Patent Application: US-201313943651-A

Abstract:
an electro - orthodontic appliance is provided that helps accelerate orthodontic tooth movement through the application of a controlled electrical current to gum and teeth , thus stimulating osteogenesis .

Description:
the disclosure provides a novel electro - orthodontic remodeling device having a special bite plate that contacts lingual and facial teeth surfaces , in addition to occlusal surfaces , and has electrodes thereon for provide current or em fields to the teeth and / or periodontal tissue . the invention can comprise one or more of the following embodiments , in any combination : an electro - orthodontic remodeling device comprising : an intraoral bite plate having a substantially u - shaped surface for contacting an occlusal surface of teeth ; said u - shaped bite plate having an outside edge having upper and lower rims to contact upper and lower facial surfaces of teeth and gums ; said upper and lower rims having anodes and cathodes on tooth and gum contacting surfaces thereof ; an extraoral waterproof housing containing a power source operably coupled to a processor for controlling said voltage source and providing said anodes and cathodes with either : a current of less than 100 μamp at a frequency of less than 100 hz , or a pulsed magnetic field of less than 100 mtesla at 0 - 150 hz ; wherein said u - shaped bite plate reversibly and operably connects to said housing ; wherein said device is held in place during usage by teeth clamping on the bite plate and lacks any head or neck attachment devices . an electro - orthodontic remodeling device comprising : a flexible strip have a first side and a second side , said strip having an adhesive coating on said first side , said adhesive coating covered with a removable protective layer , one or more pair of electrodes on said second side , said electrodes electrically connected to a voltage source and an on / off switch on said strip , said voltage source being able to provide a current of ≦ 100 microamp at ≦ 100 hz to said electrodes or an electromagnetic field of ≦ 100 mtesla at ≦ 150 hz from said electrodes . a completely intra - oral electro - orthodontic device , comprising : an intraoral bite plate allowing for contact with an occlusal surface and at least one of lingual and buccal surfaces of upper and lower teeth and gums , and wherein a surface of said bite plate has two or more electrodes thereon positioned so as to contact said upper and lower tooth and gums when in use ; said intraoral bite plate also having a voltage source operably coupled to a processors for controlling said voltage source ; said voltage source operably coupled to said electrodes ; wherein said processor and voltage source can provide current of less than 100 μamp at 0 - 100 hz to said electrodes or an electromagnetic field of 1 - 100 mtesla at 0 - 150 hz from said electrodes . an electro - orthodontic remodeling device comprising : an intraoral bite plate having a substantially u - shaped surface for contacting an occlusal surface of teeth , said u - shaped bite plate having an outside edge having upper and lower rims to contact an upper and lower facial surfaces of teeth and gums ; said u - shaped bite plate having an inside edge having optional upper and lower rims to contact at least a portion of an upper and lower lingual surfaces of teeth and gums ; said upper and lower rims of said outside and optionally inside edges having anodes and cathodes on a tooth and gum contacting surface thereof ; an extraoral waterproof housing containing a power source operably coupled to a processor for capturing usage data and for providing current of less than 100 μamp at a frequency of less than 100 hz to said anodes and cathodes ; said u - shaped bite reversibly and operably connected to said housing ; wherein said device is held in place during usage by teeth clamping on the bite plate and lacks other head attachment means . an electro - orthodontic remodeling device consisting essentially of an intraoral bite plate having a substantially u - shaped surface for contacting an occlusal surface of teeth , said u - shaped bite plate having an outside edge having upper and lower rims to contact an upper and lower facial surfaces of teeth and gums , and said upper and lower rims having electrodes on a surface thereof ; said u - shaped bite plate having an inside edge having optional upper and lower rims to contact at least a portion of an upper and lower lingual surfaces of teeth and gums , one or both of said upper and lower rims having positive and negative electrodes on a tooth facing surface thereof ; an extraoral waterproof housing containing a charging port operably coupled to a rechargeable battery operably coupled to a processor operably coupled to a data port ; said u shape bite plate reversibly and operably connected to said housing ; said battery and processor providing a current to said electrodes of less than 100 μamp or a magnetic field of less than 100 mtesla at 0 - 150 hz . this device can also be optionally provided with a vibration source , as herein described . an electro - orthodontic device , consisting essentially of an extra - oral voltage source ; an extra - oral processor operably coupled to an extra - oral data port , wherein said processor controls said extraoral voltage source and captures usage frequency and duration ; an extra - oral power source that drives said voltage source and processor ; an intraoral attachment consisting of a bite plate allowing for contact with an occlusal surface and at least one of lingual and buccal surfaces of a patient &# 39 ; s teeth , wherein a patient biting on said bite plate holds said device in place during use , and wherein a surface of said bite plate has one or more electrodes thereon positioned so as to contact a patients tooth and / or gums when in use ; wherein the extraoral voltage source is operably coupled to said pair of electrodes ; wherein said orthodontic device is hermetically sealed and can provide current of less than 100 μamp at 0 - 100 hz to said electrodes or an electromagnetic field of 1 - 100 mtesla at 0 - 150 hz from said electrodes . an electro - orthodontic remodeling device comprising : an intra - oral bite plate having a substantially u - shaped surface for contacting an occlusal surface of teeth , said u - shaped bite plate having an outside edge having upper and lower rims to contact an upper and lower facial surfaces of teeth and gums , and said upper and lower rims having positive and negative electrodes on a tooth contacting surface thereof ; said u - shaped bite plate having an inside edge having optional upper and lower rims to contact at least a portion of an upper and lower lingual surfaces of teeth and gums , said upper and lower rims optionally having positive and negative electrodes on a tooth facing surface thereof ; said extraoral waterproof housing containing a charging port operably coupled to a rechargeable battery operably coupled to a processor operably coupled to a data port ; said electrodes comprising a conductive plastic ; said u shape bite plate reversibly and operably connected to said housing ; said power source and processor providing a current to said electrodes of less than 100 μamp or a magnetic field of less than 100 mtesla at 0 - 150 hz . an electro - orthodontic remodeling device comprising : a transparent aligner fitting over a patient &# 39 ; s teeth and applying pressure to one or more maloccluded teeth so as to remodel said maloccluded teeth ; said aligner having an inner surface that contacts the surface of said patient &# 39 ; s teeth and / or gums ; said inner surface having a pair of electrodes thereon ; said aligner also having an application specific integrated circuit ( asic ) operatively connected to a power source and said electrodes , such that said asic provides a current to said electrodes of less than 100 μamp or a magnetic field of less than 100 mtesla at 0 - 150 hz . the device can also be combined with vibration , preferably at 20 - 40 hz , or 30 hz , and 0 . 1 - 0 . 5n or 0 . 2 - 0 . 25 n . preferably , the device is also smooth and quiet , having a noise level less than 55 db when measured at 6 inches , and being capable of vibrating at a frequency of 20 - 40 hz , with a variance of only 2 hz or less , and a force of 0 . 1 - 0 . 5 newtons , with a variance of +− 0 . 05 n or less . the processor can store usage data and coding sufficient to convert said usage data into daily use , average daily use and average weekly or monthly use , or convert said usage data into a graphic representation of daily use , average daily use and average weekly or monthly use . also provided are methods of orthodontic remodeling , comprising biting the bite plate herein described , or by applying the strip herein described to teeth or a positioner or aligner , and activating said device for at least 10 minutes at least once a day , preferably 20 minutes . fig1 is a cross section of the electro - orthodontic driver 510 and half of a bite plate 610 . the electro - orthodontic driver 510 has a housing 505 containing all components , except the stem 580 , which protrudes therefrom . preferably , housing 505 is water resistant or even more preferred it is waterproof or hermetically sealed . a voltage and / or em source 530 is shown schematically as a simple box . the housing also contains power source 540 , preferably a rechargeable battery , and can have an optional charging port ( either not shown or can be usb port 560 ). processor 550 captures usage data , and may also control the voltage source 530 . data is transmitted to a server or computer or the internet via data port or usb 560 , which can also provide for battery recharging . connections or wires 570 are shown in simple form only and not intended to convey actual wiring connections , as are on / off switches 520 . the voltage source 530 may be the same as battery 540 in some embodiments , but this is not necessarily the case , and in many cases a separate component is needed to interface between the battery and the electrodes , e . g ., step up or step down converters , dc to dc converter , dc to ac converter , rectifiers , inverters , and the like . stem 580 is shown here with depressions 590 , which can circumnavigate the stem in one embodiment , but many variations of snap fitting and other connectors are possible . in addition , the stem can be on the bite plate , and the socket can be in the housing . it is preferred that the bite plate be detachable , as this allows the user to change bite plates , which may become worn , or which may no longer fit as treatment progresses . bite plate 610 has a hard inner core that forms the socket 605 and can be any suitable shape . an exemplary circle spring 690 fits into depressions 590 on stem 580 and the bite plate thus removably snap fits onto the extraoral driver 510 , but any reversible attachment means or snap - fit means can be used . the bite plate has the labial , lingual edges and occlusal surfaces . thus , 620 are the flat surfaces that contacts occlusal surfaces of the teeth , which fit into the bite plate at the heavy arrows . anterior vertical surfaces 630 and 640 contact the facial tooth surfaces , while posterior vertical surfaces 650 and 660 contact the lingual tooth surfaces . the core partially inside the lingual phalanges 650 and 660 is shown , but this element can be optional depending on the flexibility of the coating , so if less flexible material is used , the core may not be needed , as shown with facial phalanges 630 and 640 , although using a core that fits into the phalanges may simplify manufacturing , as it provides an assembly surface . by “ phalange ” what is meant herein is the vertical edges or rims on the u - shaped bite plate . the various teeth contacting surfaces of the bite plate can be shaped to closely follow a patient &# 39 ; s teeth , as with an aligner , or can be simplified and fit a wide range of dentition and allow use over traditional braces . preferably , these edges or coating is made of a resilient material of durometer at least 30 - 80 shore a , most preferred is a biocompatible or medical grade clear silicone of about 40 shore a . the surfaces of the bite plate have electrodes 531 which can be placed on the core or on the coating if present , and can optionally be covered with a film of conductive resin . electrodes 531 can be any suitable distance apart , but are preferably from 2 - 10 mm apart , ˜ 7 mm , and either electrode can be the anode or cathode . in this simple figure , the electrodes are shown connecting to the stem on the sides of the stem , and the requisite connectors 695 shown as small boxes , and the interior wiring inside the stem is not shown . another configuration is shown in fig2 , wherein the electrodes are shown terminated with a connector inside a stem 700 with depression 710 that fits into a socket 720 on the housing having protrusions ( not shown ) to snap fit into depressions 710 . in this embodiment , the electrodes only contact the facial surface of the teeth and / or gum , and there are no electrodes on the lingual side , and this may be preferred as the tongue is expected have increased sensitivity to current . however , there are still 4 pairs of electrodes , thus shortening the distance the current needs to travel and reducing losses . alternatively , a single wire can bifurcate , covering both sides of the oral cavity . electrode configuration and placement can thus vary . the processor 550 can be configured to provide a wide range of functionalities , including one or more of 1 ) recording usage data , 2 ) transmitting usage data wirelessly or via usb port or other connections , 3 ) wirelessly transmits data to a smartphone application that reminds the user when to use same and / or reports usage to a parent or dental professional , 4 ) tuning the frequency and voltage over an acceptable efficacious range , and 5 ) when combined with a vibrator can allow selection of vibration frequency and force over an acceptable efficacious range . fig3 shows a peel and stick electrode strip that can be applied to existing aligners , positioners , bite plates , and the like , thus speeding their remodeling effect . this embodiment is a simple , flexible strip 400 having an on / off switch 405 connected to electrodes 403 , battery 409 and processor or asic 410 . preferable , the strip is flexible enough to allow it to be bent to use with various sized aligners , e . g ., 30 - 70 shore a and has a smooth lingual surface with a very low profile , and a flat back surface , with adhesive layer 411 , and a removable protective layer over the adhesive layer ( not shown , but well known in the art ). in the embodiment shown , the on / off switch 405 lies on the occlusal face , such that it can be activated by biting with a molar , but it could also be on a lingual or facial surface and activated with the finger or tongue . furthermore , the adhesive is shown on the surface opposite the electrodes , but this is optional , and the strip can be configured appropriately for its intended use . an application - specific integrated circuit 410 can be designed to drive the device , allowing it to be completely intraoral and lacking any extra - oral components . batteries or charged capacitors can be selected to allow several hours of use , and if wirelessly rechargeable batteries are employed , the device should last through an entire treatment period . alternatively , the device can be cost effective enough to allow disposal when the batteries wear out . in use , the protective strip is removed , and the electrode strip applied to retainer 10 or other device or even applied directly to the teeth . the attachment can vary . if thin enough , the strip can fit inside the retainer and thus be pushed directly against the teeth . however , it may be preferred to apply the strip to the outer surface of the retainer , such that the electrodes come into contact with the gums , above or below the retainer , and in such embodiment , the adhesive would be on the same side of the electrodes . we anticipate that such a micropulse strip can be made inexpensively enough that the patient can purchase a dozen or so , to be used with the various aligners made throughout the course of his or her treatment . once attached , the patient can activate the switch with the tongue , finger or tooth , and apply current to the treatment area for the desired time period , e . g ., every few days , daily , or more frequently . in a variation on this theme , it is possible that the strip can be attached magnetically , rather than with adhesive , and thus be removed when not in use . other attachments means are also possible . fig4 shows alternative custom embodiment , wherein the micro - pulse driver and electrodes are integrated with the aligner during manufacture . aligner 10 includes an asic 11 , charged capacitor 12 , on / off button 13 positioned to be activated by biting the molars , and electrodes 14 and 15 . these electrodes 14 and 15 may be on an inner lingual surface of the aligner ( for aesthetics ) where they can contact the lingual surfaces of the teeth and / or gums , but the remaining components can be either on an inner lingual surface or an outer lingual surface as desired for low bulk , aesthetics and ease of manufacturing ( they are shown on the inner lingual surface herein ). the electrodes can also be on a facial surface , particularly where the electrode materials are translucent or do not otherwise interfere with aesthetics . the on / off switch in such embodiment is optional , thus reducing bulk , where the asic is designed to provide multiple pulses on e . g ., an hourly or bihourly basis . in such embodiment , the micro - pulses are applied whenever the patient utilizes the device . when an on / off switch is included , the aligner provides micro - pulses at the patient &# 39 ; s discretion . fig5 shows the exterior shape of a bite plate that can include the electrodes as described herein . bite plate ( 1000 ) has a generally u - shaped base ( 1001 ) that contacts occlusal surfaces of the teeth , the base having front and back edges , one or both edges having a rim to contact the facial and lingual surfaces of teeth and / or gums . thus , upper lingual rim ( 1002 ), lower lingual rim ( 1003 ), upper facial rim ( 1005 ) and lower facial rim ( 1006 ) are shown . in this instance , the lingual rims contact only the incisors and / or canines , but not the molars . however , the rims can be varied in length to contact all , or a portion , of the teeth . it is preferred that at least one rim contact each tooth , except for badly maloccluded teeth , which by definition are out of alignment . although the facial rims can contact all teeth , many children lack wisdom teeth , and there is limited space and often distal appliances further reducing space . thus , the facial rim can taper off distally , as shown . the lingual rim need not contact more than the incisors , since the vibration is already effectively transmitted via the facial rims , and the lingual rims are for device placement and stability in use . herbst accommodating bite plates can also be used , with facial rims that do not touch the premolars or molars , as described in 61 / 824 , 798 , filed may 17 , 2013 . also shown is the stem ( 1008 ), which is the portion of the bite plate ( 1000 ) that mates with a corresponding socket in the extra - oral housing ( not shown here ), which contains the power source , vibratory source , processor for controlling the mechanism and providing compliance features . in more detail , a cylindrical shaft 1009 is shown , having a groove into which a jump ring ( not shown ) fits , and mates with a corresponding depression in the socket . optional flare ( 1112 ) is also shown , and is configured to provide an appropriate surface so that the user can push the stem into the socket . fig6 a - d show the dimensions of the bite plate inner core and connector . preferably , the connector operably connects ( snap fits ) into the socket found on the acceledent ® and acceledent ® aura . using similar connectors allows the bite plates to be interchangeable , and also allows any bite plate inventory to be used even when the driver unit model is updated . thus , these sizes are valuable for interchangeability of parts . in fig6 c , the minimum for interchangeable parts requires the cylindrical post 1009 of about 10 . 25 mm in length by about 6 . 35 mm in diameter ( tolerance in the diagram noted to be + 0 . 03 , − 0 . 1 ) mm with a groove at about 4 mm from the attached end of the post . the connector has a flared base ( flare not shown herein because made from the over - coating material , but can be seen in fig5 etc .) with a flat surface opposite the bite plate , from which protrudes a centrally positioned cylindrical post that is 6 - 7 ( 6 . 35 + 0 . 03 , − 0 . 1 ) mm in diameter , 10 - 11 ( 10 . 25 ) mm in length , and having a groove circumventing the post about half way ( 4 mm from flat surface ), the groove having a width of 1 . 65 mm . the flared portion is dumbbell in cross section and provides a suitable surface for the thumb and finger to push the bite plate connector into the socket on the driver . as shown in fig6 b , the bottom of the post also has a pair of ˜ 1 . 4 × 3 mm pins ( optional ) projecting 180 ° from each other ( in the same plane as the occlusal contacting base of the bite plate ). these pins have a total spread of 11 . 30 mm at the topmost edge , but flare 10 ° on each side ( 20 ° total ) to reach the flat surface of the base . the pins are 1 . 63 mm thick ( as shown in fig6 d ), and 2 . 75 mm high ( as shown in fig6 b ). the base of the connector also preferably has a pair of recessions 1114 , which are ˜ 1 . 5 mm wide × 3 mm long × 2 mm deep ( 1 . 58 × 3 . 27 × 2 . 5 mm ) on the flat surface 1113 thereof for engaging clips from the driver , the recessions 1114 being about 16 - 17 mm apart ( 22 . 89 mm in spread ), and positioned right below the pins . the recessions 1114 can be omitted however , if the base is either not flared or is otherwise smaller , such that the remaining post and pins still fit , leaving the engaging clips on the driver free . these dimensions are approximate , and exact dimensions are provided on fig6 a - d . tolerances are as appropriate for the material , while still providing a reversibly locking fit . 60 / 906 , 807 , us20080227046 , us20080227047 , us20090051312 , us20100055634 , 61 / 624 , 242 , pct / us13 / 36289 , us20110136070 , us20120040300 , us20130059263 and us201300322018 , ser . no . 13 / 850 , 151 , 61 / 673 , 236 , 61 / 769 , 507 , 61 / 701 , 532 , 61 / 824 , 798 . kau , et al ., the clinical evaluation of a novel cyclical force generating device in orthodontics , orthodontic practice 1 ( 1 ) ( 2010 ). davidovitch z , et al ., electric currents , bone remodeling , and orthodontic tooth movement . ii . increase in rate of tooth movement and periodontal cyclic nucleotide levels by combined force and electric current , am j orthod . 77 ( 1 ): 33 - 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