DENTAL DEVICES

RELATED APPLICATIONS

[001] The present application claims priority to the U.S. Provisional Application Serial No. 62/365,970 filed July 22, 2016, by LIPTAK et al., and entitled "A COMPUTER AIDED DESIGN MATRIX FOR THE MANUFACTURE OF ORAL APPLIANCES," the entire disclosure of which, including any drawings, is incorporated by reference herein.

FIELD OF THE INVENTION

[002] The present invention is in the field of dental devices. In particular, the present invention is in the field of a computer aided design procedure for preparing a design and manufacturing a dental device.

BACKGROUND OF THE DISCLOSURE

[003] The use of dental devices to treat sleep apnea is well-known in the art. These devices use several different techniques for moving the mandible forward when the device is worn, in order to open the patient's airway, particularly during the sleep hours, and thereby reduce the occurrence of sleep apnea. In addition, health care providers, patients, and manufacturers have a wide variety of options in choosing the style of the device, the material with which the device is made, and accessories used with the device. These options are generally determined by the patient anatomy, patient comfort, health care provider bias, and the manufacturing ease.

[004] Currently, dental devices are hand-crafted artisanally to the health care provider's specification. Each laboratory or medical device manufacturer is capable of manufacturing one type, or at most, a select few of the options. If different styles of mandibular advancement devices, or combination of mandibular advancement devices with other splints utilizing the same patient data, are desired then the patient or the health care provider must contact multiple laboratories. Accordingly, currently it is economically impossible to prepare multiple sets of devices for a patient. As the result, in many cases the patient is not receiving the device that is the best fit for their needs. SUMMARY OF THE INVENTION

[005] Disclosed herein are methods of manufacturing dental devices, the method comprising: obtaining a set of clinical options for the dental devices from a health care provider in the form of a prescription herein referred to as the "Rx," which includes the treatment plan for the patient; creating a first data set from the set of clinical options; communicating the data set to a computer aided design (CAD) software; preparing a digital design for the dental devices using the CAD software; communicating the digital design to an automated milling apparatus; and automatedly milling a block of polymer to obtain the dental device. Also disclosed are dental devices manufactured by the above method. Further disclosed are methods of treating or ameliorating sleep apnea or a jaw-related disorder in a patient, the method comprising obtaining a dental device manufactured by the above method and positioning the dental device over the dentition prior to sleep, whereby the mandible is advanced forward, vertically, laterally or a combination of the three, relative to the maxilla, thereby ameliorating the symptoms of sleep apnea or the jaw -related disorder.

DETAILED DESCRIPTION OF THE EMBODIMENTS

[006] The present disclosure is directed to a method of obtaining information about a patient's dentition and the preferences of the patient and/or a health care provider in order to manufacture a set of dental appliances that match the patient's needs. Previously, embodiments of a particular dental appliance, namely a mandibular advancement device, have been disclosed. See, for example, the International Publication WO 2015/103084 (the entirety of this publication, including all the drawings, is incorporated herein by reference, in particular the following sections describing the device and the methodology of titration: Paragraphs [0019]-[0053] and FIGs. 1A-4E and 7-9). The methods and products disclosed herein are used in connection with the device described in the above-incorporated document, or any other device that is currently on the market, or other novel combinations of devices and accessories.

[007] While the methodology disclosed herein can be practiced through numerous different, and varied, steps, the steps can be thought of as falling into at least three separate, yet connected, stages. First, a health care provider (HCP) examines the patient and obtains an impression of the patient's dentition, and models the bite by taking a bite impression in one or more positions of the mandible relative to maxilla. The relative position of the jaw bones also includes the position of the condyle in the mandibular fossa. The impressions can be taken traditionally with dental impression material and poured up in stone either at the HCP office or at the manufacturing laboratory or site (MFG). Additionally, the HCP may digitally capture the patient dentition, bite (for example relative bite position) and anatomy and send the resulting data set to the MFG. The HCP may also capture the position of the mandible relative to the maxilla at several positions such that a range of motion can be modelled from which an ideal new position for the mandible, which was not captured in the clinic, can be created in the CAD software. In some embodiments, the HCP also captures data regarding the patient's anatomy. These data may include cone beam computer tomographic (CBCT) images of the temporomandibular joint (TMJ), facial landmarks, airway anatomy, and the like.

[008] Then, based on the patient's needs and anatomy, the HCP selects several clinical options, discussed fully below, for the particular device of interest for the patient. Second, the HCP communicates these clinical options to the MFG. The MFG creates a computer aided design (CAD) of the device, having the selected clinical options. Third, the design is communicated to an automated manufacturing machine, which creates the selected device from a block of an appropriate material. Other machines can then install other accessories that cannot be manufactured as a single contiguous unit along with the device. The CAD process may create several devices from the same data set, each device designed to serve a different aspect of the treatment plan, such as nighttime treatment of sleep apnea or bruxing, or daytime treatment for pain relief or aesthetics, where the device places the mandible in a different position relative to the maxilla for a specific outcome related to the treatment plan.

[009] In some embodiments, the block is made up of a solid material. In certain embodiments, the block is a polymeric block. In other embodiments, the block is made of a natural substance, for example metal, wood, natural resin, natural rubber, and the like. In other embodiments, the block is made of synthetic polymeric material, having either one type of monomer or two or more co-polymers.

[0010] The automated fashion by which the dental devices are prepared allow for a multitude of different devices, having different features, to be prepared rapidly and economically, where the devices are identically manufactured. This allows for the patient and the HCP to experiment with a number of different option to see which one fits the patient's mouth and dentition better. This process cannot be effectively done using the current technologies because the current dental devices are prepared artisanally by hand, which introduces variations into the manufactured devices, even when they are prepared from the same exact set of requirements.

[0011] Thus, in one aspect, disclosed herein are methods of manufacturing a dental device, the method comprising:

- obtaining a set of clinical options from a HCP;

- creating a first data set from the set of clinical options;

- communicating the data set to a computer aided design (CAD) software;

- preparing a digital design for the dental device using the CAD software;

- communicating the digital design to an automated manufacturing apparatus; and

- automatedly manufacturing the dental device.

[0012] In some embodiments, the steps of preparing the digital design, communicating the design with the manufacturing apparatus, and manufacturing the device, are repeated for each of the desired devices. In some of these embodiments, however, the same patient data set is used to manufacture the multitudes of devices. In some embodiments, the several devices are used in sequence. For instance, if the mandibular repositioning is meant to include repositioning in various directions, one device may be used to reposition the mandible from a first to a second position, a second device is used to reposition the mandible from the second to a third position, and etc.

[0013] In some embodiments, the HCP is a dentist. In other embodiments, the HCP is a dental technician. In other embodiments, the HCP is a sleep disorder specialist. In certain embodiments, the HCP is an individual charged with altering the position of the patient's mandible (e.g., the use of mandibular advancement devices). In other embodiments, the HCP is an individual charged with straightening a patient's teeth (orthodontia) (e.g., the use of braces and the like. In other embodiments, the HCP is a Temporal Mandibular Joint (TMJ) and Disease (TMD) specialist who repositions the mandible to manage pain. In certain embodiments, the patient is a human.

[0014] In some embodiments, the presently disclosed methods produce a mandibular advancement device that is worn at night during sleep, while in other embodiments, additional or singular devices are designed to be worn during the day. In still other embodiments, the device can be used 24 hours a day. Dentition Impression

[0015] Obtaining the data regarding the shape of the patient' s dentition is well- known to those of ordinary skill in the art. In some embodiments, the HCP obtains the dentition impression using trays filled with impression materials. The impression is then used to create a plaster model identical to the patient's dentition.

[0016] In some embodiments, the HCP provides photographs of the patient's dentition. A computerized three-dimensional (3D) image of the patient's dentition can then be prepared. In some embodiments, the patient's dentition is scanned, for example with an intraoral scanner, while in other embodiments, the plaster model of the patient's dentition is scanned. The scanning data is used to create a computerized 3D image of the patient's dentition.

[0017] A clinically obtained data set can be obtained from the patient' s anatomy using techniques such as, but not limited to, X-ray imaging, dental impressions, intraoral scanning, cone bean computed tomography (CBCT), palpitations of the area around the jaws, visual inspection of the dentition, or patient testimony. The term "anatomy" includes any patient data that refers to hard or soft tissue, or specific features that describe that tissue, that may include well known landmarks such as molar cusps, height of contour, anatomical planes, facial landmarks or descriptive values such as arch shape, tongue size, or Malampatti score and the relationship between the hard and soft tissue to appearance or function. The data set is then used to create a patient specific prescription that is precisely implemented into the treatment device via a CAD/CAM platform and/or a matrix-generated prescription of various option, such as the one disclosed in U.S. Patent Application Serial No. 15/416,715, the entire disclosure of which, including any drawings, is incorporate by reference herein.

[0018] In some embodiments, patient testimony includes descriptions of symptoms related to sleep breathing disorders, such as sleep apnea, snoring, upper airway resistance syndrome (UARS) or symptoms related to malpositioning of the mandible affecting the patency of the airway or discomfort at the temporal mandibular joint (TMJ) realized as temporal mandibular disorder (TMD). The mandible is capable of being positioned in the anterior-posterior direction (AP), being positioned in the vertical dimension (perpendicular to the occlusal plane), or rotate around an axis contained in the occlusal plane. Sometimes the comparison to an airplane or a ship having the three axes of rotation of pitch, yaw, and roll is a useful analogy. [0019] In some embodiments, an HCP provides instructions based on the current position of the patient's mandible and a desired treatment position. The desired treatment position can be determined by many methods, including positioning the mandible in an open and protruded position using a George Gauge, ProGauge, Airway Metrics or other like gauges. Additionally, there are methods that use enunciation of numbers such as "sixty six" to provide a guide for a treatment position. The HCP can also use airway analysis using CBCT software in the two positions (current and desired), evaluate the alignment of the condyle in the fossa for TMJ positioning or use X-ray imaging for anatomical measurements. For example, the position of the condyles for the left and right side of the patient could be measured relative to an established healthy position. In other embodiments, the HCP may also find an optimal position for the mandible using heart rate variability, or other systemic body variables. The difference in the left and right positions relative to the treatment position can then be documented and written into the prescription creating the proper protrusion (symmetrical or asymmetrical), vertical repositioning, and any other angular components of the mandibular position. The positioning of the mandible may also meet patient needs concerning the aesthetics of the face and the impact of a new mandibular position to the look of the face.

Selecting Clinical Options

[0020] The set of clinical options is prepared based on the HCP' s determination of what is required and/or most effective for the treatment of the patient. Thus, the set of clinical options is at times referred to as the "prescription" or "Rx" that the HCP provides for the treatment of the patient.

[0021] Throughout the present disclosure, the word "option" or the phrase "clinical option" as it relates to the selectable options for a dental device, refers to a category of features. For example, titration option refers to the category of available titration features. Titration options serve to create the method of advancement of the mandible relative to the maxilla. Each particular feature under an option is a "selection." Thus, the HCP chooses a selection under an option.

[0022] After examining the patient's dentition and oral anatomy, the HCP obtains information regarding the shape of the patient's dentition or the range of motion of the patient's jaw. The range of motion includes, but is not limited to, rotational and translational movements of the mandible, such as protrusive movement, vertical movement, lip competency (i.e., the extent a person can separate their jaws while keeping the lips closed), or golden proportions (i.e., the aesthetically accepted ratios of teeth size to facial dimensions and symmetry). Commonly, this is done by generating an imprint of the dentition on a polymer or dental impression material. In other embodiments, the data regarding the shape the dentition is obtained by analyzing photographs of the dentition, or by a machine reading the contours of the dentition.

[0023] Next, the HCP selects a series of clinical options for the dental device. These clinical options relate to the material that makes up the dental device, the mechanism of titration, and other physical features of the device. These clinical options are described in detail below.

[0024] In some embodiments, the selection of the clinical options is through a web portal. In these embodiments, a website is provided for the HCP to communicate the clinical options with the MFG. In some embodiments, the website provides a questionnaire where the HCP provides a written response to questions relating to each option. In other embodiments, the clinical options are listed with a radio button next to each. The HCP chooses the desired option by clicking on the appropriate radio button. In yet other embodiments, the HCP selects the desired option from a drop-down window, listing all the available selections for that particular option.

[0025] In some embodiments, the selection of options is intelligently organized. By "intelligent organization" it is meant that when the HCP makes an initial selection, then only groups of subsequent options that create a viable device within the initial selection are enabled. For example, selecting elements of contradictory, weak or unsafe designs are not allowed. The final grouping of the selections along with the patient information and HCP's approval culminate in the prescription. In certain embodiments, the intelligent organization of the selection options include the availability of only those options for a particular selection that comply with regulatory requirements.

[0026] In some embodiments, the set of clinical options comprise two or more clinical options selected from the group consisting of titration mechanisms, titration accessories, splint design, retention mechanisms, splint material, and fin or strap design or sleeve (e.g., a covering for a fin). In certain embodiments, the clinical options include other features not enumerated herein.

[0027] "Titration" is the process of adjusting the relationship between the mandible and the maxilla for a desire outcome (also referred to as "calibration"), such as relief of symptoms due to obstructive sleep apnea (OS A). Currently, examples of the titration techniques include the threaded screw system on a device, where the patient or the HCP adjust or turn a small screw, which causes a portion of the dental device to move to a position dictated by the HCP (U.S. Patent No. 6,604,527); or changing of straps of different lengths (U.S. Patent No. 5,365,945). A novel method of titration is disclosed in the above- incorporated International Publication WO 2015/103084. Portions of the disclosure of the publications listed in this paragraph related to the adjustment mechanism are incorporated by reference herein.

[0028] "Retention" is the process of fitting a device to the dentition, such that the device has a tight enough fit to be efficacious, yet has a loose enough fit to be comfortably worn by the patient. Retention may also be optimized to minimize the amount of tooth movement or bite changes caused by wearing a device the imparts forces on the teeth and relative position of the mandible and maxilla to each other.

[0029] "Titration mechanism" is a component or property of the device, that through adjustment, the upper and lower arch splint relative position can be affected to achieve a patient outcome. For each mechanism, a number of "titration accessories" is available, by way of which the titration is carried out. These accessories are projections or additions attached to a basic splint. In some embodiments, the titration accessory is selected from the group consisting of an electronic or microelectronic device, a "smart" accessory (i.e., an electronic device that obtains data and communicates the data with another electronic device), affixed sleeve, removable sleeve, straps, anterior hinge, short or long Herbst hinge, jack screw, and Herbst hinge in combination with jack screw, or any other appliance accessory now known or designed in the future. In some embodiments, the accessory is separately manufactured from that of the base dental device. In these embodiments, the accessory itself is attached to the device after the manufacturing of the device. In other embodiments, the accessory is part of the unitary design of the device. In these embodiments, the accessory comes to being at the same time the device is manufactured. For example, a fin, a strap, a hinge, a screw, etc., and combinations thereof, are titration accessories.

[0030] In some embodiments, the titration mechanism is selected from the group consisting of microtitration series, jack screw titration, Herbst hinge titration, anterior hinge titration, strap titration, mechanical hook, and combinations thereof.

[0031] "Microtitration series" refers to the titration procedure disclosed in the above-incorporated International Publication WO 2015/103084, particularly in Paragraphs [0051]-[0061], which paragraphs are explicitly incorporated by reference herein. Through the use of the microtitration mechanism, a number of upper and lower splints having fins are manufactured for the patient. Each of the upper and lower splints has a different fin offset setting. The clinician chooses one set of upper and lower splints for the patient. If the patient's condition is not improved sufficiently, the clinician then chooses another set of splints. This process is continued until a set of splints providing the best clinical outcome is chosen. In one embodiment, the HCP may start with one titration mechanism and then switch one or both splints to incorporate another mechanism. For example, the upper arch could start with the "Jack Screw" and then be traded out for the microtitration upper splint, which has a lower profile and is more comfortable.

[0032] "Jack screw" (also known as "expansion screw") titration refers to a system of titration where the movable parts of the dental device are connected by a screw. A nut is provided, whereby the turning of the nut causes the movable parts to move with respect to each other so that the parts either come closer together or are moved further apart. An example of a jack screw titration is shown in FIGs. 15a and 15b of USP 6,604,527 and the corresponding discussion in the specification thereof (incorporated by reference herein).

[0033] "Herbst hinge titration" is well-known to the skilled artisan. The hinge comprises a smaller cylinder that fits within a larger cylinder. The user can determine the extent to which the smaller cylinder can extend out of the larger cylinder, thereby limiting the extent of separation of the two cylinders. When one cylinder is attached to, for example, an upper splint of an advancement device and the other cylinder is attached to the lower splint, then the two pieces can be separated by a prescribed distance. By lowering the distance, the user can titrate the device. A discussion of the Herbst device is found, for example, in Vela-Hernandez et al., J Clin Orthod. 2004 Nov;38(l l):590-9 ("Clinical management of the Herbst Occlusal Hinge appliance"). A Herbst hinge titration may also include a set of fixed bars that are swapped out for different protrusion levels.

[0034] In some embodiments, the titration mechanism is a hybrid mechanism. In these embodiments, two or more of the above mechanism, or in combination with other mechanism used in the art, are combined. An example of a hybrid titration mechanism would be the combination of microtitration series with expansion screw. An example of this type of a combination device is disclosed in Serial No. [006], incorporated by reference herein in its entirety, including the drawings. For instance, the fin location of one of the splints, e.g., upper or lower, is changed by replacing the splint, as in the microtitration series, while the fin location of the other of the splints is changed by the use of a screw. [0035] In some embodiments, once the HCP has determined the titration methodology, the HCP can then pick the desired titration accessory to affect the chosen methodology. In some embodiments, the titration accessory is selected from the group consisting of affixed sleeve, removable sleeve, straps, anterior hinge, short or long Herbst hinge, jack screw, Herbst hinge in combination with jack screw, and combinations thereof.

[0036] An "affixed sleeve" is a protrusion immovably attached to the dental device. The location of the protrusion on the splint, and more specifically the relative positions of the sleeves on the upper and lower splints of the dental device, are fixed. An example of the affixed sleeve embodiment is found, for example, in FIGs. 7 and 6 of USP 6,604,527 and the corresponding discussion in the specification thereof (incorporated by reference herein).

[0037] A "removable sleeve" is a covering that fits over an affixed fin on a splint of a dental device, thereby changing the thickness of the fin. Consequently, the relative positions of the upper and lower fins are changed and the two splints of the device are located at a different distance from each other than without the sleeve. A number of sleeves having different thicknesses can be prepared for each fin. An embodiment of the removable sleeve is disclosed in the US Provisional Application Serial No. 62/289,131, incorporated by reference herein, particularly Paragraphs [0015] -[0040] and the drawings.

[0038] A "strap" is a rubber or stretchable plastic band that connects the upper and lower splints of a mandibular advancement device, thereby providing mandibular advancement while allowing for a limited motion of the mandible. In some embodiments, the strap is elastic while in other embodiments, the strap is not elastic. In some embodiments, the strap is stretchable while in other embodiments, the strap is not stretchable. An example of a device using straps is the EMA ^® (Elastic Mandibular Advancement) oral appliance (Glidewell Laboratories, Newport Beach, CA). In some embodiments, the strap is a non- stretchable strap, for example as used with NARVAL™ CC (ResMed, San Diego, CA). In some embodiments, the strap is a link, which is a rigid, non-stretchable, strap, typically made from a rigid polymer or metal.

[0039] In some embodiments, the upper and lower splints of a dental device are connected by a frontal, or anterior, hinge. The relative openness of the hinge determines the extent of the device's opening. An example of a device using the anterior hinge is the TAP® (Thornton Adjustable Positioner) series of devices (Keller Lab, Fenton, MO).

[0040] While in some embodiments, the HCP chooses the titration methodology first and then chooses the titration accessory, in other embodiments, the HCP chooses the titration accessory first, and then based on the accessory chooses the titration methodology.

[0041] In some embodiments, the splint design is selected from the group consisting of a fin, anterior opening, anterior discluder, scalloped occlusal surface, lingual opening, a tapered posterior, a tongue attractor, lingualess, full lingual coverage, edentulous, posterior lingual, anterior lingual, anterior lingualess, and monoblock.

[0042] The devices worn by a patient comprise a dentition arc that fits over the patient's dentition. In some devices, the internal space of the arc is empty. In other words, in these devices the splint forms the shape of a "U." These devices are termed "lingualess" devices. (See, for example, SomnoDent® (SomnoMed®, Frisco, TX) and Micr0 ₂ ® ( ProSomnus®, Pleasanton, CA)). In other devices, the posterior portion of the splint, i.e., the ends of the "U" that cover the molars, are connected together to provide additional strength to the device. The anterior space remains empty. These devices are termed "anterior lingualess" devices. In some other devices, termed the "full lingual coverage" design, the splint lacks the empty middle section.

[0043] A "posterior lingual" or "partially lingual" design is defined as the design of a dental device that covers the posterior teeth and provides lingual coverage adjacent to the posterior teeth. In this design, the device does not cover the lingual or possibly the labial sides of the front teeth, e.g., the incisors. In some embodiments, the posterior lingual design has an anterior portion that fits behind the front teeth. In other embodiments, the design has no anterior component. The posterior lingual design exerts a different level of retention than other designs, which may be of greater comfort for some patients. This design also enables a structured contoured design, and/or increases the strength of the device while leaving the space behind the anterior teeth minimally covered or not covered at all.

[0044] An "anterior lingual" design is defined as the design of a dental device that provides lingual coverage adjacent to the anterior teeth. The anterior lingual design exerts a different level of retention than other designs, which may be of greater comfort for some patients. This design also enables a structured contoured design, and/or increases the strength of the device

[0045] "Edentulous" designs are used when the patient lacks a complete set of teeth. In an edentulous, or full edentulous, design, the patient has no teeth, and the device is designed for over the edentulous ridge, or for over the dentures. In a partially edentulous design, the device is designed to fit in the adventitious space between the teeth. Additionally, a fully edentuluous design can incorporate dental implant screws with buttons that snap into the device for retention.

[0046] In a "monoblock" design, the upper and lower splints are fused together in one piece. A series of monoblock splints can create protrusion increments similar to micro titration but with fused components.

[0047] In some embodiments, the retention mechanism is selected from the group consisting of implant-retained mechanisms, metallic ball clasps, plastic ball clasps, dental buttons, soft liner, and a hard acrylic polymer.

[0048] Several different materials can be used to make splints using the methods disclosed herein. In general, the splint material has one or more of the following attributes: the material has sufficient strength to move the mandible; the material's malleability and/or compressibility is less than 25% of the desired adjustment distance; the material does not disintegrate in the aqueous environment of the mouth; the material does not leave a repugnant taste in the user's mouth; the material is biocompatible with the patient's physiology; the material is strong enough to withstand the pressure exerted by the jaw bones during use; the material can be additively printed or manufactured and the material can be machine grinded into the desired shape. Some embodiments of methods of manufacturing are disclosed in U.S. Application Serial No. 15/416,715, the entire disclosure of which, including the drawings, and specifically Paragraphs [009]-[0059] of the specification as originally filed, are incorporated by reference herein.

[0049] In some embodiments, the splint material option is selected from the group consisting of standard polymethylmethacrylate (PMMA), lined PMMA, high- strength polyetheretherketone (PEEK), polymer produced from polyoxymethylene and acetal copolymers (Duracetal®), glycol modified polyethylene terephthalate (PETg), and a physiologically compatible, water insoluble, and non-maleable polymer. Other polymers meeting one or more of the general requirements also be used. In certain embodiments, the splint is made of metal or wood.

[0050] When a splint having fins is used, the anterior surface of an upper fin, i.e., the mesial surface of a fin on the splint for the upper jaw, contacts the posterior surface of a lower fin, i.e., the distal surface of a fin on the splint for the lower jaw. In some embodiments, the surfaces make an angle of about 90° with the patient's occlusal plane, while in other embodiments, the angle is obtuse, and in still other embodiments, the angle is acute. In some embodiments, the angle is 90°, while in other embodiments, the angle is between about 20° to about 80°, for example, an angle selected from the group consisting of about 20°, about 25°, about 30°, about 35°, about 40°, about 45°, about 50°, about 55°, about 60°, about 65°, about 70°, about 75°, and about 80°. In other embodiments, the angle is between about 100° to about 160°, for example, an angle selected from the group consisting of about 100°, about 105°, about 110°, about 115°, about 120°, about 125°, about 130°, about 135°, about 140°, about 145°, about 150°, about 155°, and about 160°.

[0051] Each one of these designs has a set of unique advantages that the HCP might find beneficial for the patient. The skilled artisan is familiar with the advantages. Thus, in some embodiments, the fin or strap design option is selected from the group consisting of, a normal fin, an acute fin, an obtuse fin, and straps in compression or traction setting.

[0052] In some embodiments, the set of clinical options further comprise an option selected from the group consisting of an open anterior, an anterior discluder, a scalloped occlusal surface, a lingual opening, a compliance chip, an AM positioner, a tapered posterior, a tongue attractor, a bruxism package, lingualess, full lingual coverage, edentulous, posterior lingual, anterior lingual, anterior lingualess, and monoblock.

[0053] In some embodiments, the HCP chooses a device having an open anterior. These embodiments, typically direct the HCP to shy away from choosing an anterior hinge. Anterior discluders, such as the Best-Bite™ discluder (Whip Mix, Louisville, KY), are well known in the art. If the HCP chooses to incorporate an anterior discluder, it can be modeled into the splint design and manufactured as a monoblock along with the splint.

[0054] In a device with "scalloped occlusal surface" the occlusal surface of the splint, for example the molar area, is contoured to match the occlusal surface of the dentition.

[0055] Devices with a "lingual opening" or "anterior opening" are devices that have an opening in the anterior portion of the device that allows for air to move in and out of the mouth even when the mouth is partially closed.

[0056] Some insurance companies require patient's in certain professions, for example long haul truck drivers, to show that the device is being used in compliance with the HCP's instructions. Some devices comprise an electronic microchip that records the date and time the device was in use and the date and time the device was not in use. The data from these "compliance chips" can then be downloaded and communicated with the insurance company or another monitoring agency. In some embodiments, where such compliance chip is required or recommended, HCP chooses to include the chip in the splint design. The automated manufacturing machine is then programmed to include a space for the chip. The chip can then be inserted either automatedly or manually.

[0057] Following the overnight use of a mandibular advancement device, the joints and muscles of the jaw may experience fatigue, spasms, and pain because the mandible has been held in a forward, unnatural position for several hours. An AM positioner, or a morning positioner, for example Good Morning Positioner (Space Maintainers Laboratories, Chatsworth, CA) will assist to restore the jaw in the proper position. In some embodiments, the HCP chooses to provide additional instructions for the design of an AM positioner, in addition to the instructions for the splint design, or independent of the splint design, as the same patient data would be used in the manufacturing of both devices.

[0058] When a foreign device is inserted into the mouth, subconsciously the mouth continues to explore the new device, leading to tongue fatigue, which in turn leads to the tongue falling back in the mouth and further aggravating or producing a sleep apnea condition. In addition, tongue exploration of the device can lead to more anterior tongue activity and protrusions. An attractor can promote this even further to enhance tongue protrusion and increase muscle tone for a more viable airway. By strategically positioning a tongue attractor, e.g., a dent, a boss, a ridged or rough surface, and the like, in the splint, the tongue seeks the attractor and stays in position over the attractor, reducing or eliminating tongue fatigue, and/or enhanced tongue protrusion. In some embodiments, either the lower or upper, or both, splint has organic shapes as part of the design to increase the natural feel and comfort of the device, and to also activate the tongue via proprioceptive pathways, which cause the tongue and/or the muscle structure surrounding the airway respond to keep the airway open leading to a reduction in airway related symptoms. In some embodiments, the tongue attractor is one or more tori located in the anterior portion of the splint.

[0059] Individuals with bruxism, i.e., night-time teeth grinding, regularly are prescribed a bruxism package, which comprises a mouth guard that will protect the teeth during the subconscious grinding. In some embodiments, where the patient suffers from bruxism in addition to sleep apnea, the HCP chooses to include a bruxism package with the splint design. In some embodiments, the bruxism package is designed from the same set of patient data provided from the HCP.

[0060] In some embodiments, the selection of certain embodiments of an option renders the selection of certain embodiments of another option moot. For example, if the HCP chooses to select Microtitration Series for the titration mechanism, then the HCP will not be permitted to choose a Herbst hinge for the titration accessories. Instead, only accessories associated with the Microtitration Series, for example fixed or removable fins, will be available. The "smart" Rx allows only combinations of features such as the titration mechanism or any other features of the design that meet the clinical and engineering requirements of making a safe and useful device. Combinations for the selected features are presented visually to the HCP for verification of their selection.

Data Handling

[0061] Once all the selections are made on the website, the HCP communicates the selections with the MFG by any method currently known in the art, or later developed, for sending data through a web portal, for example, by clicking on a "SEND" icon at the bottom of the page, and the like. At this point, the HCP may also transmit the data regarding the patient's dentition impression to the laboratory as well. These data may include photographs, scanning data files, and the like. In some embodiments, the HCP transmits the two sets of the data (selections and impression) simultaneously. In other embodiments, the HCP transmits one set of data prior to the other set of data, for example, by transmitting each set of data shortly after it is obtained.

[0062] In some embodiments, the data is communicated electronically. In some of these embodiments, the HCP transmits the data files by electronic mail. In other embodiments, the HCP transmits the data files by uploading and transmitting the files through a website. In some embodiments the data is incorporated into a 3D PDF, such as that provided by Adobe® (https://helpx.adobe.com/acrobat/using/displaying-3d-models- pdfs.htmli,

[0063] In some embodiments, a first HCP obtains the impression data and a second, different, HCP prepares the selections. In some embodiments, the first and the second HCP are coworkers while in other embodiments, they are not coworkers. In some embodiments, the same HCP who obtains the impression data is the same individual as the HCP who prepares the selections.

[0064] As mentioned above, from the dentition impression data a design of the patient's dentition is obtained, for example using CAD, by methods well-known in the art. In other embodiments, the HCP prepares the design and transmits it to the MFG. In other embodiments, the MFG obtains the raw data from the HCP and prepares the design in- house. [0065] In some embodiments, the HCP is in possession of all the patient data and design specifications used to treat the patient. The HCP can then draw conclusions and/or trends as to which design features are best suited for the treatment of which anomalies. In some embodiments, the data from all the HCPs is aggregated in one database to obtain a more accurate design-efficacy relationship for each patient anomaly. This process is sometimes referred to as "phenotyping," where a single or combination of design specifications is correlated with the treatment of a single malady. Whether aggregate data or single-HCP data us used, the result would be a more efficient treatment plan for future patients.

[0066] Subsequently, the computerized design of a dental device is prepared, taking into account the HCP's selections. The CAD file containing the design is then communicated to an automated manufacturing machine.

Manufacturing

[0067] The final stage of the process is the manufacture of the dental device. The CAD file containing the data related to the manufacture of the dental device is communicated with an automated manufacturing system.

[0068] In some embodiments, the appliance is manufactured additively, while in other embodiments, the appliance is manufactured subtractively. By "additive manufacturing" it is meant that the future device begins at a nucleus and grows from the nucleus. Examples of additive manufacturing include 3D printing (where the device grows out of a pool of monomers), injection molding (where the mold is filled with the monomer). By "subtractive manufacturing" it is meant that the future device is carved out of a block of material. Examples of subtractive manufacturing include hand carving and milling, e.g., an automated milling machine.

[0069] In some embodiments, depending on the type of selections made by the HCP, some clinical options, such as the Herbst lock or ball clasps, are incorporated into the device subsequent to the manufacturing step. In some embodiments, these clinical options are added automatedly by either the manufacturing device or another machine, while in other embodiments the clinical options are added manually. In some embodiments the device is the result of assembly of parts from both additive and subtractive manufacturing. The fully manufactured device is then provided to the patient either by the MFG or the HCP. [0070] In some instances, the HCP may be unsure of what titration mechanism works best for the patient, or that the patient may benefit from different types of titration mechanisms as the treatment progresses. For example, the HCP may require a Herbst mechanism for the initial stages of the treatment, but would like to switch to a microtitration or a strap mechanism when the patient's mandibular position approaches the desired location or for maintenance therapy. In these embodiments, the splints are designed and manufactured with an attachment mechanism, such as a ball-clasp system, friction lock, a nut for a screw-on attachment, and the like. One example of the attachment mechanism is disclosed in the USP 9,615,964, incorporated by reference herein in its entirety including the drawings. The splints and the attachments are then manufactured separately. The HCP can then swap out the attached mechanism for a different one as the needs of the patient change.

[0071] In another aspect, disclosed herein is a dental device that is manufactured by the methods disclosed above.

[0072] In another aspect, disclosed herein is a method of treating or ameliorating a jaw -related disorder in a patient by obtaining a dental device manufactured by the methods disclosed above and positioning the dental device over the dentition prior to sleep. The device then advances the mandible forward relative to the maxilla, thereby ameliorating the symptoms of sleep apnea or the jaw-related disorder. In some embodiments, the method further comprises instructing the patient in the use of the device. In some embodiments, the jaw-related disorder is selected from temporomandibular disorder (TBD), poorly positioned temporomandibular joint (TMJ), or aesthetic deficiencies.