Patent ID: 12220524

DETAILED DESCRIPTION

It should be understood that the detailed description and specific examples, while indicating exemplary embodiments of the apparatus, systems and methods, are intended for purposes of illustration only and are not intended to limit the scope of the invention. These and other features, aspects, and advantages of the apparatus, systems and methods of the present invention will become better understood from the following description, appended claims, and accompanying drawings. It should be understood that the Figures are merely schematic and are not drawn to scale. It should also be understood that the same reference numerals are used throughout the figures to indicate the same or similar parts.

Asthma and COPD are chronic inflammatory disease of the airways. They are both characterized by variable and recurring symptoms of airflow obstruction and bronchospasm. The symptoms include episodes of wheezing, coughing, chest tightness and shortness of breath.

The symptoms are managed by avoiding triggers and by the use of medicaments, particularly inhaled medicaments. The medicaments include inhaled corticosteroids (ICSs) and bronchodilators.

Inhaled corticosteroids (ICSs) are steroid hormones used in the long-term control of respiratory disorders. They function by reducing the airway inflammation. Examples include budesonide, beclomethasone (dipropionate), fluticasone (propionate or furoate), mometasone (furoate), ciclesonide and dexamethasone (sodium). Parentheses indicate preferred salt or ester forms. Particular mention should be made of budesonide, beclomethasone and fluticasone, especially budesonide, beclomethasone dipropionate, fluticasone propionate and fluticasone furoate.

Different classes of bronchodilators target different receptors in the airways. Two commonly used classes are β2-agonists and anticholinergics.

β2-Adrenergic agonists (or “β2-agonists”) act upon the β2-adrenoceptors which induces smooth muscle relaxation, resulting in dilation of the bronchial passages. They tend to be categorised by duration of action. Examples of long-acting β2-agonists (LABAs) include formoterol (fumarate), salmeterol (xinafoate), indacaterol (maleate), bambuterol (hydrochloride), clenbuterol (hydrochloride), olodaterol (hydrochloride), carmoterol (hydrochloride), tulobuterol (hydrochloride) and vilanterol (triphenylacetate). Examples of short-acting β2-agonists (SABA) are albuterol (sulfate) and terbutaline (sulfate). Particular mention should be made of formoterol, salmeterol, indacaterol and vilanterol, especially formoterol fumarate, salmeterol xinafoate, indacaterol maleate and vilanterol triphenylacetate.

Typically short-acting bronchodilators provide a rapid relief from acute bronchoconstriction (and are often called “rescue” or “reliever” medicines), whereas long-acting bronchodilators help control and prevent longer-term symptoms. However, some rapid-onset long-acting bronchodilators may be used as rescue medicines, such as formoterol (fumarate). Thus, a rescue medicine provides relief from acute bronchoconstriction. The rescue medicine is taken as-needed/prn (pro re nata). The rescue medicine may also be in the form of a combination product, e.g. ICS-formoterol (fumarate), typically budesonide-formoterol (fumarate) or beclomethasone (dipropionate)-formoterol (fumarate). Thus, the rescue medicine is preferably a SABA or a rapid-acting LABA, more preferably albuterol (sulfate) or formoterol (fumarate), and most preferably albuterol (sulfate).

Anticholinergics (or “antimuscarinics”) block the neurotransmitter acetylcholine by selectively blocking its receptor in nerve cells. On topical application, anticholinergics act predominantly on the M3muscarinic receptors located in the airways to produce smooth muscle relaxation, thus producing a bronchodilatory effect. Examples of long-acting muscarinic antagonists (LAMAS) include tiotropium (bromide), oxitropium (bromide), aclidinium (bromide), umeclidinium (bromide), ipratropium (bromide) glycopyrronium (bromide), oxybutynin (hydrochloride or hydrobromide), tolterodine (tartrate), trospium (chloride), solifenacin (succinate), fesoterodine (fumarate) and darifenacin (hydrobromide). Particular mention should be made of tiotropium, aclidinium, umeclidinium and glycopyrronium, especially tiotropium bromide, aclidinium bromide, umeclidinium bromide and glycopyrronium bromide.

A number of approaches have been taken in preparing and formulating these medicaments for delivery by inhalation, such as via a dry powder inhaler (DPI), a pressurized metered dose inhaler (pMDI) or a nebulizer.

According to the GINA (Global Initiative for Asthma) Guidelines, a step-wise approach is taken to the treatment of asthma. At step 1, which represents a mild form of asthma, the patient is given an as needed SABA, such as albuterol sulfate. The patient may also be given an as-needed low-dose ICS-formoterol, or a low-dose ICS whenever the SABA is taken. At step 2, a regular low-dose ICS is given alongside the SABA, or an as-needed low-dose ICS-formoterol. At step 3, a LABA is added. At step 4, the doses are increased and at step 5, further add-on treatments are included such as an anticholinergic or a low-dose oral corticosteroid. Thus, the respective steps may be regarded as treatment regimens, which regimens are each configured according to the degree of acute severity of the respiratory disease.

COPD is a leading cause of death worldwide. It is a heterogeneous long-term disease comprising chronic bronchitis, emphysema and also involving the small airways. The pathological changes occurring in patients with COPD are predominantly localised to the airways, lung parenchyma and pulmonary vasculature. Phenotypically, these changes reduce the healthy ability of the lungs to absorb and expel gases.

Bronchitis is characterised by long-term inflammation of the bronchi. Common symptoms may include wheezing, shortness of breath, cough and expectoration of sputum, all of which are highly uncomfortable and detrimental to the patient's quality of life. Emphysema is also related to long-term bronchial inflammation, wherein the inflammatory response results in a breakdown of lung tissue and progressive narrowing of the airways. In time, the lung tissue loses its natural elasticity and becomes enlarged. As such, the efficacy with which gases are exchanged is reduced and respired air is often trapped within the lung. This results in localised hypoxia, and reduces the volume of oxygen being delivered into the patient's bloodstream, per inhalation. Patients therefore experience shortness of breath and instances of breathing difficulty.

Patients living with COPD experience a variety, if not all, of these symptoms on a daily basis. Their severity will be determined by a range of factors but most commonly will be correlated to the progression of the disease. These symptoms, independent of their severity, are indicative of stable COPD and this disease state is maintained and managed through the administration of a variety drugs. The treatments are variable, but often include inhaled bronchodilators, anticholinergic agents, long-acting and short-acting β2-agonists and corticosteroids. The medicaments are often administered as a single therapy or as combination treatments.

Patients are categorised by the severity of their COPD using categories defined in the GOLD Guidelines (Global Initiative for Chronic Obstructive Lung Disease, Inc.). The categories are labelled A-D and the recommended first choice of treatment varies by category. Patient group A are recommended a short-acting muscarinic antagonist (SAMA) pm or a short-acting β2-aginist (SABA) pm. Patient group B are recommended a long-acting muscarinic antagonist (LAMA) or a long-acting β2-aginist (LABA). Patient group C are recommended an inhaled corticosteroid (ICS)+a LABA, or a LAMA. Patient group D are recommended an ICS+a LABA and/or a LAMA.

Patients suffering from respiratory diseases like asthma or COPD suffer from periodic exacerbations beyond the baseline day-to-day variations in their condition. An exacerbation is an acute worsening of respiratory symptoms that require additional therapy, i.e. a therapy going beyond their maintenance therapy.

For asthma, the additional therapy for a moderate exacerbation are repeated doses of SABA, oral corticosteroids and/or controlled flow oxygen (the latter of which requires hospitalization). A severe exacerbation adds an anticholinergic (typically ipratropium bromide), nebulized SABA or IV magnesium sulfate.

For COPD, the additional therapy for a moderate exacerbation are repeated doses of SABA, oral corticosteroids and/or antibiotics. A severe exacerbation adds controlled flow oxygen and/or respiratory support (both of which require hospitalization). An exacerbation within the meaning of the present disclosure includes both moderate and severe exacerbations.

Provided is a system comprising at least one first inhaler which delivers a first medicament to a subject. One or more (or each) of the at least one first inhaler comprises a first use determination system configured to determine a first value of a usage parameter relating to use of the respective first inhaler. One or more (or each) of the at least one inhaler also comprises a first transmission module configured to encrypt first data based on the first value, and transmit the encrypted first data. The system further comprises at least one second inhaler which delivers a second medicament to the subject. The second medicament is different from the first medicament. One or more (or each) of the at least one second inhaler comprises a second use determination system configured to determine a second value of a usage parameter relating to use of the respective second inhaler, and a second transmission module configured to encrypt second data based on the second value, and transmit the encrypted second data. The system includes a user interface, and a processing module. The processing module receives the first encrypted data and the second encrypted data, and distinguishes between the first encrypted data and the second encrypted data. The processing module determines first usage information relating to the first medicament from the distinguished first encrypted data, and determines second usage information relating to the second medicament from the distinguished second encrypted data. The processing module controls the user interface to communicate the first and second usage information.

One or more (or each) of the at least one first inhaler is configured to deliver a first medicament to a subject. One or more (or each) of the at least one first inhaler may, for example, comprise a first medicament reservoir containing the first medicament.

The system also comprises at least one second inhaler. One or more (or each) of the at least one second inhaler is configured to deliver a second medicament to the subject. This may be, for example, the same subject to whom the first medicament is administered via the first inhaler. The first medicament is different from the second medicament. One or more (or each) of the at least one second inhaler may, for example, comprise a second medicament reservoir containing the second medicament.

In a non-limiting example, the first medicament is a rescue medicament for use by the subject as needed, and the second medicament is a maintenance medicament which is used by the subject according to a predetermined treatment regimen.

The rescue medicament is as defined hereinabove and is typically a SABA or a rapid-onset LABA, such as formoterol (fumarate). The rescue medicament may also be in the form of a combination product, e.g. ICS-formoterol (fumarate), typically budesonide-formoterol (fumarate) or beclomethasone (dipropionate)-formoterol (fumarate). Such an approach is termed “MART” (maintenance and rescue therapy).

In a non-limiting example, the first medicament is albuterol (sulfate), and the second medicament is fluticasone (propionate or furoate), or salmeterol (xinafoate) combined with fluticasone (propionate or furoate).

More generally, the first medicament and the second medicament (and any further medicaments included in any further inhalers included in the system) may comprise any suitable active pharmaceutical ingredient. Thus, any class of medication may be delivered by, in other words housed within, the inhalers included in the system. The system permits consolidated handling and communicating of usage information irrespective of the particular medications which are delivered by the inhalers.

One or more (or each) of the at least one first inhaler comprises a first use determination system. The first use determination system is configured to determine a first value of a usage parameter relating to use of the respective first inhaler. The usage parameter may, for instance, comprise a use of, such as an inhalation of the first medicament performed by the subject using, the respective first inhaler. Alternatively or additionally, the usage parameter may comprise a parameter relating to airflow during inhalation of the first medicament performed by the subject.

Similarly, one or more (or each) of the at least one second inhaler comprises a second use determination system. The second use determination system is configured to determine a second value of a usage parameter relating to use of the respective second inhaler. In the case of the second inhaler, the usage parameter may, for instance, comprise a use of, such as an inhalation of the second medicament performed by the subject using, the respective second inhaler. Alternatively or additionally, the usage parameter may comprise a parameter relating to airflow during inhalation of the second medicament performed by the subject.

One or more (or each) of the first inhaler comprises a first transmission module configured to encrypt first data based on the first value, and transmit the encrypted first data. Similarly, one or more (or each) of the second inhaler comprises a second transmission module configured to encrypt second data based on the second value, and transmit the encrypted second data.

The first and second transmission modules may each include an encryption device capable of encrypting the first and second data, respectively. For example, the encryption device may be implemented using hardware such a digital signal processor (DSP), a microcontroller, a processor, and/or the like. The encryption device may be incorporated into other portions of the first and/or second transmission modules, such as a transceiver use to transmit the encrypted data. Examples of different types of transceivers are described in more detail below.

The system comprises a processing module configured to receive the first encrypted data and the second encrypted data from the respective transmission modules.

The processing module may include a general purpose processor, a special purpose processor, a DSP, a microcontroller, an integrated circuit, and/or the like that may be configured using hardware and/or software to perform the functions described herein for the processing module. The processing module may include a power supply and/or a battery.

Encryption of the first and second data in this manner enables transmission of the respective usage parameter values. The encryption may, for instance, further enable such transmission to be effected securely, since decryption of the respective data is implemented by the processing module configured to receive the encrypted data from the respective transmission modules. The processing module may, for example, be paired to the respective transmission modules such that the processing module is configured, e.g. exclusively configured, to decrypt the encrypted data. Thus, such encryption may enable secure transmission of the respective usage parameter values to the processing module, which secure transmission may be preferred in the context of transmission of medical data relating to inhaler usage.

In a non-limiting example, the first and/or second transmission modules are configured to transmit the respective encrypted data wirelessly. A transceiver configured to implement any suitable wireless transmission protocol may be included in the respective transmission modules, such as via Wi-Fi, Wi-MAX, Bluetooth®, Bluetooth® Smart, ZigBee, near field communication (NFC), cellular communication, television white space (TVWS) communication, or any combination thereof.

Although examples described herein may refer to a transceiver, the transceiver may be configured to transmit, but not receive, data (e.g., a transmitter but not a receiver). The transceiver may include one or more semiconductor chips, integrated circuits, and/or the like configured to implement the logic and procedures of the communication protocol. The transceiver may include radio frequency (RF) hardware such as amplifier(s), oscillator(s), modulator circuit(s), antenna(s), antenna tuner(s), and/or the like in order to transmit signals wirelessly using the communication protocol. The RF hardware may be implemented in whole or in part on the semiconductor chip(s), integrated circuit(s), and/or the like configured to implement the logic and procedures of the communication protocol.

Preferably, the data is transmitted from the respective transmission modules to the processing module, and from the processing module to the respective transmission modules via Bluetooth®. Bluetooth® may be preferred because the relatively low energy associated with transmitting and receiving may preserve the battery life of the respective inhaler. Moreover, no internet connection need be established in order for the respective encrypted data to be transmitted to the processing module.

Whilst the respective transmission modules are configured to transmit the encrypted data, in some non-limiting examples the respective transmission modules are further configured to receive data, for example from the processing module to which the encrypted data is sent. In such examples, the respective transmission modules may be regarded as a transceiver, in other words as a transmitting and receiving module.

A clock module may, for example, be included in one or more (or each) of the respective inhalers for assigning a time, for example a time stamp, to the usage parameter of the respective inhaler. The clock module may be implemented via a processor or other type of integrated circuit. The processing module may be configured to synchronize the clock modules of the respective inhalers. One or more (or each) of the respective clock modules may, for instance, receive time data transmitted from the processing module, e.g. via the respective transmission module. Such synchronization may, for instance, provide a point of reference which enables the relative timing of use of the respective inhalers to be determined, which may have clinical relevance. For example, failure to inhale a maintenance medicament during a particular time period in which such an inhalation was or such inhalations were scheduled according to a treatment regimen may be correlated with increased rescue medicament usage towards the end of, or subsequently to, that time period of non-adherence to the treatment regimen. Such diagnostic analysis may be possible when the clock modules of the respective inhalers are synchronized with each other.

Further, it should be appreciated that in some examples, the clock module of an inhaler may operate as an internal counter. When operating as an internal counter, the clock module may provide a relative count (e.g., as opposed to providing a mean solar time, such as a local mean time). For instance, the use determination system of an inhaler may start an internal counter (e.g., which counts up from 0 indefinitely) when, for example, the use determination system is woken out of an energy-saving sleep mode for the first time (e.g., after the mouthpiece cover is opened for the first time). Thereafter, any time-and-date stamp generated by the use determination system may be a relative time (or count) based on the internal counter of the clock module. The use determination system may periodically update the system clock every 250 microseconds (μs).

The processing module may, in some examples, comprise a further clock module. The clock modules of each of the respective inhalers may thus be synchronized according to the time provided by the further clock module. The further clock module may, for instance, receive the time of the time zone in which the processing module is situated. The processing module may, for example, transmit the time of the time zone to the respective clock modules, thereby to permit the clock modules to be synchronized according to the time in which the subject and their respective inhalers are located. Time stamping of the respective usage information may thus correspond to the time of day or night at the subject's geographical location. This is particularly advantageous given the relevance of, for example, night time rescue medicament use to the risk of an impending respiratory disease exacerbation. The system may thus, for example, monitor the day time and night time rescue inhaler usage of a subject who has travelled across time zones. Alternatively or additionally, reminders issued by the system to remind the subject to administer a maintenance medicament may account for the time of day or night at the subject's location.

The processing module is configured to distinguish between the first encrypted data and the second encrypted data. First usage information relating to the first medicament is determined by the processing module based on the distinguished first encrypted data. Similarly, second usage information relating to the second medicament is determined by the processing module based on the distinguished second encrypted data.

In an embodiment, the processing module receives a first identifier assigned to the first medicament. In such an example, a second identifier is assigned to the second medicament. In such an example, the first identifier is not associated with or assigned to the second medicament and the second identifier is not associated with or assigned to the first medicament. The processing module receives the respective identifiers, and uses the respective identifiers to distinguish between the first encrypted data and the second encrypted data.

The respective identifier may, in certain examples, also denote further information, such as the dose strength of each dose delivered by the respective inhaler, for example via a suitable dose metering assembly included in the inhaler. Alternatively or additionally, the respective identifier may denote the total number of doses of the respective medicament contained by the respective inhaler (prior to first use), in other words in the medicament reservoir of the respective inhaler as supplied.

The processing module may, for instance, be accordingly configured to recognize the dose strength and/or the total number of doses which can be provided by the respective inhaler from the respective identifier. Moreover, when the respective identifier denotes the dose strength, the processing module may be configured to, for example, control the user interface to issue a notification that the label recommended dosages have been exceeded based on the respective usage information, in this case uses of the respective inhaler, and the respective dose strength.

In some examples in which a further inhaler configured for dispensing a medicament is added to the system which already includes an existing inhaler which dispenses the same medicament, the processing module may be configured to determine, based on the respective identifiers for the existing inhaler and the further inhaler whether the dose strength of the further inhaler is the same as or different from that of the existing inhaler. If the respective dose strengths are different from each other, the processing module controls a user interface to issue at least one notification. The at least one notification may, for example, comprise a notification informing the subject that the dose strength of the further inhaler is different from that of the existing inhaler and/or a notification to request that the subject discards the existing inhaler. In this manner, the system may assist the subject to adjust to a prescription change. The medicament in this example may be a rescue medicament or a maintenance medicament.

When the respective identifier denotes the total number of doses contained by the respective inhaler, the processing module may be configured to control the user interface to issue a notification that the respective inhaler should be replaced based on the respective usage information, in this case uses of the respective inhaler, and the respective total number of doses as denoted by the respective identifier. For instance, subtraction of the number of uses of the respective inhaler as determined via the use determination system from the total number of doses denoted by the respective identifier will provide the number of doses remaining in the respective inhaler. The notification may be triggered by the processing module when the determined number of doses remaining in the respective inhaler reaches or becomes lower than a predetermined threshold number of doses.

In a non-limiting example, the first identifier is included in a first key which is used to pair the first inhaler and the processing module. The processing module is configured to identify the first inhaler as an inhaler which delivers the first medicament on the basis of the first identifier included in the first key. Similarly, the second identifier may be included in a second key for pairing the second inhaler and the processing module, and the processing module identifies the second inhaler as an inhaler which delivers the second medicament on the basis of the second identifier included in the second key. In this manner, the first encrypted data is linked to the first medicament, and the second encrypted data is linked to the second medicament.

More generally, by the processing module distinguishing between the first encrypted data and the second encrypted data, the first encrypted data relating to administering of the first medicament is processed separately from the second encrypted data relating to administering of the second medicament. Because the first and second medicaments are different from each other, and thus may each be associated, for instance, with distinct treatment regimens and/or administration protocols, this separate data processing may advantageously ensure that the first usage information relating to the first medicament does not become conflated with the second usage information relating to the second medicament. The system nevertheless permits consolidated handling and communicating of the first and second usage information.

The processing module is configured to control the user interface to communicate, for example display, the first and second usage information. In this way, the subject is informed of their usage of the first and second medicaments respectively. In the case of the first or second medicament being, for instance, a rescue medicament, the system may enable the subject to track the status of their respiratory disease. In the case of the first or second medicament being, for example, a maintenance medicament, the system may enable the subject to track their adherence to, or compliance with, a predetermined treatment regimen. In some examples, the processing module is configured to control the user interface to display the first and second usage information simultaneously, such as in a single graphical user interface (GUI).

In an embodiment, the system further comprises at least one third inhaler. One or more (or each) of the at least one third inhaler is configured to deliver a third medicament to the subject. This may be, for example, the same subject to whom the first and second medicaments are administered via the first inhaler and the second inhaler respectively. The third medicament is different from the first and second medicaments. One or more (or each) of the at least one third inhaler may, for example, comprise a third medicament reservoir containing the third medicament.

One or more (or each) of the at least one third inhaler comprises a third use determination system configured to determine a third value of a usage parameter relating to use of the respective third inhaler. The usage parameter may, for instance, comprise a use of, such as an inhalation of the third medicament performed by the subject using, the respective third inhaler. Alternatively or additionally, the usage parameter may comprise a parameter relating to airflow during inhalation of the third medicament performed by the subject.

In a non-limiting example, the first medicament is a rescue medicament for use by the subject as needed, the second medicament is a maintenance medicament which is used by the subject according to a predetermined treatment regimen, and the third medicament is a further maintenance medicament which is used by the subject according to a further predetermined treatment regimen.

In a non-limiting example, the first medicament is albuterol (sulfate), and the second medicament is salmeterol (xinafoate) combined with fluticasone (propionate or furoate), budesonide combined with formoterol (fumarate), or beclomethasone (dipropionate).

The third inhaler further comprises a third transmission module configured to encrypt third data based on the third value, and transmit the encrypted third data. The processing module is further configured to receive the third encrypted data, and distinguish the third encrypted data from the encrypted data transmitted from the respective transmission modules included in the other inhalers included in the system. The processing module determines third usage information relating to the third medicament from the distinguished third encrypted data.

The third transmission module may, for example, be configured to provide a third identifier assigned to the third medicament. In this example, the processing module is configured to receive the third identifier, and use the first, second, and third identifiers to distinguish the third encrypted data from the first and second encrypted data. The third identifier may, in certain examples, also denote further information, such as the dose strength and/or the total number of doses of the third medicament contained by the third inhaler, in other words in the third medicament reservoir of the third inhaler.

In a non-limiting example, the third identifier is included in a third key which is used to pair the third inhaler and the processing module. The processing module is configured to identify the third inhaler as an inhaler which delivers the third medicament on the basis of the third identifier included in the third key, as previously described in relation to the first and second inhalers.

More generally, the third encrypted data relating to administering of the third medicament is processed separately from the first and second encrypted data relating to administering of the first and second medicaments. Because the first, second, and third medicaments are different from each other, and thus may each be associated, for instance, with distinct treatment regimens and/or administration protocols, this separate data processing may advantageously ensure that the third usage information relating to the third medicament does not become conflated with the first and second usage information relating to the first and second medicaments. The system nevertheless permits consolidated handling of the first, second, and/or third usage information. In this respect, the processing module controls the user interface to communicate, for example display, the first, second, and/or third usage information.

In some non-limiting examples, the system comprises two or more first inhalers, such as two, three, four, five, or more first inhalers. Such a plurality of first inhalers may be particularly advantageous when, for example, the first medicament is a rescue medicament. In such an example, the subject may place first inhalers in various different locations, such as on a nightstand, in a gym bag, in a vehicle, and so on, in order that the rescue medicament is readily available if needed.

In other non-limiting examples, the first medicament is a maintenance medicament. In such an example, the subject may place first inhalers in various different locations in order to facilitate administration of the maintenance medicament at points during the subject's daily routine, thereby assisting the subject to adhere to the treatment regimen associated with the maintenance medicament.

In a non-limiting example, the first identifier is the same for all of the plurality of first inhalers. Whilst the plurality of first inhalers may, for instance, each have a first key which is different from the other first inhalers (and that of the second inhaler(s) and, when present, that of the third inhaler(s)), each of the first keys comprise the first identifier. In this way, the first encrypted data is linked to the first medicament irrespective of the fact that several first inhalers may be being used by the subject. The system thus permits tracking of use of the first medicament in spite of the latter being administered via a plurality of first inhalers.

Similar considerations are applicable to the at least one second inhaler, and, when present, the at least one third inhaler. In other words, the at least one second inhaler may comprise two or more second inhalers. Alternatively or additionally, the at least one third inhaler may comprise two or more third inhalers.

More generally, the system may, for example, comprise a fourth inhaler, a fifth inhaler, and so on. The first, second, third, fourth, fifth, etc. inhalers may dispense a different medicament from the others. In a non-limiting example, the respective medicaments are: albuterol; salmeterol combined with fluticasone; fluticasone; beclomethasone combined with albuterol; budesonide combined with formoterol.

In some non-limiting examples, at least one of the respective medicaments is a LAMA, such as those identified hereinabove.

Further provided is a method comprising receiving first encrypted data from a first transmission module of a first inhaler configured to deliver a first medicament to a subject. The first encrypted data is based on a first value of a usage parameter relating to use of the first inhaler, e.g. as determined by a first use determination system included in the first inhaler. The method also comprises receiving second encrypted data from a second transmission module included in a second inhaler configured to deliver a second medicament to the subject. The second encrypted data is based on a second value of a usage parameter relating to use of the second inhaler, e.g. as determined by a second use determination system included in the second inhaler. The second medicament is different from the first medicament. The first encrypted data and the second encrypted data are distinguished from each other. First usage information relating to the first medicament is determined from the distinguished first encrypted data. Second usage information relating to the second medicament is determined from the distinguished second encrypted data. The method further comprises controlling a user interface to communicate, for example display, the first and second usage information.

A computer program is also provided, which computer program comprises computer program code which is adapted, when the computer program is run on a computer, to implement the method.

The embodiments described herein for the system are applicable to the method and the computer program. Moreover, the embodiments described for the method and computer program are applicable to the system.

FIG.1shows a block diagram of an inhaler100according to an example. The inhaler100comprises a use determination system12which determines at least one value of a usage parameter. The at least one value of the usage parameter is received by a transmission module14, as represented inFIG.1by the arrow between the block representing the use determination system12and the block representing the transmission module14. The transmission module14encrypts data based on the value(s) of the usage parameter, and transmits the encrypted data, as represented inFIG.1by the arrow pointing away from the transmission module14block. The transmission of the encrypted data by the transmission module14may, for example, be wireless, as previously described.

The usage parameter may, for example, comprise a use of the respective inhaler. In a relatively simple implementation, the at least one value may comprise “TRUE” when use of, for example an inhalation using, the respective inhaler has been determined, or “FALSE” when no such use of the respective inhaler is determined.

The use determination system12may include one or more components used to determine at least one value of a usage parameter of inhaler100. The usage parameter may be one or more of a count of the number of uses inhaler100, a measure of airflow of inhaler100, and/or other measurements indicating the usage of the medicament of inhaler100. The use determination system12may include one or more of a switch configured to detect usage of inhaler100, one or more sensors configured to detect use of inhaler100, one or more buttons configured to be depressed upon use of inhaler100, and/or the like.

For example, the use determination system12may, for instance, comprise a mechanical switch configured to be actuated prior to, during, or after use of the respective inhaler. The mechanical switch may indicate that a dose of medicament has been primed and is ready for inhalation (e.g., such as by metering a dose from a hopper, advancing and/or opening a blister pack, etc.). In a non-limiting example, the inhaler100comprises a medicament reservoir (not visible inFIG.1), and a dose metering assembly (not visible inFIG.1) configured to meter a dose of the rescue medicament from the reservoir. The use determination system12may be configured to register the metering of the dose by the dose metering assembly, each metering being thereby indicative of the inhalation performed by the subject using the inhaler100. Accordingly, the inhaler100may be configured to monitor the number of inhalations of the medicament, since the dose should be metered via the dose metering assembly before being inhaled by the subject. One non-limiting example of the dose metering assembly will be explained in greater detail with reference toFIGS.12-16.

Alternatively or additionally, the use determination system12may register each inhalation in different manners and/or based on additional or alternative feedback. For example, the use determination system12is configured to register an inhalation by the subject when the feedback from a suitable sensor (not visible inFIG.1) indicates that an inhalation by the subject has occurred, for example when a pressure measurement or flow rate exceeds a predefined threshold associated with a successful inhalation.

A sensor, such as a pressure sensor or acoustic sensor, may, for example, be included in the use determination system12in order to register each inhalation. Such a sensor may be an alternative or in addition to the abovementioned mechanical switch. When a pressure or acoustic sensor is included in the use determination system12, the pressure sensor may, for instance, be used to confirm that, or assess the degree to which, a dose metered via the dose metering assembly is inhaled by the subject, as will be described in greater detail with reference toFIGS.2and12-16.

More generally, the use determination system12may comprise a sensor for detecting a parameter relating to airflow during inhalation of the respective medicament performed by the subject. In other words, the usage parameter comprises a parameter relating to airflow during inhalation of the medicament. The at least one value may thus, for example, comprise a numerical value relating to the detected inhalation parameter.

The inhalation parameter may be, for example, at least one of a peak inhalation flow, an inhalation volume, a time to peak inhalation flow, and an inhalation duration. In such examples, the at least one value comprises a numerical value for the peak inhalation flow, the inhalation volume, the time to peak inhalation flow, and/or the inhalation duration.

A pressure sensor may be particularly suitable for measuring the parameter, since the airflow during inhalation by the subject may be monitored by measuring the associated pressure changes. As will be explained in greater detail with reference toFIGS.12-16, the pressure sensor may be located within or placed in fluid communication with a flow pathway through which air and the medicament is drawn by the subject during inhalation. Alternative ways of measuring the parameter, such as via a suitable flow sensor, can also be used.

An inhalation may be associated with a decrease in the pressure in the airflow channel of the inhaler relative to when no inhalation is taking place. The point at which the pressure change is at its greatest may correspond to the peak inhalation flow. The pressure sensor may detect this point in the inhalation.

The pressure change associated with an inhalation may alternatively or additionally be used to determine an inhalation volume. This may be achieved by, for example, using the pressure change during the inhalation measured by the pressure sensor to first determine the flow rate over the time of the inhalation, from which the total inhaled volume may be derived.

The pressure change associated with an inhalation may alternatively or additionally be used to determine an inhalation duration. The time may be recorded, for example, from the first decrease in pressure measured by the pressure sensor, coinciding with the start of the inhalation, to the pressure returning to a pressure corresponding to no inhalation taking place.

The inhalation parameter may alternatively or additionally include the time to peak inhalation flow. This time to peak inhalation flow parameter may be recorded, for example, from the first decrease in pressure measured by the pressure sensor, coinciding with the start of the inhalation, to the pressure reaching a minimum value corresponding to peak flow.

FIG.2shows a graph of flow rate16versus time18during use of an inhaler100according to a non-limiting example. The use determination system12in this example comprises a mechanically operated switch in the form of a switch which is actuated when a mouthpiece cover of the inhaler100is opened. The mouthpiece cover is opened at point20on the graph. In this example, the use determination system12further comprises a pressure sensor.

When the mouthpiece cover is opened, the use determination system12is woken out of an energy saving sleep mode, and a new inhalation event is registered. The inhalation event is also assigned an open time corresponding to how much time, for example milliseconds, elapses since the inhaler100wakes from the sleep mode. Point22corresponds to the cap closing or 60 seconds having elapsed since point20. At point22, detection ceases.

Once the mouthpiece cover is open, the use determination system12looks for a change in the air pressure, as detected using the pressure sensor. The start of the air pressure change is registered as the inhale event time24. The point at which the air pressure change is greatest corresponds to the peak inhalation flow26. The use determination system12records the peak inhalation flow26as a flow of air, measured in units of 100 mL per minute, which flow of air is transformed from the air pressure change. Thus, in this example, the at least one value comprises a value of the peak inhalation flow in units of 100 mL per minute. The corresponding usage information provided via the user interface may, for example, express this peak inhalation flow using the same units or in liters per minute.

The time to peak inhalation flow28corresponds to the time taken in milliseconds for the peak inhalation flow26to be reached. The inhalation duration 30 corresponds to the duration of the entire inhalation in milliseconds. The area under the graph32corresponds to the inhalation volume in milliliters.

The usage information provided via the user interface may, additionally or alternatively to providing the inhalation parameter(s) as numerical values, provide a classification of one or more (or each) inhalation event(s). For example, if the peak inhalation flow is between 0 and 30 liters per minute, the inhalation event is classified as “low inhalation” (less than or equal to 30 liters per minute) or as “no inhalation”, if no inhalation is detected within 60 seconds of the mouthpiece cover being open. If the peak inhalation flow is greater than 45 and less than or equal to 200 liters per minute, the inhalation event is classified as a “good inhalation”. If the peak inhalation flow is greater than 30 and less than or equal to 45 liters per minute, the inhalation event is classified as “fair”. If the peak inhalation flow is above 200 liters per minute, the inhalation event is classified as a “possible air vent block”. The inhalation event may be classified as an “exhalation”, which may be sensed by airflow being detected in the opposite direction to that expected for inhalation using the inhaler100.

In a non-limiting example, the inhaler is configured such that, for a normal inhalation, the medicament is dispensed approximately 0.5 seconds following the start of the inhalation. A subject's inhalation only reaching peak inhalation flow after the 0.5 seconds have elapsed, such as after approximately 1.5 seconds, may be partially indicative of the subject having difficulty in controlling their respiratory disease. Such a time to reach peak inhalation flow may, for example, be indicative of the subject facing an impending exacerbation.

More generally, the use determination system12may employ respective sensors (e.g. respective pressure sensors) for registering an inhalation/use of the inhaler and detecting the inhalation parameter, or a common sensor (e.g. a common pressure sensor) which is configured to fulfil both inhalation/use registering and inhalation parameter detecting functions.

Any suitable sensor may be included in the use determination system12, such as one or more pressure sensors, temperature sensors, humidity sensors, orientation sensors, acoustic sensors, and/or optical sensors. The pressure sensor(s) may include a barometric pressure sensor (e.g. an atmospheric pressure sensor), a differential pressure sensor, an absolute pressure sensor, and/or the like. The sensors may employ microelectromechanical systems (MEMS) and/or nanoelectromechanical systems (NEMS) technology.

In a non-limiting example, the use determination system12comprises a differential pressure sensor. The differential pressure sensor may, for instance, comprise a dual port type sensor for measuring a pressure difference across a section of the air passage through which the subject inhales. A single port gauge type sensor may alternatively be used. The latter operates by measuring the difference in pressure in the air passage during inhalation and when there is no flow. The difference in the readings corresponds to the pressure drop associated with inhalation.

In another non-limiting example, the use determination system12includes an acoustic sensor. The acoustic sensor in this example is configured to sense a noise generated when the subject inhales through the respective inhaler100. The acoustic sensor may include, for example, a microphone. The respective inhaler100may, for instance, comprise a capsule which is arranged to spin when the subject inhales though the device; the spinning of the capsule generating the noise for detection by the acoustic sensor. The spinning of the capsule may thus provide a suitably interpretable noise, e.g. rattle, for deriving use and/or inhalation parameter data.

An algorithm may, for example, be used to interpret the acoustic data in order to determine use data and/or the parameter relating to airflow during the inhalation. For instance, an algorithm as described by P. Colthorpe et al., “Adding Electronics to the Breezhaler: Satisfying the Needs of Patients and Regulators”, Respiratory Drug Delivery 2018, 1, 71-80 may be used. Once the generated sound is detected, the algorithm may process the raw acoustic data to generate the use and/or inhalation parameter data.

FIG.3shows a block diagram of a system10according to a non-limiting example. The system10may, for example, be alternatively termed “an inhaler assembly”.

As shown inFIG.3, the system10comprises a first inhaler100A comprising a first use determination system12A, and a first transmission module14A. The system10further comprises a second inhaler100B comprising a second use determination system12B, and a second transmission module14B. The first inhaler100A delivers a first medicament, and the second inhaler100B delivers a second medicament which is different from the first medicament, as previously described.

Whilst not essential in the context of the present disclosure, the system10depicted inFIG.3further comprises a third inhaler100C comprising a third use determination system12C, and a third transmission module14C. The third inhaler100C delivers a third medicament which is different from the first and second medicaments. In other examples, no third inhaler100C is included in the system10, or a fourth, fifth, etc. inhaler (not visible) is included in addition to the first inhaler100A, the second inhaler1008, and the third inhaler100C. Alternatively or additionally, the system10includes a plurality of first inhalers100A, a plurality of second inhalers1008, and so on, as previously described.

The system10comprises a processing module34which is configured to receive the respective encrypted data transmitted from each of the transmission modules14A,14B,14C, as represented inFIG.3by the arrows between each of the blocks corresponding to the transmission modules14A,14B,14C and the block corresponding to the processing module34. The first, second, and/or third encrypted data may be transmitted wirelessly to the processing module34, as previously described. The processing module34may thus comprise a suitable receiver or transceiver for receiving the encrypted data. The receiver or transceiver of processing module34may be configured to implement the same communication protocols as transmission modules14A,14B,14C and may thus include similar communication hardware and software as transmission modules14A,14B,14C as described herein (not shown inFIG.3).

The processing module34may comprise a suitable processor and memory configured to perform the functions described herein for the processing module. For example, the processor may be a general purpose processor programmed with computer executable instructions for implementing the functions of the processing module. The processor may be implemented using a microprocessor or microcontroller configured to perform the functions of the processing module. The processor may be implemented using an embedded processor or digital signal processor configured to perform the functions of the processing module. In an example, the processor may be implemented on a smartphone or other consumer electronic device that is capable of communicating with transmission modules14A,14B,14C and performing the functions of the processing module34as described herein. For example, the processing module may be implemented on a smart phone or consumer electronic device that includes an application (e.g., app) that causes the processor of the smartphone or other consumer electronic device to perform the functions of the processing module34as described herein.

The processing module34distinguishes between the first encrypted data, the second encrypted data, and the third encrypted data, for example by using respective identifiers, as previously described.

The processing module34determines first usage information relating to the first medicament based on the distinguished first encrypted data. The first usage information may comprise a registered use of, or inhalation performed using, the first inhaler100A, and/or a parameter relating to airflow during such an inhalation using the first inhaler100A, as previously described.

Similarly, the processing module34determines second and third usage information relating to the second and third medicaments respectively, based on the distinguished second and third encrypted data.

The system10further comprises a user interface38. The processing module34is configured to control the user interface38to communicate the first, second, and/or third usage information. The arrow pointing from the block representing the processing module34to the block representing the user interface38is intended to represent the control signal(s) which causes or cause the user interface to communicate, for example display, the respective usage information. In this respect, the user interface38may comprise any suitable display, screen, for example touchscreen, etc. which is capable of displaying the respective usage information. Alternatively or additionally, the respective usage information may be provided by the user interface38via an audio message. In such an example, the user interface38comprises a suitable loudspeaker for delivering the audio message. Numerous ways of communicating the respective usage information can be used.

The system10thus enables the subject to be informed of their usage of the respective medicaments, which may be administered according to a treatment regimen and/or an administration protocol specific to the respective medicament, as previously described.

Whilst the transmission modules14A,14B,14C are each shown inFIG.3as transmitting (encrypted) data to the processing module34, this is not intended to exclude the respective inhalers100A,1008,100C, or a component module thereof, receiving data transmitted from the processing module34.

In a non-limiting example, a clock module (not visible in the Figures) is included in each of the respective inhalers100A,1008,100C for assigning a time, for example a time stamp, to the usage parameter of the respective inhaler100A,1008,100C. In this example, the processing module34is configured to synchronize the clock modules of the respective inhalers100A,1008,100C. Such synchronization may, for instance, provide a point of reference which enables the relative timing of use of the respective inhalers100A,1008,100C to be determined, which may have clinical relevance, as previously described. The assigned time, for example time stamp, may, for instance, be included in the usage information for the respective medicaments communicated, e.g. displayed, by the user interface38.

Whilst not shown inFIG.3, the processing module34may, in some examples, comprise a further clock module. The clock modules of each of the respective inhalers100A,1008,100C may thus be synchronized according to the time provided by the further clock module. The further clock module may, for instance, receive the time of the time zone in which the processing module34is situated. This may cause the respective inhalers100A,1008,100C to be synchronized according to the time in which the subject and their respective inhalers100A,1008,100C are located, which may provide further information of clinical relevance, as previously described.

In an embodiment, the processing module34is at least partly included in a first processing module included in the user device40. By implementing as much processing as possible of the usage data from the respective inhalers100A,1008,100C in the first processing module of the user device40, battery life in the respective inhalers100A,1008,100C may be advantageously saved. The user device40may be, for example, at least one selected from a personal computer, a tablet computer, and a smart phone.

Alternatively or additionally, the user interface38may be at least partly defined by a first user interface of the user device40. The first user interface of the user device40may, for instance, comprise, or be defined by, the touchscreen of a smart phone40.

In other non-limiting examples, the processing module is not included in a user device. The processing module (or at least part of the processing module34) may, for example, be provided in a server, e.g. a remote server.

FIGS.4A-4Bshow front and rear views, respectively, of the exterior of an inhaler100according to a non-limiting example. The inhaler100comprises a top cap102, a main housing104, a mouthpiece106, a mouthpiece cover108, and an air vent126. The mouthpiece cover108may be hinged to the main housing104so that it may open and close to expose the mouthpiece106and the air vent126. The depicted inhaler100also comprises a mechanical dose counter111, whose dose count may be used to check the number of doses remaining as determined by the processing module (on the basis of the total number of doses contained by the inhaler100prior to use and on the uses determined by the use determination system12), as previously described.

In the non-limiting example shown inFIGS.4A-4B, the inhaler100has a barcode42printed thereon. The barcode42in this example is a quick reference (QR) code printed on the uppermost surface of the top cap102. The use determination system12and/or the transmission module14may, for example, be located at least partly within the top cap102, for example as components of an electronics module (not visible inFIGS.4A-4B). The electronics module of the inhaler100will be described in greater detail with reference toFIGS.12to15.

The QR code is more clearly visible inFIG.5, which provides a view from directly above the top cap102of the inhaler100shown inFIGS.4A-4B. The QR code42may provide a facile way of pairing the respective inhaler100with the processing module34, in examples in which the user device40comprises a suitable optical reader, such as a camera, for reading the QR code.FIG.6shows a user pairing the inhaler100with the processing module34using the camera included in the user device40, which in this particular example is a smart phone.

Such a bar code42, e.g. QR code, may comprise the identifier which is assigned to the respective medicament of the inhaler100, as previously described. Table 1 provides a non-limiting example of the identifiers included in the QR code42for various inhalers100.

TABLE 1TotaldoseDosecount ofMedicamentIdentifierBrand ofstrengthinhaleridentificationin QR codeinhalerMedicament(mcg)prior to usenumber<blank>ProAiralbuterol117200AAA200DigihalerAAA030ProAiralbuterol11730AAA030DigihalerFSL060AirDuofluticasone/55/1460FSL060DigihalersalmeterolFSM060AirDuofluticasone/113/1460FSM060DigihalersalmeterolFSH060AirDuofluticasone/232/1460FSH060DigihalersalmeterolFPL060ArmonAirfluticasone5560FPL060DigihalerFPM060ArmonAirfluticasone11360FPM060DigihalerFPH060ArmonAirfluticasone23260FPH060Digihaler

As shown in Table 1, the identifier further denotes the dose strength and the total dose count of the inhaler prior to use. The processing module34may use the former to, in combination with the usage information, control the user interface38to issue a notification when the label recommended dosages have been exceeded, as previously described. Alternatively or additionally, the processing module34may use the total dose count of the inhaler prior to use and the usage information to determine the number of doses remaining in the respective inhaler100, as previously described.

The barcode42, e.g. QR code, on the inhaler may, for instance, further comprise a security key, for example in the form of a series of alphanumerical characters, for preventing unauthorized users from accessing the respective inhaler100. The processing module34may be able to decrypt the respective encrypted data once the processing module34has been provided with the security key, but may not be able to decrypt the respective encrypted data before the processing module34has been provided with the security key. More generally, the security key may be included in the respective identifier.

In a non-limiting example, the system is configured to restrict one or more, e.g. each, of the inhalers included in the system to a single user account.

In such an example, a passkey, e.g. provided in the QR code, may allow synchronization between the respective inhaler and the processing module of the system. The passkey and, in turn, the usage parameter data, e.g. inhalation and/or usage data, from the respective inhaler may be public. This public inhalation data may not be associated with the particular subject until synchronization with the single user account.

Since the system is configured to restrict the respective inhaler to being associated with the single user account, the respective inhaler may be prevented from being synchronized with another user account, for example in situations where the inhaler is lost or stolen. In this way, third parties may be prevented from acquiring usage parameter data which is not theirs.

In other non-limiting examples, the processing module34may be paired with the respective inhaler100by, for example, manual entry of an alphanumerical key including the respective identifier via the user interface, e.g. a touchscreen.

FIG.7provides a flowchart of a method50according to an example. The method50comprises receiving52first encrypted data from a first transmission module of a first inhaler configured to deliver a first medicament to a subject. The first encrypted data is based on a first value of a usage parameter relating to use of the first inhaler determined by a first use determination system included in the first inhaler, as previously described.

Second encrypted data is received54from a second transmission module included in a second inhaler configured to deliver a second medicament to the subject. The second encrypted data is based on a second value of a usage parameter relating to use of the second inhaler. The second medicament is different from the first medicament;

The method further comprises distinguishing56between the first encrypted data and the second encrypted data, and determining58first usage information relating to the first medicament from the distinguished first encrypted data. Second usage information relating to the second medicament is determined60from the distinguished second encrypted data. A user interface is controlled62to display the first and second usage information. As one non-limiting examples, the user interface may display a GUI that displays the first and second usage information, for example, simultaneously in a single GUI.

In an embodiment, the receiving52the first encrypted data comprises receiving the first encrypted data from each respective first transmission module of a plurality of first inhalers, each of said plurality of first inhalers being configured to deliver the first medicament.

Alternatively or additionally, the receiving54the second encrypted data may comprise receiving the second encrypted data from each respective second transmission module of a plurality of second inhalers, each of said plurality of second inhalers being configured to deliver the second medicament.

Whilst not shown inFIG.7, the method50may further comprise receiving third encrypted data from a third transmission module included in a third inhaler configured to deliver a third medicament which is different from the first and second medicaments. In such an example, the method50comprises distinguishing the third encrypted data from the first encrypted data and the second encrypted data, and determining third usage information relating to the third medicament from the distinguished third encrypted data. The user interface is controlled to display the third usage information.

The method50may comprise receiving identifiers, each identifier being assigned according to the medicament which is delivered by the respective inhaler. The respective identifiers may then be used to distinguish56the respective encrypted data, as previously described.

A clock module may, for instance, be included in each of the respective inhalers for assigning a time to said usage parameter of the respective inhaler. In such an example, the method50further comprises synchronizing the clock modules of the respective inhalers. The time assigned to the usage parameter may, for example, be included in the usage information for the respective medicaments. The synchronizing may in some examples comprise synchronizing each of the respective clock modules with the time of the time zone in which the respective inhalers are situated, as previously described.

In a non-limiting example, the processing module determines a use and/or system error based on the encrypted data received from one or more, e.g. each, of the inhalers included in the system. Such a use error may, for example, be indicative of potential misuse of the respective inhaler or inhalers. The system error may be indicative of a fault with a component of the respective inhaler, such as the use determination system and/or the transmission module of the respective inhaler. A system error may, for example, include a hardware fault of the respective inhaler. The user interface may be controlled by the processing module to provide an alert or notification based on the determined use and/or system error (e.g., such as providing an alert or notification for the determined use and/or system errors of each of a plurality of different inhalers, potentially including different medicaments).

A use error may, for example, include a low inhalation event, a no inhalation event, and/or an excessive inhalation event. Such events will be described in more detail below with reference toFIG.16.

A use error may alternatively or additionally include one or more of: the mouthpiece cover being left open for more than a predetermined time period, e.g. 60 seconds; multiple inhalations being recorded in respect of a single actuation of the above-described mechanical switch, for example a second inhalation performed within the same mouthpiece cover open/closed session; and an exhalation through the flow pathway, as determined from a positive pressure change being sensed in the flow pathway.

When the use error relates to the mouthpiece cover being left open for more than the predetermined time period, the inhalers detection circuitry may only stay active for the predetermined time period to preserve battery life. This may mean that anything which would otherwise be detectable/determinable by the use determination system that occurs outside of this predetermined time period is not detected/recorded. Notifying the user of this error may therefore serve the purpose of informing the user that otherwise detectable events are not detected outside the predetermined time period triggered by opening of the mouthpiece cover.

It is noted that the abovementioned exhalation-based use error may not be recorded if such an exhalation is sensed subsequently to an inhalation being performed in respect of a given actuation of the mechanical switch, e.g. within the same mouthpiece cover open/closed session.

System errors may include one or more of: a problem occurring when saving inhalation data to a memory included in the inhaler, such as a memory included in the use determination system (“corrupted data error”); an error with the clock module of the inhaler (“time stamp error”); and an error relating to collecting information about the inhalation (“inhalation parameter error”).

In a particular example, use and/or system errors from more than one, e.g. all of, the inhalers included in the system are collected, e.g. aggregated, by the processing module. The processing module is further configured to control the user interface to provide the alert or notification based on the collected use and/or system errors. For instance, the processing module controls the user interface to provide the alert or notification based on the number of use and/or system errors collected from the inhalers included in the system reaching or exceeding a predetermined number of use and/or system errors.

As shown inFIG.8, the present disclosure further provides a method70comprising adding72a further inhaler configured to dispense a medicament to a system comprising a processing module, a user interface, and an existing inhaler which is also configured to dispense the medicament. The further inhaler includes a (further) use determination system and a (further) transmission module, and the existing inhaler includes an existing use determination system and an existing transmission module. Such use determination systems and transmission modules have already been described above, so a further description here will be omitted for the sake of brevity only.

The method70comprises receiving74an identifier provided with the further inhaler, for example via a barcode, such as a QR code, printed on the further inhaler or its packaging, as previously described. The identifier denotes at least the medicament and the dose strength of the medicament. The method further comprises using76the processing module to control the user interface to issue at least one notification if the dose strength of the medicament in the further inhaler as denoted by the identifier is different from the dose strength of the medicament in the existing inhaler.

The at least one notification may, for example, comprise a notification informing the subject that the dose strength of the further inhaler is different from that of the existing inhaler and/or a notification to request that the subject discards the existing inhaler. In this manner, the system may assist the subject to adjust to a prescription change.

The present disclosure further provides a method comprising determining whether a medicament of a further inhaler which is added to a system, which system comprises a processing module, a user interface, and an existing inhaler which delivers a maintenance medicament, is a further maintenance medicament.

The further inhaler includes a (further) use determination system and a (further) transmission module, and the existing inhaler includes an existing use determination system and an existing transmission module. Such use determination systems and transmission modules have already been described above, so a further description here will be omitted for the sake of brevity only.

The determination of whether the medicament is a further maintenance medicament may, for example, be based on an identifier which identifies that the further medicament is a maintenance medicament or is a different medicament type, such as a rescue medicament. The identifier may be received by the processing module of the system, and the processing module may implement the determination. Such an identifier may, for example, be included in a QR code of the further inhaler, as previously described.

If the medicament is identified as a further maintenance medicament, the method may further comprise controlling the user interface to prompt the user to select one of the existing inhaler and the further inhaler. Reminders may then be issued, e.g. by the processing module controlling the user interface to provide such reminders, according to the user selection to remind the subject to use the existing inhaler or the further inhaler according to a treatment regimen relating to administering of the maintenance medicament or the further maintenance medicament respectively.

In this manner, the method (or the system which is configured to implement the method) may limit such reminders to one maintenance inhaler. In other words, for instances where the subject is prescribed multiple maintenance inhalers, the user selection may cause the system to provide reminders for the selected maintenance inhaler, but not provide reminders for the maintenance inhaler which was not selected. The subject or user may select the particular maintenance inhaler based on the specific or current treatment regimen of the subject.

Alternatively or additionally, the method may comprise, based on the determination that the medicament is a further maintenance medicament, providing an alert, e.g. via the user interface and/or by transmitting a notification to a healthcare provider, that the system comprises both the maintenance medicament and the further maintenance medicament.

Such an alert may, for example, comprise a message informing the user or subject to verify with their healthcare provider (and/or doctor) that a plurality of maintenance medicaments are prescribed for the subject.

Such an example may be applicable when, for instance, the subject is prescribed two maintenance medicaments at the same time, e.g. when the subject is transitioning between maintenance treatments. When the further inhaler is added to the system, for example when the QR code of the further inhaler is scanned, the processing module may be configured to provide the alert, e.g. by controlling the user interface and/or by transmitting the alert to the subject's healthcare provider.

Also provided is a computer program comprising computer program code which is adapted, when the computer program is run on a computer, to implement any of the above-described methods. In a preferred embodiment, the computer program takes the form of an app, for example an app for a user device40, such as a mobile device, e.g. tablet computer or a smart phone.

FIG.9provides a first view of a user interface38according to a non-limiting example. In this example, the user interface38comprises the screen of a smart phone, which smart phone defines the user device40. Symbol81denotes the signal strength of the cellular signal being received by the smart phone40. Symbol82denotes that the smart phone40is connected to WiFi. The time83provided by the (further) clock module included in the processing module34of the smart phone40. This time83may be used to synchronize the respective clock modules of the inhalers100A,100B included in the system10, as previously described.

The battery life84of the user device40is also displayed by the user interface38. Symbol85indicates that Bluetooth® is enabled. At least one of the cellular signal81, WiFi82, and Bluetooth® 84 may be used to communicate with the respective inhaler100A,100B. Bluetooth® may be preferred, as previously explained.

The screenshot view80A provided inFIG.9may be regarded as a “splash screen” which is presented while the app is being launched. Box86denotes the position of a logo relating to the respective inhaler100A,1008and/or app provider.

FIG.10provides a second view80B of the user interface38. In this screenshot view80B, the logo86is accompanied by details of the inhalers100A,1008,100C supported by the app. Box87includes text and/or figures communicating that the app supports the inhalers100A,1008,100C. Box88denotes the first inhaler100A, box89denotes the second inhaler1008, and box90denotes the third inhaler100C, although the provision of more than two inhalers100is non-essential in the context of the present disclosure.

Box91provides a message for the subject to study safety information and full prescribing information in a relevant section of the app.

FIG.11provides a third view of the user interface38. This screenshot view80C provides touch points and information relating to usage of the respective inhalers100A,1008,100C. Box91is a touchpoint which enables the subject to view the connectivity status, e.g. Bluetooth® connectivity status, of the respective inhalers100A,1008,100C.

Box93may provide an alert, reminder and/or notification. For instance, box93may contain a text or pictorial reminder for the subject to administer a maintenance medicament.

Box94A may provide a salutation to the subject, for example using the time of the day associated with the time83. Box94B provides the date.

Box95provides environment information at the subject's location, such as weather, temperature, and/or humidity information. Such information may have relevance to the subject's management of their respiratory disease. The processing module34may be configured to retrieve such environment information, for example from a suitable third party internet source, and control the user interface34to display the retrieved environment information.

Box96A provides first usage information relating to use of the first inhaler100A. For example, the subject may be informed of registered uses of the first inhaler100A during the day thus far, during the past 7 days, during the past 30 days, and so on. The box96A may also provide a reminder to the subject to administer the first medicament at a certain point in the future.

Similarly, box96B provides second usage information relating to use of the second inhaler1008. The subject may, for example, be informed of registered uses of the second inhaler100B during the day thus far, during the past 7 days, during the past 30 days, and so on.

The icons97inFIG.11enable the subject to input a self-assessment, for example a daily self-assessment, relating to how the subject is feeling, particularly in relation to the symptoms of the subject's respiratory disease. In this non-limiting example, the subject selects one of three emoji-type icons according to how they are feeling that day. Box98is a touchpoint which is pressed by the subject to save their daily self-assessment.

The view80C shown inFIG.11may be a home screen99A, but tabs99B,99C, and99D enable other screens to be accessed. Tab99B enables the subject to access a data screen which provides further usage information from the respective inhalers100A,1008,100C. Tab99C enables the subject to access a screen summarizing the inhalers100A,1008,100C connected to the processing module34. Tab80C enables the subject to view their profile, which may contain personal data concerning the subject, such as name, date of birth, and so on.

FIGS.12-15provide a non-limiting example of an inhaler arrangement100which may be included in the system10.

FIG.12provides a front perspective view of an inhaler arrangement100, referred to as “an inhaler” from here on, according to a non-limiting example. The inhaler100may, for example, be a breath-actuated inhaler. The inhaler100may include a top cap102, a main housing104, a mouthpiece106, a mouthpiece cover108, an electronics module120, and an air vent126. The mouthpiece cover108may be hinged to the main housing104so that it may open and close to expose the mouthpiece106. Although illustrated as a hinged connection, the mouthpiece cover106may be connected to the inhaler100through other types of connections. Moreover, while the electronics module120is illustrated as housed within the top cap102at the top of the main housing104, the electronics module120may be integrated and/or housed within the main body104of the inhaler100.

The electronics module120may, for instance, include the above-described use determination system12and the transmission module14. For example, the electronics module120may include a processor, memory configured to perform the functions of use determination system12and/or transmission module14. The electronics module120may include switch(es), sensor(s), slider(s), and/or other instruments or measurement devices configured to determine inhaler usage information as described herein. The electronics module120may include a transceiver and/or other communication chips or circuits configured to perform the transmission functions of transmission module14.

FIG.13provides a cross-sectional interior perspective view of the example inhaler100. Inside the main housing104, the inhalation device100may include a medication reservoir110and a dose metering assembly. For example, the inhaler100may include a medication reservoir110(e.g. a hopper), a bellows112, a bellows spring114, a yoke (not visible), a dosing cup116, a dosing chamber117, a deagglomerator121, and a flow pathway119. The medication reservoir110may include medication, such as dry powder medication, for delivery to the subject. Although illustrated as a combination of the bellows112, the bellows spring114, the yoke, the dosing cup116, the dosing chamber117, and the deagglomerator121, the dose metering assembly may include a subset of the components described and/or the inhalation device100may include a different dose metering assembly (e.g., based on the type of inhalation device, the type of medication, etc.). For instance, in some examples the medication may be included in a blister strip and the dose metering assembly, which may include one or more wheels, levers, and/or actuators, is configured to advance the blister strip, open a new blister that includes a dose of medication, and make that dose of medication available to a dosing chamber and/or mouthpiece for inhalation by the user.

When the mouthpiece cover108is moved from the closed to the open position, the dose metering assembly of the inhaler100may prime a dose of medicament. In the illustrated example ofFIG.13, the mouthpiece cover108being moved from the closed to the open position may cause the bellows112to compress to deliver a dose of medication from the medication reservoir110to the dosing cup116. Thereafter, a subject may inhale through the mouthpiece106in an effort to receive the dose of medication.

The airflow generated from the subject's inhalation may cause the deagglomerator121to aerosolize the dose of medication by breaking down the agglomerates of the medicament in the dose cup116. The deagglomerator121may be configured to aerosolize the medication when the airflow through the flow pathway119meets or exceeds a particular rate, or is within a specific range. When aerosolized, the dose of medication may travel from the dosing cup116, into the dosing chamber117, through the flow pathway119, and out of the mouthpiece106to the subject. If the airflow through the flow pathway119does not meet or exceed a particular rate, or is not within a specific range, the medication may remain in the dosing cup116. In the event that the medication in the dosing cup116has not been aerosolized by the deagglomerator121, another dose of medication may not be delivered from the medication reservoir110when the mouthpiece cover108is subsequently opened. Thus, a single dose of medication may remain in the dosing cup until the dose has been aerosolized by the deagglomerator121. When a dose of medication is delivered, a dose confirmation may be stored in memory at the inhaler100as dose confirmation information.

As the subject inhales through the mouthpiece106, air may enter the air vent to provide a flow of air for delivery of the medication to the subject. The flow pathway119may extend from the dosing chamber117to the end of the mouthpiece106, and include the dosing chamber117and the internal portions of the mouthpiece106. The dosing cup116may reside within or adjacent to the dosing chamber117. Further, the inhaler100may include a dose counter111that is configured to be initially set to a number of total doses of medication within the medication reservoir110and to decrease by one each time the mouthpiece cover108is moved from the closed position to the open position.

The top cap102may be attached to the main housing104. For example, the top cap102may be attached to the main housing104through the use of one or more clips that engage recesses on the main housing104. The top cap102may overlap a portion of the main housing104when connected, for example, such that a substantially pneumatic seal exists between the top cap102and the main housing104.

FIG.14is an exploded perspective view of the example inhaler100with the top cap102removed to expose the electronics module120. As shown inFIG.20, the top surface of the main housing104may include one or more (e.g. two) orifices146. One of the orifices146may be configured to accept a slider140. For example, when the top cap102is attached to the main housing104, the slider140may protrude through the top surface of the main housing104via one of the orifices146.

FIG.15is an exploded perspective view of the top cap102and the electronics module120of the example inhaler100. As shown inFIG.21, the slider140may define an arm142, a stopper144, and a distal end145. The distal end145may be a bottom portion of the slider140. The distal end145of the slider140may be configured to abut the yoke that resides within the main housing104(e.g. when the mouthpiece cover108is in the closed or partially open position). The distal end145may be configured to abut a top surface of the yoke when the yoke is in any radial orientation. For example, the top surface of the yoke may include a plurality of apertures (not shown), and the distal end145of the slider140may be configured to abut the top surface of the yoke, for example, whether or not one of the apertures is in alignment with the slider140.

The top cap102may include a slider guide148that is configured to receive a slider spring146and the slider140. The slider spring146may reside within the slider guide148. The slider spring146may engage an inner surface of the top cap102, and the slider spring146may engage (e.g. abut) an upper portion (e.g. a proximate end) of the slider140. When the slider140is installed within the slider guide148, the slider spring146may be partially compressed between the top of the slider140and the inner surface of the top cap102. For example, the slider spring146may be configured such that the distal end145of the slider140remains in contact with the yoke when the mouthpiece cover108is closed. The distal end145of the slider145may also remain in contact with the yoke while the mouthpiece cover108is being opened or closed. The stopper144of the slider140may engage a stopper of the slider guide148, for example, such that the slider140is retained within the slider guide148through the opening and closing of the mouthpiece cover108, and vice versa. The stopper144and the slider guide148may be configured to limit the vertical (e.g. axial) travel of the slider140. This limit may be less than the vertical travel of the yoke. Thus, as the mouthpiece cover108is moved to a fully open position, the yoke may continue to move in a vertical direction towards the mouthpiece106but the stopper144may stop the vertical travel of the slider140such that the distal end145of the slider140may no longer be in contact with the yoke.

More generally, the yoke may be mechanically connected to the mouthpiece cover108and configured to move to compress the bellows spring114as the mouthpiece cover108is opened from the closed position and then release the compressed bellows spring114when the mouthpiece cover reaches the fully open position, thereby causing the bellows112to deliver the dose from the medication reservoir110to the dosing cup116. The yoke may be in contact with the slider140when the mouthpiece cover108is in the closed position. The slider140may be arranged to be moved by the yoke as the mouthpiece cover108is opened from the closed position and separated from the yoke when the mouthpiece cover108reaches the fully open position. This arrangement may be regarded as a non-limiting example of the previously described dose metering assembly, since opening the mouthpiece cover108causes the metering of the dose of the medicament.

The movement of the slider140during the dose metering may cause the slider140to engage and actuate a switch130. The switch130may trigger the electronics module120to register the dose metering. The slider140and switch130together with the electronics module120may thus be regarded as being included in the use determination system12described above. The slider140may be regarded in this example as the means by which the use determination system12is configured to register the metering of the dose by the dose metering assembly, each metering being thereby indicative of the inhalation performed by the subject using the inhaler100.

Actuation of the switch130by the slider140may also, for example, cause the electronics module120to transition from the first power state to a second power state, and to sense an inhalation by the subject from the mouthpiece106.

The electronics module120may include a printed circuit board (PCB) assembly122, a switch130, a power supply (e.g. a battery126), and/or a battery holder124. The PCB assembly122may include surface mounted components, such as a sensor system128, a wireless communication circuit129, the switch130, and or one or more indicators (not shown), such as one or more light emitting diodes (LEDs). The electronics module120may include a controller (e.g. a processor) and/or memory. The controller and/or memory may be physically distinct components of the PCB122. Alternatively, the controller and memory may be part of another chipset mounted on the PCB122, for example, the wireless communication circuit129may include the controller and/or memory for the electronics module120. The controller of the electronics module120may include a microcontroller, a programmable logic device (PLD), a microprocessor, an application specific integrated circuit (ASIC), a field programmable gate array (FPGA), or any suitable processing device or control circuit.

The controller may access information from, and store data in the memory. The memory may include any type of suitable memory, such as non-removable memory and/or removable memory. The non-removable memory may include random-access memory (RAM), read-only memory (ROM), a hard disk, or any other type of memory storage device. The removable memory may include a subscriber identity module (SIM) card, a memory stick, a secure digital (SD) memory card, and the like. The memory may be internal to the controller. The controller may also access data from, and store data in, memory that is not physically located within the electronics module120, such as on a server or a smart phone.

The sensor system128may include one or more sensors. The sensor system128may be, for example, included in the use determination system12described above. The sensor system128may include one or more sensors, for example, of different types, such as, but not limited to one or more pressure sensors, temperature sensors, humidity sensors, orientation sensors, acoustic sensors, and/or optical sensors. The one or more pressure sensors may include a barometric pressure sensor (e.g. an atmospheric pressure sensor), a differential pressure sensor, an absolute pressure sensor, and/or the like. The sensors may employ microelectromechanical systems (MEMS) and/or nanoelectromechanical systems (NEMS) technology. The sensor system128may be configured to provide an instantaneous reading (e.g. pressure reading) to the controller of the electronics module120and/or aggregated readings (e.g. pressure readings) over time. As illustrated inFIGS.13and14, the sensor system128may reside outside the flow pathway119of the inhaler100, but may be pneumatically coupled to the flow pathway119.

The controller of the electronics module120may receive signals corresponding to measurements from the sensor system128. The controller may calculate or determine one or more airflow metrics using the signals received from the sensor system128. The airflow metrics may be indicative of a profile of airflow through the flow pathway119of the inhaler100. For example, if the sensor system128records a change in pressure of 0.3 kilopascals (kPa), the electronics module120may determine that the change corresponds to an airflow rate of approximately 45 liters per minute (Lpm) through the flow pathway119.

FIG.16shows a graph of airflow rates versus pressure. The airflow rates and profile shown inFIG.16are merely examples and the determined rates may depend on the size, shape, and design of the inhalation device100and its components.

The processing module34may generate personalized data in real-time by comparing signals received from the sensor system128and/or the determined airflow metrics to one or more thresholds or ranges, for example, as part of an assessment of how the inhaler100is being used and/or whether the use is likely to result in the delivery of a full dose of medication. For example, where the determined airflow metric corresponds to an inhalation with an airflow rate below a particular threshold, the processing module34may determine that there has been no inhalation or an insufficient inhalation from the mouthpiece106of the inhaler100. If the determined airflow metric corresponds to an inhalation with an airflow rate above a particular threshold, the electronics module120may determine that there has been an excessive inhalation from the mouthpiece106. If the determined airflow metric corresponds to an inhalation with an airflow rate within a particular range, the electronics module120may determine that the inhalation is “good”, or likely to result in a full dose of medication being delivered.

The pressure measurement readings and/or the computed airflow metrics may be indicative of the quality or strength of inhalation from the inhaler100. For example, when compared to a particular threshold or range of values, the readings and/or metrics may be used to categorize the inhalation as a certain type of event, such as a good inhalation event, a low inhalation event, a no inhalation event, or an excessive inhalation event. The categorization of the inhalation may be usage parameters stored as personalized data of the subject.

The no inhalation event may be associated with pressure measurement readings and/or airflow metrics below a particular threshold, such as an airflow rate less than or equal to 30 Lpm. The no inhalation event may occur when a subject does not inhale from the mouthpiece106after opening the mouthpiece cover108and during the measurement cycle. The no inhalation event may also occur when the subject's inspiratory effort is insufficient to ensure proper delivery of the medication via the flow pathway119, such as when the inspiratory effort generates insufficient airflow to activate the deagglomerator121and, thus, aerosolize the medication in the dosing cup116.

The low inhalation event may be associated with pressure measurement readings and/or airflow metrics within a particular range, such as an airflow rate greater than 30 Lpm and less than or equal to 45 Lpm. The low inhalation event may occur when the subject inhales from the mouthpiece106after opening the mouthpiece cover108and the subject's inspiratory effort causes at least a partial dose of the medication to be delivered via the flow pathway119. That is, the inhalation may be sufficient to activate the deagglomerator121such that at least a portion of the medication is aerosolized from the dosing cup116.

The good inhalation event may be associated with pressure measurement readings and/or airflow metrics above the low inhalation event, such as an airflow rate which is greater than 45 Lpm and less than or equal to 200 Lpm. The good inhalation event may occur when the subject inhales from the mouthpiece106after opening the mouthpiece cover108and the subject's inspiratory effort is sufficient to ensure proper delivery of the medication via the flow pathway119, such as when the inspiratory effort generates sufficient airflow to activate the deagglomerator121and aerosolize a full dose of medication in the dosing cup116.

The excessive inhalation event may be associated with pressure measurement readings and/or airflow metrics above the good inhalation event, such as an airflow rate above 200 Lpm. The excessive inhalation event may occur when the subject's inspiratory effort exceeds the normal operational parameters of the inhaler100. The excessive inhalation event may also occur if the device100is not properly positioned or held during use, even if the subject's inspiratory effort is within a normal range.

For example, the computed airflow rate may exceed 200 Lpm if the air vent is blocked or obstructed (e.g. by a finger or thumb) while the subject is inhaling from the mouthpiece106.

Any suitable thresholds or ranges may be used to categorize a particular event. Some or all of the events may be used. For example, the no inhalation event may be associated with an airflow rate which is less than or equal to 45 Lpm and the good inhalation event may be associated with an airflow rate which is greater than 45 Lpm and less than or equal to 200 Lpm. As such, the low inhalation event may not be used at all in some cases.

The pressure measurement readings and/or the computed airflow metrics may also be indicative of the direction of flow through the flow pathway119of the inhaler100. For example, if the pressure measurement readings reflect a negative change in pressure, the readings may be indicative of air flowing out of the mouthpiece106via the flow pathway119. If the pressure measurement readings reflect a positive change in pressure, the readings may be indicative of air flowing into the mouthpiece106via the flow pathway119. Accordingly, the pressure measurement readings and/or airflow metrics may be used to determine whether a subject is exhaling into the mouthpiece106, which may signal that the subject is not using the device100properly.

The inhaler100may include a spirometer or similarly operating device to enable measurement of lung function metrics. For example, the inhaler100may perform measurements to obtain metrics related to a subject's lung capacity. The spirometer or similarly operating device may measure the volume of air inhaled and/or exhaled by the subject. The spirometer or similarly operating device may use pressure transducers, ultrasound, or a water gauge to detect the changes in the volume of air inhaled and/or exhaled.

The personalized data collected from, or calculated based on, the usage of the inhaler100(e.g. pressure metrics, airflow metrics, lung function metrics, dose confirmation information, etc.) may be computed and/or assessed via external devices as well (e.g. partially or entirely). More specifically, the wireless communication circuit129in the electronics module120may include a transmitter and/or receiver (e.g. a transceiver), as well as additional circuitry. The wireless communication circuit129may include, or define, the transmission module14of the inhaler100.

For example, the wireless communication circuit129may include a Bluetooth chip set (e.g. a Bluetooth Low Energy chip set), a ZigBee chipset, a Thread chipset, etc. As such, the electronics module120may wirelessly provide the personalized data, such as pressure measurements, airflow metrics, lung function metrics, dose confirmation information, and/or other conditions related to usage of the inhaler100, to an external processing module34, such as a processing module34included in a smart phone40. The personalized data may be provided in real time to the external device to enable exacerbation risk prediction based on real-time data from the inhaler100that indicates time of use, how the inhaler100is being used, and personalized data about the subject, such as real-time data related to the subject's lung function and/or medical treatment. The external device may include software for processing the received information and for providing compliance and adherence feedback to the subject via a graphical user interface (GUI). The graphical user interface may be included in, or may define, the user interface38included in the system10.

The airflow metrics may include personalized data that is collected from the inhaler100in real-time, such as one or more of an average flow of an inhalation/exhalation, a peak flow of an inhalation/exhalation (e.g. a maximum inhalation received), a volume of an inhalation/exhalation, a time to peak of an inhalation/exhalation, and/or the duration of an inhalation/exhalation. The airflow metrics may also be indicative of the direction of flow through the flow pathway119. That is, a negative change in pressure may correspond to an inhalation from the mouthpiece106, while a positive change in pressure may correspond to an exhalation into the mouthpiece106. When calculating the airflow metrics, the electronics module120may be configured to eliminate or minimize any distortions caused by environmental conditions. For example, the electronics module120may re-zero to account for changes in atmospheric pressure before or after calculating the airflow metrics. The one or more pressure measurements and/or airflow metrics may be timestamped and stored in the memory of the electronics module120.

In addition to the airflow metrics, the inhaler100, or another computing device, may use the airflow metrics to generate additional personalized data. For example, the controller of the electronics module120of the inhaler100may translate the airflow metrics into other metrics that indicate the subject's lung function and/or lung health that are understood to medical practitioners, such as peak inspiratory flow metrics, peak expiratory flow metrics, and/or forced expiratory volume in 1 second (FEV1), for example. The electronics module120of the inhaler may determine a measure of the subject's lung function and/or lung health using a mathematical model such as a regression model. The mathematical model may identify a correlation between the total volume of an inhalation and FEV1. The mathematical model may identify a correlation between peak inspiratory flow and FEV1. The mathematical model may identify a correlation between the total volume of an inhalation and peak expiratory flow. The mathematical model may identify a correlation between peak inspiratory flow and peak expiratory flow.

The battery126may provide power to the components of the PCB122. The battery126may be any suitable source for powering the electronics module120, such as a coin cell battery, for example. The battery126may be rechargeable or non-rechargeable. The battery126may be housed by the battery holder124. The battery holder124may be secured to the PCB122such that the battery126maintains continuous contact with the PCB122and/or is in electrical connection with the components of the PCB122. The battery126may have a particular battery capacity that may affect the life of the battery126. As will be further discussed below, the distribution of power from the battery126to the one or more components of the PCB122may be managed to ensure the battery126can power the electronics module120over the useful life of the inhaler100and/or the medication contained therein.

In a connected state, the communication circuit and memory may be powered on and the electronics module120may be “paired” with an external device, such as a smart phone. The controller may retrieve data from the memory and wirelessly transmit the data to the external device. The controller may retrieve and transmit the data currently stored in the memory. The controller may also retrieve and transmit a portion of the data currently stored in the memory. For example, the controller may be able to determine which portions have already been transmitted to the external device and then transmit the portion(s) that have not been previously transmitted. Alternatively, the external device may request specific data from the controller, such as any data that has been collected by the electronics module120after a particular time or after the last transmission to the external device. The controller may retrieve the specific data, if any, from the memory and transmit the specific data to the external device.

The data stored in the memory of the electronics module120(e.g. the signals generated by the switch130, the pressure measurement readings taken by the sensory system128and/or the airflow metrics computed by the controller of the PCB122) may be transmitted to an external device, which may process and analyze the data to determine the usage parameters associated with the inhaler100. Further, a mobile application residing on the mobile device may generate feedback for the user based on data received from the electronics module120. For example, the mobile application may generate daily, weekly, or monthly report, provide confirmation of error events or notifications, provide instructive feedback to the subject, and/or the like.

Other variations to the disclosed embodiments can be understood and effected by those skilled in the art in practicing the claimed invention, from a study of the drawings, the disclosure, and the appended claims. In the claims, the word “comprising” does not exclude other elements or steps, and the indefinite article “a” or “an” does not exclude a plurality. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage. Any reference signs in the claims should not be construed as limiting the scope.

Embodiments. Below are non-limiting examples of various embodiments that are discussed herein.

1. A system comprising:

at least one first inhaler configured to deliver a first medicament to a subject, each of the at least one first inhaler comprising:a first use determination system configured to determine a first value of a usage parameter relating to use of the respective first inhaler; anda first transmission module configured to encrypt first data based on the first value, and transmit the encrypted first data;

at least one second inhaler configured to deliver a second medicament to the subject, the second medicament being different from the first medicament, each of the at least one second inhaler comprising:a second use determination system configured to determine a second value of a usage parameter relating to use of the respective second inhaler; anda second transmission module configured to encrypt second data based on the second value, and transmit the encrypted second data;

a user interface; and

a processing module configured to:receive the first encrypted data and the second encrypted data;distinguish between the first encrypted data and the second encrypted data;determine first usage information relating to the first medicament from the distinguished first encrypted data;determine second usage information relating to the second medicament from the distinguished second encrypted data; andcontrol the user interface to communicate the first and second usage information.

2. The system according to claim1, further comprising at least one third inhaler configured to deliver a third medicament to the subject which is different from the first and second medicaments, each of the at least one third inhaler comprising:a third use determination system configured to determine a third value of a usage parameter relating to use of the respective third inhaler; anda third transmission module configured to encrypt third data based on the third value, and transmit the encrypted third data, wherein the processing module is configured to:receive the third encrypted data;distinguish the third encrypted data from the encrypted data transmitted from the respective transmission modules included in the other inhalers included in the system;determine third usage information relating to the third medicament from the distinguished third encrypted data; andcontrol the user interface to communicate the first, second, and third usage information.

3. The system according to claim1or claim2, wherein a first identifier, provided with the first inhaler, is assigned to the first medicament, and a second identifier, provided with the second inhaler, is assigned to the second medicament, wherein the processing module is configured to receive the respective identifiers, and use the respective identifiers to distinguish between the first encrypted data and the second encrypted data.

4. The system according to claim3as according to claim2, wherein a third identifier, provided with the third inhaler, is assigned to the third medicament, wherein the processing module is configured to receive the third identifier, and use the first, second, and third identifiers to distinguish the third encrypted data from the first and second encrypted data.

5. The system according to claim3or claim4, wherein the respective identifier received by the processing module further denotes a dose strength of the respective medicament which the respective inhaler is configured to deliver, and optionally a total number of doses which the respective inhaler contains as supplied to the subject, and wherein the processing module is configured to control the user interface to issue a notification based on the respective usage information and the respective dose strength.

6. The system according to any of claims1to5, wherein the at least one first inhaler comprises two or more first inhalers and/or wherein the at least one second inhaler comprises two or more second inhalers.

7. The system according to any of claims1to6, wherein the usage parameter comprises a use of the respective inhaler; optionally wherein the use determination system comprises a sensor for detecting inhalation of the respective medicament performed by the subject and/or a mechanical switch configured to be actuated prior to, during, or after use of the respective inhaler.

8. The system according to any of claims1to7, wherein the usage parameter comprises a parameter relating to airflow during inhalation of the respective medicament performed by the subject.

9. The system according to claim8, wherein the use determination system comprises a sensor for sensing the parameter; optionally wherein the parameter is at least one of a peak inhalation flow, an inhalation volume, a time to peak inhalation flow, and an inhalation duration.

10. The system according to claim9as according to claim7, wherein the sensor for sensing the parameter is the same as or different from the sensor for detecting inhalation of the respective medicament performed by the subject.

11. The system according to any of claims1to10, wherein a clock module is included in each of the respective inhalers for assigning a time to said usage parameter of the respective inhaler, wherein the processing module is configured to synchronize the clock modules of the respective inhalers; optionally wherein said assigned time is included in the usage information for the respective medicaments.

12. The system according to claim11, wherein the processing module comprises a further clock module, the clock modules of each of the respective inhalers being synchronized according to the time provided by the further clock module; optionally wherein the further clock module is configured to provide the time of the time zone in which the processing module and the respective inhalers are situated.

13. The system according to any of claims1to12, wherein the first medicament is a rescue medicament for use by the subject as needed, and the second medicament is a maintenance medicament.

14. The system according to any of claims1to13, wherein the first medicament is albuterol, and the second medicament is salmeterol combined with fluticasone, budesonide combined with formoterol, or beclomethasone.

15. The system according to any of claims1to14, wherein the user interface is at least partly defined by a first user interface of a user device; optionally wherein the user device is at least one selected from a personal computer, a tablet computer, and a smart phone.

16. The system according to claim15, wherein the processing module is at least partly included in a first processing module included in the user device.

17. A method comprising:receiving first encrypted data from a first transmission module of a first inhaler configured to deliver a first medicament to a subject, the first encrypted data being based on a first value of a usage parameter relating to use of the first inhaler;receiving second encrypted data from a second transmission module included in a second inhaler configured to deliver a second medicament to the subject, the second encrypted data being based on a second value of a usage parameter relating to use of the second inhaler, wherein the second medicament is different from the first medicament;distinguishing between the first encrypted data and the second encrypted data;determining first usage information relating to the first medicament from the distinguished first encrypted data;determining second usage information relating to the second medicament from the distinguished second encrypted data; andcontrolling a user interface to communicate the first and second usage information.

18. The method according to claim17, wherein said receiving the first encrypted data comprises receiving the first encrypted data from each respective first transmission module of a plurality of first inhalers, each of said plurality of first inhalers being configured to deliver the first medicament, and/or wherein said receiving the second encrypted data comprises receiving the second encrypted data from each respective second transmission module of a plurality of second inhalers, each of said plurality of second inhalers being configured to deliver the second medicament.

19. The method according to claim17or claim18, further comprising:

receiving third encrypted data from a third transmission module included in a third inhaler configured to deliver a third medicament which is different from the first and second medicaments;

distinguishing the third encrypted data from the first encrypted data and the second encrypted data;

determining third usage information relating to the third medicament from the distinguished third encrypted data; and

controlling the user interface to communicate the third usage information.

20. The method according to claim19, wherein said receiving the third encrypted data comprises receiving the third encrypted data from each respective third transmission module of a plurality of third inhalers, each of said plurality of third inhalers being configured to deliver the third medicament.

21. The method according to any of claims17to20, comprising:

receiving a first identifier, the first identifier being assigned to the first medicament; and

receiving a second identifier, the second identifier being assigned to the second medicament, wherein the distinguishing between the first encrypted data and the second encrypted data comprises using the first and second identifiers.

22. The method according to claim21as according to claim19or claim20, comprising receiving a third identifier, the third identifier being assigned to the third medicament, wherein the distinguishing the third encrypted data from the first encrypted data and the second encrypted data comprises using the first, second, and third identifiers.

23. The method according to any of claims17to22, wherein a clock module is included in each of the respective inhalers for assigning a time to said usage parameter of the respective inhaler, wherein the method further comprises synchronizing the clock modules of the respective inhalers; optionally wherein said assigned time is included in the usage information for the respective medicaments.

24. The method according to claim23, wherein the synchronizing comprises synchronizing each of the respective clock modules with the time of the time zone in which the respective inhalers are situated.

25. A computer program comprising computer program code which is adapted, when said computer program is run on a computer, to implement the method of any of claims17to24.