Patent Grant
11723751
The present invention relates to the field of orthodontics. More specifically, the present invention relates to systems and methods for treating mal-alignment of teeth using super-elastic nickel titanium, heat activated nickel titanium coated or uncoated orthodontic wires with composite resins in order to effectuate desired tooth alignment.
Orthodontic treatment is a specialty of dentistry that focuses on the treatment of dental displacement and mal-alignment or misalignment of teeth. Comprehensive orthodontic treatment most commonly involves the use of metal wires that are inserted into orthodontic brackets, which can be made from stainless steel or ceramic materials. The metal wires interact with the brackets to exert continual force on the teeth to gradually urge the teeth toward their intended positions.
More recently, alternatives to conventional orthodontic treatment with traditional braces have become available. For example, systems including a series of preformed appliances/aligners have become commercially available from Align Technology, Inc., San Jose, Calif., under the trade name Invisalign® System. The Invisalign® System is described in numerous patents and patent applications including, for example in U.S. Pat. Nos. 6,450,807, and 5,975,893, as well as on the company's website, which is accessible on the World Wide Web (see, e.g., the url invisalign.com”). The Invisalign® System includes designing and/or fabricating multiple, and sometimes all, of the aligners to be worn by the patient before the aligners are administered to the patient and used to reposition the teeth (e.g., at the outset of treatment). Often, designing and planning a customized treatment for a patient makes use of computer-based 3-dimensional planning/design tools, such as Treat™ software from Align Technology, Inc. The design of the aligners relies on computer modeling of the patient's teeth in a series of planned successive tooth arrangements, and the individual aligners are designed to be worn over the teeth, such that each aligner exerts force on the tooth and elastically repositions the teeth to each of the planned tooth arrangements.
Another orthodontic option is disclosed in U.S. patent application Ser. No. 13/470,681 to Li et al., also assigned to Align Technology. Disclosed is multilayer orthodontic positioning appliance which includes a removable orthodontic tooth positioning appliance having teeth receiving cavities shaped to directly receive at least some of the patient's teeth and apply a resilient positioning force to the patient's teeth. The multilayer appliances can include a hard polymer layer disposed between two soft polymer layers. The orthodontic treatment provides improved material performance, stress relaxation properties and a longer working range.
An alternative orthodontic technology is the LingualWirelign® and Wirelign® technique of Benjamin A. Cassalia, Chalfont, Pa., which provides a system to correct malalignment of teeth using wires alone (that is, without orthodontic brackets) for increased patient comfort and a look without visible “braces” or wires on the facial surface of the patient's teeth. The Wirelign® technique uses straight segments of super-elastic metal wire, usually nickel titanium wire, adhered to surfaces of teeth—usually the lingual surface (i.e. the inside surfaces of teeth, as opposed to the front, facial surfaces)—to align teeth.
In certain cases after the use of currently available orthodontic methods for correcting misaligned teeth, the alignment of teeth is improved but the proper arch form may not be obtained. For example, sometimes as teeth are pulled or pushed into alignment, undesirable tooth movements may occur, resulting in an improper arch form. One reason for certain undesirable tooth movements is that wires typically are bonded to each tooth individually at a fixed distance apart and do not permit the teeth to move closer to one another as they are pushed and/or pulled into alignment. In some cases, mal-alignment of teeth may be minor or of a type that is not easily corrected by current orthodontic procedures alone. And in some cases, continued treatment is desired to maintain or improve proper arch form.
Therefore, there is a need in the art for an orthodontic wire alignment system and method that provides improved arch form and continued alignment of teeth when used alone or after use of other orthodontic techniques, that does so in an aesthetically and cosmetically pleasing way, and is comfortable to the wearer (referred to interchangeably herein as the “patient”). The present invention provides an orthodontic system and method that is a comfortable, cosmetically pleasing means of maintaining or improving optimal arch form when used alone or after use of other orthodontic procedures.
The orthodontic system and method of the invention provide a number of advantages over previously available systems and methods. The placement of the coated wire directly to the surface of the tooth and the placement of flowable bonding material over the wire create a low profile smooth surface system compared to typical orthodontic systems that use brackets with increased profile and distance of the wire from the tooth. The smooth surface of the bonding material used in the invention compared to other brackets system with extended wings or doors minimizes irritation and discomfort to the surrounding oral tissues. The present system and method increase the effectiveness of tooth movement as a result of the close proximity of the wire to the tooth and the potential formation of an orthodontic tube along the entire surface of the tooth. These two factors provide and increase engagement of the tooth surface and therefore enable more effective tooth movement, and especially rotational movement of a tooth.
The present system also provides reduced speech related problems as compared to the prior art. The reduced profile and resulting smooth surface of the material used in the invention is comparable to already used fixed lingual retainer systems which have little to no effect of tongue manipulation and speech related problems. Furthermore, because the orthodontic system of the invention is placed preferably on the lingual surface of the teeth and has low profile characteristics, the orthodontic system of the invention is essentially completely concealed or undetected by observers. A further advantage of the system of the invention is its ease of application. The delivery system of the orthodontic system of the invention is designed for easy clinical application of the coated wire and, as such, also provides improved isolation from contaminants from the oral environment of the mouth.
One object of this invention is to improve the arch form obtained after alignment of the teeth using known orthodontic techniques. By “arch” form as used herein is meant the arch derived by the alveolar process on the jaw containing the dental anatomy of the teeth. The invention also may be used alone to correct mal-alignment of teeth if minimal to moderate tooth movement is required. The design of the arch wire system of the invention allows for the continuation of treatment for misaligned teeth using wires alone (that is, without bulky brackets or fixtures) for increased patient comfort. The wire is preferably affixed to the lingual surface of teeth such that it is not visible when the wearer smiles, thus providing a cosmetic benefit as compared to traditional orthodontic appliances or retainers. Also within the scope of the invention is use of the system of on the facial surface of teeth, albeit such use provides a lesser cosmetic advantage than use on the lingual surface of the teeth. The term “facial” herein is used to mean “non-lingual”, as in the non-lingual surface of a tooth or teeth, and therefore includes “labial” and “buccal”, as in the labial or buccal surface of a tooth or teeth.
A coated orthodontic wire tooth alignment system and method is used alone, after or in conjunction with known orthodontic techniques. A dissolvable coating surrounds an orthodontic wire arch form of super-elastic material such as nickel titanium. The predesigned coated-wire arch form is fixed to the lingual or facial/buccal surface of the teeth to be adjusted by flowable composite bead techniques known in orthodontics. After the composite beads cure and the coating dissolves, an aperture or tube is left around the wire within the composite beads or between the composite and the teeth, allowing the wire to move freely as it returns to its predesigned arch shape, pulling the teeth into alignment with it. Composite brackets with a lateral groove adapted to receive a coated-wire arch form aids precise positioning of the wire on the surface of the teeth. The brackets fit the contours of teeth and are placed and bonded to teeth in the desired positions before application of the arch form. Once in place, the coated wire is bonded directly to the brackets. These brackets may also have a malleable gel like substance embedded in the lateral groove in which a non-coated wire may be inserted and covered with bonding material. The same effect of a tube is formed within the composite bracket when the gel dissolves allowing for the wire to move and align the teeth. The adaption of the wire to the teeth can be direct or assisted with a delivery system that will hold the wire in position for ease of application to minimize contamination associated with the oral environment.
The present invention employs wire of the same dimensions and properties as the nickel titanium wires used in typical orthodontic treatments, that is, super-elastic metal wires including those of nickel titanium or copper nickel titanium, beta titanium, and stainless steel. The wires according to the invention are most preferably super-elastic or heat activated super-elastic wires. The tensile and other physical properties of such wires when placed in the required configuration to the teeth impart a force onto the teeth that allow tooth movement to occur within the buccal cavity until the point where the desired visual effect is achieved. Preferably according to the invention, wire arch forms are pre-formed in various lengths and gauges to accommodate the needs of a variety of different patients. Though they are called “arch forms”, the actual shape of the pre-formed wire arch forms may not be “arch-shaped” depending on their intended application—for example, a full-mouth lingual arch form would be mushroom shaped. The term “arch form” herein is used expansively to include any pre-shaped length of wire intended or used to correct a patient's mal-aligned teeth. The pre-shaped wire corrects improper arch form in a patient's teeth by being placed and bonded to the patient's teeth as shown in
In one embodiment of the invention, the wire is coated with a dissolvable coating, preferably a gelatin-like substance such as the gelatin coating used in medicinal liquid gel tablets or a coating having a lubricating effect such as TiO2 (titanium dioxide). In a preferred embodiment, a coating particularly useful in the invention comprises titanium dioxide, starch, ethanol and lacquer.
Other dissolvable media that do not hinder the elastic properties of the wire and are safe for the patient may be used.
Coatings operable within the scope of the invention include coating currently available in the dental industry, such as titanium dioxide, polyamide, cellulose derivative, or homopolymer/copolymer of poly(ethylene oxide). Other coating operable within the scope of the invention include substances commonly used in the food and the pharmaceutical industry with materials that render the substance to be delivered either more easily or pleasantly administered or more palatable to the consumer. Such coatings include, but are not limited to: alginates; biopolymers (such as xanthan gum and scleroglucan); carrageenans; galactomannans (such as locust bean gum and guar gum); pectins; native starches (such as products sold under the trademarks AmyloGel@, CreamGel™, DryGel™, Gel™); thinned starches (such as Cargill Set™ and Cargill DrySet@); stabilized starches (such as Cargill Tex®, CreamTex@, PolarTex@ and StabiTex@); Pregelatinized starches including roll-dried starches (such as Cargill Tex-Instant™, Gellnstant™, StabiTex-Instant®, and PolarTex-Instant@) and cold-water swelling starches such as (HiForm@ and HiForm ATM); specialty starches (such as AccuCoat@, AccuFlo™, AraSet™, BatterCrisp®, Clean Set®, DeliTex™, EmCap@, EmTex@, EZ Fill™, and Salioca@); food additives including cellulose; microcristalline cellulose; potato; modified wheat starch; talc; finely ground sugar; icing sugar or powder mix, made of icing sugar, starch, fat and flavor; beet or cane sugar; other sweet sugar solution; fruit juice; honey; caramel; malt; fat; oil; chocolate; cocoa powder; other artificial flavoring; hydrocolloid concentrated solutions (for the purpose of ‘sealing’ the surface to prevent fat migration, harden the surface, offer a smooth surface to the final glazing application); alcohol-based solutions of resins, essentially shellac resin (for the purpose of ‘finishing’ the surface to prevent water migration and reducing friction) and others. A particularly useful reference is found on the World Wide Web at http://www.colorcon.com/products-formulation/all-products, the contents of which are incorporated herein by reference. Other ingredients such as vitamins can be incorporated into the coatings of the invention so as to render additional health benefits to the patient during the time period that the patient undergoes treatment with the apparatus and system of the invention.
The coating surrounding the wire increases the diameter of the wire to specific dimensions depending on the size and cross-sectional shape of the wire it coats. In one embodiment of the invention, the coating is a noticeably and distinctively different color than the core wire so that complete dissolution of the coating may be easily confirmed visually.
The coated wire arch form is placed directly on the lingual or facial (labial or buccal) surface of the teeth. Activation of the wire is created via a pulling force with floss, engagement jigs as shown in
The dental composites operable within the scope of the invention are any dental composite resins typically used in the dental industry, such as synthetic resins which are used in dentistry as restorative material or adhesives. Examples of composite resins most commonly include bisphenol A glycidyl methacrylate (bis-GMA) and other dimethacrylate monomers, such as triethylene glycol dimethacrylate (TEGMA), urethane dimethacrylate (UDMA), hex anediol dimethacrylate (HDDMA), and a filler material such as silica. Dimethylglyoxime is also commonly added to achieve certain physical properties such as flowability. Further tailoring of physical properties is achieved by formulating unique concentrations and combinations of each constituent.
According to the method of the invention, a “bead” of flowable composite material is applied over the coated wire on each tooth to be aligned. As used herein, the term composite “bead” indicates an application of composite material that is sufficient to attach the wire to the tooth surface. As used herein, the term “bond” or “attach” as referring to the composite material used in the system of the invention means that the composite material is fixedly connected for some period of time by either chemical or physical means to the surface of the tooth.
The composites are bonded herein onto the teeth by either light, chemical activation or heat activation as commonly performed in the dental art. In order to bond the composite to a tooth, the tooth must be kept substantially dry during placement or the resin will likely fail to adhere to the tooth. Composites are placed while still in a soft, dough-like, or flowable state but when exposed to light of a certain blue wavelength (typically 470 nm, with traces of ultra-violet light]), they polymerize and harden onto the tooth. Once properly attached, the composite is comfortable, aesthetically pleasing, strong and durable, and usually lasts throughout the duration of the treatment without the need for reapplication. The composite is typically applied to the tooth by using a syringe. A primer may be used to allow the composite resin to easily infiltrate the surface enamel matrix to bond more strongly to the tooth. A photo-initiator is often added to the composite in order to aid and increase the speed of the curing process of the composite. Prior to applying the composite, the enamel of the teeth may be prepared by etching with 30%-50% phosphoric acid and rinsing thoroughly with water and drying with air only.
Within 1 to 2 hours after being bonded to the patient's teeth (and after the bonding material has cured), the coating surrounding the wire dissolves completely, thus exposing the underlying wire and leaving an aperture or tube within the cured bonding material through which the wire may move freely. By allowing free movement of the now-exposed wire through the aperture(s) in the bonding material, the bonding composite “beads” and apertures operate as a tube similar to a “frictionless bracket system” housing the wire and allowing the now-uncoated wire to express its super-elastic properties and pre-designed arch form, pulling and/or pushing the mal-aligned teeth into conformity with it as it returns to its preformed shape.
Without the apertures or tubes left around the wire by the dissolved coating, the wire would not be free to slide back and forth within the composite beads as it returns to its preformed shape; thus restricted, the force exerted by the wire returning to its preformed shape also would push teeth apart and create space between the teeth or other undesirable tooth movements or not move the teeth at all. Also to be noted is that the composite beads are not limited to any particular shape or geometric configuration, and are limited in size only as to the practical consideration of comfort of the patient within the buccal cavity.
As the teeth align and the wire slides within the tubes formed in the composite beads, the ends of the wire arch form are pushed farther and farther beyond the terminal beads. The ends of the wire arch form may be covered with a bead of composite for comfort or, alternatively, may be pre-formed with smooth ends. Once the wire is activated by being bonded to the teeth or templates, stops of composite, crimpable stops or other stops may be formed or preformed on the arch form ends or between the teeth to prevent the wire arch form from sliding too far and dislodging. As used herein, a “stop” means an element or component positioned on the wire after placement onto the teeth or an element or component that is incorporated into or onto the wire during the fabrication of the wire not encompassed by the flowable composite during wire placement and has a larger dimension than the aperture or tube created by the coating dissolving from the wire. Coated wire arch forms of the system are preferably pre-formed and pre-shaped in various lengths and gauges (sizes), preferably with smooth ends or terminal beads for patient comfort and to act as stops. The stops are created or pre-formed on the ends or midpoint of the wire arch form so as to prevent the wire from slipping out of the composite bonding covering or beads when the teeth align. Though preferably the stops are placed on the ends or midpoint of the wire arch, the stops may be positioned at any location along the wire arch. The coated arch forms can also be custom shaped for any individual and their arch forms.
The wire arch form may be affixed to one or more teeth or templates at the center of the arch or the longitudinal mid-point of the wire, preferably using a tiny bead of composite or incorporated in the arch wire, thus keeping the mid-point of the wire arch form fixed in place (i.e., preventing the wire arch form from sliding out of place) while permitting sliding within the composite beads on either side of the mid-point as the teeth are pushed and pulled into alignment. A tiny bead of composite is one way the midpoint of the wire arch form can be kept in place, but other ways may be devised. The wire is left in place in the mouth until it has returned completely or substantially to its original shape or the teeth are aligned. This typically occurs in 4 to 6 weeks, but may require either less or more time depending on the needs of each patient. The wire arch form is removed by removing the stops or by cutting the wire into segments. If further alignment is desired after the initial placement and activation, the wire can be re-bonded and activated on an individual tooth or be replaced by another coated wire.
In one embodiment, a coated wire arch form comprising a substantially round wire core having a circular cross-section and a dissolvable coating of specific and even thickness is used. In another embodiment, a coated wire arch form comprising a square or rectangular wire core having a coating of specific and even thickness is used. As used herein, the term “rectangular” as referring to the cross section of the wire of the invention shall also encompass embodiments having a square cross section. The preferred diameter of nickel titanium wire core is generally 0.012 inches for round wire core and 0.016×0.022 inches or 0.022×0.016 (at its widest diameter) for rectangular wire core. The coating surrounding the wire core increases the wire's diameter as compared to the uncoated wire. The preferable diameter of the coated wire is enough to create a dimension large enough for the wire to slide in the formed tubes after the coating is dissolved but still staying as thin as possible to allow for the wire to engage the perimeter of the formed tube within the composite bonding surrounding the wire thereby creating the necessary pressure or activation of the wire with a maximum of 0.018 inches for the round wire and 0.018×0.025 inches or 0.025×0.018 for the rectangular wire. In all embodiments, a specific outer dimension of the coated wire may be achieved depending on the choice of wire and the thickness of the coating. It is preferred that the outer dimension of the coated wire be only slightly larger than the diameter of the core wire so that engagement of the core wire in the formed tube be adequate for desired tooth movement yet not interfere with core wire movement. Therefore, it is preferred that the thickness of the coating on the wire is in the range of 0.001 inches to 0.006 inches, such that the total thickness of the wire together with the coating is in the range of 0.013 inches to 0.018 inches.
Where a wire arch of rectangular dimension is used, it is preferred that the rectangular wire has a height that is greater than the depth of the wire as the wire is positioned along the teeth, thus keeping within the objective of the invention in providing an orthodontic appliance with a low in profile within the mouth that is comfortable to the patient, as illustrated in
In addition the wire, may also incorporate loops 150 or any other shape modification that may assist in tooth movement, as illustrated in
According to another embodiment of the invention, composite brackets with a lateral or horizontal groove are provided that are adapted to receive the coated-wire arch form, which are used as an alternative to the composite beads to assist with precise positioning of the wire on the surface of the teeth. The composite brackets preferably are made to fit the contours of the lingual or facial surface of teeth and are placed and bonded to the teeth in the desired positions before application of the coated wire arch form. The bonding or attachment to the teeth is accomplished in the same manner as the composite beads as described hereinabove. Once in place, the coated wire arch form is bonded directly to the bracket. The brackets' grooves may be specifically shaped to effect a pre-programmed torque adjustment (correcting mal-alignment of a tooth's cant or rotation along the labial/lingual or buccal/lingual axis) when used in the system. Preferably, in this torque-adjusting embodiment, bracket grooves have one of a variety of specific rectangular cross-sectional shapes corresponding to the desired torque adjustment, adapted to be used with a pre-shaped arch form of wire with a rectangular cross-section. These brackets may also be used in the continuation of treatment if further activations or increased engagement of the orthodontic wire is necessary to align the teeth. At subsequent visits, any tooth which requires further activation can be reactivated by removing the existing bonded covering of the wire. The direct application of bonding material locks the now non-coated wire and inhibits wire movement due to lack of tube formation. The open end of the bracket can be placed over the wire against the tooth while the wire is reactivated by an external force (floss or other engagement module). The extensions of the brackets may be coated with a thin layer of composite/bonding material or dental adhesive to help secure the bracket in position. Though a composite covering is preferred and is the logical choice based on industry practice, the covering can be made of an alternate functioning material. Flowable bonding material then covers the existing bracket except in the areas of the lateral openings extending over the surface area of the tooth securing the bracket in position. The opening within the bracket acts as an orthodontic tube and allows for the expression of the arch wire to align the teeth. Additionally, an embodiment may contain a groove or slot coated by a metal that is then secured by a composite covering.
In addition to this embodiment, the grooves of the bracket can be prefilled with a dissolvable gel or malleable substance, as illustrated in
The gels operable in this embodiment of the invention comprise agar, agar agar, carrageenan iota, carrageenan kappa, gellan gum, lecithin powder or gel, pectin powder or gel, sodium alginate, xanthan gum, as well as other compounds known in the art and interchangeable therewith. As used herein, these and other substances that are operable within the scope of the invention are referred to herein as the “gel”.
In addition the dissolvable gel may be applied directly to the tooth surface via syringe or other type of applicator while the now non-coated wire is positioned against the tooth (see
In addition to the direct placement of the wire, the system of invention may also be placed into the mouth with a delivery system for ease of engagement and in order to minimize contamination from the oral environment. This system is comprised of a custom tray that is specifically fitted to the teeth and mouth of each patient, in which the coated wire is housed and positioned for proper placement, as illustrated in
In this respect, before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of processes, steps, or construction, or to the arrangements of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments and of being practiced and carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein are for the purpose of description and should not be regarded as limiting.
As such, those skilled in the art will appreciate that the conception, upon which this disclosure is based, may readily be utilized as a basis for the designing of other structures, methods, and systems for carrying out the several purposes of the present invention. It is important, therefore, that the claims be regarded as including such equivalent constructions insofar as they do not depart from the spirit and scope of the present invention.
It should be understood that the above described figures are not intended to limit the scope of the present invention in any way and are intended to illustrate the embodiments of the invention.
Referring now to
The wire core 30, is preferably nickel titanium, but wire made of any metal or other material with similar super-elastic properties, including copper NiTi (copper-zinc-aluminum-nickel, copper-aluminum-nickel), Sentalloy®, Neo Sentalloy® and Bioforce® wires or any other super-elastic wires or wires with ion-implantation process, may be used.
The round wire core 30 has a preferred diameter of 0.012 inches, but a round core having a diameter from 0.010 inches to 0.017 inches is operable. The cross-section of the rectangular wire core 30 of the invention can be in the range of 0.012 inches to 0.022 inches. The rectangular core 30 has a preferred diameter of 0.012×0.018 inches, but a rectangular core having a diameter from 0.012×0.018 inches to 0.016×0.022 inches is also operable within the scope of the invention.
Referring now to
Referring now to
Each composite bracket 300 is placed where desired and bonded to the teeth, before application of the wire arch form, using known orthodontic bonding techniques, such that the grooves in each bracket align to form a guide for proper placement of the arch form. The grooves 55 are adapted to hold a coated orthodontic wire arch form 100 in place by being of sufficient depth and diameter and sufficiently conforming shape that the arch form 100 is movably captured with enough friction fit to resist slipping or falling but not so tightly that the arch form cannot be easily adjusted during placement. The optimal dimensions of the grooves 55 are 0.018 inches deep and 0.018 inches in diameter measured at the surface of the bracket as shown in
Demonstrated in
Over the course of a period of time (in the range of 4 weeks to 8 weeks, depending on the patient), the now-uncoated wire arch form 30 returns to its preformed shape, pulling teeth into alignment with it. Referring now to
Referring now to
The coated wire arch form is placed in position and movably held there by friction fit with the brackets' grooves or by force generated against the wire via floss or other form of engagement jig (
Referring now to
One of ordinary skill understands that a “tooth” can be natural or artificial (such as a crown or an implant, or filled with composite material, etc.).
It is to be understood that the present invention is not limited to the embodiments described above or as shown in the attached figures, but encompasses any and all embodiments within the spirit of the invention.
This Continuation application claims the benefit under 35 U.S.C. § 120 of application Ser. No. 16/411,315 filed on May 14, 2019 which, in turn, claims the benefit under 35 U.S.C. § 120 of application Ser. No. 14/244,985 (now U.S. Pat. No. 10,342,640) filed on Apr. 4, 2014, all of which are entitled Orthodontic Wire Alignment System and Method, which in turn claims the benefit under 35 U.S.C. § 119(e) of Provisional Application Ser. No. 61/808,953, filed on Apr. 5, 2013, entitled Coated Orthodontic Wire Alignment System and Method.
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| Number | Date | Country | |
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| Number | Date | Country | |
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| Parent | 16411315 | May 2019 | US |
| Child | 17380588 | US | |
| Parent | 14244985 | Apr 2014 | US |
| Child | 16411315 | US |
