Protector for preventing oral injuries during intubation

Abstract

The present invention relates to an oral protector device comprising a dental tray having an arcuate end with two extending branches and a trough therein, a dental insert sized to fit within the trough of the dental tray, and a lip-protector flange extending from the arcuate end of the dental tray, such that the flange is capable of covering at least a portion of a subject's upper lip when the dental insert is positioned on the subject's upper oral maxillary arch.

Description

[0001] TITLE OF THE INVENTION Protector for Preventing Oral Injuries During Intubation

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No.

[0003] 63 / 604,985 filed on December 1, 2023, incorporated herein by reference in its entirety

[0004] BACKGROUND OF THE INVENTION

[0005] Laryngoscopy is a routine procedure that utilizes a laryngoscope for gaining visual access to the back of the throat. It is also generally used in order to facilitate tracheal intubation during general anesthesia, cardiopulmonary resuscitation, and for general surgery on the larynx or upper airway. A common complication of this procedure, unfortunately, is that it results in trauma to the lips, palate, gums and teeth of a patient during insertion of the laryngoscope. Presently, there exist devices for protecting the teeth or the palate, but there are no devices available to simultaneously protect the teeth, lips, gums and palate of the patient. The present invention meets this need.

[0006] SUMMARY OF THE INVENTION

[0007] The present invention relates to an oral protector device comprising a dental tray having an arcuate end with two extending branches and a trough therein, a dental insert sized to fit within the trough of the dental tray, and a lip-protector flange extending from the arcuate end of the dental tray, such that the flange is capable of covering at least a portion of a subject’s upper lip when the dental insert is positioned on the subject’s upper oral maxillary arch.

[0008] In some embodiments, the dental tray of the present invention is constructed from a material selected from the group consisting of acrylic, polycarbonate resins, polypropylene, carboxypolymethylene, polyethylene oxide, poly acrylic acid, and polyacrylamide PVP.

[0009] In some embodiments, the dental tray of the present invention covers the incisors, canines, premolars and first molars of the upper oral maxillary arch of teeth of the subject. In some embodiments, the dental insert of the present invention is constructed from a shapeable thermoplastic.

[0010] In some embodiments, the dental insert of the present invention is constructed from an isothermal deformable material, wherein the isothermal deformable material is selected from the group consisting of wax, gel, and resin.

[0011] In some embodiments, dental insert of the present invention is capable of covering the incisors, canines, premolars and first molars of the upper oral maxillary arch of teeth of the subject.

[0012] In some embodiments, the lip-protector flange of the present invention and the dental tray are a single unit.

[0013] In some embodiments, the lip-protector flange of the present invention is a separate component engageable with the dental tray.

[0014] In some embodiments, the dental insert and the dental tray of the present invention are a single unit.

[0015] In some embodiments, the dental insert of the present invention is a separate unit from the dental tray.

[0016] In some embodiments, the dental insert of the present invention is capable of removably engaging with the dental tray.

[0017] In some embodiments, the dental insert of the present invention substantially conforms to at least a portion of the upper maxillary arch of a subject.

[0018] In some embodiments, the dental tray of the present invention comprises a back wall, capable of covering at least a portion of the palate of the subject when the dental insert is positioned on the subject’s upper oral maxillary arch.

[0019] BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The following detailed description of preferred embodiments of the invention will be better understood when read in conjunction with the appended drawings. For the purpose of illustrating the invention, there are shown in the drawings embodiments which are presently preferred. It should be understood, however, that the invention is not limited to the precise arrangements and instrumentalities of the embodiments shown in the drawings. Figure 1 depicts a perspective view of an exemplary protector device of the present invention.

[0021] Figure 2 depicts a cross-sectional view of an exemplary protector device showing an exemplary dental insert attached to the top surface of an exemplary dental tray, and an exemplary lip flange extending to the front of the exemplary protector device.

[0022] Figure 3 depicts a top view of an exemplary protector device.

[0023] DETAILED DESCRIPTION

[0024] The present invention relates to a protector device for preventing trauma to the upper maxillary arch including teeth, gums, lips and the palate during medical procedures such as laryngoscopy and intubation.

[0025] It is to be understood that the figures and descriptions of the present invention have been simplified to illustrate elements that are relevant for a clear understanding of the present invention, while eliminating, for the purpose of clarity, many other elements found in typical laryngoscopy guards. Those of ordinary skill in the art may recognize that other elements and / or steps are desirable and / or required in implementing the present invention. However, because such elements and steps are well known in the art, and because they do not facilitate a better understanding of the present invention, a discussion of such elements and steps is not provided herein. The disclosure herein is directed to all such variations and modifications to such elements and methods known to those skilled in the art.

[0026] Definitions

[0027] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, the preferred methods and materials are described.

[0028] As used herein, each of the following terms has the meaning associated with it in this section. The articles “a” and “an” are used herein to refer to one or to more than one (i.e., to at least one) of the grammatical object of the article. By way of example, “an element” means one element or more than one element.

[0029] “About” as used herein when referring to a measurable value such as an amount, a temporal duration, and the like, is meant to encompass variations of ±20%, ±10%, ±5%, ±1%, or ±0.1% from the specified value, as such variations are appropriate to perform the disclosed methods.

[0030] Ranges: throughout this disclosure, various aspects of the invention can be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 2.7, 3, 4, 5, 5.3, and 6. This applies regardless of the breadth of the range.

[0031] Description

[0032] The present invention provides a protector device for protecting the oral cavity including the teeth, gums, lips and palate and minimizing trauma to these tissues during medical procedures such as laryngoscopy, intubation, administration of anesthesia, and similar procedures wherein these tissues are at risk for injury. In some embodiments, protector 10 may be placed in contact with the upper oral maxillary arch of a subject, thereby protecting structures of the oral cavity (i.e. teeth, palate, gums, lips) such that a medical procedure such as laryngoscopy may be performed, and risk of injury to the structures of the oral cavity is reduced.

[0033] Referring now to Figures 1-3, protector 10 of the present invention generally includes a dental tray 100, a lip protector flange 150, and optionally a dental insert 200. Dental tray 100 may have a generally U-shaped conformation curved in a manner such that it is positionable around the upper maxillary arch of teeth or gums in a subject. Tray 100 includes an arcuate end region 102 aligning with a subject’s incisors, and two extending branches 108 and 109 from end region 102 covering the subject’s canines and optionally the premolars and molars. Accordingly, tray 100 is sized to fit around a full arch or partial arch of a subject’s upper teeth. Dental tray 100 comprises a generally flat base 105, back wall 110, front wall 120, forming an open-topped trough sized to fit dental insert 200 therein. In some embodiments, tray 100 comprises a deep trough having a generally U-shaped cross-section. In some embodiments, tray 100 comprises a shallow trough having a generally flat cross-section. In some embodiments, the outer surface of base 105 may have a generally smooth surface. In some embodiments, the outer surface of base 105 may have a generally textured surface. In some embodiments, the outer surface of base 105 may have a generally contoured surface. In some embodiments, the generally contoured surface mimics the contoured surface of teeth or a dental impression thereof. In some embodiments, the inner surface of base 105 may have a generally smooth surface. In some embodiments, the inner surface of base 105 may have a generally textured surface. In some embodiments, the inner surface of base 105 may have a generally gripping surface that engages with the teeth and / or gums of the upper maxillary arch. In some embodiments, the inner surface of base 105 may have a variable surface. In some embodiments, the inner surface of base 105 may have an interlocking mechanism and / or interlocking means for engaging dental insert 200. Back wall 110 seamlessly curves vertically extending from base 105. In some embodiments, back wall 110 loosely conforms to the back surface of the upper maxillary arch of teeth and gums. In some embodiments, back wall 110 extends above the back surface of teeth and gums, and curves to conform to at least a portion of the palate. In some embodiments, back wall 110 may comprise a palate protector 115. Front wall 120 seamlessly curves vertically extending from base 105 and is positionable around the front curvature of the upper maxillary arch of teeth and gums. In some embodiments, front wall 120 extends a height such that it covers none or some of the front surface of the upper maxillary arch. In some embodiments, front wall 120 extends a height such that it substantially covers the front surface of the upper maxillary arch including the teeth and / or gums. Tn some embodiments, front wall 120 loosely conforms to the upper maxillary arch. In some embodiments, front wall 120 may or may not come in contact with the front surface of the upper maxillary arch. Dental tray 100 as described herein may be manufactured via standard molding and / or printing techniques using any suitable material for use in the oral cavity such as acrylic or polycarbonate resins, polypropylene, carboxypolymethylene, polyethylene oxide, poly acrylic acid, polyacrylamide PVP or other suitable sturdy polymeric materials suitable for trays and other dental applications as would be understood by those skilled in the art. In some embodiments, dental tray 100 is constructed of rigid material. In some embodiments, dental tray 100 is constructed of flexible material. In some embodiments, dental tray 100 may have a thickness of about 0.1 mm to 0.5 mm, 0.5 mm to 1 mm, 1 mm to 5 mm, 5 mm to 10 mm, and / or 10 mm to 20 mm. It should be appreciated that there is no limitation to the size of the dental trays provided by the present invention. Dental trays of the present invention may be sized to generally fit a subject by age, size, weight, gender, or may be designed to custom fit a particular subject in need thereof.

[0034] Lip protector flange 150 extends from front wall 120 at arcuate end 102 of tray 100 such that it covers or shields at least a portion of the upper lip of a subject when dental tray 100 and insert 200 are positioned on the subject’s upper maxillary arch of teeth and / or gums. Lip protector flange 150 may cover or shield the entire upper lip or a portion of the upper lip. For example, in some embodiments, flange 150 is aligned with the center of dental tray 100 and covers the upper lip a distance corresponding to at least the width of the incisor teeth or general location thereof of the subject. In some embodiments, flange 150 spans a width covering the upper lip corresponding to at least the width of the cuspid teeth, or general location thereof. In some embodiments, flange 150 spans a width covering the upper lip corresponding to at least the width of one or more of the premolar teeth, or general location thereof. In some embodiments, lip flange 150 extends a length or distance from front wall 120 such that flange 150 at least extends above the upper lip of the subject, but does not extend so far as to reach the nose of the subject. In some embodiments, lip flange 150 curves away from the maxillary region of the subject such that it extends at least the height of the nose but curves away from the face so as not to make contact with the nose of the subject. In some embodiments, lip protector flange 150 is a single unit with dental tray 100, such that the two structures are a continuous unit of material. In some embodiments, lip protector flange 150 is constructed from a separate unit of material from dental tray 100, and the two structures are fused to one another using suitable means known to those skilled in the art, such as thermal fusing, plastic welding, epoxy, other adhesive bonding, or any other suitable means understood by those skilled in the art. In some embodiments, lip protector flange 150 removably attaches to dental tray 100. In some embodiments, dental tray 100 and lip protector flange 150 comprise interlocking mechanisms such that lip protector flange 150 engages dental tray 100 by any attaching mechanism understood in the art (e.g., a snap fitting, a friction fitting, and the like). In some embodiments, device 10 comprises a set of multiple interchangeable and variable sized lip protector flanges such that the medical practitioner may select and attach a lip protector flange of the desired size (width, length, etc.) based on the patient’s lip size, oral cavity size, or based on the instrument to be inserted into the oral cavity during a medical procedure. It should be appreciated that there is no limitation to the size of the lip protector flanges provided herein. Lip protector flanges may be sized to generally fit a subject by age, size, gender, or may be designed to custom fit a particular subject in need thereof.

[0035] Referring again to Figures 1-3, protector device 10 may optionally include dental insert 200 which may have a generally U-shaped conformation with a generally arcuate end region 202 aligning with a subject’s incisors, and two extending branches 208 and 209. Extending branches 208 and 209 cover the subject’s canines and optionally the premolars and molars and extend from end region 202 while maintaining contact with the upper maxillary arch of teeth and / or gums in a subject. In some embodiments, dental insert 200 comprises front wall 210, base 220, and backwall 230 generally forming a curved trough optionally making contact with the upper maxillary arch when positioned in the subject’s mouth. In some embodiments, dental insert 200 comprises a deep trough having a generally U-shaped cross-sectional. In some embodiments, dental insert 200 comprises a shallow trough having a generally flat crosssection. In some embodiments, dental insert 200 comprises a generally solid soft material layer within the trough of tray 100. In some embodiments, dental insert 200 is in direct contact with the teeth and / or gums. In some embodiments, dental insert 200 may be shaped to conform to the teeth and / or gums of the upper maxillary arch using means known in the art. In some embodiments, dental insert 200 may be shaped by heating dental insert 200 using suitable means as known in the art, such as, for example, submerging in boiling water, thereby reaching the softening temperature of the material of dental insert 200 while remaining below the softening temperature of the dental tray. In some embodiments, protector device 10 may be placed on the upper maxillary arch of a subject while the temperature of the dental insert is above the softening temperature of the material of the dental insert, thereby conforming to the oral structures of the upper maxillary arch, such as teeth and / or gums of the subject. In some embodiments, the temperature of protector device 10 may be reduced to a temperature below the softening temperature of the dental insert thereby fixing or setting the shape of the dental insert to complement that of the upper oral maxillary arch of the subject. In some embodiments, dental insert 200 may be constructed of a material that is shapeable or deformable without requiring the addition of heat or a change in temperature, that is a material that is isothermal shapeable or deformable. In some embodiments, dental insert 200 may be manufactured by any standard molding and / or printing techniques as understood in the art using any generally malleable or compliant suitable material such as a thermoplastic material suitable for dental inserts or teeth-conforming trays and other dental applications as would be understood by those skilled in the art. For example, dental insert 200 may be constructed from any suitable material soft enough to take dental impressions, such as ethyl ene-vinyl acetate copolymers, silicone, and the like. In some embodiments, dental insert 200 may be constructed of a soft and / or shapeable and / or deformable material as known in the art such as a wax, resin, gel, or other suitable material known in the art such that when dental insert 200 is placed in contact with the upper maxillary arch, and appropriate pressure is applied, dental insert 200 conforms to the shape of the oral structures of the upper maxillary arch, such as the teeth and / or gums. Dental insert 200 as described herein may be fused to dental tray 100 by any suitable fusing means such as thermal fusing, plastic welding, epoxy, other adhesive bonding, or any other suitable means understood by those skilled in the art. In some embodiments, dental insert 200 and dental tray 100 comprise interlocking mechanisms such that dental insert 200 may be removably attached to dental tray 100. In some embodiments, dental insert 200 is injected, poured or spread into tray 100. In some embodiments, dental insert 200 may attach to tray 100 by means such as friction and / or surface tension. In some embodiments, protector device 10 may optionally not include dental insert 200, and instead tray 100 directly engages or is otherwise positionable about the upper maxillary arch of the subject.

[0036] The disclosures of each and every patent, patent application, and publication cited herein are hereby incorporated herein by reference in their entirety. While this invention has been disclosed with reference to specific embodiments, it is apparent that other embodiments and variations of this invention may be devised by others skilled in the art without departing from the true spirit and scope of the invention. The appended claims are intended to be construed to include all such embodiments and equivalent variations.

Claims

CLAIMSWhat is claimed is:

1. An oral protector device comprising: a dental tray having an arcuate end with two extending branches and a trough therein, a dental insert sized to fit within the trough of the dental tray; and a lip-protector flange extending from the arcuate end of the dental tray, such that the flange is capable of covering at least a portion of a subject’s upper lip when the dental insert is positioned on the subject’s upper oral maxillary arch.

2. The protector device of claim 1, wherein the dental tray is constructed from a material selected from the group consisting of acrylic, polycarbonate resins, polypropylene, carboxypolymethylene, polyethylene oxide, poly acrylic acid, and polyacrylamide PVP.

3. The protector device of claim 1, wherein the dental tray covers the incisors, canines, premolars, and first molars of the upper oral maxillary arch of teeth of the subject.

4. The protector device of claim 1, wherein the dental insert is constructed from a shapeable thermoplastic.

5. The protector device of claim 1, wherein the dental insert is constructed from an isothermal deformable material, wherein the isothermal deformable material is selected from the group consisting of wax, gel, and resin.

6. The protector device of claim 1, wherein the dental insert is capable of covering the incisors, canines, premolars, and first molars of the upper oral maxillary arch of teeth of the subject.

7. The device of claim 1, wherein the lip-protector flange and the dental tray are a single unit.

8. The device of claim 1, wherein the lip-protector flange is a separate component engageable with the dental tray.

9. The protector device of claim 1, wherein the dental insert and the dental tray are a single unit.

10. The protector device of claim 1, wherein the dental insert is a separate unit from the dental tray.

11. The protector device of claim 1, wherein the dental insert is capable of removably engaging with the dental tray.

12. The protector device of claim 1, wherein the dental insert substantially conforms to at least a portion of the upper maxillary arch of a subject.

13. The protector device of claim 1, wherein the dental tray comprises a back wall, capable of covering at least a portion of the palate of the subject when the dental insert is positioned on the subject’s upper oral maxillary arch.

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