HK1198902B - Devices, systems and methods for the whitening of teeth - Google Patents

Description

Devices, systems and methods for teeth whitening

Declaration of priority

This application claims priority to U.S. Provisional Patent Application No. 61/533,303, filed on September 12, 2011, entitled “Devices, Methods and Systems for the Whitening of Teeth,” and U.S. Provisional Patent Application No. 61/596,238, filed on February 8, 2012, by the same inventors, entitled “Devices, Methods and systems for the Whitening of Teeth,” the entire contents of which are incorporated herein by reference.

Technical Field

The devices and methods of the present invention relate to dental treatments, and more particularly, to tooth whitening treatments.

Background Art

There are large differences in the visual color values of teeth. It is also commonly found that due to various natural factors, there are large differences in different teeth in the mouth of the same person. Typically, in the same person, for example, the upper and lower canine teeth are more "yellow" in color than the upper central incisor, lower central incisor and lateral incisor, and it is commonly found that the upper (maxillary) teeth are generally "whiter" than the lower (mandibular) teeth. It is also commonly found that the front teeth are generally "whiter" than the back teeth. The known dental whitening treatments to be described below do not take into account any of these significant differences in the baseline (pre-treatment) color that is typically present in the same patient before treatment. This means that, regardless of the whitening effect obtained, the whitening technology currently in use cannot generally be customized to a given patient's needs based on the initial different baseline color values of the teeth presented by the patient before treatment. Therefore, it is extremely unlikely to obtain a completely consistent final whitening result using the current systems in use.

There are a variety of over-the-counter consumer "whitening" products, such as toothpaste, whitening strips, and mouthwashes. These will not be discussed further.

Standard professional dental treatments for whitening teeth involve providing the user with some form of tray appliance (custom-made from a mold of the teeth obtained from each patient) by way of a dental office, and with a smaller concentration of whitening agent for self-application at home. These treatments are generally referred to as "at-home" whitening methods.

The anatomical area behind the terminal teeth on the left and right sides of the maxillary and mandibular teeth is called the retromolar pad. Dental tray appliances are typically manufactured to cover these terminal teeth, and their terminal boundaries are the retromolar pads. There is significant variability among patients in the size of their teeth and the shape of their dental arches. The variable width and length of the dental arches must be taken into account when manufacturing a dental tray to properly cover all the teeth contained within any given dental arch.

The user is instructed to fill the entire dental arch tray with a mild whitening agent (gel) and place the tray on the teeth for up to several hours each day over a minimum of one to two weeks. The custom trays cover all teeth in the upper or lower jaw. This means that the user can whiten their front teeth and molars with this treatment method using one tray for the upper teeth and one tray for the lower teeth. This teeth whitening technology is called a "compression" technology because the whitening agent is primarily contained within the enclosed confines of the trays and is not exposed to the atmosphere during the treatment.

It has been shown that the use of compression technology with whitening agents can enhance whitening because it encourages the oxygen ions released by the whitening agent (the primary means of whitening teeth) to move towards the interior of the tooth's enamel structure rather than being released into the surrounding air (Miara and Miara, 2003).

It has been shown that natural saliva in the mouth contains peroxidase, which naturally decomposes and neutralizes hydrogen peroxide (Tenovuo and Pruitt, 1984). Using custom professional whitening trays that fit the teeth more closely than over-the-counter whitening trays reduces the amount of saliva that can penetrate the tray and come into contact with the active hydrogen peroxide that has been placed in the tray. This reduces the amount of saliva that is inactivated or decomposed by the active gel and thereby increases the chemical whitening effect of professional whitening treatments compared to over-the-counter whitening trays (which do not fit the teeth well and allow a larger amount of saliva to leak into these trays).

The custom "whitening" tray appliances of the "at home" treatment methods mentioned above require two dental visits. During the first office visit, a dental impression of the dental arch is taken in the dental office, from which custom-fit rigid or semi-rigid thin plastic "whitening" trays are manufactured. The contours of the outer limiting surfaces of these trays can closely match the teeth or be made significantly larger than the teeth. The above "at home" treatment methods require the user to invest a lot of time (as mentioned above) to achieve a moderate degree of teeth whitening, and often result in tooth sensitivity due to excessive exposure of the teeth and gums to the whitening agent, as well as irritation or chemical burns to the gums and oral mucosal tissues of the mouth. Many patients find that the effort required to achieve a sufficiently "whiter teeth" result is too heavy and often fails to meet the requirements at a very high rate, resulting in a poor final teeth whitening result.

These apparent deficiencies in professional "at-home" whitening treatments have given rise in recent years to professional dental treatments known in the dental art as "in-office" treatments or "power whitening" treatments. This treatment involves application in a dental office, using and under the supervision of professional dental staff, and using various tooth whitening chemicals in higher concentrations (and more corrosive) than previously used in "at-home" whitening treatments. This "power" tooth whitening technique typically requires a treatment time of around an hour. To protect the gum tissue from these high concentrations of whitening agents, a "paint-on dam" or protective coating (a layer of material applied in strips at the gum line, arranged in a fan-shaped shape so as to contour to the gum line) is applied by hand (very time-consuming) and hardened by standard dental UV light. Additionally, uncomfortable lip and cheek retractor devices are inserted into the mouth along with cotton rolls (and gauze if needed) to try and protect the rest of the oral tissue of the mouth from these highly concentrated and aggressive whitening agents.

These precautions are necessary because contact of these high concentrations of chemical whitening agents used in "power" whitening with the above-mentioned soft tissues of the mouth will cause significant chemical burns and pain to the patient within seconds. Typically, three applications of the whitening agent limited to the buccal (front) surface of the front teeth are performed (each lasting about 20 minutes), wherein the previous application is cleaned and aspirated from the teeth and replaced by the next application. The entirety of the paralingual (inner) surfaces of the front and back teeth cannot be "whitened" using this technology. The "power" whitening technology does not utilize any kind of tray device. The whitening agent is applied to the outer buccal surfaces of the limited teeth to be treated in an open, "non-compressed" coating manner, and therefore does not have the whitening advantages of utilizing the compression effect of the whitening gel of the tray as previously described (home whitening technology).

Over the past two decades, there has also been a shift in "in-office" treatments or "power whitening" treatments to utilize "light-activated" whitening agents, as opposed to older whitening agents that did not require light activation to enhance the oxidation (whitening) chemical reaction. These newer light-activated whitening agents are chemically formulated to oxidize when exposed to a concentrated, intense light source, which acts as a catalyst to enhance the chemical oxidation of these whitening agents.

There has been much debate in the dental field as to whether the use of light activation of whitening gels enhances the chemical whitening effect of these gels. It has been hypothesized that it is actually the heat generated by the light, rather than any specific wavelength of light, that actually increases the chemical activity and, therefore, the whitening activity of these whitening gels.

Light-emitting devices currently in use in dentistry generally only reach the front of the mouth, and only after the lips and cheeks have been retracted using the devices 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 a light source and high concentrations of "powerful" whitening agents, while still protecting the soft tissues of the mouth from these highly aggressive whitening agents.

As mentioned above, these limitations typically result in a "power whitening" treatment of a maximum of the top 10 teeth and the bottom 10 teeth (upper and lower central and lateral incisors, canines, and first and second bicuspids), resulting in a maximum of 20 teeth being treated (of which there are typically 28-32 teeth in a human mouth). Due to the limitations already mentioned, it is common practice to find that only the top 8 and bottom 8 front teeth are "power" whitened, resulting in a total of 16 teeth (only 50%) in the patient's mouth being "power" whitened, which is a significant shortcoming of this tooth whitening technology.

Another limitation of the treatment area is that the lamp used for typical "powerful" whitening can be positioned by the operator into the patient's mouth to illuminate primarily the buccal (front or outer) surfaces of the front teeth, while only weakly illuminating the lingual (back or inner) surfaces of these front teeth. It is also very difficult for dentists to apply a "smear barrier" protective coating at the gum line on the lingual "inner" surfaces of the front teeth, and it is almost impossible for dentists to isolate the very active tongue using the current isolation devices and materials available in the dental field. This means that these sensitive oral tissues are extremely difficult to isolate from the aggressive chemical burns of high concentrations of "powerful" whitening agents.

The above explains why whitening of the inner (paralingual) surfaces of the front teeth is rarely performed with this technology, and why back teeth cannot be whitened at all using this technology. Furthermore, "powerful" whitening of only the buccal (outer) surfaces of the front teeth adversely affects the overall final whitening effect because the natural enamel layer of the teeth (naturally found on the outer and inner surfaces of all teeth) is naturally somewhat translucent. This allows the "darker" tone of the inner (paralingual) untreated surfaces of the teeth to "show through" to the front surfaces. This naturally occurring light effect can "dial" or reduce the overall final whitening effect of these teeth when using current "powerful" whitening treatment methods.

Advantages of an "in-office" or "power" whitening treatment over an "at-home" treatment include: a. it allows for more rapid whitening of the teeth compared to an "at-home" treatment due to the use of a higher concentration of whitening agent. This significantly reduces the overall treatment time; b. when performed "in-office," patients have fewer non-compliance issues that are often encountered with lengthy "at-home" treatments; and c. while some users do experience tooth sensitivity (due to the higher concentration of chemical oxidizing agents used in such treatments, and the often-encountered small amounts of unwanted leakage of high-concentration whitening agents across the protective barrier placed on the oral tissue by the dentist during "power" whitening treatments), the shorter treatment time tends to minimize irritation or sensitivity to the teeth because the teeth are exposed to these preparations for a shorter period of time.

The disadvantages of the "in-office" treatment method compared to the "at-home" treatment include: a. As noted above, only the front teeth can be comfortably whitened with the "in-office" method, compared to the "at-home" treatment (which allows the whitening of the front teeth and molars); b. As mentioned above, the higher concentration formulations of whitening oxidants are more aggressive to the hard (teeth) and soft (gingiva, oral mucosa, tongue) tissues of the mouth, and thus require the application of special hand-applied gingival and oral mucosal barriers to the gingiva and oral mucosal tissues of the area to be treated by professional dental staff under the supervision of the dentist, or by the dentist himself, to protect them from these high concentrations of whitening chemicals. This is a very time-consuming process that often requires repeated applications during treatment to properly protect the soft tissues of the mouth from these high concentrations of whitening agents. Even with all of this isolation effort, as described above, it is often found that some leakage and burning of the patient's oral tissues results in temporary pain and discomfort for the patient; c. due to the inaccessibility of the back teeth and the difficulty of accessing the back area of the mouth (due to the cheeks and tongue), these whitening treatments are always restricted or limited to the front section of the mouth (due to the extreme difficulty of protecting the oral soft tissue surrounding the back teeth); d. they primarily whiten the front (buccal) surfaces of the front teeth, and only rarely are they used to whiten the inner (paralingual) surfaces of the front teeth; and e. a more pronounced "rebound" effect (loss of whitening effect) is often observed after treatment with this "in-office" treatment method compared to "at-home" treatment methods. This is due to the short treatment time (compared to the longer treatment time of "at-home" treatment methods) and the rehydration of the teeth that occurs after treatment ("power" whitening processes tend to temporarily dehydrate the teeth, which temporarily enhances the initial whitening effect). This means that the typical final "whitening" result using "power" whitening techniques is significantly less than the final "whitening" result achieved when the patient is highly compliant and uses "at-home" whitening techniques appropriately.

Summary of the Invention

According to embodiments of the present invention, a device, method, and system for assisting in tooth whitening are provided. The device includes a mouthpiece suitable for performing dental treatment, wherein the mouthpiece includes: one or more existing tooth covering layers suitable for forming a treatment cavity with a vacuum, wherein the tooth covering layers include a layer positioned over the upper teeth and/or a layer positioned over the lower teeth; and one or more treatment supply layers, wherein the treatment supply layer has one or more flow channels, wherein the one or more flow channels are in fluid communication with the treatment cavity, thereby enabling the treatment supply layer to deliver one or more treatment fluids to the treatment cavity and/or remove the one or more treatment fluids from the treatment cavity.

In some embodiments, the tooth covering vacuum is formed using a continuous or selectable continuous sealing mechanism comprising a sealing rim formed of a compressible material in combination with one or more sealing plugs attachable to the posterior opening of the tooth covering, wherein the continuous sealing mechanism adequately seals the treatment cavity.

In some embodiments, the sealing mechanism is adapted to prevent saliva from entering the treatment cavity and to prevent treatment material from leaving the treatment cavity.

In some embodiments, the treatment supply layer includes one or more heaters for heating the treatment material, for heating at least a portion of the treatment cavity, or both.

In some embodiments, the device includes a handle integrally formed in the treatment supply layer, the handle being adapted for: inserting the one or more dental coverings onto the upper and/or lower teeth, for adjusting the position of the one or more dental coverings, for removing the dental coverings after the dental treatment is completed, or any combination thereof.

In some embodiments, the device includes: a power cord for delivering current to the treatment supply layer; and one or more tubes for delivering one or more treatment materials to the treatment supply layer and/or extracting one or more treatment materials, and the handle includes the power cord or includes both the one or more tubes and the power cord.

In some embodiments, the dental covering covers the gingival ridge.

In some embodiments, the device includes: two tooth covering layers for covering the upper teeth and the lower teeth; at least one treatment supply layer between the two tooth covering layers so that the upper teeth and the lower teeth can be treated simultaneously; wherein the device includes one or more breathing vents located in the treatment supply layer, the breathing vents being suitable for providing air passages in and out of the mouth during dental treatment.

In some embodiments, the handle comprises: one or more inflow conduits for flowing one or more therapeutic materials into the therapeutic supply layer; and one or more outflow conduits for flowing one or more therapeutic materials out of the therapeutic supply layer.

In some embodiments, the dental pad includes: one or more delivery holes for allowing the treatment material to flow from the treatment supply layer to the treatment cavity; and one or more discharge holes for allowing the treatment material to flow from the treatment cavity to the treatment supply layer; and wherein the treatment supply layer includes: one or more delivery channels for transporting the treatment material from the inflow pipe to the treatment cavity; and one or more discharge channels for transporting the treatment material from the one or more discharge holes to the outflow pipe.

In some embodiments, the dental covering includes a compressible cavity plug adapted to seal the cavity to prevent material from flowing out of the back side of the vacuum-forming layer.

In some embodiments, the device includes one or any combination of the following design features: a dental cover layer incorporating a curved cut-out skirt design for conforming to the gingival ridge; a treatment supply layer including one or more individually controllable heating zones; a dental treatment layer positioned between the upper and lower dental cover layers, and the dental treatment layer is shaped to mirror the hinge axis angle to facilitate natural jaw movement.

In some embodiments, the vacuum is created via the treatment supply layer by reducing the pressure in the dental treatment cavity to below ambient pressure.

In some embodiments, the device may include: a pumping system for pumping one or more treatment materials into the dental pad; a multi-position flow control module; and a control unit for automating dental treatment.

In some embodiments, the device includes a dental gum guard for providing additional protection from erosion by the treatment material.

In some embodiments, a device comprises a dental gum guard comprising a gum treatment layer on an inner surface thereof for delivering one or more treatment materials to the gums.

According to some embodiments, a dental gum guard is provided that may include a flexible surgical arch drape designed to substantially conform to the anatomy of the gum ridge and having pre-configured cutout holes for custom insertion onto teeth for providing a dry field.

In some embodiments, a dental gum guard comprises a layer of therapeutic material on one or more surfaces, wherein the therapeutic material is adapted to neutralize the therapeutic material.

In a further embodiment, a method for performing a dental treatment is provided, comprising: positioning a dental block on upper and/or lower teeth, the dental block comprising one or more dental coverings; applying a vacuum to the dental coverings to form a sealed treatment cavity around the teeth, the sealed treatment cavity having a pressure lower than ambient pressure; and flowing one or more treatment materials into the sealed treatment cavity.

In some embodiments, the method includes one or any combination of the following steps: configuring a pump module to connect to a dental pad designed for teeth whitening treatment; configuring treatment settings on a control device coupled to the pump module; applying a flow control module to create a vacuum between the dental pad and the patient's gingival ridge structure; and applying the flow control module to automatically manage the delivery of material according to the treatment settings, and/or using the flow control module to remove treatment material from the dental pad.

In some embodiments, the method includes the step of applying flow control to alter the flow pattern during treatment to optimize compliance with the treatment plan.

In some embodiments, the method includes the step of monitoring treatment to track compliance with the treatment plan.

In some embodiments, the method comprises the step of monitoring the treatment to identify problems during treatment.

In some embodiments, the therapeutic supply layer comprises a plurality of regions including a first region and a second region, wherein the method comprises providing different therapeutic materials to the first region and the second region.

In some embodiments, the therapeutic material differs in the temperature of the material, the concentration of the material, or both.

According to some embodiments, the treatment device can be an off-the-shelf product that can be provided in multiple off-the-shelf sizes and that can be reusable or can be a disposable item that can include a single arch dental pad or a double arch dental pad that has a breathing tube integrated into the body of the device that allows the patient to breathe through the mouth when the double arch dental pad is inserted into the oral cavity. The dental pad device has flexible side walls that have a uniquely designed deformable circular circumferential skirt that adapts to the upper and lower alveolar ridges of the mouth. The well formed by each arch contains a rear sealing plug at its distal end (left and right). The plug is formed of a highly deformable material that, when bitten into, conforms tightly to the anatomy of the crown of the tooth biting into it. The plug, in conjunction with the uniquely designed deformable circumferential skirt of the rim well, allows the bite block device to closely conform to the upper and lower alveolar ridges and the most distal teeth (left and right teeth), thereby forming a tight, continuous or selectively sustainable seal of the bite block relative to these structures.

The dental pad device also includes multiple flow channels with outlets and inlets in its middle layer and multiple heating elements arranged in various arrays along its various surfaces, the temperatures of which can be individually controlled by a microprocessor unit contained in the control unit. In some embodiments, these heating elements can be printed circuit resistors. Metal pins can be connected to these pins, and the pin heads can be in contact with the treatment cavity, thereby effectively transferring the heat generated by the resistors to the treatment cavity and the treatment material contained in the treatment cavity. The microprocessor unit can control the electrical power, duration, alarms, sensors, individual or multiple heating elements, pumps, motors, and other controllers. Before inserting the dental pad, a variety of different types and sizes of customizable or off-the-shelf disposable separate gum protection/guard elements can be inserted into the mouth and used in conjunction with the device.

A pump assembly can be used to create a vacuum within the dental pad device. Different concentrations of chemical whitening agents can be preheated to a specific controlled temperature in a disposable heating chamber and then delivered in a controlled manner via the disposable pump and a set of disposable flexible tubing connected to the dental pad device. A pressure sensor is integrally formed in the system to monitor the volume and flow rate of the gel and the vacuum seal integrity of the dental pad in the mouth. The whitening gel can similarly be removed from the device in a controlled manner by the system. Similarly, fresh water can be delivered to and removed from the dental pad device to rinse or wash away any remaining gel from the inner surface of the dental pad and from the teeth.

To achieve the above objectives, a motor contained in the pump and controlled by the microprocessor of the control unit drives a multi-position flow control valve to allow: 1. a continuous or selectively continuous vacuum to be formed in the dental pad; 2. the delivery of whitening gel to and removal from the dental pad; 3. a unique "closed loop" steady or pulsed dynamic flow of gel within the dental pad; 4. the delivery of water to and removal from the dental pad to rinse or wash away any residual gel from the tooth surface and the inner surface of the dental pad.

An optional tooth shade matching sensor for recording pre- and post-treatment tooth shade values can be incorporated into the control unit. Additionally, a removable belt with sensors connected to the control unit and measuring certain vital signs of the patient (e.g., pulse rate) can be attached to the patient to monitor the patient's comfort level throughout treatment.

According to different aspects of the present invention, such a device for providing dental treatment may include: a deformable gum sealing portion for covering the gums; a distal tooth sealing portion, wherein the gum sealing portion and the distal tooth sealing portion define a gap between at least a portion of the device and the tooth on which the portion is located; and at least one fluid conduit portion for allowing fluid to flow into or out of a treatment cavity; wherein, when the gum sealing portion is placed on multiple teeth in a patient's mouth, the gum sealing portion contacts the patient's gums and deforms against the patient's gums to form a close contact with the gums, and the distal tooth sealing portion deforms against the distal teeth and is distally positioned to define a seal substantially at the distal teeth, so that fluid can be introduced into the treatment cavity, removed from the treatment cavity, or both, while maintaining the seal by the deformable gum sealing portion and the tooth sealing portion.

BRIEF DESCRIPTION OF THE DRAWINGS

The principles and operations of the systems, devices, and methods according to the present invention may be better understood with reference to the accompanying drawings and the following description. It will be understood that these drawings are provided for illustration purposes only and are not intended to be limiting.

FIG1A is a top view of an example of a dental block device 1 according to some embodiments, showing a dental arch vacuum-formed layer formed of a flexible material having a compressible rim designed to form a treatment cavity between an upper or lower tooth and the gingival ridge;

FIG1B is a bottom view of an example of a bite block device 1 according to some embodiments;

FIG1C is an additional view of an example of a bite block device 1 according to some embodiments;

FIG2A is a front view of an example of a bite block device 1 according to some embodiments;

FIG2B is a side view of an example of a dental pad 1 according to some embodiments;

FIG2C is a top view of an example of an intermediate layer according to some embodiments;

FIG2D is a bottom view of an example of an intermediate layer 4 according to some embodiments;

3 is an enlarged top view of an example of a front section of an intermediate layer according to some embodiments;

4A is a front (labial) view of an example of an intermediate layer according to some embodiments;

FIG4B is a medial (lingual) view of FIG4A , according to some embodiments;

FIG4C is a front (labial) view of an example of a device plate and layers according to some embodiments;

5A is an exploded front (buccal) view of a vertical stack of one possible embodiment of components comprising a dual-arch bite pad, according to some embodiments;

5B is an exploded posterior (lingual) view of the vertical stack of FIG. 5A , illustrating components including a dual-arch bite block according to some embodiments;

FIG6A is an internal (lingual) view of an example of a bite block device according to some embodiments;

6B illustrates the view of FIG. 6A , wherein a vertical cutaway of a distal cross-section of the bite block device has been made, according to some embodiments;

FIG6C shows FIG6B with upper and lower distal plugs 7 and 8 removed, according to some embodiments;

FIG6D is a medial (lingual) view of an intermediate layer according to some embodiments;

FIG6E is an angled front view of a bite block assembly according to some embodiments;

FIG7 is an enlarged internal (lingual) view of an example of a dental pad 1 according to some embodiments;

FIG8A is a front (labial) view of a dental pad according to some embodiments;

FIG8B is an enlarged view of the inner side (the surface facing the dental pad 1 ) according to some embodiments;

FIG8C is an enlarged view of the outer side (the surface facing away from the bite block 1 not shown) of the quick attach connector according to some embodiments;

9A is an angled view of a side of an example of a pump mechanism assembly, according to some embodiments;

FIG9B is an angled view from the opposite side of FIG9a according to some embodiments;

FIG9C is a top view of a pump mechanism assembly according to some embodiments;

9D is a front view of a pump assembly according to some embodiments;

FIG10 is a top/front view of one possible implementation of a control unit according to some embodiments;

FIG11 is a top/rear view of the control box 50 and the battery pack charging unit 52 according to some embodiments;

FIG12A is an exterior surface (bottom) view of one possible implementation of an upper gum guard according to some embodiments;

FIG12B is an interior surface (top) view of FIG12a, according to some embodiments;

FIG12C is an exterior surface (top) view of one possible implementation of a lower gum guard according to some embodiments;

FIG12D is an interior (bottom) view of FIG12c, according to some embodiments;

FIG. 13A is a front view of a vertical stack of upper and lower gum guards 59, 60, according to some embodiments;

FIG13B is a front view of the upper jaw according to some embodiments;

FIG. 13C is a front view of an example of a bite block device 1 inserted between the upper jaw 24 and the lower jaw 25, respectively, according to some embodiments; and

14 is a flow chart illustrating an example of performing a teeth whitening treatment using the dental pad and associated components described herein, according to some embodiments.

It will be understood that, for simplicity and clarity of illustration, the elements shown in the drawings are not necessarily drawn to scale. For example, the dimensions of some elements may be exaggerated relative to other elements for clarity. Furthermore, while certain numbers of elements have been shown according to particular embodiments, other embodiments may be provided with fewer or more elements, such as holes, pins, heating elements, conduits, etc. Furthermore, where deemed appropriate, reference numerals may be repeated among the drawings to indicate corresponding or similar elements in that series of views.

Detailed description of the invention

The following description is provided to enable one of ordinary skill in the art to make and use the present invention as provided in the context of a specific application and its requirements. Various modifications to the described embodiments will be apparent to those skilled in the art, and the general principles defined herein may be applied to other embodiments. Therefore, the present invention is not intended to be limited to the specific embodiments shown and described, but rather should be given the widest scope consistent with the principles and novel features disclosed herein. In other cases, well-known methods, processes, and components have not been described in detail so as not to obscure the present invention.

Preferred dental treatments utilize one or more chemical materials, such as peroxides, that whiten teeth through one or more chemical reactions. Embodiments of the present invention enable increased efficiency and effectiveness of dental treatments by using a vacuum to create a sealed treatment cavity or area, allowing optimal application of treatment materials within the cavity or area while also preventing them from escaping outside the sealed treatment cavity. Non-limiting embodiments of the present invention include dental treatment devices, methods, and systems, such as for tooth whitening.

Embodiments of the present invention incorporate features that take into account one or any combination of the advantages and disadvantages of the two treatment methods listed above (such as intensive whitening in the office and custom-made tray whitening at home) and materials currently used in the dental field. Embodiments of the present invention include a dental treatment tooth pad that may include a single dental arch or a double dental arch. The tooth pad can be used to provide whitening treatment. The tooth pad may include one or more dental covering layers for covering the upper teeth and/or the lower teeth. The dental covering layer is preferably an arch (such as a dental arch) that is configured to fit over either the lower teeth or the upper teeth. For example, the tooth pad may include an upper dental covering layer and a lower dental covering layer (for example, the tooth pad may include a double dental arch). The dental covering layer may have a dental arch well that covers the teeth. A particularly preferred dental pad includes two dental covering layers, each having a dental arch well, wherein the two dental covering layers are joined together to form a single device. It should be understood that according to the teachings herein, the two jointly joined dental covering layers may be joined via one or more additional layers (such as one or more treatment supply layers).

Bite pads according to some embodiments of the present invention allow for the use of generic or off-the-shelf bite pads in a patient, thereby enabling the processing of a patient's entire dental arches having varying widths and lengths without the need for a custom bite pad to be manufactured for each patient. When such an off-the-shelf bite pad is used, embodiments of the present invention enable a continuously sealed bite pad to be maintained for a given dental arch upon which the bite pad is placed. The distal plug is highly deformable such that when the patient is instructed to bite down onto the bite pad, the plug will readily deform around the coronal portion of the terminal tooth. This close fit of the improved bite pad of the present invention to any given dental arch is independent of the length and width of the dental arch with which the bite pad is to be fitted, and is independent of the position of the right or left terminal teeth of any given dental arch relative to their respective retromolar pads.

The device, the dental treatment pad (e.g., a whitening pad), or both can be reusable or disposable after a single use. The pads can be constructed in a variety of common or off-the-shelf sizes (e.g., small, medium, large, extra-large) for both upper and lower teeth or can be customized. The pad can include one or more heating elements for heating a dental treatment fluid (e.g., a dental treatment fluid suitable for chemically whitening teeth), for heating an area of the tooth covering, or for both. For example, the dental treatment pad can have multiple areas, each heated by a different heating element. Each area can be heated to the same temperature so that the teeth receive the same dental treatment. In different aspects of the invention, two or more areas can be heated to different predetermined temperatures so that the teeth receive different treatments. The use of different predetermined temperatures can advantageously result in teeth having a more consistent color (e.g., between different teeth or between different areas of the same tooth).

The device can be used in a system comprising one or more control units (such as a control unit comprising a microprocessor). The control unit can be an external control unit. The control unit can control the temperature of one or more heating elements (e.g., so that multiple zones have predetermined temperatures, which can be the same or different). The control unit can control a dental pad having two dental arches, each of which has an arch well, thereby controlling the simultaneous whitening of both upper and lower teeth.

The dental arches of a dental block (e.g., each arch of a cohesive dual-arch dental block) preferably have dental coverings with arch-shaped wells or other designs suitable for forming treatment cavities (which can contain one or more dental treatment fluids). For example, the arch-shaped wells can contain a dental fluid containing an active ingredient at a predetermined concentration. The active ingredient can be any chemical material suitable for in situ tooth whitening. Particularly preferred active ingredients include one or more peroxides. The two dental coverings of a dual-arch dental block can have wells containing the same or different concentrations of the active ingredient. A single well can have multiple regions or zones with different concentrations of the active ingredient. It will be appreciated that dental blocks according to the teachings herein can be used to provide greater differences in the concentration of the whitening agent. The difference in the concentration of the active ingredient (e.g., the whitening agent, which can be a peroxide such as hydrogen peroxide) between the two dental coverings and/or between the two zones or zones can be about 0% or greater, about 5% or greater, about 15% or greater, or about 25% or greater. It will be understood that even greater concentration variations can be employed in accordance with the teachings herein. For example, the difference in concentration of the active ingredient can be about 35% or greater. The active ingredient can be activated or reactive, and the reactivity is accelerated or enhanced in other ways by heat (e.g., catalyzed, or otherwise). The therapeutic fluid (e.g., a therapeutic fluid containing the active ingredient) can be delivered to the well portion of the dental pad via a pumping system (e.g., an automatic pumping system), via vacuum, or via both. Preferably, while in the well, the therapeutic fluid substantially covers the natural crown of the tooth (e.g., the tooth being treated). Alternatively, while in the well, the therapeutic fluid substantially covers the portion of the gum tissue surrounding the crown of the tooth (e.g., the gum being treated).

A sealed compartment formed by the wells of the tooth covering surrounding the teeth (i.e., a sealed treatment cavity) can be used to deliver one or more treatment materials to the crowns of multiple teeth. For example, a series of two or more different treatment fluids can be passed through the sealed compartment. The treatment fluids can include (but are not limited to) one or more preparation fluids, one or more active treatment fluids (e.g., one or more whitening treatment fluids), one or more neutralizing fluids, one or more flushing fluids, or any combination thereof. Preferably, the treatment fluids include one or more whitening treatment fluids and one or more flushing fluids. The whitening treatment fluid can include any active ingredient known in the prior art for whitening teeth and/or any inactive ingredient. The whitening treatment fluid may include, but is not limited to, one or any combination of the features of the fluid compositions described in the following documents: U.S. Patent No. 7,189,385 (e.g., see column 1, line 2 to column 18, line 40); U.S. Patent No. 6,770,266 (e.g., see column 2, line 9 to column 6, line 35); U.S. Patent No. 6,746,679 (e.g., see column 1, line 13 to column 11, line 18); U.S. Patent No. 5,668,934 (e.g., see column 1, line 13 to column 11, line 18); 33 to col. 16, line 10); U.S. Patent No. 7,601,002 (e.g., see col. 1, line 11 to col. 16, line 8); U.S. Patent Application Publication No. 2008/0063612 (e.g., see paragraphs 11 to 165); U.S. Patent Application Publication No. 2005/0214720 (e.g., see paragraphs 10 to 102); and U.S. Patent Application Publication No. 2004/0185013 (e.g., see paragraphs 3 to 150); each of which is incorporated herein by reference. Any of the treatment fluids may be a liquid that flows under gravity, or a gel that does not flow under gravity. The treatment fluid preferably can be pumped and/or flowed under a vacuum. Preferably, any treatment fluid that may damage the soft tissues of the oral cavity (e.g., gums or other soft tissues) is in the form of a fluid or gel having a sufficiently high viscosity so that the fluid does not flow outside the sealed compartment surrounding the tooth being treated. For example, the viscosity of such a therapeutic fluid can be about 0.1 Pa·s or greater, about 1.0 Pa·s or greater, about 10.0 Pa·s or greater, about 100 Pa·s or greater, or about 1000 Pa·s or greater.

One or more of the treatment 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 according to the teachings herein, a high viscosity fluid may also be used), may increase the rate of peroxide decomposition to form oxygen free radicals from the gel, and thus increase the resulting whitening effect on the enamel surface of the tooth. Of course, other treatment materials may be used, including water, salts, gases, chemical and/or biological drug solutions, or other materials, compounds, etc. Each well (e.g., an arch well) of the dental covering may include one or more inlet holes for delivering the treatment material to each well (e.g., one or more inlet holes on each of the right and left sides of the dental arch), and an outlet (i.e., drain) hole (e.g., located at the front or at the back) for removing the treatment material from each dental arch well. The device may include multiple heating elements configured and controlled in such a manner that a control unit (e.g., a microprocessor control unit) independently controls the temperature of each heating element to form individually controlled whitening "zones" and/or predetermined patterns of customized whitening. The temperature control is preferably selected based on one or more characteristics of the patient (eg, initial color and/or initial color change).

The components, devices, systems, and methods according to the teachings herein can be advantageously used for accelerated dental treatments, such as accelerated whitening treatments. By employing a treatment fluid having a higher temperature, a higher concentration of an active ingredient (such as a peroxide), or both (e.g., a whitening fluid, such as a whitening gel), the rate of whitening can be increased, thereby accelerating the treatment. It will be appreciated that whitening treatment can be achieved without the need for photodynamic therapy. Accelerated dental treatment can be accomplished by heating the dental treatment fluid. While room temperature treatment can be employed, some or all of the treatment fluid is preferably heated to a temperature of approximately 27°C or higher, more preferably to a temperature of approximately 30°C or higher, even more preferably to a temperature of approximately 34°C or higher, even more preferably to a temperature of approximately 38°C or higher, even more preferably to a temperature of approximately 42°C or higher, and most preferably to a temperature of approximately 46°C or higher. Of course, higher or lower temperatures may be used as may be necessary. The treatment fluid in the treatment area (i.e., the sealed cavity formed by the tooth covering) may have a generally uniform temperature, or may have a varying temperature. A temperature difference can be advantageously employed between the two regions so that the two regions have different treatment rates. For example, the two regions within the sealed cavity can have sufficiently different temperatures so that the ratio of the whitening rate in the first region to the whitening rate in the second region is about 1.1 or greater, preferably about 1.3 or greater, more preferably about 2 or greater, and most preferably about 4 or greater. Of course, different whitening rates can be used as may be necessary. It will be understood that a similar increase in treatment rate can be achieved using a higher concentration of active ingredient in the treatment fluid in one or more (e.g., all) of the treatment regions.

Devices and systems according to the teachings herein can be used in a process that includes a step of measuring the natural pre-treatment (i.e., baseline) color characteristics of different teeth of a patient. The patient's treatment can be determined based on the color of the teeth, based on a difference in color of the teeth, or based on both. According to the teachings herein, the devices, systems, and methods of the present invention can be advantageously used in patients with variability in the natural pre-treatment (baseline) color values of different teeth to reduce such variability. In various aspects of the present invention, the ability to achieve a more uniform final whitening (i.e., the resulting color) is achieved by controlling the temperature of the whitening gel in multiple regions of the dental pad device (such as different regions of the tooth mantle), and thereby controlling its oxidative activity. Control of each region can achieve different variations in color (e.g., intensity of whitening) for different teeth, different surfaces of the teeth, or both. Heating elements can be positioned in various locations on the dental pad to allow for separate and differential heating of different surfaces of the teeth located in each region. For example, the positioning of one or more heating elements can be selected based on the measured color and/or color variation. One or more of these features can be used to achieve a more uniform final, aesthetically pleasing whitening effect.

The use of a controller that can independently control multiple treatment areas (e.g., whitening "zones") of a dental pad or otherwise affect the whitening pattern in each tooth covering layer of the dental pad can allow a dentist to customize the whitening process based on the patient's individual needs. The controller can allow the dentist to provide customized treatment in an automated manner.

The dental covering preferably has a peripheral portion made of a sufficiently soft material and arranged so that it will compress and deform to fit snugly against the sides of the alveolar gum ridges of the maxillary and mandibular teeth. The peripheral portion can thus form a sealed cavity (e.g., formed by the well of the dental covering) in which the crown of the tooth is received.

The improved bite block of the present invention may include one or more air breathing vents. Preferably, the breathing vents are designed to extend through the treatment supply layer of the bite block without compromising the ability of the treatment supply layer to flow one or more treatment materials into the wells (e.g., arcuate wells) of the tooth covering layer, without compromising the ability of the treatment supply layer to drain one or more treatment fluids from the tooth covering layer, or without compromising both. For example, the breathing vents may be integrally formed into the treatment supply layer in a manner that allows one or more treatment fluids to flow into and out of the bite block.

The sealing rim (preferably made of a soft, deformable material) can have a unique structural shape, such as a shape forming a highly deformable skirt or a circular hook-like design, which is used to seal the bite pad device of the present invention (e.g., a tooth cover) to the alveolar ridge. The seal can preferably be partially or completely achieved by the patient biting down on the bite pad. The sealing rim can effectively seal the wells of the tooth cover, thereby preventing the therapeutic material (i.e., therapeutic fluid) delivered to the bite pad from leaking into the oral cavity. The seal can be partially or completely achieved by applying a vacuum. For example, when a vacuum is applied, the sealing rim can be drawn against the sidewalls of the gum ridge. The therapeutic fluid pumped into the sealing wells of the tooth cover preferably contacts the corresponding teeth on the front surface, the top surface, the back surface, or a combination thereof. More preferably, the therapeutic fluid contacts the teeth on the front surface and the back surface. Even more preferably, the therapeutic fluid contacts the teeth on all exposed surfaces. The sealing effect of the highly deformable skirt and/or sealing rim can be achieved or enhanced by the therapeutic system's ability to remove (e.g., aspirate) air within the dental pad using an external pump so as to achieve a vacuum seal of the dental pad relative to the upper and/or lower alveolar ridges of the maxillary and/or mandibular jaws.

Due to the fact that dental arch lengths vary significantly between individuals, it can be difficult or even impossible to effectively seal the rearmost regions of the wells of the dental mantle using a universal, off-the-shelf dental arch. For example, it can be difficult or impossible to effectively seal the regions corresponding to the right and/or left distal teeth in any given dental arch. Without adequate sealing in these regions, treatment fluid may undesirably leak through these larger, unsealed openings to one or more sides (e.g., the right, left, or both) of either or both the upper or lower dental arch wells. Without some means of sealing these open regions, such unsealed openings (i.e., unsealed regions) may also prevent the formation and/or maintenance of a vacuum seal in the dental wells. Forming a vacuum seal between the dental mantle and the retromolar pad can present obstacles, such as the necessity of selecting or preparing a sufficiently long dental mantle and the potential for contact of the soft tissue of the retromolar pad with the treatment fluid. To overcome these obstacles, a vacuum seal in the rear portion of the dental mantle is preferably formed through the molars on each side of the dental arch. While this may limit the ability to provide dental treatment to one or more molars, the aforementioned benefits generally outweigh this problem. However, when sealing on molars, the need to form an adequate seal (e.g., for maintaining a vacuum) can present particular challenges. Surprisingly, an adequate seal has been achieved using unique distal plug inserts. In order to prevent such leakage of treatment material, and to allow the ability to form and maintain a continuous or selectively sustained vacuum in the bite pad, the various teachings of the present invention can be combined with one or more distal plug inserts (i.e., distal sealing plugs). The term "selectively sustained vacuum" can refer to the ability of the user or physician to determine how long to maintain the vacuum, to activate and release the vacuum multiple times in a treatment, etc. Preferably, the distal plug inserts are used with both ends of each tooth covering. The distal plug inserts can be designed and/or positioned to be uniquely attached to the left and right rear ends of the wells of the tooth covering. Preferably, the distal plug inserts effectively seal these openings. For example, when the patient bites down on the bite pad, the distal plug insert can seal the openings.

The distal plug insert is preferably made of a material that is sufficiently deformable so that the insert closely conforms to the contours of the variable dental anatomy of one or more of the posterior teeth, such as the right and left dentition (e.g., despite variability between individuals with respect to the length of their dental arches). The distal plug insert may be made of a polymeric material. A preferred polymeric material for the distal plug insert is an elastomeric (synthetic rubber) such that after being deformed, the distal plug insert generally returns to its original shape. The distal plug insert may be made of an elastomeric material. The elastomeric material has a crystallinity of about 0%, although elastomeric materials with higher crystallinity (e.g., about 0.5% or greater) may also be used. Preferred elastomeric materials have a crystallinity of about 15% or less, about 10% or less, or about 5% or less. The distal plug insert may be made of a foam material. Preferred foam materials have a closed-cell foam structure. Typically, the glass transition temperature of the elastomeric material is about 10°C or less, about -10°C or less, or about -40°C or less. The elastomeric material preferably has a sufficiently low hardness so that the distal plug insert can be deformed to conform to the surface of the molar. The Shore A hardness of the elastomeric material is preferably about 60 or less, more preferably about 50 or less, even more preferably about 40 or less, and most preferably about 30 or less. The elastomeric material of the distal plug insert may have a sufficiently high hardness so that the insert does not tear during storage and use. For example, the Shore A hardness may be about 2 or greater, about 5 or greater, or about 8 or greater. The elastomeric material is preferably sufficiently cured so that the material does not flow. The elastomeric material may be made of any polymer material, such as a polymer containing a carbon backbone or a polymer containing a silicon backbone. For example, the elastomeric material of the distal plug insert may include silicone rubber, such as RTV silicone rubber that can be vulcanized at room temperature, or HTV silicone rubber that can be vulcanized at one or more elevated temperatures. The elastomeric material can prevent the need to remove residual material after providing dental treatment (such as required when using wax or other moldable materials). Thus, the distal plug insert can function without the need for a moldable material. The elastomeric material can be a generally solid material (i.e., a porosity of about 10% by volume or less, about 5% by volume or less, or about 1% by volume or less). Such a material can be substantially free of, or completely free of, pores. Suitable elastomeric materials can be porous materials, such as having an open-cell foam structure, a closed-cell foam structure, or both.

The distal plug insert preferably has a sufficient width so that it can form a seal along the top surface of the molar from the back of the tooth to the front of the tooth. The distal plug insert preferably has a sufficient length so that it generally seals at least one of a person's molars, regardless of the length of the person's dental arch. Longer distal plug inserts may also enable a seal to be formed in people who have undergone molar extraction. The length of the distal plug insert is preferably about 2 mm or greater, more preferably about 4 mm or greater, even more preferably about 6 mm or greater, even more preferably about 8 mm or greater, and most preferably about 10 mm or greater. It will be appreciated that the distal plug inserts may be interchangeable such that a distal plug insert of sufficient length and/or width may be selected to provide an optional seal based on one or more characteristics of the patient's dental arch, such as its length.

Each dental arch dental pad device includes one or more treatment supply layers. The treatment supply layer can provide one or more treatment fluids to the dental covering layers, can provide heat to the dental covering layers, or both. If the dental pad includes two dental covering layers, each dental covering layer can have a separate treatment supply layer, or both dental covering layers can use a single treatment supply layer. For example, a single treatment supply layer can be positioned between the two dental covering layers. The treatment supply layer can include built-in flow channels or conduits through which one or more treatment fluids can flow. The flow channels or conduits of the treatment supply layer preferably pass through the entire layer of the dental pad. The treatment supply layer preferably has one or more (e.g., two or more) inlet holes for delivering fluid to the wells (e.g., sealed cavities) of the dental covering layers. The treatment supply layer preferably has one or more (e.g., two or more) outlet holes for removing fluid from the wells (e.g., sealed cavities) of the dental covering layers. It will be understood that the flow direction can be changed so that the outlet hole can be used as an inlet hole, so that the inlet hole can be used as an outlet hole, or both. A treatment supply layer used as an upper or lower tooth covering may have (1) one or more holes (e.g., inlet holes and outlet holes) located in the floor of the treatment supply layer for providing fluid communication with the cavity or well of the tooth covering of the lower teeth; and (2) one or more holes (e.g., inlet holes and outlet holes) located in the ceiling of the treatment supply layer for providing fluid communication with the tooth covering on the upper teeth. The flow channel or conduit preferably delivers and distributes one or more treatment fluids substantially evenly to the tooth covering. The treatment fluid can be any treatment fluid known in the art, such as described herein. For example, the treatment fluid can include a whitening material (such as a gel material), water, air, a medicinal material, a medical material, a cleaning material, an irrigation material, or any combination thereof. The treatment supply layer can be used to deliver one or any combination of the treatment fluids to the wells (e.g., dental arch wells) of the tooth covering. Thus, the treatment supply layer can effectively bathe one or more (e.g., all) of the surfaces of the teeth located in the wells and covered by the tooth covering with whitening gel or other treatment material. Preferably, the channels or conduits are capable of delivering and/or removing a variety of therapeutic fluids, such as water or air.

The components, devices, systems, and processes according to the teachings herein can be used in dental treatments to provide treatment to one or more teeth, to provide treatment to the gums, or both. These components, devices, systems, and processes can be used in applications such as tooth whitening, antibiotic treatment, antimicrobial treatment, fluoridation treatment, or any combination thereof. It will be appreciated that the features according to the teachings herein can be used in other applications in the dental field. Dental treatments can be generally short treatments, such as lasting about 10 minutes or less, or can be generally longer treatments, such as lasting greater than 10 minutes, preferably about 20 minutes or more, and more preferably about 30 minutes or more. It will be appreciated that the duration of a dental treatment is generally about 3 hours or less, more preferably about 2 hours or less, and most preferably about 1 hour or less. Dental treatments lasting greater than 3 hours are also contemplated (e.g., from about 3 hours to about 8 hours, such as during nighttime sleep). A vacuum can be applied to the tooth mantle 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). The dental covering component is surprisingly able to maintain the vacuum for such a long time even when the dental covering component is an off-the-shelf generic cover (ie, not a custom-made covering component).

As described above, according to some embodiments, a dental treatment system may include a pumping component for pumping one or more therapeutic fluids. For example, the pumping component may be in fluid communication with a dental pad according to the teachings herein. Preferably, the pumping component is in fluid communication with the therapeutic supply layer of the dental pad. The system may include a control unit for controlling the pumping component. The pumping component may be incorporated into the housing of an external control unit, or may be a separate component. The pumping component may include a heating chamber for preheating the therapeutic fluid to one or more predetermined temperatures. For example, a control unit including a microprocessor may monitor and/or control the temperature of the therapeutic fluid. Preferably, a feedback loop is employed for temperature control. Using temperature control, the temperature of the therapeutic fluid delivered to the dental pad can be controlled. The heating chamber may advantageously enable a practitioner to utilize a whitening fluid (e.g., a whitening gel) directly from a storage unit, thereby eliminating the need for the following steps: thawing the whitening fluid, warming the whitening fluid, preparing the whitening fluid for use in a dental treatment, or any combination of these steps. Therefore, a dental treatment process according to the teachings herein may include any combination of the aforementioned steps or may include all of the aforementioned steps.

The therapeutic delivery system may include one or more control valves, and preferably one or more multi-position flow control valves. The multi-position flow control valve is preferably in fluid communication with the pumping component. For example, the control valve may be incorporated into the pumping unit. However, the control valve may be located external to the pumping unit. The control valve may be manually operated or may be automatically operated. For example, the control valve may be motor driven, may be controlled by a controller, or may be both. The multi-position valve may be rotated to different positions, wherein each position of the valve allows a different flow path for the therapeutic material through the flexible tubing of the system. The valve may be rotated by being engaged by a drive shaft of a motor, the motor being controlled by a microprocessor unit or by other means. For example, the microprocessor may control the rotational position of the valve and thereby allow different flow patterns to be controlled depending on the position of the valve. Examples of flow patterns that can be achieved using control valves include: 1. providing a fluid connection between a vacuum line and a dental pad for removing air from the dental pad, for forming a vacuum seal with the dental pad relative to the gingival ridge, or for both; 2. providing a fluid connection between a treatment fluid and the dental pad for delivering the treatment fluid to a sealed cavity (e.g., a sealed cavity formed by a dental covering); 3. removing the treatment fluid from the dental pad; 4. forming a "closed loop" flow of the treatment fluid within the dental pad (e.g., where the flow is a dynamic, turbulent, or convective type of flow); 5. providing a fluid connection between an irrigation fluid (such as water or an aqueous solution) and the dental pad for delivering the irrigation fluid to the dental pad and removing the irrigation fluid from the dental pad (e.g., to rinse or flush the treatment fluid from the tooth surface and the inner surface of the dental pad); and providing a fluid connection between a neutralizing fluid and the dental pad for delivering the neutralizing fluid to the dental pad to neutralize the treatment fluid. One or any combination of the foregoing steps can be controlled by a single control valve or by multiple control valves.

A closed-loop flow pattern allows the treatment fluid to circulate within the present invention's dental pad device. This flow can be continuous or intermittent (e.g., pulsed or intermittent). For example, when the whitening fluid flows turbulently within the sealed cavity formed by the tooth covering, the amount of chemically active whitening fluid that contacts the tooth's enamel surfaces is significantly increased compared to a situation where the treatment fluid is delivered to the dental pad and held statically in place during whitening treatment. This convection-type flow of the treatment fluid around all of the tooth's enamel surfaces increases the whitening potential of a fixed volume of treatment fluid delivered to the dental pad. This is analogous to the higher heat flux when heating food in a convection oven. For example, by causing the treatment fluid contained in the dental pad device to flow turbulently around the teeth (much like the flow of hot air in a convection oven), the system significantly increases the volume of chemically active whitening fluid delivered to the dental pad and available for contact with all of the tooth's enamel surfaces. The increased volume of chemically active whitening fluid that contacts all of the tooth's enamel surfaces results in a significantly increased whitening effect of the fluid entering all of the tooth's enamel surfaces.

In another embodiment, the intermittent flow of a treatment fluid, such as a whitening fluid (e.g., a gel), in a dental pad device allows the fluid to remain stationary for a set period of time in a specific area or region of the dental tray between periods of active fluid flow during treatment. It will then be understood from the teachings herein that all or selected portions of the treatment fluid, such as the static whitening fluid in an area or region, can be heated to a specific temperature in that area or region of the dental tray by a separate heating element during the static fluid period. This can advantageously allow for different whitening activity in each area or region for each of these static periods, and therefore allow for different or "customized" whitening of the teeth located in each area or region of the dental pad device.

As described above, the flow of the treatment fluid can be controlled by a pump component (such as a pump component controlled by a microprocessor in an intermittent or pulsed manner for given time intervals). This allows for alternating static flow or convective flow of the treatment material (around the teeth) in the bite block device for a set period of time.

The systems and methods may employ one or more pressure sensors for measuring pressure in the conduit, for measuring pressure in the sealed cavity, for measuring pressure in a layer of the dental pad (e.g., a treatment supply layer and/or a dental covering layer), or for a combination of the foregoing. The pressure sensor may be incorporated into the control unit. The pressure sensor may monitor, for example, the vacuum level in the dental pad, one or more flow rates, the total amount of treatment material delivered to or alternatively removed from the dental pad assembly by the pump, or any combination of the foregoing. The sensor may also monitor the flow rate of the treatment fluid during a "closed loop" treatment cycle.

By maintaining a vacuum seal between the dental covering layer of the dental block and the alveolar ridge, peroxidases naturally present in saliva are substantially or even completely prevented from infiltrating or otherwise passing through the sealed cavity. This novel vacuum seal feature of the present invention effectively protects chemically active therapeutic fluids (such as whitening gels) from being chemically activated by peroxides of salivary enzymes. Because the chemical oxidation potential of the therapeutic fluid is substantially unaffected by saliva, the whitening effect of the present invention is enhanced.

It will also be appreciated that the pumping means can allow the treatment fluid to flow continuously into and out of the dental pad throughout the treatment. Thus, fresh, fully chemically active fluid can be delivered and applied to some or all of the enamel surfaces of the teeth within the tooth mantle throughout the treatment. When employed in a whitening treatment, this can significantly increase the whitening effect achieved within a set time period of the present invention, compared to a static, one-time delivery of treatment material (as in known tooth whitening methods).

According to some embodiments, flexible tubing can be connected to a pumping component from fresh and used therapeutic fluid containers, and a separate set of flexible tubing is connected to the pumping component, which in turn is also connected to separate inlet and outlet conduits integrally formed in the front portion of the bite block. These inlet and outlet conduits can be further integrally formed into the overall handle design of the bite block device. Such a pump that can come into contact with fluid already in a sealed cavity can be a disposable pump, thereby maintaining sterility. The pump can incorporate a locking and unlocking attachment feature for quickly attaching and removing an optional disposable pump to engage one or more motors contained in the control unit. Alternatively, a pump that pushes the therapeutic fluid, such as a peristaltic type pump component, can be used. Because such a pump component pushes the therapeutic fluid contained in the conduits, the pump component can be reusable because it does not come into contact with active therapeutic material.

The set of tubing from the pump assembly to the bite block device can be clipped to the patient's clothing, the patient's dental apron, or some element of the dental chair or other fixed point via a clip device or a small noose, thereby reducing or eliminating any drag on the bite block, so that the tubing is neatly managed, or both. The tubing and power cable can further be attached to a quick-attach connector that snaps into the integral handle of the bite block device of the present invention.

Another aspect of the present invention relates to a separate, disposable gum guard. The gum guard can be used in conjunction with a dental treatment fluid. The gum guard can be used during a tooth treatment process using one or more teeth whitening fluids. The gum guard provides a sufficient barrier to the gums, allowing for the use of highly active treatment fluids. The gum guard can be designed to be inserted into the alveolar ridge of the maxillary jaw, the alveolar ridge of the mandible, or both. The gum guard is preferably inserted into the mouth before the dental pad is inserted into the mouth. For example, the gum guard/shield can be used to isolate maxillary and mandibular gum tissue from a highly concentrated hydrogen peroxide whitening gel or other potentially harmful treatment material that will be delivered into the well of the dental pad device. The gum guard can provide sufficient gum protection, so the peroxide concentration can be approximately 15% or greater, approximately 25% or greater, approximately 35% or greater, or approximately 45% or greater.

The gum protection components can be provided as a kit including a plurality of gum protection components of different sizes. The gum protection components can be sufficiently flexible so that only a small number of different sizes of off-the-shelf, universal gum protection components are required to treat most patients. For example, the gum protection components in the kit can have about two or more different off-the-shelf sizes, preferably about three or more different sizes, and more preferably about four or more different sizes. The number of different off-the-shelf sizes is preferably about ten or fewer.

A separate and disposable gum protector (i.e., a gum protection component, or gum guard) may, in one embodiment, include two different layers that can be securely attached to each other. As an example, the body of the gum protector may be made of a stretchable polymer material. Preferred polymer 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 polymer materials have a sufficiently low tension set (tension set) such that the material returns to its original shape after being stretched. For example, the tension set (measured at room temperature 10 minutes after the material is stretched 200%) may be about 10% or less, preferably about 7% or less, more preferably about 5% or less, and most preferably about 3% or less. The polymer material may have a carbon-containing backbone or a silicon-containing backbone. The polymer material may be an elastomer. Examples of elastomers that can be used include silicone elastomers, natural rubber/latex materials, polyisoprene, styrene-butadiene rubber, SEBS rubber, or any combination thereof. The gum guard may have a chemical coating or layer applied and fixed to one or more of its surfaces. For example, a layer may be applied to the inner (proximal) surface of the gum guard so that the layer contacts the gum tissue.

The silicone and/or rubber body of the gum protector/guard may be shaped to mirror the horseshoe shape and ridges of the alveolar ridges of the maxillary and mandibular jaws in order to fit very closely to these oral structures.

The body of the gum guard/guard can be further modified to allow for multiple cutouts (either completely cut out or through-through for selective removal) along a portion of the guard that mirrors the location of the central ridgeline of the maxillary and mandibular teeth and alveolar ridges. The shape of these cutouts can mirror or conform to the scalloped form/shape of the gumline (interdental papillae) of the teeth to be treated.

The inner coating of the gum protector/guard as described above may comprise 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 thereby act as a chemical barrier to further protect the gum tissue from the attack of the therapeutic material. As described above, the gum protector/guard can provide an effective barrier to protect the gum tissue from even very high concentrations of therapeutic material (such as, for example, a 35% or even higher hydrogen peroxide whitening gel).

The optional disposable gum protector/guard described above can provide a flexible and snug fitting barrier to the gums and gum ridges that can be placed over the teeth and gums to be treated. When positioned in the dental arch in the mouth, the crowns of the teeth can protrude beyond the gum guard component while covering the gums. The fitted barrier (disposable gum protector/guard) is further formed to also allow for good fitting and sealing of the deformable well edge of a single arch dental pad device or a dual arch dental pad device relative to the upper and lower gum protectors/guards. This allows for good sealing of the treatment fluid being delivered to the dental pad device and prevents leakage of treatment material from the dental pad device into the oral cavity (while the gum guard protects the gums).

When used with a dental treatment layer, the gum guard further enhances the seal around the row of teeth through the unique, deformable flap skirt design and rim of the dental cover layer of the dental pad. This seal, combined with the unique distal sealing plug, enhances the pump's ability to draw air from the dental pad and create an effective vacuum seal against the outer wall surface of the previously placed gum guard. It will be appreciated that the upper and lower gum guards can be used to protect both the upper and lower gums.

This configuration and the relationship of these components to one another in the oral cavity effectively and safely isolates various concentrations of whitening agents applied to the teeth from the soft tissues (gums, tongue, cheeks, palate, oral mucosa), and thereby protects these soft tissues from the corrosive effects of even highly concentrated formulations of these chemicals during the improved whitening treatments of the present invention.

Embodiments of the disposable gum protector/guard allow its shape to be adjusted by the dentist to further adapt the inner edges of the multiple cutouts to the scalloped gum line. Varying the cross-sectional thickness of the gum protector/guard allows it to maintain its shape (thicker areas) and allows for thinner (tapered) edges of the cutouts and flossing area bands of the gum protector/guard.

This variable thickness design of the gum protector/guard allows the operator (using dental hand tools) to fold the thinner edge of the cut into the natural sulcus space that exists between the gums and teeth (typically 3 mm deep in healthy gum tissue), as well as into the flossing zone strip of the gum protector/guard adjacent to the teeth, and thereby provide a more effective fit of the gum protector/guard to the gum tissue and a better seal therebetween.

As mentioned above, other embodiments of the disposable gum protector may also include an inner coating that is a self-adhering coating when placed in contact with the gum tissue. These coatings may include various drugs or chemical compounds for medical delivery of these various drugs or compounds to the gum tissue. Further embodiments of the disposable gum protector/guard have broader dental and medical applications and may be used in any situation where a given medical/dental procedure is necessary or advantageous in what is known in the dental field as a "dry field." The gum protector/guard may be used in a variety of dental procedures as an alternative to what is commonly known in the dental field as a rubber dam.

Furthermore, because the disposable gum guard/guard is not integrally formed with the appliance, it can be provided in multiple stock sizes to match a given stock size bite block device and provide effective isolation of the gums and other soft tissues of the mouth from even highly concentrated formulations of therapeutic materials without the need for a custom bite block or gum guard for each patient, and without the need for manually applying hardening foam material as is commonly used in current professionally administered aggressive whitening procedures.

As described above, the disposable gum protector/guard can be a component that is itself an off-the-shelf product manufactured in a variety of off-the-shelf sizes, or alternatively, it can be manufactured as a custom device for each patient using molding and tooling techniques known in the art.

The single arch dental pad device or the double arch dental pad device may also include an outer heat barrier layer. This layer can be used to protect the patient from the heat generated by the activated multiple heating elements during the whitening treatment method of the present invention.

According to some embodiments, an optional tooth shade matching sensor unit may be incorporated into the control unit, which may be used to record pre-treatment and/or post-treatment tooth shade values.

As is well known in the medical field, pulse rate can be used to monitor a subject's pain/discomfort level. An optional adjustable strap, such as a wrist strap, can be placed on the patient, the wrist strap being attached to the control unit and containing sensors for monitoring certain vital signs of the user (such as the patient's pulse rate) throughout the whitening treatment, and thereby monitoring the patient's comfort level throughout the treatment.

Another aspect of the present invention relates to a kit comprising a plurality of dental pads, such as a plurality of dental pads according to the teachings herein. The kit preferably comprises off-the-shelf universal (i.e., not custom-made) dental pads, and includes dental pads of different sizes. The kit may include dental pads of different widths for use with mouths having dental arches of different widths (e.g., as measured between respective left and right molars). The kit may include dental pads having dental arches of different lengths. It will be understood from the teachings herein that the use of distal sealing plugs can reduce or eliminate the need for dental pads of different lengths. By employing a kit comprising off-the-shelf universal dental pads, the need for custom production of dental pads (e.g., using dental mold impressions) can be eliminated. The kit may include pre-assembled dental pads, or may include off-the-shelf universal dental coverings, such as dental coverings according to the teachings herein. The kit may include dental coverings suitable for the lower dental arch, the upper dental arch, or both. The kit preferably includes dental coverings of different widths for use with individuals having dental arches of different widths. The kit may include one or more treatment supply layers, such as treatment supply layers according to the teachings herein. The treatment supply layer may be adapted to be connected to one or two dental covering layers. By employing a distal sealing plug in the dental covering layer that is adapted to seal the rear end of the dental arch, the need for dental covering layers having different lengths may be reduced or eliminated. Preferred kits include dental pads and/or dental covering layers having two or more different off-the-shelf sizes, more preferably three or more different off-the-shelf sizes, and most preferably four or more different off-the-shelf sizes. The number of different sizes may generally be larger, but is preferably about 20 or more, more preferably about 10 or less, and most preferably about 6 or less.

Treatment

Provided herein are methods for performing dental treatments, which, according to some embodiments, may include one or more of the following steps: positioning a dental pad comprising one or more dental coverings on upper and/or lower teeth; applying a vacuum to the dental coverings to form a sealed treatment cavity around the teeth, the sealed treatment cavity having a pressure lower than ambient pressure; and flowing one or more treatment materials into the sealed treatment cavity.

In a further embodiment, a method for performing a teeth whitening treatment is provided, wherein one or more of the following steps may be performed: configuring a process for simultaneous customized teeth whitening; configuring a pump module to connect to a bite block designed for teeth whitening treatment; configuring treatment settings on a control device coupled to the pump module; positioning the bite block in the patient's mouth; applying flow control to create a vacuum between the bite block and the patient's gingival ridge structure; applying flow control based on the treatment settings to automatically manage the delivery of material; and removing the treatment material from the bite block using the flow control. Of course, other steps or combinations of steps may also be used. For example, prior to treatment, a baseline shade of each tooth may be measured to implement customized treatment for each tooth. Additionally, a dental impression may be taken to implement the configuration of the patient's specific bite block. In some cases, a gum guard may be used in addition to the bite block, which may be a customized or off-the-shelf type. In other cases, the treatment material may be preheated prior to treatment and/or heated as needed during treatment.

Reference is now made to the various drawings, which illustrate elements or aspects of various embodiments of the present invention. The drawings are provided for illustration purposes only and are not meant to be limiting.

FIG1A is a top view of an example of a dental pad device 1, showing an arch-shaped covering layer, sometimes referred to herein as a vacuum-forming layer, made of a flexible material, wherein a compressible rim is designed to form a treatment cavity on the upper teeth and upper gingival ridge or on the lower teeth and lower gingival ridge, hereinafter referred to as the upper arch well or lower arch well 2. In other words, the negative space contained between the arched walls in the form of a well forms what is referred to herein as a treatment cavity. The arch well 2 may, for example, include a deformable rim 2a, an upper well base 2c, an upper lip-shaped frenulum cutout 2b in the outer wall of the rim 2, and an upper distal deformable plug seal 7 (with its bolt hole 7a). Also shown is a portion of an intermediate arch layer, which is designed to provide customized treatment material to the vacuum-forming layer and remove customized treatment material from the vacuum-forming layer, and the intermediate arch layer is referred to herein as the intermediate layer or treatment supply layer. The intermediate layer may support, for example, an integrally formed handle 9, heat transfer pin heads 17, 17a, bow well material delivery aperture 13, material discharge recess aperture 14a, one or more electrical connectors, or any combination thereof. The electrical connector may be a printed circuit board 15. The handle 9 may be designed to facilitate positioning the bite block in the patient's mouth, delivering material to the bite block, extracting treatment material from the bite block, and delivering power to the bite block. For example, the handle may include one or more features to facilitate its operation, such as a thumb recess 9a.

Figure 1B is a bottom view of an example of a dental pad device 1, showing the distal plug seals 8 and their bolt holes 8a, the arch well treatment material delivery holes 13a, the discharge recess holes 14a, the vacuum-forming layer in the shape of the lower dental arch, which is hereinafter referred to as the lower dental arch well 3, the lower dental arch well having its deformable edge 3a, the lower base well 3c, the lower lip frenulum cutout 3b, the distal sealing wall 3d of the lower dental arch well 3, the distal sealing wall 2d of the upper dental arch well 2, and the printed circuit board 15.

1C is a view of an example of a dental pad device 1 showing an upper dental arch shaped vacuum formed layer, or dental arch well 2, having a material delivery hole 13, a drainage recess hole 14a, a drainage channel hole 19a, a arch well bolt hole 16a, and a arch well heat transfer pin hole 17b.

2A is a front view of an example of a bite block device 1 showing the upper arch well 2, the lower arch well 3, the middle layer 4, the inflow conduit 10, the outflow conduit 11, and the air breathing vent 12.

Figure 2B is a side view of an example of a dental pad 1, showing an integrally formed handle 9, an upper dental arch well 2, a lower dental arch well 3, and an intermediate layer 4. In some embodiments, the shape of the intermediate dental arch layer is formed to be mirrored at a hinge axis angle to facilitate natural jaw movement when using the upper vacuum-forming layer and the lower vacuum-forming layer. This angled hinge axis design of the dental pad 1 is suitable for directly involving the hinge axis relationship of the lower jaw relative to the upper jaw. The angle of the angled hinge axis design of the dental pad (e.g., the angle between the two vacuum-forming layers) is preferably such that it remains comfortable for the patient during dental treatment. Preferably, the angle is about 0.5° or greater, more preferably about 1° or greater, and most preferably about 2° or greater. Preferably, the angle is about 20° or less, more preferably about 15° or less, even more preferably about 10° or less, and most preferably about 7° or less. It will be appreciated that greater angles may be advantageously employed to allow for larger breathing vents, to allow for more flexibility in the design of the intermediate layer, or both.

2C is a top view of an example of the intermediate layer 4, showing the intermediate layer top therapeutic material channel base 4a and its flow channel sidewalls 4b, the therapeutic material inlet hole 13, the heating element 18, the heat transfer pin 17, the connector plug 16, the printed circuit board 15, and the inflow conduit 10 and the outflow conduit 11 integrally formed in the handle 9.

FIG2D is a bottom view of an example of the intermediate layer 4, its channel sidewalls 4b, and the bottom therapeutic material flow channel substrate 4c. Also shown is the drain channel 19 and its drain or outflow opening 20, which is connected to the outflow conduit 11, the therapeutic material inlet port 13, the connector plug 16, and the air breathing vent 12.

FIG3 is an enlarged top view of an example of a front section of the intermediate layer 4, showing the drain holes 19 and the drain conduit 20 connected to the outflow conduit 11, the head 17a and the pin end 17b of the heat transfer pin, and the heating element 18. The heating element is preferably inserted into or otherwise connected to the printed circuit board 15. The connection between the heating element 18 and the printed circuit board can be located below the base of the flow channel. Also shown is the air breathing vent 12. The connection between the heating element 18 and the printed circuit board 15 can be located below the base of the channel so that the connection is isolated from any fluid flowing through the channel.

4A is a front (labial) view of the example, showing the midlayer 4, midlayer upper cover plate 5, midlayer lower cover plate 6, air breathing vents 12, and inflow duct 10 and outflow duct 11.

FIG4B is an interior (lingual) view of FIG4A showing an example of the interior aspects of the air breathing vent 12, the intermediate layer upper cover plate 5 with its connector peg holes 5b and its heat transfer pin holes 5a, and the drain hole recessed well 14. Also shown are the connector pegs 16 for securing the upper and lower cover plates 5, 6 to the intermediate layer 4, and the therapeutic material entry holes 13 that allow therapeutic material to flow from the therapeutic material flow channels 4a and 4c located within the intermediate layer 4 to the upper and lower dental arch wells 2, 3 (not shown). Also shown are the air breathing vents 12 that pass through the body of the intermediate layer 4.

FIG4C is a front (lip view) view of an example of the structural connection of the upper cover plate 5 and the lower cover plate 6 (with the intermediate layer omitted) and the heat transfer pins 17 located between the upper cover plate 5, the lower cover plate 6, and the printed circuit board 15. Also shown are the connector key holes 5b of the upper cover plate 5 and the drain hole recess 14 of the upper cover plate 5.

5A is an exploded front (buccal) view of a vertical stack of components comprising one possible embodiment of a dual-arch dental aligner 1 of the present invention, showing an upper flexible dental arch well 2, a lower flexible dental arch well 3, an intermediate layer 4, a lower cover 5, an upper cover 6, an upper distal plug seal 7, and a lower distal plug seal 8. Also shown are heat transfer pins 17 and a printed circuit board 15.

FIG5B is an exploded rear (lingual) view of the vertical stack of FIG5A , showing the components comprising the dual-arch dental pad 1 of the present invention, showing the upper flexible dental arch well 2, the lower flexible dental arch well 3, the middle layer 4, the lower cover 5, the upper cover 6, the upper distal plug seal 7, and the lower distal plug seal 8. Also shown are the heat transfer pins 17. The printed circuit board 15 is not shown in this figure.

6A is an internal (lingual) view of an example of a bite block device 1 showing the upper arch well 2, lower arch well 3, upper and lower distal plugs 7, 8, and air breathing vent 12. FIG.

FIG6B shows the view of FIG6A , wherein a vertical cross-section of the distal end of the dental pad device 1 has been cut to remove the distal sealing walls 2 d and 3 d of the upper and lower dental arch wells, respectively, thereby revealing the cross-sectional structure of the skirt portion or curled cross-sectional shape design 21 of the rim 2 a of the upper and lower dental arch wells 2 and 3. Additionally, the cross-sectional shapes of the upper and lower distal plugs 7 and 8 and their structural relationship to the upper and lower dental arch wells 2 and 3 are also revealed.

Figure 6C shows 6B with the upper and lower distal plugs 7, 8 removed to more clearly reveal the structural shapes of the highly deformable outer and inner curled skirts 21, 21a of the upper and lower edges 2a, 3a of the dental arch well.

FIG6D is an interior (lingual) view of the intermediate layer 4 with the upper and lower cover panels 5, 6 attached, to which the upper and lower distal plug seals 7, 8 have been secured. Also shown are the drain well 14 located on the upper cover panel 5, the plug connector 16 inserted through the upper cover panel hole 5a, and the upper cover panel hole 5b that accommodates the heat transfer pin head 17a (not shown). Additionally, the figure shows the air breathing vent 12.

FIG6E is an angled front view of the bite block device 1, showing the bite block in an array of three embodiments, wherein the leftmost embodiment shows the inflow tube 10 and the outflow tube 11, and the middle embodiment shows the attachment of a quick-attach connector 22, which has an integrated hole 22a aligned with the inflow tube 10, a hole 22b aligned with the outflow tube 11, and a hole 22c aligned with the printed circuit board 15 (not shown). The rightmost embodiment also shows a cable/tube bundle 23, which is inserted into the quick-attach connector 22 and includes an outflow tube 23b, an inflow tube 23a, and a power cable 23c.

Figure 7 is an enlarged internal (lingual) view of an example of a dental pad 1, showing the upper dental arch well 2 (highly deformable outer skirt 21 and inner skirt 21a with compressible rim 2a), the lower dental arch well 3 (highly deformable outer skirt 21 and inner skirt 21a with compressible rim 3a), the intermediate layer 4 (with its air breathing vents 12), and the connecting pins 16 (which fix the upper dental arch well 2 and the lower dental arch well 3 to the intermediate layer 4).

FIG8A is a front (labial) view of an example of a bite block 1, showing the upper and lower dental arch wells 2 and 3, which are made of a see-through flexible material, to reveal their coverage of the maxillary teeth 28 and maxillary alveolar ridge 26 of the upper jaw 24, and the mandibular teeth 27 and mandibular alveolar ridge 26a of the mandible 25, respectively. Also shown are the middle layer 4 of the bite block device 1, and the inflow and outflow conduits 10 and 11 of the bite block device 1.

FIG8B is an enlarged view of the inside (the surface facing the not-shown bite block 1 ) of the quick attach connector 22 , showing the interior aspects of the holes 22 a and 22 b , and the printed circuit board connector 22 d .

8C is an enlarged outer side (the surface facing away from the not shown bite block 1 ) of the quick attach connector 22 , showing the exterior aspects of holes 22 a , 22 b and 22 c , and thumb recess 22 e on the top surface of the coupler 22 .

9A is an angled view of one side of an example of a pump mechanism assembly 30 showing a flow control valve assembly 32 (inserted into a control valve assembly frame 39), a flow control valve motor 33, a gear assembly 34 (inserted into a gear assembly frame 42), a flexible pump membrane 36 (inserted into a hole 38 of the flow control valve assembly 32), and a piston 41 (attached to a drive shaft coupler 40). An example of a therapeutic material dispenser is shown, such as a fresh gel line 32b connected to a fresh gel container 46 (not shown) and a pump motor 31 (inserted into a pump mechanism assembly base 43).

Figure 9B is an angled view from the opposite side of Figure 9A, showing the outflow conduit 32a, the treatment material conduit 32b, the pump jumper conduits 32c and 32d, the pre-heating chamber 29 (along with its treatment material conduit 29a), the heat transfer block 44 (along with its heating element 45), the waste conduit 32f and the flush conduit 32g, and the pump motor 31.

9C is a top view of the pump mechanism assembly 30 showing a perspective view of the flow control valve assembly 32 revealing the multi-position flow control valve 35 having a plurality of apertures 35a within the flow control valve assembly 32. Also shown are the preheat chamber 29 (along with its therapeutic material conduit 29a attached to the multi-position flow control valve 35), the gear assembly 34, the flow control valve motor 33, and a plurality of locating apertures 37 on the top surface of the drive shaft coupler 40.

FIG9D is a front view of the flow control valve assembly 32. The flow control valve assembly 32 includes an outflow conduit 32a and a therapeutic material conduit 32b. The flow control valve assembly 32 includes pump jumper conduits 32c and 32d. The flow control valve assembly includes a preheating chamber flow attachment 32e for attachment to the preheating chamber 29 (not shown). The flow control valve assembly 32 further includes a waste conduit 32f and a flush conduit 32g.

10 is a top/front view of one possible embodiment of the control unit 50 showing the interactive screen 49, interface buttons 50a, emergency stop button 50B, speaker 50c, optional rechargeable battery pack or power supply 48, a treatment material station (e.g., gel container station 47 (not shown in this figure) attached to gel container 46), inflow (to the bite block device 1) conduits 23a and outflow 23b, and a power cable 56 (with a quick harness clip 51 attached along with its clip 51a for managing the inflow and outflow conduits 23a, 23b).

FIG11 is a top/rear view of the control box 50 and the battery pack charging unit 52. Also shown are the inflow and outflow pipes 23a and 23b, the fresh water container 55, and the waste water container 53, with their weight pressure sensors 54 located on the base of the water container compartment 57 of the control unit 50. Also shown are the power cable 56, the battery pack 48, the battery charging plug 52a, and the therapeutic material container 46.

Figure 12A is an exterior surface (bottom) view of one possible embodiment of an upper gum guard 59 showing an outer base 59d having multiple tooth apertures 59a of varying diameters and spacings, an outer side wall 59b, and an upper lip frenulum notch 59c.

12B is an interior surface (top) view of FIG. 12A showing interior aspects of tooth aperture 59a, inner sidewalls 59e, and inner base 59f, which in certain embodiments may be coated with a neutralizing layer 61 of a therapeutic material.

FIG. 12C is an exterior surface (top) view of one possible embodiment of a lower gum guard 60 showing an exterior base 60d having multiple tooth apertures 60a of varying diameters and spacing, and an exterior sidewall 60b.

Figure 12D is an interior (bottom) view of Figure 12C showing the interior aspects of tooth aperture 60a, as well as inner sidewalls 60e and inner base 60f, which may be coated with a therapeutic material neutralizing layer 61. Also shown is a lower lip frenulum incision 60c.

FIG. 13A is a front view of a vertical stack of upper and lower gum guards 59 and 60 .

Figure 13B is a front view of the upper jaw 24 and the lower jaw 25, showing the upper gum guard in perspective form, which has been pulled over the maxillary teeth 28 and placed on the upper alveolar ridge 26, and the lower gum guard 60 in perspective form, which has been pulled over the mandibular teeth 27 and placed on the lower alveolar ridge 26a.

FIG13C is a front view of an example of a bite block device 1 inserted between an upper jaw 24 and a lower jaw 25, respectively, and showing the upper and lower arch wells 2 and 3 of the bite block 1. Also shown are the upper and lower gum guards 59 and 60 on which the bite block 1 rests. Furthermore, the figure shows the bite block handle 9 with the quick-attach connector 22 attached, which has a cable/tubing bundle 23 attached thereto.

Figure 14 is a flow chart of an example of performing a teeth whitening treatment using a dental pad and associated components as described herein according to some embodiments. In step 14A, at the time of the first visit, the dentist or dental staff determines and records the current (reference) color of the teeth to be whitened. This can be accomplished by using an optional shade guide comparison sensing device (the shade guide comparison sensing device can be provided with a control unit) or a replaceable shade comparator. If necessary, in step 14B, an initial dental impression of the dental arch of the tooth to be treated can be obtained, or a dental calculus model of the dental arch can be poured as known in the art. These models can then be used to manufacture a customized disposable gum protector as described above. Alternatively, gum protectors/guards of various stock sizes can be used in conjunction with matching stock size dental pad devices without obtaining dental impressions or making dental calculus models. In step 14C, a customized or appropriate stock dental pad is provided, assembled and selected based on a good match to the patient's mouth.

During the treatment visit, in step 14D, the system is calibrated and the treatment materials are prepared. For example, a container of fresh gel can be connected to a disposable pump assembly already inserted into the control unit, and fresh water can be filled into the refillable fresh water container. In step 14E, disposable gum protectors/guards can be applied and fitted to the gums and/or alveolar ridges of the upper and lower jaws and adapted to the teeth to provide a sealed barrier between the teeth and the soft tissue immediately surrounding them. If a lower concentration of treatment material is used, a gum protector/guard may not be required. In step 14F, the relevant tubing is connected to the treatment material container and pump mechanism. Disposable tubing is now also connected to the bite block device, and the disposable tubing may include a harness, clip, or other attachment element to maintain the tubing in a specific orientation and position relative to the bite block device and the patient. In step 14G, the control unit is powered on and the treatment settings are configured. Configuring the treatment settings may include, for example, configuring a customized treatment plan or course of treatment for the patient based on their specific whitening needs or desires, comfort zone, and health status.

In step 14H, the treatment material can be preheated in the heating chamber of the pump mechanism. In step 14I, the bite pad is inserted into the mouth, and the patient can be instructed to close their mouth and bite down on the bite pad. In step 14J, the control unit can apply flow control to create a vacuum around the alveolar ridges. For example, the control unit can activate a motor, which then turns a flow control valve to a vacuum position, thereby activating a pump to extract air contained between the bite pad and the maxillary and mandibular alveolar ridges against which the bite pad rests. This negative pressure within the bite pad creates a vacuum seal against these ridges because the thin, flexible rim or skirt of the bite pad is drawn tightly against and conforms to the gums, thereby covering the oral and lingual plates of the maxillary and mandibular alveolar ridges. This vacuum seal can be monitored throughout treatment by a pressure sensor. In some embodiments, if the vacuum seal is broken, the control unit can alert the user of the loss of vacuum integrity.

At step 14K, the control unit may apply flow control to enable delivery of the therapeutic material. For example, the control unit may activate a motor, which then rotates a flow control valve to a therapeutic material delivery position, and then also activate a pump component to deliver a selected amount of therapeutic material to the bite block assembly at a controlled rate, wherein the selected amount of therapeutic material has been preheated to a set temperature by a heating element contained in the control unit, which is in contact with a heating chamber element of the pump assembly. In some embodiments, various other changes may be made during treatment, such as heating the therapeutic material within the bite block, or otherwise managing the timing, material, temperature, lighting, etc., of the treatment environment.

At step 14L, the control unit continues to monitor the treatment settings during treatment. For example, the control unit may monitor various pre-configured settings, such as flow rate, temperature of the individual heating elements in the dental pad, material composition, exposure intervals, and the like. For example, a pump assembly may pump pre-heated whitening gel into an internal well of the dental pad device, and the flow rate and total amount of gel dispensed and delivered may be controlled by pressure sensors or other sensors within the microprocessor controller of the overall system and control unit. In some cases, for example, the microprocessor may further control various temperature outputs of each of the multiple heating elements in the dental pad during treatment.

In some embodiments, a pressure sensor may be incorporated into the pump mechanism to monitor the internal pressure within the bite block device throughout treatment. In one embodiment, increasing the pressure inside the bite block means a degradation of the vacuum seal integrity and increases the potential risk that treatment material will leak out of the bite block and into the patient's mouth, or alternatively, allow saliva to enter the bite block. Both possibilities are undesirable.

Chemically active therapeutic materials (such as whitening agents) can release, for example, oxygen during their oxidation/whitening reaction. The release of free oxygen from the gel can increase the internal pressure within the bite pad device. In some embodiments, if the internal pressure (which is monitored by a pressure sensor and microprocessor) reaches a critically high value, the patient can be told to bite down harder on the bite pad, and the system will automatically begin to expel the therapeutic material contained within the bite pad and pump in water to rinse the teeth or alternatively pump in new therapeutic material. Alternatively, removing over-activated therapeutic material present in the bite pad with fresh therapeutic material can help to reduce the internal pressure within the bite pad and thereby allow continued treatment without the need to rinse the teeth.

In step 14M, the microprocessor can activate the flow control to change the flow pattern as may be needed. For example, the motor can be activated to rotate the control flow valve to a position that allows a "closed loop" flow of the treatment material that has been delivered to the dental pad so that the treatment material circulates throughout the upper and lower dental arch wells of the dental pad in a steady flow pattern or in intermittent pulses. In some implementations, the direction of flow within the dental pad can also be alternated to form further dynamic turbulence of the treatment material, similar to the convection flow of a gas or liquid. In some embodiments, as may be needed, additional treatment therapies can be applied during the treatment by manual operation of the physician or assistant and/or via programming of the control unit. For example, each whitening treatment for the same patient may require multiple applications of fresh gel because the amount of gel material used to fill the dental pad device to a specific level in each well is limited in the chemical reaction potential for releasing oxygen free radicals and thereby achieving whitening of the teeth.

In further embodiments, the microprocessor of the control unit can be configured to monitor, optionally in real time throughout the treatment, the duration of the treatment and/or the temperature settings for each zone or area of the dental pad device, the patient's condition, and the like. In some embodiments, a built-in screen in the control unit displays this data to the user or physician throughout the whitening process. In some embodiments, an alarm can be generated, as may be necessary, to warn the physician of any problems, dangers, complications, and the like. For example, the control unit can alert the operator when each gel application treatment is complete, or warn of an undesirable gel volume in the dental pad, gel temperature, vacuum pressure value, and the like, by a beeping sound, a voice-activated message, and/or an illuminated indicator light.

At the end of treatment, at step 14N, the control unit can apply flow control to remove and/or flush out the treatment material. For example, to facilitate removal of spent whitening gel (which is chemically deactivated or inactive) from the well of the bite block assembly, the microprocessor can activate a motor, which then rotates the flow control valve to a position that allows the system's pump mechanism (which has also been activated by the microprocessor) or a separate suction device shared by the dental operatory (which is connected to the bite block assembly, such as might be used in the event of a sudden failure of the pump or control system, or both) to substantially remove spent or remaining gel material from the bite block assembly. Alternatively, spent, chemically inactive treatment material can be simply replaced by pumping new treatment material into the bite block. In some embodiments, to remove any remaining spent whitening gel from the tooth surfaces and interior surfaces of the bite block, fresh water can be pumped into the treatment area, for example, from a removable container of fresh water that includes and is connected to the pump and flow control valve unit. Water can be delivered to the interior of the dental pad through these same flexible conduits, and the water can be used to rinse or flush the remaining spent treatment material into a separate disposal container. In one example, a sensor (such as a simple weight sensor or other type of sensor) can be incorporated under or near the water disposal container to monitor the amount of water used in each rinse/flush cycle.

At step 14O, the flow control valve may be activated to release the vacuum seal of the bite block against the alveolar ridge and teeth, for example, by pumping air into the bite block.

At step 14P, the bite block and gum guard (if used) are removed from the patient's mouth, and an optional shade comparison device may be used to record the whitening effect achieved.

The aforementioned features of the present system allow for easy and rapid removal of treatment material from the bite block device, resulting in virtually no residual treatment material remaining in the bite block device itself or on the enamel surfaces of the treated teeth when the bite block device is removed from the patient. This simplifies the operator's task of removing any partially or completely spent treatment material from the patient's mouth. In some implementations, controlled removal of spent treatment material can be performed automatically by the control unit at the end of a set time period, or can be manually initiated at any time during treatment by the operator pressing a button for initiating removal/aspiration of treatment material.

Alternatively, as described above, spent treatment material may be quickly removed (aspirated) by the vacuum system of a standard dental operating unit.

In some embodiments, multiple applications of fresh treatment material (applying the volume of gel required to fill the dental pad) can be applied and removed until the operator and patient are satisfied with the whitening results achieved. Of course, any combination of the above steps can be performed. In addition, other steps or series of steps can be used.

In various embodiments of the present invention, the above-described design elements allow for rapid, intense, and controlled whitening of one or more dental arches of both anterior and posterior teeth simultaneously, and allow for whitening of the external (buccal view), internal (lingual view), and occlusal (apical/biting) surfaces of both anterior and posterior teeth. These embodiments further enable effective protection of the patient's soft tissue from the corrosive effects of various concentrations of whitening agents applied to the teeth, while optionally maintaining and monitoring the patient's safety, progress, and/or comfort in real time throughout the treatment.

According to some embodiments, the dental arch bite block design of the present invention allows for a novel "compression" whitening technology (based on its novel vacuum-sealed integrity in the mouth) that enhances the oxidation (whitening) effect by forcing oxygen ions into the enamel surface of the teeth. As mentioned above, this compression technology also protects the whitening gel from inactivation by salivary peroxidase, thereby further enhancing the whitening effect of a given amount of gel delivered to the interior of the present bite block device.

It will be understood that for simplicity and clarity of illustration, the elements shown in the drawings are not necessarily drawn to scale. For example, the dimensions of some elements may be exaggerated relative to other elements for clarity. Furthermore, where deemed appropriate, reference numerals may be repeated among the drawings to indicate corresponding or similar elements throughout the series of views.

The principles and operations of the apparatus and method according to the present invention may be better understood with reference to the accompanying drawings and the following description. It should be understood that these drawings are provided for illustration purposes only and are not intended to limit the present invention.

The foregoing description of the embodiments of the present invention is provided for the purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed. It will be appreciated by those skilled in the art that many modifications, variations, substitutions, alterations, and equivalents may be made in light of the above teachings. Therefore, it will be understood that the appended claims are not intended to cover all such modifications and variations that fall within the true spirit of the present invention.

Claims (15)

1. A dental device comprising: Dental splints, suitable for performing dental treatments, wherein the dental splints include: i. One or more off-the-shelf dental overlays adapted to form a vacuum-sealed treatment cavity, wherein the dental overlays comprise layers on the upper teeth and/or gingival ridges and/or layers on the lower teeth and/or gingival ridges, and the vacuum-sealed treatment cavity is formed using a continuous sealing mechanism comprising a sealing edge coupled to at least one sealing plug, the sealing edge being formed of a compressible material, the at least one sealing plug for sealing the posterior opening of each dental overlay, whereby the sealing edge and at least one sealing plug adequately seal the treatment cavity to allow the pressure within the treatment cavity to be reduced below ambient pressure and, when a vacuum is applied, to provide a fluid seal to selectively allow or prevent the inflow and outflow of treatment fluid into and out of the treatment cavity; and i. One or more treatment supply layers, wherein the treatment supply layer has one or more flow channels in fluid communication with the treatment cavity, thereby enabling the treatment supply layer to deliver one or more treatment fluids to the treatment cavity and/or remove the one or more treatment fluids from the treatment cavity. 2. The dental device of claim 1, wherein each of the sealing plugs is formed of a sufficiently deformable material, such that, despite differences in arch sizes, the sealing plug closely conforms to the anatomical profile of one or more posterior teeth, thereby allowing selection of sealing plugs of sufficient length and/or width to provide an optimal seal based on one or more characteristics of the patient's arch and/or different end tooth sizes. 3. The dental device of claim 1, wherein the treatment supply layer comprises a plurality of zones, each zone being heated by a different heating element; and an optional control unit for independently controlling the temperature of the heating elements, such that the plurality of zones have the same or different predetermined temperatures. 4. The dental device of claim 1, wherein the treatment supply layer has multiple regions provided with different concentrations of active ingredients. 5. The dental device of claim 1, wherein the device includes a handle integrally formed in the treatment supply layer, the handle being adapted to: insert one or more of the tooth cover layers onto upper and/or lower teeth, to adjust the position of one or more of the tooth cover layers and/or to remove the tooth cover layers after dental treatment is completed; The handle includes: one or more inflow conduits for allowing one or more therapeutic fluids to flow into the therapeutic supply layer; and one or more outflow conduits for allowing one or more therapeutic fluids to flow out of the therapeutic supply layer. 6. The dental device of claim 1, wherein the device comprises: two tooth covering layers for covering the upper teeth and the lower teeth respectively; at least one treatment supply layer between the two tooth covering layers to allow the upper teeth and/or gingival ridges and the lower teeth and/or gingival ridges to be treated simultaneously; wherein the device includes one or more breathing vents located in the treatment supply layer, the breathing vents being adapted to provide air passage to the mouth during dental treatment. 7. The dental device of claim 5, wherein the dental pad comprises: one or more delivery orifices for allowing treatment fluid to flow from the treatment supply layer to the treatment cavity; and one or more discharge orifices for allowing treatment fluid to flow from the treatment cavity to the treatment supply layer; and wherein the treatment supply layer comprises: one or more delivery channels for transporting treatment fluid from an inflow conduit to the treatment cavity; and one or more discharge channels for transporting treatment fluid from one or more discharge orifices to an outflow conduit. 8. The dental device according to any one of claims 1 to 6, wherein the device comprises one or more of the following elements: a tooth overlay including an incision margin conforming to the curl of the gingival ridge; the treatment supply layer including one or more individually controllable heating zones; and a dental treatment layer located between the upper and lower tooth overlays, wherein the dental treatment layer is shaped to be mirror-image at a hinge axis angle to facilitate natural jaw movement. 9. The dental device of claim 1, wherein the vacuum is formed via the treatment supply layer by reducing the pressure in the sealed treatment cavity to below ambient pressure. 10. The dental device of claim 1, wherein the device further comprises: i. A pumping system for pumping one or more therapeutic fluids into the dental pad; ii. Multi-position flow control module; and iii. Control unit for automating dental treatments. 11. The dental device of claim 1, wherein the device includes a dental gingival protector for providing additional protection against the effects of treatment fluids. 12. The dental device of claim 11, wherein the dental gingival protector includes a gingival treatment layer on its inner surface for delivering one or more therapeutic fluids to the gingiva. 13. The dental device of claim 11, wherein the dental gingival protector comprises a resilient, arched covering designed to substantially conform to the anatomy of the gingival ridge and having pre-configured incision holes of varying diameters for custom insertion of the dental gingival protector into an erupting tooth, such that the erupting tooth passes through the pre-configured incision holes, the dental gingival protector serving to provide a dry area. 14. The dental device of claim 12, wherein the dental gingival protector includes a treatment material layer on one or more surfaces, wherein the treatment material layer is adapted to neutralize the treatment material. 15. A dental device comprising: a. A deformable gingival seal used to cover the gums; b. A dental pad for forming a treatment cavity, the dental pad including a distal tooth sealing portion, the distal tooth sealing portion including at least one sealing plug, wherein the gingival sealing portion and the at least one distal tooth sealing portion define a gap between at least a portion of the device and a tooth on which the at least a portion rests; and c. At least one flow channel in fluid communication with the treatment cavity for allowing fluid to flow into or out of the treatment cavity; wherein the dental pad is placed in the patient's mouth on a plurality of teeth and/or gingival ridges, the gingival sealing portion contacts and deforms against the patient's gingiva to form a tight contact with the gingiva, the dental pad is combined with the gingival sealing portion, and the sealing plug of the distal tooth sealing portion deforms against a distal arrangement section of the dental arch to substantially define a seal at the distal tooth, thereby maintaining a vacuum within the treatment cavity and selectively allowing or preventing fluid from flowing into or out of the treatment cavity, while fluid can be introduced into the treatment cavity, removed from the treatment cavity, or introduced into and removed from the treatment cavity.