HK1070532B - Expandable in-ear device - Google Patents

Description

Expandable in-ear device

Technical Field

The present invention relates generally to in-ear devices, such as earplugs, hearing aids, and the like, and more particularly to custom fitting in-ear devices that are made in situ so as to very suitably assume the shape of the custom wearer's ear canal and interior of the ear cavity.

Background

Hearing Protection Devices (HPDs) are generally passive (i.e., unpowered), somewhat similar to earplugs, while more complex (but still passive) HPDs may include a sound chamber and a filter to pass or attenuate selected frequencies.

The term "hearing device" includes active devices (active devices) having either hearing protective or hearing assistance capabilities, in which some or all of the batteries and other components are mounted in a behind-the-ear enclosure or remotely, which communicates with an in-ear device via a sound tube or wire; and includes active devices in which the microphone, speaker and all associated sound processing circuitry and components, including batteries, are housed in the in-the-ear unit.

A recent trend in digital hearing devices seeks to overcome the traditional fitting conflict problem by providing multiple sound transmissions.

The prospect of quickly achieving a good fit each time provides new incentives for the audio side of hearing assistance (and hearing protection) technology.

It is recognized that the performance of all in-ear hearing devices is highly dependent on the fit of the device in the ear. If the HPD does not fit well, the sound only passes around the HPD. The HPD tends to be too tight, resulting in poor wearing comfort and therefore the wearer does not want to wear this HPD for a long period of time.

A recent development in hearing assistance has been to reduce the need for a good fit by eliminating reverberation.

Different in-ear devices are currently used in many aspects of human life. HPDs are similar to hearing assistance devices from a performance standpoint and do require customization.

United states patent 5,006,055 issued to Lebisch et al at 8/4 of 1989 discloses an apparatus for manufacturing an in-ear device directly in the ear of a person with poor hearing by fitting a deformable sleeve over a mold or shell or over a laminated shell. This rather lengthy process requires many assembly steps.

U.S. patent 5,333,622 issued on 8/2 of 1994 to Casail et al and 5,131,411 issued on 7/21 of 1992, respectively, disclose custom-molded earplugs that can be used to select earplugs of predetermined dimensions or as molds for making earplugs or hearing aids. This earplug is not suitable for a custom fit in situ to the ear canal of a user.

Canadian patent application 2,302,962/a1, filed on 23.3.2000 and published on 26.9.2000 by Mclntosh et al, discloses a hearing device using a distending media and adapted for in situ distension. The device includes a core portion that is generally covered by a separate covering. The correct installation of the capsule requires extremely delicate operations, in particular when the distal end of the capsule is connected to the core using a remote seal, while not interfering with the sound tube.

Disclosure of Invention

It is therefore a general object of the present invention to provide an expandable in-ear device that overcomes the above-mentioned deficiencies.

One advantage of the present invention is that a user may repeatedly insert an expandable in-ear device properly into the ear.

Another advantage of the present invention is that the expandable in-ear device is molded as a single piece.

Still another advantage of the present invention is the customization of expandable in-ear devices to the needs of the user, to earplugs, filter earplugs, hearing assistance devices, communication devices, and the like.

Yet another advantage of the present invention is that the expandable in-ear device is comfortable for the user.

Yet another advantage of the present invention is that the expandable in-ear device may be adapted for a one-sided specific use, either a left-sided or a right-sided device.

Yet another advantage of the present invention is that the expandable in-ear device can be customized to removably receive any type of communication device therein, as desired by the user.

According to the present invention there is provided an expandable in-ear device for implantation in the ear canal of a human being and in-situ customised to fit the shape of the ear canal of a user using a settable compound, the in-ear device comprising:

a core member formed with a protruding portion that can be inserted into an ear canal;

a first sound hole extending from an ear canal outer position to an ear canal inner position through the protruding portion for transmitting sound therein; and

a deformable covering extending integrally from the core, the deformable covering being deformable between an expanded configuration and a collapsed configuration of the in-ear device, wherein when the covering is in the expanded configuration the covering extends away from the protruding portion while remaining attached to the core, the covering being foldable from the expanded configuration to the collapsed configuration in an inside-out manner, wherein the covering is in an overlapping relationship with respect to the core so as to cover the protruding portion while defining a space between the covering and the core, the space being fillable with a settable compound.

Typically, the core-member further defines a platform portion defining a platform distal end and a platform proximal end opposite the platform distal end, the projection portion extends from the platform proximal end, the projection portion defines a projection distal end adjacent the platform proximal end and a projection proximal end opposite the projection distal end;

the sheath integrally extends from the location of the proximal end of the projection when the in-ear device is in the expanded configuration and the sheath is in overlapping relation with respect to the core member to cover the projection portion and the platform portion when the in-ear device is in the collapsed configuration, the sheath defining an aperture therethrough that overlies the distal end of the platform when the in-ear device is in the collapsed configuration.

Typically, the platform distal end has a platform distal end perimeter forming a platform protrusion surface protruding therefrom, and the sheath aperture has a shape presenting a perimeter of the platform protrusion surface.

Typically, the first soundhole extends from a location within the ear canal proximal to the protrusion to a location outside the ear canal distal to the platform.

In one embodiment, when the in-ear device is in the folded configuration, the sheath tightly covers the core and the space is free of fluid.

In one embodiment, the in-ear device is made from a single molded piece.

In one embodiment, the sleeve body bore has a bore perimeter reinforced by a protuberance integrally extending from the sleeve body to mate with a corresponding groove on the perimeter of the platform protuberance surface distal from the platform to seal the gap.

In one embodiment, the platform portion includes a cavity extending inwardly from a location near the distal end of the platform, and the in-ear device further includes an insert member movably engaged with the cavity of the platform portion; and a second acoustic port extending from the raised portion proximal location through the raised portion and the platform portion to the cavity of the platform portion for transmitting sound therein.

In one embodiment, the insert member is a plug member to seal the second acoustic port so that the in-ear device is an earplug device.

In one embodiment, the insert member includes a communication member for communicating sound with the second sound hole.

In one embodiment, the communication component is a band pass filter for passing an acceptable frequency range into the ear canal, so that the in-ear device is a filtering earplug device.

Preferably, the communication member is a second chamber extending inwardly into the insertion member for releasable engagement with an electrical circuit that amplifies sound in a predetermined frequency range and transmits it from outside the ear canal to the second sound hole, whereby the in-the-ear device is a hearing aid device.

Preferably, the communication member is a sound hole extension through the insertion member, which sound hole extension communicates with the second sound hole at its proximal end and is adapted to engage with an external hearing aid device at its distal end, whereby the in-the-ear device is a hearing aid adjustment device.

In one embodiment, the distal end of the first soundhole is located within the platform protrusion surface of the platform portion and is closed and stopped by the elongated membrane as long as the remote device is not inserted therein.

In one embodiment, the device further comprises a handle member secured in a position distal to the platform.

In one embodiment, the handle member is affixed to the platform portion of the core member.

Typically, the in situ handle member includes teeth that engage corresponding recesses on the platform portion for properly positioning the handle member relative to the core member, the handle member having a bore extending longitudinally therethrough for guiding the injection device containing the settable compound to a slot-like slot in the platform portion, the slot-like slot communicating with the space for allowing the settable compound to flow from the slot-like slot into the space.

In one embodiment, the opening in the handle member is sealed by a membrane in contact with the core member.

In one embodiment, the slit-shaped slot is closed on itself as the injection device is withdrawn therefrom.

In one embodiment, the distal end of the platform is formed with a convex shape having an extended apex and being symmetrical thereto, the convex shape forming two planar surfaces with the extended apex forming a common distal edge between the two surfaces, the planar surfaces extending away from each other from the common distal edge and towards the proximal end of the platform.

Typically, one of the two surfaces has a platform distal perimeter defining a protruding platform projection surface, the cuff aperture has a shape that assumes the perimeter of the platform projection surface, and the other of the two surfaces is completely covered by the cuff when in a folded configuration and is customized in situ to the shape of the human ear chamber corresponding to the ear canal.

Other objects and advantages of the present invention will become more apparent upon careful reading of the following detailed description with appropriate reference to the accompanying drawings.

Drawings

In the drawings, like reference numerals refer to like parts.

FIG. 1 is an exploded side view of one embodiment of an expandable in-ear device according to the present disclosure, showing a sheath integrally extending over a core in an expanded configuration;

FIG. 2 is a bottom view of the embodiment of FIG. 1;

FIG. 3 is a side view of the embodiment of FIG. 1, with the sheath folded over the core from the inside out in a folded configuration;

FIG. 4 is a bottom view of the embodiment of FIG. 2;

FIG. 5 is an enlarged fragmentary cross-sectional view taken along line 5-5 of FIG. 3, showing the handle member secured to the platform portion;

FIG. 6 is an enlarged cross-sectional view taken along line 6-6 of FIG. 3;

FIG. 7 is a cross-sectional view of the embodiment of FIG. 2 inserted into the ear cavity and ear canal of a user and utilizing a settable compound material and its splaying to perfectly assume the shape of the ear cavity and ear canal; and

FIG. 8 is a perspective view of another embodiment of an insert member engaging a cavity.

Detailed Description

Preferred embodiments of the invention are described below in a figurative and non-limiting manner with reference to the accompanying drawings.

Referring to fig. 1-8, an embodiment of an expandable in-ear device 10 according to the present invention is shown. The device 10 is adapted to be custom fit in situ, conforming to the shape of the ear canal C and ear cavity V of the user, by injecting a settable compound material 23 into the ear canal C and ear cavity V. The device 10 includes a core 20 having a nucleated shape that forms a platform portion 30 and a protrusion portion 40. The platform portion 30 that substantially fits within the ear cavity V forms a platform distal end 32 and a generally opposed platform proximal end 31 that forms a platform distal perimeter 34. The protruding portion 40 substantially fitting into the ear canal C forms a protruding distal end 43 and a substantially opposite protruding proximal end 41. A protruding portion 40 extends integrally from the platform proximal end 31 for engaging the ear canal C. The sound hole 21 generally extends from the protrusion proximal end 41 to the platform distal end 32, through the protrusion portion 40 and the platform portion 30, for conducting ambient sound external to the ear canal C to the interior of the ear canal C.

In the expanded configuration of the device 10, as shown in fig. 1, the stretchable sheath 50 is integrally bonded to and extends away from the raised proximal end 41 of the core 20. The sheath 50 is formed in a sheath shape that substantially mirrors the shape of the core 20. The sheath 50 is configured and dimensioned to substantially assume the shape of the core-form when folded inwardly and outwardly over the core-form 20 in the folded configuration of the device 10, in a generally overlying relationship with respect to the core-form 20 so as to completely cover the core-form. The inner sheath 50 also forms an inner region 22 between the sheath and core in the folded configuration, as shown in FIG. 3. The sheath 50 has a sheath aperture 51 that substantially receives the platform distal perimeter 34.

The platform portion 30 allows for the settable compound material 23 to be injected therethrough to reach and fill the interior region 22 therebetween and to stretch the sheath 50 away from the core-form member 20, thereby expanding the device 10 that fits within the ear canal C to substantially assume the shape of the latter and the ear canal V and seal it thereto, thereby forming an integral component with the device 10 after the settable compound material 23 has been fully injected. The interior region 22 does not communicate with the sound hole 21 therebetween for reasons well known to those skilled in the art.

The in-ear device 10 also preferably includes a handle member 60 that is preferably adhesively secured to the platform distal end 32. The device 10 includes a handle positioning means for positioning the handle 60 relative to the platform portion 30. To properly position the handle 60 relative to the core member 20, the handle 60 is preferably provided with teeth 61 for engaging corresponding splines 33 on the platform portion 30, the teeth 61 and splines 33 forming handle positioning means, as shown in FIG. 5.

To ensure better flow of the settable compound material 23 within the interior region 22 between the two devices 10, the platform proximal end 31 includes a preferably semi-annular groove 35 adjacent the raised portion 40, as shown in fig. 1. To allow the compound material 23 to pass from the distal end 32 of the platform 30 to the interior region 22 therebetween through the semi-annular groove 35, a communicating injection throat 36 extends substantially through the platform portion 30 in fluid communication with the interior region 22 therebetween between the platform distal end 32 and the semi-annular groove 35. The injection throat 36, which is preferably linear, releasably receives an injection device, such as a needle N of a syringe S, containing settable compound material 23. Obviously, the injection throat 36 is made by penetrating the platform 30 with a sharp tool before the envelope 50 is folded over the core 20, so that the envelope 50 is not damaged.

The handle 60 is generally elongated and preferably defines a longitudinal access aperture 62 aligned with the injection slit 36 for selectively guiding the penetration tool and needle N of the syringe S (shown in fig. 7).

The bore 62 of the handle 60 preferably includes a sealing membrane 63 at its proximal end that contacts the core 20 to prevent any backflow of adhesive within the bore 62 when the handle 60 is bonded to the platform 30. Similarly, to prevent any backflow of settable compound material 23 immediately after injection of settable compound material into the interior region 22 therebetween, it is preferred that the injection slit 36 be self-sealing once the injection needle N is withdrawn therefrom.

As shown in FIG. 7, the platform distal perimeter 34 defines a platform raised surface 37 that projects slightly outwardly from the platform distal end 32 and defines a raised surface perimeter. Thus, the sleeve aperture 51 is shaped to receive the surface perimeter of the platform ledge 37. Preferably, the sleeve body aperture 51 is reinforced at its periphery with a projection 52 integral therewith for closely engaging a corresponding groove 38 on the periphery of the platform nose surface 37. The sleeve bore protuberance 52 is preferably bonded (or glued) to the groove 38 in the platform protuberance surface 37 so as to substantially seal the interior region 22 therebetween. The distal end 21d of the sound hole 21 is located within the platform protrusion surface 37, preferably closed off by an elongated membrane 24 temporarily sealed thereto, as long as no remote means (not shown) such as a microphone of the measuring device is releasably inserted therein.

And as shown in fig. 2 and 6, the platform distal end 32 is preferably formed in a generally convex shape with an extended tip 26 and is generally symmetrical about the tip 26. The protrusion shape forms two substantially flat surfaces 25 with a tip 26 forming a common distal edge between the two surfaces. The two planar surfaces 25 extend generally downwardly and are spaced from one another from a common distal edge 26 in a proximal direction toward the platform proximal end 31. Only one of the flat surfaces 25 includes the platform distal perimeter 34 forming the platform raised surface 37 while the other flat surface is completely covered by the sheath 50 in the folded configuration of the in-ear device 10 to form part of the intermediate interior region 22 that is custom fitted in situ to the user's ear cavity V to best reflect its shape. Obviously, the sleeve body holes 51 are located on the same side of the corresponding projection surface 37. The slope of the protrusion shape forming the flat surface 25 allows the device 10 to be dedicated to one side, either left or right side, with only the handle 60 secured to the protruding surface 37 protruding out of the user's ear.

Moreover, due to the generally conical nature required for the protruding portion 40 to be inserted into the ear canal C, the device 10 requires a retainer to prevent it from slipping out of the ear canal C. Thus, the side of the platform 30 that is completely covered by the covering and has the flat surface 25 is shaped and dimensioned to be able to be seated in the ear cavity V and provide the required retention force.

After the handle 60 is installed and the injection throat 36 is formed, the sheath 50 is gradually folded over the core 20 from the inside out. Preferably, the sheath 50 tightly surrounds the core 20 such that the interior region 22 is substantially impermeable to fluid and no air enters therein. For safety reasons, after folding the envelope body 50, its hole 51 is connected around the protruding surface 37, and then the inner region 22 is generally evacuated to remove the air entering therein. At this point, the device 10 is ready for insertion into the ear canal C and a settable compound material 23 is injected into the interior region 22 to custom fit the in-ear device 10 in situ, as shown in FIG. 7. The sheath 50 is then pulled away from the core-piece 20 to perfectly assume the shape of and close the ear canal C. Similarly, the retainer region of the device 10 also causes a portion of its interior region 22 filled with settable compound material to simultaneously expand, thereby perfectly assuming the shape of the user's ear cavity V. The device 10 is then removed from the ear canal C after the compound material 23 has set sufficiently.

The core-shaped member 20 is generally solid and sufficiently rigid to have substantially inherent structural rigidity, while the tensile jacket 50 is a thin material having substantially no inherent structural rigidity, both of which are preferably formed as a one-piece molded member from a silicone type material or the like, preferably having a durometer value below thirty (30) shore a. Thus, as shown in fig. 1, currently, the nucleated protrusion 42 at the protrusion proximal end 41 is preferably used only for molding purposes of the sound holes 21, 28. After the envelope 50 is folded over, the nucleated protrusion is preferably cut away as shown in figures 3 and 4. The settable compound material 23 is preferably a rubber-like form material having a durometer value preferably below thirty (30) shore a once it has been sufficiently cured.

Furthermore, in view of the fact that the material of the core member 20 is substantially resilient, the platform portion 30 of the in-ear device 10 preferably forms a cavity 27 for removably, snugly and at least partially receiving the insert member 70. The cavity 27 extends substantially inwardly from the raised surface 37. The core member 20 also defines a second sound hole 28 that extends generally through the protruding portion 40 and the platform portion 30 from the protruding proximal end 41 to the cavity 27 of the platform 30 to communicate sound between the cavity 27 and the interior of the ear canal C such that the insert member 70 can communicate sound with the interior of the ear canal C. The second acoustic port 28 is substantially parallel to the first acoustic port 21 except in the region near the distal end 32 of the platform where the two acoustic ports are slightly separated from each other.

The chamber preferably includes insert retaining means for releasably retaining the insert member 70 within the chamber. The insertion retention means is preferably formed by a lower portion of the handle 60 defining a step for releasably engaging a complementary locking step 71 of the insertion member 70.

Both the handle 60 and the insert 70 are preferably made of a silicone type material or the like, typically having a durometer value between fifty (50) and eighty (80) shore a.

As shown in fig. 1-7, the insert member 70 may be a plug member to simply seal the second acoustic port 28, while the in-ear device 10 is a typical earplug device.

Alternatively, the insert member 70 includes a communication member 72 for communicating with the second acoustic port 28. Thus, the communication component 72 may be a band pass filter, preferably in a form that extends sufficiently to the dimensions of the second soundhole 28 for the receivable frequency range to reach inside the ear canal C, such that the in-ear device 10 is a typical filtering earplug device.

Also, as shown in fig. 8, the communication component 72 of the insertion component 70a may be an insertion cavity 73 adapted to releasably engage an electrical circuit (not shown and well known in the art) or the like for amplifying and transmitting sound in a predetermined frequency range from the environment outside the ear canal C to the second sound hole 28, such that the in-ear device 10 is a typical hearing assistance device, more commonly known as an in-the-ear (ITE) hearing aid. Likewise, the communication member 72 may be a simple soundhole extension (not shown) adapted to engage an external hearing assistance device, such as a known behind-the-ear (BTE) hearing aid or the like, at its distal end and communicate with the second soundhole 28 at its proximal end, such that the in-ear device 10 is a typical hearing assistance accommodating device.

Alternatively, the communication component 72 or just the insertion component 70 may be a simple wireless or wired audio output connector, outputting from a typical electronic device adapted to releasably fit within the insertion cavity 73, such as a computer, laptop computer, cellular (or mobile telecommunications GSM-global system) phone, handheld (palm) computer, or the like.

To prevent a user from releasing his/her in-ear device 10 when a pair of in-ear devices 10 of the present invention are damaged, each of the apertures 62 of the two handles 60 may be releasably engaged by a respective resilient latch member (not shown) secured to a respective end of a core or the like to secure the two devices 10 together.

While the expandable in-ear device of the present invention has been described with a certain degree of particularity, it is understood that this disclosure has been made only by way of example and that the invention is not limited to the features of the embodiments described and illustrated herein, but includes all modifications and alterations falling within the scope and spirit of the invention as hereinafter claimed.

Claims (21)

1. An expandable in-ear device for implantation in the ear canal of a human and customized in-situ to fit the shape of the ear canal of a user using a settable compound, the in-ear device comprising:

a core member formed with a protruding portion that can be inserted into an ear canal;

a first sound hole extending from an ear canal outer position to an ear canal inner position through the protruding portion for transmitting sound therein; and

a deformable covering extending integrally from the core, the deformable covering being deformable between an expanded configuration and a collapsed configuration of the in-ear device, wherein when the covering is in the expanded configuration the covering extends away from the protruding portion while remaining attached to the core, the covering being foldable from the expanded configuration to the collapsed configuration in an inside-out manner, wherein the covering is in an overlapping relationship with respect to the core so as to cover the protruding portion while defining a space between the covering and the core, the space being fillable with a settable compound.

2. The device of claim 1, wherein the core-shaped member further defines a platform portion defining a platform distal end and a platform proximal end opposite the platform distal end, the projection extending from the platform proximal end, the projection defining a projection distal end adjacent the platform proximal end and a projection proximal end opposite the projection distal end;

the sheath integrally extends from the location of the proximal end of the projection when the in-ear device is in the expanded configuration and the sheath is in overlapping relation with respect to the core member to cover the projection portion and the platform portion when the in-ear device is in the collapsed configuration, the sheath defining an aperture therethrough that overlies the distal end of the platform when the in-ear device is in the collapsed configuration.

3. The device of claim 2, wherein the platform distal end has a platform distal end perimeter defining a raised platform projection surface, the bore of the sheath having a shape that presents a perimeter of the platform projection surface.

4. The device of claim 2 wherein said first soundhole extends from a location within the ear canal proximal to said protrusion to a location outside the ear canal distal to said platform.

5. The device of claim 1, wherein said sheath tightly covers said core and said compartment is free of fluid when said in-ear device is in said collapsed configuration.

6. The device of claim 1, wherein the in-ear device is a one-piece molded component.

7. The device of claim 3, wherein the bore of the sheath has a perimeter reinforced by a lip extending integrally from the sheath to mate with a corresponding groove on the perimeter of the raised surface of the platform distal to the platform to seal the gap.

8. The device of claim 2, wherein said platform portion includes a cavity extending inwardly from a location adjacent said platform distal end, the in-ear device further comprising an insertion member releasably mated with said cavity of said platform portion; and a second acoustic port extending from a location proximal to said protrusion through said protrusion and said platform portion to said cavity of said platform portion for transmitting sound therein.

9. The device of claim 8, wherein the insert member is a plug member to seal the second acoustic port, whereby the in-ear device is an earplug member.

10. The device of claim 8 wherein said insert includes communication means for communicating sound with said second sound hole.

11. The device of claim 10 wherein the communication component is a band pass filter for passing an acceptable frequency range into the ear canal, whereby the in-ear device is a filtering earplug device.

12. The device of claim 10, wherein the communication component is a second chamber extending inwardly into the insertion component for releasable engagement with an electronic circuit component that amplifies sound in a predetermined frequency range and transmits it from outside the ear canal to the second sound hole, whereby the in-ear device is configured as a hearing aid device.

13. The device of claim 10, wherein the communication member is a sound hole extension through the insert member, the sound hole extension communicating with the second sound hole at its proximal end and adapted to engage with an external hearing aid device at its distal end, whereby the in-the-ear device is a hearing aid fitting device.

14. The apparatus of claim 2, wherein the distal end of the first soundhole is located within a platform protrusion surface of the platform portion and is closed and stopped by the elongated membrane as long as a remote device is not inserted therein.

15. The apparatus of claim 10, further comprising a handle member secured at a location distal to the platform.

16. The device of claim 15, wherein said handle member is bonded to said platform portion of said core member.

17. The device of claim 15, wherein said handle member includes teeth for engaging corresponding recesses on said platform portion for properly positioning said handle member relative to said core member, said handle member having a bore extending longitudinally therethrough for guiding an injection device containing a settable compound into a slot-like slot in said platform portion, said slot-like slot communicating with said space for allowing settable compound to flow from said slot-like slot into said space.

18. The device of claim 17 wherein said opening in said handle member is sealed by a membrane in contact with said core member.

19. A device according to claim 17, wherein said slit-like slot is automatically closed upon withdrawal of the injection device therefrom.

20. The device of claim 2, wherein the distal end of the platform is formed with a convex shape having an extended apex and being symmetrical thereto, the convex shape forming two planar surfaces with the extended apex forming a common distal edge therebetween, the planar surfaces extending away from each other from the common distal edge and toward the proximal end of the platform.

21. The device of claim 20, wherein one of the two surfaces has a platform distal perimeter defining a protruding platform protrusion surface, the sleeve aperture having a shape that assumes the perimeter of the platform protrusion surface, the other of the two surfaces being completely covered by the sleeve and customized in situ to the shape of a human ear chamber corresponding to an ear canal when in a folded configuration.