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    US11760026B2 Original Document 20240226095257

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    Samuele Altruda

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    © All Rights Reserved
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    US011760026B2 «2 United States Patent 0) Patent No US 11,760,026 B2 Dau et al. (45) Date of Patent: Sep. 19, 2023 (58) INSTRUMENTED INTRA-ORAL APPLIAN (202001); Go6r 7mo12 (201301): 4618 COMPUTATIONALLY DESIGNED FOR 50205 201301: 4618 2362/12 (201301), OPTIMIZED FITTING AND. TAGIC 13/0008 (201301); 4638 2308100 FUXCTIONALITY {2013 01) Gd6? 220730036 01301) (68) Field of Classification Search (71) Applicant; Biomechanics Consulting and CPC ..... B29C 64/386; A61B 5/682; AGIB S'0205; Research, LLC, Charest, VA [GIB 256212, AGIC 91004: A61C (US) 9/0046; A61C 9/0053; A6IC 19/066; ‘AGIC 130004, AGB TH8S: AB (72) Inventors: Nathan Dau, Palmyra, VA (US); Rleh 2208100 CRB 2220030; AGSB 22300, Rydin, Chop ill NC (US), tT [GSI 222053, ABB 222080, AGB ‘Crandall, Charlottesville, VA (US) 2225/20; A63B 2230/10; A63B 2230/207; ‘AGB 223050, AOBB 2220003, AGB (*) Notice: Subject o any discimer, he tem of this corey pe marrmpetitey patent is extended or adjusted under 35 BABY 10/00; B33Y SO/00; B33Y 80/00, US.C. 154(0) by 1380 days. GO6F 30/17; GOST 7/0012: GO6T 220730036 (21) Appl. No. 16/156,499 See application file for complete search history. (2) Filed: Oct. 10, 2018 66) References Cited @ Prior Publication Data US. PATENT DOCUMENTS ‘US 2019/0105842 Al Apr. 11, 2019 10,893,918 B2* 1/2021 Borovinskih GI6H 50/50 2ou0ioidess AI* 12010 Kascyan 02. HOSR Ls Related U.S. Application Data Sst (60) Provisional application No. 62/570,124, filed on Oct. (Continued) a FOREIGN PATENT DOCUMENTS (Si) Ime.c. , ea oo MOR A RDO nn GHB 3306 sic 900 (200601) Primary Examiner — Wale Lind, 4o1n S00 (200601) Assistant Examiner — Fredric Wendeoth ‘33y 8000 01501) (14) Attorney, Agen, or Firm — Woods Rogers A61C 1976 (2006001) Vandeventer Beek PLC: Nation A. Evans (Continued) (52) US.CL (7) ABSTRACT crc B29C 64/386 (2017.08), 461B 5/682 A computationally-designed instrumented intra-oral appli- (2013.01), A6IC 9/04 (2013.01); AGIC ance to optimize the location and coupling of seasors to ‘970046 (2013.01), ABIC 9/0053 (2013.01); optimize data integrity while maximizing comfort for the -AGIC 19/066 (2013.01); A63B 7I/8S eater. (2013.01); B33Y 1a (2014.12), B33Y S000 (2014.12), B33¥ 80/00 (2014.12): GO6F 30/17 13 Claims, 4 Drawing Sheets 4018 a0 Exemplary rip fayesthermoformed of 1S ma Bioerydspichng the fossion of te electrons gromieties in es for sample 2 (A and sample 3 (B), US 11,760,026 B2 Page 2 (51) Inch. B33Y 1000 (01501) BBY 5000 (201501) AGB 108 (2006.01), GO6F 3017 (2020.01), Goer 70 (2017.01) AGB 5/0205 (2006.01), A61C 13/00 (2006.01), (56) References Cited US. PATENT DOCUMENTS. 20100098270 AL* 42010 boll co 20170099208 A1* 42017 Sve, Je AGIB Si682 201WO26I737 AL* 92018 Simmonds Gist i060 DOIDURSSTSS AL 122019 Shivapaia BIC 71002 ® cited by examiner US. Patent Sep. 19, 2023 Sheet 1 of 4 US 11,760,026 B2 Figure 1: 3Shape Trios intra-oral scanning pod. US. Patent Sep. 19, 2023 Sheet 2 of 4 US 11,760,026 B2 2020 2010 2030 Figure 2: Three electronics geometries including the battery (A), the main cirenit board (B), and the power circuit board (C). US. Patent Sep. 19, 2023 Sheet 3 of 4 US 11,760,026 B2 3010 3020 Figure 3: Sample 1 with the rigid 3D printed layer and electronics geometries (3010) and the completed sample with trimmed EVA (3020). US. Patent Sep. 19, 2023 Sheet 4 of 4 US 11,760,026 B2 4010 4020 Figure 4; Exemplary rigid layers thermoformed of 1.5 mm Bioeryl depicting the location of the electronics geometries in grey for sample 2 (A) and sample 3 (B). US 11,760,026 B2 1 INSTRUMENTED INTRA-ORAL APPLIANCE COMPUTATIONALLY DESIGNED FOR OPTIMIZED FITTING AND FUNCTIONALITY (CROSS-REFERENCE TO RELATED APPLICATION ‘The preseat application relies on the disclosures of and claims priority to and the benefit ofthe filing date of US. Provisional Application No. 62/570,124, fled Oct. 10,2017 ‘The disclosures of that application are hereby incorporated by reference herein in thir entireties BACKGROUND Field ofthe Invention ‘The present invention is directed to @ custom instru- ‘mented intra-oral appliance that is designed 10 increase ‘compliance by the wearer tis also designed such that the sensor locations are optimized to accurately record humaa performance data or health metres, ineloding but not imited to, blood oxygen level, beat rate, head kinematics, et. In ‘one embodiment, sensors are strategically placed in optimal location(s) to record andlor evaluate head kinematies expe- rienced during impact events, with an emphasis on avoiding recording false positives. ‘In another embodiment, a near infared sensor is located ‘over or near a supertical artery to record heart rate, blood ‘oxygen level, blood osmolality, blood glucose, ete. with an ‘emphasis on mitigating data anifcts caused by human ‘motion and ambient light interference. In one aspect, heart rate and aetvity data from one or more sensor in oF on the ‘oral appliance may be combined with known wearer phy ‘logic metrics, including height, weight, gender, age, and ‘ethnicity, in order to determine accurate caloric expenditure. In one embodiment, an activity sensor could be added to ‘monitor motion ofthe wearer. The combination of the near infrared and activity sensors could be used to monitor sleep andthe effectiveness ofthe designed appliance In another embodiment, sensors are located to record the flow and quality of gases being inhaled into andor exhaled from the body with an emphasis on minimizing the resi tance of flow or generating turbulent flow that induces measurement errors. In one embodiment, the ae flow sensor ‘could be combined with nea infrared and activity seasors to create an at home sloop test In another embodiment, the sensors are strain gauges that are located ina retainer or ohodanti aligner in locations of the device that apply forces on the teeth to quantify the cluration and magnitude ofthe reaction forces on the device. In another embodiment, rigid electronic components are located based on size and shape compared to the wearer's ‘unigue teeth and mouth geometry in order to increase comfort and enhance the accuracy of recording desired ‘parameters, and the electrical connections hetwoen the elee- Ironic components sre accomplished using a flexible, con- ductive material that can be manufactured within the appl ance 10 allow electronics to be placed at unique distances ‘and locations from one another depending on the confign- ration or shape ofeach particular wearer's particular device. In another embodiment ofthe present invention, an intra coral appliance is provided that is designed utilizing. an intraoral sean of the wearer where the intraoral sean provides data that facilitates designing the device in com- putational space. x0 ” 4s © 2 In one embodiment, the data from the intra-oral scan is used to design a comfartable appliance that avoids contact ing sensitive areas inching those affected by gum disease, In another embodiment, the data from the intra-oral scan is, used (0 identify surface geometry that best matches the sensors and electronics to be placed into the appliance. In ‘another embodiment, the data from the intra-oral sean are used to define optimal contact areas for securing the device in place. Additonaly, this could be used to minimize the volume or surface area ofthe device while maintaiing an acceptable level of device retention. In another embodiment of the present invention, an intra- coral appliance is provided that is designed utilizing. an extraoral scan of a dental model of the wearer where the extraoral sean provides data that facilitates designing the ‘device in computational space, “The present invention is directed to a custom intra-oral appliance that is designed and optimizes! computationally. ‘The design of a general device could be optimized using scans fom the target population for the device using a statistical shape analysis (SSA), Further, each device could be designed specifically for individual users based on a general instrumentation design defined by the SSA and a best fit to the individual anatomy In another embodiment of the present inveation, a method for making an intra-oral appliance is provided whereby the custom intra-oral appliance is builtin part or in whole using 3D printing. In another embodiment ofthe present inven tion, @ method for locating and orientaing the sensors with, respect to the head center of gravity is taught using 3D data {rom an intra-oral scan and a surface sean, a sill image, or ‘nother form of imaging such as X-ray of CT Scan, Description ofthe Related Art A search fora comfortable, accurate, and commercally- {easible apparatus to record traumatic head events and other biological and physical occumences has resulted in aumet- us attempts. All references disclosed herein are incorpo rated by reference US. Pat, No. $,978,972, for example, describes an accel- cration-monitoring device comprising an aray of onthogo- ral accelerometers It cloes not deseribe an intra-oral appli= nee, nor does it describe any design considerations for data integrity USS. Pat, No. 6,826,509 describes the monitoring of a body part using a plurality of sensors adjacent to the outer surface of the body part with sensing axes orthogonal tothe outer surface. It does not deseribe an intra-oral appliance, ror does it describe any design considerations for data integrity US. Pat. No, 6,941,952 describes a sensing mouthpiece with atleast one linear force sensor for sensing impact forces fm the head of the user. It furher describes the mouthpiece to have @ mouth guard and sensors located on the hard palate, It does not deseribe where on the hard palate these sensors would be located, nor does it deseribe how sensors could be located on the hard palate without covering Hingual surfaces and diminishing the wearer’ ability to communi- cate. The curent invention does not have sensors or any other components in the hard palate area ofthe oral appli= ance, US. Pat. No. 8,930,144 deseribes an apparatus for mea suring acceleration ofa person's head comprising a sensor ‘and control unit that determines whether or not to enable recording based on the elation of the measured acceleration tnd a risk of an acute injury. In aspects of the cument US 11,760,026 B2 ES invention, an aceclerometer itself contain filters, ADC, ‘comparators, and interrupt; a contoller is aslocp, and an accelerometer interapt Wakes the contoller which saves data to non-volatile memory based on the aceleraton being identified as an impact exposure including injurious and. ‘noa-injurious events, US. Pat, No. 9,354,447 deserbes a head! mounted infor- ‘mation system comprising a sensor unit including a gyro- Scope and configuted to measure jump or fght time metrics. 11 does not deseribe an intra-oral appliance, nor does it deseribe any design considerations for data inter US. Patent Application Publication No, 20110184319 dleseribes an insirumented! mouthguard with at leat to sensors and a processor that detemnines ifthe mouthguard is in place using data from one sensor and determining the direction and magnitude ofthe impo from the other sensor It does not consider that a minimum of two sensors are required to measure the 6D kinematics ofthe bead, nor does, it describe a process of designing or locating the sensors to improve data integrity: US. Pat. No, 8,291,912 describes a method for manufac ‘uring oral-based hearing aids which can be designed based. ‘om intra-oral scans and manufactured using 3D printing, Is disclosure i speific to hearing aids, and describes locating the vibrating transducer in contact with @ toh. Itdoes not 28 describe an addtional optimization ofthe sensor location or device dimensions to improve data integrity and user com- fort Guard Labs (htpsliwww guardlah.com/pages/about-s) creates custom fred mouthguards using an intra-oral scan- ner to collect the wearer's dentition data, then 3D printing is used to create @ model ofthe dentition, andthe appliance is ‘hermoformed to the 3D printed model. This company does not include aay seasors, electronics, oF instrumentation in the devices, ss US. Patent Application Publication No, 2017/0156635 dlscribes an instrumented mouthguaed that is designed such that the sensors are near the front of the mouthguand and siandofl is generated between the molars to isolate the Sensors and mitigate noise yenerated in sensor data fom ‘eth chatter. This application is generalized design to be applied to all wearers of the device and implements a long-standing desiga criteria of isolating sensors from nose 11 does not however apply this technigue in a unique or individual method that would optimize data integrity for ‘each user and consider comfon, Adding material t0 the ‘occlusal surface of the molars cou! decrease comfort far ‘wearers, and reduce wearer compliance US. Patent Application Publication No, 201710095204 ‘Al describes an instrumented orl appliance which s rigidly ‘coupled to the bony portions of the upper jae comprising & rigid central component and sensor. ‘The application describes obtaining the wearer's dentition data using a negative mold rather than an intraoral sean. Aso, the application describes only that the sensors be centrally located as an assumption that this is where they will be located forall wearers. x0 ” 4s 0 SUMMARY, ‘The present invention isan instrumented intra-oral appl ance which is computationally designed to optimize the ‘comfort for the wearer as well asthe location of sensors to maximize data integrity. This ean include the design of a ‘generalized electronics package that will it the majority of the targot population based on a statistical shape analysis. “The intra-oral appliance can also be customized for each 4 individual using data collected with an intra-oral sean. The Avice ean also be optimized using finite element analysis. Finally, the device ean be manufactured in part or in whole by 3D printing “The geometry of each person's mouth is unique. In one embodiment, the invention herein teaches an instemented intra-oral appliance, which is optimized to inerease compli- ance, meanilg wearing the appliance, while also enkancing the location of sensors to rovord an event (eg. traumatic hhead impact, or biological sign (e., blood oxygen level), or environmental conditions (eg, amount of carbon mon oxide inhaled). Because te interior ofthe mouth i sensitive tw contact, an intra-oral appliance that aecounts for mouth geometry to determine where to place certain sensors is needed, The invention described herein teaches a way to ‘computationally optimize the placement of the sensors so that the appliance does not initate the user. Moreover, because some areas of the mouth are more aivantagoous to place certain sensors (eg. 4 near infrared sensor to record heart rate is best located near a superficial artery), an appliance is taught with such sensors located where they will best perform their functions as determined based on, for example, an intra-oral scan, ast aitempis have taken a one-size-fis-all approach and the result is Tack of pationt compliance—for example a football player will not wear an instrumented mouth guard that is uncomfortable. Other approaches that have endesv- red to make a unigue appliance based on the user's dental geometry have not accounted for how differences will affect, ‘optimal locations for sensors. The present invention teaches way to make an intra-oral appliance that resolves the shortcomings of the prior art, by creating an intra-oral ‘appliance tat is then computationally analyzed to optimize placement of sensors to increase both user comfort and aeuracy of recordings by the sensors. BRIEF DESCRIPTION OF THE DRAWINGS ‘The accompanying drawings illustate certain aspects of | some of the embodiments of the present invention, and should not be used to limit o define the invention. Together with the written description the drawings serve to explain certain principles of the invention. FIG. 1 isa picture of a 3Shape Tos intra-oral scanning FIG, 2 is a diagram of a bottom portion of aa intra-oral appliance according the invention deserited herein, showing the location of certain electronic components FIG, 3 are pictures of embodiments of the present inven tion showing electronic goometies bonded toa layer ofthe sample and the completed sample with the electronics embedded between layers. FIG, 4 are pictures of embodiments of the present inven tion showing electronic geometies and completed samples. DETAILED DESCRIPTION OF VARIOUS. EMBODIMENTS OF THE INVENTION ‘The present invention has been described with reference ‘© paricular embodiments having various features. I will be apparent o those skilld in the art that various mosiications and variations can be made in the practice ofthe present invention without departing from the scope or spirit ofthe invention. One skilled in the art will recognize that these ‘eatures may be used singularly or in aay combination based ‘on the requirements and specifications ofa given application or design. Embodiments comprising various Features may US 11,760,026 B2 5 also consist of or consist essentially of those various fea- tures. Other embodiments of the invention will be apparent to those skilled in the art from consideration ofthe speci- fication and practice ofthe invention. The description ofthe inveation provided is merely exemplary in nature and, thus, ‘variations that do not depart from the essence of the inven= tion are intended to be within the seope ofthe invention, All references cited in this specification are hereby incorporated bby reference in their entireties Embodiments ofthe invention also include a computer readable medium comprising one or more computer files comprising a set of computer-executable instructions for performing one or more of the calculations, steps, processes and operations described and/or depicted herein, In exem- plary embodiments, te files may be stored contiguously or ‘hoa-contiguously on the computer-readable medium, Embodiments may include a computer program product ‘comprising the computer files, either in the form of the ccomputerreadable medium comprising the computer files 2 and, optionally, made available to & consumer through packaging, or altematively made available to a consumer through electronic distribution. As used inthe context ofthis, specification, a “computer zeadable medium” isa non-iran- sitory computerreadable medium and includes any kind of ‘computer memory suchas floppy disks, conventional hard disks, CD-ROM, Flash ROM, non-volatile ROM, electri- cally” erasable programmable read-only memory (EE~ PROM), and RAM. In exemplary embodiments, the com- puter readable medium has a set of instructions stored thereon which, when executed by a processor, cause the processor to perform tasks, based on data stored in the ‘electronic database or memory deseribed lecin. The pro- cessor may implement this process though any of the procedures discussed in thie disclosure of through any ‘equivalent procedue, In other embodiments ofthe invention, files comprising the set of computer-exccutable instructions may be stored in ‘computer-readable memory on a single computer or distrib- ‘uted across multiple computers. A skilled artisan will further appreciate, in light of this disclosure, how the invention can be implemented, in dition to software, using hardware or firmware, As such, as used herein, the operations of the invention can be implemented in a system comprising a ‘combination of software, hardware, or firmware. Embodiments of this disclosure include one or more computers or devices loaded with a set of the computer- ‘executable instructions described herein, The computers or devices may be a general purpose computer, a speci purpose computer, or other programmable data processing apparatus to produce a particular machine, such that the one ‘oF more computers or devices are instructed and configured to carry out the calculations, processes, steps, operations, algorithms, statistical methods, formulas, or computational routines of this disclosure. The computer or device perform- ing the specified calculations, processes, steps, operations, algorithms, statistical methods, formulas, or computational routines of this dselosure may comprise at east one pro cessing clement such as a central processing unit (ie. processor) and a form of computer-readable memory which may include random-aecess memory (RAM) or read-only memory (ROM). The computer-executableinsietions ean be embedded in computer hardware or stored in the com- pputer-readable memory such that the computer or device nay be directed to perform one or more ofthe calculations, steps, processes and operations depicted andlor described herein. ” 4s © 6 Additional embodiments of this disclosure comprise a computer system for carrying out the computer-imple- ‘mented method ofthis disclosure. The computer system may comprise a processor for executing the computer-executable instructions, oe or more electronic databases containing the data or information described herein, an inpuvoutputinter- {ace or user interface, and ast of instructions (e-. software) for carrying out the method. The computer system can include a stand-alone compute, such as a desktop computer, 4 portable computer, such as a tablet, laptop, PDA, or smartphone, or a set of computers coanected through a network including a client-server configuration and one or more database servers, The network may use aay’ suitable network protocol, incding 1P, UDP, or ICMP, and may be ‘any suitable wired of wireless network ineluding any’ local areanetwork, wide area network, Intemet network, telovom- ‘munications network, Wi-Fi enabled network, or Bluetooth enabled network. In ane embodiment, the compute system comprises a central computer connected to the internet that has the computer-executable instructions stored in memory that is operably connected to an internal electronic database. “The ceatral computer may perform the computerimple- ‘mented method basod on input and commands received from remote computers through the intemet. The central com puter may effectively serve as a server and the remote computers may serve as client computers such that the server-clent relationship is established, and th client com puters sve queries or receive output fom the server over a network. The inpuvoutput interfaces may inchude graphical user interface (GUN) which may be used in conjunction withthe computer-executable code and electronic databases. The graphical user interface may allow a user to perform these tasks through the use of text feds, chock boxes, pull-downs,, command buttons, and the lke. skilled artisan will appre- ciate haw such graphical features may be implemented for performing the tasks of ths disclosure. The user interface ‘may optionally he acessible through a computer connected to the interme, In one embodiment, the user interface is aceessible by typing in an internet address through an industry standard web browser and logging intoa web page. “The user interface may then be operated through a remote computer (cient computer) accessing the web page and transmitting queries or receiving output from a server through a network connection, -efore explaining atleast one embodiment of the inven tion in detail, itis to be understood that the invention is not, Jimited in its application tothe details of constriction and the arrangement ofthe componeats set forth in the following description or illustrated in the drawings, The invention is capable of other embodiments or of being practiced or carried out in various ways. Also, itis to be understood that, the phraseology and teminology employed herein s forthe purpose of description and should not be regarded as lim iting, ‘The instrumented intra-oral appliance is designed com- putationally to optimize the location of sensors to maximize ‘ata quality of head kinematies experienced during impaet ‘events. The sensors are rigidly couple tothe human head to ensue that they measure the kinematies of the bead. Als, the lower mandible can interact with the upper jaw which ‘ean cause noise or false events in inertial sensors designed to measure kinematics. The location of the sensors with respect to the lower jaw minimizes noise and false positives created by the upper and lower teeth interacting, Also, the sensors are located within layers ofan intra-oral appliance ith differing material properties to minimize noise, such 2s US 11,760,026 B2 7 hardness, stiffness, flexural modulus, tensile modulus, and! ‘or tensile strength. These layers are designed such that they hhave mechanical damping properties that act as alow pass filter 1 reduce noise and charter from the upper and lower teeth interacting. The sensors can also be located in prox imity to anatomical surfaces with larger ato nearly la surfaces to control the thickness of layers and mechanical damping properties of the appliance. In another embosiment, the seasor may comprise @ pho- topletiysmogram (PPG) or near inated (NIR) sensor that is located to minimize noise generated by bumsan motion and ambient Fight. PPG and NIR sensors noed to be placed in close proximity to the body surface and specifically an area with superficial arteries to maximize signal quality. Addi tionally, NIR and PPG sensors are subject 10 noise from ambient light, and the sensors, according to the present invention, are placed in an intra-oral appliance such that they are located on a surface that does not have exposure t0 ambient light during typical use. The device can further be designed such thatthe seasor i pushed against the body’ and the appliance ereates a seal around it blocking out ambient light, The surface of the appliance in contact may’ also be

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