阅读说明：本技术 蜡基组合物，其制品及制造和使用方法 (Wax-based compositions, articles thereof, and methods of making and using ) 是由 S·B·约翰逊 D·L·马盖茨 B·L·霍布森 J·D·斯考唯尔 N·T·杰索普 P·M· 于 2014-03-07 设计创作，主要内容包括：用于制备在口腔治疗装置中使用的阻隔层的蜡基组合物在形成平坦片或三维制品时对至少45℃的温度热稳定,并且在室温(25℃)下是可塑性变形的。蜡基组合物包含与聚合物部分均匀混合的蜡部分。蜡部分包含至少一种蜡并且聚合物部分包含至少一种聚合物,经选择使得当至少一种蜡和至少一种聚合物均匀混合在一起时,它们产生具有所需热稳定性和塑性变形性质的蜡基组合物。在没有外部支持的情况下,由这类蜡基组合物制成的口腔治疗装置中的阻隔层对至少40℃的温度是尺寸上稳定的。并且可在使用者嘴中可塑性变形以至少部分对使用者的独特齿列的尺寸和形状进行定制。(The wax-based composition used to prepare the barrier layer for use in the oral treatment device is thermally stable to temperatures of at least 45 ℃ when formed into a flat sheet or three-dimensional article, and is plastically deformable at room temperature (25 ℃). The wax-based composition comprises a wax portion homogeneously mixed with a polymer portion. The wax portion comprises at least one wax and the polymer portion comprises at least one polymer, selected such that when the at least one wax and the at least one polymer are homogeneously mixed together they produce a wax-based composition having the desired thermal stability and plastic deformation properties. The barrier layer in an oral treatment device made from such wax-based compositions is dimensionally stable to temperatures of at least 40 ℃ without external support. And is plastically deformable in the user's mouth to at least partially customize the size and shape of the user's unique dentition.)

1. A dental tray, comprising:

a composition comprising greater than 40% and up to about 95% by weight of a wax component and a thermoplastic elastomer admixed with the wax component,

wherein the composition is formed into a barrier layer.

2. The tray of claim 1, wherein the wax component comprises paraffin wax.

3. The dental tray of claim 1, wherein the wax component comprises a microcrystalline wax.

4. The tray of claim 1, wherein the tray is thermally stable to a temperature of at least 45 ℃.

5. The tray of claim 1, wherein the tray comprises at least one side wall and a bottom wall adjacent to and extending laterally from the at least one side wall.

6. The tray of claim 1, wherein the tray comprises at least one area having a thickness of about 0.1mm to about 0.5 mm.

7. The tray of claim 1, wherein said wax component is substantially homogeneously mixed with said thermoplastic elastomer.

8. The tray of claim 1, wherein the thermoplastic elastomer comprises from about 5% to less than 60% by weight of the composition.

9. A dental tray according to claim 1, wherein the wax component comprises from about 50% to about 93% by weight of the composition and the thermoplastic elastomer comprises from about 7% to about 50% by weight of the wax-based composition.

10. The tray of claim 1, wherein said thermoplastic elastomer component comprises a polyolefin.

11. The dental tray of claim 1, further comprising a dental treatment composition adjacent to or impregnated into the barrier layer.

12. A dental treatment apparatus, comprising:

a strand formed from a composition comprising a wax component and a thermoplastic elastomer component, wherein the wax component comprises greater than 40% and up to about 95% by weight of the composition; and

a dental treatment composition adjacent to or impregnated into the strip.

13. The dental treatment apparatus of claim 12, wherein the wax component comprises at least one of a paraffin wax or a microcrystalline wax.

14. A dental treatment apparatus as in claim 12, wherein the strip is initially flat and sufficiently flexible to be placed over at least a portion of a user's teeth.

15. A dental treatment apparatus as in claim 12, wherein the thermoplastic elastomer component comprises a polyolefin.

16. A dental treatment apparatus as in claim 12, wherein the dental treatment composition comprises a dental bleaching agent.

17. A method of manufacturing a dental treatment device, comprising:

mixing a wax component and a thermoplastic elastomer component to form a composition comprising greater than 40 wt% of the wax component; and is

Forming the composition into a dental treatment tray or strip that is cut and disposed to be placed over at least a portion of a user's teeth.

18. The method of claim 17, wherein the wax component comprises at least one of a paraffin wax or a microcrystalline wax.

19. The method of claim 17, wherein the forming comprises injection molding and thermoforming the wax-based composition into a dental treatment tray or strip.

20. The method of claim 19, further comprising disposing a dental treatment composition on at least one region of the dental treatment tray or strip.

1. Field of the invention

The present invention relates to the field of wax-based compositions and dental treatment devices, as well as other articles made from such compositions.

Background

Disclosure of Invention

Disclosed herein are wax-based compositions suitable for use in the preparation of thermally stable and plastically deformable sheets or articles. The wax portion of the exemplary wax-based composition comprises at least one wax and the polymer portion comprises at least one polymer and is homogeneously mixed with the wax portion. According to one embodiment, the wax-based composition is plastically deformable at room temperature (25 ℃) and is thermally stable to a temperature of at least 40 ℃, or at least about 42.5 ℃, or at least about 45 ℃, or at least about 48 ℃, or at least about 50 ℃, or at least about 52.5 ℃, or at least about 55 ℃, or at least about 60 ℃, or at least about 65 ℃, or at least about 70 ℃ when formed into a flat sheet or three-dimensional article.

Also disclosed is a method of making a wax-based composition suitable for use in preparing a thermally stable and plastically deformable sheet or article, the method comprising: (1) combining at least one wax and at least one polymer to form a mixture; and (2) processing the mixture to form the following wax-based composition: (a) which comprises a wax moiety homogeneously mixed with a polymer moiety, (b) is thermally stable to a temperature of at least 45 ℃ when formed into a flat sheet or three-dimensional article, and (c) is plastically deformable at room temperature (25 ℃).

The flat sheets and three-dimensional articles made from the wax-based compositions disclosed herein can be used for any desired purpose, one example of which is as a barrier layer forming part on an oral treatment device. According to one embodiment, the barrier layer may be in the form of a dental treatment tray having at least one side wall and at least one bottom wall extending laterally from the at least one side wall. According to another embodiment, the barrier layer may be in the form of a strip. The oral treatment composition in the oral treatment device comprises one or more active agents for providing the desired oral treatment.

According to one embodiment, the barrier layer made from the wax-based composition is non-customized and does not contain features corresponding to the user's unique dentition. Due to the unique properties of the wax-based compositions disclosed herein, the barrier may be at least partially customizable when placed in a user's mouth and heated to body temperature to at least partially conform to the user's unique dentition, particularly the occlusal surface. In this manner, the oral treatment device may be self-customized by the user during use. This eliminates the need to first perform a customization process to obtain a device that closely conforms to the user's unique dentition to function as an at least partially customized oral treatment device prior to placing the oral treatment composition adjacent to the barrier layer. And where the wax-based combination forming the barrier layer is not resilient but is plastically deformable, the barrier layer is less likely to fall off the user's teeth once the tray is fitted to the user's teeth, which often occurs in the case of a flexible barrier layer made of a resilient and/or flexible material.

These and other advantages and features of the invention will be more fully understood from the following description and appended claims, or may be learned by the practice of the invention as set forth hereinafter.

Drawings

To further clarify the above and other advantages and features of the present invention, a more particular description of the invention will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. The invention will be described and illustrated with additional specificity and detail through the use of the accompanying drawings in which:

FIGS. 1A-1B illustrate an exemplary oral treatment device comprising a dental treatment tray and a gel or solid oral treatment composition within the tray;

FIGS. 2A-2B illustrate an exemplary oral treatment device comprising a dental treatment tray having features that aid in conforming the treatment device to the shape of a user's dental arch and a gel or solid oral treatment composition within the tray;

3A-3B illustrate an exemplary oral treatment device comprising a dental treatment tray having an incision or discontinuity that assists the treatment device in conforming to the shape of a user's dental arch and a gel or solid oral treatment composition within the tray;

4A-4B illustrate an oral treatment device contained within a sealed protective package having a peelable lid;

figures 5A-5B show an oral treatment device comprising a barrier layer in the form of an initially flat strip coated with an oral treatment composition;

figures 6A-6B illustrate an oral treatment strip that wraps around and closely conforms to the shape of a user's teeth due to the highly conformable nature of the wax-based barrier layer and the adhesive nature of the oral treatment composition;

figures 7A-7E illustrate various shapes of strip-like barrier layers that may be used to finish an oral treatment device according to the present invention.

Detailed description of the preferred embodiments

I. Introduction to the design reside in

Disclosed herein are wax-based compositions formed from a wax component and a polymer component to be both thermally stable and plastically deformable. Because the wax-based composition is thermally stable, articles made therefrom are capable of retaining their shape without significant deformation (i.e., are dimensionally stable) in the absence of external forces when heated to temperatures to which such articles may be exposed. Since the wax-based composition is plastically deformable, the article thus made can be plastically deformed by applying a deforming force.

Also disclosed are methods of making wax-based compositions from one or more types of waxes, one or more types of polymers, and optionally one or more auxiliary components to have desired material and/or mechanical properties. One or more types of waxes and one or more types of polymers may be mixed together homogeneously to form a wax-based composition containing a wax portion and a polymer portion. Heat and/or pressure may be applied to produce a wax-based composition having desired material and/or mechanical properties.

Exemplary articles that can be made from the wax-based compositions as described herein include sheets and three-dimensional forms. The sheets and three-dimensional articles may be thermally stable and plastically deformable. The sheet can be used for any desired purpose, examples of which include use as a barrier layer in an oral treatment strip for applying an oral treatment composition to the teeth and/or gums of a user, use as an intermediate substrate thermoformed into a dental treatment tray, and use as a lid for reversibly sealing the aperture of a container. Examples of three-dimensional articles that can be used include dental treatment trays such as those made by injection molding a wax-based composition or thermoforming a wax-based sheet.

An oral treatment device is one example of a particular application of an exemplary article made from the wax-based composition described herein. The oral treatment device can include a barrier layer, such as a strip or tray, and one or more oral treatment compositions adjacent to and/or impregnated into the barrier layer. An exemplary oral treatment strip includes an initially flat wax substrate and includes an oral treatment composition adjacent to and/or impregnated into the sheet. The oral treatment strip may be placed over or wrapped around at least a portion of a user's teeth. Another example of an oral treatment device includes a pre-manufactured dental treatment device formed from a wax-based composition and an oral treatment composition disposed and/or impregnated within a dental treatment tray. The preformed dental treatment tray facilitates easier placement of the oral treatment device on a person's teeth than does the oral treatment strip.

According to one embodiment, the oral treatment device includes a barrier layer that is initially non-customized and does not contain features corresponding to a user's unique dentition, but that can accommodate a person's teeth during use. According to one embodiment, the barrier layer is at least partially customizable when heated to body temperature and a forming force is applied, such as suction, bite and/or finger pressure. In this way, a self-customizable oral treatment device is provided that can be self-customized in the user's mouth after the oral treatment composition is placed on or in the barrier layer. This greatly facilitates oral treatment as it provides a comfortable fit custom device that can be made during oral treatment. This eliminates the cumbersome customization process and time delays typically involved in preparing custom dental trays, whether from stone molds or "bite" of the user's teeth. Heretofore, customization has required customization prior to application of the oral treatment composition on or in a customized dental tray. The ability of an oral treatment device already containing a treatment composition to self-customize in a user's mouth is surprising and unexpected, further enhancing the uniqueness and creativity of the wax-based compositions described herein.

Also provided are kits utilizing a barrier layer made from the wax-based compositions described herein and an oral treatment device comprising a barrier layer and one or more oral treatment compositions adjacent to or impregnated within the barrier layer. The kit may comprise a multiple oral treatment device comprising a barrier layer and one or more pre-applied oral treatment compositions. Alternatively, the kit may include one or more oral treatment devices comprising a barrier layer and one or more oral treatment compositions that can be applied to the barrier layer by a user.

The method of providing treatment to the teeth and/or gums of a user utilizes a barrier layer made from the wax-based composition described herein and one or more oral treatment compositions that have been previously applied or can be applied to it by the user at the time of use. According to one embodiment, the user places an oral treatment device comprising a wax-based barrier layer and an oral treatment composition in the user's mouth and then plastically deforms the wax-based barrier layer to better conform to the user's unique dentition to provide better fit and comfort. As described herein, the oral treatment device is self-customizing by the user, such as by warming the wax-based barrier layer to body temperature in the user's mouth and applying a force to plastically deform the barrier layer to at least partially customize the barrier layer to include indentations that conform to the user's unique dentition.

Wax-based compositions

The wax-based compositions described herein include a wax portion, a polymer portion intimately mixed with the wax portion, and optionally one or more auxiliary components. Examples of waxes that may be used include petroleum waxes, distilled waxes, synthetic waxes, mineral waxes, vegetable waxes, and animal waxes. Examples of polymers that can be used include synthetic polymers and natural polymers. Examples of auxiliary components include plasticizers, rheology modifiers and fillers.

Examples of petroleum waxes include paraffin waxes (made from long chain alkanes) (e.g., IGI 1260A), intermediate waxes (a mixture of long chain and branched alkanes), microcrystalline waxes (branched alkanes of higher molecular weight and more amorphous than paraffin waxes) (e.g., IGI 5909A), distillate waxes (e.g.,examples of synthetic waxes include polyethylene waxes (based on polyethylene), Fischer-Tropsch waxes (Fischer-Tropsch wax) (made from syngas), chemically modified waxes (which are typically esterified or saponified), substituted amide waxes and polymerized α -olefins mineral waxes include pure ozokerite, montan waxes (extracted from lignite and brown coal), ozokerite (found in lignite seams), and peat waxes.examples of vegetable waxes include bayberry waxes (from bayberry shrubs (bayberry shrubs), fire tree (Myrica faya) fruit surface waxes), candesa wax (delissa wax) (from esparto cornus (Euphorbia), carnauba wax (carnauba wax), carnauba wax (from carnauba wax), carnauba wax (carnauba), carnauba wax (carnauba wax), carnauba wax (carnauba wax), carnauba wax (carnauba wax), carnauba wax (wax), carnauba wax (wax), and,from the sebaceous glands of sheep) and shellac wax (from the gecko (Kerria lacca)).

Mixtures of waxes can be used to integrate material properties from different waxes. For example, paraffin waxes, intermediate waxes, and/or microcrystalline waxes may be mixed to provide a desired level of plastic deformation at room temperature and dimensional stability at higher temperatures. Paraffin, intermediate wax and microcrystalline wax of formula C_nH_2n+2Of a fully saturated hydrocarbon mixture. Paraffin waxes comprise primarily straight chain paraffins, microcrystalline waxes comprise primarily branched chain paraffins of higher molecular weight than the paraffins in the paraffin wax, and intermediate waxes have compositions and properties that are intermediate between paraffin waxes and microcrystalline waxes. The effect of branching is to lower the melting point and increase the viscosity. Typically, paraffin waxes mostly comprise linear C18 to C40 alkanes, intermediate waxes have increased branching and mostly comprise C25 to C60 alkanes, and microcrystalline waxes contain little or no linear alkanes, but rather complex branched C25 to C85 alkanes.

As a general rule, the properties of paraffin and microcrystalline waxes can be summarized as follows:

the one or more waxes comprising the wax portion of the wax-based composition described herein typically comprise an amount of from about 40% to about 95%, preferably from about 50% to about 93%, more preferably from about 60% to about 90%, and most preferably from about 70% to about 85% by weight of the wax-based composition.

The polymer portion may include at least one type of polymer, examples of which include one or more polymers selected from the group consisting of: polyolefins, polyesters, polyurethanes, thermoplastic elastomers, thermoset elastomers, and mixtures thereof. Examples of polyolefins include polyethylene (including High Density Polyethylene (HDPE), Low Density Polyethylene (LDPE) or Ultra Low Density Polyethylene (ULDPE)), polypropylene (PP), and Polytetrafluoroethylene (PTFE) (e.g., TEFLON (TEFLON)), thermoplastic polyolefins(e.g., thermoplastic polyethylene, thermoplastic polypropylene, thermoplastic olefins), and propylene-based elastomers. Other synthetic polymers include ethylene vinyl acetate copolymer (EVA), ethylene vinyl alcohol copolymer (EVAL), polyvinyl acetate, polyvinyl alcohol, polyesters (such as polyethylene terephthalate or PETE), polycarbonate, methacrylate, acrylates, polyamides (e.g., nylon), polyurethanes, polyvinyl chloride (PVC), synthetic rubbers, phenolic resins (bakelite), neoprene, polystyrene, polyacrylonitrile, PVB, silicone elastomers, and thermoplastic elastomers (e.g., olefin-based elastomers such as ethylene-based, propylene-based, or butylene-based elastomers) (e.g., Engage @)^TMThermoplastic elastomer, Vistamaxx^TMThermoplastic elastomers, e.g. Vistamaxx^TM6102、Vistamaxx^TM6202 and Vistamaxx^TM3020、

DGR 6250CL andm TM6 LFT). Natural polymeric materials include shellac, natural rubber, polysaccharides, cellulose ethers, cellulose acetates and proteins.

According to one embodiment, the polymer portion may have high peroxide stability (i.e., not result in decomposition of the peroxide bleaching agent) and/or good thermal stability (i.e., produce a strip or tray that retains its shape when exposed to elevated temperatures during shipping and storage).

The amount of the one or more polymers comprising the polymer portion of the wax-based composition described herein typically comprises from about 5% to about 60%, preferably from about 7% to about 50%, more preferably from about 10% to about 40%, and most preferably from about 15% to about 30% by weight of the wax-based composition.

When included, one or more auxiliary components (e.g., plasticizers, rheology modifiers, and/or fillers) are included in an amount of from about 0.01% to about 5%, preferably from about 0.1% to about 4%, and more preferably from about 1% to about 3% by weight of the wax-based composition.

At least a portion of the wax fraction, the polymer fraction and/or the auxiliary component may be reacted withThe materials contained in (a) are similar to or provided by,sold in tablet form and contains a proprietary mixture of wax and polyolefin.M is a flexible sheet material with a paper backing layer that is self-adhesive in the form of a film and is commonly used in temporarily sealed flasks or cuvettes in chemical laboratories.

F is commonly used for plant grafting.

The sheet typically softens at about 100F (or about 38℃) and if soThe sheet is thermoformed into a dental treatment tray, which then begins to hang at a temperature of about 38 ℃ or higher. As a result, natural materials are used at elevated temperatures (i.e., up to 50℃. or higher) during shipping and storageThe oral treatment strip made as a barrier layer may become wrinkled or crinkled. In addition, natural substances are usedThe oral treatment strip made as a barrier layer can become too soft and sticky over extended periods of time in the mouth and upon exposure to body temperature, making it easy for the user to bite through

A barrier layer, reducing its ability to block saliva.

However, surprisingly, whenWhen the sheet material is cut into pieces and used as a feed in an injection molding process, the resulting injection molded tray is thermally stable to temperatures in excess of 40 ℃ (e.g., up to about 50-52 ℃, depending on the injection molding conditions). Thus, "natural"The compositions of (a) are converted to new compositions of matter, such as those described herein, when subjected to temperatures and/or pressures associated with injection molding processes. In addition, the first and second substrates are,can be used as a mixing component with other components described herein to produce a dental tray or strip having thermal stability at a temperature of at least 40 ℃.

According to several embodiments, the wax-based composition is thermally stable (i.e., dimensionally stable and resistant to significant deformation) at temperatures to which the sheet or article is typically subjected during transport and storage when formed into a flat sheet or three-dimensional article and heated. According to one embodiment, the wax-based composition is thermally stable upon heating to a temperature of at least 40 ℃, or at least about 42.5 ℃, or at least about 45 ℃, or at least about 48 ℃, or at least about 50 ℃, or at least about 52.5 ℃, or at least about 55 ℃, or at least about 60 ℃, or at least about 65 ℃, or at least about 70 ℃.

Additionally, the wax-based composition may be plastically deformable. That is, the composition can be formed into a desired shape and then maintain that shape without the application of external forces. According to one embodiment, the wax-based composition is plastically deformable and not brittle at room temperature (25 ℃). In other words, the wax-based composition can be configured into a desired shape without breaking or cracking, and retains that shape when not heated above room temperature. In other embodiments, the wax-based composition becomes plastically deformable at room temperature when extruded into a sheet or thermoformed or injection molded into a desired three-dimensional article of a particular thickness at elevated temperatures. In some embodiments, in the case of an oral treatment device comprising a wax-based barrier layer, the wax-based composition is semi-rigid at room temperature and becomes more flexible and deformable when heated above room temperature (e.g., body temperature).

Depending on the relative concentrations of the wax portion and the polymer portion, the wax portion may comprise a continuous phase and the polymer portion may comprise a dispersed phase within the continuous wax phase. Alternatively, the polymer portion may comprise a continuous phase and the wax portion may comprise a dispersed phase within the continuous wax phase. In some cases, the wax portion and the polymer portion may form an interpenetrating network without the continuous and dispersed phases.

An exemplary method of making a wax-based composition suitable for use in making a thermally stable and plastically deformable sheet or article comprises: (1) combining at least one wax and at least one polymer to form a mixture; and (2) processing the mixture to form a wax-based composition comprising a wax moiety homogeneously mixed with a polymer moiety.

According to one embodiment, the at least one type of wax and the at least one type of polymer are combined and processed using an extruder (e.g., a single screw or twin screw extruder). The extruder may form the wax-based composition into the form of a sheet having a desired thickness. The sheet can be used directly or further shaped (e.g., thermoformed) into the desired shape of the article (e.g., dental treatment tray). Alternatively, the extruder may form the wax-based composition into a chain that is cut into individual pellets, which may then be further processed, such as by injection molding, into the desired shape of the article. Other mixing devices known in the art may be used to form the wax-polymer mixture, which is then extruded, injection molded, or otherwise formed into the desired shape.

An exemplary extruder can include a plurality of zones (e.g., 10 zones), such as a mixing zone, a heating zone, and an extrusion zone. The wax, polymer and auxiliary material may be fed separately into the extruder in different zones or fed together in the same zone. For example, one or more polymer components may be fed to zone 1, while one or more wax components may be fed to zone 3. If used, the auxiliary component may be fed to these zones or to different zones. These zones may have similar or different temperatures. Generally, the materials fed to and mixed in the extruder may be subjected to one or more temperatures in the range of from about 50 ℃ to about 225 ℃, preferably from about 55 ℃ to about 210 ℃. More preferably, the material in the prior zone may be subjected to a higher temperature in the range of about 135 ℃ to about 220 ℃ and a lower temperature in the range of about 50 ℃ to about 125 ℃ in the subsequent zone in another portion of the extruder, most preferably a higher temperature in the range of about 140 ℃ to about 210 ℃ in the prior zone and a lower temperature in the range of about 55 ℃ to about 120 ℃ in the subsequent zone. The pressure within the extruder may be up to about 1000psi, preferably up to about 100psi, more preferably up to about 50psi, and most preferably in the range of about 1 to about 25 psi.

An exemplary injection molding apparatus includes a hopper, a barrel with a screw feeder, an injection nozzle, a valve, a mold cavity, and a mold core. During injection molding, the wax-based composition may be subjected to one or more initial temperatures for melting or softening the composition in the range of 40 ℃ to about 200 ℃, preferably about 45 ℃ to about 150 ℃, and more preferably about 50 ℃ to about 120 ℃. The feeder barrel may have multiple heating zones with increasing temperatures. Typically, the highest temperature is reached at the valve. The softened or melted composition is introduced into the mold cavity under pressure to fill the mold cavity, such as at a pressure in the range of from about 1000psi to about 50,000psi, preferably from about 2500psi to about 40,000psi, more preferably from about 5000psi to about 30,000psi, more preferably from about 7500psi to about 20,000psi, and most preferably from about 10,000psi to about 15,000 psi. To produce a cured injection molded article, the mold core and mold cavity may have a reduced temperature in the range of about-10 ℃ to about 40 ℃, preferably about-5 ℃ to about 30 ℃, more preferably about 0 ℃ to about 25 ℃, more preferably about 2 ℃ to about 20 ℃, and most preferably about 3 ℃ to about 10 ℃.

Articles made from wax-based compositions

Examples of articles that can be made from the wax-based compositions described herein include, but are not limited to, sheets, oral treatment strips, sheets for sealing apertures, molded three-dimensional articles, and dental treatment trays. The sheet-like article may be flat and flexible and plastically deformable to be capable of being placed over and then wrapped around an object into a desired configuration capable of maintaining its shape. In some cases, the sheets are "customizable" to include three-dimensional features around the wrapped object. Similarly, the molded three-dimensional article can be plastically deformed to enable placement on the object and then conformed to better conform to the object and to better conform to the three-dimensional features surrounding the conformed object.

According to several embodiments, a flat or curved sheet is provided that is plastically deformable at room temperature (25 ℃) and heat stable to a temperature of at least 40 ℃, or at least about 42.5 ℃, or at least about 45 ℃, or at least about 48 ℃, or at least about 50 ℃, or at least about 52.5 ℃, or at least about 55 ℃, or at least about 60 ℃, or at least about 65 ℃, or at least about 70 ℃ (e.g., depending on the formulation at a temperature of 50-75 ℃). This allows sheet-like articles made from the wax-based compositions described herein to be manufactured, shipped and stored at temperatures of 50-75 deg.C or higher without losing their desired shape. The sheet comprises a wax-based composition comprising a wax portion and a polymer portion homogeneously mixed with the wax portion. The wax portion comprises at least one wax. The polymer portion comprises at least one polymer. The sheet may be formed by extruding the wax-based composition.

According to other embodiments, a three-dimensional article is provided that is plastically deformable at room temperature (25 ℃) and thermally stable to a temperature of at least 40 ℃, or at least about 42.5 ℃, or at least about 45 ℃, or at least about 48 ℃, or at least about 50 ℃, or at least about 52.5 ℃, or at least about 55 ℃, or at least about 60 ℃, or at least about 65 ℃, or at least about 70 ℃ (e.g., at a temperature of 50-75 ℃ depending on the formulation) and thus dimensionally stable at elevated temperatures.

Oral treatment device and kit

Disclosed herein are oral treatment devices comprising a wax-based composition and an oral treatment composition adjacently disposed and/or impregnated into a barrier layer. The barrier layer may be in the form of a dental tray or strip. Dental treatment trays generally include at least one side wall (e.g., at least one lip side wall and optionally one tongue side wall) and a bottom wall adjacent to and extending laterally from the at least one side wall (e.g., extending from the lip side wall to the tongue side wall or forming a transition or bridge between the lip side wall and the tongue side wall). At least one of the side walls and the bottom wall of the strip-shaped barrier and/or the dental treatment tray comprises a wax-based composition comprising at least one wax and at least one polymer homogeneously mixed with the wax. The oral treatment device can be formed by thermoforming a wax-based sheet, injection molding a wax-based composition, or any other suitable method known in the art.

According to several embodiments, an oral treatment device made from the wax-based composition described herein is plastically deformable at room temperature (25 ℃) and is thermally stable to a temperature of at least 40 ℃, or at least about 42.5 ℃, or at least about 45 ℃, or at least about 47.5 ℃, or at least about 50 ℃, or at least about 53 ℃, or at least about 55 ℃, or at least about 60 ℃, or at least about 65 ℃, or at least about 70 ℃ (e.g., at a temperature of 50-75 ℃ depending on the formulation) and thus dimensionally stable at elevated temperatures. This allows the oral treatment devices made from the wax-based compositions described herein to be manufactured, shipped and stored at temperatures of 50-75 ℃ or higher without losing their desired shape. However, dental treatment trays and strip-like barrier layers made from the wax-based compositions described herein can readily conform to the size and shape of a user's unique dentition (e.g., are self-customizable in a user's mouth) when placed in the user's mouth. They can easily conform to the occlusal surface but prevent perforation because they do not soften excessively at body temperature.

According to one embodiment, the tray or strip is non-customized and does not contain features corresponding to the user's unique dentition. Once placed in the user's mouth, the tray or strip may warm to body temperature, which facilitates the ability of the tray or strip to at least partially conform to the user's unique dentition and thereby become at least partially customized. For example, the tray or strip may be at least partially customized in the user's mouth using shaping forces, such as suction, bite and/or finger pressure. According to another embodiment, the tray may be customized (e.g., using a stone mold of the user's teeth to register depressions in the tray corresponding to the user's unique dentition). The oral strip and tray are preferably prepared so that it is difficult or impossible for the user to bite through the tray or occlusal surface of the strip to maintain a barrier to saliva.

A kit for providing oral treatment may comprise a multiple oral treatment device comprising a wax-based barrier layer and one or more pre-applied oral treatment compositions. Alternatively, the kit may comprise one or more wax-based barrier layers and one or more oral treatment compositions, which may be applied to the barrier layer by the user at the time of use. The kit may include some barrier layers configured to fit the upper teeth of the person and other barrier layers configured to fit the lower teeth of the person.

Alternatively, a plurality of single-use, disposable, custom-made dental treatment trays made from the wax-based compositions described herein can be provided to a user in a kit. According to one embodiment, a kit of customized dental treatment trays allows a user to benefit from having a new customized dental tray at each treatment event. Furthermore, due to the plastically deformable nature of the wax-based composition, the dental tray made therefrom may be more comfortable and better fit than a custom fit dental tray.

A method of manufacturing a single use, disposable custom dental treatment tray kit, the method comprising: (1) taking an impression of a user's teeth using an impression material; (2) preparing a stone mold of a user's teeth from an impression of the user's teeth; (3) providing a plurality of sheets comprised of the wax-based composition described herein; (4) thermoforming the sheet using a stone mold to form a plurality of customized dental treatment trays; and (5) optionally trimming away excess tray material to maximize proper size and fit. Single-use disposable custom wax-based dental treatment trays can be used in kits that contain oral treatment compositions that are loaded into the tray by the user or they can be preloaded with oral treatment compositions.

Regardless of its form, the barrier layer is typically waterproof to protect the oral treatment composition from contact with saliva in the user's mouth. Since waxes and polymers tend to be hydrophobic, the wax-based compositions described herein will typically be water-resistant. The wax-based barrier layer typically has a thickness ranging from about 0.025mm to about 1.5mm, or from about 0.05mm to about 1.25mm, or from about 0.075mm to about 1mm, or from about 0.09mm to about 0.75mm, or from about 0.1mm to about 0.5mm, or from about 0.15mm to about 0.35 mm.

According to one embodiment, the occlusal wall of the exemplary dental treatment tray may have a greater cross-sectional thickness (e.g., about 20-100%, or about 30-75%, or about 40-60% thicker) than the one or more side walls. This provides a number of benefits, including the ability of the dental treatment tray to self-customize the user's teeth without the user biting through the occlusal wall. The dimensional stability of the dental treatment tray may also be improved by providing one or more sidewalls with a more rigid base connected to the one or more sidewalls without reducing comfort and fit. The occlusal wall is typically the last wall to contact the user's teeth during installation, such that an increase in the rigidity of the occlusal wall does not significantly reduce the ability of the thinner sidewall to customize or conform to the tooth surface on the labial and/or lingual side of the user's mouth. In addition, since the occlusal wall is easily self-customized to the user's occlusal tooth surfaces by occlusion, the user may easily self-customize the occlusal wall despite the increased thickness. And in fact, the increased thickness is most beneficial in the bite area, which experiences the greatest customized force (i.e., bite).

Another benefit of providing a thickened occlusal wall is that it facilitates injection molding of thinner walled dental treatment trays from the wax-based compositions described herein. Since the occlusal walls of the molded tray are generally intermediate the lip and tongue sidewalls, the mold cavity in the area corresponding to the thickened occlusal walls will be wider than the adjacent areas corresponding to the thinner lip and tongue sidewalls. The wider mold cavity in the middle region of the mold facilitates injection molding by allowing the softened wax-based composition to better flow through the mold cavity.

The oral treatment composition may comprise at least one active agent, at least one tissue-binding (or thickening) agent, a liquid or gel solvent, a vehicle or carrier in which the active agent and tissue-binding agent are dispersed, and other desired components and adjuvants. The therapeutic composition can comprise a continuous or non-continuous bead or layer positioned to contact at least a portion of a human tooth surface and/or gum. The therapeutic composition may have the consistency of a liquid, gel, viscous gel, putty, or solid. Solids and putties are more sticky and adhesive to teeth and/or gums when moistened with water or saliva. In some cases, the primary difference between "gel" and "putty" or "solids" is the level of solvent or carrier within the composition. Generally, the greater the concentration of solvent or vehicle relative to the tissue adhesive, the lower the viscosity of the composition. The lower the concentration of solvent or carrier relative to the tissue adhesive, the more viscous the composition, the more putty-like or solid-like.

Examples of active agents of the oral treatment composition include oral bleaching agents, desensitizing agents, remineralizing agents, antimicrobial agents, antiplaque agents, antitartar agents, gingival soothing agents, anesthetics, antioxidants, and mouth freshening agents. Examples of dental bleaching agents include aqueous hydrogen peroxide, urea peroxide, metal perborates (e.g., sodium perborate), metal percarbonates (e.g., sodium percarbonate), metal peroxides (e.g., calcium peroxide), metal chlorides and hypochlorites, peroxyacids (e.g., peroxyacetic acid), and peroxyacid salts.

The bleaching agent in the dental bleaching composition of the present invention may be present in any desired concentration, for example, from 1 to 90% by weight of the dental bleaching composition. The concentration of the dental bleaching agent can be adjusted according to the expected treatment time of each bleaching period. The bleaching agent is preferably included in an amount of from about 1% to about 60% by weight, more preferably from about 3% to about 40% by weight, and most preferably from about 5% to about 30% by weight. When dental bleaching agents are used, the materials used to prepare the wax-based composition may be selected so as not to prematurely react with and destabilize the bleaching agent.

Examples of desensitizing agents include potassium nitrate, other potassium salts, citric acid, citrate salts, and sodium fluoride. Examples of remineralizing agents are sodium fluoride, stannous fluoride, sodium monofluorophosphate and other fluoride salts. Examples of antimicrobial agents and preservatives include chlorhexidine, triclosan, sodium benzoate, parabens, tetracycline, phenols, cetyl pyridinium chloride, and benzalkonium chloride. An example of an antiplaque or anticalculus agent is pyrophosphate. Examples of gum soothing agents include aloe, mild potassium nitrate and isotonic solution forming salts. Examples of anesthetics include benzocaine and lidocaine. Examples of antioxidants include vitamin a, vitamin C, vitamin E, other vitamins, and carotene. Examples of mouth fresheners include camphor, wintergreen oil, peppermint, spearmint, and methyl salicylate.

The tissue adhesive, tackifier or thickener may comprise a variety of hydrophilic polymers. Examples include polyvinylpyrrolidone (PVP), PVP-vinyl acetate copolymer, Carboxypolymethylene (CARBOPOL) (e.g., CARBOPOL sold by Novean, Inc.), polyethylene oxide (e.g., POLYOX made by Union Carbide, Union Carbide), polyacrylic acid polymers or copolymers (e.g., PEMULEN sold by novain), polyacrylates, polyacrylamides, polyacrylic acid and polyacrylamide copolymers, carboxymethylcellulose, carboxypropylcellulose, cellulose ethers, polysaccharide gums, proteins, and the like. Examples of PVP include Kollidon 30 (a polyvinylpyrrolidone polymer with a molecular weight of 50000 sold by basf), Kollidon VA 60 (a polyvinylpyrrolidone polymer with a molecular weight of 60000), and Kollidon 90F (a polyvinylpyrrolidone polymer with a molecular weight of 1300000).

Where the oral treatment composition is a gel, the amount of one or more tissue adhesives included in the treatment gel preferably ranges from about 1% to about 50% by weight, more preferably from about 3% to about 30% by weight, and most preferably from about 5% to about 20% by weight.

Where the oral treatment composition is a putty or solid, the amount of one or more tissue adhesives included in the substantially solid treatment composition preferably ranges from about 10% to about 90% by weight, more preferably from about 20% to about 80% by weight, and most preferably from about 40% to about 75% by weight.

Liquids and gels, including viscous gels, can include one or more liquids or gels, solvents, vehicles, or carriers in which the active agent, tissue adhesive, and other components are dissolved or dispersed. Examples of liquid or gel solvents, carriers, or vehicles include water, alcohols (e.g., ethanol), and polyols (e.g., glycerol, sorbitol, mannitol, other sugar alcohols, propylene glycol, 1, 3-propanediol, polyethylene glycol, polyethylene oxide, and polypropylene glycol).

For solid or hard putties, the concentration of solvent, carrier or vehicle will generally be less than for therapeutic gels. Where it is desired to convert the gel into a putty or solid composition, it may be preferred to include one or more volatile solvents (e.g., water, alcohols, acetone, and other organic solvents) that can be removed by evaporation. Even therapeutic compositions that appear to be solid may contain significant amounts of bound water (e.g., up to about 10% or more by weight of the therapeutic composition) due to the affinity of the hydrophilic polymer for water. In the case of a therapeutic composition having a highly viscous or stiff putty consistency, the composition will typically comprise a solvent, carrier or vehicle that acts as a plasticizer or emollient.

The oral treatment composition can optionally include other components as needed to produce a treatment composition having desired properties. Examples include bleach stabilizers (e.g., EDTA, salts of EDTA, citric acid and salts thereof, phosphoric acid and salts thereof, benzylphosphonic acid (salts) and salts thereof, gluconic acid and salts thereof, alkali metal pyrophosphates, alkali metal polyphosphates, and alkyl sulfates), neutralizing agents (e.g., sodium hydroxide and triethanolamine), inorganic thickeners (e.g., fumed silica), colorants, fragrances, sweeteners, and the like.

According to one embodiment, the oral treatment device may have a horseshoe-like longitudinal shaft shape and a trough with a U-shaped cross-section, as in conventional bleaching trays. Alternatively, the oral treatment device may have a barrier layer of other shapes, such as a flat strip that is rectangular or contoured to fold around or fit with the teeth of the user.

An exemplary dental treatment device 100, 100' in the form of a dental tray is shown in fig. 1A and 1B. Fig. 1A is a perspective view of an oral treatment device 100 that includes a wax-based barrier layer 102 having a front sidewall 104, a rear sidewall 106, and a horseshoe-shaped bottom wall 108 that collectively define a channel 110 having a generally U-shaped cross-section throughout the horseshoe. Disposed within the trough 110 is an oral treatment composition 112, which may be a gel, such as a viscous gel, that can assist in reliably folding the dental treatment tray over the appropriate locations of the user's teeth during use. The oral treatment composition 112 can have a consistency ranging from a gel, a viscous gel, to a solid treatment composition. The oral treatment composition 112 can be a viscous gel having a cross-sectional diameter or thickness ranging from about 1mm to about 5mm, more preferably from about 2mm to about 4 mm. The gel may be a continuous bead of the composition.

Figure 1B shows an oral treatment device 100' comprising a wax-based barrier layer 102 in the form of a dental tray having a horseshoe shape with a substantially U-shaped cross-section. The barrier layer 102 includes a front sidewall 104, a rear sidewall 106, and a bottom wall 108 that collectively define a channel 110 having a generally U-shaped cross-section. Within the trough 110 is an oral treatment composition 112' that substantially covers the inner wall rather than the composition bead. The oral treatment composition 112' can be a gel, a viscous gel, a putty, or a solid composition. Therapeutic composition 112' is preferably a hard putty or solid having a thickness ranging from about 0.2mm to about 2mm, more preferably from about 0.5mm to about 1 mm.

Fig. 2A and 2B show oral treatment devices 200, 200 'each comprising a barrier layer 202 having an anterior sidewall 204, a posterior sidewall 206, and a bottom wall 208 that collectively define a trough 210 configured with a bead 212 (fig. 2A) of a treatment composition or a continuous layer 212' (fig. 2B) of a treatment composition. In addition, the oral treatment device 200, 200' includes a first recess 214 in the anterior sidewall 204 and a second recess 216 in the posterior sidewall 206. The notches 214 and 216 assist the oral treatment device 200, 200' in conforming to various sizes and shapes of dental arches.

Figures 3A and 3B illustrate oral treatment devices 300, 300' characterized by a secondary barrier layer that better conforms to the size and shape of various dental arches. Unlike a continuous sidewall, the oral treatment device 300, 300' includes a barrier layer 302 having an anterior sidewall 304, a posterior sidewall 306, and a bottom wall 308, the bottom wall 308 interconnecting the anterior sidewall 304 and the posterior sidewall 306. The rear sidewall 306 also includes a first rear sidewall portion 306a and a second rear sidewall portion 306b, the first rear sidewall portion 306a including a first cutout or discontinuity 307, the second rear sidewall portion 306b separated from the first rear sidewall portion 306a by a second cutout or discontinuity 309. The first rear side wall portion 306a is configured to wrap around or adjacent to the inner surfaces of the human incisors and canines. Second rear side wall portion 306b is configured to wrap around or contact the inner surfaces of a person's bicuspid teeth and optionally one or more molars.

The cut or discontinuity 309 between the first and second side wall portions 306a, 306b promotes a good fit to the human incisors and canines, particularly at the junction of the canines and bicuspids. The cut or discontinuity 309 compensates for the inconsistent difference in width between the bicuspid teeth of the person adjacent second rear sidewall portion 306b and the canine teeth adjacent first rear sidewall portion 306 a. The discontinuities or cutouts 307 in the first sidewall portion 306a also assist in conforming the first sidewall portion 306a to the inner surfaces of the human incisors and canines.

Fig. 3A also shows a continuous bead 312 of oral treatment composition within the trough or interior region defined by the front sidewall 304, rear sidewall 306, and bottom wall 308. Fig. 3B also shows a substantially continuous layer 312' of an oral treatment composition within the trough or interior region defined by the front sidewall 304, the back sidewall 306, and the bottom wall 308.

To protect the oral treatment device from contamination during storage and prior to use, the treatment device may be packaged in a sealed container or package. As shown in fig. 4A and 4B, an exemplary sealed oral treatment package 400, 400 ' includes an oral treatment device 402, 402 ' (e.g., a dental treatment tray) sealed within a protective package 404, 404 '. The protective packaging 404, 404 ' includes a rigid support layer 406, 406 ' and a peelable cover 408, 408 '. When it is desired to use the oral treatment device 402, 402 ', the peelable cover 408, 408' is removed and the treatment device 402, 402 'is removed or separated from the support layer 406, 406'.

Figures 5A and 5B illustrate one embodiment of an oral treatment device in the form of a treatment strip rather than a treatment tray. The oral treatment strip 500 comprises a strip of wax-based material 502 that is initially substantially flat and may optionally have rounded corners. The strip of wax-based material 502 may be a single layer of wax-based material composed of a homogeneous mixture of wax and polymer. Coated on or impregnated into the strip of wax-based material 502 is an oral treatment composition 504. The oral treatment composition 504 may be a homogeneous substance that is uniformly and continuously coated onto the wax-based material strip 502.

Fig. 6A and 6B illustrate an oral treatment device 600 applied to and closely conforming to the surface of a tooth 602. The oral treatment device 600 may include a barrier layer in the form of a dental treatment tray or strip that wraps around the teeth 602 to form a tray-like configuration. The oral treatment device 600 also contains an oral treatment composition that is capable of providing the desired treatment to the teeth and/or gums. Although the oral treatment device 600 is shown only covering the teeth 602 and not adjacent to the soft oral tissue 604, it is within the scope of the present invention for the oral treatment device 600 to extend over the gingival margin 606 and at least partially overlap the soft oral tissue 604.

Figures 7A-7E illustrate various embodiments of strip-shaped barrier layers that may be placed over the teeth and/or gums of a user and adapted to wrap around and contact the labial and lingual surfaces of the mouth. Fig. 7A shows an embodiment of a strip 700 of wax-based material that is substantially trapezoidal in shape. The strip 700 has a first side 701, a second side 702, a third side 703 and a fourth side 704. The first side 701 and the second side 702 are generally straight sides that slope inward from the fourth side 704 toward the third side 703. The third side 703 may be convex and shorter than the fourth side 704, while the fourth side 704 may be convex. In use, the fourth side 704 may be placed alongside the gingival margin at the intersection between the user's teeth and gums. A fold line 705 may be included in the strip 700 that extends from the first side 701 to the second side 702. The fold line 705 may be located closer to the third 703 or fourth 704 sides depending on the size and shape of the device when folded during use. The fold line 705 may be determined by the size of the user's teeth and the manner in which the oral treatment strip is placed on the user's teeth. After the strip 700 is folded along fold line 705, the third side 703 will be located next to the lingual surface of the user's teeth.

Fig. 7B shows another embodiment of a strip 720 of wax-based material that is substantially trapezoidal in shape, with stepped sides. The bar 720 has a first side 721, a second side 722, a third side 723, and a fourth side 724. The third side 723 may be convex and shorter than the fourth side 724. The fourth side 724 may be convex. The first side 721 and the second side 722 are both stepped sides that include interior corners 726 and 727, respectively. The fold line 725 generally extends between the inner corners 726 and 727 of the steps of the first side 721 and the second side 722, respectively.

Fig. 7C shows an alternative embodiment of a strip 730 of wax-based material that is substantially rectangular in shape with stepped sides. The bar 730 includes a first side 731, a second side 732, a third side 733, and a fourth side 734. The first and second sides 731, 732 are stepped side edges that include inner corners 726, 727, respectively. A fold line 735 extends from inner corners 736 and 737 of the steps of the first and second sides 731 and 732, respectively. The fold line 735 may be placed on the occlusal surfaces of the user's teeth, which wraps the strip 700 around or over the labial and lingual surfaces of the user's teeth. The strip 700 may be placed so that the user's two canine teeth are just outside of the angles 736 and 737. The fourth side 734 may be located near a gingival margin of an anterior side of the user's teeth. The third side 733 would be located along a tongue side surface of the user's teeth.

Fig. 7D shows an alternative embodiment of a strip 740 of wax-based material that is substantially rectangular in shape but has notched sides. The strip 740 has a first side 741, a second side 742, a third side 743, and a fourth side 744. The third 743 and fourth 744 sides are both substantially straight sides and may be the same length. First side 741 and second side 742 include notches 746 and 747, respectively, which allow the occlusal surfaces of the user's canine teeth to be uncovered when strip 740 is placed over the user's teeth. The fold line 745 may extend from the notch 746 of the first side 741 to the notch 747 of the second side 742. Notches 746, 747 may have a side V-shape as shown. However, these notches can be any desired shape, including rectangular, square, semi-circular, oval, etc., and such that the cusps of the canine teeth are not covered by the strip 740 when rubbed against the user's teeth.

Fig. 7E shows an alternative embodiment of a strip of wax-based material 750 that is substantially rectangular in shape, but with a fold line 755 between the side edges 756 and 757 to facilitate folding around the biting edges of the user's teeth during installation.

V. examples

The following are examples of wax-based compositions that may be used to manufacture oral treatment devices, including dental treatment trays and strip-like barrier layers. Exemplary formulations and manufacturing conditions are given by way of example and not limitation. All percentages are by weight unless otherwise indicated.

Comparative example

Heating the sheet to a softening temperature and then vacuum forming the softened sheet through a die having a shape of a dental treatment trayThe M pieces are thermoformed into a dental treatment tray. The resulting dental treatment tray is capable of maintaining the shape of its tray at room temperature and can be used as a barrier layer in an oral treatment tray. However, the tray lacks thermal stability and loses dimensional stability at about 100 ° F (about 38 ℃). As a result, it was confirmed that the hot forming was carried outThe dental treatment tray made of M is not suitable for manufacturing oral treatment devices that are subjected to higher temperatures (i.e., up to 50 ℃) during transportation and storage.

The dental trays in the following examples were made by injection molding a wax-based composition as described herein. The wax-based compositions of the examples were initially formed by introducing the materials into a twin screw extruder having a plurality of zones, heating and mixing the materials in the extruder, extruding the composition into strands, cooling the extruded strands in a water bath, and cutting the strands into pellets. The pellets are then fed into an injection molding machine and injection molded into dental trays. The injection molding machine is configured to heat the wax-based composition initially prior to introduction into the mold cavity and then cool the material to form a solidified tray. The injection molded dental tray had an average sidewall thickness of about 0.007-0.008 mils (about 0.18-0.2mm), a thickened occlusal surface of about 0.010-0.013 mils (25-33 mm).