Ear protection device

Abstract

An ear protection device 1 comprising a housing 2 with a body 4 having a first end 6 configured in use to be placed within an ear of a user and an opposed second end 8. The body 4 comprises a formatio

Description

The invention relates to an ear protection device intended to reduce and / or prevent the effects of otic barotrauma. The ear protection device may be used to reduce and / or prevent the effects of otic barotrauma in pressurised aircraft. The invention also relates to an ear protection apparatus for storing and transporting at least one ear protection device. BACKGROUND OF INVENTION Many passengers feel discomfort or pain in their ears when in a pressurised aircraft, especially during the descent of the aircraft. The ear pain is caused as a result of a pressure difference between the outer ear and the middle ear. When the ear is working normally, the Eustachian tube which connects the middle ear to the back of the nose equalises the pressure between the middle ear and the outer ear. When the Eustachian tube A is blocked, as a result of for example congestion due to a head cold, the pressure in the middle ear can differ to that in the outer ear. In pressurised aircraft which cruise at altitudes typically from 30,000 to 41,000 feet, the cabin is pressurised to an equivalent of an altitude of 7,000 to 8,000 feet, but regulated at 10,000 feet maximum. During take-off and the main part of the flight, the pressure in the middle ear is able to equalise relative to the cabin pressure gradually. As the descent happens relatively rapidly, the change in cabin pressure once below 7,000 feet can be quite rapid, not allowing time for the middle ear pressure to equalise. Furthermore, if the Eustachian tube is blocked, there is a substantial pressure difference across the tympanic membrane (the ear drum) that separates the outer and middle ears. The pressure difference can cause a painful retraction of the tympanic membrane, the pain generally being caused by rupture of the small blood vessels in the ear. The condition and symptoms are generally referred to as otic barotrauma. In some cases, this can lead to the ear drum being perforated possibly leading to permanent ear damage. The size of the mastoid can vary between individuals. The mastoid is involved in the pressure buffering system along with the Eustachian tube. The varying size of the mastoid may account for the differences in reported experience between individuals. The anatomy of the Eustachian tube in infants and young children is different from adults. The Eustachian tubes run more horizontally from the middle ear to the nose, rather than as a downward sloping tube seen in adults. As a result of the horizontal course of the Eustachian tube, it is believed that infants / young children are more prone to middle ear infections and therefore more prone to otic barotrauma. There is a need for an ear protection device which can reduce or prevent pain associated with otic barotrauma. SUM MARY OF INVENTION According to a first aspect of the present invention, there is provided an ear protection device comprising a housing: a body having a first end configured in use to be placed within an ear of a user and an opposed second end, the body comprising a formation adjacent a second end thereof being configured in use to close off at least a part of the external auditory canal, and in which the body defines a cavity located therein and extending between the first and second ends of the body; a hydration fluid retaining member configured in use to be retained within the cavity of the body and to release hydration fluid therefrom; and a cap configured in use to engage and seal the second end of the body, in which the cap further comprises at least one engagement feature configured to engage the hydration fluid retaining member and to position the water retaining member at a predetermined location within the cavity of the body. When placed in the ear of a user, the external surface of the tympanic membrane is exposed to an elevated level of humidity due to the presence of the hydration fluid retention member which reduces the drying effect caused by the low humidity cabin air. This reduces or prevents the effects of otic barotrauma and therefore provide pain relief. At least one aperture is provided in the body allowing hydration fluid to be released from the device in the ear canal to help elevate the relative humidity that the outer surface of the tympanic membrane is exposed to, preferably to a humidity similar to that experienced on the ground. The aperture(s) is preferably provided at or adjacent the first end of the body of the housing. The size of the aperture may be selected to control the rate of release of hydration fluid from the hydration fluid retaining member to the outer surface of the tympanic membrane during use. Prior to use, the aperture(s) may be closed by for example a removable seal (i.e. removable film or cap) extending across the aperture(s). The seal is preferably removed prior to use (i.e. prior to insertion of the body into the ear). At least a portion of the body, for example at least the first end of the body, preferably comprises a relatively rigid portion. The cap and / or body may comprise a flexible, outwardly extending peripheral flange. The body may comprise a plurality of spaced apart flexible outwardly extending peripheral flanges. The flanges may be evenly spaced apart from each other along the length of the body. The formation (or a portion thereof) is preferably configured to close off (for example to form an air tight seal or water tight seal) at least part of the external auditory canal. The formation (or a portion thereof) may for example be configured to extend around the pinna of the ear so as to close off the whole outer ear. The formation (or a portion thereof) may be arranged to abut against the surface of the pinna around the entrance to the external auditory canal. The term "close off" is to be interpreted as providing an airtight seal and / or water tight seal and / or any restriction of air flow into and out of the external auditory canal that is sufficient to enable the relative humidity of that area to be increased by the hydration retaining member to provide a hydrating effect on the tympanic membrane. The body preferably tapers inwardly in a direction from the second end towards the first end of the body. The hydration retaining member may comprise a reservoir. In one embodiment, the reservoir is refillable. The reservoir may comprise a hydration fluid, such as for example water or other suitable hydrating fluids. The cap may be permanently engaged to the second end of the body. In one embodiment, the cap is configured in use to releasably engage the second end of the body. As such, the cap may be removed from the body when required in order, for example, to replace or refill the hydration retaining member located therein. The cap and body may be configured for snap fit or push fit engagement. The cap and body may be configured for threaded engagement. The housing preferably provides at least one retaining feature for securing the cap in position relative to the body, for example the second end of the body may provide at least one inwardly extending resilient tab at or adjacent the second end. The resilient tab may be configured in use to prevent unintentional removal of the cap from the body. In one embodiment, the periphery of the cap forms a watertight seal with the second end of the body. The cap is preferably shaped and dimensioned to abut against or extend around at least a portion of the outer ear. The cap preferably comprises an inner surface configured in use to be located adjacent the second end of the body and an opposed outer surface, and in which an aperture extends between the inner and outer surfaces thereof. The device partially blocks the outer ear and the aperture allows for a rapid equalisation in pressure between the device and the cabin. The engagement feature(s) of the cap is preferably configured in use to releasably engage a portion of the hydration fluid retaining member. The cap preferably comprises an inner surface located at or adjacent the second end of the body, and an opposed outer surface. The engagement feature(s) preferably extends away from the inner surface of the cap (for example in use, towards the first end of the body). The engagement feature is preferably located so as to align the hydration fluid retaining member with the cavity of the body. The hydration fluid retaining member is preferably a replaceable cartridge configured in use to be engaged by the engagement feature of the cap. The replaceable cartridge may have any suitable shape and dimensions. Preferably the replaceable cartridge is elongate in shape, for example tubular. The cartridge may for example be replaced with a further new cartridge when the hydration fluid has been used. The hydration fluid retaining member is preferably shaped and dimensioned to be positioned within the cavity of the body and spaced apart from inner surfaces of the body. For example, the hydration fluid retaining member may be elongate in shape, for example tubular. The hydration fluid retaining member preferably comprises absorbent material soaked in a hydration fluid, such as for example water. The absorbent material is preferably composed of one or more of: sponge, textile or an open cell foamed material, or any combination thereof. According to a second aspect of the present invention, there is provided an ear protection apparatus comprising: at least one ear protection device as herein described; and a storage compartment comprising a first portion defining at least one chamber, in which the or each chamber is configured in use to receive the at least one ear protection device together with a hydration fluid therein, and a second portion configured in use to extend across and seal at least one chamber of the first portion, in which the first and second portions of the storage compartment are moveable between an open position providing user access to the at least one chamber of the first portion; and a closed position in which the second portion of the storage compartment forms a water tight seal around the at least one chamber. The storage compartment may be single-use (i.e. disposable). Alternatively, the storage compartment may be configured for repeated use (i.e. reusable). The first and second portions may be configured for repeatable, releasably engagement such that the storage compartment may be reused. The first portion may be connected to the second portion by a hinge along one edge thereof. The storage compartment may be configured for single use such that when moved from the closed position to the open position, the second portion cannot be re-engaged to the first portion. For example, the first and second portions may be secured to each other in the closed position by a suitable sealant or adhesive. The apparatus may comprise a plurality of storage compartments. The storage compartments may be detachable from adjacent storage compartments. Lines of weakness, such as for example perforations, slits, scored lines, may extend between adjacent storage compartments facilitating detachment. The apparatus may comprise a plurality of storage compartments in any suitable arrangement. For example, one or more lines of weakness may be provided between adjacent first portions of the compartments. One or more lines of weakness may be provided between adjacent second portions of the compartments. The apparatus may further comprise a source of hydration fluid for use with the storage compartment. The source of hydration fluid may be a container (such as a bottle or ampoule). The at least one chamber is preferably shaped and contoured to hold the at least one ear protection device in a predetermined position within the storage compartment. The chamber(s) is preferably configured to retain an ear protection device in position spaced apart from a further ear protection device. The at least one chamber is preferably shaped and dimensioned to receive at least the first end of the body of the housing therein together with a hydration fluid. In one embodiment, each chamber is shaped and dimensioned to retain a pair of ear protection devices therein and a hydration fluid, such as for example water. For example, each chamber is shaped and dimensioned to provide a reservoir for the hydration fluid, the reservoir being configured in use to be in communication with portions of the cavity which are configured to retain at least one ear protection device. The chamber may comprise a plurality of, for example two, spaced apart tapered chamber portions, each portion configured in use to receive an ear protection device upstanding therein, and a connecting reservoir (for example channel) extending between the spaced apart tapered chamber portions so as to ensure an even distribution of the hydration fluid received within the chamber. The storage compartment, or a portion thereof, such as for example the first portion, may be formed by injection moulding. The first portion preferably comprises a first end defining an opening into the chamber, and an opposed second end at or adjacent the base of the chamber. In one embodiment, the chamber tapers inwardly in a direction from the first end towards the second end of the first portion. The tapering corresponds to the tapering of the body of the ear protection device such that the first portion is configured to support the or each ear protection device in an upstanding position within the chamber. The chamber of the first portion may further comprise a retaining portion, for example a groove, slot or protrusion, configured to engage at least the first end of the body of the ear protection device to ensure that the device is held in a predetermined position within the chamber. The second portion may for example be a film layer configured in use to extend across and substantially seal the opening of the first portion. The film layer may be a barrier film layer preventing the passage of water and oxygen therethrough. The film layer preferably meets predetermined water and oxygen transmission criteria. A seal, preferably a heat seal, is preferably formed between the second portion and the first portion to effectively seal the chamber from the external environment. For example the periphery of the first portion is preferably heat sealed to the periphery of the second portion. Preferably the seal is effective to withstand variations in air pressure, such as for example experienced during air travel. The seal formed between the first and second portions is preferably configured to be able to be manually peeled apart by a user. The film preferably has sufficient strength to not tear during removal or separation by a user. In one embodiment, the second portion may comprise a further chamber configured to retain a portion of the cap of the device therein. The chamber of the second portion may be configured to form a push fit or snap fit engagement with the cap of the device. As such, the chamber of the second portion provides for a predetermined alignment of the device prior to insertion into the chamber (containing the hydration fluid) of the first portion. At least one of the first and / or second portion is preferably transparent. For example, the second portion may be a transparent film layer. One or more of the first and / or second portions may be composed of PET. According to a further aspect, there is provided a method for the manufacture of an ear protection device as described herein, the method comprising: obtaining a body having a first end configured in use to be placed within an ear of a user and an opposed second end, the body comprising a formation adjacent a second end thereof being configured in use to close off at least a part of the external auditory canal, and in which the body defines a cavity located therein and extending between the first and second ends of the body; obtaining a cap configured in use to engage and seal the second end of the body, in which the cap further comprises an engagement feature configured to engage a hydration retaining member; engaging a hydration retaining member with the engagement feature of the cap; using the cap to insert and position the hydration retaining member at a predetermined location within the cavity of the body; and engaging the cap with the second end of the body to form a seal. According to a further aspect of the present invention, there is provided a method for the manufacture of an ear protection apparatus as described herein, the method comprising: obtaining at least one ear protection device as herein described; obtaining storage compartment comprising a first portion defining at least one chamber, in which the or each chamber is configured in use to receive the at least one ear protection device together with a hydration fluid therein, and a second portion configured in use to extend across and seal at least the at least one chamber of the first portion, in which the storage compartment is placed in an open position in providing user access to the at least one chamber of the first portion; inserting hydration fluid into the or each chamber of the first portion of the storage compartment; inserting the at least one ear protection device into the or each chamber of the first portion of the storage compartment; and placing the storage compartment in a closed position in which the second portion of the storage compartment forms a water tight seal around the at least one chamber. One or more of the body and / or cap may be formed by injection moulding. The method may comprise providing a sealing film between the first and second portions. The sealing film is preferably a layered polymer film configured to provide a water vapour barrier between the storage compartment (in the closed position) and the atmosphere. Preferably, the hydration fluid is absorbed, preferably immediately absorbed, on contact with the at least one ear protection device. Embodiments of the present invention will now be described in more detail with reference to the accompanying Figures: BRIEF DESCRIPTION OF FIGURE Figure 1 is a schematic illustration of a side view of an ear protection device according to one embodiment of the present invention; Figure 2 is a schematic illustration of a rear view of the ear protection device of Figure 1; Figure 3 is a schematic illustration of a view from above of the ear protection device of Figure 1; Figure 4 is a schematic illustration of a view from below of the ear protection device of Figure 1; Figure 5 is a schematic illustration of a cross-sectional view of the ear protection device of Figure 1; Figure 6 is a photograph of a top view of an ear protection apparatus according to one embodiment of the present invention containing two pairs of ear protection devices of Figure 1; and Figure 7 is a photograph of a bottom view of the ear protection apparatus of Figure 6. DETAILED DESCRIPTION With reference to Figures 1 to 5, the ear protection device 1 comprises a housing 2. The housing 2 comprises a body 4 having a first end 6 configured in use to be placed within an ear of a user and an opposed second end 8. The body 4 tapers inwardly in a direction from the second end 8 to the first end 6. In the illustrated embodiment, there are two outwardly extending annular flanges positioned between the first and second ends of the body 4. It is to be understood that the body 4 may comprise any suitable number of outwardly extending flanges. The body 4 comprises a formation 10 adjacent the second end 8 thereof being configured in use to close off at least a part of the external auditory canal. In the illustrated embodiment, the formation 10 is in the form of an annular flange having a greater cross-sectional dimension than the first end 6. The body 4 defines a cavity 12 located therein and extending between the first 6 and second 8 ends of the body 4. The device 1 further comprises a hydration fluid retaining member 14 configured in use to be retained within the cavity 12 of the body 4. The housing 2 further comprises a cap 16 configured in use to engage and seal the second end 8 of the body 4. The periphery of the cap 16 preferably forms a water tight and / or air tight seal with the second end 8 of the body 4. The cap 16 is shaped and dimensioned to abut against or extend around at least a portion of the outer ear. The cap 16 has a greater cross-sectional dimension than the body 4. The cap 16 further comprises an engagement feature 18 configured to engage the hydration fluid retaining member 14 and to position the hydration fluid retaining member 14 at a predetermined location within the cavity 12 of the body 4. The cap 16 has an inner surface 20 configured in use to be positioned at or adjacent the second end 8 of the body 4 and an opposed outer surface 22. The engagement feature 18 is upstanding from the inner surface 20 of the cap 20. The engagement feature 18 is substantially aligned with the cavity 12 of the body 4. An aperture 24 extends between the inner 20 and outer 22 surfaces of the cap 16 facilitating slower pressure equalisation between the device and the cabin (ie. between the middle ear and the outer ear). A further aperture 26 is provided at the first end 6 of the body 4. The aperture 26 is in communication with the cavity 12. The aperture 26 allows hydration fluid to be released from the device 1 towards the outer surface of the tympanic membrane. The size of the aperture may be selected to control the release of hydration fluid from the hydration fluid retaining member to the outer surface of the tympanic membrane during use. Prior to use, the aperture may be closed by for example a removable seal (i.e. removable film or cap). In the illustrated embodiment, the cap 16 is configured in use to releasably engage the second end 8 of the body 4. It is however to be understood that in some embodiments, the cap may permanently engage the body 4. In the illustrated embodiment, the engagement feature 18 of the cap 16 is configured in use to releasably engage a portion of the hydration fluid retaining member 14. As such, the hydration fluid retaining member 14 can be replaced with a new hydration fluid retaining member 14 as required such that the device may be reused. It is however to be understood that in some embodiments, the hydration fluid retaining member 14 may be permanently engaged to the engagement feature 18 of the cap 16. The hydration fluid retaining member 14 comprises absorbent material soaked in hydration fluid. The absorbent material may be composed of one or more of: sponge, textile or an open cell foamed material, or any combination thereof. The hydration fluid may be water or saline solution or any other suitable hydration fluid. With reference to Figures 6 and 7, the ear protection apparatus 26 comprises two pairs of ear protection devices 1 as described herein. The apparatus 26 further comprises a pair of adjoined storage compartments 28. The storage compartments 28 are formed by injection moulding. The storage compartments may be adjoined to each other by a line of weakness to enable easy separation by the user. Each storage compartment 28 comprises a first portion 30 defining a chamber 32. Each chamber 32 is configured in use to receive a pair of ear protection devices 1 together with hydration fluid (not shown) therein. The storage compartment 28 further comprises a second portion 34 configured in use to extend across and seal the underlying chamber 32 of the first portion 30. The first 30 and second 34 portions of the storage compartment 28 are moveable between an open position providing user access to the chamber 32 of the first portion 30; and a closed position in which the second portion 34 of the storage compartment 28 forms a water tight seal around the chamber 32. The chamber 32 is shaped and contoured to hold the ear protection devices 1 in a predetermined position within the storage compartment 28. Each chamber 32 is shaped and dimensioned to provide a reservoir for the source of hydration fluid, the reservoir being configured in use to be in communication with both ear protection devices 1. Each chamber 32 comprises two spaced apart tapered chamber portions 32a, 32b, each portion 32a, 32b configured in use to receive an ear protection device 1 upstanding therein, and a connecting channel 32c extending between the two spaced apart tapered chamber portions 32a, 32b. The first portion 30 comprises a first end (not shown) defining an opening into the chamber 32, and an opposed second end (not shown) at or adjacent the base of the chamber 32. The chamber 32 tapers inwardly in a direction from the first end towards the second end of the first portion 30. The tapering corresponds to the tapering of the body of the ear protection device 1 such that the first portion 30 is configured to support the or each ear protection device in an upstanding position within the chamber 32. In use, the user separates the second portion 34 from the first portion 30 to access the chamber 32 and remove the pair of ear protection devices 1 which are pre-loaded with hydration fluid present within the chamber 32. The user places the first end of the body 4 into the ear. When the ear protection device 1 is placed in the ear of a user, the external surface of the tympanic membrane is exposed to an elevated level of humidity, due to the presence of the hydration fluid retaining member 14, which reduces the drying effect caused by the low humidity cabin air. This is believed to reduce or prevent the effects of otic barotrauma and therefore provide pain relief. Testing by the applicant has shown that the device is able to maintain an elevated relative humidity in a volume similar to the ear canal. A further clinical trial has evidenced that the device alleviates and prevents ear pain. The user may separate the cap 16 from the body 4 in order to refresh the hydration fluid retaining member 14. On separation, the user may remove the hydration fluid retaining member 14 and replace with a new hydration fluid retaining member 14 (or soak the hydration fluid retaining member 14 in further hydration fluid). The user may then insert the hydration fluid retaining member 14 into the cavity 12 of the body 4 and secure the cap 16 in position. The device 1 may then be inserted into the ear. The use of a cap to position the hydration fluid retaining member 14 within the body leads to improved accuracy of alignment and positioning and reduces the risk of contamination as the user does not contact the member 14 directly.

Claims

1. An ear protection device comprising a housing comprising:a body having a first end configured in use to be placed within an ear of a user and an opposed second end, the body comprising a formation adjacent a second end thereof being configured in use to close off at least a part of the external auditory canal, and in which the body defines a cavity located therein and extending between the first and second ends of the body;a hydration fluid retaining member configured in use to be retained within the cavity of the body; anda cap configured in use to engage and seal the second end of the body, in which the cap further comprises an engagement feature configured to engage the hydration fluid retaining member and to position the hydration fluid retaining member at a predetermined location within the cavity of the body.

2. An ear protection device as claimed in claim 1, in which the hydration fluid retaining member comprises a reservoir.

3. An ear protection device as claimed in claim 2, in which the reservoir is refillable.

4. An ear protection device as claimed in claim 3, in which the cap is configured in use to releasably engage the second end of the body.

5. An ear protection device as claimed in any one of claims 1 to 4, in which the engagement feature of the cap is configured in use to releasably engage a portion of the hydration fluid retaining member.

6. An ear protection device as claimed in claim 5, in which the hydration fluid retaining member is a replaceable cartridge configured in use to be engaged by the engagement feature of the cap.

7. An ear protection device as claimed in any one of claims 1 to 6, in which the hydration fluid retaining member comprises absorbent material soaked in hydration fluid.

8. An ear protection device as claimed in claim 7, in which the hydration fluid retaining member comprises absorbent material composed of one or more of: sponge, textile or an open cell foamed material, or any combination thereof.

9. An ear protection device as claimed in any one of claims 1 to 8, in which the periphery of the cap forms a water tight and / or air tight seal with the second end of the body.

10. An ear protection device as claimed in any one of claims 1 to 9, in which at least the first end of the body comprises a relatively rigid portion.

11. An ear protection device as claimed in any one of claims 1 to 10, in which the cap is shaped and dimensioned to abut against or extend around at least a portion of the outer ear.

12. An ear protection device as claim in any one of claims 1 to 11, in which the cap comprises an inner surface configured in use to be located adjacent the second end of the body and an opposed outer surface, and in which an aperture extends between the inner and outer surfaces thereof.

13. An ear protection apparatus comprising:at least one ear protection device as claimed in any preceding claim;a storage compartment comprising a first portion defining at least one chamber, in which the or each chamber is configured in use to receive the at least one ear protection device together with hydration fluid therein, and a second portion configured in use to extend across and seal at least the at least one chamber of the first portion,in which the first and second portions of the storage compartment are moveable between an open position providing user access to the at least one chamber of the first portion; and a closed position in which the second portion of the storage compartment forms a water tight seal around the at least one chamber.

14. An ear protection apparatus as claimed in claim 13, in which the at least one chamber is shaped and contoured to hold the at least one ear protection device in a predetermined position within the storage compartment.

15. An ear protection apparatus as claimed in claim 14, in which the at least one chamber is shaped and dimensioned to receive at least the first end of the body of the housing therein together with a hydration fluid.

16. An ear protection apparatus as claimed in any one of claims 13 to 15, in which each chamber is shaped and dimensioned to retain a pair of ear protection devices therein and a hydration fluid.

17. An ear protection apparatus as claimed in claim 16, in which each chamber is shaped and dimensioned to provide a reservoir for the source of hydration fluid, the reservoir being configured in use to be in communication with both ear protection devices.

18. A method for the manufacture of an ear protection device as claimed in any one of claims 1 to 12, the method comprising:obtaining a body having a first end configured in use to be placed within an ear of a user and an opposed second end, the body comprising a formation adjacent a second end thereof being configured in use to close off at least a part of the external auditory canal, and in which the body defines a cavity located therein and extending between the first and second ends of the body;obtaining a cap configured in use to engage and seal the second end of the body, in which the cap further comprises an engagement feature configured to engage a hydration retaining member;engaging a hydration retaining member with the engagement feature of the cap;using the cap to insert and position the hydration retaining member at a predetermined location within the cavity of the body; andengaging the cap with the second end of the body to form a seal.

19. A method for the manufacture of an ear protection apparatus as claimed in any one of claims 13 to 18, the method comprising:obtaining at least one ear protection device as claimed in any one of claims 1 to 12;obtaining storage compartment comprising a first portion defining at least one chamber, in which the or each chamber is configured in use to receive the at least one ear protection device together with a hydration fluid therein, and a second portion configured in use to extend across and seal at least the at least one chamber of the first portion, in which the storage compartment is placed in an open position in providing user access to the at least one chamber of the first portion;inserting hydration fluid into the or each chamber of the first portion of the storage compartment;inserting the at least one ear protection device into the or each chamber of the first portion of the storage compartment; andplacing the storage compartment in a closed position in which the second portion of the storage compartment forms a water tight seal around the at least one chamber.

Images