External ear canal pressure adjustment device

Abstract

To provide an external ear canal pressure adjustment device.SOLUTION: An external ear canal pressure adjustment device includes a fluid flow generator, an earphone having an axial direction earphone bore, and a conduit with a valve which is fluid connected to the fluid flow generator and to the axial direction earphone bore, and thereby the earphone is configured to be sealably engaged with the external ear canal as a barrier between the external ear canal pressure and ambient pressure. In one embodiment, the fluid flow generator has a configuration which causes fluid flow having fluid volume within a range 0 milliliter to approximately 20 milliliters. In another embodiment, the fluid volume has fluid volume selected in advance.SELECTED DRAWING: Figure 1B

Description

[Background technology]

[0001] This International Patent Cooperation Treaty patent application is a continuation-in-part of U.S. Non-provisional Patent Application No. 14 / 292,469, filed May 30, 2014, and claims the benefit of U.S. Provisional Patent Application No. 61 / 983,865, filed April 24, 2014, U.S. Provisional Patent Application No. 61 / 863,317, filed August 7, 2013, and U.S. Provisional Patent Application No. 61 / 841,111, filed June 28, 2013, each of which is incorporated herein by reference.

[0002] Pain or discomfort associated with disorders, including neurally mediated disorders such as craniofacial pain syndromes or headache syndromes, can adversely affect the quality of life of affected individuals. In addition to the burden on individuals, chronic neurological conditions can place significant strain on families, employers, and the healthcare system.

[0003] Concomitant symptoms of migraine, such as pain, nausea, aura, photophobia, paresthesia, dizziness, spatial disorientation, and balance disorders, can pose a significant burden to the general population. Epidemiological studies show that in the United States, approximately 18% of women and 6% of men experience frequent migraines, and 2% of the general population suffers from chronic migraines. In addition, people who suffer from chronic migraines or other headaches of similar severity and disability may be at significantly higher risk of depression and suicide attempts. Therefore, it is prudent for clinicians and researchers to continue to seek effective devices and methods for alleviating the symptoms associated with these disorders or treating them.

[0004] Standard pharmaceutical therapies for migraine headaches can generally be prescribed to prevent or alleviate pain. Various medications within these two broad categories offer a wide range of efficacy but can also suffer from a variety of side effects. From an economic perspective, the cost of these medications can be a major source of financial burden for consumers. Furthermore, advanced interventions such as botulinum toxin injections, neuroleptics, neurosurgical alterations, and implanted electrical stimulation devices can significantly increase the costs associated with treatment, while exposing patients to potential changes in their anatomy and physiology and offering no guarantee of safety or permanent symptom relief or disability elimination.

[0005] There is an emerging field of understanding and application in neuroscience that seeks to affect positive physiological changes in the nervous system through non-pharmaceutical and non-surgical applications. The field of "functional neurology" views the human nervous system as a receptor-driven system that can be activated and stimulated in specific ways to bring about adaptive long-term change through the process of neuroplasticity. This approach to neurorehabilitation utilizes various forms and patterns of receptor activation or deactivation to foster positive neurophysiological adaptations within the central nervous system, including, but not necessarily exclusively, the brain, brainstem, and spinal cord, which can foster the physiological function of associated tissues, organs, and systems.

[0006] There would be substantial advantages in providing a device or method capable of generating one or more stimuli that can alleviate one or more symptoms associated with a disorder, such as a craniofacial pain syndrome or headache syndrome, or treat one or more disorders. Summary of the Invention [Means for solving the problem]

[0007] A broad object of certain embodiments of the present invention may be to provide an ear canal pressure regulating device including: a fluid flow generator that generates a fluid flow; a valved conduit fluidly coupled to the fluid flow generator; a valved conduit having a first fluid flow conduit that is blockable by one or more valves to regulate fluid flow in one direction within the first fluid flow conduit; and an earphone having an axial earphone bore in communication between a first end of the earphone and a second end of the earphone, the axial earphone bore fluidly coupled to the valved conduit opposite the fluid flow generator, the earphone having a flexible outer earphone surface configured to sealably engage the ear canal as a barrier between ear canal pressure and ambient pressure.

[0008] Another broad object of certain embodiments of the present invention may be to provide an ear canal pressure regulation device that, in a first configuration, is coupled to a fluid flow generator and an earphone and has a valved conduit that unidirectionally regulates fluid flow in a first direction within a first fluid flow conduit such that fluid flow exits an axial earphone bore of the earphone toward the ear canal, thereby achieving an ear canal pressure above ambient pressure.

[0009] Another broad object of certain embodiments of the present invention may be to provide, in a second configuration, an ear canal pressure regulation device coupled to a fluid flow generator and an earphone, the ear canal pressure regulation device having a valved conduit that unidirectionally regulates fluid flow in a second direction within the first fluid flow conduit such that fluid flow can enter the ear canal from the ear canal into an axial earphone bore of the earphone, thereby achieving an ear canal pressure below ambient pressure.

[0010] Another broad object of certain embodiments of the present invention may be to provide an ear canal pressure regulation device having a valved conduit removably coupled to a fluid flow generator and an earphone. In a first configuration, the valved conduit is coupled to the fluid flow generator and the earphone and is capable of unidirectionally regulating fluid flow in a first direction within the first fluid flow conduit. Additionally, in a second configuration, the valved conduit is coupled to the fluid flow generator and the earphone and is capable of unidirectionally regulating fluid flow in a second direction within the first fluid flow conduit.

[0011] Another broad object of certain embodiments of the present invention may be to provide a method of producing an ear canal pressure regulating device, the method including: providing a fluid flow generator capable of generating a fluid flow; providing a valved conduit fluidly coupleable to the fluid flow generator, the valved conduit having a first fluid flow conduit; providing one or more valves within the first fluid flow conduit capable of blocking the first fluid flow conduit to regulate fluid flow in one direction; and providing an axial earphone bore in communication between a first end of the earphone and a second end of the earphone, the axial earphone bore fluidly coupleable to the valved conduit opposite the fluid flow generator, the earphone having a flexible outer earphone surface configured to sealably engage the ear canal as a barrier between ear canal pressure and ambient pressure.

[0012] Another broad object of certain embodiments of the present invention may be to provide a method of using an ear canal pressure regulating device, the method including the steps of obtaining an ear canal pressure regulating device comprising: 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 is blockable by one or more valves to regulate fluid flow in one direction within the first fluid flow conduit; and an earphone having an axial earphone bore in communication between a first end of the earphone and a second end of the earphone, the axial earphone bore being fluidly coupled to the valved conduit opposite the fluid flow generator, the earphone having a flexible outer earphone surface configured to sealably engage the ear canal as a barrier between ear canal pressure and ambient pressure; sealably engaging the outer earphone surface of the earphone with the ear canal; generating a fluid flow between the fluid flow generator and the axial earphone bore; and regulating a pressure difference in the ear canal between the ear canal pressure and ambient pressure.

[0013] Of course, further objects of the present invention are disclosed throughout other parts of the specification, the drawings, and the claims. The present specification also provides, for example, the following items: (Item 1) An ear canal pressure regulating device, comprising: a fluid flow generator for generating a fluid flow; a valved conduit fluidly coupled to the fluid flow generator, the valved conduit having a first fluid flow conduit blockable by a first valve to regulate fluid flow in one direction within the first fluid flow conduit; an earphone having an axial earphone bore in communication between a first end of the earphone and a second end of the earphone, the axial earphone bore fluidly coupled to the valved conduit facing the fluid flow generator, the earphone having a flexible earphone exterior surface configured to sealably engage the ear canal as a barrier between ear canal pressure and ambient pressure; A device comprising: (Item 2) Item 10. The device of item 1, wherein the fluid flow generator is configured to generate a fluid flow having a fluid volume in the range of 0 milliliters to about 20 milliliters. (Item 3) Item 3. The device of item 2, wherein the fluid volume has a preselected fluid volume. (Item 4) 4. The device of item 3, wherein the preselected fluid volume is selected from the group consisting of 0 milliliters to about 2 milliliters, about 1 milliliter to about 3 milliliters, about 2 milliliters to about 4 milliliters, about 3 milliliters to about 5 milliliters, about 4 milliliters to about 6 milliliters, about 5 milliliters to about 7 milliliters, about 6 milliliters to about 8 milliliters, about 7 milliliters to about 9 milliliters, about 8 milliliters to about 10 milliliters, about 9 milliliters to about 11 milliliters, about 10 milliliters to about 12 milliliters, about 11 milliliters to about 13 milliliters, about 12 milliliters to about 14 milliliters, about 13 milliliters to about 15 milliliters, about 14 milliliters to about 16 milliliters, about 15 milliliters to about 17 milliliters, about 16 milliliters to about 18 milliliters, about 17 milliliters to about 19 milliliters, and about 18 milliliters to about 20 milliliters. (Item 5) Item 10. The device of item 1, wherein the valved conduit has a configuration for removably coupling to the fluid flow generator and the earbud. (Item 6) Item 6. The device of item 5, wherein in a first configuration, the valved conduit couples with the fluid flow generator and the earphone and unidirectionally regulates the fluid flow in a first direction within the first fluid flow conduit. (Item 7) 7. The device of claim 6, wherein the valved conduit, in a second configuration, couples with the fluid flow generator and the earphone and unidirectionally regulates the fluid flow in a second direction within the first fluid flow conduit. (Item 8) Item 1. The device of item 1, wherein the first valve divides the first fluid flow conduit into a first portion proximate a first end of the first fluid flow conduit and a second portion proximate a second end of the first fluid flow conduit, and further comprises a second fluid flow conduit fluidly coupled between the first portion of the first fluid flow conduit and ambient pressure, the second fluid flow conduit being blockable by a second valve to regulate the fluid flow in one direction within the second fluid flow conduit. (Item 9) Item 9. The device of item 8, wherein the fluid flow generator comprises a volume-adjustable element having an internal volume, the volume-adjustable element having a deformed state that reduces the internal volume and generates a fluid flow in the first fluid flow conduit, and the first valve unidirectionally regulates the fluid flow so as to flow out of an axial earbud bore of the earbud. (Item 10) 10. The device of claim 9, wherein the volume-adjustable element returns to a non-deformed state increasing the internal volume and generating fluid flow in the second fluid flow conduit, the second valve adjusts the fluid flow unidirectionally from the ambient pressure toward the volume-adjustable element, and the first valve blocks fluid flow in the first fluid flow conduit from the second portion toward the first portion. (Item 11) Item 9. The device of item 8, wherein the fluid flow generator comprises a volume-adjustable element having an internal volume, the volume-adjustable element having a deformed state that reduces the internal volume and generates fluid flow in the second fluid flow conduit, and the second valve unidirectionally regulates the fluid flow out of the second fluid flow conduit toward the ambient pressure. (Item 12) Item 12. The device of item 11, wherein the volume adjustable element returns to an undeformed state increasing the internal volume and generating fluid flow in the first fluid flow conduit, the first valve unidirectionally regulates the fluid flow from an axial earphone bore of the earphone toward the volume adjustable element, and the second valve blocks fluid flow in the second fluid flow conduit from the ambient pressure toward the first portion. (Item 13) Item 9. The device of item 8, further comprising a third fluid flow conduit fluidly coupled between a second portion of the first fluid flow conduit and the ambient pressure, the third fluid flow conduit being shuttable by a third valve to regulate fluid flow in one direction within the third fluid flow conduit. (Item 14) Item 14. The device of item 13, wherein the third valve regulates the fluid flow to outlet to the ambient pressure. (Item 15) Item 14. The device of item 13, wherein the third valve regulates the fluid flow to flow in from the ambient pressure. (Item 16) Item 14. The device of item 13, wherein the third valve blocks fluid flow between the second portion of the first fluid flow conduit and the ambient pressure until the pressure difference between the second portion of the first fluid flow conduit and the ambient pressure exceeds a preselected pressure difference having a pressure difference amplitude of 0 kilopascals to about 50 kilopascals. (Item 17) The pressure difference amplitude is 0 kilopascal to about 5 kilopascals, about 2.5 kilopascals to about 7.5 kilopascals, about 5 kilopascals to about 10 kilopascals, about 7.5 kilopascals to about 12.5 kilopascals, about 10 kilopascals to about 15 kilopascals, about 12.5 kilopascals to about 17.5 kilopascals, about 15 kilopascals to about 20 kilopascals, about 17.5 kilopascals to about 22.5 kilopascals, about 20 kilopascals to about 25 kilopascals, about 22.5 kilopascals to about 27.5 kilopascals, about Item 17. The device of item 16, wherein the pressure is selected from the group consisting of 25 kilopascals to about 30 kilopascals, about 27.5 kilopascals to about 32.5 kilopascals, about 30 kilopascals to about 35 kilopascals, about 32.5 kilopascals to about 37.5 kilopascals, about 35 kilopascals to about 40 kilopascals, about 37.5 kilopascals to about 42.5 kilopascals, about 40 kilopascals to about 45 kilopascals, about 42.5 kilopascals to about 47.5 kilopascals, and about 45 kilopascals to about 50 kilopascals. (Item 18) Item 14. The device of item 13, further comprising a second valve pressure relief element coupled to the second valve and a third valve pressure relief element coupled to the third valve, each manually operable to generate fluid flow in the second or third fluid flow conduit, respectively. (Item 19) Item 14. The device of item 13, wherein the valved conduit coupled to the fluid flow generator and the earbud in a first configuration unidirectionally regulates the fluid flow in a first direction within the first fluid flow conduit so as to exit an axial earbud bore of the earbud. (Item 20) 20. The device of claim 19, wherein the fluid flow generator comprises a volume-adjustable element operable from an undeformed state toward a deformed state to generate a fluid flow out of the axial earbud bore over a period of time. (Item 21) Item 21. The device of item 20, wherein the fluid flow generator is repetitively operable from the undeformed state toward the deformed state to generate a fluid flow having pressure waves comprising a pressure wave amplitude and a pressure wave frequency. (Item 22) 22. The device of claim 21, wherein the pressure wave frequency is in the range of 0 hertz to about 10 hertz. (Item 23) The pressure wave frequency may be 0 Hz to about 1 Hz, about 0.5 Hz to about 1.5 Hz, about 1 Hz to about 2 Hz, about 1.5 Hz to about 2.5 Hz, about 2 Hz to about 3 Hz, about 2.5 Hz to about 3.5 Hz, about 3 Hz to about 4 Hz, about 3.5 Hz to about 4.5 Hz, about 4 Hz to about 5 Hz, about 4.5 Hz to about 5.5 Hz, or about 5 Hz to about 6 Hz. 23. The device of item 22, wherein the frequency is selected from one or more of the group consisting of about 5.5 Hz to about 6.5 Hz, about 6 Hz to about 7 Hz, about 6.5 Hz to about 7.5 Hz, about 7 Hz to about 8 Hz, about 7.5 Hz to about 8.5 Hz, about 8 Hz to about 9 Hz, about 8.5 Hz to about 9.5 Hz, and about 9 Hz to about 10 Hz. (Item 24) 22. The device of claim 21, wherein a third valve pressure relief element coupled to the fluid flow generator and the third valve is alternately and repeatedly operable to generate a fluid flow having a pressure wave comprising the pressure wave amplitude and the pressure wave frequency. (Item 25) Item 14. The device of item 13, wherein the valved conduit coupled to the fluid flow generator and the earbud in a second configuration unidirectionally regulates the fluid flow in a second direction within the first fluid flow conduit to enter the axial earbud bore. (Item 26) Item 26. The device of item 25, wherein the fluid flow generator comprises a volume-adjustable element operable from a deformed state toward an undeformed state to generate a fluid flow into the axial earphone bore over a period of time. (Item 27) Item 27. The device of item 26, wherein the fluid flow generator is repetitively operable from the deformed state toward the undeformed state to generate a fluid flow having pressure waves comprising a pressure wave amplitude and a pressure wave frequency. (Item 28) Item 28. The device of item 27, wherein the pressure wave frequency is in the range of 0 hertz to about 10 hertz. (Item 29) The pressure wave frequency may be 0 Hz to about 1 Hz, about 0.5 Hz to about 1.5 Hz, about 1 Hz to about 2 Hz, about 1.5 Hz to about 2.5 Hz, about 2 Hz to about 3 Hz, about 2.5 Hz to about 3.5 Hz, about 3 Hz to about 4 Hz, about 3.5 Hz to about 4.5 Hz, about 4 Hz to about 5 Hz, about 4.5 Hz to about 5.5 Hz, or about 5 Hz to about 6 Hz. 29. The device of item 28, wherein the frequency is selected from one or more of the group consisting of about 5.5 Hz to about 6.5 Hz, about 6 Hz to about 7 Hz, about 6.5 Hz to about 7.5 Hz, about 7 Hz to about 8 Hz, about 7.5 Hz to about 8.5 Hz, about 8 Hz to about 9 Hz, about 8.5 Hz to about 9.5 Hz, and about 9 Hz to about 10 Hz. (Item 30) Item 28. The device of item 27, wherein a third valve pressure relief element coupled to the fluid flow generator and the third valve is alternately and repeatedly operable to generate a fluid flow having a pressure wave comprising the pressure wave amplitude and the pressure wave frequency. (Item 31) 1. A method for producing an ear canal pressure regulating device, comprising: providing a fluid flow generator capable of generating a fluid flow; providing a valved conduit fluidly connectable to the fluid flow generator, the valved conduit having a first fluid flow conduit; providing a first valve blocking the first fluid flow conduit and capable of unidirectionally adjusting fluid flow in the first fluid flow conduit; providing an axial earbud bore in communication between a first end of the earbud and a second end of the earbud, the axial earbud bore being fluidly connectable to the valved conduit facing the fluid flow generator, the earbud having a flexible earbud exterior surface configured to sealably engage the ear canal as a barrier between ear canal pressure and ambient pressure; A method comprising: (Item 32) Item 32. The method of item 31, further comprising providing the fluid stream generator with a configuration capable of generating a fluid stream having a fluid volume in the range of 0 milliliters to about 20 milliliters. (Item 33) Item 33. The method of item 32, wherein the fluid volume comprises a preselected fluid volume. (Item 34) Item 34. The method of item 33, wherein the preselected fluid volume is selected from the group consisting of 0 milliliters to about 2 milliliters, about 1 milliliter to about 3 milliliters, about 2 milliliters to about 4 milliliters, about 3 milliliters to about 5 milliliters, about 4 milliliters to about 6 milliliters, about 5 milliliters to about 7 milliliters, about 6 milliliters to about 8 milliliters, about 7 milliliters to about 9 milliliters, about 8 milliliters to about 10 milliliters, about 9 milliliters to about 11 milliliters, about 10 milliliters to about 12 milliliters, about 11 milliliters to about 13 milliliters, about 12 milliliters to about 14 milliliters, about 13 milliliters to about 15 milliliters, about 14 milliliters to about 16 milliliters, about 15 milliliters to about 17 milliliters, about 16 milliliters to about 18 milliliters, about 17 milliliters to about 19 milliliters, and about 18 milliliters to about 20 milliliters. (Item 35) 32. The method of claim 31, further comprising providing the valved conduit with a configuration that is removably coupleable to the fluid flow generator and the earbud. (Item 36) Item 36. The method of item 35, further comprising providing the valved conduit coupled to the fluid flow generator and the earphone in a first configuration and having a configuration that allows the fluid flow to be unidirectionally adjustable in a first direction within the first fluid flow conduit. (Item 37) Item 37. The method of item 36, further comprising providing the valved conduit coupled to the fluid flow generator and the earphone in a second configuration, the valved conduit having a configuration that allows unidirectional adjustment of the fluid flow in a second direction within the first fluid flow conduit. (Item 38) Item 32. The method of item 31, further comprising the steps of: providing a first valve having a configuration capable of dividing the first fluid flow conduit into a first portion proximate a first end of the first fluid flow conduit and a second portion proximate a second end of the first fluid flow conduit; providing a second fluid flow conduit having a configuration capable of fluidly coupling between the first portion of the first fluid flow conduit and the ambient pressure; and providing a second valve having a configuration capable of blocking the second fluid flow conduit and unidirectionally adjusting the fluid flow within the second fluid flow conduit. (Item 39) Item 39. The method of item 38, further comprising providing the fluid flow generator configured as a volume-adjustable element having an internal volume, the volume-adjustable element having a deformed state that reduces the internal volume and generates a fluid flow in the first fluid flow conduit, and the first valve unidirectionally regulates the fluid flow to flow out of an axial earphone bore of the earphone. (Item 40) Item 39. The method of item 39, wherein the volume-adjustable element returns to a non-deformed state increasing the internal volume and generating fluid flow in the second fluid flow conduit, the second valve unidirectionally regulates the fluid flow from the ambient pressure toward the volume-adjustable element, and the first valve blocks fluid flow in the first fluid flow conduit from the second portion toward the first portion. (Item 41) Item 39. The method of item 38, further comprising providing the fluid flow generator configured as a volume-adjustable element having an internal volume, the volume-adjustable element having a deformed state that reduces the internal volume and generates a fluid flow in the second fluid-flow conduit, and the second valve unidirectionally adjusts the fluid flow so that it flows out of the second fluid-flow conduit toward the ambient pressure. (Item 42) Item 42. The method of item 41, wherein the volume adjustable element returns to an undeformed state increasing the internal volume and generating fluid flow in the first fluid flow conduit, the first valve unidirectionally regulates the fluid flow from an axial earphone bore of the earphone toward the volume adjustable element, and the second valve blocks fluid flow in the second fluid flow conduit from the ambient pressure toward the first portion. (Item 43) Item 39. The method of item 38, further comprising the step of providing a third fluid flow conduit having a configuration capable of fluidly coupling between a second portion of the first fluid flow conduit and the ambient pressure, and further comprising the step of providing a third valve having a configuration capable of blocking the third fluid flow conduit and adjusting fluid flow in the third fluid flow conduit in one direction. (Item 44) Item 44. The method of item 43, further comprising providing the third valve with a configuration that allows the fluid flow to be adjusted to outlet to the ambient pressure. (Item 45) Item 44. The method of item 43, further comprising providing the third valve with a configuration that allows the fluid flow to be adjusted to flow in from the ambient pressure. (Item 46) Item 44. The method of item 43, further comprising providing the third valve having a configuration operable to block fluid flow between the second portion of the first fluid flow conduit and the ambient pressure until a pressure differential between the second portion of the first fluid conduit and the ambient pressure exceeds a preselected pressure differential having a pressure differential amplitude of between 0 kilopascals and about 50 kilopascals. (Item 47) The pressure difference amplitude is 0 kilopascal to about 5 kilopascals, about 2.5 kilopascals to about 7.5 kilopascals, about 5 kilopascals to about 10 kilopascals, about 7.5 kilopascals to about 12.5 kilopascals, about 10 kilopascals to about 15 kilopascals, about 12.5 kilopascals to about 17.5 kilopascals, about 15 kilopascals to about 20 kilopascals, about 17.5 kilopascals to about 22.5 kilopascals, about 20 kilopascals to about 25 kilopascals, about 22.5 kilopascals to about 27.5 kilopascals, Item 47. The method of item 46, wherein the pressure is selected from the group consisting of about 25 kilopascals to about 30 kilopascals, about 27.5 kilopascals to about 32.5 kilopascals, about 30 kilopascals to about 35 kilopascals, about 32.5 kilopascals to about 37.5 kilopascals, about 35 kilopascals to about 40 kilopascals, about 37.5 kilopascals to about 42.5 kilopascals, about 40 kilopascals to about 45 kilopascals, about 42.5 kilopascals to about 47.5 kilopascals, and about 45 kilopascals to about 50 kilopascals. (Item 48) Item 44. The method of item 43, further comprising providing a second valve pressure relief element having a configuration coupleable to the second valve and a third valve pressure relief element having a configuration coupleable to the third valve, each manually operable to generate fluid flow in the second or third fluid flow conduit, respectively. (Item 49) Item 44. The method of item 43, further comprising providing the valved conduit, in a first configuration, coupled to the fluid flow generator and the earbud and having a configuration that allows the fluid flow to be unidirectionally adjustable in a first direction within the first fluid flow conduit to exit an axial earbud bore of the earbud. (Item 50) 50. The method of claim 49, further comprising providing the fluid flow generator as a volume-adjustable element operable from an undeformed state toward a deformed state to generate a fluid flow out of the axial earphone bore over a period of time. (Item 51) Item 51. The device of item 50, further comprising providing the fluid flow generator having a configuration that is repeatedly operable from the undeformed state toward the deformed state to generate a fluid flow having pressure waves that include a pressure wave amplitude and a pressure wave frequency. (Item 52) Item 52. The method according to item 51, wherein the pressure wave frequency is in the range of 0 hertz to about 10 hertz. (Item 53) The pressure wave frequency may be 0 Hz to about 1 Hz, about 0.5 Hz to about 1.5 Hz, about 1 Hz to about 2 Hz, about 1.5 Hz to about 2.5 Hz, about 2 Hz to about 3 Hz, about 2.5 Hz to about 3.5 Hz, about 3 Hz to about 4 Hz, about 3.5 Hz to about 4.5 Hz, about 4 Hz to about 5 Hz, about 4.5 Hz to about 5.5 Hz, or about 5 Hz to about 6 Hz. 53. The method of claim 52, wherein the frequency is selected from one or more of the group consisting of about 5.5 Hz to about 6.5 Hz, about 6 Hz to about 7 Hz, about 6.5 Hz to about 7.5 Hz, about 7 Hz to about 8 Hz, about 7.5 Hz to about 8.5 Hz, about 8 Hz to about 9 Hz, about 8.5 Hz to about 9.5 Hz, and about 9 Hz to about 10 Hz. (Item 54) Item 52. The method of item 51, further comprising providing a third valve pressure relief element having a configuration capable of being coupled to the third valve, wherein the fluid flow generator and the third valve pressure relief element are alternately and repeatedly operable to generate a fluid flow having a pressure wave comprising the pressure wave amplitude and the pressure wave frequency. (Item 55) Item 44. The method of item 43, further comprising providing the valved conduit, in a second configuration, coupled to the fluid flow generator and the earbud and having a configuration that allows unidirectional adjustment of the fluid flow in a second direction within the first fluid flow conduit to enter an axial earbud bore of the earbud. (Item 56) Item 56. The method of item 55, further comprising providing the fluid flow generator configured as a volume-adjustable element operable from a deformed state toward an undeformed state to generate a fluid flow into the axial earphone bore over a period of time. (Item 57) Item 57. The method of item 56, further comprising providing the fluid flow generator with a configuration that is repeatedly operable from the deformed state toward the undeformed state to generate a fluid flow having pressure waves that include a pressure wave amplitude and a pressure wave frequency. (Item 58) Item 58. The method according to item 57, wherein the pressure wave frequency is in the range of 0 hertz to about 10 hertz. (Item 59) The pressure wave frequency may be 0 Hz to about 1 Hz, about 0.5 Hz to about 1.5 Hz, about 1 Hz to about 2 Hz, about 1.5 Hz to about 2.5 Hz, about 2 Hz to about 3 Hz, about 2.5 Hz to about 3.5 Hz, about 3 Hz to about 4 Hz, about 3.5 Hz to about 4.5 Hz, about 4 Hz to about 5 Hz, about 4.5 Hz to about 5.5 Hz, or about 5 Hz to about 6 Hz. 59. The method of claim 58, wherein the frequency is selected from one or more of the group consisting of about 5.5 Hz to about 6.5 Hz, about 6 Hz to about 7 Hz, about 6.5 Hz to about 7.5 Hz, about 7 Hz to about 8 Hz, about 7.5 Hz to about 8.5 Hz, about 8 Hz to about 9 Hz, about 8.5 Hz to about 9.5 Hz, and about 9 Hz to about 10 Hz. (Item 60) Item 58. The method of item 57, further comprising providing a third valve pressure relief element having a configuration capable of being coupled to the third valve, wherein the fluid flow generator and the third valve pressure relief element are alternately and repeatedly operable to generate a fluid flow having a pressure wave comprising the pressure wave amplitude and the pressure wave frequency. (Item 61) 1. A method of using an ear canal pressure regulating device, comprising: Obtaining the ear canal pressure regulating device, the ear canal pressure regulating device comprising: a fluid flow generator for generating a fluid flow; a valved conduit fluidly coupled to the fluid flow generator, the valved conduit having a first fluid flow conduit blockable by a first valve to regulate fluid flow in one direction within the first fluid flow conduit; an earphone having an axial earphone bore in communication between a first end of the earphone and a second end of the earphone, the axial earphone bore fluidly coupled to the valved conduit facing the fluid flow generator, the earphone having a flexible earphone exterior surface configured to sealably engage the ear canal as a barrier between ear canal pressure and ambient pressure; and sealingly engaging an earphone exterior surface of the earphone with the ear canal; generating a fluid flow between the fluid flow generator and the axial earphone bore; adjusting the ear canal pressure difference between the ear canal pressure and the ambient pressure; A method comprising: (Item 62) 1. A method of using an ear canal pressure regulating device, comprising: Obtaining the ear canal pressure regulating device, the ear canal pressure regulating device comprising: a fluid flow generator for generating a fluid flow; a valved conduit having a first fluid-flow conduit that can be shut off by a first valve to regulate fluid flow in one direction within the first fluid-flow conduit; an earphone having an axial earphone bore in communication between a first end of the earphone and a second end of the earphone, the earphone having a flexible earphone exterior surface configured to sealably engage the ear canal as a barrier between ear canal pressure and ambient pressure; and fluidly coupling the valved conduit in a first configuration with the fluid flow generator and an axial earphone bore of the earphone, and unidirectionally regulating the fluid flow in a first direction within the first fluid flow conduit; sealingly engaging an earphone exterior surface of the earphone with the ear canal; generating a fluid flow in the first fluid flow conduit in the first direction between the fluid flow generator and the axial earphone bore; adjusting a pressure difference between the ear canal pressure and the ambient pressure, wherein the ear canal pressure is greater than the ambient pressure; A method comprising: (Item 63) Item 63. The method of item 62, further comprising operating a pressure relief element to generate a fluid flow from the ear canal toward the ambient pressure and return the ear canal pressure to the ambient pressure. (Item 64) Item 64. The method of item 63, further comprising the step of disengaging an earphone exterior surface of the earphone from the ear canal. (Item 65) Item 65. The method of item 64, further comprising decoupling the valved conduit in the first configuration from the fluid flow generator and an axial earphone bore of the earphone. (Item 66) fluidly coupling the valved conduit in a second configuration with the fluid flow generator and an axial earphone bore of the earphone to unidirectionally regulate the fluid flow in a second direction within the first fluid flow conduit; sealingly engaging an earphone exterior surface of the earphone with the ear canal; generating a fluid flow in the first fluid flow conduit in the second direction between the fluid flow generator and the axial earphone bore; adjusting a pressure difference between the ear canal pressure and the ambient pressure, wherein the ear canal pressure is less than the ambient pressure; Item 66. The method of item 65, further comprising: (Item 67) Item 67. The method of item 66, further comprising operating a pressure relief element to generate a fluid flow from the ambient pressure toward the ear canal and return the ear canal pressure to the ambient pressure. (Item 68) Item 68. The method of item 67, further comprising the step of disengaging an earphone exterior surface of the earphone from the ear canal. (Item 69) Item 69. The method of item 68, further comprising decoupling the valved conduit in the second configuration from the fluid flow generator and an axial earphone bore of the earphone. [Brief explanation of the drawings]

[0014] [Figure 1A] FIG. 1A is an illustration of a particular embodiment of an ear canal pressure regulating device sealably engaged with the ear canal. [Figure 1B] FIG. 1B is an illustration of a particular embodiment of an ear canal pressure regulating device that is sealably engaged with the ear canal. [Figure 2A] FIG. 2A is a schematic diagram of a particular embodiment of an ear canal pressure regulating device operable to achieve an ear canal pressure above ambient pressure. [Figure 2B] FIG. 2B is a schematic diagram of a particular embodiment of an ear canal pressure regulating device operable to achieve ear canal pressure below ambient pressure. [Figure 3A] FIG. 3A is a cross-sectional view of a particular embodiment of a valve that may be utilized in embodiments of an ear canal pressure regulating device. [Figure 3B] FIG. 3B is a cross-sectional view of a particular embodiment of a valve that may be utilized in embodiments of an ear canal pressure regulating device. [Figure 3C] FIG. 3C is a cross-sectional view of a particular embodiment of a valve that may be utilized in embodiments of an ear canal pressure regulating device. [Figure 3D] FIG. 3D is a cross-sectional view of a particular embodiment of a valve that may be utilized in embodiments of an ear canal pressure regulating device. [Figure 3E] FIG. 3E is a cross-sectional view of a particular embodiment of a valve that may be utilized in embodiments of an ear canal pressure regulating device. [Figure 4A] FIG. 4A is an illustration of a particular embodiment of an ear canal pressure regulating device. [Figure 4B]FIG. 4B is an illustration of a particular embodiment of an ear canal pressure regulating device. [Figure 4C] FIG. 4C is an illustration of a particular embodiment of an ear canal pressure regulating device. [Figure 4D] FIG. 4D is an illustration of a particular embodiment of an ear canal pressure regulating device. [Figure 4E] FIG. 4E is an illustration of a particular embodiment of an ear canal pressure regulating device. [Figure 4F] FIG. 4F is an illustration of a particular embodiment of an ear canal pressure regulating device. [Figure 4G] FIG. 4G is an illustration of the specific embodiment of the ear canal pressure regulating device shown in FIG. 4F, in which the earbud is decoupled from the fluid flow generator and conduit body. [Figure 4H] FIG. 4H is an illustration of a particular embodiment of an ear canal pressure regulating device. [Figure 4I] FIG. 4I is an illustration of a particular embodiment of an ear canal pressure regulating device. [Figure 5] FIG. 5 is a cross-sectional view of a particular embodiment of an ear canal pressure regulation device operable to achieve an ear canal pressure above ambient pressure. [Figure 6] FIG. 6 is a cross-sectional view of a particular embodiment of an ear canal pressure regulation device operable to achieve ear canal pressure below ambient pressure. [Figure 7] FIG. 7 is an exploded view of a particular embodiment of the ear canal pressure regulating device shown in FIG. 5 that is operable to achieve ear canal pressures above ambient pressure. [Figure 8] FIG. 8 is an illustration of a first configuration of an ear canal pressure regulating device operable to achieve an ear canal pressure above ambient pressure. [Figure 9] FIG. 9 is an illustration of a method for reconfiguring the first configuration of the ear canal pressure regulating device shown in FIG. 8 by end-to-end rotation of the conduit body. [Figure 10] FIG. 10 is an illustration of a second configuration of the ear canal pressure regulating device, achieved by end-to-end rotation of the conduit body operable to achieve an ear canal pressure below ambient pressure. [Figure 11A]FIG. 11A is an illustration of a first configuration of an ear canal pressure regulating device having an earbud exterior surface that is sealably engaged with the ear canal. [Figure 11B] FIG. 11B is an illustration of a first configuration of an ear canal pressure regulating device having an earbud exterior surface that sealably engages the ear canal and having a fluid flow generator in a deformed state that generates sufficient pressure within the valved conduit to place the first valve in an open state and provide a fluid flow toward the ear canal to achieve an ear canal pressure above ambient pressure. [Figure 11C] FIG. 11C is an illustration of a first configuration of an ear canal pressure regulating device having an earbud exterior surface that sealably engages the ear canal and a fluid flow generator that generates sufficient pressure to place a first valve in a closed state, maintain ear canal pressure, and place a second valve in an open state, generating a fluid flow from ambient pressure toward the fluid flow generator and returning to an undeformed state. [Figure 11D] FIG. 11D is an illustration of a first configuration of an ear canal pressure regulating device having an earbud exterior surface that sealably engages the ear canal and a third valve that is manually placed in an open state by operation of a pressure relief element to generate fluid flow from the ear canal toward ambient pressure and return ear canal pressure to ambient pressure. [Figure 12A] FIG. 12A is an illustration of a second configuration of an ear canal pressure regulating device having an earbud exterior surface that is sealingly engaged with the ear canal. [Figure 12B] FIG. 12B is an illustration of a second configuration of an ear canal pressure regulating device having an earbud exterior surface that sealably engages the ear canal and having the fluid flow generator in a deformed state that generates sufficient pressure within the valved conduit to place the second valve in an open state and provide fluid flow toward ambient pressure while maintaining the ear canal pressure at ambient pressure. [Figure 12C] FIG. 12C is an illustration of a second configuration of an ear canal pressure regulating device having an earbud exterior surface that sealably engages the ear canal and a fluid flow generator that generates sufficient pressure to place the first valve in an open state and the second valve in a closed state, generating fluid flow from the ear canal toward the fluid flow generator and returning to an undeformed state to generate an ear canal pressure that is below ambient pressure. [Figure 12D] FIG. 12D is an illustration of a second configuration of an ear canal pressure regulating device having an earbud exterior surface that sealably engages the ear canal and a third valve that is manually placed in an open state by operation of a pressure relief element to generate fluid flow from ambient pressure toward the ear canal and return ear canal pressure to ambient pressure. [Figure 13A] FIG. 13A is a top view of a particular embodiment of an ear canal pressure regulating device. [Figure 13B] FIG. 13B is a side view of a particular embodiment of an ear canal pressure regulating device. [Figure 13C] FIG. 13C is an exploded view of a particular embodiment of an ear canal pressure regulating device. [Figure 13D] FIG. 13D is an exploded view of a particular embodiment of an ear canal pressure regulating device. [Figure 13E] FIG. 13E is a cross-sectional view of a particular embodiment of the ear canal pressure regulating device shown in FIG. 13A operable to generate ear canal pressure above ambient pressure. [Figure 13F] FIG. 13F is a cross-sectional view of a particular embodiment of an ear canal pressure regulation device operable to generate ear canal pressure below ambient pressure. [Figure 14A] FIG. 14A is a plot of ear canal pressure achieved against ambient pressure over a period of time, illustrating use of a first configuration of an ear canal pressure regulating device in which operation of the fluid flow generator generates a substantially constant ear canal pressure above ambient pressure, maintains it at the maximum pressure for a period of time, and operation of the pressure relief element returns the ear canal pressure to ambient pressure. [Figure 14B] FIG. 14B is a plot of ear canal pressure achieved against ambient pressure over a period of time, illustrating the use of a first configuration of an ear canal pressure regulating device in which operation of the fluid flow generator, along with intermittent operation of the pressure relief element, generates a pulsed ear canal pressure above ambient pressure, and the pressure wave is a sine wave with smooth, repeating periodic oscillations. [Figure 14C]FIG. 14C is a plot of ear canal pressure achieved against ambient pressure over a period of time, representing a method of use of a first configuration of an ear canal pressure regulating device, in which operation of the fluid flow generator in conjunction with intermittent operation of the pressure relief element generates a pulsed ear canal pressure above ambient pressure, the pressure wave being a trapezoidal wave whose peak has a constant pressure over a period of time. [Figure 14D] FIG. 14D is a plot of ear canal pressure achieved against ambient pressure over a period of time, illustrating the use of a first configuration of an ear canal pressure regulating device, in which operation of the fluid flow generator, along with intermittent operation of the pressure relief element, generates a pulsed ear canal pressure above ambient pressure, and the pressure wave is a triangular wave with linear leading and trailing edges. [Figure 14E] FIG. 14E is a plot of ear canal pressure achieved against ambient pressure over a period of time, representing the use of a first configuration of an ear canal pressure regulating device, in which operation of the fluid flow generator, along with intermittent operation of the pressure relief element, generates a pulsed ear canal pressure above ambient pressure, and the pressure wave is a sawtooth wave whose leading edge changes pressure over a period of time that exceeds the period of time in which the trailing edge changes pressure. [Figure 14F] Figure 14F is a plot of ear canal pressure achieved against ambient pressure over a period of time, representing the use of a first configuration of an ear canal pressure regulating device, in which operation of the fluid flow generator, along with intermittent operation of the pressure relief element, generates a pulsed ear canal pressure above ambient pressure, and the pressure wave is a trapezoidal wave whose peak has a constant pressure over a period of time. [Figure 14G] FIG. 14G is a plot of ear canal pressure achieved against ambient pressure over a period of time, illustrating the use of a first configuration of an ear canal pressure regulating device in which operation of the fluid flow generator, along with intermittent operation of the pressure relief element, generates a pulsed ear canal pressure above ambient pressure. [Figure 15A]FIG. 15A is a plot of ear canal pressure achieved against ambient pressure over a period of time, illustrating use of a second configuration of the ear canal pressure regulating device, in which operation of the fluid flow generator generates a substantially constant ear canal pressure below ambient pressure, maintains it at maximum pressure for a period of time, and operation of the pressure relief element returns the ear canal pressure to ambient pressure. [Figure 15B] Figure 15B is a plot of ear canal pressure achieved against ambient pressure over a period of time, illustrating the use of a second configuration of the ear canal pressure regulating device, in which operation of the fluid flow generator, along with intermittent operation of the pressure relief element, generates a pulsed ear canal pressure below ambient pressure, and the pressure wave is a sine wave with smooth, repeating periodic oscillations. [Figure 15C] Figure 15C is a plot of ear canal pressure achieved against ambient pressure over a period of time, representing the use of a second configuration of the ear canal pressure regulating device, in which operation of the fluid flow generator, along with intermittent operation of the pressure relief element, generates a pulsed ear canal pressure below ambient pressure, and the pressure wave is a trapezoidal wave whose peak has a constant pressure over a period of time. [Figure 15D] Figure 15D is a plot of ear canal pressure achieved against ambient pressure over a period of time, illustrating the use of a second configuration of the ear canal pressure regulating device, in which operation of the fluid flow generator along with intermittent operation of the pressure relief element generates a pulsed ear canal pressure below ambient pressure, and the pressure wave is a triangular wave with linear leading and trailing edges. [Figure 15E] Figure 15E is a plot of ear canal pressure achieved against ambient pressure over a period of time, representing the use of a second configuration of the ear canal pressure regulating device, in which operation of the fluid flow generator in conjunction with intermittent operation of the pressure relief element generates a pulsed ear canal pressure below ambient pressure, and the pressure wave is an inverted sawtooth wave in which the leading edge changes pressure over a period of time that is less than the period in which the trailing edge changes pressure. [Figure 15F]Figure 15F is a plot of ear canal pressure achieved against ambient pressure over a period of time, representing the use of a second configuration of the ear canal pressure regulating device, in which operation of the fluid flow generator, along with intermittent operation of the pressure relief element, generates a pulsed ear canal pressure below ambient pressure, and the pressure wave is a trapezoidal wave whose peak has a constant pressure over a period of time. [Figure 15G] FIG. 15G is a plot of ear canal pressure achieved against ambient pressure over a period of time, illustrating the use of a second configuration of the ear canal pressure regulating device, in which operation of the fluid flow generator, along with intermittent operation of the pressure relief element, generates pulsed ear canal pressure below ambient pressure. DETAILED DESCRIPTION OF THE INVENTION

[0015] Reference is now made primarily to Figures 1A and 1B, which illustrate a particular method of use of an ear canal pressure regulating device (1) including one or more of a fluid flow generator (2), an earphone (3) having an axial earphone bore (4), and a valved conduit (5) fluidly coupled to the fluid flow generator (2) and the axial earphone bore (4). The method of use may include sealingly engaging an ear canal (6) with an outer earphone surface (7) of the earphone (3), generating a fluid flow (8) between the fluid flow generator (2) and the axial earphone bore (4), and regulating a pressure differential (9) between ear canal pressure (10) and ambient pressure (11) to alleviate one or more disorder symptoms or treat one or more disorders.

[0016] For purposes of the present invention, the term "pressure differential" means the difference in pressure between two locations.

[0017] For purposes of the present invention, the term "pressure differential amplitude" means the numerical value of the difference in pressure between two locations. The pressure differential amplitude (59) can be expressed as a number without sign (positive or negative), regardless of whether the pressure is greater or less at a first location relative to a second location. As an illustrative example, an ear canal pressure (10) of +50 kilopascals above ambient pressure (11) and an ear canal pressure (10) of -50 kilopascals below ambient pressure (11) can both have a pressure differential amplitude (59) of 50 kilopascals.

[0018] The term "ear canal pressure" for purposes of the present invention means a force imparted within the ear canal (6), and is not limited to the aforementioned categories, but refers to a force imparted within the ear canal (6) by a fluid flow (8) delivered to or generated within the ear canal (6) by operation of a fluid volume (12), a preselected fluid volume (12), or an ear canal pressure regulating device (1).

[0019] For purposes of the present invention, the term "ambient pressure" means a force externally applied to the ear canal (6) within the ambient environment, and is not limited to the aforementioned categories, but refers to a force applied on an earphone (3) having an earphone exterior surface (7) that is sealingly engaged with the ear canal (6), as described herein.

[0020] For purposes of the present invention, the term "preselected" refers to a parameter, such as a fluid volume (12) or pressure differential amplitude (59), determined prior to administration, for delivery to, generation within, or administration to the ear canal (6) by operation of the ear canal pressure adjustment device (1), e.g., by a user (23) of the ear canal pressure adjustment device (1), and subsequently delivered to, generated within, or administered to the ear canal (6) by operation of the ear canal pressure adjustment device (1). For example, a preselected fluid volume (12) of 10 milliliters can be preselected for delivery to the ear canal (6) by operation of the ear canal pressure adjustment device (1), and subsequently, the preselected fluid volume (12) of 10 milliliters can be delivered to the ear canal (6) by operation of the ear canal pressure adjustment device (1).

[0021] For purposes of the present invention, the term "symptom" means any discomfort or combination of discomforts associated with a disorder. Without being limited to the foregoing categories, symptoms may include dizziness, spatial disorientation, nausea, claudication, tactile illusions, paresthesia, light sensitivity, olfactory sensitivity, sound sensitivity, anxiety, insomnia, irritability, fatigue, loss of appetite, blurred vision, gait disturbances, acute or chronic pain of various characteristics, including, but not limited to, throbbing, tearing, sharp, dull, deep, spearing, burning, aching, stabbing, burning, electric shock, swelling, or tingling; or the like; or combinations thereof.

[0022] For purposes of the present invention, the term "disorder" refers to a physical or mental condition that is not normal or healthy. Without being limited to the aforementioned categories, disorders may include neuropathological craniofacial pain syndromes such as neuralgia, e.g., trigeminal neuralgia; temporomandibular joint syndrome; headache syndromes such as migraine, chronic daily headache, cluster headache, muscle tension headache, post-traumatic headache, or chronic paroxysmal hemicrania; endolymphatic hydrops; spatial disorientation; tinnitus; syndromes resulting from brain injury; syndromes resulting from neurological dysfunction, including cognitive disorders such as attention deficit disorder, emotional disorders such as anxiety disorders, or seizure disorders; phantom limb; middle ear disorder; inner ear disorder; or the like, or combinations thereof.

[0023] 2A and 2B, the fluid flow generator (2) can have any of a number of different configurations capable of generating a fluid flow (8) between the fluid flow generator (2) and the axial earphone bore (4). For certain embodiments, the fluid flow generator (2) can include a volume-adjustable element (13) that is adjustable between a larger volume and a smaller volume. As an illustrative example, adjusting the volume-adjustable element (13) from a larger volume to a smaller volume can generate a fluid flow (8) from the fluid flow generator (2), while adjusting the volume-adjustable element (13) from a smaller volume to a larger volume can generate a fluid flow (8) toward the fluid flow generator (2).

[0024] For certain embodiments, the fluid flow generator (2) can include a bladder (14) or diaphragm (15) having an elastically flexible wall (16) with a wall exterior surface (17) and a wall interior surface (18). The wall exterior surface (17) can be configured in any manner that allows deformation of the elastically flexible wall (16) (as shown in the examples of FIGS. 11A-12D and 13A-13F). The wall interior surface (18) can define an interior volume (19) (whether in whole or in part as an assembly with a valved conduit (5)). The elastically flexible wall (16) can decrease its interior volume (19) in a deformed state (20) (as shown in the examples of FIGS. 11B and 12B) and alternatively increase its interior volume (19) toward an undeformed state (21) (as shown in the examples of FIGS. 11C and 12C). The change in internal volume (19) can generate fluid flow (8) between the fluid flow generator (2) and the axial earphone bore (4), which can be regulated by the valved conduit (5). For certain embodiments, the bladder (14) or diaphragm (15) can have an internal volume (19) in the undeformed state (21) that, upon complete reduction of the internal volume (19) to the deformed state (20), may be insufficient to generate an amount of fluid flow (8) or pressure (22) sufficient to cause discomfort to a user (23) of the ear canal pressure regulating device (1) or injury to the ear canal (24) or tympanic membrane (25).

[0025] For certain other embodiments, the fluid flow generator (2) can include a positive displacement pump (26) with a piston (27) reciprocating within a barrel (28) (as shown in the illustrative example in FIG. 4C ) to adjust the barrel's internal volume between a smaller volume and a larger volume. The reciprocating motion of the piston (27) within the barrel (28) can generate a fluid flow (8) between the fluid flow generator (2) and the axial earphone bore (4), which can be regulated by a valved conduit (5). For certain embodiments, the barrel (28) can have an internal barrel volume that, upon complete reduction of the barrel's internal volume due to the advancement of the piston (27) within the barrel (28), may be insufficient to generate an amount of fluid flow (8) or pressure (22) sufficient to cause discomfort to a user (23) of the ear canal pressure adjustment device (1) or damage to the ear canal (24) or tympanic membrane (25).

[0026] 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 earphone bore (4), whereby the fluid flow (8) can have a fluid volume (12) typically in the range of 0 milliliters to about 20 milliliters. However, embodiments can have a lesser or greater fluid volume (12) depending on the application. For certain embodiments, the fluid volume (12) can be between 0 milliliters and about 2 milliliters, about 1 milliliter and about 3 milliliters, about 2 milliliters and about 4 milliliters, about 3 milliliters and about 5 milliliters, about 4 milliliters and about 6 milliliters, about 5 milliliters and about 7 milliliters, about 6 milliliters and about 8 milliliters, about 7 milliliters and about 9 milliliters, about 8 milliliters and about 10 milliliters, about 9 milliliters and about 11 milliliters, about 10 milliliters and about 12 milliliters, about 11 milliliters and about 13 milliliters, about 14 milliliters and about 15 milliliters, about 16 milliliters and about 17 milliliters, about 18 milliliters and about 20 milliliters, about 19 milliliters and about 21 milliliters, about 22 milliliters and about 23 milliliters, about 24 milliliters and about 25 milliliters, about 26 milliliters and about 27 milliliters, about 28 milliliters and about 29 milliliters, about 29 milliliters and about 30 milliliters, about 30 milliliters and about 31 milliliters, about 32 milliliters and about 33 milliliters, about 34 milliliters and about 35 milliliters, about 36 milliliters and about 37 milliliters, about 38 milliliters and about 39 milli The preselected fluid volume (12) may be selected from one or more of the group including or consisting of milliliters to about 13 milliliters, about 12 milliliters to about 14 milliliters, about 13 milliliters to about 15 milliliters, about 14 milliliters to about 16 milliliters, about 15 milliliters to about 17 milliliters, about 16 milliliters to about 18 milliliters, about 17 milliliters to about 19 milliliters, and about 18 milliliters to about 20 milliliters.

[0027] Depending on the method of use, one or more preselected fluid volumes (12) can be generated using the ear canal pressure adjustment device (1), which may be further influenced by factors such as the anatomy, physiology, or biochemistry of the user (23) of the ear canal (24); the target disorder symptoms to be alleviated; the target disorder to be treated; the observable effects of using one or more preselected fluid volumes (12) in the particular method of use of the ear canal pressure adjustment device (1); or the like; or a combination thereof, but not to the extent that it causes discomfort to the user (23) or damage to the ear canal (24) or eardrum (25).

[0028] 2A and 2B, earphone 3 can have a flexible earphone exterior surface 7 configured to be inserted into ear canal 6 of ear canal 24 and thus act as a barrier between ear canal pressure 10 and ambient pressure 11. Embodiments of earphone 3 can be configured to sufficiently sealingly engage ear canal 6, resist axial or lateral displacement, and enable the generation and maintenance of a normal range of operating pressures from about minus 50 kilopascals (-50 kPa) below ambient pressure 11 to about plus 50 kilopascals (+50 kPa) above ambient pressure 11, in light of normal anatomical variations in ear canal 6, over a normal range of operating temperatures from about 20°C (about 68°F) to about 50°C (about 122°F).

[0029] The earbuds (3) of the ear canal pressure regulating device (1) can be formed from a flexible material that can compressibly deform upon engagement with the ear canal (6), thereby allowing the earbuds (3) to sealably conform to the ear canal (6). For these particular embodiments, the earbuds (3) can be formed, molded, three-dimensionally printed, or otherwise fabricated from any of a number of different materials that allow for sealable engagement with the ear canal (6), including or consisting of silicone, foam (including polyurethane foam), polyvinyl siloxane, low durometer elastomers, or the like, or combinations thereof.

[0030] For certain embodiments, the earphones (3) can be formed from one material, such as a lower hardness elastomer. For certain other embodiments, the earphones (3) can be formed from multiple layers, such as an inner core layer having a higher hardness and surrounded by an outer layer having a lower hardness, or an inner core layer having a lower hardness and surrounded by an outer layer having a higher hardness. For still other embodiments, the flexible earphone walls can define a hollow interior space of the earphones (3), thereby allowing the flexible earphone walls to deform and allow the earphone exterior surface (7) to sealingly conform to the ear canal (6).

[0031] For certain embodiments, a portion of the earbud exterior surface (7) may taper inward as it approaches the second end (29) of the earbud (as shown in the example in FIGS. 4A-4D). As an illustrative example of a particular embodiment of this configuration, the earbud exterior surface (7) may be configured in the general form of a frustum of a cone that tapers inward as it approaches the second end (29) of the earbud (as shown in the example in FIGS. 4E-4G).

[0032] The earbud exterior surface (7) can further include a plurality of circumferential ribs (30) disposed in spaced relation between the earbud first end (31) and the earbud second end (29). The plurality of circumferential ribs (30) can each extend at a substantially uniform height from the earbud exterior surface (7). However, for those embodiments of the earbud exterior surface (7) having a conical configuration, the plurality of circumferential ribs (30) can have a rib diameter (32) that decreases as they approach the earbud second end (29) (as shown in the example of FIG. 4H). As an illustrative example, the rib diameter (32) of the first circumferential rib (33) proximate the first end (31) of the earphone can be approximately 7 centimeters, the rib diameter (32) of the last circumferential rib (34) proximate the second end (29) of the earphone can be approximately 4 centimeters, and the circumferential ribs (30) disposed between the first circumferential rib (33) and the last circumferential rib (34) each have a rib diameter (32) that decreases from the first circumferential rib (33) to the last circumferential rib (34). However, embodiments are not necessarily so limited, and the multiple circumferential ribs (30) can be configured in any of a number of different configurations adapted to insert into and sealingly engage the ear canal (6) and thus act as a barrier between ear canal pressure (10) and ambient pressure (11).

[0033] The earphone exterior surface (7) can remain sealingly engaged with the ear canal (6) due to friction between the earphone exterior surface (7) and the ear canal (6). For certain embodiments, the earphone exterior surface (7) can remain engaged with the ear canal (6) by forcibly pressing against the ear canal pressure regulating device (1) during normal operation. For other certain embodiments, a restraining element coupled to the ear canal pressure regulating device (1) can be worn around the ear (35) or head (36) to help retain the earphone (3) within the ear canal (6).

[0034] 2A and 2B, the earphone (3) can have an axial earphone bore (4) in communication between a first end (31) of the earphone and a second end (29) of the earphone. The axial earphone bore (4) proximate the first end (31) of the earphone can be fluidly coupled to a valved conduit (5) and configured to allow fluid flow (8) between the first and second ends (31) and (29) of the earphone.

[0035] Referring now primarily to Figures 5 and 6, earphone (3) may further include a tubular bolt (37) centrally disposed about axial earphone bore (4). Tubular bolt (37) may provide, whether fully or partially, communication between earphone first end (31) and earphone second end (29), and a bolt bore (38) may provide, whether fully or partially, communication between earphone first end (31) and earphone second end (29). Tubular bolt (37) may reduce or prevent deformation of axial earphone bore (4) in response to sealable engagement of earphone exterior surface (7) and ear canal (6), and may be sufficiently rigid to maintain sufficient fluid flow (8) within axial earphone bore (4) during normal use, as described above, for example, over normal ranges of operating temperatures and pressures.

[0036] The tubular bolt (37) may further include a bolt exterior surface (39) that is sized for removable insertion into the axial earphone bore (4) and provides a proper fluid-tight seal to maintain sufficient fluid flow (8) within the axial earphone bore (4) during normal use, as described above, for example, over a normal range of operating temperatures and pressures. For certain embodiments, the bolt exterior surface (39) may further include a plurality of circumferential barbs spaced along the bolt exterior surface (39) that assist in retaining the tubular bolt (37) within the axial earphone bore (4) and providing a fluid-tight seal.

[0037] For certain embodiments including a discrete tubular bolt (37), earphone (3) and tubular bolt (37) can be provided as a unitary structure, with earphone (3) molded or formed about tubular bolt (37). For certain other embodiments, earphone (3) can be formed or shaped to provide increasing stiffness as it approaches axial earphone bore (4). However, embodiments need not be so limited, and any of a number of different structures known to those skilled in the art can be utilized to provide tubular bolt (37) in fluid-tight relation with axial earphone bore (4).

[0038] 7 through 10, the ear canal pressure regulating device (1) can include a valved conduit (5) fluidly coupled to the fluid flow generator (2) and the axial earphone bore (4). For certain embodiments, the valved conduit (5) can be contained within a conduit body (41) having a configuration for removably coupling to the fluid flow generator (2) and the earphone (3), whereby the fluid flow generator (2) and the earphone (3) can be removably coupled to either the first end (42) of the conduit body or the second end (43) of the conduit body. The removably coupleable surfaces (44) of the fluid flow generator (2), earphone (3), first end (42) of the conduit body, and second end (43) of the conduit body may have a sufficiently similar configuration to allow the fluid flow generator (2) and earphone (3) to be removably coupled to either the first end (42) of the conduit body or the second end (43) of the conduit body (as shown in the example of FIG. 7), depending on whether the valved conduit (5) operates to achieve a pressure differential (9) with ear canal pressure (10) above ambient pressure (11) (as shown in the example of FIG. 5), or whether the valved conduit (5) operates to achieve a pressure differential (9) with ear canal pressure (10) below ambient pressure (11) (as shown in the example of FIG. 6).

[0039] The releasably matable surfaces (44) of the fluid flow generator (2), earphone (3), first end (42) of the conduit body, and second end (43) of the conduit body may be matably engaged. As an illustrative example, the releasably matable surfaces (44) may be configured as rotationally matable spiral threads. However, embodiments need not be so limited and may have a removably connectable surface (44) configured in any of a number of different ways that allow a conduit body (41) including a valved conduit (5) to be positioned to operably achieve a pressure differential (9) having an ear canal pressure (10) greater than ambient pressure (11) in a first configuration (45) (as shown in the example of FIG. 5), and further allow a conduit body (41) including a valved conduit (5) to be operably positioned to operably achieve a pressure differential (9) having an ear canal pressure (10) less than ambient pressure (11) in a second configuration (46) (as shown in the example of FIG. 6).

[0040] As an illustrative example, a conduit body (41) containing a valved conduit (5) can be positioned in a first configuration (45) (as shown in the example of FIG. 8) by removably coupling a first end (42) of the conduit body to a fluid flow generator (2) and a second end (43) of the conduit body to an earphone (3). Thus, fluid flow (8) can be regulated in a first direction (47) within the valved conduit (8) to operatively achieve a pressure differential (9) having an ear canal pressure (10) above ambient pressure (11) (as shown in the example of FIG. 5).

[0041] For certain embodiments, the fluid flow generator (2) can be removed from the first end (42) of the conduit body and the earphone (3) can be removed from the second end (43) of the conduit body to disassemble the first configuration (45). The conduit body (41) can be rotated without any structural modification to reverse the orientation of the first and second ends (42, 43) of the conduit body (as shown in the example of FIG. 9). The valved conduit (5) can be positioned in the second configuration (46) by removably coupling the earphone (3) to the first end (42) of the conduit body and removably coupling the fluid flow generator (2) to the second end (43) of the conduit body (as shown in the example of FIG. 10). Thus, fluid flow (8) can be regulated in the second direction (48) within the valved conduit (5) to operatively achieve a pressure differential (9) with ear canal pressure (10) below ambient pressure (11) (as shown in the example of Figure 6).

[0042] 2A, 2B, 5, and 6, the valved conduit (5) can include a first fluid flow conduit (49) in communication between a first end (50) of the first fluid flow conduit and a second end (51) of the first fluid flow conduit. For certain embodiments of the ear canal pressure regulating device (1) described herein, the first end (50) of the first fluid flow conduit is in communication with the fluid flow generator (2), and the second end (51) of the first fluid flow conduit is in communication with the axial earphone bore (4) of the earphone (3), regardless of whether the conduit body (41) is positioned in the first configuration (45) or the second configuration (46).

[0043] The first fluid flow conduit (49) can be blocked by a first valve (52) to regulate fluid flow (8) unidirectionally between first and second ends (50, 51) of the first fluid flow conduit, and correspondingly, between the fluid flow generator (2) and the axial earphone bore (4). In the aforementioned first configuration (45), the fluid flow generator (2) can be sealably engaged with the first end (50) of the first fluid flow conduit, and the axial earphone bore (4) can be sealably engaged with the second end (51) of the first fluid flow conduit, to regulate fluid flow (8) unidirectionally in a first direction (47) from the fluid flow generator (2) toward the axial earphone bore (4). Thus, the ear canal pressure regulating device (1) sealably engaged with the ear canal (6) can operatively achieve a pressure differential (9) having an ear canal pressure (10) above ambient pressure (11) by transferring a fluid volume (12) from the fluid flow generator (2) toward the ear canal (6). In the aforementioned second configuration (46), the fluid flow generator (2) can be sealably engaged with the first end (50) of the first fluid flow conduit, and the axial earphone bore (4) can be sealably 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 earphone bore (4) toward the fluid flow generator (2). Thus, the ear canal pressure regulating device (1), which is sealably engaged with the ear canal (6), can operatively achieve a pressure differential (9) having an ear canal pressure (10) below ambient pressure (11) by transferring a fluid volume (12) from the ear canal (6) toward the fluid flow generator (2).

[0044] 2A, 2B, 5, and 6, the first valve (52) can divide the first fluid-flow conduit (49) into a first portion (53) proximate the first end (50) of the first fluid-flow conduit and correspondingly proximate the fluid flow generator (2), and a second portion (54) proximate the second end (51) of the first fluid-flow conduit and correspondingly proximate the axial earphone bore (4) of the earphone (3). For certain embodiments, the valved conduit (5) can further include a second fluid-flow conduit (55) fluidly coupled between the first portion (53) of the first fluid-flow conduit (49) and ambient pressure (11). For certain embodiments of the ear canal pressure regulating device (1) described herein, the second fluid flow conduit (55) is fluidly coupled to a first portion (53) of the first fluid flow conduit (49) proximate the fluid flow generator (2), regardless of whether the conduit body (41) is positioned in the first configuration (45) or the second configuration (46). The second fluid flow conduit (55) can be blocked by a second valve (56) to regulate the fluid flow (8) in one direction within the second fluid flow conduit (55).

[0045] Referring now primarily to FIGS. 2A and 5, with respect to a particular embodiment of first configuration (45) having fluid flow generator (2) including volume-adjustable element (13) having interior volume (19) bounded by elastically flexible wall (16), a deformed state (20) of elastically flexible wall (16) can reduce interior volume (19) and generate fluid flow (8) in first direction (47) within first fluid flow conduit (49) from fluid flow generator (2) toward axial earphone bore (4) of earphone (3), whereby first valve (52) and second valve (56) unidirectionally regulate fluid flow (8) out of axial earphone bore (4). Thus, the ear canal pressure regulating device (1), which is sealably engaged with the ear canal (6), can operatively achieve a pressure differential (9) having an ear canal pressure (10) that exceeds ambient pressure (11) by transferring a fluid volume (12) from the fluid flow generator (2) toward the ear canal (6).

[0046] The elastically flexible wall (16) of the volume-adjustable element (13) can return to an undeformed state (21), which can increase the internal volume (19) and generate fluid flow (8) in the second fluid flow conduit (55), whereby the second valve (56) regulates the fluid flow (8) in one direction, from ambient pressure (11) toward the fluid flow generator (2). The first valve (52) can block the fluid flow (8) in the first fluid flow conduit (49) from the axial earphone bore (4) toward the fluid flow generator (2). An embodiment of the ear canal pressure regulating device (1) that is sealingly engaged with the ear canal (6) can operatively maintain a pressure differential (9) such that ear canal pressure (10) can be maintained above ambient pressure (11), and in parallel can transfer a fluid volume (12) from ambient pressure (11) toward the fluid flow generator (2) and return the elastically flexible wall (16) of the volume-adjustable element (13) to an undeformed state (21).

[0047] Referring now primarily to Figures 2B and 6, with respect to a particular embodiment of second configuration (46) having fluid flow generator (2) including volume-adjustable element (13) having internal volume (19) bounded by elastically flexible wall (16), a deformed state (20) of elastically flexible wall (16) reduces internal volume (19) and generates fluid flow (8) in second fluid flow conduit (55) from fluid flow generator (2) toward ambient pressure (11), whereby first valve (52) and second valve (56) can unidirectionally adjust fluid flow (8) from second fluid flow conduit (55) toward ambient pressure (11).

[0048] The elastically flexible wall (16) of the volume-adjustable element (13) can return to an undeformed state (21) that can increase the interior volume (19) and generate fluid flow (8) in a second direction (48) within the first fluid flow conduit (49), whereby the first valve (52) regulates fluid flow (8) in one direction, from the axial earphone bore (4) of the earphone (3) toward the fluid flow generator (2). The second valve (56) can block fluid flow (8) in the second fluid flow conduit (55) from ambient pressure (11) toward the fluid flow generator (2). Thus, the ear canal pressure regulating device (1), which is sealingly engaged with the ear canal (6), can operatively achieve and maintain a pressure differential (9) that allows the ear canal pressure (10) to be maintained below the ambient pressure (11), and in parallel can transport a fluid volume (12) from the ear canal (6) toward the fluid flow generator (2) and return the elastically flexible wall (16) of the volume-adjustable element (13) to its undeformed state (21).

[0049] 2A, 2B, 5, and 6, for certain embodiments, the valved conduit (5) may further include a third fluid-flow conduit (57) fluidly coupled between the second portion (54) of the first fluid-flow conduit (49) and ambient pressure (11). For certain embodiments 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) proximate the axial earphone bore (4), regardless of whether the conduit body (41) is positioned in the first configuration (45) or the second configuration (46).

[0050] The third fluid flow conduit (57) can be blocked by a third valve (58) to regulate fluid flow (8) in one direction within the third fluid flow conduit (57). For certain embodiments, the third valve (58) can regulate fluid flow (8) out of the third fluid flow conduit (57) toward ambient pressure (11). For other certain embodiments, the third valve (58) can regulate fluid flow (8) into the third fluid flow conduit (57) from ambient pressure (11).

[0051] For certain embodiments, the third valve (58) can block fluid flow (8) in the third fluid flow conduit (57) until the pressure differential (9) between the second portion (54) of the first fluid flow conduit (49) and ambient pressure (11) exceeds a preselected pressure differential (9), typically having a pressure differential amplitude (59) in the range of 0 kilopascals to about 50 kilopascals. However, embodiments can have a lesser or greater preselected pressure differential amplitude (59) depending on the application. For certain embodiments, the preselected pressure differential amplitude (59) may be between 0 kilopascals and about 5 kilopascals, between about 2.5 kilopascals and about 7.5 kilopascals, between about 5 kilopascals and about 10 kilopascals, between about 7.5 kilopascals and about 12.5 kilopascals, between about 10 kilopascals and about 15 kilopascals, between about 12.5 kilopascals and about 17.5 kilopascals, between about 15 kilopascals and about 20 kilopascals, between about 17.5 kilopascals and about 22.5 kilopascals, between about 20 kilopascals and about 25 kilopascals, between about 22.5 kilopascals and about 27 kilopascals, or between about 27 kilopascals and about 30 kilopascals. The pressure may be selected from the group including or consisting of: about 0.5 kilopascals, about 25 kilopascals to about 30 kilopascals, about 27.5 kilopascals to about 32.5 kilopascals, about 30 kilopascals to about 35 kilopascals, about 32.5 kilopascals to about 37.5 kilopascals, about 35 kilopascals to about 40 kilopascals, about 37.5 kilopascals to about 42.5 kilopascals, about 40 kilopascals to about 45 kilopascals, about 42.5 kilopascals to about 47.5 kilopascals, and about 45 kilopascals to about 50 kilopascals.

[0052] Depending on the method of use, one or more preselected pressure differential amplitudes (59) can be generated using the ear canal pressure regulating device (1), which may be further influenced by factors such as the anatomy, physiology, or biochemistry of the user (23) of the ear canal (24); the target disorder symptoms to be alleviated; the target disorder to be treated; the observable effects of using one or more preselected pressure differential amplitudes (59) in the particular method of use of the ear canal pressure regulating device (1); or the like; or a combination thereof, but not to an extent that causes discomfort to the user (23) or damage to the ear canal (24) or tympanic membrane (25).

[0053] Referring now primarily to Figures 2A and 2B, the valved conduit (5) includes a fluid flow manifold (60) that can be shut off by operation of one or more valves (61), e.g., a first valve (52), a second valve (56), a third valve (58), or additional valves (61), to correspondingly alter the configuration of manifold fluid flow paths (62) within the fluid flow manifold (60) and regulate the fluid flow (8) within the fluid flow manifold (60). Although the figures diagrammatically illustrate particular configurations of fluid flow manifolds (60), which correspondingly define particular configurations of manifold fluid flow paths (62), these embodiments need not be so limited with respect to the configuration of the fluid flow manifolds (60) or manifold fluid flow paths (62) of the valved conduits (5), and embodiments may be formed, molded, three-dimensionally printed, or otherwise fabricated as a unitary structure, or assembled from multiple pieces into which first, second, or third valves (52), (56), (58) (or additional valves (61)) may be arranged, assembled, or otherwise coupled to create the valved conduits (5). The conduit body (41) may include any of a number of different configurations that may fluidly couple first, second, or third fluid flow conduits (49), (55), (57) (or additional fluid flow conduits) as described above, whether defined by a plurality of discrete conduits, an integral manifold, or the like, including, but not limited to, the conduit body (41) configurations shown in the illustrative embodiments of Figures 4A through 6 that may be injection molded as a one-piece conduit body (41) that may center around or receive first, second, or third valves (52), (56), (58) (or additional valves).

[0054] Referring now primarily to FIGS. 3A through 3E, the first, second, or third valves (52), (56), and (58) shown diagrammatically in FIGS. 2A and 2B may have any type of valve configuration capable of regulating fluid flow (8), as described herein, and may include, but are not limited to, a spring-loaded ball check valve (63) (as shown in the example of FIG. 3C), a flapper valve (64) having a hinge (94) (as shown in the example of FIG. 3B), a spring-loaded valve having a valve seat and a seatable deformable circular edge (65) (as shown in the example of FIG. 3A), an umbrella valve (66) (as shown in the example of FIG. 3D), a duckbill valve (67) (as shown in the example of FIG. 3E), or other valves (61) operable between a closed state (68) and an open state (69) to unidirectionally regulate fluid flow (8) within a preselected range.

[0055] For certain embodiments, each of the first, second, or third valves (52), (56), (58) can be operable between a closed state (68), which can be substantially leak-proof against reverse flow and substantially leak-proof against forward fluid flow (8), up to a pressure differential amplitude (59) of approximately 50 kilopascals across the valve (61), and an open state (69), which can have a forward flow rate within a range of approximately 0.2 milliliters per second to approximately 20 milliliters per second. For certain embodiments, the pressure differential (9) across the valve (61) or the forward fluid flow (8) in the open state (69) of the valve (61) can be regulated by the configuration of the valve (61), the unrestricted cross-sectional area of ​​the manifold fluid flow path (62), or the like, or a combination thereof. Additionally, while the disclosed examples of the ear canal pressure regulating device (1) can generate a pressure difference amplitude (59) between the ear canal pressure (10) and the ambient pressure (11) of up to 50 kilopascals, these examples are not intended to teach or suggest that all embodiments of the ear canal pressure regulating device (1) necessarily achieve this pressure difference amplitude (59) between the ear canal pressure (10) and the ambient pressure (11). Rather, particular embodiments of the ear canal pressure regulating device (1) can be configured to achieve a pressure difference (9) between the ear canal pressure (10) and the ambient pressure (11) based on its effectiveness in alleviating one or more disorder symptoms, e.g., neurally mediated pain, or treating one or more disorders, e.g., craniofacial pain syndrome or headache syndrome.

[0056] 5, 6, and 11A-12D, for certain embodiments, the valve (61) can be operably coupled to a pressure relief element (70) configured to allow manual operation of the valve (61) between a closed state (68) and an open state (69). As an illustrative example, the pressure relief element (70) can be operable to allow ear canal pressure (10) to return to ambient pressure (11), whether from an ear canal pressure (10) above ambient pressure (11) or an ear canal pressure (10) below ambient pressure (11). For certain embodiments, the pressure relief element (70) may be operable to allow a fluid volume (12) to flow from a portion of the valved conduit (5) toward ambient pressure (11) or from ambient pressure (11) toward a portion of the valved conduit (5) in response to achieving or exceeding a preselected threshold ear canal pressure (10), thereby reducing discomfort to the user (23) or risk of injury to the ear canal (24) or eardrum (25).

[0057] For certain embodiments, pressure relief element 70 can be configured to extend outward from conduit body 41 a sufficient distance to allow for gripping engagement by user 23. For other certain embodiments, pressure relief element 70 can be configured as a resiliently flexible portion of conduit body 41 that can flex in response to pressing engagement to place valve 61 in open state 69. In response to disengagement of pressure relief element 70, valve 61 can return to closed state 68.

[0058] 5, 6, and 11A-12D, for certain embodiments, a second valve pressure relief element (71) can be coupled to the second valve (56), and a third valve pressure relief element (72) can be coupled to the third valve (58). The second and third valve pressure relief elements (71)(72) can each be manually operable to generate fluid flow (8) in the second or third fluid flow conduits (55)(57), respectively.

[0059] 11A through 12D, for certain embodiments, the ear canal pressure regulating device (1) can be configured to achieve an ear canal pressure (10) that may be below or above ambient pressure (11). The effective amount of ear canal pressure (10) to alleviate one or more disorder symptoms or treat one or more disorders, or the maximum amount of ear canal pressure (10) achieved within a pressure regulation profile (73) generated by an embodiment of the ear canal pressure regulating device (1), can range from pressures slightly above or below ambient pressure (11) to pressures slightly above or below ear canal pressure (10) that may cause discomfort to the user (23) or injury to the ear canal (24) or tympanic membrane (25). While authorities have differing views regarding ear canal pressures (10) that may result in discomfort to the user (23) or damage to the ear canal (24) or eardrum (25), typically, embodiments of ear canal pressure regulating devices (1) will not be configured to operate below about -50 kilopascals below ambient pressure (11) or above about +50 kilopascals above ambient pressure (11).

[0060] 2A, 5, and 11A-11D, for certain embodiments, ear canal pressure regulating device (1) can be configured to achieve an ear canal pressure (10) that can exceed ambient pressure (11). Thus, in a first configuration (45), valved conduit (5) is coupled to fluid flow generator (2) and axial earphone bore (4) of earphone (3) and can unidirectionally regulate fluid flow (8) in first direction (47) within first fluid flow conduit (5) so as to exit axial earphone bore (4) toward ear canal (6).

[0061] 11A and 11B, the earbud exterior surface (7) of the earbud (3) can be sealingly engaged with the ear canal (6), as previously described. Operation of the fluid flow generator (2) can compress the amount of fluid (74) within the first portion (53) of the first fluid flow conduit (49). For those embodiments including a volume-adjustable element (13), the elastically flexible wall (16) can be deformed, reducing the interior volume (19) of the volume-adjustable element (13), compressing the amount of fluid (74) within the first portion (53) of the first fluid flow conduit (49), and creating a pressure differential (9) across the first valve (52) and the second valve (56). For those embodiments including a piston (27) reciprocating within a barrel (28), the piston (27) may advance within the barrel (28) and reduce the barrel's internal volume, thus creating a pressure differential (9) across the first valve (52) and the second valve (56). Regardless of the configuration of the fluid flow generator (2), the pressure differential (9) across the first valve (52) may be such that the fluid pressure (75) within the first portion (53) of the first fluid flow conduit (49) may exceed the fluid pressure (75) within the second portion (54) of the first fluid flow conduit (49). This pressure differential (9) may be sufficient to generate an open state (69) of the first valve (52). The pressure differential (9) across the second valve (56) may be such that the fluid pressure (75) within the first portion (53) of the first fluid-flow conduit (49) may exceed the ambient pressure (11), which may be sufficient to cause the second valve (56) to close (68). The open state (69) of the first valve (52) and the closed state (68) of the second valve (56) may result in a fluid flow (8) within the first fluid-flow conduit (49) in the first direction (47), flowing from the fluid flow generator (2) through the axial earphone bore (4) and out the second end (29) of the earphone into the ear canal (6), thus increasing the ear canal pressure (10) above the ambient pressure (11).

[0062] 11C, continued operation of the fluid flow generator (2) can further act to reduce the pressure differential (9) across the first valve (52) and the second valve (56), for example, by allowing the resiliently flexible wall (16) of the volume-adjustable element (13) to return to its undeformed state (21). The pressure differential (9) across the first valve (52) can be such that the fluid pressure (75) in the first portion (53) of the first fluid-flow conduit (49) can be less than the fluid pressure (75) in the second portion (54) of the first fluid-flow conduit (49). This pressure difference (9) is sufficient to cause the first valve (52) to enter a closed state (68), thus blocking the fluid flow (8) in the first fluid flow conduit (49) from the axial earphone bore (4) toward the fluid flow generator (2), thereby correspondingly maintaining the pressure difference (9) between the ear canal pressure (10) and the ambient pressure (11).

[0063] 11C , a continued decrease in fluid pressure (75) within the first portion (53) of the first fluid flow conduit (49) can create a pressure differential (9) across the second valve (56) such that the fluid pressure (75) within the first portion (53) of the first fluid flow conduit (49) can fall below ambient pressure (11), which can be sufficient to generate an open state (69) of the second valve (56). Thus, a fluid flow (8) can be generated from ambient pressure (11) through the second fluid flow conduit (55) toward the fluid flow generator (2). For those embodiments having a volume-adjustable element (13), the fluid flow (8) from ambient pressure (11) toward the fluid flow generator (2) can allow the elastically flexible wall (16) to return to its undeformed state (21) by increasing its internal volume (19). For those embodiments having a piston (27) reciprocating within the barrel (28), fluid flow (8) from ambient pressure (11) through the second fluid flow conduit (55) toward the fluid flow generator (2) can allow the piston (27) to return to a location within the barrel (28) increasing the barrel's internal volume.

[0064] 11D, the third valve (58) in the closed state (68) can remain substantially leak-proof to fluid flow (8) in the third fluid flow conduit (57) up to a pressure differential amplitude (59) of approximately 50 kilopascals between the ear canal pressure (10) and the ambient pressure (11). Thus, the ear canal pressure regulating device (1) can be operated to achieve a desired ear canal pressure (10) above the ambient pressure (11), or to achieve an ear canal pressure (10) above a preselected ambient pressure (11), beyond which the third valve (58) is brought into an open state (69), allowing fluid flow (8) from the ear canal pressure (10) toward the ambient pressure (11) to maintain the desired or preselected ear canal pressure (10).

[0065] Referring now primarily to Figures 5 and 11D, the third valve (58) can be operably coupled to a third valve pressure relief element (72) configured to enable manual operation of the third valve (58) between a closed state (68) and an open state (69) and to facilitate return of ear canal pressure (10) to ambient pressure (11).

[0066] 2B, 6, and 12A-12D, for certain embodiments, ear canal pressure regulating device (1) can be configured to achieve an ear canal pressure (10) that can be below ambient pressure (11). Thus, valved conduit (5) can be coupled to fluid flow generator (2) and axial earphone bore (4) of earphone (3) in second configuration (46) to regulate fluid flow (8) unidirectionally in a second direction (48) within first fluid flow conduit (49) from ear canal (6) toward fluid flow generator (2) and into axial earphone bore (4).

[0067] As shown in Figures 12A and 12B, the earbud exterior surface (7) of the earbud (3) can be sealingly engaged with the ear canal (6), as previously described. Operation of the fluid flow generator (2) can compress the amount of fluid (74) within the first portion (53) of the first fluid flow conduit (49). For those embodiments including a volume-adjustable element (13), the elastically flexible wall (16) can be deformed, reducing the interior volume (19) of the volume-adjustable element (13), compressing the amount of fluid (74) within the first portion (53) of the first fluid flow conduit (49), and creating a pressure differential (9) across the first valve (52) and the second valve (56). For those embodiments including a piston (27) reciprocating within a barrel (28), the piston (27) may advance within the barrel (28) and reduce the barrel's internal volume, thus creating a pressure differential (9) across the first valve (52) and the second valve (56). Regardless of the configuration of the fluid flow generator (2), the pressure differential (9) across the first valve (52) may be such that the fluid pressure (75) within the first portion (53) of the first fluid flow conduit (49) may exceed the fluid pressure (75) within the second portion (54) of the first fluid flow conduit (49). This pressure differential (9) may be sufficient to cause the first valve (52) to enter a closed state (68). The pressure differential (9) across the second valve (56) may be such that the fluid pressure (75) within the first portion (53) of the first fluid flow conduit (49) may exceed the ambient pressure (11), which may be sufficient to cause an open state (69) of the second valve (56), which may generate a fluid flow (8) within the second fluid flow conduit (55) from the fluid flow generator (2) toward the ambient pressure (11).

[0068] As shown in FIG. 12C , the continued operation of the fluid flow generator (2) can further act to reduce the pressure differential (9) across the first valve (52) and the second valve (56), for example, by allowing the elastically flexible wall (16) of the volume-adjustable element (13) to return to its undeformed state (21). The pressure differential (9) across the first valve (52) can be such that the fluid pressure (75) in the first portion (53) of the first fluid-flow conduit (49) can be less than the fluid pressure (75) in the second portion (54) of the first fluid-flow conduit (49). This pressure differential (9) can be sufficient to generate an open state (69) of the first valve (52), which can result in fluid flow (8) from the ear canal (6) toward the fluid flow generator (2), thus reducing the ear canal pressure (10) below ambient pressure (11).

[0069] Referring again to FIG. 12C , a continued decrease in fluid pressure (75) within first portion (53) of first fluid flow conduit (49) can result in a pressure differential (9) across second valve (56) such that fluid pressure (75) within first portion (53) of first fluid flow conduit (49) can fall below ambient pressure (11), sufficient to cause second valve (56) to close (68), thus blocking fluid flow (8) within second fluid flow conduit (55) from fluid flow generator (2) toward ambient pressure (11), and correspondingly maintaining a pressure differential (9) between ear canal pressure (10) and ambient pressure (11).

[0070] For those embodiments having a volume-adjustable element (13), fluid flow (8) from the ear canal (6) toward the fluid flow generator (2) can allow the elastically flexible wall (16) to return to its undeformed state (21) by increasing the internal volume (19). For those embodiments having a piston (27) reciprocating within the barrel (28), fluid flow (8) from the ear canal (6) toward the fluid flow generator (2) through the first fluid flow conduit (49) can allow the piston (27) to return to a location within the barrel (28) increasing the barrel's internal volume.

[0071] 12D, the third valve (58) in the closed state (68) can remain substantially leak-proof to fluid flow (8) in the third fluid flow conduit (57) up to a pressure differential amplitude (59) of approximately 50 kilopascals between the ear canal pressure (10) and ambient pressure (11). Thus, the ear canal pressure regulating device (1) can be operated to achieve a desired ear canal pressure (10) below ambient pressure (11), or to achieve a preselected ear canal pressure (10) below ambient pressure (11), above which it will cause the third valve (58) to return to the open state (69) and allow fluid flow (8) from ambient pressure (11) toward the ear canal (6) to maintain the desired or preselected ear canal pressure (10).

[0072] Referring now primarily to Figures 6 and 12D, the third valve (58) can be operably coupled to a third valve pressure relief element (72) configured to enable manual operation of the third valve (58) between a closed state (68) and an open state (69) and to facilitate return of the ear canal pressure (10) to ambient pressure (11).

[0073] 13A through 13F, certain embodiments of an ear canal pressure regulating device (1) can include a fluid flow generator (2) configured as a diaphragm (15) having an elastically flexible wall (16) with an outer wall surface (17) and an inner wall surface (18) (whether fully or partially as an assembly with a valved conduit (5)) that defines an interior volume (19). The elastically flexible wall (16) in a deformed state (20) can decrease the interior volume (19), and alternatively, when moving toward an undeformed state (21), the interior volume (19) can increase. The change in the interior volume (19) can generate a fluid flow (8) between the fluid flow generator (2) and the axial earphone bore (4) of the earphone (3), which can be regulated by the valved conduit (5).

[0074] 13A-13F, the ear canal pressure regulating device (1) can include a valved conduit (5) fluidly coupled between the fluid flow generator (2) and the axial earbud bore (4). For certain embodiments, the earbud (3) having the axial earbud bore (4) and first, second, and third fluid flow conduits (49), (55), and (57) can be contained within a conduit body (41) configured to removably couple to the fluid flow generator (2) and first, second, and third valves (52), (56), and (58). For certain embodiments, the first and second valves (52)(56) can be included in a first valve assembly (83) that is fluidly coupled between the fluid flow generator (2) and the first and second fluid flow conduits (49)(55) and can block the fluid flow (8) between the fluid flow generator (2) and the first and second fluid flow conduits (49)(55), thereby unidirectionally regulating the fluid flow (8) in the first and second fluid flow conduits (49)(55).

[0075] The third valve (58) can be included in a second valve assembly (84), which is fluidly coupled to the third fluid flow conduit (57), communicates between the first fluid flow conduit (49) and ambient pressure (11), and blocks fluid flow (8) between the third fluid flow conduit (57) and ambient pressure (11), thereby regulating fluid flow (8) in one direction within the third fluid flow conduit (57) between the first fluid flow conduit (49) and ambient pressure (11). For certain embodiments, the fluid flow generator (2) and the first and second valve assemblies (83)(84) can be provided as an integral structure. For other certain embodiments, the fluid flow generator (2), the first valve assembly (83), and the second valve assembly (84) can be provided as multiple parts that can be assembled into a configuration that is removably connectable to the conduit body (41).

[0076] For certain embodiments, the first and second valves (52)(56) contained within the first valve assembly (83) can have any type of valve configuration operable between a closed state (68) and an open state (69) to unidirectionally regulate fluid flow (8) within a preselected range, as described above. As an illustrative example, both the first and second valves (52)(56) contained within the first valve assembly (83) can be configured as flapper valves (64) having hinges (94) with opposing configurations (as shown in the examples of Figures 3B and 13C-13F).

[0077] For certain embodiments, the second valve assembly (84) can be operable to allow ear canal pressure (10) to return to ambient pressure (11). The second valve assembly (84) can include an elastically deformable annular member (85) and a pressure relief element (70) configured to deform the elastically deformable annular member (85) as a deformable deformation member (86). The elastically deformable annular member (85) can have an annular member outer surface (87) disposed adjacent to, and capable of sealingly engaging, a conduit inner surface (88) of the first fluid-flow conduit (49).

[0078] An annular member opening element (89) communicating between the annular member inner surface (90) and the annular member outer surface (87) can be aligned with the axial earphone bore (4) to form a through-hole (91) between the first fluid-flow conduit (49) and the axial earphone bore (4). The deformable member (86) can be disposed through the third fluid-flow conduit (57) communicating between the first fluid-flow conduit (49) and ambient pressure (11) such that a first end (92) of the deformable member can extend outward from the third fluid-flow conduit (57) and the conduit body (41) and a second end (93) of the deformable member can deformably engage the annular member outer surface (87). In response to the gripping engagement of the first end (92) of the deformable member, the deformable member (86) can be urged towards and deform the elastically deformable annular member (85) such that the annular member outer surface (87) disengages from the conduit inner surface (88) of the first fluid-flow conduit (49), thereby positioning the third valve (58) in an open state (69) and allowing fluid flow (8) to flow between the axial earphone bore (4), the first and third fluid-flow conduits (49) (57), and ambient pressure (11). Thus, the third valve (58) in the open state (69) allows fluid flow (8) to occur between the ear canal (6) and ambient pressure (11) and return ear canal pressure (10) to ambient pressure (11), whether from an ear canal pressure (10) above ambient pressure (11) or an ear canal pressure (10) below ambient pressure (11).

[0079] The fluid flow generator (2), the first valve assembly (83), and the second valve assembly (84) can be removably coupled to the conduit body (41) in either a first configuration (45) or a second configuration (46). The removably coupleable surfaces (44) of the conduit body (41), fluid flow generator (2), first valve assembly (83), and second valve assembly (84) can have a sufficiently similar configuration to allow the conduit body (41) to be removably coupled to the fluid flow generator (2), first valve assembly (83), and second valve assembly (84) in either a first configuration (45) or a second configuration (46), depending on whether the valved conduit (5) operates to achieve a pressure differential (9) with ear canal pressure (10) above ambient pressure (11) (as shown in the example of FIG. 13E) or whether the valved conduit (5) operates to achieve a pressure differential (9) with ear canal pressure (10) below ambient pressure (11) (as shown in the example of FIG. 13F). For certain embodiments, the removably coupleable surfaces (44) of the conduit body (41), the fluid flow generator (2), the first valve assembly (83), and the second valve assembly (84) can be matably engaged to removably couple.

[0080] For the particular embodiment of the ear canal pressure regulating device (1) described herein, the first and second valves (52)(56) fluidly couple to the corresponding first and second fluid flow conduits (49)(55) and block the fluid flow (8) within the corresponding first and second fluid flow conduits (49)(55), regardless of whether the conduit body (41) may be positioned in the first configuration (45) or the second configuration (46).

[0081] 13E , as an illustrative example, fluid flow generator (2), first valve assembly (83), and conduit body (41) can be positioned in first configuration (45) by removably coupling fluid flow generator (2) and first valve assembly (83) to conduit body (41). In first configuration (45), first valve (52) can be operable to unidirectionally regulate fluid flow (8) within first fluid-flow conduit (49), such that in open state (69), first valve (52) allows fluid flow (8) to flow from fluid flow generator (2) toward axial earphone bore (4), and in closed state (68), prevents fluid flow (8) from flowing between fluid flow generator (2) and axial earphone bore (4). Thus, fluid flow (8) generated by deforming elastically flexible wall (16) of diaphragm (15) and reducing internal volume (19) can be regulated in first direction (47) within first fluid flow conduit (49) to flow out of axial earphone bore (4) toward ear canal (6), thereby achieving a pressure differential (9) having ear canal pressure (10) above ambient pressure (11). Upon achieving a desired pressure differential (9) between ear canal pressure (10) and ambient pressure (11), elastically flexible wall (16) of diaphragm (15) can return to undeformed state (21), thereby closing first valve (52) and preventing fluid flow (8) from flowing out of axial earphone bore (4) toward fluid flow generator (2), thereby allowing the desired pressure differential (9) to be maintained.

[0082] In the first configuration (45), the second valve (56) can be operable to regulate fluid flow (8) in one direction within the second fluid flow conduit (55), such that in an open state (69), the second valve (56) allows fluid flow (8) to flow from ambient pressure (11) toward the fluid flow generator (2), and in a closed state (68), the second valve (56) prevents fluid flow (8) from flowing between the ambient pressure (11) and the fluid flow generator (2).

[0083] Thus, the fluid flow (8) generated in response to the return of the elastically flexible wall (16) of the diaphragm (15) to its undeformed state (21) and the increase in internal volume (19) can be regulated within the second fluid flow conduit (55) to flow from the ambient pressure (11) toward the fluid flow generator (2), thereby allowing the desired pressure differential (9) between the ear canal pressure (10) and the ambient pressure (11) to be maintained while allowing the elastically flexible wall (16) of the diaphragm (15) to return to its undeformed state (21).

[0084] For certain embodiments, the fluid flow generator (2), first valve assembly (83), and conduit body (41) in the first configuration (45) may further include a second valve assembly (84) fluidly coupled to a third fluid flow conduit (57) communicating between the first fluid flow conduit (49) and ambient pressure (11) and positioned such that the third valve (58) can unidirectionally regulate fluid flow (8) within the third fluid flow conduit (57) between the first fluid flow conduit (49) and ambient pressure (11). In its open state (69), the third valve (58) allows fluid flow (8) from the axial earphone bore (4) through the first and third fluid flow conduits (49) (57) toward ambient pressure (11), and in its closed state (68) prevents fluid flow (8) from flowing between the axial earphone bore (4) and ambient pressure (11). Thus, in its open state (69), the third valve (58) allows fluid flow (8) from the ear canal (6) toward ambient pressure (11) and can return ear canal pressure (10) to ambient pressure (11).

[0085] For certain embodiments, the fluid flow generator (2), first valve assembly (83), and second valve assembly (84) can be removed from the conduit body (41) to disassemble the first configuration (45). The first valve assembly (83) can be rotated relative to the conduit body (41) without any structural modification to the reverse orientation of the first valve assembly (83), thereby achieving the second configuration (46).

[0086] 13F, as an illustrative example, the fluid flow generator (2), first valve assembly (83), and conduit body (41), as previously described, can be positioned in the second configuration (46). In the second configuration (46), the second valve (56) can be operable to unidirectionally regulate fluid flow (8) in the second fluid flow conduit (55), such that in the open state (69), the second valve (56) allows fluid flow (8) to flow from the fluid flow generator (2) toward ambient pressure (11), and in the closed state (68), prevents fluid flow (8) from flowing between the fluid flow generator (2) and ambient pressure (11). Thus, fluid flow (8) generated by deforming the elastically flexible wall (16) of the diaphragm (15) and reducing the internal volume (19) can be regulated within the second fluid flow conduit (55) to flow out of the second fluid flow conduit (55) toward ambient pressure (11). The elastically flexible wall (16) of the diaphragm (15) can be allowed to return to its undeformed state (21), thereby closing the second valve (56) and preventing fluid flow (8) from flowing between the fluid flow generator (2) and ambient pressure (11).

[0087] In the second configuration (46), the first valve (52) can be operable to regulate fluid flow (8) unidirectionally within the first fluid flow conduit (49), such that in the open state (69), the first valve (52) allows fluid flow (8) to flow from the axial earphone bore (4) toward the fluid flow generator (2), and in the closed state (68), the first valve (52) prevents fluid flow (8) from flowing between the axial earphone bore (4) and the fluid flow generator (2).

[0088] Thus, fluid flow (8) generated in response to the return of the resiliently flexible wall (16) of the diaphragm (15) to the undeformed state (21) and the increase in internal volume (19) is regulated in the first fluid flow conduit (56) in the second direction (48) so as to flow from the ear canal (6) into the axial earphone bore (4) toward the fluid flow generator (2), thereby achieving a pressure differential (9) having an ear canal pressure (10) below ambient pressure (11). In response to achieving the desired pressure differential (9) between the ear canal pressure (10) and ambient pressure (11), the first valve (52) returns to the closed state (68), preventing fluid flow (8) from flowing between the axial earphone bore (4) and the fluid flow generator (2), thereby maintaining the desired pressure differential (9) between the ear canal pressure (10) and ambient pressure (11).

[0089] For certain embodiments, the fluid flow generator (2), first valve assembly (83), and conduit body (41) in the second configuration (46) can further include a second valve assembly (84) fluidly coupled to a third fluid flow conduit (57) communicating between the first fluid flow conduit (49) and ambient pressure (11) and positioned to unidirectionally regulate fluid flow (8) in the third fluid flow conduit (57) between the first fluid flow conduit (49) and ambient pressure (11). In the open state (69), the third valve (58) allows fluid flow (8) from ambient pressure (11) through the third and first fluid flow conduits (57) (49) toward the axial earphone bore (4), and in the closed state (68), prevents fluid flow (8) from flowing between the ambient pressure (11) and the axial earphone bore (4). Thus, the third valve (58) in the open state (69) can generate a fluid flow (8) from ambient pressure (11) towards the ear canal (6) and return ear canal pressure (10) to ambient pressure (11).

[0090] Reference is now made primarily to Figures 14A through 15G, which illustrate the pressure difference (9) between ear canal pressure (10) and ambient pressure (11) achieved over a time period (76) by operation of an embodiment of an ear canal pressure regulating device (1). For certain embodiments, a fluid flow generator (2) comprising a volume-adjustable element (13) can be operated from an undeformed state (21) toward a deformed state (20) to generate a fluid flow (8) in a first direction (47) over the time period (76) that flows out of the axial earphone bore (4) toward the ear canal (6) and results in a positive ear canal pressure (10) relative to ambient pressure (11) (as shown in the example of Figures 14A through 14G). For other specific embodiments, the fluid flow generator (2), comprising the volume-adjustable element (13), can be operated from a deformed state (20) toward an undeformed state (21) to generate a fluid flow (8) in a second direction (48) over a time period (76) that flows axially from the ear canal (6) toward the fluid flow generator (2) and into the earphone bore (4), resulting in a negative ear canal pressure (10) relative to ambient pressure (11) (as shown in the example of Figures 15A-15G).

[0091] 14A and 15A, the fluid flow generator (2) can be operated to maintain a constant pressure amplitude (77) over a time period (76). For certain embodiments, the constant pressure amplitude (77) can be maintained over the time period (76) without substantially any fluid flow (8) of the fluid volume (12) within the ear canal (6). As an illustrative example, an ear canal pressure regulating device (1), having an earbud exterior surface (7) sealably engaged with the ear canal (6) as described above, 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 ear canal (6) through the axial earbud bore (4) of the earbud (3), thereby achieving a pressure differential (9) between the ear canal pressure (10) and ambient pressure (11). Once the desired pressure differential (9) between the ear canal pressure (10) and the ambient pressure (11) is achieved, the pressure amplitude (77) can be maintained for a time period (76) without additional fluid flow (8) of the fluid volume (12), for example, by operation of the first valve (52) configured to allow unidirectional fluid flow (8) of the fluid volume (12) through the first fluid flow conduit (49) such that the fluid volume (12) can only either flow into or out of the ear canal (6). For other embodiments, once the desired pressure differential (9) between the ear canal pressure (10) and the ambient pressure (11) is achieved, the pressure amplitude (77) can be maintained for a time period (76) by additional fluid flow (8) of the fluid volume (12) into or out of the ear canal (6) to manipulate leakage around the engagement of the earphone exterior surface (7) and the ear canal (6). For other embodiments, the pressure amplitude (77) can be maintained for a time period (76) by a continuous fluid flow (8) of the fluid volume (12) within the ear canal (6).

[0092] The constant pressure amplitude (77) can be maintained over a time period (76) to alleviate disorder symptoms or treat the disorder, whereby the constant pressure amplitude (77) can be within a range from about +50 kilopascals above ambient pressure (11) to about -50 kilopascals below ambient pressure (11). A positive ear canal pressure (10) relative to ambient pressure (11) can be achieved by maintaining the constant pressure amplitude (77) within a range from about 0 kilopascals to about +50 kilopascals above ambient pressure (11). Alternatively, a negative ear canal pressure (10) relative to ambient pressure (11) can be achieved by maintaining the constant pressure amplitude (77) within a range from about -50 kilopascals to about 0 kilopascals below ambient pressure (11).

[0093] 14B-14G and 15B-15G, the fluid flow generator (2) can be configured for repeated operation to generate a fluid flow (8) having pressure waves (78) including a pressure wave amplitude (77) and a pressure wave frequency (79). For certain embodiments, the fluid flow generator (2), including the volume-adjustable element (13), can be operated from an undeformed state (21) toward a deformed state (20) over a time period (76) to generate a fluid flow (8) exiting the axial earphone bore (4) toward the ear canal (6), whereby the fluid flow (8) has pressure waves (78) including a pressure wave amplitude (77) and a pressure wave frequency (79) that result in a positive ear canal pressure (10) relative to ambient pressure (11) (as shown in the example of FIGS. 14B-14G). For other specific embodiments, a fluid flow generator (2) comprising a volume-adjustable element (13) can be operated from a deformed state (20) toward an undeformed state (21) to generate a fluid flow (8) from the ear canal (6) toward the fluid flow generator (2) and into the axial earphone bore (4) over a time period (76), whereby the fluid flow (8) has pressure waves (78) comprising a pressure wave amplitude (77) and a pressure wave frequency (79) that result in a negative ear canal pressure (10) relative to ambient pressure (11) (as shown in the example of Figures 15B through 15G).

[0094] Referring again primarily to Figures 14A through 15G, the fluid flow generator (2) can be configured for repetitive operation to generate a fluid flow (8) having pressure waves (78) including a pressure wave amplitude (77) as described above and a pressure wave frequency (79) that is typically in the range of 0 Hz to about 10 Hz; however, embodiments can have fewer or more pressure wave frequencies (79) depending on the application. For certain embodiments, the one or more pressure wave frequencies (79) can be between 0 Hz and about 1 Hz, between about 0.5 Hz and about 1.5 Hz, between about 1 Hz and about 2 Hz, between about 1.5 Hz and about 2.5 Hz, between about 2 Hz and about 3 Hz, between about 2.5 Hz and about 3.5 Hz, between about 3 Hz and about 4 Hz, between about 3.5 Hz and about 4.5 Hz, between about 4 Hz and about 5 Hz, between about 5 Hz and about 6 Hz, between about 6 Hz and about 7 Hz, between about 7 Hz and about 8 Hz, between about 8 Hz and about 9 Hz, between about 9 Hz and about 10 Hz, between about 10 Hz and about 12 Hz, between about 12 Hz and about 14 Hz, between about 14 Hz and about 15 Hz, between about 15 Hz and about 16 Hz, between about 16 Hz and about 18 Hz, between about 18 Hz and about 20 Hz, between about 18 Hz and about 22 Hz, between about 18 Hz and about 24 Hz, between about 18 Hz and about 26 Hz, between about 18 Hz and about 28 Hz, between about 18 Hz and about 28 Hz, between about 18 Hz and about 29 Hz, between about 29 Hz and about about 5.5 Hz to about 6 Hz, about 5 Hz to about 6 Hz, about 5.5 Hz to about 6.5 Hz, about 6 Hz to about 7 Hz, about 6.5 Hz to about 7.5 Hz, about 7 Hz to about 8 Hz, about 7.5 Hz to about 8.5 Hz, about 8 Hz to about 9 Hz, about 8.5 Hz to about 9.5 Hz, and about 9 Hz to about 10 Hz.

[0095] Depending on the method of use, one or more pressure wave frequencies (79) can be generated using the ear canal pressure regulating device (1), which may be further influenced by factors such as the anatomy, physiology, or biochemistry of the user (23) of the ear canal (24); the target disorder symptoms to be alleviated; the target disorder to be treated; the observable effects of using one or more pressure wave frequencies (79) in the particular method of use of the ear canal pressure regulating device (1); or the like; or a combination thereof, but not to the extent that it causes discomfort to the user (23) or damage to the ear canal (24) or eardrum (25).

[0096] The pressure waves (78) can oscillate at a desired pressure wave frequency (79) only within a positive pressure amplitude (77) within a range of 0 kilopascals to approximately +50 kilopascals above ambient pressure (11), which can correspondingly generate a positive ear canal pressure (10) relative to ambient pressure (11), for example, by increasing ear canal pressure (10) relative to ambient pressure (11) to alleviate disorder symptoms or treat the disorder (as shown in the examples of Figures 14B through 14G). For yet other specific embodiments, the pressure waves (78) may oscillate at a desired pressure wave frequency (79) only within a negative pressure amplitude (77) within a range of approximately -50 kilopascals to 0 kilopascals below ambient pressure (11), which may correspondingly generate a negative ear canal pressure (10) relative to ambient pressure (11), e.g., by reducing ear canal pressure (10) relative to ambient pressure (11) to alleviate disorder symptoms or treat the disorder (as shown in the examples of Figures 15B through 15G).

[0097] Referring again primarily to Figures 14B through 15G, the pressure wave (78) can have many and varied waveforms, depending on the application, corresponding to the many and varied disorder symptoms that may be alleviated or disorders that may be treated by operation of the ear canal pressure regulating device (1). As illustrative examples, the pressure wave (78) can be a sinusoidal wave with a smooth, repeating periodic oscillation (as shown in the examples of Figures 14B and 15B), a square wave, rectangular wave, in which the pressure amplitude (77) alternates at a steady frequency between fixed minimum and maximum values, a trapezoidal or frustoconical wave, in which the crest of the pressure wave (78) has a constant pressure amplitude (77) over the time period (76) (as shown in the examples of Figures 14C, 15C, 14F, and 15F), a triangular wave with linear leading and trailing edges (as shown in the examples of Figures 14D and 15D). The waveform may be a sawtooth waveform (as shown in the example of FIG. 14E ), where the leading edge varies the pressure amplitude (77) for a period of time (76) that is greater than the period of time (76) that the trailing edge varies the pressure amplitude (77), an inverted sawtooth waveform (as shown in the example of FIG. 15E ), where the leading edge varies the pressure amplitude (77) for a period of time (76) that is less than the period of time (76) that the trailing edge varies the pressure amplitude (77), or a combination thereof (as shown in the examples of FIGS. 14G and 15G ).

[0098] For certain embodiments, the fluid flow generator (2) and a 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).

[0099] Reference is now made primarily to FIGS. 14A through 14G, which illustrate the pressure difference (9) between ear canal pressure (10) and ambient pressure (11) achieved over a time period (76) by operation of an embodiment of an ear canal pressure regulating device (1) to generate a positive ear canal pressure (10) relative to ambient pressure (11) (as shown in the examples of FIGS. 2A, 5, and 11A through 11D). Particular embodiments of ear canal pressure regulating devices (1) include a third valve (58) that remains substantially leak-proof to fluid flow (8) within the third fluid flow conduit (57) up to approximately a 50 kilopascal pressure difference amplitude (59) between the ear canal pressure (10) and ambient pressure (11) (represented in each graph as having a pressure amplitude (77) of zero). However, this need not limit embodiments to only those capable of generating a positive ear canal pressure (10) relative to a preselected ambient pressure (11) of up to +50 kilopascals. Other embodiments may operate to generate a positive ear canal pressure (10) relative to ambient pressure (11), which may be any amount above ambient pressure (11), but not so much as to cause discomfort to the user (23) or injury to the ear canal (24) or eardrum (25).

[0100] Referring now primarily to FIG. 14A , for certain embodiments, the fluid flow generator (2) can be operated to generate an ear canal pressure (10) having a maximum pressure amplitude (77) of up to about +50 kilopascals above ambient pressure (11). The ear canal pressure (10) can be maintained at about +50 kilopascals above ambient pressure (11) for a time period (76). After the time period (76) has elapsed, the third valve pressure relief element (72) can be operated to return the ear canal pressure (10) to ambient pressure (11). The operation can be, but is not necessarily, repeated.

[0101] Referring now primarily to Figure 14B, for certain embodiments, the fluid flow generator (2) can be operated to generate an ear canal pressure (10) having a maximum pressure amplitude (77) of up to about +50 kilopascals above ambient pressure (11). The third valve pressure relief element (72) can be operated to return the ear canal pressure (10) to ambient pressure (11), thereby causing the pressure wave (78) to be a sine wave with smooth, repeating periodic oscillations. The operation can be repeated to administer pulsed changes in the ear canal pressure (10).

[0102] Referring now primarily to Figure 14D, for certain embodiments, the fluid flow generator (2) can be operated to generate an ear canal pressure (10) having a maximum pressure amplitude (77) of up to about +50 kilopascals above ambient pressure (11). The third valve pressure relief element (72) can be operated to return the ear canal pressure (10) to ambient pressure (11), whereby the pressure wave (78) can be a triangular wave with linear leading and trailing edges. The operation can be repeated to administer a pulse-like change in ear canal pressure (10).

[0103] Referring now primarily to FIG. 14E , for certain embodiments, the fluid flow generator (2) can be operated to generate an ear canal pressure (10) having a maximum pressure amplitude (77) of up to about +50 kilopascals above ambient pressure (11). The third valve pressure relief element (72) can be operated to return the ear canal pressure (10) to ambient pressure (11), whereby the pressure wave (78) can be a sawtooth wave, with a leading edge varying the pressure amplitude (77) over a time period (76) that exceeds a time period (76) in which the trailing edge varies the pressure amplitude (77). The operation can be repeated to administer a pulse-like change in ear canal pressure (10).

[0104] 14C and 14F, for certain embodiments, the fluid flow generator (2) can be operated to generate an ear canal pressure (10) having a maximum pressure amplitude (77) of up to about +50 kilopascals above ambient pressure (11). The ear canal pressure (10) can be maintained at about +50 kilopascals above ambient pressure (11) for a time period (76). After the time period (76) has elapsed, the third valve pressure relief element (72) can be operated to return the ear canal pressure (10) to ambient pressure (11). The operation can be repeated to administer a pulsed change in the ear canal pressure (10).

[0105] Referring now primarily to FIG. 14G, for certain embodiments, the fluid flow generator (2) can be operated to increase the ear canal pressure (10) in a series of incremental pressure increments having a maximum pressure amplitude (77) of approximately +50 kilopascals above ambient pressure (11). Each of the series of incremental pressure increments can increase the ear canal pressure (10) by approximately 10 kilopascals to approximately 15 kilopascals above ambient pressure (11), with each incremental pressure increase in the ear canal pressure (10) being maintained for a time period (76). After achieving the maximum pressure amplitude (77) of approximately +50 kilopascals above ambient pressure (11) and the time period (76) has elapsed, the third valve pressure relief element (72) can be operated to return the ear canal pressure (10) to ambient pressure (11). The operation can be repeated to administer a pulsed change in the ear canal pressure (10).

[0106] Reference is now made primarily to FIGS. 15A through 15G, which illustrate the pressure difference (9) between ear canal pressure (10) and ambient pressure (11) achieved over a time period (76) by operation of an embodiment of an ear canal pressure regulating device (1) to generate a negative ear canal pressure (10) relative to ambient pressure (9) (as shown in the examples of FIGS. 2B, 6, and 12A through 12D). Particular embodiments of ear canal pressure regulating devices (1) include a third valve (58) that remains substantially leak-proof to fluid flow (8) within the third fluid flow conduit (57) up to a pressure difference amplitude (59) of approximately 50 kilopascals between the ear canal pressure (10) and ambient pressure (11) (represented in each graph as having a pressure amplitude (77) of zero). However, this need not limit embodiments to only those capable of generating a negative ear canal pressure (10) relative to a preselected ambient pressure (77) of up to -50 kilopascals. Other embodiments may operate to generate a negative ear canal pressure (10) relative to ambient pressure (11), which may be any amount below ambient pressure (11), but not so much as to cause discomfort to the user (23) or injury to the ear canal (24) or eardrum (25).

[0107] Referring now primarily to FIG. 15A , for certain embodiments, the fluid flow generator (2) can be operated to generate an ear canal pressure (10) having a maximum pressure amplitude (77) of up to approximately −50 kilopascals below ambient pressure (11). The ear canal pressure (10) can be maintained at approximately −50 kilopascals below ambient pressure (11) for a time period (76). After the time period (76) has elapsed, the third valve pressure relief element (72) can be operated to return the ear canal pressure (10) to ambient pressure (11). The operation can be, but is not necessarily, repeated.

[0108] Referring now primarily to Figure 15B, for certain embodiments, the fluid flow generator (2) can be operated to generate an ear canal pressure (10) having a maximum pressure amplitude (77) of up to approximately -50 kilopascals below ambient pressure (11). The third valve pressure relief element (72) can be operated to return the ear canal pressure (10) to ambient pressure (11), whereby the pressure wave (78) can be a sinusoidal wave with smooth, repeating periodic oscillations. The operation can be repeated to administer pulsed changes in the ear canal pressure (10).

[0109] 15D, for certain embodiments, the fluid flow generator (2) can be operated to generate an ear canal pressure (10) having a maximum pressure amplitude (77) of up to about -50 kilopascals below ambient pressure (11). The third valve pressure relief element (72) can be operated to return the ear canal pressure (10) to ambient pressure (11), whereby the pressure wave (78) can be a triangular wave with linear leading and trailing edges. The operation can be repeated to administer a pulse-like change in ear canal pressure (10).

[0110] Referring now primarily to FIG. 15E , for certain embodiments, the fluid flow generator (2) can be operated to generate an ear canal pressure (10) having a maximum pressure amplitude (77) of up to approximately −50 kilopascals below ambient pressure (11). The third valve pressure relief element (72) can be operated to return the ear canal pressure (10) to ambient pressure (11), whereby the pressure wave (78) can be an inverted sawtooth wave, with a leading edge varying the pressure amplitude (77) for a time period (76) that is less than the time period (76) in which the trailing edge varies the pressure amplitude (77). The operation can be repeated to administer a pulsed change in the ear canal pressure (10).

[0111] 15C and 15F, for certain embodiments, the fluid flow generator (2) can be operated to generate an ear canal pressure (10) having a maximum pressure amplitude (77) of up to approximately -50 kilopascals below ambient pressure (11). The ear canal pressure (10) can be maintained at approximately -50 kilopascals below ambient pressure (11) for a time period (76). After the time period (76) has elapsed, the third valve pressure relief element (72) can be operated to return the ear canal pressure (10) to ambient pressure (11). The operation can be repeated to administer a pulsed change in the ear canal pressure (10).

[0112] Referring now primarily to FIG. 15G, for certain embodiments, the fluid flow generator (2) can be operated to reduce the ear canal pressure (10) in a series of incremental pressure reductions having a maximum pressure amplitude (77) of approximately -50 kilopascals below ambient pressure (11). Each of the series of incremental pressure reductions can reduce the ear canal pressure (10) from approximately -10 kilopascals to approximately -15 kilopascals below ambient pressure (11), with each incremental pressure reduction in the ear canal pressure (10) being maintained for a time period (76). After achieving the maximum pressure amplitude (77) of approximately -50 kilopascals below ambient pressure (11) and the time period (76) has elapsed, the third valve pressure relief element (72) can be operated to return the ear canal pressure (10) to ambient pressure (11). The operation can be repeated to administer a pulsed change in the ear canal pressure (10).

[0113] For certain embodiments, the ear canal pressure regulating device (1) may further include a housing (80) having an interior housing surface defining a generally hollow interior space in which components of the ear canal pressure regulating device (1) may be stored. For certain embodiments, the housing (80) may be configured to fill the turbinate area (82) of the ear (35), whether in whole or in part, without extending any substantial distance outside the ear canal (24), thereby providing a discrete, unobtrusive, portable configuration that may be used upon occurrence to alleviate one or more disorder symptoms, e.g., nerve-mediated pain, or to treat one or more disorders, e.g., craniofacial pain syndromes or headache syndromes.

[0114] The fluid flow generator (2) of the ear canal pressure regulating device (1) described above typically delivers a fluid flow (8) of air to the ear canal (6) to achieve a pressure differential (9) between the ear canal pressure (10) and ambient pressure (11), but this is not intended to be limiting with respect to the various fluids that may be delivered to the ear canal (6) by the ear canal pressure regulating device (1). As illustrative examples, the various fluids may include purified gases such as oxygen, nitrogen, argon, or the like; partial pressure mixtures of gases; liquids such as water, oil, alcohol, or the like; or combinations thereof.

[0115] Additionally, although the transfer of fluid flow (8) or fluid volume (12) between components of the ear canal pressure regulating device (1), between components of the ear canal pressure regulating device (1) and the ear canal (6), or between components of the ear canal pressure regulating device (1) and ambient pressure (11) may typically be described above as between a first point and a second point for purposes of brevity, the transfer of fluid flow (8) or fluid volume (12) includes any point 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 ear canal (6) can travel along a fluid flow path (62) that includes the fluid flow generator (2), a first end (50) of the first fluid flow conduit, a first portion (53) of the first fluid flow conduit (49), a first valve (52), a second portion (54) of the first fluid flow conduit (49), a second end (51) of the first fluid flow conduit, a first end (31) of the earbud, the axial earbud bore (4), a second end (29) of the earbud, and the ear canal (6).

[0116] A method of producing a particular embodiment of an ear canal pressure regulating device (1) includes the steps of: providing a fluid flow generator (2) capable of generating a fluid flow (8); providing a valved conduit (5) fluidly connectable to the fluid flow generator (2), the valved conduit (5) having a first fluid flow conduit (49); providing a first valve (52) capable of blocking the first fluid flow conduit (49) and unidirectionally adjusting the fluid flow (8) within the first fluid flow conduit (49); and providing an earphone. and providing an axial earphone bore (4) in communication between a first end (31) of the earphone (3) and a second end (32) of the earphone, the axial earphone bore (4) being fluidly connectable to a valved conduit (5) facing the fluid flow generator (2), the earphone (3) having a flexible earphone exterior surface (7) configured to sealably engage the ear canal (6) as a barrier between ear canal pressure (10) and ambient pressure (11).

[0117] The method of producing certain embodiments of the ear canal pressure regulating device (1) may further include providing a fluid flow generator (2) configured to generate a fluid flow (8) having a fluid volume (12) within a range of 0 milliliters to about 20 milliliters. For certain embodiments, the fluid volume (12) may range from 0 milliliters to about 2 milliliters, from about 1 milliliter to about 3 milliliters, from about 2 milliliters to about 4 milliliters, from about 3 milliliters to about 5 milliliters, from about 4 milliliters to about 6 milliliters, from about 5 milliliters to about 7 milliliters, from about 6 milliliters to about 8 milliliters, from about 7 milliliters to about 9 milliliters, from about 8 milliliters to about 10 milliliters, from about 9 milliliters to about 11 milliliters, from about 10 milliliters to about 12 milliliters, or from about 11 milliliters to about 15 milliliters. The fluid volume (12) may have a preselected fluid volume (12) that may be selected from one or more of the group including or consisting of: milliliters to about 13 milliliters, about 12 milliliters to about 14 milliliters, about 13 milliliters to about 15 milliliters, about 14 milliliters to about 16 milliliters, about 15 milliliters to about 17 milliliters, about 16 milliliters to about 18 milliliters, about 17 milliliters to about 19 milliliters, and about 18 milliliters to about 20 milliliters.

[0118] A method of producing certain embodiments of the ear canal pressure regulating device (1) can further include providing a valved conduit (5) having a configuration that is removably coupleable to the fluid flow generator (2) and the earphone (3). For certain embodiments, the method can further include providing a valved conduit (5) that, in a first configuration (45), couples with the fluid flow generator (2) and the earphone (3) and has a configuration that is unidirectionally adjustable in a first direction (47) within the first fluid flow conduit (49). For other certain embodiments, the method can further include providing a valved conduit (5) that, in a second configuration (46), couples with the fluid flow generator (2) and the earphone (3) and has a configuration that is unidirectionally adjustable in a second direction (48) within the first fluid flow conduit (49).

[0119] A method of producing certain embodiments of the ear canal pressure regulating device (1) may further include the step of providing a first valve (52) having a configuration capable of dividing the first fluid flow conduit (49) into a first portion (53) proximate a first end (50) of the first fluid flow conduit and a second portion (54) proximate a second end (51) of the first fluid flow conduit, and may further include the step of providing a second fluid flow conduit (55) having a configuration capable of fluidly coupling between the first portion (53) of the first fluid flow conduit (49) and ambient pressure (11), and may further include the step of providing a second valve (56) having a configuration capable of blocking the second fluid flow conduit (55) and adjusting fluid flow (8) in one direction within the second fluid flow conduit (55).

[0120] A method of producing a particular embodiment of the ear canal pressure regulating device (1) may further include providing a fluid flow generator (2) configured as a volume-adjustable element (13) having an internal volume (19), the volume-adjustable element (13) having a deformed state (20) that reduces the internal volume (19) and generates a fluid flow (8) in the first fluid flow conduit (49), and a first valve (52) that unidirectionally regulates the fluid flow (8) so that it flows out of the axial earphone bore (4) of the earphone (3). For certain embodiments, the volume-adjustable element (13) can return to its undeformed state (21), increasing its internal volume (19) and generating fluid flow (8) within the second fluid flow conduit (55), the second valve (56) regulates fluid flow (8) in one direction, from ambient pressure (11) toward the volume-adjustable element (13), and the first valve (52) blocks fluid flow (8) from the second portion (54) toward the first portion (53) within the first fluid flow conduit (49).

[0121] A method of producing a particular embodiment of the ear canal pressure regulating device (1) may further include providing a fluid flow generator (2) configured as a volume-adjustable element (13) having an internal volume (19), the volume-adjustable element (13) having a deformed state (20) that reduces the internal volume (19) and generates a fluid flow (8) in the second fluid flow conduit (55), and the second valve (52) unidirectionally adjusts the fluid flow (8) so that it flows out of the second fluid flow conduit (55) toward ambient pressure (11). For certain embodiments, the volume-adjustable element (13) can return to its undeformed state (21), increasing its internal volume (19) and generating fluid flow (8) within the first fluid-flow conduit (49), the first valve (52) unidirectionally regulates fluid flow (8) from the axial earphone bore (4) of the earphone (3) toward the volume-adjustable element (13), and the second valve (56) blocks fluid flow (8) within the second fluid-flow conduit (55) from ambient pressure (11) toward the first portion (53).

[0122] A method for producing certain embodiments of the ear canal pressure regulating device (1) may further include providing a third fluid flow conduit (57) having a configuration capable of fluidly coupling between the second portion (54) of the first fluid flow conduit (49) and ambient pressure (11), and may further include providing a third valve (58) having a configuration capable of blocking the third fluid flow conduit (57) and adjusting the fluid flow (8) in one direction within the third fluid flow conduit (57). For certain embodiments, the method may further include providing a third valve (58) having a configuration capable of adjusting the fluid flow (8) to flow out to ambient pressure (11). For other certain embodiments, the method for producing certain embodiments of the ear canal pressure regulating device (1) may further include providing a third valve (58) having a configuration capable of adjusting the fluid flow (8) to flow in from ambient pressure (11).

[0123] A method of producing certain embodiments of the ear canal pressure regulating device (1) may further include providing a third valve (58) having a configuration capable of blocking fluid flow (8) between the second portion (54) of the first fluid flow conduit (49) and ambient pressure (11) until the pressure differential (9) between the second portion (54) of the first fluid conduit (49) and ambient pressure (11) exceeds a preselected pressure differential (9) having a pressure differential amplitude (59) of between 0 kilopascals and about 50 kilopascals. For certain embodiments, the one or more preselected pressure differential amplitudes (59) may be between 0 kilopascals and about 5 kilopascals, between about 2.5 kilopascals and about 7.5 kilopascals, between about 5 kilopascals and about 10 kilopascals, between about 7.5 kilopascals and about 12.5 kilopascals, between about 10 kilopascals and about 15 kilopascals, between about 12.5 kilopascals and about 17.5 kilopascals, between about 15 kilopascals and about 20 kilopascals, between about 17.5 kilopascals and about 22.5 kilopascals, between about 20 kilopascals and about 25 kilopascals, between about 22.5 kilopascals and about 25 kilopascals, or between about 25 kilopascals and about 25 kilopascals. The pressure may be selected from the group including or consisting of: about 27.5 kilopascals to about 27.5 kilopascals, about 25 kilopascals to about 30 kilopascals, about 27.5 kilopascals to about 32.5 kilopascals, about 30 kilopascals to about 35 kilopascals, about 32.5 kilopascals to about 37.5 kilopascals, about 35 kilopascals to about 40 kilopascals, about 37.5 kilopascals to about 42.5 kilopascals, about 40 kilopascals to about 45 kilopascals, about 42.5 kilopascals to about 47.5 kilopascals, and about 45 kilopascals to about 50 kilopascals.

[0124] A method of producing certain embodiments of the ear canal pressure regulating device (1) may further include providing a second valve pressure relief element (71) having a configuration capable of being coupled to the second valve (56) and a third valve pressure relief element (72) having a configuration capable of being coupled to the third valve (58), each manually operable to generate a fluid flow (8) in the second or third fluid flow conduit (55)(57), respectively.

[0125] A method of producing certain embodiments of the ear canal pressure regulating device (1) can further include providing a valved conduit (5) coupled to the fluid flow generator (2) and the earbud (3) in a first configuration (45) and having a configuration for unidirectionally adjusting fluid flow (8) in a first direction (47) within a first fluid flow conduit (49) to exit an axial earbud bore (4) of the earbud (3). For certain embodiments, the method can further include providing the fluid flow generator (2) configured as a volume-adjustable element (13) operable from an undeformed state (21) toward a deformed state (20) to generate a fluid flow (2) exiting the axial earbud bore (4) over a time period (76).

[0126] A method of producing certain embodiments of an ear canal pressure regulating device (1) can further include providing a fluid flow generator (2) configured to generate a fluid flow (8) that is repeatedly operable from an undeformed state (21) toward a deformed state (20) and has a pressure wave (78) comprising a pressure wave amplitude (77) and a pressure wave frequency (79). For certain embodiments, the pressure wave frequency (79) can be in the range of 0 Hz to about 10 Hz. For certain embodiments, the one or more pressure wave frequencies (79) can be in the range of 0 Hz to about 1 Hz, about 0.5 Hz to about 1.5 Hz, about 1 Hz to about 2 Hz, about 1.5 Hz to about 2.5 Hz, about 2 Hz to about 3 Hz, about 2.5 Hz to about 3.5 Hz, about 3 Hz to about 4 Hz, about 3.5 Hz to about 4.5 Hz, about 4 Hz to about 5 Hz, about 4.5 Hz, or about 5 Hz. about 5.5 Hz to about 6 Hz, about 5 Hz to about 6 Hz, about 5.5 Hz to about 6.5 Hz, about 6 Hz to about 7 Hz, about 6.5 Hz to about 7.5 Hz, about 7 Hz to about 8 Hz, about 7.5 Hz to about 8.5 Hz, about 8 Hz to about 9 Hz, about 8.5 Hz to about 9.5 Hz, and about 9 Hz to about 10 Hz.

[0127] A method of producing a particular embodiment of the ear 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 repeatedly operable in an alternating manner to generate a fluid flow (2) having a pressure wave (78) comprising a pressure wave amplitude (77) and a pressure wave frequency (79).

[0128] A method of producing certain embodiments of the ear canal pressure regulating device (1) can further include providing a valved conduit (5) coupled to the fluid flow generator (2) and the earbud (3) in the second configuration (46) and having a configuration for unidirectionally adjusting fluid flow (8) in a second direction (48) within the first fluid flow conduit (49) for flow into the axial earbud bore (4) of the earbud (3). For certain embodiments, the method can further include providing the fluid flow generator (2) configured as a volume-adjustable element (13) operable from a deformed state (20) toward an undeformed state (21) to generate a fluid flow (2) from the axial earbud bore (4) over a time period (76).

[0129] A method of producing certain embodiments of an ear canal pressure regulating device (1) can further include providing a fluid flow generator (2) configured to generate a fluid flow (8) that is repeatedly operable from a deformed state (20) toward an undeformed state (21) and has a configuration for generating a fluid flow (8) having pressure waves (78) comprising a pressure wave amplitude (77) and a pressure wave frequency (79). For certain embodiments, the pressure wave frequency (79) can be in the range of 0 Hz to about 10 Hz. For certain embodiments, the one or more pressure wave frequencies (79) can be in the range of 0 Hz to about 1 Hz, about 0.5 Hz to about 1.5 Hz, about 1 Hz to about 2 Hz, about 1.5 Hz to about 2.5 Hz, about 2 Hz to about 3 Hz, about 2.5 Hz to about 3.5 Hz, about 3 Hz to about 4 Hz, about 3.5 Hz to about 4.5 Hz, about 4 Hz to about 5 Hz, about 4.5 Hz, or about 5 Hz. about 5.5 Hz to about 6 Hz, about 5 Hz to about 6 Hz, about 5.5 Hz to about 6.5 Hz, about 6 Hz to about 7 Hz, about 6.5 Hz to about 7.5 Hz, about 7 Hz to about 8 Hz, about 7.5 Hz to about 8.5 Hz, about 8 Hz to about 9 Hz, about 8.5 Hz to about 9.5 Hz, and about 9 Hz to about 10 Hz.

[0130] A method of producing a particular embodiment of the ear 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 alternately and repeatedly operable to generate a fluid flow (2) having a pressure wave (78) comprising a pressure wave amplitude (77) and a pressure wave frequency (79).

[0131] For certain embodiments, the components of the ear canal pressure adjusting device (1) can be formed entirely from the same material, or alternatively, various components of the ear canal pressure adjusting device (1) can be formed from different materials. Additionally, for certain embodiments, the ear canal pressure adjusting device (1) or components of the ear canal pressure adjusting device (1) can be produced from any of a variety of processes, depending on the application, such as press molding, injection molding, machining, printing, three-dimensional printing, or the like, or a combination thereof, either as a single unit, assembled from multiple parts into an embodiment of the ear canal pressure adjusting device (1), or provided as multiple parts for assembly of an embodiment of the ear canal pressure adjusting device (1).

[0132] The components of the ear canal pressure regulating device (1) can be produced from any of a variety of materials that can provide an embodiment of the ear 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 various elastomeric compounds, plastics, plastic-like materials, acrylics, polyamides, polyesters, polypropylenes, polyvinyl chloride-based materials, silicone-based materials, or the like, or combinations thereof.

[0133] A method of using a particular embodiment of an ear canal pressure regulating device (1) includes the steps of obtaining an ear canal pressure regulating device (1), the device comprising: 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 is blockable by a first valve (52) to regulate fluid flow (8) in one direction within the first fluid flow conduit (49); and an earphone (3) having an axial earphone bore (4) in communication between a first end (31) of the earphone and a second end (29) of the earphone, the axial earphone The method may include the steps of: an earphone (3), the bore (4) being fluidly coupled to a valved conduit (5) facing a fluid flow generator (2), the earphone (3) having a flexible earphone exterior surface (7) configured to sealably engage the ear canal (6) as a barrier between ear canal pressure (10) and ambient pressure (11); sealably engaging the earphone exterior surface (7) of the earphone (3) with the ear canal (6); generating a fluid flow (8) between the fluid flow generator (2) and the axial earphone bore (4); and regulating a pressure differential (9) between the ear canal pressure (10) and ambient pressure (11).

[0134] For certain embodiments, a method of using an ear canal pressure regulating device (1) includes the steps of obtaining an ear canal pressure regulating device (1), the device comprising: a fluid flow generator (2) that generates a fluid flow (8); a valved conduit (5) having a first fluid flow conduit (49) that is blockable by a first valve (52) to regulate the fluid flow (8) in one direction within the first fluid flow conduit (49); an earphone (3) having an axial earphone bore (4) in communication between a first end (31) of the earphone and a second end (29) of the earphone, the earphone (3) having a flexible earphone outer surface (7) configured to sealably engage the ear canal (6) as a barrier between ear canal pressure (10) and ambient pressure (11); and in a first configuration (45), fluidly coupling the valved conduit (5) with the fluid flow generator (2) and the axial earphone bore (4) of the earphone (3) and unidirectionally regulating a fluid flow (8) in a first direction (47) within the first fluid flow conduit (49); sealingly engaging an earphone exterior surface (7) of the earphone (3) with the ear canal (6); generating a fluid flow (8) within the first fluid flow conduit (49) between the fluid flow generator (2) and the axial earphone bore (4) in the first direction (47); and regulating a pressure difference (9) between an ear canal pressure (10) and ambient pressure (11), wherein the ear canal pressure (10) exceeds the ambient pressure (11).

[0135] For certain embodiments, the method of using the ear canal pressure regulating device (1) may further include the step of operating the pressure relief element (70) to generate a fluid flow (8) from the ear canal (6) toward ambient pressure (11) and returning the ear canal pressure (10) to ambient pressure (11). For certain embodiments, the method may further include the step of disengaging the earphone exterior surface (7) of the earphone (3) from the ear canal (6).

[0136] For certain embodiments, the method of using the ear canal pressure regulating device (1) may further include decoupling the valved conduit (5) in the first configuration (45) from the fluid flow generator (2) and the axial earphone bore (4) of the earphone (3).

[0137] For certain embodiments, the method of using the ear canal pressure regulating device (1) may further include, in the second configuration (46), fluidly coupling the valved conduit (5) with the fluid flow generator (2) and the axial earphone bore (4) of the earphone (3) and unidirectionally regulating the fluid flow (8) in a second direction (48) within the first fluid flow conduit (49); sealingly engaging the earphone exterior surface (7) of the earphone (3) with the ear canal (7); generating the fluid flow (8) between the fluid flow generator (2) and the axial earphone bore (4) in the second direction (48) within the first fluid flow conduit (49); and regulating a pressure difference (9) between the ear canal pressure (10) and ambient pressure (11), wherein the ear canal pressure (10) is less than the ambient pressure (11).

[0138] For certain embodiments, the method of using the ear canal pressure regulating device (1) may further include the step of operating the pressure relief element (70) to generate a fluid flow (8) from ambient pressure (11) toward the ear canal (6) and returning the ear canal pressure (10) to ambient pressure (11). For certain embodiments, the method may further include the step of disengaging the earphone exterior surface (7) of the earphone (3) from the ear canal (6).

[0139] For certain embodiments, the method of using the ear canal pressure regulating device (1) may further include decoupling the valved conduit (5) in the second configuration (46) from the fluid flow generator (2) and the axial earphone bore (4) of the earphone (3).

[0140] As can be readily appreciated from the foregoing, the basic concepts of the present invention may be embodied in a variety of ways, and the present invention encompasses numerous and varied embodiments of ear canal pressure regulating devices and methods for making and using such ear canal pressure regulating devices, including the best mode thereof.

[0141] Thus, the particular embodiments or elements of the invention disclosed by the description or shown in the figures or tables accompanying this application are not intended to be limiting, but rather are generally intended as examples of the many and various embodiments encompassed by the invention, or equivalents encompassed for any particular element thereof. Additionally, specific descriptions of a single embodiment or element of the invention may not explicitly describe all possible embodiments or elements. Many alternatives are implicitly disclosed by the description and figures.

[0142] It should be understood that each element of an apparatus or each step of a method may be described by apparatus or method terminology. Such terms may be substituted, if desired, to clarify the implicitly broad coverage to which the present invention is entitled. By way of example only, it should be understood that all steps of a method may be disclosed as an action, a means for performing that action, or an element that causes that action. Similarly, each element of an apparatus may be disclosed as a physical element or an action that the physical element facilitates. By way of example only, a disclosure of "fluid flow" should be understood to encompass a disclosure of the action of "causing fluid flow," whether or not explicitly discussed. Conversely, if there is a de facto disclosure of "causing fluid flow," such disclosure should be understood to encompass a disclosure of "fluid flow" and also a "means for causing fluid flow." Such alternative terms for each element or step should be understood to be expressly included in the description.

[0143] Additionally, it should be understood that for each term used, unless its usage in this application is inconsistent with such interpretation, the common dictionary definition should be understood to be included in the description of each term as contained in the Random House Webster's Unabridged Dictionary, second edition, each definition of which is incorporated herein by reference.

[0144] All numerical values ​​herein are assumed to be modified by the term "about," whether or not explicitly stated. For purposes of the present invention, ranges may be expressed as from "about" one particular value to "about" another particular value. When such a range is expressed, another embodiment includes from the one particular value to the other particular value. The recitation of numerical ranges by endpoints includes all values ​​subsumed within that range. A numerical range from 1 to 5, for example, includes the values ​​1, 1.5, 2, 2.75, 3, 3.80, 4, 5, etc. It is further understood that each of the endpoints of a range is significant both in relation to the other endpoint, and independently of the other endpoint. When values ​​are expressed as approximations, by use of the antecedent "about," it will be understood that the particular value forms another embodiment. The term "about" generally refers to a range of numerical values ​​that one of skill in the art would consider equivalent to the recited values ​​or to have the same function or result. Similarly, the antecedent "substantially" means roughly, but not entirely, in the same form, manner, or degree; particular elements will have a range of configurations that one of ordinary skill in the art would consider to have the same function or result. When particular elements are expressed as approximations using the antecedent "substantially," it will be understood that the particular elements form another embodiment.

[0145] Furthermore, for purposes of the present invention, the term "a" or "an" entity refers to one or more of that entity, unless otherwise limited. Thus, the terms "a" or "an," "one or more," and "at least one" can be used interchangeably herein.

[0146] Accordingly, it should be understood that the applicant claims at least: i) the ear canal pressure regulating devices as disclosed and described herein; ii) the related methods as disclosed and described; iii) similarities, equivalents, and even implicit variations of each of these devices and methods; iv) alternative embodiments thereof that achieve each of the functions shown, disclosed, or described; v) alternative designs and methods thereof that achieve each of the indicated functions that are implicit in achieving those disclosed and described; vi) each feature, component, and step shown as a separate and independent invention; vii) uses that are enhanced by the various systems or components disclosed; viiii) resulting products produced by such systems or components; ix) methods and apparatus substantially as hereinbefore described and in connection with any of the accompanying examples; and x) the various combinations and permutations of each of the foregoing elements disclosed.

[0147] The Background section of this patent application describes the field of business to which the present invention pertains. This section may also incorporate or include certain U.S. patents, patent applications, publications, or paraphrases of the subject matter of the present invention that are useful in relating information, problems, or concerns about the state of the art to which the present invention is directed. It is not intended that any U.S. patent, patent application, publication, statement, or other information cited or incorporated herein be read, construed, or deemed to be an admission that it is prior art with respect to the present invention.

[0148] The claims set forth herein are hereby incorporated by reference, where applicable, as part of this description of the invention, and Applicant expressly reserves the right to use all or a portion of such incorporated content of such claims as additional description in support of the claims or any part or all of any element or component thereof, and Applicant further expressly reserves the right, as appropriate, to move any part or all of the incorporated content of such claims or any element or component thereof from the description to the claims or vice versa, and to define the matter for which protection is sought by this application or by any subsequent application or continuation, divisional, or continuation-in-part application thereof, or to obtain any benefit of, or comply with, any national or treaty patent laws, rules, or regulations, and such content incorporated by reference shall survive throughout the pendency of this application, including any subsequent continuation, divisional, or continuation-in-part application thereof, or any reissue or extension thereof.

[0149] Additionally, the claims set forth herein, if applicable, are further intended to describe the metes and bounds of a limited number of preferred embodiments of the present invention and should not be construed as the broadest embodiment of the present invention or as an exhaustive list of embodiments of the present invention that may be claimed. Applicant does not waive any right to develop any claims as part of any continuation, division, or continuation-in-part or similar application based on the description set forth above.

Claims

[Claim 1] The invention described in this specification.

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