External auditory canal pressure regulating device

Abstract

The present disclosure relates to an external auditory canal pressure regulating device. A fluid transfer device for treating headache symptoms, the fluid transfer device comprising: a fluid flow generator, the fluid flow generator being configured to generate a fluid flow through an earpiece to achieve an external auditory canal pressure difference between the external auditory canal pressure and the ambient pressure; and a valved conduit, the valved conduit being in fluid communication with the fluid flow generator, the valved conduit having a first configuration and a second configuration; wherein the fluid flow generator is configured to achieve a positive pressure difference when the valved conduit is in the first configuration; wherein the fluid flow generator is configured to achieve a negative pressure difference when the valved conduit is in the second configuration; and wherein the external auditory canal pressure difference can effectively treat the headache symptoms.

Description

[0001] This application is a divisional application of the invention patent application with application number 201810441770.8, application date June 25, 2014, and invention name “External auditory canal pressure regulating device”. The aforementioned invention patent application is a divisional application of the invention patent application with application number 201480042665.7 (international application number PCT / US2014 / 044159), international application date June 25, 2014, and invention name “External auditory canal pressure regulating device”. Technical Field

[0002] The present application relates to an external auditory canal pressure regulating device. Background Art

[0003] The pain or discomfort associated with conditions including neurologically mediated conditions such as craniofacial pain symptoms or headache symptoms can negatively impact the patient's quality of life. In addition to the burden on the individual, chronic neurological diseases can also significantly harm family members, employers, and the health care system.

[0004] With regard to migraine, associated symptoms such as pain, nausea, aura, photophobia, dysesthesia, dizziness, vertigo, and imbalance can represent a significant burden on the population. Epidemiological studies have shown that in the United States, approximately 18% of women and 6% of men experience frequent migraines, and 2% of the general population suffers from chronic migraines. In addition, people with chronic migraines or other headaches of similar severity and disability may be at significantly greater risk. Thus, clinicians and researchers are cautiously continuing to search for effective devices and methods to alleviate the symptoms associated with these conditions or to treat the conditions.

[0005] Standard drug therapy for migraine can generally be prescribed to prevent pain or relieve pain. Various agents falling under these two major categories can show a wide range of effectiveness and also cause varying degrees of side effects. From an economic perspective, the cost of these drugs may be a major source of economic burden for consumers. Moreover, advanced interventions such as botulinum toxin injections, nerve blocks, neurosurgical lesions, and implantable electrical stimulators may significantly increase the costs associated with treatment while subjecting patients to potential changes in anatomy and physiology without guaranteeing complete or permanent relief of symptoms or regression of symptoms.

[0006] There is an emerging field of understanding and application within neuroscience that seeks to affect positive physiological changes in the nervous system through non-pharmacological and non-surgical applications. This field of "functional neurology" views the human nervous system as a receptor-driven system that can be activated and stimulated in specific ways to produce adaptive long-term changes through the process of neuroplasticity. This approach to neurorehabilitation utilizes, but does not necessarily include only, various forms and patterns of receptor activation or deactivation to promote positive neurophysiological adaptations within the central nervous system, including the brain, brainstem, and spinal cord, which can promote the physiological function of associated tissues, organs, and systems.

[0007] It would be of considerable advantage to provide a device or method that could generate one or more stimuli that could alleviate one or more symptoms associated with a condition, such as craniofacial pain symptoms or headache symptoms, or treat one or more conditions. Summary of the invention

[0008] A broad purpose of a specific embodiment of the present invention may be to provide an external auditory canal pressure regulating device, which includes: a fluid flow generator that generates a fluid flow; a valved conduit connected to the fluid flow generator in a fluid manner, the valved conduit having a first fluid flow conduit that can be interrupted by one or more valves to unidirectionally regulate the fluid flow in the first fluid flow conduit; and an earpiece, the earpiece having an axial earpiece hole connected between a first end of the earpiece and a second end of the earpiece, the axial earpiece hole being fluidically connected to the valved conduit opposite to the fluid flow generator, the earpiece having a compatible earpiece outer surface, the compatible earpiece outer surface being configured to sealably engage the external auditory canal as a barrier between the external auditory canal pressure and the ambient pressure.

[0009] Another broad object of a specific embodiment of the present invention may be to provide an external auditory canal pressure regulating device, which has a valved pipe, which is connected to the fluid flow generator and the earpiece in a first structure to unidirectionally regulate the fluid flow in the first fluid flow pipe in a first direction, so that the fluid flow can be discharged from the axial earpiece hole of the earpiece to the external auditory canal, thereby achieving an external auditory canal pressure greater than the ambient pressure.

[0010] Another broad object of a specific embodiment of the present invention may be to provide an external auditory canal pressure regulating device, which has a valved pipe, which is connected to the fluid flow generator and the earpiece in a second structure to unidirectionally regulate the fluid flow in the first fluid flow pipe in a second direction, so that the fluid flow can enter the axial earpiece hole of the earpiece from the external auditory canal, thereby achieving an external auditory canal pressure lower than the ambient pressure.

[0011] Another broad object of a specific embodiment of the present invention may be to provide an external auditory canal pressure regulating device having a valved conduit that is removably coupled to the fluid flow generator and the earpiece. The valved conduit may be coupled to the fluid flow generator and the earpiece in the first configuration to unidirectionally regulate the fluid flow in the first direction in the first fluid flow conduit. In addition, the valved conduit may be coupled to the fluid flow generator and the earpiece in the second configuration to unidirectionally regulate the fluid flow in the first fluid flow conduit in the second direction.

[0012] Another broad object of a specific embodiment of the present invention may be to provide a method for producing an external auditory canal pressure regulating device, the method comprising: providing a fluid flow generator capable of generating a fluid flow; providing a valved conduit capable of being fluidically connected to the fluid flow generator, the valved conduit having a first fluid flow conduit; providing one or more valves, the one or more valves capable of interrupting the first fluid flow conduit to unidirectionally regulate the fluid flow in the first fluid flow conduit; and providing an axial earpiece hole, the axial earpiece hole being connected between an earpiece first end and an earpiece second end of the earpiece, the axial earpiece hole being fluidically connected to the valved conduit opposite to the fluid flow generator, the earpiece having a compatible earpiece outer surface, the compatible earpiece outer surface being configured to sealably engage the external auditory canal as a barrier between the external auditory canal pressure and the ambient pressure.

[0013] Another broad object of a specific embodiment of the present invention may be to provide a method for using an external auditory canal pressure regulating device, the method comprising: obtaining an external auditory canal pressure regulating device, the external auditory canal pressure regulating device comprising a fluid flow generator that generates a fluid flow; a valved conduit fluidically connected to the fluid flow generator, the valved conduit having a first fluid flow conduit that can be interrupted by one or more valves to unidirectionally regulate the fluid flow in the first fluid flow conduit; and an earpiece, the earpiece having an axial earpiece hole connected between a first end of the earpiece and a second end of the earpiece, the axial earpiece hole fluidically connected to the valved conduit opposite to the fluid flow generator, the earpiece having a compatible earpiece outer surface configured to sealably engage the external auditory canal as a barrier between the external auditory canal pressure and the ambient pressure; making the earpiece outer surface of the earpiece sealably engageable with the external auditory canal; generating the fluid flow between the fluid flow generator and the axial earpiece hole; and regulating the pressure difference between the external auditory canal pressure and the ambient pressure.

[0014] Naturally, other objects of the invention are disclosed elsewhere in the description, drawings and claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Figure 1A A specific embodiment of an external auditory canal pressure regulating device sealably engaged with the external auditory canal is illustrated.

[0016] Figure 1B A specific embodiment of an external auditory canal pressure regulating device sealably engaged with the external auditory canal is illustrated.

[0017] Figure 2A It is a schematic diagram of a specific embodiment of an external auditory canal pressure regulating device that can be operated to achieve an external auditory canal pressure greater than the ambient pressure.

[0018] Figure 2B It is a schematic diagram of a specific embodiment of an external auditory canal pressure regulating device that can be operated to achieve an external auditory canal pressure lower than the ambient pressure.

[0019] Figure 3A is a cross-sectional view of a specific embodiment of a valve that may be utilized in an embodiment of an external auditory canal pressure regulating device.

[0020] Figure 3B is a cross-sectional view of a specific embodiment of a valve that may be utilized in an embodiment of an external auditory canal pressure regulating device.

[0021] Figure 3C is a cross-sectional view of a specific embodiment of a valve that may be utilized in an embodiment of an external auditory canal pressure regulating device.

[0022] Figure 3D is a cross-sectional view of a specific embodiment of a valve that may be utilized in an embodiment of an external auditory canal pressure regulating device.

[0023] Figure 3E is a cross-sectional view of a specific embodiment of a valve that may be utilized in an embodiment of an external auditory canal pressure regulating device.

[0024] Figure 4A The figure shows a specific implementation of the external auditory canal pressure regulating device.

[0025] Figure 4B The figure shows a specific implementation of the external auditory canal pressure regulating device.

[0026] Figure 4C The figure shows a specific implementation of the external auditory canal pressure regulating device.

[0027] Figure 4D The figure shows a specific implementation of the external auditory canal pressure regulating device.

[0028] Figure 4E The figure shows a specific implementation of the external auditory canal pressure regulating device.

[0029] Figure 4F The figure shows a specific implementation of the external auditory canal pressure regulating device.

[0030] Figure 4G Picture shows Figure 4F A specific embodiment of the external auditory canal pressure regulating device is shown, in which the earpiece is disconnected from the fluid flow generator and the conduit body.

[0031] Figure 4H The figure shows a specific implementation of the external auditory canal pressure regulating device.

[0032] Fig. 4I The figure shows a specific implementation of the external auditory canal pressure regulating device.

[0033] Figure 5 is a cross-sectional view of a specific embodiment of an external auditory canal pressure regulating device that is operable to achieve an external auditory canal pressure greater than ambient pressure.

[0034] Figure 6 is a cross-sectional view of a specific embodiment of an external auditory canal pressure regulating device operable to achieve an external auditory canal pressure less than ambient pressure.

[0035] Figure 7 yes Figure 5 An exploded view of a specific embodiment of an external auditory canal pressure regulating device operable to achieve an external auditory canal pressure greater than ambient pressure is shown.

[0036] Figure 8 A first configuration of an external auditory canal pressure regulating device operable to achieve an external auditory canal pressure greater than ambient pressure is illustrated.

[0037] Fig. 9 Illustration of reconfiguration by rotating the pipe body end-to-end Figure 8 A first construction method of an external auditory canal pressure regulating device is shown.

[0038] Fig.10 A second configuration of the external auditory canal pressure regulating device operable to achieve an external auditory canal pressure lower than ambient pressure by rotating the conduit body end-to-end is illustrated.

[0039] Fig.11A A first configuration of an external auditory canal pressure regulating device having an outer surface of an earpiece sealably engageable with the external auditory canal is illustrated.

[0040] Fig. 11B The diagram illustrates a first construction of an external auditory canal pressure regulating device, which has an outer surface of an earpiece that can be sealably engaged with the external auditory canal and has a fluid flow generator in a deformed state, which generates sufficient pressure in a valved conduit to place a first valve in an open state to provide a fluid flow toward the external auditory canal to achieve an external auditory canal pressure greater than the ambient pressure.

[0041] Fig. 11C The diagram illustrates a first construction of an external auditory canal pressure regulating device having an outer surface of an earpiece sealably engaged with the external auditory canal and having a fluid flow generator that returns to a non-deformed state, the fluid flow generator generating sufficient pressure to place a first valve in a closed state to maintain external auditory canal pressure, and to place a second valve in an open state to generate a fluid flow from ambient pressure toward the fluid flow generator.

[0042] Fig.11D The diagram illustrates a first construction of an external auditory canal pressure regulating device, which has an outer surface of an earpiece that can be sealably engaged with the external auditory canal and has a third valve. The third valve is manually placed in an open state by operating a pressure relief element to generate a fluid flow from the external auditory canal toward the ambient pressure to restore the external auditory canal pressure to the ambient pressure.

[0043] Fig. 12A A second configuration of the external auditory canal pressure regulating device having an outer surface of the earpiece sealably engageable with the external auditory canal is illustrated.

[0044] Fig. 12B The diagram illustrates a second construction of an external auditory canal pressure regulating device having an outer surface of an earpiece sealably engaged with the external auditory canal and having a fluid flow generator in a deformed state, the fluid flow generator generating sufficient pressure in the valved conduit to place the second valve in an open state to provide a fluid flow toward ambient pressure while maintaining the external auditory canal pressure at ambient pressure.

[0045] Fig. 12C The diagram illustrates a second construction of an external auditory canal pressure regulating device, which has an outer surface of an earpiece that can be sealably engaged with the external auditory canal and has a fluid flow generator that returns to a non-deformed state, the fluid flow generator generating sufficient pressure to place the first valve in an open state and the second valve in a closed state to generate a fluid flow from the external auditory canal toward the fluid flow generator, thereby generating an external auditory canal pressure that is less than the ambient pressure.

[0046] Fig.12D The diagram illustrates a second construction of an external auditory canal pressure regulating device, which has an outer surface of an earpiece that can be sealably engaged with the external auditory canal and has a third valve, which is manually placed in an open state by operating a pressure relief element to generate a fluid flow from ambient pressure toward the external auditory canal to restore the external auditory canal pressure to the ambient pressure.

[0047] Fig.13A is a top view of a specific embodiment of the external auditory canal pressure regulating device.

[0048] Fig. 13BIt is a side view of a specific embodiment of the external auditory canal pressure regulating device.

[0049] Fig. 13C It is a disassembled view of a specific implementation of the external auditory canal pressure regulating device.

[0050] Fig.13D It is a disassembled view of a specific implementation of the external auditory canal pressure regulating device.

[0051] Fig.13E yes Fig.13A A cross-sectional view of a specific embodiment of an external auditory canal pressure regulating device operable to generate an external auditory canal pressure greater than ambient pressure is shown.

[0052] Fig.13F is a cross-sectional view of a specific embodiment of an external auditory canal pressure regulating device operable to generate an external auditory canal pressure less than ambient pressure.

[0053] Fig.14A It is a drawing of the external auditory canal pressure achieved within a period of time relative to the ambient pressure, which represents a method of using a first construction of an external auditory canal pressure regulating device, wherein operating a fluid flow generator generates and maintains a substantially constant external auditory canal pressure (greater than the ambient pressure) at a maximum pressure within a period of time, and by operating a pressure relief element, the external auditory canal pressure is restored to the ambient pressure.

[0054] Fig. 14B It is a plot of the external auditory canal pressure achieved within a period of time relative to the ambient pressure, which represents a method of using a first construction of an external auditory canal pressure regulating device, wherein operating a fluid flow generator by intermittent operation of a pressure relief element generates a pulsating external auditory canal pressure (greater than the ambient pressure), and the pressure wave is a sinusoidal wave with smooth, repetitive periodic oscillations.

[0055] Fig. 14C It is a drawing of the external auditory canal pressure achieved within a period of time relative to the ambient pressure, which represents a method of using a first construction of an external auditory canal pressure regulating device, wherein operating a fluid flow generator by intermittent operation of a pressure relief element generates a pulsating external auditory canal pressure (greater than the ambient pressure), and the pressure wave is a truncated wave in which the apex of the pressure wave has a constant pressure within a period of time.

[0056] Fig.14D It is a plot of the external auditory canal pressure achieved over a period of time relative to the ambient pressure, which represents a method of using a first construction of an external auditory canal pressure regulating device, wherein operating a fluid flow generator by intermittent operation of a pressure relief element generates a pulsating external auditory canal pressure (greater than the ambient pressure), and the pressure wave is a triangular wave with linear leading and trailing edges.

[0057] Fig.14Eis a plot of the external auditory canal pressure achieved over a period of time relative to the ambient pressure, which represents a method of using a first construction of an external auditory canal pressure regulating device, wherein operating a fluid flow generator using intermittent operation of a pressure relief element generates a pulsating external auditory canal pressure (greater than the ambient pressure), and the pressure wave is a sawtooth wave that causes the leading edge to change pressure over a period of time greater than the period of time that causes the trailing edge to change pressure.

[0058] Fig.14F It is a drawing of the external auditory canal pressure achieved within a period of time relative to the ambient pressure, which represents a method of using a first construction of an external auditory canal pressure regulating device, wherein operating a fluid flow generator by intermittent operation of a pressure relief element generates a pulsating external auditory canal pressure (greater than the ambient pressure), and the pressure wave is a truncated wave in which the apex of the pressure wave has a constant pressure within a period of time.

[0059] Figure 14G is a plot of external auditory canal pressure achieved over a period of time relative to ambient pressure, which represents a method of using a first construction of an external auditory canal pressure regulating device, wherein operating a fluid flow generator using intermittent operation of a pressure relief element generates a pulsating external auditory canal pressure (greater than ambient pressure).

[0060] Fig.15A It is a drawing of the external auditory canal pressure achieved during a period of time relative to the ambient pressure, which represents a method of using a second construction of the external auditory canal pressure regulating device, wherein operating the fluid flow generator generates and maintains a substantially constant external auditory canal pressure (less than the ambient pressure) at a maximum pressure during a period of time, and by operating the pressure relief element, the external auditory canal pressure is restored to the ambient pressure.

[0061] Fig. 15B It is a plot of the external auditory canal pressure achieved within a period of time relative to the ambient pressure, which represents a method of using a second construction of the external auditory canal pressure regulating device, wherein operating a fluid flow generator by intermittent operation of a pressure relief element generates a pulsating external auditory canal pressure (less than the ambient pressure), and the pressure wave is a sinusoidal wave with smooth, repetitive periodic oscillations.

[0062] Fig. 15C It is a drawing of the external auditory canal pressure achieved within a period of time relative to the ambient pressure, which represents a second constructed method of using the external auditory canal pressure regulating device, wherein operating the fluid flow generator by intermittent operation of the pressure relief element generates a pulsating external auditory canal pressure (less than the ambient pressure), and the pressure wave is a truncated wave in which the apex of the pressure wave has a constant pressure within a period of time.

[0063] Fig.15Dis a plot of the external auditory canal pressure achieved over a period of time relative to the ambient pressure, which represents a method of using a second construction of the external auditory canal pressure regulating device, wherein operating a fluid flow generator by intermittent operation of a pressure relief element generates a pulsating external auditory canal pressure (less than the ambient pressure), and the pressure wave is a triangular wave with a linear leading edge and a trailing edge.

[0064] Fig.15E is a plot of the external auditory canal pressure achieved within a time period relative to the ambient pressure, which represents a second constructed method of using the external auditory canal pressure regulating device, wherein operating the fluid flow generator by intermittent operation of the pressure relief element generates a pulsating external auditory canal pressure (less than the ambient pressure), and the pressure wave is a reverse sawtooth wave that causes the leading edge to change pressure within a smaller period of time than the period of time that causes the trailing edge to change pressure.

[0065] Fig.15F It is a drawing of the external auditory canal pressure achieved within a period of time relative to the ambient pressure, which represents a second constructed method of using the external auditory canal pressure regulating device, wherein operating the fluid flow generator by intermittent operation of the pressure relief element generates a pulsating external auditory canal pressure (less than the ambient pressure), and the pressure wave is a truncated wave in which the apex of the pressure wave has a constant pressure within a period of time.

[0066] Figure 15G is a plot of external auditory canal pressure achieved over a period of time relative to ambient pressure, which represents a second constructed method of using an external auditory canal pressure regulating device, wherein operating a fluid flow generator using intermittent operation of a pressure relief element generates a pulsating external auditory canal pressure (less than ambient pressure). DETAILED DESCRIPTION

[0067] Now the main reference Figure 1A and Figure 1B , illustrates a specific method of using an external auditory canal pressure regulating device 1 including one or more of the following components: a fluid flow generator 2, an earpiece 3 having an axial earpiece hole 4, and a valved conduit 5 fluidically coupled to the fluid flow generator 2 and the axial earpiece hole 4. The method of use may include: sealingly engaging an external auditory canal 6 with an earpiece outer surface 7 of the earpiece 3, generating a fluid flow 8 between the fluid flow generator 2 and the axial earpiece hole 4, and regulating a pressure difference 9 between an external auditory canal pressure 10 and an ambient pressure 11 to alleviate one or more symptoms of a condition or treat one or more conditions.

[0068] For purposes of the present invention, the term "pressure differential" means the difference in pressure between two locations.

[0069] For the purposes of the present invention, the term "pressure differential amplitude" means the value of the pressure difference between two locations. The pressure differential amplitude 59 can be expressed as an unsigned (positive or negative) number, regardless of whether the pressure at the first location is greater or less than the pressure at the second location. As an illustrative example, the external auditory canal pressure 10 is 1150 kPa above the ambient pressure and the external auditory canal pressure 10 is 1150 kPa below the ambient pressure can both have a pressure differential amplitude 59 of 50 kPa.

[0070] For the purposes of the present invention, the term "external auditory canal pressure" means the force applied within the external auditory canal 6, and without limitation to the aforementioned breadth, means the force applied within the external auditory canal 6 by a fluid volume 12, a preselected fluid volume 12, or a fluid flow 8 delivered to or generated in the external auditory canal 6 by operating the external auditory canal pressure regulating device 1.

[0071] For purposes of the present invention, as described herein, the term "ambient pressure" means the force applied from the outside to the external auditory canal 6 in the surrounding environment, and, without limitation to the foregoing breadth, means the force applied to the earpiece 3 having an earpiece outer surface 7 sealably engaged with the external auditory canal 6.

[0072] For the purposes of the present invention, the term "preselected" means a parameter such as a fluid volume 12 or a pressure difference amplitude 59 determined before administration, for example by a user 23 of the external auditory canal pressure regulating device 1, to be delivered to the external auditory canal 6, generated in the external auditory canal 6, or administered to the external auditory canal 6 by operating the external auditory canal pressure regulating device 1, and subsequently delivered to the external auditory canal 6, generated in the external auditory canal 6, or administered to the external auditory canal 6 by operating the external auditory canal pressure regulating device 1. For example, a preselected fluid volume 12 of 10 ml can be selected in advance to be delivered to the external auditory canal 6 by operating the external auditory canal pressure regulating device 1, and subsequently, a preselected fluid volume 12 of 10 ml can be delivered to the external auditory canal 6 by operating the external auditory canal pressure regulating device 1.

[0073] For the purposes of the present invention, the term "symptom" means any discomfort or combination of discomforts associated with a disorder. Without limiting the breadth of the foregoing, symptoms may include: dizziness; vertigo; nausea; imbalance; paresthesia; dysesthesia; sensitivity to light; sensitivity to smell; sensitivity to sound; anxiety; insomnia; irritability; fatigue; loss of appetite; blurred vision; intestinal disturbances; acute or chronic pain of varying characteristics, including but not limited to: throbbing, tearing, sharp, dull, deep, stabbing, burning, aching, stabbing, strong, sudden, feeling of swelling or tingling, etc.; or combinations thereof.

[0074] For the purposes of the present invention, the term "disorder" means a physical or mental condition that may be abnormal or unhealthy. Without limiting the breadth of the foregoing, the disorder may include: neuropathic craniofacial pain symptoms, such as neuralgia, for example, trigeminal neuralgia; temporomandibular joint symptoms; headache symptoms, such as migraine, chronic daily headache, cluster headache, muscle tension headache, post-traumatic headache, or chronic paroxysmal migraine; intralabyrinthal effusion; vertigo; tinnitus; symptoms caused by brain injury; symptoms caused by impaired neurological function, including cognitive disorders, such as attention deficit disorder, mood disorders such as anxiety disorders, or epilepsy; phantom limbs; middle ear disorders; inner ear disorders, etc., or combinations thereof.

[0075] Now the main reference Figure 2A and Figure 2B , the fluid flow generator 2 can have any of a variety of numerous configurations capable of generating a fluid flow 8 between the fluid flow generator 2 and the axial earpiece hole 4. As for a specific embodiment, the fluid flow generator 2 can include a volume adjustable element 13 capable of being adjusted between a larger volume and a smaller volume. As an illustrative example, adjusting the volume adjustable element 13 from a larger volume to a smaller volume can generate a fluid flow 8 away from the fluid flow generator 2, while adjusting the volume adjustable element 13 from a smaller volume to a larger volume can generate a fluid flow 8 toward the fluid flow generator 2.

[0076] As to a specific embodiment, the fluid flow generator 2 may include a bladder 14 or diaphragm 15 having a resiliently flexible wall 16 having an outer wall surface 17 and an inner wall surface 18. The outer wall surface 17 may be configured in any manner that allows the resiliently flexible wall 16 to deform (e.g., FIG. 11A to FIG. 12D and FIG. 13A to FIG. 13F ). The inner wall surface 18 may define an inner volume 19 (whether in whole or in part as a component of the valved conduit 5). Fig. 11B and Fig. 12B The elastically flexible wall 16 can reduce the internal volume 19 and return to the non-deformed state 21 (as shown in the example of Fig. 11C and Fig. 12C ) can increase the internal volume 19. The change in the internal volume 19 can generate a fluid flow 8 between the fluid flow generator 2 and the axial earpiece hole 4, and the fluid flow 8 can be regulated by the valved conduit 5. As for the specific embodiment, the airbag 14 or the diaphragm 15 can have an internal volume 19 in a non-deformed state 21, and when the internal volume 19 is completely reduced, it may not be enough to reach the deformed state 20 to generate the fluid flow 8 or the amount of pressure 22 that can cause discomfort to the user 23 of the external auditory canal pressure regulating device 1 or cause damage to the auditory canal 24 or the eardrum 25.

[0077] As for other specific embodiments, the fluid flow generator 2 may include a positive displacement pump 26, wherein a piston 27 is disposed in a cylinder 28 (eg, Figure 4C The piston 27 reciprocates in the cylinder 28 to adjust the internal volume of the cylinder between a smaller volume and a larger volume. The reciprocating movement of the piston 27 in the cylinder 28 can generate a fluid flow 8 between the fluid flow generator 2 and the axial earpiece hole 4, and the fluid flow 8 can be regulated by the valved conduit 5. As for the specific embodiment, the cylinder 28 can have a cylinder internal volume, and through the stroke of the piston 27 in the cylinder 28, when the internal volume of the cylinder is completely reduced, the internal volume of the cylinder may not be enough to generate the fluid flow 8 or the amount of pressure 22 that can cause discomfort to the user 23 of the external auditory canal pressure regulating device 1 or damage to the auditory canal 24 or the tympanic membrane 25.

[0078] The fluid flow generator 2 can be configured to generate a fluid flow 8 in a valved conduit 5 between the fluid flow generator 2 and the axial earpiece hole 4, whereby the fluid flow 8 can have a fluid volume 12 typically in a range between 0 ml and about 20 ml; however, depending on the application, embodiments can have a smaller or larger fluid volume 12. As to a specific embodiment, the fluid volume 12 can be a preselected fluid volume 12 that can be selected from one or more of the following group, the group including or consisting of: between 0 ml and about 2 ml, between about 1 ml and about 3 ml, between about 2 ml and about 4 ml, between about 3 ml and about 5 ml, between about 4 ml and about 6 ml, between about 5 ml and about 7 ml, between about 6 ml and about 8 ml, between about 7 ml and about 9 ml, between about 8 ml and about 10 ml, between about 9 ml and about 11 ml, between about 10 ml and about 12 ml, between about 11 ml and about 13 ml, between about 12 ml and about 14 ml, between about 13 ml and about 15 ml, between about 14 ml and about 16 ml, between about 15 ml and about 17 ml, between about 16 ml and about 18 ml, between about 17 ml and about 19 ml, and between about 18 ml and about 20 ml.

[0079] Depending on the method of use, one or more preselected fluid volumes 12 can be generated using the external auditory canal pressure regulating device 1, which may be further influenced by factors such as the anatomy of the user 23, the physiology or biochemistry of the auditory canal 24; the symptoms of the condition to be alleviated; the condition to be treated; the observable effects of using one or more preselected fluid volumes 12 in a specific method of using the external auditory canal pressure regulating device 1; or a combination thereof; but not so much as to cause discomfort to the user 23 or damage to the auditory canal 24 or tympanic membrane 25.

[0080] Again, the main reference Figure 2A and Figure 2B, the earpiece 3 can have a compliant earpiece outer surface 7 that is configured to be inserted into the external auditory canal 6 of the auditory canal 24, thereby acting as a barrier between the external auditory canal pressure 10 and the ambient pressure 11. Embodiments of the earpiece 3 can be configured to be sufficiently sealably engaged with the external auditory canal 6 to resist axial or lateral displacement due to normal anatomical changes in the external auditory canal 6 within a normal operating temperature range of about 20°C (about 68°F) to about 50°C (about 122°F), and to allow the generation and maintenance of a normal operating pressure range of about negative 50 kilopascals (–50 kPa) below the ambient pressure 11 to about positive 50 kilopascals (+50 kPa) above the ambient pressure 11.

[0081] The earpiece 3 of the external auditory canal pressure regulating device 1 can be formed of a compatible material that can be compressibly deformed when engaged with the external auditory canal 6, thereby allowing the earpiece 3 to sealably conform to the external auditory canal 6. As for these specific embodiments, the earpiece 3 can be formed, molded, three-dimensionally printed, or otherwise manufactured from any of a wide variety of materials that can sealably engage with the external auditory canal 6, including or consisting of the following: silicone resin, foam (including polyurethane foam), silicone oil II, low-hardness elastomer, etc., or a combination thereof.

[0082] As for specific embodiments, the earpiece 3 can be formed of a material (e.g., an elastomer of relatively low hardness). As for other specific embodiments, the earpiece 3 can be formed of multiple layers, such as an inner core layer with relatively high hardness surrounded by an outer layer with relatively low hardness, or an inner core layer with relatively low hardness surrounded by an outer layer with relatively high hardness. As for still other specific embodiments, the flexible earpiece wall can define the hollow inner space of the earpiece 3, whereby the flexible earpiece wall can be deformed to allow the earpiece outer surface 7 to sealably conform to the external auditory canal 6.

[0083] As for the specific embodiment, a portion of the outer surface 7 of the earpiece can be tapered inwardly near the second end 29 of the earpiece (eg, FIG. 4A to FIG. 4D As an illustrative example of a specific embodiment of this configuration, the earpiece outer surface 7 may be configured to be in the general form of a truncated cone that tapers inwardly toward the earpiece second end 29 (eg, FIG. 4E to FIG. 4G ).

[0084] The earpiece outer surface 7 may further include a plurality of circumferential ribs 30 disposed in a spaced relationship between the earpiece first end 31 and the earpiece second end 29. The plurality of circumferential ribs 30 may each extend from the earpiece outer surface 7 to a substantially uniform height; however, as for those embodiments of the earpiece outer surface 7 having a conical configuration, the plurality of circumferential ribs 30 may have a decreasing rib diameter 32 (e.g., ribs 32) approaching the earpiece second end 29. Figure 4HAs an illustrative example, the rib diameter 32 of the first circumferential rib 33 near the first end 31 of the earpiece can be approximately 7 mm, and the rib diameter 32 of the last circumferential rib 34 near the second end 29 of the earpiece can be approximately 4 mm, and the circumferential ribs 30 are arranged between the first circumferential rib 33 and the last circumferential rib 34, and the rib diameter 32 decreases from the first circumferential rib 33 to the last circumferential rib 34, respectively. However, the embodiment does not necessarily need to be so limited, and the plurality of circumferential ribs 30 can be configured in any of a variety of numerous configurations suitable for insertion into and sealably engaging the external auditory canal 6, thereby serving as a barrier between the external auditory canal pressure 10 and the ambient pressure 11.

[0085] The earpiece outer surface 7 may maintain sealable engagement with the external auditory canal 6 via friction between the earpiece outer surface 7 and the external auditory canal 6. As for specific embodiments, the earpiece outer surface 7 may maintain engagement with the external auditory canal 6 during normal operation by forcibly pushing onto the external auditory canal pressure regulating device 1. As for other specific embodiments, a restraining element coupled to the external auditory canal pressure regulating device 1 may be worn around the ear 35 or head 36 to assist in retaining the earpiece 3 in the external auditory canal 6.

[0086] Again, the main reference Figure 2A and Figure 2B , the earpiece 3 may have an axial earpiece hole 4 that communicates between the earpiece first end 31 and the earpiece second end 29. The axial earpiece hole 4 near the earpiece first end 31 may be fluidly coupled to the valved conduit 5 and configured to allow fluid flow 8 between the earpiece first end 31 and the earpiece second end 29.

[0087] Now the main reference Figure 5 and Figure 6 , the earpiece 3 may further include a tubular bolt 37 arranged around the axial earpiece hole 4. The tubular bolt 37 may be fully or partially connected between the earpiece first end 31 and the earpiece second end 29, providing a bolt hole 38 that is fully or partially connected between the earpiece first end 31 and the earpiece second end 29. For example, within a normal operating temperature range and a normal operating pressure range, the tubular bolt 37 may be sufficiently rigid to reduce or prevent deformation of the axial earpiece hole 4 when the earpiece outer surface 7 is sealably engaged with the external auditory canal 6, thereby maintaining sufficient fluid flow 8 in the axial earpiece hole 4 during the above-mentioned normal use.

[0088] The tubular bolt 37 may further include a bolt outer surface 39 having dimensions for removable insertion into the axial earpiece hole 4, such as to provide a sufficient fluid seal within a normal operating temperature range and a normal operating pressure range to maintain sufficient fluid flow 8 within the axial earpiece hole 4 during the above-mentioned normal use. As for a specific embodiment, the bolt outer surface 39 may further include a plurality of circumferential barbs spaced along the bolt outer surface 39 to assist in retaining the tubular bolt 37 within the axial earpiece hole 4 and providing a fluid seal.

[0089] As for embodiments including a discrete tubular bolt 37, the earpiece 3 and the tubular bolt 37 may be provided as a one-piece configuration with the earpiece 3 molded or formed around the tubular bolt 37. As for other embodiments, the earpiece 3 may be formed or molded to provide increased rigidity proximate the axial earpiece aperture 4. However, the embodiments need not be so limited, as any of a variety of numerous structures known to those of ordinary skill in the art may be utilized to provide a fluid-tight relationship between the tubular bolt 37 and the axial earpiece aperture 4.

[0090] Now the main reference Figures 7 to 10 , the external auditory canal pressure regulating device 1 may include a valved conduit 5, which is fluidically coupled to the fluid flow generator 2 and the axial earpiece hole 4. As for a specific embodiment, the valved conduit 5 may be included in a conduit body 41 having a structure that is removably coupled to the fluid flow generator 2 and the earpiece 3, whereby the fluid flow generator 2 and the earpiece 3 may be removably coupled to either the conduit body first end 42 or the conduit body second end 43. The releasable coupling surface 44 of the fluid flow generator 2, the releasable coupling surface 44 of the earpiece 3, the conduit body first end 42, and the conduit body second end 43 may have sufficiently similar structures (such as Figure 7 ), to allow the fluid flow generator 2 and the earpiece 3 to be releasably connected to either the first end 42 or the second end 43 of the conduit body, depending on whether the valved conduit 5 is operated to achieve a pressure difference 9 (such as a pressure difference 9 in which the external auditory canal pressure 10 is greater than the ambient pressure 11) caused by the external auditory canal pressure 10. Figure 5 ), or whether the valved conduit 5 is operated to achieve a pressure difference 9 (such as when the external auditory canal pressure 10 is less than the ambient pressure 11) Figure 6 ).

[0091] The releasable connection surface 44 of the fluid flow generator 2, the releasable connection surface 44 of the earpiece 3, the first end 42 of the conduit body, and the second end 43 of the conduit body can be matingly engaged. As an illustrative example, the releasable connection surface 44 can be constructed as a rotatably mating spiral. However, the embodiment does not necessarily need to be so limited, and can have a releasable connection surface 44 constructed in any of a variety of numerous ways to allow the conduit body 41 including the valved conduit 5 to be positioned in the first configuration 45 to operationally achieve a pressure difference 9 (such as causing the external auditory canal pressure 10 to have a pressure difference greater than the ambient pressure 11) . Figure 5 ), and further allows the pipeline body 41 including the valve pipeline 5 to be positioned in the second structure 46 to operationally achieve the pressure difference 9 (such as the pressure 10 of the external auditory canal having a pressure difference 9 less than the ambient pressure 11) Figure 6 ).

[0092] As an illustrative example, the conduit body 41 including the valved conduit 5 can be positioned in the first configuration 45 by removably coupling the conduit body first end 42 to the fluid flow generator 2 and removably coupling the conduit body second end 43 to the earpiece 3 (as shown in the example of FIG. 8 ). Thus, the fluid flow 8 can be regulated in the valved conduit 8 in a first direction 47 to operationally achieve a pressure difference 9 (as shown in the example of FIG. 8 ) that causes the external auditory canal pressure 10 to have a pressure difference 9 greater than the ambient pressure 11. Figure 5 ).

[0093] As for the specific embodiment, the fluid flow generator 2 can be removed from the pipe body first end 42, and the earpiece 3 can be removed from the pipe body second end 43 to disassemble the first configuration 45. The pipe body 41 can be rotated without any structural changes to reverse the orientation of the pipe body first end 42 and the pipe body second end 43 (such as Fig. 9 The valved pipe 5 can be connected to the receiver 3 by removably connecting the pipe body first end 42 and the fluid flow generator 2 by removably connecting the pipe body second end 43 (as shown in the example of FIG. Fig.10 As shown in the example of FIG. 4 , the fluid flow 8 can be adjusted in the second direction 48 in the valved conduit 5 to achieve a pressure difference 9 (such as the pressure difference 9 of the external auditory canal pressure 10 being less than the ambient pressure 11) in operation. Figure 6 ).

[0094] Now the main reference Figure 2A , Figure 2B , Figure 5 and Figure 6, the valved conduit 5 may include a first fluid flow conduit 49, which is connected between a first fluid flow conduit first end 50 and a first fluid flow conduit second end 51. As for the specific embodiment of the external auditory canal pressure regulating device 1 described herein, the first fluid flow conduit first end 50 is connected to the fluid flow generator 2, and the first fluid flow conduit second end 51 is connected to the axial earpiece hole 4 of the earpiece 3, regardless of whether the conduit body 41 is positioned in the first configuration 45 or the second configuration 46.

[0095] The first fluid flow conduit 49 can be interrupted by the first valve 52 to unidirectionally regulate the fluid flow 8 between the first fluid flow conduit first end 50 and the first fluid flow conduit second end 51 and correspondingly between the fluid flow generator 2 and the axial earpiece 4. In the above-mentioned first configuration 45, the fluid flow generator 2 can be sealably engaged with the first fluid flow conduit first end 50, and the axial earpiece 4 can be sealably engaged with the first fluid flow conduit second end 51 to unidirectionally regulate the fluid flow 8 in the first direction 47 from the fluid flow generator 2 toward the axial earpiece 4. Therefore, the external auditory canal pressure regulating device 1 sealably engaged with the external auditory canal 6 can be operatively realized to make the external auditory canal pressure 10 have a pressure difference 9 greater than the ambient pressure 11 by transmitting the fluid volume 12 from the fluid flow generator 2 to the external auditory canal 6. In the above-mentioned second configuration 46, the fluid flow generator 2 can be sealably engaged with the first end 50 of the first fluid flow conduit, and the axial earpiece hole 4 can be sealably engaged with the second end 51 of the first fluid flow conduit to unidirectionally regulate the fluid flow 8 in the second direction 48 from the axial earpiece hole 4 toward the fluid flow generator 2. Therefore, the external auditory canal pressure regulating device 1 sealably engaged with the external auditory canal 6 can be operated to achieve a pressure difference 9 that makes the external auditory canal pressure 10 less than the ambient pressure 11 by transferring the fluid volume 12 from the external auditory canal 6 to the fluid flow generator 2.

[0096] Again, the main reference Figure 2A , Figure 2B , Figure 5 and Figure 6, the first valve 52 can divide the first fluid flow conduit 49 into: a first portion 53 close to the first end 50 of the first fluid flow conduit and correspondingly close to the fluid flow generator 2; and a second portion 54 close to the second end 51 of the first fluid flow conduit and correspondingly close to the axial earpiece hole 4 of the earpiece 3. As for the specific embodiment, the valved conduit 5 can further include a second fluid flow conduit 55, which is fluidically connected between the first portion 53 of the first fluid flow conduit 49 and the ambient pressure 11. As for the specific embodiment of the external auditory canal pressure regulating device 1 described herein, the second fluid flow conduit 55 is fluidically connected to the first portion 53 of the first fluid flow conduit 49 close to the fluid flow generator 2, regardless of whether the conduit body 41 is positioned in the first configuration 45 or the second configuration 46. The second fluid flow conduit 55 can be interrupted by the second valve 56 to unidirectionally regulate the fluid flow 8 in the second fluid flow conduit 55.

[0097] Now the main reference Figure 2A and Figure 5 , as for the specific embodiment with the first configuration 45 of the fluid flow generator 2, the fluid flow generator 2 includes a volume adjustable element 13 having an internal volume 19 defined by an elastic flexible wall 16, and the deformed state 20 of the elastic flexible wall 16 can reduce the internal volume 19 to generate a fluid flow 8 in a first direction 47 in a first fluid flow conduit 49 from the fluid flow generator 2 toward the axial earpiece hole 4 of the earpiece 3, whereby the first valve 52 and the second valve 56 unidirectionally regulate the fluid flow 8 to be discharged from the axial earpiece hole 4. Therefore, the external auditory canal pressure regulating device 1 sealably engaged with the external auditory canal 6 can be operatively implemented to make the external auditory canal pressure 10 have a pressure difference 9 greater than the ambient pressure 11 by transmitting the fluid volume 12 from the fluid flow generator 2 to the external auditory canal 6.

[0098] The elastic flexible wall 16 of the volume adjustable element 13 can return to the non-deformed state 21, and the non-deformed state 21 can increase the internal volume 19 to generate a fluid flow 8 in the second fluid flow conduit 55, whereby the second valve 56 unidirectionally regulates the fluid flow 8 to enter the fluid flow generator 2 from the ambient pressure 11. The first valve 52 can interrupt the fluid flow 8 from the axial earpiece hole 4 toward the fluid flow generator 2 in the first fluid flow conduit 49. An embodiment of the external auditory canal pressure regulating device 1 sealably engaged with the external auditory canal 6 can maintain a pressure difference 9 in operation, wherein the external auditory canal pressure 10 can be maintained greater than the ambient pressure 11 and simultaneously transfer the fluid volume 12 from the ambient pressure 11 to the fluid flow generator 2 so that the elastic flexible wall 16 of the volume adjustable element 13 returns to the non-deformed state 21.

[0099] Now the main reference Figure 2B and Figure 6As for the specific embodiment of the second structure 46 having a fluid flow generator 2, the fluid flow generator 2 includes a volume adjustable element 13 having an internal volume 19 defined by an elastic flexible wall 16, and the deformation state 20 of the elastic flexible wall 16 can reduce the internal volume 19 to generate a fluid flow 8 from the fluid flow generator 2 toward the ambient pressure 11 in the second fluid flow conduit 55, thereby the first valve 52 and the second valve 56 unidirectionally regulate the fluid flow 8 to discharge from the second fluid flow conduit 55 to the ambient pressure 11.

[0100] The elastically flexible wall 16 of the volume adjustable element 13 can return to the non-deformed state 21, and the non-deformed state 21 can increase the internal volume 19 to generate a fluid flow 8 in the second direction 48 in the first fluid flow conduit 49, whereby the first valve 52 unidirectionally regulates the fluid flow 8 to enter the fluid flow generator 2 from the axial earpiece hole 4 of the earpiece 3. The second valve 56 can interrupt the fluid flow 8 from the ambient pressure 11 toward the fluid flow generator 2 in the second fluid flow conduit 55. Therefore, the external auditory canal pressure regulating device 1 sealably engaged with the external auditory canal 6 can operationally achieve and maintain a pressure difference 9, wherein the external auditory canal pressure 10 can be maintained less than the ambient pressure 11 and at the same time the fluid volume 12 is transmitted from the external auditory canal 6 to the fluid flow generator 2 so that the elastically flexible wall 16 of the volume adjustable element 13 returns to the non-deformed state 21.

[0101] Now the main reference Figure 2A , Figure 2B , Figure 5 and Figure 6 As for the specific embodiment, the valved conduit 5 may further include a third fluid flow conduit 57, which is fluidically connected between the second portion 54 of the first fluid flow conduit 49 and the ambient pressure 11. As for the specific embodiment of the external auditory canal pressure regulating device 1 described herein, the third fluid flow conduit 57 is fluidically connected to the second portion 54 of the first fluid flow conduit 49 close to the axial earpiece hole 4, regardless of whether the conduit body 41 is positioned in the first configuration 45 or in the second configuration 46.

[0102] The third fluid flow conduit 57 can be interrupted by a third valve 58 to unidirectionally regulate the fluid flow 8 in the third fluid flow conduit 57. As for specific embodiments, the third valve 58 can regulate the fluid flow 8 to be discharged from the third fluid flow conduit 57 to the ambient pressure 11. As for other specific embodiments, the third valve 58 can regulate the fluid flow 8 to enter the third fluid flow conduit 57 from the ambient pressure 11.

[0103] As to a specific embodiment, the third valve 58 can interrupt the flow of fluid 8 in the third fluid flow conduit 57 until the pressure differential 9 between the second portion 54 of the first fluid flow conduit 49 and the ambient pressure 11 exceeds a preselected pressure differential 9, the preselected pressure differential 9 having a pressure differential amplitude 59 that is typically in the range of between 0 kPa and about 50 kPa; however, depending on the application, embodiments can have a smaller or larger preselected pressure differential amplitude 59. As to a specific embodiment, the preselected pressure differential amplitude 59 can be selected from the group consisting of: between 0 kPa and about 5 kPa, between about 2.5 kPa and about 7.5 kPa, between about 5 kPa and about 10 kPa, between about 7.5 kPa and about 12.5 kPa, between about 10 kPa and about 15 kPa, between about 12.5 kPa and about 17.5 kPa, between about 15 kPa and about 20 kPa, between about 17.5 kPa and about 22.5 kPa, between about 20 kPa and about 25 kPa kPa to about 22.5 kPa to about 27.5 kPa, about 25 kPa to about 30 kPa, about 27.5 kPa to about 32.5 kPa, about 30 kPa to about 35 kPa, about 32.5 kPa to about 37.5 kPa, about 35 kPa to about 40 kPa, about 37.5 kPa to about 42.5 kPa, about 40 kPa to about 45 kPa, about 42.5 kPa to about 47.5 kPa, and about 45 kPa to about 50 kPa.

[0104] Depending on the method of use, one or more preselected pressure differential amplitudes 59 can be generated using the external auditory canal pressure regulating device 1, which may be further affected by factors such as the anatomy of the user 23, the physiology or biochemistry of the auditory canal 24; the symptoms of the condition to be alleviated; the condition to be treated; the observable effects of using one or more preselected pressure differential amplitudes 59 in a specific method of using the external auditory canal pressure regulating device 1; or a combination thereof; but not so much as to cause discomfort to the user 23 or damage to the auditory canal 24 or the tympanic membrane 25.

[0105] Now the main reference Figure 2A and Figure 2BThe valved pipeline 5 may include a fluid flow manifold 60, which may be interrupted by operating one or more valves 61 such as the first valve 52, the second valve 56, the third valve 58, or an additional valve 61 to correspondingly change the configuration of the manifold fluid flow path 62 within the fluid flow manifold 60, thereby regulating the fluid flow 8 within the fluid flow manifold 60. Although the figures schematically illustrate the specific configuration of the fluid flow manifold 60, which in turn defines the specific configuration of the manifold fluid flow path 62, the embodiments do not necessarily need to be so limited with respect to the configuration of the fluid flow manifold 60 or the manifold fluid flow path 62 of the valved conduit 5, and the embodiments may include any of a variety of numerous configurations that may fluidly connect the above-mentioned first fluid flow conduit 49, the second fluid flow conduit 55, and the third fluid flow conduit 57 (or additional fluid flow conduits), regardless of whether as multiple discrete conduits, a single-piece manifold, or defined by a conduit body 41, whether formed, molded, three-dimensionally printed, or otherwise manufactured as a single-piece configuration or by a first valve 52, a second valve 56, or a third valve 58 (or an additional valve 61) that may be arranged, assembled, or otherwise connected to generate a valved conduit 5 and is not limited to the aforementioned breadth of multiple piece assemblies, and may include FIG. 4A to FIG. 6 The illustrative example of FIG. 4 shows a configuration of the conduit body 41 that can be injection molded around as a one-piece conduit body 41 or can receive the first valve 52, the second valve 56, or the third valve 58 (or additional valves).

[0106] Now the main reference FIG. 3A to FIG. 3E ,exist Figure 2A and Figure 2B The first valve 52, the second valve 56 or the third valve 58 schematically illustrated in the figure can have any type of valve structure capable of regulating the fluid flow 8 described herein and is not limited to the aforementioned breadth, and can include a spring-loaded ball check valve 63 (such as Figure 3C ), a flapper valve 64 having a hinge 94 (such as Figure 3B ), a spring-loaded valve having a seat and a seatable and deformable circular lip 65 (such as Figure 3A ), umbrella valve 66 (as shown in the example of Figure 3D ), duckbill valve 67 (as shown in the example Figure 3E ) or other valves 61 that can be operated between a closed state 68 and an open state 69 to unidirectionally regulate the fluid flow 8 within a preselected range.

[0107] As for specific embodiments, the first valve 52, the second valve 56, or the third valve 58 can be operated between a closed state 68 and an open state 69, wherein the closed state 68 can be substantially leakproof for backward flow and substantially leakproof for forward fluid flow 8 at a pressure differential amplitude 59 of up to about 50 kPa on the opposite sides of the valve 61; the open state 69 can have a forward flow in the range of about 0.2 ml per second to about 20 ml per second. As for specific embodiments, the pressure differential 9 between the opposite sides of the valve 61 or the forward fluid flow 8 in the open state 69 of the valve 61 can be adjusted via the configuration of the valve 61, the unrestricted cross-sectional area of ​​the manifold fluid flow path 62, etc., or a combination thereof. In addition, although the disclosed examples of the external auditory canal pressure regulating device 1 can generate a pressure differential amplitude 59 of up to 50 kPa between the external auditory canal pressure 10 and the ambient pressure 11, these examples are not intended to teach or suggest that all embodiments of the external auditory canal pressure regulating device 1 must achieve such a pressure differential amplitude 59 between the external auditory canal pressure 10 and the ambient pressure 11. In contrast, specific embodiments of the external auditory canal pressure regulating device 1 can be configured to achieve a pressure differential 9 between the external auditory canal pressure 10 and the ambient pressure 11 based on effective relief of one or more symptoms of a condition such as neurologically mediated pain or treatment of one or more conditions such as craniofacial pain symptoms or headache symptoms.

[0108] Now the main reference Figure 5 , Figure 6 as well as FIG. 11A to FIG. 12D As for a specific embodiment, the valve 61 can be operably connected to a pressure relief element 70, which is configured to allow the valve 61 to be manually operated between a closed state 68 and an open state 69. As an illustrative example, the pressure relief element 70 can be operable to allow the external auditory canal pressure 10 to return to the ambient pressure 11, regardless of whether the external auditory canal pressure 10 is greater than the ambient pressure 11 or the external auditory canal pressure 10 is less than the ambient pressure 11. As for a specific embodiment, the pressure relief element 70 can be operable to allow the fluid volume 12 to be discharged from a portion of the valved conduit 5 to the ambient pressure 11 or from the ambient pressure 11 to enter a portion of the valved conduit 5 when a preselected threshold external auditory canal pressure 10 is reached or exceeded, thereby reducing the risk of discomfort to the user 23 or damage to the auditory canal 24 or the tympanic membrane 25.

[0109] As for specific embodiments, the pressure relief element 70 can be configured to extend outwardly from the conduit body 41 a sufficient distance to allow the user 23 to engage the gripping engagement. As for other specific embodiments, the pressure relief element 70 can be configured as a resiliently flexible portion of the conduit body 41 that can flex when pressed together to place the valve 61 in the open state 69. When the pressure relief element 70 is disengaged, the valve 61 can return to the closed state 68.

[0110] Again, the main reference Figure 5 , Figure 6 and FIG. 11A to FIG. 12D As for the specific embodiment, the second valve pressure relief element 71 can be coupled to the second valve 56, and the third valve pressure relief element 72 can be coupled to the third valve 58. The second valve pressure relief element 71 and the third valve pressure relief element 72 can each be manually operable to generate the fluid flow 8 in the second fluid flow conduit 55 and the third fluid flow conduit 57, respectively.

[0111] Now the main reference FIG. 11A to FIG. 12D As for a specific embodiment, the external auditory canal pressure regulating device 1 can be configured to achieve an external auditory canal pressure 10 that can be less than or greater than the ambient pressure 11. The effective amount of external auditory canal pressure 10 for alleviating one or more symptoms of a condition or treating one or more conditions, or the maximum amount of external auditory canal pressure 10 achieved in the pressure regulation profile 73 generated by an embodiment of the external auditory canal pressure regulating device 1, can have a range from just above or just below the ambient pressure 11 to just above or below the external auditory canal pressure 10, at which pressure the user 23 may experience discomfort, or the auditory canal 24 or the tympanic membrane 25 may be damaged. Although the authority of the external auditory canal pressure 10 that may cause discomfort to the user 23 or damage to the auditory canal 24 or the tympanic membrane 25 varies, generally, embodiments of the external auditory canal pressure regulating device 1 will not be configured to operate beyond the following pressures: about -50 kPa below the ambient pressure 11 or about +50 kPa above the ambient pressure 11.

[0112] Now the main reference Figure 2A , Figure 5 as well as FIG. 11A to FIG. 11D As for a specific embodiment, the external auditory canal pressure regulating device 1 can be configured to achieve an external auditory canal pressure 10 that may be greater than the ambient pressure 11. Therefore, the valved conduit 5 can be coupled to the fluid flow generator 2 and the axial earpiece hole 4 of the earpiece 3 in a first configuration 45 to unidirectionally regulate the fluid flow 8 in the first fluid flow conduit 5 in a first direction 47, thereby discharging from the axial earpiece hole 4 to the external auditory canal 6.

[0113] like Fig.11A and Fig. 11BAs shown, the earpiece outer surface 7 of the earpiece 3 can be sealably engaged with the external auditory canal 6 described above. Operating the fluid flow generator 2 can compress the amount of fluid 74 in the first portion 53 of the first fluid flow conduit 49. As for those embodiments including the adjustable volume element 13, the elastically flexible wall 16 can be deformed to reduce the internal volume 19 of the adjustable volume element 13 to compress the amount of fluid 74 in the first portion 53 of the first fluid flow conduit 49, resulting in a pressure differential 9 between the opposite sides of the first valve 52 and the second valve 56. As for those embodiments including the piston 27 that reciprocates in the barrel 28, the piston 27 can travel within the barrel 28 to reduce the internal volume of the barrel, thereby resulting in a pressure differential 9 between the opposite sides of the first valve 52 and the second valve 56. Regardless of the configuration of the fluid flow generator 2, the pressure differential 9 between the opposite sides of the first valve 52 can cause the fluid pressure 75 in the first portion 53 of the first fluid flow conduit 49 to be greater than the fluid pressure 75 in the second portion 54 of the first fluid flow conduit 49. The pressure differential 9 may be sufficient to generate an open state 69 of the first valve 52. The pressure differential 9 between the opposite sides of the second valve 56 may be such that the fluid pressure 75 in the first portion 53 of the first fluid flow conduit 49 may be greater than the ambient pressure 11, which may be sufficient to generate a closed state 68 of the second valve 56. The open state 69 of the first valve 52 and the closed state 68 of the second valve 56 may result in a fluid flow 8 in the first direction 47 in the first fluid flow conduit 49, the fluid flow 8 flowing from the fluid flow generator 2 through the axial earpiece aperture 4 to discharge into the external auditory canal 6 from the earpiece second end 29, thereby increasing the external auditory canal pressure 10 to be greater than the ambient pressure 11.

[0114] like Fig. 11C As shown, continued operation of the fluid flow generator 2 may further act to reduce the pressure differential 9 between the opposite sides of the first valve 52 and the second valve 56, for example, by allowing the elastically flexible wall 16 of the adjustable volume element 13 to return to the non-deformed state 21. The pressure differential 9 between the opposite sides of the first valve 52 may be such that the fluid pressure 75 in the first portion 53 of the first fluid flow conduit 49 may be less than the fluid pressure 75 in the second portion 54 of the first fluid flow conduit 49. The pressure differential 9 may be sufficient to generate a closed state 68 of the first valve 52, thereby interrupting the fluid flow 8 in the first fluid flow conduit 49 from the axial earpiece hole 4 toward the fluid flow generator 2, thereby maintaining the pressure differential 9 between the external auditory canal pressure 10 and the ambient pressure 11 accordingly.

[0115] Refer again Fig. 11C, continuing to reduce the fluid pressure 75 within the first portion 53 of the first fluid flow conduit 49 can result in a pressure differential 9 between opposite sides of the second valve 56, such that the fluid pressure 75 in the first portion 53 of the first fluid flow conduit 49 can be less than the ambient pressure 11, which may be sufficient to generate an open state 69 of the second valve 56. Therefore, a fluid flow 8 can be generated from the ambient pressure 11 toward the fluid flow generator 2 via the second fluid flow conduit 55. As for those embodiments having a volume adjustable element 13, the fluid flow 8 from the ambient pressure 11 toward the fluid flow generator 2 can allow the resiliently flexible wall 16 to return to the non-deformed state 21 by increasing the internal volume 19. As for those embodiments having a piston 27 reciprocating in the barrel 28, the fluid flow 8 from the ambient pressure 11 toward the fluid flow generator 2 via the second fluid flow conduit 55 can allow the piston 27 to return to a position within the barrel 28, which increases the internal volume of the barrel.

[0116] Now refer to Fig.11D , the third valve 58 in the closed state 68 can maintain a substantially leak-proof state for the fluid flow 8 in the third fluid flow conduit 57 at a pressure difference amplitude 59 of up to about 50 kPa between the external auditory canal pressure 10 and the ambient pressure 11. Therefore, the external auditory canal pressure regulating device 1 can be operated to achieve a desired external auditory canal pressure 10 greater than the ambient pressure 11, or to achieve a preselected external auditory canal pressure 10 greater than the ambient pressure 11, exceeding which pressure will result in an open state 69 of the third valve 58, allowing a fluid flow 8 from the external auditory canal pressure 10 toward the ambient pressure 11 to maintain the desired or preselected external auditory canal pressure 10.

[0117] Now the main reference Figure 5 and Fig.11D The third valve 58 can be operably connected to a third valve pressure relief element 72, and the third valve pressure relief element 72 is configured to allow manual operation of the third valve 58 between a closed state 68 and an open state 69 to facilitate the restoration of the external auditory canal pressure 10 to the ambient pressure 11.

[0118] Now the main reference Figure 2B , Figure 6 as well as FIG. 12A to FIG. 12D As for a specific embodiment, the external auditory canal pressure regulating device 1 can be configured to achieve an external auditory canal pressure 10 that may be less than the ambient pressure 11. Therefore, the valved conduit 5 can be coupled to the fluid flow generator 2 and the axial earpiece hole 4 of the earpiece 3 in the second configuration 46 to unidirectionally regulate the fluid flow 8 in the first fluid flow conduit 49 in the second direction 48, thereby entering the axial earpiece hole 4 from the external auditory canal 6 toward the fluid flow generator 2.

[0119] like Fig. 12A and Fig. 12BAs shown, the earpiece outer surface 7 of the earpiece 3 can be sealably engaged with the external auditory canal 6 described above. Operating the fluid flow generator 2 can compress the amount of fluid 74 in the first portion 53 of the first fluid flow conduit 49. As for those embodiments including the adjustable volume element 13, the elastically flexible wall 16 can be deformed to reduce the internal volume 19 of the adjustable volume element 13 to compress the amount of fluid 74 in the first portion 53 of the first fluid flow conduit 49, resulting in a pressure differential 9 between the opposite sides of the first valve 52 and the second valve 56. As for those embodiments including the piston 27 that reciprocates in the barrel 28, the piston 27 can travel within the barrel 28 to reduce the internal volume of the barrel, thereby resulting in a pressure differential 9 between the opposite sides of the first valve 52 and the second valve 56. Regardless of the configuration of the fluid flow generator 2, the pressure differential 9 between the opposite sides of the first valve 52 can cause the fluid pressure 75 in the first portion 53 of the first fluid flow conduit 49 to be greater than the fluid pressure 75 in the second portion 54 of the first fluid flow conduit 49. This pressure differential 9 may be sufficient to generate a closed state 68 of the first valve 52. The pressure differential 9 between the opposite sides of the second valve 56 may be such that the fluid pressure 75 in the first portion 53 of the first fluid flow conduit 49 may be greater than the ambient pressure 11, which may be sufficient to generate an open state 69 of the second valve 56, which may generate a fluid flow 8 in the second fluid flow conduit 55 from the fluid flow generator 2 toward the ambient pressure 11.

[0120] like Fig. 12C As shown, continued operation of the fluid flow generator 2 may further act to reduce the pressure differential 9 between the opposite sides of the first valve 52 and the second valve 56, for example, by allowing the resiliently flexible wall 16 of the adjustable volume element 13 to return to the non-deformed state 21. The pressure differential 9 between the opposite sides of the first valve 52 may be such that the fluid pressure 75 in the first portion 53 of the first fluid flow conduit 49 may be less than the fluid pressure 75 in the second portion 54 of the first fluid flow conduit 49. The pressure differential 9 may be sufficient to generate an open state 69 of the first valve 52, which may result in a fluid flow 8 from the external auditory canal 6 toward the fluid flow generator 2, thereby reducing the external auditory canal pressure 10 to be less than the ambient pressure 11.

[0121] Refer again Fig. 12C , continuing to reduce the fluid pressure 75 within the first portion 53 of the first fluid flow conduit 49 can cause a pressure differential 9 to exist between opposite sides of the second valve 56, so that the fluid pressure 75 in the first portion 53 of the first fluid flow conduit 49 can be less than the ambient pressure 11, which may be sufficient to generate a closed state 68 of the second valve 56, thereby interrupting the fluid flow 8 in the second fluid flow conduit 55 from the fluid flow generator 2 toward the ambient pressure 11, and correspondingly maintaining the pressure differential 9 between the external auditory canal pressure 10 and the ambient pressure 11.

[0122] As for those embodiments with the volume adjustable element 13, the fluid flow 8 from the external auditory canal 6 toward the fluid flow generator 2 can allow the resiliently flexible wall 16 to return to the non-deformed state 21 by increasing the internal volume 19. As for those embodiments with the piston 27 reciprocating in the barrel 28, the fluid flow 8 from the external auditory canal 6 toward the fluid flow generator 2 via the first fluid flow conduit 49 can allow the piston 27 to return to a position within the barrel 28, which increases the internal volume of the barrel.

[0123] Now refer to Fig.12D , the third valve 58 in the closed state 68 can maintain a substantially leak-proof state for the fluid flow 8 in the third fluid flow conduit 57 when the pressure difference amplitude 59 between the external auditory canal pressure 10 and the ambient pressure 11 is up to about 50 kPa. Therefore, the external auditory canal pressure regulation device 1 can be operated to achieve a desired external auditory canal pressure 10 that is less than the ambient pressure 11, or to achieve a preselected external auditory canal pressure 10 that is less than the ambient pressure 11, exceeding which pressure will result in an open state 69 of the third valve 58, allowing a fluid flow 8 from the ambient pressure 11 toward the external auditory canal 6 to maintain the desired or preselected external auditory canal pressure 10.

[0124] Now the main reference Figure 6 and Fig.12D The third valve 58 can be operably connected to a third valve pressure relief element 72, and the third valve pressure relief element 72 is configured to allow manual operation of the third valve 58 between a closed state 68 and an open state 69 to facilitate the restoration of the external auditory canal pressure 10 to the ambient pressure 11.

[0125] Now the main reference FIG. 13A to FIG. 13F , a specific embodiment of the external auditory canal pressure regulating device 1 may include a fluid flow generator 2 configured as a diaphragm 15, which has an elastic flexible wall 16, and the elastic flexible wall 16 has a wall outer surface 17 and a wall inner surface 18 that define an internal volume 19 (whether in whole or in part as a component with a valved conduit 5). The elastic flexible wall 16 in a deformed state 20 can reduce the internal volume 19, and toward a non-deformed state 21, can increase the internal volume 19. The change in the internal volume 19 can generate a fluid flow 8 between the fluid flow generator 2 and the axial earpiece hole 4 of the earpiece 3 that can be regulated by the valved conduit 5.

[0126] Again, the main reference FIG. 13A to FIG. 13F, the external auditory canal pressure regulating device 1 may include a valved conduit 5, which is fluidically connected between the fluid flow generator 2 and the axial earpiece hole 4. As for a specific embodiment, the earpiece 3 having the axial earpiece hole 4 and the first fluid flow conduit 49, the second fluid flow conduit 55 and the third fluid flow conduit 57 may be included in a conduit body 41, and the conduit body 41 has a structure that is detachably connected to the fluid flow generator 2 and the first valve 52, the second valve 56 and the third valve 58. As for a specific embodiment, the first valve 52 and the second valve 56 may be included in a first valve assembly 83, and the first valve assembly 83 may be fluidically connected between the fluid flow generator 2 and the first fluid flow conduit 49 and the second fluid flow conduit 55 to interrupt the fluid flow 8 between the fluid flow generator 2 and the first fluid flow conduit 49 and the second fluid flow conduit 55, thereby unidirectionally regulating the fluid flow 8 in the first fluid flow conduit 49 and the second fluid flow conduit 55.

[0127] The third valve 58 may be included in the second valve assembly 84, which may be fluidically coupled to the third fluid flow conduit 57 communicating between the first fluid flow conduit 49 and the ambient pressure 11 to interrupt the fluid flow 8 between the third fluid flow conduit 57 and the ambient pressure 11, thereby unidirectionally regulating the fluid flow 8 in the third fluid flow conduit 57 between the first fluid flow conduit 49 and the ambient pressure 11. As for specific embodiments, the fluid flow generator 2 and the first valve assembly 83 and the second valve assembly 84 may be provided as a single-piece configuration. As for other specific embodiments, the fluid flow generator 2, the first valve assembly 83 and the second valve assembly 84 may be provided as a plurality of pieces that may be assembled into a configuration that may be removably coupled to the conduit body 41.

[0128] As for specific embodiments, the first valve 52 and the second valve 56 included in the first valve assembly 83 can have any type of valve configuration described above, which can be operated between a closed state 68 and an open state 69 to unidirectionally regulate the fluid flow 8 within a preselected range. As an illustrative example, the first valve 52 and the second valve 56 included in the first valve assembly 83 can both be configured as a flapper valve 64 (such as a hinge 94 having an opposing configuration) having a hinge 94 (such as a hinge 94 having an opposing configuration) Figure 3B as well as FIG. 13C to FIG. 13F ).

[0129] As for a specific embodiment, the second valve assembly 84 can be operated to allow the external auditory canal pressure 10 to return to the ambient pressure 11. The second valve assembly 84 can include an elastically deformable annular member 85 and a pressure relief element 70, and the pressure relief element 70 is configured as a deforming member 86 capable of deforming the elastically deformable annular member 85. The elastically deformable annular member 85 can have an annular member outer surface 87, and the annular member outer surface 87 can be arranged to be adjacent to and sealably engaged with the conduit inner surface 88 of the first fluid flow conduit 49.

[0130] The annular member hole element 89 communicating between the annular member inner surface 90 and the annular member outer surface 87 can be aligned with the axial earpiece hole 4 to form a straight piece 91 between the first fluid flow conduit 49 and the axial earpiece hole 4. The deforming member 86 can be arranged to pass through the third fluid flow conduit 57 communicating between the first fluid flow conduit 49 and the ambient pressure 11, so that the deforming member first end 92 can extend outward from the third fluid flow conduit 57 and the conduit body 41, and the deforming member second end 93 can deformably engage the annular member outer surface 87. When grasping and engaging the deforming member first end 92, the deforming member 86 can be pushed toward the elastically deformable annular member 85 to deform the elastically deformable annular member 85 so that the annular member outer surface 87 disengages from the conduit inner surface 88 of the first fluid flow conduit 49, thereby positioning the third valve 58 in the open state 69 to allow the fluid flow 8 to flow between the axial earpiece hole 4, the first fluid flow conduit 49 and the third fluid flow conduit 57 and the ambient pressure 11. Therefore, the third valve 58 in the open state 69 can generate a fluid flow 8 between the external auditory canal 6 and the ambient pressure 11 to restore the external auditory canal pressure 10 to the ambient pressure 11, regardless of whether the external auditory canal pressure 10 is greater than the ambient pressure 11 or the external auditory canal pressure 10 is less than the ambient pressure 11.

[0131] The fluid flow generator 2, the first valve assembly 83, and the second valve assembly 84 can be removably coupled to the conduit body 41 in either the first configuration 45 or the second configuration 46. The releasable coupling surface 44 of the conduit body 41, the fluid flow generator 2, the first valve assembly 83, and the second valve assembly 84 can have sufficiently similar configurations to allow the conduit body 41 to be removably coupled to the fluid flow generator 2, the first valve assembly 83, and the second valve assembly 84 in either the first configuration 45 or the second configuration 46, depending on whether the valved conduit 5 is operated to achieve a pressure difference 9 (such as causing the external auditory canal pressure 10 to have a pressure difference greater than the ambient pressure 11) . Fig.13E ) or whether the valved conduit 5 is operated to achieve a pressure difference 9 (such as Fig.13FAs for the specific embodiment, in order to be connected in a removable manner, the releasable connection surface 44 of the pipeline body 41, the fluid flow generator 2, the first valve assembly 83 and the second valve assembly 84 can be cooperatively engaged.

[0132] As for the specific embodiment of the external auditory canal pressure regulating device 1 described in this article, the first valve 52 and the second valve 56 are fluidically connected to the corresponding first fluid flow pipe 49 and the second fluid flow pipe 55 to interrupt the fluid flow 8 within the corresponding first fluid flow pipe 49 and the second fluid flow pipe 55, regardless of whether the pipe body 41 may be positioned in the first structure 45 or the second structure 46.

[0133] Now the main reference Fig.13E As an illustrative example, the fluid flow generator 2, the first valve assembly 83 and the conduit body 41 can be positioned in the first configuration 45 by removably coupling the fluid flow generator 2 and the first valve assembly 83 to the conduit body 41. In the first configuration 45, the first valve 52 can be operated to unidirectionally regulate the fluid flow 8 in the first fluid flow conduit 49, whereby the first valve 52 in the open state 69 allows the fluid flow 8 to flow from the fluid flow generator 2 to the axial earpiece hole 4, and blocks the fluid flow 8 from flowing between the fluid flow generator 2 and the axial earpiece hole 4 in the closed state 68. Therefore, in order to reduce the internal volume 19, the fluid flow 8 generated by deforming the elastically flexible wall 16 of the diaphragm 15 can be regulated in the first direction 47 in the first fluid flow conduit 49 to be discharged from the axial earpiece hole 4 to the external auditory canal 6, thereby achieving a pressure difference 9 in the external auditory canal pressure 10 greater than the ambient pressure 11. When the desired pressure difference 9 between the external auditory canal pressure 10 and the ambient pressure 11 is achieved, the elastic flexible wall 16 of the diaphragm 15 can be allowed to return to the non-deformed state 21, thereby closing the first valve 52 and preventing the fluid flow 8 from flowing from the axial earpiece hole 4 to the fluid flow generator 2, thereby maintaining the desired pressure difference 9.

[0134] In the first construction 45, the second valve 56 can be operated to unidirectionally regulate the fluid flow 8 in the second fluid flow conduit 55, whereby the second valve 56 in the open state 69 allows the fluid flow 8 to flow from the ambient pressure 11 to the fluid flow generator 2, and in the closed state 68 prevents the fluid flow 8 from flowing between the ambient pressure 11 and the fluid flow generator 2.

[0135] Therefore, in order to increase the internal volume 19, the fluid flow 8 generated when the elastic flexible wall 16 of the diaphragm 15 is returned to the non-deformed state 21 can be adjusted in the second fluid flow conduit 55 to enter the fluid flow generator 2 from the ambient pressure 11, thereby maintaining the desired pressure difference 9 between the external auditory canal pressure 10 and the ambient pressure 11, while allowing the elastic flexible wall 16 of the diaphragm 15 to return to the non-deformed state 21.

[0136] As for the specific embodiment, the fluid flow generator 2, the first valve assembly 83 and the duct body 41 in the first configuration 45 may further include a second valve assembly 84, which is positioned so that the third valve 58 can be fluidically coupled to the third fluid flow duct 57 communicating between the first fluid flow duct 49 and the ambient pressure 11 to unidirectionally regulate the fluid flow 8 in the third fluid flow duct 57 between the first fluid flow duct 49 and the ambient pressure 11. The third valve 58 in the open state 69 allows the fluid flow 8 to flow from the axial earpiece hole 4 through the first fluid flow duct 49 and the third fluid flow duct 57 and to the ambient pressure 11, and blocks the fluid flow 8 from flowing between the axial earpiece hole 4 and the ambient pressure 11 in the closed state 68. Therefore, the third valve 58 in the open state 69 can generate the fluid flow 8 from the external auditory canal 6 toward the ambient pressure 11 to restore the external auditory canal pressure 10 to the ambient pressure 11.

[0137] As for the specific embodiment, the fluid flow generator 2, the first valve assembly 83 and the second valve assembly 84 can be removed from the pipe body 41 to disassemble the first configuration 45. The first valve assembly 83 can be rotated without any structural changes to reverse the orientation of the first valve assembly 83 relative to the pipe body 41 to achieve the second configuration 46.

[0138] Now the main reference Fig.13F As an illustrative example, the fluid flow generator 2, the first valve assembly 83 and the conduit body 41 can be positioned in the second configuration 46 described above. In the second configuration 46, the second valve 56 can be operated to unidirectionally regulate the fluid flow 8 in the second fluid flow conduit 55, whereby the second valve 56 in the open state 69 allows the fluid flow 8 to flow from the fluid flow generator 2 to the ambient pressure 11, and in the closed state 68 prevents the fluid flow 8 from flowing between the fluid flow generator 2 and the ambient pressure 11. Therefore, to reduce the internal volume 19, the fluid flow 8 generated by deforming the elastically flexible wall 16 of the diaphragm 15 can be regulated in the second fluid flow conduit 55 to discharge from the second fluid flow conduit 55 to the ambient pressure 11. The elastically flexible wall 16 of the diaphragm 15 can be allowed to return to the non-deformed state 21, thereby closing the second valve 56 and preventing the fluid flow 8 from flowing between the fluid flow generator 2 and the ambient pressure 11.

[0139] In the second construction 46, the first valve 52 can be operated to unidirectionally regulate the fluid flow 8 in the first fluid flow conduit 49, whereby the first valve 52 in the open state 69 allows the fluid flow 8 to flow from the axial earpiece hole 4 to the fluid flow generator 2, and in the closed state 68 prevents the fluid flow 8 from flowing between the axial earpiece hole 4 and the fluid flow generator 2.

[0140] Therefore, in order to increase the internal volume 19, the fluid flow 8 generated when the elastic flexible wall 16 of the diaphragm 15 is returned to the non-deformed state 21 can be adjusted in the first fluid flow conduit 56 in the second direction 48 to enter the axial earpiece hole 4 from the external auditory canal 6 toward the fluid flow generator 2, thereby achieving a pressure difference 9 in the external auditory canal pressure 10 that is less than the ambient pressure 11. When the desired pressure difference 9 between the external auditory canal pressure 10 and the ambient pressure 11 is achieved, the first valve 52 can return to the closed state 68 to prevent the fluid flow 8 from flowing between the axial earpiece hole 4 and the fluid flow generator 2, thereby maintaining the desired pressure difference 9 between the external auditory canal pressure 10 and the ambient pressure 11.

[0141] As for the specific embodiment, the fluid flow generator 2, the first valve assembly 83 and the conduit body 41 in the second configuration 46 may further include a second valve assembly 84, which is positioned so that the third valve 58 can be fluidically coupled to the third fluid flow conduit 57 communicating between the first fluid flow conduit 49 and the ambient pressure 11 to unidirectionally regulate the fluid flow 8 in the third fluid flow conduit 57 between the first fluid flow conduit 49 and the ambient pressure 11. The third valve 58 in the open state 69 allows the fluid flow 8 to flow from the ambient pressure 11 through the third fluid flow conduit 57 and the first fluid flow conduit 49 and to the axial earpiece hole 4, and blocks the fluid flow 8 from flowing between the ambient pressure 11 and the axial earpiece hole 4 in the closed state 68. Therefore, the third valve 58 in the open state 69 can generate the fluid flow 8 from the ambient pressure 11 toward the external auditory canal 6 to restore the external auditory canal pressure 10 to the ambient pressure 11.

[0142] Now the main reference FIG. 14A to FIG. 15G , which shows the pressure difference 9 between the external auditory canal pressure 10 and the ambient pressure 11 achieved during a time period 76 by operating an embodiment of the external auditory canal pressure regulating device 1. As for a specific embodiment, the fluid flow generator 2 including the volume adjustable element 13 can be operated from the non-deformed state 21 toward the deformed state 20 to generate a fluid flow 8 along a first direction 47, and the fluid flow 8 is discharged from the axial earpiece hole 4 to the external auditory canal 6 during the time period 76, resulting in a positive external auditory canal pressure 10 relative to the ambient pressure 11 (such as FIG. 14A to FIG. 14G As for other specific embodiments, the fluid flow generator 2 including the volume adjustable element 13 can be operated from the deformed state 20 toward the non-deformed state 21 to generate a fluid flow 8 along the second direction 48, and the fluid flow 8 enters the axial earpiece hole 4 from the external auditory canal 6 toward the fluid flow generator 2 during the time period 76, resulting in a negative external auditory canal pressure 10 relative to the ambient pressure 11 (such as FIG. 15A to FIG. 15G ).

[0143] Now the main reference FIG. 14A to FIG. 15A, the fluid flow generator 2 can be operated to maintain a constant pressure amplitude 77 during a time period 76. As for a specific embodiment, the constant pressure amplitude 77 can be maintained during the time period 76 so that there is substantially no fluid flow 8 of the fluid volume 12 in the external auditory canal 6. As an illustrative example, the external auditory canal pressure regulating device 1 having the above-mentioned earpiece outer surface 7 sealably engaged with the external auditory canal 6 can be operated by manipulating the fluid flow generator 2 to generate a fluid flow 8 of the fluid volume 12 between the fluid flow generator 2 and the external auditory canal 6 via the axial earpiece hole 4 of the earpiece 3, thereby achieving a pressure difference 9 between the external auditory canal pressure 10 and the ambient pressure 11. Once the desired pressure difference 9 between the external auditory canal pressure 10 and the ambient pressure 11 is achieved, the pressure amplitude 77 can be maintained during the time period 76 without an additional fluid flow 8 of the fluid volume 12, for example by operating the first valve 52, the first valve 52 being configured to allow a unidirectional fluid flow 8 of the fluid volume 12 through the first fluid flow conduit 49, so that the fluid volume 12 can only enter or exit from the external auditory canal 6. As for other embodiments, once the desired pressure differential 9 between the external auditory canal pressure 10 and the ambient pressure 11 is achieved, the pressure amplitude 77 can be maintained during the period 76 by an additional fluid flow 8 of the fluid volume 12 into or out of the external auditory canal 6 to offset leakage about the junction of the earpiece outer surface 7 and the external auditory canal 6. As for other embodiments, the pressure amplitude 77 can be maintained during the period 76 by a continuous fluid flow 8 of the fluid volume 12 in the external auditory canal 6.

[0144] A constant pressure amplitude 77 may be maintained during the time period 76 to alleviate symptoms of a condition or to treat a condition, whereby the constant pressure amplitude 77 may be in a range between about +50 kPa above the ambient pressure 11 to about -50 kPa below the ambient pressure 11. A positive external auditory canal pressure 10 relative to the ambient pressure 11 may be achieved by maintaining the constant pressure amplitude 77 in a range between about 0 kPa to about +50 kPa above the ambient pressure 11. Alternatively, a negative external auditory canal pressure 10 relative to the ambient pressure 11 may be achieved by maintaining the constant pressure amplitude 77 in a range between about -50 kPa to about 0 kPa below the ambient pressure 11.

[0145] Now the main reference FIG. 14B to FIG. 14G as well as FIG. 15B to FIG. 15G , the fluid flow generator 2 can be configured to operate repeatedly to generate a fluid flow 8 having a pressure wave 78 including a pressure wave amplitude 77 and a pressure wave frequency 79. As for a specific embodiment, the fluid flow generator 2 including the volume adjustable element 13 can be operated from the non-deformed state 21 toward the deformed state 20 to generate a fluid flow 8 discharged from the axial earpiece hole 4 to the external auditory canal 6 within a time period 76, whereby the fluid flow 8 has a pressure wave 78 including a pressure wave amplitude 77 and a pressure wave frequency 79, which results in a positive external auditory canal pressure 10 relative to the ambient pressure 11 (such as FIG. 14B to FIG. 14GAs for other specific embodiments, the fluid flow generator 2 including the volume adjustable element 13 can be operated from the deformed state 20 toward the non-deformed state 21 to generate a fluid flow 8 from the external auditory canal 6 to the axial earpiece hole 4 toward the fluid flow generator 2 within a time period 76, whereby the fluid flow 8 has a pressure wave 78 including a pressure wave amplitude 77 and a pressure wave frequency 79, which results in a negative external auditory canal pressure 10 relative to the ambient pressure 11 (such as FIG. 15B to FIG. 15G ).

[0146] Again, the main reference FIG. 14A to FIG. 15G , the fluid flow generator 2 can be configured to operate repeatedly to generate a fluid flow 8 having a pressure wave 78, the pressure wave 78 including the above-mentioned pressure wave amplitude 77 and a pressure wave frequency 79 typically in a range between 0 Hz and about 10 Hz; however, depending on the application, the embodiment can have a smaller or larger pressure wave frequency 79. As to specific embodiments, one or more pressure wave frequencies 79 can be selected from the group consisting of: between 0 Hz and about 1 Hz, between about 0.5 Hz and about 1.5 Hz, between about 1 Hz and about 2 Hz, between about 1.5 Hz and about 2.5 Hz, between about 2 Hz and about 3 Hz, between about 2.5 Hz and about 3.5 Hz, between about 3 Hz and about 4 Hz, between about 3.5 Hz and about 4.5 Hz, between about 4 Hz and about 5 Hz, between about 4.5 Hz and about 5.5 Hz, between about 5 Hz and about 6 Hz, between about 5.5 Hz and about 6.5 Hz, between about 6 Hz and about 7 Hz, between about 6.5 Hz and about 7.5 Hz, between about 7 Hz and about 8 Hz, between about 7.5 Hz and about 8.5 Hz, and between about 8 Hz to about 9 Hz, between about 8.5 Hz to about 9.5 Hz, and between about 9 Hz to about 10 Hz.

[0147] Depending on the method of use, one or more pressure wave frequencies 79 can be generated using the external auditory canal pressure regulating device 1, which may be further affected by factors such as the anatomy of the user 23, the physiology or biochemistry of the auditory canal 24; the symptoms of the condition to be alleviated; the condition to be treated; the observable effects of using one or more pressure wave frequencies 79 in a specific method of using the external auditory canal pressure regulating device 1; or a combination thereof; but not so much as to cause discomfort to the user 23 or damage to the auditory canal 24 or tympanic membrane 25.

[0148] The pressure wave 78 may oscillate with only a positive pressure amplitude 77 within a desired pressure wave frequency 79 within a range between 110 kPa and about +50 kPa above ambient pressure. FIG. 14B to FIG. 14GAs shown in the example of , this can generate a positive external auditory canal pressure 10 relative to the ambient pressure 11 by increasing the external auditory canal pressure 10 relative to the ambient pressure 11, for example, to relieve symptoms of a disease or treat a disease. As for other specific embodiments, the pressure wave 78 can only oscillate with a desired pressure wave frequency 79 within the negative pressure amplitude 77 (in the range of about -50 kPa to 0 kPa below the ambient pressure 11) (such as FIG. 15B to FIG. 15G ), this can be done by reducing the external auditory canal pressure 10 relative to the ambient pressure 11 and correspondingly generating a negative external auditory canal pressure 10 relative to the ambient pressure 11, for example to alleviate symptoms of a disease or treat a disease.

[0149] Again, the main reference FIG. 14B to FIG. 15G Depending on the application, the pressure wave 78 can have numerous and various waveforms, corresponding to numerous and various symptoms that can be alleviated or conditions that can be treated by operating the external auditory canal pressure regulating device 1. As an illustrative example, the pressure wave 78 can be a sine wave with smooth, repetitive periodic oscillations (such as Fig. 14B and Fig. 15B ), a square wave, a rectangular wave, a trapezoidal wave that causes the pressure amplitude 77 to alternate between a fixed minimum value and a maximum value at a stable frequency, or a truncated wave (such as Fig. 14C , Fig. 15C , Fig.14F and Fig.15F ), a triangular wave with linear leading and trailing edges (as shown in the example Fig.14D and Fig.15D ), a sawtooth wave (such as a wave that changes the pressure amplitude 77 at the leading edge within a period 76 greater than the period 76 at which the pressure amplitude 77 at the trailing edge is changed) Fig.14E ), a reverse sawtooth wave (such as Fig.15E ) or a combination thereof (such as Figure 14G and Figure 15G ).

[0150] As for the specific implementation, the fluid flow generator 2 and the third valve pressure relief element 72 coupled to the third valve 58 may be operated alternately and repeatedly to generate the fluid flow 8 having the pressure wave 78 including the pressure wave amplitude 77 and the pressure wave frequency 79 .

[0151] Now the main reference FIG. 14A to FIG. 14G , which shows the pressure difference 9 between the external auditory canal pressure 10 and the ambient pressure 11 achieved in a time period 76 by operating an embodiment of the external auditory canal pressure regulating device 1, so as to generate a positive external auditory canal pressure 10 relative to the ambient pressure 11 (such as Figure 2A , Figure 5 as well as FIG. 11A to FIG. 11D ). A specific embodiment of the external auditory canal pressure regulating device 1 includes a third valve 58, which maintains a substantially leak-proof state for the fluid flow 8 in the third fluid flow conduit 57 when the pressure difference amplitude 59 between the external auditory canal pressure 10 and the ambient pressure 11 is up to about 50 kPa (represented in each graph as the pressure amplitude 77 is zero). However, this does not necessarily limit the implementation to only those that are capable of generating a positive external auditory canal pressure 10 preselected to a maximum of +50 kPa relative to the ambient pressure 11. Other embodiments can be operated to generate a positive external auditory canal pressure 10 relative to the ambient pressure 11 that can be any amount greater than the ambient pressure 11, but not so much as to cause discomfort to the user 23 or damage to the auditory canal 24 or the tympanic membrane 25.

[0152] Now the main reference Fig.14A As for a specific embodiment, the fluid flow generator 2 can be operated to generate an external auditory canal pressure 10 having a maximum pressure amplitude 77 of up to about +50 kPa above the ambient pressure 11. The external auditory canal pressure 10 can be maintained at about +50 kPa above the ambient pressure 11 for a period 76. After the period 76, the third valve pressure relief element 72 can be operated to restore the external auditory canal pressure 10 to the ambient pressure 11. The operation can be repeated, but not necessarily.

[0153] Now the main reference Fig. 14B As for a specific embodiment, the fluid flow generator 2 can be operated to generate an external auditory canal pressure 10 having a maximum pressure amplitude 77 of up to about +50 kPa above the ambient pressure 11. The third valve pressure relief element 72 can be operated to restore the external auditory canal pressure 10 to the ambient pressure 11, whereby the pressure wave 78 can be a sine wave with smooth, repeating periodic oscillations. The operation can be repeated to apply pulsatile changes in the external auditory canal pressure 10.

[0154] Now the main reference Fig.14D As for a specific embodiment, the fluid flow generator 2 can be operated to generate an external auditory canal pressure 10 having a maximum pressure amplitude 77 of up to about +50 kPa above the ambient pressure 11. The third valve pressure relief element 72 can be operated to restore the external auditory canal pressure 10 to the ambient pressure 11, whereby the pressure wave 78 can be a triangular wave with linear leading and trailing edges. The operation can be repeated to apply a pulsatile change in the external auditory canal pressure 10.

[0155] Now the main reference Fig.14EAs for a specific embodiment, the fluid flow generator 2 can be operated to generate an external auditory canal pressure 10 having a maximum pressure amplitude 77 of up to about +50 kPa above the ambient pressure 11. The third valve pressure relief element 72 can be operated to restore the external auditory canal pressure 10 to the ambient pressure 11, whereby the pressure wave 78 can be a sawtooth wave that causes the leading edge to change the pressure amplitude 77 within a period 76 greater than the period 76 that causes the trailing edge to change the pressure amplitude 77. The operation can be repeated to apply a pulsatile change in the external auditory canal pressure 10.

[0156] Now the main reference Fig. 14C and Fig.14F As for a specific embodiment, the fluid flow generator 2 can be operated to generate an external auditory canal pressure 10 having a maximum pressure amplitude 77 of up to about +50 kPa above the ambient pressure 11. The external auditory canal pressure 10 can be maintained at about +50 kPa above the ambient pressure 11 for a period 76. After the period 76, the third valve pressure relief element 72 can be operated to restore the external auditory canal pressure 10 to the ambient pressure 11. The operation can be repeated to apply a pulsatile change in the external auditory canal pressure 10.

[0157] Now the main reference Figure 14G As for a specific embodiment, the fluid flow generator 2 can be operated to increase the external auditory canal pressure 10 during a series of incremental pressure increases, so that the maximum pressure amplitude 77 is about +50 kPa above the ambient pressure 11. The series of incremental pressure increases can increase the external auditory canal pressure 10 to about 10 kPa to about 15 kPa above the ambient pressure 11, and each incremental pressure is increased when the external auditory canal pressure 10 is maintained for a period of time 76. After achieving the maximum pressure amplitude 77 of about +50 kPa above the ambient pressure 11 and after the period of time 76, the third valve pressure relief element 72 can be operated to restore the external auditory canal pressure 10 to the ambient pressure 11. The operation can be repeated to apply a pulsatile change in the external auditory canal pressure 10.

[0158] Now the main reference FIG. 15A to FIG. 15G , which shows the pressure difference 9 between the external auditory canal pressure 10 and the ambient pressure 11 achieved in the time period 76 by operating the embodiment of the external auditory canal pressure regulating device 1, so as to generate a negative external auditory canal pressure 10 relative to the ambient pressure 9 (such as Figure 2B , Figure 6 as well as FIG. 12A to FIG. 12D). A specific embodiment of the external auditory canal pressure regulating device 1 includes a third valve 58, which maintains a substantially leak-proof state for the fluid flow 8 in the third fluid flow conduit 57 when the pressure difference amplitude 59 between the external auditory canal pressure 10 and the ambient pressure 11 is up to about 50 kPa (represented in each graph as the pressure amplitude 77 is zero). However, this does not necessarily limit the implementation to only those that are capable of generating a negative external auditory canal pressure 10 preselected up to a maximum of -50 kPa relative to the ambient pressure 11. Other embodiments can be operated to generate a negative external auditory canal pressure 10 relative to the ambient pressure 11 that can be any amount less than the ambient pressure 11, but not so large as to cause discomfort to the user 23 or damage to the auditory canal 24 or the tympanic membrane 25.

[0159] Now the main reference Fig.15A As for a specific embodiment, the fluid flow generator 2 can be operated to generate an external auditory canal pressure 10 having a maximum pressure amplitude 77 of up to about -50 kPa below the ambient pressure 11. The external auditory canal pressure 10 can be maintained at about -50 kPa below the ambient pressure 11 for a period of time 76. After the period of time 76, the third valve pressure relief element 72 can be operated to restore the external auditory canal pressure 10 to the ambient pressure 11. The operation can be repeated, but not necessarily repeated.

[0160] Now the main reference Fig. 15B As for a specific embodiment, the fluid flow generator 2 can be operated to generate an external auditory canal pressure 10 having a maximum pressure amplitude 77 of up to about -50 kPa below the ambient pressure 11. The third valve pressure relief element 72 can be operated to restore the external auditory canal pressure 10 to the ambient pressure 11, whereby the pressure wave 78 can be a sine wave with smooth, repeating periodic oscillations. The operation can be repeated to apply pulsatile changes in the external auditory canal pressure 10.

[0161] Now the main reference Fig.15D As for a specific embodiment, the fluid flow generator 2 can be operated to generate an external auditory canal pressure 10 having a maximum pressure amplitude 77 of up to about -50 kPa below the ambient pressure 11. The third valve pressure relief element 72 can be operated to restore the external auditory canal pressure 10 to the ambient pressure 11, whereby the pressure wave 78 can be a triangular wave with linear leading and trailing edges. The operation can be repeated to apply a pulsatile change in the external auditory canal pressure 10.

[0162] Now the main reference Fig.15EAs for a specific embodiment, the fluid flow generator 2 can be operated to generate an external auditory canal pressure 10 having a maximum pressure amplitude 77 of up to about -50 kPa below the ambient pressure 11. The third valve pressure relief element 72 can be operated to restore the external auditory canal pressure 10 to the ambient pressure 11, whereby the pressure wave 78 can be a reverse sawtooth wave that causes the leading edge to change the pressure amplitude 77 within a period 76 less than the period 76 that causes the trailing edge to change the pressure amplitude 77. The operation can be repeated to apply a pulsatile change in the external auditory canal pressure 10.

[0163] Now the main reference Fig. 15C and Fig.15F As for a specific embodiment, the fluid flow generator 2 can be operated to generate an external auditory canal pressure 10 having a maximum pressure amplitude 77 of up to about -50 kPa below the ambient pressure 11. The external auditory canal pressure 10 can be maintained at about -50 kPa below the ambient pressure 11 for a period of time 76. After the period of time 76, the third valve pressure relief element 72 can be operated to restore the external auditory canal pressure 10 to the ambient pressure 11. The operation can be repeated to apply a pulsatile change in the external auditory canal pressure 10.

[0164] Now the main reference Figure 15G As for a specific embodiment, the fluid flow generator 2 can be operated to reduce the external auditory canal pressure 10 during a series of incremental pressure reductions, so that the maximum pressure amplitude 77 is about -50 kPa below the ambient pressure 11. The series of incremental pressure reductions can reduce the external auditory canal pressure 10 to about -10 kPa below the ambient pressure 11 to about -15 kPa, and each incremental pressure is reduced when the external auditory canal pressure 10 is maintained for a period of time 76. After achieving the maximum pressure amplitude 77 of about -50 kPa below the ambient pressure 11 and after the period of time 76, the third valve pressure relief element 72 can be operated to restore the external auditory canal pressure 10 to the ambient pressure 11. The operation can be repeated to apply a pulsatile change in the external auditory canal pressure 10.

[0165] As for specific embodiments, the external auditory canal pressure regulating device 1 can further include a housing 80 having an inner housing surface defining a generally hollow interior space within which components of the external auditory canal pressure regulating device 1 can be housed. As for specific embodiments, the housing 80 can be configured to fill in whole or in part an external ear region 82 of the ear 35 without extending any substantial distance outside of the external auditory canal 24, thereby providing a discrete, unobtrusive, portable configuration that can be used to relieve one or more symptoms of a condition (e.g., neurologically mediated pain) or treat one or more conditions (e.g., craniofacial pain symptoms or headache symptoms).

[0166] Although the fluid flow generator 2 of the above-mentioned external auditory canal pressure regulating device 1 generally delivers a fluid flow 8 of air to the external auditory canal 6 to achieve a pressure difference 9 between the external auditory canal pressure 10 and the ambient pressure 11, this is not intended to limit the various fluids that can be delivered to the external auditory canal 6 by the external auditory canal pressure regulating device 1. As illustrative examples, the various fluids may include: purified gases, such as oxygen, nitrogen, argon, etc.; mixtures of gases at partial pressures; liquids, such as water, oil, alcohol, etc.; or combinations thereof.

[0167] Furthermore, while the transfer of the fluid flow 8, or the fluid volume 12, between components of the external auditory canal pressure regulating device 1, between components of the external auditory canal pressure regulating device 1 and the external auditory canal 6, or between components of the external auditory canal pressure regulating device 1 and the ambient pressure 11 may be generally between a first point and a second point for the sake of simplicity as described above, the transfer of the fluid flow 8 or the fluid volume 12 includes all points between the first point and the second point that are within the manifold fluid flow path 62. For example, the fluid volume 12 transferred from the fluid flow generator 2 to the external auditory canal 6 may travel along the fluid flow path 62, which includes the fluid flow generator 2, the first fluid flow conduit first end 50, the first portion 53 of the first fluid flow conduit 49, the first valve 52, the second portion 54 of the first fluid flow conduit 49, the first fluid flow conduit second end 51, the earpiece first end 31, the axial earpiece hole 4, the earpiece second end 29, and the external auditory canal 6.

[0168] A method for producing a specific embodiment of an external auditory canal pressure regulating device 1 may include: providing a fluid flow generator 2 capable of generating a fluid flow 8; providing a valved pipe 5 capable of being fluidically connected to the fluid flow generator 2, the valved pipe 5 having a first fluid flow pipe 49; providing a first valve 52, the first valve 52 capable of interrupting the first fluid flow pipe 49 to unidirectionally regulate the fluid flow 8 in the first fluid flow pipe 49; and providing an axial earpiece hole 4, the axial earpiece hole 4 being connected between an earpiece first end 31 and an earpiece second end 32 of an earpiece 3, the axial earpiece hole 4 being fluidically connected to the valved pipe 5 opposite to the fluid flow generator 2, the earpiece 3 having a compatible earpiece outer surface 7, the compatible earpiece outer surface 7 being configured to sealably engage the external auditory canal 6 as a barrier between the external auditory canal pressure 10 and the ambient pressure 11.

[0169] The method of producing a specific embodiment of the external auditory canal pressure regulating device 1 may further include providing a fluid flow generator 2 having a configuration capable of generating the fluid flow 8 having a fluid volume 12 in a range between 0 ml and about 20 ml. As for specific embodiments, the fluid volume 12 can have a preselected fluid volume 12 that can be selected from one or more of the following group, which group includes or consists of: between 0 ml and about 2 ml, between about 1 ml and about 3 ml, between about 2 ml and about 4 ml, between about 3 ml and about 5 ml, between about 4 ml and about 6 ml, between about 5 ml and about 7 ml, between about 6 ml and about 8 ml, between about 7 ml and about 9 ml, between about 8 ml and about 10 ml, between about 9 ml and about 11 ml, between about 10 ml and about 12 ml, between about 11 ml and about 13 ml, between about 12 ml and about 14 ml, between about 13 ml and about 15 ml, between about 14 ml and about 16 ml, between about 15 ml and about 17 ml, between about 16 ml and about 18 ml, between about 17 ml and about 19 ml, and between about 18 ml and about 20 ml.

[0170] The method of producing a specific embodiment of the external auditory canal pressure regulating device 1 may further include: providing a valved conduit 5 having a configuration that can be detachably coupled to the fluid flow generator 2 and the earpiece 3. As for a specific embodiment, the method may further include: providing a valved conduit 5 having a configuration that can be coupled to the fluid flow generator 2 and the earpiece 3 in a first configuration 45 to unidirectionally regulate the fluid flow 8 in a first direction 47 in the first fluid flow conduit 49. As for other specific embodiments, the method may further include: providing a valved conduit 5 having a configuration that can be coupled to the fluid flow generator 2 and the earpiece 3 in a second configuration 46 to unidirectionally regulate the fluid flow 8 in a second direction 48 in the first fluid flow conduit 49.

[0171] The method for producing a specific embodiment of the external auditory canal pressure regulating device 1 may further include: providing a first valve 52 having a structure capable of dividing the first fluid flow conduit 49 into a first part 53 close to the first end 50 of the first fluid flow conduit and a second part 54 close to the second end 51 of the first fluid flow conduit, and further including: providing a second fluid flow conduit 55 having a structure capable of being fluidically connected between the first part 53 of the first fluid flow conduit 49 and the ambient pressure 11, and further including: providing a second valve 56 having a structure capable of interrupting the second fluid flow conduit 55 to unidirectionally regulate the fluid flow 8 in the second fluid flow conduit 55.

[0172] The method of producing a specific embodiment of the external auditory canal pressure regulating device 1 may further include: providing a fluid flow generator 2 configured as a volume adjustable element 13 having an internal volume 19, the volume adjustable element 13 having a deformation state 20 that reduces the internal volume 19 to generate the fluid flow 8 in the first fluid flow conduit 49, the first valve 52 unidirectionally regulating the fluid flow 8 to be discharged from the axial earpiece hole 4 of the earpiece 3. As for the specific embodiment, the volume adjustable element 13 can return to a non-deformed state 21 that increases the internal volume 19 to generate the fluid flow 8 in the second fluid flow conduit 55, the second valve 56 unidirectionally regulates the fluid flow 8 to enter from the ambient pressure 11 toward the volume adjustable element 13, and the first valve 52 interrupts the fluid flow 8 in the first fluid flow conduit 49 from the second portion 54 toward the first portion 53.

[0173] The method of producing a specific embodiment of the external auditory canal pressure regulating device 1 may further include: providing a fluid flow generator 2 configured as a volume adjustable element 13 having an internal volume 19, the volume adjustable element 13 having a deformation state 20 that reduces the internal volume 19 to generate the fluid flow 8 in the second fluid flow conduit 55, and the second valve 52 unidirectionally regulating the fluid flow 8 to be discharged from the second fluid flow conduit 55 to the ambient pressure 11. As for a specific embodiment, the volume adjustable element 13 can return to a non-deformed state 21 that increases the internal volume 19 to generate the fluid flow 8 in the first fluid flow conduit 49, the first valve 52 unidirectionally regulates the fluid flow 8 to enter from the axial earpiece hole 4 of the earpiece 3 toward the volume adjustable element 13, and the second valve 56 interrupts the fluid flow 8 in the second fluid flow conduit 55 from the ambient pressure 11 toward the first portion 53.

[0174] The method for producing a specific embodiment of the external auditory canal pressure regulating device 1 may further include: providing a third fluid flow conduit 57 having a structure capable of being fluidically connected between the second portion 54 of the first fluid flow conduit 49 and the ambient pressure 11, and further including: providing a third valve 58 having a structure capable of interrupting the third fluid flow conduit 57 to unidirectionally regulate the fluid flow 8 in the third fluid flow conduit 57. As for specific embodiments, the method may further include: providing a third valve 58 having a structure capable of regulating the fluid flow 8 to be discharged to the ambient pressure 11. As for other specific embodiments, the method for producing a specific embodiment of the external auditory canal pressure regulating device 1 may further include: providing a third valve 58 having a structure capable of regulating the fluid flow 8 to enter from the ambient pressure 11.

[0175] The method of producing a specific embodiment of the external auditory canal pressure regulating device 1 may further include: providing a third valve 58 having a configuration capable of interrupting the fluid flow 8 between the second portion 54 of the first fluid flow conduit 49 and the ambient pressure 11 until the pressure difference 9 between the second portion 54 of the first fluid conduit 49 and the ambient pressure 11 exceeds a preselected pressure difference 9 having a pressure difference amplitude 59 between 0 kPa and about 50 kPa. As for specific embodiments, the one or more preselected pressure difference amplitudes 59 may be selected from the following group, which includes or consists of: between 0 kPa and about 5 kPa, between about 2.5 kPa and about 7.5 kPa, between about 5 kPa and about 10 kPa, between about 7.5 kPa and about 12.5 kPa, between about 10 kPa and about 15 kPa, between about 12.5 kPa and about 17.5 kPa, between about 15 kPa and about 20 kPa, between about 17.5 kPa and about 22.5 kPa, between about 20 kPa and about The present invention relates to a novel nanostructured carbon foam having a thermal conductivity of about 25 kPa to about 25 kPa, about 22.5 kPa to about 27.5 kPa, about 25 kPa to about 30 kPa, about 27.5 kPa to about 32.5 kPa, about 30 kPa to about 35 kPa, about 32.5 kPa to about 37.5 kPa, about 35 kPa to about 40 kPa, about 37.5 kPa to about 42.5 kPa, about 40 kPa to about 45 kPa, about 42.5 kPa to about 47.5 kPa, and about 45 kPa to about 50 kPa.

[0176] The method for producing a specific embodiment of the external auditory canal pressure regulating device 1 may further include: providing a second valve pressure relief element 71 having a structure capable of being connected to the second valve 56 and a third valve pressure relief element 72 having a structure capable of being connected to the third valve 58, each pressure relief element being manually operable to generate the fluid flow 8 in the second fluid flow conduit 55 and the third fluid flow conduit 57 respectively.

[0177] The method of producing a specific embodiment of the external auditory canal pressure regulating device 1 may further include: providing a valved conduit 5 having a configuration capable of being coupled to the fluid flow generator 2 and the earpiece 3 in a first configuration 45 to unidirectionally regulate the fluid flow 8 in the first direction 47 in the first fluid flow conduit 49 to be discharged from the axial earpiece hole 4 of the earpiece 3. As for a specific embodiment, the method may further include: providing a fluid flow generator 2 configured as a volume adjustable element 13 operable from a non-deformed state 21 toward a deformed state 20 to generate the fluid flow 2 discharged from the axial earpiece hole 4 within a period 76.

[0178] The method of producing a specific embodiment of the external auditory canal pressure regulating device 1 may further include: providing a fluid flow generator 2 having a structure capable of repeatedly operating from the non-deformed state 21 toward the deformed state 20 to generate the fluid flow 8 having a pressure wave 78 including a pressure wave amplitude 77 and a pressure wave frequency 79. As for a specific embodiment, the pressure wave frequency 79 may be in a range between 0 Hz and about 10 Hz. As to a specific embodiment, one or more pressure wave frequencies 79 can be selected from the group consisting of: between 0 Hz and about 1 Hz, between about 0.5 Hz and about 1.5 Hz, between about 1 Hz and about 2 Hz, between about 1.5 Hz and about 2.5 Hz, between about 2 Hz and about 3 Hz, between about 2.5 Hz and about 3.5 Hz, between about 3 Hz and about 4 Hz, between about 3.5 Hz and about 4.5 Hz, between about 4 Hz and about 5 Hz, between about 4.5 Hz and about 5.5 Hz, between about 5 Hz and about 6 Hz, between about 5.5 Hz and about 6.5 Hz, between about 6 Hz and about 7 Hz, between about 6.5 Hz and about 7.5 Hz, between about 7 Hz and about 8 Hz, between about 7.5 Hz and about 8.5 Hz, and between about 8 Hz to about 9 Hz, between about 8.5 Hz to about 9.5 Hz, and between about 9 Hz to about 10 Hz.

[0179] The method for producing a specific embodiment of the external auditory canal pressure regulating device 1 may further include: providing a third valve pressure relief element 72 having a structure capable of being connected to the third valve 56, whereby the fluid flow generator 2 and the third valve pressure relief element 72 can be capable of alternating and repeatedly operating to generate the fluid flow 2 having the pressure wave 78 including the pressure wave amplitude 77 and the pressure wave frequency 79.

[0180] The method of producing a specific embodiment of the external auditory canal pressure regulating device 1 may further include: providing a valved conduit 5 having a configuration capable of being coupled to the fluid flow generator 2 and the earpiece 3 in a second configuration 46 to unidirectionally regulate the fluid flow 8 in the first fluid flow conduit 49 in a second direction 48 to enter the axial earpiece hole 4 of the earpiece 3. As for a specific embodiment, the method may further include: providing a fluid flow generator 2 configured as a volume adjustable element 13 operable from a deformed state 20 toward a non-deformed state 21 to generate the fluid flow 2 entering from the axial earpiece hole 4 within a period 76.

[0181] The method of producing a specific embodiment of the external auditory canal pressure regulating device 1 may further include: providing a fluid flow generator 2 having a structure capable of repeatedly operating from the deformed state 20 toward the non-deformed state 21 to generate the fluid flow 8 having a pressure wave 78 including a pressure wave amplitude 77 and a pressure wave frequency 79. As for a specific embodiment, the pressure wave frequency 79 may be in a range between 0 Hz and about 10 Hz. As to a specific embodiment, one or more pressure wave frequencies 79 can be selected from the group consisting of: between 0 Hz and about 1 Hz, between about 0.5 Hz and about 1.5 Hz, between about 1 Hz and about 2 Hz, between about 1.5 Hz and about 2.5 Hz, between about 2 Hz and about 3 Hz, between about 2.5 Hz and about 3.5 Hz, between about 3 Hz and about 4 Hz, between about 3.5 Hz and about 4.5 Hz, between about 4 Hz and about 5 Hz, between about 4.5 Hz and about 5.5 Hz, between about 5 Hz and about 6 Hz, between about 5.5 Hz and about 6.5 Hz, between about 6 Hz and about 7 Hz, between about 6.5 Hz and about 7.5 Hz, between about 7 Hz and about 8 Hz, between about 7.5 Hz and about 8.5 Hz, and between about 8 Hz to about 9 Hz, between about 8.5 Hz to about 9.5 Hz, and between about 9 Hz to about 10 Hz.

[0182] The method for producing a specific embodiment of the external auditory canal pressure regulating device 1 may further include: providing a third valve pressure relief element 72 having a structure capable of being connected to the third valve 56, whereby the fluid flow generator 2 and the third valve pressure relief element 72 can be capable of alternating and repeatedly operating to generate the fluid flow 2 having the pressure wave 78 including the pressure wave amplitude 77 and the pressure wave frequency 79.

[0183] As for specific embodiments, the components of the external auditory canal pressure regulating device 1 can be formed entirely of the same material, or alternatively, the various components of the external auditory canal pressure regulating device 1 can be formed of different materials. In addition, as for specific embodiments, depending on the application, the external auditory canal pressure regulating device 1 or the components of the external auditory canal pressure regulating device 1 can be produced by any of a variety of processes, such as compression molding, injection molding, manufacturing, machining, printing, three-dimensional printing, etc., or a combination thereof, as one piece or assembled from multiple pieces into an embodiment of the external auditory canal pressure regulating device 1 or configured to be assembled into multiple pieces of an embodiment of the external auditory canal pressure regulating device 1.

[0184] The components of the external auditory canal pressure regulating device 1 can be produced from any of a variety of materials that can provide an embodiment of the external auditory canal pressure regulating device 1 that is useful for generating and regulating the fluid flow 1. By way of non-limiting example, the valved conduit 1 can be produced from a variety of elastomeric compounds, plastics, plastic-like materials, acrylics, polyamides, polyesters, polypropylenes, polyvinyl chloride-based materials, silicone-based materials, etc. or combinations thereof.

[0185] A method of using a specific embodiment of an external auditory canal pressure regulating device 1 may include: obtaining the external auditory canal pressure regulating device 1, the external auditory canal pressure regulating device 1 including a fluid flow generator 2 for generating a fluid flow; a valved conduit 5 fluidically coupled to the fluid flow generator 2, the valved conduit 5 having a first fluid flow conduit 49 that can be interrupted by a first valve 52 to unidirectionally regulate the fluid flow 8 in the first fluid flow conduit 49; and an earpiece 3 having an axis connected between an earpiece first end 31 and an earpiece second end 29. Toward the earpiece hole 4, the axial earpiece hole 4 is fluidically connected to the valved pipe 5 opposite to the fluid flow generator 2, the earpiece 3 has a compatible earpiece outer surface 7 configured to sealably engage the external auditory canal 6 to serve as a barrier between the external auditory canal pressure 10 and the ambient pressure 11; the earpiece outer surface 7 of the earpiece 3 is sealably engaged with the external auditory canal 6; the fluid flow 8 is generated between the fluid flow generator 2 and the axial earpiece hole 4; and the pressure difference 9 between the external auditory canal pressure 10 and the ambient pressure 11 is adjusted.

[0186] As for a specific embodiment, a method for using an external auditory canal pressure regulating device 1 may include: obtaining an external auditory canal pressure regulating device 1, the external auditory canal pressure regulating device 1 including a fluid flow generator 2 for generating a fluid flow 8; a valved pipe 5, the valved pipe 5 having a first fluid flow pipe 49 which can be interrupted by a first valve 52 to unidirectionally regulate the fluid flow 8 in the first fluid flow pipe 49; and an earpiece 3, the earpiece 3 having an axial earpiece hole 4 communicating between an earpiece first end 31 and an earpiece second end 29, the earpiece 3 having a compatible earpiece outer canal which is configured to sealably engage an external auditory canal 6 to serve as a barrier between an external auditory canal pressure 10 and an ambient pressure 11. surface 7; fluidically connecting the valved conduit 5 in the first structure 45 to the fluid flow generator 2 and the axial earpiece hole 4 of the earpiece 3 to unidirectionally regulate the fluid flow 8 in the first direction 47 in the first fluid flow conduit 49; making the earpiece outer surface 7 of the earpiece 3 sealably engageable with the external auditory canal 6; generating the fluid flow 8 between the fluid flow generator 2 and the axial earpiece hole 4 in the first direction 47 in the first fluid flow conduit 49; and regulating the pressure difference 9 between the external auditory canal pressure 10 and the ambient pressure 11, wherein the external auditory canal pressure 10 is greater than the ambient pressure 11.

[0187] As for a specific embodiment, the method of using the external auditory canal pressure regulating device 1 may further include: operating the pressure relief element 70 to generate the fluid flow 8 from the external auditory canal 6 toward the ambient pressure 11, so that the external auditory canal pressure 10 is restored to the ambient pressure 11. As for a specific embodiment, the method may further include: separating the earpiece outer surface 7 of the earpiece 3 from the external auditory canal 6.

[0188] As for a specific embodiment, the method of using the external auditory canal pressure regulating device 1 may further include: disconnecting the valved tube 5 in the first structure 45 from the fluid flow generator 2 and the axial earpiece hole 4 of the earpiece 3 .

[0189] As for a specific embodiment, the method of using the external auditory canal pressure regulating device 1 may further include: fluidically connecting the valved tube 5 in the second structure 46 to the fluid flow generator 2 and the axial earpiece hole 4 of the earpiece 3 to unidirectionally regulate the fluid flow 8 in the second direction 48 in the first fluid flow tube 49; making the earpiece outer surface 7 of the earpiece 3 sealably engage with the external auditory canal 7; generating the fluid flow 8 between the fluid flow generator 2 and the axial earpiece hole 4 in the first fluid flow tube 49 in the second direction 48; and regulating the pressure difference 9 between the external auditory canal pressure 10 and the ambient pressure 11, wherein the external auditory canal pressure 10 is less than the ambient pressure 11.

[0190] As for a specific embodiment, the method of using the external auditory canal pressure regulating device 1 may further include: operating the pressure relief element 70 to generate the fluid flow 8 from the ambient pressure 11 toward the external auditory canal 6, so that the external auditory canal pressure 10 is restored to the ambient pressure 11. As for a specific embodiment, the method may further include: separating the earpiece outer surface 7 of the earpiece 3 from the external auditory canal 6.

[0191] As for a specific embodiment, the method of using the external auditory canal pressure regulating device 1 may further include: disconnecting the valved tube 5 in the second structure 46 from the fluid flow generator 2 and the axial earpiece hole 4 of the earpiece 3 .

[0192] As can be readily appreciated from the foregoing, the basic concepts of the present invention can be implemented in a variety of ways. The present invention relates to numerous and varied embodiments of an external auditory canal pressure regulating device and methods for making and using such an external auditory canal pressure regulating device (including the best mode).

[0193] Therefore, the specific embodiments or the elements of the invention disclosed by the description or shown in the drawings or appended tables of the present application are not intended to be limiting, but rather are exemplary of the numerous and varied embodiments generally encompassed by the invention or the equivalents encompassed with respect to any specific element thereof. In addition, the specific description of a single embodiment or element of the invention may not explicitly describe all possible embodiments or elements; many alternatives are implicitly disclosed by the description and drawings.

[0194] It should be understood that each element of the device or each step of the method can be described by device terms or method terms. Such terms can be replaced, and it is expected that the rights of the present invention are clearly implicitly widely covered. As an example, it should be understood that all steps of the method can be disclosed as actions, means for taking this action, or elements that cause this action. Similarly, each element of the device can be disclosed as a physical element or an action driven by a physical element. As an example, the disclosed "fluid flow" should be understood to include the disclosed "flowing fluid" action regardless of whether it is explicitly discussed or not, and conversely effectively discloses the action of "flowing fluid", and such disclosure should be understood to include the disclosed "fluid flow" or even "means for fluid flow". Such alternative terms for each element or step should be understood to be explicitly included in the description.

[0195] Additionally, as to each term used, it should be understood that, unless usage in this application is inconsistent with such interpretation, the ordinary dictionary definitions should be understood to be included in the description of each term contained in Random House Webster's Unabridged Dictionary, Second Edition, each definition being incorporated herein by reference.

[0196] All numerical values ​​herein are assumed to be modified by the term "about", regardless of whether it is explicitly stated. For the purposes of the present invention, the range can be expressed as from "about" one specific value to "about" another specific value. When expressing such a range, another embodiment includes from one specific value to another specific value. The numerical range detailed by the endpoints includes all numerical values ​​included in this range. One to five numerical ranges include, for example, numerical values ​​1, 1.5, 2, 2.75, 3, 3.80, 4, 5, etc. It will be further understood that the endpoints of each range are significant relative to other endpoints and are independent of other endpoints. When a value is expressed as approximation by means of the prefix "about", it will be understood that the specific value forms another embodiment. The term "about" generally refers to a numerical range that a person skilled in the art will consider to be equivalent to the quoted numerical value or to have the same function or result. Similarly, the prefix "substantially" means the same form, mode or degree to a large extent but not entirely, and a specific element will have a construction range that a person skilled in the art will consider to have the same function or result. When a specific element is expressed as being approximately by means of the prefix “substantially”, it will be understood that the specific element forms another embodiment.

[0197] Moreover, for the purposes of the present invention, the term "a" or "an" entity refers to one or more of this entity, unless otherwise limited. Therefore, the terms "a" or "an", "one or more" and "at least one" can be interchangeable herein.

[0198] Thus, the applicant should be understood to be requesting protection for at least: i) the external auditory canal pressure regulating device disclosed and described herein, ii) the related methods disclosed and described, iii) the analogs, equivalents and even implicit variations of each of these devices and methods, iv) these alternative embodiments for accomplishing each function shown, disclosed or described, v) these alternative designs and methods for accomplishing each function disclosed and described that is shown to be implied to be accomplished, vi) each feature, component and step shown as a separate and independent invention, vii) applications enhanced by the various systems or components disclosed, viii) the resulting products produced by such systems or components, ix) methods and apparatus substantially as described above and with reference to any accompanying examples, x) various combinations and arrangements of each previously disclosed element.

[0199] The background section of this patent application provides a statement of the field to which the invention pertains. This section may also incorporate or contain certain U.S. patents, patent applications, publications, or explanations of the subject matter of the claimed invention that are useful for information, problems, or concerns regarding the state of the art of the invention. Any U.S. patent, patent application, publication, statement, or other information cited or incorporated herein is not intended to be construed, constructed, or deemed to be accepted as prior art with respect to the present invention.

[0200] The claims set forth in this specification, if any, are incorporated herein by reference as part of this description of the invention, and applicants expressly reserve the right to use all or part of such incorporated content of such claims as additional description to support any or all of the claims or any elements or components thereof, and applicants further expressly reserve the right to move any or all of the incorporated content of such claims or any elements or components thereof into the claims by description, or vice versa, as necessary to define the subject matter sought to be protected by this application or any subsequent application or continuation, divisional or continuation-in-part application, or to satisfy or comply with the patent laws, regulations or provisions of any country or treaty to obtain any priority, fee reduction, and such incorporated content by reference shall survive the entire pendency of this application (including any subsequent continuation, divisional or continuation-in-part application or any reissue or extension).

[0201] In addition, the claims set forth in this specification, if any, are further intended to describe preferred embodiments of the invention that measure and define a limited number, and are not to be constructed as the broadest embodiment of the invention or to fully list the embodiments of the invention that may be protected. Applicants do not waive any right to further amend the claims based on the description set forth above, as any continuation, divisional, or continuation-in-part application.

Claims

1. A fluid transfer device for treating headache symptoms, the fluid transfer device comprising: a fluid flow generator configured to generate a fluid flow through the earpiece to achieve an external auditory canal pressure differential between an external auditory canal pressure and an ambient pressure; as well as a valved conduit in fluid communication with the fluid flow generator, the valved conduit having a first configuration and a second configuration; wherein the fluid flow generator is configured to increase a positive pressure difference between the external auditory canal pressure and the ambient pressure when the valved conduit is in the first configuration; wherein the fluid flow generator is configured to increase the negative pressure difference between the external auditory canal pressure and the ambient pressure when the valved conduit is in the second configuration; and Wherein, the external auditory canal pressure difference can effectively treat the headache symptoms.

2. The fluid delivery device for treating headache symptoms according to claim 1, wherein: The fluid flow generator is configured to generate the fluid flow in a first direction when the valved conduit is in the first configuration.

3. The fluid delivery device for treating headache symptoms according to claim 2, wherein: The fluid flow generator is configured to unidirectionally regulate the fluid flow in the first direction when the valved conduit is in the first configuration.

4. A fluid delivery device for treating headache symptoms according to claim 2 or 3, wherein: The fluid flow generator is configured to generate the fluid flow in a second direction when the valved conduit is in the second configuration, wherein the second direction is opposite to the first direction.

5. The fluid delivery device for treating headache symptoms according to claim 4, wherein: The fluid flow generator is configured to unidirectionally regulate the fluid flow in the second direction when the valved conduit is in the second configuration.

6. A fluid delivery device for treating headache symptoms according to any one of claims 1 to 3, wherein: The valved conduit is configured to rotate to transition between the first configuration and the second configuration.

7. The fluid delivery device for treating headache symptoms according to claim 6, wherein: The valved conduit is configured to rotate without any structural changes.

8. A fluid delivery device for treating headache symptoms according to any one of claims 1 to 3, wherein: The valved conduit is removably coupled to the fluid flow generator.

9. A fluid delivery device for treating headache symptoms according to any one of claims 1 to 3, further comprising a pressure relief element, the pressure relief element restoring the external auditory canal pressure toward the ambient pressure.

10. A fluid delivery device for treating headache symptoms according to any one of claims 1 to 3, further comprising a fluid flow manifold which can be interrupted by operation of one or more valves.

11. A fluid delivery device for treating headache symptoms according to any one of claims 1 to 3, further comprising an earpiece.

12. The fluid delivery device for treating headache symptoms of claim 11, wherein: The earpiece includes an earplug configured to sealingly engage an external auditory canal wall to serve as a barrier between external auditory canal pressure and ambient pressure.

13. A fluid delivery device for treating headache symptoms according to any one of claims 1 to 3, wherein: The external auditory canal pressure differential is configured to cause the eardrum to move.

14. A fluid delivery device for treating headache symptoms according to any one of claims 1 to 3, wherein: The fluid flow generator is configured to generate the fluid flow with pressure waves.

15. The fluid delivery device for treating headache symptoms of claim 14, wherein: The pressure wave includes a pressure wave amplitude and a pressure wave frequency.

16. The fluid delivery device for treating headache symptoms of claim 15, wherein: The pressure wave frequency is in the range of 0 Hz to 10 Hz.

17. The fluid delivery device for treating headache symptoms of claim 15, wherein: The pressure wave frequency is selected from one or more of the group consisting of: between 0 Hz and 1 Hz, between 0.5 Hz and 1.5 Hz, between 1 Hz and 2 Hz, between 1.5 Hz and 2.5 Hz, between 2 Hz and 3 Hz, between 2.5 Hz and 3.5 Hz, between 3 Hz and 4 Hz, between 3.5 Hz and 4.5 Hz, between 4 Hz and 5 Hz, between 4.5 Hz and 5.5 Hz, between 5 Hz and 6 Hz, between 5.5 Hz and 6.5 Hz, between 6 Hz and 7 Hz, between 6.5 Hz and 7.5 Hz, between 7 Hz and 8 Hz, between 7.5 Hz and 8.5 Hz, between 8 Hz and 9 Hz, between 8.5 Hz and 9.5 Hz, and between 9 Hz and 10 Hz.

18. The fluid delivery device for treating headache symptoms of claim 14, wherein: The pressure wave comprises a waveform.

19. The fluid delivery device for treating headache symptoms of claim 18, wherein: The fluid flow generator is configured to generate the waveform to treat the headache symptom.

20. The fluid delivery device for treating headache symptoms of claim 18, wherein: The waveform includes at least one of the following: a sine wave, a square wave, a rectangular wave, a trapezoidal wave, a truncated wave, a triangle wave, a sawtooth wave, a reverse sawtooth wave, and combinations thereof.

21. A fluid delivery device for treating headache symptoms according to any one of claims 1 to 3, further comprising a housing configured to accommodate the fluid flow generator.

22. The fluid delivery device for treating headache symptoms of claim 21, wherein: The shell is configured to fill the concha region of the ear.

23. A fluid delivery device for treating headache symptoms according to any one of claims 1 to 3, wherein: The external auditory canal pressure difference effectively alleviates one or more symptoms selected from the group consisting of: dizziness; vertigo; nausea; imbalance; paresthesia; Insensitivity to light; sensitivity to smells; sensitivity to sounds; loss of appetite; blurred vision; intestinal disturbances; acute pain, including throbbing, tearing, sharp, dull, deep, stabbing, burning, aching, stabbing, intense, sudden, feeling of swelling or tingling; chronic pain, including throbbing, tearing, sharp, dull, deep, stabbing, burning, aching, stabbing, intense, sudden, feeling of swelling or tingling; and combinations thereof.

24. A fluid delivery device for treating headache symptoms according to any one of claims 1 to 3, wherein: The headache symptoms include migraine.

25. A fluid delivery device for treating headache symptoms according to any one of claims 1 to 3, wherein: The fluid flow generator is configured to generate the fluid flow having a fluid volume in a range between 0 milliliters and 20 milliliters.

26. The fluid delivery device for treating headache symptoms of claim 25, wherein: The fluid volume has a preselected fluid volume.

27. The fluid delivery device for treating headache symptoms of claim 26, wherein: The preselected fluid volume is selected from the following group, the composition of which is as follows: between 0 ml and 2 ml, between 1 ml and 3 ml, between 2 ml and 4 ml, between 3 ml and 5 ml, between 4 ml and 6 ml, between 5 ml and 7 ml, between 6 ml and 8 ml, between 7 ml and 9 ml, between 8 ml and 10 ml, between 9 ml and 11 ml, between 10 ml and 12 ml, between 11 ml and 13 ml, between 12 ml and 14 ml, between 13 ml and 15 ml, between 14 ml and 16 ml, between 15 ml and 17 ml, between 16 ml and 18 ml, between 17 ml and 19 ml, and between 18 ml and 20 ml.

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