The present invention relates to a part of an item container for a medical device for storing an item for a medical device, an item container for a medical device, a medical device storage pack, and an item for a medical device.
Containers for storing items have been widely used in various fields. As for a container for storing an item for a medical device, in particular, the interior of the container is maintained in a sterile condition.
For example, Japanese Patent Application Laid-Open Publication No. 2000-225126 discloses a medical kit container in which a sterile paper is adhered to a flange portion provided around a storage portion to seal the storage portion. Here, the flange portion is formed with a convex portion for more reliable sealing.
A medical kit is stored in the storage portion of the medical kit container, the sterile paper is adhered to the flange portion to seal the storage portion of the container, and the container is irradiated with gamma rays or electron beams to perform ethylene oxide treatment to produce a sterilized medical kit pack.
A part of an item container for a medical device according to an aspect of the present invention includes: a bulging-shape portion configured to bulge in a first direction and to store an item for a medical device in a hollow interior; a flange provided at a peripheral edge of the bulging-shape portion; a protruding-shape portion protruding from the flange in the first direction; and a concave portion provided in contact with the bulging-shape portion, wherein the protruding-shape portion is arranged at a position spaced apart from the bulging-shape portion in a second direction and is provided to extend in an elongated manner in a third direction different from the first direction and the second direction.
An item container for a medical device according to an aspect of the present invention includes: a part of an item container for a medical device including: a bulging-shape portion configured to bulge in a first direction and to store an item for a medical device in a hollow interior; a flange provided at a peripheral edge of the bulging-shape portion; a protruding-shape portion protruding from the flange in the first direction; and a concave portion provided in contact with the bulging-shape portion, wherein the protruding-shape portion is arranged at a position spaced apart from the bulging-shape portion in a second direction and is provided to extend in an elongated manner in a third direction different from the first direction and the second direction; and a seal body bonded to the part of the item container for the medical device.
A medical device storage pack according to an aspect of the present invention, includes: a part of an item container for a medical device including: a bulging-shape portion configured to bulge in a first direction and to store an item for a medical device in a hollow interior; a flange provided at a peripheral edge of the bulging-shape portion; a protruding-shape portion protruding from the flange in the first direction; and a concave portion provided in contact with the bulging-shape portion, wherein the protruding-shape portion is arranged at a position spaced apart from the bulging-shape portion in a second direction and is provided to extend in an elongated manner in a third direction different from the first direction and the second direction; the item for the medical device stored in the part of the item container for the medical device; and a seal body bonded to the part of the item container for the medical device to seal a periphery of the item for the medical device.
An item for a medical device according to an aspect of the present invention is configured to be stored in an item container for a medical device including: a part of an item container for a medical device including: a bulging-shape portion configured to bulge in a first direction and to store an item for a medical device in a hollow interior; a flange provided at a peripheral edge of the bulging-shape portion; a protruding-shape portion protruding from the flange in the first direction; and a concave portion provided in contact with the bulging-shape portion, in which the protruding-shape portion is arranged at a position spaced apart from the bulging-shape portion in a second direction and is provided to extend in an elongated manner in a third direction different from the first direction and the second direction; and a seal body bonded to the part of the item container for the medical device, wherein the item for the medical device is stored in the hollow interior of the bulging-shape portion.
Hereinafter, an embodiment of the present invention will be described with reference to the accompanying drawings. However, the present invention is not limited to the embodiment described below.
Note that in the description of the drawings, the same or corresponding elements are denoted by the same reference numerals as appropriate. In addition, it should be noted that the drawings are schematic, and a relationship between lengths of elements, a ratio of lengths of elements, and the like in one drawing may be different from actual ones. Further, a plurality of drawings may include portions having different relationships or ratios of lengths.
The item container 1 is a container for storing an item for a medical device in a sterile condition, and is configured as, for example, a blister pack. Here, the item for a medical device is a medical device, a replacement part of a medical device, an accessory of a medical device, or the like, and specific examples thereof will be described later.
The item container 1 for a medical device includes a main body 2 as a first part and a seal body 3 as a second part.
The main body 2 includes a bulging portion 10 (bulging-shape portion), a protruding portion 16 (protruding-shape portion), and a substantially planar flange portion 19 (flange) that connects the bulging portion 10 and the protruding portion 16. Here, for ease of explanation, x, y, and z directions are set as three-dimensional orthogonal directions. As illustrated in
The bulging portion 10 bulges from the flange portion 19 in the z direction (first direction) and is configured to store an item for a medical device in a hollow interior (storage portion as a concave portion).
The bulging portion 10 of the present embodiment includes a plurality of bulging portions, specifically, three bulging portions 11, 12, and 13 (bulging-shape portions), and can store three items for the medical device. However, the number of items stored in the item container 1 may be any number as long as it is one or more. Therefore, the number of bulging portions may be an arbitrary number according to the number of items.
For example, a cylindrical concave portion 14 (a concave portion having a curved surface) forming a semi-cylindrical surface is provided between the bulging portion 11 and the bulging portion 12. The cylindrical concave portion 14 connects the hollow inside the bulging portion 11 and the hollow inside the bulging portion 12. The cylindrical concave portion 14 facilitates pinching of the items each stored in the bulging portions 11 and 12 with fingers.
In addition, for example, a spherical concave portion 15 (a concave portion having a curved surface) forming about half of a hemispherical surface is provided on the protruding portion 16 side of the bulging portion 13. The spherical concave portion 15 facilitates pinching of the item stored in the bulging portion 13 with fingers.
The flange portion 19 is a substantially planar portion provided on a peripheral edge of the bulging portion 10. The flange portion 19 is provided with a stepped concave portion 18 which is a portion not bonded to the seal body 3.
The protruding portion 16 is disposed at a position spaced apart from the bulging portion 10 in the y direction (second direction) and protrudes from the flange portion 19 in the z direction (first direction). The y direction (second direction) in which the protruding portion 16 is separated from the bulging portion 10 is orthogonal to the arrangement direction of at least two bulging portions among the plurality of bulging portions 11, 12, and 13, here, the arrangement direction (x direction) of the bulging portion 11 and the bulging portion 12.
Here, a distance by which the protruding portion 16 is separated from the bulging portion 10 is such that the base of the thumb or a part of the palm of the hand of a user holding the bulging portion 10 of the item container 1 can enter between the bulging portion 10 and the protruding portion 16 (see
Specifically, similar to the bulging portion 10 described above, the protruding portion 16 is provided as another bulging portion (another bulging-shape portion) that bulges in the z direction (first direction) and has a hollow interior.
Note that since there is no need to store an item inside the protruding portion 16, it is not prohibited that the inside of the protruding portion 16 is configured to be dense (that is, in a state to be filled with a material forming the main body 2). However, by configuring the protruding portion 16 as another bulging portion having a hollow interior, the protruding portion 16 can be manufactured in the same process as the bulging portion 10, and the weight of the item container 1 can be reduced. Therefore, the protruding portion 16 has nothing inside except gas (air, gas for sterilization, etc.).
The protruding portion 16 is provided to extend in an elongated manner in the x direction (third direction along the flange portion 19) different from the z direction (first direction) and the y direction (second direction). Note that, here, the x direction orthogonal to the y direction is given as a preferable example of the third direction in which the protruding portion 16 extends in an elongated manner, but the third direction is not limited thereto, and the third direction in which the protruding portion 16 extends in an elongated manner may be a direction different from the y direction along an xy plane.
As illustrated in
Furthermore, as illustrated in
The seal body 3 is bonded to the flange portion 19 so as to cover at least an opening of the bulging portion 10 (seal the opening while maintaining a sterile condition). Specifically, the seal body 3 of the present embodiment has a substantially rectangular shape having substantially the same side edge as the side edge of the flange portion 19 of the main body 2, and is configured to cover not only the opening of the bulging portion 10 but also an opening of the protruding portion 16 (another bulging portion).
As illustrated in a portion hatched from the upper right to the lower left in
Note that here, since it is assumed that the medical device storage pack 40 is held by the left hand and the seal body 3 is unsealed by the right hand, the tab portion 3c is provided in an upper right portion of
For example, the tab portion 3c may be provided in an upper left portion of
Alternatively, the tab portion 3c may be provided in both the upper right portion and the upper left portion in
As illustrated in
To be specific, an angle θ1 formed by the right side of the seal body 3 and a line segment p2p1 is, for example, 30°, an angle θ2 formed by the upper side of the seal body 3 and a line segment p3p1 is, for example, 30°, and the angle of the boundary of the bonding portion 3a at each of the apexes p1, p2, and p3 is, for example, 150°.
Note that in the example illustrated in
In addition, although the number of apexes at the boundary between the bonding portion 3a and the tab portion 3c is three here, the number may be four or more.
At least one of the main body 2 and the seal body 3 described above, and preferably both of them are made of a material having optical transparency (for example, clear or translucent) so that an item for a medical device stored inside can be visually checked.
Specifically, an example of the material constituting the main body 2 is a laminated resin in which polyethylene terephthalate (PET) and a PET-based resin are laminated. In addition, an example of a material constituting the seal body 3 is a laminated resin in which polyethylene (PE) and a PE-based resin are laminated.
By using a combination of these materials for the main body 2 and the seal body 3, the main body 2 and the seal body 3 can be bonded by thermal bonding or thermal welding, and a bonding step using an adhesive or the like is not required. Furthermore, by using a laminated resin for the main body 2 and the seal body 3, a sealing property (watertightness and airtightness) of the bonding portion can be maintained, and a sterilization property of the stored item can be favorably maintained.
However, the combination of the materials constituting the main body 2 and the seal body 3 is not limited to the above-described example, and appropriate materials may be used as long as the main body 2 and the seal body 3 can be bonded by thermal bonding or thermal welding and the sealing property and the sterilization property can be maintained. In the way described above, the seal body 3 is bonded to the flange portion 19 in a state where an item for a medical device is stored in the item container 1, completing the medical device storage pack 40 in which a periphery of the item for the medical device is sealed.
Meanwhile, the medical device storage pack 40 in which the item for the medical device is stored in the item container 1 becomes a sterilized pack by applying sterilization treatment. Such sterilization treatment includes radiation sterilization, gamma radiation sterilization, gas sterilization (e.g., ethylene oxide gas (EOG) sterilization), and the like.
When radiation sterilization or gamma radiation sterilization is performed as the sterilization treatment, the above-described laminated resin can be used as the material of the main body 2 and the seal body 3. Meanwhile, when gas sterilization is performed, it is necessary to form the seal body 3 by using a porous material such as sterile paper having air permeability. When the gas sterilization is performed, the seal body 3 made of, for example, sterile paper is bonded to the main body 2 using an adhesive or the like.
On the seal body 3 of the sterilized medical device storage pack 40, a traceability seal 21 for tracing the process of production and distribution is attached. On the traceability seal 21, for example, a two-dimensional bar code, a manufacturer name, and the like are written.
For example, as indicated by a portion 3b hatched from the upper left to the lower right in
Accordingly, it is possible to easily check whether or not the item for the medical device is reliably stored in the medical device storage pack 40 by, for example, a camera (or visual observation by a human) at the time of manufacturing. Further, the traceability seal 21 can be easily checked by a camera (or visual observation by a human) at the same time as checking of the stored item for the medical device.
Note that in the example of
Next,
In the present embodiment, the forceps plug 31 is stored in the bulging portion 11, the suction button 32 is stored in the bulging portion 12, and the air/water supply button 33 is stored in the bulging portion 13. The forceps plug 31, the suction button 32, and the air/water supply button 33 of the digestive system endoscope are examples of the items for the medical device, which are often sold together in one package.
Note that although the digestive system endoscope has been described here as an example of the medical device, the endoscope is not limited to the digestive system, and may be endoscopes in other fields. Furthermore, the item for the medical device is not limited to an item for an endoscope, but may be, for example, an item for a treatment instrument such as an energy treatment instrument, or an item for another device used for medical treatment.
When the medical device storage pack 40 is unsealed, the bulging portion 10 is held so as to be sandwiched between the thumb of one hand, the left hand in the example of
In the state above, the tab portion 3c is pinched by the fingers (for example, the thumb and the index finger) of the right hand and moved in a direction of an arrow A in
Accordingly, the force in the direction of the arrow A for unsealing the seal body 3 is not used for the positional deviation of the medical device storage pack 40 but is effectively used for peeling the bonding portion 3a.
Further, at the time of the peeling of the bonding portion 3a, since not only the apexes p2 and p3 on both sides but also the central apex p1 is further provided at the boundary between the bonding portion 3a and the tab portion 3c, for example, the peeling of the bonding portion 3a can be started from the apex p1 by only pulling the tab portion 3c naturally, without tilting and pulling the tab portion 3c so as to start the peeling of the bonding portion 3a from the apex p2 or the apex p3. In the way described above, it is possible to increase the probability that the peeling of the bonding portion 3a starts from any of the apexes p1, p2, and p3.
As a result, when the tab portion 3c is pinched and moved in the direction of the arrow A, the unsealing force in the direction of the arrow A first acts in a concentrated manner on any one of the apexes p1, p2, and p3 (for example, the apex p1), and the peeling of the bonding portion 3a can be easily started without requiring a large force.
As just described, once the peeling is started from any one of the apexes p1, p2, and p3 as a starting point, the peeling of the bonding portion 3a proceeds smoothly by continuing to apply an appropriate force thereafter.
At the time when the peeling of the bonding portion 3a reaches an unsealing position OP1 in
When the peeling of the bonding portion 3a reaches an unsealing position OP2 of
Subsequently, when the peeling of the bonding portion 3a reaches an unsealing position OP3 in
Thereafter, when the peeling of the bonding portion 3a reaches an unsealing position OP4 in
As illustrated in
Next,
Here, in
As illustrated in
The medical device storage packs 40 in the lower pack row 40B are stored in the box 50 in a state of being rotated by 180° around an axis in the X direction (that is, facing the opposite side in the Y direction) with respect to the medical device storage packs 40 in the upper pack row 40A.
In the storage state above, the upper pack row 40A and the lower pack row 40B are stored so as to partially overlap in positions in the Y direction. To be specific, the position in the Y direction on the side of the protruding portion 16 including the spherical concave portion 15 of the upper pack row 40A and the position in the Y direction on the side of the protruding portion 16 including the spherical concave portion 15 of the lower pack row 40B overlap each other.
In the portion where the positions in the Y direction overlap, as illustrated in
Similarly, as illustrated in
As a result, the plurality of medical device storage packs 40 is spread in the Z direction (+Z direction and −Z direction) as a whole and comes into contact with an inner wall of the box 50, thereby suppressing the movement (not only the movement in the Z direction but also the movement in the Y direction) in the box 50. Therefore, when the box 50 is transported, the medical device storage packs 40 can be prevented from rattling inside the box 50.
Note that in order to enable such a storing method, it is preferable that the total length of the thickness of the spherical concave portion 15 in the z direction and the thickness of the protruding portion 16 in the z direction be substantially the same as the thickness of the bulging portion 10 in the z direction.
In addition, the length of the box 50 in the Y direction is configured such that a space having a length SP (the length SP in the Y direction) is generated inside the box 50 after the medical device storage packs 40 are stored in two rows. By adopting such a configuration, the medical device storage pack 40 can be easily taken out from the box 50 by inserting a finger or the like into the space having the length SP.
In other words, while the number of medical device storage packs 40 stored in the box 50 is an even number in
As compared with the example of
Accordingly, a hand or a finger can be inserted into the space 50a, and the medical device storage pack 40 can be taken out more easily than the example of
Also in the storage method above, as in the storage method of
However, in the storage method of
Note that in the above-described embodiment, the plurality of items for the medical device is stored in the item container 1, but the present invention is not limited to the plurality of items, and one or more items for the medical device may be stored.
Although
Therefore, according to the first embodiment, since the protruding portion 16 is arranged at the position spaced apart from the bulging portion 10 in the second direction and the protruding portion 16 is provided so as to extend in an elongated manner in the third direction different from the second direction (and the first direction), the base of the thumb or a part of the palm of the hand holding the bulging portion 10 of the item container 1 enters between the bulging portion 10 and the protruding portion 16 and comes into contact with the protruding portion 16, thereby preventing rotation or positional displacement of the medical device storage pack 40 and making it possible to easily and reliably unseal the seal body 3.
Then, since the seal body 3 is smoothly unsealed, it is possible to prevent the item for the medical device stored in the bulging portion 10 from accidentally falling off when the medical device storage pack 40 is unsealed.
Further, by forming the protruding portion 16 as another bulging portion having a hollow interior, the protruding portion 16 can be manufactured in the same process as the bulging portion 10, and the weight of the item container 1 can be reduced.
Since the seal body 3 covers not only the opening of the bulging portion 10 but also the opening of the protruding portion 16, the area of the seal body 3 covering the part other than the bulging portion 10 is increased, and the traceability seal 21 can be attached without covering the stored item for the medical device.
In addition, by configuring the third direction to be orthogonal to the second direction, an outer shape of the item container 1 can be reduced while ensuring the distance between the bulging portion 10 and the protruding portion 16.
By configuring the bulging portion 10 to include the plurality of bulging portions 11, 12, and 13, a plurality of items for the medical device can be collectively stored. Thus, the item container 1 suitable for items to be sold as a set is obtained.
Since the second direction is configured to be orthogonal to the arrangement direction of at least the two bulging portions 11 and 12 among the plurality of bulging portions 11, 12, and 13, it is possible to take out the plurality of items for the medical device one by one in order when the tab portion 3c is moved in an oblique direction, as illustrated in
By making the length D2 of the protruding portion 16 in the first direction smaller than the length D1 of the bulging portion 10 in the first direction, when the medical device storage packs 40 are stored in, for example, two rows in the box, the portions of the upper pack row 40A and the lower pack row 40B other than the bulging portion 10 can be overlapped each other, so that the storage property can be enhanced and the movement of the medical device storage packs 40 in the box 50 can be suppressed.
By configuring the length W2 of the protruding portion 16 in the third direction to be larger than the length W1 of the bulging portion 10 in the third direction, the base of the thumb or a part of the palm of the hand holding the bulging portion 10 can reliably enter between the bulging portion 10 and the protruding portion 16. As a result, the medical device storage pack 40 can be more reliably held at the time of unsealing.
It should be noted that the present invention is not limited to the above-described embodiment as it is, and can be embodied by modifying constituent elements without departing from the gist of the present invention at an implementation stage. In addition, various aspects of the invention can be formed by appropriately combining the plurality of constituent elements disclosed in the above embodiment. For example, some constituent elements may be deleted from all the constituent elements shown in the embodiment. Furthermore, constituent elements in different embodiments may be appropriately combined. As described above, it goes without saying that various modifications and applications can be made without departing from the gist of the invention.
This application is a continuation application of PCT/JP2020/029988 filed on Aug. 5, 2020, the entire contents of which are incorporated herein by this reference.
Number | Date | Country | |
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Parent | PCT/JP2020/029988 | Aug 2020 | US |
Child | 18101192 | US |