阅读说明：本技术 用于口内治疗的口腔件设备、相关系统及方法 (Mouthpiece apparatus, related systems, and methods for intraoral treatment ) 是由 C·斯库特斯库 于 2019-09-04 设计创作，主要内容包括：提供了用于口内治疗的可调节式口腔件设备。口腔件设备可以包括至少一个发射元件,用于发射至少一种治疗性发射物。在一些实施例中,口腔件设备包括上面板和下面板以及至少一个可调节连接器,该至少一个可调节连接器将上面板和下面板互连并且是可调节的,以改变上面板与下面板之间的间距。由此,可以针对一系列前庭高度调节口腔件设备。还提供了包括可调节式口腔件设备的相关系统以及用于制造可调节式口腔件设备的相关方法。(An adjustable mouthpiece apparatus for intra-oral treatment is provided. The mouthpiece device may include at least one emitting element for emitting at least one therapeutic emission. In some embodiments, the mouthpiece apparatus includes upper and lower panels and at least one adjustable connector interconnecting the upper and lower panels and being adjustable to change the spacing between the upper and lower panels. Thereby, the mouthpiece device may be adjusted for a range of vestibular heights. Related systems including the adjustable mouthpiece apparatus and related methods for manufacturing the adjustable mouthpiece apparatus are also provided.)

1. A mouthpiece apparatus for intra-oral treatment, comprising:

an upper panel to be positioned proximate to a user's upper teeth;

a lower panel to be positioned proximate to the user's mandibular teeth;

at least one adjustable connector interconnecting the upper panel and the lower panel and being adjustable to change a spacing between the upper panel and the lower panel; and is

Wherein at least one of the upper panel and the lower panel comprises at least one radiating element.

2. The mouthpiece device of claim 1, wherein the at least one adjustable connector is compressible and compression of the adjustable connector reduces a spacing between the upper and lower panels.

3. The mouthpiece apparatus of claim 1 or 2, wherein the upper and lower panels are substantially parallel.

4. The mouthpiece apparatus of claim 3, wherein each of the upper and lower panels includes a respective first end and a respective opposing second end, and wherein the at least one adjustable connector includes a first adjustable connector proximate the first ends of the upper and lower panels and a second adjustable connector proximate the second ends of the upper and lower panels.

5. The mouthpiece apparatus of claim 4, wherein each of the first and second adjustable connectors is substantially symmetrical.

6. The mouthpiece apparatus of any of claims 1-5, wherein the at least one adjustable connector is substantially S-shaped.

7. The mouthpiece apparatus of claim 6, wherein the at least one adjustable connector comprises: a substantially vertical upper section extending from the upper panel; a substantially vertical lower section extending from the lower panel, the lower section being horizontally offset relative to the upper section; and an intermediate section interconnecting the upper section and the lower section.

8. The mouthpiece apparatus of any of claims 4-7, wherein the at least one adjustable connector comprises a central adjustable connector approximately midway between the first and second ends of the upper and lower panels.

9. The mouthpiece apparatus of claim 8, further comprising a bite plate between the upper and lower panels.

10. The mouthpiece apparatus of claim 9, wherein the central adjustable connector includes an upper portion interconnecting the upper faceplate and the bite plate and a lower portion interconnecting the bite plate and the lower faceplate.

11. The mouthpiece apparatus of any of claims 1-10, wherein the at least one adjustable connector comprises a flexible resilient material.

12. The mouthpiece apparatus of any of claims 1-11, wherein the at least one adjustable connector comprises a plastically deformable material.

13. The mouthpiece apparatus of any of claims 1-12, wherein at least one of the upper panel and the lower panel comprises a first portion and a second portion, wherein the first portion and the second portion are interconnected by a flexible connection.

14. The mouthpiece device of any of claims 1 to 13, wherein the at least one emitting element is enclosed in a flexible housing.

15. The mouthpiece apparatus of claim 14, wherein the flexible housing includes at least one recess proximate to the at least one emitting element.

16. The mouthpiece apparatus of any of claims 1-15, wherein the at least one emitting element comprises at least one of an ultrasonic emitter, a light emitter, a heat emitter, a vibration emitter, or an electromagnetic field emitter.

17. The mouthpiece apparatus of any of claims 1 to 16, further comprising at least one flexible circuit board operatively connected to the at least one emitting element.

18. The mouthpiece apparatus of claim 17, wherein at least a portion of the at least one flexible circuit board is disposed within the at least one adjustable connector.

19. A system for intra-oral treatment, comprising:

the mouthpiece apparatus of any of claims 1 to 18;

an electronic controller operably connected to the at least one emissive element to control emissions from the at least one emissive element.

20. A method of manufacturing a mouthpiece apparatus for intra-oral treatment, the method comprising:

providing an upper panel and a lower panel; and

interconnecting the upper panel and the lower panel by at least one adjustable connector.

21. The method of claim 20, further comprising encapsulating each of the upper and lower panels in a respective flexible enclosure.

22. The method of claim 21, wherein interconnecting the upper panel and the lower panel comprises integrally forming the flexible housing and the at least one adjustable connector.

23. The method of claim 20, further comprising providing a bite plate core.

24. The method of claim 23, wherein interconnecting the upper panel and the lower panel comprises:

connecting the upper and lower face plates to the bite plate core to form a face plate/core assembly;

securing the panel/core assembly using a first portion of flexible elastomeric material; and

forming the at least one adjustable connector and encapsulating the fixed panel/core assembly in a flexible housing using a second portion of flexible resilient material.

The technical field is as follows:

the present disclosure relates to dental devices. More particularly, the present disclosure relates to mouthpiece apparatuses, related systems, and methods for intraoral treatment.

Background art:

intraoral treatment devices may be used to deliver therapeutic emissions (such as ultrasound, light, heat, etc.) to a patient's tooth root and to the bones and tissues supporting and surrounding the tooth root. Such an apparatus may include a mouthpiece that is received in the patient's mouth such that the at least one firing element is in close proximity to the root and/or the alveolar bone.

The oral anatomy may vary from person to person. The vestibule of the mouth, which may vary from person to person, is the area between the teeth, lips and cheeks. For example, a larger oral cavity may have a total vestibular height of about 55mm, while a smaller oral cavity may have a total vestibular height of about 35mm, or a very small oral cavity may even have a total vestibular height of 25 mm. Additionally, the width of the upper and lower arches, i.e. the crescent-shaped tooth arrangement in the maxilla and mandible, may also vary from person to person.

Conventional mouthpieces may only be one size and therefore only accommodate a single vestibular level, which may cause discomfort to patients having vestibular levels higher or lower than the height of the mouthpiece. Additionally, the oral components may not be optimally positioned to provide treatment to all of the user's tooth roots and other target tissues.

The invention content is as follows:

in one aspect, a mouthpiece apparatus is provided, the mouthpiece apparatus comprising: an upper panel to be positioned proximate to a user's upper teeth; a lower panel to be positioned proximate to the user's mandibular teeth; at least one adjustable connector interconnecting the upper panel and the lower panel and being adjustable to change a spacing between the upper panel and the lower panel; and wherein at least one of the upper panel and the lower panel comprises at least one radiating element.

In some embodiments, the at least one adjustable connector is compressible and compressing the adjustable connector reduces a spacing between the upper panel and the lower panel.

In some embodiments, the upper panel and the lower panel are substantially parallel.

In some embodiments, each of the upper and lower panels includes a respective first end and a respective opposing second end, and wherein the at least one adjustable connector includes a first adjustable connector proximate the first ends of the upper and lower panels and a second adjustable connector proximate the second ends of the upper and lower panels.

In some embodiments, each of the first and second adjustable connectors is substantially symmetrical.

In some embodiments, the at least one adjustable connector is substantially S-shaped.

In some embodiments, the at least one adjustable connector comprises: a substantially vertical upper section extending from the upper panel; a substantially vertical lower section extending from the lower panel, the lower section being horizontally offset relative to the upper section; and an intermediate section interconnecting the upper section and the lower section.

In some embodiments, the at least one adjustable connector comprises a central adjustable connector approximately midway between the first and second ends of the upper and lower panels.

In some embodiments, a bite plate is between the upper panel and the lower panel.

In some embodiments, the central adjustable connector comprises an upper portion interconnecting the upper panel and the bite plate and a lower portion interconnecting the bite plate and the lower panel.

In some embodiments, the at least one adjustable connector comprises a flexible resilient material.

In some embodiments, the at least one adjustable connector comprises a plastically deformable material.

In some embodiments, at least one of the upper panel and the lower panel comprises a first portion and a second portion, wherein the first portion and the second portion are interconnected by a flexible connection.

In some embodiments, the at least one radiating element is enclosed in a flexible housing.

In some embodiments, the flexible housing includes at least one recess proximate the at least one radiating element.

In some embodiments, the at least one transmitting element comprises at least one of an ultrasonic transmitter, a light transmitter, a heat transmitter, a vibration transmitter, or an electromagnetic field transmitter.

In some embodiments, the mouthpiece apparatus further comprises at least one flexible circuit board operatively connected to the at least one emitting element.

In some embodiments, at least a portion of the at least one flexible circuit board is disposed within the at least one adjustable connector.

In another aspect, a system for intraoral treatment is provided, comprising: embodiments of the mouthpiece apparatus described herein and an electronic controller operably connected to the at least one emitting element to control emissions from the at least one emitting element.

In another aspect, a method of manufacturing a mouthpiece apparatus for intra-oral treatment is provided, comprising: providing an upper panel and a lower panel; and interconnecting the upper panel and the lower panel by at least one adjustable connector.

In some embodiments, the method further comprises encapsulating each of the upper and lower panels in a respective flexible enclosure.

In some embodiments, interconnecting the upper panel and the lower panel includes integrally forming the flexible housing and the at least one adjustable connector.

In some embodiments, the method further comprises providing a bite plate core.

In some embodiments, interconnecting the upper panel and the lower panel comprises: connecting the upper and lower face plates to the bite plate core to form a face plate/core assembly; securing the panel/core assembly using a first portion of flexible elastomeric material; and forming the at least one adjustable connector and encapsulating the fixed panel/core assembly in a flexible housing using a second portion of flexible resilient material.

Other aspects and features of the present disclosure will become apparent to those ordinarily skilled in the art upon review of the following description of specific embodiments of the disclosure.

Description of the drawings:

fig. 1A is a front perspective view of a system for intraoral treatment including an adjustable mouthpiece apparatus, according to some embodiments;

FIG. 1B is a top perspective view of the system of FIG. 1A;

FIG. 2 is a side cross-sectional view of the system of FIGS. 1A and 1B, shown in the mouth of a user;

fig. 3 is a rear perspective view of the system of fig. 1A and 1B, showing the mouthpiece device in an expanded position;

fig. 4 is a side perspective view of the system of fig. 1A and 1B, showing the mouthpiece device in an expanded position;

fig. 5A is a rear perspective view of the system of fig. 1A and 1B, showing the mouthpiece apparatus in a compressed position;

fig. 5B is a side perspective view of the system of fig. 1A and 1B, showing the mouthpiece apparatus in a compressed position;

fig. 6A is a top perspective view of the system of fig. 1A and 1B, showing the top panel of the mouthpiece apparatus in a narrower configuration;

fig. 6B is a top perspective view of the system of fig. 1A and 1B, showing the top panel of the mouthpiece apparatus in a wide configuration;

FIG. 7 is a side perspective partial cross-sectional view of the mouthpiece apparatus of FIGS. 1A and 1B;

FIG. 8 is a side perspective partial cross-sectional view of the mouthpiece apparatus of FIGS. 1A and 1B;

FIG. 9 is a rear perspective partial cross-sectional view of the mouthpiece apparatus of FIGS. 1A and 1B;

fig. 10 is a top perspective partial cross-sectional view of the mouthpiece apparatus of fig. 1A and 1B;

FIG. 11 is a side perspective view of another system for intraoral treatment including an adjustable mouthpiece apparatus, showing the mouthpiece apparatus in an expanded position, according to some embodiments;

fig. 12 is a side perspective view of the system of fig. 11, showing the mouthpiece device in a compressed position;

FIG. 13 is a functional block diagram of another system for intraoral treatment including an adjustable mouthpiece apparatus, according to some embodiments;

fig. 14 is a flow chart of an exemplary method of manufacturing a mouthpiece apparatus for intra-oral treatment according to some embodiments; and

fig. 15 is a flow diagram of another exemplary method of manufacturing a mouthpiece apparatus for intra-oral treatment according to some embodiments.

The specific implementation mode is as follows:

in general, the present disclosure provides an adjustable mouthpiece apparatus for intra-oral treatment. The mouthpiece device may include at least one emitting element for emitting at least one therapeutic emission. In some embodiments, the mouthpiece apparatus includes upper and lower panels and at least one adjustable connector interconnecting the upper and lower panels and being adjustable to change the spacing between the upper and lower panels. Thereby, the mouthpiece device may be adjusted according to the range of vestibular heights. An associated system including an adjustable mouthpiece and an associated method for making an adjustable mouthpiece apparatus are also provided.

As used herein, the terms "top" and "bottom", "upper" and "lower", "upward" and "downward", "horizontal" and "vertical", and the like, refer to a typical orientation of a mouthpiece device for intraoral treatment when received in a user's mouth; however, those skilled in the art will recognize that these are relative terms, used only for ease of description, and do not limit the orientation of the mouthpiece device described herein.

An example of a system 100 for intra-oral treatment comprising an adjustable mouthpiece device 102 will be described with reference to fig. 1 to 10. Referring to fig. 1A and 1B, in this embodiment, the system 100 includes an adjustable mouthpiece apparatus 102 and an electronic controller 122. The mouthpiece device 102 may include an upper panel 104 to be positioned proximate to the user's upper teeth and a lower panel 110 to be positioned proximate to the user's lower teeth.

As described in more detail below, at least one of the upper panel 104 and the lower panel 110 may include at least one radiating element. The launching element may launch at least one therapeutic launcher toward a user's teeth, roots, alveolar bone, and/or any other associated tissue. The therapeutic emissions may include ultrasound, light, heat, vibration, electromagnetic fields, or any other suitable emissions. As used herein, "therapeutic projectile" refers to a projectile that provides at least one beneficial effect to a user. Non-limiting examples of benefits include: improving remodeling of the jaw and alveolar bone; improving healing after oral surgery or dental implantation; accelerating orthodontic tooth movement; accelerating the tooth root remodeling; repairing the tooth root for absorption; the repair of the fracture of the jaw bone and the alveolar bone caused by the removal of the wisdom teeth is accelerated; treating tooth sensitivity at the root or crown level; reduce gum infection; and improved healing of gingivitis and periodontitis, including healing after gingival flap surgery or alveolar bone graft surgery (two procedures used to treat periodontitis); and alleviating pain or inflammation associated with oral surgery.

The mouthpiece device 102 may further include at least one adjustable connector that interconnects the upper panel 104 and the lower panel 110 and is adjustable to change the spacing between the upper panel 104 and the lower panel 110. In this embodiment, the device 100 includes a first adjustable connector 116, an adjustable connector 118, and a third adjustable connector 120 between the first adjustable connector and the second adjustable connector.

In some embodiments, the mouthpiece device 102 may further include a bite plate 124 between the upper face plate 104 and the lower face plate 110. In this embodiment, the bite plate 124 is connected to the upper panel 104 and the lower panel 110 via the third adjustable connector 120. In other embodiments, the bite plate 124 can be connected to at least one of the upper panel 104 and the lower panel 110 by any other suitable means.

In some embodiments, the mouthpiece device 102 may further include a neck portion 126 between the upper and lower panels 104, 110 for connecting the mouthpiece device 102 to the electronic controller 122. In this embodiment, the neck portion 126 is integral with the bite plate 124, and the neck portion 126 extends from the bite plate 124 toward the electronic controller 122. In other embodiments, the neck portion 126 may be connected to at least one of the upper panel 104 and the lower panel 110 by any other suitable means.

The electronic controller 122 may be operably connected to the at least one emissive element of the upper panel 104 and the lower panel 110. In some embodiments, the electronic controller 122 includes a housing 123 that houses electronic components therein. The mouthpiece device 102 may engage the electronic controller housing 123. In some embodiments, the mouthpiece device 102 is permanently joined to the housing 123. In other embodiments, the mouthpiece device 102 is releasably engaged to the housing 123 such that the mouthpiece device 102 and the housing 123 may be disengaged from each other to allow replacement and/or repair of one or both of the mouthpiece device 102 and the electronic controller 122. In some embodiments, the neck portion 126 of the mouthpiece device 102 is at least partially received into a corresponding recess (not shown) in the housing 123.

Fig. 2 shows a system 100 in which a mouthpiece device 102 is received in a mouth 2 of a user. Mouthpiece device 102 is shown in cross-section through the middle of mouthpiece device 102.

The electronic controller 122 is shown in phantom in fig. 2 to illustrate where the electronic controller 122 should be located when in use by a user. The electronic controller 122 may be suitably sized such that the electronic controller 122 does not interfere with breathing through the nose 17 of the user. The electronic controller 122 may be positioned proximate the user's chin 16 to minimize the force generated by the weight of the electronic controller 122 on the user's mouth 2.

The upper panel 104 of the mouthpiece device 102 may be received in the maxillary vestibule 14 between the user's upper lip 10 and the user's upper gum 15 on the buccal side of the maxillary teeth 4 such that the upper panel 104 is adjacent to the maxillary root 6 of the maxillary teeth 4. The upper plate 104 can thus deliver therapeutic emissions to the maxillary root 6 of the maxillary tooth 4. The upper faceplate 104 may also deliver therapeutic emissions to the alveolar bone (not shown) around the maxillary root 6 and/or any other relevant adjacent tissue.

The lower panel 110 may be received in the mandibular vestibule 12 between the user's lower lip 11 and the user's lower gum 13 on the buccal side of the mandibular teeth 5 such that the lower panel 110 is adjacent the mandibular root 8 of the mandibular teeth 5. The lower plate 110 can thus deliver therapeutic emissions to the mandibular root 8 of the mandibular teeth 5. The lower plate 110 may also deliver therapeutic emissions to the alveolar bone (not shown) around the mandible root 8 and/or any other relevant adjacent tissue.

In some embodiments, coupling gels (not shown) may be employed between upper panel 104 and upper gum 15 and between lower panel 110 and lower gum 13 to facilitate delivery of the therapeutic emissions to the target area. For example, in embodiments where the therapeutic emissions are ultrasound, an ultrasound coupling gel may be used.

In some embodiments, the bite plate 124 may be bitten by the upper dental crown 7 of the user's upper teeth 4 and the lower dental crown 9 of the user's lower teeth 5 to help secure the mouthpiece device 102 in a desired position and prevent the mouthpiece device 102 from shifting in the user's oral cavity 2.

In some embodiments, the neck portion 126 of the mouthpiece device 102 may engage with the user's upper and lower lips 10, 11 to further secure the mouthpiece device 102 in a desired position. In some embodiments, the neck portion 126 may be relatively thin and flat to allow the patient's upper lip 10 and lower lip 11 to contact, thereby causing the user's mouth 2 to close almost completely around the neck portion 126. Closing the mouth 2 of the user may minimize saliva that may be stimulated by the presence of the mouthpiece device 102 and coupling gel (if used). In some embodiments, the user's upper and lower lips 10, 11 may also help secure the mouthpiece device 102 in a desired position by pushing the upper and lower panels 104, 110 inward, thereby maintaining contact between the upper panel 104 and the upper gum 15 and the lower panel 110 and the lower gum 13.

The mouthpiece device 102 may be adjustable for users with different vestibular heights. As shown in fig. 3 and 4, the mouthpiece device 102 may have an expanded position in which the upper and lower panels 104, 110 are separated by a maximum distance. The overall height H of the mouthpiece device 102 when the mouthpiece device 102 is in the expanded position₁Corresponding approximately to the maximum total vestibular height expected by the user. In some embodiments, the overall height H of the mouthpiece apparatus 102 when the mouthpiece is in the expanded position₁Is about 55 mm.

As shown in fig. 5A and 5B, a force may be applied to the mouthpiece device 102, as indicated by arrow a, to compress the upper and lower panels 104, 110 toward each other. In some embodiments, the force may be greater than the overall height H of the mouthpiece device 102 when the mouthpiece device 102 is received in the atrium height₁Short user times are applied in the mouth. As the user closes their lips 10, 11 around the neck portion 126 and bites into the bite plate 124, forces may be applied to the mouthpiece device 102 through the user's maxillary and mandibular vestibules 14, 12. In other embodiments, the force compressing the mouthpiece device 102 may be applied by the user's hand prior to insertion of the mouthpiece device into the user's mouth 2.

Thus, as shown in fig. 5A and 5B, the mouthpiece device 102 may also have at least one compressed position in which the upper and lower panels 104, 110 are compressed toward each other and the upper and lower panels 104, 110 are separated by less than a maximum separation. The overall height H of the mouthpiece device 102 when the mouthpiece device 102 is in the compressed position₂Can be less than the maximum total vestibular height expected by the user and the total height H₂May vary depending on the degree of compression of the upper and lower panels 104, 110 toward one another. In some embodiments, the height H when the mouthpiece device 102 is compressed₂May range from about 25mm up to about 55 mm.

In some embodiments, adjustable connectors 116, 118, and 120 are compressible. As used herein, "compressible" when used in reference to adjustable connectors 116, 118, and 120 refers to the ability of adjustable connectors 116, 118, and 120 to contract and/or flex to reduce the spacing between upper panel 104 and lower panel 110. The compression adjustable connectors 116, 118, and 120 may thereby allow the mouthpiece device 102 to be adjusted from the expanded position to the compressed position.

Thus, in some embodiments, the mouthpiece device 102 may be adjusted to allow various users having a variety of vestibular heights to use the mouthpiece device 102 while maintaining a suitable fit and user comfort. By adjusting the height of the mouthpiece device 102, the upper and lower face plates 104, 110 may be received as deep as possible in the user's maxillary and mandibular vestibules 14, 12 to deliver therapeutic shots to the maxillary and mandibular roots 6, 8, respectively, and the surrounding bone and tissue as desired.

The adjustable mouthpiece apparatus 102 will now be described in more detail with reference to figures 3 to 7.

As shown in fig. 3, the top panel 104 may have a first end 128 and an opposite second end 130. In this embodiment, the top panel 104 is generally rectangular in shape and curves from a first end 128 to a second end 130. In other embodiments, the upper panel 104 may be any other suitable shape to be received within the maxillary vestibule 14 of the user.

The top panel 104 may include a first portion 106 and a second portion 108. The first portion 106 and the second portion 108 may be interconnected at a flexible connection 136 that is approximately midway between the first end 128 and the second end 130 of the top panel 104. In this embodiment, the flexible connection 136 includes a generally V-shaped notch to provide clearance for a lace (not shown) of the user's upper lip 10. First portion 106 may extend from first end 128 to flexible connection 136 and second portion 108 may extend from flexible connection 136 to second end 130. In some embodiments, the first portion 106 and the second portion 108 may flex relative to each other about the flexible connection 136, as discussed in more detail below.

The lower panel 110 may have a first end 132 and an opposite second end 134. In this embodiment, the lower panel 110 is generally rectangular in shape and curves from the first end 132 to the second end 134. In other embodiments, the lower panel 110 may be any other suitable shape to be received within the mandibular vestibule 12 of the user.

The lower panel 110 may include a first portion 112 and a second portion 114. The first portion 112 and the second portion 114 may be interconnected at a flexible connection 138 that is approximately midway between the first end 132 and the second end 134 of the lower panel 110. In this embodiment, the flexible connection 138 includes a generally V-shaped notch to provide clearance for a strap (not shown) of the user's lower lip 11. First portion 112 may extend from first end 132 to flexible connection 138 and second portion 114 may extend from flexible connection 138 to second end 134. In some embodiments, the first portion 112 and the second portion 114 may flex relative to each other about the connection 138, as discussed in more detail below.

In some embodiments, the upper panel 104 and the lower panel 110 are substantially parallel. In some embodiments, the first end 128 of the upper panel 104 may be generally aligned with the first end 132 of the lower panel 110 and the second end 130 of the upper panel 104 may be generally aligned with the second end 134 of the lower panel 110. In some embodiments, the flexible connections 136 of the upper panel 104 may also be substantially aligned with the flexible connections 138 of the lower panel 110.

In some embodiments, each of the upper panel 104 and the lower panel 110 may be wider than the adjustable connectors 116, 118, and 120 and may extend further lingually than the adjustable connectors 116, 118, and 120. Accordingly, the upper panel 104 may thus define a first ridge 184 between the upper panel 104 and the adjustable connectors 116, 118, and 120, and the lower panel 110 may thus define a second ridge 186 between the lower panel 110 and the adjustable connectors 116, 118, and 120 (the ridges 184 and 186 are better illustrated in fig. 9). The depth of ridges 184 and 186 may be such that if the user has an orthodontic brace (not shown), such as a wire brace or a transparent appliance, the orthodontic brace cannot interfere with adjustable connectors 116, 118, and 120.

In some embodiments, the first adjustable connector 116 and the second adjustable connector 118 are laterally positioned to interconnect the upper panel 104 and the lower panel 110. The first adjustable connector 116 may interconnect the first portion 106 of the upper panel 104 and the first portion 112 of the lower panel 110. The second adjustable connector 118 may interconnect the second portion 108 of the upper panel 104 and the second portion 114 of the lower panel 110.

The third adjustable connector 120 may be centrally located to interconnect the upper panel 104 and the lower panel 110. The third adjustable connector 120 may be positioned approximately midway between the first ends 128 and 132 of the upper and lower panels 104 and 110, respectively, and the second ends 130 and 134 of the upper and lower panels 104 and 110, respectively.

In this embodiment, the first adjustable connector 116, the second adjustable connector 118, and the third adjustable connector 120 comprise, at least in part, a flexible elastomeric material. As used herein, "flexible, resilient material" means that the material can flex upon application of an external force and return to substantially its original shape after the force is removed. For the sake of clarity, the term "flexible elastic material" includes elastic materials that undergo elastic deformation. Non-limiting examples of suitable flexible elastic materials include elastomers and rubbers, such as: silicone elastomers and silicone rubbers.

When the mouthpiece device 102 is compressed, each of the first adjustable connector 116, the second adjustable connector 118, and the third adjustable connector 120 may exert a biasing force that urges the upper panel 104 apart from the lower panel 110. Thus, the biasing force may urge the upper and lower panels 104, 110 into the user's maxillary and mandibular vestibules 14, 12, respectively. In some embodiments, the first adjustable connector 116, the second adjustable connector 118, and the third adjustable connector 120 may be configured such that the biasing force applies only a slight pressure against the maxillary and mandibular vestibules 14, 12, thereby causing little discomfort to the user. In some embodiments, the flexible resilient material of the first adjustable connector 116, the second adjustable connector 118, and the third adjustable connector 120 may be configured such that the biasing force is substantially constant for the full compression range of the first adjustable connector 116, the second adjustable connector 118, and the third adjustable connector 120.

In this embodiment, the first adjustable connector 116 and the second adjustable connector 118 are substantially S-shaped. In some embodiments, the first adjustable connector 116 and the second adjustable connector 118 are substantially symmetrical.

The first adjustable connector 116 may have an upper end 141 and a lower end 143. The upper end 141 may be connected to the first portion 106 of the upper panel 104 and the lower end 143 may be connected to the first portion 112 of the lower panel 110. In this embodiment, the upper end 141 of the first adjustable connector 116 is proximate the first end 128 of the upper panel 104 and the lower end 143 is proximate the first end 132 of the lower panel 110.

In some embodiments, the first adjustable connector 116 includes a plurality of segments. In this embodiment, the first adjustable connector 116 includes an upper section 140, a middle section 142, and a lower section 144. The upper section 140 may be generally vertical and may extend downward from the upper panel 104. The lower section 144 may be generally vertical and may extend upward from the lower panel 110. The lower section 144 may be horizontally offset relative to the upper section 140. In some embodiments, the upper segment is generally aligned with the first end 128 of the upper panel 104, and the lower segment 144 may be spaced inwardly from the first end 132 of the lower panel 110 toward the flexible connection 136. In some embodiments, the upper and lower sections 140, 144 are substantially parallel to each other and substantially perpendicular to the upper and lower panels 104, 110.

The middle section 142 may be generally horizontal and may interconnect the upper section 140 and the lower section 144. In some embodiments, the middle section 142 may be substantially perpendicular to the upper and lower sections 140, 144 and substantially parallel to the upper and lower panels 104, 110.

In some embodiments, the upper and lower sections 140, 144 of the first adjustable connector 116 are relatively more rigid than the intermediate section 142. As shown in fig. 7, in this embodiment, the upper and lower sections 140, 144 comprise a thicker flexible, resilient material than the intermediate section 142, thereby increasing the rigidity of the upper and lower sections 140, 144 as compared to the intermediate section 142. In other embodiments, the upper and lower sections 140, 144 may each include a solid core (not shown) to increase the rigidity of the upper and lower sections 140, 144 as compared to the intermediate section 142.

Referring again to FIG. 3, the second adjustable connector 118 may have an upper end 147 and a lower end 149. The upper end 147 may be connected to the second portion 108 of the upper panel 104 and the lower end 149 may be connected to the second portion 114 of the lower panel 110. In this embodiment, the upper end 147 of the second adjustable connector 118 is proximate the second end 130 of the upper panel 104 and the lower end 149 is proximate the second end 134 of the lower panel 110.

In some embodiments, the second adjustable connector 118 includes a plurality of segments. In this embodiment, the second adjustable connector 118 includes an upper section 146, a middle section 148, and a lower section 150. The upper section 146, the intermediate section 148, and the lower section 150 may be similar in structure to the upper section 140, the intermediate section 142, and the lower section 144 of the first adjustable connector 116 described above. In some embodiments, the upper section 146, the middle section 148, and the lower section 150 of the second adjustable connector 118 are substantially symmetrical to the upper section 140, the middle section 142, and the lower section 144 of the first adjustable connector 116.

In some embodiments, the upper section 146 and the lower section 150 of the second adjustable connector 118 may be relatively more rigid than the middle section 148 in a manner similar to the first adjustable connector 116 described above.

As shown in fig. 5A and 5B, when a force is applied to the mouthpiece device 102, compressing the lower panels 110 of the upper panel 104 toward each other as indicated by arrow a, the middle section 142 of the first adjustable connector 116 and the middle section 148 of the second adjustable connector 118 may absorb a majority of the compressive force. Thus, the middle segments 142 and 148 may flex to allow the upper segments 140 and 146 of the first and second adjustable connectors 116 and 118 to shift toward the lower panel 110 and the lower segments 144 and 150 to shift toward the upper panel 104. In some embodiments, the first adjustable connector 116 and the second adjustable connector 118 remain substantially symmetrical when the mouthpiece device 102 is in the compressed position.

Referring again to FIG. 3, in this embodiment, the third adjustable connector 120 includes an upper portion 152 and a lower portion 154. The upper portion 152 may interconnect the upper panel 104 and the bite plate 124 and the lower portion 154 may interconnect the bite plate 124 and the lower panel 110. In other embodiments, the third adjustable connector 120 directly interconnects the upper panel 104 and the lower panel 110 without the bite plate 124 therebetween.

As shown in fig. 4, in this embodiment, the upper portion 152 of the third adjustable connector 120 extends from the upper faceplate 104 and connects to the bite plate 124 at an angle of less than 90 °. In this embodiment, the lower portion 154 of the third adjustable connector 120 extends from the lower faceplate 110 and connects to the bite plate 124 at an angle of less than 90 °. In some embodiments, the angle between the upper portion 152 and the bite plate 124 and the angle between the bite plate 124 and the lower portion 154 are close or approximately equal, thereby allowing the upper portion 152 and the lower portion 154 to be compressed in a similar manner.

In this embodiment, each of the upper portion 152 and the lower portion 154 comprises a relatively thin layer of flexible elastomeric material. In some embodiments, the flexible resilient material of the third adjustable connector 120 is the same as the flexible resilient material of the first and second adjustable connectors 116, 118. In other embodiments, the flexible resilient material of the third adjustable connector 120 may be different from the flexible resilient material of the first and second adjustable connectors 116, 118.

As shown in fig. 5B, when a force is applied to the mouthpiece 102 as indicated by arrow a, both the upper portion 152 and the lower portion 154 of the third adjustable connector 120 may flex to allow the upper and lower panels 104, 110 to move closer to each other.

Thus, in some embodiments, the first adjustable connector 116, the second adjustable connector 118, and the third adjustable connector 120 allow the mouthpiece device 102 to compress in a substantially symmetrical fashion such that the upper panel 104 remains substantially parallel to the lower panel 110. Thus, upper panel 104 and lower panel 110 may be suitably positioned to deliver therapeutic emissions over a wide range of atrium heights.

In other embodiments, the mouthpiece device 102 may include only the third adjustable connector 120 and not the first adjustable connector 116 and the second adjustable connector 118. In other embodiments, the mouthpiece device 102 may include one or both of the first adjustable connector 116 and the second adjustable connector 118 without the third adjustable connector 120. In other embodiments, the mouthpiece device 102 may include any other suitable adjustable connector or combination of adjustable connectors.

In some embodiments, at least one of the upper and lower panels 104, 110 of the mouthpiece device 102 may also be adjustable for a range of arch width users. Fig. 6A shows mouthpiece device 102 with upper panel 104 in a relatively narrow configuration, having an overall width W_1。Fig. 6B shows mouthpiece device 102 with upper panel 104 in a relatively wide configuration, having an overall width W₂Total width W₂Greater than the total width W₁. In the narrower and wider configurations, bite plate 124 can still be bitten by the user.

To adjust the top panel 104 to a narrower configuration, the first and second portions 106, 108 of the top panel 104 may be flexed toward one another. To adjust the top panel 104 to a wider configuration, the first and second portions 106, 108 may flex away from each other. In some embodiments, the first portion 106 and the second portion 108 of the top panel 104 may flex relative to each other about the flexible connection 136. The first and second portions 112, 114 of the lower panel 110 may similarly flex about the flexible connection 138 (not visible in fig. 6A and 6B). In some embodiments, flexible connections 136 and 138 may each comprise a flexible resilient material to allow upper panel 104 and lower panel 110 to flex about flexible connections 136 and 138. In some embodiments, the flexible resilient material of flexible connections 136 and 138 is the same as or similar to the flexible resilient material of adjustable connectors 116, 118, and 120.

In some embodiments, the flexible nature of adjustable connectors 116, 118, and 120 also allows upper panel 104 and lower panel 110 to flex about flexible connections 136 and 138 without being limited by the presence of adjustable connectors 116, 118, and 120.

The emitting elements of the mouthpiece device 102 will now be described in more detail with reference to fig. 8-10.

Referring to fig. 8, the upper panel 104 of the mouthpiece device 102 may include at least one first emitting element 168 and the lower panel 110 may include at least one second emitting element 170. In this embodiment, the first and second transmit elements 168, 170 comprise first and second ultrasonic transducers 169, 171, respectively.

In some embodiments, ultrasound transducers 169 and 171 each comprise a piezoelectric ultrasound transducer. In some embodiments, the piezoelectric transducer may be a bulk (thickness mode) piezoelectric transducer driven at or near resonance. The piezoelectric transducer may be circular, square, rectangular, or any other suitable shape. In some embodiments, the piezoelectric transducer may have an aspect ratio of approximately one. Examples of suitable piezoelectric transducers are the following: approximately circular, made of PZT (lead zirconate titanate), with a thickness of about 1.4mm (which represents half the wavelength of 1.5MHz of the resonant frequency in PZT material) and a diameter of about 28mm or less (which represents 10 wavelengths of 1.5MHz of the resonant frequency in PZT material). In some embodiments, the cushion of the transducer may comprise air or a low acoustic impedance material, such as foam. Additional details regarding suitable ultrasound transducers may be found, for example, in U.S. patent No. 9,232,986, which is incorporated herein by reference. In other embodiments, the first and second transmit elements 168, 170 may include any other suitable ultrasound transmit elements and embodiments are not limited to the ultrasound transducers described herein.

In other embodiments, first and second emitting elements 168, 170 may each comprise one of a light emitting element, a thermal emitting element, a vibrational emitting element, an electromagnetic emitting element, or any other type of emitting element that may be used to provide therapeutic emissions to a user. In some embodiments, the light emitting element and/or the heat emitting element may comprise a Light Emitting Diode (LED). In some embodiments, the vibration emitting element may comprise a small vibration motor. In some embodiments, the electromagnetic field emitting element may comprise a small antenna. In some embodiments, the first and second transmit elements 168, 170 are the same type of transmit element. In other embodiments, the first element 168 and the second element 170 may include different types of emitting elements.

In this embodiment, the upper panel 104 includes an upper array 164 of transmit elements 168 and the lower panel 110 includes a lower array 166 of transmit elements 170. In this embodiment, the upper array 164 and the lower array 166 are flexible arrays. As shown in fig. 10, the first portion 106 of the top panel 104 includes a first array portion 164a and the second portion 108 of the top panel 104 includes a second array portion 164 b. The first array portion 164a and the second array portion 164b may each include four first transmit elements 168, such that the upper array 164 includes a total of eight transmit elements 168. Similarly, the lower array 166 of the lower panel 110 may include a first array portion and a second array portion (not shown), and the first array portion and the second array portion each include four emissive elements 170. In other embodiments, the upper panel 104 and the lower panel 110 may each include any suitable number of radiating elements 168 and 170, respectively. Embodiments are not limited by the number or arrangement of the radiating elements described herein.

In this embodiment, all of the first transmit elements 168 in the upper array 164 include an ultrasonic transducer 169. In other embodiments, the first transmit elements 168 of the upper array 164 may include two or more different types of transmit elements. Similarly, in this embodiment, all of the transmit elements 170 of the lower array 166 include an ultrasound transducer 171. In other embodiments, the transmit elements 170 of the lower array 166 can include two or more different types of transmit elements.

In some embodiments, the mouthpiece device 102 includes at least one Flexible Circuit Board (FCB) operatively connected to the upper array 164 and the lower array 166. The FCB may also be operably connected to the electronic controller 122 to allow the upper array 164 and the lower array 166 to be controlled by the electronic controller 122. As shown in fig. 8, in this embodiment, an upper array 164 is operatively connected to the first FCB 156 and a lower array 166 is operatively connected to the second FCB 158.

At least a portion of the first FCB 156 and the second FCB 158 may be disposed within the third adjustable connector 120. In this embodiment, first FCB 156 extends from upper array 164 through first portion 152 of third adjustable connector 120 to bite plate 124. Within the bite plate 124, the first FCB 156 may be coupled to the bite plate core 160. The bite plate core 160 can comprise a relatively hard material, such as metal, hard plastic, or any other suitable material. The bite plate core 160 can extend from the neck portion 126 toward the electronic controller 122. Thus, the first FCB may extend from the neck portion 126 through the bite plate core 160 to connect to the electronic assembly 122. The first FCB 156 may be coupled to the bite plate 124 using a suitable adhesive or any other suitable coupling means.

The second FCB 158 may extend from the lower array 166, through the second portion 154 of the third adjustable connector 120, to the bite plate 124. Within the bite plate 124, a second FCB 158 may be coupled to the bite plate core 160, and the second FCB 158 may extend out of the neck portion 126 through the bite plate core 160 to connect to the electronics assembly 122. By operably connecting the upper array 164 and the lower array 166 to the electronic controller 122 via the flexible circuit boards 156 and 158, the first portion 152 and the second portion 154 of the third adjustable connector 120 may still flex without damaging the FCBs 156 and 158.

In some embodiments, at least a portion of the mouthpiece device 102 is enclosed within a flexible housing 176. In some embodiments, the flexible housing 176 comprises a flexible elastomeric material. In some embodiments, the flexible resilient material is the same as or similar to the flexible resilient material of adjustable connectors 116, 118, and 120. For example, the flexible resilient material may be an elastomeric material or a rubber material, such as a silicone elastomer or rubber.

As shown in fig. 8, in some embodiments, at least one of the emitting elements 168, 170 is enclosed in a flexible housing 176. In this embodiment, the upper array 164 of transmit elements 168 is enclosed in a first flexible housing portion 178 and the lower array 166 of transmit elements 170 is enclosed in a second flexible housing portion 180. In some embodiments, the thickness of the flexible housing portions 178 and 180 proximate the transmit elements 168 and 170 is approximately the same or similar to the thickness of the transmit elements 168 and 170 themselves; for example, approximately the thickness of the ultrasonic transducers 169 and 171. In other embodiments, the thickness of the flexible housing portions 178 and 180 may be any other suitable thickness to allow therapeutic emissions from the emitting elements 168 and 170 to pass through the flexible housing portions 178 and 180 to the target area of the user.

In some embodiments, the first flexible housing portion 178 may at least partially surround each of the first transmit elements 168 in the upper array 164 such that a portion of the flexible elastomeric material is disposed between each of the transmit elements 168. Thus, in embodiments where the upper array 164 is a flexible array, the combination of the flexible elastomeric material between the transmit elements 168 and the flexible nature of the upper array 164 may allow the upper panel 104 to flex between each of the first transmit elements 168. Similarly, in some embodiments, the second flexible housing portion 178 may at least partially surround each second emissive element in the lower array 168 such that a portion of the flexible elastomeric material is disposed between each emissive element 170, thereby allowing the lower panel 110 to flex between each second emissive element 170.

In some embodiments, at least one of the flexible housing portions 178, 180 defines at least one recess proximate at least one radiating element. As shown in fig. 9 and 10, the inner wall 177 of the first flexible housing portion 178 defines at least one first recess 172 proximate at least one first emitter element 168 of the upper array 164 (note that the first emitter element 168 and the upper array 164 are not shown in fig. 9). The inner wall 179 of the second flexible housing 180 can define at least one second recess 174 proximate to the at least one second radiating element 170 of the lower array 166 (note that the second radiating element 170 and the lower array 166 are not shown in fig. 9 and 10). In this embodiment, the inner wall 177 of the first housing portion 178 defines eight first recesses 172, each first recess 172 being proximate a respective first emitter element 168 in the upper array 164. The inner wall 179 of the second flexible housing 180 can also define eight second recesses 174, each second recess 174 being proximate to a respective second radiating element 170 in the lower array 166. When the mouthpiece device 102 is received in the user's mouth, the recesses 172 and 174 in the respective inner walls 177 and 179 of the first housing portion 178 and the second housing portion 180 may face the user's maxillary root 6 and mandibular root 8, respectively.

In some embodiments, each of first recess 172 and second recess 174 are relatively shallow concave recesses. In this embodiment, each recess 172 and 174 has a depth of about 200 μm. In other embodiments, each recess 172 and 174 may have any other suitable depth. In this embodiment, each of the first recess 172 and the second recess 174 is substantially circular. In other embodiments, each of first recess 172 and second recess 174 may be substantially oval, elliptical, or any other suitable shape. In some embodiments, each of the first recess 172 and the second recess 174 is substantially centered on the respective first emission unit 168 and the second emission unit 170.

In this embodiment, the recesses 172 and 174 function to increase the Effective Radiating Area (ERA) and reduce the beam non-uniformity (BNR) of the ultrasound transducers 169 and 171. In embodiments where the emitting elements 168 and 170 are light emitting elements, the recesses 172 and 174 may function to collimate the light emitted by the light emitting elements. In other embodiments, the indentations may provide any other effective effect on the therapeutic emissions emitted by emitting elements 168 and 170, including but not limited to the amount or intensity of therapeutic emissions delivered to the target tissue of the user. Thus, in some embodiments, the recesses 172 and 174 may improve delivery of therapeutic emissions to the user's maxillary and mandibular roots 6 and 8, as well as any other targeted bone and/or tissue.

In some embodiments, other components of the mouthpiece device 102 may also be enclosed in a flexible housing. In this embodiment, as shown in fig. 8, the bite plate 124 and neck portion 126 are enclosed in a third flexible housing portion 182. The third flexible housing portion 182 may include a flexible elastomeric material as described above for the first and second flexible housings 178, 180. In some embodiments, the third flexible housing portion 182 includes an annular ridge 162 to form a seal around the electronics housing assembly 123 (not shown in fig. 8) when the end section 127 of the neck portion is received into a corresponding recess (not shown) of the housing 123.

In some embodiments, the first, second, and third flexible housing portions 178, 180, 182 and the first, second, and third adjustable connectors 116, 118, 120 are all made of the same flexible elastomeric material. In some embodiments, the flexible housing portions 178, 180, and 182 and the adjustable connectors 116, 118, and 120 are integrally formed. In other embodiments, one or more of the flexible housing portions 178, 180, and 182 and the adjustable connectors 116, 118, and 120 may be made of different materials. In some embodiments, the flexible housing portions 178, 180, and 182 and one or more of the adjustable connectors 116, 118, and 120 may be coupled to each other by any suitable means.

A second example of a system 200 for intra-oral treatment, comprising an adjustable mouthpiece device 202, will now be described with reference to fig. 11 and 12. As shown in FIG. 11, in this embodiment, system 200 includes an adjustable mouthpiece apparatus 202 and an electronic controller 222.

The mouthpiece device 202 may include an upper face plate 204 and a lower face plate 210. At least one of the upper panel 204 and the lower panel 210 may include at least one radiating element (not shown). The emitting elements may be similar to the emitting elements 168 and 170 of the mouthpiece device 102 described above. In this embodiment, the top panel 204 includes a first portion 206 and a second portion 208. The lower panel 210 may include a first portion 212 and a second portion 214.

The mouthpiece apparatus 202 may further include a bite plate 224 and a neck portion 226. In this embodiment, the neck portion 226 has an end section 227 to be received in a corresponding recess (not shown) in the housing 223 of the electronic controller 222. The electronic controller 222 may be operably connected to the emissive element of the mouthpiece apparatus 202.

In this embodiment, the mouthpiece apparatus 202 includes a first adjustable connector 216, a second adjustable connector 218, and a third adjustable connector 220 between the first adjustable connector and the second adjustable connector. The first adjustable connector 216, the second adjustable connector 218, and the third adjustable connector 220 may be compressible, and compressing the first adjustable connector 216, the second adjustable connector 218, and the third adjustable connector 220 may allow the upper panel 204 and the lower panel 210 to move toward each other and thereby reduce the spacing between the upper panel 204 and the lower panel 210.

The first adjustable connector 216 may interconnect the first portion 206 of the top panel 204 and the first portion 212 of the bottom panel 210. The second adjustable connector 218 may interconnect the second portion 208 of the upper panel 204 and the second portion 214 of the lower panel 210. In some embodiments, the first adjustable connector 216 and the second adjustable connector 218 are substantially symmetrical.

The third adjustable connector 220 may be positioned substantially centrally in the middle between the first adjustable connector 216 and the second adjustable connector 218. The third adjustable connector may include an upper portion 252 and a lower portion 254. The upper portion 252 can connect the upper panel 204 with the bite plate 224 and the lower portion 254 can connect the bite plate 224 with the lower panel 210.

In this embodiment, first adjustable connector 216, second adjustable connector 218, and third adjustable connector 220 comprise, at least in part, a plastically deformable material. As used herein, "plastic deformation" refers to the following materials: may be deformed into different shapes or positions upon application of an external force and retain its deformed shape or position after removal of the force. In this embodiment, the plastically deformable material comprises one or more wires. In some embodiments, the wires are formed as a mesh. In other embodiments, the plastically deformable material may comprise any other suitable material, and the embodiments are not limited to the materials described herein.

In some embodiments, the one or more wires are incorporated into a flexible, resilient material. As used herein, "bonding" may refer to encapsulating or embedding the wire in a flexible, resilient material or combining the wire and flexible, resilient material by any suitable means. The flexible elastic material may for example be an elastomer or rubber, such as a silicone elastomer or rubber. In other embodiments, the flexible resilient material may be any other suitable material. In some embodiments, the same or similar flexible resilient material may be used to encapsulate at least a portion of the mouthpiece device 202 in a flexible housing in a manner as described above with respect to the mouthpiece device 102.

The mouthpiece device 202 may be adjusted via a first adjustable connector 216, a second adjustable connector 218, and a third adjustable connector 220. As shown in fig. 11, the mouthpiece device 202 may have an expanded position in which the upper face plate 204 is separated from the lower face plate 210 by a maximum distance. Total height H 'of mouthpiece apparatus 202 when mouthpiece apparatus 202 is in the expanded position'₁Corresponding approximately to the maximum total vestibular height expected by the user.

As shown in fig. 12, the mouthpiece device 202 may also have at least one compressed position in which the upper and lower panels 204, 210 are compressed toward each other and the upper and lower panels 204, 210 are separated by less than the maximum separation. Total height H 'of mouthpiece when mouthpiece apparatus 202 is in the compressed position'₂May vary depending on the degree to which the upper panel 204 and lower panel 210 are compressed toward one another.

When a force is applied to the mouthpiece device 202 to compress the upper and lower panels 204, 210 toward each other as indicated by arrow B, each of the first adjustable connector 216, the second adjustable connector 218, and the third adjustable connector 220 may deform to allow the upper and lower panels 204, 210 to move toward each other. First adjustable connector 216, second adjustable connector 218, and third adjustable connector 220 may maintain their deformed state after the force is removed. In some embodiments, the first adjustable connector 216, the second adjustable connector 218, and the third adjustable connector 220 may be manually readjusted to their original states, if desired.

Fig. 13 is a functional block diagram of a system 300 for intraoral treatment according to some embodiments. In this embodiment, the system 300 includes an adjustable mouthpiece apparatus 302 and an electronic controller 322. The mouthpiece apparatus 302 and the electronic controller 322 may be similar in structure to the mouthpiece apparatus 102 or 202 and the electronic controller 122 or 222 described above with reference to fig. 1-12.

In this embodiment, the mouthpiece 302 includes an upper array 304 of radiating elements 305 and a lower array 310 of radiating elements 307. In some embodiments, the transmit elements 305 and 307 are ultrasonic transducers as described above. In other embodiments, the radiating elements 305 and 307 are any other suitable type of radiating element.

In this embodiment, the electronic controller 322 includes a drive circuit 312, a processor 314, a power supply 316, a user interface 318, a transceiver 324, and a memory 326.

The upper array 304 may be operatively connected to a driver circuit 312 via a first flexible circuit board 306, and the lower array 310 may be operatively connected to the driver circuit 312 via a second flexible circuit board 308. The drive circuit 312 may drive the transmit elements 305, 307 of the upper array 304 and the lower array 310. In some embodiments, the drive circuit 312 includes multiple drivers such that the upper array 304 and the lower array 310 can be driven independently, and in some embodiments, each of the emissive elements 305, 307 can be driven independently.

The driver circuit 312 may be operatively connected to a power supply 316 and a processor 314. In some embodiments, the power supply 316 includes a battery. In some embodiments, the power supply 316 also includes an inductive charging coil (not shown) and battery charging circuitry (not shown) to allow the battery to be inductively charged. In other embodiments, power supply 316 may include any other suitable power supply. In some embodiments, the electronic controller 322 may also include at least one voltage regulator (not shown) to regulate the voltage from the power supply 316.

The processor 314 may process user input from the user interface 318 and activate the drive circuit 312 in response to the user input. In some embodiments, the user interface 318 includes controls, such as buttons. In some embodiments, the user interface 318 further includes at least one light source (not shown), such as one or more LEDs, to indicate one or more states of the system 300. For example, an LED may emit light of one color when the system 300 is active and another color when the system 300 encounters an error.

The memory 326 is operatively connected to the processor 314. Memory 326 may store processor-executable instructions to be executed by processor 314. For example, memory 326 may store instructions for a particular treatment protocol to be implemented by system 300, including pulse duration, intensity, etc. settings for transmit elements 305 and 307.

The transceiver 324 is also operatively connected to the processor 314. The transceiver 324 may be configured to send and receive communications over a communication network such as intel. In some embodiments, the transceiver 324 comprises a bluetooth transceiver. In some embodiments, the transceiver 324 includes both a transmitter and a receiver that share common circuitry. In other embodiments, the transceiver 324 includes separate transmitters and receivers.

In some embodiments, the electronic controller 322 may thereby transmit information regarding the use and operation of the system 300 to the user and/or the user's medical provider via the communication network. For example, the electronic controller 322 may transmit information regarding how often the user activates the arrays 304, 310 of mouthpiece devices 302 by pressing a button. The electronic controller 322 may also receive information from the user or the user's medical provider via a communication network. For example, the user's healthcare provider may transmit instructions for a new treatment plan.

In some embodiments, system 300 includes any other suitable components, such as an RF (radio frequency) signal generator, an EMC (electromagnetic compatibility) filter, and/or any other suitable component.

A method of making an adjustable mouthpiece apparatus for intra-oral treatment is also provided. This method may be used to manufacture embodiments of the mouthpiece apparatus 102, 202 described herein.

Fig. 14 is a flow diagram of an example method 400 for manufacturing a mouthpiece apparatus, according to some embodiments. At block 402, an upper panel and a lower panel are provided. In some embodiments, at least one of the upper and lower panels may include at least one radiating element. The upper and lower panels may be similar in construction to the upper and lower panels 104, 204, 110, 210 described above. As used herein, "providing" the upper and lower panels refers to manufacturing, producing, receiving, or otherwise obtaining the upper and lower panels.

In some embodiments, providing the upper and lower panels includes providing an upper array of transmit elements and a lower array of transmit elements. The upper and lower arrays may be similar in structure to the upper and lower arrays 164, 166 described above. In some embodiments, the transmitting element comprises at least one of an ultrasound transmitter, a light transmitter, a heat transmitter, a vibration transmitter, and an electromagnetic field transmitter.

At block 404, the upper and lower panels may be interconnected by at least one adjustable connector. The structure of the adjustable connectors may be similar to the adjustable connectors 116, 118, and 120 of the mouthpiece device 102 or the adjustable connectors 216, 218, 220 of the mouthpiece device 202. In some embodiments, the adjustable connector comprises, at least in part, a flexible elastomeric material. In some embodiments, the adjustable connector comprises, at least in part, a plastically deformable material.

In some embodiments, the method 400 further comprises encapsulating each of the upper and lower panels in a respective flexible enclosure. In some embodiments, interconnecting the upper and lower panels with the at least one adjustable connector includes integrally forming the flexible housing and the adjustable connector. In some embodiments, the flexible housing and the adjustable connector are formed from a flexible elastomeric material.

In other embodiments, interconnecting the upper and lower panels may include coupling the upper panel to a first end of the adjustable connector and coupling the lower panel to a second end of the adjustable connector using any suitable coupling means.

Fig. 15 is a flow diagram of another exemplary method 500 for manufacturing an adjustable mouthpiece apparatus according to some embodiments. At block 502, an upper panel and a lower panel are provided. Block 502 may have similar steps as block 402 of method 400 described above.

At block 504, a bite plate core is provided. The bite plate core structure may be similar to the bite plate core 160 of the mouthpiece apparatus 102 as described above.

At block 506, the upper and lower face plates are connected to a bite plate core to form a face plate/core assembly. In some embodiments, the upper panel is connected to the bite plate core by a first Flexible Circuit Board (FCB). The first FCB may be similar in structure to the first FCB 156 of the mouthpiece device 102 described above. The lower facing plate may be connected to an opposite side of the bite plate core by a second FCB. The second FCB may be similar in structure to the second FCB 158 of the mouthpiece 102 described above. The first and second FCBs may be coupled to the bite plate core using a suitable adhesive or any other suitable coupling means.

At block 508, the panel/core assembly is secured using the first portion of the flexible, resilient material. In some embodiments, as described in more detail below with respect to block 510, the fixed panel/core assembly comprises: the panel/core assembly is placed in a first mold and a first portion of a flexible elastomeric material is injected into the first mold to form at least one strip of flexible elastomeric material on and/or around at least a portion of the panel/core assembly to secure the components of the panel/core assembly together and to provide a desired location for the second mold panel/core assembly. In some embodiments, a first strip of flexible elastomeric material may extend from the upper array along the first FCB to the bite plate core, thereby securing the upper faceplate, the first FCB, and the bite plate core together. A second strip of flexible elastomeric material may extend from the lower array along the second FCB to the bite plate core, thereby securing the lower face plate, the second FCB, and the bite plate core together. In embodiments where the upper and lower panels include respective arrays of radiating elements, a plurality of strips of flexible resilient material may be formed between and/or around the radiating elements to secure the radiating elements in the arrays.

At block 510, at least one adjustable connector may be formed and the panel/core assembly may be encapsulated in a flexible shell using a second portion of flexible elastomeric material. In some embodiments, the fixed panel/core assembly may be placed in a second mold, and a second portion of flexible elastomeric material may be injected into the second mold to form the adjustable connector and encapsulate the fixed panel/core assembly in the flexible housing. In some embodiments, the flexible enclosure comprises: a first housing section enclosing the upper panel; a second housing portion enclosing a lower panel; and a third housing portion encapsulating the bite plate core. Thus, in this embodiment, the adjustable connector and the flexible housing may be substantially integral with one another.

Various modifications in addition to those already described are possible without departing from the concepts disclosed herein. Moreover, in interpreting the disclosure, all terms should be interpreted in the broadest possible manner consistent with the context. In particular, the terms "comprises" and "comprising" should be interpreted as referring to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps that are not expressly referenced.

While particular embodiments have been shown and described, it will be understood by those skilled in the art that various changes and modifications may be made without departing from the scope of the disclosure. The terms and expressions which have been employed in the foregoing specification are used therein as terms of description and not of limitation, and there is no intention in the use of such terms and expressions of excluding equivalents of the features shown and described or portions thereof.