阅读说明：本技术 用于定制化和个性化的口腔冲洗器的系统和方法 (System and method for customized and personalized oral irrigators ) 是由 文华峰 张朝晖 于 2020-04-29 设计创作，主要内容包括：一种定制化口腔冲洗器,其适于使用者的牙列,具有指向要冲洗的区域的多个喷嘴或切口开口。在一种情况下,使用者可以通过用牙齿咬合来锚定这样的设备,并冲洗牙齿和牙龈,尤其是牙齿之间和牙龈下面。这样的设备是快速且有效的。这将对每个人都有好处,但对忙碌的专业人士、儿童、老年人、残障人士、残疾人和其他清洁牙齿有困难的使用者(例如佩戴诸如支具的牙科设备的人)将尤其有益。该设备意在将诸如刷牙和牙线清洁的口腔护理程序结合在一种实例中,并且与常规的刷牙和牙线清洁以及常规的单通道口腔冲洗器相比,该设备将产生更好的牙齿卫生并具有更好的一致性。(A customized oral irrigator, adapted to the dentition of a user, has a plurality of nozzles or incision openings directed at the area to be irrigated. In one case, the user may anchor such a device by engaging with teeth and rinsing the teeth and gums, particularly between the teeth and under the gums. Such a device is fast and efficient. This would be beneficial to everyone, but would be particularly beneficial to busy professionals, children, the elderly, disabled, handicapped, and other users who have difficulty cleaning their teeth (e.g., those wearing dental equipment such as braces). The apparatus is intended to combine oral care procedures such as brushing and flossing in one instance and will result in better dental hygiene and better consistency than conventional brushing and flossing and conventional single-pass oral irrigators.)

1. A computer-implemented method for producing an appliance for rinsing teeth and gums, the method comprising:

providing an initial digital data set representing tooth and gum geometry and conditions;

specifying a configuration in the digital data set for a set of nozzles or cut-out openings along one or more appliances, wherein the one or more appliances are configured to conform to the tooth and gum geometry from the digital data set, and wherein the set of nozzles or cut-out openings are configured to provide irrigation for the tooth and gum according to an optimization function; and

producing the one or more instruments having the set of nozzles or cut-out openings according to the digital data set.

2. The method of claim 1, wherein providing the initial digital data set representing tooth and gum geometry and conditions comprises scanning a three-dimensional model of a subject's teeth and gums.

3. The method of claim 1, wherein providing the initial digital data set representing tooth and gum geometry and conditions comprises imaging one or more images of a subject's teeth and gums.

4. The method of claim 1, wherein providing the initial digital dataset representing tooth and gum geometry and conditions comprises providing the initial digital dataset via x-ray, ultrasound, infrared, CT scan, or MRI of a subject's teeth and gums.

5. The method of claim 1, wherein providing the initial digital data set representing tooth and gum geometry and conditions comprises inputting a digital representation of closed and open bite relationships of the teeth.

6. The method of claim 1, wherein specifying a configuration for a set of nozzles or kerf openings comprises specifying a jetting direction, a fluid volume, a fluid pressure, or a fluid velocity.

7. The method of claim 1, wherein the optimization function comprises finite element analysis, finite difference analysis, flow dynamics analysis, or experimental data optimization.

8. The method of claim 1, wherein the optimization function comprises a device volume minimization algorithm, a device cost minimization function, an assignment of a weighting function to arch regions, or an assignment of an expansion function to arch regions.

9. The method of claim 1, wherein the optimization function comprises an assignment of an inner wall cut opening function of an arch region, wherein the cut opening is angled opposite to a water flow direction.

10. The method of claim 9, wherein the incision opening is further configured in a curved or arcuate shape at an inflow incisor region.

11. The method of claim 1, wherein the optimization function includes placing a movable portion inside an inner wall cutout opening to regulate water spray.

12. The method of claim 1, wherein the optimization function comprises providing support posts along an inner surface of the one or more appliances to provide clearance to the teeth.

13. The method of claim 1, wherein the optimization function comprises providing a closure wall snap fit for contact against the gum to prevent excess liquid from entering the subject's mouth.

14. The method of claim 1, wherein the optimization function includes providing a drain for removing excess liquid.

15. The method of claim 1, wherein producing the one or more appliances comprises manufacturing a mouthpiece.

16. The method of claim 15, wherein the mouthpiece includes a cushioning portion.

17. The method of claim 16, wherein the cushioning portion comprises a membrane and a flow connector for passing a liquid.

18. The method of claim 1, wherein the one or more appliances comprise a mouthpiece having an inflow tube for receiving liquid from a pump in fluid communication with the set of nozzles or incision openings.

19. The method of claim 1, wherein producing the one or more appliances comprises a mouthpiece having at least one post structure for offsetting the mouthpiece from a tooth.

20. The method of claim 1, wherein producing the one or more appliances comprises a mouthpiece having a thin plate design that follows the surface curvature of the dentition.

21. The method of claim 1, wherein producing the one or more appliances comprises a mouthpiece having an upper piece and a lower piece configured to be connected to each other.

22. The method of claim 1, further comprising pre-washing the one or more implements prior to use by a subject.

23. A computer program product for producing an appliance for rinsing teeth and gums, the product comprising instructions operable to cause a programmable processor to:

generating a digital representation of the mouthpiece;

specifying a set of nozzles or cut-out openings and their desired spray attributes: a target, liquid pressure, velocity, spray pattern to rinse the teeth and gums through a nozzle or an arrangement of incision openings, wherein at least some of the nozzle or arrangement of incision openings are represented by a digital data set, wherein the design of specified spray attributes comprises rinsing teeth and gums according to an optimization function; and

generating one or more appliances from the digital data set, wherein the appliances comprise a mouthpiece having an inflow tube for receiving liquid from a pump and a nozzle or an incision opening for ejecting liquid according to desired ejection properties to rinse the teeth and gums.

24. A system for treating teeth and gums, comprising:

a processor;

a display device coupled to the processor; and

a data storage device coupled to the processor, the data storage device storing instructions operable to cause the processor to:

generating a digital representation of the mouthpiece;

specifying a set of nozzles or cut-out openings and their desired spray attributes: a target, liquid pressure, velocity, spray pattern to rinse the teeth and gums through a nozzle or an arrangement of incision openings, wherein at least some of the nozzle or arrangement of incision openings are represented by a digital data set, wherein the design of specified spray attributes comprises rinsing teeth and gums according to an optimization function; and

generating one or more appliances from the digital data set, wherein the appliances comprise a mouthpiece having an inflow tube for receiving liquid from a pump and a nozzle or an incision opening for ejecting liquid according to desired ejection properties to rinse the teeth and gums.

25. The system of claim 24, wherein specifying further comprises instructions to generate the digital data set based on an initial digital data set until the digital data set representing acceptable injection properties is obtained.

26. The system of claim 24, wherein the optimization function comprises rinsing teeth using a flow analysis tool, a simulated tubing management tool, a genetic algorithm, a cost minimization, or a space minimization algorithm.

Technical Field

The present invention generally relates to a device for a customized and personalized oral device on which a user bites and uses a water jet to rapidly, efficiently and effectively rinse teeth and gums.

Background

(Water Pik, Inc., Fort Collins, CO) and other conventional oral irrigators typically include a base unit having a reservoir, and a separate hand-held portion having a tip or rod connected to the reservoir by a tube. In use, the user directs a fluid stream or pulse by pointing the tip of the hand-held portion at the user's gum line at a desired location. The benefits of regular oral rinses of the teeth and gums are well known, but because conventional oral rinses have only one tip directed at the tooth and gum area, and are often hand-held, conventional oral rinses are difficult to align with the area to be rinsed, and often require a long time to traverse the entire oral cavity.

What is needed is a custom made and personalized oral irrigator that is adapted to the dentition of the user, having multiple nozzles or cut-out openings to point to the exact area to be irrigated.

US 2019/0142559 a1 entitled "TOOTH CLEANING APPLIANCE" to Yan SUN describes a technical advance to a guided convenient, efficient, economical and effective dental cleaning appliance according to aspects of the present disclosure. In sharp contrast, the appliances, structures, methods and techniques according to the present invention use mouthpiece appliances, water jets, brushes and sonic/ultrasonic waves as shown and described to produce effective and inexpensive cleaning appliances that can be customized and/or tailored to a particular user's particular dental hygiene requirements. However, the reference describes a sprinkler-like system in the mouth where water comes from a water pipe and then splits into different water channels, each time changed, a jet of water is installed along the teeth to be sprayed. In addition, different toothbrush heads may be fitted with a jet of fluid. The described apparatus is not practical for constructing a channel for application to a region of interest. Multiple parallel channels may also be required to apply pressure, which makes the apparatus more complex and cumbersome and expensive. The result may be good or bad and not provide good coverage for all teeth. A more elaborate system is needed to effectively spray rinse teeth.

US 2018/0344440 entitled "ORAL CARE CLEANING SYSTEM utilzing incorporated flud" to Johnson & Johnson Consumer inc. provides an ORAL care system having an appliance with a first plurality of nozzles and a second plurality of nozzles configured to be held in a user's mouth, wherein the first and second plurality of nozzles are in FLUID communication with one or more surfaces of the user's mouth; a gas source; a source of liquid; and a fluid controller for directing the entrained fluid to the appliance. Methods of cleaning, or otherwise providing oral care benefits to one or more surfaces of the oral cavity are also provided. This device uses two layers of nozzles, one gas and then one liquid, to power clean the teeth; however, such a system is not practical because the teeth are sensitive to water pressure and excessive water is difficult to drain from the mouth.

US 10,195,006 entitled "intraral DENTAL occlusion application" describes a dual purpose bite guard and IRRIGATION device. The appliance may protect the user's teeth from damage caused by bruxism and even provide the user with the ability to effectively rinse some or all of the difficult areas of the dentition. The appliance includes at least one port configured to receive an irrigation fluid or an irrigant. The port may be attached to a fluid source, such as a faucet, water flush device, or other mobile fluid supply. This is more like a drip irrigation system where a sinusoidal-like pattern of drippers is laid on the occlusal surface of the teeth and drips a liquid to rinse the teeth. Drippers can wash teeth slowly, but these drippers may take a long time to clean teeth and may not be able to clean hard to reach areas.

US 2019/0000599 entitled "SYSTEMS AND METHODS FOR personal ORAL IRRIGATION" describes a system and method FOR providing PERSONALIZED ORAL IRRIGATION. One variation of a system for personalized oral rinsing includes a fluid reservoir and a customized oral insert in fluid communication with the fluid reservoir. The oral insert includes an arrangement of fluid openings positioned based on individual oral or dental structures of the user's teeth to provide customized fluid flow through the user's teeth. However, this system has fundamental limitations because the conduit structure restricts flow from one point of the dental arch to another, the pressure is much reduced within the conduit structure, and to compensate for pressure drop, a manifold conduit structure is proposed. The manifold may have several parameters that can be adjusted to control the fluid velocity at each nozzle, but such a configuration requires tubing to carry the liquid to different portions of the teeth and adds additional thickness to the device, thus making the device more cumbersome and making it more difficult for the user to place the upper and lower arch portions into the mouth. The separate placement of the upper and lower portions allows for longer cleaning times, which can be more labor intensive and inconvenient for the user. While this reference describes a number of nozzle designs for different dental structures, such designs are predefined and laid out through the device, such designs cannot cover complex dental structures that require more dynamic, shape-based dental-like structures. Thus, the reference focuses on a pre-designed layout of the nozzle design, where the nozzles cover the power cleaned portion of the teeth, leaving areas that cannot be properly cleaned. The layout grid must be covered area by area in order to completely clean the area in the event of tooth crowding. Furthermore, there is no place to insert the designed nozzle. Smaller nozzles do not produce the required hydraulic flow and are also difficult to manufacture. The limitation is that the piping nozzle structure lacks flow dynamics design to produce a true dynamic exit of the liquid, which is a limitation.

US 2018/0116773 entitled "CUSTOM-MADE ORAL HYGIENE DEVICE FOR DAILY TEETH CLEANING AND polising" describes a CUSTOM-MADE dental irrigation apparatus having a user dentition model; a custom-made mouthpiece made according to the user's dentition model; a pump configured to pump fluid into the mouthpiece; a suction pump configured to remove fluid from the mouthpiece; a fluid tank; and a controller. The custom-made mouthpiece is configured to deliver fluid to a dental target upon removal of the used irrigation fluid. The mouthpiece is manufactured using 3D printing techniques. The mouthpiece is designed in two pieces to cover an upper portion of the dental target and a lower portion of the dental target, respectively. The mouthpiece has an inner surface that follows the shape of the user's dentition model, wherein once the mouthpiece is placed into the user's mouth, the inner surface contacts gingival tissue to form a sealed space, whereby fluid is delivered to the dental target and removed from the sealed space. Such application utilizes close contact with the gums to obtain an enclosed space so that the liquid can be retained in the mouth during rinsing. However, this design is not well suited for power wash applications where a larger volume of space is required to hold the water and quickly drain to sweep the road for more liquid power.

US 2011/0318705 entitled "HYDRO CLEAN AUTO FLOSS" provides a molded mouthpiece (mouthpiece) of the mouthpiece type configured to be U-shaped to conform to the contours of a set of human teeth, the mouthpiece having a trough to receive the teeth and further including a rinsing water flow member at the front thereof, the member consisting of an attachable tube arrangement, allowing a user to FLOSS all the teeth at once by means of pressurized water, whether at home or on the road. A series of small circular openings are located along the periphery of the mouthpiece to serve as outlets for water. An attachment point for the irrigation water flow component is located at the front of the mouthpiece. The flushing water flow member comprises one central inlet nozzle and two outlet nozzles positioned on each side of the inlet nozzle. All these nozzles are designed to receive the tube by force fit. At the opposite end of the inlet hose is a spout adaptor configured to accommodate most sink faucets. The use of multiple jets in a U-shaped carrier to floss the teeth would only flood the mouth with water if not customized for individual teeth.

US 9,788,922 entitled "SYSTEMS AND METHODS FOR ReMOVAL OF DENTAL BIOFILM USE IRRIGATION" describes a custom fit tray that fits over the teeth and seals against the gums OF a mammal. A plurality of ports are embedded in the tray, each port being in fluid communication with a hose or line supplied with a vacuum or irrigant/fluid source. Providing a small space between the tray and the teeth for the fluid to flow around the teeth. A route controller (router) may be connected to the rinse fluid supply reservoir and vacuum pump to direct fluid or vacuum to the various hoses and change routes over time to achieve optimal cleaning. Air may be injected into the cleaning fluid in varying amounts to create bubbles, droplets, and/or clusters of cleaning fluid to increase and concentrate the hydrodynamic force of the fluid upon reaching the teeth. The described device uses a biofilm connected to an inlet and an outlet. This may be a cheaper way of producing a customised water jet device by deforming the biofilm into the shape of the teeth, but the effectiveness of the cleaning may be poor as each droplet is evenly distributed.

US 2013/0260332 entitled "AN ORAL HYGIENE APPLIANCE" is provided as a member having upper and lower appliances formed by AN arcuate channel for placement over the upper and lower teeth and gum line of a wearer. The passageways include inner and outer layers that sandwich an internal pathway for the delivery of pressurized cleaning solution therethrough. The path is a network of small tubes or a path formed between layers of channels with a main conduit, branches and exits through the inner layers of the channels. The front portion of the instrument is connected to at least one guide tube. The guide tube is further connected to an external fluid pump and a reservoir of cleaning solution that is pumped into the channels of the upper and lower appliances and discharged from the outlet to spray remove plaque, tartar and food particles. The device may be used to replace or supplement traditional toothbrush cleaning practices; however, this device uses tubing and branching structures and irrigation, which makes it difficult to place the power washer device in the mouth in confined spaces.

US 2017/0056143 entitled "AN APPARATUS FOR CLEANING THE ORAL CAVITY" includes a main body including AN insertion groove into which a user's teeth can be inserted, a plurality of injection holes and a plurality of suction holes formed on AN inner wall of the insertion groove; a feed pipe for supplying a cleaning liquid to the plurality of injection holes; a discharge pipe through which the cleaning liquid is discharged to the outside through the plurality of suction holes; and a switching member for switching an injection direction and a suction direction of the cleaning liquid, wherein the main body includes a first inner space communicating with the plurality of injection holes and a second inner space communicating with the plurality of suction holes. This device is another application that allows water to enter and rinse teeth, and has a pump and a switch to drain functions at the tube.

US 2018/0140402 entitled HIGH-PRESSURE-WATER TOOTHBRUSH AND U-SHAPED forced JET-WATER TOOTHBRUSH, provides a HIGH-PRESSURE WATER TOOTHBRUSH AND its U-SHAPED JET cleaning tank STRUCTURE comprising: a handle and a U-shaped jet cleaning tank disposed at an end of the handle. The U-shaped jet cleaning tank structure has a first side wall and a second side wall facing the first side wall, and each of the first side wall and the second side wallOne having an inner wall surface provided with a plurality of nozzles. Both the inside and outside of the tooth surface and the tooth spaces can be rinsed simultaneously for the purpose of cleaning the teeth quickly and efficiently. The U-shaped jet cleaning bath can be slid along the arch like a toothbrush part-by-part cleaned or all the U-shaped jet cleaning baths are attached to cover the entire arch so that the teeth can be power cleaned in one time. However, the nozzle is not custom designed, which allows the spray to look like a multi-jet nozzleThe device is passed anywhere.

CN 208864531 entitled HIGH-PRESSURE TOOTHBRUSH WATER SPRAY TOOthbrush AND ITS U-SHAPED slotted TOOTHBRUSH describes a HIGH-PRESSURE water TOOTHBRUSH STRUCTURE AND ITS U-SHAPED slot STRUCTURE, comprising: the spray washing device comprises an operating handle and a U-shaped spray washing box arranged on one side of the operating handle, wherein the U-shaped spray washing box is provided with a first side wall and a second side wall which face each other. And a plurality of liquid ejection nozzles are provided in the first and second side walls of the side wall, respectively. However, the device is again shown to contain no custom U-shaped models.

KR 101298491 entitled "amuth CLEANSER AND A manual METHOD for cleaning teeth" is provided for cleaning teeth by customizing a base having a teeth receiving unit of upper and lower teeth in accordance with a dental arrangement. A method of manufacturing an oral cleaner is described comprising the steps of: a first step of taking an individual impression of a tooth; a second step of manufacturing a plaster model by pouring plaster into the impression; thirdly, using plasticized silicon to close the shape of the gypsum-formed tooth so as to form a space through which water can flow out; a fourth step of manufacturing a base in conformity with the structure and arrangement of the teeth by using a heat vacuum compression mold press (heat vacuum compression mold) on top of the closed mold; fifthly, breaking the formation of the base and penetrating through a plurality of water flow nozzles; sixthly, sealing by using plasticized silicon; a seventh step of positioning an internal adapter in which a hole is formed in an upper middle portion of the plasticized silicon; an eighth step of manufacturing a shell by using a hot vacuum compression molding press on the top of the closed mold; and a ninth step of forming a center hole in conformity with the hole of the internal adapter and inserting the external adapter into the center hole. The described apparatus provides a method of manually forming a mouth rinse using a mold, plaster, silicon, and while it may be inexpensive to manufacture, the apparatus may not be effective in cleaning teeth.

US 8,684,956 entitled "ORAL CARE DEVICE" describes a device for directing liquid onto multiple surfaces of the ORAL cavity, the device comprising a chamber for holding the liquid adjacent the surfaces, wherein the chamber is defined by a front interior wall, a rear interior wall, and a base interior wall of the device, and the front interior wall and the rear interior wall each comprise a plurality of openings, the device further comprising first and second manifolds, first and second ports; and means for providing an effective seal of the device within the oral cavity. This is another multi-jet cleaning device that cannot be customized for individual teeth.

To effectively clean the teeth, the cleaning cannot be blind, but is ideally tailored to direct the water in the correct direction, and also with the proper pressure. To achieve this, a customized device based on tooth surfaces and internal structures is needed to target the water flow so that the product is compact enough to be easily and quickly inserted into the mouth to clean the teeth so as not to leave any blind spots that lack cleaning.

Summary of The Invention

According to one broad aspect of one embodiment of the present invention, disclosed herein is a custom-made mouthpiece, typically 3D-printed, such a device having at least one connector connected to a pump to pump liquid or air into the device, the liquid being mixable with water, a tooth cleaner or a tooth whitener.

The user may anchor such a device by engaging the teeth, initiate irrigation, and irrigate the teeth and gums in one treatment. In rare cases, if the water pressure is not able to rinse all areas in one treatment, a switch can be installed to rinse one arch or quadrant (quadrant) at a time. Such a device is fast and efficient. This would be beneficial to everyone, but would be particularly beneficial to busy professionals, children, the elderly, disabled, handicapped, and other users who have difficulty cleaning their teeth (e.g., those wearing dental equipment such as braces). The device is intended to combine oral care procedures such as brushing and flossing in one instance and will result in better dental hygiene and with better consistency.

In one example, there are many custom designed and personalized nozzles or cutout openings, each for its region of interest.

Inside the apparatus, the flow control system is designed to ensure that the pressure delivered to each nozzle or slit opening reaches the desired spray properties: target, liquid pressure, velocity, spray pattern. Such a flow control system may include one or more reservoirs and a stopper. The flow control system may also contain various winding channels that often do not cross each other. Such flow control may be achieved by using design tools such as flow dynamics simulation engines, for example, flow dynamics analysis, finite element analysis, finite difference analysis.

In another example, a hydrodynamic brush may be attached to the described nozzle or cutout opening. In addition, sensors or sensor meters may also be attached to control water flow and pressure when needed. In addition, a controller (sometimes using software) may be used to adjust the sensor values to adjust the flow as needed.

In another example, the body may further comprise a motor, a pump, and a drive mechanism coupling the motor to the pump, wherein the pump controllably delivers fluid from the water bottom seat to the nozzle or the cutout opening. An on/off controller or switch may be used to activate and deactivate the motor.

In another example, the device may further include one or more drainage tubes that direct excess fluid away from the oral cavity.

In another example, a software application may be used to track usage. In addition, the software can adjust brushing times, increase concentration zones or decrease intensity in certain areas, for example, due to sensitive teeth or gums.

Brief Description of Drawings

Figure 1 illustrates a customized and personalized oral irrigation device according to an embodiment of the present invention in which a mouthpiece customizes the profile according to the user's dentition as well as the inflow tube, the outflow tube, and the nozzle or incision opening.

Fig. 2 illustrates a customized liquid flow control design according to an embodiment of the present invention, wherein the goal is to achieve each desired spray attribute for each nozzle or cutout opening, wherein a small reservoir and flow obstruction are used.

Fig. 3 illustrates another customized liquid flow control design according to an embodiment of the present invention, wherein the goal is to achieve the jetting properties of each desired nozzle or cutout opening, wherein different flow paths are used.

Fig. 4 illustrates a design flow diagram of a customized oral rinse device according to an embodiment of the present invention.

FIG. 5 illustrates a design that is analyzed (sometimes iteratively) using a flow analysis system to obtain desired spray properties, according to an embodiment of the present invention.

FIG. 6 illustrates a cross-section of a design of a customized oral irrigation device according to an embodiment of the present invention, wherein the device is offset from the crown portion of the tooth, leaving room for powered spraying of liquid to the crown, and in close contact with the gums, to control outflow of liquid and discharge.

Figure 7 illustrates another customized oral irrigation device in which the mouthpiece customizes the profile to the user's dentition and each arch is fabricated as a separate unit. According to an embodiment of the invention, the membrane is made with an inflow tube, a connector to the individual mouthpiece, which provides an inflow and an outflow for each arch mouthpiece.

Fig. 8 shows an occlusal view of the diaphragm, which has a horseshoe-like shape, adapted to the shape of the upper and lower arches.

Figure 9 provides a detailed step of how to design the mouthpiece and diaphragm.

Fig. 10 illustrates such a workflow with a membrane.

Figure 11 illustrates a support structure design that offsets the mouthpiece from the teeth to provide proper anchoring and cleaning space.

Fig. 12 illustrates a shell design, wherein the device is made from an enclosed volume between two laminae, wherein such laminae are generally contoured to the tooth surface and have an internal support structure.

FIG. 13 illustrates a method in which one or more flexible material portions connect an upper portion and a lower portion, such adjustment being tailored to bite estimation errors.

Figure 14 illustrates another embodiment, mating features.

Fig. 15 illustrates a housing for a pre-wash apparatus.

FIG. 16A illustrates a cross section of the inner wall of the water jet channel.

Fig. 16B and 16C illustrate cross sections of the water jet channel inflow direction in relation to the anterior teeth (a) and the posterior teeth (P).

FIG. 17 illustrates a cross section of the inner wall of the water spray channel where the movable part is placed.

FIG. 18 illustrates a workflow of how such a design is implemented.

Detailed description of the invention

Disclosed herein are various embodiments of a custom-made oral rinse device. Referring to fig. 1, the device 101 is shaped like a mouthguard, but is custom designed to be offset from the user's crown by a distance, typically greater than, for example, 0.1 mm but less than 100 mm. The custom designed anchor post 102 is designed to anchor the irrigation device to the tooth. An inflow tube 103, often connected to the outlet of the oral pump unit, is used for pumping in irrigation liquid. The inflow tube is connected to a plurality of nozzles or custom slit openings 104 (shown as a few examples only) that are also custom designed to align with the desired area. The one or more drain holes 105 are designed to pump or drain excess liquid out of the device. Each nozzle or opening is custom designed to achieve the desired spray attributes: flow pressure, flow velocity and flow rate, depending on the irrigation area, tooth sensitivity, cleanliness of the teeth or gums.

In another embodiment, a plurality of inflow units, nozzles or incision openings and discharge holes are designed so that a portion of the teeth can be rinsed at a time. Such a design may be desirable for miniaturisation of the irrigation pumping unit, particularly for portability or travel, or the need to have a battery powered pump.

On the inner surface of the rinsing device, cameras or sensors can be mounted to sense the cleanliness of the respective areas, and a suitable control unit can be mounted to adjust the rinsing process based on the sensed data.

The influent liquid may include, but is not limited to, whiteners, bleaches, cleaning solutions, anesthetics, or water, and the liquid may externally control any desired influent sequence.

Once the liquid is pumped into the inflow tube, it is dispersed through specially designed channels inside the flushing device and eventually reaches each individual nozzle or slit opening. Each nozzle or cutout opening is custom designed to target a region of interest with desired flow control such as, but not limited to, velocity, pressure, volume, pulse pattern. To better manage the flow, different designs are implemented. Fig. 2 shows one of the embodiments of flow control. Once the influent stream 201 enters, the special reservoir 202 is designed to hold the liquid to a certain volume and better control the filling rate. Sometimes, some stopper units 203 are designed to combine the reservoir and the stopper. Fig. 3 shows another embodiment of flow control. Once the influent stream 301 enters, a particular path 302 (e.g., generally curved) is designed to direct the liquid to travel in a pattern to achieve a desired pressure, volume and velocity at the nozzle or cutout opening 303.

Figure 4 depicts more detailed steps of how to design the mouthpiece device. First, 401, a digital representation of a user's dentition is obtained. Such acquisition may be accomplished by taking an impression of the tooth and scanning it using a scanner; or using intraoral scanners, e.g.The scanner (3Shape A/S, Denmark, Copenhagen) scans the user' S teeth directly. Sometimes, due to the high quality photographs of these devices and better image registration tools, good dentition models can be obtained using only intra-oral cameras or mobile phone cameras. Then, the teeth and gums are identified 402. Typically, artificial intelligence based tools, such as the uDesign software developed by the laba systems corporation (redwood, ca), can automatically detect these features. The tooth portion is then dilated 403, leaving a jet space for the nozzle or incision opening. Some sharp features are also smoothed. The detailed process will be described in fig. 6, and fig. 6 shows a cross-sectional view. 404, various mating posts are designed to securely anchor the mouthpiece to the tooth and to maintain a majority of the area of the mouthpiece at a desired distance. The post may have a sensor in place that detects whether the mouthpiece is properly placed on the tooth. 405, the layout of the nozzle or cutout opening, inflow tube or tubes and exhaust ports is designed to include the desired spray attributes: pressure, target, speed, etc. 406, the inner mouthpiece is designed to achieve the desired nozzle or slit opening behavior. And the outer surface is designed to enclose the tube and the reservoir. Such designs are exported into a manufacturable process to produce mouthpiece devices; such a manufacturing process may be, but is not limited to, a 3D printing process.

One desirable feature is flow control and how to custom design a mouthpiece that receives the incoming liquid and properly distributes the liquid to the various nozzles or incision openings at the correct flow rate, velocity, pressure, etc. Fig. 5 illustrates one of the flow diagrams of such a design. First 501, a 3D model of a user's mouthpiece is entered. Then 502, the inflow pressure and the desired outflow nozzle or slit opening flow are also input. Based on the inputs and preliminary calculations, an initial design of a tube, reservoir, or obstruction is designed and placed within the mouthpiece model. 503, based on suitable flow analysis tools employed by the model. Such an analysis tool may be, but is not limited to, a finite element analysis model, wherein the tubes, reservoirs, obstructions are partitioned into individual finite elements by a mesh. These elements may be, but are not limited to, tetrahedral or hexahedral elements; such a mesh may be generated by meshing known tubes, reservoirs, obstructions from known templates. Flow analysis is run to generate simulated nozzle or kerf opening flow properties including pressure, velocity, spray range, etc. 504. The result is then compared 505 with the expected result and the tolerance is checked and if the result is within the range of the expected result we have achieved a preliminary design. 507, otherwise, based on the difference, modifying the design of the tube, reservoir or stopper, and performing the design process again; 506 until one of the designs converges to the tolerance of the nozzle or kerf opening properties. Sometimes, but rarely, the mouthpiece profile may also need to be changed due to the particular oral conditions. Each custom and personalized mouthpiece produced will require the above process.

To better manage flow and drainage, preferably closing the space between the inner surface and the tooth, figure 6 provides a more detailed illustration of the cross-sectional profile with the shell and tooth where 601 is the tooth/crown portion, 602 is the associated gum, and the shell device 603 has an offset or gap 604 from the crown 601 and is in snug fit or contact 605 with the gum. The gap between the teeth and the device is achieved by placing various anchoring posts 606 in the mouthpiece; such a gap enables the nozzle or incision opening 607 to effectively spray the teeth and excess liquid to be effectively drained. This is particularly useful for children, the elderly and disabled who may not be able to handle the liquid in the mouth well and may accidentally swallow the liquid in the mouth.

The inflow tube is typically accessed through the buccal surface of the incisors, and flow dynamics algorithms have been developed to enable the liquid to be delivered distally through the device as quickly as possible. To make the device easy to wear and comfortable to use, we usually keep the thickness of the buccal and occlusal surfaces as thin as possible. To allow maximum passage, for anterior teeth, the thickness may be increased on the lingual side and the height may also be increased on the buccal side. Such optimization is typically achieved by assigning weighting factors in the zones to simulate the desired device shape to achieve the desired spray properties.

To push out the material in the interproximal area, the nozzle or incision opening is spread out to be as gradual as possible towards the occlusal surface and thus towards the occlusal surface. For the gingival area, the nozzle or incision opening is spread from the gingival low point to both sides to point gradually upward.

Fig. 7 illustrates another embodiment of a custom-made oral irrigation device in which the mouthpiece is custom-contoured to the user's dentition and each arch 701 is made as a separate unit. A membrane 702 is made to lie between the two mouthpiece, with the cross-section shown here, and is connected to the inflow tube, the membrane having a reservoir 703 holding liquid. The membrane also has a tube connector 704, the tube connector 704 may be a female feature for receiving a connector 705, and the connector 705 may be a male feature for each mouthpiece. Similar configurations may also be used for drainage management according to embodiments of the present invention, which provide inflow and drainage ports for each arch mouthpiece.

Figure 8 shows an occlusal view of the diaphragm, which is horseshoe-like in shape, adapted to the shape of the upper and lower arches. Several connectors 801 connect the flow to the upper and lower arches. The connectors may be connected to individual reservoir units 802 with each unit connected to the main inflow pipe 803 or each unit in series with each other towards the main inflow pipe 803. Outflow or drainage pipes are managed in a similar manner. Such management may provide better flow control because valves may be placed between the cells to control each cell to achieve a desired pressure. Such a design also allows the mouthpiece to be segmented rather than a separate unit, one segment after the other, resulting in a simpler internal flow tube, obstruction, reservoir design.

Figure 9 provides a detailed step of how to design the mouthpiece and diaphragm. First, 901, a digital representation of a user's dentition is acquired, such acquisition may be accomplished by taking a dental impression and scanning it using a scanner; or directly scan the user's teeth using an intraoral scanner (e.g., Trios). Sometimes, due to the high quality photographs and better image registration tools in such devices, good dentition models can be obtained using only intra-oral cameras or mobile phone cameras. An open bite relationship for the user is then obtained 902, and the user can take an open bite impression to register it to both dental arches or an open bite scan or image to register to both dental arches. Sometimes, this can be calculated by placing both the lower and upper arches in the best bite fit position without the need for a bite impression or bite scan or bite image. The open bite relationship differs from the typical bite relationship in that it requires the teeth to be hinged to the open bite position, which creates space for the two braces and has sufficient space for the insertion of the intermediate diaphragm therebetween. To obtain the correct gap, a special bite blocker or impression tray may be required to take an open bite impression or scan when the user has the desired open bite position. Then, both mouthpiece are designed following the same procedure described in fig. 4, while taking into account the septum to ensure that the connector is within the correct range. 904, if necessary, adjust the snap relationship. 905, the diaphragm is designed to fit both braces when each brace is in place. The flow-fitting connectors between the diaphragm to the upper arch and the diaphragm to the lower arch are designed 906 to manage inflow from the diaphragm to the mouthpiece and outflow from the mouthpiece to the diaphragm. The diaphragm may be prefabricated in several types to cover all arch shapes.

Fig. 10 illustrates such a workflow: step 1001 is the same as step 901 and step 1002 is the same as step 902. 1003, one of the prefabricated diaphragms is selected by comparing the arch forms that best match to both the upper and lower arches. 1004, when the middle compartment film is in place, the bite relationship is adjusted, if necessary, to provide sufficient space for the two braces. Both braces are designed to fit the chosen diaphragm 1005. The corresponding connector is then designed to mate with the selected septum. Corresponding inner tubes and discharge ports are also designed.

While this design allows the upper and lower sleeves to be snapped to the septum prior to use, the design has several advantages:

1. the diaphragm and mouthpiece may be made of different materials depending on their use. In one example, the diaphragm may be made using a material like durable rubber, the diaphragm having the desired reservoir, while the mouthpiece may be made using a harder material, such as ABS, which provides designed ejection properties.

2. The diaphragm and mouthpiece may be manufactured by different manufacturing methods, for example, the mouthpiece may be 3D printed to accommodate complex designs of tubing, obstructions, and reservoir structures. However, due to their complex shape and their need for water resistance, it is difficult to place electronic components in such a structure. However, if the membrane is made by other methods (e.g. casting), the electronic components can easily be placed inside. Furthermore, mechanical flow control elements can also be easily placed therein when desired. For example, the diaphragm may be divided into smaller units, and each unit may have its own outflow and discharge port, serving a small portion of the mouth, and have valves that may be opened and closed at different times, like sprinklers. This is important if a low power pump unit is required, for example in a traveller's kit powered by a battery pack.

3. As illustrated in fig. 10, the diaphragm can be pre-fabricated into several standard shapes based on common arch forms, and then the best matching method can be used to find and select the best pre-fabricated diaphragm and change the mouthpiece design for the diaphragm, rather than custom-making a single custom-made diaphragm. This can reduce the manufacturing cost.

4. Because the diaphragm can be made of a somewhat soft material, the diaphragm is well tolerant of splayed bite design errors and provides some cushioning for proper bite of the device to the tooth.

5. The cost of the electronics and flow control elements is high and therefore it is economical if they are placed in a diaphragm that lasts longer than the mouthpiece. The mouthpiece can be 3D printed to many groups to fit the same diaphragm. Thus, the overall cost will be lower in this design.

6. The user's oral condition may change over time. When the user's oral condition changes, only a new mouthpiece design will be required, and the new design can fit the currently used diaphragms, rather than having to replace all three components.

The liquid pump is a standard pump with a connector to the inflow tube. On the pump, a timer can be installed to record the usage of the device, and such data can be wirelessly transmitted to the mobile device, which can also have software installed to analyze the data. Similarly, a sensor or camera may also be mounted to the mouthpiece to detect the cleanliness or effectiveness of the rinse, and such data may be transmitted to the mobile device, which may adjust the flow control of the area accordingly. Of course, the user may adjust the flow control without sensor data, for example, the user may reduce regional flow due to sudden dental pain.

Typically, such devices are powered by use of an electrical outlet, but the device may also be powered by a battery, or in the extreme, by a hand crank.

Special accessories, such as a small brush or a flexible toothpick, may be attached to or snapped over the nozzle or the cut-out opening.

Fig. 11 illustrates a support structure design where small posts 1101 are designed to anchor the device to the tooth and also ensure clearance 1102 to the tooth surface so that liquid can flow out quickly after cleaning. The height of the posts is typically between, for example, 1 mm and 20 mm.

Fig. 12 illustrates a thin shell design, where the device is made of an enclosed volume between two thin plates 1201, where such plates are generally contoured to the tooth surface. This allows the water flow 1202 to be effectively rapid from side arch to side arch, with the support post 1203 also being placed within the housing to ensure the device has strength against biting pressure.

FIG. 13 illustrates a method in which one or more flexible material portions connect an upper portion and a lower portion, the flexible portions being insertable into a pre-designed post. This provides flexibility to accommodate occlusion changes or incorrect modeling. In this case, the upper part 1301 and the lower part 1302 are printed separately, but it is more convenient if the two parts can be placed in one insert. The insert 1303 may fit and connect the two parts, and 1303 may also be adjustable.

Fig. 14 illustrates another embodiment where a mating feature 1401 is shown, which in one example is a ball and socket design but is not limited to a ball and socket design, which mating feature is designed and attached to the upper and lower portions so that the upper and lower portions can be printed together and connected with the mating feature, which also provides some flexibility for modeling tolerances.

To keep the device clean, a pre-wash cycle may be employed prior to its use in the oral cavity, wherein the liquid may pre-wash the interior surfaces of the device before it is placed on the teeth, and the exterior surfaces, such as the buccal surfaces, may be rinsed by placing the device in a housing. Fig. 15 illustrates a housing 1501 which may have an external cleaning head 1502 which suitably cleans the equipment.

Unlike the prior art with a pre-designed template nozzle layout across the tooth surface, the incision is made through the inner housing wall, such an incision may include a thin channel through the wall, may have different internal curvatures, a narrower and curved inflow channel at the incisors, and a wider and straight channel at the posterior teeth; the interproximal and gum line areas have wider and straight channels. Such channels are complicated to make in conventional manufacturing methods, but are easier to use with 3D printing techniques.

Fig. 16A illustrates a cross-section of the inner wall of the water jet channel, which is not circular like a sprinkler, but a continuous cut (cut) through the slot along the interdental curve and gum line, with a connecting structure to support, such as a slit (crack) along the wall. The cuts may have different thicknesses and curvatures along the path. And for anterior teeth, the gap may be more curved 1602 and for posterior teeth, the gap may be relatively straighter 1603. CFD can be used to determine the pathway that, under constraints, delivers liquid quickly and efficiently from anterior (a) to posterior (P), as shown in fig. 16B and 16C. Wherein 1604, at the incisor area, the channels or slits may be angled more against the direction of flow to allow the liquid to pass quickly to the posterior teeth, and wherein 1605, the opposite being the case at the posterior teeth, the channels or slits may be angled toward the direction of liquid flow to better receive the water flow. Similarly, different heights may also be handled.

FIG. 17 illustrates a cross-section of the inner wall of the water jet channel where the movable portion 1701 may be placed. With 3D printing technology, the movable parts can be printed, which enables water to be ejected from the outlet in different patterns.

FIG. 18 illustrates a workflow: 1801, receiving the digital model, setting the appropriate orientation; the appropriate snap relationship is adjusted 1802 and the open snap relationship when the device is opened is calculated. 1803, detecting and adjusting a gum line; 1804, detecting and adjusting an interdental line or area based on the gingival line and interdental information; 1805 providing a suitable offset value, which may vary based on the tooth type and the region of interest; 1806, a single overlay internal mesh is generated, which mesh may be topologically different or re-meshed; 1807 to be more suitable for handling and storage, which is the internal (near teeth) surface mesh of the outer body of the device. The region may grow the mesh and create an outer layer of mesh, making it a water-tight closed mesh, which defines the entirety of the outer surface of the device body, and insert or deform the mesh structure to add inflow and optional outflow tubes. Also, a single mesh may be used to make future pipes and equipment easier to deform and to ensure smooth transitions between pipes and equipment.

Assuming the device maintains a certain thickness, 1808, computational fluid dynamics or simpler zone growth based on flow velocity and flow, or forward propulsion based on flow forward vectors is used to adjust our device grid surface to achieve the desired jetting properties in all zones, which can be an interactive process by constantly changing the grid and calculating the flow in the zone, calculating the error tolerance, and then readjusting the grid until all errors are within the specified tolerance. 1809, shifting the outer surface inward to generate a solid shell model, the sharp edge being reconciled. 1810, nozzle or slit opening is implemented based on zone spray angle and pressure requirements. Alternatively 1811, the movable portion may be designed to adjust the spray pattern. 1812, an outer post from the device to the tooth may be placed to anchor the device to the tooth, and an inner post placed between the two walls to strengthen the device structure. The complete grid is then output for manufacturing, most likely 3D printed.

Since the device may be used daily, sensors may be placed inside to sense various dental conditions, such as tooth decay, specific enzymes, etc.

Modifications of the above-described assemblies and methods for carrying out the invention, in combinations between the actual different variations, and variations of aspects of the invention that are obvious to a person skilled in the art are intended to be within the scope of the appended claims.