Oral cavity retractor

Abstract

The present invention relates to a unitary oral retractor for use in dental procedures wherein the oral retractor comprises a vestibular ring; a lip ring; a wall connecting the vestibular ring and the lip ring; and a pair of indentations on opposing sides or substantially opposing sides on the vestibular ring and each of the indentations are depressed from an outer circumference or perimeter of the vestibular ring by about 4 mm or less. The present invention also relates to a method for making the unitary oral retractor.

Description

ORAL CAVITY RETRACTOR

[0001] The application claims priority to Russian Industrial Design Application No. 2024502694 / 49 filed May 14, 2024 which issued as Russian Industrial Design No. 143064 on August 1, 2024, which is incorporated herein by reference.

[0002] The present disclosure relates to a retracting device for retracting the lips of a patient during a dental examination and / or treatment and a method of making the device.

[0003] Oral cavity retracting, also known as cheek retractors, lip retractors, or tongue cups, are well known in the art for spreading or retracting portions of a patient’s lips and / or cheeks for examination and / or treatment by healthcare professionals. Exemplary oral cavity retractors are described in the art such as U.S. Patent Nos. 7,988,626 and 10,292,788, U.S. Patent Application Publication Nos. 2017 / 0196659, 2020 / 0188060, 2022 / 0249200, 2023 / 0210646, International Patent Application Publication No. 2025 / 008344 and China Patent Application Publication Nos. 103860214, 112022407 and 210121159. Some of the prior art devices use levers that are biased apart by an assistant, use flanges that cup and spread the lips, use devices that include metal or rigid plastic members. These prior art devices are difficult to manufacture, use and are often uncomfortable for the patient.

[0004] There is a need to provide an oral retractor that is easy to manufacture, simple to use and comfortable for the patient.

[0005] The present invention is an oral retractor that is easy to manufacture, simple to use and provides improved comfort to the patient during use.SUMMARY OF THE INVENTION

[0006] The present invention relates to an oral retractor for lips and cheeks that may be used during a dental procedure comprising a lip ring, a vestibular ring and a film or wall connecting the lip ring and vestibular ring. The oral retractor is formed as a single or unitary device, preferably by injection molding a flexible and resilient polymer over amore rigid, yet flexible polymeric vestibular ring and flexible polymeric lip ring to form the unitary oral retractor.

[0007] The oral retractor further comprises a pair of indentations, i.e. two, that are opposing sides or substantially opposing sides of the vestibular ring region. The indentations are position to accommodate the patient’s oral frenum or frenulum, preferably the lip frenum.

[0008] The oral retractor may also further comprise a pair of extension regions, i.e. two, that are opposing sides or substantially opposing sides of the vestibular ring region. In certain embodiments, the center of the indentations are about 90° from the center of the extension regions.BRIEF DESCRIPTION OF THE DRAWINGS

[0009] Figure 1 is a top side view of an embodiment of the oral retractor.

[0010] Figure 2 is a bottom view of the oral retractor of Figure 1.

[0011] Figure 3 is a top view the oral retractor of Figure 1.

[0012] Figure 4 is a side view the oral retractor taken along line SI-SI of Figure 1.

[0013] Figure 5 is a side view of the oral retractor taken along line SE-SE of Figure 1.

[0014] Figure 6 is an expanded view of the region A of Figure 3.DETAILED DESCRIPTION

[0015] The present inventions may be understood more readily by reference to the following detailed description taken in connection with any accompanying figures and examples, which form a part of this disclosure. It is to be understood that these inventions are not limited to the specific products, methods, conditions or parameters described and / or shown herein, and that the terminology used herein is for the purpose of describing particular embodiments by way of example only and is not intended to be limiting of the claimed inventions.

[0016] As employed above and throughout the disclosure, the following terms and abbreviations, unless otherwise indicated, shall be understood to have the following meanings.

[0017] In the present disclosure the singular forms “a”, “an”, and “the” include the plural reference, and reference to a particular numerical value includes at least that particularvalue, unless the context clearly indicates otherwise. Furthermore, when indicating that a certain element “may be” X, Y, or Z, it is not intended by such usage to exclude in all instances other choices for the element.

[0018] When values are expressed as approximations, by use of the antecedent “about”, it will be understood that the particular value forms another embodiment. As used herein, “about X” (where X is a numerical value) preferably refers to ±10% of the recited value, inclusive. For example, the phrase “about 8” preferably refers to a value of 7.2 to 8.8, inclusive; as another example, the phrase “about 8%” preferably refers to a value of 7.2% to 8.8%, inclusive. Where present, all ranges are inclusive and combinable. For example, when a range of “1 to 5” is recited, the recited range should be construed as optionally including ranges “1 to 4”, “1 to 3”, “1-2”, “1-2 & 4-5”, “1-3 & 5”, and the like. In addition, when a list of alternatives is positively provided, such a listing can also include embodiments where any of the alternatives may be excluded. For example, when a range of “1 to 5” is described, such a description can support situations whereby any of 1, 2, 3, 4, or 5 are excluded: thus, a recitation of “1 to 5” may support “1 and 3- 5, but not 2”, or simply “wherein 2 is not included”. The phrase “at least about x” is intended to embrace both “about x” and “at least x”. It is also understood that where a parameter range is provided, all integers within that range, and tenths thereof, are also provided by the invention. For example, “2 - 5 mm” includes 2 mm, 2.1 mms, 2.2 mm, 2.3 mm etc... up to 5 mms.

[0019] As shown in Figure 1, the oral retractor of the present invention is a unitary structure 10 comprising a vestibular ring 20, a lip ring 30 and a film or wall 40 connecting the vestibular ring 20 and the lip ring 30. The vestibular ring 20 further comprises a pair of indentations 50 and 52. The vestibular ring 20 and the lip ring 30 are made of rigid yet flexible plastic polypropylene or polyethylene. The film or wall 40 is made of flexible film such as a thermo polyurethane a linear low density polyethylene as described in International Patent Application Publication No. 2025 / 008344 which is incorporated herein by reference.10020] In certain embodiments, the oral retractor is made as a single or unitary structure. In one aspect of this embodiment, the unitary oral retractor is made by injection molding comprising the steps of (i) forming the vestibular ring 20 and lip ring 30 in a mold and(ii) injecting the material for forming the wall 40 into the mold to cause the material for forming the wall to completely or partially surround or overcoat the vestibular ring 20 and lip ring 30 forming a vestibular ring region (the vestibular ring 20 coated by the wall material) and a lip ring region (the lip ring 30 coated by the wall material) and the wall 40 connecting the vestibular ring 20 and lip ring 30.

[0021] The shape of the vestibular ring 20 and the shape of the lip ring 30 may be circular or deviate from a circular shape to form an oval shape. In all cases, the shape of the vestibular ring 20 and lip ring 30 is a closed ring shape and preferably a single unitary ring. The circumference (in the case of a circular shape) or perimeter (in the case of an oval shape) of the lip ring 30 is always larger than the circumference or perimeter of the vestibular ring 20. This difference in ring circumference / perimeter causes the oral retractor to have a trapezoid shape when viewed from the side as shown in Figures 4 and 5. The lip ring 30 circumference / perimeter to vestibular ring 20 circumference / perimeter ratio ranges from about 1 :0.35 to about 1 :0.75 or preferably about 1:0.40 to 1:0.70.

[0022] In certain embodiments the pair of indentations 50 and 52 on the vestibular ring 20 are formed on opposing sides or substantially opposing sides, of the vestibular ring 20. As used herein substantially opposing means 180° ± 15°, preferably 180° ± 10° and more preferably 180°± 5° or any values within the range. For example, 180° ± 10° encompasses 170° to 190° and any values within the range such as 175°, 176°, 178°, 185°, 186° and 187°. The term opposing sides means 180° and includes minor manufacturing variations, typically ± 2° or ± 1°. In certain aspects, the wall forming material surrounds the indentations 50 and 52 and thereby form a continuous surface (free of openings or gaps) from the wall 40, vestibular ring 20 and the indentations 50 and 52.

[0023] The indentations are sized to correspond and accommodate the patient’s oral frenum, preferably the lip or labial frenum. As shown in Figure 6 the indentations 50 and 52 are curved or depressed D from the outer circumference / perimeter of the vestibular ring 20 or vestibular ring region by about 4 mm or less, preferably about 3.5 mm or less and more preferably about 3 mm or less. In certain aspects the indentation D ranges from about 0.75 mm to about 2.5 mm, preferably about 1 mm to about 2 mm. In certainaspects the length of the trough T of the indentations 50 and 52 can be about 3.0 mm,3.1 mm, 3.2 mm, 3.3 mm, 3.4 mm, 3.5 mm, 3.6 mm, 3.7 mm, 3.8 mm, 3.9 mm, 4.0 mm,4. 1 mm, 4.2 mm, 4.3 mm, 4.4 mm, 4.5 mm, 4.6 mm, 4.7 mm, 4.8 mm, 4.9 mm, 5.0 mm,5.1 mm, 5.2 mm, 5.3 mm, 5.4 mm, 5.5 mm, 5.6 mm, 5.7 mm, 5.8 mm, 5.9 mm, 6.0 mm,6.1 mm, 6.2 mm, 6.3 mm, 6.4 mm, 6.5 mm, 6.6 mm, 6.7 mm, 6.8 mm, 6.9 mm, 7.0 mm,7.1 mm, 7.2 mm, 7.3 mm, 7.4 mm, 7.5 mm or any range within the aforementioned values such as about 3. 1 mm to about 7.0 mm, about 3.3 mm to about 6.8 mm or about 3.5 mm to about 6.6 mm.

[0024] The vestibular ring may also comprise a pair of extension regions 60 and 62 that are on opposing sides or substantially opposing sides, of the vestibular ring region. The center point of the extension regions 60 and 62 are about 90° + 10° from the center point of the indentations 50 and 52. The extension regions are formed during the injection molding process by (i) forming a thicker region on the vestibular ring 20, (ii) making the wall material surrounding the vestibular ring thicker than the amount of wall material surrounding other areas of the vestibular ring such as the indentations or a combination of (i) and (ii). As shown in Figure 4 and 5, in certain embodiments the length from the base of the lip region to the top of the extension region LE is about 1.5 mm to about 4.4 mm greater than the length from the base of the lip region to the top of the indentation region Li, preferably about 1.75 mm to about 4.0 mm and more preferably about 2.0 mm to about 3.5 mm.

[0025] In some embodiments the length of the wall 40 is longer at the extension region 60 and 62 and shorter at the indentations 50 and 52. This difference in length will result in a concave base and convex top when viewed from the extension region side and a convex top and convex base when viewed from the indentation side.

[0026] The wall 40 is formed of a flexible polymeric material such as a polyurethane or a linear low density polyethylene. The thickness of the wall 40 between the vestibular ring 20 and lip ring 30 should be unform or substantially uniform. Substantially uniform with respect to the wall thickness means a thickness of + 10%, ± 5% or ± 2.5% when measured at any point of the wall below the vestibular ring 20 or vestibular ring region and above the lip ring 30 or lip ring region. The thickness of the wall 40 should may be about 150 microns, 175 microns, 200 microns, 225 microns, 250 microns, 275microns, 300 microns, 325 microns, 350 microns, 375 microns, 400 microns, 425 microns, 450 microns, 475 microns, 500 microns, 525 microns, 550 microns, 575 microns, 600 microns, 625 microns, 650 microns, 675 microns, 700 microns or any range within the aforementioned values such as about 200 microns to about 550 microns, about 250 microns to about 500 microns, 300 microns to about 450 microns, or about 350 microns to about 400 microns. The thickness of the wall 40 should be sufficient to maintain the target length and shape between the vestibular ring 20 and lip ring 30 when no force is applied to the oral retractor but can be easily deformed (stretched or compressed) when a force is applied to the oral retractor. In certain aspects, the wall 40 is free of any supports, corset, thickened regions or other structures that aid in maintaining the shape of the oral retractor when no external force is applied to the oral retractor. In certain aspects the shape of the wall 40 is determined and maintained by the shape of the vestibular ring 20 and the shape of the lip ring 30 and / or the lengths of the wall between the vestibular ring 20 and the lip ring 30.

[0027] The oral retractor may optionally further comprise one or more projections 70 and 72 that extend traversely from the lip ring 30 or the lip ring region (i.e., the lip ring 30 surrounded by wall forming material). The projections 70 and 72 can function to correctly place the oral retractor in the patient’s mouth. For example, the one or more projections may be extend from one side of the lip ring 30 which will correspond to the bottom of the oral retractor when placed in the patient’s oral cavity and will be between the patient’s lower lip and chin when in use. The projections 70 and 72 may also contain useful indicia such as size (small, medium, large etc). The projects may be formed from the same material used to form the lip ring 30 or the wall 40.10028] In certain embodiments the oral retractor will have an oval shape may have the following dimensions:

[0029] All references, patents or applications, U.S. or foreign, cited in the application are hereby incorporated by reference as if written herein in their entireties. Where any inconsistencies arise, material literally disclosed herein controls.

[0030] The invention described herein may be practiced in the absence of any element or elements, limitation or limitations which is not specifically disclosed herein. Thus, for example, in each instance herein, any of the terms “comprising,” “consisting essentially of,” and “consisting of’ may be replaced with either of the other two terms. The terms and expressions which have been employed are used as terms of description and not of limitation, and there is no intention in the use of such terms and expressions of excluding any equivalents of the features shown and described or portions thereof, but it is recognized that various modifications are possible within the scope of the invention claimed. Thus, it should be understood that although the present invention has been specifically disclosed by preferred embodiments and optional features, modification and variation of the concepts herein disclosed may be resorted to by those skilled in the art, and that such modifications and variations are considered to be within the scope of this invention as defined by the claims.

Claims

CLAIMS1. An oral retractor comprising (i) a vestibular ring; (ii) a lip ring; (iii) a wall connecting the vestibular ring and the lip ring; (iv) a pair of indentations on opposing sides or substantially opposing sides on the vestibular ring wherein the oral retractor is a unitary structure and each of the indentations are depressed from an outer circumference or perimeter of the vestibular ring by about 4 mm or less.

2. The oral retractor of claim 1 wherein each of the indentations are depressed from the outer circumference or perimeter of the vestibular ring by about 3.5 mm or less.

3. The oral retractor of claim 1 wherein each of the indentations are depressed from the outer circumference or perimeter of the vestibular ring by about 3.0 mm or less.

4. The oral retractor of claim 1 wherein each of the indentations are depressed from the outer circumference or perimeter of the vestibular ring by about 0.75 mm to about 2.5 mm.

5. The oral retractor of claim 1 wherein each of the indentations are depressed from the outer circumference or perimeter of the vestibular ring by about 1.0 mm to about 2.0 mm.

6. The oral retractor of claim 1 further comprising a pair of extension regions that are on opposing sides or substantially opposing sides of the vestibular ring region and about 90° ± 10° from the center point of the indentations.

7. The oral retractor of claim 1 wherein the wall between the vestibular ring and lip ring is unform or substantially uniform and free of any additional support structures.

8. A method for making the oral retractor of claim 1 comprising the steps of (i) forming the vestibular ring and the lip ring in a mold and (ii) injecting a material for forming the wall into the mold to cause the material for forming the wall to completely or partially surround or overcoat the vestibular ring and lip ring forming a vestibular ring region, a lip ring region and the wall connecting the vestibular ring and lip ring.

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