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WO2025035013A1 - Dispositifs intrabuccaux - Google Patents

Dispositifs intrabuccaux Download PDF

Info

Publication number
WO2025035013A1
WO2025035013A1 PCT/US2024/041542 US2024041542W WO2025035013A1 WO 2025035013 A1 WO2025035013 A1 WO 2025035013A1 US 2024041542 W US2024041542 W US 2024041542W WO 2025035013 A1 WO2025035013 A1 WO 2025035013A1
Authority
WO
WIPO (PCT)
Prior art keywords
wall
light
light strip
light source
strip
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2024/041542
Other languages
English (en)
Inventor
Toru Saito
Leoncio Angel Gonzalez
David Mandel
Paul GANCITANO
Christopher Terella
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sunstar Americas Inc
Original Assignee
Sunstar Americas Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Sunstar Americas Inc filed Critical Sunstar Americas Inc
Publication of WO2025035013A1 publication Critical patent/WO2025035013A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C19/00—Dental auxiliary appliances
    • A61C19/06—Implements for therapeutic treatment
    • A61C19/063—Medicament applicators for teeth or gums, e.g. treatment with fluorides
    • A61C19/066—Bleaching devices; Whitening agent applicators for teeth, e.g. trays or strips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N5/0601—Apparatus for use inside the body
    • A61N5/0603—Apparatus for use inside the body for treatment of body cavities
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/30—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N5/0601—Apparatus for use inside the body
    • A61N5/0603—Apparatus for use inside the body for treatment of body cavities
    • A61N2005/0606—Mouth
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N2005/065—Light sources therefor
    • A61N2005/0651—Diodes
    • A61N2005/0652—Arrays of diodes

Definitions

  • the present disclosure relates to intraoral devices, methods of manufacture, and methods of use.
  • the disclosure relates to intraoral devices including a plurality of light sources configured to kill bacteria.
  • Intraoral devices may be used to clean and whiten teeth (e.g., by killing oral bacteria).
  • an intraoral device may be formed from a frame, a plurality of light sources, and molding over the light sources and the frame.
  • a user may insert the intraoral device in their mouth.
  • a user may also trigger the intraoral device to emit light within the user’s mouth.
  • an intraoral device in one aspect, includes a body including an inner wall, an outer wall, and a bite surface extending between the inner wall and the outer wall.
  • the inner wall, outer wall, and the bite surface define an upper channel and a lower channel.
  • the inner wall further comprises an inner wall upper portion and an inner wall lower portion.
  • the outer wall further comprises an outer wall upper portion and an outer wall lower portion.
  • the intraoral device also includes a first light strip arranged on the inner wall upper portion, a second light strip arranged on the inner wall lower portion, a third light strip arranged on the inner wall lower portion, and a fourth light strip arranged on the outer wall lower portion.
  • Each of the first light strip, the second light strip, the third light strip, and the fourth light strip comprising light sources, and each light source is configured to emit light having a wavelength of 441 nm to 459 nm at an intensity of 98 mW/cm 2 to 102 mW/cm 2 . Additionally, each light source has a height no greater than 0.8mm and a viewing angle of at least 125 degrees.
  • the example intraoral device also includes a battery supported on the body configured to power the light sources and an initiation switch configured to control the flow of electricity from the battery to the light sources.
  • a method of manufacturing an intraoral device may comprise, providing a frame, the frame defining an inner wall, an outer wall, and a first bite surface portion extending between a portion of the inner wall and a portion of the outer wall.
  • the inner wall, outer wall, and the bite surface define an upper channel and a lower channel.
  • the inner wall comprises an inner wall upper portion and an inner wall lower portion.
  • the outer wall comprises an outer wall upper portion and an outer wall lower portion.
  • the method further comprises, coupling a first light strip to the inner wall upper portion, coupling a second light strip to the outer wall upper portion, coupling a third light strip to the inner wall lower portion, coupling a fourth light strip to the outer wall lower portion.
  • Each of the first light strip, the second light strip, the third light strip, and the fourth light strip comprising light sources, and each light source is configured to emit light having a wavelength of 441 nm to 459 nm at an intensity of 98 mW/cm 2 to 102 mW/cm 2 .
  • the method further comprises forming a body by molding over the frame, the first light strip, the second light strip, the third light strip, and the fourth light strip.
  • the body further defines a second bite surface portion.
  • the method further comprises coupling a battery to the body, the battery being electrically coupled to the light sources and initiator switch.
  • an intraoral device may include: a body, including: an inner wall including an inner wall upper portion and an inner wall lower portion, an outer wall including an outer wall upper portion and an outer wall lower portion, a bite surface at least partially extending between the inner wall and the outer wall, the inner wall upper portion defining distal ends and a middle portion, the middle portion having an angle relative to the bite surface different from an angle of the distal ends relative to the bite surface; and the inner wall lower portion defining distal ends and a middle portion, the middle portion having an angle relative to the bite surface different from an angle of the distal ends relative to the bite surface; wherein the angle of the middle portion of the inner wall lower portion is different from the angle of the middle portion of the inner wall upper portion; wherein the inner wall, the outer wall, and the bite surface define an upper channel and a lower channel, a first light strip arranged on the inner wall upper portion, a second light strip arranged on the outer wall upper portion, a third light strip arranged on
  • a method of operating an intraoral device comprising, providing a body, the body including an inner wall comprising an inner wall upper portion and an inner wall lower portion, an outer wall comprising an outer wall upper portion and an outer wall lower portion, a bite surface at least partially extending between the inner wall and the outer wall.
  • the inner wall, the outer wall, and the bite surface define an upper and lower channel.
  • the body further includes a first light strip arranged on the inner wall upper portion, a second light strip arranged on the inner wall lower portion, a third light strip arranged on the inner wall lower portion, and a fourth light strip arranged on the outer wall lower portion.
  • Each of the first light strip, the second light strip, the third light strip, and the fourth light strip comprising light sources, and each light source is configured to emit light having a wavelength of 441 nm to 459 nm at an intensity of 98 mW/cm 2 to 102 mW/cm 2 . Additionally, each light source has a height no greater than 0.8mm and a viewing angle of at least 125 degrees.
  • the method further includes inserting the body into a mouth of a user, pressing an initiator switch configured to initiate illumination of the light sources upon being pressed, determining with a timing circuit that a predetermined time has elapsed, and, in response to the determination that a predetermined time has elapsed, ceasing illumination of the light sources.
  • FIG. 1 shows a top perspective view of an exemplary embodiment of an intraoral device including a body and a handle.
  • FIG. 2 shows a bottom right perspective view of the intraoral device shown in FIG. 1.
  • FIG. 3 shows a perspective view of the body of the intraoral device shown in FIG. 1 with the handle removed.
  • FIG. 4 shows a perspective view of the body of the intraoral device shown in FIG. 1 with an outer portion removed.
  • FIG. 5A shows a top view of a frame of the body shown in FIG. 4.
  • FIG. 5B shoes a bottom view of the frame of the body shown in FIG. 4.
  • FIG. 6 shows a top view of the body shown in FIG. 4.
  • FIG. 7 shows a bottom view of the body shown in FIG. 4.
  • FIG. 8 shows a rear cross-sectional view of the body shown in FIG. 4 taken along the line 8—8 in FIG. 6.
  • FIG. 9 shows another rear cross-sectional view of the body shown in FIG. 4 taken along the line 9—9 in FIG. 6.
  • FIG. 10 shows a cross-sectional view of the body shown in FIG. 4 along the line 10—
  • FIG. 11 shows an exploded view of the intraoral device shown in FIG. 1.
  • FIG. 12 schematically shows an exemplary light strip disposed in the body of the intraoral device of FIG. 1.
  • FIG. 13 schematically shows a top view of the light strip disposed in the body of the intraoral device of FIG. 1.
  • FIG. 14 schematically shows circuitry of the intraoral device shown in FIG. 1.
  • FIG. 15 shows a method of manufacturing an intraoral device.
  • FIG. 16 shows a method of use of an intraoral device.
  • FIG. 17A shows a top view of a prototype of the body of the intraoral device of FIG.
  • FIG. 17B shows a bottom view of the prototype of FIG. 17A.
  • FIG. 18 shows exemplary light strips of the prototype of the FIG. 17A.
  • FIG. 19 shows graphs illustrating the effect of different wavelengths on the number of bacterial cells.
  • FIG. 20 shows a graph illustrating the effect of the energy level of light relative to the number of pathogens.
  • FIG. 21 shows a graph illustrating the efficiency of several exemplary LEDs relative to the current applied.
  • FIG. 22 shows a table illustrating several characteristics of exemplary LEDs.
  • FIGS. 23-28 shows graphs illustrating the intensity output of different combinations of LED spacings and currents.
  • FIG. 29 shows a table illustrating the relationship between the spacing of the LEDs and several performance characteristics.
  • FIG. 30 shows a graph illustrating the intensity output of an LED strip relative to the gap distance from the light strip and a sensor.
  • FIG. 31 shows a graph illustrating the intensity output of an LED strip disposed on a curved outer surface.
  • FIG. 32 shows a graph illustrating the intensity output of the LED strip shown in FIG. 31 with adjusted resistances.
  • FIG. 33 shows a graph illustrating the intensity output of the LED strip disposed on a curved inner surface.
  • FIG. 1 and FIG. 2 are top and bottom perspective views, respectively, of an exemplary intraoral device 100.
  • the intraoral device 100 may be configured to emit light inside a user’s mouth. Emitted light may clean and/or whiten the user’s teeth.
  • the intraoral device 100 may include a body 104 and a handle 108.
  • the body 104 is positioned inside the mouth of a user while the handle 108 remains outside the user’s mouth.
  • a top portion 105 of the intraoral device 100 and a bottom portion 106 of the intraoral device 100 are not symmetrical. Because the body 104 is not symmetrical, it is arranged to be used in a single orientation.
  • the body 104 includes an outer portion 198 (e g., an overmold), a frame 202, a plurality of light sources 140, and, in some instances, a bite switch 124 (FIG. 1).
  • the frame 202 supports the light sources 140 and the bite switch 124, if included.
  • the outer portion 198 encloses the frame 202, the light sources 140, and the bite switch 124, if included.
  • the body 104 may surround and output light to the user’s teeth.
  • FIG. 4- FIG. 5B show various views of the frame 202.
  • the frame 202 includes an inner frame wall 232, an outer frame wall 236, and a support wall 240, which couples the inner frame wall 232 to the outer frame wall 236.
  • apertures 242 may extend through the inner frame wall 232 and apertures 243 may extend through the outer frame wall 236.
  • the frame 202 may be formed from a first material, which is generally rigid.
  • the first material may be medical grade acrylonitrile butadiene styrene (ABS). In other instances, other suitable medical grade materials may be used.
  • ABS medical grade acrylonitrile butadiene styrene
  • the apertures 242, 243 reduce the weight of the frame 202.
  • the frame 202 is generally U-shaped and therefore includes a central portion 202a, a first side portion 202b, and a second side portion 202c.
  • the central portion 202a is generally arcuate.
  • the first and second side portions 202b, 202c extend from opposite sides of the central portion 202a to distal ends 202d, 202e.
  • the support wall 240 only extends along a portion of the frame 202, such that gaps 202f, 202g exists between the inner frame wall 232 and the outer frame wall 236. In this instance, the support wall 240 extends along the central portion 202a and the gaps 202f, 202g are present between the inner and outer frame walls 232, 236 from the central portion 202a and the respective distal ends 202d, 202e. In other instances, the support wall 240 may extend along the entire frame 202 or a majority of the frame 202.
  • the support wall 240 includes an upper support wall 240a (FIG. 5A) and a lower support wall 240b (FIG. 5B).
  • the inner frame wall 232 includes projections 234 that extend toward the outer frame wall 236, and the outer wall 236 includes projections 238 that extend toward the inner frame wall 232.
  • the projections 234, 238 are positioned at or adjacent to the distal ends 202d, 202f of the first and second side portions 202b, 202c, respectively.
  • the projections 234, 238 are positioned at generally the same vertical height as the support wall 240 relative to the inner frame wall 232 and outer frame wall 236.
  • the projections 234, 238 lend additional support to the body 104, once formed. In other embodiments, the projections 234, 238 may be positioned elsewhere along the inner and outer frame walls 232, 236 or omitted.
  • the upper support wall 240a defines a generally horizontal plane Pl.
  • upper surfaces of the projections 234, 238 are in the horizontal plane Pl as well.
  • the lower support wall 240b defines a generally horizontal plane P2.
  • lower surfaces of the projections 234, 238 are in the horizontal plane P2, as well.
  • the planes Pl, P2 are generally parallel to one another. In other embodiments, the planes Pl, P2 may be oriented at a non-parallel angle relative to another.
  • the bite switch 124 is supported on the upper support wall 240a. In other cases, the bite switch 124 may be supported on the lower support wall 240b. In still other cases, one or more bite switches 124 may be supported by a surface of one or more of the projections 234, 238. In some implementations, there is no bite switch 124.
  • the inner frame wall 232 includes an upper inner frame wall 232a and a lower inner frame wall 232b
  • the outer frame wall 236 includes an upper outer frame wall 236a and a lower outer frame wall 236b.
  • the upper inner frame wall 232a and the upper outer frame wall 236a are above the upper support wall 240a
  • the lower inner frame wall 232b and the lower outer frame wall 236b are above the lower support wall 240b.
  • the upper outer frame wall 236a includes a planar inner surface that defines a plane P3.
  • the lower outer frame wall 236b includes a planar inner surface that extends within the plane P3.
  • the plane P3 is perpendicular to the horizontal planes Pl, P2 defined by the upper and lower support walls 240a, respectively. Accordingly, as shown, except that the upper outer frame wall 236a and the lower outer frame wall 236b have different heights, the upper outer frame wall 236a is generally symmetrical with the lower outer frame wall 236b about the horizontal planes Pl, P2.
  • the plane P3 of the planar inner surfaces of the upper inner wall 236a and the lower inner wall 236b may form an oblique angle relative the respective planes Pl, P2.
  • the planar inner surfaces of the upper inner wall 236a and the lower inner wall 236b may not extend in the same plane, but instead extend in different planes, which may be oriented at perpendicular or oblique angles relative to the respective planes Pl, P2.
  • the upper inner frame wall 232a includes an inner surface.
  • the inner surface of the upper inner frame wall 232a gradually transitions from being generally planar at or adjacent to the distal ends 202d, 202e to non-planar or arcuate in the central portion.
  • the inner surface of the upper inner frame wall 232a defines a plane P4.
  • the plane P4 is generally coincident with the inner surface.
  • the plane P4 is tangential thereto.
  • the plane P4 is positioned at an angle 01 relative to the horizontal plane Pl of the upper support wall 240a.
  • the angle 91 of the plane P4 of the inner surface of the upper inner frame wall 232a increases from the central portion 202a to the distal ends 202d, 202f.
  • the angle 01 at the central portion is 150 degrees and the angle 91 at the distal ends 127d, 127e is 94 degrees.
  • the angle 01 at the central portion may range from 90 degrees to 180 degrees and the angle 01 at the distal ends 127d, 127e may range from 90 degrees to 180 degrees.
  • the angle 01 at the central portion may range from 140 degrees to 160 degrees and the angle 01 at the distal ends 127d, 127e may range from 90 degrees to 100 degrees.
  • the lower inner frame wall 232b includes an inner surface.
  • the inner surface of the lower inner frame wall 232b gradually transitions from being generally planar at or adjacent to the distal ends 202d, 202e to non-planar or arcuate at in the central portion 202a.
  • the inner surface of the lower inner frame wall 232b defines a plane P5.
  • the plane P5 is generally coincident with to the inner surface.
  • the plane P5 is tangential thereto.
  • the plane P5 is positioned at an angle 02 relative to the horizontal plane P2 of the lower support wall 240b.
  • the angle 02 of the plane P5 of the inner surface of the lower inner frame wall 232b increases from the central portion 202a to the distal ends 202d, 202f.
  • the angle 02 at the central portion is 120 degrees and the angle 02 at the distal ends 127d, 127e is 94 degrees.
  • the angle 02 at the central portion may range from 90 degrees to 180 degrees and the angle 02 at the distal ends 127d, 127e may range from 90 degrees to 180 degrees.
  • the angle 02 at the central portion may range from 110 degrees to 130 degrees and the angle 02 at the distal ends 127d, 127e may range from 90 degrees to 100 degrees.
  • the angle 02 corresponding to the plane P5 of the lower inner frame wall 232b may be greater than or equal to the angle 01 corresponding to the plane P4 of the upper inner frame wall 232.
  • the angles 01, 02 of the of the inner surfaces of the upper inner frame wall 232a and the lower inner frame wall 232b are different in the central portion 202a.
  • the angles 01, 02 of the of the inner surfaces of the upper inner frame wall 232a and the lower inner frame wall 232b are the same adjacent to the distal ends 202d, 202e. Accordingly, as shown, the upper inner frame wall 232a is generally asymmetrical with respect to the lower inner frame wall 232b about the horizontal planes Pl, P2.
  • angles 01, 02 of the of the inner surfaces of the upper inner frame wall 232a and the lower inner frame wall 232b are different in the central portion 202a.
  • the angles 01, 02 of the of the inner surfaces of the upper inner frame wall 232a and the lower inner frame wall 232b may be different or the same adjacent to the distal ends 202d, 202e.
  • the curvature of the upper inner frame wall 232a is greater than the curvature of the upper outer frame wall 236a.
  • the curvature of the lower inner frame wall 232b is greater than the curvature of the lower outer frame wall 236b. That is, the radius of the upper inner frame wall 232a is smaller than the radius of the upper outer frame wall 236a, and the radius of the lower inner frame wall 232b is smaller than the radius of the lower outer frame wall 236b.
  • the body 104 includes a first light strip 130, a second light strip 132, a third light strip 134, and a fourth light strip 134, each including some of the plurality of light sources 140.
  • the first light strip 130 is coupled to the upper inner frame wall 232a
  • the second light strip 132 is coupled to the upper outer frame wall 236a
  • a third light strip 134 is coupled to the lower inner frame wall 232b
  • a fourth light strip 136 is coupled to the lower outer frame wall 236b.
  • the light strips 130-136 are configured to provide power to the light sources 140 disposed on any of the first light strip 130, the second light strip 132, the third light strip 134, or the fourth light strip 136.
  • Each of the first light strip 130, the second light strip 132, the third light strip 134, and the fourth light 136 include light sources 140.
  • the light sources 140 are light-emitting diodes (LEDs).
  • the LEDs 140 of the first light strip 130 and the third light strip 134 are vertically aligned and the LEDs 140 of the second light strip 132 and the fourth light strip 136 are vertically aligned.
  • the LEDs 140 of the first light strip 130 may be staggered relative to the LEDs 140 of the third light strip 134 and the LEDs 140 of the second light strip 132 may be staggered relative to LEDs 140 the fourth light strip 136.
  • each LED 140 of the first light strip 130 may be positioned between adjacent LEDs of the third light strip 134, and each LED 140 of the second light stirp 132 may be positioned between adjacent LEDs 140 of the fourth light strip 138.
  • each LED 140 of the first light strip 130 may be positioned halfway between adjacent LEDs of the third light strip 134, and each LED 140 of the second light stirp 132 may be positioned halfway between adjacent LEDs 140 of the fourth light strip 138.
  • each LED 140 of the first light strip 130 may be positioned 2.5 mm from both adjacent LEDs of the third light strip 134, and each LED 140 of the second light stirp 132 may be positioned 2.5 mm from both adjacent LEDs 140 of the fourth light strip 138.
  • Other configurations are contemplated.
  • the light strips 130, 132, 134, 136 conform to the respective shape of the surfaces of the respective wall 232a, 232b, 236a, 236b such that the light sources 140 are configured to emit light away from the respective wall 232a, 232b, 236a, 236b toward the channel 248.
  • the respective light strips 132, 136 have a generally rectangular shape prior to being assembled and are there able to conform to the planar inner surfaces of the respective outer frame wall 236a, 236b. Also, the respective light strips 130, 134 are generally U-shaped prior to being assembled and are there able to conform to the inner surfaces of the respective inner frame wall 232a, 232b.
  • the first light strip 130 includes concavity having a radius Rl
  • the third light strip 134 includes a concavity having a radius R2, which is greater than RL
  • the concavities (e.g., radii Rl, R2) of the first and third light strips 130, 134 are greater than that of the second and fourth light strips 132, 136 so the light strips 130, 132, 134, 136 conform to the respective walls 232a, 232b, 236a, 236b.
  • the LEDs 140 of the second light strip 132 and the fourth light strip 136 each have an inner surface through which light is emitted.
  • the inner surface of each LED 140 defines a plane that is generally parallel to the planar inner surface of the respective upper and lower outer frame wall 236a, 236b to which its coupled. Therefore, the plane of the inner surface of each LED 140 is perpendicular to horizontal planes Pl, P2 defined by the upper and lower surfaces of the support wall 240a.
  • the inner surface of each LED 140 of the first light strip 130 defines a plane that is parallel to the plane P4 of the upper inner frame wall 232a. Therefore, each LED is also positioned at the angle 01 of upper inner frame wall 232b.
  • the inner surface of each LED 140 of the third light strip 134 defines a plane that is parallel to the plane P5 of the lower inner frame wall 232b. Therefore, each LED is also positioned at the angle 92 of the lower inner frame wall 232b.
  • the outer portion 198 of the body 104 encloses the frame 202 and the light strips 130, 132, 134, 136.
  • the outer portion 198 also encloses the bite switch 124, when present.
  • the outer portion 198 generally conforms to the shape of the frame 202.
  • the light from the light sources 140 is configured to emit through the outer portion 198, as will be discussed below.
  • the outer portion 198 is constructed from a second material that is generally less rigid than the frame 202.
  • the second material may be medical grade thermoplastic elastomer (TPE).
  • TPE thermoplastic elastomer
  • the second material may be another medical grade material in other embodiments.
  • the second material is transparent, such that light from the light sources 140 emit through the outer portion 198.
  • the body 104 like the frame 202, includes an inner wall 112, an outer wall 116, and a bite surface 120.
  • the bite surface 120 defines an upper bite surface 120a and a lower bite surface 120b.
  • the upper bite surface 120a and the lower bite surface 120b are configured to support the user’s teeth.
  • each of the upper and lower bite surfaces 1200a, 120b is relatively flat.
  • the upper bite surface 120a is defined in a horizontal plane P6 (FIGS. 8-10) that is parallel to the horizontal plane Pl of the upper support wall 240a of the frame 202.
  • the lower bite surface 120b is defined in a horizontal plane P7 (FIGS. 8-10) that is parallel to the horizontal plane P2 of the lower support wall 240b of the frame 202.
  • the horizontal plane P6 may be coincident with the horizontal plane Pl of the upper support wall 240a and the horizontal plane P7 may be coincident with the horizontal plane P2 of the lower support wall 240b.
  • the bite surface 120 may include variations in order to accommodate different tooth configurations and sizes.
  • the body 104 includes an upper inner wall 112a and an upper outer wall 116a disposed above the upper bite surface 120a.
  • the opposite facing sides of the upper inner wall 112a and the upper outer wall 116a are adjacent to the upper bite surface 120a and define an upper channel 128a.
  • the upper inner wall 112a conforms to the shape of the upper inner frame wall 232a and the upper outer wall 116a conforms to the shape of the upper inner frame wall 236a.
  • the body 104 may define a lower inner wall 112b, a lower outer wall 116b disposed below the lower bite surface 120b.
  • the opposite facing sides of the lower inner wall 112b and the lower outer wall 116b are adjacent to the lower bite surface 120b and define a lower channel 128b.
  • the lower inner wall 112b conforms to the shape of the lower inner frame wall 232b and the lower outer wall 116b conforms to the shape of the lower inner frame wall 236b.
  • the body 104 is generally U-shaped, from a top view, and includes a central portion 127a, a first side portion 127b, and a second side portion 127c.
  • the central portion 127a is arcuate.
  • the first and second side portions 127b, 127c extend from opposite sides of the central portion 127a to distal ends 127e, 127f.
  • the upper channel 128a and the lower channel 128b at least partially receive the user’s teeth when the body 104 is inserted into the user’s mouth. More specifically, the upper channel 128a at least partially encompasses the upper teeth of the user and the lower channel 128b at least partially encompasses the lower teeth of the user.
  • the outer wall 116 is configured to partially surround the outer portion of the user’s teeth such that the light sources 140 of the second light strip 132 and the fourth light strip 136 output light towards the outer portion of the user’s teeth.
  • the outer wall 116 like the outer wall 236 of the frame 202, extends perpendicularly away from the upper bite surface 120a and the lower bite surface 120b.
  • the upper outer wall 116a has a planar inner surface (which faces the upper channel 128a) that is perpendicular to the horizontal plane P6 of the upper bite surface 120a.
  • the lower outer wall 116b has a planar inner surface (which faces the lower channel 128b) that is perpendicular to the horizontal plane P7 of the lower bite surface 120b. Additionally, as shown, except that the upper outer wall 116a and the lower outer wall 116b have different heights, the outer lower wall 116a is generally symmetrical with the outer lower wall 116b about the horizontal planes P6, P7. In other embodiments, the planar inner surfaces of the outer wall 116 may extend at oblique angles relative to the respective planes P6, P7.
  • the inner wall 112 is configured to partially surround the inner portion of the user’s teeth such that the light sources 140 of the first light strip 130 and the third light strip 134 output light towards the inner portion of the user’s teeth.
  • the upper inner wall 112a includes an inner surface that faces the upper channel 128a.
  • the inner surface of the upper inner wall 112a gradually transitions from being generally planar at or adjacent to the distal ends 127d, 127e to non-planar or arcuate in the central portion 127a.
  • the plane is generally coincident with the inner surface.
  • the plane is tangential thereto.
  • the plane of the upper inner wall 112a is parallel to the corresponding plane P4 of the upper inner frame wall 232a. Therefore, at each location along the upper inner wall 112a, the plane of the upper inner wall 112a, like the corresponding plane P4, is positioned at an angle 01 relative to the horizontal plane P6 of the upper bite surface 120a, since the horizontal plane P6 is parallel to the horizontal plane Pl of the upper support wall 240a. As shown in FIGS. 8-10, the angle 01 of the plane of the inner surface of the upper inner wall 112a increases from the central portion 127a to the distal ends 127d, 127e.
  • the lower inner wall 112b includes an inner surface, which faces the lower channel 128b.
  • the inner surface of the lower inner wall 112b transitions from being generally planar at or adjacent to the distal ends 127d, 127e to non-planar or arcuate in the central portion 127a.
  • the plane is generally coincident with the inner surface.
  • the plane is tangential thereto.
  • the plane of the lower inner wall 112b is parallel to the corresponding plane P5 of the lower inner frame wall 232b.
  • the plane of the lower inner wall 112b is positioned at an angle 02 relative to the horizontal plane P7 of the lower bite surface 120b, since the horizontal plane P7 is parallel to the horizontal plane P2 of the lower support wall 240b.
  • the angle 02 of the plane of the inner surface of the lower inner wall 112b increases from the central portion 127a to the distal ends 127d, 127e.
  • the angles 02 corresponding to the plane of the lower inner wall 112b may be greater than or equal to the angles 01 corresponding to the plane of the upper inner wall 112a.
  • the angles 01, 02 of the of the inner surfaces of the upper inner wall 112a and the lower inner wall 112b are different in the central portion 127a and the angles 01, 02 of the of the inner surfaces of the upper inner frame wall 112a and the lower inner wall 112b are the same adjacent to the distal ends 127d, 127e.
  • the upper inner wall 112a is generally asymmetrical with respect to the lower inner wall 112b about the horizontal planes P6, P7.
  • angles 01, 02 of the of the inner surfaces of the upper inner wall 112a and the lower inner wall 112b may be different or the same in the central portion 127a.
  • the angles 01, 02 of the of the inner surfaces of the upper inner wall 112a and the lower inner wall 112b may be different or the same adjacent to the distal ends 127d, 127e.
  • the curvature of the upper inner wall 112a is greater than the curvature of the upper outer wall 116a.
  • the curvature of the lower inner wall 112b is greater than the curvature of the lower outer wall 116b. That is, the radius of the upper inner wall 112a is smaller than the radius of the upper outer wall 116a, and the radius of the lower inner wall 112b is smaller than the radius of the lower outer wall 116b.
  • the walls 112a, 112b, 116a, 116b may have other configurations, while still supporting the frame 202 and the lights sources 140 thereof.
  • the walls 112a, 112b, 116a, 116b may be positioned differently relative to the frame 202.
  • one or more of the surfaces of walls 112a, 112b, 116a, 116b may be oriented at different angles than those at which the corresponding wall 232a, 232b , 236a, 236b of the frame 202 is oriented.
  • the bite surface may define one or more openings, which may allow saliva to flow through the body 104.
  • the bite surface may define at least two openings 122 (FIGS. 6-7) extending between the upper bite surface 120a and the lower bite surface 120b. These openings 122 may be for the user’s canine teeth and/or to allow saliva to pass through.
  • the exemplary bite switch 124 may include one or more sensors configured to determine when the body 104 is in the user’s mouth.
  • the bite switch 124 may be accessible via the upper bite surface 120a or the lower bite surface 120b of the body 104.
  • a signal from the bite switch 124 may be used to control the plurality of light sources of the mouthpiece.
  • the light strips 130, 132, 134, 136, and the LEDs 140 supported thereby may be spaced apart from the respective upper and lower bite surface 120a, 120b.
  • the light strips 132, 136, and the light sources 140 thereof, corresponding to the outer wall 116 may be located further away from the respective bite surface 120a, 120b than the light strips 130, 134, and the light sources 140 thereof, corresponding to the inner wall 112.
  • the first light strip 130 may be arranged closer to the bite surface 120 than the second light strip 132
  • the third light strip 134 may be arranged closer to the bite surface 120 than the fourth light strip 136.
  • the light strips 130, 132, 134, 136 may be spaced apart from the respective upper and lower bite surface 120a, 120b by the same distance.
  • the light strips 130-136 are disposed inside the body 104 (supported by the frame 202) in the exemplified embodiment. In other embodiments, the light strips 130-136 may be arranged on the surface of the body 104, and in particular, the outer portion of the body 104.
  • the light sources 140 are configured to emit light towards the user’s teeth.
  • the light sources have a height of 0.7mm.
  • exemplary light sources may have a height of 0.4mm to 1.2mm.
  • exemplary light sources have a height no greater than 0.8 mm.
  • exemplary light sources have a height no greater than 0.7mm; a height no greater than 0.6mm; or a height no greater than 0.5mm.
  • exemplary light sources have a height of at least than 0.4mm; a height of at least 0.5mm; a height of at least 0.6mm; a height of at least 0.7mm; or a height of at least 0.8 mm.
  • Exemplary light sources are configured to provide an energy density of more than 6 Joules per square centimeter (J/cm 2 ).
  • exemplary light sources 140 are configured to provide an energy density no less than 16 J/cm 2 and no greater than 54 J/cm 2 ; no less than 18 J/cm 2 and no greater than 48 J/cm 2 ; no less than 24 J/cm 2 and no greater than 45 J/cm 2 ; or no less than 36 J/cm 2 and no greater than 54 J/cm 2 .
  • exemplary light sources 140 are configured to provide an energy density of no less than 18 J/cm 2 ; no less than 24 J/cm 2 ; no less than 30 J/cm 2 ; no less than 36 J/cm 2 ; no less than 42 J/cm 2 ; no less than 48 J/cm 2 ; or no less than 54 J/cm 2 .
  • exemplary light sources 140 are configured to provide an energy density of no greater than 54 J/cm 2 ; no greater than 48 J/cm 2 ; no greater than 42 J/cm 2 ; no greater than 36 J/cm 2 ; no greater than 30 J/cm 2 ; no greater than 24 J/cm 2 ; or no greater than 16 J/cm 2 .
  • exemplary light sources 140 are configured to emit light having a wavelength no less than 441 nm and no greater than 459 nm; no less than 443 nm and no greater than 457; no less than 445 nm and no greater than 455 nm; no less than 447 nm and no greater than 453 nm; or no less than 449 nm and no greater than 451 nm.
  • light sources 140 are configured to emit light having a wavelength of no greater than 459 nm; no greater than 457 nm; no greater than 455 nm; no greater than 453 nm; no greater than 451 nm; no greater than 449 nm; no greater than 447 nm; no greater than 445 nm; no greater than 443 nm; or no greater than 441 nm.
  • light sources 140 are configured to emit light having a wavelength of no less than 459 nm; no less than 457 nm; no less than 455 nm; no less than 453 nm; no less than 451 nm; no less than 449 nm; no less than 447 nm; no less than 445 nm; no less than 443 nm; or no less than 441 nm.
  • exemplary light sources 140 are configured to emit light at an intensity of no less than 95 mW/cm 2 and no greater than 105 mW/cm 2 ; no less than 97 mW/cm 2 and no greater than 103 mW/cm 2 ; or no less than 99 mW/cm 2 and no greater than 101 mW/cm 2 .
  • light sources 140 are configured to emit light at an intensity no greater than 105 mW/cm 2 ; no greater than 103 mW/cm 2 ; no greater than 101 mW/cm 2 ; no greater than 99 mW/cm 2 ; or no greater than 97 mW/cm 2 .
  • light sources 140 are configured to emit light at an intensity no less than 95 mW/cm 2 ; no less than 97 mW/cm 2 ; no less than 99 mW/cm 2 ; no less than 101 mW/cm 2 ; or no less than 103 mW/cm 2 .
  • exemplary light sources 140 are configured to emit light at a viewing angle of between 125 degrees and 132 degrees. In various implementations, exemplary light sources 140 are configured to emit light at a viewing angle of no less than 125 degrees; no less than 127 degrees; no less than 129 degrees; or no less than 130 degrees. In various implementations, exemplary light sources 140 are configured to emit light at a viewing angle of no greater than 132 degrees; no greater than 131 degrees; no greater than 130 degrees; no greater than 129 degrees; no greater than 128 degrees; or no greater than 127 degrees.
  • the forward voltage of each light source is no greater than 3 Volts.
  • exemplary light sources 140 are configured to have a forward voltage no less than 2.0 Volts or no less than 1.8 Volts.
  • exemplary light sources 140 are configured to have a forward voltage no greater than 3.1 Volts; no greater than 3.2 Volts; no greater than 3.3 Volts; or no greater than 3.4 Volts.
  • exemplary light sources 140 are configured to have a drive current no less than 10 mA and no greater than 30 mA; no less than 12 mA and no greater than 28 mA; no less than 14 mA and no greater than 26 mA; no less than 16 mA and no greater than 24 mA; no less than 18 mA and no greater than 22 mA.
  • exemplary light sources 140 are configured to have a drive current no less than 10 mA; no less than 12 mA; no less than 14 mA; no less than 16 mA; no less than 18 mA; no less than 24 mA; or no less than 28 mA.
  • exemplary light sources 140 are configured to have a drive current no greater than 30 mA; no greater than 28 mA; no greater than 26 mA; no greater than 24 mA; no greater than 22 mA; no greater than 18 mA; or no greater than 14 mA.
  • the light sources 140 are disposed on the light strips 130-136 which may be disposed within the body 104. Accordingly, the light emitted by the light sources 140 would emit through a portion of the body 104 before reaching the surface of the user’s teeth.
  • the offset distance D between the light sources 140 and the outer surface of the body 104 in the exemplified embodiment may be between 1 .75 mm to 2.25 mm. This specific offset distance D is based on the specifications of the light sources 140 and may accordingly change based on the light sources used.
  • the light sources may be arranged evenly along the first light strip 130.
  • the light sources may be arranged evenly along the second light strip 132.
  • the light sources may be arranged evenly along the third light strip 134.
  • the light sources may be arranged evenly along the fourth light strip 136.
  • the gap distance DI between each light source disposed on any of the plurality of light strips 130-136 is the horizontal distance between opposite edges of the adjacent light source 140. In other words, the gap distance DI measures the gap between adjacent light sources. In some implementations, the gap distance DI is the same for each of the first light strip 130, the second lights strip 132, the third light strip 134, and the fourth lights strip 136.
  • the first light strip 130 and the third light strip 134 of the inner wall 112 have fewer LEDs than the second light strip 132 and the fourth light strip 136 of the outer wall 116.
  • the first light strip 130 and the third light strip 134 of the inner wall 112 each have ten LEDs
  • the second light strip 132 and the fourth light strip 136 of the outer wall 116 each have fourteen LEDs.
  • the quantity of LEDs in each of the first light strip 130, the second lights strip 132, the third light strip 134, and the fourth lights strip 136 correlates to the gap distance DI between adjacent LEDs.
  • a greater gap distance DI between adjacent LEDs results in fewer LEDs per light strip 130, 132, 134, 136, while a smaller gap distance DI between adjacent LEDs results in more LEDs per light strip 130, 132, 134, 136.
  • the exemplary gap distance DI between each light source 140 is no less than 3 mm and less than 7 mm; or no less than 4mm and no greater than 6mm. In various implementations, the exemplary gap distance DI between each light source 140 is no less than 3 mm; no less than 4 mm; no less than 5 mm; no less than 6 mm; or no less than 7 mm. In various implementations, the exemplary gap distance DI between each light source 140 is no greater than 7 mm; no greater than 6mm; no greater than 5 mm; or no greater than 4 mm. [0098] With reference to FIG. 11, the handle 108 may be configured to house electronic components that operate the plurality of light sources in the body 104. The handle 108 includes a handle housing 148 and a cap 152. When assembled, the body 104 is coupled to a circuit board 154. When assembled, the circuit board 154 is coupled to a battery 158.
  • the handle 108 includes a charging port 162 and a power button 166.
  • An LED indicator may surround power button 166.
  • the handle 108 may incorporate fewer or additional components and have a different structure.
  • the handle 108 is coupled to the body 104 by a fastener 170.
  • the handle 108 may be constructed and coupled to the body 104 using a different methodology (e.g., friction fitting, adhesives, etc ).
  • the handle housing 148 is configured to house the circuit board 154 and the battery 158 apart from the body 104 such that the circuit board 154 and the battery 158 are disposed outside of the user’s mouth.
  • the handle housing 148 may be waterproof or water resistant. In other embodiments, the handle may incorporate different forms or shapes.
  • the cap 152 is configured to removably couple to the handle housing 148 such that the handle housing 148 and cap 152 surround and protect the circuit board 154 and the battery 158.
  • the cap 152 incorporates a friction fit to couple to the handle housing 148.
  • the cap 152 may include fasteners or other methodologies to removably couple the cap 152 to the handle housing 148.
  • FIG. 14 schematically shows exemplary electrical components and electrical communications between exemplary components.
  • the circuit board 154 is configured to control the plurality of light sources and regulate the power of the battery 168.
  • the circuit board 154 includes a timing circuit 174, a power MOSFET 178, a linear voltage regulator 182, and a battery charging integrated circuit (“IC”) 186.
  • the circuit board 154 may incorporate fewer or additional components in order to account for fewer or additional functionalities, form factors, and power efficiencies.
  • the battery 158 is configured to power the plurality of light sources.
  • Various battery types may be used.
  • the battery 158 may use a lithium-polymer chemistry to power the plurality of light sources.
  • the battery 158 comprises a single cell.
  • the battery 158 may utilize a different chemistry and have a different shape or capacity.
  • the battery 158 may have a capacity between 350 mAh to 700 mAh and a nominal voltage of approximately 3.7 volts.
  • the charging port 162 is configured to receive an external power source to charge the battery 158.
  • the charging port 162 may be compatible with various charging architectures (such as micro-USB, USB-C, USB-A, etc.).
  • the power button 166 may be in electrical communication with various electrical components.
  • the power button 166 may be in electrical communication with the battery 158 and with the timing circuit 174.
  • the indicator is configured to notify the user when a predetermined amount of time has passed.
  • the indicator may also notify the user if an error has occurred, provide information about the battery state (e.g., charge), and allow the user to operatively adjust the timing.
  • the handle 108 may use a buzzer or display screen as an indicator instead of or in addition to the LED indicator.
  • the indicator may be configured to provide various colors of light, such as red, yellow, green, etc.
  • the timing circuit 174 is configured to determine that a predetermined period of time has elapsed. In some embodiments, upon determining that a predetermined amount of time has elapsed since initiation of the flow of electricity, the timing circuit 174 sends a signal to the indicator to notify the user to remove the intraoral device 100. In some embodiments, the timing circuit may directly shut off the light sources 140 after determining the predetermined period of time has passed.
  • the light sources 140 may be part of a light source assembly 141. Accordingly, each of the light strips 130, 132, 134, 136 discussed above may include a plurality of light sources assemblies 141.
  • the light source assemblies 141 may receive power from linear voltage regulator 182.
  • light source assemblies 141 include the light sources 140 (shown as LEDs) and resistors 143.
  • each LED 140 is paired with a resistor 143 that is used to set the current (and thus the irradiance) of the LED 140. By selecting the values of resistors 143 used for each LED 140 in the mouthpiece, the intensity of the light on the oral surfaces can be carefully controlled and balanced for consistency.
  • Exemplary resistors 143 may have a resistance between 2.7 Ohms and 5.5 Ohms in some embodiments and a resistance between 3.0 Ohms and 5.5 Ohms in other embodiments. In various implementations, resistors 143 may have a resistance of no less than 2.7 ; no less than 3.0 Ohms; no less than 3.2 Ohms; no less than 3.8 Ohms; no less than 4.4 Ohms; or no less than 5.0 Ohms. In various implementations, resistors 143 may have a resistance of no greater than 5.5 Ohms; no greater than 5.0 Ohms; no greater than 4.5 Ohms; no greater than 4.0 Ohms; or no greater than 3.5 Ohms.
  • resistors 143 having multiple difference resistance values may be used.
  • a light strip may include a combination of resistors 143 having a resistance between 4.8 Ohms and 5.2 Ohms as well as resistors 143 having a resistance between 2.7 Ohms and 3.5 Ohms.
  • a light strip may include a combination of resistors 143 having a resistance between 4.8 Ohms and 5.2 Ohms as well as resistors 143 having a resistance between 3.0 Ohms and 3.5 Ohms. Other values and combinations are contemplated.
  • the resistors 143 associated with LEDs in the middle portion 127 of the inner wall 112 have a lower resistance value than resistors 143 corresponding with LEDs outside of the middle portion 127 of the inner wall 112 (e.g., the upper inner wall 112a).
  • light sources 140 may be illuminated for no less than 60 seconds and no greater than 180 seconds; no less than 90 seconds and no greater than 180 seconds; or no less than 120 seconds and no greater than 180 seconds. In various implementations, light sources 140 may be illuminated for no less than 60 seconds; no less than 90 seconds; no less than 120 seconds; no less than 150 seconds; or no less than 180 seconds. In various implementations, light sources 140 may be illuminated for no greater than 180 seconds; no greater than 150 seconds; no greater than 120 seconds; no greater than 90 seconds; or no greater than 60 seconds.
  • the power MOSFET 178 is configured to control the charge and discharge of the battery 158. In some embodiments, the power MOSFET 178 may be operably controlled by the user to activate or disactivate the light sources 140.
  • the linear voltage regulator 182 is configured to regulate the voltage output of the battery 158 in order to control the current sent to the light sources 140. In some embodiments, the linear voltage regulator 182 may not be present.
  • the battery charging integrated circuit (IC) 186 is configured to control the flow of power from the charging port 162 to the battery 158. For example, the battery charging IC 186 may reduce the power input from the charging port 162 based on the charging voltage of the battery 158.
  • FIG. 15 shows an exemplary method 200 of manufacturing the intraoral device 100.
  • the intraoral device 100 may be manufactured using other methodologies and the method of manufacturing 200 may be utilized to manufacture other intraoral devices.
  • Exemplary method 200 begins with a first operation 204 to provide the frame 202. Then, the frame 202 is coupled to the first light strip 130 in operation 208, the second light strip 132 in operation 212, the third light strip 134 in operation 216, and the fourth light strip 136 in operation 220. After the frame 202 is coupled to the plurality of light strips 130-136, operation 224 includes forming the body 104 by molding over, with the material of the outer portion 198, the frame 202, the first light strip 130, the second light strip 132, the third light strip 134, and the fourth light strip 136.
  • each of the first light strip 130, the second light strip 132, the third light strip 134, and the fourth light strip 136 included in manufacturing process 200 is the same as the respective light strips described in the intraoral device 100. Molding over the frame 202 creates the bite surfaces 120a, 120b, as disclosed above. Accordingly, the plurality of light sources 140 may incorporate the same characteristics previously described.
  • operation 206 may include coupling a bite switch 124 to the frame 202 along the support wall 240.
  • the bite switch 124 may be coupled along the upper support wall 240a and/or along the lower support wall 240b.
  • the body 104 is coupled to a battery in operation 228.
  • the handle 108 is configured to couple the battery 158 to the plurality of light sources 140 within the body 104.
  • the battery 158 is configured to power the plurality of light sources 140.
  • the battery 158 may include similar properties and features as discussed for the battery 158 of the intraoral device 100.
  • FIG. 16 shows an exemplary method 300 of operating an intraoral device.
  • the exemplary method 300 includes providing a body 104 (operation 304), inserting the body 104 into a mouth of the user (operation 308), receiving a signal from an initiator switch (operation 312) to illuminate the light sources 140 in the body 104, determining that a predetermined time has elapsed (operation 316), and providing a time elapsed indication (operation 320).
  • the user As the body 324 is inserted into the mouth of the user in operation 308, the user’s teeth enter the channel 128a, 128b of the upper portion 105 and the lower portion 106 of the body.
  • a user may select a power button 166 (also referred to as an initiator switch), which may initiate turning on main power to the device. After the body 104 is positioned within a user’s mouth, the power button 166 may be selected again. After the second selection of the power button 166, a signal is sent to a timing circuit 174 and to the plurality of light sources 140, causing the light sources 140 to illuminate.
  • a power button 166 also referred to as an initiator switch
  • the device may include a bite switch 124 in bite surface 120a, 120b, as noted above.
  • the bite switch 124 When the bite switch 124 is pressed, in operation 316, the bite switch 124 sends a signal to a timing circuit 174 and to the plurality of light sources 140, causing the light sources 140 to illuminate.
  • the timing circuit 174 Upon receiving a signal from an initiator device (e.g., from the power button or from the bite switch 124) (operation 316), the timing circuit 174 begins to count down from a predetermined time period. After the predetermined time period has elapsed, durations of which are provided above, the timing circuit 174 may send a signal to an indicator. After the predetermined time period has elapsed, durations of which are provided above, the timing circuit 174 may turn off illumination of the light sources 140.
  • FIGS. 17A and 17B which include exemplary light strips 130, 132, 134, 138 of FIG. 18. The results are discussed below.
  • LEDs emitting light wavelengths ranging from approximately 450nm to 505nm were tested at an intensity of 70 mW/cm 2 for 3 minutes on cultures of P. gingivalis, P. intermedins, F. nucleatum, and 4. actinomycetemcomitans .
  • bacterial suspensions were adjusted into 1 x 10 8 cells/mL and an aliquot of 20pL of the suspension was added into each well of a 96-well plate. The bacterial suspension was mixed with 80 pL of phosphate-buffered saline (PBS), and then irradiated by the different wavelengths.
  • PBS phosphate-buffered saline
  • LEDs Light-emitting diodes
  • the control sample was not irradiated.
  • the tested solutions were serially diluted and inoculated on an agar plate and incubated anaerobically for one week. Then a colony forming unit (CFU) was measured for each sample and determined on a per mb basis.
  • CFU colony forming unit
  • FIG. 19 shows the results of the CFU measurements per mL for bacterial cells irradiated at wavelengths of 450 nm, 470 nm, 490 nm, and 505 nm, for three minutes.
  • 450 nm blue light showed a 1 log to 5 log reduction in the number of bacterial cells compared to 470 nm, 490 nm, and 505 nm.
  • the antibacterial effect of light emitted at a wavelength of 450 nm and a wavelength of 470 nm was tested at energy outputs ranging from 6 J/cm 2 to 54 J/cm 2 .
  • the energy output was varied by adjusting the intensity of the emitted light and the time the light was applied.
  • a typical lithium-polymer battery cell can provide a nominal voltage of 3.7 volts. If the forward voltage of an LED becomes greater than 3.7 volts, multiple battery cells or additional circuitry (e.g., boost converters) may be required to power the LED. Additionally, at higher current draws, multiple battery cells may be required to provide the required power output. When the forward voltage of each light source of the intraoral device is below 3 V, the drive current is less than 30 mA.
  • FIG. 21 shows an exemplary graph illustrating the efficiency of several exemplary LEDs relative to the current applied. As shown by graph 508, the Luxeon 2835 performed better than the other tested LEDs.
  • the exemplary light source may have a peak efficiency of 0.9 milliwatts per square meter outputted per milliwatt input.
  • FIG. 22 shows an exemplary table illustrating a viewing angle, an intensity per input milliwatt, a drive current, a rectangular area, and a height of several LEDs. Each of these specifications may be a consideration in selecting an LED.
  • the viewing angle is a measure of how widely the LED spreads light. A larger viewing angle allows for each LED to provide more coverage, allowing fewer LEDs to be used, which in total will result in less power required for a similar effect.
  • the intensity shown in milliwatts per square centimeter (mW/cm 2 ) per input milliwatt, is a measure of efficiency. A greater efficiency results in less power being lost to heat.
  • the drive current (measured in milliamps) is the amount of current required to be drawn in order to output light.
  • the drive current can be used with the forward voltage to approximate the amount of power used by an LED over time.
  • the rectangular area, or size (measured in mm 2 ), of the LEDs represents the area covered by an LED or light source 140 on a wall of the intraoral device 100.
  • the height (measured in mm), as previously shown in FIG. 7 as Hl, represents the distance the LED or light source extends from the light strip toward the outer surface of the body.
  • the LED height effects the overall thickness of the body 104 because the LED is covered by the elastomer wall. A thicker body may take up more space within the user’s mouth and accordingly be uncomfortable. Additionally, a thicker body may require additional material.
  • Figs. 23-28 show example graphs illustrating the intensity output of LED strips containing different combinations of LED spacings DI and being provided different currents in order to determine the effect of multiple LEDs on the output of an LED strip.
  • the intensity of several LED strips was measured along the length of the LED strip at an offset distance D of 2 mm.
  • the LEDs were evenly spaced along a flat surface at a gap distance DI, as defined by the edge-to-edge gap DI between LEDs, of 1mm, 2mm, 3mm, 4mm, 5mm, and 7mm.
  • Each LED was provided a current of 30 mA and 50 mA.
  • the effect of different gap distances DI was tested by measuring the intensity of an LED strip along the strip.
  • the LED strip tested was the strip having a gap distance DI of 5mm.
  • the measured intensity along the LED strip generally increased the closer the strip was to the sensor.
  • the measured intensity along the LED strip was uneven.
  • the light strips were tested on approximations to the curved inner wall and the curved outer wall of the intraoral device.
  • the experiment measured the intensity of an LED strip having a 5mm gap distance DI at an offset distance D of 2mm, as determined previously for the flat strip.
  • the measured intensity significantly differed from the flat strip results.
  • the intensity of the light emitted by the LED strip formed along a curved outer surface is relatively uneven. In fact, the intensity varies at a difference of 40 mW/cm 2 between the highest and lowest recorded intensities, with the areas farther from the center generally having a higher measured intensity than the areas closer to the center of the curve. Additionally, the intensity measured at some points fell below 100 mW/cm 2 , which was previously determined to be the target minimum intensity.
  • the number of LEDs could be increased along the portions of the LED strip emitting at a lower intensity. Additionally, or alternatively, the amount of current provided to the LEDs could be increased. As shown in the exemplary graph of FIG. 32, one method of increasing the current provided, and therefore intensity of the LED strip, is to reduce the resistance of the LED.
  • the resistors of the LEDs near the center of the curve were reduced from 5 Ohms to 3.3 Ohms for one test and a combination of 3.3 Ohms and 2.7 Ohms for another test.
  • the combination of 3.3 Ohms and 2.7 Ohms resistors specifically included the centermost LEDs to be 3.3 Ohm and 2.7 Ohm resistors on opposite sides of the centermost LEDs.
  • the combination of 3.3 Ohms and 2.7 Ohms resistors specifically included two centermost LEDs measuring 3.3 Ohm and two 2.7 Ohm resistors, one on one side of the two centermost LEDs and one on the opposite side of the two centermost LEDs. Reducing the resistance on specific LEDs allows for more current to flow to specific areas of the light strip without adding additional components or changing the orientation of the LEDs disposed on the light strip. Using this configuration, the light strips tested in FIG. 32 were able to output at an intensity greater than 100 mW/cm 2
  • the intensity of the light emitted by the LED strip disposed on a curved inner surface is more consistent than the unadjusted LED strip disposed on the curved outer surface. As the intensity output consistently stayed above 100 mW/cm 2 , the resistance of each LED was not adjusted.
  • Embodiment 1 An intraoral device comprising: a body comprising an inner wall, an outer wall, and a bite surface extending between the inner wall and the outer wall, wherein the inner wall, the outer wall, and the bite surface define an upper channel and a lower channel; the inner wall comprising an inner wall upper portion and an inner wall lower portion; the outer wall comprising an outer wall upper portion and an outer wall lower portion, a first light strip supported by the inner wall upper portion; a second light strip supported by the outer wall upper portion; a third light strip supported by the inner wall lower portion; a fourth light strip supported by the outer wall lower portion; each of the first light strip, the second light strip, the third light strip, and the fourth light strip comprising light sources, each light source being configured to emit light having a wavelength of 441 nm to 459 nm at an intensity of 98 mW/cm 2 to 102 mW/cm 2 ; each light source having a height no greater than 0.8 mm; and each light source having a viewing angle of at least
  • Embodiment 2 The intraoral device according to Embodiment 1, wherein the inner wall upper portion supports a first light source, positioned at or adjacent to a first end, such that a surface of the first light source through which light is emitted defines a plane that is oriented at a first angle relative to a horizontal plane of the bite surface; and wherein the inner wall upper portion supports a second light source, positioned at a central portion, such that a surface of the second light source through which light is emitted defines a plane that is oriented at a second angle relative to the horizontal plane of the bite surface, the first angle being greater than the second angle.
  • Embodiment 3 The intraoral device according to Embodiment 2, wherein the horizontal plane is a first horizontal plane, wherein the inner wall lower portion supports a third light source, positioned at or adjacent to the first end, such that a surface of the third light source through which light is emitted defines a plane that is oriented at a third angle relative to a second horizontal plane of the bite surface; and wherein the inner wall lower portion supports a fourth light source, positioned at a central portion, such that a surface of the fourth light source through which light is emitted defines a plane that is oriented at a fourth angle relative to the second horizontal plane of the bite surface, the third angle being greater than the fourth angle and the second angle being less than the fourth angle; and wherein the outer wall supports a fifth light source such that a surface of the fifth light source through which light is emitted defines a plane that is oriented at a substantially perpendicular angle relative to the first horizontal plane and the second horizontal plane of the bite surface.
  • Embodiment 4 The intraoral device according to any one of Embodiments 1-3, wherein each light source comprises a resistor; and wherein at least a portion of the resistors of the first light strip and the second light strip disposed on a central portion of the inner wall have a lower resistance than the resistors of the light sources adjacent to distal ends of the inner wall.
  • Embodiment 5 The intraoral device according to any one of Embodiments 1-4, wherein each light source is spaced apart from an adjacent light source by a horizontal distance of more than 3 mm and less than 7 mm.
  • Embodiment 6 The intraoral device according to any one of Embodiments 1-5, further comprising: a timing circuit electrically connected to an initiator device, the timing circuit configured to send a signal after a timer period has elapsed; and an indicator configured to notify a user that a time period has elapsed in response to the signal of the timing circuit.
  • Embodiment 7 The intraoral device according to any one of Embodiments 1-6, wherein each of the first light strip, the second light strip, the third light strip, and the fourth light strip are disposed within the body, and wherein each of the light sources are offset from an outer surface of the body by 1.75 mm to 2.25 mm.
  • Embodiment 8 The intraoral device according to any one of Embodiments 1-7, wherein the first light strip is arranged closer to the bite surface than the second light strip, and wherein the third light strip is arranged closer to the bite surface than the fourth light strip.
  • Embodiment 9 The intraoral device according to any one of Embodiments 1-8, wherein a power output of each light source compared to the power output of the battery defines an intensity -to- wattage ratio no less than 0.8 mW/cm 2 output per mW input to a maximum of 1.0 mW/cm 2 per mW input.
  • Embodiment 10 The intraoral device according to any one of Embodiments 1-9, wherein the battery is a single cell lithium polymer battery having a capacity between 350 mAh to 700 mAh and wherein the battery provides power to the light sources for at least 14 minutes before needing to be charged.
  • Embodiment 11 The intraoral device according to any one of Embodiments 1-10, wherein a forward voltage of each light source is below 3 V and wherein a drive current of each light source is less than 30 mA.
  • Embodiment 12 The intraoral device according to any one of Embodiments 1-11, wherein the bite surface defines at least two openings extending between the upper channel and the lower channel.
  • Embodiment 13 A method of manufacturing an intraoral device, the method comprising: providing a frame, the frame defining an inner wall, an outer wall, and a first bite surface portion extending between a portion of the inner wall and a portion of the outer wall, wherein the inner wall, the outer wall, and the bite surface define an upper channel and a lower channel, the inner wall comprising an inner wall upper portion and an inner wall lower portion, and the outer wall comprising an outer wall upper portion and an outer wall lower portion; coupling a first light strip to the inner wall upper portion; coupling a second light strip to the outer wall upper portion; coupling a third light strip to the inner wall lower portion; coupling a fourth light strip to the outer wall lower portion; each of the first light strip, the second light strip, the third light strip, and the fourth light strip comprising light sources, and each light source being configured to emit light having a wavelength of 441 nm to 459 nm at an intensity of 98 mW/cm 2 to 102 mW/cm 2 ;
  • Embodiment 14 The method according to Embodiment 13, wherein each light source has a height no greater than 0.8 mm and a viewing angle of at least 125 degrees.
  • Embodiment 15 The method according to Embodiment 13 or Embodiment 14, wherein the frame is formed of a first material, and the body is formed of a second material, and wherein the first material is more rigid than the second material.
  • Embodiment 16 The method according to Embodiment 1 , wherein the second material is transparent.
  • Embodiment 17 The method according to any one of Embodiments 13-16, wherein the inner wall upper portion supports a first light source, positioned at or adjacent to a first end, such that a surface of the first light source through which light is emitted defines a plane that is oriented at a first angle relative to a first horizontal plane of the bite surface; wherein the inner wall upper portion supports a second light source, positioned at a central portion, such that a surface of the second light source through which light is emitted defines a plane that is oriented at a second angle relative to the first horizontal plane of the bite surface, the first angle being greater than the second angle; wherein the inner wall lower portion supports a third light source, positioned at or adjacent to the first end, such that a surface of the third light source through which light is emitted defines a plane that is oriented at a third angle relative to a second horizontal plane of the bite surface; and wherein the inner wall lower portion supports a fourth light source, positioned at a central portion, such that a surface of
  • Embodiment 18 An intraoral device, comprising; a body, comprising; an inner wall comprising an inner wall upper portion and an inner wall lower portion, an outer wall comprising an outer wall upper portion and an outer wall lower portion, a bite surface at least partially extending between the inner wall and the outer wall, the inner wall upper portion defining distal ends and a middle portion, the middle portion having an angle relative to the bite surface different from an angle of the distal ends relative to the bite surface; and the inner wall lower portion defining distal ends and a middle portion, the middle portion having an angle relative to the bite surface different from an angle of the distal ends relative to the bite surface; wherein the angle of the middle portion of the inner wall lower portion is different from the angle of the middle portion of the inner wall upper portion; wherein the inner wall, the outer wall, and the bite surface define an upper channel and a lower channel, a first light strip arranged on the inner wall upper portion, a second light strip arranged on the outer wall upper portion, a third light strip arranged on the inner wall lower portion,
  • Embodiment 19 The intraoral device according to Embodiment 18, wherein the angle of the middle portion of the inner wall upper portion is between 140° and 160°; wherein the angle of the middle portion of the inner wall lower portion is between 110° and 130°.
  • Embodiment 20 The intraoral device according to Embodiment 18 or Embodiment 19, wherein a radius of curvature of the first light strip is less than a radius of curvature of the third light strip.
  • Embodiment 21 A method of operating an intraoral device, the method comprising: providing a body, the body including an inner wall comprising an inner wall upper portion and an inner wall lower portion, an outer wall comprising an outer wall upper portion and an outer wall lower portion, a bite surface at least partially extending between the inner wall and the outer wall, wherein the inner wall, the outer wall, and the bite surface define an upper channel and a lower channel, a first light strip arranged on the inner wall upper portion, a second light strip arranged on the outer wall upper portion, a third light strip arranged on the inner wall lower portion, a fourth light strip arranged on the outer wall lower portion, each of the first light strip, the second light strip, the third light strip, and the fourth light strip comprising light sources, each light source being configured to emit light having a wavelength of 441 nm to 459 nm at an intensity of 98 mW/cm 2 to 102 mW/cm 2 , each light source having a height no greater than 0.8 mm, and each light source
  • Embodiment 22 The method according to Embodiment 21, wherein the inner wall upper portion supports a first light source, positioned at or adjacent to a first end, such that a surface of the first light source through which light is emitted defines a plane that is oriented at a first angle relative to the bite surface; and wherein the inner wall upper portion supports a second light source, positioned at a central portion, such that a surface of the second light source through which light is emitted defines a plane that is oriented at a second angle relative to the bite surface, the first angle being greater than the second angle.

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  • Radiology & Medical Imaging (AREA)
  • Business, Economics & Management (AREA)
  • General Business, Economics & Management (AREA)
  • Oral & Maxillofacial Surgery (AREA)
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  • Dental Tools And Instruments Or Auxiliary Dental Instruments (AREA)

Abstract

L'invention concerne un dispositif intrabuccal comprenant un corps comprenant une première bande lumineuse disposée sur une partie supérieure de paroi interne, une deuxième bande lumineuse disposée sur une partie inférieure de paroi interne, une troisième bande lumineuse disposée sur une partie inférieure de paroi interne, et une quatrième bande lumineuse disposée sur une partie inférieure de paroi externe. Chacune de la première bande lumineuse, de la deuxième bande lumineuse, de la troisième bande lumineuse et de la quatrième bande lumineuse comprend des sources de lumière, chacune étant conçue pour émettre de la lumière ayant une longueur d'onde de 441 nm à 459 nm à une intensité de 98 mW/cm2 à 102 mW/cm2. De plus, chaque source de lumière a une hauteur inférieure ou égale à 0,8 mm et un angle de visualisation d'au moins 125 degrés. Le dispositif intrabuccal comprend une batterie supportée sur le corps destinée à alimenter les sources de lumière et un commutateur d'initiation destiné à commander le flux d'électricité de la batterie aux sources de lumière.
PCT/US2024/041542 2023-08-08 2024-08-08 Dispositifs intrabuccaux Pending WO2025035013A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202363518207P 2023-08-08 2023-08-08
US63/518,207 2023-08-08

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WO2025035013A1 true WO2025035013A1 (fr) 2025-02-13

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010098761A1 (fr) * 2009-02-27 2010-09-02 Leslie Cifuentes French Dispositif de blanchiment intra-oral
US20110104631A1 (en) * 2008-08-06 2011-05-05 Levine Jonathan B Methods for effecting oral treatment of teeth or gums
US20210137665A1 (en) * 2018-01-12 2021-05-13 Sunstar Suisse S.A. Light-emitting intraoral device
WO2022026579A2 (fr) * 2020-07-28 2022-02-03 Biolectrics Llc Systèmes et procédés associés à une stimulation électrique intra-orale
US20230076166A1 (en) * 2015-12-22 2023-03-09 Colgate-Palmolive Company Oral Treatment Device

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110104631A1 (en) * 2008-08-06 2011-05-05 Levine Jonathan B Methods for effecting oral treatment of teeth or gums
WO2010098761A1 (fr) * 2009-02-27 2010-09-02 Leslie Cifuentes French Dispositif de blanchiment intra-oral
US20230076166A1 (en) * 2015-12-22 2023-03-09 Colgate-Palmolive Company Oral Treatment Device
US20210137665A1 (en) * 2018-01-12 2021-05-13 Sunstar Suisse S.A. Light-emitting intraoral device
WO2022026579A2 (fr) * 2020-07-28 2022-02-03 Biolectrics Llc Systèmes et procédés associés à une stimulation électrique intra-orale

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