Patent Publication Number: US-2021169416-A1

Title: Slip-Resistance Patch for Oral Devices

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims priority to U.S. Provisional patent Application Ser. No. 62/936,098, filed Nov. 15, 2019, which is hereby incorporated by reference in its entirety. 
    
    
     FIELD 
     The present disclosure generally relates to a slip-resistance patch for oral devices that can maintain contact with a surface within an oral cavity. 
     BACKGROUND 
     Embodiments of the present disclosure generally relate to oral devices positioned within an oral cavity. The oral cavity commonly refers to a human mouth and all parts of the month such as lips, a tongue, teeth, a mouth roof, and a mouth floor. Oral devices are used for a number of applications that can include, but are not limited to, evaluative, diagnostic, therapeutic, and assistive applications. These devices are designed to be placed inside the oral cavity or in contact with at least portion of the oral cavity. Oral devices in the present art, are often made out of materials that are antibacterial, and depending upon the application, are hard structures, durable, resilient, or sturdy. Familiar examples can include plastics or silicon rubbers. When these materials are placed in an oral cavity, which is a salivated and wet environment, issues and challenges arise if the oral device is not fixated, secured, or otherwise anchored in an intended or optimal position. Without having the oral device secured, the oral device often slips from the intended position, hindering the oral device&#39;s ability to be properly used for its intended purpose or application. For example, an oral device used for assessing lingual function, such as tongue strength and tongue endurance, is an Iowa Oral Performance Instrument (IOPI). The IOPI is a smooth plastic, air-filled pressure lingual bulb, commonly known as a tongue bulb, which is placed in a standardized position on a patient&#39;s tongue within an oral cavity of the patient. The standardized position is 10-mm from a distal tip of the tongue of the patient for anterior tongue performance measures or 10-mm anterior to the patient&#39;s circumvallate papillae for posterior tongue performance measures. The IOPI has been found to have issues regarding slippage from the standardized position, which reduces precision and reliability of measurements recorded during the assessment. Therein, this creates concern to those in the art that measurements from oral devices are inconsistent, unreliable, and can lead to an increased risk of inaccurately evaluating, diagnosing, rehabilitating, and/or preventing lingual disorders, in addition to potentially imposing on one&#39;s quality of life. In general, tongue muscle performance has shown to decline as an individual ages, causing the individual&#39;s risk of an orofacial myofunctional disorder such as dysphagia and sleep apnea to increase. With use of therapeutic work for lingual function, tongue muscle performance can be restored; however, many insurance companies have required an assessment of lingual function, typically by the IOPI assessment, prior to assisting in cost associated with therapeutic work to validate that the work is necessary. Therefore, a reliable and objective assessment of lingual function is important because without a healthy tongue strength and endurance, the individual may have difficultly performing daily functional tasks such as swallowing, articulation, and maintaining an open upper airway. Therefore, there is a need for a simple and cost-effective solution to reduce oral device slippage from its intended position. 
     BRIEF SUMMARY 
     In one aspect, a slip-resistant patch for a tongue bulb comprises a perimeter portion. The perimeter portion defines a shape and size of the slip-resistant patch. A planar body is defined by the perimeter portion of the slip-resistant patch. The planar body is configured to contour to a surface of the tongue bulb. The planar body comprises a first major surface and an opposing second major surface. The first major surface comprises a textured material and the second major surface comprises an adhesive material. The textured material is configured to be positioned on a surface of an oral cavity and maintain position on the surface of the oral cavity throughout lingual movement within the oral cavity. The adhesive material is of a pressure sensitive material and configured to adhere to the surface of the tongue bulb. 
     In another aspect, a method to reduce slippage of a tongue bulb comprises providing at least one slip-resistant patch including a textured material and an adhesive material. The textured material comprises a textured surface and the adhesive material comprises an adhesive surface on an opposing face of the patch. The adhesive material is at least a portion of a pressure sensitive material. The adhesive surface is adhered to at least one surface of the tongue bulb, creating a texturized tongue bulb. The texturized tongue bulb is placed in contact with at least one surface of a patient&#39;s oral cavity. 
     Other aspects and features will be apparent hereinafter. 
    
    
     
       BRIEF DESCRIPTION OF DRAWINGS 
       For a better understanding of the nature and objects of the disclosure, reference should be made to the following detailed description taken in conjunction with the accompanying drawings, in which: 
         FIG. 1  is an illustration of a slip-resistant patch on a tongue bulb of an Iowa Oral Performance Instrument, forming a texturized oral device. 
         FIG. 2  is an illustration of the texturized oral device positioned within a patient&#39;s oral cavity. 
         FIG. 3  is an illustration of a top view and side view of the slip-resistant patch. 
         FIG. 4  is an alternative embodiment of the slip-resistant patch. 
         FIG. 5  is an illustration of the texturized oral device wherein the slip resistant patch further includes dead-end tabs. 
         FIG. 6  is an illustration of a further alternative embodiment of the slip-resistant patch. 
         FIG. 7  is a schematic illustration of a method to reduce slippage of a tongue bulb. 
     
    
    
     Reference is made in the following detailed description of preferred embodiments to accompanying drawings, which form a part hereof, wherein like numerals may designate like parts throughout that are corresponding and/or analogous. It will be appreciated that the figures have not necessarily been drawn to scale, such as for simplicity and/or clarity of illustration. For example, dimensions of some aspects may be exaggerated relative to others. Further, it is to be understood that other embodiments may be utilized. Furthermore, structural and/or other changes may be made without departing from claimed subject matter. References throughout this specification to “claimed subject matter” refer to subject matter intended to be covered by one or more claims, or any portion thereof, and are not necessarily intended to refer to a complete claim set, to a particular combination of claim sets (e.g., method claims, apparatus claims, etc.), or to a particular claim. 
     DETAILED DESCRIPTION 
     The present disclosure provides a slip-resistant patch  10  that is a cost-effective for retrofitting and modifying an existing oral device  12  to ensure the existing oral device can maintain in an intended position  14  or placement inside a patient&#39;s oral cavity, as best shown in  FIGS. 1-2 . The resulting combination of the slip-resistant patch  10  adhering to a surface of the existing oral device  12  creates a texturized oral device. For example, as shown in  FIG. 1 , a slip-resistant patch  10  can be designed for an existing oral device  12  such as, but not limiting to, a tongue bulb  16  of an Iowa Oral Performance Instrument (IOPI) for a purpose of evaluating a patient for tongue strength and endurance. The slip-resistant patch  10  adheres to a surface of the tongue bulb  16  and provides slip-resistant contact with a surface of a patient&#39;s oral cavity, such as but not limiting to, the patient&#39;s tongue  18 . The slip-resistant patch  10  allows additional control of the tongue bulb  16  during an evaluation. The additional control reduces or minimizes slippage about the tongue during the evaluation by maintaining placement or positioning of the tongue bulb  16  when placed at the intended position  14  on the tongue  18  such that the tongue can perform lingual movement and a static hold while the tongue bulb maintains generally at the intended position, as best shown in  FIG. 2 . Based off the lingual movement and the static hold, the IOPI measures an amount of pressure (kPa) the tongue  18  produces and maintains on the tongue bulb  16  for correlating to tongue strength and endurance, respectively. By stabilizing the tongue bulb  16  at the intended position  14 , reliability of the amount of pressure produced, indicating lingual function, during evaluation increases. Oral assessments of tongue strength and endurance are performed in both anterior and posterior regions of the tongue for identifying the patient&#39;s risk of orofacial myofunctional disorders such as dysphagia and sleep apnea. As one with skill in the art would understand, the intended position  14  is generally 10-mm from a distal tip of the tongue  18  of the patient for anterior tongue performance and generally 10-mm anterior to the patient&#39;s circumvallate papillae for posterior tongue performance. 
     As shown in  FIG. 3 , in the preferred embodiment of the present disclosure, a slip-resistant patch  10  comprises a substantially planar body  20 , a perimeter portion  22 , a textured material  24 , and an adhesive material  26 . The planar body  20  is defined by the perimeter portion  22 , a first major surface  28 , and an opposing second major surface  30 . As shown, the first major surface  28  of the slip-resistant patch  10  includes the textured material  24  while the other second major surface  30  includes the adhesive material  26 . The first major surface  28  and the second major surface  30  can adjoin by, for example but not limiting to, an adhesive layer formed across a backside  32  of the textured material  24  or a backside  34  of the adhesive material  26  such that the backsides affix. The adhesive layer can be any adhesive with an ability to securely adhere the backside  32  of the textured material  24  to the backside  34  of the adhesive material  26  and maintain adhesion when the slip-resistant patch  10  is within an oral cavity. 
     The perimeter portion  22  of the slip-resistant patch  10  defines geometry or shape of the slip-resistant patch, as best shown in  FIGS. 3-4 . The shape of the slip-resistant patch  10  is configured to be representative of a surface area on the existing oral device  12  to which the slip-resistant patch is to be applied, and can therefore have a plurality of mixed geometries such as a portion or combination of circular, oblong, square, rectangular, and pentagonal, hexagonal shapes. As can be appreciated, the size of the slip-resistant patch  10  can vary significantly as the size and shape is dependent on the surface area of the existing oral device  12  to which the slip-resistant patch is to be applied. In one or more aspects, the slip-resistant patch  10  is generally sized and shaped to cover at least half of at least one surface of the existing oral device in contact with an oral cavity, as best shown in  FIG. 1 . As one will skill in the art would appreciate, the slip-resistant patch  10  is meant to reduce slippage and therefore can be applied to any surface of an oral device in contact with a surface of an oral cavity. The slip-resistant patch  10  can be applied to a at least one surface of a patient&#39;s oral cavity, for example but not limiting to, a tongue, lips, a hard palate, cheeks, gums, teeth, a month roof, and a mouth floor. In following aspect, at least one texturized surface of the textured material  24  is in contact with at least one surface of the patient&#39;s oral cavity, as shown in  FIG. 2 . The shape of the slip-resistant patch  10  can further represent a surface area of the surface of the oral cavity. For example, the shape of the slip-resistant patch  10  can be sized and shaped to fit the underlying oral device, such as the tongue bulb  16 , and/or can be configured to fit in the patient&#39;s mouth adjacent the patient&#39;s tongue (e.g. generally elongated body with a rectangular shape at one end and rounded at the other end), as best shown in  FIG. 3 . 
     The textured material  24 , as best shown in  FIGS. 1-3 , is used to reduce the slippage of the tongue bulb  16  when inside an oral cavity, ensuring and maintaining placement at the intended position  14 . Therefore, the textured material  24  can be any material with enough surface texture to reduce slippage, particularly as in the preferred embodiment when placed in contact with the patient&#39;s tongue  18 , as shown in  FIG. 2 . In addition, the textured material  24  provides a non-abrasive surface during contact, making the material biocompatible. Preferably, a material selected for the textured material  24  is textured and non-abrasive so that the slip-resistant patch  10  does not result in any non-biocompatible effects to a patient or their oral cavity, including irritate, damage, harm, injure, hurt, infect, or wound. Further, in the preferred embodiment, the textured material  24  is porous and has minimal absorbency to avoid collecting and retaining too much saliva from the patient&#39;s mouth while within the oral cavity. In one embodiment, the textured surface comprises at least one material selected from fabric, cloth, and/or fiber. Woven fabrics and nonwoven fabrics made of thermoplastic elastomers are known in the art and can be used within the scope of the present disclosure, including for example, polystyrene-type elastomers such as a styrene-isoprenestyrene type block copolymer and hydrogenated block copolymers hydrogenating said block copolymer, polyurethanes, polyesters and polyolefins such as polyethylene, as disclosed. Natural material fibers, fabrics, or cloths can also be used, such as cotton, cellulose, and the like. Further, thin-film materials can be used, such as medical tapes, so long as they have adequate textured surfaces. The materials can be of synthetic or natural origins, or any combination of the listed materials thereof. In one or more embodiments, the slip-resistant patch  10  comprises a substantially planar fabric, cloth, or fiber woven or nonwoven web or mat (or thin film) and a layer of adhesive adjacent at least one major surface of the web or mat (or thin film), such that the texture of the fabric, cloth, or fiber of the first major surface  28  corresponds to the textured material  24  of the slip-resistant patch. 
     As best shown in  FIGS. 1 and 3 , the adhesive material  26  is configured to temporarily adhere to at least one surface of an existing oral device  12 , for example the tongue bulb  16 , after removing a temporary film (not shown) from an adhesive surface of the adhesive material. As one would understand, a removable temporary film can be provided to cover the adhesive surface to prevent the adhesive surface from adhering to any unwanted substrates. In the preferred embodiment, the adhesive material  26  can be any pressure sensitive adhesive with hydrophobic/waterproof properties such as acrylates (e.g., methacrylates and epoxy diacrylates). As one would understand, alternative adhesives can be used in the scope of the present disclosure. Further, in order to separate the adhesive surface from the surface of an existing oral device  12 , such as the tongue bulb  16 , the slip-resistant patch  10  can include dead-end tabs  36  that can extend from a portion of the planar body  20  such that the dead-end tabs provide leverage for peeling the slip-resistant patch from the existing oral device, as shown in  FIG. 5 . 
     In alternative embodiments of the present disclosure, the slip-resistant patch  10  can be in a pouch-like patch, as shown in  FIG. 6 , or alternatively a sleeve-like patch (not shown), that can allow the existing oral device  12  to slide into a receiving area  38  of a pouch. The adhesive material  26  can be on at least one interior surface of the slip-resistant patch  10  while the textured material  24  is on at least one external surface of the slip-resistant patch such that the adhesive material affixes the existing oral device  12  within the pouch of the slip-resistant patch  10  and the textured material contacts a surface within an oral cavity. In this embodiment, a portion of the existing oral device  12 , is encompassed by the slip-resistant patch  10 . One would appreciate that an opening of a sleeve or the pouch of the slip-resistant patch  10  can be configured to allow the existing oral device  12  to be inserted into the receiving area  38  without contacting an adhesive surface of the adhesive material  26 . Once the surface of the existing oral device  12  is fully inserted through the receiving area  38 , the adhesive surface of the slip-resistant patch  10  can be adhered to the surface of the existing oral device by contact with the adhesive material  26 . 
     Referring to  FIG. 7 , a method  100  to reduce slippage of an existing oral device  12  will now be briefly described. The method  100  comprises a step  102  of providing a slip-resistant patch  10  that includes a textured material  24 , an adhesive material  26 , and a temporary film covering an adhesive surface of the adhesive material. Further, step  104  includes removing the temporary film from the adhesive surface and temporarily adhering the adhesive surface to at least one surface of an existing oral device  12 , creating a texturized oral device. In more detail, the slip-resistant patch  10  is positioned with the adhesive surface adjacent the surface of the existing oral device  12 , such that the slip-resistant patch covers at least a portion of the surface and now outwardly presents a textured surface of the textured material  24  for contacting with at least a portion of the patient&#39;s oral cavity when the texturized oral device is positioned within the oral cavity. Step  106  involves placing the texturized oral device in contact with a surface of a patients&#39; oral cavity by placing the textured surface in contact with the surface of the patients&#39; oral cavity. Step  108  includes preforming an original application of the existing oral device  12 , for example measuring tongue muscle performance, and the like. The method  100  can further include Step  110  of removing the texturized oral device from the patient&#39;s oral cavity by peeling away the slip-resistant patch  10  from the existing oral device. Peeling away the slip-resistant patch  10  from the existing oral device  12  can be accomplished with at least one dead-end tab  36  extending from a portion of a planar body  20  of the slip-resistant patch  10 . In a general aspect of the present disclosure, the method can further include step  112  of sterilizing the slip-resistant patch  10  such that the slip-resistant patch is free of contaminates that can elicit at least one undesirable response in an oral cavity prior to placing in contact a surface of the existing oral device and a surface of a patients&#39; oral cavity. Undesirable responses can include toxic, irritating, distasteful, inflammatory, harmful, or lethal effects, which would result in a product that is not biocompatible. Further in order to prevent undesirable responses an unused slip-resistant patch  10  is discarded after each use and a fresh slip-resistant patch is used for a new patient. 
     In the present disclosure the term ‘slippage’ is used to describe the movement of an oral device within an oral cavity, such as sliding around on the patient&#39;s tongue. Further, ‘slippage’ is primarily useful in characterizing unwanted or undesirable movement of the oral device within the oral cavity. Therefore, slippage of an oral device is movement that leads to inability, difficulty, or hindrance in using an oral device for an intended purpose or application. Further, an existing oral device  12 , as best shown in  FIG. 1 , can alternatively be an oral device used for a variety of applications, including but not limiting to evaluation, diagnostic, therapeutic, preventative, rehabilitation, or assistive application within an oral cavity. The existing oral device  12  can be useful and beneficial across several clinical based fields, such as speech pathology, respiratory therapy, orofacial myofunctional therapy, dentistry, and orthodontics, along with research based fields, such as neuromuscular sciences and disorders, exercise science, biomedical engineering, and communication sciences and disorders. These practices help address functional and physiological lingual performance that are useful within a diverse scope of daily living features, such as swallowing, upper airway patency, articulation, pressure, strength, and endurance. Although the disclosed embodiments are illustrated and described herein as embodied in one or more specific examples, it is nevertheless not intended to be limited to the details shown, since various modifications and structural changes may be made without departing from the scope of inventions and within the scope and range of equivalents of the claims. In addition, various features from one embodiment may be incorporated into another of the embodiments. Accordingly, it is appropriate that the appended claims be construed broadly and, in a manner, consistent with the scope of the disclosure as set forth in the following claims. 
     The foregoing description has been presented for the purposes of illustration and description. It is not intended to be exhaustive or to limit the disclosure to the precise form disclosed. Many modifications and variations are possible in view of this disclosure. Indeed, while certain features of this disclosure have been shown, described and/or claimed, it is not intended to be limited to the details above, since it will be understood that various omissions, modifications, substitutions and changes in the apparatuses, forms, method, steps and system illustrated and in its operation can be made by those skilled in the art without departing in any way from the spirit of the present disclosure. 
     Furthermore, the foregoing description, for purposes of explanation, used specific nomenclature to provide a thorough understanding of the disclosure. However, it will be apparent to one skilled in the art that the specific details are not required in order to practice the disclosure. Thus, the foregoing descriptions of specific embodiments of the present disclosure are presented for purposes of illustration and description. They are not intended to be exhaustive or to limit the disclosure to the precise forms disclosed, many modifications and variations are possible in view of the above teachings. The embodiments were chosen and described in order to best explain the principles of the disclosure and its practical applications, to thereby enable others skilled in the art to best utilize the disclosed system and method, and various embodiments with various modifications as are suited to the particular use contemplated.