ORAL TREATMENT DEVICE, ORAL TREATMENT KIT, METHOD OF MANUFACTURING THE AVAILABLE DEVICE AND USE OF A

专利摘要:
wax-based compositions, articles produced from them and methods of manufacture and use. devices for oral treatment formed from wax-based compositions that are thermally stable when formed in a three-dimensional form at a temperature of at least 45 ° c and plastically deformable at room temperature (25 ° c). wax-based compositions include a fraction of wax homogeneously mixed with a fraction of the polymer. the wax fraction includes at least one wax. the polymer fraction includes at least one polymer selected in such a way that, when the wax and polymer are mixed homogeneously together, they produce a wax-based composition that has the desired properties of thermal stability and plastic deformation. oral treatment devices are dimensionally stable at a temperature of at least 40 ° c without external support and can be plastically deformed in a user's mouth to become at least partially personalized in terms of the size and shape of the user's unique dentition and / or a device in a user’s mouth.
公开号:BR112016007912B1
申请号:R112016007912-4
申请日:2014-03-07
公开日:2021-03-23
发明作者:Steven B. Johnson；David Lawrence Margetts；Barry Lee Hobson；Jonathan D. Scoville；Neil T. Jessop；Peter M. Allred；Dan E. Fischer
申请人:Ultradent Products, Inc.；
IPC主号:

专利说明:

[0001] [001] The present invention is in the field of wax-based compositions, barrier layers and oral treatment devices and other articles produced from such compositions, and methods for the production and use of the foregoing. 2. Relevant Technology
[0002] [002] Dental strips and trays are commonly used to apply whitening compositions and medications to a user's teeth. "Trays" are precast barriers designed to fit over some or all of a user's teeth and can be customized or non-personalized. Trays can be pre-loaded with an oral treatment composition or filled with a treatment composition by by the user at the time of use. "Strips" are generally non-personalized sheet-shaped barriers that include a treatment composition on one side or embedded within the barrier layer and that can be placed over and folded around the teeth of a user in a tray-like configuration.
[0003] [003] A type of custom dental impression is made by thermoforming a sheet of moisture-resistant thermoplastic polymer material, such as a copolymer of ethylene - vinyl acetate (EVA), along a plaster model of the teeth of a and then cutting the molded intermediate shape to produce the shape similar to the desired tray. A blocking material can be applied to the plaster model to form reservoirs in the custom tray, which can accommodate the placement of the additional treatment composition close to the surfaces of a person's teeth. Reservoirs can provide additional comfort by reducing orthodontic forces, in particular, with more rigid trays. The drawbacks of custom trays formed in this way include the time and cost of forming an impression of a person's teeth, typically at the dentist's office, using the impression to form the plaster model, the thermoforming of the sheet, and cutting the shape molded to obtain the personalized tray. The main benefit is that these trays usually provide the best fit, comfort and effectiveness in applying a medication to a user's teeth, compared to oral strips and other types of dental trays.
[0004] [004] Another type of personalized tray is made using a person's own teeth as the template (for example, the so-called “boil-and-bite” tray). In a typical customization process, a blank tray sample Non-personalized material made from a thermally softening polymer material is initially heated (for example, in hot water or in the microwave oven) to temporarily soften the material in the polymer tray The soft tray is then placed over the user's teeth and are custom shaped to the user’s teeth using forces applied by one or more of the bites, suction or pressure applied externally using the fingers. Once the custom tray has cooled enough to maintain its shape, it can be removed from the user’s mouth and is then ready for use. A disadvantage of self-made trays is that they can be bulky and uncomfortable, especially when under pressure. form of mouth guards in sports, which typically have a wall thickness of at least 3 mm and usually even more. And while there have been patents for thin-walled self-molding trays, such trays can be difficult for a non-dental professional to use, have poor fit and have had little acceptance in the market.
[0005] [005] Non-personalized trays lack characteristics corresponding to a user's exclusive dentition, but they can be made to approximate the size and shape of a variety of dental arches formed and dimensioned differently. A major disadvantage of non-personalized trays is their poor fit. The thicker wall trays can be bulky, uncomfortable and often have large gaps between the side walls and the surfaces of the user's teeth. Thinner and more flexible trays can better adapt to the shape of a user's teeth, but they have their own drawbacks. These thinner, more comfortable trays can be fragile and difficult to install and are more easily dislodged during use compared to custom-made trays or stiffer non-custom trays. Thin-walled impression trays made of materials that are sufficiently rigid and / or resilient to better maintain their impression-like shape and facilitate installation on a user's teeth impression tray are less adaptable and have impression walls that are more prone to moving away from a user's teeth during use, especially the lingual wall. This can both be irritating to the user and allow saliva to enter the trough, which can cause the treatment composition to diffuse into a person's oral cavity.
[0006] [006] Conventional dental treatment strips typically comprise a flexible plastic barrier layer coated or impregnated with a treatment composition on the side of the strip facing the user's teeth. To install the strip, a portion of the strip is placed on the front surfaces of the user's teeth and the rest is folded around the occlusion edges of the teeth and against the lingual surfaces. A disadvantage of strips is that they are generally more difficult to install on a user's teeth in the proper location compared to trays, which already have a chute in which the teeth will be placed, which directs the correct installation. However, a properly placed strip can remain in place and provide a high level of comfort during treatment, perhaps even more comfort than a dental tray. An improperly placed strip, however, may not cover the entire tooth surface properly to be treated, may need adjustment and may allow the treatment composition to diffuse rapidly into the user's oral cavity. In addition, strips with less adhesive treatment compositions are prone to slipping the teeth during use even as a result of minimal movement of the user's mouth, chin or tongue. It is usually recommended that users do not eat, drink, smoke or sleep while using the treatment strip. In some cases, the strip may become so dislodged or broken that it must be removed and replaced with a new strip to complete the desired treatment.
[0007] [007] Finally, the main obstacle to successful treatment is the inability of a user to complete the prescribed treatment regimen. If the treatment device is uncomfortable to use, difficult to install and / or prone to prematurely dislodge the user's teeth, the user can simply give up and prematurely abort the prescribed regimen. Thus, even if dental treatments are possible using a particular appliance or treatment method, they are less likely to be properly completed if the appliance's weaknesses or treatment method causes a user to become discouraged before the desired results are achieved . BRIEF SUMMARY
[0008] [008] Wax-based compositions suitable for making sheets or articles which are thermally stable and plastically deformable are disclosed in the present invention. Exemplary wax-based compositions include a wax fraction composed of at least one wax and a polymer fraction homogeneously mixed with the wax fraction composed of at least one polymer. According to one embodiment, the wax-based composition is plastically deformable at room temperature (25 ° C) and thermally stable when formed on a flat sheet or three-dimensional article at a temperature of at least 40 ° C, or at least about 42.5 ° C, or at least about 45 ° C, or at least about 48 ° C, or at least about 50 ° C, or at least about 52.5 ° C, or at least about 55 ° C, or at least about 60 ° C or at least about 65 ° C, or at least about 70 ° C.
[0009] [009] A method of manufacturing a wax-based composition that is suitable for making sheets or articles that are thermally stable and plastically deformable is also disclosed, in which the method comprises: (1) combining at least one wax and at least at least one polymer to form a mixture; and (2) processing the mixture to form a wax-based composition (a) which is composed of a fraction of wax homogeneously mixed with a fraction of polymer, (b) which is thermally stable when transformed into a flat sheet or article three-dimensional at a temperature of at least 45 ° C, and (c) which is plastically deformable at room temperature (25 ° C).
[0010] [010] Flat sheets and three-dimensional articles made from wax-based compositions as disclosed in the present invention can be used for any desired use, an example of which is as a barrier layer forming part of the oral treatment device. . According to one embodiment, the barrier layer may be in the form of a dental impression tray that has at least one side wall and at least one bottom wall that extends laterally from at least one side wall. According to another embodiment, the barrier layer may be in the form of a strip. Oral treatment devices include an oral treatment composition, which includes one or more active agents to provide a desired oral treatment.
[0011] [011] According to one modality, the barrier layers manufactured from wax-based compositions are non-personalized and devoid of characteristics corresponding to the user's exclusive dentition. Because of the unique properties of the wax-based compositions disclosed in the present invention, the barrier can be at least partially personalized when placed inside the user's mouth and heated to body temperature so that at least partially conform to the exclusive dentition of the user. particularly the occlusion surfaces. In this way, the oral treatment device can be self-personalized by a user during use. This eliminates the need to first perform a personalization procedure before placing an oral treatment composition adjacent to the barrier layer, in order to obtain a device that conforms closely to a user's exclusive dentition, in order to function as a at least partially personalized oral treatment device. And since the wax-based composition that forms the barrier layer is not elastic, but is susceptible to plastic deformation, since the tray is placed on a user's teeth there is less chance that the barrier layer move away from the user's teeth, as is often the case with flexible barrier layers made of an elastic and / or elastomeric material.
[0012] [012] Other examples of articles produced from wax-based compositions, as described in the present invention include, but are not limited to, therapeutic application devices (e.g., trays or strips) used to apply daytime therapeutic agents or at night for geriatric patients, convalescent patients, patients with poor hygiene, intubated humans or other patients to treat a variety of conditions, including dry mouth, infections, dental conditions, tooth sensitivity and the like. Examples of oral active agents include, but are not limited to, fluoride, desensitizing agents, anesthetics, remineralizing agents, antiplaque agents, antitartar agents, antimicrobial agents, antibiotics, chlorhexidine, doxycycline, or healing agents for oral soft tissues). Oral active agents can be contained within compositions of varying rheology, including, but not limited to, viscous adhesive compositions, substantially solid compositions, bitumen-like compositions, fluid or less viscous compositions. For example, a fluoride-based treatment composition can be a thick viscous gel or, alternatively, it can be a more fluid, less viscous composition, which can be easily rinsed off a patient's teeth. Alternatively, a solid active agent (eg, doxycycline or another antibiotic for the treatment of periodontal pockets) can be incorporated into a wall of a tray or wax-based strip and held against, or close to, a region of oral tissue for the prolonged treatment.
[0013] [013] Therapeutic devices may include a barrier coating made from a wax-based composition and a pre-loaded oral treatment composition thereon (for example, a sticky, viscous composition, substantially solid composition, or material similar to the fixing mass). Alternatively, therapeutic devices may include a barrier coating made from a wax-based composition and an absorbent insert or coating (for example, absorbent paper or sponge material) that acts as a reservoir to retain the most common oral compositions. fluid and less viscous inside the tray and adjacent to teeth and / or oral tissues that could undesirably diffuse or be expressed from the device into the oral cavity.
[0014] [014] Other treatment devices include, but are not limited to, orthodontic protection devices (for example, a tray or strip) to protect oral soft tissues from orthodontic devices that can cause irritation, particularly when installed for the first time, including orthodontic protective trays and strips that can form a barrier between the irritating features of an orthodontic device and soft oral tissues; devices for the treatment of temporomandibular joint disorders ("TMJ") ("TMJ disorders" or "TMD"); anti-smoking devices; customizable sports mouth guards, including customizable inserts for sports mouth guards and mouth guards for two-color molded sports, deformable strips or sheets for recording occlusal points, and surgical trays designed to protect oral tissues after oral surgeries and / or apply therapeutic agents.
[0015] [015] These and other advantages and features of the present invention will become more apparent from the following description and the appended claims, or can be understood by the practice of the invention as defined below. BRIEF DESCRIPTION OF THE DRAWINGS
[0016] [016] In order to better clarify the previous characteristics and advantages and other characteristics and advantages of the present invention, a more particular description of the invention will be processed by references to specific modalities of the same, which are illustrated in the attached drawings. It is appreciated that these drawings describe only typical modalities of the invention and, therefore, should not be considered as limiting its scope. The invention will be described and explained with additional specificity and detail through the use of the attached drawings, in which:
[0017] [017] Figures 1A-1B illustrate exemplary oral treatment trays made from wax-based compositions as disclosed in the present invention;
[0018] [018] Figures 1C-1D illustrate exemplary oral treatment devices that include a dental treatment tray and a solid oral treatment gel or composition within the tray;
[0019] [019] Figures 2A-2B illustrate exemplary oral treatment devices that include a dental treatment tray that has features that help the treatment device conform to the shape of a user's dental arch and an oral treatment gel or composition solid inside the tray;
[0020] [020] Figures 3A-3B illustrate exemplifying oral treatment devices that include a dental treatment tray with cuts or discontinuities that assist the treatment device to conform to a user's dental arch shape and a gel or composition of solid oral treatment inside the tray;
[0021] [021] Figures 4A-4B illustrate oral treatment devices contained in sealed protection packages with a detachable cover;
[0022] [022] Figures 5A-5B illustrate an oral treatment device that includes a barrier layer in the form of an initially flat strip coated with an oral treatment composition;
[0023] [023] Figures 6A-6B illustrate an oral treatment strip wrapped around and close to conformity to the shape of a user's teeth, as a result of the highly adaptable nature of the wax-based barrier layer and the adhesive nature of the composition of oral treatment;
[0024] [024] Figures 7A-7E illustrate various forms of strip-like barrier layers that can be used in molding oral treatment devices according to the invention;
[0025] [025] Figure 8A is a perspective view illustrating an exemplary oral treatment device having a barrier layer with a thick occlusal wall and thinner labial and lingual walls;
[0026] [026] Figure 8B is a cross-sectional view of the treatment device of Figure 8A taken along line 8B-8B which schematically illustrates the thick occlusal wall compared to the thinner labial and lingual walls;
[0027] [027] Figure 8C is a perspective view illustrating an exemplary pre-filled oral treatment device having a barrier layer with a thick occlusal wall, thinner labial and lingual walls and an oral treatment composition positioned on a lingual side the barrier layer;
[0028] [028] Figure 8D is a cross-sectional view of the pre-filled oral treatment device of Figure 8C taken along the 8D-8D line which schematically illustrates the thick occlusal wall compared to the thinner labial and lingual walls and the treatment composition;
[0029] [029] Figure 9B is a cross-sectional view of the pre-filled oral treatment device of Figure 9A taken along line 9B-9B which schematically illustrates the thick occlusal wall compared to the thinner labial and lingual walls and the substantially solid treatment composition;
[0030] [030] Figure 10A is a perspective view illustrating an exemplary oral treatment device, having a thick occlusal wall compared to the lingual and labial walls and a non-personalized V-shaped protrusion on the occlusal wall configured to fit the depressions in adjacent posterior teeth and improve the fit between the oral treatment device and a person's dental arch when used;
[0031] [031] Figure 10B is a cross-sectional view of the oral treatment device of Figure 10A taken along line 10B-10B which schematically illustrates the thick occlusal wall compared to the thinner labial and lingual walls and the shaped protrusion of V;
[0032] [032] Figure 11A illustrates an exemplary oral treatment device in use in maintaining an oral treatment composition against a posterior tooth, the treatment device having a thick occlusal wall and a V-shaped protrusion to improve fit within a recess of the posterior tooth;
[0033] [033] Figure 11B illustrates an exemplary oral treatment device in use in maintaining an oral treatment composition against an anterior tooth, the treatment device having a thick occlusal wall;
[0034] [034] Figure 12 is a cross-sectional view of an exemplary oral treatment device, having a lip wall with a curvature that corresponds to a facial surface of the tooth; and
[0035] [035] Figure 13 is a cross-sectional view of an exemplary oral treatment device, with labial and lingual walls that cover only part of a patient's teeth. DETAILED DESCRIPTION OF THE PREFERENTIAL MODALITIES
[0036] [036] I. INTRODUCTION
[0037] [037] Wax-based compositions formed from a wax component and a polymer component in order to be both thermally stable and plastically deformable are disclosed here. Since the wax-based compositions are thermally stable, the articles produced from them are able to maintain their shape without significant deformation (that is, they are dimensionally stable) in the absence of external forces when heated to temperatures at which these articles can be exposed. Since the wax-based compositions are plastically deformable, the articles produced from them can be plastically deformed by the application of a deformation force.
[0038] [038] Methods of making wax-based compositions of one or more types of wax, one or more types of polymers and optionally one or more auxiliary components are also disclosed in order to have the desired material and / or mechanical properties. The one or more types of wax and one or more types of polymers can be mixed homogeneously together to form wax-based compositions that contain a fraction of wax and a fraction of polymer. Heat and / or pressure can be applied to obtain a wax-based composition with the desired material and / or mechanical properties.
[0039] [039] Exemplary articles that can be produced from wax-based compositions, as disclosed in the present invention include leaves and three-dimensional shapes. The three-dimensional sheets and articles can be thermally stable and plastically deformable. The leaves can be used for any desired purpose, examples of which include, as a barrier layer on an oral treatment strip used to apply an oral treatment composition to the user's teeth and / or gums, such as an intermediate substrate, which is thermoformed in a dental treatment tray, and as a coating for reversibly sealing a hole in a container. Examples of useful three-dimensional articles include dental treatment trays, such as those produced by injection molding the wax-based composition or thermoforming a wax-based sheet.
[0040] [040] Oral treatment devices are an example of a specific application of examples of articles produced from wax-based compositions, as disclosed in the present invention. Oral treatment devices may include a barrier layer, such as a strip or tray, and one or more oral treatment compositions adjacent and / or impregnated within the barrier layer. An example oral treatment strip includes a wax-based sheet that is initially flat and includes an adjacent and / or impregnated oral treatment composition within the sheet. The oral treatment strip can be placed on and wrapped around at least a portion of a user's teeth. Another example of an oral treatment device includes a preformed dental treatment tray formed from a wax-based composition and an oral treatment composition placed and / or impregnated within the dental treatment tray. The pre-molded dental treatment tray makes it easier to place the oral treatment device on a person's teeth compared to an oral treatment strip.
[0041] [041] According to one modality, an oral treatment device includes a barrier layer that is initially non-personalized and devoid of characteristics corresponding to a user's exclusive dentition, but which can adapt to that person's teeth during use. According to one embodiment, the barrier layer is at least partially personalized when heated to body temperature and molding forces are applied, such as suction, bite and / or finger pressure. In this way, a self-personalized oral treatment device is provided which can be self-personalized in a user's mouth after placing an oral treatment composition on or in the barrier layer. This makes oral treatment much easier, as it provides a personalized comfortable fit device that can be done during oral treatment. This eliminates the heavy personalization procedures and delays normally involved in the production of personalized trays, whether using a plaster cast of a person's teeth or a “boil and bite” procedure. oral treatment or on or in a personalized dental tray The capacity of oral treatment devices that already include a treatment composition when self-personalized in the user's mouth is surprising and unexpected, which further emphasizes the original and inventive nature of the base compositions wax, as disclosed in the present invention.
[0042] [042] Kits that use barrier layers manufactured from wax-based compositions as disclosed in the present invention and oral treatment devices that include barrier layers and one or more adjacent or impregnated oral treatment compositions within the barrier layer are also provided. The kits can include multiple oral treatment devices, which include a barrier layer and one or more pre-applied oral treatment compositions. Alternatively, the kits can include one or more oral treatment devices, which include a barrier layer and one or more oral treatment compositions that can be applied to the barrier layer by a user.
[0043] [043] Methods for providing treatment to the user's teeth and / or gums use barrier layers made from wax-based compositions as described in the present invention and one or more oral treatment compositions that are pre-applied to the barrier layer or that can be applied to the barrier layer by a user at the time of use. According to one embodiment, a user places an oral treatment device that includes 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 compliance with the user's unique dentition in order to provide a better fit and comfort. The oral treatment device can be self-personalized by the user, as described in the present invention, such as by heating the wax-based barrier layer to body temperature inside the user's mouth and applying forces to plastically deform the barrier layer. in order to at least partially personalize the barrier layer, to include indentations that conform to the user's exclusive dentition. II. WAX BASED COMPOSITIONS
[0044] [044] Wax-based compositions as disclosed in the present invention include a wax fraction, a polymer fraction homogeneously mixed with the wax fraction and, optionally, one or more auxiliary components. Examples of waxes that can 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 and natural polymers. Examples of auxiliary components include plasticizers, flow modifiers and fillers.
[0045] [045] Examples of petroleum waxes include paraffin waxes (made from long chain alkane hydrocarbons) (eg IGI 1260A), intermediate waxes (mixture of branched and long chain alkanes), microcrystalline waxes (branched alkane hydrocarbons) higher molecular weight and more amorphous than paraffin waxes) (eg IGI 5909A), distilled waxes (eg Astorstat® distilled waxes, such as Astorstat 6988, Astorstat 6920, 10069, Astorstat 95, Astorstat 90, Astorstatat 75 and Astorstat 10316) and petroleum jelly. Examples of synthetic waxes include polyethylene waxes (based on polyethylene), Fischer-Tropsch waxes (produced from synthesis gas), chemically modified waxes (which are usually esterified or saponified), substituted amide waxes and polymerized α-olefins . Examples of mineral waxes include ceresin waxes, montana wax (extracted from lignin and brown coal), ozokerite (found in lignin beds) and peat waxes. Examples of vegetable waxes include bayberry wax (from the surface wax of the fruits of the laurel bush, Myrica faya), candelilla wax (from the Mexican shrubs Euphorbia cerifera and Euphorbia antisyphilitica), carnauba wax (from the leaves of the carnauba palm, Copernica cerifera ), castor wax (catalytically hydrogenated castor oil), esparto wax (a by-product of esparto papermaking, Macrochloa tenacissima), Japan wax (a vegetable triglyceride, from Rhus berries and Toxicodendron species), jojoba oil (extracted from the seeds of the jojoba bush, Simmondsia chinensis), ouricury wax (from Brazilian feather palm, Syagrus coronata), rice bran wax (obtained from rice bran, Oryza sativa), and soy wax (from oil soybean). Examples of animal waxes include beeswax (produced by bees), Chinese wax (produced by the insect deposit Ceroplastes ceriferus), lanolin (wool wax, from the sheep's sebaceous glands) and shellac wax (from the female's resin) of the insect Kerria lacca).
[0046] [046] Wax mixtures can be useful for incorporating the properties of materials from different waxes. For example, paraffin wax, intermediate wax and / or microcrystalline wax can be combined to provide a desired level of plastic deformation, at room temperature and dimensional stability at higher temperatures. Paraffin waxes, microcrystalline intermediates are all mixtures of fully saturated hydrocarbons with the general formula CnH2n + 2. Paraffin waxes predominantly include straight chain alkanes, microcrystalline waxes predominantly include branched alkanes of higher molecular weight than alkanes in paraffin waxes and intermediate waxes have components and properties intermediate to paraffin and microcrystalline waxes. The branching effect is to reduce the melting point and increase the viscosity. In general, paraffin waxes mainly comprise linear C18 to C40 alkanes, intermediate waxes have increased branching and comprise mainly C25 to C60 alkanes, microcrystalline waxes contain few linear alkanes or no linear alkanes, but have rather branched C25 to C85 alkanes complex.
[0047] [047] As a general rule, the properties of paraffin wax and microcrystalline waxes can be generalized as follows:
[0048] [048] The one or more waxes, comprising the wax fraction of wax-based compositions as disclosed in the present invention are typically included in an amount in the range of about 40% to about 95% by weight, preferably in a range of about 50% to about 93% by weight, more preferably, in a range of about 60% to about 90% by weight, and more preferably, in a range of about 70% to about 85% by weight of the wax-based composition.
[0049] [049] The polymer fraction can include at least one type of polymer, examples of which include one or more polymers selected from 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) (eg TEFLON), thermoplastic polyolefins (for example, 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), polycarbonates, methacrylates, acrylates, polyamides (for example, nylon), polyurethanes, polyvinyl chloride (PVC), synthetic rubber, phenol-formaldehyde resins (Bakelite), neoprene, polystyrene, polyacrylonitrile, PVB, silicone elastomers, and thermoplastic elastomers (for example , olefin-based elastomers, such as ethylene, propylene or butylene-based elastomers (for example, EngageTM thermoplastic elastomers, VistamaxxTM thermoplastic elastomers, such as VistamaxxTM 6102, VistamaxxTM 6202, and VistamaxxTM 3020, Duragrip® DGRm5050CL, and Theragrip® DGR 6250CL, and ® M TM6LFT). Natural polymeric materials include shellac, natural rubber, polysaccharides, cellulosic ethers, cellulose acetate, and proteins.
[0050] [050] According to one embodiment, the polymer fraction may have highly stable peroxide (ie, so as not to cause the peroxide bleaching agent to decompose) and / or good thermal stability (that is, so as to produce a strip or tray that maintains its shape when exposed to high temperatures during transport and storage).
[0051] [051] The one or more polymers comprising the polymer fraction of wax-based compositions as disclosed in the present invention are typically included in an amount in the range of about 5% to about 60% by weight, preferably in a range of about 7% to about 50% by weight, more preferably, in a range of about 10% to about 40% by weight, and more preferably, in a range of about 15% to about 30% by weight of the wax-based composition.
[0052] [052] When included, the one or more auxiliary components (for example, plasticizers, flow modifiers, and / or fillers) can be included in an amount in the range of about 0.01% to about 5% by weight of the wax-based composition, preferably in a range of about 0.1% to about 4% by weight, and more preferably, in a range of about 1% to about 3% by weight of the composition based on wax.
[0053] [053] At least a portion of the wax fraction, polymer fraction and / or auxiliary component may be similar and / or provided by the materials contained in Parafilm®, which is sold in sheet form and which contains a mixture of wax and polyolefin. Parafilm® M is a flexible sheet material with a paper backing to prevent self-adhesion and is normally used to temporarily seal vials or cuvettes in chemical laboratories. Parafilm® F is commonly used in plant grafts. Parafilm® sheets typically soften at about 100 ° F (or about 38 ° C) and if a Parafilm® sheet is thermoformed in a dental treatment tray, it begins to sag at temperatures around 38 ° C and above. As a result, oral treatment strips made using native Parafilm® as a barrier layer can become wrinkled or corrugated at elevated temperatures during transport and storage (that is, they can reach 50 ° C or more). In addition, oral treatment strips made using native Parafilm® as the barrier layer can become excessively soft and gummy when placed in the mouth and exposed to body temperature over long periods of time, allowing users to easily bite and puncture the barrier layer of Parafilm®, compromising its ability to function as a barrier to saliva.
[0054] [054] Unexpectedly, however, when the Parafilm® sheet material is cut into pieces and used as a feed material in an injection molding process, the resulting injection molded trays are thermally stable at a temperature above 40 ° C (for example, at about 50-52 ° C, depending on injection molding conditions). Therefore, the "native" Parafilm® composition is apparently transformed into a new composition of matter when subjected to the temperatures and / or pressures associated with injection molding processes, such as those described in the present invention. In addition, Parafilm® can be used as a mixing component in conjunction with other components described in the present invention, to obtain trays or strips having thermal stability at temperatures of at least 40 ° C.
[0055] [055] According to various modalities, wax-based compositions are thermally stable (that is, they are dimensionally stable and resist significant deformation) when formed on a flat sheet or a three-dimensional article and heated to a temperature at which the sheet or article is typically submitted during transport and storage. According to one embodiment, the wax-based composition is thermally stable when heated to a temperature of at least 40 ° C, or at least about 42.5 ° C, or at least about 45 ° C, or at least about 48 ° C, or at least about 50 ° C, or at least about 52.5 ° C, or at least about 55 ° C, or at least about 60 ° C, or at least about 65 ° C, or at least about 70 ° C.
[0056] [056] In addition, the wax-based composition can be plastically deformable. That is, the composition can be formed into a desired shape and then maintain that shape without the application of an external force. According to one embodiment, the wax-based composition is plastically deformable and non-brittle at room temperature (25 ° C). In other words, the wax-based composition can be configured in the desired shape, without breaking or cracking, and in order to maintain that shape without heating 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 at an elevated temperature into a desired three-dimensional article of a specified thickness. In some embodiments, the wax-based composition is semi-rigid at room temperature and becomes more flexible and deformable when heated above room temperature, such as at body temperature, in the case of an oral treatment device that includes a barrier layer based on wax.
[0057] [057] Depending on the relative concentrations of the wax and polymer fractions, the wax fraction can comprise a continuous phase and the polymer fraction can comprise a dispersed phase within the continuous wax phase. Alternatively, the polymer fraction may comprise a continuous phase and the wax fraction may comprise a phase dispersed within the continuous wax phase. In some cases, it is possible for the wax and polymer fractions to form an interpenetrating network without continuous and dispersed phases.
[0058] [058] An exemplary method of making a wax-based composition that is suitable for preparing sheets or articles that are thermally stable and plastically deformable includes: (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 that is composed of a fraction of wax homogeneously mixed with a fraction of the polymer.
[0059] [059] According to one embodiment, at least one type of wax and at least one type of polymer are combined and processed using an extruder (for example, a single screw or double screw extruder). The extruder can form the wax-based composition in the form of a sheet having a desired thickness. The sheet can be used as-is or as-formed, such as by thermoforming, in a desired shape of an article of manufacture (for example, a dental treatment tray). Alternatively, the extruder can form the wax-based composition into a filament that is cut into individual pellets, which can then be transformed, such as by injection molding, to form a desired shape of an article of manufacture. Other mixing apparatus known in the art can be used to form wax-polymer mixtures, which are then extruded, injection molded, or otherwise, formed in a desired shape.
[0060] [060] Exemplary extruders can include a plurality of zones (for example, 10 zones), such as mixing, heating and pressurizing zones. The wax, polymers and auxiliary materials can be fed separately to the extruder in different zones or together in the same zone. For example, the one or more polymer components can be fed to Zone 1, and the one or more wax components can be fed to Zone 3. Auxiliary components, if used, can be fed to one of these zones or to a zone different. The zones can have similar or different temperatures. In general, the materials fed and mixed in the extruder can be subjected to one or more temperatures in the range of about 50 ° C to about 225 ° C, preferably in a range of about 55 ° C to about 210 ° Ç. More preferably, materials in the anterior zones are subjected to a higher temperature in the range of about 135 ° C to about 220 ° C and, in the posterior zones, to a lower temperature in the range of about 50 ° C at about 125 ° C in another part of the extruder, more preferably at a higher temperature in the anterior zones, in a range of about 140 ° C to about 210 ° C and at a lower temperature in the posterior zones in a range of about 55 ° C to about 120 ° C. The pressure inside the extruder can be about 1000 psi, preferably about 100 psi, more preferably about 50 psi, and most preferably, in the range of about 1 to about 25 psi .
[0061] [061] Exemplary injection molding devices include a funnel, a threaded barrel, an injection nozzle, a valve port, a mold cavity and a mold core. In an injection molding process, the wax-based composition can be subjected to one or more initial melting point or softening temperatures of the composition in a range of about 40 ° C to about 200 ° C, preferably , in a range of about 45 ° C to about 150 ° C, and more preferably, in a range of about 50 ° C to about 120 ° C. The feed barrel can have multiple heating zones for increasing the temperature. In general, the highest temperature is reached at the valve port. The softened or molten composition is introduced into the mold cavity under pressure in order to fill the mold cavity, such as at a pressure in the range of about 1000 psi to about 50,000 psi, preferably in a range of about 2500 psi to about 40,000 psi, more preferably in the range of about 5000 psi to about 30,000 psi, even more preferably in the range of about 7500 psi to about 20,000 psi, and most preferably in a range range from about 10,000 psi to about 15,000 psi. To obtain a solidified injection molded article, the mold core and cavity can have a reduced temperature in the range of about -10 ° C to about 40 ° C, preferably in a range of about -5 ° C to about 30 ° C, more preferably, in a range of about 0 ° C to about 25 ° C, even more preferably, in a range of about 2 ° C to about 20 ° C, and more preferably, in a range of about 3 ° C to about 10 ° C. III. ARTICLES PRODUCED FROM WAX-BASED COMPOSITIONS
[0062] [062] Examples of articles that can be produced from wax-based compositions as disclosed in the present invention include, but are not limited to, sheets, oral treatment strips, orifice sealing sheets, three-dimensional shaped articles and dental treatment trays. The sheet-like articles can be flat and are flexible and plastically deformable so that they are able to be placed on an object and then wrapped around the object to a desired configuration that is able to maintain its shape. In some cases, the sheets can be “customizable” to include three-dimensional characteristics of the object around which it is wrapped. Likewise, molded three-dimensional articles can be plastically deformable so that they are capable of being placed on an object and then, still adapted for better fit on the object and better conformation with the three-dimensional characteristics of the object around which it is adapted.
[0063] [063] According to various modalities, flat or curved sheets are provided which are plastically deformable at room temperature (25 ° C) and thermally stable at temperatures of at least 40 ° C, or at least about 42.5 ° C , or at least about 45 ° C, or at least about 48 ° C, or at least about 50 ° C, or at least about 52.5 ° C, or at least about 55 ° C, or at least at least about 60 ° C, or at least about 65 ° C, or at least about 70 ° (for example, at temperatures between 50-75 ° C, depending on the formulation). This allows the sheet-like articles produced from the wax-based compositions disclosed in the present invention to be manufactured, stored and transported at temperatures of 50-75 ° C or more, without losing their desired shape. The sheets comprise a wax-based composition that includes a fraction of wax and a fraction of polymer homogeneously mixed with the fraction of wax. The wax fraction includes at least one wax. The polymer fraction includes at least one polymer. The sheet can be formed by extruding the wax-based composition.
[0064] [064] According to other modalities, three-dimensional articles are provided which are plastically deformable at room temperature (25 ° C) and thermally stable at temperatures of at least 40 ° C, or at least about 42.5 ° C, or at least about 45 ° C, or at least about 48 ° C, or at least about 50 ° C, or at least about 52.5 ° C, or at least about 55 ° C, or at least about 60 ° C, or at least about 65 ° C, or at least about 70 ° (for example, at temperatures between 50-75 ° C, depending on the formulation) and are therefore dimensionally stable at elevated temperatures. IV. ORAL TREATMENT KITS AND DEVICES A. General Discussion
[0065] [065] Oral treatment devices which include a barrier layer composed of a wax-based composition and an oral treatment composition disposed adjacent and / or impregnated within the barrier layer are described in the present invention. The barrier layer can be in the form of a tray or strip. A dental impression tray typically includes at least one side wall (for example, at least one lip wall and, optionally, also a lingual wall) and a bottom wall adjacent to, and extending laterally from at least a side wall (for example, extending lingually from the labial wall or forming a transition or bridge between the labial and lingual walls). The strip-like barriers and / or at least one side wall and the bottom wall of a dental treatment tray comprise a wax-based composition that includes at least one wax and at least one polymer homogeneously mixed with the wax. Oral treatment devices can be formed by thermoforming a wax-based sheet, injection molding a wax-based composition, or any other suitable method known in the art.
[0066] [066] According to various modalities, oral treatment devices produced from wax-based compositions disclosed in the present invention are plastically deformable at room temperature (25 ° C) and thermally stable at temperatures of at least 40 ° C, or at least about 42.5 ° C, or at least about 45 ° C, or at least about 47.5 ° C, or at least about 50 ° C, or at least about 53 ° C, or at least about 55 ° C, or at least about 60 ° C, or at least about 65 ° C, or at least about 70 ° C (for example, at temperatures between 50-75 ° C, depending on the formulation ) and are therefore dimensionally stable at elevated temperatures. This allows oral treatment devices produced from wax-based compositions disclosed in the present invention to be manufactured, stored and transported at temperatures of 50-75 ° C or more, without losing their desired shape. However, when placed in a user's mouth, dental treatment trays and strip-like barrier layers produced from the wax-based compositions described here can easily conform to the size and shape of a user's exclusive dentition ( for example, they are self-personalized in a user's mouth). They can easily adapt to occlusal surfaces while still resisting puncture because they are not unduly softened at body temperatures.
[0067] [067] According to one modality, the tray or strip may be non-personalized and devoid of characteristics corresponding to the user's exclusive dentition. Once placed in a user's mouth, the tray or strip can heat up to body temperature, which facilitates the ability of the tray or strip to at least partially conform to the user's exclusive dentition and thus become at least partially personalized. . For example, the tray or strip can be at least partially personalized in the user's mouth using molding forces such as suction, bite or finger pressure. According to another modality, the tray can be customized (for example, using a plaster model of a user's teeth to record indentations in the tray corresponding to the user's exclusive dentition). Oral strips and trays are advantageously formulated so that it is difficult or impossible for a user to bite through the occlusal surface of the tray or strip in order to maintain a barrier to saliva.
[0068] [068] Kits for providing oral treatments may include various oral treatment devices that include a wax-based barrier layer and one or more pre-applied oral treatment compositions. Alternatively, the kits may include one or more wax-based barrier layers and one or more oral treatment compositions that can be applied to the barrier layers by the user at the time of use. Kits can include some barrier layers configured to fit over a person's upper teeth and other barrier layers configured to fit over a person's lower teeth.
[0069] [069] Alternatively, a plurality of single-use disposable personalized dental treatment trays produced from wax-based compositions, as disclosed in the present invention can be provided to a user in a kit. According to one modality, the personalized dental impression tray kit allows the user to take advantage of a new personalized dental impression tray for each treatment event. In addition, due to the plastically deformable nature of the wax-based composition, the trays produced can therefore be more comfortable and more suitable than professional fitted custom trays.
[0070] [070] A method of making a single-use disposable personalized dental impression tray kit includes: (1) taking an impression of a user's teeth using impression material; (2) making a plaster model of the user's teeth from the impression of the user's teeth; (3) providing a plurality of sheets composed of a wax-based composition as disclosed in the present invention; (4) thermoforming the sheets using the plaster model to form the plurality of personalized dental treatment trays; and (5) optionally, cut excess material from the tray to maximize proper size and fit. Custom disposable single-use disposable wax-based dental impression trays can be used in a kit that includes an oral treatment composition that is loaded into the impression trays by the user or can be preloaded with an oral treatment composition.
[0071] [071] Regardless of its shape, the barrier layer is typically moisture resistant in order to protect the oral treatment composition from the saliva in a user's mouth. Because waxes and polymers tend to be hydrophobic, wax-based compositions, as disclosed in the present invention, will typically be resistant to moisture. Wax-based barrier layers will typically have a thickness in the range of about 0.025 mm to about 1.5 mm, or from about 0.05 mm to about 1.25 mm, or from about 0.075 mm to about 1 mm, or from about 0.09 mm to about 0.75 mm, or from about 0.1 mm to about 0.5 mm, or from about 0.15 mm to about 0.35 mm.
[0072] [072] According to one embodiment, the occlusal walls of exemplary dental impression trays may have a greater cross-sectional thickness than one or more side walls (for example, between about 20-100% thicker, or about 30-75% thicker, or about 40-60% thicker). This provides several benefits, including the ability of dental impression trays to be self-customized for a user's teeth without the user biting and drilling into the occlusal wall. It can also increase the dimensional stability of dental treatment trays by providing a more rigid base to which one or more side walls are attached without compromising comfort and fit. The occlusal wall is typically the last wall to come into contact with a user's teeth during installation, so that greater rigidity of the occlusal wall does not significantly decrease the capacity of the lateral wall (s) more thin (s) that are customized or adapted to the user's tooth and / or lip surfaces. In addition, because the occlusal wall can be easily self-customized to the occlusal surfaces of the user's tooth by biting, the user can easily self-personalize the occlusal wall regardless of the thickness increase. And in fact, increasing the thickness is more beneficial in the occlusal region that is subjected to greater personalization forces (ie, bite).
[0073] [073] Another benefit of providing a thick occlusal wall is that it facilitates the injection molding of dental trays of relatively thin wall from the wax-based compositions disclosed in the present invention. Since the occlusal wall of a molded tray is typically approximately in the middle between the labial and lingual walls, the cavity of the mold in the region corresponding to a thick occlusal wall will be wider than the adjacent regions corresponding to the thinner labial and lingual walls. . A wider mold cavity in the middle region of the mold facilitates injection molding through a better flow of the softened wax-based composition throughout the mold cavity.
[0074] [074] Compositions for oral treatment can include at least one active agent, at least one tissue adhesion agent (or thickener), a liquid solvent or gel, carrier or vehicle within which the active agent and the adhesion agent of tissues are dispersed, and other components and adjuvants as desired. The treatment composition can comprise microspheres or continuous or discontinuous layers positioned so as to contact at least a portion of a person's gums and / or tooth surfaces. The treatment compositions can have a consistency of a liquid, gel, thick viscous material, fixing mass or solid. Fixing solids and masses can become more sticky and adhesive to teeth and / or gums when moistened with water or saliva. In some cases, the main difference between a "gel" and a "fixing mass" or "solid" is the level of solvent or carrier in the composition. In general, the higher the concentration of the solvent or carrier in relation to the tissue adhesion, the less viscous the composition is.The lower the concentration of the solvent or carrier in relation to the tissue adhesion agent, the more viscous, similar to the fixing mass or solid is the composition.
[0075] [075] Examples of active agents for oral compositions include tooth whitening agents, desensitizing agents, remineralizing agents, antimicrobial agents, antiplaque agents, antitartar agents, gum softening agents, anesthetics, antioxidants and breath-fighting agents. Examples of tooth whitening agents include aqueous hydrogen peroxide, carbamide peroxide, metal perborates (eg sodium perborate), metal percarbonates (eg sodium percarbonate), metal peroxides (eg calcium), metal chlorites and hypochlorites, peroxyacids (eg, peroxyacetic acid), and peroxyacid salts.
[0076] [076] The bleaching agents in the tooth whitening compositions, according to the invention, can have any desired concentration, for example, between 1-90% by weight of the tooth whitening composition. The concentration of the tooth whitening agent can be adjusted depending on the desired treatment time for each whitening session. The bleaching agent is preferably included in an amount in the range of about 1% to about 60% by weight, more preferably in the range of about 3% to about 40% by weight, and more preferably, in a range of about 5% to about 30% by weight. When a tooth whitening agent is used, the materials used to make the wax-based composition can be selected so as not to react prematurely with the whitening agent and destabilize the whitening agent.
[0077] [077] Examples of desensitizing agents include potassium nitrate, other potassium salts, citric acid, citrates 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, cetylpyridinium chloride and benzalkonium chloride. An example of an anti-plaque or anti-tartar agent is pyrophosphate salts. Examples of gingival softening agents include aloe vera, neutral 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 bad breath agents include camphor, wintergreen oil, peppermint, mint and methyl salicylate.
[0078] [078] Tissue adhesives, tackifiers or thickening agents can include a wide variety of hydrophilic polymers. Examples include polyvinyl pyrrolidone (PVP), PVP copolymers - vinyl acetate, carboxypolymethylene (for example, from CARBOPOL, sold by Novean, Inc.), polyethylene oxide (for example, POLYOX, produced by Union Carbide), polymers or copolymers of polyacrylic acid (e.g., PEMULEN, sold by Novean, Inc.), polyacrylates, polyacrylamides, polyacrylic acid and polyacrylamide copolymers, carboxymethylcellulose, carboxypropylcellulose, cellulosic ethers, polysaccharide gums, proteins and the like. Examples of PVPs include Kollidon 30, a polyvinyl pyrrolidone polymer sold by BASF with a molecular weight of 50,000, Kollidon VA 60, a polyvinyl pyrrolidone polymer having a molecular weight of 60,000, and Kollidon 90 F, a polyvinyl pyrrolidone polymer having a molecular weight of 1.3 million.
[0079] [079] In the case where the oral treatment composition is a gel, the one or more tissue bonding agents are preferably included in an amount in the range of about 1% to about 50% by weight of the treatment gel, more preferably, in a range of about 3% to about 30% by weight, and more preferably, in a range of about 5% to about 20% by weight.
[0080] [080] In the case where the oral treatment composition is a fixing mass or solid, the one or more tissue bonding agents are preferably included in an amount in the range of about 10% to about 90 % by weight of the substantially solid treatment composition, more preferably, a range of about 20% to about 80% by weight, and more preferably, in a range of about 40% to about 75% by weight.
[0081] [081] Liquids and gels, including sticky viscous gels, may include one or more solvents, carriers or vehicles, liquids or gels, in which the active agent, tissue bonding agent and the other components are dissolved or dispersed. Examples of liquid or gel solvents, carriers or vehicles include water, alcohols (eg ethyl alcohol), and polyols (eg glycerin, sorbitol, mannitol, other sugar alcohols, propylene glycol, 1,3-propanediol, polyethylene glycol , polyethylene oxide and polypropylene glycol).
[0082] [082] For hard or solid fixing masses, the concentration of solvent, carrier or vehicle will normally be attenuated compared to treatment gels. When it is desired to convert a gel into a fixative or solid mass composition, it may be advantageous to include one or more volatile solvents that can be removed by evaporation (for example, water, alcohols, acetone and other organic solvents). Due to the affinity of hydrophilic polymers for water, even treatment compositions that appear to be solid can include a significant amount of bound water (for example, about 10% or more by weight of the treatment composition). In the event that the treatment composition has the consistency of a highly viscous or rigid fixing mass, the composition will generally include a solvent, carrier or vehicle that acts as a plasticizer or softening agent.
[0083] [083] Compositions for oral treatment can optionally include other components, as desired, to obtain treatment compositions that have desired properties. Examples include bleaching agent stabilizers (eg EDTA, EDTA salts, citric acid and its salts, phosphoric acid and its salts, phenol phosphonic acid and its salts, gluconic acid and its salts, alkali metal pyrophosphates, polyphosphates of alkali metals and alkyl sulfates), neutralizing agents (for example, sodium hydroxide and triethanolamine), inorganic thickening agents (for example, smoked silica), dyes, flavors, sweeteners and the like.
[0084] [084] According to one modality, oral treatment devices may have a longitudinal profile in the shape of a horseshoe and a trough with a U-shaped cross section, as in conventional bleaching trays. Alternatively, oral treatment devices may have barrier layers with other shapes, such as flat strips that are rectangular or contoured to bend around and fit over a user's teeth.
[0085] [085] Other examples of articles produced from wax-based compositions, as described herein, include, but are not limited to, therapeutic application devices (for example, trays or strips) used to apply daytime therapeutic agents or at night to geriatric patients, convalescent patients, patients with poor hygiene, intubated humans or other patients to treat a variety of conditions, including dry mouth, infections, dental disease, tooth sensitivity and the like. Examples of oral active agents include, but are not limited to, fluoride, desensitizing agents, anesthetics, remineralizing agents, antiplaque agents, antitartar agents, antimicrobial agents, antibiotics, chlorhexidine, doxycycline, or oral soft tissue healing agents). The oral active agents can be contained in compositions of varying rheology, including, but not limited to, adhesive compositions, substantially solid viscous compositions, compositions similar to fixing mass, such as less viscous or fluid compositions. For example, a fluoride treatment composition can be a thick, viscous gel or, alternatively, it can be a less viscous, more fluid composition that can be easily rinsed off a patient's teeth. Alternatively, a solid active agent (for example, doxycycline or another antibiotic for the treatment of periodontal pockets) can be incorporated into a wall of a tray or wax-based strip and held against, or close to, a region of oral tissue for the prolonged treatment.
[0086] [086] Therapeutic devices may include a barrier coating made from a wax-based composition and a pre-loaded oral treatment composition thereon (for example, a sticky viscous composition, substantially solid composition, or fixing mass and the like). Alternatively, therapeutic devices may include a barrier coating made from a wax-based composition and an absorbent insert or coating (for example, absorbent paper or sponge material) that acts as a reservoir to retain the most common oral compositions. fluid, less viscous inside the tray and adjacent to teeth and / or oral tissues that could diffuse or be expressed from the device to the oral cavity in an undesirable manner.
[0087] [087] Other treatment devices include, but are not limited to, orthodontic protection devices (for example, a tray or strip) to protect oral soft tissues from orthodontic devices that can cause irritation, particularly when installed for the first time, including orthodontic protection trays and strips that can form a barrier between the irritating features of an orthodontic device and soft oral tissues; devices for the treatment of temporomandibular joint disorders ("TMJ") ("TMJ disorders" or "TMD"); anti-smoking devices; customizable sports mouth guards, including customizable inserts for sports mouth guards and mouth guards for two-color molded sports, deformable strips or sheets to record occlusal points, and surgical trays designed to protect oral tissues after oral surgery and / or application of therapeutic agents. B. Exemplifying Illustrations
[0088] [088] Reference is now made to the drawings that illustrate various modalities of oral treatment devices, as disclosed in the present invention. Figures 1A and 1B illustrate an oral treatment tray or insert 100 formed from a wax-based material, as disclosed in the present invention. The tray or insert 100 generally includes a flexible three-dimensional body 102 having a generally horseshoe-shaped configuration defined by a lip wall 104, an occlusal wall 106 that extends laterally (e.g., lingually) from the lip wall 104 , and a lingual wall 108 that extends laterally (e.g., occlusally-gingivally) from the occlusal wall 106. The labial wall 104, the occlusal wall 106 and the lingual wall 108 together define a trough 110 that has a cross section generally U-shaped.
[0089] [089] Figure 1B is a cross-sectional view of the tray or insert 100 of Figure 1A taken along line 1B-1B. As illustrated in this view, the lip wall 104, occlusal wall 106, and the lingual wall 108 provide the body 102 with a substantially continuous wall thickness 112. It will be appreciated, however, that the tray or insert 100 can have varying thicknesses in different regions to provide the desired functionality.
[0090] [090] The oral treatment tray or insert 100 can be used to provide a variety of different functions and can have different and / or varying thicknesses depending on its intended use. When used as a treatment tray to apply a medication or other oral active agent, tray 100 can be thin-walled, flexible and easily adaptable to a person's teeth to provide a good fit and comfort. Since the wax-based composition of the tray 100 is plastically deformable, the tray body 102 is able to register and maintain the unique shape and size of a person's unique dentition. When used as an oral treatment tray to apply an oral agent, the lip wall 104, lingual wall 106 and occlusal wall 108 can have the same or different thicknesses in the range of about 0.001 ”to about 0.04", or about from 0.002 "to about 0.02", or about 0.004 "to about 0.01", or about 0.005 "to about 0.008.
[0091] [091] In the case where oral treatment device 100 is used for a different purpose than simply applying a medication or other oral hygiene composition, such as protecting soft oral tissues from irritation, body 102 has a thickness of the cross section that it is thicker, at least for some reasons, and potentially softer and more flexible. For example, when a patient has been fitted with orthodontic devices or has recently undergone oral surgery (for example, and has filaments or rods in the mouth), the tray must be thick enough, yet flexible, to record, improve and cushion sharp points or protrusions that they may otherwise irritate soft oral tissues when in contact with them. The soft wax-based tray 100 is capable of providing a smoother and more uniform surface that is smooth for soft oral tissues. The tray 100 can also have either a unique shape to accommodate a particular type of application or hardware within a person's mouth and / or can be highly adaptable to easily conform to the application or hardware.
[0092] [092] In the case where the oral treatment device 100 is used to treat TMJ disorders, the tray body 102 may have an occlusal wall 108 that is of sufficient thickness and cross-sectional strength to provide a desired therapeutic effect. For example, it may be desirable to keep the molars in approach. In such a case, the posterior portion of the occlusal wall 108 may have a thickness and firmness to provide the desired bridging and / or levering effect to relieve pain in the TMJ and promote healing. The exact thickness can vary on a case-by-case basis and can be prescribed by a dentist or oral surgeon. In general, the thickness of the TMJ trays as described in the present invention can be in the range of about 0.01 ”to about 0.2”, preferably in the range of about 0.025 ”to about 0.15 ", and more preferably, in a range of about 0.05” to about 0.1 ”.
[0093] [093] In the case where the oral treatment device 100 is used as an anti-smoking device, the tray body 102 may have an occlusal wall 108 that has sufficient thickness and cross-section strength to provide a desired therapeutic effect. For example, it may be desirable to keep molar teeth and other teeth grinding together at night during sleep. In such a case, the posterior portion of the occlusal wall 108 may have a thickness and firmness to provide the desired anti-smoking effect to protect the teeth. The exact thickness can vary on a case-by-case basis and can be prescribed by a dentist. In general, the thickness of the anti-gum trays, as described in the present invention, can be in the range of about 0.001 ”to about 0.1”, preferably in the range of about 0.005 ”to about 0, 08 ", and more preferably, in a range of about 0.01” to about 0.05 ”.
[0094] [094] The oral treatment device 100 can also be used as a mouthguard for sports or as a self-customizable insert for a molded polymer mouthpiece with a chute designed to accommodate a custom insert made of a material based on wax. In the case where the oral treatment device 100 provides the structure of the mouth guard for sports, the tray body 102 can have a thickness in a range of about 3 mm (about 1/8 ”) to about 6 mm (about 1/4 ") in order to protect teeth from blows or sharp impacts during sporting events. The 102 tray body can be formed by two-color molding, with a flexible, yet firm and durable outer mouth protective shell , which is capable of receiving and distributing the impact forces that can occur during sporting events and which can be made from any suitable polymer material, and an internal customizable layer made of a wax-based composition, as described in the present invention, which is capable of being personalized by the user to register the user's exclusive dentition and maximize comfort and fit. In such cases, the protective mouth peel can have a thickness in the range of about 0.1 ” at about 0.3 ", from price in a range of about 0.12 ”to about 0.275”, and more preferably, in a range of about 0.14 ”to about 0.2” and the customizable inner layer made of a custom composition wax base can have a thickness in a range of about 0.005 "to about 0.15”, preferably in a range of about 0.02 "to about 0.125", and more preferably, in a range from about 0.02 ”to about 0.1".
[0095] [095] When the tray body 102 is a customizable insert for a sports mouth guard, it can have a thickness in a range of about 0.005 ”to about 0.15", preferably in a range of about 0.02 "to about 0.125", and more preferably, in a range of about 0.02 "to about 0.1". In some cases, the tray 102 can be a disposable insert that is used for a single or multiple sporting events, then removed and replaced with a new tray body 102 for a future sporting event, so the tray body 102 can be easily customized and then replaced if it becomes deformed or stretched over time during one or more sporting events.
[0096] [096] Although the following drawings are discussed in terms of dental treatment trays for use in applying a dental treatment composition, it should be understood that anyone can be modified to work for any desired use, including the various devices and uses described above with reference to Figures 1A and 1B and other parts of the disclosure.
[0097] [097] Figure 1C is a perspective view of an oral treatment device 100 comprising a wax-based barrier layer 102 that has a front side wall 104, a rear side wall 106, and a shaped back wall horseshoe 108, which together define a rail 110 which has a generally U-shaped cross section throughout the horseshoe. Arranged within the chute 110 is an oral treatment composition 112 which can be a gel, such as a thick, viscous gel, which can assist in reliably fixing the dental treatment tray in the appropriate position on a user's teeth during use . The oral treatment composition 112 can have a consistency ranging from a gel, a thick, viscous gel, to a solid treatment composition. The oral treatment composition 112 can be a viscous gel having a diameter or thickness of the cross section in a range of about 1 mm to about 5 mm, more preferably, in a range of about 2 mm to about 4 mm . The gel can be a microsphere of continuous composition.
[0098] [098] Figure 1D represents an oral treatment device 100 'which includes a wax-based barrier layer 102 in the form of a dental tray that has a horseshoe shape with a substantially U-shaped cross section. The layer barrier 102 includes front side wall 104, rear side wall 106 and bottom wall 108 which together define a trough 110 having a general U-shaped cross section. Within trough 110 is an oral treatment composition 112 'which it substantially covers the inner walls instead of being a compositing microsphere. The oral treatment composition 112 'can be a gel, a thick, viscous gel, a fixing mass or a solid composition. Treatment composition 112 'is preferably a solid or hard fixing mass having a thickness in the range of about 0.2 mm to about 2 mm, more preferably, in a range of about 0.5 mm to about 1 mm.
[0099] [099] In an alternative embodiment, Figure 1D can be understood as illustrating an oral treatment device 100 'that includes a wax-based barrier layer 102 in the form of a dental tray that has a horseshoe shape with a section substantially U-shaped, as described above, and an absorbent coating 112 'positioned within the trough 110 to retain an oral treatment composition within the trough 110 and against the teeth (not shown) during use. The absorbent coating 112 'can comprise any known absorbent material, examples of which include absorbent paper, open cell foam and the like. The absorbent coating 112 'can be used, for example, when the oral treatment composition is sufficiently fluid or low viscosity to easily run out of the trough 110 or be easily squeezed out of the trough 110, as a result of pressure light applied to the wax-based barrier layer. In the case when the oral treatment device 100 'is used to deliver therapeutic agents to patients and remain in the mouth for long periods of time (for example, 4 hours or more), the absorbent coating 112' helps to maintain prolonged contact between the composition of oral treatment and the teeth and / or gums.
[0100] [0100] Figures 2A and 2B show oral treatment devices 200, 200 ', each of which includes a barrier layer 202 that has a front side wall 204, a rear side wall 206, and a bottom wall 208, which together define a trough 210 in which a microsphere of the treatment composition 212 (Figure 2A) or a continuous layer of the treatment composition 212 '(Figure 2B) is discarded. In addition, oral care devices 200, 200 'include a first notch 214 on the front side wall 204 and a second notch 216 on the back side wall 206. Notches 214 and 216 assist oral care devices 200, 200', conform to the variety of sizes and shapes of dental arches.
[0101] [0101] Figures 3A and 3B represent oral treatment devices 300, 300 'with characteristics that help the barrier layers conform better to the size and shape of the various dental arches. Instead of continuous side walls, oral treatment devices 300, 300 'include a barrier layer 302 that has a front side wall 304, a rear side wall 306, and a bottom wall 308 that interconnect the front side wall 304 and the posterior side wall 306. The posterior side wall 306 also includes a first section of the posterior side wall 306a which includes a first cut or discontinuity 307 and a second section of the posterior side wall 306b separated from the first section of the posterior side wall 306a by second cuts or discontinuities 309. The first posterior lateral wall section 306a is configured to wrap and be adjacent to the internal surfaces of a person's incisors and canines. The second posterior side wall section 306b is configured to wrap and contact the inner surfaces of a person's premolars and, optionally, one or more molars.
[0102] [0102] The cuts or discontinuities 309 between the first and second side sections 306a, 306b facilitate a good fit against a person's incisors and canines, especially at the junction of the canines and premolars. The cuts or discontinuities 309 compensate for the sharp difference in width between a person's premolars adjacent to the second posterior lateral wall section 306b and the canines adjacent to the first posterior lateral wall section 306a. The discontinuity or cut 307 in the first side wall section 306a also assists in shaping the first side wall section 306a with the internal surfaces of a person's incisors and canines.
[0103] [0103] Figure 3A also shows continuous microspheres of an oral treatment composition 312 within an internal region or trough defined by the front side wall 304, rear side wall 306 and bottom wall 308. Figure 3B alternatively represents a layer substantially continuous of an oral treatment composition 312 'disposed within an internal region or chute defined by the front side wall 304, rear side wall 306 and bottom wall 308.
[0104] [0104] To protect oral treatment devices from contaminants during storage and before use, treatment devices can be packaged in a sealed container or package. As illustrated in Figures 4A and 4B, the exemplary sealed oral treatment packs 400, 400 'include an oral treatment device 402, 402' (e.g., dental impression trays) sealed within a protective package 404, 404 '. The protective packages 404, 404 'include a rigid support layer 406, 406' and a detachable 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'.
[0105] [0105] Figures 5A and 5B represent an embodiment of an oral treatment device in the form of a treatment strip, instead of a treatment tray. The oral treatment strip 500 includes a strip of wax-based material 502, which is initially substantially flat and may, optionally, have rounded corners. The strip of wax-based material 502 can be a single layer of wax-based material composed of a homogeneous mixture of wax and polymer. Coated on and / or impregnated in strips of wax-based material 502 is an oral treatment composition 504. The oral-treatment composition 504 can be a homogeneous material, uniformly and continuously coated over the strip of wax-based material 502.
[0106] [0106] Figures 6A and 6B illustrate an oral treatment device 600 applied and closely conforming to a tooth surface 602. The oral treatment device 600 may include a barrier layer in the form of a dental impression tray or strip-like sheet which is wound around tooth 602 to form a tray-like configuration. The oral treatment device 600 also includes an oral treatment composition that is capable of providing a desired treatment for the teeth and / or gums. Although the oral treatment device 600 is shown so that it only covers tooth 602 and not adjacent to soft oral tissue 604, it is within the scope of the description of oral treatment device 600 to extend beyond gingival margin 606 and at least partially overlap. the soft oral tissue 604.
[0107] [0107] Figures 7A-7E illustrate various modalities of strip-like barrier layers, which can be placed over the user's teeth and / or gums and adapted to engage and contact both the labial and lingual surfaces. Figure 7A illustrates an embodiment of a strip of wax-based material 700 having a substantially trapezoidal 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 7011 and second side 702 are generally straight sides that slope inwardly from the fourth side 704 towards the third side 703. The third side 703 can be concave and shorter than the fourth side 704, while the fourth side 704 can be convex. In use, the fourth side 704 can be placed adjacent to the gingival margin at an intersection between the user's teeth and gums. A fold line 705 can be included in strip 700, which extends from the first face 701 to the second side 702. Fold line 705 can be located closer to the third side 703 or the fourth side 704, depending on the size and width. desired shape of the device when folded during use. Folding line 705 can be determined by the size of a user's tooth and the manner of placing the oral treatment strip on the user's teeth. The third side 703 will be positioned adjacent to the lingual surfaces of the user's teeth by folding strip 700 along fold line 705.
[0108] [0108] Figure 7B illustrates another embodiment of a strip of wax-based material 720 that has a substantially trapezoidal shape, with staggered sides. The strip 720 has a first side 721, a second side 722, a third side 723 and a fourth side 724. The third side 723 can be concave and shorter than the fourth side 724. The fourth side 724 can be convex. The first side 721 and the second side 722 are both stepped sides that include inner corners 726 and 727, respectively. Fold line 725 typically extends between the inner corners 726, 727 of the steps on the first side 721 and the second side 722, respectively.
[0109] [0109] Figure 7C illustrates an alternative embodiment of a strip of material based on wax 730, which is substantially rectangular in shape with staggered sides. The strip 730 includes a first side 731, a second side 732, a third side 733 and a fourth side 734. The first side 731 and the second side 732 are both stepped sides that include inner corners 726 and 727, respectively. Fold line 735 extends from the corners 736 and 737 of the steps on the first side 731 and the second side 732, respectively. Fold line 35 can be placed over occlusal surfaces of a user's teeth, which allows strip 700 to bend around and over both the labial and lingual surfaces of the user's teeth. Strip 700 can be placed so that two of the user's canine teeth are just outside corners 736 and 737. The fourth side 734 can be located near the gingival margin on the front side of a user's teeth. The third side 733 will be located along the lingual surface of the user's teeth.
[0110] [0110] Figure 7D illustrates an alternative embodiment of a strip of material based on wax 740, which has a substantially rectangular shape, but with notched sides. The strip 740 has a first side 741, a second side 742, a third side 743 and a fourth side side 744. The third side 743 and the fourth 744 are both substantially straight sides and can be of the same length. The first side 741 and the second side 742 include notches 746, 747, respectively, which allow the occlusal surfaces of a user's canine teeth not to be covered when the strip 740 is placed over the user's teeth. A fold line 745 can extend from the notch 746 on the first side 741 to the notch 747 on the second side 742. The notches 746, 747 can have V-shaped sides, as shown. However, the notches can be of any desired shape, including rectangular, square, semicircular, oval and the like and which allows the tips of canine teeth to not be covered by the 740 strip when used over the user's teeth.
[0111] [0111] Figure 7E illustrates an alternative embodiment of a strip of wax-based material 750 that has a substantially rectangular shape, but with a fold line 755 between sides 756 and 757 in order to facilitate folding around the occlusal edges. of a user's teeth during installation. Once installed along a person's teeth, the strip or sheet 750 can hold an oral treatment composition against or close to the oral tissue to be treated.
[0112] [0112] The strip or flat sheet 750 illustrated in Figure 7E can be used for purposes other than to apply oral treatment agents. For example, the strip or sheet 750 can be used to record occlusal points during a dental examination procedure. The strip or sheet 750 can be made of a material based on deformable wax that can permanently deform and register the occlusal points, which allows a dentist to form a dental restoration in a suitable way for the restored tooth to contact and function properly together with a corresponding tooth during chewing
[0113] [0113] Figures 8A and 8B illustrate an exemplary oral treatment device or tray having a thick occlusal wall and thinner labial and lingual walls. A thick occlusal wall can provide several benefits, including providing additional wax-based material in regions that are likely to be deformed to the maximum during self-personalization and / or require an increased thickness to provide a desired function.
[0114] [0114] Figure 8A is a perspective view of an oral treatment device 800 comprising a barrier layer 802 having a generally horseshoe-shaped configuration defined by a lip wall 804, an occlusal wall 806 that extends laterally (for example, example, lingually) from the lip wall 804, and a lingual wall 808 that extends laterally (e.g., occlusally-gingivally) from the occlusal wall 806. The lip wall 804, occlusal wall 806, and the lingual wall 808, together, they define an 810 rail that has a generally U-shaped cross section.
[0115] [0115] Figure 8B is a cross-sectional view of the oral treatment device 800 of Figure 8A taken along line 8B-8B which schematically illustrates the thicknesses of the relative cross section 818 of the labial wall 804, occlusal wall 806 and the wall lingual 808. Lip wall 804 has a thickness of lip wall 812a, occlusal wall 806 has an thickness of occlusal wall 812b and lingual wall 808 has a thickness of lingual wall 812c. For application of compositions for oral treatment, the thickness of the lip wall 812a and / or the thickness of the lingual wall 812c can be in a range of about 0.001 ”to about 0.01", from about 0.002 ”to about 0.008 ", or about 0.004” to about 0.007 ". The thickness of the occlusal wall 812b can be in the range of about 0.002" to about 0.04 ", from about 0.005" to about 0.025 ", or about from 0.008 ”to about 0.015" and be at least about 25%, 30%, 40%, 50%, 75% or 100% greater than the thickness of the lip and / or lingual wall 812a, 812c.
[0116] [0116] In the case where the oral treatment device 800 is used for other purposes (for example, as a TMJ device, anti-smoking device, sports mouth guard, sports mouth guard coating, orthodontic protective tray, or surgical tray), the various wall thicknesses can be adjusted for the specific purpose for which the oral treatment device 800 is designed.
[0117] [0117] When the oral treatment device 800 is used as a TMJ tray, at least the occlusal wall 806 can have a thickness in the range of about 0.01 ”to about 0.2”, preferably in a range of about 0.025 "to about 0.15", and more preferably, in a range of about 0.05 "to about 0.1".
[0118] [0118] When the oral treatment device 800 is used as an anti-smoking tray, at least the occlusal wall 806 may have a thickness in the range of about 0.001 "to about 0.1", preferably in a range from about 0.005 "to about 0.08", and more preferably, in a range of about 0.01 "to about 0.05".
[0119] [0119] When the oral treatment device 800 is used as a mouth guard for sports, at least the occlusal wall 806 can have a thickness in a range of about 3 mm (about 1/8 ”) to about 6 mm (about 1/4 "), in order to protect teeth from blows or sharp impacts during sporting events. The 802 barrier layer can be formed by two-color molding, with a flexible but firm external protective mouth shell and durable, which is able to receive and distribute the impact forces that can occur during sporting events and that can be made from any suitable polymeric material, and a customizable inner layer made of a wax-based composition, such as described in the present invention, which can be customized by the user to register the user's unique dentition and maximize comfort and fit. In such cases, at least the portion of the outer shell of the occlusal wall 806 may have a thickness in a range of about 0.1 ” to about 0.3 ", preferably in a range of about 0.12" to about 0.275 ", and more preferably, in a range of about 0.14" to about 0.2 "and the inner customizable layer made of a wax-based composition can have a thickness in the range of about 0.005 "to about 0.15", preferably in the range of about 0.02 "to about 0.125" , and more preferably, in a range of about 0.02 ”to about 0.1”.
[0120] [0120] When the oral treatment device 800 is used as a customizable insert for a sports mouth guard, at least the occlusal wall 806 can have a thickness in the range of about 0.005 "to about 0.15", preferably, in a range of about 0.02 "to about 0.125", and more preferably, in a range of about 0.02 "to about 0.1".
[0121] [0121] Figures 8C and 8D illustrate an exemplary oral treatment device or tray pre-filled with a barrier layer that has a thick occlusal wall and thinner labial and lingual walls. Figure 8C is a perspective view of the pre-filled oral treatment device 800 including a flexible barrier layer 802 that has a generally horseshoe-shaped configuration defined by a lip wall 804, an occlusal wall 806 that extends laterally (for example, example, lingual) from the lip wall 804, and a lingual wall 808 that extends laterally (e.g., occlusally-gingivally) from the occlusal wall 806. The lip wall 804, occlusal wall 806 and the lingual wall 808 together define a trough 810 which has a generally U-shaped cross section and which maintains the oral treatment composition 814 therein. According to one embodiment, the oral treatment composition 814 may be a gel microsphere or viscous fixing mass.
[0122] [0122] Figure 8D is a cross-sectional view of the pre-filled oral treatment device 800 of Figure 8C taken along line-8D 8D which schematically illustrates the thicknesses of the relative cross-section 812 of the labial wall 804, occlusal wall 806 and lingual wall 808. Lip wall 804 has a thickness of lip wall 812a, occlusal wall 806 has an thickness of occlusal wall 812b and lingual wall 808 has a thickness of lingual wall 812c. The thickness of the lip wall 812a, the thickness of the occlusal wall 812b and the thickness of the lingual wall 812c can be as described in the present invention.
[0123] [0123] Figures 9A and 9B illustrate an exemplary pre-filled oral treatment device or tray with a barrier layer that has a thick occlusal wall and thinner labial and lingual walls. Figure 9A is a perspective view of the pre-filled oral treatment device 900 including a flexible barrier layer 902 that has a generally horseshoe-shaped configuration defined by a lip wall 904, an occlusal wall 906 that extends laterally (for example, example, lingually) from the labial wall 904, and a lingual wall 908 that extends laterally (e.g., occlusally-gingivally) from the occlusal wall 906. The labial wall 904, occlusal wall 906 and the lingual wall 908, in together, they define a trough 910 which has a generally U-shaped cross section and which maintains the oral treatment composition 914 therein. According to one embodiment, the oral treatment composition 914 may be substantially solid and / or initially dry to the touch, but it becomes more adherent to the teeth and / or gums when moistened with water or saliva.
[0124] [0124] Figure 9B is a cross-sectional view of the oral treatment device of the pre-filled 900 of Figure 9A taken along line 9B-9B which schematically illustrates the thicknesses of the relative cross section 912 of the labial wall 904, occlusal wall 906 and lingual wall 908. Lip wall 904 has a thickness of lip wall 912a, occlusal wall 906 has an thickness of occlusal wall 912b, and lingual wall 908 has a thickness of lingual wall 912c. The thickness of the lip wall 912a, the thickness of the occlusal wall 912b and the thickness of the lingual wall 912c can be as described in the present invention.
[0125] [0125] In an alternative embodiment, the oral treatment device 900 may alternatively include an absorbent coating 914, which contains in it a more fluid and less viscous oral composition.
[0126] [0126] Figures 10A and 10B illustrate an exemplary oral treatment device or tray that has a thick occlusal wall with a V-shaped protrusion and thinner labial and lingual walls. Figure 10A is a perspective view of an oral treatment device 1000 comprising a flexible barrier layer 1002, having a horseshoe-shaped configuration defined by a lip wall 1004, an occlusal wall 1006 that extends laterally (e.g. lingually) from the lip wall 1004, and a lingual wall 1008 that extends laterally (e.g., occlusally and gingivally) from the occlusal wall 1006. The labial wall 1004, the occlusal wall 1006 and the lingual wall 1008 together define a 1010 trough for receiving an oral treatment composition. The chute is further defined by a non-personalized V-shaped protrusion 1016 formed in the occlusal wall 1006, which is included in order to improve the fit between the occlusal wall 1006 and the indentations naturally found in the posterior teeth (that is, premolars) and molars). This, in turn, results in less deformation of the occlusal wall 1006 when customized to fit against a person's unique dentition.
[0127] [0127] Figure 10B is a cross-sectional view of the oral treatment device 1000 of Figure 10A taken along line 10B-10B which schematically illustrates the relative cross-section thicknesses 1012 of the labial wall 1004, the occlusal wall 1006 and the lingual wall 1008, as well as the V-shaped protrusion 1016 formed by occlusal wall 1006. Lip wall 1004 has a thickness of labial wall 1012a, occlusal wall 1006 has an occlusal wall thickness 1012b and lingual wall 1008 has a thickness lingual wall panel 1012c. The thickness of the lip wall 1012a and / or the thickness of the lingual wall 1012c can be in a range of about 0.001 "to about 0.01", from about 0.002 "to about 0.008", or about 0.004 "to about 0.007 ". The occlusal wall thickness 1012b can be in the range of about 0.002" to about 0.04 ", about 0.005" to about 0.025 ", or about 0.008" to about 0.015 "and be at least about 25%, 30%, 40%, 50%, 75% or 100% greater than the thickness of the lip and / or lingual wall 1012a, 1012c.
[0128] [0128] In the case where the oral treatment device 1000 is used for other purposes (for example, as a TMJ device, anti-smoking device, sports mouth guard, sports mouth guard coating, orthodontic protective impression or impression tray surgical), the various wall thicknesses can be adjusted for the specific purpose for which the oral treatment device 1000 is designed.
[0129] [0129] Figures 11A and 11B illustrate exemplary oral treatment devices or trays having a thick occlusal wall with thinner labial and lingual walls. Figure 11A illustrates an 1100 oral treatment device or barrier comprising a lip wall 1104, a thick occlusal wall 1106 that extends laterally (e.g., lingually) from the lip wall 1104, and a lingual wall 1108 that extends laterally (e.g., occlusally-gingivally) from occlusal wall 1106. The oral treatment device or barrier 1100 is shown installed on a tooth 1120 with an oral treatment composition 1114 positioned between the oral treatment device or barrier 1100 and the tooth 1120. Occlusal wall 1106 includes a V-shaped protrusion 1116 to better approximate the anatomy of tooth 1120, particularly with respect to recess 1122 on an occlusal surface 1124 of tooth 1120. V-shaped protrusion 1116 provides greater proximity between the occlusal wall 1106 and the occlusal surface 1124 of tooth 1120. When a user closes their mouth and places the posterior teeth in close contact, the pressure between the occlusal surfaces of the opposing tooth of the corresponding tooth is less likely to move the oral treatment device or barrier 1100 out of its correct position in relation to tooth 1120 (for example, as a result of the occlusal wall 1106 being pushed further in the recess 1122 in order to pull the lip wall 1104 and / or the lingual wall 1108 down in relation to the tooth 1120).
[0130] [0130] Figure 11B illustrates an oral treatment device or barrier 1140 comprising a lip wall 1144, a thick occlusal wall 1146 that extends laterally (e.g., lingually) from the lip wall 1144 and a lingual wall 1148 that extends extends laterally (e.g., occlusally and gingivally) from the occlusal wall 1146. The oral treatment device or barrier 1140 is shown installed on a tooth 1160, with an oral treatment composition 1154 positioned between the oral treatment device or barrier 1140 and the tooth 1160. The thick occlusal wall 1146 has a thicker cross section than the lip wall 1144 and the lingual wall 1148 to provide a greater amount of deformable and / or protective wax-based material in the vicinity of the 1164 edge or occlusal surface. tooth 1160. The largest amount of wax-based material in the occlusal wall 1146 resists perforation when the occlusal edge or surface 1164 of tooth 11 60 comes into contact with a secondary surface, such as an opposite occlusal edge of a corresponding tooth or an object placed in a person's mouth.
[0131] [0131] Figure 12 illustrates an oral treatment device or barrier 1200 that comprises a lip wall 1204, a thick occlusal wall 1206 that extends laterally (e.g., lingually) from the lip wall 1204, and a lingual wall 1208 that extends laterally (e.g., occlusally and gingivally) from the occlusal wall 1206. The oral treatment device or barrier 1200 is shown installed on a tooth 1220, with an oral treatment composition 1214 positioned between the oral treatment device or barrier 1200 and tooth 1220. Lip wall 1204 has an improved curvature, which is closer to the anatomy of tooth 1220, particularly with regard to the curvature of facial surface 1226 of tooth 1220. The increased curvature of lip wall 1204 provides greater proximity and better fit between the labial wall 1204 and the facial surface 1226 of tooth 1220. This, in turn, helps to retain the oral treatment device 12 00 in the appropriate position in relation to the tooth 1220 and resist the displacement or sliding of the treatment device 1200 which may otherwise result from compression and / or lateral forces applied to the lip wall 1204 during its use (for example, by person's lip or cheek).
[0132] [0132] Figure 13 illustrates an oral treatment device or barrier 1300 comprising a lip wall 1304, a thick occlusal wall 1306 that extends laterally (e.g., lingually) from the lip wall 1304, and a lingual wall 1308 that extends laterally (for example, occlusally and gingivally) from occlusal wall 1306. In this embodiment, labial wall 1304 and lingual wall 1308 cover only part of a patient's teeth (for example, to provide a barrier or desired protection, minimizing device interference The 1300 oral treatment device or barrier is shown to be installed over a portion of the 1320 tooth.
[0133] [0133] Alternatively, oral treatment devices (not shown) may have the labial wall extending beyond the gingival margin and have a curvature at least partially corresponding to a curvature of a labial surface of the skeletal maxilla or alveolar ridge in order to improve the fit between the dental treatment device and a person's dental arch when in use. V. EXAMPLES
[0134] [0134] The following are examples of wax-based compositions that can be used for the manufacture of oral treatment devices, including dental impression trays and strip-like barrier layers. Exemplary formulations and manufacturing conditions are given by way of example and not by limitation. Unless otherwise stated, all percentages are by weight. COMPARATIVE EXAMPLE
[0135] [0135] A sheet of Parafilm® M was thermoformed in a dental treatment tray by heating the sheet to a softening temperature and then vacuum molding the softened sheet onto a mold that is shaped like a dental treatment tray. The resulting dental treatment tray was able to maintain its shape as a tray at room temperature and can be used as a barrier layer in an oral treatment tray. However, the tray did not show thermal stability and lost dimensional stability at temperatures of about 100 ° F (about 38 ° C) or above. As a result, it was determined that dental impression trays performed by thermoforming of Parafilm® M were unsuitable for use in the manufacture of oral treatment devices that are subjected to higher temperatures during transport and storage (that is, up to 50 ° C ).
[0136] [0136] The dental trays in the following examples were or are produced by injection molding a wax-based composition, as described below. The wax-based composition of each example was or is initially formed by introducing the materials into a twin screw extruder having multiple zones, heating, and mixing the materials in the extruder, extruding the composition into a chain, cooling the extruded filament in one water bath, and cut the filament into pellets. The pellets were or are then fed to an injection molding machine and injection molded into dental trays. The injection molding machine was set up to initially heat the wax-based composition prior to introduction into the mold cavity and then cool the material to form the solidified trays. Injection-molded trays had an average side wall thickness of about 0.007-0.008 mil (about 0.18-0.2 mm), with thick occlusal surfaces of about 0.010-, 013 mil (25-33 mm) .
[0137] [0137] Dental treatment trays produced according to Examples 1-10 had varying levels of thermal stability, plastic deformation and comfort. All had better thermal stability compared to the thermoformed tray of the Comparative Example, even the injection molded tray of Example 1, which was made by injection molding the composition of Parafilm® M. As a comparison, the tray of Example 1, made by injection molding of 100% Parafilm® M, was dimensionally stable up to a temperature of about 50-52 ° C. As the amount of Parafilm® M has been reduced and replaced by other components, such as paraffin wax, polyolefin thermoplastic elastomer and / or distilled wax, the temperature stability of the trays has increased with the increase in the ability of the trays to be deformable plastically in a user’s mouth.
[0138] [0138] Dental treatment trays produced according to Examples 11-19 had varying levels of thermal stability, plastic deformation and comfort. Trays produced according to Examples 11-19 had improved thermal stability compared to the tray of Comparative Example. By reducing the amount of Parafilm® M and replacing with other components, such as paraffin wax and / or distilled wax, temperature stability and the ability of the trays to be plastically deformable in a user's mouth has been increased.
[0139] [0139] Dental treatment trays produced according to Examples 20-28 provided improved thermal stability and plastic deformation compared to the tray produced according to Comparative Example.
[0140] [0140] Dental treatment trays produced according to Examples 29-38 provided improved thermal stability and plastic deformation compared to the tray produced according to Comparative Example.
[0141] [0141] Dental treatment trays produced according to Examples 39-48 provided improved thermal stability and plastic deformation compared to the tray produced according to Comparative Example.
[0142] [0142] Dental treatment trays produced according to Examples 49-58 provided improved thermal stability and plastic deformation compared to the tray produced according to Comparative Example. EXAMPLE 59
[0143] [0143] Any of the compositions of Examples 2-58 is extruded or otherwise formed on a sheet that has a thickness so as to be thermoformable and then a tray formed using a thermoforming technique known in the art. Trays formed according to Example 59 provided better thermal stability and plastic deformation compared to the tray produced according to Comparative Example.
[0144] [0144] The present invention can be realized in other specific forms without distancing itself from its spirit or essential characteristics. The described modalities should be considered in all aspects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims and not by the previous description. All changes that are part of the meaning and equivalence range of the claims must fall within its scope.
[0145] [0145] What is claimed is:

权利要求:
Claims (30)
[0001]
Oral treatment device, CHARACTERIZED by the fact that it comprises: a wax-based composition having a three-dimensional shape selected from a therapeutic tray, anti-smoking tray, treatment tray for temporomandibular joint disorders (TMJ), mouth guard for sports, mouth guard insert for sports, orthodontic guard tray, post-surgical oral protection device, or deformable device for recording occlusal points on a patient's teeth, wherein the wax-based composition is comprised of: more than 50% and up to 93% by weight of a wax fraction comprising paraffin wax and microcrystalline wax; and thermoplastic elastomer.
[0002]
Oral treatment device according to claim 1, CHARACTERIZED by the fact that the oral treatment device comprises a thick occlusal wall configured to contact an occlusal edge or surface of one or more teeth and thinner labial and lingual walls adjacent to the thick occlusal wall.
[0003]
Oral treatment device according to claim 1 or 2, CHARACTERIZED by the fact that the oral treatment device is thermally stable at a temperature of at least 45 ° C and plastically deformable at 25 ° C.
[0004]
Oral treatment device according to any one of claims 1 to 3, CHARACTERIZED by the fact that the wax fraction is included in a range of 60% to 90% by weight of the wax-based composition.
[0005]
Oral treatment device according to claim 4, CHARACTERIZED by the fact that the wax fraction is included in a range of 75% to 85% by weight of the wax-based composition.
[0006]
Oral treatment device according to any one of claims 1 to 5, CHARACTERIZED by the fact that the wax fraction is substantially homogeneously mixed with the thermoplastic elastomer.
[0007]
Oral treatment device according to any one of claims 1 to 6, CHARACTERIZED by the fact that the thermoplastic elastomer is included in a range of 5% to 50% by weight of the wax-based composition.
[0008]
Oral treatment device according to claim 7, CHARACTERIZED by the fact that the thermoplastic elastomer is included in a range of 10% to 40% by weight of the wax-based composition.
[0009]
Oral treatment device according to any one of claims 1 to 8, CHARACTERIZED by the fact that the thermoplastic elastomer comprises a polyolefin thermoplastic elastomer, such as a propylene-based elastomer.
[0010]
Oral treatment device according to claim 9, CHARACTERIZED by the fact that the polyolefin thermoplastic elastomer comprises a propylene-based elastomer.
[0011]
Oral treatment device according to any one of claims 1 to 10, CHARACTERIZED by the fact that the wax-based composition consists essentially of paraffin wax, microcrystalline wax, and thermoplastic elastomer.
[0012]
Oral treatment device according to any one of claims 1 to 11, CHARACTERIZED by the fact that the oral treatment device is a therapeutic tray designed for use by disabled, geriatric, or sick patients.
[0013]
Oral treatment device according to any one of claims 1 to 12, CHARACTERIZED by the fact that it further comprises an oral treatment composition adjacent to, or impregnated in, a three-dimensional shape.
[0014]
Kit for providing oral treatment, CHARACTERIZED by the fact that it comprises the oral treatment device, as defined in any one of claims 1 to 12, and an oral treatment composition initially separate from the oral treatment device.
[0015]
Method of manufacturing an oral treatment device, CHARACTERIZED by the fact that it comprises: combining paraffin wax, microcrystalline wax, and thermoplastic elastomer to form a mixture comprising more than 50% and up to 93% by weight of a fraction of wax comprising paraffin wax and microcrystalline wax; processing the mixture to form a wax-based composition comprised of the wax fraction mixed with the thermoplastic elastomer; and form the wax-based composition into a three-dimensional form selected from a therapeutic tray, anti-smoking tray, treatment tray for temporomandibular joint disorders (TMJ), mouth guard for sports, mouth guard insert for sports, orthodontic guard tray , post-surgical oral protection device, or deformable device for recording occlusal points on a patient's teeth.
[0016]
Method according to claim 15, CHARACTERIZED by the fact that paraffin wax, microcrystalline wax and thermoplastic elastomer are processed using an extruder to form the wax-based composition on a sheet or wire.
[0017]
Method according to claim 15 or 16, CHARACTERIZED by the fact that the wax-based composition is injection molded into the three-dimensional shape.
[0018]
Method according to any one of claims 15 to 17, CHARACTERIZED by the fact that the processing includes heating the mixture to a temperature in the range of about 50 ° C to about 225 ° C.
[0019]
Method according to any one of claims 15 to 18, CHARACTERIZED by the fact that the processing includes applying pressure to the mixture in a range of about 1000 psi to about 30,000 psi.
[0020]
Use of a wax-based composition, CHARACTERIZED by the fact that it is for the preparation of a treatment or therapeutic device used to deliver therapy or treatment to a patient's oral cavity, the wax-based composition comprising paraffin wax, wax microcrystalline, and thermoplastic elastomer.
[0021]
Use according to claim 20, CHARACTERIZED by the fact that the treatment or therapeutic device comprises a thick occlusal wall configured to contact an occlusal edge or surface of one or more teeth and thinner labial and lingual walls adjacent to the thick occlusal wall.
[0022]
Use, according to claim 20 or 21, CHARACTERIZED by the fact that the treatment or therapeutic device is a therapeutic tray designed to be used by disabled, geriatric, or sick patients.
[0023]
Use according to claim 20 or 21, CHARACTERIZED by the fact that the treatment or therapeutic device provides an anti-smoking effect.
[0024]
Use, according to claim 20 or 21, CHARACTERIZED by the fact that the treatment or therapeutic device provides treatment for temporomandibular joint disorder (TMJ).
[0025]
Use, according to claim 20 or 21, CHARACTERIZED by the fact that the treatment or therapeutic device protects an athlete's teeth during a sporting event.
[0026]
Use, according to claim 25, CHARACTERIZED by the fact that the treatment or therapeutic device comprises a mouthguard for sports or insertion for a mouthguard for sports.
[0027]
Use according to claim 20 or 21, CHARACTERIZED by the fact that the treatment or therapeutic device protects a patient's oral soft tissue after an orthodontic procedure.
[0028]
Use, according to claim 20 or 21, CHARACTERIZED by the fact that the treatment or therapeutic device protects a patient's mouth after oral surgery.
[0029]
Use, according to claim 20 or 21, CHARACTERIZED by the fact that the treatment or therapeutic device registers occlusal points of the patient's teeth.
[0030]
Use according to claim 20 or 21, CHARACTERIZED by the fact that it further comprises an oral treatment composition adjacent to, or impregnated in, the wax-based composition.

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同族专利:

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KR20210002366A|2021-01-07|

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KR20160070108A|2016-06-17|

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US10913853B2|2021-02-09|

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WO2015053808A1|2015-04-16|

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法律状态:
2018-11-13| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

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2020-04-28| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2021-02-09| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2021-03-23| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 07/03/2014, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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申请号 | 申请日 | 专利标题

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US201361889880P| true| 2013-10-11|2013-10-11|

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US61/889,880|2013-10-11|

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PCT/US2014/022053|WO2015053808A1|2013-10-11|2014-03-07|Wax-based compositions, articles made therefrom, and methods of manufacture and use|

---