WO2023166678A1

WO2023166678A1 - Packaging container for medical device

Info

Publication number: WO2023166678A1
Application number: PCT/JP2022/009202
Authority: WO
Inventors: 蓮見清章
Original assignee: テルモ株式会社
Priority date: 2022-03-03
Filing date: 2022-03-03
Publication date: 2023-09-07

Abstract

Provided is a packaging container for a medical device, the packaging container having exceptional performance in protecting a medical device. This packaging container (10) for a medical device comprises a container body (16) having a recessed section (14) for accommodating a medical device. An impact-mitigating protrusion (42) is provided to a bottom part (36e) of the recessed section (14), the impact-mitigating protrusion (42) contacting the medical device to thereby separate the medical device from the bottom part (36e) of the recessed section (14). The impact-mitigating protrusion (42) supports the medical device through linear contact with the medical device.

Description

medical device packaging

The present invention relates to a packaging container for medical devices that stores medical devices in recesses of a resin sheet.

A packaging container for medical devices is known, which stores medical devices in recesses formed in a resin sheet. Such packaging containers are also called blister packages, blister cases, etc., and are used, for example, for packaging medical devices such as drug solution administration devices that are applied to the body and prefilled syringes.

Japanese Patent Application Laid-Open No. 2011-005182 relates to a packaging container for a prefilled syringe, in which a part of the bottom of the recess is protruded deeper to form a gap between the prefilled syringe and the bottom to form a medical device. Protecting structures are described.

However, the packaging container disclosed in Japanese Patent Application Laid-Open No. 2011-005182 has a structure in which the flat part of the bottom of the recess abuts the prefilled syringe. Therefore, when the packaging container is dropped, if an obstacle at the drop location happens to hit the flat portion that abuts the prefilled syringe, there is a risk that the impact will be transmitted to the prefilled syringe without being relieved.

In the case of a medical device that contains precision parts such as a circuit board and a drive mechanism such as gears, such as a drug administration device, there is a risk that the medical device will be damaged even by the impact input from the flat part. Therefore, packaging containers for medical devices containing precision parts are required to have higher protection performance.

One aspect of the disclosure below includes a container body having a recess for housing a medical device, the recess having a bottom and a shock absorbing projection projecting inward from the bottom, The shock absorbing protrusion is in a packaging container for a medical device, which is in contact with the medical device to separate the medical device from the bottom portion of the recess and supports the medical device by making line contact with the medical device. .

According to the medical device packaging container of the above-described viewpoint, the shock absorbing convex portion supports the medical device in line contact. As a result, the contact area between the medical device and the packaging container becomes smaller, and the area of the fragile portion where the shock from hitting an obstacle at the drop point may be transmitted directly to the medical device is reduced, so precision parts can be used. Excellent protection performance for medical equipment with built-in

1 is an exploded perspective view of a packaging container for a medical device according to an embodiment; FIG. FIG. 2 is a plan view of the container body of FIG. 1; FIG. 3 is a cross-sectional view taken along line III-III of FIG. 2; FIG. 2 is a plan view of a state in which the drug-solution administration device is accommodated in the container body of FIG. 1; In addition, in FIG. 4, illustration of the housing|casing adhesive material and a protective sheet of a chemical|medical-solution administration apparatus is abbreviate|omitted. FIG. 5 is a cross-sectional view taken along line VV of FIG. 4;

Hereinafter, preferred embodiments of the present invention will be cited and described in detail with reference to the accompanying drawings.

As shown in FIG. 1, a medical device packaging container 10 (hereinafter referred to as packaging container 10) according to the present embodiment accommodates a small patch-type drug-solution administration device 12 (medical device) to be applied to a patient's body. used for The packaging container 10 includes a container body 16 in which a recess 14 capable of accommodating the drug solution administration device 12 is formed in a transparent resin sheet, and the drug solution administration device 12 that is adhered to the container body 16 and accommodated in the recess 14 is sealed. and a sealing film 18 .

The drug-solution administration device 12 has a box-shaped housing 20 . Inside the housing 20, although not shown, there are a cylindrical body containing the chemical solution, a pusher for sending out the chemical solution, a drive mechanism for driving the pusher, a circuit board for controlling the drive mechanism, a battery, and the like. is provided. The drug solution administration device 12 is used to continuously or intermittently administer a drug solution into the body over a relatively long period of time (for example, several minutes to several hours).

The housing 20 is formed in a flat rectangular parallelepiped shape having a rectangular front surface 20a, a rear surface 20b and four side surfaces 20c to 20f. A side surface 20c of the housing 20 is provided with a connection port 22 for connecting, for example, a patch-type tube with a needle, a transfer line tube, or the like. The connection port 22 is formed in a cylindrical shape and protrudes short in a direction perpendicular to the side surface 20c.

A power switch 25 is provided on the rear surface 20b of the housing 20 to start driving the drug solution administration device 12. The back surface 20b is a surface for attaching the housing 20 to the patient's body, and after the power switch 25 is operated, the back surface 20b is attached to the patient's skin.

A housing sticking material 24 for sticking the housing 20 to the patient's skin is attached to the rear surface 20b of the housing 20. The housing attachment material 24 is made of, for example, a double-sided adhesive sheet. One surface of the housing adhesive material 24 is bonded to the back surface 20b, and the other surface is an adhesive surface to be attached to the patient's skin. The adhesive surface is covered with a protective sheet 28 for protection.

On the other hand, as shown in FIG. 2, the container main body 16 is formed in a rectangular shape in plan view, and the sticking portion 32 is formed in a rectangular frame shape along the outer peripheral portion. Further, inside the sticking portion 32 of the container main body 16, a concave portion 14 for accommodating the drug solution administration device 12 is provided. An intermediate portion 34 having a flat surface is formed between the concave portion 14 and the sticking portion 32 .

The concave portion 14 has a housing accommodating portion 36 that accommodates the housing 20 of the drug-solution administration device 12 and a port accommodating portion 38 that accommodates the connection port 22 . The housing housing portion 36 is formed in a portion surrounded by four

side wall portions

36a, 36b, 36c, 36d and a bottom portion 36e, and is formed in a rectangular shape in plan view. The side wall portion 36 a and the side wall portion 36 b extend in the long side direction of the container body 16 . The side wall portion 36 c and the side wall portion 36 d extend in the width direction of the container body 16 . The

side wall portions

36a and 36b in the long side direction are longer than the

side wall portions

36c and 36d in the width direction.

As shown in FIG. 1 , the side wall portion 36 a faces the side surface 20 d of the housing 20 , and the side wall portion 36 b faces the side surface 20 e of the housing 20 . Moreover, the side wall portion 36 c faces the side surface 20 c of the housing 20 , and the side wall portion 36 d faces the side surface 20 f of the housing 20 . Lower ends of the side walls 36a to 36d are connected to the bottom 36e. The bottom portion 36 e faces the front surface 20 a of the housing 20 .

A bottom portion 36 e of the housing housing portion 36 is formed larger than the front surface 20 a and the rear surface 20 b of the housing 20 . Further, the depth of the housing accommodating portion 36 (the depth from the intermediate portion 34 to the bottom portion 36e) is formed larger than the thickness of the housing 20 (the thickness from the front surface 20a to the rear surface 20b). The entire housing 20 is housed in the housing housing portion 36 .

A plurality of side wall protrusions 40a to 40d are provided on the side wall portions 36a to 36d of the housing accommodating portion 36. As shown in FIG. Further, a plurality of shock absorbing projections 42 are provided on the bottom portion 36e. The side wall protrusions 40a to 40d and the shock absorbing protrusions 42 are formed by swelling the resin sheets forming the side wall portions 36a to 36d and the bottom portion 36e of the housing housing portion 36 toward the inside of the housing housing portion 36. It extends like a rib in a predetermined direction.

The side wall portion 36a is provided with two side wall projections 40a at a portion near the side wall portion 36c and a portion near the side wall portion 36d. Further, the side wall portion 36b is provided with two side wall protrusions 40b. The two side wall protrusions 40a and the two side wall protrusions 40b are provided to face each other in the width direction. The side wall portion 36c is provided with one side wall protrusion 40c, and the side wall portion 36d is provided with two side wall protrusions 40d.

As shown in FIG. 1, each of the side wall projections 40a to 40d is formed extending in the depth direction (vertical direction) of the housing housing portion 36. As shown in FIG. The side wall protrusions 40 a to 40 d are formed in a semicircular cross section, and the ridgeline portions L thereof come into contact (line contact) with the housing 20 .

As shown in FIG. 2, the distance D1 between the side wall protrusion 40a of the side wall portion 36a and the side wall protrusion 40b of the side wall portion 36b is slightly smaller than the dimension of the housing 20 in the width direction. Further, a distance D2 along the long side direction between the side wall protrusion 40c of the side wall portion 36c and the side wall protrusion 40d of the side wall portion 36d is smaller than the dimension of the housing 20 in the long side direction. Therefore, the housing 20 is held in a state of being sandwiched by the side wall protrusions 40a to 40d within the housing accommodating portion 36. As shown in FIG.

Four shock absorbing projections 42 are formed on the bottom 36e. The shock absorbing protrusions 42 are provided in a rib-like manner extending from the lower ends of the

side wall protrusions

40a and 40b toward the center in the width direction. The shock absorbing convex portion 42 is divided at a dividing portion 44 near the center in the width direction.

As shown in FIG. 3, each of the shock absorbing protrusions 42 has a semicircular cross-sectional shape. The shock absorbing convex portion 42 has a curved surface with a curved upper end, and is configured to make line contact with the front surface 20a of the housing 20 at the ridge portion L thereof. Each shock absorbing projection 42 is integrally formed with the adjacent sidewall projection 40a or sidewall projection 40b.

The width W (the dimension in the direction perpendicular to the extending direction) of the side wall protrusions 40a to 40d and the shock absorbing protrusions 42 can be, for example, about 3 to 10 mm. If the width W is smaller than the above lower limit, the resin sheet forming the container body 16 cannot be sufficiently deformed when an impact load is applied, and the impact load mitigation performance is reduced. Further, when the width W is larger than the above upper limit value, the possibility that the obstacle at the collision site enters the side wall projections 40a to 40d and the shock absorbing projection 42 and the impact is directly input to the housing 20 increases. .

The cross-sectional shape of the side wall protrusions 40a to 40d and the shock absorbing protrusions 42 is not limited to a semicircular shape, and various curved shapes or polygonal shapes may be used to form a narrow linear region that is in line contact with the housing 20 or nearly so. You may make it contact|abut.

Between the housing 20 and the side wall portions 36a to 36d, gaps are formed corresponding to the protrusion heights of the side wall convex portions 40a to 40d. When the user removes the housing 20 from the container body 16, the projection height of the side wall protrusions 40a to 40d is adjusted to prevent the user from touching the fragile portion of the drug-solution administration device 12. It is preferable to set the height to such an extent that it does not enter. Therefore, the protrusion height of the side wall protrusions 40a to 40d can be, for example, approximately 1 to 5 mm. If the protrusion height of the side wall protrusions 40a to 40d is smaller than the above lower limit, the gap between the side wall portions 36a to 36d and the housing 20 becomes too narrow, and the chemical liquid administration device 12 is affected by the impact input from the side. protection performance is reduced. Also, if the projection height of the side wall projections 40a to 40d is greater than the above upper limit, there is a possibility that the user's finger may get inside.

Also, a gap is formed between the housing 20 and the bottom portion 36e according to the projection height of the shock absorbing convex portion 42. The protrusion height of the shock absorbing protrusions 42 is preferably 1 mm or more, for example. If the projecting height of the shock absorbing projections 42 is less than the above value, a sufficient deformation range of the shock absorbing projections 42 cannot be ensured, and the protection performance of the medical solution administration device 12 against the input of shocks deteriorates.

Side wall portions

36a and 36b of housing housing portion 36 are formed with recessed portions 46 for grasping so that the user can easily grasp housing 20 when taking drug solution administration device 12 out of container main body 16. there is The gripping concave portion 46 forms a gap between the housing accommodating portion 36 and the housing 20 into which the user can insert his/her fingertip. The grasping concave portion 46 is provided in a portion avoiding a fragile portion of the medical-solution administration device 12 .

A port accommodating portion 38 is formed in the side wall portion 36 c of the housing accommodating portion 36 . The port accommodating portion 38 is formed in a portion of the concave portion 14 where the connection port 22 is arranged. The port accommodating portion 38 is formed in a shape larger than the connection port 22 . Therefore, the connection port 22 is accommodated in the port accommodating portion 38 while being separated from the inner peripheral surface of the port accommodating portion 38 . In order to prevent the user from touching the connection port 22 and inputting a bending load to the connection port 22 when taking out the drug-solution administration device 12 from the container main body 16, the gap between the port accommodating portion 38 and the connection port 22 is It is formed in a size that does not allow the user's fingertip to enter.

An intermediate portion 34 is formed around the recess 14 . The intermediate portion 34 is a flat portion formed between the concave portion 14 and the rectangular adhered portion 32 . The intermediate portion 34 is connected to the sticking portion 32 via a stepped portion 34a, and is formed at a position lower than the sticking portion 32 (close to the bottom portion 36e of the concave portion 14). The intermediate portion 34 forms a gap between the medical-solution administration device 12 accommodated in the recess 14 and the sealing film 18 to form a space for protecting the medical-solution administration device 12 . In addition, the intermediate portion 34 accommodates the casing attachment material 24 of the drug-solution administration device 12 and its protective sheet 28 .

As shown in FIG. 2, the sticking portion 32 is formed in a rectangular shape along the outer periphery of the container body 16. As shown in FIG. The width of the sticking portion 32 is formed substantially constant over the entire circumference. The upper end of the sticking portion 32 is configured as a flat surface so that the sealing film 18 can be adhered thereto. A spaced portion 33 is formed at one end of the sticking portion 32 . As shown in FIG. 3, the spacing portion 33 is formed lower than the other portion of the sticking portion 32 through the stepped portion 33a. The spacing portion 33 is spaced apart from the sealing film 18 (FIG. 1) due to static electricity, moisture, etc., and is kept in a state of being spaced apart from the sealing film 18 . The gap between the spaced portion 33 and the sealing film 18 forms a grip margin that the user can easily grip when peeling off the sealing film 18 .

The container body 16 is made of, for example, a transparent resin sheet such as PET resin. It is preferable that the thickness of the resin sheet of the container body 16 is relatively thick, for example, about 0.8 mm. If the thickness of the resin sheet is too thin, the strength of the container body 16 will be insufficient, and it will not be possible to protect the drug solution administration device 12 from the impact of dropping. On the other hand, if the thickness of the resin sheet is too thick, the strength and rigidity of the side wall projections 40a to 40d and the shock absorbing projections 42 become too high, making it difficult to absorb the impact when dropped.

As shown in FIG. 1, the sealing film 18 is formed in a rectangular shape with substantially the same dimensions as the container body 16. The sealing film 18 is made of a thin flexible film made of polyethylene resin, for example. The sealing film 18 is adhered to the sticking portion 32 so as to cover the concave portion 14 and the intermediate portion 34 from the upper side of the container body 16 , thereby sealing the drug-solution administration device 12 . The sealing film 18 is adhered releasably by sandwiching the adhered portion with a mold while being superimposed on the adhered portion 32 and locally heating and fusing.

The packaging container 10 of the present embodiment is configured as described above, and its operation will be described below.

As shown in FIG. 1, the container body 16 of the packaging container 10 accommodates the drug solution administration device 12 in the concave portion 14 thereof. The drug-solution administration device 12 is housed in a state in which the front surface 20a of the housing 20 faces downward and the rear surface 20b on which the housing adhesive material 24 is provided faces upward.

As shown in FIG. 4, side wall projections 40a to 40d of the recess 14 abut against four side surfaces 20c to 20f of the housing 20 of the drug solution administration device 12. As shown in FIG. Ridge portions L of the side wall projections 40a to 40d and the housing 20 are supported in a state of line contact, and are kept floating from the side wall portions 36a to 36d. Further, when the housing 20 is inserted into the housing housing portion 36, the side wall projections 40a to 40d are slightly elastically deformed, and the housing 20 is moved by the elastic force of the side wall projections 40a to 40d. It is sandwiched within portion 36 .

Further, as shown in FIG. 5 , the front surface 20 a of the housing 20 abuts on the shock absorbing projection 42 protruding from the bottom 36 e of the housing housing portion 36 . The housing 20 is in line contact with the ridge line portion L of the shock absorbing convex portion 42 and is supported in a state of floating from the bottom portion 36e.

When the packaging container 10 containing the drug solution administration device 12 is dropped, the impact from the bottom 36e side is mitigated by the elastic deformation of the impact-mitigating projections 42. Moreover, the impact from the side wall portions 36a to 36d is relieved by the elastic deformation of the side wall protrusions 40a to 40d.

In the packaging container 10, the portion where the container body 16 is in direct contact with the housing 20 is fragile, and when an obstacle at the drop point collides, the impact is transmitted directly to the drug solution administration device 12 without being mitigated. part of it. In the packaging container 10 of the present embodiment, the fragile portions are limited to line contact portions with the housing 20 along the ridgeline portions L of the side wall projections 40a to 40d and the shock absorbing projections . Therefore, it is possible to reduce the possibility that a direct impact is transmitted to the housing 20, and it is excellent in the protection performance of the medical equipment.

The packaging container 10 for medical devices of this embodiment has the following effects.

The medical device packaging container 10 of the present embodiment includes a container body 16 having a recess 14 for accommodating the medical device (medical solution administration device 12). The shock absorbing convex portion 42 protrudes toward the medical device, and the shock absorbing convex portion 42 makes contact with the medical device to separate the medical device from the bottom portion 36e of the recess 14, and makes line contact with the medical device to remove the medical device. To support.

According to the above configuration, the fragile portion where the impact may be transmitted directly to the medical device without being relieved is limited to the portion where the medical device and the container body 16 are in line contact, so the medical device can be protected. Excellent performance.

In the packaging container 10 for the medical device described above, the shock absorbing convex portion 42 may be formed of a curved surface convexly curved in the projecting direction of the shock absorbing convex portion 42 . According to this configuration, the ridge line portion L of the curved surface of the shock absorbing convex portion 42 is in line contact with the medical device, thereby providing excellent protection performance for the medical device. In addition, the curved surface of the shock absorbing convex portion 42 is elastically deformed and flexed, thereby providing excellent shock absorbing performance.

In the medical device packaging container 10 described above, the medical device is a drug solution administration device 12 having a box-shaped housing 20 and a connection port 22 protruding from a side surface 20c of the housing 20. A housing accommodating portion 36 that accommodates the entire body 20 and a port accommodating portion 38 that accommodates the connection port 22 may be provided, and the shock absorbing convex portion 42 may be provided in the housing accommodating portion 36 . According to this configuration, the mitigated impact load can be transferred to the side of the housing 20 having relatively high strength, and damage to the connection port 22 of the drug-solution administration device 12 can be prevented.

In the medical device packaging container 10 described above, the shock absorbing protrusions 42 may extend in the width direction from both sides of the housing housing portion 36, and may be provided with a dividing portion 44 in the center portion in the width direction. . In this configuration, two shock absorbing protrusions 42 are provided separately in the width direction. According to this configuration, it is possible to further reduce the contact area between the shock absorbing protrusions 42 and the housing 20 . This further shortens the contact portion where an impact may be directly input to the housing 20, thereby providing excellent protection performance for the medical device (medical solution administration device 12).

In the medical device packaging container 10 described above, the side wall portions 36a to 36d of the housing housing portion 36 protrude toward the housing 20 in a rib-like shape, and contact with the side surfaces 20c to 20f of the housing 20. A plurality of side wall projections 40a to 40d are provided to separate the side wall portions 36a to 36d of the housing housing portion 36, and the housing 20 is sandwiched between the plurality of side wall projections 40a to 40d, so that the housing housing portion 36 may be held within With this configuration, it is possible to protect the medical device (medical solution administration device 12) even from collisions with obstacles against the side walls 36a to 36d.

In the medical device packaging container 10 described above, the side wall protrusions 40 a to 40 d may be configured to be in line contact with the housing 20 . According to this configuration, it is possible to limit the contact portion where the impact from the obstacle may be input without being relieved. Excellent protection performance.

In the medical device packaging container 10 described above, the

side wall projections

40a and 40b and the shock absorbing projection 42 may be integrally connected. According to this configuration, the rigidity can be increased compared to when the

side wall projections

40a and 40b and the shock absorbing projection 42 are provided separately, and deformation of the recess 14 due to impact can be suppressed.

In the medical device packaging container 10 described above, the side wall protrusions 40a to 40d are close to the housing 20 and the housing housing portion 36 so that the fingertips do not enter the gap between the housing 20 and the housing housing portion 36. 36 may be spaced apart. According to this configuration, the user can be prevented from touching a careless part of the medical device when taking out the medical device from the packaging container 10 .

In the medical device packaging container 10 described above, the housing accommodating portion 36 may be provided with a grasping concave portion 46 that bulges outward to form a gap between the housing 20 and the housing 20 into which a fingertip can be inserted. good. This configuration allows the user to grasp the appropriate portion of the medical device to remove it from the packaging container 10 .

In the medical device packaging container 10 described above, the connection port 22 is accommodated in a state separated from the port accommodation portion 38, and the port accommodation portion is positioned so that a fingertip does not enter the gap between the connection port 22 and the port accommodation portion 38. 38 may be approached. This configuration can prevent the user from touching the connection port 22 .

Although the preferred embodiments of the present invention have been described above, the present invention is not limited to the above embodiments, and it goes without saying that various modifications can be made without departing from the scope of the present invention. stomach.

DESCRIPTION OF SYMBOLS 10... Packaging container 12... Chemical-solution administration apparatus 14... Recessed part 16... Container main body 20... Case 22... Connection port 36... Case accommodating part 36e... Bottom part 38... Port accommodating part 40a-40d... Side wall convex part 42... Impact mitigation convex part Part 44... Division part

Claims

Equipped with a container body having a recess for accommodating the medical device,
The recess has a bottom and a shock absorbing projection projecting inward from the bottom,
The shock absorbing protrusions contact the medical device to separate the medical device from the bottom portion of the recess, and support the medical device by making line contact with the medical device.
Packaging containers for medical devices.
2. The packaging container for a medical device according to claim 1, wherein said shock absorbing convex portion is formed of a curved surface convexly curved in a projecting direction of said shock absorbing convex portion.
Packaging containers for medical devices.
3. The packaging container for a medical device according to claim 1 or 2, wherein the medical device is a drug solution administration device having a box-shaped housing and a connection port projecting from a side surface of the housing,
The recess includes a housing housing section that houses the entire housing, a port housing section that houses the connection port,
has
The shock absorbing convex portion is provided in the housing accommodating portion,
Packaging containers for medical devices.
4. The packaging container for medical devices according to claim 3, wherein the shock absorbing convex portion extends in the width direction from both side portions of the housing accommodating portion, and a dividing portion is provided in the center portion in the width direction. ing,
Packaging containers for medical devices.
A packaging container for a medical device according to claim 3 or 4,
a plurality of side walls protruding from a side wall portion of the housing accommodating portion toward the housing in a rib shape and abutting against a side surface of the housing to separate the housing from the side wall portion of the housing housing portion; A convex portion is provided, and the housing is held in the housing accommodating portion by being sandwiched between the plurality of side wall convex portions.
Packaging containers for medical devices.
6. The packaging container for medical devices according to claim 5, wherein the side wall protrusion is in line contact with the housing.
Packaging containers for medical devices.
7. The packaging container for medical devices according to claim 6, wherein the side wall convex portion and the shock absorbing convex portion are integrally connected.
Packaging containers for medical devices.
A packaging container for a medical device according to any one of claims 5 to 7,
the side wall convex part separates the housing and the housing housing part in a state in which the fingertips do not enter the gap between the housing and the housing housing part;
Packaging containers for medical devices.
A packaging container for a medical device according to claim 8,
The housing housing portion is provided with a grip recess that bulges outward and forms a gap between the housing and the housing into which a fingertip can be inserted.
Packaging containers for medical devices.
A packaging container for a medical device according to any one of claims 3 to 9,
The connection port is accommodated in a spaced apart state from the port accommodation portion, and is so close to the port accommodation portion that a fingertip does not enter a gap between the connection port and the port accommodation portion.
Packaging containers for medical devices.