Many individuals suffer from sinusitis, which is characterized by upper airway mucosal edema, inflammation and obstruction. Normally, the sinuses are filled with air, but inflammation and edema cause obstructions, fluid (e.g., mucus, drainage, etc.) and/or infectious material (e.g., bacteria, viruses, etc.) to accumulate. Sinusitis causes many uncomfortable symptoms, including pain resulting from pressure in the sinus cavities, nasal mucus discharge, headaches, and many others. Accordingly, there is a need to treat sinusitis, including acute, subacute, recurrent and/or chronic sinusitis.
In addition, Eustachian equilibrium may be lost when a person encounters sudden changes in pressure, such as when an airplane takes off and/or lands, which causes the pressure in the ear canals to become unbalanced. There is a need to treat this loss of Eustachian equilibrium that results from sudden changes in pressure.
According to an implementation, described herein, a therapeutic device for treating one or more conditions associated with a user's nasal cavities, sinuses, and/or ear canals, the therapeutic device may include a vibration generator configured to provide a vibration to a nasal interface of the user, the nasal interface located over a nose, around the nose or in the nose of the user. The therapeutic device may also include a gas module configured to provide a gas having a positive pressure to the user at a chamber and a seal configured to maintain the positive pressure at the chamber. The therapeutic device may also include a power module configured to provide power to the vibration generator to create the vibration and a housing which the user may hold and which is connected to the vibration generator, the gas module, and the power module. The therapeutic device may further include a user interface mounted to the housing and operable by the user to control one or more of the following functions of the therapeutic device: increase the positive pressure of the gas; decrease the positive pressure of the gas; modulate the positive pressure of the gas; increase the frequency of the modulation of the positive pressure of the gas; decrease the frequency of the modulation of the positive pressure of the gas; turn on the positive pressure of the gas; turn off the positive pressure of the gas; increase the vibration produced by the vibration generator; or decrease the vibration produced by the vibration generator. The gas module of the therapeutic device may serve as the vibration generator by modulating the positive pressure of the gas. The therapeutic device may further include a medication module configured to provide a medication to the user and a user interface mounted to the housing and operable by the user to control one or more of the following functions of the therapeutic device: turn on the medication module to provide medication to the user; turn off the medication module to stop medication from being provided to the user; increase the amount of medication provided to the user via the medication module; or decrease the amount of medication provided to the user via the medication module. The therapeutic device may include a seal on the housing and/or a chamber located within the housing. The therapeutic device may further include a nasal pillow extending from the housing and connected to the vibration generator. The seal may be located on the nasal pillow, and the chamber may be located within the nostril associated with the nasal pillow. The vibration may be delivered to the user via the nasal pillow, and the nasal pillow may further include ballast. The power module may provide power generated by the breath of the user or a crank operated by the user to the vibration generator to provide the vibration to the user. The power provided by the power module may be electrical power or rotational power. The therapeutic device may further include at least one of a temperature control module to warm the gas or a humidity control module to increase or decrease the humidity of the gas. The gas may correspond to one or more of: air, oxygen, nitrogen, helium, carbon dioxide, water vapor, exhaled breath of the user, or helox. The positive pressure of the gas may be from four to twenty-five centimeters of water or from four to ten centimeters of water. The therapeutic device may include a valve that prevents the positive pressure in the chamber from exceeding a threshold.
According to another implementation, described herein, a manually operated therapeutic device for treating one or more conditions associated with a user's nasal cavities, sinuses, and/or ear canals, may include a vibration generator configured to provide a vibration to a nasal interface of the user, the nasal interface being located over a nose, around the nose or in the nose of the user. The therapeutic device may further include a power module configured to provide power generated by the user to the vibration generator and a gas module configured to provide a gas having a positive pressure to the user at a chamber. The gas module may include a reservoir that may be filled by the exhaled breath of the user to provide the positive pressure of the gas. The therapeutic device may further include a seal configured to maintain the positive pressure at the chamber and a housing that the user may hold and that is connected to the seal, the vibration generator, the power module and the gas module. The power generated by the user may come from the exhaled breath of the user or a crank rotated by the user. The therapeutic device may include a cover.
According to another implementation, described herein, a method for treating one or more conditions associated with a user's nasal cavities, sinuses, and/or ear canals, may include providing a therapeutic device that includes a vibration generator configured to provide a vibration to a nasal pillow located at a nasal interface of the user, the nasal interface located in a nose of the user. The therapeutic device may further include a gas module configured to provide a gas having a positive pressure to the user at a chamber and a seal configured to maintain the positive pressure at the chamber. The method may further include operating the therapeutic device to provide the vibration to the nasal pillow and operating the therapeutic device to provide the gas to the chamber.
According to another implementation, described herein, a therapeutic device for treating one or more conditions associated with a user's nasal cavities, sinuses, and/or ear canals includes a vibration generator that includes an acoustic device configured to provide a sound. The therapeutic device further includes a seal that may be applied to a nasal interface of the user, the nasal interface being located around the nose and/or mouth of the user. The therapeutic device further includes a housing which the user may hold and which is connected to the vibration generator and the seal. The vibration generator may apply the sound to the nasal interface of the user when the seal is applied to the nasal interface of the user. The therapeutic device may further include an air-tight chamber formed within the housing when the seal is applied to the nasal interface of the user and a gas module connected to the housing and configured to provide a positive pressure in the air-tight chamber. The positive pressure may be generated by an exhaled breath of the user. The therapeutic device may further include a poppet valve that limits the positive pressure. The therapeutic device may further include a check valve that prevents a vacuum from being created in the air-tight chamber. The therapeutic device may further include a user interface that is operable by the user to control one or more of the following functions of the therapeutic device: turn the sound on; turn the sound off; increase a sound level produced by the vibration generator; decrease the sound level produced by the vibration generator; increase a frequency of the sound; or decrease the frequency of the sound. The therapeutic device may further include a power module. The power module may be located within the vibration generator. The vibration generator may include a signal source. The vibration generator may receive a signal from an external source, the signal being used by the acoustic device to generate the sound. The acoustic device may be a speaker, an electroacoustic transducer, a tone generator, a tone module, an ultrasonic generator, an ultra-low frequency generator, or a buzzer. The sound may resemble humming. The sound may have a frequency of from about 100 hertz to about 150 hertz. The sound may have a sound level of from about 20 decibels to about 100 decibels. The gas module may produce a vibration.
According to another implementation, described herein, a therapeutic device for treating one or more conditions associated with a user's nasal cavities, sinuses, and/or ear canals includes a vibration generator that includes an acoustic device that converts a signal to a sound. The signal is generated by the vibration generator or an external device. The therapeutic device further includes a housing that the user may hold and that is connected to the vibration generator. The housing is connectable to a nasal interface of the user to provide the sound to the nasal cavities, sinuses and/or ear canals of the user. The therapeutic device may further include a gas module that is connected to the housing and powered by the exhaled breath of the user to provide a positive pressure to the user or to provide a vibration to the user.
According to another implementation, described herein, a method for treating one or more conditions associated with a user's nasal cavities, sinuses, and/or ear canals includes providing a therapeutic device including a vibration generator configured to provide a sound. The method further includes applying the therapeutic device to a nasal interface of the user. The method further includes operating the therapeutic device to apply the sound to the nasal interface of the user. The method may further include exhaling by the user to provide a positive pressure to the nasal interface of the user or to provide a vibration to the nasal interface of the user. The method may further include a sound that has a frequency of from about 100 hertz to about 150 hertz.
According to another implementation, described herein, a therapeutic device for treating one or more conditions associated with a user's nasal cavities, sinuses, and/or ear canals includes a vibration generator that includes an acoustic device operable to provide a sound and a seal configured to cover a nose, but not a mouth, of the user, the seal forming an air-tight chamber around the nose of the user when the seal is applied around the nose of the user. The therapeutic device further includes a housing that is holdable and in which the vibration generator is disposed, the seal connected to the housing. A stand extends from the housing, the stand including a ball bearing and a seat on which the ball bearing may rest. The stand further includes a hollow member and an orifice, the orifice disposed in the seat. When the seal is applied to the nose of the user, a positive pressure is created in the air-tight chamber when the user exhales and the vibration generator provides the sound directly to the nose of the user when the acoustic device is operated to provide the sound such that the sound may travel into the nose of the user to treat the one or more conditions. Further, when the seal is applied to the nose of the user and the user exhales, the positive pressure generates a lift force that passes through the hollow member to the orifice to lift the ball bearing from the seat to limit the positive pressure. The therapeutic device may further include a check valve that prevents a vacuum from being created in the air-tight chamber. The sound may have a frequency of from 100 hertz to 150 hertz. The therapeutic device may further include a power module located within the housing. The vibration generator may include a signal source that provides a signal, the signal being used by the acoustic device to generate the sound. The vibration generator may receive a signal from an external source, the signal being used by the acoustic device to generate the sound. The acoustic device may correspond to at least one of a speaker, an electroacoustic transducer, a tone generator, a tone module, an ultrasonic generator, an ultra-low frequency generator, or a buzzer. The sound may have a sound level of from 20 decibels to 100 decibels. The stand may further include a cap, the ball bearing contacting the cap when the positive pressure creates a lift force that exceeds the weight of the ball bearing.
According to another implementation, described herein, a method for treating one or more conditions associated with a user's nasal cavities, sinuses, and/or ear canals includes providing a therapeutic device including a vibration generator configured to provide a sound, the therapeutic device including a seal configured to provide an air-tight chamber around the nose. The therapeutic device further includes a housing that is holdable and in which the vibration generator is disposed, the seal extending from the housing. A stand extends from the housing, the stand including a ball bearing and a seat on which the ball bearing may rest, the seat including an orifice. A hollow member is disposed in the stand under the orifice. The method includes applying the therapeutic device to cover the nose, but not the mouth, of the user to create an air-tight chamber around the nose of the user and operating the therapeutic device to apply the sound directly to the nose of the user such that the sound can enter the nose of the user. The method further includes exhaling through the nose by the user to create a positive pressure in the air-tight chamber around the nose such that the positive pressure is delivered into the nose of the user, the positive pressure generating a lift force that passes through the hollow member to the orifice to lift the ball bearing from the seat to limit the positive pressure. The housing may further include a cap opposite the ball bearing from the seat, the ball bearing contacting the cap when the positive pressure generates a lift force that exceeds the weight of the ball bearing and contacting the seat when the lift force is reduced below the weight of the ball bearing. The deal may further include a check valve that prevents a vacuum from being created in the air-tight chamber. The method may further include inhaling through the nose by the user, the check valve opening to allow the user to inhale. The vibration generator may include a speaker. The sound may have a sound level of from 20 decibels to 100 decibels or a frequency of from 100 hertz to 150 hertz.
The apparatus, systems, methods, technologies and/or techniques (hereinafter “technology”) described herein may provide a therapeutic device for the treatment of sinus conditions as well as methods by which users use the therapeutic device to treat sinusitis, and various other ailments of the sinuses, nasal cavities, ear, nose throat, etc. The technology may be described in
The therapeutic device may include one or more modules that can impart a controlled amount of vibration to the user, via the nasal interface, in a manner that stimulates the nasal and sinus cavities of the user and/or relieves conditions related to the sinuses, nasal cavities, ears, nose and/or throat. The therapeutic device may also, or alternatively, include one or more modules that may provide a gas to a user, via the nasal interface, in a manner that stimulates the nasal and sinus cavities of the user and/or relieves conditions related to the sinuses, nasal cavities, ears, nose and/or throat. The therapeutic device may also, or alternatively, include one or more modules to control the temperature and/or humidity level of the gas, and/or combine a controlled amount of medication (e.g., in liquid and/or powder form) with the gas. The therapeutic device may include a power module that stores power (e.g., a battery, battery pack, etc.) and/or receives power (e.g., a power supply that receives and/or controls power from an alternating current source), and/or can be manually powered by the user (e.g., by inhaling, exhaling, or some other means of manual power).
Housing 210 may be held by the user when using therapeutic device 120 to treat a sinus condition. Additionally, or alternatively, housing 210 may provide a chamber (e.g. when seal 220 is applied to the nasal interface) that may store a gas at a pressure and/or a medication to be delivered to a user to treat one or more of the conditions described herein. Additionally, or alternatively, one or more of the components of therapeutic device 120 may be permanently and/or removably mounted, installed and/or attached to housing 210 so that therapeutic device 120 may be more compact, convenient and/or be a one-piece design. Housing 210 may enclose one or more of the modules, discussed herein. Housing 210 may include a user interface 211 formed by one or more buttons, levers, displays, touch screens, dials, etc. with which the user may interact to control the therapeutic device (e.g. control vibration; control gas pressure, temperature, flow and/or humidity; medication delivery, etc.). Additionally, or alternatively, user interface 211 may be placed on any other component of therapeutic device 120, including the vibration generator 230, one of the modules, etc. User interface 211 may be a single unit, as displayed in
Housing 210 may further include a valve 212, which may regulate the pressure and/or flow of gas into and/or from a chamber associated with housing 210. For example, and not limitation, valve 212 may correspond to a poppet valve, which may prevent the pressure within the chamber from exceeding a certain threshold associated with an opening pressure of the poppet valve. Additionally, or alternatively, valve 212 may correspond to a check valve, which may prevent a vacuum and/or pressure below ambient pressure from being created (e.g. when the user inhales) within chamber. Additionally, or alternatively, valve may correspond to a pressure regulation and/or flow regulation valve, which may limit the pressure within the chamber and/or the flow rate of a gas into and/or from the chamber.
Housing 210 may be formed from a material or materials of sufficient strength and rigidity (e.g. a polymer, a metal alloy, fiberglass, composite, etc.) to support the static and/or dynamic loads (e.g. forces, torques, tensions, compressions, stresses, strains, etc.) imparted on the housing 210 by the components of therapeutic device 120 (such as when they are installed on housing, apply pressure to housing, etc.), to support the handling of therapeutic device by the user, to support the pressures and/or vibrations imparted to the housing 120 by the user and/or the components of the therapeutic device 120. Seal 220 may be the interface between therapeutic device 120 and the user, so the treatments (e.g. vibrations, pressures, medications, etc.), described herein, may be provided via seal 220 (e.g. vibrations passing through seal 220, pressure passing to user as a result of seal 220, etc.).
Seal 220 may be separate component that is permanently and/or removably attached to housing 210, nasal pillows 240 and/or some other portion of therapeutic device 120 that may create a chamber at the nasal interface of a user. A user may apply the seal 220 (e.g. by grasping housing and pressing seal around a nasal interface) to the user to form a chamber within which a gas (e.g. a pressurized gas, a therapeutic gas, etc.), medication, humidity, etc. may reside prior to being inhaled by the user. Seal 220 may be completely and/or partially air-tight. In the embodiment depicted in
Seal 220 may be formed from a material or materials of sufficient strength and rigidity (e.g. polymers, rubbers, metals, etc.) to support the static and/or dynamic loads (e.g. forces, torques, tensions, compressions, stresses, strains, etc.) imparted on the seal by other components of therapeutic device 120. For example, and not limitation, seal 220 may support vibration loads associated with pressure variation and/or a vibration generation device, may support pressure loads associated with the application of a pressure to the user. Additionally or alternatively, seal 220 may be formed from a material or materials of sufficient flexibility and resilience to be compressed by a user (such as when forming a seal at and/or around the nasal interface) and/or to be comfortably used by the user. For example, seal 220 may be formed from a gasket-like material, which may be comfortable to the user and/or may maintain pressure within a chamber formed by the seal 220. Seal 220 may be removable to allow seal 220 to be cleaned and/or replaced.
Vibration generator 230 may provide mechanical vibrations to the user via the nasal interface (e.g. at seal 220, nasal pillows 240, etc.). Vibration generator 230 may contain one or more mechanical vibration-generating components (e.g., offset weight devices, cam-driven devices, etc.). For example, vibration generator may include one or more electrically driven vibration components, including, but not limited to, an eccentric rotating mass motor, an offset weight motor, a linear resonant actuator, a piezoelectric bender, etc. Additionally, or alternatively, the vibration generator may be mechanically driven. For example, the user may power a vibration device by breathing into the nasal interface. By inhaling and/or exhaling, the user may rotate a set of blades (e.g., a rotor blade, turbine blade, fan blade, etc.) that may be attached to a shaft associated with a mass that is offset from the center of the shaft. As the shaft rotates, the offset weight is rotated which creates a centrifugal force that is applied to the user when, for instance, the shaft is connected to (e.g. the shaft is allowed to rotate in a bearing and transfer the vibration forces, etc.) the nasal interface (e.g. connected to a member associated with nasal pillows 240, seal 220, etc.) Additionally, or alternatively, the user may exhale to fill a reservoir (e.g. such as a reservoir located within gas module 250) with exhaled breath (e.g. through a check valve that allows exhaled air to enter but not escape, etc.), and the pressure created and/or stored within the reservoir may be used (e.g. when another valve is operated, such as controlled by user interface 211, to allow gas to escape the reservoir, etc.) to rotate the set of blades to rotate the shaft that generates the vibration. Additionally, or alternatively, the user may manually operate a shaft (e.g., by operating a crank, etc.) to create vibrations, such as in the ways described herein. The scope of the present disclosure is not limited to the foregoing examples of vibration generation. Any type of known vibration device may be used. For example, an internal mass may be attached to a spring that may be depressed by a shaft that rides along a cam, which may be connected to a shaft that is driven by the user (e.g., the user's breath, by hand, etc.). Transferring the vibrations to the user via a nasal interface may stimulate the nasal and/or sinus cavities in a manner that breaks up and/or loosens liquid, mucus, solids and/or an obstruction within the nasal and/or sinus cavities of the user. Such stimulation may promote drainage of the nasal and/or sinus cavities. Additionally, or alternatively, the vibrations may open the ear canal to relieve pressure from the ear drum, which may be created by an infection, mucus, and/or changes in pressure (e.g., taking off and/or landing in an airplane).
Additionally, or alternatively, vibration generator 230 may be acoustically driven. Vibration generator 230 may include one or more acoustic devices that generate an acoustic vibration and/or a sound (a “sound”). Acoustic device may correspond to any sound generation device, including, for instance, a speaker, an electroacoustic transducer, a tone generator, tone module, ultrasonic generator, ultra-low frequency generator, buzzer, etc. The acoustic device may receive a signal (e.g. electrical signal that is converted to a sound by acoustic device etc.) from power module 260 or some external device and use such signal to generate the sound. Additionally, or alternatively, vibration generator 230 may include a signal source. A user may control the vibration generator 230, such as via the user interface 211, to adjust the sound (i.e. turn the sound on or off, increase the frequency of the sound, decrease the frequency of the sound, increase the sound level of the sound, decrease the sound level of the sound, increase sound pressure, decrease sound pressure, increase vibrations associated with the sound, decrease vibrations associated with the sound, etc.). The sound may correspond to a vibration associated with a change in pressure that may be audible (e.g. within a frequency of about 20 Hertz to about 20,000 Hz, a sound level from about 0 decibels to 100 decibels or more, etc.) or inaudible (e.g. low frequency sound known as infrasound; high frequency sound known as ultrasound, etc.). The sound applied may be depend upon a comfort level of a user (i.e. sound level is not so high that it becomes uncomfortable) and/or usefulness of the sound at producing therapeutic vibrations (e.g. at or near a resonance frequency associated with, for instance, therapeutic device 120, the cilia within a user's sinuses, the bones and/or cartilage of the user's sinuses, etc.). The vibration generator may provide the sound to the user at constant rate or variable rate of amplitude, frequency and/or sound pressure. For example, the sound may resemble humming (e.g. a sound at a frequency of about 100 to 150 Hz, more particularly, from about 115 to about 140 Hertz, etc.) at a range of sound levels (e.g. from about 20 decibels to about 100 decibels). The sound may vary depending upon the amount of congestion in the user, the pressure in the ears of the user, etc. The vibration generator may generate a sound that causes therapeutic device 120, or a portion thereof, to vibrate. These vibrations may be transferred to the user via seal 220 and/or nasal pillows 240. Additionally, or alternatively, sound from the vibration generator 230 may cause vibrations within the user (e.g. cilia in the user's sinuses may vibrate, the bones and cartilage of the sinuses may vibrate, mucus in the user's sinuses may vibrate, etc.).
The sound may be created from a signal generated by the vibration generator 230 when the vibration generator 230 includes a signal source. The signal source may generate one or more signals (e.g. electrical signals, etc.) that are used by the acoustic device of vibration generator 230 to generate the sound waves or patterns of sound waves described herein. The signal source may correspond to, for example, a device that may produce a sound signal (e.g. a tone generator, etc.) or a medium (e.g. a hard drive, a storage medium, etc. that may store digital or analog signals) that may store a signal and an output (e.g. a digital to analog converter, etc.) that may read the signal from the medium and deliver the signal to the acoustic device to generate the sound. The signal may be provided to acoustic device when, for instance, therapeutic device is turned on, when a user controls the user interface to turn the signal on or to modify the signal etc. Additionally, or alternatively, vibration generator 230 may receive a signal, for instance from power module 260 or an external device, that may be used by acoustic device of vibration generator 230 to generate the sound described herein. Vibration generator 230 may also include an amplifier, which may increase the strength of the signal generated and/or received by the vibration generator 230.
Nasal pillows 240 may be one or more members that fit within the nose of the user. Nasal pillows 240 may transfer vibrations to the user, such as vibrations generated by vibration generator 230, pressure module 250, etc. Additionally, or alternatively, nasal pillows 240 may form a seal (e.g. by including a seal, such as seal 220) in the nasal passages of a user to permit a treatment (e.g. a pressurized gas, medication, etc.) to be provided to the user in a chamber within the nose via nasal pillows 240. For instance, nasal pillows 240 may include one or more passageways (e.g. penetrations/tubes, etc.) (not shown) through which medication, pressurized gas, etc. may be transferred from one of the modules, described herein, to the user.
Nasal pillows 240 may include one or more ballast components that are attached to, integrated into and/or formed as part of the nasal pillows. Additionally, or alternatively, ballast components may be attached to, integrated into, and/or formed as a part of another component of therapeutic device 120 associated with transferring vibrations to the user, such as seal 220 or housing 210. Ballast components may be formed by high density materials (e.g., steel, copper, lead, molybdenum, silver, gold, tungsten, platinum, high density polymers such as Ecomass®, high gravity compound ceramics, etc.). The high density materials may be ergonomically shaped to fit in, over, or around the nostrils, nose, mouth and/or face of the user. For example, and not limitation, the high density materials may form a seal (similar to seal 220 except at nasal pillows) within the nostrils of a user. The mass, inertia, and/or momentum of the ballast components may enable vibrations to be imparted to the user via the nasal interface (e.g. at the nasal pillows 240, at seal 220, housing 210, etc.). Ballast components may cause vibrations to be transferred to the user in a manner that causes the nasal and/or sinus cavities of the user to vibrate accordingly. Such vibration may stimulate the nasal and/or sinus cavities in a manner that causes the fluids, mucus, solids and/or other obstructions, within the nasal and/or sinus cavities, to be loosened, drained and/or otherwise removed from the nasal and/or sinus cavities. The vibrational forces provided to the user via ballast components as described above, may be generated by the vibration generator 230, by gas module 250 (e.g. modulated gas pressure may cause the nasal interface and/or the ballast components to vibrate in a manner that imparts the vibrational forces to the user) and/or by another component and/or module of therapeutic device 120 that may generate vibrations as described herein. Nasal pillows 240 may extend from housing 210 (e.g. be connected to housing and/or ballast components associated with housing, etc.), vibration generator 230, gas module 250 (such as when gas module 250 is formed as a part of housing 210, etc.), etc. to the nostrils of user when the user uses therapeutic device 120 as described herein.
Gas module 250 may provide a gas (e.g., air, water vapor, oxygen, nitrogen, helium, helox, carbon dioxide, or a combination of gases, etc.) to a user via the nasal interface (e.g. within a chamber formed by housing 210 and seal 220, within the nostrils via nasal pillows, etc.) at a positive pressure (e.g. above ambient pressure). Gas module 250 may provide gas at different modes, such as a constant mode where a constant pressure is applied when a user inhales, exhales or both; a modulated pressure, where the pressure varies; upon request by the user, etc. Gas module 250 may be connected to (e.g. formed as a part of, via an airtight connection, etc.) housing 210, nasal pillows 240 and/or another component of therapeutic device 120 in a way that allows pressurized gas to be administered to and/or received from the user. Gas module 250 may include to a pressure vessel that may receive, contain, and/or administer a gas at a positive pressure (e.g. above ambient pressure). For example, gas module 250 may include a reservoir that may be filled with a compressed gas that, as further discussed herein, may be regulated to provide the gas to the user at a pressure below the pressure at which the gas is stored in the reservoir. Additionally, or alternatively, gas module 250 may include a pump (e.g. an electric pump, a hand-driven pump, etc.) that may generate pressurized gas, such as compressed air, for use by the therapeutic device 120. Gas module 250 may also, or alternatively, provide pressure to the user that is created when the user exhales. For example, a user may generate a pressure by exhaling (e.g. normally exhaling, exhaling in a manner similar to blowing up a balloon, etc.) into a chamber (e.g. within housing 210, a chamber formed within nostrils by nasal pillows 240, etc.) formed by therapeutic device 120. Gas module 250 may include a valve, such as the poppet valve of housing 210, which may limit the pressure in the chamber, such as by opening to allow gas to escape the chamber. The pressure may be maintained by, for instance, seal 220 and/or nasal pillows 240. The pressure may be stored in the chamber and/or redirected to a reservoir of gas module 250 and used to provide gas pressure to the user (such as when inhaling and/or exhaling) as described herein. Additionally, or alternatively, the gas pressure may be used to create vibrations as described herein.
Gas module 250 may include a regulator (e.g. poppet valves, pressure regulation valves, single stage diaphragm pressure regulators, two stage diaphragm pressure regulators, spring-loaded regulators etc.) to control the pressure and/or rate of flow at which a gas is applied to the user. The pressure regulators may allow gas to be applied to the user at an ideal range of pressures, for example 4-25 centimeters of water (4-25 cm H2O), more ideally 4-10 cm H2O. The pressure regulator may change the pressure applied to the user. The gas module 250 may also, or alternatively, include one or more shutoff valves (e.g., gate valves, ball valves, globe valves, spring loaded shutoff valve, etc.) which may be operable (e.g. by user interface 211, etc.) to start and/or stop the flow of a gas from a gas source (e.g. a source of pressurized gas) to the user.
The gas module 250 may also modulate and/or oscillate the gas pressure applied to the user. Modulating the gas pressure applied to the user may create a gas pressure pulse that travels via the nasal interface into the nasal and/or sinus cavities. The gas module may modulate the gas pressure by controlling the shape of each pressure pulse. Such modulation may include controlling a rate at which the gas pressure rises, levels off, and/or falls as a function of time. The gas module may also, or alternatively, modulate the gas pressure by controlling pulse duration, duration between pulses, frequency of pulses, following a duty cycle associated with the pulses, etc. The modulating gas pressure pulses may break up and/or loosen the fluid, mucus, solids, or other obstructions within the nasal and/or sinus cavities of the user, which may promote drainage of the mucus. To modulate the gas pressure, the gas module 250 (or some other component of therapeutic device 120) may include, for example, a solenoid which may be operable to change the path the gas travels through the gas module 250. The solenoid may change the path of the gas from a first pressure regulator, which provide gas to the nasal interface at one pressure, to a second pressure regulator, which provide gas to the nasal interface at a different pressure and/or to a non-regulated passage through the gas module (which provides the gas at the pressure it is stored/created. Additional regulators (three, four, five, etc.) may be used as well, which may include using three-position (or more) solenoids, multiple solenoids, or other ways of changing the path of the gas through the regulators. In this way, the pressure at which the gas is introduced to the user may be modulated, such as by operating a solenoid. Additionally, or alternatively, the gas module may include one or more pressure regulators which may be configured to switch, in response to an input (automatic and/or manual), between two or more pressures, or between pressure and no pressure (e.g., relative to ambient pressure), to oscillate the pressure of the gas delivered to the user. The gas module may vary the gas pressure and/or frequency of the modulation of gas pressure (e.g. based on a series of modulated pressure pulses associated with a wave form, frequency and/or duty cycle, etc.) to assist with breaking up and/or loosening of the fluid, mucus, solids, and/or obstructions to promote drainage of the nasal and/or sinus cavities and/or to restore Eustachian equilibrium. Varying the pressure of the gas and/or the frequency of modulation of the gas pressure may also, or alternatively, generate a gas-induced vibration, which may be applied to the nasal interface of the user in the same and/or similar fashion as the vibrations generated by vibration generator 230 (e.g. through nasal pillows 240, seal 220, housing 210, etc.). In this embodiment, the gas module 250 may serve as the vibration generator 230 in that the gas module 250 creates vibrations by modulating the pressure applied to the user. Modulating the pressure (or, for instance, operating a solenoid valve) may cause the nasal interface to vibrate. Additionally, or alternatively, gas pressure may be modulated and/or gas vibration may be created by a user when exhaling via the nasal interface into the gas module 250, which may use the pressure generated from the exhale to generate a pressure and/or vibration as further described herein. Accordingly, gas pressure and/or gas-induced vibration may be created and/or controlled, within the therapeutic device based on the inhalation or exhalation of the user, by manual force supplied by the user (e.g., a crank, etc.), and/or automatically the therapeutic device using an external power source (electrical power, etc.).
Power module 260 may include one or more power generation and/or power supply components. For example, power module 260 may include, for instance, a battery (e.g. a conventional direct current (DC) battery, etc.), a connection to an alternating current (AC) power source, such as a wall outlet, etc. Additionally, or alternatively, power module 260 may include manually powered devices that may be used to provide treatment as further described herein. For example, and not limitation, power module 260 may include a crank (e.g. a handle attached to a shaft, etc.) that may be used by a user to provide rotational energy (e.g. by turning the handle) to vibration generator 230. Vibration generator 230 may convert the rotational energy (e.g. energy from a rotating shaft) into vibrations, which may be applied to the nasal interface of the user. Additionally, or alternatively, power module 260 may include a turbine device (not shown) that generates rotational energy when the user exhales (e.g. the user exhales into, for example, housing 210 and the exhaled breath evacuates housing 210 across blades associated with the turbine device, etc.). The rotational energy from turbine device may be provided to vibration generator 230 to produce vibrations. Additionally, or alternatively, the power module 260 may include a balloon device which may be inflated by the user (e.g. by exhaling into therapeutic device 120, etc.). Balloon device may store pressure that may be used to obtain rotational energy from, for instance, turbine device. In addition to providing power to generate vibrations, power module 260 may provide power to, for instance, the user interface 211, valve 212 and associated components of housing 210, the gas module 250, medication module 270 and/or any other components of therapeutic device 120 that require electrical, mechanical, electromechanical, hydraulic, etc. power. Power module 260 may also, or alternatively, provide a signal to vibration generator 230, which signal may be used by the vibration generator 230 to generate a sound.
Medication module 270 may provide liquid, atomized, vaporized and/or powdered medication to the gas. The medication module may be connected to therapeutic device 120 (e.g. to gas module 250, housing 210, nasal pillows 240, etc.) via an air-tight connection (e.g., a hollow tube, manifold, a tee into a line associated with the gas module, etc.). The medication module may regulate the flow and/or dosage of medication, such as with a metering device, a nozzle associated with a certain cross section, etc. The medication module may include a mixing valve, a nozzle, injector, etc., which may vaporize, atomize and/or separate the medication prior to, during, and/or after the medication is applied to the user (e.g. applied directly to the user, mixed with gas from gas module 250 before being applied to user, etc.). Additionally, or alternatively, the mixing valve may uniformly distribute the medication within the gas.
The therapeutic device 120 may also, or alternatively, provide a temperature control module (not shown) which may warm, cool or otherwise control the temperature of the gas and/or medication delivered to the user via the nasal interface. The temperature control module may be connected to the gas module and/or the medication module via an air-tight connection (e.g., a tee into a line associated with the gas module and/or medication module, etc.). The temperature control module may include a heat exchanger which may apply heat to the gas and/or the medication to raise the temperature of the medication and/or the gas entering the nasal interface. Additionally, or alternatively, the temperature control module may utilize electrical resistors, which may convert electrical energy into heat energy, and which may apply heat to the gas and/or the medication to raise the temperature of the gas and/or medication. The temperature control module may cause a portion of the exhaled gas breathed by a user to be diverted to the gas that is be conditioned to be provided to the user via the nasal interface.
The therapeutic device 120 may also, or alternatively, include a moisture control module (not shown) to provide humidified gas to the user via the nasal interface. The moisture control module may be connected to the therapeutic device via an airtight connection (e.g., a manifold, a tee in one of the lines associated with the therapeutic device, etc.). The moisture control module may combine moisture (e.g., tap water, distilled water, vapor, etc.) with the gas, medication and/or both. Increasing the moisture and/or humidity of the gas entering the nasal interface may enable the membranes within the nostrils, throat, and/or mouth to remain moist and/or to lubricate the nasal and sinus cavities of the patent. Increasing the moisture and/or humidity of the gas may also, or alternatively, break up and/or loosen the fluid, mucus, solids or obstructions within the nasal and/or sinus cavities of the user, which may promote drainage of the mucus. The moisture control module may include a humidifier (e.g., evaporative humidifier, impeller humidifiers, vaporizers, atomizing nozzles, ultrasonic humidifiers, forced-air humidifiers, etc.) which may increase the humidity of the gas entering the nasal interface.
The systems and/or methods may enable the therapeutic device to administer one or more therapies to a user to treat a sinus and/or nasal condition and/or one or more symptoms associated with sinusitis (e.g., inflammation, edema, pain resulting from pressure in the sinus cavities, nasal mucus discharge, headaches, etc.) and/or to restore Eustachian equilibrium. For example, a user may position a nasal interface on, over, within, or around the nose and/or mouth of the user. In one embodiment, the nasal interface may include two nasal pillows, which may be positioned inside of the nose of the user. Additionally, or alternatively, the nasal interface may include a housing that may be placed around the nostrils and/or mouth of the user. When the user positions the nasal interface around and/or inside the nose, the nasal interface may create a seal that may maintain a pressure that may be applied to the user via the nasal interface. A chamber may be formed by applying the seal to the nasal interface of the user.
The user may operate the therapeutic device (e.g., by flipping a switch, opening a valve, pressing a button, etc.) to cause the gas module to apply a gas (e.g., air, oxygen, nitrogen, helium, helox, a combination of gasses, etc.) contained within and/or created by a gas source to the nasal interface. The gas module may include one or more pressure regulators which may regulate the gas applied to the nasal interface to be within a pressure range (e.g., 4-25 cm H20). Additionally, or alternatively, the gas module may automatically and/or by input from the user (e.g., by pressing a button, entering a preferred setting, etc via the user interface) modulate and/or oscillate the pressure at which the gas is applied to the nasal interface and may vary the frequency at which the pressure is modulated and/or oscillated. The modulation and/or oscillation of the gas pressure applied to the user at the nasal interface may cause a gas pulse and/or gas vibration, the frequency of which may by changed (e.g., increased, decreased, or varied) by the gas module.
Gas may flow from the gas module to the nasal interface. The seal may maintain the pressure created at the nasal interface by the application of the gas by the gas module. A valve may limit the pressure created at the nasal interface and/or may prevent the pressure within a cavity from exceeding a limit (such as when the user exhales into cavity). Additionally, or alternatively, the gas module and/or the seal may maintain a specific pressure at the nasal interface when the user inhales and/or exhales. The pressure applied to the user by the gas, as well as pressure changes resulting from the modulated gas pressure and/or exhaling by the user, may break up and/or loosen mucus within the nasal and/or sinus cavities of the user, which may promote drainage of the mucus and/or may treat one or more symptoms associated with sinusitis (e.g., inflammation, edema, pain resulting from pressure in the sinus cavities, nasal mucus discharge, headaches, etc.) and/or may restore Eustachian equilibrium.
The gas module may also, or alternatively, apply a positive pressure to the nasal interface of the user by capturing pressure resulting from the exhaled breath of a user within a cavity inside of housing. The cavity may be formed when the seal is applied to the nasal interface of the user, which may create an air-tight vessel in housing. The pressure may be applied to the user only when exhaling (i.e. restricting the ability to exhale, which creates pressure, etc.) or when the exhaling and inhaling. The gas module may also, or alternatively, use the exhaled breath of the user to provide a vibration to the nasal interface of the user.
The therapeutic device may cause the nasal interface to mechanically vibrate and thereby transfer vibratory forces to the face, nose, and/or mouth, as well as the nasal and/or sinus cavities of user. The user may provide input to the therapeutic device, e.g. via a user interface, to control the strength and/or rate of the vibration. Such control may enable the user to increase, decrease or maintain the vibratory forces that are imparted on the user. Mechanical vibration may be applied to the user along with and/or without the gas pressure from the gas module.
The vibration generator may include an acoustic device that may generate a sound and/or sound-driven vibration (a “sound”) that causes the nasal interface and/or the user's sinuses (e.g. the user's cilia, the nasal passages, and/or bone, cartilage, etc. within the sinuses, etc.) to vibrate. The sound may be applied to the user at or near the nasal interface. The user may operate the therapeutic device, e.g. via user interface, to turn the sound on or off, to control the frequency, sound level and/or sound pressure of the sound generated by the acoustic device, which may control the amount of sound and/or vibration applied to the user. Such control may enable the user to increase, decrease or maintain the vibratory forces and/or sound imparted to the user. Additionally, or alternatively, a user may operate the therapeutic device to allow a signal to be provided to the vibration generator (e.g. by connecting the therapeutic device to an external source that may provide the signal to the vibration generator, etc.). The sound may be applied at any range of frequencies, sound levels, sound pressures, etc., including sound that resembles humming (e.g. having a frequency from about 100 hertz to about 150 hertz, etc.). Acoustic vibration and/or sound may be applied to the user with and/or without gas pressure from the gas module and with and/or without treatment from other modules discussed herein.
The user may operate a medication module (e.g., by interacting with the user interface, depressing a button on medication module, etc.) of the therapeutic device to apply a medication (e.g., vaporized medications, powdered medications, etc.) to the user. The medication may break up and/or loosen mucus within the nasal and/or sinus cavities of the user, which may promote drainage of the mucus and/or may treat one or more symptoms associated with sinusitis (e.g., inflammation, edema, pain resulting from pressure in the sinus cavities, nasal mucus discharge, headaches, etc.). The medication module may apply medication to the nasal interface with or without gas from the gas module. The medication module may vaporize and/or separate medication before it is applied to the nasal interface. The medication module may uniformly mix the medication with the gas.
The user may operate a temperature module to increase and/or decrease the temperature of the gas and/or the medication applied to the user at the nasal interface. The temperature control module may apply heat to the gas, the medication, or both before it enters the nasal interface. Increasing and/or decreasing the temperature of the gas and or medication may break up and/or loosen mucus within the nasal and/or sinus cavities of the user, which may promote drainage of the mucus, and/or may treat one or more symptoms associated with sinusitis (e.g., inflammation, edema, pain resulting from pressure in the sinus cavities, nasal mucus discharge, headaches, etc.)
The user may operate a humidity module to increase and/or decrease the humidity of the gas, the medication or both applied to the user at the nasal interface. Increasing the humidity of the gas, the medication or both may break up and/or loosen mucus within the nasal and/or sinus cavities of the user, which may promote drainage of the mucus, and/or may treat one or more symptoms associated with sinusitis.
The user may operate a power module which may provide mechanical power used to generate vibrations (e.g. via a vibration generator) to be delivered to the user via the nasal interface. The vibrations may break up and/or loosen mucus within the nasal and/or sinus cavities of the user, which may promote drainage of the mucus. Additionally, or alternatively, the vibrations may open the ear canal to relieve pressure from the ear drum, which may be created by an infection, mucus, and/or changes in pressure (e.g., taking off and/or landing in an airplane). In another embodiment, the power module may include a manually driven (e.g., by the user's breath, the user's hand, etc.) vibration device, may be shaped like a child's toy (e.g., an elephant, a giraffe, a superhero, etc.) and may be used by children to alleviate the discomfort associated with the loss of Eustachian equilibrium, such as during air travel.
The components of therapeutic device 400 may function the same as, or similar to, the similarly numbered components of therapeutic device 120 described in
In one particular implementation of therapeutic device 400, vibration generator 430 may be acoustically driven and may generate a sound that may be provided to the user. The vibration generator 430 may include an acoustic device that may generate the sound. The acoustic device may receive a signal from a signal source. The signal source may be included in vibration generator 430. When signal source is included in vibration generator 430, a user may vary the signal generated by signal source, such as by adjusting controls on user interface 411. Additionally, or alternatively, signal source may be included in another component of therapeutic device 400, such as power module 460, or may be an external source of electrical signals that may be converted into a sound by acoustic device of vibration generator 430. The external source may be, for instance, a signal jack (e.g. speaker jack, headphone jack, etc.) of another device (e.g. a computer, a smart phone, a tablet, an amplifier, a stereo, a signal generator, etc.) that outputs signals used to generate sounds. Power module 460 may provide electrical signals (e.g. power generator may be signal source) and/or electrical power (e.g. electrical power used by, for instance, signal source of vibration generator 430, acoustic device of vibration generator 430, an amplifier of vibration generator 430, etc.) to vibration generator 430. Power module 460 may be separate from, or formed as a part of, vibration generator 430. Alternatively, therapeutic device 400 may function without power generator 460, such as when therapeutic device 400 receives a signal from an external source.
The particular implementation of therapeutic device 400 may further include gas module 450. Gas module 450 may provide a positive pressure (i.e. above ambient pressure) to the user when the user exhales and may also, or alternatively, provide a mechanical vibration to the user. Gas module 450 may be any mechanism, assembly or device that may provide a positive pressure to a user and/or a vibration to a user that is created using pressure. For example, in the embodiment depicted in
As the user exhales, positive pressure in the chamber may generate a lift force (i.e. proportional to the pressure applied to the ball bearing 453 and the surface area of the ball bearing 453 to which the pressure is applied) that is applied the ball bearing 453 proximate the seat 452. When the lift force exceeds the weight of the ball bearing 453, the ball bearing 453 may be lifted from seat 452, thereby allowing the exhaled breath of the user to escape the chamber. The ball bearing 453 may lift from seat 452 until it contacts cap 454, particularly the upper surface 455 of cap 454, or until the lift force is less than the weight of ball bearing 453. In this way, the weight of the ball bearing 453 may be used to set the maximum pressure of the chamber. Additionally, or alternatively, cap 454 may be adjusted to limit the distance ball bearing 453 may rise from seat 452, which may increase the maximum pressure of the chamber by limiting the amount of exhaled breath that may pass between ball bearing 453 and seat 452. Cap 454 may be adjustable, such as via a connection (e.g. threaded connection, press fit connection, etc.) between cap 454 and stand 451. Cap 454 may include a vent 456 that may be an opening that allows the exhaled breath of the user to escape gas module 450.
When the lift force is less than the weight of the ball bearing 453, the ball bearing 453 may fall back to seat 452, preventing the exhaled breath of the user from escaping the chamber of housing 410 until the lift force exceeds the weight of ball bearing 453. When ball bearing 453 falls back to seat 452, a vibration may be generated. Additionally, or alternatively, when ball bearing 453 contacts the upper surface 455 of cap 454 (e.g. as a result of the lift force), a vibration may be generated. Accordingly, as the user exhales, the ball bearing 453 may oscillate (i.e. rise and fall) to create vibrations that may be applied to the user via at the nasal interface. These vibrations may be applied to the user in addition to the positive pressure resulting from exhaling into the housing and also in addition to the vibrations applied to the user as a result of sound generated by the vibration generator 430. The positive pressure and vibrations may treat a condition of the sinuses, nasal cavities, ears, nose and/or throat.
The foregoing description provides illustration and description, but is not intended to be exhaustive or to limit the implementations to the precise form disclosed. Modifications and variations are possible in light of the above disclosure or may be acquired from practice of the embodiments.
It will be apparent that the apparatus, systems, methods, technologies and/or techniques, as described above, may be implemented in many different forms of hardware and/or software in the implementations described herein and illustrated in the figures. The actual or specialized hardware and/or materials used to implement the apparatus, systems, methods, technologies and/or techniques is not limited to the embodiments; it should be understood that hardware, software and/or materials may be designed to implement the apparatus, systems, methods, technologies and/or techniques based on the description herein.
It should be emphasized that the terms “comprises”/“comprising” when used in this specification are taken to specify the presence of stated features, integers, steps or components but does not preclude the presence or addition of one or more other features, integers, steps, components, or other groups thereof.
Even though particular combinations of features are recited in the claims and/or disclosed in the specification, these combinations are not intended to limit the disclosure of the embodiments. In fact, many of these features may be combined in ways not specifically recited in the claims and/or disclosed in the specification. Although each dependent claim listed below may directly depend on only one other claim, the disclosure of the embodiments includes each dependent claim in combination with every other claim in the claim set.
No element, act or instruction used in the present application should be construed as critical or essential to the embodiments unless explicitly described as such. Also, as used herein, the articles “a” and “an” are intended to include one or more items and may be used interchangeably with “one or more.” Where only one item is intended, the term “one” or similar language is used. Further, the phrase “based on” is intended to mean “based, at least in part, on” unless explicitly stated otherwise.
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Parent | PCT/US2017/051484 | Sep 2017 | US |
Child | 15891019 | US |