Patent Publication Number: US-2013239301-A1

Title: Headgear Apparatus

Description:
BACKGROUND 
     People often need to wear headgear to secure devices to the face. Examples include sleep apnea devices—such as continuous positive airway pressure (“CPAP”) devices also referred to herein as nasal pillows—braces, retainers, glasses, and the like. Certain of such devices need to be secured to the face to resist forces which might otherwise remove the device in an undesired way or circumstance. For example, nasal pillows provide air under pressure to the nose and/or nostrils of a wearer while the wearer is sleeping. Nasal pillow headgear must counteract the forces produced by the air pressure and by movement of the wearer while sleeping. 
     Existing prior art headgear for securing nasal pillows to the head includes U.S. Pat. No. 7,225,811 and U.S. application Ser. No. 12/074,596, published as publication number 2008/0264422. The headgear disclosed in this prior art is undesirable because it is in contact with the user&#39;s hair, because it is in contact with much of a user&#39;s head, because it is claustrophobic, because it is visually disruptive, because it can be difficult to attach and remove, and because it produces physical and/or mental discomfort for users. Discomfort with prior art headgear prevents use of such headgear, notwithstanding that the device held on by the headgear may provide benefits to the potential wearer. 
     Needed is headgear for securing a nasal pillow or similar to the face, which headgear is more comfortable than the prior art. 
     SUMMARY OF THE INVENTION 
     Disclosed is headgear comprising at least an earbud and a strap suitable for attachment to a device, which device transports at least one of a gas, a liquid, and a solid suspended in a liquid to and/or away from the wearer. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a depiction of an embodiment on a human head. 
         FIG. 2  is a depiction of an embodiment not on a human head. 
         FIG. 3  depicts an embodiment, with and without various components. 
         FIG. 4  depicts an embodiment. 
         FIG. 5  depicts parts of embodiments. 
         FIG. 6  depicts an embodiment of attachment components. 
         FIG. 7  depicts an embodiment of attachment components. 
         FIG. 8  depicts embodiments of attachment components. 
         FIG. 9  depicts an embodiment of attachment components. 
         FIG. 10  depicts an embodiment of attachment components. 
         FIG. 11  depicts examples of angles found in the depicted drawing figures. 
         FIG. 12  depicts an embodiment including an air pump and memory, processing, and communications equipment. 
         FIG. 13  depicts an embodiment of attachment components. 
         FIG. 14  presents diagrams of ear components to illustrate vocabulary used herein. 
     
    
    
     DETAILED DESCRIPTION 
     The description of the drawings and following detailed description refer to the accompanying drawings. The reference numbers begin with a two-digit numeral which identifies the figure, followed by a three digit numeral which identifies the feature. The same feature number in different drawing figures generally identify the same or similar elements and/or components. A reference to a feature in an figure may be to “##ABC” where “ABC” is the feature number and “##” identifies any figure containing the feature. 
     The following detailed description is for the purpose of illustrating embodiments of the invention only, and other embodiments are possible without deviating from the spirit and scope of the invention, which is limited only by the appended claims. Certain of the figures are discussed in this specification using certain terms. The following discussion uses these terms and related terms as examples and not as limitations. The components depicted in certain of the figures represent functional groups; it should be understood that such functional groupings need not exist as discrete hardware devices and that the functions described as occurring within, comprising, or being provided by a grouping may be provided within or by common or separate physical devices. The functions within and comprising any of the function groupings may be regrouped in other combinations and certain of the components may be omitted or added without deviating from this disclosure. Certain of the groupings depict components which are included together in the illustration for the sake of convenience. Certain of the figures depict components in isolation; the components from different figures may be combined and/or regrouped. 
     The figures depict a human wearer; the wearer may be another animal with an ear canal and/or concha. 
     As used herein, a “provisioning system ## 011 ” is a device which transports at least one of (for example) a gas, a liquid, and a solid suspended in a liquid to and/or away from the wearer. Examples of such transported gas and/or material include pressurized air, food, water, oxygen, medicine, and/or anesthetic. A CPAP device or nasal pillow is a provisioning system. 
     Waveguides (discussed further below) may pass through, over, and/or be attached to the provisioning system ## 011 , the strap ## 005 / 009 , the earbud ## 001 , and the securing arm ## 003 , which waveguides may connect or connect to a sensor or emitter (such as a speaker inside an earbud or another sensor or emitter attached to or in proximity to the wearer) to equipment, which equipment, for example, may determine the state of a sensor and/or emitter and/or may provide the sensor and/or emitter with electrical power, digital data and/or analogue information and/or may connect the sensor and/or emitter with relays, computer memory, and/or computer processors, and/or a data sink or source. 
       FIG. 1  is a depiction of an embodiment on a human head. The embodiment comprises an earbud  01001 , a first portion of a strap  01005 , an optional cheek pad  01007 , and a second portion of the strap  01009 . The first and second strap portions may form one continuous portion. In use, the cheek pad  01007  may be located between the strap and the cheek of the wearer; the cheek pad  01007  may be connected to the strap; the connection between the cheek pad  01007  and the strap may be permanent, semi-permanent, or it may include a releasable connection and/or a friction device which allows the cheek pad  01007  to be moved or relocated along the strap or with respect to its position relative to the earbud  01001  and the provisioning system  01011 . Releasable connections and friction devices are discussed further below. The first  01005  and/or second portion of the strap  01009  may, for example, comprise a woven material, multi- or mono-filament string, webbing, ribbon, wire, bar of metal, natural or synthetic fibers, molded or extruded plastic, rubber, silicone, thermoplastic, vinyl, acrylic, fiberglass, carbon fiber, aramid or other composite. The strap  01005 / 009  and/or cheek pad  01007  may be and/or comprise a flexible and/or stretchable material. For the sake of simplicity of presentation, the strap  01005  is depicted as having a continuous connection with the earbud  01001 ; the strap may comprise an additional portion, such as a portion proximate or connected to the earbud  01001 , which is a rigid or flexible material and/or which comprises attachment hardware, such as a loop, bracket, or similar. 
     The provisioning system in the example depicted in  FIG. 1  is a nasal pillow  01011 , comprising a nostril cone  01015  and a conduit  01013 . In the example of a provisioning system which is a nasal pillow, the nasal pillow delivers pressurized air to the wearer. The conduit  01013  may transport at least one of a gas, a liquid, and solid suspended in a liquid to and/or away from the wearer. The provisioning system  01011  and/or the conduit  01013  may include one or more outlet ports (with or without a one-way valve) to exhaust exhaled gas from the user. The conduit  01013  may also include a waveguide (wire, fiber optic, etc.) to transport an electrical signal and/or data to and/or away from the wearer, which waveguide may also be part of or be attached to other components, such as the strap  01005 / 01009  and the earbuds  01001 . Waveguides may be incorporated into the components shown in  FIG. 1 . Waveguides may connect a component, such as a sensor or an emitter (such as a speaker inside an earbud) attached to or in proximity to the wearer, with electrical power, digital data and/or analogue information, relays, memory, and/or processors, and/or a data sink or source. Computer processing, memory, and wireless communication hardware and software may be located in one or more of the device&#39;s components and/or in the air pump  12115  or another component. 
     The provisioning system may comprise a device or component which covers the nose and/or mouth instead of as shown, with nostril cones  01015  inserted into the nostrils. As examples, the earbud ## 001 , securing arm ## 003 , strap ## 005 / 009 , cheek pad ## 007 , provisioning system ## 011 , and conduit ## 013  may be made of molded or extruded rubber, silicone, plastic, thermoplastic, vinyl, acrylic, fiberglass, carbon fiber, aramid or other composite, and/or one or more metals. 
     As used herein, a releasable connection is a connection between two or more components, which connection may be disengaged by a human without the use of a tool (examples of tools include screwdriver, pliers, drills, saws, welding machines, torches, and heat sources). A non-releasable connection is a connection between two or more components which connection may only be disengaged through use of a tool. 
     The illustration in  FIG. 1  also comprises an optional securing arm  01003 . The securing arm  01003  comprises, for example, at least a partial arc extending from the earbud, circumferentially posterior to the auricle (or pinna) of the wearer of the apparatus, to a region between the helix and the head of the wearer of the apparatus and behind the location where the first earbud is inserted into the conchal bowl and external auditory canal or ear canal of the wearer. Box  01002  in  FIG. 1  depicts an embodiment without the securing arm  01003 . Attachment of the securing arm  01003  to the earbud  01001  may be other than as shown in  FIG. 1  and other of the figures.  FIG. 11  depicts angles between the securing arm ## 003  and the earbud ## 001 , relative to the strap # 005  and relative to a vertical line  11117  drawn from the intersection of the securing arm  11003  and the strap  11005  (it being understood that the securing arm  11003  is also off-set toward the viewer in addition to being off-set approximately 25 degrees from the vertical line  11117 ). The angles shown in  FIG. 11  are based on angles using the particular model of a human head and ear found in the drawing figures, which model may not be accurate, average, or include all or even common features of heads and ears. The angular relationship of components in a particular implementation may vary significantly from those measured in  FIG. 11 . As noted above, the strap ## 005  and/or securing arm ## 003  may include an angled portion which travels in to the intersection of the strap ## 005  and/or securing arm ## 003  and/or the earbud ## 001 ; the depiction does not include such an angled portion because the particular model of the human head and ear used to prepare the figures did not require an angled portion, for example, to navigate the opening between tragus and anti-tragus (in the case of the strap ## 005 ) or to otherwise provide an off-set (outward, away from the head) between the strap ## 005  and the earbud ## 001 . 
     In use and as illustrated in  FIG. 1 , at least one earbud  01001  is in the ear of a wearer. The earbud(s)  01001  connect to the provisioning system  01011  via the strap, illustrated as having a first portion  01005  and a second portion  01009 . The earbuds  01001  and optional securing arm  01003  resist forces experienced and produced by the provisioning system  01011  and other components, transferring these forces to the concha, tragus, anti-tragus, external auditory meatus or ear canal, anti-helix, fossa triangularis, cymba and other ear components. The forces arise from, for example, positive air or gas pressure in the provisioning system, movement of the wearer, movement of the wearer and components relative to components attached to the provisioning system (such as an air pump), relative to a mattress, sheet, pillow, blankets, the wearer&#39;s clothing, gravitational forces on various of the components, and similar. The wearer may be asleep or awake, horizontal or vertical, while wearing the apparatus. The earbuds  01001  and optional securing arm  01003  may not resist all forces experienced during use, but may resist enough of such forces to secure the provisioning system to the wearer for a useful period of time. Embodiments and additional details of the apparatus are discussed further below. 
       FIG. 2  is a depiction of an embodiment not on a human head, provided for the sake of visual clarity. 
       FIG. 3  presents depictions of an embodiment and various components. Box  03004  in  FIG. 3  depicts an internal force transmitting component, referred to herein as the canal rod  03019 , which transmits forces to the ear canal and/or concha via portions of the earbud  03001  which extend into the ear canal and/or concha, which forces might otherwise remove the earbud from the ear. 
     The canal rod  03019  may be found inside of the earbud, for example, inside  03001 . The canal rod  03019  may be a different shape, for example to accommodate curvature and shrinking space within the ear canal. Box  03090  shows an example of a bent canal rod  03091 . The bend shown is an example; in practice curves may also be used, as well as more than one bend and/or curve. The amount of bend and/or curve may be variable across a distribution curve. In addition to and/or as part of custom made earbuds (discussed below), a characteristic bend and/or curve may be selected to accommodate a range of a target population, such as, for example, a quintile. 
     The canal rod  03019  may include a flange, notch or similar to accommodate and/or facilitate removal and re-attachment of earbud shells of different sizes from and to the canal rod  03019 . The canal rod  03019  may be a semi-flexible and/or deformable material, such as a metal, plastic, or thermoplastic, to allow it to be reshaped. The canal rod  03019  or an air tube(s) with a similar structure as depicted in  03019  may provided ventilation, auditory communication, connection with hearing aids, connection with removable securing arms  03003 , and similar. The force transmitting function of the canal rod  03019  may be provided by the rigidity of the material of the earbud, rather than being provided by a distinct canal rod component  03019 ; in this case, attachment of the strap  03005  to the earbud  03005  may be to a plate on the outer surface of the earbud, such as  11111  in  FIG. 11 , which plate then transfers the force to the earbud material. 
       FIG. 3  also depicts, in box  03008 , a schematic diagram of force transmitting components which come together in a junction in or proximate to the earbud. This schematic diagram illustrates that forces are transmitted up or from the strap  03005  and to the junction with the canal rod  03019 , and to the optional securing arm  03003  (a portion of each of such components being shown in box  03008 ). The strap  03005 , canal rod  03019 , and/or optional securing arm  03003  do not have to come together at a single junction, but may be mechanically connected via one or more other components, including through the material of the earbud. 
       FIG. 4  presents depictions of an embodiment including a brace  04021 . The brace  04021  in this illustration contacts the cymba or margin between the anti-helix and the concha of the ear, though the brace may contact other structures in the pinna. The brace  04021  may secure the earbud  04001  against rotational or other forces. The brace  04021  may be used in conjunction with the securing arm  04003 , shown in boxes  04010  and  04012 , not shown in box  04014 . 
       FIG. 5  depicts parts of embodiments. Box  05016  is meant to depict a molded earbud  05020 , molded to conform to the ear canal of a particular individual. The size and shape of the ear canal varies among individuals. The ear canal is a void with a generally sigmoid form and oval cross-section. Custom-molded earbuds have a corresponding positive form. Molded earbuds may also include one or more external portion(s) molded to the contours of an individual&#39;s concha, anti-helix, tragus, anti-tragus, and other pinna structures. Examples of custom-molded earbuds are shown in boxes  05028 ,  05030 , and  05032 . In the fabrication of custom-made earbuds, a bare canal rod may be inserted into the ear canal, following which silicone, wax, foaming and/or solidifying polymers, or another material or materials may be injected, poured, inserted, inflated, or otherwise situated in the ear canal around or through the inserted canal rod. The canal rod may comprise a disk, piece of foam, or similar on the end inserted furthest into the ear canal (hereinafter called a “retainer”), which retainer may retain the inserted material and reduce the rate at which the inserted material propagates past the retainer. The inserted material may harden in the ear canal or it may flow slowly enough that the inserted material may be removed, such as by pulling on the canal rod, whereupon the removed material may retain a positive form of the shape of the interior of ear canal for a period of time. The removed material may be hardened internally or externally to the ear canal (such as through application of ultraviolet light, application or activation of a hardening catalyst, application of heat or cold, or similar) and/or the removed material may be used to create a mold, which mold may be used to cast a form with the positive structure of the ear canal, which cast form may be cast around a canal rod. 
     To be used as part of the apparatus disclosed herein, the earbuds shown in boxes  05028 ,  05030 , and  05032  would need to be made of a sufficiently rigid material to resist forces which might otherwise remove the earbuds (rigidity of the material transferring the forces into the concha and/or ear canal), they would need a strap to connect the earbud to a provisioning system, and, optionally, they would include a securing arm  05003 . To accommodate a strap and (optional) securing arm, the earbuds shown in boxes  05028 ,  05030 , and  05032  need i) a connector to connect the strap to the earbud, the strap exiting the earbud, for example, in the notch between the tragus and anti-tragus, and ii) a(n) (optional) securing arm exiting the concha generally above the tragus. 
       FIG. 5  also presents in box  05018  a detail view of an assembly comprising a canal rod  05019  with discs  05022 . Discs  05022  may, as illustrated, be of graduated size, and may be made of a flexible material, selected to allow the assembly  05018  to be inserted into the ear canal (small disc first), to hold the assembly within the ear, and to allow the assembly  05018  to be removed from the ear canal with minimal discomfort. 
       FIG. 6  presents a depiction of an embodiment of attachment components. In this embodiment, which should be understood as an example, the strap comprises portion  06029  which comes from the earbud and/or the cheek pad  06025 , passes through an opening in the provisioning system  06011 , which opening may be located in a bracket  06031 , and then returns as portion  06027  to the cheek pad  06025 . At the cheek pad  06025 , a tab  06023  comprises a hook-and-loop system (commonly known under the registered trademark “VELCRO”) or another attachment system (snaps, buttons, hooks, etc.), which may be used to releasably secure the strap portion  06027  to the cheek pad  06025 . In this embodiment, a wearer may adjust the tension or length of strap between the earbud and the provisioning system by removing the tab  06023  from the cheek pad  06025  and changing the attachment location of the tab  06023  and the cheek pad  06025 . 
     More than one attachment system may be used in a single embodiment. For example, an embodiment may include a snap, to allow a strap ## 005  to be released by disengaging the snap, and a velcro system as described with respect to  FIG. 6 , to change the effective length of the strap between the earbud and the provisioning system. 
       FIG. 7  illustrates embodiments of attachment components including a friction device which may be used to adjust the tension between the earbud and the provisioning system. In this illustration, which should be understood as an example of a friction device, a cinch plate  07033  comprises two openings  07039  and  07041 . The strap portion  07035  passes through opening  07039  in a first direction and then through opening  07041  in the opposite direction, terminating in strap portion  07037 . It would be understood that the strap may be passed through the openings  07039 / 07041  in patterns other than as shown in  FIG. 7 , such as in a pattern wherein the strap portion  07037  would pass below strap portion  07035  as it exits opening  07041 . It is possible to move the strap through the two openings, but only with application of enough force to overcome the friction experienced by the strap and/or only after loosening the strap in the openings. The bar separating the openings  07039 / 041  may be free to move back and forth in the bracket, which may facilitate developing friction on the strap  07035 / 037  when loaded with tension and releasing the strap from such friction when not loaded. 
     Instead of or in addition to being located proximate to the provisioning device (as shown in  FIGS. 6 and 7 ), one or more friction devices or other attachment components may be located proximate to the earbud and/or the cheek pad. As an example,  FIG. 10  depicts attachment hardware comprising an opening  10103  in the strap  10005 . In  FIG. 10 , the attachment hardware comprises the opening in the strap  10005  into which the remaining portion of the strap  10117  may enter. A sleeve, not shown, may contain the remaining portion of the strap  10117  within the opening  10103  in the strap. When slid down the strap  10005 , the compression ring  10101  compresses the sides of the opening  10103  onto the remaining portion of the strap  10117  and holds the remaining portion of the strap  10117  and the strap  10005  together. As depicted in  FIG. 10 , the remaining portion of the strap  10117  is within the opening  10103  in the strap; it would be understood that the remaining portion of the strap  10117  may surround the strap  10005  and that the compression ring  10101  may then hold the remaining portion of the strap  10117  on the strap  10005 . The compression ring may screw onto a threaded receptacle (not shown) and/or may be part of a spring-loaded bracket (not shown) which spring biases the compression ring toward the end of the strap  10005  and/or which biases the compression ring into a compressed position. The two strap portions  10005  and  10117  may interlock together along a length, releaseably attaching to one another, for example through use of a component similar to the example provided by compression ring  10101 , with varying degrees of overlap to change the overall length of the connection between the earbud ## 001  and the nasal pillow ## 011 . 
       FIG. 8  illustrates two additional examples of friction devices. One of these includes a cinch plate  08053  through which strap  08047  passes as it comes from the earbud and/or cheek pad. The strap  08047  passes through a first opening  08055 , which first opening has a release gap  08054  to allow both portions of the strap to be removed from the first opening  08055 . The strap  08049  then passes through a second opening  08057 , through a device opening  08051 , back through the second opening  08057 , and the first opening  08055 . The device opening  08051  may be proximate to or part of a provisioning system, an earbud, and/or a cheek pad. The second opening  08057  may comprise a second release gap (not shown). 
     The second friction device illustrated in  FIG. 8  is a spring-loaded cylinder  08063  inside of a housing  08065 . The spring-loaded cylinder  08063  and housing  08065  both have openings  08064  (only the opening is the housing  08065  is visible in this illustration). When depressed, the opening in the spring-loaded cylinder  08063  lines up with the opening in the housing, allowing the two portions of the strap  08067  and  08069  to pass through aligned openings, which allows the tension on the strap to be adjusted. When released, a spring in the spring-loaded cylinder  08063  displaces the cylinder upward (relative to the orientation of  FIG. 8 ), pinches the strap portions between the now non-aligned openings, prevents movement of the strap portions, and maintains the adjusted tension on the strap between the earbud and the provisioning system. Other spring-loaded pincers may be used. 
       FIG. 9  illustrates one additional friction device embodiment. In this embodiment, the strap  09073  comes from the earbud or cheek pad, passes through an opening  09074  in a provisioning system (or in a flange  09075  attached to a provisioning system), and through an opening in a retainer disk  09077 . Curved leaf springs  09079  contact the strap  09081  (or knobs, indentations, or other structures on a strap, not shown) and create friction which resists pulling of the strap back down through the opening  09074 . In the embodiment also shown in  FIG. 9 , the curved leaf springs  09083  overlap (such as through an interlocking comb pattern, not shown) or are bonded at their intersections and have an opening between them for the strap  09073 . In this embodiment, the curved leaf springs  09083  may, for example, be compressed toward retainer disk  09077  to open up the opening between them, to reduce friction on the strap, and allow the strap to be passed through the friction device. 
       FIG. 13  illustrates an earbud  13001  including a cuff  13117 , though which the strap  13005  may pass. This figure is meant to be an other example of a releasable connection which may be used on the earbud and/or the provisioning system (here shown on an earbud). The cuff  13117  may include a clasp (not shown) to be tightened around the strap  13005 . The strap  13005  may include one or more chocks (or similar), which chocks prevent the strap  13005  from being pulled toward the provisioning system (not shown) but which allow the strap to be slipped through the opening in the cuff  13117 ; if multiple such chocks are present on the strap  13005 , then the user may place the strap  13005  through the cuff at the chock which provides the desired length between the earbud and the provisioning system. The cuff  13117  and strap  13005  may thereby form a lock and key system. The cuff  13117  system in  FIG. 13  may be combined with the compression ring of  FIG. 10 . 
     Not all possible attachment components, friction devices, and similar are shown. The figures contain examples. Other components may be used which would provide a similar function. 
     The apparatus may produce less discomfort than prior art systems for securing nasal pillows to the head, thereby making it more likely for the apparatus to be worn and for the wearer to obtain the benefits offered by the provisioning system. The apparatus may offer additional benefits such as attenuation of external noise and the generation of auditory signals by or in the earbuds. In addition, data collection sensor(s) may be located in the device, including in the earbud, the strap, the provisioning system, and/or the air pump to measure, for example, temperature, pulse, blood pressure, blood oxygen level, or other vital statistics.