Drug delivery device with electronics

Abstract

The system may include an external device and an inhaler. The external device may include a processor, a communication circuit, and a memory. The inhaler may include a mouthpiece, a medicine, a mechanical dose counter, and an electronic module including a processor and a communication circuit. The electronic module may record a dosing event when the inhaler is actuated (such as when the mouthpiece cover is opened), and send a signal indicating the dosing event to the external device. The external device may receive the mechanical dose reading of the mechanical dose counter, determine the electronic dose reading based on the signal indicating the dosing event, determine that the difference between the mechanical dose reading and the electronic dose reading exceeds a threshold value, and notify the user of the difference, for example, by providing notification to the user by means of a mobile application resident on the external device.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 849,552, filed May 17, 2019, the disclosure of which is incorporated herein by reference in its entirety. Background Art

[0003] Drug delivery devices facilitate the delivery of drugs into the patient via various routes of administration. Typical routes of administration include oral, topical, sublingual inhalation, injection, etc. The device can be used to deliver drugs for the treatment of various diseases, ailments, and medical conditions. For example, inhalation devices can be used to treat asthma, chronic obstructive pulmonary disease (COPD), and cystic fibrosis (CF). Although drug delivery devices are designed to provide patients with appropriate doses of drugs as part of treatment, the effectiveness of a particular treatment may be affected by non-physiological factors, such as the patient's persistence and compliance.

[0004] In the context of drug therapy, adherence can refer to the degree to which a patient follows the prescribed dosing regimen. For example, if a patient's prescription calls for two doses per day, and the patient takes both doses per day, then the patient can be considered 100% adherent. If the patient only takes one dose per day, then he or she can be considered only 50% adherent. In the latter case, the patient may not be taking the treatment his or her doctor prescribed, which can negatively impact the effectiveness of the treatment.

[0005] Compliance can refer to a patient's skill in using a specific drug delivery device. If the patient uses the device in the manner recommended by the doctor or manufacturer, the device is likely to deliver the desired dose of the drug, and the patient can be considered compliant. However, if the device is not used correctly during drug administration, the ability of the device to deliver the appropriate dose of the drug will be affected. In this way, the patient can be considered non-compliant. For example, in the case of an inhalation device, the patient may need to achieve a minimum inhalation effort to ensure that the full dose of the drug is delivered from the device to the patient's lungs. For some patients (such as children and the elderly), due to physical limitations (such as limited lung function), it may be difficult to meet the requirements of full compliance. Thus, like adherence, failure to achieve full compliance will reduce the effectiveness of the prescribed treatment.

[0006] The patient's ability to achieve full compliance may be further complicated by certain physical properties of medications. For example, some respiratory medications may contain fine particles and / or may not have any odor or taste. As a result, a patient using an inhalation device may not be able to correct non-compliant use because he or she may not be able to immediately detect or sense that the medication is being inhaled and / or know whether the amount of medication inhaled is in accordance with the prescription. Summary of the invention

[0007] A system may include an external device and an inhalation device (e.g., an inhaler). The external device may include a processor, a communication circuit, and a memory. The inhaler may include a nozzle, a medicament, a mechanical dose counter, and an electronic module, and the electronic module includes a processor, a communication circuit, and a sensor, and the sensor is configured to measure the airflow (e.g., such as the flow channel through the inhaler) through the inhaler. When the nozzle cover of the inhaler moves from an open position to a closed position (e.g., to cover the nozzle), the mechanical dose counter may be decremented. For example, the sensor may include any combination of sensors, such as a pressure sensor, a temperature sensor, a humidity sensor, an acoustic sensor, an optical sensor, a direction sensor, etc. The pressure sensor may be configured to measure the pressure change (e.g., such as a pressure drop) through the inhaler. The acoustic sensor may be configured to measure the air flowing through the acoustic sensor. The sensor may be configured to measure the frequency at which the capsule collides with the capsule holder of the inhaler. The optical sensor may be configured to measure the passing of the powder particles through the sensor.

[0008] When the mouthpiece cover of the inhaler moves from the closed position to the open position to expose the mouthpiece to the user, the electronic module can record the dosing event. The electronic module can include a processor that can perform the processing described herein. The electronic module can include a switch that is actuated when the mouthpiece cover of the inhaler moves from the closed position to the open position. The switch can be used to change the electronic module between power states (for example, between a closed or sleep state and an active state). Alternatively or additionally, when the feedback from the sensor exceeds a threshold value (for example, when the pressure measurement value from the pressure sensor exceeds a threshold value), the electronic module can record the dosing event. For example, in some examples, the electronic module (for example, and / or the mobile application residing on the external device) can be configured to use the feedback from the sensor to verify the dosing event triggered based on the mouthpiece cover moving from the closed position to the open position. For example, the electronic module can determine whether the feedback from the sensor indicates a good or normal inhalation, and if so, the dosing event triggered based on the mouthpiece cover moving from the closed position to the open position can be verified with this determination result. The electronic module can be configured to send a signal indicating a dosing event to an external device (e.g., the signal can be an electronic dose reading (e.g., an accumulation of dosing events), the signal can include a dosing event (e.g., where the dosing event is based on actuation of a switch, based on an inhalation parameter determined from sensor data exceeding a threshold, etc.), and / or the signal can be raw data from a sensor.

[0009] The external device may determine (e.g., receive) a mechanical dose reading of the mechanical dose counter. For example, the external device may determine the mechanical dose reading using a camera of the external device (e.g., by prompting the user to take a picture of the mechanical dose counter or hold the camera of the external device over the mechanical dose counter), may prompt the user to manually enter the mechanical dose reading into the external device (e.g., into a mobile application resident on the external device) to determine the mechanical dose reading, and / or may determine the mechanical dose reading by direct entry by a technician (e.g., if the inhaler is returned to the vendor or its agent due to misuse or any other reason).

[0010] The external device may determine the electronic dose reading based on the signal indicating the dosing event. For example, the external device may increment the electronic dose reading for each signal indicating a dosing event received from the electronic module. Alternatively or additionally, the electronic module may determine the electronic dose reading based on the recorded dosing event and send the electronic dose reading to the external device.

[0011] The external device can determine that the difference between the mechanical dose reading and the electronic dose reading exceeds a threshold value and notify the user, the supplier of the inhaler, and / or a healthcare provider (HCP) of the difference. For example, the external device can notify the user of the difference by providing a notification to the user via a mobile application resident on the external device, by illuminating one or more light emitting diodes (LEDs) of the inhaler, by outputting an audible signal via a speaker of the inhaler or the external device, by sending a text, email, or instant message to the external device or the DHP, and / or by providing a notification to the DHP.

[0012] Inhaler can comprise main body, and this main body comprises mouthpiece and mouthpiece cover, medicine and sensor, and this sensor is configured to measure the airflow (for example, such as the flow channel by inhaler) by inhaler.For example, sensor can comprise any combination of sensor, such as pressure sensor, temperature sensor, humidity sensor, acoustic sensor, optical sensor, towards sensor etc.Pressure sensor can be configured to measure the pressure change (for example, such as pressure drop) by inhaler.Acoustic sensor can be configured to measure the air flowing through acoustic sensor.Sensor can be configured to measure the frequency that capsule collides with the capsule holder of inhaler.Optical sensor can be configured to measure the powder particles by the passing through of sensor.

[0013] Inhaler can comprise multiple dose counters, such as mechanical dose counter and electrical dose counter, two different electrical dose counters, etc.Mechanical dose counter and electrical dose counter (for example, and possible multiple different electrical dose counters) can be triggered based on different actuation or action that occurs at inhaler place so that the dose counted increases or decreases.For example, mechanical dose counter can be configured to decrease when mouthpiece cover moves from open position to closed position to cover mouthpiece to user, and electronic dose counter can be configured to record dosage event and / or when the measured value from pressure sensor exceeds threshold value (for example, when flow rate exceeds threshold value or falls within specific range) when mouthpiece cover moves from closed position to open position to expose mouthpiece.

[0014] Inhaler can comprise communication circuit, and this communication circuit is configured to send the signal of indication dosage event to external device.Inhaler can determine that the difference between mechanical dose counter and electronic dose counter exceeds threshold value, and can be configured to notify this difference to user.For example, inhaler can provide notification to user by means of the mobile application that resides on external device, by lighting one or more light emitting diodes (LED) of inhaler, by outputting audible signal via the loudspeaker of inhaler or external device, by sending text, email or instant message to external device or DHP and / or by providing notification to DHP, notify this difference to user.

[0015] The difference between mechanical dose counter and electronic dose counter indicates that inhaler has defect and / or user has misuse or misoperation to inhaler.For example, the defect of inhaler may cause mechanical dose counter and / or electronic dose counter to operate incorrectly.This defect also can cause the dosage delivery machinery of inhaler to misoperate, and this can stop the user from receiving the medicine of appropriate dose.In addition, the difference between dose counter can indicate user's misuse or misoperation to inhaler, if detects difference, so can prevent and correct this situation earlier.Inhaler and / or external device can be configured to provide notification (for example, feedback, such as alarm) when the difference between two or more dose readings (for example, mechanical dose reading and electrical dose reading) exceeds threshold value, wherein notification reminds user or HCP inhaler has defect and / or user has misuse or misoperation to inhaler.

[0016] Inhaler can comprise main body, and this main body comprises mouthpiece and medicine.Inhaler can also comprise electronic module, and this electronic module comprises processor, memory, the temperature sensor that is configured to measure the temperature inside or around of inhaler, and the humidity sensor that is configured to measure the humidity inside or around of inhaler.Electronic module can determine that temperature measurement value falls outside temperature range and / or humidity measurement value falls outside humidity range.Electronic module can notify user that temperature measurement value falls outside temperature range and / or humidity measurement value falls outside humidity range to notify user.For example, electronic module can send the signal that indication temperature measurement value falls outside temperature range or humidity measurement value falls outside humidity range to notify user to external device.

[0017] In some examples, the electronic module may also include an orientation sensor configured to perform orientation measurements. In such examples, the electronic module may determine that the inhalation device is in an incorrect position during actuation of the inhaler to prepare a dose of medication for delivery to a user or during delivery of a dose of medication to a user, and may notify the user that the inhalation device is in an incorrect position.

[0018] In some examples, the electronic module can also include a pressure sensor configured to measure the pressure change in the inhaler. In such examples, the electronic module can determine that the pressure measurement value exceeds the threshold value indicating the delivery of a dose of medicine to the user, and based on the pressure measurement value record inhalation event. The electronic module can associate the temperature measurement value and the humidity measurement value with the inhalation event. The inhaler can use the associated temperature measurement value and the humidity measurement value to determine the efficacy of the delivery of the drug dose. Alternatively or additionally, the electronic module can send the inhalation event and the associated temperature measurement value and the humidity measurement value to an external device, and the external device can use the associated temperature measurement value and the humidity measurement value to determine the efficacy of the delivery of a dose of medicine.

[0019] The electronic module may include a second pressure sensor configured to measure a pressure change at a second location within the inhaler. In this case, the electronic module may determine that the pressure measurement from each of the two pressure sensors exceeds a threshold value and record a partial occlusion event based on the determination result.

[0020] The inhaler can detect when the inhaler is removed from the bag. For example, the electronic module can periodically receive humidity measurements from the humidity sensor, determine that the humidity change between subsequent humidity measurements exceeds a threshold, and record an "out of bag" event based on the humidity change.

[0021] A system may include an inhaler and a smart bag. The inhaler may include a mouthpiece and a medication. The smart bag may include a communication circuit, a humidity sensor configured to measure humidity in or near the smart bag, and a processor. The smart bag may be configured to determine when the inhaler is removed from the bag and record in a memory that the inhaler is removed from the bag. For example, the processor of the smart bag may determine that the humidity change between subsequent humidity measurements exceeds a threshold, record an "out-of-bag" event based on the change in humidity, and send the "out-of-bag event" to one or more of the inhaler or an external device. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 is a front perspective view of an example inhalation device.

[0023] Figure 2 is a cross-sectional interior perspective view of an example inhalation device.

[0024] Figure 3 is an exploded side perspective view of the internal components of the inhalation device.

[0025] Figure 4A and Figure 4B is an enlarged perspective view of an example dose counter for an inhalation device.

[0026] Figure 5 is an exploded perspective view of the inhalation device with the top cap removed to expose the electronics module.

[0027] Figure 6 is an exploded perspective view of the top cap and electronic module of the inhalation device.

[0028] Fig. 7A is a partial cross-sectional view of an inhalation device with a mouthpiece cover of the inhalation device in a closed position.

[0029] Figure 7B is a partial cross-sectional view of an inhalation device with the mouthpiece cover in a partially open position.

[0030] Figure 7C is a partial cross-sectional view of an inhalation device with the mouthpiece cover in a partially open position.

[0031] Fig.7D is a partial cross-sectional view of an inhalation device with the mouthpiece cover in a fully open position.

[0032] Figure 8 is a graph of an exemplary relationship between pressure measurements and airflow rate through a flow passage of an inhalation device.

[0033] Fig. 9 is a diagram of an example system including an inhalation device. DETAILED DESCRIPTION

[0034] The present disclosure describes devices, systems and methods for sensing, tracking and / or processing usage conditions and parameters associated with a drug delivery device. These 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 technical solutions are equally applicable to other drug delivery devices, such as syringes, metered dose inhalers, nebulizers, transdermal patches or implantable devices.

[0035] Asthma and COPD are chronic inflammatory diseases of the airways. They are both characterized by variable and recurring symptoms of airflow obstruction and bronchospasm. Symptoms include 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.

[0036] Inhaled corticosteroids (ICS) are steroid hormones used for long-term control of respiratory disorders. They work by reducing airway inflammation. Examples include budesonide, beclomethasone (dipropionate / dipropionate HFA), fluticasone (propionate), mometasone (furoate), ciclesonide, and dexamethasone (sodium). Brackets indicate example (e.g., preferred) salt or ester forms.

[0037] Different classes of bronchodilators target different receptors in the airways. Two commonly used categories are beta2-agonists and anticholinergics. Beta2-adrenergic agonists (or "beta2-agonists") act on beta2-adrenergic receptors that induce smooth muscle relaxation, resulting in bronchial dilation. They tend to be classified by duration of action. Examples of long-acting beta2 agonists (LABAs) include formoterol (fumarate), salmeterol (xinaphate), indacaterol (maleate), bambuterol (hydrochloride), clenbuterol (hydrochloride), olodaterol (hydrochloride), carmoterol (hydrochloride), tulobuterol (hydrochloride), and vilanterol (triphenyl acetate). Examples of short-acting beta2-agonists (SABAs) are salbutamol (sulfate) and terbutaline (sulfate).

[0038] Typically short-acting bronchodilators provide rapid relief of acute bronchoconstriction (and are often referred to as "rescue" or "relief" drugs), while long-acting bronchodilators help control and prevent long-term symptoms. However, some fast-acting long-acting bronchodilators can be used as emergency medications, such as formoterol (fumarate). Therefore, rescue medication can relieve acute bronchoconstriction. Rescue medication is taken as needed / prn (on the spot). Rescue medication can also be in the form of a combination product, such as ICS-formoterol (fumarate), typically budesonide-formoterol (fumarate) or beclomethasone (dipropionate)-formoterol (fumarate). Therefore, rescue medication is preferably SABA or fast-acting LABA, more preferably salbutamol (sulfate) or formoterol (fumarate), most preferably salbutamol (sulfate).

[0039] Anticholinergics (or "antimuscarinics") block the neurotransmitter acetylcholine by selectively blocking acetylcholine receptors in nerve cells. When applied topically, anticholinergics act primarily on M3 muscarinic receptors located in the airways 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).

[0040] A variety of approaches have been taken in preparing and formulating these drugs for delivery by inhalation, such as via dry powder inhalers (DPIs), pressurized metered dose inhalers (pMDIs), or nebulizers.

[0041] According to the GINA (Global Initiative for Asthma) guidelines, a stepwise approach can be taken to treat asthma. In step 1, which represents mild asthma, patients are given SABAs such as albuterol sulfate as needed. Patients may also be given low-dose ICS-formoterol as needed, or low-dose ICS whenever SABA is taken. In step 2, conventional low-dose ICS is given with SABA, or low-dose ICS-formoterol is given as needed. In step 3, LABA is added. In step 4, the dose is increased, and in step 5, further additional treatments are included, such as anticholinergics or low-dose oral corticosteroids. Therefore, the corresponding steps can be regarded as treatment plans, each of which is configured according to the acute severity of the respiratory disease.

[0042] COPD is the leading cause of death worldwide. It is a heterogeneous, long-term disease that includes chronic bronchitis, emphysema, and involvement of the small airways. Pathological changes that occur in COPD patients 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.

[0043] Bronchitis is characterized by long-term inflammation of the bronchi. Common symptoms can include wheezing, shortness of breath, coughing and expectoration, all of which are very uncomfortable and detrimental to the patient's quality of life. Emphysema is also associated with long-term bronchial inflammation, in which the inflammatory response causes the lung tissue to break down and the airways to gradually narrow. Over time, the lung tissue loses its natural elasticity and becomes larger. In this way, the efficiency of gas exchange decreases, and the breathed air is often trapped within the lungs. This causes local hypoxia and reduces the amount of oxygen delivered to the patient's blood with each inhalation. As a result, patients experience shortness of breath and difficulty breathing.

[0044] Patients with COPD experience various, if not all, of these symptoms every day. Their severity will be determined by a range of factors, but most commonly it is associated with the progression of the disease. Regardless of their severity, these symptoms indicate stable COPD, and this disease state is maintained and controlled by the administration of a variety of medications. Treatment methods vary, but often include inhaled bronchodilators, anticholinergics, long-acting and short-acting beta2 receptor agonists, and corticosteroids. Drugs are often administered as monotherapy or as combination therapy.

[0045] 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 AD and the recommended first-choice treatments varied by category. Patients in group A were recommended to use a short-acting muscarinic antagonist (SAMA) prn or a short-acting beta2-agonist (SABA) prn. Patients in group B were recommended to use a long-acting muscarinic antagonist (LAMA) prn or a long-acting beta2-agonist (LABA). Patients in group C were recommended to use an inhaled corticosteroid (ICS) + LABA or LAMA. Patients in group D were recommended to use ICS + LABA and / or LAMA.

[0046] Patients with respiratory diseases such as asthma or COPD suffer from periodic exacerbations that exceed the baseline daily variation of their condition. An exacerbation is an acute worsening of respiratory symptoms that requires additional therapy, ie, therapy beyond their maintenance therapy.

[0047] For asthma, add-on therapy for moderate exacerbations is repeated doses of a SABA, oral corticosteroids, and / or controlled-flow oxygen (the latter requiring hospitalization). Severe exacerbations add an anticholinergic (usually ipratropium), a nebulized SABA, or IV magnesium sulfate.

[0048] For COPD, add-on therapy for moderate exacerbations is repeated doses of SABA, oral corticosteroids, and / or antibiotics. Severe exacerbations add controlled flow oxygen and / or respiratory support (both requiring hospitalization). Exacerbations within the meaning of this disclosure include both moderate exacerbations and severe exacerbations.

[0049] Figure 1 100. It is a front perspective view of an example suction device 100. For example, the suction device 100 can be a breath-actuated suction device. The suction device 100 can include a top cap 102, a main housing 104, a suction nozzle 106, a suction nozzle cover 108 and an exhaust port 125. The top cap 102 can be mechanically attached to the main housing 104. The suction nozzle cover 108 can be hinged to the main housing 104 so that it can open and close to expose the suction nozzle 106. Although it is shown as a hinge connection, the suction nozzle cover 108 can be connected to the suction device 100 by other types of connections. In addition, in some alternative embodiments, the suction nozzle cover 108 can be omitted.

[0050] Figure 2 It is a cross-sectional internal perspective view of the inhalation device 100. In the main housing 104, the inhalation device 100 can include a drug reservoir 110 and a dose delivery mechanism. For example, the inhalation device 100 can include a drug reservoir 110 (for example, a funnel), 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 can include a medicine for delivering to a user, such as a dry powder medicine. The yoke 118 can be mechanically coupled (for example, directly or indirectly) with the nozzle cover 108 so that the movement of the nozzle cover 108 can cause the movement of the yoke 118. For example, when the nozzle cover 108 is moved to expose the nozzle 106 (for example, from a closed position to an open position), the yoke 118 can move vertically (for example, toward or away from the top cap 102) in the inhalation device 100. Although the dose delivery mechanism is illustrated as a combination of the 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 examples, the medication may be included 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 including a dose of medication, and make the dose of medication available to the dosing chamber and / or mouthpiece for inhalation by the user.

[0051] exist Figure 1In the example dose delivery mechanism shown in , the movement of the yoke 118 can compress the bellows 112 and deliver a dose of medicine from the drug reservoir 110 to the dosing cup 116. Thereafter, the user can inhale through the mouthpiece 106 to receive the dose of medicine. The airflow generated by the user's inhalation can cause the deagglomerator 121 to atomize the dose of medicine by decomposing the clumps of medicine in the dosing cup 116. The deagglomerator 121 can be configured to atomize the medicine (e.g., completely) when the airflow through the flow passage 119 reaches or exceeds a certain rate or is within a specific range. When atomized, the dose of medicine can travel from the dosing cup 116 to the dosing chamber 117, through the flow passage 119, and out of the mouthpiece 106 to reach the user. If the airflow through the flow passage 119 does not reach or exceed a certain rate, or is not within a specific range, some or all of the medicine may remain in the dosing cup 116. In the case where the drug in the dosing cup 116 is not aerosolized by the deagglomerator 121, when the mouthpiece cover 108 is subsequently opened, another dose of the drug will not be delivered from the drug reservoir 110. Therefore, at least a portion of a dose of the drug can remain in the dosing cup until the dose has been aerosolized by the deagglomerator 121.

[0052] When the user inhales through the mouthpiece 106, air can enter the exhaust port 125 to provide an airflow to deliver the drug to the user. The flow path 119 can extend from the dosing chamber 117 to the end of the mouthpiece 106, and includes the dosing chamber 117 and the interior portion of the mouthpiece 106. The dosing cup 116 can be located in or near the dosing chamber 117.

[0053] Figure 3 It is the exploded rear perspective view of the internal assembly 101 of the inhalation device 100. The internal assembly 101 can be contained in the main housing 104. The internal assembly 101 can include a drug reservoir 110, which can include an open end 113 and a pressure relief system including a pressure relief port 123. The base of the drug reservoir 110 can be fixed to a spacer 138, which can be fixed to a deagglomerator 121. The deagglomerator 121 can include two diametrically opposite inlets 162, which extend tangentially to the circular cross section of the metering chamber 117. Radial blades (not shown) can be positioned at the top of the metering chamber 117 and can be sized so that at least a portion of the breath-driven air flow entering through the diametrically opposite inlets 162 collides with the radial blades. As mentioned above, when a dose of medicine is atomized, the dose can be advanced from the metering cup 116 to the metering chamber 117. The dose of medicament may then travel to the outlet 160 of the deagglomerator 121 and through the mouthpiece 106 for inhalation by the user.

[0054] The internal assembly 101 may include a dose metering system including a cup assembly 196. The cup assembly 196 may include a slide 127 with a cup 131 and a boss 133. The slide 127 of the cup assembly 196 may be slidably received in a sliding channel 152 of a spacer 138 below the drug reservoir 110. The cup slide 100 may be biased toward the delivery channel along the sliding channel 152 from a dispenser port (not shown) of the drug reservoir 110 by a cup spring 149, which may be fixed to the drug reservoir 110. The internal assembly 101 may include a dose counter 111, which may be mechanically coupled (e.g., directly or indirectly) to the nozzle cover 108 so that the dose counter 111 may be incremented or decremented when the nozzle is opened or closed. The dose counter 111 may be referred to as a mechanical dose counter, and the reading (e.g., count or number) displayed by the dose counter 111 may be referred to as a mechanical dose reading. The dose counter 111 may initially be set to the number of total doses of the drug inside the drug reservoir 110. As such, the dose counter 111 may be configured to decrement by one each time the nozzle cover 108 moves from an open position to a closed position (or from a closed position to an open position), thereby indicating the number of remaining doses within the drug reservoir 110. Alternatively, the dose counter 111 may initially be set to zero and may be configured to increment by one each time the nozzle cover 108 moves from an open position to a closed position (or from a closed position to an open position), thereby indicating the total number of doses delivered from the drug reservoir 110.

[0055] Although the dose counter 111 of the inhaler 100 is illustrated as being mechanically coupled to the mouthpiece cover 108, in alternative embodiments, such as when the inhalation device 100 includes a different dose delivery mechanism, the dose counter 111 of the inhaler 100 may be coupled (e.g., mechanically coupled) to other components of the inhalation device 100 to increment or decrement. For example, the dose counter 111 may be coupled (e.g., mechanically coupled) to a switch, lever, or twist cap that, for example, prepares a dose of medication for inhalation by a user.

[0056] Figure 4A and Figure 4B 1 is an enlarged perspective view of a dose counter 111 of the inhalation device 100. The dose counter 111 may include a strip 137, which may have sequential numbers or other suitable indicia printed thereon. The indicia may be in contrast to a transparent window 147 (see FIG. 1 ) provided in the housing 104. Figure 2 ) is aligned. The dose counter 111 may include a rotatable bobbin 153 and a rotatable indexing spool 157. The tape 137 may be rolled up and received on the bobbin 153. The first end 161 of the bobbin 153 may be fixed to the spool 157. When the tape 137 is unwound from the bobbin 132, the markings may be displayed sequentially as the spool 157 rotates or advances.

[0057] The spool 157 can be arranged to rotate along with the movement of the yoke 118, and the movement of the yoke 118 can cause a dose of medicine to be delivered to the dosing cup 116 from the reservoir 110. As such, the mark (e.g., number) on the band 137 can advance to indicate that another dose has been dispensed by the inhalation device 100. The mark on the band 137 can be arranged to increase or decrease along with the rotation of the spool 157. For example, when the spool 157 rotates, the number can be reduced to indicate the number of doses remaining in the inhalation device 100, or when the spool 157 rotates, the number can be increased to indicate the number of doses dispensed by the inhalation device 100. The spool 157 can include radially extending teeth 169, which can be configured to engage the pawl (not shown) on the yoke 118. The pawl can be configured to engage the teeth 169 and advance the indexing spool 157 when the yoke 118 moves (e.g., when the mouthpiece cover 108 is opened or closed).

[0058] The dose counter 111 may include a chassis 171 configured to secure the dose counter 111 to the reservoir 110. The chassis may include one or more shafts 173 for receiving the bobbin 153 and the indexing spool 157. The shaft 173 may be bifurcated and may include one or more radial projections 175 that may be configured to produce a resilient resistance to rotation of the bobbin 153 and / or the spool 157 on the shaft 173. A clutch spring 177 may be received on the end of the indexing spool 157 and secured (e.g., locked) to the chassis 171 to allow the spool 157 to rotate in a single direction (e.g., clockwise or counterclockwise).

[0059] Figure 5 100 is an exploded perspective view of an example inhalation device 100, wherein the top cap 102 is removed to expose an electronic module 120. The top cap 102 can accommodate the electronic module 120, which 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 cap 102 can be attached to the main housing 104 via one or more clips (not shown), which engage with a groove on the main housing 104. For example, the top cap 102 can overlap with a part of the main housing 104 when connected, so that there is a pneumatic seal between the top cap 102 and the main housing 104. The top surface of the main housing 104 can include one or more (e.g., two) orifices 146. One of the orifices 146 can be configured to accept a slider 140. For example, when the top cap 102 is attached to the main housing 104, the slider 140 can protrude through the top surface of the main housing 104 via one of the orifices 146. The top cap 102 may be removably attached to the main housing 104. Alternatively or additionally, the electronic module 120 may be integrated within the main housing 104 and / or the top cap 102 housing the electronic module 120 may be permanently attached to the main housing 104.

[0060] In addition, in some examples, electronic module 120 can reside in a separate device separated from the inhalation device 100 outside the inhalation device 100. For example, electronic module 120 can reside in an accessory device, which is constructed to be attached to the inhalation device 100 and is removed from the inhalation device 100 subsequently (for example, when the inhalation device 100 runs out of medicine or expires). In such cases, when the user receives a new inhalation device 100 each time, the user can attach the accessory device comprising electronic module 120 to another inhalation device from an inhalation device 100. Accessory device can be constructed to be attached to any parts of the inhalation device 100 (such as main housing 104, suction nozzle and / or the medicine tank in the main housing 104 of the main housing 104 of the inhalation device 100) (for example, so that the sensor is communicated with the suction nozzle and / or the flow channel fluid of the inhalation device 100).

[0061] Figure 6 1 is an exploded perspective view of the top cap 102 and the electronic module 120. Figure 6 As shown in FIG. 1 , the slider 140 can define an arm 142, a stop 144, and a distal base 145. The distal end 145 can be a bottom portion of the slider 140. The distal end 145 of the slider 140 can be configured to abut the yoke 118 located within the main housing 104. The top cap 102 can include a slider guide 148 that is configured to receive a slider spring 146 and the slider 140. The slider spring 146 can be located within the slider guide 148. The slider spring 146 can engage an inner surface of the top cap 102, and the slider spring 146 can engage (e.g., abut) an upper portion (e.g., a proximal end) of the slider 140.

[0062] When the slider 140 is installed in the slider guide 148, the slider spring 146 can be partially compressed between the top of the slider 140 and the inner surface of the top cap 102. For example, the slider spring 146 can be configured so that the distal end 145 of the slider 140 remains in contact with the yoke 118 when the nozzle cover 108 is closed. The distal end 145 of the slider 145 can also remain in contact with the yoke 118 when the nozzle cover 108 is opened or closed. For example, the stop 144 of the slider 140 can engage the stop of the slider guide 148 so that the slider 140 is held in the slider guide 148 by the opening and closing of the nozzle cover 108, and vice versa. The stop 144 and the slider guide 148 can be configured to limit the vertical (e.g., axial) travel of the slider 140. This limit can be less than the vertical travel of the yoke 118. Therefore, when the nozzle cover 108 moves to the open position, the yoke 118 can continue to move toward the nozzle 106 in the vertical direction, but the stopper 144 can stop the vertical travel of the slider 140 so that the distal end 145 of the slider 140 can no longer contact the yoke 118.

[0063] The electronic module 120 may include one or more components, such as a sensor system 128, a wireless communication circuit 129, a switch 130, a power source (e.g., a battery 126), a battery holder 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 may be used interchangeably. One or more of the components of the electronic module 120 may be mounted on 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 include computer executable instructions that, when executed by the controller, cause the controller to implement the processing of the electronic module as described herein.

[0064] 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 customer identification module (SIM) card, a memory stick, a secure digital (SD) memory card, etc. The memory can be inside the controller. The controller can also access data from a memory that is not physically located in the electronic module 120 and store the data therein, such as a memory on a server or a smart phone.

[0065] The battery 126 can provide power to the components of the PCB 122. The battery 126 can be any suitable power source for powering the electronic module 120, such as a button cell. 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 fixed to the PCB 122 so that the battery 126 maintains 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 can 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.

[0066] Switch 130 can be actuated by the dose delivery mechanism of inhalation device 100.When using the example dose delivery mechanism described herein to combine, switch 130 can be actuated by slide 140 when mouthpiece cover 108 moves from closed position to open position.But it should be appreciated that it is understood that if inhalation device 100 includes different dose delivery mechanisms, switch 130 can be actuated by the different components of dose delivery mechanism so.When switch 130 is actuated, electronic module 120 can generate the signal that makes electronic module 120 change state, such as changing to active state from closing or sleeping state.When in active state, the controller of electronic module 120 can wake up and power sensor system 128 so that sensor system 128 can obtain measurement reading.In addition, each time switch 130 is actuated, electronic module 120 can store dosing event (for example, it can be referred to as dose delivery event or actuation event).As described in more detail below, electronic module 120 can have multiple power states, and each power state has corresponding power consumption level. For example, the electronic module 120 can be configured to operate in a system off state, a sleep 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 sleep 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, an advertising mode that may be faster than the sleep state, and / or a timer or clock).

[0067] The sensor system 128 may include one or more sensors, such as one or more pressure sensors, temperature sensors, humidity sensors, acoustic sensors, optical sensors, orientation sensors, etc. The pressure sensor(s) may include a barometric pressure sensor (e.g., an atmospheric pressure sensor), a differential pressure sensor, an absolute pressure sensor, etc. The sensors may employ microelectromechanical systems (MEMS) and / or nanoelectromechanical systems (NEMS) technology. The pressure sensor(s) may be configured to provide instantaneous pressure readings and / or aggregated pressure readings over time to the controller of the electronic module 120. Figure 2 and Figure 5 As shown in , the pressure sensor(s) may reside within the inhalation device 100 but remain outside of the flow path 119. Thus, the pressure sensor(s) may be configured to measure multiple atmospheric pressures within the inhalation device 100.

[0068] The electronic module 120 (e.g., and / or a mobile application residing on an external device) can use the measurements from the sensor system 128 to determine one or more dosing events. 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).

[0069] The temperature sensor(s) may include a thermistor, a thermocouple, a resistance temperature detector, a temperature sensor chip, etc. The temperature sensor(s) may be configured to provide a temperature reading and / or an aggregated temperature reading over time to a controller of the electronic module 120. The temperature sensor(s) may be configured to measure the external temperature in a space near the inhalation device 100. Thus, the main housing 104 and / or the top cap 102 may include an opening (e.g., an exhaust port) to allow the temperature sensor(s) to measure the ambient temperature outside the housing.

[0070] Alternatively or additionally, the temperature sensor(s) may be configured to measure a temperature within the inhalation device 100, such as a temperature within one or more of the top cap 102, the main housing 104, and / or the mouthpiece 106 of the inhalation device 100. The ability to measure both internal and external temperatures may allow the electronic module 120 to determine operating temperatures of components of the electronic module 120, the temperature of air flowing through the inhalation device 100 when a user inhales through the inhalation device 100, and the like. Thus, the electronic module 120 may be configured to detect an overheat or undertemperature condition, such as an overheat condition of one or more components of the electronic module 120 (e.g., such as another sensor, such as a pressure sensor), an overheat condition of the inhalation device 100, an ambient temperature exceeding a threshold, and the like. The electronic module 120 may be configured to cause the communication circuit 129 to transmit a temperature message to an external device (e.g., a mobile device) indicating an overheat condition, an ambient temperature reading, and / or a temperature reading inside the inhalation device 100 (e.g., such as a temperature change detected through a flow channel of the inhalation device 100).

[0071] The temperature sensor(s) may be located on the electronic module 120. For example, in some embodiments, the temperature sensor(s) may be embedded within a pressure sensor (e.g., embedded within an atmospheric pressure sensor). The temperature of other components of the electronic module 120 and / or the temperature of a user's hand may affect the temperature sensor's measurements. Thus, in some embodiments, at least a portion of the temperature sensor(s) may be located outside the electronic module 120, such as within the main housing 104. In such examples, the temperature sensor(s) may include an electronic connection to a controller of the electronic module 120. Additionally, to avoid being affected by the temperature of the user's hand, the temperature sensor(s) may be located on the front 103 of the main housing 104 or on the bottom 107 of the main housing 104. For example, the temperature sensor(s) may be located within an area 105 on the front side 103 of the main housing 104 near (e.g., above) the exhaust port 125 (e.g., as shown in FIG. 1 ). Figure 5 The temperature sensor(s) may also be located on the bottom 107 of the main housing 104 so that, for example, the nozzle cover 108 may prevent a user from placing their fingers near the temperature sensor(s) when the nozzle cover 108 is in the open position.

[0072] The temperature sensor(s) may be configured to take temperature measurements when the electronic module 120 is in an active state (e.g., when in an active measurement mode, as described herein). For example, the temperature sensor(s) may be configured to take temperature measurements at the same time as the pressure sensor takes pressure measurements, which may be, for example, a predetermined amount of time (e.g., 1-3 minutes) after the nozzle cover 108 is moved to the open position. Alternatively or additionally, the temperature sensor(s) may periodically take pressure measurements when the nozzle cover 108 is in a closed state (e.g., when the electronic module 120 periodically wakes up from a sleep state to enter an advertising state).

[0073] The humidity sensor(s) may include capacitive sensors, resistive sensors, thermal conductivity sensors, etc. The humidity sensor(s) may be configured to provide humidity readings and / or aggregated humidity readings over time to a controller of the electronic module 120 .

[0074] The humidity sensor(s) may be configured to measure environmental conditions (e.g., external humidity levels in the area surrounding the inhalation device 100) and / or humidity levels within a specific location within the inhalation device 100. The humidity sensor(s) may be configured to measure relative humidity.

[0075] The humidity sensor(s) may be located on the electronic module 120. For example, the humidity sensor(s) may be incorporated into the electronic module 120. The humidity sensor(s) may be affected by moisture from the user's hands. Thus, in some embodiments, at least a portion of the humidity sensor(s) may be located outside the electronic module 120, such as within the main housing 104. In such examples, the humidity sensor(s) may include an electronic connection to a controller of the electronic module 120. Additionally, to avoid being affected by moisture from the user's hands, the humidity sensor(s) may be located on the front 103 of the main housing 104 or on the bottom 107 of the main housing 104. For example, the humidity sensor(s) may be located on the front side 103 of the main housing 104 (e.g., above the exhaust port 125) within an area 105 (e.g., such as Figure 5 The humidity sensor(s) may also be located on the bottom 107 of the main housing 104 so that, for example, when the nozzle cover 108 is in the open position, the nozzle cover 108 may prevent a user from placing their fingers near the humidity sensor(s).

[0076] (One or more) humidity sensor can be configured to measure humidity, such as the ambient humidity outside the suction device 100. Thus, main housing 104 and / or top cap 102 can comprise opening (for example, exhaust port) to allow (one or more) humidity sensor to measure the ambient humidity outside the housing. Alternatively or additionally, (one or more) humidity sensor can be configured to measure the humidity in the suction device 100, such as the humidity in one or more in the top cap 102, main housing 104 and / or the suction nozzle 106 of the suction device 100. The ability of measuring internal and external humidity can allow electronic module 120 to determine whether dry powder medicine has the risk of caking. Thus, electronic module 120 can be configured to detect the situation that humidity is too high or too low, and can be configured to make communication circuit 129 transmit humidity message to external device (for example, mobile device).

[0077] The humidity sensor(s) may be configured to perform humidity measurements when the electronic module 120 is in an active state (e.g., when in an active measurement mode, as described herein). For example, the humidity sensor(s) may be configured to perform humidity measurements at the same time as the pressure sensor performs pressure measurements, which may be, for example, a predetermined amount of time (e.g., 1-3 minutes) after the nozzle cover 108 is moved to the open position. Alternatively or additionally, the humidity sensor(s) may periodically perform pressure measurements when the nozzle cover 108 is in a closed state (e.g., when the electronic module 120 periodically wakes up from a sleep state to enter an advertising state).

[0078] The orientation sensor(s) may include an accelerometer, a gravity (G) sensor, a gyroscope, a magnetometer, etc. The orientation sensor(s) may be configured to provide orientation readings (e.g., acceleration, rotation, direction, etc.) and / or aggregated orientation readings over time to a controller of the electronic module 120. The orientation sensor(s) may be located on the electronic module 120. For example, the orientation sensor(s) may be incorporated into the electronic module 120.

[0079] (One or more) orientation sensors can be configured to perform orientation measurements when the electronic module 120 is in an active state (e.g., when in an active measurement mode, as described herein). For example, (one or more) orientation sensors can be configured to perform orientation measurements while a pressure sensor performs pressure measurements, which can be, for example, a predetermined amount of time (e.g., 1-3 minutes) after the nozzle cover 108 moves to the open position. Thus, the electronic module 120 can be configured to use feedback from (one or more) orientation sensors to determine whether the inhalation device 100 is in the correct orientation when a dose of medicine is metered from the medicine reservoir 110 to the dosing cup 116 and / or during the user inhaling the dose of medicine.

[0080] For example, the electronic module 120 can use the feedback from the orientation sensor to determine whether the suction device 100 is used in an incorrect position, such as inverted (that is, cap 102 is oriented below the mouthpiece 106). The incorrect orientation of the suction device 100 (for example, or any pMDI) can indicate the misuse of the suction device 100, for example, because the medicine may not be properly applied when the suction device 100 is in an incorrect position. In addition, some users use the suction device 100 when lying down. Thus, the feedback from the orientation sensor allows the electronic module 120 to determine and notify the user that the use of the inhaler (for example, the delivery of the medicine, the preparation of the medicine, such as valve refilling, etc.) is negatively affected, and therefore the drug dosage may not be properly delivered.

[0081] The controller of the electronic module 120 can receive a signal corresponding to the reading from the sensor system 128. The controller can use the signal received from the sensor system 128 to calculate, estimate, or otherwise determine one or more parameters (e.g., peak flow rate, time to peak flow rate, inhalation volume, inhalation duration, temperature, humidity level, orientation of the inhalation device 100, etc.). For example, the flow rate parameter can indicate the curve of the airflow through the flow passage 119 of the inhalation device 100. For example, if the pressure sensor(s) record a pressure change of 0.3 kilopascals (kPA), the electronic module 120 can determine that the change corresponds to an airflow rate of approximately 45 liters per minute (Lpm) through the flow passage 119. Figure 8A graph 800 is depicted showing an example relationship between pressure measurements obtained by the sensor system 128 and the air flow rate through the flow passage 119. It will be appreciated that Figure 8 The curves shown in are exemplary only, and the determined airflow rate may depend on the size, shape and / or design of the inhalation device 100 and its internal components.

[0082] As reference Fig. 9 Described in more detail, the inhalation device 100 may include a communication circuit, such as a Bluetooth radio transceiver, for transmitting data to an external device (e.g., mobile device 902, wearable device, etc.). The external device may include software (e.g., mobile application) or a web interface to allow display data to a user. The inhalation device 100 may transmit the data received from one or more sensors of the inhalation device 100 to the external device. For example, the temperature and humidity data determined by the temperature and humidity sensor may indicate the microenvironment in which the inhalation device 100 is used (e.g., contrary to the more general weather data based on the position of the external device). The situation in which the inhalation device 100 is used (e.g., it may be indoor) may be different from general weather information based on position.

[0083] As mentioned above, sensor (for example, temperature, humidity and / or towards sensor) can detect measured value when inhaler uses or can carry out periodic measurement.In addition, electronic module 120 can determine the baseline humidity measured value of the day that takes out suction device 100 from the protective bag.Bag can be the packaging that suction device 100 is delivered to user before the user uses suction device 100 for the first time.For example, suction device 100 can be in controlled low humidity environment when taking out from bag.After this, if regularly carry out humidity measurement, suction device 100 can determine humidity peak so.

[0084] The inhalation device 100 may detect when it is removed from the bag, for example, based on measurements received from the sensor system 128. The inhalation device 100 may generate an out-of-bag event upon detecting that it has been removed from the bag. The out-of-bag event may indicate one or more characteristics of the inhalation device 100 when it is removed from the bag, such as, but not limited to, the time of removal from the bag, the relative temperature or humidity of the inhalation device 100 and / or the environment when the inhalation device is removed from the bag, and the like.

[0085] Inhalation device 100 can also detect whether it has been removed from the bag and / or the delay amount between the inhalation device 100 being taken out of the bag and the first use of the inhalation device 100, for example, based on the measured value received from sensor system 128 (for example, such as humidity changes exceeding a specific threshold value). In addition, inhalation device 100 can determine the "out-of-bag" time, which can be the total time period after the inhalation device 100 has been removed from the bag (for example, and the life span of the inhaler can be indicated). Inhalation device 100 can record when the inhalation device 100 is removed from the bag, record the total time of the inhalation device 100 outside the bag, and provide notification to the user (for example, possibly via mobile application) when the out-of-bag time exceeds the threshold time period (for example, rather than based on the total number of dosing events or the time period starting from the first use of the inhalation device 100).

[0086] In some examples, the bag can be a smart bag. For example, a smart bag can correspond to a bag including an electronic device (e.g., all or a subset of components such as an electronic module 120). For example, the electronic device of the smart bag can be configured to determine the humidity and / or temperature of the environment of the inhalation device 100 when the inhalation device 100 is removed from the bag. The smart bag can then transmit the temperature and / or humidity measurement value (potentially together with the timestamp of the time when the inhalation device 100 is removed from the bag) to an external device and / or the inhalation device 100. In some examples, the bag and / or the inhalation device 100 can include a near field communication (NFC) chipset, and the bag and / or the inhalation device 100 can use the NFC communication protocol to detect when the inhalation device 100 is removed from the bag.

[0087] Suction device 100 can receive temperature and / or humidity measurement value (for example, as determined by opening of mouthpiece cover 108 and / or by the pressure measurement value that exceeds the threshold value of indication suction) periodically and / or when using inhaler.Suction device 100 and / or external device can use periodic temperature and / or humidity measurement to monitor and determine that suction device 100 is stored in the situation wherein.If temperature and / or humidity measurement value exceed the limit of instruction for use (IFU) definition (for example, if measurement value exceeds limit once, exceeds limit repeatedly in predetermined time period etc.), suction device 100 and / or external device can warn user so.Suction device 100 and / or external device can determine the temperature and / or humidity of suction device 100 (for example, and / or the environment around suction device 100) when suction device 100 is used.For example, if suction device 100 is used or stored in hot and / or humid environment, such as in bathroom or shower, the dry powder medicine of suction device 100 can be adversely affected so.

[0088] The inhalation device 100 (e.g., and / or an external device) can be configured to determine or predict that the inhalation device 100 may malfunction based on the temperature and / or humidity measurements. For example, if the temperature and / or humidity measurements indicate that the inhalation device 100 is used in an environment where the temperature or humidity is above a predetermined threshold or is above the threshold for a predetermined number of uses (e.g., above the threshold for more than 10 times), then the inhalation device 100 can determine that the inhalation device 100 is likely to malfunction or malfunction, and the inhalation device 100 can warn the user accordingly (e.g., by using an onboard LED, through an external device, etc.).

[0089] In some examples, the inhalation device 100 may include a plurality of pressure sensors. In such cases, the pressure sensor may be located at different places in the inhalation device 100. Thus, the inhalation device 100 may be configured to detect the partial obstruction of the inhalation device 100 based on the difference between the pressure measurements of a plurality of pressure sensors exceeding a predetermined threshold. For example, the inhalation device 100 may be configured to determine that medicine (e.g., dry powder medicine) is blocking the exhaust port 125 based on the difference between the pressure measurements of a plurality of pressure sensors exceeding a predetermined threshold. The inhalation device 100 may provide notification to the manufacturer or health care provider (HCP) of the user, inhaler based on the difference between the pressure measurements of a plurality of pressure sensors exceeding a predetermined threshold. The inhalation device 100 may directly provide notification (e.g., audio alarm and / or light source) and / or data and / or notification may be sent to an external device (e.g., smart phone), and the external device may provide notification to the user.

[0090] The humidity and / or temperature at which the inhalation device 100 is used may affect the delivery of medication to the user's lungs. For example, the user's lungs / airways may be more open at higher humidity and more constricted at cooler temperatures. Thus, the delivery of medication by the inhalation device 100 may be affected by the relaxation or constriction of the airways, which may, for example, result in controlled or uncontrolled asthma in the user.

[0091] The controller of the electronic module 120 can compare the signal received from the sensor system 128 and / or the determined parameter with one or more threshold values ​​or ranges, for example, as part of an assessment of how the inhalation device 100 is used, the condition of the inhalation device 100 used or stored, and / or whether the use or storage will affect the delivery of a dose of medicine. For example, when the determined airflow metric corresponds to an inhalation with an airflow rate below a specific 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 metric corresponds to an inhalation with an airflow rate above a specific threshold, the electronic module 120 can determine that there is an excessive inhalation from the mouthpiece 106. If the determined airflow metric corresponds to an inhalation with an airflow rate within a specific range, the electronic module 120 can determine that the inhalation is "good", or may result in the delivery of a full dose of medicine.

[0092] As described above, the electronic module 120 may include an indicator, such as an LED. The indicator may be configured to provide feedback to the user regarding their use of the inhalation device 100 and / or the condition in which the inhalation device 100 is used or stored. Thus, in one example, if the orientation of the inhalation device 100 falls outside the orientation range (e.g., any measured orientation angle is not consistent with the optimal orientation angle (e.g., Figure 1 and Figure 2 ) are greater than forty-five (45) degrees compared to the axis "A" shown in the IFU), the electronic module 120 can cause the LED to illuminate, change color, and / or flash. Similarly, if the ambient and / or internal temperature of the inhalation device 100 falls outside the temperature range (e.g., outside the storage range specified for the inhalation device 100), the electronic module 120 can cause the LED to illuminate, change color, and / or flash. In addition, if the ambient and / or internal humidity of the inhalation device 100 falls outside the humidity range, the electronic module 120 can cause the LED to illuminate, change color, and / or flash. In some examples, the humidity range is a relative humidity range specified in the IFU, for example, which can be associated with a specific time period (e.g., for humidity above a specific value, it is 13 months for an inhaler containing albuterol and 1 month for an inhaler containing fluticasone).

[0093] Although described as being performed at the inhalation device 100, it is possible to calculate and / or evaluate parameters via one or more external devices (e.g., partially or entirely). More specifically, the wireless communication circuit 129 in the electronic module 120 may include a transmitter and / or a receiver (e.g., a transceiver) and an additional circuit system. For example, the wireless communication circuit 129 may include a Bluetooth chipset (e.g., a Bluetooth low-power chipset), a ZigBee chipset, a Thread chipset, etc. As such, the electronic module 120 may provide data (e.g., parameters determined by a controller, such as pressure measurements, temperature, humidity levels, inhaler direction) wirelessly to external devices including smart phones. The external device may include information for processing received and for providing compliance and adhering to feedback and / or any notification described herein to the user of the inhalation device 100 via a graphical user interface (GUI).

[0094] Figures 7A-7D An example of the internal operation of the inhalation device 100 is described when the mouthpiece cover 108 is opened to expose the mouthpiece 106 and make a dose of medicament available to the flow passage 119. It should be appreciated that other examples of the inhalation device 100 may include a subset of the actions described herein. Fig. 7A , the distal end 145 of the slider 140 can be configured to abut the yoke 118 located within the main housing 104. When the nozzle cover 108 is in the closed position, the arm 142 of the slider 140 cannot contact the switch 130. In addition, the slider spring 144 and the bellows spring 114 can be in a compressed state. When the nozzle cover 108 is opened to expose the nozzle 106, the yoke 118 can move upward in the main housing 104, for example due to the mechanical connection between the yoke 118 and the nozzle cover 108. The upward movement of the yoke 118 can cause the slider 140 to move upward within the top cap 102, further compressing the slider spring 144 and the bellows spring 114, for example, Figure 7B as shown in .

[0095] As the nozzle cover 108 continues to move toward the fully open state, for example Figure 7C As shown in , the nozzle cover 108 can cause the yoke 118 to fall into the main housing 104 (e.g., due to the downward force applied by the bellows spring 114). The movement of the yoke 118 can cause the slider 140 to drop (e.g., due to the downward force applied by the slider spring 144), which can cause the arm 142 of the slider 140 to engage the switch 130 and begin to actuate the switch 130. Since the distal end 145 of the slider 140 can rest on the top of the yoke 118, the downward movement of the slider 140 can be limited by the position of the yoke 118.

[0096] like Fig.7DAs shown in , as the nozzle cover 108 continues to open, the arm 142 of the slider 140 can (e.g., fully) actuate the switch 130, which can generate a signal that causes the electronic module 120 to change state, such as from an off or sleep state to an active state. As a result, 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. Moreover, the movement of the yoke 118 caused by the opening of the nozzle cover 108 can also cause the yoke 118 to compress the bellows 112 so that a dose of medication is delivered from the medication reservoir 110 to the dosing cup 116, thereby causing the medication to reach the flow channel 119. When the user inhales from the nozzle 106, the medication can be delivered from the dosing cup 116 through the flow channel and discharged from the nozzle 106. In addition, when the nozzle cover 108 reaches a fully open position (e.g., as shown in ). Fig.7D ), the slider 140 may no longer be in contact with the yoke 118 (eg, the stopper 144 may stop the vertical movement of the slider 140 such that the slider 140 is no longer in contact with the yoke 118).

[0097] The electronic module 120 can have multiple power states, each power state having a corresponding power consumption level. For example, the electronic module 120 can be configured to operate in a system off state, a sleep state, and / or an active state. When the electronic module 120 is in an active state, the electronic module 120 can operate in one or more modes, such as a measurement mode, a data storage / data processing mode, an advertising mode, and / or a connection mode. It should be appreciated that the electronic module 120 can operate in multiple modes at once (e.g., the modes can overlap).

[0098] In the measurement mode, the controller of the electronic module 120 can power on the sensor system 128. The controller can enable the sensor system 128 to obtain pressure measurement readings, temperature readings, humidity readings, orientation readings, etc. for a predetermined time period (e.g., up to 60 seconds) and / or until the nozzle cover 108 is closed or no pressure change is detected. The controller can turn off one or more components of the electronic module 120 when the sensor system 128 captures the readings to further save power. The sensor system 128 can sample the readings at any suitable rate. For example, the sensor system 128 can have a sampling rate of 100Hz and therefore have a cycle time of 10 milliseconds. After the measurement cycle is completed, the sensor system 128 can generate a measurement completion interrupt. The interrupt can wake up the controller or enable 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 can process and / or store data, and if the measurement is completed, the sensor system 128 is powered off.

[0099] In some examples, the controller of the electronic module 120 can be configured to make the temperature and / or humidity sensor each perform a single measurement during the measurement mode, and can make the orientation sensor perform periodic (e.g., continuous) measurements through the measurement mode. Thus, the controller of the electronic module 120 can be configured to record signal temperature measurements and / or single humidity measurements in response to the nozzle cover 108 moving from the closed position to the open position, and in addition, the controller of the electronic module 120 can be configured to periodically (e.g., continuously) monitor the orientation of the suction device 100 in response to the nozzle cover 108 moving from the closed position to the open position.

[0100] In the data storage / data processing mode, the controller can be powered on to 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, measure or otherwise determine parameters (for example, usage and / or storage conditions) and store the parameters in the memory. The controller can also compare reading and / or parameter with one or more threshold values ​​or scopes to assess how the suction device 100 is used and / or the situation that the equipment 100 is used. According to the result of comparison, the controller can drive the indicator to provide feedback to the user of the suction device 100. As mentioned above, the electronic module 120 can operate under measurement mode and data storage / data processing mode simultaneously.

[0101] In the connected mode, the communication circuit and memory can be powered on and the electronic module 120 can be "paired" with an external device (such as a smart phone). The controller can retrieve 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 already been transmitted to the external device, and then transmit the portion(s) that have not been transmitted before. Alternatively, the external device can request specific data from the controller, such as any data collected by the electronic module 120 after a specific time or after the last transmission to the external device. If any, the controller can then retrieve the specific data from the memory and transmit the specific data to the external device.

[0102] Additionally, when connected to an external device, the electronic module 120 may be configured to transmit Bluetooth Special Interest Group (SIG) characteristics to manage access to data stored in the module 120. The Bluetooth SIG characteristics may include one or more of a manufacturer's name of the inhalation device 100, a serial number of the inhalation device 100, a hardware version 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.

[0103] After determining one or more parameters (for example, usage and / or storage condition) from the reading of sensor system 128, suction device 100 can be in connection mode to external device transmission parameter and / or associated timestamp (for example, based on internal counter).For example, the signal generated by switch 130, the measurement reading obtained by sensor system 128 can be stamped with timestamp and stored in memory.The aforementioned parameters can indicate various usage and / or storage conditions associated with suction device 100.For example, when the movement of slide 140 makes switch 130 change between " on " and " off ", the controller of electronic module 120 can use the signal from switch 130 to record each change and add timestamp to it.In addition, because switch 130 can be relevant to the position (for example, opening or closing) of nozzle cover 108 in the change between " on " and " off ", therefore electronic module 120 can be able to detect and track the position of nozzle cover 108 over time. It will be appreciated that the electronic module 120 may be able to sense and track the state of the mouthpiece cover 108 without interfering with the delivery of medicament through the flow pathway 119 of the inhalation device 100 .

[0104] Inhalation device 100 can include multiple dose counters, such as any combination of one or more mechanical dose counters and / or electrical dose counters.(One or more) mechanical dose counters and (one or more) electrical dose counters can be triggered based on different actuations or actions occurring at the inhaler so that the dose counted increases or decreases (e.g., record dosing events). As mentioned above, inhalation device 100 can include mechanical dose counters (such as dose counter 111), and the reading (e.g., count or digit) displayed by dose counter 111 can be referred to as mechanical dose reading. Mechanical dose reading can correspond to the dose count determined by mechanical dose counter 111 or determined based on mechanical dose counter 111. When each mouthpiece cover 108 is opened or each mouthpiece cover 108 is closed, dose counter 111 can advance (e.g., increase or decrease). Although the mechanical dose counter 111 is described as being actuated based on movement of the mouthpiece cover 108, in other examples, the mechanical dose counter 111 may take other forms and / or be actuated based on other actuations of the inhalation device 100 (e.g., such as pressing a button of the inhalation device 100, turning a dial, moving a lever or switch, etc., which may cause a drug to be dispensed or prepared).

[0105] Suction device can comprise electronic module 120, and it records dosage event based on the actuation (for example, the movement of mouthpiece cover 108, the actuation of internal switch etc.) of suction device for example and / or based on the feedback from sensor system 128 (for example, based on the measured value indication flow rate from sensor system 128 being higher than specific threshold value).Different sensors can be associated with corresponding criteria or threshold value for determining whether dosage event occurs.Therefore, different situations can cause the dosage event based on the data record from the first sensor, and can not cause the dosage event according to the second sensor record.When the data from sensor is sucked into the electronic module of device and / or is used to determine whether to record dosage event by the processor of external device, the dosage event recorded can be referred to as electronic dose reading.

[0106] The electronic dose reading may be a dose count or value determined based on the switch 130 being actuated (e.g., based on a signal generated in response to the switch 130 being actuated during the opening of the mouthpiece cover 108). Alternatively or additionally, the electronic dose reading may be a dose count or value determined based on interpreting or processing sensor data from a sensor present on the inhalation device 100. Examples of electronic dose reading data may include raw or processed data from one or more (or any combination thereof) of a pressure sensor, a temperature sensor, a humidity sensor, an acoustic sensor, an optical sensor, a direction sensor, and / or any other raw or processed data from any sensor of the inhalation device.

[0107] One or more electronic dose readings / electronic dose counts from one or more sensors may be compared to each other and / or to mechanical dose readings / mechanical dose counts to determine if a difference exists and / or if the difference exceeds a threshold. In an example, a first electronic dose reading from a first set of one or more sensors may be compared to a second electronic dose reading from a second set of one or more sensors to determine if a difference exists and / or if the difference exceeds a threshold.

[0108] For example, electronic module 120 may include switch 130 and one or more sensors (such as pressure sensor). Electronic module 120 may record dosage events when switch 130 is actuated at each time, which may be performed when nozzle cover 130 moves to open position from closed position. For example, when switch 130 is activated via the opening of nozzle cover 108 at each time, the signal generated by switch 130 may be counted as dosage events. Thus, with regard to dosage tracking, the number of times of the actuation of switch 130 and the number of times of advancement in dose counter 111 may produce identical (or at least similar) results. But, in some cases, the number of times of the actuation of switch 130 and the number of times of advancement of dose counter 111 may be different, for example, due to the misoperation of the user to suction device 100.

[0109] The data collected and stored by the electronic module 120 (e.g., the dosing events recorded) can also be used to estimate the number of doses delivered from the inhalation device 100 and / or estimate the number of doses remaining in the medicine reservoir 110. When the mouthpiece cover 108 was opened 60 times, the inhalation device 100 can be considered to have delivered 60 doses. The inhalation device 100 can be configured to store enough medicines in the medicine reservoir 110 to deliver a predefined total dose, such as 200 doses in total. As such, the inhalation device 100 can also be considered to have 140 doses remaining after the mouthpiece cover 108 was opened 60 times.

[0110] The electronic module 120 can count the dose each time the pressure sensor from the sensor system 128 provides a pressure measurement value higher than a threshold value (e.g., 30 liters per minute (L / min)), for example, in addition to counting the dose each time the switch 130 is actuated, or alternatively counting the dose each time the switch 130 is actuated. Each time the sensor system 128 provides a pressure measurement value higher than the threshold value, the electronic module 120 can record a dose event (e.g., store it in a memory). As described above, if the previous dose of the drug is not properly atomized and / or transferred from the dosing cup 116 by the deagglomerator 121, then when the user opens the mouthpiece cover 108, the drug may not be delivered from the drug reservoir 110. Therefore, it should be recognized that if, for example, the user opens and closes the mouthpiece cover 108 without inhaling from the mouthpiece 106, then counting the number of doses delivered based on the opening or closing of the mouthpiece cover 108 may not accurately reflect the actual number of doses delivered by the inhalation device 100.

[0111] For example, the deagglomerator 121 in the inhalation device 100 can be configured to (e.g., completely) aerosolize the drug in the dosing cup 116 when the airflow through the flow passage 119 exceeds a threshold value (such as 30 L / min). As such, each time the peak airflow measured by the sensor system 128 is above a threshold value (e.g., 30 LPM), a dose can be counted as delivered, thereby taking into account the situation where the mouthpiece cover 108 is opened but the drug in the dosing cup 116 is only partially aerosolized (or not aerosolized at all) by the deagglomerator 121.

[0112] The inhalation device 100 (e.g., a controller of the electronic module 120) and / or a mobile application residing on an external device can be configured to detect a difference between two or more dose counters (e.g., any combination of mechanical and / or electrical dose readings) of the inhalation device 100. The detected difference can be any difference in the detected dose determined using a first method of detecting a dose and a second method of detecting a dose. The inhalation device 100 and / or the external device (e.g., a mobile application) can determine the detected dose based on a reading displayed by a mechanical dose counter (e.g., dose counter 111) and / or based on a signal received from one or more sensors of the inhalation device 100 and / or based on an actuation of a switch 130. For example, the inhalation device 100 and / or the external device can be configured to detect a difference between the number of doses counted by the dose counter 111 and the number of doses counted by the electronic module 120. Alternatively or additionally, the inhalation device 100 and / or the external device may be configured to detect a difference between the number of doses counted based on signals received from two different sensors of the electronic module 120 and / or the number of doses counted based on signals received from a sensor of the electronic module 120 and based on actuation of the switch 130. The difference may be detected as a difference in the number of dose counts. For example, any number and combination of dose count detection methods may be used, and the difference between any two or more dose count detection methods may be considered a difference.

[0113] As an example, a metering event (e.g., a dose count) can be determined using an airflow metric (such as a reading from a pressure sensor). A metering event (e.g., a dose count) can be determined based on the actuation of the switch 130. A metering event (e.g., a dose count) can be determined based on feedback from another (or multiple) sensor (such as a temperature, humidity, and / or orientation sensor of the device). The controller of the electronic module 120 can be configured to track metering events each time the airflow through the flow passage 119 exceeds a threshold value (e.g., 30 LPM), each time the switch 130 is actuated, and / or based on feedback from one or more other sensors of the inhalation device 100.

[0114] Inhalation device 100 (e.g., controller of electronic module 120) and / or mobile application resident on external device can be configured to identify and provide notification (e.g., warning) about inhaler misuse or defect when the difference between the number of doses counted by two or more dose counters and / or dose reading exceeds the dose difference threshold value (e.g., 5 dose differences). For example, if the difference exceeds the dose difference threshold value, the electronic module 120 can make LED light, change color and / or flicker. Alternatively or additionally, if the difference exceeds the dose difference threshold value, the mobile application can provide notification. In addition, if the difference exceeds the dose difference threshold value, the mobile application can prompt the user to call the customer service center and / or play the video of the instructions for use of the inhalation device 100. Additionally, the inhalation device 100 (e.g., a controller of the electronic module 120) and / or a mobile application residing on an external device may be configured to recognize and provide a notification to the user regarding inhaler misuse or defect when the difference between a dosing event (e.g., based on actuation of the switch 130 or based on a mechanical dose reading) and an inhalation event (e.g., based on feedback from one or more sensors of the electronic module 120) exceeds a dose difference threshold.

[0115] For example, suction device 100 and / or the mobile application resident on the external device can provide the notification of the type specific to difference.This notification can be provided to the user, the manufacturer or the HCP of inhaler.For example, if the number of times that the difference indication user has operated the mouthpiece cover (for example, or operated another mechanical actuation component of suction device 100) is more than the number of times that the user has sucked by the suction device (for example, based on the feedback from one or more sensors of suction device 100), this notification can notify the user, the manufacturer or the HCP of inhaler so that the user does not inhale (for example, based on a plurality of low inhalation events or do not have inhalation events and do not inhale strongly enough, in this case, the notification can instruct the user how to correctly inhale) when each suction device 100 is actuated.In addition, if the number of times that the difference indication user has operated the mouthpiece cover (for example, or operated another mechanical actuation component of suction device 100) is more than the number of times that switch 130 is actuated, so notification can indicate that there is a connection fault (for example, mechanical disconnection, electrical fault, such as due to water damage etc.) between the switch 130 of dosage delivery mechanism and electronic module. If the difference indicates that the user has operated the mouthpiece cover (e.g., or has operated another mechanically actuated component of the inhalation device 100) fewer times than the electronic dose reading (e.g., based on the switch 130 being actuated and / or sensor data), then the notification may indicate that the mechanical dose counter 111 and / or dose delivery mechanism may be faulty.

[0116] More generally, there can be an expected relationship between the sensor data based on the use of the inhaler, and a difference threshold can be established between the data from two or more sensors to determine whether a difference has occurred and what the cause of the error is. Therefore, the threshold of the difference of the reading between the data from two different sensors can be specific to those two sensors. As an example, if there is a difference threshold specific to the reading from a pressure sensor and an acoustic sensor. The difference threshold specific to the reading from the pressure sensor and the acoustic sensor can be different from the difference threshold specific to the reading from the pressure sensor and the mechanical sensor. Notification can be provided based on exceeding the difference threshold specific to the sensor. Exceeding the difference threshold specific to different sensors can be interpreted as different types of events or errors. For example, the difference between the data from the pressure sensor and the acoustic sensor (for example, exceeding the first sensor-sensor threshold) can trigger a notification indicating that one or more faults have occurred in the sensor. In another example, the difference between the data from the pressure sensor and the mechanical sensor (for example, exceeding the second sensor-sensor threshold) can trigger a notification indicating that the patient has not inhaled correctly.

[0117] The inhalation device 100 may transmit (e.g., wirelessly) individual dosing events, raw sensor data, and / or the number of doses counted by the electronic module 120 to an external device (e.g., to a mobile application residing on the external device). For example, the electronic module 120 may determine one or more electronic dose readings (e.g., based on actuation of the switch 130 and / or feedback from one or more sensors), or the electronic module 120 may store dose events (based on actuation of the switch 130 and / or feedback from one or more sensors, such as when the feedback exceeds a threshold) and / or raw sensor data in a memory, and send the dosing events and / or raw sensor data to the external device, and the external device may calculate (one or more) electronic dose readings. The external device may determine a mechanical dose reading (e.g., the number of doses counted by the dose counter 111) by, for example, prompting a user or technician to manually enter the number of doses into a mobile application, by using a camera of the external device (e.g., by prompting the user to take a picture of the dose counter 111 or holding the camera over the dose counter 111), etc.

[0118] Determining when the difference between the number of doses counted by the dose counter 111 and the number of doses counted by the electronic module 120 exceeds a dose difference threshold may be useful for verifying clinical trial results, detecting abnormal patient usage, detecting device malfunctions, etc. For example, the difference may be due to a user not fully opening and / or closing the mouthpiece cover 130 before or after using the inhalation device 100. The difference may be due to, for example, a user not properly inhaling a dose of medication (e.g., not inhaling with enough force to cause the dose of medication to leave the inhalation device 100 and enter the user's lungs).

[0119] During the whole life of the inhalation device 100, the dose difference threshold value can be variable. There can be a natural mechanical error rate associated with the dose counter 111, which is determined during the life of the inhalation device 100. For example, the dose counter 111 can have an error rate of + / -5 doses during the application of all 200 doses of the drug storage 200. That is, assuming that the inhalation device 100 is correctly used, the dose counter 111 can have an error of + / -5 doses at most during the application of the complete 200 doses. Similarly, there can be an error rate associated with the airflow measurement measurement performed by the electronic module 120. Since the error rate is determined based on the application of the full capacity of the drug storage 110, the dose difference threshold value can be variable based on the number of doses remaining in the drug storage. Thereby, the dose difference threshold value can change based on the number of doses remaining in the drug storage 110.

[0120] The dose difference threshold may increase linearly or logarithmically as the estimated remaining dose in the drug reservoir 110 decreases. For example, the dose difference threshold may be a first value (e.g., 2 doses) when the electronic module 120 estimates the number of doses remaining in the drug reservoir 110 to be within a first range (e.g., between 200 and 150 doses remaining), a second value (e.g., 4 doses) when the estimated remaining dose is within a second range (between 150 and 50 doses remaining), and a third value (e.g., 5 doses) when the estimated remaining dose is within a third range (less than 50 doses remaining).

[0121] Data stored in the memory of the electronic module 120 (e.g., signals generated by the switch 130, measurement readings acquired by the sensor system 128, and / or parameters calculated by the controller of the electronic module 120) can be transmitted to an external device, which can process and analyze the data to determine usage parameters associated with the inhalation device 100. In addition, a mobile application resident on the external device can generate feedback for the user based on the data received from the electronic module 120. For example, the mobile application can generate daily, weekly, or monthly reports, provide confirmation of error events or notifications, provide instructional feedback to the user, etc.

[0122] The inhalation device 100 and / or the external device (e.g., via a mobile application resident on the external device) can be configured to provide notifications to the user based on the user's use of the inhalation device 100. For example, the inhalation device 100 and / or the external device (e.g., via a mobile application resident on the external device) can provide notifications based on bag-related events (e.g., bag-out events, bag-out time, etc.), based on differences between two or more dose counter readings detected (e.g., readings from a mechanical dose counter and an electrical dose counter), based on feedback from the sensor system 128, etc. For each event, the notification can be unique. For example, the notification can be the lighting of an LED, generating an audible output via a speaker of the inhalation device 100 or an external device, presenting a message via a mobile application, presenting an error video or instructions for use, by sending a text, email, or instant message to an external device or DHP, and / or by providing a notification to the DHP.

[0123] Fig. 9 900 is a diagram of an example system 900 including an inhalation device 100, an external device (e.g., a mobile device 902), a public and / or private network 904 (e.g., the Internet, a cloud network), a healthcare provider 906, and a third party 908 (e.g., a friend, family member, a pharmaceutical manufacturer, etc.). The mobile device 902 may include a smartphone (e.g., Smartphone, Smartphone or smartphones), personal computers, laptops, wireless capable media devices (e.g., MP3 players, gaming devices, televisions, media streaming devices (e.g., Amazon FireTV, Nexus Player, etc.), tablet devices (e.g., handheld computing devices), televisions with Wi-Fi or wireless communication capabilities, or any other suitable device supporting Internet protocols. For example, mobile device 902 can be configured to communicate via a Wi-Fi communication link, a Wi-MAX communication link, The mobile device 902 can transmit data to a healthcare provider 906 and / or one or more third parties 908 (e.g., friends, family, pharmaceutical companies, etc.) via a public and / or private network 904.

[0124] As described above, the inhalation device 100 may include communication circuitry, such as a Bluetooth radio, for transmitting data to the mobile device 902. The data may include signals generated by the switch 130, measurement readings taken by the sensor system 128, and / or parameters calculated by the controller of the electronic module 120. The inhalation device 100 may receive data from the mobile device 902, such as, for example, program instructions, operating system changes, dosage information, alarms or notifications, confirmations, and the like.

[0125] Mobile device 902 can process and analyze data to determine the use parameter associated with suction device 100.For example, mobile device 902 can process data to identify no inhalation event, low inhalation event, good inhalation event, excessive inhalation event and / or exhalation event.Mobile device 902 can also process data to identify insufficient use event, overuse event and optimal use event.Mobile device 902 can also process data to estimate delivery and / or remaining dosage number and identify error conditions, such as those associated with timestamp error flag.Mobile device 902 can include display and be used for visually presenting software of use parameter by the GUI on display.

Claims

1. A system comprising: external devices, including processors, communications circuits, and memory; as well as an inhaler comprising a mouthpiece, a medication, a mechanical dose counter, and an electronic module including a processor and communication circuitry; wherein the processor of the electronic module is configured to record the dosing event and send a signal associated with the dosing event to an external device; and The processor of the external device is configured as follows: Determine the mechanical dose reading of the mechanical dose counter; determining an electronic dosage reading based on a signal associated with the dosing event; determining that a difference between a mechanical dose reading and an electronic dose reading exceeds a threshold; as well as Notification is provided to the user, the manufacturer of the inhaler, or a healthcare provider (HCP) based on the discrepancy.

2. The system of claim 1, wherein the mechanical dose counter is configured to decrement upon actuation of the inhaler.

3. The system of claim 1, wherein the inhaler comprises a mouthpiece cover; wherein the processor of the electronic module is configured to record a dosing event when the nozzle cover moves from a closed position to an open position to expose the nozzle; as well as Wherein the mechanical dose counter is configured to decrement when the mouthpiece cover is moved from an open position to a closed position to cover the mouthpiece.

4. The system of claim 1 , wherein the inhaler further comprises a sensor configured to measure air flow through the inhaler, and wherein the processor of the electronic module is configured to record a dosing event when a measurement from the sensor indicates a flow rate that exceeds a threshold value.

5. The system of claim 1, wherein the processor of the external device is configured to prompt a user or a manufacturer's technician to input the mechanical dose reading into the external device to determine the mechanical dose reading.

6. The system of claim 1, wherein the processor of the external device is configured to use a camera of the external device to determine the mechanical dose reading.

7. The system of claim 1, wherein the processor of the external device is configured to decrement the electronic dose reading for each signal received from the electronic module associated with a dosing event.

8. The system of claim 1, wherein the processor of the electronic module is configured to determine an electronic dose reading based on the recorded dosing events and to transmit the electronic dose reading to an external device.

9. The system of claim 1, wherein the processor of the external device is configured to provide notification to the user via a mobile application resident on the external device, by illuminating one or more light emitting diodes (LEDs) of the inhaler, or by outputting an audible signal through a speaker of the inhaler or the external device.

10. The system of claim 1, wherein the inhaler further comprises a sensor configured to measure a characteristic of inhalation through the inhaler, and a switch configured to change a power state of the electronic module; wherein the processor of the electronic module is configured to record a first dosing event based on feedback from the sensor and to record a second dosing event based on actuation of the switch; Wherein the processor of the external device is configured to provide a first notification specific to a difference between a mechanical dose reading and an electronic dose reading calculated using a first dosing event, and to provide a second notification specific to a difference between the mechanical dose reading and an electronic dose reading calculated using a second dosing event.

11. The system of claim 1, wherein the drug comprises albuterol sulfate, fluticasone propionate, HFA dipropionate, or fluticasone propionate and salmeterol.

12. An inhaler comprising: The main body, including the mouthpiece and medication; a sensor configured to measure a characteristic of inhalation through the inhaler; a mechanical dose counter configured to decrement when the mouthpiece cover of the inhaler moves from an open position to a closed position to cover the mouthpiece; as well as an electronic dose counter configured to record a dosing event when the mouthpiece cover moves from a closed position to an open position so that a dose of the medicament is prepared for inhalation by a user and the mouthpiece is exposed; Wherein the inhaler is configured to determine that a difference between the mechanical dose counter and the electronic dose counter exceeds a threshold value, and to provide a notification to a user, a manufacturer of the inhaler, or a healthcare provider (HCP) based on the difference.

13. An inhaler as claimed in claim 12, wherein when the mouthpiece cover is moved from the closed position to the open position to expose the mouthpiece, a dose of medicament is transferred from the medicament reservoir to the dosing cup to prepare the dose of medicament for inhalation by the user.

14. The inhaler of claim 12, wherein the inhaler is configured to notify the user of the difference by providing a notification to the user via a mobile application resident on the external device, by illuminating one or more light emitting diodes (LEDs) of the inhaler, or by outputting an audible signal via a speaker of the inhaler or the external device.

15. The inhaler of claim 12, wherein a discrepancy between the mechanical dose counter and the electronic dose counter indicates misuse of the inhaler or a defect in the inhaler.

16. The inhaler of claim 12, wherein the drug comprises albuterol sulfate, fluticasone propionate, HFA dipropionate or fluticasone propionate and salmeterol.

17. The inhaler of claim 12, further comprising: a humidity sensor configured to measure humidity in or near the inhaler; as well as A processor is configured to send a signal indicative of humidity in or near the inhaler to an external device.

18. The inhaler of claim 12, wherein the mechanical dose counter and the electronic dose counter are configured to be triggered based on different actuations or actions occurring at the inhaler.

19. An inhaler according to claim 18, wherein the mechanical dose counter is configured to be triggered during a non-dose actuation event occurring at the inhaler, and the electronic dose counter is arranged to be triggered during a dose preparation event occurring at the inhaler.

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