Dental appliance assembly for controlling forward mandibular advancement

Abstract

A dental appliance assembly (800) for controlling forward mandibular advancement including upper and lower dental trays (802a, 802b) each having a pair of button protrusions (806a, 806b) thereon, left and right dental straps (820) each having reinforced openings (822c) at opposite ends (822a, 822b) thereof, and a right dental strap (820) having reinforced openings (822c, 822d) at opposite ends (822a, 822b) thereof. Upon attaching the dental straps (820) to the dental trays (802a, 802b), the reinforced openings (822c, 822d) of the dental strap (820) receive corresponding button protrusions (806a, 806b) therethrough in a first dental strap orientation, and subsequently form a frictional fit between the reinforced dental strap openings (822d, 822c) and the button protrusions (806a, 806b) when the dental straps (820) are rotated about the button protrusions into a second dental strap orientation.

Description

DENTAL APPLIANCE ASSEMBLY FOR CONTROLLINGFORWARD MANDIBULAR ADVANCEMENTCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This PCT patent application claims priority to: co-pending U.S. Provisional Patent Application Ser. No. 63 / 522,369, filed on 21 June 2023; and co-pending U.S. Non-Provisional Patent Application Ser. No. 18 / 399,958, filed on 29 December 2023.FIELD OF THE INVENTION

[0002] The present invention is generally directed todental appliances for treating sleep apnea, and more particularly to such dental appliances that utilize forward mandibular advancement of a patient during sleep in order to provide increased airflow.BACKGROUND OF THE INVENTION

[0003] The present invention is generally directed to an improveddental appliance for controlling forward mandibular advancement of a patient, or wearer of the dental appliance, while sleeping, andto a system and methods for manufacturing such an improved dental appliance.

[0004] Treatments for sleep-disordered breathing (SDB), a condition that includes snoring and obstructive sleep apnea, include surgery, positive airflow machinery, such as CPAP machines, and dental appliances. Mandibular advancement devices, such as the Elastic Mandibular Advancement (EMA®) appliance, have become increasingly popular. This type of dental appliance typically includes upper and lower dental trays, and a pair of elastic straps that couple the upper and lower dental trays to one another on opposite sides of the respective dental trays. In particular, openings at opposite ends of each strap attach to corresponding strap hooks on opposite sides of the dental trays.

[0005] A drawback of the EMA® appliance is the risk of detachment of the strap hooks from the dental trays while upper and lower strap hooks on opposite sides of the respective upper and lower dental trays are coupled to one another by the elastic straps. Conventionally, the strap hooks are attached to opposite sides of the dental trays using dental cements including, for example, zinc phosphate, zinc oxide and eugenol, polycarboxylate (zinc oxide powder mixed with polyacrylic acid) and glass ionomer cements (GICs)). However, cementing the strap hooks can result in degradation at the cement interface between the strap hooks and the dental trays over time and with increased use; increasing the risk of complete detachment of strap hooks from the dental trays during use.Accordingly, there is a need for a dental appliance having a reduced risk of strap hook detachment from the dental trays.

[0006] Another drawback / limitation of the EMA® appliance is the risk of detachment of the elastic strap ends from the strap hooks while the appliance is being worn. Accordingly, there is a need for a dental appliance having a reduced risk of detachment of the elastic strap ends from the strap hooks during use. In particular, it would be highly desirable to provide an improved attachment, or coupling, mechanism between the strap hooks and elastic strap ends when the dental appliance is fully assembled (i.e., when the elastic straps are assembled to the dental trays via the strap hooks). It would be further desirable to provide structurally reinforced elastic strap ends and corresponding dental tray coupling structures (in lieu of conventional strap hooks) designed to be selectively engaged with one another to provide a sound and secure coupling in a locked state (i.e., when the dental appliance is in a completely assembled state).

[0007] Another drawback / limitation of the EMA® appliance (and related elastic mandibular advancement type dental appliances) relates to the inefficiencies of existing systems and methods of manufacturing such dental appliances. Conventional manufacturing ofthe EMA® appliance (and related elastic mandibular advancement dental appliances) requires a series of manual steps, including multiple steps of manually marking locations on patient impression models (e.g., using an EMA® template) to provide reference points for subsequently identifyingcorresponding strap hook attachment locations on upper and lower thermoformed dental trays disposed upon the respective upper and lower patient impression models. Manual marking also introduces human error when determining the strap hook attachment locations on the dental trays.

[0008] Accordingly, It would be desirable to provide a system and method for manufacturing patient-specific dental trays having button protrusions positioned on the upper and lower dental trays, such that the relative locations of the button protrusions on the upper and lower dental trays define the forward mandibular position when two connector straps are attached to couple the upper dental tray to the lower dental tray. It would be further desirable to provide such a system and method for manufacturing patient-specific dental trays, wherein one of the dental trays - preferably, the lower dental tray - has vertical displacement bite pads on left and right sides of the (lower) dental tray based on dentition data derived from oral characteristic data of the patient.SUMMARY OF THE INVENTION

[0009] In accordance with an aspect of the present invention, a system and corresponding methods provide are provided for more efficiently and more precisely manufacturing a forward mandibular advancement dental appliance.

[0010] Some embodiments of a system and method for manufacturing a forward mandibular advancement dental appliance may include receiving oral characteristic data of a patient, processing the oral characteristic data in a server to determine dentition data and a forward mandibular position to enable the patient to breathe during sleep by opening an airway of the patient, forming upper and lower dental trays using the dentition data and the forward mandibular position, the upper and lower dental trays each having homogenous bodies, the upper dental tray including a pair of upper dental tray plateaus and the lower dental tray including a pair of lower dental tray plateaus, ultrasonically welding a first pair of button protrusions onto the pair of upper dental tray plateaus and ultrasonically welding a second pair of button protrusions onto the pair of lower dental tray plateaus, and subsequently coupling each one of the upper button protrusions with a corresponding one of the lower button protrusions using a pair of elastic dental straps / bands to form a forward mandibular advancement dental appliance providing the forward mandibular position when the pair of elastic dental straps / bands are attached to connect the upper dental tray to the lower dental tray.

[0011] In one or more embodiments, the upper and lower dental trays are thermoformed using one or more of a thermoplastic polyester, polyethylene terephthalate glycol (PETG), an ethylene propylene copolymer, a polyoxymethylene copolymer, a thermoplastic olefin, a thermoplastic polyolefin, and an olefinic thermoplastic elastomer.

[0012] In one or more embodiments, the upper and lower dental trays are thermoformed using one or more of acrylic, acrylonitrile butadiene styrene (ABS), nylon, polylactic acid (PLA), polybenzimidazole, polycarbonate, polyether sulfone, polyoxymethylene, polyether ether ketone, polyetherimide, polyethylene, polyphenylene oxide, polyphenylene sulfide, polypropylene, polystyrene, polyvinyl chloride, polyvinylidene fluoride, and polytetrafluoroethylene.

[0013] In one or more embodiments, the ultrasonic welding includes, for each pair of button protrusions of the upper and lower dental trays, inserting the respective button protrusion into a sonotrode, each button protrusion being chemically compatible or identical in material to the respective upper and lower dental trays, placing the sonotrode at the respective plateau for the respective button protrusion according to the dentition data, vibrating the sonotrode via an ultrasonic transducer vertically between 20kHz and 40kHz times per second for a predetermined weld time to reach a melting point, maintaining a predetermined amount of hold time to allow fusing and hermeticity, andretracting the sonotrode after the hold time.

[0014] In one or more embodiments, the step of receiving oral characteristic data of a patient includes scanning by a scanner of an oral cavity of the patient, imaging the oral cavity to determine the dentition data, wherein the oral characteristic data includes dentition data as one or more images of teeth and a gum line of the patient, andtransmitting the oral characteristic data to a server.

[0015] At least one embodiment is directed to an alternate system and method including: (a) receiving, by a server, one or more data sets associated with a patient; (b) determining, by the server one or more positions for placement of button protrusions based on the received data sets from a scanner, the received data sets including at least a dentition pattern; (c) communicating, by the server the one or more positions for placement of the button protrusions, the step of communicating including assigning a value associated with each of the one or more positions for placement of the button protrusions, each value representative of a distance between an upper tray button protrusion and a respective lower tray button protrusion for mandibular advancement; (d) transmitting the value data to an injection molding apparatus; (e) forming upper and lower dental trays of a dental appliance using the value associated with each ofthe one or more positions for placement of button protrusions to determine locations for a plurality of plateaus for use by an ultrasonic welder, ultrasonically welding the first pair of button protrusions onto a first pair of dental tray plateaus on the lower dental tray, and ultrasonically welding the second pair of button protrusions onto a second pair of dental tray plateaus on the upper dental tray to provide a homogeneous dental appliance with the first pair of button protrusions and the second pair of button protrusions providing the forward mandibular position when two connectors are attached, via the respective first and second pairs of button protrusions, to connect the upper dental tray to the lower dental tray.

[0016] In one or more embodiments, the ultrasonic welding includes, for each button protrusion of the upper and lower button protrusions, inserting the respective button protrusion into an ultrasonic horn, each button protrusion being chemically compatible or identical in material to the upper and lower dental tray, placing the ultrasonic horn at a predetermined location for the respective button protrusion according to the dentition data, vibrating the ultrasonic horn via an ultrasonic transducer vertically between 20kHz and 40kHz times per second for a predetermined weld time to reach a melting point, maintaining a predetermined amount of hold time to allow fusing and hermeticity, and retracting the ultrasonic horn after the hold time.

[0017] In one or more embodiments, the lower dental tray is inclusive of a first vertical displacement bite pad on a left side of the lower dental tray and a second vertical displacement bite pad on a right side of the lower dental tray wherein a height of each of the first and second verticaldisplacement bite pads is determined according to the oral characteristic data, the oral characteristic data providing soft tissue data of the patient indicative of airway function.

[0018] In one or more embodiments, the vertical displacement is provided by at least one pair of bite pads ultrasonically welded on the lower dental tray.

[0019] In accordance with another aspect of the invention, an improved dental appliance assembly is provided for controlling forward mandibular advancement of a patient wearing the dental appliance.

[0020] In accordance with some embodiments, the improved dental appliance assembly may include: a lower dental tray having left and right button protrusions extending outwardly from respective left and right sides of the lower dental tray; an upper dental tray having left and right button protrusions extending outwardly from respective left and right sides of the upper dental tray; a left dental strap having reinforced openings at opposite ends thereof; and a right dental strap having reinforced openings at opposite ends thereof, wherein when the left and right dental straps are assembled to the respective left and right sides of the lower and upper dental trays, the reinforced openings in the left and right dental straps are sized and shaped to receive the button protrusions therethrough in a first dental strap orientation, and subsequently form a frictional fit between the reinforced dental strap openings and the button protrusions when the dental straps are rotated into a second dental strap orientation.

[0021] In accordance with one or more embodiments, the left and right button protrusions may include: a base portion protruding outwardly from the left and right sides of the upper and lower dental trays; a distal end portion; and a central portion adjoining the base portion and the distal end portion.

[0022] In accordance with one or more embodiments, each dental strap may include: a pair of locking members constructed from a first thermoplastic material having a first durometer; and a dental strap body constructed from a second thermoplastic material having a second durometer less than the first durometer of the first thermoplastic, and having opposite dental strap body ends with openings extending completely therethrough,wherein a peripheral portion of each one of the pair of locking members is overmolded with the second thermoplastic material, and each one of the pair of locking members has a central opening extending completely therethrough and concentric with a corresponding one of the openings at the opposite ends of the dental strap body, and wherein the central opening of each one of the pair of overmolded locking members is sized and shaped to snugly receive the distal end portion of a corresponding button protrusion therethrough in a first, unlocked dental strap orientation, and subsequently form a frictional fit between the locking member central opening and the central portion of the corresponding button protrusion when the dental strap is rotated thereabout into a second, locked dental strap orientation.

[0023] In accordance with one or more embodiments, the button protrusions may be sonically welded onto exterior side surfaces of the upper and lower dental trays.

[0024] In accordance with one or more embodiments, the button protrusions and corresponding dental trays may be integrally formed into a homogenous, monolithic structure using a milling process, an injection molding process, or a 3D printing process.

[0025] In accordance with one or more embodiments, the homogenous, monolithic structure of the dental tray and integral button protrusions may be constructed by milling a solid material “puck” made from an FDA approved materials such as, for example: an ethylene propylene copolymer, a polyoxymethylene copolymer, a thermoplastic olefin, a thermoplastic polyolefin, or an olefinic thermoplastic elastomer.

[0026] In accordance with one or more embodiments, the homogeneous, monolithic structure of the dental trays and integral button protrusions may be constructed by injection molding an appropriate material such as, for example, thermoplastics, thermoplastic elastomers, and the like.

[0027] In accordance with one or more embodiments, the homogeneous, monolithic structure of the dental trays and integral button protrusions may be constructed by 3D printing an appropriate material such as, for example, thermoset polymers (e.g., light polymerizable liquid materials) and crosslinked polymers (e.g., a polyurethane, a methacrylate, or a copolymer).

[0028] In accordance with one or more embodiments, the homogenous, monolithic structure of the dental trays manufactured by milling, injection molding, or 3D printing may include integrally formed mandibular (i.e., lower dental tray) bite pads.

[0029] In accordance with one or more embodiments, the first durometer of the first thermoplastic material used to construct the locking members, and the second durometer of the second thermoplasticmaterial used to construct the dental strap body are both within a range of 55 Shore A and 115 Shore A.

[0030] In accordance with one or more embodiments, the first thermoplastic material used to construct the locking members has first durometer that is at least 20 points Shore A greater that the second durometer of the second thermoplastic material used to construct the dental strap body partially overmolding the locking members.

[0031] In accordance with one or more embodiments, the first thermoplastic used to construct the locking members has a first durometer of at least 100 Shore A, and the second thermoplastic used to construct the dental strap body partially overmolding the locking members has a second durometer within a range of 55 Shore A to 90 Shore A.

[0032] In accordance with another aspect of the invention, an improved method is provided for constructing a dental strap of a dental appliance assembly for controlling forward mandibular advancement of a patient wearing the dental appliance assembly, the method including: injection molding a first thermoplastic material to form a pair of locking members having a first durometer / hardness; and injection molding a second thermoplastic material to form a dental strap body having a second durometer / hardness, the dental strap body overmolding perimeter portions of each one of the pair of locking members, wherein the first durometer / hardness of the injection molded pair of locking members is at least 20 points Shore A greater than the second durometer / hardness of the injection molded dental strap body.

[0033] In accordance with one or more embodiments, the first injection molded thermoplastic used to form the pair of locking members is a polyethylene terephthalate (PTE).

[0034] In accordance with one or more embodiments, the second injection molded thermoplastic material used to form the dental strap body partially overmolding the pair of pair of locking members is a glycol-modified polyethylene terephthalate (PETG).

[0035] In accordance with one or more embodiments, the method of injection molding the first and second thermoplastic materials may comprise overmolding of polyethylene terephthalate (PTE) with thermoplastic elastomer (TPE), wherein the PTE is a glycol-modified polyethylene terephthalate (PETG).

[0036] In accordance with one or more embodiments, the method of injection molding the first and second thermoplastic materials may comprise injection overmolding the first thermoplastic material with a thermoplastic elastomer (TPE) material, thereby forming a chemically bonded material of a copolyester and a TPE.

[0037] These and other features, aspects, and advantages of the invention will be further understood and appreciated by those skilled in the art by reference to the following written specification, claims and appended drawings.BRIEF DESCRIPTION OF DRAWINGS

[0038] The invention will now be described, by way of example, with reference to the accompanying figures, where like numerals denote like elements, and in which:

[0039] FIG. 1 A illustrates a system and network environment having a first configuration, including a computing device, in accordance with one or more embodiments of the present disclosure;

[0040] FIG. 1 B illustrates a block diagram of a system and network environment having a second configuration, including a processor and a computing device, in accordance with one or more embodiments of the present disclosure;

[0041] FIG. 2 illustrates a network environment having a third configuration, in accordance with one or more embodiments of the present disclosure;

[0042] FIG. 3 illustrates a homogeneous dental appliance including an upper plateau on an exterior side of an upper dental tray, a first lower plateau on an exterior side of a lower dental tray, and a second lower plateau on an exterior top side of the lower dental tray, wherein the upper plateau and the first lower plateau define sites for ultrasonic welding attachment of corresponding upper and lower button protrusions (not shown), and the second lower plateau defines a site for ultrasonic welding attachment of a corresponding vertical bite pad;

[0043] FIG. 4 illustrates an ultrasonic welding device with a dental appliance having button protrusions welded onto the appliance in accordance with one or more embodiments of the present disclosure;

[0044] FIG. 5 illustrates a view of a sonotrode appropriate for holding a button protrusion for ultrasonic welding in accordance with one or more embodiments of the present disclosure;

[0045] FIG. 6 illustrates a flow diagram of a method in accordance with one or more embodiments of the present disclosure;

[0046] FIG. 7 illustrates a perspective view of a dental appliance with button protrusions and vertical bite pads ultrasonically welded thereon;

[0047] FIG. 8 illustrates a perspective exploded view of an improved dental appliance assembly for controlling forward mandibular advancement, including: an upper dental tray having integrally formed button protrusions; a lower dental tray having integrally formed button protrusions and integrallyformed vertical bite pads; and a pair of elastic dental straps having reinforced openings at respective ends thereof;

[0048] FIG. 9 illustrates a perspective view of the improved dental assembly in a fully assembled, ready to use state;

[0049] FIG. 10A illustrates a perspective view of an exemplary locking member for use constructing the reinforced openings at respective ends of the pair of elastic dental straps;

[0050] FIG. 10B illustrates an elevated front plan view of the exemplary locking member introduced in FIG. 10A;

[0051] FIG. 11A illustrates an elevated front plan view of the elastic dental strap, with the overmolding of upper right end shown partially cutaway to expose the upper surface of locking ring;

[0052] FIG. 11 B illustrates an elevated front plan view of the elastic dental strap with the reinforced opening at the left end received about an upper tray button protrusion in an unlocked position;

[0053] FIG. 11 C illustrates an elevated front plan view of the elastic dental strap with the reinforced opening at the left / upper end rotated (A) about the upper tray button protrusion into a locked position;

[0054] FIG. 12 illustrates a cross-sectional view taken along section line 12-12 of FIG. 11 C to show the frictional engagement between the reinforced opening and the upper tray button protrusion with the elastic dental strap in a locked position;

[0055] FIG. 13 illustrates a rear elevation view of the dental appliance in a fully assembled state as originally introduced in FIG. 9;

[0056] FIG. 14A illustrates a perspective view of a locking ring in accordance with an alternate embodiment;

[0057] FIG. 14B illustrates a front elevation view of the locking ring introduced in FIG. 14A;

[0058] FIG. 15A illustrates an upper perspective view of a button protrusion in accordance with an alternate embodiment, wherein a distal end portion has a foot print congruent with the footprint of the corresponding opening through the alternate locking ring, enabling it to be snugly received through the corresponding opening of the locking ring;

[0059] FIG. 16A illustrates a front perspective view of an elastic dental strap in accordance with an alternate embodiment, wherein the alternate locking rings are overmolded into the upper and lower ends of the elastic dental strap body to form respective upper and lower reinforced openings; and

[0060] FIG. 16B illustrates a front elevation view of the elastic dental strap introduced in FIG. 16A.DESCRIPTION OF THE INVENTION

[0061] The following detailed description is merely exemplary in nature and is not intended to limit the described embodiments or the application and uses of the described embodiments. As used herein, the word “exemplary” or “illustrative” means “serving as an example, instance, or illustration.” Any implementation described herein as “exemplary” or “illustrative” is not necessarily to be construed as preferred or advantageous over other implementations. All of the implementations described below are exemplary implementations provided to enable persons skilled in the art to make or use the embodiments of the disclosure and are not intended to limit the scope of the disclosure, which is defined by the claims. There is no intention to be bound by any expressed or implied theory presented in the preceding technical field, background, brief summary or the following detailed description. It is also to be understood that any specific devices and processes illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments of the inventive concepts defined in the appended claims. Hence, specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered as limiting, unless the claims expressly state otherwise. Other embodiments may be utilized, and other changes made, without departing from the spirit or scope of the subject matter presented herein.

[0062] Referring initially to FIGS. 1-7, in accordance with an aspect of the present invention, a system and corresponding methods are provided for more efficiently and more precisely manufacturing a forward mandibular advancement dental appliance based upon specific oral characteristics of each individual patient.

[0063] Referring now to FIG. 1A, the figure illustrates a computing device 10 connected via a network interface to a computer server 30 in an exemplary environment 100. As will be further described herein the illustrated computing device 10 and computer server 30 may employ the computationally implemented methods, systems, and articles of manufacture in accordance with various embodiments. The computing device 10 and computer server 30, in various embodiments, enable functions of the computing device 10.

[0064] Computing device 10 illustrated in FIG. 1A can be a tablet computer, in alternative embodiments, the computationally implemented methods, systems, and articles of manufacture in accordance with various embodiments may be embodied in other types of computer systems having other form factors including other types of portable computing devices such as, for example, mobile telephones, laptops, smartphones, e-readers, and so forth. Computing devices can include smartphones, client computers and the like as possible computing devices. As illustrated, the computing device 10 can include a display, such as a touchscreen as input / output of the computingdevice 10. Computing device 10 can further include a keyboard, either as a touch input / output keyboard or as an attached keyboard. As further depicted, the computing device 10 may also be connected to a scanner 16. In one embodiment, scanner 16 can be a scanning camera capable of creating a 3D image of teeth.

[0065] Referring now to FIG. 1 B, computing device 10 is further illustrated with logic modules 102, network interface 104, user interface 110, processors 116 and memory 114. Logic modules 102 can be implemented using circuit components such as ASIC, logic modules 102 and other modules shown, may be implemented using a combination of specifically designed circuitry such as ASIC and one or more processors 116 (or other types of circuitry such as field programmable gate arrays or FPGAs) executing computer readable instructions 152. For example, in some embodiments, at least one of the logic modules may be implemented using specially designed circuitry (e.g., ASIC) while a second logic module may be implemented using a processor 116 (or other types of programmable circuitry such as an FPGA) executing computer readable instructions 152 (e.g., software and / or firmware). System requirements could dictate a combination of software and firmware and circuitry to meet the embodiments herein, for example, logic modules could be designed to use the most efficient combination of software / hardware / firmware in order to quickly implement methods and systems within the scope of the present disclosure. In some embodiments, a Computer-Aided Design / Computer-Aided Manufacture (CAD / CAM) program operates to implement methods herein for forming a dental appliance from scanned images. For example, a CAD program can create data in a three-dimensional format and transmit the data to a manufacturing device, such as a 3D printer, milling machine, or injection mold creation device. Methods herein include using patient-oriented oral characteristic data to determine placement of button protrusions and vertical displacement automatically by categorizing a patient’s sleep apnea needs according to soft tissue characteristics and dentition. Soft tissue as described herein refers to soft palate, gum line, uvula placement as well as hyoid tissue and the like in an oral cavity of a patient.

[0066] In various embodiments, the memory 114 of the computing device 10 may comprise of one or more of mass storage device, read-only memory (ROM), programmable read-only memory (PROM), erasable programmable read-only memory (EPROM), cache memory such as random access memory (RAM), flash memory, synchronous random access memory (SRAM), dynamic random access memory (DRAM), and / or other types of memory devices. In various embodiments, the one or more applications 160 stored in memory 114 may include, for example, an operating system 162, a browser(s) 163, and one or more productivity applications 164 such as a word processing application or an imaging application, scanning application and one or more communication applications 166.

[0067] Computing device 10 may also include access restricting module 106. Access restricting module 106 of the computing device 10 can be configured to restrict access via the computing device 10 or prevent one or more actions by computing device 10. Computing device 10 may also include appliance generation module 108 coupled to access restricting module 106 via a bus.

[0068] Referring to FIG. 2, appliance generation module 108 may be configured to determine that a first user 20 is an authorized user attempting to operate computing device 10. Appliance generation module 108 can also be configured to determine an established authorized user based on network received data while computing device 10 is connected to a network connection 50. In the case of appliance generation module 108, existing in a cloud computing setting or computer server 30, appliance generation module 108 may be configured to determine a network-based authorization for the first user when first logging into network 50 or cloud computing logging to computer server 30.

[0069] Appliance generation module 108 can be configured to receive inputs from a scanner 16. In some embodiments, appliance generation module 108 is coupled to a device capable of directing thermoforming of dental appliances. Appliance generation module 108 can receive CAD / CAM data or other oral characteristic data and / or dentition data to enable creation of a dental appliance in accordance with one or more embodiments herein.

[0070] Computer server 30 connecting via network 50 to the computing device 10 of FIGS. 1A and 1 B can establish and / or determine a vertical displacement and a forward mandibular position for treating sleep apnea. For example, scanner 16 and / or molds of a patient's teeth can be examined and used to determine the adjustment needed for treating sleep apnea. Upper and lower trays including button protrusions can be created from molds. For instance, a patient with malocclusion and sleep apnea will require a determination via scanner 16 or other method. Each patient, depending on the results of scanned teeth or impressions for a three dimensional data file and soft tissue and patient feedback, may require a different placement of horizontal and vertical displacement for both treating sleep apnea. Vertical displacement can be by way of lower bite pads or by way of the thickness of a lower dental tray.

[0071] In one embodiment, scanner 16 scans an oral cavity of patient to image the oral cavity to determine the dentition data, including oral characteristic data as one or more images of teeth and a gum line of the patient, andtransmitting the oral characteristic to a server. In one or more embodiments, the dentition data includes gum line data to enable retention of the dental appliance for the patient.

[0072] More specifically, an appliance can be better retained if the trays are designed to fit at the gum line. Thus, in some embodiments, methods herein include determining a 3 millimeter distancebelow a tooth crown-gingival junction on the upper dental tray unless there is a protrusive axial inclination of the incisors. For protrusive axial inclinations of incisor patients, the upper dental tray is formed to reach one third to one half the way up on the anterior teeth. The lower dental tray is formed to reach 3 millimeters below a tooth crown-gingival juncture unless a patient’s mandibular incisors also have a protrusive axial inclination. For protrusive axial inclination of mandibular incisor patients, the lower dental tray is formed to reach above the tooth crown-gingival area at the anterior incisors. The gum line data is provided to form the dental trays prior to use of molds of the patient’s teeth.

[0073] In one embodiment, the dentition data enable molds to be formed that may be used for thermoforming of plastics on top of the mold(s)to enable an FDA approved material such as a thermoplastic material to form an upper and lower tray adapted to fit tightly but removably over upper and lower teeth such that the lower tray creates the forward mandibular position with respect to the upper tray when connectors are releasably attached to the forward and the rearward portions of the opposite sides of the upper and lower trays, respectively, to enable the forward mandibular position of the lower tray with respect to the upper tray. Button protrusions on the lower dental tray and on the dental upper tray are arranged to enable such connectors such as elastic bands or durable nylon bands or the like to attach thereto.

[0074] One embodiment includes determining a dimension and elasticity for one or more removably attachable connector bands adapted to connect the upper and lower tray via button protrusions on each of the upper and the lower trays such that the bands create the forward mandibular position of the lower tray with respect to the upper tray. Connector bands can include a plurality of pairs of elastic bands, each pair being of different length and / or elasticity.

[0075] In one embodiment, the dental appliance 300 is configured to be worn during sleep. As shown in FIG. 3, the dental appliance 300 can include upper and lower trays 310, 320 that are manufactured using data collection via scanning or the like, that can be sent to a three dimensional printer to create a mold of a patient’s teeth. The mold may also be made using the actual patient’s teeth via impressions as one of skill in the art would appreciate with the benefit of the present disclosure.

[0076] Still referring to FIG. 3, the dental appliance 300 is shown including an upper tray 310, lower tray 320, a plateau for welding upper button protrusion 350, a plateau for later welding a lower button protrusion 360 and a plateau for ultrasonic welding bite pad 370. A similar plateau for a bite pad is not shown. In one or more embodiments, bite pads may or may not be included on a dental tray. Unlike other dental appliances that have glued button protrusions and lower bite pads, embodiments herein include bite pads and / or button protrusions that are formed separately by injection molding andthen attached to dental trays by ultrasonic welding. Embodiments disclose forming a dental appliance homogeneously with button protrusions and / or vertical displacement bite pads manufactured from the same or compatible materials as the dental trays themselves so that the final product is a homogeneous dental appliance. By bonding based on the melting and fusion of the material of the buttons and / or bite pads onto the dental trays via ultrasonic welding, no gluing and pressure pots are required. The time for ultrasonic welding efficiently reduces the overall time for manufacturing and the risk of detachment of components is greatly reduced.

[0077] In one or more embodiments, button protrusions 330 and bite pads 370 may be injection molded prior to being attached to a lower tray 320 and upper tray 310, and, in some embodiments prior to receiving the data of a particular patient. Such materials for bite pads and button protrusions, according to one or more embodiments, are chemically compatible and / or identical to the material used for the upper and lower dental trays 310, 320. One such thermoplastic appropriate for embodiments includes thermoplastic polyester such as polyethylene terephthalate glycol (PETG), when the upper and lower dental trays are also composed of PETG. One of skill in the art will appreciate that other chemically compatible materials for both injection molding and thermoforming combined with ultrasonic welding as disclosed herein are within the scope of the present invention. Materials appropriate for dental appliances according to some embodiments are FDA approved. In some embodiments, the button protrusions can be formed via injection molding. For example, a mold can be used to form individual button protrusions for the upper and lower dental trays in advance and stored as necessary.

[0078] In some embodiments, button protrusions and different sized bite pads may be premanufactured for later ultrasonic welding onto individual patient dental trays. Thus, a dental appliance can be thermoformed and the button protrusions and / or the dental pads on the lower dental tray added later via ultrasonic welding such that button protrusions and / or bite pads are part of one homogeneous dental tray independent of later gluing or cementing of the button protrusions and bite pads. Advantageously, ultrasonic welding avoids the time required for gluing and cementing by making pressure pots and the like unnecessary.

[0079] After receiving patient specific data from a scanner or impressions or the like, the upper dental tray of a dental appliance and the bottom dental tray are thermoformed over the molds of the patient’s teeth. Using the patient specific data, the molds include a plurality of plateaus for enabling ultrasonic welding of the button protrusions onto thermoformed dental trays. For example, the patient specific data may indicate a location for button protrusions appropriate for providing advancement of the mandible to prevent snoring or sleep apnea.

[0080] In one embodiment, the plateaus thermoformed as part of the upper and lower dental trays enable ultrasonically welding a first pair of button protrusions onto a pair of lower dental tray plateaus of the plurality of plateaus on the lower dental tray, andultrasonically welding the second pair of button protrusions onto a pair of upper dental tray plateaus of the plurality of plateaus. By ultrasonically welding chemically compatible button protrusions onto the dental trays, the system and method produces a homogeneous dental appliance with the first pair of button protrusions and the second pair of button protrusions providing forward mandibular position when two connectors are attached to connect the upper dental tray to the lower dental tray. The two connectors, in one embodiment may be elastic bands, nylon bands or the like.

[0081] In embodiments, materials appropriate for injection molding the protrusion buttons, bite pads, and also thermoforming dental trays with plateaus may be any compatible thermoplastic that may also be ultrasonically welded including resin-type materials and materials described in U.S. Patent No. 9,682,018 to Sadowsky et al., June 20, 2017, "Denture Tooth and Material" which is hereby incorporated by reference in its entirety. Appropriate materials for resins is further described in Tanaka J, Hashimoto T., Stansbury JW, Antonucci JM, Suzuki K., "Polymer Properties of Resins Composed of UDMA and Methacrylates With the Carboxyl Group" Dental Material Journal 2001 ; 10:206-215, which incorporated by reference herein in its entirety.

[0082] In one or more embodiments, the materials used may include Ethylene Propylene Copolymers having the following properties as shown in Table 1 :TestPhysical Nominal Value UnitMethodDensity-Specific Gravity (Method B) ASTM D792 .902 sp gr 23 / 23° CMelt Mass-Flow RateASTM D1238 40 g / 10 min(MFR)MechanicalTensile Strength @ Yield ASTM D638 4060 psiTensile Elongation @ Yld ASTM D638 12.00% 1 % Secant: 145000Flexural Modulus (Procedure A) ASTM D790 psiImpactNotched Izod ImpactASTM D256 ,0899 ft lb / in(73°F)ThermalDTUL @66psi -ASTM D648 194° FUnannealedOpticalHaze ASTM D1003 6.00%

[0083] In another embodiment, the injection molding and thermoforming material suitable for ultrasonic welding to a dental tray can be provided by a Polyoxymethylene Copolymer with the following properties shown in Table 2:Physical Test Method Nominal Value UnitSpecific Gravity ASTM D792 1.41Melt Mass-Flow Rate (MFR) ASTM D1238MechanicalTensile Strength ASTM D638 8800 psiTensile Elongation ASTM D638 60.00%Flexural Modulus ASTM D790 .38 psi x 106ImpactImpact Strength, Izod, ASTM D256 1 ft-lb / in notched 1 / 8 in (3.18 mm) sectionThermalDeflectionTemperatureASTM 648 @ 264 psi (1.82 Mpa)DeflectionTemperatureASTM D648 @ 66psi 315 (0.45 Mpa)

[0084] Other materials appropriate for embodiments include acrylic, Acrylonitrile butadiene styrene (ABS), nylon, polylactic acid (PLA), Polybenzimidazole, Polycarbonate. Polyether sulfone, Polyoxymethylene, Polyether ether ketone, Polyetherimide, Polyethylene, Polyphenylene oxide, Polyphenylene sulfide, Polypropylene, Polystyrene, Polyvinyl chloride, Polyvinylidene fluoride, and Polytetrafluoroethylene (Teflon).

[0085] Referring now to FIG. 4 an ultrasonic welder 500 is illustrated appropriate for welding button protrusions on to a dental appliance. As shown, sonotrode 410 or “horn” and fixture 420 are designed to hold a button protrusion (or bite pad) by inserting a separate button protrusion 430 into a depression, securing the button protrusion welded onto a dental tray as button protrusion 440 onto dental tray 450. The fixture 420 is shown holding a dental tray 450 with an exemplary button protrusion 440 ultrasonically welded onto the dental tray to form a homogeneous tray due to the compatible chemical properties of the components forming a joining that essentially melts the two compatible thermoplastics to create a secure homogeneous bond.

[0086] Referring to FIG. 5, a close up view 500 illustrates sonotrode 410 according to one embodiment. As shown depression 430 illustrates where a button protrusion may be placed forultrasonic welding. The button protrusion, as shown, can be any shape appropriate for securing a connector. For example, some button protrusions may be hook like. Other button protrusions may be designed to work with specific connectors or generic connectors. For example, elastic bands may be pliable enough to connect many different types of button protrusions.

[0087] Referring to FIG. 6, a flow diagram illustrates a method according to embodiments. More particularly, with reference to FIGS. 1 A, 1 B and 2, the method 600 includes at 610 receiving oral characteristic data of a patient. For example, a scanner 16 may collect data and provide it to cloud 30 for sending to an appliance generation module 108. Block 620 provides for processing the oral characteristic data in a server 30 to determine dentition data, and a forward mandibular position to enable the patient to breathe during sleep by opening an airway of the patient. Block 630 provides for forming a dental appliance using the dentition data and the forward mandibular position, the dental appliance including a lower dental tray and an upper dental tray, each of the lower dental tray and the upper dental tray being homogeneous. For example, the dentition data received via cloud 30 may be used to form a mold of an upper and lower dental tray as shown in FIG. 3, with plateaus 330, 332 and 370 for receiving button protrusions and bite pads via ultrasonic welding.

[0088] Block 640 provides for ultrasonically welding a first pair of button protrusions on the lower dental tray. For example, as shown in FIG. 4 ultrasonic welder 400 may be used to weld button protrusions onto plateaus 330, 332 and / or 370 created by thermoforming upper and lower dental trays.

[0089] Block 650 provides for ultrasonically welding a second pair of button protrusions on the upper dental tray to provide a homogeneous dental appliance with the first pair of button protrusions and the second pair of button protrusions providing the forward mandibular position when two bands are attached to connect the upper dental tray to the lower dental tray. For example, as shown in FIG. 4, ultrasonic welder 400 may be used to weld button protrusions.

[0090] Block 660 provides for each ultrasonic weld, inserting the respective button protrusion into an ultrasonic horn, each button protrusion being chemically compatible or identical in material to the upper and lower dental tray. For example, sonotrode 410 includes a depression for insertion of a button protrusion.

[0091] Block 670 provides for placing the sonotrode at a predetermined location for the respective button protrusion according to the dentition data. For example, the predetermined location may be a plateau 430, 432 appropriate for welding a button thereto.

[0092] Block 680 provides for vibrating the sonotrode via an ultrasonic transducer vertically between 20kHz and 40kHz times per second for a predetermined weld time to reach a melting pointand maintaining a predetermined amount of hold time to allow fusing and hermeticity, then retracting thesonotrode after the hold time. As shown in FIG. 4, the ultrasonic welder 400 may quickly fuse thermoplastics together.

[0093] Referring now to FIG. 7, dental appliance 700 is illustrated as a final product after ultrasonically welding button protrusions and / or bite pads on an upper dental tray 702 and lower dental tray 704. Connectors 708 may be nylon or elastic bands connecting either side of the dental appliance connecting button protrusion 710, 720.

[0094] The resulting dental appliance, from injection molding button protrusions and / or bite pads and ultrasonically welding the buttons and bite pads onto unique upper and lower dental tray according to dentition data of a patient, beneficially provides a homogeneous dental appliance without risking detachment associated with glues and other chemical adhesives, andwhich provides a significantly decreasedmanufacturing time. Prior methods required different components such as button protrusions and bite pads to be added by gluing or the like or encased in a thermoforming method.

[0095] As described above, a dental appliance is formed by, in one or more embodiments, a method including receiving oral characteristic data of a patient, processing the oral characteristic data in a server to determine dentition data, a vertical displacement and a forward mandibular position to enable the patient to breathe during sleep by opening an airway of the patient; forming a dental appliance using the dentition data and the forward mandibular position, the dental appliance including a lower dental tray and an upper dental tray, each of the lower dental tray and the upper dental tray being homogeneous, the upper dental tray including a pair of upper dental tray plateaus, the lower dental tray including a pair of lower dental tray plateaus, ultrasonically welding a first pair of button protrusions onto the pair of lower dental tray plateaus; and ultrasonically welding a second pair of button protrusions onto the upper dental tray plateaus to provide the homogeneous dental appliance with the first pair of button protrusions and the second pair of button protrusions providing the forward mandibular position when two connectors are attached to connect the upper dental tray to the lower dental tray.

[0096] In one or more embodiments receiving oral characteristic data of the patient includes scanning by a scanner or camera to create a mold of teeth of the patient and transmitting the oral characteristic data to a server.

[0097] In one or more embodiments receiving oral characteristic data of a patient includes scanning by a scanner of an oral cavity of the patient, imaging the oral cavity to determine the dentition data, wherein the oral characteristic data includes dentition data as one or more images of teeth and a gum line of the patient and transmitting the oral characteristic to a server.

[0098] Computer server 30 connecting via network 50 to the computing device 10 of FIG. 1A can establish and / or determine a vertical displacement and a forward mandibular position for treating sleep apnea. For example, scanner 16 and / or molds of a patient's teeth can be examined and used to determine the adjustment needed for treating sleep apnea. Upper and lower chassis including button protrusions can be created from molds and injection molded prior to reformable thermoplastic layers are injection molded as an overmolding. For instance, a patient with malocclusion and sleep apnea will require a determination via scanner or other method. Each patient, depending on the results of scanned teeth and soft tissue and patient feedback, may require a different placement of horizontal and vertical displacement for both treating sleep apnea. Vertical displacement can be by way of lower bite pads or by way of the thickness of a lower dental tray.

[0099] In some embodiments, the elastic straps can be of different lengths and strengths to enable a gradual and incremental titration to advance the mandible forward, for example some are 21 mm long but may be softer or stronger elastic. In some embodiments, nine different lengths may be provided and four different strengths may be offered for patient comfort and efficacy.

[0100] In one or more embodiments, bite pads can be snap-on type bite pads according to a determined amount of vertical component required for a patient with sleep apnea, or height of bite pads for the dental appliance as a function of the shape of the soft palate. In other embodiments, the vertical displacement is determined by the soft tissue of the patient, such as the hyoid shape. In one or more embodiments, a scanner and / or camera such as scanner / camera detects shape of soft palate. The data is collected as oral characteristic data and provided to a processor which operates to classify the oral characteristics for fabrication of the upper and lower dentition appliance chassis.

[0101] In one or more embodiments, there are three classifications for a soft palate: short, normal or long. Thus, in one or more embodiments, a method includes determining if the posterior edge of the soft palate is short. For example, if there is 5 to 7 mm of space between the posterior edge of the soft palate to the posterior wall of the oral pharynx, the soft palate is determined to be short, and a dental appliance will need 5 to 7mm of vertical displacement. In some embodiments, to determine the vertical displacement, a scanner can measure the distance from the gingival-tooth crown juncture of the maxillary central to the gingival-tooth crown juncture of the mandibular central. If this distance is, for example, 20mm and, thus, 7mm of vertical is desired, in some embodiments, a vertical displacement can be determined such that the bite will have 7mm of vertical displacement.

[0102] In some embodiments, a method includes determining if the posterior edge of the soft palate is longer than a normal soft palate. If the soft palate is longer such that the posterior edge of the soft palate has 3 to 4mm of space between it and the posterior wall of the oral pharynx, in someembodiments, a dental appliance can be made to provide 8 to 10mm of vertical displacement to keep the soft palate from closing the airway when the patient in a supine position.

[0103] If the soft palate is very long and webbed shaped with just 2mm or less of space between the soft palate and the posterior wall of the oral pharynx, the appliance will likely require 11 to 14mm of vertical displacement.

[0104] In one or more embodiments, a scanner 16 determines whether a soft palate is short, long or normal and determines the placement of the uvula with respect to the palate.

[0105] Determining the placement and size of the lower dental tray bite pads is a function of the length of the palate of a patient. Additionally, in some embodiments, maxillary button protrusions on an upper dental tray are placed on each incisal edge, in the embrasure between the right and left cuspids and first bicuspids.

[0106] The placement of the mandibular button protrusions (lower dental tray button protrusions) can be determined by determining a patient's range of motion. In some embodiments, a scanner detects maximal range of motion by measuring before and after extension of the lower jaw. For example, if the patient has only 5-7mm of potential advancement, the buttons are placed 23mm apart with the patient's teeth in centric. If the patient has 7-10mm of potential advancement, the buttons are placed 25mm apart, and if the patient has 10-17mm of potential advancement, the buttons are placed 27mm apart.

[0107] In one or more embodiments, a method includes determining the location of the buttons on the mandibular arch by occluding the patient's models in centric and placing the center of the mandibular button 23, 25, or 27mm from the center of the maxillary button.

[0108] As described above, a scanner / camera 16 takes images / scans of a patient's mouth to determine dentition data and / or soft palate data, and a computer system coupled to the scanner or processor incorporated into a scanner / camera determines the placement of the button protrusions and bite pads on the upper and lower dental appliance dental trays.

[0109] In one or more embodiments, receiving oral characteristic data of the patient includes scanning by a scanner or camera a mold of the teeth; and transmitting the oral characteristic data to a server.

[0110] In one or more embodiments receiving oral characteristic data of a patient includes scanning by a scanner of an oral cavity of the patient; imaging the oral cavity to determine the dentition data, wherein the oral characteristic data includes dentition data as one or more images of teeth and agum line of the patient and one or more images of a soft palate of the patient; and transmitting the oral characteristic to a server.

[0111] In one or more embodiments determining the oral characteristic data and vertical displacement is a function of a shape of the soft palate of the patient.

[0112] In one or more embodiments the step of determining, via the oral characteristics, the vertical displacement as a function of the shape of the soft palate of the patient includes determining a vertical displacement of between 5 and 7 millimeters if the soft palate has between 5 to 7 millimeters of space between a posterior edge of the soft palate to a posterior wall of an oral pharynx of the patient. Determination of the vertical displacement via the oral characteristic data may be as a function of the shape of the soft palate of the patient, including processing the oral characteristic data to measure a distance from a gingival-tooth crown juncture of a maxillary central to a gingival-tooth crown juncture of a mandibular central.

[0113] In one or more embodiments the determining, via the oral characteristic data, the vertical displacement may include determining as a function of the shape of the soft palate of the patient whether a posterior edge of the soft palate is longer than a normal soft palate with between 3 and 5 millimeters of space between a posterior edge of the soft palate to a posterior wall of an oral pharynx of the patientand providing the vertical displacement of between 8 and 10 millimeters.

[0114] The oral characteristic data may include determining whether a posterior edge of the soft palate is longer than a normal soft palate and webbed, and wherein two millimeters or less of space exists between the soft palate and a posterior wall of an oral pharynx, providing at least 11 to 14 millimeters for the vertical displacement. Further, the oral characteristic data may provide a vertical displacement as a function of the shape of the soft palate of the patient includes determining whether the soft palate is one of short, normal, and long.

[0115] In one or more embodiments the lower dental tray is inclusive of a first vertical displacement bite pad on a left side of the lower dental tray and a second vertical displacement bite pad on a right side of the lower dental tray wherein a height of each of the first and second vertical displacement bite pads is determined according to the oral characteristic data, the oral characteristic data providing soft tissue data of the patient indicative of airway function.

[0116] In one or more embodiments, the lower dental tray couples to the upper dental tray via two connectors as elastic bands coupled to either side of the dental appliance via the button protrusions. The elastic bands can include a plurality of pairs of elastic bands, each pair being of different length and / or elasticity.

[0117] Some embodiments of a method may include, forming an upper dental appliance chassis including at least two plateaus for upper appliance button protrusions; forming a lower dental appliance chassis including at least two plateaus for lower appliance button protrusions and at least two plateaus for vertical displacement bite pads, and ultrasonic welding the button protrusions and bite pads.

[0118] In one or more embodiments, the method includes forming a dental appliance including the lower dental tray and an upper dental tray, each of the lower dental tray and the upper dental tray, the lower dental tray inclusive of the at least two vertical displacement bite pads and at least two lower appliance button protrusions, the upper dental tray inclusive of the at least two upper appliance button protrusions, the at least two lower appliance button protrusions and the at least two upper appliance button protrusions providing a forward mandibular position when two connectors are attached to connect the upper dental tray and the lower dental tray.

[0119] Another embodiment is directed to a system including a processor and a non-transitory computer-readable storage medium storing instructions operative when executed on the processor to perform a method including receiving oral characteristic data of a patient, processing the oral characteristic data in a server to determine dentition data, a vertical displacement and a forward mandibular position to enable the patient to breathe during sleep by opening an airway of the patient; forming a dental appliance using the dentition data and the forward mandibular position, the dental appliance including a lower dental tray and an upper dental tray, each of the lower dental tray and the upper dental tray being homogeneous, the upper dental tray including a pair of upper dental tray plateaus, the lower dental tray including a pair of lower dental tray plateaus, ultrasonically welding a first pair of button protrusions onto the pair of lower dental tray plateaus; and ultrasonically welding a second pair of button protrusions onto the upper dental tray plateaus to provide the homogeneous dental appliance with the first pair of button protrusions and the second pair of button protrusions providing the forward mandibular position when two connectors are attached to connect the upper dental tray to the lower dental tray.

[0120] Those having skill in the art will recognize that the state of the art has progressed to the point where there is little distinction left between hardware and software implementations of aspects of systems; the use of hardware or software is generally (but not always, in that in certain contexts the choice between hardware and software can become significant) a design choice representing cost vs. efficiency tradeoffs. Those having skill in the art will appreciate that there are various vehicles by which processes and / or systems and / or other technologies described herein can be effected (e.g., hardware, software, and / or firmware in one or more machines or articles of manufacture), and that the preferred vehicle will vary with the context in which the processes and / or systems and / or other technologies aredeployed. For example, if an implementer determines that speed and accuracy are paramount, the implementer may opt for a mainly hardware and / or firmware vehicle; alternatively, if flexibility is paramount, the implementer may opt for a mainly software implementation that is implemented in one or more machines or articles of manufacture; or, yet again alternatively, the implementer may opt for some combination of hardware, software, and / or firmware in one or more machines or articles of manufacture. Hence, there are several possible vehicles by which the processes and / or devices and / or other technologies described herein may be effected, none of which is inherently superior to the other in that any vehicle to be utilized is a choice dependent upon the context in which the vehicle will be deployed and the specific concerns (e.g., speed, flexibility, or predictability) of the implementer, any of which may vary. Those skilled in the art will recognize that optical aspects of implementations will typically employ optically-oriented hardware, software, and or firmware in one or more machines or articles of manufacture.

[0121] The foregoing detailed description has set forth various embodiments of the devices and / or processes via the use of block diagrams, flowcharts, and / or examples. Insofar as such block diagrams, flowcharts, and / or examples contain one or more functions and / or operations, it will be understood by those within the art that each function and / or operation within such block diagrams, flowcharts, or examples can be implemented, individually and / or collectively, by a wide range of hardware, software, firmware, or virtually any combination thereof. In one embodiment, several portions of the subject matter described herein may be implemented via Application Specific Integrated Circuitry (ASICs), Field Programmable Gate Arrays (FPGAs), digital signal processors (DSPs), or other integrated formats. However, those skilled in the art will recognize that some aspects of the embodiments disclosed herein, in whole or in part, can be equivalently implemented in integrated circuitry, as one or more computer programs running on one or more computers (e.g., as one or more programs running on one or more computer systems), as one or more programs running on one or more processors (e.g., as one or more programs running on one or more microprocessors), as firmware, or as virtually any combination thereof, and that designing the circuitry and / or writing the code for the software and or firmware would be well within the skill of one of skill in the art in light of this disclosure. In addition, those skilled in the art will appreciate that the mechanisms of the subject matter described herein are capable of being distributed as a program product in a variety of forms, and that an illustrative embodiment of the subject matter described herein applies regardless of the particular type of signal bearing medium used to actually carry out the distribution. Examples of a signal bearing medium include, but are not limited to, the following: a recordable type medium such as a floppy disk, a hard disk drive, a Compact Disc (CD), a Digital Video Disk (DVD), a digital tape, a computer memory, etc.; and a transmission type mediumsuch as a digital and / or an analog communication medium (e.g., a fiber optic cable, a waveguide, a wired communications link, a wireless communication link, etc.).

[0122] In a general sense, those skilled in the art will recognize that the various aspects described herein which can be implemented, individually and / or collectively, by a wide range of hardware, software, firmware, or any combination thereof can be viewed as being composed of various types of "electrical circuitry." Consequently, as used herein "electrical circuitry" includes, but is not limited to, electrical circuitry having at least one discrete electrical circuit, electrical circuitry having at least one integrated circuit, electrical circuitry having at least one application specific integrated circuit, electrical circuitry forming a general purpose computing device configured by a computer program (e.g., a general purpose computer configured by a computer program which at least partially carries out processes and / or devices described herein, or a microprocessor configured by a computer program which at least partially carries out processes and / or devices described herein), electrical circuitry forming a memory device (e.g., forms of random access memory), and / or electrical circuitry forming a communications device (e.g., a modem, communications switch, or optical-electrical equipment). Those having skill in the art will recognize that the subject matter described herein may be implemented in an analog or digital fashion or some combination thereof.

[0123] Those having skill in the art will recognize that it is common within the art to describe devices and / or processes in the fashion set forth herein, and thereafter use engineering practices to integrate such described devices and / or processes into data processing systems. That is, at least a portion of the devices and / or processes described herein can be integrated into a data processing system via a reasonable amount of experimentation. Those having skill in the art will recognize that a typical data processing system generally includes one or more of a system unit housing, a video display device, a memory such as volatile and non-volatile memory, processors such as microprocessors and digital signal processors, computational entities such as operating systems, drivers, graphical user interfaces, and applications programs, one or more interaction devices, such as a touch pad or screen, and / or control systems including feedback loops and control motors (e.g., feedback for sensing position and / or velocity; control motors for moving and / or adjusting components and / or quantities). A typical data processing system may be implemented utilizing any suitable commercially available components, such as those typically found in data computing / communication and / or network computing / communication systems.

[0124] Referring now generally to FIGS. 8-16B, in accordance with another aspect of the invention, an improved dental appliance assembly 800 is provided for controlling forward mandibular advancement of a patient wearing the improved dental appliance assembly.

[0125] Referring now particularly to FIG. 8, the improved dental appliance assembly 800 may include: a lower dental tray 802b having left and right button protrusions 806b extending, or projecting, outwardly from respective left and right sides 804b, or exterior surfaces, of the lower dental tray 802b;an upper dental tray 802a having left and right button protrusions 806a extending, or projecting, outwardly from respective left and right sides 804a of the upper dental tray 802a;a first (e.g., left) dental strap 820 having reinforced openings 822c, 822d at opposite ends 822a, 822b of a dental strap body 822; and a second (e.g., right) dental strap 820 having reinforced openings 822c, 822d at opposite ends 822a, 822b of a dental strap body 822. Optionally, the lower dental tray 802b may have a pair of left and right vertical bite pads 810b extending, or projecting, upwardly from an upper surface 808b of the lower dental tray 802b.

[0126] Referring now particularly to FIG. 9, when the left and right dental straps 820 are assembled to the respective left and right sides, or exterior surfaces 804b, 804 of the respective lower and upper dental trays 802b, 802a, the reinforced openings 822c, 822d in the left and right dental straps 820 are sized and shaped to receive the button protrusions 806a, 806b therethrough in a first dental strap orientation (e.g., a horizontal orientation (see FIGS. 11A and 11 B) parallel to a corresponding horizontal orientation of the button protrusions 806a, 806b, and subsequently form a frictional fit between the reinforced dental strap openings 822c, 822d and the button protrusions 806a, 806b when the dental straps 820 are rotated into a second dental strap orientation (e.g., see a FIG. 11 C). Although the dental strap 820 in FIG. 11 C is shown rotated 90°, in practice, the dental straps 820 in the fully-assembled dental appliance are typically angularly rotated within a range of approximately 30° to 60° from the initial horizontal orientation.

[0127] Turning briefly to FIG. 12, in accordance with one or more embodiments, the left and right button protrusions 806a, 806b may include: a base portion 806d projecting outwardly from exterior surfaces 804a, 804b of the left and right sides of the upper and lower dental trays 802a, 802b; a distal end portion 806c terminating at an upper surface 806f, as shown in FIG. 11 C; and a central portion 806e adjoining the base portion 806d and the distal end portion 806c. Preferably, the central portion 806e is in the form of a reduced-diameter, recessed neck capable of partially receiving an exposed (i.e., non-overmolded) portion of a locking member 830 between the base portion 806d and the distal end portion 806c of the respective button protrusions 806a, 806b.

[0128] Referring briefly to FIGS. 10A and 10B, in at least one embodiment, the locking member 830 may be in the form of a solid circular disk having a central opening 838 extending completely therethrough. The circular shape is defined by perimeter edge 836, which adjoins opposite front and rear surfaces 832, 834. The central opening 838 may have an oblong shape defined by opposinginterior linear sides 838c, 838d defining a central opening length Li there between, and opposing interior concave sides 838a, 838b adjoining the opposing interior linear sides 838c, 838d and having an increasing distance therebetween from the interior linear sides 838c, 838d to midpoints of the opposing interior concave sides 838c, 838d, thereby defining a maximum central opening width Wi there between.

[0129] Referring now particularly to FIGS. 11A and 11 B, in accordance with one or more embodiments, each dental strap 820 may include: a pair of locking members 830 constructed from a first thermoplastic material having a first durometer; and a dental strap body 822 constructed from a second thermoplastic material having a second durometer less than the first durometer of the first thermoplastic, and having opposite dental strap body ends 822a, 822b with openings 825a, 825b extending completely therethrough. Peripheral portions of each locking member 830 are overmolded with a second thermoplastic material, and the central opening 838 of each locking member 830 is concentric with a corresponding one of the openings 825a, 825b at the opposite ends 822a, 822b of the dental strap body 822.

[0130] The central opening 838 of each one of the pair of overmolded locking members 830 is sized and shaped to snugly receive the distal end portion 806c of a corresponding button protrusion 806a, 806b therethrough in a first, unlocked dental strap orientation (e.g., a horizontal orientation as shown in FIGS. 11 A and 11 B). In this initial unlocked dental strap orientation, the distal end portions 806c of the respective button protrusions 806a, 806b have the same footprint as the central openings 838 of the partially overmolded locking members 838 but are slightly smaller in size to enable the distal end portions 806c of the button protrusions 806a, 806b to be received through the central openings 838.

[0131] Subsequently, a frictional fit may be formed between the locking member central opening 838 and the central portion 806e of the corresponding button protrusion when the dental strap 820 is rotated (A) thereabout into a second, locked dental strap orientation as shown in FIG. 11 C. It should be noted that the extreme (90°) angular rotation (A) shown in FIG. 11 C is exaggerated for clarity. In actual practice, the dental strap 820 is typically rotated within a range of approximately 15° to 75° -- and 30° to 60° -- from the initial horizontal (0°) orientation.

[0132] More specifically, as the dental strap 820 is rotated about a corresponding button protrusion 806a, 806b, the opposing interior concave sides 838a, 838b of the central opening 838 of the respective locking member 830 engage the exterior surface of the central portion 806e of the corresponding button protrusion to form a tight friction fit therebetween, such that the reinforcedopenings 822c, 822d at the opposite ends 822a, 822b of the dental strap 820 become positionally locked vis-a-vis the button protrusions 838a, 838b.

[0133] In accordance with one or more embodiments, the button protrusions 806a, 806b and corresponding dental trays 802a, 802b may be integrally formed into a homogenous, monolithic structure using a milling process, an injection molding process, or a 3D printing process.

[0134] In accordance with one or more embodiments, the homogenous, monolithic structure of the dental tray and integral button protrusions 806a, 806b may be constructed by milling a solid material “puck” made from an FDA approved materials such as, for example: an ethylene propylene copolymer, a polyoxymethylene copolymer, a thermoplastic olefin, a thermoplastic polyolefin, or an olefinic thermoplastic elastomer.

[0135] In accordance with one or more embodiments, the homogeneous, monolithic structure of the dental trays 802a, 802b and integral button protrusions 806a, 806b may be constructed by injection molding an appropriate material such as, for example, thermoplastics, thermoplastic elastomers, and the like.

[0136] In accordance with one or more embodiments, the homogeneous, monolithic structure of the dental trays 802a, 802b and integral button protrusions 806a, 806b may be constructed by 3D printing an appropriate material such as, for example, thermoset polymers (e.g., light polymerizable liquid materials) and cross linked polymers (e.g., a polyurethane, a methacrylate, or a copolymer).

[0137] In accordance with one or more embodiments, the homogenous, monolithic structure of the lower dental trays 802a, 802b may include integrally formed mandibular bite pads 810b projecting vertically upwards from an upper surface 808b thereof.

[0138] In accordance with one or more embodiments, the first durometer of the first thermoplastic material used to construct the locking members 830, and the second durometer of the second thermoplastic material used to construct the dental strap body 822 are both within a range of 55 Shore A and 115 Shore A.

[0139] In accordance with one or more embodiments, the first thermoplastic material used to construct the locking members 830 has first durometer that is at least 20 points Shore A greater that the second durometer of the second thermoplastic material used to construct the dental strap body 822 partially overmolding the locking members.

[0140] In accordance with one or more embodiments, the first thermoplastic used to construct the locking members 830 has a first durometer of at least 100 Shore A, and the second thermoplastic usedto construct the dental strap body 822 partially overmolding the locking members has a second durometer within a range of 55 Shore A to 90 Shore A.

[0141] In accordance with another aspect of the invention, an improved method is provided for constructing a dental strap 820 of a dental appliance assembly 800 for controlling forward mandibular advancement of a patient wearing the dental appliance assembly. Initially, a first thermoplastic material is injected molded to form a pair of locking members 830 having a first durometer, or hardness. Subsequently, a second thermoplastic material is injected molded to form a dental strap body 822 having a second durometer, or hardness, that is less than the first durometer / hardness of the locking members 830; preferably, at least 20 points Shore A less than the first durometer / hardness of the locking members 830. Significantly, the second thermoplastic used to form the dental strap body 822 overmolds perimeter portions 823a, 823b of each one of the pair of locking members 830 at the opposite strap body ends 822a, 822b. The partially overmolded locking members form the reinforced openings 822c, 822d at the opposite strap ends 822a, 822b.

[0142] In accordance with one or more embodiments, the first injection molded thermoplastic used to form the pair of locking members 830 is a polyethylene terephthalate (PTE).

[0143] In accordance with one or more embodiments, the second injection molded thermoplastic material used to form the dental strap body 822 partially overmolding the pair of pair of locking members 830 is a glycol-modified polyethylene terephthalate (PETG).

[0144] In accordance with one or more embodiments, the method of injection molding the first and second thermoplastic materials may comprise overmolding of polyethylene terephthalate (PTE) with thermoplastic elastomer (TPE), wherein the PTE is a glycol-modified polyethylene terephthalate (PETG).

[0145] In accordance with one or more embodiments, the method of injection molding the first and second thermoplastic materials may comprise injection overmolding the first thermoplastic material with a thermoplastic elastomer (TPE) material, thereby forming a chemically bonded material of a copolyester and a TPE.

[0146] As will be apparent to those skilled in the art, a locking member, or reinforcement member, having a different perimeter shape and / or central opening shape may be substituted for the locking member 830 previously described herein, and shown in FIGS. 10A and 10B, without departing from the intended scope of the invention.

[0147] Referring now particularly to FIGS. 14A and 14B, in accordance with an alternate embodiment, a locking member 850 is provided having opposite front and rear surfaces 852, 854 adjoined by a perimeter edge 856 defining an irregular, non-circular, locking member shape.Furthermore, a central opening 858 extending completely through the locking member 850 may have a “bowtie” shape defined by opposing linear sidewalls 858c, 858d adjoined at opposite ends by irregularly shaped opposing sidewalls 858a, 858b. Furthermore, the overmolded perimeter portion of the locking member 850 may incorporate one or more apertures 860, 862. For example, such apertures may provide an improved, more secure, attachment of the locking member 850 to the dental strap body 822. More specifically, when the second thermoplastic material is injected molded, the volume of the second thermoplastic overmolding the perimeter portion of the locking member 850 may fill, or pass through, at least a portion of at least one of the apertures 860, 862 to thereby reduce the risk of the overmolding delaminating from, or losing adhesion to, the locking member 850

[0148] Referring now particularly to FIGS. 15A and 15B, in accordance with an alternate embodiment, a button protrusion 870 is provided having an elliptically shaped base portion 876, a “bowtie” shaped upper portion 874, and a cylindrical central portion 873 adjoining the base portion 876 and the upper portion 874. For example, the upper portion 874 of the button protrusion 870 may have a “bowtie” shape matching the “bowtie” shape of the central opening 858 of the locking member 850, to enable the button protrusion to be snugly received through the central opening 858 of the locking member. In this manner, upon rotating an end portion 882c, 882d of the elastic band body 882 about the central portion 873 of the button protrusion 870, projecting portions 874 of the button protrusion 870 (i.e., the “bowtie” portions projecting radially outward of the cylindrical center portion 872) frictionally engage the exposed exterior surface of the locking member 850 to effectively fix the orientation of the dental strap 880 in a locked position vis-a-vis the button protrusion 870.

[0149] Since many modifications, variations, and changes in detail can be made to describe preferred embodiments of the invention, it is intended that all matters in the foregoing description and shown in the accompanying drawings be interpreted as illustrative and not in a limiting sense. Thus, the scope of the invention should be determined by the appended claims and their legal equivalence.

Claims

CLAIMSWhat is claimed is:1 . A dental appliance assembly (800) for controlling forward mandibular advancement while being worn by a patient, the dental appliance assembly comprising: a lower dental tray (802b) having a pair of protrusions (806b) extending outwardly from opposite left and right sides (804b) thereof; an upper dental tray (802a) having a pair of protrusions (806a) extending outwardly from opposite left and right sides (804a) thereof; a left dental strap (820) having a pair of reinforced openings (822c) at opposite ends (822a, 822b) thereof; and a right dental strap (820) having reinforced openings (822c, 822d) at opposite ends (822a, 822b) thereof, wherein when the left and right dental straps (820) are attached to the opposite left and right sides (804b, 804a) of the lower and upper dental trays (802b, 802a), the reinforced openings (822d, 822c) in the left and right dental straps (820) are sized and shaped to receive corresponding button protrusions (806a, 806b) therethrough in a first dental strap orientation, and subsequently form a frictional fit between the reinforced dental strap openings (822d, 822c) and the button protrusions (806a, 806b) when the dental straps (820) are rotated about the button protrusions into a seconddental strap orientation.

2. The dental appliance assembly (800) recited in claim 1 , wherein each one of the button protrusions (806a, 806b) extending outwardly from the left and right sides (804a, 804b) of the upper and lower dental trays (802a, 802b) further comprises: a base portion (806d) protruding outwardly from one of the left and right sides (804a, 804b) of one of the upper and lower dental trays (802a, 802b); a distal end portion (806c); and a central portion (806e) adjoining the base portion (806d) and the distal end portion (806c).

3. The dental appliance assembly (800) recited in claim 2, wherein each dental strap (820) further comprises: a pair of locking members (830) constructed from a first thermoplastic material having a first durometer; a dental strap body (822) constructed from a second thermoplastic material having a second durometer less than the first durometer of the first thermoplastic, opposite ends (822a,extending completely therethrough; wherein a peripheral portion (823a, 823b) of each locking member (830) is overmolded with the second thermoplastic material, and each locking member (830) has a central opening (838) extending completely therethrough and concentric with a corresponding one of the reinforced openings (825a, 825b) at opposite ends (822a, 822b) of the dental strap body (822), and wherein the central opening (838) of each overmolded locking member (830) is sized and shaped to snugly receive the distal end portion (806c) of one of the button protrusions (806a, 806b) therethrough in a first, unlocked dental strap orientation, and subsequently form a frictional fit between the locking member central opening(838) and the central portion (806e) of one of the button protrusions (806a, 806b) when the dental strap body (822) is angularly rotated about the central portion (806e) of one of the button protrusions (806a, 806b) into a second, lockeddental strap orientation.

4. The dental appliance assembly (800) recited in claim 3, wherein the dental strap body (822) is angularly rotated within a range of 30° to 60° into the second, locked dental strap orientation.

5. The dental appliance assembly recited in claim 3, wherein the button protrusions (806a, 806b) are sonically welded onto an exterior surface (of one of the left and right sides of one of the upper and lower dental trays, wherein ultrasonic energy used during sonic welding generates interfacial heating between the base portions(806d) of the button protrusions(806a, 806b) and button protrusion attachment plateaus (330, 332) on opposite sides of the respective upper and lower dental trays (310, 320), thereby forming an interfacial weld between the base portions (806d) and the button protrusion attachment plateaus (330, 332) upon cooling.

6. The dental appliance assembly (800) recited in claim 3, wherein the button protrusions (806a, 806b) and corresponding upper and lower dental trays (802a, 802b) are integrally formed into homogenous monolithic structures, using one of: a milling process; an injection molding process; and a 3D printing process.

7. The dental appliance assembly (800) recited in claim 3, wherein the first durometer of the first thermoplastic material used to construct the locking members (830), and the second durometer of the second thermoplastic material used to construct the dental strap body (822) are both within a range of 55 Shore A to 115 Shore A.

8. The dental appliance assembly (800) recited in claim 7, wherein the first thermoplastic material used to construct the locking members (830) has a first durometer that is at least 20 points Shore A harder than the second durometer of the second thermoplastic material used to construct the dental strap body (822) partially overmolding the locking members (830).

9. The dental appliance assembly (800) recited in claim 8, wherein the first and second durometers of the respective first and second thermoplastic materials used to construct the respective locking members (830) and dental strap body (822) partially overmolding the locking members (830), are one of: a first durometer of at least 100 Shore A, and a second durometer of 55 Shore A; a first durometer of at least 100 Shore A, and a second durometer of 65 Shore A; a first durometer of at least 100 Shore A, and a second durometer of 80 Shore A; and a first durometer of at least 100 Shore A, and a second durometer of 90 Shore A.

10. A method of constructing a dental strap (820) for coupling upper and lower dental trays (802a, 802b) of a dental appliance assembly (800) for controlling forward mandibular advancement while being worn by a patient, comprising steps of: injection molding a first thermoplastic material to form a pair of locking members (830) having a first durometer / hardness; and injection molding a second thermoplastic material to form a dental strap body (822) having a second durometer / hardness, the dental strap body (822) overmolding a perimeter portion (823a, 823b) of each one of the pair of locking members (830), wherein the first durometer / hardness of the injection molded pair of locking members (830) is at least 20 points Shore A greater than the second durometer / hardness of the injection molded dental strap body (822).11 . The method recited in claim 10, wherein the first injection molded thermoplastic material used to form the pair of locking members (830) is a polyethylene terephthalate (PTE).

12. The method recited in claim 10, wherein the second injection molded thermoplastic material used to form the dental strap body (822) overmolding the pair of locking members (830) is a glycol-modified polyethylene terephthalate (PETG).

13. The method recited in claim 10, wherein the steps of injection molding the first and second thermoplastic materials further comprise:overmolding of polyethylene terephthalate (PTE) locking ring (830) material with thermoplastic elastomer (TPE) dental strap body (822) material, wherein the PTE is a glycol- modified polyethylene terephthalate (PETG).

14. The method recited in claim 10, wherein the steps of injection molding the first and second thermoplastic materials further comprises: injection overmolding the first thermoplastic material with a thermoplastic elastomer (TPE) material, thereby forming a chemically bonded material of a copolyester and a TPE.

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