Systems and devices for alignment of a respiratory therapy device to user anatomy and / or providing resistance to exhaltion while using a respiratory therapy device and methods of use thereof

Abstract

Respiratory therapy device alignment mechanisms may be configured to provide feedback to a user regarding the his / her / their alignment with a respiratory therapy device during use. This feedback may be used to increase efficacy and / or comfort using the respiratory therapy device. Additionally, or alternatively, one-way valves that cooperate with mouthpieces of respiratory therapy devices may be configured to provide resistance to a flow of gas exiting a user when the user exhales may also increase treatment efficacy by, for example, increasing the time it takes for the user to fully exhale, thereby allowing more time for gravitational settling of particles onto the user's lung tissue.

Description

SYSTEMS AND DEVICES FOR ALIGNMENT OF A RESPIRATORY THERAPY DEVICE TO USER ANATOMY AND / OR PROVIDING RESISTANCE TO EXHALTION WHILE USING A RESPIRATORY THERAPY DEVICE AND METHODS OF USE THEREOFRELATED APPLICATIONSThis application is an INTERNATIONAL (PCT) application of, and claims priority to, United States Provisional Patent Application Number: 63 / 684,257, filed on 16 August 2024 and entitled “RESPIRATORY THERAPY DEVICE WITH ONE OR MORE ONE-WAY VALVES” and United States Provisional Patent Application Number: 63 / 684,206, filed on 16 August 2024 and entitled “SYSTEMS AND DEVICES FOR ALIGNMENT OF A RESPIRATORY THERAPY DEVICE TO USER ANATOMY AND METHODS OF USE THEREOF,” both of which are incorporated herein by reference in their respective entireties.BACKGROUND

[0001] Effective medication delivery through metered dose inhalers (MDIs) presents several challenges for users with respiratory conditions. Users are often instructed to begin inhaling simultaneously with activating the MDI and / or triggering the MDI to dispense medication into their mouths so that the medication is carried by the inhaled breath through the airway and down into the distal parts of the lungs. When a user fails to do this, the medication sprayed into the mouth may be deposited on a surface of mouth and / or throat rather than reaching the lungs as intended, thereby significantly reducing medication’s effectiveness.

[0002] Another error that frequently occurs with MDI usage is improper alignment of the inhaler with user anatomy. For example, if the inhaler is not pointed directly towards the back of the user’s throat (e.g., toward the roof and / or side of the mouth), some, or all, of the medication may be deposited on the surface of the mouth and not be properly inhaled and delivered to the lungs effectively.

[0003] Other respiratory devices suffer from decreased efficacy when not properly aligned with the user’s face, mouth, nose, and / or throat.SUMMARY

[0004] Systems and devices disclosed herein may include a respiratory therapy device alignment mechanism configured to cooperate with a respiratory therapy device (e.g., a metered dose inhaler, a dry powder inhaler, a spirometer, a soft mist inhaler (SMI), an incentive spirometer, an oscillating positive expiratory pressure (oPEP) device, a positive expiratory pressure (PEP) device, a peak flow meter, a respiratory muscle trainer, a valved holding chamber / spacer, a nebulizer, and a small volume nebulizer (SVN)) and providefeedback to a user regarding the user’s alignment with the respiratory therapy device or a portion (e.g., a mouthpiece, canister of medication, and / or canister housing) of the respiratory therapy device. The feedback may regard whether, for example, the user’s face, nose, mouth, and / or neck may be properly aligned with the respiratory therapy device. In some embodiments, the respiratory therapy device alignment mechanism may be integrated into a portion (e.g., mouthpiece, canister holder, etc.) of the respiratory therapy device. Alternatively, the respiratory therapy device alignment mechanism may be removably attached to a portion (e.g., mouthpiece, canister holder, etc.) of the respiratory therapy device.

[0005] In some embodiments, the respiratory therapy device alignment mechanism may be configured to align with a septum of the user’s nose, an interior of a nostril of the user’s nose, a bridge of the user’s nose, a portion of the user’s epidermis on a side of the user’s nostril, the user’s throat, and / or the user’s mouth.

[0006] In some embodiments, the respiratory therapy device alignment mechanism may include a sensor system that includes one or more sensors or measurement devices including, but not limited to, a camera, an accelerometer, a motion sensor, a sound producing device, an acoustic and / or vibration sensor, and / or a microphone. When the sensor is embodied as a camera, the camera may be configured to take an image of the user’s face while the user may be using the respiratory therapy device. This image may then be provided to the user via, for example, a software application running on a user device (e.g., a smart phone or smart watch) so the user can visualize where the respiratory therapy device (or a portion thereof) is positioned relative to the user’s face or anatomy. In some embodiments, the software application may provide additional information like a target or other visual indicator superimposed upon the image of the user to assist the user in aligning the respiratory device with the user’s face and / or anatomy.

[0007] In some instances, the sensor system may include a memory configured to store a measurement taken by a sensor (e.g., the accelerometer, microphone, sound producing device, and / or acoustic and / or vibration sensor) and / or a transceiver configured to communicate a measurement taken by a sensor to an external device.

[0008] The systems and devices disclosed herein that include a respiratory therapy device alignment mechanism may be used provide feedback to a user regarding the user’s alignment with the respiratory therapy device so that, for example, the user may learn how to properly use the respiratory therapy device and / o improve the efficacy of the respiratory therapy delivered by the respiratory therapy device.

[0009] Additionally, or alternatively, the systems and devices disclosed herein may comprise a one-way valve configured for cooperation with a mouthpiece of a respiratory therapydevice that includes a container or cannister of medication and a medication conduit configured to communicate medication from the container / cannister to the mouthpiece for inhalation by the user. The one-way valve may be configured to allow gas to flow from the medication conduit into the user’s mouth but provides resistance to a flow of gas from the user’s mouth into the medication conduit to, for example, prevent a back flow of gas from the user’s mouth into the container / canister of medication and / or provide resistance to an exhalation of a user, thereby prolonging the time it takes for the user to exhale (and increasing the time the medication is in the user’s lungs, which facilitates absorption by the lung tissue). The one-way valve may be integrated into the mouthpiece or removably attached to the mouthpiece as, for example, an add-on device. Removal of the one-way valve may facilitate cleaning of the one-way valve.

[0010] In some embodiments, a degree of resistance the one-way valve provides to a flow of gas entering the medication conduit may be variable and / or user configurable via, for example, a valve adjustment mechanism that may be embodied as, for example, a lever or dial that is in communication with the one-way valve and / or a membrane or other device providing the resistance to the gas flow. In some embodiments, the one-way valve may be a duckbill valve and the resistance of the one-way valve may be varied by altering the level of tension, or force, with which the two bills of the duckbill valve are held together.

[0011] In some cases, the system and / or device with the one-way valve may include a vent configured to vent gas exhaled by the user from the mouthpiece so that, for example, it does not enter a medication conduit and / or come into contact with a source of the medication (e.g., cannister or container).

[0012] In some cases, the systems and / or devices disclosed herein may be used by receiving information from a sensor system in physical communication with a respiratory therapy device while a user may be using the respiratory therapy device; determining a characteristic of the information; determining whether the user may be using the respiratory therapy device correctly responsively to the characteristic; and providing an indication of whether the user may be using the respiratory therapy device correctly to the user and / or a caregiver for the user. In some cases, the received information may be a sound recording of the user using, or otherwise interacting with, (e.g., shaking, activating, inhaling, and / or exhaling) the respiratory therapy device. Exemplary characteristics of the sound recording include, but are not limited to, a duration of an exhalation, a duration of an inhalation, an identification of when medication may be released from a cannister of the respiratory therapy device, and / or an indication that the user may be holding his or her breath following inhalation of medication from the cannister.

[0013] In some embodiments, the received information may be an image of the user’s face while the user may be using the respiratory therapy device and the characteristic of the image may be a position of the respiratory therapy device relative to a feature (e.g., nose, mouth, eyes, etc.) of the user’s face. In some cases, an image of the user’s face may be provided to the user (via, for example, a software application running on a user device) with an image and / or icon representing, for example, the respiratory therapy device and / or a target superimposed thereon. Additionally, or alternatively, the received information may be accelerometry information, and the characteristic may be at least one of an orientation of the respiratory therapy device and an indication of movement of the respiratory therapy device.BRIEF DESCRIPTION OF DRAWINGS

[0014] The accompanying drawings, which are incorporated in and constitute a part of this disclosure, illustrate exemplary embodiments and, together with the description, serve to explain the disclosed invention.

[0015] FIG. 1 is a block diagram of exemplary components included in a sensor system for use with a respiratory therapy device, in accordance with some embodiments of the present invention;

[0016] FIG. 2A is a schematic diagram of a side view of an exemplary reparatory therapy device, in accordance with some embodiments of the present invention;

[0017] FIG. 2B is a schematic diagram of a front view of the exemplary reparatory therapy device of FIG. 2A, in accordance with some embodiments of the present invention;

[0018] FIG. 2C is a schematic diagram of a side view of a first exemplary respiratory therapy device, in accordance with some embodiments of the present invention;

[0019] FIG. 2D is a schematic diagram of a front view of the first exemplary respiratory therapy device of FIG. 2C, in accordance with some embodiments of the present invention;

[0020] FIG. 2E is a schematic diagram of a side view of a first exemplary alignment attachment, in accordance with some embodiments of the present invention;

[0021] FIG. 2F is a schematic diagram of a front view of the first exemplary alignment attachment of FIG. 2E, in accordance with some embodiments of the present invention;

[0022] FIG. 2G is a schematic diagram of a side view of an assembly of the first exemplary alignment attachment of FIG. 2E and the reparatory therapy device of FIG. 2A, in accordance with some embodiments of the present invention;

[0023] FIG. 2H is a schematic diagram of a front view of the assembly of FIG. 2G, in accordance with some embodiments of the present invention;

[0024] FIG. 3A is a schematic diagram of a side view of a second exemplary respiratory therapy device, in accordance with some embodiments of the present invention;

[0025] FIG. 3B is a schematic diagram of a front view of the second exemplary respiratory therapy device of FIG. 3A, in accordance with some embodiments of the present invention;

[0026] FIG. 3C is a schematic diagram of a side view of a second exemplary alignment attachment, in accordance with some embodiments of the present invention;

[0027] FIG. 3D is a schematic diagram of a front view of the second exemplary alignment attachment of FIG. 3C, in accordance with some embodiments of the present invention;

[0028] FIG. 3E is a schematic diagram of a side view of an assembly of the second exemplary alignment attachment of FIG. 3C and the reparatory therapy device of FIG. 2A, in accordance with some embodiments of the present invention;

[0029] FIG. 3F is a schematic diagram of a front view of the assembly of FIG. 3E, in accordance with some embodiments of the present invention;

[0030] FIG. 4A is a schematic diagram of a side view of a third exemplary respiratory therapy device, in accordance with some embodiments of the present invention;

[0031] FIG. 4B is a schematic diagram of a front view of the third exemplary respiratory therapy device of FIG. 4A, in accordance with some embodiments of the present invention;

[0032] FIG. 4C is a schematic diagram of a side view of a third exemplary alignment attachment, in accordance with some embodiments of the present invention;

[0033] FIG. 4D is a schematic diagram of a front view of the third exemplary alignment attachment of FIG. 4C, in accordance with some embodiments of the present invention;

[0034] FIG. 4E is a schematic diagram of a side view of an assembly of the third exemplary alignment attachment of FIG. 4C and the reparatory therapy device of FIG. 2A, in accordance with some embodiments of the present invention;

[0035] FIG. 4F is a schematic diagram of a front view of the assembly of FIG. 4E, in accordance with some embodiments of the present invention;

[0036] FIG. 5A is a schematic diagram of a side view of a fourth exemplary respiratory therapy device, in accordance with some embodiments of the present invention;

[0037] FIG. 5B is a schematic diagram of a front view of the fourth exemplary respiratory therapy device of FIG. 5A, in accordance with some embodiments of the present invention;

[0038] FIG. 5C is a schematic diagram of a side view of a fourth exemplary alignment attachment, in accordance with some embodiments of the present invention;

[0039] FIG. 5D is a schematic diagram of a front view of the fourth exemplary alignment attachment of FIG. 5C, in accordance with some embodiments of the present invention;

[0040] FIG. 5E is a schematic diagram of a side view of an assembly of the fourth exemplary alignment attachment of FIG. 5C and the reparatory therapy device of FIG. 2A, in accordance with some embodiments of the present invention;

[0041] FIG. 5F is a schematic diagram of a front view of the assembly of FIG. 5E, in accordance with some embodiments of the present invention;

[0042] FIG. 6A is a schematic diagram of a side view of a fifth exemplary respiratory therapy device, in accordance with some embodiments of the present invention;

[0043] FIG. 6B is a schematic diagram of a front view of the fifth exemplary respiratory therapy device of FIG. 6A, in accordance with some embodiments of the present invention;

[0044] FIG. 7A is a schematic diagram of a side view of a sixth exemplary respiratory therapy device, in accordance with some embodiments of the present invention;

[0045] FIG. 7B is a schematic diagram of a front view of the sixth exemplary respiratory therapy device of FIG. 7A, in accordance with some embodiments of the present invention;

[0046] FIG. 8A is a schematic drawing of a side view of an assembly including a medication inhaler and a one-way valve, in accordance with some embodiments of the present invention;

[0047] FIG. 8B is a front view of the assembly of FIG. 8A, in accordance with some embodiments of the present invention;

[0048] FIG. 9 is a block diagram of an exemplary system, in accordance with some embodiments of the present invention; and

[0049] FIG. 10 provides a flowchart of an exemplary method of using a respiratory therapy device, in accordance with some embodiments of the present invention.

[0050] therapy device, in accordance with some embodiments of the present invention;

[0051] Throughout the drawings, the same reference numerals and characters, unless otherwise stated, are used to denote like features, elements, components, or portions of the illustrated embodiments. Moreover, while the subject invention will now be described in detail with reference to the drawings, the description is done in connection with the illustrative embodiments. It is intended that changes and modifications can be made to thedescribed embodiments without departing from the true scope and spirit of the subject invention as defined by the appended claims. In addition, it should be noted that the dimensions provided by some of the drawings are exemplary only.WRITTEN DESCRIPTION

[0052] The present invention aims to address challenges users of respiratory therapy devices face by providing tools and methods to assist them with properly aligning the respiratory therapy device with their respective anatomy (e.g., mouth, throat, nose, etc.) and utilization of clinically-validated device techniques. Exemplary respiratory therapy devices include, but are not limited to, MDIs, dry powder inhalers (DPIs) spirometers, soft mist inhalers (SMIs), incentive spirometers, oscillating positive expiratory pressure (oPEP) and positive expiratory pressure (PEP) devices, peak flow meters, respiratory muscle trainers, valved holding chambers / spacers and small volume nebulizers (SVNs). For the sake of discussion, the following description of the invention is provided using the example of a respiratory therapy devices embodied as an MDI or DPI but, it will be appreciated that the systems, devices, and methods disclosed herein may be used with and / or adapted for use with a different respiratory therapy device (e.g., a spirometer, an incentive spirometer, an oPEP / PEP device, SMI, a peak flow meter, MDI spacing devices, a respiratory resistance trainer, and / or a nebulizer).

[0053] The systems, devices, and / or components thereof disclosed herein may be an attachment to and / or integrated into a respiratory therapy device and / or a housing for a respiratory therapy device. In some embodiments, the systems, devices, and / or components thereof disclosed herein may be configured to communicate and / or cooperate with external user and / or processing devices configured to, for example, receive, store, compress, and / or analyze data from the systems, devices, and / or components thereof disclosed herein. These external processing devices may include, but are not limited to, smart phones, computers, ASICs, cloud-computing environments, and / or dedicated processing and / or display devices, and / or a user device like user device 920 of FIG. 9.

[0054] Taking the example of a respiratory therapy device embodied as a MDI or DPI, the systems, devices, and methods disclosed herein improve a user’s ability to align their MDI / DPI with his or her anatomy (e.g., mouth and throat) so that medication may be properly directed into the user’s airway so that it may travel to the lungs, thereby providing more effective medication delivery to the lungs and improving therapeutic outcomes for users while reducing side-effects associated with medication in the user’s mouth. In some embodiments, tactile feedback from, for example, extensions, bumps, ridges, and / or textures present on an upper surface of a mouthpiece configured for cooperation with and / orintegrated into an MDI may be used to provide a user with a tactile indication of where their nose, or a portion of their nose (e.g., nostril and / or nasal septum) is relative to the mouthpiece and, by extension, the MDI / DPI. Additionally, or alternatively, a camera or light sensor may be used to image a user’s face and / or sense colors or light levels proximate to and / or associated with the user’s face when an MDI / DPI mouthpiece is positioned proximate to and / or in the user’s mouth. In these embodiments, the cameras / sensors may be configured to provide detected / captured images, colors, and / or light levels to an outside computing device (e.g., smart phone, computer, etc.) configured to, for example, recognize where the MDI / DPI is in relation to the user’s face and / or provide feedback to the user regarding position and / or orientation of the MDI / DPI that may assist the user with optimizing placement and / or orientation of the MDI / DPI prior to and / or during use.

[0055] Exemplary instructions for use of a medication inhaler (e.g., an MDI, DPI, and / or SMI) include shake the inhaler (this step is only important for MDIs (step 1 ), exhale fully to empty lungs (step 2), remove the cap (if necessary) and place inhaler mouthpiece into the user’s mouth and begin to inhale (step 3), dispense medication by, for example, activating the medication inhaler apparatus (e.g., press down on canister of medication) and complete a deep inhalation (step 4), hold your breath for as long as you comfortably can, up to 10 seconds following complete dispensation of a dose of medication to allow the medication to settle in the lungs and / or contact lung tissue (step 5), and exhale slowly and then breathe normally (step 6). Among other things, proper execution of this technique helps maximize deposition of the medication within the lungs, maximizes the effectiveness of the medication, and ensures better management of respiratory conditions. In addition, some medication inhalers need to be primed prior to their first use, on some occasions, over time (e.g., every 1-3 weeks) and this step would be performed prior to step 1 as needed.

[0056] Holding one's breath after using a medication inhaler (step 5) is an important aspect of medication inhaler usage technique because it ensures the medication is effectively delivered to a maximum amount of lung surface area, which yields to the distribution of the medication throughout lungs so that maximum effectiveness of the medication may be achieved. There are several reasons for this. For example, when a user of a medication inhaler holds his or her breath, it provides more time for the medication to travel throughout and / or be distributed into the lungs where it can exert its maximal therapeutic effects. This is particularly important for lower regions of the lungs and / or regions further away from major bronchi because it takes longer for medication to reach these regions of the lungs. These benefits are not fully achieved if the user exhales too quickly because the medication is exhaled prior to it being in contact with all regions of the lungs. Despite these benefits, patients often neglect, or under-perform (e.g., don’t hold theirbreath for long enough) this step, thereby adversely impacting the therapeutic benefits of distributing the medication throughout the lungs.

[0057] Medication inhalers are designed for a mixture of air and medication to be inhaled by the user. Users are typically discouraged from exhaling into the inhaler as may occur when executing step 2, above, for, among other reasons, risk of contamination or compromising the effectiveness and proper functioning of DPIs and SMIs. To mitigate the risk of contamination, device function and / or provide other benefits such as improved medication inhaler technique and / or improved medication efficacy, the systems and / or devices disclosed herein may include a mouthpiece with a mechanism to resist air flow (e.g., a one-way valve) and channel through which a user may exhale (step 2) before beginning their inhale (step 4) and / or after holding their breath (step 6) without needing to take their mouth off the mouthpiece. The one-way valve may be configured to prevent exhaled air from entering the body of the inhaler housing and / or canister where it could cause contamination.

[0058] The behavior of gas and aerosolized particles in the lungs is, in part, predicted by Dalton’s Law of Partial Pressures and Boyle’s Law. Dalton’s Law of Partial Pressures states that the total pressure of a mixture of gases is equal to the sum of the partial pressures of the individual gases within the mixture. When a user holds his / her / their breath, air in the lungs remains a mixture of gases (primarily nitrogen, oxygen, and carbon dioxide). As oxygen is absorbed and carbon dioxide is released by lung tissue, the partial pressures of these individual gases change within the gas mixture within the user’s lungs, even if the overall pressure within the lungs remains relatively constant. In addition, Boyle's law describes an inverse relationship between pressure and volume of a gas at constant temperature and plays a direct role in the slight volume decrease of gas within the user’s lungs during breath-holding (due to gas exchange) while maintaining overall constant pressure. The initial act of holding your breath, involving the closure of the glottis, essentially creates a closed system for gas within the user’s lungs and, while Boyle's law highlights the relationship between pressure and volume, in the specific context of holding your breath, the slight change in the volume of gases in the user’s lungs (due to, for example, gas exchange) doesn't necessarily lead to a proportional pressure change because the body's respiratory system attempts to maintain a relatively constant pressure within the lungs, despite the ongoing gas exchange.

[0059] When a user exhales against resistance, several things happen in his / her / their respiratory system. When a user holds his / her / their breath, there is an increase in the user’s intrapleural pressure because the muscles involved in forced exhalation (like the abdominal muscles) contract, pushing against the diaphragm and increasing pressure inthe thorax. This increased intrapleural pressure can compress and narrow the smaller airways within the lungs leading to airway compression and potential collapse. In healthy individuals, the airway's cartilaginous support and the pressure of the air inside lung tissue help prevent complete collapse during passive expiration. However, with increased expiratory effort and high intrapleural pressure, particularly in individuals with compromised lung health (like those with chronic obstructive pulmonary disease (COPD)), these airways may collapse, trapping air in the lungs. In some cases, when airways collapse during exhalation, air can be trapped in the lung, leading to an increase in the end-expiratory lung volume or "dynamic hyperinflation". This can cause a feeling of shortness of breath and further restrict airflow. In addition, exhaling against resistance can increase the workload for expiratory muscles because exhaling against resistance forces the expiratory muscles to work harder to exhale, strengthening them over time. This principle is the basis of inspiratory / expiratory muscle training (IMT / EMT), which uses devices that create resistance during breathing to strengthen the respiratory muscles. Additionally, or alternatively, exhaling against resistance leads to increased intrathoracic pressure that may result in blood pressure fluctuations in the short term. However, controlled breathing exercises like inspiratory muscle strength training have been shown to help lower blood pressure in some cases.

[0060] One reason users of medication inhalers are instructed to hold their breath following inhalation of medication is to allow the small aerosol particles to distribute throughout the airways and / or maintain a relatively constant pressure within the lungs for a period of time. This gravitational settling over the time in which the user holds his or her breath forces the medication into the distal parts of the lung tissue, thereby increasing its efficacy and minimizing waste of medication that is subsequently exhaled.

[0061] In short, exhaling against resistance can increase the workload for your expiratory muscles, potentially lead to airway compression and air trapping, and affect blood pressure. While potentially problematic in some individuals with pre-existing lung conditions, this technique is also used therapeutically in respiratory muscle training to improve breathing strength and function. A similar effect of pressurizing the lungs may also be achieved via pressurized exhalation provided by, for example, backpressure and / or resistance to the exhalation. This backpressure and / or resistance may be provided by, for example, a resistance valve that resists escape of air from a medication inhaler mouthpiece unless it is at, or above, a predetermined pressure and / or velocity, which may indicate that the lungs are correctly pressurized to optimize medication effectiveness.

[0062] Turning now to the drawings, FIG. 1 is a block diagram of exemplary components included in a sensor system 100 for use with one or more embodiments of arespiratory therapy device disclosed herein. Sensor system 100 may include a housing 105, an imaging / light sensing device 110, one or more port(s) 115, an acoustic and / or vibration sensor 120, a power source 130, user interface 140, a transceiver 150, an accelerometer 160, a sound- and / or vibration-producing device 170, a processing device 180, and / or a memory 190. In some cases, sensor system 100 may not include all the components shown in FIG. 1 . For example, in some embodiments, sensor system 100 may not include imaging / light sensing device 110, user interface 140, accelerometer 160, sound-and / or vibration-producing device 170, processing device 180, and / or memory 190.

[0063] Housing 105 may be configured to be moisture and / or impact resistant and may be permanently and / or removably attached to a respiratory therapy device. When permanently attached, housing 105 may be integrated into the hardware of a respiratory therapy device and / or affixed via, for example, chemical, heat, and / or vibrational bonding. When removably attached, housing 105 may be attached to a respiratory therapy device via, for example, a magnet, VELCRO®, glue, and / or a mechanical attachment device such as a strap, clasp, and / or snap. Housing 105 may include one or more communication and / or power port(s) 105 that are configured to enable the charging of power source 130 (when embodied as a rechargeable battery) and / or communication with an external device such as a mobile phone, computer, and / or wearable device (e.g., a smart watch).

[0064] Imaging / light sensing device 110 may be configured to image a user’s face and / or detect light one and / or around the user’s face and / or facial features, which may then be stored on memory 190 and / or communicated to transceiver 150 for communication (via, for example, a near-field communication protocol (e.g., BLUETOOTH ®)) to an external processing device such as a smart phone, tablet computer, desktop computer, and / or cloudbased computing system for further processing and / or analysis. In some embodiments, the external processing device may display the images and / or light sensor information on a display device so that the user and / or a caregiver for the user may visualize where the camera / light sensor 110 is relative to the user’s face, mouth, and / or throat. In some embodiments, targeting information (e.g., lines, cross-hairs, and / or a bullseye) may be superimposed up on the image(s) to assist with moving and / or aligning system 700 with the user’s face and / or mouth. Power source 130 may be any power source and / or battery configured to provide power to the components of sensor system 100.

[0065] Acoustic and / or vibration sensor 120 may be configured to measure or detect vibrations and / or sound made by the user when, for example, interacting with and / or proximate to a respiratory therapy device and / or a component thereof. Exemplary acoustic and / or vibration sensor 120 include, but are not limited to, microphones and / or a device configured to measure a change in the amplitude, frequency, and / or intensity of vibrations ormovement of a respiratory therapy device and / or a component thereof. In some embodiments, acoustic and / or vibration measurements sensed by acoustic and / or vibration sensor 120 may be stored in memory 190 and / or communicated to transceiver 150 for communication to an external processing device.

[0066] User interface 140 may be any user interface configured to, for example, receive input from and / or provide output to a user. User interface 140 may be embodied as, for example, a button, a keypad, a speaker, a microphone, a touch screen, an indicator light, and a dial. Exemplary user input received via user interface 140 may include, for example, an on / off instruction, a selection of a program or routine the user is (or will be) using, and an instruction to communicate information stored in memory 190 to an external device. Exemplary output provided to a user via user interface 140 includes, but is not limited to, a message and / or graphic displayed on a display screen, a tone, a progress bar, and the lighting of an indicator light. In some embodiments, user interface 140 may be configured to provide feedback to a user regarding use of a respiratory therapy device and / or system 100 and / or images captured and / or determined by imaging / light sensing device 110. Additionally, or alternatively, user interface 140 may be configured to provide feedback to a user regarding one or more operations of, for example, acoustic and / or vibration sensor 120, transceiver 150, and / or power source 130. Additionally, or alternatively, user interface 140 may be configured to provide user feedback regarding when and / or for how long acoustic and / or vibration sensor 120 is sensing sound made by a user while, for example, breathing and / or interacting with a respiratory therapy device or a component thereof (e.g., one-way valve 830 and / or sound- and / or vibration-producing device 170). Additionally, or alternatively, user interface 140 may be configured to provide feedback to a user indicating that he or she has inhaled and / or exhaled for a predetermined length of time and / or has shaken the assembly for a predetermined length of time. User interface 140 may be embodied as, for example, one or more lights, speakers, and / or display windows and / or touch screens configured to display, for example, text and / or icons to the user and / or receive input from a user.

[0067] Sound-and / or vibration-producing device 170 may be any device configured to make a sound and / or vibration in response to, for example, movement of a respiratory device system and / or a flow of gas and / or medication through a component (e.g., mouthpiece and / or valve) of a respiratory therapy device as may occur when, for example, the user inhales medication and / or exhales. Exemplary movement includes, but is not limited to, shaking a respiratory therapy device, placing a mouthpiece of a respiratory therapy device into a user’s mouth, and / or a flow of gas and / or medication through a component (e.g., mouthpiece and / or valve) of a respiratory therapy device. Exemplarysound-and / or vibration-producing devices 170 may be mechanical and / or electronic and, in some instances, may include, but are not limited to, reeds, gaskets, ball-bearings, and electronic vibration devices (e.g., buzzers that may be activated responsively to, for example, a user command and / or movement of the respiratory therapy device). In some cases, air flow across and / or through sound-and / or vibration-producing device 170 may cause vibration by triggering a mechanism or causing turbulent or otherwise disturbed airflow.

[0068] Memory 190 may be any memory configured to store data and / or sets of instructions to be executed by processing device 180. Data stored on memory 190 may include, but is not limited to, measurements detected by imaging / light sensing device 110, acoustic and / or vibration sensor 120, accelerometer 160, sound- and / or vibration-producing device 170, inputs received from user interface 140 and / or communications received from and / or transmitted by transceiver 150. The sets of instructions stored in memory 190 may be configured to instruct processing device 180 to execute one or more methods disclosed herein and / or a step thereof. Additionally, or alternatively, the sets of instructions may be configured to instruct the processing device 180 to perform a particular function (e.g., on / off, record measurement, etc.) and / or set a time period for performance of the function. Processing device 180 may be any device configured to execute one or more instructions stored in memory 180 and / or provided via port 115 and / or user interface 140. Exemplary processing devices include, but are not limited to, field programmable gate arrays (FPGAs), application-specific integrated circuits (ASICs), and central processing units (CPUs).

[0069] Accelerometer 160 may be configured to, for example, an orientation in the X- , Y-, and / or Z-planes, proper acceleration, coordinate acceleration, and / or motion of a respiratory therapy device like the respiratory device systems disclosed herein and / or a component thereof.

[0070] FIG. 2A is a schematic diagram of a side view and FIG. 2B is a schematic diagram of a front view of an exemplary reparatory therapy device 205 that includes an optional cannister housing 210, a canister 215, a medication conduit 235, and a mouthpiece 220 with an opening 230. Optionally, respiratory therapy device 205 may include sensor system 100. Canister 215 may be a canister, or container, of medication configured for inhalation into a user’s lungs to, for example, relieve respiratory distress and / or improve breathing. Optional cannister housing 210 may be configured to house canister 215 and / or couple cannister 215 to mouthpiece 220. Mouthpiece 220 may be in communication with cannister 215 via medication conduit 235 and configured to fit into a user’s mouth so that, upon activation, medication from cannister 215 may be communicated to medication conduit 235 and directed into the user’s mouth via opening 230. Prior to and / or when the medicationis released from canister 215 into the opening, the user may inhale the medication into his or her lungs as directed and / or prescribed by, for example, a physician or health care provider. In some embodiments, respiratory therapy device 205 may be an MDI or DPI, and, in these embodiments, a method for using respiratory therapy device 205 may be similar to the use of these devices.

[0071] FIG. 2C is a schematic diagram of a side view and FIG. 2D is a schematic diagram of a front view of a first exemplary respiratory therapy device 200 that includes cannister 215, optional cannister housing 210, and an alignment mouthpiece 225 that includes a first nostril-alignment mechanism 240A positioned on and extending from a first side of an upper surface of mouthpiece 225, a second nostril-alignment mechanism 240B that is positioned on and extends from a second side of an upper (as oriented in the figures) surface of mouthpiece 225, an opening 245. First respiratory therapy device 200 may also optionally include sensor system 100. Additionally, or alternatively, first nostril-alignment mechanism 240A may be positioned on and extend from a first side of an outer surface of cannister and / or cannister housing 210 and a second nostril-alignment mechanism 240B may be positioned on and extend from a second side of an outer surface of cannister and / or cannister housing 210. A position and / or configuration of first and second nostril-alignment mechanisms 240A and 240B may be intended to align with a user’s respective first and second nostril so that first nostril-alignment mechanism 240A abuts and / or extends slightly into the user’s first nostril and the second nostril-alignment mechanism 240B abuts and / or extends slightly into the user’s second nostril and thereby provides tactile feedback to the user that his or her nostrils are aligned with first and second nostril-alignment mechanisms 240A and 240B and, therefore, cannister and / or cannister housing 210 and / or mouthpiece 225 are properly aligned with the user’s mouth and / or face prior to and / or during use. In some embodiments, some, or all, of first nostril-alignment mechanism 240A and / or second nostril-alignment mechanism 240B may extend from cannister housing 210 instead of, or in addition to, extending from the alignment mouthpiece.

[0072] In some embodiments, an alignment attachment (e.g., a sleeve, a removable, and / or a clip-on device) may be used to retrofit an existing respiratory therapy device with one or more of the alignment mechanisms and / or valves disclosed herein. For example, FIGs. 2E and 2F provide schematic diagrams of a side and a front view, respectively, of a first exemplary alignment attachment 250 configured as a sleeve 260 with an opening 265, first and second nostril-alignment mechanisms 240A and 240B, and optionally, sensor system 100. FIGs. 2G and 2H provide schematic diagrams of a side and a front view, respectively, of an assembly 270 of first alignment attachment 250 and respiratory therapy device 200. First and second nostril-alignment mechanisms 240A and 240B may beconfigured and / or arranged on sleeve 260 in a manner similar to their configuration and / or arrangement on first alignment mouthpiece 225 so that they provide tactile feedback to a user that his or her nose is properly aligned with the respiratory therapy device and / or a component thereof (e.g., opening 230).

[0073] Sleeve 260 may be embodied as, for example, a rigid and / or hard sleeve (e.g., plastic or vinyl) with an opening 265 that has dimensions configured to cooperate (e.g., slide over and / or clip onto an end thereof) with and / or fit over mouthpiece 220 in a manner that does not obstruct or obscure mouthpiece opening 230 as shown in FIGs. 2G and 2H. Additionally, or alternatively, sleeve 260 may be configured to be a flexible and / or expandable sleeve (e.g., silicone, a fabric strap, an elastic strap) configured to stretch and / or fit over a portion of mouthpiece 220 and be held in place by, for example, friction.

[0074] FIG. 3A is a schematic diagram of a side view and FIG. 3B is a schematic diagram of a front view of a second exemplary respiratory therapy device 300 that includes cannister 215, medication conduit 235, optional cannister housing 210, and an alignment mouthpiece 330. Optionally, second respiratory therapy device 200 may include sensor system 100 or components thereof. Alignment mouthpiece 320 is similar to alignment mouthpiece 225 except that it includes a first side-alignment mechanism 340A positioned on and extending from a first side of an upper surface of alignment mouthpiece 320 and a second side-alignment mechanism 340B that is positioned on and extends from a second side of an upper surface of alignment mouthpiece 320 as shown. Additionally, or alternatively, first side-alignment mechanism 340A may be positioned on and / or extend from a first side of an outer surface of cannister housing 210 and / or a second side-alignment mechanism 340B may be positioned on and extend from a second side of an outer surface of cannister housing 210.

[0075] A position and / or configuration of first side-alignment mechanism 340A may align with a first side of a user’s nose (e.g., epidermis proximate to a first nostril) and a position and / or configuration of second side-alignment mechanism 340A may align with a second side of the user’s nose (e.g., epidermis proximate to a second nostril) so that the user’s nose fits between first and second side-alignment mechanisms 340A and 340B and thereby provides tactile feedback to the user that his or her nose is aligned with first and second side-alignment mechanisms 340A and 340B and, therefore, alignment mouthpiece 320, cannister 215, and / or cannister housing 210 is / are properly aligned with the user’s mouth and / or face prior to and / or during use.

[0076] FIGs. 3C and 3D provide schematic diagrams of a side and a front view, respectively, of a second exemplary alignment attachment 350 configured as a sleeve 360 with an opening 365, first and second nostril-alignment mechanisms 340A and 340B, andoptionally, sensor system 100. FIGs. 3E and 3F provide schematic diagrams of a side and a front view, respectively, of an assembly 370 of second alignment attachment 350 and respiratory therapy device 200. First and second nostril-alignment mechanisms 340A and 340B may be configured and / or arranged on sleeve 360 in a manner similar to their configuration and / or arrangement on second alignment mouthpiece 320 so that they provide tactile feedback to a user that his or her nose is properly aligned with the respiratory therapy device and / or a component thereof (e.g., opening 230).

[0077] Sleeve 360 may include an opening 365 configured to cooperate with mouthpiece 220 and / or opening 230 so that it does not obscure and / or obstruct opening 230 and / or a path of medication from cannister 215 into the user’s mouth. In some embodiments, sleeve 360 may be embodied as, for example, a rigid and / or hard sleeve (e.g., plastic or vinyl) and, in these embodiments, opening 365 may be sized and / or configured to accept insertion of mouthpiece 220 therein as shown in, for example, FIGs. 3E and 3F. Additionally, or alternatively, sleeve 360 may be configured to be a flexible and / or expandable sleeve (e.g., silicone, a fabric strap, an elastic strap) configured to stretch and / or fit over a portion of mouthpiece 320 and be held in place by, for example, friction as shown in, for example, FIGs. 3E and 3F.

[0078] FIG. 4A is a schematic diagram of a side view and FIG. 4B is a schematic diagram of a front view of a third exemplary respiratory therapy device 400 that includes cannister 215, medication conduit 235, optional sensor system 100, mouthpiece 220 with opening 230, and a cannister housing 410 that includes a nose-bridge guide 440 positioned on an outer surface thereof as shown. Nose-bridge guide 444 may be sized, positioned, and / or configured to align with a bridge of a user’s nose to assist the user in aligning respiratory therapy device 400 to his or her anatomy to, for example, allow for proper inhalation of medication from cannister 210 into the user’s lungs.

[0079] FIGs. 4C and 4D provide schematic diagrams of a side and a front view, respectively, of a third exemplary alignment attachment 450 configured as a sleeve 460 with an opening 465, nose-bridge guide 440, and optionally, sensor system 100. FIGs. 4E and 4F provide schematic diagrams of a side and a front view, respectively, of an assembly 470 of third alignment attachment 450 and respiratory therapy device 200. Nose-bridge guide 440 may be configured and / or arranged on sleeve 460 in a manner similar to the configuration and / or arrangement on cannister housing 210 so that it provides tactile feedback to a user that his or her nose is properly aligned with the respiratory therapy device and / or a component thereof (e.g., opening 230).

[0080] Sleeve 460 may include an opening 465 configured to cooperate with cannister housing 210 and / or cannister 215 so that it fits over and / or attaches to cannisterhousing 210 and / or cannister 215 as shown in, for example, FIGs. 4E and 4F. In some embodiments, sleeve 460 may be embodied as, for example, a rigid and / or hard sleeve (e.g., plastic or vinyl) and, in these embodiments, opening 465 may be sized and / or configured to accept insertion of cannister housing 210 and / or cannister 215 therein as shown in, for example, FIGs. 4E and 4F. Additionally, or alternatively, sleeve 460 may be configured to be a flexible and / or expandable sleeve (e.g., silicone, a fabric strap, an elastic strap) configured to stretch and / or fit over a portion of mouthpiece 420 and be held in place by, for example, friction as shown in, for example, FIGs. 4E and 4F.

[0081] FIG. 5A is a schematic diagram of a side of view and FIG. 5B is a schematic diagram of a front view of a fourth exemplary respiratory therapy device 500 that includes cannister 215, medication conduit 235, optional cannister housing 210, and a mouthpiece 520. Optionally, respiratory therapy device 500 may include sensor system 100 or components thereof. Mouthpiece 520 includes a central opening 530 through which gas, air, and / or medication may flow from cannister 215 and / or medication conduit 235 into a user’s mouth. System 500 also includes a centrally-located alignment mechanism 540 that extends from an upper surface of mouthpiece 520 and / or outward from cannister housing 210 in an approximate center thereof as shown in FIG. 5B. Alignment mechanism 540 is configured, sized, and / or positioned to align with a user’s nasal septum when first system 500 is properly positioned and / or aligned with the user’s face and provide tactile feedback to the user that his or her nasal septum is in contact with centrally-located alignment mechanism 540 and, therefore, respiratory therapy device 500 and / or mouthpiece 520 is properly aligned with the user’s mouth and / or face prior to and / or during use.

[0082] FIGs. 5C and 5D provide schematic diagrams of a side and a front view, respectively, of a fourth exemplary alignment attachment 550 configured as a sleeve 560 with an opening 565, centrally-located alignment mechanism 540, and optionally, sensor system 100. FIGs. 5E and 5F provide schematic diagrams of a side and a front view, respectively, of an assembly 570 of second alignment attachment 550 and respiratory therapy device 200. Centrally-located alignment mechanism 540 may be configured and / or arranged on sleeve 560 in a manner similar to their configuration and / or arrangement on second alignment mouthpiece 520 so that it provides tactile feedback to a user that his or her nose is properly aligned with the respiratory therapy device and / or a component thereof (e.g., opening 230).

[0083] Sleeve 560 may include an opening 565 configured to cooperate with mouthpiece 220 and / or opening 230 so that it does not obscure and / or obstruct opening 230 and / or a path of medication from cannister 215 into the user’s mouth. In some embodiments, sleeve 560 may be embodied as, for example, a rigid and / or hard sleeve(e.g., plastic or vinyl) and, in these embodiments, opening 565 may be sized and / or configured to accept insertion of mouthpiece 220 therein as shown in, for example, FIGs. 5E and 5F. Additionally, or alternatively, sleeve 560 may be configured to be a flexible and / or expandable sleeve (e.g., silicone, a fabric strap, an elastic strap) configured to stretch and / or fit over a portion of mouthpiece 520 and be held in place by, for example, friction as shown in, for example, FIGs. 5E and 5F.

[0084] In some embodiments, nostril-alignment mechanisms 240A and / or 240B, side-alignment mechanism 340A and / or 340B, nose-bridge guide 440, and / or centrally- located alignment mechanism 540, may be flexible and / or compressible (e.g., made of memory foam) so that a dimension (e.g., height, width, orientation, degree of separation, etc.) thereof may be adjusted (e.g., compressed, angled inward, angled outward, elongated, thinned, stretched, and / or molded (e.g., memory foam or moldable plastic) to adapt to one or more dimensions of a user’s face including, but not limited to, nose width and distance between the user’s upper lip and nasal septum. In some embodiments, nostril-alignment mechanisms 240A and / or 240B, side-alignment mechanism 340A and / or 340B, nose-bridge guide 440, and / or centrally-located alignment mechanism 540 may be personalized to a user’s facial features and / or anatomy to ensure proper fit and / or operation. This personalization may be done using molds or impressions of the user’s face / anatomy, two- or three-dimensional scans of the user’s face / anatomy, and / or melting or otherwise softening the guide / alignment mechanism and form fitting it to the user’s face / anatomy so that the alignment mechanism / guide may take the form of the user’s face / anatomy as it hardens and / or cures.

[0085] FIG. 6A is a schematic diagram of a side view and FIG. 6B is a schematic diagram of a front view of a fifth exemplary respiratory therapy device 600 that includes a cannister and / or cannister housing 210 and a mouthpiece 620 with a bite extension 630 projecting therefrom. Optionally, fifth respiratory therapy device 600 may include sensor system 100 or components thereof. Bite extension 630 may be sized and / or configured for insertion into a user’s mouth prior to inhaling medication from the MDI system to assist with alignment of the MDI system with the user’s anatomy. In many cases, bite extension 630 includes a central opening 640 through which air and / or a combination of air and medication may flow into and / or out of the user’s mouth when the user inserts bite extension 630 into his or her mouth.

[0086] In some embodiments, the user’s engagement (e.g., biting down with the teeth and / or closing lips around it) with bite extension 630 may hold fifth respiratory therapy device 600 in a correct position and / or orientation relative to the user’s anatomy throughout the inhalation process thereby reducing the likelihood of medication misdirection within theuser’s mouth. In some embodiments, bite extension 630 may be configured to position fifth respiratory therapy device 600 far enough from the user’s nose that the nose does not cause fifth respiratory therapy device 600 to tilt to a position where the medication spray nozzle is pointing toward the roof of the user’s mouth rather than the back of their throat as desired. In some embodiments, mouthpiece 620 and bite extension 630 may be a single integrated device (e.g., molded and / or fabricated together) and, in other embodiments, bite extension 630 may be removable from mouthpiece 620.

[0087] FIG. 7A is a schematic diagram of a side view and FIG. 7B is a schematic diagram of a front view of a sixth exemplary respiratory therapy device 700 that includes a cannister housing 710, a mouthpiece 720, a first imaging / light sensing device 740, and a second imaging / light sensing device 750. Optionally, respiratory therapy device 700 may include sensor system 100 or components thereof. Mouthpiece 720 includes a central opening 330 similar to central opening 230 and cannister housing 710 may be similar to cannister housing 210 except that it is configured to house first imaging / light sensing device 740 and / or have first imaging / light sensing device 740 extending therefrom. Some embodiments of sixth respiratory therapy device 700 may have either or both of first and / or second imaging / light sensing device(s) 740 and / or 750. Addition

[0088] First imaging / light sensing device 740 may be configured and / or positioned on canister housing 210 to image a user’s face and / or a portion thereof and / or detect changes in light proximate to first imaging / light sensing device 740 as may occur when respiratory therapy device 700 is moved proximate to the user’s face. Second imaging / light sensing device 750 may be configured and / or positioned on mouthpiece 720 to image the underside of a user’s nose and / or nostril(s) and / or a portion thereof and / or detect changes in light proximate to second imaging / light sensing device 750 as may occur when respiratory therapy device 700 is moved proximate to the user’s face and / or mouthpiece 720 is inserted into the user’s mouth.

[0089] FIG. 8A is a schematic drawing of a side view of an assembly 800 including a medication inhaler 810 and a mouthpiece 820, FIG. 8B is a front view of assembly 800. Assembly 800 includes a medication inhaler 810 that includes a canister and / or cannister housing 210 of medication and a mouthpiece 820 that includes a one-way valve 830, a vent 840, an optional valve adjustment mechanism 850, a sound- and / or vibration-producing device 170, and an optional housing 160 for an acoustic and / or vibration sensor 120, a transceiver 150, a power source 830 and an optional user interface 140. In some embodiments, mouthpiece 820 may be removably attached to inhaler 810 so that, for example, it fits over a mouthpiece (not shown) of the inhaler as, for example, an add-ondevice. In some embodiments, assembly 800 may not include all components shown in FIGs. 8A and 8B.

[0090] One-way valve 830 may be any one-way valve configured to allow gas (e.g., a mixture of medication and air) to flow from canister 215 and / or cannister housing 210 into a user’s mouth for inhalation but not flow back into medication conduit 235, cannister 215, and / or cannister housing 210 when, for example, the user exhales. Instead, exhaled air may exit mouthpiece 820 via vent 840. One-way valve 830 may be instantized as, for example, a flip valve, a duck-bill valve, a check valve, a non-return valve, a reflux valve, and / or a retention valve. In some embodiments, one-way valve 830 may provide very little resistance to a flow of air and medication from medication conduit 235 and / or cannister 215 when the user is inhaling but may close when, for example, air / medication is not flowing through it and / or when the user is not inhaling through mouthpiece 820 to, for example, prevent contamination of canister 215, medication conduit 235, and / or cannister housing 210 or other portions of assembly 800 from, for example, exposure to exhaled breath. In some embodiments, a natural state for valve 830 may be open and it may only close in response to a flow of gas into mouthpiece 820 (i.e., may remain open until the user exhales into mouthpiece 820). Additionally, or alternatively, one-way valve 830 may be opened by the user prior to inhaling medication and / or closed by the user following inhalation and / or prior to exhaling via, for example, valve adjustment mechanism 850, a mechanical device and / or electrically activated switch 860, which may be in communication with processing device 180 and / or user interface 140 to, for example, receive instructions to open / close and / or adjust a degree of openness for one-way valve 830.

[0091] In some embodiments, vent 840 may be open to ambient air and provide no resistance to exhaled breath. Additionally, or alternatively, vent 840 may include and / or be a valve (e.g., a one-way valve) that, on some occasions, may be adjustable via, for example, cooperation with valve adjustment mechanism 850 to provide variable resistance to, for example, the pressure experienced by the user during their exhale and / or provide resistance so that air must be flowing at, or above, a pre-set, or adjustable, velocity to exit the valve of vent 840. In this way, the valve of vent 840 may provide resistance to the user’s exhalation that may act to pressurize the user’s lungs and / or push medication into lung tissue during exhalation. In some embodiments, valve adjustment mechanism 850 may be embodied as, for example, a mechanism to adjust a size of an opening or hole of vent 840 through which exhaled breath escapes mouthpiece 820, a mechanism to adjust a tension of a membrane covering an opening or hole of vent 840 through which exhaled breath escapes mouthpiece 820, and / or a mechanism to adjust a portion of an opening or hole of vent 840 through whichexhaled breath escapes mouthpiece 820 that is covered by, for example, a membrane or other device that may provide resistance to the flow of air through vent 840.

[0092] Additionally, or alternatively, variable resistance for the valve of vent 840 may be provided by, for example, different mouthpieces 820 that include vent valves of varying resistance such as light, medium, and strong resistance. In these embodiments, the user and / or prescriber (e.g., doctor or nurse) may select the mouthpiece / resistance for vent 840 valve that is appropriate to the user based on, for example, the user’s medical condition, compliance with instructions to hold his or her breath, rate of exhalation, lung strength, and / or combinations thereof. Additionally, or alternatively, variable resistance for one-way valve 830 and / or the valve of vent 840 may be achieved by changing (e.g., increasing and / or decreasing) a size of an opening of one-way valve 830 and / or the valve of vent 840 and / or changing a degree of resistance provided by a mechanism (e.g., spring or elastic component) that acts to hold an opening of one-way valve 830 and / or the valve of vent 840 closed. The amount of resistance provided by one-way valve 830 and / or the valve of vent 840 may be responsive to the air pressure exerted therein and, in some embodiments, may be tuned to open responsively to air of a certain pressure, thereby, for example, providing resistance to the user’s exhalation that may act to, for example, lengthen a time period required for a full exhalation and / or strengthen the muscles used while breathing.

[0093] In some embodiments, mouthpiece 820 and / or some components thereof may be configured as a removable attachment configured to be affixed to an existing respiratory therapy device (e.g., medication inhaler). In some embodiments, mouthpiece 820 may be disposable and / or configured for one-time use. Additionally, or alternatively, mouthpiece 820 and / or some components thereof may be integrated into a housing for a respiratory therapy device.

[0094] In the embodiment of FIGs. 8A and 8B, sound-and / or vibration-producing device 170 may be any device configured to make a sound and / or vibration in response to a flow of gas and / or medication through one-way valve 830 as may occur when, for example, the user inhales and / or exhales. In some instances, aspects of the sound and / or vibrations created by the sound-and / or vibration-producing device 170 may be responsive to a flow direction for gas within mouthpiece 820 and / or whether the gas has passed through, or been blocked by, one-way valve 830. For example, sound-and / or vibration-producing device 170 may be configured to make sound and / or vibration within a first range of frequencies when the user inhales and make sound and / or vibration within a second range of frequencies when the user exhales. Additionally, or alternatively, sound and / or vibration generated by sound- and / or vibration-producing device 170 may be responsive to a flow rate of gas withinmouthpiece 820. On some occasions, sound-and / or vibration-producing device 170 may be integrated into vent 840.

[0095] FIG. 9 is a block diagram of an exemplary system 900 in which one or more methods disclosed herein may be executed. System 900 includes respiratory therapy device 200, 300, 400, 500, 600, 700, 800, sensor system 100, a user device 920, and an optional communication network 710 (e.g., the Internet or Wi-Fi). System 900 may also optionally include a first imaging / light sensing device 740 and / or a second imaging / light sensing device 750. User device 720 may be any data processing device including, but not limited to, a computer, a smart phone, and a tablet computer, and a remote patient monitoring system. User device 720 may include a processor and a memory in which a set of instructions are stored. When the set of instructions are executed an operation of sensor system 100 and / or a component thereof may be controlled and / or activated and / or a method (or a step thereof) described herein may be executed. Additionally, or alternatively, user device 720 may be configured to operate (e.g., turn on / off, and / or control an operation thereof) of one or more components of sensor system 100, first imaging / light sensing device 740 and / or a second imaging / light sensing device 750. Communication between components of system 900 may be facilitated by communication network 910 and / or a wireless communication protocol (e.g., BLUETOOTH ®).

[0096] FIG. 10 provides a flowchart of an exemplary method 1000 of using a respiratory therapy device like the respiratory therapy devices disclosed herein, a sensor system like sensor system 100, and analyzing data received from the respiratory therapy device and / or sensor system to, for example, determine one or more characteristics of how the user is using the respiratory therapy device and / or provide feedback to the user regarding his or her usage of the respiratory therapy device. Method 1000 may be executed by a computing device like processing device 180 and / or user device 920 running a software application and / or executing a set of machine-readable instructions.

[0097] Optionally, in step 1005, information regarding a user and / or respiratory therapy device (e.g., respiratory therapy device 200, 300, 400, 500, 600, 700, and / or 800) used by a user may be received. Information about the user may include, but is not limited to, an identifier, a diagnosis, an indicator of lung health and / or strength, a type and / or dosage of medication prescribed to the user, a routine for use of the medication inhaler assembly prescribed to the user, and / or a user, physician, or caregiver preference. Information about the respiratory therapy device that may be received in step 1005 includes, but is not limited to, type, brand, manufacture, lot number, features of the medication (e.g., type, form factor for delivery, etc.) stored in a cannister, respiratory therapy device type and / or form factor, components included in a sensor system (e.g., sensor system 100) and / or components ofthe respiratory therapy device (e.g., whether the respiratory therapy device includes a vent valve and / or characteristics of the vent valve). In some embodiments, the information received in step 1005 may be encoded into an alphanumeric code and / or an optical code (e.g., barcode and / or QR code) that is scanned by a device (e.g., camera, RFID sensor, etc.) resident on, for example, a user device like user device 920.

[0098] In step 1010, information from the sensor system, an imaging / light sensing device like first and / or second imaging / light sensing device 740 and / or 750, and / or a component thereof (e.g., imaging / light sensing device 110, acoustic and / or vibration sensor 120, accelerometer 160, sound- and / or vibration-producing device 170, and / or processing device 180) may be received by, for example, a processing device like processing device 180 and / or a user device like user device 920) via, for example, a communication link (e.g., a wired and / or wireless communication link that may be facilitated by a communication network like communication network 910), a transceiver like transceiver 150, and / or a communication port like port 115.

[0099] The information received in step 1005 and / or 1010 may be analyzed to determine, for example, a characteristic thereof and / or one or more actions performed by the user (step 1015). Exemplary actions include, but are not limited to, shaking the respiratory therapy device, priming the respiratory therapy device, positioning the respiratory therapy device proximate to a user’s mouth, inhaling, exhaling, and holding his or her breath. Exemplary characteristics include, but are not limited to, a volume of medication held by a canister of the respiratory therapy device, a flow rate of medication out of the canister, a flow rate of air and / or medication going through and / or past sound- and / or vibration-producing device, a position of the respiratory therapy device, and / or a volume of air inhaled and / or exhaled by the user.[000100] In step 1020, the characteristic of step 1015 may be used to determine whether the user is using the respiratory therapy device correctly and, if so, the characteristic and / or an indication to proceed with using the respiratory therapy device may be provided to the user (step 1025). The indication may be provided via, for example, a user interface of the respiratory therapy device (e.g., user interface 140) and / or an interface of a user device (e.g., user device 920). Exemplary indications include a message, a tone, and / or activation of the indicator light. In some embodiments, the indication may be the absence of an error message and / or recommendation for adjusting the respiratory therapy device usage technique. When the user is not using the respiratory therapy device correctly, a recommendation and / or instruction regarding the use of the respiratory therapy device for the user and / or a caregiver of the user may be determined (step 1035).[000101] Optionally, in step 1040, the information received in step(s) 1005 and / or 1010, the characteristic, the indication of step 1025, the error message, and / or the recommendation may be stored in a database of, for example, user device 920 and / or an external device. In step 1045, the information received in step(s) 1005 and / or 1010, the characteristic, the indication of step 1025, the error message, and / or the recommendation may be provided to the user and / or a caregiver of the user via, for example, a user interface like user interface 140 and / or a display device of a user device like user device 920. [000102] In some embodiments, respiratory therapy device information received in step 1005 may indicate that the user is using an MDI or DPI and the information received in step 1010 may be an image of the user from imaging / light sensing device 110, first imaging / light sensing device 740, and / or second imaging / light sensing device 750. The image may be analyzed and / or processed in step 1015 using, for example, facial and / or image recognition software running on user device 920 and / or processing device 180 to, for example, identify one or more features of the image and / or when the image is of the user’s face, identify one or more features of the user’s face (e.g., eyes, mouth, bridge of the noes, nostril exterior (epidermis), and / or nostril interior. The identified features may then be used to determine where in space and / or relative to the user the respiratory therapy device, or a mouthpiece (e.g., mouthpiece 220) thereof is positioned and / or determine if the mouthpiece and / or respiratory therapy device is correctly oriented with the mouthpiece in the user’s mouth prior to deployment of medication from the cannister (e.g., canister 215) (step 1015 and / or 1020) and, if so, the user may be provided with an indication to proceed with use of the respiratory therapy device (e.g., activate the cannister to release medication) in the form of, for example, a beep or green light. If the mouthpiece and / or respiratory therapy device is not correctly oriented, then the user may be provided with an error message and / or recommendation for how to adjust a position and / or orientation of the respiratory therapy device and / or a portion thereof (step 1030 and / or 1035).[000103] In another example, respiratory therapy device information received in step 1005 may indicate that the user is using an MDI or DPI and the information received in step 1010 may be sound detected and / or recorded by acoustic and / or vibration sensor 120. In some embodiments, the detected sound and / or sound recording may include sounds made by The detected sound and / or sound recording may be analyzed and / or processed in step 1015 to, for example, identify one or more features of the detected sound and / or sound recording such as whether the user has exhaled prior to activation of the cannister and / or whether the user has properly prepared the respiratory therapy device for use (step 1020) and, if so, the user may be provided with an indication to proceed with use of the respiratory therapy device (e.g., activate the cannister to release medication) in the form of, for example, a beepor green light. If the respiratory therapy device is not being used correctly, then the user may be provided with an error message and / or a recommendation for how to, for example, better prepare the respiratory therapy system for use.[000104] In another example, respiratory therapy device information received in step 1005 may indicate that the user is using an MDI or DPI and the information received in step 1010 may be an accelerometer measurement and / or determination received from accelerometer 160. The accelerometer measurement may be analyzed and / or processed in step 1015 to, for example, identify a characteristic thereof (step 1015) so that it may be determined whether or not the respiratory therapy device is properly oriented in the X-, Y-, and / or Z- planes (step 1020) and, if so, the user may be provided with an indication to proceed with use of the respiratory therapy device (e.g., activate the cannister to release medication). If the respiratory therapy device is not correctly oriented, then the user may be provided with an error message and / or a recommendation for how to, for example, adjust an orientation of the respiratory therapy system for use.

Claims

CLAIMSWe claim:1 . A device comprising: a respiratory therapy device alignment mechanism configured to cooperate with a respiratory therapy device and provide feedback to a user regarding the user’s alignment with the respiratory therapy device.

2. The device of claim 1 , wherein the respiratory therapy device alignment mechanism is integrated into a portion of the respiratory therapy device.

3. The device of claim 1 , wherein the respiratory therapy device alignment mechanism is removably attached to a portion of the respiratory therapy device.

4. The device of claim 2 or 3, wherein the respiratory therapy device alignment mechanism is configured to cooperate with at least one of a mouthpiece, a canister of medication, and a canister housing of the respiratory therapy device.

5. The device of any of claims 1-4 wherein the respiratory therapy device alignment mechanism is configured to align with at least one of a septum of the user’s nose, an interior of a nostril of the user’s nose, a bridge of the user’s nose, a portion of the user’s epidermis on a side of the user’s nostril, the user’s throat, and the user’s lips .

6. The device of any of claims 1-5 wherein the respiratory therapy device alignment mechanism is a camera configured to take an image of the user’s face while the user is using the respiratory therapy device.

7. The device of any of claims 1-6, wherein the respiratory therapy device alignment mechanism comprises a sensor system.

8. The device of claim 7, wherein the sensor system includes at least one of an accelerometer, a microphone, a sound producing device, and an acoustic and / or vibration sensor.

9. The device of claim 8, wherein the sensor system includes at least one of a memory configured to store a measurement taken by the at least one accelerometer, microphone, sound producing device, and acoustic and / or vibration sensor and a transceiver configured to communicate a measurement taken by the at least one accelerometer, microphone, sound producing device, and acoustic and / or vibration sensor to an external device.

10. The device of any of claims 1-9, wherein the respiratory therapy device is at least one of a metered dose inhaler, a dry powder inhaler, a spirometer, a soft mist inhaler (SMI), an incentive spirometer, an oscillating positive expiratory pressure (oPEP) device, a positive expiratory pressure (PEP) device, a peak flow meter, a respiratory muscle trainer, a valved holding chamber / spacer, a nebulizer, and a small volume nebulizer (SVNs).11 . A system comprising; at least one of a metered dose inhaler and a dry powder inhaler; and the respiratory therapy device alignment mechanism of any of claims 1-10.

12. A method comprising: using the respiratory therapy device alignment mechanism of any of claims 1 -10 to provide feedback to a user regarding the user’s alignment with the respiratory therapy device.

13. A device comprising: a one-way valve configured for cooperation with a mouthpiece of a respiratory therapy device, the respiratory therapy device comprising a cannister of medication and a medication conduit configured to communicate medication from the cannister to the mouthpiece for inhalation by the user, wherein the one-way valve is configured to allow gas to flow from the medication conduit into the user’s mouth but provides resistance to a flow of gas from the user’s mouth into the medication conduit.

14. The device of claim 13, wherein the one-way valve is integrated into the mouthpiece.

15. The device of claim 13 or 14, wherein the one-way valve is removably attached to the mouthpiece.

16. The device of any of claims 13-15, wherein the respiratory therapy device is at least one of a metered dose inhaler and a dry powder inhaler.

17. The device of any of claims 13-16, wherein a degree of resistance the one-way valve provides to a flow of gas entering the medication conduit is variable.

18. The device of claim 17, wherein the variability of the resistance is controlled via a valve adjustment mechanism.

19. The device of any of claims 13-18, further comprising: a vent configured to vent gas exhaled by the user from the mouthpiece.

20. A system comprising; at least one of a metered dose inhaler and a dry powder inhaler; and the one-way valve of any of claims 13-18.21 . A processor-implemented method comprising: receiving information from a sensor system in physical communication with a respiratory therapy device while a user is using the respiratory therapy device; determining a characteristic of the information; determining whether the user is using the respiratory therapy device correctly responsively to the characteristic; and providing an indication of whether the user is using the respiratory therapy device correctly to the user.

22. The method of claim 21 , wherein the received information is a detected sound or sound recording of the user interacting with the respiratory therapy device.

23. The method of claim 22, wherein the characteristic of the detected sound or sound recording is at least one of a duration of an exhalation, a duration of an inhalation, an identification of when medication is released from a cannister of the respiratory therapy device, and an indication that the user is holding his or her breath following inhalation of medication from the cannister.

24. The method of claim 21 , wherein the received information is an image of the user’s face while the user is using the respiratory therapy device.

25. The method of claim 24, wherein the characteristic of the image is a position of the respiratory therapy device relative to a feature of the user’s face.

26. The method of claim 24 or 25, wherein the indication is an image of the user’s face with at least one of the respiratory therapy device and a target superimposed thereon.

27. The method of claim 21 , wherein the received information is accelerometry information, and the characteristic is at least one of an orientation of the respiratory therapy device and movement of the respiratory therapy device.

28. The method of any of claims 21-27, wherein the respiratory therapy device is at least one of a metered dose inhaler, a dry powder inhaler, a spirometer, a soft mist inhaler (SMI), an incentive spirometer, an oscillating positive expiratory pressure (oPEP) device, a positive expiratory pressure (PEP) device, a peak flow meter, a respiratory muscle trainer, a valved holding chamber / spacer, a nebulizer, and a small volume nebulizer (SVNs).

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