CA2953650C

CA2953650C - Storage container for an apparatus for automated dispensing of individual medicament portions

Info

Publication number: CA2953650C
Application number: CA2953650A
Authority: CA
Inventors: Dietmar Gross
Original assignee: Becton Dickinson Rowa Germany GmbH
Current assignee: Becton Dickinson Rowa Germany GmbH
Priority date: 2014-07-03
Filing date: 2015-06-16
Publication date: 2022-10-18
Anticipated expiration: 2035-06-16
Also published as: WO2016000954A1; KR102423995B1; KR20170029493A; MX2016016772A; JP6937360B2; BR112016030617A2; EP2962956B1; EP2962956A1; AU2015283080A1; ES2609060T3; MX356673B; DK2962956T3; PT2962956T; AU2015283080B2; BR112016030617B1; JP2020058854A; CA2953650A1; JP2017523013A

Abstract

The invention relates to a storage container (1) for a device for automated dispensing of individual portions of medication. Corresponding devices are used in large numbers for blister dispensers and a main problem during use of these containers regards, among other things, the separation of contaminant particles which arise. To reduce loading with these particles, the storage container according to the invention comprises a housing (3a, 3b, 3c, 3d, 3e) enclosing a receiving chamber (2), the housing having a bottom surface (4), a separation device (100) arranged on the bottom surface (4) having at least one channel (102) for receiving at least one portion of medication, wherein the at least one channel (102) has an opening (103) facing the receiving chamber (2) and an opening (104) facing the bottom surface (4), wherein a contact region (10) arranged on the bottom surface (4) is assigned to the opening (104) facing the bottom surface (4), via which contact surface the portions of medication are guided during a movement of the separation device (100), and at least one recess (7) arranged in the bottom surface (4) outside of the contact surface (10) for receiving contaminant particles present in the container.

Description

Docket no.: 11821-026 STORAGE CONTAINER FOR AN APPARATUS FOR AUTOMATED DISPENSING
OF INDIVIDUAL MEDICAMENT PORTIONS
The invention relates to a storage container for individual medicament portions and in particular to a storage container for an apparatus for automated dispensing of individual medicament portions.
Apparatuses for automated dispensing of individual medicament portions, for example individual pills of a drug, are used particularly in blister packaging machines used in hospitals and blister centers, by means of which medicament portions can be blistered according to the physician directed intake times/ combinations. Corresponding blister packaging machines contribute to optimization of medicament management and drug logistics. With the help of modern blister packaging machines, the individual medicament portions are blistered within the shortest amount of time according to patients, and with a very small number of operators.
The different medicament portions blistered with the blister packaging machines are stored in a plurality of apparatuses for automated dispensing of individual medicament portions, whereby an individual blister packaging machine can comprise several hundred such apparatuses depending on the requirements of the installation site.
The apparatuses for automated dispensing of individual medicament portions typically comprise two main components, which are a storage container to store the individual medicament portions, whereby such storage container comprises, among others, at least a portion of a separation device required for dispensing individual medicament portions, and a container intake, on which the container is mounted. Such container intake can also comprise parts of the separation device (for example the motor and/or a control device). Generally, the two main components of the device for dispensing individual medicament portions are separate components; it is, however, also conceivable to implement the apparatus in one piece.
The apparatus for dispensing individual medicament portions is generally attached via the container intake to the blister packaging machine. If the storage container has to be refilled or Date Recue/Date Received 2022-02-02 Docket no.: 11821-026 medicaments are to be exchanged in the storage container, only the storage container is generally removed from the container intake and new medicaments are filled at a filling station.
During filling of the medicament portions into a receiving space of the storage container as well as during separation itself, it regularly happens that the smallest particles chip off the individual medicament portions and settle as undesired contamination particles in the storage container together with other carried-in or occurring contamination, or are carried out during dispensing.
On the one hand, the contamination particles impair the mechanics within the storage container and settle therein. Particularly during a change of the type of medicament portions in a storage container, it must be ensured that such container is cleaned intensely to avoid that medicament residues of a medicament previously stored in the storage container are carried out via the separation device from the storage container for a different, subsequently stored medicament, and, in extreme cases, are blistered, as well.
The formation of contamination particles in the storage container is virtually not avoidable, particularly for such medicaments which are frequently requested. Carrying-in of contamination particles during refilling of medicament portions is generally not avoidable, either.
It is the object of the present invention to provide a storage container for an apparatus for automated dispensing of individual medicament portions whereby the exposure to contamination particles is reduced.
This object is solved according to the invention by means of a storage container for an apparatus for automated dispensing of individual medicament portions.
The storage container according to the invention comprises a housing, which encloses a receiving space, and having a bottom surface, whereby the individual medicament portions are stored in the receiving space. A separation device is arranged on the bottom surface with at least one channel to accept at least one medicament portion, whereby the at least one channel has an opening facing the receiving space and an opening facing the bottom surface, whereby a contact area is associated with the opening facing the bottom surface, over which the medicament portions are guided upon a movement of the separation device.

2 Date Recue/Date Received 2022-02-02 Docket no.: 11821-026 The separation device in the storage container can comprise all the components, which are required for the separation of medicament portions stored in the receiving space. Depending on the exact configuration of the storage container and a container intake carrying the storage container, the separation device of the storage container according to the invention can also comprise just one part of the components of the separation device, whereby other parts (for example the drive and a control) are arranged in the container intake. Within this application, the term separation device comprises "complete" separation devices as well as just partial separation devices, which are such separation devices, which do not comprise all the required parts for a separation.
The storage container according to the invention further comprises at least one recess arranged in the bottom surface outside of the contact surface to receive contamination particles present in the container.
During separation, the medicament portions reach the channel via the opening facing the receiving space and further through the channel to the opening of the channel facing the bottom surface, where they rest on the bottom surface in the contact area. If an individual medicament portion is requested, the medicament portion, which is arranged in the channel at the opening facing the bottom surface and resting on the contact area of the bottom surface, is lead by means of the separation device towards an opening (which can also be part of the separation device) via the contact area in the housing / the bottom surface, via which the medicament portions leave the storage container.
On the one hand, contamination particles form during filling of the receiving space with individual medicament portions, and on the other hand, during separation itself, if, for example, an individual medicament portion hits the contact area of the bottom surface during separation or is guided along the same.
During operation of the blister packaging machine, particularly during separation, the storage container is constantly exposed to minor vibrations, which ensure that the contamination particles are constantly moved on the bottom surface. With the vibration-induced movement of the contamination particles, these inevitably reach the at least one recess in the bottom surface, in which they are retained. With the help of the recess, it is therefore ensured that contamination particles, which inevitably form during operation, are "caught". The contamination particles retained in the

3 Date Recue/Date Received 2022-02-02 Docket no.: 11821-026 recess, cannot be carried out any longer, or impair the mechanics, and general exposure to contamination particles is thus prevented effectively.
The separation device can operate according to principles known to a person skilled in the art and be constructed accordingly. Thus, it is conceivable, for example, that the separation device only has one channel to receive an individual medicament portion, whereby the channel is movable to a receiving position, in which the opening of the channel facing the bottom surface is cleared, and is movable into a dispense position, in which the opening of the channel facing the receiving space is closed and the opening facing the bottom surface is opened towards a dispensing opening in the housing / bottom surface.
1 0 Admittedly, a separation device constructed accordingly is kept very simple from the point of view of construction; the required speeds during dispensing of individual medicament portions, however, cannot be achieved with such separation device. For a preferred embodiment of the storage container according to the invention, it is therefore provided that the separation device comprises a rotor arranged on the bottom surface with a plurality of channels, whereby the rotor is arranged in such way that a gap is provided between the bottom of the rotor and the bottom surface, through which gap contamination particles can pass. Due to the plurality of channels in the rotor, individual medicament portions are always arranged in several channels, and dispensing an individual medicament portion can be achieved by turning the rotor only by a specific angle into a dispense position in which an individual medicament portion is dispensed from a respective channel via a dispensing opening in the housing.
The arrangement of the channels in the rotor depends on the exact constructive design of the separation device; it is, however, preferred that the channels are arranged at the outer circumference of the rotor and are open outwardly, i.e. the channels are formed by a plurality of webs at the circumference of the rotor. In such case, the housing is then fitted to the rotor in such way that a specific section of the housing is formed to accept the rotor and has a corresponding circular cylindrical section, the diameter of which is slightly larger than the outer diameter of the rotor.
Correspondingly arranged channels can be cleaned more easily. Further, access of medicament portions into the channels is simplified by a corresponding formation of the upper side of the rotor.

4 Date Recue/Date Received 2022-02-02 Docket no.: 11821-026 As indicated further above, the contamination particles are moved to the at least one recess in the bottom surface by means of the vibrations of the storage container. To support or guide such movement in the direction of the at least one recess and to ensure that a larger amount of contamination particles is moved faster to the at least one recess, one preferred embodiment is provided with at least one section of the bottom surface being funnel-shaped, whereby the rotor of the separation device is arranged in the center of the funnel-shaped section and the at least one recess formed in the bottom surface is arranged between the center of the funnel-shaped section and the contact area. For this embodiment, the at least one recess is thus formed within the circular contact area so that contamination particles are moved or guided not only by the vibration of the storage container but also gravity-induced due to the inclination of the funnel-shaped section of the at least one recess.
To be able to accept as many contamination particles as possible with a large area of the bottom surface, one preferred embodiment is provided with the at least one recess being formed as coaxial groove with respect to the rotor axis. In doing so, the exact design of the recess or the recesses depends on the specific construction of the separation device. For example, the recess can be formed circular, i.e. a recess formed as a groove surrounds the entire center of the funnel-shaped section and thus makes sure that as many contamination particles as possible are accepted. It may be required for other embodiments of the separation device that the recess is only formed as a circular section and a certain angular range remains clear, where no recess is arranged.
To further support the movement of the contamination particles towards the at least one recess, one preferred embodiment of the invention is provided with a plurality of cleaning agents at the bottom side of the rotor facing the bottom surface, which feeds the contamination particles to the at least one recess. Such cleaning agents can be formed as small brushes, for example, which are formed depending on the direction of rotation of the rotor at the bottom side of the rotor.
Provided that the storage container according to the invention has a separation device comprising a rotor, the rotor can be mounted on a rotor axis permeating the bottom surface. To prevent that contamination particles reach the axis area and cause a mechanical malfunction, one preferred embodiment is provided with a circular protrusion on the bottom surface, which is formed

5 Date Recue/Date Received 2022-02-02 Docket no.: 11821-026 coaxially with respect to the rotor, whereby the at least one recess is arranged outside the bottom surface, which is enclosed by the protrusion.
To further accelerate the movement of the contamination particles on the bottom surface towards the recess and to prevent a settling of the contamination particles on the bottom surface itself, one embodiment of the storage container according to the invention is provided with at least one section of the bottom surface being coated with a non-stick coating.
As mentioned, contamination particles reach the at least one recess due to the vibration occurring during operation, among others. To actively support the operation, for example, when the blister packaging machine does not actively blister, one preferred embodiment is provided with the storage container containing a vibration device, which exposes the storage container actively to vibration to actively move the contamination particles occurring during operation to the at least one recess.
Subsequently, the invention is described in more detail by means of a preferred embodiment with reference to the attached drawing, in which Figures 1A and 1B show perspective views of the embodiment of the storage container according to the invention, whereby Figure 1A shows the storage container in a perspective view from above and figure 1B shows the storage container in a perspective view from below, Figure 2 shows a further perspective view of the embodiment form of the storage container with the lid omitted, Figure 3 shows a top view onto the housing of the embodiment form, Figures 4, 5 and 6 show section views of the embodiment form, Figure 7 shows a further section view, whereby such view is rotated by 180 with respect to Figure 6, Figure 8 shows an enlargement of a section of Figure 7, and

6 Date Recue/Date Received 2022-02-02 Docket no.: 11821-026 Figures 9A and 9B show detailed views of a part of the separation device and components engaging therewith.
Figure 1A shows a perspective view of the embodiment form of the storage container 1 according to the invention for an apparatus for automated dispensing of individual medicament portions. The shown storage container is only part of the previously mentioned apparatus, which comprises a container intake as further main component. The container intake, however, is not part of the present application and is not explained in detail, herein.
The storage container 1 according to the invention comprises a housing with several housing sections, that is with an upper storage section 3a, a middle circular cylindrical section 3b to accept a portion of the separation device, a lower bottom section 3c as well as a handle section 3d. For the embodiment shown, the upper section 3a is closed with a lid 5.
It can be discerned in the perspective view from below according to Figure 1B, that an axis 106 is arranged in the lower housing section 3c, which is guided through an opening into a bottom surface 4 of the housing. Coaxially to axis 106, a protrusion 7 is arranged along a circular arc.
Viewing the storage container from above, this "protrusion" is depicted as recess 7 in the bottom surface 4.
Figure 2 shows another perspective view of the embodiment, whereby this representation omits the lid for a better view into the storage container.
In this representation, a rotor 101 can be discerned in the circular cylindrical section 3b of the housing, which is part of the separation device 100. Rotor 101 comprises (see particularly Figure 9B) a plurality of channels 102, which are arranged outwardly open at the circumference of the rotor by means of webs 108 and separated from another, and having an upper opening 103 and a lower opening 104. The rotor 101 itself is - as can be taken from Figure 9B -mounted on a rotor axis 106, which extends through the bottom surface 104 (see Figure 1B).
The perspective view shown in Figure 2 further shows another housing section 3e, which is formed tilted towards rotor 101. Housing sections 3a and 3e as well as rotor 101 define a receiving space 2, in which individual medicament portions are stored in the operating condition.

7 Date Recue/Date Received 2022-02-02 Docket no.: 11821-026 Figure 3 shows a top view onto the housing of the first embodiment of the storage container according to the invention, whereby parts of the separation device 100 were omitted from this embodiment, the rotor 101 and the rotor axis 106, among others. It can be discerned in Figure 3 that the circular cylindrical section 3b of the housing comprises a bottom surface 4 with a central rotor axis opening and a medicament dispensing opening 109. Recess 7 can also be discerned in the bottom surface, which is groove-shaped and coaxially formed with respect to the rotor axis opening.
Figure 4 shows a sectional view of the embodiment of the storage container according to the invention. In Figure 4, the housing section 3e can be discerned, which is tilted towards rotor 101.
Bottom surface 4 aligns with the circular cylindrical housing section 3b towards the bottom, which bottom surface is formed funnel-shaped towards the rotor axis opening, for the embodiment shown.
Rotor 101 and rotor axis 106 are arranged such that a gap 11 is formed between the bottom of the rotor and the upper side of bottom surface 4, through which gap contamination particles can move towards recess 7, whereby the recess is formed coaxially with respect to the rotor axis opening in the funnel-shaped bottom surface 4 as a circumferential groove.
On the left side of rotor 101, a "cut" is illustrated by means of a channel, on the right side by means of a web 108. At channel 102, opening 103, which is facing the receiving space 2, and opening 104, which is facing the bottom surface, can be discerned, whereby opening 104 aligns with an opening 109 in the bottom surface 4. The position of rotor 101 shown in figure 4 illustrates the dispensing position, i.e. in this position an individual medicament portion is fed via a correspondingly aligned channel to opening 109, via which it exits the apparatus for automated dispensing of individual medicament portions.
It can be discerned at the web, which is cut on the right side, that the web area strokes over a section of bottom surface 4, which is exposed in the area of the channels.
With respect to random positions of rotor 101 this results in a circular area at the outer bottom surface 4 for the embodiment of the rotor shown, which area is only interrupted by opening 109. Via such contact area 10 medicament portions lying in the channels are moved towards opening 109 (for separation). During such movement the smallest amounts of medicament particles can chip off of the individual medicament portions and contribute to contamination of the storage container.
Such contamination particles would finally be moved to recess 7 due to the constant vibration of the storage container

8 Date Recue/Date Received 2022-02-02 Docket no.: 11821-026 alone, and be retained therein. The bottom surface, however, is formed funnel-shaped for the embodiment shown, whereby such formation of the bottom surface contributes to the fact that contamination particles reach recess 7 (gravity-induced).
On the left side, a retention means 105 is shown, whereby a section of such retention means penetrates an opening 6 in the housing and partially engages in the channel aligned with opening 109. In doing so, it is prevented that another medicament portion slides down from above and is also dispensed, at the very moment an individual medicament portion is dispensed via opening 109. It follows that in case two medicament portions are to be dispensed two rotation steps of the rotor are required.
Below the contact area 10, a vibration device 12 is arranged at the housing, by means of which contamination particles can be moved to recess 7 by exposing the housing to vibration.
Figure 5 shows a further sectional view of the embodiment of the storage container according to the invention, whereby the rotor was omitted for this figure. Figure 5 illustrates the circular contact area 10 on the bottom surface. Figure 5 also illustrates opening 6 in the housing section 3b.
For the sectional view shown in Figure 6, rotor axis 106 has also been omitted and it can be discerned that a protrusion 9 is formed coaxially with respect to the central rotor axis opening in bottom surface 4 - that is between the rotor axis opening and recess 7. With such protrusion it can be prevented that, if contamination particles should get above the recess, such particles reach the mechanically sensitive area at rotor axis 106.
Figure 7 shows the illustration shown in Figure 6 rotated by 180 and this view shows the section 105b of the retention means 105 engaging with a channel. Section 105b engaging with the channel is either formed elastically so that it is deformed by a web (e.g.
brush-type formation of the engaging section 105b), or retention means 105 comprises an elastic section so that section 105b, which is engaging with the channel, can be pressed out from the channel during movement of the rotor.
As can be seen from Figure 7, recess 7, which is coaxial with respect to the central opening in the bottom surface, is not completely circular, i.e. formed without interruption; rather, a part of

9 Date Recue/Date Received 2022-02-02 Docket no.: 11821-026 bottom surface 4 has no recess. The reason for this is that a stop mechanism 107 is formed for such area, which is engaging with the rotor axis 106. Figure 7 only shows a stop means 107 from such mechanism, which engages with that area where the rotor axis is typically arranged.
Figure 8 illustrates the previously mentioned details in a sectional enlargement.
Figures 9A and 9B show detailed views of a separation device as well as components engaging operatively therewith. The separation device comprises, amongst others, rotor 101 with a plurality of channels 102, which are separated from another by webs 108. At the bottom 111 of rotors 101 a plurality of cleaning agents 110 are arranged, which contribute to moving the contamination particles lying on the bottom surface 4 between circular contact area 10 and recess 7 to the recess, whereby the alignment of cleaning agents 110 depends on the rotational direction of the rotor.
Figure 9A further shows stop mechanism 107, which engages operatively with rotor axis 106.
In doing so, stop mechanism 107 comprises, among others, an at least sectionally elastic arm 107c, which can engage with recesses of a toothing 106b formed in rotor axis 106 (see Figure 9B). Such stop mechanism serves to determine the rotor for specific operating conditions so that a non-intended rotation of the rotor can be avoided. In doing so, unintended dispensing of a medicament portion can be prevented. For example, the stop mechanism can arrest the rotor if the storage container is removed from the container intake. In doing so, it can be provided, for example, that during fitting of the storage container onto the container intake, the stop mechanism 107 is made to disengage with toothing 106b via the at least sectionally elastic arm 107c, but made to reengage with the toothing during removing of the storage container and thus arresting the rotor.
Date Recue/Date Received 2022-02-02

Claims

1. Storage container for an apparatus for automated dispensing of individual medicament portions, comprising a housing enclosing a receiving space having a bottom surface, a separation device arranged on the bottom surface with at least one channel to receive at least one medicament portion, whereby the at least one channel has an opening facing the receiving space and an opening facing the bottom surface, whereby the opening facing the bottom surface is associated with a contact area on the bottom surface, over which contact area the medicament portions are guided upon a movement of separation device, at least one recess arranged in the bottom surface outside of the contact surface to receive contamination particles present in the container.

2. Storage container according to claim 1, characterized in that the separation device comprises a rotor arranged on the bottom surface with a plurality of channels, whereby the rotor is arranged in such way that a gap is provided between the bottom of the rotor and the bottom surface, through which gap contamination particles can pass.

3. Storage container according to claim 2, characterized in that at least one section of the bottom surface is formed funnel-shaped, whereby the rotor is arranged in the center of the funnel-shaped section, and in that the at least one recess formed in the bottom surface is arranged between the center of the funnel-shaped section and the contact area.

4. Storage container according to claim 3, characterized in that the at least one recess is formed as a coaxial groove with respect to the rotor axis.

5. Storage container according to any one of claims 2 to 4, characterized in that the rotor comprises a plurality of cleaning agents at the side of the rotor facing the bottom surface, which feed contamination particles to the at least one recess.

6. Storage container according to any one of claims 2 to 5, characterized in that a circular protrusion coaxial to the rotor axis is formed on the bottom surface, whereby the at least one recess is arranged outside of bottom surface, which is enclosed by the protrusion.

7. Storage container according to any one of claims 1 to 6, characterized in that at least one section of the bottom surface is coated with a non-stick coating.

8. Storage container according to any one of claims 1 to 6, characterized in that the storage container comprises a vibration device.