JP2019013463A - Improved orthodontic promoter - Google Patents

Abstract

An orthodontic promoter that effectively transmits a vibration force to a tooth is provided. An improved vibratory orthodontic device 10 has an intraoral bite plate 20 that is inserted into a patient's mouth. The bite plate is connected to the extraoral vibration source 30. The device is held by the patient's jaw 40 pressing the bite plate and secures it between the dental arches. There, the motor speed is controlled by a capacitive sensor, so that there are no moving parts required for the use of the encoder. This improved device also utilizes a tungsten offset weight to reduce the size by more than 50% and still produce the required force. Thus, the device is miniaturized, lighter and more robust. [Selection] Figure 1A

Description

RELATED TECHNOLOGY This application claims priority to US provisional application serial number 60 / 906,807 filed March 14, 2007, both filed on July 5, 2007. Serial continuations of serial number 11 / 773,849 (published as US20080227046) (pending) and US application serial number 11 / 773,858 (published as US20080227047), each of which is in its entirety Incorporated herein by reference. This application also includes US application serial number 12 / 615,049 (US9028250) filed November 9, 2009, US application serial number 13 / 609,346 filed September 11, 2012 (ongoing). US application serial number 13 / 684,220 (US8500446) filed on November 22, 2012 and 13 / 973,865 (pending) filed on August 22, 2013 . Each of these applications is incorporated herein by reference in its entirety for all purposes.

  The present invention relates to an improved vibratory device used to facilitate orthodontic remodeling action.

  Malocclusion is a misplaced tooth or an inappropriate relationship between the teeth of two dental arches. This term was devised by Edward Angle, the “father of modern orthodontics”, as a derivative of occlusion, which refers to the way of meshing teeth facing each other. His classification of malocclusion based on angle is based on the relative position of the maxillary first molar. Depending on the angle, the mesial buccal cusp of the upper first molar must align with the buccal groove of the first molar of the mandible. The teeth must all coincide on the occlusal line, which is a smooth curve that passes through the central fossa and upper cuspid band and through the buccal cusp and incisal edge of the lower jaw. Any deformation resulting from it will also result in malocclusion.

  There are three classes of malocclusions, I, II and III. Class II is further classified into three subtypes.

  Class I: Neutral occlusion The occlusal molar relationship is normal here, or as described for the maxillary first molar, but the other teeth are spaced, dense, the occurrence of upper or lower teeth, etc. Have problems.

  Class II: Centrifugal buccal occlusion (jaw retraction, overjet) In this situation, the upper molar is not placed in the mesial buccal groove but is placed in front of it. Typically, the mesial buccal cusp is placed between the first lower molar and the second premolar. There are two subtypes.

  Class II Category 1: The relationship of molars is similar to Class II, with the front teeth protruding.

  Class II Category 2: The molar relationship is class II, but the central incisor is inclined lingually and the side incisor appears to overlap the central incisor.

  Class III: mesial occlusion (prognathic jaw, minus overjet) In this case, the upper molar is not placed in the groove on the mesial cheek side but is placed behind it. The mesial buccal cusp of the upper first molar is located behind the mesial buccal groove of the lower first molar. This malocclusion is usually seen when the anterior tooth on the lingual side protrudes from the upper anterior tooth. In such cases, patients often have either large or short maxillary bones.

  Orthodontics, formerly orthodontic (from the Greek orthos “straight or proper or complete” and oddus “tooth”), research on malocclusions (improper or dysfunctional occlusions) and It is a specialized field of treatment, and malocclusion can be an uneven tooth, an unbalanced facial skeletal relationship, or both. Orthodontics treats malocclusions by moving the position of the teeth by managing and correcting bone remodeling and facial growth.

  Bone is reconstructed by the associated activities of three cell types: osteoblasts, bone cells and osteoclasts. Osteoblasts are cells that form the extracellular matrix of bone and are responsible for its petrification. Osteoblasts also have endocrine activity due to the secretion of osteocalcin, which regulates fat and energy metabolism. These cells also control osteoclast differentiation and activity. Bone cells are osteoblasts that are incorporated into the bone matrix and have extensive dendrites through cells that communicate with other bone fat and osteoblasts. The mechanical loading action is sensitized by this dendrite and converted into a biological response involved in the management of osteoblast and osteoclast function. Bone cells also have endocrine activity by releasing fibroblast growth factor 23, which involves phosphate secretion in the kidney. Differentiation of osteoclast mononuclear progenitors to grow multinucleated osteoclasts is governed by colony-stimulating factor and NF-κB ligand receptor activator macrophages, stromal cells or bone in bone growth Represented by osteoblasts as well as bone cells. Integrated endo-type and paracrine control of osteoblasts, bone cells, and osteoclasts maintains bone quality and remodels within the bone, including during tooth movement induced by orthodontics And is important for managing the modeling process.

  The process of orthodontic bone remodeling is conventionally accomplished by utilizing stationary mechanical forces to induce bone remodeling, thereby allowing the teeth to move. I came. This widely accepted procedure for treating malocclusion takes on average approximately 24 months to complete. In this approach, the orthodontic brace is composed of an arched wire that continuously applies a stationary force and meshes with a bracket attached to each tooth. Braces can be used for several different classes of clinical malocclusions, including anterior occlusion, overbite, cross bite, open bite and bent teeth for both aesthetic and functional / structural reasons. Used to treat.

  Orthodontic treatment is complicated because it is uncomfortable and / or painful for the patient, and orthodontic appliances are perceived as detracting from aesthetics, all of which are repulsive to use. It has become. In addition, the average treatment time of 24 months is very long and even reduces utilization and compliance, which may include long-term oral health degradation. In fact, some estimate that less than half of patients who would benefit from such treatment would choose to continue with orthodontics.

  Kesling introduced a tooth positioning tool in 1945 as a way to further refine the final stage of orthodontic finishing after band removal. The positioner is an integral, bendable, rubber instrument made on a hardened wax that has been made ideal for the patient, and its basic treatment was perfect, but still a little improved. It was desired. Kesling also predicted that certain primary tooth movements could also be achieved using a series of positioners made from tooth movements that occur sequentially on the setup as treatment progresses. However, this idea was not put into practice until the rise of 3D scanning and computer modeling in 1997.

  A removable transparent instrument, such as the Invisalign® system, has been introduced to treat malocclusions, and the device is transparent, which can greatly improve the aesthetics. However, since such devices can be removed, compliance can be a problem, and not using them can delay the overall treatment time.

  As one mode of treatment, aligners also limit the class of clinical malocclusion they can deal with. In the past, aligners have been unable to easily rotate or push teeth because they have not been able to properly direct forces in all directions. Recognizing these limitations, Align Technologies recently developed Invisalign®, a transparent wear device that can provide a specific surface that can be in close contact with the tooth and exert a force in any desired direction. ) In combination with a clear aligner. A custom mold is created with a pocket in it to place a force application device using a 3D model of the patient, and its placement and shape is determined using modeling software appropriate to the owner Is done. An associated force application device is created, fitted into the mold, an adhesive is applied to the application device, and the mold is applied to the teeth. This makes it possible to place the transparent mounting device accurately and quickly, which is then attached using photocuring. The force applicators are also transparent and have some aesthetic benefits as they are not so noticeable from a certain distance.

  In addition to static forces, periodic forces may be used for remodeling orthodontics. Kopher and Mao assess 5N peak magnitude periodic force at 1 Hz in rabbits, Peptan and Mao assess 1N periodic force at 8 Hz in rabbits, and Vij and Mao 4 Hz in rats. A periodic force of 300 mN was evaluated. Taken together, data from these three studies showed that periodic forces between 1 and 8 Hz with forces in the range of 0.3 N to 5 N enhance bone remodeling. The ratio depends on various methodologies, but for vibration forces, an increase of 2.5 times was common.

  Early Mao studies provided criteria for both the effectiveness and safety of using vibration in humans to help orthodontic tooth movement. However, Mao's early experiments have been conducted on a closed model of a rabbit cranial suture, and no device has been constructed to date that can be used on human teeth. Thus, although suggestive, this work needs to be repeated on human teeth to prove its effectiveness. However, there was no such device available.

  OrthoAccel® Technologies Inc. Invented the first commercially successful dental vibration device designed to apply periodic forces to the dentition with the aim of facilitating remodeling as described in US20080027046. Both intraoral or extraoral embodiments are described in US20080227046, each having a processor for capturing and transmitting patient usage information. The bite plate is specifically designed to contact the occlusal surface of the dentition, as well as the lingual and / or facial surfaces, so it is more effective than any prior art device to transmit vibration forces to the teeth Met.

  In addition, this device has been tested in human clinical trials and has shown to accelerate orthodontic remodeling by as much as 50%. It is therefore a major breakthrough in orthodontic technology (Kau 2010). Ultimately, this device does not have the bulky and heavy headgear of the prior art devices, it is capable of a messy and hands-free operation, and has optimized forces and frequencies for orthodontic remodeling. This has also been shown to increase its comfort level and compliance, and patients liked the device after the motor was redesigned quieter and smoother, especially as described in US20130005634 (see below). It is reported that. In fact, this device has been marketed as AccelDent® in several countries and has achieved remarkable commercial success since its recent introduction. AcceleDent® is a representative example of the first successful clinical procedure to promote orthodontic tooth movement by modulating bone ecology in a non-invasive and non-drug manner .

  However, further improvements in the above devices are always beneficial and the present application addresses some of such improvements.

  In one aspect, the orthodontic appliance includes an extraoral vibration source and a contact surface with the in-mouth dentition in the form of a bite plate or platform. The contact surface of the device couples an extra-oral vibration source and an intra-oral mounting device.

  In another aspect, the orthodontic appliance includes an intraoral vibration source and a bite plate or platform that contacts the dentition.

  Furthermore, the bite plate can contact the teeth at any point or at all points. The bite plate can be in contact with the occlusal surface, preferably the bite plate is in contact with the lingual or facial (or bilateral) surface of the tooth, but for more complex clinical abnormalities In some cases, a plate is designed.

  The processor can control out-of-mouth or in-mouth vibration sources, sample and balance forces. The processor executes software that can be programmed to capture frequency of use and duration and change force, frequency, waveform, number of amplitudes, duration or any other operating parameter. The processor can communicate usage frequency and duration to the remote computer via some type of wired or wireless communication method. The processor can communicate with the remote computer via the Internet, via a smartphone, or simply via another device (eg, Bluetooth, wireless LAN, etc.).

  The processor can communicate dynamically with the user to provide input regarding the use of the device, especially regarding the bite plate or platform being chewed too tightly or not biting sufficiently. Based on the sensing of humidity or temperature, or sensing of the mineral content of saliva, a mechanism for measuring proper use, or other similar mechanism can be provided, and similarly based on such control parameters Feedback may be provided. To do this accurately, pressure sensing techniques such as resistive strain gauges, capacitive or piezoelectric elements are required.

  Preferably, a custom or semi-customized application specific integrated circuit (ASIC) is designed to drive the device, in particular it is preferably a fully oral device. An ASIC can include an entire microprocessor and memory blocks including ROM, RAM, EEPROM, flash, and other large building blocks. Such an ASIC is often referred to as a SoC (system on chip). A hardware description language (HDL) such as Verilog or VHDL can be used to describe the function of the ASIC. Field programmable gate arrays (FPGAs) are another option for driving devices. Programmable logic blocks and programmable interconnects allow the same FPGA to be used in many different applications. For smaller designs and / or lower production volumes, FPGAs may be more cost effective to manufacture than ASIC designs.

  Another option is to utilize a built ASIC design (also referred to as “Platform ASIC Design”). This is due to cell-based ASICs thanks to a pre-defined metal layer (which reduces manufacturing time) and pre-characterization of what is on silicon (which reduces design cycle time). This is because both the manufacturing cycle time and the design cycle time are shortened. Design differentiation and customization is accomplished by creating a custom-made metal layer that creates a custom-made connection between predefined lower-layer logic elements. “Builded ASIC” technology is understood to bridge the gap between field programmable gate arrays and “standard cell” ASIC designs. Since only a few chip layers need to be custom manufactured, the “built ASIC” design is much more than the “standard cell” or “full custom” chip that requires manufacturing a full mask set for all designs Has only a small extraordinary expenditure.

  Important for compliance of use is that the device is comfortable and not unpleasant to use. Early models have variable speed and force that slows down when the patient exerts a greater force on the bite plate, and these irregular vibrations cause some irritation and reduce compliance, Is a problem that could not be predicted from any prior art vibratory apparatus. The device was therefore redesigned to operate more smoothly (and quieter).

  In particular, a certain safe and effective vibration method has been developed that includes an encoder operably connected to a processor having software that counts the time between the first encoder event and the second encoder event. A vibration orthodontic remodeling device comprising: a vibration motor, comparing the time with a target frequency; an intraoral bite plate; and an extraoral signal source utilizing the method. With a single frequency between 20 and 40 Hz with variation (eg, frequency varies by ± 2 Hz from the desired frequency) and when the bite plate is bitten by the patient and the device is activated Maintain the target frequency so that it oscillates with a single force between 0.1 and 0.5 N with a variation of ± 0.05 N (eg, variation is ≦ 0.05 N). Optionally adjusting the motor speed by pulse width modulation to increase or decrease the motor speed. Redesigned software and mechanisms allow for smoother vibration, improve compliance, and further improve the average remodeling rate observed in clinical trials.

  Another way to maintain a constant safe and effective orthodontic force and frequency is to provide a processor for controlling the offset weight vibration motor, and a battery for supplying power to the processor and the motor. The processor is coupled to an acceleration sensor or encoder on the motor, the speed of the motor is measured by the acceleration sensor or encoder, and the drive voltage of the motor is limited by pulse width modulation Adjusting the speed of the motor with a dedicated voltage regulator, wherein the orthodontic remodeling device comprises an intraoral bite plate and an extraoral vibration source, and uses the method of steps a to d. The straightening remodeling device has a single frequency of 20-40 Hz with a variation of only 2 Hz and Adjusting when the device is bitten by the patient and the device is actuated, with a variation of ± 0.05 N and with a single force of 0.1-0.5 N .

  The encoder design described above, however, has moving parts that contribute to size and weight, and provide additional points of failure for the device. This design is therefore further updated herein. In new designs, motor speed management is achieved with no moving parts, resulting in smaller components. Therefore, the size and weight can be further reduced.

  New motor control methods utilize pin headers located somewhere on the circuit board or equivalent such that the header is 0.01-5 mm from the motor. These pin headers exhibit a small electrostatic (ES) field that varies as the motor moves relative to the pins. A solid state sensor operably connected to the pin header can measure such fluctuations, thereby determining how fast the motor is rotating and otherwise moving Can do. Software similar to that described for other applications then adjusts the motor speed to achieve a constant speed even under vibration forces.

  Another option is to use an accelerometer, in which case the MEMS piezoelectric element forms a bridge and can detect movement. Such devices are commercially available from, for example, STMicroelectronics or Freescale (currently NXP Semiconductors). Another option is to use a gyroscope in another way to do that, but this is a more costly option at this time.

  A non-rechargeable or rechargeable battery can drive the vibration source, in which case the rechargeable battery can be any, including, for example, a USB port, an RS-232 port, a wall-mounted DC converter or a FireWire port. It is charged using power from a variety of power sources. Alternatively, the device can be plugged into any wall outlet.

  Vibration is most commonly provided via a motor that rotates a shaft with an unbalanced or eccentric weight (offset motor), or via a piezoelectric device, but utilizes any other vibration means You can also Known methods of generating vibration include motors and camshafts, motors and linkages, motor racks and pinions, motors and drive belts, and similar mechanical methods. However, solenoid vibrators, linear coil vibrators, linear resonance actuators, voice coil actuators and the like can also be used. Some of the existing commercial vibration motors are long-life brushless (BLDC) vibration motors, coin (pancake) vibration motors, capsule vibration motors, pager motors, PCB-mounted vibration motors, and coreless DC motors. An ultrasonic motor is included.

  An ideal vibration source is that it is quiet and can be combined with a feedback mechanism to precisely control vibration speed and force. Furthermore, it is small and has an excellent operating life at a cost effective price.

As shown in the table below, a number of very small vibration motors are available, but because of their small size, piezoelectric motors are preferred, and motors with offset weights are low because of their low cost and availability. preferable. Particularly preferred are substantially planar motors and the vibrations are substantially parallel to the substrate (eg, US 5554971, US 5780958, US20090224616, US20080129130, US20070103016, WO0178217, each incorporated herein by reference in its entirety).

  The vibration may be reciprocal vibration, random, directivity, circular, or the like. Vibrators are described in the patent literature (and are commercially available as seen above). For example, US20070299372, US20070255188, US20070208284, US20070179414, US20070161931, US20070161461, US20060287620, each incorporated by reference, describes various vibration motors.

  In particular, the battery may drive the vibration source for the embodiment in the mouth. Small coin batteries, alkali or lithium are preferred due to their small size, but hydrogen batteries are also related in terms of their shelf life, power and power density, especially because of the size reduction and cost reduction with further technology development. It may be preferable. Nickel metal hydrogen batteries are currently preferred.

  In certain embodiments, batteries that can be charged wirelessly are preferred for longer product lifetimes (eg, US20090051312, US7511454), while in other embodiments, low-cost intended for use by a single patient Devices are also being made. It is known in the art to select an appropriate power / motor combination to provide an orthodontic vibrator that vibrates within a frequency and power range suitable for orthodontic remodeling.

  Any commercially available on / off switch can be used. Particularly preferred for intraoral devices are on / off switches with push-down actuators (push buttons, rockers or membrane buttons).

  With every lease, rental or treatment use or any other changeable utilization system as well as a complete buying system, it is possible to provide an extraoral vibration source or device to the patient at a low cost. The system can provide diagnostic information to the service provider. The system also supports recycling of the extraoral vibration source, but the bite plate is intended to be a component used by one patient.

  In another aspect, the device delivers a non-stationary force to change dental tissue, including the jaw, mandible or maxilla. The jaws are subjected to a sustained non-stationary force (e.g., vibration) that is then delivered to the tooth component, which remodels the mandible, maxilla or jaw tissue. The device can be used, among other types, for maxillofacial applications, as well as for trauma such as TMJ (temporomandibular joint), treatment procedures for Rufau fracture segments, teeth and other dental implants.

  In other embodiments, through the promotion of bone remodeling achieved by delivering non-stationary forces, it induces tooth movement, resulting in malocclusions, craniofacial abnormalities, bone defects and dentofacial deformation. Treating, reducing patient pain and discomfort, and improving tissue integrity over time will result in preventing recurrence after orthodontic treatment.

  These methods and devices are specific to establishing the present invention as an element of data capture, patient compliance analysis and usage behavior, and clinical clinic workflows to increase efficiency and productivity. Including mechanism.

  System advantages may include one or more of the following. The system improves the conventional orthodontic treatment process and speeds up the application of non-stationary forces. According to one embodiment of the system, non-stationary forces are utilized to facilitate the skull remodeling task in conjunction with orthodontic treatment. The system can be used to treat all forms and classes of tooth malocclusion, skull abnormalities, bone defects, or odontofacial deformations, and bone remodeling tasks play a physiological role serve. The system can be used exclusively on the upper jaw, exclusively on the lower jaw, or in a double dental arch fashion (both upper and lower jaw simultaneously). In addition, the system can be used to treat the entire dentition, treat cases that exhibit some combination of natural or unnatural tooth loss, and remodel bones of edentulous patients. Patients of any age and patients with any medical profile can be treated. The system may be used by patients who are receiving some type of medication.

  This system allows orthodontic treatment and tooth movement to be considered in the context of a wider range of bone remodeling. The step that limits the degree of progression of orthodontic tooth movement is bone formation. Dynamic loading (periodic forces) leads to greater bone formation or bone growth / bone remodeling than stationary forces. Tooth movement is accomplished by remodeling the surrounding alveolar skull bone. Bone remodeling involves several steps. Initially, effective bone resorption occurs (osteoclast activity), which takes 2 to 3 weeks. The reversal from effective resorption to effective formation (osteoblast activity) then occurs. Finally, bone formation fills the cavity in 3 to 4 months. Osteoclast activity is typically 5 to 6 times faster than osteoblast activity fills it, clearing the path for teeth to move. Therefore, in order to increase the speed of movement, it is necessary to increase the speed of bone formation (bone formation).

  Certain dynamic load patterns (eg, higher frequency and stationary period insertion) greatly improve bone formation compared to basic dynamic loads, such as a 1 Hz sine wave. Inserting a quiescent period is known to be particularly effective because it can cause bone tissue to regain mechanical sensitivity. A decaying return point is achieved within each load session. Therefore, the intermittent load action and the load reduction action by the periodic force can significantly increase the progress of bone formation.

  This system allows for an efficient and even faster treatment period, which involves rapidly changing the force on the teeth. This is done without the need to introduce a piezoelectric current to the mechanically stressed bone. Patient compliance is greatly improved by monitoring usage with a computer. The outcome of treatment depends directly on how strictly the patient follows the instructions of the healthcare professional. The system can be worn for a predetermined period of time, for example approximately 20 minutes or more per day, or any other suitable period, so that the patient wears the device for a reasonable wearing time at home. Can do.

  Healthcare professionals, patients or parents / guardians can infer patient compliance and usage patterns that occur during appointments. Confirmed compliances and usage are stored in electronic means and are available for medical personnel to search, including searching over the Internet via a smartphone / smart device, or any other communication medium. Healthcare professionals may download compliance information directly into readily available customary software packages on the market.

  The system supports a business model that allows non-disposable components of orthodontic treatment to be changed and that is proportional in cost to treatment duration. The device can be disposable or non-disposable. The device may be leased, rented or purchased directly or through an orthodontist or a third party based on the treatment for the patient. The proposed system also increases the throughput of orthodontic cases and accordingly increases the efficiency of the clinic.

  More particularly, the present invention is an orthodontic remodeling device comprising an oral bite plate having a generally U-shaped surface that contacts the occlusal surface of the tooth, wherein the U-shaped bite plate comprises teeth and An outer edge having upper and lower edges in contact with the upper and lower facial surfaces of the gums, the U-shaped bite plate at least of the upper and lower lingual surfaces of the teeth and gums It has an inner edge with optional upper and lower edges that contact the part. There is also a waterproof enclosure outside the mouth that houses a rechargeable battery operably coupled to a vibrator (actuator) operably coupled to a processor for capturing usage data. Operately coupled to the data and charging port for transmitting and charging the battery. The housing can also have an access hatch in it to contact the data and charging port, but may not have the battery or processor. A U-shaped tool is reversibly and operatively connected to the housing, the device is held in place during use by pressing teeth against the tool plate, and other head mounting means are do not have. This feature is particularly important for compliance, as both children and adults generally heal headgear.

  In another embodiment, the device is an oral bite plate having a generally U-shaped surface that contacts the occlusal surface of the teeth, and upper and lower surfaces that contact the upper and lower facial surfaces of the teeth and gums. Operable on the USB port and an oral bite plate having an outer edge with edges and an inner edge with upper and lower edges that contact at least a portion of the upper and lower lingual surfaces of the teeth and gums An external waterproof housing containing a rechargeable battery operably coupled to a vibrator (or actuator) operably coupled to a processor coupled to the access port for contacting the USB port Has a hatch in it but does not contact the battery or processor, the access hatch is connected to the housing, and the battery and / or access hatch uses a specific tool. An open mouth waterproof housing that can only be contacted, the U-shaped bite plate reversibly and operatively connected to the housing, and the orthodontic remodeling device is measured at 6 inches With a noise level of less than 55 dB, a frequency of 20-40 Hz with only a 2 Hz variation, and a variation of ± 0.05 N, 0.1-0.5 Newton It can be vibrated with force or similar force, and the device is held in place during use by pressing teeth against the bite plate and has no other head mounting means.

  In yet another embodiment, the device is an oral bite plate having a generally U-shaped surface that contacts the occlusal surface of the tooth, and upper and lower surfaces that contact the upper and lower facial surfaces of the teeth and gums. An oral bite plate having an outer edge having an edge and an inner edge having optional upper and lower edges that contact at least a portion of the upper and lower lingual surfaces of the teeth and gums; and data A mouthwatering waterproof housing containing a charging port operably coupled to a rechargeable battery operably coupled to a vibrator (or actuator) operably coupled to a processor operably coupled to the port The U-shaped bite plate is reversibly and operatively connected to the housing, and the orthodontic remodeling device is 55 when measured at 6 inches. With a noise level below B, with a frequency of 20-40 Hz with only 2 Hz variation and with a variation of ± 0.05 N, with a force of 0.1-0.5 Newton, Or it is possible to vibrate with the same force.

  In another embodiment, the orthodontic device includes an extra-oral vibration source (or actuator), an extra-oral processor that controls the vibration source, a power source that drives the vibration source, the occlusal surface of the patient's teeth, and a tongue. A mouthpiece configured with a bite plate that enables contact with at least one of the lateral and buccal surfaces, and a patient biting the bite plate defines the device during use And the orthodontic device is hermetically sealed and can vibrate at a frequency of 0.1 to 400 Hz.

  In another embodiment, the orthodontic device includes an extra-oral vibration source (or actuator), an extra-oral processor that controls the vibration source to capture and transmit usage frequency and duration, and a battery that drives the extra-oral vibration source. And a mouthpiece comprising a bite plate that allows contact with the occlusal surface of the patient's teeth and at least one of the lingual and buccal surfaces. A chewing patient holds the device in place while in use, the mouthpiece is coupled to an extraoral vibration source, the orthodontic device is hermetically sealed and vibrates at a frequency of 0.1 to 400 Hz. be able to.

  In yet other embodiments, the device is completely in the mouth and the bite plate described herein also has a power source, vibration source and processor directly on it, but the processor is omitted in low cost devices There is also. The device should be hermetically sealed or otherwise waterproof, so a wireless rechargeable battery is preferred, or a long-lasting battery may be coupled to a low cost device. Since the space inside the mouth is limited, a coin vibrator or other micro-vibrator coupled with a membrane button off / on switch, for example, which is preferably accessible by molars, is probably the optimal vibration source. The placement of such electronic components on the bite plate can be either buccal, lingual or occlusal depending on the size of the component, but preferably it is lip-free as it interferes with use and aesthetics. Not on the side (under the lips).

  A method of orthodontic remodeling is also provided and includes biting the bite plate as described above and operating the vibrator for more than 5, 10, 15 or 20 minutes. This may be daily or preferably twice a day or more. As the device accelerates orthodontic remodeling, the overall orthodontic treatment time is reduced, for example from an average of 2 years to 1 year.

  The use of the word “a” or “an” when used in conjunction with the term “comprising” in a claim or in the description must indicate that the context is not. Means one or more than one.

  The term “about” means a plus or minus tolerance value of measurement error, or ± 10%, unless a measurement method is specified.

  The use of the term “or” in the claims is used to mean “and / or” unless it is expressly specified to refer only to an alternative, or where alternatives are mutually exclusive. .

  The terms “comprise”, “have”, “include” and “contain” (and variations thereof), as used in the claims, are unrestricted linking verbs. Yes, allowing other elements to be added.

  The phrase “consisting of” is closed and excludes all additional elements.

  It is recognized that the phrase “consisting essentially of” excludes additional material elements but encompasses elements other than materials that do not substantially alter the properties of the present invention. Thus, the term “consisting essentially of” is intended for bulky headgear, toothbrushes designed to hold the device in place during use, which will fundamentally change the nature and use of the device. Elements such as hair and laser are excluded. However, this phrase does not include elements such as additional LED lighting, speed dials or other control buttons, battery charge indicators, accessories, bite plate shape variations, wiring variations, software variations, processor or communication technology Do not exclude.

  As used herein, all scientific names are in accordance with standard dental usage. Therefore, the cheek side refers to the surface facing the cheek, the lip side refers to the surface facing the lips, the lingual side refers to the surface facing the tongue, and the face side refers to the surface facing the lips and cheeks. Both are included.

  What is meant in this specification by “U-shaped” is the curvature of the dentition followed by the bite plate, for example, the tooth biting surface has a substantially U-shaped curvature.

  What is meant by “lingually shaped” is that the device has a tongue shape (eg, a hole is plugged) so that it can function as a device, eg, a palatal dilator or fixture. U).

  When referring to "teeth" or referring to similar phrases herein, what is meant is the entire dentition, for example the teeth of both dental arches. Where fewer teeth than the entire dentition are intended, mention is made of the upper teeth, lower teeth, or “parts” of the teeth or specific teeth or dental arches, identified by name. Nonetheless, the bite plate need not contact every single tooth, as some malocclusions by definition can cause one or more teeth to deviate significantly from a straight line. This phrase also allows some clearance in the molars to accommodate the change in the size of the dentition and if the molars have grown over the age of 20-25 years, if any. Alternatively, molars may be removed to provide additional space for the remaining teeth, so most patients do not have a complete set of adult teeth. Thus, a bite plate intended to contact all the teeth of the average young patient may not reach the molars of older or larger patient molars or patients with more mature dentitions .

  What is meant by “treatment modality” is a mode of treatment that produces benefits from orthodontics.

  By “treatment modality source” is meant a device or component of a device that provides a therapy. For example, vibration is an orthodontic treatment and the vibration source provides vibration. The vibration source is sometimes called a vibrator. Another treatment is infrared or ultrasonic light, and an LED or laser may be an example light source.

  As used herein, a “bite plate” is an instrument that is worn in the mouth and held by a patient who “bites” the bite plate by making total contact with the occlusal surface of the tooth Means.

  An “extraoral drive” is an extraoral component that provides a therapy, and in a preferred embodiment, a housing, a processor, a battery or others having a therapy source, such as a vibrator or laser, for example. And a wiring operatively coupled to or required to operate it, the housing having a socket for receiving the connector of the intraoral bite plate. The housing is preferably water resistant or waterproof.

  By “socket” is meant a hole or recess or female end into which a male end connector fits.

  A “housing” is used as an outer surface or container for an extraoral drive.

  "Orthodontic remodeling" is used to match the definition accepted by the field, and minimally so that the teeth are gradually moved and / or repositioned to the desired position. Tooth resorption refers to realignment of teeth through bone remodeling procedures with sufficient force to achieve osteoclast activity on the high pressure side and osteoblast activity on the decompression side .

  “Orthodontic force” is used to match the accepted definition in the field and refers to the stable (stationary) realignment force required for orthodontic remodeling procedures. See micropulse.

  “Micropulses” are extremely small vibrations or periodic forces that are currently known to produce orthodontic remodeling that is reduced in time by as much as 50% when combined with orthodontic forces. .

  An “orthodontic remodeling appliance” or “orthodontic appliance” is used to conform to the accepted definition in the field and provide such orthodontic force, thereby realigning the teeth Pointing. The term includes a variety of devices, such as braces, aligners, positioners, herbs, arrowhead instruments, palatal dilators, pendulums, nonces. The term does not include dental cleaning devices such as professional cleaning tools such as electric toothbrushes, scalers.

  “Headgear” is used to match the definition accepted by the field and is used to provide orthodontic force in a specific direction that cannot be easily achieved using the point of attachment in the mouth. Refers to the means of wearing the head and neck. As an example, the headgear helps to correct Class II malocclusion by pulling the lower jaw forward.

1 illustrates one embodiment of an orthodontic treatment system with all electrical components outside the mouth and housed in a housing. 1 illustrates one embodiment of an orthodontic treatment system with all electrical components outside the mouth and housed in a housing. Fig. 3 shows a second embodiment of an orthodontic treatment system with all components in the mouth. Fig. 3 shows a second embodiment of an orthodontic treatment system with all components in the mouth. 1 shows a block diagram of an example for controlling an electronic device used with the system of FIGS. It is a figure which shows an example dental treatment network. FIG. 6 illustrates an example process for treating a patient. FIG. 6 illustrates an example process for capturing data and providing data for feedback purposes. FIG. 2 illustrates an example system for leasing, renting, or purchasing equipment. FIG. 6 illustrates an example process for increasing the efficiency of a clinic and case. FIG. 10 illustrates an example process for comparing the difference in pain level and improved treatment time for a patient treated with and without an instrument. FIG. 10A shows a flat U-shaped base, upper and lower lingual and facial edges, and a shaft that fits into a mating socket on an extraoral housing (not shown). It is a perspective view of the bite plate from one angle. FIG. 10B shows a flat U-shaped base, upper and lower lingual and facial edges, and a shaft that fits into a mating socket on an oral housing (not shown). It is a perspective view of the bite plate from one angle. FIG. 11A shows a bite plate core from two angles with a biocompatible overlay having an edge and a desired final shape molded thereon. FIG. 11B shows the bite plate core from two angles with a biocompatible overlay formed on it, having an edge and the desired final shape. FIG. 6 is a top view of a bite plate that more clearly illustrates a groove into which a jump limp that fits into a corresponding recess in a shaft, overhang, pin, cylindrical shaft, and socket (not shown); . FIG. 13A shows an embodiment of a USB from two angles where the USB is housed inside an access hatch connected to the body of the housing, and the USB functions for both charging and data transmission purposes. is there. FIG. 13B shows an embodiment of the USB from two angles where the USB is housed inside an access hatch connected to the body of the housing, and the USB functions for both charging and data transmission purposes. is there. FIG. 14A shows an example usage data chart. FIG. 14A shows the overall chart design, providing the% of the day, the% of the 30 days, the minutes used, and the number of sessions on a single graph. A small horizontal bar containing gray usage data at the bottom has a movable cursor or scroll icon (see a small box at the end of each), allowing the user to select a data range for viewing I have to. Thus, the patient, parent / guardian or health care worker can view the entire history of months or years, or can focus on the most recent month of use. FIG. 14B shows an example usage data chart. FIG. 14B shows how the data for one day (see point) can be selected for display by passing the cursor (arrow) over the data. The selected date data is then displayed in a summary on the right side of the top. An example circuit diagram is shown. An example circuit diagram is shown. An example circuit diagram is shown. A graph of Newton's force on the Y axis and Hz frequency on the X axis is shown, and the patient's response to various combinations of force and frequency is graphed. In general, the higher the frequency, the less force should be used to provide a device that will have adequate patent acceptance. It is a figure which shows the pin on a circuit board, and the solid state sensor for sensing a motor speed. A bite plate without an inner core is shown, which is molded to cover the extraoral actuator and has an access hatch for maintenance of the electronic equipment. A bite plate without an inner core is shown, which is molded to cover the extraoral actuator and has an access hatch for maintenance of the electronic equipment. The absence of an inner core with a notch around the canine moves the molar end of the bite plate relative to the leading edge, which allows European, Asian and Damon dental arches A bite plate that can be adapted to the form is shown. It is a figure which shows the relationship between a frequency and a radian velocity.

  In accordance with one embodiment of the present invention, non-stationary forces (eg, vibrations) are utilized to facilitate skull remodeling in conjunction with orthodontic treatment. The system can be used to treat all forms and segments of dental malocclusion, skull abnormalities, bone defects, odontofacial deformations, where bone remodeling plays a physiological role . The system can be used exclusively on the upper jaw, exclusively on the lower jaw, or in a double dental arch fashion (both upper and lower jaw simultaneously). In addition, the system can be used to treat the entire dentition, treat cases that exhibit some combination of natural or unnatural tooth loss, and remodel bones of edentulous patients. Patients of any age and patients with any medical profile can be treated. The system may be used by patients who are receiving some type of medication.

  1A-1B illustrate one embodiment of an orthodontic device 10. The device 10 has an oral bite plate 20 that is inserted into the patient's mouth. The bite plate 20 is connected to the extraoral vibration source 30. The device 10 is held by the patient's jaw 40 pressing the bite plate 20 and secures it between the dental arches 42. Since no other means of attachment is required, the device is greatly simplified, making it easier to make the patient comfortable, thereby functioning to greatly improve compliance.

  The bite plate 20 can be engaged with any part of the dentition 32 and is not limited to a particular dental arch, region, quadrant, or single tooth, and is a natural or denture tooth Without being limited to any of the rows, this document illustrates a generally beneficial shape that contacts all teeth. By “all teeth” herein is meant that the bite plate contacts the most mesial teeth of both the upper and lower dental arches from the most distal teeth. However, one or more teeth may not actually touch the bite plate due to malocclusion. If malocclusion is severe, it can be fitted through a type of riser that peels and affixes the bite plate to contact unaligned teeth, or a custom bite plate can be constructed .

  The extraoral vibration source 30 in this embodiment is actuated by pressing a button 38 mounted on the extraoral device. The vibrator stimulates the patient's chewing pressure, alternatively, by the microprocessor 39 or by some other mechanism that translates external stimuli into the function of the device, including humidity or temperature sensing and salivary mineral content sensing. Is activated by sensing as

  More particularly, the extraoral vibration source 30 includes a vibrator or actuator 54, which may be an offset motor, a piezoelectric vibrator or any other means for creating vibration. Actuator 54 is operably coupled to processor 39, which is operably coupled to battery 62. The extraoral vibration source 30 is also connected to the bite plate so as to transmit the force generated by the actuator 54 to the bite plate 20 and thereby to the teeth and the user's bone. The entire extraoral vibration source 30 is preferably enclosed within a housing (not depicted in detail in this figure), which is preferably watertight or at least water resistant. In addition, wiring, software, connections, couplers, etc. are required to create a functional vibration source, which is not depicted in detail in this figure, but various methods for implementing them are known in the art. Known.

  In another embodiment shown in FIGS. 2A-2B, the extraoral vibration source 30 is positioned in the mouth and the bite plate holds the components necessary to generate and apply the force. This embodiment can generate a non-stationary force and apply the force to either the upper or lower dental arch, or both. This particular embodiment involves a double dental arch configuration that works with both dental arches 40 of the tooth. The patient inserts the bite plate 20 into the oral cavity and chews it downward to stabilize the device 10 between the teeth regardless of which dental arch 40 the device is activated for use with. And hold. The vibration source 30 housed in the mouth compartment 36 is activated by pressing a button 38, thereby actuating the actuator 54 and causing the entire bite plate to vibrate. The vibration source 30 may alternatively be actuated by sensing the patient's chewing pressure as a stimulus by the microprocessor 39 or by some other mechanism that converts external stimuli into device function.

  Although the central line of the device and the compartment in the mouth on the facial side are shown, it may be housed on the lingual side, or more than one vibrator may be provided on the molar, for example. The entire mechanism is hermetically sealed to make it waterproof.

  In one embodiment, the device functions when the patient applies sufficient force by chewing the device or otherwise pressing the jaw against the device. This allows the device to be controlled to provide a periodic force when the correct amount of force is applied. In this embodiment, the device is 1) a microprocessor and compliance software and reporting system, 2) the ability to apply any level of periodic force, and 3) periodic only when the teeth apply the correct force to the device. Including the ability to give power. The actuation trigger can also be associated with any other stimulus, including temperature or humidity sensing as well as saliva mineral content sensing.

  FIG. 3 shows a block diagram of an example control electronics used with the device. Functional electromechanical components include a processor 39 which may be a low power microcontroller. The processor 39 stores instructions and data in its memory 52. The processor drives an actuator 54 such as, for example, an electric motor or a piezoelectric device. The system of FIG. 3 receives energy from a battery 62 that may be rechargeable. The processor 39 can be programmed or updated or transmit data via a communication port 60, such as a USB port, or a wireless transceiver 58 connected to an antenna 59. The battery 62 may be of any type and may be rechargeable with a docking port that charges the battery when inserted therein. The processor 39 can also capture patient tooth data by communicating with an optional sensor 64 if desired. The processor 39 can also simply transmit its operating parameters via the communication port 60 or the wireless transceiver 58 to provide dental specialists such as dentists, orthodontists, clinical laboratory monitors, hygienists, treatment coordinators, staff members, A patient or a third party can monitor the progress of treatment as needed.

  Actuator 54 can be attached directly to the bite plate or platform as shown in the intra-oral embodiment of FIG. 2, or it can be out-of-mouth as shown in FIG. In operation, a bite plate or platform of any shape or thickness, which can be composed of any material, vibrates to deliver the required force. In a preferred embodiment, the bite plate includes a solid inner core, which is hard enough to transmit vibration to the teeth, for example 30-40 Shore D, softer, For example, it is covered by a biocompatible coating or housing of 60-90 Shore A.

  In still other embodiments, the inner center is omitted, and instead the bite plate is made of a stiffer durometer material, eg, made at approximately 70-80, or 75 Shore A, so in the housing The vibrations and the vibrations in the middle along the bite plate will be approximately the same, with no loss of more than 0.05 N when traversing the shaft and half of the bite plate. In such embodiments, the shank needs to be thick enough to allow a stable connection to the extraoral component, but as an alternative, the bite plate covers the extraoral housing As a result, the degree of connectivity is no longer a problem. In such an overcoated embodiment, it may be desirable to have an off-mouth access area so that the manufacturer can contact the electronics for repair. Such areas are preferably not easily accessible by the user. Applicant's test of three different materials omitting the inner core / frame did not show any reduction in force amplitude as long as the vibrating element was securely attached to the mouthpiece.

  To measure the force, the bite plate is clamped on both sides with a clamp to mimic a loose bite, and a force sensor fed from a small hole in the middle clamp along the bite plate Measure the force when the device is activated. The force is also measured at the socket of the driving device outside the mouth during operation. In the current commercial embodiment, it has a rigid inner core made of polycarbonate, the force at the socket is 0.28 N, and the core force along the bite plate is 0.25 N, thereby The loss is only 0.03N (-10%). In our testing of a bite plate without an inner core, if a 15% loss is observed, the motor weight is modified accordingly to deliver an additional 0.2-0.25 N to the bite plate. However, these experiments are not yet perfect.

  There are two parameters that can be adjusted to increase the force: mass and acceleration. The acceleration is adjusted by the square of the weight radius. The mass is controlled by the choice of weight material (eg tungsten, steel, etc.) and its dimensions.

  The eccentric rotating mass (ERM) is driven by a small DC motor. The force (F) utilizing ERM is proportional to the radian speed of rotation (ω), the mass of rotating weight (m), and the radius of gravity center of gravity (r). The formula given relates to the effective (root mean square) force applied.

  The system uses the capacitive sensing of the metal ERM to sense the force frequency and hence the vibration caused by the rotating ERM.

  Frequency = 2πω

Relationship between frequency and radian velocity
^* Square of radius = 2 × offset, see FIG.

  One rationale for omitting the core is to reduce parts and thereby reduce costs, but an important advantage is that the bite plate is thinner, which increases comfort It is possible that the user can cut off unnecessary portions of the bite plate to fit as needed. At present, the bite plate is offered in six different sizes, but if the bite plate has a thickness of 2 mm or less and can be cut off with scissors, it can be reduced from 2 to 3 is expected.

  In addition to the reduced parts and process time costs already emphasized, the bite plate and mouthpiece become more flexible if the rigid core is additionally removed. This allows us to design a “moderately flat” (between dimensional large and small flat size), which bends (to be small) or spreads (to large) This could potentially apply to all users. This means a reduction to one size mouthpiece.

  In addition, if a small wedge is cut out on the lingual side of the bite plate around each incisor, the width of the bite plate can be adjusted to fit snugly, which allows European, Asian and Damon teeth It can be adapted to each of the row bows, some of which are not possible with current designs. FIG. 19 shows such a wedge, since the bite plate is made of, for example, a thermoplastic elastomer such as medical grade silicone, it is minimal at the wedge to accommodate changing dental arches. It can be bent by the buckling action. Upon removal, the bite plate returns to its original configuration.

  The outside of the bite plate is preferably made of silicone rubber, polypropylene, HDPE, etc. that does not have an unpleasant flavor, is biocompatible, is safe and approved by the Food and Drug Administration. In another embodiment, the bite plate coating and other parts of the device that contact the tissue of the mouth have flavor choices for additional comfort during use of the device. In yet another embodiment, the device is activated, cured and / or coagulated by a snug fit polymer, for example by adding a boil or bite polymer, or light and / or chemicals. It is coated with a polymer or the like that can be made.

  The device may have one or more engagement points across the dentition, or may engage the entire dentition as a whole and on both dental arches simultaneously. The system embodied as the device described herein is between about 0.1 Hz to about 1200 Hz, but preferably 1 to 400 Hz, especially pulsating or vibrating at a frequency of 5 to 40 Hz or 30 Hz.

  Since there is some data that indicates that ultrasound is effective in promoting bone remodeling, ultrasound frequency may be used. However, a successful use in dental applications has not yet been shown. Furthermore, the use of ultrasound is quite stimulating near the head of such a patient, so even if ultrasound has been shown to have osteogenic effects, it is not worth it I have to. The device has no effect if the patient does not want to use it.

  In one embodiment, the engagement with the dentition can transmit a force of approximately 5 Newtons (5N) for approximately 20 minutes per day at a frequency between 0.1 and 400 Hz as discussed above. However, forces less than 1 Newton, especially 0.1-0.5 or 0.2-0.3 N, are more preferred by patients and are clinical without causing root resorption that occurs when too much force is applied. Has been shown to be effective. Excess forces, especially large forces with high frequencies, are generally unpleasant for the patient, and in a preferred embodiment, these parameters can be adjusted within clinically acceptable limits. Commercial devices always use 0.25N, which may be rounded to 0.2N in the literature.

  Although prescribed clinical force application may span any combination of duration, frequency, and time of day, current devices are allowed to be used for 20 minutes per day . Once the 20 minute duration of operation is complete, the device can automatically stop. Provide feedback to the patient regarding the elapsed time in the current session of operation and the remaining time Pacing indicators in the form of audible sounds, visible light, cycle shutters or any other means are also useful. Such an indicator may be of any form and frequency. The prototype system embodies an indicator. The first 15 minutes are ½ sounds at 5 minute intervals, representing sounds at 5 minutes, 10 minutes, and 15 minutes, then the last sound at 19 minutes and the remaining use by the user for 60 seconds Inform you that you have time. Other indicators and / or suitable treatment intervals can also be used to alert the patient. For example, the specialist can specify treatment intervals by combining and adapting usage patterns to reach 20 minutes, for example 4 × 5 minutes or 10 × 2 minutes, or any other combination thereof.

  After the device stops, the patient simply releases the biting pressure from the oral bite plate and removes the device. Data capture on usage frequency and duration is updated in real time. Therefore, the device display of this data after use will indicate that one session has been added and the duration of use has been added by 20 minutes compared to the same device immediately before this session.

  In one embodiment, battery 62 is rechargeable and can be plugged into its charger during use. Alternatively, the device can embed a battery 62 in its housing, and the entire device is placed in a rechargeable base (or the battery need not be charged). The battery charging operation may also be performed using the power received from the USB port 60, which is particularly preferred. Therefore, the charging port and the data port may be the same port. Or any suitable computer or electrical connection may be provided to charge the battery. For example, the battery can be charged using RS-232, Firewire, or via a 5V hook. Furthermore, the battery can be charged using a standard wall-mounted DC converter.

  If a USB port is provided, it should be protected inside the enclosure and connected via an access hatch or a removable cap that is preferably connected or somehow attached to the body of the enclosure. Should be. Although not essential in terms of operability, it is preferable that the access hatch and battery can only be connected using specific tools, for the reason of making the device safer and reducing the legal burden. is there. Alternatively, a waterproof USB port can be provided, but this increases the cost. Both the battery and the processor are preferably inaccessible to the patient.

  In one preferred embodiment, the device utilizes an inductive charging device having a base plate that contacts the live part when the device is secured thereon. Thus, no cable is required, thus making it easier to produce a waterproof device.

  The device is preferably hermetically sealed so that it is airtight and watertight, or at least water resistant, and can withstand exposure to water or moisture. It can and should be stored at room temperature. The battery 62 used in this particular embodiment is memory free and maintenance free. The device can have a charger base or can be inserted long enough to charge for subsequent use.

  Utilizing periodic force application can result in bone formation and / or remodeling and rapid tooth movement that can occur without bone formation or remodeling. Bone remodeling and facilitated tooth movement across all types of movement includes rotation, translation, penetration, extrusion and tilting. Such induced and promoted bone remodeling can be performed in any plane, including horizontal and vertical, anterior and posterior, mesial and distal, and facial (eg buccal and labial) and lingual Related to both the alignment and movement of the teeth within.

  Periodic force delivery to the teeth and skull can be done by contact with any tooth, dental collection, including dental collection or dental arch, or any form of interaction, or with a brace or aligner or positioner Can be facilitated by contact. The contact surface can also include any dental tissue, including dental tissue, enamel, dentin, cementum and medulla, and instruments, especially an aligner tray, which can be any commercial or non- It can be a commercial variety or design.

  The device can be used to move either a single tooth, an entire dentition or any combination of sets of teeth. Teeth that are moved as a result of non-stationary forces delivered by this device include natural teeth without any toothwork, dental work, including restoration by the work of any natural material with any material Natural teeth, crown and bridge work, teeth treated with endodontics, teeth treated with periodontal disease, teeth surrounded by hard and soft tissue treated with periodontal disease, and orthodontic or Any type of dental implant is included, including micro-implants used for the purpose of moving teeth. The proposed system may be used in conjunction with the treatment of trauma to any type of tooth or dentofacial surgery or any soft or hard tissue structure.

  The system may be used in conjunction with tongue braces, facial braces, or any combination over either quadrant of either or both dental arches. It is also intended to be compatible with robot-based or other techniques for optimizing the bending of wires. The system is also compatible with transparent aligner technology treatment plans, including Invisalign® treatment approaches, both with and without force addition devices.

  The system can be used in conjunction with a new treatment, starting from the first appointment at which orthodontic treatment begins, or at any point in the treatment phase up to and including the last clinical phase. It can also be incorporated into ongoing treatment.

  In another aspect, the vibratory dental device is used in conjunction with any currently used or under development chemical, biochemical and tissue engineering treatment techniques to promote tooth movement or skull Can be remodeled. Such treatments may include growth factors, cytokines, matrix metalloproteinases (MMPs), tissue inhibitors of metalloproteinases (TIMPs) and extracellular matrix molecules. In addition, periodontal tissue or movement surrounding the root (s) should be administered by administering to the patient tissue remodeling material and / or angiogenic material (s) for both repositioning or stabilization Tooth remodeling can be promoted. The preferred substance (s) will bind to and activate the relaxin receptor in tissues that fix the teeth or other cranial structures. Most preferred is relaxin or an analog or mimetic thereof that combines tissue remodeling activity with angiogenic activity. Analogs include peptides, oligomers, fragmented chromosomes, etc., which have an active region of natural relaxin, and mimetics are typically less than 2 kD and are designed to mimic the activity of natural relaxin Containing small molecule drugs. Alternatively, the substance (s) with excellent angiogenic activity may be selected, such as VEGF, bFGF, estrogen, nitrous oxide, naltrexone, and the like. As a further alternative, collagenase or other tissue softening enzymes may be utilized to facilitate periodontal tissue remodeling according to the present invention.

  FIG. 4 shows an example dental treatment network. Device 10 transmits actuation and dental / medical information while it is fitted into the body of patient 1. This data is received by the local processor 99. A local processor 99 uploads information via a wide area network 102 such as the Internet. These data can be received at the workstation 120 by a treatment professional such as a dentist or orthodontist. The information can also be sent to one or more diagnostic specialists 130 who review the information and then make recommendations to treatment specialists over the network 102. Information can also be sent to device manufacturer 110 and any other required dental manufacturer 140.

  An Internet community, including a company, service provider, manufacturer, or marketer who supplies one or more teeth, is connected to the network 102 and directly with the user of the client workstation 99 or indirectly through the server 100 Can communicate with each other. The Internet community gives client workstations 99 access to orthodontic and dental specialist network stations. In addition, the Internet community also provides access to various support members, such as financial companies, leasing companies and other service providers.

  In another embodiment, the device can send data to a smartphone, which can make the user aware of using the device, or in a clinical trial or by a dentist or parent Data can also be sent to a third party for use.

  The server 100 may be an individual server, but the server 100 may be a group of redundant servers. Such populations can automatically fail over data and protect against both hardware and software failures. In such an environment, multiple servers provide resources independently of each other until one of these servers fails. Each server can continue to monitor other servers. If one of the servers cannot respond, the failover process begins. The surviving server acquires the shared driver and volume of the failed server and implements the volume accommodated on the shared drive. Applications that use shared drives can also be started on servers that survive after a failover. As soon as the failed server is booted and communication between the servers indicates that the server is ready to own its shared drive, the server automatically starts the recovery process. In addition, a server farm may be used. Network requests and server load conditions can be tracked in real time by the server farm controller, and the requests can be distributed throughout the server farm to optimize responsiveness and system capacity. If necessary, the farm can put additional server capacity in the service as the traffic load increases, automatically and without the user being aware.

  Server 100 can also be protected by a firewall. When the firewall receives a network packet from the network 102, it determines whether the transmission has been authenticated. Once authenticated, the firewall examines the header in the packet to determine which encryption algorithm was used to encrypt the packet. By using this algorithm and secret key, the firewall decrypts the data and the addresses of the source and destination firewalls and transmits the data to the server 100. If both the source and destination are firewall protected, only the addresses that are visible on the network (ie, unencrypted) are those of the firewall. The address of the computer on the internal network thereby hides the internal network topology. This is called “virtual private networking” (VPN).

  The system improves device usage / wearing duration, device usage / wearing frequency, consistency in device usage / wearing time of day, and patient compliance defined as correct device usage / wearing. , Such data is captured in the form of data by the device. Compliance dictates not to overuse and underuse the device according to the instructions given to the patient by the healthcare professional. Such data can be viewed by medical personnel as shown in FIG. In this embodiment, usage / wearing instructions are provided to the patient by the healthcare professional 510. The patient utilizes / wears the device and compliance data is captured during patient use 512. After each treatment period, the device is collected by a specialist and compliance data is extracted 514 therefrom. This data is presented in a specific form that allows data analysis by medical personnel 516. As part of the active feedback process 518, the healthcare professional will then make recommendations or re-specify the device for subsequent use until the next visit or interaction between the two. This process may involve some form of reward or penalty based on compliance and usage pattern results. Alternatively, the device may be configured to automatically communicate how it is used, for example via a smartphone, to the central area, thereby enabling near real-time monitoring.

  As shown in FIG. 6, data can also be provided directly to either the patient or legal guardian for feedback purposes as well. In order to provide either active or passive feedback to the patient user, the device can be configured as seen in FIG. Such data generation and observation can be enabled by request via download via some form of electronic media, or may be provided as a default setting in use. For example, in use, the device may provide visual feedback 614 at the request 612 from the patient or automatically. Data can be downloaded 616 to an electronic medium 620 such as a flash drive, information can be sent to an expert 618 for feedback and analysis, or sent directly to the patient or to the patient's legal guardian Can also be 619.

  FIG. 7 illustrates an example distribution system by a company 700, where the device 10 is leased or rented to a patient 730 through an orthodontic office 720 and the device is used as part of a treatment. Allows proportional patient fees. Alternatively, the patient can rent or lease the device directly from a commercial sales organization or manufacturer, as illustrated in FIG. Instead of leasing or renting the device 10, the patient can also purchase instruments from either an orthodontic office or a medical specialist office 720, or from a commercial sales organization or manufacturer 700.

  An additional aspect of the proposed system relates to the improvement in efficiency it allows and is possible in orthodontic or medical specialist clinics. It shortens the duration of treatment, increases the number of new starts, improves the economic efficiency of implementation on any measurement criteria, attracts new patients, recaptures those who have previously refused treatment, and optional Can be used to improve the relationship of contracted or contracted dental / medical professionals upstream or downstream of a department or field of expertise.

  The efficiency of medical professionals increases as a result of patients using the system. Such improvements include, for example, increasing the number of new cases to start, reducing the duration of the overall treatment time, reducing the frequency of visits for recall or adjustment, as shown in FIG. 8, or May include metrics such as reduced chair time. In FIG. 8, the orthodontic clinic has the clinic and case efficiency in a steady state without the device 810. As the adoption of this technology increases and devices are incorporated into patient cases, improvement in the clinic and case efficiency are achieved 820. Such efficiency improvements may be part of any stage of any maloccluded orthodontic treatment, depending on any archwire or appliance type, including all wire sizes, shapes and compositions, or It can happen as a result.

  FIG. 9 is an example process for comparing differences in pain levels and completeness of clinical outcome, respectively, for patients treated using the devices devised herein and patients treated without them Indicates. FIG. 9 illustrates that as a result of utilizing the device, the patient's pain and discomfort are reduced, and the treatment time is also substantially reduced (as much as 50% according to compliance). In FIG. 9, a healthcare professional is treating a patient without the device of the present invention 910, pain level and / or discomfort is observed by the treating professional or reported by the patient. The health care professional then utilized the device of the present invention to treat the patient and captured 920 the pain level and / or discomfort observed or reported by the treating professional. It is possible to analyze the difference in the level of pain in the patient when treated using the device and when not treated. The device treated the patient with less pain and the outcome of the treatment was in the form of improved tissue integrity. Similarly, treatment time has been shown to improve by 50%, and this level of benefit has been clinically demonstrated.

  10A-10B show an improved bite plate 1000 that has a generally U-shaped base 1001 that contacts the occlusal surface of the tooth, the base having an anterior edge and a posterior edge. And one or both edges have edges for contacting the facial and lingual surfaces of the teeth and / or gums. Thus, an upper lingual edge 1002, a lower lingual edge 1003, an upper facial edge 1005 and a lower facial edge 1006 are shown. In this example, the lingual edge contacts only the incisor and / or canine, but not the molar. However, the edges can be varied in length to contact all or part of the teeth. Except when specifically designed to correct extreme deformation, it is preferred that at least one edge contacts each tooth.

  Also shown in FIGS. 10A-10B is a shank 1008, which is part of the bite plate 1000 and mates with a corresponding socket in the extraoral housing (not shown here). More particularly, a cylindrical shaft 1009 is shown having a groove (see FIG. 11) into which the jump ring 1010 fits and mates with a corresponding recess in the socket. An optional overhang 1112 is also shown and can be configured to provide an appropriate surface to allow the user to push the shank into the socket. Because of this snap-fit feature between the bite plate and the outer casing, the bite plate can therefore be reversibly connected to the outer casing, thereby simplifying cleaning and / or storage. Is possible.

  The thickness of the biocompatible overlay material can be adjusted to compensate for various patient biting configurations (open, deep, flat), which is disclosed in US20130005634, which is incorporated herein by reference. It is described in detail. In most instances, however, the bite plate is slightly thinner at the distal end than the mesial end, and adapts to the nature of being attached with the hinges of the temporomandibular joint and facial skeleton.

  Thus, the U-shaped bite plate can contact two posterior ends that can contact one or more distal or posterior teeth and one or more mesial or anterior teeth. If it has a forward end and a thickness E, and the thickness E is between 2 and 10 mm, the bite plate may be one of three configurations.

  a) The thickness E does not substantially change from the front end to the rear end,

  b) Thickness E increases from E at the front end to E plus 0.5-10 mm at the rear end.

  c) Thickness E increases from E at the rear end to E plus 0.5-10 mm towards the front end.

  Although the shaft part on the bite plate is shown, the bite plate may include a socket, and the component outside the mouth may have the shaft part. Furthermore, as an example of a reversible coupling mechanism, a cylindrical shaft with a jump ring (cylindrical type snap fit) around the circumference has been shown. Cantilevered snap-fits, spherical snap-fits, push-down push pins and sockets, screw-on screw fits and the like.

  FIG. 11 shows a bite plate core 1007, typically made of resin, metal or ceramic having a durometer that is stiffer than the outer surface, allowing the shaft 1008 to be locked into the socket. Therefore, sufficient rigidity is given to the shaft portion. A cylindrical shaft 1009 has a groove 1113 into which a jump ring 1010 fits. It also features a lock pin 1011 and an orientation pin (not shown), which prevent the bite plate from being inserted upside down. Generally, at least 40 Shore D plastic is used for the core, but metal or ceramic can also be used. A coating is provided over the core to provide the final shape of the bite plate as shown in FIG. Such a coating should be a 40-70 Shore A biocompatible soft polymer, especially medical grade transparent silicone.

  FIG. 12 shows a top view of the bite plate, more clearly showing the core 1007, shaft 1009, overhang 1112, pins 1011 and jump ring 1010, and the other edge of the overcoat giving the actual shape of the bite plate. It is illustrated.

  FIGS. 13A-13B show the entire device including the bite plate 1000 and the extraoral component 2000. The extraoral component comprises a housing 2001, which is ergonomically and aesthetically shaped and has an on / off switch 2005 such as a membrane button and LED indicator illumination 2006. Both the LED and the on / off switch are preferably contained within the same membrane, which simplifies manufacturing and increases reliability.

  There are batteries, processors and vibrators inside the enclosure as described herein, but are not shown in detail in FIGS. 13A-13B. Also shown is an access hatch or cap 2002, which is connected to the body of the housing by a bridging steel 2004. This prevents the cap from being lost. As used herein, “binder steel” refers to any form of attachment, including hinges or coiled lines. Inside the hatch you can see the USB connector 2003, which functions to transmit data and allow the rechargeable battery to be charged, is positioned inside the housing and cannot be touched by the patient .

  In a preferred embodiment, the access hatch can be opened using only a specific tool, for example via a small recess or a cantilevered snap-fit fastener. This is preferred because it reduces the legal burden and avoids certain IEC 60601 requirements. It is also preferred that the patient be inaccessible to the battery, which entails returning it to the manufacturer when / when it is necessary to replace the battery. Such a configuration further reduces the legal burden, reduces the risk of electrostatic discharge (EDS), and makes necessary modifications when the manufacturer resets the system and replaces / batteries. Desirable to make it possible to do. In addition, the battery is expected to persist throughout the duration of the treatment and rarely needs to be replaced.

  A processor collects raw usage data including date and length of use. A specific amount of Java code is included in the chip, turning the USB into a virtual flash drive, but any suitable code can be used. Thus, when the device is plugged into the computer, the code converts the raw data into a suitable chart as shown in FIGS. 14A-14B. The date is shown on the x-axis and the usage (% compliance on the same scale, fraction of use and number of uses) is shown on the y-axis. The x-axis has a scroll bar that allows the practitioner to more closely examine the data if desired (expanding the time scale).

  Daily usage is shown (maximum 30 days average daily usage (upper line, excludes daily usage), minutes used (middle line), and usage times (bottom line) (maximum Scale data). Below the graph, usage data for the validity period is summarized. In this example, the patient used the device once or twice a day, skipped several days, and the overall compliance was 94%.

  As the mouse passes over this data, the given date under the mouse is selected (see dotted line in FIG. 14B) and data for that day is displayed in the upper right hand.

  These charts are not available on the device, which lacks a flash drive and cannot be misused or overwritten by the patient. Instead, when plugged in and activated, a small amount of code embedded in the processor converts the raw data into a usable format. This allows for a minimum footprint, reduces the legal burden and still provides easy data analysis in various forms, which can be utilized by practitioners and in clinical trials. Javascript code from an open source package called “dygraphs JavaScript Visualization Library” (see code.google.com/p/dygraphs/) was used in the applicant's prototype, but any other code is also available It can be used similarly.

  Setting the time and data on the prototype device requires an external source to communicate to the device. Using a device connected to the personal computer, the user proceeds to a compliance data report, which prompts the user to initiate a file save operation using the browser, thereby causing the product FLASH. Access the drive and enter a file name such as “DateTime” to save. The browser saves the compliance report to the product FLASH drive under the given file name. This product uses the file formation data provided by the operating system in a file save operation and sets a real time clock in the device.

  The periodic force or vibration applied to the bite plate, tooth positioner, or other functional device in the mouth is at a frequency of 1 to 1000 Hz (preferably 10 to 100 Hz, and most preferably 20 to 40 Hz); A force of 0.01 to 2 Newtons (or 0.1 to 0.5 or 0.2 Newtons) over a period of 1 to 60 minutes, preferably approximately 1 to 30, or 1 to 10 or 20 minutes. This is followed by a period of recovery over a period of 2-24 hours, preferably 4-12 hours, and this cycle is repeated until the successful movement of one or more teeth.

  More particularly, the orthodontic appliance of the present invention is a vibration source capable of providing a vibration force of a force of 0.1 to 0.5 Newton or 0.25 Newton at a frequency of 20 to 40 Hz or 30 Hz. Have Excessive force is generally uncomfortable for the patient, especially forces coupled to high frequencies.

  This is illustrated in the graph in FIG. 16, which shows how higher frequencies and forces change the patient's sense of the device. The graph shows that for patient comfort, a frequency of 30 Hz should be combined with a force of less than 1 Newton, but higher forces are comfortably used at lower frequencies. In some cases. Fortunately, the study also confirmed that a very small amount of force was sufficient to significantly affect the progress of orthodontic remodeling.

  At least one study has shown an increase in (walking speed) buttocks density at 1 Hz, suggesting that lower frequencies may be effective, but to elucidate the optimal frequency for orthodontics Needs more work. Furthermore, the results applicable to the long bone skeleton will be significantly different from the optimal frequency for orthodontic applications due to the ecology of different tooth structures.

  In a preferred embodiment, such parameters can be adjusted by the patient within a clinically effective range. In addition to capturing and storing usage data, the processor can also manage force and frequency parameters, and an appropriate controller or user interface may be provided for that purpose.

  The vibration component preferably has a more stable vibrator with reduced sound and improved performance characteristics of small fluctuation frequencies and forces. Specifically, the improved vibrator, when measured at 6 inches, has a noise level of less than 55 dB, a frequency of 20-40 Hz with a variation of only 2 Hz, and a 0.1-0.1 with a variation of ± 0.05 N. Has a force of 0.5 Newton or similar.

  Frequency and force consistency is achieved herein through a feedback loop, whereby motor speed is monitored and software adjusts the motor as needed. More particularly, the motor includes a built-in encoder, which provides multiple high and low signal outputs per motor rotation. The software counts the time between all encoder events (e.g., a rotating disk with an indication thereon can be optically sensed) and compares this to a desired target value (e.g., 30 Hz). Based on this comparison, the software then adjusts the pulse width modulation that drives the motor and scales the speed accordingly to maintain the desired speed. Accurate control of speed also controls force.

  A built-in optical encoder is preferred as a type of rotary encoder, but the feedback mechanism can be any known technique. The encoder may be separate or integrated, may be an optical, magnetic or capacitive encoder, and may be a proximity sensor that is again intended to be coded. A proportional-integral-derivative controller (PID controller) is another option. A PID controller is a common control loop feedback mechanism widely used in industrial control systems.

  A DC5V motor with an offset weight and an 8-line built-in encoder is known to provide such characteristics, but many other vibrators can also provide such performance characteristics. Because of that, can be easily tested. For example, MicroMo Inc. , Has 8 and 16 line encoders built into micromotors that can be used at a variety of voltages, and many other suppliers make similar devices. The battery is preferably rechargeable lithium ion or polymer chemistry with a minimum capacity of 100 mA-hour.

  Custom devices can be built, but the components that are commercially available are less expensive. Accordingly, the motor is preferably a series SE8G DC motor from NMB Technologies. The battery is preferably a 110 mAh Li-PO battery according to Fullriver Battery (601522).

  Exemplary circuit diagrams are provided in FIGS. 15A-15C. One embodiment is described below.

  Processor: The circuit utilizes a 32-bit low power processor to control the vibration motor, USB interface and user interface. The processor connects to EEPROM or external serial flash memory for storage and retrieval of usage data. The processor also connects to a digital three-axis acceleration sensor, which is not currently used, but to monitor device orientation and vibration characteristics for both usage data and safety management It may be used in the future.

  Power: The electric circuit uses the battery charge management control device to charge the battery and monitor the state of charge of the battery. The battery voltage is adjusted to 3.3V.

  Motor controller: Motor speed is adjusted using low-side transistor switch controlled by processor via pulse width modulation (pulse width modulation or PWM, pulse width based on regulator signal information, formal Is a modulation technique that controls the pulse duration, in which case the supply and load at a fast pace, such that the longer the switch is on, the more power is delivered to the load compared to the off period. The average value of the voltage (and current) supplied by the load is controlled by changing the switch between on and off. The motor speed is determined by monitoring the digital signal from a reflective optical interrupter that detects the transition on a notched wheel mounted on the motor shaft and then detects the adjusted speed using PWM. Perceived by. To mitigate the danger caused by excessive motor speed, a dedicated voltage regulator limits the motor drive voltage to 1.2V, thereby limiting the maximum motor speed to a safe level. In addition, the voltage regulator can be disabled if a failure is detected by the processor.

  User interface: The user interface circuit drives the LED current managed by the processor. The state of pressing the button is monitored by the processor.

  Utilizing a cone beam device (GALILEOS ™ with SIRONA ™), both roots are accurately measured by imaging in all three planes (sagittal, axial and coronal views), resulting in Estimate any root resorption that occurs. This study was designed to determine if any root resorption that occurred was greater than 0.5 mm or if there was a change in the length of the root, and no significant loss was found.

  The survey also measured the distance between teeth using a dental caliper. The total distance in millimeters between the front five teeth, both upper and lower teeth, was calculated in the alignment stage. The gap between teeth due to extraction was measured directly. The overall migration rate in this study is 0.526 mm per week, which exceeds the average migration without the device.

  Applicants say that this device can safely increase the degree of progression of orthodontic tooth movement and give freedom when used with either fixed orthodontic appliances or transparent appliances. The conclusion has been reached. In particular, some patients have a combination therapy that utilizes both a fixed orthodontic appliance and a transparent aligner therapy, which is beneficial if it is assumed to combine available orthodontic treatments. Daily use for a short period of 20 minutes benefits the patient.

  A clinical trial arbitrarily extracted from Stage 3 was again performed on 45 patients at 25 grams and 30 Hz. The first valid endpoint for the study was the difference in the one-week progression of tooth movement between the device group and the sham control group.

  The results demonstrate that the devices described herein can increase the progress of tooth movement when used in conjunction with conventional orthodontics. The result was that tooth movement was promoted both in the initial alignment (2.06 times or 106% faster) stage of orthodontic treatment and in the stage where the space was closed (1.38 times or 38% faster). Is backed up. Overall treatment time was 50% faster.

  Use of the device did not increase the risk of either root resorption or loosening of TAD. The only possible device-related situations that occurred in more than one case in this clinical trial are related to tooth discomfort, tingling or numbness, all of which are common for standard orthodontic treatment Has been reported. In all cases, these situations were mild and transient and did not interrupt or require any significant modification of the treatment procedure. Overall satisfaction as well as eight unique assessments indicate that patients are well-accepted for treatment and that the use of the device is easily incorporated into their daily behavior.

  A direct clinical benefit from daily use of the device is reduced treatment time. In cases where there is a 6-8 mm extraction space, the device will secure the patient approximately 11-15 weeks at the stage of closing the orthodontic treatment space. However, considering the promotion of tooth movement during the alignment phase, the reduction to the overall treatment time can be even greater. Further improvement in overall compliance will probably increase the overall facilitation observed.

  FIG. 17 shows a pin header 1701 and a solid state sensor 1703 that enables electrostatic or capacitive sensing of motor speed. For example, one or more pins of an Arduino pin are attached to the substrate and soldered or otherwise operatively connected to the solid state sensor 1703. When a capacitive load (eg, the eccentric rotational weight 1709 of the motor 1707) is in the vicinity of the pin, the sensor detects a change in capacitance as the eccentric rotational mass or ERM 1709 passes in close proximity to the pin. By tracking such changes over time, the motor speed can be calculated and adjustments are made so that the motor speed does not change as required by the specification presented herein. Maximize sensing by creating a custom-made pin head from some nearly conductive material to take advantage of customized pin shapes.

  The distance -D- at which the pin should be placed from the ERM can vary from 0.01 mm to 5 mm depending on the sensitivity of the system and the size of the components. The sensor's ability to detect the target depends on the target's size, dielectric constant and distance from the sensor. The larger the target size, the stronger the capacitive binding between the probe and target. Materials with higher dielectric constants are easier to detect than those with lower values. Assuming that the ERM is typically made from metal, its dielectric constant is virtually infinite, resulting in excellent sensing capability for capacitive systems. The shorter the distance between the target and the probe, the stronger the capacitive binding between the probe and the target.

  Ideally, the pins are close, but they do not need to be so close that they always touch even if the device is pushed or dropped. The distance can vary from 0.05 to 2 mm, preferably from 0.1 to 0.5 mm. We used here a PCB in combination with one pin, a capacitive sensor and an ERM motor. The processor 1711 used for this was Cypress PSOC42xx CY8C4248LQI-BL483ES, but any custom or commercially available equivalent can be used. The same processor can be used for all functions of the device, or separate processors may be provided. Here we used Cypress PSOC42xx CY8C4248LQI-BL483ES to reduce the size.

  The required software is fairly simple. The time between signal fluctuations determines the speed, and the software can increase the voltage by increasing the voltage to the motor. Or vice versa. The software may be provided separately or, to some extent, may be integrated with nearby sensor components. Commercially available programmable components can be used for capacitive sensing, or custom-made devices can be built, and dedicated programming can be added thereto.

  Programmable system-on-chip (ARM® Cortex ™ -M0 central processing unit (PSoC® 4200 family of mixed signal programmable embedded system controllers with “CPU”) is preferred herein. This device has a 32-bit microcontroller unit (“MCU”) subsystem, has programmable analog and programmable digital performance, and operates from low power 1.71-5.5 to 5.5-V Enables capacitive sensing, segmented liquid crystal display (“LCD”), serial communication capability, timing and pulse width modulation, programmable general purpose input / output (“GPIO”) up to 36, integrated Bluetooth low energy communication, as well as quite Has a PSoC Creator design environment that allows easy programming and troubleshooting.

  For proximity sensing tasks, the PsoC chip described above has Cypress CapSense Sigma-Delta (CSD), which is reportedly to the best signal and water in its class for noise assignments over 5: 1. Realize resistance. Proximity sensors emit a beam of electromagnetic field or electromagnetic radiation (eg, infrared) and expect a change or return signal in this field. A sensed object is often referred to as a proximity sensor target. Different proximity sensor targets require different sensors. For example, capacitive or photoelectric sensors may be suitable for plastic targets, and inductive proximity sensors always require a metal target.

  The CapSense sensor is located in the PSoC 4200 through a CapSense Sigma-Delta (CSD) block that can be connected to any pin via an analog multiplexing bus that can connect any GPIO pin via an analog switch. Supported on all pins. Thus, CapSense functionality can be provided on any one pin or set of pins in the system under software control. To make it easier for the user, specific components are provided for the CapSense block.

  The maximum distance that this sensor can detect is defined as the “nominal range”. Proximity sensors have high reliability and long functional life because there are no mechanical parts and no physical contact between the sensor and the object being sensed.

  GPIO is a common pin on an integrated circuit whose behavior can be controlled by software at run time, including whether it is an input pin or an output pin.

Another feature that Applicants helped to reduce the size of this device was to use a smaller offset weight within the ERM. Through much research, Applicants have found that 1.9 g of 87% tungsten weight allows for size reductions by more than 50%. Of course, if 87% of the tungsten weight of 1.9g were used, the volume of the whole, the motor size is changed from 266 mm ³ to 109 mm ^3.

  18A and 18B show an embodiment of a bite plate without an inner core, where the material hardness and / or motor weight is increased to offset any damping of vibrations by the bite plate. Is done. In FIG. 18A, the bite plate 1801 has a normal vertical ridge or knot for contacting the vertical surface of the tooth and is shaped very much like the bite plate of FIG. Thus, various surfaces and shapes are not considered here. An out-of-mouth drive 1803 with an activation button 1807 has a somewhat larger socket 1808 in which a larger shaft 1805 fits (or vice versa). Therefore, the size of the shaft portion is sufficient to securely connect even without the rigid inner core portion. Alternatively, only the shank may have a stiffer material for a strong connection, or may be overmolded over a stiffer material (not shown). The current configuration has a shank 1805 that is permanently molded directly into the socket 1808 during the manufacturing process, which cannot be removed.

  However, in FIG. 18B, the bite plate 1820 is molded over a drive (not shown) or drive housing 1823 and cannot be separated therefrom. If desired, an access hatch 1830 can also contact the electronic drive 1831, which can be removed and serviced as needed. The drive 1831 is actuated by an on / off switch 1832.

  FIG. 19 shows yet another bite plate 1901 without an inner core, which has notches 1903, 1905 around the position of the canine, thereby allowing various dental arch shapes as required. It is possible to bring both ends of the bite plate close together and away from each other so that As is well known in the art, the European dental arch (see dotted line 1907) narrows continuously from the molar to the incisor, whereas the Asian dental arch (dotted line 1909). ) Is nearly parallel from the molar to the canine and has a more rounded front surface. Therefore, it is difficult to make a bite plate that fits all patients. However, the large inventory required for dedicated bite plates is expensive and takes up storage space. This solution, of course, allows the same bite plate to be adapted to a wider range of dental arch shapes, although child and adult sizes are still required. Because the material is thermoplastic, it is possible to adjust the degree of bending and the molars expand to accommodate European dental arches and narrow to accommodate Asian dental arches.

  Although the invention has been described in detail above, it should be understood that various changes, substitutions and alternatives can be made without departing from the spirit and scope of the invention as defined by the following claims. . One skilled in the art can study preferred embodiments and may find other ways of practicing the invention that are not strictly described herein. It is intended by the inventors that variations and equivalents of the invention are within the scope of the claims, and that the description, summary and drawings should not be used to limit the scope of the invention. I'm about to do it. The invention is specifically intended to be as broad as the following claims and their equivalents.

  Each of the following is incorporated by reference in its entirety for all purposes.

 60/906, 807 filed on March 14, 2007, US20080227046, US20080227047, US20100055634, US20120322018, US2013059263, US2013323669, US2011136070, 14 / 468,100 filed on August 25, 2014, November 7, 2013 61/901, 154 filed on the day.

 Kau, C.H. “A novel device in orthodontics” Aesthetic Dentistry Today 3: 6 (2009): 42-43.

 Kau, C.H. “A radiographic analysis of tooth morphology following the use of a novel cyclical force device in orthodontics” Head & Face Medicine 7:14 (2011).

 Kau, C.H., How et al., The clinical evaluation of a novel cyclical force generating device [AcceleDent (registered trademark)] in orthodontics, Orthodontic Practice 1 (1): 10-15 (2010).

 Kopher RA and Mao JJ. Suture growth modulated by the oscillatory component of micromechanical strain. 2003. J. Bone and Min Res. 18 (3) .pp.521-528.

 Krishtab et al., [Use of vibratory action on the teeth to accelerate orthodontic treatment] [Article in Russian] Stomatologiia (Mosk). 1986 May-Jun; 65 (3): 61-3.

 Nishimura et. Al. Periodontal tissue activation by vibration: Intermittent stimulation by resonance vibration accelerates experimental tooth movement in rats. 2008. Am J Orthod Dentofacial Orthop 133 (4) pp. 572-583.

 Peptan AI et. Al. Responses of intramembranous bone and sutures upon in-vivo cyclic tensile and compressive loading. 2008. Bone (42) pp. 432-438.

 Vij K. and Mao, JJ. Geometry and cell density of rat craniofacial sutures during early postnatal development and upon in-vivo cyclic loading. 2006. Bone (38) pp. 722-730.

 Werner, Alison. “Acceleration by Vibration.” Orthodontic Products (2011): 31, 35.

Claims (21)

An orthodontic remodeling device,
a) a vibration source outside the mouth,
i) actuator,
ii) a processor that controls the actuator and captures and transmits device usage data; and iii) the vibration source comprising a power source that drives the actuator;
b) Basically composed of a bite plate that allows contact with the occlusal surface and allows contact with the upper and lower buccal sides of the patient's teeth, with the patient biting on the bite plate An oral appliance that holds the orthodontic remodeling device in place during use, and
(C) the vibration source is coupled to the mouthpiece;
(D) when the orthodontic remodeling device vibrates at a single frequency selected to be between 0.1 Hz and 400 Hz and is used with a brace or aligner for 20 minutes daily, the device The orthodontic remodeling device that facilitates tooth movement relative to a patient not using the device.   The device of claim 1, wherein the actuator is an offset weight motor.   The device of claim 2, wherein the offset weight is at least 87% tungsten.   The speed of the offset motor is controlled by a capacitive sensor comprising one or more header pins having a weak electrostatic (ES) field that fluctuates as the offset weight passes, and the header pins are operably coupled to a processor. Operably coupled to a solid state ES field sensor, wherein the processor detects the speed by detecting the fluctuating ES field and controls the speed such that the change is less than 2 Hz. Item 3. The device according to Item 2. The device of claim 1, wherein the bite plate is made of a single thermoplastic material.   The bite plate has a pair of notches on its lingual side at a specific position near the patient's canine so that the molar end of the bite plate is bent at least 1 cm away or 1 cm away 6. The device of claim 5, wherein the device is capable.   The device according to claim 6, wherein the bite plate has a thickness of 2 mm or less at its occlusal surface.   The device according to claim 6, wherein the bite plate has a thickness of 1.5 mm or less at its occlusal surface.   The device of claim 6, wherein the single thermoplastic material forms the bite plate and completely covers the extraoral vibration source.   The device of claim 9, wherein the single thermoplastic material is provided with an access hatch so that it can contact a vibration source outside the mouth.   The device of claim 9, wherein the device is waterproof.   The device of claim 9 which is water resistant.   The device of claim 1, wherein the device vibrates with a single force of 0.1 to 0.5 Newton at a single frequency of 20 to 40 Hz.   The device of claim 1, wherein the device vibrates at 30 Hz and 0.2 Newton.   The device of claim 4, wherein the device vibrates at 30 Hz and 0.2 Newton.   The device of claim 1, wherein the device vibrates with a single frequency of 20-40 Hz with a variation of ± 2 Hz and a single force of 0.1-0.5 N with a variation of ± 0.05 N. The device described.   5. The device of claim 4, wherein the device vibrates at 30Hz with a variation of ± 2Hz and 0.2N with a variation of ± 0.05N.   an orthodontic resection comprising: a) wearing a brace or aligner using the device of claim 16 and biting the bite plate; and b) operating the device for 20 minutes daily. A method for speeding up modeling, which achieves tooth movement 50% faster than when the device is not used.   an orthodontic resection comprising: a) wearing a brace or aligner utilizing the device of claim 17 and biting the bite plate; and b) operating the device for 20 minutes daily. A method for speeding up modeling, which achieves tooth movement 50% faster than when the device is not used. An orthodontic remodeling device,
a) a vibration source outside the mouth, i) an actuator having an offset weight,
ii) a processor that controls the actuator; and iii) the vibration source that includes a power source that drives the actuator;
b) Basically composed of a bite plate that allows contact with the occlusal surface and allows contact with the upper and lower buccal sides of the patient's teeth, with the patient biting on the bite plate An oral appliance that holds the orthodontic remodeling device in place while in use,
c) the vibration source is coupled to the mouthpiece;
d) the orthodontic remodeling device vibrates at a single frequency selected to be from 0.1 Hz to 400 Hz;
e) the offset weight motor is controlled by a capacitive sensor comprising one or more header pins having a weak electrostatic (ES) field that fluctuates as the offset weight passes, the header pins being operable to the processor Operably coupled to a coupled solid state ES field sensor, wherein the processor detects the velocity by detecting the fluctuating ES field and controls the velocity such that the change is less than 2 Hz;
f) The orthodontic remodeling device when the device is used with a brace or aligner daily for 20 minutes, the device promotes tooth movement compared to not using the device. An orthodontic remodeling device,
a) a vibration source outside the mouth,
i) an actuating device comprising an offset weight motor, wherein the offset weight is 87% tungsten;
ii) a processor that controls the actuator; and iii) the vibration source that includes a power source that drives the actuator;
b) Basically composed of a bite plate that allows contact with the occlusal surface and allows contact with the upper and lower buccal sides of the patient's teeth, with the patient biting on the bite plate An oral appliance that holds the orthodontic remodeling device in place while in use,
c) the vibration source is coupled to the mouthpiece;
d) the orthodontic remodeling device vibrates at a single frequency selected to be between 0.1 Hz and 400 Hz;
e) The orthodontic remodeling device, when used with a brace or aligner daily for 20 minutes, the device promotes tooth movement compared to patients not using the device.