Patent ID: 12251329

DETAILED DESCRIPTION OF THE INVENTION

The present invention is not limited to the illustrated or described embodiments as these are intended only to assist the reader in understanding the subject matter of the invention. The illustrated embodiments are examples of forms of the invention that are either depicted, taught, enabled, described, illustrated and claimed here. The illustrations and description cover all structures and methods which embody similar functionality. One of ordinary skill in the art will appreciate that features, devices, elements, members or components thereof, methods, processes or techniques may be applied, interchanged, eliminated in whole or part, or combined from one embodiment to another.

As illustrated in the various embodiments, the nasal splint device10is identified generally by reference numeral10in all the figures. In each of the figures illustrated, the nasal splint10comprises an outer layer12serving as a semi-rigid frame over an inner layer14that is flexible, soft, and/or malleable and configured to sit against or contour along a patient's nose. The nasal splint10adheres to and flexed across the bridge of the nose15, illustrated in the drawings in broken lines as a portion of a human face. The inner layer14aserves as a base layer designed to act as a buffer in engaging the patient's skin.

It should be recognized that the various members or components of the nasal splint10, materials, layers or regions may be of differing size, area, thickness, length or shape than that illustrated or described while still remaining within the purview and scope of the present invention. The nasal splint10may be constructed with portions of one or more nasal splint layers to engage nasal outer wall tissues. When engaged on the nose of a wearer, preferably no portion of a layer of the nasal splint10extends substantially over a skin surface area beyond the surface areas associated with the nasal passages as described here. When the nasal splint10is flexed across the nose, separations or vertical protrusions within the nasal splint10change the angle, in part, of spring biasing forces, as described here, transforming the forces and imparting them, at least in part, to tissue engaging surface areas.

Referring now toFIGS.1and2, in accordance with a first embodiment, the nasal splint device10ais positioned over a patient's nose15(shown in broken lines) such that the outer layer12aserves as a semi-rigid or resilient frame over an inner layer14athat is flexible, soft, and/or malleable and configured to sit against or contour along the person's nose, the outer layer12acompressible by a tubular spring mechanism16positioned over the top portion of the outer layer12aand configured to vary the pressure applied on the nose15. The outer layer12acompressible by the tubular spring mechanism16including two identical compression springs18, positioned between two opposing flanges20and22of the outer layer12are configured to vary the pressure applied on the nose. The two substantially identical compressing springs18are parallel to each other and designed to flank either side of the top of the patient's nose15. The two substantially identical compression springs18are designed to run along the length of a patient's nose15, biased to vary the pressure on the two opposing flanges20and22. The two opposing flanges20and22gently keep the nose15intact and in position to facilitate healing as the patent recovers.

One type of material that may be used for the inner or base layer14aand cover or outer layer12ais from a group of widely available flexible nonwoven synthetic fabrics that allow the skin on user nose11to exchange gases with the atmosphere and to maximize comfort of the nasal splint10thereon. Alternatively, any suitable fabric or plastic film may be used.

In some embodiments, a continuous pressure sensitive adhesive substance, biocompatible with external human tissue, may be disposed on at least one flat surface side of said material which is the adhesive side, opposite the non-adhesive side. The non-adhesive side is typically opposite the skin engaging side. A protective layer of continuous release paper liner may cover the adhesive. The materials are typically available in continuous rolls wound in a machine direction (MD) or warp, which is perpendicular to the cross direction (XD) or fill, of the fabric. The inner or base layer14aand outer or cover layer12aof nasal splint10may be fabricated parallel to either the warp or the fill of the fabrics. In one embodiment, the outer or resilient layer12ais a biaxially oriented polyester resin (PET). PET has suitable spring biasing properties both MD and XD, and is widely available under trade names such as Mylar® and Melinex® in a variety of standard thickness including 0.005″, 0.007″, and 0.010″.

In accordance with a second embodiment illustrated inFIGS.3and4, the nasal splint device10bmay be positioned over a person's nose such that an outer layer12bserves as a semi-rigid frame over an inner layer14bthat is flexible, soft, and/or malleable and configured to sit against or contour along the person's nose, the outer layer compressible by a flat spring mechanism24positioned over the outer layer12band configured to vary the pressure applied on the nose15. The second embodiment may be constructed from similar materials as those described for embodiment one. The flat spring mechanism24is shaped with a scalloped edge on either side, designed and biased to gently vary the pressure on the outer layer12bas it covers the nose15.

In accordance with a third embodiment illustrated inFIGS.5and6, the nasal splint10cis adapted to be positioned over a person's nose such that it's outer layer12cserves as a semi-rigid frame over an inner layer14cthat is flexible, soft, and/or malleable and configured to sit against or contour along the patient's nose, the outer layer12cwith two projecting flanges24(on either side) held by two springs26aand26bbetween them, configured to move the projecting flanges24to vary the pressure applied on the nose. The two springs26aand26bare coiled springs held substantially in place by an eye at either end with a nut. Applying a slight force on the protecting flanges24to compress the distance between the projecting flanges24can help position the nasal splint10cover a patient's nose. The third embodiment may be constructed from similar materials as those described for embodiments one and two.

In accordance with a fourth embodiment, the nasal splint10dis positioned over a patient's nose such that an outer layer12dserves as a semi-rigid frame over an inner layer14dthat is flexible, soft, and/or malleable and configured to sit against or contour along the patient's nose, the outer layer12dhaving a crimped surface and assembly2628(at either end) configured to vary the pressure applied on a patient's nose. The crimped surface and assembly28create the biased forces to vary the pressure by the nasal splint10on the nose15. The fourth embodiment may be constructed from similar materials as those described for embodiments one, two, and three.

In accordance with a fifth embodiment, the nasal splint device10eis adapted to be positioned over a person's nose such that it's outer layer12eserves as a semi-rigid frame over an inner layer14ethat is flexible, soft, and/or malleable and configured to sit against or contour along a patient's nose, the outer layer12ewith two projecting flanges30(on either side) held by a knurled-nut mechanism32between them, configured to move the projecting flanges30to vary the pressure applied on the nose. The knurled-nut mechanism32comprises a nut34and a grooved pin36over which the nut34rolls. Moving the nut34tightens or releases the pressure on the projecting flanges30by compressing or widening the distance between the projecting flanges30. The fourth embodiment may be constructed from similar materials as those described for embodiments one, two, three, and four.

The width, length and peripheral outline or edges of the various embodiments of the nasal splint10may be defined by the base or inner layer (e.g.,14a), cover or outer layer (e.g.,12a), or a combination of any two or more layers or portions thereof. The base or inner layer14aand cover or outer layer12aof nasal splint10may have like or dissimilar dimensions or peripheral edges, in whole or in part, compared to each other. Their respective peripheral shapes may be uniform or non-uniform, and may also be of like or dissimilar size or scale. Portions of any layer may define a horizontal region of the nasal splint10or a portion thereof. Furthermore, the base or inner layer (e.g.,14a) and cover or outer layer12aof nasal splint10may be interchanged in portions. The base or inner layer (e.g.,14a) and cover or resilient layer (e.g.,12a) may have identical peripheral edges, and thus may be formed as a single unit. Portions of one or both flat surfaces of any layer, member or component thereof, may overlap portions of any flat surface of another layer. Preferably, however, the base or inner layer (e.g.,14a) layer acts as a buffer in engaging the user's skin, as described here, and portions of one or more nasal splint layers may engage nasal outer wall tissues simultaneously. When engaged on the nose15of a wearer, preferably no portion of a layer extends substantially over a skin surface area beyond those surface areas associated with the nasal passages as described here.

Nasal splints10may be typically die cut from a continuous laminate of material layers. However, nasal splint layers, members or components thereof, material separations or horizontal regions may be formed or die cut, in whole or part, from one or more of continuous materials before, or during, assembly of the material laminate from which finished nasal splint10are die cut. In fabricating nasal splints10, end regions and projections are preferably formed as mirror images of each other. However, asymmetric or non-identical end region configurations have the advantage of providing disparate forces if required.

The nasal splint10is configured with the outer and resilient layer (e.g.,12a), which has resilient properties provided through its resilient layer and is configured to provide suitable spring return biasing force as described here. Overall spring biasing force is generally determined by the width, length, and thickness of at least one resilient member or the resilient layer as a whole from its constituent member(s) and/or components. Resilient member preferably has an adhesive substance disposed on at least a portion of at least one of two opposite flat surface sides for engaging or laminating it to other layers, members or components of the nasal splint10or for engaging the skin surface of the nose15. Resilient member has opposite terminal ends that may conform to at least portions of the lateral end edges of the outer layer of the nasal splint10. The nasal splint10includes means to direct its resilient properties. The means may comprise configuration of, or modification to, the resilient layer or the material from which the resilient layer is formed. The configuration or modification may be made either in the course of forming the inner or resilient layer, or may be made to the outer or resilient layer material separately, or at the time the material is assembled into the continuous material laminate from which nasal splint10is die cut (i.e., at the time the vertical laminate of nasal splint10is formed). The configuration or modification may include cuts, notches, openings, or the like formed in the outer resilient layer material as required; or by varying the finished dimensions of the resilient member or a component thereof, such as by forming a gradiently-tapered width; or by peripheral shape of the resilient member, such as by extensions or divergent spring finger components extending outward from its longitudinal extent; or by more than one resilient member, each member contributing a portion of the total spring biasing force. Having divergent spring fingers or multiple resilient members may increase the effective surface area subject to resilient layer spring biasing forces by spreading those forces to a greater, primarily lateral, surface area of nasal splint10.

The disclosed embodiments of the nasal splint10may be constructed by a 3D printing process or additive manufacturing, which is the process for building a three-dimensional object from a computer-aided design (CAD) model, by successively adding material layer by layer, unlike conventional machining, casting and forging processes, where material is removed from a stock item (subtractive manufacturing) or poured into a mold and shaped by means of dies, presses and harmers. 3D printing processes cover a variety of processes by which material is joined or solidified under computer control to create the various embodiments of the nasal splint10, with material being added together (such as liquid molecules or powder grains being fused together, typically layer by layer. The precision accomplished by these processes have made them viable as industrial-production technology for products. One of the key advantages of using these processes is the ability to produce the shapes and geometrics of the various embodiments.

The illustrations depicted here may be used to create a 3D model or CAD file to initiate the process of manufacture. The digital 3D-model is saved in STL (stereolithography file) format and is then sent to a 3D printer. The 3D printer prints the design layer by layer to form a real object. There are several 3D printing technologies. The main differences are how layers are built to create parts. 3D printing technologies include SLS (selective laser sintering), FDM (fusion deposition modeling) and SLA (stereolithography). Selective laser sintering (SLS) and fused deposition modeling (FDM) use melted or softened materials to produce layers. The selective laser sintering (SLS) process melts fine powders, bit by bit, into 3D shapes. Fused deposition modeling printers use a thermoplastic filament, which is heated to its melting point and then extruded, layer by layer, to create the nasal splint10. The materials that may be used in this process to create the nasal splint10include basic material ABS, such as Acrylonitrile Butadiene Styrene, polyamide, polycarbonate, polyethylene, polypropylene. Many different materials may be used for 3D printing, such as ABS plastic, PLA, polyamide (nylon), glass filled polyamide, stereolithography materials (epoxy resins), silver, titanium, steel, wax, photopolymers and polycarbonate.

Models may be created by using software such as Google SketchUp, to draw edges and faces and using the push/pull tool to extrude any flat surface into a 3D form. Alternatively, the software 3Dtin may be used to draw directly from a browser. OpenSCAD is another software that may be used, which focuses on the CAD aspects. Tinkercad is another quick way to create designs, with only three basic tools that may be used to create the various embodiments. Once the model is created, the STL file may be downloaded and the 3D print process started. Alternatively, commercial software such as CAD software AutoCAD and Pro Engineer and software packages Rhino, Maya, and SolidWorks may be used to design 3D models.

The foregoing descriptions and illustrations are intended to reveal the scope and spirit of the present invention and should not be interpreted as limiting, but rather as illustrative of the inventive concepts and techniques thereof. One of ordinary skill in the art to which the present invention is directed will appreciate that insubstantial changes, modifications and alterations of the present disclosure may be made and each such insubstantial change, modification and alteration are intended to be fully covered hereby.