RU2794608C2 - Device and methods for collecting saliva samples from the oral cavity - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: group of inventions is intended for use at home when collecting saliva samples from the oral cavity for analysis. A device containing a mouthpiece is used, with the possibility of placing it in the oral cavity of a mammal. Moreover, the mouthpiece contains a chamber formed by the front and rear inner walls and the inner wall of the mouthpiece base. In this case, each of the front and rear inner walls of the chamber contains holes, as well as a switch located in the mouthpiece. The device further comprises a reservoir for collecting saliva, a reservoir for supplying fluid, a pump, and means for directing fluid through the said device. A switch located in the mouthpiece is actuated to pump saliva from the oral cavity into a saliva collection reservoir; deactivating the pumping of saliva into the saliva collection reservoir and then pumping fluid from the fluid supply reservoir into the mouthpiece for cleaning the oral cavity.

EFFECT: inventions allow to perform uniform collection of saliva for repeated analysis, while providing controlled collection of samples in the oral cavity.

13 cl, 7 dwg

Description

FIELD OF THE INVENTION

The present invention relates to devices and methods suitable for use in the home to collect samples of saliva from the oral cavity for analysis.

BACKGROUND OF THE INVENTION

Saliva analysis is a diagnostic technique that includes saliva analysis to detect markers of endocrine, immunological, inflammatory, infectious and other types of diseases. Saliva is a suitable body fluid for the analysis of steroid hormones such as cortisol, genetic material such as RNA, proteins such as enzymes and antibodies, and various other substances, including natural metabolites, including salivary nitrite, which is a biomarker for nitric oxide content. Saliva analysis is used to screen for or diagnose a variety of conditions and diseases, including Cushing's disease, anovulation, HIV, cancer, parasites, hypogonadism, and allergies.

Saliva benefits include ease of collection, safety, non-invasiveness, availability, and accuracy. In addition, since multiple samples can be easily obtained, saliva analysis is particularly suitable for performing chronological assessments that span hours, days, or weeks.

Collecting bulk samples of whole saliva has many advantages. Bulk sampling allows a sample to be tested for more than one biomarker. Passive salivation is one way to collect bulk samples of whole saliva, along with the use of stimulating saliva sample collection agents. However, passive salivation takes a long time, and the use of agents that stimulate saliva sampling can increase the likelihood of sample contamination.

Daily oral hygiene has proven to be an effective prophylactic against the onset, development and/or complications of periodontal disease, gingivitis and/or caries. Unfortunately, however, even people who are most serious about brushing and flossing their teeth are often unable to reach, release and remove food particles, plaque or biofilm deep in the gums or between the teeth. Most people go to the dentist twice a year for professional teeth cleaning and tartar removal.

For many years, products have been developed to facilitate cleaning teeth at home, but so far there has not been a single universal device that is easy to handle and is able to simultaneously clean all surfaces of the teeth and / or the gingival or subgingival area. For these purposes, a conventional toothbrush is widely used, although its use consumes a significant amount of energy to ensure effective cleaning, in addition, a conventional toothbrush cannot provide sufficient cleaning of surfaces in the interdental spaces. To clean interdental areas today, in addition to a toothbrush, you need to use dental floss, a toothpick, or some other additional device.

Electric toothbrushes are not enough to provide proper interdental cleaning. Known devices for cleaning areas of interdental spaces are sprinklers for the oral cavity. However, these devices use a single jet of liquid, which must be directed precisely to the interdental region in order to effectively remove residual organic matter. Thus, such water pump-based cleaning devices are generally only useful for cleaning braced teeth, in which large food particles are often lodged. It should be understood that at present, the removal of both organic matter and plaque requires the use of a combination of several devices, which is too time consuming and inconvenient.

In addition, for the effective use of these devices and cleaning methods, the user requires strict adherence to all procedures and / or instructions. Differences observed from user to user in the cleaning time used to clean or treat the composition, the cleaning procedure, etc. will inevitably affect the quality of the cleaning.

Thus, the collection and analysis of saliva is a safe, simple, non-invasive, affordable and accurate diagnostic technique for assessing the health status of a subject. Simple methods for collecting bulk samples of whole saliva have many advantages. In addition, devices and methods for collecting whole saliva and alleviating the pathological condition or improving the cosmetic condition of the oral cavity are needed.

SUMMARY OF THE INVENTION

In accordance with one aspect, methods are provided for collecting saliva from the oral cavity of a mammal, including: placing the mouthpiece of a device containing the mouthpiece in the oral cavity of a mammal, the mouthpiece comprising a chamber formed by the front and rear inner walls and the inner wall of the base of the mouthpiece, each of the front and the rear inner walls of the chamber contains many holes, as well as a switch located in the mouthpiece; and the device further comprises a saliva collection tank, a fluid supply tank, a pump, and means for directing fluid through said device;

activating a switch located in the mouthpiece to pump saliva from the oral cavity to a saliva collection reservoir;

deactivating the pumping of saliva into the saliva collection reservoir; And

then injecting the fluid from the fluid supply reservoir into the mouthpiece for cleaning or treating the oral cavity.

BRIEF DESCRIPTION OF GRAPHICS

FIG. 1 schematically depicts one embodiment of an apparatus that can be used in the present invention.

FIG. 2 schematically depicts an alternative embodiment of an apparatus that may be used in the present invention.

FIG. 3 is a front top perspective view of a first embodiment of a mouth guard that can be used in the present invention.

FIG. 4 is a rear perspective view from below of the embodiment of the mouthguard shown in FIG. 3.

FIG. 5 is a vertical sectional view of the mouthguard shown in FIG. 3.

FIG. 6 is a horizontal sectional view of the mouthguard shown in FIG. 3.

FIG. 7a is a front top perspective view of an embodiment of a system that can be used in the present invention.

FIG. 7b is a front top perspective view of the handle section of the system.

FIG. 7c is a front top perspective view of the fluid reservoir section of the system.

FIG. 7d shows an insertion of the area of the fluid reservoir shown in FIG. 7c.

FIG. 7e is a cross-sectional view of the handle section of the system.

FIG. 7f shows the insertion of the handle area shown in FIG. 7e.

FIG. 7g is a front top perspective view of the system shown in FIG. 7a with a fluid reservoir attached to the base station.

FIG. 7h shows an inset of the main station area shown in FIG. 7g.

FIG. 7i is a partial sectional view of the main station of the system shown in FIG. 7a.

FIG. 7g is a partial sectional view of the system shown in FIG. 7a with a fluid reservoir attached to the base station.

FIG. 7k is a partial sectional view of the system shown in FIG. 7a with fluid reservoir and handle attached to the base station; And

in FIG. 7l shows the insertion of the base station and handle area shown in FIG. 7k.

DETAILED DESCRIPTION OF THE INVENTION

The present invention relates to devices suitable for collecting saliva samples from the oral cavity of a mammal. The device includes a mouthguard or mouthpiece containing a chamber for fitting around the user's teeth and means for collecting saliva samples from the oral cavity. In certain embodiments, the mouthpiece is suitable for directing fluid to a plurality of oral surfaces. In such embodiments, the chamber holds fluid near a plurality of oral surfaces and the anterior and posterior inner walls include a plurality of openings. The mouthpiece includes a first distributor for accommodating the first part of the fluid and directing the first part into the chamber through the holes in the front inner wall, a second distributor for accommodating the second part of the fluid and directing the second part into the chamber through the holes in the rear inner wall, the first supply port the first part of the fluid to and from the first distributor, the second port for supplying the second part of the fluid to and from the second distributor. The mouthpiece further includes means for effectively securing the mouthpiece within the oral cavity. The invention further relates to methods for collecting and analyzing saliva samples from the oral cavity, including the steps of placing the device in the oral cavity, collecting saliva samples, and analyzing saliva samples.

The terms "reciprocating movement of the fluid(s) medium(s)" and "reciprocating movement of the fluid(s) medium(s)" are used interchangeably in this document. As used herein, both terms refer to changing the direction of flow of fluid(s) back and forth across the oral surfaces of a mammal from a first flow direction to a second flow direction opposite the first flow direction.

The term "effective fit or fastening" means that the degree of sealing between the means for directing fluid to a plurality of surfaces in and around the oral cavity, such as mouthguards, is such that the amount of leakage of fluid from the mouthguard into the mouth during use is small enough to reduce or minimize the amount of fluid used and maintain comfort for the user, such as avoiding choking or gagging. The gag reflex is, without limitation, a reflex (i.e., unintentional) contraction of the muscles of the posterior pharynx caused by stimulation of the posterior soft palate, pharyngeal wall, tonsil region, or root of the tongue, which is a protective movement that prevents foreign objects from entering the pharynx and Airways. Different people have differences in the gag reflex, such as which areas of the mouth stimulate it. In addition to the physical causes of the gag reflex, there may be a psychological component, for example, people who are afraid of choking can easily gag when something is placed in their mouth.

As used herein, the term "fluid delivery means" includes structures by which fluid can enter or be transported through systems and devices in accordance with the present invention, and includes, without limitation, passages, tubes, ports, portals, channels, gaps , pipes and distributors. Such fluid delivery means can be used in devices for providing reciprocating movement of fluids and means for directing fluids on and around oral surfaces. Such supply means also supply fluid to the guiding means and provide fluid to the reciprocating means from a reservoir to accommodate the fluid, the reservoir being contained within a portable device containing the reciprocating means, or generally block. The supply means also supplies fluid from the main unit to a fluid reservoir contained in the portable device.

The inventions described herein include methods and devices used to collect saliva samples from the oral cavity of a mammal, such as a human, for analysis and diagnosis. The devices of the invention not only collect saliva, but can also provide oral health benefits such as cleaning or dressing.

The use of the mouthpiece in accordance with the invention allows for sequential sampling over a larger area of the oral cavity to obtain a better and more homogeneous diagnostic saliva sample, as well as to ensure uniform sampling in specific areas of the oral cavity, as described in more detail below in this document. An advantage of the devices and methods of the invention is to obtain an in vivo saliva sample before, during or after sampling. In certain embodiments, saliva sample collection stimulating agents and/or thickening agents, which can provide a more uniform, higher quality saliva sample, may be administered before, during, or after saliva sample collection.

Certain methods involve collecting a saliva sample from the oral cavity for analysis and bringing a plurality of oral surfaces into contact with a fluid that is capable of effectively providing the desired oral health benefit. Such methods provide reciprocating movement of the fluid(s) medium(s) over a plurality of surfaces of the oral cavity under conditions capable of providing the desired beneficial effect for the oral cavity. Contact of multiple surfaces with the fluid may be carried out essentially simultaneously. The term "substantially simultaneously" means that while not all of the multiple surfaces of the oral cavity are necessarily in contact with saliva at the same time, most of the surfaces are in contact at the same time or within a short period of time, thereby providing an effect similar to that of contact of all surfaces at the same time. Collection of saliva samples can be carried out before, simultaneously with or after bringing the surfaces of the oral cavity into contact with the fluid. In certain embodiments, the implementation of the collection can be carried out before, at the same time and after bringing the surfaces of the oral cavity into contact with the fluid.

Conditions for providing the desired oral benefit may vary depending on the particular situation, circumstances and desired effect. The various variables are interrelated and provide a specific fluid velocity. In some embodiments, the requirements for fluid flow rate may be determined by the composition of the composition. For example, as the viscosity changes, the content of additives such as abrasives, viscosity reducers, etc., and the overall flow characteristics of the composition, the flow rate requirements of the jets may change to provide the same level of performance. Factors that may be considered to provide the proper conditions for achieving a particular desired beneficial effect include, without limitation, fluid flow rate and/or flow rate and/or pressure, fluid pulsation, fluid spray geometry or pattern, fluid temperature. environment and the frequency of the cycle of reciprocating movement of the fluid.

Fluid pressures, that is, the pressure in the distributor just before the exit of the jets, can be from about 0.5 psi. inch to about 30 psi. inch, or from about 3 psi. inch to about 15 psi. inch, or about 5 psi. inch. The fluid flow rate may be from about 10 ml/s to about 60 ml/s, or from about 20 ml/s to about 40 ml/s. It should be noted that the larger the jets and the higher their number, the greater the fluid flow rate at a given pressure/velocity. The pulse rate (related to pulse width and delivery (ml/pulse) may range from about 0.5 Hz to about 50 Hz, or from about 5 Hz to about 25 Hz. The duty cycle of the delivery pulses can be from about 10% to 100 % or from about 40% to about 60%.It should be noted that at 100% there are no pulses, but instead there is a continuous flow of fluid.The volume of the pulse of supply (total volume supplied through all jets/nozzles) can be in the range from about 0.2 ml to about 120 ml or from about 0.5 ml to about 15 ml The jet velocity per pulse can be from about 4 cm/s to about 400 cm/s or from about 20 cm/s to about 160 inches/ c. The duty cycle of the vacuum cycle can be from about 10% to 100%, or from about 50% to 100%. Note that the vacuum is constantly on and is 100%. The volumetric ratio of liquid supply to vacuum can be in the range of about 2: 1 to about 1:20 or from about 1:1 to 1:10.

Fluid(s) medium(s) may include at least one ingredient or agent capable of effectively providing the desired beneficial effect, in an amount sufficient to provide a beneficial effect in contact with oral surfaces. For example, the fluid may be a liquid, and the liquid may include, without limitation, an ingredient selected from the group consisting of a cleansing agent, an antimicrobial agent, a mineralizing agent, a desensitizing agent, a surfactant, and a whitening agent. In certain embodiments, more than one fluid may be used in a single session. For example, the oral cavity may be treated with a cleaning solution and then with a second solution containing, for example, a whitening agent or an antimicrobial agent. Solutions may also include multiple agents to provide more than one beneficial effect per application. For example, the solution may include both a cleansing agent and an oral soothing agent, as further described below. In addition, a single solution may effectively provide more than one oral benefit. For example, the solution may include a single agent that simultaneously cleanses the mouth and has an antimicrobial effect, or simultaneously cleanses the mouth and whitens the teeth.

Fluids used to improve cosmetic oral health may include a whitening agent to whiten teeth in the mouth. Such whitening agents may include, without limitation, hydrogen peroxide and carbamide peroxide or other agents capable of generating hydrogen peroxide when applied to teeth. Other bleaching agents may include abrasives such as silica, sodium bicarbonate, alumina, apatite, and bioglass.

It should be noted that although abrasives may serve to clean and/or whiten teeth, some abrasives may also help to reduce tooth hypersensitivity caused by enamel reduction and opening up to tubules in the teeth.

In some embodiments, the implementation of the liquid may contain an antimicrobial composition containing an alcohol having from 3 to 6 carbon atoms. The liquid may be an antimicrobial mouthrinse composition, in particular a reduced or substantially ethanol-free composition, providing a high level of efficacy against plaque, gum disease and bad breath. Said alcohols having from 3 to 6 carbon atoms are aliphatic alcohols. A particular aliphatic alcohol having 3 carbon atoms is 1-propanol.

In one embodiment, the liquid may contain an antimicrobial composition comprising (a) an antimicrobial effective amount of thymol and one or more other essential oils, (b) from about 0.01% to about 70.0% by volume, or from 0. 1% to about 30% vol., or from 0.1% to about 10% vol., or from 0.2% to about 8% vol. an alcohol having 3 to 6 carbon atoms; and (c) a carrier medium. The alcohol may be 1-propanol. The liquid carrier medium may be aqueous or non-aqueous and may include thickeners or thickeners to provide the compositions with a specific consistency. The preferred carrier medium is water and mixtures of water and ethanol.

In another embodiment, the liquid is an antimicrobial composition containing (a) having an antimicrobial effect, an effective amount of an antimicrobial agent, (b) from about 0.01% to about 70% vol., or from 0.1% to about 30% vol. , or from 0.2% to about 8% vol. propanol; and (c) a carrier medium. The antimicrobial composition of this embodiment has surprisingly higher delivery system kinetics compared to prior art ethanol systems. Examples of antimicrobial agents that can be used include, without limitation, essential oils, cetylpyridinium chloride (CPC), chlorhexidine, hexetidine, chitosan, triclosan, domiphen bromide, tin fluoride, soluble pyrophosphates, metal oxides, including, but not limited to, zinc oxide, peppermint oil, sage oil, sanguinaria, dicalcium dihydrate, aloe vera, polyols, protease, lipase, amylase, and metal salts including, but not limited to, zinc citrate, and the like. A particularly preferred aspect of this embodiment relates to an oral antimicrobial composition. applications, such as mouthwash, having about 30% vol. or less, or about 10% vol. or less, or about 3% vol. or less than 1-propanol.

In yet another embodiment, the liquid is a reduced ethanol antimicrobial mouthrinse composition that contains (a) an antimicrobial effective amount of thymol and one or more other essential oils; (b) from about 0.01 to about 30.0% vol., or from about 0.1 to about 10% vol., or from about 0.2 to about 8% vol. an alcohol having 3 to 6 carbon atoms; (c) ethanol in an amount of about 25% vol. or less; (d) at least one surfactant; and (e) water. Preferably, the total concentration of ethanol and alcohol having from 3 to 6 carbon atoms is not more than 30% vol., or not more than 25% vol., or not more than 22% vol.

In yet another embodiment, the liquid is an ethanol-free antimicrobial mouthrinse composition that contains (a) an antimicrobial effective amount of thymol and one or more other essential oils; (b) from about 0.01 to about 30.0% by volume, or from about 0.1 to about 10% by volume, or from about 0.2 to about 8% of an alcohol having from 3 to 6 carbon atoms; (c) at least one surfactant; and (d) water.

The alcohol having 3 to 6 carbon atoms is preferably selected from the group consisting of 1-propanol, 2-propanol, 1-butanol, 2-butanol, t-butanol and the corresponding diols. Preferred are 1-propanol and 2-propanol, and most preferred is 1-propanol.

In addition to generally improving oral hygiene by cleaning, such as removing or preventing the formation of plaque, food particles, biofilm, etc., the inventions can also be used to diagnose and alleviate oral pathological conditions and improve the cosmetic condition of the oral cavity. Pathological conditions may include, without limitation, caries, gingivitis, inflammation, symptoms associated with periodontal disease, bad breath, tooth sensitivity, and fungal infection. The liquids themselves may exist in a variety of forms, provided that their flow characteristics are compatible with use in the devices and methods of the present invention. For example, liquids may be selected from the group consisting of solutions, emulsions and dispersions. In some embodiments, the liquid may contain a suspended matter, such as an abrasive, dispersed in a liquid phase, such as an aqueous phase. In such cases, to treat oral surfaces, the abrasive must be substantially uniformly dispersed in the aqueous phase. In other embodiments, an oil-in-water or water-in-oil emulsion may be used. In such cases, the liquid will contain a discrete oil phase substantially uniformly dispersed throughout the continuous aqueous phase, or a discrete aqueous phase substantially uniformly dispersed throughout the continuous oil phase, depending on the type of emulsion. In other embodiments, the liquid may be a solution in which the agent is dissolved in the carrier medium, or in which the carrier medium itself may be considered an agent to provide the desired beneficial effect, such as alcohol or a mixture of alcohol and water, usually with other agents dissolved therein.

The present invention includes devices, such as an oral hygiene device, such as a dentifrice, suitable for use in the home and capable of collecting saliva samples from the oral cavity and directing the fluid to a plurality of tooth surfaces and/or gum areas. In some embodiments, the oral surfaces are brought into contact with the fluid substantially simultaneously. As used herein, reference to the gum area includes, without limitation, reference to the subgingival pocket. An appropriate fluid is directed to a plurality of tooth surfaces and/or gum area in a substantially simultaneous reciprocating manner under conditions capable of providing cleaning and/or overall improvement in the cosmetic condition of the oral cavity and/or alleviation of the pathological condition of the teeth and/or gum area, thus providing a substantially improved hygiene of the teeth and/or gums in the oral cavity. For example, one such device cleans the teeth and/or gum area and removes plaque using an appropriate cleansing fluid by delivering the fluid back and forth in a reciprocating manner to the anterior and posterior surfaces of the teeth and the surfaces of the teeth in the interdental spaces, thereby creating a cleaning cycle. while minimizing the amount of cleaning fluid used.

Devices of the invention that provide reciprocating movement of the fluid, contain means to control the reciprocating movement of the fluid. The control means includes means for supplying fluid to means for directing fluid to and from a plurality of oral cavity surfaces. In some embodiments, the means for providing reciprocating movement of the fluid include a plurality of portals for receiving and discharging the fluid, a plurality of passages or channels through which the fluid is supplied, and means for changing the direction of the fluid flow to provide reciprocating movement of the fluid , as described in more detail later in this document. Said controls may be controlled by a logic circuit and/or a mechanically controlled circuit.

In some embodiments, reciprocating devices may include means for attaching or attaching the device to a reservoir containing fluid. The reservoir may be detachably attached to the device. In this case, the reservoir and the device may contain means for connecting to each other. At the end of the procedure, the reservoir can be disposed of and replaced with another reservoir, or it can be refilled and reused. In other embodiments, the fluid reciprocating device will include an integral reservoir. In embodiments where a device can be connected to a base unit as described herein, a reservoir built into the device or releasably attached to the device can be refilled from a fluid reservoir included with the base unit. If there is a base unit, the device and the base unit will contain means for connecting to each other.

The device will contain a power source for actuating means for providing reciprocating movement of fluids. The power source may be located within the device, such as in the handle of the device, and may be, for example, batteries, rechargeable or disposable. If there is a base unit, said base unit may include means for providing power to the device. In other embodiments, the implementation of the main unit may include a means of charging the batteries located inside the device.

Fluid reciprocating devices will include means for connecting the device to means for directing fluid to a plurality of oral surfaces, such as a mouthguard or mouthpiece. In certain embodiments, the guiding means enables a plurality of oral cavity surfaces to be brought into contact with fluid substantially simultaneously. The connection means may provide a releasable attachment of the mouthpiece to the device. In such embodiments, a plurality of users may use their own mouthpiece with a single device containing reciprocating means. In other embodiments, the connection means may permanently attach the mouthpiece, thereby making the mouthpiece an integral part of the device. Reciprocating devices, as described above, may be contained within a housing, along with other device components, to form a portable device suitable for supplying fluid to the guiding means, as described herein below.

Means for directing fluid on the surface of the oral cavity, such as a mouthguard or mouthpiece, consist of many components. The guiding means comprises a fluid containment chamber near a plurality of surfaces, ie, a fluid contact chamber (LCC). The term "near" means that the fluid is in contact with the surfaces. The LCC is formed by a space defined by the anterior inner wall, the posterior inner wall of the mouthpiece, and a wall or membrane extending between and integral with the anterior and posterior inner walls of the mouthpiece, and in certain embodiments, the posterior gingival sealing membrane. The anterior and posterior inner walls, the wall between them, and the posterior gingival sealing membrane together form the fluid contact chamber membrane (LCCM). The LCCM has an overall U or n shape, depending on the position of the mouthpiece, that follows the contour of the teeth to provide a uniform and optimized liquid contact. LCCM can be flexible or rigid depending on the specific means for referral. The membrane can be placed as the main LCCM membrane. Each of the anterior and posterior interior walls of the LCCM includes a plurality of holes or slots through which fluid is directed to be brought into contact with a plurality of oral cavity surfaces.

The LCCM configuration can be optimized for maximum performance by varying the size, shape, thickness, materials used, volume created around the teeth/gingiva, nozzle configuration and placement in the mouth and relative to the teeth in combination with a distributor and gingival marginal seal for comfort and minimizing the risk of a gag reflex in the user. The combination of the above ensures effective contact of the teeth and gum area with the liquid.

The LCCM creates a controlled and isolated environment of known volume, i.e. LCC, to bring fluids into contact with the teeth and/or gum area and then remove waste fluids, as well as organic matter, plaque, etc., from the LCC, not allowing exposure of liquid, organic matter residues, etc. to the entire oral cavity. This reduces the chance of swallowing liquids. The LCCM also allows you to increase the flow and pressure of liquids without flooding individual nozzles, if, for example, significant flow rates are required for adequate cleaning. The LCCM also allows for reduced amounts of fluid and, if necessary, flow rates, since only the area within the LCC, rather than the entire oral cavity, is in contact with the fluid. The LCCM also allows control of fluid delivery to, through and around the teeth and gum region and the duration of fluid contact with the teeth and gum region, allowing fluid concentrations to be increased in the fluid contact area, thus providing more efficient fluid management and delivery.

The LCCM also allows for controlled oral sampling due to precise positioning of the mouthpiece in the oral cavity for detection or diagnostic applications. It may also enable visualization and/or diagnosis of gingival health in various ways. The system also provides the ability to expand functionality to clean and/or treat other areas of the oral cavity such as, but not limited to, the tongue, cheeks, gums, etc.

When used, saliva samples are collected from the oral cavity for diagnostic analysis. The benefits of guided oral sampling can include real-time analysis and feedback for the user, uniform sampling through the mouthpiece, and the ability to capture baseline conditions in the user's mouth and automatically analyze trends over time as part of a personalized analysis. The mouthpiece provides an excellent opportunity for uniform collection of saliva samples in the oral cavity. By "uniform collection" is meant that the collection of saliva, and therefore of saliva samples, is independent of compliance or methodology applied by the user. The mouthpiece may be fixed in the user's mouth in the same manner each time, with the saliva sample collection means placed in the same place each time the sample is collected. In addition, the collection environment can be consistent and manageable every time. In certain embodiments, the conditions and/or location of sampling can be confirmed by feedback from the sensor(s) installed in the mouthpiece.

The user may benefit from routine and regular tests to understand a personal baseline as many diagnostic tests vary from person to person. A user's baseline can be determined over time, allowing for a thorough and proper analysis through each use of the system.

Many useful diagnostic tests can be performed using oral saliva. While there are many ways to collect saliva in the art, professional training in the proper technique is often required to collect the correct amount of saliva required. Subsequently, the sample must be analyzed in a secondary method. The mouthpiece described herein allows a uniform collection of saliva for repetitive analysis.

The devices of the present invention are configured to initially collect fresh saliva before starting the cleaning/treatment process. This is achieved by placing a switch in or on the mouthpiece at a location sensitive to biting movement. In the process of application, the mouthpiece is first inserted into the mouth. The user bites down on the mouthpiece, activating the switch and starting the collection of saliva from the mouth.

In some embodiments, the user rebites the mouthpiece with a chewing motion. Chewing is known to stimulate the production of saliva in the mouth, thus causing more fresh saliva to be produced. After a predetermined number of bites, the collection of saliva is stopped and the cleaning/treatment process is started. The number of bites on the mouthpiece to switch the device from saliva collection to cleaning/processing is two or more, or three or more, or six or more, or eight or more, or ten or more.

In other embodiments, upon biting the mouthpiece for the first time, the user activates the collection of saliva from the oral cavity and also activates the timer. The user repeatedly bites on the mouthpiece with a chewing motion, stimulating the production of saliva in the oral cavity. After a predetermined time, the collection of saliva is stopped and the cleaning/treatment process is started. The time to switch the device from saliva collection to cleaning/processing is greater than about two seconds, or greater than about five seconds, or greater than about ten seconds, or greater than about fifteen seconds.

Each time you insert the mouthpiece into your mouth, it is in the same position. A plurality of nozzles are located throughout the mouth to collect saliva samples. During operation of the system, cleaning/treatment fluid may move through the device, into the oral cavity, and out of the oral cavity. As saliva moves through the mouth, it may mix with the fluid and therefore move through the system. The mixed solution can be analyzed in the device during its operation or stored for later analysis. If necessary, several agents can be used to increase saliva production and increase the percentage of saliva in the entire saliva mixture in the system. Methods include, without limitation, application of saliva-inducing saliva during operation of the system, exposing the user to specific salivation-inducing odors, electrical stimulation, ultrasonic stimulation, or mechanical stimulation.

In an alternative embodiment, the saliva mixture may be collected through a separate and/or dedicated distributor in the mouthpiece. By any means of collection, saliva may be collected before, during, or after the cleaning/treatment process, or any combination thereof.

The mouthpiece may also have collection means that contact the tongue to suck or absorb saliva from it. A tongue contact probe or plate may have one or more nozzles that create a vacuum on the tongue to collect saliva. In an alternative embodiment, the plate may absorb saliva and automatically extract saliva when performing a secondary method, or otherwise analyze saliva directly on the plate. As with the techniques described above, this method does not require the user to follow specific techniques.

Saliva samples can be used as diagnostic samples for a number of oral diseases and analyzed in a variety of diagnostic ways.

The device can diagnose caries risk through microfluidic immunoassays performed on saliva samples to detect S. mutans specific protein antigens and/or

bacteria Lactobacillus , with fluorescent detection of the output product. The analysis can be performed weekly or monthly and an alert can be sent to the user that bacteria levels have exceeded a high caries risk threshold. Alternatively, the device can measure the buffering capacity of saliva using a variety of absorbent plates with built-in pH indicators, as is known to those skilled in the art. A user alert may be triggered if the result is a low buffer capacity, indicating a high risk of caries. As an additional alternative, the device can directly measure the concentration of fluoride ions in saliva using a special fluorine ion electrode. A baseline can be established by monitoring the concentration of fluoride ions daily or weekly for a set period of time. Any significant deviations from the original concentration ranges may trigger a user alert.

The device can use microfluidic immunoassays to analyze saliva samples for antigens specific to bacteria associated with gingivitis and periodontitis. Analysis can be performed daily, weekly or monthly, with data logging over time. Any unwanted deviations from the normal trends will alert the user to see a dentist for further investigation.

Alternatively, the device can analyze saliva samples using an immunochromatographic assay (LFT). After collection, the sample can be mixed with a bacterial cell lysing agent and the resulting mixture applied to an immunochromatographic device in the main station that can detect antigens specific for S. mutans to assess the risk of carriage, as is known in the art. The immunochromatographic device can also detect antigens specific to bacteria associated with gingivitis and/or periodontitis alone or in combination with S. mutans antigens. It can also react with thiols in volatile sulfur compounds (VSCs) or detect antigens specific to VSC-producing bacteria to produce a detectable color change whose intensity correlates with the concentration of VSCs present. Immunochromatographic analysis can be performed in the main station with refillable LFT strips, either specific for a single disease, or strips that detect a combination of antigens and/or chemicals to detect multiple diseases of the oral cavity. The results can be evaluated at the main station. Alternatively, the test can be performed externally, whereby the user applies the sample collected and prepared by the device to the LFT strip, and the test results are visually read by the user based on the appearance of the color indicator or color change on the strip. Conversely, strip analysis can be performed automatically by digital image analysis.

Alternatively, the device may analyze saliva samples to determine the prevalence of disease-associated bacteria within the entire population in the sample using quantitative polymerase chain reaction (qPCR) analysis. The analysis may be performed within the device or base station using microfluidic techniques, or alternatively the sample may be collected and stored within the device and sent to an external laboratory for analysis. The analysis can be performed daily, weekly, or monthly, and a high number of S. mutans or Lactobacilli may alert the user that they may be at risk of caries, while a high number of periodontitis-associated organisms will alert the user to the possible prevalence of gum disease. . In each case, analysis can be performed daily, weekly, or monthly and monitored over time for significant deviations from normal trends.

Alternatively, the device may analyze saliva samples using DNA-DNA hybridization techniques to profile the sample's bacterial population. This information can be recorded daily, weekly or monthly and tracked over time to monitor changes in the relative amounts of various bacteria in the entire population. Significant adverse population biases trigger a warning to the user of an increased risk of disease onset or progression (eg, high risk of caries or periodontal disease). This information can also be used to track the progress of disease treatment.

In each of these cases, the user will most likely not perform or be unable to perform the diagnostic assays described, and most of these are not typically performed in dental offices. The mouthpiece may provide the added benefit of consistently receiving this information on a regular basis and may allow the user to closely monitor their oral health and take any necessary corrective action in a timely manner.

The sampling methods and diagnostic assays described above may be used in combination with each other in any combination. Due to the flexibility of the system, each sample should be collected only under certain conditions or by presetting, and not during each application. For example, some samples may need to be taken only once a week, while others may ideally be taken one or more times a day. The system can automatically adjust the sampling plan as needed for each subject based on results and predefined criteria.

In addition to the oral health diagnostics described above, the device can also additionally be used to diagnose general health and biomarkers related to general health, including, but not limited to, cancers, hypertension, diabetes, and the like.

Combinations of different biomarkers and samples can be used to perform more reliable analysis and diagnosis of specific diseases and obtain improved results, such as using GCG and saliva samples and/or testing for multiple disease-specific biomarkers. The presence of one biomarker can also automatically trigger sampling and analysis of other biomarkers to improve diagnostic results.

The diagnostic results may also be used to provide automated treatment for a disease and/or direct the user to purchase a specific product to prevent a potential disease. The treatment can also be customized by adding appropriate additives to the cleansing formulation for a particular user, depending on the result of the diagnosis. For example, adding an antibacterial, mouth odor reducing agent, desensitizing agent, bleach, fluoride, and/or any combination of these and/or other additives to treat oral disease and/or a general condition.

LCCM wall thicknesses can range from 0.2 mm to 1.5 mm to provide the required physical properties while minimizing material content and optimizing performance. The distance between the inner walls of the LCCM to the teeth can be from about 0.1 mm to about 5 mm, more typically the average distance is about 2.5 mm, to maximize comfort and minimize LCC customization and volume requirements.

In terms of mouthpiece size and shape, three standard universal sizes (small, medium, and large) are preferably used for both upper and lower teeth, but the configuration provides mechanisms for varying levels of customization for a particular user to provide comfort and functionality for a particular user. . The described device may have a locking mechanism that allows it to function only when properly installed in the oral cavity. The mouthpiece may include both upper and lower sections to provide substantially simultaneous contact of multiple surfaces of the oral cavity with the fluid. In an alternative embodiment, the upper and lower sections can be cleaned with a single bridge that can be used on the user's upper or lower teeth and gums (first installed on one cleaning part, then sequentially installed on the other cleaning part).

The number and location of openings located within the inner walls of the mouthpiece, also referred to herein as slits, atomizers or nozzles, through which the fluid is directed, will vary and be determined depending on the circumstances and environment of use, the particular user and the desired beneficial effect. The orifices may be circular, elliptical, trapezoidal, or any other geometry that provides effective contact of the oral surfaces with the fluid. The location and number of holes can be configured to direct the fluid jets to create different spray patterns effective to provide the desired benefit. The aperture diameter may range from about 0.1 mm to about 3 mm, or from about 0.2 mm to about 0.8 mm, or about 0.5 mm to provide effective cleaning and moderate blast rates and surface coverage.

Optimal opening location and direction/angles achieve coverage of substantially the entire surface of the teeth in the area when the oral cavity is brought into contact with fluid, including, but not limited to, interdental surfaces, upper, lateral and posterior surfaces of the teeth, and gingival pocket surfaces. In alternative embodiments, the orifices may have different sizes and different shapes to provide different cleaning modes, surface coverage and spray geometry to adjust the speeds, density and spatial shape of the spray jet (full cone, fan, partial cone, directional jet) or to account for the composition. The nozzles can also be tubular and/or protrude beyond the LCCM to provide a targeted spray or to spray in a sprinkler mode for wide coverage of the surface of the teeth, similar to hose spray systems. The nozzles are preferably integral with the inner walls of the LCCM and can be incorporated into the inner walls by any of the assembly or molding methods known in the art (compression molded inserts, mechanically machined membrane inserts, injection molded inserts, and etc.).

The LCCM can be made from an elastomeric material such as ethylene vinyl acetate (EVA), thermoplastic elastomer (TPE) or silicone to allow the inner walls to move and increase the swept area with minimal mechanical elements, thereby reducing volumetric flow requirements for optimum performance. and at the same time increasing the softness and flexibility of the tooth protection material in the event of direct contact with the teeth. The flexible membrane also allows for an acceptable device fit for a large number of users due to its ability to conform to the shape of the teeth. Alternatively, the LCCM may be made from a rigid or semi-rigid material such as, but not limited to, a thermoplastic.

It may be desirable, although not essential, for the LCCM to be able to move relative to the teeth. Moving the LCCM and subsequently guiding the nozzle during a cleaning and/or treatment operation provides improved coverage of the teeth/gingiva while minimizing the number of nozzles/fluid jets required to provide such coverage for cleaning and/or treatment. It also reduces the overall fluid flow requirement required, which reduces the overall fluid requirement and overall device costs associated with providing adequate flow, resulting in a smaller, lighter and more practical device. This movement also allows the device to provide a more versatile fit for the user (the same size LCCM can be used for different users) while still compensating for slight misalignment/position of the LCCM relative to the user's teeth/gums.

In some embodiments, the LCCM is moved by pressurization, pulsation, and fluid movement through the distributors. In alternative embodiments, the implementation of this movement can be provided by vibration, sonic or ultrasonic mechanism. Such movement may also be provided by a separate network of tubes and/or distributors constructed within or attached to the LCC that can contain or release fluid and/or air to create the necessary movement of the membrane. In addition, movement of the LCCM may result from movement of the user's jaw or teeth. In an alternative embodiment, the LCCM movement system may also include mechanical movement of the LCCM by means of a directional reciprocating motion as in a guide groove, the guide groove being created by teeth. In another alternative embodiment, the desired movement of the LCCM may be generated by using one or multiple linear motor systems that provide sequential movement through a plurality of permanent magnet/coil pairs placed at strategic positions on the mouthpiece to optimize cleaning and treatment sequences for directing jets and cleaning agents. elements. In yet another alternative embodiment, the movement can be created by means of shape memory materials or piezoelectrics.

In a preferred embodiment, the system provides pulsation of various elements, including through the distributor, delivery channels and nozzles, vacuum distributors, pump channels and nozzles, and through reciprocating/changing flow direction, when the delivery channels become pump channels, and the pump channels - delivery channels. Fluid pulsation results in fluctuations in fluid pressure within the described elements, creating the required movement of the LCCM as described. The LCCM is capable of operating with fluid pulsation means provided to create the necessary movement and movement/direction of the nozzles in the X, Y and Z directions through the combination of materials and configuration of the LCCM, while still providing the necessary performance required to minimize leakage. into the oral cavity without compromising the structural integrity of the mouthpiece, including the LCCM.

Movement/pulsation of elements can be consistent or unordered. The ripple can be provided at a fixed frequency, multiple frequencies, and/or out of phase for individual elements to create the required movement. There is no need for all elements to pulse at the same time. For example, in some cases it may be necessary to pulse only the delivery elements, while the vacuum does not pulse.

In addition, the LCCM may include cleaning elements and/or spacers that will move relative to the LCCM to have any effect on the teeth and/or gums. These cleaning elements and/or spacers may also be used to restrict movement of the LCCM if necessary to maintain a minimum distance between the LCCM and the teeth and/or gums during movement and placement of the device by the user. This provides a minimum distance between the nozzle placed inside the LCCM and the surface to be treated and cleaned, preventing nozzle blockage and preventing fluid delivery and/or removal. When moving the separator during cleaning and/or processing during the LCCM movement, the separator does not interfere with cleaning and/or processing of surfaces in direct contact with the separator, since the interaction site on the surface is constantly changing. In addition, movement of the spacer relative to the surface to be cleaned/treated may have the additional benefit of cleaning and/or stimulating the contact surface during the cleaning/treatment process in a manner similar to brushing the teeth or massaging the gums.

In an alternative embodiment, the LCCM may also include abrasive elements such as fibers, textures, polishing elements, additives (silicon oxide, etc.) and other geometries that can be used to meet other cavity cleaning/treatment requirements. mouth, as well as to ensure a minimum distance between the teeth and LCCM to perform, without limitation, processing and cleaning of teeth and positioning.

In some embodiments, the LCCM may include a measurement means that determines the correct position of the mouthpiece over the teeth in the oral cavity and which does not allow the device to be actuated unless this position is confirmed by the sensor. Also, if the mouthpiece moves or moves out of this position during use, it will immediately stop working. A lock switch can be included in the mouthguard cleaning process.

Means of measurement may be manual, as in a manual switch(es) such as a membrane switch or other switches known in the art. You can also use other contact and non-contact measuring instruments, such as ultrasonic, magnetic (Hall sensors), frequency, pneumatic, capacitive, inductive, laser, optical and other measuring instruments and devices known in this field.

The measuring device must be located in the device in such a way that it measures the change or generates a signal when the user places the mouthpiece in an acceptable position in the mouth and allows the device to perform the appropriate cycle.

An alternative and potentially redundant means of determining the correct position and orientation of the mouthpiece is to monitor the current and/or power required by the drive(s) motor(s). If the current exceeds the allowable range, this indicates that the mouthpiece may be incorrectly positioned, blocking either the delivery of fluid or the removal/evacuation of fluid from the LCCM. If this current is too low, it indicates that there is no restriction on pumping or delivery flow and may also indicate that the mouthpiece is not in the correct position in the user's mouth, for example if the user accidentally removed the device before completing a cleaning/treatment cycle or started a cycle with an incorrect location in the oral cavity.

The LCCM can be formed in a variety of ways, including, without limitation, machining, injection molding, blow molding, extrusion molding, compression molding, and/or vacuum molding. It can also be formed with the valve but with the valve circuitry inside the LCC, and/or pressed onto the valve for a single design with minimal assembly requirements.

In one embodiment, the LCCM can be manufactured separately and then assembled into a single structure with distributors using any number of assembly and sealing techniques, including the use of adhesives, epoxies, silicones, heat sealing, ultrasonic welding, and hot melt adhesives. The LCCM is designed in such a way that, when assembled with a distributor, it effectively results in the preferred two-valve configuration without the use of any additional components.

In certain embodiments, LCCM may also be performed or used to create a region of gingival compaction. In certain embodiments, a vacuum is created within the LCC to improve the fit of the mouthpiece in the oral cavity to form a gum-tight seal. In other embodiments, the oral cavity is pressurized outside the LCCM to improve the fit of the mouthpiece in the oral cavity to form a gingival seal. In other embodiments, on first use, an adhesive such as denture adhesive may be applied around the perimeter of the mouthpiece to provide a customized, reusable, resilient seal when inserted into a particular user's mouth. Subsequently, the adhesive becomes resiliently fixed to simultaneously follow the shape of the gums and provide an effective seal, also during subsequent uses. In another embodiment, the sealant can be applied and/or replaced or disposed of after each use.

The guiding means also includes a first distributor for accommodating liquid and for supplying liquid to the LCC through openings in the front inner wall and a second distributor for accommodating liquid and for supplying liquid to the chamber through openings in the rear inner wall. Such a configuration provides for a number of different options depending on the type of procedure being performed. For example, during a cleaning procedure, it may be preferable to deliver fluid jets in the LCC directly onto the teeth on one side of the LCC through the first distributor and then pump/pull the fluid around the teeth on the other side of the LCC into the second distributor to provide controlled cleaning of interdental spaces, margins and surfaces. gums This flow on one side of the LCC can be repeated several times with a pulsating action until the direction of the flow is reversed to deliver liquid jets back from the second distributor and pump/pull liquid through the back of the teeth into the first distributor for a period of time and/or number of cycles. This action of the fluid creates a turbulent, repetitive and reversible flow, thus allowing the fluid to reciprocate around the oral surfaces.

In treatment, pre-treatment or post-treatment, it may be preferable to deliver liquid through one or both distributors simultaneously, fill the chamber and coat the teeth with liquid for a period of time, and subsequently empty the chamber through one or both distributors after a predetermined period of time.

In alternative embodiments, the dispenser may be configured as a single dispenser to push and pull fluid through the same jets at the same time, or may have any number of dispenser compartments to provide even greater control over fluid delivery and removal for cleaning and fluid handling. When using a multi-distributor design, liquid-only and only-removal distributors may also be used. The distributors can also be integral with and/or within the LCCM.

The material for the dispenser may be a semi-rigid thermoplastic that can provide sufficient rigidity to resist compression or rupture from controlled flow of fluids, yet provide some flexibility in fitting within the user's mouth for insertion, sealing/positioning and removal of the mouthpiece. To simplify the manufacturing process, minimize the number of components and the cost of processing, the double distributor is assembled with LCCM. The distributor may also be multi-component to provide a softer tactile feel for the teeth/gums using lower stiffness elastomeric materials such as, but not limited to, compatible thermoplastic elastomer (TPE). The distributor can be formed in various ways, including, without limitation, machining, injection molding, blow molding, extrusion molding, compression molding, or vacuum molding.

As shown, the guiding means also includes a first port for conveying fluid to and from the first distributor and a second port for conveying fluid to and from the second distributor, as well as means for providing effective sealing of the guiding means within the oral cavity, i.e. gum seals. In some embodiments, the first and second ports may serve both to transfer fluid to and from the first and second distributors and to attach the mouthpiece to the mouthpiece fluid delivery means. In other embodiments, the guiding means may further include means for attaching the guiding means to the means for supplying fluid to the guiding means.

FIG. 1 schematically depicts an embodiment of a method and system in accordance with the present invention. The system is configured to initially collect fresh saliva before starting the cleaning/treatment process. The figure shows a system 10' , the components of which include: a reservoir 12 for collecting saliva, a reservoir 14 for supplying fluid, means for directing fluid to a plurality of surfaces of the oral cavity, in this case representing a tray or mouthpiece 16 , a pump 18' , valves 22 and 24 flow control and tubes 31 , 33 and 35 to move the fluid through the system. A switch 20 is located in or on the mouthpiece 16 to initiate a saliva collection and cleaning/processing cycle. The tubes 35 are inserted into the tube 33 .

The pump 18 may be a piston pump, a valveless rotary piston pump, a diaphragm pump, a peristaltic pump, a gear pump, a rotary pump, a double-acting piston pump, a vane pump, or the like. The fluid reservoir 14 may be made of glass, plastic or metal. The fluid supply reservoir 14 may be integral with the system 10 and may be refillable. In some embodiments, the fluid reservoir 14 may be a replaceable fluid reservoir, such as a disposable or reusable cassette, detachably coupled to the system 10' .

In some embodiments, the fluid reservoir 14 and/or the tubes 31 , 33 , and 35 may include a heat source to preheat the fluid before being directed to the mouthpiece 16 for use on oral surfaces. The temperature of the liquid must be maintained within a range that provides efficiency and user comfort during application.

Mouth 16″ , described in more detail hereinafter, may be integral or detachably attached to system 10 using tubes 31″ , 33 and additional attachments (not shown). It can be single-sided or double-sided and has internal, easy-to-clean filters to capture food particles. When placed within the oral cavity, such as around the teeth and gums, the mouthpiece 16 forms a secure fit or snug against the gums and includes means for directing fluid to oral surfaces, such as tooth surfaces.

During the saliva collection process, the saliva collected in the mouthpiece 16 flows through the tube 33 , the pump 18 and the flow valve 22 into the saliva collection reservoir 12 . During the cleaning/treatment cycle, the fluid contained in the fluid reservoir 14 flows through the tube 35' , the flow control valve 24 , enters the tube 31 and flows through the pump 18 into the mouthpiece 16' .

In some embodiments, during the cleaning/treatment cycle, the fluid from the mouthpiece 16 is returned to the fluid reservoir 14 by flowing through the tube 31' . This allows the system 10 to use a smaller volume of fluid for processing/cleaning.

In other embodiments, the system10 It has means for ensuring the reciprocating movement of the fluid medium between the tank14 for fluid supply and mouthpiece16. In this embodiment, during the cleaning/treatment cycle, the fluid contained in the reservoir14 for supplying fluid, flows through the tube35, valve24 flow control, enters the tube31 and flows through the pump18 into the mouthpiece16 and returns to the tank14 to supply a fluid flowing through a tube31. Subsequently, the flow direction is reversed and the fluid contained in the reservoir14 for supplying fluid, flows through the tube31 into the mouthpiece16 and returns to the tank14 to supply a fluid flowing through a tube31, pump18, valve24 flow control and tube35. In some embodiments, the direction of flow is reversed by reversing the flow direction of the pump18e.g. when using a gear pump.

The saliva collection and cleaning/treatment actions of system 10 may be controlled by a logic circuit that may include a program to start saliva collection when switch 20 is activated via a biting movement, and after saliva collection is completed, start a cleaning/treatment cycle. In embodiments that use cleaning/treatment fluid reciprocation, the program performs a reciprocation cycle to reciprocate the fluid around the teeth, thereby providing oral health benefits such as cleaning teeth. Finally, the system 10 has a program to empty the mouthpiece 16 at the end of the reciprocating cycle and a self-cleaning cycle to clean the system between uses or at predetermined automatic cleaning times.

The system 10 may also include a front panel with indicator lights, not shown in the figure. Indicators may include, without limitation, indicators for power on, full, reciprocating program in progress, system empty, cleaning result or feedback, and self-cleaning cycle in progress. In embodiments in which the fluid is preheated before being directed into the cap 16 , a backlight can also be used to indicate that the fluid is at the proper temperature for use.

One method of using the system 10 to collect saliva and clean/treat teeth involves several steps. In the first stage, the user places the tray 16 in the mouth around the teeth and gum area. The user fits the mouth guard 16 tightly, thus providing a proper fit or seal between the gums, teeth and mouth guard 16 . When using the system in accordance with the invention, the user bites on the mouthpiece, activating a switch in the mouthpiece to start the system. The whole method is implemented as follows:

1. The system 10 is activated when the user bites on the mouthpiece 16 , activating the switch 20 to start saliva collection from the mouth. The flow control valve 24 is closed and the flow control valve 22 is open. The pump 18 starts to take the saliva collected in the cap 16 through the tube 33 , the pump 18 and the flow control valve 22 , while the saliva is collected in the saliva collection tank 12 .

2. After the saliva collection is completed, the system10 actuated to start supplying cleaning/treatment fluid to the mouthpiece16. Valve22 flow control is closed and the valve24 flow control is open. Pump18 begins to draw cleaning/treatment fluid from the reservoir14 for supplying fluid through a tube35 through the valve24 flow control, handset33 And pump18. In the cap16 supply fluid for cleaning/processing.

3. Cleaning/processing is continued until the required time has elapsed.

In an alternative use of the saliva collection and cleaning/treatment system 10 , in which the cleaning/treatment fluid is reciprocated through the system 10' , the user places the tray 16 in the mouth around the teeth and gum area. The user fits the mouth guard 16 tightly, thus providing a proper fit or seal between the gums, teeth and mouth guard 16 . The user bites on the mouthpiece, activating a switch in the mouthpiece to start the system. The whole method is implemented as follows:

1. The system 10 is activated when the user bites on the mouthpiece 16 , activating the switch 20 to start saliva collection from the mouth. The flow control valve 24 is closed and the flow control valve 22 is open. The pump 18 starts to take the saliva collected in the cap 16 through the tube 33 , the pump 18 and the flow control valve 22 , while the saliva is collected in the saliva collection tank 12 .

2. After the saliva collection is completed, the system10 actuated to start supplying cleaning/treatment fluid to the mouthpiece16. Valve22 flow control is closed and the valve24 flow control is open. Pump18 begins to draw cleaning/treatment fluid from the reservoir14 for supplying fluid through a tube35 through the valve24 flow control, handset33 And pump18. In the cap16 supply fluid for cleaning/processing. Subsequently, cleaning/treatment fluid is drawn out of the cap16 through the tube31 and collected in a tank14 for fluid supply.

3. To reciprocate the cleaning fluid, the fluid flow direction is reversed by reversing the flow direction in the pump 18' . The flow control valve 22 remains closed and the flow control valve 24 remains open. Pump 18 begins to pump cleaning/treatment fluid from cap 16 through tube 33 through pump 18 , tube 35 , and flow control valve 24 into fluid reservoir 14 . Subsequently, the cleaning/treatment fluid is drawn in through the tube 31 and supplied to the cap 16 by the pump 18 , thus completing one reciprocating cycle.

4. Steps 2 and 3 are repeated (with flow reversed) for each reciprocating cycle.

5. Step 4 is repeated until the predetermined cleaning/processing time has elapsed or until the required number of reciprocating cycles has been completed.

It should be noted that there may be a delay between steps 2 and 3 (either or both directions) to allow for processing time during which the fluid can be in contact with the teeth without flow.

FIG. 2 schematically depicts an alternative embodiment of a system and method in accordance with the present invention. The system is configured to initially collect fresh saliva before starting the cleaning/treatment process. The figure shows a system 50' , the components of which include: a reservoir 52 for collecting saliva, reservoirs 54 and 55 for supplying fluid, means for directing fluid to a plurality of surfaces of the oral cavity, in this case representing a tray or mouthpiece 56' , pumps 58 and 59 , a flow control valve 62 and tubes 71 , 73 , 75 and 77 to move fluid through the system. A switch 60 is located in or on the mouthpiece 56 to initiate a saliva collection and cleaning/processing cycle.

Pumps 58 and 59 may be piston pumps, valveless rotary piston pumps, diaphragm pumps, peristaltic pumps, gear pumps , rotary pumps, double-acting piston pumps, vane pumps, or the like. glass, plastic or metal. The fluid reservoirs 54 and 55 may be integral with the system 50 and may be refillable. In some embodiments, the fluid reservoirs 54 and 55 may be replaceable fluid reservoirs 54 and 55 , such as disposable or reusable cassettes, detachably coupled to the system 50' .

In some embodiments, the fluid reservoirs 54 and 55 and/or tubing 71' , 73 ', 75 and 77 may include a heat source to preheat the fluid before being directed to the mouthpiece 56 for use on oral surfaces. The temperature of the liquid must be maintained within a range that provides efficiency and user comfort during application.

Mouth 56″ , described in more detail hereinafter, may be integral or detachably attached to system 50 with tubes 71″ , 73 and additional attachments (not shown). It can be single-sided or double-sided and has internal, easy-to-clean filters to capture food particles. When placed within the oral cavity, such as around the teeth and gums, the mouthpiece 56 forms a secure fit or snug against the gums and includes means for directing fluid to oral surfaces, such as tooth surfaces.

During the saliva collection process, the saliva collected in the mouthpiece 56 flows through the tube 73 , the pump 58 and the flow valve 62 into the saliva collection reservoir 52 . During the cleaning/treatment cycle, the fluid contained in the fluid supply tanks 54 and 55 flows through the tubes 71 and 75 into the mouthpiece 56' . Pump 59 is used to pump cleaning/processing fluid into mouthpiece 56' .

In this embodiment, during the cleaning/treatment cycle, the fluid from the mouthpiece 56 may return to the fluid reservoirs 54 and 55 by flowing through the tubes 71 and 75' . This allows the system 50 to use small volumes of cleaning/treatment fluid. The volumes of cleaning/treatment fluid used by the system 50 may be less than about 40 ml, or less than about 30 ml, or less than about 20 ml, or less than about 10 ml.

In one embodiment, pump 59 draws fluid contained in fluid reservoir 54 through tube 77 , pump 59 , and into fluid reservoir 55 . Subsequently, the liquid contained in the fluid reservoir 55 is forcibly conveyed through the tube 75 to the mouthpiece 56' . The fluid contained in the mouthpiece 56 is forcibly conveyed through the tube 71 into the fluid reservoir 54 . The cleaning/treatment fluid continues to circulate through the fluid reservoir 54 , the fluid reservoir 55 , and the mouthpiece 56' .

In another embodiment, pump 59 draws fluid contained in fluid reservoir 55 through tube 77 , pump 59 , and into fluid reservoir 54 . Subsequently, the fluid contained in the fluid reservoir 54 is forcibly moved through the tube 1 into the mouthpiece 56 . The fluid contained in the mouthpiece 56 is forcibly conveyed through the tube 75 into the fluid reservoir 55 . The cleaning/treatment fluid continues to circulate through the fluid reservoir 55 , the fluid reservoir 54 and the mouthpiece 56 .

In another embodiment, the system50 It has means for ensuring the reciprocating movement of the fluid between the tanks54 And55 for fluid supply and mouthpiece56. During the cleaning/treatment cycle, the pump59 can first be installed on the intake of the fluid contained in the tank54 for fluid supply, through a tube77, pump59 and into the tank55 for fluid supply. Subsequently, the fluid contained in the reservoir55 for supplying fluid, forcibly moved through the tube75 into the mouthpiece56. Fluid contained in the mouthpiece56, forced to move through the tube71 into the tank54 for fluid supply. Subsequently, the flow direction is reversed and the pump59 can first be installed on the intake of the fluid contained in the tank55 for fluid supply, through a tube77, pump59 and into the reservoir54 for fluid supply. Subsequently, the fluid contained in the reservoir54 for supplying fluid, forcibly moved through the tube71 into the mouthpiece56. Fluid contained in the mouthpiece56, forced to move through the tube75 into the tank55 for fluid supply. In some embodiments, the direction of flow is reversed by reversing the flow direction of the pump59e.g. when using a gear pump.

The saliva collection and cleaning/treatment actions of system 50 may be controlled by a logic circuit that may include a program to start saliva collection when switch 60 is activated via a biting movement, and after saliva collection is completed, start a cleaning/treatment cycle. In embodiments that use cleaning/treatment fluid reciprocation, the program performs a reciprocation cycle to reciprocate the fluid around the teeth, thereby providing oral health benefits such as cleaning teeth. Finally, the system 50 has a program to empty the mouthpiece 56 at the end of the reciprocating cycle and a self-cleaning cycle to clean the system between uses or at predetermined automatic cleaning times.

As mentioned in the descriptions of the embodiments depicted in FIG. 1, a front panel with indicator lights can also be integrated into the system 50 . Indicators may include, without limitation, indicators for power on, full, reciprocating program in progress, system empty, cleaning result or feedback, and self-cleaning cycle in progress. In embodiments where the fluid is preheated prior to being directed to the cap 56 , a backlight may also be applied to indicate that the fluid is at the proper temperature for use.

One method of using the system 50 to collect saliva and clean/treat teeth involves several steps. In the first stage, the user places the tray 56 in the mouth around the teeth and gum area. The user fits the mouthguard 56 tightly, thus providing a proper fit or seal between the gums, teeth and mouthguard 56 . When using the system in accordance with the invention, the user bites on the mouthpiece, activating a switch in the mouthpiece to start the system. The whole method is implemented as follows:

1. The system 50 is activated when the user bites on the mouthpiece 56 , activating the switch 60 to start saliva collection from the mouth. The flow control valve 62 opens. The pump 58 begins to draw the saliva collected in the cap 56 through the tube 73 , the pump 58 and the flow control valve 62 , while the saliva is collected in the saliva collection reservoir 52 .

2. After saliva collection is complete, the system 50 is activated to begin supplying cleaning/treatment fluid to the mouth guard 56' . The flow control valve 62 is closed. Pump 59 draws fluid contained in fluid reservoir 54 through tube 77 , pump 59, and into fluid reservoir 55 , forcibly moving fluid from fluid reservoir 55 through tube 75 to mouthpiece 56 . The fluid contained in the mouthpiece 56 is forcibly conveyed through the tube 71 into the fluid reservoir 54 .

3. Cleaning/processing is continued until the required time has elapsed.

Naturally, if the pump59 configured to draw fluid from the tank55 for fluid supply, described higher the stages are similar, except for the direction of flow from the tanks54 And55 for fluid supply and mouthpiece56.

In an alternative method of using the saliva collection and cleaning/treatment system 50 , in which cleaning/treatment fluid is reciprocated through the system 50' , the user places the tray 56 in the mouth around the teeth and gum area. The user fits the mouthguard 56 tightly, thus providing a proper fit or seal between the gums, teeth and mouthguard 56 . The user bites on the mouthpiece, activating a switch in the mouthpiece to start the system. The whole method is implemented as follows:

1. The system 50 is activated when the user bites on the mouthpiece 56 , activating the switch 60 to start saliva collection from the mouth. The flow control valve 62 opens. The pump 58 begins to draw the saliva collected in the cap 56 through the tube 73 , the pump 58 and the flow control valve 62 , while the saliva is collected in the saliva collection reservoir 52 .

2. After saliva collection is complete, the system 50 is activated to begin supplying cleaning/treatment fluid to the mouth guard 56' . The flow control valve 62 is closed. Pump 59 draws fluid contained in fluid reservoir 54 through tube 77 , pump 59, and into fluid reservoir 55 , forcibly moving fluid from fluid reservoir 55 through tube 75 to mouthpiece 56 . The fluid contained in the mouthpiece 56 is forcibly conveyed through the tube 71 into the fluid reservoir 54 .

3. To reciprocate the cleaning fluid, the fluid flow direction is reversed by reversing the flow direction in the pump 59 . The flow control valve 22 remains closed. Pump 59 draws fluid contained in fluid reservoir 55 through tube 77 , pump 59, and into fluid reservoir 54 , forcibly moving fluid from fluid reservoir 54 through tube 71 to mouthpiece 56 . The fluid contained in the mouthpiece 56 is forcibly moved through the tube 75 into the fluid reservoir 55 , thus completing one cycle of reciprocation.

4. Steps 2 and 3 are repeated (with flow reversed) for each reciprocating cycle.

5. Step 4 is repeated until the predetermined cleaning/processing time has elapsed or until the required number of reciprocating cycles has been completed.

It should be noted that there may be a delay between steps 2 and 3 (either or both directions) to allow for processing time during which the fluid can be in contact with the teeth without flow.

FIG. 3 is a top perspective view of a first embodiment of means for directing a fluid or liquid to a plurality of surfaces in the oral cavity, such as trays 100″ , in accordance with the present invention. FIG. 4 is a bottom perspective view of the cap 100 of FIG. 3. The figures show a mouthguard 100 with an outer anterior wall 112' , an outer posterior wall 114' , an inner anterior wall 116' , an inner posterior wall 118' , and a base membrane such as a bite plate 156' . The inner front wall jet outlets 132 are located on the inner front wall 116 , and the inner rear wall jet outlets 134 are located on the inner rear wall 118 . Shown in FIG. 3 and 4, the inner front wall jet outlets 132 and the inner rear wall jet outlets 134 are just one embodiment of the jet outlets. The first port 142 and the second port 144 enter the mouthpiece 100 through the outer front wall 112 .

FIG. 3 and 4 depict an embodiment of a mouthguard 100 in which the wearer's upper and lower teeth and/or gum region are substantially simultaneously in contact with the liquid to achieve the desired benefit. It should be understood that, in other embodiments, the tray 100 may be configured to clean and/or treat only the upper or lower teeth and/or gum area of the wearer.

FIG. 5 and 6 show vertical and horizontal sectional views, respectively, of the mouth guard 100 of FIG. 3. The figures show the first distributor 146' , defined as the space defined by the outer front wall 112 and the inner front wall 116' . The second distributor 148 is defined as the space defined by the outer back wall 114 and the inner back wall 118 . The liquid contact chamber (LCC) 154 is formed by an inner front wall 116 , an inner rear wall 118 , and a base membrane 156 .

In one embodiment, fluid enters the first distributor 146 through the first port 142 under pressure and subsequently enters the LCC 154 through the inner front wall jet slits 132 . A vacuum is created in the second port 144 to draw liquid through the slits 134 to jet the inner back wall into the second distributor 148 and finally into the second port 144' . In this embodiment, the liquid jets are first directed to the anterior surfaces of the teeth and/or gum areas on one side of the LCC 154 , pass through, between and around the surfaces of the teeth and/or gum area on the other side of the LCC 154 , and enter the second distributor to provide controlled cleaning. or treatment of interdental spaces, edges and surfaces of the gum area. The flow direction in the distributors is then reversed. Pressurized cleaning fluid enters the second distributor 148 through the second port 144 and subsequently into the LCC 154 through the inner back wall jet slits 134 . A vacuum is created in the first port 142 to draw liquid through the slots 132 to blast the inner front wall into the first distributor 146 and finally into the first port 142' . In the second part of this embodiment, the liquid jets are directed to the posterior surfaces of the teeth and/or gingiva and pass through, between and around the surfaces of the teeth and/or gingiva. The alternate application of pressure and vacuum over several cycles creates a turbulent, repetitive and reversible flow, reciprocating the fluid around a plurality of oral surfaces to substantially simultaneously bring the oral surfaces into contact with the fluid, thus providing the desired beneficial effect.

In another embodiment, it may be preferable to deliver liquid through one or both distributors at the same time, fill the LCC 154 and coat the teeth with liquid for a period of time, and then empty the LCC 154 through one or both distributors after a predetermined period of time. In this case, the cleaning and treatment liquid is simultaneously supplied under pressure to the first distributor 146 through the first port 142 and to the second distributor 148 through the second port 144 , and subsequently to the LCC 154 simultaneously through the slots 132 for discharging the jet of the inner front wall and the slot 134 for discharging jets of the inner rear wall. To empty the LCC 154, a vacuum is simultaneously created in the first distributor 146 through the first port 142 and in the second distributor 148 through the second port 144 . The cleaning or treatment liquid is sucked through the inner front wall jet outlet 132 and the inner back wall jet outlet 134 into the first distributor 146 and into the second distributor 148' .

It is also possible to deliver different liquid compositions to the first distributor 146 and to the second distributor 148 . Various liquid compositions may subsequently be mixed into the LCC to enhance cleaning performance or processing effects.

Sealing on the gums

The gum seal forms the lower portion of the LCCM and contacts the gum tissue in such a way as to clean the gum area, including the subgingival pocket. In one embodiment, it provides positioning of the mouthpiece in relation to the mouth and teeth and creates a relatively isolated environment with minimal/tolerable leakage during operation, while being designed to minimize the risk of a gag reflex and provide comfort to the user. In one embodiment, the gingival seal is created by frictional engagement and compression of the elastomeric material with the gingiva. This seal is strengthened during the pumping of the liquid inside and during cleaning and processing cycles. The seal also functions as an auxiliary mechanism for attaching and assembling the distributor to the LCCM. With respect to the size and shape of the gingival seal, three standard universal sizes (small, medium and large) are preferably used, but they are designed to provide various levels of customization for a particular user for comfort and cleaning/treatment efficiency. These dimensions are related to the three basic dimensions of the valve and LCCM components.

Alternative embodiments for creating a gingival seal include the following and may be used in combination with each other or with the above embodiment.

Embodiment #1

The mouthpiece is located inside the mouth and on the gum. The seal and position is fixed against the teeth and gums by applying slight biting pressure to the supports/mounting blocks. The mouthpiece is made of a single material or a combination of materials of varying hardness and resilience. In a preferred embodiment, the H-shaped mouthpiece has flexible walls (vertical "H" edges) with soft, resilient cushioning material (closed-cell silicone, gel-filled seal, etc.) at the ends of each "H" leg. The horizontal "H" plate includes bite blocks/supports for setting the mouthpiece in X, Y and/or Z positions relative to the teeth and gums. Once the mouthpiece has been placed in the oral cavity, the occlusion of the maxilla and mandibles to interact with the bite blocks ensures that the mouthpiece is securely and rigidly positioned in relation to the oral cavity, while ensuring that the liner material interacts with the gingival material to ensure effective sealing and formation of a cavity for cleaning, processing and / or diagnostics during the entire duration of work.

Embodiment #2

The force applied to the mouthpiece to move the sidewalls inward seals the soft elastic edge against the gum tissue. A mouthpiece similar to the one described in Embodiment #1 also provides an active locking feature to improve sealing. One possible implementation of this requires a hollow section formed within the horizontal stem and between some or all of the supports between the top and bottom sections of the mouthpiece when the device is not in the engaged state. After placing the mouthpiece in the mouth, the user bites and squeezes the hollow section, which is subsequently compressed so that all bite blocks are in contact. This, in turn, causes the outer walls (portions of the vertical legs) to wrap inward against the gum tissue. An elastic pad attached to these walls engages and presses against the gum, creating a seal and a cleaning, diagnosis and/or treatment chamber surrounding the upper and lower teeth.

Embodiment #3

After installing the mouthpiece in the oral cavity to create a seal on the gums and the cavity, the pneumatic elastic balloon is inflated or pressurized in it. A mouthpiece similar to that described in Embodiment #1 can also provide an active seal by inflating the bladder or bladders within the mouthpiece. Subsequently, the air can also be used to clean and/or dry the teeth/cavity and/or treat (with gas and/or entrained particles in the gas) for treatment, cleaning and/or diagnosis.

Embodiment #4

After installing the mouthpiece in the oral cavity to create a seal on the gums and cavity, the hydraulic elastic balloon is inflated or pressurized in it. A mouthpiece similar to that described in Embodiment #1 can also provide an active seal by pressurizing the bladder(s) within the mouthpiece. Subsequently, the liquid composition can also be used to clean and/or treat teeth and/or gum tissue with or without gas or entrained particles for cleaning, treatment or diagnosis.

Embodiment #5

Once the mouthpiece is positioned in the mouth, a seal is created by changing the plasticity of the material in contact with the gum, with or without expansion of the material to create a seal around the gums through fluid absorption (use of hydrogel, etc.).

Embodiment #6

Once the mouthpiece is placed in the mouth, nitanol wire or other shape-memory materials embedded in the mouthpiece cause the sidewalls to adhere to the gum due to changes in body temperature in the mouth, creating a secure seal with the gum tissue.

Embodiment No. 10

The foam material is first or alternatively during each use extruded into the mouthpiece area to create a seal on the mouthpiece and subsequently clean, treat and diagnose the cavity.

Embodiment No. 11

A disposable or dissolvable insert is provided to ensure a snug fit to the gum tissue with multiple or each use of the mouthpiece.

Embodiment No. 12

The contact surface of the gum seal contains an adhesive that can react with saliva or water. The adhesive provides a potential improvement in sealing and may be designed for single or multiple use, depending on formulation. The sealing system may be used with any combination of the other sealing systems described.

Embodiment No. 13

The gingival seal is created by a combination of material at the contact area and geometric structure at the interface, which creates a suction-like effect in the contact area of the seal (suction cup) by creating a vacuum in this area during bonding.

Embodiment No. 14

The gingival seal area can be fabricated and adapted to the user's mouth with a deformable material that can be placed and positioned relative to the gum, after which it assumes a permanent shape for the user. This can be achieved by boiling and placing in the mouth and pressing against the gum by occlusion of the jaw and/or a similar method, followed by removal from the oral cavity (similar to a dental tray). As the seal material cools, it assumes a permanent shape.

Embodiment No. 15

A gingival seal area can be created by taking a standard or semi-standard bladder and placing it in the oral cavity in close proximity to the desired gingival seal contact area. Subsequently, this elastic balloon can be filled and directionally supported so that it interacts and follows the shape of the gum. The fill material is a fast curing material that must be able to provide a custom seal shape that can then be reused by that particular user. The balloon can be made of TPE and/or silicone-based thin material, and the fill material can be a room temperature cure (RTV), epoxy, polyurethane, or similar material to provide a rigid, semi-rigid, or flexible permanent shape at hardening or curing.

In a preferred embodiment, the effective gingival seal is a contact seal created by the geometry of the lower edge of the LCCM in contact with the gingiva. The lower edge of the LCCM is preferably flexible to conform to the various gingival surfaces of the user below the gingival margin and along the points of contact. This area should also be soft enough not to cause abrasion or damage to the gum area to provide comfort to the wearer while maintaining an effective seal. In the preferred geometry, the contact area of the LCCM provides a radial and/or curved smooth surface to provide a point of contact and a comfortable seal. The preferred material for this edge is low durometer silicone (less than 100 Ra, and more preferably 15 Ra to 70 Ra) due to its durability and initial characteristics, but it can also be a soft and/or flexible material such as TPE and other materials known in the art.

An effective seal is formed in combination with the operation of the vacuum and the removal of saliva from the LCC, which allows the residual liquid from the universal device to be drawn back into the LCC and portable device for subsequent disposal.

Components

As a whole, the system will be essentially modular, so that the subject can easily replace individual components. Reasons for replacement include, without limitation, wear, malfunction, and biohazard. Some components may also be disposable and substantially replaceable (refillable cartridges, etc.), thus being modular and easily replaceable by the user.

Pumping system

In one embodiment, liquid may be supplied from the reservoir to the mouthpiece handle or main station by means of a powered pump. The pump may be capable of responding to a logic system (artificial intelligence or AI) input for changes in pressure, cycle time (for each stage and process as a whole), reciprocation and/or time requirements, flow direction, fluid velocity/pressure , scavenging characteristics, and the like. The pumps may be piston pumps, valveless rotary piston pumps, diaphragm pumps, peristaltic pumps, gear pumps, rotary pumps, double-acting piston pumps, vane pumps, etc. In an alternative embodiment, the system is also can drive a charged pneumatic cylinder or an air compressor. The cycle time for the entire process, the cycle time for each individual stage, and the flow rate for each individual stage of the cycle may vary and can potentially be tailored to each individual user/day of the week/oral condition. It is also possible to vary the amount of fluid delivered per stroke or over a period of time in various system offerings, depending on the needs of a particular user and particular processing requirements. The pumping system can be located in the handle or in the main station. The volume of liquid may be relatively large to provide the effect of pulsing the liquid in the mouthpiece. In an alternative embodiment, the pump delivers a constant flow with little or no pulsation. The direction of fluid into and out of the mouthpiece can be reversed by reversing the direction of rotation of a motor in a valveless rotary pump, gear pump, or other means. The fluid propulsion system will not start until the mouthpiece is properly inserted and firmly pressed against the gums. The system will automatically stop the supply and removal of residual liquid from the mouth after removing the mouthpiece (violation of the tightness of the seal along the gums) from the mouth. This will allow the user to safely increase the concentrations of the active ingredients in the cleaning/treatment formulation. The system will not start until the mouthpiece is sealed against the gums. In one embodiment, the pumping system is located entirely in the handle, while in another it is located in the main station.

Valve/fluid control and fluid in/out

When using an embodiment of the mouthpiece in which the mouthpiece has one inlet and one outlet, it may be desirable to change the direction of the flow entering the mouthpiece. The direction of fluid flow through the teeth is reversed by reversing the direction of the inlet and outlet flows to the mouthpiece, thereby increasing the efficiency and sensory effects of the cleaning process. The mouthpiece may have nozzles on opposite sides of the teeth, in which jets are supplied under pressure on one side, and a negative pressure difference is created on the opposite side. This results in the forced movement of fluid through/between the teeth. Subsequently, in each group of nozzles, the flow is reversed to move the fluid through the teeth in the opposite direction. Subsequently, the fluid can reciprocate forward and backward. The flow direction can be reversed and/or reciprocated by changing the direction of a special pump such as a gear pump or a valveless rotary pump. Another embodiment includes, but is not limited to, reversible check valves, wherein the position of the check valves relative to the pump is reversed, resulting in a reversal of flow in the system. Another embodiment includes two 3-way control valves with a logic (AI) system that reverses flow when actuated. An additional embodiment has a logic (AI) system for a single 4-way control valve with one pump inlet, pump return, and two mouthpiece outlets that can reverse flow if required. Another embodiment includes arranging the tubes to block flow to particular tubes with check valves to reverse the flow of the system. Another embodiment involves developing a fluid control junction box that connects two tubes on one side of the box to two tubes on the opposite side of the box. In one position, the flow of liquid moves directly through the box from one lying on one straight tube to another, and in the other position, the flow of liquid moves in the X direction, while the directions of the flow of liquid intersect in the junction box. In another embodiment, the reciprocating flow is by a double acting piston pump, with the flow constantly moving back and forth between the two heads of the piston pump.

In one embodiment, the fluid management system is located entirely in the handle, and in another embodiment, the fluid management system is housed in the main station. The tubing used in the system must be able to withstand both pressure and vacuum.

One or more types of liquid may be delivered from separate reservoirs through the mouthpiece, either individually or in combination. Any combination and concentration can be used. The reservoirs can be in the handle or in the main station.

The system may include manual and/or automatic air purge and/or an accumulator to ensure system compressibility.

The valve system for directing and controlling fluid to and from the vacuum and pump delivery systems can be optimized to provide a modular, low cost, and efficient system that allows for ease of manufacture and assembly. In addition, improved system maintenance can be achieved by using a cut sheet of flexible film sandwiched between two injection moldable components.

The switching/reciprocating fluid control system for generating fluid reciprocating motion can be mechanical (mechanism/gear driven) or electrical (electrically operated valve, such as multi-way flow control solenoid valves activated by an electrical signal). ). In the preferred mechanical embodiment, the switching system is driven by the pump drive motor(s) to minimize the size, complexity and cost of the overall system. This is done through mechanical links and gearing, as shown below, which actuates a unique shifting mechanism. The switching mechanism may be essentially reciprocating, such as a cam engaging a sliding switching element, pushing it back and forth. It can also be a unique, continuous rotating switching disc element, as shown in the exploded views and cross section below, switching fluid direction 2 times per revolution of the disc due to the unique D-shaped flow path. The configuration provides a built-in function element similar to a pressure relief valve that allows flows to cross when switching flow directions without any additional hardware to minimize drive motor/system stress and increase motor/system life.

Interface (electrical and fluid)

The handle may have an electrical system and/or a communication system that communicates with the base station. This includes, without limitation, battery charging, transfer of diagnostic information between units, transfer of user profile information between units, and transfer of program information between units. Information can be transmitted wirelessly (RFID, 802.11, infrared, etc.) or via a hardwired connection. The electrical system will include a logic circuit to control the operation, start and stop of the system based on predetermined criteria. Such criteria may include starting only after creating a seal between the mouthpiece and the gums, ensuring that the system is properly filled with liquid, ensuring that the battery has a minimum level of charge, ensuring that the liquid level is within a given range, etc. There may be a logic system that can communicate with various device components, including, but not limited to, triggering algorithms for controlling valve sequence, piston movement and therefore fluid movement, receiving consumer inputs, receiving temperature sensor inputs, receiving diagnostic input, detecting mouthpiece seal engagement with gums, etc. e. The logic system must be capable of processing and responding to the input signal and outputting the corresponding data. The system may include redundant circuitry that provides a fail-safe configuration.

The system may include means to provide feedback to the user such as lights, a display, a touch screen, recorded messages, vibration, sounds, smell, etc. It may also have means to control the system and select processes/settings, such as switches, touch screens, buttons, voice commands, etc.

The system may include means to track statistics such as time between applications, duration of application/cycle, total number of applications, regimen details (amount and time for each fluid/treatment), time to change specific system components, etc. System may provide feedback to the user to indicate the timing of replacement or replenishment, wear of disposable or replacement components.

There is a liquid supply method, which may be a liquid reservoir, a hose system, or the like. The supply liquid can be placed in the main station and pumped into the reservoir in the handle while the handle is in the main station. Subsequently, liquid may be delivered through the mouthpiece during the cleaning process and removed from the system after delivery and/or after the cleaning process. In another embodiment, the handle is connected to the main station by fluid supply means and liquid is delivered from the reservoir to the main station through the handle directly to the mouthpiece.

There may be disposable cassettes that may contain processing solutions, cleaning solutions, diagnostic solutions, and the like. The cassettes may be modularly configured so that they can be easily changed by the user.

The system may include means for detecting the level of plaque on the teeth. One such detection method is to apply a solution of fluorescein, which has been proven to adhere to plaque, to the teeth and monitor the light waves emitted from the fluorescein-coated plaque versus uncoated areas of the teeth. The light waves are different for each area, so you can determine which areas and how much plaque is present on the teeth. Other similar methods for detecting plaque can also be used, such as visual systems.

Cleaning/Flushing/Refilling

The fluid system can be filled with disposable cassettes by filling the chamber, accessing the main tank in the main station using a tube or other means of transferring fluid (gravimetric method, hand pump, siphon pump, use of the main pump drive or an auxiliary system to fill / fill tanks and so on.). Fluid tanks can be filled with a combination of different fluids to create a unique combination of different fluid concentrations. In another embodiment, the ingredients may initially be in a non-liquid form (gel, powder, tablet, etc.) and may be combined with a liquid to provide additional handling and/or purification benefits.

The handle will have a simple and easily activated purge control by the user during and/or after the cleaning process. This can be achieved in such a way as pressing a single button by the user, which will cause liquid and debris to be blown out of the handle. In another embodiment, excess liquid and waste flows from the handle into a waste reservoir or drain system outside or inside the main station. A filtration system may be present to protect components from contamination. In a further embodiment, the handle accommodates a disposable waste cassette. In an alternative embodiment, the mouthpiece is cleaned in the main station between uses. The cleaning method includes, without limitation, UV cleaning, alcohol bath immersion, alternating cleaning liquid bath immersion, or other similar method. The cleaning liquid bath may or may not circulate in and/or around the mouthpiece.

Drive system

The fluid system may be driven by a rotary motor with means to convert the movement from rotational to linear. This can be achieved using an eccentric cam, linear sliders, or other known methods. In an alternative embodiment, the system may be driven by a linear motor or multiple linear motors. This will possibly reduce the size of the fluid system and provide additional control over fluid delivery by pumping the fluid with vacuum. The engine(s) can (may) directly move the pistons up and down in translation.

To optimize configuration and minimize device size, linear drive components can be integrated into the pumping system. A magnet may be incorporated into the piston itself, and the helix may be inserted into or around the outer walls of the piston chamber. Alternatively, the piston and/or fixed means of attachment to the piston may be a movable part, and the magnet may be stationary (i.e., surround or be within the walls of the piston). In addition, both the vacuum and pressure pistons may have built-in magnets that oppose each other, providing or assisting in the movement of the piston.

The motor will also drive the movement of the reciprocating fluid controller. The rotary motor may have a worm, bevel or similar gear assembly for converting motor rotation into rotation of the reciprocating fluid controller. The outer circumference of the reciprocating fluid controller may be formed by teeth of a gear wheel, which can be used as means for rotating the disc of the reciprocating fluid controller when converting motor rotation. Alternatively, the linear motor may drive the frequency division (FDM) system by means of a ratchet or gear mechanism, such as a Maltese type motion conversion.

In some embodiments, the delivery and vacuum sections may be in line with each other. Alternatively, they may be oriented parallel to each other. Each position has different advantages in terms of compactness. The delivery and vacuum sections may be coupled together or alternatively operate independently, may be synchronized in frequency and/or some frequency factor (i.e. the vacuum section may have the delivery section volumetric capacity but move at a different speed) or may operate asynchronously. If the delivery and vacuum sections are in line with each other, they can be connected via a rod. This allows the pressure and vacuum pistons to move at the same time, providing synchronization between the pressure and vacuum strokes.

The pressure piston may be driven by the same rod that drives the vacuum piston, but may also have some means of cushioning and/or delaying one relative to the other, such as a slot in which it attaches to the piston. This may provide additional free play for the pressure piston, whereby the vacuum stroke starts shortly before the pressure stroke and continues for a short time after the pressure stroke. This may provide an additional opportunity to remove liquid from the device during the vacuum stroke, since it still creates a vacuum and the discharge piston remains stationary, as well as minimize leakage due to gravity and the position of the device in the oral cavity.

The vacuum piston and pressure piston may be provided with a means of dumping liquid into the reservoir to ensure safety in case of partial or complete blockage, which can lead to premature failure of the device components (motors, valves, seals, etc.). This ensures safe and controlled operation and prevents overpressure in the event of failure of the main flow ports and ensures reproducible operation of the device in terms of efficiency. Discharge to a local reservoir rather than to atmosphere minimizes the possibility of fluid leakage outside the device.

Temperature control

In one embodiment, the temperature of the liquid can be controlled within a predetermined range. If the liquid is too cold, it can cause discomfort and discomfort in the user's mouth. If the liquid temperature is too high, it may cause discomfort, discomfort, and damage to the user's mouth. The system can be configured to not start if the fluid temperature exceeds a set limit. If the temperature is below the set minimum limit, the heating element can increase it. The system can be set to not start unless the fluid temperature is within the set range. Temperature feedback may be provided, without limitation, by thermistors, thermocouples, IR, or other temperature control devices. This information can be fed back to the logic (AI) system.

The drive system may have means to heat the fluid to a predetermined temperature range. The fluid may be heated at one or more positions in the system. Liquid heating methods include, but are not limited to, an inductive element, a radiant element, a ceramic element, a tubular heating element (e.g., a thin coil of chromium-nickel wire in an insulating binder (MgO, alumina powder) sealed inside a stainless steel or brass tube), silicone heater, mica heater or infrared heater.

On FIG. 7a -7l show an exemplary embodiment of the dental cleaning system 2000 of the present invention. The figures show a 2000 dental cleaning system having a handle 2220 , a base station 2250 , and a base station fluid reservoir 2280 . The base station fluid reservoir 2280 is used to replenish the fluid reservoirs in the handle 2220 . Cap 2100 shown attached to handle 2220 .

In this embodiment, the base station fill tube 2245 is the passage through which cleaning and processing fluid flows from the base station fluid reservoir 2280 to the fluid reservoirs in the handle 2220 . Liquid exits the main station liquid reservoir 2280 through the main station liquid reservoir port 2285 and enters the liquid reservoirs in the handle 2220 through the handle port 2225 .

While in the 2250 main station, the 2220 handle's internal battery is recharged and the 2220 handle fluid reservoirs are replenished from the 2250 main station's reservoirs. Any diagnostic information contained in the 2220 handle will be transmitted to the 2250 main station. The handle 2220 may also be subjected to a cleaning process.

FIG. 7A is a front top perspective view of an embodiment of a dental cleaning system 2000' including a handle 2220' , a main station 2250 , and a main station fluid reservoir 2280 . The base station 2250 includes a base station cover 2252 , a sanitizing chamber 2254 , a UV emitter 2256 for decontamination, a UV emitter switch 2206 , a start button 2262 , indicator lights 2264 , and a power cord with an AC adapter 2270 . To sanitize the mouth guard 2100 between uses, the 2254 chamber uses the 2256 UV emitter for decontamination. The UV emitter switch 2206 disables the UV emitter 2256 for decontamination when the cover 2252 of the main station is opened or not tightly closed. The UV emitter switch can also be used to start the sanitizing process when the lid is closed and the handle is inserted into the main station. The indicator lights 2264 can be used to inform the user of the state of charge, the position or sanitization status of the handle 2220 , or the status of the main station fluid reservoir 2280 (eg, full/empty).

The handle 2220 includes an attached mouth guard 2100 shown in FIG. 7b, and handle port 2225 . Fluid enters and exits handle 2220 through handle port 2225 .

FIG. 7c is a front top perspective view of the base station liquid tank 2280 . As shown in the base station fluid reservoir insert 2280 (FIG. 7d), the base station fluid reservoir 2280 includes a base station fluid reservoir port 2285 from which fresh fluid is used to fill the handle 2220 , and a reservoir lock member 2282 for base station fluid used to interface the base station fluid reservoir 2280 with the base station 2250 . The main station liquid reservoir port 2285 includes a ring 2287 to provide a seal between the reservoir port 2285 and the main station inlet tube 2245 a .

A partial sectional view of the handle 2220 is shown in FIG. 7e. As shown in the handle insert 2220 (FIG. 7f, the handle port 2225 includes a handle port 2225 from which fresh fluid is used to fill the handle 2220 . The handle port 2225 includes a ball bearing 2222 and a spring assembly 2224 . into the handle 2220 through the handle port 2225 , passes through the ball bearing 2222 and the spring assembly 2224 which acts as a means of sealing the handle 2220 when it is not engaged with the main station.

FIG. 7g with insert FIG. 7h shows a docking element 2232 for connecting the main station and the handle. The liquid from the port 2230 of the main station passes through the docking element 2232 before entering the port 2225 of the handle. The ring 2234 provides a seal between the base station port 2230 and the handle port 2225 . A switch/sensor may also be placed in the docking area for the handle of the main station 2250 to ensure that the handle 2220 is in the proper docking position to load liquid from the main station 2250 and/or start the mouthguard sanitization process. The portable position/docking status can also be checked using feedback from the main station with a portable charging circuit.

FIG. 7i shows a partial sectional view of the base station 2250 without the handle 2220 or base station fluid reservoir 2280 attached. Partial sectional view showing pump 2247 , heating coil 2249 , tubing 2245 a from tank to pump, tubing 2245 b from main station pump to main station port, and microcontroller and circuit board 2241 and handle charging plate 2243 located on the main station 2250 .

FIG. 7j shows a partial sectional view of the base station 2250 with the base station fluid reservoir 2280 attached. The base station fluid reservoir blocking member 2282 is used to engage the base station fluid reservoir 2280 with the base station 2250 . When engaged, the fluid in the base station fluid reservoir 2280 may pass through the base station reservoir tube 2282 , exiting the base station fluid reservoir 2280 through the reservoir port 2285 , and entering the base station 2250 through the base station inlet tube 2245a . The heating coil 2249 is used to heat the fluids in the tubes 2245 a and 2245 b before the fluid enters the handle 2220 .

FIG. 7k shows a partial sectional view of the base station 2250 with the handle 2220 attached and the base station fluid reservoir 2280 . As shown in the inset (FIG. 7l), when handle 2220 is attached to base station 2250 , docking member 2232 contacts ball bearing 2222 and spring assembly 2224 , displacing ball bearing 2222 and allowing fluid to fill handle 2220 .

In this embodiment, the main station liquid reservoir 2280 will be placed in the main station 2250 containing sufficient liquid so that the reservoir 2280 can be used several times before it is empty. The removable and replaceable reservoir 2280 will cooperate with the main station 2250 through the fluid reservoir blocking member 2282 to both properly position and hold the reservoir 2280 in the main station 2250 , as well as provide a seal for fluid to pass into the main station 2250 .

Fluid is pumped from the base station fluid reservoir 2280 passing through the heating coil 2249 where it is heated to an acceptable temperature to minimize the annoyance of the LCC when it is used in the cleaning/processing process.

The handle 2220 is placed by the user in the handle dock in the main station 2250 . The handle 2220 engages with the main station 2250 using docking features both to properly position and hold the handle 2220 in the correct position on the main station 2250 to allow fluid from the main station fluid reservoir 2280 to be pumped into a local reservoir in the handle 2220 . The handle 2220 includes an element that opens to allow fluid flow from the main station 2250 when properly positioned in the docking station. When the handle 2220 is removed from the base station 2250, the fluid passage is automatically closed and sealed.

Thus, the main station 2250 accommodates a fluid loading system handle, a fluid heating system, a UV mouthpiece sanitization chamber, a portable charging station, an electronic control device, and a signal conditioning system to control all aspects of fluid loading, heating, and mouthpiece sanitization, as well as providing a docking station for the handle 2220 and the disposable reservoir 2280 . The main station 2250 may also include a user interface to provide feedback to the user about system status and diagnostic analysis results, such as, but not limited to, fluid level, charge level, sanitizing process status, device last used time.

In other embodiments, a positive displacement pump with check valves will be used to deliver the liquid.

In still other embodiments, a rotary piston pump will be used to deliver the fluid. This pump is known to those skilled in the art, in which the piston rotates as it reciprocates, so valves are not required for operation. Reversing the direction of rotation of the drive motor will reverse the direction of fluid flow.

In still other embodiments, diaphragm pumps, gear pumps, or double acting piston pumps will be used to deliver fluid. In the case of using double-acting piston pumps with a filled liquid system, this type of pump has an advantage, as it provides a reciprocating movement of the liquid flow to the mouthpiece. Charged pneumatic cylinders, a hand pump, or rotary pumps can be used to propel the system.

Claims (24)

1. Method for collecting saliva from the oral cavity of a mammal, including: placement of the mouthpiece of the device containing the specified mouthpiece in the oral cavity of a mammal, and the specified mouthpiece contains a chamber formed by the front and rear inner walls and the main inner wall of the specified mouthpiece, while the specified main wall passes between the specified front and rear inner walls, each of the specified the front and rear inner walls of the specified chamber contains many holes and a switch located in the specified mouthpiece in a place susceptible to biting movement, and the specified switch is activated by biting it; and wherein said device further comprises a saliva collection tank, a fluid supply tank, a pump, and means for directing fluid through said device; activating said switch located in said mouthpiece by biting said switch to pump saliva from the oral cavity into a saliva collection reservoir; deactivating said pumping of saliva into the saliva collection reservoir; And then injecting the fluid from the fluid supply reservoir into the mouthpiece for cleaning the oral cavity. 2. The method of claim 1, wherein the pumping of saliva into the saliva collection reservoir is deactivated after a predetermined number of bites on said switch. 3. The method of claim. 1, in which the injection of fluid from the fluid supply reservoir into the mouthpiece for cleaning the oral cavity is started after a predetermined number of bites of the specified switch. 4. The method of claim 1, wherein the pumping of saliva into the saliva collection reservoir is deactivated after three or more bites on said switch. 5. The method of claim 1, wherein said switch comprises a timer component. 6. The method of claim 5, wherein the pumping of saliva into the saliva collection reservoir and said timer component are triggered by biting said switch. 7. The method of claim 6, wherein the saliva injection into the saliva collection reservoir is deactivated after a predetermined time elapses from the start of said timer component and the injection of fluid from the fluid reservoir into the mouthpiece is started. 8. The method according to claim 1, further comprising the step of analyzing saliva collected using a method selected from the group consisting of immunochromatographic analysis, microfluidic immunoassay, DNA-DNA hybridization, color measurements, photoimaging, gas chromatography, zinc oxide semiconductor sensors, quantitative light fluorescence and quantitative polymerase chain reaction. 9. The method of claim 1, further comprising administering an agent selected from the group consisting of a saliva sampling stimulating agent and a thickening agent. 10. A method for collecting and analyzing saliva samples from the oral cavity of a mammal, including: placing a device suitable for collecting said sample of said saliva in said oral cavity of said mammal, comprising: a mouthpiece containing a chamber formed by the front and rear inner walls and the main inner wall of the specified mouthpiece, and the specified main wall passes between the specified front and rear inner walls, while the mouthpiece contains a chamber formed by the front and rear inner walls and the main wall of the specified mouthpiece, and said main wall extends between said front and rear inner walls, and each of said front and rear inner walls of said chamber contains a plurality of holes, wherein said mouthpiece further comprises a first distributor for accommodating the first part of the fluid and directing said first part into said chamber through said openings in said front inner wall, a second distributor for accommodating a second part of said fluid and directing said second part into said chamber through said holes in said rear inner wall, a first port for supplying said first part of said fluid to and from said first distributor , a second port for supplying said second portion of said fluid to and from said second distributor, and a switch located in said mouthpiece at a location susceptible to biting movement, said switch being activated by biting it; And means for collecting said saliva sample from said oral cavity, collecting said saliva sample from said oral cavity; and analyzing said saliva sample; activating said switch located in said mouthpiece by biting said switch to start collecting saliva from the oral cavity; deactivation of saliva collection; And starting the cleaning process. 11. The method of claim 10, further comprising reciprocating means comprising a pumping system for alternately: (i) directing fluid into said chamber through said first distributor and out of said chamber through said second distributor, and (ii) directing fluid into said chamber through said second distributor and out of said chamber through said first distributor. 12. The method of claim 10, wherein said means for collecting said saliva sample are selected from the group consisting of a dispenser designed to collect said saliva, an opening, and a plurality of nozzles spaced at intervals around said mouthpiece, said openings being at least in at least one of said inner walls, at least one of said first and second distributors, and at least one of said first and second ports. 13. The method of claim 10, wherein said means for collecting said saliva sample are selected from the group consisting of said openings in at least one of said inner walls, at least one of said first and second distributors, and at least one from the specified first and second ports.

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