Patent ID: 12214252

DETAILED DESCRIPTION OF THE PRESENTLY PREFERRED EMBODIMENTS

It should be understood that the term “plurality,” as used herein, means two or more. The term “coupled” means connected to or engaged with, whether directly or indirectly, for example with an intervening member, and does not require the engagement to be fixed or permanent, although it may be fixed or permanent. It should be understood that the use of numerical terms “first,” “second,” “third,” etc., as used herein does not refer to any particular sequence or order of components. It should be understood that the term “user” and “patient” as used herein refers to any user, including pediatric, adolescent or adult humans, and/or animals.

The term “smart” refers to features that follow the general format of having an input, where information is entered into the system, analysis, where the system acts on or modifies the information, and an output, wherein new information leaves the system. The phrase “performance characteristics” refers to measurements, such as frequency or amplitude, which quantify how well a device is functioning. Frequency is defined as the number of oscillations in one second, however, during a typical OPEP maneuver the rate of oscillations may not be consistent. Accordingly, frequency may be defined as the inverse of the time between oscillations (1/T), measured in Hz. This second definition calculates the frequency of each oscillation and is averaged over a period of time. Max pressure is the maximum pressure for each oscillation, typically measured in cmH2O. Min pressure is the minimum pressure for each oscillation, typically measured in cmH2O. Upper pressure is the average of the max pressures for a given time period, for example one second. Lower pressure is the average of min pressures for a given time period, for example one second. Amplitude is the difference between the upper and lower pressures. Mean pressure is the average of the upper and lower pressures. True mean pressure is the average of the entire pressure waveform for a given time period. The true mean pressure is typically lower than the means pressure because the typical pressure wave generated is not uniform, i.e., is skewed towards the min pressure.

Referring toFIG.1, an OPEP pressure waveform is shown with various performance characteristics.FIG.2illustrates in block diagram form an OPEP device, illustrated as the dashed box that encloses the internal components, configured with smart capabilities. One exemplary OPEP device2is the Aerobika® OPEP device, shown inFIGS.47and48, available from Monaghan Medical Corporation, Plattsburg, New York, whileFIGS.4,24and27-30show a modified OPEP device. Various OPEP devices and structures are further disclosed in U.S. Pat. No. 8,985,111, issued Mar. 24, 2015 and entitled Oscillating Positive Expiratory Pressure Device, U.S. Pat. No. 8,539,951, issued Sep. 24, 2013 and entitled Oscillating Positive Expiratory Pressure Device, U.S. Pat. No. 9,220,855, issued Dec. 29, 2015 and entitled Oscillating Positive Expiratory Pressure Device, U.S. Pub. 2012/0304988, Published Dec. 6, 2012 and entitled Oscillating Positive Expiratory Pressure Device U.S. Pub. 2015/0297848, Published Oct. 22, 2015 and entitled Oscillating Positive Expiratory Pressure Device, and U.S. Pub. 2015/0053209, Published Feb. 26, 2015 and entitled Oscillating Positive Expiratory Pressure Device, the entire disclosures of which are hereby incorporated herein by reference. It should be understood that other OPEP devices may be configured with other components that create pressure oscillations.

Referring toFIGS.47and48, a user, such as a patient, interacts with the OPEP device2via a mouthpiece4. The OPEP device includes a housing6enclosing a mouthpiece chamber48, a chamber14a,14b, a chamber inlet16in communication with the mouthpiece, and one or more chamber outlets18. Typically, OPEP devices permit the user to inhale and exhale, although some devices may permit exhalation only. The housing6has a front section8, a rear section10, and an inner casing12, which may be separable so that the components contained therein can be periodically accessed, cleaned, or reconfigured, as required to maintain the ideal operating conditions.

The OPEP device2also includes an inhalation port20, a one-way valve22, an adjustment mechanism24, a restrictor member26, a vane28, and a variable nozzle30, or vale assembly. As seen inFIGS.47and48, the inner casing12is configured to fit within the housing6between the front section8and the rear section10, and partially defines the chamber14a, b, including a first chamber and a second chamber. First and second chamber outlets18are formed within the inner casing. The OPEP device2may include an adjustment mechanism24, with actuator25, adapted to change the relative position of a chamber inlet16. A user is able to conveniently adjust both the frequency and the amplitude of the OPEP therapy administered by the OPEP device2without opening the housing and disassembling the components of the OPEP device. For example, the OPEP device may have a plurality of settings, for example five (5), including a high, medium and low.

The OPEP device2may be adapted for use with other or additional interfaces, such as an aerosol delivery device. In this regard, the OPEP device2is equipped with an inhalation port20in fluid communication with the mouthpiece4. As noted above, the inhalation port may include a separate one-way valve22configured to permit a user of the OPEP device2both to inhale the surrounding air through the one-way valve22and to exhale through the chamber inlet16, without withdrawing the mouthpiece4of the OPEP device2from the user between periods of inhalation and exhalation. In addition, the aforementioned commercially available aerosol delivery devices may be connected to the inhalation port20for the simultaneous administration of aerosol therapy (upon inhalation) and OPEP therapy (upon exhalation).

The exhalation flow path40begins at the mouthpiece4and is directed through the mouthpiece chamber48toward the chamber inlet16, which in operation may or may not be blocked by the restrictor member26, or valve assembly which may include a valve seat and butterfly valve. After passing through the chamber inlet16, the exhalation flow path40enters the first chamber14aand makes a 180° turn toward the variable nozzle30. After passing through an orifice of the variable nozzle, the exhalation flow path enters the second chamber14b. In the second chamber14b,the exhalation flow path40may exit the second chamber14b, and ultimately the housing6, through at least one of the chamber outlets18. It should be understood that the exhalation flow path40identified by the dashed line is exemplary, and that air exhaled into the OPEP device2may flow in any number of directions or paths as it traverses from the mouthpiece4to the outlets18.

Referring toFIGS.52A-56, a first embodiment of an adapter400and user interface/control module408is shown. In general, the adapter400includes a body402, a conduit404extending from the body402, and a plug406positioned along and inserted into the conduit404. The user interface/control module408, which may include an instrument for measuring pressure positioned at an outlet403of the conduit404.

The body402may be sized and shaped for integration with existing OPEP devices, for example, as shown inFIGS.51,53,55and59, with the mouthpiece4of the OPEP device2. For example, the body402may include 22 mm ISO male/female conical connectors410,412shaped and sized to connect to a port414on the OPEP device2and an insert portion416of the mouthpiece4respectively. In operation, the mouthpiece4is disengaged from the OPEP device2, and the adapter is disposed, 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 port20.

As shown inFIGS.52A-56, extending from the body402is a conduit404configured to transmit a pressure from within the OPEP device2to the user interface/control module408. An inlet405permits a pressure within the body402to be transmitted into the conduit404. As shown, the conduit404extends away from the body402, then angles alongside the OPEP device2, thereby maintaining the portability and ergonomics of the OPEP device2, and avoiding the need for lengthy tubing or additional attachments.

The user interface/control module408is positioned at an outlet403of the conduit404. It should be appreciated, however, that a portion of the conduit404could extend into a passageway in the user interface/control module408, or other instrument for measuring pressure. Preferably, the user interface/control module408may include one or more of a numerical, color, shape, or other visual indicia, or one or more of a sound or other auditory indicia, or a combination of one or more of each of a visual indicia and an auditory indicia. In one of the exemplary embodiments shown, the user interface/control module408includes a visual display, such as an array of LED lights150and a display screen420, which may display various data, as further explained below. Preferably, the user interface/control module408is positioned relative to the respiratory treatment device such that the indicator and indicia are visible to the user during treatment. As shown in the exemplary embodiment inFIGS.51and55, the user interface/control module408is positioned relative to the respiratory treatment device in the form of an OPEP device2such that the visual display420are positioned adjacent a top of the device and are viewable to a user of the OPEP device2during treatment. Referring toFIG.59, the user interface/control module408is positioned along the side of the OPEP device2, but with the visual display420facing the user.

The plug406is insertable by press-fit in and/or along the conduit404at a point where the conduit404angles alongside the OPEP device2. In one embodiment, the plug may not be removed, but may be made of a self-scaling material, such as a silicone material, allowing a needle or other similar instrument to be inserted and removed for cleaning purposes while maintaining a seal. In another embodiment, the plug may be periodically removed for cleaning of the adapter400. As shown inFIG.52B, the plug406includes a cutout409that may be aligned with a passage411in the conduit404. When the plug406is inserted into the conduit404such that the cutout409is partially or completely aligned with the passage411, a pressure stabilizing orifice407is formed in the conduit404. The pressure stabilizing orifice407is configured to dampen oscillations in the pressures transmitted from the OPEP device2to the user interface/control module408.

The size and shape of the pressure stabilizing orifice407may be selectively adjustable by rotating the plug406relative to the passage411, thereby increasing or decrease the amount of damping. While the pressure stabilizing orifice407is shown as being adjustable, it should be appreciated that the size and shape of the pressure stabilizing orifice407may be fixed. Furthermore, it should be appreciated that the pressure stabilizing orifice407may be positioned anywhere along the conduit404between the body402and the user interface/control module408. However, in order for the pressure stabilizing orifice407to effectively dampen oscillations in the pressures transmitted from the OPEP device2to the user interface/control module408, the cross-sectional area of the pressure stabilizer orifice407should be less than a cross-sectional area of the conduit404along the entire length of the conduit404. In this embodiment, the pressure stabilizer orifice407has a diameter of 0.5 mm to 1.5 mm, or a cross-sectional area between 0.196 mm2 and 1.767 mm2. Preferably, the pressure stabilizer orifice507has a diameter of 0.6 mm to 0.9 mm, or a cross-sectional area between 0.283 mm2 and 0.636 mm2.

Referring toFIGS.66Aand B,68-74B and79-83, another embodiment of an adapter600,900and user interface/control module608,908is shown. In general, the adapter600,900includes a T-connector620configured with a cylindrical tube622defining a flow channel624. The tube has first and second ends626,628, each configured as tubular portions, and a port630communicating with the flow channel between the first and second ends. The first end626may have a smaller outer diameter than the second end, and is shaped and dimensioned to be received in a tubular portion632of the OPEP, while the second end628is shaped and dimensioned to receive a tubular portion634of the mouthpiece4. The port has a cylindrical body636and a rim portion638with an upper face640. A circumferential groove642is formed in the face. The rim portion further defines a peripheral groove644extending around a circumference of the cylindrical body. A plurality of tabs646extend radially outwardly from the rim portion, with the tabs have a bottom tapered leading edge648, or ramp, to promote a sliding engagement with the control module608. A through opening650extends through the rim portion adjacent one side of the adapter, as shown inFIG.76B.

A flexible membrane660includes an annular rim662having an upper flat face664, and a downwardly extending ridge668. The ridge is shaped and dimensioned to be received in the circumferential groove642of the port, so as to form a hermetically sealed (airtight) engagement therewith. The membrane660further includes an annular hinge portion/bellows670, or thin J-shaped wall connected to a central cylindrical body portion672. The membrane is preferably made of silicone rubber, for example Silopren silicone rubber available from Mometive. The body672has a thickness, e.g., 2.5 mm, such that the body has a sufficient mass relative to the bellows portion, having a thickness of 0.30 mm, which provides better feedback to a control module. A tether678extends downwardly from the rim at a spaced location from the wall. The tether has a tapered nose portion680and an annular catch682defining a shoulder. The tapered nose portion facilitates insertion through the opening650, with the tether being pulled through the opening650until the shoulder of the catch engages an underside of the rim. The membrane660is moveable from a first, engaged position where the ridge668is inserted into the groove642, and a second, disengaged position, where the ridge is removed from the groove, for example to allow the underside of the membrane and interior of the T-connector to be washed or cleaned. The tether678maintains a connection between the membrane and T-connector when the membrane is moved between the first and second positions. The bottom side674of the membrane is in fluid communication with the flow channel624of the T-connector, while an opposite top side676defines in part a chamber684.

Referring toFIGS.66Aand B,68-74B and79-84, the control module608,908includes a housing700,910having upper and lower casings704,702,912,914. The lower casing702,912includes a chamber portion706overlying the top side676of the membrane, with the top side and chamber portion defining the chamber684. The chamber portion706has a generally circular, or cylindrical shape, and includes a top wall708and a first circumferential wall710extending downwardly from the top wall, with the top wall and first circumferential wall defining in part the chamber. A second circumferential wall712is disposed radially outwardly from the first wall and is connected thereto with a web portion714having a plurality of openings. A plurality of corresponding tabs716(shown inFIG.71) extend radially inwardly from a bottom edge of the second wall, with spaces718defined between the tabs. In operation, the housing700is disposed over the port630and membrane660, with the tabs638on the port being aligned with the spaces718. The housing700,910is pressed against the membrane660and rotated such that the tabs716are biased by the tabs638on the port (shown as 5 on each), pressing the bottom of the web714against the top surface of the membrane rim662as the rib/ridge668is pressed into the groove642thereby forming the hermetic seal and defining the interior chamber684between the membrane and chamber portion of the housing. The control module608,908may be disconnected in a reverse manner by rotating the control module relative to the port until the tabs638are aligned with the spaces718, whereinafter the two components may be moved axially away from each other. After separation, the membrane660may also be moved away from the port to allow for washing/cleaning of the membrane and T-connector, while being maintained in connection the T-connector via the tether.

The chamber portion further includes an annular flange (FIG.71), or travel/stop member720, that extends downwardly from the top wall and is disposed over the membrane. The annular flange does not extend 360 degrees, but rather has a mouth portion, or opening, positioned adjacent a sensor port724, such that that air within the confines of the annular flange volume may escape to other portions of the chamber, for example when the membrane engages the stop member. The stop member720is spaced apart from the top side676of the central body portion thereof. The stop member limits the upper travel of the central body portion during use. The lower casing704extends longitudinally over the top of the OPEP device, with the housing700spaced above the flow channel and cantilevered rearwardly from the adapter600. A longitudinal axis of the oscillating positive expiratory pressure device, orthogonal to the flow channel624, is configured to extend through the housing700during use. Vent holes722may be formed in bottom wall thereof to provide cooling for electronic components housed therein.

A port724is in fluid communication with the interior chamber. In one embodiment, a pressure sensor730is coupled to the port, for example by pressing the sensor against a seal728, e.g., O-ring, with an input portion726of the sensor being in fluid communication with the interior chamber. The upper casing704,914is releasably coupled to the lower casing702,912in one embodiment, for example with fasteners732, with the upper casing pressing the sensor730against the seal. A circuit board740,940and battery742, together with the pressure sensor730, are housed in the lower and/or upper casing, which define an interior space in the housing. The user interface/control module608includes a visual display, such as an array (one or more) of LED lights750, a micro USB port422, an SD-card port424and a switch (on/off)430. In the embodiment ofFIGS.79-83, the control module includes an accelerometer930, disposed on and integrated into the circuit board940.

One suitable accelerometer is an MEMS Accelerometer Part No. MMA8452Q available from NXP Semiconductor, for example. The accelerometer may be used instead of the switch430, or in combination therewith. Preferably, the user interface/control module608is positioned relative to the respiratory treatment device such that the indicator and indicia are visible to the user or care giver during treatment.

Referring to another embodiment shown inFIG.77, the T-connector includes a curved wall780extending below the port. The curved wall defines a second chamber782in combination with the lower side674of the membrane660. A damping orifice784extends through the curved wall and provides fluid communication between the flow channel624and the second chamber782. In one embodiment, the damping orifice784has a diameter in the range of 0.5 to 1.5 mm. In this way, first and second chambers684,782are defined on opposite sides of the membrane, with the first chamber being hermetically sealed, and with the second chamber782being in fluid communication with the flow channel via the damping orifice.

Referring toFIGS.53-56, during administration of OPEP therapy, an oscillating back pressure is transmitted to the user of the OPEP device, which is received by the user at the mouthpiece. When the adapter and user interface/control module408are connected to such an OPEP device, for example the OPEP device2, the oscillating pressure is transmitted from within the body402to user interface/control module408through the conduit404. The oscillations in the pressure are dampened, however, by the pressure stabilizing orifice407, as the flow of air along the conduit404through the pressure stabilizing orifice407is restricted. After the pressure has been dampened by the pressure stabilizing orifice407, the pressure is received and measured by the user interface/control module408, which in turn provides the user with a visual indication of the pressure achieved during administration of OPEP therapy. This allows the user or caregiver to monitor the treatment regimen or therapy to ensure that the appropriate pressures are achieved for the prescribed period of time. In some instances, a treatment regimen or therapy alternating between exhalation at a high pressure for a predetermined period of time and exhalation at a low pressure for a predetermined period of time may be desirable. A visual or auditory indication of the pressure achieved during treatment will allow the user or caregiver to determine the level of compliance with the prescribed treatment regimen or therapy. Various components of the OPEP and adapter are disclosed in U.S. Publication No. US2015/0224269A1, published Aug. 13, 2015, the entire disclosure of which is hereby incorporated herein by reference.

The shaded area50inFIG.2represents the internal volume, defined for example by the mouthpiece chamber48, which becomes pressurized when the valve mechanism closes. The shaded area outside of the OPEP device boundary represents the “smart” features that include three operations: input, analysis and output. The input may come from the high pressure zone50as shown inFIG.2, such as the adapter, although it may originate from another part of the device depending on the measurement being taken or registered.

Inputs

The term “input” refers to any information that enters the smart OPEP system, and may take the form of raw data from a sensor, a command to start a process 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 inFIGS.3and4, a pressure sensor52generates an electrical signal as a function of the pressure in the system, or chamber48. The pressure sensor may be used to calculate any of the performance characteristics referred to above, as well as to evaluate the user's technique. Referring toFIGS.3,4,43A and43B, sensor assembly54may include a housing202for a pressure sensor52placed on a printed circuit board (PCB), along with a BTLE module56, a processor (e.g., microprocessor)60, LED indicator154, memory, wireless communication capabilities and a battery58, or solar aided charge, and may communicate with an output component, for example a user's (patient, caregiver and/or other authorized user) computing device, such as a mobile device62, including a smart phone or tablet computer (as shown inFIG.30). The assembly may be configured as a removable control module608,908, shown inFIGS.66A-69and79-84. A single pressure sensor52may provide all of the measurement requirements. The pressure sensor may be a differential, absolute or gauge type of sensor. The sensor assembly is coupled to the OPEP device, with a cover64disposed over the assembly. The input component is in considered to be in “communication” with the chamber48if it is able to sense or measure the pressure or flow therein, even if the input component is separated from the interior of the chamber, for example by a membrane or other substrate (see, e.g.,FIGS.60,61and68). The input component is operative to sense a flow and/or pressure and generate an input signal correlated to the flow or pressure.

Referring toFIGS.5A-G, various flow sensors are shown that generate an electrical signal as a function of the airflow70in the system. A flow sensor may be used to calculate the frequency, as well as evaluate the user's technique. The flow sensors may include incorporating a venturi78into the shape of the mouthpiece chamber (FIG.5A), incorporating pitot tubes72, which compare pressure generated by flow stagnation at the entrance of the pitot tube to that of the surrounding fluid and determine the fluid velocity (FIG.5B), or using sound transmitters/receivers74to measure the time it takes sound to travel from transmitter 1 (74) to receiver 2 (80), and then from transmitter 2 (80) to receiver 1 (74) (FIG.5C) and calculating the flow based on the different in time being proportional to the flow velocity. Alternatively, as shown inFIG.5D, air flow causes displacement in a magnetic component82, which in turn changes the inductance of a coil84. The inductance of the coil is related to displacement, which may be correlated to flow rate. A biasing spring86(e.g., tension or compression), may be provided to return the magnet to the “zero-flow” position when no flow is present. Referring toFIG.5E, air flow cause a vane88to move that changes the resistance of a potentiometer90, which is related to flow rate. Again, a biasing spring92(e.g., torsion) may be included to return the vane to the “zero-flow” position when no flow is present. Referring toFIG.5F, a vane94, having for example a plurality of blades, rotates in response to a flow, with the speed of the rotation shaft96correlated to the proportional flow rate. Referring toFIG.5G, flow70passes over a heater wire98, which then begins to cool. More current is passed through the wire to maintain a constant temperature, with the amount of measured current correlated to the flow rate.

Referring toFIGS.43Aand B,68and82, the control module54,608,908is not in fluid communication with the internal volume, e.g., mouthpiece chamber48or flow channel624, or the OPEP device, but rather is separated by flexible membrane200,660, which moves in response to changes in pressure within the device, for example the chamber48or flow channel624. In this way, the control module54,608is in communication with the chamber48or flow channel624via pulsations from the membrane200,660, but the control module54,608,908is not in fluid communication with the chamber48or flow channel624.

In this way, the OPEP device, or housing, may be cleaned without damaging the electronic components, and those components also are not in fluid communication with the user's inspiratory and/or expiratory breath or flow. When the control module is removed, or moved to an uninstalled position, the flexible membrane200remains attached to the housing6, and the membrane660remains attached to the T-connector620, for example with the tether, even if the membrane is moved to an uninstalled position.

At rest, the pressure in the OPEP chamber48,14a,14b, is atmospheric or ambient. The pressure (P) in the flow channel624, and the first and second chambers684,782are same. As pressure in the chamber or flow channel increases, an upward/outward force is applied to the membrane200,660, causing it to move towards the module54. Since a measurement chamber202,684, formed between the membrane200,660and the module, is sealed with the membrane, the volume of air in the measurement chamber202,684is decreased with while the pressure in the chamber202,684is increased. The control module measures the pressure change inside the sealed measurement chamber and determines the pressure inside the OPEP chamber48(or14a,14b), or flow channel624, using a conversion algorithm. During inhalation, the pressure in the chamber48,14aand/or14band flow channel624, becomes negative, which imparts a downward or inward force on the membrane200,660. As the flexible membrane is pulled away from the control module54,608,908, the pressure inside the measurement chamber is decreased, or becomes negative. Again, the control module54,608,908measures this pressure chamber and determines the corresponding, or actual, pressure in the chamber48or flow channel625. As such, the module54,608,908measures pressure without being in fluid communication with the chamber48, or flow channel624, and the user's inspiratory/expiratory flow.

Referring toFIGS.77and78, the damping orifice784pre-damps the pulsations of the membrane660, which can smooth the pressure curve with less pulsations, thereby providing an easier analysis for the algorithm and a more precise output.

Referring toFIGS.44,83and84, the controller158, BTLE module, LED indicator, memory, pressure sensor are in electrical contact with the power source, e.g., battery. The controller receives a signal from the pressure sensor and sends/receives data to/from the BTLE module, which then communicate with the mobile device62, or other user interface and/or processor. The controller also sends a signal to the LED indicator154,750as required, and can save data to, and recall data from, the internal memory. The data can be further communicated to and stored on a memory card950, an SD card installed in the port, or be communicated via the micro USB port. A real time clock952and back-up battery954may also be incorporated into the PCB board940.

Referring toFIGS.6,7Aand B, a flex sensor100is shown as being disposed adjacent a high pressure cavity or zone defined by the chamber48. The resistance through the flex sensor is proportional to the amount of flex applied and may be used as an indirect measurement of pressure. The flex sensor may be positioned on the low pressure side of a silicone membrane102. The membrane102moves in response to a pressure increase inside the cavity or system, causing the sensor100, cantilevered over the membrane or an actuation pad extending therefrom, to flex. The membrane102may include an actuation pad104that engages the flex sensor100. The resistance change from the flexing may be correlated to the pressure in the system. The electronic components, including the sensor, are separated from the flow path by the membrane102, which prevents contamination. Cleanliness of the flow path may be particularly important to CF patients. At the same time, the electronic components may be easily removed for cleaning and disinfecting.

Referring toFIGS.8Aand B, a non-contact position sensor106may provide either an absolute or relative position of an object, and like the flex sensor, may be used to indirectly measures pressure changes. Some types of non-contact position sensors are capacitive displacement sensor, ultrasonic sensors, and proximity sensors. The sensors may be used to measure the displacement of a moveable surface that respond to pressure changes. At ambient, or atmospheric pressure, a base component108coupled to a silicone bellow112is positioned a distance “x” mm from a sensor110. As the pressure increases, the base108, attached for example with rolling bellows, is moved toward the sensor110, e.g., cap active displacement sensor, and the distance “x” decreases. Therefore, the distance between the base108and the sensor110is inversely proportional to the pressure. If the pressure increases, the distance decrease, and vice versa. The sensor may also measure negative pressure, for examples as the distance “x” increases.

If the pressure inside the device is too high, the silicone bellows may not be stiff enough to resist bottoming out. As shown inFIG.9, an assist spring112, such as a mechanical compression spring, may be disposed between the base108and sensor110. In this way, the system is able to measure increased pressures. As with the embodiment ofFIGS.7Aand B, the electronic components ofFIGS.8A, B and9are separated and isolated from the flow path by the silicone membrane or bellows. In addition, the electronic components may be removable.

Referring toFIG.10, a linear variable differential transformer (LVDT)112is shown. The LVDT is a contact sensor, and directly measures the linear displacement of the flexible membrane102or base108shown in the prior embodiments. The displacement may be correlated to pressure.

Referring toFIG.11, a conductive membrane114is provided. The membrane is made using silicone with conductive properties. As the pressure inside of the system increases, the membrane deflects and the resistance or capacitance changes, which may be correlated to the pressure.

Referring toFIG.12, a magnet116is configured with a spring. As the pressure inside the system changes, the distance between the magnet and Hall Effect sensor120may be correlated to pressure. A return spring118may be coupled to the magnet.

Referring toFIG.13, a light curtain122may be used to determine the displacement of a membrane124, which is displaced by pressure. As the pressure increases, a base or platform portion126of a membrane moves through the light curtain122, with the movement correlated to pressure.

Referring toFIGS.5E and14, a potentiometer vane88is disposed in the flow path70. The amount of rotation of the vane is proportional to the flow inside the chamber, and ultimately to pressure. A return spring92is incorporated to reset the vane when zero flow is present.

Referring toFIG.15, a Piezo flex sensor128is disposed in the flow path. The flex sensor bends in response to the air flow of the chamber. As the sensor bends, the resistance changes. The change of resistance may be correlated to flow rate, and pressure.

Referring toFIGS.16,17,47and48, a proximity sensor130is used to detect the presence of nearby objects without physical contact. In this case, a proximity sensor130is used to detect if the tip of a vane134is present. Every time the vane oscillates, the sensor would detect its position and the time between oscillations can be calculated. In the closed position, the vane comes within 5 mm of the sensor at the highest resistance setting. A lower resistance setting will decrease the distance between the vane and the sensor.

Another embodiment uses a proximity sensor136to monitor the control nozzle30. As the valve assembly and/or vane134opens and closes to create the pressure oscillations, the flow within the device also oscillates. When the flow is high the control nozzle30is in the open state, and when the flow is low the control nozzle is in the closed state. The open/closed motion of the control nozzle30may be detected and converted to frequency.

An accelerometer measures proper acceleration and can be used to calculate frequency from the vibrations as the valve assembly and/or vane134opens and closes. The accelerometer may be placed on the device in the location that provides the greatest vibration.

A microphone140, similar to the one shown inFIG.18, may be mounted on a PCB and placed in the same location as the proximity sensor inFIGS.16and/or17. The microphone would pick up the sound of the airflow starting and stopping, plus any mechanical contact that occurs with the oscillating mechanism.

As shown inFIG.19, an LED142and Photo sensor144may be used to calculate the frequency of the oscillating mechanism. In this arrangement, the LED is located on one side of the butterfly valve146and the photo sensor144is on the other. As the valve opens, light passes through the valve seat and is measured by the photo sensor. As the valve closes, or engages the seat148, light is blocked from reaching the photo sensor144. The timing of this data can be used to calculate the frequency.

Another LED/Photo sensor arrangement is shown inFIG.20. In this arrangement, the LED is located at the far side of the vane chamber14b, and the photo sensor is located on the side wall by one of the exhaust ports18. As the vane134pivots to one side, it blocks light from reaching the photo sensor. As the vane pivots to the other side, light from the LED is able to reach the photo sensor. The timing of this data may be used to calculate the frequency.

Referring toFIG.21, a mobile device62, such as a smartphone, may include an app providing an INPUT if the Smart features are not integrated into the OPEP device. The app may allow selection of the desired feedback and adjustment of targets and/or limits.

Input on the user's quality of life is used to calculate a QoL score which may be correlated with DFP performance. Various inputs may be used to calculate a QoL score and algorithms could be tailored or adjusted for different disease types. User input may be performed with an auxiliary input component, such as computer device, for example a smartphone app. Some examples of QoL inputs are:St. George's Respiratory questionnaire for COPDSimplified questionnaireUser's journalSteps/dayNumber of hours the user is sedentary

Various features and/or inputs for a device “wake up” include but are not limited to one or more of an accelerometer, pressure sensor, flow sensor, humidity sensor, temperature sensor, mechanical switch/button, pressure switch, flow switch, temperature switch, infrared light sensor, conductive switch/lips on mouthpiece or hand on device/closing circuit, humidity sensor, flex sensor on membrane, capacitive displacement, linear variable differential transformer, conductive membrane, microphone, MAF sensor, hot wire, programmable timer/user/alarm reminder. Various features and/or inputs for a session identification (ID), session “start” and “stop” times and “duration” include a software clock and/or algorithm. Various features and/or inputs for the “breath count” include but are not limited to an accelerometer, pressure sensor, flow sensor, humidity sensor, temperature sensor, microphone and/or mechanical switch. Inputs and features for the average pressure and average frequency include but are not limited to one or more of the various sensors discloses herein throughout. An “instant pressure alert” may include an algorithm that alerts the user in real time when a predetermined (preset) maximum pressure threshold is exceeded. The alert may be visual (LED, screen display), haptic or audible. On or more of a mucus number (lung obstruction level), cough number, and/or wheezing number may be calculated by algorithms from humidity, temperature, and microphone sensor data, including for example providing ratings for each on a 1 to 10 scale. A breath temperature may be calculated by a temperature sensor, while breath humidity may be calculated by a humidity sensor. A device alarm timer may be a programmable feature that alerts/reminds the user to use the device. The snooze button may be actuated to reset/snooze the alarm for a predetermined time period (e.g., 10 minutes) up to a maximum number of resets (e.g., 6), with the reminder then being turned off automatically. A session pause/play feature provides the user with the flexibility to pause the treatment session, for example if something important interrupts the session, and then restart the session once it is more convenient. An algorithm calculates actual use time, eliminating the pause time. A cleaning reminder may be visual (blinking LED lights), audible, or haptic. The timed reminder, based for example on the actual time used, number of uses, number of breaths and/or total time, or some combination thereof, provide indicia or a reminder to clean the device as recommended. The reminder may be programmed to provide an alert to fit a particular schedule. A device replacement warning provides the user and/or other recipient with indicia or a prompt that the device needs to be replaced. The reminder may be visual (blinking LED lights), audible, or haptic. The a warning may be based for example on the actual time used, number of uses, number of breaths and/or total time, or some combination thereof. The warning may be programmed to provide an alert to fit a particular schedule. A therapy completion notification may be based on an algorithm that calculates the time of a session based on the amount of breathes, and the session quality (e.g., average pressure within a recommended range (e.g., 10 to 20 cm/H2O)). The data may be transmitted to connected devices (whether hardwired or wireless), including USB, Bluetooth, WiFi and other known communication systems.

Outputs

Referring toFIGS.22and23, an output is defined as new information that is leaving the Smart OPEP ‘system’, with the information being communicated by an output component. The output may take the form of visual, audible, and sensory feedback, or be related to the user's quality of life and disease progress. A number of outputs and output components are suitable, including a visual output component, which may be easily integrated into the Smart OPEP device and allow several levels of feedback. For example, an array150of three (3) LEDs152, each with a different color may indicate if the input is low, high, or acceptable. Instead of three (3) separate LEDs (e.g., red, amber and green), a single tri-color LED154may also be used. If more than three (3) discreet states of feedback are required, then a LED bar graph156may be used.

Referring toFIGS.51,55,74A and74B, the user interface may also include a display screen420(e.g., LED display screen), which may display various data and information, both in real time and on a command/retrieval base. The user interface/control module408may also include a micro USB port422which provides for the transfer of data and/or charging of the module. The module408may also include a micro SD card port424, in which an SD card may be inserted to exchange (upload/download) data. The module may also include a microphone and/or speaker426, which may provide the audible output, but also provide for audible input and commands that may be recognized and followed operated/acted on by the control module408. The user interface may include a touch screen for inputting data and instructions to the control module.

Audible and sensory/tactile (vibration) outputs and output components may also be used to provide feedback to the user. For example, sound or vibration occurs while the input is within the acceptable range, or if the input exceeds a specified limit.

A mobile device62, or other computer interface, may function as the output component and provide an interface with a smartphone app as an output if the Smart features are not integrated into the OPEP device. The app could display real-time performance characteristics, data trends, or games that motivate the user to complete a session.

Referring toFIGS.62-76B and83-87, the operation of the smart OPEP provides a smart data logger. It should be understood that the user interface and control module may be used with other types of respiratory care systems. The user interface provides the patient/user, caregiver (e.g., doctor), insurers, and other health care providers with various useful information that may be used to further improve the health of the patient/user. The interface may provide the various recipients with information and guidance on when to use the device, alerts if a pre-set (input) pressure threshold is exceeded, provide information about when the device should be cleaned (e.g., regular intervals) with minimal input from the user, and inform the user and/or other intended recipients when the therapy session is completed. In one embodiment, the user may pick up the device, use the device with minimal interaction/effort (e.g., no manual logging or interfacing with an electronic input device), and put the device back down until the next use. The module may record all of the information gathered by the various sensors and other inputs and live display it to the user, for example through the display420, or log/store the data for later review, for example by downloading it to an SD card inserted into the port424, or to a computer or other device by way of the USB port422. The device may also transmit the data wirelessly to a device, such as a PC, table, smart phone (e.g., mobile app), and other know and suitable devices. As mentioned, the module may have a live display420, or a connection (hardwire or wireless) to a smart device with a digital display, where either the module (via display420or microphone426) or digital display would be able to alert the user, or other intended recipient, when it is time to perform a treatment session, inform the user when it is time to clean the device, inform the user when it is time to replace the device, and/or inform the user when the treatment session has been completed. The device may also inform the user, or intended recipient, about session duration, number of breathes taken, average treatment pressure, average treatment frequency, maximum pressure warning, low battery warning, mucus obstruction level, cough intensity level, wheezing intensity level, breath temperature and breath humidity level. The device communication with the user may be visual, auditory or haptic. The user may also actuate a push button, or actuator430, to delay or reset a reminder alarm (e.g., snooze) if not convenient at the moment. The actuator may also be actuated to power up (wake up) or turn on the module.

In the embodiment ofFIGS.79-87, the accelerometer930senses movement and wakes the device up, for example movement in the 0 to 1G range. Conversely, if the device is left undisturbed, the device will time out and go to sleep automatically.

In operation, and referring toFIGS.63-76B and85-85B, the module may provide a session reminder, e.g., auditory or visual alarm. The time and frequency of the reminders may be programmable by the user and/or other provider, locally or remotely. Once the alarm is activated, the user may reset the alarm with a delay (i.e., snooze), e.g., 10-30 minutes by actuating the actuator430, or turn the time off altogether, for example by holding the button down or entering a sequence of button pushes. If the snooze is not activated, the module will then determine whether an input was received from one or more sensors, including a pressure, flow, humidity, temperature, flex sensor or membrane, capacitive displacement, linear variable differential transformer conductive membrane and/or light curtain. For example, input about whether the user is blowing into the device is detected. If an input, movement and/or action was detected, the device powers up, with the LED activated and the time/date of the session being logged. If no input or action is detected, the device will again enter sleep mode.

Once the device is powered up, for example by turning on the switch430, or by way of movement being detected by the accelerometer930, with the LED indicating as much (seeFIGS.67and85Aand B), an algorithm calculates and records the average pressure of the session using input from one more sensors, including for example and without limitation a pressure, flex sensor on membrane, capacitive displacement, linear variable differential transformer, conductive membrane and/or light curtain, or combinations thereof. The frequency of the sessions (e.g., average thereof) may also be recorded based on input from one or more sensors, including a pressure, accelerometer, flex sensor on membrane, microphone, capacitive displacement, linear variable differential transformer, conductive membrane and/or light curtain, or combinations thereof. The number of breaths during each session may also be recorded based on input from one or more sensors, including a pressure, flow, humidity, temperature, flex sensor on membrane, microphone, capacitive displacement, linear variable differential transformer, conductive membrane and/or light curtain, or combinations thereof. As the user continues to interface with the device, e.g., blow into the device, the sensors and module continue to record and calculate the data. Once the sensors and module determine the user is no longer using the device, e.g., blowing into the device, the device may time out after a predetermined time period (e.g., 10 sec. to 5 minutes), or the switch may be turned off, with the LED providing an indicator that the device is no longer being powered. The data may be stored in an SD card, and/or transmitted to a mobile app, personal computer, whether hardwired or wirelessly.

During use, the visual display may display, or provide indicia about, the session date, start time, session duration timer, a session pause/play interface (e.g., touchscreen actuator), breath counter (number of exhalations), average exhalation duration, average pressure, average frequency, instant pressure alert (e.g., maximum exceeded) mucus number/rating, cough number/rating, wheezing number/rating, breath temperature, breath humidity, average exhalation time (%) where the pressure>5 cmH2O, device cleaning reminder or device life status. The same data/information may be stored, along with the session identification and start time. The LED display may turn off after the session is terminated and the device enters sleep mode.

Referring toFIG.65, the actuator may be actuated, e.g., button pushed, to wake the device up, or an accelerometer may wake the device, which activates a visual display, e.g., LED light. As the user blows into the device, e.g. mouthpiece, the algorithm again calculates the number of breaths per session, the average pressure during the session and the instant pressure (e.g. maximum) (manometer) using a pressure sensor434or microthermal flow sensor436. The LED array may provide a real time visual display, or feedback, to the user about the instant pressure, for example red (too high or exceeding maximum limit), amber (reaching/approaching maximum limit) or green (in predetermined acceptable range).

The pressure sensor434,730or microthermal flow sensor436may be separated by a flexible membrane440,660from the OPEP flow channel, with the membrane defining a sealed off chamber438,684as shown inFIGS.60-76B. The indirect pulsating pressure created by the membrane440,660in the chamber438,684in response to the pulsating pressure in the OPEP is detected by the pressure sensor434,730. Likewise, the indirect pulsating air flow created by the membrane440response to the pulsating pressure in the OPEP is detected by the microthermal flow sensor. For example, the pulsating pressure in the OPEP may be 0 to 60 cm H2O.

Feature: Performance Targets

This feature provides feedback to the user based on specific performance targets. For example, if the mean pressure is to be within 10 to 15 cmH2O, this feature would notify the user that their mean pressure is too high, too low, or acceptable. The performance targets can be set by the patient or health care provider, or default to limits based on generally accepted treatment protocols.

The general layout for this feature is shown below inFIG.24and includes a sensor154, which may include without limitation any one of the sensors previously disclosed herein, or combinations thereof, the ability to process raw data, including for example a processor158, an output component150,154,156to display feedback, and if necessary, the ability to enter performance limits manually. The location of the sensor may change depending on the type of sensor selected or the performance characteristic being measured as disclosed herein with respect to various embodiments.

The performance characteristics that could be included in this feature are referred to above and herein. The following table lists exemplary performance characteristics and various suitable sensors for measuring the characteristics.

TABLE 1Performance CharacteristicsTrueUpperLowerPerformanceFre-MeanMeanAm-Pres-Pres-CharacteristicquencyPressurePressureplitudesuresurePressureXXXXXXSensorFlex SensorXXXXXXNon-contactXXXXXXPositionSensorLVDTXXXXXXConductiveXXXXXXMembraneHall EffectXXXXXXSensorLight CurtainXXXXXXFlow SensorXPotentiometerXVanePiezo FlexXSensorLED/PhotoXSensorProximityXSensorAccelerometerXMicrophoneX

The flow chart for this feature is shown inFIG.25. The dashed area represents an integrated embodiment that does not allow the target limits to be adjusted and in this case provides feedback on the mean pressure.

In operation, the user first selects the type of feedback. The “Get Type & Set Type” define the performance characteristic to be analyzed. Next, the user decides if custom targets are to be used and enters the limits. If not, default limits are set based on the performance characteristic selected. Next, the sensor154begins sending raw data and the selected performance characteristic is calculated. Next, a series of decisions are made based on the calculated value of the performance characteristic. If the value is greater than the upper limit, then the output is high. If the value is less than the lower limit, then the output is low. If the value is neither, than the output is OK. Next, the flow chart checks if the user has selected to end the feedback. If not, then the cycle repeats. The above logic provides 3 discreet states of feedback. If required, additional logic could be added to provide a finer resolution to the feedback.

The analysis may either be completed using a processor158, e.g., a microcontroller, embedded in the PCB, or may be performed using an external computing device, such as mobile device, including a smartphone or tablet. As seen in Table 1, frequency may be determined from any sensor, however, pressure outputs require a pressure sensor (either direct or indirect). In order to calculate frequency from a pressure input, processing techniques such as: Peak-to-Peak time, Fourier analysis, or Auto-correlation may be used.FIG.1illustrates an example of a pressure waveform that has been processed using a Peak-to-Peak technique.

If the input is a sound signal it can be averaged to simplify the waveform. The simpler waveform may then be processed in the same way as a pressure signal to determine frequency. Referring toFIG.26, the raw sound data (bars) has been averaged using the Root Sum of Squares technique and the result is shown by the line. Each peak (dot) is then identified and the time between peaks is calculated and used to determine the frequency.

The output for this feature can be visual160, audible162, or sensory164, and can be integrated into the device. An example of an integrated solution is shown inFIGS.4, and27-29. In one embodiment, an integrated solution would not provide for the selection of the performance characteristics or adjustment of the performance limits. In other embodiments, the integrated solution may provide a user interface permitting such selection and adjustment, for example through a keypad, buttons or touchscreen.

Referring toFIG.31, the algorithm for calculating the performance characteristics including recording the raw data, filtering or smoothing the raw data to remove any noise, which may be accomplished by known techniques including a moving average, Butterworth filter, Fourier filter or Kernel filter. The direction of the slope is determined using the filtered/smoothed data, whether positive or negative, with increasing=+1 and decreasing=−1. Slope changes between positive and negative are identified and labelled as a peak, with changes from negative to positive labeled as a trough. For each peak and trough, the timestamp and pressure value is logged. Exemplary data is shown inFIGS.46Aand B. Using the time and pressure value for each peak and trough, the frequency, amplitude and mean pressures are calculated.

A frequency analysis may be performed using the time and pressure data shown inFIGS.46Aand B. The waveforms produced by the patterns, shown for example inFIG.46A, were analyzed by applying a moving average to remove noise and determine the peaks. The time (t) between peaks is calculated, which outputs the frequencies (f), with f=fsample/t, where fsample=1000 Hz.

The computing device, such as a mobile device including a smartphone62, may function as the output device (and also the manual input (auxiliary input component) and analysis source). In these examples, the Smart OPEP communicates with the smartphone via a wireless protocol such as Bluetooth as shown inFIG.30. An application (app) will allow the user to input the desired performance characteristic and set the limits if necessary (FIG.21). An output screen170will display the target limits and provide feedback to the user (e.g., too high, too low, or ok) as shown inFIGS.21,23and32.

Referring toFIGS.33and34, another possible output for this feature may be to turn the session into a game. For example, and referring toFIG.33, the bird180represents the current performance characteristic value, which must pass through the pipes182without going outside the limits (upper and lower)184,186. If both frequency and pressure targets are required, care must be taken to ensure that the user is not overwhelmed with the feedback and is able to compensate their breathing technique to meet the required targets. A custom output graphic could be developed to aid the user in controlling two performance characteristics, such as frequency and pressure.FIG.34illustrates an example of a simple game that helps aid the user in controlling both frequency and pressure. The goal of the game is to get the ball into the hole and the current location of the ball is dependent on the frequency and pressure.

Referring toFIGS.45,86and87, to start a therapy session, the user first wakes the OPEP device, for example by pushing a manual button or automatically as the device is picked up by using the accelerometer930. Once awake, the device pairs with a mobile device, such as a smart phone, if available. If a mobile device is available, an application may be opened and any previous data saved in memory may be downloaded in the mobile device. The user may be prompted to modify performance targets if desired. Once performance targets are set, the application opens the feedback screen so that the user may monitor their performance throughout the treatment. If a smart phone is not available, the previous performance targets are used, and the data is saved internally. The OPEP device begins monitoring for positive pressure. If at any point during treatment, the device does not detect a positive pressure change for a specified amount of time, the device saves any treatment data to either the mobile device or the internal memory and enters a standby mode to conserve power. If positive pressure is detected, the OPEP device will begin to measure the pressure (positive and negative), calculate the performance characteristics such as frequency, amplitude and mean pressures and provide feedback to the user regarding their technique.

One aspect of the embodiments disclosed herein relates to the handling of data. Data logged by the OPEP may be transferred to an external device, such as a smartphone, tablet, personal computer, etc. If such an external device is unavailable, the data may be stored internally in the OPEP in a data storage module or other memory and transferred upon the next syncing between the OPEP and external device. Software may accompany the OPEP to implement the data transfer and analysis.

In order to provide faster and more accurate processing of the data, for example from one or more various sensors, generated within the smart OPEP, data may be wirelessly communicated to a smart phone, local computing device and/or remote computing device to interpret and act on the raw sensor data.

In one implementation, the smart OPEP includes circuitry for transmitting raw sensor data in real-time to a local device, such as a smart phone. The smart phone may display graphics or instructions to the user and implement processing software to interpret and act on the raw data. The smart phone may include software that filters and processes the raw sensor data and outputs the relevant status information contained in the raw sensor data to a display on the smart phone. The smart phone or other local computing device may alternatively use its local resources to contact a remote database or server to retrieve processing instructions or to forward the raw sensor data for remote processing and interpretation, and to receive the processed and interpreted sensor data back from the remote server for display to the user or a caregiver that is with the user of the smart OPEP.

In addition to simply presenting data, statistics or instructions on a display of the smart phone or other local computer in proximity of the smart OPEP, proactive operations relating to the smart OPEP may be actively managed and controlled. For example, if the smart phone or other local computer in proximity to the smart OPEP determines that the sensor data indicates the end of treatment has been reached, or that further treatment is needed, the smart phone or other local computing device may communicate such information directly to the patient. Other variations are also contemplated, for example where a remote server in communication with the smart phone, or in direct communication with the smart OPEP via a communication network, can supply the information and instructions to the patient/user.

In yet other implementations, real-time data gathered in the smart OPEP and relayed via to the smart phone to the remote server may trigger the remote server to track down and notify a physician or supervising caregiver regarding a problem with the particular treatment session or a pattern that has developed over time based on past treatment sessions for the particular user. Based on data from the one or more sensors in the smart OPEP, the remote server may generate alerts to send via text, email or other electronic communication medium to the user, the user's physician or other caregiver.

The electronic circuitry in the smart OPEP (e.g. the controller arrangement ofFIGS.4,44,83and84), the local computing device and/or the remote server discussed above, may include some or all of the capabilities of a computer in communication with a network and/or directly with other computers. As illustrated inFIGS.49and50, the computer500may include a processor502, a storage device516, a display or other output device510, an input device512, and a network interface device520, all connected via a bus508. A battery503is coupled to and powers the computer. The computer may communicate with the network. The processor502represents a central processing unit of any type of architecture, such as a CISC (Complex Instruction Set Computing), RISC (Reduced Instruction Set Computing), VLIW (Very Long Instruction Word), or a hybrid architecture, although any appropriate processor may be used. The processor502executes instructions and includes that portion of the computer500that controls the operation of the entire computer. Although not depicted inFIGS.49and50, the processor502typically includes a control unit that organizes data and program storage in memory and transfers data and other information between the various parts of the computer500. The processor502receives input data from the input device512and the network526reads and stores instructions (for example processor executable code)524and data in the main memory504, such as random access memory (RAM), static memory506, such as read only memory (ROM), and the storage device516. The processor502may present data to a user via the output device510.

Although the computer500is shown to contain only a single processor502and a single bus508, the disclosed embodiment applies equally to computers that may have multiple processors and to computers that may have multiple busses with some or all performing different functions in different ways.

The storage device516represents one or more mechanisms for storing data. For example, the storage device516may include a computer readable medium522such 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, any appropriate type of storage device may be used. Although only one storage device516is shown, multiple storage devices and multiple types of storage devices may be present. Further, although the computer500is drawn to contain the storage device516, it may be distributed across other computers, for example on a server.

The storage device516may include a controller (not shown) and a computer readable medium522having instructions524capable of being executed on the processor502to carry out the functions described above with reference to processing sensor data, displaying the sensor data or instructions based on the sensor data, controlling aspects of the smart OPEP to alter its operation, or contacting third parties or other remotely located resources to provide update information to, or retrieve data from those remotely located resources. In another embodiment, some or all of the functions are carried out via hardware in lieu of a processor-based 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 electronic mail system, a media manager, an image manager, or may include any other functions capable of accessing data items. The storage device516may also contain additional software and data (not shown), which is not necessary to understand the invention.

The output device510is that part of the computer500that displays output to the user. The output device510may be a liquid crystal display (LCD) well-known in the art of computer hardware. In other embodiments, the output device510may be replaced with a gas or plasma-based flat-panel display or a traditional cathode-ray tube (CRT) display. In still other embodiments, any appropriate display device may be used. Although only one output device510is shown, in other embodiments any number of output devices of different types, or of the same type, may be present. In one embodiment, the output device510displays a user interface. The input device512may be a keyboard, mouse or other pointing device, trackball, touchpad, touch screen, keypad, microphone, voice recognition device, or any other appropriate mechanism for the user to input data to the computer500and manipulate the user interface previously discussed. Although only one input device512is shown, in another embodiment any number and type of input devices may be present.

The network interface device520provides connectivity from the computer500to the network526through any suitable communications protocol. The network interface device520sends and receives data items from the network526via a wireless or wired transceiver514. The transceiver514may be a cellular frequency, radio frequency (RF), infrared (IR) or any of a number of known wireless or wired transmission systems capable of communicating with a network526or other smart devices102having some or all of the features of the example computer ofFIGS.49and50. The bus508may represent one or more busses, e.g., USB, PCI, ISA (Industry Standard Architecture), X-Bus, EISA (Extended Industry Standard Architecture), or any other appropriate bus and/or bridge (also called a bus controller).

The computer500may be implemented using any suitable hardware and/or software, such as a personal computer or other electronic computing device. The computer500may be a portable computer, laptop, tablet or notebook computers, smart phones, PDAs, pocket computers, appliances, telephones, and mainframe computers are examples of other possible configurations of the computer500. The network526may be any suitable network and may support any appropriate protocol suitable for communication to the computer500. In an embodiment, the network526may support wireless communications. In another embodiment, the network526may support hard-wired communications, such as a telephone line or cable. In another embodiment, the network526may support the Ethernet IEEE (Institute of Electrical and Electronics Engineers) 802.3x specification. In another embodiment, the network526may be the Internet and may support IP (Internet Protocol). In another embodiment, the network526may be a LAN or a WAN. In another embodiment, the network526may be a hotspot service provider network. In another embodiment, the network526may be an intranet. In another embodiment, the network526may be a GPRS (General Packet Radio Service) network. In another embodiment, the network526may be any appropriate cellular data network or cell-based radio network technology. In another embodiment, the network526may be an IEEE 802.11 wireless network. In still another embodiment, the network526may be any suitable network or combination of networks. Although one network526is shown, in other embodiments any number of networks (of the same or different types) may be present.

It should be understood that the various techniques described herein may be implemented in connection with hardware or software or, where appropriate, with a combination of both. Thus, the methods and apparatus of the presently disclosed subject matter, or certain aspects or portions thereof, may take the form of program code (i.e., instructions) embodied in tangible media, such as floppy diskettes, CD-ROMs, hard drives, or any other machine-readable storage medium wherein, when the program code is loaded into and executed by a machine, such as a computer, the machine becomes an apparatus for practicing the presently disclosed subject matter. In the case of program code execution on programmable computers, 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 may implement or use the processes described in connection with the presently disclosed subject matter, e.g., through the use of an API, reusable controls, or the like. Such programs may be implemented in a high level procedural or object-oriented programming language to communicate with a computer system. However, the program(s) can be implemented in assembly or machine language, if desired. In any case, the language may be a compiled or interpreted language and it may be combined with hardware implementations. Although exemplary embodiments may refer to using aspects of the presently disclosed subject matter in the context of one or more stand-alone computer systems, the subject matter is not so limited, but rather may be implemented in connection with any computing environment, such as a network or distributed computing environment. Still further, aspects of the presently disclosed subject matter may be implemented in or across a plurality of processing chips or devices, and storage may similarly be spread across a plurality of devices. Such devices might include personal computers, network servers, and handheld devices, for example.

Providing feedback to users regarding their technique is one feature of the smart OPEP that will help optimize treatment. A controller158, which may be located on or inside the various embodiments of the smart OPEP described herein, is in communication with one or more sensors, switches and or gauges that are tracking or controlling operation of the smart OPEP. The controller may store data gathered in a memory for later download to a receiving device, or may transmit data to a receiving device in real-time. Additionally, the controller may perform some processing of the gathered data from the sensors, or it may store and transmit raw data. RF transmitter and/or receiver modules may be associated with the controller on the smart OPEP to communicate with remote hand-held or fixed computing devices in real-time or at a later time when the smart OPEP is in communication range of a communication network to the remote hand-held or fixed location computing devices. The controller may include one or more of the features of the computer system500shown inFIG.49. Additionally, the one or more sensors, switches or gauges may be in wired or wireless communication with the controller.

For clarity in displaying other features of the various Smart OPEP embodiments described, the controller circuitry is omitted from some illustrations, however a controller or other processing agent capable of at least managing the routing or storing of data from the smart OPEP is contemplated in one version of these embodiments. In other implementations, the smart OPEP may not include an onboard processor and the various sensors, gauges and switches of a particular embodiment may wirelessly communicate directly with a remotely located controller or other processing device, such as a handheld device or remote server. One embodiment of a circuit is shown inFIGS.83-85B. Data gathered by a controller or other processing device may be compared to expected or pre-programmed values in the local controller memory or other remote location to provide the basis for feedback on whether desired performance or therapy is taking place. If the controller is a more sophisticated and includes more of the computer500elements described inFIG.49, then this processing may all be local to the smart OPEP. In more rudimentary controller arrangements, the data may simply be date/time stamped and stored locally or remotely for later processing. In one embodiment, the data may further be locally or remotely stamped with a unique device or patient identifier.

Feature: Performance Limits

Referring toFIG.35, the patient or HCP may be notified if a pressure characteristic is exceeded. The main purpose for this feature is to ensure patient safety and is a simplified version of the previous feature. For example, OPEP therapy is used post-operatively and patients may need to remain below a certain pressure. The flow chart inFIG.35is similar to the flow chart ofFIG.25, but only contains an upper limit. Any of the outputs discussed above may be used in this feature, such as visual, audible, vibration, or a smartphone display.

Feature: Real-Time DFP Feedback

Previous features may only inform the user if the input is high, low, or acceptable. An additional feature provides quantitative real-time feedback of the desired performance characteristic.

All of the inputs listed in the previous features can be used for this feature:10.2.1. Pressure Sensor10.2.2. Flex Sensor10.2.3. Non-contact Position Sensor10.2.4. LVDT10.2.5. Conductive Membrane10.2.6. Hall Effect Sensor10.2.7. Light Curtain10.2.8. Flow Sensor10.2.9. Potentiometer Vane10.2.10. Piezo Flex Sensor10.2.11. LED/Photo Sensor10.2.12. Proximity Sensor10.2.13. Accelerometer10.2.14. Microphone

The inputs can be analyzed to determine:10.3.1. Peak and valley detection10.3.2. Average peak10.3.3. Average valley10.3.4. Amplitude10.3.5. Mean pressure10.3.6. True mean pressure10.3.7. Frequency

In order to display the DFP in real-time, a computer device, such as a laptop, smartphone, or tablet, or other separate device with a display is required.

Feature: DFP History

Another feature provides a way for the patient or HCP to review DFP data from previous sessions. DFP data can be displayed over time and the user can retrieve and display the data by some temporal component, including for example and without limitation day, week, month, year, or all time. This allows the user to quickly visualize trends in the performance.

Feature: Ensure Proper Setting

This feature provides feedback to the user regarding the appropriate resistance setting. In one embodiment, the OPEP device provides five (5) resistance settings which change the frequency, amplitude and mean pressure performance. For a given flow rate, increasing the resistance setting increases the frequency and pressure characteristics. In one embodiment, for example the Aerobika® OPEP device IFU, the correct resistance setting will produce an I:E ratio of 1:3 or 1:4 for 10-20 min without excess fatigue. Therefore, the input will be used to identify the start and end of the inspiratory and expiratory cycles. Some possible inputs include a flow sensor, pressure sensor, or microphone.

A flow sensor may be placed in the mouthpiece and used to determine the I:E ratio. A single flow sensor, placed at location 1 inFIG.36, would need to be able to measure flow in both directions. It would also be possible to use two (2) one-way flow sensors: one in the location 1 for exhalation and one in location 2, as shown inFIG.36, for inhalation.

A pressure sensor may be used to calculate the I:E ratio. If the pressure is negative then the flow is inspiratory, and if the pressure is positive then the flow is expiratory. The pressure sensor may be positioned as shown inFIG.24.

In an alternative embodiment, two (2) microphones may to be used for the calculation of the I:E ratio, similar to the dual flow sensors shown inFIG.36. A single microphone would only be able to identify if flow is occurring, and not if it is inspiratory or expiratory.

To analyze the I:E ratio, four (4) time points need to be determined: the start and end of inhalation (T1 and T2), and the start and end of exhalation (T3 and T4). The analysis could follow the logic shown inFIG.37. If two (2) sensors are used, additional logic is required to determine if the flow is inspiratory or expiratory.

If Sensor 1 is ON and Sensor 2 is OFFThen flow is expiratoryIf Sensor 1 is ON and Sensor 2 is ONThen flow is inspiratory

The output of this feature would make recommendations to the user to either increase resistance, decrease resistance, or leave the resistance setting unchanged. An output component may be embedded in the device and be either visual, audible, or tactile as shown inFIGS.27-28, or, the output may be shown on a separate device such as a smartphone, or other computer device or screen.

Feature: Setting Recommendation Based on Previous Data

This feature will analyze previous DFP data and make setting recommendations. This feature may calculate the I:E Ratio for each breath and then calculate the average I:E Ratio for a session. Based on the average I:E Ratio, this feature would make a setting change recommendation using the logic shown inFIG.37and/or referred to above.

Feature: Proper Technique

This feature will provide the user with training and coaching on proper technique for performing an OPEP maneuver based on the IFU, and may be updated for other devices. In one embodiment, this feature may take the form of an app, and will communicate with the OPEP device via BTLE (seeFIG.4for more details).

A proper OPEP maneuver relies on several variables, such as I:E Ratio, frequency, pressure, and setting. These inputs have been previously discussed.

The ideal OPEP maneuver follows these steps: Inhale slowly, taking a deeper breath than normal but not filling the lungs, hold your breath and exhale 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 could be re-evaluated if the user's performance changes. To start, the user would inhale normally through the device in order to calculate their baseline inspiratory pressure, or IPTidal, or Tidal Volume (TV). Next, the user would inhale fully through the device to calculate their maximum inspiratory pressure, or IPmax, or Inspiratory Capacity (IC). The app would then calculate the target inspiratory pressure (IPtarget) or volume for step #1 which is more than IPtidal(or the Tidal Volume) and less than the IPmax(or Inspiratory Capacity). A starting point for the IPtarget(or target inspiratory volume) would be the average of IPtidaland IPmax(or the TV and the IC).

The next step involves holding your breath for 2-3 seconds. Breath hold=T3−T2.

Next, the user exhales actively, but not forcefully. Frequency and pressures should be within target range and exhalation should last 3-4 times longer than inhalation. Exhaling actively is a subjective description of the OPEP maneuver, therefore, the app will calculate the frequency, mean pressure and I:E ratio in real-time, and use that information and data to determine if the proper technique is being achieved.

The output of this coaching feature will guide the user toward the correct OPEP technique based on the user's breathing pattern and specific performance targets. If any of steps above are not performed correctly, the app will make suggestions to change the user's technique. For example, if the user doesn't hold their breath before exhaling, the app would offer a reminder. In another example, the app may suggest that the user increase their flow rate because the mean pressure is too low and is not within the accepted limits. To declare the user “trained”, the app may require the user to demonstrate a proper OPEP maneuver several times. The app could also play audio of a proper OPEP maneuver, which may assist the user in exhaling actively. The app may also include training videos explaining the proper technique and examples of people performing proper OPEP maneuvers. The app may also notify the user's healthcare provider (HCP) if proper technique isn't being completed.

Feature: Session Assist

In addition to the coaching feature, the Smart OPEP device can assist the user in following the correct therapy regime. Session Assist features aid the user or HCP in completing an OPEP session. For the first time user, an OPEP session can be confusing and complicated. The user needs to count the number of breaths, remember proper technique, remember when to perform ‘Huff’ coughs, and etc. For example, the Aerobika® OPEP device IFU recommends the following steps: perform 10-20 OPEP maneuvers or breaths, after at least 10 breaths, perform 2-3 ‘Huff’ coughs, repeat for 10-20 minutes twice/day on a regular base, increase to 3-4 times/day if needed.

Using the inputs defined earlier, this feature would count the number of breaths and provide feedback to the user, either with the number remaining or the number completed. The app would then remind the user to perform ‘Huff’ coughs after the appropriate number of breaths, and then repeat the breath counting/huff cough cycle for 10-20 minutes. The user may input the total number of breaths to complete or total session time as a goal and track progress. The Session Assist feature would also track the number of sessions per day, which can be used to determine the user's progress or quality of life.

Feature: Quality of Life Score

This feature transforms quantitative data into qualitative data that is easier for the user, HCP, or payer to understand. There are three (3) steps involved: determine the user's Quality of Life (QoL) score, correlate past DFP performance to QoL score, and predict QoL score based on DFP performance trends. Various inputs may be used to calculate a QoL score which will be correlated with DFP performance. Inputs may be both qualitative and quantitative. Algorithms may be tailored or adjusted for different disease types. Some examples of QoL inputs are: St. George's Respiratory questionnaire for COPD, simplified questionnaire, user's journal, steps/day, and/or number of hours the user is sedentary.

The objective is to calculate a QoL score that evolves over time as the user's condition improves or worsens. Initially, the user completes a questionnaire and a baseline QOL score is computed. The user's journal would be scanned for keywords such as: good day, bad day, cough, out of breath, etc., and the QoL score would be adjusted based on the number of times keywords appear (i.e. good day=+1, out of breath=−1). The application may also calculate (or integrate with another app or device such as a FitBit) the number of steps taken per day and use this information to adjust the QoL score.

Once a QoL score has been generated, the app would determine a relationship between the QoL score and the measurements in the DFP history. This would require a period of time when the app is ‘learning’ how the two (2) variables relate. In the following example, after one week of OPEP sessions (2×/day) and daily QoL input from the user, the following linear regression equation is defined: QoL=5.6×MP−6.8 as shown inFIG.39. A linear regression equation may also be calculated for each of the other measurable and the equations with the highest “m” magnitude (y=mx+b) would be used to predict the QoL score. For example, if the Frequency/Qol equation was: QoL=1.2F+5.2 it would indicate that, for this particular user, changes in frequency would be less likely to indicate a change in QoL than changes in Mean Pressure. A flow chart for this feature is shown inFIG.40. Outputs for this feature include: current and previous QOL score, suggestions improve QOL score, measureable vs. QOL score and linear regression results, encouragement when QoL score decrease, and/or notification to HCP when QoL score decreases.

Feature: Device Status

This feature provides feedback to the user about the device itself. Several options exist, including notifying the user, HCP or payer that the device needs to be replaced. This may take the form of a reminder in the app, or could lockout features until a new lot number or serial number is entered. The feedback may also include notifying the user when the device needs to be cleaned. Cleaning notifications could be based on the number of sessions between cleaning and/or changes in device performance over time.

Feature: Stakeholder Updates

A stakeholder is defined as an individual or organization, outside the patient's immediate family, that has an interest in the patient's condition, treatment, and progress. Stakeholders may be the patient's doctor, respiratory therapists, hospital, or insurance company. Some examples of stakeholder updates include: updating an insurance company with the user's usage data to monitor patient adherence and/or updating HCP with user's progress since last visit, usage data, and QoL score.

Feature: Active OPEP

Referring toFIG.41, a device is disclosed that automatically adjusts the resistance to keep the selected performance characteristic (e.g., pressure (amplitude) and/or frequency) in the desired range. The range and/or performance characteristic to be controlled may be pre-programmed into the device or be inputted by the user as described above. The microprocessor would receive data from the sensor and an algorithm would decide how to adjust the device. The microprocessor would then give a command to a motor190and the motor would physically perform the adjustment of a control component, such as the valve seat148or orientation of the chamber inlet. The encoder192would confirm the position of the motor and provide that information back to the microprocessor. This would improve user adherence since all the user needs to do is exhale into the device. The device will automatically set and control the resistance setting to achieve the desired therapy. Another option would be to program into the algorithm variations in frequency or pressure as some research has shown to be beneficial.

Feature: Lung Health

Referring toFIG.42, one embodiment includes a flow sensor, which makes it possible to evaluate the patient's lung health by turning off the oscillations and allowing the device to operate like a spirometer. The flow sensor would need to be able to measure flow in both directions (inspiratory and expiratory). An algorithm take the flow being measured and generate a flow-volume loop shown below inFIG.42. From the FV Loop, various parameters may be calculated and fed back to the patient.

Although the present invention has been described with reference to preferred embodiments, those skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the invention. As such, it is intended that the foregoing detailed description be regarded as illustrative rather than limiting and that it is the appended claims, including all equivalents thereof, which are intended to define the scope of the invention.