Oscillating positive expiratory pressure device

Abstract

To provide a respiratory therapy device having a diagnostic feedback array and a method for a user of the respiratory therapy device.SOLUTION: A smart oscillating positive expiratory pressure (OPEP) device according to the present invention provides a user (patient or caregiver) with feedback regarding a frequency, mean pressure, and amplitude of pressure oscillations generated during a treatment session. The OPEP device according to the present invention comprises: a mouthpiece defining a longitudinal axis and having an end port; a housing connected to the mouthpiece and having a top surface, where at least a portion of the top surface is longitudinally spaced from the end port and defines a viewing surface adapted to be visible to a user having the end port disposed in a mouth of the user; and a feedback array disposed on the viewing surface, where the feedback array extends diagonally across the viewing surface.SELECTED DRAWING: Figure 86A

Description

Technical Field

[0001] Embodiments disclosed herein generally relate to a smart oscillating positive expiratory pressure device and methods of using and assembling the same.

[0002]

Cross - Reference to Related Applications

Background Art

[0003] Chronic obstructive pulmonary disease (COPD) and cystic fibrosis (CF) can cause increased work of breathing, resulting in shortness of breath, respiratory muscle fatigue, and general discomfort. Oscillating positive expiratory pressure (OPEP) therapy may be used as a technique to remove excess mucus from the lungs of COPD and CF patients without using drugs. OPEP may also be used post - operatively to reduce the risk of post - operative pulmonary complications. Typically, OPEP devices provide minimal feedback to the user or caregiver regarding the performance and / or effectiveness of the device during a treatment session. In addition, while hospital systems are responsible for COPD patients who do not return to the hospital within 30 days, the majority (60%) of COPD patients do not comply with the prescribed treatment. Furthermore, OPEP devices typically do not provide feedback regarding treatment compliance, progress tracking, or proper use techniques.

Summary of the Invention

[0004] Briefly speaking, in one embodiment, the smart OPEP device provides feedback to the user (patient or caregiver) regarding the frequency, mean pressure, and amplitude of the pressure oscillations that occur during a treatment session. Additionally, by archiving and analyzing data and information collected regarding the performance of the OPEP device, an overview of the user's progress can be provided that is available to healthcare providers and insurers, for example, to monitor treatment compliance. Given the patient's specific data, trends over time can be monitored. Performance targets and / or performance limits can be set to help the user achieve the correct technique, and the effectiveness of the treatment can be evaluated by investigating the patient's quality of life and correlating this to performance. Additionally, while the performance characteristics are being measured, the user can set up the device, and the user can be motivated by various feedbacks including the coefficient of the breathing rate or by playing a game based on the measured values.

[0005] In one embodiment, a smart accessory for a vibrating expiratory positive pressure device includes an adapter having a first end that is preferably coupled to the vibrating expiratory positive pressure device, a second end that is located on the opposite side of the first end and is preferably coupled to a mouthpiece, a flow channel configured between the first end and the second end, and a port that communicates with the flow channel between the first end and the second end. A flexible membrane is disposed across the port, and the flexible membrane has a first side in fluid communication with the flow channel and an opposite second side that partially defines a chamber. A pressure sensor and / or a microthermal flow sensor is in fluid communication with the chamber. A control module is coupled to the adapter, and the control module is operative to collect data from the pressure sensor and / or the microthermal flow sensor.

[0006] In one aspect, the adapter can be disconnected from the oscillating expiratory positive pressure device, and the control module can be disconnected from the adapter and placed aside. For example, a tether maintains the connection between the flexible membrane and the adapter. In one embodiment, the flexible membrane can move between a first position where the membrane is disposed across the port and partially defines the chamber and a second position where the membrane is not disposed across the port. The adapter can be cleaned with the membrane attached, and then the membrane is moved to the first position and the control module is reconnected to the adapter.

[0007] In another aspect, an oscillating expiratory positive pressure device as an embodiment has a mouthpiece that defines a longitudinal axis and has an end port, and a housing that is connected to the mouthpiece and has a top surface. At least a portion of the top surface is longitudinally spaced from the end port and forms a visual plane that is visible to the user with the end port in their mouth. It further has a feedback array disposed on the visual surface, and this feedback array extends diagonally across the visual surface. A direction indicator (directional indicator) and a descriptor representing an amount (quantity descriptor) may also be attached to the visual surface.

[0008] It should be understood that the feedback array, the direction indicator, and the quantity descriptor may also be provided in other respiratory care systems, and such other respiratory care systems include, for example, various drug delivery devices, holding chambers, dry powder inhalers, and / or nebulizers, whether directly attached to or connected to a module housing attached to its housing component, but are not limited thereto.

[0009] In another aspect, a method of using a vibratory expiratory positive airway pressure device as an embodiment includes the step of exhaling through an end port into a mouthpiece defining a longitudinal axis, thereby generating an exhalation flow rate and pressure, and the step of visually observing a feedback array provided on the top surface of a housing coupled to the mouthpiece, the feedback array extending diagonally across a visual surface, and the method further includes the step of illuminating at least a portion of the feedback array to indicate whether the exhalation flow rate or pressure is within a predetermined tolerance range or outside the predetermined tolerance range. A similar method can be utilized for other respiratory therapy devices, for example, during an inhalation cycle when using a holding chamber with a valve, a dry powder inhaler, and / or a nebulizer.

[0010] By providing user feedback during treatment, user engagement is ensured, thereby improving overall treatment compliance. Due to the diagonal orientation of the feedback array, the user can view the progress in a lighting sequence from low to high or from the middle to the outside (from left to right or from right to left). Due to the diagonal alignment of the feedback array, the user can easily view the feedback array in their peripheral vision even when performing other tasks, for example, when watching TV. The diagonal alignment along the top surface provides high visibility and eliminates the need to project the lights overly far from the top surface, thereby maintaining the size of the respiratory therapy device in a compact state as much as possible. Furthermore, the sequence and color arrangement of the lights are easy to understand and provide an attractive interface for the user.

[0011] This embodiment will be best understood with reference to the following detailed description taken in conjunction with the accompanying drawings, which accompany it for other purposes and other advantages.

Brief Description of the Drawings

[0012]

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DETAILED DESCRIPTION OF THE INVENTION

[0013] As used herein, the term "plurality" should be understood to mean two or more. The term "coupled" means "connected" or "engaged," whether directly or indirectly, for example, using an intervening member, and such term does not require that the "engagement" be in a fixed or permanent state, although the engagement may be fixed or permanent. It should be understood that terms represented by numbers such as "first," "second," "third," etc. used herein do not mean any particular order or sequence of components. It should be understood that the terms "user" and "patient" as used herein mean any user, including children, youths, or adults, and / or animals.

[0014] The term "smart" means features conforming to a general format having an input as the place where information enters the system, an analysis as the means by which the system acts on or modifies the information, and an output as the place where new information exits the system. The phrase "performance characteristics" means measurements that quantify how well an instrument functions, such as frequency or amplitude. Frequency is defined as the number of vibrations per second, but during typical OPEP operations, the vibration speed may not be constant. Therefore, frequency may be defined as the reciprocal of the time between vibrations (1 / T), measured in Hz. This second definition calculates the frequency of each vibration and then averages it over a period of time. The maximum pressure is typically the maximum pressure for each vibration, measured in cmH2O. The minimum pressure is typically the minimum pressure for each vibration, measured in cmH2O. The higher pressure is the average value of the maximum pressure over a given period, for example, over one second. The lower pressure is the average value of the minimum pressure over a given period, for example, over one second. The amplitude is the difference between the higher pressure and the lower pressure. The average pressure is the average value of the higher pressure and the lower pressure. The true average pressure is the average value of the entire pressure wave over a given period. The true average pressure is typically lower than the average pressure, because the typical pressure wave generated is not uniform, i.e., it is biased towards the minimum pressure.

[0015] Referring to FIG. 1, an OPEP pressure wave with various performance characteristics is shown. FIG. 2 shows in block diagram form an OPEP device shown as a dashed box surrounding internal components with smart features. One exemplary OPEP device 2 is the Aerobika® OPEP device shown in FIGS. 4, 24, 27 - 30, 47, 48, and FIGS. 86A and 86B available from Monaghan Medical Corporation, located in Pittsburgh, New York. Various OPEP devices and structures are further disclosed in U.S. Patent No. 8,985,111, issued March 24, 2015 (Title of the Invention: Oscillating Positive Expiratory Pressure Device), U.S. Patent No. 8,539,951, issued September 24, 2013 (Title of the Invention: Oscillating Positive Expiratory Pressure Device), U.S. Patent No. 9,220,855, issued December 29, 2015 (Title of the Invention: Oscillating Positive Expiratory Pressure Device), U.S. Patent Application Publication No. 2012 / 0304988, published December 6, 2012 (Title of the Invention: Oscillating Positive Expiratory Pressure Device), U.S. Patent Application Publication No. 2015 / 0297848, published October 22, 2015 (Title of the Invention: Oscillating Positive Expiratory Pressure Device), and U.S. Patent Application Publication No. 2015 / 0053209, published February 26, 2015 (Title of the Invention: Oscillating Positive Expiratory Pressure Device), which are hereby incorporated by reference in their entirety and made a part of this specification. It should be understood that other OPEP devices may include other components that generate pressure oscillations.

[0016] Referring to FIGS. 47, 48, 86A and 86B, a user, e.g., a patient, interacts with the OPEP device 2 via the mouthpiece 4. The OPEP device has a housing 6 that surrounds a mouthpiece chamber 48, chambers 14a, 14b, a chamber inlet 16 in communication with the mouthpiece, and one or more chamber outlets 18. Typically, with the OPEP device, a user can inhale and exhale, although there are some that only allow exhalation into the device. The housing 6 has a front section 8, a rear section 10, and an inner casing 12, which are separable so as to be able to periodically access, clean, or reconfigure the components housed therein as necessary to maintain ideal operating conditions.

[0017] The OPEP device 2 further has an inhalation port 20, a one-way valve 22, an adjustment mechanism 24, a restrictor member 26, a vane 28, and a variable nozzle 30 or vane assembly. As understood from FIGS. 47 and 48, the inner casing 12 is configured to fit within the housing 6 between the front section 8 and the rear section 10, and such inner casing partially defines chambers 14a, 14b that include a first chamber and a second chamber. First and second chamber outlets 18 are formed within the inner casing. The OPEP device preferably has an adjustment mechanism 24 that includes an actuator 25 adapted to vary the relative position of the chamber inlet 16. It is advantageous that both the frequency and amplitude of the OPEP therapy provided by the OPEP device 2 can be adjusted without the user opening the housing and without disassembling the components of the OPEP device. For example, the OPEP device preferably has a plurality, e.g., five, set values including high, medium, and low.

[0018] The OPEP device 2 may be adapted to be used in combination with other interfaces or additional interfaces, such as an aerosol (sometimes referred to as an aerosol) delivery device. In this regard, the OPEP device 2 includes an inhalation port 20 in fluid communication with the mouthpiece 4. As described above, the inhalation port may preferably have a separate one-way valve 22, which enables the user of the OPEP device 2 to inhale ambient air through the one-way valve 22 and exhale through the chamber inlet 16 without removing the mouthpiece 4 of the OPEP device 2 between the inhalation period and the exhalation period. Additionally, the above-mentioned commercially available aerosol delivery device may preferably be connected to the inhalation port 20 to enable simultaneous use of aerosol therapy (during inhalation) and OPEP therapy (during exhalation).

[0019] The exhalation flow path 40 begins at the mouthpiece 4 and is directed towards the chamber inlet 16 through the mouthpiece chamber 48. During operation, the exhalation flow path may or may not be blocked by a restrictor member 26 or a valve assembly preferably including a valve seat and a butterfly valve. After passing through the chamber inlet 16, the exhalation flow path 40 enters the first chamber 14a and turns 180° towards the variable nozzle 30. After passing through the orifice of the variable nozzle, the exhalation flow path enters the second chamber 14b. Within the second chamber 14b, the exhalation flow path 40 may preferably exit the second chamber 14b and finally exit the housing 6 through at least one of the chamber outlets 18. It should be understood that the exhalation flow path 40 shown by the dashed line is exemplary, and the air exhaled within the OPEP device 2 can flow along many directions or follow many paths when it moves from the mouthpiece 4 to the outlet 18.

[0020] Referring to FIGS. 53 to 56, an adapter 400 and a user interface / control module 408 as a first embodiment are shown. Generally, the adapter 400 has a main body 402, a conduit 404 extending from the main body 402, and a plug 406 positioned along and inserted into the conduit 404. The user interface / control module 408 may preferably include a pressure measuring instrument positioned at the outlet 403 of the conduit 404.

[0021] The main body 402 may be dimensioned and shaped to be integratable with an existing OPEP device 2 as shown, for example, in FIGS. 51, 55 and 59, or the mouthpiece 4 of the OPEP device 2. For example, the main body 402 may preferably have 22 mm ISO male / female conical connectors 410, 412 dimensioned and shaped to be connected to a port 414 provided in the OPEP device 2 and an insertion portion 416 of the mouthpiece 4, respectively. To explain the operating principle, the mouthpiece 4 is detached from the OPEP device 2 and the adapter is placed or coupled between the mouthpiece and the OPEP device. It should be understood that the adapter may be coupled to other components of the OPEP, such as the inhalation port 20.

[0022] The conduit 404 extends from the main body 402 and is configured to transmit pressure from within the OPEP device 2 to the user interface / control module 408. The inlet 405 can transmit the pressure within the main body 402 to the conduit 404. As shown, the conduit 404 extends away from the main body 402 and then slopes parallel to the OPEP device 2, thereby maintaining the portability and ergonomic characteristics of the OPEP device 2 and eliminating the need for long tubing or additional fittings.

[0023] The user interface / control module 408 is positioned at the outlet 403 of the conduit 404. However, it should be understood that a portion of the conduit 404 may extend into a passage within the user interface / control module 408 or into other pressure measuring instruments. Preferably, the user interface / control module 408 may have one or more of numerical markings, color markings, shape markings, or other visual markings, or one or more of voice or other auditory markings, or a combination of one or more of each of visual and auditory markings. With respect to one of the illustrated exemplary embodiments, the user interface / control module 408 includes a visual display, such as an array of LED lights 150 and a display screen 420, and this visual display may display various data as described further below. Preferably, the user interface / control module 408 is positioned relative to the respiratory therapy device such that the display and markings are visible to the user during treatment. As shown in the exemplary embodiments of FIGS. 51 and 55, the user interface / control module 408 is positioned relative to the respiratory therapy device in the form of the OPEP device 2 such that the visual displays 418, 420 are positioned adjacent to the top of the device and are visible to the user of the OPEP device 2 during treatment. Referring to FIG. 59, the user interface / control module 408 is positioned along the side of the OPEP device 2, but the visual display 418 faces the user.

[0024] The plug 406 can be inserted into and / or along the conduit 404 by press fitting at a location where the conduit 404 is inclined with the OPEP device 2 arranged side by side. In one embodiment, the plug cannot be removed, but this plug is preferably made of a self-sealing material, such as a silicone material, so that a needle or other similar device can be inserted or removed for cleaning purposes while maintaining the seal. In another embodiment, the plug may be periodically removed for cleaning of the adapter 400. As shown in FIG. 52B, the plug 406 has a notch 409 that can be aligned with a passage 410 provided in the conduit 404. When the plug 406 is inserted into the conduit 404 and the notch 409 is partially or completely aligned with the passage 410, a pressure stabilization orifice 407 is formed in the conduit 404. The pressure stabilization orifice 407 is configured to attenuate the vibration of the pressure transmitted from the OPEP device 2 to the user interface / control module 408.

[0025] The dimensions and shape of the pressure stabilization orifice 407 may preferably be selectively adjustable by rotating the plug 406 relative to the passage 404, thereby increasing or decreasing the attenuation amount. Although the pressure stabilization orifice 407 is shown as adjustable, it should be understood that the dimensions and shape of the pressure stabilization orifice 407 may be fixed. Further, it should be understood that the pressure stabilization orifice 407 may be positioned anywhere along the conduit 404 between the body 402 and the user interface / control module 408. However, in order for the pressure stabilization orifice 407 to effectively attenuate the vibration of the pressure transmitted from the OPEP device 2 to the user interface / control module 408, the cross-sectional area of the pressure stabilization orifice 407 should be smaller than the cross-sectional area of the conduit 404 along the entire length of the conduit 404. In this embodiment, the pressure stabilization orifice 407 has a diameter of 0.5 mm to 1.5 mm or a cross-sectional area of 0.196 mm 2 ~1.767 mm 2 . Preferably, the pressure stabilization orifice 407 has a diameter of 0.6 mm to 0.9 mm or a cross-sectional area of 0.283 mm2 ~0.636 mm 2 has a cross-sectional area of.

[0026] Referring to FIGS. 66A, 66B, 68 - 74B, 79 - 83, and FIGS. 86A and 96B, adapters 600, 900 and user interface / control modules 608, 908 are shown as another embodiment. Generally, adapters 600, 900 have a T-connector 620 with a cylindrical tube 622 that defines a flow channel 624. This tube has a first and a second end 626, 628, each configured as a tubular portion, and a port 630 that communicates with the flow channel between the first and the second ends. The first end 626 preferably has an outer diameter smaller than that of the second end, and this first end is shaped and dimensioned to be received within the tubular portion 632 of the OPEP, and the second end 628 is shaped and dimensioned to receive the tubular portion 634 of the mouthpiece 4. The port 630 has a rim portion 638 with a cylindrical body 636 and an upper face 640. A cylindrical groove 642 is formed in this face. The rim portion further includes a peripheral groove 644 that extends circumferentially along the periphery of the cylindrical body. A plurality of tabs 646 extend radially outward from the rim portion to facilitate a sliding engagement with the control module 608, and these tabs have a tapered leading edge 648 or ramp at the bottom. A through-opening 650 extends through the rim portion adjacent to one side of the adapter as shown in FIG. 76B.

[0027] The flexible membrane 660 has an annular rim 662 with an upper flat face 664 and a downwardly extending raised strip 668. The raised strip is shaped and dimensioned to be received within the circumferential groove 642 of the port and make an airtight (air-impermeable) engagement with this circumferential groove. The membrane 660 further has an annular hinge portion / bellow 670 or a thin J-shaped wall connected to a central cylindrical body portion 672. This membrane is preferably made of silicone rubber, such as Silopren silicone rubber available from Mometive. The body 672 has a thickness of, for example, 2.5 mm, and as a result, this body has sufficient mass relative to the bellow portion with a thickness of 0.3 mm, thereby providing good feedback to the control module. A tether 678 extends downward from the rim at a location spaced from the wall. This tether has a tapered nose portion 680 and an annular catch 682 with a shoulder. The tapered nose portion facilitates insertion into the opening 650, and the tether is pulled through the opening 650 until the shoulder of the catch engages the underside of the rim. The membrane 660 can move between a first engagement position where the raised strip 668 is inserted into the groove 642 and a second disengagement position where the raised strip is removed from the groove, for example, to enable cleaning or rinsing of the underside of the membrane and the interior of the T-connector. The tether 678 maintains the connection state between the membrane and the T-connector while the membrane is being moved between the first and second positions. The bottom side portion 674 of the membrane is in fluid communication with the flow channel 624 of the T-connector, and the opposite top side portion 676 partially defines a chamber 684.

[0028] Referring to FIGS. 66A, 66B, 68 - 74B, 79 - 84, and FIGS. 86A and 86B, control modules 608, 908 include housings 700, 910 with upper and lower casings 702, 704, 912, 914. Lower casings 702, 912 have chamber portions 706 located above the top side portion 676 of the membrane, and this top side portion and chamber portion define chamber 684. Chamber portion 706 has an overall circular or cylindrical shape and has a top wall 708 and a first circumferential wall 710 extending downward from this top wall. The top wall and the first circumferential wall partially define the chamber. A second circumferential wall 712 is disposed radially outward of the first wall and is connected to this first wall, and web portion 714 has a plurality of openings. A plurality of corresponding tabs 716 (shown in FIG. 71) extend radially inward from the bottom edge of the second wall, and space 718 is defined between the tabs. To explain the operating principle, housing 700 is placed over port 630 and membrane 660 with port tab 638 aligned with space 718. Housings 700, 910 are pressed against membrane 660 and rotated, as a result of which tabs 716 are biased by port tab 638 (shown in a state where five are provided for each), whereby when rib / raised strip 668 is pushed into groove 642, the bottom of web 714 is pressed against the top surface of membrane rim 662, thereby forming an airtight seal and forming internal chamber 684 between the membrane and the chamber portion of the housing. Control modules 608, 908 can be disconnected in the reverse manner, by rotating the control module relative to the port, and finally aligning tab 638 with space 718, and then it is advisable to axially separate these two components from each other. After separation, membrane 660 should also be moved away from the port, thereby enabling cleaning / rinsing of the membrane and T - connector while remaining connected to the T - connector via the tether.

[0029] The chamber portion further has an annular flange (Figure 71) that extends downward from the top wall and is disposed to cover the membrane or a moving / stopping member 720. The annular flange does not extend over 360°, and instead has a mouse portion or an opening positioned adjacent to the sensor port 724, such that air located within the boundary of the annular flange volume portion can escape to other parts of the chamber, for example, when the membrane engages the stopping member. The stopping member 720 is positioned at a distance from the top side portion 676 of its central body portion. The stopping member restricts upward movement of the central body portion during use. The lower casing 704 extends longitudinally over the top of the OPEP device. Vent holes 722 may be formed in the bottom wall of the lower casing to allow cooling of electronic components housed within the lower casing.

[0030] Port 724 is in fluid communication with the internal chamber. In one embodiment, a pressure sensor 730 is coupled to the port, for example, by pressing this pressure sensor against a seal 728, such as an O-ring, and the input portion 726 of the pressure sensor is in fluid communication with the internal chamber. In one embodiment, the upper casings 702, 914 are releasably coupled to the lower casings 704, 912, for example, by fastening portions 732, and the upper casing presses the sensor 730 against the seal. Circuit boards 740, 940 and a battery 742 are housed together with the pressure sensor 730 in the lower and / or upper casings, which define an internal space within the housing. The user interface / control modules 608, 908 include a visual display, for example, an array (one or more) of LED lights 750, a micro USB port 422, an SD card port 424, and a switch (on / off) 430. In the embodiments of FIGS. 79-83, the control module includes an accelerometer 930 disposed on and incorporated into the circuit board 940. A suitable accelerometer is, for example, the MEMS accelerometer part number MMA8452Q available from NXP Semiconductor. The accelerometer can be used instead of or in combination with the switch 430. Preferably, the user interface / control module 608 is positioned relative to the respiratory therapy device such that the display and markings are visible to the user or caregiver during treatment.

[0031] Referring to FIGS. 86A and 86B and FIG. 87, a vibrating expiratory positive pressure device is shown in a state including a mouthpiece 4, a tube 620, and a port 20 that define a longitudinal axis 901. The mouthpiece 4 includes an end port 903, and this end port is placed in the user's mouth at the use position. The adapter 900 includes a control module 908 with a housing 910. This adapter is connected to the mouthpiece 4, and the upper casing 912 of the housing 910 has a top surface 905. At least a part of the top surface 905, in the embodiments of FIGS. 86A and 86B, the entire top surface is longitudinally spaced from the end port 903 in the longitudinal direction 907. The top surface 905 defines a visual surface 911 that is visible to the user's eyes when the end port 903 is placed in the user's mouth as shown in FIGS. 86A and 86B. The visual surface may be flat or curved. A feedback array 909 is provided or arranged on the visual surface 911. The feedback array 909 extends diagonally across the visual surface 911, which means that this feedback array extends in the longitudinal direction 907 and also in the lateral (left - right) direction 913. In one embodiment, the feedback array 909 is substantially linear and extends along an axis 915 between opposite corners of the visual surface 911. However, it should be understood that the term "diagonal" as used herein does not require a direction between two corners, but rather requires only some lateral displacement for some longitudinal displacement. In one embodiment, the feedback array 909 is linear and is arranged along an axis 915 that forms an angle α with the longitudinal axis 901 projected onto the same plane. The feedback array intersects the longitudinal axis 901 or the center line 927 of the visual surface 911. The angle α is preferably between 0° and 90°, more preferably between 15° and 75°, and in a variant embodiment, it is about 28° or 62°.It should be understood that the feedback array may be curved, curvilinear, or non-linear, and such a feedback array may be defined as a matrix in which two or more columns extend diagonally. In a preferred embodiment, the visual surface 911 is substantially horizontal when the housing 910 is positioned in the use position with the end port 903 placed in the user's mouth.

[0032] In one embodiment, the feedback array includes a plurality of spaced-apart lights 919, 921, 923. In one embodiment, the plurality of lights includes a first outermost light 917 located closest to the user and the port 903, and a second outermost light 925 located farthest from the user and the port 903. The first outermost light 917 is adapted to be illuminated with a first color indicating that the user input is below a predetermined tolerance defined as pressure, frequency, or flow rate, and the second outermost light 925 is adapted to be illuminated with a second color indicating that the user input exceeds the predetermined tolerance. At least one of the plurality of lights 921 located between the first outermost light 917 and the second outermost light 925 is adapted to be illuminated with a third color indicating that the user input is within the predetermined tolerance. In one embodiment, the first color is blue, the second color is red, and the third color is green, provided that it should be understood that the first, second, and third colors may be any colors as long as they are different from each other.

[0033] In one embodiment, a pair of first outermost lights 919 are configured to be illuminated in a first color, a pair of second outermost lights 923 are configured to be illuminated in a second color, and a plurality of intermediate lights 921 including at least two intermediate lights and including four intermediate lights in one embodiment are located between the first outermost lights 919 and the second outermost lights 923. Preferably, the lights 919, 921, 923 are LEDs that can be illuminated in one or more colors collectively and individually. It should be noted that the first and second outermost lights can include two or more or two lights for each cluster of these lights at each end of the array 909. In one embodiment, the feedback array 909 comprises a single row of lights (e.g., LEDs) that can be separately attached or configured as part of a light bar. It should be noted that the array can include lights forming two or more rows or can include a matrix (rectangular) of lights, but only the lights extending along the diagonal are illuminated as described above.

[0034] As shown in FIG. 87, the visual surface comprises orientation markers 931, 933, 935 located below the feedback array. The orientation markers include a first arrow 931 located at one end of the array or, in one embodiment, below the first outermost light 919, and a second arrow 933 located at the other end of the array or, in one embodiment, below the second outermost light 923. A bar 935 is located below the intermediate light 921, and this bar connects the arrows 931 and 933 in a visually distinguishable manner, providing contrast for the light 921 against the visual surface. The orientation markers preferably exhibit a color different from the surrounding portion of the visual surface 911. In one embodiment, the arrows 931, 933 face each other, and in another embodiment, these arrows are directed in directions away from each other.

[0035] In one embodiment, the first outermost lamp 917 or pair of lamps 919 is adapted to be illuminated with a fourth color different from the first color, for example, to indicate a low power source or low battery 742. For example, the color may be amber or yellow. The first outermost lamp 917 or pair of lamps 919 may also be intermittently illuminated or blink with the fourth color when the appliance indicates low battery power. The first outermost lamp 917 or pair of lamps 919 may be adapted to be illuminated with yet another color different from the first or fourth color, for example, to indicate battery depletion. For example, the color may be red. In this case also, one or more lamps may be intermittently illuminated or blink on and off to provide an indication of battery depletion, or may remain illuminated. After or during charging, the first outermost lamp changes color, for example, to blue or green, to indicate that the appliance is charged and ready for use at any time. The first outermost lamp 917 or pair of lamps 919 may be illuminated with the first color (e.g., blue) when the appliance is turned on and ready for use at any time. In yet another embodiment, the first outermost lamp is illuminated with a fourth color to indicate that the appliance is not associated with a memory type storage device, for example, if an SD card is not found or is not inserted into port 424, or if a USB cable is not inserted into the port.

[0036] The housing 908 further has quantity descriptors 941, 943, 945 attached to the visual surface 911 adjacent to the feedback array 909 and the direction indicators. The quantity descriptors include a first quantity descriptor 941 attached to the visual surface adjacent to the first outermost lamps 917, 919 and a second quantity descriptor 945 attached to the visual surface adjacent to the second outermost lamps 923, 925. In one embodiment, the first quantity descriptor 941 is the word "LOW" and the second quantity descriptor 945 is the word "HIGH", provided that it should be understood that other words or alphanumeric indicators and / or arrows may also be acceptable where the feedback array adjacent to the noted first and second quantity descriptors 941, 945 is illuminated only and is not related to acceptable flow rates, pressures and / or frequencies, and in contrast, may be suitable for informing the user that they need to be increased or decreased respectively. In one embodiment, a third quantity descriptor 943 is attached to the visual surface adjacent to the intermediate lamp 921 located between the first outermost lamp and the second outermost lamp. For example, the third quantity descriptor may be provided as the word "GOOD", "Acceptable", and / or "OK", or some other word or alphanumeric indicator that informs the user that the feedback array with the intermediate region illuminated is related to acceptable flow rates, pressures, and / or frequencies.

[0037] In one exemplary embodiment, the first outermost lamps 917, 919 are illuminated with a first color (e.g., blue) when the pressure is less than 10 cmH2O ("LOW"), the second outermost lamps are illuminated with a second color (e.g., red) when the pressure exceeds 25 cmH2O ("HIGH"), and the intermediate lamp 921 is illuminated with a third color (e.g., green) when the pressure is 10 cmH2O or more and 25 cmH2O or less ("GOOD" or "OK"). As shown in Table 1 below, for example, various usage sessions are shown and the recorded data indicates the percentage of time the user exhaled in the LOW, HIGH, GOOD / OK zones. Each row in Table 1 represents a session and each column represents the type of data that was recorded and logged.

[0038] Table 1: Raw Data Log of SD Card

Table 1

[0039] It should be understood that the feedback array may be used in combination with other feedback systems including various acoustic and vibration systems.

[0040] The OPEP device described herein is a type of respiratory therapy device. However, it should be understood that the module 908 with the feedback array 909, direction indicators 931, 933, 935 and quantity descriptors 941, 943, 945 may also be joined and attached to other respiratory therapy devices including various inhalation training devices, or the visual surface 911 with the feedback array 909, direction indicators 931, 933, 935 and quantity descriptors 941, 943, 945 may also be directly attached to other respiratory therapy devices.

[0041] Similarly, the module 908 may be associated with various respiratory care systems including various drug delivery devices as shown in FIGS. 88 - 90. By way of example, but not limiting the present invention, as shown in FIG. 88, the module 908 may be operably connected to a holding chamber, for example, a valved holding chamber 1000 into which a pressurized metered dose inhaler (MDI) 1006 is inserted at one end. The module 908 is disposed on top of the holding chamber 1000 such that the feedback array 909 is visible to the user when the mouthpiece is inserted into the user's mouth (two alternative positions A, A' are shown). The module 908 includes the same feedback array 909, direction indicators 931, 933, 935 and quantity descriptors 941, 943, 945 as shown in FIG. 87.

[0042] To explain the operation, when MDI 1006 or another drug delivery device is actuated, for example, when the inhalation valve is closed, the chamber is filled with the drug. Whether separately configured or provided on the inhalation valve, in any case, a sensor, such as a mechanical flow indicator or a pressure sensor or an actuator, is in a neutral position since inhalation is not occurring. Thus, the feedback array 909 is either not illuminated or is illuminated to indicate a ready state. When the user begins to inhale, the inhalation valve opens, thereby creating a negative pressure and causing the sensor to move or record a sufficient air supply flow rate / pressure within a predetermined range. The feedback array can provide feedback similar to that described above for the exhalation flow rate / pressure of the OPEP device if the inhalation flow rate is too low or too high. Alternatively or in addition to an indication of an appropriate individual inhalation cycle, one or more lights in the feedback array should remain on and illuminated for an extended period when the treatment is complete to relay to the user that they have successfully completed the treatment, for example, if multiple breathing cycles are required.

[0043] Module 908 can also be operably connected to the dry powder inhaler 1002 shown in FIG. 89 (see Configuration Example B) and / or the nebulizer 1004 as shown in FIG. 90 (see Configuration Example C). As with prior art devices, module 908 is positioned on top of the nebulizer 1004 or inhaler 1002 such that the visual surface 911 and the feedback array 909 are visible to the user when the mouthpiece 4 is inserted into the user's mouth. Module 908 preferably has the same feedback array 909, direction indicators 931, 933, 935, and dose descriptors 941, 943, 945 shown in FIG. 87. The same process occurs with various inhalation / exhalation valves, sensors configured as flow indicators, and / or other internal sensors that record flow rate / pressure and provide input to module 908.

[0044] It should be understood that the visual surface 911, the feedback array 909, the direction indicators 931, 933, 935, and the quantity descriptors 941, 943, 945 may be provided on the upper visual surface 911 of one or more housing components (configuration examples A″, B′, C′) including, for example, the main body or its mouthpiece (but not limited to these), by providing these features thereon. They may be directly incorporated into one or more of the components such as the holding chamber, dry powder inhaler, OPEP, and nebulizer shown in FIGS. 86A and 86B and FIGS. 88 to 90. Also, these features are not limited to the module 908. For example, the visual surface 911 shown in FIG. 87 may be formed on any housing component of the device shown in the alternative configuration examples (A″, B′, C′) of FIGS. 88, 89, and 90.

[0045] Referring to another embodiment shown in FIG. 77, the T-connector has a curved wall 780 that extends under the port. The curved wall combines with the lower side portion 674 of the membrane 660 to define a second chamber 782. The damping orifice 784 extends through the curved wall and enables fluid communication between the flow channel 624 and the second chamber 782. In one embodiment, the damping orifice 784 has a diameter in the range from 0.5 mm to 1.5 mm. Thus, the first and second chambers 684, 782 are configured on the sides opposite to the side of the membrane. The first chamber is hermetically sealed, and the second chamber 782 is in fluid communication with the flow channel via the damping orifice.

[0046] Referring to FIGS. 53 - 56, during the application of the OPEP therapy method, the oscillating backpressure is transmitted to the user of the OPEP device, and this oscillating backpressure is received by the user at the mouthpiece. When the adapter and the user interface / control module 408 are connected to such an OPEP device, for example, the OPEP device 2, the oscillating pressure is transmitted from within the main body 402 through the conduit 404 to the user interface / control module 408. However, the oscillation of the pressure is attenuated by the pressure stabilization orifice 407 because the flow of air along the conduit 404 through the pressure stabilization orifice 407 is restricted. After the pressure is attenuated by the pressure stabilization orifice 407, the pressure is received and measured by the user interface / control module 408, thereby providing the user with a visual display of the pressure achieved during the application of the OPEP therapy. Thereby, the user or caregiver can monitor the treatment plan or therapy to ensure that the appropriate pressure is achieved over the prescribed period. In some cases, a treatment plan or therapy that alternates between breathing at a high pressure for a predetermined period and breathing at a low pressure for a predetermined period may be desirable. The visual or audible display of the pressure achieved during treatment allows the user or caregiver to determine the level of compliance with the prescribed treatment plan or therapy. Various components of the OPEP and the adapter are disclosed in U.S. Patent Application Publication No. 2015 / 0224269 (A1) published on August 13, 2015, which is hereby incorporated by reference in its entirety and made a part of this specification.

[0047] The shaded area 50 in FIG. 2 represents the internal volume constituted by, for example, the mouthpiece chamber 48 that becomes pressurized when the valve mechanism is closed. The shaded area located outside the OPEP device boundary represents the "smart" features including three operations: input, analysis, and output. The input may preferably come from the high - pressure zone 50 as shown in FIG. 2, for example, from the adapter, although this input may come from another part of the device depending on the measurement being taken or recorded.

[0048] Input The term "input" means any information entering the smart OPEP system, and this input may take the form of raw data from sensors, commands to initiate processes or personal data entered by the user. For example, the input may be a signal from one or more input components, such as a sensor. For example, as shown in FIGS. 3 and 4, a pressure sensor 52 generates an electrical signal as a function of the pressure within the system or chamber 48. The pressure sensor can calculate any of the performance characteristics described above and be used to evaluate the user's technique. The sensor assembly 54 may include a housing 202 for the pressure sensor 52 disposed on a printed circuit board (PCB), a BTLE module 56, a processor (e.g., a microprocessor) 60, an LED display 154, a memory, a wireless communication function, and a battery 58 or solar-assisted charging. This sensor assembly may communicate with an output component, such as a mobile device 62 including a computing device (e.g., a smartphone or tablet computer) of the user (patient, caregiver, and / or other authorized user). This assembly may be configured as a removable control module 608, 908 shown in FIGS. 66A - 69 and FIGS. 79 - 84. A single pressure sensor 52 can provide all of the measurement requirements. The pressure sensor may be a differential, absolute, or gauge type sensor. The sensor assembly is coupled to the OPEP device with a cover 64 covering the assembly. The input component is considered to be in "contact" with the chamber 48 even if it is separated from the interior of the chamber by, for example, a membrane or other substrate (see FIGS. 60, 61, and 68) if it can detect or measure the pressure or flow rate within the chamber 48. The input component operates to detect the flow rate and / or pressure and generate an input signal that is correlated with the flow rate or pressure.

[0049] Referring to FIGS. 5A - 5G, various flow sensors are shown that generate an electrical signal as a function of the air flow 70 within the system. The flow sensors can be used to calculate a frequency and to evaluate the user's technique. The flow sensors include those incorporating a venturi 78 within the shape of a mouthpiece chamber (FIG. 5A), a Pitot tube 72 that incorporates Pitot tubes that determine the fluid velocity by comparing the pressure generated by the flow stagnation at the inlet of the Pitot tube with the pressure of the surrounding fluid (FIG. 5B), or those that calculate the flow rate based on the time difference proportional to the flow velocity using a voice transmitter / receiver 74 to measure the time required for the voice to travel from transmitter 1 (74) to receiver 2 (80) and then from transmitter 2 (80) to receiver 1 (74) (FIG. 5C). As a variant, as shown in FIG. 5D, the air flow causes a displacement in the magnetic component 82, and this displacement changes the inductance of the coil 84. The inductance of the coil is associated with the displacement, and this displacement can be correlated to the flow rate. When there is no flow, a biasing spring 86 (e.g., tensile or compressive) may be provided to return the magnet to the "zero flow" position. Referring to FIG. 5E, the air flow causes a vane 88 to move, which changes the resistance of the potentiometer 90, and this resistance is associated with the flow rate. Again, when there is no flow, a biasing spring 92 (e.g., torsion) may be provided to return the vane to the "zero flow" position. Referring to FIG. 5F, for example, a vane 94 having a plurality of blades rotates in response to the flow, and the speed of the rotating shaft 96 is correlated to the flow rate proportional thereto. Referring to FIG. 5G, the flow 70 passes over a heater wire 98, and this heater wire begins to cool. A larger current is passed through the wire to maintain a constant temperature, and the magnitude of the measured current is correlated to the flow rate.

[0050] Referring to FIGS. 43A, 43B, 68, and 82, the control modules 54, 608, 908 are not in fluid communication with the internal volume portion, such as the mouthpiece chamber 48 or the flow channel 624, or the OPEP device, and are separated therefrom by flexible membranes 200, 660, unlike these. The flexible membranes 200, 660 move in response to changes in pressure within this device, such as chamber 48 or flow channel 624. Thus, the control modules 54, 608 are in fluid communication with chamber 48 or flow channel 624 by the pulsations from membranes 200, 660, but the control modules 54, 608, 908 are not in fluid communication with chamber 48 or flow channel 624.

[0051] In this way, the OPEP device or the housing can be cleaned without damaging the electronic components, and such components are also not in fluid communication with the user's inhalation and / or exhalation as respiration or flow. When the control module is removed or moved to a non-installed position, the flexible membrane 200 remains attached to the housing 6, and the membrane 660 remains attached to the T-connector 620, for example by a tether, even if this membrane is moved to a non-installed position.

[0052] In the stopped state, the pressures in the OPEP chambers 48, 14a, 14b are atmospheric pressure or ambient pressure. The pressures (P) in the flow channel 624 and in the first and second chambers 684, 782 are the same. When the pressure in a chamber or flow channel increases, an upward / outward force is applied to the membranes 200, 660, causing the membranes to move towards the module 54. Since the measurement chambers 202, 684 formed between the membranes 200, 660 and the module are sealed by the membranes, the volume of air in the measurement chambers 202, 684 decreases while the pressure in the chambers 202, 684 is increasing. The control module measures the pressure change in the sealed measurement chamber and calculates the pressure in the OPEP chamber 48 (or 14a, 14b) or in the flow channel 624 using a conversion algorithm. During inhalation, the pressures in the chambers 48, 14a and / or 14b and the flow channel 624 become negative, which exerts a downward or inward force on the membranes 200, 660. When the flexible membranes are pulled away from the control modules 54, 608, 908, the pressure in the measurement chamber decreases or becomes negative. Also in this case, the control modules 54, 608, 908 measure this pressure chamber and calculate the corresponding or actual pressure in the chamber 48 or the flow channel 624. Thus, the modules 54, 608, 908 measure the pressure without being in fluid communication with the chamber 48 or the flow channel 624 and the user's inhalation / exhalation flow.

[0053] Referring to FIGS. 77 and 78, the damping orifice 784 can pre-damp the pulsations of the membrane 660, thereby smoothing the pressure curve with reduced pulsations, resulting in easier analysis and more accurate output for the algorithm.

[0054] Referring to FIGS. 44, 83 and 84, the controller 158, the BTLE module, the LED display, the memory, and the pressure sensor are in electrical contact with a power source, such as a battery. The controller receives signals from the pressure sensor and transmits and receives data to and from the BTLE module, which in turn communicates with the mobile device 62 or other user interface and / or processor. The controller can also send signals to the LED displays 154, 750 as needed, and can save data to and retrieve data from the internal memory. The data can further be transmitted to and stored on a memory card 950, an SD card placed in a port, or via a micro USB port. A real-time clock 952 and a backup battery 954 may also be incorporated in the PCB board 940.

[0055] Referring to FIGS. 6, 7A and 7B, a flex sensor 100 is shown disposed adjacent to a high-pressure cavity or zone defined by a chamber 48. The resistance through the flex sensor is proportional to the amount of flex applied, and such resistance can be used as an indirect measure of pressure. The flex sensor may be positioned on the low-pressure side of a silicone membrane 102. The membrane 102 moves in response to an increase in pressure within the cavity or system, thereby flexing the sensor 100 that is cantilevered on the membrane or an actuator pad extending therefrom. The membrane 102 may have an actuator pad 104 that engages the flex sensor 100. The change in resistance due to flex can be correlated to the pressure within the system. The electronic components including the sensor are separated from the flow path by a membrane 102 that prevents contamination. The cleanliness of the flow path can be said to be particularly important for CF patients. At the same time, the electronic components can be easily removed for cleaning and disinfection.

[0056] Referring to FIGS. 8A and 8B, the non-contact position sensor 106 can provide either the absolute or relative position of an object, and such non-contact position sensors, like the flexure sensors, can be used to indirectly measure pressure changes. Some forms of non-contact position sensors are capacitive displacement sensors, ultrasonic sensors, and proximity sensors. Using these sensors, the displacement of a movable surface in response to a pressure change can be measured. In the ambient or atmospheric pressure state, the base component 108 coupled to the silicone bellows 112 is positioned at a distance of "x" mm from the sensor 110. When the pressure increases, for example, the base 108 attached to the rolling bellows is moved towards the sensor 110, e.g., a capacitive displacement sensor, and the distance "x" decreases. Thus, the distance between the base 108 and the sensor 110 is inversely proportional to the pressure. When the pressure increases, the distance decreases, and the reverse relationship also holds. The sensor can also measure negative pressure, for example, when the distance "x" is increasing.

[0057] If the pressure inside the instrument is too high, the silicone bellows should not be so rigid that it resists descending all the way down. As shown in FIG. 9, a support spring 112, e.g., a mechanical compression spring, may be provided between the base 108 and the sensor 110. In this way, the system can measure the increased pressure. Similar to the embodiments of FIGS. 7A and 7B, the electronic components of FIGS. 8A, 8B, and 9 are separated from and isolated from the flow path by a silicone membrane or bellows. Additionally, the electronic components may be removable.

[0058] Referring to FIG. 10, a linear variable differential transformer (LVDT) 112 is shown. The LVDT is a contact sensor that directly measures the linear displacement of the flexible membrane 102 or the base 108 shown in the previous embodiments. The displacement can be correlated to the pressure.

[0059] Referring to FIG. 11, a conductive membrane 114 is provided. This membrane is made using silicone with conductivity. When the pressure within the system increases, the membrane flexes and its resistance or capacitance changes, which can be correlated with the pressure.

[0060] Referring to FIG. 12, a magnet 116 has a spring. When the pressure within the system is changing, the distance between the magnet and the Hall effect sensor 20 can be correlated with the pressure. A return spring 118 may be coupled to the magnet.

[0061] Referring to FIG. 13, an optical curtain 122 can be used to determine the displacement of a membrane 124 that is displaced by pressure. When the pressure increases, the base or platform portion 126 of the membrane moves through the optical curtain 122, and this movement is correlated with the pressure.

[0062] Referring to FIGS. 5E and 14, a potentiometer vane 88 is provided within the flow path 70. The amount of rotation of the vane is proportional to the flow rate within the chamber and ultimately to the pressure. When the flow rate is zero, a return spring 92 is incorporated into the rails to reset the vane.

[0063] Referring to FIG. 15, a piezoelectric bending sensor 128 is provided within the flow path. The bending sensor bends in response to the airflow within the chamber. When the sensor bends, its resistance changes. The change in resistance can be correlated with the flow rate and pressure.

[0064] Referring to FIGS. 16 and 17, a proximity sensor 130 is used to detect the presence of nearby objects without physical contact. In this case, the proximity sensor 130 is used to detect whether the tip of the vane 134 is present. Each time the vane vibrates, the sensor detects its position, and then the calculation of the time between vibrations becomes possible. In the closed position, the vane comes within 5 mm of the sensor at the highest resistance setting. A lower resistance setting will reduce the distance between the vane and the sensor.

[0065] Another embodiment uses a proximity sensor 136 to monitor the control nozzle 30. When the valve / vane mechanism 134 opens and closes to produce pressure oscillations, the flow rate within the appliance also varies oscillatingly. When the flow rate is high, the control nozzle 30 is in an open state; when the flow rate is low, the control nozzle is in a closed state. The opening / closing operation of the control nozzle can be detected and such operation can be converted to a frequency.

[0066] When an accelerometer measures an appropriate acceleration and such an accelerometer is used, the frequency can be calculated from the vibrations when the valve / vane mechanisms 26, 134 are opening and closing. The accelerometer is preferably placed on the appliance at the location that results in the largest vibrations.

[0067] A microphone 140 similar to the microphone shown in FIG. 18 is mounted on the PCB and preferably placed at the same location as the proximity sensor of FIGS. 16 and / or 17. The microphone picks up the sound of the start and stop of the air flow and, in addition thereto, any mechanical contact that occurs with the vibrating mechanism.

[0068] Using an LED 142 and a light sensor 144, the frequency of the vibrating mechanism can be calculated. In this configuration, the LED is placed on one side of the butterfly valve 146 and the light sensor is located on the other side. When the valve opens, light passes through the valve seat and is measured by the light sensor. When the valve closes or engages the valve seat 148, the light is blocked from reaching the light sensor. Using the timing of this data, the frequency can be calculated.

[0069] Another LED / optical sensor configuration is shown in FIG. 20. In this configuration, the LED is disposed on the opposite side of the vane chamber 14b, and the optical sensor is disposed on the side wall by one of the exhaust ports 18. When the vane 134 rotates to one side, this vane blocks the light from reaching the optical sensor. When the vane rotates to the other side, the light from the LED can reach the optical sensor. Using the timing of this data, the frequency can be calculated.

[0070] Referring to FIG. 21, the mobile device 62, such as a smartphone, may include an app that provides INPUT if the smart feature is not integrated into the OPEP appliance. The app can enable the selection of the desired feedback and the adjustment of the target and / or limits.

[0071] It is good to calculate the QoL score using the input related to the user's quality of life and correlate this QoL score with the DFP performance. Using various inputs, the QoL score can be calculated, and the algorithms can be freely created or adjusted according to different disease types. The user input can be executed by an auxiliary input component, such as a computer device, such as a smartphone app. Some examples of QoL inputs are as follows. St. George's Respiratory Questionnaire for COPD Simplified Questionnaire User's Journal Steps / Day Number of hours the user is sitting

[0072] For various features and inputs for "starting" the device, one or more of, but not limited to, an accelerometer, pressure sensor, flow sensor, humidity sensor, temperature sensor, mechanical switch / button, pressure switch, flow switch, temperature switch, infrared sensor, mouthpiece or conductive switch / lip provided in a hand-on device / closed circuit, humidity sensor, flex sensor provided on a membrane, capacitive displacement sensor, linear variable differential transformer, conductive membrane, microphone, MAF sensor, hot wire, programmable timer / user / alert reminder may be included. For various features and inputs for session identification (ID), session "start" and "stop" times, and "duration", a software clock and / or algorithm may be included. For various features and / or inputs for "breath counting", one or more of, but not limited to, an accelerometer, pressure sensor, flow sensor, humidity sensor, temperature sensor, microphone and / or mechanical switch may be included. For inputs and characteristics for mean pressure and mean frequency, one or more of, but not limited to, the various sensors disclosed throughout this specification may be included. The "instantaneous pressure alert" may preferably include an algorithm that alerts the user in real time when a predetermined (pre-set) maximum pressure threshold is exceeded. The alert may preferably be visual (LED, screen display), tactile or audible. One or more of the mucus count (lung obstruction level), cough count, and / or wheeze count can be calculated by an algorithm from humidity, temperature, and microphone sensor data, and the algorithm may, for example, provide a rating for each on a scale of 1 to 10. Respiratory temperature can be calculated by a temperature sensor and respiratory humidity can be calculated by a humidity sensor. The alert timer may preferably be a programmable feature that warns / reminds the user to use the device. Activating the snooze button can reset / snooze the alert for a predetermined period (e.g., 10 minutes) up to a maximum reset count (e.g., 6 times), and then the reminder is automatically turned off.Session pause / resume features provide the user with flexibility to pause a therapy session, for example, if something important interrupts the session, and then resume the session once convenient. The algorithm calculates the actual usage time by eliminating the pause time. The cleaning reminder may be visual (flashing LED light), audible (audible tone), or tactile. Timed reminders based on, for example, the actual time used, number of uses, number of breaths, and / or total time, or some combination thereof, provide a sign or reminder to clean the device as recommended. The reminder may be programmed to give an alert that fits a specific schedule. The device replacement alert provides a sign or prompt to the user and / or other beneficiaries that the device needs to be replaced. The reminder may be visual (flashing LED light), audible (audible tone), or tactile. The alert may be based on, for example, the actual time used, number of uses, number of breaths, and / or total time, or some combination thereof. The alert may be programmed to give a warning to fit a specific schedule. The treatment completion notification may be based on an algorithm that calculates the session time based on the amount of breathing and the quality of the session (e.g., average pressure within a recommended range (e.g., 10 - 20 cm / H2O)). Data can be transferred to a connected device (whether hard-wired or wireless) including USB, Bluetooth®, Wi-Fi, and other known communication systems.

[0073] Output Referring to FIGS. 22 and 23, the output is defined as new information exiting the smart OPEP “system” and this information is communicated by the output component. The output can take the form of visual, auditory (audible), and sensory feedback, or such output can be related to the user's quality of life and the progression of the disease. Many outputs and output components are suitable, and such outputs and output components include visual output components that can be easily integrated into the smart OPEP and enable several levels of feedback. For example, an array 150 of three LEDs 152, each having a different color, can indicate whether the input is low, high, or acceptable. Instead of three separate LEDs (e.g., red, amber, and green), a single tri-color LED 154 can also be used. If feedback of four or more discrete states is required, one of the LED arrays or a bar graph 156 can be used. As described above, the output can also be communicated by the visual surface 911, the feedback array 909, the direction indicators 931, 933, 935, and the quantity descriptors 941, 943, 945.

[0074] Referring to FIGS. 51, 55, and 59, the user interface may further include a display screen 420 (e.g., an LED display screen) that can display various data and information in both real-time and command / search-based manners. The user interface / control module 408 may further include a micro USB port 422 for data transfer and / or charging of the module. The module 408 may preferably further include a micro SD card port 424 into which an SD card can be inserted to exchange (upload / download) data. The control module can provide an audible output, can further recognize, and may preferably further include a microphone and / or a speaker 426 for audible input and commands that can be obeyed in a state operated / acted upon by the control module 408. The user interface may preferably include a touch screen for inputting data and instructions to the control module.

[0075] Auditory (audible) and sensory / tactile (vibration) outputs and output components can also be used to provide feedback to the user. For example, a sound or vibration occurs while the input is within an acceptable range or when the input exceeds a specified limit.

[0076] The mobile device 62 or other computer interface can function as an output component and can interface with a smartphone app as an output when the smart features are not incorporated in the OPEP appliance. The app may display real-time performance characteristics, data trends, or a game to arouse the user's interest in completing a session.

[0077] Referring to FIGS. 62 to 76B and FIGS. 83 to 87, the operation of the smart OPEP provides a smart data logger (automatic recorder). It should be understood that the user interface and control module can be used in combination with other forms of respiratory management systems. The user interface provides various useful information that can be used by the patient / user, caregiver (e.g., physician), insurer, and other healthcare providers to further improve the health of the patient / user. The user interface can provide information and guidance regarding the timing of use of the device to various beneficiaries, alert when a preset (input) pressure threshold is exceeded, provide information regarding the time (e.g., at regular intervals) when the device should be cleaned with minimal input from the user, and inform the user and / or other intended beneficiaries of the time when the treatment session is completed. In one embodiment, the user may pick up the device, use the device with minimal interaction / effort (e.g., without manual logging or by interfacing with an electronic input device), and return the device until the next use. The control module can record all the information collected by various sensors and other inputs, and display this live to the user via, for example, a display 420, or log / record the data for later review by downloading it to a computer or other device via, for example, an SD card inserted into a port 424 or a USB port 422. The device can also wirelessly transfer data to devices such as a PC, tablet, smartphone (e.g., mobile app), and other known and suitable devices. As mentioned, the module may have a connection (hardwire or wireless) to a live display 420 or a smart device equipped with a digital display, in which case either the module (via the display 420 or microphone 426) or the digital display can alert the user or other intended beneficiaries when it is time to perform a treatment session, inform the user of the time to clean the device, inform the user of the time to replace the device, and / or inform the user of the time when the treatment session is completed.The apparatus can also inform the user or the intended beneficiary about session duration, number of breaths taken, average treatment pressure, average treatment frequency, maximum pressure warning, low battery warning, mucus obstruction level, cough intensity level, wheezing sound intensity level, respiratory temperature and respiratory humidity level. The communication of the apparatus with the user may be visual, auditory (audible) or tactile. The user may also operate a push button or actuator 430 to delay or reset (e.g., snooze) the reminder alarm if it is inconvenient at that time. The actuator can also be operable to turn on (activate) or turn on the power of the module.

[0078] In the embodiments of FIGS. 79 to 87, the accelerometer 930 detects motion, for example, motion in the range of 0 to 1G, to activate the apparatus. Conversely, if the apparatus is left in its current state, the apparatus times out and automatically enters the sleep state.

[0079] When explaining the operation principle, referring to FIGS. 63 to 76B as well as FIGS. 85, 85A and 85B, the module can provide a session reminder, such as an auditory or visual alarm. The time and frequency of the reminder may preferably be programmable by the user and / or other providers nearby or remotely. Once the alarm is activated, the user can reset the alarm with a delay (i.e., snooze), for example, for 10 to 30 minutes, by activating the actuator 430, or can completely cancel the time, for example, by continuously pressing a button or entering a series of button presses. If the snooze is not activated, the module will then determine whether an input has been received from one or more sensors, and such sensors include a pressure sensor, a flow sensor, a humidity sensor, a temperature sensor, a flexion sensor or membrane, a capacitive displacement sensor, a linear variable differential transformer, a conductive membrane and / or an optical curtain. For example, an input regarding whether the user is blowing air into the appliance is detected. When an input, movement and / or action is detected, the LED is activated and the appliance starts up with the time / date of the session logged. If no input or action is detected, the appliance will enter the sleep mode again.

[0080] For example, once the instrument is powered on by turning on switch 430 or by the detected motion by accelerometer 930 (see FIGS. 67, 85A, and 85B), the algorithm calculates and records the average pressure of the session using the input from one or more sensors, such sensors including, for example, pressure sensors, flex sensors provided on the membrane, capacitive displacement sensors, linear variable differential transformers, conductive membranes and / or light curtains, or combinations thereof, but not limited thereto. The frequency of the session (e.g., its average value) may also be recorded based on the input from one or more sensors, such sensors including pressure sensors, accelerometers, flex sensors provided on the membrane, microphones, capacitive displacement sensors, linear variable differential transformers, conductive membranes, and / or light curtains, or combinations thereof, but not limited thereto. The number of breaths during each session may also be recorded based on the input from one or more sensors, such sensors including pressure sensors, flow sensors, humidity sensors, temperature sensors, flex sensors provided on the membrane, microphones, capacitive displacement sensors, linear variable differential transformers, conductive membranes, and / or light curtains, or combinations thereof, but not limited thereto. When the user continues to interface with the instrument, for example, by blowing air into the instrument, the sensors and modules continue to record and calculate data. Once it is determined by the sensors and modules that the user is no longer using the instrument, for example, not blowing air into the instrument, the instrument may time out after a predetermined period (e.g., 10 seconds to 5 minutes), or the instrument may turn off the switch with a sign that it is no longer powered, such as one of the lights of LED, i.e., array 909, on. It is good to store the data in an SD card and / or transfer it either to a mobile app, whether hard-wired or wireless to a personal computer in any case.

[0081] During use, the visual display may preferably display or provide the session date, start time, session duration timer, session pause / play interface (e.g., touch screen actuator), breath counter (number of exhalations), average exhalation duration, average pressure, average frequency, instantaneous pressure alert (e.g., maximum overshoot), mucus count / score, cough count / score, wheeze count / score, breath temperature, breath humidity, average breath time with pressure higher than 5 cmH2O (%), a label regarding the device cleaning reminder or device life status. It may preferably store the same data / information together with the session identification and start time. The LED display and array 909 may preferably be powered off after the session ends and the device enters the sleep mode.

[0082] Referring to FIG. 65, it may be good to activate the actuator, for example, by pressing a button to start the device or the accelerometer may preferably start the device, thereby activating the visual display, for example, the LED light. When the user blows air into the device, for example, the mouthpiece, the algorithm may preferably calculate the number of breaths per session, the average pressure during the session, and the instantaneous pressure (e.g., maximum) (manometer) using the pressure sensor 434 or the micro heat flow sensor 436 again. The LED array 909 may preferably provide the user with a real-time visual display or feedback regarding the instantaneous pressure, for example, red (too high or maximum overshoot), amber (reaching / approaching the maximum), or green (within a predetermined acceptable range).

[0083] The pressure sensor 434,730 or the micro thermal flow sensor 436 may be separated from the OPEP flow channel by a flexible membrane 440,660, and the membrane defines sealed chambers 438,684 as shown in FIGS. 60 to 76B. The indirect pulsating pressure created by the membranes 440,660 in the chambers 438,684 in response to the pulsating pressure in the OPEP is detected by the pressure sensors 434,730. Similarly, the indirect pulsating air flow created by the membrane 440 in response to the pulsating pressure in the OPEP is detected by the micro thermal flow sensor. For example, the pulsating pressure in the OPEP may be 0 to 60 cmH2O.

[0084] Feature: Performance target This feature provides feedback to the user based on specific performance targets. For example, if the average pressure is within 10 to 15 cmH2O or within 10 to 25 cmH2O, this feature will notify the user that this average pressure is too high, too low, or acceptable. As a means of this notification, for example, providing feedback by the feedback array 909 can be mentioned. The performance target may be set by the patient or a healthcare provider, or may default to a limit based on a generally accepted treatment protocol.

[0085] A general layout regarding this feature is shown in FIG. 24, and such a layout may include (but is not limited to) any one or a combination of the sensors disclosed earlier in this specification, such as the sensor 154, and functions for processing raw data including, for example, a processor 158 and output components 150,154,156 for displaying feedback, and a function for manually inputting performance limits if necessary. The location of the sensor may vary according to the selected sensor type or the performance characteristics during measurement as disclosed in this specification for various embodiments.

[0086] The performance characteristics that can be included in this feature have been described above and are mentioned in this specification. Table 2 below lists exemplary performance characteristics and various suitable sensors for measuring these performance characteristics. Table 2: Performance Characteristics [Table 2]

[0087] A flowchart regarding this feature is shown in FIG. 25. The area shown by the dashed line indicates an integrated embodiment that cannot adjust the target limit and, in this case, provides feedback regarding the average pressure.

[0088] To explain the principle of operation, the user first selects the form of feedback. "Get Type and Set Type" define the performance characteristics to be analyzed. Next, the user determines whether to use a custom target and enters a limit. If not, the default limit is set based on the selected performance characteristics. Next, sensor 154 starts transmitting raw data and calculates the selected performance characteristics. Next, a series of decisions are made based on the calculated "value" of the performance characteristics. If the "value" is greater than the upper limit, the output is "high". If this value is lower than the lower limit, the output is "low". If the value is neither, the output is "OK", and this information is reported to the user via feedback array 909 during use. Next, the flowchart checks whether the user has selected to end the feedback. If not, the cycle repeats. The logic described above provides three separate states regarding feedback. If necessary, additional logic can be added to provide a more refined solution for the feedback.

[0089] The analysis may be completed using a processor 158 embedded within the PCB, such as a microcontroller, or alternatively may be implemented using an external computing device, such as a mobile device including a smartphone or tablet. As understood from Table 2, the frequency may be determined from any sensor, although a pressure output requires a pressure sensor (either direct or indirect). To calculate the frequency from the pressure input, it may be beneficial to use a processing technique, such as peak-to-peak time, Fourier analysis, or autocorrelation. FIG. 1 shows an example of a pressure waveform processed using the peak-to-peak technique.

[0090] If the input is an audio signal, averaging this audio signal can simplify the waveform. The simple waveform can then be processed in the same manner as the pressure signal for determining the frequency. Referring to FIG. 26, the raw audio data (bars) are averaged using the root mean square, and the result is shown as a line. Each peak (dots) is then identified, the time between the peaks is calculated, and this is used to determine the frequency.

[0091] The output for this feature may be visual 160, auditory 162, or sensory 164, and such output can be integrated within the instrument. An example of an integrated solution is shown in FIGS. 4 and 27 - 29. In one embodiment, the integrated solution does not result in a selection of performance features or adjustment of performance limits. In other embodiments, the integrated solution can provide a user interface that enables such selection and adjustment, for example, via a keypad, buttons, or touch screen.

[0092] Referring to FIG. 31, an algorithm for calculating performance characteristics is shown. Such an algorithm includes a step of recording raw data and a step of filtering or smoothing the raw data to remove noise if any. Such steps can be achieved by known techniques including moving average, Butterworth filter, Fourier filter or kernel filter. The direction of the gradient, whether positive or negative, is obtained using the filtered / smoothed data, with an increase = +1 and a decrease = -1. Positive and negative gradient changes are identified and labeled as peaks, and a change from negative to positive is labeled as a trough. For each peak and trough, the time stamp and pressure value are logged. Exemplary data are shown in FIGS. 46A and 46B. Using the time and pressure values for each peak and trough, the frequency, amplitude and average pressure are calculated.

[0093] Frequency analysis can be performed using the time and pressure data shown in FIGS. 46A and 46B. For example, the waveform generated by the pattern shown in FIG. 46A was analyzed. As a means, a moving average was applied to remove noise and find the peaks. The time (t) between the peaks was calculated, and this time outputs the frequency (f), where f = f sample / t, and in this case, f sample = 1000 Hz.

[0094] A computing device, such as a mobile device including a smartphone 62, can function as an output device (and further a manual input (auxiliary input component) and an analysis source). In these examples, the smart OPEP communicates with the smartphone via a wireless protocol, such as Bluetooth (registered trademark) shown in FIG. 30. An application (app) allows the user to input desired performance characteristics and set limits if necessary (FIG. 21). The output screen 170 and / or the feedback array 909 will display the target limits and provide feedback (e.g., too high, too low, or OK) to the user as shown in FIGS. 21, 23, 32, and 87.

[0095] Referring to FIGS. 33 and 34, another possible output for this feature may be to change the session to a game. For example, referring to FIG. 33, the bird 180 represents the current performance characteristic value, and this bird must pass through the pipe 182 without passing outside the limits (upper and lower limits) 184, 186. When both frequency and pressure targets are required, care must be taken to ensure that the user is not confused by the feedback and that these breathing techniques can be compensated to meet the required targets. It may be beneficial to develop a custom output graphic to assist the user in controlling two performance characteristics, such as frequency and pressure. FIG. 34 shows an example of a simple game that can assist the user in controlling both frequency and pressure. The objective of the game is to get the ball into the hole, and the current position of the ball depends on the frequency and pressure.

[0096] Referring to FIGS. 45, 85, 85A and 85B, to start a treatment session, the user first automatically activates the OPEP device, for example, by pressing a manual button or by using the accelerometer 930 when picking up the device. Once activated, the device pairs with a mobile device, such as a smartphone, if available. If the mobile device is available, it is advisable to open the application and download any previous data saved in memory to the mobile device. The user may be prompted to modify the performance metrics if necessary. Once the performance metrics are set, the application opens a feedback screen to allow the user to monitor these performances throughout the treatment. If the smartphone is not available, use the previous performance metrics and save the data internally. The OPEP device starts monitoring for positive pressure. If at any point during the treatment the device does not detect a positive pressure change over a specified time, the device saves no treatment data to the mobile device or internal memory, enters standby mode, and conserves power. If positive pressure is detected, the OPEP device begins to measure the pressure (positive and negative), calculates performance characteristics such as frequency, amplitude, and mean pressure, and provides feedback to the user regarding these techniques.

[0097] For example, referring to the embodiments of FIGS. 86A, 86B, and 87, one embodiment of a method of using a vibrating expiratory positive pressure device includes receiving real-time feedback from a feedback array 909. Specifically, the user exhales into the mouthpiece 4 through the end port. Prior to and during exhalation, the user visually inspects the feedback array provided on the visual surface 911 to see if the device is properly powered, if it is ready for use at any time, and ultimately, to receive feedback on whether the pressure, flow rate, and vibration are within a predetermined acceptable range during use. For example, at least a portion of the feedback array 909 may be illuminated to indicate whether the exhalation flow rate or pressure is within or outside a predetermined acceptable range. Specifically, the first outermost lights 917, 919 may be illuminated in a first color when the exhalation flow rate or pressure is below the predetermined acceptable range, the second outermost lights 925, 923 located at the opposite end of the array may be illuminated in a second color when the exhalation flow rate or pressure is above the predetermined acceptable range, and at least one of the plurality of lights 921 located between the first outermost lights and the second outermost lights may be illuminated in a third color when the exhalation flow rate or pressure is within the predetermined acceptable range. As described above, in one embodiment, the first color is blue, the second color is red, the third color is green, the first outermost lights may include a pair of outermost lights 919 or three or more first outermost lights, the second outermost lights may include a pair of second outermost lights 923 or three or more second outermost lights, and at least one of the plurality of lights 921 located between the first outermost lights and the second outermost lights may include at least two intermediate lights, in one embodiment, four intermediate lights. The user can also visually inspect the direction indicators 931, 933, 935 located under the feedback array and the quantity descriptors 941, 943, 945 provided adjacent thereto, thereby providing further feedback regarding the illumination sequence, use, and operation of the device.For example, the user can visually observe the quantity descriptors 941, 943, 945 together with the illuminated lamp and increase them with an arrow pointing towards the intermediate array where the flow rate / pressure (for example, the lamp adjacent to the "LOW" descriptor is illuminated) is indicated as "GOOD", or decrease them with an arrow pointing towards the intermediate array where the flow rate / pressure (for example, the lamp adjacent to the "HIGH" descriptor is illuminated) is indicated as "GOOD". The lamp itself may be suitable for providing feedback, but the combination of the lamp, the direction indicator, and the quantity descriptor maximally enhances compliance and proper use through the consolidated feedback provided to the user.

[0098] The lamp can also be illuminated in other colors or sequences to provide other indicators or feedback. For example, without limiting the present invention, the first outermost lamps 917, 919 may be illuminated in a fourth color different from the first color when the power supply drops below a predetermined power level, or the first outermost lamps may be illuminated in a fifth color different from the fourth color when the power source is turned off. The first outermost lamps may also be illuminated in the fourth color when the appliance is not associated with a memory type storage device, for example, when an SD card is not inserted into the SD card port, or when a USB cable is not inserted into the USB port.

[0099] During treatment, by providing user feedback, the user is more likely to interact with the system, thereby ensuring user engagement and improving overall treatment compliance. Due to the diagonal orientation of the feedback array 909, the user can view the progress (from left to right or right to left) in a lighting sequence from low to high or from the middle outwards. Due to the diagonal alignment of the feedback array 909, the user can easily view the feedback array 909 in their peripheral vision even when performing other tasks, such as watching TV. The diagonal alignment along the visual surface is highly visible and eliminates the need to project the lights 919, 921, 923 too far out from the top surface, thereby keeping the size of the respiratory therapy device as compact as possible. Furthermore, the order and color arrangement of the lights are easy to understand and provide an attractive interface for the user.

[0100] One aspect of the embodiments disclosed herein relates to the handling of data. It is preferable to transfer the data logged by the OPEP to an external device, such as a smartphone, tablet, personal computer, etc. If such an external device is not available, the data may be stored internally in the OPEP in a data storage module or other memory and transferred during the next synchronization between the OPEP and the external device. Software may perform data transfer and analysis along with the OPEP.

[0101] To enable the quick and accurate processing of data generated within the smart OPEP, such as data from one or more various sensors, the data may be wirelessly transmitted to a smartphone, local computing device, and / or remote computing device to interpret and act on the raw sensor data.

[0102] In one embodiment, the smart OPEP includes circuitry for transmitting raw sensor data in real time to a local device, such as a smartphone. The smartphone can display graphics or instructions to the user and can execute processing software to interpret and act on the raw data. The smartphone preferably has software that filters and processes the raw sensor data and outputs the appropriate status information contained in the raw sensor data to a display on the smartphone. As a variant, the smartphone or other local computing device can use its local resources to contact a remote database or server, thereby retrieving processing instructions or transferring the raw sensor data for remote processing and interpretation, and receiving sensor data that has been processed and interpreted for display to the user or a user or caregiver with the user of the smart OPEP from the remote server.

[0103] In addition to simply displaying data, statistics, or instructions on the display of a smartphone or other local computer located near the smart OPEP, it is advisable to actively manage and control the previous operations related to the smart OPEP. For example, if it is determined by the smartphone or other local computer located near the smart OPEP that the sensor data indicates the end of a treatment, or if it is determined that further treatment is required, the smartphone or other local computing device can convey such information directly to the patient. Other variants are also envisioned, for example, if a remote server that is in communication with the smartphone or is in direct communication with the smart OPEP via a communication network can provide information and instructions to the patient / user.

[0104] In yet another embodiment, real-time data collected by the smart OPEP and relayed to a remote server via a smartphone can trigger the remote server to look for issues related to patterns that have occurred over time based on a particular treatment session or past treatment sessions for a particular user and notify a physician or supervising caregiver. Based on data from one or more sensors within the smart OPEP, the remote server can issue a warning and send it to the user, the user's physician, or other caregiver via text, email, or other electronic communication medium.

[0105] The electronic circuits of the above-described smart OPEP (e.g., the controller configuration examples in FIGS. 4, 44, 83, and 84), the local computing device, and / or the electronic circuits within the remote server may include some or all of the capabilities of a computer that communicates with a network and / or directly communicates with other computers. As shown in FIGS. 49 and 50, computer 500 may include a processor 502, a storage device 516, a display or other output device 510, an input device 512, and a network interface device 520, all of which are interconnected via a bus 508. A battery 503 is coupled to and powers the computer. The computer can communicate with a network. Processor 502 represents a central processing unit of any architecture, such as CISC (Complex Instruction Set Computing), RISC (Reduced Instruction Set Computing), VLIW (Very Long Instruction Word), or a hybrid architecture, although a suitable processor can be used. Processor 502 executes instructions and includes the portion of computer 500 that controls the operation of the entire computer. Although not shown in FIGS. 49 and 50, processor 502 typically includes a control unit that organizes data and program storage areas in memory and transfers data and other information among various parts of computer 500. Processor 502 receives input data from input device 512, and network 526 reads instructions (e.g., processor-executable code) 524 and data and stores them in main storage device 504, such as random access memory (RAM), static memory 506, such as read-only memory (ROM), and storage device 516. Processor 502 can provide data to the user via output device 510.

[0106] Although computer 500 is shown as having only a single processor 502 and a single bus 508, the disclosed embodiments are equally applicable to computers that may have multiple processors and to computers that may include multiple buses, some or all of which may perform different functions in different ways from one another.

[0107] Storage device 516 represents one or more mechanisms for storing or holding data. For example, storage device 516 may include computer-readable media 522, such as read-only memory (ROM), RAM, non-volatile storage media, optical storage media, flash memory devices, and / or other machine-readable media. In other embodiments, other suitable forms of storage devices may be used. Although only one storage device 516 is shown, multiple storage devices and many forms of storage devices may exist. Further, although computer 500 is depicted as including storage device 516, this computer may be distributed, for example, across other computers on a server.

[0108] The memory device 516 is executable on the processor 502 to perform the functions described above in connection with the processing of the controller (not shown) and sensor data, display sensor data or instructions based on the sensor data, control various aspects of the smart OPEP to change its operation, or contact third parties or other remotely located resources to provide update information to the remotely located resources or retrieve data from such remotely located resources, and may include a computer-readable medium 522 with instructions 524. In another embodiment, some or all of these functions are implemented by hardware instead of a processor utilization system. In one embodiment, the controller is a web browser, but in other embodiments, the controller may be a database system, a file system, an email system, a media manager, an image manager, or have any other function capable of accessing data items. The memory device 516 may further include additional software and data (not shown) that are not necessary for understanding the present invention.

[0109] The output device 510 is the part of the computer 500 that displays the output to the user. The output device 510 is preferably a liquid crystal display (LCD) which is well-known in the computer hardware art. In other embodiments, a gas or plasma utilization flat panel display or a traditional cathode ray tube (CRT) display may be used in place of the output device 510. In still other embodiments, any suitable display device can be used. Although only one output device 510 is shown, in other embodiments, any number of output devices of different or the same format may exist. In one embodiment, the output device 510 displays a user interface. The input device 512 is a keyboard, mouse or other pointing device, trackball, touchpad, touch screen, keypad, microphone, voice recognition device, or any other suitable mechanism for enabling the user to input data into the computer 500 and operate the above-described user interface. Although only one input device 512 is shown, in another embodiment, any number and any format of input devices may exist.

[0110] The network interface device 520 provides connectivity from the computer 500 to the network 526 via any suitable communication protocol. The network interface device 520 transmits and receives data items via the wireless or wired transceiver 514 to and from the network 526. The transceiver 514 can be any of a number of known wireless or wired transmission systems that can communicate with a cellular frequency, radio frequency (RF), infrared (IR), or other smart device 102 having some or all of the characteristics of the network 526 or the example computers of FIGS. 49 or 50. The bus 508 represents one or more buses, such as USB, PCI, ISA (Industry Standard Architecture), X-bus, EISA (Extended Industry Standard Architecture), or any other suitable bus and / or bridge (also called a bus controller).

[0111] Computer 500 can be embodied using any suitable hardware and / or software, such as a personal computer or other electronic computing device. Computer 500 may be a portable computer, a laptop, tablet or notebook computer, smartphone, PDA, pocket computer, appliance, telephone, and a mainframe computer is an example of another possible form of computer 500. Network 526 can be any suitable network, and this network may support any suitable protocol for communication to computer 500. In one embodiment, network 526 may support wireless communication. In another embodiment, network 526 may support hardwired communication, such as telephone lines or cables. In another embodiment, network 526 may support the Ethernet IEEE (Institute of Electrical and Electronics Engineers) 802.3x standard. In another embodiment, network 526 may be the Internet, and this network may support IP (Internet Protocol). In another embodiment, network 526 may be a LAN or WAN. In another embodiment, network 526 may be a hotspot service provider network. In another embodiment, network 526 may be an intranet. In another embodiment, network 526 may be a GPRS (General Packet Radio Service) network. In another embodiment, network 526 may be any suitable cellular data network or cellular radio network technology. In another embodiment, network 526 may be an IEEE802.11 wireless network. In yet another embodiment, network 526 may be any suitable network or combination of networks. Although one network 526 is shown, in other embodiments any number of networks (of the same or different forms from each other) may exist.

[0112] It should be understood that the various techniques described herein can be implemented in relation to hardware or software, or in combination with both where applicable. Thus, the methods and apparatuses of the present invention disclosed herein, or certain aspects or portions thereof, can take the form of program code (i.e., instructions) embodied in a tangible medium, such as a floppy disk, CD-ROM, hard drive, or any other machine-readable storage medium, and when the program code is loaded into and executed by a machine, such as a computer, the machine becomes an apparatus for implementing the present invention disclosed herein. In the case of program code execution on a programmable computer, the computing device generally includes a processor, a storage medium readable by the processor (including volatile and non-volatile memory and / or storage elements), at least one input device, and at least one output device. One or more programs can execute or be used to execute the processes described in relation to, for example, an API, reusable control device, etc. Such programs can be embodied in a high-level procedural or object-oriented programming language to communicate with a computer system. However, the programs can be embodied in assembly or machine language if desired. In any case, the language is preferably a compiler-type or interpreter-type language, and the language is preferably combined with a hardware implementation example. The exemplary embodiments relate to the use of aspects of the present invention disclosed herein in relation to one or more stand-alone computer systems, but the present invention is not limited thereto and, instead, can be embodied in relation to any computing environment, such as a network or distributed computing environment. Furthermore, aspects of the present invention disclosed herein can be embodied within or across a plurality of processing chips or devices, and the storage devices can be similarly distributed across a plurality of devices. Such devices can include, for example, personal computers, network servers, and handheld devices.

[0113] Providing feedback to the user regarding the user's technique is one feature of Smart OPEP that aids in treatment optimization. One or more sensors, switches, and / or instruments that a controller 158, which can be disposed on or within various embodiments of the Smart OPEP described herein, is in communication with track or control the operation of the Smart OPEP. The controller can store the collected data in memory for later download to a receiving device or transfer the data to the receiving device in real time. Additionally, the controller can perform some processing of the collected data from the sensors or store and transfer the raw data. An RF transmitter and / or receiver module can be associated with the controller provided in the Smart OPEP, whereby the Smart OPEP can communicate in real time or later with a remote handheld or fixed computing device when the Smart OPEP is within the communication range of a communication network to the remote handheld or fixed location computing device. The controller can include one or more of the features of the computer system 500 shown in FIG. 49. Additionally, one or more sensors, switches, or instruments can form a wired or wireless communication environment with the controller.

[0114] To make it easier to understand, when displaying other features of the various smart OPEP embodiments being described, the controller circuit is omitted from some of the figures, but a controller or other processing agent that can manage at least the routing or storage of data from the smart OPEP is envisioned in one variation of these embodiments. In other embodiments, the smart OPEP may not include an on-board processor, and the various sensors, instruments, and switches of a particular embodiment can communicate directly wirelessly with a remotely located controller or other processing device, such as a handheld device or a remote server. One embodiment of the circuitry is shown in FIGS. 83 - 85B. Data collected by the controller or other processing device can be compared to expected or pre-programmed values in local controller memory or other remote locations to provide a basis for feedback on whether the desired performance or treatment is being carried out. If the controller is more complex and sophisticated and includes many of the elements of the computer 500 shown in FIG. 49, this processing may preferably be all local to the smart OPEP. In a more basic controller configuration, the data can be stored on-site or remotely with a date / time stamp for later processing. In one embodiment, the data can further be stamped on-site or remotely with a unique device or patient identifier.

[0115] Feature: Performance Limit Referring to FIG. 35, the patient or HCP may be notified when the pressure characteristics are exceeded. The main purpose of this feature is to ensure patient safety and is a simplified version of the previous feature. For example, OPEP treatment may be used postoperatively, and the patient may need to remain in a state below a certain pressure. The flowchart of FIG. 35 is similar to the flowchart of FIG. 25 but includes only the upper limit. Any of the outputs described above, such as visual, auditory, vibration, or smartphone display, can be used in this feature.

[0116] Feature: Real - Time DFP Feedback The previous feature can inform the user only when the input is high, low, or acceptable. The additional feature provides quantitative real-time feedback on the desired performance characteristics.

[0117] All of the inputs listed in the previous feature can be used for this feature. 10.2.1. Pressure Sensor 10.2.2. Flexure Sensor 10.2.3. Non-Contact Position Sensor 10.2.4. LVDT 10.2.5. Conductive Membrane 10.2.6. Hall Effect Sensor 10.2.7. Light Curtain 10.2.8. Flow Sensor 10.2.9. Potentiometer Vane 10.2.10. Piezoelectric Flexure Sensor 10.2.11. LED / Light Sensor 10.2.12. Proximity Sensor 10.2.13. Accelerometer 10.2.14. Microphone

[0118] The input can be analyzed to determine the following. 10.3.1. Peak and Valley Detection 10.3.2. Average Peak 10.3.3. Average Valley 10.3.4. Amplitude 10.3.5. Average Pressure 10.3.6. True Average Pressure 10.3.7. Frequency

[0119] To display the DFP in real time, a computer device, such as a laptop, smartphone, or tablet, or another separate device equipped with a display is required.

[0120] Feature: DFP History Another feature provides a way for the patient or HCP to review DFP data from a previous session. The DFP data can be displayed over time, and the user can search for and display the data by some time element, such as, but not limited to, day, week, month, year, or all time. This enables the user to quickly visualize trends in performance.

[0121] Feature: Guarantee of proper setting This feature provides the user with feedback regarding proper resistance setting values. In one embodiment, the OPEP device provides five resistance setting values that change the frequency, amplitude, and mean pressure performance. Given a flow rate, increasing the resistance setting value increases the frequency and pressure characteristics. In one embodiment, for example, in the Aeobika® OPEP device IFU, the correct resistance setting value will result in an I:E ratio of 1:3 or 1:4 for 10 - 20 minutes without excessive fatigue. Thus, the input will be used to identify the start and end of the inhalation and exhalation cycles. Some possible inputs include a flow sensor, a pressure sensor, or a microphone.

[0122] A flow sensor may be placed within the mouthpiece and used to determine the I:E ratio. It would be necessary for a single flow sensor placed at location 1 shown in FIG. 36 to be able to measure the flow in both directions. Also, it is possible to use two one - way flow sensors, i.e., one one - way flow sensor located at location 1 for exhalation and one one - way flow sensor located at location 2 shown in FIG. 36 for inhalation.

[0123] The I:E ratio can be calculated using a pressure sensor. When the pressure is negative, the flow is inhalation, and when the pressure is positive, the flow is exhalation. The pressure sensor may be positioned as shown in FIG. 24.

[0124] In a variant embodiment, two microphones may be used to enable the calculation of the I:E ratio, similar to the dual flow sensor shown in FIG. 36. A single microphone can only be used to identify that flow is occurring, and cannot identify whether the flow is inhalation or exhalation.

[0125] To analyze the I:E ratio, it is necessary to determine four time points, namely the start and end of inhalation (T1 and T2) and the start and end of exhalation (T3 and T4). The analysis may follow the logic shown in FIG. 37. When using two sensors, additional logic is required to determine whether the flow is inhalation or exhalation. If sensor 1 is ON and sensor 2 is OFF, the flow is exhalation. If sensor 1 is ON and sensor 2 is ON, the flow is inhalation.

[0126] The output of this feature provides the user with a recommendation to either increase the resistance, decrease the resistance, or leave the resistance setting unchanged. The output component may be embedded within the device, and this output may be visual, auditory, tactile, or any combination thereof, as shown in FIGS. 27 and 28. Alternatively, the output may be shown on a separate device, such as a smartphone, or other computer device or screen.

[0127] Feature: Setting value recommendation based on previous data This feature will analyze the previous DFP data to provide setting value recommendations. This feature can calculate the I:E ratio for each breath and then calculate the average I:E ratio for the session. Based on the average I:E ratio, this feature will make setting value change recommendations using the logic shown in FIG. 37 and / or described above.

[0128] Feature: Appropriate technology This feature provides training and guidance to the user on the appropriate techniques for performing IFU-based OPEP operations and it is advisable to update this feature for other devices. In one embodiment, this feature can take the form of an app and will communicate with the OPEP device via BTLE (see Figure 4 for details).

[0129] Appropriate OPEP operations depend on several variables such as the I:E ratio, frequency, pressure, and set values. These inputs have been described above.

[0130] Ideal OPEP operations follow these steps: inhaling slowly, taking a breath deeper than normal but not filling the lungs, pausing the breath, and then exhaling actively. To analyze the first step, the app needs to learn the user's breathing pattern. This is done during the initial setup or training session and should be re-evaluated if the user's performance changes. To start, the user inhales normally through the device, with the aim of calculating these baseline inspiratory pressures, or IP tidal or tidal volume (TV). Next, the user inhales fully through the device to calculate the maximum inspiratory pressure, or IP max or inspiratory capacity (IC). The app then calculates the target inspiratory pressure (IP target ) or volume for step #1, and this IP target is more than IP tidal (or tidal volume) and less than IP max (or inspiratory capacity). The starting point for IP target (i.e., the target inspiratory volume) is the average of IP tidal and IP max (or TV and IC).

[0131] In the next step, pause the breath for 2 - 3 seconds. Breath pause = T3 - T2.

[0132] Next, the user breathes out actively but not forcefully. The frequency and pressure should be within the target range, and the exhalation should last 3 - 4 times longer than the inhalation. Breathing out actively is a subjective description of the OPEP operation. Therefore, the app calculates the frequency, average pressure, and I:E ratio in real time and uses this information and data to determine whether the proper technique is being achieved.

[0133] The output of this guiding feature will guide the user towards the correct OPEP technique based on the user's breathing pattern and specific performance characteristics. If any of the above steps are not performed as per the character, the app will give suggestions to change the user's technique. For example, if the user does not pause their breath before exhaling, the app will provide a reminder. In another example, the app may suggest that the user increase their flow rate because the average pressure is too low to stay within the tolerance limit. For the app to declare that the user is "trained", the user may be required to demonstrate the proper OPEP operation several times. The app may also play the sound of the proper OPEP operation, which can help the user breathe out actively. The app may further include a training video explaining the proper technique and examples of people performing the proper OPEP operation. The app may notify the user's healthcare provider (HCP) if the proper technique has not been completed.

[0134] Feature: Session Support In addition to the guiding features, the smart OPEP device can assist the user in following an accurate treatment plan. The session support features assist the user or HCP in completing an OPEP session. For first-time users, the OPEP session can be confusing and complex. The user has to count their breaths, remember the proper technique, remember when to do "huffing" coughs, etc. For example, the IFU for the Aerobika® OPEP device recommends the following steps: performing 10 - 20 OPEP maneuvers or breaths, doing 2 - 3 "huffing" coughs after at least 10 breaths, repeating regularly 2 times a day for 10 - 20 minutes and increasing up to 3 - 4 times a day if necessary.

[0135] Using the input defined above, this feature counts the number of breaths and provides the user with feedback on either the remaining or completed number of breaths. The app then reminds the user to do a "huffing" cough after the appropriate number of breaths and then repeats the breath counting / huffing cough cycle for 10 - 20 minutes. The user may input the total number of breaths to complete the entire session time as the goal and to track progress. The session support features also track the number of sessions per day, which can be used to determine the user's progress or quality of life.

[0136] Feature: Quality of Life (QoL) Score This feature converts quantitative data into qualitative data, which is easy for users, HCPs, or payers to understand. Three steps are required, namely, obtaining the user's quality of life (QoL) score, correlating past DFP performance with the QoL score, and predicting the QoL score based on DFP performance trends. Using various inputs, the QoL score can be calculated, and this QoL score will be correlated with DFP performance. The inputs may be both qualitative and quantitative. The algorithm can be created or adjusted to fit various disease forms. Some examples of QoL inputs are the St. George's Respiratory Questionnaire for COPD, a simplified questionnaire, the user's diary, the number of steps per day, and / or the number of hours the user is sitting.

[0137] The aim is to calculate a QoL score that changes over time when the user's condition improves or worsens. Initially, the user completes a questionnaire, and the baseline QoL score is computer-calculated. The user's diary is scanned for keywords such as good day, bad day, cough, shortness of breath, etc., and the QoL score is adjusted based on the number of times the keyword appears (i.e., good day = +1, shortness of breath = -1). The application may also calculate the number of steps taken per day (or integrate with another app or device, such as a FitBit) and use this information to adjust the QoL score.

[0138] Once the QoL score is generated, the app determines the relationship between the QoL score and the measured values in the correlation history of DFP performance. This requires a period of time when the app is "learning" how the two variables are related. In the following example, after one week of OPEP sessions (2x / day) and daily QoL inputs from the user, the following linear regression equation is defined as QoL = 5.6 × MP - 6.8, as shown in Figure 39. The linear regression equation is also calculated for each of the other measurable items, and the QoL score is predicted using the equation (y = mx + b) with the highest "m" multiplier. For example, if the frequency / QoL equation is QoL = 1.2F + 5.2, it is shown that for this particular user, changes in frequency are less likely to indicate changes in QoL than changes in mean pressure. A flowchart regarding this feature is shown in Figure 40. Outputs regarding this feature include current and past QoL scores, suggestions for improving the QoL score, the relationship between the measurable score and the QoL score and the linear regression results, encouragement if the QoL score decreases, and / or notification to the HCP if the QoL score decreases.

[0139] Feature: Appliance status This feature provides the user with feedback regarding the appliance itself. There are several options, and such options include notifying the user, HCP, or payer that the appliance needs to be replaced. This can take the form of a reminder in the app or lock out features until a new lot number or serial number is entered. The feedback may further include informing the user of the point in time when the device needs to be cleaned. The cleaning notification may preferably be based on the number of sessions conducted between cleanings and / or changes in the performance of the appliance over time.

[0140] Feature: Stakeholder update A stakeholder is defined as an individual or organization, apart from the patient's next of kin who are interested in the patient's medical condition, treatment, and progress. A stakeholder may be the patient's physician, respiratory therapist, hospital, or insurance company. Some examples of stakeholder updates include updating an insurance company with the user's usage data to monitor patient compliance and / or updating HCPs with the patient's progress since the last visit, usage data, and QoL scores.

[0141] Feature: Active OPEP Referring to FIG. 41, an apparatus is disclosed that automatically adjusts a resistance to keep selected performance characteristics (e.g., pressure (amplitude) and / or frequency) within a desired range. The range and / or performance characteristics to be controlled may be pre-programmed in the apparatus or input by the user as described above. The microprocessor receives data from the sensor and determines how the algorithm should adjust the apparatus. The microprocessor then gives a command to motor 190, and the motor physically implements the adjustment of a control component, such as valve seat 148 or the orientation of the chamber inlet. Encoder 192 checks the position of the motor and returns that information to the microprocessor. This improves user compliance, as all that is required of the user is a breath into the apparatus. The apparatus automatically sets and controls the resistance setting to achieve the desired treatment. Another option is to program the algorithm with frequency or pressure variations when some investigation has shown that it would be beneficial.

[0142] Feature: Lung health Referring to FIG. 42, one embodiment includes a flow sensor that can turn off vibrations and evaluate the health of a patient's lungs by enabling the instrument to operate like a spirometer. The flow sensor needs to be able to measure flow in both directions (inhalation and exhalation). The algorithm uses the flow being measured to generate the flow-volume loop shown in FIG. 42. From the FV loop, various parameters can be calculated and fed back to the patient.

[0143] The invention has been described with reference to the preferred embodiments, and those skilled in the art will recognize that changes in form and detail can be made without departing from the spirit and scope of the invention. Accordingly, the foregoing detailed description is intended to be illustrative rather than limiting, and the scope of the invention is defined by the claims, which include all equivalents thereof.

Claims

1. A vibrating expiratory positive pressure device, having a mouthpiece that defines a longitudinal axis and has an end port, having a housing connected to the mouthpiece and having a top surface, at least a portion of the top surface being longitudinally spaced from the end port and the at least a portion constituting a visual plane that is visible to the eyes of a user who has placed the end port in their mouth, having a feedback array disposed on the visual surface, the feedback array extending diagonally across the visual surface, the vibrating expiratory positive pressure device.

2. The vibrating expiratory positive pressure device according to claim 1, wherein the visual surface is substantially horizontal when the housing is positioned in the use position with the end port placed in the user's mouth.

3. The vibrating expiratory positive pressure device according to claim 1, wherein the feedback array consists of a plurality of spaced-apart lights.

4. The vibrating expiratory positive pressure device according to claim 3, wherein the feedback array is substantially linear.

5. The vibrating expiratory positive pressure device according to claim 4, wherein the feedback array extends longitudinally and transversely.

6. The vibrating expiratory positive pressure device according to claim 5, wherein the feedback array intersects the longitudinal axis.

7. The vibrating expiratory positive pressure device according to claim 3, wherein the plurality of lights includes a first outermost light located closest to the end port and a second outermost light located farthest from the end port.

8. The first outermost light is illuminated with a first color indicating user input below a predetermined tolerance range, the second outermost light is illuminated with a second color indicating that the user input exceeds the predetermined tolerance range, and at least one of the plurality of lights positioned between the first outermost light and the second outermost light is illuminated with a third color indicating that the user input is within the predetermined tolerance range, the vibrating expiratory positive pressure device according to claim 7.

9. The vibrating expiratory positive pressure device according to claim 8, wherein the first color is blue, the second color is red, and the third color is green.

10. The outermost first lamp consists of a pair of outermost first lamps adapted to be illuminated with the first color, the outermost second lamp consists of a pair of outermost second lamps adapted to be illuminated with the second color, and at least one of the plurality of lamps positioned between the outermost first lamp and the outermost second lamp consists of at least two intermediate lamps. The oscillating expiratory positive pressure device according to claim 8.

11. The at least two intermediate lamps consist of four intermediate lamps. The oscillating expiratory positive pressure device according to claim 10.

12. The oscillating expiratory positive pressure device according to claim 1, further comprising a direction indicator positioned below the feedback array.

13. The direction indicator includes a first arrow positioned below one end of the feedback array and a second arrow positioned below the other end of the feedback array. The oscillating expiratory positive pressure device according to claim 12.

14. The arrows face each other. The oscillating expiratory positive pressure device according to claim 13.

15. The outermost first lamp is different from the first color and is adapted to be illuminated with a fourth color indicating a low power source. The oscillating expiratory positive pressure device according to claim 8.

16. The outermost first lamp is different from the fourth color and is adapted to be illuminated with a fifth color indicating that battery exhaustion is associated with the oscillating expiratory positive pressure device. The oscillating expiratory positive pressure device according to claim 15.

17. The outermost first lamp is adapted to be illuminated with a fourth color indicating that the oscillating expiratory positive pressure device is not associated with a memory type storage device. The oscillating expiratory positive pressure device according to claim 8.

18. The plurality of spaced-apart lamps consist of a plurality of spaced-apart LEDs. The oscillating expiratory positive pressure device according to claim 3.

19. The oscillating expiratory positive pressure device according to claim 8, further comprising a quantity descriptor attached to the visual surface adjacent to the feedback array.

20. The quantity descriptor includes a first quantity descriptor attached to the visual surface adjacent to the outermost first lamp and a second quantity descriptor attached to the visual surface adjacent to the outermost second lamp. The oscillating expiratory positive pressure device according to claim 19.

21. The first quantity descriptor is "LOW" and the second quantity descriptor is "HIGH". The oscillating expiratory positive pressure device according to claim 20.

22. The oscillating expiratory positive pressure device according to claim 20, further comprising a third quantity descriptor attached to the visual surface adjacent to at least one of the plurality of lights located between the first outermost light and the second outermost light.

23. The oscillating expiratory positive pressure device according to claim 22, wherein the third quantity descriptor is "GOOD" or "OK".

24. A method of using an oscillating expiratory positive pressure device, comprising: exhaling through an end port into a mouthpiece defining a longitudinal axis, thereby generating an exhalation flow rate and pressure; viewing a feedback array provided on the top surface of a housing coupled to the mouthpiece, the feedback array extending diagonally across the visual surface; illuminating at least a portion of the feedback array to indicate whether the exhalation flow rate or pressure is within a predetermined acceptable range or outside the predetermined acceptable range.

25. The method according to claim 24, wherein the visual surface is substantially horizontal.

26. The method according to claim 24, wherein the feedback array comprises a plurality of spaced-apart lights.

27. The method according to claim 26, wherein the feedback array is substantially linear.

28. The method according to claim 27, wherein the feedback array extends in a longitudinal direction away from the user and in a left-right lateral direction.

29. The method according to claim 28, wherein the feedback array intersects the longitudinal axis.

30. The method according to claim 26, wherein the plurality of lights includes a first outermost light closest to the user and a second outermost light farthest from the user.

31. The step of illuminating at least a portion of the feedback array to indicate whether the expiratory flow rate or pressure is within a predetermined acceptable range or outside the predetermined acceptable range includes illuminating the first most distal lamp with a first color when the expiratory flow rate or pressure is below the predetermined acceptable range, illuminating the second most distal lamp with a second color when the expiratory flow rate or pressure is above the predetermined acceptable range, and illuminating at least one of the plurality of lamps located between the first most distal lamp and the second most distal lamp with a third color when the expiratory flow rate or pressure is within the predetermined acceptable range, the method according to claim 30.

32. The vibration type expiratory positive pressure device according to claim 31, wherein the first color is blue, the second color is red, and the third color is green.

33. The method according to claim 31, wherein the first most distal lamp consists of a pair of first most distal lamps, the second most distal lamp consists of a pair of second most distal lamps, and the at least one of the plurality of lamps located between the first most distal lamp and the second most distal lamp consists of at least two intermediate lamps.

34. The method according to claim 33, wherein the at least two intermediate lamps consist of four intermediate lamps.

35. The method according to claim 24, further comprising the step of visually observing a direction indicator located below the feedback array.

36. The method according to claim 35, wherein the direction indicator includes a first arrow located below one end of the feedback array and a second arrow located below the other end of the feedback array.

37. The method according to claim 36, wherein the arrows face each other.

38. The method according to claim 31, further comprising the step of illuminating the first most distal lamp with a fourth color different from the first color when the power source falls below a predetermined power level.

39. The method according to claim 31, further comprising the step of illuminating the first most distal lamp with a fifth color different from the fourth color when the power source is off.

40. The method according to claim 31, further comprising the step of illuminating the first most distal lamp with a fourth color when the vibration type expiratory positive pressure device is not associated with a memory type storage device.

41. The method according to claim 26, wherein the plurality of spaced-apart lamps comprise a plurality of spaced-apart LEDs.

42. The method according to claim 31, further comprising the step of visually observing a quantity descriptor attached to the visual surface adjacent to the feedback array.

43. The method according to claim 42, wherein the quantity descriptor includes a first quantity descriptor attached to the visual surface adjacent to the first outermost lamp and a second quantity descriptor attached to the visual surface adjacent to the second outermost lamp.

44. The method according to claim 43, wherein the first quantity descriptor is "LOW" and the second quantity descriptor is "HIGH".

45. The method according to claim 43, further comprising a third quantity descriptor attached to the visual surface adjacent to at least one of the plurality of lamps located between the first outermost lamp and the second outermost lamp.

46. The method according to claim 45, wherein the third quantity descriptor is "GOOD" or "OK".

47. A respiratory therapy device, having a mouthpiece that defines a longitudinal axis and has end ports, having a housing connected to the mouthpiece and having a top surface, at least a portion of the top surface being longitudinally spaced from the end ports and constituting a visual plane that is visible to the eyes of a user who has placed the end ports in their mouth, having a feedback array disposed on the visual surface, the feedback array extending diagonally across the visual surface. A respiratory therapy device.

48. The respiratory therapy device according to claim 47, further comprising a drug delivery device.

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