EXTERNAL EAR CANAL PRESSURE REGULATION DEVICE
An external ear canal pressure regulation device including a fluid flow generator, an earpiece having an axial earpiece bore, and a valved conduit fluidicly coupled to the fluid flow generator and the axial earpiece bore, whereby the earpiece has a compliant earpiece external surface configured to sealably engage an external ear canal as a barrier between an external ear canal pressure and an ambient pressure.
1 . (canceled)
2 . A fluid transfer device comprising:
an earpiece configured provide a barrier between an external ear canal pressure and an ambient pressure; and
a fluid flow generator being configured to generate a fluid flow through the earpiece to achieve an external ear canal pressure differential between the external ear canal pressure and the ambient pressure;
wherein the fluid transfer device has a first configuration in which the fluid flow generator is operable to increase the external ear canal pressure relative to the ambient pressure so as to generate a positive external ear canal pressure differential between the external ear canal pressure and the ambient pressure;
wherein the fluid transfer device has a second configuration in which the fluid flow generator is operable to decrease the external ear canal pressure relative to the ambient pressure so as to generate a negative external ear canal pressure differential between the external ear canal pressure and the ambient pressure.
3 . The fluid transfer device of claim 1 , wherein the external ear canal pressure differential is effective to treat a headache syndrome.
4 . The fluid transfer device of claim 1 , wherein the earpiece is configured to sealably engage an external ear canal wall to provide the barrier between the external ear canal pressure and the ambient pressure.
5 . The fluid transfer device of claim 1 , comprising a valve, wherein the fluid transfer device is in the first configuration when the valve is in a first position, and wherein the fluid flow generator is in the second configuration when the valve is in a second position.
6 . The fluid transfer device of claim 5 , wherein the valve comprises a unidirectional valve.
7 . An ear canal pressure regulation device, the device comprising:
an earpiece for insertion into an external ear canal, the earpiece being configured to sealably engage the external ear canal as a barrier between an external ear canal pressure and ambient pressure to maintain a seal between the earpiece and the external ear canal of the patient with a pressure differential between the external ear canal pressure and the ambient pressure; and
a pressure regulator that defines a flow rate of fluid between the earpiece and ambient environment outside the ear, the flow rate being defined to reduce the pressure differential between the external ear canal pressure and the ambient pressure over a period of time.
8 . The ear canal pressure regulation device of claim 7 , wherein the pressure differential between the external ear canal pressure and the ambient pressure is effective to alleviate headache pain.
9 . The ear canal pressure regulation device of claim 7 , wherein the earpiece comprises:
a first end;
a second end that is smaller than the first end, wherein a longitudinal axis extends from the first end to the second end;
an external surface that is tapered from the first end toward the second end and that has a truncated cone shape;
a plurality of circumferential ribs on the external surface of the earpiece, the plurality of circumferential ribs spaced apart between the first end and the second end of the earpiece; and
an axial earpiece bore extending along the longitudinal axis between the first end and the second end of the earpiece.
10 . The ear canal pressure regulation device of claim 7 , wherein the external ear canal pressure is higher than the ambient pressure to produce the pressure differential.
11 . The ear canal pressure regulation device of claim 7 , wherein the external ear canal pressure is lower than the ambient pressure to produce the pressure differential.
12 . The ear canal pressure regulation device of claim 7 , wherein the pressure regulator is configured to have a fluid flow rate through the pressure regulator of about 0.2 milliliters per second to about 20 millimeters per second.
13 . The ear canal pressure regulation device of claim 7 , the ear canal pressure regulation device is configured to increase or decrease the pressure differential between the external ear canal pressure and the ambient pressure a plurality of times while the earpiece of the ear canal pressure regulation device is sealably engaged with the external ear canal.
14 . An ear canal pressure regulation device, the device comprising:
an earpiece for insertion into an external ear canal of a patient;
a fluid flow pathway to provide fluid communication between the external ear canal and ambient environment outside the ear; and
a pressure regulator that defines a flow rate of fluid through the fluid flow pathway;
wherein the earpiece is configured to:
create a seal with the external ear canal as a barrier between an external ear canal pressure and ambient pressure;
maintain the seal with the external ear canal while a pressure differential between the external ear canal pressure and the ambient pressure increases during a first period of time; and
maintain the seal with the external ear canal while the pressure differential between the external ear canal pressure and the ambient pressure decreases during a second period of time after the first period of time;
wherein the pressure regulator permits fluid to flow at the flow rate through the fluid flow pathway to or from the ambient environment to decrease the pressure differential between the external ear canal pressure and the ambient pressure.
15 . The ear canal pressure regulation device of claim 14 , wherein the ear canal pressure regulation device is configured for treatment of headache pain.
16 . The ear canal pressure regulation device of claim 14 , wherein the earpiece has a truncated cone shape.
17 . The ear canal pressure regulation device of claim 14 , wherein the earpiece comprises a plurality of circumferential ribs.
18 . The ear canal pressure regulation device of claim 14 , wherein the earpiece is further configured to maintain a constant pressure differential between the external ear canal pressure and the ambient pressure for a third period of time between the first period of time and the second period of time.
19 . The ear canal pressure regulation device of claim 14 , wherein fluid flow through the pressure regulator has a flow rate of about 0.2 milliliters per second to about 20 millimeters per second.
20 . The ear canal pressure regulation device of claim 14 , wherein the ear canal pressure regulation device is configured to increase and decrease the pressure differential between the external ear canal pressure and the ambient pressure a plurality of times while the ear canal pressure regulation device is inserted in the external ear canal.