Patent ID: 12186232

DETAILED DESCRIPTION OF THE EMBODIMENTS

In one aspect provided herein is a digitally designed and milled mandibular advancement device comprising an upper splint and a lower splint, wherein the upper and lower splints independently further comprise one or more fins. In some embodiments, the splints provide accurate increments of advancement of the lower jaw for titration of the mandible. The terms “dental splint” and “splint” as used herein refers to several types of orthodontic devices that are designed to address dental problems such as loose teeth and bruxism, in addition to problems with snoring and apnea.

A patient in need of the disclosed mandibular advancement devices wears the upper splint on the upper dentition and the lower splint on the lower dentition during sleep. The splints are designed to remain attached to the dentition until the patient removes them. The fins of the upper and lower splints cause a precise placement of the mandible in relation to the maxilla. The mandible is caused to stay in a forward position and does not relax and fall back. The airway constriction during the sleep is thereby minimized.

In one embodiment the device creates an offset between the upper and lower splint by using upper and lower fins as boundary surfaces to restrict movement while the mouth is closed or reasonably opened.

In some embodiments, the devices disclosed herein were digitally designed and then milled as a single unit. In some of these embodiments, a computer aided design (CAD) process were used to design and manufacture the mandibular advancement devices disclosed herein. A plaster model of the patient's dental impression were first obtained using well-known techniques in the art. Then, scans of the plaster models were imported into the CAD software. In other embodiments, the 3D files of the patient's impression are imported from other sources, such as a direct scan of the patient dentition using an Intra Oral Scan (IOS) Device, e.g., the 3M TruDef™ scanner, or a direct scan of the impression from either an IOS or Cone Beam Computed Tomography (CBCT) device. In these embodiments, the files enable the design of the mandibular advancement splint in 3D space in a CAD software such as 3-Matic by Materialise™.

In other embodiments, the different components of the disclosed devices, for example the splint, the fins, the retention arms, etc., are milled or manufactured separately and then attached together after the manufacturing. This approach allows for the use of interchangeable parts.

In one embodiment the digitally designed and milled splints are reproduced accurately without manual polymer buildup. In some embodiments, accurate reproduction results in accurate replacement devices. In other embodiments, it results in reproducible titration settings. In some embodiments the splints are digitally designed and milled to provide access to pre-cured polymeric materials, and wherein the device has minimal residual monomers.

In one embodiment one or more identifying information, e.g., the patient's name, order number, and other relevant tracking information, are designed into the device. The identifying information appears on the device through the milling process.

In one embodiment, the device is designed to comfortably fit on to a patient's upper and lower arches, maintain a maximum amount of space for the tongue, and keep the mandible advanced forward per a doctor's prescription while still allowing the patient to reasonably open their mouth and move their jaw from left to right for comfort. This contact serves as a barrier to keep the lower fin in a position forward of this fin engagement surface.

The disclosed devices can be made from any material that can withstand the oral environment for an extended period of time, for example overnight. Furthermore, the material can be any material that is capable of being milled to form the devices disclosed herein. Examples of materials include plastics and other polymers, whether hard or soft, transparent or opaque. Some suitable polymers include, but are not limited to, a polyetheretherketone (PEEK), polystyrene, polyvinyl chloride, rubber, synthetic rubber, or an acrylate polymer, such as a polymer made up of methyl methacrylate, methyl acrylate, ethyl acrylate, 2-chloroethyl vinyl ether, 2-ethylhexyl acrylate, hydroxyethyl methacrylate, butyl acrylate, butyl methacrylate, or trimethylolpropane triacrylate (TMPTA).

Embodiments of the device are further described with reference to the accompanying drawings.

FIG.1illustrates an embodiment of the disclosed mandibular advancement device,100.FIG.1ashows a front view of the device as it is worn in the mouth, whereasFIG.1bshows a side view of the same embodiment. The device100comprises and upper splint102and a lower splint104. The splint102is configured to fit snuggly onto the upper dentition106, while the lower splint104is configured to fit snuggly onto the lower dentition108. Each splint provides enough retention to keep the device on during normal wear but allowing the user to pull off the device with minimal effort. The two splints contact each other along the occlusal plane110, i.e., the plane passing through the biting surfaces of the teeth.

In one embodiment the thickness of the upper splint102and lower splint104is independently varied to create a fixed amount of jaw opening between the patient's arches.

The devices100disclosed herein are prepared individually and specially for a particular patient. For this reason, while preparing the digital design of the disclosed devices, the idiosyncrasies of the patient's oral and dentition structures are taken into account. For instance, in some embodiments, the opposing surfaces of the splint are designed in variance with each other to accommodate the patient's oral structure to achieve maximum comfort. The surfaces can be flat, or be made to touch at one or more points. This is true of any other feature of the devices100. For example, the height, width and shape of the fins; the rake angle; the offset position of the fins; the location of retention arms, if any; the dental impressions; inter alia, are designed specifically for the particular patient. This feature is easily enabled with a device that is digitally pre-designed. The currently available devices are handmade, making it difficult for the artisan to accurately take into account the specific oral features of a particular patient.

Each upper splint102comprises at least one upper fin114, and preferably two upper fins114. The fin114is located to the side of the upper splint102such that when the splint102is worn by the patient, the fin114is near the molars. Each upper fin114protrudes downwardly.

Similarly, each lower splint104comprises at least one lower fin116, and preferably two lower fins116. The fin116is located to the side of the lower splint104such that when the splint104is worn by the patient, the fin116is near the molars. Each lower fin116protrudes upwardly.

Throughout the present disclosure, the terms “up,” “upper,” or “upward,” and “down,” “lower,” or “downward” refer to the relative position of the upper jaw and the lower jaw. Thus, “protruding downwardly” means protruding away from the upper jaw and towards the lower jaw. Similarly, the words “front” or “forward” and “back” or “backward” refer to the relative position of components in the mouth. Thus, “front” means towards the lips, whereas “back” means towards the throat, when the device is in the mouth.

FIG.2Ashows the embodiment of the upper splint that is shown inFIG.1andFIG.2Bshows the embodiment of the lower splint that is shown inFIG.1.FIG.2depicts the splints by themselves and without being worn on the teeth.

The upper fin114comprises a front surface202and the lower fin116comprises a back surface204. When the device is worn in the mouth, the lower fin116is located in front of the upper fin114. The front surface202of the upper fin114contacts the back surface204of the lower fin116. This contact serves as a barrier to keep the lower fin in a position forward of this fin engagement surface. That is, the contact prevents the lower jaw from moving backward relative to the upper jaw. Thus, once the device is worn, the relative forward position of the upper and lower jaws becomes fixed. The patient would be able to open and close their mouth and move the lower jaw from left to right for comfort. However, the patient would not be able to move the lower jaw backwards beyond the point of contact of the two surfaces202,204.

In one embodiment the device is digitally designed and milled to provide optimal strength with reduced interference to the tongue creating a comfortable and durable device. As seen inFIGS.2A &2B, the two splints each form an arch with an empty center206. The empty center206provides room for the patient's tongue when the device is in use. The type of design that allows room for the tongue is referred to as lingual-less. Thus, some embodiments of the present device100are lingual-less designs.

The upper fin114is located at a distance UD (208) from the back of the upper splint102. Similarly, the lower fin116is located at a distance LD (210) from the back of the lower splint104. Distances208,210are also referred to as fin offset. The relative positioning of the fins determines the degree to which the lower jaw is protruded forward, i.e., the jaw offset. As discussed below, in some embodiments, the distances208and210are manipulated to provide the best fit for the patient.

In one embodiment, the upper and lower fins vary in angular shape at the contact surfaces of each fin to provide the most anatomically correct position and comfort during the motion of opening and closing the mouth. The embodiment shown inFIG.1comprises vertical contact surfaces. In these embodiments, the contact surfaces202and204are perpendicular to the occlusal plain110. In this embodiment, the rake angle, i.e., the angle that surface202makes with the occlusal plane110, is 90° to the occlusal plane, i.e., a neutral angle. In other embodiments, for example those shown inFIGS.3A and3B, the contact surfaces are at a non-neutral angle. For example, in the embodiment shown inFIG.3A, the rake angle is set in a recline orientation. In this embodiment, the surface202angles backward. Conversely, in the embodiment shown inFIG.3B, the rake angle is set in a procline orientation. In this embodiment, the surface202angles forward. The rake angle is configured to drive a directional movement during the opening and closing of the mouth. The particular angle, i.e., whether neutral, incline, or procline, and the angle degree, are chosen based on clinician prescription and patient comfort.

In one embodiment, the fins are selected from a predesigned digital library of fins.FIG.4shows additional embodiments of the fin design.FIGS.4A-4Dshow some of the embodiments used in a fin library. In some embodiments, a designer calls from a library of fin designs, for example those shown inFIGS.4A-4D, select one fin type (for example that shown inFIG.4C), and place onto the custom patient splint design, as shown inFIG.4E.

In some embodiments, for example that shown inFIG.5, there exists a gap502between the lower fin116and the lower splint104. While the fin116is attached to the splint104at the base, the fin116protrudes slightly outwards before protruding upward. In some embodiments, a corresponding gap exists between the upper fin114and the upper splint102. The gap502, if present, is designed into the device based on the prescription and patient anatomy and comfort. The gap502further allows for the side to side motion of the lower jaw with respect to the upper jaw.

When the device is worn by a patient and the patient's mouth is closed, the bottom surface of the upper splint and the top surface of the lower splint contact each other along the curve of the device, i.e., the arch of the mouth. The two surfaces contact each other along the plane of the splint. In one embodiment the opposing surfaces of the splint are designed such that the plane of the splint equals the occlusal plane. In some embodiments the plane of the splint is at an angle to the occlusal plane.FIG.6illustrates the ability to design devices in varying degrees of angle of the plane110of the splint to the occlusal plane602. In CAD, the angle of the plane110of the splint can be adjusted within the sagittal plane relative to the patient's anatomical occlusal plane602. Moreover the angle of the plane110can be adjusted within the frontal plane relative to the patient's occlusal plane602.

Both adjustments are useful to the clinician to affect changes to the relative positioning of the mandible and maxillae. The path of the movement of the upper and lower arches, for the opening and closing of the mouth, is affected by the engagement surface604, i.e., where the contact surfaces202and204meet. If the engagement surface604is not properly designed, then the upper and lower arches open and close along an unnatural arc, causing pain for the patient. In manufacturing the disclosed devices100, the natural arc of the patient's jaw movement is taken into account in the digital design. The engagement surface604is then designed to fit the natural arc.

In some embodiments, the device100is made of transparent materials, for example transparent plastic, to allow the clinician to see the patient's dentition through the device100to ensure good fit. Thus, in some embodiments, the clinician can insert a generic device100into the patient's mouth and mark the various measurements on the transparent device100instead of preparing a dental impression. In other embodiments, a transparent device100is prepared first, and relatively inexpensively, and the fit is tested before a more expensive and permanent device is manufactured.

In some embodiments the fins vary in length. In certain embodiments, the fins are adjusted to the patient's open mouth dimensions. In some embodiments, the fins vary in length related to the opposing fin to optimize the length required to maintain mandible offset position while considering comfort such that each fin is the same length or a fraction of the length of the opposing fin. The sum of the heights of an upper fin114and lower fin116is the total range of contact along the engagement surface before the two splints are separated. At the point of separation, the two splints do not exert pressure on each other and do not provide any jaw offset. In some embodiments, the upper fin114and lower fin116are of equal heights. In these embodiments, the total range is optimized while minimizing the height of either fin. The ratio of the heights of each fin can also be adjusted for patient comfort or clinical reasons.

In some embodiments, the thickness of each fin can be adjusted to apply more or less pressure against the cheek. The pressure on the cheek stimulates the body to adjust the muscles in the mouth area, e.g., the airway muscles, for patient comfort or clinical reasons.

In one embodiment the device embeds one or more structural features that create strength using less material. In some embodiments the structural feature is made from a single material. The term “embed” as used herein refers to a single material with design geometries or purposefully milled slots or other geometries that enable another material to be added as a support member, in the same way a rebar can strengthen a concrete block. In some embodiments the structural feature is made from a combination of materials, such a metal alloy. In some embodiments the metal or metal alloy is in the shape of a ball clasp, retention wire, or treatment wire. In some embodiments the treatment wires comprise of wires to aid in a clinical result deemed important by the practicing doctor, such as retention wires, alignment wires, or a tongue behavior modification wire such as spikes or barbs to affect tongue thrust.

A patient inserts the disclosed devices100into the patient's mouth before sleep and removes them after sleep. The devices should be retained in the mouth snugly enough so that the device does not fall out while the patient is sleeping. However, the fit cannot be too snug so that the patient cannot easily remove the device after waking up. The retention of the device100in the mouth is achieved using a combination of one or more of a variety of retention devices and gaps in space between the device and tissue.

In one embodiment the device is retained onto the teeth of a patient using patient specific retention arms. In some embodiments, the retention arms replace or improve the classic use of ball clasps. In the embodiments where ball clasps are used, space for their placement can easily be designed into the splint. In one embodiment,FIG.7shows the occlusal side of a splint with cutouts702designed into the device to accurately place ball clasps.

In some embodiments, for example that shown inFIG.8, the device100comprises retention arms802, built into either or both of the upper splint102and lower splint104. The retention arms802allow for a more secure placing of the splints into the mouth.FIG.8Ashows a free standing upper splint102with the retention arms802, whileFIG.8Bshows the graphics of how the upper splint102and the retention arms fit into the mouth of the patient. In some embodiments, the retention arms802take on the shape of the classic ball clasp, while in other embodiments, the retention arms802perfectly conform to the patient's anatomy to optimize strength and surface area for retention while allowing for maximum space for the tongue.

In some embodiments, a gap is designed between a particular device surface and one or more surfaces of a patient's anatomy. A purpose of the gaps is to allow the device100to be installed easily, stay retained under normal conditions, and be removed easily as well. In some embodiments, the gap is uniform across the entire contact region between the device and the patient's tissue. In other embodiments, the gap is strategically placed with properly designed spacing to provide easy installation of the device in the mouth, optimal device retention onto the patient's dentition, or ease of use of the device. The gap is easily programed into the CAD digital design. Because the disclosed device can be prepared quickly and inexpensively, the clinician or the designer can experiment with a series of different gap placings until the best fit is obtained.

It is possible, through a series of steps, called titration, to choose the device having the most clinically relevant mandibular advancement setting for the patient. Thus, in another aspect, disclosed herein methods of selecting a mandibular advancement device for a patient, the method comprising:a) obtaining two or more upper splints of the mandibular advancement device, wherein each upper splint comprises one or more upper fins, wherein each upper fin is located at a distance UD from back of the upper splint, and wherein the distance UD of any of the two or more upper splints is different than the distance UD of any other of the two or more upper splints; andobtaining two or more lower splints of the mandibular advancement device, wherein each lower splint comprises one or more lower fins, wherein each lower fin is located at a distance LD from back of the lower splint, and wherein the distance LD of any of the two or more lower splints is different than the distance LD of any other of the two or more lower splints;b) choosing a combination of one upper splint and one lower splint for the patient;c) observing the clinical outcome of the chosen combination of one upper splint and one lower splint;d) choosing a different combination of one upper splint and one lower splint for the patient if the clinical outcome of step c) is unacceptable; ande) repeating steps b)-d) until an acceptable clinical outcome is obtained.

Once a digital scan of the patient's dentition is obtained, a number of upper and lower splints are milled 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. An advantage of the devices and methods disclosed herein is that by digitally designing the splints and automatedly manufacturing them, several splints can be prepared relatively quickly and inexpensively. Further, the digital design allows for a precise positioning of the fins. A more effective mandibular advancement can then be obtained than by using a hand-milled and hand-cranked device.

In some embodiments, the titration settings provide for a flexible positioning of the fins in the mouth in the mesial-distal direction. In some embodiments, the fit of the device100on a patient is titrated through the use of devices100with varying distances208and210(seeFIG.2). In certain embodiments, the device100is milled directly from a CAD file such that the accuracy of the data from the impression of the patient's anatomy, the fit of the device to that data, and the design of the device are precisely transferred to the milling machine. This enables very precise design adjustment in positioning each of the fins in the splint, i.e., the measurement of the distances208and210, and in their position relative to each other in a reproducible and manufacturable way.

For example, in one embodiment, three different upper splints102were manufactured having increasingly longer distances208, i.e., longer fin offset. Also, two different lower splints104were manufactured having two different distances210. Thus, pairing one lower splint104with one upper splint102provided one jaw offset, while pairing the same upper splint102with a different lower splint104provided another jaw offset, and so on.

An illustrative example is shown in Table 1. To compile this table, five different upper splints102were prepared having 0.0 mm, 1.0 mm, 2.0 mm, 3.0 mm, and 4.0 mm fin offset (distance208), respectively. Also, four different lower splints104were prepared having 0.0 mm, 0.5 mm, 1.0 mm, and 2.0 mm fin offset (distance210), respectively. The combination of the two different splints can provide a jaw offset ranging from 0.0 mm to 6.0 mm, as shown in Table 1, where U-1 to U-5 are the upper splint offsets (shown in parentheses) and L-A to L-D are the lower splint offsets (shown in parentheses).

TABLE 1U-1U-2U-3U-4U-5(0.0 mm)(1.0 mm)(2.0 mm)(3.0 mm)(4.0 mm)L-A0.0 mm1.0 mm2.0 mm3.0 mm4.0 mm(0.0 mm)L-B0.5 mm1.5 mm2.5 mm3.5 mm4.5 mm(0.5 mm)L-C1.0 mm2.0 mm3.0 mm4.0 mm5.0 mm(1.0 mm)L-D2.0 mm3.0 mm4.0 mm5.0 mm6.0 mm(2.0 mm)

Thus, twenty different mandibular advancements can be obtained with only nine different splints, four lower splints and five upper splints.

Depending on the clinician's prescription need, the clinician chooses any reasonable value for the offset of the upper fin relative to the lower fin, and as many offsets as the clinician desires. Since the digital manufacturing process accurately and precisely reproduces the splints, the combination of splints is repeatable, regardless of when the clinician orders several splints or splints with other offset distances.

Another advantage of the disclosed splint combination is enabling the creation of the same offset with different combinations of upper and lower splint positions. For example, as shown in Table 1, a 3.0 mm offset may be created using three different combinations of upper and lower fins (L-A/U-4, L-C/U-3, and L-D/U-2). Varying the combined position of the two fins allow better alignment of the fins within the mouth for reasons of patient comfort and clinical requirements.

FIG.9illustrates the titration. Three separate upper splints102are provided, one having an upper fin offset of 1 mm (114-A), one having an upper fin offset of 2 mm (114-B), and one having an upper fin offset of 3 mm (114-B) (FIG.9shows all three of these upper splints superimposed on each other for illustration purposes. In actuality, they are separate splints.) One lower splint104, having a lower fin offset of 0.5 mm (116) is also provided. Not shown is a lower splint104having a lower fin offset of 0 mm. The following combinations of splints provide the mandibular advancements of Table 2.

TABLE 2UpperLower ▾1.0 mm2.0 mm3.0 mm0.0 mm1.0 mm2.0 mm3.0 mm0.5 mm1.5 mm2.5 mm3.5 mm

In another aspect, disclosed herein are methods of reducing partial constriction of airway during sleep for a patient, the method comprising identifying a patient in need thereof; and administering to the patient the mandibular advancement device as disclosed herein.

In another aspect, disclosed herein are methods of manufacturing a mandibular advancement device, the method comprising obtaining measurements from a patient's dentition; digitally designing a mandibular advancement device; and milling the mandibular advancement device. In some embodiments, the obtaining measurement step comprises obtaining a dental impression.