Devices and systems for detecting and analyzing inhaler use - Patents.com

Abstract

Devices, methods and systems for detecting and analyzing inhaler use, particularly breath detection modules and inhaler device counters. The electronic inhaler counter device includes a rocker arm including a proximal end providing a pivot and a distal end providing a head, a return spring coupled to the rocker arm pivot, and a count switch, arranged such that in response to a first selected degree of linear drive motion, the rocker arm performs a first rocker movement and engages the count switch with the rocker head, and in response to further linear drive motion, the spring is engaged and enables the rocker arm to perform a second rocker movement to facilitate overtravel. The inhaler breath detection module coupled to the inhaler airway includes sensing means configured to provide a signal indicative of a change in a parameter of the inhaler airway as a function of time caused by an inhalation breath, and a controller configured to determine the presence of a breath based on the change in the parameter of the inhaler airway as a function of time.

Description

[Technical field]

[0001] The present application relates to devices, methods and systems for detection and analysis of inhaler use, and in particular to breath detection modules and inhaler device counters. [Background technology]

[0002] Many types of medicines are provided in a fluid form, such as a solution or suspension of particles in a propellant or emulsion, and are adapted for oral inhalation by a patient. As an example, the container might contain an asthma medication, such as fluticasone propionate.

[0003] To deliver the medication to the patient, the container operates with an actuator in what is commonly known as a pressurized metered dose inhaler (pMDI) system. The actuator includes a housing having an open container-loading end and an open mouthpiece. A nozzle element is disposed within the housing and includes a valve stem receiving hole that communicates with a nozzle orifice. The orifice is oriented toward the mouthpiece. To receive a properly metered dose of medication from the container, the patient attaches the container to the actuator through the container-loading end until the valve stem fits into the receiving hole of the nozzle element. With the container so attached, the opposite end of the container typically extends somewhat outside the actuator housing. The patient then places the mouthpiece into their mouth and pushes the exposed container end downward. This action displaces the container downward against the valve stem, thus unseating the valve. Due to the design of the valve, the design of the nozzle element, and the design between the interior of the container and the ambient air, a short burst of precisely metered atomized medicine is thereby delivered to the patient.

[0004] Such containers are filled with a predefined amount of active ingredient, i.e. medicine. Thus, the container can nominally deliver a predefined number of medicine doses before it has to be discarded. To visualize the number of remaining doses in such an inhaler device, it is preferable to provide a counter that indicates the amount of medicine remaining in the container. The counter thus provides an indication of when the inhaler device or container should be replaced. The indication of the "current status" can be either in an absolute concept, for example by indicating numerically the actual number of doses still available, or in a relative concept, for example by a color gradient from one color to another.

[0005] Non-Patent Document 1 distinguishes between overcounting (a count is recorded but no dose is ejected) and undercounting (a dose is ejected but not counted). Undercounting is a more dangerous failure mode because it may ultimately lead to the user believing that a dose is still available for inhalation when the container is empty. The FDA recommends that while overcounting is undesirable, undercounting should be avoided whenever possible.

[0006] Patent document 1 discloses a mechanical inhaler counter comprising a counter housing, a rocker arm having a pawl, the rocker arm being pivotally supported by the housing and arranged to perform a rocker movement in response to linear drive movement, a return spring for resetting the rocker arm, and a ratchet wheel engageable with the pawl and converting movement of the rocker arm into progressive rotational movement of an axle mechanism which advances a display means, the axle mechanism further comprising a spring-loaded friction brake and anti-reverse rotation means in the form of a worm gear, the display means including a rotatable indicator means having teeth which engage the worm gear. [Prior art documents] [Patent documents]

[0007] [Patent Document 1] International Publication No. 2006 / 110080 Brochure [Non-patent literature]

[0008] [Non-Patent Document 1] The Food and Drug Administration(FDA),(2003)Guidance for Industry:Integration of Dose-Counting Mechanisms into MDI Drug Products Summary of the Invention [Means for solving the problem]

[0009] Aspects of the invention are as set out in the independent claims and optional features are set out in the dependent claims. The aspects of the invention may be provided in conjunction with each other and features of one aspect may be applied to another aspect.

[0010] Aspects of the present disclosure relate to counting doses exhaled by an inhaler. The electronic counter design implements a displacement-based counting principle. This approach is inherently more reliable than force-based counting, since there is often significant force variation throughout the life of the container, the ambient temperature and humidity, as well as the direction of the applied force. During use, the electronic inhaler counter may register a count early in the container stroke, which may reduce the possibility of undercounting the exhaled dose. A possible advantage of the operating principle used in this design is that the spring-loaded pivot can remain in place until after the switch is actuated, so the switching point is well defined, which may also reduce the possibility of undercounting the exhaled dose. Also, available space can be utilized and the geometry can be tailored for best operation. Digital displays may also allow the displayed numbers to be larger relative to the small size of numbers on mechanical inhaler counters that must be fitted into the inhaler device, thus increasing the readability of the display with the use of a digital display.

[0011] Aspects of the present disclosure also relate to detecting and analyzing breathing technique during use of an inhaler. Inhalation rate is important when a patient uses an inhaler, as it can affect the delivery of the drug. With respect to pMDIs, it is generally believed in the literature that a low flow rate is beneficial as it promotes better deposition of the drug in the lungs.

[0012] A breath sensing solution may be advantageous because it can alert the user if a dose is administered improperly, which may affect the efficacy of the treatment. Additionally, a breath sensing solution may enable the user to receive feedback to improve their inhaler breathing technique, which may improve the efficacy of future treatments and therefore improve management of the user's condition. Good coordination of the user's inhalation and delivery of the dose is important for the efficacy of the treatment and therefore for the effective management of the user's condition. Potential modes of misuse may include, but are not limited to, incorrect timing of delivery / breathing, not inhaling, suboptimal inhalation flow profiles (i.e., too fast or too slow), and no breath hold after inhalation.

[0013] A breath-sensing solution may be advantageous by accurately detecting breaths at flow rates as low as 30 l / min (the lowest flow rate actually achieved by a user trained to inhale correctly through a pMDI, as documented).

[0014] The breath sensing solution may be advantageous by not affecting the existing air flow path in the inhaler device. This may allow compatibility with existing inhalers while not affecting or impeding the exhalation and delivery of medication. The breath sensing solution may also be advantageous because the electronics and sensors for breath sensing may fit within the footprint of existing mechanical inhaler adapter counter modules (ACMs) such as those disclosed in WO 2006 / 110080. This may allow compatibility with existing inhalers and inhaler counter systems.

[0015] A breath sensing solution may also be advantageous since the electronics and sensors for breath sensing may be low cost in large quantities, as the entire inhaler device is preferably disposable for hygienic reasons.

[0016] In a first aspect there is provided an electronic inhaler counter for counting linear actuations of a pressurised metered dose inhaler, pMDI, comprising: a rocker arm including a proximal end providing a pivot and a distal end providing a head; A return spring coupled to the rocker arm pivot; Count switch, Including, In response to a first selected degree of linear drive motion, the rocker arm is arranged to perform a first rocker motion and engage the count switch with the rocker head, and in response to further linear drive motion, the spring is engaged to maintain the rocker head in engagement with the count switch, enabling the rocker arm to perform a second rocker motion. An electronic inhaler counter is provided.

[0017] In some examples, a first selected degree of linear drive motion engages a first portion of the rocker arm with the actuator tongue to swing the rocker arm in a first direction and engage the rocker head with the count switch, and further linear drive motion engages a second portion of the rocker arm to swing the rocker arm in a second direction and maintain engagement of the rocker head with the count switch.

[0018] In some examples, the first rocker motion is a counterclockwise rotation about a pivot axis and the second rocker motion is a clockwise rotation about a count switch.

[0019] In some examples, a first selected degree of linear drive motion does not compress the return spring, and further linear drive motion compresses the return spring. In some examples, this may allow the spring-loaded pivot to remain in a predetermined position until after actuation of the switch, thus providing a well-defined switching point.

[0020] In some examples, the electronic inhaler counter further includes a spring retainer that receives the end of the spring that is not coupled to the pivot, which may allow a longer spring to be used within the device than would otherwise be possible, thus allowing for more overtravel.

[0021] In some examples, the electronic inhaler counter is configured to be mounted to an end of an inhaler canister mounted within an inhaler actuator housing, the linear drive motion is relative to the actuator housing, and the rocker arm is configured to engage an actuator tongue coupled to the actuator housing.

[0022] In some examples, the electronic inhaler counter is configured to fit within at least a portion of the inhaler actuator housing. In some examples, the inhaler device is activated by pressing the electronic inhaler counter against the actuator housing. In some examples, the inhaler device is activated such that at least a portion of the electronic inhaler counter fits within the inhaler actuator housing.

[0023] In some examples, the electronic inhaler counter further includes a digital display. The display may be configured to display the absolute number of linear drives of the inhaler device / exhaled doses counted by the electronic inhaler counter. The display may be configured to display the absolute number of linear drives of the inhaler device / remaining doses. The display may further be configured to display a relative indication of the number of linear drives of the inhaler device / remaining doses. In some examples, the display may provide both a relative and an accurate indication of the remaining number of doses of the inhaler device. The number of linear drives of the inhaler device / remaining doses may be calculated by subtracting the counted absolute number of linear drives of the inhaler device from a predetermined maximum number of linear drives of the inhaler device / doses. The digital display may allow the displayed numbers to be larger relative to the small size of numbers on a mechanical inhaler counter fitted to the inhaler device, which may increase the readability of the display.

[0024] In some examples, the electronic inhaler may be further configured to record inhaler linear drive timestamp data. In some examples, the inhaler linear drive timestamp data may include dose count timestamp data. In some examples, the inhaler linear drive timestamp data may include injection point timestamp data. In some examples, the inhaler linear drive timestamp data may include both dose count and injection point timestamp data.

[0025] The dose count may differ from the inhaler's injection point because the injection point is triggered by the amount of compression of the inhaler container against the actuator body required to deliver a dose of drug, whereas the dose count is triggered by the amount of compression of the inhaler container against the actuator body required for the electronic inhaler counter to count a dose, i.e., act to engage the rocker arm with the count switch. As under-counting is undesirable due to the risk that the user believes there is drug left in the inhaler container when in fact it is empty, the dose count point may be set to be a predetermined amount less than the injection point, thereby effectively avoiding injection without counting.

[0026] In another aspect, an inhaler breath detection module for detecting the start and / or end of an inhalation breath, comprising: the breath sensing module is coupled to an airway of the inhaler; the breath detection module includes sensing means configured to provide a signal indicative of a change in a parameter of the inhaler airway as a function of time caused by an inhalation breath; the breath detection module includes a controller configured to determine the presence of a breath based on a change in a parameter of the inhaler airway as a function of time; An inhaler breath sensing module is provided.

[0027] In some examples, the controller may be further configured to determine a duration of a breath based on changes in the inhaler airway parameter as a function of time. In some examples, the controller is further configured to determine either (i) a confidence of breath initiation and / or termination, or (ii) an estimated flow rate, based on changes in the inhaler airway parameter as a function of time. In some examples, the controller is further configured to determine both (i) a confidence of breath initiation and / or termination, and (ii) an estimated flow rate, based on changes in the inhaler airway parameter as a function of time.

[0028] In some examples, the controller may be further configured to record breath timestamp data. In some examples, the breath timestamp data may include breath start timestamp data. In some examples, the breath timestamp data may include breath end timestamp data. In some examples, the breath timestamp data may include breath start and end timestamp data.

[0029] In some examples, at least a portion of the inhaler breath sensing module is configured to fit within at least a portion of the inhaler actuator housing. In some examples, the inhaler device is actuated by pressing the breath sensing module against the actuator housing. In some examples, when the inhaler device is actuated, at least a portion of the breath sensing module fits within the inhaler actuator housing. In some examples, the inhaler breath sensing module is configured to be attached to an end of an inhaler canister that is mounted within the inhaler actuator housing.

[0030] In some examples, the sensing means is configured to detect a change in a parameter of airflow through a portion of the actuator housing between the actuator housing and the receptacle.

[0031] In some examples, the sensing means may include a pressure sensor. In some examples, at least one differential pressure sensor may be used, with one port connected to a suitable location inside the device and the other port open to atmosphere. In some examples, at least one absolute pressure sensor may be used. In some examples, the at least one absolute pressure sensor may be a small board-mounted barometric pressure sensor. In some examples, two absolute pressure sensors may be used, one measuring atmospheric pressure and the other measuring pressure inside the device. In some examples, a single absolute sensor may be used that measures pressure inside the device and tracks changes in pressure over time. One advantage of using pressure sensors may be that pressure loss readings provide a more direct measure of flow rate and are less susceptible to acoustic noise. One advantage of using at least one absolute pressure sensor may be that they are cheap and small, addressing form factor and cost constraints. One advantage of using differential pressure sensors is that they may be more accurate than absolute pressure sensors.

[0032] In some examples, the sensing means may include a microphone. One advantage of using microphones as sensors may be that they are cheap and small, addressing form factor and cost constraints. Another advantage of using microphones may be that they do not require a tightly sealed port. Another advantage of using microphones may be that they are more accurate at detecting low flow rates than pressure sensors of comparable cost and size.

[0033] In some examples, the inhaler breath sensing module may further include an acoustic feature. In some examples, the acoustic feature may be configured to change a property of the airflow sensed by the sensing means. In some examples, the acoustic feature may include a constriction or restriction through which a portion of the airflow may be configured to flow when a user takes a breath. In some examples, the acoustic feature may include a constriction or restriction in distance between the inhaler breath sensing module and the inhaler actuator housing.

[0034] In some examples, the sensing means is disposed adjacent to the acoustic feature. In some examples where the sensing means includes a microphone, the microphone may be configured to detect sounds generated as air flows through the acoustic feature. In some examples, the acoustic feature may include an orifice coupled to the air passage configured to generate a "jet noise" or whistling sound. In some examples, the acoustic feature may be used to amplify the signal recorded by the microphone, thereby increasing the signal to noise ratio.

[0035] In some examples, the inhaler breath detection module may include a plurality of sensing means each configured to provide a signal indicative of a change in a parameter. In some examples, the plurality of sensing means includes at least two microphones. In some examples, the controller may be configured to perform noise cancellation based on a comparison of the signals indicative of the change in the parameter from the plurality of sensing means. This may improve breath detection accuracy in noisy environments.

[0036] In some examples, the controller is programmed with a machine learning algorithm, and the algorithm is trained using training parameters. In some examples, the training parameters associate the power at each frequency with a different weighting. An advantage of using a machine learning approach may be that the correlation between the microphone sensing signal and flow is improved, especially in different noise environments. This may improve the accuracy of flow and respiration determination in different noise environments.

[0037] In some examples, the controller is configured to process the signal indicative of the change in the parameter into a frequency domain. In some examples, the controller is configured to apply a weighting to the power at each frequency. The weighting may be pre-programmed and is determined by training a machine learning algorithm over a broad data set including inhalation samples and noise samples across a range of flow rates.

[0038] In some examples, the controller is configured to determine a cepstrum of the signal indicative of changes in the parameter. In some examples, the cepstrum may include information about the rate of change of different spectral bands. In some examples, the cepstrum is useful for extracting fundamental frequencies and harmonics.

[0039] In some examples, the controller is configured to perform a linear regression, e.g., to determine an estimate of flow. In some examples, the controller is configured to perform a logistic regression, e.g., to output a confidence of the presence of a breath based on the stored training parameters. In some examples, the confidence of the presence of a breath may be determined relative to the start of a breath and / or the end of a breath. In some examples, the controller is configured to perform both a linear regression, e.g., to determine the flow estimate, and a logistic regression, e.g., to output a confidence of the presence of a breath.

[0040] In some examples, the inhaler breath detection module includes a communication interface. In some examples, the inhaler breath detection module includes a short-range wireless communication interface. In some examples, the controller may be configured to transmit data to a remote device via the short-range wireless communication interface, the data including either (i) a confidence of breath start and / or end, or (ii) an estimated flow rate. In some examples, the controller may be configured to transmit data to a remote device via the short-range wireless communication interface, the data including both (i) a confidence of breath start and / or end, or (ii) an estimated flow rate. In some examples, the short-range wireless communication interface may use Bluetooth® communication. In other examples, other short-range wireless communication interfaces may be used, including but not limited to WiFi, near field communication (NFC), ZigBee, and radio frequency identification (RFID).

[0041] In some examples, the inhaler breath detection module may further include an accelerometer. In some examples, the accelerometer may be configured to detect device orientation. In some examples, the accelerometer may be configured to detect device shaking. In some examples, the accelerometer may be configured to detect both device orientation and device shaking. In some examples, the inhaler breath detection module may be configured to record data of shaking prior to inhalation, for example, 5 seconds prior to inhalation. Recording device shaking may be advantageous to provide data regarding priming of the device prior to an actuation event. For example, in some examples, the inhaler breath detection module may be configured to detect the presence of priming / shaking prior to an actuation event. In some examples, the inhaler breath detection module may be configured to record the duration or intensity of the priming / shaking.

[0042] In another aspect, an inhaler breath detection and analysis system is provided that includes an inhaler breath detection module and an electronic inhaler counter.

[0043] In some examples, the inhaler breath detection and analysis system further includes a housing, and both the inhaler breath detection module and the electronic inhaler counter are disposed within the housing.

[0044] In some examples, the inhaler breath detection and analysis system may be configured to fit within the footprint of existing mechanical inhaler counters, such as those disclosed in WO 2006 / 110080.

[0045] In some examples, the inhaler breath sensing and analysis system is configured to be attached to an inhaler canister.

[0046] In another aspect, receiving a signal from the inhaler breath detection module, the signal including data including at least one of a confidence level of the breath and / or an estimated flow rate of the breath; Post-processing of the data was performed. An inhaler technique feedback app is provided that is configured to provide breathing technique feedback based on at least one of breathing confidence and / or breathing flow rate relative to a predetermined optimal range of use.

[0047] In some examples, the app is configured to calculate breath duration using the confidence of the breath, for example, the app is configured to calculate breath duration using the confidence of the start and end of the breath.

[0048] In some examples, the signal received by the inhaler technique feedback app from the inhaler breath detection module further includes breath duration, breath timestamp data, and / or shaking data.

[0049] In some examples, post-processing procedures may include procedures to correct noisy, inaccurate, or hard-to-use knowledge derived by the algorithm. In some examples, post-processing of the data includes filtering, for example with Gaussian or morphological filters. In some examples, filtering may be used to smooth the data and / or remove outlier "blips." In some examples, post-processing may also include various pruning routines, rule quality procedures, rule filtering, rule combination, model combination, or knowledge integration.

[0050] In some examples, the inhaler technique feedback app may be further configured to receive a signal from an electronic inhaler counter, the signal including data. In some examples, the data may include timestamp data of at least one linear drive of the inhaler. In some examples, the timestamp data of the at least one linear drive of the inhaler may include dose count timestamp data. In some examples, the timestamp data of the at least one linear drive of the inhaler may include injection point timestamp data. In some examples, the timestamp data of the at least one linear drive of the inhaler may include both dose count and injection point timestamp data.

[0051] In some examples, the inhaler technique feedback app may be further configured to provide the user with an indication of how many doses have been administered within a particular time period, e.g., per day. In some examples, the inhaler technique feedback app may be further configured to provide the user with an indication of what time at least one dose was administered. This may help the user track their dosage history, which may be important for the effective management of the user's treatment and / or condition.

[0052] In some examples, the inhaler technique feedback app may: receiving a signal from the inhaler breath detection module, the signal including data including time stamp data of at least one breath; receiving a signal from an electronic inhaler counter, the signal including data including time stamp data of at least one linear actuation of the inhaler; comparing the time stamp data of the at least one breath with the time stamp data of the at least one linear actuation of the inhaler; It may further be configured to provide breathing technique feedback to the user based on the timing of breathing relative to the timing of inhaler actuation.

[0053] In some examples, the inhaler technique feedback app may be further configured to provide the user with an indication of whether the timing of a breath was outside a predetermined time range relative to the timing of the inhaler actuation, for example, whether the breath was too early or too late relative to the inhaler actuation.

[0054] In some examples, the inhaler technique feedback app may be configured to provide technique feedback based on aggregated data and / or long-term usage patterns, which may help users address potential relapse modes of inhaler misuse, such as incorrect timing of delivery / breathing, not inhaling, suboptimal inhalation flow profiles (i.e., too fast or too slow), and / or no breath-hold after inhalation.

[0055] In some examples, the app may be configured to detect if a breath is longer than a predetermined time, e.g., 2 seconds. In some examples, the app may be configured to detect if a breath is taken after injection. In some examples, the app may be configured to detect if a breath flow is maintained below a predetermined flow rate, e.g., 100 l / min. In some examples, the app may be able to detect if a breath is not associated with actuation. In some examples, the app may be able to detect if a breath hold is not associated with actuation.

[0056] In some examples, the app may be configured to receive shaking data from the inhaler breath detection module. In some examples, the app may be able to detect if a priming / shaking of the inhaler was not associated prior to actuation. In some examples, the app may be configured to detect if the duration and / or intensity of the shaking was outside of a predetermined range.

[0057] In another aspect, an inhaler system is provided that includes an inhaler actuation housing, an inhaler canister, and an electronic inhaler counter.

[0058] In another aspect, an inhaler system is provided that includes an inhaler actuation housing, an inhaler canister, and an inhaler breath-sensing module.

[0059] In some examples, the inhaler system includes an inhaler actuation housing, an inhaler canister, an electronic inhaler counter, and an inhaler breath detection module.

[0060] In some examples, the inhaler breath sensing module and / or the electronic inhaler counter are attached to the inhaler canister. In some examples, the inhaler breath sensing module and the electronic inhaler counter are disposed within a breath sensing and analysis system housing, and the breath sensing and analysis system housing is configured to be attached to the inhaler canister.

[0061] In some examples, the inhaler breath sensing module and / or electronic inhaler counter are configured to fit within the footprint of existing mechanical inhaler counters, such as those disclosed in WO 2006 / 110080. In some examples, the breath sensing and analysis system housing is configured to fit within the footprint of existing mechanical inhaler counters, such as those disclosed in WO 2006 / 110080.

[0062] Embodiments of the present disclosure will now be described, by way of example only, with reference to the accompanying drawings, in which: [Brief description of the drawings]

[0063] [Figure 1] 1 illustrates a cross-sectional view of an exemplary electronic inhaler counter. [Diagram 2] 1 shows a schematic flow diagram of a method of using an electronic inhaler counter. [Figure 3A] 1 illustrates an exemplary cross-sectional view of an electronic inhaler counter in use. [Figure 3B] 1 illustrates an exemplary cross-sectional view of an electronic inhaler counter in use. [Figure 3C] 1 illustrates an exemplary cross-sectional view of an electronic inhaler counter in use. [Figure 4] 1 shows a perspective view of an exemplary inhaler assembly including an electronic inhaler counter. [Diagram 5] 1 shows a schematic diagram of an inhaler breath sensing module. [Figure 6A] 1 illustrates an exemplary cross-sectional view of an inhaler breath sensing module mounted within a housing. [Figure 6B] 1 illustrates an exemplary cross-sectional view of an inhaler breath sensing module mounted within a housing. [Figure 7] 1 illustrates an exemplary cross-sectional view of acoustic features and microphone locations within an inhaler breath sensing module mounted within a housing. [Figure 8] 1 shows a schematic flow diagram of a method of signal processing by the inhaler breath detection module. [Figure 9A] FIG. 1 shows a schematic flow diagram of the method and analysis of signal processing by the inhaler technique feedback app. [Figure 9B] FIG. 1 shows a schematic flow diagram of the method and analysis of signal processing by the inhaler technique feedback app. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0064] Electronic inhaler counter 1 shows an exemplary electronic inhaler counter 100 for counting the linear actuation of a pressurized metered dose inhaler (pMDI). The electronic inhaler counter 100 includes a housing 120. The housing 120 is oriented such that its longitudinal axis is parallel to the direction of linear actuation.

[0065] The electronic inhaler counter 100 of FIG. 1 includes a rocker arm 102 in a housing 120, the rocker arm 102 including a proximal end 110 providing a pivot 104 and a distal end 112 providing a head 114. The rocker arm 102 includes an increased thickness portion further including a rigid rocker portion 116 located between the proximal end 110 and the distal end 112 of the rocker arm 102. In the illustrated example, the rocker portion 116 has a dog leg shape including a curved central portion. In other examples, the rocker portion 116 can have other shapes or geometries including a curved central portion to provide a central pivot. The increased thickness portion of the rocker arm 102 including the rocker portion 116 is configured such that the thickness of the rocker arm 102 increases parallel to the transverse direction such that the rocker portion 116 protrudes from the body of the rocker arm 102. The head 114 extends from the distal end 112 of the rocker arm 102 generally parallel to the longitudinal axis of the device 100. In this example, the head 114 has a rounded fillet shape. In other examples, the head 114 may be a different shape, for example, a convex dome or a flat surface. The head 114 preferably has a large surface area and may be located in a portion of the rocker arm 102 of increased thickness. The head 114 is sized to contact the count switch 106.

[0066] The electronic inhaler counter 100 further includes a count switch 106. The count switch 106 is disposed above the rocker arm head 114. The count switch 106 is coupled to an underside of a printed circuit board assembly (PCBA) 124. The PCBA is disposed parallel to the transverse axis of the counter device 100 and is disposed above the rocker arm 102 within the housing 120. The PCBA 124 can be sized to fit within the interior footprint of the housing 120.

[0067] The electronic inhaler counter 100 further includes a pre-compressed return spring 108 that is arranged parallel to the longitudinal axis of the counter device 100 such that the compression axis of the spring 108 is parallel to the direction of the linear drive. One end of the spring 108 is coupled to the rocker arm pivot 104. In this example, the other end of the spring 108 is held by a spring retainer cap 118, with a portion of the spring 108 nested within a cavity of the spring retainer cap. The spring retainer cap 118 is arranged to be parallel to the longitudinal axis of the counter device 100. The spring retainer cap may extend beyond the PCBA 124 and may be held in the housing 120 by a press fit. The advantage of the retainer cap 118 may be that it allows the counter device 100 to use a longer spring than would otherwise be possible, thus allowing for additional overtravel and the ability to provide the necessary force without reaching a solid height. In other examples that do not include a spring retainer cap 118, the end of the spring 108 that is not coupled to the pivot 104 may be coupled to the underside of the PCBA 124 or otherwise directly to the housing 120.

[0068] In a preferred embodiment, the PCBA 124 is powered by a battery (not shown). In some embodiments, the battery is a coin cell battery. In some embodiments, the battery is coupled to a top surface of the PCBA 124, the surface opposite the count button 106.

[0069] In a preferred example, the PCBA 124 is further coupled to a display (not shown). In this example, the display is a digital display. In some examples, the digital display may be an LCD screen. The digital display is located on the top surface of the counter device 100. In other examples, the display screen may be located in other locations on the housing, such as on the side. In this example, the display is secured using a bezel 122 coupled to the housing 120.

[0070] In a preferred embodiment, the housing 120 has an opening 126 on the bottom surface of the counter device 100, below the rocker arm 102, opposite the digital display. The opening 126 is disposed parallel to the transverse axis of the counter device 100. The opening 126 is disposed to expose at least the rocker portion 116 of the rocker arm 102.

[0071] The electronic inhaler counter 100 is arranged such that in response to a first selected degree of linear drive movement, the pre-compressed spring 108 presses against the pivot 104 and the rocker arm 102 performs a first rocker movement until the count switch 106 engages the rocker head 114. In the illustrated example, the first rocker movement is a counterclockwise rotation.

[0072] In response to further linear drive motion, the spring 108 is configured to engage, thereby displacing the pivot 104 and enabling the rocker arm 102 to perform a second rocker motion. In the illustrated example, the spring 108 is compressed, displacing the pivot 104 vertically, which causes the rocker portion 116 of the rocker arm 102 to pivot the rocker arm 102 in a clockwise direction.

[0073] In response to removal of the biasing force, the spring 108 is configured to return to its original configuration and push the pivot 104 down, returning the rocker arm 102 to its original configuration.

[0074] In some examples, the electronic inhaler counter 100 is configured to be mounted on the end of an inhaler canister mounted within an inhaler actuator housing, for example as shown in more detail below in FIG. 3, and the linear drive motion is relative to the actuator housing, with the rocker arm 102 configured to engage an actuator tongue coupled to the actuator housing. In some examples, an increased thickness portion of the rocker arm 102, including the rocker portion 116, is configured to engage the actuator tongue.

[0075] In this example, the rocker head 114 maintains engagement with the count switch 106 during the second rocker movement.

[0076] In this example, the first rocker motion is a counterclockwise rotation about pivot 104. In this example, the second rocker motion is a clockwise rotation of rocker arm 102 about count switch 106, enabled by compression of spring 108.

[0077] The opening 126 of the housing 120 may be configured to receive an actuator tongue of an inhaler device. In some examples, linear drive of the inhaler counter advances the opening 126 over the actuator tongue of the inhaler device. In response to a first selected degree of linear drive motion, at least the rocker portion 116 of the rocker arm 102 contacts the actuator tongue. In response to further linear drive motion, at least the rocker portion 116 of the rocker arm 102 maintains contact with the actuator tongue.

[0078] In the example shown in FIG. 1, in response to a first selected degree of linear drive movement, the rocker portion 116 of the rocker arm 102 is configured to contact an actuator tongue of the inhaler device, thereby causing a first rocker movement.

[0079] In the example shown in FIG. 1, in response to a further linear drive movement, the rocker portion 116 of the rocker arm 102 is configured to pivot at a point of contact with the actuator tongue of the inhaler device during a second rocker movement.

[0080] The electronic inhaler counter 100 must reliably detect when a dose has been expelled from the container. This should be done so as not to add significantly to the force the user must supply to depress the container, for example by adding less than 5N. The mechanism must also allow for significant overtravel so that the switching mechanism does not stop the device from fully actuating the container.

[0081] The force required to register a count is primarily driven by the force required to actuate the switch 106 and the mechanical advantage of the rocker arm 102. The key requirement is that the lever arm pivot 104 is maintained during the first rocker movement until contact with the count switch 106 is made.

[0082] In the example where the first rocker movement is actuated by contact between the locking portion 116 or rocker arm 102 and the actuator tongue of the inhaler actuator body, the pivot 104 may be held down. This may be advantageous by providing a defined switching point. However, the device 100 may also allow significant overtravel, and therefore the pivot 104 is held down by a pre-compressed spring 108. The spring 108 may be further compressed to allow significant overtravel, but may be stiff enough that the pivot 104 does not move until the count button 106 registers a count in response to the first selected degree of linear drive movement.

[0083] 2 shows a schematic flow diagram of a method of using an electronic inhaler counter 200, such as the electronic inhaler counter described in FIG. 1 or FIG. 3A-3C. Starting at step 202, a first selected degree of linear drive motion is applied to the electronic inhaler counter 100. This displaces the rocker arm 102 relative to the inhaler actuator tongue 404 until the rocker portion 116 of the rocker arm 102 contacts the actuator tongue 404. In the example shown in FIG. 3B, in step 204, contact between the rocker portion 116 of the rocker arm 102 and the actuator tongue 404 causes the rocker arm 102 to perform a first rocker motion, with the pivot 104 being held down by the force of the pre-compressed spring 108, and the rocker portion 116 of the rocker arm pivoting the rocker arm 102 until the head 114 of the rocker arm 102 engages the count switch 106 in step 206. In the example shown in FIG. 3B, the pivot 104 is held down and the rocker arm 102 pivots in a counterclockwise rotation until the rocker arm 102 engages the count switch 106 at step 206. In some examples, only a first degree of linear drive is applied and the method ends. In some examples, further linear drive motion is applied to the electronic inhaler counter 100 at step 208. The spring 108 then engages at step 210. In the example shown in FIG. 3C, the spring 108 engages by compressing. Engaging the spring 108 causes the rocker arm 102 to perform a second rocker motion at step 212. In some examples, the second rocker motion is in the opposite direction to the first rocker motion. In the example shown in Figure 3C, the spring 108 compresses and lifts the pivot 104, thereby pivoting the rocker arm 102 in a clockwise rotation about the rocker portion 116 that contacts the actuator tongue 404. In the example shown in Figure 3C, in step 214, the head 114 of the rocker arm 102 maintains engagement with the count switch 106. In some examples, the head 114 of the rocker arm 104 may disengage from the count switch 106 during further linear drive.

[0084] Figure 3A shows an exemplary schematic diagram of an exemplary electronic inhaler counter before an actuation event. Figure 3B shows a first rocker movement 204 of the rocker arm 102 during an actuation event. Figure 3C shows an engagement 210 of the spring 108 and a second rocker movement 212 of the rocker arm 102 during an actuation event.

[0085] FIG. 3A shows an example of an electronic inhaler counter 100. The electronic inhaler counter 100 consists of four molded parts: a two-shot housing 120 with a user button, a two-shot bezel 122 with a transparent window, a rocker arm 102, and a spring retainer cap 118. In this example, the housing 120, bezel 122, and spring retainer cap 118 are made of polybutylene terephthalate (PBT), but other materials can be used in other examples. In this example, the transparent window is made of polycarbonate, but other transparent materials can be used in other examples. In this example, the rocker arm is made of acetal, but other materials can be used in other examples.

[0086] The electronic inhaler counter 100 shown in Figures 3A-3C further includes a spring 108, a battery 128, and a PCBA 124. In some examples, the electronic inhaler counter 100 further includes a soft pad. In the example shown, the electronic inhaler counter 100 includes a soft pad made of Poron foam, although in other examples, other materials can be used. The soft pad may be coupled to the PCBA 124 to protect the circuitry from compressive forces during the linear drive cycle.

[0087] The electronic inhaler counter 100 includes a rocker arm 102 within a housing 120, the rocker arm 102 including a proximal end 110 providing a pivot 104 and a distal end 112 providing a head 114. The rocker arm 102 further includes a rigid rocker portion 116. In the illustrated example, the rocker portion 116 has a dog leg shape. In other examples, the rocker portion 116 can have other curved shapes or geometric shapes to provide the pivot.

[0088] The count switch 106 is disposed above the rocker arm head 114. The count switch 106 is coupled to the bottom surface of a printed circuit board assembly (PCBA) 124.

[0089] In this example, the battery 128 is a coin cell, e.g., a CR2032 battery, but in other examples, other batteries or power sources can be used. The battery 128 is bonded to the top surface of the PCBA 124. In this example, a custom battery clip is used. The clip is surface mounted on the PCBA 124, e.g., by reflow soldering, and comprises a c-clip (positive terminal) and a cross-shaped contact (negative terminal). This design may help to keep the form factor of the electronic inhaler counter 100 within the enclosure of a mechanical inhaler counter (e.g., such as that disclosed in WO 2006 / 110080) and to maintain the overall height. The battery 128 is held vertically by the bezel 122 and a stack of components above the battery. The cross-shaped clip includes two spring-loaded arms that are configured to bend and provide sufficient contact force through the expected range of vertical movement. The surface mounted c-clip restrains the battery 128 along the plane of the PCBA 124 and has four legs that are reflow soldered to the PCBA 124. The inner clip legs make electrical contact to the board and the optional additional outer clip legs serve a purely mechanical function.

[0090] The return spring 108 is positioned with its compression axis parallel to the direction of linear drive. One end of the spring 108 is coupled to the rocker arm pivot 104. In this example, the other end of the spring 108 is retained by a spring retainer cap 118.

[0091] An advantage of the retainer cap 118 may be that it allows the device to use a longer spring than would otherwise be possible, thus allowing for additional over-travel and the ability to provide the necessary force without reaching the solid height. In other examples that do not include the spring retainer cap 118, the end of the spring 108 that is not coupled to the pivot 104 may be coupled to the underside of the PCBA 124 or otherwise directly to the housing.

[0092] The spring retainer cap 118 that houses the spring is positioned to allow the spring to extend beyond the PCBA 124 and is configured to maximize the space available for the spring 108. In this example, the spring retainer cap 118 is press-fit into the housing 120. In other examples, the spring retainer cap may be retained by other means. As a fail-safe against the retainer cap coming loose, the movement of the spring retainer cap 118 is limited by the PCBA 124 above it. The movement of the PCBA 124 is in turn limited by legs that project downward from the bezel 122.

[0093] In this example, a helical coil spring 128 is used that includes three dead coils in the middle to reduce the chance of the spring tangling during assembly. In other examples, other numbers of dead coils may be used in the spring 128. When the electronic inhaler counter 100 is assembled, the spring 128 is pre-compressed to a height set by the space available within the electronic inhaler counter 100. In this example, the spring 128 is pre-compressed to a height of 10.9 mm.

[0094] In the example shown in Fig. 3, the digital display mechanism is provided on the top surface of the counter housing 120. In the disclosed embodiment, the top surface of the housing is provided as a transparent molded window that is held by a bezel 122 to close the housing. In some examples, the counter top surface is further utilized as an actuation surface for actuating the linear drive motion, i.e., for depressing the receptacle counter assembly. As the counter top surface is used as an actuation surface, it is constructed to be rigid and wear resistant as it is subjected to compressive forces and wear during actuation of the inhaler device.

[0095] In response to a first selected degree of linear drive movement, the rocker arm 102 is configured to perform a first rocker movement and engage the count switch 106 with the rocker head 114, and in response to further linear drive movement, the spring 108 is engaged and the electronic inhaler counter 100 is positioned to enable the rocker arm 102 to perform a second rocker movement.

[0096] In response to removal of the biasing force, the spring 108 is configured to return to its original configuration, causing the rocker arm 102 to also return to its original configuration.

[0097] In this example, the electronic inhaler counter 100 is configured to be mounted to the end of an inhaler canister (not shown) mounted within an inhaler actuator housing 402, the linear drive motion is relative to the actuator housing 402, and the rocker arm 102 is configured to engage an actuator tongue 404 coupled to the actuator housing 402.

[0098] In this example, the rocker portion 116 of the rocker arm 102 is configured to engage with an actuator tongue 404 of the inhaler device. In this example, the actuator tongue 404 is positioned to protrude through an opening in the counter housing 120 and engage the rocker arm 102.

[0099] In some examples, as shown in Figure 3B, a first selected degree of linear drive motion causes a first portion of the locking portion 116 of the rocker arm 102 to engage the actuator tongue 404, displace the rocker arm 102 in a first direction, and engage the rocker head 114 with the count switch 106. In some examples, as shown in Figure 3C, a second selected degree of linear drive motion causes a second portion of the rocker portion 116 of the rocker arm 102 to engage the actuator tongue 404, and rock the rocker arm 102 in a second direction.

[0100] In the illustrated example, when the counter 100 attached to the canister is depressed by a user with a linear drive motion relative to the actuator housing 402, the canister valve reaches the injection point after 2.07 mm of travel, which may vary based on the tolerances of the canister valve components. In use, the electronic inhaler counter 100 registers a count early in the canister stroke / linear drive cycle. In the illustrated example, the target separation between the count point and the injection point is 0.78 mm, and tolerance analysis results in an 8 ppm probability of injection before counting.

[0101] In another example, the count-to-injection interval and the associated standard deviation will depend on the tolerances stacked up through the chain and uncertainties associated with the smart assembly process. The largest contributor, in this case, is the uncertainty (0.15mm standard deviation) of the actuator tongue 404 position relative to the electronic inhaler counter 100, through things outside the electronic inhaler counter 100, e.g., the canister and actuator body 402. The main contributors there are uncertainties associated with the smart assembly height and canister stroke for counting.

[0102] In setting the count point early in the travel, the electronic inhaler counter 100 must be protected from inadvertent counting where slight displacements of the canister register as counts. With the interval between counts and puffs in the illustrated example, the chances of the device counting at near zero displacement are extremely small (approximately 10 -13 ) is calculated as follows:

[0103] Thus, when the first rocker movement is actuated by the actuator tongue 404 on the inhaler actuator body 402, the pivot 104 must be held down. However, the device 100 must also allow for significant over-travel and therefore the pivot 104 is held down by a pre-compressed spring 108. The spring 108 can be further compressed to allow for significant over-travel, but is stiff enough that the pivot 104 does not move until the count button registers a count in response to the first selected degree of linear drive movement.

[0104] In this example, the nominal force to hold down the pivot when switching during the first selected degree of linear drive movement is calculated to be 0.77 N, but may be up to 1.27 N (standard deviation 5). Thus, in some examples, 1.27 N is set as the minimum force requirement that the spring must be able to provide after being pre-compressed.

[0105] Other than button actuation, the mechanism needs to support overtravel while not significantly increasing the user force requirement to eject the container (less than a 5N increase). In this example, the spring provides a nominal spare force of 3.13N at container ejection and 5N at maximum container overtravel.

[0106] FIG. 4 shows a schematic example of an inhaler device 400 including an electronic inhaler counter 100 according to the present invention. The inhaler device includes an actuator body 402 with a mouthpiece (through which the medicine is delivered to the user) and a canister counter assembly. In this example, the mouthpiece is covered by a mouthpiece cover 406 configured to be attached to the mouthpiece when not in use for hygienic reasons. In this example, the counter 100 is attached to the end of an inhaler canister (not shown) located in the actuator housing 402. The counter 100 may be attached to the inhaler canister during the assembly process, or in other examples, it may be attached to the inhaler canister at any one of a number of points along the end of the canister opposite the valve, i.e., the portion of the canister opposite the valve stem, from the outermost edge of the counter 100 to its inner base, allowing for various positional variations and various lengths of canister tolerances. That is, the counter may be attached anywhere on the base of the canister. The counter 100 may further be disposed as part of the actuator housing 502 or may be removably attached to the actuator housing 502, for example, to the front or back surface thereof.

[0107] The inhaler device 400 is actuated by depressing the canister counter assembly against the actuator housing 402. The counter 100 is configured to count each actuation of the inhaler device 400 and display the actual status via the display mechanism 124.

[0108] The example of the electronic inhaler counter 100 shown in FIG. 4 includes a digital display 124. In this example, the display mechanism 124 is provided on the top surface of the counter housing 120. In this example, the digital display 124 provides an absolute number of linear drives of the inhaler device / remaining doses and a relative indication of the linear drives of the inhaler device / remaining doses. In this example, the relative indication is provided as a semi-circular bar with a scale length decreasing in proportion to the number of remaining doses of the inhaler device. In this example, the display mechanism 124 further includes a static portion of the display on the bezel 122. In this example, the relative indication of the linear drives of the inhaler device / remaining doses can be compared to the static portion of the display. In this example, the static portion of the display is a semi-circular graduated area. In some examples, at least a portion of the graduated area may be color coded. In this example, the two portions of the graduated area are color coded to indicate when the relative number of linear drives of the inhaler device / remaining doses is low (indicated by yellow in this example) and very low (indicated by red in this example). In other examples, the graduated area may include other color coding systems. In other examples, the graduated area may include an indication of the number of doses remaining in the container.

[0109] The example 100 electronic inhaler counter shown in FIG. 4 further includes a user button 126 disposed on the exterior surface of the housing 120. In some examples, the user button 126 may be used to turn the digital display 124 on / off. In some examples, the user button 126 may be configured to “wake up” the digital display 124. In some examples, this may help extend the battery life of the electronic inhaler counter 100, as the display 124 may be turned off or enter a “sleep” mode to preserve battery life during periods of non-use. In some examples, the “sleep” mode may be activated after a predetermined period of non-use. In some examples, the user button 126 may be configured to switch between display interfaces on the digital display 124. For example, the user button 126 may allow a user to switch between a display showing the number of remaining doses and a display showing the number of linear drives / doses recorded. In some examples, the user button may be configured to activate Bluetooth pairing of the device. In some examples, the user button may be configured to activate Bluetooth pairing of the device when pressed, i.e., pressed and held, for a period of time. In some examples, a user button may be configured to have different functions in response to a press and a long press actuation.

[0110] Inhaler Breath Detection Module 5 illustrates an exemplary inhaler breath detection module 500 for detecting the start and / or end of an inhalation breath. The breath detection module 500 is coupled to an airway 512 of an inhaler 510 and includes a sensing means 502 and a controller 504.

[0111] The sensing means 502 is configured to provide a signal indicative of a change in a parameter of the inhaler airway 512 as a function of time. The controller 504 is configured to receive a signal from the sensing means 502 indicative of a change in a parameter of the inhaler airway 512 as a function of time.

[0112] During use, an inhalation breath taken by a user while the inhaler is operating causes a change in a parameter of the inhaler airway 512. The controller 504 is configured to determine the presence of a breath based on the change in the parameter of the inhaler airway 512 as a function of time.

[0113] In some examples, the sensing means 502 may include at least one pressure sensor. During inhalation, the pressure inside the device will be lower than outside, so by measuring the pressure difference, the flow rate can be calculated and the presence of breathing can be detected. In some examples, at least one differential pressure sensor may be used, with one port connected to a suitable location inside the device and the other port open to atmosphere. In some examples, at least one absolute pressure sensor may be used. In some examples, the at least one absolute pressure sensor may be a small board mounted air pressure sensor, for example an MS5607 air pressure sensor. In a first configuration, two absolute pressure sensors may be used, one measuring atmospheric pressure and the other measuring the pressure inside the device. In a second configuration, a single absolute sensor may be used that measures the pressure inside the device and tracks the changes in pressure over time. In the second configuration, the form factor commitment may be reduced. However, the second configuration may require compensation for pressure changes other than breathing, such as posture changes and air pressure fluctuations. Furthermore, all pressure sensor approaches require a sealed path to the correct measurement location.

[0114] In some examples, the sensing means 502 may include at least one microphone. In some examples, the at least one microphone may be a digital microphone. In some examples, the at least one microphone may be an analog microphone further including a preamplifier circuit and an analog-to-digital converter (ADC). The advantage of a digital microphone may be the reduction and cost over an analog microphone including a preamplifier circuit and an ADC. The microphone may be used to record the sound generated as air flows through an acoustic feature coupled to the inhaler airway. Machine learning algorithms may then be used to determine the presence of a breath (logistic regression) and calculate the flow rate (linear regression). The use of a microphone may overcome the form factor and cost constraints associated with pressure sensors, as well as the requirement for a securely sealed port. However, unlike a pressure sensor, the signal may be subject to errors due to noise and is a less direct measure of flow rate.

[0115] In some examples, the inhaler breath sensing device may include a second microphone, which may be used to provide a "noise cancellation" function by recording ambient noise far from the inhaler cavity, which may improve breath sensing accuracy in noisy environments.

[0116] In some examples, the sensing means 502 may include other sensing means that sense flow, for example, by electromagnetic, optical, mechanical, and / or thermal methods. For the most accurate measurement, the flow sensor requires all flow to be diverted through it, and a fundamental change in the flow path and flow resistance of the existing pMDI device. Another approach is to bleed a portion of the flow through the flow sensor and correlate the reading to the overall flow rate. However, this is very sensitive to the relative flow resistance through the flow meter and the main flow path, as well as the relative amount of bled air. It also requires a well-sealed path to and from the flow sensor.

[0117] With regard to pMDIs, it is generally believed in the literature that a low flow rate is beneficial as it promotes better deposition of the medication in the lungs. Studies have been carried out on inhalation flow rates through pMDIs in practice, taking into account both untrained patients and patients trained to inhale properly (slower) through a pMDI. The results demonstrated that users achieve different inhalation flow rates, but in all cases the flow rates are above 30 l / min. Thus, in some examples, the sensing means may be configured to detect a lower flow rate detection limit of 30 l / min.

[0118] In some examples, the inhaler breath sensing module 500 further includes an acoustic feature. The acoustic feature may be configured to alter the nature of the airflow sensed by the sensing means. In some examples, the acoustic feature may be configured to alter the nature of the airflow such that the signal recorded by the sensing means is amplified. This can reduce susceptibility to noise and increase the signal to noise ratio for more accurate breath and flow sensing at low flow rates.

[0119] In some examples, the acoustic feature comprises a constriction or restriction configured to allow a portion of the airflow to flow when a user takes a breath, hi some examples, the acoustic feature comprises a constriction or restriction in distance between the inhaler breath sensing module and the inhaler actuator housing.

[0120] To amplify the signal recorded by the microphone and increase the signal-to-noise ratio, various whistling mechanisms were identified from the literature and prototyped and tested to characterize their performance. All implementations provided some improvement over the baseline, but the largest improvement was obtained by the introduction of a small side orifice that creates jet noise in the vicinity of the microphone. At low flow rates, the increase is approximately three-fold, and at higher flow rates, a ten-fold amplification is achieved. Thus, in some examples, the acoustic feature may include a side orifice configured to increase the sound pressure inferred at the microphone.

[0121] 6A and 6B show examples where the inhaler breath-sensing module is attached to the housing 612 of the electronic inhaler counter 600. By locating the inhaler breath-sensing module within the electronic inhaler counter housing 612, this may provide the advantage of not increasing the form factor of the device. In some examples, the housing 612 has the same footprint as the hollow housing of the original mechanical counter disclosed in WO 2006 / 110080.

[0122] The microphone 606 is located on a port 614 coupled to a narrow channel 602 arranged parallel to the longitudinal axis. The channel 602 couples the microphone 606 to the airway of the inhaler. A side orifice 604 is located in the channel 602 adjacent to the microphone 606. The side orifice 604 is coupled to the airway of the inhaler. The microphone 606 is further coupled to a printed circuit board assembly (PCBA) 608 that includes a controller. A coin cell battery 610 is also coupled to the top side of the PCBA 608. The PCBA 608 and battery 610 may be configured to be used by both the breath sensing module and the electronic inhaler counter 600.

[0123] Side orifice 604 is an example of an acoustic feature that is configured to increase the sound pressure at the microphone and thus amplify the microphone signal.

[0124] In use, flow from the airway enters through orifice 604 and generates turbulent noise, such as jet noise or whistling, in the vicinity of microphone 606. The airflow is then diverted into channel 602z. In other examples, the acoustic feature may include any other constriction or restriction configured in other ways to allow a portion of the airflow to pass through.

[0125] 7 shows a detailed cross-sectional view of the exemplary breath sensing device of FIG. 6 mounted on a housing 612 of an electronic inhaler counter 600. The housing 612 may be configured to be mounted on an inhaler device. In the illustrated example, the inhaler breath sensing module is configured to be mounted on the end of an inhaler canister mounted in an inhaler actuator housing, for example by the housing 120 as shown in FIG. 4. In this cross-sectional view, a microphone (not shown) is located on a port 614 that is coupled to the main air passage through a small side orifice hole 604 in the housing body 612. In this example, the side orifice 604 has a minimum diameter of 0.4 mm.

[0126] During use, flow from the main air path enters through orifice 604 and can generate turbulent noise in the vicinity of the microphone. The flow is then diverted into channel 602.

[0127] Correlation between microphone readings and flow rate is not as straightforward as pressure readings. The relationship between signal power and flow rate can be obtained empirically, and signal processing can be manually optimized for the frequency range of interest. However, this relationship can change in different noise environments, and optimization requires tuning at each setting.

[0128] In some examples, a machine learning approach may be implemented where the signal from the microphone is processed by the controller using pre-trained parameters. An advantage of using a machine learning approach may be an improved determination of the relationship between the microphone sensing signal and the flow rate, especially in different noise environments. This may improve the accuracy of the flow rate and respiration determination in different noise environments. In some examples, the machine learning algorithm may be trained with inhalation samples and noise samples across a range of flow rates. In some examples, the training parameters associate the power at each frequency with a different weighting. In some examples, the machine learning implementation performs a logistic regression that outputs a confidence of the presence of a breath. In some examples, the machine learning implementation performs a linear regression that outputs an estimate of the flow rate. In some examples, the machine learning implementation performs both logistic and linear regression. In some examples, the output data may be used to detect when a breath starts and / or ends.

[0129] In some examples, the output generated by the machine learning implementation is post-processed, e.g., filtered. In some examples, a Gaussian filter can be applied to smooth the data, and / or a morphological filter can be applied to remove outlier "blips." In some examples, all post-processing and filtering may be performed on a remote device, e.g., an app.

[0130] In one example, Figure 8 provides an overview of how data may be processed by an algorithm. A digital microphone outputs 16 kHz speech data split into 512-bit chunks (corresponding to 0.032 seconds). This data undergoes two transformations, first a fast Fourier transform to obtain the spectrum, then an inverse Fourier transform on the logarithm of the spectrum to obtain the cepstrum. The cepstrum is common in speech analysis because it may contain information about the rate of change of different spectral bands and is useful for extracting fundamental frequencies and harmonics. In this example, a principal component analysis is performed and the top 44 dominant components are extracted. These components are then averaged over the speech input of four consecutive 512-bit chunks, representing 0.128 seconds of data. Five such averages are then grouped together (containing 0.628 seconds of data) for further processing. Each successive group of five averages has an overlap of 0.500 seconds with the previous group (ie, there is a deviation of 0.128 seconds or one average from group to group).

[0131] Continuing with the example shown in FIG. 8, a principal component analysis to extract the dominant components may be performed on each successive group, followed by an operation to calculate a nonlinear product. This nonlinear product constitutes a feature set on which the algorithm performs a linear regression (flow estimation) and a logistic regression (breath detection) separately based on the stored training parameters. Thus, the algorithm outputs an estimate of the flow rate and an estimate of the confidence of the presence of a breath every 0.128 seconds, which corresponds to the time lag between successive data groups. The estimates output by the machine learning algorithm may be transferred to a connected remote device (e.g., a mobile phone), where post-processing (e.g., filtering the data to smooth the data) can be performed. In some examples, all the steps outlined above performed on the PCB of the electronic inhaler counter as well as the grouping, averaging, and conditioning steps of the principal component analysis may be necessary to "compress" the data to a size that can be handled by the controller, e.g., the PCB microcontroller.

[0132] In some examples, the inhaler breath detection module may further include an accelerometer. In some examples, the accelerometer may be configured to detect an orientation of the device. In some examples, the accelerometer may be configured to detect shaking of the device. Shaking may be defined by a change in acceleration greater than a predetermined threshold rate of change. In some examples, the inhaler breath detection module may record data of shaking before inhalation, for example, 5 seconds before inhalation. Recording shaking of the device may be advantageous to provide data regarding priming of the device before an actuation event. For example, in some examples, the inhaler breath detection module may be configured to detect the presence of priming / shaking before an actuation event. In some examples, the inhaler breath detection module may be configured to record the duration or intensity of the priming / shaking.

[0133] feedback 9A shows a schematic flow diagram of a method 900 of signal processing and analysis by an inhaler technique feedback app. Initially, in step 902, the app receives a signal from an inhaler breath detection module, the signal including data. The data may include at least one of a confidence level of the breath and / or an estimated flow rate of the breath.

[0134] In step 904, the app performs post-processing of the data. This step may involve filtering the signal. In some examples, post-processing of the data includes filtering, for example with a Gaussian filter or a morphological filter. In some examples, filtering may be used to smooth the data and / or remove outlier "blips." In some examples, post-processing may also include various pruning routines, rule quality processing, rule filtering, rule combination, model combination, or knowledge integration.

[0135] In some examples, the signal received by the inhaler technique feedback app from the inhaler breath detection module further includes other data, such as breath duration, breath timestamp data, and / or shaking data.

[0136] At step 906, the app is configured to provide breathing technique feedback based on at least one of the breath's confidence and / or the breath's estimated flow rate relative to a pre-determined optimal range of use.

[0137] In some examples, the app is configured to calculate breath duration using the confidence of the breath, for example, the app is configured to calculate breath duration using the confidence of the start and end of the breath.

[0138] In some examples, the app may be configured to detect if a breath is longer than a predetermined time, e.g., 2 seconds. In some examples, the app may be configured to detect if a breath is taken after injection. In some examples, the app may be configured to detect if a breath flow is maintained below a predetermined flow rate, e.g., 100 l / min. In some examples, the app may be able to detect if a breath is not associated with actuation. In some examples, the app may be able to detect if a breath hold is not associated with actuation.

[0139] In some examples, the inhaler technique feedback app may be configured to provide technique feedback based on aggregated data and / or long-term usage patterns, which may help users address potential relapse modes of inhaler misuse, such as incorrect timing of delivery / breathing, not inhaling, suboptimal inhalation flow profiles (i.e., too fast or too slow), and / or no breath-hold after inhalation.

[0140] As shown in FIG. 9B, in some examples, the inhaler technique feedback app may be further configured to receive data from an electronic inhaler counter in step 908, where the signal includes the data. In some examples, the data may include at least one of a dose count and timestamp data related to the dose count and / or an injection point and timestamp data related to the injection point. In some examples, the system may use the recorded data related to the injection point of the inhaler, e.g., the timestamp data, to determine the timing of the inhalation relative to the start and / or end of the breath. This may be used to provide feedback to the user regarding the timing of the delivery / breath, e.g., whether the timing of the breath was outside of a predetermined time range relative to the timing of the inhaler actuation, e.g., whether the breath was too early or too late relative to the inhaler actuation.

[0141] In some examples, the inhaler technique feedback app may be further configured to provide the user with an indication of how many doses have been administered within a particular time period, e.g., per day. In some examples, the inhaler technique feedback app may be further configured to provide the user with an indication of what time at least one dose was administered. This may help the user track their dosage history, which may be important for the effective management of the user's treatment and / or condition.

[0142] In some examples, the inhaler technique feedback app may be further configured to receive device shaking and / or orientation data from the breath sensing module. In some examples, the system may use recorded data, such as timestamps, regarding the inhaler injection point or dose count to determine the shaking technique and / or timing of inhalation relative to shaking. This may be used to provide feedback to the user regarding shaking technique prior to inhalation.

[0143] In some examples, the system may receive the data after each operational event. In some examples, the system may receive the data regarding each operational event during a batch download.

Claims

1. A pressurized metered dose inhaler, an electronic inhaler counter for counting the linear drive of a pMDI, comprising: A rocker arm including a proximal end providing a pivot and a distal end providing a head; A return spring coupled to the rocker arm pivot; A count switch; and In response to a first selected degree of linear drive motion, the rocker arm performs a first rocker motion and is arranged to engage the count switch with the rocker head. In response to a further linear drive motion, the spring is engaged so that the rocker head maintains engagement with the count switch, enabling the rocker arm to perform a second rocker motion. An electronic inhaler counter.

2. The electronic inhaler counter is configured to be attached to an end of an inhaler container attached within an inhaler actuator housing, the linear drive motion being relative to the actuator housing, and the rocker arm is configured to engage an actuator tongue coupled to the actuator housing. The electronic inhaler counter according to claim 1.

3. By the first selected degree of linear drive motion, a first portion of the rocker arm is engaged with the actuator tongue to swing the rocker arm in a first direction, engaging the rocker head with the count switch, and by the second selected degree of linear drive motion, engaging a second portion of the rocker arm to swing the rocker arm in a second direction and maintain the engagement between the rocker head and the count switch. The electronic inhaler counter according to claim 2.

4. The first rocker motion is a counterclockwise rotation about the pivot, and the second rocker motion is a clockwise rotation about the count switch. The electronic inhaler counter according to claim 1.

5. The first selected degree of linear drive motion does not compress the return spring, and the second selected degree of linear drive motion compresses the return spring. The electronic inhaler counter according to claim 1.

6. At least a portion of the inhaler respiration detection module is configured to fit within at least a portion of the inhaler actuator housing. The electronic inhaler counter according to claim 2.

7. The electronic inhaler counter according to claim 2, wherein the inhaler device is actuated by pressing the electronic inhaler counter against the actuator housing.

8. The electronic inhaler counter according to claim 6, wherein at least a part of the electronic inhaler counter is received within the inhaler actuator housing when the inhaler device is actuated.

9. The electronic inhaler counter according to claim 1, further comprising a digital display, the display being configured to display at least one of the count number of the linear drive of the inhaler device and / or the remaining number of the linear drive of the inhaler device, and the remaining number of the linear drive of the inhaler device is calculated by subtracting the count number of the linear drive of the inhaler device from a predetermined maximum number of the linear drive of the inhaler device.

10. An inhaler breath detection module for detecting the start and / or end of an inhalation breath, wherein the breath detection module is coupled to the air passage of the inhaler, the breath detection module includes sensing means configured to provide a signal indicating a change in a parameter of the inhaler air passage as a function of time caused by an inhalation breath, the breath detection module includes a controller configured to determine the presence of a breath based on a change in a parameter of the inhaler air passage as a function of time.

11. The inhaler breath detection module according to claim 10, wherein the controller is further configured to determine the duration of a breath based on a change in a parameter of the inhaler air passage as a function of time.

12. The controller is further configured to, based on a change in a parameter of the inhaler air passage as a function of time, (i) the reliability of the start and / or end of a breath, and (ii) the estimated flow rate The inhaler breath detection module according to claim 10, which is configured to determine at least one of them.

13. The inhaler breath detection module according to claim 10, wherein at least a part of the inhaler breath detection module is configured to be received within at least a part of the inhaler actuator housing.

14. The inhaler device is the inhaler respiration detection module according to claim 10, which is actuated by pressing the respiration detection module against the actuator housing.

15. The inhaler respiration detection module according to claim 14, which depends on claim 13, wherein when the inhaler device is actuated, at least a part of the respiration detection module is received within the inhaler actuator housing.

16. The inhaler respiration detection module according to claim 10, which is configured to be attached to an end of an inhaler container attached within an inhaler actuator housing.

17. The inhaler respiration detection module according to claim 16, wherein the sensing means is configured to detect a change in a parameter of an air flow passing through a part of the actuator housing between the actuator housing and the container.

18. The inhaler respiration detection module according to claim 17, further comprising an acoustic feature portion configured to change the nature of the air flow sensed by the sensing means.

19. The inhaler respiration detection module according to claim 18, wherein the acoustic feature portion includes a constriction or throttle portion configured such that a part of the air flow flows when the user breathes.

20. The inhaler respiration detection module according to claim 19, wherein the acoustic feature portion includes a constriction or throttle portion of distance between the inhaler respiration detection module and the inhaler actuator housing.

21. The inhaler respiration detection module according to claim 10, wherein the sensing means includes a microphone.

22. The inhaler respiration detection module according to claim 21, which depends on claim 18, wherein the microphone is adjacent to the acoustic feature portion.

23. The inhaler respiration detection module according to claim 10, wherein the controller is programmed with a machine learning algorithm, and the algorithm is trained using training parameters that associate power at each frequency with different weightings.

24. The inhaler respiration detection module according to claim 10, wherein the controller is configured to process a signal indicating a change in a parameter in the frequency domain.

25. The inhaler respiration detection module according to claim 24, wherein the controller is configured to apply a weight to the power at each frequency.

26. The inhaler respiration detection module according to claim 10, wherein the controller is configured to determine the cepstrum of a signal indicating a change in a parameter.

27. The inhaler respiration detection module according to claim 10, wherein the controller is configured to perform a linear regression for determining an estimated value of an estimated flow rate and / or a logistic regression for determining the start and / or end of respiration based on stored training parameters.

28. The inhaler respiration detection module according to claim 10, further comprising a short - range wireless communication interface, wherein the controller is configured to transmit, via the short - range wireless communication interface, (i) the reliability of the start and / or end of respiration and / or (ii) data regarding the estimated flow rate to a remote device.

29. The inhaler respiration detection module according to claim 10, comprising a plurality of sensing means each configured to provide a signal indicating a change in a parameter, wherein the controller is configured to perform noise removal based on a comparison of signals indicating a change in a parameter from the plurality of sensing means.

30. The inhaler respiration detection module according to claim 10, further comprising an accelerometer configured to detect the vibration of the device.

31. An inhaler respiration detection and analysis system comprising the inhaler respiration detection module according to any one of claims 10 to 30 and a remote device, wherein the remote device is configured to provide technique feedback based on at least one of the respiration duration and respiration flow rate data from the inhaler respiration detection module.

32. An inhaler respiration detection and analysis system comprising the inhaler respiration detection module according to any one of claims 10 to 30 and a remote device, wherein the remote device is configured to provide technique feedback based on the aggregated data from the inhaler respiration detection module.

33. An inhaler respiration detection and analysis system comprising an inhaler respiration detection module according to any one of claims 10 to 30 and an electronic inhaler counter according to any one of claims 1 to 9.

34. The respiration detection and analysis system according to claim 32, further comprising an inhaler container, wherein the inhaler respiration detection module and the electronic inhaler counter are attached to the container.

35. Receives a signal from an inhaler respiration detection module, the signal including data comprising at least one of respiration reliability and / or estimated flow rate of respiration, Performs post-processing of the data, And provides respiration technique feedback based on at least one of the respiration reliability and / or the flow rate of respiration relative to a predetermined optimal usage range. An inhaler technique feedback application configured as such.

36. The post-processing of the data includes filtering. The inhaler technique feedback application according to claim 35.

37. The inhaler technique feedback application according to claim 35, further configured to provide technique feedback based on aggregated data.

38. The signal received from the inhaler respiration detection module includes time stamp data of at least one respiration, and the inhaler technique feedback application further Receives a signal from an electronic inhaler counter, the signal including data comprising time stamp data of at least one linear drive of the inhaler, Determines the timing of the operation of the inhaler relative to the start and / or end of respiration, And is configured to provide respiration technique feedback to the user based on the timing of respiration relative to the timing of inhaler operation. The inhaler technique feedback application according to claim 35.

39. The inhaler technique feedback application according to claim 38, further configured to provide the user with an indication of whether the timing of the respiration is outside a predetermined time range relative to the timing of inhaler operation.

40. An inhaler operation housing, An inhaler container, at least a portion of the container being configured to be mounted within the inhaler operation housing. An inhaler system comprising the inhaler breath detection module according to any one of claims 10 to 30 and / or the electronic inhaler counter according to any one of claims 1 to 9.

41. The inhaler system according to claim 40, wherein the inhaler breath detection module and / or the electronic inhaler counter is attached to the container.

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