WO2014097155A1

WO2014097155A1 - Formable mouth tray for teeth whitening

Info

Publication number: WO2014097155A1
Application number: PCT/IB2013/061058
Authority: WO
Inventors: Gregory Russ GODDARD; Tyler G. KLOSTER; Lester Ronald GREER, Jr.; Scott E. HALL; Lane Evan KLEPPEN
Original assignee: Koninklijke Philips N.V.
Priority date: 2012-12-18
Filing date: 2013-12-18
Publication date: 2014-06-26

Abstract

A whitening tray (10) includes a shell member (11) of soft, pliable material, such as silicon, the shell member having a front section (12) and a rear section (14), separated by a distance to define a tray to receive whitening gel and the teeth of a user. A thin, formable member is located within the shell member, providing formability for the tray.

Description

Formable Mouth Tray For Teeth Whitening

FIELD OF THE INVENTION

This invention relates generally to appliances for teeth whitening, and more particularly concerns a teeth-whitening tray for whitening gel. BACKGROUND OF THE INVENTION

Whitening appliances, including mouthpieces, trays and strips, are in general well known. Teeth-whitening strips are applied directly to the teeth, but are problematic in terms of positioning and removal, since the strips are often difficult to position evenly on the teeth, and further, require users to position their hands inside their mouth. Whitening trays are also used, but they do not maintain the geometric configuration for the teeth of the user, i.e. they tend to rebound to an original shape. Other trays utilize a boil-and-bite arrangement, which requires the user to place the tray/mouthpiece in boiling water and then position the appliance in the mouth, where it is conformed to the geometry of the user's teeth, and hardens with that shape. This appliance is typically quite cumbersome, and the resulting mouthpiece is bulky and is typically uncomfortable in the mouth.

Hence, it is desirable to have a tray/mouthpiece which can be readily formed to the individual dentition and which remains in that position for the teeth-whitening process.

SUMMARY OF THE INVENTION

The aforementioned objective is addressed by a device according to claim 1, a tray according to claim 2, and a whitening system according to claim 3. Preferred

embodiments are disclosed in the dependent claims.

In a first aspect, an embodiment of the invention relates to a device for whitening the teeth, said device comprising the following components:

- A shell member of pliable material that can be brought into the form of a tray having a front section and a rear section, separated by a distance to form a tray to contain whitening gel and adapted to receive front teeth of a user. A formable thin member positioned within the shell member, such that when the tray is formed around the user's teeth, the tray retains its form when removed from the teeth.

The above device may have or assume different three-dimensional shapes as it is made from flexible materials. One of these shapes is particularly a flat shape that may for example be assumed immediately after manufacturing, during transportation, during storage and/or during sale of the device. This flat shape can then be transformed into the operative shape of a tray by the user, said tray being individually adapted to the user's teeth.

The formable thin member is preferably completely embedded in the shell member, though in some embodiments of the invention the formable thin member may at least partially be exposed at the surface of the device, too.

According to a second aspect, an embodiment of the invention relates to a tray for whitening the teeth that comprises: a shell member of pliable material, having a front section and a rear section, separated by a distance to form a tray to contain whitening gel and adapted to receive front teeth of a user; and a formable, thin (preferably metal) member positioned within the shell member to define the tray, such that when the tray is formed around the user's teeth, the tray retains its form when removed from the teeth.

Also, a teeth whitening system using a tray comprises: a shell member of pliable material, having a front section and a rear section, separated by a distance to form a tray to contain whitening gel and adapted to receive front teeth of a user; a formable member positioned within the shell member to define the tray, such that when the tray is formed around the user's teeth, the tray retains its form when removed from the teeth; and one part of a two part whitening gel present in the tray provided to the user; wherein the other part of the whitening gel is mixed with the one part in the tray by the user.

The above device, tray, and whitening system are based on the same concept, i.e. the usage of a shell member of pliable material within which a formable thin member is positioned to provide form stability. Explanations provided for one of these elements are therefore analogously valid for the other elements, too.

In the following, various preferred embodiments of the invention are described that can be realized in combination with the device, the tray, and the teeth whitening system.

The formable thin member may comprise any material that is capable to confer sufficient rigidity for maintaining a shape (e.g. that of a tray or mouthpiece) when removed from the mouth of the user. Suitable materials may particularly comprise metals or plastics, for example aluminum, stainless steel, titanium, copper, brass, wax, fluoropolymers, impregnated fiber mesh or the like.

The formable thin member may preferably be a metal foil or a mesh piece or a combination thereof. The rigidity of such an element can readily be adapted by designing it with an appropriate thickness, wherein even local variations of thickness/rigidity are possible. As an example, the metal foil or mesh piece may typically have a thickness in the range of about 0.1 mm to about 0.6 mm. Moreover, the rigidity of a mesh piece can be adjusted by selecting the sizes of its apertures appropriately.

The shell member may particularly comprise an elastomeric material, such as a thermoplastic elastomer (TPE), particularly a thermoplastic polyurethane (TPU). The thickness of this elastomeric material in the front section and the rear section may typically be within the range of about 0.2 mm to about 0.5 mm.

To increase flexibility of the device and to allow for a relative movement of shell member and formable member, gas or air bubbles may be incorporated into the device, preferably adjacent to the formable member.

In another embodiment, recesses or pockets may be provided on the interior side of the front section, adjacent the front surface of the teeth. Such recesses or pockets can be used for holding gel during application of the device.

When being adapted to the teeth of a user, the whitening tray may typically assume a "J" shape in cross-section or a "U" shape in cross-section. Additionally or alternatively, the tray may preferably cover approximately the eight or ten upper or lower front teeth of the user's mouth.

The whitening tray may be designed to be disposable or to be reusable. Its front and rear sections may comprise or consist of different materials, with different properties.

In a preferred embodiment, the formable thin member is stiffer in a vertical direction (i.e. perpendicular to the row of teeth when located in the mouth of a user) than in a horizontal direction across the teeth. In this case the tray has highest flexibility in a direction where adaptation is needed most.

In order to facilitate usage of the whitening tray, its first section may have indicia indicating the desired portion of drops of gel in the tray. Additionally or alternatively, it may have indicia for a fill line for the gel in the tray or indicia for the center of the tray for proper placement of the tray. Whitening gel may optionally be provided in the tray during manufacturing. In a preferred embodiment, one part of a two part whitening gel may be present in the tray as provided to the user, wherein the other part of the whitening gel is mixed with the one part in the tray by the user.

In another embodiment of the invention, the formable thin member and/or the shell member may comprise at least one cut-out. The basic shape of the shell member and/or of the formable thin member will typically be compact and convex, for example substantially rectangular (when the member is spread out to a flat shape). The cut-outs remove material from the interior of such a basic shape, particularly excess material that would be squeezed and wrinkle up when the device is adapted to the teeth of a user. The cutouts thus help to ease adaptation of the device and to stabilize its final shape by reducing restoring forces.

In another embodiment, a strip of a soft material and/or a strip of an adhesive material and/or a strip of a soft and adhesive material is disposed along at least one edge of the shell member. Arranging a soft material at the edges makes the application of the whitening system more comfortable. Provision of an adhesive that reversibly attaches to gingival tissue helps to seal the interior of the tray from the user's mouth.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other aspects of the invention will be apparent from and elucidated with reference to the embodiments described hereinafter.

In the drawings:

Figure 1 is an isometric view of the teeth-whitening tray disclosed.

Figure 2 is a cross-sectional diagram of the teeth-whitening tray having a "J-shape" configuration.

Figure 3 is a cross-sectional diagram of the teeth-whitening tray having a

"U-shape" configuration.

Figure 4 is a cutaway view of a teeth whitening tray with a metal mesh member.

Figure 5 is an isometric view of a whitening tray with indicia markings relative to gel placement or fill.

Figure 6 is an isometric view of a whitening tray with an indicia marking indicating the center of the tray.

Figure 7 is an exploded view of a device for whitening the teeth according to a further embodiment of the invention; Figure 8 is an isometric view of the device of Figure 7 in its assembled state; Figure 9 is an isometric view of a device for whitening the teeth which comprises cut-outs.

Like reference numbers or numbers differing by integer multiples of 100 refer in the Figures to identical or similar components.

DETAILED DESCRIPTION OF EMBODIMENTS

Figure 1 shows an isometric view of a teeth-whitening tray, generally at 10. Tray 10 is curved, covering typically at least the eight upper or lower front teeth of the mouth, and preferably ten teeth. Tray 10 is adapted to hold conventional teeth-whitening gel, with the tray being used to accomplish a teeth-whitening function. Tray 10 includes a front portion 12 which is positioned adjacent the front surfaces of the teeth, and a rear portion 14 which is positioned adjacent the rear surfaces of the teeth. The two ends of tray 10 are shown at 15 and 18. The ends of the tray are typically, but not necessarily, angled from the free edges 18, 20 of the front and rear portions to the opposing rounded edge 19 thereof. Typically, the front and rear portions are separated by a small distance, sufficient to accommodate the teeth of the user as well as an effective amount of teeth-whitening gel. Typically, this distance will be approximately 5-10 mm. There could be trays of different sizes for the upper and lower teeth, although a single size tray can be used for both.

The rear portion 14 will typically be shorter than the front portion 12, such that in cross-section, such as shown in Figure 2, the arrangement has the appearance of a "J". In another embodiment, however, the rear portion is approximately the same height as the front portion, such that in cross-section the appearance is like a "U", as shown in Figure 3. In the "J" configuration, the rear portion typically covers approximately one-eighth of the vertical surface of the teeth, but could cover up to one-fourth and even one-half of the teeth. In the "U" configuration, it could extend all or nearly all the way up the rear surface of the teeth, such as shown in Figure 3.

The material comprising the tray provides the distinct advantage of the present tray. The tray comprises a soft plastic member or members 22, which form the interior and exterior surface portions 24 and 26 of the tray. In the embodiment shown, the outer member is elastomer, such as silicon, which is soft, flexible, safe for use, comfortable for the user and easy to manufacture. Positioned interiorly of the outer elastomer member is an inner metal layer 28, which can be either foil or mesh, or a combination of foil and mesh. This layer 28 must be thin, stiff and formable. In the present embodiment, the thickness of the metal member is between 0.1 mm to 0.6 mm, with 0.3 mm being preferred. The elastomer members on either side of the inner metal layer can vary in thickness, from relatively thin, such as 0.1 mm, to 1 mm and even greater. The elastomer member on the front side could be a different material than the rear side, sealed together along a joining edge. The two sections could have different properties. The interior side could be quite soft, for comfort.

The advantage of the above-described arrangement is that the mouthpiece is formable, and after being formed, remains in the formed position, i.e. the user positions the tray in his/her mouth and with their fingers forms the tray to their teeth geometry. The metal member and the flexible outer member permits such formation; the formed configuration is retained by the stiff yet formable metal member. The mesh or foil arrangement of the metal member, having the specified thickness, accounts for the configuration being maintained. The metal member could be various materials, such as brass, aluminum, steel or copper, for example. The metal member could be non-isotropic, for instance, with the member being stiffer in the vertical direction (up/down on the teeth) than in the horizontal direction (across the teeth). The formed tray is removed from the teeth and a whitening gel is deposited in the tray. The tray is then positioned back onto the teeth for the amount of required treatment time. When the treatment is completed, the tray is removed and rinsed and is then ready for use by the patient at another time, retaining its particular previously obtained shape. The tray could also be single use (disposable). The gel could also be provided on the tray for the user, or the gel could be provided in two parts, with one part being provided in a formable tray to the user and the second part being added by the user prior to use of the tray. Such a tray would be disposable.

The exterior elastomeric member must be soft, flexible and comfortable, as it makes contact with the user's teeth and tissue. It must be easy to manufacture in thin sections, as indicated above. The inner member must be thin, stiff, formable and retain its formed shape relative to particular dentition. The resulting combination is comfortable yet effective as a reliable teeth- whitening tray.

The tray could also have indicia for use. Referring to Figure 5, there could be indicia 44 on tray 46 indicating where drops of gel should be placed or alternatively a full line, shown at 47. The indicia would also include a mark 48 indicating the center of the tray for proper placement of the tray in the mouth, shown in Figure 6.

There are various ways to manufacture the above-described tray. In one, the two outer elastomeric, e.g. silicon, layers are pressure-molded into thin (0.2 mm-0.5 mm) generic tray portions. The metal, preferably aluminum, foil or mesh is then formed and stamped into the same generic tray shape. The metal foil is then sandwiched by the two silicon layers and placed in a compression tool which fuses the silicon layers together with the intermediate metal foil/mesh. Referring to Figure 3, with a mesh 28, this results in recesses or pockets 40 in those areas where there is no metal. This provides areas for gel to collect. In another method, the metal/foil mesh is insert-molded into the silicon by an injection molding tool.

During usage of a conventional teeth whitening device, some or all of the bleaching composition can dissolve away into the user's saliva and/or be transferred to adjacent oral tissues, potentially irritating soft oral tissues. Even if a user successfully maintains a conventional bleaching mouthpiece in its proper position during the

recommended bleaching period, the bleaching gel often diffuses into the saliva, potentially causing a poor taste in the user's mouth and possibly discomfort to soft oral and throat tissues. The dilution of the bleaching composition by the saliva also reduces efficacy of the bleaching operation. The tendency of the bleaching gel to diffuse into the user's mouth can be accelerated through even minimal shifts of the mouthpiece/strip over the user's teeth, with each shift potentially causing bleaching gel that remains adhered to the user's teeth to be exposed to saliva in the user's mouth.

The aforementioned issues are largely avoided by using a tray of the kind described above that can individually be fitted to a user's teeth. Moreover, additional strips can be arranged along the edges of a whitening device, particularly strips of a soft and/or adhesive material, for example a hydrogel boundary. Together with the unique shape provided by the whitening devices of the invention, this ensures ease of use and soft tissue protection.

The embodiments shown in Figures 7-9 rely upon the use of laminant fabrication techniques. Two layers of TPU or TPE are laminated with a mesh or foil between them. Along the perimeter of the gingival facing surface, a layer of adhesive is applied. The shape of the part is preferably "notched" in such a way that it may be fabricated flat then folded, without wrinkles, around the user's dentition.

Figure 7 shows an exploded view of one embodiment of such a device 110 for whitening the teeth as it is provided immediately after manufacturing. Figure 8 shows the device in its assembled state. In this state, the device 110 has a flat form that is optimal for transportation and storage.

The whitening device 110 comprises, from bottom to top, the following sequence of layers and materials: An outer layer 101.

A formable thin member 128, here realized by a mesh. Instead of a mesh, a foil could be used, too. The mesh 128 (or a foil) should confer sufficient rigidity to maintain shape when removed from the mouth. The resistivity of the formable member should however preferably not be greater than about 6 N to form to the shape of the user's dentition. The mesh 128 (or a foil) can for example be made from metal or plastics, such as aluminum, stainless steel, titanium, copper, brass, wax, fluoropolymers, or impregnated fiber mesh.

An inner layer 102 that may be made from the same material as the outer layer 101 or from a different material. Suitable materials for these layers comprise sheets of thermoplastic like TPU or TPE. The outer layer 101 and the inner layer 102 are laminated on either side of the mesh 128. Together they constitute a "shell member" 111.

A first strip 131 of adhesive and a second strip 132 of adhesive that are arranged along the long edges of the device 110. These strips may particularly be made from a soft material and are arranged at the interior surfaces of the device that during usage come into contact with the gingival tissue.

A crosshatched pattern of lamination may be applied that creates pockets of air-resin to allow the mesh 128 or foil to stretch or compress as needed to match the shape of the dentition. Alternately, the thermoplastic layers 101, 102 may be sufficiently elastomeric to allow this same motion by their elasticity.

During usage, the device 110 is placed in the mouth and shaped over the teeth with care to form to interdental spaces as well as overall jaw. Once a tray is sufficiently formed it can be removed for loading with compounds of interest. It is then placed back in the user's mouth as part of the treatment regimen.

Figure 9 shows another device 210 for teeth whitening that has substantially the same basic structure as the device 110 of Figures 7 and 8. In contrast to the latter, the device 210 comprises however cut-outs 229, 230 in the mesh 228 and a cut-out 230 in the shell member 211. The cut-outs allow for origami-like folding of the mouthpiece without wrinkling. One or more cut-outs can be used to fulfill this purpose, depending on the level of curvature needed in the final mouthpiece. These cut-outs also allow for additional engineered expansion joints.

Again, pieces 231, 232, 233 of adhesive provide sealing points at the lingual side. These seals prevent whitening compound or other treatment material from escaping into the user's mouth and saliva from infiltrating to dilute the treatment material, reducing its efficacy.

Although a preferred embodiment of the invention has been disclosed here for the purposes of illustration, it should be understood that various changes, modifications and substitutions may be incorporated in the embodiment without departing from the spirit of the invention, which is defined by the claims which follow.

While the invention has been illustrated and described in detail in the drawings and foregoing description, such illustration and description are to be considered illustrative or exemplary and not restrictive; the invention is not limited to the disclosed embodiments. Other variations to the disclosed embodiments can be understood and effected by those skilled in the art in practicing the claimed invention, from a study of the drawings, the disclosure, and the appended claims. In the claims, the word "comprising" does not exclude other elements or steps, and the indefinite article "a" or "an" does not exclude a plurality. A single processor or other unit may fulfill the functions of several items recited in the claims. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage. Any reference signs in the claims should not be construed as limiting the scope.

Claims

CLAIMS:

1. A device (10, 110, 210) for whitening the teeth, comprising: a shell member (11, 111, 211) of pliable material that can be brought into the form of a tray (10) having a front section (12) and a rear section (14), separated by a distance to form a tray to contain whitening gel and adapted to receive front teeth of a user; and

a formable thin member (28, 128, 228) positioned within the shell member, such that when the tray is formed around the user's teeth, the tray retains its form when removed from the teeth.

2. A tray (10) for whitening the teeth, comprising:

a shell member (11) of pliable material, having a front section (12) and a rear section (14), separated by a distance to form a tray to contain whitening gel and adapted to receive front teeth of a user; and

a formable thin member (28) positioned within the shell member to define the tray, such that when the tray is formed around the user's teeth, the tray retains its form when removed from the teeth.

3. A teeth whitening system using a tray, comprising:

a shell member (11) of pliable material, having a front section (12) and a rear section (14), separated by a distance to form a tray to contain whitening gel and adapted to receive front teeth of a user;

a formable member (28) positioned within the shell member to define the tray, such that when the tray is formed around the user's teeth, the tray retains its form when removed from the teeth; and

one part of a two part whitening gel present in the tray as provided to the user; wherein the other part of the whitening gel is mixed with the one part in the tray by the user.

4. The device (10, 110, 210) of claim 1, the tray (10) of claim 2, or the teeth whitening system of claim 3,

wherein the formable thin member (28, 128, 228) comprises a metal or plastics.

5. The device (10, 110, 210) of claim 1, the tray (10) of claim 2, or the teeth whitening system of claim 3,

wherein the shell member (11, 111, 211) comprises an elastomeric material.

6. The device (10, 110, 210), the tray (10), or the teeth whitening system of claim 5,

wherein the thickness of the elastomeric material of each section is within the range of 0.2-0.5 mm.

7. The claim 1, the tray (10) of claim 2, or the teeth whitening system of claim 3,

wherein the formable thin member (28, 128, 228) is a metal foil or a mesh piece, or a combination thereof, said metal foil or mesh piece preferably having a thickness in the range of 0.1 mm to 0.6 mm.

8. The claim 1, the tray (10) of claim 2, or the teeth whitening system of claim 3, including recesses or pockets (40) for holding gel, on the interior side of the front section (12), adjacent the front surface of the teeth.

9. The claim 1, the tray (10) of claim 2, or the teeth whitening system of claim 3, wherein the tray has a "J" shape or a "U" shape in cross-section.

10. The device (10, 110, 210) of claim 1, the tray (10) of claim 2, or the teeth whitening system of claim 3,

wherein the front and rear sections are different materials, with different properties.

11. The device (10, 110, 210) of claim 1, the tray (10) of claim 2, or the teeth whitening system of claim 3,,

wherein the formable thin member (28, 128, 228) is stiffer in a vertical direction than in a horizontal direction across the teeth.

12. The device (10, 110, 210) of claim 1, the tray (10) of claim 2, or the teeth whitening system of claim 3, wherein the front section has indicia (44) indicating the desired portion of drops of gel in the tray or the fill line (47) for the gel in the tray or the center of the tray (48) for proper placement of the tray.

13. The device (10, 110, 210) of claim 1, the tray (10) of claim 2, or the teeth whitening system of claim 3,

wherein whitening gel is provided in the tray for the user.

14. The device (210) of claim 1, the tray of claim 2, or the teeth whitening system of claim 3,

wherein the formable thin member (228) and/or the shell member (211) comprises at least one cut-out (229, 230).

15. The device (210) of claim 1, the tray of claim 2, or the teeth whitening system of claim 3,

wherein a strip (131, 132, 231, 232, 233) of soft and/or adhesive material is disposed along at least one edge of the shell member (111, 211).