The present invention is in the field of dual-purpose orthodontic appliances for simultaneously treating sleep apnea and straightening the teeth (desired movement of teeth) or reducing bruxism (teeth grinding) or reducing TMJ using smart sensors and smart sensors connected to a microprocessor/control module system having the capability of wireless communication. Teeth trays are defined as “aligners” or “bite splint” or “night guard” or “mouthguard”. The appliance has one or several sensors mounted at specific locations inside the mouth on teeth trays and or externally on detachable housing which is connected to teeth trays. There are different types of sensors such as physical sensors, chemical sensors, biosensors, positional sensors, accelerometers, gyroscope, pressure sensors, touch sensors, pulse oximeter, temperature sensors are attached at difference location of the appliance depending on the function(s) desired to treat sleep apnea and for aligning the teeth or reducing the bruxism or teeth grinding. The smart sensors are mounted on control module or and are connected to control module system. The present invention is also in the field of a computer aided design procedure for preparing a customized teeth trays designs, software, and control module with microprocessor having flash drive and manufacturing technologies of orthodontic appliances. The appliance is manufactured by 3D printings (additive manufacturing) technologies or other plastics manufacturing technologies.
The subject matter is directed to orthodontia, and specifically to 3D printing technologies applied to direct manufacture of orthodontic aligners for straightening teeth with innovative anchors to be placed on the teeth in conjunction with the aligners. The subject matter is also directed to aligner designs, materials, 3D support structures and finishes to be used in additive manufacturing processes for making the orthodontic aligners and anchors. The subject matter is also directed to additive manufacturing processes for making complex and very thin aligner designs. Modified aligners for correcting bite or as a splint to treat temporomandibular disorder (TMD) or to treat sleep apnea with or without mandibular advancement or as a functional appliance to promote growth of the lower jaw are also described.
Currently, there are two main systems in the market for correcting the position of teeth. The first system is a braces scenario that may include traditional self-ligating orthodontic brackets with a steel tight bracket, a straight wire application, or a traditional Tweed appliance. The second system is a clear aligner system, in which aligners are interchangeable by the patient during treatment. The clinician may prescribe a series of aligners, which are generally placed over, but are not themselves adhesively secured or otherwise attached to, the patient's teeth, to move one or more teeth from their original position to their aesthetically pleasing or functionally corrected position. Typically, a series of aligners is required to fully treat the patient because the degree of movement produced by a given single aligner is limited. One such aligner system is the INVISALIGN aligner system (Align Technology, Inc., San Jose, Calif.). Each aligner is responsible for moving the teeth toward their final pre-determined or aesthetically/functionally correct position.
The INVISALIGN aligners are fabricated by physical and computer-aided molding processes. The conventional process begins by taking an impression of the patent's dentition, or using intra-oral scanner for teeth impression, followed by creating a denture model of the teeth on computer. This CAD file, for example an .STL file, is used to 3D-print the physical teeth models and molds. Finally, clear plastic which will form the aligner, such as a polyurethane, is molded (e.g., thermoformed) over the physical teeth model or mold of the tooth configuration to be implemented. Subsequent physical steps of the conventional process trim the molded aligner to remove sharp edges or portions which might contact and irritate the gingiva. In addition, the aligner surface and edges are typically smoothed via a process such as tumbling.
This conventional fabrication of aligners is a tedious process, which compounds both cost and time of treatment for the patient. Since such an orthodontic treatment may require, for example, 25 intermediate reset molds to represent 25 stages of treatment progress, the cost and time required for the necessary steps of mold making, aligner formation, and trimming, may be prohibitively high. The cost is additive, as each new stage in treatment or each change in treatment requires the production of a new mold. Likewise, the cost of storing a series of molds for each patient throughout treatment may be formidable. U.S. Pat. No. 5,975,893 to Align Technologies, Inc., is incorporated by reference herein in its entirety, to describe the processes elaborated above, as background information.
Treatment of malocclusion by aligners faces challenges other than the difficulty of manufacture. Specifically, aligners fastened with attachments may prove very difficult to install, as a result of the limited number of shapes that the attachment apertures on the aligner may take, consistent with the INVISALIGN manufacturing process. Specifically, the attachment apertures are formed by thermoforming over a stereolithographically-generated positive tooth model, which limits the type of apertures that may be made. Moreover, aligners may bind with the attachments and prove very difficult to remove. Furthermore, in many aligner patients, the presence of the aligner within the patient's mouth causes a change in the points of occlusion between the mandible and maxilla, and in particular, causes the guidance of occlusion to move to the rear molars. This opens the patient's bite and typically intrudes the rear molars as a consequence of the unbalanced occlusion force on the rear molars.
One result of this conventional unbalanced occlusion force can be TMJ injury after the removal of the aligner, because the force of the mandible is no longer resisted by the rear molars in the absence of the aligners. For many patients aligners fabricated manually or by thermoforming on a positive model are uncomfortable and can irritate the patient's gingiva and/or tongue to such an extent that the soft tissue becomes inflamed and can potentially bleed. This discomfort is generally caused because the aligner is trimmed inaccurately to the patient's gingival margin. The inaccuracy in trimming is generally caused by the minimum size of the trimming tool particularly on the anterior lingual side where the aligner interferes with the tongue. Other anatomy such as the incisive papilla, if not generally considered when trimming the aligner, can cause swelling or inflammation. In addition, the location where the aligner is trimmed can cause a sharp flange to be created at the base of the aligner near the gingival margin, particularly on the lingual side.
Due to disadvantages of thermoforming and to reduce the steps involved in conventional aligner manufacturing methods, as well as aligner design limitation of thermoforming process, an alternative method is needed to manufacture an aligner to configure better to the counters of the teeth and to provide better finishing of the appliance. This would reduce the inaccuracy of each step to provide better adaptation, better fit, and better finish.
An ideal alternative apparatus and methodology for realizing aligners configured to correspond to a series tooth configuration should be economical, reusable, reduce time consumption, reduce material waste, and in particular, should reduce the need for fabricating multiple casts of teeth arrangements for various stages in the orthodontic treatment.
Obstructive sleep apnea (OSA) is a sleep disorder with partial or complete cessation of breathing during one's sleep. This sleep disorder is currently treated by methods such as a surgery, oral appliance therapy, negative pressure to pull soft palate and tongue forward, implantable devices that keep the airway open during sleep by stimulating the hypoglossal nerve, strips for the nose for expiratory positive airway pressure, Positive Air Pressure (PAP) therapy, or a combination involving several methods. PAP therapies are also employed to treat other medical and respiratory disorders, such as Cheynes-Stokes respiration, congestive heart failure, and stroke. A common PAP device comprises a flow generator (e.g., a blower) that delivers gas via delivery conduit (hollow tube) to an individual interface. It is also known to deliver the PAP as a continuous positive airway pressure (CPAP), a variable airway pressure, such as bi-level pressure (Bi-PAP) that varies with the individual's respiratory cycle or an auto-titrating pressure (APAP) that varies with the monitored condition of the individual. Nasal, oral-nasal, and full-face masks are common interfaces utilized for delivering PAP to the individual's airway.
These masks can be uncomfortable due to improper fit, tight straps to hold mask in place, skin irritation at points of contact, dryness of throat, the feelings of claustrophobia, and excessive PAP pressure are major factors in individual therapy non-compliance. Also, the PAP machines can be noisy. Studies show individual compliance for PAP therapy is less than 50%. For patients who cannot tolerate CPAP machine therapy, oral appliance therapy is an effective treatment option for snoring and obstructive sleep apnea (OSA). A custom-fit oral sleep appliance known as a mandibular advancement device (MAD), can be effective for people who cannot tolerate CPAP devices. Worn only during sleep, an MAD oral appliance fits like a sports mouth guard or an orthodontic retainer. It supports the jaw in a forward position to help maintain an open upper airway. The devices snap over the upper and lower dental arches and have several designs/concepts for the lower jaw to be eased forward. Some, devices allow patient to control the degree of advancement. But there is no device on the market for children as well as adults to treat sleep apnea while they are going through the process of straightening teeth with aligners, except the combination of conventional aligners with conventional PAP devices, which is not a comfortable combination. Most importantly, treating both conditions is an advantage in preparation for definitive treatment with orthognathic surgery Gaw surgery).
Overview
This disclosure describes direct 3D-printed orthodontic aligners with example torque, rotation, and full-control anchors, including systems, methods, and materials and support structures for manufacturing 3D-printed orthodontic appliances such as aligners, and also anchors, including novel “orthodontic divot anchors” (hereinafter, “divot anchors”). An example system can use divot anchors for correcting the rotation and torque control of anterior teeth, and for three-dimensional control of teeth in general.
An example process applies direct 3D-printing or additive manufacturing to create aligners and divot anchors that apply the design and mechanics concepts described herein. Example 3D-printing processes use medical-grade and medically approved materials, for example 3D-printable materials that are elastic in nature, to exert comfortable forces when a patient wears the 3D-printed aligners. Upon exertion of force, an example aligner may extend or stretch but then returns to original position to exert constant force, assisting in the programmatic movement of teeth. An example 3D-printing process prints thin, variable-thickness, hard, and hard-soft aligners, as well as aligners that may have different properties at different places or sections on the aligner, 3D-printing, for example, in a single step using an FDM process, an SLS process, a direct pellets fused deposition process, SLA, multi-jet photo cured polymer processes, HP Multi Jet Fusion technology, continuous liquid interface production technology (CLIP), and other 3D-printing processes.
The example systems and processes described herein provide unique anchoring designs on teeth, which work in conjunction with aligners and other hardware for improved tooth movement with less discomfort, reduced time of treatment, and easy placement and removal of the 3D-printed aligners and devices.
Currently, in the case of aligners, there are two main systems in the market for correcting the position of teeth. The first system is a braces scenario that may include traditional self-ligating orthodontic brackets with a steel tight bracket, a straight wire application, or a traditional Tweed appliance. The second system is a clear aligner system, in which aligners are interchangeable by the patient during treatment. There is no directly 3D printed aligner technology available in the market except the Applicant's own technology. Also, there are no directly 3D printable bite splints or nightguards to treat bruxism available in the market except the Applicant's technology. In this description, teeth trays are also called aligners or bite retainers or nightguards.
This description describes several concepts of treating sleep apnea and having sensors with a control module only on the teeth trays and or on both teeth trays and external housings. Various embodiments provide electric stimulation of the tongue and/or air stimulation of the tongue to keep the tongue relaxed, not allowing the tongue to fall back during sleep, thereby treating sleep apnea. The description also provides position control training to reduce episodes of sleep apnea.
Example Systems
The following paragraphs describe various embodiments of the subject matter. The subject matter is not intended to be limited by specific examples, and those skilled in the art can apply the principles described in ways not specifically disclosed, while remaining within the scope of the subject matter described.
In an implementation, an example system provides new orthodontic anchors, referred to herein as “divot anchors” for correcting the rotation and torque control of anterior teeth, and also three-dimensional control of teeth in general. The example divot anchors and 3D-printed aligners work in cooperation with each other to provide better and faster orthodontic realignment of teeth.
Example systems that directly 3D-print aligners and divot anchors use medically approved, orthodontic grade materials having, for example, elasticity by nature. These can exert comfortable force when worn by the patient. Upon exertion of a force the aligner may extend or stretch but returns to its original position to exert a constant force for effecting programmed teeth movement.
Example Divot Anchors
Example Full Control Anchors
Example anchors can provide three-dimensional control for realignment of misaligned teeth. Current conventional designs of the INVISALIGN aligner cannot have three-dimensional control of the teeth due to their manufacturing methods and design limitations.
In an implementation, an example aligner is based on principles of the Andrews' straight-wire appliance. The principles provide three-dimensional control of misaligned teeth (straitening the teeth) with removable, directly 3D-printed (additive manufactured) plastic aligners utilizing anchor points as described below. The benefits compared with conventional braces with wires are: easily removal, ease of cleaning, more predictable alignment, and easier tasking by the orthodontist.
In an implementation, each tooth has a specific position in the arch and a relative position to the neighboring teeth. Each tooth can have a reference point on it, on the buccal or lingual surface, and when aligned makes the teeth come into alignment in three-dimensional space. This point is referred to as FA (Facial Axial) point by Dr. Andrews, as shown in
In an implementation, the following are steps for placing anchors on teeth:
1. First align the teeth digitally to their final position in a computer model or virtual model.
2. Calculate anchor points to be placed on each tooth or necessary teeth to be moved at the predetermined point FA point or a point in relation to this point consistent on all the teeth, digitally.
3. Determine each anchor point to have a movement prescription in angulation, rotation, and torque and a buccolingual position built into it, as determined by final position of teeth on a digital or virtual teeth modeling set-up.
4. Once anchor points are determined on digital teeth, the anchors can be transferred to mouth teeth using an aligner transfer tray.
Example Force System
An example approach for forces to be delivered by a removable plastic aligner is described. The approach starts with light forces applied to enable engaging the anchors to a first level of force, and to initiate alignment of teeth for progressing gradually (as treatment progresses, then the next series of aligners), then to an aligner that is rigid enough to applying correcting torque to the teeth. Retraction and space closure can be done simultaneously or in stages.
Forces are generated by gradually increasing the stiffness of aligners (from soft initial aligners to rigid aligners as treatment progresses). This concept is only possible by use of different materials and direct 3D-printing, as conventional plastic-working processes will not be able to make an aligner with different dimensions within the same aligner, or different pre-defined thicknesses within the same aligner; or soft/hard materials at variable thicknesses at pre-defined locations within the same aligner.
Properties of the 3D-printed plastic aligner materials need to be consistent with the following metal arch wire parameters to produce force levels of around 26 gm/cm2 of root surface: 0.014 nitinol (0.014-inch diameter) or 0.018 nitinol (0.018 inch diameter) or 18×25 nitinol (rectangular) or 18×25 steel (rectangular).
These values can be achieved by addressing the modulus of elasticity of the plastic aligner material, selecting the correct force deflection curve of plastic aligner materials to match metal arch wires, controlling the thickness of the aligner, the cross-section of the aligner, and the engagement of the aligner in the anchors.
Due to 3D-printing processes, aligners are designed with smooth edges so aligner does not irritate the patient's gingiva and/or tongue, so soft tissues do not become inflamed or blend. The process also allows no sharp flange at the base of aligner near the gingival margin particularly on the lingual side, as no trimming operation is required, but which is the part of the conventional aligner manufacturing process (i.e., thermoforming of plastic film, followed by trimming, cutting, deburring, and a smoothing operation, etc.)
Some of the example divot anchor designs described herein can also be used in conventional manufacturing of aligners, i.e.; thermoforming a plastic sheet/film on 3D-printed dental model or conventional dental model, where a simple design of a divot anchor is sufficient, or other reasons decided by the dentist or orthodontist.
The example designs, compositions, and geometries of the example 3D-printed aligners are an important part of example orthodontia systems, particularly the anchoring design of the aligners, to move teeth at pre-designed positions and apply force at predefined locations on a tooth. So the design of example aligners based on anchor design is significant since the aligner has to fit on the divot anchor and the two components have to work in conjunction with each other, as well as the aligners have to be manufacturable by 3D-printing processes.
Other example design innovations, materials, and processes are described below.
Specific additive manufacturing processes, or 3D-printing technologies with specific support structure during 3D printing, may be specifically required for particular aligner designs. Likewise, specific material formulations and combinations may be called for. The direct 3D-printing of aligners resolves several issues facing current conventional manufacturing methods. Example processes can direct 3D-print an aligner with thin or thick parts, an aligner having variable thicknesses at desired locations, hard or hard/soft aligners, aligner with different properties at different locations by design, or by using different materials within an aligner in a single step using 3D-printing processes such as FDM process, SLS process, direct pellets fused deposition process, DLP process, SLA, multi-jet photo cured polymer processes, HP Multi Jet Fusion Technology, the CLIP process, etc.
The aligner which fits on above concept designs can be made of single material with variable thicknesses at desired location to achieve desired tooth movement (i.e., differentially increase the thickness to change the amount of force with same material). Or, an example process may exert force regionally with changing thickness, incorporating a design concept or by changing material within the aligner.
An example 3D-printed aligner may exert a more effective force with better control of manufacturing and may have controlled thickness of the aligner in desired areas to exert forces needed to perform tooth movement in the desired direction based on size, root length, and surrounding bond support. This can reduce number of aligners needed for orthodontic treatment of the teeth.
Aligner can also be made of multi-materials with or without variable thicknesses at desired locations. Multi-materials can help to change the position of the vertical plane. One of the inventions is to alter the shape and structure of plastics to exert force regionally, by torqueing or pushing the teeth up.
The invention also includes use of multi-materials in the aligner layer-by-layer through thickness in vertical position or horizontal position during same cycle of manufacturing.
One example aligner design uses different modulus of elasticity materials for teeth at the front (front teeth) and back part (back teeth) of the patient's arch. Another aligner covers the teeth at different levels (height). In an implementation, hard and soft aligners are 3D-printed separately, bonded together, or hard and soft are printed in the same 3D-printing step on top of each other.
In an example process, the properties of an aligner (as a whole or at desired localized area) are modified after manufacture by exposing the aligner or its parts to different energy sources such as electron beam, microwave, UV light, LED curing light, etc.
An example aligner can be clear, white, or tooth colored, for example. White or tooth-colored aligners may allow the aligner to fill pontic spaces (missing teeth) by directly 3D-printing dummy teeth. The tooth-colored aligners can be made by adding pigments or color in the base plastics, or by painting or coating the aligner after it is manufactured by a 3D-printing process. One can also incorporate decorative or identification features. A polymeric medical grade coating can be applied after the aligner has been manufactured by some of the additive processes where it is desired to reduce surface porosity and improve surface smoothness. In an implementation, specific polymeric coatings with high molecular weight can be applied to increase the properties such as MOE after the example aligner is fabricated.
The invention shows how to cover the teeth at different levels, or some teeth, or leave an area not to be covered. The treatment can start with a series of aligners with hard followed by soft and so on. Three-dimensional control of misaligned teeth may start with a soft aligner.
One can have day and night appliances separately, where night appliance can have different thickness. It is also possible to adhesively join or ultrasonically weld 3D-printed hard and soft appliances to get a single aligner having hard/soft surface parts.
The patient should typically wear the aligner all the time except eating food or drinking hot liquid. Patient compliance is a major issue. One of the innovations is to incorporate die or pigment into plastic or coating of one of the molar internal teeth with this coating containing this dye or pigment. This die or pigment works as sensor, the color slowly goes away as time passes in the presence of mouth fluids (As color fades away, it indirectly tells patient or dentist the time duration aligner was in mouth). This may increase the compliance of wearing the aligner. If the patient is wearing the aligner as planned, and if dye fades away, it means that particular aligner has done its job, patient does not have to keep on wearing the aligner, it tells patient to switch to next aligner, which can significantly reduce treatment time for patient. Also, this dye concept can help dentist to determine if teeth movement is not occurring as planned. A micro-chip with small embedded sensors (such as temperature sensor) may also be included in an aligner to detect tooth movement over time and the compliance level of the patient.
An example aligner may incorporate a microchip on the aligner (inside at interface between aligner and tooth) with a force sensor that measures the forces that act on the tooth interface. The aim is to give feedback how well aligner is functioning, reduces the duration of therapy, related expenses and discomfort of individual as well as compliance information. A micro-sensor can be placed on a divot attachment to measure load/force values to see performance of the aligner as predicted by software and provide information remotely to orthodontist as well as patient.
An example aligner may have 3D-printed school logo or other design, or a very thin low modulus film with different designs which can be attached onto it for better appearance.
The aligner may function as sleep apnea or anti-snoring device by connecting the upper and lower aligners together and moving the lower jaw forward or making upper aligner with front hollow housing and side half round hollow tubes or center tube from the front housing which can bring more air while breathing, opening the air passage, reducing the snoring.
The aligner can also be used as mouth guard and night guards to prevent grinding of teeth.
The innovative material(s) and design of aligner is elastic in nature which means it exerts comfortable force when patient wears it and upon exert of force the aligner may extend/stretch but returns to original position to exert a gentle constant force to help programmed teeth movement. The material should not relax and lose energy in initial days of aligner wear. The thermoplastic material that exhibits substantial linear elastics behavior with a high yield point is more desirable. Creep, fatigue and dimensional stability properties of polymers are also important.
Proposed materials for thermoplastic 3D printing process are polyurethane (TPU), polyamide, polyester or co-polyester such as PETG, polycarbonate, PMMA, polypropylene, polyether sulfone (PES), PLA, Polyolefins etc. For thermoset 3D-printing processes such as SLA, DLP etc, photopolymer acrylic resins and epoxy/urethane resin can be used to achieve the desired material properties.
One of the materials that can be 3D-printed is self-reinforcing plastics. The benefit of this material that it does not have fibers, but the polymer itself helps in controlling the aligner's properties. This material has a high elastic modulus, no deformation after desired strain, toughness, and high strain at break.
The plastic powder particle size for SLS process is very important to have dense fusion. The particle size is in the range of 20-100 microns. Less than 50 microns is preferable. Bulk density of powder is in the range of 0.20 grams/cm3 to 0.40 grams/cm3 as per ASTM D1895. It is important that the aligner does not crack during finishing process. High polymer powder fusion characteristics is very important for powder 3D printing processes such as SLS and Multi-jet fusion One of the inventions is to combine different family of plastics/polymeric powders, hard and soft, (as an example—Polyamide (hard) with TPU—soft) having very close particle size distribution to obtain desired modulus of elasticity and more isotropic properties and softness of aligner where desired (same properties in X,Y and Z direction, which is difficult to achieve in case of SLS and multi-jet fusion process).
To achieve the above-mentioned design concepts using several 3D-printing processes, the innovative developed materials may have the following properties:
Tensile Modulus in the range of 1400 Mpa to 2000 Mpa (ASTM D638)
The orthodontic system may use a total digital or total virtual concept. The patient or orthodontist can take the digital impression using Nano intra-oral scanner, smart phone having attached extended camera or WiFi camera transferring the digital data to a smart phone or other device to create a .STL file of teeth. The camera may be independent of smart phone or other digital device (attached to phone by wire or wireless). Orthodontist or other dental professional can design series of aligners based on final desired teeth movement and can 3D print these aligners at his office during patient's first visit or can send .stl file to out-side service labs who 3D prints the aligners for orthodontist or dental professional. As teeth movement occurs, take digital impression again, make new aligners as described above or using available software, make series of aligners for certain amount of teeth movement before calling the patient back in office. This is less iterative, fast and low cost solution.
Above described total solution of innovations in design, innovation in materials and incremental process improvement open up lot of design freedom and options in treating the patient in short amount of time and certain non-feasible cases which are not possible now. It can be cost effective, more precise, and more comfortable to patient.
For FDM Process (Thermoplastics):
A new concept allows printing of different materials not only in X and Y direction but also in Z direction. Also using hybrid process, using robotic extruder heads it is possible to print multi-material during or after part is made.
The example system also includes use of single filament having two different molecular weight materials to get hard/soft aligner in a single step process. During 3D-printing, low molecular weight material which is soft comes on the surface. Or one can use two layer filament where outer layer is made of soft material. Inner layer is hard material of same polymer or different but compatible polymer. Or one can include additives which cures the polymer to higher molecular weight, after 3D printed FDM aligner is put in the microwave oven or exposed to other energy, increasing the strength in Z direction (without distorting the part
For Powder based processes—SLS (selective laser sintering) or Multi-jet Fusion—Thermoplastics:
To get a hard and a soft material in same part, mainly to get soft or hard material on the surface of the part, example material formulations may be used. The material consists of low and high molecular weight materials in powder form. After the part is made by laser sintering or multi-jet fusion, the part can be exposed to high temperature, just below the melting point of low molecular weight material, this causes the low molecular or soft material to come on the surface, building very thin layer of soft material on surface. SLS process uses laser, while Multi Jet Fusion which does not use lasers. Here, the powder bed is heated uniformly at the outset. A fusing agent is jetted where particles need to be selectively molten, and a detailing agent is jetted around the contours to improve part resolution. While lamps pass over the surface of the powder bed, the jetted material captures the heat and helps distribute it evenly.
One example technique increases the modulus of the aligner as a whole or localized area by crosslinking of part after it is made or during the part fabrication.
Another example process adds a specialty coating, which provides a smooth surface.
An example technique combines different families of plastics powders (such as Nylon with TPU) having very close particle size distribution to obtain desired modulus of elasticity and more isotropic properties (same properties in X,Y and Z direction, which is difficult to achieve in case of current SLS process)
For SLA process (Stereolithography)—Thermoset:
In SLA process, the aligner to be made is either pulled out of a vat containing liquid material as it is solidified by a light source through a translucent window at the bottom (bottom-up), or it is submerged into the liquid as the top layer is treated by a light source from the top (top-down).
First the part can be made from one material, mainly photopolymer. Then, this part is inserted in the liquid of different material where other material is cured on the surface of first part. The invention is to get part with different softness and also additional features with second material.
DLP, or digital light processing, is a similar process to stereolithography in that it is a 3D printing process that works with photopolymers. The major difference is the light source. DLP uses a more conventional light source, such as an arc lamp, with a liquid crystal display panel or a deformable mirror device (DMD), which is applied to the entire surface of the vat of photopolymer resin in a single pass, generally making it faster than SL.
For FDM process, to increase properties in Z direction, the crystallization kinetics of the material are changed to get better heat retention and hence higher inter-layer bonding between layers in Z layers. This invention is only applied to crystalline or semi-crystalline polymers. This concept can be used with dual layers filament having core-shell structure as shown in
To improve fusion properties and shrinkage properties of SLS or Multi-fusion materials, fillers like silica powder, glass microspheres etc., are added. To improve impact properties and reduce modulus of elasticity still applying constant force without aligner deformation, elastomers like TPE in rigid plastics like nylon can be added.
In another system, dual modulus material is used in the same part for SLA process, to get low modulus in certain area of the part, photopolymer is cured with laser beam with low frequency while rest of the part is cured with laser beam with high frequency to get an aligner with dual modulus with in the same part.
The various hardware described above, such as the example anchors and 3D-printed aligners, can be used to effect rotation for correcting tooth misalignment. As shown in
Currently with a conventional INVISALIGN aligner, correction of rotation is been achieved by a push rotation. As shown in
Thus, the INVISALIGN aligner and other aligner designs on the market are very inefficient, further adding to a problem that there is too much resistance on the contralateral side (opposite side), because the conventional aligner contacts with the tooth.
The following describes three example designs for improving rotation correction. First, in
Using the described hardware, an example technique applies a pull force on the one side (for example on buccal side—the surface of a posterior tooth facing the cheeks) with a defined point of application using the divot anchor on the tooth. Placement of the divot anchor is easier that conventional placement of a rotation device, as shown in
As also shown in
In a second example method for correcting rotation, the rotation control is achieved by creating a couple. As shown in
Another way to achieve this aim is to add a divot anchor on the lingual side also (the surface of a tooth facing the tongue). This scenario is shown in
The third example method for correcting rotation includes adding a soft material on the lingual surface on the ipsilateral side, the soft material being designed to act as a suction cup. The concept is shown in
Advantages of an example divot anchor include:
Torque Control of Anterior Teeth
As shown in
Currently, with conventional braces, torque is created in teeth by applying force in a labial-lingual direction. Although the intention is to move the root either in buccal or lingual directions, the crown always needs to move in the opposite direction, although not as much in magnitude. To achieve this movement, there should be complete engagement of the wire (the source of force) into the bracket and the system should be rigid.
The conventional design of the INVISALIGN aligner applies torque by creating contact of the aligner towards the gingival one-third of the tooth with power ridges.
Disadvantages of the conventional aligner are that the power ridges do not have a definite point of engagement, and therefore the conventional aligner does not fit on the tooth completely, which in turn reduces the efficacy of the conventional aligner system.
In an implementation, a proposed improvement creates a better engagement of the example aligner at the point of force application by making the aligner engage into the divot anchor on the buccal side towards the gingival margin, while creating spaces on the opposite side to reduce resistance. This scenario is shown in
In an implementation, an orthodontic system includes an aligner for fitting over one or more teeth to apply a force to at least one tooth, and at least one 3D-printed part of the aligner for applying the force to the at least one tooth. The at least one 3D-printed part may comprise a 3D-printed material capable of an elastic strain recovery for applying the force to the at least one tooth. The at least one 3D-printed part applies a torque, a rotational force, a leverage, a push, a pull, or at least part of a full 3D control force to the at least one tooth.
A divot anchor can independently attach to a tooth, wherein a geometry or an extension of the 3D-printed part of the aligner is configured to form a removable attachment with a divot of the divot anchor to apply a torque, a rotational force, a leverage, a push, a pull, or at least part of a full 3D control force to the tooth through the divot anchor.
Multiple divot anchors may each independently attach to a tooth, and the aligner applies a different force vector to the tooth through each of the multiple divot anchors.
The divot anchor may further comprise a groove, a channel, a notch, a depression, a cavity, or a hole for securing a tab, a flange, a rib, a hook, an extension, a geometry, or a member of the aligner for applying a force to the tooth, wherein the force comprises one of a torque, a rotational force, a leverage, a push, a pull, or at least part of a full 3D control force.
At least one 3D-printed part of the aligner may be constructed in an additive manufacturing process.
The system may further comprise a torque control feature of the aligner, the torque control feature comprising a space disposed between the aligner and at least one tooth. A compressible material may be disposed in the space between the aligner and the at least one tooth. The aligner may comprise a plurality of materials each having a different modulus of elasticity. The aligner may comprise a first material with a first modulus of elasticity for front teeth and a second material with a second modulus of elasticity for back teeth.
At least part of the aligner may be constructed in an additive manufacturing processes selected from the group consisting of a FDM process, a SLS process, a direct pellets fused deposition process, a SLA process or a DLP process, a multi-jet photo cured polymer process, a multi jet fusion technology, and a CLIP process.
An additive may be used that fades over a time interval upon contact with mouth fluids.
A microchip and a sensor may be included in the aligner to detect a tooth movement over a time interval or to measure a compliance level of a patient.
The aligner may comprise multiple thicknesses of a 3D-printed material. A pigment or a coloring agent may be included in the aligner, formulated to match a color of teeth. A polymeric coating may be placed on the aligner to reduce a surface porosity and to increase a surface smoothness of the aligner.
At least one 3D-printed part of the aligner may be composed of a material having a hardness on a Shore D scale in a range of 30-90, an elasticity modulus in a range of 1000-1800 Mpa, a tensile strength at yield in a range of 40-70 Mpa (ASTM 638-2010), Tensile Modulus in the range of 1400 Mpa to 2000 Mpa (ASTM D638), a percentage elongation at break in a range of 10-200%, Flexural strength—50-80 MPa ASTM D790, Flexural Modulus—1200-1900 MPa (ASTM D790), a percentage tear strength in a range of 45-60 MPa, Energy to break—10-20 Joules, no deformation in a range of 0.5% strain over a 8-24 hour period, a stress relaxation rate (N/s) in a range of 0.010-0.020, and a notch impact resistance at 23° C. of 10-30 kJ/m2 (ASTM D256 Test method
In a modeling block 3702, virtual models are created for the orthodontia to be performed, resulting in the 3D-printing of various sets of 3D aligners that will apply forces to the teeth, in stages that are also determined by the models. The 3D-printed aligners to be fabricated and used on a patient may also progress across a variety of materials to vary the magnitude of forces applied to the teeth.
In the modeling block 3702, a first virtual model of the teeth of a patient is produced. The first virtual model captures the patient's initial dental positions, either before orthodontia begins, for example, or from another selected starting point during orthodontia. In other words, the first virtual model represents the patient's malocclusion.
Next, virtual divot anchors are placed on the virtual teeth in the first virtual model, based on desired tooth movements.
Next, a second virtual model of orthodontic teeth movement is generated, based on the first virtual model. The second virtual model generates virtual movements of the patient's teeth, and may generate multiple stages in which the modeled tooth movements are to occur. The number of stages for applying the orthodontia may be based on the Modulus of Elasticity (MOE) of various materials for multiple aligners to be staged on the patient's teeth, a set of aligners providing tooth movement in a range of 0.3 mm-0.5 mm, for example.
Next, a third virtual model simulates and represents the various forces and vectors involved with the modeled tooth movements inputted from the second virtual model.
The modeling of block 3702 uses data collection from the patient for treatment, and may include the following steps:
1. Attain digital scan of the teeth or make physical models and scan the physical models of teeth or scan PVS impression of teeth.
2. Analyze virtual models for space discrepancy and protrusion of teeth.
3. Plan a case for treatment based on space requirements (e.g., whether or not to remove some teeth for space).
4. Based on anticipated directionality of tooth movement, virtually place divot anchors on teeth as needed.
5. From initial malocclusion position, with virtual divot anchors placed make transfer tray for the doctor based on the type of teeth movements desired, place divot anchors on teeth and acquire a scan.
6. Establish final position of teeth.
7. Establish steps and sequencing of correction (as too what movement of the teeth needs to be corrected first. such as rotation first, crowding next, and so forth) to attain changes from initial to final position of the teeth.
8. Establish staging to attain final position of teeth based on force needed to move teeth, this is based on the MOE (Modulus of Elasticity) of materials of the aligners and the amount of tooth movement to be performed. If force needed is 26 grams per cm2 at root level and a movement ranging from 0.1-0.3 mm of tooth movement per aligner is needed, the MOE of materials and stress decay force hardening of aligner is established by finite element analysis (FEA).
Example Hardware Production and Patient Treatment
At block 3704, direct-fabrication of 3D-printed aligners is accomplished.
This includes, at block 3706, selecting among various specific 3D-printing technologies, based on aligner design and final desired positions for the teeth (orthodontic correction). At least part of an aligner is to fit over one or more teeth to apply at least part of the forces to at least one tooth (based on virtual model output).
At block 3708, one or more divot anchors are affixed to one or more teeth of the patient, according to a template made from the first virtual model before tooth movement, and then the direct-fabricated 3D-printed aligner is placed over the divot anchor(s) and over the teeth of the patient.
At block 3710, the 3D-printed aligner attaches to a divot of each divot anchor and applies a torque, a rotational force, a leverage, a push, a pull, or at least part of a full 3D control force to the tooth.
At block 3712, the desired final positions of the patient's teeth are achieved according to the staging of the virtual models, using several aligners based on the force needed to move the teeth.
Support Structures for 3D Printing Processes
When considering what technology to print thin complex design 3D aligner with, it is important to consider support structures and how they may affect the final result. Support structures have an impact on surface finish as they require post-processing work to remove, resulting in blemishes or surface roughness. It is most important to eliminate or minimize support structures for very thin aligners having very intricate complex designs.
Support Structures in FDM (Fused Deposition Molding):
With FDM 3D-printing of an aligner, each layer is printed as a set of heated filament threads which adhere to the threads below and around it. Each thread is printed slightly offset from its previous layer. This allows a model to be built up to angles of 45°, allowing prints to expand beyond its previous layer's width.
As shown in
One of the limitations of using support in FDM 3D-printing is that post-processing is always required, resulting in marks or damage to the surface in contact with the support. Another issue is that layers printed upon support will be less perfect as the support will be slightly less stationary than the solid layers. Support can also be difficult to remove from small, intricate features without breaking the model. In an implementation, an example aligner uses support material that can be printed with a dissolvable material that does not tear away from the part but instead dissolves away in a chemical solution that does not affect the main material of the printed model. This can be a water- or solvent-soluble based support structure for 3D printing of the aligner. After the aligner with support structure is made, the support structure is easily removed by water jetting, or by keeping the aligner in water or solvent. This results in a better surface finish, when the support is in contact with the main material.
Support Structures for SLA & DLP
To make sure that the prints adhere to the print platform and do not float around in the vat, SLA and DLP printers require the use of supports in almost all cases. Support structures from these printers look like thin ribs, with only small tips actually touching the model to save material and printing time, as shown in
Removing support material from SLA & DLP aligners is required some work. First, isopropyl alcohol (IPA) is used to wash liquid resin off the completed aligners. Support structures can be either broken off the surface of the aligners or removed using pliers. The spots where the support was in contact with the object are then sanded to remove any remaining marks. Part orientation plays a crucial role on where support is located for SLA and DLP printing. By reorienting an aligner during printing, the amount of support (and therefore the cost of the aligner) can be drastically reduced. Orientation also plays an important role in where support will be located. If the aesthetic appearance of a surface on a component is paramount, orientating the part so that there is little to no support in contact with that area is also an option.
In
The rectangular divot attachment B provides three-dimensional control of the teeth in terms of getting the tooth to a predetermined corrected position. Force is applied from the 3D-printed aligner C that is used over the attachments B. The example 3D-printed aligners fit over the teeth and have a horizontal rectangular projection D that fits into the groove or the rectangular channel of the rectangular divot attachment B, which delivers the necessary forces to move teeth to predetermined positions. It is important to ensure a complete fit of the rectangular projection D into the grove or channel of the attachment B to attain the desired teeth movements.
To attain final teeth positions, the aligners C are changed every so often (between one to two weeks). This is done in a progressive manner with the first aligner C being soft with force exerted as a 0.014 nitinol and each getting stiffer until the aligner strength reaches 0.018×0.025 stainless steel wire.
The example flat biting surface D of the 3D-printed aligners C enables several new ways of correcting the bite, correcting teeth positions, and reducing temporomandibular joint disorder (TMD) at the same time.
Bite Correction while Correcting Teeth Position
Occlusal Orthotic or Bite Splint to Treat Temporomandibular Disorder (TMD)
Functional Appliance (Jaw Growth Promoting Appliance)
Aligners with Sleep Apnea Treatment—Dual Function Device
Obstructive sleep apnea (OSA) is a sleep disorder with partial or complete cessation of breathing during one's sleep. This sleep disorder is currently treated by methods such as a surgery, oral appliance therapy, negative pressure to pull soft palate and tongue forward, implantable devices that keep the airway open during sleep by stimulating the hypoglossal nerve, strips for the nose for expiratory positive airway pressure, Positive Air Pressure (PAP) therapy, or a combination involving several methods. PAP therapies are also employed to treat other medical and respiratory disorders, such as Cheynes-Stokes respiration, congestive heart failure, and stroke. A common PAP device comprises a flow generator (e.g., a blower) that delivers gas via delivery conduit (hollow tube) to an individual interface. It is also known to deliver the PAP as a continuous positive airway pressure (CPAP), a variable airway pressure, such as bi-level pressure (Bi-PAP) that varies with the individual's respiratory cycle or an auto-titrating pressure (APAP) that varies with the monitored condition of the individual. Nasal, oral-nasal, and full-face masks are common interfaces utilized for delivering PAP to the individual's airway.
These masks can be uncomfortable due to improper fit, tight straps to hold mask in place, skin irritation at points of contact, dryness of throat, the feelings of claustrophobia, and excessive PAP pressure are major factors in individual therapy non-compliance. Also, the PAP machines can be noisy. Studies show individual compliance for PAP therapy is less than 50%. For patients who cannot tolerate CPAP machine therapy, oral appliance therapy is an effective treatment option for snoring and obstructive sleep apnea (OSA). A custom-fit oral sleep appliance known as a mandibular advancement device (MAD), can be effective for people who cannot tolerate CPAP devices. Worn only during sleep, an MAD oral appliance fits like a sports mouth guard or an orthodontic retainer. It supports the jaw in a forward position to help maintain an open upper airway. The devices snap over the upper and lower dental arches and have several designs/concepts for the lower jaw to be eased forward. Some, devices allow patient to control the degree of advancement. But there is no device on the market for children as well as adults to treat sleep apnea while they going through the process of straightening teeth with aligners, except the combination of conventional aligners with conventional PAP devices, which is not a comfortable combination. Most importantly, treating both conditions is an advantage in preparation for definitive treatment with orthognathic surgery (jaw surgery).
Aligners/Sleep Apnea Device with Mandibular Advancement
The hooks on the example aligner can be 3D-printed on the aligner (i.e., attached) in forward or backward positions of upper and lower 3D-printed aligners, as an attachment. The nighttime aligner allows the lower jaw to move forward, not only treating the sleep apnea (keeping the airway open), but also simultaneously and continuously correcting teeth position in the same manner as the daytime aligner. There are not separate day and nighttime aligners, elastic is just attached on hooks for the nighttime to bring the lower jaw forward. As shown in
One can use the example sleep apnea orthodontic aligner with or without the flat plastic member attached to the aligner, if this is not part of the aligner, the flat plastic member can be made as an auxiliary appliance or additional appliance to fit between the upper and lower aligner anchored to the vertical slot of a single or multiple divot attachment. The plastics between the upper and lower 3D-printed aligners are indented (the plastic goes between teeth) to hold the jaw in a forward position, and the jaw held forward is supported with the help of elastics, and attached to 3D-printed attachments on the aligner such that the jaw does not go back and the jaw does not open during sleep. This system can be used as a sleep apnea appliance, while simultaneously correcting teeth positions. During daytime, if the plastic member is part of the aligner, then a different daytime aligner is needed. If the plastic member is an auxiliary appliance, then just removing the plastic member and discontinuing the elastic suffices during the daytime. This system allows continued teeth movement during the day and night uninterrupted.
Aligners/Sleep Apnea Device without Mandibular Advancement
Another example aligner treats sleep apnea and straightens teeth without moving the lower jaw forward. Here, as described below, “daytime aligners” and “nighttime aligners (modified daytime aligners)” are used by the patient. This is specifically very useful for children that have sleep apnea, as CPAP machine compliance level is very low due to low comfort level, need of constant face mask changes due to the growth of children in order to prevent air leakage, and conventional oral appliances to bring the jaw forward cannot be used for children wearing conventional aligners or conventional braces treatments. The example aligners can include several design modifications for not bringing the lower jaw forward.
A target air pressure and airflow is achieved to keep the patient's air passage open, to treat the sleep apnea (airflow is automatically adjusted continuously during sleep) by controlling the speed of micro blower(s). This automatic control of the micro blower's speed is achieved by utilizing feedback from the sensors and microprocessor having a closed loop feedback control system with control logic, using a compact control module with PCB “H” inserted inside the front hollow housing E in
The functionality of the example aligner to straighten teeth during the night is not affected using the sleep apnea treatment modification of the aligner system, which does not require bringing the lower jaw forward.
At least one 3D-printed part of an aligner may be made by fused deposit molding (FDM), an additive manufacturing process, containing monofilament where a soft, lower molecular weight material is disposed on the surface during 3D printing, or a dual filament has a core-shell structure in which the shell can be a soft material or a material with different crystallinity or different MOE than the non-shell.
Aligners/Sleep Apnea Device with Mandibular Advancement and Air Passage Through Front Hollow Housing and Tubes on Aligner
An example aligner system includes an orthodontic aligner capable of providing sleep apnea treatment, which moves the lower jaw forward (
Dual Purpose Orthodontic Appliance Having Aligners to Straighten the Teeth or Teeth Trays to Prevent the Bruxism and to Treat Sleep Apnea Simultaneously with Smart Sensors and Control Module System
In this embodiment, the purpose of dual-purpose appliance is described as simultaneously treating the Sleep Apnea and use of teeth trays for straightening the teeth (desired movement of teeth) or reducing the bruxism (teeth grinding) or reducing the TMJ. Going forwards, the teeth trays are defined as “aligners” or “bite splint” or “night guard” or “mouthguard”. The appliance has smart sensors, control module, microprocessor, battery, wireless transmission, data storage, etc., which is described in different embodiments. Going forward “Control module System” is defined as module consists of microprocessor, PCB, memory storage, battery, wireless transmission, data storage and micro-blower when needed.
The dual-purpose orthodontic system has one or more 3D-printed parts of the 3D-printed aligner or teeth trays made from one or combinations of the several additive manufacturing methods.
I: Dual Purpose Appliances (Devices) without Detachable External Housing (No Micro-Blower, No Battery, No Microprocessor).
I-1. “Dual Purpose” MAD Appliance Having Smart Sensors and Hollow Passageway on Teeth Trays
I-1A. Teeth Trays Having Hollow Oval Shape Tube (Air Passageways) Starting from the Outside of the Mouth and Surrounding the Teeth Trays
In this embodiment, hollow air passageway of the teeth trays relates to hollow opening starting from the lip area. As shown in
In some embodiments, one of the several sensors and control module are mounted on the air passageway (hollow tubes) connected to the teeth trays. For example, 5306 sensor is mounted on the air passageway.
In some embodiments, one of the several sensors and control module are mounted on upper or lower the teeth trays or on both teeth trays. For example, 5307 control module is mounted on the lower teeth tray.
In some embodiments, one of the several sensors and control module are mounted on the air passageway and teeth trays. Here, control module system is shown at lower teeth tray 5308 but can be anywhere depending on the customized teeth trays design.
Types of smart sensors and their functions are described later on in sensors and communication section.
For Dual purpose MAD devise, the smart sensors and control module are used for several purposes. It is useful to allow the MAD and other sleep apnea treatment concepts respond in real time to the changes in the patient to provide the most effective mandibular position adjustment for the patient at the particular time. In addition, physicians would like to know the history of the changes in the patient's body while the MAD and other sleep apnea treatment concepts are being used in order to provide a better treatment regimen.
The first function of the Dual-Purpose appliance of the teeth trays is to align the teeth or reduce the bruxism (use of bite splint, nightguard etc.) as defined in previous CIP patent.
The second function of the teeth trays is to treat the sleep apnea with MAD device concept to reduce the sleep apnea along with several concepts, as described below
I-1A-a Air Stimulation of Tongue and Toning of the Tongue with MAD
In some embodiments, sleep apnea is reduced using two concepts. The first concept is use of MAD device concept (Mandibular advancement) where lower jaw is brought forward reducing the sleep apnea along with the air stimulation of tongue, meaning air is brought at the rear of the throat by-passing the tongue as shown at 5302 and 5303.
The device brings air in at atmospheric pressure during the inhalation at 5301 and the air moves from the front of the mouth to rear of the throat, completely bypassing the tongue. It stabilizes the lower jaw and tongue, keeping airways open and free from obstruction during sleep. The device has capability of air stimulation of tongue and soft tissues which may not allow soft tissues to relax, keeping air passageway in throat area open during the sleep.
In some embodiments, sleep apnea is reduced using combination concepts. The first concept is use of MAD device concept (Mandibular advancement) where lower jaw is brought forward using linkage 5310 reducing the sleep apnea along with the air stimulation of tongue using micro-holes in the hollow tubes 5302 and 5303 of air passageway of lower teeth tray. There can be continuous air flow (air-puff) through these micro holes which blows the air underneath or near the tongue the area where hypoglossal nerves and other soft tissues are located. Here, end of the tubes 5302 and 5303 are closed to create air velocity and pressure to stimulation tongue. The air comes out from these very small holes underneath the tongue area as “air puffs' slight air pressure, stimulating the to the lower part of the tongue's muscles and nerves, causing the tongue to return to its normal forward position, opening up the air passage in the oropharynx area, aiding reduction of episodes of sleep apnea.
I-1A-b Electric Stimulation of Tongue and Toning of the Tongue with MAD Device
Neuro/muscle stimulation of the Tongue or toning of the tongue is done by electric current using electrode or any other means of giving minor electric shock to tongue to keep tongue forward and/or bring it forward if retracted. One or a combination of sensors such as tongue touch sensor, position sensor or pressure sensors are used to find the normal position of tongue (tongue forward). For examples, these sensors are shown as 5309 and 5308. The length or numbers of position sensors are such that it should instantly recognize the tongue in forward position and when tongue retracts. This depends on mouth size as each patient's teeth trays have different size. These sensors are located on the upper or lower teeth tray to allow sensing of deviation of the tongue from its normal forward position. This data is fed into a control module with AI capabilities. During the sleep, when tongue retracts, the control module recognizes it and using AI algorithm, provides minor shock to the lower part of the tongue's muscles and nerves, causing the tongue to return to its normal forward position, opening up the air passage in the oropharynx area, aiding reduction of episodes of sleep apnea.
In one example, electrodes pass through the opening of the hollow air passageway surrounding the teeth tray. In other example, the electrodes are bonded to the teeth tray but not affected by the inner fluid of the mouth as electrode are coated with FDA approved adhesive.
In one of the embodiments of MAD or non-MAD device with air passageway connected to teeth tray, preferably to lower teeth tray, leads are attached surgically underneath the tongue and electrodes are attached on the teeth tray, preferable lower teeth tray 5305. Here, the electric shock is given to hypoglossal nerve to keep the tongue forward in addition to air stimulation methods as described earlier.
For neurostimulation of tongue using minimal electric current, the dual-purpose appliance can be used without need of micro blower, eliminating a need of external detachable housing box.
For an example, the control module utilizes standard lithium-ion battery or solid-state battery when available and can adjust voltages from 1 to 3.7V and or up to 5V and provide pulsed current of 1 to 4 mA for 1-2 minutes. The amount of volt and amperage depends on number of apnea episodes patients have. In current embodiment, aim is to provide a pulsed current to the inside of the mouth in the proximity of the hypoglossal nerve and/or nerves/muscles of the tongue. The electric shock is applied only when tongue retracts to minimize the voltage and current requirements of the battery.
Electrodes can be sourced from current biomedically approved units currently available in the market. The electrode is attached to end of wire that can be passed through the hollow tube or bonded to the teeth trays which are not in contact of the teeth in close proximity to oropharynx area and in vicinity of the hypoglossal nerves.
One embodiment envisages a machine learning AI (Artificial Intelligent) system, that can learn episodes of tongue retraction due to signaling from brain to hypoglossal nerve and apply counteracting electric currents once a pattern is established.
In one of the embodiments, by using the safe electric current, which is applied continuously to stimulate and improve muscle function in the mouth and tongue (tone the tongue muscle). In effect, this gives tongue muscles a “work out” exercising them like any other muscle group, making them strong. If patient sleeps with device for few weeks, the tongue muscles will be strengthened and toned, will become strong and sleep apnea level will reduce significantly. Then, the patients may not have to use the appliance for few months till HST (home sleep testing) shows that AHI index (sleep apnea level) has increased again. The patient will again sleep with appliance for few weeks followed by no wearing of appliance for few months. Eventually, sleep apnea level can be significantly reduced to a level that patient may not need to use appliance for few months as tongue muscles will be strong enough, will not relax, not allowing the tongue to fall.
I-1A-c Air-Electric (Hybrid) Stimulation of Tongue and Toning of the Tongue with MAD Device
Here, device uses the both concepts of tongue stimulation which are described above in 1A-a and 1A-b which are air stimulation in combination with electric stimulation of tongue of MAD device.
I-1B.
Teeth trays having hollow air passageways ONLY surrounding the teeth trays inside the mouth, No Oval shape hollow tube outside the mouth
Here, the concept is same as 1A except there is no oval shape hollow tube sticking out from the mouth as a part of the device. As shown in
Here sleep apnea is reduced by MAD device approach along with the electric Stimulation of Tongue as explain above in I-1A-b. The benefit of this concept that device stays closed during the sleep. One can use adhesive tape, chin trap or any other commercially available to keep mouth closed during the sleep, allowing nose breathing. At the same time, the device functions as Dual purpose, aligning the teeth or reducing the bruxism and reducing the sleep apnea.
If mouth opens during the sleep, air is directed to the back of the throat due to oval shape opening in the front, by-passing the front of tongue, while stimulating (toning) the tongue and soft tissues at the back, keeping the air passage open in throat are, reducing sleep apnea. This air stimulation is described more detail in I-1A-a. One can use hybrid stimulation as described in I-1A-a and I-1A-b reduce sleep apnea in addition where teeth trays which can function as to align the teeth or reduce the bruxism using bite splint or reduce teeth grinding using nightguard, this way device functions two purposes.
Advantages of the teeth trays with or without air passageway having sensor combinations for Dual Purpose appliance is disclosed herein are many. The appliance with teeth trays in its totality is 100% self-contained and resides completely secure inside the patient's mouth, enabling complete lip seal. The device is custom manufactured—by combining the patient's anatomical data input and a health care provider's (HCP) prescription with a manufacturing library of elements—to seamlessly integrate the sensors and device mechanisms with the patient's comfort in mind.
In some embodiments, if the teeth trays with or without air passageway comprises more than one sensor, then the Dual-Purpose appliance is designed and manufactured such that the sensors are on one teeth trays, either the upper or the lower teeth tray, or on the outside wall of the hollow tube (air passageway) of the appliance. In other embodiments, the sensors are on different teeth trays or on hollow air passageways. Throughout the present disclosure, the teeth tray with air passageway bearing the sensor(s) called the “technical teeth tray” while the teeth tray without any sensors is called the “free teeth tray.”
In some embodiments, the teeth trays with hollow air passageways are designed such that the most critical components, e.g., the sensors and control modules, are protected.
I-2. “Dual Purpose” MAD Appliance Having Smart Sensors without Hollow Air Passageway on Teeth Trays
As shown in
Neuro/muscle stimulation of the Tongue or toning of the tongue is done by electric current using electrode or any other means of giving minor electric shock to tongue to keep tongue forward and/or bring it forward if retracted. Here, electrodes are shown as 5508 at the end of lower teeth tray. One or a combination of sensors such as tongue touch sensor, position sensor or pressure sensors are used to find the normal position of tongue (tongue forward). These sensors are located on the upper or lower teeth tray to allow sensing of deviation of the tongue from its normal forward position. 5502 and 5504 are shown as tongue position sensor. The length or numbers of position sensors are such that it should instantly recognize the tongue in forward position and when tongue retracts. This depends on mouth size as each patient's teeth trays have different size. These sensors are located on the upper or lower teeth tray to allow sensing of deviation of the tongue from its normal forward position. This data from the position sensors is fed into a control module with AI capabilities. During the sleep, when tongue retracts, the control module recognizes it and using AI algorithm, provides minor shock, using minor electric current by electrode to the lower part of the tongue's muscles and nerves, causing the tongue to return to its normal forward position, opening up the air passage in the oropharynx area, aiding reduction of episodes of sleep apnea.
The electrodes are bonded to the teeth tray(s) but not affected by the inner fluid of the mouth as electrode are coated with FDA approved adhesive.
In one of the embodiments of MAD or non-MAD device, the leads are attached surgically underneath the tongue, near hypoglossal nerves and electrodes are attached on the teeth tray, preferable lower teeth tray. Here, the electric shock is given to hypoglossal nerve to keep the tongue forward.
For an example, the control module utilizes standard lithium-ion battery or solid-state battery when available and can adjust voltages from 1 to 3.7V and or up to 5V and provide pulsed current of 1 to 4 mA for 1-2 minutes. The amount of volt and amperage depends on number of apnea episodes patients have. In current embodiment, aim is to provide a pulsed current to the inside of the mouth in the proximity of the hypoglossal nerve and/or nerves/muscles of the tongue. The electric shock is applied only when tongue retracts to minimize the voltage and current requirements of the battery.
Electrodes can be sourced from current biomedically approved units currently available in the market. The electrode is attached to end of wire that can be passed through the hollow tube or bonded to the teeth trays which are not in contact of the teeth in close proximity to oropharynx area and in vicinity of the hypoglossal nerves.
One embodiment envisages a machine learning AI system, that can learn episodes of tongue retraction due to signaling from brain to hypoglossal nerve and apply counteracting electric currents once a pattern is established.
In one of the embodiments, by using the safe electric current, which is applied continuously to stimulate and improve muscle function in the mouth and tongue (tone the tongue muscle). In effect, this gives tongue muscles a “work out” exercising them like any other muscle group, making them strong. If patient sleeps with device for few weeks, the tongue muscles will be strengthened and toned, will become strong and sleep apnea level will reduce significantly. Then, the patients may not have to use the appliance for few months till HST (home sleep testing) shows that AHI index (sleep apnea level) has increased. The patient will again sleep with appliance for few weeks followed by no wearing of appliance for few months. Eventually, sleep apnea level can be significantly reduced to a level that patient may not need to use appliance for few months as tongue muscles will be strong enough, not allowing the tongue to fall (tongue and soft tissues are strong enough, they will not relax for few months).
I-3. “Dual Purpose” NO MAD Appliance with Teeth Trays Having Air passageway from outside and on teeth trays
In one of the embodiments, the dual-purpose appliance has upper tray or lower tray having hollow passageway, preferably lower tray 5602 as shown in
Here, the lower teeth tray function as electric stimulation of tongue nerves and toning of the tongue muscle by different mechanism are as explain in I-1A-b. The 5603 is tongue position sensor(s) and 5604 is control module and 5605 is one of the several sensors.
I-4. “Dual Purpose” No MAD Appliance with Teeth Trays with Air Passageway ONLY on Teeth Trays:
In one of the embodiments, As shown in
Here, the lower teeth tray function as electric stimulation of tongue nerves and toning of the tongue muscle by different mechanism are as explain in I-1A-b.
The air enters through 5701 opening if mouth gets open during the sleep and air goes int o throat area, by passing the tongue, reducing sleep apnea episodes (air stimulation). Air stimulation of the tongue can be also done by providing micro-holes as described earlier. 5706 is tongue position sensor and 5703 shows the electrode located at the end of the teeth tray, in throat area. 5704 is control module while 5705 is one or several sensors located in this area.
Here the patient sleeps with mouth closed but air stimulation also occurs if mouth opens, reducing the sleep apnea further in addition to electric current stimulation (minor shock) mechanism.
I-5. “Dual Purpose” Appliance with Teeth Trays without Air Passageway and Having Smart Sensors and No MAD
In one of the embodiments, the dual-purpose appliance has ONLY upper tray or lower, preferably lower tray 5801 as shown in
The electric stimulation of tongue nerves and toning of the tongue muscle are shown by different mechanism in I-1A-b. 5804 is tongue position sensor while 5802 are electrode to provide minor electric shock to the tongue as described in I-1A-b. 5803 is control module while 5805 consists of one or several sensors.
In all above examples, Sleep Position Training is done by using smart sensors such as Gyroscope with or w/o accelerometer and giving minor electric shock to lips or vibration to lips or surrounding area if person sleeps on back, teaching person to sleep on side (feedback mechanism). Here, the dual-purpose appliance can be used without need of micro blower, eliminating a need of external detachable housing box if control module is attached to lip area of the appliance. The smart sensors are attached to outside ovel shape hollow passageway or on the teeth trays or on the hollow air passageways connected to teeth trays and or both.
HST and “Dual Purpose” Device: The dual-purpose appliance with smart sensors can also work as HST device, measuring the parameters such as AHI, Oxygen saturation, snoring (three in one device) and even it can measure brain activity. External detachable housing having sensors along with sensors on teeth trays are useful in some cases. The data from smart sensors and algorithm and use of blue tooth or Wi-Fi technology is used to transfer the data in real time.
II: Dual Purpose Appliances (Devices) WITH External Detachable Housing
II-1. “Dual Purpose” MAD Appliance Having Smart Sensors and Hollow Passageway on Teeth Trays
The detachable oral sleep treatment device includes a front hollow housing defining a first through passage defining an inlet aperture and an output aperture, said front hollow housing having an exterior surface configured to engage the patient's lips the front hollow housing having a first detachable locking interface adjacent the output aperture. The detachable oral sleep treatment device further includes an air flow generating device or air pressure generating device disposed within the first through passage, the generating device configured to create an airflow from the inlet aperture through the output aperture the air flow generating device comprises a controller configured to regulate electrical power supplied to the generating device and a battery disposed within the front hollow housing, said battery being electrically coupled to the airflow generating device and the controller, and a mouthpiece defining first mouthpiece aperture selectively coupled to the front housing, the mouthpiece having first and second curved members together defining a u-shape and having an exterior surface defining a tooth engaging surface, said first and second members defining second and third through passages, said first and second rear mouthpiece apertures disposed adjacent to the retromolar pad members when said mouthpiece is engaged with the patient's teeth.
In one of the embodiments, as shown in
The sensors and control modules can be separated from each other wirelessly or with wires.
The first function of the Dual-Purpose appliance of the teeth trays is to align the teeth or reduce the bruxism (use of bite splint, nightguard etc.) as defined in previous CIP patent.
The second function of the teeth trays is to treat the sleep apnea with MAD device concept to reduce the sleep apnea along with other concepts, as shown below
One of the embodiments, Air Stimulation of Tongue and toning of the tongue with MAD is achieved as explained in I-1A-a.
One of the embodiments, The Electric Stimulation of Tongue and toning of the tongue with MAD device is explained in I-1A-b.
One of the embodiments, The Air-Electric (Hybrid) Stimulation of Tongue and toning of the tongue with MAD device is explained in I-1A-c.
Only difference here is compared to I-1 is that the appliance has external detachable housing as shown in the figure.
As shown in
According to the invention above, where the controller is configured to store data related to the plurality of sensors comprising one of a pressure sensor, an airflow sensor and one or more temperature sensors, sound sensor, accelerometer, tilt sensor, and a pulse oximeter.
II-2. “Dual Purpose” Appliance with External Housing Having “No Micro-Blower” and Teeth Trays without Air Passageway
One of the embodiments, the dual-purpose appliance has external housing 6102 without the micro-blower as shown in
II-3. “Dual Purpose” NO—MAD Appliance Having Smart Sensors and Hollow Passageway on Teeth Trays
In one of the embodiments, the smart sensors with control modules systems are located in the external detachable housing or on teeth trays or on hollow tubes (air passageways) connected to teeth trays. Here,
According to the invention above, where the controller is configured to store data related to the plurality of sensors comprising one of a pressure sensor, an airflow sensor and one or more temperature sensors, sound sensor, accelerometer, tilt sensor, and a pulse oximeter. Other sensors are described in “Sensors” sections and their functions.
In one of the embodiments, there is NO—MAD, meaning only upper teeth tray or preferably lower teeth tray is connected to the external detachable housing.
The sensors and control modules can be separated from each other wirelessly or with wires.
In one of the embodiments, the dual-purpose appliance has upper tray or lower tray having hollow passageway, preferably lower tray. One of the teeth tray's functions is to straighten the teeth as an aligner or reduce bruxism or reduce teeth grinding while other function of teeth trays is to reduce the sleep apnea by different mechanism, appliance functioning as “Dual Purpose”. The 6206 is tongue position sensor. 6205 is control module on the tray. 6204 is a sensor or combination of sensors depending on the final function of the device.
One of the embodiments, Air Stimulation of Tongue and toning of the tongue with MAD is achieved as explained in I-1A-a.
One of the embodiments, The Electric Stimulation of Tongue and toning of the tongue with MAD device is explained in I-1A-b.
One of the embodiments, The Air-Electric (Hybrid) Stimulation of Tongue and toning of the tongue with MAD device is explained in I-1A-c.
Sensors and their Functions
A variety of sensors are contemplated to be used with the disclosed. The sensors can be mounted in the external detachable housing and or on the teeth trays and or on the hollow air passageways, depending on the dual-purpose appliance as described in I and II are used.
In general, the sensors can be divided into the following categories: physiological sensors, physical sensors, chemical sensors, and positional sensors.
In some embodiments, physiological sensors measure and relay such physiological data as body temperature, respiration rate, heart rate, or other relevant physiological data, and/or any variability in the above values.
In some embodiments, physical sensors are those that detect the mode of breathing, e.g., vibration in the breathing, airflow rate, oxygen concentration of inhaled air, etc., and correlate that to airflow restriction.
In some embodiments, the sensor is selected from an oxygen sensor measuring the oxygen concentration of the inhaled air, a carbon dioxide sensor measuring the carbon dioxide concentration of the exhaled air, a pressure sensor measuring the atmospheric pressure or the air pressure inside the oral cavity, an airflow sensor, a noise detector, or an actigraphy sensor.
The sensors can also detect snoring, and/or perform airway flow signature analysis.
This combination of sensors and using algorithm/software provides the information on episodes of sleep apnea and tell the microprocess to take corrective actions to keep tongue to its normal forward position, opening up the air passage in the oropharynx area, aiding reduction of episodes of sleep apnea.
In some embodiments, the sensor measures the pressure exerted on the teeth trays by the patient's teeth in order to measure the extent of clenching and/or grinding of dentition surfaces.
In some embodiments, the smart sensors such as Gyroscope with or w/o accelerometer are used for Sleep Position Training. It is done by using and giving minor electric shock to lips or tongue or vibration to lips or tongue and or surrounding area if person sleeps on back, teaching person to sleep on side (feedback mechanism).
In some embodiments, when sensors are mounted on the teeth trays, chemical sensors are used to measure the body's physiological response to breathing. For example, the saliva pH, saliva sugar concentration, saliva conductivity, levels of stress markers, such as salivary cortisol, blood oxygen saturation level, blood pH, blood glucose levels, blood insulin levels, inflammatory markers, and the like, can be measured in real time and reported to the HCP via the base. Bacterial biosensors can provide information to the HCP on the level of bacterial activity in the mouth during sleep.
In some embodiments, the sensor is a component of a control module system, which includes other components besides the sensor.
In certain embodiments, the a control module system components include sensor sensing mechanism, one or more of a battery (rechargeable or replaceable), a battery recharging circuit compatible with industry standards, if applicable, on-board memory, communication module, analog/digital converter to convert sensor voltage inputs to digital signal etc.
In some embodiments, computer aided design (CAD) program are used where to put sensors and control module system during the design of the teeth trays with or without external detachable housing.
Communication
The presently disclosed sensors are in wireless communication with a base, transmitting the data they obtained. Various modes of wireless communication are well-known in the art. Currently, the most popular mode appears to be Bluetooth® communication. Other modes such as radio, infrared, magnetic, or the like can also be used. All modes of wireless communication now known or developed in the future are contemplated for use with the presently disclosed sensors.
In some embodiments, the base is a software contained in a physical cradle. The cradle is configured for wireless communication with the sensor embedded in the teeth tray with or without air passageways. In some embodiments, following the use, the patient places the teeth trays with or without air passageways in the cradle, which can optionally recharge the batteries of the sensor.
The battery can also be recharged directly using USB port.
In some embodiments, the cradle is configured to clean the teeth trays with or without air passageways, for example, by providing a bath into which the teeth trays can be placed, or by having a well-contained chamber for the teeth trays to be cleaned using cleansers or steam or the like. In other embodiments, the base is a software (including an app) on a smart phone (e.g., iPhone®, Galaxy®), smart tablet (e.g., iPad®, Surface®), or a laptop or desktop computer (collectively “a device”).
In some embodiments, the base will sound an alarm audible enough to wake the patient up, if the physiological data, such as the blood oxygen level or air flow disturbance, indicate an unhealthy state for the patient to continue to be sleeping.
In other embodiments, the base relays a command to the teeth trays with or without air passage to release a repugnant chemical substance in the mouth, such as one with a bitter taste, to wake the patient up.
In some embodiments, the base is programmed to alert the emergency medical services if the physiological data is worsening and the patient shows no sign of waking up, for example, by turning the alarm off.
In some embodiments, the presently disclosed combination of teeth trays with or without air passageway and sensors is used to deliver medications to the patient in a controlled fashion.
In some of these embodiments, the teeth trays with or without air passageway comprises built-in refillable cavities that can be filled with a prescribed medication.
In other embodiments, the teeth trays with or without air passageway comprises a location for a prefilled container of medication to be placed. In any case, the design of the teeth trays with or without air passageway with the medication-dispensing components is such that the patient does not feel the bulk of the medication-dispensing components and the appliance is as comfortable to wear as if it did not have the medication-dispensing components.
In response to a time cue or input from an embedded sensor, the base relays a command to the teeth trays with or without air passage way and the medication-dispensing components to release a preset amount of the medication either between the cheek and the gum for a buccal administration or into the patient's mouth for the medication to be inhaled. Examples include stress reducing agents, calming agents, glucose, insulin, nitroglycerin or other heart medications for atrial fibrillation or unstable angina, and the like.
In some embodiments, the base is also in wireless communication with a software on a device operated by a health care provider (HCP). In these embodiments, the base communicates the collected data directly to the HCP device, where the HCP can monitor the progress of the patient without the need for the patient to make office visits. This feature is quite useful for individuals who travel constantly, such as salespersons, long distance drivers, airline pilots, and the like. By taking advantage of this feature, the HCP can continually monitor the patient and intervene with a recommendation if that is in the best interest of the patient. This way, problems are detected and corrected as they happen.
In some embodiments, the base communicates with the HCP software through the internet, phone lines, satellite, radio, microwave, or other forms of long distance communication now known or later developed.
In some embodiments, multiple sensors are connected to the same control module system, whereas in other embodiments, each sensor has its own control module system.
In the foregoing description, the invention has been described with reference to specific exemplary embodiments thereof. It will be apparent to those skilled in the art that a person understanding this invention may conceive of changes or other embodiments or variations, which utilize the principles of this invention without departing from the broader spirit and scope of the invention. The specification and drawings are, therefore, to be regarded in an illustrative rather than a restrictive sense.
This continuation-in-part (CIP) patent application claims the benefit of priority to U.S. patent application Ser. No. 16/248,430 to Shivapuja et al., filed Jan. 15, 2019 and now U.S. Pat. No. 11,484,390, which in turn claims priority to U.S. patent application Ser. No. 15/062,043 to Shivapuja et al., filed Mar. 4, 2016, now U.S. Pat. No. 10,179,035, which in turn claims priority to U.S. Provisional Patent Application No. 62/128,450 to Shivapuja et al., filed Mar. 4, 2015, all of these incorporated by reference herein in their entireties.
Number | Date | Country | |
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62128450 | Mar 2015 | US |
Number | Date | Country | |
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Parent | 16248430 | Jan 2019 | US |
Child | 17977717 | US | |
Parent | 15062043 | Mar 2016 | US |
Child | 16248430 | US |