WO2023122020A1

WO2023122020A1 - Air flow monitoring device suitable for pediatric use

Info

Publication number: WO2023122020A1
Application number: PCT/US2022/053368
Authority: WO
Inventors: Taylor FARNAN; Lyndsey BOUVE; Hannah HOME; Megan ROSS; Lina PATEL; Bryce Walker; Astryd A. MENENDEZ; Sam Stephens; Nathan Lucas
Original assignee: Board Of Trustees Of The University Of Arkansas; Bioventures, Llc
Priority date: 2021-12-20
Filing date: 2022-12-19
Publication date: 2023-06-29

Abstract

The present disclosure pertains to air flow monitoring devices with a compartment having a first end with an opening; a second end with an opening; a cavity between the first end and the second end; a mouthpiece associated with the opening of the first end; a one-way valve associated with the opening of the first end and the mouthpiece; a sensor to monitor air flow through the cavity; and an electronic component electrically associated with the sensor to process air flow measured by the sensor and provide instructions to a user. The present disclosure also pertains to methods of monitoring exhalation in a user by actuating the device to instruct the user to exhale into the device while the sensor monitors air flow of the cavity during exhalation. The device may prompt the user to stop exhalation after a certain occurrence and then instruct the user to re- attempt the exhalation.

Description

AIR FLOW MONITORING DEVICE SUITABLE FOR PEDIATRIC USE

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims the benefit of U.S. Provisional Patent Application No. 63/291,846, filed on December 20, 2021. The entirety of the aforementioned application is incorporated herein by reference.

BACKGROUND

[0002] Current methods and devices for pulmonary function testing (PFT) have numerous limitations. For instance, many of the existing devices are overly complex, expensive, and not made for the pediatric population. Numerous embodiments of the present disclosure address the aforementioned limitations.

SUMMARY

[0003] In some embodiments, the present disclosure pertains to an air flow monitoring device. In some embodiments, the airflow monitoring device includes a compartment having a first end with an opening, a second end with an opening, and a cavity between the first end and the second end.

[0004] In some embodiments, the airflow monitoring devices of the present disclosure also include a mouthpiece associated with the opening of the first end; a valve associated with the opening of the first end and the mouthpiece, where the valve is operational to prevent backflow of air from the cavity of the compartment to outside of the first end; a sensor operational to monitor air flow through the cavity; and an electronic component electrically associated with the sensor, where the electronic component is operational to process the air flow measured by the sensor and provide instructions to a user of the air flow monitoring device.

[0005] The airflow monitoring devices of the present disclosure can include various sensors. For instance, in some embodiments, the sensor includes a barometric sensor. In some embodiments, the barometric sensor is operational to monitor air flow through the cavity by monitoring air pressure of the cavity and correlating the air pressure to air flow. [0006] In some embodiments, the sensor includes a thermistor. In some embodiments, the thermistor is operational to monitor air flow through the cavity by monitoring temperature of the cavity and correlating the temperature to air flow.

[0007] In some embodiments, the electronic component is at least partially positioned within a housing. In some embodiments, the housing is removably coupled to the compartment.

[0008] In some embodiments, the electronic component includes a microcontroller. In some embodiments, the electronic component also includes a power source operational for supplying power to the electronic component. In some embodiments, the power source includes a battery.

[0009] In some embodiments, the electronic component also includes indicator lights operational to provide visual instructions to the user. In some embodiments, the electronic component also includes an interactive screen operational to provide visual instructions to the user. Additionally, the electronic component may include a power actuator operational for actuating the electronic component.

[0010] In some embodiments, the air flow monitoring devices of the present disclosure may be suitable for use in monitoring exhalation in a user. Additional embodiments of the present disclosure pertain to methods of monitoring exhalation in a user by utilizing the airflow monitoring devices of the present disclosure. In some embodiments, such methods include actuating an electronic component of an air flow monitoring device of the present disclosure. The actuating initiates the transmission of instructions to the user to exhale into the device through the mouthpiece of the device. The sensor of the device monitors air flow of the device’s cavity during the exhalation.

[0011] In some embodiments, the air flow monitoring device prompts the user to stop exhalation after a certain occurrence. In some embodiments, the methods of the present disclosure also include a step of instructing the user to re-attempt the exhalation after the occurrence.

[0012] In some embodiments, the occurrence includes the passage of a period of time that begins when the cavity reaches an airflow above a set threshold and ends after the airflow is maintained for a set period of time. In some embodiments, the occurrence includes a reduction in airflow of the cavity below a set threshold. [0013] In some embodiments, the reduction in airflow is determined by the sensor of the device. For instance, in some embodiments, the sensor includes a barometric sensor that is operational to monitor air flow through the cavity by monitoring air pressure of the cavity and correlating the air pressure to air flow. In some embodiments, the sensor includes a thermistor that is operational to monitor air flow through the cavity by monitoring temperature of the cavity and correlating the temperature to air flow.

[0014] In some embodiments, the methods of the present disclosure may be utilized to monitor lung function. In some embodiments, the methods of the present disclosure may be utilized to monitor lung function in a user suffering from a lung function disorder. In some embodiments, the lung function disorder includes asthma, chronic obstructive pulmonary disease (COPD), pediatric lung function disorders, adult lung function disorders, cystic Fibrosis (CF), muscular dystrophy (MD), obstructive lung disease, restrictive lung disease, or combinations thereof. In some embodiments, the user is a pediatric patient.

BRIEF DESCRIPTION OF THE DRAWINGS

[0015] FIGS. 1A-1O provide various illustrations of an airflow monitoring device of the present disclosure, including planar views of the device (FIGS. 1A-1B), sectional views of the device and its components (FIGS. 1C-1D), a planar view of the device’s electronic component housing 26 (FIG. IE), a planar view of the device’s enclosure retainer 43 (FIG. IF), a planar view of the device’s compartment 11 (FIG. 1G), a planar view of the device’s valve 21 (FIG. 1H), a planar view of the valve’s retainer 22 (FIG. II), a planar view of the valve’s membrane 23 (FIG. 1J), a planar view of the valve’s seat 24 (FIG. IK), a planar view of the valve’s seat spacer 25 (FIG. IL), a planar view of the device’s mouthpiece adaptor 16 (FIG. IM), the electrical controls layout of the device (FIG. IN), and the power layout of the device (FIG. IO).

[0016] FIGS. 2A-2D provide various illustrations of an air flow monitoring device of the present disclosure, including a planar view of the air flow monitoring device (FIG. 2A), an expanded view of the electronic components of the air flow monitoring device (FIG. 2B), an alternative planar view of the airflow monitoring device (FIG. 2C), and a disassembled view of the airflow monitoring device with depictions of its electronic component (FIG. 2D). [0017] FIG. 3 illustrates a method of monitoring exhalation in a user by utilizing the air flow monitoring devices of the present disclosure.

DETAILED DESCRIPTION

[0018] It is to be understood that both the foregoing general description and the following detailed description are illustrative and explanatory, and are not restrictive of the subject matter, as claimed. In this application, the use of the singular includes the plural, the word “a” or “an” means “at least one”, and the use of “or” means “and/or”, unless specifically stated otherwise. Furthermore, the use of the term “including”, as well as other forms, such as “includes” and “included”, is not limiting. Also, terms such as “element” or “component” encompass both elements or components comprising one unit and elements or components that include more than one unit unless specifically stated otherwise.

[0019] The section headings used herein are for organizational purposes and are not to be construed as limiting the subject matter described. All documents, or portions of documents, cited in this application, including, but not limited to, patents, patent applications, articles, books, and treatises, are hereby expressly incorporated herein by reference in their entirety for any purpose. In the event that one or more of the incorporated literature and similar materials defines a term in a manner that contradicts the definition of that term in this application, this application controls.

[0020] The diagnosis of lung function disorders, including asthma and chronic obstructive pulmonary disease (COPD), can only be confirmed through pulmonary function testing (PFT). These tests are most often performed in facilities using spirometry. For this test to be completed, the patient must exhale for six seconds with no backflow of air. Many pediatric patients are unable to complete this test properly. As a result, the patients are sent home with a mouthpiece and nose-clip to practice. This is an ineffective method of practice, as there is no mechanism to monitor the patient’s progress, or whether they are practicing correctly.

[0021] Furthermore, existing portable and hand-held spirometry devices are overly complex, expensive, and unsuitable for the pediatric population. A few of the existing devices also compile data from the tests, but none are specific for practicing. [0022] As such, a need exists for improved devices for monitoring lung function. A particular need also exists for improved take-home training devices specifically for pediatric patients in preparation for spirometry pulmonary function testing. Numerous embodiments of the present disclosure address the aforementioned needs.

[0023] In some embodiments, the present disclosure pertains to air flow monitoring devices. By way of example and illustration, the air flow monitoring devices of the present disclosure may be represented by air flow monitoring device 10 in FIGS. 1A-1O. As illustrated in FIGS. 1A-1B, air flow monitoring device 10 may include a compartment 11 with a first end 12, a second end 13, and a cavity 14 between the first end 12 and the second end 13. In some embodiments, first end 12 also includes an opening. In some embodiments, second end 13 also includes an opening for the egress of airflow from the cavity.

[0024] As further illustrated in FIGS. 1A-1B, air flow monitoring device 10 may also include a mouthpiece 15 that is associated with the opening of first end 12. In some embodiments illustrated in FIGS. 1A-1B, air flow monitoring device 10 also includes a mouthpiece adaptor 16. In some embodiments illustrated in FIGS. 1A-1D, mouthpiece adaptor 16 is positioned between mouthpiece 15 and valve 21.

[0025] As further illustrated in FIGS. 1C-1D, air flow monitoring device 10 may include a valve 21 that is associated with the opening of first end 12 and mouthpiece 15. In some embodiments, valve 21 is operational to prevent backflow of air from cavity 14 of compartment 11 to outside of first end 12. In some embodiments further illustrated in FIGS. 1C-1D and 1H- 1L, valve 21 includes valve retainer 22, valve membrane 23, valve seat 24, and valve seat spacer 25. In some embodiments, the valves of the present disclosure are in the form of a one-way valve. In some embodiments, the valves of the present disclosure are in the form of a flexible flap.

[0026] Airflow monitoring device 10 may also include a sensor that is operational to monitor air flow through cavity 14. Additionally, air flow monitoring device 10 may include an electronic component 27 that is electrically associated with the sensor. In some embodiments, electronic component 27 is operational to process the air flow monitored by the sensor and provide instructions to a user of the air flow monitoring device. [0027] As illustrated in FIGS. 1A-1E, electronic component 27 may include an electronic board 28, a power actuator 19 operational for actuating the electronic component, and an optical light 20 operational to provide visual instructions to a user. Electronic component 27 may also include language actuator 18 for switching audio language from one language (e.g., English) to another language (e.g., Spanish). Additionally, electronic component 27 may at least be partially positioned in housing 26, which includes base 30, wall 43 and battery charging slot 29.

[0028] As further illustrated in FIGS. 1C-1D, air flow monitoring device 10 may also include a wall 17 within cavity 14 between first end 12 and second end 13. Wall 17 may also include at least one aperture for facilitating air flow from first end 12 to second end 13. In some embodiments, wall 17 may form a sub-compartment between first end 12 and second end 13. In some embodiments, wall 17 may be positioned at or near the second end.

[0029] The airflow monitoring devices of the present disclosure can include various structures and arrangements. For instance, by way of further example and illustration, the air flow monitoring devices of the present disclosure may also be represented by air flow monitoring device 50 in FIGS. 2A-2D. As illustrated in FIG. 2A, air flow monitoring device 50 may include a compartment 51 with a first end 52, a second end 53, and a cavity 54 between the first end 52 and the second end 53. First end 52 includes an opening. Second end 53 also includes an opening for the egress of airflow from cavity 54.

[0030] As further illustrated in FIG. 2A, air flow monitoring device 50 may also include a mouthpiece 55 that is associated with the opening of first end 52. Additionally, air flow monitoring device 50 may include a valve 56 that is associated with the opening of first end 52 and mouthpiece 55. Valve 56, which is in the form of a flap, is operational to prevent backflow of air from cavity 54 of compartment 51 to outside of first end 52.

[0031] Air flow monitoring device 50 may also include a sensor that is operational to monitor the air flow through cavity 54. Additionally, air flow monitoring device 50 may include an electronic component 57 that is electrically associated with the sensor. In some embodiments, electronic component 57 is operational to process the air flow monitored by the sensor and provide instructions to a user of the air flow monitoring device. [0032] Electronic component 57 may at least be partially positioned in lower housing 59 positioned within cavity 54 of compartment 51, and an upper housing 58 positioned on an outer surface of compartment 51. Upper housing 58 may include indicator lights A, B, and C that are operational to provide visual instructions to a user. Additionally, electronic component 57 may include power actuator D operational for actuating the electronic component.

[0033] The air flow monitoring devices of the present disclosure may include various structures. For instance, in some embodiments, the first end of the compartment is narrower than the second end. In some embodiments, the compartment is in the form of a cylinder.

[0034] The airflow monitoring devices of the present disclosure can include various sensors. For instance, in some embodiments, the sensor includes a barometric sensor. In some embodiments, the barometric sensor is operational to monitor air flow through a cavity by monitoring air pressure of the cavity and correlating the air pressure to air flow. In some embodiments, the sensor includes at least one thermistor. In some embodiments, the thermistor is operational to monitor air flow through the cavity by monitoring temperature of the cavity and correlating the temperature to air flow.

[0035] In some embodiments, the sensor includes a plurality of thermistors. For instance, in some embodiments, the sensor includes a second thermistor. In some embodiments, the second thermistor is operational within the device, but outside the airflow cavity, to monitor the ambient temperature. In some embodiments, the second thermistor is operational to provide calibration for the first thermistor.

[0036] The air flow monitoring devices of the present disclosure may include various electronic components. For instance, in some embodiments, the electronic component includes a microcontroller. In some embodiments, the electronic components of the present disclosure also include a power source operational for supplying power to the electronic component. In some embodiments, the power source includes a battery. [0037] In some embodiments, the mouthpiece of the air flow monitoring devices of the present disclosure includes a first end and a second end. In some embodiments, the first end of the mouthpiece is associated with the opening of the compartment. In some embodiments, the second end of the mouthpiece is narrower than the first end of the mouthpiece.

[0038] The valves of the air flow monitoring devices of the present disclosure may be associated with the air flow monitoring devices of the present disclosure in various manners. For instance, in some embodiments, the valve is coupled to the first end of the compartment. In some embodiments, the mouthpiece fits over the valve.

[0039] The air flow monitoring devices of the present disclosure may provide users with various instructions. For instance, in some embodiments, the instructions include audio instructions, visual instructions, motion-based instructions, or combinations thereof. In some embodiments, the instructions include visual instructions in the form of signals. In some embodiments, the instructions include motion-based instructions in the form of vibrations. In some embodiments, the instructions include audio instructions in the form of voice prompts.

[0040] The air flow monitoring devices of the present disclosure may also include various types of electronic components. For instance, in some embodiments, the electronic components of the present disclosure include a power actuator operational for actuating the electronic component. In some embodiments, the power actuator may be on a surface of a compartment.

[0041] In some embodiments, the electronic components of the present disclosure also include an interactive screen that is operational to provide visual instructions to a user. In some embodiments, the interactive screen may be in the form of an LED screen.

[0042] In some embodiments, the electronic components of the present disclosure also include a timer. In some embodiments, the timer may be utilized to monitor air flow time in a cavity after a user exhales into an air flow monitoring device.

[0043] The air flow monitoring devices of the present disclosure may be in various forms. For instance, in some embodiments, the air flow monitoring devices of the present disclosure may be in the form of a hand-held device. In some embodiments, the air flow monitoring devices of the present disclosure have a toy-like appearance for appealing to pediatric users. [0044] The air flow monitoring devices of the present disclosure can have numerous applications. For instance, in some embodiments, the air flow monitoring devices of the present disclosure are operational for monitoring lung function. In some embodiments, the air flow monitoring devices of the present disclosure are operational for monitoring lung function in a user suffering from a lung function disorder. In some embodiments, the lung function disorder includes, without limitation, asthma, chronic obstructive pulmonary disease (COPD), pediatric lung function disorders, adult lung function disorders, cystic Fibrosis (CF), muscular dystrophy (MD), obstructive lung disease, restrictive lung disease, or combinations thereof.

[0045] In some embodiments, the air flow monitoring devices of the present disclosure may be suitable for spirometry pulmonary function testing. In some embodiments, the air flow monitoring devices of the present disclosure may be suitable for pediatric use.

[0046] In some embodiments, the air flow monitoring devices of the present disclosure may be suitable for training a user to utilize a spirometry pulmonary function testing device. In some embodiments, the user is a pediatric patient.

[0047] Additional embodiments of the present disclosure pertain to methods of monitoring exhalation in a user. In some embodiments illustrated in FIG. 3, the methods of the present disclosure include: providing an air flow monitoring device of the present disclosure (step 70); actuating the electronic component of the air flow monitoring device (step 72) to initiate the transmission of instructions to the user to exhale into the air flow monitoring device through the mouthpiece (step 74) while the sensor monitors the airflow of the cavity during the exhalation (step 76). In some embodiments, the air flow monitoring device prompts the user to stop exhalation after a certain occurrence (step 78). In some embodiments, the methods of the present disclosure also include a step of instructing the user to re-attempt the exhalation (step 80).

[0048] The methods of the present disclosure may prompt a user to stop exhalation after various occurrences. For instance, in some embodiments, the occurrence includes a change in airflow of the cavity below a set threshold. In some embodiments, the change in airflow is determined by the sensor of the air flow monitoring device. [0049] In some embodiments, the occurrence includes the passage of a period of time. In some embodiments, the period of time begins when the cavity of the air flow monitoring device reaches an airflow above a set threshold and ends after the airflow is maintained for a set period of time. In some embodiments, the set period of time is at least 1 second, at least 2 seconds, at least 4 seconds, at least 5 seconds, at least 10 seconds, at least 15 seconds, or at least 20 seconds. In some embodiments, the set period of time is 6 seconds.

[0050] In some embodiments, the airflow in the cavity of the air flow monitoring device is monitored by the sensor of the air flow monitoring device. In some embodiments, the period of time is monitored by a timer associated with the air flow monitoring device.

[0051] In some embodiments, the sensor includes a barometric sensor operational to monitor air flow through the cavity by monitoring air pressure of the cavity and correlating the air pressure to air flow. In some embodiments, the sensor includes a thermistor operational to monitor air flow through the cavity by monitoring temperature of the cavity and correlating the temperature to air flow.

[0052] The methods of the present disclosure may instruct users to stop or start exhalation through various instructions. For instance, in some embodiments, the instructions include, without limitation, audio instructions, visual instructions, motion-based instructions, or combinations thereof.

[0053] In some embodiments, the instructions include visual instructions in the form of signals. In some embodiments, the instructions include motion-based instructions in the form of vibrations. In some embodiments, the instructions include audio instructions in the form of voice prompts.

[0054] The methods of the present disclosure may have various applications. For instance, in some embodiments, the methods of the present disclosure may be utilized to monitor lung function in a user. In some embodiments, the methods of the present disclosure may be utilized to monitor lung function in a user suffering from a lung function disorder. In some embodiments, the lung function disorder includes asthma, chronic obstructive pulmonary disease (COPD), pediatric lung function disorders, adult lung function disorders, cystic Fibrosis (CF), muscular dystrophy (MD), obstructive lung disease, restrictive lung disease, or combinations thereof.

[0055] In some embodiments, the methods of the present disclosure may be utilized for spirometry pulmonary function testing. In some embodiments, the methods of the present disclosure may be utilized for pediatric use.

[0056] In some embodiments, the methods of the present disclosure may be utilized for training a user to utilize a spirometry pulmonary function testing device. In some embodiments, the user is a pediatric patient.

[0057] Additional Embodiments

[0058] Reference will now be made to more specific embodiments of the present disclosure and experimental results that provide support for such embodiments. However, Applicant notes that the disclosure below is for illustrative purposes only and is not intended to limit the scope of the claimed subject matter in any way.

[0059] Example 1. Fabrication of a spirometry training tool

[0060] This Example describes the fabrication of a spirometry training tool illustrated in FIGS. 1A-1O, which is intended to assist users, principally children, with the typical requirement of constant exhalation for a prescribed period of time. The device generally consists of a mouthpiece 15, one-way valve 21, compartment 11, housing 26 and electronics board 28. [0061] A disposable mouthpiece 15 presses onto the proximal end 12 of compartment 11 and serves as the breath inlet. Airflow from the user’s exhalation is permitted to pass into the device through one-way valve 21 located immediately distal to mouthpiece 15. Retrograde flow is prevented by this valve, requiring the user to either unseal their lips from mouthpiece 15 or inhale through the nose to take a breath. Airflow travels through a constriction within compartment 11, formed by the underside of housing 26, and freely exits the distal end 13.

[0062] Detection of airflow through compartment 11 is accomplished by a thermistor which extends through the bottom of housing 26 and into the airstream. During testing, the resistance of this thermistor is continually monitored to determine whether the user failed to exhale for the full duration of the test. A second thermistor, located within the housing and away from the airstream, monitors ambient temperature and is used for calibration.

[0063] Instructions and testing indications are made by audio feedback from a speaker, located within the housing. An audible “ready, set, go” starting sequence initiates the test, while the elapsed time is called out as the numerals “one, two, three...”. Test success or failure are indicated by one of two jingles that play at the test’s conclusion.

[0064] Testing indications are additionally made through light cues, generated by an LED within the housing. The LED light is externalized through a light guide, extending through the wall of the compartment, and a terminating diffuser. During the audible “ready, set, go” cue, the light displays red, yellow and green colors. Upon failure or success of the test, a rapid blinking light in red or green respectively alerts the user.

[0065] Testing is initiated by the user by a power actuator 19, which is in the form of a push button. This push button is located within housing 26, but the finger pad extends through the wall of the compartment and is externally accessible. A language actuator 18 permits the user to select between different languages for the audio cues. This language actuator 18, which is in the form of a switch, is located within the housing, but the finger pad extends through the wall of the compartment and is externally accessible. [0066] Control of the speaker and optical light 20 as well as measurement from the buttons and thermistors is accomplished by an electronic board 28 housed within housing 26. The electronic board is programmed prior to patient enrollment and is, along with the rest of the housing, inaccessible to the patient. The electronic board and other electronic components are powered by a rechargeable battery within the enclosure.

[0067] The housing 26 and its contents insert into distal end 13 of compartment 13. It is locked into place by a bolt that passes through the enclosure and threads into the innermost face of the valve frame. Once secured, the head of the anchoring bolt is recessed inside the compartment, further discouraging removal by the patient.

[0068] FIG. IE provides an illustration of housing 26. In this example, housing 26 represents a three-dimensional printed PLA Material with a base 30 and an aperture 29. Housing 26 glues to enclosure retainer 43 with a CA glue.

[0069] FIG. IF provides an illustration of enclosure retainer 43, which contains aperture 31. In this Example, enclosure retainer 43 is laser cut from acrylic sheets. Housing 26 glues to upstream end of housing 26 with a CA glue. Enclosure retainer 27 anchors housing 26 by connecting via bolt to valve seat 24.

[0070] FIG. 1G illustrates compartment 11, which contains cavity 14 and apertures 32, 33 and 34. In this Example, compartment 11 is cut from off the shelf plastic tubes and glues to mouthpiece adapter 16 with a CA glue. Apertures 32, 33 and 34 are drilled for switch access and optic fiber 1 *4” ID, 1 *6” OD, and 2.5” Length.

[0071] FIG. 1H provides an illustration of valve 21. As illustrated in FIGS. 1C-1D, valve 21 includes valve retainer 22, valve membrane 23, valve seat 24, and valve seat spacer 25. In this example, valve 21 is in the form of a mechanical valve custom made from cut acrylic.

[0072] FIG. II provides an illustration of valve retainer 22, which includes aperture 37 and arms 35 and 36. In this example, valve retainer 22 is laser cut from acrylic sheets. Valve retainer 22 acts as a washer between valve membrane 23 and retention hardware in compartment 11. Arms 35 and 36 are spider- like to keep valve membrane 23 approximated to valve seat 24. [0073] FIG. 1J provides an illustration of valve membrane 23, which contains aperture 38. In this example, valve membrane 23 was laser cut or stamped from a 1/32” silicone sheet. The valve membrane helps ensure unidirectional air flow through the valve.

[0074] FIG. IK provides an illustration of valve seat 24, which contains apertures 39, 40, 41 and 42. In this example, valve seat 24 was laser cut from an acrylic sheet. Valve seat 24 forms the seat against which the valve membrane 23 seals when negative pressure is applied. Valve seat 24 also serves as the upstream anchor point for the housing 26 and enclosure retainer 43. In this example, valve seat 24 is bonded to valve seat spacer 25 with an acrylic solvent.

[0075] FIG. IL provides an illustration of valve seat spacer 25. In this example, valve seat spacer 25 is laser cut from an acrylic sheet. Valve seat spacer 25 provides separation between valve seat 24 and mouthpiece adapter 16. Valve 21, mouthpiece 15, and mouthpiece adaptor 16 are bonded to one another with acrylic solvents.

[0076] FIG. IM provides illustrations of mouthpiece adaptor 16. In this example, the mouthpiece adaptor 16 is 3D printed without a need for support material.

[0077] FIG. IN provides an electrical controls layout of the spirometry tool, including the thermistor. In this example, a microcontroller receives inputs from sensors and user-actuated buttons or switches. Additionally, the microcontroller controls and outputs signals to a speaker and multi-color LED. The microcontroller is programmed initially by a separate computer and programming thereafter resides on the microcontroller. This example additionally contains current-setting resistors, a transistor for power switching to the speaker, and user-actuated buttons or switches. The user- actuated portion of the buttons or switches extend through to the exterior of the device where they are accessible.

[0078] FIG. IO provides a power layout of the spirometry tool. In this example, a lithiumpolymer battery has its power level monitored by a battery charger. The battery charger receives voltage from the microcontroller whenever the microcontroller is connected to external USB. When necessary, the battery charger recharges the lithium polymer battery. When not connected to external USB, the microcontroller is powered by the lithium polymer battery. [0079] Example 2. Fabrication of a spirometry training tool

[0080] This Example describes the fabrication of an alternate spirometry training tool illustrated in FIGS. 2A-2D, which is intended to assist users, principally children, with the typical requirement of constant exhalation for a prescribed period of time. The device generally consists of a mouthpiece 55, one-way valve 56, compartment 51, and housing 57.

[0081] The device was printed in four different parts using a Formlab 3D resin printer and is composed of Gray V4 and Dental SG photopolymer resin. The four printed parts include the compartment 51, the lower electrical housing 59, the upper electrical housing 58, and the mouthpiece 55. The electrical components are fully housed on a two-sided printed circuit board (PCB) that is powered by a Cr2032 coin cell battery. The device begins with the power on pushpin key of the device which applies 3.3 volt (V) reset pin. Then initialization of the input/output (VO) pins is proceeded which initiates the red, yellow, and green light-emitting diode (LED) lights A, B, and C to indicate to the user that the device is on. This will tell the user to start the test with the guidance of audio instruction.

[0082] Since the pressure inside the tube of the device will change when someone is blowing into it, a barometric sensor will be used to measure airflow. Once the barometric sensor reads a change determined by a set threshold in pressure, it will report its findings to an on-board microcontroller. Once the pressure reading rises above the threshold value, a timer will start. If at any point the pressure falls below the threshold value, the timer will stop. The device will be able to measure pressure changes from 300 to 1100 hecto Pascals (hPa). These barometric pressure limits result in the device being able to be use accurately 300 meters (m) below sea level and 9000 m above sea level. Because the barometer measures differential pressure, the device can be used accurately in various locations and elevations. It should be noted that the pressure is taken as soon as the device turns on, and only takes a time between 1 and 100 milliseconds (ms) to measure the pressure, which is long before a participant is blowing into the device. The barometer will be able to measure pressure differences of 1 hPa. The microcontroller will also control the LED lights and speaker on the device, which will be activated at precise times outlined in the project overview section. The device will be able to operate in a temperature range of -30 °F to 120 °F, which ensures that the device is able to be left in fairly extreme conditions and still function properly. [0083] The device will be powered by a Cr2032 3 V coin cell battery. The tolerance of these types of batteries can go up to 0.05%, which in this case means this device will have a maximum input voltage of 3.15 V. These batteries cut off at 2 V and therefore the device will be able to function properly until reaching the 2 V minimum. Therefore, the voltage range of the device will be from 3.15 V to 2 V. Typically, these batteries have a capacity of around 220 milliampere per hour (mAh). With this design, it is expected that the typical current consumption in the device will be approximately 66 milliampere (mA) when on.

[0084] The PCB in this example is about 3”xl,” which will be enclosed in a protective electrical housing, and will be removable so that the device can be washed. There will be a timer, audio unit, barometer, and 3 LED lights to detect that a user is taking the test and send feedback to them based on the result of the test. In total, the device’s tube will be about 4 inches long with a diameter of 1.5 inches and will feature a mouthpiece that is 1.5 inches long.

[0085] The PCB has three lights that extend through the roof of the electrical housing to the exterior of the device. The top of the electrical housing also has a mechanical arm that extends from the exterior power button to the power button on the surface of PCB . The PCB also has a barometer on the bottom of the PCB to register pressure change. The PCB attaches to the raised bed of the lower electrical housing and then the lower electric housing screws into the upper electrical housing piece using four two-gauge screws. The electrical housing then slides into the outer tube on a track system and is locked into place using a spring-loaded keyhole mechanism. A one-way respiratory valve fits into the narrow end of the compartment. The mouthpiece fits over the respiratory valve and is secured using a strong adhesive.

[0086] When a patient is ready to use the device, they will hold it in either hand, whichever is more comfortable. The patient will have to hold the power button down for 3 seconds to trigger the start of the test. The patient will receive a “Ready, Set, Go” audio prompt corresponding to a red, yellow, and green LED light display that mimics a traffic light. This will prompt the patient to start blowing air when the green light and “Go” audio are activated. [0087] The air from the patient will travel through the one-way respiratory valve into the tube and the barometer will detect a change in pressure in the device. If there is some malfunction in the testing then the red LED light will flash and the patient will be prompted to attempt the test again. These errors in testing include drop in pressure that can be triggered by backflow that shuts the valve, or the patient not being able to exert airflow for the entirety of the test. It must be noted that air flow may still be detected even if the patient does not have a complete seal around the mouthpiece of the device. If the test is carried out for the full 6 seconds, the patient will receive an auditory reward in the form of a jingle.

[0088] A prototype has been developed that incorporates most of the mechanisms previously described. The current prototype was printed with Gray V4 resin and Dental SG resin in four parts. The sliding mechanism and removeable electronic housing has been fully tested, along with the keyhole locking mechanism. The electronic components are fully tested and included in the final prototype except for the voice audio recordings. Instead, there is a beep after every second and to mark the "Ready, Set, Go" beginning audio.

[0089] A prototype has been developed that incorporates most of the mechanisms previously described. The current prototype was printed with Gray V4 resin and Dental SG resin in four parts. The sliding mechanism and removeable electronic housing has been fully tested, along with the keyhole locking mechanism. The electronic components are fully tested and included in the final prototype except for the voice audio recordings. Instead, there is a beep after every second and to mark the "Ready, Set, Go" beginning audio prompt.

[0090] This device may also be further developed to be Bluetooth compatible and able to communicate with handheld electronics such as a phone or tablet. An app could also be developed to communicate with the device and show prompting graphics or progress tracking.

[0091] It has also been discussed in further design development to turn the 3D model into a rocket ship, or other familiar design, that would make the device look more child friendly, and more like a toy. [0092] Without further elaboration, it is believed that one skilled in the art can, using the description herein, utilize the present disclosure to its fullest extent. The embodiments described herein are to be construed as illustrative and not as constraining the remainder of the disclosure in any way whatsoever. While the embodiments have been shown and described, many variations and modifications thereof can be made by one skilled in the art without departing from the spirit and teachings of the invention. Accordingly, the scope of protection is not limited by the description set out above, but is only limited by the claims, including all equivalents of the subject matter of the claims. The disclosures of all patents, patent applications and publications cited herein are hereby incorporated herein by reference, to the extent that they provide procedural or other details consistent with and supplementary to those set forth herein.

Claims

CLAIMS:

1. An air flow monitoring device comprising: a compartment, wherein the compartment comprises: a first end, a second end, and a cavity between the first end and the second end, wherein the first end comprises an opening; a mouthpiece associated with the opening of the first end, a valve associated with the opening of the first end and the mouthpiece, wherein the valve is operational to prevent backflow of air from the cavity of the compartment to outside of the first end; a sensor operational to monitor air flow through the cavity; and an electronic component electrically associated with the sensor, wherein the electronic component is operational to process the air flow measured by the sensor and provide instructions to a user of the air flow monitoring device.

2. The airflow monitoring device of claim 1, wherein the sensor comprises a barometric sensor, wherein the barometric sensor is operational to monitor air flow through the cavity by monitoring air pressure of the cavity and correlating the air pressure to air flow.

3. The airflow monitoring device of claim 1, wherein the sensor comprises a thermistor, wherein the thermistor is operational to monitor air flow through the cavity by monitoring temperature of the cavity and correlating the temperature to air flow.

4. The airflow monitoring device of claim 1, wherein the second end comprises an opening for the egress of airflow from the cavity.

5. The airflow monitoring device of claim 1, wherein the device further comprises a mouthpiece adaptor, wherein the mouthpiece adaptor is positioned between the mouthpiece and the valve.

6. The airflow monitoring device of claim 1, wherein the valve is a one-way valve.

7. The air flow monitoring device of claim 1, wherein the electronic component is at least partially positioned within a housing, wherein the housing is removably coupled to the compartment.

8. The air flow monitoring device of claim 1, wherein the electronic component comprises a microcontroller.

9. The air flow monitoring device of claim 1, wherein the electronic component comprises a power source operational for supplying power to the electronic component.

10. The air flow monitoring device of claim 1, wherein the electronic component comprises indicator lights operational to provide visual instructions to the user.

11. The air flow monitoring device of claim 1, wherein the electronic component comprises a power actuator operational for actuating the electronic component.

12. The air flow monitoring device of claim 1, wherein the air flow monitoring device is in the form of a hand-held device.

13. A method of monitoring exhalation in a user, said method comprising: actuating an electronic component of an air flow monitoring device of any one of claims 1-12; wherein the actuating initiates the transmission of instructions to the user to exhale into the air flow monitoring device through the mouthpiece of the airflow monitoring device, and wherein the sensor of the airflow monitoring device monitors air flow of the cavity of the airflow monitoring device during the exhalation.

14. The method of claim 13, further comprising a step of providing the air flow monitoring device of any one of claims 1-12.

15. The method of claim 13, wherein the air flow monitoring device prompts the user to stop exhalation after a certain occurrence.

16. The method of claim 15, wherein the occurrence comprises a reduction in airflow of the cavity below a set threshold, and wherein the reduction in airflow is determined by the sensor.

17. The method of claim 15, wherein the occurrence comprises the passage of a period of time, wherein the period of time begins when the cavity reaches an airflow above a set threshold and ends after the airflow is maintained for a set period of time.

18. The method of claim 13, wherein the sensor comprises a barometric sensor operational to monitor air flow through the cavity by monitoring air pressure of the cavity and correlating the air pressure to air flow.

19. The method of claim 13, wherein the sensor comprises a thermistor operational to monitor air flow through the cavity by monitoring temperature of the cavity and correlating the temperature to air flow.

20. The method of claim 13, further comprising a step of instructing the user to re-attempt the exhalation.

21. The method of claim 13, wherein the instructions comprise audio instructions, visual instructions, motion-based instructions, or combinations thereof.

22. The method of claim 13, wherein the method is utilized for monitoring lung function in the user.

23. The method of claim 22, wherein the user is suffering from a lung function disorder.

24. The method of claim 23, wherein the lung function disorder comprises asthma, chronic obstructive pulmonary disease (COPD), pediatric lung function disorders, adult lung function disorders, cystic Fibrosis (CF), muscular dystrophy (MD), obstructive lung disease, restrictive lung disease, or combinations thereof.

25. The method of claim 13, wherein the air flow monitoring device is used to train a user to utilize a spirometry pulmonary function testing device.

26. The method of claim 13, wherein the user is a pediatric patient.

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