GB2558573A

GB2558573A - Improvements in or relating to a medicament dispenser

Info

Publication number: GB2558573A
Application number: GB1700159.5A
Authority: GB
Inventors: Ali Moiyed Taher
Original assignee: Aerobit Health Ltd
Current assignee: Aerobit Health Ltd
Priority date: 2017-01-05
Filing date: 2017-01-05
Publication date: 2018-07-18
Anticipated expiration: 2037-01-05
Also published as: GB2558573B; GB201700159D0

Abstract

A medication monitoring device 28 is removably mountable to at least one of a portable hand-holdable housing 12 of a medicament dispenser 10 and an associated medication container 14, comprises a primary body 30, and a secondary body 34 which are interconnected by a flexible arm 36. The primary body 30 includes a flexible retainer 32 for releasably mounting to the portable hand-holdable housing 12, and a processor 48 in communication with a user-output clement 50 configured to provide a notification to a user when a dose of the medication is due according to a predetermined medication schedule. The secondary body 34 forms a cap which is releasably engagable with the medication container 14 and includes an activation sensor 78 for sensing an activation input applied by a user. The flexible arm 36 has a communications conduit 82 for transmitting an activation-signal output from the activation sensor 78 in the secondary body 34 to the processor 48 in the primary body 30, and forms a tether for tethering the secondary body 34 to the primary body 30. In another aspect a determination element which determines suitable agaition prior to delivery is described. In another aspect a display screen, merit demerit circuit is described. In another aspect a sensor corresponding to a medical discharge sound is described. In another aspect a predetermined medical schedule is described.

Description

(54) Title of the Invention: Improvements in or relating to a medicament dispenser Abstract Title: Monitoring device for medicament dispenser (57) A medication monitoring device 28 is removably mountable to at least one of a portable hand-holdable housing 12 of a medicament dispenser 10 and an associated medication container 14, comprises a primary body 30, and a secondary body 34 which are interconnected by a flexible arm 36. The primary body 30 includes a flexible retainer 32 for releasably mounting to the portable hand-holdable housing 12, and a processor 48 in communication with a user-output clement 50 configured to provide a notification to a user when a dose of the medication is due according to a predetermined medication schedule. The secondary body 34 forms a cap which is releasably engagable with the medication container 14 and includes an activation sensor 78 for sensing an activation input applied by a user. The flexible arm 36 has a communications conduit 82 for transmitting an activation-signal output from the activation sensor 78 in the secondary body 34 to the processor 48 in the primary body 30, and forms a tether for tethering the secondary body 34 to the primary body 30. In another aspect a determination element which determines suitable agaition prior to delivery is described. In another aspect a display screen, merit demerit circuit is described. In another aspect a sensor corresponding to a medical discharge sound is described. In another aspect a predetermined medical schedule is described.

At least one drawing originally filed was informal and the print reproduced here is taken from a later filed formal copy.

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Improvements In Or Relating To A Medicament Dispenser

The present invention relates to a medicament dispenser, medicament monitoring system using such a medicament dispenser, and to medication monitoring device forming part or for use with the medicament dispenser.

A medicament dispenser is well known, and one example is an inhaler having a bodytype housing and a medication container slidably housed in the body-type housing. When depressing the medication housing, the sliding movement into the housing activates an internal discharge mechanism, dispensing a required dose of medicine therefrom and thus allowing inhalation form the housing by a patient.

A more recent modification to the traditional inhaler provides for a two part housing having the body-type housing and a depressible button. The button causes a medication container which is entirely housed within the body-type housing to discharge a dose of the medicine into the housing. Once discharged, the patient inhales the medicine.

A problem with the aforementioned traditional design is that the manual depression of the slidable medication container results in the dose of medicine being forcibly discharged into a patient’s mouth. This frequently results in the medicine only reaching a back of a user’s throat and not being inhaled into the lungs.

The newer fully-enclosed medication container device described above seeks to solve this problem by depositing the discharged dose within the housing first, and then allowing a patient to inhale the deposited dose.

However, the traditional design is still widely used, and a common problem results in tracking usage of either device by a patient. A patient may miss a required dose according to a scheduled medicine regime prescribed by the patient’s doctor, and a patient and/or the patient’s carer or guardian should be able to determine this missed treatment.

It is known to provide a use-tracking device having a single body which is attachable to a projecting end of a medication container of the traditional design of inhaler. When the slidable medication container is pressed into the body-type housing, the use is registered and logged.

However, such a device requires quite a large single cap-type body to house the necessary electronics, resulting in a unit that is easily dislodged and lost from the inhaler, particularly if being used by a younger patient or an elderly or more infirm patient.

Additionally, the known device has no identifier allowing a patient to customise or identify their own inhaler from amongst many similar inhalers.

Little or no incentivisation for a patient to maintain their dose schedule is also provided. The onus is therefore on the patient to remember to abide or follow the prescribed routine outlined by the patient’s health care professional.

If the patient does have an incident, such as an asthma attack, through for example missing a dose of the medicine, the known device provides no emergency information to a third party to allow quick and efficient contact of a carer or guardian, and/or the patient’s doctor, along with critical patient data to allow optimised diagnosis by a health care professional, such as a paramedic, attending the incident.

The present invention seeks to provide a solution to these problems.

According to a first aspect of the invention, there is provided a medication monitoring device which is removably mountable to at least one of a portable hand-holdable housing of a medicament-delivery device and an associated medication container, the medication monitoring device comprising: a primary body, a secondary body which is connected to the primary body by a flexible arm, the primary body including a, preferably flexible, retainer for releasably mounting to the portable hand-holdable housing and a processor in communication with a user-output element configured to provide a notification to a user when a dose of the medication is due according to a predetermined medication schedule, the secondary body forming a cap which is releasably engagable with the medication container and including an activation sensor for sensing an activation input applied by a user, and the flexible arm having a communications conduit for transmitting an activation-signal output from the activation sensor in the secondary body to the processor in the primary body and forming a tether for tethering the secondary body to the primary body.

Preferable and/or optional features of the first aspect of the invention are set forth in claims 2 to 23, inclusive.

According to a second aspect of the invention, there is provided a medication monitoring device which is removably mountable to at least one of a portable handholdable housing of a medicament-delivery device and an associated medication container, the medication monitoring device comprising: a body including a flexible retainer for releasably mounting to the medicament-delivery device and a processor in communication with a user-output element configured to provide a notification to a user when a dose of the medication is due according to a predetermined medication schedule, a motion sensing device in communication with the processor, the motion sensing device configured to output to the processor a motion signal based on a motion of the portable hand-holdable housing, and a determination element configured to determine whether a predetermined motion of the portable hand-holdable housing has been achieved based on the predetermined medication schedule and consequently whether suitable agitation of a medicament in the medication container has occurred prior to delivery of a predetermined dose.

According to a third aspect of the invention, there is provided a medication monitoring device which is removably mountable to at least one of a portable hand-holdable housing of a medicament-delivery device and an associated medication container, the medication monitoring device comprising: a body including a flexible retainer for releasably mounting to the medicament-delivery device and a processor in communication with a user-output element configured to provide a notification to a user when a dose of the medication is due according to a predetermined medication schedule, a display screen on the said body, and a merit-demerit circuit in communication with the display screen and operable by the processor, an output of the merit-demerit circuit configured to display on the display screen an image associated with a merit or demerit dependent at least in part on a dose discharged from the discharge aperture relative to the predetermined medication schedule.

According to a fourth aspect of the invention, there is provided a medicament dispenser comprising: a portable hand-holdable housing, a medication container houseable at least partially within the portable hand-holdable housing, a discharge mechanism in the portable hand-holdable housing for delivering via one or more discharge apertures a predetermined dose from the medication container to an outlet of the portable handholdablc housing; a user-activation element operable by a user to activate the discharge mechanism; a medication monitoring device which is removably mountable to at least one of the portable hand-holdable housing and the medication container, the medication monitoring device including a primary body and a secondary body which is connected to the primary body by a flexible arm, the primary body including a flexible retainer for releasably mounting to the portable hand-holdable housing and a processor in communication with a user-output element configured to provide a notification to a user when a dose of the medication is due according to a predetermined medication schedule, the secondary body forming a cap which is releasably engagable with the medication container and including an activation sensor for sensing an activation input applied by a user, and the flexible arm having a communications conduit for transmitting an activation-signal output from the activation sensor in the secondary body to the processor in the primary body and forming a tether for tethering the secondary body to the primary body.

According to a fifth aspect of the invention, there is provided a medicament dispenser comprising: a portable hand-holdable housing, a medication container houseable at least partially within the portable hand-holdable housing, a discharge mechanism in the portable hand-holdable housing for delivering via one or more discharge apertures a predetermined dose from the medication container to an outlet of the portable handholdable housing; a user-activation element operable by a user to activate the discharge mechanism; and a medication monitoring device according to any one of the first to fourth aspects of the invention, releasably mounted to the housing and the useractivation element.

Preferable and/or optional features of the fifth aspect of the invention are set forth in claims 28 and 29.

According to a sixth aspect of the invention, there is provided a medicament monitoring system comprising a medicament dispenser according to the fifth aspect of the invention, a database which is externally remote from and in communication with the medicament dispenser to receive and store electronic data outputted from the useroutput element, and a user-display separate of the medicament dispenser and on which an output of the database can be displayed.

According to a seventh aspect of the invention, there is provided a medication monitoring device which is removably mountable to a portable hand-holdable housing of a medicament-delivery device, the medication monitoring device comprising: a monitoring-device housing; preferably a retainer for releasably mounting the monitoring-device housing to the portable hand-holdable housing; a processor in communication with a user-output element preferably configured to provide a notification to a user when a dose of the medication is due according to a predetermined medication schedule, and a discharge sensor at or in communication with the monitoring-device housing and configured to output a signal to the user-output element which corresponds to a medicine-discharge sound of the medicament-delivery device.

Preferable and/or optional features of the seventh aspect of the invention are set forth in claims 32 and 51, inclusive.

According to an eighth aspect of the invention, there is provided a medicament dispenser comprising: a portable hand-holdable housing, a medication container houseable at least partially within the portable hand-holdable housing, a discharge mechanism in the portable hand-holdable housing for delivering via one or more discharge apertures a predetermined dose from the medication container to an outlet of the portable hand-holdable housing; a user-activation element operable by a user to activate the discharge mechanism; a medication monitoring device which is removably mountable to at least one of the portable hand-holdable housing and the medication container, the medication monitoring device including a monitoring-device housing, a mounting element for releasably mounting the monitoring-device housing to the portable hand-holdable housing and a processor in communication with a user-output element configured to provide a notification to a user when a dose of the medication is due according to a predetermined medication schedule, and a discharge sensor at or in communication with the monitoring-device housing and configured to output a signal to the user-output element which corresponds to a medicine-discharge sound of the medicament-delivery device.

According to a ninth aspect of the invention, there is provided a medication monitoring device which is removably mountable to a portable hand-holdable housing of a medicament-delivery device, the medication monitoring device comprising: a monitoring-device housing; a processor in communication with a user-output element, and a discharge sensor at or in communication with the monitoring-device housing and configured to output a signal to the user-output element which corresponds to a medicine-discharge sound of the medicament-delivery device.

According to a tenth aspect of the invention, there is provided a medicament dispenser comprising: a portable hand-holdable housing, a medication container houseable at least partially within the portable hand-holdable housing, a discharge mechanism in the portable hand-holdable housing for delivering via one or more discharge apertures a predetermined dose from the medication container to an outlet of the portable handholdable housing; a user-activation element operable by a user to activate the discharge mechanism; a medication monitoring device which is removably mountable to at least one of the portable hand-holdable housing and the medication container, the medication monitoring device including a monitoring-device housing, a mounting element for releasably mounting the monitoring-device housing to the portable hand-holdable housing and a processor in communication with a user-output element configured to provide a notification to a user when a dose of the medication is due according to a predetermined medication schedule, and a discharge sensor at or in communication with the monitoring-device housing and configured to output a signal to the user-output element which corresponds to a medicine-discharge sound of the medicament-delivery device.

The invention will now be more particularly described, by way of example only, with reference to the accompanying drawings, in which:

Figure 1 shows a perspective front view of one embodiment of a medicament dispenser, in accordance with the fourth, eighth and ninth aspects of the invention and which includes a medication monitoring device according to the first to third and tenth aspects of the invention, a display screen on the front of the medication monitoring device showing a merit indicium when a dose is detected as being administered in accordance with the prescribed schedule;

Figure 2 is a view of the medicament dispenser and medication monitoring device, similar to Figure 1, but shown from the back;

Figure 3 is a simplified cross-sectional view through the medicament dispenser and medication monitoring device;

Figure 4 is a perspective front view of the medicament dispenser and medication monitoring device, showing an elastomeric overmoulding of the medication monitoring device removed for clarity;

Figure 5 is a perspective side view of the medicament dispenser and medication monitoring device, shown in Figure 1, and including an identification cover, in this case having an outer aesthetic layer representing a football or soccer ball, which is spaced from a primary body of the medication monitoring device; and

Figure 6, similarly to Figure 5, shows the identification cover but this time releasably mounted on the primary body to protect a front surface, for example a display screen, thereof along with a user-identification element on an inside surface of the identification cover and shown in phantom.

Referring to the drawings, there is shown one embodiment of a medicament dispenser 10, particularly but not necessarily exclusively for dispensing an inhalable pulmonary powdered or atomised medicine. The dispenser 10, which may also be considered an inhaler, comprises a housing 12, a medication container 14 slidably housed in the housing 12 so as to at least in part project from one end thereof, and a discharge mechanism 16 within the housing 12 and typically at the interior distal end 18 of the medication container 14.

The housing 12 is preferably a portable hand-holdable housing which may be formed of moulded plastics, and having an upright back portion 20 and an angled foot portion 22 integrally formed as one-piece with the back portion 20. The back portion 20 is generally tubular, having a proximal chamfered upper end 24 open to receive the typically cylindrical medication container 14 and with a uniform or substantially uniform lateral cross-section along at least a majority of its longitudinal extent.

Although not necessarily a complementary fit, the cylindrical medication container 14 is a receivable as a close slidable fit within the hollow interior of the back portion 20 whilst projecting through the open upper end 24.

The foot portion 22 preferably extends downwardly as well as laterally of the back portion 20. Other angles may be considered, such as right angles.

The foot portion 22 is also hollow, and may be tubular or slightly convergingly tapered to a discharge aperture 25 at a free lowermost end thereof, spaced from the back portion

20.

A user-activation element 26 is provided as part of each dispenser 10. In the case of the traditional design of housing 12 and medication container 14 shown in the accompanying drawings, the user-activation element 26 is formed as part of the projecting upper end 14a of the medication container 14, and in this case is typically a concavity, dished portion or recess 26a in an end wall thereof to receive a digit, typically a thumb, of a user.

In the case of newer designs of housing for a dispenser, such as an inhaler, the useractivation element is a depressible button formed as part of the housing. In this case, the button is slidably received in a main body of the housing to project therefrom, similarly to the traditional medication container.

In either case, the user-activation element 26 is operably connected to the discharge mechanism 16 contained within the housing 12. On pushing the user-activation element 26, either the medication container 14 is forced into the housing 12, causing the discharge mechanism 16 to release a predetermined dose of medicine from the medication container 14, or the user-activation element operates the discharge mechanism directly, resulting in a dose of the medicine being discharged from the internally housed medication container. As such, in the former case, the user-activation element 26 acts indirectly on the discharge mechanism 16 via the medication container 14, and in the latter case the user-activation element operates the discharge mechanism directly.

The dispenser 10 further comprises a medication monitoring device 28 which is releasably mountable to the back portion 20 of the portable hand-holdable housing 12 and the user-activation element 26.

The medication monitoring device 28 utilises a primary body 30 which is connectable to the back portion 20 of the housing 12 via a flexible retainer 32, and a secondary body 34 which is releasably mountable to the user-activation element 26, and more particularly in this case to the projecting upper end 24 of the medication container 14.

To tether the secondary body 34 to the primary body 30, a flexible arm 36 is provided which preferably extends integrally from one side of the secondary body 34 to a side of the primary body 30, as best shown in Figure 1.

The primary body 30, as seen in Figures 3 and 4, has a body housing 38 defining a perimeter wall 40 with a cavity 42 therein. The body housing 38 may conveniently be formed of moulded plastics, for example, and in this case is circular or generally circular. However, other non-circular shapes are possible, such as square or rectangular.

A rear wall 44 of the body housing 38 is preferably curved or concave in at least a side to side or lateral direction to accommodate the back portion 20 of the portable handholdable housing 12, and sides of the body housing 38 preferably terminate contiguously with the flexible retainer 32, in this example forming a continuous elastically pliable strap 32a, for example, formed from an elastomeric material.

The flexible retainer 32 is preferably dimensioned to provide with the body housing 38 an interference-fit opening for receiving the back portion 20 of the portable handholdable housing 12, thus inhibiting or preventing unintentional slidable separation of the two parts.

The flexible retainer may be formed as two interengagable parts, having a connector or buckle for releasable engagement thereof.

A light transmissible portion 46 is preferably provided on a wall of the primary body 30, thereby in part defining the cavity 42. In this case, the light transmissible portion 46 is a transparent annular element 46a, which may be clear or coloured to provide a continuous or substantially continuous light path. The light transmissible portion 46 may be selectable from amongst a plurality of differently coloured elements, and as such may be sclcctably interchangeable, for example, by a patient wanting to distinguish their dispenser 10 from others.

The transparent annular element 46a is a broken ring, in this example, and as best seen in Figure 4 is seated on the wall 40 of the primary body 30 to define at least in part a rim of the cavity 42. Again, however, other shapes of light transmissible portions can be utilised to at least in part match a perimeter shape of the primary housing 12.

Within the cavity 42 is provided a processor 48 and a user-output element 50. The processor 48 utilises a memory element 52 to store a predetermined medication schedule of the patient and a timer 54. The processor 48 thus controls the user-output element 50 to output an alert signal to the user. The user-output element 50 may be a radio-frequency transmitter for transmitting a signal to an external remote mobile personal computing device 56, such as a smartphone, tablet or laptop, and/or to a desktop computer 58 or other suitable receiver providing user-notification means. Wireless data transmission protocols that can be considered are Bluetooth RTM, NFC, and Wi-Fi, amongst others.

The user-output element 50 may additionally or alternatively include a local alert device, such as an integrated or on-board speaker, other audio output device, vibration element, tactile or haptic feedback element, and/or visual display element. The visual display element may beneficially be a light emitting element 60, for example, one or more light-emitting diodes received within or adjacent to the cavity 42. A visual alert in this later case is thus conveniently realised via the light transmissible portion 46 of the body housing 38, which as a consequence may be considered to form part of the useroutput element 50.

Additionally provided in the cavity 42 preferably as an optional feature is a meritdemerit element 62, which in this case is preferably provided as part of or in communication with the processor 48 as a merit-demerit circuit 62a. A display screen 64 may thus be utilised to close the cavity 42, and the merit-demerit element 62 enables display of an image 66 associated with a merit or demerit dependent at least in part on a dose discharged from the discharge aperture 25 relative to the predetermined medication schedule. For example, the image 66 may relate to accumulated points or a digital pet. The closer in time the patient discharges the medicine from the medication container 14 in accordance with the predetermined medication schedule, the more points are accumulated or the healthier the digital pet becomes. Conversely, the greater a period between the required medication schedule and the discharge of the medicine, the more points are lost or the unhealthier the digital pet becomes.

Additionally or alternatively, the merit-demerit element 62 preferably communicates either directly or indirectly with the user-output element 50, thereby allowing remote logging, tracking, display and/or social or public competition.

The secondary body 34, in this embodiment, forms a tight interference-fit cap which can be releasably pressed, urged or push fit onto the upper end 24 of the medication container 14, thus covering and engaging the user-activation element 26.

As best seen in Figure 3, the secondary body 34 preferably includes a base element 68 forming a first cap part 68a and defining a recess 70 for receipt of the user-activation element 26, and an overmoulded cover 72 forming a second cap part 72a mounted on an outer-facing major surface of the base element 68. Conveniently, the overmoulded cover 72, for example being an elastomeric material for comfort and protection, may be engaged with the base element 68 via a plug 74 received in an aperture through base surface of the base element 68.

Within the secondary body 34 is provided an activation sensor 78, which in this case may beneficially be a pressure sensor 78a. Such a pressure sensor 78a is preferably integrated within the overmoulded cover 72, and an output cable 80 extends within the flexible arm 36, which thus provides a communications conduit 82. An activation signal outputted by the pressure sensor 78a is thus transmitted to the processor 48 in the primary body 30 via the output cable 80 housed within the flexible arm 36.

Additionally, the activation sensor 78 may be electrically powerable via the or a cable 80 received within the flexible arm 36 from a power source locatable within the primary body 30. A profile or dimensions of the secondary body 34 can thus be reduced or minimised, thereby reducing an overall length of the dispenser 10.

A further activation sensor 178 may also be provided, and in this case is preferably a discharge sensor 178a, such as an audio or noise sound sensor 178b typically coupled to a filter circuit 178c to determine a characteristic sound associated with operation of the dispenser 10.

In this case, the sound sensor 178b and filter circuit 178c may conveniently be provided in the primary body 30, with the sound sensor 178b preferably positioned within the primary body 30 to be at, on or adjacent to the wall of the back portion 20 of the housing 12 when the primary body 30 is attached thereto.

In use, the further activation sensor 178 will receive sound energy from the discharge of the medicine from the medication container 14, when the user-activation element 26 is operated. The noise or sound of the discharge of the medicine is or is substantially consistent having a reliably recognisable signature, and as such the filter circuit 178c can be programmed to differentiate between incidental environmental noises around the user and the sound produced by the discharge of the medicine from the container 14.

Optionally, the further activation sensor 178 may only be energised following an input by the first said activation sensor 78, which may be a pressure sensor or other suitable switch or input device. In these latter cases, the said first activation sensor may be an activation element rather than simply a sensor.

To improve the flexibility, the flexible arm 36 may advantageously include one or more recessed portions, thereby improving the ease of articulation on movement of the useractivation element 26 relative to the back portion 20 of the housing 12. The inherent resilience of the flexible arm 36 is thus less likely to cause unintended removal, displacement or dislodgement of the secondary body 34 from the user-activation element 26 during use, storage and general everyday use and movement.

It is also considered advantageous to include a motion sensing device 86 in communication with the processor 48. Conveniently, the motion sensing device 86 may be accommodated in the cavity 42 of the primary body 30, and for example may be a motion sensor 86a, such as an accelerometer.

A motion signal can thus be outputted form the motion sensing device 86 to the useroutput element 50 for local and/or remote display and logging.

Preferably, in addition to the motion sensing device 86, a determination element 88 is also provided. This may be local, formed as a circuit forming part of the processor 48 or separately within the cavity 42, and/or provided remotely to analyse motion-signal data being outputted from the primary body 30.

The determination element 88, which may be a determination circuit 88a as part of or associated with the processor 48, is adapted or configured to determine whether a predetermined motion of the portable hand-holdable housing 12 has been achieved, preferably based on the predetermined medication schedule, and consequently whether suitable agitation of a medicament in the medication container 14 has occurred prior to delivery of a predetermined dose. By way of a more specific example, a patient is often instructed as part of the prescription by the health care professional to shake the dispenser 10 thoroughly three times prior to administering the dose in order to separate and break up any compacted powder composition within the medication container 14. By monitoring a shaking or agitation force applied by the user prior to discharge of the medicine, user feedback can be provided. Additionally, the determination element 88 may communicate with the merit-demerit element 62 to supplement or remove a credit given to the patient, thereby encouraging the user to improve or maintain the required shaking or agitation of the medicine.

Referring to Figures 5 and 6, the primary body 30 may further comprise a first part 90a of a holding mechanism 90 for releasably engaging an identification cover 92 with a complementary second part 90b of the holding mechanism 90 thereon.

The first part 90a of the holding mechanism 90 may be a recess, such as a channel in an outer surface of the body housing 38, and this may be accommodated or provided by the light transmissible portion 46.

The second part 90b may conveniently be one or more opposing tabs, tongues or projections enabling a snap-fit releasable engagement of the identification cover 92 over a front surface, which may be or include a display screen 64, of the primary body 30.

The first and second parts 90a and 90b of the holding mechanism 90 may be reversed, if required. Additionally or alternatively, other holding means can be considered to form the holding mechanism, such as a screw thread engagement between the parts, or a twist and lock bayonet arrangement.

Beneficially, the identification cover 92 preferably includes a display surface 94 on which may be provided an aesthetic adornment 96, such as a static picture or image, for example, of a football or soccer ball, a preferred team logo or name, character or item. An outwardly facing surface of the identification cover 92 is preferably convex to better display the picture or image. An inwardly facing surface is therefore preferably concave. However, the shapes of these surfaces may be reversed, or one or both may be flat.

A said identification cover 92 may be selectable from amongst a plurality of different such covers, allowing a user to individualise their dispenser 10.

The identification cover 92 is particularly beneficial in allowing a user to customise and thus better identify their own personal dispenser 10. Equally, the identification cover 92 provides additional protection for the primary housing 12 during day to day use, particularly by the young and elderly or infirm.

The identification cover 92 may additionally or alternatively include a useridentification element 98 on a surface thereof, shown in Figures 5 and 6 in phantom outline. The user-identification element 98 preferably has an optically device-readable identifier 98a configured to enable communication with a or the database storing, for example, emergency medical and/or contact details of the user of the dispenser 10.

To assist in maintaining privacy, the user-identification element 98 is, in this nonlimiting example, located on an inner surface of the identification cover 92 facing the body housing 38 and/or display screen 64 of the primary body 30. Consequently, in an emergency situation, a carer with the patient in distress can remove the identification cover 92 and using an optical reader of their personal mobile computing device, again, such as a camera on a smartphone, can scan the user-identification element 98, which may be a barcode or QR code, to access the patient’s name, emergency contact number, doctor’s details, blood type, allergies, medication requirements, and so on in order to administer or provide appropriate assistance.

In use, a medicament monitoring system 100 is formed which comprises the abovedescribed medicament dispenser 10, a database 102 which is externally remote from and in communication with the medicament dispenser 10, and a user-display 104 which is separate of the medicament dispenser 10.

The predetermined medicament schedule is loaded into the internal memory of the primary body 30 and the associated timer 54. The processor 48 utilises the user-output element 50 to provide a local and/or remote alert to the user, and this may be via the light transmissible portion 46 on the primary body 30 and/or via the user-display 104 on a user’s mobile telecommunications device, such as a smartphone, and/or personal computer.

Any output provided by the user-output element 50 is preferably logged on the database 102, and the database 102 may be local and/or remote. The remote version of the database 102 may be stored locally on a remote wirelessly connected personal device, again, for example, the user’s smartphone or personal computer, and/or on a network of remote servers hosted on the Internet, typically referred to as the Cloud 106.

With the alert outputted, the patient then prepares the dispenser 10 for dose administration, in the case of an inhaler, typically by shaking the unit vigorously. The motion sensing device 86 monitors this movement and again outputs relevant motion sensing data via the user-output element 50 and preferably to the remote database 102.

With the medicine in the medication container 14 prepared, the user-activation element 26 can be operated via the secondary body 34, and the pressure sensor 78a outputs the pressure sensing signal from the user’s applied force to the database 102 via the useroutput element 50. Additionally or alternatively, the discharge sensor 178a preferably being the sound sensor 178b recognises the sound of the medicine being discharged into and/or from the housing 12 and outputs a discharge signal to the database 102 via the user-output element 50.

With the alert data, motion sensing data, pressure sensor data and/or discharge sensor data from the user-output element 50 notified and/or logged, a patient, carer and/or guardian can access the data to confirm adherence to the predetermined medicament schedule. Feedback can thus be given to improve the dose administration.

Furthermore, if utilised, the merit-demerit circuit 62a can additionally output data via the user-output element 50 to the database 102 and display not only on a user’s personal account, but also on a social or public account, for example, for competition and/or reward.

Although preferably uniformly straight or substantially straight, the back portion and/or the foot portion may waisted and/or bulged at least in part along the or each respective longitudinal extent. Other materials, aside from plastics, may also be considered for forming the housing as necessity dictates, and although moulding is preferred, other manufacturing process, if appropriate, may be utilised.

Although the foot portion of the portable hand-holdable housing preferably defines a single discharge aperture, two or more such apertures may be provided, again as necessity dictates.

Although the flexible retainer is in strap form, it may have a width which is greater than a diameter or major dimension of the primary body, dependent on necessity.

Additionally or alternatively, any suitable retaining means may be considered, and as such the retainer may not necessarily be flexible but may be rigid. For example, the retaining means may be a clamp that clamps the primary body around the back portion of the housing.

Although mountable to both the main body of the housing and the user-activation element, which may be part of the medication container or part of the housing as described previously, the medication monitoring device may be mounted to only one of the housing, user-activation element and medication container depending on the sensors utilised.

The discharge sensor or other discharge determining means, preferably being able to monitor sound or noise, may be utilised instead of the pressure sensor. In this case, the first said activation sensor or activation element on the secondary body may be omitted. As a result, the secondary body may be dispensed with. In this case, the flexible arm may also be dispensed with. With the secondary body and the flexible arm omitted, the sound sensor or other discharge determining means is provided in the primary body, which may be considered to be a single monitoring-device housing attachable in piggyback manner to the back portion of the dispenser housing.

It may be feasible that the discharge sensor or other discharge determining means is positioned closer to the discharge aperture, and as such may be located at, on or adjacent to the foot portion of the dispenser housing. In this case, the discharge determining means may be spaced from the monitoring-device housing, for example, being at or in an arm or annex which projects therefrom.

Although preferably the processor, which is in communication with the user-output element or other suitable signal transmission or output means, is configured to provide a notification to a user when a dose of the medication is due according to a predetermined medication schedule, the processor may only be configured to output the discharge data to a remote database instead of or in addition to providing the user notification that a medicine dose is due.

It is thus possible to provide a medication monitoring device which tethers a secondary body to a primary body piggybacked to an inhaler, other pulmonary medicine dispenser, or other medicament dispensing device whilst maintaining connectivity between the two bodies. The secondary body, which may be optional in some embodiments, is slim-lined with a reduced height profile to reduce the chance of unintentional by knocking or incorrect user engagement. The device is also able to output user data seamlessly to a remote computing device for logging and display, and may include motion detection to determine and guide correct agitation. The output user data may be at least one or both of pressure sensing data and/or sound sensing data associated with a discharge event. An optional display enables merit and demerit engagement for a user to encourage compliance with a medication schedule. It is also possible to provide emergency patient data via an identification cover releasably connectable to the primary body.

The words ‘comprises/comprising’ and the words ‘having/including’ when used herein with reference to the present invention are used to specify the presence of stated features, integers, steps or components, but do not preclude the presence or addition of one or more other features, integers, steps, components or groups thereof.

It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination.

The embodiments described above are provided by way of examples only, and various other modifications will be apparent to persons skilled in the field without departing from the scope of the invention as defined herein.

Claims

1. A medication monitoring device which is removably mountable to at least one of a portable hand-holdable housing of a medicament-delivery device and an associated medication container, the medication monitoring device comprising:

a primary body, a secondary body which is connected to the primary body by a flexible arm, the primary body including a retainer for releasably mounting to the portable hand-holdable housing and a processor in communication with a user-output element configured to provide a notification to a user when a dose of the medication is due according to a predetermined medication schedule, the secondary body forming a cap which is releasably engagable with the medication container and including an activation sensor for sensing an activation input applied by a user, and the flexible arm having a communications conduit for transmitting an activationsignal output from the activation sensor in the secondary body to the processor in the primary body and forming a tether for tethering the secondary body to the primary body.

2. A medication monitoring device as claimed in claim 1, wherein the user-output element includes a transmitter for the transmission of data using a wireless protocol, and the processor is configured to provide a dose-administered data output to the useroutput element.

3. A medication monitoring device as claimed in claim 1 or claim 2, wherein the primary body includes a light transmissible portion at or adjacent to a perimeter edge thereof.

4. A medication monitoring device as claimed in claim 3, wherein the light transmissible portion defines a continuous or substantially continuous light path around the perimeter body.

5. A medication monitoring device as claimed in claim 3 or claim 4, wherein the light transmissible portion forms part of the user-output element.

6. A medication monitoring device as claimed in any one of the preceding claims, wherein the primary body further comprises a first part of a holding mechanism for releasably engaging an identification cover.

7. A medication monitoring device as claimed in claim 6, wherein the first part of the holding mechanism includes at least one recess for receiving a second part of the holding mechanism on the identification cover.

8. A medication monitoring device as claimed in claim 6 or claim 7, further comprising an identification cover which is releasably engagable with the primary body via the holding mechanism.

9. A medication monitoring device as claimed in claim 8, wherein the identification cover includes the or a second part of the holding mechanism formed to engage with the said first part.

10. A medication monitoring device as claimed in claim 9, wherein the second part of the holding mechanism is an inwardly extending protrusion.

11. A medication monitoring device as claimed in any one of claim 8 to 10, wherein the identification cover is selectable from amongst a plurality of different interchangeable identification covers.

12. A medication monitoring device as claimed in any one of claims 8 to 11, wherein the identification cover includes a user-identification element on a surface thereof.

13. A medication monitoring device as claimed in claim 12, wherein the useridentification element includes an optically device-readable identifier configured to enable communication with a database storing emergency medical and/or contact details of the user of the dispenser.

14. A medication monitoring device as claimed in claim 13, wherein useridentification element is located on a surface of the identification cover facing the primary body.

15. A medication monitoring device as claimed in any one of the preceding claims, wherein the flexible retainer is a continuous elastically pliable strap formed with the primary body to provide an interference-fit opening for releasably receiving the portable hand-holdable housing.

16. A medication monitoring device as claimed in any one of the preceding claims, wherein the primary body further includes a display screen, and the processor further includes a merit and demerit circuit in communication with the display screen, an output of the merit and demerit circuit configured to display on the display screen an image associated with a merit or demerit dependent on a dose discharged from the discharge aperture relative to the predetermined medication schedule.

17. A medication monitoring device as claimed in any one of the preceding claims, further comprising a motion sensing device in communication with the processor, the motion sensing device configured to output to the processor a motion signal based on a motion of the in use portable hand-holdable housing.

18. A medication monitoring device as claimed in claim 17, further comprising a determination element for determining whether a predetermined motion of the in use portable hand-holdable housing has been achieved based on the predetermined medication schedule and consequently whether suitable agitation of a medicament in the associated medication container has occurred prior to delivery of the said predetermined dose.

19. A medication monitoring device as claimed in any one of the preceding claims, wherein the secondary body has a first cap part having an opening for receiving an in use proximal end of the user-activation element as an interference push-fit.

20. A medication monitoring device as claimed in claim 19, wherein the secondary body has a second cap part on a user-facing surface which is opposite a housing-facing surface of the first cap part, the second cap part including the said activation sensor.

21. A medication monitoring device as claimed in claim 20, wherein the activation sensor is a pressure sensor for determining a pressure applied as the activation input by a user.

22. A medication monitoring device as claimed in any one of the preceding claims, wherein the flexible arm includes one or more recessed portions as part of the tether to accommodate movement of the in use secondary body relative to the primary body.

23. A medication monitoring device as claimed in any one of the preceding claims, wherein the flexible arm is integrally formed as one-piece with the primary body and the secondary body.

24. A medication monitoring device which is removably mountable to at least one of a portable hand-holdable housing of a medicament-delivery device and an associated medication container, the medication monitoring device comprising:

a body including a retainer for releasably mounting to the medicament-delivery device and a processor in communication with a user-output element configured to provide a notification to a user when a dose of the medication is due according to a predetermined medication schedule, a motion sensing device in communication with the processor, the motion sensing device configured to output to the processor a motion signal based on a motion of the portable hand-holdable housing, and a determination element configured to determine whether a predetermined motion of the portable hand-holdable housing has been achieved based on the predetermined medication schedule and consequently whether suitable agitation of a medicament in the medication container has occurred prior to delivery of a predetermined dose.

25. A medication monitoring device which is removably mountable to at least one of a portable hand-holdable housing of a medicament-delivery device and an associated medication container, the medication monitoring device comprising:

a body including a flexible retainer for releasably mounting to the medicamentdelivery device and a processor in communication with a user-output element configured to provide a notification to a user when a dose of the medication is due according to a predetermined medication schedule, a display screen on the said body, and a merit-demerit circuit in communication with the display screen and operable by the processor, an output of the merit-demerit circuit configured to display on the display screen an image associated with a merit or demerit dependent at least in part on a dose discharged from the discharge aperture relative to the predetermined medication schedule.

26. A medicament dispenser comprising:

a portable hand-holdable housing, a medication container houseable at least partially within the portable handholdable housing, a discharge mechanism in the portable hand-holdable housing for delivering via one or more discharge apertures a predetermined dose from the medication container to an outlet of the portable hand-holdable housing;

a user-activation element operable by a user to activate the discharge mechanism;

a medication monitoring device which is removably mountable to at least one of the portable hand-holdable housing and the medication container, the medication monitoring device including a primary body and a secondary body which is connected to the primary body by a flexible arm, the primary body including a flexible retainer for releasably mounting to the portable hand-holdable housing and a processor in communication with a user-output element configured to provide a notification to a user when a dose of the medication is due according to a predetermined medication schedule, the secondary body forming a cap which is releasably engagable with the medication container and including an activation sensor for sensing an activation input applied by a user, and the flexible arm having a communications conduit for transmitting an activationsignal output from the activation sensor in the secondary body to the processor in the primary body and forming a tether for tethering the secondary body to the primary body.

27. A medicament dispenser comprising:

a portable hand-holdable housing, a medication container houseable at least partially within the portable hand-holdable housing, a discharge mechanism in the portable hand-holdable housing for delivering via one or more discharge apertures a predetermined dose from the medication container to an outlet of the portable hand-holdable housing;

a user-activation element operable by a user to activate the discharge mechanism; and a medication monitoring device as claimed in any one of claims 1 to 25, releasably mounted to the housing and the user-activation element.

28. A medicament dispenser as claimed in claim 26 or claim 27, wherein the useractivation element is a proximal end of the medication container.

29. A medicament dispenser as claimed in claim 26 or claim 27, wherein the useractivation element is a movable part of the portable hand-holdable housing, the movable part operatively communicable with the discharge mechanism.

30. A medicament monitoring system comprising a medicament dispenser as claimed in any one of claims 26 to 29, a database which is externally remote from and in communication with the medicament dispenser to receive and store electronic data outputted from the user-output element, and a user-display separate of the medicament dispenser and on which an output of the database can be displayed.

31. A medication monitoring device which is removably mountable to a portable hand-holdable housing of a medicament-delivery device, the medication monitoring device comprising:

a monitoring-device housing;

a retainer for releasably mounting the monitoring-device housing to the portable hand-holdable housing and a processor in communication with a user-output element configured to provide a notification to a user when a dose of the medication is due according to a predetermined medication schedule, and a discharge sensor at or in communication with the monitoring-device housing and configured to output a signal to the user-output element which corresponds to a medicine-discharge sound of the medicament-delivery device.

32. A medication monitoring device as claimed in claim 31, wherein the discharge sensor is a sound sensor.

33. A medication monitoring device as claimed in claim 31 or claim 32, further comprising a secondary housing forming a cap which is releasably engagable with the medicament-delivery device and including an activation sensor for sensing an activation input applied by a user,

34. A medication monitoring device as claimed in claim 33, further comprising a flexible arm having a communications conduit for transmitting an activation-signal output from the activation sensor in the secondary housing to the processor in the monitoring-device housing and forming a tether for tethering the secondary housing to the monitoring-device housing.

35. A medication monitoring device as claimed in any one of claims 31 to 34, wherein the user-output element includes a transmitter for the transmission of data using a wireless protocol, and the processor is configured to provide a dose-administered data output to the user-output element.

36. A medication monitoring device as claimed in any one of claims 31 to 35, wherein the monitoring-device housing includes a light transmissible portion at or adjacent to a perimeter edge thereof.

37. A medication monitoring device as claimed in claim 36, wherein the light transmissible portion defines a continuous or substantially continuous light path around the perimeter body.

38. A medication monitoring device as claimed in claim 36 or claim 37, wherein the light transmissible portion forms part of the user-output element.

39. A medication monitoring device as claimed in any one of claims 31 to 38, wherein the monitoring-device housing further comprises a first part of a holding mechanism for releasably engaging an identification cover.

40. A medication monitoring device as claimed in claim 39, wherein the first part of the holding mechanism includes at least one recess for receiving a second part of the holding mechanism on the identification cover.

41. A medication monitoring device as claimed in claim 39 or claim 40, further comprising an identification cover which is releasably engagable with the monitoringdevice housing via the holding mechanism.

42. A medication monitoring device as claimed in claim 41, wherein the identification cover includes the or a second part of the holding mechanism formed to engage with the said first part.

43. A medication monitoring device as claimed in claim 42, wherein the second part of the holding mechanism is an inwardly extending protrusion.

44. A medication monitoring device as claimed in any one of claim 41 to 43, wherein the identification cover is selectable from amongst a plurality of different interchangeable identification covers.

45. A medication monitoring device as claimed in any one of claims 41 to 44, wherein the identification cover includes a user-identification element on a surface thereof.

46. A medication monitoring device as claimed in claim 45, wherein the useridentification element includes an optically device-readable identifier configured to enable communication with a database storing emergency medical and/or contact details of the user of the dispenser.

47. A medication monitoring device as claimed in claim 46, wherein useridentification element is located on a surface of the identification cover facing the monitoring-device housing.

48. A medication monitoring device as claimed in any one of claims 31 to 47, wherein the retainer is a continuous elastically pliable strap formed with the monitoringdevice housing to provide an interference-fit opening for releasably receiving the portable hand-holdable housing.

49. A medication monitoring device as claimed in any one of claims 31 to 48, wherein the monitoring-device housing further includes a display screen, and the processor further includes a merit and demerit circuit in communication with the display screen, an output of the merit and demerit circuit configured to display on the display screen an image associated with a merit or demerit dependent on a dose discharged from the discharge aperture relative to the predetermined medication schedule.

50. A medication monitoring device as claimed in any one of claims 31 to 49, further comprising a motion sensing device in communication with the processor, the motion sensing device configured to output to the processor a motion signal based on a motion of the in use portable hand-holdable housing.

51. A medication monitoring device as claimed in claim 50, further comprising a determination element for determining whether a predetermined motion of the in use portable hand-holdable housing has been achieved based on the predetermined medication schedule and consequently whether suitable agitation of a medicament in the associated medication container has occurred prior to delivery of the said predetermined dose.

52. A medication monitoring device which is removably mountable to a portable hand-holdable housing of a medicament-delivery device, the medication monitoring device comprising:

a monitoring-device housing;

a processor in communication with a user-output element, and a discharge sensor at or in communication with the monitoring-device housing and configured to output a signal to the user-output element which corresponds to a medicine-discharge sound of the medicament-delivery device.

53. A medicament dispenser comprising:

a medication monitoring device which is removably mountable to at least one of the portable hand-holdable housing and the medication container, the medication monitoring device including a monitoring-device housing, a mounting element for releasably mounting the monitoring-device housing to the portable hand-holdable housing and a processor in communication with a user-output element configured to provide a notification to a user when a dose of the medication is due according to a predetermined medication schedule, and

5 a discharge sensor at or in communication with the monitoring-device housing and configured to output a signal to the user-output element which corresponds to a medicine-discharge sound of the medicament-delivery device.

Intellectual

Property

Office

Application No: GB1700159.5 Examiner: Dr Matthew Parker