The present invention relates to a transport container. More specifically, the present invention relates to a transport container, a transport container having a holder, and a packed transport container, which are capable of stably holding a medical device.
Generally, a medical device is sterilized with housed in a container, and is transported and stored in a sterilized state. However, there is a probability that a sanitary problem is caused because the medical device itself is damaged due to vibration of the medical device in the container upon transport or microparticles are caused by scratching or friction due to contact of, e.g., the medical device or a holder holding the medical device with the inner surface of the container.
In order to solve the above-described problem, there has been proposed a method for reducing vibration of the medical device upon transport by fixing the medical device in the container. For example, PTL 1 discloses, as a medical equipment container transportable with included medical equipment fixed, a medical equipment container configured such that a holder holding at least one piece of medical equipment is included in a container body having an opening at an upper portion and the opening is sealed with a gas impermeable film. The medical equipment container is characterized in that the internal pressure of the medical equipment container is lower than an atmospheric pressure.
However, the related art is not enough yet, and there has been a situation where further development is demanded not only for a method in which a medical device is fixed with included in a holder as described in PTL 1, but also for a transport container for transporting a medical device.
For this reason, the present invention is mainly intended to provide a transport container capable of stably holding a medical device.
That is, the present invention provides a transport container for a medical device, which includes a bottom, a body, and an opening, is formed with a flange which is formed so as to extend outward from part or the entirety of a peripheral edge portion of the body, and is formed, on the bottom, with an engagement portion to be engaged with a holder holding the medical device.
The engagement portion may include a plurality of engagement portions.
The engagement portion may be in a raised shape having a recessed portion at the center. In this case, the engagement portion may in a substantially oval ring raised shape. In a case where the engagement portion is in the substantially oval ring raised shape, the aspect ratio of the recessed portion is Minor Axis:Major Axis=1:1.1 to 3.0. Moreover, in this case, when the engagement portion is in the substantially oval ring raised shape, the longitudinal direction of the opening and the major axis direction of the recessed portion may be the same identical direction.
In a case where the engagement portions include two engagement portions, the two engagement portions may be formed on a substantially diagonal line.
In the transport container according to the present invention, part of the body may have a raised portion.
The present invention also provides a transport container having a holder, which includes the holder holding a medical device and a transport container for the medical device, which includes a bottom, a body, and an opening, is formed with a flange which is formed so as to extend outward from part or the entirety of a peripheral edge portion of the body, and is formed, on the bottom, with an engagement portion to be engaged with the holder.
Further, the present invention also provides a packed transport container including the transport container having the holder and a lid detachably thermally bonded to the flange of the transport container.
According to the present invention, the transport container capable of stably holding the medical device can be provided.
Note that advantageous effects are not limited to those described here and may be any of the advantageous effects described in the present specification.
Hereinafter, a preferred embodiment of the present invention will be described with reference to the drawings.
The embodiment described below is one representative exemplary embodiment of the present invention, and is not intended to interpret the scope of the present invention as a narrower scope.
Note that in the present embodiment, the holder 50 and the medical device 20 are not necessarily included in the scope of the transport container 10 according to the present embodiment, and the transport container 10 can be distributed alone.
In the present specification, the “medical device” is a tool used in a medical field, such as a medicine container, a medicine container rubber plug, a cap, a syringe, a barrel (syringe barrel), a piston, a syringe needle, a vial, a test tube, and a tube (including a microtube), and broadly includes those housable in the transport container 10 according to the present embodiment. Moreover, in the present embodiment, the “holder” is a tool for holding the medical device 20, and broadly includes those housable in the transport container 10 according to the present embodiment. Note that the holder 50 will be described in detail in “2. Transport container 10 having holder 50.”
The shape of the transport container 10 is not particularly limited, but for example, can be a box shape. The box shape includes, for example, a shape in which the shape of the bottom 11 is a substantially circular shape, a substantially oval shape, or a substantially polygonal shape such as a substantially triangular shape or a substantially quadrangular shape (including a substantially rectangular shape), but is preferably the substantially rectangular shape in the present embodiment. Note that in a case where the shape of the bottom 11 is the substantially polygonal shape in the present embodiment, a corner thereof may be designed as a round corner.
The material of the transport container 10 is preferably selected in terms of, e.g., the material being non-toxic and clean, various sterilization methods being applicable to the material, and the material having light resistance and weather resistance. Further, in a case where the inside of the transport container 10 needs to be maintained under a more negative pressure than an atmospheric pressure, the material is preferably selected also considering oxygen permeability. Specifically, the material includes, but not particularly limited to, polypropylene, polycarbonate, polyethylene, and high-impact polystyrene, for example. The transport container 10 can be produced in such a manner that such a material is processed by a conventional well-known method. Note that the material of the transport container 10 may have transparency or translucency, but is not particularly limited in the present technique.
In response to this problem, the bottom 11 of the transport container 10 according to the present invention is formed with the engagement portion 111 to be engaged with the holder 50 holding the medical device 20. With this configuration, the movement of the medical device 20 upon, e.g., transport or use is controlled so that the contact of, e.g., the medical device 20 or the holder 50 holding the medical device 20 with the inner surface of the transport container 10 can be prevented and the medical device 20 can be stably held.
The shape of the engagement portion 111 is not particularly limited as long as the engagement portion 111 can be engaged with the holder 50, and can be designed appropriately to fit a conventional well-known engagement mechanism such as a screw mechanism, a snap-fit, or other conventional mechanisms. Moreover, the holder 50 and the engagement portion 111 are preferably detachably formed. With this configuration, the holder 50 can be easily taken out of the transport container 10, leading to improvement in usability.
As shown in
In the case of the two engagement portions 111, the two engagement portions 111 are preferably formed on a substantially diagonal line. With this configuration, as compared to a case of the engagement portions 111 being not formed on the substantially diagonal line, the movement of the medical device 20 upon, e.g., transport or use can be more controlled, and the medical device 20 can be more stably held.
A specific shape of the engagement portion 111 includes, for example, a raised shape, a recessed shape, or a partially-combined shape thereof, and the raised shape and/or the recessed shape may include, for example, a substantially circular shape, a substantially oval shape, and a substantially polygonal shape such as a substantially triangular shape or a substantially quadrangular shape (including a substantially rectangular shape). Moreover, the engagement portion 111 is not necessarily in, e.g., a continuously-formed annular raised shape and/or recessed shape as described later, and may be in, e.g., a non-continuously-formed raised shape and/or recessed shape with a cutout. Further, in the present embodiment, in a case where the raised shape and/or the recessed shape of the engagement portion 111 are the substantially polygonal shape, a corner thereof may be designed as a round corner.
The specific shape of the engagement portion 111 is preferably a raised shape having a recessed portion at the center. The recessed portion is provided at the center so that the engagement portion 111 can be easily engaged with, e.g., a support 55 of the holder 50 described later.
A more specific shape of the engagement portion 111 is preferably a substantially circular ring raised shape such as a substantially oval ring raised shape shown in
In a case where the engagement portion 111 is in the substantially oval ring raised shape, the aspect ratio of the recessed portion in an oval shape is preferably Minor Axis:Major Axis=1:1.1 to 3.0 and more preferably Minor Axis:Major Axis=1:1.3 to 2.8. With Minor Axis:Major Axis=1:1.1 or more, the recessed portion is not in a substantially circular shape, but can be in the substantially oval shape. As a result, the above-described play upon transport can be formed. Moreover, with Minor Axis:Major Axis=1:3.0 or less, a failure to handle, e.g., shaking upon transport or use due to excessive play can be prevented.
In a case where the engagement portion 111 is in the substantially oval ring raised shape, the longitudinal direction of the opening 13 and the major axis direction of the recessed portion are preferably the same direction. With this configuration, the contact of, e.g., the medical device 20 or the holder 50 holding the medical device 20 with the inner surface of the transport container 10 can be more prevented, and the medical device 20 can be more stably held.
Hereinafter, other portions of the transport container 10 according to the present embodiment will be described in detail with reference to
As described above, the transport container 10 of the embodiment shown in
As shown in
Further, as shown in
The transport container 10 having the holder 50 according to the present embodiment includes at least the holder 50 holding the medical device 20 and the transport container 10 for the medical device 20 as described above. The transport container 10 for the medical device 20 is similar to one described in “1. Transport container 10,” and therefore, description thereof will be omitted here.
In the transport container 10 having the holder 50 according to the present embodiment, the holder 50 holding the medical device 20 is preferably included inside the transport container 10. This container can be produced through a housing step of housing the holder 50 holding the medical device 20 through the opening 13 of the formed transport container 10.
The shape of the holder 50 can be designed appropriately according to, e.g., the type and size of the medical device 20, and therefore, is not particularly limited. One example will be described with reference to
As shown in
As shown in
As shown in
The holder 50 can stably hold the medical device 20 with the locking claws 531 at plural locations (for example, three locations). Moreover, in a case where the medical device 20 is a rubber plug-embedded cap, it can be configured such that when the mouth of a medicine container is plugged, the rubber plug-embedded cap is reliably released from the locking claw 531 holding such a cap.
As shown in
As shown in
As shown in
Note that a distance X (distance to the medical device 20 held by the holder 50 or the holder 50 in the transport container 10) in the partially-enlarged view of
The material of the holder 50 is preferably selected in terms of, e.g., the material being non-toxic and clean, various sterilization methods being applicable to the material, and the material having light resistance and weather resistance. Further, the material is preferably selected in terms of, e.g., the shape, material, required quality, function, and strength of the medical device 20. Specifically, the material includes, but not particularly limited to, polypropylene, polycarbonate, polyethylene, and polyacetal, for example. The holder 50 can be produced in such a manner that such a material is processed by a conventional well-known method. Note that the material of the holder 50 may have transparency or translucency, but is not particularly limited in the present technique.
A packed transport container 10 according to the present invention includes at least the transport container 10 having the holder 50 as described above and the lid 40 detachably thermally bonded to the flange 121 of the transport container 10. The transport container 10 having the holder 50 is similar to one described in “2. Transport container 10 having holder 50,” and therefore, description thereof will be omitted here.
In a case where the produced packed transport container 10 is under environment with a pressure lower than the atmospheric pressure due to, e.g., aerial transport, the internal pressure of the container may be equal to or lower than the pressure during the aerial transport. The upper limit of the internal pressure of the transport container 10 is preferably 1013 hPa or less and more preferably 980 hPa. The lower limit of the pressure may be adjusted appropriately such that the transport container 10 is not deformed or damaged, and is preferably 400 hPa or more.
The medical device 20 shown in
The lid 40 has a gas impermeable film, and is detachably thermally bonded to the flange 121 of the transport container 10. In this manner, as shown in
A method for thermally bonding the lid 40 and the flange 121 to each other can be performed by a conventional well-known method. For example, the method includes a method in which the flange 121 is melted with heat and is bonded to the lid 40, a method in which an adhesive layer forming the lid 40 is melted with heat and is bonded to the flange 121, and a method in which the lid 40 and the flange 121 are bonded to each other with an adhesive (e.g., hot-melt adhesive).
The configuration of the lid 40 is not particularly limited as long as the lid 40 has the gas impermeable film, but for example, can be a stack including (A) a gas impermeable layer, (B) an anchor coat layer, and (C) an adhesive layer in this order from the upper layer (outside). Hereinafter, a preferred material of each layer will be described in (1) to (4) in a case where a preferred configuration of the lid 40 is expressed as “(A) Gas Impermeable Layer/(B) Anchor Coat Layer/(C) Adhesive Layer” in this order from the upper layer. (1) to (3) are the lid 40 with a three-layer structure, and (4) is the lid 40 with a five-layer structure.
(1) (A) Polyethylene Terephthalate/(B) Polyethylene/(C) Polyethylene-Based Resin
(2) (A) Polyethylene Terephthalate/(B) Polyethylene/(C) Olefin-Based Resin Including Mixture of Polyethylene and Polyethylene Terephthalate
(3) (A) Polyethylene Terephthalate/(B) Polyethylene/(C) Polypropylene-Based Resin
(4) (A) Polyethylene Terephthalate/(B) Polyethylene/(B) Biaxially Oriented Nylon/(B) Polyethylene/(C) Polyethylene-Based Resin
Note that the lid 40 may include (D) a gas permeable film in addition to (A) the gas impermeable layer, (B) the anchor coat layer, and (C) the adhesive layer described above.
Preferably, in formation of the lid 40, in a case of performing sterilization treatment using gas, (D) the gas permeable film is detachably thermally bonded to the flange 121, and thereafter, the gas impermeable film or the stack including (A) the gas impermeable layer, (B) the anchor coat layer, and (C) the adhesive layer is stacked and bonded thereto. In this manner, the inside of the transport container 10 can be sterilized using the gas, and the cleanness of the inside of the transport container 10 can be more enhanced. On the other hand, in a case of performing sterilization treatment using a radiation or an electron beam, (D) the gas permeable film is not necessary, and the gas impermeable film or the stack including (A) the gas impermeable layer, (B) the anchor coat layer, and (C) the adhesive layer is preferably stacked and bonded. A bonding method is not particularly limited, and a conventional well-known method such as a method in which bonding is performed with (C) the adhesive layer or a method in which bonding is performed with an adhesive can be used.
The thickness of the lid 40 can be selected appropriately according to the configuration and material thereof. For example, in a case where the lid 40 includes the stack having (A) the gas impermeable layer, (B) the anchor coat layer, and (C) the adhesive layer, the thickness of the lid 40 is preferably 50 μm to 150 μm and more preferably 70 μm to 100 μm. In a case where the lid 40 includes the stack having (A) the gas impermeable layer, (B) the anchor coat layer, and (C) the adhesive layer and (D) the gas permeable film, the thickness of the lid 40 is preferably 200 μm to 500 μm.
In the production method according to the present embodiment, a housing step (Step S11) of housing the medical device 20 in the transport container 10 having the opening 13 and the flange 121 is first performed. The medical device 20 may be held by the holder 50. In this case, in Step S11, the holder 50 holding the medical device 20 is housed in the transport container 10.
Subsequently, a sealing step (Step S12) of sealing the opening 13 by detachably thermally bonding the lid 40 to the flange 121 and pressing the medical device 20 or the holder 50 holding the medical device 20 by the lid 40 by bringing the inside of the transport container 10 into the more negative pressure than the atmospheric pressure is performed. In Step S12, the internal pressure of the transport container 10 is decreased such that the lid 40 presses the medical device 20 or the holder 50 holding the medical device 20, and accordingly, the transport container 10 is under the more negative pressure than the atmospheric pressure.
Through Step S12, the lid 40 is thermally bonded to the transport container 10 in a state of directly pressing the medical device 20 or indirectly pressing the medical device 20 through the holder 50. In this manner, the packed transport container 10 is obtained with the medical device 20 fixed. A thermal bonding method is not particularly limited, and a conventional well-known method such as a method in which the flange 121 is melted with heat and is bonded to the lid 40, a method in which the adhesive layer of the lid 40 is melted with heat and is bonded to the flange 121, or a method in which the flange 121 and the lid 40 are bonded to each other with a component (e.g., adhesive such as a hot-melt adhesive) other than the flange 121 and the lid 40 can be used. Note that in Step S12, a specific treatment method in the present technique is not particularly limited as long as the opening 13 of the transport container 10 can be sealed and the medical device 20 can be pressed by the lid 40 as described above.
The production method according to the present embodiment preferably includes, after Step S12, a cutting step (Step S13) of cutting the lid 40. “After the sealing step” means the same timing as that of the sealing step or after the sealing step. That is, in the production method according to the present embodiment, the lid 40 is preferably cut at the same time as or after thermal bonding of the lid 40 to the flange 121 of the transport container 10. For example, when the packed transport container 10 is produced using the lid 40 larger than the outer shape of the transport container 10, such as a roll-shaped lid 40, a step of cutting the lid 40 in accordance with the shape of the transport container 10 is performed in some cases. The lid 40 is cut after the sealing step so that the lid 40 can be more reliably thermally bonded. Note that in the production method according to the present embodiment, Step S12 can be performed after Step S13. For example, in a case where the cut lid 40 is arranged under pressure-decreased environment together with, e.g., the transport container 10 and the lid 40 and the flange 121 are thermally bonded to each other, Step S12 may be performed after Step S13.
In the production method according to the present embodiment, an internal sterilization step (Step S14) of sterilizing the inside of the packed transport container 10 may be performed after Step S12. In a case of performing Step S13, Step S14 is preferably performed after Step S13. As a sterilization method in Step S14, radiation sterilization or electron beam sterilization is preferred, but the present technique is not limited thereto.
According to the present invention, a transport container capable of stably holding a medical device can be provided. Moreover, a transport container having a holder and a packed transport container can also be provided. The transport container according to the present invention is used so that movement of the medical device upon, e.g., transport or use can be controlled. As a result, contact of, e.g., the medical device or the holder holding the medical device with the inner surface of the transport container can be prevented, and the medical device can be stably held.
Number | Date | Country | Kind |
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2023-074548 | Apr 2023 | JP | national |
Filing Document | Filing Date | Country | Kind |
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PCT/JP2023/041181 | 11/16/2023 | WO |