Moldable magnet system for auricular compression therapy

Abstract

A compression device for treating auricular hematoma at a triangular fossa region of an ear. The device includes an anterior compression assembly with an anterior housing having load-distributing geometry configured to span the triangular fossa region, defining at least one anterior cover. At least one anterior magnet with a first magnetic polarity orientation is disposed within the anterior cover. A thermally moldable compression body couples to the anterior housing, having an anatomical interface surface configured to conformably engage contours of the triangular fossa region, including deformable material. A posterior assembly positions on a posterior auricular surface opposite the anterior assembly, including a posterior housing, a posterior cover, and a posterior magnet with opposite magnetic polarity orientation, such that the magnets attract to apply compressive force across ear tissue therebetween.

Description

MOLDABLE MAGNET SYSTEM FOR AURICULAR COMPRESSION THERAPYCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims the benefit of priority to United States Provisional Patent Application Serial No. 63 / 764,407, filed February 27, 2025, the entirety of which is incorporated herein by reference.FIELD OF THE INVENTION

[0002] This application relates to medical devices used for treating auricular conditions, and more particularly, a moldable magnet system configured to apply therapeutic compression to the ear while conforming to the natural contours of the ear anatomy.BACKGROUND

[0003] Blunt force trauma to the external ear, particularly in contact sports can result in a subperichondrial collection of blood known as an auricular hematoma. When blood accumulates between the cartilage and the overlying perichondrium, the blood supply to the cartilage becomes disrupted. Without timely intervention to drain the collected blood and apply sustained pressure to the affected area, the cartilage may undergo necrosis and fibrocartilaginous overgrowth, resulting in permanent auricular deformity commonly referred to as cauliflower ear. Treatment approaches have evolved to address this condition through various compression mechanisms designed to eliminate the potential space between the perichondrium and cartilage where fluid may reaccumulate after initial drainage.

[0004] Current treatment options include sutured bolster systems and magnetic compression devices. Sutured bolster systems involve placing compressible dressings on both sides of the ear and securing them with sutures passed through the ear cartilage. While this approach can restore the ear to its pre-injury form, it presents several drawbacks including patient discomfort during application, risk of infection from the sutures remaining in place for extended periods, and the requirement for clinical visits to both apply and remove the pressure bolsters. Magnetic compression devices offer a non-invasive alternative by using opposing magnets placed on the front and back surfaces of the ear to apply pressure through magnetic attraction. However, existing magnetic products utilize rigid magnets with flat opposing surfaces that do not conform to thecomplex three-dimensional curvatures of the ear anatomy, resulting in non-uniform pressure distribution and failure to restore the ear to its natural pre-injury appearance.

[0005] Currently, there is a demand for an auricular hematoma treatment device that combines the non-invasive benefits of magnetic compression with the ability to conform to the natural contours of the ear. Therefore, what is desired is a compression device that provides uniform pressure distribution across the treatment area while moldably engaging the complex anatomical geometry of the ear to promote restoration of the ear to its pre-injury form.BRIEF SUMMARY

[0006] The present disclosure relates to compression devices for treating auricular hematoma, which is a subperichondrial collection of blood resulting from blunt force trauma to the ear. The compression devices described herein provide moldable magnetic compression systems that conform to the natural contours of the ear anatomy while applying therapeutic pressure to promote reattachment of the perichondrium to the underlying cartilage. The devices address limitations of existing treatment approaches by combining non-invasive magnetic compression with anatomically conforming moldable components.

[0007] In one aspect, the present disclosure may be a compression device for treating auricular hematoma at a triangular fossa region of an ear, comprising: an anterior compression assembly including: an anterior housing having a load-distributing geometry configured to span the triangular fossa region, the anterior housing defining at least one anterior cover; at least one anterior magnet disposed within the anterior cover and having a first magnetic polarity orientation; and a moldable compression body coupled to the anterior housing, the moldable compression body having an anatomical interface surface configured to conformably engage contours of the triangular fossa region, wherein the moldable compression body comprising a thermally moldable elastomeric material encapsulated and having a contourable surface configured to conformably engage the ridged triangular fossa region; and a posterior assembly configured to be positioned on a posterior auricular surface opposite the anterior compression assembly, the posterior assembly including a posterior housing and at least one posterior magnet coupled to the posterior housing and having a second magnetic polarity orientation opposite the first magnetic polarity orientation, whereby the at least one anterior magnet and the at least one posterior magnet are magnetically attracted to one another to apply compressive force across ear tissue positioned therebetween.

[0008] Tn another aspect, the present disclosure may be a compression device for treating auricular hematoma at a conchal bowl region of an ear, comprising: an anterior compression assembly comprising: an anterior housing defining an anterior cover; at least one anterior magnet retained within the anterior cover and oriented with a first polarity; and a moldable compression body coupled to the anterior housing, the moldable compression body comprising a thermally moldable elastomeric material and having a contourable surface configured to conformably engage the concave conchal bowl region; and a posterior assembly configured for positioning against a posterior auricular surface, the posterior assembly including a posterior housing and at least one posterior magnet disposed within the posterior housing and oriented with a second polarity opposite the first polarity, wherein magnetic attraction between the at least one anterior magnet and the at least one posterior magnet generates compressive force along a compression axis extending through ear tissue positioned between the anterior compression assembly and the posterior assembly.

[0009] In yet another aspect, the present disclosure may be a method of treating auricular hematoma, comprising: positioning an anterior compression assembly against an anterior surface of an ear at a location of the auricular hematoma, the anterior compression assembly including a thermally moldable elastomeric material and having a contourable surface configured to conformably engage and at least one anterior magnet; positioning a posterior magnetic assembly against a posterior surface of the ear opposite the anterior compression assembly, the posterior magnetic assembly including at least one posterior magnet having a magnetic polarity opposite to a magnetic polarity of the at least one anterior magnet; magnetically coupling the anterior compression assembly to the posterior magnetic assembly through ear tissue, whereby magnetic attraction between the at least one anterior magnet and the at least one posterior magnet may apply compressive force across a cartilage-perichondrium interface of the ear; conforming the moldable compression body to contours of the ear at the location of the auricular hematoma; and maintaining compressive engagement between the anterior compression assembly and the posterior magnetic assembly for a treatment duration sufficient to promote reattachment of perichondrium to underlying cartilage.BRIEF DESCRIPTION OF THE DRAWINGS

[0010] The present invention will become more fully understood from the detailed description and the accompanying drawings, wherein:

[0011] FIG. 1 is an isometric view of a moldable magnet system for treating auricular hematoma in accordance with an embodiment of the present disclosure;

[0012] FIG. 2 is an exploded view of the moldable magnet system of FIG. 1;

[0013] FIG. 3 is another exploded isometric view of the moldable magnet system of FIG. 1;

[0014] FIG. 4 is a top view of the moldable magnet system of FIG. 1;

[0015] FIG. 5 is a side view of the moldable magnet system of FIG. 1;

[0016] FIG. 6 is a front view of the moldable magnet system of FIG. 1;

[0017] FIG. 7A is an isometric view of an anterior magnet of the compression device of FIGS.1-6;

[0018] FIG. 7B is an isometric view of a posterior magnet of the compression device of FIGS.1-6;

[0019] FIG. 8 is an isometric view of a compression device for treating auricular hematoma in accordance with another embodiment of the present disclosure;

[0020] FIG. 9 is an exploded isometric view of the compression device of FIG. 8;

[0021] FIG. 10 is another exploded isometric view of the compression device of FIG. 8;

[0022] FIG. 11 is a top view of a connecting component of the compression device of FIG. 8;

[0023] FIG. 12 is a side view of the compression device of FIG. 8;

[0024] FIG. 13 is a front view of a component of the compression device of FIG. 8;

[0025] FIG. 14A is an isometric view of an anterior magnet of the compression device of FIGS. 8-13;

[0026] FIG. 14B is an isometric view of a posterior magnet of the compression device of FIGS. 8-13;

[0027] FIG. 15 is an illustration of the compression device of FIG. 1;

[0028] FIG. 16 is an illustration of the compression device of FIG. 15 positioned on a user's ear; and

[0029] FIG. 17 is a perspective view of a moldable component of the compression device of FIG. 15 after being conformed to the user's ear.DETAILED DESCRIPTION

[0030] The following description of the preferred embodiment(s) is merely exemplary in nature and is in no way intended to limit the invention, its application, or uses.

[0031] The description of illustrative embodiments according to principles of the present invention is intended to be read in connection with the accompanying drawings, which are to be considered part of the entire written description. In the description of embodiments of the invention disclosed herein, any reference to direction or orientation is merely intended for convenience of description and is not intended in any way to limit the scope of the present invention. Relative terms such as “lower,” “upper,” “horizontal,” “vertical,” “above,” “below,” “up,” “down,” “left,” “right,” “top” and “bottom” as well as derivatives thereof (e.g., “horizontally,” “downwardly,” “upwardly,” etc.) should be construed to refer to the orientation as then described or as shown in the drawing under discussion. These relative terms are for convenience of description only and do not require that the apparatus be constructed or operated in a particular orientation unless explicitly indicated as such.

[0032] Terms such as “attached,” “affixed,” “connected,” “coupled,” “interconnected,” and similar refer to a relationship wherein structures are secured or attached to one another either directly or indirectly through intervening structures, as well as both movable or rigid attachments or relationships, unless expressly described otherwise. Moreover, the features and benefits of the invention are illustrated by reference to the preferred embodiments. Accordingly, the invention expressly should not be limited to such preferred embodiments illustrating some possible nonlimiting combinations of features that may exist alone or in other combinations of features; the scope of the invention being defined by the claims appended hereto.

[0033] Features of the present invention(s) may be implemented in software, hardware, firmware, or combinations thereof. In particular, the various units that form a part of the control circuit described herein may comprise software, hardware, firmware, and combinations thereof. Each such “unit” may comprise its own processor, or it may be coupled to a processor that is used for all components of the control circuit, or some combination of this may occur. The computer programs described herein are not limited to any particular embodiment, and may be implemented in an operating system, application program, foreground or background processes, driver, or any combination thereof. The computer programs may be executed on a single computer or server processor or multiple computer or server processors.

[0034] Processors (also referred to as controllers or control units) described herein may be any central processing unit (CPU), microprocessor, micro-controller, computational, or programmable device or circuit configured for executing computer program instructions (e.g.,code). Various processors may be embodied in computer and / or server hardware of any suitable type (e.g., desktop, laptop, notebook, tablets, cellular phones, etc.) and may include all the usual ancillary components necessary to form a functional data processing device including without limitation a bus, software and data storage such as volatile and non-volatile memory, input / output devices, graphical user interfaces (GUIs), removable data storage, and wired and / or wireless communication interface devices including Wi-Fi, Bluetooth, LAN, etc. In one particular embodiment, a processor unit may reside on the device ( as described herein) itself and all processing can be done internally and integrally on the device without limitation and without the need of any outside resource.

[0035] Computer-executable instructions or programs (e.g., software or code) and data described herein may be programmed into and tangibly embodied in a non-transitory computer-readable medium that is accessible to and retrievable by a respective processor as described herein which configures and directs the processor to perform the desired functions and processes by executing the instructions encoded in the medium. A device embodying a programmable processor configured to such non-transitory computer-executable instructions or programs may be referred to as a “programmable device,” or “device,” and multiple programmable devices in mutual communication may be referred to as a “programmable system.” It should be noted that non-transitory “computer-readable medium” as described herein may include, without limitation, any suitable volatile or non-volatile memory including random access memory (RAM) and various types thereof, read-only memory (ROM) and various types thereof, USB flash memory, and magnetic or optical data storage devices (e.g., internal / external hard disks, floppy discs, magnetic tape CD-ROM, DVD-ROM, optical disk, ZIP™ drive, Blu-ray disk, and others), which may be written to and / or read by a processor operably connected to the medium.

[0036] Referring to FIGS. 1-12 concurrently, the present disclosure relates to compression devices 100, 200 for treating auricular hematoma, a condition characterized by a subperichondrial collection of blood resulting from blunt force trauma to the ear. Auricular hematoma occurs when blood accumulates between the cartilage and the overlying perichondrium of the ear, disrupting the blood supply to the cartilage. Without treatment, auricular hematoma leads to fibrocartilaginous overgrowth and permanent deformity commonly referred to as cauliflower ear. The compression devices 100, 200 described herein address the treatment of auricular hematoma at two anatomically distinct regions of the ear: a triangular fossa region and a conchal bowl region.

[0037] Existing treatment approaches for auricular hematoma present several limitations that the compression devices 100, 200 described herein address. Rigid magnetic compression discs, while non-invasive, fail to conform to the complex three-dimensional contours of the ear anatomy. The flat opposing surfaces of rigid magnetic discs create localized pressure concentration at points of contact rather than distributing compressive force uniformly across the treatment area. This non-uniform pressure distribution results in inadequate compression at certain regions while potentially causing tissue damage at others, leading to poor cosmetic restoration of the ear to its pre-injury form.

[0038] Sutured bolster systems represent an alternative treatment approach that can restore the ear to its pre-injury form. However, sutured bolster systems require needles and sutures to be passed through the ear cartilage, creating an invasive procedure that causes patient discomfort. The sutures remain in place for extended treatment durations, typically one week or longer, during which time the risk of infection increases. Sutured bolster systems also require clinical visits for both application and removal, increasing the burden on both patients and healthcare providers.

[0039] Each compression device 100, 200 comprises an anterior compression assembly 104, 204, a posterior assembly 112, 212, and a connecting element that maintains spatial alignment between the anterior and posterior assemblies. The compression device 100 includes a structural frame 108 configured to wrap around a peripheral edge of the ear, while the compression device 200 includes a flexible retention element 208 configured to wrap around a helical rim of the ear.

[0040] The anterior compression assembly 104, 204 includes an anterior housing 116, 216 having a load-distributing geometry, at least one anterior magnet 124, 224, and a moldable compression body 128, 228. The moldable compression body 128, 228 has an anatomical interface surface configured to conformably engage contours of the respective treatment region. The posterior assembly 112, 212 includes a posterior housing 140, 232, a posterior cover 144, 236, and at least one posterior magnet 148, 240 having a magnetic polarity opposite to the anterior magnet 124, 224. Magnetic attraction between the anterior magnets 124, 224 and the posterior magnets 148, 240 generates compressive force along a compression axis extending through the ear tissue positioned therebetween.

[0041] The compression devices 100, 200 provide several technical and clinical benefits. The load-distributing anterior housings 116, 216 distribute compressive force across the treatment area, reducing localized pressure points that could cause tissue damage or patient discomfort. Themoldable compression bodies 128, 228 conform to the natural contours of the ear anatomy, enabling improved restoration of natural ear contour by matching patient-specific ear geometry. The magnetic coupling between the anterior compression assembly 104, 204 and the posterior magnetic retention assembly 112, 212 provides non-invasive pressure maintenance without requiring sutures through the ear cartilage, eliminating the infection risk associated with sutured bolster systems. The compression devices 100, 200 can be applied and removed by the patient without requiring clinical visits, reducing the burden on healthcare providers.

[0042] Referring to FIGS. 1-7, the compression device 100 configured to treat auricular hematoma at a triangular fossa region of an ear is shown. The compression device 100 comprises three main components: an anterior compression assembly 104 configured to be positioned against an anterior surface of the ear at the triangular fossa region, a structural frame 108 configured to wrap around a peripheral edge of the ear, and a posterior assembly 112 configured to be positioned on a posterior auricular surface opposite the anterior compression assembly 104.

[0043] The anterior compression assembly 104 includes an anterior housing 116, an anterior cover 120, at least one anterior magnet 124, and a moldable compression body 128. The anterior housing 116 has a load-distributing geometry configured to span the triangular fossa region of the ear. The anterior cover 120 is defined by the anterior housing 116 and configured to receive and retain the anterior magnet 124. The moldable compression body 128 is coupled to the anterior housing 116 and has an anatomical interface surface configured to conformably engage contours of the triangular fossa region.

[0044] The anterior housing 116 comprises a rigid polymeric material configured to distribute compressive load across the triangular fossa region without localized pressure concentration. The rigid polymeric material provides sufficient structural rigidity to maintain the spatial relationship between the anterior cover 120 and the moldable compression body 128 while distributing the magnetic compressive force over a broader surface area than the magnets 124 alone would provide. The anterior housing 116 functions as a load-bearing structure that spreads the compressive force generated by the magnetic attraction across the treatment area, reducing point loading that could cause tissue damage or patient discomfort.

[0045] Continuing with FIGS. 4-6, the anterior compression assembly 104 has an overall height Hl in a range of 7 mm to 12 mm, for example, 9 mm, providing a low-profile configuration suitable for extended wear during the treatment period. The anterior compression assembly 104has an overall radius R1 in a range of 10 mm to 15 mm, for example, 12.5 mm. The anterior housing 116 defines the outer boundary of the anterior compression assembly 104 and has a radius in a range of 10 mm to 15 mm, for example, 12.5 mm, corresponding to the overall radius R1 of the anterior compression assembly 104. The anterior housing 116 has a thickness in a range of 1 mm to 4 mm, for example, 2.5 mm. The anterior cover 120 has a radius in a range of 8 mm to 15 mm, for example, 12.5 mm, corresponding to the diameter of the anterior magnet 124 to be retained therein.

[0046] The anterior housing 116 incorporates cut lines following ear geometry for better coverage and conformability to the triangular fossa region. The cut lines enable the anterior housing 116 to accommodate the curved surfaces and transitions present in the triangular fossa anatomy while maintaining the load-distributing function. The geometry of the anterior housing 116 is configured to follow the anatomical contours of the triangular fossa region, including the transition between the triangular fossa and adjacent antihelix structures.

[0047] Continuing with FIGS. 1-7, at least one anterior magnet 124 is disposed within the anterior cover 120 and has a first magnetic polarity orientation. The first magnetic polarity orientation of the anterior magnet 124 is configured to be opposite to a second magnetic polarity orientation of a corresponding posterior magnet, such that magnetic attraction between the anterior magnet 124 and the posterior magnet generates compressive force across ear tissue positioned therebetween. In the illustrated embodiment, an anterior magnet 124 is disposed within the anterior cover 120 of the anterior housing 116, with the anterior magnet 124 oriented with a magnetic polarity to provide magnetic coupling with a corresponding posterior magnet.

[0048] The anterior magnet 124 comprises a neodymium rare earth magnet. Neodymium rare earth magnets provide high magnetic field strength relative to magnet volume, enabling the compression device 100 to generate sufficient compressive pressure across ear tissue while maintaining a compact form factor suitable for extended wear. The neodymium rare earth magnet composition enables the anterior magnet 124 to produce compressive pressures in a therapeutically effective range when magnetically coupled with a corresponding posterior magnet through ear tissue having a thickness in a range of 1 mm to 4 mm. In some embodiments, the anterior magnet 124 comprises an N42 grade neodymium magnet. N42 grade neodymium magnets provide a balance between magnetic strength and cost effectiveness for auricular compression applications. The N42 grade designation indicates a maximum energy product that produces compressivepressures suitable for promoting perichondrium reattachment without causing tissue damage. In some embodiments, the anterior magnet 124 comprises an N52 grade neodymium magnet for higher magnetic strength. N52 grade neodymium magnets provide increased magnetic field strength compared to N42 grade magnets, enabling higher compressive pressures to be generated across thicker ear tissue or when greater compression is therapeutically indicated. The N52 grade designation represents a higher maximum energy product that produces stronger magnetic attraction between the anterior magnet 124 and the corresponding posterior magnet.

[0049] Continuing with FIG. 7A, the anterior magnet 124 comprises a disc-shaped magnet having a diameter DI in a range of 10 millimeters to 20 millimeters, for example, 15 millimeters. The disc-shaped configuration of the anterior magnet 124 provides a circular contact area that distributes magnetic force uniformly across the treatment region. The diameter DI of the anterior magnet 124 is selected to provide sufficient surface area for effective compression while fitting within the anatomical constraints of the triangular fossa region. The disc-shaped magnet has a thickness T1 in a range of 1 mm to 5 mm, for example, 3 mm, providing sufficient magnetic material volume to generate the desired compressive force while maintaining a low-profile configuration. In some embodiments, the diameter DI is approximately 15.9 mm (5 / 8 inch) and the thickness T1 is approximately 3.2 mm (1 / 8 inch), with a countersink configured to receive a #6 screw for mechanical attachment to the anterior housing 116. In some embodiments, the diameter DI is approximately 7.9 mm (5 / 16 inch) and the thickness T1 is approximately 7.9 mm (5 / 16 inch) in a cylinder / rod configuration, providing a compact footprint with increased magnetic material volume for applications requiring higher magnetic strength in a smaller diameter.

[0050] In some embodiments, the anterior magnet 124 comprises a countersunk ring magnet with a screw hole for mechanical attachment. The countersunk ring magnet configuration includes a central aperture with a countersunk profile that receives a fastener for securing the anterior magnet 124 to the anterior housing 116. The screw hole enables mechanical attachment of the anterior magnet 124 to the anterior cover 120 in addition to or as an alternative to press-fit retention, providing secure positioning of the anterior magnet 124 during use.

[0051] Continuing with FIGS. 1-7, the moldable compression body 128 is coupled to the anterior housing 116. The moldable compression body 128 has an anatomical interface surface configured to conformably engage contours of the triangular fossa region. The anatomical interface surface of the moldable compression body 128 presents a contoured geometry that matches theconcave surfaces and curved transitions present in the triangular fossa anatomy. The moldable compression body 128 enables the compression device 100 to conform to patient-specific ear geometry, providing uniform pressure distribution across the treatment area while restoring the ear to its pre-injury form.

[0052] The moldable compression body 128 comprises a deformable material 132 encapsulated within a flexible envelope 136. The flexible envelope 136 contains and retains the deformable material 132 while permitting the moldable compression body 128 to be shaped to conform to the contours of the triangular fossa region. The flexible envelope 136 comprises a thermoplastic polyurethane sheet having a thickness in a range of 0.015 mm to 0.5 mm, for example, 0.1 mm. The thermoplastic polyurethane sheet provides elasticity and high surface friction that promotes adhesion to the ear surface during use. The flexible envelope 136 is heat-sealed to encapsulate the deformable material 132 in a pillow-shaped container configuration.

[0053] The deformable material 132 comprises ethylene-vinyl acetate having a vinyl acetate content in a range of 28% to 40%, for example, 35%. The vinyl acetate content determines the mechanical properties of the ethylene-vinyl acetate material, with higher vinyl acetate content producing softer material with lower melting temperature. Ethylene-vinyl acetate having a vinyl acetate content of 28% provides a Shore A hardness of approximately 81 and a DSC melt temperature of approximately 75°C. Ethylene-vinyl acetate having a vinyl acetate content of 40% provides a Shore A hardness of approximately 53 and a DSC melt temperature of approximately 52°C. In some embodiments, the deformable material 132 comprises ethylene-vinyl acetate having a vinyl acetate content of approximately 20%, similar to mouthguard applications, providing a balance between moldability and structural retention after cooling.

[0054] In some embodiments, the deformable material 132 comprises a thermoplastic elastomer selected from the group consisting of thermoplastic polyurethane and poly caprolactone. Thermoplastic polyurethane provides elasticity and durability suitable for repeated molding cycles. Polycaprolactone moldable plastic becomes rigid when hardened after cooling from a softening temperature of approximately 66°C (150°F), providing a wax-like stiffness during the molding process and structural rigidity after cooling. The poly caprolactone material enables patient-specific molding by heating in hot water for approximately two minutes, shaping to the ear contours, and allowing the material to cool and harden in the molded configuration.

[0055] The moldable compression body 128 is overmolded onto the anterior housing 116 such that the deformable material 132 is integrally bonded to the anterior housing 116. The overmolding process creates a mechanical and chemical bond between the deformable material 132 and the anterior housing 116, preventing delamination during use. The overmolding configuration positions the deformable material 132 around the anterior cover 120 of the anterior housing 116, with the anterior housing 116 providing a load-bearing structure that prevents the magnets 124 from creeping into the moldable material over time.

[0056] In some embodiments, the moldable compression body 128 comprises a balloon filled with iron shavings that can be manipulated to conform to the concavities of the ear anteriorly. The iron shavings within the balloon are attracted to a posterior magnet positioned behind the ear, creating magnetic coupling that maintains the balloon in position against the anterior ear surface. The balloon configuration enables the moldable compression body 128 to be shaped by manual manipulation to match the specific contours of the triangular fossa region.

[0057] In some embodiments, the ferrous material filling the balloon comprises ferrous ball bearings of different sizes as an alternative to iron shavings. The ferrous ball bearings provide discrete ferromagnetic elements that can shift and rearrange within the balloon to conform to ear contours. In some embodiments, the ferrous material filling the balloon comprises magnetic ball bearings of different sizes, providing both ferromagnetic attraction to the posterior magnet and inter-particle magnetic attraction that influences the conformability characteristics of the moldable compression body 128.

[0058] In some embodiments, the moldable compression body 128 comprises magnetic putty contained within a compliant balloon. The magnetic putty provides a viscous ferromagnetic material that can be shaped to conform to ear contours while maintaining the shaped configuration through the viscosity of the putty material. The compliant balloon contains the magnetic putty and provides a smooth outer surface for contact with the ear tissue.

[0059] In some embodiments, the moldable compression body 128 comprises iron powder embedded in silicone material. The iron-embedded silicone provides a ferromagnetic moldable material with the biocompatibility and flexibility characteristics of silicone. In some embodiments, the moldable compression body 128 comprises iron powder mixed with hot glue in a thermoplastic formulation, enabling the moldable compression body 128 to be heated and shaped to patientspecific ear contours. In some embodiments, the moldable compression body 128 comprises ironpowder mixed with clear epoxy, providing a ferromagnetic material that can be molded to ear contours and cured to a rigid configuration.

[0060] In some embodiments, the compression device 100 utilizes flexible magnetic tape as the magnetic component. The flexible magnetic tape provides a conformable magnetic element that can follow curved surfaces of the ear anatomy. However, flexible magnetic tape provides a weaker magnetic field compared to neodymium rare earth magnets, which limits the compressive pressure that can be generated across ear tissue.

[0061] In some embodiments, the anterior compression assembly 104 comprises multiple small magnets arranged on a flexible substrate such as faux leather. The multiple magnets provide distributed magnetic attraction points across the treatment area while the flexible substrate enables the anterior compression assembly 104 to conform to curved ear surfaces. In some embodiments, the multiple magnets comprise coherent ring magnets for ease of assembly, with the ring magnet configuration enabling consistent magnetic pole orientation across the array. In some embodiments, the multiple magnets are embedded in Shore 10A platinum curing silicone on a flexible substrate, providing a soft, conformable magnetic array with biocompatible silicone encapsulation.

[0062] In some embodiments, the moldable compression body 128 comprises silicone wax encapsulated in thermoplastic polyurethane sheets. The silicone wax provides a moldable material with wax-like consistency that can be shaped to ear contours, while the thermoplastic polyurethane encapsulation provides a durable, elastic outer surface. The thermoplastic polyurethane sheets having a thickness of approximately 0.1 mm provide elasticity similar to latex gloves with high surface friction and heat-seal capability for encapsulating the silicone wax material.

[0063] The flexible envelope 136 comprises a thermoplastic polyurethane sheet having a thickness in a range of 0.015 millimeters to 0.5 millimeters, for example, 0.1 millimeters. The thermoplastic polyurethane sheet thickness determines the elasticity and durability characteristics of the flexible envelope 136. A thermoplastic polyurethane sheet having a thickness of 0.015 mm provides high elasticity and feels similar to plastic wrap while maintaining sufficient strength to contain the deformable material 132 without rupture during use. A thermoplastic polyurethane sheet having a thickness of 0.1 mm provides very high elasticity similar to latex gloves, with high surface friction that promotes adhesion to the ear surface during treatment. The 0.1 mm thickness thermoplastic polyurethane sheet heat-seals effectively with sufficient margin for manufacturingconsistency, making this thickness configuration suitable for production of the flexible envelope 136.

[0064] In some embodiments, the encapsulating material for the moldable compression body 128 comprises latex as an alternative to thermoplastic polyurethane. Latex provides high elasticity and conformability characteristics suitable for containing the deformable material 132 while permitting the moldable compression body 128 to be shaped to ear contours. The latex encapsulation provides a smooth outer surface for contact with ear tissue during treatment.

[0065] In some embodiments, the encapsulating material comprises silicone sheets. Silicone sheets provide biocompatibility and durability characteristics suitable for extended contact with skin during the treatment period. The silicone sheet encapsulation provides a non-reactive outer surface that reduces the potential for skin irritation during prolonged wear of the compression device 100.

[0066] The deformable material 132 has a Shore A hardness in a range of 20 to 60, for example, 40. The Shore A hardness of the deformable material 132 determines the conformability and pressure distribution characteristics of the moldable compression body 128. A Shore A hardness in the range of 20 to 60 provides sufficient softness for the deformable material 132 to conform to the complex three-dimensional contours of the triangular fossa region while maintaining sufficient structural integrity to distribute compressive force uniformly across the treatment area. The Shore A hardness range corresponds to ethylene-vinyl acetate formulations having vinyl acetate content in the range of 28% to 40%, with higher vinyl acetate content producing lower Shore A hardness values.

[0067] The anatomical interface surface of the moldable compression body 128 is configured to be heated to a softening temperature and subsequently molded to conform to a patient-specific contour of the triangular fossa region. The softening temperature enables the deformable material 132 to become pliable for shaping to the specific ear anatomy of an individual patient. Once the deformable material 132 cools below the softening temperature, the moldable compression body 128 retains the molded configuration, providing patient-specific conformability during the treatment period.

[0068] The ethylene-vinyl acetate material of the deformable material 132 is heated to approximately 260°F (127°C) for molding. At this temperature, the ethylene-vinyl acetate material becomes sufficiently pliable to be shaped to the contours of the triangular fossa region. The heatedethylene-vinyl acetate material is loaded into a mold and overmolded onto the anterior housing 116, with the material conforming to the mold geometry as the material cools and solidifies.

[0069] In some embodiments, the deformable material 132 is heated to 66°C (150°F) for moldable plastic applications. This lower heating temperature is suitable for polycaprolactone-based moldable plastic formulations, which soften at lower temperatures than ethylene-vinyl acetate. The 66°C heating temperature enables the deformable material 132 to be softened by immersion in hot water for approximately two minutes, shaped to the ear contours by manual manipulation, and allowed to cool and harden in the molded configuration.

[0070] Continuing with FIGS. 1-7, the posterior assembly 112 is configured to be positioned on a posterior auricular surface opposite the anterior compression assembly 104. The posterior assembly 112 includes a posterior housing 140, a posterior cover 144, and at least one posterior magnet 148. The posterior housing 140 supports the posterior magnet 148, and the posterior cover 144 encapsulates the posterior magnet 148. The posterior assembly 112 provides the magnetic counterpart to the anterior compression assembly 104, with the two assemblies working together to apply compressive force across ear tissue positioned therebetween. The posterior auricular surface presents a relatively flat anatomical surface compared to the complex contours of the anterior auricular surface, and the posterior assembly 112 is configured with geometry suited to this flat posterior anatomy.

[0071] The posterior assembly 112 has a height H2 in a range of 5 mm to 10 mm, for example, 7.66 mm. The difference in heights between the anterior compression assembly 104 and the posterior assembly 112 reflects the different anatomical requirements for conforming to the anterior and posterior auricular surfaces. The anterior compression assembly 104 includes the moldable compression body 128 that conforms to the concave contours of the triangular fossa region, requiring additional height to accommodate the moldable material. The posterior assembly 112 interfaces with the relatively flat posterior auricular surface and therefore requires less height to provide effective magnetic coupling.

[0072] The posterior assembly 112 has an overall radius R2 in a range of 7 mm to 11 mm, for example, 9 mm. The posterior housing 140 defines the outer boundary of the posterior assembly 112 and has a radius in a range of 7 mm to 11 mm, for example, 9 mm, corresponding to the overall radius R2 of the posterior assembly 112.

[0073] The posterior cover 144 is configured to encapsulate the at least one posterior magnet 148. The posterior cover 144 provides protection for the posterior magnet 148 and presents a smooth outer surface for contact with the posterior auricular surface during treatment. The posterior cover 144 has a reduced thickness profile configured for positioning against the posterior auricular surface. The reduced thickness profile of the posterior cover 144 enables the compression device 100 to be worn during extended treatment durations without causing discomfort from the posterior assembly 112 pressing against the head or pillow during sleep.

[0074] The posterior housing 140 retains the posterior magnet 148 using press-fit assembly for magnet retention without adhesives. The press-fit assembly configuration enables the posterior magnet 148 to be securely retained within the posterior housing 140 through mechanical interference fit, eliminating the need for adhesive bonding that could degrade over time or during exposure to moisture. The press-fit retention provides reliable positioning of the posterior magnet 148 relative to the posterior housing 140 throughout the treatment period.

[0075] The posterior magnet 148 has a second magnetic polarity orientation opposite the first magnetic polarity orientation of the anterior magnet 124. The opposite magnetic polarity orientations of the anterior magnet 124 and the posterior magnet 148 create magnetic attraction between the two magnets when positioned on opposite sides of the ear tissue. The anterior magnet 124 and the posterior magnet 148 are magnetically attracted to one another to apply compressive force across ear tissue positioned therebetween, with the magnetic attraction generating a compression axis that extends through the ear tissue from the anterior compression assembly 104 to the posterior assembly 112.

[0076] Continuing with FIGS. 1-7B, at least one posterior magnet 148 is disposed within the posterior cover 144 and has a second magnetic polarity orientation. The first magnetic polarity orientation of the posterior magnet 148 is configured to be opposite to a second magnetic polarity orientation of a corresponding anterior magnet, such that magnetic attraction between the anterior magnet 124 and the posterior magnet 148 generates compressive force across ear tissue positioned therebetween. In the illustrated embodiment, a posterior magnet 148 is disposed within the posterior cover 144 of the posterior housing 140, with the posterior magnet 148 oriented with a magnetic polarity to provide magnetic coupling with a corresponding anterior magnet.

[0077] The posterior magnet 148 comprises a neodymium rare earth magnet. Neodymium rare earth magnets provide high magnetic field strength relative to magnet volume, enabling thecompression device 100 to generate sufficient compressive pressure across ear tissue while maintaining a compact form factor suitable for extended wear. The neodymium rare earth magnet composition enables the posterior magnet 148 to produce compressive pressures in a therapeutically effective range when magnetically coupled with a corresponding anterior magnet through ear tissue having a thickness in a range of 1 mm to 4 mm. In some embodiments, the posterior magnet 148 comprises an N42 grade neodymium magnet. N42 grade neodymium magnets provide a balance between magnetic strength and cost effectiveness for auricular compression applications. The N42 grade designation indicates a maximum energy product that produces compressive pressures suitable for promoting perichondrium reattachment without causing tissue damage. In some embodiments, the posterior magnet 148 comprises an N52 grade neodymium magnet for higher magnetic strength. N52 grade neodymium magnets provide increased magnetic field strength compared to N42 grade magnets, enabling higher compressive pressures to be generated across thicker ear tissue or when greater compression is therapeutically indicated. The N52 grade designation represents a higher maximum energy product that produces stronger magnetic attraction between the posterior magnet 148 and the corresponding anterior magnet 124.

[0078] Continuing with FIG. 7B, the posterior magnet 148 comprises a disc-shaped magnet having a diameter D2 in a range of 10 millimeters to 20 millimeters, for example, 15 millimeters. The disc-shaped configuration of the posterior magnet 148 provides a circular contact area that distributes magnetic force uniformly across the treatment region. The diameter D2 of the posterior magnet 148 is selected to provide sufficient surface area for effective compression while fitting within the anatomical constraints of the triangular fossa region. The disc-shaped magnet has a thickness T2 in a range of 1 mm to 5 mm, for example, 3 mm, providing sufficient magnetic material volume to generate the desired compressive force while maintaining a low-profile configuration. In some embodiments, the diameter D2 is approximately 15.9 mm (5 / 8 inch) and the thickness T2 is approximately 3.2 mm (1 / 8 inch), with a countersink configured to receive a #6 screw for mechanical attachment to the posterior housing 140. In some embodiments, the diameter D2 is approximately 7.9 mm (5 / 16 inch) and the thickness T2 is approximately 7.9 mm (5 / 16 inch) in a cylinder / rod configuration, providing a compact footprint with increased magnetic material volume for applications requiring higher magnetic strength in a smaller diameter.

[0079] Tn some embodiments, the posterior magnet 148 comprises a countersunk ring magnet with a screw hole for mechanical attachment. The countersunk ring magnet configuration includes a central aperture with a countersunk profile that receives a fastener for securing the posterior magnet 148 to the posterior housing 140. The screw hole enables mechanical attachment of the posterior magnet 148 to the posterior cover 144 in addition to or as an alternative to press-fit retention, providing secure positioning of the posterior magnet 148 during use.

[0080] The structural frame 108 is coupled between the anterior compression assembly 104 and the posterior assembly 112. The structural frame 108 is configured to wrap around a peripheral edge of the ear to maintain spatial alignment between the anterior compression assembly 104 and the posterior assembly 112. The structural frame 108 provides a physical connection between the anterior and posterior assemblies 104, 112 that supplements the magnetic attraction, preventing the assemblies from separating or shifting during patient movement or sleep. The structural frame 108 has an overall length L0 in a range of 40 mm to 70 mm, for example, 55 mm. The center-to-center distance LI between the anterior cover 120 and the posterior cover 144 is in a range of 50 mm to 60 mm, for example, 55 mm, corresponding to the anatomical distance between treatment zones.

[0081] At least one anterior magnet 124 and at least one posterior magnet 148 are configured to generate a compressive pressure in a range of 20 mmHg to 300 mmHg across ear tissue having a thickness in a range of 1 millimeter to 4 millimeters. The compressive pressure range provides therapeutically effective compression for promoting reattachment of the perichondrium to the underlying cartilage while avoiding excessive pressure that could cause tissue damage or patient discomfort. The compressive pressure decreases as the separation distance between the anterior magnet 124 and the posterior magnet 148 increases due to variations in ear tissue thickness. For ear tissue having a thickness of approximately 1 mm, the compressive pressure is in a range of 200 mmHg to 300 mmHg. For ear tissue having a thickness of approximately 4 mm, the compressive pressure is in a range of 20 mmHg to 100 mmHg. The magnet grade, diameter, and thickness are selected to provide compressive pressure within the therapeutic range across the expected range of ear tissue thicknesses.

[0082] The compression device 100 is provided in small, medium, and large sizing options to accommodate different ear anatomies. The sizing options address the anatomical variability present across different patient populations, with ear dimensions varying based on age, sex, andindividual anatomical characteristics. The small sizing option is configured for patients with smaller ear dimensions, such as pediatric patients or adults with smaller ear anatomy. The medium sizing option is configured for patients with average ear dimensions. The large sizing option is configured for patients with larger ear dimensions. Each sizing option maintains the same functional configuration of the anterior compression assembly 104, posterior assembly 112, and structural frame 108, with dimensional scaling to accommodate the different ear sizes.

[0083] Referring to FIGS. 8-12, the compression device 200 is configured for treating auricular hematoma at a conchal bowl region of an ear. The compression device 200 represents a second embodiment that addresses the anatomical characteristics of the conchal bowl region, which presents a deeper concave structure with different dimensional characteristics than the triangular fossa region addressed by the compression device 100 described above. The conchal bowl region comprises a bowl-shaped depression in the central portion of the ear that requires a compression device with geometry adapted to engage the concave surfaces and curved transitions present in the conchal bowl anatomy. The compression device 200 comprises three main components: an anterior compression assembly 204 configured to be positioned against an anterior surface of the ear at the conchal bowl region, a flexible retention element 208 configured to wrap around a helical rim of the ear, and a posterior assembly 212 configured for positioning against a posterior auricular surface opposite the anterior compression assembly 204.

[0084] The anterior compression assembly 204 includes an anterior housing 216, an anterior cover 220, at least one anterior magnet 224, and a moldable compression body 228. The anterior housing 216 defines the anterior cover 220, which is configured to receive and retain the anterior magnet 224. The moldable compression body 228 is coupled to the anterior housing 216 and has a contoured surface configured to conformably engage the concave conchal bowl region. The anterior housing 216 provides structural support for the magnetic and moldable components of the anterior compression assembly 204 while distributing compressive load across the conchal bowl region.

[0085] The anterior housing 216 comprises a rigid polymeric material configured to distribute compressive load across the conchal bowl region without localized pressure concentration. The rigid polymeric material provides sufficient structural rigidity to maintain the spatial relationship between the anterior cover 220 and the moldable compression body 228 while distributing the magnetic compressive force over a broader surface area than the magnets 224 alone would provide.The anterior housing 216 functions as a load-bearing structure that spreads the compressive force generated by the magnetic attraction across the treatment area, reducing point loading that could cause tissue damage or patient discomfort.

[0086] As shown in FIGS. 11-14B, the anterior compression assembly 204 has an overall height H3 in a range of 10 mm to 15 mm, for example, 12 mm, providing a low-profde configuration suitable for extended wear during the treatment period. The anterior compression assembly 204 has an overall radius R3 in a range of 7 mm to 12 mm, for example, 9 mm. The anterior housing 216 defines the outer boundary of the anterior compression assembly 204 and has a radius in a range of 7 mm to 12 mm, for example, 9 mm, corresponding to the overall radius R3 of the anterior compression assembly 204. The anterior housing 216 has a thickness in a range of 1 mm to 4 mm, for example, 2.5 mm. The anterior cover 220 has a radius in a range of 6 mm to 10 mm, for example, 8 mm, corresponding to the diameter of the anterior magnet 224 to be retained therein.

[0087] In some embodiments, the anterior housing 216 comprises a curved profile configured to follow a transition contour between the conchal bowl region and an adjacent antihelix region of the ear. The curved profile of the anterior housing 216 accommodates the anatomical geometry where the conchal bowl transitions into the surrounding ear structures. The antihelix region presents a curved ridge that borders the conchal bowl, and the curved profile of the anterior housing 216 follows this transition contour to provide conformable engagement with the ear anatomy. The curved profile enables the anterior housing 216 to maintain contact with the ear surface across the transition zone between the conchal bowl and antihelix regions, distributing compressive force across a broader treatment area than a flat housing configuration would provide.

[0088] The flexible retention element 208 has an overall length L2 in a range of 40 mm to 70 mm, for example, 55 mm. The center-to-center distance L3 between the anterior cover 220 and the posterior cover 236 is in a range of 50 mm to 60 mm, for example, 55 mm, corresponding to the anatomical distance between treatment zones.

[0089] At least one anterior magnet 224 is disposed within the anterior cover 220 and has a first magnetic polarity orientation. The first magnetic polarity orientation of the anterior magnet 224 is configured to be opposite to a second magnetic polarity orientation of a corresponding posterior magnet, such that magnetic attraction between the anterior magnet 224 and the posterior magnet generates compressive force across ear tissue positioned therebetween. In the illustratedembodiment, an anterior magnet 224 is disposed within the anterior cover 220 of the anterior housing 216, with the anterior magnet 224 oriented with a magnetic polarity to provide magnetic coupling with a corresponding posterior magnet.

[0090] The anterior magnet 224 comprises a neodymium rare earth magnet. Neodymium rare earth magnets provide high magnetic field strength relative to magnet volume, enabling the compression device 200 to generate sufficient compressive pressure across ear tissue while maintaining a compact form factor suitable for extended wear. The neodymium rare earth magnet composition enables the anterior magnet 224 to produce compressive pressures in a therapeutically effective range when magnetically coupled with a corresponding posterior magnet through ear tissue having a thickness in a range of 1 mm to 4 mm. In some embodiments, the anterior magnet 224 comprises an N42 grade neodymium magnet. N42 grade neodymium magnets provide a balance between magnetic strength and cost effectiveness for auricular compression applications. In some embodiments, the anterior magnet 224 comprises an N52 grade neodymium magnet for higher magnetic strength.

[0091] The anterior magnet 224 comprises a disc-shaped magnet having a diameter D3 in a range of 10 millimeters to 20 millimeters, for example, 15 millimeters. The disc-shaped configuration of the anterior magnet 224 provides a circular contact area that distributes magnetic force uniformly across the treatment region. The diameter D3 of the anterior magnet 224 is selected to provide sufficient surface area for effective compression while fitting within the anatomical constraints of the conchal bowl region. The disc-shaped magnet has a thickness T3 in a range of 1 mm to 5 mm, for example, 3 mm, providing sufficient magnetic material volume to generate the desired compressive force while maintaining a low-profile configuration.

[0092] Continuing with FIGS. 8-14B, the moldable compression body 228 is coupled to the anterior housing 216. The moldable compression body 228 has an anatomical interface surface configured to conformably engage contours of the conchal bowl region. The anatomical interface surface of the moldable compression body 228 presents a contoured geometry that matches the concave surfaces and curved transitions present in the conchal bowl anatomy. The moldable compression body 228 enables the compression device 200 to conform to patient-specific ear geometry, providing uniform pressure distribution across the treatment area while restoring the ear to its pre-injury form.

[0093] The moldable compression body 228 comprises a thermally moldable elastomeric material. The thermally moldable elastomeric material comprises ethylene-vinyl acetate having a vinyl acetate content in a range of 28% to 40%, for example, 35%. The vinyl acetate content determines the mechanical properties of the ethyl ene-vinyl acetate material, with higher vinyl acetate content producing softer material with lower softening temperature. Ethylene-vinyl acetate having a vinyl acetate content of 28% provides a harder material with higher softening temperature, while ethylene-vinyl acetate having a vinyl acetate content of 40% provides a softer material with lower softening temperature. The vinyl acetate content in the range of 28% to 40% provides a balance between moldability during the shaping process and structural retention after cooling to maintain the molded configuration during the treatment period.

[0094] The thermally moldable elastomeric material has a softening temperature in a range of 45°C to 75°C, for example, 60°C. The softening temperature enables the moldable compression body 228 to become pliable for shaping to the specific ear anatomy of an individual patient when heated to the softening temperature. At temperatures below the softening temperature, the thermally moldable elastomeric material retains the molded configuration, providing patientspecific conformability during the treatment period. The softening temperature range of 45°C to 75°C enables the moldable compression body 228 to be softened by immersion in hot water or by application of localized heat, shaped to the contours of the conchal bowl region by manual manipulation or by pressing against the ear surface, and allowed to cool and harden in the molded configuration.

[0095] The thermally moldable elastomeric material has a Shore A hardness in a range of 20 to 55, for example, 35. The Shore A hardness of the thermally moldable elastomeric material determines the conformability and pressure distribution characteristics of the moldable compression body 228. A Shore A hardness in the range of 20 to 55 provides sufficient softness for the thermally moldable elastomeric material to conform to the complex three-dimensional contours of the conchal bowl region while maintaining sufficient structural integrity to distribute compressive force uniformly across the treatment area. The Shore A hardness range corresponds to ethylene-vinyl acetate formulations having vinyl acetate content in the range of 28% to 40%, with higher vinyl acetate content producing lower Shore A hardness values.

[0096] Continuing with FIGS. 8-14B, the posterior assembly 212 is configured to be positioned on a posterior auricular surface opposite the anterior compression assembly 204. Theposterior assembly 212 includes a posterior housing 232, a posterior cover 236, and at least one posterior magnet 240. The posterior housing 232 supports the posterior magnet 240, and the posterior cover 236 encapsulates the posterior magnet 240. The posterior assembly 212 provides the magnetic counterpart to the anterior compression assembly 204, with the two assemblies working together to apply compressive force across ear tissue positioned therebetween. The posterior auricular surface presents a relatively flat anatomical surface compared to the complex contours of the anterior auricular surface, and the posterior assembly 212 is configured with geometry suited to this flat posterior anatomy.

[0097] The posterior assembly 212 has an overall radius R4 in a range of 7 mm to 11 mm, for example, 9 mm. The posterior housing 232 defines the outer boundary of the posterior assembly 212 and has a radius in a range of 7 mm to 11 mm, for example, 9 mm, corresponding to the overall radius R4 of the posterior assembly 212. The posterior assembly 212 has a height H4 in a range of 3 mm to 8 mm, for example, 4 mm, providing a low-profile configuration that rests comfortably behind the ear without excessive protrusion.

[0098] The posterior cover 236 is configured to encapsulate the at least one posterior magnet 240. The posterior cover 236 provides protection for the posterior magnet 240 and presents a smooth outer surface for contact with the posterior auricular surface during treatment. The posterior cover 236 has a reduced thickness profile configured for positioning against the posterior auricular surface. The reduced thickness profile of the posterior cover 236 enables the compression device 200 to be worn during extended treatment durations without causing discomfort from the posterior assembly 212 pressing against the head or pillow during sleep.

[0099] The posterior housing 232 retains the posterior magnet 240 using press-fit assembly for magnet retention without adhesives. The press-fit assembly configuration enables the posterior magnet 240 to be securely retained within the posterior housing 232 through mechanical interference fit, eliminating the need for adhesive bonding that could degrade over time or during exposure to moisture. The press-fit retention provides reliable positioning of the posterior magnet 240 relative to the posterior housing 232 throughout the treatment period.

[0100] The posterior magnet 240 has a second magnetic polarity orientation opposite the first magnetic polarity orientation of the anterior magnet 224. The opposite magnetic polarity orientations of the anterior magnet 224 and the posterior magnet 240 create magnetic attraction between the two magnets when positioned on opposite sides of the ear tissue. The anterior magnet224 and the posterior magnet 240 are magnetically attracted to one another to apply compressive force across ear tissue positioned therebetween, with the magnetic attraction generating a compression axis that extends through the ear tissue from the anterior compression assembly 204 to the posterior assembly 212. When the compression device 200 is positioned for treatment of the conchal bowl region, the compression axis may be oriented substantially perpendicular to an anatomical plane defined by the conchal bowl region, with the anterior compression assembly 204 and the posterior assembly 212 aligned to apply compressive force normal to the tissue surface at the treatment location.

[0101] The posterior magnet 240 comprises a neodymium rare earth magnet. Neodymium rare earth magnets provide high magnetic field strength relative to magnet volume, enabling the compression device 200 to generate sufficient compressive pressure across ear tissue while maintaining a compact form factor suitable for extended wear. In some embodiments, the posterior magnet 240 comprises an N42 grade neodymium magnet. In some embodiments, the posterior magnet 240 comprises an N52 grade neodymium magnet for higher magnetic strength.

[0102] The posterior magnet 240 comprises a disc-shaped magnet having a diameter D4 in a range of 10 millimeters to 20 millimeters, for example, 15 millimeters. The disc-shaped configuration of the posterior magnet 240 provides a circular contact area that distributes magnetic force uniformly across the treatment region. The disc-shaped magnet has a thickness T4 in a range of 1 mm to 5 mm, for example, 3 mm, providing sufficient magnetic material volume to generate the desired compressive force while maintaining a low-profile configuration.

[0103] The at least one anterior magnet 224 and the at least one posterior magnet 240 are configured to generate a compressive pressure in a range of 20 mmHg to 300 mmHg across ear tissue having a thickness in a range of 1 millimeter to 4 millimeters. The compressive pressure range provides therapeutically effective compression for promoting reattachment of the perichondrium to the underlying cartilage while avoiding excessive pressure that could cause tissue damage or patient discomfort. The compressive pressure decreases as the separation distance between the anterior magnet 224 and the posterior magnet 240 increases due to variations in ear tissue thickness. For ear tissue having a thickness of approximately 1 mm, the compressive pressure is in a range of 200 mmHg to 300 mmHg. For ear tissue having a thickness of approximately 4 mm, the compressive pressure is in a range of 20 mmHg to 100 mmHg. Themagnet grade, diameter, and thickness are selected to provide compressive pressure within the therapeutic range across the expected range of ear tissue thicknesses.

[0104] The compression device 200 includes a flexible retention element 208 coupled between the anterior compression assembly 204 and the posterior assembly 212. The flexible retention element 208 is configured to wrap around a helical rim of the ear to maintain spatial alignment between the anterior compression assembly 204 and the posterior assembly 212. The flexible retention element 208 provides a physical connection between the anterior and posterior assemblies that supplements the magnetic attraction, preventing the assemblies from separating or shifting during patient movement or sleep.

[0105] The flexible retention element 208 comprises a silicone elastomer band having a thickness in a range of 1 millimeter to 3 millimeters, for example, 2 millimeters. The silicone elastomer material provides flexibility and elasticity that enables the flexible retention element 208 to conform to the curved helical rim of the ear while maintaining tension between the anterior compression assembly 204 and the posterior assembly 212. The silicone elastomer material provides biocompatibility for extended skin contact during the treatment period and resists degradation from exposure to moisture and body oils. The thickness range of 1 millimeter to 3 millimeters provides sufficient structural integrity for the flexible retention element 208 to maintain the spatial relationship between the anterior and posterior assemblies while remaining flexible enough to conform to the curved peripheral edge of the ear.

[0106] Referring to FIGS. 13-15, the compression device 100, 200 is configured for patient self-application without requiring an in-office visit. The magnetic coupling between the anterior compression assembly 104, 204 and the posterior assembly 112, 212 enables the patient to position the device on the ear without clinical assistance. The patient positions the anterior compression assembly 104, 204 against the anterior surface of the ear at the location of the auricular hematoma, then positions the posterior assembly 112, 212 against the posterior auricular surface. The magnetic attraction between the anterior magnets 124, 224 and the posterior magnets 148, 240 draws the two assemblies together through the ear tissue, applying compressive force across the cartilage-perichondrium interface. The structural frame 108 or flexible retention element 208 wraps around the peripheral edge of the ear to maintain spatial alignment between the anterior and posterior assemblies during patient movement and sleep.

[0107] Tn some embodiments, the compression device 100, 200 incorporates a hinge mechanism to facilitate application and removal, enabling the anterior compression assembly 104, 204 and the posterior assembly 112, 212 to be pivoted relative to one another during the application process. In some embodiments, the compression device 100, 200 incorporates an ear hook similar to earbud designs for retention, with the ear hook extending from the anterior compression assembly 104, 204 and curving around the upper portion of the ear to provide mechanical retention that supplements the magnetic coupling between the anterior and posterior assemblies.

[0108] The compression device 100, 200 is configured as a reusable product for multiple treatment applications. The anterior housing 116 or housing 216, the anterior magnets 124, 224, the posterior magnets 148, 240, and the structural frame 108 or flexible retention element 208 are constructed from durable materials that withstand repeated use cycles without degradation of functional performance. The moldable compression body 128 or moldable compression body 228 can be reheated to the softening temperature and reshaped to accommodate different patients or to adjust the molded configuration for improved conformability to the ear anatomy. The reusable configuration reduces the cost per treatment application compared to single-use devices, as the compression device 100, 200 can be cleaned and reapplied for subsequent treatment sessions. The durable construction of the compression device 100, 200 supports extended treatment durations in a range of 3 days to 14 days without material degradation or loss of compressive force generation capability.

[0109] In some embodiments, the compression device incorporates a hinge mechanism to facilitate application and removal. The hinge mechanism enables the anterior compression assembly and the posterior assembly to be pivoted relative to one another during the application process. The hinge mechanism provides a controlled separation between the anterior and posterior assemblies that enables the patient to position the ear tissue between the magnetic components before allowing the magnetic attraction to draw the assemblies together. The hinge mechanism facilitates removal of the compression device by enabling the patient to pivot the anterior and posterior assemblies apart against the magnetic attraction, separating the device from the ear without requiring the patient to overcome the full magnetic force simultaneously.

[0110] In some embodiments, the compression device incorporates an ear hook similar to earbud designs for retention. The ear hook extends from the anterior compression assembly and curves around the upper portion of the ear to provide mechanical retention that supplements themagnetic coupling between the anterior and posterior assemblies. The ear hook configuration follows the curved anatomy of the antihelix and superior crus regions of the ear, providing a secure fit that maintains the position of the compression device during patient movement and physical activity. The ear hook design draws from earbud retention mechanisms that have been developed for audio devices, adapting the retention geometry for the therapeutic compression application. The ear hook provides additional security against displacement of the compression device during sleep or athletic activity, reducing the potential for treatment interruption due to device dislodgement.

[0111] The compression device is configured as a reusable product for multiple treatment applications. The anterior housing, magnets, and structural frame are constructed from durable materials that withstand repeated use cycles without degradation of functional performance. The moldable compression body can be reheated to the softening temperature and reshaped to accommodate different patients or to adjust the molded configuration for improved conformability to the ear anatomy. The reusable configuration reduces the cost per treatment application compared to single-use devices, as the compression device can be cleaned and reapplied for subsequent treatment sessions. The reusable design enables the compression device to be maintained by the patient for treatment of recurrent auricular hematoma episodes that may occur during continued participation in contact sports. The durable construction of the compression device supports extended treatment durations in a range of 3 days to 14 days without material degradation or loss of compressive force generation capability.

[0112] Continuing with FIGS. 13-15, a method of treating auricular hematoma is described. It should be noted that while FIGS. 13-15 depict the compression device 100 configured for the triangular fossa region, the method applies equally to the compression device 200 configured for the conchal bowl region, and accordingly both embodiments are referenced throughout the following description. The method comprises positioning an anterior compression assembly 104, 204 against an anterior surface of an ear at a location of the auricular hematoma. The anterior compression assembly 104, 204 includes a moldable compression body 128, 228 and at least one anterior magnet 124, 224. As shown in FIG. 14, the anterior compression assembly 104, 204 is positioned within the concha region of the ear, with the moldable compression body 128, 228 engaging the contoured anterior surface at the treatment location.

[0113] The method comprises positioning a posterior magnetic assembly 112, 212 against a posterior surface of the ear opposite the anterior compression assembly 104, 204. The posterior assembly 112, 212 includes at least one posterior magnet 148, 240 having a magnetic polarity opposite to a magnetic polarity of the at least one anterior magnet 124, 224. The opposite magnetic polarity orientations of the anterior magnet 124, 224 and the posterior magnet 148, 240 create magnetic attraction when the two assemblies are positioned on opposite sides of the ear tissue.

[0114] The method comprises magnetically coupling the anterior compression assembly 104, 204 to the posterior magnetic assembly 112, 212 through ear tissue. Magnetic attraction between the at least one anterior magnet 124, 224 and the at least one posterior magnet 148, 240 applies compressive force across a cartilage-perichondrium interface of the ear. The magnetic coupling draws the anterior compression assembly 104, 204 and the posterior magnetic assembly 112, 212 toward one another through the ear tissue, generating a compression axis that extends through the cartilage-perichondrium interface where reattachment is desired.

[0115] The method comprises conforming the moldable compression body 128, 228 to contours of the ear at the location of the auricular hematoma. As shown in FIG. 16, the moldable compression body 128, 228 exhibits an irregular, organic shape after being conformed to a user's ear, demonstrating the conformable nature of the moldable compression body 128, 228 that adapts to the complex contours of the human ear anatomy. The conforming step enables the compression device 100, 200 to restore the ear to its pre-injury form by recreating the natural curvatures of the ear during the treatment period.

[0116] In some embodiments, conforming the moldable compression body 128, 228 to contours of the ear comprises heating the moldable compression body 128, 228 to a softening temperature in a range of 45°C to 75°C prior to positioning the anterior compression assembly 104, 204 against the anterior surface of the ear. The softening temperature enables the moldable compression body 128, 228 to become pliable for shaping to the specific ear anatomy of an individual patient. The heated moldable compression body 128, 228 is shaped to the contours of the ear by manual manipulation or by pressing against the ear surface, then allowed to cool and harden in the molded configuration before or during positioning against the anterior surface of the ear.

[0117] In some embodiments, the moldable compression body 128, 228 comprises ethylenevinyl acetate having a vinyl acetate content in a range of 28% to 40%. The vinyl acetate contentdetermines the mechanical properties of the ethylene-vinyl acetate material, with higher vinyl acetate content producing softer material with lower softening temperature. Ethylene-vinyl acetate having a vinyl acetate content in the range of 28% to 40% provides a balance between moldability during the shaping process and structural retention after cooling to maintain the molded configuration during the treatment period.

[0118] The location of the auricular hematoma comprises at least one of a triangular fossa region and a conchal bowl region of the ear. The triangular fossa region presents a relatively shallow concavity in the upper portion of the ear, while the conchal bowl region presents a deeper concave structure in the central portion of the ear. The method is applicable to auricular hematoma occurring in either anatomical region, with the moldable compression body 128, 228 conforming to the specific contours of the treatment location.

[0119] The compressive force applied across the cartilage-perichondrium interface is in a range of 20 mmHg to 300 mmHg. The compressive force range provides therapeutically effective compression for promoting reattachment of the perichondrium to the underlying cartilage while avoiding excessive pressure that could cause tissue damage or patient discomfort. The compressive force varies based on the separation distance between the anterior magnet 124, 224 and the posterior magnet 148, 240, with higher compressive force generated when the ear tissue thickness is smaller and lower compressive force generated when the ear tissue thickness is larger.

[0120] The method comprises maintaining compressive engagement between the anterior compression assembly 104, 204 and the posterior magnetic assembly 112, 212 for a treatment duration sufficient to promote reattachment of perichondrium to underlying cartilage. The treatment duration is in a range of 3 days to 14 days. The treatment duration provides sufficient time for the perichondrium to reattach to the underlying cartilage, eliminating the potential space between the perichondrium and cartilage where fluid may reaccumulate. The structural frame 108 or flexible retention element 208 connecting the anterior moldable component and the posterior magnet assembly maintains the spatial relationship between the anterior and posterior portions during the treatment duration.

[0121] In some embodiments, the method comprises draining the auricular hematoma prior to positioning the anterior compression assembly 104, 204 against the anterior surface of the ear. Draining the auricular hematoma removes the subperichondrial collection of blood that has accumulated between the cartilage and the overlying perichondrium. The drainage step isperformed prior to application of the compression device 100, 200, enabling the compressive force to maintain contact between the perichondrium and the underlying cartilage during the healing process. The drainage may be performed using needle aspiration or incision and drainage techniques, with the compression device 100, 200 applied immediately following drainage to prevent reaccumulation of fluid in the potential space.

[0122] Maintaining compressive engagement is performed without suturing through cartilage of the ear, whereby the method provides a non-invasive treatment alternative to bolster application. The magnetic coupling between the anterior compression assembly 104, 204 and the posterior magnetic assembly 112, 212 generates compressive force without requiring needles or sutures to be passed through the ear cartilage. The non-invasive approach eliminates the infection risk associated with sutured bolster systems and reduces patient discomfort during both application and the treatment period. As shown in FIG. 16, the compression device 100, 200 is positioned on the ear without invasive attachment, with the magnetic attraction and flexible band maintaining the device in position throughout the treatment duration. The non-invasive treatment alternative reduces the burden on healthcare providers by eliminating the clinical visits required for suture placement and removal associated with traditional bolster application techniques.

[0123] The compression device 100, 200 is manufactured using a combination of manufacturing processes selected to produce the various components with appropriate material properties and dimensional tolerances. The flexible envelope 136 that encapsulates the deformable material 132 is manufactured using heat sealing press and die cutting processes. The heat sealing press process joins thermoplastic polyurethane sheets along a peripheral seam to form a sealed enclosure that contains the deformable material 132. The heat sealing process applies controlled temperature and pressure to the thermoplastic polyurethane sheets, causing the material at the seam interface to soften and fuse together, creating a hermetic seal that prevents leakage of the deformable material 132 during use. The die cutting process shapes the sealed envelope to the desired geometry, removing excess material from the peripheral regions to produce the final envelope configuration. The heat sealing press and die cutting processes are performed using equipment that provides consistent temperature, pressure, and cutting force across production runs, enabling manufacture of flexible envelopes with repeatable dimensional characteristics and seal integrity.

[0124] The moldable compression body 128, 228 comprising ethylene-vinyl acetate is manufactured using injection overmolding processes. The injection overmolding process positions the anterior housing 116, 216 within a mold cavity, then injects heated ethylene-vinyl acetate material into the mold cavity around the anterior housing 116, 216. The ethylene-vinyl acetate material flows around the anterior housing 116, 216 and fills the mold cavity, conforming to the mold geometry as the material cools and solidifies. The injection overmolding process creates an integral bond between the ethylene- vinyl acetate material and the anterior housing 116, 216, with the ethylene-vinyl acetate material mechanically interlocking with features of the anterior housing 116, 216 and chemically bonding to the housing surface. The injection overmolding process produces moldable compression bodies with consistent material distribution and dimensional characteristics across production runs. The mold geometry defines the anatomical interface surface of the moldable compression body 128, 228, with the mold cavity shaped to produce the contoured surface that conformably engages the ear anatomy.

[0125] The anterior housing 116, 216 and posterior housing 140, 232 components are manufactured using 3D printing technology. In some embodiments, high-resolution color multijet printing is used, producing housing components with fine feature resolution and complex geometries that would be difficult to achieve using conventional molding processes. The multijet printing process deposits photopolymer material in thin layers, with each layer cured by ultraviolet light before deposition of the subsequent layer. The layer-by-layer deposition process enables production of housing components with internal features, undercuts, and complex curved surfaces that conform to ear anatomy. The color multijet printing capability enables production of housing components with multiple colors or color gradients for aesthetic purposes or for visual identification of component orientation during assembly. The 3D printing manufacturing approach enables rapid iteration of housing designs during development and production of patient-specific housing geometries when anatomical customization is indicated.

[0126] The compression device 100, 200 assembly utilizes press-fit assembly methods for magnet retention within the anterior cover 120, 220 of the anterior housing 116, 216 and the posterior housing 140, 232. The press-fit assembly method positions the magnet within the anterior cover 120, 220 or posterior housing 140, 232, then applies force to seat the magnet fully within the housing. The anterior cover 120, 220 and posterior housing 140, 232 are dimensioned with a slight interference fit relative to the magnet diameter, such that the magnet is retained within thehousing through mechanical friction between the magnet outer surface and the housing inner surface. The press-fit assembly method provides secure magnet retention without requiring adhesive bonding, enabling the magnet to be retained in position throughout the treatment period without risk of adhesive degradation or magnet displacement. The press-fit assembly is performed using compression jigs such as arbor presses that apply controlled force to seat the magnets consistently across production units.

[0127] The compression device 100, 200 is sterilized prior to packaging and distribution using sterilization methods compatible with the component materials. Ethylene oxide sterilization is performed by exposing the compression device 100, 200 to ethylene oxide gas within a sterilization chamber. The ethylene oxide gas penetrates the device materials and inactivates microorganisms through alkylation of cellular components. The ethylene oxide sterilization process is performed at controlled temperature, humidity, and gas concentration conditions, followed by aeration to remove residual ethylene oxide from the device materials. Ethylene oxide sterilization is compatible with the polymeric materials of the structural frame 108, moldable compression body 128, 228, and flexible envelope 136, as well as the metallic materials of the magnets. The ethylene oxide sterilization process does not degrade the mechanical properties or magnetic characteristics of the compression device 100, 200 components.

[0128] Gamma radiation sterilization is performed by exposing the compression device 100, 200 to ionizing radiation from a cobalt-60 or cesium-137 source. The gamma radiation penetrates the device materials and packaging, inactivating microorganisms through damage to cellular DNA and other biomolecules. The gamma radiation sterilization process is performed at controlled radiation dose levels sufficient to achieve sterility assurance while avoiding radiation-induced degradation of the device materials. Gamma radiation sterilization is compatible with the ethylenevinyl acetate material of the moldable compression body 128, 228 and the thermoplastic polyurethane material of the flexible envelope 136. The gamma radiation sterilization process provides terminal sterilization of the packaged compression device 100, 200, enabling the device to be maintained in sterile condition until the package is opened for use.

[0129] The compression device 100, 200 is provided in small, medium, and large sizing configurations to accommodate different ear anatomies. The sizing configurations address the anatomical variability present across different patient populations, with ear dimensions varying based on age, sex, and individual anatomical characteristics. The small sizing configuration isdimensioned for patients with smaller ear anatomy, including pediatric patients and adults with smaller ear dimensions. The medium sizing configuration is dimensioned for patients with average ear anatomy, representing the central portion of the ear size distribution across the patient population. The large sizing configuration is dimensioned for patients with larger ear anatomy, accommodating patients at the upper end of the ear size distribution. Each sizing configuration maintains the same functional arrangement of anterior compression assembly 104, 204, posterior assembly 112, 212, and structural frame 108 or flexible retention element 208, with dimensional scaling of the anterior housing 116, 216, moldable compression body 128, 228, and magnet spacing to accommodate the different ear sizes. The sizing configurations enable selection of a compression device 100, 200 that provides appropriate coverage and conformability for the specific ear anatomy of an individual patient.

[0130] While the invention has been described with respect to specific examples including presently preferred modes of carrying out the invention, those skilled in the art will appreciate that there are numerous variations and permutations of the above described systems and techniques. It is to be understood that other embodiments may be utilized and structural and functional modifications may be made without departing from the scope of the present invention. Thus, the spirit and scope of the invention should be construed broadly as set forth in the appended claims.

[0131] EXEMPLARY CLAIMS

[0132] Exemplary Claim 1. A compression device for treating auricular hematoma at a triangular fossa region of an ear, comprising: an anterior compression assembly including: an anterior housing having a load-distributing geometry configured to span the triangular fossa region, the anterior housing defining at least one anterior cover; at least one anterior magnet disposed within the anterior cover and having a first magnetic polarity orientation; and a moldable compression body coupled to the anterior housing, the moldable compression body having an anatomical interface surface configured to conformably engage contours of the triangular fossa region, wherein the moldable compression body comprises a deformable material encapsulated within a flexible envelope; and a posterior assembly configured to be positioned on a posterior auricular surface opposite the anterior compression assembly, the posterior assembly including a posterior housing, a posterior cover configured to encapsulate at least one posterior magnet, and the at least one posterior magnet coupled to the posterior housing and having a second magnetic polarity orientation opposite the first magnetic polarity orientation, whereby the at least oneanterior magnet and the at least one posterior magnet are magnetically attracted to one another to apply compressive force across ear tissue positioned therebetween.

[0133] Exemplary Claim 2. The compression device according to exemplary claim 1, wherein the at least one anterior magnet comprises a neodymium rare earth magnet.

[0134] Exemplary Claim 3. The compression device according to exemplary claim 1 or claim 2, wherein the at least one anterior magnet comprises a disc-shaped magnet having a diameter in a range of 10 millimeters to 20 millimeters.

[0135] Exemplary Claim 4. The compression device according to any one of exemplary claims 1 to 3, wherein the anterior housing comprises a rigid polymeric material configured to distribute compressive load across the triangular fossa region without localized pressure concentration.

[0136] Exemplary Claim 5. The compression device according to any one of exemplary claims 1 to 4, wherein the deformable material comprises ethylene-vinyl acetate having a vinyl acetate content in a range of 28% to 40%.

[0137] Exemplary Claim 6. The compression device according to any one of exemplary claims 1 to 4, wherein the deformable material comprises a thermoplastic elastomer selected from the group consisting of thermoplastic polyurethane, thermoplastic elastomer, and polycaprolactone.

[0138] Exemplary Claim 7. The compression device according to any one of exemplary claims 1 to 6, wherein the moldable compression body is overmolded onto the anterior housing such that the deformable material is integrally bonded to the anterior housing.

[0139] Exemplary Claim 8. The compression device according to any one of exemplary claims 1 to 7, wherein the flexible envelope comprises a thermoplastic polyurethane sheet having a thickness in a range of 0.05 millimeters to 0.5 millimeters.

[0140] Exemplary Claim 9. The compression device according to any one of exemplary claims 1 to 8, wherein the deformable material has a Shore A hardness in a range of 20 to 60.

[0141] Exemplary Claim 10. The compression device according to any one of exemplary claims 1 to 9, further comprising a structural frame coupled between the anterior compression assembly and the posterior assembly, the structural frame configured to wrap around a peripheral edge of the ear to maintain spatial alignment between the anterior compression assembly and the posterior assembly.

[0142] Exemplary Claim 11. The compression device according to exemplary claim 10, wherein the structural frame comprises a silicone elastomer.

[0143] Exemplary Claim 12. The compression device according to any one of exemplary claims 1 to 11, wherein the posterior cover has a reduced thickness profile configured for positioning against the posterior auricular surface.

[0144] 13. The compression device according to any one of claims 1 to 12, wherein the anatomical interface surface of the moldable compression body is configured to be heated to a softening temperature and subsequently molded to conform to a patient-specific contour of the triangular fossa region.

[0145] 14. The compression device according to any one of claims 1 to 13, wherein the at least one anterior magnet and the at least one posterior magnet are configured to generate a compressive pressure in a range of 20 mmHg to 300 mmHg across ear tissue having a thickness in a range of 1 millimeter to 4 millimeters.

[0146] Exemplary Claim 15. A compression device for treating auricular hematoma at a conchal bowl region of an ear, comprising: an anterior compression assembly comprising: an anterior housing defining an anterior cover; at least one anterior magnet retained within the anterior cover and oriented with a first polarity; and a moldable compression body coupled to the anterior housing, the moldable compression body comprising a thermally moldable elastomeric material and having a contoured surface configured to conformably engage the concave conchal bowl region; and a posterior assembly configured for positioning against a posterior auricular surface, the posterior assembly including a posterior housing and at least one posterior magnet disposed within the posterior housing and oriented with a second polarity opposite the first polarity, wherein magnetic attraction between the at least one anterior magnet and the at least one posterior magnet generates compressive force along a compression axis extending through ear tissue positioned between the anterior compression assembly and the posterior assembly.

[0147] Exemplary Claim 16. The compression device according to exemplary claim 15, wherein the at least one anterior magnet comprises a neodymium rare earth magnet having a diameter in a range of 12 millimeters to 18 millimeters.

[0148] Exemplary Claim 17. The compression device according to exemplary claim 15 or claim 16, wherein the thermally moldable elastomeric material comprises ethylene-vinyl acetate having a vinyl acetate content in a range of 28% to 40%.

[0149] Exemplary Claim 18. The compression device according to any one of exemplary claims 15 to 17, wherein the thermally moldable elastomeric material has a softening temperature in a range of 45°C to 75°C.

[0150] Exemplary Claim 19. The compression device according to any one of exemplary claims 15 to 18, wherein the moldable compression body is overmolded onto the anterior housing such that the thermally moldable elastomeric material is integrally bonded to the anterior housing.

[0151] Exemplary Claim 20. The compression device according to any one of exemplary claims 15 to 19, wherein the anterior housing comprises a curved profde configured to follow a transition contour between the conchal bowl region and an adjacent antihelix region of the ear.

[0152] Exemplary Claim 21. The compression device according to any one of exemplary claims 15 to 20, wherein the thermally moldable elastomeric material has a Shore A hardness in a range of 20 to 55.

[0153] Exemplary Claim 22. The compression device according to any one of exemplary claims 15 to 21, further comprising a flexible retention element coupled between the anterior compression assembly and the posterior assembly, the flexible retention element configured to wrap around a helical rim of the ear.

[0154] Exemplary Claim 23. The compression device according to exemplary claim 22, wherein the flexible retention element comprises a silicone elastomer band having a thickness in a range of 1 millimeter to 3 millimeters.

[0155] Exemplary Claim 24. The compression device according to any one of exemplary claims 15 to 23, wherein the posterior housing comprises a low-profile cover element having a thickness of less than 5 millimeters, the low-profile cover element configured to rest against the flat posterior auricular surface.

[0156] Exemplary Claim 25. The compression device according to any one of exemplary claims 15 to 24, wherein the at least one anterior magnet and the at least one posterior magnet are configured to generate a compressive pressure in a range of 30 mmEIg to 200 mmHg when separated by ear tissue having a thickness in a range of 2 millimeters to 4 millimeters.

[0157] Exemplary Claim 26. The compression device according to any one of exemplary claims 15 to 25, wherein the anterior compression assembly and the posterior assembly define a compression axis oriented substantially perpendicular to an anatomical plane of the conchal bowl region.

[0158] Exemplary Claim 27. The compression device according to any one of exemplary claims 15 to 26, wherein the posterior auricular surface comprises a flat posterior auricular surface.

[0159] Exemplary Claim 28. A method of treating auricular hematoma, comprising: positioning an anterior compression assembly against an anterior surface of an ear at a location of the auricular hematoma, the anterior compression assembly including a moldable compression body and at least one anterior magnet; positioning a posterior magnetic assembly against a posterior surface of the ear opposite the anterior compression assembly, the posterior magnetic assembly including at least one posterior magnet having a magnetic polarity opposite to a magnetic polarity of the at least one anterior magnet; magnetically coupling the anterior compression assembly to the posterior magnetic assembly through ear tissue, whereby magnetic attraction between the at least one anterior magnet and the at least one posterior magnet applies compressive force across a cartilage-perichondrium interface of the ear; conforming the moldable compression body to contours of the ear at the location of the auricular hematoma; and maintaining compressive engagement between the anterior compression assembly and the posterior magnetic assembly for a treatment duration sufficient to promote reattachment of perichondrium to underlying cartilage.

[0160] Exemplary Claim 29. The method according to exemplary claim 28, wherein conforming the moldable compression body to contours of the ear comprises heating the moldable compression body to a softening temperature in a range of 45°C to 75°C prior to positioning the anterior compression assembly against the anterior surface of the ear.

[0161] Exemplary Claim 30. The method according to exemplary claim 29, wherein the moldable compression body comprises ethylene-vinyl acetate having a vinyl acetate content in a range of 28% to 40%.

[0162] Exemplary Claim 31. The method according to any one of exemplary claims 28 to 30, wherein the location of the auricular hematoma comprises at least one of a triangular fossa region and a conchal bowl region of the ear.

[0163] Exemplary Claim 32. The method according to any one of exemplary claims 28 to 31, wherein the compressive force applied across the cartilage-perichondrium interface is in a range of 20 mmHg to 300 mmHg.

[0164] Exemplary Claim 33. The method according to any one of exemplary claims 28 to 32, wherein the treatment duration is in a range of 3 days to 14 days.

[0165] Exemplary Claim 34. The method according to any one of exemplary claims 28 to 33, further comprising draining the auricular hematoma prior to positioning the anterior compression assembly against the anterior surface of the ear.

[0166] Exemplary Claim 35. The method according to any one of exemplary claims 28 to 34, wherein maintaining compressive engagement is performed without suturing through cartilage of the ear, whereby the method provides a non-invasive treatment alternative to bolster application.

Claims

CLAIMSWHAT IS CLAIMED IS:

1. A compression device for treating auricular hematoma at a triangular fossa region of an ear, comprising:an anterior compression assembly including:an anterior housing having a load-distributing geometry configured to span the triangular fossa region, the anterior housing defining at least one anterior cover;at least one anterior magnet disposed within the anterior cover and having a first magnetic polarity orientation; anda moldable compression body coupled to the anterior housing, the moldable compression body having an anatomical interface surface configured to conformably engage contours of the triangular fossa region, wherein the moldable compression body comprises a deformable material; anda posterior assembly configured to be positioned on a posterior auricular surface opposite the anterior compression assembly, the posterior assembly including a posterior housing, a posterior cover configured to encapsulate at least one posterior magnet, and the at least one posterior magnet coupled to the posterior housing and having a second magnetic polarity orientation opposite the first magnetic polarity orientation,wherein at least one anterior magnet and at least one posterior magnet are magnetically attracted to one another to apply compressive force across ear tissue positioned there between.

2. The compression device according to claim 1, wherein the at least one anterior magnet comprises a neodymium rare earth magnet.

3. The compression device according to claim 1 or claim 2, wherein the at least one anterior magnet comprises a disc-shaped magnet having a diameter in a range of 10 millimeters to 20 millimeters.

4. The compression device according to any one of claims 1 to 3, wherein the anterior housing comprises a rigid polymeric material configured to distribute compressive load across the triangular fossa region without localized pressure concentration.

5. The compression device according to any one of claims 1 to 4, wherein the deformable material comprises ethylene-vinyl acetate having a vinyl acetate content in a range of 28% to 40%.

6. The compression device according to any one of claims 1 to 4, wherein the deformable material comprises a thermoplastic elastomer selected from the group consisting of thermoplastic polyurethane, thermoplastic elastomer, and polycaprolactone.

7. The compression device according to any one of claims 1 to 6, wherein the moldable compression body is overmolded onto the anterior housing such that the deformable material is integrally bonded to the anterior housing.

8. The compression device according to any one of claims 1 to 7, wherein the flexible envelope comprises a thermoplastic polyurethane sheet having a thickness in a range of 0.05 millimeters to 0.5 millimeters.

9. The compression device according to any one of claims 1 to 8, wherein the deformable material has a Shore A hardness in a range of 20 to 60.

10. The compression device according to any one of claims 1 to 9, further comprising a structural frame coupled between the anterior compression assembly and the posterior assembly, the structural frame configured to wrap around a peripheral edge of the ear to maintain spatial alignment between the anterior compression assembly and the posterior assembly.

11. The compression device according to claim 10, wherein the structural frame comprises a silicone elastomer.

12. The compression device according to any one of claims 1 to 11, wherein the posterior cover has a reduced thickness profile configured for positioning against the posterior auricular surface.

13. The compression device according to any one of claims 1 to 12, wherein the anatomical interface surface of the moldable compression body is configured to be heated to a softening temperature and subsequently molded to conform to a patient-specific contour of the triangular fossa region.

14. The compression device according to any one of claims 1 to 13, wherein the at least one anterior magnet and the at least one posterior magnet are configured to generate a compressive pressure in a range of 20 mmHg to 300 mmHg across ear tissue having a thickness in a range of 1 millimeter to 4 millimeters.

15. A compression device for treating auricular hematoma at a conchal bowl region of an ear, comprising:an anterior compression assembly comprising:an anterior housing defining an anterior cover;at least one anterior magnet retained within the anterior cover and oriented with a first polarity; anda moldable compression body coupled to the anterior housing, the moldable compression body comprising a thermally moldable elastomeric material and having a contoured surface configured to conformably engage the concave conchal bowl region; anda posterior assembly configured for positioning against a posterior auricular surface, the posterior assembly including a posterior housing and at least one posterior magnet disposed within the posterior housing and oriented with a second polarity opposite the first polarity, wherein magnetic attraction between the at least one anterior magnet and the at least one posterior magnet generates compressive force along a compression axis extending through ear tissue positioned between the anterior compression assembly and the posterior assembly.

16. The compression device according to claim 15, wherein the at least one anterior magnet comprises a neodymium rare earth magnet having a diameter in a range of 12 millimeters to 18 millimeters.

17. The compression device according to claim 15 or claim 16, wherein the thermally moldable elastomeric material comprises ethylene-vinyl acetate having a vinyl acetate content in a range of 28% to 40%.

18. The compression device according to any one of claims 15 to 17, wherein the thermally moldable elastomeric material has a softening temperature in a range of 45°C to 75°C.

19. The compression device according to any one of claims 15 to 18, wherein the moldable compression body is overmolded onto the anterior housing such that the thermally moldable elastomeric material is integrally bonded to the anterior housing.

20. The compression device according to any one of claims 15 to 19, wherein the anterior housing comprises a curved profile configured to follow a transition contour between the conchal bowl region and an adjacent antihelix region of the ear.

21. The compression device according to any one of claims 15 to 20, wherein the thermally moldable elastomeric material has a Shore A hardness in a range of 20 to 55.

22. The compression device according to any one of claims 15 to 21, further comprising a flexible retention element coupled between the anterior compression assembly and the posterior assembly, the flexible retention element configured to wrap around a helical rim of the ear.

23. The compression device according to claim 22, wherein the flexible retention element comprises a silicone elastomer band having a thickness in a range of 1 millimeter to 3 millimeters.

24. The compression device according to any one of claims 15 to 23, wherein the posterior housing comprises a cover element having a thickness of less than 5 millimeters, the cover element configured to rest against the flat posterior auricular surface.

25. The compression device according to any one of claims 15 to 24, wherein the at least one anterior magnet and the at least one posterior magnet are configured to generate a compressive pressure in a range of 30 mmHg to 200 mmHg when separated by ear tissue having a thickness in a range of 2 millimeters to 4 millimeters.

26. The compression device according to any one of claims 15 to 25, wherein the anterior compression assembly and the posterior assembly define a compression axis oriented perpendicular to an anatomical plane of the conchal bowl region.

27. The compression device according to any one of claims 15 to 26, wherein the posterior auricular surface comprises a flat posterior auricular surface.

28. A method of treating auricular hematoma, comprising:positioning an anterior compression assembly against an anterior surface of an ear at a location of the auricular hematoma, the anterior compression assembly including a moldable compression body and at least one anterior magnet;positioning a posterior magnetic assembly against a posterior surface of the ear opposite the anterior compression assembly, the posterior magnetic assembly including at least one posterior magnet having a magnetic polarity opposite to a magnetic polarity of the at least one anterior magnet;magnetically coupling the anterior compression assembly to the posterior magnetic assembly through ear tissue, whereby magnetic attraction between the at least one anterior magnetand the at least one posterior magnet applies compressive force across a cartilage-perichondrium interface of the ear;conforming the moldable compression body to contours of the ear at the location of the auricular hematoma; andmaintaining compressive engagement between the anterior compression assembly and the posterior magnetic assembly for a treatment duration sufficient to promote reattachment of perichondrium to underlying cartilage.

29. The method according to claim 28, wherein conforming the moldable compression body to contours of the ear comprises heating the moldable compression body to a softening temperature in a range of 45°C to 75°C prior to positioning the anterior compression assembly against the anterior surface of the ear.

30. The method according to claim 29, wherein the moldable compression body comprises ethylene-vinyl acetate having a vinyl acetate content in a range of 28% to 40%.

31. The method according to any one of claims 28 to 30, wherein the location of the auricular hematoma comprises at least one of a triangular fossa region and a conchal bowl region of the ear.

32. The method according to any one of claims 28 to 31, wherein the compressive force applied across the cartilage-perichondrium interface is in a range of 20 mmHg to 300 mmHg.

33. The method according to any one of claims 28 to 32, wherein the treatment duration is in a range of 3 days to 14 days.

34. The method according to any one of claims 28 to 33, further comprising draining the auricular hematoma prior to positioning the anterior compression assembly against the anterior surface of the ear.

35. The method according to any one of claims 28 to 34, wherein maintaining compressive engagement is performed without suturing through cartilage of the ear, whereby the method provides a non-invasive treatment alternative to bolster application.

Images