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Title:
HIGH PERFORMANCE MOUTHGUARD
Document Type and Number:
WIPO Patent Application WO/2011/153131
Kind Code:
A1
Abstract:
Described herein is a high performance mouthguard. Generally, the mouthguard includes a base that includes at least one facial wall, at least one lingual structure extending from the base such that the base, the facial wall, and the lingual structure define a trough having an inner surface, a heat-softenable material disposed in the inner surface, defining a channel, and at least one protrusion that includes a heat-softenable material projecting into the channel from the heat-softenable material disposed on the inner surface of at least one of the at least one facial wall and the at least one lingual structure.

Inventors:
COOK WILLIAM (US)
HERMAN MARK H (US)
Application Number:
PCT/US2011/038532
Publication Date:
December 08, 2011
Filing Date:
May 31, 2011
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
BITE TECH INC (US)
COOK WILLIAM (US)
HERMAN MARK H (US)
International Classes:
A63B71/08
Domestic Patent References:
WO2006108209A12006-10-19
Foreign References:
DE19844628A12000-04-06
EP0875265A11998-11-04
US7210483B12007-05-01
US61350327A
US6505626B22003-01-14
US6505627B22003-01-14
US6505628B22003-01-14
US6508251B22003-01-21
US6510853B12003-01-28
US6588430B22003-07-08
US6675806B22004-01-13
US6675807B22004-01-13
US6691710B22004-02-17
US7299804B22007-11-27
Attorney, Agent or Firm:
GRAM, Christopher, D. (P.A.P.O. Box 58133, Minneapolis MN, US)
Download PDF:
Claims:
What is claimed is:

1. A mouthguard comprising:

a base comprising at least one facial wall;

at least one lingual structure extending from the base such that the base, the facial wall, and the lingual structure define a trough having an inner surface;

a heat-softenable material disposed in the inner surface, defining a channel; and at least one protrusion comprising a heat-softenable material projecting into the channel from the heat-softenable material disposed on the inner surface of at least one of: the at least one facial wall and the at least one lingual structure.

2. The mouthguard of claim 1 wherein the heat-softenable material of the protrusion is positioned so that, when the heat-softenable material is softened and the mouthguard is fitted over a user's dentition, the heat-softenable material of the protrusion infiltrates space between the user's teeth.

3. The mouthguard of claim 1 wherein at least one of the base, the at least one lingual wall, and at least one facial wall comprises a heat-softenable material.

4. The mouthguard of claim 1 wherein a plurality of protrusions project from the heat-softenable material disposed on the inner surface of the facial wall.

5. The mouthguard of claim 1 wherein at least one protrusion comprises a rounded surface facing toward the channel.

6. The mouthguard of claim 1 wherein the heat-softenable material of at least one protrusion is greatest near the base and tapers as the protrusion extends along the wall.

7. The mouthguard of claim 1 wherein the base comprises one or more recesses positioned to accept one or more cusps of one or more of a user's teeth.

8. The mouthguard of claim 1 wherein the facial wall comprises:

a labial portion comprising a thickness; and

a lateral portion comprising a thickness;

wherein the thickness of the labial portion of the facial wall is greater than the thickness of the lateral portion of the facial wall.

9. The mouthguard of claim 1 wherein the facial wall comprises:

a labial portion comprising a thickness; and

a posterior portion comprising a thickness;

wherein the thickness of the labial portion of the facial wall is greater than the thickness of the posterior portion of the facial wall.

Description:
HIGH PERFORMANCE MOUTHGUARD

CROSS-REFERENCE TO RELATED APPLICATION This application claims priority to U.S. Provisional Patent Application Serial No. 61/350,327, filed June 1, 2010, which is hereby incorporated by reference in its entirety. BACKGROUND

A number of mouthguards currently exist in the art for protecting the teeth and for reducing the chance of shock, concussions, and other injuries as a result of high impact collisions and blows during athletic competition. Mouthguards generally are

characterized as being non-personalized, universal and stock model type, or are formed to have direct upper jaw tooth-formed contact. These are customizable mouthguards.

Additionally, the mouthguards may be tethered or untethered. Mouthguards may be tethered to a fastening point, such as a helmet or face guard, to prevent the chance of the mouthguard from being lost as well as to prevent swallowing of the mouthguard or choking on the mouthguard by the user.

The lack of a mouthguard or the use of an improperly fitted mouthguard have been found to be responsible for illnesses and/or injuries resulting from impacts, collisions, or blows that occur to the jaw structure of an athlete. Such injured athletes are susceptible to headaches, presence of earaches, ringing in the ears, clogged ears, vertigo, concussions and dizziness. The cause of these types of health problems and injuries are generally not visible by inspection of the mouth or the jaw but more particularly relate to the temporomandibular joint (TMJ) and surrounded tissues where the lower jaw is connected to the skull in the proximity where the auriculo-temporalis nerves and supra- temporo arteries pass from the neck into the skull to the brain.

In addition to protection of the teeth and the TMJ, athletes clench their teeth during exertion, which can result in hundreds of pounds of compressed force exerted from the lower jaw onto the upper jaw. Such clenching can result in headaches, muscle spasms, damage to teeth, injury to the TMJ, and pain in the jaw. Furthermore, clenching of the teeth makes breathing more difficult during physical exercise.

Most importantly, many problems exist with prior mouthguards. Mouthguards with a rigid labial or buccal walls may not readily accept wide teeth, were bulky, and/or have sharp edges. When the custom appliances were placed in hot water to soften for fitting, the mouthguards tended to collapse and permit portions to touch and stick together upon removal from the hot water, thus creating problems fitting such

mouthguards. Delamination and chewing destruction caused short life of the

mouthguards. SUMMARY OF THE INVENTION

The present invention provides a mouthguard. Generally, the mouthguard includes a base that includes at least one facial wall, at least one lingual structure extending from the base such that the base, the facial wall, and the lingual structure define a trough having an inner surface, a heat-softenable material disposed in the inner surface and thereby defining a channel, and at least one protrusion that includes a heat- softenable material projecting into the channel from the heat-softenable material disposed on the inner surface of at least one of the at least one facial wall and the at least one lingual structure.

In some embodiments, the heat-softenable material of the protrusion is positioned so that, when the heat-softenable material is softened and the mouthguard is fitted over a user's dentition, the heat-softenable material of the protrusion infiltrates space between the user's teeth.

In some embodiments, at least one of the base, the at least one lingual wall, and at least one facial wall comprises a heat-softenable material.

In some embodiments, a plurality of protrusions project from the heat-softenable material disposed on the inner surface of the facial wall.

In some embodiments, at least one protrusion comprises a rounded surface facing toward the channel.

In some embodiments, the heat-softenable material of at least one protrusion is greatest near the base and tapers as the protrusion extends along the wall. In some embodiments, the base comprises one or more recesses positioned to accept one or more cusps of one or more of a user's teeth.

In some embodiments, the thickness of the labial portion of the facial wall is greater than the thickness of the lateral or posterior portion of the facial wall.

The above summary of the present invention is not intended to describe each disclosed embodiment or every implementation of the present invention. The description that follows more particularly exemplifies illustrative embodiments. In several places throughout the application, guidance is provided through lists of examples, which examples can be used in various combinations. In each instance, the recited list serves only as a representative group and should not be interpreted as an exclusive list.

BRIEF DESCRIPTION OF THE FIGURES FIG. 1 illustrates a top perspective view of an exemplary embodiment of a mouthguard.

FIG. 2 illustrates a top view of an exemplary embodiment of a mouthguard.

FIG. 3 illustrates a rear view of an exemplary embodiment of a mouthguard. All Figures are illustrated for ease of explanation of the basic teachings of the present invention only; the extensions of the Figures with respect to number, position, relationship and dimensions of the parts to form the embodiment will be explained or will be within the skill of the art after the following description has been read and understood. Further, the exact dimensions and dimensional proportions to conform to specific force, weight, strength, and similar requirements will likewise be within the skill of the art after the following description has been read and understood.

Where a numeral is used in various Figures of the drawings, the numeral designates the same or similar parts in the various Figures in which it is used.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

The present invention provides a mouthguard that may be fitted particularly to the upper teeth of an individual. It has been discovered that prior custom fittable

mouthguards do not optimally fit a user's teeth. As a result, certain characteristics of the mouthguard such as, for example, fit, performance, durability, and/or comfort may be compromised. Thus, the mouthguard described herein can provide a better, more complete, and more customized fit than prior mouthguards and, therefore, provide better comfort, fit, durability, and/or performance.

Generally, the mouthguard described herein includes heat-softenable material in addition to the heat softenable material provided by existing custom fittable mouthguards. The additional heat-softenable material can infiltrate spaces between teeth that are not infiltrated by existing mouthguards, which lack the additional heat-softenable material.

As used herein, the following terms shall have the indicated meanings:

"Heat-softenable" refers to materials that soften and become moldable when heated to a temperature within a glass transition temperature range of from about 120°F to about 200°F.

"Non-softenable" refers to materials that do not soften and become moldable when heated to a temperature of 200°F or less.

The term "and/or" means one or all of the listed elements or a combination of any two or more of the listed elements.

The terms "comprises" and variations thereof do not have a limiting meaning where these terms appear in the description and claims.

Unless otherwise specified, "a," "an," "the," and "at least one" are used interchangeably and mean one or more than one.

Also herein, the recitations of numerical ranges by endpoints include all numbers subsumed within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, 5, etc.).

Furthermore, when the terms "top," "bottom," "right," "left," "forward,"

"rearward," "front," "rear," "first," "second," "inside," "outside," "upper," "lower," "inferior," "superior," "anterior," "posterior," "proximal," "distal," "facial," "buccal," "labial," "oral," "lingual," "palatal," "mesial," and similar positional and/or relative terms are used, the terms should be understood to refer to structures shown in the drawings as they will typically be utilized by one skilled in the art or otherwise as would be recognized by one skilled in the art.

The present invention generally provides a mouthguard that may be custom fit to the dentition of a user. The mouthguard generally includes a heat-softenable material shaped to fit over the teeth of the maxillary arch. In use, the heat-softenable material may be heated sufficiently to soften the material so that the heat-softenable material is moldable around the teeth of the maxillary arch. The heat-softenable material may be placed over the teeth of the maxillary arch and then molded to the dentition of the user and then allowed to cool to produce a mouthguard custom fit to the user. The molding of the softened heat-softenable material may be performed by the user forcing the maxillary teeth into the softened heat-softenable material.

Custom fitting the mouthguard can involve immersing the mouthguard into water that has been heated to or above the glass transition temperature of the heat-softenable material. In some cases, the water may be boiling. In other cases, however, the water may be heating to a sub-boiling temperature and still be warm enough to soften the heat- softenable material.

After the heat-softenable material has been softened, the mouthguard can be inserted into the mouth and registered with the maxillary arch. The user then exerts a force pressing the maxillary teeth into the softened heat-softenable material, thereby causing the heat-softenable material to conform to the contours of at least a portion of the user's maxillary teeth and, optionally, at least a portion of the user's gums. The user may exert the force by providing a biting force to the mouthguard. Alternatively, the user may exert the force by pressing the mouthguard upwardly into the maxillary teeth with the tongue or a finger.

Turning now to the Figures, a mouthguard 10 is generally depicted in FIG. 1. The mouthguard includes a base 12 that includes a facial wall 14. A lingual structure 16 extends from the base 12 opposite the facial wall 12. Together, the base 12, facial wall 14, and lingual structure 16 define a trough 18 having an inner surface 20.

Each of the base 12, facial wall 14, and lingual structure 16 may independently of one another be formed from either a heat-softenable material or a non-softenable material. Heat-softenable materials and non-softenable materials are described in detail below.

A heat-softenable material is disposed on the inner surface 20 of the trough 18. The heat-softenable material defines a channel 22 sized and shaped to accept at least a portion of a user' s maxillary teeth. In embodiments in which at least one of the base 12, facial wall 14, and lingual structure 16 are formed from a non-softenable material, the heat-softenable material and the component formed from the non-softenable material may be attached, affixed, adhered, or otherwise assembled to one another in any suitable manner. FIG. 3 illustrates an exemplary embodiment in which the base 12, facial wall 14, and lingual structure 16 are formed from a non-softenable material so that the trough 18 and the heat-softenable material that defines the channel 22 are readily distinguishable.

In alternative embodiments, however, one or more of the base 12, facial wall 14, and lingual structure 16 may be formed from a heat-softenable material. In such embodiments, the heat-softenable material forming the inner surface 20 of the trough 18 may also be considered to be the heat-softenable material "disposed" on the inner surface 20 of the trough 18 even though no additional layer of heat-softenable material is present. Thus, in some embodiments, a portion of trough 18 may be structurally indistinguishable from a portion of the heat-softenable material that defines the channel 22.

One or more protrusions 24 of heat-softenable material project into the channel 22 from the heat-softenable material disposed on the inner surface 22 of the trough 18. The heat-softenable material of each protrusion 24 may independently of one another, and independently of the heat-softenable material disposed on the inner surface 20 of the trough 18, be formed from the same heat-softenable material or different heat-softenable materials. Each protrusion 24 may, independently of one another, project from the heat- softenable material disposed on the inner surface 20 of the facial wall 14 or the inner surface 20 of the . lingual structure 16, or project into the channel 22 from the inner surface 20 of both the facial wall 14 and the lingual structure 16. In embodiments in which protrusions 24 project into the channel 22 from the inner surface 20 of both the facial wall 14 and the lingual structure 16, the contours of the maxillary dentition may be more completed enveloped, thereby providing a more thorough fitting of the mouthguard 10.

When the mouthguard is being fitted, the heat-softenable material of the protrusions 24 can infiltrate the spaces between a user's teeth to a greater degree than is possible for mouthguards that lack this additional heat-softenable material. The presence of additional heat-softenable material provides more material to infiltrate spaces and provide more complete filling of the contours of the user's maxillary teeth and gums. Moreover, the protrusions 24 may be positioned to optimize infiltration of the protrusion heat-softenable material into spaces between teeth. Finally, the protrusions 24 may be formed from different heat-softenable material than the heat-softenable material disposed on the inner surface 20 of the trough 18. In some embodiments, the protrusion 24 heat- softenable material may, when heated and softened, be less viscous and, therefore, infiltrate spaces between teeth more readily than is possible for the heat-softenable material disposed on the inner surface 20 of the trough 18. As noted above in the Background, when mouthguards are formed from less viscous heat-softenable materials, which may promote more complete fitment, the walls of the mouthguard may collapse, thereby making proper fitting of the mouthguard more difficult. Providing sources of less viscous heat-softenable material in structures— i.e., as protrusions 24— that are not required to maintain the general integrity of the mouthguard can introduce the relatively more flowable heat-softenable materials into the mouthguard 10 in a way that does not compromise the integrity of the form of the mouthguard 10 as a whole during the custom fitting process.

The protrusions 24 may be provided having any suitable geometry or,

alternatively, may be provided with no consistent shape. Moreover, when a plurality of protrusions 24 are provided, each of the plurality of protrusions 24 may be of identical, similar, or dissimilar shape. Certain shapes, however, may be preferred in certain embodiments.

For example, as shown in FIGS. 1-3, one or more protrusions 24 may include a rounded surface facing toward the channel 22. In such embodiments, the rounded surface can improve comfort while the mouthguard 10 is being fitted. In some embodiments, a protrusion 24 may be generally semi-conical, possessing more heat-softenable material near the base 12 and tapering as the protrusion 24 extends upward along the wall 14. In such embodiments, the rounded surface may provide comfort while the mouthguard 10 is being fitted. In addition, the relatively greater amount of heat-softenable material near the base can provide optimal fit in an area where the total volume of fillable recesses between teeth and in the cusps of the teeth may be greatest. As shown in FIG. 1 and FIG. 2, the base 12 can include one or more recesses 26 positioned to accept one or cusps of one or more teeth. Each recess 26 may be formed in heat-softenable material so that, upon fitting, the heat softenable material defining the recess 26 can fill spaces between teeth and/or the spaces in the cusps of the teeth. This, too, can improve fit and, therefore, comfort of the mouthguard 10 for the user.

Alternatively, each recess 26 may be formed in non-sof enable material. In such embodiments, the area including and surrounding the recesses 26 may be better constructed to withstand wear and/or destruction from biting and/or chewing forces and, therefore, offer greater durability.

The presence of one or more recesses 26 and/or heat-softenable material of the protrusions 24 can provide certain benefits. One benefit is a more complete and individualized fit for the mouthguard 10. A more complete and individualized fit can result in increased comfort for the user, which can increase the likelihood that a user will wear the mouthguard 10 as designed and, therefore, enjoy that maximum performance and/or protective benefit of using the mouthguard 10. Better fit also improves the likelihood that the mouthguard 10 will remain in the intended, proper position when in use. This, too, increases the likelihood that the user can enjoy the maximum performance and/or protective benefit of using the mouthguard 10. Another consequence of the mouthguard 10 remaining in its intended, proper position is that the mouthguard 10 may be less exposed to the user removing and chewing on the mouthguard 10, which can promote delamination of mouthguard components and/or premature destruction of the mouthguard 10.

Another benefit that may be provided by the protrusions 24 includes addition material providing performance benefits such as, for example, impact absorption. Impact force may originate from, for example, impacts, collisions, and/or blows associated with athletic competition and/or clenching stress. Regardless of the source of the impact force, additional impact absorption capacity provided by additional heat-softenable material can improve the performance and/or protection offered by the mouthguard 10 and, therefore, improve the performance of the user.

In some embodiments, the thickness of the facial wall 14 may vary. This feature can improve fitting and comfort for the user. FIG. 2 illustrates that the labial portion of the facial wall 30 is, generally, the front portion of the mouthguard 10, the portion that, in use, may fit over the incisors. Likewise, the lateral portion of the facial wall 32 is shown as the portion of the mouthguard 10 that, in use, may fit generally over the bicuspids (or premolars). The posterior portion of the facial wall 34 is shown as the portion of the mouthguard 10 that, in use, may fit over the molars, particularly the second molar.

The labial thickness 31 may have a minimum thickness of at least 3 mm such as for example, at least 4 mm, at least 5 mm, or at least 6 mm. The labial thickness 31 may have a maximum thickness of no more than 8 mm such as, for example, no more than 7 mm, no more than 6 mm, no more than 5 mm, or no more than 4 mm. In various embodiments, the labial thickness 31 may be within a range defined by any combination of minimum labial thickness and maximum labial thickness. In certain embodiments, the labial thickness 31 may be, for example, about 4 mm, about 5 mm, or about 6 mm. In one particular embodiment, the labial thickness 31 may be about 5 mm.

The lateral thickness 33 may have a minimum thickness of at least 1 mm such as for example, at least 1.5 mm, at least 2 mm, at least 2.5, at least 3, or at least 3.5 mm. The lateral thickness 33 may have a maximum thickness of no more than 4 mm such as, for example, no more than 3.5 mm, no more than 3 mm, no more than 2.5 mm, no more than 2, or no more than 1 mm. In various embodiments, the lateral thickness 33 may be within a range defined by any combination of minimum lateral thickness and maximum lateral thickness. In certain embodiments, the lateral thickness 33 may be, for example, about 2.5 mm, about 3 mm, or about 3.5 mm. In one particular embodiment, the lateral thickness 33 may be about 3 mm.

The posterior thickness 35 may have a minimum thickness of at least 0.25 mm such as for example, at least 0.5 mm, at least 1 mm, at least 1.5, or at least 2 mm. The posterior thickness 35 may have a maximum thickness of no more than 3 mm such as, for example, no more than 2.5 mm, no more than 2 mm, no more than 1.5 mm, or no more than 1 mm. In various embodiments, the posterior thickness 35 may be within a range defined by any combination of minimum posterior thickness and maximum posterior thickness. In certain embodiments, the posterior thickness 35 may be, for example, about 0.5 mm, about 1 mm, or about 1.5 mm. In one particular embodiment, the lateral thickness 33 may be about 1 mm. In some embodiments, the labial thickness 31 may be greater than the posterior thickness 35. In other embodiments, the labial thickness 31 may be greater than the lateral thickness 33. In still other embodiments, the labial thickness 31 may be greater than both he lateral thickness 33 and posterior thickness 35.

In some embodiments, differences in thickness of the various portions of the facial wall 14 may be expressed in absolute units, in terms of being some percentage, ratio, or fold greater than either or both of the lateral thickness 33 and posterior thickness 35, or in any other manner of comparing two values. Thus, in some embodiments, the labial thickness 31 may be greater than the lateral thickness 33 by, for example, 4 mm, 3.5 mm, 3 mm 2.5 mm, 2 mm, 1.5 mm, 1 mm, or 0.5 mm. Alternatively, in some embodiments, the labial thickness 31 may be greater than the posterior thickness 35 by, for example, 2 mm, 2.5 mm, 3 mm, 3.5 mm, 4 mm, 4.5 mm, 5 mm, or 5.5 mm. In other embodiments, the labial thickness 31 may be, for example, 2-fold, 2.5-fold, 3-fold greater than the lateral thickness 33. As used herein, a 2-fold increase reflects a 2:1 ratio such as one may find in an embodiment in which the lateral thickness 33 is 2 mm and the labial thickness 31 is 4 mm. In other embodiments, the labial thickness 31 may be expressed as being, for example, 125%, 150%, 180%, 200% (i.e., the aforementioned 2:1 ratio or being 2-fold greater), or 250% of the lateral thickness 33. Similarly, in some

embodiments, the labial thickness 31 may be, for example, 2-fold, 3-fold, 4-fold, 5-fold, 6-fold, 7-fold, 8-fold, 9-fold, or 10-fold greater than the posterior thickness 35.

In some embodiments, the mouthguard can include one or more components in addition to the components described in detail herein. Such additional components may be mouthguard components such as, for example, one or more components described in detail in one or more of U.S. Pat. No. 6,505,626; 6,505,627; 6,505,628; 6,508,251;

6,510,853; 6,588,430; 6,675,806; 6,675,807; 6,691,710; and 7,299,804.

Heat-Softenable Material

The heat-softenable material may be any suitable material that softens and becomes moldable when heated to a temperature between about 120°F and 200°F.

Suitable heat-softenable materials can therefore be softenable within a glass transition temperature range of as low as 120°F to as high as about 200°F such as, for example, within a glass transition temperature range of, for example, from about 140°F to approximately 185°F or 190°F.

Suitable materials include, for example, low melt temperature ethylene vinyl acetate (EVA) thermoplastics. In some embodiments, the heat-softenable material softens sufficiently for deformation to receive the impression of teeth after being immersed in water at a temperature range of approximately 140°F to approximately 180°F for approximately two minutes.

In some embodiments, the heat-softenable material can include a

polycaprolactone such as, for example, polycaprolactone CAP A 6500 (Perstorp UK, Ltd., Cheshire, UK) or TONE (P-767, Union Carbide Corporation, Piscataway, NJ). A polycaprolactone may be used alone or, for example, in a mixture with EVA. In other embodiments, the heat-softenable material can include a mixture of polycaprolactone and a polyolefin elastomer such as, for example, a copolymer of ethylene and octene-1 (e.g., ENGAGE, Dupont Canada, Inc., Mississauga, Ontario). In other embodiments, the heat- softenable material may be a thermoplastic olefin such as, for example ADFLEX

(LyondellBasell Industries N.V., Rotterdam, Netherlands). In other embodiments, the heat-softenable material may be a thermoplastic polyurethane having a low melt point (e.g., less than 160°F) such as, for example, certain ΤΕΧΓΝ thermoplastic polyurethanes (Bayer AG, Leverkusen, Germany). In still other embodiments, the heat-softenable material may be a thermoplastic polyolefin such as, for example, EXACT (ExxonMobil Chemical Co., Houston, TX).

Non-softenable Material

The non-softenable material may be any suitable material that does not appreciably softens and remains substantially unmoldable when heated to a temperature of about 200°F. Suitable non-softenable materials include thermoplastic materials such as, for example, higher melt temperature thermoplastics including, for example, certain EVA copolymer resins such as EL VAX 250 or EL VAX 260. In some embodiments, the non-softenable material may have a Shore "A" hardness of approximately 82, which can provide a durable, rubbery material.

In some embodiments, the non-softenable material can include a mixture of styrene block copolymer and high-density polyethylene (HDPE). More specifically, the styrene block copolymer may include DYNAFLEX (part number G2780-0001 from GLS Corporation, McHenry, IL) while the HDPE may include HD-6706 ESCORENE (ExxonMobile Chemical Co., Houston, TX).

In another embodiment, the non-softenable material can include a styrene block copolymer mixed with polyolefrn elastomer, which is a copolymer of ethylene and octene-1. A suitable copolymer is available as ENGAGE (Dupont Canada, Inc.,

Mississauga, Ontario).

In another embodiment, the non-softenable material can include a mixture of thermoplastic rubber and a polyolefrn elastomer as described above. Suitably

thermoplastic rubbers include, for example, SANTOPRENE (ExxonMobile Chemical Co., Houston, TX) and KBATON Thermoplastic Rubber (Kraton Polymers U.S. LLC, Houston, TX)

In other embodiments, the non-softenable material can include a thermoplastic polyurethane having a relative high melt point (e.g., greater than 180°F) and a durometer at or above 90A and/or 40D. Thermoplastic polyurethanes suitable for use as the non- softenable material include, for example, certain TEXIN thermoplastic polyurethanes (Bayer AG, Leverkusen, Germany).

In still other embodiments, the non-softenable material can include a saturated elastomeric base styrenic (SEBS) such as, for example, UNISOFT (United Soft Plastics, Inc., Lawrenceville, GA).

Unless embodiments are mutually exclusive or unless otherwise indicated, a mouthguard of the present invention can include the features of any two or more embodiments described herein.

For any method disclosed herein that includes discrete steps, the steps may be conducted in any feasible order. And, as appropriate, any combination of two or more steps may be conducted simultaneously.

The complete disclosure of all patents, patent applications, and publications, and electronically available material cited herein are incorporated by reference in their entirety. In the event that any inconsistency exists between the disclosure of the present application and the disclosure(s) of any document incorporated herein by reference, the disclosure of the present application shall govern.

The foregoing detailed description and drawings have been given for clarity of understanding only and represent merely exemplary embodiments. Thus, no unnecessary limitations are to be understood from the description and drawings. The invention is not limited to the exact details shown and described, for variations obvious to one skilled in the art will be included within the invention defined by the claims.

Unless otherwise indicated, all numbers expressing quantities of components, molecular weights, and so forth used in the specification and claims are to be

understood as being modified in all instances by the term "about." Accordingly, unless otherwise indicated to the contrary, the numerical parameters set forth in the specification and claims are approximations that may vary depending upon the desired properties sought to be obtained by the present invention. At the very least, and not as an attempt to limit the doctrine of equivalents to the scope of the claims, each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques.

Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the invention are approximations, any numerical values set forth in the specific examples are reported as precisely as possible. All numerical values, however, inherently contain a range necessarily resulting from the standard deviation found in their respective testing measurements.

All headings are for the convenience of the reader and should not be used to limit the meaning of the text that follows the heading, unless so specified.