Electronic Monitoring Device for Use with Blister Packs

FIELD OF THE INVENTION

The invention relates to devices for use with blister packs. Consumer products are packaged in blister packs with a tray into which is formed a plurality of discrete cavities and which is closed by a seal. The term consumer products is intended to cover a wide variety of products as illustrated by the following (non-exhaustive) list: foods, either for immediate consumption, pre-cooked, prepared or oven ready, including prepared meals, confectionary, hardware and DIY items, cosmetics, seeds, animal and fish feeds, electronic components, medical appliances and dressings, medicines and medication such as pills, tablets and capsules.

The blister packs may be used for organising and storing mixed medication for subsequent dispensation according to a pre-defined dosage regimen. The principle behind such mixed medication containers is that a dosage regimen of mixed medication can be organised in advance for a period of a week or more, and a patient or care-giver can then remove from the container, at pre-defined times over the said period, the one or more pills, tablets and/or capsules to be administered on each occasion according to the dosage regimen.

BACKGROUND ART

Blister packs are of course well known for the storage and dispensing of pills, tablets and capsules, which are stored in cavities in a multi-cavity tray and removed by pushing each pill, tablet or capsule through a rupturable film or foil covering the cavities. Such blister packs normally carry only one unit dose of the same medication in each cavity but can also be filled with a mixture of medications. Typically, for mixed medication, a tray may have a 2×7, 3×7, 4×7 or 5×7 array of cavities corresponding to 2, 3, 4 or 5 predefined medication times per day over a 7-day period, or one dose prescribed per day over a 2, 3, 4 or 5 week period. For example, a 4×7 tray may be filled with the medication to be taken at breakfast-time, lunchtime, early evening and immediately before retiring each day for a week, and then the filled cavities sealed with a rupturable or sequentially rupturable film or foil cover.

It is known to monitor dosage compliance by detecting when the contents of a particular cavity of a blister pack or multi-dosage dispensing container are dispensed, e.g. by pushing the contents through a rupturable seal or, in the case where the seal has a removable portion per cavity, by removing a removable portion to create an opening in the seal through which the contents of the cavity can be dispensed. For example, a pattern or array of electrically conductive tracks can be provided on the seal which are broken when the contents of a cavity are dispensed. An electronic module can be programmed with a particular dosage regimen (i.e. time information for when certain medication should be dispensed by the patient or care-giver) and can monitor the integrity of the electrically conductive tracks to determine if the medication is being dispensed properly. The programmed dosage regimen information can also be used to notify or alert the patient or care-giver at the times when the medication should be taken, and even to help the patient or care-giver identify the particular cavity whose contents should be dispensed, e.g. by providing a visual indicator. If the cavities are filled with consumer products other than medication then time information can be provided for when the contents of a particular cavity should, or should not, be dispensed. This can be used for security, tamper detection or stock control purposes, for example.

SUMMARY OF THE INVENTION

The present invention provides a device for use with a blister pack, a dispensing container, or a multi-dosage dispensing container (hereinafter referred to as ‘blister packs’) having a tray with one or more discrete cavities for receiving consumer products and a seal adhered to the tray to seal the one or more discrete cavities. The seal has a pattern of electrically conductive tracks that defines a circuit per cavity. The device itself comprises a holder for supporting the blister pack in use and an electronic module for monitoring the integrity of the circuits for dosage compliance, security, tamper detection or stock control purposes etc.

It will be readily appreciated that the blister pack does not form part of the present invention. The blister pack can have any suitable number of discrete cavities arranged in any suitable array, e.g. a 2×7, 3×7, 4×7 or 5×7 array of cavities. The holder will typically be provided with a matching construction as described in more detail below. Each different type of blister pack will typically require its own particular type of holder and in one arrangement of the present invention different holders can be used with the same electronic module. In one arrangement, the electronic module can also be used with blister packs that are not physically supported by a holder. In other words, although the electronic module will typically be particularly adapted for use with a holder that supports the blister pack, in one arrangement it can also be used without such a holder in certain circumstances.

The seal of the blister pack can have any suitable single- or multi-layer construction and can be rupturable or non-rupturable, i.e. with a removable portion per cavity. The pattern of electrically conductive tracks may be applied or integrated into the seal using any suitable technique. However, one preferred option is to print the electrically conductive tracks onto a surface of the seal using conductive ink. In the case of a rupturable seal, each circuit is aligned with an associated discrete cavity such that a circuit is broken when the contents of the aligned cavity are pushed through the rupturable seal and this is recorded by the electronic module. In the case of a non-rupturable seal, the seal can include pre-formed lines of separation that define a removable portion per cavity to retain the consumer products in that cavity until it is removed along its line of separation. Each removable portion can be attached to the remainder of the seal by a frangible bridge region defined by a gap in the associated pre-formed line of separation and which provides a pathway for the associated circuit. The frangible bridge region is designed to tear when the associated removable portion is released or removed from the remainder of the seal along its line of separation. Tearing the frangible bridge region breaks the associated circuit that runs along the frangible bridge region (i.e. along the pathway defined by the gap) and this is recorded by the electronic module. Each removable portion can include a lug portion that can be grasped by a user preparatory to removing the removable portion.

The present invention further provides an electronic module adapted to be releasably connected to a holder that supports a blister pack as described above (wherein the holder optionally includes a dispensing chamber and is adapted to support the blister pack in use with the open mouth of each cavity of a supported blister pack facing the dispensing chamber such that when the contents of a cavity are dispensed through the seal they are received in the dispensing chamber); and

- wherein the electronic module includes electronic monitoring means for monitoring each circuit when the holder is connected to the electronic module in use and when part of the blister pack that includes a termination point for each circuit is in electrical contact with the electronic monitoring means.

A generally planar surface of the holder can include a shallow recess for receiving the blister pack. The blister pack is physically supported by the holder in use. The holder can include one or more openings or apertures in register with the one or more discrete cavities of the blister pack that is to be supported by the holder. In one arrangement the holder can be a simple sheet (e.g. of plastics material) of suitable thickness in which the one or more openings are provided. The blister pack can be positioned on the holder such that the open mouth of each discrete cavity is facing an associated opening or aperture, i.e. such that the discrete cavities are facing away from the holder and are freely accessible to the user. When the content of a cavity is dispensed by pressing down on the cavity the consumer product(s) pass through the associated opening or aperture in the holder, optionally passing into an underlying open recess or dispensing chamber defined by the holder. If the holder includes a dispensing chamber, the dispensed contents of the cavity may optionally be dispensed into a suitable receptacle by tilting the holder such that the contents fall out of the dispensing chamber through an opening in an end of the holder.

The holder can be made child-resistant. This is particularly important if the consumer products include medication. The holder can include a blocking means (or child safety mechanism) that is typically slidably movable along an axis of the holder (e.g. a longitudinal axis) or rotatable between a closed position where the blocking means covers each opening or aperture in the holder, and an open position. When the blocking means is in the open position, each opening or aperture in the holder is typically in open communication with the dispensing chamber or open recess. When the blocking means is in the closed position, the contents of a discrete cavity cannot be properly dispensed and are retained in the discrete cavity or the corresponding opening or aperture in the holder by the blocking means which is typically positioned between the corresponding opening or aperture and the dispensing chamber or open recess. However, the blocking means can also be provided between the corresponding opening or aperture in the holder and the seal of the blister pack.

The blocking means can include one or more openings that are in register with the one or more openings in the holder when the blocking means is in the open position. User-operable locking means can be provided on the holder for selectively retaining the blocking means in the closed position. In other words, the user-operable locking means must be operated or manipulated by a user before the blocking means can be moved to the open position. The user-operable locking means is preferably child-resistant, i.e. it is designed such that it cannot be physically operated or manipulated by a child. This ensures that the blocking means can only be moved from the closed position to the open position by an adult user.

The blocking means can be slidable within the dispensing chamber or open recess of the holder.

If the holder further includes user-operable retaining means or locking means for retaining a hinged lid in a closed position (see below) then the operation of the retaining means or locking means may be coordinated with the blocking means, e.g. such that the retaining means or hinged lid can only be moved from the closed position to the open position after the blocking means has been moved to the open position by operating or manipulating the user-operable locking means. This provides a further child-resistant feature because it prevents the blister pack from being removed from the holder by a child.

The blister pack can be supported by the holder with its seal in direct contact with a generally planar surface of the holder.

One or both of the holder and the blister pack can have alignment features for ensuring that they are properly aligned in use.

The holder will typically include an array of openings or apertures that corresponds to an array of discrete cavities.

The holder can further include a hinged lid having one or more openings or apertures, each opening being shaped and sized to receive a corresponding discrete cavity of the blister pack or dispensing container in use. The lid will typically include an array of openings or apertures that corresponds to an array of discrete cavities. The supported blister pack can be positioned securely between a generally planar surface of the holder and the lid when the lid is in a closed position. In this closed position each cavity will protrude through an associated opening or aperture in the lid so that it remains accessible to the user. An array of discrete cavities may be received in a single opening or aperture provided in the lid. In other words, it is not necessary for each discrete cavity to have a corresponding opening or aperture in the lid. The lid can be moved to an open position which allows the blister pack or dispensing container to be inserted into the holder, or removed from, the holder. When the lid is in the closed position, the openings or apertures in the lid are typically in register with the openings or apertures in the generally planar surface of the holder.

The lid can be selectively secured in the closed position. For example, suitable friction or press-fit features can be provided that engage when the lid is closed and which can be disengaged by the user when the lid needs to be opened so that a blister pack can be inserted, or a previously inserted blister pack can be removed. User-operable locking means for selectively securing the lid in a closed position can also be provided.

The lid and the main body of the holder can be separately or integrally formed.

If the holder does not include a lid then it can include at least one slot or recess for retaining a respective edge part of the blister pack in use. If the holder includes a slot or recess for retaining an edge part of the blister pack (or a pair of slots or recesses for retaining opposite edge parts) then the tray of the blister pack may need to be flexed or bent slightly when it is inserted and/or removed.

Other ways of releasably retaining the blister pack on the holder can be provided. For example, the holder can include user-operable retaining means, optionally being slidable along an axis of the holder (e.g. a transverse axis) or rotatable between a closed position where the retaining means defines part of a slot or recess for retaining an edge part of the blister pack in use, or which otherwise retains the blister pack in position and prevents its removal, and an open position. In some arrangements the blister pack need not be releasably retained and can, for example, simply sit in a shallow recess provided in a generally planar surface of the holder.

The holder can be made of any suitable material (e.g. a plastics material) and can include sidewalls that define the periphery of a dispensing chamber or open recess.

In one arrangement a dispensing chamber can include one or more channels. More particularly, one or more walls can be used to divide the dispensing chamber into separate channels. The channels will typically be shaped and sized to correspond with the layout of the blister cavities, i.e. so that each channel is aligned with a row of cavities. End channels may be defined between a wall and a sidewall of the housing that defines the periphery of the dispensing chamber.

At least one end of each channel can be open or include an opening so that the dispensed contents of a cavity can be removed from the holder. For example, once the contents of discrete cavity have been dispensed into a channel of the dispensing chamber, the holder can be tilted so that the dispensed consumer products fall out of the channel into a suitable receptacle.

In one arrangement, a user can push down on a particular cavity to push the contents of the cavity through the rupturable or non-rupturable seal. In the case of a non-rupturable seal then the seal will preferably separate along the pre-formed lines of separation (e.g. tear lines, perforations or cut lines) when the user pushes down on the discrete cavity and the contents will be dispensed through the opening that is created when the removable portion is separated from the remainder of the seal. As described above, the contents of the cavity can optionally pass through an aligned opening or aperture in the holder and into an open recess or a dispensing chamber from which they can be removed by a user.

In one arrangement, the blister pack can be positioned on the holder such that the holder is adapted to support the blister pack with the open mouth of each discrete cavity facing away from a generally planar surface of the holder, i.e. such that the seal is freely accessible to the user, and the holder includes one or more openings, apertures or chambers for receiving the one or more discrete cavities of the blister pack. An array of discrete cavities may be received in a single opening, aperture or chamber provided in the holder. Alternatively, each discrete cavity can be received in an associated opening, aperture or chamber. This arrangement is useful if each removable portion of the seal includes a lug portion that can be grasped by a user preparatory to removing a removable portion so that the contents of the underlying cavity can be dispensed through the newly created opening in the seal.

Such a holder can also be made child-resistant. The holder can include a blocking means (or child safety mechanism) that is typically slidably movable along an axis of the holder (e.g. a longitudinal axis) or rotatable between a closed position where the blocking means covers one or more removable portions of the seal corresponding to each discrete cavity of the blister pack, and an open position where each removable portion is accessible. The blocking means can include one or more openings that are in register with the one or more removable portions of the seal when the blocking means is in the open position. User-operable locking means can be provided on the holder for selectively retaining the blocking means in the closed position. The user-operable locking means is preferably child-resistant as described above.

The holder can further include a hinged lid such that the supported blister pack can be positioned securely between a generally planar surface of the holder and the lid when the lid is in a closed position. The lid can include an array of openings or apertures that corresponds to an array of discrete cavities. Access to each removable portion of the seal can be provided through an associated opening or aperture in the lid. An array of removable portions may be accessed through a single opening or aperture provided in the lid. Alternatively, the lid can be provided without an array of openings or apertures in which case the lid must be opened to allow access to the seal of the supported blister pack. The lid can be moved to an open position which allows the blister pack or dispensing container to be inserted into the holder, or removed from, the holder.

The lid and the main body of the holder can be separately or integrally formed.

If the holder further includes user-operable retaining means or locking means for retaining a hinged lid in a closed position (see above) then the operation of the retaining means or locking means may be coordinated with the optional blocking means, e.g. such that the retaining means or hinged lid can only be moved from the closed position to the open position after the blocking means has been moved to the open position by operating or manipulating the user-operable locking means.

The electronic module typically includes a slot in an outer housing of single- or multi-part construction into which an edge part of the blister pack is inserted in use. The electronic module can further include user-operable locking means for selectively securing the blister pack within the slot. Such user-operable locking means can engage with locking features provided on the blister pack. The edge part of the blister pack that is inserted into the slot will include the above-mentioned termination points. Each circuit can include a pair of termination points that represent the start and end of the circuit. The electronic monitoring means can include any suitable contacts that are in electrical contact with the termination points so that the electronic monitoring module can determine and record when a particular circuit is broken. By monitoring when a particular circuit is broken, the electronic module can determine when the contents of a cavity have been dispensed and the time when that occurred. Recorded information can be stored within the electronic module (e.g. in a memory unit) or can be transmitted or uploaded to a remote device. For example, the electronic module can include a communication unit which allows information to be transmitted periodically or when a circuit is broken. Information can also be downloaded to the electronic module by the communication unit. The communication unit can utilise any suitable wireless communication, or can allow the electronic module to be physically connected to a remote device. For transmitting or receiving information the communication means can utilise any suitable wireless communication protocol such as GSM, BLUETOOTH or WIFI wireless connectivity. If the blister pack is used to store high value items then the electronic module may be used to check for tampering or the unauthorised access to the contents of the cavities, e.g. if a cavity is opened outside of an approved time window. If the blister pack is used to store medication then the electronic module may be used to check if the medication is being dispensed according to a prescribed dosage regimen, the details of which may be stored in the electronic module. In this way, the electronic module may provide “real time” monitoring of the dispensing of the blister pack contents. If the medication is not being dispensed according to the prescribed dosage regimen then the patient, care-giver or responsible medical professional may be alerted automatically, e.g. by SMS message sent by the electronic module or a remote device. The electronic module is preferably programmable and can store other information such as the contents of each cavity of the blister pack, patient information such as contact details, relevant medication information, prescribed dosage regimen etc. This information can be provided to the electronic module by the blister pack, e.g. when it is electrically connected to the electronic module or by any other suitable means such as radio-frequency identification (RFID) or near field communication (NFC). For example, the blister pack can include a RFID or NFC tag and the electronic module can include a corresponding RFID or NFC reader. For security and data protection purposes, a unique patient identification number and a blister pack identification number may be programmed into the electronic module which can then be referenced to the above-mentioned patient specific information via a secure server and database. This can ensure that only a particular blister pack is used with the electronic module.

The electronic module can be adapted to be releasably secured to the holder by any suitable means, e.g. releasable clips, catches or connectors, a shaped projection on one of the electronic module and the holder that is slidably received in a complimentary slot or channel on the other of the electronic module and the holder, mechanical fixings such as screws etc. The electronic module can further include user-operable locking means for selectively securing the electronic module to the holder.

The electronic module can include means for allowing it to be releasably secured to the rings of a ring binder.

The present invention further provides a holder that supports a blister pack as described above, wherein the holder is adapted to be releasably connected to an electronic module that includes electronic monitoring means for monitoring each circuit when the holder is connected to the electronic module in use and when part of the blister pack that includes a termination point for each circuit is in electrical contact with the electronic monitoring means (wherein the holder optionally includes a dispensing chamber and is adapted to support the blister pack in use with the open mouth of each cavity of a supported blister pack facing the dispensing chamber such that when the contents of a cavity are dispensed through the seal they are received in the dispensing chamber).

Further features of the holder are as described herein.

The holder can further include user-operable locking means for selectively securing the holder to the electronic module.

The present invention further provides a device for use with a blister pack as described above, the device comprising:

- a holder that supports the blister pack (wherein the holder optionally includes a dispensing chamber and is adapted to support the blister pack in use with the open mouth of each cavity of a supported blister pack facing the dispensing chamber such that when the contents of a cavity are dispensed through the seal they are received in the dispensing chamber); and
- an electronic module releasably connected to the holder, wherein the electronic module includes electronic monitoring means for monitoring each circuit when part of the blister pack that includes a termination point for each circuit is in electrical contact with the electronic monitoring means.

Further features of the holder and the electronic module are as described herein.

The present invention further provides a device for use with a blister pack as described above, the device comprising:

- a holder that supports the blister pack (wherein the holder optionally includes a dispensing chamber and is adapted to support the blister pack in use with the open mouth of each cavity of a supported blister pack facing the dispensing chamber such that when the contents of a cavity are dispensed through the seal they are received in the dispensing chamber); and
- an electronic module integral with the holder (i.e. integrally formed with the holder or separately formed and permanently connected or secured to the holder by any suitable means to define a singe-piece device assembly), wherein the electronic module includes electronic monitoring means for monitoring each circuit when part of the blister pack that includes a termination point for each circuit is in electrical contact with the electronic monitoring means.

In one arrangement the device can have a two-part construction with a first housing part that defines part of the holder (e.g. an upper part of the holder that physically supports the blister pack and which optionally includes the openings or apertures that are aligned with the open mouths of the discrete cavities of the blister pack) and the integral electronic module, and a second housing part that defines part of the holder (e.g. a lower part that includes an underlying open recess or dispensing chamber, or one or more openings, apertures or chambers for receiving the discrete cavities of the blister pack in an arrangement where the seal is accessible to the user). Together, the first and second housing parts define the holder and the integral electronic module, i.e. the device. The housing parts can be injection moulded from a suitable plastics material.

Further features of the holder and the electronic module are as described herein, with the exception of those features that allow the holder and the electronic module to be releasably connected together.

In use, a blister pack can be supported on the holder with the open mouth of each discrete cavity facing the holder and typically with the seal in direct contact with a generally planar surface of the holder in which an aligned opening or aperture is provided for each cavity. The blister pack can also be supported with each discrete cavity in an opening, aperture or chamber provided in the holder so that the seal is accessible to the user. The blister pack is also supported on the holder such that the termination points of the electrically conductive tracks can be monitored by the electronic monitoring means. In the case of a device where the holder and the electronic module are integrally formed, the blister pack is simply inserted into the device, typically such that the edge part that contains the termination points is received within the slot in the outer housing of the electronic module or device. Any lid or retaining means can be moved from the open position which allows the blister pack to be inserted into the device to the closed position to secure the blister pack in position relative to the holder. If the holder or outer housing includes a slot or recess for retaining an opposite edge part of the blister pack then the tray of the blister pack may need to be flexed or bent slightly when it is inserted into the device. In the case of a device where the holder and the electronic module are separately formed and are releasably connected together, the blister pack can be inserted into the holder before the holder is connected to the electronic module, typically in such a way that the edge part of the blister pack that contains the termination points is received within the slot in the outer housing of the electronic module. However, it is perhaps more likely that the holder and the electronic module will be connected together before the blister pack is inserted into the device as described above.

In one arrangement where the discrete cavities are accessible, the user can push down on the supported blister pack tray to push the contents of a particular cavity through the rupturable or non-rupturable seal. In the case of a non-rupturable seal, the seal will separate along the pre-formed lines of separation (e.g. tear lines, perforations or cut lines) and the contents will be dispensed through the opening that is created when the removable portion is separated from the remainder of the seal. The contents of the cavity can pass through the aligned opening or aperture in the generally planar surface of the holder and into an optional dispensing chamber or open recess from which they can be removed from the holder, e.g. by tilting the device so that the consumer products fall out of the open end of the channel, or an open recess. In one arrangement where the seals are accessible, the user can remove one of the removable portions of the seal, e.g. by grasping a lug portion, so that the contents of the associated discrete cavity can be dispensed.

The electronic module will monitor when the contents of each cavity are dispensed, e.g. for compliance with a prescribed dosage regimen.

DRAWINGS

FIG. 1 is a top view of a device according to a first embodiment of the present invention;

FIG. 2 is a cross-section view along line A-A of FIG. 1;

FIG. 3 is a cross-section view with the holder and electronic module separated;

FIG. 4 is a cross-section view of a device according to a second embodiment of the present invention;

FIG. 5 is a top view of a blister pack;

FIG. 6 is a cross-section view along the line B-B of FIG. 5;

FIG. 7 is a top view of a device according to a third embodiment of the present invention;

FIG. 8 is a cross-section view along the line C-C of FIG. 7;

FIG. 9 is a top view of the device of FIG. 7 showing a child safety mechanism in an open position;

FIG. 10 is a cross-section view along line D-D of FIG. 9;

FIG. 11 is a top view of the device of FIG. 7 with the blister pack removed and showing the child safety mechanism in a closed position;

FIG. 12 is a top view of the device of FIG. 7 with the blister pack removed and showing the child safety mechanism in an open position;

FIG. 13 is a top view of a device according to a fourth embodiment of the present invention with a retaining mechanism;

FIG. 14 is a cross-section view along the line E-E of FIG. 13 with a retaining mechanism in a closed position;

FIG. 15 is a cross-section view of the device of FIG. 13 showing the insertion of a blister pack with a retaining mechanism in an open position;

FIG. 16 is a top view of part of the child safety mechanism;

FIGS. 17 and 18 are cross-sectional views showing different types of child safety mechanism;

FIG. 19 is a top view of a device according to a fifth embodiment of the present invention;

FIG. 20 is a cross-section view along line F-F of FIG. 19;

FIG. 21 is a top view of the device of FIG. 19 showing a child safety mechanism in an open position;

FIG. 22 is a cross-section view along line G-G of FIG. 21;

FIG. 23 is a top view of a device according to a sixth embodiment of the present invention;

FIG. 24 is a cross-section view along line H-H of FIG. 23;

FIG. 25 is a top view of the device of FIG. 23 showing a child safety mechanism in an open position;

FIG. 26 is a cross-section view along line I-I of FIG. 25;

FIG. 27 is a top view of a device according to a seventh embodiment of the present invention; and

FIG. 28 is a cross-section view along line J-J of FIG. 27.

Although the device according to the present invention can be used with a blister pack containing a wide range of consumer products, the rest of the specification will concentrate mainly on a blister pack for storing medication that is intended to be dispensed according to a predefined dosage regimen.

With reference to FIGS. 5 and 6 a blister pack 40 includes a tray 42 made of a plastics material into which is formed a 2×7 array of discrete cavities 44. The cavities 44 are closed by a seal 46 which is adhered to a generally planar top surface of the tray 42. Each cavity 44 contains medication in the form of one or more pills, tablets and capsules. The blister pack 40 can carry only one unit dose of the same medication in each cavity or can also be filled with a mixture of medications.

A pattern of electrically conductive tracks (not shown) are printed onto a surface of the seal 46 to define a circuit for each of the cavities 44. Each circuit extends over a part of the seal that is aligned with an associated cavity 44 so that it is broken when the contents of the cavity are dispensed through the seal 46.

An edge part 48 of the seal 46 includes a series of termination points 50 that represent the start and end points of each circuit.

A device 1A according to a first embodiment is shown in FIGS. 1 to 3.

The device 1A includes a holder 2 adapted to support the blister pack 40. The holder 2 includes a base 4 and a lid 6 joined together by an integral hinge 8.

The lid 6 includes a peripheral flange 10 and is formed with a 2×7 array of openings 12 that are shaped and sized to receive the cavities 44 of the blister pack 40.

The base 4 includes sidewalls 14 extending between a bottom wall 16 and a top wall 18 to define the periphery of a dispensing chamber. The dispensing chamber is divided into two channels 20, 22 by a wall 24.

The channels 20, 22 are aligned with the openings 12 in the lid 6 when the lid is in a closed position as shown in FIGS. 1 to 3. The top wall 18 of the base 4 also has a 2×7 array of openings 26 that are aligned with the openings 12. The openings 26 provide access to the channels 20, 22 through the top wall 18 of the base 4.

It will be readily appreciated that the holder is specifically adapted for use with the blister pack shown in FIGS. 5 and 6 with a 2×7 array of cavities 44. Different types of blister pack require different holders. For example, if the blister pack has a 4×7 array of cavities then the holder would have a corresponding 4×7 array of openings in the lid, a corresponding 4×7 array of openings in its top surface, and four channels arranged side by side in its base. An electronic module 30 will be capable of being used with different types of holder and blister pack. In other words, all of the different types of holder will have the same connection feature so that they can be releasably connected to the electronic module and all of the different blister packs will be compatible with the electronic module when supported by the holder, e.g. have a compatible series or arrangement of termination points that can be monitored by the electronic module. If the electronic module includes user-operable locking means for retaining the blister pack in the slot then all compatible blister packs will be provided with compatible locking features if appropriate. The electronic module can also be connected to other types of blister pack or dispending containers that are designed to be used without a holder. Such an electronic module would still include the connection features necessary to allow it to be releasably connected to a holder and so would fall within the scope of the present invention.

At least one end of each channel 20, 22 is open.

The bottom wall 16 of the holder 2 includes an outwardly projecting part or flange 28 that is adapted to allow the holder to be releasably connected to an electronic module 30.

The electronic module 30 includes an outer housing 32 of single- or multi-part construction that encloses suitable circuitry components such as a power source (e.g. a battery), a microprocessor or similar device for monitoring the individual circuits, a memory for recording and storing information, and optionally a communication unit to allow information to be uploaded to or downloaded from a remote device. The electronic module 30 can be programmed with patient details, relevant medical information and the prescribed dosage regimen—i.e. information about when the medication stored in each cavity of the blister pack should be dispensed. The programming can be done by wireless communication or by a wired connection to a remote device or the blister pack. For security and data protection purposes, a unique patient identification number and a blister pack identification number may be programmed into the electronic module which can then be referenced to the above-mentioned patient-specific information via a secure server and database.

As described in more detail below, when the holder 2 is connected to the electronic module 30 in use, the edge part 48 of the blister pack 40 on which the termination points 50 are provided is received in a slot 34 on the side of the outer housing 32. The blister pack 40 can be selectively retained in position within the slot by user-operable locking means (not shown) or other suitable locking or engagement features. The electronic module 30 can include terminals which are in electrical contact with the termination points 50 when the blister pack 40 is inserted properly into the slot 34.

The outer housing 32 is adapted to allow the electronic module 30 to be releasably connected to the flange 28 of the holder 2. It will be readily appreciated that one or both of the flange 28 and the outer housing 32 can be provided with any suitable connection feature to facilitate this. For example, the electronic module 30 and the holder 2 can be releasably secured together using releasable clips, catches or connectors, a shaped projection on one of the flange 28 and the outer housing 32 that is received in a complimentary slot or channel on the other of the flange and the outer housing, mechanical fixings such as screws etc. Although in the first embodiment the connection feature is provided on the flange 28 and the bottom surface of the outer housing 32, it will also be readily appreciated that alternative or additional connection features can also be provided on the side surface 32a of the outer housing 32 (i.e. below the slot 34) and the facing side surface 4a of the base 4.

To use the device 1, the holder 2 is connected to the electronic module 30. FIG. 3 shows the electronic module 30 and the holder 2 as separate components before they are releasably connected together. The lid 6 is moved to an open position and the blister pack 40 is installed to the holder 2 by inserting the edge part 48 of the blister pack tray into the slot 34 in the outer housing 32 and positioning the blister pack on the generally planar top surface 18 of the base 4 with the open mouth of each cavity 44 facing an opening 26 in the top surface. The lid 6 can then be moved to the closed position shown in FIGS. 1 to 3 so that the cavities 44 are received through the openings 12 in the lid. The blister pack 40 is therefore positioned securely between the top surface 18 of the base 4 and the lid 6. The openings 12 in the lid 6 also ensure that the blister pack 40 is properly aligned relative to the base 4 of the holder 2. It is also possible for the blister pack 40 to be inserted into the holder 2 before the holder is connected to the electronic module 30.

The medication stored in the cavities 44 of the blister pack can be dispensed by pushing the medication through the seal 46 from above. Any medication that is pushed through the seal will pass through the corresponding opening 26 in the base 4 and will fall into the underlying channel 20, 22. If the device 1A is angled or tilted then the medication will slide out of the open end of the channel into the user's hand or a suitable receptacle.

Pushing the medication through the seal 46 breaks the circuit that is associated with the particular cavity 44. The break in the circuit is detected by the microprocessor of the electronic module 30. The microprocessor can record which circuit is broken and the time when the contents were dispensed. This can be compared against a stored prescribed dosage regimen to ensure dosage compliance. If the prescribed dosage regimen indicates that a medication has not been properly dispensed (e.g. the circuit has not been broken within the correct time range or an incorrect circuit has been broken) then the electronic module 30 or a remote device can send an alert or warning. The electronic module 30 or a remote device can also remind the user when the contents of a particular cavity need to be dispensed, optionally this can be achieved by means of an SMS message or a visual or audible alert.

A device 1B according to a second embodiment is shown in FIG. 4. The device 1B is similar to the device 1A shown in FIGS. 1 to 3 and like components have been given the same reference numeral. In this case the holder 2B does not include a lid and the base 4B includes a hook part 36 that defines a channel into which an opposite edge part of the blister pack can be clipped. In practice, the edge part 48 is inserted into the slot 34 in the outer housing 32 and the blister pack tray is then flexed or bent slightly so that the opposite edge part 52 can be inserted underneath the hook part 36. Other ways of securely supporting the blister pack on the holder can be used.

A device 1C according to a third embodiment is shown in FIGS. 7 to 12. The device 1C is operated in a similar manner to the devices 1A and 1B shown in FIGS. 1 to 4 but the holder and electronic module are not releasably connected together.

The device 1C includes a two-part outer housing 54. An upper part 56 of the outer housing 54 defines a holder and includes a generally planar surface 58 that is adapted to support a blister pack 40 as described above. An electronic module 60 forms an integral part of the upper part 56 of the outer housing 54. The upper part 56 of the outer housing includes a peripheral flange 62 and is formed with a 2×7 array of openings 64 that are aligned with the cavities 44 of the blister pack 40.

A lower part (or base) 66 of the outer housing 54 defines the periphery of a dispensing chamber 68.

A child safety mechanism 70 is located within the dispensing chamber 68 and can slide backwards and forwards in a direction parallel with a longitudinal axis of the dispensing chamber. The child safety mechanism 70 is shown in more detail in FIGS. 16 and 17 and includes a top part 72 with an array of openings 74 and sidewalls 76. An alterative child safety mechanism 78 is shown in FIG. 18 and includes a top part 80 with an array of openings, sidewalls 82, and an intermediate wall 84 which divides the dispensing chamber into a pair of channels 86a, 86b. The array of openings 74 in the top part 72 of the child safety 70 carrier are aligned with the openings 64 in the upper part 56 of the outer housing 54 when the child safety mechanism is in an open position shown in FIGS. 9, 10 and 12, i.e. where it has been moved relative to the outer housing 54 such that the child safety mechanism extends beyond the upper part of the housing. When the child safety mechanism 70 is in a closed position shown in FIGS. 7, 8 and 11, the openings 74 in the top part 72 of the child safety mechanism are not aligned with the openings 64 in the upper part 56 of the outer housing 54 so the latter openings are effectively blocked by the top part of the child safety mechanism (i.e. by the remainder of the top part between the openings 74). Only when the child safety mechanism 70 is moved to the open position can the contents of a discrete cavity 44 of the blister pack 40 be pushed through the opening 64 and into the dispensing chamber 68 beneath.

It will be readily appreciated that in FIGS. 11 and 12 the blister pack 40 has been removed so that the child safety mechanism is more clearly visible through the openings 64 in the upper part of the outer housing 54.

To enable the child safety mechanism 70 to slide longitudinally within the dispensing chamber 68, the user must first release carrier locking features (not shown) in the sides of the device 1C. Unless the carrier locking features are released, as indicated by the arrows in FIGS. 7 and 11, the child safety mechanism 70 will remain in the closed position where it covers the openings 64 in the upper part 56 of the outer housing 54 so that medication cannot be dispensed from the device through the dispensing chamber 68. The child safety mechanism 70 can include a part which can be easily grasped by the user preparatory to moving the child safety mechanism to the open position. Typically, the carrier locking features will be released with one hand while the child safety mechanism 70 is moved to the open position (i.e. the limit of its travel) with the other hand at the same time.

The electronic module 60 within the outer housing 54 includes suitable circuitry components such as a power source (e.g. a battery), a microprocessor or similar device for monitoring the individual circuits, a memory for recording and storing information, and optionally a communication unit to allow information to be uploaded to or downloaded from a remote device. The electronic module 60 can be programmed with patient details, relevant medical information and the prescribed dosage regimen—i.e. information about when the medication stored in each cavity of the blister pack should be dispensed. The programming can be done by wireless communication or by a wired connection to a remote device or the blister pack. For security and data protection purposes, a unique patient identification number and a blister pack identification number may be programmed into the electronic module which can then be referenced to the above-mentioned patient-specific information via a secure server and database.

The edge part 48 of the blister pack 40 is received in a slot 88 in the outer housing 54, or more particularly in the upper part 56. The blister pack 40 can be selectively retained in position within the slot 88 by user-operable locking means (not shown) or other suitable locking or engagement features. The electronic module 60 can include terminals which are in electrical contact with the termination points 50 when the blister pack 40 is inserted properly into the slot 88.

A device 1D according to a fourth embodiment is shown in FIGS. 13 to 15. The device 1D is similar to the device 1C shown in FIGS. 7 to 12 and like parts have been given the same reference numeral.

The lower part 66 of the outer housing 54 includes a retaining mechanism 90 which can be moved backwards and forwards in a direction parallel with a transverse axis of the device. The retaining mechanism 90 includes a lower part 92, a side part 94 and a hook part 96. When the retaining mechanism 90 is in a closed position shown in FIGS. 13 and 14, the hook part 96 extends over the adjacent peripheral flange 62 and slightly over the shallow recess into which the blister pack 40 is received in use. When the retaining mechanism 90 is in an open position shown in FIG. 15, the hook part 96 does not extend over the shallow recess and is spaced away from the adjacent peripheral flange 62.

FIG. 15 shows how a blister pack 40 can be inserted into the device 1D when the retaining mechanism 90 is in the open position.

When the retaining mechanism 90 is in the closed position, the child safety mechanism 70 can be operated as described above.

Typically, the retaining mechanism 90 can only be moved from the closed position to the open position after the child safety mechanism 70 has been moved to the open position. This requires the carrier locking features (not shown) to be released. Once a blister pack 40 has been inserted into the device 1D, the retaining mechanism 90 is moved to the closed position and the child safety mechanism 70 is moved to a closed (and locked) position to maintain the retaining mechanism in the closed position where the blister pack cannot be removed.

A device 1E according to a fifth embodiment is shown in FIGS. 19 to 22. The device 1C includes a two-part outer housing 98. An electronic module 100 forms an integral part of an upper part 102 of the outer housing 98. A lower part 104 of the outer housing 98 includes a hook flange 106 for retaining an edge part of the blister pack 40. The holder which physically supports the blister pack 40 is defined by the upper and lower parts 102, 104 of the outer housing 98. The blister pack is in direct contact with a generally planar surface defined by a lower surface 114a of a slot 114 in the upper part 102 of the outer housing 98 and a corresponding surface 104a of the lower part 104 of the outer housing.

In the devices 1A to 1D described above, the blister pack 40 is inserted such that the cavities 44 are accessible to the user. In device 1E the blister pack 40 is inserted such that the cavities 44 are located in a chamber 108 defined mainly by the lower part 104 of the outer housing 98. The device 1E is therefore suitable for use with blister packs where the seal 46 is a non-rupturable seal provided with removable portions that optionally include lug portions that can be grasped by a user preparatory to removing the associated removable portion from the remainder of the seal so that the contents of the underlying cavity can be dispensed through the newly created opening in the seal.

A child safety mechanism 110 is located adjacent the seal of the blister pack 40 and is retained in position by the hook flange 106 and a first slot 112 provided in the upper part 102 of the outer housing 98. The blister pack 40 is positioned between the child safety mechanism 110 and the two-part outer housing 98 and an edge part 48 of the blister pack is received in the slot 114 provided in the upper part 102 of the outer housing.

The child safety mechanism 110 can slide backwards and forwards in a direction parallel with a longitudinal axis of the device 1E. The child safety mechanism 110 includes an array of openings 116 that are aligned with the open mouths of the discrete cavities 44, and therefore with the removable portions of the seal, when the child safety mechanism is in an open position shown in FIGS. 21 and 22, i.e. where it has been moved relative to the outer housing 98 such that the child safety mechanism extends beyond the upper part of the outer housing. When the child safety mechanism 110 is in a closed position shown in FIGS. 19 and 20, the openings 116 in the child safety mechanism are not aligned with the open mouths of the discrete cavities 44 so the removable portions of the seal are effectively blocked or covered by the child safety mechanism and cannot be accessed by a user. Only when the child safety mechanism 110 is moved to the open position can a removable portion of the seal be properly accessed so that it can be removed to allow the contents of the underlying discrete cavity 44 to be dispensed through the newly created opening in the seal.

To enable the child safety mechanism 110 to slide longitudinally, the user must first release carrier locking features (not shown) in the sides of the device 1E. Unless the carrier locking features are released, as indicated by the arrows in FIG. 19, the child safety mechanism 110 will remain in the closed position where it covers the removable portions of the seal. The child safety mechanism 110 can include a part which can be easily grasped by the user preparatory to moving the child safety mechanism to the open position. Typically, the carrier locking features will be released with one hand while the child safety mechanism 110 is moved to the open position (i.e. the limit of its travel) with the other hand at the same time.

The electronic module 100 is similar to the electronic module 60 described above and operates in a similar manner. In particular, the electronic module 100 can include terminals which are in electrical contact with the termination points 50 when the blister pack 40 is inserted properly into the slot 114. The retaining mechanism described above for device 1D could also be used with this particular device.

A device 1F according to a sixth embodiment is shown in FIGS. 23 to 26. The device 1F is similar to the device 1E shown in FIGS. 19 to 22 and like parts have been given the same reference numeral.

The device 1F includes carrier locking features 118a, 118b provided in the upper part 102 of the outer housing 98. To enable the child safety mechanism 110 to slide longitudinally the user must first release carrier locking features 118a, 118b by moving them towards each other as indicated by the arrows in FIG. 23. Unless the carrier locking features 118a, 118b are released, the child safety mechanism 110 will remain in the closed position where it covers the removable portions of the seal so that medication cannot be dispensed from the discrete cavities 44. The carrier locking features 118a, 118b can be used with any of the other devices 1C to 1E described above.

A device 1G according to a seventh embodiment is shown in FIGS. 27 and 28 The device 1G is similar to the device 1C shown in FIGS. 7 to 12 and like parts have been given the same reference numeral.

The device 1G includes an alternative lower part 66G which includes an open recess 68G instead of a dispensing chamber 68. The child safety mechanism 70 is located within the open recess 68G and slides backwards and forwards in a direction parallel with a longitudinal axis of the open recess. Otherwise, the child safety mechanism 70 operates in the same way as described above. The retaining mechanism of device 1D and/or the alternative carrier release feature of device 1F can be used with a lower part that includes an open recess.

Electronic Monitoring Device for Use with Blister Packs

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