External auditory canal pressure adjusting device

Abstract

The invention relates to an external auditory canal pressure regulating device. An auditory meatus pressure regulation device for treating migraine, the device comprising: an earpiece for insertion into an external auditory meatus, the earpiece is configured to sealingly engage the external auditory canal as a barrier between external auditory canal pressure and ambient pressure to maintain a seal between the earpiece and the external auditory canal of a patient with a pressure difference between the external auditory canal pressure and the ambient pressure; and a pressure regulator defining a flow rate of fluid between the earpiece and an ambient environment outside the ear, the flow rate defined to reduce the pressure difference between the external auditory canal pressure and the ambient pressure over a period of time; wherein the pressure difference between the external auditory canal pressure and the ambient pressure is effective to relieve pain of the migraine.

Description

[0001] This application is a divisional application of the invention patent application with the application number 202210310578.1, the application date of June 25, 2014, and the invention title of "External Auditory Canal Pressure Regulation Device". The aforementioned invention application is a divisional application of the invention patent application with the application number 201810441770.8, the application date of June 25, 2014, and the invention title of "External Auditory Canal Pressure Regulation Device". The aforementioned invention patent application is a divisional application of the invention patent application with the application number 201480042665.7 (international application number PCT / US2014 / 044159), the international application date of June 25, 2014, and the invention title of "External Auditory Canal Pressure Regulation Device". Technical Field

[0002] This application relates to an external auditory canal pressure regulation device. Background Art

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

[0004] Regarding migraines, accompanying symptoms such as pain, nausea, aura, photophobia, sensory disturbances, dizziness, vertigo, and balance disorders 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 total 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 of depression and suicidal tendencies. Thus, clinicians and researchers are carefully continuing to search for effective devices and methods to relieve symptoms associated with these conditions or to treat the conditions.

[0005] Standard pharmaceutical therapies for migraines are generally prescribed to prevent or reduce pain. The various agents falling under these two broad categories can exhibit a wide range of effectiveness, yet also cause varying degrees of side effects. From an economic perspective, the cost of these medications can be a major source of financial burden for consumers. Moreover, advanced interventions such as botulinum toxin injections, nerve blocks, neurosurgical lesions, and implantable electrical stimulators can significantly increase treatment-related costs while subjecting the patient to potential anatomical and physiological alterations, without guaranteeing complete or permanent relief of symptoms or resolution of the condition.

[0006] There are emerging areas of understanding and application within neuroscience that seek to effect positive physiological changes in the nervous system via 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 via the process of neuroplasticity to produce adaptive long-term changes. This approach to neurorehabilitation utilizes, but does not necessarily include only, various forms and modalities of receptor activation or deactivation to promote positive neurophysiological adaptation within the central nervous system, including the brain, brainstem, and spinal cord, which can enhance the physiological function of related tissues, organs, and systems.

[0007] There would be significant advantages in providing a device or method that can generate one or more stimuli that can alleviate one or more symptoms associated with a disorder, such as craniofacial pain symptoms or headache symptoms, or treat one or more disorders. SUMMARY OF THE INVENTION

[0008] A broad object of a particular embodiment of the present invention may be to provide an ear canal pressure regulation device that includes: a fluid flow generator that generates a fluid flow; a valved conduit fluidly coupled 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 a receiver having an axial receiver bore that communicates between a first end of the receiver and a second end of the receiver, the axial receiver bore being fluidly coupled to the valved conduit opposite the fluid flow generator, the receiver having a compatible receiver outer surface that is configured to sealingly engage the ear canal as a barrier between ear canal pressure and ambient pressure.

[0009] Another broad object of a particular embodiment of the present invention may be to provide an ear canal pressure regulation device having a valved conduit that is coupled to the fluid flow generator and the receiver in a first configuration to unidirectionally regulate the fluid flow in the first fluid flow conduit in a first direction such that the fluid flow can be discharged from the axial receiver bore of the receiver to the ear canal, thereby achieving an ear canal pressure greater than the ambient pressure.

[0010] Another broad object of a particular embodiment of the present invention may be to provide an ear canal pressure regulation device having a valved conduit that is coupled to the fluid flow generator and the receiver in a second configuration to unidirectionally regulate the fluid flow in the first fluid flow conduit in a second direction such that the fluid flow can enter the axial receiver bore of the receiver from the ear canal, thereby achieving an ear canal pressure less than the ambient pressure.

[0011] Another broad object of the specific embodiments of the present invention may be to provide an external auditory canal pressure regulating device having a valved conduit 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. Additionally, 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 second direction in the first fluid flow conduit.

[0012] Another broad object of the specific embodiments of the present invention may be to provide a method of manufacturing 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 fluidly coupled to the fluid flow generator, the valved conduit having a first fluid flow conduit; providing 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 bore communicating between a first earpiece end and a second earpiece end of the earpiece, the axial earpiece bore fluidly coupled to the valved conduit opposite the fluid flow generator, the earpiece having a compatible earpiece outer surface configured to sealingly engage the external auditory canal as a barrier between the external auditory canal pressure and the ambient pressure.

[0013] Another broad object of the specific embodiments of the present invention may be to provide a method of using an external auditory canal pressure regulating device, the method comprising: obtaining an external auditory canal pressure regulating device including a fluid flow generator capable of generating a fluid flow; a valved conduit fluidly coupled to the fluid flow generator, the valved conduit having a first fluid flow conduit interruptible by one or more valves to unidirectionally regulate the fluid flow in the first fluid flow conduit; and an earpiece having an axial earpiece bore communicating between a first earpiece end and a second earpiece end, the axial earpiece bore fluidly coupled to the valved conduit opposite the fluid flow generator, the earpiece having a compatible earpiece outer surface configured to sealingly engage the external auditory canal as a barrier between the external auditory canal pressure and the ambient pressure; sealingly engaging the earpiece outer surface of the earpiece with the external auditory canal; generating a fluid flow between the fluid flow generator and the axial earpiece bore; and regulating the pressure differential between the external auditory canal pressure and the ambient pressure.

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

[0015] Figure 1A Illustrates a specific embodiment of an external ear canal pressure regulating device that can be sealingly engaged with the external ear canal.

[0016] Figure 1B Illustrates a specific embodiment of an external ear canal pressure regulating device that can be sealingly engaged with the external ear canal.

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

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

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

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

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

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

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

[0024] Figure 4A Illustrates a specific embodiment of an external ear canal pressure regulating device.

[0025] Figure 4B Illustrates a specific embodiment of an external ear canal pressure regulating device.

[0026] Figure 4C Illustrates a specific embodiment of an external ear canal pressure regulating device.

[0027] Figure 4D Illustrates a specific embodiment of an external ear canal pressure regulating device.

[0028] Figure 4E Illustrates a specific embodiment of an external ear canal pressure regulating device.

[0029] Figure 4F Illustrates a specific embodiment of an external auditory canal pressure regulating device.

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

[0031] Figure 4H Illustrates a specific embodiment of an external auditory canal pressure regulating device.

[0032] Figure 4I Illustrates a specific embodiment of an 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 the ambient pressure.

[0034] Figure 6 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 less than the ambient pressure.

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

[0036] Figure 8 Illustrates a first configuration of an external auditory canal pressure regulating device that is operable to achieve an external auditory canal pressure greater than the ambient pressure.

[0037] Figure 9 Illustrates a method of restructuring Figure 8 The first configuration of the external auditory canal pressure regulating device shown by rotating the pipe body end to end.

[0038] Figure 10 Illustrates a second configuration of an external auditory canal pressure regulating device that is operable to achieve an external auditory canal pressure less than the ambient pressure and is achieved by rotating the pipe body end to end.

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

[0040] Figure 11B Illustrates a first configuration of an external auditory canal pressure regulating device having an earpiece outer surface that is sealably engageable with the external auditory canal and having a fluid flow generator in a deformed state that generates sufficient pressure in a valved pipe 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] Figure 11C Illustrates a first configuration of an external ear canal pressure regulating device having an earphone outer surface that sealingly engages with the external ear 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 the external ear canal pressure and placing a second valve in an open state to generate a fluid flow from the ambient pressure towards the fluid flow generator.

[0042] Figure 11D Illustrates a first configuration of an external ear canal pressure regulating device having an earphone outer surface that sealingly engages with the external ear canal and having a third valve that is manually placed in an open state by operating a pressure relief element to generate a fluid flow from the external ear canal towards the ambient pressure to cause the external ear canal pressure to return to the ambient pressure.

[0043] Figure 12A Illustrates a second configuration of an external ear canal pressure regulating device having an earphone outer surface that sealingly engages with the external ear canal.

[0044] Figure 12B Illustrates a second configuration of an external ear canal pressure regulating device having an earphone outer surface that sealingly engages with the external ear canal and having a fluid flow generator in a deformed state, the fluid flow generator generating sufficient pressure in a valve-equipped conduit to place the second valve in an open state to provide a fluid flow towards the ambient pressure while maintaining the external ear canal pressure at the ambient pressure.

[0045] Figure 12C Illustrates a second configuration of an external ear canal pressure regulating device having an earphone outer surface that sealingly engages with the external ear canal and having 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 ear canal towards the fluid flow generator, thereby generating an external ear canal pressure less than the ambient pressure.

[0046] Figure 12D Illustrates a second configuration of an external ear canal pressure regulating device having an earphone outer surface that sealingly engages with the external ear canal and having a third valve that is manually placed in an open state by operating a pressure relief element to generate a fluid flow from the ambient pressure towards the external ear canal to cause the external ear canal pressure to return to the ambient pressure.

[0047] Figure 13A Is a top view of a specific embodiment of an external ear canal pressure regulating device.

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

[0049] Figure 13C It is an exploded view of a specific embodiment of the external auditory canal pressure regulating device.

[0050] Figure 13D It is an exploded view of a specific embodiment of the external auditory canal pressure regulating device.

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

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

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

[0054] Figure 14B It is a plot of the external auditory canal pressure relative to the ambient pressure achieved over a period of time, which represents a method of using a first configuration of 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 (greater than the ambient pressure), and the pressure wave is a sine wave with a smooth repetitive periodic oscillation.

[0055] Figure 14C It is a plot of the external auditory canal pressure relative to the ambient pressure achieved over a period of time, which represents a method of using a first configuration of 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 (greater than the ambient pressure), and the pressure wave is a truncated wave such that the peaks of the pressure wave have a constant pressure over a period of time.

[0056] Figure 14D It is a plot of the external auditory canal pressure relative to the ambient pressure achieved over a period of time, which represents a method of using a first configuration of 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 (greater than the ambient pressure), and the pressure wave is a triangular wave with a linear leading edge and trailing edge.

[0057] Figure 14EA plot of the external auditory canal pressure relative to the ambient pressure achieved over a period of time, which represents a method of using a first configuration 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 sawtooth wave that changes the pressure at the leading edge over a period of time greater than the period of time that changes the pressure at the trailing edge.

[0058] Figure 14F A plot of the external auditory canal pressure relative to the ambient pressure achieved over a period of time, which represents a method of using a first configuration 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 that has a constant pressure at the peak of the pressure wave over a period of time.

[0059] Figure 14G A plot of the external auditory canal pressure relative to the ambient pressure achieved over a period of time, which represents a method of using a first configuration 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).

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

[0061] Figure 15B A plot of the external auditory canal pressure relative to the ambient pressure achieved over a period of time, which represents a method of using a second configuration 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 (less than the ambient pressure), and the pressure wave is a sine wave with a smooth repetitive periodic oscillation.

[0062] Figure 15C A plot of the external auditory canal pressure relative to the ambient pressure achieved over a period of time, which represents a method of using a second configuration 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 (less than the ambient pressure), and the pressure wave is a truncated wave that has a constant pressure at the peak of the pressure wave over a period of time.

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

[0064] Figure 15E Is a plot of the external ear canal pressure relative to the ambient pressure achieved over a period of time, which represents a method of using a second configuration of an external ear canal pressure regulating device, wherein operating a fluid flow generator by intermittent operation of a pressure relief element generates a pulsating external ear canal pressure (less than the ambient pressure), and the pressure wave is a reverse sawtooth wave that changes the pressure of the leading edge in a period of time smaller than the period of time that changes the pressure of the trailing edge.

[0065] Figure 15F Is a plot of the external ear canal pressure relative to the ambient pressure achieved over a period of time, which represents a method of using a second configuration of an external ear canal pressure regulating device, wherein operating a fluid flow generator by intermittent operation of a pressure relief element generates a pulsating external ear canal pressure (less than the ambient pressure), and the pressure wave is a truncated wave that has a constant pressure at the apex of the pressure wave over a period of time.

[0066] Figure 15G Is a plot of the external ear canal pressure relative to the ambient pressure achieved over a period of time, which represents a method of using a second configuration of an external ear canal pressure regulating device, wherein operating a fluid flow generator by intermittent operation of a pressure relief element generates a pulsating external ear canal pressure (less than the ambient pressure). Detailed Description

[0068] Now referring mainly to Figure 1A and Figure 1B illustrates a specific method of using an external ear canal pressure regulating device 1 including one or more of the following components: a fluid flow generator 2, a receiver 3 having an axial receiver hole 4, and a valved conduit 5 fluidly coupled to the fluid flow generator 2 and the axial receiver hole 4. The method of use may include: sealingly engaging the external ear canal 6 with the external receiver surface 7 of the receiver 3, generating a fluid flow 8 between the fluid flow generator 2 and the axial receiver hole 4, and adjusting the pressure differential 9 between the external ear canal pressure 10 and the ambient pressure 11 to relieve one or more symptoms of a disorder or treat one or more disorders.

[0069] For the purposes of the present invention, the term "pressure differential" means the pressure difference between two locations.

[0070] For the purposes of the present invention, the term "pressure difference magnitude" means the numerical value of the pressure difference between two locations. The pressure difference magnitude 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, an external ear canal pressure 10 that is higher than an ambient pressure 1150 kPa and an external ear canal pressure 10 that is lower than an ambient pressure 1150 kPa can both have a pressure difference magnitude 59 of 50 kPa.

[0071] For the purposes of the present invention, the term "external ear canal pressure" means the force applied within the external ear canal 6 and, without limiting the foregoing generality, means the force applied within the external ear canal 6 by a fluid volume 12, a preselected fluid volume 12, or a fluid flow 8 delivered to or generated within the external ear canal 6 by operation of the external ear canal pressure regulating device 1.

[0072] For the purposes of the present invention, as described herein, the term "ambient pressure" means the force externally applied to the external ear canal 6 in the surrounding environment and, without limiting the foregoing generality, means the force applied to the earpiece 3 on an outer surface 7 of the earpiece that is sealably engageable with the external ear canal 6.

[0073] For the purposes of the present invention, the term "preselected" means a parameter such as a fluid volume 12 or a pressure difference magnitude 59 that is determined, for example, by a user 23 of the external ear canal pressure regulating device 1 prior to administration for delivery to, generation within, or administration to the external ear canal 6 by operation of the external ear canal pressure regulating device 1 and subsequently delivered to, generated within, or administered to the external ear canal 6 by operation of the external ear canal pressure regulating device 1. For example, a preselected fluid volume 12 of 10 mL can be selected in advance for delivery to the external ear canal 6 by operation of the external ear canal pressure regulating device 1 and subsequently, the preselected fluid volume 12 of 10 mL can be delivered to the external ear canal 6 by operation of the external ear canal pressure regulating device 1.

[0074] For the purposes of the present invention, the term "symptom" means any discomfort or combination of discomforts associated with a disorder. Without limiting the foregoing generality, symptoms can include: dizziness; vertigo; nausea; imbalance; paresthesia; hypoesthesia; photosensitivity; olfactory sensitivity; phonosensitivity; anxiety; insomnia; irritability; fatigue; anorexia; blurred vision; bowel disorders; acute or chronic pain of varying character, the varying character including but not limited to: throbbing, tearing, sharp, dull, deep, stabbing, burning, aching, pricking, intense, sudden, feeling swollen or tingling, etc.; or combinations thereof.

[0075] For the purposes of the present invention, the term "condition" means a physical or mental state that may be abnormal or unhealthy. Without limiting the foregoing breadth, conditions can include: symptoms of neuropathic craniofacial pain, such as neuralgia, e.g., trigeminal neuralgia; temporomandibular joint symptoms; headache symptoms, such as migraine, chronic daily headache, cluster headache, tension headache, post-traumatic headache, or chronic paroxysmal hemicrania; endolymphatic hydrops; vertigo; tinnitus; symptoms caused by brain injury; symptoms caused by impaired nerve function, including cognitive disorders, such as attention deficit disorder, mood disorders, such as anxiety disorders, or epilepsy; phantom limb; middle ear conditions; inner ear conditions, etc., or combinations thereof.

[0076] Now referring primarily to Figure 2A and Figure 2B , the fluid flow generator 2 can have any of a wide variety of configurations capable of generating a fluid flow 8 between the fluid flow generator 2 and the axial earpiece aperture 4. As to a specific embodiment, the fluid flow generator 2 can include a volume-adjustable element 13 capable of adjusting between a larger volume and a smaller volume. As an illustrative example, adjusting the volume-adjustable element 13 from the larger volume to the smaller volume can generate a fluid flow 8 away from the fluid flow generator 2, and adjusting the volume-adjustable element 13 from the smaller volume to the larger volume can generate a fluid flow 8 toward the fluid flow generator 2.

[0077] As to a specific embodiment, the fluid flow generator 2 can include an airbag 14 or a diaphragm 15 having an elastically flexible wall 16 with a wall outer surface 17 and a wall inner surface 18. The wall outer surface 17 can be configured in any manner that allows the elastically flexible wall 16 to deform (as shown by the examples of Figures 11A to 12D and Figures 13A to 13F ). The wall inner surface 18 can define an internal volume 19 (either in whole or in part as a component with the valved conduit 5). The elastically flexible wall 16 in a deformed state 20 (as shown by the examples of Figure 11B and Figure 12B ) can reduce the internal volume 19, and returning to the non-deformed state 21 (as shown by the examples of Figure 11C and Figure 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 aperture 4, and the fluid flow 8 can be regulated by the valved conduit 5. As to a specific embodiment, the airbag 14 or the diaphragm 15 can have an internal volume 19 in the non-deformed state 21 that may not be sufficient to reach the deformed state 20 to generate a fluid flow 8 or a pressure amount 22 that can cause discomfort to the user 23 of the external ear canal pressure regulating device 1 or damage to the ear canal 24 or the eardrum 25 when the internal volume 19 is fully reduced.

[0078] 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.

[0079] 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.

[0080] 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.

[0081] Again, the main reference Figure 2A and Figure 2B, the earpiece 3 can have a compatible earpiece outer surface 7 that is configured to be inserted into the ear canal 6 of the external 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 and sealingly engageable with the external auditory canal 6 to resist axial or lateral displacement in view of normal anatomical variations of the external auditory canal 6 within a normal operating temperature range between about 20°C (about 68°F) and about 50°C (about 122°F), and to allow generation and maintenance of a normal operating pressure range between about minus 50 kilopascals (–50 kPa) below the ambient pressure 11 and about plus 50 kilopascals (+50 kPa) above the ambient pressure 11.

[0082] 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 sealingly conform to the external auditory canal 6. As to these specific embodiments, the earpiece 3 can be formed, molded, three-dimensionally printed, or otherwise manufactured from any of a multitude and variety of materials that are capable of sealingly engaging 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 combinations thereof.

[0083] As to specific embodiments, the earpiece 3 can be formed of a single material (such as a lower-hardness elastomer). As to other specific embodiments, the earpiece 3 can be formed of multiple layers, such as an inner core layer with a greater hardness surrounded by an outer layer with a lower hardness, or an inner core layer with a lower hardness surrounded by an outer layer with a greater hardness. As to still other specific embodiments, a flexible earpiece wall can define a hollow inner space of the earpiece 3, whereby the flexible earpiece wall can be deformed to allow the earpiece outer surface 7 to sealingly conform to the external auditory canal 6.

[0084] As to specific embodiments, a portion of the earpiece outer surface 7 can taper inwardly towards the second end 29 of the earpiece (as shown in the example of Figures 4A to 4D ). As an illustrative example of a specific embodiment of this configuration, the earpiece outer surface 7 can be configured to taper inwardly towards the second end 29 of the earpiece in a generally frustoconical form (as shown in the example of Figures 4E to 4G ).

[0085] The earpiece outer surface 7 can further include a plurality of circumferential ribs 30 that are arranged in a spaced-apart relationship between the first end 31 and the second end 29 of the earpiece. Each of the plurality of circumferential ribs 30 can extend from the earpiece outer surface 7 to a substantially uniform height; however, as to these embodiments of the earpiece outer surface 7 having a conical configuration, the plurality of circumferential ribs 30 can have a reduced rib diameter 32 approaching the second end 29 of the earpiece (as shown in the example of Figure 4Has shown in the example of). As an illustrative example, the rib diameter 32 of the first circumferential rib 33 near the first end 31 of the earpiece may be about 7 millimeters, and the rib diameter 32 of the last circumferential rib 34 near the second end 29 of the earpiece may be about 4 millimeters. 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. However, the embodiments do not necessarily need to be so limited, and the plurality of circumferential ribs 30 can be configured in any of a wide variety of configurations suitable for insertion into the external auditory canal 6 and sealingly engaging with the external auditory canal 6, thereby serving as a barrier between the external auditory canal pressure 10 and the ambient pressure 11.

[0086] The outer surface 7 of the earpiece can maintain a sealable engagement with the external auditory canal 6 via the frictional force between the outer surface 7 of the earpiece and the external auditory canal 6. As for the specific embodiments, the outer surface 7 of the earpiece can be maintained in engagement with the external auditory canal 6 by being forcibly pushed onto the external auditory canal pressure regulating device 1 during normal operation. As for other specific embodiments, a restraint element coupled to the external auditory canal pressure regulating device 1 may be worn around the ear 35 or the head 36 to assist in retaining the earpiece 3 within the external auditory canal 6.

[0087] Referring again primarily to Figure 2A and Figure 2B , the earpiece 3 can have an axial earpiece bore 4 that communicates between the first end 31 and the second end 29 of the earpiece. The axial earpiece bore 4 near the first end 31 of the earpiece can be fluidly coupled to a valved conduit 5 and is configured to permit fluid flow 8 between the first end 31 and the second end 29 of the earpiece.

[0088] Now referring primarily to Figure 5 and Figure 6 , the earpiece 3 can further include a tubular bolt 37 disposed around the axial earpiece bore 4. The tubular bolt 37 can communicate, in whole or in part, between the first end 31 and the second end 29 of the earpiece, providing a bolt bore 38 that communicates, in whole or in part, between the first end 31 and the second end 29 of the earpiece. For example, within the normal operating temperature range and the normal operating pressure range, the tubular bolt 37 can be sufficiently rigid to reduce or prevent deformation of the axial earpiece bore 4 when the outer surface 7 of the earpiece is in sealable engagement with the external auditory canal 6, thereby maintaining sufficient fluid flow 8 within the axial earpiece bore 4 during the above normal use.

[0089] The tubular bolt 37 may further include a bolt outer surface 39 dimensioned to be removably inserted into the axial earpiece bore 4, for example, to provide adequate fluid sealing within a normal operating temperature range and a normal operating pressure range to maintain a sufficient fluid flow 8 within the axial earpiece bore 4 during such normal use. As to a specific embodiment, the bolt outer surface 39 may further include a plurality of circumferential barbs spaced along the bolt outer surface 39 for assisting in retaining the tubular bolt 37 within the axial earpiece bore 4 and providing fluid sealing.

[0090] As to a specific embodiment including the discrete tubular bolt 37, the earpiece 3 and the tubular bolt 37 may be provided in a one-piece configuration with the earpiece 3 molded or formed around the tubular bolt 37. As to other specific embodiments, the earpiece 3 may be formed or molded to provide increased rigidity proximate the axial earpiece bore 4. However, the embodiments need not be so limited, as any of a wide variety of structures known to those of ordinary skill in the art may be utilized to provide a fluid sealing relationship between the tubular bolt 37 and the axial earpiece bore 4.

[0091] Now referring primarily to Figures 7 to 10 , the ear canal pressure regulating device 1 may include a valved conduit 5 fluidly coupled to the fluid flow generator 2 and the axial earpiece bore 4. As to a specific embodiment, the valved conduit 5 may be included in a conduit body 41 configured to be 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 first conduit end 42 or the second conduit end 43 of the conduit body. The releasable coupling surfaces 44 of the fluid flow generator 2, the releasable coupling surfaces 44 of the earpiece 3, the first conduit end 42, and the second conduit end 43 of the conduit body may have sufficiently similar configurations (as shown by the example of Figure 7 ) to permit the fluid flow generator 2 and the earpiece 3 to be releasably coupled to either the first conduit end 42 or the second conduit end 43 of the conduit body, depending on whether the valved conduit 5 is operated to effect a pressure differential 9 such that the ear canal pressure 10 is greater than the ambient pressure 11 (as shown by the example of Figure 5 ), or whether the valved conduit 5 is operated to effect a pressure differential 9 such that the ear canal pressure 10 is less than the ambient pressure 11 (as shown by the example of Figure 6 ).

[0092] The releasable coupling surface 44 of the fluid flow generator 2, the releasable coupling surface 44 of the earpiece 3, the first end 42 of the duct body, and the second end 43 of the duct body can be matingly engaged. As an illustrative example, the releasable coupling surface 44 can be configured as a helical line for rotatable mating. However, the embodiments are not necessarily so limited, and the releasable coupling surface 44 can be configured in any of a wide variety of ways to allow the duct body 41 including the valved duct 5 to be positioned in a first configuration 45 to operationally achieve a pressure differential 9 where the external auditory canal pressure 10 is greater than the ambient pressure 11 (as shown in the example of Figure 5 ), and further allow the duct body 41 including the valved duct 5 to be positioned in a second configuration 46 to operationally achieve a pressure differential 9 where the external auditory canal pressure 10 is less than the ambient pressure 11 (as shown in the example of Figure 6 ).

[0093] As an illustrative example, the duct body 41 including the valved duct 5 can be positioned in the first configuration 45 by removably coupling the first end 42 of the duct body to the fluid flow generator 2 and removably coupling the second end 43 of the duct body to the earpiece 3 (as shown in the example of FIG. 8). Thus, the fluid flow 8 can be regulated in a first direction 47 in the valved duct 8 to operationally achieve a pressure differential 9 where the external auditory canal pressure 10 is greater than the ambient pressure 11 (as shown in the example of Figure 5 ).

[0094] Regarding the specific implementation, the fluid flow generator 2 can be removed from the first end 42 of the duct body, and the earpiece 3 can be removed from the second end 43 of the duct body to disassemble the first configuration 45. The duct body 41 can be rotated without any structural change to reverse the orientation of the first end 42 and the second end 43 of the duct body (as shown in the example of Figure 9 ). The valved duct 5 can be positioned in the second configuration 46 by removably coupling the first end 42 of the duct body to the earpiece 3 and removably coupling the second end 43 of the duct body to the fluid flow generator 2 (as shown in the example of Figure 10 ). Thus, the fluid flow 8 can be regulated in a second direction 48 in the valved duct 5 to operationally achieve a pressure differential 9 where the external auditory canal pressure 10 is less than the ambient pressure 11 (as shown in the example of Figure 6 ).

[0095] Now mainly referring to Figure 2A 、 Figure 2B 、 Figure 5 and Figure 6, the valve-equipped conduit 5 may include a first fluid flow conduit 49 that communicates between a first end 50 of the first fluid flow conduit and a second end 51 of the first fluid flow conduit. Regarding the specific embodiments of the external ear canal pressure regulating device 1 described herein, the first end 50 of the first fluid flow conduit communicates with the fluid flow generator 2, and the second end 51 of the first fluid flow conduit communicates with the axial earpiece aperture 4 of the earpiece 3, regardless of whether the conduit body 41 is positioned in the first configuration 45 or the second configuration 46.

[0096] The first fluid flow conduit 49 may be interrupted by a first valve 52 to unidirectionally regulate the fluid flow 8 between the first end 50 of the first fluid flow conduit and the second end 51 of the first fluid flow conduit and correspondingly between the fluid flow generator 2 and the axial earpiece aperture 4. In the aforementioned first configuration 45, the fluid flow generator 2 may be sealingly engaged with the first end 50 of the first fluid flow conduit, and the axial earpiece aperture 4 may be sealingly engaged with the second end 51 of the first fluid flow conduit to unidirectionally regulate the fluid flow 8 in a first direction 47 from the fluid flow generator 2 toward the axial earpiece aperture 4. Thus, the external ear canal pressure regulating device 1 that is sealingly engaged with the external ear canal 6 may operatively achieve a pressure difference 9 in which the external ear canal pressure 10 is greater than the ambient pressure 11 by transferring a fluid volume 12 from the fluid flow generator 2 to the external ear canal 6. In the aforementioned second configuration 46, the fluid flow generator 2 may be sealingly engaged with the first end 50 of the first fluid flow conduit, and the axial earpiece aperture 4 may be sealingly engaged with the second end 51 of the first fluid flow conduit to unidirectionally regulate the fluid flow 8 in a second direction 48 from the axial earpiece aperture 4 toward the fluid flow generator 2. Thus, the external ear canal pressure regulating device 1 that is sealingly engaged with the external ear canal 6 may operatively achieve a pressure difference 9 in which the external ear canal pressure 10 is less than the ambient pressure 11 by transferring a fluid volume 12 from the external ear canal 6 to the fluid flow generator 2.

[0097] Referring again primarily to 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 that is adjacent to the first end 50 of the first fluid flow conduit and accordingly adjacent to the fluid flow generator 2; and a second portion 54 that is adjacent to the second end 51 of the first fluid flow conduit and accordingly adjacent to the axial earpiece aperture 4 of the earpiece 3. As for the specific implementation, the valved conduit 5 may further include a second fluid flow conduit 55 that is fluidly coupled between the first portion 53 of the first fluid flow conduit 49 and the ambient pressure 11. As for the specific implementation of the ear canal pressure regulating device 1 described herein, the second fluid flow conduit 55 is fluidly coupled to the first portion 53 of the first fluid flow conduit 49 that is adjacent 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 may be interrupted by a second valve 56 to unidirectionally regulate the fluid flow 8 in the second fluid flow conduit 55.

[0098] Now referring primarily to Figure 2A and Figure 5 , as for the specific implementation of 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 elastically flexible wall 16. The deformed state 20 of the elastically flexible wall 16 can reduce the internal volume 19 to generate a fluid flow 8 in a first direction 47 in the first fluid flow conduit 49 from the fluid flow generator 2 toward the axial earpiece aperture 4 of the earpiece 3. Thus, the first valve 52 and the second valve 56 unidirectionally regulate the fluid flow 8 to discharge from the axial earpiece aperture 4. Accordingly, the ear canal pressure regulating device 1 that is sealingly engageable with the ear canal 6 can operationally achieve a pressure differential 9 such that the ear canal pressure 10 is greater than the ambient pressure 11 by transferring a fluid volume 12 from the fluid flow generator 2 to the ear canal 6.

[0099] The elastically flexible wall 16 of the volume-adjustable element 13 can return to the non-deformed state 21, which can increase the internal volume 19 to generate a fluid flow 8 in the second fluid flow conduit 55. Thus, 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 in the first fluid flow conduit 49 from the axial earpiece aperture 4 toward the fluid flow generator 2. An implementation of the ear canal pressure regulating device 1 that is sealingly engageable with the ear canal 6 can operationally maintain the pressure differential 9, where the ear 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 to return the elastically flexible wall 16 of the volume-adjustable element 13 to the non-deformed state 21.

[0100] Now referring primarily to Figure 2B and Figure 6As for the specific implementation of the second configuration 46 with the fluid flow generator 2, the fluid flow generator 2 includes a volume adjustable element 13 having an internal volume 19 defined by an elastically flexible wall 16. The deformation state 20 of the elastically flexible wall 16 can reduce the internal volume 19 to generate a fluid flow 8 in the second fluid flow conduit 55 from the fluid flow generator 2 towards the ambient pressure 11. 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 towards the ambient pressure 11.

[0101] 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 first fluid flow conduit 49 in the second direction 48. Thereby, 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 in the second fluid flow conduit 55 from the ambient pressure 11 towards the fluid flow generator 2. Therefore, the ear canal pressure regulating device 1 that can be sealingly engaged with the ear canal 6 can operationally achieve and maintain a pressure difference 9, wherein the ear canal pressure 10 can be maintained to be less than the ambient pressure 11 and at the same time transfer the fluid volume 12 from the ear canal 6 to the fluid flow generator 2 to cause the elastically flexible wall 16 of the volume adjustable element 13 to return to the non-deformed state 21.

[0102] Now mainly referring to Figure 2A 、 Figure 2B 、 Figure 5 and Figure 6 As for the specific implementation, the valved conduit 5 can further include a third fluid flow conduit 57 that is fluidly coupled between the second portion 54 of the first fluid flow conduit 49 and the ambient pressure 11. As for the specific implementation of the ear canal pressure regulating device 1 described herein, the third fluid flow conduit 57 is fluidly coupled 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 the second configuration 46.

[0103] 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 the specific implementation, the third valve 58 can regulate the fluid flow 8 to discharge from the third fluid flow conduit 57 towards the ambient pressure 11. As for other specific implementations, the third valve 58 can regulate the fluid flow 8 to enter the third fluid flow conduit 57 from the ambient pressure 11.

[0104] Regarding the specific implementation, the third valve 58 can interrupt the fluid flow 8 in the third fluid flow conduit 57 until the pressure difference 9 between the second part 54 of the first fluid flow conduit 49 and the ambient pressure 11 exceeds a preselected pressure difference 9, the preselected pressure difference 9 having a pressure difference amplitude 59 that is generally in the range between 0 kPa and about 50 kPa; however, depending on the application, the implementation can have a smaller or larger preselected pressure difference amplitude 59. Regarding the specific implementation, the preselected pressure difference amplitude 59 can be selected from the group consisting of or comprising: 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, between about 22.5 kPa and about 27.5 kPa, between about 25 kPa and about 30 kPa, between about 27.5 kPa and about 32.5 kPa, between about 30 kPa and about 35 kPa, between about 32.5 kPa and about 37.5 kPa, between about 35 kPa and about 40 kPa, between about 37.5 kPa and about 42.5 kPa, between about 40 kPa and about 45 kPa, between about 42.5 kPa and about 47.5 kPa, and between about 45 kPa and about 50 kPa.

[0105] Depending on the method of use, one or more preselected pressure difference amplitudes 59 can be generated by the ear canal pressure regulating device 1, possibly further influenced by factors such as the user 23's anatomy, the physiology or biochemistry of the ear canal 24; the symptoms of the condition being alleviated; the condition being treated; the effects observable in the specific method of using the ear canal pressure regulating device 1 when using one or more preselected pressure difference amplitudes 59; or combinations thereof; but not so much as to cause discomfort to the user 23 or damage to the ear canal 24 or the eardrum 25.

[0106] Now mainly referring to Figure 2A and Figure 2B, the valved conduit 5 may include a fluid flow manifold 60, which can be interrupted by operating one or more valves 61 such as a first valve 52, a second valve 56, a third valve 58 or additional valves 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 a specific configuration of the fluid flow manifold 60, and the fluid flow manifold 60 correspondingly defines a specific configuration of the manifold fluid flow path 62, with respect to the configuration of the fluid flow manifold 60 or the manifold fluid flow path 62 of the valved conduit 5, these embodiments do not necessarily need to be so limited, and the embodiments may include any of a wide variety of configurations that can fluidly couple the above-mentioned first fluid flow conduit 49, second fluid flow conduit 55 and third fluid flow conduit 57 (or additional fluid flow conduits), 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 assembled from multiple pieces where the first valve 52, second valve 56 or third valve 58 (or additional valves 61) can be arranged, assembled or otherwise coupled to generate the valved conduit 5 and are not limited to the foregoing breadth, and may include Figures 4A to 6 the configuration of the conduit body 41 shown in the illustrative example of

[0107] Now referring mainly to Figures 3A to 3E , in Figure 2A and Figure 2B the first valve 52, second valve 56 or third valve 58 schematically illustrated may have any type of valve configuration capable of regulating the fluid flow 8 described herein and not limited to the foregoing breadth, and may include a spring-loaded ball check valve 63 (as shown in the example of Figure 3C ), a flap valve 64 having a hinge 94 (as shown in the example of Figure 3B ), a spring-loaded valve having a base and a seatable and deformable circular lip 65 (as shown in the example of Figure 3A ), an umbrella valve 66 (as shown in the example of Figure 3D ), a duckbill valve 67 (as shown in the example of Figure 3E ) or other valves 61 that can operate between a closed state 68 and an open state 69 to unidirectionally regulate the fluid flow 8 within a preselected range.

[0108] 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.

[0109] Now the main reference Figure 5 , Figure 6 as well as Figures 11A to 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.

[0110] 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.

[0111] Again, the main reference Figure 5 ,Figure 6 and Figures 11A to 12D As for the specific implementation, 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. Both the second valve pressure relief element 71 and the third valve pressure relief element 72 can be manually operable to respectively generate fluid flows 8 in the second fluid flow conduit 55 and the third fluid flow conduit 57.

[0112] Now mainly referring to Figures 11A to 12D As for the specific implementation, the ear canal pressure regulating device 1 can be configured to achieve an ear canal pressure 10 that can be less than or greater than the ambient pressure 11. An effective amount of the ear canal pressure 10 for relieving the symptoms of one or more disorders or treating one or more disorders, or the maximum amount of the ear canal pressure 10 in the pressure regulation profile 73 generated by the implementation of the ear 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 ear canal pressure 10 at which the user 23 may experience discomfort or the ear canal 24 or the eardrum 25 may be damaged. Although the allowable authority of the ear canal pressure 10 that may cause discomfort to the user 23 or damage to the ear canal 24 or the eardrum 25 varies, generally, the implementation of the ear 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.

[0113] Now mainly referring to Figure 2A 、 Figure 5 and Figures 11A to 11D As for the specific implementation, the ear canal pressure regulating device 1 can be configured to achieve an ear canal pressure 10 that may be greater than the ambient pressure 11. Thus, the valved conduit 5 can be coupled in a first configuration 45 to the fluid flow generator 2 and the axial earpiece aperture 4 of the earpiece 3 to unidirectionally regulate the fluid flow 8 in a first direction 47 in the first fluid flow conduit 5, thereby discharging to the ear canal 6 from the axial earpiece aperture 4.

[0114] As Figure 11A and Figure 11BAs shown, the outer earpiece surface 7 of the earpiece 3 can be sealingly engaged with the aforementioned ear canal 6. The operating fluid flow generator 2 can compress the fluid volume 74 in the first portion 53 of the first fluid flow conduit 49. For these embodiments including the volume adjustable element 13, the elastic flexible wall 16 can deform to reduce the internal volume 19 of the volume adjustable element 13 to compress the fluid volume 74 in the first portion 53 of the first fluid flow conduit 49, resulting in a pressure difference 9 existing between opposite sides of the first valve 52 and the second valve 56. For these embodiments including the piston 27 reciprocatingly operating in the cylinder 28, the piston 27 can travel within the cylinder 28 to reduce the internal volume of the cylinder, thereby resulting in a pressure difference 9 existing between opposite sides of the first valve 52 and the second valve 56. Irrespective of the construction of the fluid flow generator 2, the pressure difference 9 between 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 difference 9 may be sufficient to generate the open state 69 of the first valve 52. The pressure difference 9 between opposite sides of the second valve 56 can cause the fluid pressure 75 in the first portion 53 of the first fluid flow conduit 49 to be greater than the ambient pressure 11, which may be sufficient to generate the 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 can result in a fluid flow 8 in the first fluid flow conduit 49 in the first direction 47, with the fluid flow 8 flowing from the fluid flow generator 2 through the axial earpiece aperture 4 to be discharged into the ear canal 6 from the second earpiece end 29, thereby increasing the ear canal pressure 10 to be greater than the ambient pressure 11.

[0115] As Figure 11C shown, continuing to operate the fluid flow generator 2 can further act to reduce the pressure difference 9 between opposite sides of the first valve 52 and the second valve 56, for example, by allowing the elastic flexible wall 16 of the volume adjustable element 13 to return to the non-deformed state 21. The pressure difference 9 between 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 less than the fluid pressure 75 in the second portion 54 of the first fluid flow conduit 49. This pressure difference 9 may be sufficient to generate the 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 aperture 4 towards the fluid flow generator 2, thus correspondingly maintaining the pressure difference 9 between the ear canal pressure 10 and the ambient pressure 11.

[0116] Referring again to Figure 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.

[0117] Now refer to Figure 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.

[0118] Now the main reference Figure 5 and Figure 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.

[0119] Now the main reference Figure 2B , Figure 6 as well as Figures 12A to 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.

[0120] like Figure 12A and Figure 12BAs shown, the outer earpiece surface 7 of the earpiece 3 can be sealingly engaged with the aforementioned ear canal 6. The operating fluid flow generator 2 can compress the fluid volume 74 in the first portion 53 of the first fluid flow conduit 49. For these embodiments including the volume adjustable element 13, the resilient flexible wall 16 can be deformed to reduce the internal volume 19 of the volume adjustable element 13 to compress the fluid volume 74 in the first portion 53 of the first fluid flow conduit 49, resulting in a pressure difference 9 existing between opposite sides of the first valve 52 and the second valve 56. For these embodiments including the piston 27 reciprocatingly operating within the cylinder 28, the piston 27 can travel within the cylinder 28 to reduce the internal volume of the cylinder, thereby resulting in a pressure difference 9 existing between opposite sides of the first valve 52 and the second valve 56. Irrespective of the construction of the fluid flow generator 2, the pressure difference 9 between 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 difference 9 may be sufficient to generate the closed state 68 of the first valve 52. The pressure difference 9 between opposite sides of the second valve 56 can cause the fluid pressure 75 in the first portion 53 of the first fluid flow conduit 49 to be greater than the ambient pressure 11, which may be sufficient to generate the open state 69 of the second valve 56, which can generate a fluid flow 8 in the second fluid flow conduit 55 from the fluid flow generator 2 towards the ambient pressure 11.

[0121] As Figure 12C shown, continuing to operate the fluid flow generator 2 can further act to reduce the pressure difference 9 between opposite sides of the first valve 52 and the second valve 56, for example, by allowing the resilient flexible wall 16 of the volume adjustable element 13 to return to the non-deformed state 21. The pressure difference 9 between 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 less than the fluid pressure 75 in the second portion 54 of the first fluid flow conduit 49. This pressure difference 9 may be sufficient to generate the open state 69 of the first valve 52, which can result in a fluid flow 8 from the ear canal 6 towards the fluid flow generator 2, thereby reducing the ear canal pressure 10 to be less than the ambient pressure 11.

[0122] Referring again Figure 12C , continuing to reduce the fluid pressure 75 within the first portion 53 of the first fluid flow conduit 49 can result in a pressure difference 9 existing 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 is less than the ambient pressure 11, which may be sufficient to generate the 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 towards the ambient pressure 11 and correspondingly maintaining the pressure difference 9 between the ear canal pressure 10 and the ambient pressure 11.

[0123] For these embodiments having the volume adjustable element 13, the fluid flow 8 from the external auditory canal 6 towards the fluid flow generator 2 can allow the resilient flexible wall 16 to return to the non-deformed state 21 by increasing the internal volume 19. For these embodiments having the piston 27 reciprocatingly operating within the barrel 28, the fluid flow 8 from the external auditory canal 6 towards 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 barrel internal volume.

[0124] Now referring primarily to Figure 12D , the third valve 58 in the closed state 68 can be substantially leak-proof to the fluid flow 8 in the third fluid flow conduit 57 at differential pressure amplitudes 59 of up to about 50 kilopascals between the external auditory canal pressure 10 and the ambient pressure 11. Thus, the external auditory canal pressure regulating 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, beyond which will cause the opening state 69 of the third valve 58, allowing fluid flow 8 from the ambient pressure 11 towards the external auditory canal 6 to maintain the desired or preselected external auditory canal pressure 10.

[0125] Now referring mainly to Figure 6 and Figure 12D , the third valve 58 can be operatively coupled to a third valve pressure relief element 72, which is configured to allow manual operation of the third valve 58 between the closed state 68 and the open state 69 to facilitate the restoration of the external auditory canal pressure 10 to the ambient pressure 11.

[0126] Now referring mainly to Figures 13A to 13F , a particular embodiment of the external auditory canal pressure regulating device 1 can include a fluid flow generator 2 configured as a diaphragm 15 having a resilient flexible wall 16 with 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 the valved conduit 5). The resilient flexible wall 16 in the deformed state 20 can decrease the internal volume 19 and, conversely, towards the 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 aperture 4 of the earpiece 3 that can be regulated by the valved conduit 5.

[0127] Again referring primarily to Figures 13A to 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.

[0128] 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.

[0129] 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 (having an opposing configuration) Figure 3B as well as Figures 13C to 13F ).

[0130] As for the specific implementation manner, the second valve assembly 84 can be operated to allow the external ear canal pressure 10 to recover 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 a deformation member 86 configured to be able to deform the elastically deformable annular member 85. The elastically deformable annular member 85 can have an outer annular surface 87, and the outer annular surface 87 can be arranged adjacent to and sealingly engageable with the inner surface 88 of the first fluid flow conduit 49.

[0131] An annular member hole element 89 communicating between the inner annular surface 90 and the outer annular surface 87 of the annular member can be aligned with the axial earphone hole 4 to form a through connection 91 between the first fluid flow conduit 49 and the axial earphone hole 4. The deformation member 86 can be arranged to pass through a third fluid flow conduit 57 communicating between the first fluid flow conduit 49 and the ambient pressure 11, such that a first end 92 of the deformation member can extend outward from the third fluid flow conduit 57 and the conduit body 41, and a second end 93 of the deformation member can be deformably engaged with the outer annular surface 87 of the annular member. When the first end 92 of the deformation member is grasped and engaged, the deformation member 86 can be pushed toward the elastically deformable annular member 85 to deform the elastically deformable annular member 85, such that the outer annular surface 87 disengages from the 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 earphone hole 4, the first fluid flow conduit 49, 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 ear canal 6 and the ambient pressure 11 to allow the external ear canal pressure 10 to recover to the ambient pressure 11, regardless of whether the external ear canal pressure 10 is greater than the ambient pressure 11 or the external ear canal pressure 10 is less than the ambient pressure 11.

[0132] The fluid flow generator 2, the first valve assembly 83 and the second valve assembly 84 can be detachably 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 a sufficiently similar structure to allow the conduit body 41 to be detachably 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 that the external ear canal pressure 10 is greater than the ambient pressure 11 (as Figure 13E shown in the example) or whether the valved conduit 5 is operated to achieve a pressure difference 9 such that the external ear canal pressure 10 is less than the ambient pressure 11 (as Figure 13Fas shown in the example of). As for the specific implementation, in order to be detachably coupled, the releasable coupling surface 44 of the pipe body 41, the fluid flow generator 2, the first valve assembly 83, and the second valve assembly 84 can be cooperatively engaged.

[0133] Regarding the specific implementation of the external auditory canal pressure regulating device 1 described herein, the first valve 52 and the second valve 56 are fluidly coupled to the corresponding first fluid flow pipe 49 and second fluid flow pipe 55 to interrupt the fluid flow 8 in the corresponding first fluid flow pipe 49 and second fluid flow pipe 55, regardless of whether the pipe body 41 may be positioned in the first configuration 45 or may be positioned in the second configuration 46.

[0134] Now mainly referring to Figure 13E , as an illustrative example, the fluid flow generator 2, the first valve assembly 83, and the pipe body 41 can be positioned in the first configuration 45 by detachably coupling the fluid flow generator 2 and the first valve assembly 83 to the pipe 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 pipe 49. Thus, 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 earphone hole 4, and in the closed state 68 prevents the fluid flow 8 from flowing between the fluid flow generator 2 and the axial earphone hole 4. Therefore, to reduce the internal volume 19, the fluid flow 8 generated by deforming the elastic flexible wall 16 of the diaphragm 15 can be regulated in the first fluid flow pipe 49 in the first direction 47 to be discharged from the axial earphone hole 4 to the external auditory canal 6, thereby achieving a pressure difference 9 between the external auditory canal pressure 10 and the ambient pressure 11. When achieving the desired pressure difference 9 between the external auditory canal pressure 10 and the ambient pressure 11, the elastic flexible wall 16 of the diaphragm 15 can allow a return to the non-deformed state 21, thereby closing the first valve 52 and preventing the fluid flow 8 from flowing from the axial earphone hole 4 to the fluid flow generator 2, thereby maintaining the desired pressure difference 9.

[0135] In the first configuration 45, the second valve 56 can be operated to unidirectionally regulate the fluid flow 8 in the second fluid flow pipe 55. Thus, 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.

[0136] Therefore, to increase the internal volume 19, the fluid flow 8 generated when the elastic flexible wall 16 of the diaphragm 15 returns to the non-deformed state 21 can be regulated in the second fluid flow pipe 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.

[0137] Regarding the specific implementation, the fluid flow generator 2, the first valve assembly 83, and the pipe body 41 in the first configuration 45 may further include a second valve assembly 84. The second valve assembly 84 is positioned such that the third valve 58 can be fluidly connected to a third fluid flow pipe 57 that communicates between the first fluid flow pipe 49 and the ambient pressure 11 to unidirectionally regulate the fluid flow 8 in the third fluid flow pipe 57 between the first fluid flow pipe 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 earphone hole 4 through the first fluid flow pipe 49 and the third fluid flow pipe 57 and towards the ambient pressure 11, and blocks the fluid flow 8 from flowing between the axial earphone hole 4 and the ambient pressure 11 in the closed state 68. Therefore, the third valve 58 in the open state 69 can generate a fluid flow 8 from the external auditory canal 6 towards the ambient pressure 11 to restore the external auditory canal pressure 10 to the ambient pressure 11.

[0138] Regarding the specific implementation, 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 change to reverse the orientation of the first valve assembly 83 relative to the pipe body 41, thereby implementing the second configuration 46.

[0139] Now mainly referring to Figure 13F , as an illustrative example, the fluid flow generator 2, the first valve assembly 83, and the pipe 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 pipe 55. Thus, the second valve 56 in the open state 69 allows the fluid flow 8 to flow from the fluid flow generator 2 towards the ambient pressure 11, and blocks the fluid flow 8 from flowing between the fluid flow generator 2 and the ambient pressure 11 in the closed state 68. Therefore, to reduce the internal volume 19, the fluid flow 8 generated by deforming the elastic flexible wall 16 of the diaphragm 15 can be regulated in the second fluid flow pipe 55 to be discharged from the second fluid flow pipe 55 towards the ambient pressure 11. The elastic flexible wall 16 of the diaphragm 15 can allow a return to the undeformed state 21, thereby closing the second valve 56 and blocking the fluid flow 8 from flowing between the fluid flow generator 2 and the ambient pressure 11.

[0140] In the second configuration 46, the first valve 52 can be operated to unidirectionally regulate the fluid flow 8 in the first fluid flow pipe 49. Thus, the first valve 52 in the open state 69 allows the fluid flow 8 to flow from the axial earphone hole 4 towards the fluid flow generator 2, and blocks the fluid flow 8 from flowing between the axial earphone hole 4 and the fluid flow generator 2 in the closed state 68.

[0141] Therefore, to increase the internal volume 19, the fluid flow 8 generated when returning the elastic flexible wall 16 of the diaphragm 15 to the undeformed state 21 can be adjusted in the second direction 48 in the first fluid flow conduit 56 to enter the axial earpiece aperture 4 from the ear canal 6 towards the fluid flow generator 2, thereby achieving a pressure difference 9 such that the ear canal pressure 10 is less than the ambient pressure 11. When the desired pressure difference 9 between the ear canal pressure 10 and the ambient pressure 11 is achieved, the first valve 52 can return to the closed state 68, preventing the fluid flow 8 from flowing between the axial earpiece aperture 4 and the fluid flow generator 2, thereby maintaining the desired pressure difference 9 between the ear canal pressure 10 and the ambient pressure 11.

[0142] As for the specific implementation, 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. The second valve assembly 84 is positioned such that the third valve 58 can be fluidly coupled to a third fluid flow conduit 57 that communicates 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 towards the axial earpiece aperture 4, and blocks the fluid flow 8 from flowing between the ambient pressure 11 and the axial earpiece aperture 4 in the closed state 68. Therefore, the third valve 58 in the open state 69 can generate a fluid flow 8 from the ambient pressure 11 towards the ear canal 6 to restore the ear canal pressure 10 to the ambient pressure 11.

[0143] Now mainly referring to Figures 14A to 15G , which shows the pressure difference 9 between the ear canal pressure 10 and the ambient pressure 11 achieved during the time period 76 by operating the ear canal pressure regulating device 1. As for the specific implementation, the fluid flow generator 2 including the volume adjustable element 13 can be operated from the undeformed state 21 towards the deformed state 20 to generate a fluid flow 8 in the first direction 47, discharging the fluid flow 8 from the axial earpiece aperture 4 to the ear canal 6 during the time period 76, resulting in a positive ear canal pressure 10 relative to the ambient pressure 11 (as shown in the example of Figures 14A to 14G ). As for other specific implementations, the fluid flow generator 2 including the volume adjustable element 13 can be operated from the deformed state 20 towards the undeformed state 21 to generate a fluid flow 8 in the second direction 48, with the fluid flow 8 entering the axial earpiece aperture 4 from the ear canal 6 towards the fluid flow generator 2 during the time period 76, resulting in a negative ear canal pressure 10 relative to the ambient pressure 11 (as shown in the example of Figures 15A to 15G ).

[0144] Now mainly referring to Figures 14A to 15A, the fluid flow generator 2 can be operated to maintain a constant pressure amplitude 77 during a period 76. As for a specific implementation, the constant pressure amplitude 77 can be maintained during the period 76 such that there is substantially no fluid flow 8 of the fluid volume 12 within the external auditory canal 6. As an illustrative example, the external auditory canal pressure regulating device 1 having the earphone outer surface 7 that can be sealingly 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 earphone hole 4 of the earphone 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 period 76, for example, by operating the first valve 52, without an additional fluid flow 8 of the fluid volume 12. The first valve 52 is configured to allow a one-way fluid flow 8 of the fluid volume 12 through the first fluid flow conduit 49 such that the fluid volume 12 can only enter or exit from the external auditory canal 6. As for other implementations, 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 period 76 by an additional fluid flow 8 of the fluid volume 12 entering or exiting the external auditory canal 6 to counteract leakage regarding the engagement of the earphone outer surface 7 with the external auditory canal 6. As for other implementations, the pressure amplitude 77 can be maintained during the period 76 by a continuous fluid flow 8 of the fluid volume 12 within the external auditory canal 6.

[0145] A constant pressure amplitude 77 can be maintained during the period 76 to relieve symptoms of a disorder or treat a disorder, whereby the constant pressure amplitude 77 can be in a range between about +50 kPa above the ambient pressure 11 and about -50 kPa below the ambient pressure 11. A positive external auditory canal pressure 10 relative to the ambient pressure 11 can be achieved by maintaining the constant pressure amplitude 77 in a range between about 0 kPa and about +50 kPa above the ambient pressure 11. Alternatively, a negative external auditory canal pressure 10 relative to the ambient pressure 11 can be achieved by maintaining the constant pressure amplitude 77 in a range between about -50 kPa and about 0 kPa below the ambient pressure 11.

[0146] Now mainly referring to Figures 14B to 14G and Figures 15B to 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 implementation, the fluid flow generator 2 including the volume adjustable element 13 can be operated from a non-deformed state 21 towards a deformed state 20 to generate a fluid flow 8 that is discharged from the axial earphone hole 4 to the external auditory canal 6 during the period 76. Thereby, 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 (as Figures 14B to 14Gas shown in the example of). For other specific embodiments, the fluid flow generator 2 including the volume adjustable element 13 can be operated from a deformed state 20 towards an undeformed state 21 to generate a fluid flow 8 towards the fluid flow generator 2 from the external auditory canal 6 into the axial earpiece aperture 4 during 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 (as Figures 15B to 15G as shown in the example of).

[0147] Referring again primarily to Figures 14A to 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 generally in the range between 0 hertz and about 10 hertz; however, depending on the application, the embodiment can have a smaller or larger pressure wave frequency 79. For a specific embodiment, one or more pressure wave frequencies 79 can be selected from the group consisting of or comprising the following: between 0 hertz and about 1 hertz, between about 0.5 hertz and about 1.5 hertz, between about 1 hertz and about 2 hertz, between about 1.5 hertz and about 2.5 hertz, between about 2 hertz and about 3 hertz, between about 2.5 hertz and about 3.5 hertz, between about 3 hertz and about 4 hertz, between about 3.5 hertz and about 4.5 hertz, between about 4 hertz and about 5 hertz, between about 4.5 hertz and about 5.5 hertz, between about 5 hertz and about 6 hertz, between about 5.5 hertz and about 6.5 hertz, between about 6 hertz and about 7 hertz, between about 6.5 hertz and about 7.5 hertz, between about 7 hertz and about 8 hertz, between about 7.5 hertz and about 8.5 hertz, between about 8 hertz and about 9 hertz, between about 8.5 hertz and about 9.5 hertz, and between about 9 hertz and about 10 hertz.

[0148] Depending on the method of use, one or more pressure wave frequencies 79 can be generated with the external auditory canal pressure regulating device 1, possibly further affected by factors such as the user 23's anatomy, the physiology or biochemistry of the auditory canal 24; the symptoms of the condition to be alleviated; the condition to be treated; the effects observable in a specific method of using the external auditory canal pressure regulating device 1 with one or more pressure wave frequencies 79; 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 eardrum 25.

[0149] The pressure wave 78 can oscillate only with a positive pressure amplitude 77 within a range of between 110 kPa above the ambient pressure to about +50 kPa with a desired pressure wave frequency 79 as Figures 14B to 14GAs shown in the example of Figures 15B to 15G , this can be achieved by generating 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, alleviating the symptoms of a disorder or treating a disorder. For other specific embodiments, the pressure wave 78 can oscillate only at the desired pressure wave frequency 79 within the negative pressure amplitude 77 (in the range between about -50 kPa and 0 kPa below the ambient pressure 11) (as shown in the example of Figures 15B to 15G ), this can be achieved by generating a negative external auditory canal pressure 10 relative to the ambient pressure 11 by decreasing the external auditory canal pressure 10 relative to the ambient pressure 11, for example, alleviating the symptoms of a disorder or treating a disorder.

[0150] Referring again primarily to Figures 14B to 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 disorders 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 a smooth repeating periodic oscillation (as shown in the examples of Figure 14B and Figure 15B ), a square wave, a rectangular wave, a trapezoidal wave that alternates the pressure amplitude 77 between a fixed minimum and maximum value at a stable frequency, or a truncated wave that has a constant pressure amplitude 77 at the apex of the pressure wave 78 within the time period 76 (as shown in the examples of Figure 14C , Figure 15C , Figure 14F and Figure 15F ), a triangular wave with linear leading and trailing edges (as shown in the examples of Figure 14D and Figure 15D ), a sawtooth wave that changes the pressure amplitude 77 at the leading edge within a time period 76 that is greater than the time period 76 during which the trailing edge changes the pressure amplitude 77 (as shown in the example of Figure 14E ), a reverse sawtooth wave that changes the pressure amplitude 77 at the leading edge within a time period 76 that is less than the time period 76 during which the trailing edge changes the pressure amplitude 77 (as shown in the example of Figure 15E ), or a combination thereof (as shown in the examples of Figure 14G and Figure 15G ).

[0151] For a specific embodiment, the fluid flow generator 2 and the third valve pressure relief element 72 coupled to the third valve 58 can be alternately and repeatedly operated to generate a fluid flow 8 having a pressure wave 78 including a pressure wave amplitude 77 and a pressure wave frequency 79.

[0152] Now referring primarily to Figures 14A to 14G , which shows the pressure difference 9 between the external auditory canal pressure 10 and the ambient pressure 11 achieved within the time period 76 by operating an embodiment of the external auditory canal pressure regulating device 1 to generate a positive external auditory canal pressure 10 relative to the ambient pressure 11 (as shown in the examples of Figure 2A ,Figure 5 and Figures 11A to 11D As shown in the example of Figures 11A to 11D . The specific implementation of the external ear canal pressure regulating device 1 includes a third valve 58, and the third valve 58 is substantially leak-proof to the fluid flow 8 in the third fluid flow pipe 57 when the pressure difference amplitude 59 between the external ear canal pressure 10 and the ambient pressure 11 is up to about 50 kPa (represented as the pressure amplitude 77 being zero in each curve graph). However, this does not necessarily limit the implementation to those that can generate a positive external ear canal pressure 10 preselected up to a maximum of +50 kPa relative to the ambient pressure 11. Other implementations can be operated to generate a positive external ear canal pressure 10 that can be any amount greater than the ambient pressure 11 relative to the ambient pressure 11, but the amount is not so large as to cause discomfort to the user 23 or damage to the ear canal 24 or the eardrum 25.

[0153] Now mainly referring to Figure 14A , as for the specific implementation, the fluid flow generator 2 can be operated to generate an external ear canal pressure 10 with a maximum pressure amplitude 77 that is up to about +50 kPa higher than the ambient pressure 11. The external ear canal pressure 10 can be maintained at about +50 kPa higher than 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 ear canal pressure 10 to the ambient pressure 11. The operation can be repeated, but not necessarily.

[0154] Now mainly referring to Figure 14B , as for the specific implementation, the fluid flow generator 2 can be operated to generate an external ear canal pressure 10 with a maximum pressure amplitude 77 that is up to about +50 kPa higher than the ambient pressure 11. The third valve pressure relief element 72 can be operated to restore the external ear canal pressure 10 to the ambient pressure 11, whereby the pressure wave 78 can be a sine wave with a smooth repeating periodic oscillation. The operation can be repeated to apply a pulsating change in the external ear canal pressure 10.

[0155] Now mainly referring to Figure 14D , as for the specific implementation, the fluid flow generator 2 can be operated to generate an external ear canal pressure 10 with a maximum pressure amplitude 77 that is up to about +50 kPa higher than the ambient pressure 11. The third valve pressure relief element 72 can be operated to restore the external ear canal pressure 10 to the ambient pressure 11, whereby the pressure wave 78 can be a triangular wave with a linear leading edge and trailing edge. The operation can be repeated to apply a pulsating change in the external ear canal pressure 10.

[0156] Now mainly referring to Figure 14E, As for the specific implementation, the fluid flow generator 2 can be operated to generate an ear canal pressure 10 having a maximum pressure amplitude 77 that is up to about +50 kPa higher than the ambient pressure 11. The third valve pressure relief element 72 can be operated to return the ear canal pressure 10 to the ambient pressure 11, whereby the pressure wave 78 can be a sawtooth wave that changes the leading edge pressure amplitude 77 within a period 76 that is greater than the period 76 that changes the trailing edge pressure amplitude 77. The operation can be repeated to apply a pulsating change in the ear canal pressure 10.

[0157] Now mainly referring to Figure 14C and Figure 14F , As for the specific implementation, the fluid flow generator 2 can be operated to generate an ear canal pressure 10 having a maximum pressure amplitude 77 that is up to about +50 kPa higher than the ambient pressure 11. The ear canal pressure 10 can be maintained at about +50 kPa higher than the ambient pressure 11 for a period 76. After the period 76, the third valve pressure relief element 72 can be operated to return the ear canal pressure 10 to the ambient pressure 11. The operation can be repeated to apply a pulsating change in the ear canal pressure 10.

[0158] Now mainly referring to Figure 14G , As for the specific implementation, the fluid flow generator 2 can be operated to increase the ear canal pressure 10 during a series of incremental pressure increases such that the maximum pressure amplitude 77 is about +50 kPa higher than the ambient pressure 11. Each of the series of incremental pressure increases can increase the ear canal pressure 10 by about 10 kPa to about 15 kPa higher than the ambient pressure 11, with each incremental pressure increase occurring while the ear canal pressure 10 is maintained for a period 76. After achieving a maximum pressure amplitude 77 that is about +50 kPa higher than the ambient pressure 11 and after the period 76, the third valve pressure relief element 72 can be operated to return the ear canal pressure 10 to the ambient pressure 11. The operation can be repeated to apply a pulsating change in the ear canal pressure 10.

[0159] Now mainly referring to Figures 15A to 15G , which shows the pressure difference 9 between the ear canal pressure 10 and the ambient pressure 11 achieved within the period 76 by operating the ear canal pressure regulating device 1 to generate a negative ear canal pressure 10 relative to the ambient pressure 9 (as Figure 2B , Figure 6 and Figures 12A to 12Das shown in the example of). The specific implementation of the external ear canal pressure regulating device 1 includes a third valve 58, and the third valve 58 remains substantially leak-proof for the fluid flow 8 in the third fluid flow pipe 57 when the pressure difference amplitude 59 between the external ear canal pressure 10 and the ambient pressure 11 is up to about 50 kPa (represented as the pressure amplitude 77 being zero in each curve graph). However, this does not necessarily limit the implementation to those that can generate a negative external ear canal pressure 10 with a maximum of -50 kPa relative to the ambient pressure 11. Other implementations can be operated to generate a negative external ear canal pressure 10 that can be any amount less than the ambient pressure 11 relative to the ambient pressure 11, but the amount is not so large as to cause discomfort to the user 23 or damage to the ear canal 24 or the eardrum 25.

[0160] Now mainly referring to Figure 15A , as for the specific implementation, the fluid flow generator 2 can be operated to generate an external ear canal pressure 10 with a maximum pressure amplitude 77 that is up to about -50 kPa lower than the ambient pressure 11. The external ear canal pressure 10 can be maintained at about -50 kPa lower than 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 ear canal pressure 10 to the ambient pressure 11. The operation can be repeated, but not necessarily.

[0161] Now mainly referring to Figure 15B , as for the specific implementation, the fluid flow generator 2 can be operated to generate an external ear canal pressure 10 with a maximum pressure amplitude 77 that is up to about -50 kPa lower than the ambient pressure 11. The third valve pressure relief element 72 can be operated to restore the external ear canal pressure 10 to the ambient pressure 11, whereby the pressure wave 78 can be a sine wave with a smooth repetitive periodic oscillation. The operation can be repeated to apply a pulsating change in the external ear canal pressure 10.

[0162] Now mainly referring to Figure 15D , as for the specific implementation, the fluid flow generator 2 can be operated to generate an external ear canal pressure 10 with a maximum pressure amplitude 77 that is up to about -50 kPa lower than the ambient pressure 11. The third valve pressure relief element 72 can be operated to restore the external ear canal pressure 10 to the ambient pressure 11, whereby the pressure wave 78 can be a triangular wave with a linear leading edge and trailing edge. The operation can be repeated to apply a pulsating change in the external ear canal pressure 10.

[0163] Now mainly referring to Figure 15E, Regarding the specific implementation, the fluid flow generator 2 can be operated to generate an external ear canal pressure 10 having a maximum pressure amplitude 77 that is up to about -50 kPa below the ambient pressure 11. The third valve pressure relief element 72 can be operated to restore the external ear canal pressure 10 to the ambient pressure 11. Thus, the pressure wave 78 can be a reverse sawtooth wave that changes the pressure amplitude 77 at the leading edge within a period 76 that is less than the period 76 that changes the pressure amplitude 77 at the trailing edge. The operation can be repeated to apply a pulsating change in the external ear canal pressure 10.

[0164] Now mainly referring to Figure 15C and Figure 15F , Regarding the specific implementation, the fluid flow generator 2 can be operated to generate an external ear canal pressure 10 having a maximum pressure amplitude 77 that is up to about -50 kPa below the ambient pressure 11. The external ear canal pressure 10 can be maintained at about -50 kPa below the ambient pressure 11 for a period 76. After the period 76 has elapsed, the third valve pressure relief element 72 can be operated to restore the external ear canal pressure 10 to the ambient pressure 11. The operation can be repeated to apply a pulsating change in the external ear canal pressure 10.

[0165] Now mainly referring to Figure 15G , Regarding the specific implementation, the fluid flow generator 2 can be operated to decrease the external ear canal pressure 10 during a series of incremental pressure decreases, such that the maximum pressure amplitude 77 is about -50 kPa below the ambient pressure 11. Each of the series of incremental pressure decreases can decrease the external ear canal pressure 10 to about -10 kPa to about -15 kPa below the ambient pressure 11, with each incremental pressure decrease occurring while the external ear canal pressure 10 is maintained for a period 76. After achieving a maximum pressure amplitude 77 that is about -50 kPa below the ambient pressure 11 and after the period 76 has elapsed, the third valve pressure relief element 72 can be operated to restore the external ear canal pressure 10 to the ambient pressure 11. The operation can be repeated to apply a pulsating change in the external ear canal pressure 10.

[0166] Regarding the specific implementation, the external ear canal pressure regulating device 1 can further include a housing 80 having an inner housing surface that defines a generally hollow inner space within which the components of the external ear canal pressure regulating device 1 can be accommodated. Regarding the specific implementation, the housing 80 can be configured to fill all or part of the outer ear region 82 of the ear 35 and not extend any significant distance beyond the outer side of the external auditory canal 24, thereby providing a discrete, unobtrusive, portable configuration that can be used when alleviating the symptoms of one or more disorders (such as neurologically mediated pain) or treating one or more disorders (such as craniofacial pain symptoms or headache symptoms).

[0167] Although the fluid flow generator 2 of the above-described external ear canal pressure regulating device 1 generally delivers a fluid stream 8 of air to the external ear canal 6 to achieve a pressure difference 9 between the external ear canal pressure 10 and the ambient pressure 11, this is not intended to limit the various fluids that can be delivered to the external ear canal 6 by the external ear canal pressure regulating device 1. As illustrative examples, the various fluids can 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.

[0168] In addition, although the transfer of the fluid stream 8, or the fluid volume 12, between the components of the external ear canal pressure regulating device 1, between the components of the external ear canal pressure regulating device 1 and the external ear canal 6, or between the components of the external ear canal pressure regulating device 1 and the ambient pressure 11 can generally be between a first point and a second point as described above for the sake of brevity, the transfer of the fluid stream 8 or the fluid volume 12 includes all points within the manifold fluid flow path 62 between the first point and the second point. For example, the fluid volume 12 transferred from the fluid flow generator 2 to the external ear canal 6 can travel along the fluid flow path 62, which includes the fluid flow generator 2, the first end 50 of the first fluid flow conduit, 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 second end 51 of the first fluid flow conduit, the first end 31 of the earpiece, the axial earpiece aperture 4, the second end 29 of the earpiece, and the external ear canal 6.

[0169] A method for manufacturing a specific embodiment of the external ear canal pressure regulating device 1 can include: providing a fluid flow generator 2 capable of generating a fluid stream 8; providing a valved conduit 5 capable of being fluidly coupled to the fluid flow generator 2, the valved conduit 5 having a first fluid flow conduit 49; providing a first valve 52 capable of interrupting the first fluid flow conduit 49 to unidirectionally regulate the fluid stream 8 in the first fluid flow conduit 49; and providing an axial earpiece aperture 4 that communicates between the first end 31 and the second end 32 of the earpiece 3, the axial earpiece aperture 4 capable of being fluidly coupled to the valved conduit 5 opposite the fluid flow generator 2, the earpiece 3 having a compatible earpiece outer surface 7 configured to sealingly engage the external ear canal 6 as a barrier between the external ear canal pressure 10 and the ambient pressure 11.

[0170] 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.

[0171] 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.

[0172] 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.

[0173] The method of the specific implementation for manufacturing the external ear canal pressure regulating device 1 may further include: providing a fluid flow generator 2 configured with a volume adjustable element 13 having an internal volume 19, the volume adjustable element 13 having a deformed state 20 that reduces the internal volume 19 to generate the fluid flow 8 in the first fluid flow conduit 49, and a first valve 52 unidirectionally regulating the fluid flow 8 to discharge from the axial earphone hole 4 of the earphone 3. Regarding the specific implementation, the volume adjustable element 13 may return to an undeformed state 21 that increases the internal volume 19 to generate the fluid flow 8 in the second fluid flow conduit 55, and a second valve 56 unidirectionally regulates the fluid flow 8 to enter from the ambient pressure 11 towards 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 towards the first portion 53.

[0174] The method of the specific implementation for manufacturing the external ear canal pressure regulating device 1 may further include: providing a fluid flow generator 2 configured with a volume adjustable element 13 having an internal volume 19, the volume adjustable element 13 having a deformed state 20 that reduces the internal volume 19 to generate the fluid flow 8 in the second fluid flow conduit 55, and a second valve 52 unidirectionally regulating the fluid flow 8 to discharge from the second fluid flow conduit 55 to the ambient pressure 11. Regarding the specific implementation, the volume adjustable element 13 may return to an undeformed state 21 that increases the internal volume 19 to generate the fluid flow 8 in the first fluid flow conduit 49, and a first valve 52 unidirectionally regulates the fluid flow 8 to enter from the axial earphone hole 4 of the earphone 3 towards 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 towards the first portion 53.

[0175] The method of the specific implementation for manufacturing the external ear canal pressure regulating device 1 may further include: providing a third fluid flow conduit 57 configured to be fluidly connectable between the second portion 54 of the first fluid flow conduit 49 and the ambient pressure 11, and further include: providing a third valve 58 configured to interrupt the third fluid flow conduit 57 to unidirectionally regulate the fluid flow 8 in the third fluid flow conduit 57. Regarding the specific implementation, the method may further include: providing a third valve 58 configured to regulate the fluid flow 8 to discharge to the ambient pressure 11. Regarding other specific implementations, the method of the specific implementation for manufacturing the external ear canal pressure regulating device 1 may further include: providing a third valve 58 configured to regulate the fluid flow 8 to enter from the ambient pressure 11.

[0176] The method of the specific embodiment of manufacturing the external ear canal pressure regulating device 1 may further include: providing a third valve 58 having a structure capable of interrupting the fluid flow 8 between the second part 54 of the first fluid flow conduit 49 and the ambient pressure 11 until the pressure difference 9 between the second part 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 the specific embodiment, the one or more preselected pressure difference amplitudes 59 may be selected from the group consisting of or including: 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, between about 22.5 kPa and about 27.5 kPa, between about 25 kPa and about 30 kPa, between about 27.5 kPa and about 32.5 kPa, between about 30 kPa and about 35 kPa, between about 32.5 kPa and about 37.5 kPa, between about 35 kPa and about 40 kPa, between about 37.5 kPa and about 42.5 kPa, between about 40 kPa and about 45 kPa, between about 42.5 kPa and about 47.5 kPa, and between about 45 kPa and about 50 kPa.

[0177] The method of the specific embodiment of manufacturing the external ear canal pressure regulating device 1 may further include: providing a second valve pressure relief element 71 having a structure capable of being coupled to the second valve 56 and a third valve pressure relief element 72 having a structure capable of being coupled 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.

[0178] The method of the specific embodiment of manufacturing the external ear canal pressure regulating device 1 may further include: providing a valve duct 5 having a structure 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 fluid flow conduit 49 in a first direction 47 and discharge it from the axial earpiece hole 4 of the earpiece 3. As for the specific embodiment, the method may further include: providing a fluid flow generator 2 of a volume adjustable element 13 configured to be operable from a non-deformed state 21 towards a deformed state 20 to generate the fluid flow 2 discharged from the axial earpiece hole 4 within a time period 76.

[0179] The method of the specific embodiment of manufacturing the external auditory canal pressure regulating device 1 may further include: providing a fluid flow generator 2 having a configuration capable of repeatedly operating from the non-deformed state 21 towards 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 the specific embodiment, the pressure wave frequency 79 may be in the range between 0 Hertz and about 10 Hertz. As for the specific embodiment, one or more pressure wave frequencies 79 may be selected from the group consisting of or including: between 0 Hertz and about 1 Hertz, between about 0.5 Hertz and about 1.5 Hertz, between about 1 Hertz and about 2 Hertz, between about 1.5 Hertz and about 2.5 Hertz, between about 2 Hertz and about 3 Hertz, between about 2.5 Hertz and about 3.5 Hertz, between about 3 Hertz and about 4 Hertz, between about 3.5 Hertz and about 4.5 Hertz, between about 4 Hertz and about 5 Hertz, between about 4.5 Hertz and about 5.5 Hertz, between about 5 Hertz and about 6 Hertz, between about 5.5 Hertz and about 6.5 Hertz, between about 6 Hertz and about 7 Hertz, between about 6.5 Hertz and about 7.5 Hertz, between about 7 Hertz and about 8 Hertz, between about 7.5 Hertz and about 8.5 Hertz, between about 8 Hertz and about 9 Hertz, between about 8.5 Hertz and about 9.5 Hertz, and between about 9 Hertz and about 10 Hertz.

[0180] The method of the specific embodiment of manufacturing the external auditory canal pressure regulating device 1 may further include: providing a third valve pressure relief element 72 having a configuration 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 alternately 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.

[0181] The method of the specific embodiment of manufacturing the external auditory canal pressure regulating device 1 may further include: providing a valve-equipped pipe 5 having a configuration capable of being connected to the fluid flow generator 2 and the earphone 3 in a second configuration 46 to unidirectionally regulate the fluid flow 8 in a second direction 48 in the first fluid flow pipe 49 and enter the axial earphone hole 4 of the earphone 3. As for the specific embodiment, the method may further include: providing a fluid flow generator 2 of a volume adjustable element 13 configured to be operable from the deformed state 20 towards the non-deformed state 21 to generate the fluid flow 2 entering from the axial earphone hole 4 within a time period 76.

[0182] The method of the specific implementation for producing the external auditory canal pressure regulating device 1 may further include: providing a fluid flow generator 2 having a configuration capable of repeatedly operating from the deformed state 20 towards the non-deformed state 21 to generate the fluid flow 8 having the pressure wave 78 including the pressure wave amplitude 77 and the pressure wave frequency 79. As for the specific implementation, the pressure wave frequency 79 may be in the range between 0 Hertz and about 10 Hertz. As for the specific implementation, one or more pressure wave frequencies 79 may be selected from the group consisting of or including: between 0 Hertz and about 1 Hertz, between about 0.5 Hertz and about 1.5 Hertz, between about 1 Hertz and about 2 Hertz, between about 1.5 Hertz and about 2.5 Hertz, between about 2 Hertz and about 3 Hertz, between about 2.5 Hertz and about 3.5 Hertz, between about 3 Hertz and about 4 Hertz, between about 3.5 Hertz and about 4.5 Hertz, between about 4 Hertz and about 5 Hertz, between about 4.5 Hertz and about 5.5 Hertz, between about 5 Hertz and about 6 Hertz, between about 5.5 Hertz and about 6.5 Hertz, between about 6 Hertz and about 7 Hertz, between about 6.5 Hertz and about 7.5 Hertz, between about 7 Hertz and about 8 Hertz, between about 7.5 Hertz and about 8.5 Hertz, between about 8 Hertz and about 9 Hertz, between about 8.5 Hertz and about 9.5 Hertz, and between about 9 Hertz and about 10 Hertz.

[0183] The method of the specific implementation for producing the external auditory canal pressure regulating device 1 may further include: providing a third valve pressure relief element 72 having a configuration capable of being coupled to the third valve 56, whereby the fluid flow generator 2 and the third valve pressure relief element 72 may be capable of alternately 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.

[0184] As for the specific implementation, the components of the external auditory canal pressure regulating device 1 may be formed entirely of the same material, or alternatively, the various components of the external auditory canal pressure regulating device 1 may be formed of different materials. In addition, as for the specific implementation, depending on the application, the external auditory canal pressure regulating device 1 or the components of the external auditory canal pressure regulating device 1 may 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 a single piece or assembled from multiple pieces into an implementation of the external auditory canal pressure regulating device 1 or provided as multiple pieces configured to be assembled into an implementation of the external auditory canal pressure regulating device 1.

[0185] The components of the external auditory canal pressure regulating device 1 can be produced from any of a wide variety of materials that can provide embodiments of the external auditory canal pressure regulating device 1 useful for generating and regulating fluid flow 1. By way of non-limiting example, the valved conduit 1 can be produced from a wide variety of elastomeric compounds, plastics, plastic-like materials, acrylics, polyamides, polyesters, polypropylenes, polyvinyl chloride-based materials, silicone-based materials, etc., or combinations thereof.

[0186] A method of using a particular embodiment of the external auditory canal pressure regulating device 1 can include: obtaining an external auditory canal pressure regulating device 1, the external auditory canal pressure regulating device 1 including a fluid flow generator 2 that generates a fluid flow; a valved conduit 5 fluidly 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 a handset 3 having an axial handset bore 4 that communicates between a first handset end 31 and a second handset end 29, the axial handset bore 4 being fluidly coupled to the valved conduit 5 opposite the fluid flow generator 2, the handset 3 having a compatible handset outer surface 7 configured to sealingly engage the external auditory canal 6 to serve as a barrier between the external auditory canal pressure 10 and the ambient pressure 11; sealingly engaging the handset outer surface 7 of the handset 3 with the external auditory canal 6; generating the fluid flow 8 between the fluid flow generator 2 and the axial handset bore 4; and regulating the pressure differential 9 between the external auditory canal pressure 10 and the ambient pressure 11.

[0187] Regarding a specific implementation manner, a method of using the external ear canal pressure regulating device 1 may include: obtaining the external ear canal pressure regulating device 1, the external ear canal pressure regulating device 1 including a fluid flow generator 2 that generates a fluid flow 8; a valve-equipped pipe 5 having a first fluid flow pipe 49 that can be interrupted by a first valve 52 to unidirectionally regulate the fluid flow 8 in the first fluid flow pipe 49; and a receiver 3 having an axial receiver hole 4 communicating between a first receiver end 31 and a second receiver end 29, the receiver 3 having a compatible receiver outer surface 7 configured to sealingly engage the external ear canal 6 to serve as a barrier between the external ear canal pressure 10 and the ambient pressure 11; fluidly coupling the valve-equipped pipe 5 in a first configuration 45 to the fluid flow generator 2 and the axial receiver hole 4 of the receiver 3 to unidirectionally regulate the fluid flow 8 in the first fluid flow pipe 49 in a first direction 47; sealingly engaging the receiver outer surface 7 of the receiver 3 with the external ear canal 6; generating the fluid flow 8 in the first direction 47 in the first fluid flow pipe 49 between the fluid flow generator 2 and the axial receiver hole 4; and regulating the pressure difference 9 between the external ear canal pressure 10 and the ambient pressure 11, wherein the external ear canal pressure 10 is greater than the ambient pressure 11.

[0188] Regarding a specific implementation manner, the method of using the external ear canal pressure regulating device 1 may further include: operating a pressure relief element 70 to generate the fluid flow 8 from the external ear canal 6 toward the ambient pressure 11 to cause the external ear canal pressure 10 to recover to the ambient pressure 11. Regarding a specific implementation manner, the method may further include: disengaging the receiver outer surface 7 of the receiver 3 from the external ear canal 6.

[0189] Regarding a specific implementation manner, the method of using the external ear canal pressure regulating device 1 may further include: disengaging the valve-equipped pipe 5 in the first configuration 45 from the fluid flow generator 2 and the axial receiver hole 4 of the receiver 3.

[0190] As for the specific implementation manners, the method of using the external ear canal pressure regulating device 1 may further include: fluidly coupling the valve-equipped duct 5 in the second configuration 46 to the fluid flow generator 2 and the axial earphone hole 4 of the earphone 3 to unidirectionally regulate the fluid flow 8 in the first fluid flow duct 49 in the second direction 48; sealingly engaging the outer earphone surface 7 of the earphone 3 with the external ear canal 7; generating the fluid flow 8 between the fluid flow generator 2 and the axial earphone hole 4 in the second direction 48 in the first fluid flow duct 49; and regulating the pressure difference 9 between the external ear canal pressure 10 and the ambient pressure 11, wherein the external ear canal pressure 10 is less than the ambient pressure 11.

[0191] As for the specific implementation manners, the method of using the external ear 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 towards the external ear canal 6 to restore the external ear canal pressure 10 to the ambient pressure 11. As for the specific implementation manners, the method may further include: disengaging the outer earphone surface 7 of the earphone 3 from the external ear canal 6.

[0192] As for the specific implementation manners, the method of using the external ear canal pressure regulating device 1 may further include: disengaging the valve-equipped duct 5 in the second configuration 46 from the fluid flow generator 2 and the axial earphone hole 4 of the earphone 3.

[0193] As can be readily understood from the foregoing, the basic concepts of the present invention can be implemented in a variety of ways. The present invention relates to an external ear canal pressure regulating device and numerous and varied embodiments of a method for manufacturing and using such an external ear canal pressure regulating device (including the best mode).

[0194] Therefore, the specific implementation manners or the elements of the present invention disclosed by the description or shown in the drawings or schedules of the present application are not intended to be restrictive, but rather are exemplary of the numerous and varied embodiments generally encompassed by the present invention or equivalents thereof with respect to any specific element thereof. Additionally, the specific description of a single embodiment or element of the present invention may not explicitly describe all possible embodiments or elements; many alternatives are implicitly disclosed by the description and the drawings.

[0195] It should be understood that each element of a device or each step of a method can be described by device terms or method terms. Such terms may be substituted, with the expectation of implicitly broadly covering the rights of the present invention. As an example, it should be understood that all steps of a method can be disclosed as actions, means for taking such actions, or elements causing such actions. Similarly, each element of a device can be disclosed as a physical element or an action promoted by a physical element. As an example, the disclosed "fluid flow" should be understood to include the action of the disclosed "flowing fluid" whether explicitly discussed or not, and conversely effectively discloses the action of the "flowing fluid", and such disclosure should be understood to include the disclosed "fluid flow" and even "means for fluid flow". Such alternative terms for each element or step should be understood to be explicitly included in the description.

[0196] In addition, with respect to each term used, it should be understood that unless the usage in this application is inconsistent with such an interpretation, the definitions in an ordinary dictionary should be understood to be included in the description of each term included in the Random House Webster’s Unabridged Dictionary, Second Edition, each definition being incorporated herein by reference.

[0197] All numerical values herein are assumed to be modified by the term "about" whether or not explicitly indicated. For the purposes of the present invention, a 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. A numerical range detailed by endpoints includes all numerical values falling within this range. A numerical range of one to five includes, for example, the numerical values 1, 1.5, 2, 2.75, 3, 3.80, 4, 5, and so on. It will be further understood that the endpoints of each range are significant relative to the other endpoints and are independent of the other endpoints. When a value is expressed as approximate by the prefix "about", it will be understood that the specific value forms another embodiment. The term "about" generally refers to a range of numerical values that a person of ordinary skill in the art would consider equivalent to the recited numerical value or having the same function or result. Similarly, the prefix "substantially" means to a large extent but not completely the same form, manner, or degree, and a specific element will have a range of configurations that a person of ordinary skill in the art would consider to have the same function or result. When a specific element is expressed as approximate by the prefix "substantially", it will be understood that the specific element forms another embodiment.

[0198] Moreover, for the purposes of the present invention, the term "a" or "an" entity refers to one or more of such entities unless otherwise restricted. Thus, the terms "a" or "an", "one or more", and "at least one" may be used interchangeably herein.

[0199] Accordingly, the Applicant is understood to claim at least: i) the ear canal pressure regulating device disclosed and described herein, ii) the related methods disclosed and described, iii) analogs, equivalents and even implicit variations of each of these devices and methods, iv) these alternative embodiments that accomplish each function shown, disclosed or described, v) these alternative designs and methods that accomplish each function that is implied to be accomplished by the disclosure shown, 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 devices substantially as described above and with reference to any accompanying examples, x) various combinations and permutations of each of the previously disclosed elements.

[0200] The Background section of this patent application provides a statement of the field to which the present invention pertains. This section may also incorporate or include certain U.S. patents, patent applications, publications or information, problems or concerns regarding the state of the art relevant to the development of the present invention and useful for construing the subject matter of the claimed invention. Any U.S. patent, patent application, publication, statement or other information cited or incorporated herein is not intended to be construed, built or taken as an admission of prior art with respect to the present invention.

[0201] The claims (if any) set forth in this specification are hereby incorporated by reference as part of this description of the present invention, and the Applicant expressly reserves the right to use all or a portion of such incorporated content of such claims as additional description to support any or all of the claims or any of their elements or components, and the Applicant further expressly reserves the right to move any part or all of such incorporated content of such claims or any of their elements or components into the claims, and vice versa, as needed to define the subject matter sought to be protected in this application or any subsequent application or continuation, divisional or partial continuation thereof, or to obtain any priority, fee reduction, or to comply with or satisfy the patent laws, regulations or requirements of any country or treaty, and such incorporated content by reference shall survive throughout the pendency of this application (including any subsequent continuation, divisional or partial continuation thereof or any reissue or extension).

[0202] In addition, the claims (if any) set forth in this specification are further intended to describe a limited number of preferred embodiments of the present invention and are not to be construed as the broadest embodiment of the present invention or as an exhaustive listing of the embodiments of the present invention that may be claimed. The Applicant does not waive any right to further modify the claims based on the description set forth above, as any continuation, divisional or partial continuation, etc. application.

Claims

1. An ear canal pressure regulating device for treating migraine, the device comprising: a receiver for insertion into the external ear canal, the receiver being configured to sealingly engage the external ear canal as a barrier between the external ear canal pressure and the ambient pressure so as to maintain a seal between the receiver and the patient's external ear canal with a pressure difference between the external ear canal pressure and the ambient pressure; and a pressure regulator that defines a flow rate of fluid between the receiver and the surrounding environment external to the ear, the flow rate being defined to reduce the pressure difference between the external ear canal pressure and the ambient pressure over a period of time; wherein the pressure difference between the external ear canal pressure and the ambient pressure effectively alleviates the pain of the migraine.

2. The ear canal pressure regulating device according to claim 1, wherein, the receiver comprises: a first end; a second end, the second end being smaller than the first end, wherein a longitudinal axis extends from the first end to the second end; an outer surface that tapers from the first end towards the second end and has a frustoconical shape; a plurality of circumferential ribs located on the outer surface of the receiver, the plurality of circumferential ribs being spaced apart between the first end and the second end of the receiver; and an axial receiver bore that extends along the longitudinal axis between the first end and the second end of the receiver.

3. The ear canal pressure regulating device according to claim 1 or 2, wherein, the external ear canal pressure is higher than the ambient pressure to create the pressure difference.

4. The ear canal pressure regulating device according to claim 1 or 2, wherein, the external ear canal pressure is lower than the ambient pressure to create the pressure difference.

5. The ear canal pressure regulating device according to any one of claims 1 to 4, wherein, the fluid flow through the pressure regulator has a flow rate of about 0.2 milliliters per second to about 20 milliliters per second.

6. The ear canal pressure regulating device according to any one of claims 1 to 5, wherein, the pressure regulator includes one or more valves.

7. The ear canal pressure regulating device according to any one of claims 1 to 6, wherein, the pressure regulator includes a check valve.

8. The ear canal pressure regulating device according to any one of claims 1 to 7, wherein, the pressure regulator includes a manual pressure relief valve.

9. The ear canal pressure regulating device according to any one of claims 1 to 8, wherein, the ear canal pressure regulating device further includes a fluid flow generator for generating a fluid flow to increase the pressure difference between the external ear canal pressure and the ambient pressure.

10. The ear canal pressure regulating device according to any one of claims 1 to 9, wherein, the pressure difference between the external ear canal pressure and the ambient pressure effectively moves the eardrum of the ear, and wherein moving the eardrum triggers mechanoreceptors to generate nerve impulses for alleviating the pain of the migraine.

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