Patent Description:
This section also provides a general summary of the disclosure, and is not a comprehensive disclosure of its full scope or all of its features.

It is well known that children can be born with ear malformations, which can often be the result of genetics, viral infections, and/or lack of blood supply or toxins during pregnancy. It is estimated that <NUM>-<NUM>% of children are born with some form of congenital ear defect. There are various forms of ear malformation that include microtia (underdeveloped ear), anotia (missing an ear), protruding ears (ears that stick out more than <NUM>), Stahl's ear (pointed shape), cryptotia (cartilage buried beneath the skin), and ear tags (accessory cartilage). Some malformations can also have effect on proper vision in children, as a child with an improperly formed ear cannot wear glasses. For children with ear deformities or malformations, there is dramatic psychosocial harm done to the child most often due to severe teasing and bullying.

Ear deformities are traditionally treated in two ways: surgery for ear reconstruction and ear molding on newborns. Surgery is often costly, and the risks of anesthesia and other complications usually defer surgery until the child reaches at least six to ten years of age. Unfortunately, surgical solutions after lead to outcomes that lack in both appearance and functionality.

Therefore, if it is possible, ear modeling is preferred over surgical solutions. It is understood that an infant's ear is malleable in the first several weeks of life and, thus, deformities can potentially be corrected before surgical intervention is needed.

Ear molding in newborns can only be done with outer ear deformities where none of the ear is missing but is just misshaped. Currently, the most commonly-used molding technique is a mold <NUM>, known as the EARWELL as illustrated in <FIG>. As can be seen from the figures, the mold is a large device that covers the entire ear and surrounding area. Adhesive tape is typically used to retain the mold in position on the infant patient. It is also noted that a large area of shaving is required to allow for copious adhesive necessary to maintain the device in place. Unfortunately, the device, due to its size and attachment method (i.e. adhesive), is susceptible to dislodgement and other complications. Highly complex base and inserts prevents the possibility for replacement by the patient family. The entire device is excessively large, poorly tolerated, and may be prone to displacement.

From <CIT> an ear splint according to the preamble of claim <NUM> is known. This ear splint, however, uses adhesive surfaces for securing the central portion and the wing portion to the ear, which is regarded detrimental.

In view of this it is an object of the invention to provide an efficient and well tolerated ear splint.

This object is solved by an ear splint according to claim <NUM>.

According to the principles of the present teachings, an ear splint to correct congenital ear deformities is provided that is both low-profile and comfortable. In some embodiments, the ear splint of the present teachings is particularly suitable for use on malleable infant ears. Ideally, the ear splint can be manufactured using a 3D printing technique to ensure proper configuration, comfort, and patient-specific fitment. This results in a patient-specific ear splint that is rapidly produced, at low-cost, and that avoids the need for skin adhesive that can lead to complications and skin breakdown.

Furthermore, according to the principles of the present teachings, an ear splint for an ear is provided having a central portion having an exterior surface defining a first topology that is configured to dwell within an anterior scaphoid section of an ear, and a wing portion extending from the central portion and integrally formed therewith and at least partially surrounding an outer periphery of the central portion. The wing portion includes an exterior surface defining a second topology and is configured to be positioned along a postauricular area of the ear. The first magnetic device is disposed in the central portion and the second magnetic device is disposed in the wing portion. The magnetic retention feature exert a magnetic attractive force between the central portion and the wing portion such that at least a portion of the exterior surface of the central portion and at least a portion of the exterior surface of the wing portion contact the ear.

As described herein, ear malformations exist on a spectrum from slightly noticeable asymmetry and deformity to complete absence of the ear. When the cartilaginous component of the ear is partially or completely missing the current gold standard is use of costal cartilage for reconstruction. Malformations seen when the cartilage is present, but deformed, including cup ear deformity, Stahl ear deformity, prominotia, and low-grade microtia, are often unaddressed. This may be due to paucity of available treatment options. Additionally, the patient and caregiver may decide surgical intervention and associated risks do not outweigh the benefits of restoring normal shape to the ear.

The use of ear splints to conservatively correct selected ear malformations without surgery, secondary to malleability of the infant ear cartilage, has been described with reports of success. However, the current devices on the market are highly expensive, cumbersome for the family and surgeon to use, and questionably tolerated by the patient. The most established device, the EarWell (see <FIG>), costs approximately $<NUM>,<NUM> per ear, necessitates a physidan to remove and replace in situations of skin breakdown and splint displacement, and is extremely bulky.

According to the principles of the present disclosure, an ear splint is provided that is capable of overcoming the disadvantages of the prior art. In some embodiments, the present teachings provide an ear splint can comprise a three-dimensional (3D) structure that is based on three-dimensional scanning and, in some embodiments, printing modalities that result in an extremely cost-effective, easy to use, and more aesthetically pleasing ear splint device for ear malformations and other uses.

In some embodiments, an ear splint <NUM> is provided having a central portion <NUM> and a wing portion <NUM> generally surrounding the central portion <NUM>. It should be understood that the particular size and shape of ear splint <NUM> can vary depending on the associated size and shape of the ear of the patient, therefore the description and figures should not be regarded as limiting unless otherwise claimed. In some embodiments, central portion <NUM> is sized and shaped to be inserted within the concha and/or scaphoid portion of the ear. Likewise, in some embodiments, wing portion <NUM> is sized and shaped to surround central portion <NUM> and extend about an exterior portion of the ear, such as along the post auricular and anterior scaphoid area. In this way, wing portion <NUM> can be opposingly-spaced relative to central portion <NUM>.

It should be appreciated that, in some embodiments, an exterior surface <NUM> of central portion <NUM> defines a shape that is substantially similar to a desired internal, post-formation topology of the ear. Likewise, in some embodiments, an exterior surface <NUM> of the wing portion <NUM> defines a shape that is substantially similar to a desired external, post-formation topology of the ear. In some embodiments, the shape of central portion <NUM> and wing portion <NUM> is determined by a clinician prior to treatment, is a mirror shape of the scanned shape of a patient's properly formed ear, and/or is selected from a library or database of potential ear shapes. To this end, each of central portion <NUM> and wing portion <NUM> can define a contour having a complex, multi-surface and/or multi-faceted shape, as illustrated in the figures, that is similar to a final or incremental topological shape of the ear. More particularly, in unilateral ear deformities, a multipod photographic scan, laser scan, or DICOM base imaging scan can be used to obtain topologic data from the normal ear, then mirror and serve as a template for the patient specific ear splint. In the case of bilateral ear deformity, normative data could be used or computer aided virtual repair of ear deformities could allow for template production.

In some embodiments, ear splint <NUM> can be sized and shaped to be generally positioned within the ear and generally surround the ear such that ear splint <NUM> does not extend beyond the helix or other outermost elevational portion of the ear. In some embodiments, ear splint <NUM> is made of a material, such as soft silicone material, that is likely to minimize pressure necrosis.

In some embodiments, ear splint <NUM> can comprise one or more magnetic retention features <NUM>. In some embodiments, magnetic retention features <NUM> can comprise opposingly-spaced magnetically attracting pairs of magnets <NUM>, <NUM>. More particularly, as illustrated in <FIG> and <FIG>, ear splint <NUM> can comprise a first pair of magnets 30A-32A, a second pair of magnets 30B-32B, and an n-th pair of magnets 30n-32n radially disposed in central portion <NUM> and wing portion <NUM>. Magnetic retention features <NUM> are configured to exert a magnetic coupling force between central portion <NUM> and wing portion <NUM> to provide a force sufficient to grasp and urge the malleable cartilage of the ear to form into a shape that is substantially similar to the exterior surface of the central portion <NUM> and the wing portion <NUM>. Magnets <NUM>, <NUM> can be disposed in bores <NUM> formed in central portion <NUM> and wing portion <NUM> or otherwise coupled thereto, such as through adhesive, fastening, overmolding, and the like. However, as illustrated in <FIG>, in some embodiments, magnetic retention feature <NUM> can comprise a single pair of magnets <NUM>, <NUM> that extend along a circumferential portion of central portion <NUM> and wing portion <NUM> in opposing relation to each other.

The opposingly-spaced arrangement of magnetic retention features <NUM> (and, specifically, magnets <NUM>, <NUM>) serves to aid in the precise alignment of central portion <NUM> and wing portion <NUM> to define an ear molding volume between central portion <NUM> and wing portion <NUM>. Exterior surface <NUM> of central portion <NUM> and exterior surface <NUM> of wing portion <NUM> together define the ear molding volume that will serve to shape the malleable cartilage of the ear through exertion of formation pressure thereon. By securing the device with the multi magnet design, the need for skin adhesive/glue is mitigated and/or eliminated. Furthermore, by preventing the need for adhesive there is no need for shaving. This arrangement further minimizes and/or eliminates skin breakdown and wound issues, and provides improved overall patient and family experience.

Minimization of skin irritation is further achieved by the precise placement of a silicone housing for magnets <NUM>, <NUM>. Magnets <NUM>, <NUM> can be inset within bore <NUM> to prevent direct contact of the magnet with the skin, thereby permitting on the soft silicone material of central portion <NUM> and wing portion <NUM> to touch the skin of the patient. Moreover, by distributing the force generated by the magnetic pressure of magnets <NUM>, <NUM> to all of central portion <NUM> and wing portion <NUM>, adequate cartilage shaping support is imparted while avoiding risk of pressure necrosis. The magnetic distribution can be tailored to the deformity and would range from <NUM> par to <NUM> pair, generally.

In some embodiments, a distal end portion <NUM> of wing portion <NUM> comprises one or more magnetic securement features <NUM>. In some embodiments, magnetic securement feature <NUM> can comprise one or more opposingly-spaced magnetically attracting securement pairs <NUM>, <NUM>. Magnetic securement feature <NUM> can be used to retain and/or secure ear splint <NUM> in engagement with the patient's ear. To this end, in some embodiments as illustrated, magnetic securement feature <NUM> can comprise magnet 44A disposed in a proximal portion <NUM> of wing portion <NUM> generally adjacent where wing portion <NUM> extends from central portion <NUM>. One or more magnets 46A-n can be disposed along distal end portion <NUM> of wing portion <NUM> such that magnet 44A and magnet 46A-n are magnetically joinable. It should be understood that any one of magnets 46A-n can be magnetically joined to magnet 44A to permit adjustment of ear splint <NUM> on the patient. This adjustment can permit continued use of ear splint <NUM> as the ear and/or patient grows. It should be understood one or more magnets 44A can be used with one or more magnets 46A-n to permit a greater degree of adjustment.

In some embodiments, the overall design is configured to permit ear splint <NUM> to be positioned within the ear structures and in the post auricular crease behind the ear allowing for extremely low profile. Moreover, the simplicity of insertion of central portion <NUM> and wing portion <NUM>, together with the simple attachment of magnetic retention features <NUM> and magnetic securement features <NUM>, enable a parent or lay caregiver the ability to reattach ear splint <NUM>. Ear splint <NUM>, due to its personalize shape and low-profile design, minimize displacement while maximizing comfort to the patient. The design allows for extremely low profile noting it does not project beyond the native ear. The paired magnet design allows for precise placement, even by the novice. This additionally makes removal of the splint in several potential scenarios - parent desire for specific events, MRI, bathing - simple to perform and replace.

In some non-limiting embodiments, ear splint <NUM> can comprise <NUM> lbs (<NUM> N) magnets, although potential magnet strengths ranging from <NUM> N to <NUM> N are within the scope of the present teachings. This strength diminishes as the soft tissue distance increases. In some embodiments, ear splint <NUM> defines a surface area upon which force is applied to be <NUM>^<NUM>, which would vary based on the patient size. In an exemplary embodiment employing <NUM> pairs of magnets, the pressure exerted is less than <NUM> Pascals or <NUM> psi from the magnets.

Ear splint <NUM> can be manufactured accordingly to any convenient method, such as 3D-printing, molding, and the like. It is preferable that ear splint <NUM> is made for a particular patient and/or application. However, it should be understood that many of the principles of the present teachings are applicable to mass production. Moreover, ear splint <NUM> can be made using a personalized mold <NUM>, as illustrated in <FIG>. The mold <NUM> can include unique design components to enable rapid, precise manufacturing. For example, the strategically-placed pour access <NUM> maximizes filling of the central portion <NUM> of the ear splint <NUM>, which requires the highest volume of silicone or other material. Adjacent air vents <NUM> in the mold <NUM> allow effusion of air bubbles during the curing process. The elevated sides <NUM> snap the mold <NUM> into place to prevent silicone leakage during curing. The three-part design allows for easy disassembly of the ear mold, particularly in the narrow magnet wells.

Although the present teachings are particularly adapted and configured for use as an ear splint to aid in the proper development of malformed ears in infants, it should be understood that varying and useful embodiments and methods of use are envisioned. By way of non-limiting example, ear splint <NUM> can be used as a post-operative dressing for ear surgeries. One of the most common complications of ear surgeries is post-operative hematoma. The secure fit and pressure provided by the design of the magnetic ear splint may eliminate the risk of hematoma and may also improve postoperative appearance. Silicone is known to decrease scarring, hypertrophic wound healing, and keloiding.

In some embodiments, it should be understood that ear splint <NUM> can be used for alternative uses, such as, but not limited to, a customized earplug or headset design for any user. In such embodiments, it should be understood that the topology of central portion <NUM> and wing portion <NUM> need not define a desired post-procedure topology, but rather may merely represent a custom fit of the current ear topology without intending to manipulate or otherwise treat the ear. Instead, ear splint <NUM> can define a customized topology that closely (if not exactly) contours to the existing ear topology. This can be particular useful in application that require a comfortable, sealing connection to the ear, such as, but not limited to, swimming and watersport uses, firearms applications, aviation application, or other applications where uses traditionally need sealing and/or hearing protection. Still further, as illustrated in <FIG> and <FIG>, ear splint <NUM> can comprise a bone conduction-type hearing aid <NUM> (<FIG>) and/or a Bluetooth type wireless transmitting system <NUM> (<FIG>). To this end, ear splint <NUM> may serve as a platform and housing for Bluetooth receiver and speaker. Similarly, in bone conduction applications, optimal deliver of the bone conduction may include the central portion <NUM> or the wing portion <NUM>.

With the intended high level of ear feature specificity, circumferential ear design, and magnetic securement, fit is intended to be highly secure and comfortable. This design facilitates maintenance of placement making the device well suited for exercise and activity.

Claim 1:
An ear splint for an ear, the ear splint (<NUM>) comprising:
a central portion (<NUM>) having an exterior surface (<NUM>) defining a first topology, the central portion (<NUM>) configured to dwell within an anterior scaphoid section of an ear; and
a wing portion (<NUM>) extending from the central portion (<NUM>), the wing portion (<NUM>) being configured to be positioned along a postauricular area of the ear;
characterized in that the central portion (<NUM>) is integrally formed with the wing portion (<NUM>) which at least partially surrounds an outer periphery of the central portion (<NUM>), the wing portion (<NUM>) having an exterior surface (<NUM>) defining a second topology, the wing portion (<NUM>) configured to be positioned along a postauricular area of the ear; and
a magnetic retention feature (<NUM>) having a first magnetic device (<NUM>) and a second magnetic device (<NUM>) being magnetically attractive to each other, the first magnetic device (<NUM>) being disposed in the central portion (<NUM>), the second magnetic device (<NUM>) being disposed in the wing portion (<NUM>), the magnetic retention feature exerting a magnetic attractive force between the central portion (<NUM>) and the wing portion (<NUM>) such that at least a portion of the exterior surface (<NUM>) of the central portion (<NUM>) and at least a portion of the exterior surface (<NUM>) of the wing portion (<NUM>) contact the ear.