Wire guard

Abstract

Devices and methods disclosed herein can include a guard including a support arm, a cantilever arm, and a shield. The support arm can have a lumen extending therethrough, the lumen can be configured to receive a wire. The cantilever arm can extend at least distally from the support arm, the cantilever arm configured to pivot about a pivot point; and a shield affixed to the cantilever arm, the shield being configured to cover one of a distal end of the wire or a bracket.

Description

WIRE GUARDCROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of and priority to U.S. Provisional Patent Application No. 63 / 657,022, filed June 06, 2024, the entire disclosure of which is herein incorporated by reference in its entirety.BACKGROUND

[0002] Orthodontic devices can be used to reposition teeth to avoid clinical difficulties or adjust appearance. The patient can experience certain discomforts as a result, such as aches or pain in teeth or in soft tissues of the mouth.SUMMARY

[0003] According to an embodiment, a guard is disclosed herein. The guard includes a support arm, a cantilever arm, and a shield. The support arm includes a lumen extending therethrough, the lumen is configured to receive a wire. The cantilever arm extends at least distally from the support arm and the cantilever arm is configured to pivot about a pivot point. The shield is affixed to the cantilever arm and the shield is configured to cover a distal end of the wire.

[0004] In an embodiment the guard can be formed from an elastomer. The guard can be integrally formed. The lumen can extend through a proximal face of the support arm and through a distal face of the support arm. In some embodiments, the guard can include a slit extending through and along a face of the support arm. The slit can either be a straight line or a spline.

[0005] In an embodiment the pivot point can be a living hinge, and the cantilever arm can be configured to pivot about the living hinge away from the support arm. The shield can extend along a curve. The curve can extend generally distally away from the cantilever arm and towards the support arm. The shield extends along a straight line. The support arm can further include at least two anti-rotation supports. The anti-rotation supports can extend perpendicular to the support arm and can be configured to prevent rotation of the guard about the wire.

[0006] According to an embodiment, a method is disclosed. The method includes, inserting a wire into a lumen of a support arm; displacing a guard including a cantilever arm extendingfrom a pivot point on the support arm; and pivoting the cantilever arm to position a shield, on the cantilever arm, over a distal end of the wire.

[0007] In an embodiment, the wire can be an orthodontic wire arranged in a patient's mouth. The method can further include arranging the cantilever arm over a rear-most bracket affixed to a tooth of the patient such that the distal end of the wire is prevented from contacting soft tissue of the patient. The inserting step can include threading the wire into a proximal insertion hole of the lumen. The inserting step can include sliding the wire through a slit extending along the support arm and into the lumen. The slit can be one of a straight line or a spline.

[0008] In an embodiment, the method can include displacing the cantilever arm and shield to provide access to the wire after the inserting step. The support arm can include at least two anti-rotation supports being configured to prevent rotation of the guard about the wire. The shield can extend along a curve. The curve can extend generally distally away from the cantilever arm and towards the support arm. The shield can extend along a straight line. The guard can be formed from an elastomer. The guard can be an integral construction.

[0009] In an embodiment, a guard is disclosed herein. The guard includes a support arm, a cantilever arm, and a retaining arm. The support arm includes a groove configured to receive a wire and a through hole. The cantilever arm extends at least distally from the support arm and is configured to pivot about a pivot point. The retaining arm is flexible and configured to wrap around the wire. The retaining arm includes one of a loop, tab, or a ring which can be passed through the through hole and locked therein.

[0010] In an embodiment the guard can be formed from an elastomer. The guard can be integrally formed. The retaining arm can be separate from the support arm.

[0011] It should be appreciated that the foregoing concepts, and additional concepts discussed below, may be arranged in any suitable combination, as the present disclosure is not limited in this respect. Further, other advantages and novel features of the present disclosure will become apparent from the following detailed description of various non-limiting embodiments when considered in conjunction with the accompanying figures.BRIEF DESCRIPTION OF DRAWINGS

[0012] Non-limiting embodiments will be described by way of example with reference to the accompanying figures, which are schematic and are not intended to be drawn to scale. In the figures, each identical or nearly identical component illustrated is typically represented by a single numeral. For purposes of clarity, not every component is labeled in every figure, nor is every component of each embodiment shown where illustration is not necessary to allow those of ordinary skill in the art to understand the disclosure. In the figures:

[0013] FIG. 1 is a side, elevation, view of orthodontics installed in the mouth of a patient;

[0014] FIG. 2 is a schematic, perspective, view of orthodontics installed in the mouth of a patient;

[0015] FIG. 3 is a side, elevation, view of wax installed on orthodontics;

[0016] FIG. 4 is a front perspective view of a wire guard according to an embodiment;

[0017] FIG. 5 A is a rear perspective view of the wire guard of FIG. 4;

[0018] FIG. 5B is a front perspective view of the wire guard of FIG. 4;

[0019] FIG. 5C is a top perspective view of the wire guard of FIG. 4;

[0020] FIG. 5D is a front, elevation, view of the wire guard of FIG. 4

[0021] FIGs. 6A, 6B, 6C, 6D, and 6E illustrate a method of use of the wire guard of FIG. 4 according to an embodiment;

[0022] FIGs. 7A, 7B, 7C, and 7D are views of the wire guard of FIG. 4 installed according to an embodiment;

[0023] FIG. 8 A is a rear view of a wire guard according to an embodiment;

[0024] FIG. 8B is a proximal view of the wire guard of FIG. 8 A;

[0025] FIG. 8C is a side view of the wire guard of FIG. 8A;

[0026] FIG. 9 is a side view of a wire guard according to an embodiment;

[0027] FIGs. 10A, 10B, and 10C illustrate a wire guard according to an embodiment;

[0028] FIGs. 11 A and 1 IB illustrate a wire guard according to an embodiment;

[0029] FIGs, 11C, 11D, HE, HF, 11G, and 11H illustrate a wire guard according to an embodiment;

[0030] FIG. 12 is a perspective view of a wire guard according to an embodiment;

[0031] FIGs. 13A, 13B, 13C, and 13D illustrate a method of use of the wire guard of FIG. 12 according to an embodiment;

[0032] FIGs. 14A and 14B are various view of a wire guard according to an embodiment;

[0033] FIG. 15 is a perspective view of a wire guard according to an embodiment;

[0034] FIGs. 16A, 16B, and 16C illustrate a method of use of the wire guard of FIG. 15 according to an embodiment;

[0035] FIG. 17 is a perspective view of a wire guard according to an embodiment;

[0036] FIGs. 18A, 18B, 18C, 18D, 18E, 18F, 18G, 18H, and 181 illustrate a method of use of the wire guard of FIG. 17 according to an embodiment;

[0037] FIGs. 19A, 19B, 19C, 19D, 19E, 19F, and 19G illustrate various views of a wire guard according to an embodiment;

[0038] FIGs. 19H, 191, 19J, and 19K illustrate a method of use of the wireguard of FIGs. 19A - 19G; and

[0039] FIGs. 20A, 20B, 20C, 20D, 20E, 20F, and 20G illustrate various views of a wire guard according to an embodiment.DETAILED DESCRIPTION

[0040] Some conventional orthodontic devices include an orthodontic wire connecting a series of orthodontic brackets affixed to the teeth, as shown in FIGs. 1 and 2. Orthodontics, such as braces, can often introduce discomfort in patients. Patients will often experience pain, or discomfort, as their teeth are slowly shifted into preferred arrangements. The process often includes the application of a plurality of brackets 120 onto the teeth 110, then connecting the plurality of brackets 120 with a wire 100, as seen in FIGs. 1 and 2. The wire 100 necessarily needs to extend distal to the rear-most bracket 122, such that the distal end of the wire 102 will be unfixed, to allow the clinically necessary sliding of the brackets 122 relative to one another. In some cases, where the wire 100 extends past the rear-most orthodontic brackets 122 and risks “wire poke.” “Wire poke” refers to the discomfort created when an orthodontic wire extends beyond the last-most orthodontic bracket in a patient’s mouth and the wire then causes irritation to the proximate tissues, such as the patient’s cheek. The problem of wire poke impacts a large number of patients and persists even after decades of work on orthodontics and great investments in addressing it.

[0041] For example, the problem cannot be remedied by placing the distal end 102 of the wire 100 within a conventional orthodontic bracket 122, as seen in FIGs. 1 and 2. Per conventionaldesign, a small part of the wire 100 extends beyond the last bracket 122 because otherwise, the wire 100 could become stuck in the bracket lumen, a circumstance known as “binding.” Binding of the wire, rather than free sliding of the wire, can undermine proper functioning of the orthodontics and prevent tooth movement. Because orthodontic wire 100 is designed to slide within the brackets 120, 122, wire poke cannot be avoided by shortening the wire 100, as a shortened wire could move within the brackets 120, 122 such that more of the wire becomes exposed and pokes the patient’s tissues, regardless.

[0042] Some orthodontists may attempt to crimp the wire 100 or otherwise adjust a shape of the wire 100 to prevent excessive sliding, in the hopes that a wire that is well-positioned at an appointment and has low risk of wire poke will not slide into a configuration with a higher risk of wire poke. For example, orthodontists may attempt to bend an end of the wire to avoid the tip poking, but the rounded distal tip of the wire can still come into contact with soft tissue in the oral cavity and still cause poke and irritation. For example, this approach still risks the patient’s tissues (e.g., the inside of the cheek) coming into contact with the crimp or other shape, which may be another source of tissue irritation even without wire poke. In addition, bending the wire just behind the most distal bracket carries a high risk of accidental dislodgement of the bracket from the tooth. If the bracket becomes dislodged, it is greatly inconvenient for the clinical operations of the practice as it requires significant chair-side time to repair. Dislodgement of the bracket can also lengthen the time spent in treatment by several months, which is a burden to both the patient and the orthodontist. Another strategy the orthodontist may employ is to cut the wire as close as possible to the point where the wire exits the lumen of the bracket. However, this technique also carries a high risk of bracket dislodgement, with associated burdens as described above. While reference is made to “wire poke,” it is noted that patients may additionally suffer from pain or discomfort when the soft tissue in the oral cavity rubs against any of the brackets 120 that form part of the orthodontic devices.

[0043] In the absence of other relief, some patients may apply of a blob, or piece, of wax 130, or other gel-like substances, to the distal end 102 of the wire 100 and hope the wax 130 provides relief, as shown in FIG. 3. In some cases, the blob of wax can be disposed over the rear most bracket 122 and rear most tooth 112. However, the wax 130 tends to fall off quickly. Other solutions encompass long strips of material which adhere to the brackets orwire by a variety of mechanical retentive components. These long strips of material are bulky and not practical for day-to-day life, covering as they do, large areas within the mouth, and as such, are unsightly, cannot be worn while eating or cleaning the teeth, and will interfere with speech.

[0044] Some patients may also seek to slide the wire 100 away from their tissue, such as by pushing an end of the wire away from cheek using, for example, a pencil eraser. This technique has low success with most wires as the wires 100 are often either too stiff to be moved or springs back once bent. Some patients even attempt to trim the wire 100 using wire cutters to seek relief from wire poke, but due to lack of patient skill in dental arts and non- orthodontic grade instrumentation, this patient action can risk dislodgement of the distal bracket 122, trauma to the tissues, and even inhalation or swallowing of parts which are detached in an uncontrolled manner.

[0045] Described herein are examples of methods and apparatuses to address wire poke to prevent the distal end of the wire 102 from coming into contact with the soft tissue in the oral cavity. The instant apparatuses, and associated methods of use, can include a guard 200, e.g., a wire guard, that can include a support arm 210, otherwise referred to as a “hollow tube” herein, which can be affixed to the wire 100. The support arm 210 can include a lumen 212 which can receive the wire 100. The guard 200 can include a cantilever arm 220 which can be pivotally connected to the support arm 210, such that the cantilever arm can pivot relative to the support arm 210. Affixed to the cantilever arm 220 can be a shield 230 that can be shaped and sized to cover the distal end 102 of the wire to address wire poke.

[0046] Described below are illustrative embodiments of such an apparatus for reducing the risk of orthodonture discomfort, such as by reducing the risk of wire poke. It should be appreciated, however, that these are merely examples of embodiment of techniques described herein. Other embodiments are possible. For example, as shown in at least FIGs. 11C-11H, a wire guard 3200 can be disposed on any bracket, e.g., bracket 120, to cover the bracket 120 within the brace system. In some cases, in addition to, or alternative to, the wire poke, the brackets 120 can cause irritation within the patient’s mouth. As such, the various wire guards disclosed herein can additionally protect the patient’s oral soft tissue from irritation caused by other brackets 120 within the brace system.

[0047] In an embodiment, for example as shown in FIG. 4, a wire guard 200 can be provided that can include a hollow tube 210, or support arm, affixed to the wire 100. The hollow tube 210 can, in an embodiment, include a cantilever arm 220 pivotally affixed to the hollow tube. The cantilever arm 220 can pivot, about a pivot point 222, to allow a shield 230 to be positioned over the distal end of the wire 102. The shield 230 can therefor protect the patient’s soft tissue to prevent irritation or injury. In some embodiments the wire guard 200 can include at least one stabilizer, e.g., a support arm, anti-rotation support, or a wing, 240, fixed to the hollow tube 210, that can prevent the wire guard 200 from rotating about the wire 100 by acting as stabilizers which can extend at least partially perpendicular to the to the hollow tube 210. The wings 240 can abut the patient’s tooth or gums to prevent the wire guard 200 from rotating about the wire 100 arranged within the lumen 212.

[0048] In an embodiment, the wire guard 200 can be formed from any biocompatible material. For example, the wire guard 200 can be formed from a biocompatible plastic, e.g., polyethylene or other elastomers, from a metal, or other biocompatible materials. In an embodiment, the wire guard 200 can be manufactured by additive manufacturing methods such as 3D printing, injection molding, subtractive manufacturing processes, or combinations thereof. In an embodiment the wire guard 200 is an integral construction such that the hollow tube 210, the cantilever arm 220, the shield 230, and wing 240 can be all a single piece of material. Alternatively, each part of the wire guard 200 can be manufactured separately and affixed together using known mechanical or chemical connection means.

[0049] With reference to FIGs. 4, 5A, 5B, 5C, and 5D, a wire guard 200 according to an embodiment is shown. The wire guard 200 can, in an embodiment, be affixed to orthodontic structures via a hollow tube 210. In an embodiment, the hollow tube 210 can be rigid to provide the wire guard 200 with structural support, or the hollow tube 210 can be flexible to allow the hollow tube 210 to conform to the shape of the orthodontic structure. In an embodiment, the hollow tube 210 can be a generally elongated structure having any cross-sectional shape. As illustrated in FIG. 4, an exterior shape of the hollow tube 210 can have a square cross-section, however, the hollow tube 210 can have a circular, triangular or any regular or irregular polygonal cross-section. Extending through the hollow tube 210 can be a lumen 212. The lumen 212 can extend through a proximal face214a of the hollow tube through to a distal face 214b of the hollow tube 210 to create a through hole. The lumen 212 can define an interior shape having a square cross-section, as illustrated in at least FIG. 4. Alternatively the lumen can define an interior shape having any cross-section which may, or may not, match the exterior cross-section of the hollow tube 210. The lumen 212 can be sized to receive the orthodontic structure, e.g., the wire 100. In an embodiment, the lumen 212 can be a central lumen such that the lumen 212 is coaxial with a central axis of the hollow tube 210.

[0050] In an embodiment, the hollow tube 210 can have a plurality of wings 240, or a single wing 240, to aid in preventing the wire guard 200 from rotating about the orthodontic structure, e.g., the wire 100. The wings 240 can function as stabilizers, or stabilizer arms, which can extend perpendicular to the wire 100. The wings 240 can abut the patient’s tooth 112 or gums to prevent the wire guard 200 from rotating about the wire 100 arranged in the lumen 212. In some embodiments, as illustrated in the figures, the wing 240 can have a generally curved wedge shape, meaning the wedge face can be a curved surface where the remaining sides are all flat. Alternatively, the wedge could be cylindrical, rectangular, cubic, pyramidal, or other shapes. In an embodiment, the wire shield can include two wings 240 on opposite sides of the hollow tube 210. Alternatively, only one wing 240 may be used. In an embodiment, a first wing 240 can extend from a top surface 216a of the hollow tube 210 and a second wing 240 can extend from a bottom surface 216b of the hollow tube 210. In an embodiment, the wings 240 can extend such that they define a height that is approximately the height of the rear most molar tooth 112 such that the wings do not extend into the gum line or above the occlusal plane, or bite plane. Alternatively, the wings 240 can be any height up to the height of the rear most molar tooth 112.

[0051] In an embodiment, the hollow tube 210 can include a cantilever arm 220 extending distally from a pivot point 222. The cantilever arm 220 can be a generally elongated bar that can pivot about the pivot point 222 to allow the cantilever arm 220 to be moved out of the way for cleaning or other medical needs. The length of the cantilever arm 220 can be based on the length of the tooth 110 or the bracket 120 over which it extends. While the cantilever arm 220 is illustrated having a rectangular cross-section, the cantilever arm can have a square, circular, triangular, or other cross-sectional shape. The pivot point 222 can, in an embodiment, be a living hinge, or resilient hinge, that elastically deforms to allow thecantilever arm 220 to pivot about axis A. In some embodiments, the cantilever arm 220 can pivot about other axis, as needed. Alternatively, the pivot point 222 can be any suitable hinge or structure that allows the cantilever arm 220 to pivot relative to the hollow tube 210. In some embodiments, the hollow tube 210, cantilever arm 220, and wings 240 can be rigid to prevent bending when external forces, e.g., an orthodontist’s tool, toothbrush, etc., are applied, whereas the pivot point 222 can be flexible to permit relative pivoting between the cantilever arm 220 and the hollow tube 210.

[0052] As shown in FIGs. 4 and 5A-D, a shield 230 can extend distal from the cantilever arm 220. The shield 230 can extend along an arc distally and towards the gums of the patient. The shield 230 can extend distally and towards the gums along any line shape, e.g., in an “L” shape, or a line having multiple angles such that the shield can cover the distal end 102 of the wire 100. The shield can extend towards the gum line to capture the wire 100 and prevent unwanted contact between oral tissue and the wire 100 from a number of likely directions. In an embodiment, the shield 230 can be wider than the cantilever arm 220. Alternatively, the shield can have any suitable dimensions.

[0053] The instant wire guards can be installed during the installation of orthodontic wire or after. While the method is described with reference to a single wire guard 200 on a single wire 100, it is understood that the method may be repeated until all distal ends 102 of the wire 100, or wires, have wire guards 200 installed thereon. In some embodiments, only one wire guard 200 may be installed; alternatively, two, three, four, or more may be installed on a wire 100, depending on the specific needs of the patient. For example, in the case where the wire guard is being installed on already installed orthodontics, the orthodontist can remove the wire 100 from the rear most bracket 122. Alternatively, if the orthodontics are being installed, then there may be no need to remove the wire 100 from the rear most bracket 122. Once the wire is free, an orthodontist can slide the wire 100 onto the hollow tube 210, e.g., within the lumen 212, as shown in FIG. 6 A. As the wire guard 200 is being slid onto the wire 100, the cantilever arm 220 can flex out of the way of the wire 100 about the pivot point 222, as shown in FIG. 6B. The orthodontist can slide the wire 100 through the rear most bracket 122, per accepted practices. Once the wire 100 has been secured, as shown in FIG. 6C, the orthodontist can slide the hollow tube 210 of the wire guard 200 distally along the wire 100 towards the rear-most bracket 122, as shown in FIG. 6D. Thecantilever arm 220 can flex back to a neutral position once the wire guard 200 is positioned correctly to allow the shield 230 to cover the distal end 102 of the wire 100 to prevent the wire from interacting with the soft tissue, as shown in FIG. 6E and FIGs. 7A, 7B, 7C, and 7D. This method can be repeated for each of the four rear-most brackets 122 arranged in the patient. Alternatively, the wire guard 200 can be installed only on those areas where wire-poke is an issue.

[0054] Once the wire guard 200 has been installed, the cantilever arm 220 can allow for cleaning or maintenance of the orthodontic structures beneath by pivoting the cantilever arm 220 away from the wire 100 and rear most bracket 122 to perform the necessary actions. Once the necessary actions, e.g., cleaning, is complete the cantilever arm 220 can flex back to a neutral position once the wire guard 200 is positioned correctly to allow the shield 230 to cover the distal end 102 of the wire 100 to prevent the wire from interacting with the soft tissue. While mention of an orthodontist is used as the primary actor in this method, it is contemplated that any medical professional or assistant, or the patient themselves, can perform this method in accordance with this disclosure.

[0055] In an embodiment, as shown in FIGs. 8A, 8B, and 8C, an alternative wire guard 1200 is shown. For the sake of brevity, only the hollow tube 1210 will be discussed, all other structures can be substantially the same as those described above. In some cases, it may not be easy, or practical to remove the wire 100 from the rear most bracket 122. Thus, the wire guard 1200 of FIGs. 8A-C, can be pushed onto the wire 100 by means of a slit 1240 that extends through a rear face 1218a of the hollow tube 1210. The slit 1240 can extend along any suitable path, for example, as shown in FIGs. 8A-C, the slit 1240 can be a spline having a generally sinusoidal shape. Alternatively, the slit 1240 can extend along a straight line, a zigzag, or other linear or curved path. In an embodiment, the slit 1240 can include ridges 1242, 1244 which extend outward from the rear face 1218a and can provide tactile feedback for the user to “feel” the wire 100 and define an insertion path for the wire 100. The slit 1240 can extend inward from the rear face 1218a towards the front face 1218b of the hollow tube 1210 to create a locking channel 1250. The locking channel 1250 can extend from the lumen 1212 to the slit 1240 to prevent the wire 100 from backing out of the slit 1240. In an embodiment, the locking channel 1250 can have a generally “L” cross- sectional shape with the base 1252 of the “L” extending below the lumen 1212, as shownin at least FIG. 8B. The slit 1240 and locking channel 1250 can allow for the wire guard 1200 to be pushed onto the wire 100 without the need for the wire 100 to be removed from a rear-most bracket 122. Such an arrangement can allow a patient to install the wire guard 1200 onto the wire 100 themselves in the event that irritation to their soft tissue occurs after a visit to the orthodontist, or they need to perform a deeper cleaning. In an embodiment, the distal face 1214b of the hollow tube 1210 can be generally flat, as seen in FIG. 8C. In an alternative embodiment, as shown in FIG. 9, the distal face 1214b of the hollow tube 1210 can be contoured to generally match the surface contour of the rear-most tooth 112 to allow the wire guard 1200 to be pushed closer to the rear- most tooth 112. While the contoured distal face 1214b is shown with respect to the wire guard 1200, it is contemplated that such contouring can be used with the wire guard 200 of other embodiments, with or without a slit 1240.

[0056] In an embodiment, as shown in FIGs. 10A, 10B, and 10C, an alternative wire guard 2200 is shown. For the sake of brevity, only the cantilever arm 2220 will be discussed, all other structures can be substantially the same as those described above, unless otherwise noted. For example, in the embodiment of FIGs. 10A and 10B, the hollow tube 2210, also referred to as a support arm, may not include the stabilizers, or wings, that are shown in the wire guard 200 of FIG. 4. However, it is contemplated that the wire guard 2200 may include such stabilizers or wings. In an embodiment, as shown in FIG. 10A, the cantilever arm 2220 can have a height H. The height H can additionally aid in stabilization of the wire guard 2200. In some embodiments, the wire guard 2200 can have a constant height H along its entire length. For example, the height H can be approximately large enough to cover the rear most bracket 2122 to prevent additional irritation from the bracket 2122 against any soft tissue in the oral cavity. At the distal end of the cantilever arm 2220 a curved shield 2230 can extend distally and toward the gum line, to cover the distal end of the wire 2102.

[0057] In an embodiment, as shown in FIGs. 11A and 11B, an alternative wire guard 3200 is shown. For the sake of brevity, unless otherwise noted all other structure can be substantially the same as those described above in any of wire guard 200, wire guard 1200, or wire guard 2200. For example, in the embodiment of FIGs. 11 A and 1 IB, the hollow tube 3210, also referred to as a support arm, may not include the stabilizers, or wings, thatare shown in the wire guard 200 of FIG. 4. However, it is contemplated that the wire guard 3200 may include such stabilizers or wings. In an embodiment, as shown in FIG. 11 A, the wire guard 3200 can have a consistent height along its entire length. For example, the height H can be approximately large enough to cover a bracket 3120 to prevent additional irritation from the bracket 3120 against any soft tissue in the oral cavity. Alternatively, the height H can vary along the length of the wire guard 3200. The cantilever arm 3220 can extend along the length of the bracket 3120. In an embodiment, the distal end of the cantilever arm 3220 can include a linear shield 3230 which can extend to cover an additional portion of the wire 3100. In an embodiment, the linear shield 3230 can extend along a straight, or substantially straight, line. For example, the linear shield 3230 can extend in-line with the cantilever arm 3220 such that the wire guard 3200 can be disposed over any bracket 3120 in the orthodontic system - not only the distal most bracket. For example, the wire guard 3200 can be arranged between any two of the plurality of brackets which make up the orthodontic system to prevent parts of a bracket from poking soft tissue in the oral cavity. Alternatively, in place of a linear shield 3230, the cantilever arm 3220 can be extended.

[0058] In an embodiment, as shown in FIGs. 11C, 11D, HE, HF, 11G, and 11G, an alternative wire guard 3200 is shown. For the sake of brevity, unless otherwise noted all other structure can be substantially the same as those described above in any of wire guard 200, wire guard 1200, or wire guard 2200. For example, as shown in FIGs. 11C and HD, the hollow tube 3210, also referred to as a support arm, may not include the stabilizers, or wings, that are shown in the wire guard 200 of FIG. 4. However, it is contemplated that the wire guard 3200 may include such stabilizers or wings. In an embodiment, as shown in FIGs. HE and HF, the wire guard 3200 can have a consistent height along its entire length. For example, the height H can be approximately large enough to cover a bracket 3120 to prevent additional irritation from the bracket 3120 against any soft tissue in the oral cavity. In an embodiment, the height H can be approximately large enough to cover any bracket within the system. Alternatively, the height H can vary along the length of the wire guard 3200. The cantilever arm 3220 can extend along the length of the bracket 3120. In an embodiment, the distal end of the cantilever arm 3220 can include a linear shield 3230 which can extend to cover an additional portion of the wire 3100. In an embodiment,the linear shield 3230 can extend along a straight, or substantially straight, line. For example, the linear shield 3230 can extend in-line with the cantilever arm 3220 such that the wire guard 3200 can be disposed over any bracket 3120 in the orthodontic system - not only the distal most bracket. For example, the wire guard 3200 can be arranged between any two of the plurality of brackets which make up the orthodontic system to prevent parts of a bracket from poking soft tissue in the oral cavity. Alternatively, in place of a linear shield 3230, the cantilever arm 3220 can be extended.

[0059] In some embodiments, wire guard 3200 can include a base portion 3210. The base portion 3210 can include a distal facing slit 3240 for receiving a wire 3100, for example the wire 3100 shown in FIG. 11 A. In some embodiments, the wire 3100 can be retained within the slit 3240 as the slit 3240 can be more narrow than the diameter of the wire 3100 to prevent the wire guard 3200 being removed from the wire 3100. In some embodiments, the base portion 3210 can include a top through hole 3212 and a bottom through hole 3214. The top through hole 3212 and the bottom through hole 3234 can be sized to receive a length of a thread, not shown, to retain the wire guard 3200 against the wire 3100. For completeness sake, a bottom view of wire guard 3200 is shown in FIG. 1 IE, a top view is shown in FIG. 1 IF, a front side view is shown in FIG. 11G, and a side view is shown in FIG. 11H.

[0060] In some embodiments, as shown in FIG. 12, a wire guard 4200 is provided. For the sake of brevity, unless otherwise noted all other structure can be substantially the same as those described above in any of wire guard 200, wire guard 1200, wire guard 2200, or wire guard 3200. In some embodiments, in place of a hollow tube, the wire guard 4200 can include a support 4210. The support 4210 can be substantially the same as the hollow tube described with respect to other embodiments. In an embodiment, in place of the central lumen, the support 4210 can include a groove 4212 to receive the wire 4100. The groove 4212 can be open such that the wire guard 4200 can be placed over the wire 4100 and the wire 4100 can be arranged within the groove 4212. The groove 4212 may not retain, hold, or otherwise restrict movement of the wire. To retain the wire guard 4200 to the wire 4100, the device can include a retaining arm 4250 which can be arranged around the wire 4100 to lock the wire guard 4200 to the wire 4100. The retaining arm 4250 can extend from a bottom surface 4216b of the support 4210. The retaining arm 4250 can terminate in a loop4252. In some embodiments, the loop 4252 can include a through hole 4254 which can be sized to allow a length of floss 4260 to be retained thereon, for example with a knot as shown in FIG. 13 A. The loop 4252 can be compliant such that its shape can be altered. While reference is made to the use of floss 4260, it should be appreciated that any material can be used. In an embodiment, the retaining arm 4250 can be pivotally attached to the support 4210. In some embodiments, the retaining arm 4250 can be flexible such that it can be wrapped around the wire 4100. In some embodiments, a wing 4240 can extend from a top surface 4216a of the support 4210. The wing 4240 can function similarly to the wing described with respect to the other embodiments. In some embodiments, the wing 4240 can include a through hole 4242 which can receive the loop 4252 to retain the wire guard 4200 to the wire 4100. The through hole 4242 can be sized to be smaller than the loop 4252 when the loop is in a relaxed, or uncompressed, state.

[0061] In a method of use, as shown in FIGs. 13 A - 13D, the wire guard 4200 can be retained onto the wire 4100 without the need to remove the wire 4100 from the bracket 4120. In an embodiment, floss 4260 can be tied, or otherwise retained, onto the loop 4252 of the retaining arm 4250. A distal end 4262 of the floss 4260 can be threaded between the wire 4100 and the tooth 4110, as shown in FIG. 13 A. The distal end of the floss 4260 can then be threaded into the through hole 4242 of the wing 4240 and pulled therethrough, as shown in FIG. 13B. In some cases, the distal end of the floss 4260 can be threaded into the through hole 4242 while the wire guard 4200 is disposed outside of the mouth of the patient such that the patient can see the device. In some embodiments, the user can then pull the floss 4260 such that the loop 4252 can be compressed to fit through the through hole 4242, as seen in FIG. 13C. Once the loop 4252 has been fully drawn through the through hole 4242, the loop 4252 can regain its relaxed state, as shown in FIG. 13D. The loop 4252 can temporarily lock the retaining arm 4250 around the wire 4100. The user can unknot or cut the floss 4260 off the loop 4252 once the installation is complete.

[0062] In an embodiment, as shown in FIGs. 14A and 14B, an alternative wire guard 5200 is provided. Wire guard 5200 is substantially the same as the wire guard 4200. However, the loop 4252 of the retaining arm 4250 can be replaced with a tab 5252 and a flexible threader 5254 can be provided. The threader 5254 can be used in place of the floss 4260 and can be cut off and disposed of after the wire guard 5200 is installed in the oral cavity.

[0063] In some embodiments, as shown in FIG. 15, a wire guard 6200 is provided. The wire guard 6200 can be substantially the same as the wire guard 5200. However, in place of a cantilever arm and shield, a single protective pad 6220 can extend from a pivot point 6222. The pivot point 6222 can be attached to a support, or as illustrated in FIG. 15, the pivot point 6222 can be a compliant hinge extending from a retaining through hole 6242. The retaining through hole 6242 can be substantially the same as the through hole 4242. A loop tab 6252 can extend from the retaining through hole 6242 perpendicular to the pivot 6222. The loop tab 6252 can, similar to loop 4252, be disposed about a wire 6100 and inserted through the retaining through hole 6242.

[0064] In a method of use, as shown in FIGS. 16A, 16B, and 16C, the wire guard 6200 can be installed over a bracket 6120 without the need to remove the wire 6100 from the bracket 6120. The method shown in FIGS. 16A-C can be substantially the same as the method shown in FIGS. 13A-D. For example, a length of floss 6260 can be attached through the loop 6252 can threaded behind a portion of the wire 6100, as shown in FIG. 16A. The distal end of the wire 6100 can then be threaded into the through hole 6242. The length of floss 6260 can be pulled through the through hole 6242 until the loop 6252 compresses and slides through the through hole 6242, as shown in FIG. 16B and 16C. The wire guard 6200 can use the cheek to keep the single protective pad 6222 in position over the bracket 6120 to protect the cheek from the wire 6100. In some embodiments, the surface area of the protective pad 6220 can be larger to account for movement of the protective pad relative 6220 to the bracket 6120.

[0065] In an embodiment, as shown in FIG. 17, a wire guard 7200 is provided. For the sake of brevity, unless otherwise noted all other structure can be substantially the same as those described above in any of wire guard 200, wire guard 1200, wire guard 2200, wire guard 3200, wire guard 4200, wire guard 5200, or wire guard 6200. Wire guard 7200 can, generally, be a two piece assembly. The first piece can be a retaining member 7300, also referred to as a retaining arm, and the second portion can form a guard portion 7202. In an embodiment, the retaining member 7300 can be a unitary chain member having a plurality of rings 7302, for example three 7302a, 7302b, 7302c, each connected to one another by a compliant link 7304, or hinge, as shown in FIG. 18 A. The rings 7302 can be compressible such that their outer dimensions can be reduced with the application of a force. The guardportion 7202 can be substantially the same as the wire guard 4200, except that the guard portion 7202 can include a top wing 7240 having a top through hole 7242 and bottom wing 7244 having a bottom through hole 7246. The top through hole 7242 and the bottom through hole 7246 can be sized to receive one, or more, of the rings 7302 of the retaining member 7300, when the rings 7302 are compressed, and the top through hole 7242 and bottom through hole 7246 can be sized to prevent the rings 7302 from being pulled out in a direction opposite of the insertion direction when the rings 7302 are in an uncompressed state.

[0066] In a method of use, as shown in FIGS. 18A - 181, the two piece wire guard 7200 can be installed onto a wire 7100, without the need to remove the wire 7100 from a bracket 7120. The user can take the retaining member 7300 and affix a length of floss 7260, or other string, to one of the rings 7302a, as shown in FIG. 18A. The user can take the floss 7260 and thread the free end through the bottom hole 7246, as shown in FIG. 18B, until the rings 7302a and 7302b are pulled through as shown in FIGS. 18C and 18D, leaving ring 7302c on an opposite side of the bottom wing 7244. The user can thread the floss 7260 between the wire 7100 and the teeth, as shown in FIG. 18E. The user can thread the free end of the floss 7260 through the top hole 7242, either within, or outside of, the patient’s mouth, as shown in FIG. 18F. The user can draw the floss 7260 through the top hole 7242 such that the wire guard 7200 is adjacent to the wire 7100, as shown in FIG. 18G and the ring 7302a is drawn through the top hole 7242, as shown in FIG. 18H - thereby locking the retaining member 7300 to the guard portion 7202, as seen in FIG. 181. The retaining member 7300 can thereby fix the guard portion 7202 about the wire 7100. The floss 7260 can be removed from the ring 7302a, as seen in FIG. 181.

[0067] In an embodiment, as shown in FIGs. 19A - 19K, a wire guard 8200 is provided. For the sake of brevity, unless otherwise noted in some embodiments structures of wire guard 8200 can be substantially the same as those described above in any of wire guard 200, wire guard 1200, wire guard 2200, wire guard 3200, wire guard 4200, wire guard 5200, wire guard 6200, or wire guard 7200, and wire guard 8200 may be implemented with features described above with any of those other illustrates wire guards. Wire guard 8200 can, in some embodiments, be a one piece assembly. For example, the wire guard 8200 can be of a unitary construction made from a single piece of material. The unitary construction ofsome such examples of the wire guard 8200 can be made from a single piece of material having a similar construction to the to the guard portion 2210 from the embodiment shown in FIGS. 10A - 10C.

[0068] In an embodiment, wire guard 8200 can include a cantilever arm 8210, also referred to as a support arm, may not include the stabilizers, or wings, that are shown in the wire guard 200 of FIG. 4. However, it is contemplated that the wire guard 8200 may include such stabilizers or wings. In an embodiment, as shown in FIGS. 19A and 19B, the cantilever arm 8210 can have a height H. The height H can additionally aid in stabilization of the wire guard 8200. In some embodiments, the wire guard 8200 can have a constant height H along its entire length. For example, the height H can be approximately large enough to cover the rear most bracket 8122 to prevent additional irritation from the bracket 2122 against any soft tissue in the oral cavity. At the distal end of the cantilever arm 8220 a curved shield 8230 can extend distally and toward the gum line, to cover the distal end of the wire 8100.

[0069] In some embodiments, wire guard 8200 can include a base portion 8220. The base portion 8220 can include a distal facing slit 8240 for receiving a wire 8100. In some embodiments, the wire 8100 can be retained within the slit 8240 as the slit 8240 can be more narrow than the diameter of the wire 8100 to prevent the wire guard 8200 being removed from the wire 8100. In some embodiments, the base portion 8220 can include a top through hole 8222 and a bottom through hole 8224. The top through hole 8222 and the bottom through hole 8224 can be sized to receive a length of a thread 8260 to retain the wire guard 8200 against the wire 8100. For completeness sake, a top view of wire guard 8200 is shown in FIG. 19C, a bottom view is shown in FIG. 19D, a right side view is shown in FIG. 19E, a front / back view is shown in FIG. 19F, and a left side view is shown in FIG. 19G.

[0070] In a method of use, as shown in FIGS. 19H - 19K, the wire guard 8200 can be installed onto a wire 8100, without the need to remove the wire 8100 from a bracket 8120. The user can take a length of floss 8260, or other string, filament, cord, or fiber, and thread the floss 8260 between the wire 8100 and the teeth, as shown in FIGs. 19H and 191. One end of the floss 8260 is threaded through the through hole 8222 and the other end of the floss 8260 is threaded through the through hole 8224, as shown in FIG. 19J. The wire guard 8200 can now be advanced along the floss 8260 towards the wire 8100, as shown in FIG. 19J. Oncethe wire guard 8200 is against the wire 8100, the wire 8100 can be pushed into the slit 8240 and the suture can be tied or otherwise secured to retain the wire guard 8200 against the wire 8100. For the sake of comfort, the excess floss 8260 can be cut and removed.

[0071] In an alternative embodiment, the height H of a support 9210 can vary along the length of the wire guard 9200, for example as shown in the embodiment illustrated in FIGs. 20A- 20G. For completeness sake, a top view of wire guard 9200 is shown in FIG. 20C, a bottom view is shown in FIG. 20D, a right side view is shown in FIG. 20E, a front / back view is shown in FIG. 20F, and a left side view is shown in FIG. 20G. The wire guard 9200 is otherwise substantially structurally similar to the wire guard 8200 and it is used in substantially the same way as described with respect to the method of use as shown in FIGs. 19H - 19K. Although the device is shown and described for use with braces, the device may be used to in a number of other medical applications where portions of an implant may irritate soft tissue of the patient. For example, in the case of bone screws, it may can be beneficial to install the wire guard over the bone screw to prevent any soft tissue from being irritated by the proximal end of the screw.

[0072] As will be further appreciated, although the device is described as being used prior to a surgical procedure, it will be appreciated that the device may be used during a surgical procedure in some embodiments.

[0073] Various aspects of the present disclosure may be used alone, in combination, or in a variety of arrangements not specifically discussed in the embodiments described in the foregoing and is therefore not limited in its application to the details and arrangement of components set forth in the foregoing description or illustrated in the drawings. For example, aspects described in one embodiment may be combined in any manner with aspects described in other embodiments.

[0074] The acts performed as part of the methods may be ordered in any suitable way. Accordingly, embodiments may be constructed in which acts are performed in an order different than illustrated, which may include performing some acts simultaneously, even though shown as sequential acts in illustrative embodiments.

[0075] Use of ordinal terms such as “first,” “second,” “third,” etc., in the claims to modify a claim element does not by itself connote any priority, precedence, or order of one claim element over another or the temporal order in which acts of a method are performed, but are usedmerely as labels to distinguish one claim element having a certain name from another element having a same name (but for use of the ordinal term) to distinguish the claim elements.

[0076] Also, the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” or “having,”“containing,” “involving,” and variations thereof herein, is meant to encompass the items listed thereafter and equivalents thereof as well as additional items.

Claims

CLAIMSWhat is claimed is:

1. A guard, the guard comprising, a support arm having a lumen extending therethrough, the lumen configured to receive a wire; a cantilever arm extending at least distally from the support arm, the cantilever arm configured to pivot about a pivot point; and a shield affixed to the cantilever arm, the shield being configured to cover at least one of a distal end of the wire or a bracket.

2. The guard of claim 1, wherein the guard is formed from an elastomer.

3. The guard of claim 1, wherein the guard is integrally formed.

4. The guard of claim 1, wherein the lumen extends through a proximal face of the support arm and through a distal face of the support arm.

5. The guard of claim 1, further comprising a slit extending through and along a face of the support arm.

6. The guard of claim 5, wherein the slit is either a straight line or a spline.

7. The guard of claim 1, wherein the pivot point is a living hinge, and the cantilever arm is configured to pivot about the living hinge away from the support arm.

8. The guard of claim 1, wherein the shield extends along a curve.

9. The guard of claim 8, wherein the curve extends generally distally away from the cantilever arm and towards the support arm.

10. The guard of claim 1, wherein the shield extends along a straight line.

11. The guard of claim 1, wherein the support arm further comprises at least two anti-rotation supports, the at least two anti-rotation supports extending perpendicular to the support arm and being configured to prevent rotation of the guard about the wire.

12. A method comprising, inserting a wire into a lumen of a support arm; displacing a guard including a cantilever arm extending from a pivot point on the support arm; and pivoting the cantilever arm to position a shield, on the cantilever arm, over at least one of a distal end of the wire or a bracket.

13. The method of claim 12, wherein the wire is an orthodontic wire arranged in a patient’s mouth and the bracket is an orthodontic bracket in the patient’s mouth.

14. The method of claim 13, further comprising, arranging the cantilever arm over a rear-most bracket affixed to a tooth of the patient such that the distal end of the wire is prevented from contacting soft tissue of the patient.

15. The method of claim 12, wherein the inserting step includes threading the wire into a proximal insertion hole of the lumen.

16. The method of claim 12, wherein the inserting step includes sliding the wire through a slit extending along the support arm and into the lumen.

17. The method of claim 16, wherein the slit is one of a straight line or a spline.

18. The method of claim 12 further comprising, displacing the cantilever arm and shield to provide access to the wire after the inserting step.

19. The method of claim 12, wherein the support arm further includes at least two antirotation supports being configured to prevent rotation of the guard about the wire.

20. The method of claim 12, wherein the shield extends along a curve.

21. The method of claim 20, wherein the curve extends generally distally away from the cantilever arm and towards the support arm.

22. The method of claim 12, wherein the shield extends along a straight line.

23. The method of claim 12, wherein the guard is formed from an elastomer.

24. The method of claim 12, wherein the guard is an integral construction.

25. A guard, the guard comprising, a support arm having a groove configured to receive a wire and a through hole; a cantilever arm extending at least distally from the support arm, the cantilever arm configured to pivot about a pivot point; and a retaining arm being flexible and configured to wrap around the wire, the retaining arm including one of a loop, tab, a ring, or a length of floss which can be passed through the through hole and locked therein.

26. The guard of claim 25, wherein the guard is formed from an elastomer.

27. The guard of claim 25, wherein the guard is integrally formed.

28. The guard of claim 25, wherein the retaining arm is separate from the support arm.

29. The guard of claim 28, wherein the support arm further includes a second through hole.

30. The guard of claim 29, wherein the retaining arm is the length of floss; and wherein a first end of the length of floss is secured to the through hole and a second end of the length of floss is secured to the second through hole.

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