WO2013009339A1

WO2013009339A1 - Method and apparatus for non-metallic braided orthodontic wire and method of manufacturing of same

Info

Publication number: WO2013009339A1
Application number: PCT/US2011/061585
Authority: WO
Inventors: Thomas F. BRAUN
Original assignee: Overjet Llc
Priority date: 2011-07-12
Filing date: 2011-11-21
Publication date: 2013-01-17
Also published as: WO2013009339A9; CN204092224U

Abstract

The present invention is an orthodontic wire comprising a plurality of strands of generally non-metallic, elastic material, and methods for manufacturing same. The strands are layered in helical parallel, or braided, co-axially about a core. The core can be hollow, or can comprise an additional strand. Each of the wire strands is selected to form an optimal combination based on material composition and as determined by a goal established for the end-use of the wire during a particular procedure. The wire can be sheathed or unsheathed in a bio-suitable composition; and, can incorporate spectrum selected materials. An optimal wire composition matrix, or chart, can be established based on the conditions under which the wire will be subject.

Description

UNITED STATES PROVISIONAL PATENT APPLICATION FOR

METHOD AND APPARATUS FOR NON-METALLIC BRAIDED ORTHODONTIC WIRE AND METHOD OF MANUFACTURING SAME

INVENTORS:

Thomas F. BRAUN

200 Lakeside Dr.

Fairfield, CT 06824

Prepared by:

Lackenbach Siegel, LLP

Lackenbach Siegel Building

One Chase Road

Scarsdale, New York 10583

Tel: (914) 723-4300

Fax: (914) 723-4301

METHOD AND APPARATUS FOR NON-METALLIC BRAIDED ORTHODONTIC WIRE AND METHOD OF MANUFACTURING OF SAME

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to an orthodontic wire comprising a plurality of strands that are generally flexible. More specifically, the present invention relates to an orthodontic wire comprising a plurality of strands that are generally flexible and may be selected from a variety of strands of a particular composition for the optimal construction of an arch wire for a specific use. This invention further relates to methods for manufacturing orthodontic wires in a standard shape or in a shape customized to the specification of the user, and more particularly, to a shape and composition which will produce desired force vectors to move teeth in a specific manner customized to a particular patient or class of patients.

2. Description of the Related Art

The present invention and related art find their basis in the field of orthodontics which is a specialty within dentistry. Generally, orthodontics deals with the study and treatment of improper bites, which may be a result of tooth irregularity, disproportionate jaw relationships, or both. Orthodontics is formally defined by the American Association of Orthodontics as:

The area of dentistry concerned with the supervision, guidance and correction of the growing and mature dentofacial structures, including those conditions that require movement of teeth or correction of malrelationships between and among teeth and facial bones by the application of forces and/or the stimulation and redirection of the jaws within the craniofacial complex.

More specifically, the related art involves the use of a metallic or single purpose wire attached to a series of brackets to accomplish an orthodontic procedure. These types of procedures involve bonding or otherwise securing of the brackets to corresponding teeth which are then moved into a corresponding arc relationship by force applied by the wire running therethrough over a period of time.

What is not appreciated by the prior art is the flexibility of composition required in arch wires based upon the needs of the end-user patient.

Accordingly, there is a need for an improved orthodontic wire that is comprised of a plurality of strands that are co-axially situated relative to each other; and, where the composition of the strands is optimized for a given end-use. Further, there is a need for a method of determining the end wire composition based upon the use of strands selected to accommodate a particular end-use.

Furthermore, the typical orthodontic method to straighten or align teeth of a patient is to bond brackets onto the teeth and, in succession, insert a series of wires with increasing stiffness and a variety of twists or bends into the bracket slots. These brackets are generally manufactured in any one of a series of standard prescriptions. These prescriptions describe the dimensions and orientation of a generally rectangular recess or slot on the front of the bracket which engages the wire. The shape of all wires is generally in a progressive series of shapes and stiffness which gradually move the teeth into the desired position with forces and velocity of movement, which will move teeth in an optimal manner without causing injury or damage to the teeth or supporting oral structures. Over the last several years, there has been increasing use of three dimensional digital data describing the positions of the teeth and jaws and the shape and design of orthodontic wire, brackets, and various treatment appliances. This data has also been used to diagnose malocclusion and project tooth movement in the future from the use of various types of orthodontic appliances. There are number of companies which provide scanning machines and software to the orthodontic market which dentists use to produce digital data. They include Cadent, a division of Align Technologies, and 3 Shape. Also, numerous machines in the industrial market can be used to digitally scan dental impressions to produce digital data for this purpose.

Wires have been generally manufactured in the following manner:

1) An orthodontist or skilled lab technician working under an orthodontists' direction, will bend wires by hand using hand instruments from straight lengths of wire or industry standard arch blanks in the approximate shape of an average dental arch. Bends will be placed to create the desired forces on the teeth to produce the desired tooth movement. The wire can be heat treated or strain hardened to affect elasticity or stiffness, so the desired forces are applied to the teeth when the wire is attached to the dental brackets.

2) Digital data produced by a variety of means directs a wire bending machine or robot, to bend the wire into the desired shape. The wire can be heat treated or strain hardened to affect elasticity or stiffness, so the desired forces are applied to the teeth when the wire is attached to the dental brackets.

3) Non metallic wires made from fiber reinforced composite material can be shaped into the desired shape to move teeth in the desired manner when attached to the dental brackets. These wires can be shaped by a hand process or an automated digitally controlled machine process.

4) Wires can be produced from various polymer materials by a difficult extrusion through a die or by cutting from a larger block of material. The shapes and forces produced when these wires are attached to dental brackets in the mouth can be used to move teeth.

Manufacture of such wires and prototypes according to these known methods are slow and often produce incorrect results, thereby requiring multiple attempts. Such processes are costly and inefficient. Accordingly, there is a need for an improved method of manufacturing orthodontic wires and/or prototypes using a rapid prototyping machine to directly produce the orthodontic wires, or molds to produce orthodontic wires, preferably right there in the practitioner's office. ASPECTS AND SUMMARY OF THE INVENTION

An aspect of the present invention is to provide a flexible arch wire, for use in orthodontic procedures, which will be easily adaptable to the prevailing conditions in the user environment.

Another aspect of the present invention is to provide a selection matrix for selecting the optimal combination of strands to form an orthodontic wire for use in a given situation.

The present invention relates to an orthodontic wire comprising a plurality of strands of generally non-metallic, elastic material; but, can be formed of metallic/non-metallic composites. The strands are layered in helical parallel, or braided, co-axially about a core. The core can be hollow, or can comprise an additional strand. Each of the wire strands is selected to form an optimal combination based on material composition and as determined by a goal established for the end-use of the wire during a particular procedure. Further, the wire can be bio-compatible. The wire can be sheathed or unsheathed; and, can incorporate radio-opaque materials that will cause the wire to be "visible" during a radiographic scan. Additionally, the wire comprises retaining means for retaining a wire in place by use of a bonding agent such as Bis-GMA (composite resin formula). The agent can be used to secure the wire to a supporting molar or other specified tooth as needed. An optimal wire composition matrix or chart can be established based on the conditions under which the wire will be subject. According to an embodiment of the present invention, there is provided an orthodontic wire comprising a plurality of strands of an elastic material. The plurality of strands are layered in helical parallel or braided co-axially about a core. The core can be hollow; or, in an alternative embodiment, can comprise an additional strand. Each of the wire strands is selected to form an optimal combination based on material composition and as determined by a goal established for a use of the wire.

The strands of the orthodontic wire are composed of materials selected from a group further comprising: a fiber re-enforced composite; a nickel titanium compound (NiTi); a polymer sheath over a NiTi core; a curable resin; stainless steel; beta-titanium; chrome cobalt; or, other metallic alloy with suitable mechanical or biocompatible properties; polymer; monomer; or, other biocompatible non-metallic material with suitable mechanical properties; or, biocompatible strands, such as those commercially available from BioMers Products, LLC of Bothell, Washington.

The cross-section of each of the plurality of strands can be circular, rectangular, wedged, or of whatever shape is optimal for a particular task or procedure for which the wire will be used. The use of certain cross-sections will allow the facilitation of coupling of the strands to provide an overall more smoothly profiled wire. The wire, itself, can be sheathed or unsheathed depending on the needs of the end-user. Generally, the sheathing would be of a non-abrasive material so as to reduce irritation to the mouth or surrounding tissues of the end- user, and reduce friction between the wire and orthodontic brackets. The strands of the wire can each be of the same non-metallic, elastic material; or, a blend can be employed wherein the wire combines both metallic and non-metallic strands in combination. Both the metallic and non-metallic classes can further comprise a blend of different compositions within the type class. Additionally, the wire can incorporate radio-opaque materials that will cause the wire to be "visible" during a radiographic scan. These types of scans may be necessary in the event that an end-user (i.e., a patient) aspirates or swallows a portion of the wire or subordinate device.

In an alternative embodiment of the present invention, there is presented a method for providing an orthodontic wire, for use in an orthodontic procedure, wherein the method comprises several steps. These steps include the determination of the wire end use and the properties required for that use. The end use is compared to a matrix of available wire that can be used for a particular purpose. If the particular purpose dictates the use of a wire that is not in inventory, then the system user can build an appropriate wire by selecting one or more strands to be joined. For instance, the strands could be joined in a helical pai-allel co-axially about a core, before cutting the fonned wire to a selected length.

Optionally, a molar terminal endcap can be placed on each end of the cut wire before joining an endcap so as to fix its position on the wire. If the endcap is used, the method further comprises the step of securing each of the molar terminal endcaps to a respective molar by using a resin to effect bond therewith. Additionally, each one of the one or more strands is selected from a set of strands of varied material composition. An optimal mix of the strands is determined based upon conditions established for each of a plurality of orthodontic procedures. If a plurality of strands is used, then at least one of the strands could be radio-opaque as requested by the end-user. The conditions, in turn, are selected from a group of relevant conditions. These can include: the length of time of use of the wire; the tension required to optimally support the orthodontic procedure; the elasticity required to optimally support the procedure; and, the sensitivity of the patient ("end-user") with respect to end-use of the wire. Or, for simply aesthetic purposes, colored, transparent, or translucent strands can be utilized.

In support of the strand selection process, an optimal wire composition matrix or chart can be established based on the conditions under which the wire will be subject, and its intended function.

The present invention describes a reliable and repeatable method of manufacturing an orthodontic wire directly in a desired shape and stiffness without the need to manipulate a stock or semi custom pre manufactured wire to meet a specific prescription. The present invention preferably uses digital data derived from this or other similar systems to direct a rapid prototyping machine (i.e., a machine used for the automatic construction of physical objects using additive manufacturing technology) to produce a wire or series of wires directly (i.e., in the practitioner's office). Such wires can be used without the need for additional steps to alter their shape or physical properties, although such steps can be done if desired. The material produced can be made of a variety of biocompatible plastics, metal, or various combinations of materials used by rapid prototyping machines with suitable mechanical properties. Alternatively, a mold or series of molds can be produced which can be filled with a desired polymer or other suitable materiel to produce a wire or series of wires. Such wires can be used without the need for additional steps to alter their shape or physical properties, although such steps can be done if desired. In such embodiments, the digital data used is derived from intra-oral optical scans of the dental arches, scans of impressions, scans of plaster models, or 3D digital x-rays. Such data can be manipulated to create a digital description of wires and brackets that can be designed in a sequential series that change over time as teeth move.

One such prototyping machine the may be used in accordance with the invention is the Objet260 Connex™ Compact Multi-Material 3D Printing System. The Objet260 Connex™ is a compact multi -material 3D printer that enables the rapid building of prototypes to match the intended end-product. The Objet260 Connex™ enables a choice of over 60 different building materials, and can simultaneously build 14 different materials into a single end model. The Objet260 Connex™ also enables selection of up to 51 composite, Digital Materials™ simulating anything from rubber to transparency to rigid ABS-grade engineering plastics. Examples of such Digital Materials™ is provided at http://www.obiet.eom/Portals/0/docs2/DM Datasheet letter.pdf, which disclosure is hereby incorporated by reference in its entirety. The Objet260 Connex™ also provides 16-micron, high-resolution print layer accuracy, multi-material 3D printing, small-office compatibility with a 260 x 260 x 200mm (10.02 x 10.02 x 7.9") tray size, and easy-to-insert materials in fully-sealed cartridges. A more complete description of the Objet260 Connex™, its functions and capabilities is provided at http://www.objet om/Portals/0/docs2/C260_letter_il_en_lowres.pdf, which disclosure is hereby incorporated by reference in its entirety. Other existing rapid manufacturing processes that may be used in accordance with the present invention include SLA (Stereo Lithography), SLS (Selective Laser Sintering), FDM (Fused Deposition Modeling), 3D printing (Polyjet), as well as others currently under development.

The above, and other aspects, features and advantages of the present invention, will become apparent from the following description read in conjunction with the accompanying drawings, in which like reference numerals designate the same elements, all of which form a part of this specification.

BRIEF DESCRIPTION OF THE DRAWINGS A further understanding of the present invention can be obtained by reference to a preferred embodiment set forth in the illustrations of the accompanying drawings. Although the illustrated preferred embodiment is merely exemplary of methods, structures and compositions for carrying out the present invention, both the organization and method of the invention, in general, together with further objectives and advantages thereof, may be more easily understood by reference to the drawings and the following description. The drawings are not intended to limit the scope of this invention, which is set forth with particularity in the claims as appended or as subsequently amended, but merely to clarify and exemplify the invention. For a more complete understanding of the present invention, reference is now made to the following drawings in which:

FIG. 1 is a drawing of a cross section and portion of the wire (in enlarged view), showing exemplary use of five material strands, in wedge-shaped cross section, in helical parallel about a hollow core.

FIG. 2 is a drawing of a portion of the wire (in enlarged view), showing exemplary use of five material strands, in wedge-shaped cross section, braided about a stranded core.

FIG. 3 is a cross section of the wire (in enlarged view), showing exemplary circular strands assembled about a stranded core.

FIG. 4 is a cross section of the wire (in enlarged view), showing exemplary circular strands assembled about a hollow core.

FIGs. 5 A-5D are a view of a wire cross-section in a progression of each of the steps involved in assembling a wire having an exterior sheath to which heat, light or electrical charge can be applied to form an integrated wire, wherein:

FIG. 5A is representative of the cross section of a wire sheath; FIG. 5B is representative of the cross-section of an exemplary use of six sheathed strands in helical parallel about a core; FIG. 5C is representative of the sheathed strands of FIG. 5B having been threaded within the wire sheath of FIG. 5 A; FIG. 5D is representative of the assembled wire of FIG. 5C after application of heat, light or electricity so as to form an integrated sheathed wire. FIG. 6 is a drawing of a wire having an optional molar terminal endcap attached to each end.

FIG. 7 A is a flowchart of the method of the present invention.

FIG. 7B is a continuation of the flowchart of FIG. 7 A.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Reference will now be made in detail to several embodiments of the invention that are illustrated in the accompanying drawings. Wherever possible, same or similar reference numerals are used in the drawings and the description to refer to the same or like parts or steps. The drawings are in simplified form and are not to precise scale. For purposes of convenience and clarity only, directional terms, such as top, bottom, up, down, over, above, and below may be used with respect to the drawings. These and similar directional terms should not be construed to limit the scope of the invention in any manner. The words "connect," "couple," and similar terms with their inflectional morphemes do not necessarily denote direct and immediate connections, but also include connections through mediate elements or devices. Turning now to FIG. 1, there is shown a drawing of a cross section and portion of the wire 10 (in enlarged view), showing exemplary use of five material strands, in wedge-shaped cross section, in helical parallel about a hollow core 15.

The strands can be assembled in varied patterns, depending upon stability and flexibility. For instance, FIG. 2 is a drawing of a portion of the wire 20 (in enlarged view), showing exemplary use of five material strands, braided about a stranded core 25.

A clear view of the cross section of an exemplary wire is shown in FIG. 3, where a cross section of the wire 30 (in enlarged view), shows exemplary circular strands 33 assembled about a stranded core 37. FIG. 4, on the other hand, is a cross section of the wire 40 (in enlarged view), showing exemplary circular strands 43 assembled about a hollow core 47.

Turning then to FIG. 5A, there is shown a cross section of a wire sheath 50. The composition of the wire sheath 50 is such that the application of heat will cause the wire sheath 50 to soften and form a bond around one or more strands passing through the wire sheath 50.

FIG. 5B is a cross section of an exemplary use of six sheathed strands (52a-f) in helical parallel about a sheathed core strand 52g. The composition of the strand sheaths is such that the application of heat, light or electricity, or other process, will cause the sheaths to soften and form a bond with the one or more sheathed strands in contact with it; thus, forming a "shrinlc-for-fit" application. FIG. 5C is a cross-section of the sheathed strands (52a-g) of FIG. 5B having been threaded within the wire sheath 50 of FIG. 5 A.

FIG. 5D is a cross-section of the assembled wire 56, of FIG. 5C, after application of heat so as to form an integrated sheathed wire.

With the wire assembled, the wire can be provided the end-user uncured, or cured in a straight length, or shaped in a form approximating industry standard dental arch form, or can be formed in a customized dental arch form as specified by the end-user. Wire braid can be non-uniform across the cross section or linearly along the wire with different sections of the wire to be applied to different teeth, or to different parts of the dental arch. This will allow for varying stiffness or elastic characteristics, or force of delivery at different portions of the dental arch.

Peripheral devices can be added, if required, so as to be able to accomplish the goals of the orthodontic procedure. FIG. 6 is a drawing of an orthodontic wire 60 having an optional molar terminal endcap 63 on either end of the wire, and attached 67 to each end.

FIG. 7A is a flowchart of the method of the present invention. The method flow begins at step 100 where the wire assembly process is initiated. From step 100, the flow advances to step 102 where the end use of the wire to be assembled is determined. The end use of the wire determines the selection of the type of wire to be used. Or, if the wire is a custom build, then the end use determines the composition or characteristics of the one or more strands for use in building the orthodontic wire.

From step 102, the flow advances to step 104 where the end-use characteristics are compared to a matrix for deteraiining what kind of wire is required to satisfy the end-use. The comparison is made by querying a database 106b as to available wire types that match the required characteristics of the end use. If the required wire is not available, then the flow queries database 106a as to the strands required to build a custom orthodontic wire. Databases 106a and 106b can be co-located, or remote to each other depending upon the needs of the host system. From step 104, the flow advances to a query at step 108 which asks if the required wire is custom. If the response to the query is "NO", then the flow advances to step 114 where the appropriate wire is selected from stock. From step 114, the flow advances to the query at step 116. Returning to step 108, if the response to the query is "YES", then the method advances to step 110 where a selection matrix is employed to determine the optimal selection of strands based upon material composition and ultimate end-use of the wire. Among the factors considered in determining the optimal strands for a given configuration, are: length of time for use of the wire; known allergies or sensitivities of the end-user; elasticity; amount of force delivery required; and, peripheral devices to be added. Force vectors can be applied to individual teeth or the dental arch as a whole. When the optimal strand combinations have been identified, the flow advances to step 112 where each of the strands to be joined together to form the orthodontic wire is selected and joined based upon the custom configuration requirements. The selected strands can be joined about a core. The core can be hollow (for improved flexibility), or can be comprised of an additional strand. From step 112, the method flow advances to the query at step 116. At step 1 16, the method queries as to whether or not sheathing is to be added to the wire. If the response to the query is "YES", then the sheathing is added at step 118 before advancing to the query at step 120. If, however, the response to the query at step 116 is "NO", then the method flow advances to reenter the system flow at step 120.

At step 120, the method queries as to whether or not a custom arch is to be formed. If the Response to the query is "YES", then the flow advances to step 122 where the arch is formed from the wire in accordance with the desired end-use. From step 122, the flow advances along path A to step 124 as is shown in FIG. 7B. Returning to the query at step 120, if the response is "NO", then the flow advances directly along path A to step 124. It should be noted that custom arch forms can be adapted at the factory, dentist, or local lab level.

In accordance with an alternative embodiment of the invention, the desired wire may be custom made through any of a number of rapid prototyping or manufacturing processes, such as Stereo Lithography (SLA), Selective Laser Sintering (SLS), Fused Deposition Modeling (FDM), or 3 -dimensional printing, as well as others currently under development. One such rapid manufacturing or prototyping machine is the Objet260 Connex™, as discussed above. Typically, the materials used for the orthodontic wires may be plastic, metal, glass, metal glass combinations, or any other suitable materials. Alternatively, using any of the rapid manufacturing processes, various materials can be combined, using a technique called overmodeling, in customized mixtures to create wires with various desired properties, such as elasticity, hardness, durability, etc. Accordingly, the feedstock utilized by such processes can be mixed before manufacture to create a wire with a uniform composition. Different feedstock can then be added in different layers or different portions for the orthodontic wire. Because these processes can be performed on-site at the practitioner's office, the wires can be customized for a particular patient and produced either individually or in a treatment progression series. Such rapid manufacturing or prototyping processes also enable the wires to be built up over a premade core such as nickel titanium (NiTi), a wire or resilient fiber to make a composite wire with any desired characteristics. Alternatively, the composition of the wire or the strands that comprise the wire can be varied to provide specified flexibility, elasticity, durability, etc. Optionally, the properties of the wire can vary across the cross section or linearly along the length of the wire, and different materials may be used in different parts of the wire to create these different properties. If desired, the wire can vary in geometry linearly along the length or across its cross-section. Using the rapid manufacturing process, any cross-section or wire geometry can be manufactui'ed as required by the practitioner. Similarly, the finished wire can be clear, translucent, or opaque, as required by the practitioner.

In yet another embodiment of the present invention, various polymers or other suitable materials may be used to manufacture wires using molds manufactured with the custom mold technique. Molds can be manufactured with all molds needed for a particular series of wires manufactured concurrently with a series of sprues connecting them to allow injection molding of all the wires to occur in one operation at the same time. Optionally, post processing can be used to alter the physical properties of the wire, such as elasticity, hardness, surface friction, state of polarization, functional aspects as light piping (e.g., refractive index modification). Coatings can be added, or the wire can be treated in chemical baths, with heat, pressure, visible or UV light for photosensitive materials, or other treatments. It will be further understand that one or more of the wires, or the wire sheathing can be selected and function as light piping or polarization effective to create a specific optical property to enhance esthetics (whitness, colorlessness, or a specific desired color) or to hide opaque parts of the wire or fixtures. It will be understood that esthetic wire-types may be used to hide, surround, or cover different more functional -type wires without departing from the scope and spirit of the present invention.

Turning then to FIG. 7B, path A is shown re-entering the system flow and advancing to step 124 where the wire is cut to its desired length. After the wire is cut to length at step 124, the flow advances to a query at step 126.

At step 126, the method queries as to whether or not the selected or assembled wire requires curing (generally via heat, light, or electrical input) to cause the sheaths of the wire and/or strands to soften and combine together, become stiffer, or more elastic, or be set into a specified shape. If the response to the query is "NO", then the flow advances to step 130. If, however, the response to the query at step 126 is "YES", then the flow advances to step 128 where the wire is cured before advancing to step 130. As a practical matter, wire can be shipped cured or uncured.

At step 130, the flow queries as to whether or not a peripheral is to be used with the wire. It should be noted, that the use of peripherals is optional, and exemplary. For instance, step 130 could be used to query as to other features or peripherals to be included with the wire. If the response to the query is "YES", then the flow advances to step 132 where the peripheral is attached to the wire. If, however, the response to the query at step 130 is "NO", then the flow advances to step 134 where the procedure is ended.

If the cut is done at the manufacturing site, then the wire will generally be packaged without any peripherals added thereto and shipped to a wholesaler, retailer, and/or procedural user. If the wire is cut at the procedural site (i.e., by the orthodontist), then a peripheral such as a molar endcap, or similar device for bonding to a tooth, or for other orthodontic functions, could be secured (if end-use conditions warrant) to the cut wire, at step 128, for use in the orthodontic procedure.

It will be noted that the term "wire", as used herein, refers to an elongated, semi-flexible member, such that there is no limitation as to the degree of flex, composition, or construction materials. Indeed, the phrase 'wire' may actually refer to multi-strands of different separate 'wires' with no confusion to those of skill in the art.

In the claims, means or step-plus-function clauses are intended to cover the structures described or suggested herein as performing the recited function and not only structural equivalents but also equivalent structures. Thus, for example, although a nail, a screw, and a bolt may not be structural equivalents in that a nail relies on friction between a wooden part and a cylindrical surface, a screw's helical surface positively engages the wooden part, and a bolt's head and nut compress opposite sides of a wooden part, in the environment of fastening wooden parts, a nail, a screw, and a bolt may be readily understood by those skilled in the art as equivalent structures.

Having described at least one of the preferred embodiments of the present invention with reference to the accompanying drawings, it is to be understood that such embodiments are merely exemplary and that the invention is not limited to those precise embodiments, and that various changes, modifications, and adaptations may be effected therein by one skilled in the art without departing from the scope or spirit of the invention as defined in the appended claims. The scope of the invention, therefore, shall be defined solely by the following claims. Further, it will be apparent to those of skill in the art that numerous changes may be made in such details without departing from the spirit and the principles of the invention. It should be appreciated that the present invention is capable of being embodied in other forms without departing from its essential characteristics.

Claims

WHAT IS CLAIMED IS:

1. An orthodontic wire comprising:

(a) a plurality of strands of an elastic material, said plurality of strands being layered in helical parallel co-axially about a core; and, wherein

(i) at least one of said wire and at least one of said strands is sheathed in a polymeric, bio-suitable, non-abrasive material; and

(ii) each one of said strands is selected to form an optimal combination based on material composition and as determined by a goal established for a use of said wire.

2. The orthodontic wire of claim 1, wherein said orthodontic wire includes at least one non-metallic strand.

3. The orthodontic wire of claim 1, wherein said material for each of said strands is selected from a group further comprising:

(a) a fiber re-enforced composite;

(b) a glass;

(c) a nucleated glass;

(d) a polymer;

(e) a monomer;

(f) a nickel titanium NiTi) compound;

(g) a metal alloy;

GO a curable resin; and

(0 a thermoset plastic.

4. The orthodontic wire of claim 1, wherein a cross-section of each of said plurality of strands is one of circular, rectilinear, rectangulai", ovoid, semi-circular, or of polygonic cross-section.

5. The orthodontic wire of claim 1, wherein respective cross-sections of each of said strands is shaped so as to facilitate coupling of said strands to provide an overall smoother profiled wire.

6. The orthodontic wire of claim 1 , wherein said plurality of strands is comprised of at least two strands wherein said at least two strands are comprised of different materials.

7. The orthodontic wire of claim 1, wherein said plurality of strands is comprised of at least two strands wherein said at least two strands are comprised of non-metallic strands of the same material.

8. The orthodontic wire of claim 1, wherein said material is one of a group consisting of:

(a) a radio opaque material;

(b) an optically transparent material;

(c) an optically translucent material; and

(d) an optically opaque material.

9. The orthodontic wire of claim 1, wherein each one of said plurality of strands is of the same non-metallic, elastic material.

10. The orthodontic wire of claim 1, wherein at least one of said plurality of strands is of a metallic material.

1 1. The orthodontic wire of claim 1, wherein said core, co-axially enclosed by said strands, is hollow.

12. The orthodontic wire of claim 1, said wire further comprising retaining means for retaining said wire in bonded relationship with a supporting molar.

13. The orthodontic wire of claim 12, wherein said bonding means further comprises bis-GMA.

14. The orthodontic wire of claim 1, wherein said sheathing is one of:

(a) an optically transparent material;

(b) a translucent material; and

(c) an opaque material;

wherein said sheathing further comprises bonding means selected from the group comprising:

(i) thermal bonding means for thermally forming an integrated coating along said wire when under heat;

(ii) electrical bonding means for electrically forming an integrated coating along said wire when under an electric current; and

(iii) photo bonding means for photo forming an integrated coating along said wire when under a light beam.

15. A method for providing an orthodontic wire for use in an orthodontic procedure, said method comprising the steps of:

(a) selecting a plurality of strands to be joined;

(b) joining a plurality of strands of elastic material in a helical parallel co-axially about a core, wherein at least one strand of said plurality of strands is non-metallic;

(c) cutting said wire to a selected length; and

(d) securing said wire to a set of teeth to be aligned by said orthodontic procedure.

16. The method of claim 15, where said plurality of strands is selected from a set of strands of varied material composition, said method further comprising the steps of:

(a) determining an optimal mix of strands for combination to form said plurality of strands, said mix dependent upon a set of conditions established for each of a plurality of orthodontic procedures; and

(b) forming said optimal mix of strands.

17. The method of claim 16, wherein said conditions are selected from the group comprising:

(a) length of time of use of said wire;

(b) tension required to optimally support said orthodontic procedure;

(c) elasticity required to optimally support said orthodontic procedure; and

(d) sensitivity of a patient with respect to end-use of said wire.

18. The method of claim 16, further comprising the step of establishing a matrix in respect of said conditions.

19. The method of claim 15, wherein at least one strand of said plurality of strands is one of:

(a) radio-opaque;

(b) translucent;

(c) transparent; and

(d) visually opaque.

20. The method of claim 15, further comprising the step of securing said wire to a respective molar by using a resin to effect a bond therewith.

21. An orthodontic wire, said wire comprising:

a. a plurality of strands of an elastic material, said strands being braided co-axially about a core and wherein at least one strand of said plurality of strands is radio-opaque; and

(b) a plurality of characteristics, said characteristics for optimizing comfort and use by a patient.

22. The orthodontic wire of claim 21, said wire further comprising retaining means for retaining said wire to a selected set of teeth at both the distal end and the proximate end of said wire.

23. The orthodontic wire of claim 21, wherein said orthodontic wire can be produced of varying cross-sectional geometry.

24. The orthodontic wire of claim 21, wherein said orthodontic wire can be produced of varying longitudinal geometry.

25. A method for providing an orthodontic wire for use in an orthodontic procedure, said method comprising the steps of:

a. obtaining digital data indicative of a desired characteristics of an orthodontic wire comprising a plurality of strands; b. manipulating said data to provide a digital description of he desired wire; and

c. entering said manipulated data into a rapid manufacturing machine, wherein said machine utilizes said data to create said orthodontic wire.

26. The method of claim 25, where said digital data is obtained from optical scans of conditions selected from the group consisting of dental arches, impressions, plaster models, and digital x-rays.

27. The method of claim 25, wherein said method further comprises the steps of:

d. determining an optimal mix of strands for combination to form said wire, said mix dependent upon a set of conditions established for each of a plurality of orthodontic procedures in said machine; and

e. determining an optimal strength cross section and along the length of said wire according t said set of conditions..

28. The method of claim 27, wherein said conditions are selected from the group comprising:

(a) length of time of use of said wire;

(b) tension required to optimally support said orthodontic procedure; (c) elasticity required to optimally support said orthodontic procedure; and

(d) sensitivity of a patient with respect to end-use of said wire..

29. The method of claim 27, fuither comprising the step of establishing matrix in respect of said conditions.

The method of claim 25, wherein at least one strand of said wire is one

(d) radio-opaque;

(e) translucent;

(f) transparent;

(d) visually opaque; and

(e) polarizing.

30. The method of claim 25, wherein material for each of said strands selected from the group consisting of:

(a) a fiber re-enforced composite;

(b) a glass;

(c) a nucleated glass;

(d) a polymer;

(e) a monomer;

(f) a nickel titanium (NiTi) compound; (g) a metal alloy;

(h) a curable resin; and

(i) a thermoset plastic.

31. The method of claim 25, wherein said machine utilizes a process selected from the group consisting of injection molding, stereo lithography, selective laser sintering, fused deposition modeling, and 3-dimensional printing.

32. The method of claim 25, wherein a cross-section of each of said plurality of strands is one of circular, rectilineal', rectangular, ovoid, semi-circular, or polygonic.

33. The method of claim 25, wherein said plurality of strands is comprised of at least two strands wherein said at least two strands are comprised of different materials.

34. The method of claim 25, wherein at least one of said plurality of strands is of a metallic material. 35 The method of claim 25, wherein at least one of said plurality of strands is varied by one of a strength and a density concentration along one of a cross- sectional view and along a length thereof, whereby the performance of said one of said strands is discontinuous along said length or along said cross-section.