Oto-block applicator and method

An oto-block applicator, includes a plunger, an oto-block holder configured to couple to the plunger; and an insertion stop coupled to said oto-block holder, wherein the insertion stop is configured to prevent insertion of the oto-block holder past a predetermined distance into the ear, and the plunger is configured to push an oto-block held within the oto-block holder out of a front end of the oto-block holder and into the user's ear.

BACKGROUND

The embodiments herein relate generally to devices and methods for making customized ear products, and more specifically to methods of creating an accurate impression of the ear canal using molded impressions.

Producing customized ear products requires obtaining an accurate impression of the ear canal. Due to the curvature of the ear, this may be challenging, particularly for the untrained consumer. Certain digital methods may employ cameras and/or scanning devices on consumer electronics for obtaining an ear canal impression. Such methods may be limited in the device's ability to ‘see’ far enough past the first bend of the ear canal to obtain accurate data.

Other methods may entail obtaining a mold impression of the ear by inserting or stuffing an impression material into the ear canal. This may typically involve first inserting an oto-block into the ear canal in order to protect the ear drum from the impression material. However, inserting the oto-block and hence the impression material deeply enough to obtain an accurate impression may be challenging as well.

As such, there is a need for an improved system for creating accurate ear impressions, and particularly for such systems which may be employed used by both professional and unprofessional users.

SUMMARY

According to various embodiments, disclosed is a system for creating an impression of an ear canal, comprising an applicator and an applicator method for safely inserting an oto-block into the ear canal. The disclosed system enables an untrained user to safely take an accurate ear impression that may reach past the first bend of the ear canal. As such, consumers may take ear impressions at home to use for ordering various products that require an ear mold through the mail or online.

In embodiments, the disclosed applicator has a stopper disc, and plunger release mechanism that is configured to insert the oto-block to a predetermined depth, and ensure it reaches a proper and safe distance into the ear canal, for creating a reliable custom ear product. Additionally, the disclosed system uses a vented oto-block which prevents pressure build up when stuffing the impression material.

DETAILED DESCRIPTION OF CERTAIN EMBODIMENTS

Creating an accurate impression of the ear canal may be a critical element in producing custom ear products such as ear molds, ear plugs, ear buds, ear phone IEM adapters, hearing aids, etc. The disclosed subject matter provides a system that enables either trained or untrained users to safely take an accurate impression of the ear canal. As such, the untrained user may create an impression at home for use in ordering various products through the mail or Internet, without having to visit a professional such as an audiologist.

According to certain embodiments as depicted in the figures, the disclosed system provides an oto-block applicator configured to safely insert an oto-block26into the canal of a human ear42. In embodiments, oto-block26may have a cylindrical body made of a material such as foam, and may comprise a pull element28for enabling the oto-block to be pulled out of the ear canal. In further embodiments, oto-block26may be vented for preventing pressure build up, i.e. permitting pressure release, when stuffing the impression material into the ear canal. In some embodiments, pull element28may be a vent tube which may provide the oto-block with its venting functionality (as well as enabling it to be pulled out of the ear). Pull element28(“vented pull element28”) may comprise for example, a flexible silicone vent tube that acts similar to a thread (such as used in standard oto-blocks), and may be attached through the center26aof the oto-block. It should be appreciated that the disclosed subject matter may be used with various types of oto-blocks, including non-vented oto-blocks, which may comprise a standard non-vented thread (e.g. cotton thread or the like).

In certain embodiments as best depicted inFIGS.1-5C, the oto-block applicator may comprise an applicator body10, a plunger11, and oto-block holder13. Applicator body10may include a top portion10aconfigured to retain plunger11and oto-block holder13, and a bottom portion10bwhich may serve as a handle for the applicator. In certain embodiments, top portion10aof applicator body10may comprise a plunger cavity10cwithin a back side of top portion10a. The plunger cavity may be configured to slidably receive and/or retain plunger11.

Plunger11may be configured to push oto-block26out of oto-block holder13. In embodiments, plunger11may comprise a plunger stem14coupled to a plunger base12as best depicted inFIGS.3-4B. In some embodiments, plunger stem14may include a stem aperture14aconfigured to permit vented pull element28to pass therethrough. In some embodiments, the plunger may be pre-assembled with applicator body12. As depicted in the figures, cavity10c/plunger base12may comprise corresponding tubular/cylindrical configurations according to certain embodiments. It should be appreciated however, that other geometric shapes may be employed without departing from the inventive concept.

As best depicted inFIGS.4Aand B, a spring15may be positioned between a front wall17of cavity10cand plunger base12to provide push back tension on plunger11. As such, the spring is configured to push the plunger back to its original position, enabling its reuse; and may further assist in helping a user control the release speed of the oto-block. It should be appreciated that an alternate elastic element, such as a band, may replace the spring according to various embodiments.

In certain embodiments, top portion10aof applicator body10may further comprise an applicator connector19configured to connect oto-block holder13to applicator body10. In embodiments, applicator connector19may generally be positioned opposite plunger cavity10c, on a front side of top portion10a. Additionally, an applicator aperture21may run through connector19to plunger cavity10c, for permitting plunger stem14to pass therethrough.

In certain embodiments as best depicted inFIG.2, oto-block holder13may comprise a nozzle fitting16and an applicator tip23. Nozzle fitting16may comprise a back portion16aconfigured to connect to applicator connector19. Nozzle fitting16may further comprise a front portion16bconfigured to connect or bond to applicator tip23. Additionally, nozzle fitting16may include a fitting aperture16c, permitting plunger stem14to pass therethrough. In embodiments, applicator tip23may have a tubular configuration and may be jacketed over front portion16bof the nozzle fitting. According to various embodiments, nozzle fitting16and applicator tip23may be permanently attached. According to an exemplary embodiment, nozzle fitting16may be formed from a hard material, such as plastic, and the like, while applicator tip23may be formed from a flexible/stretchy material, such as silicone, rubber, foam, etc. Additionally, nozzle fitting16may comprise rings or barbs, as shown, wherein applicator tip23may be stretched or pressure fit over nozzle fitting16. In some other embodiments, an adhesive may be used to bond the components together. It should be appreciated that various materials, geometric configurations, attachment mechanisms etc., may be employed without departing from the inventive concept.

In embodiments, back portion16aof nozzle fitting16is configured to lockably engage and disengage from connector19. For example, as depicted in the figures, the back portion of nozzle fitting16may be cylindrically shaped and include a locking tab18while connector19may include a cylindrical hollow comprising a locking tab receiver20, whereupon nozzle fitting16may be inserted into connector19and twisted in a first direction to lockably engage the locking tab18within tab receiver20. Twisting nozzle fitting in a second direction, opposite the first, may thereafter disengage the components. It should be appreciated that other mechanisms for fastening nozzle fitting16to connector19may be employed, e.g. a threaded connection, without departing from the inventive concept.

In certain embodiments, applicator tip23may comprise a tip nozzle24, configured to hold oto-block26, wherein oto-block26may be pushed out of the front end of the tip nozzle24(or front end of the oto-block holder) via plunger stem14(seeFIG.4B). As shown in the figures, and in accordance with an exemplary embodiment, tip nozzle24may be a stretchy and/or flexible tubular member having an internal diameter conforming to the external diameter of oto-block26, to provide a snug and/or compressed hold of the oto-block. The plunger stem14may then break that hold when pushed against the oto-block, releasing it from the tip nozzle24.

Applicator tip23may further comprise an insertion stop element22(or flange22) configured to guide insertion of the oto-block to a proper and safe distance. Flange22may be shaped, for example, as a disc as shown in the figures; however other geometric shapes may be employed.

In its assembled state as best depicted inFIGS.1,4Aand B, and5C, at least a portion of plunger base12may slidably reside within plunger cavity10c, and oto-block holder13may be connected to applicator connector19of applicator body10. Plunger stem14may extend through apertures21and16c, which may be centrally aligned, and oto-block26may be held within tip nozzle24of oto-block holder13. Vented pull element28may further pass-through stem aperture14a. In this state, plunger11may be used to push the oto-block out of the holder by pushing plunger base12forward, whereby oto-block26is pushed forward by plunger stem14to release it into the ear canal.

According to an exemplary embodiment, to keep the applicator at a safe distance for insertion of the oto-block, and/or to prevent the oto-block from inserting too deeply into the canal, flange22may be positioned at a distance ‘d1’ of approximately 25 mm from the end of tip nozzle24(seeFIG.4A). Additionally plunger stem14may extend a distance ‘d2’ of approximately 1 mm from the tip nozzle24in the fully forward/fully compressed state of the spring (seeFIG.4B).

According to certain embodiments as best depicted inFIGS.5A-9, once the oto-block applicator is assembled and loaded with the oto-block, it may be used to insert the oto-block into an ear canal. After insertion of the oto-block, impression material may be stuffed into the ear and allowed to harden in order to form the ear canal impression.

According to an exemplary embodiment, a user may be provided with an impression taking kit as depicted inFIG.2, which may comprise a plurality of oto-block holders26, which may each contain a pre-inserted oto-block26. The kit may further comprise an applicator body10, which may be pre-assembled with plunger11. The kit may also include impression material30, which may be provided in a quantity sufficient to create multiple impressions. In embodiments, the impression material30may comprise a first premix component32and a second premix component34, which may be mixed to create an activated impression material36that is ready for use. The impression material may be, for example, a silicone-based material such as Otoform™, wherein first and second premix components32,34, may be pastes, that when mixed together, form activated impression material36which is a putty that is catalyzed for hardening.

In embodiments, the impression taking kit may be used for creating an ear canal impression by first attaching oto-block holder13to the applicator body10as depicted inFIGS.5A-C. This process may comprise inserting vented pull element28into stem aperture14aof plunger stem14(seeFIG.5A). Nozzle fitting16may then be slid over plunger stem14, to insert stem14into fitting aperture16c(seeFIG.5B). Nozzle fitting16may thereafter be inserted and locked to applicator connector19by twisting locking tab18of the nozzle fitting into locking tab receiver20of applicator body10(seeFIG.5C).

Once assembled, the applicator may be used to insert the oto-block into the ear canal, as depicted inFIGS.6A-D. This process may comprise first inserting the tip nozzle24containing oto-block26into the ear canal, as depicted inFIGS.6Aand B. In embodiments, this should be performed slowly, wherein the user may swivel the applicator to find the right insertion angle. Once the proper insertion angle is determined, the tip nozzle24may be further inserted until flange22contacts the outer ear (seeFIG.6B). The user may then press against plunger base12, whereby plunger stem14pushes against the oto-block to release it into the ear canal, wherein vented pull element28may dangle out of the ear (seeFIGS.6Cand D). In embodiments, the user may need to slowly push the plunger base12several times to release the oto-block from the applicator. Thereafter, the user may slowly remove applicator from the ear, being careful not to pull vented pull element28while doing so. As shown in the figures, the bottom portion10bof applicator body10provides a handle which enables the user to comfortably hold the applicator in his/her hand40, while using the thumb to press against the plunger base. Additionally, spring15forces the plunger base to its original position, enabling its reuse. The push back tension of the spring may further assist a user in controlling the release speed of the oto-block as it is inserted.

Once the oto-block26is inserted into the ear canal, the user may insert the impression material into the ear to form a hardened ear canal impression, as depicted inFIGS.7A-9. This process may comprise first mixing or kneading the first premix component32with the second premix component34to form the activated impression material36(seeFIGS.7Aand B). In embodiments, the premix components may be provided in different colors, wherein sufficient mixing may be indicated color uniformity of the resultant mixture. According to various embodiments, the kneading process may take about 10-20 seconds, or about 15 seconds or less. Additionally, as hardening of the activated impression material initiates upon mixing, the premix components should be kneaded immediately prior to inserting the material into the ear canal.

Once the components have been sufficiently mixed, the user may begin inserting or hand-stuffing the resultant impression material36into the ear canal as depicted inFIGS.8A-D. This may comprise first stuffing impression material36into the inner most depth (i.e. against the oto-block), and working out from there (seeFIGS.8Aand B). Stuffing of the impression material may be performed in a kneading fashion and with light to medium pressure to ensure filling of all the spaces and crevasses of the ear canal. In embodiments, the oto-block vent tube26amay help release pressure built up in the ear canal when the impression material is stuffed. This permits impression material to be properly stuffed and/or inserted to a sufficient depth. Once the ear is fully stuffed, the impression material is allowed to cure or harden. In embodiments, hardening may take about 5 to 10 minutes, or about 7 minutes, depending on factors such as type and/or condition of the impression material, user speed, ambient conditions, etc. In some embodiments, the user may press his/her finger against the impression material to determine proper curing. In some embodiments, a bite block38may be used while forming the impression, as shown inFIG.9. Once the impression material has fully hardened, the user may remove the formed impression from the ear, with the oto-block from the ear, as shown inFIG.8D. In some embodiments, the user may massage the ear love in a circular motion (seeFIG.8C) to loosen the material prior to removal.

The constituent elements of the disclosed device and system listed herein are intended to be exemplary only, and it is not intended that this list be used to limit the device of the present application to just these elements. Persons having ordinary skill in the art relevant to the present disclosure may understand there to be equivalent elements that may be substituted within the present disclosure without changing the essential function or operation of the device. Terms such as ‘approximate,’ ‘approximately,’ ‘about,’ etc., as used herein indicate a deviation of within +/−10%. Relationships between the various elements of the disclosed device as described herein are presented as illustrative examples only, and not intended to limit the scope or nature of the relationships between the various elements. Persons of ordinary skill in the art may appreciate that numerous design configurations may be possible to enjoy the functional benefits of the inventive systems. Thus, given the wide variety of configurations and arrangements of embodiments of the present invention the scope of the invention is reflected by the breadth of the claims below rather than narrowed by the embodiments described above.