Drug delivery device with electronics and power management

Abstract

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

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of Provisional U.S. Patent Application No. 62 / 870,894, filed on July 5, 2019, the disclosure of which is incorporated herein by reference in its entirety. Background Art

[0003] Drug delivery devices help deliver drugs to patients via various routes of administration. Typical routes of administration include oral, topical, sublingual inhalation, injection, and the like. Devices can be used to deliver drugs for treating various diseases, ailments, and medical conditions. Inhalation devices can be used, for example, to treat asthma, chronic obstructive pulmonary disease (COPD), and cystic fibrosis (CF). Although drug delivery devices can be designed to deliver appropriate doses of drugs to patients as part of therapeutic treatment, the effectiveness of treatment may be affected by non-physiological factors, such as the patient's compliance and compliance when using the device.

[0004] Drug delivery devices may be equipped with sensors to track adherence and compliance. For example, a device may include sensors for detecting when the device is actuated to deliver a dose of medication and / or its orientation during actuation. This information may be stored in local memory and subsequently communicated to another device (e.g., a smartphone, tablet, or computer) for further processing. The device's actuation history may be compared to the dosing regimen prescribed by a physician to determine the patient's compliance level. Other sensor data, such as the orientation of the device during operation, may be reviewed to determine whether the patient is using the device in a compliant manner that facilitates proper delivery of the medication.

[0005] 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 feasible power sources for the device. Therefore, when selecting a power source for a drug delivery device having an electrical component, a limited amount of power may be available. Summary of the invention

[0006] A system may be configured to limit the number of times an inhalation device (e.g., an inhaler) transmits inhalation data to a single instance, for example, to help reduce battery usage of the inhalation device. The system may include one or more inhalation devices. The inhalation device may include a mouthpiece, a medicament, and an electronic module. The medicament may include albuterol (e.g., albuterol sulfate, for example, at a concentration of 117mcg), fluticasone (e.g., fluticasone propionate, for example, 55mcg, 113mcg, or 232mcg fluticasone propionate per dose delivered by the inhalation device), beclomethasone dipropionate, or fluticasone (e.g., fluticasone propionate, for example, 55mcg, 113mcg, or 232mcg fluticasone propionate per dose delivered by the inhalation device) in combination with salmeterol (e.g., salmeterol xinafoate, for example, 14mcg salmeterol xinafoate per dose delivered by the inhalation device). The electronic module may include any combination of a controller (e.g., a processor), communication circuitry (e.g., a transmitter, a receiver, a transceiver, etc.), one or more sensors (e.g., a pressure sensor, a temperature sensor, a humidity sensor, an orientation sensor, etc.), a power supply, and / or a 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 computer, a mobile device, etc.).

[0007] The system may also include multiple mobile devices, wherein each mobile device may include communication circuitry, memory, and a mobile application for the inhalation device (e.g., a mobile application specific to the inhalation device). The mobile devices (e.g., and corresponding mobile applications) may be controlled, for example, by different family members or health care providers, for example, to ensure that the user of the inhalation device adheres to and complies with their medication regimen.

[0008] In some examples, a first mobile application residing on a first mobile device may be configured so that the first mobile device transmits a request for inhalation data to the inhalation device, receives inhalation data from the inhalation device (e.g., which may include a timestamp or counter value determined by the inhalation device), and transmits the inhalation data to a cloud-based system. In some examples, the request for inhalation data may include an indication of the most recent inhalation data of the inhalation device stored on the first mobile device. Therefore, the inhalation data received from the inhalation device in response to the request by the first mobile application in response to the request may appear before (e.g., postpone) the indication (e.g., request) sent to the inhalation device. For example, the inhalation data may have appeared after (following any inhalation data) any inhalation data that may have been stored on the first mobile device. For example, the indication may include the timestamp of the most recent inhalation data of the inhalation device stored on the first mobile device, and the inhalation data sent in response to the request may be the inhalation data that postpones the timestamp of the most recent inhalation data (e.g., the only inhalation data that postpones the timestamp).

[0009] The second mobile application residing on different mobile devices can be configured to make the second mobile device transmit the request to the cloud-based system, and be configured to receive the inhalation data of the inhalation device from the cloud-based system in response to the request. The second mobile application can be configured to transmit the request to the cloud-based system before the second mobile device transmits the request to the inhalation data to the inhalation device, thereby ensuring that the battery use of the inhalation device is reduced. In some instances, the request can include the indication of the last synchronization time between the second mobile application and the inhaler. Thus, the cloud-based system can be configured to send the inhalation data after the last synchronization time between the second mobile application and the inhaler. In some instances, the second mobile application is configured to make the second mobile device transmit the request to the cloud-based system in response to detecting the user login event to the second mobile application, and this is before the second mobile device transmits the request to the inhalation data to the inhalation device.

[0010] In some embodiments, the first and second mobile applications (e.g., associated with the inhalation device) may be authenticated by the cloud-based system prior to receiving inhalation data from the inhalation device and / or prior to transmitting the inhalation data to or receiving the inhalation data from the cloud-based system. For example, the second mobile application may be configured such that the second mobile device transmits a product identification (ID) associated with the inhalation device or a patient ID associated with a patient of the inhalation device to the cloud-based system prior to the second mobile application receiving the inhalation data of the inhalation device from the cloud-based system. The mobile application may receive the product ID via a quick response (QR) code located on the inhalation device.

[0011] 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., mobile application / mobile device is associated with the inhalation device), and is configured to confirm that the inhalation device is properly marked (e.g., confirming that the medicine marked on the inhalation device is correct). The inhalation device may include medicament, electronic module and QR code. The mobile application may reside on a mobile device including a camera. The mobile application may be configured to use QR code to determine the information related to the inhalation device (e.g., the medicine type and / or dosage number of the inhalation device). For example, the mobile application may be configured to access the camera to receive the information related to the QR code, determine the product identifier (ID) of the inhalation device based on the QR code, and determine the information related to at least one of the medicine type or dosage number of the inhalation device based on the product ID. For example, the product ID may be a multi-character code for directly indicating the type of medicine in the inhalation device, the strength of the medicine and / or the dosage number. Alternatively or in addition, the mobile application may send the product ID to a cloud-based system, and the cloud-based system may send the information related to the inhalation device to the mobile application.

[0012] The mobile application can 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 can be configured to determine the timing of the dosing schedule and / or dosing reminders for the inhalation device directly based on the QR code (e.g., via the product ID). Alternatively or in addition, the mobile application can receive the timing of the dosing schedule and / or dosing reminders from a cloud-based system using the product ID. The mobile application can be configured to provide one or more dosing reminders based on the dosing schedule.

[0013] In the example that the inhalation device includes a QR code, the inhalation device does not include an actuator, a button or a switch to initiate a communication pairing process with a mobile device. Specifically, the mobile application is configured to use the QR code to pair the mobile device (e.g., the communication module of the mobile device) to the inhalation device (e.g., the communication module of the inhalation device). For example, the mobile application can be configured to determine a communication key unique to the inhalation device based on the QR code, and to enable the mobile device to transmit the communication key to the electronic module of the inhalation device to achieve communication between the electronic module and the mobile application. The communication key can include a product ID. The communication key can, for example, include a Bluetooth Low Energy (BLE) key.

[0014] The mobile application can be configured to determine that the inhalation device is not compatible with the mobile application based on the drug type of the inhalation device, and display an error message based on the inhalation device being not compatible with the mobile application. In addition, the mobile application can be configured to reject the pairing process of the inhalation device with the mobile device based on the inhalation device being not compatible with the mobile application. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Figure 1 is a front perspective view of an example inhalation device.

[0016] Figure 2 is a cross-sectional interior perspective view of an example inhalation device.

[0017] Figure 3 An exploded perspective view of the inhalation device with the top cover removed to expose the electronic module.

[0018] Figure 4 An exploded perspective view of the top cover and electronic module of the inhalation device.

[0019] Figure 5 is a diagram of an example system including an inhalation device.

[0020] Figure 6 is a graph of example airflow rate versus pressure. DETAILED DESCRIPTION

[0021] The present disclosure describes devices, systems and methods for sensing, tracking and / or processing 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 a drug 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.

[0022] Asthma and COPD are chronic inflammatory diseases of the respiratory tract. Both are characterized by variable and recurring symptoms of airflow obstruction and bronchospasm. Symptoms include episodes of wheezing, coughing, chest tightness, and shortness of breath. Symptoms are controlled by avoiding triggers and by using medications, particularly inhaled medications. Medications include inhaled corticosteroids (ICS) and bronchodilators.

[0023] Inhaled corticosteroids (ICS) are steroid hormones used for long-term control of respiratory conditions. They work by reducing airway inflammation. Examples include budesonide, (dipropionic acid / dipropionic acid HFA) beclomethasone, (propionic acid) fluticasone, (furoic acid) mometasone, ciclesonide, and dexamethasone (sodium). Parentheses indicate example (e.g., preferred) salt or ester forms.

[0024] Different types of bronchodilators target different receptors in the respiratory tract. Two commonly used categories are β2-agonists and anticholinergics. β2-adrenergic agonists (or "β2-agonists") act on the β2-adrenergic receptors that induce smooth muscle relaxation, thereby dilating the bronchial passages. It is often classified by the duration of action. Examples of long-acting β2-agonists (LABAs) include (fumaric acid) formoterol, (ximetoic acid) salmeterol, (maleic acid) indacaterol, (hydrochloric acid) bambuterol, (hydrochloric acid) clenbuterol, (hydrochloric acid) olodaterol, (hydrochloric acid) carmoterol, (hydrochloric acid) tulobuterol and (triphenylacetic acid) vilanterol. Examples of short-acting β2-agonists (SABAs) are salbutamol (sulfate) and terbutaline (sulfate).

[0025] Typically, short-acting bronchodilators provide rapid relief of acute bronchoconstriction (and are often referred to as "first aid" or "relief" medicines), while long-acting bronchodilators help control and prevent long-term symptoms. However, some fast-acting long-acting bronchodilators can be used as first aid medicines, such as (fumarate) formoterol. Therefore, first aid medicines provide relief of acute bronchoconstriction. Take first aid medicines as needed / when necessary (pro re nata). First aid medicines can also be in the form of combination products, such as ICS-(fumarate) formoterol, typically budesonide-(fumarate) formoterol or (dipropionate) beclomethasone-(fumarate) formoterol. Therefore, first aid medicines are preferably SABA or fast-acting LABA, more preferably (sulfuric acid) salbutamol or (fumaric acid) formoterol, and most preferably (sulfuric acid) salbutamol.

[0026] Anticholinergics (or "antimuscarinics") block the neurotransmitter acetylcholine by selectively blocking its receptors in nerve cells. When applied topically, anticholinergics act primarily on M3 muscarinic receptors located in the respiratory tract to produce smooth muscle relaxation, thereby producing a bronchodilatory effect. Examples of long-acting muscarinic antagonists (LAMAs) include tiotropium (bromide), oxitropium (bromide), aclidinium (bromide), umeclidinium (bromide), ipratropium (bromide), glycopyrronium (bromide), oxybutynin (hydrochloride or hydrobromide), tolterodine (tartrate), trospium (chloride), solifenacin (succinate), fesoterodine (fumarate), and darifenacin (hydrobromide).

[0027] Several approaches have been taken in preparing and formulating these medicaments for delivery by inhalation, for example via a dry powder inhaler (DPI), a pressurized metered dose inhaler (pMDI), or a nebulizer.

[0028] According to the Global Initiative for Asthma (GINA) guidelines, a stepwise approach can be taken to treat asthma. At step 1, which represents a mild form of asthma, the patient is provided with the required SABA, such as salbutamol sulfate. The patient may also be provided with the required low-dose ICS-formoterol, or a low-dose ICS may be provided whenever a SABA is taken. At step 2, a conventional low-dose ICS is provided together with the SABA, or a required low-dose ICS-formoterol. At step 3, a LABA is added. At step 4, the dose is increased, and at step 5, further additional treatments are included, such as anticholinergics or low-dose oral corticosteroids. Therefore, the corresponding steps can be considered as a treatment regimen, which is configured according to the acute severity of the respiratory disease.

[0029] 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. Patients with COPD experience pathological changes that are primarily localized to the airways, lung parenchyma, and pulmonary vasculature. Phenotypically, these changes reduce the healthy ability of the lungs to absorb and expel gases.

[0030] Bronchitis is characterized by long-term inflammation of the bronchi. Common symptoms may include wheezing, shortness of breath, coughing and expectoration, all of which are highly uncomfortable and impair the patient's quality of life. Emphysema is also associated with long-term bronchial inflammation, in which the inflammatory response leads to rupture of lung tissue and progressive narrowing of the airways. Over time, the lung tissue loses its natural elasticity and becomes enlarged. As a result, the effectiveness of gas exchange decreases, and the breathed air is often trapped in the lungs. This leads to local hypoxia and reduces the amount of oxygen delivered to the patient's bloodstream at each inhalation. As a result, patients experience shortness of breath and difficulty breathing.

[0031] Patients with COPD experience various, if not all, of these symptoms every day. The severity of these symptoms will be determined by a range of factors, but the most common is related to the progression of the disease. These symptoms, regardless of their severity, represent stable COPD, and this disease condition is maintained and controlled by the administration of various medications. Treatment is variable, but typically includes inhaled bronchodilators, anticholinergics, long-acting and short-acting β2-agonists, and corticosteroids. Medications are often administered as monotherapy or as a combination therapy.

[0032] Patients were classified according to the severity of their COPD using the categories defined in the GOLD guidelines (Global Initiative for Chronic Obstructive Lung Disease, Inc.). The categories were labeled A to D, and the recommended first-choice treatment varied by category. Patient group A was recommended to use a short-acting muscarinic antagonist (SAMA) when necessary or a short-acting beta2-agonist (SABA) when necessary. Patient group B was recommended to use a long-acting muscarinic antagonist (LAMA) or a long-acting beta2-agonist (LABA). Patient group C was recommended to use an inhaled corticosteroid (ICS) + LABA or LAMA. Patient group D was recommended to use ICS + LABA and / or LAMA.

[0033] Patients with respiratory diseases such as asthma or COPD suffer periodic exacerbations that exceed the baseline daily variation in their condition. An exacerbation is an acute increase in respiratory symptoms that requires additional therapy (ie, therapy beyond their maintenance therapy).

[0034] For asthma, additional therapy for moderate exacerbations is repeated doses of SABA, oral corticosteroids, and / or controlled-flow oxygen (the latter of which requires hospitalization). For severe exacerbations, an anticholinergic (usually ipratropium), nebulized SABA, or IV magnesium sulfate is added.

[0035] For COPD, additional therapy for moderate exacerbations is repeated dosing of SABA, oral corticosteroids, and / or antibiotics. In severe exacerbations, controlled-flow oxygen and / or respiratory support (both of which require hospitalization) are added. Within the meaning of the present disclosure, exacerbations encompass both moderate and severe exacerbations.

[0036] Figure 1 1 is a front perspective view of an example inhalation device 100. The example inhalation device 100 may be a breath-actuated inhalation device. The inhalation device 100 may include a top cover 102, a main housing 104, a mouthpiece 106, a mouthpiece cover 108, a medicament, and a vent 125. The top cover 102 may be mechanically attached to the main housing 104. The mouthpiece cover 108 may be hinged to the main housing 104 so that the mouthpiece cover 108 may be opened and closed to expose the mouthpiece 106. Although illustrated as a hinged connection, the mouthpiece cover 108 may be connected to the inhalation device 100 by other types of connections.

[0037] Inhalation device 100 may include a rescue agent or a maintenance agent. The rescue agent may be a SABA or a fast-acting LABA, such as (fumaric acid) formoterol. The rescue agent may also be in the form of a combination product, such as ICS-(fumaric acid) formoterol, typically budesonide-(fumaric acid) formoterol or (dipropionic acid) beclomethasone-(fumaric acid) formoterol. This method is called "MART" (maintenance and rescue therapy). In some instances, the agent is (sulfuric acid) salbutamol, (propionic acid or furoic acid) fluticasone, or (ximetocil) salmeterol combined with (propionic acid or furoic acid) fluticasone.

[0038] Figure 2 1 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 dosing cup 116, a dosing chamber 117, a deagglomerator 121, and a flow path 119. The drug reservoir 110 may contain a drug, such as a dry powder medicament, 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 so that movement of the mouthpiece cover 108 may cause movement of the yoke 118. For example, when the mouthpiece cover 108 moves to expose the mouthpiece 106 (eg, from a closed position to an open position), the yoke 118 may move vertically within the inhalation device 100 (eg, toward or away from the top cover 102).

[0039] The movement of the yoke 118 may cause the bellows 112 to compress, thereby delivering a dose of the drug from the drug reservoir 110 to the dosing cup 116. Thereafter, the user may inhale through the mouthpiece 106 to receive the dose of the drug. The airflow generated by the user's inhalation may cause the deagglomerator 121 to atomize the dose of the drug by breaking down the agglomerates of the medicament in the dosing cup 116. The deagglomerator 121 may be configured to atomize the drug when the airflow through the flow path 119 reaches or exceeds a rate or is within a specific range. When atomized, the dose of the drug may enter the dosing chamber 117 from the dosing cup 116, pass through the flow path 119 and exit the mouthpiece 106 to the user. If the airflow through the flow path 119 does not reach or exceed a rate or is not within a specific range, all or a portion of the drug may remain in the dosing cup 116. In the event that the drug in the dosing cup 116 has not been aerosolized by the deagglomerator 121, another dose of the drug may not be delivered from the drug reservoir 110 when the mouthpiece cover 108 is subsequently opened. Thus, at least a portion of a dose of the drug may remain in the dosing cup 116 until the dose has been aerosolized by the deagglomerator 121.

[0040] When the user inhales through the mouthpiece 106, air can enter the vents 125 to provide an air flow for delivering the drug to the user. The flow path 119 can extend from the dosing chamber 117 to the end of the mouthpiece 106. The flow path can include the dosing chamber 117 and the interior portion of the mouthpiece 106. The dosing cup 116 can reside within or adjacent to the dosing chamber 117.

[0041] Although illustrated as a combination of bellows 112, bellows spring 114, yoke 118, dosing cup 116, dosing chamber 117, and deagglomerator 121, the dose delivery mechanism may include a subset of the components described and / or the inhalation device 100 may include a different dose delivery mechanism (e.g., based on the type of inhalation device, the type of medication, etc.). For example, in some instances, the medication 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 medication, and make the dose of medication available to the dosing chamber and / or mouthpiece for inhalation by a user.

[0042] exist Figure 1In the illustrated example dose delivery mechanism of the present invention, the dose counter 111 may be mechanically coupled (e.g., directly or indirectly) to the mouthpiece cover 108 so that the dose counter 111 may be incremented or decremented 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 decrease by one each time the mouthpiece cover 108 is moved from the closed position to the open position (or from the open position to the closed position), thereby indicating the number of remaining doses available. Alternatively, the dose counter 111 may be initially set to zero and may be configured to increase by one each time the mouthpiece cover 108 is moved from the closed position to the open position (or from the open position to the closed position), thereby indicating the total number of doses delivered from the drug reservoir 110.

[0043] The inhalation device 100 may include an electronic module 120, which may be housed within the top cover 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 associated with 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 computer, or computer, for further processing.

[0044] Figure 3 102 is removed to expose the exploded perspective view of the example inhalation device 100 of the electronic module 120. The top cover 102 can accommodate the electronic module 120, and the electronic module 120 can include a printed circuit board (PCB) assembly 122. The PCB assembly 122 can include one or more components, such as a sensor system 128 and a wireless communication circuit 129. The top cover 102 can be attached to the main housing 104 via one or more fixing clips (not shown) that engage the groove on the main housing 104. When connected, the top cover 102 can overlap with a part of the main housing 104, for example, so that there is a substantially pneumatic seal between the top cover 102 and the main housing 104. The top surface of the main housing 104 can include one or more (for example, two) orifices 146. One of the orifices 146 can be configured to receive a slide 140. For example, when the top cover 102 is attached to the main housing 104, the slide 140 can protrude through the top surface of the main housing 104 via one of the orifices 146. The top cover 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 cover 102 housing the electronic module 120 may be permanently attached to the main housing 104.

[0045] In addition, in some examples, the electronic module 120 may reside in a separate device that is located outside the inhalation device 100 and separated from the inhalation device 100. For example, the electronic module 120 may reside in an additional device that is configured to be attached to the inhalation device 100 and subsequently (e.g., when the inhalation device 100 runs out of medicine or expires) removed from the inhalation device 100. In this case, whenever a user receives a new inhalation device 100, the user can attach the additional device that includes the electronic module 120 from one inhalation device 100 to another inhalation device. The additional 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 medicine tank (e.g., so that the sensor is in fluid communication with the mouthpiece and / or the flow channel of the inhalation device 100) of the main housing 104 of the inhalation device 100. Therefore, in some examples, the inhalation device 100 may be (e.g., completely or partially) replaced by an additional device that includes the electronic module 120 and (may be) replaced by an inhaler that does not include electronic parts.

[0046] Figure 4 FIG. 1 is an exploded perspective view of the top cover 102 and the electronic module 120. Figure 4 , the slider 140 may define an arm 142, a stop 144, and a distal base 145. The distal end 145 may be a bottom portion of the slider 140. The distal end 145 of the slider 140 may be configured to abut a yoke 118 residing within the main housing 104. The top cover 102 may include a slider guide 148 configured to receive a slider spring 146 and 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 cover 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 installed 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 cover 102. For example, the slider spring 146 may be configured such that the distal end 145 of the slider 140 remains in contact with the yoke 118 when the mouthpiece cover 108 is closed.

[0047] The distal end 145 of the slider 140 may also remain in contact with the yoke 118 when the mouthpiece cover 108 is opened or closed. The stop 144 of the slider 140 may engage a stop of the slider guide 148, for example, so that the slider 140 is maintained in the slider guide 148 through the opening and closing of the mouthpiece cover 108, and vice versa. The stop 144 and the slider guide 148 may be configured to limit the vertical (e.g., axial) travel of the slider 140. This limit may be less than the vertical travel of the yoke 118. Therefore, when the mouthpiece cover 108 is moved to the open position, the yoke 118 may continue to move in the vertical direction toward the mouthpiece 106, but the stop 144 may stop the vertical travel of the slider 140 so that the distal end 145 of the slider 140 may no longer be in contact with the yoke 118.

[0048] As described above, the electronic module 120 may include one or more components, such as a sensor system 128 and a wireless communication circuit 129. The electronic module 120 may further include a switch 130, a power supply 126 (e.g., a battery), a power supply socket 124, an indicator (e.g., a light emitting diode (LED)), a controller (e.g., a processor), and / or a memory. When used herein, the terms controller and processor are used interchangeably. One or more of the components of the electronic module 120 may be mounted on the PCB 122 and electrically coupled to the PCB 122. The controller and / or the memory may be physically distinct components of the PCB 122. Alternatively, the controller and the memory may be part of a chipset mounted on the PCB 122. For example, the wireless communication circuit 129 may include a controller and / or a memory for the electronic module 120. The controller of the 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 circuit. The memory may contain computer executable instructions that, when executed by the controller, cause the controller to implement the processes of the electronic module as described herein.

[0049] The controller can access information from the memory and store data in the memory. The memory can include any type of suitable memory, such as non-removable memory and / or removable memory. The non-removable memory can include random access memory (RAM), read-only memory (ROM), hard disk, or any other type of memory storage device. The removable memory can include a subscriber identity module (SIM) card, a memory stick, a secure digital (SD) memory card, and the like. The memory can be internal to the controller. The controller can also access data from a memory that is not physically located in the electronic module 120 (e.g., on a server or a smart phone) and store data in the memory.

[0050] The battery 126 can provide power to the components of the PCB 122. The battery 126 can be any suitable source, such as a button cell, for example, for powering the electronic module 120. The battery 126 can be rechargeable or non-rechargeable. The battery 126 can be accommodated by a battery holder 124. The battery holder 124 can be fastened to the PCB 122 so that the battery 126 remains in continuous contact with the PCB 122 and / or is electrically connected to the components of the PCB 122. The battery 126 can have a battery capacity that may affect the life of the battery 126. As will be further discussed below, the power distribution from the battery 126 to one or more components of the PCB 122 can be managed to ensure that the battery 126 can power the electronic module 120 during the service life of the inhalation device 100 and / or the medicine contained therein.

[0051] The switch 130 can be actuated by the dose delivery mechanism of the inhalation device 100. When the example dose delivery mechanism described herein is incorporated, the switch 130 can be actuated by the slide 140 when the mouthpiece cover 108 moves from the closed position to the open position. But it should be understood that if the inhalation device 100 includes different dose delivery mechanisms, the switch 130 can be actuated by different components of the dose delivery mechanism. When the switch 130 is actuated, the electronic module 120 can generate a signal that makes the electronic module 120 change the state, for example, from a closed or dormant state to an activated state. When in the activated state, the controller of the electronic module 120 can wake up and provide power to the sensor system 128 so that the sensor system 128 can obtain measurement readings. In addition, the electronic module 120 can store a dosing event (for example, it can be referred to as a dose delivery event or an actuation event) whenever the switch 130 is actuated. As described in more detail below, the electronic module 120 can have a plurality of power states, and each power state has a corresponding power consumption level. For example, the electronic module 120 may be configured to operate in a system off state, a dormant state, and / or an active state, wherein the electronic module 120 consumes a minimal amount of power when in the off state (e.g., no power or just enough to run a clock), the dormant state uses more power than the off state (e.g., to drive memory, communication circuits, and / or timers or clocks), and the active state uses the greatest amount of power (e.g., to drive a controller, one or more sensors, communication circuits, and / or timers or clocks, potentially in a faster notification mode than the dormant state).

[0052] 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 sensor may include an air pressure sensor (e.g., an atmospheric pressure sensor), a differential pressure sensor, an absolute pressure sensor, and / or the like. The sensor may employ microelectromechanical systems (MEMS) and / or nanoelectromechanical systems (NEMS) technology. The pressure sensor may be configured to detect and / or measure the pressure change within the inhalation device 100 caused by inhalation from the mouthpiece 106 (or exhalation into the mouthpiece 106). One or more of the measured pressure changes may be used to determine the amount of airflow (e.g., airflow rate) of the flow path 119 through 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 atomize a dose of medicine when the airflow rate exceeds a threshold, then the use may be considered as compliance when the determined airflow rate is higher than the threshold. On the contrary, the use may be considered as non-compliance when the determined airflow is lower than the threshold.

[0053] The electronic module 120 (e.g., and / or a mobile application resident on an external device) can determine one or more drug administration events using the measurements from the sensor system 128. For example, the electronic module 120 can be configured to compare one or more measurements from the sensor system 128 with one or more thresholds to classify an inhalation event as a no / low inhalation event, a normal inhalation event, a good inhalation event, an excessive inhalation event, and / or an exhalation event. For example, the electronic module can generate a good inhalation event when the measurements from the sensor system 128 indicate a flow rate within a specific range (e.g., between 200 liters per minute (L / min) and 45 L / min), generate a normal inhalation event when the measurements from the sensor system 128 indicate a flow rate within another range (e.g., 30 L / min and 45 L / min), generate a no inhalation event when the measurements from the sensor system 128 indicate a flow rate less than a threshold value (e.g., 30 L / min), and generate an excessive inhalation event when the measurements from the sensor system 128 indicate a flow rate greater than an upper threshold value (e.g., greater than 200 L / min).

[0054] The temperature sensor may include a thermistor, a thermocouple, a resistance temperature detector, a temperature sensor chip and the like. The temperature sensor may be configured to provide a temperature reading to the controller of the electronic module 120 and / or provide a temperature reading gathered over time. The temperature sensor may be configured to measure the external temperature in the space close to the suction device 100. Therefore, the main housing 104 and / or the top cover 102 may include an opening (for example, a vent) to allow the temperature sensor to measure the ambient temperature outside the housing.

[0055] Alternatively or in addition, the temperature sensor may be configured to measure a temperature within the inhalation device 100, e.g., a temperature within one or more of the top cover 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 allow the electronic module 120 to determine the operating temperature of the components of the electronic module 120, the temperature of the air flowing through the inhalation device 100 when the user inhales through the inhalation device 100, etc. Thus, the electronic module 120 may be configured to detect an over-temperature or under-temperature condition, such as an over-temperature condition of one or more of the 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 exceeding a threshold, etc. The electronic module 120 may be configured such that the communication circuit 129 transmits a temperature message indicating an over-temperature condition, an ambient temperature reading, and / or a temperature reading inside the inhalation device 100 (e.g., a temperature change detected through a flow channel of the inhalation device 100) to an external device (e.g., a mobile device).

[0056] In addition, in some instances, the pressure sensor may include a temperature sensor. The humidity sensor may include a capacitive sensor, a resistive sensor, a thermal conductivity sensor and the like. The humidity sensor may be configured to provide a humidity reading to the controller of the electronic module 120 and / or provide a humidity reading that is gathered over time. The temperature and / or humidity measurements may be used to identify and track the environmental conditions of the use or storage of the inhalation device 100. The temperature and / or humidity measurements may be used to determine whether the device 100 is operating or storing in an environment that may impair the proper operation of the device 100 and / or the efficacy of the drug in the drug reservoir 110. For example, extreme hot or cold temperatures or excessive humidity levels may contribute to device failure and / or change the properties of the drug in the reservoir 110.

[0057] The orientation sensor may include an accelerometer, a gravity (G) sensor, a gyroscope, a magnetometer, and the like. The orientation sensor may be configured to provide orientation readings (e.g., acceleration, rotation, direction, etc.) to a controller of the electronic module 120 and / or provide orientation readings aggregated over time. Data from the orientation sensor may be used to identify and track how a user handles or interacts with the device 100 when attempting to receive a dose of medication. The data may be used to determine whether the device 100 is operating in a compliant manner, such as during dose delivery. For example, the orientation sensor may indicate whether a user is holding the device 100 upside down during inhalation, which may prevent or hinder delivery of a complete dose of medication from the dosing cup 116 and / or dosing chamber 117.

[0058] As mentioned above, electronic module 120 may include one or more indicators, such as LED, which may be accommodated or positioned on device 100 so that the user may observe any feedback provided. The controller operable indicator in electronic module 120 may provide feedback to the user about its use of suction device 100 and / or the condition of using or storing suction device 100. If one or more measured values ​​from sensor system 128 are higher or lower than a predetermined threshold, controller may make the state of indicator change (such as, LED may be connected, flicker, change color etc.) so. For example, if measured pressure changes, determined airflow rate, measured temperature and / or measured humidity level exceed threshold, controller may make LED illuminate so. If the data indication from directional sensor does not properly hold device 100, controller may make LED illuminate so.

[0059] The data from sensor system 128 (e.g., pressure change, temperature, humidity level, etc.) and / or the parameters derived therefrom (e.g., airflow rate) can be communicated to an external device, such as a smart phone, a tablet computer, or a computer. More specifically, the wireless communication circuit 129 in the electronic module 120 can include a transmitter and / or a receiver (e.g., a transceiver) and an additional circuit system. For example, the wireless communication circuit 129 can include a Bluetooth chipset (e.g., a Bluetooth low power chipset), a ZigBee chipset, a Thread chipset, etc. Therefore, the electronic module 120 can provide data wirelessly to an external device for review and / or additional processing. The external device can include software for processing received information and for providing compliance and compliance feedback to the user of the inhalation device 100 via a graphical user interface (GUI).

[0060] The power supply 126 can provide power to the electrical components of the PCB 122. The power supply 126 can be any suitable source for powering the electronic module 120, such as a button battery, for example. The power supply 126 can be rechargeable or non-rechargeable. The power supply 126 can be received by the power supply holder 124. The power supply holder 124 can be fastened to the PCB 122 so that the power supply 126 remains in continuous contact with the PCB 122 and / or is electrically connected to the components of the PCB 122.

[0061] The selection of power supply 126 can be based on various factors, such as its size, weight, cost and / or power capacity. Make the selection of power supply 126 based on an attribute can adversely affect the operation or design of suction device 100 relative to other attributes of power supply 126.For example, the supplier with minimum physical size, minimum weight and / or minimum cost may have the capacity that is not enough to be powered for electronic module 120 in the required time period (such as, the normal operation life of device 100).On the contrary, the supplier with the capacity that is enough to be powered for electronic module 120 in the required time period may not be suitable for packing into the available space in the top cover 102 and / or may be more expensive.Therefore, the selection of power supply 126 can include one or more balances in its technology and / or business attributes.In addition, the operation of electronic module 120 can be configured to limit or manage the power consumption from power supply 126, which can realize the selection of the smaller, cheaper supplier that can be reliably powered for electronic module 120 in the required time period and under required operating conditions.

[0062] The electronic module 120 may have multiple power states, each power state having a corresponding power consumption level. For example, the electronic module 120 may be configured to operate in a system shutdown state, a sleep state, and / or an activated state. When the electronic module 120 is in an activated state, the electronic module 120 may operate in one or more modes (e.g., a measurement mode, a data storage / data processing mode, a notification mode, and / or a connection mode). It should be understood that the electronic module 120 may operate in multiple modes at once (e.g., the modes may overlap).

[0063] 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 take pressure measurement readings, temperature readings, humidity readings, orientation readings, etc. for a predetermined period of time (e.g., up to 60 seconds) and / or until the mouthpiece cover 108 is closed or no change in the measurement is detected. The controller may shut down one or more components of the electronic module 120 while the sensor system 128 captures the readings to further save power. The sensor system 128 may sample the readings at any suitable rate. For example, the sensor system 128 may have a sampling rate of 100 Hz and therefore a cycle time of 10 milliseconds. The sensor system 128 may generate a measurement complete interrupt after the measurement cycle is completed. The interrupt may wake up the controller or cause it 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 readings, humidity readings, orientation readings, etc., the controller may process and / or store the data and, if the measurement is complete, shut down the sensor system 128.

[0064] In data storage / data processing mode, the controller can be powered on at least a portion of the memory in the electronic module 120. The controller can process the reading from the sensor system 128 to calculate, estimate or otherwise determine (e.g., use and / or storage conditions) and store the parameters in the memory. The controller can also compare the reading and / or parameter with one or more threshold values ​​or scopes to assess the mode of using the suction device 100 and / or the condition of using the device 100. Depending on the result of the comparison, the controller can drive an indicator (e.g., LED) to provide feedback to the user of the suction device 100. As mentioned above, the electronic module 120 can operate under the measurement mode and data storage / data processing mode simultaneously.

[0065] In the connection mode, the communication circuit and memory can be powered on, and the electronic module 120 can be connected to or "paired" with an external device such as a smartphone. The controller can retrieve data (e.g., sensor data and / or parameters derived from the sensor data) from the memory and transmit the data wirelessly to the external device. The controller can retrieve and transmit all data currently stored in the memory. The controller can also retrieve and transmit a portion of the data currently stored in the memory. For example, the controller may be able to determine which portions have 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 that has been collected by the electronic module 120 after a specific time or after the last transmission to the external device. The controller can retrieve specific data (if any) from the memory and transmit the specific data to the external device.

[0066] Additionally, when connected to an external device, the electronic module 120 may be configured to transmit Bluetooth Special Interest Group (SIG) characteristics for managing access to data stored in the module 120. The Bluetooth SIG characteristics may include one or more of the following: a manufacturer's name of the inhalation device 100, a serial number of the inhalation device 100, a hardware revision number of the inhalation device 100, and / or a software revision number of the inhalation device 100. When connected to an external device, the electronic module 120 may retrieve data from the memory and transmit the data to the external device.

[0067] The data (for example, the signal produced by switch 130, the measurement reading obtained by sensor system 128 and / or the parameter calculated by the controller of electronic module 120) stored in the memory of electronic module 120 can be transmitted to an external device, which can process and / or analyze the data to determine the use parameters associated with inhalation device 100. Data can include any use parameters (for example, use events), which for example can include or indicate the use of corresponding inhalers. In relatively simple embodiments, at least one value can include "true" when the use of corresponding inhalers has been determined (for example, using corresponding inhalers to inhale), or "false" when determining that there is no such use of corresponding inhalers. However, use parameters can include any combination of events described herein, for example, no inhalation event, low inhalation event, good inhalation event, excessive inhalation event, exhalation event, actuation event, error event, insufficient use event, excessive use event, etc. Additionally, the usage parameters may include a count of the number of uses of the inhalation device 100, a measurement of the airflow of the inhalation device 100, other measurements indicative of usage of the medicament of the inhalation device 100, such as actuation of a switch configured to detect use of the inhalation device 100 (e.g., a switch actuated when a mouthpiece cover is moved from a closed position to an open position and / or when the inhaler is activated so as to move and / or open a blister of medicament included 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 depressed when the inhalation device 100 is in use.

[0068] In addition, it should be appreciated that the electronic module (e.g., processor) 120 is configured to time stamp the data (e.g., associate the time stamp with the data). For example, the electronic module 120 may include a local average clock, and a time stamp indicating the local average time of the inhalation device 100 may be associated with the data determined by the inhalation device 100. In other examples, the electronic module 120 may operate as an internal counter. When operating as an internal counter, the electronic module 120 determines a relative count (e.g., contrary to providing an average solar time, such as a local average time), and associates the relative count with the determined data. For example, when, for example, the electronic module 120 wakes up from an energy-saving sleep mode for the first time (e.g., after opening the mouthpiece cover for the first time), the electronic module 120 may start an internal counter (e.g., which counts infinitely from 0). Thereafter, any time stamp 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).

[0069] Additionally, the software application resident on the external device may generate feedback for the user based on data received from the electronic module 120. For example, the software application may generate daily, weekly, or monthly reports, provide confirmation of error events or notifications, provide instructional feedback to the user, and / or the like.

[0070] Figure 5 5 is a diagram of an example system 500 that includes an inhalation device 100, mobile devices 502, 504, 506, a public and / or private network 508 (e.g., the Internet, a cloud network, and / or any combination of the like), and a computer (e.g., a server) 512 associated with a health care provider (e.g., 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 that resides on one or more servers and may include computer software configured to perform the functions described with respect to the DHP 510.

[0071] Mobile devices 502, 504, 506 may include smartphones (e.g., Smartphone, Android Smartphone or Blackberry smartphones), personal computers, portable computers, wireless media devices (e.g., MP3 players, gaming devices, televisions, media streaming devices (e.g., Amazon Fire TV, Nexus players, etc.), tablet devices (e.g., handheld computing devices), televisions with Wi-Fi or wireless communication capabilities, wearable devices (e.g., Apple Watch ), or any other suitable device supporting Internet protocol.Mobile device 502,504,506 may include a processor, a memory, a communication circuit (e.g., a transceiver), a loud speaker, a microphone and / or a display screen.Mobile device 502,504,506 may have a mobile application stored thereon, and the mobile application is configured to enable the mobile device to perform functions described herein, such as communicating with one or more inhalation devices 100 and / or DHP 510, receiving, processing and / or gathering data received from an inhaler, generating new data and / or alarms based on the data received from the inhaler, and / or generating feedback (e.g., alarms) based on inhaler data, such as notifications, GUIs or audio feedback.

[0072] Also provided is a computer program including computer program code, which, when the computer program is run on a computer, is suitable for implementing any of the methods and techniques described herein. In a preferred embodiment, the computer program is at least partially in the form of a mobile application, such as a mobile application resident on a mobile device. And in some instances, the computer program is provided partially as a mobile application and partially as a DHP 510. The embodiments described herein for system 500 are applicable to the method and computer program. In addition, the embodiments described for the method and computer program are applicable to system 500.

[0073] Although described as a mobile device, in some examples, the system 500 may include a stationary device or a combination of a mobile device and a stationary device. The stationary device includes a smart home interface device, such as a smart speaker, a smart display, a smart home automation device, and / or the like. The stationary device includes hardware and / or software similar to the mobile device described herein (e.g., a processor, memory, communication circuitry (e.g., a transceiver), a speaker, a microphone, and / or a display screen), and is therefore configured to perform the functions described herein with respect to the mobile device.

[0074] 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 a public and / or private network 508, which may communicate with the DHP 510 and / or with a computer associated with a health care provider 512. For example, the mobile devices 502, 504, 506 may include communication circuitry (e.g., a transceiver) and, therefore, may be configured to communicate via a Wi-Fi communication link, a Wi-MAX communication link, The mobile devices 502, 504, 506 may transmit and / or receive RF signals via a Bluetooth Smart communication link, a Near Field Communication (NFC) link, a cellular communication link, a TV White Space Band (TVWS) communication link, or any combination thereof. The mobile devices 502, 504, 506 may communicate data to the DHP 510 via a public and / or private network 508 using, for example, a dedicated API. For example, the mobile devices 502, 504, 506 may send usage data associated with one or more inhalation devices 100 to the DHP 510.

[0075] As described above, the inhalation device 100 may include a communication circuit 129 (e.g., a Bluetooth radio) for transmitting data to an external device (e.g., one or more of the mobile devices 502, 504, 506). The 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 a signal generated by the switch 130, a measurement reading taken by the sensor system 128, and / or a parameter calculated by a controller of the electronic module 120. The data may include any combination of no inhalation events, low inhalation events, good inhalation events, excessive inhalation events, exhalation events, actuation events, error events, underuse events, overuse events, etc. The data may include a count of the number of uses of the inhalation device 100, a measurement of the airflow of the inhalation device 100, other measurements indicative of the use of the medicament of the inhalation device 100, such as actuation of a switch configured to detect use of the inhalation device 100 (e.g., a switch actuated when a mouthpiece cover is moved from a closed position to an open position and / or when the inhaler is activated in order to move and / or open a blister of medicament included 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 when using the inhalation device 100. The data may be associated with a timestamp, for example, as described herein.

[0076] Inhalation device 100 can receive data from mobile device 502,504,506, such as program instruction, operating system change, administration information, alarm or notification, confirmation etc.In addition, although described as single inhalation device 100, system 500 can include any number of inhalation devices 100 associated with a plurality of different users.It should be noted that some users will have a plurality of inhalation devices 100 comprising the same medicament.For example, the user can have a plurality of inhalation devices 100 comprising first aid medicament (for example, and it is maintained at different positions).In addition, the user can have a plurality of inhalation devices 100 comprising specific maintenance medicament, such as when described a plurality of inhalation devices 100 when switching between refilling.In addition, system 500 can be configured with the inhalation device 100 of a plurality of different users.Therefore, system 500 is configured to communicate with a plurality of different inhalers associated with a plurality of different users via corresponding mobile device.

[0077] 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 inhalation events, low inhalation events, good inhalation events, excessive inhalation events, exhalation events, actuation events, error events, underuse events, overuse 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.

[0078] The mobile device 502, 504, 506 may be configured to receive data (e.g., use events) and associated time stamps (e.g., relative counts from the internal counter of the electronic module 120) from the inhalation device 100. The mobile device 502, 504, 506 may determine the local average time and time zone of the time stamp, and associate the local average time and time zone with the data (e.g., use events). The mobile device 502, 504, 506 may then send the data and the associated local average time and time zone to the DHP. The DHP may associate the data, the local average time, and the time zone with the user. Alternatively or in addition, the mobile device 502, 504, 506 may associate the data, the local average time, and the time zone with the user, and / or the DHP may determine the local average time based on the time stamp received from the inhalation device 100.

[0079] The DHP is configured to receive and aggregate inhaler data (e.g., use events) from inhalers associated with multiple different users. In some instances, the DHP may reside on one or more servers or reside across one or more servers, and may include computer software configured to perform the functions described relative to the DHP. For example, the DHP may include a dashboard application that can be accessed by a computer 512 associated with a health care provider (e.g., a hospital or hospital system, a health system, a medical group, a doctor, a clinic, and / or a pharmaceutical company). In some instances, the dashboard application is a web application (e.g., a web portal). For example, the DHP is also configured to provide data (e.g., inhaler data) to a clinician and a doctor by using a dashboard application (e.g., via a REST API).

[0080] DHP 510 is configured to receive and gather data from inhalation device 100, wherein inhaler can be associated with multiple different users.For example, DHP 510 is configured to receive and store inhaler data from mobile device 502,504,506 (for example, patient-oriented mobile application).Inhaler data can include any one of the data described with reference to inhaler described herein, such as use event, error event, inhalation profile, associated time stamp, type of medicament, etc.DHP 510 is configured to analyze and manipulate data.For example, DHP 510 can gather data across inhalation device (described DHP 510 receives data from described inhalation device), and then DHP 510 can analyze the data gathered, such as to determine one or more metrics, provide feedback, etc.In addition, DHP 510 is also configured to (for example, via mobile device 502,504,506) provide data (for example, or based on the analysis information of data) to user or (for example, via dashboard application) provide data to computer 512 associated with health care provider. The inhaler data may include any of the data described with reference to the inhalers described herein.

[0081] 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 at the DHP 510. One user profile may be associated with a plurality of inhalation devices 100 of the same and / or different medicament types. The DHP 510 may also de-identify (e.g., disassociate) the inhaler data with a specific user profile, and the DHP 510 may analyze the de-identified data associated with the inhalation device 100. Although described as receiving the inhaler data from the mobile device 502, 504, 506, in some instances, the DHP 510 may receive data directly from the inhalation device 100 itself, for example, in the case where the communication circuit of the inhalation device 100 includes a cellular chipset capable of communicating directly with the DHP 510.

[0082] Whenever data is transmitted from the inhalation device 100 to an external device (e.g., one or more of the mobile devices 502, 504, 506), the power supply 126 may provide power to one or more electrical components (e.g., the communication circuit 129) in the electronic module 120. Thus, the frequency of data transmission from the inhalation device 100 may affect overall power consumption and the ability of the power supply 126 to power the electronic module 120 within a desired time period. That is, more frequent data transmissions to the external device and / or data transmissions to multiple external devices may increase the power requirements of the electronic module 120 and reduce the functional life of the power supply 126. Therefore, the system 500 may be configured to limit the number of times that the inhalation device 100 transmits new data to the external device (e.g., limiting the transmission to a single data transmission). In addition, in some instances, 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 transmitted 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 devices associated with the user and the medicament within the system 500. In addition, in some examples, the mobile device (e.g., a mobile application resident on the external device) may check the system 500 (e.g., the DHP 510) before requesting data from the inhalation device 100, for example 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 connection mode, the mobile device may first request new data related to 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 recently updated data that the inhalation device 100 has transmitted before requesting new data from the inhalation device 100.

[0083] In one example, the inhalation device 100 may be provided to a child suffering from 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 devices 504, 506 may enable the child's parent to monitor conditions or parameters associated with their child's use of the inhalation device 100. The mobile application on the mobile device 502 may enable the child to do so. Therefore, data from the inhalation device 100 may need to be transmitted to three separate external devices.

[0084] If data is transmitted directly from the inhalation device 100 to the mobile devices 502, 504, 506, the power consumption associated with the wireless transmission may increase (e.g., increase three times) compared to when communicating with a single external device. This increase in power consumption may cause the functional life of the power supply 126 to be less than the expected life of the inhalation device 100 (e.g., less than the time during which a user expects to receive a dose of medicament from the inhalation device 100). Therefore, in order to extend the life of the power supply 126, one or more of the electronic module 120, the mobile application resident on the mobile device 504, and / or the DHP 510 may be configured to limit the number of times data can be transmitted from the electronic module 120 to the external device (e.g., to a single transmission of data from the inhalation device 100).

[0085] For example, see again Figure 5 , can prescribe medicine that can be applied via inhalation device 100 for children. The mother of the child can download the mobile application on her mobile device (e.g., mobile device 504). The mobile application can enable the mobile device 504 to be wirelessly connected to the inhalation device 100 and receive data collected by the electronic module 120. Such data can indicate when to deliver the dose from the device 100. The mobile application can also store the prescribed dosage regimen of the child. Thus, the mobile application can enable the mother of the child to monitor the time and frequency of her child's use of the inhalation device 100, and whether her child is complying with the dosage regimen. The child and the father of the child can similarly download the mobile application for their respective mobile devices 502, 506. However, in order to extend the life of the power supply 126 of the electronic module 120, the system 500 can be configured to limit the transmission of data from the electronic module 120 to a single transmission of data (e.g., data is only transmitted to one of the mobile devices 502, 504, 506).

[0086] For example, in some embodiments, when a mobile device (e.g., mobile device 504) is within the communication range of the electronic module 120 of the inhalation device 100, the mobile device 504 (e.g., having a mobile application resident thereon) may transmit a request for data from the inhalation device 100. The request may include an indication of the most recent data that the mobile device 504 has stored (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 timestamp that is more recent than the timestamp indicated by the request), the inhalation device 100 may transmit the more recent data to the mobile device 504. Thereafter, the mobile device 504 that receives the more recent data may upload the data to the DHP 510. Then, another of the mobile devices that does not directly receive the more recent data from the inhalation device 100 (e.g., such as the mobile devices 502, 506) may receive the more recent data from the DHP 510, such as described below. For example, when a user logs into a mobile application on other mobile devices, the mobile application may cause the mobile devices 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 may not request data from the inhalation device 100 because those mobile devices have already received the data from the DHP 510.

[0087] Thus, the inhalation device 100 may be configured to limit the number of times it transmits data to a mobile device (e.g., which may be any one of the mobile devices, and which may be a different mobile device during each data transfer). In this example, the mobile device is limited to a single transfer of 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, and the DHP 510 transfers the data to all other authorized external devices. However, if the mobile device is not limited to a single transfer of stored data, the same instance of 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).

[0088] More specifically, the DHP 510 may be configured to enable the transfer of data from the mobile devices 502, 504, 506, and in some cases initiate the transfer. For example, the DHP 510 may expose a REST API to a processor and / or mobile application resident on the mobile devices 502, 504, 506. The mobile devices 502, 504, 506 may send any data associated with the inhalation device 100 that has not yet been uploaded to the DHP 510 to the DHP 510, and send with this data any combination of an indication of the associated user and / or a timestamp of the data (which may include the local time and time zone of the mobile device). In some instances, the mobile devices 502, 504, 506 may be configured to periodically (e.g., every 15 minutes) send the inhalation data (or an indication that there is no new inhalation data) to the DHP 510. The DHP 510 may also store incoming data from the computer 512. The DHP 510 may receive the patient's permission via their respective mobile devices 502 , 504 , 506 .

[0089] DHP 510 can transfer data (such as inhaler data) to one or more of mobile devices 502, 504, 506. For example, DHP 510 can receive data from a mobile device, and then transfer the data to other mobile devices associated with the user, such as, when other mobile devices do not yet have the inhaler data. In some instances, mobile devices 502, 504, 506 can transfer the request to all new inhaler data associated with the user to DHP 510 (such as, periodically, such as every 15 minutes). The request can include at least one indication of the user and inhaler or medicament type (such as, emergency medicament type or maintenance medicament type). The request can also include the indication of the last synchronization time between the mobile device and the inhaler, regardless of whether any new inhaler related data is communicated to the mobile device from the inhaler. The last synchronization time of the mobile device can indicate the most recent time that the inhaler is connected to the mobile device, regardless of whether any new inhaler related data is communicated to the mobile device from the inhaler. DHP 510 can receive the request, determine the user, inhaler and / or medication type, and determine the last synchronization time between the mobile device and the inhaler. DHP 510 can then determine whether the DHP 510 has stored any data (e.g., use event) that postpones the synchronization time indicated by the request (appears after the synchronization time) by comparing the associated time stamp with the last synchronization time provided in the request. If there is data of the inhaler that appears after the last synchronization time, DHP 510 is configured to send the data and the associated time stamp to the mobile device (e.g., with any combination of data indicating the associated user, inhaler and / or medication type). The data sent by DHP 510 may include: data from the inhaler, such as a usage event, and a time stamp of the data (e.g., including the local average time and time zone of the event); inhaler information, such as data indicating medication type and / or dosage; and data indicating the user associated with the event.

[0090] Additionally, in some examples, the DHP 510 may return additional data related to the user and / or medicament, such as profile information related to the user, prescription order information, user preferences, questionnaire responses, etc. For example, 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, where information other than inhaler-related data (e.g., usage events) was received by the mobile device. The DHP 510 may then determine whether it has stored any other data (e.g., the data described above) that postpones the synchronization time indicated by the request, and if so, send the other data and associated timestamp (e.g., in conjunction with any combination of associated user, inhaler, and medicament type) to the mobile device.

[0091] 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 the plurality of mobile devices 502, 504, 506 associated with the inhalation device 100 have the most recent data associated with the inhalation device 100 and / or the user, regardless of the number of mobile devices 502, 504, 506 associated with the inhalation device 100 and / or the user. This is particularly true in instances where the mobile device is configured to periodically send 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 to the DHP, and also periodically send requests for new data that is not yet stored on the mobile device to the DHP.

[0092] In addition, the DHP 510 can cause a computer 512 associated with a health care provider to provide the inhaler data to physicians and health care professionals to allow them to view the inhaler data specifically for a procedure that the patient has authorized. In one example, the DHP 510 causes a computer 512 associated with a health care provider to provide the inhaler data via a graphical user interface (GUI) that is presented on a display device associated with the health care provider's computer.

[0093] DHP 510 can define any number of programs, which can be configured and changed by health care providers in some cases. When inhaler data is provided to health care providers, DHP 510 can produce an alarm specific to a specific program associated with health care providers (e.g., produce and provide GUI). Program definition criteria set, such as the type of medicine (e.g., first aid and / or any combination of maintenance medicaments), specific patients and then its applicable inhaler, other users of program (e.g., specific doctors, practice groups and / or administrators), the type of data presented to health care providers (e.g., charts, event tables, use overviews, etc.). Health care providers can use DHP 510 to configure and set up any number of programs. In addition, specific patients and their inhalers can be associated with any number of unique programs. In some instances, programs are stored and maintained by DHP 510, and the computer 512 associated with health care providers is configured to use, for example, application programs (e.g., dashboards or web applications) to access the data relevant to each program from DHP 510. In such an example, and 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 health care provider (e.g., via a dashboard). The program data may include inhaler data specifically configured for a particular program, and additional data derived from the inhaler data, such as described in more detail below. For example, the DHP 510 may enable a GUI (such as those described herein) on a computer 512 associated with the health care provider that presents the program data to the health care provider.

[0094] For example, DHP 510 can include a dashboard application that can be accessed by a computer 512 associated with a health care provider. In some instances, the dashboard application is a web application (e.g., a web portal). For example, DHP 510 is configured to provide data (e.g., inhaler data) to a clinician and a doctor by using a dashboard application (e.g., via a REST API). DHP 510 can make a computer 512 associated with a health care provider provide inhaler data to a physician and a health care professional to allow them to view the inhaler data of a specific program that has been permitted for a patient. In an example, DHP 510 makes a computer 512 associated with a health care provider provide inhalation data via a graphical user interface (GUI) that is presented on the computer of the health care provider.

[0095] 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 transmit a notification to the inhalation device 100 indicating that the inhalation data was 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 it receives a request for the data. However, the mobile application may be configured to transmit the inhalation data to the mobile device that postpones the upload of the data to the DHP 510.

[0096] Alternatively or in addition, in some instances, system 100 may be configured to make inhalation device 100 can only transmit data to a single mobile device.For example, when the mobile application on mobile device 504 (for example, initially) is connected to inhalation device 100 and / or receives data from inhalation device 100, inhalation device 100 can receive and store the ID associated with mobile device 504.After receiving ID, inhalation device 100 can be limited to data connection and transmission to mobile device 504 and / or any another device with same ID.If other external devices such as mobile device 502,506 attempt to be connected to inhalation device 100, if such device has different IDs, inhalation device 100 does not transmit data so.Therefore, for example, electronic module 120 can save power by limiting its situation of being connected to external device and transmitting the data collected by sensor system 128.

[0097] All or a portion of the data transmitted 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 a health care provider. The data may also be accessed or retrieved by a corresponding mobile application on the mobile devices 502, 506. Thus, even though the inhalation device 100 may be limited to connecting to and / or transmitting data to the mobile device 504, 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.

[0098] In addition, in some examples, such as when the suction device 100 is in the connection mode, the suction device 100 can limit the frequency of communicating data with the external device (e.g., mobile device). This can allow the suction device 100 to save battery power, for example, when it is in the connection mode. The communication protocol implemented by the suction device 100 can, for example, include parameters that limit the frequency of the request for data that the suction device 100 will accept when it is in the connection mode. The parameter can, for example, allow the suction device 100 to skip the connection event and the external device does not discard the connection, and therefore, although the suction device 100 skips the connection event, the suction device 100 can remain in the connection mode. In this example, the suction device 100 can set this parameter to its maximum value. For example, if the suction device 100 uses BLE to communicate, the suction device 100 can configure the parameter "connSlaveLatency" to a maximum value (e.g., every 2 seconds, every 4 seconds, etc.)

[0099] In addition, in some examples, the suction device 100 does not include an actuator, a button or a switch in order to start the pairing process with the mobile device. However, the suction device 100 may include other components for promoting the pairing process. For example, the suction device 100 may include a bar code, such as a quick response (QR) code 160. Although described as a QR code, other types of bar codes may be used. Use the QR code to further reduce the required battery / power consumption of the electronic module 120 of the suction device 100 with the initial pairing process. In addition, although the QR code 160 is described as being positioned on the top of the top cover 102 of the suction device 100, in other examples, the suction device 100 may include a QR code positioned at other places on the suction device 100, such as, positioned on the main housing 104 or on the mouthpiece cover 108. The mobile device may include a camera, and the mobile application program residing on the mobile device may be configured to access the camera and read the QR code 160.

[0100] The QR code 160 may include (e.g., decoded to indicate) various types of information associated with the inhalation device 100. The QR code 160 may include a BLE key that is unique to the inhalation device 100. Upon reading or scanning the QR code 160 using a camera, the mobile application may determine the BLE key associated with the device 100 and complete an authentication process, thereby enabling the device 100 to communicate with the electronic module 120 using the BLE key. If the communication session is subsequently lost due to, for example, the inhalation device 100 being moved out of range, the mobile device may be configured to automatically pair with the electronic module 120 using the BLE key without using the QR code 160 when the inhalation device 100 is back in range.

[0101] Additionally, in some examples, the QR code 160 may include an indication of the type of inhalation device 100 (eg, medication type, number of doses, strength, dosing schedule, etc.). Table 1 provides non-limiting examples of identifiers included in QR codes 160 for various inhalation devices 100.

[0102]

[0103] Table 1

[0104] As shown in Table 1, the identifier further indicates the dosage strength and the total dose count of the inhaler before use. The mobile application resident on the mobile device can use the identifier in conjunction with the usage information to control the user interface of the mobile device to issue a notification when the dose recommended by the label has been exceeded, as previously described. Alternatively or in addition, the mobile application resident on the mobile device can use the total dose count of the inhaler before use and the usage information to determine the number of doses remaining in the corresponding inhalation device 100.

[0105] The QR code 160 on the inhalation device 100 may, for example, further include a security key, for example in the form of a series of alphanumeric characters, for preventing unauthorized users from accessing the respective inhalation device 100. The mobile application resident on the mobile device may be able to decrypt the respective encrypted data after the mobile application has the security key, but may not be able to decrypt the respective encrypted data before the mobile application has the security key. More generally, the security key may be included in the respective identifier.

[0106] 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.

[0107] In such an example, a key, such as provided in a QR code, may allow synchronization between the respective inhalation device 100 and the mobile application of the system. The key and, in turn, the usage parameter data (e.g., inhalation and / or usage data) from the respective inhalation device may be public. This public inhalation data may not be associated with a specific individual until synchronized with a single user account.

[0108] Since the system is configured to limit the corresponding inhaler to be associated with a single user account, the corresponding inhaler can be prevented from synchronizing with another user account, for example, in the event that the inhaler is lost or stolen. In this way, third parties can be prevented from obtaining usage parameter data that is not theirs.

[0109] Therefore, the mobile application can determine the type of the inhalation device 100 when receiving the QR code 160 (e.g., the type of medicament, the strength of administration, and the number of doses), and before the inhalation device 100 is used for the first time by the user. For example, the mobile application can use the camera of the mobile device to receive (e.g., capture) the image of the QR code. The mobile application can then decode the image of the QR code to obtain the data stored in the QR code. In some examples, the QR code 160 may include a multi-digit alphanumeric code, such as a six-digit code (e.g., ssm060, aaa200, etc.) indicating the type of the inhalation device 100. For example, the multi-digit alphanumeric code may be a unique drug identifier (e.g., product ID) of the inhalation device 100. Therefore, the QR code 160 can directly convey the type of the inhalation device 100 (e.g., the type of medicine, the number of doses, the strength, the administration plan, etc.) via the multi-digit alphanumeric code provided by the QR code 160 (e.g., and therefore, the mobile application does not have to use the QR code 160 to access the website to obtain the type of the inhalation device). The multi-digit alphanumeric code "AAA030" may, for example, indicate that the drug type is albuterol, the strength is 117 mcg, and the number of doses is 30.

[0110] In some examples, the BLE key provided via the QR code 160 may include, for example, a multi-digit alphanumeric number. Additionally, in some embodiments, the QR code 160 may not directly indicate to the mobile application information related to the medication type, number of doses, strength, dosing schedule, etc. of the inhalation device 100. Rather, the QR code 160 may include information that can be used by the mobile application to obtain such information related to the inhalation device 100 from a remote device (e.g., a cloud-based system, such as a remote server).

[0111] Furthermore, in some examples, the QR code 160 may include any combination of a serial number of the inhalation device 100, a hardware revision number of the inhalation device 100, and / or a 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 bar code) indicating the type of the inhalation device 100, a communication key (e.g., a BLE key), a manufacturer's name of the inhalation device 100, a serial number of the inhalation device 100, a hardware revision number of the inhalation device 100, a software revision number of the inhalation device 100, and / or the like.

[0112] After receiving the QR code 160, the mobile application can, for example, directly determine the details of the inhalation device 100 (e.g., drug type, number of doses, strength, dosing schedule, etc.) through the multi-digit alphanumeric provided by the QR code 160. Alternatively or in addition, in some examples, the mobile application can be configured to send a request (e.g., which includes a multi-digit alphanumeric code) to the DHP 510 for details related to the inhalation device 100 (e.g., drug type, number of doses, strength, dosing schedule, etc.). This can be particularly important, for example, in situations where mislabeling problems may occur and the inhalation device 100 is mislabeled with an incorrect type of drug. The use of the QR code 160 allows, for example, accurate details related to the inhalation device 100 to be obtained by the mobile application before the user uses the inhalation device 100. This can, for example, help prevent problems related to incorrect dosing reminders, incorrect refill warnings, etc. based on incorrect dosing schedules, which otherwise may have been determined based on incorrect drug labels on the inhalation device 100. In addition, in some examples, the mobile application can determine that the drug and / or dosage strength indicated by the QR code is not prescribed to the user associated with the mobile application. For example, the mobile application may send 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 medication type or strength of the inhaler from the cloud-based server (e.g., such as a direct compatible or incompatible message, or an indication of the medication type and strength associated with the user). For example, the mobile application may request and receive the user's prescription information from the DHP 510. And the mobile application may generate an alert (e.g., displayed on the mobile device and / or a GUI at a computer associated with the HCP) indicating that the user has an incorrect inhaler based on the medication type or strength as indicated by the QR code. Additionally, in this case, the mobile application may reject the pairing process with the inhalation device 100.

[0113] In addition, in some instances, mobile application can be used together with the suction device of specific type, but not all.Therefore, if the information indication suction device 100 provided by QR code 160 is not a suction device compatible with mobile application, mobile application can display error message so.In addition, mobile application can provide the link to mobile application store to download the correct mobile application for the suction device 100 of described type.If for example mobile application determines that suction device is not compatible with mobile application (for example, based on QR code 160 or multi-bit alphanumeric code), mobile application can refuse the pairing process of suction device 100 and mobile device so (for example, before data transmission or using suction device 100 for the first time).If mobile application determines that suction device is compatible with mobile application (for example, based on QR code 160 or multi-bit alphanumeric code), mobile application can accept or allow the pairing process of suction device 100 and mobile device so.

[0114] Figure 6 is a graph 600 of example air flow rate versus pressure. Figure 6 The airflow rates and distributions shown in are examples only, and the determined rates may depend on the size, shape, and design of the inhalation device 100 and its components.

[0115] The electronic module 120 can generate data (e.g., a usage event) by comparing the signal received from the sensor system 128 and / or the determined airflow measurement to one or more thresholds or ranges, for example as part of evaluating whether the use and / or use of the inhalation device 100 is likely to result in the delivery of a full dose of medication. For example, in the case where the determined airflow measurement corresponds to an inhalation at an airflow rate below a certain threshold, the electronic module 120 can determine that there is no inhalation or insufficient inhalation from the mouthpiece 106 of the inhalation device 100. If the determined airflow measurement corresponds to an inhalation at an airflow rate above a certain threshold, the electronic module 120 can determine that there has been an excessive inhalation from the mouthpiece 106. If the determined airflow measurement corresponds to an inhalation at an airflow rate within a certain range, the electronic module 120 can determine that the inhalation is "good" or is likely to result in the delivery of a full dose of medication. The electronic module 120 can associate a timestamp with the data.

[0116] The pressure measurement readings and / or calculated airflow metrics may indicate the quality or intensity of the inhalation from the inhalation device 100. For example, when compared to a particular threshold or value range, the readings and / or metrics may be used to classify the 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 inhalation may be a usage parameter stored as individualized data.

[0117] A no-inhalation event may be associated with a pressure measurement reading and / or an airflow metric that is below a certain threshold (e.g., an airflow rate of less than or equal to 30 Lpm). A no-inhalation event may occur when the individual does not inhale from the mouthpiece 106 after opening the mouthpiece cover 108 and during the measurement cycle. A no-inhalation event may also occur when the individual's inhalation force is insufficient to ensure proper delivery of the drug via the flow path 119, for example, when the inhalation force does not generate enough airflow to activate the deagglomerator 121 and thereby aerosolize the drug in the dosing cup 116.

[0118] A low inhalation event may be associated with a pressure measurement reading and / or an airflow metric within a specific range (e.g., an airflow rate greater than 30 Lpm and less than or equal to 45 Lpm). A low inhalation event may occur when an individual inhales from the mouthpiece 106 after opening the mouthpiece cover 108 and the individual's inhalation force causes at least a portion of the dose of the drug to be delivered via the flow path 119. That is, the inhalation may be sufficient to activate the deagglomerator 121, causing at least a portion of the drug to be aerosolized from the dosing cup 116.

[0119] A good inhalation event can be associated with a pressure measurement reading and / or an airflow metric (e.g., an airflow rate greater than 45 Lpm and less than or equal to 200 Lpm) that is higher than a low inhalation event. A good inhalation event can occur when the individual inhales from the mouthpiece 106 after opening the mouthpiece cover 108 and the individual's inhalation force is sufficient to ensure proper delivery of the drug via the flow path 119, such as when the inhalation force generates an airflow sufficient to activate the deagglomerator 121 and atomize a complete dose of the drug in the dosing cup 116.

[0120] Excessive inhalation events may be associated with pressure measurement readings and / or airflow metrics (e.g., airflow rates above 200 Lpm) that are higher than good inhalation events. Excessive inhalation events may occur when the inhalation force of an individual exceeds the normal operating parameters of the inhalation device 100. If the device 100 is not properly positioned or held during use, an excessive inhalation event may also occur even if the inhalation force of the individual is within the normal range. For example, if the vents (e.g., by a finger or thumb) are blocked or obstructed when the individual inhales from the mouthpiece 106, the calculated airflow rate may exceed 200 Lpm.

[0121] Any suitable threshold or range may be used to classify specific events. Some or all of the events may be used. For example, no inhalation events may be associated with airflow rates less than or equal to 45 Lpm, and good inhalation events may be associated with airflow rates greater than 45 Lpm and less than or equal to 200 Lpm. Thus, in some cases, low inhalation events may not be used at all.

[0122] The pressure measurement readings and / or the calculated airflow metrics may also indicate the direction of flow through the flow path 119 of the inhalation device 100. For example, if the pressure measurement readings reflect a negative change in pressure, then the readings may indicate air flowing out of the mouthpiece 106 via the flow path 119. If the pressure measurement readings reflect a positive change in pressure, then the readings may indicate air flowing into the mouthpiece 106 via the flow path 119. Thus, the pressure measurement readings and / or the airflow metrics may be used to determine whether the individual is exhaling into the mouthpiece 106, which may indicate that the individual is not using the device 100 properly.

[0123] The inhalation device 100 may include a spirometer or similar operating device to enable measurement of lung function metrics. For example, the inhalation device 100 may perform measurements to obtain metrics related to the lung capacity of an individual. The spirometer or similar operating device may measure the amount of air inhaled and / or exhaled by an individual. The spirometer or similar operating device may use a pressure sensor, ultrasound, or a water level gauge to detect changes in the amount of air inhaled and / or exhaled.

[0124] Data collected from or calculated based on the use of the inhalation device 100 (e.g., pressure metrics, airflow metrics, lung function metrics, dose confirmation information, etc.) may also be (e.g., partially or fully) calculated and / or evaluated via an external device. More specifically, the wireless communication circuit 129 in the electronic module 120 may include a transmitter and / or receiver (e.g., a transceiver) and additional circuitry.

[0125] For example, wireless communication circuit 129 may include a Bluetooth chipset (e.g., a Bluetooth low power chipset), a ZigBee chipset, a Thread chipset, etc. Therefore, electronic module 120 may provide data (e.g., pressure measurements, airflow metrics, lung function metrics, dosage confirmation metrics, and / or other conditions associated with the use of inhalation device 100) wirelessly to a mobile device. Electronic module 120 may also send a timestamp associated with the data. Data may be provided to an external device in real time so that risk of deterioration may be predicted based on real-time data from inhalation device 100, the real-time data indicating the use time, the mode of use of inhalation device 100, and personalized data about an individual, such as real-time data associated with individual lung function and / or medical treatment. The external device may include software for processing received information and for providing compliance and compliance feedback to an individual via a graphical user interface (GUI) (e.g., via a mobile device or via a computer associated with an HCP).

[0126] The airflow metric may include personalized data collected from the inhalation device 100 in real time, such as the average flow rate of inhalation / exhalation, the peak flow rate of inhalation / exhalation (e.g., the maximum inhalation received), the amount of inhalation / exhalation, the time to reach the inhalation / exhalation peak, and / or the duration of inhalation / exhalation. The airflow metric may also indicate the flow direction through the flow path 119. That is, a negative change in pressure may correspond to an inhalation from the mouthpiece 106, and a positive change in pressure may correspond to an exhalation entering the mouthpiece 106. When calculating the airflow metric, the electronic module 120 may be configured to eliminate or minimize any distortion caused by environmental conditions. For example, the electronic module 120 may be re-zeroed to take into account the change in atmospheric pressure before or after calculating the airflow metric. One or more pressure measurements and / or airflow metrics may be time stamped and stored in the memory of the electronic module 120.

[0127] In addition to airflow measurement, the inhalation device 100 or another computing device can use airflow measurement to generate additional data.For example, the controller of the electronic module 120 of the inhalation device 100 can convert the airflow measurement into other measurement of the pulmonary function and / or lung health of the indication individual understood by the practitioner, such as peak inhalation flow measurement, peak expiratory flow measurement, and / or 1 second forced expiratory volume (FEV1). The electronic module 120 of the inhaler can use a mathematical model such as a regression model to determine the degree of individual pulmonary function and / or lung health. The mathematical model can identify the correlation between the total amount of inhalation and FEV1. The mathematical model can identify the correlation between the peak inhalation flow and FEV1. The mathematical model can identify the correlation between the total amount of inhalation and the peak expiratory flow. The mathematical model can identify the correlation between the peak inhalation flow and the peak expiratory flow.

[0128] Other variations to the disclosed embodiments may be understood and effected by those skilled in the art in practicing the claimed invention by studying the drawings, the disclosure and the appended claims. In the claims, the word "comprising" does not exclude other elements or steps and the indefinite article "a" or "an" does not exclude a plurality. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage. Any reference signs in the claims should not be construed as limiting the scope.

Claims

1. A system comprising a drug delivery device having electronics and power management, comprising: a server including a processor, memory, and communication circuitry; an inhaler comprising a mouthpiece, a medicament, and an electronic module comprising a processor, a memory, and a communication circuit; a first computer-readable storage medium residing on a first mobile device, wherein the first computer-readable storage medium includes computer-executable instructions that, 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 ingested data and the timestamp to the server; and a second computer-readable storage medium residing on a second mobile device, wherein the second computer-readable storage medium includes computer-executable instructions that, when executed by a processor of the second mobile device, cause the processor of the second mobile device to: transmitting a request for the inhalation data to the server, wherein the request includes a timestamp of the most recent inhalation data for the inhaler stored on the second mobile device; and The inhalation data for the inhaler is received from the server in response to the request, wherein a timestamp associated with the received inhalation data is subsequent to a timestamp of most recent inhalation data for the inhaler stored on the second mobile device.

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

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

4. The system of claim 1, wherein the system is configured to limit the number of times the inhaler transmits the inhalation data to any mobile device to a single time.

5. The system of claim 1, wherein the second computer-readable storage medium is configured to cause the processor of the second mobile device to transmit a request for inhalation data to the inhaler, wherein The request includes a timestamp of the most recent inhalation data for the inhaler stored on the second mobile device.

6. The system of claim 1, wherein the inhaler further comprises a quick response code; and wherein the first mobile device further comprises a camera, and the first computer-readable storage medium is configured to cause the processor of the first mobile device to: receiving, using the camera of the first mobile device, an image of the quick response code of the inhaler; determining a product identifier for the inhaler based on the image of the quick response code; determining a dosing schedule for the inhaler using the product identifier; and An alarm is generated based on the dosing schedule of the inhaler indicating that a scheduled dose is due.

7. The system of claim 1, wherein the inhaler further comprises a quick response code; and wherein the first mobile device further comprises a camera, and the first computer-readable storage medium is configured to cause the processor of the first mobile device to: receiving, using the camera of the first mobile device, an image of the quick response code of the inhaler, wherein the quick response code provides a product identifier of the inhaler; determining one or more of a drug type or a strength of the drug based on the product identifier; determining that the inhaler is not compatible with the first computer-readable storage medium or a user associated with the inhaler based on the medication type or the strength of the inhaler; and An error message is generated 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.

8. The system of claim 7, wherein the first computer-readable storage medium is configured to cause the processor of the first mobile device to: sending the medication type or the strength of the inhaler to the server; and An indication of compatibility of the user with the medication type or the strength of the inhaler is received from the server.

9. The system of claim 7, wherein the first computer-readable storage medium is configured to cause the processor of the first mobile device to reject a pairing process of the inhaler with the first mobile device based on the inhaler being incompatible with the first computer-readable storage medium.

10. The system of claim 1, wherein the inhaler further comprises a quick response code, but the inhaler does not include an actuator, button, or switch to initiate a communication pairing process with the first mobile device.

11. The system of claim 10, wherein the first computer-readable storage medium is configured to cause the processor of the first mobile device to: receiving an image of the quick response code of the inhaler using a camera of the first mobile device; determining a communication key unique to the inhaler based on the quick response code; and The communication key is transmitted to the electronic module of the inhaler to enable communication between the electronic module and the first computer-readable storage medium.

12. The system of claim 11, wherein the communication key comprises a product identifier and a Bluetooth low energy key.

13. A system comprising a drug delivery device having electronics and power management, comprising: a server including a processor, memory, and communication circuitry; an inhaler comprising a mouthpiece, a medicament, and an electronic module comprising a processor, a memory, and a communication circuit; a first computer-readable storage medium residing on a first mobile device, wherein the first computer-readable storage medium includes computer-executable instructions that, 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 ingested data and the timestamp to the server; and a second computer-readable storage medium residing on a second mobile device, wherein the second computer-readable storage medium includes computer-executable instructions that, 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 before causing the second computer-readable storage medium to transmit a request for inhalation data to the inhaler, transmitting to the server a request including a timestamp of most recent inhalation data for the inhaler stored on the second computer-readable storage medium; and The inhalation data for the inhaler is received from the server in response to the request, wherein the timestamp associated with the inhalation data is subsequent to the timestamp of the most recent inhalation data for the inhaler stored on the second computer-readable storage medium.

14. The system of claim 13, wherein the system is configured to limit the number of times the inhaler transmits the inhalation data to any mobile device to a single time.

15. The system of claim 13, wherein the second computer-readable storage medium is configured to cause the processor of the second mobile device to transmit a product identification associated with the inhaler or a patient ID associated with a patient of the inhaler to the server before the second computer-readable storage medium receives the inhalation data of the inhaler from the server.

16. The system of claim 13, wherein the second computer-readable storage medium is configured to cause the processor of the second mobile device to periodically transmit the request to the server including the timestamp of the most recent inhalation data of the inhaler stored on the second computer-readable storage medium.

17. The system of claim 13, wherein the second computer-readable storage medium is configured to cause the processor of the second mobile device to transmit a request to the inhaler, receive second inhalation data from the inhaler, and transmit the second inhalation data and an associated timestamp to the server; and wherein the first computer-readable storage medium is configured to cause the processor of the first mobile device to transmit a request including an indication of a last synchronization time between the first computer-readable storage medium and the inhaler to the server, and to receive the second inhalation data and the associated timestamp for the inhaler from the server, wherein the timestamp associated with the second inhalation data is after the last synchronization time between the first computer-readable storage medium and the inhaler.

18. The system of claim 13, wherein the electronic module of the inhaler is configured to: starting a counter in response to the electronic module changing from a deactivated state to an activated state for the first time; recording the inhalation data in response to use of the inhaler by a user; associating a counter value with the inhalation data; and sending the intake data and the counter value to the first mobile device; and Wherein 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, wherein the timestamp indicates a local average time of the ingested data based on a time zone of the first mobile device.

19. The system of claim 13, wherein the inhaler is configured to dispense discrete doses of the medicament, and wherein the medicament comprises one of: Salbutamol sulfate, 117 mcg of albuterol sulfate per discrete dose; Fluticasone propionate, 55mcg, 113mcg, or 232mcg fluticasone propionate per discrete dose; or Fluticasone propionate is combined with salmeterol xinafoate, with each discrete dose being 55mcg, 113mcg or 232mcg of fluticasone propionate and 14mcg of salmeterol xinafoate.

20. The system of claim 13, wherein the agent comprises one of the following: albuterol sulfate, fluticasone propionate or furoate, beclomethasone dipropionate, or fluticasone propionate or furoate in combination with salmeterol.

21. The system of claim 13, wherein the inhaler further comprises a quick response code; and wherein the first mobile device further comprises a camera, and the first computer-readable storage medium is configured to cause the processor of the first mobile device to: receiving, using the camera of the first mobile device, an image of the quick response code of the inhaler; determining a product identifier for the inhaler based on the image of the quick response code; determining a dosing schedule for the inhaler using the product identifier; and An alarm is generated based on the dosing schedule of the inhaler indicating that a scheduled dose is due.

22. A system comprising a drug delivery device having electronics and power management, comprising: a server including a processor, memory, and communication circuitry; an electronic module configured to be attached to and removed from the inhaler, the electronic module comprising a processor, memory, and communication circuitry; a first computer-readable storage medium residing on a first mobile device, wherein the first computer-readable storage medium includes computer-executable instructions that, 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 the electronic module; receiving the usage data from the electronic module, the usage data being associated with a time stamp; and transmitting the usage data and the timestamp to the server; and a second computer-readable storage medium residing on a second mobile device, wherein the second computer-readable storage medium includes computer-executable instructions that, when executed by a processor of the second mobile device, cause the processor of the second mobile device to: transmitting a request for the usage data of the electronic module to the server, wherein the request includes a timestamp of the most recent usage data of the electronic module stored on the second mobile device; and The usage data of the inhaler is received from the server in response to the request, wherein a timestamp associated with the received usage data is subsequent to a timestamp of most recent usage data of the electronic module stored on the second mobile device.

23. A system according to claim 22, wherein the second computer-readable storage medium is configured so that the processor of the second mobile device transmits a product identification associated with the electronic module or a patient ID associated with a patient of the electronic module to the server before the second computer-readable storage medium receives the usage data of the electronic module from the server.

24. The system of claim 22, wherein the second computer-readable storage medium is configured to cause the processor of the second mobile device to transmit a request to ingest data to the electronic module, wherein: The request includes a timestamp of most recent usage data of the electronic module stored on the second mobile device.

Images