Apparatus, system and method for dental treatment
阅读说明：本技术 用于牙科治疗的设备、系统和方法 (Apparatus, system and method for dental treatment ) 是由 丹尼尔·桑德斯 于 2018-11-26 设计创作，主要内容包括：提供了用于治疗口腔的装置、方法和系统。该装置包括适于实施牙科治疗的口部件,其中,该口部件包括一个或更多个库存弹性体牙科覆盖层和一个或更多个治疗供给层,其中,一个或更多个库存弹性体牙科覆盖层适于形成并维持具有真空流体密封的治疗腔,其中,牙科覆盖层包括在上牙和周围牙龈上的层和/或在下牙和周围牙龈上的层,其中,层中的每个层均包括一个或更多个硬化部分,以用于在暴露于真空压力时能够实现选定的/不同的可塌陷性,其中,治疗供给层结合有加热单元和一个或更多个流动通道,加热单元用于加热治疗材料,一个或更多个流动通道与治疗腔流体连通,使得治疗供给层可以将一个或更多个治疗流体递送至一个或更多个流体密封的治疗腔以及/或者将一个或更多个治疗流体从一个或更多个流体密封的治疗腔去除。(Devices, methods, and systems for treating the oral cavity are provided. The device comprises a mouthpiece adapted to perform a dental treatment, wherein the mouthpiece comprises one or more stock elastomeric dental overlays and one or more treatment delivery layers, wherein the one or more stock elastomeric dental overlays are adapted to form and maintain a treatment cavity having a vacuum fluid seal, wherein the dental overlays comprise layers on the upper teeth and surrounding gums and/or layers on the lower teeth and surrounding gums, wherein each of the layers comprises one or more hardened portions for enabling selected/different collapsibility when exposed to vacuum pressure, wherein the treatment delivery layer incorporates a heating unit for heating the treatment material and one or more flow channels in fluid communication with the treatment cavity such that the treatment delivery layer can deliver one or more treatment fluids to the one or more fluid sealed treatment cavities and/or to the one or more fluid sealed treatment cavities One or more treatment fluids are removed from the one or more fluidly sealed treatment lumens.)
1. An apparatus, comprising:
an oral part adapted to perform a dental treatment, wherein the oral part comprises:
i. one or more stock elastomeric dental overlays adapted to form one or more fluid-tight treatment chambers having a vacuum below ambient pressure, wherein each dental overlay comprises a layer on the upper teeth and surrounding gums and/or a layer on the lower teeth and surrounding gums; and
one or more therapy delivery layers, wherein the therapy delivery layer has one or more flow channels in fluid communication with the therapy lumen such that the therapy delivery layer is capable of delivering and/or removing one or more therapeutic fluids to and/or from the therapy lumen,
wherein each dental stock layer comprises one or more hardened portions for enabling a selected/different collapsibility when exposed to vacuum pressure.
2. The device of claim 1, wherein the one or more stiffening portions is an outer frame coupled to a soft mouth piece.
3. The device of claim 1, wherein the one or more stiffening portions is an inner frame partially or fully embedded in a soft mouth member.
4. The device of claim 1, wherein a dental cover vacuum is created using a continuous sealing mechanism comprising a sealing edge formed of a compressible material in combination with one or more sealing plugs attachable to one or more rear openings of the dental overlay, wherein the sealing mechanism fluidly seals the treatment cavity.
5. The device of claim 2, wherein the sealing mechanism is adapted to prevent saliva from entering the treatment cavity and to prevent treatment material from exiting the treatment cavity.
6. The apparatus of claim 1, wherein the therapy delivery layer comprises one or more heaters for heating a therapeutic material, for heating at least a portion of the treatment lumen, or for heating at least a portion of the treatment lumen and the therapeutic material.
7. The device of claim 1, wherein the device comprises a handle integral with the treatment delivery layer, the handle adapted to: inserting the one or more dental coatings onto the upper and surrounding gingiva and/or the lower and surrounding gingiva, adjusting the position of the one or more dental coatings, removing the dental coatings after completion of a dental treatment, or any combination thereof, and adapted to be securely connected to a heating unit by means of a fluid seal, wherein the heating unit is connected to a fluid supply line and/or a vacuum supply line.
8. The device of claim 1, wherein the device comprises a power cord for delivering electrical current to the therapy delivery layer and one or more tubes for delivering one or more therapeutic materials to and/or removing the one or more therapeutic materials from the therapy delivery layer, the handle comprising the power cord; or comprises the power cord and the one or more tubes.
9. The device of claim 1, wherein the dental overlay covers a gum ridge.
10. The device of claim 1, wherein the device comprises two dental overlays for overlaying the upper and peripheral gingiva and the lower and peripheral gingiva and at least one treatment delivery layer interposed between the two dental overlays to enable the upper and peripheral gingiva and the lower and peripheral gingiva to be treated simultaneously, wherein the device comprises one or more respiratory vent openings in the treatment delivery layer and adapted to provide air access to the mouth during dental treatment.
11. The device of claim 1, wherein the handle comprises one or more inflow tubes for flowing one or more therapeutic materials into the therapy delivery layer and one or more outflow tubes for flowing one or more therapeutic materials out of the therapy delivery layer.
12. The device of claim 1, wherein the port member comprises one or more delivery orifices for flowing therapeutic material from the treatment delivery layer to the treatment lumen and one or more discharge orifices for flowing therapeutic material from the treatment lumen to the treatment delivery layer, and wherein the treatment delivery layer comprises one or more delivery channels for transporting therapeutic material from an inflow tube to the treatment lumen and one or more discharge channels for transporting therapeutic material from one or more discharge orifices to an outflow tube.
13. The apparatus of claim 1, wherein the dental overlay comprises one or more compressible rear cavity plugs adapted to seal the cavity to prevent material from flowing out of the backside of the vacuum formed layer.
14. The apparatus of claim 1, wherein the apparatus comprises one or any combination of the following design features: the dental overlay incorporates a circumferential rolled boundary skirt design to conform to the buccal and/or palatal/lingual sides of the gum ridge; the dental treatment delivery layer is located between the upper and lower dental overlays and the mouthpiece is shaped to reflect a hinge axis angle to facilitate natural jaw movement.
15. The apparatus of claim 1, wherein the fluid-tight vacuum is formed via the treatment delivery layer by reducing a pressure in the one or more dental treatment chambers below an ambient pressure, and the vacuum is maintained while flowing a treatment material into the dental treatment chambers.
16. The device of claim 1, wherein the device comprises a resilient dental gum protector component that can be adapted to selectively cover an upper gum ridge and/or a lower gum ridge for providing additional protection from treatment materials.
17. The device of claim 1, wherein the device comprises a dental gum protector component comprising a gum treatment layer on an inner surface of the dental gum protector component for delivering one or more therapeutic materials to the gum.
18. A dental gum protector comprising a flexible elastomeric arched barrier designed to substantially conform to the gingival ridge anatomy and having pre-configured individual incised apertures for customized insertion over and through the erupted anatomical crown portion of an individual upper and/or lower tooth for providing a fluid-tight dry zone.
19. The dental gum protector of claim 18, wherein the dental gum protector comprises a plurality of built-in channels on buccal, occlusal and/or lingual/palatal sides of the dental gum protector, the plurality of built-in channels being pre-filled with a light curable resin material for enhancing selective fitting and selective fluid sealing of the gum protector with upper and/or lower gingival ridges.
20. A method for performing a dental treatment, the method comprising:
i. positioning a mouthpiece comprising one or more dental overlays on the upper teeth and the surrounding gums and/or the lower teeth and the surrounding gums;
applying a fluid-tight vacuum to the dental overlay such that a fluid-tight treatment cavity at a pressure below ambient pressure is formed around the teeth and surrounding gums;
flowing one or more treatment materials into the fluid-tight treatment cavity, wherein the dental overlay comprises one or more hardened portions for enabling selected/different collapsibility of the mouthpiece when exposed to vacuum pressure; and
flowing one or more treatment materials from one or more of the fluid-tight treatment lumens to a waste container.
21. The method of claim 20, wherein the method comprises one or any combination of the following steps:
i. arranging a pump module to be connected to a mouthpiece designed for a tooth whitening treatment;
configuring a treatment setting on a control device coupled to the pump module;
selectively applying a gum protector device to the gingival ridge, wherein erupted teeth remain substantially exposed at the gingival ridge;
applying flow control to form a vacuum fluid seal between the oral member and the patient's gingival ridge anatomy; and
v. applying flow control to automatically manage delivery of material in accordance with the treatment settings and/or using a flow control module to remove treatment material from the mouth piece.
22. A method as set forth in claim 21 including the step of monitoring treatment to track compliance with a treatment plan.
23. The method of claim 21, wherein the method includes the step of monitoring treatment to identify problems during treatment.
24. The method of claim 23, wherein the therapeutic material differs in temperature of the material, concentration of the material, or both.
25. The method of claim 21, for performing a tooth whitening treatment.
26. An apparatus, comprising:
a. a deformable selectively resilient gum ridge sealing portion for covering the gum ridge;
b. a pair of distal tooth seal portions, wherein the gum ridge seal portion and the distal tooth seal portion define a gap between at least a portion of the device and a tooth and a surrounding gum ridge, wherein at least a portion of the device is positioned over the tooth and the surrounding gum ridge; and
c. at least one fluid conduit portion for passing fluid into or out of the treatment cavity;
wherein, when the device is placed in a patient's mouth, over a plurality of teeth, the gum ridge seal portion contacts and deforms against the patient's gum ridge for making intimate contact with the gum ridge, and the pair of distal tooth seal portions deforms against one or more teeth located distally to substantially define a seal at the distal teeth, such that fluid can be introduced into, removed from, or both while the treatment cavity remains sealed by the deformable gum ridge seal member and tooth seal member, and
wherein the deformable gum ridge seal portion comprises one or more hardened portions for enabling selected/different collapsibility when exposed to vacuum pressure.
Technical Field
The apparatus and method of the present invention relate to dental treatment and more particularly to tooth and gum treatment.
Background
The anatomical regions behind the end teeth on the left and right sides of the upper or lower jaw are called post-molar bite pads. Tray appliances are typically manufactured to cover these end teeth, and the end boundaries of these end teeth are post-molar tooth pads. There is significant variation between patients in their tooth size and their arch shape. With respect to manufacturing a tray to properly cover all of the teeth contained within any given arch, consideration must be given to the variable width and length of the arch.
The user is instructed to fill the full arch tray with a mild whitening chemical (gel) and place the tray on the teeth for several hours per day for a period of at least one to two weeks. The custom tray covers all teeth in the upper or lower jaw. This means that the user can simultaneously whiten the anterior and posterior teeth using this treatment method using one tray for the upper teeth and one tray for the lower teeth.
It has been demonstrated that natural saliva in the oral cavity contains peroxidases that naturally break down and neutralize hydrogen peroxide (Tenovuo and Pruitt, 1984). The use of a custom professional whitening tray, which conforms more closely to the teeth than an over-the-counter stem whitening tray, reduces the amount of saliva that can penetrate into the tray and come into contact with the active hydrogen peroxide that has been placed into the tray. This reduces the amount of inactivation or breakdown of the active gel by saliva and thus increases the chemical whitening effect of this professional whitening treatment compared to non-prescription "stock" whitening trays, which do not adapt well to the teeth and thus allow a large amount of saliva to leak into these trays.
The custom "whitened" tray appliances of the above-mentioned "home" treatment methods require two dental examinations. During the first visit, a dental impression of the dental arch is taken at the dental clinic and a custom fitted thin plastic "whitened" dental tray of rigid or semi-rigid is then manufactured from the dental impression. The outer limiting surfaces of these trays can be closely fitted to the teeth or made much larger than the teeth. The "in-home" treatment method described above requires the user to spend considerable time (as described above) to achieve moderate tooth whitening, and often results in the teeth becoming sensitive and the gum and oral mucosal tissue becoming irritated or chemically burned due to the prolonged exposure of the teeth and gums to the whitening agent. Many patients find the effort required to achieve adequate "whiter teeth" results too laborious and often present a very high rate of noncompliance, resulting in poor final tooth whitening.
These significant drawbacks in professional "home" whitening treatment methods have led in recent years to professional dental treatments known in the dental field as "in-office" treatments or "intensive whitening" treatments. This treatment method involves the use of a dental professional in a dental clinic and administering under the supervision of the dental professional a formulation that is more highly concentrated (and more caustic) than the various tooth whitening chemicals previously used for "home" whitening treatments. To protect the gingival tissue from these highly concentrated whitening agents, it can be manually applied (very time consuming) using a "dam lacquer" or protective coating (a layer of material applied in the form of a strip at the gum line that is positioned in a fan shape to outline the gum line) and hardened with a standard dental Ultraviolet (UV) lamp. Additionally, uncomfortable lip and cheek retractor devices are inserted into the mouth along with the cotton rolls (and gauze, if needed) in an attempt to protect the remaining oral tissues of the mouth from these highly concentrated and corrosive whitening agents.
These precautions are necessary because contact of these highly concentrated chemical whitening agents used in "intensive" whitening with the above-mentioned soft tissues of the mouth will cause significant chemical burns and pain to the patient in a few seconds. Typically, three applications of whitening agent (about 20 minutes each) are limited to the buccal (anterior) surfaces of only the anterior teeth, with the previous application being washed and aspirated off the teeth and replaced with the next application. The lingual (interior) surfaces of these anterior and posterior teeth are not all "whitened" using this technique. The "brute force" whitening technique does not use any type of dental tray device. The whitening agent is applied in an open-coated manner on the outer buccal surface of the limited teeth to be treated and therefore does not have the whitening advantage of the compressive effect of whitening gels using dental trays (home whitening technique) as previously described.
Over the past two decades, in-office "treatments or" intensive whitening "treatments have also been shifted to utilize" light activated "whitening agents over older versions of whitening agents that do not require light activation to enhance the oxidative (whitening) chemical reaction. The light-activated brighteners are chemically formulated to oxidize upon exposure to concentrated, intense light sources that act as catalysts to enhance the chemical oxidation of the brighteners.
There is much debate in the dental field as to whether the use of light activated whitening gels can enhance the chemical whitening effect of these gels. It has been postulated that the heat actually generated by light, rather than light of any particular wavelength, actually increases the chemical activity of and therefore the whitening activity of these whitening gels.
The lighting devices currently used in the dental field are generally only able to reach the anterior part of the mouth, and only after retraction of the lips and cheeks using the device as described above. This is due to the limited natural elasticity of the lips and muscles surrounding the mouth, which limits the number of teeth that can be comfortably and safely retracted and exposed to the light source and highly concentrated "strong" whitening chemicals, while still protecting the soft tissues of the oral cavity from these highly caustic whitening agents.
As noted above, these limitations typically result in "brute force" treatment of up to 10 anterior upper and 10 anterior lower teeth (upper and lower central and lateral incisors, canine teeth, and first and second bicuspids) for up to 20 teeth (typically 28 to 32 teeth in a human mouth). Due to the limitations already mentioned, it is common practice to find that only the top 8 front teeth and the
Another limitation of the treatment area is that, typically, the operator can place a light used in "hard" whitening into the mouth of the patient to illuminate primarily the buccal (anterior or outer) surfaces of the anterior teeth, while illuminating only rarely the lingual (posterior or inner) surfaces of these anterior teeth. It is also extremely difficult for the dentist to apply a "paint-on dam" protective coating at the gum line of the lingual "inner" surface of the anterior teeth, and it is almost impossible for the dentist to isolate the very active tongue with current isolation devices and materials available in the dental field. This means that these sensitive oral tissues are extremely difficult to distinguish from the caustic chemical burns of highly concentrated "strong" whitening agents.
The above explains why whitening of the inner (lingual) surface of the anterior teeth is rarely performed in this technique, and the posterior teeth are not whitened at all in this technique. Furthermore, the "strong" whitening of only the buccal (outer) surfaces of the anterior teeth adversely affects the final overall whitening result, since the natural enamel layer of the teeth (naturally present on both the outer and inner surfaces of all teeth) is naturally somewhat translucent. This allows the "darker" tone "of the inner (lingual) untreated surface of the tooth to" show up "through the" front surface ". This naturally occurring optical effect can impair the ultimate overall whitening effect of these teeth when using current "brute force" whitening treatments.
Advantages of the "in-office" or "intensive" whitening treatment methods over "home" treatment include: a. due to the use of highly concentrated whitening agents, the "in-office" or "intensive" whitening treatment method achieves a faster whitening of the teeth compared to the "home" treatment. This significantly reduces the overall treatment time; b. being done "in the clinic", there are fewer problems with patient non-compliance that are often encountered with longer "in-home" treatments; shorter treatment times tend to minimize irritation or sensitivity of the teeth because the teeth are exposed to these agents over a shorter period of time, although some users do experience tooth sensitivity due to the more concentrated intensity of the chemical oxidizing agents used in the treatment method, and experience the undesirable leakage of small amounts of highly concentrated whitening agent through the protective barrier placed onto the oral tissue by the dentist during "brute force" whitening treatments that are often encountered.
The disadvantages of the "in-office" treatment method compared to "home" treatment include: a. as mentioned above, in contrast to "home" treatments that allow whitening of both anterior and posterior teeth, only anterior teeth can be comfortably whitened by the "in-office" method; b. as noted above, more highly concentrated whitening-oxidizing agent formulations are corrosive to the hard (teeth) and soft (gums, oral mucosa, tongue) tissues of the mouth and therefore require the application of special manually applied gingival and oral mucosal barriers by the dental professional under the supervision of the dentist or by the dentist himself on the gingival and oral mucosal tissues in the area to be treated to protect the gingival and oral mucosal tissues from these highly concentrated whitening chemicals. This is a time consuming process, often requiring reapplication during treatment to properly protect the soft tissues of the mouth from these highly concentrated whitening agents. As mentioned above, even with all such isolation in effect, some leakage and burning of the patient's oral tissues is often observed, resulting in temporary pain and discomfort to the patient; c. due to the inaccessibility of the posterior teeth and the difficulty of the posterior region of the oral cavity (due to the cheek and tongue), these whitening treatments are always confined or limited to the anterior portion of the oral cavity (due to the extreme difficulty in protecting the soft oral tissues around the posterior periodontal pocket); d. whitening primarily the anterior (buccal) surface of the anterior teeth and only rarely for the inner (lingual) surface of the anterior teeth; a more pronounced "rebound" effect (reduced whitening effect) is generally observed after treatment with the "in-office" treatment method compared to the "in-home" treatment method. This is due to the short duration of treatment (compared to the much longer treatment times of "home" treatment methods) and the resulting rehydration of the teeth after treatment ("intensive" whitening processes tend to temporarily dehydrate the teeth, which temporarily enhances the initial whitening result). This means that the typical final "whitening" result using the "brute force" whitening technique is much worse than can be achieved when the patient is highly compliant and properly uses the "home" whitening technique.
Disclosure of Invention
According to embodiments of the present invention, devices, methods and systems are provided for assisting in tooth whitening, tooth desensitization, anti-caries, oral hygiene, gum treatment, and the like. The apparatus may include an oral component, one or more fluid-tight treatment lumens, and one or more treatment delivery layers, wherein the mouthpiece is adapted to perform a dental treatment, the one or more fluid-tight treatment chambers have a vacuum below ambient pressure, wherein each dental overlay comprises a layer on the upper teeth and the surrounding gums and/or a layer on the lower teeth and the surrounding gums, the treatment delivery layer having one or more flow channels in fluid communication with the treatment cavity, such that the treatment delivery layer can deliver and/or remove one or more treatment fluids in an optionally high volume amount to and/or from the treatment lumen, and wherein each dental stock layer comprises one or more hardened portions for achieving a selected/different collapsibility when the mouth piece is exposed to vacuum pressure.
In some embodiments, the dental overlay vacuum is created using a continuous or selectively sustainable sealing mechanism comprising a body of the device comprising a sealing rim or skirt (peripheral roll border) formed of a compressible material that incorporates one or more sealing plugs at the posterior opening of each dental overlay in its design, wherein the continuous sealing mechanism substantially seals each of the treatment areas that cover the recessed or partially recessed gingival ridges of the upper and/or lower jaws of the mouth.
In some embodiments, the dental overlay (soft body of the mouthpiece device) is made of a soft, resilient material that easily collapses and can easily conform to closely conform to the varying topography of the gum ridge anatomy.
In some embodiments, the mouthpiece may include one or more stiffening portions that serve as an outer frame coupled to the soft mouthpiece.
In some embodiments, the mouthpiece may include one or more stiffening portions that act as an inner frame embedded or semi-embedded in the soft mouthpiece.
In some embodiments, the dental overlay incorporates stiffening elements on both the buccal and lingual/palatal sides of the overlay. These rigid elements are designed to resist collapse (when a vacuum force is applied to the inner treatment lumen of the covering) of a particular area of the covering to which the rigid elements are attached or embedded/semi-embedded (either externally as an "outer frame" or internally as an "inner frame") in order to create a covering layer (soft body) that can collapse/conform to varying degrees to the gingival ridge covered by the covering layer when inserted into the mouth. This allows the cover layer to fit tightly (by collapsing and being sucked onto the gum ridge) at its peripheral rolled boundary edge or skirt section to the gum ridge and provides a good vacuum fluid seal of the cover against the sides of the upper gum ridge and/or lower gum ridge while against those areas where the rigid stiffening element of the cover layer is attached to resist collapsing and maintain a negative space between the teeth and the surrounding gums covered by the soft body of the cover layer.
This unique design of the mouthpiece device of the present invention allows a large amount of therapeutic material to flow within the treatment cavity of the soft body of the covering (on both the buccal and lingual/palatal sides of the soft body covering), and remains present on the surface of the teeth and the surface of the surrounding gums when a vacuum force is applied to and maintained relative to the mouthpiece, wherein the teeth and surrounding gums are covered by the covering and contained within the treatment cavity.
The unique design of the oral component allows the therapeutic material to flow under positive pressure into the oral component treatment chamber while maintaining a fluid seal to the gingival ridge around the peripheral rolled border of the oral component and maintaining a firm negative space for the therapeutic fluid to completely cover the teeth and/or surrounding gums throughout the treatment period. .
In some embodiments, these rigid reinforcing elements may be embedded or semi-embedded (internally or partially internally as an "internal frame") into the cover layer (e.g., the cover layer may be overmolded onto the rigid reinforcing elements as is known in the art).
In some embodiments, these embedded or semi-embedded rigid reinforcing elements may be connected to each other as a single component to facilitate overmolding. This helps to clamp and secure the inner frame to the mould and prevents the inner frame from being displaced from its position inside the mould as it flows into the mould in the soft overmoulding material of the mouth piece.
In some embodiments, the sealing mechanism is adapted to prevent saliva from entering the treatment cavity and to prevent the treatment material from leaving the treatment cavity.
In some embodiments, the treatment delivery layer comprises one or more heaters within (or inserted into) the treatment delivery layer for heating the treatment material, for heating at least a portion of the treatment lumen, or for heating at least a portion of the treatment lumen and the treatment material.
In some embodiments, the device includes a handle integral with the treatment delivery layer, the handle adapted to: inserting one or more dental overlays onto the upper and surrounding gums and/or the lower and surrounding gums, adjusting the position of the one or more dental overlays, removing the dental overlays after the dental treatment is completed, or any combination thereof.
In some embodiments, the device comprises a power cord for delivering electrical current to (or inserted into) the treatment delivery layer and one or more tubes for delivering and/or removing one or more treatment materials to and/or from the treatment delivery layer, the handle comprising the power cord or both the power cord and the one or more tubes.
In some embodiments, the dental overlay substantially covers the gingival ridge, as previously described.
In some embodiments, the device comprises two dental coatings for covering the upper and surrounding gums and the lower and surrounding gums and at least one treatment delivery layer interposed between the two dental coatings to enable the upper and lower teeth to be treated simultaneously, wherein the device comprises one or more respiratory vents located in the treatment delivery layer and adapted to provide air access to the mouth during dental treatment.
In some embodiments, the handle includes one or more inflow tubes for flowing one or more therapeutic materials into the treatment delivery layer and one or more outflow tubes for flowing one or more therapeutic materials out of the treatment delivery layer.
In some embodiments, the mouthpiece may include one or more delivery apertures for flowing the treatment material from the treatment delivery layer to the treatment lumen and one or more discharge apertures for flowing the treatment material from the treatment lumen to the treatment delivery layer, and wherein the treatment delivery layer includes one or more delivery channels for delivering the treatment material from the inflow tube to the treatment lumen and one or more discharge channels for delivering the treatment material from the one or more discharge apertures to the outflow tube.
In some embodiments, the dental overlay includes one or more compressible rear cavity plugs adapted to seal the cavity to prevent material from flowing out of the rear side of the vacuum-formed overlay.
In some embodiments, the device comprises one or any combination of the following design features: the dental overlay incorporates a highly compressible peripheral rolled border skirt or edge to conform to the gingival ridge; the treatment delivery layer includes one or more independently controllable heating elements within (or inserted into) the treatment delivery layer; the dental treatment layer is located between the upper and lower dental overlays and the mouth piece is shaped to reflect the hinge axis angle to facilitate natural jaw movement.
In some embodiments, the vacuum fluid seal is formed via the treatment delivery layer by reducing the pressure in the dental treatment cavity below ambient pressure.
In some embodiments, the device includes the ability to flow water or a water/air mixture or air alone into the treatment cavity between each application of the gel. This allows the teeth and surrounding gums within the treatment cavity to be cleaned and dried at the end of each application of the treatment material (fluid or gel).
In some embodiments, the device may include a pumping system for pumping one or more treatment materials into the inlet component, a multi-position flow control module, and a control unit for automating the dental treatment.
In some embodiments, the device enables automation of the treatment, i.e., an automated number of cycles including the administration of the treatment material (fluid or gel), followed by a wash/dry cycle, and then a variable number of cycles of wash/dry cycles may be automatically repeated for each treatment.
In some embodiments, the device includes a disposable elastic dental gingival guard barrier member for providing additional protection from the treatment material without compromising the device's ability to enable a vacuum fluid-tight treatment cavity for the flow of treatment material into and removal of treatment material from the treatment cavity without any leakage of the material, wherein the treatment material may be inserted over the gingival ridge and covered by the mouthpiece device.
In some embodiments, the device includes a disposable dental gingival guard barrier component including a gingival treatment layer on an inner surface thereof for delivery of one or more therapeutic materials to the gingiva.
According to some embodiments, a dental gingival guard barrier is provided that may include a flexible elastomeric arch wrap designed to substantially conform to the gingival ridge anatomy and having a pre-configured incised aperture for custom insertion over and through teeth for providing a fluid-tight dry zone, wherein the separate aperture circumferentially tightly encases an erupted anatomical crown portion of the teeth at the gum line location of the teeth such that the erupted portion of the teeth remains substantially exposed when the teeth are inserted through the aperture, and the barrier provides a substantially fluid-tight barrier around the gingival ridge it covers (and included between the exposed teeth).
Dental gingival guard barriers have separate incision holes through which the crown portions of erupted teeth are inserted, characterized in that the barrier material between teeth in the interproximal spaces between the teeth is called an interproximal tension dental bridge. These bridges allow a tight circumferential fit of the wrap around the "neck" (at the level of the cementum-enamel junction of the tooth) or more commonly the level of the gum line of the tooth.
This tight circumferential fit provides an effective fluid-tight barrier to protect the gingival tissue covered by the barrier from even high concentrations of peroxide gel. This tight circumferential fit also provides a substantially fluid seal of the barrier to the gingival ridge so that the therapeutic material or drug placed under the barrier and on the gingival tissue or delivered into the sulcus (gingival pocket) of healthy or diseased gingival tissue will remain in place while not being affected by saliva dilution and irrigation. This functionality of the gum protector barrier increases the therapeutic window of action of the therapeutic material or drug positioned under the barrier and can directly affect the efficacy of the material or drug to heal gingival tissue.
In some embodiments, the disposable dental gingival guard barrier includes a layer of therapeutic material on one or more surfaces, wherein the therapeutic material is adapted to neutralize the therapeutic material.
In some embodiments, the disposable dental gum protector barrier incorporates an internal channel within the dental gum protector barrier on its buccal, occlusal and lingual/palatal sides, the internal channel being pre-filled with a light curable resin material. When inserted and seated onto the gingival ridge (by inserting a tooth hole through an anatomical crown portion of the tooth), the gum protector barrier can be tightly adapted to the patient's specific gingival ridge anatomy by pressing and molding the barrier to the underlying ridge on both its buccal and palatal/lingual sides and polymerizing and curing the light curable material contained within the channels of these respective faces of the barrier in order to more closely conform the barrier to the specific ridge it covers. Additionally, the channel of the barrier pre-filled with a light curable resin material may extend (when inserted onto the gum) into the natural anatomical undercut of the gum ridge (e.g., the oral mucosal fold as an example).
When the barrier is stretched and pressed into these natural undercuts of the gum ridge and the resin is cured in place, the stiffening channel seated in the gum ridge undercut creates a mechanical anchor for the new location of the barrier.
The boundaries of the individual perforations can also be stretched by stretching the barrier into the undercut of the gum ridge (since the boundaries of the individual perforations are all integral with the wrap structure), and each of the boundaries of the individual perforations can thus be adjusted to a new position as determined by the operator and "frozen" by the operator to more closely conform to the patient's particular gum line (on a tooth-by-tooth basis). This is advantageous in whitening teeth because it allows selective complete exposure of all of the enamel surface of the teeth to the whitening material applied to the teeth while effectively protecting the surrounding gums of the gingival ridge contained within the mouthpiece and exposed to the high concentration of peroxide treatment fluid/gel.
In a further embodiment, there is provided a method for performing a dental treatment, the method comprising: positioning a mouthpiece comprising one or more dental overlays on the upper teeth and the surrounding gums and/or the lower teeth and the surrounding gums; applying a vacuum to the selectively deformable/collapsible dental overlay such that a fluid-tight treatment cavity at a pressure below ambient pressure is formed around the teeth and surrounding gums; and flowing one or more treatment materials into the fluid-tight treatment cavity.
In some embodiments, the method comprises one or any combination of the following steps: arranging a pump module to be connected to a mouthpiece designed for a tooth whitening treatment; configuring a treatment setting on a control device coupled to the pump module; applying a flow control module to create a vacuum between the oral member and the patient's gingival ridge anatomy; inserting one or more gum guard barriers over and through an anatomically erupted crown portion of a tooth to substantially cover and fluidly seal the gingival anatomy surrounding the tooth; and applying a flow control module to automatically manage delivery of the material in accordance with the treatment setting and/or using the flow control module to remove the treatment material from the mouthpiece.
In some embodiments, the method includes the step of applying flow control to change the flow pattern during treatment to optimize compliance with the treatment plan, as previously indicated.
In some embodiments, the method includes the step of monitoring the treatment to track compliance with the treatment plan.
In some embodiments, the method includes the step of monitoring the treatment to identify problems during the treatment.
In some embodiments, the therapeutic materials differ in temperature of the material, concentration of the material, type of material, viscosity of the material, or any combination thereof.
According to some embodiments, the therapeutic device may be an inventory item that may provide several inventory sizes, and the inventory item may be a reusable or disposable item that may include a single arch or double arch mouthpiece, wherein a breathing tube is incorporated into the body of the device that allows the patient to breathe through the mouth when the double arch mouthpiece is inserted into the oral cavity. The mouth piece apparatus has a flexible sidewall with a highly collapsible circumferentially deformable skirt or rolled boundary that fits over the upper and lower alveolar ridges of the mouth. Each arcuately formed treatment cavity contains a rear sealing plug feature at its distal end (right and left). The plug is made of a highly deformable material that, when bitten, closely conforms to the anatomy of the crown section of the tooth being bitten into. The plug in combination with the easily deformable (collapsible when vacuum force is applied to them) circumferential peripheral rolled boundary edge of the device allows the mouthpiece device to closely conform to the upper and lower alveolar ridges and to create a tight continuous or selectively sustainable fluid seal of the mouthpiece to these structures when vacuum force is applied to the device via the feed layer.
As previously mentioned, the rigid elements of the device are designed to prevent collapsible deformation of those areas of the device that correspond internally to the treatment cavity surrounding the teeth and directly surrounding the gums, to maintain an internal negative space around the teeth and around the gums as the treatment material flows into the teeth and around the gums, while a vacuum force has been applied to the device and a fluid seal has been achieved with respect to said treatment cavity.
The mouthpiece device further incorporates in its intermediate layer a plurality of flow channels having outlets and inlets, and one or more heating elements (one or more heating elements may also be inserted in the flow channels), the temperature of which may be independently controlled by a microprocessor unit contained within the control unit. In some embodiments, the heating elements may comprise a helical metal member covered by a metal tube. The spiral metal part may be hollow and contain an electrical heating element which, when electrically heated, conductively heats the surrounding metal element.
The treatment material flowing through the jacketed helical member will be conductively heated as it flows directly through the jacketed heating helical element. A printed circuit board (which may be flexible) may be incorporated to provide temperature control of the heating element and thus control the resulting heating temperature of the gel flowing through the heating module and out of the heating module.
In some embodiments, the entire heating module unit may be nested within a housing (of plastic or other suitable material) to allow for comfortable handling of the heating module unit as it is heated.
The microprocessor unit may control electrical power, duration, alarms, sensors, single or multiple heating elements, pumps, motors and other control devices. As previously noted, several different types and sizes of disposable, customizable or inventoried individual gum protector/guard elements can be inserted into the port prior to insertion into the port and used in conjunction with the device without compromising the device's ability to form and maintain a fluid-tight treatment cavity.
The pump member may be used to create a vacuum within the treatment cavity of the mouthpiece device. Different therapeutic materials in different concentrations may be delivered in a controlled manner via the pump and flexible tubing connected to a heating module unit that is fluidly connected to the mouthpiece device.
A pressure sensor is integrated with the system to monitor the volume and flow rate of the gel and the vacuum seal integrity of the port member in the port while the therapeutic material is delivered into the port member. Whitening gel may similarly be removed from the device by the system in a controlled manner. Similarly, fresh water or a mixture of water and air or air can be delivered to and removed from the mouthpiece device separately to rinse or wash away any remaining gel residue from the teeth and dry the teeth and/or surrounding gums and the inner surface of the treatment cavity of the mouthpiece after each gel application.
An optional tooth shade matching sensor unit for recording the tooth shade values before and after treatment may be incorporated into the control unit.
According to various aspects of the present invention, an apparatus for providing dental treatment may include: a deformable gingival sealing portion for covering the gingival ridge; a pair of distal tooth seal portions, wherein the gum seal portion and the distal tooth seal portion define a gap between at least a portion of the device and a tooth on which the device is positioned; and at least one fluid conduit portion for fluid to enter or exit the treatment cavity, wherein, upon placement of the device in the mouth of a patient, on the plurality of teeth and surrounding gums, the gum seal portion contacts and deforms against the patient's gum ridge to form a tight contact with both sides of the gum ridge, and the distal tooth seal portion deforms against the teeth at the distal end to substantially define a seal at the distal end of the one or more teeth, such that fluid can be introduced into, removed from, or introduced into and removed from the treatment cavity while the treatment cavity maintains a fluid seal through the deformable gum seal and tooth seal upon application of a vacuum force to the device.
Drawings
The principles and operation of a system, apparatus and method according to the present invention may be better understood with reference to the drawings and the following description, it being understood that these drawings are given for illustrative purposes only and are not meant to be limiting, in which:
FIG. 1a is a side view of one embodiment of a
FIG. 1b is a front view of a mouthpiece according to some embodiments;
FIG. 2a is a top/front view of FIG. 1a according to some embodiments;
FIG. 2b is a top/rear view of FIG. 1a according to some embodiments;
FIG. 3a is a top/back view of the
FIG. 3b is a bottom/rear view of the
FIG. 4a is a top close-up view of FIG. 1a, according to some embodiments;
FIG. 4b is a rear view of the
FIG. 5a is a bottom view of one embodiment of a
figure 5b is an angled front view of the
figure 5c is a rear view of the
FIG. 6a is a front view of one embodiment of the
figure 6b is a side view of the
FIG. 7 is an exploded view of an embodiment of components of the
FIG. 8a is a side view of an embodiment of a
fig. 8b is a side view of an embodiment of the
figure 9 is a flow chart describing an example of a process for implementing gum treatment using a mouthpiece and associated components as described herein, according to some embodiments;
fig. 10 is a flow chart describing an example of a process for implementing a tooth whitening treatment using a mouthpiece, gum guard and associated components as described herein, in accordance with some embodiments;
fig. 11a is a front view of an
fig. 11b is a top view of the
fig. 11c is a top view of an inner frame reinforcement element according to some embodiments.
It will be appreciated that for simplicity and clarity of illustration, elements illustrated in the figures have not necessarily been drawn to scale. For example, the dimensions of some of the elements may be exaggerated relative to other elements for clarity. Furthermore, a certain number of elements have been described according to certain embodiments, however other embodiments may be provided with fewer or more elements, such as holes, pins, heating elements, tubes, etc. Further, where considered appropriate, reference numerals may be repeated among the figures to indicate corresponding or analogous elements throughout the sequential views.
Detailed Description
The following description is presented to enable one of ordinary skill in the art to make and use the invention as provided in the context of a particular application and its requirements. Various modifications to the described embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments. Thus, the present invention is not intended to be limited to the particular embodiments shown and described, but is to be accorded the widest scope consistent with the principles and novel features disclosed herein. In other instances, well-known methods, procedures, and components have not been described in detail so as not to obscure the present invention.
Preferred dental treatments employ one or more chemicals, drugs, or other treatment-related materials that interact with the teeth and/or gums, optionally in low, medium, or high volume. Embodiments of the present invention enable increased efficiency and effectiveness of dental treatment by applying a vacuum to a mouthpiece comprised of a soft collapsible material and a stiffening portion that resists collapse. Such embodiments enable the delivery of a selectively engineered or designed sealed treatment cavity or region in which treatment materials may be optimally applied and which may also prevent the escape of treatment materials outside of the sealed treatment cavity. Non-limiting embodiments of the present invention include tooth treatment devices or apparatuses, methods and systems in which tooth whitening, gum treatment, tartar removal, tooth desensitization, anti-caries and other treatments can be delivered to one or more selected target treatment chambers and to hard or soft tissue contained therein.
Embodiments of the present invention include a dental treatment mouthpiece that may include a single or double layer arch covering. The oral component may include one or more dental overlays for covering the upper teeth and the surrounding gums and/or the lower teeth and the surrounding gums. The dental overlay is preferably an arch, such as an arch, configured to fit over the lower or upper teeth and the corresponding surrounding gums. For example, the mouthpiece may include an upper dental covering and a lower dental covering (e.g., the mouthpiece may include a double arch). The dental overlay can have an arch treatment cavity that covers the teeth and surrounding gums. A particularly preferred mouthpiece comprises two dental overlays, each having an arch treatment cavity, wherein the two dental overlays are co-joined to form a single device. It will be understood that two co-joined dental overlays may be joined via one or more additional layers, such as one or more treatment delivery layers, in accordance with the teachings herein.
Mouth pieces according to some embodiments of the present invention allow for the use of generic or stock deformable mouth pieces in a patient so that the variable width and length of the patient's full arch can be handled without the need to make custom mouth pieces for each patient. When such an inventory mouth piece is used, embodiments of the present invention enable the maintenance of a continuous vacuum fluid seal of the mouth piece with respect to a given arch gingival ridge to which the mouth piece is placed. The distal plug of the mouth piece is highly deformable so that when the patient is instructed to bite down into the mouth piece, the plug will tend to deform around the crown section of the end tooth or teeth. This close fit of the improved mouth piece of the present invention to any given arch is independent of the length and width of the arch to which the mouth piece is to be fitted, and independent of the position of the right or left end teeth of any given arch relative to their respective post-molar bite pads.
The dental treatment mouthpiece may be reusable or disposable after a single use. The mouthpiece may be constructed in a variety of common or stock sizes (e.g., small, medium, large, oversized), or may be customized to cover the upper teeth, lower teeth, and corresponding surrounding gums of the gingival ridge. The mouth piece may comprise one or more heating elements inserted therein for heating the dental treatment fluid or material and for heating the treatment fluid material before it flows into the mouth piece, optionally using in-line direct conduction heating provided by a heating module unit fluidly connected to the mouth piece device of the present invention.
The apparatus may be used in a system comprising one or more control units, such as in a control unit comprising a microprocessor. The control unit may be an external control unit. The control unit may control the temperature of the one or more heating elements. The control unit may control the oral member with double arches each having an arch treatment cavity such that simultaneous treatment of the upper teeth, the lower teeth and/or the respective surrounding gums is controlled.
The dental arches of the dental oral components (e.g., each arch of a co-engaged dual arch oral component) preferably have a dental overlay with an arch-shaped well or other design suitable for forming a treatment cavity that can contain one or more dental treatment fluids. For example, the arch well treatment cavity may contain a dental fluid containing a predetermined concentration of an active ingredient. The active ingredient may be any chemical suitable for whitening teeth in situ or for other dental treatments. Particularly preferred active ingredients for tooth whitening include, for example, one or more peroxides. The active ingredient may be activated or otherwise have a reactivity that is accelerated or enhanced (e.g., catalyzed or otherwise) by heating. A therapeutic fluid (e.g., a therapeutic fluid containing an active ingredient) can be delivered into the treatment lumen portion of the oral component via a pumping system (e.g., an automated pumping system), a vacuum, or both a pumping system and a vacuum. Preferably, the treatment fluid substantially covers a natural crown portion of a tooth (e.g., a tooth undergoing treatment) when in the treatment cavity. Alternatively, the treatment fluid, when in the treatment cavity well, may also substantially cover the portion of the gingival tissue surrounding the crown portion of the tooth (e.g., the gingiva undergoing treatment).
A sealed compartment surrounding the teeth and surrounding gums formed by the treatment cavity well of the dental overlay (i.e., a sealed treatment cavity) may be used to deliver one or more treatment materials to the erupted crown portion of the plurality of teeth. For example, a series of two or more different therapeutic fluids or cleaning/washing fluids or air streams may pass through the sealed compartment. Without limitation, the therapeutic fluid may include one or more preparation fluids, one or more active therapeutic fluids, one or more drugs, one or more neutralization fluids, one or more rinse fluids, an air stream combined with a rinse fluid or an air stream used alone for drying, or any combination thereof. Preferably, the therapeutic fluid includes one or more of a whitening therapeutic fluid, a rinsing fluid, a drug, or other therapeutic material. The whitening therapeutic fluid may include, for example, any active ingredient known in the art for whitening teeth and/or any inactive ingredient. Without limitation, whitening therapeutic fluids may include, for example, U.S. patent No.7,189,385 (see, e.g.,
One or more therapeutic fluids may be heated to reduce viscosity, increase reactivity, or both. For example, increasing the temperature of a treatment fluid such as a whitening agent (hereinafter referred to as a gel, although high viscosity fluids may be used in accordance with the teachings herein) may increase the rate of peroxide decomposition to generate oxygen radicals from the gel, and thus may increase the resulting whitening effect in the enamel surface of the teeth. Of course, other therapeutic materials may be used, including water, salts, gases, chemical and/or biological drug solutions, or other materials, compounds, and the like. Each treatment cavity (e.g., arch-shaped treatment cavity) of the dental overlay can contain one or more inlet holes for delivering treatment material into each treatment cavity and an outlet (i.e., discharge) hole (e.g., one or more outlet holes on each of the right and left sides of the treatment cavity in the arch-shaped cavity) for removing treatment material from each arch treatment cavity.
The components, devices, systems and methods according to the teachings herein may be advantageously used in various dental treatments, such as in accelerated whitening treatments, deacidification treatments, gingival treatments, and the like. By using low and high volumes of therapeutic fluids (e.g., whitening fluids such as whitening gels, drugs, therapeutic materials, etc.) with high temperatures, high concentrations, or both high temperatures and high concentrations of active ingredients, the efficiency of therapy can be increased such that therapy is accelerated and/or enhanced. It will be appreciated that the whitening treatment may be achieved without the need for photodynamic therapy, for example. Accelerated dental treatment may be achieved by heating the dental treatment fluid. Although room temperature therapy may be employed, it is preferred that some or all of the therapeutic fluid be heated to a temperature of about 27 ℃ or greater, more preferably about 30 ℃ or greater, even more preferably about 34 ℃ or greater, even more preferably about 38 ℃ or greater, even more preferably about 48 ℃ or greater, most preferably about 56 ℃ or greater. Of course, higher or lower temperatures may be used as desired. The treatment fluid in the treatment region (i.e., in the sealed treatment cavity formed by the dental overlay) may have a substantially uniform temperature or may have a varying temperature. It will be appreciated that similar increases in treatment rate may be achieved using higher concentrations of active ingredient in the treatment fluid.
The dental overlay preferably has a circumferentially peripheral rolled boundary edge formed of a sufficiently soft material and arranged such that the rolled boundary edge will compress and deform to closely abut against the sides of the gingival ridges of the maxilla and mandible. Thus, the rolled boundary edge may form a sealed cavity (e.g., formed by a cavity well of a dental overlay) in which the erupted crown of the tooth and the surrounding gums are contained.
The improved mouthpiece of the present invention may incorporate one or more air breathing vents. Preferably, the breathing vent is designed to penetrate the treatment delivery layer of the port member without compromising the ability of the treatment delivery layer to flow one or more treatment materials into a treatment cavity well (e.g., an arch cavity well) of the dental overlay, without compromising the ability of the treatment delivery layer to drain one or more treatment fluids from the dental overlay, or without compromising both. For example, a respiratory vent may be integrated with a therapy delivery layer in a manner that allows one or more therapeutic fluids to flow into and out of the flow components.
The sealing coil boundary edges, preferably made of a soft deformable material, may be in a generally circular shape, such as the shape of a skirt that is formed to be extremely deformable, so that when a vacuum force is applied to the inside of the mouth piece, act to collapse these coil boundaries onto the gingival ridge and fluidly seal the mouth piece device (e.g., dental overlay) of the present invention against the gingival ridge. The seal may preferably be achieved partially or completely by the patient biting down on the mouthpiece. The sealing rim can effectively seal the treatment cavity well of the dental overlay such that treatment material (i.e., treatment fluid) delivered to the oral component is prevented from leaking into the oral cavity. Sealing may be achieved partially or completely by applying a vacuum. For example, when a vacuum is applied, the seal roll boundary edge may easily collapse and be sucked up on the sidewall of the gum ridge. The treatment fluid pumped into the fluid-tight treatment cavity well of the dental overlay preferably contacts the corresponding teeth on the front surface, the top surface, the back surface, or any combination thereof. More preferably, the treatment fluid contacts the teeth on the anterior and posterior surfaces. Even more preferably, the treatment fluid contacts the teeth on all exposed surfaces of the teeth. The sealing effect of the highly deformable skirt and/or sealing the rolled boundary edge may be achieved or enhanced by the ability of the treatment system to remove (e.g., suck out) air within the mouthpiece with an external pump to achieve a vacuum fluid seal of the mouthpiece against the upper and/or lower gingival ridges of the upper and/or lower jaw.
Due to the large variation in length of the dental arch between individuals, it may be difficult or even impossible to effectively use a common stock arch to seal the rearmost area of the well of the dental overlay. For example, it may be difficult or impossible to effectively seal the area corresponding to the distal right and/or left teeth in any given arch. Without sufficient sealing in these areas, the therapeutic fluid may undesirably leak out of one or more sides (i.e., right, left, or both) of one or both of the upper or lower arch-shaped wells through these large unsealed openings. Such unsealed openings (i.e., unsealed areas) may also prevent the creation and/or maintenance of a vacuum seal of the dental treatment cavity well without providing some means for sealing these open areas. Forming a vacuum seal between the dental overlay and the post-molar pad may encounter obstacles such as having to select or prepare a dental overlay of sufficient length and possibly contacting the soft tissue of the post-molar pad with the treatment fluid. To overcome these obstacles, the vacuum seal in the back of the dental overlay is preferably made with molars on each side of the arch. While this may limit the ability to provide dental treatment to one or more molars, the above-described benefits often outweigh this problem. However, the need to form an adequate seal (e.g., for maintaining a vacuum) may present particular challenges when sealing on a molar. Surprisingly, an adequate seal has been achieved using a unique distal plug feature incorporated into the rear region of the treatment lumen well.
To prevent such leakage of the therapeutic material and to allow the ability to create and maintain a continuously or selectively maintained vacuum in the mouthpiece, various teachings of the present invention may incorporate one or more distal plug features (i.e., distal sealing plugs). The term "selectively maintain a vacuum" may refer to the ability of the user or practitioner to determine how long to maintain a vacuum during treatment, multiple activations and releases of a vacuum, and the like. Preferably, distal plugs are used at both ends (right and left) of each dental overlay. The distal plug may be designed to cover a rear portion of the treatment cavity well of the dental overlay. Preferably, the distal plug effectively seals the openings. For example, the distal plug may seal the opening when the patient bites down on the mouthpiece. In some embodiments, distal plugs of various sizes (e.g., height and length) may be incorporated into the design of the mouthpiece.
Each arch mouth component device includes one or more treatment delivery layers. The treatment delivery layer may provide one or more treatment fluids to the dental overlay, may provide heat to the dental overlay, or both. If the mouthpiece comprises two dental overlays, each dental overlay may have a separate treatment delivery layer, or both dental overlays may employ a single treatment delivery layer. For example, a single treatment delivery layer may be positioned between two dental overlays. The therapy delivery layer may contain built-in flow channels or tubes that enable one or more therapeutic fluids to flow. Preferably, the flow channel or tube of the therapy delivery layer extends through this layer of the oral component. The treatment delivery layer preferably has one or more (e.g., two or more) inlet holes for delivering fluid to a well (e.g., a sealed cavity) of the dental overlay. The treatment delivery layer preferably has one or more (e.g., two or more) outlet holes for removing fluid from the pores (e.g., sealed cavities) of the dental overlay. It will be appreciated that the flow direction may be changed such that the outlet opening may function as an inlet opening, such that the inlet opening may function as an outlet opening, or such that the outlet opening may function as an inlet opening and the inlet opening may function as an outlet opening. The treatment delivery layer serving the upper and lower dental overlays may have (1) one or more holes (e.g., inlet and outlet holes) in the floor of the treatment delivery layer for providing fluid communication with the treatment cavity or well of the dental overlay of the lower teeth and the surrounding gums; and (2) one or more holes (e.g., inlet and outlet holes) in the top plate of the treatment delivery layer for providing fluid communication with the dental overlay on the upper teeth and surrounding gums. The flow channel or tube preferably delivers and substantially evenly distributes one or more therapeutic fluids to the dental overlay. The therapeutic fluid may be any therapeutic fluid known in the art, such as the therapeutic fluids described herein. For example, the therapeutic fluid may include a whitening material (e.g., a gel material), water, air, a pharmaceutical material, a therapeutic material, a cleansing material, a rinsing material, or any combination thereof. The treatment delivery layer may deliver one or any combination of the treatment fluids into a treatment cavity well (e.g., an arch well) of the dental overlay. In this way, the treatment delivery layer can effectively bathe one or more surfaces of the teeth (e.g., all surfaces of the teeth) and the surrounding gums in the well with the whitening gel or other treatment material, and the treatment delivery layer is covered by the dental overlay. Preferably, the channel or tube is capable of delivering and/or removing a variety of therapeutic fluids such as water or air.
The treatment delivery layer of the port member may include a lumen or port for insertion of a heating module unit for controlled heating of the treatment fluid flowing through the heating module unit and then into the treatment lumen of the port member. The treatment delivery layer may be incorporated into the coupling component of the mouthpiece to allow secure insertion of the heating module unit into the coupling and secure fluid connection of the coupling containing the segments of the treatment delivery layer of the mouthpiece to the heating module unit.
The soft body of the covering layer of the mouthpiece may be very soft (e.g., VLRH — very low rubber hardness) to improve patient comfort and wear when inserted into the oral cavity. The soft body of the covering of the mouthpiece can be very soft to facilitate its easy collapse and tight conformity to the side walls of the gum ridge, thereby expanding the range of patients with different gum ridge anatomies to which the mouthpiece rolled boundary edge can be drawn to achieve a good vacuum fluid seal of the mouthpiece to the gum ridge and enhance the ability to achieve an acceptable level of and maintain a good vacuum fluid seal throughout the treatment process, even though positive pressure can be applied within the treatment cavity when flowing in the treatment material inside the treatment cavity of the covering.
The soft body may be made of a silicone material or a thermoplastic elastomer or other elastomeric material of very low shore hardness.
The stiffening elements on both the buccal and lingual/palatal sides of the covering may be incorporated in some embodiments of the mouthpiece. These rigid elements are designed to resist collapse (when a vacuum force is applied to the inner treatment lumen of the covering) of the particular area of the covering to which they are attached (either externally attached as an "outer frame" or embedded or semi-embedded as an "inner frame") to create a covering (soft body) that, when inserted into the oral cavity, is capable of collapsing/conforming to varying degrees to the gingival ridge or ridges covered by the covering. This allows the cover to fit tightly (by easily collapsing and being sucked onto) the gingival ridge at its peripheral rolled boundary edge or skirt section and provides a good vacuum fluid seal of the cover against the sides of the upper or lower gingival ridge and at the same time against those areas to which the rigid stiffening element of the cover is attached to resist collapse and maintain a negative space between the teeth and the surrounding gingiva, which are covered by the fluid-sealed soft body of the cover.
This design of the mouthpiece device of the present invention can allow a large amount of therapeutic material to flow within the treatment cavity of the soft body of the covering (on both the buccal and lingual/palatal sides of the soft body covering), and this design remains present on the surface of the teeth and the surface of the surrounding gums that are covered by the covering and contained within the treatment cavity while a vacuum force is applied to and maintained relative to the mouthpiece.
The design of the oral component may also allow the therapeutic material to flow under positive pressure into the oral component treatment chamber while maintaining a fluid seal to the gingival ridge around the peripheral rolled boundary of the oral component and maintaining a firm negative space for the therapeutic fluid to completely cover the teeth and/or surrounding gums throughout the treatment period. Alternatively, these stiffening elements may be partially or completely embedded inside the covering layer (as "inner frame").
Embodiments of the oral component may incorporate an upper "bite plate" and/or a lower "bite plate" that is inserted or embedded or semi-embedded into the upper and lower plates of the soft covering of the upper and lower treatment lumens, respectively, of the oral component. Embodiments of the mouthpiece may incorporate locating indentations or ridges to optimally locate the teeth and gum ridges inside the mouthpiece, and may also help prevent the patient from biting too hard and collapsing, compromising the lumen integrity of the internal vacuum tube supply layer and compromising the ability to achieve and maintain a vacuum.
Embodiments of the mouthpiece may also incorporate a rigid mouthpiece coupler component that is fluidly connected to the soft cover and the delivery layer. The rigid mouthpiece coupler may also allow it to be fluidly connected to a heating module unit which itself is fluidly connected via a set of tubing with a control unit and a treatment container (or disposable treatment cartridge) insertable into the control unit. The treatment container or the disposable cartridge itself is fluidly connected to the tubing and through this tubing to the heating module unit and the connected mouthpiece device of the present invention.
In some embodiments, the mouthpiece coupler may incorporate rigid vacuum tube extensions (left and right) that are inserted into the vacuum tubes of the delivery layer (built into the soft body of the mouthpiece) to protect the lumen integrity of the vacuum lines when the mouthpiece is inserted into the mouth and the patient closes his upper and lower jaws to insert the upper and lower dentiform or partially dentiform upper and lower gingival ridges into the upper and lower overburden treatment chamber wells.
In some embodiments, the mouthpiece coupler may incorporate a rigid vacuum tube fluidly connected to the heating module unit and to a connected control unit conduit (which is itself connected to the vacuum pump and to a flow control mechanism inside the control unit). In some embodiments, this particular vacuum tube may incorporate a deformable O-ring feature to enhance the fluid seal of the mouthpiece coupler to the heating module unit and to the vacuum tubing line of the control unit.
Components, devices, systems, and methods according to the teachings herein may be used in dental treatment to provide treatment to one or more teeth, to provide treatment to the gums, or to provide treatment to both one or more teeth and gums. These components, devices, systems and methods may find application in tooth whitening, antibiotic treatment, antimicrobial treatment, fluoride treatment, or any combination thereof. It will be understood that other applications in the dental field may find use of the features in accordance with the teachings herein. The dental treatment may be a generally short treatment, such as about 10 minutes or less, or may be a generally long treatment, such as greater than 10 minutes, preferably about 20 minutes or more, more preferably about 30 minutes or more. It will be appreciated that the duration of the dental treatment will generally be about 3 hours or less, more preferably about 2 hours or less, and most preferably about 1 hour or less. Dental treatments having a duration of greater than 3 hours are also contemplated (e.g., from about 3 hours to about 8 hours, such as during nighttime sleep hours). The vacuum may be applied to the dental overlay for a majority of the treatment time (e.g., at least 50% of the duration, at least 70% of the duration, at least 80% of the duration, or at least 90% of the duration). Surprisingly, the dental cover part can maintain a vacuum for such a long duration even when the dental cover part is an inventory-universal cover (i.e., not a custom cover).
As described above, according to some embodiments, a dental treatment system may include a pumping member for pumping one or more treatment fluids. For example, the pumping member may be in fluid communication with the mouthpiece according to the teachings herein. Preferably, the pumping member is in fluid communication with the treatment delivery layer of the port member. The system may comprise a control unit for controlling the pumping means. The pumping means may be incorporated into the housing of the external control unit or the pumping means may be a separate element. The pumping means may incorporate a set of pistons that can compress a collapsible accordion-style disposable cartridge or other type of cartridge inserted into the control unit and deliver a controlled volume and flow of therapeutic material via the control unit tubing to a connected heating module unit for controlled heating and delivery of the therapeutic material via the mouthpiece coupler and the supply layer of the mouthpiece and to the mouthpiece treatment cavity. For example, a control unit including a microprocessor may monitor and/or control the temperature of the therapeutic fluid. The control of the temperature preferably employs a feedback loop. The temperature of the therapeutic fluid delivered to the oral components can be controlled using temperature control. The connected heating module unit may advantageously enable the practitioner to immediately utilize the whitening fluid (e.g. whitening gel) from storage, and thus eliminate the need for the following steps: the step is a step of thawing the whitening fluid, a step of warming the whitening fluid, a step of preparing the whitening fluid for dental treatment, or any combination thereof. As such, the dental treatment methods according to the teachings herein may be free of a combination or all of the above-described steps. By allowing the whitening fluid/gel to heat, the chemical activity and whitening capacity of the whitening fluid/gel may be significantly enhanced.
The inflow of the treatment material may allow the circulation of the treatment fluid/gel in the mouthpiece device of the present invention. The flow may be continuous or episodic (e.g., pulsed or intermittent). For example, when the whitening fluid flows in a turbulent manner within a sealed treatment cavity formed by the dental overlay, the amount of chemically active treatment fluid in contact with the enamel surface of the tooth is greatly increased as compared to if the treatment fluid were delivered into the oral component and statically held in place during the whitening treatment. This convective flow of therapeutic fluid around all enamel surfaces of the tooth increases the whitening potential of a fixed volume of therapeutic fluid delivered to the oral component. This is quite similar to the higher heat flux when heating food in a convection oven. For example, by flowing the treatment fluid contained in the mouthpiece device in a turbulent manner around the teeth (as hot air flows in a convection oven), the system significantly increases the volume of chemically active whitening fluid delivered to the mouthpiece, which can contact all of the enamel surfaces of the teeth. The increased volume of chemically active whitening fluid in contact with all of the enamel surfaces of the tooth results in a significant increase in the whitening effect of the fluid to all of these enamel surfaces of the tooth.
As noted above, the flow of therapeutic fluid may employ a pump assembly, such as a microprocessor-controlled pump assembly, in a sporadic or pulsed manner over a given time interval. This may allow for alternating static or convective flow of the treatment material (around the teeth) over a set period of time in the mouthpiece device.
The systems and methods may employ one or more pressure sensors for measuring pressure in the tube, for measuring pressure in the sealed cavity, for measuring pressure in a layer of the oral component (e.g., a treatment delivery layer and/or a dental cover layer), or any combination thereof. The pressure sensor may be incorporated into the control unit and/or into a heating module unit fluidly connected to the mouth piece. The pressure sensor may monitor, for example, a vacuum level in the mouthpiece, one or more flow rates, a total amount of therapeutic material delivered by the pump into the mouthpiece device or alternatively removed from the mouthpiece device, or any combination thereof. The sensor may also monitor the flow of therapeutic fluid during a "closed loop" treatment cycle. In some embodiments, magnets may be used to verify proper closure of the handle/coupling mechanism of the mouthpiece coupler (incorporated into the mouthpiece coupler) and the attached heating module unit and control unit tubing set. For example, the heating module unit may include an electromagnetic sensor to determine when the components (e.g., the heating module unit and the mouthpiece coupler component) are properly connected or not.
By maintaining a vacuum seal of the dental overlay of the dental mouthpiece with the gingival ridge, peroxidase enzymes naturally present in saliva are substantially or even completely prevented from penetrating into or otherwise penetrating the sealed cavity. The novel vacuum sealing feature of the present invention effectively protects chemically active therapeutic fluids such as whitening gels from chemical inactivation by salivary enzyme peroxidase. The whitening effect of the present invention is enhanced because the chemical oxidation potential of the therapeutic fluid is hardly impaired by saliva. Additionally, since saliva is always present in the mouth, the effective vacuum fluid seal of the mouth piece against the gingival ridge reduces or completely prevents saliva from entering the treatment cavity and diluting the concentration of the treatment material, thereby enhancing the efficacy of the undiluted treatment material as it is retained in the treatment cavity and in contact with the target tissue (hard tissue, or soft tissue, or both).
It will be further appreciated that the pumping member may allow the therapeutic fluid to continuously flow into and out of the flow outlet member throughout the treatment. As such, throughout the treatment, fresh new fluid with full chemical activity may be delivered and applied to some or all of the enamel surfaces of the teeth contained within the dental overlay. When used in whitening treatment, this can significantly improve the whitening results obtainable within the set time period of the present invention compared to static one-time delivery of the treatment material as is the case in known tooth whitening procedures.
According to some embodiments, flexible tubes may be connected to the pumping member from the fresh and used therapeutic fluid containers, and a separate set of flexible tubes connected to the pumping member are in turn connected to separate inflow and outflow tubes integral with the front of the mouth member. These inflow and outflow tubes may further be integrated in a fluid connection with a heating module unit, which in turn is fluidly connected to the integrated handle design (mouthpiece coupler) of the mouthpiece device.
A set of tubes from the pump assembly of the control unit to the mouthpiece device may be clamped via a fastening device or a small strap to some element or other fixed point of the patient's clothing, the patient's dental apron, or dental chair, so that any resistance caused by the set of tubes on the mouthpiece is reduced or eliminated, so that a tube or a set of tubes is neatly organized, or both a tube and a set of tubes are neatly organized.
The tube may comprise a multi-lumen segmented tube containing separate lines for inflow of the treatment material, a vacuum line for initiating and maintaining a vacuum in the mouthpiece and for sucking out used treatment material from the mouthpiece to a waste container in the control unit, separate conduits for flow of water from a water reservoir in the control unit or from a water line of the dental chair unit or other accessible water source, an air inlet line for flowing air into the mouthpiece, cables, sensors and illumination cables.
Another aspect of the present invention relates to a separate disposable elastic gum protector or barrier member that is needed in cases where the gums require additional protection from the treatment materials. The gum protector component can be used with dental treatment fluids and oral pieces of the present invention. The gum protector component can be used in the treatment of teeth with one or more fluids/gels for whitening teeth. The gum protector component can provide a sufficient barrier to the gums so that highly active therapeutic fluids can be used. The gum protector component may be designed to be inserted over the gingival ridges of the upper jaw, the lower jaw, or both. When using a treatment material that may damage the gingival tissue, the gingival protector member is preferably inserted into the oral cavity before inserting the mouthpiece into the oral cavity. For example, the gum protector/guard/barrier may be used to isolate the maxillary and mandibular gingival tissues covered by the mouth piece from even the highly concentrated hydrogen peroxide whitening gel or other potentially harmful therapeutic material that will be delivered into the treatment cavity well of the cover of the mouth piece device. The gum protector component can adequately cover and fluidly seal the gums while leaving the erupted teeth substantially exposed, so that peroxide at a concentration of about 15% or more, about 25% or more, about 35% or more, or about 45% or more can be used to whiten the teeth without damaging the gum tissue exposed within the treatment cavity of the mouthpiece.
The gum protector component can be provided as a kit comprising a plurality of gum protector components of different sizes. The gum protector component can be sufficiently flexible such that only a few different sizes of stock universal gum protector components are required to treat most patients. For example, the kit may include gingival protector components having about 2 or more different stock-common sizes, preferably about 3 or more different sizes, more preferably about 4 or more different sizes. The number of different stock universal sizes is preferably about 10 or less. The disposable gum protector may also have different sized or a variable number of teeth holes (e.g., a patient who has removed all four bicuspids as part of their orthodontic treatment).
In one of its embodiments, the separate and disposable gum protector barrier (i.e., gum protector component or gum protector component) may comprise a stretchable polymeric material. Preferred polymeric materials have an elongation at break of about 100% or greater, more preferably about 200% or greater, and most preferably about 300% or greater. Preferred polymeric materials have a sufficiently low tensile set such that the material recovers its original shape after being stretched. For example, the tensile set (the tensile set measured at
Each of the silicone and/or rubber bodies of the gum protector/guard may be pre-shaped to reflect the horseshoe arch shape and three-dimensional ridge shape of the gum ridge of each of the upper and lower jaws in order to fit very closely to these oral structures.
The body of the gum protector/guard component may be further modified to allow multiple perforation cuts (full cuts or perforations for selective removal) of different diameters and different spacings therebetween along the portion of the guard reflecting the center ridge line of the gum ridge and the position of the teeth of the upper and lower jaws. These incisions may be mirrored or coincide in their shape with the fan-like form/shape of the gum line (interdental papilla) of the teeth to be treated.
The body of the gum protector may incorporate within its interior a plurality of hollow tunnels on both its buccal and lingual/palatal sides simultaneously, which may be pre-filled with various light-curable polymeric resin materials.
The inner coating (facing the gingival ridge) of the gingival protector/guard component as described above may contain various chemical compounds, such as a sugar-based gel or a spray-on self-adhesive coating, the purpose of which is to provide chemical neutralization of the active therapeutic material, e.g. a peroxide-based whitening gel, and thus act as a chemical barrier to further protect the gingival tissue from the therapeutic material. As mentioned above, the gum protector/guard can provide an effective barrier to protect gum tissue from even very high concentrations of therapeutic materials, such as, for example, 35% or even higher hydrogen peroxide whitening gel.
The optional disposable gum protector/guard components described above can provide a flexible but snug barrier to the gums and alveolar gum ridge that can be placed over and through the eruption of the teeth and then seated on the gum ridge to be treated. When positioned in the arch in the mouth and fully seated on the gum ridge, the crown of the tooth may protrude out of the gum protector component while the gum protector component covers the gum. The assembled barrier (disposable gum protector/guard component) is further shaped to also allow for a good fit and seal of the deformable peripheral rolled boundary edge of either the single or dual arch mouth component devices, particularly when vacuum forces are applied to the mouth component, with both the upper and lower gum protector/guards. This allows for a good seal of the therapeutic fluid delivered into the mouthpiece device and prevents leakage of the therapeutic material from the mouthpiece device and prevents fluid of the mouthpiece device from adhering from the oral fluid seal to the underlying gum protector (which protects the gum/gum ridge).
The seal of the space around a row of teeth may be further enhanced by the unique deformable flap skirt design and the peripheral boundary rolled edge of the dental overlay of the mouth piece when the gum protector component is used with a dental treatment layer. This seal, in combination with the unique distal sealing plug, can enhance the ability of the pump to draw air out of the mouthpiece and form an effective vacuum fluid seal of the dental overlay against the outer sidewall surface of the previously installed gum protector component. It should be understood that upper and lower gum protector members may be employed to protect each of the gingival ridges of the upper and lower jaws.
This configuration and interrelationship of the components in the oral cavity can effectively and safely isolate the various concentrations of whitening agent applied to the teeth from the soft tissues (gums, tongue, cheeks, palate, oral mucosa) and can therefore protect these soft tissues from the caustic effects of even high concentrations of these chemical agents during the improved whitening treatment of the present invention.
Embodiments of the disposable gum protector/guard component allow the dentist to adjust the shape of the gum protector/guard component to further adapt the inner edges of the plurality of tooth cuts to the fan shaped gum line of any particular patient. A plurality of internal passages prefilled with various light curable resins or self-polymerizing resins and located on one of the buccal and/or lingual sides of the barrier may be incorporated into certain preferred embodiments of the gum protector barrier.
When inserted and seated onto the gingival ridge (by inserting a cut-out tooth hole through an anatomical crown portion of the tooth), the gum protector barrier can be tightly fitted to the patient's specific gingival ridge anatomy by pressing and molding the barrier to the underlying ridge on both its buccal and palatal/lingual sides and polymerizing and curing the light curable material contained within the channels of these respective faces of the barrier.
Additionally, the channel of the barrier pre-filled with the light curable resin material may extend into the natural anatomical undercut of the ridge (e.g., oral mucosa as an example) upon insertion onto the ridge. As the barrier is stretched and pressed into these natural undercuts of the gum ridge, the resin cures in situ to create an anchor for the new location of the barrier. Thus, the boundaries of the individual perforations can also be stretched by stretching the barrier into the undercut of the gum ridge (since the boundaries of the individual perforations are all part of the barrier structure), and each of the perforation boundaries can thus be adjusted to a new position determined by the operator and "frozen" by the operator to more closely fit the patient's particular gum line on a tooth-by-tooth basis. This is advantageous in whitening teeth because it allows the enamel surface of the tooth to be fully exposed to the gums while effectively protecting the gums of the gingival ridge contained within the mouthpiece and exposed to the high concentration of peroxide treatment gel.
As mentioned above, other embodiments of the disposable gingival protector may also include an inner coating that is a self-adhering coating when placed in contact with gingival tissue. These coatings can include various drugs or chemical compounds for therapeutic delivery of these various drugs or compounds to the gingival tissue. Further embodiments of the disposable gum protector/guard have a wider range of dental and medical applications, where a so-called "dry field" is necessary or advantageous for a given medical/dental procedure. The gum protector/guard may be used in many dental procedures as a substitute for what is commonly referred to in the dental field as a rubber dam. The gingival protector/guard may also be used to create an effective barrier to prevent saliva dilution or "rinsing" of drugs or other therapeutic materials placed on the gingival tissue or injected into gingival "pockets" (troughs) and then covered by a preformed three-dimensional gingival barrier.
The gum protector barrier may be made of a fluid-tight but gas-permeable elastic material to allow the gum protector barrier to be placed over the gum ridge for an extended period of time. This allows for prolonged exposure of the drug or therapeutic material on or in the gingival tissue without any dilution of the material or drug, while allowing the gingival tissue covered by the gingival covering to "breathe" throughout the time the barrier is applied and the barrier covers the gingival ridge.
Additionally, because the disposable gum protector/guard component is not integral with the appliance, the disposable gum protector/guard component can be provided in several stock sizes to match a mouth piece device of a given stock size, and thus provides effective isolation of the gums and other soft tissues of the mouth from even high concentrations of therapeutic material formulations without the need to manually apply a hardened foam material, as is common in current professionally applied intensive whitening procedures, without the need to customize the mouth piece or gum protector guard for each patient.
As described above, the disposable gum protector/guard can be a component that is itself an item of inventory manufactured in a variety of inventory sizes, or alternatively, the disposable gum protector/guard can be manufactured as a custom device for each patient using molding and die techniques known in the art. According to some embodiments, an optional tooth shade matching sensor unit may be incorporated into the control unit and may be used to record tooth shade values before and/or after treatment.
Another aspect of the present invention relates to a kit comprising a plurality of port members, such as a plurality of port members according to the teachings herein. The kit preferably includes stock-universal (i.e., non-custom) mouth pieces, and includes mouth pieces having different sizes. The kit may include mouth pieces having different widths for mating with mouths of dental arches having different widths (e.g., as measured between corresponding left and right molars). The kit may include oral components having dental arches of different lengths. It will be appreciated from the teachings herein that the use of a distal sealing plug may reduce or eliminate the need for port members having different lengths. By employing a kit of stock universal mouth pieces, the need for custom production of the mouth pieces (e.g., using dental mold impressions) can be eliminated. The kit may include a pre-assembled mouthpiece, or may include an inventory of universal dental overlays such as those according to the teachings herein. The kit may include a dental overlay adapted for use with the lower arch, the upper arch, or both the lower and upper arches. The kit preferably includes dental overlays of different widths for individuals having dental arches of different widths. The kit may include one or more treatment delivery layers, such as according to the teachings herein. The therapy delivery layer may be adapted to be connected to one or both dental overlays. By employing a distal sealing plug in the dental overlay that is adapted to seal against the back end of the dental arch, the need for dental overlays of varying lengths may be reduced or eliminated. Preferred kits comprise mouth pieces and/or dental overlays having two or more different stock-universal sizes, more preferably three or more different stock-universal sizes, most preferably four or more different stock-universal sizes. The number of different sizes may generally be large, but is preferably about 20 or more, more preferably about 10 or less, most preferably about 6 or less or even 4 or less.
In another embodiment, a method for performing a tooth whitening treatment is provided, wherein one or more of the following steps may be performed: a process configured for simultaneous customized tooth whitening; arranging the pump module to be connected to an oral part specifically designed for tooth whitening treatment; configuring a treatment setting on a control device coupled with the pump module; positioning a mouthpiece in a mouth of a patient; applying a flow control to create a vacuum between the mouth piece and the patient's gingival ridge anatomy; applying flow control to automatically manage delivery of material according to treatment settings; and removing the treatment material from the mouthpiece using flow control. Of course, other steps or combinations of steps may be used. For example, a baseline shade of the respective tooth may be measured prior to treatment to enable customized treatment of the respective tooth. In some cases, a gum protector may be used in addition to the mouthpiece and placed over the gingival ridge prior to insertion of the mouthpiece into the mouth, which may be a custom made or stock type guard. In other cases, the treatment material may be heated as needed during treatment.
Reference is now made to the various figures, which illustrate elements or aspects of various embodiments of the present invention. The drawings are provided for illustrative purposes only and are not meant to be limiting.
Figure 1a is a side view of one embodiment of the
According to further embodiments, the buccal
Fig. 1b is a front view of the
Fig. 2a is a top/front view of fig. 1a, in fig. 2a portion of the soft upper lacing notch l2a, the soft vacuum tube rear bore 16 is depicted for collecting treatment related fluids from the upper treatment lumen 23 and/or the lower treatment lumen 24 and connected to the soft vacuum tube 17 located in the
Fig. 2b is a top/back view of fig. 1a, in fig. 2b, depicting an embodiment of the buccal and palatal rolled
Fig. 3a is a top/back view of the
Fig. 3b is a bottom/rear view of the
Fig. 4a is a top close-up view of fig. 1a, in fig. 4a, depicting an embodiment of the buccal-side rolled
Fig. 4b is a rear view of the
FIG. 5a is a bottom view of one embodiment of the
Fig. 5b is an angled front view of the
Fig. 5c is a rear view of the
In some embodiments, the vacuum tube 3C may be designed with sufficient length to provide enhanced structure to prevent the vacuum tube from closing even if the patient bites or exerts substantial pressure on the soft mouth piece member of the mouthpiece when the
In some embodiments, the vacuum tube 3C may be designed to mechanically connect to the
Fig. 6a is a front view of one embodiment of the
Fig. 6b is a side view of the
Fig. 7 is an exploded view of an embodiment of the components of the
Fig. 8a is a side view of an embodiment of the
Fig. 8b is a side view of an embodiment of the
Figure 9 is a flow chart describing an example of a process for implementing gum treatment using a mouthpiece and associated components as described herein, according to some embodiments. As can be seen, according to some embodiments, provided herein is a method for performing a dental treatment, which may include one or more of the following steps: in step 900, a mouthpiece comprising one or more dental overlays is positioned over the upper and/or lower teeth; in step 905, applying a vacuum to the dental overlay such that a treatment cavity having a pressure below ambient pressure is formed around the upper and/or lower teeth and/or the surrounding gingiva, respectively, thereby creating a fluid seal of the overlay to the gingival ridge; in step 910, flowing one or more treatment materials into the sealed one or more treatment lumens; in step 915, the oral member and/or the anatomical structure of the treatment material is cleaned by flowing a cleaning material, such as water, optionally mixed with air at high velocity, into the oral member, and then flowing air alone to dry the teeth and/or surrounding gums; in step 920, considering whether to continue the treatment, if it is necessary to continue the treatment session ("yes"), then in step 925 the cycle is repeated, optionally with the same or new and/or alternative treatment material, by returning to step 910, optionally performing n times per pre-planned and/or dynamic treatment plan; if the therapy session does not need to be continued ("NO"), the therapy session is ended in step 930.
In some embodiments, after step 905, the system may verify the vacuum status and, if desired, may modify the vacuum pressure relative to the actual vacuum pressure and/or modify the treatment protocol as desired.
In some embodiments, the system may continuously verify the vacuum status throughout the treatment, and may modify the output of the vacuum pump to maintain the appropriate vacuum level throughout the treatment.
In some embodiments, if the vacuum level in the port cannot be maintained at a suitable level to ensure a fluid-tight seal of the port when material or cleaning fluid is flowed, the system will automatically stop flowing material into the port.
In some embodiments, step 905 is designed to maintain the integrity of the soft material of the oral component at or adjacent to the hardened stiffening elements to enable the treatment cavity, pocket, zone or region to remain intact in a selected location, e.g., around a selected tooth, gum, ridge, etc. In addition, step 905 is designed to selectively collapse the soft material of the oral component to enable the collapsing elements to provide a fluid seal at selected locations in the mouth, e.g., around selected teeth, gums, ridges, or selected portions of a gum ridge, etc. In this way, the treatment can be optimized by creating selected treatment areas in which the treatment material is optimally exposed and saliva is substantially prevented from entering to dilute or interfere with the treatment material. In addition, treatment can be optimized by creating safe zones that prevent exposure of the treatment material, thereby improving the safety of gums, teeth, etc. in these safe zones.
In some embodiments, in step 910, a new or alternative therapeutic material may be flowed into the flow member to provide an optimal amount of active therapeutic material.
In some embodiments, in step 915, the cleaning material may include a water-air mixture, or alternative material, liquid, gel, or the like, to enable removal of residual treatment material left on the oral component, existing gum guard, and/or target teeth or tissue, optionally using high velocity flow, high temperature, and/or other means, to mechanically and/or chemically remove unwanted residues of treatment material.
In some embodiments, in step 915, the flow of the cleaning material may be followed by flowing air into the flow component to enable drying of the oral component, existing gum guards, and/or target teeth or tissue to prepare the target surface for additional treatment cycles, for example, by removing any coatings that may interfere with exposure to the treatment material.
According to some embodiments, the running of one or more cycles may be a fully automated process defined by a preset treatment protocol. In other embodiments, the running of one or more cycles may be a semi-automated process defined by the treatment protocol. In other embodiments, the running of one or more cycles may be a manual process defined by the treatment protocol. In further embodiments, changes and modifications to the treatment cycle may be implemented during the cycle and/or treatment session. For example, if desired, the therapy session or cycle can be paused or stopped, in which case the system can shut down and/or recalibrate, reset, check, and continue the therapy session when instructed.
In some embodiments, after step 915 and/or step 930, the therapeutic waste material and/or the cleaning waste material may optionally be stored in a waste unit at the end of the treatment cycle and/or at the end of the treatment session and/or may be discharged directly out of the system.
Fig. 10 is a flow chart describing an example of a process for implementing a tooth whitening treatment using a mouthpiece and associated components as described herein, according to some embodiments. As can be seen, according to some embodiments, provided herein is a method for performing a dental treatment, which may include one or more of the following steps: in step 1000, a gum protector is positioned over and through a selected tooth to expose an eruption of the tooth while leaving the surrounding gums protected; in step 1005, positioning a mouthpiece comprising one or more dental overlays on the upper and/or lower teeth; in step 1010, applying a vacuum to the dental overlay such that a treatment cavity at a pressure below ambient pressure is formed around the teeth and/or around the surrounding gums, thereby creating a fluid seal; in step 1015, flowing one or more therapeutic materials into the sealed treatment cavity; in step 1020, the oral member and/or the anatomical structure of the treatment material is cleaned by flowing a cleaning material, such as water and/or water mixed with air, and then flowing air alone, optionally at high speed, into the oral member; in step 1025, considering whether or not to continue the treatment, if it is desired to continue the treatment session ("yes"), then in step 1030 the cycle is optionally repeated using the same or new and/or alternative treatment material by returning to step 1015, optionally performing n times per pre-planned and/or dynamic treatment plan; if the therapy session does not need to be continued ("NO"), the therapy session is ended in step 1035.
Fig. 11a is a front view of an
Fig. 11b is a top view of the
Fig. 11c is a top view of an inner frame reinforcement element according to some embodiments. It can be seen that the reinforcing
In some embodiments, a pressure sensor may be incorporated into the pump mechanism to monitor the internal pressure inside the mouthpiece device throughout the treatment. In one example, increased pressure inside the mouthpiece represents a decrease in vacuum seal integrity and increases the potential risk that therapeutic material will leak out of the mouthpiece and into the patient's mouth or alternatively cause saliva to enter the mouthpiece. Both possibilities are undesirable.
Chemically active therapeutic materials such as whitening agents may release, for example, oxygen during their oxidation/whitening reactions. The release of free oxygen from the gel may increase the internal pressure inside the mouthpiece device. In some embodiments, if the internal pressure (monitored by the pressure sensor and microprocessor) reaches a critically high value, the patient may be instructed to bite harder into the mouthpiece and the system will automatically begin to evacuate the treatment material contained within the mouthpiece and then pump into water to rinse the teeth or alternatively pump into new treatment material. Alternatively, removing the over-activated treatment material present in the mouthpiece with fresh treatment material may help reduce the internal pressure inside the mouthpiece and thus allow treatment to continue without rinsing the teeth.
The above-described features of the system allow for easy and quick removal of treatment material from the mouthpiece device such that there is little spent treatment material remaining on both the mouthpiece device itself and the enamel surface of the treated tooth when the mouthpiece device is removed from the patient. This simplifies the task of the operator to remove any partially or fully depleted therapeutic material from the patient's mouth. In some embodiments, the controlled removal of used treatment material may be performed automatically by the control unit at the end of a set period of time, or manually initiated by the operator pressing a button that activates the removal/aspiration of material at any time during treatment.
More importantly, applying material in the form of waves or pulses interrupted by wash/dry cycles between each application of material allows the previously applied waves or pulses of material to be substantially removed and replaced with new fresh material. With this application and removal method, the entire available volume of each treatment material can be maximized in surface contact with the surface of the teeth and/or surrounding gums and exposed to the surface of the teeth and/or surrounding gums.
In some embodiments, several applications of fresh treatment material (several applications of a volume of gel required to fill the mouthpiece) may be so applied and removed until the operator and patient are satisfied with the whitening or other treatment results. Of course, any combination of the above steps may be implemented. In addition, other steps or series of steps may be used.
In various embodiments of the present invention, the above-described design elements allow for rapid, intense, and controlled simultaneous whitening of the arch or arches of the anterior and posterior teeth, as well as whitening of the external (buccal), internal (lingual) and occlusal (top/occlusal) surfaces of both the anterior and posterior teeth. These embodiments further enable effective protection of the patient's soft tissue from the caustic effects of various concentrations of whitening agent applied to the teeth, while optionally maintaining and monitoring the patient's safety, progress, and/or comfort in real time throughout the treatment.
It will be appreciated that for simplicity and clarity of illustration, elements illustrated in the figures have not necessarily been drawn to scale. For example, the dimensions of some of the elements may be exaggerated relative to other elements for clarity. Further, where considered appropriate, reference numerals have been repeated among the figures to indicate corresponding or analogous elements throughout the series of views.
The principles and operation of an apparatus and method according to the present invention may be better understood with reference to the drawings and the following description, it being understood that these drawings are given for illustrative purposes only and are not meant to limit the invention.
The foregoing description of various embodiments of the invention has been presented for the purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed. Those skilled in the art should appreciate that many modifications, variations, substitutions, changes, and equivalents are possible in light of the above teachings. It is, therefore, to be understood that the appended claims are not intended to cover all such modifications and changes as fall within the true spirit of the invention.
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