WO2020264301A1 - Dental fixation device for mandible immobilization - Google Patents

Abstract

Devices and methods for intermaxillary fixation are disclosed. Devices comprise a plurality of dental bands, positioned around a tooth or teeth, a dental clamp affixed to an external face of the dental band, and at least one attachment for connecting two or more dental bands and providing fixation of the maxilla/mandible complex. The intermaxillary fixation devices can be easily applied to a tooth or a plurality of teeth, and do not require attachment to the gums and/or penetration into bone.

Description

DENTAL FIXATION DEVICE FOR MANDIBLE IMMOBILIZATION

CROSS REFERENCE TO RELATED APPLICATIONS

[1] This application claims benefit under 35 U.S.C. §119(e) of Provisional U.S. patent application no. 62/868,157, filed June 28, 2019, the contents of which are incorporated herein by reference in their entirety.

TECHNICAL FIELD

[2] The disclosure is generally directed to a medical device and methods used for intermaxillary immobilization.

BACKGROUND

[3] Mandible and midface fractures are primarily treated with intermaxillary fixation, which stabilizes and reduces mobilization of the maxillomandibular complex. There are currently two primary types of intermaxillary fixation. The older treatment, which is considered to be the gold standard, uses Erich dental arch bars. In this method, arch bars are attached to the upper and lower gums and stabilize the complex. The newer treatment, which is more popular in many circles, uses maxillo-mandibular fixation screws that are directly inserted into the bone. The increased popularity of fixation screws arises in part from the application surgery taking significantly less time than the arch bar fixation.

[4] Maxillo-mandibular fixation screws are quick and easy to place, but a well- known side effect of screw fixation is bone death, resulting from damage to the root of the tooth by the screw itself. Furthermore, the fixation screws limit the use of tension band adjustments to occlusion. Comparatively, while the arch bars preserve teeth roots, their application is time consuming, tedious, and leaves the surgeon susceptible to penetrating injury of their fingers. The arch bars must also be removed in surgery, which can be very expensive.

SUMMARY

[5] The intermaxillary fixation devices and methods disclosed herein provide non- invasive, efficient means to stabilize a jaw in occlusion. The devices comprise a band that can be applied and fitted around a circumference of a tooth or teeth and secured using a dental clamp. Multiple bands can be linked together through the use of links, e.g., wires, elastic bands, etc. in order to provide intermaxillary fixation.

[6] In embodiments, the dental bands are applied to thickest aspect of a tooth, e.g., the crown of the tooth, and is securely fitted around the tooth’s circumference. The dental clamp can be any of a variety of sizes as to allow for it to be fitted over one, two, three or more teeth at a time at a user’s discretion. The clamp design to secure the band can further comprise any of a plurality of embodiments, including but not limited to a worm gear, hose clamp, hose clip, hose lock, spring clamp, wire clamp, ear clamp. The clamp enables the band to be cinched down to the neck of the tooth, and can have an attached ringlet, hook, or other protrusion on which wires, bands, and other connecting devices can be applied. In this manner, through the linking of multiple fitted bands around teeth, the area of a fracture can be stabilized.

BRIEF DESCRIPTION OF THE DRAWINGS

[7] The foregoing and other features of the present disclosure will become more fully apparent from the following description and appended claims, taken in conjunction with the accompanying drawings. Understanding that these drawings depict only several examples in accordance with the disclosure and are, therefore, not to be considered limiting of its scope, the disclosure will be described with additional specificity and detail through use of the accompanying drawings.

[8] In the drawings:

[9] FIG. 1 illustrates an intermaxillary fixation device in accordance with embodiments disclosed herein.

[10] FIG. 2 illustrates a dental clamp and attachment mechanisms for

intermaxillary fixation devices disclosed herein.

[11] FIG. 3 illustrates intermaxillary fixation devices and dental clamps in accordance with embodiments disclosed herein.

[12] FIG. 4 illustrates an intermaxillary fixation device installed in accordance with methods disclosed herein. DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

[13] In the following detailed description, reference is made to the accompanying drawings, which form a part hereof. In the drawings, similar symbols typically identify similar components, unless context dictates otherwise. The illustrative examples described in the detailed description, drawings, and claims are not meant to be limiting. Other examples may be utilized, and other changes may be made, without departing from the spirit or scope of the subject matter presented here. It will be readily understood that the aspects of the present disclosure, as generally described herein, and illustrated in the Figures, may be arranged, substituted, combined, and designed in a wide variety of different configurations, all of which are explicitly contemplated and make part of the present disclosure.

[14] The present disclosure is generally directed to a medical device and methods for intermaxillary fixation. The devices and methods disclosed herein allow for a non- invasive, easy application to a tooth or a plurality of teeth, and not to a mandible, maxilla, or gums. Compared to conventional treatment and procedures, the devices and methods avoid the risk of killing the tooth and other injuries that can occur from penetrating screw damage. Application, removal, and recovery would all be significantly less painful and significantly more time efficient and cost efficient than the conventional screws or arch bars, since the device is tightened to the tooth and/or teeth and not into bone. Theoretically, the devices could also be applied in the out-patient setting (including an office setting) to save on costs or need for an expensive surgery for the application and removal procedures.

[15] The devices and methods discussed herein further provide doctors and medical professionals the opportunity to quickly apply the intermaxillary fixation device, thus limiting operating room time, saving a significant amount of money, and likely negating the need for surgical application and removal.

[16] Figs. 1-4 illustrate various embodiments of the intermaxillary fixation device disclosed herein. As seen in Fig. 1, the device 100 comprises a dental band 110, a dental clamp 120 provided on an external face of the dental band, and an attachment 140 for a link, such as a wire, a band, or other connecting device to connect two or more dental bands for intermaxillary fixation. [17] The dental band 110 can be slid over the tooth 150 or teeth, for example, at its crown, which is the area of largest circumference. In embodiments, the band can comprise a metal or metal alloy, including but not limited to materials such as gold, platinum, cobalt, palladium, nickel, chromium, or a resin, ceramic, or other material suitable for the applications discussed herein. The dental band 110 can further comprise a flexible material, the stiffness of which may be chosen and dependent upon one or more desired features and the intended application. In an example, the band comprises a flexible material such that when tightened, the band conforms to the shape of the tooth or teeth.

[18] During its application onto a tooth, the dental band can be positioned, e.g., above the gums at the level of the neck and then tightened using a dental clamp 120. The dental clamps disclosed herein can comprise any of a plurality of designs and configurations depending on, e.g., user preference, cost, efficiency of application, tooth size, dental band material, desired tension, and so on. Figs. 1-3 for example, illustrate the dental clamp 120 as a worm drive. In these embodiments, the worm drive comprises a gear or screw, which, when rotated, engages threads on the dental band to tighten the device. Thus, the dental band can further comprise a plurality of threads 130 on its external face. The thread may be cut or pressed into the band and comprise any of a plurality of patterns.

[19] In embodiments, the dental band may have a serrated edge, such as a serrated inferior edge, to increase security when applied to the tooth. As such, when the dental clamp tightens the dental band, the lower serrated edge can dig into the tooth, increase the hold of the clamp to the tooth and provide more stability to the overall device interface and structure.

[20] With respect to the dental clamp fixture, a plurality of clamp designs and embodiments can be utilized to secure the dental band to a tooth or teeth. In examples, the dental clamp can comprise a part of the dental band design, or be a separate fixture subsequently applied to the dental band.

[21] In various embodiments, one end of the dental clamp can contain a captive screw (as in Figs. 1-3). The dental band can be put around a tooth or teeth, and a loose end can be fed into a narrow space between the band and the captive screw. When the screw is turned, it acts as a drive pulling the threads of the band and causing the band to tighten around the tooth or teeth. Accordingly, when screwed in the opposite direction, the band will loosen. In embodiments, the screw is not captive or contained within a case.

[22] In other examples, the dental band and clamp comprise a cable tie design. In one embodiment, the device comprises an integrated gear rack secured to the dental band, and a ratchet, which can be contained within a small open case. In an example, the gear rack can be secured to the dental band using flexible tape. Once a leading end, e.g., a pointed tip of the cable tie, has been pulled through the case and past the ratchet, the band is prevented from being pulled back. Like a cable tie, the resulting loop may only be pulled tighter.

Consequently, a tensioning device or tool may be used to apply the dental band with a specific degree of tension. A tool may also be used to cut off any extra tail material so that the dental band is flush with the head, and to avoid a sharp edge which might otherwise cause a cut or injury.

[23] The dental clamp can further comprise a hose clamp, hose clip, or hose lock design, which each can be used to attach and seal a hose onto a fitting, such as a barb or nipple. The application of these types of clamps is direct attachment of the band to a tooth (or group of teeth) and securement to the tooth by cinching the band tightly. Again, the cinching of the band to the tooth or teeth could be done by many methods including the worm gear, a spring clamp, a wire clamp, or ear clamp.

[24] It will be appreciated that the dental clamps and overall intermaxillary fixation devices are not limited to the designs discussed herein. Dental clamp embodiments within the scope of the present disclosure may comprise one or more features from one or more of the designs discussed herein, in order to accomplish the features and goals of the intermaxillary fixation device.

[25] Turning again to Figs. 1-3, the disclosed devices further comprise at least one attachment for connecting two or more dental bands. For example, the dental band and/or the dental clamp affixed to the dental band, can comprise one or more hooks, ringlets, and similar attachments. As illustrated in Fig. 1, a ringlet 140 attaches to the dental clamp complex 120, which is affixed to the dental band 110. In Fig. 2, an example dental clamp complex similarly comprises a single ringlet 210, and another example comprises both a ringlet and a hook 220. [26] Fig. 3 similarly shows two possible device designs in accordance with the features and embodiments described herein. One embodiment 310 comprises a worm drive 315 attached to the dental band, and a ringlet 330 attached to the worm drive. In a second embodiment 320, the device comprises a worm drive and a hook attachment 340. It will be appreciated that the hook and/or ringlet attachments need not be connected to the dental clamp fixture, e.g., the screw, worm drive itself. In embodiments, the hook or ringlet is attached directly to the dental band. In other embodiments, the attachments can be removable and/or interchangeable so as to provide various design possibilities and customization.

[27] The ringlet, hook, and similar attachments provide for the application of wires, elastic bands, e.g., rubber bands, and similar connecting devices between two or more dental bands in order to stabilize a fracture site and hold the jaw in occlusion. Fig. 2 depicts an example of a link 230 connecting two dental bands applied to upper and lower teeth. Fig. 4 similarly depicts a link, comprising an elastic band, e.g., rubber band, connecting two dental bands. It will be appreciated that the band is not limited to an elastic or rubber band, may comprise any of a variety of one or more materials and properties, such as a metal wire, plastic band, elastic material, composite, or other structure. This process and flexibility in customization allows for the correct reduction and fixation of a fracture site for a variety of injuries. Such stabilization accordingly prevents movement of the maxilla/mandible complex and facilitates fracture healing.

[28] In various embodiments, depending upon the type of injury, dental bands may be applied to multiple teeth, and have one or more connecting links, such as wires and elastic bands connected to each dental band. These various configurations of wire attachments consequently allow for the jaw to be precisely positioned and stabilized to promote optimal healing.

[29] It will be appreciated that the various features and processes described above may be used independently of one another or may be combined in various ways. All possible combinations and sub-combinations are intended to fall within the scope of this disclosure.

[30] Conditional language used herein, such as, among others, "can," "could," "might," "may,"“e.g.,” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements, and/or steps. Thus, such conditional language is not generally intended to imply that features, elements and/or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without author input or prompting, whether these features, elements and/or steps are included or are to be performed in any particular embodiment. The terms“comprising,”“including,”“having,” and the like are synonymous and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations, and so forth. Also, the term“or” is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term“or” means one, some, or all of the elements in the list.

[31] While certain example embodiments have been described, these embodiments have been presented by way of example only, and are not intended to limit the scope of the inventions disclosed herein. Thus, nothing in the foregoing description is intended to imply that any particular feature, characteristic, step, module, or block is necessary or

indispensable. Indeed, the novel methods and systems described herein may be embodied in a variety of other forms; furthermore, various omissions, substitutions and changes in the form of the methods and systems described herein may be made without departing from the spirit of the inventions disclosed herein. The accompanying claims and their equivalents are intended to cover such forms or modifications as would fall within the scope and spirit of certain of the inventions disclosed herein

Claims

What is claimed:

1. A device for intermaxillary fixation, comprising:

a plurality of dental bands, each dental band surrounding a tooth;

for each of the plurality of dental bands:

a clamp affixed to an external face of the dental band, configured to secure the dental band to the tooth, and

at least one attachment for connecting two or more dental bands; and a link securing two or more dental bands at the attachment to provide intermaxillary fixation.

2. The device of claim 1, wherein the external face of the dental band further comprises a plurality of threads.

3. The device of claim 1, wherein the attachment is a ringlet or a hook.

4. The device of claim 1, wherein the clamp attaches and seals a hose on to a fitting on the dental band.

5. The device of claim 4, wherein the fitting is a barb or nipple.

6. The device of claim 1, wherein the clamp is a hose clamp, a hose clip, or a hose lock.

7. The device of claim 1, wherein the clamp secures the dental band to the tooth using a worm gear, a spring clamp, a wire clamp, or an ear clamp.

8. The device of claim 1, wherein the clamp comprises an integrated gear rack secured to the dental clamp with flexible tape.

9. The device of claim 1, wherein the clamp is a cable tie or tensioning device.

10. The device of claim 1, wherein the plurality of dental bands have a serrated inferior edge.

11. A method for intermaxillary fixation, comprising:

setting a dental band around a circumference of a tooth;

securing the dental band to the tooth using a clamp affixed to an external face of the dental band; and

connecting the dental band to a second dental band secured to a second tooth using a link, wherein the connecting provides intermaxillary fixation.

12. The method of claim 11, wherein each dental band is affixed at a position of largest circumference of the tooth.

13. The method of claim 11, wherein the clamp affixes the dental bands at a

predetermined tension.

14. The method of claim 11, wherein the link attaches to at least one or a hook and a ringlet on each of the dental bands.

15. The method of claim 11, wherein the dental bands comprise a serrated inferior edge to secure the dental band to the tooth.

16. The method of claim 11, wherein the clamp is a worm gear, a spring clamp, a wire clamp, or an ear clamp.

17. The method of claim 11, wherein each clamp comprises an integrated gear rack secured to the dental clamp with flexible tape.

18. The method of claim 11 , wherein the clamp is a hose clamp, a hose clip, or a hose lock.

19. The method of claim 11, the clamp attaches and seals a hose on to a fitting on the dental band.

20. The method of claim 11, wherein the link is a metal wire or a rubber band.