Dental treatment trays comprising silicone or other elastomeric material

The present invention relates to dental treatment trays used to deliver oral treatment compositions.

Common bleaching methods include the use of custom dental trays adapted to each user's unique dentition shape. One way to form a custom tray is to vacuum form a sheet of moisture resistant thermoplastic polymer on a plaster model or a human tooth model and then trim the excess tray material. Another method uses human teeth as a mold (eg, a "boil and bite" tray). Custom-made dental trays made and sold by dentists are formed using plaster models of human teeth and typically cost hundreds or thousands of dollars.

Other methods include flexible strips and non-custom-made trays that can be approached to dental arches of various sizes and shapes and are substantially less expensive to manufacture than custom-made trays. The dental bleaching composition is placed on a strip or in a tray and then on a person's teeth for a desired period of time. To attach the bleaching strip, a portion of the bleaching strip is mounted over the anterior surface of the user's teeth and the rest is folded around the occlusal edge of the tooth and against a portion of the lateral side of the tongue. It is often difficult for the user to keep the bleach strip in place for the recommended period of time due to the generally poor adhesion of the bleach strip to the user's teeth and the generally fragile nature of the strip. .. Traditional bleach strips are prone to slip off teeth, even with minimal movement of the user's mouth, jaw, or tongue. Bleach strips are very often dislodged or ragged, so the user may have to remove the bleach strip and replace it with a new bleach strip to complete the recommended bleaching period.

Non-custom dental trays generally have the drawback of poor fit to the user's teeth. Some non-custom dental trays are flexible enough to fit into dental arches of different sizes and shapes within a range of sizes and shapes, but existing non-custom trays, especially the outside. Tray that is used without a support tray and therefore must be self-supporting cannot comfortably fit excessively sized or shaped dental arches (ie, significantly larger, smaller, or particularly misaligned teeth). Moreover, existing free-standing trays are difficult to adapt and adapt to the ridges, recesses, and contours of individual human teeth, in addition to adapting to the overall shape and size of the human dental arch. .. These shortcomings form a bridge that straddles the outermost surfaces of adjacent teeth and / or all that the tray wall is aligned rather than simply corresponding to the largest or most curved tooth. Due to the inability to fit the teeth exactly, there is easily a large gap between the walls of the non-custom tray and the human teeth, especially the space between the individual teeth, during use. Such gaps allow saliva to easily penetrate into the dental tray and / or the dental bleaching composition to be pushed out of the dental tray during use.

In addition, the inability of the front and back walls of existing non-custom trays to adapt and adapt to the ridges, recesses, and contours of a person's individual teeth means that most of each wall is subject to external pressure (eg, for example). It means that the person's lips or tongue (the person's lips or tongue) pressing on the outer surface of the tray wall tend to move in unison. The movement of the localized area adjacent to one tooth of the free-standing tray generally simultaneously causes the movement of the tray wall in the adjacent area where such movement may be undesirable. This exacerbates the above-mentioned tendency that, in addition to the formation of large gaps, saliva penetrates into the gap between the tray wall and the human teeth and / or the bleaching composition is extruded from the dental tray. Pumping action may be produced.

Low Density Polyethylene (LDPE), Ultra Low Density Polyethylene (ULDPE), Ethylene Vinyl Acetate Copolymer (EVA), Polycaprolactone (PCL), Other Types of Polyethylene (PE), Polypropylene (PP), Polyester, Polycarbonate, Polyethylene, Polyethylene , Polyethyleneamide, and copolymers thereof, self-supporting, non-custom dental trays made from thermoplastic materials are disclosed in Patent Documents 1 and 2 (Andersen Patent). When used in the manufacture of relatively thick (ie, greater than 2 mm) dental treatment trays, the above materials form trays that are very stiff and can only be made to order to fit the user's teeth. .. Andersen therefore discloses non-custom free-standing trays with thin walls (ie less than about 1 mm). This makes the tray flexible enough to adapt to a range of different sizes and shapes of dental arches without the need for formal build-to-order manufacturing. Andersen's free-standing trays are a significant advancement in the art compared to traditional free-standing dental trays, but such trays are the ridges, recesses, and recesses of a person's individual teeth. It does not easily and accurately adapt to the contours. Rather, they generally form bridges between the individual teeth that may straddle the interdental recesses. They also have areas of the tray wall that tend to move partially in unison rather than adapting to the contours of the individual teeth.

In addition, the ability to inject dental trays from the types of thermoplastic materials disclosed in the Andersen patent is limited (ie, practically for the thinness that allows such trays to be successfully injection molded). There is a limit). Therefore, dental trays with very thin walls (ie, less than about 5 mm) must be formed by other methods, such as vacuum forming a thin polymer sheet on a mold.

Patent Document 3 ("Fischer Patent") teaches that an attempt to improve Andersen's manufacturing method contains a large amount (eg, 20-50% by weight) of a hydrophobic oily plasticizer (eg, mineral oil). .. The inclusion of a relatively large amount of plasticizer significantly reduces the thickness of the dental tray that can be injection molded. For example, the Fischer patent allows for the first time to manufacture trays with wall thicknesses less than about 0.015 inches (ie, about 0.4 mm). In addition, the inclusion of a plasticizer such as mineral oil results in a dental tray that is more flexible and flexible than a dental tray made from a plasticizer-free thermoplastic polymer. However, it was found that even hydrophobic plasticizers such as mineral oil tend to bloom (ie, move to the surface) over time. Such blooming causes the dental tray to have an unpleasant taste, making it difficult for the hydrophilic dental bleaching composition to adhere to the surface of the dental tray. The inability to easily adhere the adhesive dental bleaching composition to the tray surface generally reduces the adaptability and adaptability of the tray to human teeth.

Finally, the main obstacle to successful bleaching is the inability of the user to complete the prescribed bleaching regimen. If it is difficult to put the bleaching device on a person's teeth, if it needs to be repeated many times to get visible results, or if it feels uncomfortable, the user simply gives up on the prescribed bleaching regimen and May be interrupted early. Therefore, even if dental bleaching is possible using a particular bleaching device or method, bleaching can be done if the user is discouraged before achieving the desired result due to the shortcomings of the bleaching device or method. Is less likely to occur. One commercially successful, pre-filled, self-contained tray device manufactured according to Andersen has been very successful. Customer satisfaction is generally high. However, the main complaint with such devices is the inability to adapt and fit the user's teeth like custom trays.

<p><patcit num="1"><text>U.S. Pat. No. 6,964,571</text></patcit><patcit num="2"><text>U.S. Pat. No. 7,004,756</text></patcit><patcit num="3"><text>U.S. Pat. No. 7,137,814</text></patcit><patcit num="4"><text>U.S. Pat. No. 5,376,006</text></patcit><patcit num="5"><text>U.S. Pat. No. 5,785,527</text></patcit><patcit num="6"><text>U.S. Pat. No. 5,851,512</text></patcit><patcit num="7"><text>U.S. Pat. No. 5,858,332</text></patcit><patcit num="8"><text>U.S. Pat. No. 5,985,249</text></patcit><patcit num="9"><text>U.S. Pat. No. 6,306,370</text></patcit><patcit num="10"><text>U.S. Pat. No. 6,309,625</text></patcit><patcit num="11"><text>U.S. Pat. No. 6,312,671</text></patcit><patcit num="12"><text>U.S. Pat. No. 6,322,774</text></patcit><patcit num="13"><text>U.S. Pat. No. 6,368,576</text></patcit><patcit num="14"><text>U.S. Pat. No. 6,387,353</text></patcit><patcit num="15"><text>U.S. Pat. No. 6,500,408</text></patcit><patcit num="16"><text>U.S. Pat. No. 6,503,485</text></patcit><patcit num="17"><text>U.S. Patent Application No. 11 / 460,016</text></patcit></p>

<p> As a result, in terms of regimen completion and results, the use of expensive custom-made dental trays remains the most reliable method of dental bleaching. Non-custom commercial bleached strips and trays are relatively inexpensive, but generally perform poorly when compared to custom-fitted trays.</p>

<p> The present invention generally relates to highly compatible and adaptable dental treatment trays used for delivering dental treatment compositions (eg, dental bleaching compositions) to human teeth. Non-custom trays are highly adaptable, so they easily and accurately adapt and adapt to the ridges, recesses, and contours of a person's individual teeth. They can also adapt and adapt to a wide variety of different sizes and shapes of dental arches, even excessively sized and shaped dental arches. This is true even when the tray is designed to be self-supporting. In use, a highly compatible and adaptable dental treatment tray provides results that can be characterized as a "semi-custom dental tray". The result is a non-custom dental tray that is more comfortable than existing dental trays or treatment strips and fits the user's teeth like a custom made dental tray. Unlike dental strips, which often come off more easily than trays during use, highly compatible dental trays are flexible and extremely comfortable to wear, while maintaining the shape of the tray during use. Has sufficient elastic properties. This greatly improves the ability to stay in place during treatment compared to conventional bleached strips made from thin, flexible, thermoplastic polymer sheets.</p><p> The disclosed non-custom dental treatment tray embodiments are elastomeric silicone or other highly elastomeric material exhibiting properties similar to silicone (eg, styrene-ethylene-butylene-styrene (SEBS), and similar to silicone. It is formed from VERSAflex), a registered trademark of thermoplastic elastomer alloys that exhibit elastic elongation and other properties. VERSAflex is sold by GLS Corporation, based in McHenry, Illinois. SEBS and VERSAflex are particularly useful examples of thermoplastic elastomers that exhibit similar properties to silicones and can be referred to below as "elastomer silicone-like materials". The terms "elastomer" and "elastomer silicone-like material" include thermoplastic and thermosetting materials.</p><p> Since the disclosed trays are made from highly elastomeric materials, they easily stretch elastically. This property of high elastic elongation is lacking in the non-elastomeric or low thermoplastic polymers used to make conventional trays and strips, and the disclosed trays are human tooth ridges, It allows for a closer fit to recesses and contours, as well as to dental arches of significantly different sizes and shapes.</p><p> Unlike traditional thermoplastic materials used to form boiled and bite dental trays, both elastomeric silicones and "elastomer silicone-like materials" are boiled in water to form custom-made dental trays. It does not soften sufficiently by doing so. In fact, since cured silicones or other thermosetting elastomers are not thermoplastic materials, non-custom dental trays made from them generally do not soften on heating. Thermoplastic elastomers generally soften only at temperatures well above the boiling point of water. Such materials cannot be made into custom-made dental trays in this way. Therefore, non-custom dental trays exhibit higher thermal stability compared to traditional thermoplastic trays and strip materials.</p><p> Elastomer materials exhibit excellent compatibility, flexibility, elastic elongation, and flexibility, while also exhibiting elasticity (ie, the ability to spring back to their original configuration when released from deforming forces). .. The combination of such properties provides a high level of shape fitting and user comfort. Dental trays made from elastomeric silicone or silicone-like materials exhibit these beneficial characteristics at higher wall thicknesses, thus reducing weakness compared to thinner wall thickness trays and strips. It can have the additional advantage of being made and is easier to install. In other words, dental treatment trays made from elastomeric silicone or elastomeric silicone-like materials and having a given wall thickness are of the same thickness formed from thermoplastic materials commonly used to make existing dental trays. Shows higher compatibility, flexibility, and flexibility than trays. In addition, the disclosed trays exhibit excellent elastic elongation and elasticity that are lacking in existing non-custom dental trays and strips made from thermoplastic polymers, even with the addition of large amounts of plasticizer ( That is, the plasticizer can soften the thermoplastic material but cannot convert it to an elastomer).</p><p> Elastomer silicones and silicone-like materials also exhibit higher surface adhesion compared to the thermoplastic materials used to make conventional dental trays and strips. Due to such high surface adhesion, the disclosed dental trays can be more easily adhered to the surface of human teeth, and / or a viscous, viscous dental treatment composition is in close proximity to the surface of the tray. As it will be placed, it will be more compatible. Surface adhesive strength of dental trays made from elastomeric silicones and silicone-like materials, especially when used with sticky, viscous dental bleaching compositions, tray compatibility and adaptability compared to conventional trays The sex becomes even higher. For example, conventional non-custom dental trays can move against the teeth, causing saliva influx and / or outflow of dental treatment composition. What's worse, conventional dental bleaching strips have poor adhesion to the teeth during use, easily slip off, and / or easily become ragged, making them practically unsuitable for use. Providing trays made from elastomeric silicones and silicone-like materials provides significant improvements in the ability of conventional trays and strips to stay in place during use.</p><p> Elastomer silicones and silicone-like materials are generally more expensive than traditional thermoplastics, but given the overall cost, they provide a net manufacturing cost savings. Thermoplastic materials are difficult to injection mold, especially on thin cross sections (ie, less than 0.5 mm), which means that traditional dental trays are generally formed by molding and / or cutting from sheet material. .. This greatly complicates the manufacturing process. Forming dental trays by injection molding significantly reduces costs. Moreover, according to the inventor's actual experience, the labor cost of producing a relatively comfortable thin wall thickness (eg, about 0.4 mm) dental treatment tray from a plastic thermoplastic material is very high. Due to its large size, it is clear that by forming the dental tray from an elastomeric silicone or silicone-like material, cost savings and improved features can be achieved. More expensive silicones and other elastomeric materials can be injection molded into dental trays while reducing overall manufacturing costs compared to forming trays from cheaper non-elastomer thermoplastic polymers. Is a surprising and unexpected result.</p><p> In general, elastomeric silicones and silicone-like materials can be injection molded with little or no plasticizer. Thus, in one embodiment, the dental tray can be formed essentially or exclusively from a material consisting of silicone or other elastomeric material. Eliminating the plasticizer greatly simplifies production because only the silicone material (eg, provided as a thermosetting two-part liquid composition for medical use) is required. Also, by eliminating the plasticizer, the blooming of the plasticizer is eliminated, the taste of the molded tray is improved, and the adhesive strength to the dental and dental treatment compositions is also increased.</p><p> SEBS, VERSAflex, and other exemplary thermoplastic elastomers can be mixed with small amounts of auxiliary ingredients, but such other materials are commonly used compositions for making dental trays. Less than about 10% by weight, preferably less than about 5% by weight, more preferably less than about 3% by weight, even more preferably less than about 1% by weight, most preferably 0% by weight.</p><p> When used to deliver a dental treatment composition to a person's teeth, and when it is desirable to maximize compatibility, adaptability, and comfort, the disclosed dental trays generally have a wall thickness. It is less than about 1 mm, preferably in the range of about 0.03 mm to about 1 mm, more preferably in the range of about 0.05 mm to about 0.75 mm, most preferably in the range of about 0.1 mm to about 0.5 mm.</p><p> Dental trays with a wall thickness greater than 1 mm are generally less comfortable and fit than the more preferred thinner wall thickness dental trays. This is especially true when using elastomeric materials of the same Shore A hardness. However, unlike the thermoplastic materials used to make traditional dental trays, Shore A hardness elastomeric materials remain more wall compatible and adaptable to the user's teeth. It can be operated more easily (eg, reduction) to form a thick dental tray. Thus, dental trays that are greater than 1 mm thick (eg, up to about 1.5 mm) but still exhibit high compatibility, adaptability, and comfort are within the scope of the present invention.</p><p> The durometer hardness / flexibility of elastomeric silicones or other elastomeric materials is advantageously selected to balance flexibility with wall thickness. Within the above preferred wall thickness range (ie, from about 0.03 mm to about 1 mm), Shore A durometer hardness values are preferably in the range of about 90 to about 20. In general, higher durometer values (less flexible) are preferred (eg, flexible) when making trays with thinner walls (eg, to maintain good elasticity and springback properties). For trays with thicker walls (to maintain resilience, high suitability, and comfort), lower durometer values (more flexible) are preferred. For example, a tray with a wall thickness of about 0.25 mm can advantageously have a Shore A durometer hardness value of about 40, whereas a tray with a wall thickness of about 0.1 mm has a Shore A durometer hardness value of about 40. Can be 70. On the other hand, a non-custom tray with a thickness of 1.5 mm can advantageously have a Shore A hardness of about 10.</p><p> The dental treatment trays disclosed herein are not made to order. That is, they do not have the depressions or other features that correspond to the user-specific dentition prior to attachment to the user's teeth. Thus, they can fit and fit the contours of a wide variety of different sizes and shapes of dental arches. However, the dental trays disclosed herein are extremely adaptable and adaptable, especially when used in combination with sticky dental treatment compositions and adhesives such as glue. Non-custom dentistry, mounted on the user's teeth and manipulated to adapt to the ridges, recesses, and contours of the user's teeth (eg, by pressing with fingers and / or the user's lips) The tray for use has almost the same performance as the tray made to order. In use, these can be considered semi-custom trays. However, these are not "made-to-order" as the traditional meaning of the word. Because when removed from the user's teeth, the depressions or other features that correspond to the user's unique dentition disappear and are used for another person's teeth (at least in theory, if hygiene is not considered). However, it is possible to show the same semi-custom-made feel and performance. It is not possible for the highly compatible and adaptable non-custom dental trays disclosed herein to behave like semi-custom dental trays in use, even though they are non-custom made. This is a surprising and unexpected result when compared to traditional non-custom made dental trays made from elastomeric thermoplastic polymers.</p><p> These and other advantages and features of the present invention will be more fully apparent from the following description and the appended claims, or will be known from the examples of the invention described below.</p><p> To further clarify the above and other advantages and features of the invention, a more detailed description of the invention is provided below with reference to the particular embodiments illustrated in the accompanying drawings. It should be understood that these drawings only show typical embodiments of the invention and should therefore not be considered limiting the scope of the invention. The present invention will be described and described in more detail and in detail with reference to the following drawings.</p>

<figref num="1">FIG. 3 is a perspective view of an exemplary non-custom dental treatment tray according to the present invention.</figref><figref num="2A">An exploded view of an alternative dental treatment tray, including anatomical features to enhance fit in conjunction with any complementary outer support tray.</figref><figref num="2B">FIG. 2 is a perspective view showing the dental treatment tray of FIG. 2A nested within the outer support tray of FIG. 2A.</figref><figref num="3">FIG. 5 is a perspective view showing a pair of tray assemblies similar to the assembly of FIG. 2B, housed in a sealed protective package with a removable cover.</figref><figref num="4A">It is a figure which shows the person who attaches the dental treatment tray by this invention on the maxillary dental arch.</figref><figref num="4B">It is a figure which shows the dental treatment tray by this invention attached to both the maxillary dental arch and the mandibular dental arch in place.</figref>

I. Introduction Preferred embodiments of the present invention include highly compatible dental treatment trays used to deliver dental treatment compositions (eg, dental bleaching compositions) to human teeth. Preferred trays are also highly compatible with the ridges, recesses, and contours of a person's individual teeth, as well as a wide variety of different sizes and shapes of dental arches, and easily and accurately fit and adapt. A tray that is highly compatible and adaptable in use can be characterized as a "semi-custom dental tray".

Surprisingly and unexpectedly, trays made of elastomeric silicone or silicone-like materials also produce trays while also exhibiting high elasticity (ie, the ability of the tray structure to spring back into place). Very high adaptability (ie, non-custom trays, in use, individual tooth ridges, recesses, and contours of a person, compared to conventional thermoplastic materials used for (eg EVA materials). Has the ability to shape and adapt to the shape). As a result, non-custom dental trays made from thermosetting elastomeric silicones, other thermosetting elastomers, or thermoplastic elastomers are compared to existing pre-filled dental trays and bleaching strips. The bleaching experience can be greatly improved and the regimen can be more reliably adhered to.

Surprisingly and unexpectedly, the disclosed trays bring the experience of using custom-made dental trays very close, at a fraction of the cost of manufacturing custom-made dental trays. be able to. To manufacture custom-made dental trays, take the impression of each patient's teeth and form a plaster model for each patient, then form a custom-made tray from the plaster model for each patient. There is a need to. Conversely, non-custom made trays disclosed herein, in order to fit a wide variety of different sizes and shapes of teeth and the dental arch, (e.g., injection molding by the shape) can be mass produced ..

Another surprising and unexpected feature is that the disclosed dental trays are made from conventional thermoplastic polymers with little or no elastomeric properties, compared to thinner wall non-custom dental trays. It is possible to show higher adaptability and adaptability to human teeth even when the wall thickness is thicker. This has the added benefit of reducing weakness, allowing the disclosed trays to be installed more easily (ie, easily installed without the assistance of outer support trays) and stay in place. become. In other words, an elastomeric silicone or silicone-like dental treatment tray with a given wall thickness is at least as good as, generally much more than, a thinner tray formed from a conventional thermoplastic material (eg EVA). Shows high compatibility, flexibility, and flexibility. In addition, dental trays made from elastomeric silicone or silicone-like materials exhibit elasticity and elastic elongation, properties that trays made from other materials lack. The unique combination of properties increases user comfort and improves adherence to a given treatment regimen.

The disclosed trays are the individual teeth of a person, as opposed to trays made from non-elastomer polymers, which do not stretch elastically during use and therefore tend to form bridges across the gaps between individual teeth. It has a high elastic elongation that allows it to fit and adapt more closely to the valleys, recesses, and contours of the tooth. Non-elastomer polymer trays, no matter how flexible, may disengage from other teeth and / or stretch like bridges over other teeth if they cannot stretch elastically. Without being able to fit into the recesses between some teeth. Compared to existing non-custom dental trays, the disclosed trays have some tooth valleys, without disengagement from other teeth and / or stretching like a bridge over other teeth. It can be easily adapted and adapted to recesses and contours. This is a surprising and unexpected result compared to existing non-custom dental trays.

II. Illustrative dental trays made from elastomeric silicones and silicone-like materials FIG. 1 shows an exemplary non-custom dental tray 100 that can be formed by liquid injection molding an elastomeric silicone or silicone-like material. For example, the elastomeric silicone material can initially include a two-part composition comprising a first part containing one or more siloxanes and a second part containing an activator. When the two liquid parts are mixed together, the siloxane component polymerizes and crosslinks to form a polysiloxane. Heat can also be applied (eg, by heating the mold) to accelerate the polymerization of the elastomeric silicone material. For example, parts A and B of the raw silicone material are mixed together to initiate polymerization of the silicone. For many exemplary silicone materials, this reaction can take 2-6 weeks to fully cure at room temperature. This gives sufficient time for injection molding or other methods to form the mixed silicone material into a non-custom tray of the desired shape, and the process takes the silicone material into the desired shape. After placement, it involves heating the formed material so that it cures more quickly. The step of heating the mixture significantly increases the rate of polymerization of the material. According to an exemplary method, the silicone material formed can be heated at about 375 ° F (about 190.6 ° C), which allows the silicone material to polymerize within seconds. The actual polymerization time depends on the particular silicone product as well as the thickness of the tray being formed. The trays of the present invention can also be cured in other ways, for example the polymerization of two parts silicone is activated by mixing and / or compression.

The dental treatment tray 100 includes the formed tray body 102. The formed tray body 102 includes a buccal-labial anterior side wall 104, a lingual posterior side wall 106, and a bottom wall 108 that spans the buccal-labial side wall 104 and the lingual side wall 106. The bottom wall 108 is adjacent to the buccal-lip side wall 104 so that the buccal-lip side wall 104 extends substantially vertically and laterally from the bottom wall 108. The tongue side wall 106 is located on the opposite side of the bottom wall 108 and extends laterally upward and downward from it. The buccal-lip side wall 104, the tongue side wall 106, and the bottom wall 108 together form a formed tray body 102 with a substantially U-shaped cross section and a nearly horseshoe-shaped curve. Alternative L-shaped trays can include a bottom wall adjacent to the buccal-labial side wall and the buccal-labial side wall.

Buccal-Lip side walls 104 and tongue side walls 106 may include rounded edges 109 to maximize tray comfort compared to trays with sharper or steeper edges. it can. The buccal-lip side wall 104 can include any V-shaped notch 105 formed along its upper surface near the center where the incisors come during use. The V-shaped notch 105 helps the wall 104 extend and bend better with the incisors. Although not shown, such similar cuts or cuts can also be made within the tongue side wall 106.

The size, shape, and curvature of the formed tray body 102 are advantageously selected to make the horseshoe-shaped curvature more or less similar to the curvature of the human dental arch. The U-shaped cross section substantially corresponds to the internal cavity of the tray body 102 and defines the internal cavity. The depth of the internal cavity is selected so that the buccal-labial side wall 104 and the tongue side wall 106 extend above the desired portion of the human tooth, and optionally over the portion of the human gingiva. Buccal-lip side wall 104, tongue side wall 106 due to excellent compatibility, adaptability, flexibility, elastic elongation, and elasticity provided by the elastomeric silicone or silicone-like material that forms the formed tray body 102. , And the ability of the bottom wall 108 to adapt and adapt to human teeth is substantially increased compared to non-custom trays made from non-elastomeric thermoplastic materials.

Due to the non-custom nature of the body 102 (ie, the tray body 102 is not substantially a structure that corresponds to the size and shape of a person's unique dentition), there are a number of different types that accommodate different humans. Comfortably fits size and / or shape teeth. However, since the maxillary arch is generally smaller than the maxillary arch and the maxillary teeth are generally smaller than the maxillary teeth, dentistry of various sizes, which is the size and configuration corresponding to the maxillary and maxillary arches of humans. It is within the scope of the present invention to provide a tray for use. Also to accommodate the variety of dental arches and / or teeth of different people (eg, adults or children, large or average or small mouth, and large or average or small teeth). It is also within the scope of the present invention to provide variable size treatment trays.

The tray body 102 can be injection molded, vacuum formed, cut, and / or punched from a sheet of silicone or silicone-like material, where injection molding involves the outer edge 109 of each wall and the tray of the material. Cutting and / or punching can be done because it can be molded to have a smooth, rounded edge surface rather than the sharply angled surface that is formed when cutting and / or punching from a sheet. Preferably over other methods including. Such smooth edges also contribute to the overall comfort of the tray, in addition to the high comfort provided by the silicone or silicone-like material that forms the body 102.

FIG. 2A shows an alternative non-custom dental treatment tray 200 that includes non-custom anatomical features that allow the tray 200 to more closely adapt to human teeth during use. The body 202 includes a buccal-labial anterior side wall 204, a bottom wall 208, and a lingual side wall 206 connected to the bottom wall 208 opposite to the buccal-labial side wall 204. The illustrated tray 200 is sized and configured for mounting on a human maxillary dental arch. As shown, the tongue side wall 206 can advantageously include a notch 205 that allows the non-custom tray 200 to more easily open or compress at the site of the incisor. This is useful in allowing the tongue side wall 206 of the non-custom tray 200 to be easily adapted to various sizes of dental arches. The bottom wall 204 includes a sharp decrease in the width of the location 210 corresponding to the transition between the molars (ie, premolars and molars) and the anterior teeth (ie, canines and incisors). The bottom wall 208 also advantageously includes two V-shaped recesses 216 for insertion into the recesses between the cusps of the molars (ie, premolars and molars).

FIG. 2A shows a dental bleaching tray 200 in combination with any corresponding outer support tray 250, which is complementary in shape so that the dental bleaching tray 200 can be received in a nested configuration (see FIG. 2B). It is an exploded view. The outer support tray 250 can include the same anatomical features as the tray 200 to provide a tighter fit. The outer support tray 250 favors a handle 252 extending outward from the central part of the buccal-labial anterior wall for easy gripping by the user while mounting the dental bleaching tray 200 over human teeth. Including.

In FIG. 2B, the dental bleaching tray 200 is nested within the outer support tray 250 so as to form the dental tray assembly 255. Handle 252 extends beyond the buccal-lip side wall of tray 200 to facilitate attachment of the outer support tray 250 and to facilitate removal of the outer support tray 250 after mounting the tray 200 on human teeth. There is.

Of course, dental trays within the scope of the present disclosure can advantageously be formed with sufficient self-sustaining integrity so as not to require an outer support tray or other support structure (ie, dentistry). The tray is not so weak that the side walls fall inward). Show a lower Shore A durometer hardness value (eg, about 40 or less), which represents more flexibility to balance with thicker wall thicknesses and provide an overall comfortable fit. , A relatively thick (eg, at least about 0.45 mm) tray can be formed. Relatively thick trays favorably exhibit superior compatibility, elasticity, flexibility, flexibility, and comfort over similarly sized trays formed from, for example, EVA / PP and plasticizer blends.

In one embodiment, a non-custom dental tray containing an elastomeric silicone or silicone-like material can be pre-packaged with a dental treatment composition pre-filled in the tray. To protect the trays and the therapeutic compositions pre-filled in the trays, the dental treatment trays are sealed containers or packages to protect the trays and especially the therapeutic compositions from contamination during storage and before use. Can be packaged inside.

FIG. 3 shows a tray assembly 355 configured to mount on the maxillary arch and a tray assembly 355'configured to mount on the mandibular arch sealed within a protective package 356. The trays 300 and 300'contain the therapeutic composition 354 prefilled in the tray, respectively. Protective package 356 includes a rigid support layer 358 and a removable cover 360. The tray assemblies 355 and 355'can optionally include a removable protective layer (not shown) placed in close proximity to the therapeutic composition 354 for further protection, respectively. When a dental treatment tray device is desired to be used, the removable cover 360 is removed and the tray assemblies 355 and 355'are removed or separated from the support layer 358.

Alternatively, the dental tray disclosed herein can be provided separately from the dental treatment composition that the user later injects into the tray just prior to use. For convenience, a tray assembly containing one or more non-custom dental treatment trays, or treatment trays nested within an outer support tray, together with one or more dental treatment compositions, kit Can be provided at.

Examples of therapeutic compositions include dental bleaching compositions (including, for example, dental bleaching agents such as peroxides), desensitizing compositions (eg, potassium nitrate, other potassium salts, citric acid, citrate). , And / or including desensitizers such as sodium fluoride), remineralization compositions (eg, sodium fluoride, tin fluoride, sodium monofluorophosphate, and / or other fluoride salts, etc. Anti-calculus compositions (including, for example, chlorhexidine, triclosan, and / or anti-tartar agents such as tetracycline), anti-plaque compositions, and anti-tartar compositions (eg, including pyrophosphate). Includes). The therapeutic composition is a viscous, less viscous gel, a more viscous putty, or less adhesive before moistening with saliva or water, but more sticky and adhesive when moistened, substantially. Can contain a solid composition.

For silicone trays pre-filled with an aqueous peroxide containing the dental bleaching composition, the peroxide bleach decomposes prematurely upon contact with the residual platinum and / or tin catalyst present in the silicone material. To prevent this, it is necessary to include a breakable film layer (eg, configured to tear when chewed, bent, and / or flexed) between the prefilled composition and the silicone tray. Can be. Alternatively, the breakable membrane layer can be made water-decomposable, such as being dissolved, decomposed, or dispersed upon contact with water (eg, saliva).

Advantageously, the tray is essentially made of elastomeric silicone or silicone-like material. This is because the inventors have shown that it is a combination of the most beneficial properties, including excellent compatibility, flexibility, flexibility, and elastic elongation, while also exhibiting excellent elasticity. The moisture resistant polymeric material of the tray body preferably consists of silicone or only one or more silicone-like materials, but in some embodiments the material is an elastomeric silicone or a blend of silicone-like materials with other materials. It is also possible to include additional moisture resistant polymeric components to include. Additional materials that can be included in such examples include one or more elastomers (eg, non-silicone-like thermoplastic elastomers), latex, and / or nitriles. Such additional moisture resistant components are preferably about 10% by weight or less, more preferably about 5% or less, more preferably about 3% by weight or less, and most preferably about 1% by weight or less of the tray.

Additional ingredients such as water and / or plasticizers (eg, PEG), colorants, and / or flavors can be added to the composition forming the tray body, but the addition of such materials is generally non-existent. Necessary and relatively unfavorable. Similarly, the addition of such materials is in very small amounts (eg, about 10% by weight or less, more preferably about 5% by weight or less, more preferably about 3% by weight or less, most preferably about 1% by weight or less). is there.

An example of a suitable two-part silicone material is available from Shin-Etsu Silicones, Inc., located in Akron, Ohio, USA. One preferred material is KEG2000-50A / B, the physical characteristics of which are shown in the table below. A variety of other Shin-Etsu Silicones products and silicone materials from other suppliers can also be used.

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A good example of a SEBS material is the SEBS TPE 45A, which is available from a variety of providers. The physical characteristics of SEBS TPE 45A are summarized in the table below. A variety of other SEBS products can also be used.

<tables num="2"><img file="JP2010537745A_D0002.tif" /></tables>

Several suitable VERSAFLEX TPE materials are available from GLS Corporation, located in McHenry, Illinois. Preferred VERSAFLEX materials include VERSAFLEX CL30 and VERSAFLEX CL40, the properties of which are summarized in the table below. You can also use a variety of other VERSAFLEX products from GLS Corporation.

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Examples of other elastomeric silicones and silicone-like materials that can be used are shown in the table below. It should be noted that the silicone-like materials shown below differ in properties from the materials conventionally used in the manufacture of dental treatment trays. For example, while various EVA materials have traditionally been used in the manufacture of dental treatment trays, the EVA materials shown in the table below (ie Ateva 2810A and Evatane 33-400) have elastomeric silicone-like properties (eg, Evatane 33-400). It exhibits (especially elastic elongation, flexibility, and elasticity) and is only superficially similar to the conventional EVA materials conventionally used in the manufacture of dental treatment trays, and its properties are significantly different. For example, it should be noted that each of the materials listed below has elasticity (ie, elastic elongation) of at least about 300 percent, and more specifically between about 450 percent and about 800 percent. As mentioned above, the elastic elongation, elasticity, and flexibility of such materials provide a "feel" that results in much the same performance as elastomeric silicones.

<tables num="4"><img file="JP2010537745A_D0004.tif" /></tables>

When used to deliver a dental treatment composition to a person's teeth, and when it is desirable to maximize compatibility, adaptability, and comfort, the disclosed dental trays generally have a wall thickness. It is less than about 1 mm, preferably in the range of about 0.03 mm to about 1 mm, more preferably in the range of about 0.05 mm to about 0.75 mm, most preferably in the range of about 0.1 mm to about 0.5 mm.

Dental trays with a wall thickness greater than 1 mm are generally less comfortable and fit than the more preferred thinner wall thickness dental trays. This is especially true when using elastomeric materials of the same Shore A hardness. However, unlike the thermoplastic materials used to make traditional dental trays and strips, Shore A hardness elastomeric materials can have high compatibility and adaptability to the user's teeth. , Can be operated more easily (eg, reduction) to form a thicker wall dental tray. Thus, dental trays that are greater than 1 mm thick, preferably less than about 1.5 mm, but still exhibit high compatibility, adaptability, and comfort are within the scope of the present invention.

The durometer hardness / flexibility of elastomeric silicones or other elastomeric materials is advantageously selected to balance flexibility with wall thickness. Within the above preferred wall thickness range (ie, from about 0.03 mm to about 1 mm), Shore A durometer hardness values are preferably in the range of about 90 to about 20. In general, higher durometer values (less flexible) are preferred (eg, flexible) when making trays with thinner walls (eg, to maintain good elasticity and springback properties). For trays with thicker walls (to maintain resilience, high suitability, and comfort), lower durometer values (more flexible) are preferred. For example, a tray with a wall thickness of about 0.25 mm can advantageously have a Shore A durometer hardness value of about 40, whereas a tray with a wall thickness of about 0.1 mm has a Shore A durometer hardness value of about 40. Can be 70. On the other hand, a non-custom tray with a thickness of 1.5 mm can advantageously have a Shore A hardness of about 10.

The elastic elongation of the elastomeric silicone or silicone-like tray materials disclosed herein is the elastic elongation of conventional non-elastomer thermoplastic materials (eg EVA and / or PP) commonly used in forming non-custom trays. Much bigger than. The elastic elongation of the elastomeric silicone or silicone-like material is preferably at least about 50%, more preferably at least about 75%, even more preferably at least about 100%, and most preferably at least about 300%. In one embodiment, the elastic elongation ranges from about 50% to about 2000%, preferably in the range of about 75% to about 1500%, more preferably in the range of about 100% to about 1000%, most preferably about. It ranges from 300% to about 800%.

The dental treatment tray according to the present invention can be produced by injection molding an uncured two-part liquid silicone composition into a mold chamber. In the case of liquid silicone rubber, the two parts have a relatively low viscosity (eg 1500-2000 Pa-s), which is significantly lower than the viscosity of thermoplastic materials conventionally used when molding dental trays. Therefore, the injection pressure at which the material is injected into the mold includes EVA, PCL, PVC, and other materials that have been used for injection molding of dental trays (eg, generally at a pressure of about 20,000 psi, and generally Significantly lower than the injection pressure required when injection molding a dental tray from a commonly used non-elastomer thermoplastic material (which requires the addition of a plasticizer to form a thin wall tray) (eg , About 500 to about 5000 psi, generally about 2000 psi). Due to the significantly lower pressure required to injection mold the tray from silicone compared to conventional thermoplastic materials, the desired structural features, especially very small cross sections (ie less than 0.015 inches or about 0.4 mm). The ability to manufacture trays with is greatly improved. The exemplary tray can be formed with relatively thin walls to achieve an acceptable degree of comfort for the user.

Elastomer silicone or silicone-like dental trays can also be formed with relatively thin walls (which can have the highest comfort), but this is because silicone or silicone-like dental trays of a given thickness It is not necessary as it exhibits much higher comfort than similarly sized dental trays made from non-elastomer thermoplastic materials (eg blends of EVA and PP). Therefore, silicone or silicone-like trays that are equal to or better than existing trays can have significantly thicker wall thickness. In fact, a relatively thick dental tray and its thinness, which can be formed more easily and cheaply by the use of elastomeric silicone or silicone-like materials and can eliminate the need for an outer support tray during installation. Due to its compatibility, flexibility, elastic elongation, elasticity, and its flexible and supple feel, it provides a degree of comfort not found in similar trays made from different materials, more wall thickness. Allows you to choose between thin dental trays.

The dental treatment tray can be worn for a desired period of time. Due to the extremely comfortable fit between the dental treatment tray and the human teeth, the dental treatment tray can be worn for extended periods of time if desired. Dental treatment trays can be worn for as short as minutes or as long as hours. For example, a typical short-term treatment session can last from about 10 minutes to about 30 minutes, and a medium-term treatment session can last from about 30 minutes to about 2 hours, without limitation. Long-term treatment sessions, including custom-made by professionals or night-time treatment during sleep, can last from about 2 hours to about 12 hours.

When used in combination with a sticky therapeutic composition, the disclosed dental treatment trays are used for normal daily routines such as talking, drinking, smoking, coughing, laughing, frowning, and frowning. It can be worn while performing activities or during sleep. The dental treatment tray according to the present invention can be attached to the maxillary dental arch, the mandibular dental arch, or both at the same time.

FIG. 4A shows a person 475 with the dental treatment assembly 455 mounted on the maxillary dental arch. The outer support tray helps in mounting the inner treatment tray over the teeth. FIG. 4B shows the dental treatment tray 400 in place on the maxillary arch and the dental treatment tray 400'in place on the mandibular arch, with both outer support trays removed. There is.

To remove the dental treatment tray after the desired period, the user simply grasps the edge or portion of the tray and pulls it off the teeth. The therapeutic composition that remains adhered to the teeth can be removed by washing or rinsing with water and / or by brushing.

<p> The following can be used to manufacture dental treatment trays according to the invention by injection molding. This is an example of a two-part silicone composition and an elastomeric silicone-like TPE composition. Illustrative formulations and manufacturing conditions are shown using examples, but are not limited thereto. Unless otherwise stated, all percentages are weight percentages.</p><p>[Example 1] A composition for injection molding a silicone dental treatment tray was formed from Shin-Etsu's KEG2000-50A / B 2 part thermosetting silicone material. The viscosity of part A containing the activator / curing agent was about 1700 Pa-s, and the viscosity of part B containing siloxane was about 1600 Pa-s.</p><p> Two parts of the silicone composition were fed from the storage drum through a hose to the static mixing head, where the two parts were mixed together. The mixed silicone material was removed from the static mixer and fed into the screws and barrels of the injection molding machine. The mixed silicone material was injected into a mold (eg, about 375 ° F (about 190.6 ° C)) heated to a temperature at which the material polymerized rapidly. After approximately 30 seconds (ie, 30 seconds ± 10 seconds), the tray was removed from the heated mold after the polymerization was nearly complete. The formed exemplary trays showed excellent compatibility, flexibility, elastic elongation, and flexibility while also being elastic. The molded tray was translucent, with a Shore A durometer hardness of about 50 and an elastic elongation of about 580%. Tray with wall thicknesses of about 0.004 inch (0.10 mm), about 0.006 inch (0.15 mm), about 0.008 inch (0.2 mm), about 0.01 inch (0.25 mm), and about 0.014 inch (0.36 mm) were formed, respectively. The trays are better compatible compared to trays made of materials that do not exhibit the same properties as elastomeric silicones (eg, especially elastic elongation, flexibility, and elasticity) (eg, blends of EVA and PP). It was flexible, elastically stretchable, flexible, and elastic, and was very comfortable when worn on a human dental arch. In addition, the surface of the silicone material tended to adhere (ie, grip) to the tooth surface.</p><p>[Example 2] A composition for injection molding of dental treatment trays was formed from SEBS TPE 45A material. The heated material was fed into the screws and barrels of the injection molding machine. The material was injected into the mold and then cooled. After about 30 seconds (ie, 30 seconds ± 10 seconds), the cooled tray was removed from the mold. An exemplary tray formed from SEBS, like the silicone tray of Example 1, was elastic but exhibited excellent compatibility, flexibility, elastic elongation, and flexibility. The molded tray was translucent, with a Shore A durometer hardness of about 45, elastic elongation of about 800%, and wall thickness of about 0.020 inches (0.5 mm). The tray has better compatibility, flexibility, compared to conventional non-custom trays made from materials that do not exhibit the same properties as elastomeric silicones (eg, especially elastic elongation, flexibility, and elasticity). It was elastically stretchable, flexible, and elastic, and was very comfortable when worn on a human dental arch. In addition, the surface of the SEBS material tended to adhere (ie, grip) to the tooth surface.</p><p>[Example 3] A composition for injection molding of dental treatment trays was formed from VERSAFLEX CL30. The heated TPE material was fed into the screws and barrels of the injection molding machine. The material was injected into the mold. The cooled tray was removed from the mold. The formed exemplary VERSAFLEX CL30 tray, like the silicone tray of Example 1, was elastic but exhibited excellent compatibility, flexibility, elastic elongation, and flexibility. The molded tray was translucent, with a Shore A durometer hardness of about 30, elastic elongation of about 780%, and wall thickness of about 0.020 inches (0.5 mm). Tray has better compatibility, flexibility, elastic elongation, flexibility compared to trays made of materials that do not exhibit the same properties as silicones (eg, especially elastic elongation, flexibility, and elasticity). , And elastic, and very comfortable when worn on a human dental arch. In addition, the surface of the VERSAFLEX CL30 material tended to adhere (ie, grip) to the tooth surface.</p><p>[Example 4] A composition for injection molding of dental treatment trays was formed from VERSAFLEX CL40. The heated TPE material was fed into the screws and barrels of the injection molding machine. The material was injected into the mold. The cooled tray was removed from the mold. The formed exemplary VERSAFLEX CL40 tray, like the silicone tray of Example 1, was elastic but exhibited excellent compatibility, flexibility, elastic elongation, and flexibility. The molded tray was translucent, with a Shore A durometer hardness of about 40, elastic elongation of about 690%, and wall thickness of about 0.020 inches (0.5 mm). Tray has better compatibility, flexibility, elastic elongation, flexibility compared to trays made of materials that do not exhibit the same properties as silicones (eg, especially elastic elongation, flexibility, and elasticity). , And elastic, and very comfortable when worn on a human dental arch. In addition, the surface of the VERSAFLEX CL40 material tended to adhere (ie, grip) to the tooth surface.</p><p>[Examples 5 to 27] Dental treatment trays were formed from the elastomeric silicone or silicone-like materials shown in the table below, respectively. The trays, like the silicone trays of Example 1, were generally elastic, yet exhibited excellent compatibility, flexibility, elastic elongation, and flexibility. The molded tray had a wall thickness of approximately 0.020 inches (0.5 mm) and the Shore A durometer hardness and elasticity (ie,% elongation) were as shown in the table below. Tray has better compatibility, flexibility, elastic elongation, flexibility compared to trays made of materials that do not exhibit the same properties as silicones (eg, especially elastic elongation, flexibility, and elasticity). , And elastic, and very comfortable when worn on a human dental arch.</p><p><tables num="5"><img file="JP2010537745A_D0005.tif" /></tables></p><p> Examples of dental treatment compositions that can be used in combination with the trays disclosed herein are shown below.</p><p>[Example 28] An initial fluid composition suitable for use in producing a substantially solid therapeutic composition was formed by mixing the following components together:</p><p> Ethanol 31.95% 10% water Polyvinylpyrrolidone (MW = 1.3 million) 27% Polyvinylpyrrolidone (MW = about 60,000) 10% Sodium Lauryl Sulfate 0.5% Glycerin 15% Sucralose 25% solution 0.5% Peach flavor 4% Potassium nitrate 0.8% Sodium fluoride 0.25% The final composition was spread over the surface of the dental tray and then dried to form a substantially solid therapeutic composition. The therapeutic composition was initially dry to the touch, but became very sticky when in contact with water or saliva during use. Potassium nitrate has a desensitizing effect on teeth. Sodium fluoride has desensitizing and remineralizing effects. The tray adhered to the tooth tissue with high reliability and showed excellent comfort and adhesion.</p><p>[Example 29] A viscous, viscous dental bleaching composition was prepared by mixing the following ingredients together:</p><p> Water 22.5% EDTA2 sodium 0.1% Carbamide peroxide 18.5% Sucralose 25% solution 0.75% Glycerin 41.6% Carbopol 5.3% Sodium hydroxide 50% solution 2.25% Polyvinylpyrrolidone (MW = 1.3 million) 2% Carboxymethyl cellulose 4% Watermelon flavor 3% Beads of the dental bleaching composition were spread along the buccal-labial side wall of the silicone or silicone-like dental treatment tray according to the invention. Alternatively, the dental bleaching composition is placed on top of a substantially solid adhesive composition pre-filled in a dental treatment tray. The tray adhered to the tooth tissue with high reliability and showed excellent comfort and adhesion.</p><p> Other exemplary dental treatment compositions that can be used in devices according to the invention, and methods for making such compositions, are described in Patent Documents 4, 5, 6, 7, 8, 9, 10, It is disclosed in 11, 12, 13, 14, 15, 16 and 17 filed on July 26, 2006. The above patents and patent applications are incorporated herein by reference to disclose dental treatment compositions and methods for making such compositions.</p><p> The present invention can be practiced in other particular forms without departing from its spiritual or essential characteristics. The embodiments described should be considered in all respects as merely exemplary, not limiting. Therefore, the scope of the present invention is shown not by the above description but by the appended claims. The meaning of the equivalent of the claims and all changes within the scope are included within that scope.</p>