 12 covering the opening of the storage unit. The tray 2 has a communication portion extending from the first outer surface to the first inner surface to communicate between the inside and outside of the storage unit, or extending from the second outer surface to the second inner surface to communicate between the inside and outside of the storage unit. The communication portion extending from the first outer surface to the first inner surface corresponds to the through-hole 18. The communication portion extending 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 connects 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 provided in the outer edge portion 28 and connected to the second groove 26.

[0038] The embodiments may be specified by the following items. [Item 1] A sterilization packaging material (1) comprising: a tray (2) for storing medical instruments (M); and a sterilization bag (4) for storing the tray (2), wherein the tray (2) has a container portion (6) for storing the medical instruments (M) and a side wall portion (8) provided around the container portion (6), wherein the sterilization bag (4) has a first portion (10) facing at least the outer surface (6a) of the container portion (6) and capable of passing through a sterilization gas (G), and a second portion (12) facing at least the inner surface (6b) of the container portion (6) and having a lower permeability to the sterilization gas (G) than the first portion (10), and wherein the tray (2) has a communication portion (16) extending from the outer surface (6a) to the inner surface (6b) to communicate between the inside and outside of the container portion (6), or extending from the side wall portion (8) to the inner surface (6b) to communicate between the inside and outside of the container portion (6). [Item 2] The sterilization packaging material (1) of Item 1, wherein the container portion (6) has a support portion (22) that contacts and supports the medical instrument (M) and a gas storage portion (24) that is spaced from the medical instrument (M) and stores a sterilization gas (G), and the communication portion (16) is connected to the gas storage portion (24). [Item 3] The sterilization packaging material (1) of Item 1 or Item 2, wherein the communication portion (16) includes a first groove (20) provided on the upper edge of the container portion (6), and the side wall portion (8) has a second groove (26) that extends from the lower end side to the upper end side of the side wall portion (8) and is connected to the first groove (20). [Item 4] The sterilization packaging material (1) of Item 3, wherein the tray (2) has an outer edge (28) protruding from the side wall (8) in a direction away from the container portion (6), and the outer edge (28) has a notch (30) connected to the second groove (26). [Item 5] The sterilization packaging material (1) of Item 2, wherein 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 reservoir (24).

[0039] The present disclosure can be used for sterilization packaging materials.

[0040] REFERENCE SIGNS LIST 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 Lumen, 38 Opening, G Sterilization gas, M Medical instrument.

Claims

1. A sterilization packaging material comprising: a tray for storing medical instruments; and a sterilization bag for storing the tray, wherein 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 facing at least the outer surface of the container portion and allowing sterilization gas to pass through, and a second portion facing at least the inner surface of the container portion and having a lower sterilization gas permeability than the first portion, and the tray has a communication portion extending from the outer surface to the inner surface to communicate between the inside and outside of the container portion, or extending from the side wall portion to the inner surface to communicate between the inside and outside of the container portion.

2. The sterilization packaging material according to claim 1, wherein 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 apart from the medical instrument and stores the sterilization gas, and the communication portion is connected to the gas storage portion.

3. A sterilization packaging material as described in claim 1 or 2, wherein the communicating portion includes a first groove provided on the upper edge of the container portion, and the side wall portion has a second groove extending from the lower end side to the upper end side of the side wall portion and connected to the first groove.

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

5. The sterilization packaging material according to claim 2, wherein the medical instrument is an elongated member having an inner cavity, and the opening of the inner cavity is housed in the gas reservoir.

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