Patent Application
20240115815
Drug delivery devices facilitate the delivery of medication into a patient's body via various routes of administration. Typical routes of administration include oral, topical, sublingual inhalation, injection, and the like. The devices may be used to deliver medications for the treatment various diseases, ailments, and medical conditions. Inhalers, for example, may be used to treat asthma, chronic obstructive pulmonary disease (COPD) and/or cystic fibrosis (CF). While drug delivery devices are designed to deliver an appropriate dose of medication to a patient as part of a therapeutic treatment, the effectiveness of a particular treatment may be influenced by non-physiological factors, such as the patient's adherence and compliance.
In the context of a drug therapy, adherence may refer to the degree to which a patient is following a prescribed dosing regimen. For example, if the patient's prescription calls for two doses each day, and the patient is taking two doses per day, the patient may be considered 100% adherent. If the patient is only taking one dose per day, he or she may be deemed only 50% adherent. In the latter case, the patient may not be receiving the treatment prescribed by his or her doctor, which may negatively affect the efficacy of the therapeutic treatment.
Compliance may refer to a patient's technique when using a particular drug delivery device. If the patient is using the device in a manner that is recommended by a doctor or by a manufacturer, the device is likely to deliver the desired dose of medication and the patient may be deemed compliant. However, if the device is not being used properly during drug administration, the device's ability to deliver a proper dose of medication may be compromised. As such, the patient may be deemed non-compliant. In the case of an inhalation device or inhaler, for example, the patient may need to achieve a minimum inspiratory effort to ensure a full dose of medication is delivered from the device into the patient's lungs. For some patients, such as children and the elderly, meeting the requirements for full compliance may be difficult, for example, due to physical limitations, such as limited lung function. Accordingly, like adherence, failing to achieve full compliance may reduce the effectiveness of a prescribed treatment.
A patient's ability to achieve full compliance may be further complicated by certain physical properties of the medication. For example, some respiratory medications may consist of fine particles and/or may lack any odor or taste. Thus, a patient using an inhaler may not be able to correct a non-compliant use because he or she may not be able to immediately detect or sense that medication is being inhaled and/or know whether the amount of inhaled medication complies with the prescription.
Further, many respiratory diseases, such as asthma and COPD, are life-long conditions where treatment involves the long-term administration of medicaments to manage the patients' symptoms and to decrease the risks of irreversible changes. There is currently no cure for diseases like asthma and COPD. Treatment takes two forms. First, a maintenance aspect of the treatment is intended to reduce airway inflammation and, consequently, control symptoms in the future. The maintenance therapy is typically provided by inhaled corticosteroids, alone or in combination with long-acting bronchodilators and/or muscarinic antagonists. Secondly, there is also a rescue (or reliever) aspect of the therapy, where patients are given rapid-acting bronchodilators to relieve acute episodes of wheezing, coughing, chest tightness and shortness of breath.
Sufferers of respiratory diseases may thus be prescribed more than one medication, such as more than one inhaled medication, for controlling their symptoms. The sufferer may alternatively or additionally make use of a plurality of inhalers, each being used at different times/locations, which all deliver the same inhaled medicament. There is a growing desire to monitor administration of such medicaments in ways which are reliable, and convenient from the point of view of the sufferer. Further, such monitoring is also desirable for the patient's health care provider, who requires a simple and cohesive manner to assess each patient's adherence and compliance, and view data that indicates the highest risk of exacerbation or indicates that the patient's treatment regimen should be altered.
Systems may be designed to monitor a patient's adherence to a prescribed dosing regimen. For example, systems may be designed to monitor a patient's adherence by detecting administrations of a medicament by the patient and confirm that the patient is conforming to the prescribed dosing regimen. In order to detect administrations of the medicament, certain components may be added to or included in the drug delivery device used to administer the medicament. For example, components may be added to detect events or actuations at the drug delivery device that are indicative of an administration of the medicament by the drug delivery device. In addition, communication components may be added to the drug delivery device so that certain information associated with a respective administration of medicament by the drug delivery device (e.g., time of administration, number of remaining doses, etc.) can be transmitted to and subsequently stored at and/or analyzed by one or more external devices. Often, these components are add-on components, such as after-market processing and/or communication components that can be attached to a drug delivery device.
However, while these systems may be used to detect and monitor administrations of a drug delivery device and, by extension, measure a patient's adherence to (e.g., the degree to which a patient is following) a prescribed dosing regimen, they fail to measure or monitor the patient's compliance (e.g., the patient's technique when using a particular drug delivery device). For example, while these systems may detect and monitor administrations of medicament by the drug delivery device, they fail to measure the inhalation parameters (e.g., PIF, volume, etc.) associated with each administration event. That is, although these systems may be capable of monitoring a patient's adherence to a prescribed dosing regimen, they fail to measure inhalation parameters and thus lack any insight into a patient's compliance. In failing to measure inhalation parameters, these systems fail to appreciate the effectiveness of each inhalation.
An inhaler may include a housing that comprises a mouthpiece, a medication canister, and an airflow channel formed between an air inlet and the mouthpiece. The inhaler may also include a sensor configured to measure a parameter indicative of air flow through the airflow channel of the inhaler. The sensor may be a pressure sensor configured to measure pressure, and/or an acoustic sensor configured to measure acoustic sound waves. Although primarily described as including a pressure sensor, the inhaler described herein may be similarly configured with an acoustic sensor or a flow sensor. The pressure sensor may be a differential pressure sensor or a barometric pressure sensor. The pressure sensor may be attached to the medicament canister of the inhaler. The pressure sensor may be configured to be in a first position relative to the airflow channel when the medication canister is not actuated, and in a second position relative to the airflow channel when the medication canister is in an actuated position. Accordingly, for a predetermined airflow in the airflow channel, the pressure sensor may be configured to measure a first pressure when it is in the first position, and measure a distinguishable second pressure when it is in the second position. The medication canister may be configured to be in a first position when the medication canister is not actuated, and be in a second position when the medication canister is actuated to dispense medication. In some examples, the processor may be configured with a first flow rate calibration curve for when the pressure sensor is in the first position, and a second flow rate calibration curve for when the pressure sensor is in the second position. However, in other examples, the processor and pressure sensor may be calibrated based on only one of the first position or the second position (e.g., configured with only one of the first or second calibration curves). Further, in some examples, the inhaler may include an acoustic sensor instead of a pressure sensor.
Further, in some examples, the housing may also include a hollow socket that is configured to receive a valve stem of the medication canister. In such examples, the pressure sensor may be configured move relative to the hollow socket in response to the medication canister moving to dispense medication.
The inhaler may also include a processor. The processor may be configured to receive pressure measurements from the pressure sensor, and to determine the position of the pressure sensor or the medication canister based on the pressure measurements received from the pressure sensor while the user is inhalation through the mouthpiece of the inhaler. Further, the processor may be configured to determine (e.g., detect) whether an inhalation occurs prior the medication canister being depressed to release medication based on the pressure measurements. The processor may be configured to determine one or more flow rates based on the pressure measurements. As such, the thresholds described herein may be absolute value or slope pressure thresholds or absolute value or slope flow rate thresholds.
The processor may be configured to detect an inhalation event based on the pressure measurements received from the pressure sensor exceeding an inhalation threshold. The processor may be configured to detect a canister actuation event based on the pressure measurements exceeding a canister actuation threshold. The canister actuation threshold may be a slope threshold. The canister actuation threshold may be a larger threshold (e.g., larger, negative threshold) than the inhalation threshold. The processor may be configured to generate an error event based on a slope of the received pressure measurements not exceed a slope threshold that is indicative of the canister actuation during an inhalation. The processor may be configured to generate a late inhalation error event based on the detection of an inhalation that occurs after the medication canister is depressed. The processor may be configured to generate a late actuation error event (e.g., an early inhalation error event) based on the pressure measurements exceeding a threshold for a period of time that exceeds a duration threshold prior to the detection of the canister being actuated. For example, the processor may be configured to determine a peak inspiratory flow (PIF) based on the received pressure measurements, and generate a late actuation error event based on the PIF exceeding a threshold prior to the detection of the canister being actuated. The processor may be configured to generate a good inhalation event based on a slope of the received pressure measurements exceeding a slope threshold that is indicative of the canister actuation during an inhalation. The processor may be configured to generate an on-time inhalation event if the user's inhalation occurred within a predetermined time period before the canister was actuated (e.g., within 300-800 milliseconds before canister actuation).
The processor may be configured to generate one or more parameters (e.g., flow rates, PIF, inhalation volume, inhalation duration, etc.) based on the pressure measurements. For example, the processor may be configured to detect a duration of an inhalation event based on the pressure measurements received from the pressure sensor. The duration of the inhalation event may start at the time of the pressure measurements exceed an inhalation threshold (e.g., a slope that is indicative of an inhalation) and end when the parameters return to a predetermined value (e.g., a value indicative of the end of the user's inhalation, such as back to 0 LPM or the atmospheric pressure). Alternatively, the duration of the inhalation event may start at the time of the canister actuation event and end when the parameters return to a predetermined value. The processor is configured to detect the movement of the canister back to the first position upon the release of the canister based on a slope in the pressure measurements exceeding a canister released threshold (e.g., based on a positive change in the slope of the pressure measurements exceeding the canister release threshold).
The inhaler may notify the user of one or more events and/or parameters. For example, the inhaler may include an indicator (e.g., a speaker, display, light, etc.) that is activated to provide feedback to the user based on the detected event type. Alternatively or additionally, the inhaler may also include a transmitter configured to send data to an external device for display via a user interface of the external device. The data may include any combination of the pressure measurements, events (e.g., an inhalation event, a canister actuation event, a late, early, and on-time canister actuation events, etc.), and/or parameters that are determined based on the pressure measurements (e.g., flow rates, PIF, inhalation volume, inhalation duration, etc.). Further, in some examples, the inhaler may include a receiver configured to receive data (e.g., the inhalation threshold or the canister actuation threshold) from the external device.
The pressure sensor may include a pressure port. The pressure port may be aligned with an opening between the medication canister and the housing when the pressure sensor is connected to the medication canister. In some examples, the pressure sensor (e.g., and pressure port) is configured such that it does not extend into the inhaler housing when the pressure sensor is in the first position or the second position. For example, a gap (e.g., physical space comprising ambient air) may exist between the pressure sensor (e.g., and pressure port) and the flow channel of the inhaler when the pressure sensor is in the first position or is in the second position.
In some examples, the inhaler may include one or more additional sensors (e.g., an orientation sensor, acoustic sensor, temperature sensor, mechanical switch, etc.). The processor may be configured to detect a shake event of the inhaler based on the pressure measurements received from the pressure sensor. The inhaler may include an orientation sensor configured to detect an orientation of the inhaler, and the processor may be configured to receive data from the orientation sensor and determine an orientation of the inhaler during an inhalation event. The processor may be configured to wake or turn on the pressure sensor in response to the reception of data from one or more different sensors, based on a mouthpiece cover of the inhaler being opened, and/or based on a switch on the inhaler being actuated.
In some examples, the inhaler may include a capillary tube connected to a sensor port of the pressure sensor, where the capillary tube is configured to extend from the pressure sensor into the housing.
Further, in some examples, the inhaler may be part of a system that includes the inhaler and an external device that is configured to receive data from the inhaler and provide feedback to the user (e.g., via a display device of the external device) that indicates the detected events.
Finally, although described with reference to an inhaler, in some examples, the processor, pressure sensor, transmitter, memory, and power supply may be part of an accessory that is configured to be removably and replaceably attached to the inhaler. For examples, the accessory may be an electro-mechanical device that is configured to attached to an inhaler housing and/or a medication canister of an inhaler, and then later removed from the inhaler when, for example, the inhaler expires or is empty. An accessory would require additional user operation to physically attached the accessory to the inhaler, but would allow the accessory to be reused with multiple inhalers, thereby extending the useful life of the internal components.
With MDIs, for example, the timing between the user's inhalation and the actuation of the canister to release medicament can affect the amount of medicament that the user receives and how deep in the lungs the medicament is delivered. There is a need for a simple, accurate, and low costs inhaler or inhaler accessory that can provide an indication of the relative timing between the user's inhalation and the actuation of the medicament canister. For example, the user tends to receive a greater, and proper dose of medicament when the user inhales prior to actuating the canister. Existing inhalers may attempt to determine the relative timing of the user inhalation and the canister actuation, but these inhalers use multiple distinct sensors, where one sensor tracks the actuation of the canister and a second sensor detects the user's inhalation. But the use of two sensors can result in less accurate feedback, have increased production costs, and have additional points of failure. The devices described herein are configured to determine how well a user is inhaling and the relative timing between the user's inhalation and the canister actuation using one sensor (e.g., a single pressure or acoustic sensor).
As noted, the timing between the user inhalation and canister actuation not only affects the amount of medicament that the user receives, but is also affects how deep in the lungs the medicament is delivered. Some active pharmaceutical ingredients are used to target specific portions of the user's respiratory track, and as such, it is desirable to deliver a maximum amount of each dose to that targeted portion of the user's respiratory track. For example, some medications may target the upper airways/respiratory track of the user, while others might target the lower airways/respiratory track of the user. In such instances, the inhaler described herein may be configured to generate the canister actuation notification during the user's inhalation (e.g., based on inhaled volume and/or duration) to alert the user to actuate the canister to deliver a dose of medicament at a time that will increase the amount of the dose that is delivered to the targeted portion of the user's respiratory track. For instance, the inhaler may receive pressure measurements from a pressure sensor, determine one or more inhalation parameters based on the pressure measurements (e.g., inhaled volume and/or inhalation duration), and then generate the canister actuation notification when the inhalation parameter reaches a particular threshold. The threshold may be dependent on the portion of the user's respiratory track that is targeted by the medicament of the inhaler. For example, when the medicament is used to target the upper airways, the notification may be generated later during the inhalation (e.g., based on an inhalation parameter having a larger value) to ensure that a greater portion of the medication is provided to the upper airways, and less is delivered to the lower airways of the user. When the medicament is used to target the lower airways, the notification may be generated earlier during the inhalation (e.g., based on an inhalation parameter having a smaller value) to ensure that a greater portion of the medication is provided to the lower airways of the user.
It should be understood that the detailed description and specific examples, while indicating exemplary embodiments of the apparatus, systems and methods, are intended for purposes of illustration only and are not intended to limit the scope of the invention. These and other features, aspects, and advantages of the apparatus, systems and methods of the present invention will become better understood from the following description, appended claims, and accompanying drawings. It should be understood that the Figures are merely schematic and are not drawn to scale. It should also be understood that the same reference numerals are used throughout the figures to indicate the same or similar parts.
The present disclosure describes devices, systems and methods for sensing, tracking processing, and/or presenting usage conditions and parameters associated with a drug delivery device, such as an inhaler. The devices, systems and methods are described in the context of a metered-dose inhaler (MDI) (e.g., also referred to herein as an inhaler) for delivering medication into a user's lungs. However, the described solutions are equally applicable to other drug delivery devices, such as an injector, a dry-powder inhaler, a nebulizer, a transdermal patch, or an implantable.
Asthma and COPD are chronic inflammatory disease of the airways. They are both characterized by variable and recurring symptoms of airflow obstruction and bronchospasm. The symptoms include episodes of wheezing, coughing, chest tightness and shortness of breath.
The symptoms are managed by avoiding triggers and by the use of medicaments, particularly inhaled medicaments. The medicaments include inhaled corticosteroids (ICSs) and bronchodilators.
Inhaled corticosteroids (ICSs) are steroid hormones used in the long-term control of respiratory disorders. They function by reducing the airway inflammation. Examples include budesonide, beclomethasone (dipropionate), fluticasone (propionate or furoate), mometasone (furoate), ciclesonide and dexamethasone (sodium). Parentheses indicate preferred salt or ester forms. Particular mention should be made of budesonide, beclomethasone and fluticasone, especially budesonide, beclomethasone dipropionate, fluticasone propionate and fluticasone furoate.
Different classes of bronchodilators target different receptors in the airways. Two commonly used classes are β2-agonists and anticholinergics.
β2-Adrenergic agonists (or “(β2-agonists”) act upon the β2-adrenoceptors which induces smooth muscle relaxation, resulting in dilation of the bronchial passages. They tend to be categorized by duration of action. Examples of long-acting β2-agonists (LABAs) include formoterol (fumarate), salmeterol (xinafoate), indacaterol (maleate), bambuterol (hydrochloride), clenbuterol (hydrochloride), olodaterol (hydrochloride), carmoterol (hydrochloride), tulobuterol (hydrochloride) and vilanterol (triphenylacetate). Examples of short-acting β2-agonists (SABA) are albuterol (sulfate) and terbutaline (sulfate). Particular mention should be made of formoterol, salmeterol, indacaterol and vilanterol, especially formoterol fumarate, salmeterol xinafoate, indacaterol maleate and vilanterol triphenylacetate.
Typically short-acting bronchodilators provide a rapid relief from acute bronchoconstriction (and are often called “rescue” or “reliever” medicines), whereas long-acting bronchodilators help control and prevent longer-term symptoms. However, some rapid-onset long-acting bronchodilators may be used as rescue medicines, such as formoterol (fumarate). Thus, a rescue medicine provides relief from acute bronchoconstriction. The rescue medicine is taken as-needed/prn (pro re nata). The rescue medicine may also be in the form of a combination product, e.g. ICS-formoterol (fumarate), typically budesonide-formoterol (fumarate) or beclomethasone (dipropionate)-formoterol (fumarate). Thus, the rescue medicine is preferably a SABA or a rapid-acting LABA, more preferably albuterol (sulfate) or formoterol (fumarate), and most preferably albuterol (sulfate).
Anticholinergics (or “antimuscarinics”) block the neurotransmitter acetylcholine by selectively blocking its receptor in nerve cells. On topical application, anticholinergics act predominantly on the M3 muscarinic receptors located in the airways to produce smooth muscle relaxation, thus producing a bronchodilatory effect. Examples of long-acting muscarinic antagonists (LAMAs) include tiotropium (bromide), oxitropium (bromide), aclidinium (bromide), umeclidinium (bromide), ipratropium (bromide) glycopyrronium (bromide), oxybutynin (hydrochloride or hydrobromide), tolterodine (tartrate), trospium (chloride), solifenacin (succinate), fesoterodine (fumarate) and darifenacin (hydrobromide). Particular mention should be made of tiotropium, aclidinium, umeclidinium and glycopyrronium, especially tiotropium bromide, aclidinium bromide, umeclidinium bromide and glycopyrronium bromide.
A number of approaches have been taken in preparing and formulating these medicaments for delivery by inhalation, such as via a dry powder inhaler (DPI), a pressurized metered dose inhaler (pMDI) or a nebulizer.
According to the GINA (Global Initiative for Asthma) Guidelines, a step-wise approach is taken to the treatment of asthma. At step 1, which represents a mild form of asthma, the patient is given an as needed SABA, such as albuterol sulfate. The patient may also be given an as-needed low-dose ICS-formoterol, or a low-dose ICS whenever the SABA is taken. At step 2, a regular low-dose ICS is given alongside the SABA, or an as-needed low-dose ICS-formoterol. At step 3, a LABA is added. At step 4, the doses are increased and at step 5, further add-on treatments are included such as an anticholinergic or a low-dose oral corticosteroid. Thus, the respective steps may be regarded as treatment regimens, which regimens are each configured according to the degree of acute severity of the respiratory disease.
COPD is a leading cause of death worldwide. It is a heterogeneous long-term disease comprising chronic bronchitis, emphysema and also involving the small airways. The pathological changes occurring in patients with COPD are predominantly localized to the airways, lung parenchyma and pulmonary vasculature. Phenotypically, these changes reduce the healthy ability of the lungs to absorb and expel gases.
Bronchitis is characterized by long-term inflammation of the bronchi. Common symptoms may include wheezing, shortness of breath, cough and expectoration of sputum, all of which are highly uncomfortable and detrimental to the patient's quality of life. Emphysema is also related to long-term bronchial inflammation, wherein the inflammatory response results in a breakdown of lung tissue and progressive narrowing of the airways. In time, the lung tissue loses its natural elasticity and becomes enlarged. As such, the efficacy with which gases are exchanged is reduced and respired air is often trapped within the lung. This results in localized hypoxia, and reduces the volume of oxygen being delivered into the patient's bloodstream, per inhalation. Patients therefore experience shortness of breath and instances of breathing difficulty.
Patients living with COPD experience a variety, if not all, of these symptoms on a daily basis. Their severity will be determined by a range of factors but most commonly will be correlated to the progression of the disease. These symptoms, independent of their severity, are indicative of stable COPD and this disease state is maintained and managed through the administration of a variety drugs. The treatments are variable, but often include inhaled bronchodilators, anticholinergic agents, long-acting and short-acting β2-agonists and corticosteroids. The medicaments are often administered as a single therapy or as combination treatments.
Patients are categorized by the severity of their COPD using categories defined in the GOLD Guidelines (Global Initiative for Chronic Obstructive Lung Disease, Inc.). The categories are labelled A-D and the recommended first choice of treatment varies by category. Patient group A are recommended a short-acting muscarinic antagonist (SAMA) prn or a short-acting β2-aginist (SABA) prn. Patient group B are recommended a long-acting muscarinic antagonist (LAMA) or a long-acting β2-aginist (LABA). Patient group C are recommended an inhaled corticosteroid (ICS)+a LABA, or a LAMA. Patient group D are recommended an ICS+a LABA and/or a LAMA.
Patients suffering from respiratory diseases like asthma or COPD suffer from periodic exacerbations beyond the baseline day-to-day variations in their condition. An exacerbation is an acute worsening of respiratory symptoms that require additional therapy, i.e. a therapy going beyond their maintenance therapy.
For asthma, the additional therapy for a moderate exacerbation are repeated doses of SABA, oral corticosteroids and/or controlled flow oxygen (the latter of which requires hospitalization). A severe exacerbation adds an anticholinergic (typically ipratropium bromide), nebulized SABA or IV magnesium sulfate.
For COPD, the additional therapy for a moderate exacerbation are repeated doses of SABA, oral corticosteroids and/or antibiotics. A severe exacerbation adds controlled flow oxygen and/or respiratory support (both of which require hospitalization). An exacerbation within the meaning of the present disclosure includes both moderate and severe exacerbations.
Each usage event may include one or more usage parameters that are determined by the use determination system 12. Usage parameters may include any number of parameters indicative of a usage event at the inhaler 100 by a user. For example, usage parameters may include the duration of the shaking of the inhaler 100, the orientation of the inhaler 100 during an inhalation, the coordination of the actuation of a medication canister of the inhaler with an inhalation by a user, the temperature or humidity of the inhaler during an inhalation, and/or any combination of inhalation parameters (e.g., flow rate, duration, etc.) that are measured during an inhalation event. The usage parameters may be measured by the use determination system 12, for example, in response to detecting a given usage event. Specifically, and as further described herein, the use determination system 10 may measure one or more inhalation specific usage parameters in response to detecting an inhalation event. The usage parameters measured by the use determination system 12 for an inhalation event, also referred to herein as inhalation parameter(s) (e.g., as the relevant device is an inhaler), may include one or more of: a peak inspiratory/inhalation flow (PIF), an inhalation volume, a time to peak inhalation flow, and/or an inhalation duration.
The inhaler 100 may include a transmission module 14. The transmission module 14 may receive the usage parameter(s), as represented in
Although examples described herein may refer to a transceiver, the transceiver may be configured to transmit, but not receive, data (e.g., a transmitter but not a receiver). The transceiver may include one or more semiconductor chips, integrated circuits, and/or the like configured to implement the logic and procedures of the communication protocol. The transceiver may include radio frequency (RF) hardware such as amplifier(s), oscillator(s), modulator circuit(s), antenna(s), antenna tuner(s), and/or the like in order to transmit signals wirelessly using the communication protocol. The RF hardware may be implemented in whole or in part on the semiconductor chip(s), integrated circuit(s), and/or the like configured to implement the logic and procedures of the communication protocol.
In some examples, the transmission module 14 is configured to transmit and/or receive data via Bluetooth®. Bluetooth® may be used because the relatively low energy associated with transmitting and receiving may preserve the battery life of the respective inhaler. Moreover, no internet connection need be established in order for the respective encrypted data to be transmitted.
The use determination system 12 may comprise a suitable processor, memory, and power source (e.g., battery) configured to perform the functions described herein for the processing module. For example, the processor may be a general purpose processor programmed with computer executable instructions for implementing the functions of the use determination system 12. The processor may be implemented using a microprocessor or microcontroller configured to perform the functions of the use determination system 12. The processor may be implemented using an embedded processor or digital signal processor configured to perform the functions of the use determination system 12.
As described herein, a usage parameter may, for example, comprise an indication of a use of the respective inhaler. In a relatively simple implementation, the at least one value may indicate whether a usage event has been detected by the use determination system 12 and comprise “TRUE” when use of, for example an inhalation using, the inhaler 100 has been determined, or “FALSE” when no such use of the inhaler 100 is determined.
The use determination system 12 may include one or more of a switch configured to detect usage of inhaler 100, one or more sensors configured to detect use of inhaler 100, one or more buttons configured to be depressed upon use of inhaler 100, and/or the like. As such, a usage parameter may be one or more measurements performed by the use determination system, such as a count of the number of uses inhaler 100, a measure of airflow of inhaler 100, a detection of the canister of the inhaler 100 being actuated, and/or another measurement indicating the usage of the medicament of inhaler 100. The use determination system 12 may register each inhalation in different manners and/or based on additional or alternative feedback. For example, the use determination system 12 may be configured to register an inhalation by the user when the feedback from a suitable sensor indicates that an inhalation by the user has occurred, for example when a pressure measurement or flow rate exceeds a predefined threshold associated with a successful inhalation, when a medication canister of the inhaler is actuated, etc.
More generally, the use determination system 12 may comprise a sensor for detecting a parameter relating to airflow during inhalation of the respective medicament performed by the user. In other words, the usage parameter may comprise a parameter relating to airflow during inhalation of the medicament. The at least one value may thus, for example, comprise a numerical value relating to the detected inhalation parameter.
The sensor(s) of the use determination system 12 may include any combination of a pressure sensor, an acoustic sensor, a flow sensor, an accelerometer, and/or a touch sensitive device (e.g., a capacitive touch sensitive circuit with capacitive touch sensitive pads). Such a sensor may be an alternative to or in addition to the abovementioned mechanical switch. The pressure sensor may be a differential pressure sensor or a barometric/absolute pressure sensor.
The use determination system 12 may use feedback from a sensor, such as an accelerometer and/or touch sensitive device to change power states. For example, the use determination system 12 may reside in a low power state, such as an off state or a sleep state, when not in use. During the low power state, any combination of sensors, the transmission module 14, and/or various pins on the processor may be off (e.g., other than the sensor and associated pin on the processor that is used to trigger the use determination system 12 to switch power states). The use determination system 12 may switch from the low power state to an on state in response to receiving feedback from a sensor, such as feedback from an accelerometer that indicates that the user is shaking the inhaler (e.g., an MDI inhaler) or feedback from a touch sensitive device that indicates that the user has the inhaler in their hand, for example. The use determination system 12 may turn on the transmission module 14 and/or the pressure sensor, and/or begin receiving measurements from the pressure sensor in response to switching from a low power state, such as an off state or a sleep state, to an on state.
The use determination system 12 may receive pressure measurements from a pressure sensor, and may calculate one or more inhalation parameters based on the pressure measurements. The inhalation parameter may be, for example, at least one of flow rate, a PIF, an inhalation volume, a time to peak inhalation flow, and/or an inhalation duration. As detailed further herein, the use determination system 12 may use the inhalation parameter to classify a respective usage event and/or inhalation event (e.g., a good inhalation event, a fair inhalation event, a low/no inhalation event, an exhalation event, a possible air vent block event, etc.). Further, in some examples, the use determination system 12 may determine and store a flow profile (e.g., a series of consecutive pressure measurements) associated with a usage event. As described herein, these inhalation parameters may be used to assess the user's compliance, which may provide valuable insight into the state of the user's respiratory disease (e.g., the likelihood that the patient is to experience an exacerbation event) and/or the patient's sensitivity to current or changing environmental conditions (e.g., heat, air quality, humidity, etc.). Further, the use determination system 12 may timestamp and/or geotag the usage event, error event, and/or usage parameters (e.g., using a real-time stamp or a relative time stamp that begins when the user first operates the inhaler).
A pressure sensor may be particularly suitable for measuring the parameter, since the airflow during inhalation by the user may be monitored by measuring the associated pressure changes. The pressure sensor may be located external to a flow pathway through which air and the medicament is drawn by the user during inhalation. An inhalation may be associated with a decrease in the pressure in the airflow channel of the inhaler relative to when no inhalation is taking place. The point at which the pressure change is at its greatest may correspond to the peak inhalation flow. The pressure sensor may detect this point in the inhalation. Alternative ways of measuring the parameter, such as via a suitable flow sensor, can also be used.
The pressure change associated with an inhalation may alternatively or additionally be used to determine an inhalation volume. This may be achieved by, for example, using the pressure change during the inhalation measured by the pressure sensor to first determine the flow rate over the time of the inhalation, from which the total inhaled volume may be derived.
The pressure change associated with an inhalation may alternatively or additionally be used to determine an inhalation duration. The time may be recorded, for example, from the first decrease in pressure measured by the pressure sensor, coinciding with the start of the inhalation, to the pressure returning to a pressure corresponding to no inhalation taking place.
The inhalation parameter may alternatively or additionally include the time to peak inhalation flow. This time to peak inhalation flow parameter may be recorded, for example, from the first decrease in pressure measured by the pressure sensor, coinciding with the start of the inhalation, to the pressure reaching a minimum value corresponding to peak flow.
Further, in some examples, the inhalation parameter may be a flow profile that includes a plurality of measurements from the pressure sensor taken over time (e.g., which may include one or more of a peak inhalation flow, an inhalation volume, a time to peak inhalation flow, and/or an inhalation duration). For example, the use determination system 12 may turn on the pressure sensor and/or begin receiving measurements from the pressure sensor in response to switching from a low power state, such as an off state or a sleep state, to an on state. The use determination system 12 may determine (e.g., calculate) a flow profile using the received pressure measurements.
The use determination system 12 may compare the measurements received from the pressure sensor (e.g., the flow profile) to one or more thresholds and determine whether the measurements are indicative of an inhalation by the user. For instance, the use determination system 12 may determine that the measurements are indicative of an inhalation by the user when a pressure measurement exceeds a predetermined value or is within a predetermine range that is indicative of peak inhalation by a user, the pressure measurements indicate a slope that is indicative of inhalation (e.g., there is a change in pressure over time that is indicative of inhalation), the pressure measurements indicate an inhalation duration that is within a predetermined time range, and/or the like. After determining that the measurements are indicative of an inhalation by the user, the use determination system 12 may store a plurality of the measurements received from the pressure sensor as a flow profile associated with the inhalation event.
Further, in some examples, the use determination system 12 may include a sensor, and the use determination system 12 may be configured to determine the position of the sensor and/or the medication canister of the inhaler 100 while the user inhales through the inhaler 100. The use determination system 12 may be configured to detect whether an inhalation by a user through the inhaler 100 occurs prior a medication canister of the inhaler 100 being depressed to release medication based on measurements received from the sensor (e.g., pressure measurements from a pressure sensor, acoustic measurements from an acoustic sensor, or flow measurements from a flow sensor). For example, the pressure sensor (e.g., or a sensor port of the pressure sensor) may be attached to or moveable in relation to any movement of the medication canister. Further, the inhaler 100 may include an airflow channel that, for example, resides between a mouthpiece of the inhaler and an air inlet of the inhaler. As such, when the canister is depressed either by the user's actuation or inhalation (e.g., in the case of a breath actuated MDI), the pressure sensor and/or sensor port of the pressure sensor is configured to move relative to the flow channel of the inhaler 100. Accordingly, (e.g., while a user is inhaling through the inhaler 100) the pressure sensor may be configured to measure a first pressure when the pressure sensor is in the first position (e.g., prior to canister actuation) relative to the flow channel of the inhaler 100, and a distinguishable second pressure when the canister is in the second position (e.g., a depressed position to release a dose of medication) relative to the flow channel of the inhaler 100. The use determination system 12 may determine that the canister moved positions when the pressure measurements exceed a slope threshold.
For instance, as described in more detail herein, while the user is inhaling through the inhaler 100, the pressure measurements may change by a distinguishable amount (e.g., a step, such as shown in the examples of
In some examples, the pressure sensor is configured such that it does not extend into the inhaler housing when the pressure sensor is in the first position and/or the second position. For example, the pressure sensor may be configured such that a gap exists between the pressure sensor (e.g., and pressure sensor port) and the flow channel of the inhaler when the pressure sensor is in the first position and/or the second position. The pressure sensor may include a sensor port that is aligned with an opening between the medication canister and the inhaler housing when the pressure sensor is connected to the medication canister. However, in some examples, the sensor port does not extend into or between the inhaler housing and the canister. Further, in some examples, the pressure sensor may be pneumatically coupled to the flow channel, but the pneumatic coupling may be rather weak (e.g., due to the gap between the sensor port and the inhaler housing). For example, the pressure sensor may not be in an airtight or substantially airtight configuration with respect to the flow channel. Since, in some examples, the pressure sensor may be weakly pneumatically coupled to the flow channel of the inhaler 100, the pressure measurements may change by a distinguishable amount when the relative position of the pressure sensor to the flow channel changes upon actuation of the canister.
The use determination system 12 and/or the pressure sensor may be configured with a first flow rate calibration curve for when the pressure sensor is in the first position, and a second flow rate calibration curve for when the pressure sensor is in the second position. Further, in some examples, the use determination system 12 and/or the pressure sensor is calibrated based on only one of the first position or the second position (e.g., which may ensure the distinguishable change in pressure measurements when the pressure sensor changes position relative to the flow channel).
The use determination system 12 may be configured to compare the received pressure measurements (e.g., or one or more inhalation parameters calculated using the received pressure measurements) to one or more thresholds to determine one or more events. For example, the use determination system 12 may be configured to compare the pressure measurements to an inhalation threshold, and determine (e.g., generate) an inhalation event based on the pressure measurements exceeding the inhalation threshold. The inhalation threshold may be an absolute pressure value, a rate of change of the pressure measurements (e.g., a slope threshold), and/or the like. The use determination system 12 may be configured to compare the pressure measurements to a canister actuation threshold, and determine (e.g., generate) a canister actuation event based on the pressure measurements exceeding the canister actuation threshold. The canister actuation threshold may be a rate of change of the pressure measurements (e.g., a slope threshold), or an absolute value. The canister actuation threshold may be larger than the inhalation event (e.g., a greater rate of change, or slope threshold, or a larger absolute negative pressure value), for example since the actuation of the canister may bring the pressure sensor closer to the flow channel.
The use determination system 12 may be configured to compare the pressure measurements to a canister released threshold, and detect the movement of the canister back to the first position based on the pressure measurements falling exceeding a canister release threshold. For example, the canister release threshold may be slope threshold that indicates a positive rate of change of the pressure measurements that indicates that the canister has moved back to the unactuated position, or may be an absolute pressure value. The use determination system 12 may generate a canister released event when the rate of change of the pressure measurements exceeds the canister release threshold. The use determination system 12 may be configured to determine a duration of an inhalation event based on the amount of time that the pressure measurements (e.g., flow rates) exceed the inhalation threshold. Alternatively, the duration of the inhalation event may start at the time of the canister actuation event and ends when the flow rates fall below the inhalation threshold.
The use determination system 12 may be configured to generate one or more error events based on feedback from the pressure sensor. For example, the use determination system 12 may be configured to generate a late inhalation error event when the detection of an inhalation occurs after the medication canister is depressed. Alternatively or additionally, the use determination system 12 may be configured to generate a late actuation error event when the pressure measurements (e.g., flow rates) exceed a threshold for a period of time that exceeds a duration threshold prior to the detection of the canister being actuated. For example, the use determination system 12 may determine that the user inhales for too long of a period of time prior to the canister being actuated, and in response, generate the late actuation error event. The inhaler may generate an on-time inhalation event if the user's inhalation occurred within a predetermined time period before the canister was actuated. The use determination system 12 may be configured to send the error events, via transmission module 14, to an external device for display via a user interface of the external device (e.g., a smartphone, tablet, PC, etc.). Alternatively or additionally, the use determination system 12 may send the pressure measurements to the external device, and the external device may generate any combination of the events described herein (e.g., the inhalation event, the canister actuation event, the canister released event, any of the error events), for example, and display an indication of the error event on the user interface of the external device. Further, the use determination system 12 and/or the external device may timestamp and/or geotag the events and/or usage parameters (e.g., using a real-time stamp or a relative time stamp that begins when the user first operates the inhaler).
Further, in some examples, the use determination system 12 may be configured to generate a canister actuation notification to indicate to the user when to actuate the canister. The inhaler 100 may include an indicator, such as a light, speaker, a display, a vibrating element, etc., that is configured to generate a notification or provide feedback to the user. The use determination system 12 may be configured to calculate inhalation volume and/or inhalation duration based on the received pressure measurement. The use determination system 12 may determine when the pressure measurements (e.g., flow rates) indicate that the inhaled volume and/or duration of an inhalation exceed a canister notification threshold, and in response, generate the canister actuation notification via the indicator to indicate to the user to actuate the canister. As such, the use determination system 12 may be configured to alert the user when to actuate the canister to assist the user in receiving the proper amount of medication and/or to assist in ensuring delivery of the medication to the proper portion of the respiratory system (e.g., the upper airways/respiratory track or the lower airways/respiratory track). The canister notification threshold may be based on the portion of the user's respiratory track that is targeted by the medicament of the inhaler 100. In some instances, the active pharmaceutical ingredient of the medication may be used to target the upper airways of the user. In such instances, the use determination system 12 may be configured to generate the canister actuation notification at a time during the user's inhalation (e.g., based on inhaled volume and/or duration) to ensure that the active pharmaceutical ingredient of the medication is delivered to the upper airways of the user. For example, the notification may be generated later than normal during the inhalation to ensure that a greater portion of the medication is provided to the upper airways, and less is delivered to the lower airways of the user.
As noted above, the use determination system 12 may be configured to detect a user's exhalation through the inhaler 100. Further, the use determination system 12 may be configured to detect the duration of time that a user holds their breath based on measurements received from the sensor (e.g., the pressure sensor or acoustic sensor). For example, the use determination system 12 may detect the beginning of the user's inhalation when the received pressure measurements exceed an inhalation threshold (e.g., a slope in pressure measurements that is indicative of a user's inhalation), and detect when the user stops inhaling (e.g., has inhaled completely) based on the received pressure measurements (e.g., when the pressure measurements return to or fall below a particular value). The use determination system 12 may detect when the user exhales their breath based on received pressure measurement assuming, for example, that the user exhales through the inhaler 100. The use determination system 12 may determine the time period that the user held their breath based on the time difference between the end of the user's inhalation (e.g., or, in some examples, the start) and the detection of the user's exhalation. The time that the user's held their breath can be indicative of the amount of medicament that the user receives during their inhalation, as typically, a longer breath hold results in more medicament being delivered into the user's respiratory system.
Alternatively or additionally, the use determination system 12 may, for instance, comprise a mechanical switch configured to be actuated prior to, during, or after use of the inhaler. The mechanical switch may indicate that a dose of medicament has been primed and is ready for inhalation (e.g., such as by metering a dose from a hopper, advancing and/or opening a blister pack, breaking open and/or spinning a pill comprising medicament, etc.). In a non-limiting example, the inhaler 100 comprises a medicament reservoir (not visible in
Although described with reference to the inhaler 100, in some examples, the use determination system 12 and the transmission module 14 may be part of an accessory that is configured to be removably and replaceably attached to an inhaler. For examples, the accessory may be an electro-mechanical device that is configured to attached to an inhaler housing and/or a medication canister of an inhaler, and then later removed from the inhaler when, for example, the inhaler expires or is empty. An accessory would require additional user operation to physically attached the accessory to the inhaler, but would allow the accessory to be reused with multiple inhalers, thereby extending the useful life of the internal components.
Further, although described with reference to a pressure sensor, in some examples, the inhaler may include an acoustic sensor instead of a pressure sensor. The acoustic sensor may experience similar changes in measured acoustic signals when the relative position of the sensor to the flow channel of the inhaler changes due to a canister actuation. Accordingly, the use determination system may be configured to detect whether an inhalation by a user through the inhaler 100 occurs prior a medication canister of the inhaler 100 being depressed to release medication based on a distinguishable change is acoustic measurements received from the acoustic sensor. Further, the use determination system 12 may be configured to determine the position of the acoustic sensor and/or the medication canister based on the received acoustic measurements.
Although described with reference to a pressure sensor, in some examples, the inhaler may include a flow sensor instead of a pressure sensor. The flow sensor may experience similar changes in measured flow signals when the relative position of the sensor to the flow channel of the inhaler changes due to a canister actuation. Accordingly, the use determination system may be configured to detect whether an inhalation by a user through the inhaler 100 occurs prior a medication canister of the inhaler 100 being depressed to release medication based on a distinguishable change is flow measurements received from the flow sensor. Further, the use determination system 12 may be configured to determine the position of the flow sensor and/or the medication canister based on the received flow measurements.
The memory of the use determination system 12 may comprise a computer-readable storage media or machine-readable storage media that maintains computer-executable instructions for performing one or more as described herein. For example, the memory may comprise computer-executable instructions or machine-readable instructions that include one or more portions of the procedures described herein. The use determination system 12 may access the instructions from memory for being executed to cause the use determination system 12 to operate as described herein, or to operate one or more other devices as described herein. The memory may comprise computer-executable instructions for executing configuration software. For example, the computer-executable instructions may be executed to perform the procedure 800 as described herein. Further, the memory may have stored thereon one or more settings and/or control parameters associated with the use determination system 12.
The inhaler 210 may be a pMDI inhaler that includes a generally cylindrical medicament canister 11 that has at its lower end a metering valve for controlled release of single doses of a medicament through a hollow valve stem 15 of the inhaler 210. The metering valve may be actuated by pressing the valve stem 15 into canister 11. Further, in some examples, the inhaler 210 may be a breath actuated MDI, and in such instances, the metering value may be actuated by the valve stem 15 being pressed into the canister 11 in response to a user's inhalation.
The canister 11 may be received in an inhaler housing 20, which includes a mouthpiece 24. In the illustrated example of
At the lower end of the receiving portion, the inhaler housing 20 includes a hollow socket 30. The valve stem 12 of the drug container 11 may be seated in the socket 30. The socket 30 defines a duct 31 leading from the exit of the valve stem 12 to a nozzle orifice 32. The nozzle orifice 32 opens out into the interior of the inhaler housing 20 in a lateral direction that is transverse to the cylinder axis of the receiving portion, but not necessarily perpendicular to the cylinder axis.
The transverse leg of the L-shaped housing 20 may extend in the same lateral direction as the nozzle orifice 32. At its far end, it forms the mouthpiece 24 for insertion into the mouth of a patient. The mouthpiece 24 is laterally open at its end 25. In some examples, the mouthpiece 24 has a flattened cross-sectional shape adapted to the anatomy of a human patient's mouth. This cross-sectional shape is generally different from the cross-sectional shape of the receiving portion.
The open upper end 22 of the receiving portion of the inhaler housing 20 together with the circumferential wall of the canister 11 forms an air inlet, allowing air to enter the inhaler 210. The open end 25 of the mouthpiece 24 forms an air outlet. An airflow path exists through the inhaler housing 20 between the air inlet and the air outlet (e.g., the mouthpiece 24). The nozzle orifice 32 is disposed in this airflow path. Downstream from the nozzle orifice 32, the inhaler housing 20 may define a mixing zone 33 for mixing the airflow with the drug released from the canister 11.
In use, a user holds the inhaler 210 and applies his mouth to the mouthpiece 24. The user then inhales through the mouthpiece 24, thereby creating an air flow F1 through the inhaler housing 20 from the air inlet to the air outlet. After the patient has started inhaling through the mouthpiece 24, the canister 11 is pressed downwardly to release a dose of drug (e.g., in response to a user's physical actuation of the canister 11 or through a breath actuated actuation mechanism of the inhaler 210). Due to the pressure in the canister 11, the medicament may be propelled through the duct 31 and the nozzle orifice 32 into the mixing zone 33, where it mixes with the airflow to form an aerosol flow F1′, and is dispensed to the user.
As noted above, the electronics module 40 may include a use determination system (e.g., the use determination system 12) and a transmission module (e.g., the transmission module 14). For example, the electronics module 40 may include a processor 42, memory, a power source 44, a communication circuit 46 (e.g., transmitter and/or receiver), a pressure sensor 48, and in some instances, one or more additional sensors, such as those described with reference to the inhaler 10 of
The memory of electronics module 40 may comprise a computer-readable storage media or machine-readable storage media that maintains computer-executable instructions for performing one or more as described herein. For example, the memory may comprise computer-executable instructions or machine-readable instructions that include one or more portions of the procedures described herein. The processor 42 may access the instructions from memory for being executed to cause the processor 42 to operate as described herein, or to operate one or more other devices as described herein. The memory may comprise computer-executable instructions for executing configuration software. For example, the computer-executable instructions may be executed to perform at least a portion of the procedure 800 as described herein. Further, the memory may have stored thereon one or more settings and/or control parameters associated with the electronics module 40.
The communication circuit 46 may include one or more semiconductor chips, integrated circuits, and/or the like configured to implement the logic and procedures of the communication protocol. The communication circuit 46 may include radio frequency (RF) hardware such as amplifier(s), oscillator(s), modulator circuit(s), antenna(s), antenna tuner(s), and/or the like in order to transmit signals wirelessly using the communication protocol. The RF hardware may be implemented in whole or in part on the semiconductor chip(s), integrated circuit(s), and/or the like configured to implement the logic and procedures of the communication protocol. In some examples, the communication circuit 46 is configured to transmit and/or receive data via Bluetooth®. Bluetooth® may be used because the relatively low energy associated with transmitting and receiving may preserve the battery life of the respective inhaler. Moreover, no internet connection need be established in order for the respective encrypted data to be transmitted.
The pressure sensor 48 may be a differential pressure sensor (e.g., sometimes referred to as a relative pressure sensor) or a barometric pressure sensor (e.g., sometimes referred to as an absolute pressure sensor). The pressure sensor 48 can, in particular, be a differential pressure sensor that is based on a flow measurement principle. A differential pressure sensor of this type has two sensor ports: a sensor inlet and a sensor outlet. A pressure difference between the sensor inlet and the sensor outlet causes a sensor gas flow through a sensor flow channel defined inside the differential pressure sensor. A flow-sensitive structure is arranged adjacent to the sensor flow channel for measuring a flow rate of the sensor gas flow through the sensor flow channel. Thus, a differential pressure sensor of this type essentially acts as a flow sensor that is configured to determine the pressure difference based on the determination of a flow rate through a flow channel between the sensor ports.
In some examples, when the pressure sensor 48 is a barometric pressure sensor, the processor 42 may receive consecutive measurements from the barometric pressure sensor to monitor a change or difference in the measurements that is indicative of a user's inhalation. For example, the processor 42 may be configured to receive a first measurement (or series of measurements, such as a rolling average) prior to the user's inhalation, and use this measurement(s) to calculate a tare value. The tare value may be an absolute baseline reference reading that is taken when the canister is at the first position (e.g., an undepressed position) without a user's inhalation. The processor 42 may be configured to determine the pressure change due to the user's inhalation by calculating the tare value from subsequent pressure measurements received from the pressure sensor 48. Accordingly, the tare value may be used to determine a change in air pressure that may be indicative of the start of an inhalation event (e.g., a slope that exceeds a threshold indicative of inhalation, a flow rate that exceeds an inhalation threshold, etc.).
The electronics module 40 may include a pressure port 49. If a differential pressure sensor is used, one of the sensor ports of the sensor is pneumatically connected to the pressure port 49 in a fluid-tight manner, while a second pressure port is pneumatically connected to the environment of the electronics module 40 in a region that is not influenced by the air flow F1. To this end, in some examples, the electronics module 40 may include a reference port (not shown) in the form of an opening, the opening being arranged in a region of the electronics module 40 that faces away from the inhaler 210. The opening may cause the pressure inside the electronics module 40 to be equal to the pressure of the environment of the electronics module 40 in a region that is unaffected by the air flow F1. The sensor port that is not connected to the pressure port 49 can therefore be simply open towards the inside of the electronics module 40, without a fluid-tight connection being required between this sensor port and the reference port. If a barometric pressure sensor is used, then only a single port is needed since the barometric pressure sensor is referenced to atmospheric pressure.
Once the electronics module 40 turns on, the pressure sensor 48 may begin generating pressure measurements and the processor 42 may look for a change in the air pressure, as detected using the pressure sensor. In some examples, the processor 42 may analyze a rolling number of consecutive pressure measurements to determine a tare value, or dynamic zero value, to calibrate the pressure sensor 48 to the atmospheric pressure, and then use the tare value to determine a change in air pressure that may be indicative of the start of an inhalation event (e.g., a slope that exceeds a threshold indicative of inhalation, a flow rate that exceeds an inhalation threshold, etc.).
The processor 42 may be configured to receive pressure measurements from the pressure sensor 48, and determine one or more usage events or usage parameters based on the pressure measurements. Alternatively or additionally, the processor 42 may be configured to detect usage events based on feedback from other sensors or switches of the inhaler 210. For example, a usage event may include usage of the inhaler 210, such as a detection that the inhaler 210 is being handled by the user, a priming of a dose of medicament in the inhaler, such as the shaking of the inhaler 210 (e.g., when the inhaler 210 is a MDI), the recording of an inhalation through the inhaler 210 by a user (e.g., an inhalation event), a movement of a mouthpiece cover of the inhaler 210 from a closed to an open position, the actuation of a switch of the inhaler or a twist of a cap of the inhaler that advances a blister strip or prepares a dose of medicament, and/or any combination thereof. Further, the processor 42 may timestamp and/or geotag the events and/or usage parameters (e.g., using a real-time stamp or a relative time stamp that begins when the user first operates the inhaler
Each usage event may include one or more usage parameters that are determined by the electronics module 40. Usage parameters may include any number of parameters indicative of a usage event at the inhaler 210 by a user. For example, usage parameters may include the duration of the shaking of the inhaler 210, the orientation of the inhaler 210 during an inhalation, the coordination of the actuation of a medication canister 11 of the inhaler with an inhalation by a user, the temperature or humidity of the inhaler 210 during an inhalation, and/or any combination of inhalation parameters (e.g., flow rate, duration, etc.) that are measured during an inhalation event. The usage parameters may be measured by the processor 42, for example, in response to detecting a given usage event. Specifically, and as further described herein, the processor 42 may measure one or more inhalation specific usage parameters in response to detecting an inhalation event. The usage parameters measured by the processor 42 for an inhalation event, also referred to herein as inhalation parameter(s) (e.g., as the relevant device is an inhaler), may include one or more of: a peak inspiratory/inhalation flow (PIF), an inhalation volume, a time to peak inhalation flow, and/or an inhalation duration. The processor 42 may send, via the communication circuit 46, usage events and/or usage parameters to the external device 60.
The processor 42 may receive pressure measurements from the pressure sensor 48, and may calculate one or more inhalation parameters based on the pressure measurements. The inhalation parameter may be, for example, at least one of flow rate, a PIF, an inhalation volume, a time to peak inhalation flow, and/or an inhalation duration. As detailed further herein, the processor 42 may use the inhalation parameter to classify a respective usage event and/or inhalation event (e.g., a good inhalation event, a fair inhalation event, a low/no inhalation event, an exhalation event, a possible air vent block event, etc.). Further, in some examples, the processor 42 may determine and store a flow profile (e.g., a series of consecutive pressure measurements) associated with a usage event. As described herein, these inhalation parameters (e.g., also referred to herein as inhalation parameters) may be used to assess the user's compliance, which may provide valuable insight into the state of the user's respiratory disease (e.g., the likelihood that the patient is to experience an exacerbation event) and/or the patient's sensitivity to current or changing environmental conditions (e.g., heat, air quality, humidity, etc.). Further, although described at times in reference to the received pressure measurements, in some examples, the processor 42 may convert the received pressure measurements to a corresponding flow rate, and use the corresponding flow rates to determine one or more of the events and/or parameters described herein.
The usage information determined by the processor 42 include a classification of one or more inhalation events. For example, if the peak inhalation flow is between 0 and a lower flow rate (e.g., 30 liters per minute), the inhalation event is classified as “low inhalation” (less than or equal to 30 liters per minute) or as “no inhalation”. If the peak inhalation flow is greater than the lower flow rate (e.g., 30 LPM) and less than or equal to an intermediate flow rate (e.g., 45 liters per minute), the inhalation event is classified as “fair”. If the peak inhalation flow is greater than the intermediate flow rate (e.g., 45 LPM) and less than or equal to an upper flow rate (e.g., 200 liters per minute), the inhalation event is classified as a “good inhalation”. If the peak inhalation flow is above the upper flow rate (e.g., 200 liters per minute), the inhalation event is classified as an excessive inhalation event and/or a “possible air vent block”.
The inhalation event may be classified as an “exhalation”, for example, if the processor 42 receives pressure measurements that indicate a positive change in pressure. The classification of inhalation parameter(s) as a respective inhalation event (e.g., a good inhalation event, a fair inhalation event, a low/no inhalation event, an exhalation event, a possible air vent block event, etc.) may be based on or result from calculations performed at the processor 42 and/or at the external device 60. Finally, it should be appreciated that the flow rates provided are examples, and that the classification of inhalation events may be based on a different ranges of flow rates than those provided herein.
An inhalation may be associated with a decrease in the pressure in the airflow channel of the inhaler 210 relative to when no inhalation is taking place. The point at which the pressure change is at its greatest may correspond to the peak inhalation flow. The processor 42 may detect this point in the inhalation. Alternative ways of measuring the parameter, such as via a suitable flow sensor, can also be used.
The pressure change associated with an inhalation may alternatively or additionally be used to determine an inhalation volume. This may be achieved by, for example, using the pressure change during the inhalation measured by the pressure sensor to first determine the flow rate over the time of the inhalation, from which the total inhaled volume may be derived.
The pressure change associated with an inhalation may alternatively or additionally be used to determine an inhalation duration. The time may be recorded, for example, from the first decrease in pressure measured by the pressure sensor, coinciding with the start of the inhalation, to the pressure returning to a pressure corresponding to no inhalation taking place.
The inhalation parameter may alternatively or additionally include the time to peak inhalation flow. This time to peak inhalation flow parameter may be recorded, for example, from the first decrease in pressure measured by the pressure sensor, coinciding with the start of the inhalation, to the pressure reaching a minimum value corresponding to peak flow.
The pressure port 49 of the electronics module 40 may be aligned with the open upper end 22 of the housing 20. The pressure sensor 48 may be pneumatically coupled to the pressure port 49. The pressure port 49 may be arranged such that the air flow F1 passes beneath the pressure port 49 immediately before it enters the inhaler housing 20 at the air inlet. In some examples, the electronics module 40 does not have any structure that projects into the air flow F1. In such examples, it is ensured that the air flow F1 is disturbed as little as possible by the presence of the electronics module 40. Further, in some examples, the pressure sensor 48 and the pressure port 49 may be located external to the airflow channel F1 and F1′ through which air and the medicament is drawn by the user during inhalation.
In use, the air flow F1 caused by inhalation by the patient causes a negative pressure at the pressure port 49 due to the Bernoulli/Venturi effect caused by the acceleration of the air flow when it enters the inhaler 210. The magnitude of the negative pressure is directly related to the magnitude of the flow rate of the air flow F1 and the relative distance between the pressure sensor 48 (e.g., the pressure port 49) and the open upper end 22 of the housing 20. The negative pressure is registered by the pressure sensor 48. The processor 42 receives the pressure measurements from the pressure sensor 48, and may determine one or more inhalation parameters, such as flow rate.
When the canister 11 is actuated, the position of the pressure sensor 48 (e.g., and the pressure port 49) relative to the airflow channel of the inhaler 210 and the mouthpiece 24 of the inhaler 210 may change.
The canister 311 is in a non-actuated position in
Referring back to
At the lower end within the inhaler 320, the inhaler 320 may include a hollow socket 330 (e.g., similar to the hollow socket 30 of the inhaler 210). A valve stem of the drug container may be seated in the hollow socket 330 when the container is installed within the inhaler 320. The hollow socket 330 may define a duct leading from the exit of the valve stem to a nozzle orifice. Finally, the inhaler 320 may include a mouthpiece 324.
The electronics module 340 may be located such that a pressure port (e.g., the pressure port 49) may be aligned between any of the spacer ribs 323a-h. In some examples, the pressure port of the electronics module 340 may be aligned at a position A that is located between with the spacer ribs 323a and 323b. When aligned at the position A, the pressure port may be configured such that is aligned with an opening between the medication canister and the housing wall 321 (e.g., aligned with the air channel that is located as position A). However, in other examples, the pressure port of the electronics module may be aligned at a different, radial position along the housing wall 321. For example, the pressure port may be aligned at a position B that is located between the spacer ribs 323a and 323h, a position C 1 that is located between the spacer ribs 323g and 323f, a position D that is located between the spacer ribs 323e and 323d, or a position F that is located between the spacer ribs 323c and 323b. Further, although described as including eight spacer ribs 323, the inhaler 320 may include more or less spacer ribs, and the spacer ribs may be located in different radial positions along the housing wall 321. As such, the pressure port of the electronics module 340 may be located in a position other than those described herein.
Referring back to
After the user begins inhaling, the user may actuate the canister at 504, for example, through the application of a force to the top of the canister or through the force of their inhalation, in the case of a pMDI. When the canister actuates, the position of the pressure sensor relative to the flow channel of the inhaler may change (e.g., such as the change from the distance D1 to the distance D2 illustrated in
The user may continue to inhale through the mouthpiece of the inhaler after actuating the canister at 504. As such, the received pressure measurements and/or calculated flow rates may continue to increase (e.g., increase in the negative direction). At some point, the user's inhalation will begin to slow down, such as is represented by 506 in the flow diagram 500. Then, at 508, the user may stop inhaling and may release the canister, which will result in the received pressure measurements and/or the calculated flow rates returning to their original value prior to the user's interaction, which in this example is 0 LPMs. In examples that incorporate a barometric pressure sensor, the processor may be configured to zero out an average of the barometric pressure prior to inhalation to determine the resultant change in pressure that is due to the user's inhalation and the canister actuation.
The pressure measurement profile 520 of
Referring back to
The pressure sensor 48 and/or the pressure port 49 may be attached to or moveable in relation to any movement of the canister 11. As such, when the canister 11 is depressed either by the user's actuation or inhalation (e.g., in the case of a breath actuated MDI), the pressure sensor 48 and/or pressure port 49 is configured to move relative to the flow channel of the inhaler 210. Accordingly, (e.g., while a user is inhaling through the inhaler 210) the pressure sensor 48 may be configured to measure a first pressure when the pressure sensor 48 is in the first position (e.g., prior to the actuation of the canister 11) relative to the flow channel of the inhaler 210, and a distinguishable second pressure when the pressure sensor 48 is in the second position (e.g., a depressed position to release a dose of medication) relative to the flow channel of the inhaler 210.
While the user is inhaling through the inhaler 210, the pressure measurements may change by a distinguishable amount (e.g., a step, such as shown in the examples of
In some examples, the pressure sensor 48 is configured such that it does not extend into the inhaler housing 20 when the pressure sensor 48 is in the first position and/or the second position. For example, the pressure sensor 48 may be configured such that a gap exists between the pressure sensor 48 (e.g., and pressure port 49) and the airflow channel and/or the open upper end 22 of the inhaler 210 when the electronics module 40 and/or the canister 11 are in the first position and/or the second position. As noted herein, the pressure port 49 may be aligned with an opening between the canister 11 and the housing 20 (e.g., the open upper end 22) when the electronics module 40 is connected to the canister 11. However, in some examples, the pressure port 49 does not extend into or between the housing 20 and the canister 11. Accordingly, in some examples, the pressure sensor 48 is pneumatically coupled to the airflow channel, but the pneumatic coupling is rather weak (e.g., due to the gap between the sensor port and the inhaler housing). Since, in some examples, the pneumatic coupling between the pressure sensor 48 and the flow channel of the inhaler 210 is rather weak, the pressure measurements may change by a distinguishable amount when the position of the pressure sensor 48 and/or pressure port 49 relative to the flow channel changes upon actuation of the canister 11.
The processor 42 and/or the pressure sensor 48 may be configured with a first flow rate calibration curve (e.g., the profile 410 from
The electronics module 40 may turn on the pressure sensor 48 and/or begin receiving measurements from the pressure sensor 48 in response to switching from a low power state, such as an off state or a sleep state, to an on state. The processor 42 may calculate a flow profile using the received pressure measurements. The processor 42 may compare the measurements received from the pressure sensor 48 (e.g., the flow profile) to one or more thresholds and determine whether the measurements are indicative of an inhalation by the user. For example, the processor 42 may be configured to compare the pressure measurements to an inhalation threshold, and determine (e.g., generate) an inhalation event based on the flow rates received from the pressure sensor 48 exceeding the inhalation threshold. The processor 42 may be configured to compare the pressure measurements to a canister actuation threshold, and determine (e.g., generate) a canister actuation event based on the flow rates exceeding the canister actuation threshold. The canister actuation threshold may be larger than the inhalation event (e.g., a larger negative flow rate), for example since the actuation of the canister 11 may bring the pressure sensor 48 closer to the flow channel.
The processor 42 may be configured to compare the pressure measurements to a canister released threshold, and detect the movement of the canister back to the first position based on the flow rates falling below the canister released threshold. The processor 42 may be configured to determine a duration of an inhalation event based on the amount of time that the pressure measurements (e.g., flow rates) exceed the inhalation threshold. Alternatively, the duration of the inhalation event may start at the time of the canister actuation event and ends when the flow rates fall below the inhalation threshold. Although described with reference to pressure measurements, in some examples, the processor 42 may be configured to generate one or more inhalation parameters (e.g., such as flow rates) based on the received pressure measurements, and compare the inhalation parameters to one or more thresholds to determine one or more events.
The processor 42 may be configured to generate one or more error events based on feedback from the pressure sensor 48. For example, the processor 42 may be configured to generate a late inhalation error event when the detection of an inhalation occurs after the medication canister 11 is depressed. For example, the processor 42 may be configured to detect an inhalation event based on the pressure measurements received from the pressure sensor 48 exceeding an inhalation threshold (e.g., a pressure threshold and/or a flow rate threshold), and detect a canister actuation event based on the pressure measurements exceeding a canister actuation threshold (e.g., a pressure threshold and/or a flow rate threshold). The processor 42 may be configured to generate the late inhalation error event when the inhalation event occurs after the canister actuation event (e.g., or occurs before the canister actuation event, but not sufficiently far in advance of the canister actuation event). For example, the processor 42 may detect a user's inhalation and detect the canister 11 being released (unactuated) during the user's inhalation. In such instances, the processor 42 may generate a late inhalation event. Further, in some instances, the processor 42 may not detect a canister actuation or release (e.g., because the canister 11 was actuated prior to the user's inhalation started and released after the inhalation ended, or the canister wasn't actuated at all). In response, the processor 42 may generate a late inhalation error event.
In some examples, the processor 42 may be configured to send, via the communication circuit 46, the late inhalation error event to the external device 60 for display via a user interface of the external device 60. The late inhalation error event may include a notification that the user actuated the canister too early/inhaled too late and/or may indicate the relative timing of the user's inhalation and the canister actuation and/or release. Further, in some instance, the late inhalation error event may indicate that the processor 42 could not determine whether the canister 11 was actuated before the inhalation began or whether the canister 11 was simply not actuated at all (e.g., when the processor 42 does not detect the canister actuation or release during the user's inhalation).
The processor 42 may be configured to generate a late actuation error event when the pressure measurements (e.g., flow rates) exceed a threshold for a period of time that exceeds a duration threshold prior to the detection of the canister 11 being actuated. For example, the processor 42 may determine that the user inhales for too long of a period of time prior to the canister 11 being actuated, and in response, generate the late actuation error event (e.g., an early inhalation error event). In some examples, the processor 42 may be configured to determine that the pressure measurements resulted in a PIF that exceeded a threshold (e.g., 30 LPM or 45 LPM) prior to the canister being actuated, and in response, generate the late actuation error event. The processor 42 may be configured to send, via the communication circuit 46, the late actuation error event to the external device 60 for display via a user interface of the external device 60. The late actuation error event may include a notification that the user actuated the canister too late (e.g., or that the user inhaled too early) and/or may indicate the relative timing of the user's inhalation and the canister actuation.
The processor 42 may be configured to generate an on-time inhalation event if the user's inhalation occurred within a predetermined time period before the canister was actuated (e.g., within 300-800 milliseconds before canister actuation). Further, the processor 42 may generate the on-time inhalation event if the user's inhalation occurred the predetermined time period before the canister was actuated and if it reach a particular threshold value (e.g., a PIF value, such as a PIF of at least 10 or 15 LPM) before the canister was actuated (e.g., and in some instances, did not reach an upper threshold value, such as 40 LPM prior to canister actuation), but did not trigger a late actuation error event.
The processor 42 may be configured to send the events, via communication circuit 46, to the external device 60 for display via a user interface of the external device 60 (e.g., a smartphone, tablet, PC, etc.). Alternatively or additionally, the processor 42 may send the pressure measurements and/or calculated inhalation parameters to the external device 60, and the external device 60 may determine any combination of the events described herein, for example, prior to displaying an indication of the events via the user interface. Further, the processor 42 and/or the external device 60 may timestamp and/or geotag the events and/or usage parameters (e.g., using a real-time stamp or a relative time stamp that begins when the user first operates the inhaler.
In some examples, the processor 42 may include a mechanical switch configured to be actuated prior to, during, or after use of the inhaler 210. The mechanical switch may indicate that a dose of medicament has been primed and is ready for inhalation (e.g., such as by metering a dose from a hopper, advancing and/or opening a blister pack, breaking open and/or spinning a pill comprising medicament, the inhaler has been shaken, etc.).
In some examples, the inhaler may be a dry powder inhaler that comprises dry powder medicament. The inhaler 210 may include a medicament reservoir (that is different from the canister 11) that houses medicament (e.g., a blister strip, a hopper, etc.), and/or a dose metering assembly configured to meter a dose of the medicament from the reservoir. The dose metering assembly may include a bellows that is configured to meter a dose of dry powder medicament from a hopper, a blister strip advancement and opening mechanism, a chamber configured to open a pill of dry powder medicament, and/or the like. The processor 42 may be configured to register the metering of the dose by the dose metering assembly, each metering being thereby indicative of the inhalation performed by the user using the inhaler 210. Accordingly, the inhaler 210 may be configured to monitor the number of inhalations of the medicament, since the dose should be metered via the dose metering assembly before being inhaled by the user. Alternatively or additionally, the processor 42 may be configured to register a usage event based on the metering of the dose by the dose metering assembly and register another usage event based on feedback from one or more sensors. In such examples, the processor 42 may be configured to correlate the timing and/or duration of each of the usage events, which for example, may be used to determine whether the user proper primed the inhaler 210 and properly inhaled the dose of medicament, since both steps are valuable in determining whether a successful dose is received.
The electronics module 40 may include one or more of a switch configured to detect usage of inhaler 210, one or more sensors configured to detect use of inhaler 210 (e.g., one or more sensors in addition to the pressure sensor 48), one or more buttons configured to be depressed upon use of inhaler 210, and/or the like. As such, a usage parameter may be one or more measurements performed by the electronics module 40, such as a count of the number of uses inhaler 210, a measure of airflow of inhaler 210, a detection of the canister 11 being actuated, and/or another measurement indicating the usage of the medicament of inhaler 210. The electronics module 40 may register each inhalation in different manners and/or based on additional or alternative feedback. For example, the electronics module 40 may be configured to register an inhalation by the user when the feedback from a suitable sensor indicates that an inhalation by the user has occurred, for example when a pressure measurement or flow rate exceeds a predefined threshold associated with a successful inhalation, when a medication canister of the inhaler is actuated, etc.
The electronics module 40 includes a housing, which in some examples, may be fastened to the canister 11 through fastening means (not shown). The fastening structure may include any combination of elements, such as a magnet, glue, Velcro®, a cavity formed in a housing of the electronics module 40 and configured to fit around a portion of the canister 11 and/or inhaler 210 in a press fit, a strap or band configured to be tied to secure the housing of the electronics module 40 to the canister 11 and/or inhaler 210, a strap or band configured to elastically secure the housing of the electronics module 40 to the canister 11 and/or inhaler 210 similar to a rubber band, a clip configured to clip t the housing of the electronics module 40 to the canister 11 and/or inhaler 210, and/or a guide track configured to slidably receive a portion of the inhaler 210 therein. The electronics module 40 may be fastened/attached to the canister 11 in a defined axial position. In some examples, the electronics module 40 may be configured to determine the axial position that it is installed based on received pressure measurements (e.g., during an actuation and inhalation by the user).
The electronics module 40 may include an indicator, such as a light, speaker, a display, a vibrating element, etc., that is configured to generate user feedback for the user. For instance, the indicator may be configured to generate an audible signal that indicates to the user whether the flow rate is within a desired range, for example, after inhalation but prior to canister actuation. As another example, the indicator may generate a tactile signal in the form of a vibration pattern that indicates to the user whether the flow rate is within a desired range, for example, after inhalation but prior to canister actuation. As yet another example, the indicator may generate a visual signal that indicates to the patient whether the flow rate is within a desired range, for example, after inhalation but prior to canister actuation.
Further, as previously noted, the timing between the user inhalation and canister actuation not only affects the amount of medicament that the user receives, but is also affects how deep in the lungs the medicament is delivered. Some active pharmaceutical ingredients are used to target specific portions of the user's respiratory track, and as such, it is desirable to deliver a maximum amount of each dose to that targeted portion of the user's respiratory track. For example, some medications may target the upper airways/respiratory track of the user, while others might target the lower airways/respiratory track of the user. In such instances, the processor 42 of the electronics module 40 may be configured to generate the canister actuation notification during the user's inhalation (e.g., based on inhaled volume and/or duration) to alert the user to actuate the canister to deliver a dose of medicament at a time that will increase the amount of the dose that is delivered to the targeted portion of the user's respiratory track. The processor 42 may generate the canister actuation notification using the indicator of the electronics module 40 (e.g., the processor 42 may illuminate a light of the electronics module 40, cause a speaker of the electronics module 40 to output an audible sound, generate a tactile signal in the form of a vibration pattern using a vibrating element, etc.).
For instance, the processor 42 may receive pressure measurements from the pressure sensor 48 during a user's inhalation. As noted above, the processor 42 may determine one or more inhalation parameters based on the pressure measurements, such as inhaled volume and/or inhalation duration. The processor 42 may generate the canister actuation notification when the inhalation parameter reaches a particular threshold (e.g., a canister actuation notification threshold), where the threshold may be dependent on the portion of the user's respiratory track that is targeted by the medicament of the inhaler. When the inhalation parameter is inhaled volume, the canister actuation notification threshold may represent a volume of the user's inhalation. When the inhalation parameter is inhalation duration, the canister actuation notification threshold may represent a duration of the user's inhalation. For example, when the medicament is used to target the upper airways, the threshold may be a larger value of the inhalation parameter (e.g., a larger inhaled volume or larger/longer inhalation duration), such that the processor 42 is configured to generate the notification later during the inhalation (e.g., to ensure that a greater portion of the medication is provided to the upper airways, and less is delivered to the lower airways of the user). Conversely, when the medicament is used to target the lower airways, the threshold may be a smaller value of the inhalation parameter (e.g., a smaller inhaled volume or smaller/shorter inhalation duration), as compared to when the medicament is used to target the upper airways. As such, the processor 42 may be configured to generate the notification earlier during the user's inhalation, for example, to ensure that a greater portion of the medication is provided to the lower airways, and less is delivered to the upper airways of the user.
Further, the processor 42 may be configured to generate one or more notifications based on a comparison of the generation of the canister actuation notification and the detection of the actuation of the canister 11. For example, the processor 42 may be configured to send data to the external device 60, where the data indicates the relative timing between the generation of the canister actuation notification and the detection of the actuation of the medication canister 11. The external device 60 may receive the data and cause a display (e.g., a display of the external device or of a different device) to present a notification to the user that indicates the relative timing between the generation of the canister actuation notification and the detection of the actuation of the medication canister 11. In some examples, the notification may indicate that the user did not actuate the canister in a timely manner after the generations of the canister actuation notification. This may assist the user by informing them as to their relative coordination between the generation of the canister actuation notification and the processors 42 detection of the actuation of the medication canister 11.
As noted above, the processor 42 may be configured to detect a user's exhalation through the inhaler 20. Further, the processor 42 may be configured to detect the duration of time that a user holds their breath based on measurements received from the pressure sensor 48. For example, the processor 42 may detect the beginning of the user's inhalation when the received pressure measurements exceed an inhalation threshold (e.g., a slope in pressure measurements that is indicative of a user's inhalation), and detect when the user stops inhaling (e.g., has inhaled completely) based on the received pressure measurements (e.g., when the pressure measurements return to or fall below a particular value). The processor 42 may detect when the user exhales their breath based on received pressure measurement (e.g., based on the user exhaling through the inhaler 20). The processor 42 may determine the time period that the user held their breath based on the time difference between the end of the user's inhalation (e.g., or, in some examples, the start of the user's inhalation) and the detection of the user's exhalation. The time that the user's held their breath can be indicative of the amount of medicament that the user receives during their inhalation, as typically, a longer breath hold results in more medicament being delivered into the user's respiratory system.
Further, the processor 42 may be configured to generate one or more notifications based on the time that the user held their inhalation. For example, the processor 42 may be configured to send data to the external device 60, where the data indicates the time that the user held their inhalation. The external device 60 may receive the data and cause a display (e.g., a display of the external device or of a different device) to present a notification to the user that indicates the time that the user held their inhalation. In some examples, the notification may indicate that the user did not hold their inhalation for a long enough time to ensure a proper dose of medicament was received. Alternatively or additionally, the processor 42 may cause one or more indicators of the electronics module 40 to change states when the processor 42 determines that the user has held their inhalation for a predetermined amount of time (e.g., which may be adjustable based on medication type and target region of the respiratory track), for example, to indicate that the user may stop holding their inhalation and exhale (e.g., by turning a light from on to off, changing the color state of a light, generating an audible output, etc.).
The electronics module 40 may use feedback from a sensor, such as an accelerometer and/or touch sensitive device to change power states. For example, the electronics module 40 may reside in a low power state, such as an off state or a sleep state, when not in use. During the low power state, any combination of sensors, the communication circuit 46, and/or various pins on the processor 42 may be off (e.g., other than the sensor and associated pin on the processor that is used to trigger the electronics module 40 to switch power states). The electronics module 40 may switch from the low power state to an on state in response to receiving feedback from a sensor, such as feedback from an accelerometer that indicates that the user is shaking the inhaler 210 (e.g., an MDI inhaler) or feedback from a touch sensitive device that indicates that the user has the inhaler 210 in their hand. The electronics module 40 may turn on the communication circuit 46 and/or the pressure sensor 48, and/or begin receiving measurements from the pressure sensor 48 in response to switching from a low power state, such as an off state or a sleep state, to an on state.
The external device 60 may include a smart phone (e.g., an iPhone® smart phone, an Android® smart phone, or a Blackberry® smart phone), a personal computer, a laptop, a wireless-capable media device (e.g., MP3 player, gaming device, television, a media streaming devices (e.g., the Amazon Fire TV, Nexus Player, etc.), a tablet device (e.g., an iPad® hand-held computing device), a Wi-Fi or wireless-communication-capable television, a hub device or smart speaker (e.g., Amazon Echo, Google Home, etc.), or any other suitable Internet-Protocol-enabled device.
The external device 60 may be configured to execute a computer program (e.g., a mobile application) that causes the external device 60 to receive one or more signals from the electronics module 40 via the wireless link and to generate user feedback using an output device of the external device 60. For instance, the external device 60 may be configured to display user feedback and/or instructions for indicating the correct operation of the inhaler 210 on a display screen of the external device 60. The external device 60 may output an audible signal via a loudspeaker of the remote device that indicates the correct operation of the inhaler 210. The external device 60 may be configured to provide tactile feedback (e.g., by vibrating) depending on the manner in which the patient handles the inhaler. This can all be performed in real time with an inhalation by the user through the inhaler 210. The external device 60 may be configured to store received signals for later readout, and/or to transmit the received signals or data derived from the received signals to a remote server for analysis. This enables the monitoring of the usage of the inhaler 210 by medical personnel. In other embodiments, the inhaler 210 may be configured to communicate directly with a remote server, for example, when the electronics module 40 includes a cellular chipset.
The external device 60 may include a communication circuit, and as such may be configured to transmit and/or receive RF signals via a Wi-Fi communication link, a Wi-MAX communications link, a Bluetooth® or Bluetooth Smart communications link, a near field communication (NFC) link, a cellular communications link, a television white space (TVWS) communication link, or any combination thereof. As further described herein, the external device 60 may transfer data (e.g., through the public and/or private network) to a remote server using, for example, a communication interface published by the remote server, such as a dedicated API. For example, the external device 60 may send usage data relating to one or more paired inhalers 210 to the remote server.
The external device 60 may comprise any combination of a processor, memory, and/or software configured to perform the functions described herein for the external device 60. For example, the processor may be a general purpose processor programmed with computer executable instructions for implementing the functions of the external device 60. The processor may be implemented using a microprocessor or microcontroller configured to perform the functions of the external device 60. The processor may be implemented using an embedded processor or digital signal processor configured to perform the functions of the external device 60.
The memory of external device 60 may comprise a computer-readable storage media or machine-readable storage media that maintains computer-executable instructions for performing one or more as described herein. For example, the memory may comprise computer-executable instructions or machine-readable instructions that include one or more portions of the procedures described herein. The processor of the external device 60 may access the instructions from memory for being executed to cause the processor to operate as described herein, or to operate one or more other devices as described herein. The memory may comprise computer-executable instructions for executing configuration software. For example, the computer-executable instructions may be executed to perform at least a portion of the procedure 800 as described herein. Further, the memory may have stored thereon one or more settings and/or control parameters associated with the external device 60.
The external device 60 may include a display device and software (e.g., a mobile application) for visually presenting or displaying the inhaler data associated with a given usage parameters and/or data related to usage events through a graphical user interface (GUI) on the display device. The external device 60 may also provide alerts or notification via the GUI and/or via the inhaler 210 by sending the inhaler 210 a message that causes the inhaler 210 to illuminate a light source of the inhaler 210 and/or generate an audible alert by way of a speaker of the inhaler 210.
The external device 60 may determine any of the events described herein, and display any of the events described herein. For example, in addition to or as an alternative to the electronics module 40 determining the one or more events, the external device 60 may determine any combination of the events described herein. The events may include, but are not limited to the inhalation event, the canister actuation event, the canister, the late inhalation error event, the late actuation error event, the shake event, the no inhalation event, low inhalations event, good inhalation event, excessive inhalation event, exhalation event, underuse event, overuse event, inhaler cap openings or medication priming event (e.g., such as opening of a blister strip, the opening of a capsule, etc., as described further herein), etc.
The external device 60 may receive the event from the inhaler 210, and may display, via the display device, an indication of the event. For example, the external device 60 may display an indication of the position of the canister and/or pressure sensor relative to the user's inhalation flow profile so the user and/or health care provider can assess whether the user is actuating the canister too early, too late, or on time. Further, and for example, the external device 60 may display a notification for the late inhalation error event that indicates that the user inhaled too late (or actuated the canister too early) and/or may indicate the relative timing of the user's inhalation and the canister actuation. Similarly, external device 60 may display a notification for the late actuation error event that indicates that the user inhaled too early (or actuated the canister too late) and/or may indicate the relative timing of the user's inhalation and the canister actuation.
Table 1 provides flow rates (in liters per minute (LPM)) that are calculated based on a pressure port of an electronics module (e.g., the pressure port 49 of the electronics module 40) being aligned at various positions relative to the inhaler housing (e.g., the housing of the inhaler 210) while a flow controller applied a 28.5 LPM simulated inhalation flow through the mouthpiece of the inhaler for 2.5 seconds. As noted above with respect to
As shown in Table 1, the flow rates calculated when the canister was at the first position (e.g., prior to canister actuation) are distinguishably different from the flow rates calculated when the canister was at the second position (e.g., when the canister is actuated), for every position A-E. Accordingly, the electronics module and/or an external device that receives the pressure measurements may be configured to detect whether an inhalation occurs prior to the medication canister being depressed to release medication based on the pressure measurements, and/or determine the position of the pressure sensor and/or the medication canister based on the pressure measurements received from the pressure sensor while an inhalation is occurring through the mouthpiece of the inhaler.
Table 2 provides flow rates (in liters per minute (LPM)) that are calculated based on a pressure port of an electronics module (e.g., the pressure port 49 of the electronics module 40) being aligned at various positions relative to the inhaler housing (e.g., the housing of the inhaler 210) while a flow controller applied a 60 LPM and 100 LMP simulated inhalation flow through the mouthpiece of the inhaler for 2.5 seconds. It should be appreciated that, even though the positions A-E around the inhaler housing are the same as was performed during the tests in Table 1, the position of the pressure sensor is not absolutely identical for both tests.
As shown in Table 2, the flow rates calculated when the canister was at the first position (e.g., prior to canister actuation) are distinguishably different from the flow rates calculated when the canister was at the second position (e.g., when the canister is actuated), for every position A-E and for each of the simulated inhalation flows (e.g., at rates of 60 and 100 LPM). Accordingly, the electronics module and/or an external device that receives the pressure measurements may be configured to detect whether an inhalation occurs prior to the medication canister being depressed to release medication based on the pressure measurements, and/or determine the position of the pressure sensor and/or the medication canister based on the pressure measurements received from the pressure sensor while an inhalation is occurring through the mouthpiece of the inhaler.
The mobile device 702 may be an example of the external device 40 from
As noted above, the inhalation devices 701a, 702b may include a communication circuit, such as a Bluetooth radio, for transferring data to the mobile device 702. The data may include the measurement readings taken by the one or more sensors of the electronics modules of the inhalation devices 701a, 701b, parameters computed by the processor of the electronics modules, one or more events generated by the processor of the electronic modules, and/or other data captured by the inhalation devices 701a, 702b. The inhalation devices 701a, 702b may receive data from the mobile device 702, such as, for example, program instructions, operating system changes, dosage information, alerts or notifications, acknowledgments, etc.
The mobile device 702 may process and analyze the data to determine the usage parameters associated with the inhalation devices 701a, 702b. For example, the mobile device 702 may process the data to identify inhalation events, canister actuation events, error events, no inhalation events, low inhalations events, good inhalation events, excessive inhalation events and/or exhalation events. The mobile device 702 may also process the data to identify additional events. The mobile device 702 may further process the data to estimate the number of doses delivered and/or remaining and to identify error conditions, such as those associated with a timestamp error flag. The mobile device 702 may include a display and software for visually presenting the usage parameters through a GUI on the display.
The procedure 800 may begin at 802. At 804, the inhaler may receive sensor data. As noted above, the inhaler may include a pressure sensor, and in some instances, one or more additional sensors. As such, the inhaler may receive pressure measurements at 804. In some examples, the inhaler may receive other sensor data. The other sensor data may be used to trigger the inhaler to change from a low power state (e.g., an off or sleep state) to an on state, and/or cause the pressure sensor to turn on and configure the inhaler to begin receiving pressure measurements. Further, in some examples, the other sensor data may include a duration that the inhaler is shaken, the orientation of the inhaler, a temperature of the ambient air around the inhaler, a geographical location of the inhaler, etc.
At 806, the inhaler may detect that a user is inhaling through the inhaler based on the received sensor data (e.g., pressure measurements). For example, the inhaler may compare the received pressure measurements to one or more thresholds to determine whether the user is inhaling. Alternatively or additionally, the inhaler may calculate one or more flow rates using the pressure measurements, and compare the flow rates to one or more thresholds to determine whether the user is inhaling through the inhaler. In some examples, the thresholds may be an absolute value (e.g., 0.1 kPA or 10 LMP) or a slope threshold (e.g., a rate of change in the received pressure measurements or flow rate). Further, in some examples, the inhaler may be configured to generate a notification once the pressure measurements exceed a threshold that indicates that the user should actuate the canister (e.g., to deliver the medication to a targeted region of the user's respiratory track).
At 808, the inhaler may determine the position of a medication canister of the inhaler based on the received sensor data (e.g., the pressure measurements). For example, the inhaler may determine whether the canister is in an actuated position or a non-actuated position based on the pressure measurements. The inhaler may determine that the medication canister changed positions based on the received sensor data (e.g., the pressure measurements). As noted herein, the inhaler may determine that the pressure measurements and/or calculated flow rates exceed a threshold or a slope, and in response, determine that the canister has moved from a first position to a second position. It should be appreciated that the procedure 800 is not described in any temporally sequential manner, and that 806 and 808 may be performed in any order or simultaneously.
At 810, the inhaler may determine the timing of the user's inhalation relative to the actuation of the canister based on the received sensor data (e.g., the pressure measurements). For example, the inhaler may determine that the canister was actuated before the user inhaled, and in response, generate a late inhalation error event. The inhaler may determine that the user inhaled too far in advance of the canister being actuated (e.g., based on the user's inhalation reaching too high of a value (e.g., PIF) and/or occurring for too long a time period before the canister was actuated), and in response, generate a late actuation error event. Or the inhaler may generate an on-time inhalation event if the user's inhalation occurred within a predetermined time period before the canister was actuated, but did not trigger a late actuation error event.
At 812, the inhaler may notify the user of the timing between the user's inhalation and the actuation of the canister, before the procedure 800 exits. For example, the inhaler may notify the user of the occurrence of a late inhalation error event, a late actuation error event, and/or an on-time inhalation event using an indicator of the inhaler. For instance, the inhaler may play a distinctive sound through a speaker of the inhaler to indicate one or more of the events, illuminate a light on the inhaler to a distinctive color to indicate one or more of the events, etc. Alternatively or additionally, the inhaler may notify the user of the event by sending data to an external device (e.g., the external device 60) that causes the external device to display a notification to the user of the event. For example, the inhaler may send any combination of the sensor data (e.g., the pressure measurements), the late inhalation error event, the late actuation error event, and/or the on-time inhalation event, potentially along with one or more inhalation parameters to the external device. The external device may receive the sensor data, event(s), and/or parameters, calculate the events, if not already performed, and may display, via a display device of the external device, a notification to the user that indicates the event type and/or the associated parameters of their inhalation. For instance, in some examples, the external device may perform any combination of 808, 810, and 812.
Other variations to the disclosed embodiments can be understood and effected by those skilled in the art in practicing the claimed invention, from a study of the drawings, the disclosure, and the appended claims. In the claims, the word “comprising” does not exclude other elements or steps, and the indefinite article “a” or “an” does not exclude a plurality. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage. Any reference signs in the claims should not be construed as limiting the scope.
This application claims the benefit of Provisional U.S. Patent Application No. 63/149,250, filed Feb. 13, 2021, the disclosure of which is incorporated herein by reference in its entirety.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2022/053355 | 2/11/2022 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63149250 | Feb 2021 | US |
