WO2023135418A1

WO2023135418A1 - Container and uses thereof

Info

Publication number: WO2023135418A1
Application number: PCT/GB2023/050048
Authority: WO
Inventors: Jonah ZEMO; Nitin Parekh; David Appleby
Original assignee: Yourmedpack Limited
Priority date: 2022-01-13
Filing date: 2023-01-11
Publication date: 2023-07-20

Abstract

The present invention relates to a medicine container for containing and indicating a medicine regime comprising: a blister sheet formed of a substantially planar substrate having a plurality of compartments for receiving one or more medicinal products and an interface portion for being received in or on an electrical hardware component; a flexible closure film for adhering to the blister sheet and sealing over the compartments, wherein the closure film has a plurality of removable or pierceable portions defined by a frangible outline which are crossed by a plurality of parallel electrically conductive circuits, each of said removable or pierceable portions being alignable with each compartment and one or more electrically conductive circuits extending to and alignable with the interface portion; and an electronic hardware component which is adapted to receive the interface portion so as to enable electrical contact of the one or more electrically conductive circuits with electrical connectors of the electronic hardware component and wherein the interface portion and/or the electrical hardware component is configured so as to urge the one or more electrically conductive circuits together with the electrical connectors of the electronic hardware component. The invention also relates to a kit of parts for making a medicine container and methods for making medicine containers.

Description

Container and uses thereof

Field of the Invention

The present invention relates to electronic medicine containers for containing, indicating and tracking medicine regimes.

Background of the Invention

For patients on complex medication regimes (or indeed for patients who are suffering from memory loss) it is well known for the pills to be dispensed by a pharmacy into trays often having an array of 28 compartments or cells. The compartments are arranged as four compartments per day and seven lines of four daily compartments.

To prevent degradation of the pill, the compartments are generally sealed with an impermeable film adhered to the area surrounding each of compartments in the tray. Typically the trays are formed using a vacuum/pressure moulding. Once the pills have been dispensed into the compartments or the tray is populated the film adhered to the tray.

A card identifying the intended day and/or part of the day at which the pills should be taken may be incorporated with to the sealed tray. Indeed, this card can be applied before the tray is populated. The card may also incorporate the compartment sealing film and adhesive for adhering the firm around the compartments.

One example of a container suitable for holding pills or personal medication is disclosed in WO2016/128730. This document discloses a blank for use in the manufacture of a blister pack, the blank comprising perforations arranged in a pattern to effectively distribute stresses by the perforations when the blank is under tension by rollers and/or subjected to flex.

One problem associated with smart packaging used to store personal medication has been the reliability of the recording when a compartment seal is broken. One factor that affects this is that the breaking of the seal itself is either not complete is broken prematurely before the compartment has been accessed. Another problem relates to the recording device attached to the electrical circuits and programmed to register when a seal is broken. In some instances total failure has been associated with improperly connected electrical circuits. Connecting a recording device to a substantially planar blister and seal comprising a plurality of electronic circuits has proved technically challenging thus far.

It is an object of the present invention to overcome one or more of the abovementioned problems. It is also an object of the present invention to provide smart packaging which enables electrical circuits to be more reliably integrated with and connected to reading devices.

Summary of Invention

In accordance with a first aspect of the present invention, there is provided a medicine container for containing and indicating a medicine regime comprising: a blister sheet formed of a substantially planar substrate having a plurality of compartments for receiving one or more medicinal products and an interface portion for being received in or on an electrical hardware component; a flexible closure film for adhering to the blister sheet and sealing over the compartments, wherein the closure film has a plurality of removable or pierceable portions defined by a frangible outline which is crossed by a plurality of parallel electrically conductive circuits, each of said removable or pierceable portions being alignable with each compartment and one or more electrically conductive circuits extending to and alignable with the interface portion; and an electronic hardware component which is adapted to receive the interface portion so as to enable electrical contact of the one or more electrically conductive circuits with electrical connectors of the electronic hardware component and wherein the interface portion and/or the electrical hardware component is configured so as to urge the one or more electrically conductive circuits together with the electrical connectors of the electronic hardware component.

The interface portion of the medicine container may optionally comprise a fold line indicating where to fold the interface portion.

The substrate and blister sheet of the medicine container may additionally be deformable so as allow the interface portion to be folded, but retains a degree of resilience when folded so as to urge the electrically conductive circuits together with the electrical connectors of the electronic hardware component when being received.

The medicine container may additionally be used for tracking the correct dosage of a medicine regime and patient compliance with said regime.

The compartments may contain either a single medicinal product or single dose of a medicinal product. Alternatively, the compartments may contain two or more medicinal products, which could be either be two or more separate medicines intended to be taken at the same time or two or more doses of the same medicinal product.

The present inventors have discovered that, for certain embodiments, providing a foldable interface portion greatly enhances the reliability of connecting the electrically conductive circuits of the closure film to electrical connectors of the electrical hardware components.

The container may further comprises a cover that is extendible around the blister sheet and over the closure film.

In some embodiments, the cover may be formed of carton board (or similar such material). In other embodiments, the cover may be formed of a substantially rigid material (such as a plastics material). The cover may be hingedly attached to a base which extends around and/or under the blister sheet. If a base is provided, the base may comprise substantially parallel guides extending outwardly along he sides of the base so as to enable the correct location of the blister tray and alignment of the electrically conductive circuits with the electrical connectors of the electronic hardware component.

Each parallel electrically conductive circuit will extend to the interface portion. That is to say that circuit for each blister compartment may extend to the interface portion. Alternatively, each parallel electrically conductive circuit may be connected to a separate circuit or arranged so that it can be determined from the interface portion that a parallel electrically conductive circuit is operational or has been broken.

The foldable interface portion will preferably be resiliently biased towards an unfolded configuration. The biasing may simply be by means of the material used for the blister sheet being flexible and having memory so that it wants to assume an unfolded stated. The foldable interface portion may further be preferably biased by a spring action of the blister sheet being bent and wishing to return to an unfolded stated. It will be apparent to the skilled addressee that plastics materials which are commonly used for producing blister sheets could be used in conjunction with the invention.

The foldable interface portion may be pre-formed or pre-stressed with a fold line so as to facilitate folding and also provide a visual cue to the individual filling and preparing the container. The foldable interface portion may also have a raised feature that extends from one edge to an opposing edge of the portion whereby the raised feature indicates and/or facilitates folding.

The electronic hardware component may comprise an aperture for receiving the folded interface portion. Preferably, the aperture is wider than the combined width of the blister sheet and closure film. The width refers to the vertical width of the aperture. The closure film and/or cover may comprise visual indicators indicating times or the day and/or days of the week for each compartment. For example, the indicators may relate to a dosing regime of ‘Morning, ‘Midday, ‘Teatime and ‘Bedtime’. The indicators may also relate to dosing days such as ‘Monday’, ’Tuesday’ or “1”, “2” etc. The present invention is particularly suited to helping patients comply with the required dosage regime by reminding them of the doses they have had and also which does is next. The doses may be for administration over 1 week or over 1 month.

The electronic hardware component may be programmed to detect when an electrically conductive circuit has been broken and therefore ascertain that the required does has been taken. Obviously, if the electrically conductive circuit has not been broken then the hardware component can ascertain that the required dose has not been taken. The electronic hardware component may be programmed to issue an alert to the user, carer or medical professional.

The electronic hardware component may additionally, or alternatively, be programmed to detect when the one or more medicinal products are present or absent in a compartment. In certain aspects, the one or more medicinal products may be a liquid, which may be located directly in the compartment or located within a vial (or other such similar container). Furthermore, the electronic hardware component may additionally, be programmed to detect the size or quantity of the medicinal products in a compartment.

The detection of the breaking of an electrically conductive circuit (or an intact electrically conductive circuit) may be communicated with a remote server by the electrically conductive circuit by means of a communication methods, such as radio transmission, Bluetooth®, Wi-Fi, mobile phone networks and other communications protocols which will be apparent to the skilled addressee.

The detection of the breaking of an electrically conductive circuit may be logged or communicated to a user. This may be by means of a noise, or visual indicator on the electrical hardware component. Preferably, the electronic hardware component comprises a user interface. More preferably, the user interface comprises a visual display unit. A visual display unit will allow messages to be displayed and programming menus to be displayed.

Each compartment may contain one or more doses of one or more medicaments. For example, each compartment may contain one standard dose, or two standard doses of two separate medicaments.

The medicaments may be in a number of formats but will preferably be in a standard form such as a tablet, pill or lozenge.

The flexible film may be adhered to the blister sheet using an adhesive layer located on either the blister sheet or the flexible film. The adhesive may be covered by a backing material so as to protect the adhesive prior to the closure film being adhered to the blister sheet. Preferably, the backing material can be easily peeled off from the adhesive prior to the blister sheet and flexible film being adhered to one another.

The blister sheet preferably has a thickness of between about 180 mu and about 1800 mu.

The container may be in the form of a kit, which is assembled after an individual’s medicaments have been inserted into the compartments. The kit allows an individual’s medicaments to be easily packaged by themselves, a family member, pharmacist, care provider or healthcare professional. The medicaments may also be packaged for use in clinical trials, where compliance with a dosage regime is particularly important.

The cover will preferably form a wallet or container. It may be made from a number of materials, such as carton board or a plastics material. The wallet may include additional indicators and/or perforated/breakable portions which align with the blister compartments. The wallet may also include areas dedicated for labels to be applied, such labels detailing the patient name, identity of the medicament(s) and dosage regime.

In accordance with a second aspect of the present invention, there is provided a kit of parts for forming a medicine container for containing and indicating a medicine regime, the kit comprising: a blister sheet formed of a substantially planar substrate having a plurality of compartments for receiving one or more medicinal products and a foldable interface portion for being received in or on an electrical hardware component; a flexible closure film for adhering to the blister sheet and sealing over the compartments, wherein the closure film has a plurality of removable portions defined by a frangible outline which is crossed by a plurality of parallel electrically conductive circuits, each of said removable portions being alignable with each compartment and one or more electrically conductive circuits extending to and alignable with the interface portion and; an electronic hardware component which is adapted to receive the foldable interface portion when in a folded configuration so as to enable electrical contact of the one or more electrically conductive circuits with electrical connectors of the electronic hardware component and wherein the folded interface portion urges the one or more electrically conductive circuits against the electrical connectors of the electronic hardware component.

It will be understood that the container as detailed with reference to the first aspect of the present invention, will also have interchangeable and similar features to the kit of parts according to this second aspect. ln accordance with a third aspect of the present invention, there is provided a method of forming a medicine container for containing and indicating a medicine regime comprising; providing a blister sheet formed of a substantially planar substrate having a plurality of compartments for receiving one or more medicinal products and an interface portion for being received in or on an electrical hardware component; providing a flexible closure film for adhering to the blister sheet and sealing over the compartments, wherein the closure film has a plurality of removable or pierceable portions defined by a frangible outline which is crossed by a plurality of parallel electrically conductive circuits, each of said removable or pierceable portions being alignable with each compartment and one or more electrically conductive circuits extending to and alignable with the interface portion; providing an electronic hardware component which is adapted to receive the foldable interface portion so as to enable electrical contact of the one or more electrically conductive circuits with electrical connectors of the electronic hardware component and wherein the interface portion and/or the electrical hardware component is configured so as to urge the one or more electrically conductive circuits together with the electrical connectors of the electronic hardware component; filling the compartments of the blister sheet with one or more medicinal products; adhering the flexible closure film over the compartments such that the removable or pierceable portions are aligned with each compartment and interface portion; bringing the interface portion of the of the blister sheet in contact with one or more electrically conductive circuits of the interface portion so that the electronically conductive circuits are in contact with, and urged together with, the electrical connectors of the electronic hardware component. Additionally, and in accordance with the third aspect of the present invention the interface portion may be foldable and the method of forming a medicine container comprises folding the interface portion before bringing together the interface portion and the one or more electrically conductive circuits of the interface portion, and wherein the one or more electrically conductive circuits of the interface portion are housed within a aperture of the electronic hardware component and the substrate and blister sheet are deformable so as allow folding of the interface portion whilst retaining a degree of resilience when folded so as to urge the electrically conductive circuits together with the electrical connectors of the electronic hardware component when received in the aperture.

In common with other aspects of the invention, the method may additionally be used for tracking the correct dosage of a medicine regime has been taken and assessing patient compliance with said regime.

Furthermore, the compartments may contain either a single medicinal product or single dose of a medicinal product. Alternatively, the compartments may contain two or more medicinal products, which could be either be two or more separate medicines intended to be taken at the same time or two or more doses of the same medicinal product.

The method of this third aspect will preferably be used to form a container as described herein above with reference to the first aspect. Furthermore, the method of this third aspect will preferably be used to form a container using a kit of parts as described herein above with reference to the second aspect.

The described and illustrated embodiments are to be considered as illustrative and not restrictive in character, it being understood that only the preferred embodiments have been shown and described and that all changes and modifications that come within the scope of the inventions as defined in the claims are desired to be protected. The optional features set out herein may be used either individually or in combination with each other where appropriate and particularly in the combinations as set out in the accompanying claims. The optional features for each aspect or exemplary embodiment of the invention as set out herein are also to be read as applicable to any other aspect or exemplary embodiments of the invention, where appropriate. In other words, the skilled person reading this specification should consider the optional features for each exemplary embodiment of the invention as interchangeable and combinable between different exemplary embodiments.

It should be understood that while the use of words such as “preferable”, “preferably”, “preferred” or “more preferred” in the description suggest that a feature so described may be desirable, it may nevertheless not be necessary and embodiments lacking such a feature may be contemplated as within the scope of the invention as defined in the appended claims. In relation to the claims, it is intended that when words such as “a,” “an,” or “at least one,” are used to preface a feature there is no intention to limit the claim to only one such feature unless specifically stated to the contrary in the claim.

Detailed Description

The present invention will now be further described with reference to, and as illustrated in, the following figures which show:

Figure 1 is an exploded perspective view of the medical container of the present invention, illustrating the main elements of the container of a cover, blister film with integrated circuit and blister tray.

Figure 2 is a plan view of a combination of a blister film and blister tray. Figure 3 are views of the blister tray, where A shows a plan view of the blister tray, B shows the cross-section of the folded portion, C and D are both side views of the blister cells.

Figure 4 are plan and cross-sectional views of blister sheets having different fold line profiles, where A is a plan view of a first embodiment and D is the cross-section of the related tongue, B is a plan view of a second embodiment showing E the cross-section of its tongue and C is a third embodiment showing F cross-section of the tongue.

Figure 5 shows a plan view of a blister tray.

Figure 6 shows details of the cover portion, where A is plan view of a cover portion and B is perspective view of a cover portion.

Figure 7 shows plan views of the card blank, blister film and blister tray combined, where A shows the monitoring device in situ, whereas B is without the monitoring device.

Figure 8 is a view section of a number of blister cells which have been sealed with the blister film and overlaid by the carton blank.

Figure 9 is a close-up view of the blister tray with a blister film in situ where the electronic interface portion has been folded in preparation for connection with the monitoring device (not shown).

Figure 10 shows a number of views of the blister tray and blister film being prepared by the bending of the electronic interface portion so as to be received within the monitoring device, where A - E illustrate the various steps involved in folding a portion of the blister tray and blister film and connecting the monitoring device to the blister.

Figure 11 is a cross-sectional view of the electrical connectors within the monitoring device. Figure 12 is an alternative embodiment of the monitoring device, where the card blank has been replaced with a rigid plastics base and cover and the monitoring device is integrated into the plastics base.

Figure 13 shows a number of views of the embodiment has shown in Figure 12, where, A - D are steps for opening and inserting a blister film ready for use.

Examples

The present invention will now be described in further detail with reference to the following examples, which are provided for illustration only.

With reference to Figure 1 , there is generally shown a rectangular card blank 10 which is divided into three portions, namely a cover portion 17, a blister cover portion 19 and a fold portion 16. The cover portion 17 and blister cover portion 19 are equally sized and are connected by an elongate thin fold portion 16. The blister cover portion 19 has a large monitoring device aperture 18 and a plurality of smaller blister apertures 20 located beneath. The blister film 12 has a number of blister cell cover portions which correspond in dimensions and in position relative to the blister apertures 20 in the card blank 10. Towards the top of the blister film 12, is an electronic interface portion 24 which is in the shape of a tongue extending from the upper edge and along the length of electronic interface portion 24 is a film fold line 26.

The underside of the blister film 12 is covered in adhesive and may additionally be provided with a backing layer (not shown) in instances when the blister film 12 has not been already applied to the blister tray 14. The blister tray 14 has a monitoring device aperture 34 which largely corresponds to the shape and dimensions of the monitoring device aperture 18 on the card blank 10. Furthermore, the blister tray 14 has a blister tongue tray which is of the same dimension and location as the electronic interface portion 24 of the blister film 12. The blister tray 14 has a number of blister cells 38 which correspond to location and opening dimensions of the blister cell cover portion 22 and the blister aperture 20. The blister tray is formed of a substantially planar single piece of mouldable material with a thickness of between about 180 mu and 1800 mu. In construction, the blister film 12 is adhered over the blister tray 14 after medicaments (such as pharmaceutical tablets) are inserted into each of the blister cells 38). The card blank 10 is then applied over the blister film 12 and the cover portion 12 used to cover the blister apertures 20 located on the blister cover portion of the card blank 10.

With reference to Figure 2, there is shown the blister film 12 which has been applied over a blister tray 14. Along the top edge of the blister film 12 is a blister tray tongue 36 along which extend a number of electrical contacts 14, each of which correspond to an individual circuit 42 for an individual blister cell. Each blister cell has an individual blister cell film cover 44 which incorporates an electrical circuit which is connected to the electrical contact 40. Each individual blister cell film cover 44 comprises a cell connector 46 which extends across the width of the blister cell and connects to an upper frangible circuit line 48 and a lower frangible circuit line 49. Blister film 12 also has a written indicator 50 which informs the user of a particular fact, such as the day of the week, the dosage or simply consecutive numbers indicating the number of doses provided in the device. The paths of individual circuit 42 may be formed by any number of methods suitable for depositing electrically conductive material such as flexographic printing.

With reference to Figure 3, there is shown a blister tray which is identical to that shown in Figure 1 , although Figure 3C and Figure 3D both show side views of the blister tray 14 and Figure 3B show the cross-sectional profile of the blister tray tongue 36 when folded along fold line 28.

With reference to Figure 4, there are shown three different embodiments of a blister tray 14 where in a first embodiment the blister tray 70 has a foldable tongue 71 with a rounded “U” cross-sectional fold line profile 72. The second embodiment shown in Figures 4B and E show a blister tray 74 having a foldable tongue 75 with an almost triangular “V” cross-sectional fold line profile 76. Lastly in the third embodiment shown in Figures 4C and 4F, there is shown a blister tray 78 having the foldable tongue 79 with a rectangular cross-sectional fold line profile 80. The fold line profiles 72, 76, 80 enable a clear indication to the user where to fold the tongue 71 , 75, 79, but also assist with the folding and can be used to vary and introduce the right resilience required to urge the electrical connectors against the connectors in the monitoring device. The fold line profiles 72, 76, 80 are raised so that it is proud of the surface of the blister sheet 7 by between about 0.5 cm and about 0.75 cm. The raised feature 10 facilitates folding of the tongue 71 , 75, 79, so that when folded, the tongue 71 , 75, 79, has a greater thickness than the substantially planar blister sheet. The profiles may be introduced using a creased rule blade on the cutter.

With reference to Figure 5, there is shown a further embodiment where the blister tray 81 comprises exterior parameter of the blister cell 82 and an internal circuit 86. Reference to number prime (') is to denote similar features with reference to earlier embodiments.

With reference to Figure 6, there is shown the card blank 10 in plan view (A) and perspective view (B) and illustrates the direction of folding the blank along the fold portion 16 as indicated by the fold direction 21 .

With reference to Figures 7A and 7B, there is shown a card blank, blister film and blister tray combined together in order to form the device of the present invention. Figure 7A shows the monitoring device 100 being in position, having been placed over the blister tray tongue 36 and connecting with the electrical connectors 40.

With reference to Figure 8, there is shown a close-up of a number of blister apertures 20 overlaying blister cell cover portions 22 and showing the upper frangible circuit line 48, lower frangible circuit line 49 and monitoring device 100 in situ. With reference to Figure 9, there is shown the blister film 12 which has been overlaid over a blister tray 14. The blister tray tongue 36 has been folded along the fold line 28 and film fold line 26 in order to present electrical contacts 14 along the edge of the fold and also to allow them to present the electrical contacts 14 either side of the combined blister film and blister tray.

With reference to Figure 10, there is shown details of how the blister tray 14 is handled so as to be inserted into the monitoring device 100. Figures 10A - 10B show the manipulation of the blister tray tongue 36 so as to fold it back up on itself along the blister fold line. The monitoring device 100 has a cavity 102 which is able to receive the blister tray tongue so as to present the electrical contacts 40 to the row of the first electrical connectors on 04 and second row of electrical connectors 106. Figure 10E shows the folded blister tray 36 being received in cavity 102.

With reference to Figure 11 , there was shown a cross-section of the cavity 102 of the monitoring device 100 illustrating the first row of electrical connectors 104 and second row electrical of connectors 106 with both rows being bent back on each other in order to provide some form of resilience, once the blister tray tongue 36 has been inserted into the cavity 102 in the direction 110. The distance 108 can be adjusted to receive either a folded blister tray tongue 36 or adapted to receive any alternative profiles of the non-foldable tongues as shown in Figure 4.

With reference to Figure 12, there was shown a further embodiment of the present invention, wherein rather than the device comprises a rigid plastics cover, rather than using a card blank as illustrated in earlier embodiments. Furthermore, the monitoring device 208 is integrally formed with the cover, rather than it being separate. Figure 12A shows a generally rectangular base 202 to which a monitoring device 208 is integrally formed. The device 200 utilises a similar blister film and blister tray arrangement has in earlier embodiments and the blister cells 206 can be seen through apertures located in the front cover 204. With reference to Figure 12B, the base 202 can be seen to integrally house the monitoring device 208 which has a cavity 220 along its underside. A number of hinge holes 211 are located along the left hand side of the base 202 which received hinge tabs 205 located on the front cover 204 so as to enable the front cover 204 to hinge relative to the base 202. The front cover 204 provides a monitoring device aperture 207 so as to allow the cover to fit around the monitoring device 208, but also allow it to protrude therethrough. Blister apertures 209 permit access to the blister cells 206. In this embodiment, the electrical connectors 212 are located on the tongue of the blister pack 210, but are not folded, but rather inserted directly into the aperture 220 of the monitoring device 208. In order to allow correct alignment of the electrical connectors 212 with those housed within the monitoring device 208, there is provided a left hand side guide 214 and a right hand side 216 which extend along the lengths of the base 202 parallel to one another and allow the user to slide the left hand side edge 218 and right hand side edge (not shown) along the guides 214 and 216 so as to allow the electrical connectors 212 to correctly align with those in the monitoring device 208. Once the blister pack 210 has been correctly inserted, an upstanding tab 222 helps to prevent dislodgement of the blister pack 210 away from the monitoring device 208. Lastly, the base 202 is provided with indentations 224 which are deeper than the dimensions of the blister cells of the blister pack 210 so as to accommodate the underside of the tray.

With reference to Figure 13, there is shown the same embodiment as illustrated in Figure 12, where in Figure 13A, an empty device 200 is opened by lifting the right hand side of the front cover 204 and rotating it using the hinge tabs 205 which are inserted into the hinge holes 211. The blister pack 210 is then inserted into the pack and the electrical connectors 212 are urged into the aperture 220 of the monitoring device 208 using the guides 214 and 216 to help correctly position and locate the blister pack within the packaging. In Figures 13C and 13D, the user closes the front cover 204 so it is in the closed configuration and shown in Figure 13D and device is ready for use.

Referring to Figures 1 - 3 and Figures 6 - 11 , there is provided a device which is used for monitoring patent compliance and/or encouraging patent compliance with a pharmaceutical regime which incorporates an electronic monitoring device for collecting data on the patient consumption of pharmaceutical products. The device can be constructed and/or filled either at the pharmacy or point of care by a health care worker or indeed by a family member if desired. The principle is that the blister cells 38 of the blister tray 14 are each filled with a single dose of medicine. The medicine can be in a solid, powder or even liquid form. Furthermore, the medicine may be a combination medicine where each cell 38 contains two or more medicines which a patient is required to take at the same time. Once the blisters 38 have been filmed with the appropriate medicine, the backing layer (not shown) of the blister film 12 is removed so as to expose an adhesive layer and the blister film 12 can be applied over the blister tray 14, thus sealing each of the cells 38. When the blister film 12 is being applied to the blister tray 14, it is aligned so as to allow the alignment of the of the electronic interface portion 24 with that of the blister tray tongue 36. The card blank 10 is additionally overlaid over the blister film 12 and the cover portion 17 folded along fold line 16 in direction 21 so as to cover the blister cell cover portions 22 which are exposed through the blister apertures on the card blank. The resulting device resembles the device as shown in Figure 7B. Steps as shown in Figure 10A - 10B in order to fold the blister tray tongue 36 along the fold line 28 with the blister film 12 attached results in the electrical contacts 40 being exposed as shown in Figure 9. The monitoring device is then slid over the folded blister tray tongue 36 so that it is received in the cavity 1 and 2 of the monitoring device 100. Electrical contacts 40 on either side of the folded tongue 36 contact the row of first electrical connectors 104 and the row of second electrical connectors 106 and the combination of the resilience in the blister tray and blister film material after being folded and the resilience of the row of first electrical connectors 104 and row of second electrical connectors 106 ensure complete electrical connection between the monitoring device 100 and the circuits of the blister film 12.

The monitoring device 100 is pre-programmed with the correct dosage regime for a particular individual and will monitor access to each and every blister cell. If need be, the monitoring device 100 can be connected to a database or alert system so as to alert healthcare professionals to excessive consumption and/or incorrect or insufficient consumption of the medicine. If required, an intervention by a healthcare worker may be required. The monitoring device 100 establishes whether a blister cell 38 has been accessed, by detecting the breakage of the individual electrical circuit 42 which is connected to an individual blister cell film cover 44. As the blister cell cover 44 has a upper frangible circuit line 48 and a lower frangible circuit line 49 connected together with a cell connector, the severing of either of the frangible circuit lines will break the individual circuit and this in turn can be detected by the monitoring device 100.

After all the medicine in all of the cells has been consumed, the blister film and blister tray can simply be removed from the card blank 10, the monitoring device 100 also removed and either a new blister film and blister tray inserted into the monitoring device and the previous card blank 10 utilised or alternatively a new card blank 10 could be utilised in alternative embodiments to the one described above, Figure 4 shows that non-foldable tongues with different profiles may be used in place of folding the blank material in order to provide resilience. The profiles shown in Figure 4 are illustrative of different tongue profiles which could be used in order to urge the electronic interface portion 24 against a row of electrical connectors within the monitoring device.

Referring now to Figures 12 and 13, an alternative embodiment is illustrated which works on a similar principle as the earlier embodiments, however, a rigid case is formed using a plastics base and plastics front cover whereby the monitoring device 208 is integrally formed with the base 202, and the blister pack 210 is inserted into the monitoring device 208 in a similar fashion as to earlier embodiments with the exception of folding the tongue.

It will be appreciated that numerous modifications to the above described container, methods and uses may be made without departing from the scope of the invention as defined in the appended claims.

Claims

1 . A medicine container for containing and indicating a medicine regime comprising: a blister sheet formed of a substantially planar substrate having a plurality of compartments for receiving one or more medicinal products and an interface portion for being received in or on an electrical hardware component; a flexible closure film for adhering to the blister sheet and sealing over the compartments, wherein the closure film has a plurality of removable or pierceable portions defined by a frangible outline which is crossed by a plurality of parallel electrically conductive circuits, each of said removable or pierceable portions being alignable with each compartment and one or more electrically conductive circuits extending to and alignable with the interface portion; and an electronic hardware component which is adapted to receive the interface portion so as to enable electrical contact of the one or more electrically conductive circuits with electrical connectors of the electronic hardware component and wherein the interface portion and/or the electrical hardware component is configured so as to urge the one or more electrically conductive circuits together with the electrical connectors of the electronic hardware component.

2. The container as claimed in claim 1 , wherein the interface portion is foldable and optionally comprises a fold line indicating where to fold the interface portion.

3. The container as claimed in claim 2, wherein the substrate and blister sheet are deformable so as allow the interface portion to be folded, but retains a degree of resilience when folded so as to urge the electrically conductive circuits together with the electrical connectors of the electronic hardware component when being received. The container as claimed in claim 1 , wherein the container further comprises a cover that is extendible around the blister sheet and over the closure film. The container as claimed in either claim 1 or 2, wherein each parallel electrically conductive circuit extends to the interface portion. The container as claimed in any of claims 2 to 5, wherein the foldable interface portion is resiliently biased towards an unfolded configuration. The container as claimed in any of claims 2 to 6, wherein the foldable interface portion is pre-formed or pre-stressed with a fold line. The container as claimed in any of claims 2 to 7, wherein the foldable interface portion has a raised feature that extends from one edge to an opposing edge of the portion whereby the raised feature indicates and/or facilitates folding. The container as claimed in any of claims 2 to 8 wherein the electronic hardware component comprises an aperture for receiving the folded interface portion. The container as claimed in claim 9, wherein the aperture is wider than the combined width of the blister sheet and closure film. The container as claimed in any of claims 4 to 10, wherein the closure film and/or cover comprises visual indicators indicating times or the day and/or days of the week for each compartment. The container as claimed in any preceding claim, wherein the electronic hardware component can be programmed to detect when an electrically conductive circuit has been broken. The container as claimed in claim 12, wherein the detection of the breaking of an electrically conductive circuit can be communicated with a remote server. The container as claimed in claim 12, wherein the detection of the breaking of an electrically conductive circuit can be logged or communicated to a user. The container as claimed in either claim 13 or 14, wherein the electronic hardware component comprises a user interface. The contained as claimed in claim 15, wherein the user interface comprises a visual display unit. The container as claimed in any preceding claim, wherein each compartment contains one or more doses of one or more medicaments. The container as claimed in any preceding claim, wherein the medicaments are in the form of a tablet, pill or lozenge. The container as claimed in any preceding claim, wherein the flexible film adheres to the blister sheet using an adhesive layer located on either the blister sheet or the flexible film. The container as claimed in claim 19, wherein an adhesive is covered by a backing material so as to protect the adhesive prior to the closure film being adhered to the blister sheet. The container as claimed in any preceding claim, wherein the container is in a kit form, which is assembled after an individual’s medicaments have been inserted into the compartments. The container as claimed in any one of claims 4 to 21 , wherein the cover forms a wallet. The container as claimed in any preceding claim, wherein the blister sheet has a thickness of between about 180 mu and about 1800 mu. A kit of parts for forming a medicine container for containing and indicating a medicine regime, the kit comprising: a blister sheet formed of a substantially planar substrate having a plurality of compartments for receiving one or more medicinal products and a foldable interface portion for being received in or on an electrical hardware component; a flexible closure film for adhering to the blister sheet and sealing over the compartments, wherein the closure film has a plurality of removable portions defined by a frangible outline which is crossed by a plurality of parallel electrically conductive circuits, each of said removable portions being alignable with each compartment and one or more electrically conductive circuits extending to and alignable with the interface portion and; an electronic hardware component which is adapted to receive the foldable interface portion when in a folded configuration so as to enable electrical contact of the one or more electrically conductive circuits with electrical connectors of the electronic hardware component and wherein the folded interface portion urges the one or more electrically conductive circuits against the electrical connectors of the electronic hardware component. The kit of parts as claimed in claim 24, wherein the kit comprises a container as claimed in any one of claims 1 to 23. A method of forming a medicine container for containing and indicating a medicine regime comprising; providing a blister sheet formed of a substantially planar substrate having a plurality of compartments for receiving one or more medicinal products and an interface portion for being received in or on an electrical hardware component; providing a flexible closure film for adhering to the blister sheet and sealing over the compartments, wherein the closure film has a plurality of removable or pierceable portions defined by a frangible outline which is crossed by a plurality of parallel electrically conductive circuits, each of said removable or pierceable portions being alignable with each compartment and one or more electrically conductive circuits extending to and alignable with the interface portion; providing an electronic hardware component which is adapted to receive the foldable interface portion so as to enable electrical contact of the one or more electrically conductive circuits with electrical connectors of the electronic hardware component and wherein the interface portion and/or the electrical hardware component is configured so as to urge the one or more electrically conductive circuits together with the electrical connectors of the electronic hardware component; filling the compartments of the blister sheet with one or more medicinal products; adhering the flexible closure film over the compartments such that the removable or pierceable portions are aligned with each compartment and interface portion; bringing the interface portion of the of the blister sheet in contact with the one or more electrically conductive circuits of the interface portion so that the electronically conductive circuits are in contact with, and urged together with the electrical connectors of the electronic hardware component. The method as claimed in claim 26, wherein the interface portion is foldable and the method comprises folding the interface portion before bring together the interface portion and the one or more electrically conductive circuits of the interface portion, and wherein the one or more electrically conductive circuits of the interface portion are housed within a aperture of the electronic hardware component and the substrate and blister sheet are deformable so as allow folding of the interface portion whilst retaining a degree of resilience when folded so as to urge the electrically conductive circuits together with the electrical connectors of the electronic hardware component when received in the aperture. The method as claimed in either claim 26 or 27, wherein the method is used to form a container as claimed in any one of claims 1 to 23.