US20150174348A1 - Compliance monitoring for inhalers - Google Patents

Abstract

Devices and methods are disclosed for monitoring a patient's compliance with an inhaler treatment regimen. The device may monitor an inhaler's motion to determine whether the motion is characteristic of typical inhaler use. Additionally, the device may monitor a temperature of the inhaler or in proximity to the mouthpiece to determine whether a patient has used the inhaler. The devices and methods may incorporate a smart phone application that provides notifications and alerts to aid in compliance with the medication regimen.

Description

PRIORITY AND INCORPORATION
• Any and all applications for which a foreign or domestic priority claim is identified in the Application Data Sheet as filed with the present application are hereby incorporated by reference under 37 CFR 1.57. In particular, the present application is a continuation of U.S. patent application Ser. No. 14/054,638, filed Oct. 15, 2013, titled “COMPLIANCE MONITORING FOR ASTHMA INHALERS,” which claims the benefit under 35 U.S.C. §119(e) of both U.S. Provisional Patent Application No. 61/836,580, filed Jun. 18, 2013, and also of U.S. Provisional Patent Application No. 61/883,155, filed Sep. 26, 2013, both titled “COMPLIANCE MONITORING FOR ASTHMA INHALERS.” The entire disclosure of each of the above items (including each appendix of the second listed provisional application) is hereby made part of this specification as if set forth fully herein and incorporated by reference for all purposes, for all that each contains.
BACKGROUND
• Asthma is a chronic respiratory condition that causes a patient's airways to narrow, making it difficult to breath. Additionally, asthma may cause wheezing, chest tightening, shortness of breath and coughing. Asthma is generally caused by an oversensitivity to inhaled substances that causes the smooth muscle lining in the bronchial airways to constrict and tighten. The airways may also swell and secrete mucous, further constricting airflow. During Asthma attacks, a patient's airways may narrow to the point where the condition may be life threatening. Some treatments for Asthma are administered periodically through the mouth of a patient. Various devices can be used to administer these treatments.
SUMMARY
• Improving compliance with treatment regimes that call for periodic administration may have a multitude of benefits including reduced health care costs, reduced health insurance premiums for patients, and improved patient quality of life. Examples of such regimes include those involving inhalers of various types that introduce therapeutic agents into the respiratory system. Thus, to take Asthma treatments as an example, a need exists for systems and methods to increase the compliance of patient's periodic (e.g., daily) preventive asthma treatments to reduce costs for preventable hospitalizations due to asthma attacks. Additionally, a need exists for systems and methods that are appropriately adaptable to several types of inhalers. However, the variety of inhaler types and operation makes it difficult to develop a standardized monitor for monitoring compliance. Aspects of the present disclosure address some of these needs.
• Example embodiments described herein have several features, no single one of which is indispensable or solely responsible for their desirable attributes. Without limiting the scope of the claims, some of the advantageous features will now be summarized.
• For example, a system for assisting a patient in compliance with an asthma medication dosage regimen can be provided. The system can comprise: a housing configured to be removably connectable to an asthma inhaler configured to enclose asthma medication; a memory in communication with the controller; a battery in electrical communication with the controller and the memory; an alert indicator; a communication interface for sending and receiving data that is in electrical communication with the controller and the memory; a motion sensor in electrical communication with the controller that detects at least a position and a motion of the housing with respect to gravity, the motion sensor physically coupled to the asthma inhaler such that it can detect signature motions of the inhaler and the enclosed asthma medication, the signature motions indicative of preparation by a user for administration of a dose of the asthma medication; and a temperature sensor in electrical communication with the controller, the temperature sensor configured to detect confirming temperatures on or near the asthma inhaler within a time window of any signature motions, the confirming temperatures indicative that the user followed the proper procedure for administering a dose of the asthma medication. The system can further comprise a controller configured to: process data output from the motion sensor to determine signature motions; process data output from the temperature sensor to determine confirming temperatures; and evaluate the timing of any signature motions and confirming temperatures to determine whether a use of an asthma inhaler by a patient has occurred to deliver a dose of the asthma medication.
• Moreover, a system such as the one summarized above can assist a patient in compliance with an asthma medication dosage regimen by processing data output from the motion sensor, which can include one or more of the following: analyzing frequency of the data (e.g., by implementing a band-pass filter that passes frequencies at least in the range of 3-7 Hz., for example); and/or processing of acceleration data (which can include, e.g., determining whether the acceleration data reaches a certain threshold magnitude). One example of the signature motion discussed above can be a shaking motion. The temperature sensor mentioned in the above paragraph can be, for example, an infra-red temperature sensor positioned on the housing and/or otherwise configured to detect proximity and/or temperature of a patient's oral cavity that may indicate actual use of an asthma inhaler. The temperature sensor mentioned above can be, for example, positioned and/or configured to sense a temperature of a pressurized cartridge of an inhaler.
• A monitor for detecting usage of an asthma inhaler can be provided. The monitor can comprise: a housing; a controller; a wireless communication interface in electronic communication with the controller and connected to the housing; and a memory and a battery in electrical communication with the controller and contained within the housing. The monitor can further comprise a motion sensor in electrical communication with the controller that outputs data indicative of an acceleration of the housing, and the motion sensor can be physically coupled to the asthma inhaler such that it can detect signature motions of the inhaler and the enclosed asthma medication. The signature motions can indicate preparation by a user for administration of a dose of the asthma medication. The monitor can further comprise a temperature sensor in electrical communication with the controller, and the temperature sensor can be configured to detect temperatures on or near the asthma inhaler within a time window of any signature motions, the temperatures indicative that the user inhaled the medication. The monitor can further comprise a controller configured to: process data output from the motion sensor to identify signature motions; process data output from the temperature sensor to identify confirming temperatures; and evaluate the timing of any signature motions and confirming temperatures to determine whether a use of an asthma inhaler has occurred.
• Moreover, the monitor described in the previous paragraph can evaluate the timing of any signature motions and confirming temperatures by doing one or more of the following: determining whether the temperature data indicative of use occurred later in time than the motion data indicative of use; identifying a decrease in temperature of a pressurized cartridge of the asthma inhaler; identifying a temperature increase in proximity to a mouthpiece connected to the housing of the inhaler; and/or identifying a temperature increases by an amount indicative of a patient's mouth being in proximity to a mouthpiece connected to an inhaler housing. The controller of the monitor described above can be configured to process data output from the motion sensor to identify signature motions that result from a lever being actuated on a DPI inhaler.
• A method of processing data output from a series of sensors connected to an asthma inhaler can be provided, thereby determining whether the asthma inhaler has been used. The method can include one or more of the following steps: detecting data relating to signature motions of the sensors, the signature motions indicative of preparation by a user for administration of a dose of the asthma medication; detecting a temperature on or near the asthma inhaler within a time window of any signature motions, the temperatures indicative that the user inhaled the medication; processing the signature motion data to determine whether it is indicative of use of an asthma inhaler; processing the temperature data to determine whether it is indicative of use of an asthma inhaler; and evaluating the timing of the signature motion data relative to the temperature data to determining whether an asthma inhaler has been used.
• Moreover, a method such as that described in the previous paragraph can further include associating a date, time, and location with a use after the evaluating step has confirmed that a use of an asthma inhaler has occurred. In the method(s) described above, detecting data relating to the motion of the sensors can further include detecting an acceleration. In the method(s) described above, processing the temperature data can include determining whether a temperature of an inhaler cartridge has decreased. In the method(s) described above, processing the motion data can include determining whether a frequency of the acceleration reaches a threshold magnitude.
BRIEF DESCRIPTION OF THE DRAWINGS
• The following drawings and the associated descriptions are provided to illustrate embodiments of the present disclosure and do not limit the scope of the claims. Aspects and many of the attendant advantages of this disclosure will become more readily appreciated as the same become better understood by reference to the following detailed description, when taken in conjunction with the accompanying drawings, wherein:
• FIG. 1 is an overview of an asthma compliance monitoring system.
• FIG. 2A is a perspective view of a metered dose inhaler (MDI).
• FIG. 2B is a perspective view of a dry powdered inhaler (DPI).
• FIG. 2C is a perspective view of a nebulizer inhalation system.
• FIG. 2D is a perspective view of piezoelectric nebulizer inhaler.
• FIG. 2E is a perspective view of an example nebulizer inhaler system that uses an internal piston compressor.
• FIG. 3A is a perspective view of a monitor housing configured as a cap and attached to a metered dose inhaler.
• FIG. 3B is a perspective view of a monitor housing configured as a ring and attached to a metered dose inhaler.
• FIG. 3C is a perspective view of a monitor housing connected to a metered dose inhaler
• FIG. 3D is a perspective view of a monitor housing connected near the mouthpiece of a metered dose inhaler.
• FIG. 3E is a side view of a monitor in the shape of a clip.
• FIG. 3F is a perspective view of a monitor in the shape of a clip.
• FIG. 3G illustrates a monitor in the shape of a clip attached to a metered dose inhaler.
• FIG. 4A is a perspective view of a monitor housing connected to a top portion of a dry powdered inhaler.
• FIG. 4B is a perspective view of a monitor housing connected to a side portion of a dry powdered inhaler.
• FIG. 4C is a perspective view of a monitor in the form of a clip for a DPI inhaler.
• FIG. 4D is a perspective view of a monitor in the form of a clip for a DPI inhaler that has been attached to an inhaler.
• FIG. 4E is a side view of a monitor in the form of a clip for a DPI inhaler that has been attached to an inhaler.
• FIG. 4F is a perspective view of a monitor in the form of a cover for a DPI inhaler.
• FIG. 4G is a perspective view of a monitor in the form of a cover for a DPI inhaler that has been attached to an inhaler.
• FIG. 4H is a plan view of a monitor in the form of a cover for a DPI inhaler that has been attached to an inhaler, with angles indicated schematically.
• FIG. 4I is a section view of two portions of a cover for a DPI inhaler.
• FIG. 4J is a perspective view of a low-profile sensor mounted on the back of a DPI inhaler.
• FIG. 5 is a perspective view of a monitor housing connected near a mouthpiece of a nebulizer.
• FIG. 6 is a perspective view of a monitor housing connected near a mouthpiece of a piezoelectric nebulizer.
• FIG. 7 is an overview of the components of a monitor.
• FIG. 8 is an overview of the components of a system including a monitor integrated with an application installed on a mobile device.
• FIG. 9 illustrates an example system architecture diagram for sensors.
• FIG. 10 illustrates an example of how a modular device may be able to interface with different types of inhalers and may be able to distinguish between them.
• FIG. 11 illustrates a combined system overview with device hardware, software and a web portal.
• FIG. 12 is a sequence of steps for monitoring usage of an inhaler.
• FIG. 13 is a flow chart representing the processing of inhaler usage data.
• FIG. 14 is an overview of the inhaler compliance system.
• FIG. 15 is an overview of the refill monitoring and ordering system.
• FIG. 16 is a flow chart representing the sequence of steps for ordering a refill.
• FIG. 17 illustrates an overview of a system utilizing a neural network.
• FIG. 18 illustrates a perspective view of a MDI inhaler and a universal monitor.
• FIG. 19 illustrates a perspective view of a DPI inhaler and a universal monitor.
• FIG. 20 illustrates schematically how one or more sensors can confirm that one or more criteria have been completed.
• FIG. 21A shows accelerometer data taken when an accelerometer is shaken in the way that an inhaler would be shaken before use.
• FIG. 21B shows data from a longer period of time that includes the time depicted inFIG. 21A.
• FIG. 21C shows data gathered during a short sprint of only a few steps, with the accelerometer being held in a pocket.
• FIG. 21D shows data gathered during a short sprint of only a few steps, with the accelerometer being held in a hand.
• FIG. 21E shows acceleration data for walking while holding the accelerometer in a pocket.
• FIG. 21F shows data for tossing the accelerometer into the air and catching it repeatedly.
• FIGS. 22A and 22B include data from picking up a DPI and moving it laterally toward the mouth of a user.
• FIG. 22C shows data from a user bringing the device up to their mouth and moving it away multiple times.
• FIG. 22D shows data recorded while picking up an inhaler, moving it toward the mouth, breathing, moving it away and then putting it down.
• FIG. 23 shows data from a gyroscope sensor to validate use in accordance with a rotating embodiment such as those ofFIG. 4F-FIG.4I.
• FIGS. 24A-24B show temperature data from ambient air and a human cheek.
• FIGS. 24C-24D show temperature data from four human exhale-inhale events.
• FIG. 24E-24F show temperature data using a clear plastic cover.
• FIG. 24G-24H show data taken with another plastic covering.
• FIG. 24I-24J show data from further testing.
DETAILED DESCRIPTION
• Although certain preferred embodiments and examples are disclosed below, inventive subject matter extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses and to modifications and equivalents thereof. Thus, the scope of the claims appended hereto is not limited by any of the particular embodiments described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable sequence and are not necessarily limited to any particular disclosed sequence. Various operations may be described as multiple discrete operations in turn, in a manner that may be helpful in understanding certain embodiments; however, the order of description should not be construed to imply that these operations are order dependent. Additionally, the structures, systems, and/or devices described herein may be embodied as integrated components or as separate components. For purposes of comparing various embodiments, certain aspects and advantages of these embodiments are described. Not necessarily all such aspects or advantages are achieved by any particular embodiment. Thus, for example, various embodiments may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages as may also be taught or suggested herein.
• This disclosure relates to systems and methods that help monitor movement and temperature, for example. Sensors (including movement and temperature s) can be used to assist in compliance with medical instructions. To take one example, periodic dosing can be improved by sensors that track movements and temperatures associated with administration of therapeutic agents. Medications that call for use of an inhaler can be particularly well suited for a system that assists in tracking periodic administration, because they are often administered after a vigorous shaking motion is used to mix the therapeutic ingredients. This motion can be detected with motion sensors. Moreover, they are often administered using an inhaler that is placed in close proximity to or within an oral cavity. Because this is a warm environment, temperature sensors can be advantageously used to track when doses are administered. The change in pressure involved as some pressurized inhaler containers are discharged can also lead to temperature changes that can be tracked or sensed with temperature sensors. Several other physical characteristics of such dosing systems and their interactions with human subjects are discussed further herein. Because asthma treatments are commonly provided through inhalers and often call for regular periodic dosing, this disclosure refers to asthma. However, these examples are not limiting but merely serve to provide context and one example use for the technology described herein.
• For example, other treatment regimes that require certain motions and interaction with the human body may allow for implementation of similar devices and methods. Diabetes requires periodic administration of dosages of insulin, and/or periodic measuring of blood glucose. The various motions associated with preparing the insulin dosage or blood testing kit may be analyzed along with the temperature changes that accompanying bringing an injection devices or blood tester in close proximity to the body. Accordingly, these devices may apply to a wide range of systems and methods and inhaler may be replaced with needles, syringes, testers, and other devices that may come into proximity with the human body.
• The precise mechanism and triggers that cause asthma are unknown and widely variable among patients. Certain environmental, temporal and genetic factors may increase or change a patient's susceptibility to an attack at a given time. For example, certain patients may be sensitive to different types of inhaled irritants, or may be more susceptible during exercise. Therefore, predicting asthmatic reactions in patients is difficult, and patients generally rely on unscientific experience to determine their specific triggers.
• In the United States alone, over 25 million people suffer from asthma, 7 million of which are children. Asthma has no cure, but may be managed with inhaled medications. Some patients may even eliminate most symptoms of asthma with regular usage of medication. Generally, asthma medications may be broken down into two categories: daily preventive treatments and rescue medications. Rescue medications are generally bronchodilators that quickly relax the smooth muscle in the bronchioles in order to dilate the airways and improve ease of breathing during an asthma attack.
• Daily preventive treatments typically include anti-inflammatory drugs that reduce the swelling and mucous production in the airways and accordingly reduce a patient's susceptibility to triggers. Preventative anti-inflammatories are effective at controlling and even preventing asthma symptoms.
• However, preventive treatments are only effective if they are taken consistently at the prescribed times. According to a study by the Johns Hopkins and Allergy center, compliance rates are commonly reported to be in the range of 30%-70% among children and adult patients. Generally, asthma compliance is difficult to maintain because the medications may be required three times daily, and remission of symptoms due to non-compliance does not occur for several days. Thus, the delayed feedback in remission removes critical reinforcement to the importance of taking the medication consistently. Also, many patients may have as many as three different types of medication, making the different inhalers difficult to account for. Accordingly, Asthma treatment compliance is difficult to maintain among asthma patients, especially in the case of adolescents and children. This causes many preventable attacks and hospitalizations to occur, wasting millions of healthcare dollars year after year. Additionally, insurance premiums for asthma patients remain potentially higher than if they achieved improved compliance.
• Asthma medications are primarily administered through three different types of inhalers: metered dose inhalers (MDI), dry powdered inhalers (DPI), and nebulizers. MDI inhalers include pressurized cartridges that a patient actuates by pressing down and breathing in while the medication is sprayed out of a nozzle. During dispensing, the pressure of the contents decreases as it enters the atmosphere. Due to Gay-Lussac's law (P₁/T₁=P₂/T₂), the temperature of the canister also drops when the pressure decreases, causing a noticeable drop in temperature of the cartridge for each actuation of the MDI relative to the atmosphere.
• DPI inhalers come in several forms including the common disc shaped inhaler. The disc shaped inhaler contains several single dose capsules of medication. These single doses are contained in packets evenly spaced along a strip that is coiled around an internal gear. To dispense the medication, the patient first slides an actuator to uncover the next dose on the strip while winding it into position near the mouthpiece. Next, the patient brings the inhaler to their mouth, and inhales deeply. The airflow created by the patient inhalation forces the powder to exit the nozzle and enter the lungs.
• Nebulizers deliver medication to a patient by vaporizing liquid drugs using either pressurized air, ultrasonic vibration, or other modes e. For example, pressured air may be used to push the liquid through a nozzle. In the case of the ultrasonic nebulizer, a piezoelectric transducer may be used to produce vibrations that create a fine mist on the surface of the liquid. Additionally, a mesh ultrasonic nebulizer vibrates a mesh screen on the surface of a liquid creating a mist that is inhaled. Accordingly, many different inhaler types for delivering asthma medication exist, each with different methods of storing and delivering medication.
• The present disclosure relates to systems, methods, and kits for assisting asthma inhaler compliance and prevention. Embodiments will now be described with reference to the accompanying figures, wherein like numerals refer to like elements throughout. The terminology used in the description presented herein is not intended to be interpreted in any limited or restrictive manner, simply because it is being utilized in conjunction with a detailed description of embodiments. Furthermore, embodiments may include several novel features, no single one of which is solely responsible for its desirable attributes or which is essential to practicing the technology herein described.
• Some systems for compliance monitoring can utilize mechanically actuated switches in order to confirm an inhaler has been used. In these devices, the device is integrated with the moving parts of the inhaler in order to actuate the compliance monitor with the same patient force applied to actuate the inhaler. Thus, these systems are often customized and built to conform to the physical characteristics of each inhaler type. Therefore, these systems can be physically complicated and expensive to manufacture. Furthermore, these systems include moving parts and associated openings that can be prone to contamination and wear and tear.
• Accordingly, systems, methods, and kits have been developed for monitoring the compliance of an inhaler that are adaptable to a variety inhaler types. These systems and kits can use some non-mechanical methods of verifying or detecting inhaler use. In some embodiments, these non-mechanical methods include monitoring and verifying at least two different characteristics of the inhaler that are indicative of usage.
• Some systems and kits utilize motion sensing and temperature sensing capabilities to determine whether the device has been actuated. This advantageously provides confirmation of usage at two different stages of inhaler actuation, which may eliminate a significant number of false positives. For example, if an inhaler is shaken in preparation for administering medication, but not ultimately actuated, the temperature sensor does not detect a change indicative of usage and thus the monitor does not record a use. Accordingly, if the inhaler only detected the motion, a false positive may have been recorded. Similarly, if the canister is actuated and the temperature decreases but the monitor did not detect the prescribed shaking of the inhaler, the monitor determines that the patient inhaled the medication without properly shaking it in advance.
• In an example of a method for confirmation of usage, in the first stage a monitor may first detect motions that are characteristic of inhaler use depending on the type of inhaler. For example, for an MDI inhaler, the monitor may detect the shaking motion prescribed prior to dispensing the medication. For a DPI inhaler, the monitor may detect the actuation of the slider that breaks the medication powder capsule. For a nebulizer inhaler, the algorithm may detect the vibration associated with the nebulizer's piezoelectric transducer vibration. All of these motions may be indicative that the user is preparing to use the inhaler.
• Next, in a second stage of usage confirmation, the monitor may detect temperature changes to validate use. For example, for an MDI inhaler, the monitor may detect a temperature of the cartridge to determine whether the pressure dropped relative to the atmosphere to confirm actuation. In another example method, the monitor may detect temperature changes in or near a mouthpiece of an inhaler to detect the user's mouth. This provides additional confirmation that the user actually brought the inhaler close to their mouth to inhale the medication. Accordingly, this may eliminate a significant number of false positives as a patient is unlikely to bring an inhaler close to their mouth without using the inhaler.
• These are only examples of the monitors, kits, and methods for detecting inhaler usage. Many variations of these methods may be utilized to confirm inhaler usage. These and other examples will be explained further, as potential systems and methods for implementing an asthma compliance management system.
Asthma Compliance Monitor System Overview
• FIG. 1 illustrates an overview of an example asthmacompliance monitor system280. Anasthma compliance system280 may include aninhaler100, an associatedmonitor200, and amobile device150. “Monitor” is a broad term that can be used as a noun and is entitled to its customary and ordinary meaning. That meaning can include, without limitation, a system for monitoring (e.g., tracking, assessing, reporting, recording, analyzing, reminding, and/or notifying regarding) asthma compliance. The monitor or a monitor system can include various components enclosed within a single or multiple housings in electrical communication with components either aggregated on a single chip or spread across different devices at potentially different locations, and may include various sensors, including temperature sensors, motion detectors, infra-red sensors, inductance sensors, accelerometers, gyroscopes, circuit boards, transmitters, wireless transmitters, and other components and connectivity. For example, a monitor can be a package that includes both motion-sensing and temperature-sensing portions, which can be piezo-electric. A monitor can also be a kit or collection of devices that collectively perform a compliance assessment function. For example, a monitor can include a mobile device with a processor that runs an application to coordinate or communicate the monitoring activities of the monitor. The term “monitor” can also be a verb and is used herein in its ordinary sense, which can include, without limitation, tracking, assessing, reporting, recording, analyzing, reminding, and/or notifying functions.
• As a patient uses aninhaler100 in electronic communication with thesystem280, each use (or each movement or temperature potentially associated with a use) can be detected by themonitor200, and transmitted to amobile device150. Mobile device is a broad term, and is entitled to its customer and ordinary meaning and it includes, without limitation, mobile phone, iPhones, PDAs, iPads, tablets, laptops, desktop computers, devices connected to key chains, devices configured to fit in a wallet or purse or other devices. Accordingly, thesystem280 may compile usage data over time to process and evaluate the usage for compliance and to alert the patient when a scheduled use is due.
Typical Inhaler Types
• FIG. 2A illustrates a typical metered dose inhaler (MDI) that includes apressurized cartridge105 filled with asthma medication and a propellant, ahousing115, andmouthpiece110. The propellant is a liquefied gas that allows the medication to be delivered in aerosol form. The asthma medication is typically suspended or dissolved in the propellant. When a patient actuates thecartridge105 to breathe in the mediation, the valve opens allowing the propellant and suspended medication particles to rapidly exit themouthpiece110 in tiny droplets. After exiting the nozzle, the propellant evaporates rapidly while leaving behind an aerosol mist of asthma medication. The patient then deeply breathes in the aerosolized medication, which reduces inflammation of the lungs and dilates the bronchioles.
• A patient is instructed to administer the medication with anMDI inhaler100 through a specific series of steps in order for the medication to properly enter the lungs and reduce asthmatic systems. Particularly, the density of the propellant and the asthma medication are typically different, causing the two to separate insideMDI inhalers100. Accordingly, a patient typically must first vigorously shake theinhaler100 immediately before use to ensure the asthma medication is evenly suspended in the propellant. Next, a patient typically holds themouthpiece110 near their mouth while squeezing the top and bottom of theMDI inhaler100 together. This opens the metered valve on theMDI100 allowing the propellant and medication to exit. Once the pressurized contents exit the canister, the surface of the canister noticeably cools due to Charles law as discussed herein. Finally, the patient then breathes in the medication to allow it to enter their lungs and act on their bronchioles. Failure to shake anMDI inhaler100 before dispensing can result in the patient inhaling too small or large of a dose of medication as it may be distributed unevenly inside thecartridge105. This is particularly troublesome for daily-dose asthma medication, which depends on consistence and regularity of treatments.
• FIG. 2B illustrates a typically dry powdered inhaler (DPI). TheDPI inhaler100 actuates each dose through a mechanical lever and spooling system.DPI inhalers100 generally contain a coiled strip with individual packets of medication. As a patient activates a DPI inhaler for each use, the coiled strip is unwound to expose a new packet, the packet is opened, and the patient breathes in the medication. The packets are enclosed by a foil covering that is continually peeled off, packet-by-packet, as the patient actuates theinhaler100 for each use. The packets each contain a dry powdered form of medication that may be breathed in by way of the airflow created by the patient's lungs.
• A patient is instructed to administer the medication with aDPI inhaler100 through a specific series of steps in order for the medication to properly enter the lungs and reduce asthmatic systems. Particularly, during operation, aDPI disc inhaler100 must typically be held level, to prevent the powdered medication from clogging the inhaler or dispersing before inhaled by the patient. Additionally, the powder must typically be in the appropriate position in order for the patient-created airflow to force the powder into the patient lungs.
• While holding theinhaler100 level, a patient first presses on thethumb pad125 to rotate themain body140 of the DPI inhaler inside of thecover125 in order to expose themouthpiece110 and alever130. This action creates a clicking sound and associated motion of theDPI inhaler100. Next, a patient slides alever130 which rotates an internal gear system, peeling off a covering of the next medication packet on the coiled strip and positioning the packet in front of an airway passage that exits through themouthpiece110. The sliding of thelever130 creates an additional clicking sound and distinct motion of theDPI inhaler100. The patient then brings themouthpiece110 to their mouth, and inhales the medication to allow it to enter the lungs.
• FIGS. 2C-2E illustrate examples ofnebulizer inhalers100. Nebulizers typically include electromechanical or compressor-based methods of transforming a liquid medication into an aerosol or droplets. For example, some nebulizers utilize a compressor that forces compressed air through a valve in fluid communication with the liquid medication. This draws the medication through the valve and transforms it into a mist that may be breathed in by a patient through a facemask ormouthpiece110. The medication may flow through atube112 to reach themouthpiece110. Piezoelectric nebulizers are another example that are illustrated inFIG. 2D. Theseinhalers100 typically use a piezoelectric system to vibrate liquid medication sufficiently to create a mist that may be inhaled.FIG. 2E illustrates a perspective view of anexample nebulizer inhaler100 that uses an internal piston compressor.
• In order to administer medication with anebulizer inhaler100, a patient powers on the device by turning on the compressor or powering on the piezoelectric element. This creates a distinct audible sound and vibration. Next, the patient brings themouthpiece110 toward their mouth (extending the tube112), and inhales the medication that has moved through thetube112 to themouthpiece110.
• A patient's use of each type ofinhaler100 typically requires a distinct series of movements or results in a series of movements, stages, sounds, temperature changes, environmental characteristics or changes, and other things associated with the inhaler or its usage. The inhaler may be evaluated by amonitor200 attached to each type of inhaler and analyzed to determine whether, when, and how aninhaler100 is used. Thus, the patient and health care providers may monitor compliance with the prescribed dosing regimen, and provide the patient with many additional benefits as described herein.
• Accordingly, for each type of inhaler, examples are described herein of how the inhaler may be monitored and processed to confirm whether use has occurred. However, these examples are only illustrations, and other aspects of the inhaler or things associated with its usage may be additionally monitored or validated. Moreover, these aspects may be monitored or validated in different orders and logic sequences to track usage and/or encourage proper dosing regimens. Finally, the various examples provided herein of particular types ofinhalers100 are merely illustrative and the concepts described with respect to oneinhaler type100 may be applied, if appropriate, toadditional inhaler100 types. Accordingly, the examples provided herein are not intended to be limiting or exclusive embodiments of an asthma inhalercompliance monitoring system105.
Compliance Monitor Design—MDI Inhaler
• FIGS. 3A-3G illustrate various embodiments of themonitor200 design and potential placement on anMDI inhaler100. (A monitor may include multiple sensors packaged together—one or more may be configured to detect motion and/or orientation, one or more may be configured to detect heat, one or more may be configured to detect sound, the package may include some ability to process or convert signals from analog to digital or digital to analog, the package may include transmission circuitry, the package may include a memory to record sensor data, etc.). A manufacturer may configure themonitor200 to be removably connectable to any appropriate location on aninhaler100. Particularly, themonitor200 may be placed in locations that are conducive to monitoring characteristics indicative of whether usage has occurred. In some embodiments, themonitor200 may be permanently attached to aninhaler100.
• For example, themonitor200 may be a cap or ring, connectable to thereplaceable cartridge105 as illustrated inFIGS. 3A-3B. This configuration can take several forms, including a cap retained by a magnet connecting it to themetal cartridge105. Additionally, thecap200 may have a rubber or friction mount that tightens or constricts around thecartridge105. The opening of thecap200 may include a cylindrical opening sized to allow for the cartridge to be inserted inside the cap.
• In this configuration, in addition to measuring motion and sound, themonitor200 can sense the casing temperature of thecartridge105. This is due to the fact that themonitor200 is in tactile contact with and rigidly coupled thecartridge105. Thus, a cartridgethermal sensor230 can be positioned to sense thecartridge105 temperature. This advantageously allows thesystem280 to confirm that medication has actually been dispensed and can provide additional confirmation that usage has occurred.
• Additionally, the amount the temperature of thecartridge105 decreases may be correlated to the amount of medication dispensed. Thus, the amount of aerosol and medication that exited thecartridge105 may be approximated based on a reading from the temperature sensor. Finally, this data can be validated with audio data including by detecting the sound of the aerosol exiting themouthpiece110. From this data, whether the metered dose properly delivered the correct quantity may be determined. For example, an empty or nearlyempty cartridge105 may not deliver as much aerosolized medication, prompting the system to deliver a warning to the patient.
• Furthermore, the cap orring200 connected to thecartridge105 may incorporate an infra-red oralthermal sensor225 aimed towards themouthpiece110 to potentially detect whether a user's mouth comes within close proximity to themouthpiece110. Also, thethermal sensor225 may detect heat changes caused by inspiration and exhalation. For example, a preparatory exhalation near the inhaler may cause the temperature to rise due to condensation or the temperature of air exiting the lungs. Upon inspiration, the temperature may then decrease due to evaporation or cooler air entering the mouth and being sensed by thethermal sensor225. Additionally, the infrared oralthermal sensor225 may be aimed at detecting heat signatures of other parts of the face, including the eyeballs, nose, and forehead.
• A health care provider may advantageously configure themonitor200 to sense when it is removed from aninhaler100. Capacitance sensors, mechanical push button monitors, infra-red range sensor or other suitable sensors known in the art can be used to determine when themonitor200 is removed and attached to anew inhaler100. Once themonitor200 has been replaced, a notification can pop up on the patient'smobile device150 requesting the patient confirm whether themonitor200 has been installed on a new inhaler. This feature is advantageous to alert therefill monitoring system800 that a refill has been inserted and to restart the usage count.
• In addition to placement on the canister, themonitor200 may also be placed on thehousing115 of theinhaler100. This may be accomplished through a ring configuration, a cap configuration or other suitable mechanical components for connecting themonitor200 to thehousing115. Additionally, in any configuration, amonitor200 may be removably connectable to aninhaler100.
• While connected to thehousing115, themonitor200 may detect the temperature drop of thecanister105 with a probe, or the associated temperature drop that is transmitted through thehousing115. Furthermore, infrared sensors may be used to sense mouth or facial heat signatures. Themonitor200 may also have a motion sensor to detect the motion signature typical for removing thecartridge105 from theinhaler100.
• A manufacture may also configure amonitor200 to be connectable to aninhaler100 near themouthpiece110 as illustrated inFIG. 3D. In this configuration, in addition to the other characteristics described above that can be detected, amonitor200 can be placed in an advantageous location to detect the heat signature from a patient's mouth during use. For example, amonitor200 may have an infra-red temperature sensor225 aimed along the line of sight of themouthpiece110. Thus, when a patient opens their mouth to use aninhaler100, the infra-red temperature sensor225 detects the increased temperature inside the mouth. This can be particularly advantageous, as the mouth typically has a higher temperature than a patient's surrounding skin. Accordingly, placement of themonitor200 alongside themouthpiece110 can allow themonitor200 to have an advantageous line of sight to a patient's mouth. Additionally, with themonitor200 in this location, or other locations described herein, themonitor200 may also include a contact, oralthermal sensor225 that may be placed near themouthpiece110. Accordingly, the oral,thermal sensor225 may then detect the temperature increase caused by the patient's mouth during use due to contact of the mouth with the oral,thermal sensor225. In this configuration, themonitor200 can also detect sound, motion, temperature of thehousing115, and the additional characteristics mentioned for other configurations and types of monitors herein.
• A manufacturer may also configure amonitor200 to be in the shape of a clip as illustrated inFIGS. 3E-F. In this embodiment, themonitor200 may include aslender portion205 of aclip monitor200 that slides between theinhaler cartridge105 and theinhaler housing115. The clip monitor200 may include an oral or infra-red temperature sensor225. The infra-red sensor225 may be connected near the end of aslender portion205, in order to be placed near the opening of themouthpiece110. Additionally, the infra-red sensor225 may be aimed out themouthpiece110 from inside in a direction that allows the infra-red sensor225 to detect the heat signature of an open mouth or inhalation and exhalation during administration of medication. Additionally, atemperature sensor225 may be located on the portion of themonitor200 not contained inside theinhaler housing115. For example, the temperature sensor may be located in a position that has a line of sight to a patient's mouth while a patient is inhaling medication. The clip monitor200 may fasten to theinhaler housing115 by pressure created by a plastic or spring loaded hinge incorporated into a clip incorporated into amonitor200. This pressure may be created between a slender portion and anelectronics compartment245 once theclip monitor200 is attached to theinhaler housing115. Theelectronics compartment245 may enclose some or a majority of the electronics of themonitor200. Theelectronics compartment245 may be connected to theslender portion205 and may be configured to sit outside theinhaler housing115.
Compliance Monitor Design—DPI Inhaler
• FIGS. 4A-4I illustrate examples ofmonitors200 configured to detect usage of a dry powdered disc inhaler100 (DPI). A manufacturer may configure amonitor200 to be connected to various appropriate portions of aDPI inhaler100. For example,FIG. 4A illustrates amonitor200 connected to acover125 or top portion of theDPI inhaler100. Placement on thecover125 can allow amonitor200 to avoid interference with the moving parts when themain body140 of theinhaler100 is rotated within the cover125 (e.g., using the slideable lever130).
• In some examples, themonitor200 may be constructed with a slim enough profile to be connected near themouthpiece110 or other areas of themain body140 of aDPI inhaler100. For example,FIG. 4B shows a monitor attached to the side of the DPI inhaler not far from themouthpiece110. Amonitor200 may exhibit a low enough profile to avoid interference with thecover125 when it is rotated back over themouthpiece110 andlever130. Placement near themouthpiece110, as described above for other types of inhalers, can allow contact or infra-red, oral,thermal sensors225 in electrically communication withmonitor200 to detect presence of the open mouth.
• Amonitor200 may also be configured to clip on to alever130. This configuration can allow themonitor200 to detect the motion oflever130 as it is slid forward to actuate theinhaler100. Also, the motion and sound created by the click is advantageously detectable in this configuration. Furthermore, in this location, amonitor200 may also detect the temperature of the open mouth through temperature monitors as discussed herein and detect clicks and audio sounds that typically accompany actuation of theDPI inhaler100.
• Amonitor200 may additionally be configured as a clip that fits over the top and bottom portions of theDPI inhaler100 as illustrated inFIGS. 4C-E. The clip is illustrated alone inFIG. 4C. The clip is illustrated as attached to a DPI inhaler in the example ofFIG. 4D, and a side view of this same example is shown inFIG. 4E. The clip configuration may include capacitance sensors on the top, bottom or on both positions that sense when a conductive medium touches theinhaler100, such as human hands in preparation for usage. This capacitance data may provide an additional or substitute confirmation of usage as discussed herein. Additionally, various sensors may be integrated throughout the clip housing. In these figures, anoral temperature sensor225 is helpfully located and oriented with a good vantage point near themouthpiece110.
• The design illustrated inFIGS. 4C,4D, and4E can be particularly useful because: it can be easy to install and remove; it can use less raw material and is therefore potentially less expensive to manufacture; it has a small profile and may be less intrusive to a user; it can have an easily-removed mount to the housing and avoid use of adhesives; the method of dosing medications can be unchanged from instructions provided by the DPI manufacturer; it can support a temperature sensor positioned well for pointing toward the face or mouth of a user; the opening and closing movements of a user can remain the same as they would be without this attachment.
• Themonitor200 may be configured to cover much or most of the entireDPI inhaler cover125 as illustrated inFIG. 4F-4I. These embodiments are advantageous because themonitor200 is reliably attached to the inhaler cover as the sensor covers theentire DPI cover125. The various sensors, including capacitance sensors, may be integrated throughout.
• The embodiment ofFIGS. 4F and 4G can create an all-in-one device that would simply slide onto an DPI such as a Diskus inhaler. As shown in the figures, it feels and looks similar to the cover that the Diskus currently has but allows external sensors without the user having to worry about placement. These sensors may include contact temperature sensors, temperature switches, microphones or any other type of sensor. It can be designed to include a housing/mount interface or be an all-in-one device. The IR sensor can be pointed toward the users face. The design could help inhibit improper installation. The embodiment ofFIGS. 4F and 4G can have the following features and advantages: easy to install and remove; it may include external sensors; it would provide space for inclusion of specific instructions to a user; it can be a mount/housing interface or an all-in-one housing; it can employ temperature switches for power saving; it can allow users to use the same dosing protocol and actions; and it can avoid a need for users to place any external sensors.
• FIG. 4H andFIG. 4I show an embodiment having a cover that encompasses the whole Diskus (except for said mouth piece). Themonitor200 may include a door that may open and close to cover and/or reveal themouthpiece110. The door may open and close as needed for a patient to dispense the medication from theinhaler100. Additionally, the door may contain itsown motion sensor210 and thesensor200 body may also contain amotion210 and relative motion between the two sensors may be indicative that the door is being opened. As indicated inFIG. 4H, the door may be opened by asensor lever275 connected to the sensor housing. Accordingly, detection of rotational motion a certain angle θ of sensor lever with respect to a sensor cover would indicate theinhaler100 has likely been used. Example sensors useful for this embodiment can include, e.g., an accelerometer, magnetometer, gyroscope, and IR temperature sensor. In the plan view ofFIG. 4H, dashed lines indicate the hidden shape of the DPI inhaler underneath the example monitor200 that surrounds and encloses nearly the entire DPI inhaler.
• FIG. 4I illustrates a schematic cross-section view of an example of a construction of amonitor200 that covers the entireDPI inhaler cover125. Themonitor200 includes two halves that may be snapped together with the illustrated hook system or any other suitable mechanical, magnetic, or other connection.
• The design illustrated inFIG. 4H andFIG. 4I can be particularly useful because: its full coverage and extensive coverage allows placement of one or more external sensors where they may be desired; sensors can be pre-installed by a manufacturer with no requirement that users position sensors; a user only has to perform one additional action—use the lever to open the cover; installation can be simple (e.g., only one way to fit) and inhibit the potential for errors; there may be a reduced need for an external gyroscopic sensor if the housing itself moves; a temperature sensor can rotate, thereby allowing the sensor to sense a temperature gradient (if the sensor has a cover, this gradient can be amplified); the cover may be secure and unlikely to be dislodged inadvertently; it can helpfully obscure instructions from the original DPI provider so that the updated instructions that account for use of the cover are more prominently accessible and/or visible to a user.
• FIG. 4J illustrates how some embodiments can have a sensor or group of sensors together in a single disk-shaped attachment that is secured to piggy-back directly on the flat back of the DPI. This design can be relatively minimal. This design contains a window for IR temperature sensor(s) such as those described above with respect to other designs. Installation may include proper alignment before adhesion. Sensors that can be included for effective use of this low-profile design can be an accelerometer, an IR temperature sensor, and a microphone. The design illustrated inFIG. 4J can be particularly useful because: it is low profile and non-intrusive; it does not alter usage of the underlying DPI; it involves few materials and can therefore involve low manufacturing costs; it can readily orient a temperature sensor toward the face and/or mouth.
Compliance Monitor Design—Nebulizer Inhaler
• FIGS. 5 and 6 illustrate examples of amonitor200 integrated configured to detect usage of anebulizer inhaler100. A manufacturer may configure amonitor200 to be removably connectable to various locations along anebulizer inhaler100. For example, themonitor200 may be placed near themouthpiece110. This placement can facilitate thermal detection of the open mouth during usage as discussed herein.
• Additionally, amonitor200 may be placed on acompressor120 that may be associated with thenebulizer inhaler100. In this configuration, amonitor200 may detect the vibration and noise generated from the compressor to verify use. As discussed above, anebulizer inhaler100 has a motion generating element that creates significant noise. Amonitor200 may monitor these elements to record the total time thenebulizer inhaler100 is in use. In a configuration where themonitor200 is attached to thecompressor120, the manufacturer may also include a probe that is wired or wirelessly connected to a mask ormouthpiece110 associated with thenebulizer inhaler100. Integrating a probe near themouthpiece110 will allow themonitor110 to confirm usage by detecting the heat signature of the mouth or facial area, once the user breathes through themouthpiece110 or facemask. Additionally, themonitor200 may include ahumidity sensor550 that can detect increased humidity from the mist created through thenebulizer inhaler100 or from the patient exhaling.
• Monitor200 is a broad term, and may include self-contained monitoring equipment stored within a housing, separate components and sensors that are physically divided but operate in conjunction through electronic communication, multiple sensors packaged together as described above, or other configurations. Manufactures may construct amonitor200 from any suitable materials including, biocompatible medical grade material, water resistant materials and constructions, plastics, metal, or others known in the art. In some embodiments, manufacturers will fabricate amonitor200 to be completely self-contained with no moving parts to remove openings that may become contaminated or decrease the life ofmonitor200. Particularly, amonitor200 may not have any mechanically actuated usage sensors such as a switch. Accordingly, amonitor200 may be designed to avoid moving parts, which can allow it to be sealed to liquids, moisture and other contaminants during operation. Including fewer moving parts can also decrease the chances of mechanical failure.
Overview of Compliance Monitor Design
• FIG. 7 illustrates an overview of an example of the some components that may be incorporated into amonitor200. Themonitor200 may include acontroller235 that controls the various functions of themonitor200.Controller235 is a broad term and may include any computing device or simple circuitry for executing instructions, including but not limited to, microcontrollers, microprocessors, and others.Controller235 may be amaster controller235 or aslave controller235 that is directed by another computing device in electronic communication with thecontroller235.
• Themonitor200 may include various temperature sensors as illustrated inFIG. 7. For example, themonitor200 may include anoral temperature sensor225. Anoral temperature sensor225 may be any temperature sensor that is configurable to measure or detect the thermal increase associated with the close proximity of a patient's mouth to amouthpiece110 or mask during use of aninhaler100, or from inhalation and exhalation. For example, theoral temperature sensor225 may incorporate an infra-red thermal sensor that is aimed in a direction that has a clear line of sight to a patient's mouth when opened in position forinhaler100 usage. In addition, the oralthermal sensor225 may also be a contact sensor that can sense the temperature of the patient's mouth contacting amouthpiece110.Oral temperature sensor225 may be any suitable thermal sensor.
• Themonitor200 may also incorporate acartridge temperature sensor230. Acartridge temperature sensor230 may be any suitable temperature sensor. For example, acartridge temperature sensor230 may be an infra-red temperature sensor that is aimed at the surface of thecartridge105. This configuration can allow thecartridge temperature sensor230 to be placed remote from thecartridge105 while still sensing its temperature. For example, if themonitor200 is placed on amouthpiece110, thecartridge temperature sensor230 may be aimed at thecartridge105, while theoral temperature sensor230 can be aimed at the location of the open mouth during usage. Additionally,cartridge temperature sensor230 may include a probe connected with a wired or wireless connection to monitor200. In some embodiments,cartridge temperature sensor225 may be a contact thermal monitor placed near thecartridge105.
• Themonitor200 may also include anambient temperature sensor220. Anambient temperature sensor220 may be any suitable temperature sensor, including thermometers, thermistors, and others. Data derived from anambient temperature sensor220 may be useful to compare with the data from anoral temperature sensor225 and thecartridge temperature sensor230 to validate usage.
• Themonitor200 may also include anaudio sensor215, for detecting the sounds generated by a patient andinhaler100 during use of the device. For example, anaudio sensor215 may detect sound waves created by inhalation of the patient during usage, the clicks of theDPI inhaler100 during usage, aerosol exiting theMDI inhaler100, operation of the generator or piezoelectric motors in thenebulizer inhaler100, and other sounds indicative of use.
• Amonitor200 may also incorporate various motion sensors known in the art. For example, themonitor200 may incorporate an accelerometer, gyroscope, magnetometer, acceleration switches, tilt switches, or any other motion and orientation sensing device that is known in the art or hereinafter developed. Incorporation ofmotion sensors210 will allow amonitor200 to detect certain movements and orientations of aninhaler100 with respect to gravity that are characteristic of or required for usage. These movements will vary for each type ofinhaler100, and the algorithms for analysis may be modified accordingly depending on the type ofinhaler100.
• The manufacturer of amonitor200 may also incorporate various visual and audio displays and alerts. For example, audio andvisual alert240 capabilities may be included with speakers, LEDs, or other notification systems and methods known in the art. Additionally, amonitor200 may include adisplay260. Adisplay260 may include a full LCD screen display, or a simple analog or digital readout. In some, embodiments, amonitor200 has nodisplay260.
• Amonitor200 may also incorporate abattery270 andmemory265. Thebattery270 may be any suitable battery, including a CR2032 button cell battery or others. Thememory265 may be any suitable data storage device, including volatile memory types such as random access memory, DRAM, SDRAM, and others. If volatile memory is utilized, monitor200 may continually transmit information to an associated component of thesystem280 in order to store data collected bymonitor200.Memory265 may also include non-volatile memory, including read only memory, EEPROM, flash memory, optical and magnetic computer memory storage devices, and others.
• Thememory265 may store computer modules or other software for implementing the functions ofmonitor200 described herein. Additionally,memory265 may store data collected by the various sensors associated withmonitor200. This data may be continually transmitted to associated devices for long term storage or stored onmemory265 until downloaded by connecting another device to monitor200. In some embodiments, monitor200 may be a self-contained unit that includes compliance monitoring software andsufficient memory265 to store usage and sensor data for a patient.
• A manufacturer may also include electronic communication systems and methods formonitor200 including a wired155 andwireless link250. Wireless link155 may incorporate any suitable wireless connection technology known in the art, including but not limited to Wi-Fi (IEEE 802.11), Bluetooth, other radio frequencies, Infra-Red (IR), GSM, CDMA, GPRS, 3G, 4G, W-CDMA, EDGE or DCDMA200 and similar technologies. Additionally, the systems for electronic communication may include awired connection255 or various ports, including RS-232, or other standard communication technology known in the art.
Compliance Monitor Mobile Application
• FIG. 8 illustrates amonitor200 in wireless communication with anapplication300 installed on amobile device150. This configuration advantageously permits, in some embodiments, the data compilation and analysis to be performed on a patient'smobile device150 or on other systems in communication with theapplication300 on patient's mobile device. Additionally, integration with amobile device150 can allow themonitor200 to utilize the various sensors and other capabilities already present on manymobile devices150 including location sensing capability, date and time recording and association with individual uses, and connection to the internet. Amonitor200 may be in communication with anapplication300 onmobile device150 throughwireless link250 or awired connection255. In some embodiments, amonitor200 transmits usage data collected via sensors or processed bycontroller235 and associated modules.
• Additionally,application300 may send instructions tocontroller235 or provide new firmware or software to monitor200. For example, if user purchases a different type ofinhaler100, theapplication300 may provide an option for downloading appropriate algorithms and logic for determining usage tailored to the new inhaler. Additionally, anapplication300 may send instructions to activate audio orvisual alerts240, to present certain information on adisplay260, or to power on amonitor200.
• An asthmacompliance monitoring system280 may include logic to evaluate whether use has occurred based on certain characteristics sensed by the sensors and sensors of amonitor200 that are associated with use. The logic and characteristics detected to evaluate use vary and also may be modified to accommodate particular types ofinhalers100. Accordingly, the examples described below are merely illustrations, and the features of the various examples given may be interchanged, switched, replaced, combined, and modified appropriately.
Example Hardware FeaturesDevice
• Various products and systems can be made according to this disclosure. Some relevant products can leverage existing computational power available in smart phones, for example, by providing a small hardware module that can communicate wirelessly with a smart phone running a software application. Such a system's objectives can include the ability to detect the usage, by an individual, of one or more asthma medication modalities, which may include the Metered Dose Inhaler (MDI), Disk Inhaler (Diskus) and the Nebulizer. As noted above, different mounting structures can be provided that allow a small hardware module (see, e.g., themonitor200 ofFIGS. 16 and 17) to attach to various styles of inhaler. Such a universal sensor can house several different sensors while having pins to interface with external sensors.
• Some basic features of a modular commercial device (an example of which may be referred to as the “ClickSonea” device) that may exhibit some of the advantages discussed herein, may include those set forth below. The device can pair with a smart phone via Bluetooth. Once paired, the device may send data to the smart phone automatically. The device may be able to be mounted on three different asthma medication devices; the metered dose inhaler, the disk inhaler and the nebulizer. While mounted, the device may be able to detect and recognize when the device has been used or is currently being used by the individual depending on the medication device in use. Various sensors may be used to determine when the device has been, or is being, used; multiple sensors may be useful to filter out false positives. Data received from the sensors may be processed on-board the device. Data may be sent from the device to a portable computing device (e.g., operating on an Android or iOS platform) via a wired or wireless protocol (e.g., a Low Energy Bluetooth connection, Bluetooth (BLE 4.0), etc.); data sent to the smart phone can include a timestamp and the medication used.
• It will often be advantageous to mount a modular device (such as the one discussed above) on an inhaler. Many approaches to mounting are advantageously tightly and rigidly mechanically coupled with respect to a physical, rigid out portion of an inhaler. This is helpful if the modular device includes motion sensors such as accelerometers, gyroscopes, and the like because a close mechanical coupling can help provide more relevant data: when the inhaler moves, tilts, etc., the modular device moves, tilts, etc. in the same manner or direction.
• Systems such as described herein can be especially useful if they take into account human factors. For example, the design can advantageously account for users taking their medication via: a metered-dose inhaler (medications can be controller medication, as-needed medication, and/or rescue medication); a disk inhaler; and/or a nebulizer.
• When mounted on a MDI, for example, a modular device may be able to recognize: the inhaler being shaken; and/or that the inhaler is being or has been pressed (e.g., without requiring the use of a button). For a disk inhaler, a device may be able to recognize: the opening and closing of the disk; when the medicine has been dispensed (through recognition of lever being pushed); when the disk is being held up to the users face; and/or when the disk (or device) is being held parallel to the horizontal axis. When mounted on an asthma nebulizer, the modular device may be able to recognize: relative change in humidity while the nebulizer is being used; change in temperature of the nebulizer tubes while the user is breathing through the device; when the device is being held up to the user's face; and/or when the device is turned off.
• Some embodiments of a hardware device may be referred to as a “ClickSonea” device and may have the following physical description: dimensions (of MDI version): no greater than (10×27×18 mm); weight: No more than 30 grams; attachable (and, potentially, detachable), to and from, each individual inhaler type; all parts may be made out of biocompatible medical grade material; shaped as a rectangular prism with the dimensions given above; water resistant.
• Some embodiments of a hardware device meet the following environment conditions: ambient operating temperature: Range of 0° to 60° C.; storage temperature:Range 20° to 25° C.; humidity: 0-70% RH; altitude: −200 m to +2000 m.
• The hardware can include a printed circuit board (e.g., as part of or to interface with a microcontroller). To be environmentally-friendly, the PCB (Printed Circuit Board) may comply with RoHS lead-free standards. It may consume no current during off time from the main battery. The device may contain a single PCBA (Printed Circuit Board Assembly), which contains sensors, an embedded microcontroller and a digital to digital converter. In some cases a digital to digital converter can be used because the CC2541 SensorTag Dev kit uses such a converter. Other boards based on the 8051 MCU, for example, may also employ a digital to digital converter.
Power Management
• The device may have a replaceable battery, or in some embodiments, it may not have a replaceable battery and may be discarded after the battery dies. The battery itself may last an appropriate length of time. For example, it may be designed to last around a year. It may be selected or configured to last for the entire lifespan of the longest or most demanding medication type. For example detecting ashake event 200 times for a metered dose inhaler may be the most demanding. In some embodiments, the device may have: a CR2032 button cell battery; anaverage battery 1 of year of use; and/or low power consumption.
• Regarding consumables/disposables, the hardware may be a ‘green’ device. It may meet biocompatible standards. The battery life may be at least one year, for example. Meeting these standards, the device may be disposable after the battery life is ended and a new one may be bought. The device may be designed to be an affordable and disposable solution for tracking asthma medication use. Regarding reliability, the mean time between failures (MTBF) of the device may be longer than 30,000 hours. (This may be wall clock hours or use hours).
Example Software FeaturesApplication
• A software application can be used to communicate with and process information from the modular hardware device described above. The software may, for example, be referred to as a “ClickSonea App.” The software may be: qualified by one or more smart phone manufacturers; launched automatically once the hardware device is paired with the smart phone; and/or the main console for the operator. The software application may provide all necessary instructions. The software application may allow an operator to initiate a data collection sequence by use of a predefined action (such as shaking the MDI). Moreover, a software application may gather data on whether the inhaler device has been, or is being used; forward the validated data to a web portal for further analysis; display any feedback to the user upon reception from the web portal; allow operators to be authenticated before accessing the software application; and/or allow communication between the software application and web portal to be encrypted.
Example Software FeaturesWeb Portal
• A web portal related to the above software and hardware may: provide for a web interface for operators to manage their accounts; allow for storage of some or all uploaded data into a secured database; provide for authentication of all access to the web portal; allow users to remotely access their account and billing information via a special or a regular web browser. All traffic may be encrypted.
• A user interface of the above hardware and software (which can together be commercialized under the name “ClickSonea System”) can provide for recording of time a stamp and location of each medication usage and be easy to use. The software as visible on a mobile phone may act as the main console interfacing with the operator. The software thus visible can, for example, announce status such as: out of battery, etc.
• The example hardware and software systems described here can connect to the following platform as hosts: Apple (iPhone 4S and 5; iPad (4th Generation), iPad mini; iPod Touch Gen 5); and/or Android (various devices on various platforms such as Jelly Bean 4.3). The web portal can, for example, be designed to be compatible with the following platforms: Linux 2.6; Apache 2.x;MYSQL 5;PHP 5; and/orZend Framework 2.
• For security purposes, the hardware and software systems comply with HIPAA, FDA and QSR requirements.
Example Hardware and Software Functionality
• Once powered up, tested and configured initially, the modular hardware device described above may be ready to pair with the smart phone. Once paired with a smart phone via Bluetooth, the software application may gain control over the hardware device. Data may be received in real-time. When a USB connection is found during power cycle, the hardware device may enter into a TEST state for testing/diagnostics once the hosted PC is authenticated. The device may be power cycled after production testing. Firmware of the hardware device could be reprogrammed during the TEST state. If the device is not connected to the smart phone via Bluetooth, the device may store the data and send only when the Bluetooth connection is reestablished.
• The software application may be capable of gathering data from the hardware device, forwarding data to the web portal, and displaying any feedback. Though the software gathers data from the hardware device automatically, the user may also be able to input their own data in case the system does not detect a usage at the appropriate time. When the hardware device detects that the inhaler has been used it may ask for confirmation from the user in order to filter out false positives.
• The web portal may: provide account and billing management for authenticated operators; log measurement results on designated ClickSonea Web accounts; and/or be compatible with a web portal such as the AirSonea Web Portal. A single user name and password may be needed to view data (e.g., data derived from and or visible to or from different devices—the modular hardware, a smart phone running the software application, or another machine running the software or storing related data). User names, passwords, and central user accounts may facilitate payment options and managing accounts. A web portal may allow the user to remove their data from the database and it may allow users to close their account.
Sensors in the Example Hardware
• The module device hardware described here can include sensors. Locating the sensors within the device itself can be helpful to avoid tampering. Hardwired sensors can also avoid a need for a user to perform calibrations. In some embodiments, once the device is attached to the appropriate mount all that is needed is to use the medication as normal. The device may have an accelerometer, gyroscope and magnetometer on board. These sensors may be used individually to detect specific movements or in combination to detect change in relative position in 3-D space. In order to detect temperature and temperature changes, the device may include an on-board IR temperature sensor.
• In order to achieve the above features and functionality for the hardware, software, web portal, and system, multiple sensors may be used, which may be on-board and/or external to the modular hardware device. The sensors may interface with the system: (1) the on-board sensors may interface directly with a CC2541 System-On-Chip (SOC) through an I2C interface (e.g., an inter-integrated circuit such as a multimaster serial single-ended computer bus used for attaching low-speed peripherals to an embedded system); and/or (2) external sensors may interface via GPIO, or some other pin interface, with the modular hardware device.
• FIG. 9 illustrates an example system architecture diagram for the sensors. A power source410 (e.g., a CR 2032 battery) can interface or communicate with a converter412 (e.g., a DC/DC TPS 62730). A processor414 (e.g., a CC2541 system-on-chip) can interface with other devices using GPIO pins416, for example.External sensors418 can communicate with theprocessor414 via the pins416.Such sensors418 can include contact sensors, for example. Aswitch420 can be a tilt switch. It can help determine when theprocessor414 should draw power from thepower source410, thereby allowing theprocessor414 to maintain a sleep mode at relevant times, saving energy. Analert system422 can be a feedback system of any kind, such as a visual alert system comprising one or more light-emitting diodes. Theprocessor414 can be use an I2C interface (e.g., an inter-integrated circuit) to communicate with one or more sensors, such as anaccelerometer424, agyroscope426, amagnetometer428, anIR temperature sensor430, and orother sensors432. Each of the specific items in this figure is merely an example. Thus, e.g., in place of or in addition to the CC2541, another processor and/or microcontroller can be included.
• In the context ofFIG. 9, a system may include the following specific subsystems: (1) multiple MEMS sensors (e.g., sensors424-423) including, but not limited to,IR temperature sensor430,accelerometer424,gyroscope426,magnetometer428, and humidity sensor; (2) on-board flash program memory capable of being programmed by USB connection to a host computer. (This programming feature can be the same or similar to the TEST mode referred to earlier. It can be used for firmware updates, for example. This function may be available for end-users, a manufacturer, and/or a health-care provider, for example); (3) bluetooth interface; (4) tilt switch (e.g., switch420); and/or (5) LED element that aids in communicating the status of the device to the customer (ready, done, power on, etc.)—e.g.,alert system422.
• FIG. 10 illustrates an example of how a modular device may be able to interface with different types of inhalers and may be able to distinguish between them. In order to effectively filter out false positives, it may be helpful to have external sensors on the mounts for the different inhalers. These sensors may provide additional data to the modular device and may not necessarily be needed for all inhalers. InFIG. 10, amicrocontroller440 is physically associated with amodular device housing442. Themicrocontroller440 can communicate with and/or be attached toexternal sensors454,464, and474. Variousdetachable interfaces444 can be used to associate themodular device housing442 with an MDI mount450 (which, in turn mounts to a metered dose inhaler452), a disk inhaler mount460 (which, in turn mounts to a dry powder disk inhaler462), and/or a nebulizer mount470 (which, in turn mounts to an asthma nebulizer). The mounts and interfaces referred to here can be those illustrated in the figures above, for example. Each mount can have an associated external sensor, as shown with the lines connecting theMDI mount450 to thesensor454, thedisk inhaler mount460 with theexternal sensor464, and thenebulizer mount470 to theexternal sensor474.
• Regarding signal acquisition, processing, and communication, the device may accept data from, for example, 4 sensors (IR Temp., Gyro, Accel, and Magnetometer). Other sensors may be added through GPIOs in order to capture specific data from specific devices). The signals captured from the data may be processed on-board the microcontroller on the device. All data may be processed in real time. The device may communicate via Bluetooth 4.0 to smart phone devices. It may interface with the on-board sensors via an I2C bus and external sensors via GPIO pins.
Combined System Overview
• FIG. 11 illustrates an example system overview of how adevice480,software application486 running on a portable electronic device such as asmartphone484, andweb portal490 can work together. Thedevice480 can be attached to multiple types of asthma inhalers (e.g., the illustrated metered-dose inhaler456,disk inhaler466, and/or nebulizer476). Thedevice480 can keep track of medication usage through the use of different MEMS (micro-electronic mechanical sensors). The sensors include, but are not limited to, IR temperature sensor, humidity sensor, accelerometer, gyroscope, magnetometer, and a contact temperature sensor. Thedevice480 may gather data from these sensors and run the appropriate algorithms to check if the inhaler has been, or is being, used. The confirmation of the inhaler being used may be sent to the pairedsmart phone484.
• Resident in the memory of asmart phone484, thesoftware application486 may interface with the device480 (e.g., wirelessly using Bluetooth 4.0). The software can provide the main console interfacing with the user. Data from the sensors may be processed and use of the inhaler may be detected. Notification of inhaler use may be sent to the smart phone, which may in turn forward this information to theweb portal490 via a network310 (e.g., through the internet or a worldwide web connection).
• Theweb portal490 can be a cloud server running on the internet. Upon reception of the confirmation data from authenticated operators, the web portal490 (and/or a processor associated therewith) may analyze the data and store it in adatabase492. This database can be accessed and it may return and display feedback to the user through thesoftware application486.
• The system described herein may be helpful for use in both clinical and home environments. It is helpful for a single patient, multiple medication use device to provide medication usage information. The system is useful for both pediatric and adult patients, for example.
Safety and Regulatory Considerations
• The systems described herein may meet standard medical and consumer safety standards and may comply with electrical immunity and susceptibility standards. They may meet the following standards: Biological Evaluation of Medical Devices (Biocompatibility), ISO 10993-1:2003; MDD Council Directive concerning medical devices, 93/42/EEC; Safety of Medical and Dental Equipment, UL 2601-1; Graphic Symbols for use in the Labeling of Medical Devices, EN 980:2003; Information supplied by the manufacturer with Medical Devices, EN 1041:1998; Clinical Investigation of Medical Devices for Human Subjects, EN ISO 14155:2003; Clinical Investigation of Medical Devices for Human Subjects, BS EN 540:1993; Test of immunity from electrostatic discharge (ESD), IEC 801-2:1994; Electrical Fast Transient/burst, IEC61000-4-4:1995; Safety requirements for electrical medical devices, EN60601-1:2003; Medical Electrical Equipment Electromagnetic compatibility, EN60601-1-2:2002;FCC Part 15 Certification; Bluetooth Qualification.
• The systems described herein may also satisfy regulatory constraints and features, such as: USA: FDA 510(K) OTC; European Union: CE-Medical mark; Australia: TGA. Regulations of other countries, such as Israel, China, Japan, and Brazil can also be satisfied.
Evaluating Inhaler Regimen Compliance
• FIG. 12 illustrates an example of a method for evaluating whether a patient has used aninhaler100. WhileFIG. 12 illustrates a sequence of steps for evaluating usage of an inhaler, the potential methods for evaluating compliance should not be limited to those disclosed inFIG. 12. First, a patient generally will pick up theirinhaler500 which will cause some movement detectable by themotion sensor210 onmonitor200. This will cause amonitor200 to wake up510, and begin to sense motion withmotion sensor210 to determine whether motion typical ofinhaler100 use has occurred. For example, herein are discussed various types ofinhalers100 and the associated motions that are characteristic of or required for use with each type. In one example, anMDI inhaler100 is shaken immediately prior to use. Other examples of this detection will be discussed in more detail herein. Although these motions indicate that use is likely imminent, it is possible that theinhaler100 might be shaken or moved in a certain way that is not due to use of theinhaler100. For example, the user may shake arescue inhaler100 but then determine it is not needed. Additionally, theinhaler100 may be accidentally shaken by movement from carrying or other activities in a way that is characteristic of use by coincidence. Without further validation, detection of only motion to validate usage may result in a significant number of false positives.
• Accordingly, in order to validate that use has occurred, themonitor200 may additionally sense other environmental characteristics indicative of usage, such as temperature changes. For example, if motion is detected themonitor200 may additionally activate the thermal sensors to determine whether a temperature increase characteristic of a user applying their mouth to amouthpiece110, or exhaling and inhaling. For example, experimental data has shown the there is a characteristic increase and decrease in temperature during exhalation and inhalation near an infrared temperature sensor aimed at the mouth. Accordingly, an algorithm can analyze the temperature data to determine whether an increase and decrease typical of exhalation followed by inhalation is recorded, or if there is a decrease in temperature in the case of inhalation alone. This can include certain low pass filters, other frequency filters, and certain temperature increases or decreases within a prescribed amount of time of the motion. This can provide additional verification that the patient has used theinhaler100 as a user is unlikely to put their mouth near themouthpiece110 without intending on using the device. Additionally, the sequence may also be a requirement to confirm usage. For example, themonitor200 may require that the temperature change be recorded after the motion indicating usage.
• A temperature increase near themouthpiece110 alone may not provide a reliable indicator of usage as the temperature may increase due to themouthpiece110 being in close proximity to other sources of heat. Additionally, if themotion sensor210 does not detect the prescribed shaking motion for anMDI inhaler100 but detects amouthpiece110 temperature increase, it may indicate suboptimal or failed usage. In that instance, themonitor200 may provide a notification to the patient or to an associated processor or data storage medium that usage may not have been optimal. Accordingly, data may be collected that indicates the quality of compliance in addition to the quantity.
• Alternatively, in the case of theMDI inhaler100, themonitor200 senses the temperature of thecartridge105 to determine whether a temperature decrease characteristic of anMDI inhaler100 being actuated has occurred. As discussed above, a temperature decrease detected for anMDI inhaler100 without the prescribed shaking that occurred prior to the decrease may indicate suboptimal usage. Additionally, themonitor200 may log the amount of time between the shaking of theinhaler100 and the temperature decrease of thecartridge105. This may be important to determine optimal usage as theinhaler105 typically must be actuated immediately after shaking. This is due to the fact that the propellants and medications immediately begin to stratify and separate due to their different densities inside anMDI inhaler100. Therefore, to ensure accurate and uniform dosages theinhaler100 typically must be actuated immediately after shaking Overtime, improper usage through delayed actuation after shaking may result in a patient administering incorrect dosages. Accordingly, notifications may request the patient actuate theinhaler100 quicker, or be sent to a health care provider for instructions.
• If after a certain amount of time has passed after motion indicating usage is detected, a temperature change characteristic of usage does not additionally occur, the monitor may not recordusage525. This can help eliminate additional false positives created by accidental movement that is characteristic of usage and temperature changes that are characteristic of usage. In some embodiments, the time window may be 30 seconds, 10 seconds, one minute, a few minutes or other suitable time windows. In some embodiments, the monitor will not validate the usage based on a sequence. Rather, themonitor200 will validate usage based on expected motion and temperature changes that are close in proximity but not necessarily in a specific sequence. Once themonitor200 has validated that a use has occurred through, for example, motion and temperature changes, themonitor200 records ausage525. Thedate560,time555,location565,humidity550,temperature540, and other environmental factors may be recorded and associated with the data representing that usage.
• Themonitor200 may record that data based on internal clocks and monitors, including GPS capabilities or themonitor200 may immediately send the usage information to amobile application300. Alternatively, an internal clock may date and time stamp a usage and store the usage in a memory in communication for themonitor200. Then, once a wireless connection is established between themonitor200 and themobile device150 the usage data may be downloaded to theapplication300. Additionally, using thedate560 andtime540 information already associated with the usage by amonitor200, anapplication300 may associate additional information with that usage obtained from third party sources.
• In some embodiments, environmental data associated with thedate560 and ortime555 of usage in a specific location may be obtained through an API or other interface with weather provider's servers and databases. In another example, weather information may be determined from onboard orambient temperature sensors220, humidity sensors, and other sensors. This information associated with the usage may provide important clues concerning a patient's susceptibility to triggering asthma reactions based on certain environmental factors.
• In some embodiments, themotion detection step520 may be replaced with monitors of other characteristics indicative of usage. For example, in the case of theMDI inhaler100, if the monitor is position on themain body140 and is therefore covered except during usage, themonitor100 may detect light changes. Accordingly, when a patient slides themain body140 into usage position by pressing onMDI thumb pad135, themonitor200 can detect the increase in light and indicate use is likely to occur. In some embodiments, themonitor200 can monitor the light and remind the patient to close thecover125 once usage has completed.
• The temperature sensor validation step may be supplemented and/or replaced with validation from sensors of other characteristics that are indicative of a usage. For example, ahumidity sensor550 located in close proximity to amouthpiece110 may determine that the mouth is in close proximity based on the increased humidity from exhaled air. Additionally or alternatively, capacitance may be used to validate usage, especially for embodiments in which themouthpiece110 is covered except during usage, as is the case for theDPI disc inhaler100. In some embodiments, thecover125 may enclose themonitor200 except during usage, protecting it from accidental contact with the capacitance sensor. Additionally or alternatively, amonitor200 may include a color sensor that can validate usage by confirming the sensor recorded a color hue combination that is representative of a user's mouth or face. This color may be adapted to a particular user's color hue, thus eliminating false positives for third parties that may use the device or when theinhaler100 comes into contact with colors or areas of the body, such as the hands, that are not indicative of usage.
• Also, a distance or proximity sensor located on themonitor200 may determine whether the patient's mouth or face approaches themouthpiece110. The proximity sensor can be aimed outward from themouthpiece110 and determine whether an object came close an inhaler after recording motion. Additionally, a proximity sensor may be utilized in conjunction with atemperature sensor225 to confirm an object (i.e., the mouth) came within close proximity to themouthpiece110 during the requisite temperature changes. A proximity sensor may be any suitable proximity sensor including a laser, infrared, and an active sensor including sonar or active sensing lasers, or others.
• In some embodiments, amonitor200 may also validate usage in place of thetemperature validation step540 or themotion sensing step520, by monitoring the sound for characteristics indicative of usage. For example, thetemperature validation step540 may be replaced or supplemented by monitoring the sound, for example by listening for sounds indicative of a strong inhalation typical ofinhaler100 use. Additionally, theaudio sensor215 may listen for sounds indicative that the inhaler is actuated or being primed for actuation. For example, theMDI inhaler100 may emit a distinct sound during actuation and spraying of the aerosol. Additionally or alternatively, theDPI inhaler100 may emit distinct clicking sounds when thecover125 is rotated to uncover themain body140 or thelever130 is actuated into place. Additionally or alternatively, a compressor or other motive element of anebulizer inhaler100 likely will have a loud and distinct sound that may be monitored by amonitor200.
• Other factors other than temperature can be utilized to validate usage. For example, a distance or proximity sensor located on themonitor200 may determine whether the patient's mouth or face approaches themouthpiece110. The proximity sensor can be aimed outward from themouthpiece110 and determine whether an object came close an inhaler after recording motion. Additionally, a proximity sensor may be utilized in conjunction with atemperature sensor225 to confirm an object (i.e., the mouth) came within close proximity to themouthpiece110 during the requisite temperature changes. A proximity sensor may be any suitable proximity sensor including a laser, infrared, and an active sensor including sonar or active sensing lasers, or others.
• In some embodiments, amonitor200 on thenebulizer inhaler100 may be attached to themouthpiece110, and implement a two-step validation process. This process may include monitoring audio data for sounds indicating the compressor or motive element is operational andsensing temperature530 or other changes indicative that the patient's mouth is near themouthpiece110. In some embodiments, the audio validation may replace both thetemperature540 and motion validation steps520, or supplement them in various combinations to decrease the probability of false positives. For example, in the case of theMDI inhaler100, the audio monitor may detect the clicking indicative of priming theinhaler100 for use, and then detect the breathing sounds confirming usage has occurred.
• For each the environmental characteristics monitored mentioned above, they may be all monitored to increase the confidence of usage validation, or certain sub-combinations and sequences indicative of use may be utilized to validate usage. Accordingly, the embodiments described are only given as examples, and in no way intended to limit the various combinations that may be implemented by one of skill in the art to validate usage.
• For each type ofinhaler100, the environmental factors or process for evaluating monitored data to confirm usage may vary based on the type ofinhaler100 or may be the same. Additionally, these techniques may be applied to other types ofinhalers100 not specifically disclosed herein. Below, some examples of the logic and algorithms implemented to confirm usage for each type ofmonitor200 are disclosed.
Monitoring Compliance—MDI Inhaler Examples
• For proper usage, anMDI inhaler100 may require a user to shake theinhaler100, bring theinhaler100 to a patient's mouth, depress theinhaler100 to actuate, and breathe in the aerosolized medication. Therefore, these steps prescribed for proper use may be used to validate usage based on the methods described above.
• For example, once a patient picks up theMDI inhaler500, themonitor200 may wake up and begin to monitor motion for movements indicative of use. The motion a patient is instructed to perform is generally a shaking motion, wherein theMDI inhaler100 is moved back and forth in generally the same axis or nearly the same axis. Themotion sensor210 may monitor this motion and output data to be analyzed by acontroller235 to determine whether the motion recorded is indicative ofuse520.
• Many different algorithms may be implemented for determining whether the shaking motion prescribed for use of anMDI inhaler100 has occurred. For example, the shaking motion will generally occur along one axis, and various components of the motion may be analyzed to confirm this. In some embodiments, an accelerometer (or magnetometer or gyroscope) may monitor motion data for sudden changes in acceleration that occur in a positive, negative, positive sequence in substantially the same axis or plane. In some embodiments, an acceleration switch oriented in the axis of motion may be utilized to determine acceleration that crosses a certain threshold.
• Additionally, the shaking motion of anMDI inhaler100 generally will reach a threshold velocity and acceleration. For example, testing has revealed that typical shaking motion generally reaches an acceleration that is 1-2 times the acceleration of gravity. Therefore, the processing of motion data to determine whether it indicatesuse520 may incorporate a threshold filter. In some embodiments, this threshold may be equal to the acceleration of gravity, 0.5 times the acceleration of gravity, 0.3 times the acceleration of gravity or other suitable thresholds. Applying a threshold hold filter will likely eliminate false positives due to theinhaler100 experiencing small accelerations during normal activities the patient may engage in while carrying aninhaler100. Additionally, an acceleration switch or a plurality of acceleration switches may be used a low cost and low power consumption option to determine if and when acceleration in certain axes crosses a certain threshold. These could be used to look for a certain pattern in detecting acceleration above a threshold, for example, in the same axis but in a negative, positive, negative sequence.
• The shaking motion recorded by amonitor200 for anMDI inhaler100 may also exhibit certain frequencies not achieved by other common activities a patient may engage in. Testing has revealed that the shaking motion generally reaches a frequency 3-6 Hz. Accordingly, a frequency filter or other devices or techniques known in the art for evaluating the frequency of the motion may be implemented to determine whether motion indicative of use has been detected520. This may include a notch or band-pass filter. This frequency band may be 3-6 Hz, 2-7 Hz, 4-7 Hz, or other suitable frequency bands. In other embodiments, the frequency filter may only filter out frequencies lower than a threshold frequency of 2, 3 or 4 Hz, or other suitable thresholds.
• Additionally, the step of determining whether the motion indicatesuse520 may record the length of time for which the inhaler experience a certain magnitude, frequency or acceleration. Accordingly, if a frequency pattern is experienced for a length of time that is longer than a patient would typically shake an inhaler, the monitor may determine that no use should be recorded525. This period of time may be a few seconds, or up to thirty seconds or a minute, or other suitable time periods.
• Each of these above-mentioned features of the motion that may be monitored can be utilized in the step for determining whether the motion indicatesuse520 alone or in various combinations. For example, a band pass frequency filter may be utilized to first detect motion of a certain frequency, followed by a filter that determines whether the frequency reaches a minimum magnitude. Additionally, the analysis step may determine whether the acceleration occurs in the back and forth positive and negative pattern for a certain number of iterations. This will likely eliminate false positives from activities such as running, riding in vehicles, or other activities that have significant but sustained acceleration patterns.
• After the motion is monitored and analyzed, various other characteristics ofMDI inhaler100 usage may be monitored to confirm usage. For example, the temperature of thecartridge105 of theMDI inhaler100 may be monitored530 to determine whether the cartridge has been actuated540. In some embodiments, themonitor200 may monitor theambient temperature535 as well, and compare the ambient temperature to thecartridge105 temperature to validateusage540. The temperature of thecartridge105 may be monitored with any suitable temperature monitor, including a probe, thermistor, infra-red monitor, or any other suitable monitor.
• In another example, themonitor200 may monitor the temperature in close proximity to themouthpiece110 to determine whether an increase in temperature characteristic of an open mouth is detected. For example, themonitor200 may monitor the infra-red signature530 directly in front of themouthpiece110. This method can be advantageous because a patient typically is not instructed to touch their mouth to themouthpiece110 to avoid contamination and bacteria growth. Therefore, the infra-red temperature sensor225 may be aimed in a position for detecting an open mouth in the location the mouth would likely occupy during usage. The monitor fortemperature530 may also determine the length of time that the temperature increases. A temperature increase that persists for longer than a few seconds may likely indicate that usage has not occurred, and that theinhaler100 has been moved to a warmer environment. In some embodiments, themonitor200 may also monitor theambient temperature535 and compare the two readings and only confirm usage when the infra-red ormouthpiece110 temperature has risen with respect to the detectedambient temperature535. Accordingly, this can help eliminate false positives that may occur by theinhaler100 being relocated to an environment with a warmer temperature.
Monitoring Compliance—DPI Inhaler Examples
• In another example, aDPI inhaler100 may require the user to hold the inhaler level with respect to the ground, push on thethumb pad135 to reveal thelever130 andmouthpiece110. Next, the patient typically must slide thelever130 to prepare the powdered dosage for inhaling, bring theinhaler mouthpiece110 to the patient's mouth, and deeply inhale the prescribed dosage. Therefore, these steps prescribed for proper use may be utilized to validate usage based on the methods described above.
• For example, once themonitor200 wakes up510, themonitor200 may evaluate themotion520 to determine whether theinhaler100 is level or horizontal relative to gravity. A skilled artisan may implement a multitude of algorithms to perform this function. For example, amotion sensor210 may output the orientation of themonitor200 and accordingly, theinhaler100. Therefore, the motion data may be analyzed to determine whether theinhaler100 is picked up and held between certain angles with respect to gravity. A skilled artisan may design the monitor to sense when the angle is within plus orminus 3, 4, 5, 10, 15, 20, 30 or even 40 degrees deviation from being level or horizontal with respect to gravity. The algorithm may also determine whether the device is held within that range for a specific time interval, for example, 3, 5, 7, 10 seconds or other time periods. Additionally, an algorithm may also distinguish between themonitor200 resting on a flat surface in a building or outside (not moving in a vehicle) by determining no use should be recorded525 when the acceleration is virtually non-existent. Accordingly, when a patient is holding an inhaler still, the patient will not be able to keep theinhaler100 absolutely still and themonitor200 will be able to distinguish between these two situations. However, confirming theinhaler100 is held level for a predetermined period of time may allow for a significant number of false positives, and therefore additional environmental characteristic confirmation may be included.
• In some cases, patients are instructed to holdDPI inhalers100 initially vertically during actuation of thelever130 and then rotate the inhaler90 degrees towards the mouth to inhale. In this case, the motion evaluation algorithm may be based on determining if theinhaler100 is held vertically for a threshold window of time, and then rotated through a certain degree range towards a horizontal orientation. Additionally, an algorithm may evaluate themotion sensor210 output data for other characteristics of this motion including angular acceleration.
• Thecontroller235 and associated modules or other associated processors and software may evaluate themotion sensor210 output data to determine whether a movement signature of sliding themain body140 by pressing theMDI thumb pad135 is detected. Next, themotion sensor210 can process the signal to determine whether the signature of the sliding thelever130 is detected. Both of these motions may have similar signatures.
• In some embodiments, themonitor200 may be clipped into thelever130 in order to sense when thelever130 is being moved. The characteristics of the relevant movement in this example can be a short acceleration followed by an abrupt acceleration in the opposite direction once thelever130 clicks to a stop. Additionally, after thelever130 is actuated a patient typically brings the DPI inhaler towards the mouth to inhale the medication. Thesensor200 may accordingly sense the acceleration followed by deceleration associated with this motion, according to certain time constraints. For example, an algorithm may analyze motion data output from themotion sensor210 to determine if an acceleration and deceleration within the same axis, or substantially the same axis, is experienced within a time window. The time window may be a few seconds or more, or may not be required at all.
• Next, after sensing a motion or combination of motions that indicate usage is likely,520, themonitor200 may begin to monitor other characteristics to confirm usage. For instance, amonitor200 connected to aDPI inhaler100 may sense a temperature in close proximity to themouthpiece110 of theMDI inhaler530. In some embodiments, this may include an infra-red sensor226 that monitors for changes in temperature that are indicative of an open mouth near themouthpiece110. The algorithm and logic for monitoring the oral temperature changes may be analogous to those described herein and for theMDI inhaler100.
• As described above, additional environmental characteristics may be sensed in order to confirm that usage has occurred. For example, if amonitor200 is placed on themain body140 of theDPI inhaler100, a light monitor may detect when themain body140 has been rotated to reveal themouthpiece110,lever130 and monitor200. The light sensor and associatedcontroller235 may use a simple algorithm that detects a threshold level of light indicative of removing thecover125.
• Additionally, amonitor200 may monitor ambient sound to detect certain events surrounding usage of aDPI inhaler100. For example, a patient's sliding of thecover125 using thethumb pad135 and actuation with thelever130 create audible short clicks. Therefore, once themonitor200 is awake due to movement, the light monitor, or other wake up events, it may monitor ambient sound to determine whether a click is detected. In some embodiments, the analog sound detected may be converted to digital data by an analog-to-digital converter. Next, the audio data may be filtered for noise, by removing unwanted frequencies by methods discussed herein in connection with motion processing. Additionally, the filtered audio data may be analyzed to determine whether it is indicative of the clicking noises associating with preparing theDPI inhaler100 for usage. As these are examples only, additional environmental characteristics may be monitored for confirming usage including those discussed herein.
Monitoring Compliance—Nebulizer Inhaler Examples
• To properly operate anebulizer inhaler100, a patient may perform a specific series of actions that have qualities detectable by amonitor200. For example, a patient may fill a reservoir with medication, turn on the powered element (e.g., compressor, piezoelectric), and put on the mask or put themouthpiece110 near or into the patient's mouth. Next, the patient may breathe in the medication aerosol formed by the electronic motive element. Therefore, these steps prescribed for proper use may be utilized to validate usage based on the methods described above.
• In some embodiments, the patient's picking up the mask ormouthpiece110 associated with thenebulizer inhaler100 may wake up510 themonitor200. Next, amonitor200 may begin to monitor themotion515 withmotion sensor210. Thecontroller235 may then evaluate the motion data output from themotion sensor210 using algorithms to determine whether the detected motion data indicates usage has occurred. For example, the motion created by the compressor or piezoelectric component associated with thenebulizer inhaler100 may have a distinct and periodic vibration. For example, the vibration motion may have a frequency that far exceeds other motion experienced by themonitor200. Additionally, as discussed herein, other algorithms may be applied to the motion data that apply threshold magnitudes for the vibration detected to eliminate other vibration from motors or other devices that may be further away from the compressor.
• Additionally, in some embodiments, once the device wakes up510, it may establish a baseline data level, and then monitor the motion data to determine whether a sudden new frequency component is introduced. That way, if the inhaler ornebulizer100 is being used in a hospital environment, which likely contains a plethora of other devices surrounding a patient, the noise will be used as a baseline before the compressor is switched on. Furthermore, the monitor200 (or a related system) may also require the vibration from the motor of the compressor for a predetermined period of time before registering usage.
• Next, if themonitor200 determines that the detected motion indicates usage is likely, for example, by sensing the compressor is switched on, themonitor200 may evaluate additional characteristics to confirm usage. Additional confirmation may help prevent false positives potentially created by a patient switching on a compressor but not breathing in the medication, or a neighboring patient switching on adifferent nebulizer inhaler100. One additional characteristic that may be monitored is temperature changes that are indicative that a patient has applied their mouth to themouthpiece110 or mask.
• Themonitor200controller235 may then activate the various temperature monitors that may be incorporated with themonitor200. For example, themonitor200 may activate theambient temperature monitor535, and theoral temperature sensor225. Thecontroller235 may evaluate the data output from these sensors to determine whether the difference indicates a patient's mouth has been placed near themouthpiece110. For example, an infra-red monitor225 may be positioned near themouthpiece110 and aimed in a position to detect an open mouth.
• If the temperature change is recorded that indicates use is likely540, then themonitor200 may record theusage545 as discussed herein. Additional factors may be monitor instead of or in addition to those described herein to confirm a patient has used anebulizer inhaler100. For example, the electromagnetism created by the compressor may be sensed. Additionally, themonitor200 may monitor sound to confirm usage. As discussed above, the compressor or piezoelectric may create distinctive motion and sound waves detectable by anaudio sensor215 connected to amonitor200. These may be analyzed through audio analysis techniques known in the art and discussed herein. Additionally, these may be used in place of the motion sensing or as additional confirmation of usage.
• Also, monitor200controller235 may not require the motion and temperature to be detected in a sequence. For example, instead of a sequence, amonitor200 may only detect a combination of the motion and characteristic temperature change to indicate usage. Other combinations and sequences may also be utilized.
• Assisting a Patient with Compliance
• FIG. 13 illustrates an example of a process and method through which usage data received may be processed and implemented to assist a patient with asthma inhaler compliance and other advantages. This process may be implemented by anapplication300 or other module installed on amobile device100, aserver700, available over anetwork400, or others.FIG. 13 provides only an example of a method that may be implemented for assisting patient compliance, and therefore the available methods for assisting patient compliance should not be limited to those illustrated.
• In one example of a method for assisting a patient in managing compliance, once thesystem280 receives confirmation data that usage has occurred, thesystem280 may request that a patient confirm the type of inhaler used or other characteristics of the symptoms or usage. As discussed, inhalers medications are available in at least two different types: daily preventative anti-inflammatories, and rescue medications with bronchodilators (rescue medication are available in different dosages, including smaller dosage inhalers for patients in a situation where rescue is anticipated). If a patient has more than one medication type available, but utilizes the same monitor, thesystem280 may need to determine which inhaler has been utilized. For example, a notification may pop up on a patient's mobile device that asks whether the medication used was daily preventive or a rescue medication. Once patient responds and selects which medication has been utilized, that type of medication may then be associated with that usage data.
• In some embodiments, eachinhaler100 medication type will have itsown monitor200 and therefore, confirmation of the type of medication will be unnecessary.Inhalers100 may also include several different types of medication. For example, a 3-in-1inhaler100 may including a rescue, as needed, and scheduled medication as disclosed herein. In some embodiments, the inhaler may allow each of the medications to be rotated into place for actuation, or oriented with a certain medication being level or in a position for use by thepatient710. In some embodiments, the concepts discussed above with respect to motion sensing may be applied to determine which medication has been used by a patient.
• Thesystem280 may request a patient confirm other information associated with usage, including whether asthma symptoms decrease after medication, periodic questionnaires regarding symptoms, questions regarding severity of attack if rescue medication is used, and other data. Once the data is entered from the patient, or the usage data has been downloaded, thesystem280 may then store and analyze the data and compile the total number of uses. Thus, each uses is added to a total545 usage and further utilized to provide compliance assistance to a patient.
• For example, thesystem280 may include a dosage counter that monitors thecapacity625 indicating the number of remaining dosages left in thecartridge100 orinhaler100. For example, the total uses remaining for each type ofinhaler100 the patient owns may be recorded and output to adisplay260. Thedisplay260 may be as part of anapplication300 or accessible via a health care provider's servers, or on amonitor200. Additionally, thesystem280 may continually check to determine whether a refill is warranted645. The number of dosages in a particular type ofcartridge105 may be determined in advance by a health care provider, or may be calculated by experience with a particular inhaler for a particular patient. For example, thesystem280 may use an estimate of the number of dosages the first time a patient uses a particular type ofinhaler cartridge105. However, once the patient uses the new type of inhaler until empty, the usage data will allow thesystem280 to determine the number dosages that type of inhaler typically will include. This data may be modified over time with additional usage by the patient. The capacity of theinhaler100 may be displayed as a dosage number remaining, a capacity amount remaining, an estimated length of time until a refill is required and other suitable metrics.
• Thesystem280 may also send a notification to the patient through anapplication300, for example a pop-up notification on a mobile device, that the capacity is low. Additionally, the system may have an option for the patient to click and directly order arefill cartridge650 as discussed in detail herein. This notification may be sent when the capacity is at 15%, 30%, or a fixed number of uses. Additionally, depending on the anticipated or experienced lag time in replacement delivery, the notification may calculated to pop-up sufficiently in advance to allow delivery of a refill before the cartridge is anticipated to become empty.
• Thesystem280 may include processes for monitoring and assisting withcompliance630. These processes may include methods for notifying a patient when a daily dosage is due, for locating aninhaler100, for warning a patient they have entered a situation that may potentially trigger an asthma attack. For example, the system for monitoringcompliance630 may include a process for determining when the next dosage should be taken, based on a patient's dosage regimen and prior usage history. In some embodiments, this may include determining a time for anext use660 based on previous usage or determining fixed times during the day that the patient should be reminded to use the medication. If thesystem280 determines a new medication dosage should be taken, a notification is sent to thepatient670. This may be a notification on anapplication300, or an alert initiating on theinhaler100 or both.
• Thesystem280 may include a feedback system that assists a patient in timing of inhalation. For example, anMDI inhaler100 requires a certain timing of inhalation and exhalation to properly absorb the aerosolized medication. As patients are instructed to keep their mouth close but not covering themouthpiece110, once they actuate the MDI inhaler the aerosolized medication is released on a cloud outside themouthpiece110. At the right moment the patient must inhale the cloud of medication before it disperses. Additionally, a patient must hold the medication in its lungs for a set time period before exhaling again, or else the medication will not be properly absorbed.
• A feedback system may thus be implemented to assist a patient with the proper timing of inhalation and exhalation. For example, after a patient actuates theinhaler100, adisplay260, or other indicator may indicate to the patient the appropriate time to inhale, the appropriate amount of time to hold the medication in the patient's lungs, and the appropriate time to exhale. A color coded system could be used for such purpose. For example, a green light may indicate a patient should inhale the medication, a yellow light indicate the patient should hold, and a switch back to green may indicate the patient is free to exhale the medication. Any other color scheme, audio indications, or other indications may be used to provide the feedback. Additionally, the feedback may be provided by themonitor200, an application installed on an associatedmobile device150 or other associated device.
• The system for monitoring compliance may also include a locateinhaler function665. This process may be initiated in response to the system determining it is time for a patient's next use, or manually by the patient requesting the function be initiated through theapplication300 on theirmobile device150. The locateinhaler function665 may indicate the distance to theinhaler675 from amobile device150 running anapplication300 interfaced with themonitor200. This may be provided by warning the user when the mobile device is moving closer to or away from the patient. This may be done by the strength of the Bluetooth signal or by separate GPS devices on themonitor200 andmobile device150.
• The locateinhaler function665 may also send a notification to themonitor200 to flash a visual or initiate an audio alert685, or begin to vibrate. This will allow the user to identify the inhaler more easily identify and locate the inhaler.
Health Care Provider Information Network
• FIG. 14 is an overview of an example interface of the overall asthmacompliance assistance system280, in communication with a health care provider's information network. Anapplication300 on amobile device150 may have awireless250 or wired link to anetwork400 in order to be connected to the services of a health care provider utilizing anasthma compliance system280.Network400 is a broad term and may include, without limitation, the internet, virtual private networks, local area networks, wireless local area networks, wide area networks, metropolitan area networks, and personal area networks. The provider may have aserver700 that may be accessed over anetwork400 through a website or other appropriate interface by apatient710 or parents of apatient710, or by a doctor or otherhealth care providers715.
• Theserver700 may provide usage statistics, compliance information and other features discussed herein to thepatient710 orhealth care provider715. This will allow thepatient710, the patient's doctor, and others to evaluate the compliance and usage data to recommend modifications in dosages or provide feedback and encouragement regarding usage. Additionally,health insurance providers715 may also access the information to give rate discounts on premiums or other incentives to promote compliance by apatient710.
• The asthma compliance system provider may include servers that operate theprovider services710 and associated computers and software that execute features discussed herein and additional features. The provider services720 may be accessible overnetworks400 including the internet and may be in communication with a patient's710mobile device150. For instance, as information is collected from themonitor200 and uploaded to themobile device150, it may be uploaded to theprovider services720 systems and processed for further utilization. Additionally, notifications, new firmware, software, or other information may be sent directly from theprovider services720 systems to the patient'sapplication300 on theirmobile device150. Accordingly, notifications may then be sent wirelessly to the patient'smonitor200 connected to theasthma inhaler100, or new software or algorithms may be downloaded. These instructions may be for a new type ofinhaler100, for a change in patient treatment regimen, or for other appropriate situations.
• The provider network may include adatabase705 for storing information collected frommonitors200 fromvarious patients710 and from other sources including weather information, and manually entered data. This database may be accessed by provider services and also by thepatient710 through theserver700.
Cartridge Refill Provider
• FIG. 15 illustrates an example of the network connectivity between a patient and arefill cartridge supplier730 that allows a patient to purchase refills through theirmobile device150. Once thesystem280 determines a refill is needed645, that information may be sent to asupplier730 over anetwork400 through a variety of channels.
• FIG. 15 illustrates one example of such connectivity. A supplier'sAPI725 may be utilized to integrate the provider'sservices720 with the patient'sapplication300. Accordingly, thesupplier730 may be notified directly that a refill is required or purchased by integrating its purchasing, billing, and shipping information systems, with the patient'sapplication300. Accordingly, once the patient confirms he or she would like to purchase an additional refill, that information and confirmation may be sent back tosupplier730 through anAPI725. Thus, the transaction may be performed securely and conveniently without, human interaction on the provider side. In another embodiment, the notification may be sent tosupplier730, but the order filled manually by thesupplier730 once the data is received.
• FIG. 16 illustrates an example of a step-by-step sequence for ordering and sending a refill. First, anasthma compliance system280 may determine that a refill is required soon800. Next, a notification may be sent to a patient notifying them that a refill is required650. Thepatient710 may also optionally be presented with an option to directly purchase arefill805. The patient may confirm this and purchase therefill810 by accepting or clicking purchase on theirmobile device150 or other computer used to interact with thesystem280. Next, the purchase notification is sent to thesupplier API815, which translates the information into a purchase order or electronic request to purchase an inhaler refill. Then, the supplier's systems may confirm and process theorder820, and send it to thepatient825.
Neural Network for Predicting Asthma Symptoms
• FIG. 17 illustrates an example of aneural network915 implemented to augment the compliance andasthma management system280. Generally, theneural network915 may utilize data from manydifferent users900 of theasthma management system280, including their personal attributes and environment, and utilize that information to make predictions about triggers and treatments forindividual patients710. Thus, theneural network915 may assist in predicting the environmental factors that may trigger the onset of an asthmatic reaction in apatient710. Additionally, theneural network710 may be implemented to modify a patient's daily medication regimen to improve its efficacy or cost effectiveness.
• FIG. 17 illustrates one example of the connectivity of the system that may be utilized to implement aneural network915. A health care provider may provide anasthma compliance system280 as disclosed herein toseveral users900 or clients. Accordingly,usage data600, personal information, and medical histories related to thoseusers900 may be downloaded over anetwork400 aggregated and processed by the provider services720. Additionally, this data may be stored in thedatabase705. Thus, thesystem280 may aggregate large amounts of data, about the places, environments, and factors that trigger asthma attacks and the effect that certain dosage regimens have on specific patients.
• This data may be very useful as a predictive indicator for how like patients may respond to similar environments, treatment regimens, and what may trigger attacks inspecific patients710. Accordingly, the predictions may be sent to patients as warnings for attacks, as recommendations for doctors to evaluate and modify a treatment regimen, and as information as when apatient710 may take increased dosages of preventive medication.
• Below is an example of how a neural network may provide assistive information and notifications to apatient710. When a patient enrolls in anasthma compliance system280, they may fill out a personal questionnaire, or allow their personal information and medical history to be loaded into thedatabase705 via theprovider services720 or other sources. Additionally, over time, theusage data600 collected by thesystem280 may be aggregated by theprovider services720 and stored in thedatabase705. Additionally,other users900 may accumulateusage data600 and upload that information to theprovider services720 along with their personal information, medical histories, and genetic makeup.
• This information may be processed by aneural network915 that is in communication withprovider services720. Theneural network915 may determine patterns including factors for certain patients that produce asthma attacks based on location, weather, medical histories, altitude, and genetics. Additionally, theneural network915 may be able to determine patterns that indicate frequencies of attacks based on dosage regimes and other effects of dosage regimens on certain patients.
• Once theneural network915 has established these patterns and the model is created, theindividual patent710 usage data, personal medical history, and genetics may be processed by theneural network915. Accordingly, theneural network915 may be able to modify the dosage regimen of thepatient710 to determine an optimal dosage or formulation for a specific patient. Additionally, theneural network915 may be able to determine certain formulations with different by similar active ingredients that may provide the optimal treatment outcome.
• Additionally, the patient's environmental details can be continually fed into theneural network915 and theneural network915 may predict that there is a high likelihood that the patient's present environment may trigger an asthma attack. For example, a patient may be traveling to a new state, for example Nebraska. Once the patient arrives at the destination, the patient's cellphone may send location data to theapplication300 which is then transmitted over thenetwork400 to theprovider services720 and processed by theneural network915. Accordingly, theneural network915 may then determine that an asthma attack is likely because similar patients experienced such attacks in Nebraska (or under similar conditions to those now present in Nebraska, as determined by the neural network). Accordingly, theprovider services720 may send thealert notification910 data over the network related to the warning to be transmitted to theapplication300. Theapplication300 may then pop up an alert notification920 to thepatient710 that indicates thepatient710 should have the rescue medication ready or should take preventative medication.
• Additionally, theneural network915 may prepare reports that indicate high risk factors for aspecific patient710. Thepatient710 may access the reports through theapplication300 on his or hermobile device150 or remotely over anetwork400 through accessing a website interface for theserver700. The report may include problematic areas of the country or world that may trigger attacks.
Compliance Monitor Design—Universal Insert for Inhalers
• FIGS. 15-16 illustrate examples of auniversal monitor200 that is configured to be removably connectable to a variety ofinhalers100. Theuniversal monitor200 may be any shape or configuration that may be connected to asensor200 housing. For example, theuniversal monitor200 may be a small cylindrical or square shape that is configured to attach to a space, or opening in amonitor200 housing.FIG. 18 illustrates an example of a monitor housing designed for anMDI inhaler100 that is configured to be connectable to auniversal monitor200.FIG. 19 illustrates a similar embodiment for aDPI inhaler100. As shown by the dashed arrows between thesensors200 and theinhalers100 ofFIGS. 18 and 19, in some embodiments, theuniversal monitor200 may plug into, or snap on the outside of amonitor200 housing. Theuniversal monitor200 may connect to themonitor200 housing by any other suitable means. Theuniversal monitor200 may contain the majority or all of the electronic components of the part of themonitoring system280 that is physically connected to theinhaler100. In other embodiments, theuniversal monitor200 may contain a portion of the electronic components.
• Accordingly, theuniversal monitor200 may be removed from oneinhaler100 and applied to another inhaler type (e.g., MDI to DPI). Additionally, a manufacturer will be able to fabricate a singleuniversal monitor200 for the variety of sensor types, eliminating inefficiencies created by requiring the process, boards, or other components to be separately incorporated into each type ofhousing110 for each type ofinhaler100.
Multiple Criteria, Sensor Verification
• FIG. 20 illustrates schematically how one or more sensors can confirm1208 that one or more criteria (1201,1203,1205) have been completed1207. For example, a system may have a goal of completing1207 a series of criteria (1201,1203,1205) in sequence or in parallel. These criteria can be physical acts or otherwise measurable events. Sensors (1202,1204,1206) can be designed, configured, positioned, etc. to measure or record (1212,1223,1225,1243,1245,1265) the criteria or byproducts related to the criteria. An elegant system can use a single sensor to confirm more than one criterion. For example, sensor1 (1202) may be used to confirm criterion1 (1201), as indicated byarrow1212, to confirm criterion2 (1203) as indicated byarrow1223, and to confirm criterion3 (1205), as indicated byarrow1225. Such elegance can be highly desirable because it may save on manufacturing and/or operating costs.
• However, in some cases, multiple sensors may be useful. For example, the criteria may be so different that very different sensors are required to measure them. In some cases, a cheap sensor may be less expensive or more energy efficient to operate, while a high resolution sensor may be able to gather data more effectively or more rapidly. In this case, it may ultimately be more advantageous to trade physical elegance for energy efficiency, because two sensors together can be more efficient than a single sensor.
• Some particularly useful embodiments of a monitor system incorporate three sensors that can obtain data independently but work together in the system. A first sensor can be a simple mechanical sensor, also referred to as a switch, which can have very low power consumption. This first sensor can be relatively simple compared to other sensors by having fewer axes or dimensions that are sensitive to motion, by requiring a threshold magnitude of motion before switching on, etc. Such a sensor can act as a system switch to turn a controller, processor, and/or other sensors on and off, thereby saving energy. A second sensor can be more sensitive and/or allow more types of data to be collected, although it may also have greater power consumption as a result of its additional capabilities. An example of a second sensor is a digital AGM sensor, such as those used in the aerospace industry. The second sensor can measure the frequency of a shaking motion of an inhaler with sufficient accuracy to process the data and recognize a signature motion as described above. The third sensor can be a directional infrared sensor, for example. This third sensor can have its directional axis aligned with the opening of an inhaler that is configured to pass inhalants into the mouth of a user. Thus, the sensor can take temperature data indicating or confirming when the inhaler is positioned to provide a dose into the mouth of a user. Thus, in some three-sensor monitoring systems, a first sensor plays the role of an initialization/power-saving switch, a second sensor plays the role of high resolution motion sensor, and a third sensor plays the role of confirming sensor. The third sensor can be particularly helpful in its confirmation role if the data it takes is distinct from the data from the second sensor. Thus, a temperature sensor aimed at the place where a mouth would be can be particularly helpful in confirming that a willful, pre-dosing shake has occurred and the user has indeed intended to perform the full dosing motions.
• Another example of a series of criteria can be provided in the context of a disk inhaler the disk inhaler and cover described above (see, e.g.,FIG. 4A,FIG. 4B, and/orFIG. 4H). The criteria can comprise one or more of the following: (1) Open—opening the device, exposing the mouthpiece and the lever; (2) Click—pulling the lever back, dispensing the medication into the mouthpiece; (3) Inhale—placing the device on the user's lips and inhaling the medication; (4) Close—closing the device and storing it in a dry place. Medication from a DPI is often taken twice a day, once every twelve hours. The above four criteria can, for example, be confirmed using one or more sensors. One or more rotation sensors can be used to confirm criteria (1), (2), and/or (4); an accelerometer can be used to confirm criteria (1), (2), and/or (4); a sound sensor can be used to confirm criteria (1), (2), (3), and/or (4); a light sensor can be used to confirm criteria (1), (3), and/or (4); a temperature sensor can be used to confirm criterion (3), as well as the presence of a hand that may be engaged in criteria (1)-(4); etc.
• A nebulizer (see, e.g.,FIG. 2E) can have a distinctive sound or motion when it is turned on. Steps involved in using a nebulizer can include: (A) open the cup (see, e.g.,FIG. 2C) and place the medication inside, then close the cup; (B) connect thetubing112 into the nebulizer and attach themouthpiece110; (C) turn the nebulizer on; (D) hold themouthpiece110 to the user's mouth and have user breathe in using the mouth, continuing to breathe in this manner until no medication remains. Nebulizers are often prescribed for use only during an asthma attack. A sensor or sensor system can be attached to the body of a nebulizer to more readily detect distinctive vibrations. Nebulizers that produce a distinctive humming or buzzing sound can employ a sound sensor (e.g., a microphone) to detect when they are in use to help monitor use.
Detection of MDI Inhaler Use
• As noted above, a criterion for verifying that an MDI inhaler has been used, for example, is for the user to shake the inhaler. Typically, the prescribed shaking motion will be distinctive relative to other motions made during most activity. Experiments were performed to verify this. The approach was to list expected motions for an inhaler to experience and then comparing the acceleration data for these motions compared to the shaking motion. By verifying the uniqueness of the shaking motion, the validity of the method of using an accelerometer to detect the use of an inhaler can be proven. Uncertainties in results from a single sensor can be overcome by using other sensors (e.g., temperature measurement, magnetometer and gyroscope measurement, etc.)
• Motions tested included the following: prescribed inhaler shaking; walking; running; jumping; driving; biking; tossing the sensor. Positions for the sensor during testing included the following: hand, pocket, keychain, bag, purse, backpack, loose.
• FIG. 21A shows data taken when an accelerometer is shaken in the way that an inhaler would be shaken before use—that is, the prescribed shaking motion. The vertical axis on the graph is the acceleration in gravities. Acceleration in gravities (gs) is plotted versus time. The accelerometer has the ability to measure up to 2 gravities, which is close to the maximum value of what it records during this motion. There is a regular back and forth motion that can be observed on all three axes, though the most dramatic motion appears to be on the y-axis of the accelerometer (green) because this is the axis that corresponds to the up and down motion of the accelerometer.
• FIG. 21B shows data from a longer period of time that includes the time depicted inFIG. 21A, as shown. It also shows two othersubsequent time periods2120 during which prescribed shaking occurred. This data indicates that the prescribed shaking motion does indeed result in a distinctive data pattern, and that this pattern can be defined or otherwise recognized as a signature motion for the purposes discussed herein.
• FIG. 21C shows data gathered during a short sprint of only a few steps, with the accelerometer being held in a pocket. In some respects, this data has a similar shape to the shaking data ofFIG. 21A. However, the x-axis appears to have more regular motion and distinctive peaks. Thus, if a user is instructed to shake an inhaler while orienting the inhaler in a particular way, this type of axis selection can be used to identify signature motions. But this may not be necessary based on this data, because the magnitude of the x-axis peaks (approximately 3 gs peak to trough) is less than that of the signature motion (often closer to 3.5 gs peak to trough) illustrated inFIG. 21A andFIG. 21B. Moreover, the frequency of the data is different, with the running oscillation having about half the frequency of the prescribed shaking oscillation. This seems to be consistent because it typically takes longer for a runner's legs to stride forward between steps that strike the ground than it does for a user's arm to shake rapidly back and forth in the air.
• FIG. 21D shows data gathered during a short sprint of only a few steps, with the accelerometer being held in a hand. This data has an even larger movement, possibly even enough to rule it out as too large to be a prescribed shaking motion. This movement appears to have exceeded the accelerometer's maximum abilities, since the data is clipped at the top and bottom extremes. Also the frequency is lower than the prescribed shaking shown inFIG. 21A, for example. This data inFIG. 21D appears to be the closest to the prescribed shaking ofFIG. 21A; the fact that even this data can be distinguished validates the hypothesis that an accelerometer of this type may be sufficient for the monitoring and verifying as described herein.
• FIG. 21E shows acceleration data for walking while holding the accelerometer in a pocket. Both magnitude and frequency of the motion appears to be less than for the prescribed shaking motion ofFIG. 21A.
• FIG. 21F shows data for tossing the accelerometer into the air and catching it repeatedly. The patterns shown in this data are quite distinct fromFIG. 21A. The frequency (e.g., distance as measured in the x-axis dimension from peak to peak) is much lower, for example.
• The following table shows some of the numerical values for data from the tests and examples described above:

• 					Positive Magnitudes
  	Event	Duration	Crests or		(gravities or gs)	Frequency
  Event Type	Number	(sec)	Peaks	Troughs	min-max	(Hz)

  Shaking:	1	2	9	10	1-1.9	4.5
  	2	2.6	9	9	1.6-2	3.46
  	3	2	10	10	1.3-2	5
  	4	2	7	6	1.9-2	3.5
  	5	3	12	13	1.8-2	4
  	6	2	7	6	1.8-2	3.5
  	7	2.5	15	14	0.6-2	6
  	8	2	12	14	0.8-2	6
  	9	2	13	12	0.8-1.9	6.5
  	10	0.8	4	4	1.3-1.7	5
  Running	1	3.5	9	8	−0.2-0.9	2.57
  (pocket):	2	3.5	9	10	0.3-0.9	2.57
  Running	1	4	10	9	0.9-1.9	2.5
  (hand):	2	4	10	9	1.7-2	2.5
  Bike Ride	1	5	5	4	0.1-0.2	1
  (pocket):

• As indicated by the above data, the prescribed shaking motions have a higher frequency (3.5-6.5) than the other motions (1-2.57). Prescribed shaking motions also have a high magnitude, but this is not quite as unique as frequency. This data tends to validate the hypothesis as described above.
• A detection algorithm can use the above findings. For example, a signal can be analyzed or processed to identify feature such as those shown inFIG. 21A, including both the shape of a single shaking event and the presence of multiple such events. Based on this data, frequency is perhaps more valuable than magnitude for identifying signature motions.
Detection of Disk Inhaler Use
• A criterion for verifying that a disk inhaler has been used, for example, is for the user to bring it to his or her mouth. Experiments were performed to discover if these motions are indeed measurably distinct. It was assumed that the data from picking up and putting down the accelerometer would not be distinct—instead, the motion of bringing the inhaler laterally toward and away from the mouth was a focus of the experiments.
• FIGS. 22A and 22B include data from picking up a DPI and moving it laterally toward the mouth of a user. These data show a distinct pattern. Acceleration in gravities (gs) is plotted versus time. The data for the accelerometer's x-axis is a bit noisy until the user begins to take the medication at approximately 600 in time inFIG. 22A, and at approximately 950 in time inFIG. 22B.
• FIG. 22C shows a user bringing the device up to their mouth and moving it away multiple times. The pattern that was detected above inFIG. 22A andFIG. 22B is still evident in this data capture. After passing this data through a simple low pass filter the noise can be filtered out and the pattern more easily detectable.
• FIG. 22D shows data recorded during a longer process: that is, having the inhaler laying down, picking it up, moving it towards the mouth, breathing, moving it away and then putting it down. Once again the pattern is recognizable and can be detected even with the noise in the system. Accordingly, the approach appears to be validated by this data.
• A detection algorithm can use the above findings. For example, a signal can be analyzed or processed to identify features (e.g., signature movements) such as those shown inFIG. 22A-D. The magnitude may vary with the respect to the speed the user brings the device to their mouth but an absolute magnitude can be determined, which may improve accuracy. The duration of the crest (corresponding to the duration the user is inhaling) can also be determined to filter out false positives. If the period is too short or too long then the data can be discarded. This motion may not be sufficient to verify that the user has taken their medication so data from other sensors in conjunction with this one may be helpful to register it as a confirmed dispensing of a dose.
• With respect toFIG. 23,FIG. 4F-FIG.4I above show an example of monitor for a DPI inhaler that can include a rotating cover for the inhaler. The cover can be rotated to open it and grant a user access to the mouthpiece to administer a medication dose. One or more rotation (or gyroscopic) sensors can be employed to detect this rotating motion.FIG. 23 shows validation data from a gyroscopic sensor in this context. Some gyroscopic sensors have multiple sensors, aligned with orthogonal (or otherwise non-aligned) physical axes. In this example, data from three orthogonal gyroscopic sensors is provided. The strong periodic pattern visible in the data from one sensor is not only distinctive (and therefore a good candidate for a signature motion that can be used to verify inhaler deployment), it is also distinct from the data from the other sensor(s). Thus, multiple sensors and/or multiple orientations for independent sensors can be used to avoid false positives and provide more reliable data.
Temperature Sensor Verification of Inhaler Use—Mouth Temperature
• As noted above, directional temperature detectors can be used to verify use of an inhaler because a human's internal (e.g., mouth) temperature is relatively high and relatively consistent. Measuring the temperature of a skin surface such as a cheek can also be useful for verification purposes, although in some cases an internal temperature is more constant, particularly in warm-blooded mammals. The figures described below show temperature on the vertical axis and time on the horizontal axis. In each case, the data in the upper graph (FIG. 24A,FIG. 24C,FIG. 24E, etc.) is raw and the data in the lower graph (FIG. 24B,FIG. 24D,FIG. 24F, etc.) results from applying a filter (e.g., a low-pass filter) to the raw data. For example, the low-pass filter can be a frequency-domain filter that helps smooth frequency jitter or other noise effects in the data. The low-pass filter in some cases may be applied in other domains such as the time domain. The data was collected using a CC2541 SensorTag device from Texas Instruments.
• FIGS. 24A-24B show the difference between a temperature reading from a directional temperature sensor aimed first into an air-conditioned room (ambient), then aimed at the surface skin on a human cheek (data feature roughly centered on100), then back into ambient air. This same sequence was repeated, as can be seen in the data of the two figures. The face temperature is clearly warmer than the ambient temperature, and the response of the temperature sensor appears to be relatively rapid and distinct. This data appears to validate that such a sensor can be used for the goals discussed herein—e.g., to help a monitor system determine when an inhaler has been positioned near or aimed toward a cheek of a user, and to track the length of time that position and/or orientation has been maintained.
• FIGS. 24C-24D show temperature data from four human exhale-inhale events (withFIG. 24C showing the raw data andFIG. 24D showing the data after a low-pass filter has been applied). As can be seen, the temperature change is extreme, and easy to detect. Incidentally, the device seems to be strongly affected by the condensation and evaporation of water from breathing. This can be helpful because a very clear indication of human breath can make the monitoring or verification functions more robust. On the other hand, some sensors may be sensitive to water vapor and the environment may cause them to degrade more rapidly. Accordingly, it can be helpful to encase or otherwise protect temperature sensors to allow them to last a longer time, despite being subject periodically to warm and humid conditions associated with proximity to human breathing.
• Because some embodiments may include a waterproof container or cover for a temperature sensor,FIG. 24E andFIG. 24F show data that was taken using the clear plastic cover provided with the SensorTag. LikeFIG. 24C andFIG. 24D, these also show four human exhale-inhale events. The temperature change doesn't seem to be nearly as significant in the later breaths. Potentially this is because the cover stored and retained heat energy from the earlier breaths, so that it was unable to cool as rapidly as the temperature sensor alone. Other covers having less mass or having different heat retention and heat conductivity could be used to mitigate or eliminate this effect.
• FIG. 24G andFIG. 24H show data taken with a piece of plastic over the sensor to roughly simulate how it would work in a water-tight container. This data shows distinct breathing events, but with lower magnitude and less distinct profiles than those signatures depicted inFIG. 24A andFIG. 24B. However, the events are nevertheless distinguishable based on the data provided here, further validating the approach described herein. Different angles seem to affect the effectiveness of the sensor as well, as is expected from temperature sensors for which a sensitive directional axis is indicated.
• FIG. 24I andFIG. 24J show data from further testing, which indicate very distinct temperature changes. For this data, the sensor was positioned at various distances from the target. In particular, the sensor was brought progressively closer to the mouth, followed by several breaths performed in front of the sensor. Between breaths the sensor is away from the face. The sensor has a wide field of view and averages the temperatures over its entire field of view for the final value, so the closer the sensor is to what it is measuring the more that target's temperature affects the overall sensor output. The relevant distances from the target—e.g., on or associated with an inhaler housing, given standard inhaler sizes—appear to provide satisfactory results. As indicated in these figures, there is a significant rise and fall in temperature when an exhale-inhale event occurs. This further validates the use of a sensor for the methods described herein.
• From the series of data shown above inFIG. 24A toFIG. 24J, it appears that using an infrared temperature gauge to detect the use of an inhaler by pointing it into the mouth is validated. Because the act of inhaling and exhaling, something necessary for the process of using an inhaler, creates a fairly distinctive change in the temperature reading of the sensor it is possible to use an algorithm to detect the act. The temperature of the mouth varies much less than that of the skin, based on external factors, and the temperature of the mouth is higher than that of the skin in general, providing for a more distinctive value to detect. The fact that there is usually a drop after the breath also aids in the detection of the breath.
• Even if further data indicates smaller temperature differences between a human mouth and ambient air present on a very hot day or in a hot car, other facts can be considered. For example, an ambient air on a hot day or in a hot car is typically not as humid as the air in or exhaled from a human mouth. Thus, further sensors could be used to determine humidity, for example. Other sensors that measure optical effects such as mouth color or reflectivity of moist pink surfaces, etc. can also be used in place of or in addition to temperature and/or humidity sensors. If a sensor is capable of evaluating absolute temperature or absolute humidity (rather than simply relative temperature or relative humidity), that sensor, along with associated logic or a processor memory, can also evaluate whether its own data is reliable. For example, if a sensor and system are aware that ambient temperature and/or humidity are similar to that of a human mouth, they may alert a user of this factor, annotate the data to show how it should be evaluated, etc. Moreover, any difficulty in measuring temperature is mitigated by the fact that temperature is, in many of the systems described herein, filling the role of a secondary validation or confirmation of inhaler use, rather than as a primary indicator.
Temperature Sensor Verification of Inhaler Use—Pressurized Container
• As noted above, the change in pressure involved as some pressurized inhaler containers are discharged can also lead to temperature changes that can be tracked or sensed with temperature sensors. MDI inhalers include pressurized cartridges that a patient actuates by pressing down and breathing in while the medication is sprayed out of a nozzle. During dispensing, the pressure of the contents decreases as it enters the atmosphere. Due to Gay-Lussac's law (P₁/T₁=P₂/T₂), the temperature of the canister also drops when the pressure decreases, causing a noticeable drop in temperature of the cartridge for each actuation of the MDI relative to the atmosphere.
• Based on this physical theory, data was taken to validate how a temperature sensor could be used to measure this phenomenon in order to confirm inhaler use and/or dispensation of medication from a pressurized container. Initial testing was inconclusive, but identified several variables to adjust and/or improve sensor and system design. A temperature sensor can be positioned where a user's finger pushes on a canister to cause emission of medication. Thus, assuming a user's finger is different from the ambient temperature and a glove is not being worn, etc., this can be an alternative manner of confirming inhaler use that does not rely on the pressure and temperature effect described above. Temperature sensors that are not too sensitive to shaking are preferred, because inhaler shaking is prescribed and expected shortly before discharge of medication. Placement of a temperature sensor such that it contacts the wall of a medication container without too much interference from an insulating sticker, for example, is preferred. Metal medication canisters are common, but a sensor may advantageously employ an intermediary material that assists it in adhering to the edge of the canister and also transfers heat appropriately. Heat emissivity of the medication container and/or any intermediary materials can be designed or accounted for.
Scope of Disclosure
• Although this disclosure is made with reference to preferred and example embodiments, the systems and methods disclosed are not limited to the preferred embodiments only. Rather, a person of ordinary skill will recognize from the disclosure herein a wide number of alternatives. Unless indicated otherwise, it may be assumed that the process steps described herein are implemented within one or more modules, including logic embodied in hardware or firmware, or a collection of software instructions, possibly having entry and exit points, written in a programming language, such as, for example C++. A software module may be compiled and linked into an executable program, installed in a dynamic link library, or may be written in an interpretive language such as BASIC. It will be appreciated that software modules may be callable from other modules or from themselves, and/or may be invoked in response to detected events or interrupts. Software instructions may be embedded in firmware, such as an EPROM or EEPROM. It will be further appreciated that hardware modules may be comprised of connected logic units, such as gates and flip-flops, and/or may be comprised of programmable units, such as programmable gate arrays or processors. The modules described herein are preferably implemented as software modules, but may be represented in hardware or firmware. The software modules may be executed by one or more general purpose computers. The software modules may be stored on or within any suitable computer-readable medium. The data described herein may be stored in one or more suitable mediums, including but not limited to a computer-readable medium. The data described herein may be stored in one or more suitable formats, including but not limited to a data file, a database, an expert system, or the like.
• The various illustrative logical blocks, modules, and processes described herein may be implemented as electronic hardware, computer software, or combinations of both. To clearly illustrate this interchangeability of hardware and software, various illustrative components, blocks, modules, and states have been described above generally in terms of their functionality. However, while the various modules are illustrated separately, they may share some or all of the same underlying logic or code. Certain of the logical blocks, modules, and processes described herein may instead be implemented monolithically.
• The various illustrative logical blocks, modules, and processes described herein may be implemented or performed by a machine, such as a computer, a processor, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA) or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions described herein. A processor may be a microprocessor, a controller, microcontroller, state machine, combinations of the same, or the like. A processor may also be implemented as a combination of computing devices, e.g., a combination of a DSP and a microprocessor, a plurality of microprocessors or processor cores, one or more graphics or stream processors, one or more microprocessors in conjunction with a DSP, or any other such configuration.
• The blocks or states of the processes described herein may be embodied directly in hardware, in a software module executed by a processor, or in a combination of the two. For example, each of the processes described above may also be embodied in, and fully automated by, software modules executed by one or more machines such as computers or computer processors. A module may reside in a computer-readable storage medium such as RAM memory, flash memory, ROM memory, EPROM memory, EEPROM memory, registers, hard disk, a removable disk, a CD-ROM, memory capable of storing firmware, or any other form of computer-readable storage medium known in the art. An exemplary computer-readable storage medium can be coupled to a processor such that the processor can read information from, and write information to, the computer-readable storage medium. In the alternative, the computer-readable storage medium may be integral to the processor. The processor and the computer-readable storage medium may reside in an ASIC.
• Each computing device may be implemented using one or more physical computers, processors, embedded devices, field programmable gate arrays (FPGAs) or computer systems or a combination or portions thereof. The instructions executed by the computing device may also be read in from a computer-readable medium. The computer-readable medium may be a CD, DVD, optical or magnetic disk, flash memory, laserdisc, carrier wave, or any other medium that is readable by the computing device. In some embodiments, hardwired circuitry may be used in place of or in combination with software instructions executed by the processor. Communication among modules, systems, devices, and elements may be over a direct or switched connections, and wired or wireless networks or connections, via directly connected wires, or any other appropriate communication mechanism. Transmission of information may be performed on the hardware layer using any appropriate system, device, or protocol, including those related to or utilizing Firewire, PCI, PCI express, CardBus, USB, CAN, SCSI, IDA, RS232, RS422, RS485, 802.11, etc. The communication among modules, systems, devices, and elements may include handshaking, notifications, coordination, encapsulation, encryption, headers, such as routing or error detecting headers, or any other appropriate communication protocol or attribute. Communication may also messages related to HTTP, HTTPS, FTP, TCP, IP, ebMS OASIS/ebXML, DICOM, DICOS, secure sockets, VPN, encrypted or unencrypted pipes, MIME, SMTP, MIME Multipart/Related Content-type, SQL, etc.
• Depending on the embodiment, certain acts, events, or functions of any of the processes or algorithms described herein can be performed in a different sequence, may be added, merged, or left out altogether. Thus, in certain embodiments, not all described acts or events are necessary for the practice of the processes. Moreover, in certain embodiments, acts or events may be performed concurrently, e.g., through multi-threaded processing, interrupt processing, or via multiple processors or processor cores, rather than sequentially.
• Conditional language used herein, such as, among others, “can,” “could,” “might,” “may,” “e.g.,” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments may or may not include, certain features, elements, benefits, capabilities and/or states. Thus, such conditional language is not generally intended to imply that features, elements and/or states are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without author input or prompting, whether these features, elements and/or states are included or are to be performed in any particular embodiment.
• While the above detailed description has shown, described, and pointed out novel features as applied to various embodiments, it will be understood that various omissions, substitutions, and changes in the form and details of the logical blocks, modules, and processes illustrated may be made without departing from the spirit of the disclosure. As will be recognized, certain aspects of the disclosure described herein may be embodied within a form that does not provide all of the features and benefits set forth herein, as some features may be used or practiced separately from others.

Claims (20)

What is claimed is:

1. A monitor system for detecting usage of an inhaler, the monitor system comprising:

a compact housing configured to be removably connectable to an inhaler that is configured to enclose and deliver inhalable medication to a user;

a controller located within the housing;

an inhaler communication interface within the compact housing in electronic communication with the controller and configured to send and receive data;

a memory and a battery in electrical communication with the controller and contained within the housing;

a motion sensor in electrical communication with the controller that outputs data indicative of a motion of the housing, the motion sensor configured to be physically coupled to the inhaler such that it can detect signature motions of the inhaler and the enclosed medication, the signature motions comprising at least two movements of the inhaler occurring within a first time window of one another and indicative of preparation by a user for administration of a dose of the medication;

a temperature sensor in electrical communication with the controller, the temperature sensor configured to detect confirming temperatures on or near the inhaler within a second time window of any signature motions, the temperature sensor configured to be within a given distance of the mouth of the user, the temperatures indicative of a proper dosage breathing pattern, the temperatures indicative that a dose of the medication was administered;

a mobile personal computing device remote from the housing and configured to receive data from the inhaler communication interface, the computing device having a processor configured to:

process data output from the motion sensor to identify signature motions by comparison to reference data from a database, the reference data indicating sensor results indicative of preparation by a user and proper administration of a dose of the medication;

process data output from the temperature sensor to identify confirming temperatures indicative of proper administration of a dose of the medication; and

evaluate timing of any signature motions in the first time window and confirming temperatures in the second time window to determine whether a use of the inhaler has occurred; and

cause the mobile personal computing device to display information to the user related to compliance with the medication dosage regimen.

2. The monitor ofclaim 1 wherein evaluating the timing includes determining whether the temperature data indicative of use occurred later in time than the motion data indicative of use.

3. The monitor ofclaim 1 wherein the confirming temperatures comprise a temperature increase in proximity to a mouthpiece connected to the housing of the inhaler.

4. The monitor ofclaim 1 wherein the confirming temperatures comprise a temperature increase by an amount indicative of a patient's mouth being in proximity to a mouthpiece connected to an inhaler housing.

5. The monitor ofclaim 1 wherein the controller is configured to process data output from the motion sensor to identify signature motions that result from a lever being actuated on a DPI inhaler.

6. A method of using a disposable sensor package in communication with a mobile personal computing device, the method comprising:

attaching a disposable package comprising one or more sensors to an inhaler;

using at least one sensor in the disposable package to detect data relating to signature motions that comprise at least two movements of the inhaler and indicative of preparation by a user and administration of a dose of the medication;

using at least one sensor in the disposable package to detect one or more temperatures using a sensor outside and near the mouth of the user within a time window of any signature motions, the temperatures indicative of a dosage breathing pattern for medication dosage;

using an inhaler communication interface within the disposable package to transmit the motion and temperature data to a mobile personal computing device of the user;

using the mobile personal computing device to process the motion data to determine whether it includes one or more signature motions indicative of proper preparation and use of the inhaler;

using the mobile personal computing device to process the temperature data to determine whether it is indicative of proper dosage breathing patterns for effective medication dosage; and

using the mobile personal computing device to evaluate the timing of the signature motion data relative to the temperature data to determine whether the inhaler has been properly used.

7. The method ofclaim 6, further comprising associating a date, time, and location with a use after the evaluating step has confirmed that a proper use of an inhaler has occurred.

8. The method ofclaim 6, wherein the disposable package includes a temperature sensor configured to measure the temperature of a medication container and the processing of the temperature data includes determining whether a temperature of the inhaler container has changed.

9. The method ofclaim 6, wherein using the mobile personal computing device to process the motion data includes determining whether a frequency of the acceleration reaches a threshold magnitude and the duration of acceleration above the threshold.

10. A universal monitor system for detecting and assessing usage of an inhaler, the monitor system comprising:

a compact housing configured to be removably connectable to an inhaler;

a controller;

an inhaler communication interface in electronic communication with the controller;

at least two sensors in the compact housing and configured to be physically present during inhaler use, the sensors including at least two of the following:

a motion sensor;

an accelerometer;

a temperature sensor;

a proximity sensor;

an infrared sensor;

an audio sensor; and

a vibration sensor;

a mobile personal computing device remote from the compact housing and configured to receive data from the inhaler communication interface, the computing device having a processor configured to:

process data output from the at least two sensors to identify at least two relevant sensor readings;

process data output from the at least two sensors to assess if the sensor readings are signature readings, indicating proper administration of a dose of the asthma medication; and

evaluate timing of any signature readings to determine or confirm whether a proper use of the asthma inhaler has occurred; and

a user display configured to receive output from the processor and indicate whether or not proper usage and compliance with the medication dosage regimen has occurred.

11. The universal monitor system ofclaim 10, wherein:

the compact housing is configured for connection to at least two of the following inhaler types: metered dose inhaler, dry powder inhaler, disk inhaler, and nebulizer;

the at least two sensors are selected to provide data relevant to assess proper medication dosage from at least the two inhaler types; and

the processor is configured to assess signature readings for the at least two inhaler types so that the universal monitor can be used on either type and is not specific to only one type of inhaler.

12. The universal monitor ofclaim 11 wherein the at least two sensors comprise perpendicular accelerometers.

13. The accelerometer ofclaim 12 wherein the accelerometers monitor motion data for acceleration with respect to at least one reference acceleration in each of two perpendicular dimensions.

14. The universal monitor ofclaim 11 wherein the at least two sensors comprise a gyroscope that monitors orientation.

15. The universal monitor ofclaim 12 wherein the at least two sensors comprise a temperature sensor that monitors changes in temperature in proximity of the inhaler related to medication dispensation or mouth proximity.

16. The universal monitor ofclaim 12 wherein the at least two sensors comprises an infrared proximity sensor that monitors proximity of the inhaler to the user's face.

17. The universal monitor ofclaim 12 wherein the at least two sensors comprise an audio sensor that monitors sounds generated by the user and inhaler during use of the device.

18. The universal monitor ofclaim 12 wherein the at least two sensors comprise a vibration sensor that monitors for a distinct vibration associated with use of the inhaler.

19. The universal monitor ofclaim 11 wherein the at least two sensors comprise multiple temperature sensors, including an ambient temperature sensor that monitors ambient temperature to provide a reference temperature.

20. The universal monitor ofclaim 11 wherein the processor is configured to send a notification to the user that the cartridge is at a certain capacity, to request the user to order a refill cartridge, to receive a command from the user to order the refill cartridges, to connect to a network, or to directly order the refill cartridges.

Images