Modular inhaler adherence monitor

Abstract

To provide an adherence monitor for attachment to an inhaler.SOLUTION: An inhaler 10 has a drug canister, an actuator holding the drug canister, the actuator having a mouthpiece, and a dosing device operable to allow the drug canister to be actuated to release a dose. An adherence monitor includes an actuation detection sensor operable to sense the physical movement of the drug canister when actuated. An inhalation data sensor is operable to sense air pressure change created by the inhalation. A controller is coupled to the sensors to record an actuation event.SELECTED DRAWING: Figure 1B

Description

[Technical Field]

[0001] Priority claims This application claims priority to and benefit of U.S. Provisional Patent Application No. 62 / 881,100, filed July 31, 2019, the entire contents of which are incorporated herein by reference.

[0002] Technical Field TECHNICAL FIELD The present disclosure relates generally to inhaler accessories, and more particularly to a modular inhaler compliance monitoring device for monitoring the compliance of an inhaler user. [Background technology]

[0003] Many patients with illnesses are now provided with inhalers that deliver a dosage of medication. For example, an asthma patient may be provided with active medication to support mucus production and reduce inflammation while opening up the respiratory passages. Thus, if a patient's asthma worsens or they continue to take daily maintenance medication to control their symptoms, the patient can place the inhaler in front of their mouth and activate the inhaler spray for symptom relief.

[0004] In the case of a known pressurized metered-dose inhaler (pMDI) inhaler for drug inhalation (e.g., AstraZeneca Symbicort Rapihaler (registered trademark)), the actuator housing at least partially defines a flow path through the inhaler from an air inlet to an outlet. A pressurized metered-dose canister is held by the actuator. The canister includes a valve stem and a throttle valve arranged to be seated within a valve stem block formed on the housing, and the main canister body of the canister is moved relative to the housing and the valve stem to operate the throttle valve and propel a metered dose of a propellant and an active drug agent through the valve stem block and into the flow path. When the user inhales through the mouthpiece of the housing by pressing the canister, air can be drawn into the housing between the canister and the inner wall of the housing and flow through the canister to the outlet. Symbicort Rapihaler (registered trademark) delivers a combination of budesonide and formoterol (a combination of ICS / LABA) for the treatment of asthma and / or chronic obstructive pulmonary disease (COPD). Other types of inhalers can deliver other types of drugs for such diseases and other diseases. Examples of such inhalers include Orion Easyhaler (registered trademark) and Teva Redihaler (registered trademark).

[0005] One major problem is that users often do not operate the inhaler properly, resulting in inefficient drug delivery. For example, the drug may be dispensed from the canister or the mouthpiece may not be held in the proper relationship to the mouth when the user is unable to inhale. Unfortunately, the only effective way to determine whether the user is following the correct technique is to conduct a long-term health status investigation by a healthcare professional after a certain period of use of the inhaler.

[0006] The use of a compliance monitor integrated with the inhaler itself has been proposed, but such a solution is expensive and not a practical solution since inhalers are also designed to be disposable. As another solution, there is the installation of an attachable monitor that can be attached to an existing inhaler (e.g., Symbicort Rapihaler®). However, in the case of Symbicort Rapihaler® and other similar inhalers, their unique shape makes it difficult to physically design such a monitor. Specifically, the minute flexure of the canister occurs significantly relative to the inhaler body. When the flexibility exceeds such an amount of change when the canister is pressed, it becomes impossible to use a limit switch for detecting the operation of the inhaler.

[0007] Furthermore, in the canister of Symbicort Rapihaler®, labels and a dose counter are provided on the front and upper parts, but these cannot be covered by the body of the compliance monitor. Due to these features, it becomes difficult to attach it anywhere other than the body, and in the case of these features, sensing is performed only at the front edge of the canister (where the play amount relative to the inhaler body is minimal). Also, it is necessary to keep the mouthpiece cover that covers a substantial amount of the inhaler exposed. Further, at the lower part of the inhaler, a strap for holding the mouthpiece cover is provided, but this strap also needs to be exposed. As a result, the availability of attachment is further limited.

Summary of the Invention

Problems to be Solved by the Invention

[0008] It is necessary to enable the attachment of a modular compliance monitor for collecting data related to the compliance of the use of an existing inhaler to the existing inhaler. A compliance monitor with a plurality of sensors for determining the operation and inhalation events of the attached inhaler is also required. A modular compliance sensor that does not interfere with the use of the inhaler and does not change the use of the inhaler is also required. A modular compliance sensor for applying a time stamp and inhalation data to the operation event of the inhaler is also required.

Means for Solving the Problem

[0009] As one exemplary embodiment, there is a compliance monitor attachable to an inhaler. The inhaler has a drug canister covered by a canister cover, an actuator for holding the drug canister, and a dosing device operable to actuate the drug canister to release a single dose. The actuator has a mouthpiece. The monitor includes an operation detection sensor operable to sense the physical movement of the drug canister during operation. The monitor includes an inhalation data sensor operable to sense the air pressure change generated due to the inhalation of a single dose from the operation. A controller is coupled to the operation detection sensor and the inhalation data sensor to record the operation event.

[0010] As a further implementation of the exemplary compliance monitor, there is an embodiment that includes an accelerometer coupled to a controller. The accelerometer outputs a signal indicating the movement of the inhaler before actuation. The controller activates the sensor when movement is detected. In another embodiment, the actuation detection sensor is an infrared sensor. In another embodiment, the actuation detection sensor is a contact switch. In another embodiment, the actuation detection sensor is an atmospheric pressure sensor. In another embodiment, the inhaler includes a shield attached to the cannister cover. The actuation detection sensor detects the movement of the shield as an indication of the movement of the inhaler. In another embodiment, the inhalation data sensor is a pressure sensor. The controller determines the pressure profile during a single dose inhalation from the inhaler. In another embodiment, the controller adds a timestamp indicating the movement of the inhaler to the collected data. In another embodiment, the compliance monitor includes a transceiver coupled to the controller. The controller transmits data based on actuation events to an external client device that communicates with the transceiver. Another implementation is an implementation where the external device is a mobile computing device associated with the user. The external device runs an application that analyzes the collected data to determine compliance. In another embodiment, the compliance monitor includes an attachment detection sensor that detects when the inhaler is attached to the compliance monitor. In another embodiment, the compliance monitor includes an actuation button that can be operated by the user to activate the controller and the sensor. Another embodiment, the compliance monitor includes a body that fits and attaches onto the cannister cover of the inhaler. In another embodiment, the inhalation data sensor is positioned on a circuit board so as to be exposed to a gap between the compliance monitor and the cannister cover of the inhaler.

[0011] As another example, there is a compliance monitor attached to an inhaler. The inhaler has a drug cannister and an actuator for holding the drug cannister, the actuator having a cylindrical body with the drug cannister held at one end together with a mouthpiece on the other end, an actuator, and a dosing device attached to the drug cannister. The dosing device includes a front shield surface and is operable to activate the drug cannister to release a single dose. The monitor includes a pair of curved sidewalls that match the sides of the cylindrical body of the actuator. Each sidewall has an open front edge and a closed trailing edge. A side arm is attached to one of the sidewalls so as to overlap the cylindrical body of the actuator. The mouthpiece of the inhaler is accessible and the front shield surface is exposed. An electronic device housing is attached to the closed trailing edge of the sidewall.

[0012] As a further implementation of an exemplary compliance monitor, there are embodiments that include an actuation detection sensor operable to sense physical movement of the drug cannister during actuation. An inhalation data detection sensor senses air pressure changes caused by the actuation. A controller within the electronic device housing is coupled to the sensors to record actuation events. In another embodiment, the inhaler includes a lower strap. Each of these sidewalls includes a lower portion that forms a slot for the strap. In another embodiment, the compliance monitor includes a printed circuit board within the electronic device housing. The printed circuit board has a first surface that includes a connector connected to the actuation detection sensor. The actuation detection sensor is mounted on one of the sidewalls in the vicinity of the shield surface of the inhaler. The circuit board includes a second opposing surface on which the inhalation data sensor is mounted, in the vicinity of a gap between an upper cover of the sidewall and the actuator of the inhaler. In another embodiment, the compliance monitor includes an attachment detection sensor mounted on the first surface of the printed circuit board. This attachment detection sensor is operable to detect attachment of the inhaler to the compliance monitor. In another embodiment, the electronic device housing includes a back panel having an activation button for activation of the controller and the sensors.

[0013] As another example, there is a compliance monitor that can be attached to an inhaler. The inhaler has a drug canister, an actuator that holds the drug canister, and a canister cover that covers the drug canister. The actuator has one end that holds the drug canister together with a mouthpiece at the other end. The drug canister can be activated to release a single dose. The monitor includes a body that fits around and is attached to the canister cover. An electronic device housing is attached to the body. An actuation detection sensor is operable to sense the activation of the drug canister. An inhalation data detection sensor is operable to sense an air pressure change generated due to the actuation. A controller within the electronic device housing is connected to the sensors to record the actuation event.

[0014] A further implementation of the exemplary compliance monitor is an embodiment that includes a printed circuit board within the electronic device housing. The printed circuit board has a first surface together with the actuation detection sensor. The printed circuit board has a second opposing surface where the inhalation data sensor is attached in the vicinity of a gap between the upper cover of the electronic device housing and the canister cover of the inhaler. In another embodiment, the electronic device housing includes a panel having an actuation button operable to activate the controller and the sensors. In another embodiment, the canister cover is physically movable to activate the drug canister. In another embodiment, the actuation detection sensor is a limit switch that activates when the canister cover is moved. In another embodiment, the actuation detection sensor and the inhalation detection sensor are atmospheric pressure sensors.

[0015] The above summary is not intended to represent each embodiment or every aspect of the present disclosure. That is, the above summary merely shows some examples of the novel aspects and features described herein. The above features and advantages, as well as other features and advantages of the present disclosure, will become readily apparent when the following detailed description of representative embodiments and aspects for carrying out the invention is read in conjunction with the accompanying drawings and the appended claims.

[0016] The following description of the exemplary embodiments, taken in conjunction with the accompanying drawings, will enhance the understanding of the present disclosure.

Brief Description of the Drawings

[0017]

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Best Mode for Carrying Out the Invention

[0018] The present disclosure has various modifications and alternative forms. Some representative embodiments illustrated in the drawings will be described in detail below in this specification. However, it should be understood that the present invention is not intended to be limited to the specific forms disclosed, and rather, the present disclosure encompasses all modifications, equivalents, and alternatives within the spirit and scope of the present invention defined by the appended claims.

[0019] The present invention can be embodied in many different forms. Representative embodiments are shown in the drawings and will be described in detail below in this specification. The present disclosure is an example or illustration of the principles of the present disclosure and is not intended to limit the broad aspects of the present disclosure to the illustrated embodiments. Therefore, even if disclosed in sections such as "Summary", "Outline of the Invention", and "Best Mode for Carrying Out the Invention", elements and limitations not specified in the claims should not be incorporated into the claims, either individually or collectively, by implication, inference, or other means. In this specification, unless otherwise specified, the singular form includes the plural form and vice versa. The term "including" means "including but not limited to". Further, in this specification, words representing approximations such as "substantially", "approximately", "essentially", "about" can be used for the purpose of meaning, for example, "exactly", "near", "around", "within 3 to 5% of ~", "within the range of acceptable manufacturing tolerances", or any logical combination thereof.

[0020] The present disclosure relates to a modular compliance attachment intended to monitor the use of an inhaler. As an example, there is a modular compliance attachment intended to monitor the use of the form factor of an AstraZeneca Symbicort® pressurized metered-dose inhaler (pMDI). The physical features included in the compliance monitor surround the inhaler so that the compliance monitor can be attached to an AstraZeneca Symbicort® inhaler.

[0021] Another exemplary modular compliance attachment is intended to monitor the use of the form factor of an Orion Easyhaler® pressurized metered-dose inhaler (pMDI). The physical features included in this compliance monitor engage with the actuator of the inhaler so that the compliance monitor can be attached to an Orion Easyhaler® inhaler to detect the movement of the inhaler.

[0022] Another exemplary modular compliance attachment is intended to monitor the use of the form factor of a Teva Redihaler® pressurized metered-dose inhaler (pMDI). The physical features included in this compliance monitor engage with the cannister cover of the inhaler so that the compliance monitor can be attached to a Teva Redihaler® inhaler.

[0023] In normal use, when the user presses the pMDI canister, a pressurized mist of the drug is released. The patient can inhale the drug directly or through an add-on spacer device. The compliance monitor detects when the user presses the pMDI canister and captures a timestamp of this activation event in the on-board non-volatile (NV) memory. Other inhalation data can be collected and added to the timestamp of the event. Next, the compliance monitor advertises a connection using a transmission protocol (e.g., Bluetooth® Low Energy (BLE)) for establishing a link to a client device (e.g., a smartphone). After the BLE link is formed, the compliance monitor sends any event records (inhalations or heartbeats) to the client device for further analysis of compliance with inhaler use.

[0024] Figure 1A is a perspective view of a known pMDI drug inhaler 10. In this example, the inhaler 10 is a Symbicort® pMDI inhaler manufactured by AstraZeneca, but the principles of the compliance monitor described herein can be employed with any other similar inhaler. The inhaler 10 includes an actuator 12 that holds a pressurized drug canister 14. In the inhaler 10, a dose counter 16 is provided on the actuator 12. The dose counter 16 provides an indication of the remaining number of doses of the drug remaining in the canister 14. The other end of the actuator 12 is formed as a mouthpiece 20. When the inhaler 10 is not in use, the mouthpiece 20 can be covered by a mouthpiece cover 22. When the user presses the dose counter 16, the can ister 14 is pushed to move to the firing position.

[0025] Inhaler 10 also includes a spray stem (not shown) extending from canister 14. This spray stem is adapted to engage a spray directing element (not shown) housed within actuator 12. When canister 14 is pressed and moves into actuator 12, the spray stem and the spray directing element cooperate to deliver a metered single dose of medication through mouthpiece 20 into the user's oral cavity. Ideally, pressing of canister 14 by the user and the user's inhalation occur simultaneously, thereby maximizing inhalation of a single dose of medication.

[0026] Mouthpiece cover 22 ensures that mouthpiece 20 is kept clean and reliably prevents foreign objects from entering mouthpiece 20 when the inhaler is not in use. Mouthpiece cover 20 is attached to the rear of actuator 12 via strap 26, thereby reliably preventing it from accidentally dropping or being lost after cap 24 is removed. The other end of strap 26 is attached to a slot 28 at the rear of actuator 12.

[0027] The cylindrical housing 30 of dose counter 16 includes a shield-shaped downwardly directed surface 32. This surface 32 has a lower edge 34. Lower edge 34 is adjacent to the upper part of mouthpiece cover 22 when attached onto mouthpiece 20. A label 36 is provided at the front of the shield-shaped surface 32. Label 36 may contain information related to the medication contained within canister 14. When mouthpiece cover 22 is on mouthpiece 20, the shield surface 32 blocks movement of housing 30 of dose counter 16 (by preventing downward movement of the lower edge 34 of the downwardly directed surface), thereby preventing firing of inhaler 10.

[0028] The shield 32 directed downward has an aperture (not shown). This aperture is adapted to receive a protrusion (not shown) from the upper edge (not shown) of the actuator 12 in an engaged relationship. When the housing 30 is pressed (for the operation of the inhaler 10), the protrusion extends into the counter housing 30 through the aperture, activating the counter mechanism. The dose counter 16 is preferably permanently attached to the canister 14 so as to avoid a situation where the dose counter 16 is removed from one canister (containing different levels of medicine) to another canister.

[0029] Figure 1B is a perspective view showing the inhaler 10 engaged with an exemplary compliance monitor 100. The compliance monitor 100 collects data regarding the firing of the inhaler 10 and other useful operational data. Figures 2A - 2J show the compliance monitor 100 attached to the inhaler 10. Thus, Figure 2A is a perspective view of the compliance monitor 100 attached to the inhaler 10; Figure 2B is a rear perspective view of the compliance monitor 100 attached to the inhaler 10; Figure 2C is an upper perspective view of the compliance monitor 100 attached to the inhaler 10; Figure 2D is a bottom perspective view of the compliance monitor 100 attached to the inhaler 10; Figure 2E is a side view of the compliance monitor 100 attached to the inhaler 10; Figure 2F is a side view of the opposite side of the compliance monitor 100 attached to the inhaler 10; Figure 2G is a front view of the compliance monitor 100 attached to the inhaler 10; Figure 2H is a rear view of the compliance monitor 100 attached to the inhaler 10; Figure 2I is a top view of the compliance monitor 100 attached to the inhaler 10; Figure 2J is a bottom view of the compliance monitor 100 attached to the inhaler 10.

[0030] Since the compliance monitor 100 is designed to be attached to the inhaler 10, when the medicine supply in the canister 14 runs out, the compliance monitor 100 can be removed and attached to a new inhaler. It can be attached. The compliance monitor 100 is fixed to the actuator 12 of the inhaler 10 via the housing 102. The housing 102 is composed of a material selected to provide mechanical strength and biocompatibility (when contact with the human body is made for a limited duration from the outside). The design of the housing 102 provides a visual cue that serves as a guide when attaching the monitor 100 onto the inhaler 10 to the user. The housing 102 includes a larger opening 104 that fits around the upper portion of the inhaler 10. The housing 102 includes a slot 106 within the base. The slot 106 is aligned with the slot 28 on the inhaler 10 for the cover strap 26.

[0031] Due to the design of the housing 102, the compliance monitor 100 can be engaged in the correct orientation relative to the inhaler, avoiding interference with the use of the inhaler 10. The wide opening 104 fits best at the upper portion of the inhaler 10, and the narrow slot 106 at the lower portion fits fixedly to the base of the inhaler 10. Generally, the shape of the housing 102 is an inverted form of the inhaler housing. To move the compliance monitor 100 to a new inhaler, the compliance monitor 100 can be pulled back from the inhaler 10 to unclip the compliance monitor 100 from the body of the inhaler 10.

[0032] The housing 102 of the compliance monitor 100 includes two generally curved side walls 110 and 112. These curved side walls 110 and 112 are configured to match the outer profile of the mouthpiece 20 of the actuator 14 of the inhaler 10. The lower edges of the two curved side walls 110 and 112 are generally attached to semi-circular lower protrusions 114 and 116. The lower protrusions 114 and 116 each have edges 118 and 120 that hold the bottom of the actuator 14 of the inhaler 10. The edges 118 and 120 form cutouts for accommodating the strap 26 of the inhaler 10. The cutouts formed by the edges 118 and 120 on the rear upper edge of the housing 102 are an imitation of the molding feature of the inhaler 10 and provide the function of anchoring the cover strap 26. The lower halves of the wall portions 110 and 112 form respective closed ends 130 and 132 and opposite semi-circular open ends 134 and 136. The shape of the open ends 134 and 136 is configured such that the user can hold the sides of the mouthpiece 20 of the inhaler 10. On one of the side walls 110, an upper front arm 122 is provided that extends above the front of the actuator 14 of the inhaler 10. The side walls 110 and 112 cooperate with the protrusions 114 and 116 to enclose the actuator 12, while the label 36 is visible and the dose counter 16 is exposed. The protrusions 114 and 116 allow the mouthpiece 20 to be exposed. The slots created by the edges 118 and 120 allow the strap 26 to be positioned. The arm 122 partially surrounds the front of the inhaler 10. Thus, the attachment of the compliance monitor 100 to the inhaler 10 can be performed by slightly flexing the front portions of the side walls 110 and 112 and surrounding the front of the inhaler 10 with the arm 122. Similarly, the removal of the compliance monitor from the inhaler 10 can be performed by moving the arm 122 in the separating direction and sliding the inhaler 10 out from the side walls 110 and 112.

[0033] Side walls 110 and 112 have matching rear ends. These rear ends are each joined to one another and support an electronic device housing 140 that forms the rear portion of the housing 102. As described below, the electronic device housing 140 holds components that collect data from the operation of the attached inhaler 10. The electronic device housing 140 has a pair of side components 142 and 144 attached to each of the side walls 110 and 112. A back panel 146 is attached to the side components 142 and 144. The combination of the back cover 146 and the side components 142 and 144 forms a storage device for electronic components as described below. The back panel 146 includes a transparent auxiliary button 150. In this example, the auxiliary button 150 is illuminated by an LED. These LEDs emit flashes in different sequences in a single color (e.g., green). The auxiliary button 150 may also emit different colors depending on the mode of the compliance monitor 100. The semi-circular upper cover 160 is formed to match the general shape of the actuator 12. As described below, when the compliance monitor 100 engages with the inhaler 10, a gap is created between the edges of the canister 14 by the upper cover 160.

[0034] Figure 3A is a perspective cutaway view showing the inhaler 10 with the attached compliance monitor 100 and shows the electronic components on an internal circuit board 300 mounted within the electronic device housing 140. On the circuit board 300, there is a front face 302 provided with electronic components attached by soldering or other attachment mechanisms. The circuit board 300 includes a battery 310, a piezoelectric vendor circuit 312, a piezo driver circuit 314, a communication module 316, an accelerometer 318, a pair of LEDs 320 and 322, an auxiliary switch 324, and an atmospheric pressure sensor 326 mounted on the front face 302.

[0035] The battery 310 powers the electronic components on the circuit board 300. In this embodiment, the battery 310 is a non-rechargeable (primary) coin-type battery. In this example, the intended battery life is a storage life of 3 years and a subsequent service life of 1 year. An extremely low-power inventory mode is used to maintain battery charging during the storage life period. Of course, a rechargeable battery or other power source may be utilized.

[0036] The piezoelectric buzzer circuit 312 provides user audible feedback from the use of the inhaler 10 and the compliance monitor 100. In this example, the piezo buzzer circuit 312 provides various sounds and instructions (i.e., button press feedback, reminder sounds). The piezo buzzer circuit 312 is amplified by a piezo driver 314.

[0037] In this example, the communication module 316 includes a controller that executes an algorithm for data collection and operation of the compliance monitor 100. The controller also controls the transmission of data to a client device (e.g., an external computing device).

[0038] In this example, the accelerometer 318 is a low-output three-axis accelerometer and is always executed after the end of the inventory mode. The accelerometer 318 is mainly used for power management of the compliance monitor 100. When the sensed acceleration exceeds a predetermined threshold, the compliance monitor 100 exits the sleep mode and turns on the power of the IR sensor on the circuit board 300 as described below. The accelerometer 318 also detects the shaking when the inhaler 10 and the compliance module 100 move sufficiently before inhalation detection. After a programmable amount of inactivity time, the inactivity timer of the accelerometer times out and the compliance monitor 100 enters the sleep mode.

[0039] In this example, the auxiliary button 150 in FIGS. 2A-2B is provided above the auxiliary switch 324. The auxiliary button 150 has multiple functions (e.g., toggling the reminder sound on / off and generating a manual heartbeat event). The auxiliary button 150 is captured between the cover 146 of the housing 140 and the auxiliary switch 324. This enables a user to easily press the button 150 to activate the auxiliary switch 324 and thereby advertise or input various modes designed into the controller firmware to the monitor 100. The actuator on the auxiliary button 150 is made of transparent polycarbonate and functions as an actuator for the auxiliary switch 324 and as an optical pipe for the LEDs 320 and 322. In this example, the LEDs 320 and 322 emit green light and are visible through the auxiliary button 150 on the rear of the cover 146. The LEDs 320 and 322 are used with various flash / strobe combinations to provide feedback to the user about the state of device operation. Both the LEDs 320 and 322 have the same function and are used to generate symmetric illumination of the auxiliary button 150.

[0040] In this example, the atmospheric pressure sensor 326 captures information about the user's inhalation when the user inhales a drug through the mouthpiece 20. The controller attaches the information from the pressure sensor 326 to an event record associated with the inhalation. This additional information may include peak, duration, total amount, and actuation related time. In this example, the atmospheric pressure sensor 326 is disposed adjacent to the top of the circuit board 300 and has access to the lip of the actuator 12 of the inhaler 10. When the user inhales through the mouthpiece 20 of the inhaler 10, a change in the pressure reading can be measured and quantified, providing data about the inhalation profile. The pressure data that may be provided by the atmospheric pressure sensor 326 can be used in the calculation of the inhalation duration (in the case where no inhalation occurs as in the priming event). Using the data from the pressure sensor 326, the peak value can be captured. This peak value is a measurement of the pressure change between the atmospheric pressure and the peak pressure drop that occurred. This is not a calibrated flow rate. Using the data from the pressure sensor 326, the total amount of air inhaled during a dosing event can also be calculated (through the cumulative sum of the instantaneous flow rate over time). Finally, using the data from the pressure sensor 326, the inhalation start can be associated with the movement of the inhaler 10, indicating the time of drug release relative to the start of breathing. Next, this inhalation data is attached to the most recent appropriate actuation event(s). In this way, it becomes possible to associate a single inhalation with multiple actuations or a single actuation. In the case of an event where an actuation is not recorded and a pressure drop is recorded, the inhalation event is indicated, and the data associated with this inhalation event is not captured as a usage event. This data can be transferred with the next heartbeat event or in another event. In this example, since the pressure sensor 326 is activated only when movement is detected, battery consumption is reduced.

[0041] Figure 3B is a perspective view of the rear surface 330 of the circuit board 300. The rear surface 330 mainly shows the electrical traces for the connection of components on the front surface 302 of the circuit board 300 shown in Figure 3A. The rear surface 330 includes an inhaler attachment detection infrared (IR) sensor 332. The rear surface 330 also includes a socket 334 attached to one end of a flexible cable 336. The other end of the flexible cable 336 is attached to a remote drug activation detection IR sensor 338. The activation detection IR sensor 338 is disposed adjacent to the shield 32 of the inhaler 10 when the compliance monitor 100 is attached to the inhaler 10. The cable 336 surrounds the inner surface of the side wall 110 so as to be disposed adjacent to the front of the arm 122 in the vicinity of the edge 34 of the shield 32. The cable 336 is protected by a separate cover. In this example, the inhaler attachment detection IR sensor 332 and the activation detection IR sensor 338 are the same IR sensor circuit.

[0042] The IR sensors 332 and 338 each have an infrared emitter and an infrared receiver that point in the same direction. The receiver cannot sense the light from the emitter unless the emitted light is reflected from another surface. In the process of determining the vicinity of the IR sensor, a power - using read is required, where the infrared emitter is turned on and the receiver value is collected. Second, a non - power - using read is performed, where the infrared emitter is turned off and the receiver value is collected. The difference between these two values is used to determine the proximity of the object to the sensor. If this difference is large, proximity is indicated because something is reflecting IR light onto the receiver. If this difference is small, an open space is indicated because there is nothing reflecting IR light onto the receiver. However, it can be recognized that different types of IR sensors can be utilized. Further, other types of sensors can be used for the detection of attachment and activation according to the following description.

[0043] The remote primary drug activation detection IR sensor 338 is used to determine when the user presses the cannister 14 of the inhaler 10. The activation detection IR sensor 338 detects the proximity of the shield 32 when the cannister 14 is pressed. The activation detection IR sensor 338 is arranged at a position corresponding to the position of the shield 32 when the cannister 14 is pressed enough to release a single dose of the drug. When the shield 32 is pressed and moves downward, it moves in front of the activation detection sensor 338. When pressed and moving downward, it moves in front of the activation detection sensor 338.

[0044] The inhaler attachment detection IR sensor 332 is used to determine whether the inhaler 10 is attached to the compliance monitor 100. As shown in FIG. 3B, the inhaler attachment detection IR sensor 332 is arranged along the center line of the body of the inhaler 10 on the circuit board 300 and detects when the compliance monitor 100 is completely arranged relative to the inhaler 10.

[0045] The inhaler attachment detection IR sensor 332 is powered from a separate microcontroller general-purpose input / output (GPIO) pin from the communication module 316, so that the power of the battery 310 is not permanently depleted due to the inhaler attachment detection IR sensor 332. By supplying power to the inhaler detection IR sensor 332 through a separate pin, sampling from the inhaler attachment detection IR sensor 332 becomes possible (when the compliance monitor 100 is attached to the inhaler 10 for a certain period of time without static power draw).

[0046] The operation of compliance monitor 100 will be described in connection with FIGS. 4 and 5. FIG. 4 is a cross-sectional view related to the compliance monitor 100 with the canister 14 of the inhaler 12 and the actuator 12 attached. FIG. 5 is a front-side cross-sectional view related to the circuit board 300 of the compliance monitor 100 of the shield 32 of the dose counter 12. The event detection algorithm executed by the controller of the compliance monitor 100 depends on the following: a signal from the accelerometer 318 for detecting the movement of the inhaler 10, an inhaler attachment detection infrared sensor 332 for detecting whether the compliance monitor 100 is attached to the inhaler 10, and an actuation detection IR sensor 338 for detecting the drug release from the canister 14. Thus, an event is detected when a signal in a certain order is received. Among these signals, the first signal is from the accelerometer 318 that detects the movement of the inhaler, the next signal is from the inhaler attachment detection IR sensor 332 indicating that the compliance monitor 100 is attached to the inhaler, and the last signal is from the inhaler actuation detection sensor 338 indicating that the drug release has occurred for a sufficient length of time. The atmospheric pressure sensor 326 is used to provide additional information indicating whether inhalation has occurred along with the drug release. The accelerometer 318 can also be used to detect whether the user of the inhaler 10 shakes the inhaler 10 before the drug release for one dose. When the inhaler 10 and the attached compliance monitor 100 are moved, the accelerometer 318 is used to wake up the controller from the sleep mode (low power state).

[0047] When the user inhales through the mouthpiece 20 of the inhaler 10, an air flow indicated by the dashed line 400 is drawn through the inhaler between the actuator 10 and the body 12. The cover 160 of the compliance monitor slightly obstructs this air flow and is designed to create a pressure drop through the gap 402 between the cover 160 of the compliance monitor 100 and the canister 14 of the inhaler 10. The atmospheric pressure sensor (BPS) 326 registers the pressure drop during inhalation, and this signal is recorded by the controller during event recording.

[0048] The IR sensor 338 attached to the flex cable 336 is used to detect when the shield 32 passes over the IR sensor 338. This passage indicates that a single dose of drug has been dispensed from the inhaler 10. As described above, the flex cable 336 follows the inner surface of the side wall 110 and is generally extended by the arm 122. As shown in FIG. 5, the cable cover 510 is mounted mainly on the cable 336 so as to protect the cable 336 and the IR sensor 338. When the user presses the dose counter 16, the cannister 14 of the inhaler 10 moves downward. Thus, the shield 32 moves in front of the motion detection IR sensor 338. Thus, the IR sensor 338 detects the movement of the cannister 14 by detecting the presence and absence of the shield 32. The controller of the compliance monitor 100 on the communication module 316 records the time stamp associated with the RTC and stores the inhalation event in the event queue. If inhalation pressure data is available from the pressure sensor 326, this data is also stored in the inhalation event. The compliance monitor 100 attempts to offload the unsent items in the event queue to a client device (e.g., a mobile device) after detecting that the inhaler 10 has been actuated and storing this information in the event queue. In this example, this transmission is performed via the BLE wireless protocol executed within the communication module 316. The client device notifies the success or failure of the event transmission, and this result is then returned to the controller.

[0049] In this example, after the compliance monitor 100 detects that the inhaler 10 has been actuated and stores this information in the event queue, the compliance monitor 100 attempts to offload the unsent items in the event queue to a client device (e.g., a mobile device). In this example, this transmission is performed via the BLE wireless protocol executed within the communication module 316. The client device notifies the success or failure of the event transmission, and this result is then returned to the controller.

[0050] FIG. 6 is a circuit diagram of the components on the printed circuit board 300. As described above, the communication module 316 functions as the controller of the compliance monitor 100. The communication module 316 includes a main controller 600 and a communication microcontroller 602. The communication module 316 includes a memory 604 used as a firmware and data storage device. In this example, the communication module 316 is a BGM123 It is a Bluetooth (registered trademark) Low Energy (BLE) System in Package (SIP). Of course, any suitable component or set of components may be used for the communication module 316 with appropriate functionality. In this example, the BGM123 BLE SIP includes an ARM M4 microcontroller (main controller 600) and an ARM M0 microcontroller (communication microcontroller 602) that runs a stack compatible with the internal Bluetooth (registered trademark) Smart (registered trademark). In this example, the BGM123 BLE SIP functions as both the main microprocessor of the Bluetooth (registered trademark) radio and compliance monitor 100. In this example, the memory 604 is the embedded flash memory in the BGM123 BLE SIP and stores the firmware executed by the controller 600. A part of this flash memory is also used for storing event records (inhalation & heartbeat) detected by various sensors.

[0051] The BGM123 BLE SIP also includes an embedded SRAM memory used for temporary scratch space and data structures. Several peripheral devices (UART, SPI, A2D, RTC, PWM, DMA, and power management) are used for system drive. The BGM123 BLE SIP is directly driven from the on-board battery 310 and no power regulation other than the internal DC-DC switcher is used for improving the energy efficiency of the system. The module includes an integrated omnidirectional chip antenna 606 that enables the transmission of collected data to an external client device.

[0052] Figure 7 is a state diagram of an operation event detection routine executed by the controller 600 of the compliance monitor 100. The storage state (also known as the inventory mode) 700 is the minimum power mode, where the accelerometer 318 is turned off, the internal clock is not executed, and the compliance monitor does not advertise (transmission or reception via Bluetooth (registered trademark) wireless). In this minimum power state, the only way to wake up the compliance monitor 100 is to press the button 150. The user first receives the compliance monitor 100 in the storage state or inventory mode 700, but after the first interaction between the two, the monitor 100 only returns to the sleep state 704 and does not return to the storage state 700. When a signal indicating the shaking of the inhaler 10 is generated from the accelerometer 318, it proceeds to the inhaler attachment detection reading state 702.

[0053] When the button 150 is pressed, the routine moves to the inhaler attachment detection reading state 702. If a signal from the inhaler attachment detection sensor 332 is not received, the compliance monitor 100 is not attached to the inhaler 10, and the routine moves to the sleep state 704. The sleep state 704 is a low power mode, and the sensors and components are in a low power state. If a signal indicating the attachment of the compliance monitor 100 to the inhaler 10 is not received from the inhaler attachment detection sensor 332, the routine proceeds to the listening state 706. The listening state 706 listens for data from the primary drug administration activation IR sensor 332. Separately, the atmospheric pressure sensor 326 polls and attempts to detect inhalation. If a signal from the inhalation attachment detection sensor 332 is not detected, the routine returns to the sleep state 704. If a signal indicating the attachment of the compliance monitor 100 to the inhaler 10 is not received from the inhaler attachment detection sensor 332, the routine proceeds to the listening state 706. The listening state 706 listens for data from the primary drug administration activation IR sensor 332. Separately, the atmospheric pressure sensor 326 polls and attempts to detect inhalation. If a signal from the inhalation attachment detection sensor 332 is not detected, the routine returns to the sleep state 704.

[0054] In the listening state 706, if the pressure detected by the pressure sensor 326 is lower than the threshold value, the routine shifts to the inhalation state 708. If the pressure detected by the pressure sensor 326 exceeds the threshold value, the routine shifts to the non-inhalation state 710. If the count is less than the threshold value, the routine shifts back to the listening state 706. If the count exceeds the threshold value, the routine shifts to the inhalation data collection state 712. After the timestamp is added to the most recent event, the routine shifts to the event state 714. The event state 714 indicates that one dose of the drug has been released. Next, the routine shifts to the window blank state 716 and then to the listening state 706. The window blank state 716 is used to avoid double-tapping the inhaler 10 or to avoid a situation where a second dose is unexpectedly detected immediately after the drug is released from the cannister 14. The routine avoids accidentally detecting multiple events from some of the shifts that occur during operation. This avoids detecting an event where the fraction of a second window blank exceeds the correct number. After detecting one dose, it returns to the listening state 706. This is because multiple doses can be taken and the routine cannot rely on the user moving the inhaler 10 sufficiently by triggering the accelerometer 318 again to repeat the entire detection cycle.

[0055] In the listening state 706, if the output from the activation sensor 338 exceeds the threshold value indicating activation, the routine shifts to the cannister pressing state 718. If the output signal from the activation sensor 338 is below the threshold value, this indicates that the activation of the cannister 14 has ended and the routine shifts to the release completion state 720. Next, if the count exceeds the threshold value, the routine shifts to the event state 714. If the count is below the threshold value, the routine shifts to the listening state 706.

[0056] Usage events include the timestamp captured from the moment the actuation is detected by the actuation detection IR sensor 338. The duration of the pressing of the canister 14 during actuation is also added to the usage event. If the accelerometer 318 detects shaking before actuation, the shaking intensity and duration of shaking are added to the usage event. If the atmospheric pressure sensor 326 detects inhalation in the vicinity of the actuation time (before, during, or after the actuation time), the peak value of the pressure measurement, the duration of inhalation, and the time between actuation and the start of inhalation are added to the data related to the usage event. All usage events also include battery measurements and temperature measurements captured from the controller on the communication module during actuation.

[0057] Figure 8 is a flowchart of a routine executed by the controller 600 to record the actuation events of the inhaler 10. The flowchart in Figure 8 is a representative example of machine-readable instructions for the collection and analysis of compliance data collected from the compliance monitor 100 in Figure 1B. In this example, the machine-readable instructions include an algorithm executed as follows: (a) a processor; (b) a controller; and / or (c) one or more other suitable processing devices (singular or plural). The algorithm may be embedded in software stored on a tangible medium (e.g., flash memory, CD-ROM, floppy (registered trademark) disk, hard drive, digital video (versatile) disk (DVD) or other memory device). However, those skilled in the art will appreciate that all or part of the algorithm may be executed by a device other than the processor and / or embedded in firmware or well-known manners in dedicated hardware (e.g., this may be an application-specific integrated circuit [ASIC], program It is understood that the programmable logic device [PLD], field programmable logic device [FPLD], field programmable gate array [FPGA], etc. can be executed by individual logic. For example, any or all of the components of the interface can be executed by software, hardware, and / or firmware. Also, some or all of the machine-readable instructions shown by the flowchart may be manually executed. Further, although the exemplary algorithms are described with reference to the flowchart shown in FIG. 8, those skilled in the art can easily understand that many other methods can be used to execute the exemplary machine-readable instructions. For example, the order of executing the blocks can be changed and / or some of the described blocks can be changed, removed, or combined.

[0058] Generally, these components are maintained in the sleep state 704 in FIG. 7 for power saving (800) after the compliance monitor 100 is activated from the storage / inventory state. The routine detects whether to activate the monitor 100 and wait for data from the pressing of the button 150 or data from the signal from the accelerometer 318 (802). When the system wakes up, the controller 600 turns on the power of the components on the compliance monitor (804). The system determines whether the compliance monitor 100 is attached to the inhaler 10 by reading the output of the attachment detection sensor 332 (806). If the inhaler is not attached, the routine loops back to the sleep state (800). If the inhaler is attached, the routine continuously determines whether the inhaler 10 is operating by reading the operation detection sensor 338 (808). If the inhaler has not been operated within a predetermined period, the routine returns to the sleep state (800). When the inhaler is operating, the controller 600 detects the operation via the signal from the operation detection sensor 338 (810). Alternatively, this operation may be based on the detection of the reading value from the pressure sensor 326. Inhalation may also be based on the signal from the operation detection sensor 338 or the pressure sensor 326, or the signals from both may be used.

[0059] The routine collects inhalation data in the form of pressure data from the pressure sensor 326 and attaches this inhalation data to the actuation event along with a timestamp (812). The inhalation data, timestamp, and event data are stored in memory (814). Next, the relevant inhalation data and actuation event data are transmitted to an external device (816).

[0060] Figure 9A is a perspective view of another exemplary known prior art inhaler 900. This prior art inhaler 900 can be attached to a modular compliance monitor that employs the principles described above. In this example, the inhaler 900 is an Orion Easyhaler® inhaler. The inhaler 900 includes a rectangular actuator body 902 having a conical mouthpiece 904. A dust cap 906 is provided to protect the mouthpiece 904 when the inhaler 900 is not in use. A canister cover 908 fits snugly over a canister (not shown) inserted within the body 902. The open upper end in the body 902 allows for the insertion of the canister and the attached canister cover 908. The canister cover 908 can be pressed relative to the actuator body 902, thereby adding pressure to the canister to release the stored drug in a single dose. At the upper portion of the canister cover 908, a button 910 and a series of ventilation portions 912 are provided. The actuator body 902 includes a dose counter 914.

[0061] The operation of the inhaler 900 is initiated by the user shaking the inhaler 900 up and down several times. The user holds the inhaler 900 in an upright position and presses the button 910 with the index finger until a clicking sound is heard. Next, the user releases the index finger, and the drug dose from the canister is ready. The user inhales comfortably at a distance from the inhaler 900 Inhale. Next, the patient attaches the mouthpiece 904 to his or her oral cavity with the lips sealed around the mouthpiece 904. The patient breathes as fast and as deeply as possible until the lungs are full.

[0062] FIG. 9B is a front perspective view showing another example of the modular compliance monitor 950 with the inhaler 900 attached in FIG. 9A. FIG. 9C is a rear perspective view of the modular compliance monitor 950 attached to the inhaler 900. FIG. 9D is a side view of the modular compliance monitor 950 attached to the inhaler 900. FIG. 9E is a side view of the opposite side of the modular compliance monitor 950 attached to the inhaler 900. FIG. 9F is a front view of the modular compliance monitor 950 attached to the inhaler 900. FIG. 9H is a rear view of the modular compliance monitor 950 attached to the inhaler 900. FIG. 9G is a top view of the modular compliance monitor 950 attached to the inhaler 900.

[0063] As will be described, the compliance monitor 950 can record actuation events and corresponding inhalation data from the inhaler 900. The compliance monitor 950 includes a support 960 having a closed upper end 962 and an opposite open end 964. The support 960 has a front wall 966 and an opposite rear wall 968. Two side walls 970 and 972 are joined to the front wall 966 and the rear wall 968. The shape of the support 960 is designed to fit over and around the cannister cover 908 of the inhaler 900 as shown in FIGS. 9B - 9H by inserting the open end 964 onto the cannister cover 908.

[0064] The upper portions of walls 966, 968, 970 and 972 are enclosed by an upper member 974. A series of features 976 of the upper member 974 mimic the feel of the venting features of the inhaler 900. The electronic device housing 980 is snap-fitted to the rear wall 968 to protect these electronic components. The upper portion of the electronic device housing 980 includes a curved portion 982 joined to the upper member 974. The lower portion of the electronic device housing 980 is open and forms a gap 984 with the body 902 of the inhaler 900. A contact member 986 projects from the gap 984. As described below, the monitor 950 is inserted onto the cannister cover 908. Thus, when the patient depresses the monitor 950, the cannister cover 908 is pressed into the body 902 and a single dose of medication is released from the cannister. When the monitor 950 is depressed, the contact member 986 contacts the edge of the body 902. The side wall 972 also includes an auxiliary button 988.

[0065] Figure 10A is a cut-away rear view of the compliance monitor 950 inserted onto the cannister cover 908 of the inhaler 900. Figure 10A shows the internal circuit board 1000 mounted within the electronic device housing 980. The circuit board 1000 is mounted parallel to the rear portion of the cannister cover 908 when the compliance monitor 950 is inserted onto the cannister cover 908. Figure 10B is a detailed view of the front face 1002 of the circuit board 1000. The front face 1002 is adjacent to the rear wall 968 of the monitor 950. Figure 10C is a detailed view of the rear face 1004 of the circuit board 1000. The rear face 1004 is adjacent to the interior of the housing 980.

[0066] The front surface 1002 of the circuit board 1000 has electronic components attached by welding or other attachment mechanisms. Mounted on the circuit board 1000 are a piezoelectric bender circuit 1012, an attachment detection IR sensor 1014, a communication module 1016, an accelerometer 1018, an auxiliary switch 1020, a limit switch 1022, and an atmospheric pressure sensor 1024 mounted on the front surface 1002. The circuit board 1000 includes a battery 1030 and an LED 1032 mounted on the rear surface 1004. The LED 1032 is mounted vertically such that light is directed from the side of the circuit board 1000 through the auxiliary button 988. In this example, since the auxiliary button 988 is made of transparent plastic, the light from the LED 1032 causes the plastic button 988 to emit light, providing feedback to the user. In this example, the communication module 1016 is a BGM123 BLE SIP chip and has the capabilities and functions described above with reference to FIG. 6.

[0067] The battery 1030 powers the electronic components on the circuit board 1000. In this example, the battery 1030 is a coin cell battery. The compliance monitor 950 further uses a low-power inventory mode to conserve battery charge during the shelf life. Of course, a rechargeable battery or other power source may be utilized.

[0068] The piezoelectric bender circuit 1012 provides audible feedback to the user from the use of the inhaler 900 and the compliance monitor 950. The communication module 1016 is similar to the communication module 316 in FIG. 3 and includes a controller. This controller executes an algorithm for data collection and operation of the compliance monitor 950. The controller also controls the transmission of data to a client device (e.g., an external computing device).

[0069] In this example, the accelerometer 1018 is a low-power three-axis accelerometer and is always executed after the end of the initial storage / inventory mode. Similar to the accelerometer 318 described above, the accelerometer 1018 is mainly used for the power management of the compliance monitor 950. The accelerometer 1018 also detects the shaking of the inhaler 900 and the compliance module 950 due to sufficient movement before activation detection.

[0070] In this example, the auxiliary buttons in FIGS. 9C and 9E are arranged above the auxiliary switch 1020. The auxiliary button 988 has multiple functions (e.g., toggling the on / off of the reminder sound, generating a manual heartbeat event, and waking up the monitor 950 from the inventory state). In this example, the LED 1032 emits green light and is used with various flash / strobe combinations to provide feedback (by the illumination of the button 988) to the user about the state of the device operation.

[0071] In this example, the barometric pressure sensor 1024 captures information about the user's inhalation when the user inhales the drug through the mouthpiece 904, similar to the pressure sensor 326 described above. The controller in the communication module 1016 attaches the information from the pressure sensor 1024 to an event record associated with the activation event of the inhaler 900. This additional information may include the peak, duration, total amount, and activation-related time. In this example, the barometric pressure sensor 1024 is arranged near the upper part of the circuit board 1000 and has access to the air reservoir generated by the internal gap between the inside of the compliance monitor 950 and the cannister cover 908 of the inhaler 900. When the user inhales through the mouthpiece 904 of the inhaler 900, the change in the pressure reading value can be measured and quantified, and data about the inhalation profile is provided. Output from the barometric pressure sensor 1024 can provide pressure data, which can be used for the calculation of the duration of inhalation (and in the case of a priming event when no inhalation occurs). Using the data from the pressure sensor 1024, the peak value can be captured. This peak value is a measurement of the pressure change between the atmospheric pressure and the generated peak pressure drop.

[0072] FIG. 11A is a side cross-sectional view showing the compliance monitor 950 with the inhaler 900 attached thereto. FIG. 11B is a detailed broken-away side view of the inhaler 900 and the attached circuit board 1000. The controller in the communication module 1016 operates the compliance monitor 950 according to the routine described above with reference to FIG. 8. When the user presses the upper member 974 of the compliance monitor 950, the cannister cover 908 is pushed down. When the cannister cover 908 is pushed down into the body 902 of the inhaler 900, the contact member 986 attached to the limit switch 1022 is tripped when it contacts the edge of the open end of the body 902 of the inhaler 900.

[0073] Therefore, the tripping of the limit switch 1022 indicates the movement of the inhaler 900. The signal from the limit switch 1022 is processed and added to the event information indicating when the cannister cover 908 is pressed relative to the start of inhalation. The position of the circuit board 100 allows the limit switch 1022 to be positioned at a set distance (e.g., 1 cm) from the body 902 when the cannister cover 908 is in the stationary state. At this distance, the contact member 988 reliably trips the limit switch 1022 by contacting the edge of the body 102 each time the cannister cover 908 is pressed.

[0074] The vent 912 cut into the cannister cover 908 is the key to inhalation detection. When the patient inhales through the inhaler 900, air is drawn through the multiple vents in the inhaler as shown by the orange dashed line 1100 in FIG. 11B. To generate a stable signal during inhalation, a small air reservoir 1110 is designed inside the upper part of the compliance monitor 950. When the compliance monitor 950 is placed on the cannister cover 908, the reservoir 1110 is bounded by an upper surface 974 spaced above the upper part of the cannister cover 908. In this example, a series of rigid plastic ribs 1112 project from inside the upper member 974 and have two functions. One function is to increase the height of the compliance monitor 950 to add an inclination to the electronic device cover 980. This inclination is necessary to reduce the risk that the user of the inhaler 900 will bite into the cannister cover 908 in the inhaler body 902 (by an off - center press). The second function of the ribs 1112 is to increase the size of the air reservoir 1110 between the cannister cover 908 and the compliance monitor 950.

[0075] The atmospheric pressure sensor 1024 is provided inside the air reservoir 1110 to detect the pressure drop during drug inhalation from the inhaler 900. When the user presses down on the compliance monitor 950 and the cannister cover 908, the atmospheric pressure sensor 1024 is activated. When activated, the pressure sensor 1024 begins "listening" for the pressure drop indicating the start of inhalation. A threshold value is set in the firmware algorithm executed by the controller in the communication module 1016 for filtering out false signals.

[0076] The attachment detection IR sensor 1014 mounted on the front 1002 of the circuit board 1000 detects when the compliance monitor 950 is attached to the inhaler 900. Similar to the compliance monitor 100, the compliance monitor 950 is mainly held in a low-power sleep state. The accelerometer 1018 is used to wake the monitor 950 from this mode and to detect the shaking of the inhaler 900. When the compliance monitor 950 is awakened, the infrared sensor 1014 gates further sensing according to the device state. When the sensor 1014 detects that a face is in the vicinity (which indicates that the compliance monitor 950 is attached to the inhaler 900), a further sensing mechanism is activated.

[0077] Figure 12A is a state diagram of the usage detection of the inhaler 900. The storage state (also known as the inventory mode) 1200 is the minimum power mode. In this state, the accelerometer 1018 is turned off, the internal clock is not executed, and the compliance monitor does not advertise. In this minimum power state, the only way to wake the compliance monitor 100 and proceed to the detection state 1202 is either to activate the limit switch 1020 by pressing the auxiliary button 988 or to activate the limit switch 1022 by depressing the cannister cover 908. The user first receives the compliance monitor 950 in the storage state or inventory mode 900, but after the first interaction between the two, the monitor 950 only returns to the sleep state 1204 and does not return to the storage state 1200.

[0078] After the auxiliary button 988 is pressed to end the save / inventory state 1200 and proceed to the detection state 1202, the attachment detection IR sensor 1014 is tested. The signal from the attachment detection IR sensor 1014 is measured to determine whether the monitor 950 is attached to the inhaler 900. If it is determined that the monitor 950 is not attached to the inhaler 900, the monitor 950 proceeds to the sleep state 1204. If the monitor 950 is attached to the inhaler 900, the controller proceeds to the listening state 1206, the atmospheric pressure sensor 1024 is activated, and the timer is started. In this example, the pressure sensor 1024 starts data collection at a rate of 10 Hz and maintains a moving average of the atmospheric pressure. If the variation from the moving average of the pressure exceeds a configurable pressure activation threshold, it enters the inhalation state 1208 and the moving average is fixed at the current value. As long as the pressure sensor value is maintained at least at a configurable hysteresis value below the pressure activation threshold value, the algorithm remains in the inhalation state 1208. After the pressure drops below a lower threshold and the number of inhalation samples exceeds a configurable duration threshold, it enters the inhalation completion state 1210. The inhalation event is recorded as the event state 1212. Next, the monitor 950 starts advertising the inhalation event 1214 and returns to the sleep state 1204. If the measured duration is below the duration threshold, the algorithm returns to the listening state 1206. If no event is detected after a configurable timeout period after the pressing of the limit switch 1022, the algorithm stops measuring for the event and returns to the sleep state 1204.

[0079] Usage events include the timestamp captured from the moment the activation is detected by the motion detection IR sensor. The duration of the pressing during activation is also added to the usage event. If the accelerometer detects shaking before activation, the shaking intensity and duration are added to the usage event. If the atmospheric pressure sensor detects inhalation in the vicinity of the activation time (before, during, or after the activation time), the peak value of the pressure measurement, the duration of the inhalation, and the time from the start of inhalation to the inhalation peak are added to the usage event. All usage events also include the battery measurement and temperature measurement captured from the controller during activation.

[0080] Figure 12B is a state diagram of shake detection. The movement of the accelerometer is monitored, and when this movement reaches a predetermined threshold value (which indicates the occurrence of shaking), the amount of samples exceeding the shake threshold is counted, and the data is attached to the inhalation event packet. If the captured shake data does not occur within the specified time frame leading to the inhalation event, it expires.

[0081] The shake detection algorithm is executed by the controller in the communication module 1016. The controller starts from the low-power save mode 1250. As described above, when the limit switch 1022 is activated by pressing the auxiliary button 988 (by depressing the cannister cover 908), the routine ends the low-power save mode 1250 and proceeds to the monitor detection state 1252. After waking up from the save / inventory state 1200, the attachment detection IR sensor 1014 is measured to determine whether the compliance monitor 950 is attached to the inhaler 900. If the compliance monitor 950 is not attached to the inhaler 900, the monitor enters the low-power sleep state 1254. After the auxiliary button 988 is pressed, the attachment detection IR sensor 1014 is tested. If it is determined that the monitor 950 is not attached to the inhaler 900, the monitor 950 returns to the sleep state 1254. If the monitor 950 is attached to the inhaler 900, the controller proceeds to the listening state 1256.

[0082] When the monitor 950 is attached to the inhaler 900, the accelerometer 1018 is configured for active measurement and a timer started in the listening state 1256. When the magnitude of the acceleration vector exceeds a configurable movement activity threshold, the sway state 1258 is entered. The algorithm continuously measures the accelerometer in the sway state 1258 as long as the magnitude of the accelerometer vector does not fall below the configurable movement activity threshold for a configurable number of samples. After the magnitude of the accelerometer vector returns below the activity threshold, if the number of sway samples exceeds the configurable threshold of sway samples, this sway is considered ended and the routine moves to the completed state 1260. Next, the sway data is saved (1262) and then included during the next detected usage event. Next, the algorithm returns to the sleep state 1254. If the measured number of sway samples is below the threshold of sway samples, the monitor 950 returns to the listening state 1256. If a configurable timeout period occurs after the movement of the accelerometer is detected without sway detection, the algorithm stops the sway measurement and returns to the sleep state 1254. If the number of sway samples exceeds the configurable threshold of sway samples, this sway is considered ended and the routine moves to the completed state 1260. Next, the sway data is saved (1262) and then included during the next detected usage event. Next, the algorithm returns to the sleep state 1254. If the measured number of sway samples is below the threshold of sway samples, the monitor 950 returns to the listening state 1256. If a configurable timeout period occurs after the movement of the accelerometer is detected without sway detection, the algorithm stops the sway measurement and returns to the sleep state 1254.

[0083] Figure 13A is a perspective view of another type of known prior art inhaler 1300. In this example, the inhaler 1300 is a Teva Redihaler®. The inhaler 1300 includes an actuator body 1302, a cylindrical mouthpiece 1304, a canister cover 1306, and a pivoting cap 1308 (shown in the open position). The pivoting cap is attached on a pivot point 1310 to rotate from the open position to the closed position to cover the mouthpiece 1304. The canister cover 1306 includes an upper cover 1312 together with a vent 1314.

[0084] In this example, the user of the inhaler 1300 rotates the cap 1308 to the open position to expose the mouthpiece 1304. Next, the user takes a deep breath. Next, the user places the mouthpiece 1304 into his or her oral cavity and inhales deeply to release the drug from the canister in the canister cover 1306. The inhaler 1300 has a membrane (not shown). This membrane is opened by inhalation to release the drug from the canister.

[0085] FIG. 13B is a front perspective view of another exemplary type of modular compliance monitor 1350 attached to the inhaler 1300 shown in FIG. 13A. FIG. 13C is a rear perspective view of the modular compliance monitor 1350 attached to the inhaler 1300. FIG. 13D is a side view of the modular compliance monitor 1350 attached to the inhaler 1300. FIG. 13E is a side view of the opposite side of the modular compliance monitor 1350 attached to the inhaler 1300. FIG. 13F is a front view of the modular compliance monitor 1350 attached to the inhaler 1300. FIG. 13H is a rear view of the modular compliance monitor 1350 attached to the inhaler 1300. FIG. 13G is a top view of the modular compliance monitor 1350 attached to the inhaler 1300.

[0086] The support 1360 included in the compliance monitor 1350 has an open upper end 1362 and an opposite open end 1364. The support 1360 has a curved front wall 1366 and an opposite curved rear wall 1368. The two side walls 1370 and 1372 are joined to the front wall 1366 and the rear wall 1368. The shape of the support 1360 formed by the walls 1366, 1368, 1370 and 1372 is designed to fit over and around the canister cover 1306 of the inhaler 900 as shown in FIGS. 13B-13H.

[0087] The walls 1366, 1368, 1370, and 1372 completely surround the inhaler 1300, exposing the upper cover 1312 and the ventilation part 1314. The rear wall 1368 includes a thumb push tab 1378 at the bottom to assist in removing the compliance monitor 1350 from the inhaler 1300. When pressed, the monitor 1350 is pulled upward relative to the inhaler 1300.

[0088] The side wall 1372 supports the electronic device housing 1380. The electronic device housing 1380 is formed from a front wall 1382 and a rear wall, and adjacent side walls 1386. The side wall 1386 has an upper panel 1388 that includes an interface button 1390. Similar to other exemplary compliance monitors, the interface button 1390 can be pressed to activate different functions. The cover 1392 extends from the side wall 1372 and encloses the electronic components within the housing 1380.

[0089] FIG. 14A shows the front face 1402 of a circuit board 1400 mounted within the electronic device housing 1380 in FIGS. 13B - 13H. FIG. 14B shows the rear face 1404 of the circuit board 1400. The front face 1402 and the rear face 1404 of the circuit board 1400 have electronic components attached by soldering or other attachment mechanisms. The circuit board 1400 includes a battery 1410, a piezoelectric vendor circuit 1412, a communication module 1416, an accelerometer 1418, an auxiliary switch 1420, and an LED 1422 mounted on the front face 1402. The circuit board 1400 includes a mounting detection IR sensor 1424 and an atmospheric pressure sensor 1426 mounted on the rear face 1404.

[0090] The battery 1410 powers the electronic components on the circuit board 1400. In this example, the battery 1410 is a coin cell battery. The compliance monitor 1350 has an even lower power inventory mode. This even lower power inventory mode is used to maintain battery charge during the shelf life. The piezoelectric vendor circuit 1412 provides user audible feedback from the use of the inhaler 1300 and the compliance monitor 1350. The communication module 1416 is similar to the communication module 316 in FIG. 3 and includes a controller that executes an algorithm for data collection and the operation of the compliance monitor 1350 according to the flowchart in FIG. 8. The controller also controls the transmission of data to a client device (e.g., an external computing device).

[0091] In this example, the accelerometer 1418 is a low power three-axis accelerometer and is always executed after the end of the initial storage / inventory mode. The accelerometer 1018 is mainly used for power management and also detects the shaking of the inhaler 1300 and the compliance monitor 1350 if there is sufficient movement for operation detection.

[0092] In this example, the interface button 1390 in FIGS. 13B and 13E is disposed above the auxiliary switch 1420. The LED 1422 causes the interface button 1390 to emit light, and the LED 1422 can be turned on and off to indicate different states. The interface button 1390 has multiple functions (e.g., toggling the on / off of the reminder sound, waking the compliance monitor 1350 from the storage state, and generating a manual heartbeat event).

[0093] In this example, atmospheric pressure sensor 1426 captures information about the user's inhalation as they inhale medication through mouthpiece 1304, similar to pressure sensor 326 described above. A controller in communications module 1016 attaches information from pressure sensor 1426 to an event record associated with inhaler actuation event 1300. This additional information is similar to the pressure sensors in the other exemplary inhalers described above.

[0094] Figure 15A is a side cross-sectional view of the circuit board 1400 when the compliance monitor 1350 is inserted onto the canister cover 1306. Figure 13B is a detailed front cross-sectional view of the circuit board 1400 when the compliance monitor 1350 is inserted onto the canister cover 1306. Figure 15C is a detailed side view of the pressure sensor 1426 associated with the air vent 1314 of the inhaler 1300. As can be seen in Figure 14B, an attachment detection IR sensor 1424 is located on the rear surface 1404 of the circuit board 1400 between the circuit board 1400 and the canister cover 1306. The attachment detection IR sensor 1424 detects when the compliance monitor 1350 is inserted onto the canister cover 1306 of the inhaler 1300.

[0095] When a large pressure drop occurs within the inhaler 1300 due to inhalation, the pressure drop is indicated by dashed line 1500. As shown, air is drawn in (through a vent 1314 in the top cover 1312 of the inhaler 1300). A series of ribs 1510 extend from the inside surface of the cover 1392 and connect to the vent 1314 of the inhaler 1300. These ribs 1510 create a passageway (indicated by dashed line 1512) connecting an atmospheric pressure sensor 1426 to the vent 1314 in the inhaler to take advantage of the Venturi effect during inhalation. The resulting pressure drop is registered by the nearby atmospheric pressure sensor 1426 on top of the circuit board 1400.

[0096] FIG. 16 is a state diagram of a detection algorithm used by a controller on communication module 1416 in this example. The controller starts in low power save mode 1600. As described above, when limit switch 1320 is activated by pressing button 1390, low power save mode 1600 ends and monitor detection state 1602 is entered. The controller in monitor detection state 1602 wakes up attachment detection IR sensor 1424. When woken up, IR sensor 1424 gates further sensing depending on the state. If IR sensor 1424 does not detect a neighboring surface (which indicates that monitor 1350 is not attached to inhaler 1300), the routine proceeds to sleep state 1604. Similar to other exemplary compliance monitors, compliance monitor 1350 is mainly in a low power sleep state 1604. Accelerometer 1418 is used to wake compliance monitor 1350 from sleep state 1604 and to detect shaking of inhaler 1300. Pressing button 1390 to activate auxiliary switch 1420 also wakes compliance monitor 1350.

[0097] When the IR sensor 1424 detects a nearby surface (which indicates that the compliance monitor 1350 is attached to the inhaler 1300), the routine proceeds to the listening state 1606. The barometric pressure sensor 1426 is activated and a timer is started. In this example, the pressure sensor 1426 listens for a pressure drop indicating the start of actuation and inhalation. A threshold value is set within the firmware algorithm to filter out false signals. In this example, the barometric pressure sensor 1426 starts collecting data at a rate of 10 Hz and maintains a moving average of the ambient pressure. When the variation from the moving average of the pressure exceeds a configurable pressure activation threshold, the inhalation state 1608 is entered and the moving average is fixed at the current value. The algorithm remains in the inhalation state 1608 as long as the value from the pressure sensor 1426 remains within a configurable hysteresis value that is at least below the pressure activation threshold. After the pressure returns to a value below the lower threshold and the number of inhalation samples exceeds a configurable duration threshold, the inhalation complete state 1610 is entered. The inhalation event is recorded in the event state 1612. The event is advertised in the advertise state 1614. Next, the monitor 1350 returns to the listening state 1606. If no event is detected after a configurable timeout period after actuation, the algorithm stops measuring the event and returns to the sleep state 1604.

[0098] The usage event includes a timestamp captured from the moment the barometric pressure sensor 1426 detects actuation. If the accelerometer 1418 detects shaking before actuation, the shaking intensity and duration are added to the usage event. If the barometric pressure sensor 1426 detects inhalation in the vicinity of the actuation time (before, during, or after the actuation time), the peak value of the pressure measurement, the duration of the inhalation, and the time from inhalation start to inhalation peak are added to the usage event. All usage events also include battery measurements and temperature measurements captured from the controller during actuation.

[0099] The exemplary compliance monitors 100 in FIG. 1B, 950 in FIG. 9B, and 1350 in FIG. 13B are modular and can be attached or removed from their respective inhalers, although it is understood that components of the exemplary compliance monitors can be integrated with an inhaler (e.g., inhaler 10 in FIG. 1A, inhaler 900 in FIG. 9A, or inhaler 1300 in FIG. 13A). This should be. The principles described herein may be incorporated into other types of modular compliance monitors or integrated with other types of inhalers.

[0100] As described above, each of the exemplary compliance monitors collects data regarding inhaler operation and provides a timestamp and other relevant data. The collected data includes inhaler operation events including a unique identifier, the timestamp of the event, the ambient temperature, and the sensor battery level. The controller for each exemplary compliance monitor also collects the number of awakenings and the duration of awakenings. The number of awakenings and the duration of awakenings are useful in estimating battery life and determining whether dose sensing is being performed correctly. The controller also collects several additional flags (e.g., whether the attached inhaler has been moved within the last 24 hours, whether the inhaler is attached to a drug, and whether the inhaler is held in the correct orientation as determined by each accelerometer).

[0101] Thus, an exemplary data record may take the format as follows: "Event 1, 4:00 PM, July 25, 2019, 21C, 2.9V, 2 awakenings, 90 seconds of awakening, movement, medium level". Additionally, based on the knowledge of the type of sensor and the association with the drug via the user interface by the user, the drug may be known and added to the data record by an external device or an external server that receives data from the compliance monitor. Further data (e.g., dosage number) may also be attached to the data record by the external device or the external server. Finally, additional sensor-specific data is collected by the individual sensors. An exemplary compliance monitor collects the duration and intensity of the shake of the drug before use. As described above, the atmospheric pressure sensor enables the collection of the peak value and the duration of inhalation. Exemplary compliance monitors 950 and 1350 collect the peak time as the difference between the start of inhalation and the peak value and the total amount of inhalation. Compliance monitor 100 captures the time between activation (when the drug is released) and the start of inhalation and the number of seconds the drug actuator is pressed. With this data, a healthcare provider can determine whether a patient is using their drug as instructed with the appropriate inhalation technique. By evaluating the trend of this data, the healthcare provider can provide instructions for more effective use of drug administration or determine that a change in treatment is necessary. <![CDATA[

[0102] ]] As another example of the measurement of data collected by an exemplary compliance monitor, there is a first second volume. The first second volume is the volume in the first part of the inhalation, is most relevant to the inhalation, and provides a more complete picture of the inhalation profile. The first second volume refers to the volume inhaled at the initial sample of the inhalation (after reaching the threshold). After the start of the inhalation detection algorithm (gate opened and closed by movement detection for the Symbicort inhaler 10 in FIG. 1A by the Redihaler inhaler 1300 in FIG. 13A or by the limit switch for the Easyhaler inhaler 900 in FIG. 9A), the atmospheric pressure sensor first collects a baseline (by capturing several samples and averaging them). In this example, when the atmospheric pressure sensor captures a new reading every 100 ms, this baseline is continuously updated with the new readings and a moving average is maintained. If the drop in the pressure reading exceeds half of the preset threshold, subsequent readings do not contribute to the moving average. When the pressure reading drops to the threshold, inhalation is considered to have started.

[0103] The first second volume is the sum of the pressure differences from the baseline for the first 10 samples (1 second) after reaching the threshold. As an example, if the moving average of the baseline pressure is moving slightly around 98000 Pascals and the threshold is 16, at the start of the user's inhalation, if the pressure reading drops below half of the threshold (97992), it does not contribute to the moving average, and if the pressure reading drops below 97984, it is counted as the start of inhalation. This is done so that the moving average is not adjusted when the inhalation is slow (which would cause difficulty in reaching the threshold). This also allows the system to be adjusted to natural environmental pressure changes (e.g., altitude changes).

[0104] Most inhalations start with a strong breath and then slowly taper off after reaching a peak. Using this measurement, it is also possible to determine a more accurate representation of the breathing profile. Since patients typically also dispense drug delivery from the inhaler within the first second of inhalation, this measurement enables the collection of additional data relevant to the most important part of inhalation. If the user dispenses drug delivery from the inhaler within the first second and the breathing at that time is slow or rising slowly, the volume in the first second can assist in diagnosing the state where the patient is not properly timing their own breathing.

[0105] The data collected by the compliance monitor can be live data, and all sensor values are streamed via a Bluetooth® connection to a remote device (e.g., a smartphone). This enables the use of the compliance monitor for collecting more data about the patient's inhaler technique and allows for the training of the patient regarding the proper use of the inhaler.

[0106] The data transmitted in the live data feature is listed below: the status of each button on the compliance monitor, the physical orientation of the inhaler in three dimensions, a boolean value indicating whether the orientation is correct for the inhaler, a boolean value indicating whether the inhaler is attached to the drug delivery canister, a boolean value indicating whether the inhaler is shaking, a boolean value indicating whether the sensor is currently detecting an inhalation, as well as the current pressure reading and the pressure baseline. Thus, in the exemplary compliance monitor 100 in FIGS. 2-5, the orientation of the inhaler 10 can be determined by the accelerometer 318, whether the inhaler 10 is attached to the compliance monitor 100 can be determined by the attachment detection IR sensor 332, and the pressure and baseline pressure can be determined by the atmospheric pressure sensor 326.

[0107] This data is transmitted at regular intervals. The controller of the compliance monitor can be programmed to determine whether the current data is different from the data collected in the previous interval. If the data is the same, the controller saves battery power by not performing an update transmission.

[0108] Live data can be used to evaluate whether appropriate techniques are being adhered to. The technique in the use of a particular inhaler can be evaluated by live data. For example, the data can indicate that a compliance monitor is not attached to the inhaler. This live data can indicate whether the compliance monitor is in the correct orientation (for the delivery of a single dose). This live data can indicate whether the user is inhaling and, if the user is inhaling, can indicate the inhalation intensity. This live data can also indicate whether the user's inhalation is being performed with appropriate metrics (e.g., duration, intensity, and actuation timing that can achieve good deposition of drug administration). Further analysis can also indicate whether the user has deviated from a typical inhalation profile, which can indicate the imminence of relapse or the improvement or deterioration of the user's condition).

[0109] Live data can be used to determine whether a particular inhaler model has first been shaken (or not shaken in the case of the Redihaler inhaler 1300 in FIG. 13A). For example, when the compliance monitor 1350 is awakened through motion detection, a shake detection algorithm is turned on. The algorithm periodically monitors the accelerometer 1418 and calculates the magnitude of the acceleration. If the magnitude reaches a threshold and this threshold is maintained for a minimum period, shaking is in progress. Live data includes the accelerometer values and a binary value indicating whether the compliance monitor 1350 is shaking or not.

[0110] As another example, the Easyhaler inhaler 900 in FIG. 9A may be primed. Live data includes a binary value of the state of the limit switch 1022 on the Easyhaler inhaler compliance monitor 950. When the actuator on the inhaler 900 is pressed and drug delivery is dispensed, this binary value changes state to indicate that priming is in progress.

[0111] As an example for a particular technology, it may be determined whether a user is dispensing drug administration for the Symbicort inhaler 10 in FIG. 1A. The actuation detection IR sensor 338 determines the state of the cannister 14 of the inhaler 10 and determines whether it is being pressed. This data is presented as binary values in the live data and raw readings of the IR sensor 338. When the user presses the cannister 14 for drug administration dispensing, this value changes. By pairing this data with the inhalation data collected from the pressure sensor 326 and the timing of each reading, it becomes possible to determine whether the user is priming the inhaler 10 without inhalation or inhaling without drug administration dispensing, whether the inhalation is too weak, or whether the timing of inhalation and drug administration dispensing is appropriate to receive one full dose.

[0112] FIG. 17 is a block diagram of an exemplary healthcare system 1700 for obtaining compliance data and other data from a compliance monitor (e.g., compliance monitor 100) of a patient using an inhaler (e.g., inhaler 10 in FIG. 1A, inhaler 900 in FIG. 9A, or inhaler 1300 in FIG. 13A). The healthcare system 1700 includes a plurality of inhalers (e.g., inhaler 10 in FIG. 1A, inhaler 900 in FIG. 9A, or inhaler 1300 in FIG. 13A or any other type of inhaler that may be operable to provide a corresponding user or patient 1710a, 1710b, and 1710c with a drug dosage). The healthcare system 1700 includes a data server 1712, an electronic medical record (EMR) server 1714, a health or home care provider (HCP) server 1716, and corresponding patient computing devices 1720a, 1720b, and 1720c. In this example, patient computing device 1720a is in the vicinity of inhaler 10 and attached compliance monitor 100. Similarly, patient computing devices 1720b and 1720c are in the vicinity of inhalers 900 and 1300 and attached compliance monitors 950 and 1350. In system 1700, all of these entities are configured to be connected to a wide area network 1730 (e.g., the Internet) and communicate with each other via the wide area network 1730. The connection to the wide area network 930 may be wired or wireless. The EMR server 1714, the HCP server 1716, and the data server 1712 may all be executed on separate computing devices in separate locations, or any partial combination of two or more of these entities may be executed together on the same computing device.

[0113] Patient computing devices 1720a, 1720b, and 1720c can be personal computers, mobile phones, tablet computers, or other devices. Patient computing device 1720a is configured to mediate between patient 1710a and a remote entity of system 1700 via wide area network 1730. In an embodiment of FIG. 17, this mediation is accomplished by software application program 940 executing on patient computing device 1720. Patient program 1740 operated by patient computing devices 1720a, 1720b, and 1720c may be a dedicated application referred to as a "patient app," or may be a web browser that interacts with a website provided by a healthcare provider or in-home healthcare provider. System 1700 may include other inhalers and compliance monitors (not shown) associated with each patient, and these inhalers (not shown) are associated with each patient having their respective associated computing device and an associated HCP server (possibly shared with other patients). All patient / inhaler users within system 1700 may be managed by data server 1712.

[0114] As described above, compliance data from monitors 100, 950, and 1350 can be correlated with the addition of drug dosages from inhalers 10, 900, and 1300. Further data from monitors 100, 950, and 1300 can be collected by patient computing devices 1720a, 1720b, and 1720c for tracking a patient's drug application technique as described above in relation to analysis module 1754. Such data can be transmitted by patient computing devices 1720a, 1720b, and 1720c to data server 1712. Analysis module 1754 can provide an analysis of the data collected from the routine in FIG. 8 (determining the appropriate technique of the inhaler by an individual patient during use).

[0115] In this example, monitors 100, 950, and 1350 are configured to transmit data collected from inhaler actuations from the addition of drug dosages to each patient computing device 1720a, 1720b, and 1720c via a wireless protocol. This wireless protocol receives the above data as part of patient program 1740. Then patient computing devices 1720a, 1720b, and 1720c transmit the data to data server 1712 according to a pull or push model. Data server 1712 may receive data from computing devices 1720a, 1720b, and 1720c according to a "pull" model, whereby computing devices 1720a, 1720b, and 1720c transmit physiological data in response to a query from data server 1712. Alternatively, data server 1712 may receive physiological data according to a "push" model, whereby computing devices 1720a, 1720b, and 1720c transmit event data to data server 1712 as soon as physiological data becomes available after a dosage has been administered from the inhaler. Further, data server 1712 may access database 1760 to store the collected and analyzed data related to patients 1710a, 1710b, and 1710c and the big data related to the overall population of patients.

[0116] Data received from patient computing devices 1720a, 1720b, and 1720c is stored and indexed by data server 1712 so as to be distinguishable from data collected from any other monitor in system 1700 by being uniquely associated with monitors 100, 950, and 1350. In this regard, for ease of explanation, only three inhalers and monitors are illustrated in FIG. 17, but system 1700 can include a greater number of inhalers and monitors. Data server 1712 can be configured to calculate summary data for each dosage amount from data received from monitor 100. Data server 1712 can also be configured to receive data from patient computing devices 1720a, 1720b, and 1720c (e.g., data entered by each patient 1720a, 1720b, and 1720c, behavioral data about the patient, or dosage / summary data).

[0117] EMR server 1714 includes electronic medical records (EMRs) (i.e., both electronic medical records (EMRs) specific to patients 1710a - c and comprehensive electronic medical records (EMRs) for a larger population of patients having diseases similar to patients 1710a - c). EMRs, also referred to as electronic health records (EHRs), typically include a patient's medical history (e.g., previous condition, treatment, complications, and current condition). EMR server 1714 can be located, for example at the hospital where any of patients 1710a - c last received treatment. EMR server 17914 is configured to send EMR data to data server 1712, perhaps in response to receiving a query from data server 1712.

[0118] In this example, the HCP server 1716 is associated with a health / homecare provider (which can be an individual healthcare professional or an organization) responsible for a patient's respiratory therapy. The HCP can also be referred to as a DME or HME (domestic / home medical equipment provider). The HCP server 1716 can host process 1752, which will be described in more detail below. As one function of the HCP server process 1752, in response to receiving a query from the data server 1712, it may send data related to patients 1710a - c to the data server 1712.

[0119] In some implementations, the data server 1712 is configured to communicate with the HCP server 1716 to trigger notifications or action recommendations to an HCP surrogate (e.g., a nurse) or to support various reports. Details of the actions performed are stored by the data server 1712 as part of the engagement data. The HCP server 1716 hosts an HCP server process 1752 that communicates with an analysis module 1754 and a patient program 940.

[0120] For example, the HCP server process 1752 can obtain a compliance analysis on whether an inhaler is being operated correctly. Also, the HCP server process 1752 can include the ability to monitor a patient's inhaler use according to compliance rules. These compliance rules specify the required inhaler usage over a compliance period (e.g., 30 days) for a certain minimum number of days (e.g., 21 days) within the compliance period for the minimum number of administrations. In post - processing the summary data, by comparing the usage time with the minimum duration from the compliance rules, it can be determined whether the most recent duration is a compliant session. The results of such post - processing are referred to as "compliance data". Such compliance data can be used when a healthcare provider individually adjusts a treatment that may include an inhaler and other mechanisms. Other stakeholders (e.g., payers) can use the compliance data to determine whether there can be reimbursement for the patient.

[0121] As will be appreciated, the data in data server 1712, EMR server 1714, and HCP server 1716 is often confidential data related to patients 1710a - c. Typically, it is often necessary to obtain permission from patients 1710a - c to send confidential data to another party. Such permission may be required for data transfer between servers 1712, 1714, and 1716 (however, if such servers are operated by different entities).

[0122] The terms "component", "module", "system", etc. as used in this application generally refer to computer - related entities, which can be either hardware (e.g., circuitry), a combination of hardware and software, software, or an entity related to an operating machine having one or more specific functions. For example, a component can be, but is not limited to, a process executed on a processor (e.g., a digital signal processor), a processor, an object, an executable file, an execution thread, a program, and / or a computer. As an example, both a controller and an application operating on the controller can be components. One or more components can exist within a process and / or an execution thread, and a component can be localized on one computer or distributed between two or more computers. Further, a "device" can take the form of specially designed hardware, off - the - shelf hardware specialized by the execution of software enabling the performance of specific functions, software stored on a computer - readable medium, or a combination thereof and can be in various forms.

[0123] The terms used in this specification are for the sole purpose of describing particular embodiments and are not intended to be limiting of the present invention. The singular forms "a", "an", and "the" as used herein are intended to include the plural forms as well, unless the context clearly dictates otherwise. Further, in the description of embodiments for carrying out the invention and in the claims, the terms "comprising", "having", or their inflected forms are used, and these terms are intended to be inclusive in the same manner as the term "including".

[0124] Unless otherwise defined, all terms (including technical and scientific terms) used in this specification have the same meaning as commonly understood by one of ordinary skill in the art. Furthermore, terms defined as in a widely used dictionary should be interpreted to be consistent with the meaning in the context of the relevant art and should not be interpreted in an idealized or overly formal sense unless explicitly so defined in this specification.

[0125] As described above, various embodiments of the present invention have been described, but they are presented for illustrative purposes only and should not be construed as limiting. Although the present invention has been illustrated and described with respect to one or more implementations, equivalent changes and modifications may occur upon reading and understanding this specification and the accompanying drawings, or may be known to other persons skilled in the art. In addition, certain features of the present invention may be disclosed with respect to only one of several implementations, but such features may be combined with one or more other features of other implementations so as to be desirable and advantageous for any given or particular application. Accordingly, the breadth and scope of the present invention should not be limited by any of the above-described embodiments. Rather, the scope of the present invention should be defined in accordance with the following claims and their equivalents.

[0126] The following describes the appended claims of the present disclosure. (Appended Claim 1) A compliance monitor attachable to an inhaler, the inhaler having a drug cannister covered by a cannister cover, an actuator for holding the drug cannister, the actuator having a mouthpiece, and a dosing device operable to actuate the drug cannister to dispense a single dose, the compliance monitor comprising: an actuation detection sensor operable to sense physical movement of the drug cannister during actuation; an inhalation data sensor operable to sense from the actuation a change in air pressure resulting from inhalation of the single dose; a controller coupled to the actuation detection sensor and the inhalation data sensor to record actuation events. (Appended Claim 2) The compliance monitor of appended claim 1, further comprising an accelerometer coupled to the controller, the accelerometer outputting a signal indicative of movement of the inhaler prior to actuation, the controller being operable to activate the sensors when such movement is detected. (Appended Claim 3) The compliance monitor according to any one of appended claims 1 to 2, wherein the actuation detection sensor is an infrared sensor. (Appended Claim 4) The compliance monitor according to any one of appended claims 1 to 3, wherein the actuation detection sensor is a contact switch. (Appended Claim 5) The compliance monitor according to any one of appended claims 1 to 4, wherein the actuation detection sensor is an atmospheric pressure sensor. monitor. (Appended Claim 6) The compliance monitor according to any one of appended claims 1 to 5, wherein the inhaler includes a shield attached to the cannister cover, and the actuation detection sensor detects movement of the shield as indicative of movement of the inhaler. (Appended Claim 7) The inhalation data sensor is a pressure sensor, and the controller is operable to determine a pressure curve during inhalation of the single dose from the inhaler, the compliance monitor according to any one of claims 1 to 6. (Claim 8) The controller is operable to add a time stamp indicating the movement of the inhaler to the collected data, the compliance monitor according to any one of claims 1 to 7. (Claim 9) The compliance monitor further includes a transceiver connected to the controller, and the controller is operable to transmit data based on the actuation event to an external client device that communicates with the transceiver, the compliance monitor according to any one of claims 1 to 8. (Claim 10) The external client device is a mobile computing device associated with the user, and the external client device executes an application that analyzes the collected data to determine the compliance, the compliance monitor according to claim 9. (Claim 11) The compliance monitor further includes an attachment detection sensor operable to detect when the inhaler is attached to the compliance monitor, the compliance monitor according to any one of claims 1 to 10. (Claim 12) The compliance monitor further includes an actuation button that can be operated by the user to activate the controller and the sensor, the compliance monitor according to any one of claims 1 to 11. (Claim 13) The compliance monitor further includes a body that fits and attaches onto the cannister cover of the inhaler, the compliance monitor according to any one of claims 1 to 12. (Claim 14) The inhalation data sensor is disposed on a circuit board so as to be exposed in a gap between the compliance monitor and the cannister cover of the inhaler, the compliance monitor according to any one of claims 1 to 13. (Claim 15) A compliance monitor attachable to an inhaler, the inhaler comprising a drug canister and an actuator for holding the drug canister, the actuator having a cylindrical body with the drug canister held at one end together with a mouthpiece on the other end, an actuator, and a dosing device attached to the drug canister, the dosing device including a front shield surface and being operable to actuate the drug canister to release a single dose, the compliance monitor comprising a pair of curved side walls that coincide with the sides of the cylindrical body of the actuator, each side wall having an open front edge and a closed trailing edge; a side arm attached to one of the side walls so as to overlap the cylindrical body of the actuator, the mouthpiece of the inhaler being accessible and the front shield surface being exposed, the side arm, an electronic device housing attached to the closed trailing edge of the side wall, and a compliance monitor including (Additional item 16) The inhaler includes a lower strap, and each side wall includes a lower portion forming a slot for the strap, the compliance monitor of additional item 15. (Additional item 17) An actuation detection sensor operable to sense physical movement of the drug canister during actuation, An inhalation data detection sensor operable to sense an air pressure change generated due to the actuation, A controller in the electronic device housing connected to the sensors to record actuation events, and a compliance monitor according to any one of additional items 15 to 16 including (Additional item 18) Further include a printed circuit board in the electronic device housing, the printed circuit board has a first surface including a connector connected to the operation detection sensor, and the operation detection sensor is one of the side walls in the vicinity of the shield surface of the inhaler and the second opposite surface where the inhalation data sensor is attached in the vicinity of the gap between the upper cover of the side wall and the actuator of the inhaler. The compliance monitor according to claim 17, which is attached on one of them. (Claim 19) The compliance monitor according to claim 18, further including an attachment detection sensor attached on the first surface of the printed circuit board, which is operable to detect the attachment to the compliance monitor of the inhaler. (Claim 20) The compliance monitor according to claim 18, wherein the electronic device housing includes a back panel having an operation button operable to activate a controller and a sensor. (Claim 21) A compliance monitor attached to an inhaler, the inhaler includes a drug canister and an actuator for holding the drug canister, the actuator has one end for holding the drug canister together with a mouthpiece on the other end and a canister cover covering the drug canister, the drug canister is operable to be actuated to release a single dose, and the monitor A main body fitted and attached around the canister cover, An electronic device housing attached to the main body, An operation detection sensor operable to sense the drug canister during operation, An inhalation data detection sensor operable to sense an air pressure change generated due to the operation, A controller in the electronic device housing connected to the sensor to record an operation event, and a compliance monitor including the same. (Claim 22) Further include a printed circuit board in the electronic device housing, the printed circuit board having a first surface with an operation detection sensor and a second opposing surface to which the inhalation data sensor is attached adjacent to a gap between the upper cover of the electronic device housing and the cannister cover of the inhaler, the compliance monitor of claim 21. (Claim 23) The electronic device housing includes a panel having an operation button operable to activate a controller and a sensor, the compliance monitor according to claim 22. (Claim 24) The cannister cover is physically movable to operate a drug cannister, the compliance monitor according to any one of claims 21 to 23. (Claim 25) The operation detection sensor is a limit switch that activates when the cannister cover is moved, the compliance monitor according to claim 24. (Claim 26) The operation detection sensor and the inhalation detection sensor are atmospheric pressure sensors, claims 21 to 25 the compliance sensor according to any one of.

Claims

1. A compliance monitor attachable to an inhaler, the inhaler comprising a drug cannister and an actuator for holding the drug cannister, the actuator having one end for holding the drug cannister together with a mouthpiece on the other end and a cannister cover for covering the drug cannister, the drug cannister being operable to be actuated to release a single dose, the compliance monitor comprising: a body fitted and attached around the cannister cover; an electronic device housing attached to the body; an actuation detection sensor operable to sense the drug cannister during actuation; an inhalation data detection sensor operable to sense an air pressure change generated due to the actuation; a controller in the electronic device housing connected to the actuation detection sensor and the inhalation data detection sensor for recording an actuation event. A compliance monitor comprising the above components.

2. The compliance monitor according to claim 1, further comprising a printed circuit board within the electronic device housing, the printed circuit board having a first surface with an actuation detection sensor and a second opposing surface with the inhalation data detection sensor attached adjacent to a gap between an upper cover of the electronic device housing and the cannister cover of the inhaler.

3. The compliance monitor according to claim 2, wherein the electronic device housing includes a panel having an actuation button operable to activate the controller, the actuation detection sensor, and the inhalation data detection sensor.

4. The compliance monitor according to any one of claims 1 to 3, wherein the cannister cover is physically movable to actuate the drug cannister.

5. The compliance monitor according to claim 4, wherein the actuation detection sensor is a limit switch that activates when the cannister cover is moved.

6. The compliance monitor according to any one of claims 1 to 5, wherein the actuation detection sensor and the inhalation detection sensor are atmospheric pressure sensors.

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