WO1998002109A2 - Orthodontic archwire and method of manufacture - Google Patents

Orthodontic archwire and method of manufacture Download PDF

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Publication number
WO1998002109A2
WO1998002109A2 PCT/US1997/012075 US9712075W WO9802109A2 WO 1998002109 A2 WO1998002109 A2 WO 1998002109A2 US 9712075 W US9712075 W US 9712075W WO 9802109 A2 WO9802109 A2 WO 9802109A2
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Prior art keywords
mandrel
wire
archwire
heating
heating elements
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PCT/US1997/012075
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French (fr)
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WO1998002109A3 (en
Inventor
Brian Vernon Finander
Richard Allen Monsen
Brian Thomas Berg
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Flexmedics Corporation
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Publication of WO1998002109A2 publication Critical patent/WO1998002109A2/en
Publication of WO1998002109A3 publication Critical patent/WO1998002109A3/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61CDENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C7/00Orthodontics, i.e. obtaining or maintaining the desired position of teeth, e.g. by straightening, evening, regulating, separating, or by correcting malocclusions
    • A61C7/12Brackets; Arch wires; Combinations thereof; Accessories therefor
    • A61C7/20Arch wires

Definitions

  • the invention relates to archwires of the type used by orthodontists to straighten teeth, and to methods of manufacturing such archwires.
  • Orthodontic treatment involves the controlled and gradual movement of malaligned teeth to positions which are aesthetically satisfactory or functionally more effective. This process is ordinarily begun by attaching brackets to individual teeth either by bands which encircle the individual teeth, or by means of specially developed dental adhesives. Slots are provided in the brackets to receive and secure an orthodontic archwire that is generally shaped to correspond with the desired position of the teeth. Orthodontic archwires are made of resilient metallic wire to impart flexural and/or torsional restorative forces to the teeth, and over the course of treatment, different archwires may be sequentially used to enable adjustment of the amount and direction of forces applied to the teeth. Other techniques are also available to allow an orthodontist to finely adjust the forces to be applied to a malaligned tooth.
  • Treatment must take place over a period of time sufficient to allow the resorption of bone structures carrying a tooth on the side of the tooth facing the direction of desired movement, and concurrent apposition of bone on the other side of the tooth. In this way, teeth will be less subject to eventual return to a malaligned configuration.
  • Stainless steel archwires feature the advantages of excellent biocompatibility, formability, and low cost. Formabtlity of stainless steel archwires is needed to enable an orthodontist to periodically finely shape an archwire to allow for individual differences in a patient's teeth and for differences occurring due to placement of brackets on the teeth. This is normally accomplished by creating precise bends in the archwire. Loops or other extreme bends in archwires are sometimes used to create a spring-like action to draw teeth together or force teeth apart. Round stainless steel archwires were the first to be widely used. These archwires rotated freely within the brackets and thus imparted no torque to the teeth.
  • Nitinol may exhibit known "shape memory" characteristics: a nitinol object that is deformed at a low temperature regains its original shape when heated to a higher temperature. Nitinol may also have superelastic characteristics.
  • Superelasticity refers to the ability of a metal alloy such as nitinol to be elastically deformed to a far greater extent than an ordinary metal without taking a permanent set, assuming that certain temperature limits are maintained throughout the period of deformation. The characteristics of superelasticity are based on the crystalline phase changes associated with reversible martensitic shear transformation.
  • nitinol in general, nitinol, as well as other superelastic alloys (often called shape memory alloys) basically exists in either of two crystallographic forms. Which form the alloy will be in depends upon several variables including temperature, chemical composition, thermomechanical history, and the state of physical stress the alloy is in. Austenite, the parent or high temperature phase, is characterized by a body centered cubic structure. Martensite is the low temperature phase, characterized by a monoclinic crystalline structure. Assuming that a superelastic alloy such as nitinol is not highly cold worked, the alloy will change from austenite to martensite on cooling below a certain temperature, and will change back to austenite on heating.
  • the transformation from austenite to martensite can occur at constant temperature by the imposition of stress (referred to as stress-induced martensite), and the transformation is reversed when the stress is removed.
  • stress-induced martensite Nitinol orthodontic archwires have been developed which use shape memory properties, but archwires utilizing superelasticity have been more commercially successful and widespread.
  • Superelastic archwires undergo great elastic deformations at substantially constant stress levels.
  • Nonsuperelastic alloys, such as stainless steel exhibit approximate linear proportionality (Hooke's law) between stress and strain when subjected to a stress range below that producing plastic deformation.
  • nitinol behaves quite differently from stainless steel. As a . nitinol archwire recovers from even severe deformation imposed on the wire by a tooth, the force imparted to the tooth by the wire remains substantially constant. Thus, the corrective force imparted to a severely malaligned tooth may be about the same as the force imparted to a less malaligned tooth. Nitinol archwires thus provide much greater comfort to a patient by offering lower and more constant corrective forces over a large range of tooth movement.
  • an orthodontist will initiate orthodontic treatment using a nitinol archwire.
  • a nitinol archwire will exhibit substantially constant, low forces at large deflections which may be needed to accommodate a patient's individually malaligned teeth.
  • the orthodontist may switch to a stainless steel archwire to finish the treatment. Fine adjustment of an archwire to an individual patient's teeth may require the orthodontist to bend the wire, or even to create needed loops in the wire. This would not be possible with superelastic nitinol because of its inherent ability to resist taking a permanent set.
  • nitinol orthodontic archwires are manufactured by tightly winding a nitinol wire around a ceramic mandrel shaped like an archwire. Following winding of the wire on the mandrel, the wire is physically restrained to prevent it from unwinding and is heated by resistance heating. This heat treatment permanently trains the nitinol wire in the shape of the mandrel and imparts superelastic characteristics to the wire. The process is time consuming, as well as labor and energy intensive.
  • the invention is directed to an orthodontic archwire that combines the desirable characteristics of a superelastic orthodontic archwire to provide substantially constant tooth correcting forces over a wide range of movement, with the desirable property of a stainless steel archwire to assume a permanent set when appropriately bent by an orthodontist.
  • the archwire is formed of a nickel/titanium/iron alloy and is semisuperelastic in that it exhibits superelastic properties when subjected to strain but, when bent to an imposed bending strain of 8% or more, undergoes plastic flow and resultant permanent set.
  • the invention in another embodiment, relates to a method of forming an archwire having these desired properties at room temperature by forming a wire of nickel/titanium/iron alloy to a desired shape on a mandrel. While held in the desired shape, the wire is subjected to a rapid heat treatment in which the wire is raised to a target temperature of above 400°C (and preferably within the range of 450°C to 600°C) and is cooled, the wire being subjected to temperatures above 400°C for no longer than 15 minutes. It will be appreciated that the archwire is not held at its target temperature for any significant amount of time, but rather is heated up and cooled down rapidly. In this manner, not only are desired properties imparted to the archwire, but the time required for manufacture is minimized.
  • the archwire of the invention combines the ability of the wire to exert low and substantially constant forces against malaligned teeth, as is characteristic of superelastic alloys, with bendability similar to that of stainless steel archwires.
  • orthodontic treatment may require fewer archwire changes, leading to fewer office visits and lower cost to the patient. Treatment time also may be reduced, further lowering the cost.
  • the archwire of the invention may be used throughout orthodontic treatment but may be particularly effective in the final stages of treatment as a finishing wire or as a retainer.
  • the invention relates to an apparatus and method for heat treating archwires or other objects to form them into desired shapes.
  • the apparatus comprises a mandrel having a surface onto which the object may be trained, and means are provided for maintaining the object in heat-conducting contact with such surface.
  • the mandrel has one or more cavities having internal walls.
  • One or more heating elements are provided, the heating elements being respectively shaped for reception in respective cavities to conduct heat to the interior walls of the cavities, the heating elements being capable of heating said surface of the mandrel to a temperature of at least 350°C and preferably at least 450°C.
  • the cavities in the mandrel extend completely through the mandrel to provide cooling channels through which air or other cooling fluid may be flowed upon removal of the heating elements.
  • the heating elements may be heated by various means, such as by heat transfer from a hot fluid such as air, but preferably are electrically powered, and the apparatus may include a controller having means for sensing the temperature of said mandrel surface and for discontinuing heating of the heating elements when a predetermined temperature is sensed.
  • the mandrel has an outer surface about which a metal wire such as the nickel/titanium/iron alloy referred to above may be wound as a coil, the mandrel cavities comprising a series of apertures extending generally perpendicular to the plane defined by the wire coil.
  • the heating elements are provided as a series of rods shaped to be snugly but releasably received in the apertures.
  • the mandrel is of any heat-conducting material but preferably is metal such as aluminum or steel or the like to facilitate the conduction of heat from the heating elements to the mandrel surface carrying the wire coil.
  • a temperature sensing device such as a thermocouple positioned at or closely adjacent the surface of the mandrel, is provided to sense the surface temperature.
  • a controller is provided that is responsive to the sensed temperature to shut off electrical energy to the heating elements when the surface of the mandrel reaches a predetermined target temperature.
  • the method of using the apparatus involves first shaping or training the object to be heat-treated to the mandrel surface and securing the object in place.
  • the mandrel, with heating elements inserted, is heated by the heating elements to the desired temperature, following which the heating elements are removed and cooling air or other fluid, preferably gaseous, is flowed into and preferably through the now open cavities to cool the mandrel surface.
  • the mass of the mandrel and the number, size and location of the apertures and heating elements are chosen to avoid significant temperature variations across the mandrel surface, and to enable the rapid heating and cooling of the mandrel surface.
  • Figure 1 shows a schematic drawing of an apparatus of the invention
  • Figures 2A, 2B and 2C show bending stress versus bending strain curves for archwires of stainless steel, of superelastic nitinol, and of a bendable, semisuperelastic nickel/titanium/iron alloy of the invention, respectively.
  • FIG. 1 An apparatus of the invention is depicted in Fig. 1.
  • a mandrel is shown at 10, the mandrel comprising a body 11 formed of a highly heat-conducting material such as a metal, preferably an aluminum alloy.
  • the mandrel body 11 includes parallel end walls 15 spaced from each other by a curved exterior wall having an exterior surface 13 upon which a wire may be coiled, as shown.
  • a screw 9 or other means may be used to secure the ends of the wire to the mandrel.
  • the exterior surface 13 has a generally oval configuration in cross-section to provide the correct desired archwire curvature. It will be understood that after the heat treatment, the resulting wires forming the oval coil will be cut at point A so that each full coil forms two archwires.
  • a series of elongated, parallel apertures 12 are formed in the body 11 along axes generally perpendicular to the parallel end walls 15, the apertures preferably extending completely through the body 11.
  • a series of electrically powered heating elements are shown as 14, the elements being so configured as to be received in the respective apertures 12 in surface-to-surface contact with interior walls of the apertures to provide for good heat conduction from the heating elements 14 to the mandrel body 11.
  • the heating elements 14 preferably are simple resistance heaters and are formed as elongated rods, as shown. Desirably, both the apertures 12 and the heating elements 14 are circular in cross section to simplify insertion and withdrawal of the heating elements.
  • the heating elements may be harnessed or yoked together by a yoke 19 to enable the heating elements to be removed from the apertures simultaneously.
  • the heating elements include power cords 17 that extend to a controller 16, which may comprise a simple variable transformer of known design, the controller being powered by an electric source.
  • a controller 16 may comprise a simple variable transformer of known design, the controller being powered by an electric source.
  • a thermocouple lead 18 is attached to or closely adjacent the surface 13, as shown in the drawing. Through any of various known control circuits, the controller responds to the thermocouple to shut off the supply of electricity to the elements 14 when a predetermined target temperature is sensed.
  • the elements 14 are positioned in the apertures 12, and power is supplied to the elements to heat the wire coil to a target temperature of, for example, 600°C. Upon reaching the target temperature, power to the heating elements is discontinued. The elements 14 are removed from the apertures, and air or other gaseous cooling fluid such as argon or nitrogen is flowed into and preferably through the apertures to cause the mandrel and wire coil to cool.
  • a target temperature for example, 600°C.
  • Figure 1 depicts a mandrel 10 having a shape suitable for use as an orthodontic archwire
  • the invention encompasses training other materials, particularly metals and most preferably metal alloys having superelastic or semisuperelastic properties, into shapes which would be useful in other applications.
  • Various superelastic alloy wires can be used in the apparatus of the invention, the most successful and well known of which is nitinol, an alloy comprised of a near equiatomic mixture of nickel and titanium.
  • a further advantage to using the system of the present invention is that it is highly compatible with automated manufacturing processes. That is, superelastic wire may be wound by machine onto the mandrel so that each wire turn contacts the surface 13.
  • the heating elements 14 may be automatically inserted and removed at the appropriate times, followed by automatic cooling by commencing flow of a cooling fluid through the apertures.
  • Bending stress and bending strain as referred to below are measured by three point loading of archwire workpieces of circular cross section and of wire diameter D in which the wire is supported by supports separated by a distance L and a load is applied midway between the supports to provide a maximum deflection S. Strain is given by the formula 6DS/L 2 and is commonly expressed in percentage terms.
  • the stress/strain curves of Figures 2A, 2B and 2C were derived from three point loading measurements in which L was 10 wire diameters and in which the maximum deflection S was 2.5 wire diameters, providing a strain at maximum deflection of 15%.
  • the wire is characterized as being "semisuperelastic"; that is, when bent to an imposed bending strain between about 3% and 10%, the archwire exhibits both reversible stress-induced martensite formation and plastic (non-recoverable) flow.
  • the wire exhibits both reversible stress-induced martensite formation and plastic flow, but the strain resulting from bending the wire beyond about 15% strain results primarily if not entirely in non-recoverable plastic flow.
  • the residual strain is less than half the imposed strain and preferably less than one-fourth the imposed strain.
  • the archwire may be appropriately bent and shaped by an orthodontist.
  • the stress-induced martensite behavior enables the archwire to undergo substantial deformation when being fitted to the teeth and to return to the teeth a low and substantially constant restoring force.
  • the property of the archwire to take a permanent set through plastic flow upon bending permits the archwire to be custom formed by the orthodontist to the needs of each individual patient.
  • the starting material is a wire of nickel/titanium/iron alloy, preferably containing by weight 50% to 56% of nickel, 38.7% to 49.5% of titanium and 0.5% to 5.3% of iron, the wire having been subjected to at least 30% cold working.
  • Cold working here refers to the process of drawing the wire to reduce its diameter, the percentage of cold working referring to the percentage reduction in wire area. Variations in elements and percentages may yield alloys that respond similarly to the heat treatment regime specified herein. Thus, the elements specified, and the percentages thereof are illustrative in connection with the following method.
  • the method involves heating the wire, while holding it in the desired shape, to a temperature in excess of 400°C and preferably at least 450°C, the wire being permitted to remain above 400°C for no more than 15 minutes.
  • a temperature in excess of 400°C and preferably at least 450°C the wire being permitted to remain above 400°C for no more than 15 minutes.
  • FIGS. 2A, 2B and 2C are three-point bending stress/bending strain curves for archwires that were stressed in bending to 15% imposed strain and then unloaded while monitoring stress.
  • Figure 2A presents the curve 50 for a stainless steel orthodontic archwire.
  • the initial region 52 of the curve represents the Hooke's Law region in which the wire is deformed elastically, stress and strain being approximately proportional.
  • the plastic flow region is designated 54.
  • Region 56 of the curve shows the stress returned by the wire as it is unloaded; note may be made of the high level of stress returned by the wire.
  • a severely malaligned tooth will thus be subjected to substantial and often painful restorative forces when use is made of a stainless steel archwire.
  • Stainless steel archwires provide only a small working range of movement: after only a small degree of tooth movement, the wire must be readjusted, leading to frequent office visits. Also, note the large amount of set or residual strain at zero stress, showing the large amount of plastic flow at this relatively moderate deformation.
  • Figure 2B presents the curve 60 for a commercially available superelastic nitinol archwire.
  • the initial region 62 of the curve represents the Hooke's Law region in which stress and strain are approximately proportional. In comparison to the stainless steel archwire, this region is quite abbreviated and ends abruptly.
  • a second region 64 of the curve illustrates the superelastic characteristic of the nitinol in which substantially fully recoverable strain occurs with little if any increase in stress. This region of the curve reflects the transformation of austenite crystalline structure to martensite crystalline structure, sometimes referred to as stress-induced martensite, that results from increased deformation or imposition of external stress.
  • Curve region 66 reflects the stress returned by the wire as it is unloaded while monitoring stress, stress-induced martensite being transformed to austenite.
  • FIG. 2C presents the curve 70 for a nickel/titanium/iron alloy wire having about 30% cold working.
  • a mandrel bearing coils of the wire was quickly heated by an apparatus of the invention described above with reference to Figure 1 from room temperature to a temperature of 500°C in approximately 7 minutes and was then immediately cooled to below 200°C in an additional 7 minutes, the dwell time of the wire above 400°C being approximately 6 minutes.
  • the initial region 72 of the curve represents the Hooke's Law region in which stress and strain are approximately proportional.
  • a second region 74 of the curve illustrates the semisuperelastic characteristic of this alloy.
  • stress induced martensite is formed as a result of the imposition of external stress to the alloy.
  • the substantially constant forces corresponding to varying and increasing amounts of strain imposed on the wire are similar to the forces expected from superelastic nitinol, with the difference being that the wire of the present invention is seen to return slightly higher forces.
  • Curve region 76 reflects the stress returned by the wire as it is unloaded.
  • An orthodontist will begin orthodontic treatment by attaching orthodontic brackets to the teeth using traditional methods and materials.
  • An archwire of the present invention would then be placed in the brackets.
  • the forces exerted by the wire upon the malaligned teeth will be substantially constant and low, but slightly higher than superelastic nitinol would exert.
  • Use of the archwire of the present invention in the finishing phase of orthodontic treatment requires that the wire be provided with bends or other unusual shapes to finely shape the wire to the individual differences of each patient. This requires the orthodontist to overbend the wire to compensate for the inherent superelastic resistance of the wire to take a permanent set, as permitted by the archwires of the invention. The bending procedure is repeated until the desired degree of bend is achieved.
  • the archwire is secured by the orthodontic brackets previously attached to the patient's teeth.

Abstract

A superelastic orthodontic archwire made of an alloy of Nickel Titanium Iron combines substantially low and constant forces with bendability characteristics. This allows the same archwire to be used for all stages of orthodontic treatment. Also disclosed is a method of producing the archwire by winding a suitably shaped mandrel with Nickel Titanium Iron alloy wire and restraining the wire to secure its shape. The mandrel is provided with a plurality of apertures adapted to receive independent heat elements. Heat elements are inserted into the mandrel, and energized. A thermocouple is carried by the mandrel to detect a target temperature, whereupon a controller unit shuts off the heating elements. The heating elements are removed, and the mandrel with attached wires cooled at a suitable rate to maximize the desired characteristics entrained into the wire.

Description

Orthodontic Archwire and Method of Manufacture Field of the Invention
The invention relates to archwires of the type used by orthodontists to straighten teeth, and to methods of manufacturing such archwires. Background
Orthodontic treatment involves the controlled and gradual movement of malaligned teeth to positions which are aesthetically satisfactory or functionally more effective. This process is ordinarily begun by attaching brackets to individual teeth either by bands which encircle the individual teeth, or by means of specially developed dental adhesives. Slots are provided in the brackets to receive and secure an orthodontic archwire that is generally shaped to correspond with the desired position of the teeth. Orthodontic archwires are made of resilient metallic wire to impart flexural and/or torsional restorative forces to the teeth, and over the course of treatment, different archwires may be sequentially used to enable adjustment of the amount and direction of forces applied to the teeth. Other techniques are also available to allow an orthodontist to finely adjust the forces to be applied to a malaligned tooth.
Treatment must take place over a period of time sufficient to allow the resorption of bone structures carrying a tooth on the side of the tooth facing the direction of desired movement, and concurrent apposition of bone on the other side of the tooth. In this way, teeth will be less subject to eventual return to a malaligned configuration.
Materials traditionally used for orthodontic archwires include various stainless steel alloys. Stainless steel archwires feature the advantages of excellent biocompatibility, formability, and low cost. Formabtlity of stainless steel archwires is needed to enable an orthodontist to periodically finely shape an archwire to allow for individual differences in a patient's teeth and for differences occurring due to placement of brackets on the teeth. This is normally accomplished by creating precise bends in the archwire. Loops or other extreme bends in archwires are sometimes used to create a spring-like action to draw teeth together or force teeth apart. Round stainless steel archwires were the first to be widely used. These archwires rotated freely within the brackets and thus imparted no torque to the teeth. Also well known in the prior art are rectangular archwires, which, when used with compatible brackets, do allow torque to be applied to teeth. A major development in orthodontic treatment occurred with the introduction of archwires made of nickel/titanium alloy, as disclosed in U.S. patent 4,037,324 to Andreasen. Commonly known as nitinol, nickel/titanium alloys offer excellent biocompatibilty as well as several other characteristics. Nitinol may exhibit known "shape memory" characteristics: a nitinol object that is deformed at a low temperature regains its original shape when heated to a higher temperature. Nitinol may also have superelastic characteristics. "Superelasticity" refers to the ability of a metal alloy such as nitinol to be elastically deformed to a far greater extent than an ordinary metal without taking a permanent set, assuming that certain temperature limits are maintained throughout the period of deformation. The characteristics of superelasticity are based on the crystalline phase changes associated with reversible martensitic shear transformation.
In general, nitinol, as well as other superelastic alloys (often called shape memory alloys) basically exists in either of two crystallographic forms. Which form the alloy will be in depends upon several variables including temperature, chemical composition, thermomechanical history, and the state of physical stress the alloy is in. Austenite, the parent or high temperature phase, is characterized by a body centered cubic structure. Martensite is the low temperature phase, characterized by a monoclinic crystalline structure. Assuming that a superelastic alloy such as nitinol is not highly cold worked, the alloy will change from austenite to martensite on cooling below a certain temperature, and will change back to austenite on heating. Alternatively, the transformation from austenite to martensite can occur at constant temperature by the imposition of stress (referred to as stress-induced martensite), and the transformation is reversed when the stress is removed. Nitinol orthodontic archwires have been developed which use shape memory properties, but archwires utilizing superelasticity have been more commercially successful and widespread. Superelastic archwires undergo great elastic deformations at substantially constant stress levels. Nonsuperelastic alloys, such as stainless steel, exhibit approximate linear proportionality (Hooke's law) between stress and strain when subjected to a stress range below that producing plastic deformation. That is, when a stainless steel archwire is subjected to strain induced by a malaligned tooth, the wire exerts on the tooth a force that is proportional to the induced strain. Thus, a severely malaligned tooth produces greater deformation of a stainless steel archwire and accordingly the wire will exert on the tooth a high degree of force. This can result in great pain to the patient and potential root resorption of the tooth. An additional disadvantage of using a stainless steel archwire in situations involving severely malaligned teeth is that the high forces generated by the archwire can cause cemented archwire brackets to become detached from the teeth.
Superelastic nitinol behaves quite differently from stainless steel. As a . nitinol archwire recovers from even severe deformation imposed on the wire by a tooth, the force imparted to the tooth by the wire remains substantially constant. Thus, the corrective force imparted to a severely malaligned tooth may be about the same as the force imparted to a less malaligned tooth. Nitinol archwires thus provide much greater comfort to a patient by offering lower and more constant corrective forces over a large range of tooth movement.
Typically, an orthodontist will initiate orthodontic treatment using a nitinol archwire. As explained above, a nitinol archwire will exhibit substantially constant, low forces at large deflections which may be needed to accommodate a patient's individually malaligned teeth. As treatment progresses, the orthodontist may switch to a stainless steel archwire to finish the treatment. Fine adjustment of an archwire to an individual patient's teeth may require the orthodontist to bend the wire, or even to create needed loops in the wire. This would not be possible with superelastic nitinol because of its inherent ability to resist taking a permanent set. Traditionally, nitinol orthodontic archwires are manufactured by tightly winding a nitinol wire around a ceramic mandrel shaped like an archwire. Following winding of the wire on the mandrel, the wire is physically restrained to prevent it from unwinding and is heated by resistance heating. This heat treatment permanently trains the nitinol wire in the shape of the mandrel and imparts superelastic characteristics to the wire. The process is time consuming, as well as labor and energy intensive.
For the foregoing reasons, there is a need for a single orthodontic archwire possessing the desirable characteristics of both stainless steel and nitinol. There is also a need for a faster and more efficient heat treatment system, which may lend itself to modern automation technology. Brief Summary of the Invention
In one embodiment, the invention is directed to an orthodontic archwire that combines the desirable characteristics of a superelastic orthodontic archwire to provide substantially constant tooth correcting forces over a wide range of movement, with the desirable property of a stainless steel archwire to assume a permanent set when appropriately bent by an orthodontist. The archwire is formed of a nickel/titanium/iron alloy and is semisuperelastic in that it exhibits superelastic properties when subjected to strain but, when bent to an imposed bending strain of 8% or more, undergoes plastic flow and resultant permanent set. By "archwire", reference is made not only to the generally "U" shaped wires employed by orthodontists, but also to the various appliances that are used with the generally "U" shaped wires such as wire lengths bent into springs, loops and other shapes) and to partial or temporary appliances such as retainers.
In another embodiment, the invention relates to a method of forming an archwire having these desired properties at room temperature by forming a wire of nickel/titanium/iron alloy to a desired shape on a mandrel. While held in the desired shape, the wire is subjected to a rapid heat treatment in which the wire is raised to a target temperature of above 400°C (and preferably within the range of 450°C to 600°C) and is cooled, the wire being subjected to temperatures above 400°C for no longer than 15 minutes. It will be appreciated that the archwire is not held at its target temperature for any significant amount of time, but rather is heated up and cooled down rapidly. In this manner, not only are desired properties imparted to the archwire, but the time required for manufacture is minimized.
The archwire of the invention combines the ability of the wire to exert low and substantially constant forces against malaligned teeth, as is characteristic of superelastic alloys, with bendability similar to that of stainless steel archwires. As a result, orthodontic treatment may require fewer archwire changes, leading to fewer office visits and lower cost to the patient. Treatment time also may be reduced, further lowering the cost. It is contemplated that the archwire of the invention may be used throughout orthodontic treatment but may be particularly effective in the final stages of treatment as a finishing wire or as a retainer.
In further embodiments, the invention relates to an apparatus and method for heat treating archwires or other objects to form them into desired shapes. The apparatus comprises a mandrel having a surface onto which the object may be trained, and means are provided for maintaining the object in heat-conducting contact with such surface. The mandrel has one or more cavities having internal walls. One or more heating elements are provided, the heating elements being respectively shaped for reception in respective cavities to conduct heat to the interior walls of the cavities, the heating elements being capable of heating said surface of the mandrel to a temperature of at least 350°C and preferably at least 450°C. Preferably, at least some of the cavities in the mandrel extend completely through the mandrel to provide cooling channels through which air or other cooling fluid may be flowed upon removal of the heating elements. The heating elements may be heated by various means, such as by heat transfer from a hot fluid such as air, but preferably are electrically powered, and the apparatus may include a controller having means for sensing the temperature of said mandrel surface and for discontinuing heating of the heating elements when a predetermined temperature is sensed.
In a preferred embodiment, the mandrel has an outer surface about which a metal wire such as the nickel/titanium/iron alloy referred to above may be wound as a coil, the mandrel cavities comprising a series of apertures extending generally perpendicular to the plane defined by the wire coil. The heating elements are provided as a series of rods shaped to be snugly but releasably received in the apertures. The mandrel is of any heat-conducting material but preferably is metal such as aluminum or steel or the like to facilitate the conduction of heat from the heating elements to the mandrel surface carrying the wire coil. A temperature sensing device, such as a thermocouple positioned at or closely adjacent the surface of the mandrel, is provided to sense the surface temperature. A controller is provided that is responsive to the sensed temperature to shut off electrical energy to the heating elements when the surface of the mandrel reaches a predetermined target temperature. The method of using the apparatus involves first shaping or training the object to be heat-treated to the mandrel surface and securing the object in place. The mandrel, with heating elements inserted, is heated by the heating elements to the desired temperature, following which the heating elements are removed and cooling air or other fluid, preferably gaseous, is flowed into and preferably through the now open cavities to cool the mandrel surface. The mass of the mandrel and the number, size and location of the apertures and heating elements are chosen to avoid significant temperature variations across the mandrel surface, and to enable the rapid heating and cooling of the mandrel surface. These and other features, aspects, and advantages of the present invention will become better understood with reference to the following description and appended claims. Brief Description of the Drawings
Figure 1 shows a schematic drawing of an apparatus of the invention; and Figures 2A, 2B and 2C show bending stress versus bending strain curves for archwires of stainless steel, of superelastic nitinol, and of a bendable, semisuperelastic nickel/titanium/iron alloy of the invention, respectively. Detailed Description
An apparatus of the invention is depicted in Fig. 1. A mandrel is shown at 10, the mandrel comprising a body 11 formed of a highly heat-conducting material such as a metal, preferably an aluminum alloy. In the illustrated preferred embodiment, the mandrel body 11 includes parallel end walls 15 spaced from each other by a curved exterior wall having an exterior surface 13 upon which a wire may be coiled, as shown. A screw 9 or other means may be used to secure the ends of the wire to the mandrel. The exterior surface 13 has a generally oval configuration in cross-section to provide the correct desired archwire curvature. It will be understood that after the heat treatment, the resulting wires forming the oval coil will be cut at point A so that each full coil forms two archwires.
A series of elongated, parallel apertures 12 are formed in the body 11 along axes generally perpendicular to the parallel end walls 15, the apertures preferably extending completely through the body 11. A series of electrically powered heating elements are shown as 14, the elements being so configured as to be received in the respective apertures 12 in surface-to-surface contact with interior walls of the apertures to provide for good heat conduction from the heating elements 14 to the mandrel body 11. The heating elements 14 preferably are simple resistance heaters and are formed as elongated rods, as shown. Desirably, both the apertures 12 and the heating elements 14 are circular in cross section to simplify insertion and withdrawal of the heating elements. The heating elements may be harnessed or yoked together by a yoke 19 to enable the heating elements to be removed from the apertures simultaneously.
The heating elements include power cords 17 that extend to a controller 16, which may comprise a simple variable transformer of known design, the controller being powered by an electric source. To sense the temperature of the surface 13 of the mandrel (and thus sense the temperature of the wires coiled on that surface), a thermocouple lead 18 is attached to or closely adjacent the surface 13, as shown in the drawing. Through any of various known control circuits, the controller responds to the thermocouple to shut off the supply of electricity to the elements 14 when a predetermined target temperature is sensed.
Operation of the above described apparatus may best be described with respect to manufacture of an archwire. A wire of nitinol or the like is tightly wrapped around the curved mandrel surface 13 and is secured from unwinding from the mandrel by screws 9 or other appropriate means. The heating elements
14 are positioned in the apertures 12, and power is supplied to the elements to heat the wire coil to a target temperature of, for example, 600°C. Upon reaching the target temperature, power to the heating elements is discontinued. The elements 14 are removed from the apertures, and air or other gaseous cooling fluid such as argon or nitrogen is flowed into and preferably through the apertures to cause the mandrel and wire coil to cool.
Although Figure 1 depicts a mandrel 10 having a shape suitable for use as an orthodontic archwire, it will be recognized that the invention encompasses training other materials, particularly metals and most preferably metal alloys having superelastic or semisuperelastic properties, into shapes which would be useful in other applications. Various superelastic alloy wires can be used in the apparatus of the invention, the most successful and well known of which is nitinol, an alloy comprised of a near equiatomic mixture of nickel and titanium. A further advantage to using the system of the present invention is that it is highly compatible with automated manufacturing processes. That is, superelastic wire may be wound by machine onto the mandrel so that each wire turn contacts the surface 13. The heating elements 14 may be automatically inserted and removed at the appropriate times, followed by automatic cooling by commencing flow of a cooling fluid through the apertures.
Bending stress and bending strain as referred to below are measured by three point loading of archwire workpieces of circular cross section and of wire diameter D in which the wire is supported by supports separated by a distance L and a load is applied midway between the supports to provide a maximum deflection S. Strain is given by the formula 6DS/L2 and is commonly expressed in percentage terms. The stress/strain curves of Figures 2A, 2B and 2C were derived from three point loading measurements in which L was 10 wire diameters and in which the maximum deflection S was 2.5 wire diameters, providing a strain at maximum deflection of 15%.
Turning now to the archwire of the invention, the wire is characterized as being "semisuperelastic"; that is, when bent to an imposed bending strain between about 3% and 10%, the archwire exhibits both reversible stress-induced martensite formation and plastic (non-recoverable) flow. For example, at about 8% bending strain, the wire exhibits both reversible stress-induced martensite formation and plastic flow, but the strain resulting from bending the wire beyond about 15% strain results primarily if not entirely in non-recoverable plastic flow. When bent to an imposed 10% strain and then unloaded, the residual strain (representing plastic flow) is less than half the imposed strain and preferably less than one-fourth the imposed strain. In this manner, the archwire may be appropriately bent and shaped by an orthodontist. The stress-induced martensite behavior enables the archwire to undergo substantial deformation when being fitted to the teeth and to return to the teeth a low and substantially constant restoring force. On the other hand, the property of the archwire to take a permanent set through plastic flow upon bending permits the archwire to be custom formed by the orthodontist to the needs of each individual patient.
In the specific process for forming an archwire of the invention, the starting material is a wire of nickel/titanium/iron alloy, preferably containing by weight 50% to 56% of nickel, 38.7% to 49.5% of titanium and 0.5% to 5.3% of iron, the wire having been subjected to at least 30% cold working. "Cold working" here refers to the process of drawing the wire to reduce its diameter, the percentage of cold working referring to the percentage reduction in wire area. Variations in elements and percentages may yield alloys that respond similarly to the heat treatment regime specified herein. Thus, the elements specified, and the percentages thereof are illustrative in connection with the following method.
The method involves heating the wire, while holding it in the desired shape, to a temperature in excess of 400°C and preferably at least 450°C, the wire being permitted to remain above 400°C for no more than 15 minutes. Although various heating apparatuses and methods may be used, it will be understood that the apparatus described above in connection with Figure 1 is particularly adapted to this use in that it enables wire coils to be heated and cooled quickly. Cycle times (the time to raise the coil to a temperature of greater than 400°C and to immediately cool it to below 200°C) less than 20 minutes are preferred, and cycle times of about 14 minutes or less are most preferred. An orthodontic archwire resulting from subjecting a wire of the specified alloy to the heat treatment and cooling method of the present invention will combine the low and substantially constant force characteristics of a superelastic archwire with the bendability characteristics of a stainless steel archwire. Figures 2A, 2B and 2C are three-point bending stress/bending strain curves for archwires that were stressed in bending to 15% imposed strain and then unloaded while monitoring stress.
Figure 2A presents the curve 50 for a stainless steel orthodontic archwire. The initial region 52 of the curve represents the Hooke's Law region in which the wire is deformed elastically, stress and strain being approximately proportional.
The plastic flow region is designated 54. Region 56 of the curve shows the stress returned by the wire as it is unloaded; note may be made of the high level of stress returned by the wire. A severely malaligned tooth will thus be subjected to substantial and often painful restorative forces when use is made of a stainless steel archwire. Stainless steel archwires provide only a small working range of movement: after only a small degree of tooth movement, the wire must be readjusted, leading to frequent office visits. Also, note the large amount of set or residual strain at zero stress, showing the large amount of plastic flow at this relatively moderate deformation. Figure 2B presents the curve 60 for a commercially available superelastic nitinol archwire. The initial region 62 of the curve represents the Hooke's Law region in which stress and strain are approximately proportional. In comparison to the stainless steel archwire, this region is quite abbreviated and ends abruptly. A second region 64 of the curve illustrates the superelastic characteristic of the nitinol in which substantially fully recoverable strain occurs with little if any increase in stress. This region of the curve reflects the transformation of austenite crystalline structure to martensite crystalline structure, sometimes referred to as stress-induced martensite, that results from increased deformation or imposition of external stress. Curve region 66 reflects the stress returned by the wire as it is unloaded while monitoring stress, stress-induced martensite being transformed to austenite. It is the transformation from stress-induced martensite to austenite that is responsible for the low and substantially constant forces exhibited by superelastic nitinol archwires. The archwire returns to substantially its original configuration, indicating that the wire takes no permanent set as it is deformed. Figure 2C presents the curve 70 for a nickel/titanium/iron alloy wire having about 30% cold working. A mandrel bearing coils of the wire was quickly heated by an apparatus of the invention described above with reference to Figure 1 from room temperature to a temperature of 500°C in approximately 7 minutes and was then immediately cooled to below 200°C in an additional 7 minutes, the dwell time of the wire above 400°C being approximately 6 minutes. The initial region 72 of the curve represents the Hooke's Law region in which stress and strain are approximately proportional. Again in comparison to the stainless steel archwire of Figure 2A, this region is quite abbreviated and ends abruptly. A second region 74 of the curve illustrates the semisuperelastic characteristic of this alloy. As with superelastic nitinol, stress induced martensite is formed as a result of the imposition of external stress to the alloy. The substantially constant forces corresponding to varying and increasing amounts of strain imposed on the wire are similar to the forces expected from superelastic nitinol, with the difference being that the wire of the present invention is seen to return slightly higher forces. Curve region 76 reflects the stress returned by the wire as it is unloaded. Note that although low and substantially constant stress is returned by the wire through a large region of its recovery toward its original configuration, the wire does not return completely to that configuration. A certain amount of residual strain remains at the end of the unloading phase, indicting that the wire of the present invention had taken a permanent set as a result of deformation.
An orthodontist will begin orthodontic treatment by attaching orthodontic brackets to the teeth using traditional methods and materials. An archwire of the present invention would then be placed in the brackets. The forces exerted by the wire upon the malaligned teeth will be substantially constant and low, but slightly higher than superelastic nitinol would exert. Use of the archwire of the present invention in the finishing phase of orthodontic treatment requires that the wire be provided with bends or other unusual shapes to finely shape the wire to the individual differences of each patient. This requires the orthodontist to overbend the wire to compensate for the inherent superelastic resistance of the wire to take a permanent set, as permitted by the archwires of the invention. The bending procedure is repeated until the desired degree of bend is achieved.
Following proper bending, the archwire is secured by the orthodontic brackets previously attached to the patient's teeth.
While a preferred embodiment of the present invention has been described, it should be understood that various changes, adaptations, and modifications may be made without departing from the spirit of the invention and the scope of the appended claims.

Claims

What is claimed is:
1. An orthodontic archwire capable of providing low but substantially constant tooth correcting forces over a wide range of movement but capable of assuming a permanent set when appropriately bent by an orthodontist, the archwire comprising a nickel/titanium/iron alloy which, when subjected to between
3% and 10% of bending strain, exhibits both plastic flow and reversible stress- induced martensite formation.
2. The archwire of claim 1 wherein said alloy comprises by weight 50% to 56% of nickel, 38.7% to 49.5% of titanium and 0.5% to 5.3% of iron.
3. The archwire of claim 1 further characterized by undergoing both plastic flow and reversible stress-induced martensite formation when subjected to an 8% bending strain, but undergoing substantially only plastic flow when subjected to strain beyond 15%.
4. The archwire of claim 1 further characterized by the property of . retaining less than half the imposed bending strain when bent to an imposed strain of 10%.
5. A method of forming an orthodontic archwire which, when subjected to between 3% and 10% of bending strain, exhibits both plastic flow and reversible stress-induced martensite formation comprising forming a wire of nickel/titanium/iron alloy to the desired archwire shape and subjecting the wire to a rapid heat treatment in which the wire is raised to a target temperature above 400°C and then cooled, the wire being subjected to temperatures above 400°C for no longer than 15 minutes.
6. The method of claim 5 wherein said alloy comprises by weight 50% to 56% of nickel, 38.7% to 49.5% of titanium and 0.5% to 5.3% of iron, and is at least 30% cold worked.
7. The method of claim 5 wherein said target temperature is not less than 450°C.
8. The method of claim 5 wherein the time period for heating the wire from about room temperature to the target temperature and cooling the wire below 200°C is not greater than 20 minutes.
9. The method of claim 5 including the step of winding the wire onto a mandrel having at least one internal cavity carrying a removable heating element, heating the mandrel by means of said heating element to said target temperature, removing the heating element, and flowing a cooling fluid into the cavity to cool the mandrel and wire.
10. An apparatus for heat treating an object to form it into a desired shape, comprising a mandrel having a surface shaped in the desired shape and to which the object may be trained, and means for maintaining the object in heat- conducting contact with said surface, the mandrel having at least one cavity having internal walls, the apparatus including heating means comprising at least one heating element shaped for reception in and removal from said cavity, the heating element, when received in the cavity, providing heat energy to the mandrel to heat said shaped surface of the mandrel and the heating element being removable from the mandrel to enable a cooling fluid to flow into said cavity.
11. The apparatus of claim 10 wherein said heating means comprises a plurality of heating elements and wherein said cavity comprises a plurality of apertures sized and shaped to receive the heating elements and to enable the heating elements to be removed from the apertures.
12. The apparatus of claim 11 wherein said apertures extend entirely through the mandrel to enable a cooling gas to be flowed through the apertures to cool the mandrel.
13. The apparatus of claim 11 including a moveable yoke to which the heating elements are attached to enable simultaneous removal of the heating elements from the apertures.
14. The apparatus of claim 11 including a controller having means for sensing the temperature of said mandrel surface and for shutting off electrical power to the heating elements when a predetermined temperature is sensed.
15. A method for heat treating an object to form it into a desired shape, comprising providing a mandrel having a surface shaped in the desired shape, training the object to the shaped mandrel surface, maintaining the object in heat- conducting contact with said surface, inserting heating means into a cavity in the mandrel, heating the object to a target temperature, removing the heating means, and flowing a cooling fluid into the cavity to cool the mandrel and object.
16. The method of claim 15 wherein the mandrel has a plurality of apertures extending through the mandrel and wherein the heating means comprises a plurality of heating elements configured for reception in the respective apertures, the method including the step of flowing a coolant fluid through said apertures upon removal therefrom of the heating elements to rapidly cool the mandrel.
17. The method of claim 16 including the step of removing said heating elements from the respective apertures simultaneously.
18. The method of claim 15 wherein said object is heated by the mandrel from room temperature to a temperature above 400°C and is cooled to a temperature below 200°C in an elapsed time of not more than 20 minutes.
PCT/US1997/012075 1996-07-12 1997-07-11 Orthodontic archwire and method of manufacture WO1998002109A2 (en)

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US20220151738A1 (en) * 2020-11-19 2022-05-19 Dirk Wiechmann Process to program an orthodontic component from a shape memory material
CN114603013A (en) * 2022-02-16 2022-06-10 深圳高性能医疗器械国家研究院有限公司 Shaping method of super-elastic orthodontic material and obtained super-elastic orthodontic material

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US20220151738A1 (en) * 2020-11-19 2022-05-19 Dirk Wiechmann Process to program an orthodontic component from a shape memory material
US11813137B2 (en) * 2020-11-19 2023-11-14 Dirk Wiechmann Process to program an orthodontic component from a shape memory material
CN114603013A (en) * 2022-02-16 2022-06-10 深圳高性能医疗器械国家研究院有限公司 Shaping method of super-elastic orthodontic material and obtained super-elastic orthodontic material

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