Drug delivery device having electronics and power management - Patents.com

Abstract

The system may reduce battery usage of the inhalation device by limiting the number of times the inhalation device transmits inhalation data to one. The system may include an inhalation device having a medication and an electronic module. The system may limit the number of times the inhalation device transmits new inhalation data to any mobile device to one by having a server receive new inhalation data from one of the mobile devices and having the server transmit the new inhalation data to the other mobile device before the other mobile device transmits a request for new inhalation data to the inhalation device. The inhalation device may include a quick response (QR) code, and the mobile application may determine at least one of the medication type or dose number of the inhalation device from the QR code.

Description

[Technical field]

[0001] [CROSS REFERENCE TO RELATED APPLICATIONS] This application claims the benefit of Provisional U.S. Patent Application No. 62 / 870,894, filed July 5, 2019, the disclosure of which is incorporated herein by reference in its entirety. [Background technology]

[0002] Drug delivery devices facilitate the delivery of drugs into the patient's body via various routes of administration. Typical routes of administration include oral, topical, sublingual inhalation, injection, etc. The devices can be used to deliver drugs for the treatment of various diseases, illnesses, and medical conditions. For example, inhalation devices can be used to treat asthma, chronic obstructive pulmonary disease (COPD), and cystic fibrosis (CF). Although drug delivery devices can be designed to deliver an appropriate dose of drug to a patient as part of a therapeutic treatment, the effectiveness of the treatment can be affected by non-physiological factors such as the patient's adherence and compliance in using the device.

[0003] A drug delivery device may be equipped with sensors to track adherence and compliance. For example, the device may include sensors to detect when the device is activated to deliver a dose of medication and / or its orientation during activation. This information may be stored in a local memory and then communicated to another device, such as a smartphone, tablet, or computer, for further processing. The device's activation history may be compared to a dosing regimen prescribed by a physician to determine the patient's level of adherence. Other sensor data, such as the device's orientation during activation, may be considered to determine whether the patient is using the device in a compliant manner that facilitates proper delivery of medication.

[0004] To support the addition of sensors and communication mechanisms, the drug delivery device may include a local power source. If the drug delivery device is portable, the local power source may also be portable. For example, the local power source may be a small battery. Certain factors such as size, weight, and / or cost may limit the type of viable power source for the device. Thus, when selecting a power source for a drug delivery device having electrical components, a finite amount of power will be available. DISCLOSURE OF THEINVENTION

[0005] [overview] The system may be configured to limit the number of times an inhalation device (e.g., an inhaler) transmits inhalation data to a single instance, to help, for example, reduce battery usage of the inhalation device. The system may include one or more inhalation devices. The inhalation device may include a mouthpiece, a medication, and an electronic module. The medication may include albuterol (such as, for example, albuterol sulfate at a concentration of 117 mcg), fluticasone (such as, for example, fluticasone propionate, such as, for example, 55 mcg, 113 mcg, or 232 mcg of fluticasone propionate per dose delivered by an inhalation device), beclomethasone dipropionate, or a combination of fluticasone (such as, for example, fluticasone propionate, such as, for example, 55 mcg, 113 mcg, or 232 mcg of fluticasone propionate per dose delivered by an inhalation device) and salmeterol (such as, for example, salmeterol xinafoate, such as 14 mcg of salmeterol xinafoate per dose delivered by an inhalation device). The electronic module may include any combination of a controller (e.g., a processor), communications circuitry (e.g., a transmitter, receiver, transceiver, etc.), one or more sensors (e.g., pressure sensors, temperature sensors, humidity sensors, orientation sensors, etc.), a power source, and / or memory. The system may also include a cloud-based system (e.g., a remote server such as a database) that includes a connection (e.g., a wired connection) to a public or private network to facilitate communication between the cloud-based system and one or more external devices (e.g., a computer, a tablet, a mobile device, etc.).

[0006] The system may also include multiple mobile devices, each of which may include communication circuitry, memory, and a mobile application for an inhalation device (e.g., a mobile application specific to the inhalation device, etc.). The mobile devices (e.g., and their respective mobile applications) may be controlled, for example, by different family members or healthcare providers, for example, to ensure that a user of the inhalation device is adherent to and compliant with the user's medication schedule.

[0007] In some examples, a first mobile application residing on the first mobile device may be configured to cause the first mobile device to send a request for inhalation data to the inhalation device, receive inhalation data from the inhalation device (e.g., which may include a timestamp or a counter value determined by the inhalation device), and send the inhalation data to the cloud-based system. In some examples, the request for inhalation data may include an indication of the latest inhalation data of the inhalation device stored on the first mobile device. Thus, the inhalation data received by the first mobile application from the inhalation device in response to the request may come after (be later in time) the indication (e.g., request) sent to the inhalation device. For example, the inhalation data may occur after (be subsequent to) any inhalation data that may already be stored on the first mobile device. For example, the indication may include a timestamp of the latest inhalation data of the inhalation device stored on the first mobile device, and the inhalation data sent in response to the request may be inhalation data that is later in time than the timestamp of the latest inhalation data (e.g., only the inhalation data that is later in time than the timestamp).

[0008] A second mobile application residing on a different mobile device may be configured to cause the second mobile device to send a request to the cloud-based system and to receive inhalation data of the inhalation device from the cloud-based system in response to the request. The second mobile application may be configured to cause the second mobile device to send a request to the cloud-based system before the second mobile device sends a request for inhalation data to the inhalation device, thereby ensuring that battery usage of the inhalation device is reduced. In some examples, the request may include an indication of a last synchronization time between the second mobile application and the inhaler. Thus, the cloud-based system may be configured to send inhalation data that is after the last synchronization time between the second mobile application and the inhaler. In some examples, the second mobile application is configured to cause the second mobile device to send a request to the cloud-based system in response to detecting a user login event to the second mobile application before the second mobile device sends a request for inhalation data to the inhalation device.

[0009] In some embodiments, the first and second mobile applications may be authenticated by (e.g., associated with) the inhalation device by the cloud-based system prior to receiving inhalation data from the inhalation device and / or prior to transmitting inhalation data to or receiving inhalation data from the cloud-based system. For example, the second mobile application may be configured to cause the second mobile device to transmit a product identifier (ID) associated with the inhalation device or a patient ID associated with the patient of the inhalation device to the cloud-based system prior to the second mobile application receiving inhalation data of the inhalation device from the cloud-based system. The mobile application may receive the product ID via a Quick Response Code (QR Code) provided on the inhalation device.

[0010] For example, the system may include an inhalation device and one or more mobile applications. The system may be configured to authenticate the mobile application (e.g., associate the mobile application / mobile device with the inhalation device) and to verify that the inhalation device is properly marked (e.g., verify that the marked medication on the inhalation device is correct). The inhalation device may include a medication, an electronic module, and a QR code. The mobile application may reside on a mobile device equipped with a camera. The mobile application may be configured to use the QR code to determine information about the inhalation device (e.g., medication type and / or number of doses administered on the inhalation device). For example, the mobile application may be configured to access the camera to receive information about the QR code, determine a product identifier (ID) of the inhalation device based on the QR code, and determine information about at least one of the medication type or number of doses administered on the inhalation device based on the product ID. For example, the product ID may be a multi-character code that directly indicates the type of medication, the strength of the medication, and / or the number of doses administered in the inhalation device. Alternatively or additionally, the mobile application may transmit the product ID to a cloud-based system, and the cloud-based system may transmit information about the inhalation device to the mobile application.

[0011] The mobile application may also be configured to determine a dosing schedule and / or one or more dosing reminders based on the QR code. For example, the mobile application may be configured to determine the dosing schedule of the inhalation device and / or the timing of dosing reminders directly from the QR code (e.g., via the product ID). Alternatively or additionally, the mobile application may receive the dosing schedule and / or the timing of dosing reminders from a cloud-based system using the product ID. The mobile application may be configured to provide one or more dosing reminders based on the dosing schedule.

[0012] In examples where the inhalation device includes a QR code, the inhalation device does not include an actuator, button, or switch to initiate a communication pairing process with the mobile device. Rather, the mobile application may be configured to pair the mobile device (e.g., the mobile device's communication module) to the inhalation device (e.g., the inhalation device's communication module) using the QR code. For example, the mobile application may be configured to determine a communication passkey unique to the inhalation device based on the QR code and cause the mobile device to transmit the communication passkey to the inhalation device's electronic module to enable communication between the electronic module and the mobile application. The communication passkey may include a product ID. The communication passkey may include, for example, a Bluetooth Low Energy (BLE) passkey.

[0013] The mobile application may be configured to determine that the inhalation device is incompatible with the mobile application based on the medication type of the inhalation device and display an error message based on the inhalation device being incompatible with the mobile application. Further, the mobile application may be configured to reject the pairing process between the inhalation device and the mobile device based on the inhalation device being incompatible with the mobile application. [Brief description of the drawings]

[0014] FIG. 1 is a front perspective view of an exemplary inhalation device.

[0015] FIG. 2 is a cross-sectional internal perspective view of an exemplary inhalation device.

[0016] FIG. 3 is an exploded perspective view of the inhalation device with the top cap removed to expose the electronic module.

[0017] FIG. 4 is an exploded perspective view of the top cap and electronic module of the inhalation device.

[0018] FIG. 5 is a diagram of an exemplary system including an inhalation device.

[0019] FIG. 6 is an example airflow versus pressure graph.

[0020] [Detailed Description] This disclosure describes devices, systems, and methods for sensing, tracking, and / or processing usage conditions and parameters associated with a drug delivery device. The devices, systems, and methods are described in the context of a breath-actuated inhalation device for delivering medication to a user's lungs. However, the described solutions are equally applicable to other drug delivery devices, such as syringes, metered-dose inhalers, nebulizers, transdermal patches, or implantables.

[0021] Asthma and COPD are chronic inflammatory diseases of the airways. Both are characterized by variable and recurrent symptoms of airflow obstruction and bronchospasm. Symptoms include wheezing, coughing, chest tightness, and shortness of breath. Symptoms are managed by avoiding triggers and by the use of medications, especially inhaled medications. Medications include inhaled corticosteroids (ICS) and bronchodilators.

[0022] Inhaled corticosteroids (ICS) are steroid hormones used for long-term control of respiratory diseases. They work by reducing inflammation in the airways. Examples include budesonide, beclomethasone (HFA dipropionate / dipropionate), fluticasone (propionate), mometasone (furoate), ciclesonide, and dexamethasone (sodium). Parentheses indicate the formation of salts or esters of the examples (e.g., preferred examples).

[0023] 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 on β2-adrenergic receptors inducing smooth muscle relaxation, dilating the bronchial passages. They tend to be classified by their duration of action. Examples of long-acting β2-agonists (LABAs) include formoterol (fumaric acid), salmeterol (xinafoic acid), indacaterol (maleic acid), bambuterol (hydrochloride), clenbuterol (hydrochloride), olodaterol (hydrochloride), carmoterol (hydrochloride), tulobuterol (hydrochloride) and vilanterol (triphenylacetate). Examples of short-acting beta2-agonists (SABAs) include albuterol (sulfate) and terbutaline (sulfate).

[0024] Typically, short-acting bronchodilators provide rapid relief from acute bronchoconstriction (and are often referred to as "rescue" or "reliever" drugs), while long-acting bronchodilators help control and prevent symptoms for longer periods of time. However, fast-acting long-acting bronchodilators may be used as rescue drugs, such as formoterol (fumarate). Thus, rescue drugs provide relief from acute bronchoconstriction. Rescue drugs are taken pro re nata. Rescue drugs may also be in the form of combination products, such as ICS-formoterol (fumarate), typically budesonide-formoterol (fumarate) or beclomethasone (dipropionate)-formoterol (fumarate). Thus, rescue drugs are preferably SABAs or fast-acting LABAs, more preferably albuterol (sulfate) or formoterol (fumarate), most preferably albuterol (sulfate).

[0025] Anticholinergics (or "antimuscarinic agents") selectively block the neurotransmitter acetylcholine by blocking the receptors of nerve cells. In topical application, anticholinergics act primarily on the M3 muscarinic receptors present in the airways, resulting in smooth muscle relaxation and thus bronchodilatory effects. Examples of long-acting muscarinic antagonists (LAMAs) include tiotropium (bromide), oxitropium (bromide), aclidinium (bromide), umeclidinium (bromide), ipratropium (bromide), glycopyrronium (bromide), oxybutynin (hydrochloric acid or hydrobromide), tolterodine (tartrate), trospium (chloride), solifenacin (succinic acid), fesoterodine (fumaric acid), and darifenacin (hydrobromide).

[0026] Many approaches have been taken in preparing and formulating these medications for delivery by inhalation, such as via dry powder inhalers (DPIs), pressurized metered dose inhalers (pMDIs) or nebulizers.

[0027] According to the GINA (Global Initiative for Asthma) guidelines, a stepwise approach can be taken to treat asthma. In step 1, representing mild asthma, the patient is given a SABA, such as albuterol sulfate, as needed. The patient may also be given low-dose ICS-formoterol as needed, or low-dose ICS whenever a SABA is taken. In step 2, regular low-dose ICS is given in parallel with the SABA, or low-dose ICS-formoterol is given as needed. In step 3, a LABA is added. In step 4, the dose is increased, and in step 5, further add-on treatments, such as anticholinergics or low-dose oral corticosteroids, are included. Each step can therefore be considered a treatment regimen, and each of the regimens may be configured according to the degree of acute severity of the respiratory disease.

[0028] COPD is the leading cause of death worldwide. It is a heterogeneous long-term disease that includes chronic bronchitis, emphysema, and also involves the small airways. The pathological changes that occur in patients with COPD are predominantly localized in the airways, lung parenchyma, and pulmonary vasculature. Phenotypically, these changes reduce the healthy ability of the lungs to absorb and release gas.

[0029] Bronchitis is characterized by long-term inflammation of the bronchi. Common symptoms include wheezing, shortness of breath, coughing and expectoration of sputum, all of which are very uncomfortable and detrimental to the patient's quality of life. Emphysema is also associated with long-term bronchial inflammation, the inflammatory response of which leads to the breakdown of lung tissue and progressive narrowing of the airways. Over time, the lung tissue loses its natural elasticity and expands. In this way, the efficiency with which gases are exchanged decreases and respiratory air is often trapped within the lungs. This results in localized hypoxia, decreasing the volume of oxygen being delivered into the patient's bloodstream with each inhalation. Thus, the patient experiences shortness of breath and difficulty in breathing.

[0030] Patients living with COPD will routinely experience some, if not all, of these symptoms. Their severity will depend on a range of factors, but will most commonly correlate with disease progression. Regardless of their severity, these symptoms indicate stable COPD, a condition that is maintained and managed through the administration of a variety of medications. Treatments vary but often include inhaled bronchodilators, anticholinergics, long- and short-acting beta2-agonists, and corticosteroids. Medications are often administered as monotherapy or in combination therapy.

[0031] Patients are classified according to the severity of their COPD using categories defined by the GOLD guidelines (Global Initiative for Chronic Obstructive Lung Disease, Inc.). The categories are labeled A-D, and the recommended first choice of treatment varies by category. Patient group A is recommended a short-acting muscarinic antagonist (SAMA) or a short-acting beta2-agonist (SABA) as needed. Patient group B is recommended a long-acting muscarinic antagonist (LAMA) or a long-acting beta2-agonist (LABA). Patient group C is recommended an inhaled corticosteroid (ICS) + LABA or a LAMA. Patient group D is recommended an ICS + LABA and / or a LAMA.

[0032] Patients suffering from respiratory diseases such as asthma or COPD suffer from periodic exacerbations beyond the baseline day-to-day fluctuations of their condition. An exacerbation is an acute worsening of respiratory symptoms that requires additional treatment, i.e. beyond maintenance therapy.

[0033] In asthma, add-on treatments for moderate exacerbations are repeated administration of SABAs, oral corticosteroids and / or controlled-flow oxygen (the latter requiring hospitalization). Severe exacerbations involve the addition of anticholinergics (typically ipratropium bromide), nebulized SABAs or IV magnesium sulfate.

[0034] In the case of COPD, add-on treatments for moderate exacerbations are repeated administration of SABAs, oral corticosteroids, and / or antibiotics. Severe exacerbations add controlled flow oxygen and / or respiratory support (both of which require hospitalization). An exacerbation within the meaning of this disclosure includes both moderate and severe exacerbations.

[0035] 1 is a front perspective view of an exemplary inhalation device 100. The exemplary inhalation device 100 may be a breath-actuated inhalation device. The inhalation device 100 may include a top cap 102, a main housing 104, a mouthpiece 106, a mouthpiece cover 108, a medication, and a vent 125. The top cap 102 may be mechanically attached to the main housing 104. The mouthpiece cover 108 may be hinged to the main housing 104 such that it can be opened and closed to expose the mouthpiece 106. Although a hinged connection is illustrated, the mouthpiece cover 108 may be connected to the inhalation device 100 via other types of connections.

[0036] The inhalation device 100 may include a rescue or maintenance medication. The rescue medication may be a SABA or a fast-acting LABA, such as formoterol (fumarate). The rescue medication may also be in the form of a combination product, such as ICS-formoterol (fumarate), typically budesonide formoterol (fumarate) or beclomethasone (dipropionate)-formoterol (fumarate). Such an approach is called "MART" (maintenance and rescue therapy). In some examples, the medication is albuterol (sulfate), fluticasone (propionate or furoate), or salmeterol (xinafoate) in combination with fluticasone (propionate or furoate).

[0037] 2 is a cross-sectional internal perspective view of the inhalation device 100. Inside the main housing 104, the inhalation device 100 may include a drug reservoir and a dose delivery mechanism / system. For example, the inhalation device may include a drug reservoir 110 (e.g., a hopper), a bellows 112, a bellows spring 114, a yoke 118, a dose counter 111, a transparent window 147, a dose cup 116, a dose chamber 117, a deagglomerator 121, and a flow path 119. The drug reservoir 110 may contain a drug, such as a dry powder vehicle, which may be delivered to a user via the mouthpiece 106. The yoke 118 may be mechanically coupled (e.g., directly or indirectly) to the mouthpiece cover 108 such that movement of the mouthpiece cover 108 results in movement of the yoke 118. For example, when the mouthpiece cover 108 is moved (e.g., from a closed position to an open position) to expose the mouthpiece 106, the yoke 118 may move up and down within the inhalation device 100 (e.g., toward or away from the top cap 102).

[0038] Movement of the yoke 118 may compress the bellows 112, thereby delivering a dose of the drug from the drug reservoir 110 to the dosing cup 116. The user may then inhale through the mouthpiece 106 to receive the dose of the drug. The airflow resulting from the user's inhalation causes the deagglomerator 121 to aerosolize the dose of the drug by breaking up agglomerates of the drug in the dosing cup 116. The deagglomerator 121 may be configured to aerosolize the drug (e.g., completely) when the airflow through the flow passage 119 meets or exceeds a certain flow rate, or is within a particular range. Once aerosolized, the dose of the drug may travel from the dosing cup 116 into the dosing chamber 117, through the flow passage 119, and out of the mouthpiece 106 to the user. If the airflow through the flow passage 119 does not meet or exceed a certain velocity or is not within a certain range, all or a portion of the medicament may remain in the dose cup 116. If the medicament in the dose cup 116 is not aerosolized by the disaggregator 121, another dose of medicament may not be delivered from the medicament reservoir 110 when the mouthpiece cover 108 is subsequently opened. Thus, at least a portion of the dose of medicament may accumulate in the dose cup 116 until the dose is aerosolized by the disaggregator 121.

[0039] When a user inhales through the mouthpiece 106, air may enter the vent 125 and provide an air flow for delivery of medication to the user. The flow passage 119 may extend from the dosing chamber 117 to the end of the mouthpiece 106. The flow passage may include the dosing chamber 117 and an interior portion of the mouthpiece 106. The dosing cup 116 may be within or adjacent to the dosing chamber 117.

[0040] Although a combination of bellows 112, bellows spring 114, yoke 118, dosing cup 116, dosing chamber 117, and deagglomerator 121 is illustrated, the dose delivery mechanism may include a subset of the described components and / or the inhalation device 100 may include a different dose delivery mechanism (e.g., depending on the type of inhalation device, the type of medicament, etc.). For example, in some examples, the medicament may be contained in a blister strip and the dose delivery mechanism (e.g., one or more wheels, levers, and / or actuators) may be configured to advance the blister strip, open a new blister containing a dose of the medicament, and make the dose of the medicament available at the dosing chamber and / or mouthpiece for inhalation by the user.

[0041] In the exemplary dose delivery mechanism of FIG. 1 , the dose counter 111 may be mechanically coupled (e.g., directly or indirectly) to the mouthpiece cover 108 such that the dose counter 111 increments or decrements when the mouthpiece cover 108 is opened or closed. The dose counter 111 may be initially set to the total number of doses available, which may be the number of doses in the drug reservoir 110 or the number of doses notified by the manufacturer. Thus, the dose counter 111 may be configured to decrement by one each time the mouthpiece cover 108 is moved from the open position to the closed position (or from the closed position to the open position), thereby indicating the remaining number of doses available. Alternatively, the dose counter 111 may be initially set to zero and configured to increment by one each time the mouthpiece cover 108 is moved from the open position to the closed position (or from the closed position to the open position), thereby indicating the total number of doses delivered from the drug reservoir 110.

[0042] The inhalation device 100 may include an electronic module 120, which may be housed in the top cap 102. The electronic module 120 may include a printed circuit board (PCB) assembly 122 having one or more electrical components, such as a sensor system 128 and a wireless communication circuit 129. The sensor system 128 may be configured to detect one or more parameters related to the use of the device and / or the environment in which the device is used or stored. The wireless communication circuit 129 may be configured to transmit the detected parameters to an external device, such as a smartphone, tablet, or computer, for further processing.

[0043] 3 is an exploded perspective view of an exemplary inhalation device 100 with the top cap 102 removed to expose the electronic module 120. The top cap 102 may house the electronic module 120, which may include a printed circuit board (PCB) assembly 122. The PCB assembly 122 may include one or more components, such as a sensor system 128 and a wireless communication circuit 129. The top cap 102 may be attached to the main housing 104 via one or more clips (not shown) that engage recesses on the main housing 104. The top cap 102 may overlap a portion of the main housing 104 when connected, for example, such that a substantial pneumatic seal exists between the top cap 102 and the main housing 104. The top surface of the main housing 104 may include one or more (e.g., two) orifices 146. One of the orifices 146 may be configured to receive the slider 140. For example, when the top cap 102 is attached to the main housing 104, the slider 140 may protrude through a top surface of the main housing 104 through one of the orifices 146. The top cap 102 may be removably attached to the main housing 104. Alternatively or additionally, the electronic module 120 may be integrated within the main housing 104 and / or the top cap 102 housing the electronic module 120 may be non-removably attached to the main housing 104.

[0044] Furthermore, in some examples, the electronic module 120 may be a separate device external to and separate from the inhalation device 100. For example, the electronic module 120 may be present in an add-on device that is configured to be attached to the inhalation device 100 and then removed from the inhalation device 100, for example, when the inhalation device 100 runs out of medication or the medication has expired. In such a case, a user may attach the add-on device including the electronic module 120 from one inhalation device 100 to another inhalation device 100 each time the user receives a new inhalation device 100. The add-on device may be configured to be attached to any component of the inhalation device 100, such as the main housing 104, the mouthpiece, and / or the medication canister housed in the main housing 104 of the inhalation device 100 (e.g., such that the sensor is in fluid communication with the mouthpiece and / or the flow path of the inhalation device 100). Thus, in some examples, the inhalation device 100 may be replaced by an add-on device that includes the electronic module 120 (eg, in whole or in part), or even an inhaler that does not include electronics.

[0045] 4 is an exploded perspective view of the top cap 102 and the electronic module 120. As shown in FIG. 4, the slider 140 may define an arm 142, a stopper 144, and an end base 145. The end 145 may be a bottom of the slider 140. The end 145 of the slider 140 may be configured to abut a yoke 118 within the main housing 104. The top cap 102 may include a slider spring 146 and a slider guide 148 configured to receive the slider 140. The slider spring 146 may reside within the slider guide 148. The slider spring 146 may engage an inner surface of the top cap 102, and the slider spring 146 may engage (e.g., abut) an upper portion (e.g., a proximal end) of the slider 140. When the slider 140 is disposed within the slider guide 148, the slider spring 146 may be partially compressed between the top of the slider 140 and the inner surface of the top cap 102. For example, the slider spring 146 may be configured such that the end 145 of the slider 140 remains in contact with the yoke 118 when the mouthpiece cover 108 is closed.

[0046] The end 145 of the slider 145 may also remain in contact with the yoke 118 while the mouthpiece cover 108 is opened or closed. The stopper 144 of the slider 140 may, for example, engage with a stopper of the slider guide 148 such that the slider 140 is retained within the slider guide 148 through opening and closing of the mouthpiece cover 108, or vice versa. The stopper 144 and the slider guide 148 may be configured to limit the up and down (e.g., axial) movement of the slider 140. This limit may be less than the up and down movement of the yoke 118. Thus, when the mouthpiece cover 108 is moved to the open position, the yoke 118 may continue to move in an up and down direction toward the mouthpiece 106, but the stopper 144 may stop the up and down movement of the slider 140 such that the end 145 of the slider 140 no longer contacts the yoke 118.

[0047] As described above, the electronic module 120 may include one or more components, such as the sensor system 128 and the wireless communication circuitry 129. The electronic module 120 may further include a switch 130, a power source 126 (e.g., a battery), a power source holder 124, an indicator (e.g., a light emitting diode (LED)), a controller (e.g., a processor), and / or a memory. As used herein, the terms "controller" and "processor" may be used interchangeably. One or more of the components of the electronic module 120 may be mounted on and electrically connected to the PCB 122. The controller and / or memory may be physically separate components from the PCB 122. Alternatively, the controller and memory may be part of a chipset mounted on the PCB 122. For example, the wireless communication circuitry 129 may include the controller and / or memory for the electronic module 120. The controller of electronic module 120 may 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 circuitry. The memory may include computer-executable instructions that, when executed by the controller, cause the controller to perform the processes of the electronic module described herein.

[0048] The controller may access information from the memory and store data in the memory. The memory may include any type of suitable memory, such as non-removable and / or removable memory. The non-removable memory may include a random access memory (RAM), a 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, or 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 electronic module 120, such as on a server or a smartphone.

[0049] The battery 126 may provide power to the components of the PCB 122. The battery 126 may be any suitable power source for providing power to the electronic module 120, such as, for example, a coin cell battery. The battery 126 may be rechargeable or non-rechargeable. The battery 126 may be housed by a battery holder 124. The battery holder 124 may be secured to the PCB 122 so that the battery 126 remains in continuous contact with the PCB 122 and / or is in electrical communication with the components of the PCB 122. The battery 126 may have a battery capacity that may affect the lifespan of the battery 126. As will be further described below, the distribution of power from the battery 126 to one or more components of the PCB 122 may be managed to ensure that the battery 126 can provide power to the electronic module 120 for the useful lifespan of the inhalation device 100 and / or the medicament contained therein.

[0050] The switch 130 may be actuated by the dose delivery mechanism of the inhalation device 100. When incorporated with the exemplary dose delivery mechanism described herein, the switch 130 may be actuated by the slider 140 when the mouthpiece cover 108 is moved from a closed position to an open position. It should be understood that if the inhalation device 100 includes a different dose delivery mechanism, the switch 130 may be actuated by a different component of the dose delivery mechanism. When the switch 130 is actuated, the electronic module 120 may generate a signal that causes the electronic module 120 to change state, such as from an off or sleep state to an active state. When in the active state, the controller of the electronic module 120 may wake up and power the sensor system 128 so that the sensor system 128 can take measurements. Additionally, the electronic module 120 may store a dosing event (which may be referred to as, for example, a dose delivery event or an actuation event) each time the switch 130 is actuated. As described in more detail below, electronic module 120 may have multiple power states, each having a respective power consumption level. For example, electronic module 120 may be configured to operate in a system off state, a sleep state, and / or an active state, where electronic module 120 consumes a minimal amount of power during the off state (e.g., no power or just enough to run a clock), the sleep state uses more power than the off state (e.g., to power memory, communication circuitry, and / or timers or clocks), and the active state uses a maximum amount of power (e.g., to power a controller, one or more sensors, and / or run timers or clocks, potentially in a faster notification mode than the sleep state).

[0051] The sensor system 128 may include one or more sensors, such as one or more pressure sensors, temperature sensors, humidity sensors, orientation sensors, acoustic sensors, and / or optical sensors. The pressure sensors may include air pressure sensors (e.g., atmospheric pressure sensors), differential pressure sensors, absolute pressure sensors, and / or the like. The sensors may employ Microelectromechanical Systems (MEMS) and / or Nanoelectromechanical Systems (NEMS) technology. The pressure sensors may be configured to detect and / or measure pressure changes in the inhalation device 100 caused by inhalation through (or exhalation into) the mouthpiece 106. One or more of the measured pressure changes may be used to determine an amount of airflow (e.g., airflow rate) through the flow passage 119 of the mouthpiece 106. The magnitude of the airflow may indicate whether the user is using the device 100 properly. For example, if the deagglomerator 121 is configured to aerosolize a dose of medication when the airflow rate exceeds a threshold, use may be considered compliant if the determined airflow rate exceeds the threshold, and conversely, use may be considered non-compliant if the determined airflow rate is below the threshold.

[0052] The electronic module 120 (e.g., and / or a mobile application residing on an external device) may use measurements from the sensor system 128 to determine one or more administration events. For example, the electronic module 120 may be configured to compare one or more measurements from the sensor system 128 to one or more thresholds to classify an inhalation event as a no inhalation / low inhalation event, a reasonable inhalation event, a good inhalation event, an excessive inhalation event, and / or an exhalation event. For example, the electronic module may generate a good inhalation event if measurements from the sensor system 128 indicate a flow rate in a particular range (e.g., between 200 liters per minute (L / min) and 45 L / min), generate a valid inhalation event if measurements from the sensor system 128 indicate a flow rate in another range (e.g., between 30 L / min and 45 L / min), generate a no inhalation event if measurements from the sensor system 128 indicate a flow rate below a threshold (e.g., 30 L / min), and generate an excessive inhalation event if measurements from the sensor system 128 indicate a flow rate above an upper threshold (e.g., above 200 L / min).

[0053] The temperature sensor may include a thermistor, a thermocouple, a resistance temperature detector, a temperature sensor chip, etc. The temperature sensor may be configured to provide a temperature value and / or a temperature value aggregated over time to a controller of the electronics module 120. The temperature sensor may be configured to measure an external temperature in a space proximate to the inhalation device 100. Thus, the main housing 104 and / or the top cap 102 may include an opening (e.g., a vent) that allows the temperature sensor to measure the ambient temperature outside the housing.

[0054] Alternatively or additionally, the temperature sensor(s) may be configured to measure a temperature within the inhalation device 100, such as within one or more of the top cap 102, the main housing 104, and / or the mouthpiece 106 of the inhalation device 100. The ability to measure both internal and external temperatures may enable the electronic module 120 to determine the operating temperatures of components of the electronic module 120, the temperature of air flowing through the inhalation device 100 as a user inhales through the inhalation device 100, etc. Thus, the electronic module 120 may be configured to detect over- or under-temperature conditions, such as an over-temperature condition of one or more components of the electronic module 120 (e.g., another sensor, such as a pressure sensor), an over-temperature condition of the inhalation device 100, an ambient temperature above a threshold, etc. The electronic module 120 may be configured to cause the communication circuitry 129 to transmit a temperature message to an external device (e.g., a mobile device) indicating an over-temperature condition, an ambient temperature value, and / or an internal temperature value of the inhalation device 100 (e.g., a temperature change detected through a flow path of the inhalation device 100).

[0055] Further, in some examples, the pressure sensor may include a temperature sensor. The humidity sensor may include a capacitance sensor, a resistance sensor, a thermal conductivity sensor, and / or the like. The humidity sensor may be configured to provide a humidity value and / or a humidity value aggregated over time to a controller of the electronic module 120. The temperature and / or humidity measurements may be used to identify and track environmental conditions in which the inhalation device 100 is used or stored. The temperature and / or humidity measurements may be used to determine whether the device 100 is operating or stored in an environment that may impair the proper orientation of the device 100 and / or the effectiveness of the drug in the drug reservoir 110. For example, extremely high or low temperatures or excessive humidity levels may contribute to device failure and / or change the properties of the drug in the reservoir 110.

[0056] The orientation sensor may include an accelerometer, a gravity (G) sensor, a gyroscope, a magnetometer, etc. The orientation sensor may be configured to provide the controller of the electronic module 120 with an orientation value (e.g., acceleration, rotation, direction, etc.) and / or an orientation value aggregated over time. Data from the orientation sensor may be used to identify and track how a user is handling or interacting with the device 100 as they attempt to receive a dose of medication. The data may be used to determine whether the device 100 is being operated in a compliant manner, such as during dose delivery. For example, the orientation sensor may indicate if a user is holding the device 100 upside down during inhalation, which may prevent or impede delivery of a full dose of medication from the dosing cup 116 and / or dosing chamber 117.

[0057] As mentioned above, the electronic module 120 may include one or more indicators, such as LEDs, that may be housed in or located on the device 100 such that any provided feedback may be observed by the user. A controller in the electronic module 120 may activate the indicators to provide feedback to the user regarding the use of the inhalation device 100 and / or the circumstances under which the inhalation device 100 is being used or stored. The controller may change the state of the indicator (e.g., the LED may light up, flash, change color, etc.) if one or more measurements from the sensor system 128 exceed or fall below a predetermined threshold. For example, the controller may light up an LED if a measured pressure change, a determined airflow rate, a measured temperature, and / or a measured humidity level exceed a threshold. The controller may light up an LED if data from the orientation sensor indicates that the device 100 is not being held properly.

[0058] Data from the sensor system 128 (e.g., pressure changes, temperature, humidity levels, etc.) and / or parameters derived therefrom (e.g., airflow rate) may be communicated to an external device, such as a smartphone, tablet, or computer. More specifically, the wireless communication circuitry 129 in the electronic module 120 may include a transmitter and / or a receiver (e.g., a transceiver) and additional circuitry. For example, the wireless communication circuitry 129 may include a Bluetooth chipset (e.g., a Bluetooth Low Energy chipset), a ZigBee chipset, a Thread chipset, etc. Thus, the electronic module 120 may wirelessly provide data to an external device for review and / or further processing. The external device may include software for processing the received information and for providing compliance and adherence feedback to the user of the inhalation device 100 via a graphical user interface (GUI).

[0059] The power source 126 may provide power to the electrical components of the PCB 122. The power source 126 may be any suitable source for providing power to the electronics module 120, such as, for example, a coin cell battery. The power source 126 may be rechargeable or non-rechargeable. The power source 126 may be housed by a power source holder 124. The power source holder 124 may be secured to the PCB 122 such that the power source 126 maintains continuous contact with the PCB 122 and / or electrically couples with the components of the PCB 122.

[0060] The selection of the power source 126 may be based on a variety of factors, such as its size, weight, cost, and / or power capacity. Basing the selection of the power source 126 on one attribute may adversely affect the operation or design of the inhalation device 100 with respect to other attributes of the power source 126. For example, a supply with the smallest physical size, lowest weight, and / or lowest cost may have insufficient capacity to power the electronic module 120 for a desired period of time (e.g., the normal operating life of the device 100). Conversely, a supply with sufficient capacity to power the electronic module 120 for a desired period of time may not fit within the space available in the top cap 102 and / or may be more expensive. Thus, the selection of the power source 126 may include balancing one or more of its technical and / or commercial attributes. Furthermore, the operation of the electronic module 120 may be configured to limit or manage power consumption from the power source 126, thereby allowing the selection of a smaller, less expensive power source that can reliably power the electronic module 120 for a desired period of time and under the desired operating conditions.

[0061] The electronic module 120 may have multiple power states, each having a respective power consumption level. For example, the electronic module 120 may be configured to operate in a system off state, a sleep state, and / or an active state. While the electronic module 120 is in the active state, the electronic module 120 may operate in one or more modes, such as a measurement mode, a data storage / data processing mode, a notification mode, and / or a connection mode. It will be appreciated that the electronic module 120 may operate in more than one mode at a time (e.g., the modes may overlap).

[0062] In the measurement mode, the controller of the electronic module 120 may power on the sensor system 128. The controller may cause the sensor system 128 to acquire pressure measurements, temperature values, humidity values, orientation values, etc. for a predetermined period of time (e.g., up to 60 seconds) and / or until the mouthpiece cover 108 is closed or no changes in measurements are detected. The controller may turn off one or more components of the electronic module 120 while the sensor system 128 is acquiring values ​​to further conserve power. The sensor system 128 may sample values ​​at any suitable rate. For example, the sensor system 128 may have a sampling rate of 100 Hz and thus a cycle time of 10 milliseconds. The sensor system 128 may generate a measurement complete interrupt after a measurement cycle is completed. The interrupt may wake up the controller or cause the controller to turn on one or more components of the electronic module 120. For example, after or while the sensor system 128 samples one or more pressure measurements, temperature values, humidity values, orientation values, etc., the controller may process and / or store the data and power off the sensor system 128 when the measurements are complete.

[0063] In the data storage / data processing mode, the controller may power on at least a portion of the memory in the electronic module 120. The controller may process readings from the sensor system 128 to calculate, estimate, or otherwise determine parameters (e.g., usage and / or storage conditions) and store the parameters in memory. The controller may also compare values ​​and / or parameters to one or more thresholds or ranges to assess how the inhalation device 100 is being used and / or the conditions under which the device 100 is being used. Depending on the results of the comparison, the controller may activate indicators (e.g., LEDs) to provide feedback to the user of the inhalation device 100. As described above, the electronic module 120 may operate in the measurement mode and the data storage / data processing mode simultaneously.

[0064] In the connected mode, the communication circuitry and memory may be powered on and the electronic module 120 may be "paired" with an external device such as a smartphone. The controller may retrieve data (e.g., sensor data and / or parameters derived from the sensor data) from the memory and wirelessly transmit the data to the external device. The controller may retrieve and transmit all of 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 determine which portions have already been transmitted to the external device and then transmit the portions that have not been transmitted previously. Additionally or alternatively, the external device may request specific data from the controller, such as any data collected by the electronic module 120 after a specific time or since the last transmission to the external device. The controller may retrieve specific data, if any, from the memory and transmit the specific data to the external device.

[0065] Additionally, when connected to an external device, the electronic module 120 may be configured to transmit Bluetooth special interest group (SIG) characteristics to manage access to data stored in the module 120. The Bluetooth SIG characteristics may include one or more of the following: the manufacturer of the inhalation device 100, the serial number of the inhalation device 100, the hardware revision number of the inhalation device 100, and / or the software revision number of the inhalation device 100. When connected to an external device, the electronic module 120 may retrieve data from memory and transmit the data to the external device.

[0066] The data stored in the memory of the electronic module 120 (e.g., the signal generated by the switch 130, the measurement readings obtained by the sensor system 128, and / or the parameters calculated by the controller of the electronic module 120) may be transmitted to an external device, which may process and / or analyze the data to determine usage parameters associated with the inhalation device 100. The data may include any usage parameters (e.g., usage events), which may include or indicate, for example, the use of the respective inhaler. In a relatively simple implementation, the at least one value may include "TRUE" when the use of the respective inhaler (e.g., an inhalation with the respective inhaler) has been determined, or may include "FALSE" when such use of the respective inhaler has not been determined. However, the usage parameters may include any combination of events described herein, such as, for example, a no inhale event, a low inhale event, a good inhale event, an over-inhale event, an exhale event, an actuation event, an error event, an under-use event, an over-use event, etc. Further, the usage parameters may include counting the number of uses of the inhalation device 100, measurements of airflow through the inhalation device 100, other measurements indicative of use of a medicament through the inhalation device 100 (such as the activation of a switch configured to detect use of the inhalation device 100 (e.g., when the mouthpiece cover is moved from a closed position to an open position) and / or a switch activated during priming of the inhaler, such as moving and / or opening a blister of medicament contained within the inhaler), feedback from one or more sensors configured to detect use of the inhalation device 100, and / or the activation of one or more buttons configured to be pressed during use of the inhalation device 100.

[0067] It will be further understood that the electronic module (e.g., processor) 120 may be configured to timestamp data (e.g., associate a timestamp with the data). For example, the electronic module 120 may include a local mean time clock and may associate a timestamp indicating the local mean time of the inhalation device 100 with data determined by the inhalation device 100. In another example, the electronic module 120 may operate as an internal counter. When operating as an internal counter, the electronic module 120 determines a relative count (as opposed to providing a mean solar time, e.g., local mean time) and associates the relative count with the determined data. For example, the electronic module 120 may start an internal counter (e.g., counting up from 0 indefinitely), such as when the electronic module 120 first wakes up from an energy saving sleep mode (e.g., after the mouthpiece cover is first opened). Thereafter, any timestamps generated by the electronic module 120 may be a relative time (or count) based on the internal counter. The electronic module 120 may periodically update the system clock every 250 microseconds (μs).

[0068] Additionally, software applications resident on the external device may generate feedback for the user based on the data received from electronic module 120. For example, the software applications may generate daily, weekly, or monthly reports, provide confirmation of error events or notifications, provide educational feedback to the user, and / or the like.

[0069] 5 is a diagram of an exemplary system 500 including an inhalation device 100, mobile devices 502, 504, 506, a public and / or private network 508 (e.g., any combination of the Internet, cloud networks, and / or the like), and a computer (e.g., a server) 512 associated with a healthcare provider, such as a hospital or hospital system, a health system, a medical group, a physician, a clinic, and / or a pharmaceutical company. The system 500 also includes a digital health platform (DHP) 510 residing on one or more servers and may include computer software configured to perform the functions described in connection with the DHP 510.

[0070] The mobile devices 502, 504, 506 may include a smartphone (e.g., an iPhone® smartphone, an Android® smartphone, or a Blackberry® smartphone), a personal computer, a laptop, a wireless-enabled media device (e.g., an MP3 player, a gaming device, a television, a media streaming device (e.g., Amazon Fire TV, Nexus Player, etc.), etc.), a tablet device (e.g., an iPad® handheld computing device), a Wi-Fi or wireless enabled television, a wearable device (e.g., an Apple Watch®), or any other suitable Internet protocol enabled device. The mobile devices 502, 504, 506 may include a processor, memory, communications circuitry (e.g., a transceiver), a speaker, a microphone, and / or a display screen. The mobile devices 502, 504, 506 may have a mobile application stored thereon that is configured to cause the mobile device to perform functions described herein, such as communicating with one or more inhalation devices 100 and / or DHPs 510, receiving data from the inhalers, processing and / or aggregating the received data, generating new data and / or alerts based on the data received from the inhalers, and / or generating feedback (e.g., alerts), such as notifications, GUIs, or audio feedback, based on the inhaler data.

[0071] Also provided may be a computer program comprising computer program code adapted to perform any of the methods and techniques described herein when the computer program is run on a computer. In a preferred embodiment, the computer program takes the form of a mobile application, at least in part, e.g., a mobile application residing on a mobile device. Also, in some examples, the computer program is provided in part as a mobile application and in part as DHP 510. The embodiments described herein for system 500 are applicable to the method and computer program. Furthermore, the embodiments described for the method and computer program are applicable to system 500.

[0072] Although described as a mobile device, system 500 may, in some examples, include a stationary device or a combination of mobile and stationary devices. Stationary devices include smart home interface devices, such as smart speakers, smart displays, smart home automation devices, and / or the like. Stationary devices include similar hardware and / or software (e.g., processors, memory, communications circuitry (e.g., transceivers), speakers, microphones, and / or display screens) as the mobile devices described herein, and are therefore configured to perform the functions described herein with respect to the mobile devices.

[0073] The mobile devices 502, 504, 506 may be configured to communicate with the inhalation device 100. The mobile devices 502, 504, 506 may also be configured to communicate with public and / or private networks 508, which may communicate with a computer associated with the DHP 510 and / or the healthcare provider 512. For example, the mobile devices 502, 504, 506 may include communications circuitry (e.g., a transceiver) and thus may be configured to transmit and / or receive RF signals via a Wi-Fi communications link, a Wi-MAX communications link, a Bluetooth or Bluetooth Smart communications link, a Near Field Communication (NFC) link, a cellular communications link, a television white space (TVWS) communications link, or any combination thereof. The mobile devices 502, 504, 506 may transfer data to the DHP 510 via the public and / or private networks 508, for example, using a dedicated API. For example, the mobile devices 502 , 504 , 506 may transmit usage data regarding one or more inhalation devices 100 to the DHP 510 .

[0074] As mentioned above, the inhalation device 100 may include communication circuitry 129, such as a Bluetooth radio, for transferring data to an external device (e.g., one or more of the mobile devices 502, 504, 506). Such data may be referred to as usage data, usage parameters, and / or usage events. The data may include any of the data described herein, such as signals generated by the switch 130, measurement readings obtained by the sensor system 128, and / or parameters calculated by the controller of the electronic module 120. The data may include any combination of no inhale events, low inhale events, good inhale events, over inhale events, exhale events, actuation events, error events, under-use events, over-use events, etc. The data may include a count of the number of uses of the inhalation device 100, measurements of airflow through the inhalation device 100, other measurements indicative of use of medicament through the inhalation device 100 (such as the actuation of a switch configured to detect use of the inhalation device 100 (e.g., when a mouthpiece cover is moved from a closed position to an open position) and / or a switch actuated during priming of the inhaler, such as moving and / or opening a blister of medicament contained within the inhaler), feedback from one or more sensors configured to detect use of the inhalation device 100, and / or actuation of one or more buttons configured to be pressed during use of the inhalation device 100. The data may be associated with a timestamp, for example as described herein.

[0075] The inhalation device 100 may receive data, such as program instructions, operation system changes, dosing information, alerts or notifications, receipt notifications, etc., from the mobile devices 502, 504, 506. Additionally, although illustrated as a single inhalation device 100, the system 500 may include any number of inhalation devices 100 associated with multiple different users. It should be noted that some users will have multiple inhalation devices 100 containing the same medication. For example, a single user may have multiple inhalation devices 100 containing rescue medication (e.g., holding them in different positions). Additionally, a single user may have multiple inhalation devices 100 containing a particular maintenance medication, such as when transitioning between refills. Additionally, the system 500 may be configured with multiple different users' inhalation devices 100. Thus, the system 500 is configured to communicate with multiple different inhalers associated with multiple different users via their respective mobile devices.

[0076] The mobile devices 502, 504, 506 may process and analyze the data to determine usage parameters associated with the inhalation device 100. For example, the mobile devices 502, 504, 506 may process the data to identify usage events such as no inhale events, low inhale events, good inhale events, over inhale events, exhale events, actuation events, error events, under-use events, over-use events, etc. The mobile devices 502, 504, 506 include a display device and software for visually presenting usage parameters and / or data related to the usage events via a GUI on the display device.

[0077] The mobile devices 502, 504, 506 may be configured to receive data (e.g., usage events) and associated timestamps (e.g., relative counts from an internal counter of the electronic module 120) from the inhalation device 100. The mobile devices 502, 504, 506 may determine a local mean time and time zone for the timestamp and associate the local mean time and time zone with the data (e.g., usage events). The mobile devices 502, 504, 506 may then transmit the data and associated local mean time and time zone to the DHP. The DHP may associate the data, local mean time, and time zone with the user. Alternatively or additionally, the mobile devices 502, 504, 506 may associate the data, local mean time, and time zone with the user and / or the DHP may determine the local mean time based on the timestamp received from the inhalation device 100.

[0078] The DHP is configured to receive and aggregate inhaler data (e.g., usage events) from multiple inhalers associated with multiple different users. In some examples, the DHP may reside on one or more servers and may include computer software configured to perform the functions described with respect to the DHP. For example, the DHP may include a dashboard application that may be accessible by a computer 512 associated with a healthcare provider, such as a hospital or hospital system, a health system, a medical group, a physician, a clinic, and / or a pharmaceutical company. In some examples, the dashboard application is a web application (e.g., a web portal). For example, the DHP is also configured to provide data, such as inhaler data, to clinicians and physicians through use of the dashboard application (e.g., via a REST API).

[0079] The DHP 510 is configured to receive and aggregate data from multiple inhalation devices 100, which may be associated with multiple different users. For example, the DHP 510 is configured to receive and store inhaler data from mobile devices 502, 504, 506 (e.g., patient-facing mobile applications). The inhaler data may include any data described with reference to the inhalers described herein, such as usage events, error events, inhalation profiles, associated timestamps, medication types, etc. The DHP 510 is configured to analyze and manipulate the data. For example, the DHP 510 aggregates data across multiple inhalation devices from which it receives data, and the DHP 510 may then analyze the aggregated data, for example, to determine one or more metrics, provide feedback, etc. Furthermore, the DHP 510 is also configured to provide the data (e.g., or analytical information based on the data) to a user (e.g., via the mobile devices 502, 504, 506) or to a computer 512 associated with a healthcare provider (e.g., via a dashboard application). The inhaler data may include any of the data described with reference to the inhalers described herein.

[0080] The inhaler data may be associated with the inhalation device 100 and / or a user profile, for example, at the mobile device 502, 504, 506 and / or the DHP 510. A user profile may be associated with multiple inhalation devices 100 of the same and / or different drug types. The DHP 510 may also de-identify (e.g., disassociate) the inhaler data from a particular user profile, and the DHP 510 may perform analysis on the de-identified data related to the inhalation device 100. Although described as receiving the inhaler data from the mobile device 502, 504, 506, in some examples, the DHP 510 may receive the data directly from the inhalation device 100 itself, such as when the communication circuitry of the inhalation device 100 includes a cellular chipset that can communicate directly with the DHP 510.

[0081] Each time data is transferred from the inhalation device 100 to an external device, such as one or more of the mobile devices 502, 504, 506, the power source 126 may power one or more electrical components in the electronic module 120, such as the communication circuitry 129. Thus, the frequency of data transfer from the inhalation device 100 may affect the overall power consumption and the ability of the power source 126 to power the electronic module 120 for a desired period of time. That is, more frequent data transfers to external devices and / or data transfers to multiple external devices may increase the power requirements of the electronic module 120 and reduce the functional life of the power source 126. Therefore, the system 500 may be configured to limit the number of times the inhalation device 100 transmits new data to an external device (e.g., limit the transmission to a single data transfer). Furthermore, in some examples, the inhalation device 100 may be prevented from transmitting data more than a limited number of times (e.g., more than once). After the data is transferred from the inhalation device 100 to the external device, the DHP 510 may be configured to receive the data from the mobile device and transmit the data to other authorized mobile device(s) associated with the medication and user in the system 500. Additionally, in some examples, the mobile device (e.g., a mobile application residing on the external device) may check the system 500 (e.g., the DHP 510) for information before requesting data from the inhalation device 100, e.g., to limit the energy usage of the inhalation device 100. For example, in some examples, when the mobile device and the inhalation device enter a connected mode, the mobile device may first request new data about the inhalation device 100 from the DHP 510 (e.g., as described herein) before requesting data from the inhalation device 100. Thus, the mobile device ensures that it has the most recent updated data sent by the inhalation device 100 before the mobile device requests new data from the inhalation device 100.

[0082] In one example, an inhalation device 100 may be provided to a child with asthma. The child may have a mobile device 502, and the child's parent may have mobile devices 504, 506. Each of the mobile devices 502, 504, 506 may include a mobile application configured to process and / or display data collected from the inhalation device 100. The mobile application on the mobile device 504, 506 may enable the child's parent to monitor conditions or parameters associated with the child's use of the inhalation device 100. The mobile application on the mobile device 502 may enable the child to do the same. Thus, data from the inhalation device 100 may need to be transferred to three separate external devices.

[0083] When data is transferred directly from the inhalation device 100 to the mobile device 502, 504, 506, power consumption for wireless transmission may increase (e.g., increase by a factor of three) compared to communicating with a single external device. This increased power consumption may shorten the functional life of the power source 126 beyond the expected life of the inhalation device 100 (e.g., shorten the functional life beyond the period during which a user is expected to receive medication from the inhalation device 100). Thus, to extend the life of the power source 126, one or more of the electronic module 120, the mobile application present on the mobile device 504, and / or the DHP 510 may be configured to limit the number of times data may be transferred from the electronic module 120 to an external device (e.g., limited to a single transfer of data from the inhalation device 100).

[0084] For example, referring again to FIG. 5, a child may be prescribed a medication that can be administered via the inhalation device 100. The child's mother may download a mobile application onto her mobile device, such as the mobile device 504. The mobile application may enable the mobile device 504 to wirelessly connect with the inhalation device 100 and receive data collected by the electronic module 120. Such data may indicate when a dose has been delivered from the device 100. The mobile application may also store the child's prescribed dosing regimen. Thus, the mobile application may enable the child's mother to monitor when and how often the child is using the inhalation device 100 and whether the child is complying with the dosing regimen. The child and the child's father may similarly download mobile applications for their respective mobile devices 502, 506. However, to extend the life of the power supply 126 of the electronic module 120, the system 500 may be configured to limit the transfer of data from the electronic module 120 to a single transfer of data (e.g., the transfer of data to only one of the mobile devices 502, 504, 506).

[0085] For example, in some embodiments, when a mobile device such as mobile device 504 is within communication range of the electronic module 120 of the inhalation device 100, the mobile device 504 (e.g., a mobile application resident thereon) may send a request for data to the inhalation device 100. The request may include an indication of the most recent data stored by the mobile device 504 (e.g., a timestamp of the most recent data from the inhalation device 100 stored on the mobile device 504). If the inhalation device 100 has more recent data (e.g., data with a more recent timestamp than that indicated by the request), the inhalation device 100 may send the more recent data to the mobile device 504. The mobile device 504 that receives the more recent data may then upload that data to the DHP 510. Other mobile devices that did not receive the more recent data from the inhalation device 100 (e.g., mobile devices 502, 506, etc.) may then receive the more recent data from the DHP 510, for example, as described below. For example, when a user logs into a mobile application on another mobile device, the mobile application may cause the mobile device to retrieve data (e.g., all recent data) from the DHP 510 instead of from the inhalation device 100. Thus, the mobile applications on the other mobile devices do not need to request data from the inhalation device 100 because those mobile devices are already receiving data from the DHP 510.

[0086] Thus, the inhalation device 100 may be configured to limit the number of times the inhalation device transfers data to a mobile device (e.g., the mobile device may be any mobile device and may be a different mobile device between each data transfer). In this example, the mobile device is limited to a single transfer of the stored data because, for example, once the data is provided to a single external device, the external device transfers the data to the DHP 510, which then forwards the data to all other authorized external devices. However, if the mobile device were not limited to a single transfer of the stored data, the same instance of the stored data may be transferred to the DHP 510 multiple times, which may adversely affect the integrity and / or validity of the data in the DHP 510 (e.g., because multiple instances of the same data may exist in the DHP 510).

[0087] More specifically, the DHP 510 may be configured to enable and possibly initiate the transfer of data from the mobile devices 502, 504, 506. For example, the DHP 510 may expose a REST API to the processors and / or mobile applications present on the mobile devices 502, 504, 506. The mobile devices 502, 504, 506 may send any data related to the inhalation device 100 that has not yet been uploaded to the DHP 510, along with any combination of an indication of an associated user and / or a timestamp for the data (which may include the local time and time zone of the mobile device). In some examples, the mobile devices 502, 504, 506 may be configured to send inhalation data (or an indication that there is no new inhalation data) to the DHP 510 periodically, such as every 15 minutes. The DHP 510 may also store the input data from the computer 512. The DHP 510 may receive patient consent via each mobile device 502, 504, 506.

[0088] The DHP 510 may transmit data, such as inhaler data, to one or more of the mobile devices 502, 504, 506. For example, the DHP 510 may receive data from one mobile device and then transmit the data to other mobile device(s) associated with the user, such as if the other mobile device does not already have the inhaler data. In some examples, the mobile devices 502, 504, 506 may send a request for all new inhaler data associated with a user to the DHP 510 (e.g., periodically, such as every 15 minutes). The request may include an indication of the user and at least one of the inhaler or medication type (e.g., rescue medication type or maintenance medication type). The request may also include an indication of the last synchronization time between the mobile device and the inhaler, regardless of whether any new inhaler-related data has been communicated from the inhaler to the mobile device. The last synchronization time of the mobile device may indicate the most recent time the inhaler was connected to the mobile device, regardless of whether any new inhaler-related data has been communicated from the inhaler to the mobile device. The DHP 510 may receive the request, determine the user, inhaler, and / or medication type, and determine the last synchronization time between the mobile device and the inhaler. The DHP 510 may then determine whether it has stored any data (e.g., usage events) that are later in time than the synchronization time indicated by the request by comparing an associated timestamp to the last synchronization time provided in the request. If there is data for that inhaler that is later than the last synchronization time, the DHP 510 is configured to transmit that data and the associated timestamp to the mobile device (e.g., along with any combination of data indicative of the associated user, inhaler, and / or medication type).The data transmitted by the DHP 510 may include data from the inhaler, such as the usage event, along with a timestamp of the data (e.g., including the local average time and time zone of the event), inhaler information, such as data indicating the medication type and / or administration, and data indicating the user associated with the event.

[0089] Additionally, in some examples, the DHP 510 may return additional data regarding the user and / or medication, such as profile information about the user, prescription order information, user preferences, survey responses, etc. For example, if information other than inhaler-related data, such as usage events, is received by the mobile device, the request may include an additional field indicating the last synchronization time between the mobile device and the inhalation device 100 or between the mobile device and the DHP 510. The DHP 510 may then determine whether it has stored any other data, such as those described above, that is later in time than the synchronization time indicated by the request, and if so, may transmit that other data and associated timestamps to the mobile device (e.g., in combination with any combination of associated user, inhaler, and medication type).

[0090] Thus, the system 500 may be configured to limit the number of times the inhalation device 100 must communicate its data to the mobile device, while also ensuring that multiple mobile devices 502, 504, 506 associated with the inhalation device 100 have up-to-date data associated with the inhalation device 100 and / or user, regardless of the number of mobile devices 502, 504, 506 associated with the inhalation device 100 and / or user. This is particularly pertinent in instances where the mobile device is configured to periodically send to the DHP new data received from the inhalation device 100 and / or an indication of the last synchronization between the mobile device and the inhalation device 100, and also to periodically send to the DHP a request for new data not already stored on the mobile device.

[0091] Additionally, the DHP 510 may cause a computer 512 associated with the healthcare provider to provide the inhaler data to physicians and healthcare professionals so that they can review the inhaler data specific to the program to which the patient has subscribed. In one example, the DHP 510 causes a computer 512 associated with the healthcare provider to provide the inhaler data via a graphical user interface (GUI) that is presented on a display device associated with the healthcare provider's computer.

[0092] The DHP 510 may define any number of programs, which may be configured and modified by the healthcare provider in some examples. In providing inhaler data to the healthcare provider, the DHP 510 may generate alerts (e.g., generate and provide a GUI) specific to the particular program associated with the healthcare provider. A program defines a set of criteria, such as the type of medication (e.g., any combination of rescue medication and / or maintenance medication), the particular patient and therefore their available inhalers, other users of the program (e.g., particular physicians, practice groups, and / or administrators), and the type of data (e.g., charts, event tables, usage summaries, etc.) that will be presented to the healthcare provider. The healthcare provider may configure and establish any number of programs using the DHP 510. Furthermore, a particular patient and their inhaler may be associated with any number of unique programs. In some examples, the programs are stored and managed by the DHP 510, and a computer 512 associated with the healthcare provider is configured to access data regarding each program from the DHP 510 using an application, such as a dashboard or web application. In such an example, once a program is established, the DHP 510 is configured to receive inhaler data associated with the program, analyze and manipulate the inhaler data to the extent necessary, and provide the program data to the healthcare provider (e.g., via a dashboard). The program data may include inhaler data specific to the configuration of a particular program, and additional data derived from the inhaler data, e.g., as described in more detail below. For example, the DHP 510 may enable a GUI, such as described herein, on a computer 512 associated with the healthcare provider to present the program data to the healthcare provider.

[0093] For example, the DHP 510 may include a dashboard application that may be accessible by a computer 512 associated with a healthcare provider. In some examples, the dashboard application is a web application (such as a web portal). For example, the DHP 510 may be configured to provide data, such as inhaler data, to clinicians and physicians through use of the dashboard application (e.g., via a REST API). The DHP 510 may cause a computer 512 associated with a healthcare provider to provide the inhaler data to physicians and healthcare professionals so that they can review the inhaler data specific to the program to which the patient has subscribed. In one example, the DHP 510 may cause a computer 512 associated with a healthcare provider to provide the inhaler data via a graphical user interface (GUI) presented on the healthcare provider's computer.

[0094] Alternatively or additionally, in some examples, after the mobile device 504 receives more recent data from the inhalation device 100 and uploads the data to the DHP 510, the mobile application may be configured to cause the mobile device to send a notification to the inhalation device 100 indicating that the inhalation data has been uploaded to the DHP 510. Thus, upon receiving a notification that the inhalation data has been uploaded to the DHP 510, the inhalation device 100 may be configured not to upload the data to another mobile application even if a request for that data is received. However, the mobile application may be configured to send to the mobile device inhalation data that is later in time than the data uploaded to the DHP 510.

[0095] Alternatively or additionally, in some examples, the system 100 may be configured to allow the inhalation device 100 to transfer data only to one single mobile device. For example, when a mobile application on the mobile device 504 (e.g., initially) connects to and / or receives data from the inhalation device 100, the inhalation device 100 may receive and store an ID associated with the mobile device 504. After receiving the ID, the inhalation device 100 may be limited to connecting to and transferring data to the mobile device 504 and / or any other device having the same ID. If other external devices, such as mobile devices 502, 506, attempt to connect to the inhalation device 100, the inhalation device 100 will not transfer data if such devices have different IDs. Thus, the electronic module 120 may conserve power, for example, by limiting the instances in which it connects to external devices and transmits data collected by the sensor system 128.

[0096] All or a portion of the data transferred to the mobile device 504 may be communicated by the device 504 to the DHP 510. The data may be stored in the DHP 510, where it may be later accessed or retrieved by a mobile application on the mobile device 504 and / or by a computer 512 associated with the healthcare provider. The data may also be accessed or retrieved by the respective mobile applications on the mobile devices 502, 506. Thus, the child and the child's father may still be able to monitor usage and / or other conditions associated with the inhalation device 100 on their respective mobile devices 502, 506, even though the inhalation device 100 is restricted to connecting to and / or transferring data with the mobile device 504.

[0097] Further, in some examples, for example, when the inhalation device 100 is in a connected mode, the inhalation device 100 may limit how often it communicates data with an external device (e.g., a mobile device). This may allow the inhalation device 100 to conserve battery power, for example, while in a connected mode. The communication protocol enabled by the inhalation device 100 may include a parameter that defines, for example, how often requests for data are permitted while the inhalation device 100 is in a connected mode. The parameter may, for example, allow the inhalation device 100 to skip a connection event without the external device dropping the connection, and thus the inhalation device 100 may skip a connection event and still remain in a connected mode. In such examples, the inhalation device 100 may set this parameter to its maximum value. For example, if the inhalation device 100 communicates using BLE, the inhalation device 100 may configure the parameter "connSlaveLatency" to a maximum value (e.g., every 2 seconds, every 4 seconds, etc.).

[0098] Further, in some examples, the inhalation device 100 does not include an actuator, button, or switch for initiating the pairing process with the mobile device. However, the inhalation device 100 may include other means for facilitating the pairing process. For example, the inhalation device 100 may include a barcode, such as a Quick Response (QR) code 160. Although described as a QR code, other types of barcodes may be used. The use of a QR code to initiate the pairing process may further reduce the required battery / power consumption of the electronic module 120 of the inhalation device 100. Further, while the QR code 160 is illustrated as being located on the top of the top cap 102 of the inhalation device 100, in other examples, the inhalation device 100 may include a QR code located elsewhere on the inhalation device 100, such as on the main housing 104 or on the mouthpiece cover 108. The mobile device may include a camera, and a mobile application present on the mobile device may be configured to access the camera and read the QR code 160.

[0099] The QR code 160 may include (e.g., may be coded to indicate) various types of information associated with the inhalation device 100. The QR code 160 may include a BLE passkey that is unique to the inhalation device 100. Upon reading or scanning the QR code 160 with the camera, the mobile application may determine the BLE passkey associated with the device 100 and complete the authentication process, thereby allowing communication with the electronic module 120 using the BLE passkey. For example, if the communication session is subsequently lost because the inhalation device 100 moves out of range, the mobile device may be configured to automatically pair with the electronic module 120 using the BLE passkey without using the QR code 160 when the inhalation device 100 returns within range.

[0100] Additionally, in some examples, the QR code 160 may include an indication of the type of inhalation device 100 (e.g., drug type, number of doses, strength, dosing schedule, etc.). Table 1 provides non-limiting examples of identifiers that may be included in the QR code 160 for various inhalation devices 100. [Table 1] TIFF0007638951000001.tif135169

[0101] As shown in Table 1, the identifier further indicates the dose strength and the total dose count of the inhaler before use. As described above, a mobile application resident on the mobile device may use the identifier information from the identifier in combination with the usage information to control the user interface of the mobile device to provide notifications when the label recommended dose is exceeded. Alternatively or additionally, the mobile application resident on the mobile device may use the total dose count of the inhaler before use and the usage information to determine the number of doses remaining in each inhalation device 100.

[0102] The QR code 160 on the inhalation device 100 may further include a security key, for example in the form of a series of alphanumeric characters, for example to prevent unauthorized users from accessing the respective inhalation device 100. A mobile application present on the mobile device may be able to decrypt the respective encrypted data once the mobile application is provided with the security key, but may not be able to decrypt the respective encrypted data before the mobile application is provided with the security key. More generally, the security key may be included in the respective identifier.

[0103] In a non-limiting example, the system is configured to restrict one or more, eg, each, of the inhalers included in the system to a single user account.

[0104] In such an example, a passkey provided, for example, in a QR code, may enable synchronization between each inhalation device 100 and the system's mobile application. The passkey, and thus the usage parameter data (e.g., inhalation and / or usage data) from each inhalation device may be public. This public inhalation data may not be associated with a particular subject until synchronized with a single user account.

[0105] Because the system is configured to limit each inhaler to being associated with a single user account, each inhaler may be prevented from being synchronized with another user account, for example in the situation where the inhaler is lost or stolen, thus preventing third parties from obtaining usage parameter data that does not belong to them.

[0106] Thus, the mobile application can determine the type of the inhalation device 100 upon receiving the QR code 160 (e.g., drug type, dose strength, and dose number) and prior to the first use of the inhalation device 100 by the user. For example, the mobile application may receive (e.g., capture) an image of the QR code using the camera of the mobile device. The mobile application may then decode the image of the QR code to obtain the data stored within the QR code. In some examples, the QR code 160 may comprise a multi-digit alphanumeric code, such as a six-digit code (e.g., ssm060, aaa200, etc.) that indicates the type of the inhalation device 100. For example, the multi-digit alphanumeric code may be a unique drug product identifier (e.g., product ID) of the inhalation device 100. Thus, the QR code 160 may directly communicate the type of the inhalation device 100 (e.g., drug type, dose number, strength, dose schedule, etc.) via the multi-digit alphanumeric code provided via the QR code 160 (e.g., thus the mobile application does not need to access a website using the QR code 160 to obtain the type of the inhalation device). A multi-digit alphanumeric code of "AAA030," for example, may indicate that the drug type is albuterol, the strength is 117 mcg, and the number of doses is 30.

[0107] In some examples, the BLE passkey provided via the QR code 160 may include, for example, a multi-digit alphanumeric character. Additionally, in some embodiments, the QR code 160 may not directly reveal information to the mobile application regarding the type of medication, number of doses, strength, dosing schedule, etc. of the inhalation device 100. Rather, the QR code 160 may comprise information that may be used by the mobile application to obtain such information regarding the inhalation device 100 from a remote device (e.g., a cloud-based system such as a remote server).

[0108] Additionally, in some examples, the QR code 160 may include any combination of the serial number of the inhalation device 100, the hardware revision number of the inhalation device 100, and / or the software revision number of the inhalation device 100. Additionally, although described with reference to the QR code 160, the inhalation device 100 may include any code (e.g., a barcode) indicative of the type of inhalation device 100, a communication passkey (e.g., a BLE passkey), the name of the manufacturer of the inhalation device 100, the serial number of the inhalation device 100, the hardware revision number of the inhalation device 100, the software revision number of the inhalation device 100, and / or the like.

[0109] Upon receiving the QR code 160, the mobile application may determine details of the inhalation device 100 (e.g., drug type, number of doses, strength, dosing schedule, etc.), such as directly through the multi-digit alphanumeric code provided via the QR code 160. Alternatively or additionally, in some examples, the mobile application may be configured to send a request (e.g., including a multi-digit alphanumeric code) to the DHP 510 for details about the inhalation device 100 (e.g., drug type, number of doses, strength, dosing schedule, etc.). This may be particularly important, for example, when a mislabeling issue may arise, where the inhalation device 100 is mislabeled with an incorrect drug type. The use of the QR code 160, for example, allows accurate details about the inhalation device 100 to be obtained by the mobile application before the user uses the inhalation device 100. This may help prevent issues related to, for example, incorrect dosing reminders based on incorrect dosing schedules, incorrect refill warnings, etc. (which may otherwise be determined based on incorrect drug labeling on the inhalation device 100). Further, in some examples, the mobile application may determine that a user associated with the mobile application is not prescribed the medication and / or dosage strength indicated by the QR code. For example, the mobile application may transmit the medication type or strength of the inhaler indicated by the QR code to the DHP 510 and, in response, may receive an indication of the user's compatibility with the inhaler strength or medication type from the cloud-based server (e.g., a direct compatibility or non-compatibility message, or an indication of the strength and medication type associated with the user). For example, the mobile application may request and receive the user's prescription information from the DHP 510. The mobile application may then generate an alert (e.g., a GUI displayed on the mobile device and / or at a computer associated with the HCP) indicating that the user has an incorrect inhaler based on either the medication type or strength as indicated by the QR code.Furthermore, in such cases, the mobile application may reject the pairing process with the inhalation device 100.

[0110] Additionally, in some examples, the mobile application may be used with certain, but not all, types of inhalation devices. Thus, if the information provided by the QR code 160 indicates that the inhalation device 100 is not an inhalation device that is compatible with the mobile application, the mobile application may display an error message. Additionally, the mobile application may provide a link to a mobile application store to download the correct mobile application for the type of inhalation device 100. For example, if the mobile application determines (e.g., based on the QR code 160 or the multi-digit alphanumeric code) that the inhalation device is not compatible with the mobile application, the mobile application may reject the pairing process between the mobile device and the inhalation device 100 (e.g., prior to data transfer or first use of the inhalation device 100). If the mobile application determines (e.g., based on the QR code 160 or the multi-digit alphanumeric code) that the inhalation device is compatible with the mobile application, the mobile application may allow or enable the pairing process between the inhalation device 100 and the mobile device.

[0111] Figure 6 is an example air flow rate versus pressure graph 600. The air flow rates and profiles shown in Figure 6 are merely exemplary, and the determined flow rates may depend on the size, shape, and design of the inhalation device 100 and its components.

[0112] The electronic module 120 may generate data (e.g., usage events) by, for example, comparing the signals received from the sensor system 128 and / or the determined airflow indicator to one or more thresholds or ranges as part of an evaluation of how the inhalation device 100 is being used and / or whether the use is likely to result in the delivery of a full dose of medication. For example, if the determined airflow indicator corresponds to an inhalation having an airflow rate below a certain threshold, the electronic module 120 may determine that there was no inhalation or that there was an insufficient inhalation from the mouthpiece 106 of the inhalation device 100. If the determined airflow indicator corresponds to an inhalation having an airflow rate above a certain threshold, the electronic module 120 may determine that there was an excessive inhalation from the mouthpiece 106. If the determined airflow indicator corresponds to an inhalation having an airflow rate within a certain range, the electronic module 120 may determine that the inhalation is "good" or will result in the delivery of a full dose of medication. The electronic module 120 may associate a timestamp with the data.

[0113] The pressure measurements and / or the calculated inhalation airflow indicators may indicate the quality or strength of an inhalation from the inhalation device 100. For example, when compared to a particular threshold or range of values, the values ​​and / or indicators may be used to classify an inhalation as a particular type of event, such as a good inhalation event, a low inhalation event, a no inhalation event, or an excessive inhalation event. The classification of an inhalation may be a usage parameter stored as personalized data for the subject.

[0114] A no-inhale event may be associated with a pressure measurement reading and / or airflow indicator below a particular threshold, such as an airflow rate of 30 Lpm or less. A no-inhale event may occur when the subject does not inhale through the mouthpiece 106 after opening the mouthpiece cover 108 and during the measurement cycle. A no-inhale event may also occur if the subject's inhalation effort is insufficient to ensure proper delivery of the medicament through the flow passage 119 (e.g., if the inhalation effort generates insufficient airflow rate to activate the deagglomerator 121, thereby aerosolizing the medicament in the dosing cup 116).

[0115] A low inhalation event may be associated with a pressure measurement and / or airflow indicator within a particular range, such as an airflow rate of greater than 30 Lpm and less than or equal to 45 Lpm. A low inhalation event may occur when a subject inhales through the mouthpiece 106 after opening the mouthpiece cover 108 and the subject's inhalation effort results in at least a partial dose of the medication being delivered through the flow passage 119. That is, the inhalation need only be sufficient to activate the deagglomerator 121 such that at least a portion of the medication is aerosolized from the dosing cup 116.

[0116] A good inhalation event may be associated with a pressure measurement and / or airflow indicator that exceeds a low inhalation event, such as an airflow rate of greater than 45 Lpm and less than or equal to 200 Lpm. A good inhalation event may occur when a subject inhales through the mouthpiece 106 after opening the mouthpiece cover 108 and the subject's inhalation effort is sufficient to ensure proper delivery of the medication through the flow passage 119 (e.g., when the inhalation effort generates sufficient airflow to activate the deagglomerator 121 and aerosolize a dose of the medication in the dosing cup 116).

[0117] An excessive inhalation event may be associated with a pressure measurement and / or airflow indicator that exceeds a good inhalation event, such as an airflow rate of more than 200 Lpm. An excessive inhalation event may occur when the subject's inhalation effort exceeds the normal operating parameters of the inhalation device 100. An excessive inhalation event may also occur if the subject's inhalation effort is within normal ranges but the device 100 is not properly positioned or held during use. For example, if the vent is blocked or obstructed (e.g., by a finger or thumb) while the subject is inhaling through the mouthpiece 106, the calculated airflow rate may exceed 200 Lpm.

[0118] Any suitable threshold or range may be used to classify a particular event. Some or all of the events may be used. For example, a no inhalation event may be associated with an airflow rate of 45 Lpm or less, and a good inhalation event may be associated with an airflow rate of greater than 45 Lpm and less than or equal to 200 Lpm. Thus, a low inhalation event may not be used at all.

[0119] The pressure measurements and / or the calculated airflow indicator may indicate a direction of flow through the flow passage 119 of the inhalation device 100. For example, if the pressure measurements reflect a negative change in pressure, the reading may indicate air flowing out of the mouthpiece 106 via the flow passage 119. If the pressure measurements reflect a positive change in pressure, the reading may indicate air flowing into the mouthpiece 106 via the flow passage 119. Thus, the pressure measurements and / or airflow indicator may be used to determine if the subject is exhaling into the mouthpiece 106, which may indicate that the subject is not using the device 100 properly.

[0120] The inhalation device 100 may include a spirometer or similarly operating device that allows for the measurement of lung function indicators. For example, the inhalation device 100 may perform measurements to obtain indicators related to the 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 a pressure transducer, ultrasound, or a water flow meter to detect changes in the volume of air inhaled and / or exhaled.

[0121] Data collected from or calculated based on use of the inhalation device 100 (e.g., pressure indices, airflow indices, pulmonary function indices, dosing confirmation information, etc.) may be computed and / or evaluated (e.g., partially or wholly) via an external device. More specifically, the wireless communication circuitry 129 in the electronic module 120 may include a transmitter and / or a receiver (e.g., a transceiver) as well as additional circuitry.

[0122] For example, the wireless communication circuitry 129 may include a Bluetooth chipset (e.g., a Bluetooth Low Energy chipset), a ZigBee chipset, a Thread chipset, etc. Thus, the electronic module 120 may wirelessly provide data such as pressure measurements, airflow indices, lung function measurements, administration confirmation information, and / or other aspects of the use of the inhalation device 100 to the mobile device. The electronic module 120 may also transmit a timestamp associated with the data. The data may be provided to the external device in real time to enable exacerbation risk prediction based on personalized data about the subject, such as time of use, real-time data from the inhalation device 100 indicating how the inhalation device 100 is being used, and real-time data about the subject's lung function and / or medical treatment. The external device may include software to process the received information and provide compliance and adherence feedback to the subject via a graphical user interface (GUI), such as via the mobile device or via a computer associated with the HCP.

[0123] The airflow index may include personalized data collected in real time from the inhalation device 100, such as one or more of the average inhalation / exhalation flow rate, the peak inhalation / exhalation flow rate (e.g., maximum inspiration received), the inhalation / exhalation volume, the time to peak inhalation / exhalation, and / or the duration of inhalation / exhalation. The airflow index may indicate the direction of flow through the flow path 119. That is, a negative change in pressure may correspond to inhalation from the mouthpiece 106, and a positive change in pressure may correspond to exhalation into the mouthpiece 106. When calculating the airflow index, the electronic module 120 may be configured to remove or minimize any distortions caused by environmental conditions. For example, the electronic module 120 may re-zero to account for changes in atmospheric pressure before or after calculating the airflow index. One or more pressure measurements and / or airflow index may be time-stamped and stored in the memory of the electronic module 120.

[0124] In addition to the airflow index, the inhalation device 100 or another computing device may use the airflow index to generate additional data. For example, the controller of the electronic module 120 of the inhalation device 100 may convert the airflow index into other indices indicative of the subject's lung function and / or lung health as understood by a physician, such as a peak inspiratory flow index, a peak expiratory flow index, and / or a forced expiratory volume in 1 second (FEV1). The inhaler electronic module 120 may use a mathematical model, such as a regression model, to determine a measure of the subject's lung function and / or lung health. The mathematical model may identify a correlation between the total volume of inhalation and FEV1. The mathematical model may identify a correlation between the peak inspiratory flow and FEV1. The mathematical model may identify a correlation between the total volume of inhalation and peak expiratory flow. The mathematical model may identify a correlation between the peak inspiratory flow and peak expiratory flow.

[0125] 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 techniques of the appended claims. In the claims, the word "comprising" does not exclude other elements or steps, and the indefinite articles "a" or "an" do 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 interpreted as limiting the scope.

Claims

1. 1. A system comprising: a server having a processor, a memory, and a communication circuit; an inhaler comprising a mouthpiece, a medicament, and an electronic module, the electronic module comprising a processor, memory, and communication circuitry; The system further comprises: a first computer readable storage medium present on a first mobile device; The first computer readable storage medium comprises: The computer-executable instructions, when executed by a processor of the first mobile device, cause the processor of the first mobile device to: sending a request for inhalation data to the inhaler; receiving the inhalation data from the inhaler, the inhalation data being associated with a timestamp; and transmitting the inhalation data and a time stamp to the server; The system further comprises: a second computer readable storage medium present on a second mobile device; The second computer readable storage medium comprises: The computer-executable instructions, when executed by a processor of the second mobile device, cause the processor of the second mobile device to: sending a request for inhalation data of the inhaler to the server in response to detecting a user login event at the second mobile device and prior to causing the second mobile device to send the request for inhalation data to the inhaler; and receiving the inhalation data for the inhaler from the server in response to the request. A system characterized by:

2. The second computer-readable storage medium, and configured to cause the second mobile device to transmit to the server a product identifier (ID) associated with the inhaler or a patient ID associated with a patient of the inhaler before the second mobile device receives the inhalation data of the inhaler from the server. The system of claim 1 .

3. The second computer readable storage medium, in response to entering a connection mode with the inhaler, causes the processor of the second mobile device to: and causing the second mobile device to transmit a request for inhalation data to the inhaler before causing the second mobile device to transmit the request to the server. The system of claim 1 .

4. The system is configured to limit the number of times the inhaler transmits the inhalation data to any mobile device to one. The system of claim 1 .

5. The second computer-readable storage medium, and periodically sending to the server a request comprising a timestamp of the latest inhalation data of the inhaler stored on the second mobile device. The system of claim 1 .

6. the inhaler further comprising a quick response (QR) code; the first mobile device further comprises a camera; The first computer-readable storage medium may be configured to cause the processor of the first mobile device to: receiving an image of the QR code of the inhaler using the camera of the first mobile device; determining a product identifier (ID) for the inhaler based on the image of the QR code; determining a dosing schedule for the inhaler using the product ID; and generating an alert indicating an upcoming scheduled dose based on the dose schedule of the inhaler. The system of claim 1 .

7. the inhaler further comprising a quick response (QR) code; the first mobile device further comprises a camera; The first computer-readable storage medium may be configured to cause the processor of the first mobile device to: receiving an image of the QR code of the inhaler using the camera of the first mobile device, the QR code providing a product identifier (ID) of the inhaler; determining one or more of a medication type or a strength of the medication based on the product identifier; determining that the inhaler is incompatible with the first computer readable storage medium or the user based on the medication type or strength of the inhaler; and generating an error message on a display device of the first mobile device based on the inhaler being incompatible with the first computer-readable storage medium or the user. The system of claim 1 .

8. The first computer-readable storage medium may be configured to cause the processor of the first mobile device to: transmitting the medication type or strength of the inhaler to the server; and receiving from a server an indication of the user's compatibility with the medication type or strength of the inhaler. The system of claim 7.

9. The first computer-readable storage medium may include a processor for executing a program for executing a program on the first mobile device. and configured to reject a pairing process between the inhaler and the first mobile device based on the inhaler being incompatible with the first computer-readable storage medium. The system of claim 7.

10. the inhaler further comprises a Quick Response (QR) code, but the inhaler does not comprise an actuator, button, or switch for initiating a communication pairing process with the first mobile device; The system of claim 1 .

11. The first computer-readable storage medium may be configured to cause the processor of the first mobile device to: receiving an image of the QR code of the inhaler using a camera of the first mobile device; determining a communication passkey unique to the inhaler based on the QR code; and transmitting the communications passkey to an electronic module of the inhaler to enable communications between the electronic module and the first computer readable storage medium. The system of claim 10.

12. the communication passkey comprises a product identifier and a Bluetooth Low Energy (BLE) passkey; The system of claim 11.

13. A system comprising: a server having a processor, a memory, and a communication circuit; an inhaler comprising a mouthpiece, a medicament, and an electronic module, the electronic module comprising a processor, memory, and communication circuitry; The system further comprises: a first computer readable storage medium present on a first mobile device; The first computer readable storage medium comprises: The computer-executable instructions, when executed by a processor of the first mobile device, cause the processor of the first mobile device to: sending a request for inhalation data to the inhaler; receiving the inhalation data from the inhaler, the inhalation data being associated with a timestamp; and transmitting the inhalation data and a time stamp to the server; The system further comprises: a second computer readable storage medium present on a second mobile device; The second computer readable storage medium comprises: The computer-executable instructions, when executed by a processor of the second mobile device, cause the processor of the second mobile device to: in response to entering a connection mode with the inhaler and prior to causing a second computer-readable storage medium to transmit a request for inhalation data to the inhaler, transmitting a request to the server including a timestamp of the inhaler's most recent inhalation data stored in the second computer-readable storage medium; and receiving the inhalation data for the inhaler from the server in response to the request, wherein the timestamp associated with the inhalation data is later than the timestamp of the most recent inhalation data for the inhaler stored on the second computer readable storage medium. A system characterized by:

14. The system is configured to limit the number of times the inhaler transmits the inhalation data to any mobile device to one. The system of claim 13.

15. The second computer-readable storage medium, comprising: and transmitting to the server a product identifier (ID) associated with the inhaler or a patient ID associated with a patient of the inhaler before the second computer readable storage medium receives the inhalation data of the inhaler from the server. The system of claim 13.

16. The second computer-readable storage medium, comprising: and periodically sending to the server a request comprising the timestamp of the latest inhalation data of the inhaler stored on the second computer readable storage medium. The system of claim 13.

17. The second computer-readable storage medium, comprising: sending a request to the inhaler; receiving second inhalation data from the inhaler; and transmitting the second puff data and an associated timestamp to the server; The first computer-readable storage medium may be configured to cause the processor of the first mobile device to: sending a request to the server including an indication of the last synchronization time between the first computer readable storage medium and the inhaler; and receiving from the server the second puff data and the associated timestamp of the inhaler, the timestamp associated with the second puff data being later than the last synchronization time between the first computer-readable storage medium and the inhaler. The system of claim 13.

18. The electronic module of the inhaler: initiating a counter in response to the electronic module being initially changed from an off state to an active state; recording the inhalation data in response to use of the inhaler by a user; Associating a counter value with the inhalation data; and configured to transmit the inhalation data and the counter value to the first mobile device; The first computer-readable storage medium is configured to cause the processor of the first mobile device to determine the timestamp using the counter value, the timestamp indicating a local average time of the inhalation data based on a time zone of the first mobile device. The system of claim 13.

19. The inhaler configured to administer multiple discrete doses of medicament; The drug is Albuterol sulfate (117 micrograms (mcg) of albuterol sulfate per discrete dose); Fluticasone propionate (55mcg, 113mcg or 232mcg of fluticasone propionate per discrete dose), or fluticasone propionate and salmeterol xinafoate combinations (55mcg, 113mcg or 232mcg of fluticasone propionate and 14mcg of salmeterol xinafoate per discrete dose), The system of claim 13.

20. The pharmaceutical agent comprises one of albuterol sulfate, fluticasone propionate or furoate, beclomethasone dipropionate, or a combination of fluticasone propionate or furoate and salometerol. The system of claim 13.

21. The inhaler further comprises a quick response (QR) code; the first mobile device further comprises a camera; The first computer-readable storage medium may be configured to cause the processor of the first mobile device to: receiving an image of the QR code of the inhaler using the camera of the first mobile device; determining a product identifier (ID) for the inhaler based on the image of the QR code; determining a dosing schedule for the inhaler using the product ID; and generating an alert indicating an upcoming scheduled dose based on the dose schedule of the inhaler. The system of claim 13.

22. 1. A system comprising: a server having a processor, a memory, and a communication circuit; an electronic module configured to be attached to and detached from the inhaler, the electronic module comprising a processor, memory, and communication circuitry; The system further comprises: a first computer readable storage medium present on a first mobile device; The first computer readable storage medium comprises: The computer-executable instructions, when executed by a processor of the first mobile device, cause the processor of the first mobile device to: sending a request for usage data to said electronic module; receiving the usage data from the electronic module, the usage data being associated with a timestamp; and transmitting the usage data and a timestamp to the server; The system further comprises: a second computer readable storage medium present on a second mobile device; The second computer readable storage medium comprises: The computer-executable instructions, when executed by a processor of the second mobile device, cause the processor of the second mobile device to: sending a request for the usage data of the electronic module to the server in response to detecting a login event to the second computer readable storage medium and prior to causing the second mobile device to send the request for the usage data to the electronic module; and receiving the usage data for the inhaler from the server in response to the request. A system characterized by:

23. The second computer-readable storage medium, comprising: and transmitting to the server a product identifier (ID) associated with the electronic module or a patient ID associated with a patient of the electronic module before the second computer-readable storage medium receives from the server the usage data of the electronic module.

23. The system of claim 22.

24. The second computer-readable storage medium, comprising: and periodically sending to the server a request comprising a timestamp of the most recent usage data of the electronic module stored on the second mobile device.

23. The system of claim 22.

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