AU6187701A - Relined dental device and method - Google Patents

Description

'A

P/00/011 Regulation 3.2

AUSTRALIA

Patents Act 1990

ORIGINAL

COMPLETE SPECIFICATION STANDARD PATENT .0 0 .0 0 0000 0 .:00.

Invention Title: Relined dental device and method The following statement is a full description of this invention, including the best method of performing it known to us: Freehills Carter Smith Beadle Melbourne\003880803 Printed 17 August 2001 (15:12) page 2 Freehills Carter Smith Beadle Melbourne\003880803 Printed 17 August 2001 (15:12) page 2 003880380 1 RELINED DENTAL DEVICE AND METHOD TECHNICAL FIELD OF THE INVENTION This invention relates generally to dental devices, and more particularly to a relined dental device and a method.

BACKGROUND OF THE INVENTION Many dental devices include a deformable material for forming a mold of some or all of a user's teeth. It is often desirable to form a mold that properly fits the user's teeth to improve the performance of the associated dental device.

Dental devices that do not properly fit the user's teeth may not adequately serve 10 the purposes for which the devices are constructed.

As dental devices become increasingly complex to satisfy a variety of treatment, comfort, safety, and other requirements, users or clinical professionals may wish to form a mold that more optimally fits the user's teeth. A known technique for forming a mold of a user's teeth includes inserting a heat-deformable 15 mouthpiece into the user's mouth, pressing the user's teeth into the mouthpiece, and removing the mouthpiece from the user's mouth after the mouthpiece has cooled. Such techniques may not provide a proper fit, however, due to the tendency of many deformable materials to contract during cooling, thereby expanding the impressions made by the user's teeth. In addition, this technique 20 must often be repeated numerous times before even a marginally adequate fit can be achieved.

Deformable materials used in connection with such techniques may also cool more quickly and display less thermoplasticity at certain temperatures than the user or clinical professional might desire, thereby limiting the time in which the user or clini9calo professional may manipulate the deformable material to form a mold of the user's teeth. Furthermore, mouthpieces fitted using such techniques may be less safe for the suer due to the increased tendency of the user's teeth to move with respect to the mouthpiece that does not properly fit the user's teeth.

003880380 2 Moreover, many deformable mouthpiece materials may display insufficient dimensional stability during cooling, bonding properties, hardness, or biocompatibility to function properly in a variety of contexts. In addition, such materials may be difficult or impossible to introduce into the mouth of a user to properly customize an existing mouthpiece, limiting the efficiency, economic availability, and effectiveness of techniques associated with these materials.

SUMMARY OF THE INVENTION The invention provides a dental device, comprising: an arch adapted to receive one or more of a user's teeth; i 10 a deformable material coupled to the arch, the deformable material comprising a first aliphatic polyester; and a mask coupled to the arch.

The invention further provides a method for forming a dental device for use in a user's mouth, comprising the steps of: 15 coupling a deformable material to an arch, the arch adapted to receive one or more of the user's teeth, the deformable material comprising a first aliphatic polyester; coupling a mask to the arch; and wherein the use is selected from the group consisting of: preventing injury; and treating a breathing disorder.

003880380 3 An advantage of the present invention is the ability to provide a relined dental device and method to more optimally fit the user's teeth. Improved fit may be important in connection with dental devices designed to reduce or eliminate trauma injuries or breathing problems such as sleep apnoea. The deformable material of the present invention may provide desirable hardness, biocompatibility, dimensional stability during cooling, thermoplasticity, and bonding properties for a variety of contexts. Furthermore, because the improved deformable material may be delivered to a selected region of the dental device, the present invention significantly improves the ability of users or clinical professionals to customise dental devices in an efficient, economical, and effective manner Other technical advantages are readily apparent to one skilled in the art from the following figures, descriptions and claims.

BRIEF DESCRIPTION OF THE DRAWINGS For a more complete understanding of the present invention and for further Z 15 features and advantages thereof, reference is now made to the following description taken in conjunction with the accompanying drawings, in which: •ooeo "0 Figures 1 a and lb illustrate dental devices having an improved deformable material; o~o Figures 2a and 2b illustrate a method for relining a dental device using an ~20 improved deformable material to customise the dental device; and Figures 3a and 3b illustrate masks having an improved deformable material.

DETAILED DESCRIPTION OF THE INVENTION FIGURE la illustrates a dental device 10 that includes an upper arch 12 adapted to receive one or more of a user's upper teeth and a lower arch 14 adapted to receive one or more of the user's lower teeth. When dental device 10 is in use, upper arch 12, lower arch 14, or both upper arch 12 and lower arch 14 are inserted into the user's mouth.

Although device 10 may include upper arch 12, lower arch 14, or both upper arch 12 and lower arch 14, device 10 is discussed below as including only upper arch 12. It should be understood that the following discussion applies equally to a device 10 that includes lower arch 14 instead of, or in addition to, upper arch 12.

Upper arch 12 includes a tray 18 formed from any material suitable for dental uses, for example, methyl methacrylate or a polycarbonate resin thermoplastic such as that sold under the Registered Trademark LEXAN. Such materials are known to those familiar with dental devices, and other suitable materials may be used to form tray 18 without departing from the intended scope of the present invention. For example, tray 18 may also be formed from one or more other thermoplastic polymers, such as one or more of the polycaprolactone polymers or other aliphatic polyesters described in U.S. Patent Nos. 5,112,225 and 25 4,784,123, both of which are herein incorporated by reference, as well as in literature distributed by Union Carbide Corporation. One or more polycaprolactone polymers may be combined in some manner with one or more other polymers or other suitable materials to form a tray 18 having any number of characteristics, properties, or uses.

The present invention contemplates using one or more polycaprolactone polymers or other suitable aliphatic

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polyesters to replace or combine with methyl methacrylate for any suitable dental application.

Tray 18 is adapted to receive a deformable material in which molds of one or more of the user's upper teeth may be formed. Deformable material 20 may be formed from any suitable material, for example, a polyvinyl acetate such as the ethylene-vinyl acetate copolymer resin sold under the Registered Trademark ELVAX. In one embodiment, deformable material 20 includes at least one polycaprolactone polymer or other aliphatic polyester discussed above. The polycaprolactone polymer may have the formula: O O 0o 0 II II (2) H[0(CH),C]q-R-O[C(CH 2 5 0],H where R is an aliphatic hydrocarbon and n may range from 15 approximately 300 to approximately 650. The present invention contemplates polycaprolactone polymers having other suitable formulas.

Deformable material 20 may include any suitable polycaprolactone polymer or other aliphatic polyester, for 20 example, and not by way of limitation, the TONE P-700, TONE P-767, or TONE P-787 polycaprolactone polymers manufactured by Union Carbide Corporation, taken singly or in any combination. A suitable light cured material, another polymer, or any other suitable material, such as a filler, coloring agent, stabilizer, antioxidant, or antimicrobial agent, may be used to replace or combine with one or more of the polycaprolactone polymers in forming a deformable material 20 having any number of characteristics, properties, or uses.

The TONE polycaprolactone polymers are described in U.S. Patent Nos. 5,112,225 and 4,784, 123, and in literature distributed by Union Carbide Corporation, as homopolymers, block copolymers, graft copolymers, or other polymers that contain epsilon-caprolactone. Polymerization may be initiated using one or more diols, for example, and not by way of limitation, ethylene glycol; diethylene glycol; neopentyl glycol; butane diol; hexane diol; or any other suitable diol. At least one of the diols may have the formula: HO-R-OH (3) «o where R is an aliphatic hydrocarbon.

S* In one embodiment, deformable material 20 includes approximately thirty (30) parts by volume TONE P-700 and sixty (60) parts by volume TONE P-767, together with approximately ten (10) parts by volume of one or more other polymers, depending on the application. The present :invention contemplates forming an impression material such as deformable material 20 using any suitable mixture or combination of one or more polycaprolactone polymers, other polymers, and other appropriate materials, compounds, or compositions. As discussed more fully below, the mold formed using deformable material 20 may be relined to more optimally fit the user's teeth, which may be particularly advantageous if deformable material is not formed from one or more polycaprolactone polymers.

Deformable material 20 may begin as extruded pellets, beads, or rods of uniform, similar, or differing size, or in other suitable form. Deformable material 20 is heated in a microwave oven, in water or other non-solvent neutral II liquid, or in any other suitable manner to between approximately 140 degrees Fahrenheit and approximately 180 degrees Fahrenheit to place deformable material 20 in its deformable state. Deformable material 20 may be kept in a deformable state until the pellets, beads, or rods congeal, coalesce, or otherwise combine to form a deformable mass capable of assuming a multitude of configurations and shapes. Deformable material 20 may be placed in a deformable state before, during, or after deformable material 20 is delivered to upper arch 12 or coupled to tray 18. The present invention contemplates deformable material 20 mixing, reacting, or otherwise combining with the material used to form tray 18 while deformable material is in a liquid or other deformable state.

In one embodiment, upper arch 12, including tray 18 .and deformable material 20, is inserted into the user's mouth separately from or together with lower arch 14. The user bites down or otherwise presses one or more of the user's teeth into deformable material 20 in order to form a mold of one or more of the user's teeth. Deformable material 20 is then allowed to cool and harden or otherwise take a more permanent shape. These steps may be repeated as many times as necessary or desired to form a mold of one or more of the user's teeth using deformable material 25 In another embodiment, tray 18 is inserted into the user's mouth to receive on or more of the user's teeth, and deformable material 20 is delivered to tray 18 or selected regions of tray 18 to form a mold of the user's teeth.

Deformable material 20 may be delivered to tray 18 while in a liquid, melted, or any other deformable state using a syringe, hypodermic needle, hot glue gun, or other suitable delivery device.

8 An important technical advantage of the present invention is that deformable material 20 may cool more slowly and may display thermoplastic properties at lower temperatures than materials such as the ethylene-vinyl acetate copolymer resin sold under the Registered Trademark ELVAX. This provides the user or clinical professional with more time to properly conform deformable material to the user's teeth. In addition, deformable material may display increased dimensional stability during the cooling process, relative to ELVAX,, which may reduce or eliminate fitting problems that might otherwise develop due to the tendency of materials such as ELVAX to contract during cooling, thereby expanding the impressions made by the user's teeth. Furthermore, deformable material 20 may S 15 be more easily, efficiently, and economically applied than S. other deformable materials using an appropriate delivery device.

Upper arch 12 may remain inserted in the user's mouth or may be removed from the user's mouth before, during, or after deformable material 20 cools. Deformable material may be formed into a mold of one or more of the user's teeth in the user's home, in the office of a clinical professional, or in any other suitable location. The present invention contemplates any suitable technique for 25 forming a mold of one or more of the user's teeth using one or more polycaprolactone polymers. Furthermore, upper arch 12 may be coupled to lower arch 14, a mask, or other apparatus in some suitable manner to form a device suitable for preventing trauma injuries or treating breathing problems such as sleep apnea.

Alternatively, as shown in FIGURE lb, upper arch 12, lower arch 14, or both upper arch 12 and lower arch 14 may themselves be formed from a deformable material suitable 9 for dental uses, for example, a deformable material that includes any of the polycaprolactone polymers or other aliphatic polyesters discussed above. A suitable light cured material, another polymer, or any other suitable material may be used to replace or combine with one or more of the polycaprolactone polymers in forming the deformable material, depending on the application. Regardless of the manner in which the mold of the user's teeth is formed using deformable material 20, the mold may be relined to more optimally fit the user's teeth using one or more polycaprolactone polymers or any other suitable material in the manner discussed below.

*o FIGURES 2a and 2b illustrate a method for relining a dental device 11 using one or more of the polycaprolactone 15 polymers or other aliphatic polyesters discussed above with reference to FIGURES la and lb. Although polycaprolactone polymers or other aliphatic polyesters are discussed, the present invention contemplates any suitable material to *n replace or combine with a polycaprolactone polymer or other 20 aliphatic polyester to reline dental device 11. For example, a light cured material, another polymer such as ELVAX, or any other suitable material may be used to replace or combine with one or more of the polycaprolactone polymers in relining dental device 11.

Referring to FIGURE 2a, one or more of the user's upper or lower teeth, represented generally by tooth 16, have been pressed or otherwise inserted into deformable material 20 to form a first mold 28 of tooth 16 that resembles the outward surface 17 of tooth 16. Although upper arch 12 is discussed as including first mold 28, the present invention contemplates device 11 having lower arch 14 instead of, or in addition to, upper arch 12. Tooth 16 is shown in its natural state within the user's gum 24.

Deformable material 20 has been allowed to cool and harden or otherwise take a more permanent shape.

Due to the tendency of deformable material 20 to contract during cooling, for example, if deformable material 20 is not formed from one or more polycaprolactone polymers, the impression made by the user's teeth has expanded to form a first mold 28 that does not optimally fit the user's teeth. In the alternative, first mold 28 may have been improperly formed, such that first mold 28 does not optimally fit the user's teeth. First offset indicates the amount by which first mold 28 is separated from outward surface 17 when tooth 16 is positioned within upper arch 12. The present invention further contemplates forming first mold 28 using the upper arch 12 illustrated 15 in FIGURE lb or any other mold of one or more of the user's teeth.

A deformable layer or material 32 is introduced into the region between outward surface 17 and first mold 28 from any suitable source or delivery device 40, for 4 o example, and not by way of limitation, a syringe, hypodermic needle, hot glue gun, or other suitable delivery device. Deformable material 32 may be placed in a deformable state before, during, or after deformable material 32 is placed in or becomes contained within delivery device 40. In one embodiment, deformable material 32 is placed in delivery device 40, placed in a liquid, melted, or other deformable state, and delivered to a selected region of upper arch 12 to reline first mold 28.

Deformable material 32 couples to first mold 28 and wholly or partially fills the region between first mold 28 and the outward surface 17 of tooth 16. As a result, first offset is reduced or eliminated, yielding a relined or customized dental device 11 that more optimally fits one or 11 more of the user's teeth. Deformable material 32 may be delivered to upper arch 12 and may couple.to or otherwise combine with first mold 28 while deformable material 32 is in a liquid, melted, or other deformable state.

In one embodiment, deformable material 32 includes one or more of the polycaprolactone polymers or other aliphatic polyesters discussed above. Deformable material 32 may also include other polymers or any other suitable mixture, compound, composition, or material, depending on the application. The present invention contemplates using a polycaprolactone polymer or other aliphatic polyester in any suitable dental or other application for which delivery eo of a deformable material to a selected region using a syringe, hypodermic needle, hot glue gun, or other suitable 15 delivery device is necessary or desirable. As discussed *oe above, deformable material 32 may cool and harden or otherwise take a more permanent shape relatively slowly and display increased thermoplasticity during cooling, compared to materials such as ELVAX. This may provide the user or

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20 clinical professional with additional time to properly conform deformable material .32 to the shape of the user's teeth.

In one embodiment, although deformable material 32 wholly or partially surrounds tooth 16 and couples to first mold 28 while deformable material 32 is in a liquid or melted state, the user experiences little or no discomfort when deformable material 32 is introduced. This is due to a variety of factors, taken separately or in combination.

First, since deformable material 32 includes one or more polycaprolactone polymers or other polymers, alone or together with other suitable materials, deformable material 32 may transfer relatively little heat to tooth 16 and the tissues of the user's mouth. Second, since deformable material 32 is delivered in a relatively thin layer, the volume of material transferring heat to tooth 16 and the tissues of the user's mouth is relatively small.

Therefore, the user's mouth may absorb the heat transferred from deformable material 32 with little or no discomfort.

Third, the user's teeth and the tissues of the user's mouth are generally well-adapted to exposure to hot substances, for example, hot food and liquids. The present invention contemplates other factors that may also contribute to the user experiencing little or no discomfort when deformable material 32 is introduced into device 11.

As shown in FIGURE 2b, deformable material 32 couples to first mold 28 and forms a second mold 36 of tooth 16.

1 'In one embodiment, deformable material 32 mixes, reacts, or 15 otherwise combines with deformable material 21 to form second mold 36. A second offset 34 indicates the thickness of the space, if any, between second mold 36 and the outward surface 17 of tooth 16. Although deformable material 32 may have a tendency to contract as it cools, 20 second offset 34 is smaller than first offset 30. As a result, second mold 36 conforms to the shape of tooth 16 more optimally than did first mold 28. This may be due, at least in part, to the dimensional stability displayed by polycaprolactone polymers as deformable material 32 cools, which reduces the contraction of deformable material 32 during the cooling process.

As indicated by the dashed lines 39, upper arch 12 or lower arch 14 may remain inserted in the user's mouth or may be removed from the user's mouth before, during, or after deformable material 32 cool's or otherwise hardens to form second mold 36. Once second mold 36 is formed, upper arch 12 may be repeatedly removed and reinserted into the user's mouth as appropriate for the treatment or other use 13 for which device 11 was constructed. Furthermore, upper arch 12 may be coupled to lower arch 14, a mask, or other apparatus in some suitable manner to form a device suitable for preventing trauma injuries or treating breathing problems such as sleep apnea.

Important technical advantages of the present invention include providing a relined dental device 11 that is customizable by the user or a clinical professional to more optimally fit the user's teeth. Improved fit may be important in connection with dental devices designed to reduce or eliminate trauma injuries or breathing problems such as obstructive sleep apnea or snoring. Further, the present invention provides a dental device 11 that may be more optimally fitted to the user's teeth without removing 15 device 11 from the user's mouth, providing improved S" efficiency. Additional advantages may be provided according to the particular deformable material 32 used.

FIGURE 3a illustrates a deformable material 50 that has been conformed to the shape of at least a portion of a o 20 user's face to form a mask 52. In one embodiment, deformable material 50 includes one or more of the polycaprolactone polymers discussed above, and may also include other polycaprolactone or other polymers or any other suitable material. Deformable material 50 is placed in its deformable state, delivered to a selected region of the user's face using a syringe, hypodermic needle, hot glue gun, or other suitable delivery device, and spread over at least a portion of the surface of the user's face so as to conform to the shape of the user's face over one or more contact regions. Straws or other breathing tubes may be inserted into the nostrils of the user beforehand, so that breathing channels 54 are formed in mask 52 when deformable material 50 cools or otherwise hardens to form 4 14 mask 52. Because deformable material 50 includes one or more polycaprolactone polymers, deformable material 50 may cool relatively slowly, have increased thermoplasticity during cooling, and display increased dimensional stability during cooling, compared to materials such as LEXAN or

ELVAX.

Mask 52 may be coupled to strap attachment 58 and strap 56 to allow the user to secure mask 52 about the user's head. A continuous positive air pressure (CPAP) device may be attached to mask 52 in some suitable manner, for example, using a deformable material that includes one or more polycaprolactone polymers or any other suitable material, to deliver a gas to the user's nose. Mask 52 may be coupled to any dental or other suitable device designed oe 15 to prevent trauma injuries or treat breathing problems such as sleep apnea. The present invention contemplates using mask 52 in any suitable manner, whether or not mask 52 is coupled to a dental or other device.

As shown in FIGURE 3b, deformable material 50 may. be used to customize an existing mask 60 for a particular user. Deformable material 50 is placed in a deformable state and coupled to mask 60 around at least a portion of the perimeter of mask 60 so as to conform to the shape of the user's face. Deformable material 50 may be delivered 25 using a syringe, hypodermic needle, hot glue gun, or other suitable delivery device. In one embodiment, polyvinyl siloxane may replace or combine with deformable material to customize mask 52 or mask 60 for a particular user. For example, polyvinyl siloxane may be formed around at least a portion of the perimeter of mask 52 or mask 60, as the case may be, so as to conform to the shape of the user's face. The polyvinyl siloxane may be coupled to deformable material 50 after deformable material 50 has been used to customize mask 60. The present invention contemplates forming or customizing a mask in any suitable manner using one or more poiycaprolactone polymers.

Although the present invention has been described above in connection with several embodiments, it should be understood that a plethora of changes, substitutions, variations, alterations, transformations, and modifications may be suggested to one skilled in the art, and it is intended that the present invention encompass such changes, substitutions, variations, alterations, transformations, and modifications as fall within the spirit and scope of the appended claims.

It will be understood that the term "comprises" (or its grammatical variants) as used in this specification is equivalent to the term "includes" and should not be taken as excluding the presence of other elements or features.

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