Abstract:
A nasal splint for effecting controlled support of the nasal pyramid, the splint, which can have a base portion of pyramid configuration, having a bridge portion and a pair of elongated wings on each side of the bridge portion extending laterally from the bridge portion thereof; an elastomeric device adjustably attachable on lateral edges of said wings to exert a force on said wings. The wings can also have at least one opening for fixedly positioning at least one compression head having a stud extending medially through the at least one opening. The base portion can be formed from a bendable frame laminated to a pliable membrane pad, the foam pad being disposed medially to the frame.

Description:
FIELD 
     The present products and methods relate to nasal splints, and in particular to nasal splint products, kits and methods that provide pressure points on the nasal pyramid of a human, which are selectable as to location and degree of compression. 
     BACKGROUND 
     Plastic surgery operations to the nose, i.e., rhinoplasty, are performed to treat nasal trauma, congenital nasal defects, cosmetic preferences, and the like. Rhinoplasty is the most frequently performed cosmetic surgical procedure in the United States. Most rhinoplasty and/or nasal reconstruction operations involve reshaping as well as strengthening a patient&#39;s nasal pyramid. A nasal pyramid includes both sides of the nose bridge at the nasal bone, upper lateral cartilage, and lower lateral cartilage sections. 
     Unfortunately, follow-up revision surgery is often necessary to correct post-operative nasal deviation after rhinoplasty. This is an obviously undesirable result due to the added emotional and physical trauma and added overall cost of the procedure. The post-operative deviation can result from repeated and unintended contact with the nose, such as sleeping postures that place biased forces on the nose, and the like. Deviation can also result from an inherent tendency for a nose to grow in the deviated direction. 
     One attempt to reduce post-operative nasal deviation is by applying a compressive force to the nasal pyramid. One compound splint sold under the trade name DENVER SPLINT by Shippert Enterprises, LTD of Centennial, Colo. provides a rigid base layer to follow the contour of the nose bridge. (See generally, U.S. Pat. No. 4,213,452 to Shippert). This type of splint provides little or no generalized compression, and is only used for about one week post-operatively as standard procedure. Also, rigid thermoplastic nasal splints, such as one sold under the trade name AQUAPLAST by Smith &amp; Nephew Rolyan, Inc. of Menomonee Falls, Wis., can provide limited stabilization and protection to a nasal pyramid, post-rhinoplasty. 
     Despite these attempts in the art to improve rhinoplasty outcomes, further advances are possible and desirable. 
     SUMMARY 
     Accordingly, provided herein are embodiments that relate to nasal splints, and in particular to nasal splint products, kits and methods that provide pressure points on the nasal pyramid of a human, which are selectable as to location and degree of compression. 
     In one embodiment, an adjustable nasal splint kit provides a custom fit using adjustable pads disposed on a frame having a plurality of position points. 
     One embodiment provides a nasal splint for effecting controlled support of the nasal pyramid, the splint, which can have a base portion of pyramid configuration, having a bridge portion and a pair of elongated wings on each side of the bridge portion extending laterally from the bridge portion thereof; an elastomeric device adjustably attachable on lateral edges of said wings to exert a force on said wings. The wings can also have at least one opening for fixedly positioning at least one compression head having a stud extending medially through the at least one opening. The base portion can be formed from a bendable frame laminated to a pliable membrane pad, the foam pad being disposed medially to the frame. The bendable frame can be composed of a material selected from the list consisting of metals, titanium, rubber, carbon fibers, wood, plastic, elastomers, composites, combinations thereof, and the like. Optional features can include a cap to cover the compression head stud. 
     In some embodiments, the at least one opening for fixedly positioning at least one compression head can have a slotted opening on the base portion of each wing; and the at least one compression head being mountable at any point along the slotted opening and fixedly and extensively variable through the at least one opening. Also, in some embodiments, the slotted opening can be oriented on a longitudinal axis the base portion of the at least one wing. Also, the at least one compression head can be fixedly and extensively variable through the at least one opening by a plurality of frangible annular rings along a shaft of the compression head stud having a diameter greater than the opening. As an alternate embodiment, the at least one compression head can be fixedly and extensively variable through the at least one opening by a helical ridge along a shaft of the compression head stud having a diameter greater than the opening. 
     In some embodiments, the bridge portion can be flexible along a longitudinal axis to reduce a lateral dimension the base portion up to about 20 mm. Also, the elastomeric device, such as a headband, can provide a force on said wings to provide a force of up to 2 newtons on the at least one compression head. 
     In another approach, a nasal splint for effecting controlled support of the nasal pyramid can have a base portion of pyramid configuration, having a bridge portion and at least one elongated wing on at least one side of the bridge portion ( 26 ) extending laterally from the bridge portion thereof; an elastomeric device adjustably attachable on lateral edges of the at least one wing to exert a force on the at least one wing; the at least one wing further having at least one opening for fixedly positioning at least one compression head having a stud extending medially through the at least one opening. In one embodiment, the force of the compression head can be configured to provide up to 35 percent displacement of the patient&#39;s nasal tissue medially towards the patient&#39;s facial midline. The elastomeric device can be adjustable to provide simultaneous displacement of nasal tissue on both sides of a patient&#39;s face by at least one compression head. The nasal splint can be configured so that the volume, location and percentage of nasal tissue displacement can be adjustable by varying the number, position, and extension of stud head  100  with respect to device frame  20 , and the force by the headband. A compressive force of the at least one compression head can be in the range of up to about 6 Newtons. 
     Other features will become more apparent to persons having ordinary skill in the art to which the package pertains and from the following description and claims. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The foregoing features, as well as other features, will become apparent with reference to the description and figures below, in which like numerals represent like elements, and in which: 
         FIG. 1  illustrates a perspective front view of an exemplary nasal splint of the present embodiments; 
         FIG. 2  illustrates a perspective rear view of an exemplary nasal splint of the present embodiments; 
         FIG. 3  illustrates an exploded perspective rear view of an exemplary nasal splint of the present embodiments; 
         FIG. 4  illustrates a perspective plan view of an exemplary nasal splint of the present embodiments in use; 
         FIG. 5  illustrates exemplary points on a nose to selectively apply compression using nasal splint of the present embodiments; 
         FIG. 6  illustrates a perspective side view of an exemplary frame for a nasal splint of the present embodiments; 
         FIG. 7  illustrates a perspective front view of an exemplary frame for a nasal splint of the present embodiments; 
         FIG. 8  illustrates a top view of an exemplary frame for a nasal splint of the present embodiments; 
         FIG. 9  illustrates a perspective view of an exemplary compression stud for a nasal splint of the present embodiments; 
         FIG. 10  illustrates a bottom view of an exemplary compression stud for a nasal splint of the present embodiments; 
         FIG. 11  illustrates a side view of an exemplary compression stud for a nasal splint of the present embodiments; 
         FIG. 12  illustrates a perspective view of an alternate exemplary compression stud for a nasal splint of the present embodiments; 
         FIG. 13  illustrates a perspective view of another alternate exemplary compression stud for a nasal splint of the present embodiments; 
         FIG. 14  illustrates an exploded perspective rear view of another exemplary nasal splint of the present embodiments; 
         FIG. 15  illustrates an exploded perspective rear view of another exemplary nasal splint of the present embodiments; 
         FIG. 16  illustrates a perspective rear view of another exemplary nasal splint of the present embodiments; 
         FIG. 17  illustrates a perspective front view of an exemplary nasal splint of the present embodiments according to another approach; 
         FIG. 18  illustrates a perspective front view of an exemplary nasal splint of the present having an optional stub cap; 
         FIG. 19  illustrates a perspective front view of an exemplary nasal splint of the present having an optional frame cap; and 
         FIGS. 20-22  illustrate perspective views of exemplary headband alternatives of the present embodiments. 
     
    
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS 
     Provided herein are embodiments that relate to nasal splints, and in particular to nasal splint products, kits and methods that provide at least one pressure point on the nasal pyramid of a human, which is variably positionable as to location and variable as to degree of compression. In use, the present embodiments can be configured to improve rhinoplasty and/or nasal reconstruction outcomes by reducing post-operative nasal deviation which can occur as nasal bones and tissues heal. The term ‘rhinoplasty’ is used herein to describe nasal surgical procedures. It is noted though that all the nasal surgeries, such as nasal reconstruction and the like, are included with the use of that term. 
     A physician can prescribe a customized compression configuration schedule using the present embodiments. For example, to aid in the understanding of how the present embodiments can be used, a multi-part schedule can be developed for each post-operative patient. Initially, this could include the present embodiments configured to provide a slightly progressive compression configuration to evaluate whether cartilage, bones, and the nasal pyramid/framework area are recovering correctly. Thereafter, a custom and more moderate nose-stabilizing method can be applied using the present nasal splint embodiment. This phase could last for several weeks and even up to one year. The physician/surgeon can evaluate and subsequently adjust the position and degree of compressive forces on the nose during follow-up appointments to minimize undesired deviation. 
     Generally, the present splint embodiments can provide a deformable/moldable frame to accommodate varying nasal profiles, while providing adjustable compressive forces to predetermined areas of a healing post-rhinoplastic nose. The magnitude and location of the compressive forces along the nasal profile can be adjusted as prescribed. Based on the knowledge of the procedure and the underlying nasal structure, the surgeon can apply a force such that the desired nasal deformation is achieved. Embodiments can include a frame that covers both sides of the nasal pyramid, though some embodiments cover only one side of the nasal pyramid. 
     The present splint, as described, would not require the use of an adhesive on the surface that contacts the skin, though use of an adhesive would not be prohibited either. In one approach, an adhesive could actually be used to provide a negative compressive force against the nasal pyramid (in other words the force on the skin is the reverse of the compressive force described herein using the pads and studs). In this instance, the adhesive could be applied only along the outer perimeter of the splint or internally at strategic locations (e.g., not on the screws/pads). The adhesive force would oppose the compressive force of to the screws/pads described herein; otherwise the splint will apply only uniform compression like DENVER splints. 
     The present nasal splint embodiments seek to address three preferable criteria of a customizable nasal splint, namely: to provide positionable compressive force, to provide variable intensity compressive force, and preferably to achieve these results without the use of an adhesive to the patient&#39;s skin. These criteria can be achieved using the nasal splint embodiments illustrated in the figures and the description below. Generally, as shown, the present nasal splints provide short-term and long-term treatments described above. Compressive inserts can be used immediately after surgery for more aggressive deviation prevention or treatment. And, more generalized pressure foam can be used for the remainder of the recovery period. Both compressive inserts and pressure foam can provide the desired adjustable compressive forces to the face. 
     Turning now to the figures, there is shown in  FIG. 5  a profile of a portion of a human face generally indicated at  50 . A nose  52  can have a multitude of areas  54 , where forces can be selectively applied to maintain an optimal shape of the nose as set by the physician/surgeon during the nasal surgery. It is noted that areas  54  are provided for ease of understanding the present embodiments and it is understood that there are infinite other areas of the nose can be selected to provide compressive forces and still be within the scope of the present nasal splint and kits. Further it is noted that the present embodiments can apply force to either or both sides of nose  52 . 
     An exemplary splint of the present embodiments is shown in use generally at  20  in  FIG. 4 . As shown, splint  20  is attached by a headband  28 . Head/neck band  28  can be positioned either above or below the patient&#39;s ears (not shown), though preferably below their ears. The general components of this embodiment can include a frame  80 . Frame  80  can be made from of metals, titanium, rubber, carbon fibers, wood, plastic, elastomers, composites, combinations thereof, and the like. Frame  80  can be bendable or formable about a bridge portion/frame  26  and a pair of wing portions  34  to cover the patient&#39;s nasal pyramid. 
     Headband  28  can be an elastic material and adjustable in length, and thus adjustable in the amount of compression by a hook and loop fastener, such as one sold under the trade name of VELCRO. For example,  FIG. 20  illustrates a headband  28   i  shows a hooks  118  and loops  114  fastener to attached first and second ends of headband  28   i . Position indicators  118  can be added to orient the patient as to the proper point of attachment of the first and second ends. Many other means of indicating desired attachment points of the headband  28  ends to the right tensioning position are possible within the scope of the present embodiments. As an alternate embodiment,  FIG. 21  provides a headband  28   ii  having a first strap with a plurality of holes  122  to provide attachment by at least one corresponding peg  124  on a second strap of headband  28   ii . In this embodiment, indicia  126  can be provided to assist a patient in orienting the fastening point of the two straps. Indicia can include letters, symbols, numbers, and the like. 
     The headband  28  can have enough elasticity to allow a user to set the position of the closure point, and then place on their head. As shown, headband  28  can attach to frame  26  by looping through the openings found at frame cut-outs  86  and  88 . Many other attachment configurations are possible within the scope of the present embodiments. Other headband embodiments can provide connections to the side and to the front including connection and adjustability at the frame  26  itself. For illustrative purposes, as shown in  FIG. 22 , headband  28   iii  attaches through the portion that loops through frame cut-outs  86  and  88 . 
     A more detailed view of an exemplary splint  20  embodiment is found in  FIGS. 1-3 . As shown, wing portions  34  of frame  80  can be laminated to a pliable pad  82  (“foam pad”). Foam pad  82  can be a closed cell or open cell foam laminated to the wing portion  34  by a bonding layer, such as a glue. Foam pad  82  and wing portions  34  have corresponding frame cut-out  86  and foam pad cut-out  88  for neck band attachment such as shown in  FIG. 4 . In the embodiment shown in  FIGS. 1-3 , a frame slot  90  is provided to slidably retain studs  84 . As described herein, studs  84  can be extended and held at various positions along the length of its shaft  98 . Stud shafts  98  extend through foam pad  82  by either a matching cutout, or as shown, as a foam pad slit  92 . It is also noted that while the slots are illustrated in the longitudinal orientation of the frame, that other slot orientations (e.g., lateral, diagonal, combinations, and the like) are possible. 
     The extension of stud shafts  98  can be retained through the use of annular rings  94  ( FIGS. 1-3 ) or a helical screw ( FIG. 12 ). As shown in  FIG. 2 , the stud shaft  98  terminates with a stud head  100 . Stud head  100  provides the surface for the splint to apply compressive force (force) on a users nasal pyramid.  FIGS. 9-13  shown additional exemplary stud configurations within the scope of the present embodiments. Studs  84  can be formed from a variety of flexible, resilient and/or deformable material. Exemplary materials can include plastics (such as an elastomer or thermal plastic), rubber, and the like. The material chosen should allow no more than about 20 percent of deformation as a result of the compressive force from headband  28 . 
       FIGS. 6-8  show alternate views of frame  80 . It is noted that in use, the neckband  28  can apply a force to reduce dimension  42  along the frame centerline  44 . The reduction in dimension  42  is patient dependent, but the device may be able to be reduced in dimension by up to 20 mms of the overall lateral dimension of the base frame. It is noted that the embodiments could still function with little or even no reduction in dimension  42  so long as a compressive force (or pressure or tensioning) against a patient nasal tissue is provided as shown in  FIG. 8  by direction arrows  102  is obtained against the patient&#39;s nose. The reduction in dimension  42  can be adjustable by the length and elasticity of headband  28 . This force is adjustable as described above. The compressive force applied by each head  100  of stud  84  on a user can be in the range of up to about 6 N (newtons). In one embodiment, stud head  100  to be applied to the nasal tissue can be round (shown), oval, ovoid and the like and have a diameter in the range of about 2 to 20 mms in diameter of the surface to be applied to the nasal tissue, and preferably about 8 to 12 mms in diameter. The ratio of elastic force and compression force can by in the range of up to about 1:1. 
     The amount of force applied by stud head  100  of stud  84  can be configured to be adjustable by varying the tension of headband  28  to apply a force sufficient to medially displace (or deform) the patient&#39;s nasal tissue(s) at rest up to 35 percent the distance to the patient&#39;s facial midline. For illustrative purposes,  FIG. 4  shows a patient&#39;s facial midline  108 . As tension is applied by headband  28 , stud head  100  applies force in direction  128  (irrespective of the angle from which the force is applied by stud head  100  to the nasal tissue) to the patient&#39;s nasal tissue displacing it medially from position  110  (the position of the nasal tissue with no force applied) to a position  112  medially to facial midline  108 . As stated, the present embodiments should be configured to allow adjustability of the headband to allow up to 35 percent displacement of the nasal tissue medially towards the patient&#39;s face line. This degree of displacement can occur simultaneously on both sides of a patient&#39;s face by at least one stud head  100 . Alternately, the volume, location and degree of nasal tissue displacement (or displacements) can be adjusted by varying the number, position, and extension of stud head  100  from the device frame  20 , in addition to the tension applied by the headband. 
     As shown in  FIG. 3 , a user can place any number of studs  84 , but at least one stud, along the length of slot  90  (and slit  92 ). One the position along the slot is determined, the user can continue to push against the stud head  100  until the desired amount of the extension of the head  100  from the from 80 is achieved. 
     Other approaches are possible within the scope of the present splint  20  embodiments and are shown in  FIGS. 14-16 . In one approach shown in exploded view in  FIG. 14 , nasal splint generally indicated at  20  has compression inserts  30 . As shown, nasal splint  20  has an exterior cover layer  22 . Cover layer  22  can be configured to match the skin tone of the user or have other textures or patterning to provide an aesthetic to the splint and otherwise cover a rigid, but deformable, base frame  18 . Cover layer  22  can be made from a variety of materials, such as one sold under the tradename LATEX adhesively attached to base frame  18  by placing an adhesive layer  58  on the side facing frame  18 . It is noted though that cover layer  22  can be made from a other of materials, such as hypoallergenic materials. Frame  18  is preferably a malleable material, such as an aluminum stamping, that can be rigid yet capable of being shaped or formed to the configuration of the nose profile of a user. Preferably frame  18  is made from Aluminum 6061. 
     As illustrated, frame  18  (and frame cover  22 ) can have a plurality of openings  46  that are configured to correspond to desired pressure points  54  on a nose, such as those shown in  FIG. 5 . Openings  46  are designed to receive a shaft  60  having at least one compression insert  30  as desired by a health care provider. As with studs  94  above, inserts  30  can be of varying thickness and firmness formed injection molded plastic inserts (or liquid crystal polymer inserts) with a deformable/compressible shaft  60  (facing externally) and a compression head  62  directed inwardly toward the user. As shown, shaft  60  can even provide a vertical void to allow for easier insertion into opening  46 . Preferably compression head  62  (like stud head  100 ) is flat and circular and preferably about 2 to 8 mm in diameter (range 2 mm to 18 mm) and preferably be about 2 mm to 3 (range 1 mm to 7 mm). Additionally, ribs/flanges as annular rings  64  can be added along the length of shaft  60  to provide variation of the extension of the insert  30  from frame  18 . In use, shaft  60  can be pushed through a desired opening  46  to the desired distance. 
     Additionally, nasal splint  20  can have a skin contact foam layer  36 . Foam layer  36  can preferably be made from a sheet of medical-grade foam with similar perimeter profile as frame  18  and covers head  62 . A peelable adhesive layer  66  can be used to hold foam layer  36  to frame  18 . Foam layer  36  can provide an interface that is comfortable for facial skin around the nose and diffuse the transmitted compressive force applied by inserts  30 . 
     An elastic and/or adjustable headband  28  wrapped around the head/neck of a user can be used to provide the compressive force to the inserts  30 . Headband  28  can optionally have a terry cloth covering and connect to the frame  18  via headband slots  56 . Also, an optional nose clip  40  can be attached to frame  18  through nose clip slot  68 . Nose clip  40  can be an injection molded part (or liquid crystal polymer part) and have nose pads  38  to gently pinch the nose bridge of a user. Nose clip  40  provides a means to fix and adjust the vertical position of nasal splint  20 . 
       FIG. 15  provides another embodiment of an exemplary nasal splint  20 . In this embodiment, nasal splint  20   i  has a frame cover  22  as described above attached to the base frame by an adhesive. A base frame  18   i  can be a custom-stamped, flexible aluminum structural frame of the device that can is malleable accommodate varying nasal profiles in different patients and can feature a pair of extensions  70  (preferably PTFE/parylene-coated extensions) positioned so that they can be bent inward at the entrance of a user&#39;s nostrils to hold the position of splint  18   i  in place. In alternate embodiments, a headband  28 , such as shown in  FIG. 4  can be used. Attached on frame  18  on the opposite side of the frame cover  22  is one side of a fastening means, such as a loop side  32  of a hook-and-loop fastener, such as one sold under the trade name VELCRO. The second side of the fastening means, such as the hook side  34  of a hook-and-loop fastener can be disposed beneath loop side  32  and be used to attach the skin contact foam layer bottom  36 . It is noted though that in alternate embodiments fastening means  32  and  34  can be one adhesive layer and preferably a peelable adhesive layer. 
     Captured between fastening layers  32  and  34  can be pressure foam pads  72 . Pads  72  can be dense circular foam shapes of varying thicknesses which can be adhered onto the Soft Velcro Layer—backside of Pressure Foam Pads to be Velcro (hook side)—or Foam Layer Bottom—backside of Pressure Foam Pads to be layered with adhesive. As with compression inserts  30 , pads  72  can apply pressure on the nasal profile. The number, thickness, and density of pads  72  vary depending on the patient and are determined by the patient&#39;s health care provider. In this instance, pads  72  can be placed anywhere on the frame  18 . 
     Additionally, optional nose pads  74  can be added internally on foam layer  36  to provide a stable resting point for the splint  20   i  and to maintain its vertical orientation. Nose Pads  74  can be made from a variety of materials, such as silicone molded oval structures much like those used on reading glasses. 
     In another approach shown in  FIG. 16 , a nasal splint is shown generally as  20   ii . As illustrated, nasal splint  20   ii  is bent down a centerline  44  to accommodate the shape of a user&#39;s nose. Tabs  48  can be used to secure the frame to the patient with the tabs at the base used to extend into the patient&#39;s nostrils and the tabs at the top to pinch the nasal bone. 
       FIG. 17  illustrates a perspective front view of an exemplary nasal splint of the present embodiments according to another approach  20   ii . In this approach, base frame  18   ii  only has one wing portion  34   ii  to apply to only one side of the nasal pyramid. It is noted that the base frame as illustrated is configured for the right-hand side of the nasal pyramid. A reciprocal left-hand base frame (not shown) can also be applied in applications needing compressive force on the left-hand side of the nasal pyramid. 
       FIG. 18  illustrates a perspective front view of an exemplary nasal splint of the present having an optional stub cap. As shown, cap  106  can cover the stud portion  84  of the compression head.  FIG. 19  illustrates a perspective front view of an exemplary nasal splint of the present having an optional frame cap. In this instance, cap  104  covers the base frame  18 . Cap  104  can be any type of thermoplastic, polypropylene, metal, rubber, wood, composite, and combinations thereof; and preferably a thermoplastic. 
     In use, nasal splint  20  can be configured and applied to a patient by a health care professional directly after a rhinoplasty procedure, and nasal splint  20   i  can be applied in the health care provider&#39;s office during a follow up visit. No additional or specialized equipment or tools are necessary for the physician to prepare the device. During preparation, the angle of the base frame can be formed to match the profile of the patient&#39;s nose. In addition, the position and degree of the compression inserts or pressure foam pads can be adjusted. The present design provides for fast and efficient configuration while providing customization than is currently known in the art. 
     A patient can wear nasal splint while at rest, e.g., sleeping. The patient is thus provided with, on average, between about 5 hours up to 24 hours of treatment daily. The assumption is that after daily treatment for up to about a year, the patient&#39;s nasal profile should remain as straight as the rhinoplasty procedure had intended it to be. Additionally, since the patient can use the splints in a home setting, the level of emotional trauma and discomfort can be reduced because he or she does not have to wear the device during all parts of their daily life. Adjustable headbands can also be varied to increase the degree of compression. 
     Optional embodiments can also be included in the present nasal splint configuration to provide even further levels of customization. The health care provider may be able to calculate the configuration of the nasal splint and have a device to produce a custom non-adjustable piece. 
     Although the present embodiments use an adjustable headband and inserts, there are many ways to offer external compressive forces. For example, some embodiments can provide external compression by other types of fluid and/or mechanical means. External compression can include viscous injection, adjustable air/fluid bladders (which can be compartmentalized into a plurality of bladders) with injection ports, stretchable pouches, leveling screws, tightening screws, spring-screws, collapsible screws, 90° tube opening, buckling domes, and nitinol-mesh skeletons. 
     While preferred embodiments have been described in detail, variations and modifications can be effected within the scope of the present embodiments.