JP7580764B2 - Manufacturing method for medical equipment container - Google Patents

Description

The present invention relates to a method for manufacturing a medical equipment container capable of transporting medical equipment housed therein in a fixed state.

2. Description of the Related Art A container is known in which, for transporting medical equipment, the medical equipment is housed within a container body and the opening of the container body is wrapped with a gas-impermeable film or a film such as Tyvek (registered trademark) made by DuPont that is made of high-density polyethylene nonwoven fabric and that allows gas to pass through but not bacteria (hereinafter sometimes referred to as "Tyvek, etc.").
For example, WO2013/125443A1 (Patent Document 1) proposes a container in which a medical device is accommodated in a container body and wrapped in Tyvek or the like at the opening of the container body.

However, this type of packaging using only Tyvek etc. means that the medical devices inside cannot be secured in place during transport, and there is a risk that the holders that hold the medical devices may move, resulting in a decrease in the cleanliness of the medical devices or that the medical devices may fall out of the holders. In addition, there was concern that the automatic device remover at the delivery destination may stop working due to the medical devices being misaligned.

WO2013/125443A1

To prevent such problems from occurring, when the opening of the container body is wrapped with Tyvek or similar, the medical equipment is secured in place by vacuum packaging (hereinafter sometimes referred to as "vacuum bag packaging"), in which the entire medical equipment container is placed in a bag-like material and a vacuum is applied to secure the medical equipment in place.

However, because the internal pressure of the vacuum bag packaging changes depending on how the worker sets it in the vacuum sealing machine, it is difficult to control the internal pressure of the vacuum bag packaging at a constant level, resulting in problems of variation. In addition, medical device containers are shipped to pharmaceutical companies, medical institutions, etc., but in order to use the medical device at the destination, it is generally necessary to remove the vacuum bag packaging in a sterile atmosphere and then remove the lid sealed to the opening of the container, which is very time-consuming. In particular, when filling medicines and other products in a filling machine, the filling is done using an automated process, so it was not easy to remove the vacuum bag packaging during such a process.

Therefore, an object of the present invention is to provide a method for manufacturing a medical device container that can fix and transport the medical device without vacuum bag packaging, and further to provide a method for manufacturing a medical device container that can easily remove packaging even in an automated process in a drug solution filling machine.

The inventors conducted extensive research to solve the above problems. As a result, they have completed the following invention.

(1) A method for manufacturing a medical device container in which a plurality of holders capable of holding a plurality of medical devices can be stacked and housed inside a container body having an opening at the top, the opening being sealed with a gas-impermeable film,
Each of the plurality of holders is configured to include a plate-shaped base portion and a support pillar protruding from the base portion,
the support pillars are configured to have a length such that, when the plurality of holders are stacked in the container body while holding the medical devices, the medical devices are not brought into contact with a bottom surface of the container body or with a holder adjacent to the holder holding the medical devices;
With the gas impermeable film initially in a slackened downward state, the sealing is performed in a space reduced in pressure to 400 hectopascals (hPa) or more and less than 1013 hectopascals (hPa), thereby maintaining the internal pressure of the medical device container after the sealing at the reduced pressure value in the space where the sealing was performed;
The gas-impermeable film is brought into contact with the holder or with both the holder and the medical device held by the holder ;
A method for manufacturing a medical equipment container, characterized in that the ratio (M1/M2) of the opening area M1 of the container body before decompression to the area M2 of the gas-impermeable film sealed to the opening before decompression is 0.70≦M1/M2≦0.90 .
(2) A method for manufacturing a medical equipment container as described in (1), characterized in that the ratio (α/L) of the longitudinal length L of the base plate portion of the holder to the maximum displacement α of the base plate portion of the holder in a direction perpendicular to the bottom surface of the container body is 0 < α/L ≦ 0.15.
( 3 ) Each of the plurality of holders is configured to have a plurality of cylindrical portions protruding from the base portion,
The manufacturing method of a medical equipment container described in (1) or (2) is characterized in that each of the multiple cylindrical portions is configured to have multiple locking protrusions around its periphery that hold the medical equipment in contact with the cylindrical portion.
( 4 ) The method for manufacturing a medical equipment container described in any one of (1) to ( 3 ), characterized in that the medical equipment is a cap to be placed on a stopper attached to the mouth of a pharmaceutical container.

The medical equipment container manufactured by the manufacturing method of the present invention allows the medical equipment contained therein to be fixed and transported without the need for vacuum bag packaging. Furthermore, the packaging can be easily removed in an automated process in a drug solution filling machine. The medical equipment container manufacturing method of the present invention makes it possible to manufacture a medical equipment container with such advantageous effects.

FIG. 1 is a perspective view of a medical equipment container according to an embodiment of the present invention. 2A is a plan view of the medical equipment container shown in FIG. 1, and FIG. 2B is a cross-sectional view taken along the line AA of FIG. FIG. 2 is a perspective view of the medical equipment container body shown in FIG. 1 . 2A is a perspective view of a holder to be installed in the medical equipment container shown in FIG. 1, and FIG. 2B is a plan view of the holder shown in FIG. 4A is an enlarged perspective view of the holder shown in FIGS. 4A and 4B, FIG. 4B is an enlarged front view of the holder shown in FIG. 4A, and FIG. 4C is a front view of a cap (medical device) held by the holder. 1. FIG. 4 is a perspective view of another example of a holder that is fitted inside the medical equipment container shown in FIG. 7A is a partial enlarged view of the holder shown in FIG. 6, and FIG. 7B is an enlarged cross-sectional view of a state in which a vial is held in the holder shown in FIG. 1A to 1C are longitudinal side views of a substrate, illustrating deformation caused by reduced pressure before and after the deformation. 1A is a perspective view of a gas-impermeable film in a state where the central portion is loosened, and FIG. 1B is a cross-sectional view taken along the line B-B of FIG.

[Embodiment]
An embodiment of the present invention will be described below with reference to FIGS.
Fig. 1 is a perspective view of a medical equipment container 1 according to one embodiment of the present invention, Fig. 2(A) is a plan view of the medical equipment container 1 shown in Fig. 1, and (B) is a cross-sectional view taken along the line A-A of (A). As shown in Fig. 1 and Fig. 2(A) and (B), the medical equipment container 1 according to this embodiment comprises a container body 2 with an opening at the top, a medical equipment holder 4 installed in the container body 2, and a gas-impermeable film 3 that seals the opening at the top of the container body 2, and the internal space of the medical equipment container 1 is configured to be in a reduced pressure state below atmospheric pressure.

As shown in FIG. 3, the container body 2 is box-shaped (basket-shaped) with a roughly rectangular planar shape, and includes an annular flange portion 22 formed to be annular and extend outward at the top opening, and a pair of step portions 23 provided in the longitudinal direction of the container body 2 at a position a certain length toward the bottom surface side from the annular flange portion 22. The step portions may be annular. The planar shape of the container body 2 may be a roughly rectangular shape as shown in the figure, or may be a polygonal, circular, or elliptical shape. Furthermore, the container body 2 is formed of synthetic resin, metal, or a mixture of these.

The medical device holder 4 to be fitted inside the container body 2 is placed inside the container body 2 either individually or in a stacked state as shown in FIG. 2(B). As shown in FIGS. 4(A)(B) and 5(A)(B), the medical device holder 4 to be fitted inside the container body 2 comprises a plate-shaped base plate 41 and a number of tubular parts 42 protruding downward from the base plate 41. A plate-shaped stay 49 is provided extending from the outside of each tubular part 42 to the outside of an adjacent tubular part 42. In addition, an annular flange part 421 is provided at the base end (substrate 41 side) of each tubular part 42, extending in the radial direction of the inside of the tubular part 42.

5(A) and 5(B), a locking protrusion 50 is provided around the tubular portion 42, protruding downward. The locking protrusion 50 is composed of a columnar leg 502 and a locking claw 501 protruding toward the tubular portion 42. In this example, three locking protrusions 50 are provided around each tubular portion 42, but this is not limited, and two or four or more may be provided. A substantially rectangular through hole 51 is provided between the base end of the locking protrusion 50 and the tubular portion 42. The shape of the through hole 51 is not limited, and may be a triangle, an ellipse, a circle, a polygon, or the like. The position of the through hole 51 is not limited to between the base end of the locking protrusion 50 and the tubular portion 42, and may be in the vicinity of the tubular portion 42. The provision of the through hole 51 allows the sterilized fluid to be distributed well within the container.

4(A), the holder 4 has support posts 45 at the periphery and center that protrude downward from the base portion 41. The support posts 45 are longer than the cylindrical portion 42 and the locking projections 50, so that the locking projections 50 and the medical device (cap 62) stored in the cylindrical portion 42 do not come into contact with the bottom surface of the container body 2. In addition, when the holders 4 are stacked, the locking projections 50 and the medical device (cap 62) stored in the cylindrical portion 42 do not come into contact with adjacent holders 4.
To stack the holders 4, the lower ends (tip ends) of the supports 45 are inserted into the connecting holes 47 (on the upper surface side of the base plate portion 41) at the base ends of the supports 45 of the holders 4 that are already placed. By repeating this process in sequence, the holders 4 can be stacked as shown in FIG. 2B.

5(A) to 5(C) will be used to explain the manner in which a cap 62 is placed over a rubber stopper (not shown) in order to prevent the rubber stopper from coming off when attached to seal the mouth of a pharmaceutical container or the like as an example of a medical device. The cap 62 is composed of a top surface 621 and a skirt 622 that protrudes cylindrically from the top surface 621. When the cap 62 is moved so that the top surface 621 faces the tubular portion 42, the outer edge of the top surface 621 comes into contact with the locking claw 501 of the locking projection 50. When the cap 62 is further pressed in, the locking projection 50 is elastically deformed, and the top surface 621 passes through and comes into contact with the tubular portion 42. When the locking projection 50 elastically returns to its original state, the locking claw 501 comes into contact with the top surface 621, and the cap 62 is held in the holder 4. The holder 4 is also suitable for holding a rubber stopper (not shown) that seals the mouth of a pharmaceutical container or the like. Additionally, it is suitable for holding a cap 62 that incorporates a rubber plug.
The holder 4 holds the cap 62, but the holder 4 may have various shapes depending on the medical device to be held, such as a piston, a barrel, or a vial. The gas-impermeable film 3, which will be described later, abuts against the substrate 41 for the holder 4 that holds the cap 62 or a piston (not shown), but abuts against the medical device such as a barrel or a vial, rather than against the substrate 41, in the case of the holder 4 that holds a barrel or a vial. Depending on the holder 4, there are also cases where the gas-impermeable film 3 abuts against both the substrate 41 and the medical device.

Next, the holder 4' for holding the vial 63 will be described. As shown in FIG. 6 and FIG. 7(A)(B), an annular convex portion 48 is provided on the inner surface of the lower end of the cylindrical portion 42'. A plurality of plate-shaped pads 423 having a substantially rectangular cross section are arranged on the inner surface of the cylindrical portion 42'. In FIG. 7(A)(B), four are arranged at equal intervals, but this is not limited to this, and there may be two or more, and they may not be evenly spaced. In addition, the shape may be a rectangle in cross section, a circle, an ellipse, a polygon, etc. Furthermore, it is not limited to a plate shape, and it may have a thickness such as a dome shape. A plurality of air holes 424 are provided in the cylindrical portion 42'. The shape of the air hole 424 may be a substantially rectangular shape as shown in the figure, a circle, an ellipse, a polygon, etc., but it is preferable that the hole is connected to the base portion 41'. This is to ensure that the sterilized fluid, etc., is well distributed. The other configuration is the same as that of the holder 4. Furthermore, by configuring the holder 4' in this way, reliable sterilization is possible even when the holders 4' are stacked, and many medical devices can be sterilized at once.

As shown in FIG. 7(B), the base portion 41 is particularly suitable for holding medical equipment such as a vial 63, and the upper surface of the medical equipment such as the vial 63 can be fixed by pressing from above with the gas-impermeable film 3, and the pad 423 can hold the side of the vial 63, etc., to prevent the vial 63 from rattling. The pad 423 also ensures a gap between the vial 63 and the cylindrical portion 42', allowing the sterilized fluid, etc. to be distributed well. The vent hole 424 is also designed to allow the sterilized fluid, etc. to be distributed well.

A method of storing a vial 63 as an example of a medical device in the holder 4' shown in Figures 6 and 7 (A) and (B) will be described. When the vial 63 is inserted from the bottom into the upper opening (on the side of the base plate 41) of the cylindrical portion 42, the peripheral portion of the bottom surface of the vial 63 abuts against the annular protrusion 48, and the side of the vial abuts against the pad 423, so that the vial is stored and held in the holder 4'.

As shown in Fig. 1, Fig. 2 (A) and (B), the gas-impermeable film 3 is peelably sealed to the annular flange portion 22 of the container body 2 by heat welding or the like, and seals the opening at the top of the container body 2. As the gas-impermeable film 3, polyethylene, polyethylene terephthalate, polyvinylidene chloride, or a film laminated with these can be used. For example, a film laminated with polyethylene terephthalate under polyethylene and an adhesive layer under the polyethylene terephthalate can be used. The gas-impermeable film 3 may be composed of a gas-impermeable film that does not transmit gas, water vapor, bacteria, etc., and Tyvek or the like laminated on the side that contacts the container body 2. Note that unlike vacuum bag packaging, the medical equipment container 1 is not covered entirely, but only the opening of the container body 2 is covered, which reduces materials. In addition, since the opening is covered with the gas-impermeable film 3, the exterior of the medical equipment container 1 can be sterilized.

The internal pressure of the medical device container 1 is reduced to less than atmospheric pressure. Therefore, as shown in FIG. 2B, the gas-impermeable film 3 is recessed inward of the medical device container 1 and abuts against the base portion 41 of the holder 4. Therefore, the holder 4 is fixed via the gas-impermeable film 3. In addition, when the medical device container is sterilized by radiation, the amount of gas inside is small, so the effect of radiation sterilization is high. Furthermore, the internal pressure of the medical device container 1 may be less than atmospheric pressure, but if it is 400 hectopascals (hPa) or more and less than 1013 hectopascals (hPa), there is no risk of a decrease in cleanliness due to deformation of the holder 4 or damage to the gas-impermeable film 3, and the holder 4 can be sufficiently fixed during transportation, which is preferable. Note that even if the gas-impermeable film 3 is not abutting against the base portion 41 of the holder 4, it is sufficient that the gas-impermeable film 3 is recessed to the vicinity of the base portion 41 of the holder 4. This is because the holder 4 is almost unable to move and is in a fixed state.
7B, in the case of a holder 4' that holds a vial 63, the gas impermeable film 3 abuts against the vial 63 (medical device). The rest is the same as in the case of the holder 4.

FIG. 8 is a longitudinal side view of the substrate part 41 of the holder 4 showing the state before and after deformation due to decompression, and the cylindrical part 42 and the like other than the substrate part 41 are omitted. As shown in FIG. 8, the substrate part 41 of the holder 4 is substantially flat before decompression, but when the film 3 comes into contact with the substrate part 41 due to decompression, it is depressed downward and deformed as shown by the substrate part 41' shown by the dashed line. The maximum displacement at this time is α. If the displacement is large, the contents may rub against each other during the displacement of the holder 4, which may reduce the cleanliness. Furthermore, the holder 4 may be damaged or deformed, which may impair the functions of the holder 4, such as positioning and holding the medical equipment, which are the original roles of the holder 4, or may cause the medical equipment to interfere with or fall off.
Therefore, it is preferable that the ratio (α/L) of the longitudinal length L of the substrate portion 41 of the holder 4 to the maximum displacement α of the substrate portion 41 of the holder 4 in the direction perpendicular to the bottom surface of the container body 2 is 0 < α/L ≦ 0.15.

Next, a method for manufacturing the medical device container 1 will be described. First, the holder 4 is placed inside the container body 2 either alone or in a state where a plurality of holders are stacked as shown in FIG. 2(B). After that, in a space decompressed to less than atmospheric pressure, for example, the gas-impermeable film 3 is wound up in a long length and then covered so as to cover the entire opening of the container body 2 (including the annular flange portion 22), and then a heat source is applied to the portion where the gas-impermeable film 3 and the annular flange portion 22 are in contact with each other, thereby heat-welding the gas-impermeable film 3 and cutting the gas-impermeable film 3 to an appropriate size at the same time. The gas-impermeable film 3 may be cut after heat-welding. In this way, the medical device container 1 can be obtained with an internal pressure less than atmospheric pressure. The process of decompression and heat-welding the gas-impermeable film 3 can be automatically performed by a chamber-type pack sealer machine (not shown) or the like. In this way, the gas-impermeable film 3 is sealed under reduced pressure, so that there is no variation in the reduced pressure state caused by the operator.
Furthermore, when the medical equipment container 1 thus manufactured under reduced pressure is placed under atmospheric pressure, the gas impermeable film 3 will be recessed towards the inside of the medical equipment container 1, as shown in FIG. 2(B).
Furthermore, in another embodiment, after sealing the gas-impermeable film 3 under normal pressure, the inside of the medical equipment container 1 may be reduced in pressure through an opening provided on the side or bottom of the container body 2, so that the gas-impermeable film 3 is recessed toward the inside of the medical equipment container 1.

Also, as shown in Fig. 9 (A) (B), the gas-impermeable film 3 may be sealed to the annular flange portion 22 in a space decompressed to less than atmospheric pressure in a state in which it is initially loosened downward. This allows the gas-impermeable film 3 to be made of a material that is less likely to stretch, or to reduce the reduction in thickness of the gas-impermeable film 3 due to stretching. If the opening area (including the annular flange portion 22) of the container body 2 before decompression is M1 (in the example of Fig. 2 (A), this corresponds to xy, where x is the longitudinal length and y is the lateral length), and the surface area of the gas-impermeable film 3 before decompression is M2, it is preferable that the ratio of M1 to M2 (M1/M2) is 0.70 ≦ (M1/M2) ≦ 0.99. If this ratio is too small, the gas-impermeable film 3 may wrinkle, which is undesirable for fixing the holder 4. From the viewpoint of slackness of the gas-impermeable film 3, it is more preferable that (M1/M2) ≦ 0.90.

REFERENCE SIGNS LIST 1 Medical device container 2 Container body 21 Container bottom 22 Annular flange 23 Step 3 Gas impermeable film 4 4' Holder 41 41' Base plate 42 42' Cylindrical portion 421 Annular flange 423 of cylindrical portion Pad 424 Vent 45 Support 47 Connection hole 48 Annular protrusion 49 Stay 50 Locking projection 501 Locking claw
502 Leg 51 Through hole 62 Cap 621 Top surface 622 Skirt 63 Vial

Claims (4)

A method for manufacturing a medical device container, which comprises a container body having an opening at the top, capable of stacking and housing a plurality of holders capable of holding a plurality of medical devices within the container body, and the opening being sealed with a gas-impermeable film, comprising:
Each of the plurality of holders is configured to include a plate-shaped base portion and a support pillar protruding from the base portion,
the support pillars are configured to have a length such that, when the plurality of holders are stacked in the container body while holding the medical devices, the medical devices are not brought into contact with a bottom surface of the container body or with a holder adjacent to the holder holding the medical devices;
With the gas impermeable film initially in a slackened downward state, the sealing is performed in a space reduced in pressure to 400 hectopascals (hPa) or more and less than 1013 hectopascals (hPa), thereby maintaining the internal pressure of the medical device container after the sealing at the reduced pressure value in the space where the sealing was performed;
The gas-impermeable film is brought into contact with the holder or with both the holder and the medical device held by the holder ;
A method for manufacturing a medical equipment container, characterized in that the ratio (M1/M2) of the opening area M1 of the container body before decompression to the area M2 of the gas-impermeable film sealed to the opening before decompression is 0.70≦M1/M2≦0.90 . The method for manufacturing a medical device container according to claim 1, characterized in that the ratio (α/L) of the longitudinal length L of the base plate part of the holder to the maximum displacement α of the base plate part of the holder in the direction perpendicular to the bottom surface of the container body is 0<α/L≦0.15. Each of the plurality of holders is configured to include a plurality of cylindrical portions protruding from the base portion,
3. A method for manufacturing a medical equipment container as described in claim 1 or 2, characterized in that each of the multiple cylindrical portions is configured to have multiple locking protrusions around its periphery that abut and hold the medical equipment against the cylindrical portion. 4. The method for manufacturing a medical equipment container according to claim 1, wherein the medical equipment is a cap to be placed on a stopper attached to the mouth of a medicine container.

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