Ultrasonic dental scaler with ozonated water system

Abstract

An ultrasonic dental scaler handpiece (108) is provided with a closed system water delivery and an integrated online separate electrolytic cell (106) for generating ozone, one or more gas separators (116a, 116b), online dissolved gas monitoring using one or more UV sensors (110) and closed loop control of ozone concentration.

Description

Technical Field

[0001] The present application generally relates to a method, apparatus, computer system and computer-readable storage medium for aqueous ozone delivery, and more particularly, to a method, apparatus, computer system and computer-readable storage medium for providing aqueous ozone delivery for an ultrasonic dental scaler having a closed system. Background Art

[0002] Ozone is a highly reactive gas composed of three oxygen atoms (O3). It acts as a filter for ultraviolet light. Ozone is highly effective antimicrobial agent and has been used in medical applications including disinfection and sterilization of products. Gaseous ozone produces oxidation reactions on the cytoplasmic membrane and cell wall of bacteria. The resulting damage to the bacterial cell wall increases the accumulation of ozone inside the cell, generating free radicals that damage the bacteria.

[0003] The typical half-life of ozone is 20 minutes, which affects the concentration of aqueous ozone during transportation, filling and use. Because the efficacy of ozone decreases over time, clinicians must time ozonation and use it for each dental cleaning procedure.

[0004] Ozone can be produced by an electrolyzer. In conventional electrolyzers, the goal is to produce pure hydrogen and high pressure, so a very sturdy structure is required. This design goal means that they are not suitable for low-cost and portable devices. In addition, due to the need to avoid releasing too much gaseous ozone, the ozone content dissolved in the solution by conventional electrolyzers is usually very low. At present, there is no commercial small dental cleaning electrolyzer that can produce controlled levels of dissolved ozone at a high level. In addition, it is well known that time management is the most stressful part of a dental clinician's day. Waiting for the equipment to start and charge is unacceptable. Conventional ozonation processes that use corona discharge to produce ozone gas from compressed oxygen or room air must soak ozone in water. This can be achieved by injecting the gas directly into a distributor or venturi in a water line. An alternative system architecture that performs this gas dissolution under pressure can approach the charging rate of the electrolytic ozone generation architecture described in the present disclosure, but they are limited in their ability to produce and dissolve ozone with control and flux while maintaining a small form factor. Current methods for producing a batch of aqueous ozone are performed at or near 1 atm, requiring 20 to 30 minutes to fill a liter of water with ozone to a clinically useful concentration (e.g., 4 ppm).

[0005] In addition, the key to successful periodontal treatment and maintenance is to eliminate or reduce pathogens in the periodontal pocket and establish a microbial community that is compatible with periodontal health. The current method for periodontal debridement includes electric dental scalers and manual instruments. Modern technology for debridement mainly relies on the destruction of hard and soft deposits. Soft deposits are mainly formed by microorganisms that adhere to the surface and form a complex structure composed of microbial cells and biopolymers (i.e., EPS, extracellular polymers). When the healthy body balance changes and pathogen imbalance has been produced, dysbiosis will occur. The goal of periodontal debridement is to restore gingival health by completely removing the factors that cause gingival inflammation (i.e., plaque, calculus, endotoxins). Appropriate periodontal treatment destroys and removes subgingival biofilm, endotoxins, plaque retention factors, such as calculus. The additional goals of modern periodontal treatment are to improve patient comfort, protect tooth structure, create biologically acceptable root surfaces, and reduce inflammation.

[0006] Ultrasonic dental scalers combine acoustic energy that excites the fluid around the scaler tip to produce microflow and cavitation, while also providing mechanical debridement and continuous irrigation of the debrided surface with an irrigant. The dental scaler procedure relies on the irrigant to maintain a safe operating temperature for the scaler handpiece and tip, flush away deposits and debris, and provide a medium to couple the ultrasonic acoustic energy to the surrounding surface being cleaned.

[0007] Most ultrasonic dental cleaning procedures use potable or treated water to maintain the cleanliness of dental cleaning equipment and other water pipes. In addition, drugs can be used for periodontal debridement, and suitable drugs include chlorhexidine, provodin iodine, hydrogen peroxide, and other mouthwashes and antimicrobial agents. These drugs each have limited potency and toxicity depending on their concentration. Summary of the invention

[0008] Illustrative embodiments provide an apparatus, method, system, and computer-readable medium. In one aspect of the present invention, an ultrasonic dental cleaning device capable of generating aqueous ozone on demand is provided. It can utilize aqueous ozone irrigation to enhance the removal of dental biofilm for debridement. Aqueous ozone is delivered to the oral cavity through an ultrasonic dental cleaning machine handpiece and insert, which are controlled by the system described herein. The goal is to provide effective and safe levels of aqueous ozone to improve clinical outcomes (e.g., bleeding on probing, clinical attachment loss, periodontal tissue inflammation).

[0009] The illustrative embodiments recognize that ozone is effective in reducing the bacterial burden in the oral microbiome. This has significant benefits for oral health and broader systemic health, including reducing the risk of caries, gingivitis and periodontitis, bad breath, cardiovascular disease, stroke, hyperglycemia, and other diseases.

[0010] The illustrative embodiments also recognize that an ultrasonic scaler with the ability to generate and control aqueous ozone delivery solves a key market barrier. Practices do not need to purchase a separate ozone generator in addition to the ultrasonic scaler unit. Practices do not need to ozonate water, transport, and fill the ultrasonic scaler reservoir.

[0011] In one aspect of the present invention, a method of providing ozonated water to an ultrasonic scaler handpiece is disclosed. The method includes: delivering water from a water source to an electrolytic cell of an aqueous ozone ultrasonic scaler system; delivering an electric current to the electrolytic cell to generate ozone gas in the water; providing one or more recirculation loops in a fluid pathway to move water and ozone gas through the electrolytic cell and one or more gas separators corresponding to the one or more recirculation loops; controlling the ozone gas concentration level in the water by the amount of electric current delivered to the electrolytic cell to generate ozone water with a defined dissolved ozone concentration; and separating gaseous ozone from the ozonated water stream to be delivered to the handpiece using one or more gas separators.

[0012] In another aspect disclosed herein, the method includes any combination of the following: (i) further including providing one or more pumps to maintain a defined fluid level and pressure of the aqueous ozone ultrasonic scaler system to increase the solubility of the ozone gas in the water, (ii) further including: in response to providing two or more recirculation loops, after a defined operating period and after verifying that the ozone gas in the water has decayed, switching the electrical polarity of the electrolytic cell so that the side of the aqueous ozone ultrasonic scaler system that was the cathode side in the previous operation becomes the anode side in the current operation, and the other side of the aqueous ozone ultrasonic scaler system that was the anode side in the previous operation becomes the cathode side in the current operation, so as to distribute membrane degradation caused by the interaction of the ozone gas and other oxidizing species from the electrolytic cell on both sides of the electrolytic cell. , to extend the shelf life of the membrane of the electrolytic cell (one or more membranes may be used. Each membrane is mechanically interlocked with the electrode, so two membranes are used to decouple the electrodes to prevent the membrane from being subjected to high mechanical shear stress. In illustrative embodiments, three or four or more membranes may be stacked), (iii) wherein the switching eliminates or substantially eliminates stagnant water and microbial contamination, (iv) wherein the water delivered from the water source is deionized water or water obtained from reverse osmosis (low conductivity water concentrates current density at the three-phase boundary, improves ozone generation and prevents scaling of mineral deposits on the electrodes), (v) also includes: using an inlet baffle to slow down the flow of ozonated water entering one or more gas separators, so that the overturning flow in the chamber of the one or more gas separators is substantially reduced and bubbles are prevented from being carried to the outlet port of the one or more gas separators. This also prevents bubbles from entering the recirculation loop, eliminating bubble interference with the optical UV absorption ozone sensor.

[0013] In another aspect of the present invention, an apparatus for providing ozonated water to an ultrasonic scaler handpiece is disclosed. The apparatus includes: a water source for delivering water to an electrolytic cell of an aqueous ozone ultrasonic scaler, the electrolytic cell being connected to the water source by a fluid pathway and adapted to receive an electric current to generate ozone gas in the water to form the ozonated water; one or more gas separators, each gas separator being disposed in a corresponding recirculation loop of the fluid pathway also containing the electrolytic cell, each gas separator being configured to separate gaseous ozone from a flow of ozonated water to be delivered to the handpiece; and one or more ultraviolet sensors disposed in the recirculation loop of the fluid pathway, the one or more ultraviolet sensors being adapted to measure the concentration of dissolved ozone in the water by an amount of ultraviolet light passing through the water absorbed by a portion of the water.

[0014] On the other hand, one or more combinations of the following features of the device are disclosed: (i) also including: one or more pumps, deployed in the fluid pathway to control the pressure of the device in at least a portion of the fluid pathway, (ii) also including: one or more valves, deployed in the fluid pathway to release gas to control another pressure of the device in at least a portion of the fluid pathway, (iii) also including: one or more level sensors, connected to one or more gas separators to measure the level of ozonated water in the gas separators, (iv) also including: an ozone destructor, deployed in the gas release pathway of one or more gas separators and suitable for converting separated gaseous ozone gas into oxygen, (v) wherein the water source is a spray bag or water bottle having a duckbill connection assembly to deliver water in a single direction, (vi) wherein the water source is maintained in a loading tray in the base of the device, and (vii) wherein the polarity of the electrolytic ozone cell is switchable to reverse the side of the device that produces ozone gas.

[0015] In another aspect, a computer system for providing ozonated water to an ultrasonic scaler handpiece is disclosed. The computer system includes a processor configured to perform the following steps: delivering water from a water source to an electrolytic cell of an aqueous ozone ultrasonic scaler system; delivering an electric current to the electrolytic cell to generate ozone gas in the water; providing one or more recirculation loops in a fluid pathway to move water and ozone gas through the electrolytic cell and one or more gas separators corresponding to the one or more recirculation loops; controlling the ozone gas concentration level in the water by the amount of electric current delivered to the electrolytic cell to generate ozone water having a defined concentration of dissolved ozone; and separating gaseous ozone from the ozonated water stream to be delivered to the handpiece using the one or more gas separators.

[0016] In yet another aspect, a non-transitory computer-readable storage medium storing a program is disclosed, which, when executed by a computer system, causes the computer system to execute a procedure, the procedure comprising: delivering water from a water source to an electrolytic cell of an aqueous ozone ultrasonic dental scaler system; delivering an electric current to the electrolytic cell to generate ozone gas in the water; providing one or more recirculation loops in a fluid pathway to move water and ozone gas through the electrolytic cell and one or more gas separators corresponding to the one or more recirculation loops; controlling the level of ozone gas concentration in the water by the amount of electric current delivered to the electrolytic cell to produce ozone water having a defined concentration of dissolved ozone measured via ozone absorption characteristics of ultraviolet light; and separating gaseous ozone from the ozonated water stream to be delivered to a handpiece using one or more gas separators.

[0017] A fully integrated system with online aqueous ozone generation enables the generation and use of aqueous ozone in the operating room when the procedure requires it. The materials used in the fluid passages / fluid paths of the aqueous ozone generator and scaler are controlled and engineered to limit scavenging and ensure compatibility of the materials with dissolved ozone, control the concentration of the irrigant leaving the scaler machine, and ensure reliability and efficacy of the equipment. The development and integration of the ozone generator and ultrasonic scaler prevents the misuse of aqueous ozone in existing scalers that are incompatible with ozone.

[0018] In one aspect of the present invention, dental professionals are able to use an ultrasonic dental cleaning unit with or without the generation of aqueous ozone. Being able to turn off or reduce the ozone to only maintain waterline cleanliness provides clinicians with the ability to manage when they deliver aqueous ozone to their patients.

[0019] To produce aqueous ozone and obtain the associated clinical benefits, specially formulated water other than municipal water may be required. Different levels of flora and other forms of water other than the specially formulated water may contain chemicals and / or additives. For example, specially formulated water may be contained in 1 / 2 liter bottles corresponding to, for example, 2 to 4 patients. The water is delivered in a container with a proprietary fitting designed to interface with the scaler water and prevent refilling. By controlling the input water, system reliability and irrigation quality and efficacy can be controlled.

[0020] In an illustrative embodiment, by combining the efficacy of ultrasonic dental cleaning with the antibacterial and anti-biofilm properties of aqueous ozone, the system significantly improves periodontal clinical parameters (e.g., bleeding on probing (BOP), clinical attachment loss, etc.) compared to conventional debridement methods. When pathogenic flora is more thoroughly removed, it is more likely to recolonize clean pockets with more benign flora. The goal of ongoing periodontal therapy is to achieve a transition from pathogenic (non-biological) flora to more benign populations of persistent microorganisms that are less harmful to local tissues and can maintain a reasonable balance with host tissues and physiology in these areas. The result is a reduction in inflammation of periodontal tissues, thereby helping to improve clinical parameters of patients receiving treatment for gingivitis and periodontal disease more than any other debridement method. Aqueous ozone combined with the mode of action of an ultrasonic dental scaler (i.e., mechanical, cavitation, micro-flow and irrigation) can eradicate pathogens, thereby slowing down the formation of non-biological pathogenic subgingival biofilm and plaque better than any other debridement method. The consequences can include significant improvements in oral freshness, reduction in gingival inflammation, and long-term retention of teeth. By cleaning teeth with aqueous ozone, ozone reduces infectious aerosols from patient bacteria present in the oral cavity during ultrasonic cleaning. Since the system is not exposed to tap water and all fluids in the system will be ozonated, the formation of biofilm in the system pipes and waterways is inhibited, and the waterline of the ultrasonic cleaning system can be kept nearly sterile, i.e., less than 100 colony forming units (CFU), and may be as low as 5 CFU when performing clinical procedures (e.g., cleaning teeth, SRP). Although antimicrobial agents (e.g., chlorhexidine, hydrogen peroxide, sodium hypochlorite, provitamin iodine) currently exist, and the system can be used to deliver them to ultrasonic scaler irrigation, the ozone and oxygen-infused water produced by the system to eliminate pathogens is natural and does not contain additives or chemicals. Aqueous ozone decomposes so quickly, decomposing into water and oxygen, it does not remain active in the periodontal pocket and has lower cytotoxicity than other antimicrobial agents. It has no effect on taste and does not cause staining. By combining the main modes of action of ultrasonic scalers (e.g., mechanical, acoustic microflow, cavitation, and irrigation) with aqueous ozone, hard and soft deposits can be removed without adding any additional steps or adjunctive treatments. The combined technology eradicates pathogens and disrupts subgingival biofilm without the need for additional treatments (e.g., adjunctive medications, manual instruments, subgingival air polishing, etc.).

[0021] Thus, the illustrative embodiments recognize that aqueous ozone (AO) is an advantageous option for delivering antimicrobial functionality in irrigation, replacing the need for conventional antimicrobial additives. Ozone in solution is a broad-spectrum antimicrobial agent, capable of inactivating bacteria, fungi and viruses, and does not develop drug resistance. In addition, aqueous ozone accelerates the removal of biofilms, shortens tooth cleaning procedures or improves the integrity of biofilm removal. The chemical action of aqueous ozone on biofilms expands the effective radius of action of tooth cleaning and also attacks physically inaccessible biofilms. Aqueous ozone is very effective in degrading biofilms and killing microbial cells, but has low toxicity to patient tissues, as described in the publication entitled "Effect of ozone onoral cells compared with established antimicrobials" by Karin C. Huth et al., Eur J Oral Sci. 2006: Vol. 114:, pp435-440, the entire contents of which are incorporated herein by reference as if fully set forth herein.

[0022] The use of aqueous ozone irrigation can allow for reduced ultrasonic power but with the same cleaning efficacy, thereby reducing patient discomfort. Optimizing the results of aqueous ozone scaling methods requires joint control of parameters, so an integrated scaler with ozone generation and delivery means is highly preferred. This system provides all the necessary means to provide an optimized safe and effective ozone enhanced scaling treatment. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] To facilitate identification of the discussion of any particular element or act, the most significant digit in a reference number refers to the figure number in which the element is first introduced. Certain novel features believed to be characteristic of the invention are set forth in the appended claims. However, the invention itself and its preferred mode of use, further objects and advantages thereof will be best understood by reference to the following detailed description of illustrative embodiments read in conjunction with the accompanying drawings, in which:

[0024] Figure 1 A block diagram of a system according to one embodiment is depicted.

[0025] Figure 2 Depicted is a schematic diagram of an electrolytic cell according to one embodiment.

[0026] Figure 3A A perspective view depicting an electrolytic cell according to one embodiment

[0027] Figure 3B Depicted is a perspective view of an electrolytic cell according to one embodiment.

[0028] Figure 4 A block diagram of a system according to one embodiment is depicted.

[0029] Figure 5 A diagram is depicted according to one embodiment.

[0030] Fig. 6A Depicted is a perspective view of an ultraviolet (UV) sensor according to one embodiment.

[0031] Figure 6B A cross-sectional view of an ultraviolet (UV) sensor according to another embodiment is illustrated.

[0032] Figure 6C A perspective view of an ultraviolet (UV) sensor according to another embodiment is illustrated.

[0033] Figure 7 A schematic diagram of a connection according to one embodiment is depicted.

[0034] Figure 8 A schematic diagram of a bag and connections according to one embodiment is depicted.

[0035] Fig. 9 An interaction according to one embodiment is depicted.

[0036] Fig.10 A schematic diagram of a connection according to one embodiment is depicted.

[0037] Fig.11 A schematic diagram of a connection according to one embodiment is depicted.

[0038] Fig.12 A schematic diagram of a connection according to one embodiment is depicted.

[0039] Fig.13A Flow patterns according to one embodiment are depicted.

[0040] Fig. 13B Flow patterns according to one embodiment are depicted.

[0041] Fig. 13C Flow patterns according to one embodiment are depicted.

[0042] Fig.14 A system according to one embodiment is depicted.

[0043] Fig.15 A system according to one embodiment is depicted.

[0044] Fig.16 A system according to one embodiment is depicted.

[0045] Fig.17A An alternative configuration of a system according to one embodiment is depicted.

[0046] Fig. 17BAn alternative configuration of a system according to one embodiment is depicted.

[0047] Fig. 17C An alternative configuration of a system according to one embodiment is depicted.

[0048] Fig.17D An alternative configuration of a system according to one embodiment is depicted.

[0049] Fig.18A An alternative configuration of a system according to one embodiment is depicted.

[0050] Fig.18B An alternative configuration of a system according to one embodiment is depicted.

[0051] Fig. 18C An alternative configuration of a system according to one embodiment is depicted.

[0052] Fig.19A An alternative configuration of a system according to one embodiment is depicted.

[0053] Fig. 20B An alternative configuration of a system according to one embodiment is described.

[0054] Fig. 20A An alternative configuration of a system according to one embodiment is depicted.

[0055] Fig. 20B An alternative configuration of a system according to one embodiment is depicted.

[0056] Fig.21 is a flow chart illustrating a method according to one embodiment.

[0057] Fig. 22 A computer system according to one embodiment is illustrated. DETAILED DESCRIPTION

[0058] The illustrative embodiments described herein relate to an ultrasonic dental scaler with aqueous ozone. The ultrasonic dental scaler includes a water source, an electrolytic cell, a gas separator, an ozone destroyer, a pump, and a handpiece, which are described below.

[0059] Systems and devices

[0060] Figure 1A block diagram of an aqueous ozone ultrasonic dental scaler system 100 according to one embodiment is depicted. The system includes a water source 104 suitable for enabling safe, long-term operation of the system. In an illustrative embodiment, the water source is purified water, such as deionized water or water obtained from reverse osmosis, particularly with negligible levels of multivalent metal ions. Optional water compositions containing selected concentrations of dissolved carbon dioxide or oxygen or inert gases can be used in the proposed system. The water source 104 can be delivered in a package / water bottle / spray bag 704, such as a package of 200 to 1000 ml, with accessories to protect the system from the supply of water that may contaminate the pool or produce unwanted components (e.g., bromine to bromide or chlorate) when ozonated. The aqueous ozone ultrasonic dental scaler system 100 has one, two or more water sources 104 attached. The system has the ability to automatically switch from one water source 104 to another water source 104 when the water source 104 (spray bag 704) becomes empty during the procedure, thereby preventing the clinician from being interrupted when treating the patient. Before starting the second procedure, the system will remind the clinician that the package is empty and needs to be replaced. The water source 104 has a fitting that prevents refilling. In the illustrative embodiment, the system identifies whether the package has been refilled by looking for a connection force or reading an RFID tag that prevents reuse and use of an alternative water source.

[0061] The aqueous ozone ultrasonic scaler system 100 also includes an electrolytic ozone tank 106, which oxidizes water to form ozone in solution. Conventional tanks also produce some oxygen as a byproduct, which further increases the utility of the produced water for treatment against anaerobic organisms, but in any case, does not reduce the value of the aqueous ozone (AO) solution for the main purpose of cleaning teeth. The pool may also produce some hydrogen peroxide, and this component of the solution is also conducive to cleaning, bleaching and antibacterial effects. In some cases, the synergistic effect of ozone and hydrogen peroxide is known and can be used advantageously by the system.

[0062] The system is able to more quickly change the ozone level in the system at startup by driving the electrolytic ozone cell 106 at a higher current than is required to maintain the proper level during run time and idle time. During startup, the system reaches a defined pressure by two means—the main water pump 118c that fills and pressurizes the system with water, and the air pump 118a (or air pump 118b) that assists the main water pump 118c on the gas side of the system to generate sufficient system operating pressure required to drive fluid to the scaler handpiece.

[0063] In the illustrative embodiment, the monitoring and control equipment enables the generation of a stable and known concentration of active species under the control of the user. Ozone is a strong oxidant, and the system should be able to automatically monitor and control the concentration generated to ensure safety and efficacy.

[0064] Gas separators 116a, 116b separate gaseous ozone from the water flow delivered to the ultrasonic handpiece 108. Gaseous ozone is irritating and does not usefully increase the efficacy of tooth cleaning, so the aqueous ozone ultrasonic scaler system 100 is suitable for providing all ozone to the instrument in the form of a solution, and with minimal bubbles. The system also includes a means to ensure that the flow path within the system is sufficiently free of bubbles to enable components such as ozone sensors or pumps to operate. Similarly, the system includes a means for separating gaseous hydrogen to be removed from the cathode, which avoids the need for a hydrogen peroxide waste stream from a depolarized cathode. The system is suitable for optimizing the flow conditions in the electrolytic ozone cell 106 separately from the flow requirements of the clinician. For example, the buffer volume in the gas separator is used to decouple the instantaneous flow in the cell from the flow rate delivered. The use of the buffer volume 134 and the recirculation loop 132 allows the internal flow rate to be higher than the net flow from the inlet to the outlet, thereby allowing the flow rate to be independently changed as required. In practice, this has the additional advantage of providing a well-mixed system volume for accurate concentration measurement and controlled delivery to the ultrasonic handpiece 108, and it also enables integration of the gas separator 116a, gas separator 116b and the in-line sensor 102 with a faster response time than in a stagnant storage volume.

[0065] In addition, the system includes means for controlling the flow and ozone content of water flowing to the handpiece in response to user controls and setting preferences, combined with meeting other requirements, such as cooling or coupling ultrasound to the target surface. The present disclosure contemplates dynamically controlled water flow and ozone levels in response to use and instrument parameters (such as power level). (For example, as inferred from ultrasonic parameters, if the tip is not in contact with the target surface, the excitation power can be temporarily reduced and the water flow will also be reduced. When "active" tooth cleaning occurs, the control system can immediately increase the power and water flow. Adaptive behavior can provide significant usability advantages for the system and can reduce the need to operate manual controls. In addition, the system considers controlling the system operating pressure to operate the system at an elevated pressure to dissolve more ozone in the generation circuit and provide water at a pressure sufficient to operate a standard tooth cleaning machine, thereby allowing the use of existing equipment. In addition, the pressure can be controlled to provide a pressure signal that can be used as part of a flow control method, such as when filling the system, and for controlling the discharge of gas produced by electrolysis. In another embodiment, the system can be adjusted to operate at one of a plurality of different pressure settings, and the electrolytic cell operating point can be adjusted to compensate for the amount of gas dissolved at different pressures.

[0066] The ozone destroyer 114 also serves to neutralize any unwanted ozone that would otherwise be released by the system, for example, as part of the gas separation function. In addition, a means of managing any associated hydrogen released from the cathode of the electrolytic cell. The hydrogen can be oxidized back into water in the cell itself or in a separate component optimized for this function, or in conjunction with the reduction of excess ozone. The ultrasonic handpiece 108 is adapted to function with increased efficacy in the case of ozone-enriched irrigation. For example, adjustments may include a coating that increases the compatibility of the handpiece with ozone solutions, an ultrasonic exciter with low heat output, a sensing device connected to the drive unit, a recirculating water flow option, or a dual flow design using ordinary water flow for cooling and basic irrigation and on-demand use of ozonated irrigation delivered directly to the tip only.

[0067] In addition, the system includes a user interface 402, a physical interface to a water source (not shown) and a handpiece, and an appropriate cabinet to best suit the system to the needs of the dentist and the safety and efficacy of the relevant procedures. In the initial embodiment, the system functions very similarly to a conventional non-ozonated ultrasonic scaler, allowing a skilled user to immediately use the new system in an established procedure. The control of the integrated ultrasonic and ozone generation functions is a valuable feature of the proposed embodiment.

[0068] The system is inherently safe and has several properties that provide safety and efficacy by design. The system therefore delivers aqueous ozone, and no ozone in gaseous form is delivered to the patient. The flow rate of aqueous ozone is limited by the system low pressure, flow control, and orifices in the ultrasonic scaler plug-in. Ozone production is inherently safe and is controlled by Faraday's law of electrolysis, and gas production is proportional to the current. Therefore, the electrolytic ozone (EO) produced is directly limited by the DC current sent to the EO generator. The presence of water in the system is necessary for the electrolytic generator to produce aqueous ozone, and the ozone generator 122 can be configured not to operate or produce ozone gas in the absence of water. The UV sensor 110 directly monitors the ozone level in the water. Faraday control establishes a safe operating area so that the pool drive parameters can provide control and monitoring of the pool conditions, because the current and the resulting pool voltage are the factors that drive the electrochemical reaction. The system ozonates high-purity water delivered in a custom container with a proprietary connection, thereby providing control over the input water quality and the components found in the ozonated lavage. Unlike other systems that attempt to ozonate tap water or dissolve gases produced by indoor air via corona discharge. The safety of irrigation is controlled by the input water, ozone-compatible materials used to build the system, and a gas separator that prevents gas and entrained gas from being delivered to the ultrasonic scaler handpiece. Excess ozone gas is converted into oxygen (O2) via an ozone destroyer and neutralized, thereby preventing ozone from being intentionally released into the local environment through the gas release passage 146. Strong pipes, joints, and components (i.e., pumps and valves) prevent unwanted ozone emissions (i.e., leaks) in the system. If the system state is not ready to provide irrigation (i.e., empty fresh water source, target ozone level not reached, system pressure not reached, or fault detected), the system control will prevent ultrasonic operation.

[0069] Having briefly described the components of the aqueous ozone ultrasonic scaler system 100, the components will now be described in greater detail.

[0070] In the illustrative embodiment, the water source 104 is pre-formulated in a separate package, as shown in Figures 17-19. The package is sterile and has a suitable sterile connection to the system (not shown). To ensure continuity of supply during the procedure, the system is adapted to allow multiple containers, such as two containers, and to switch between them if the first container empties during treatment. In the illustrative embodiment, the system determines that the correct water package has been inserted to ensure safe and optimal operation of the system.

[0071] In such Fig.15In another illustrative embodiment shown in, real-time purified water from a drinking water source is incorporated. In this article, a separate purifier supply or an integrated purifier is used to purify tap water 1504. The purifier supply system includes a water quality sensor to ensure the correct operation of the electrolytic cell safety supply. In the case of using an external purifier, a small secondary purification stage can be included, and its specific function is to remove any residual ion traces known to have a high affinity for the membrane, such as Fe, Cu, Zn or Al, and also promote the membrane degradation process. In particular, the integrated water purification mechanism can use conventional reverse osmosis / deionization technology, or preferably, use self-regeneration deionization technology, such as electrodeionization, which can use standard drinking water supply / non-ozonated water and produce enough flux of purified water for the average usage rate of the system. Intermediate water storage can be used to achieve the buffer between peak demand and average demand, at the cost of making the system take up more space. Tap water 1504 is usually available at a limited pressure, and this pressure can be used to drive the initial filtration step in the purification process, thereby reducing the need to include a separate pump in the system only for this purpose. In addition to the bottle supply configuration, the system is also adapted to allow operation using a plumbed-in water source to allow the operator to select non-ozonating operation at any time and avoid exhaustion of the pure water supply when it is not actually needed. Unless the plumbed supply is filtered and deionized, it is preferably not used in the electrolytic ozone generator. The plumbed water source will not pass through the ozone generator 122 part of the system, but will be delivered through a bypass water pipe, which controls the water pressure and a separate water solenoid to enable and disable water output to the handpiece. The system can also be designed without an external connection for plumbed water; however, it may still be equipped with a bypass line that draws water from the bottle supply configuration and delivers it directly to the handpiece without ozone. Non-ozonating operation can also be performed by shutting off the current of the electrolytic ozone cell 106 through the ozone generator 122 part of the system, and the cell current can also be operated at a significantly lower level or pulsed infrequently with the current required to produce ozone, so as to provide undetectable ozone levels to maintain the cleanliness of the water pipes in the system.

[0072] Figure 2 A schematic diagram of an electrolytic cell according to one embodiment is depicted. Electrochemical ozone generation by direct oxidation of water instead of forming O3 from O2 in the gas phase is a complex electrochemical process in which the catalytic electrode surface is the site of a network of reactions via several different adsorbed intermediates. The reaction network produces a mixture of oxygen and ozone. The chemistry of the catalyst surface affects the proportion of ozone production, but the oxygen formation pathway is energetically more favorable, and typically at least half of the electrode current forms oxygen even on the most ozone-promoting surfaces.

[0073] The goal is to achieve as high an oxygen evolution (and thus hydrogen production) rate as possible at the lowest achievable cell voltage, because this directly affects the energy cost of the process. Most electrolysis is carried out directly, with a conductive electrolyte transmitting current between electrodes, but membrane 202 (proton conducting membrane) can be used to transmit proton current, but does not allow other substances to pass through at an appreciable rate. This allows the electrolysis of pure water to be achieved, with significant advantages in chemical simplicity and the absence of unwanted by-products. Membrane 202 can be a sulfonated derivative of Teflon, such as Nafion, Aquivion and similar products. These cells are generally referred to as proton exchange membrane water electrolyzers (PEMWE). For example, PEMWE industrial cells in the so-called "Membrel" process for oxygen / hydrogen production can have a long working life. However, when the cell voltage is increased and an ozone selective catalyst is used, the achievable working life is significantly reduced due to the degradation of membranes and electrodes in extreme oxidizing environments, particularly due to some free radical-mediated reactions that effectively attack membrane polymers.

[0074] The selective formation of ozone instead of oxygen has hydrogen as a waste. Since the goal of the aqueous ozone ultrasonic scaler system 100 is to achieve a combination of high dissolved ozone concentration and long working life of the pool, electrodes of boron-doped diamond (BDD) can be used to take advantage of the preferential ozone and oxygen formation ratio of this material. However, BDD as a material has some practical challenges because it is essentially equivalent to diamond in terms of mechanical properties and a controllable conductive layer must be formed by directly synthesizing a doped diamond layer on a suitable substrate. Therefore, the BDD electrode is a relatively expensive and fragile component. In an illustrative embodiment, the electrolytic ozone cell 106 includes a pair of perforated silicon plates with a thin boron-doped diamond coating, between which there is a proton conductive membrane 202, and a flow channel 204 for water and released gas to pass through the perforated surface. This configuration provides the necessary three-phase boundary area at the edge of each hole in the plate. Of course, other similar arrangements can also be obtained according to this specification. The examples in this disclosure are only for clarity of description and do not limit the illustrative embodiments. Additional operations, actions, tasks, activities, and manipulations will be apparent from the present disclosure and are considered to be within the scope of the illustrative embodiments.

[0075] Figure 3A A perspective view of a first configuration of the electrolytic ozone cell 106 is depicted, in accordance with one embodiment. In this configuration, the flow channel 204 is arranged parallel to the membrane 202.

[0076] Figure 3B A perspective view of another configuration of the electrolytic ozone cell 106 is depicted, wherein the flow channels 204 are arranged perpendicular to the membrane 202, according to one embodiment.

[0077] Figure 4A block diagram depicts the interactions 400 between components of the aqueous ozone ultrasonic scaler system 100 according to one embodiment. The interactions 400 include communication between the electrolytic ozone cell 106, ultrasonic handpiece 108, uv sensor 110, solenoid 128, foot pedal 130, user interface 402, ultrasonic control board 404, ozone system main control board 406, power supply 408, sensor 410, and pump 412. Figure 1 The components of all the aqueous ozone ultrasonic dental scaler system 100 are part of the ultrasonic control board 404 and the ozone system main control board 406. The ultrasonic control board 404 and the ozone system main control board 406 are included in or form one or more control units for controlling the interaction 400 in the aqueous ozone ultrasonic dental scaler system 100.

[0078] Fig. 6A A perspective view of a UV sensor 110 is depicted according to one embodiment.

[0079] The UV sensor 110 includes an LED with a temperature sensor 602; a bracket 604 that allows a lens to be added; a cover 606 that holds mounting points for the optical and electronic components to allow easy removal and maintenance; the cover provides heat dissipation, allows a monitoring photodiode (off-axis) 608 with a temperature sensor to compensate for LED output / intensity that varies over time; and a stepped window 610 made of sapphire to allow light transmission, chemical resistance, and mechanical toughness with minimal flow gaps. The UV sensor 110 also has a temperature sensor hole 612 for allowing thermal expansion when necessary; an anodized aluminum tube 614, for example, externally threaded and screwed in to provide pressure on the window holding optical components and printed circuit board (PCB); a measuring photodiode (on axis) 616 (detector) with a temperature sensor to allow compensation for changes in photodiode (PD) sensitivity with temperature; a routing grommet 618; a Kynar polyvinylidene fluoride (PVDF) block manifold 620 for ensuring accuracy of the optical path and ease of integration; and an input kynar barb fitting 622 for receiving water whose ozone level is to be measured and output through an output kynar barb fitting 624.

[0080] To maintain safety and efficacy, the water-based ozone ultrasonic scaler system 100 is configured to directly measure ozone in water by measuring the absorbance of ultraviolet light. The UV sensor 110 operates on the principle of light absorption and utilizes an ultraviolet light emitting diode (UV LED). Figure 5 As shown in , ozone strongly absorbs light in the ultraviolet region around 280nm. A 280nm LED may be chosen because it is cheaper than a 260nm LED (260nm is where the absorption peak is located) and is still absorbed enough to be detected. Of course, the choice is not limited to a 280nm LED.

[0081] Ozone absorption spectrum Figure 5 . The sensor for measuring dissolved ozone exploits this phenomenon. The principle is the absorption of light by ozone. For example, the more ozone is produced, the lower the UV signal detected. The light reaching the measuring photodiode (on-axis) 616 is mathematically described by the Beer-Lambert law, which relates the attenuation of light to the properties of the material through which the light propagates.

[0082] V=V o [T led ].loss.e -σ[λ].x[T].concentration

[0083] The light projected through the water column is expressed as a voltage V at the output of the detector amplifier (measurement photodiode (on-axis) 616). o is the voltage from the detector when nothing is absorbing or scattering the light. This depends on the LED temperature T ledVarying LED brightness. The system will continuously monitor two parameters, the output of the LED and the temperature of the LED. σ[λ] is the absorption cross section (in units of area). V is the signal voltage representing the detected light. The detector voltage depends on its temperature, so the UV sensor 110 is able to measure and compensate for temperature effects. Its value depends on the LED wavelength λ, which in turn changes with temperature. This variation is predictable and can be compensated for using additional circuitry and software. x[λ] is the distance the light travels through the water containing the dissolved ozone. This is the path length. The path length / absorption cross section has the potential to change due to temperature changes caused by material expansion. This variation is minimized by material selection and any drift is compensated or simply accepted. These values ​​can vary from unit to unit and can therefore be corrected by using a calibration method as part of the final test procedure in manufacturing, which can be done using a known "concentration" of dissolved ozone to provide the value of the combined constant (-σ.x). This value is called the "calibration constant". The system is able to correct this constant for changes caused by temperature by understanding how it changes with temperature and adjusting it for the ambient temperature during operation. The loss is caused by window contamination or anything that obstructs the light. This can be evaluated as a more frequent zero test when there is pure water in the flow path x. It is assumed that there are no significant absorbers at this wavelength, and experiments have shown that, for example, peroxide has a negligible effect at this wavelength. During system startup, for example, for each day, the cathode electrolyte from the previous day is circulated through the UV sensor, the cathode electrolyte will be free of ozone and provide a reference fluid to eliminate any errors associated with the optical path (i.e., residues, reflections, and surface buildup that absorbs photons that offset the ozone measurement). To reduce LED heating and eliminate "dark current", the LED is pulsed and measurements are taken in both the "on" and "off" states. For example, the pulses last approximately 3ms "on" and 3ms "off", and they can be as short as, for example, 200 microseconds and as long as 10 seconds. The timing is controlled by software, but additional circuit elements can provide hardware-based pulsing with picosecond repeatability and accuracy. Each flash's "on" value has a corresponding "off" value subtracted from it (thereby allowing transient lighting changes to be smoothed out), and the resulting value averaged over 100 flashes, or as few as 10 or over 100,000 flashes.

[0084] The use of light is a non-contact method of measuring dissolved ozone and avoids the introduction of contaminants in the water pipes that would be associated with electrolytic ozone sensors that must contact the water.

[0085] Figure 6BA uv sensor 110 according to another illustrative embodiment is shown. The uv sensor 110 can be configured with a housing that allows it to be compatible with a manifold (not shown) of an aqueous ozone ultrasonic dental scaler system 100. A plurality of manifold mounting points 642 allow the sensor to be attached to the manifold. The uv sensor 110 includes a monitoring photodiode (off-axis) 608 to monitor the intensity of light projected by the UVLED 626. The measuring photodiode (on-axis) 616 located on the projection axis is configured to measure the amount of returned uv light, which indicates the ozone concentration in the water passing through the water column 634 from the fluid port 636. The collimating lens 628 collimates the uv light toward the measuring photodiode (on-axis) 616. The measuring photodiode (on-axis) 616 is coupled to the housing 640 and connected to the flexible circuit 630 so that the movement of the flexible circuit 630 during, for example, manufacturing does not displace the measuring photodiode (on-axis) 616 from the axis. The flexible circuit ideally has on-board electrical connections 638 that allow power, analog signals, temperature, and digital communication lines to be brought from the external / host control circuitry to the UV sensor 110 to allow local measurement and calculations, thereby preventing or substantially eliminating noise that would otherwise be generated in a sensor that does not have local measurement and local calculation capabilities.

[0086] In another illustrative embodiment, Figure 6C As shown in , a plurality of uv sensors 110 are combined in a plurality of configurations, each sensor being configured to be used during a corresponding switch configuration of the electrolytic ozone cell 106, for example, one uv sensor 110 can be used during an anode / cathode configuration, and a different uv sensor 110 can be used when the configuration is switched to a cathode / anode configuration by a polarity reversal of the electrolytic ozone cell 106. The rigid PCB 644 can be a sub-portion of the flexible circuit 630.

[0087] Integrating an aqueous ozone generator with closed loop control of ozone concentration into an ultrasonic scaler requires reduction of key components and integration into the fluid manifold. The UV sensor 110 for monitoring ozone concentration is a key component required on both sides of the system (cathodic and anodic) to support daily polarity switching. Two small sensors or a single sensor with two channels are required. Alternative approaches include diverting the recirculating water loop past the sensor using 4 three-way valves that will switch depending on which side of the system is producing ozone.

[0088] Since ozone is produced in an electrolytic cell, its production can be increased or decreased based on the level of DC current flowing into the cell. The information provided by the UV sensor provides the control loop with a measurement of the ozone concentration in the water recirculating in the system. From the cell, the aqueous ozone passes into a gas separator, and from the gas separator into the UV sensor. The gas separator ensures that the water flowing through the UV sensor is free of bubbles, which would block the light in the UV sensor and thus create noise in the measurement. Static bubbles that form within the fluid path when the system is shut down must be flushed out of the UV sensor. In order to obtain a clear water column, the fluid passage through the system is designed to avoid Eddie flows and voids, which would reduce flow velocity and prevent bubbles from being carried away in the flowing stream.

[0089] The manifold-compatible UV sensor has two fluid ports that connect to the manifold during assembly of the UV sensor to the manifold. The interface seal between the UV sensor body and the manifold forms the fluid connection. Water flows out of the manifold, into the UV sensor, and then out of the UV sensor and into the manifold. The fluid path is oriented to avoid bubble entrapment, so the UV sensor is preferably positioned on the bottom of the manifold so that gravity can aid in flushing of bubbles. The sapphire windows at each end of the water column must be exposed to the fluid flow so that the water flow through the sensor easily removes bubbles and debris. Mounting the sensor to the bottom of the manifold makes it easier to support integration into an ultrasonic dental scaler by designing the sensor to be low profile, which supports the need to minimize the height of the dental scaler, which is a requirement for installation in a dental operating room.

[0090] The manifold-compatible UV sensor 110 can be designed to be easy to assemble. The sensor provides a sealed fluid path that can transmit ultraviolet light through a water column 634. At both ends of the water column 634 are electro-optical components arranged to optimize the signal-to-noise ratio. Mounting the UV LED 626 and the measurement photodiode (on-axis) 616 on a flexible circuit 630 mechanically separates these electro-optical components from any rigid PCBs that integrate all the electronic devices for controlling the LED, powering the photodiode, amplifying, digitizing, and analyzing the analog photodiode signal. The sensor circuit includes a microprocessor for processing an algorithm that uses the analog voltage from the detector photodiode and the monitoring photodiode as well as calibration and loss values ​​to calculate the ozone concentration. By maintaining a local microprocessor, the ozone concentration can be digitally transmitted to a central microprocessor responsible for controlling the entire aqueous ozone system, ultrasonic dental scaler, and user interface via, for example, an I2C bus. Processing analog signals near the photodiode can reduce the possibility of electrical noise coupling because the analog signal lines can be kept short and shielded from external noise sources (e.g., pump motors, solenoids, power supplies, DC regulators, touch screen electronics). The UV sensor 110, which is designed to fully integrate analog signal processing, analog-to-digital conversion, calculation, and digitization of ozone concentration, also simplifies factory calibration routines. The UV sensor 110 can be calibrated and inventoried as a complete module. The ultrasonic dental scaler provides DC power and I2C bus connection to access sensor information. The sensor can provide serialization information, ozone concentration, sensor health diagnostic information related to loss information, temperature values ​​of the UV LED 626 and photodiode, as well as firmware version and calibration details. This module approach directly supports product service because once the sensor is installed in the aqueous ozone ultrasonic dental scaler 706, it can be replaced without calibration.

[0091] Back to Figure 1 , gas separator 116a and gas separator 116b will now be further described. In the aqueous ozone ultrasonic scaler system 100, there is a gas headspace that is in equilibrium with water containing ozone. Due to the local high gas concentration generated there, bubbles are generated on the anode side 124. The bubbles coalesce in the flow to form a headspace 136, and usually in a well-mixed system, the headspace 136 will be roughly in equilibrium with the water. It is important to control the volume of the headspace 136 and the entrained gas in any outlet. Conventional ozonation systems use a venturi to dissolve ozone gas into water flowing through the pipe, but this method cannot prevent undissolved gas from flowing to the dental handpiece, and does not support systems using low flow rates below 40 ml / min, and typically less than 20 ml / min, because these flows lack the energy (fluid velocity and volume) to produce sufficient ozone concentration by pulling the gas into the flow path.

[0092] As part of the optimized flow system, the bubble-free portion of the flow is directed to the output of the flow system into the ultrasonic handpiece 108 in response to user demand. It can also provide some buffering or averaging of ozone concentration and system pressure fluctuations. In addition, the pump operates most efficiently without bubbles. When the ozone generating unit is operating, bubbles are present in the flow system, so bubbles are continuously separated from the flow to produce bubble-free ultrasonic dental cleaning irrigate, thereby preventing gas escaping from the irrigate from entering the patient's mouth. At a minimum, the gas separator also provides a buffer reservoir for ozonated water, a gas head space 136 buffer volume, an area for water level sensing, and connection points for multiple gas and water connections. In the illustrative embodiment, the following functions are combined in a single aqueous ozone ultrasonic scaler system 100, including: (i) employing multiple recirculation loops 132 and corresponding gas separators, such as two recirculation loops 132, each with a gas separator that separates the water volume, so that the system polarity can be alternated to provide rapid production of aqueous ozone water and extend the shelf life of the electrolytic ozone cell 106 (while the gas separator 116a at the anode side 124 of the electrolytic ozone cell 106 can be in use, the other gas separator 116b at the cathode side 126 can be out of use, and the switching of polarity can ensure that the gas separator 116b at the cathode side 126 is now on the anode side 124 and is therefore ready to operate). For example, the polarity switching can occur daily and will keep the cell healthy and thus maintain good performance, i.e., it is able to reach the target concentration in a short time (e.g., within 30 seconds) and maintain that concentration during the cleaning period. During the cleaning period, the water in the system is continuously diluted because the aqueous ozone flows out of the handpiece and fresh water is pumped into the system. To maintain the level in the separator, the ozone concentration is diluted, requiring the EO cell to be on and maintain the concentration. Another important reason for the polarity switch is to eliminate the need for daily system flushing, which takes time and wastes water. If (for example) the catholyte water is not flushed daily, it will not be emptied or replaced. The polarity switch there ensures that the catholyte side is switched to the anolyte side, which is then ozonated and replaced during dental cleaning, (ii) removes entrained gas from the output of the gas separator to provide a bubble-free ultrasonic dental cleaning irrigation and prevents gas from escaping from the irrigate into the patient's mouth, and (iii) provides a clear water sample to the UV sensor 110 (bubbles reflect and diffract UV light to produce erroneous signal measurements.(iv) provide pressure smoothing in the circuit, (v) reduce concentration fluctuations at the output end by controlling the electrolytic ozone cell 106, (vi) extend the time scale of the control circuit (reduce bandwidth), (vii) make the cell flow parameters of the electrolytic ozone cell 106 independent of the output flow of ozonated water into the ultrasonic handpiece 108 by using the controlled output of the gas separator, (viii) provide a head space 136 for separating and collecting excess gas from the system, (ix) smooth system pressure fluctuations, and (x) isolate the water reservoir from the head space connection, for example to the ozone destructor 114.

[0093] The system topology combines throughflow with an internal recirculation loop 132 to coordinate the different flow conditions required for optimal electrolytic ozone cell 106 and ozonated water delivery. Due to heat and bubble transport reasons, the cell operates best in a near steady state with high water velocity on the electrode plates. The output flow must be responsive to user control and can be highly intermittent.

[0094] Bubbles have a natural rise rate in water, and in order for flotation to efficiently remove bubbles from the flow, a portion of the flow must have a free surface where the residence time is greater than the maximum rise time of the bubble to the surface. The maximum rise time is a function of the bubble size and the height that the bubble must rise to reach the surface. In an illustrative embodiment, a design feature of the separator may be that the inlet flow is directed to the free surface of the reservoir, but from below so that it does not cause turbulent bubble entrainment of additional gas from the headspace into the liquid. The system manages the fluid level by using a water level sensor such as sensor 102 to maintain a non-entrainment condition during normal operation.

[0095] In another illustrative embodiment, the flow path from the electrolytic ozone cell 106 to the separator maximizes bubble coalescence and minimizes bubble breakage to ensure that the average bubble size is as large as possible. Larger bubbles rise faster, so better separator performance or a smaller separator working volume can be used.

[0096] In another illustrative embodiment, the incoming flow of water into the separator is obstructed and conditioned by baffles to minimize jetting and reduce the cleaning of turbulent eddies in the incoming flow region, as described below.

[0097] In another illustrative embodiment, the liquid volume of the separator is provided with spaced baffles to inhibit the bulk overturning flow in the chamber, thereby reducing the likelihood of bubbles being carried downward toward the outlet port by relatively low energy circulating flow. The inlet and baffles are designed to produce a uniform slow moving downward flow as much as possible over the entire chamber area. The eddies in the flow must be smaller than the spacing of the baffles, and the spacing can be adapted to suit the chamber shape and the placement of the inlet and outlet ports.

[0098] The separator chamber is characterized by a cross-sectional area that satisfies the following relationships: (i) bubble rise time < water residence time in the reservoir; (ii) bubble rise velocity (for target diameter cutoff) > average flow velocity downward in the chamber; (iii) bubble behavior and flow conditions in the separator are determined by several interacting design parameters; (iv) bubbles penetrate as little as possible into the water in the chamber (there is a balance between bubble removal and mixing of fresh ozonated water with the separator volume diluted by fresh input water. If bubbles exiting the recirculation loop input are allowed to penetrate the entire liquid volume in the separator, they are likely to be pulled into the recirculation loop outlet port or fluid discharge port. Therefore, bubbles are directed to the gas-liquid interface so that they can be released to the gas side without entering the discharge pipeline or re-entering the recirculation loop). The incoming flow is directed toward the free surface, and overturning cycles that carry bubbles into the water are suppressed; (v) the diameter of the vortex flow in the chamber is set by the lateral dimension of the flow volume. The subdivision of the volume is such that the vortex size is limited, thereby limiting the penetration depth of the bubbles; (vi) the average flow velocity in the chamber is less than the rise velocity of the smallest bubble that needs to be removed; (vii) the velocity variation across the chamber is as low as possible, i.e. it approximates a laminar plug flow profile; (viii) the exit point of the chamber, particularly the exit point of the delivery flow path, is placed where the likelihood of excessive downward flow velocity is minimized. This minimizes the chance of any bubble reaching the exit point; (ix) the exit flow port is obstructed by a baffle so that it draws flow relatively uniformly from the entire chamber area.

[0099] The cross section of the chamber that meets the above-mentioned conceptual design rules can be cylindrical or rectangular. Its aspect ratio (height / width) can be>1, preferably>2. The subdivision of the chamber can be in different forms, such as square or circular or hexagonal, without affecting the function, and the separation element can span from the base of the chamber to the free surface or slightly away from these surfaces, but there is no limit. The height of the gas head space 136 above the free water surface is determined by other factors and can be widely varied without affecting the bubble separation function of the water volume. For use with ozonated solutions, preferably, the wet surface is entirely composed of ozone inert materials, such as fluoropolymers, or substrates coated with a protective layer that does not react significantly with ozone. Associated with the chamber can be a level sensing means, such as sensor 102. The structure of the chamber can be adapted to allow level sensing by, for example, a capacitive sensor or by other depth sensors integrated into the chamber without affecting the function.

[0100] The combination of the compressible gas volume in the fluid connection and the reservoir volume 138 results in smoothing of pressure pulses in the circuit connected to the volume. In this system, this smoothing effect applies to the incoming flow from the air pump 118a (or air pump 118b), to the recirculating flow through the reservoir volume 138, and to the outflow to the outlet 140. If there are applicable standards that allow pressure pulses in any of these flows, and the source of the pressure pulses is known (e.g., a pump or valve), then the volumes of fluid and gas in the adaptation chamber can be adjusted to provide the necessary filtering of pressure changes and time. The specific volume values ​​required also depend on the inertia of the associated pipeline flow and the elasticity of the pipeline. In the illustrative embodiment, the elasticity of the pipeline is negligible, and the pressure smoothing optimization is derived by calculating the flow inertia and the chamber volume.

[0101] The gas separator provides a reservoir volume 138 of aqueous ozone to be drawn from during the dental cleaning procedure, rather than drawing the flow directly from the electrolytic ozone tank 106. The system can use a control setpoint for the ozone level in the chamber, which is efficiently circulated and mixed through the tank by recirculation independent of the output flow. Therefore, the ozone sensor control loop can be implemented without the risk of error due to uneven flow patterns through the sensing element or variable ozone decomposition during low flow or no flow periods through the sensor. The reservoir with aqueous ozone minimizes the variation of the ozone level flowing out to the ultrasonic handpiece and decouples the output flow rate from the transient electrolytic ozone tank 106 operating parameters or the transient operation of the drive pump. When the fluid distributed as aqueous-ozone-ultrasound-irrigation fluid leaves the system via the ultrasonic handpiece 108, it must be replenished. Fresh water enters the system to make up for the output flow to maintain the water level in the separator. The fresh water mixes with the fluid in the separator and the recirculation loop, resulting in some dilution, which is restored by the electrolytic cell under the control of the ozone sensor. Preferably the time constant of the control loop is short compared to the usage timing of the system, but there is no need to compensate for every momentary fluctuation in operating conditions as these are naturally smoothed out by mixing processes in the chamber and flow circuit.

[0102] Because of the separator volume, the system will need to be charged with that volume of water at start-up before the desired ozone concentration can be achieved. The target concentration level can be achieved by driving a specific current for a period of time, such as 500ma for 2 minutes, or using a closed loop controller monitoring a UV sensor to determine the level of dissolved ozone in the separator and recirculation path.

[0103] In order to improve the efficiency of the electrolytic ozone cell 106, the bubbles formed at the three-phase boundary of the electrolytic cell are separated from the electrode surface to prevent them from reducing the effective working area. To achieve this, the recirculating flow and the electrolytic cell flow channel are adjusted to be a high flow velocity at the surface. If the output flow directly reaches the output end through the cell, then even if there is a buffer volume in the middle, the cell speed will also depend on the output flow demand and change, so that the instantaneous operating conditions in the cell cannot be fully determined, and the flow rate modulation of the cathode side flow rate also needs to be matched to maintain the desired pressure balance on the electrode and the membrane assembly. Dynamically modulating two flow paths in this way will bring serious control burdens to the entire system. In addition, below the threshold flow rate, the failure of cell heating or bubble removal will become a risk, and it is further necessary to modulate the cell current to respond to the instantaneous output ozone level, and respond to the thermal limitations of the electrode assembly under low flow. The system includes a cross flow path that solves many of these problems at the same time, using a gas separator component as an element that allows the combination of flow paths to be realized and meets all system requirements. The recirculation flow rates between the reservoir volume 138 and the electrolytic ozone cell 106 can be independently set to provide optimized cell operating conditions and stable conditions at high flow rates while also allowing the electrolytic cell flow channels to provide refill and output flows at appropriate rate and pressure characteristics.

[0104] When operating at high flow rates and narrow flow paths, there is a significant pressure drop in the electrolytic ozone cell 106. The system design allows this pressure drop to be located inside the recirculation loop while not affecting the significant pressure drop in the throughflow path. Therefore, the system can be further optimized compared to individual pressure requirements that are applied to a common flow path. In an illustrative embodiment, the average operating pressure of the system represented by the gas separator is set to the operating pressure of an attached instrument such as an ultrasonic handpiece 108. The additional pressure required to drive the flow through the electrolytic ozone cell 106 is not in series with this pressure, but only appears at the connection between the recirculation pump and the electrolytic ozone cell 106.

[0105] The inlet 142 of the gas separator(s) greatly reduces jet turbulence and allows the main volume of the gas separator to operate in a calm flow mode due to the use of an inlet baffle 1304, such as Fig.13A The immediately diverging flow is shown in . The combination of inlet baffle 1304 and tube array 1314 slows down and controls the flow into the separator. The challenge is to reduce the jet velocity from the inlet tube in a short distance. Simply increasing the diameter does not work due to flow separation and uneven velocity distribution. Even a slowly tapering expansion cannot prevent this mixing. The basic concept combines obstacles to divert the jet into radial flow, thereby preventing separation, and then a "stratified" section filled with narrow tubes to force piston flow at a low average velocity. Testing has shown that 1000ml / min is easily achieved with a 1cm diameter. As shown in Fig. 13BAs seen in FIG. 1 , most of the bubbles escape at surface 1302 and the chamber baffle 1308 inhibits the overall overturning cycle where the bubbles rise faster than the water flows down 1306. Fig. 13C As shown in FIG, a solid middle portion 1312 of the manifold 1310 prevents surface disturbances from affecting the sensor 102. The manifold 1310 has openings around the top and bottom for equilibrating the water and gas levels in the center region.

[0106] For all bubbles of interest, the average downward water velocity is less than the upward bubble velocity, allowing them to escape into the headspace. Small bubbles rise much more slowly than large bubbles, so the critical diameter can be found by equating the water velocity and the rising velocity using an established relationship.

[0107] In a non-limiting embodiment, for very small bubbles, the velocity of the bubble can be expressed by the Hadamard / Rybcynski relationship as velocity V = ρ.gd^2 / 12.μ, for 0.2 to 2 mm bubbles, an alternative is V(m / sec) = 120*d(m), where ρ is the density of the fluid, g is the acceleration due to gravity, d is the diameter of the bubble, and μ is the dynamic viscosity of the liquid.

[0108] In addition, for very small bubbles, there is a regular relationship between size and velocity, as well as the effects of temperature and ionic strength on velocity. However, the effects of temperature and ionic strength are likely to be small.

[0109] The analysis gives an example value for the area equivalent to a 3 cm diameter separator (the actual internal diameter is 3.3 cm, minus the inlet pipe area to give this clear flow area).

[0110] Flow = 500 ml / min = 8.33 ml / sec. Area = 7.1 cm2 Downstream velocity ~1.2 cm / sec. Bubble size at Vrise = 1.2 cm / sec is about 100-140 um. With uniform flow in the separator, all bubbles larger than ~100 um will escape. The fast jet inlet flow drives the circulating vortices much faster than the average flow, so this affects the separation performance. The turbulence does not have enough volume to dissipate the energy. Using a calm inlet, and some further plug flow forcing baffles in the main chamber, one can strive for close to theoretical separation performance in the same chamber volume.

[0111] Other illustrative embodiments to improve performance include a larger diameter flow diffuser on the inlet, e.g., about 15 mm, and the addition of a "jet baffle" at the inlet. Additionally, a larger laminar flow tube in the inlet is used to reduce bubble breakup, and a smaller diameter (e.g., about 5 mm) tube fill in the main chamber volume is used to further suppress vortices. It is contemplated to prevent the inlet flow from "short-circuiting" the recirculation fill and reaching the recirculation outlet.

[0112] In order to deliver aqueous ozone to the ultrasonic handpiece 108, the system pressure (which can range from 15 to 40 psi, but more typically 22 psi) is required to be determined by the pressure required to produce an output flow rate of up to about 65 ml / min or less, but more typically 25 ml / min. Some ultrasonic plug-ins are designed with small fluid paths through the tip of the plug-in. These fluid paths can be less than 0.020 inches, and are typically less than 0.015 inches. The system pressure also affects the gas dissolution rate of ozone, which is an important factor to consider when quickly charging the system to the desired concentration at startup. The pressure in the system is generated by the gas produced by the pump (air pump, main water pump) and the electrolytic ozone tank 106. The air pump is mainly used at startup for high flow output periods where additional input may be required to maintain system pressure to deliver continuous flow, and can also be used to purify the aqueous ozone ultrasonic scaler system 100 for long-term storage and shipping without storing water in the gas separator. The main water pump 118c fills the system and the gas separator, and it also adds fluid to the system when the system operates at a system pressure of about 22psi, but can be operated in a range of, for example, 15 to 40psi, or even below 15psi and over 40psi. As the electrolytic ozone cell 106 adds gas to the system, the system pressure will continue to increase, and the system pressure can be controlled by pressure regulation. Electronic control is performed by the valve 120 that is opened and closed by the software based on the input from the pressure transducer. In the illustrative embodiment, the gas in the buffer volume 134 can be released by two valves 120 in series, the first will open and discharge a small volume, and then close and the second valve 120 will open to discharge a small volume through the ozone destroyer 114 that converts ozone gas into oxygen. This valve switching prevents the system pressure from dropping rapidly. A mechanical method of limiting and controlling system pressure is to release the gas in the separator head space via a pressure relief valve. The pressure relief valve uses seal and spring pressure to open and exhaust only when the system pressure exceeds the seal pressure generated by the spring force. A pressure relief valve with fast action and very low mechanical hysteresis will provide a stable upper system pressure. A pressure transducer can be used with the system pump to increase the system pressure to support the desired output flow and gas solubility. In addition to these pressure control means, there is a level sensor 102 that maintains the fluid level in the separator. Maintaining the proper fluid level controls the volume of the gas head space and prevents rapid changes in the head space volume that would affect the system pressure. An important advantage of the aqueous ozone ultrasonic dental scaler system 100 architecture over conventional water ozonation systems is that it is able to go from no dissolved ozone to full fill in, for example, less than 3 minutes, and potentially achieve full fill in 30 seconds.

[0113] When using the aqueous ozone ultrasonic dental scaler system 100, the following steps can be performed. The air pump 118a on the gas side is turned on to fill the system pressure. Water from the closed system container is pumped into the system until the level sensor 102 reaches their preset volume. In the illustrative embodiment, these steps occur in less than 10 seconds and are likely to reach the preset value in less than 2 seconds, so that the system fluid and operating pressure reach their desired levels. (The fluid level in the system will need to fill the fluid path and add enough volume to the gas separator to create a water reservoir and gas head space. In the illustrative embodiment, the gas separator can be filled with, for example, 20-80% of water, or even 40-60% typically, or just above the baffle in the gas separator. The pressure in the system increases from near zero psi. By pumping in water to reduce the gas volume, some pressure is added to the system, but the exhaust solenoid valve usually helps to open more quickly to fill the system with water. Once the desired water level is reached, the air pump is activated to quickly fill the system pressure to 15 to 40 psi, typically 22 psi). At this time, the system recirculation pump is turned on and the driving current is delivered to the electrolytic ozone cell 106. In an illustrative embodiment, the electrolytic ozone cell 106 can be powered by 1.1 to 7 times of its normal operating current during the initial charging of the aqueous ozone ultrasonic scaler system 100 to achieve fast system charging. The recirculation pump can also be operated at a higher duty cycle or voltage to increase the recirculation rate to help quickly extract the gas from the electrolytic cell, so that small bubbles are quickly swept away from the three-phase boundary of the cell membrane electrode interface. Compared with larger bubbles formed by the combination of smaller bubbles or by the delayed release of the surface of the cell three-phase boundary, these small bubbles provide a larger surface area. Due to the higher system operating pressure, the gas from the electrolytic ozone cell 106 is dissolved more quickly into the recirculating water. The solubility of ozone in water depends on the temperature of the water, the concentration of the dissolved ozone gas, and the pressure in the system containing the recirculating water and the ozone gas. Higher pressure is equivalent to higher dissolved ozone levels. In the illustrative embodiment, by operating at a pressure of 20 to 24 psi above one atmosphere, more than twice the amount of ozone can be dissolved into the system water. Entrained gases are separated from the recirculation loop and then sent through the UV sensor 110. The UV sensor 110 monitors the startup routine and enables the closed-loop controller to achieve a steady-state condition that returns both the electrolytic ozone cell 106 and the recirculation pump to normal power levels. Limiting the higher current flowing to the cell and motor to only the startup sequence improves reliability and cell membrane life. During startup, the dental clinician can immediately begin filling the ultrasonic handpiece 108 with water to prepare the system, and they can also begin using the ultrasonic plug-in for cleaning or rinsing. However, this may slow down the total charging time or require more power to the cell to achieve a quick charge due to the additional dilution of fresh water entering the system.

[0114] In another illustrative embodiment, the aqueous ozone ultrasonic dental scaler system 100 is designed so that both the cathode side 126 and the anode side 124 are symmetrical or substantially symmetrical. In doing so, the gas separators for the cathode and anode are the same or substantially the same in size, construction, volume, and their ability to separate bubbles from the fluid. In the illustrative embodiment, both sides have dissolved ozone sensors, for example, each side has a UV sensor 110 ( Fig.14 ), a UV sensor 110 can measure two separate fluid paths, each belonging to one side, or a single UV sensor 110 has a series of isolation valves that can redirect any fluid path of the system through the sensor to enable the system to monitor ozone gas in any recirculation loop 132. The ability to measure ozone gas in two recirculation loops 132 simultaneously or in an alternating manner can provide additional self-diagnosis. By monitoring both sides, it can be decided to maintain the anode as an anode, or if the ozone level is acceptably low (e.g., less than about 0.2ppm or undetectable), the system can reverse the polarity. The software of the aqueous ozone ultrasonic scaler system 100 changes the polarity of the electrolytic ozone cell 106 through, for example, an H bridge, and provides an output stream from the outlet 140 that generates ozone on either side of the system. Another benefit of monitoring the ozone level in the anode and cathode is to monitor gas crossover. Ozone in the cathode recirculation loop may indicate early signs of cell membrane perforation or loss of fluid and / or gas seals. This type of self-diagnosis can help alleviate safety issues and alert end users before loss of function or performance.

[0115] The need to switch the system polarity comes from the need to maintain the fluid level in the cathode liquid and important system characteristics related to reliability. During operation, water molecules are pulled through the membrane 202 via electroosmosis. Over time, the gas separator 116b will increase its fluid level (as water migrates from the anode to the cathode via electroosmosis or leaks from the fluid inside the EO cell, the cathode electrolyte volume increases). Without a reason to discharge or discharge from the cathode side of the system, the gas separator 116b will be filled and eventually need to be discharged. For example, by switching the entire system polarity every day, a small increase in fluid level after a day of use can be easily managed. The reliability requirements associated with polarity switching stem from the long-term performance goals of the electrolytic cell and the need to maintain the cleanliness of the water in the cathode electrolyte without the need for special startup or shutdown process steps. Additional maintenance steps would be undesirable because of the extra time involved or the need to install or conveniently locate the drain. Ultrasonic dental scalers are typically located on countertops, cabinets, or in special drawers designed for operating equipment. However, these locations do not provide access to the drain, so the system requires a trash can to collect the cathode electrolyte water at the end of the day. Or the clinician must purge any fluid from the system into an operating tank by running a special purge cycle. The purge cycle will run the maintenance pump, a small diaphragm air pump, which will push water out of the system through an open water solenoid and into the handpiece. During this purge cycle, the water will be dispensed into a nearby tank or small reservoir. During this purge, there is a risk that ozone gas stored in the headspace will also be exhausted from the handpiece. This would be an undesirable exposure to ozone gas. To avoid this exposure and the need to run a special purge cycle that is inconvenient and requires additional setup time, a system that is capable of changing polarity daily automatically refreshes and ozonates the catholyte side of the system from the previous day.

[0116] Since the water on the cathode side of the system is not used during cleaning, it needs to be regularly replaced via additional settings or shutdown steps. This water can be replaced via a cleaning process that requires a small air pump, which can transfer water from the cathode side of the system to a waste container, a drain pipe, or through a valve connected to an ultrasonic handpiece 108. These options may require special cathode cleaning steps during the startup or shutdown of the ultrasonic scaler. During the cleaning procedure, water will be transferred by a pump from a pure water source that is both tamper-proof and designed with custom accessories (such as from a customized closed water packaging system (e.g., a nozzle bag 704)). Water flows through the anode side 124 of the system, where ozone is dissolved, and then it is delivered to the ultrasonic handpiece 108 as a cooling irrigant for the transducer and the ultrasonic scaler tip. During startup, the cathode separator (gas separator 116b) is filled with an appropriate volume of water to recirculate through the cathode side of the electrolytic ozone cell 106 to perform a reduction reaction.

[0117] Alternatively, the cathode and anode can be switched, for example, every day. During non-working periods, such as 12 to 16 hours when the system is not used, ozone will decay naturally, and the half-life of aqueous ozone is generally about 20 minutes, thereby avoiding any concerns about cross-gas effects. Once ozone decays to less than about 0.5ppm or less, the risk of reverse chemical reactions at the three-phase boundary of the electrolytic ozone cell 106 will be minimized. The system can safely change the polarity of the cell by switching the electrical polarity of the cell. The software drives this change in polarity so that aqueous ozone is delivered by opening the appropriate solenoid valve. By changing the polarity, the remaining cathode water from the previous day will be recycled through the electrolytic ozone cell 106 on its positive or oxidizing anode side 124. The remaining anode water from the previous day will decay naturally, so the ozone in the corresponding separator will return to oxygen, and these waters will be recycled through the reduction side of the cell-cathode. Both separators require fluid lines and solenoid valves that deliver water to the ultrasonic handpiece 108. By switching polarity every day and only after verifying that the ozone level has decayed, the cell can alternate its anode and cathode, thereby helping to limit any fouling caused by deposits that are usually deposited on the cathode electrode. The membrane degradation caused by the interaction of ozone and other oxidizing substances (HO, H2O2, H3O...) can be distributed on both sides of the cell, thereby extending the life of each membrane. In addition, the cathode electrolyte will be replaced every day, and each side of the system will be ozonated, thereby preventing stagnant water and eliminating or substantially eliminating the possibility of microbial contamination. Of course, other arrangements that prevent stagnant water, reduce ozone exposure and increase the life of membrane 202 can be obtained according to this specification. The examples in this disclosure are only for clarity of description and do not limit the illustrative embodiments. Additional operations, actions, tasks, activities and manipulations will be conceivable from this disclosure, and they are contemplated within the scope of the illustrative embodiments.

[0118] Additionally, optical methods that utilize ozone’s UV absorption to detect dissolved ozone levels in water may require offset correction to account for changes in mechanics and optical paths (i.e., debris, aging of the UV source). By implementing a daily polarity change to the system, the catholyte water from the previous few days, i.e., the water with dissolved hydrogen, can be used to zero any sensor offset, thereby making the correction, without changing the concentration of the absorbing component in the water.

[0119] Ozone gas is known to cause respiratory irritation, therefore, to prevent patients from inhaling ozone gas, the illustrative embodiment has established controls on ozone concentration and limits on ozone generation. Ozone released by the system comes entirely from the delivered water stream. All gaseous headspace ozone from the gas separator is catalytically destroyed before being discharged into the local environment.

[0120] One issue with using ozonated irrigants for dental cleaning is that oral air must be maintained within the oral cavity (the local environment created by the natural diffusion of dissolved ozone from the irrigant). If the ozonated water delivered to the patient's mouth accumulates and off-gasses before being drained from the mouth by the clinician, exposure risk may occur during the dental cleaning procedure.

[0121] By fully integrating ozone generation and control into the ultrasonic scaler electronics, exposure to ozone gas can be mitigated by monitoring the use of the system during a single procedure, thereby providing the ozone control system with a specific mechanism to limit exposure to ozone gas. Ultrasonic scaler parameters that may affect the amount of ozone gas released into the oral cavity include, but are not limited to, the flow rate of the irrigating fluid, the ultrasonic power level, the duty cycle of the scaler protocol, and the type of suction used, i.e., high volume evacuation and / or saliva ejector.

[0122] The ozone concentration directly determines the amount of ozone available in the irrigating fluid. For patients with healthy gums, clinicians can choose to use a lower concentration of ozone, a level that is only necessary to inhibit biofilm growth in the system water lines, such as 0.020ppm to 1.0ppm, with 0.5ppm being more typical. For patients with gingivitis or periodontal disease, users can select higher concentrations, 1.2 to 3.0ppm and 3.0-6.0ppm, respectively.

[0123] The control system can operate with a real-time clock, allowing the scaler to track usage. The total cleaning time for each patient can be displayed and automatically reset after a period of inactivity, typically 30 minutes to an hour. This usage data can also be used to monitor the total amount of ozone generated and dispensed over time. If a long cleaning session at a high concentration has been reached, the system can automatically reduce the ozone concentration. For example, it may be found that a cleaning session of more than 45 minutes at 3.0 to 6.0 ppm reaches the patient's safe exposure limit.

[0124] To ensure suction is being used, the system can be equipped with an ultrasonic microphone. The ultrasonic microphone is capable of detecting acoustic emissions resulting from the use of suction. If the system is unable to detect the use of suction, then the clinician may be prevented from delivering higher concentrations of ozone. By positioning the ultrasonic microphone in the handpiece cable, it can be placed close to the handpiece. The system housing can be equipped with several ultrasonic microphones to provide a full range of detection capabilities. The ultrasonic microphone can be trained to the sounds of specific operating saliva jet suction and high volume emptying. Or the system can be preprogrammed to recognize low suction and sufficient suction to achieve higher concentrations when the clinician chooses. High volume emptying can remove liquid and gas at a typical rate of 200 to 250 LPM (liters per minute). This level of suction eliminates the risk of any ozone escaping from the ultrasonic lavage being inhaled by the patient before being aspirated from the mouth.

[0125] The complete integration of the ultrasonic scaler electronics and the ozone control circuit system enables the creation of a control loop that takes into account both rectified diffusion and rapid decomposition. Rectified diffusion is the result of acoustic energy shearing dissolved gases out of solution because oscillating sound waves cause bubbles to form. These bubbles expand and compress as the sound waves pass through the solution, and the gas can diffuse into these bubbles and prevent them from bursting, thereby essentially releasing the dissolved gas. These small bubbles may flow through the handpiece and exit at the tip of the ultrasonic handpiece 108. Since rectified diffusion can increase the release of ozone gas in the oral cavity, the ozone concentration for various levels of ultrasonic excitation can be directly controlled by the integration of the two electronic control circuits. Rapid decomposition is the accelerated decay of ozone into oxygen by mechanical excitation, in which case the system can increase the ozone concentration to help maintain sufficient ozone levels in the irrigation fluid to reach the periodontal pocket.

[0126] Ultrasonic scalers use irrigating fluid to cool the transducer and ultrasonic scaler tip. The clinician can adjust the flow rate of the ultrasonic scaler, and while typical flow rates are between 15 and 25 ml / min, the system can be operated at as low as, for example, 2-5 ml / min at the low end of the flow and as high as, for example, 30-45 ml / min at the high end of the flow.

[0127] In an exemplary embodiment, the gas separator 116a or the gas separator 116b provides a fluid level that can be monitored using non-contact fluid level sensing (e.g., capacitance or optical methods). By monitoring the fluid level in the anode separator, the fluid flow rate out of the system can be calculated. The system operates at a pressure of typically 22psi. When the output solenoid is turned on, the pressure stored in the system forces water to pass through the open output solenoid and enter the cable of the ultrasonic handpiece 108 through the flow control unit and enter the handpiece, and finally flow out of the irrigation port on the plug-in of the ultrasonic handpiece 108. The flow control unit is a mechanical device that may not be able to communicate directly with the system electronics. Alternative flow controls can be handled via proportional valves, servo-controlled valves, servo-controlled mechanical regulators, or simply adjusting the system's internal operating pressure. When the clinician adjusts the mechanical flow control unit located at the handpiece and the handpiece cable interface, the rate at which the anode separator volume decreases can be detected. During the period when the main pump fills the anode separator, the system software can know not to calculate the water use rate. During the filling time, the level sensor can also be used to determine whether the main pump is operating normally and whether the water container has been emptied. If the water container is empty, then the main pump will not be able to fill the anode separator. A timer will be set to provide sufficient time, such as 50 milliseconds to 10 seconds, for the pump to increase the level in the anode separator. If a leak occurs due to a failure on the gas or fluid side of the system, ozone gas may be released into the operating chamber. The system is able to identify a rapid drop in system pressure, resulting in the generation of ozone and the delivery of ultrasonic cleaning power being disabled. In addition, the aqueous ozone ultrasonic scaler system 100 can have an internal gaseous ozone gas monitor 112 that automatically stops the generation of aqueous ozone if the internal (inside the system housing) gaseous ozone level exceeds 100 ppb. In addition, in the illustrative embodiment, the fluid pathways of the device are all closed except for the location where the ozonated water leaves the tip of the plug for delivery to the patient's mouth.

[0128] In yet another alternative embodiment, two water bags / sources 104 (e.g., spray bags 704) provide the added convenience that if one bag is empty, the dental procedure is not interrupted, such as Fig.15 The system will be able to sense when the bag is empty and automatically switch by using the ozone system main control board 406, for example, the sensor may be lack of fluid flow, failure to increase the level in the separator, or simply loss of liquid. The motor current can also be monitored to identify whether there is fluid in the pump. Use Fig.16 The two pressure relief valves (Pressure Relief Valve B 1602 and Pressure Relief Valve A 1604) ensure that hydrogen and oxygen do not mix on the gas side, thereby protecting the membrane from cross-gas reactions that could limit its service life.

[0129] Figure 7A schematic diagram of a connection assembly 702 according to one embodiment is depicted. The connection assembly 702 is integrated into the water source 104, such as a nozzle bag 704 (also shown in FIG. 1 ) for connecting to an aqueous ozone ultrasonic dental scaler 706. Figure 8 ).

[0130] Fig. 9 An interaction according to one embodiment is depicted. The interaction includes: stage 902, wherein the outer cover is removed from the aqueous ozone ultrasonic dental scaler 706; stage 904, wherein the nozzle bag 704 is inserted into the outer cover; and stage 906, wherein the outer cover is reinserted into the aqueous ozone ultrasonic dental scaler 706.

[0131] Fig.10 A schematic diagram of a connection assembly 702 timeline according to one embodiment is depicted with a front connection 1002 and a rear connection 1004. In the illustrative embodiment, the connection assembly 702 includes: a duckbill 1006 providing a non-refillable port, a dental instrument connector 1008 for connecting to an aqueous ozone ultrasonic scaler 706, an o-ring 1010 providing a seal to prevent spillage, and a foil seal 1012 that is pierced during insertion, as shown in the rear connection 1004.

[0132] Fig.11 Another view of a connection assembly 702 is depicted according to one embodiment, which also includes a duckbill valve 1102 including a duckbill 1006. The assembly is connected by ultrasonic welding / snaps / adhesive 1104.

[0133] Fig.12 An exploded view of the connection assembly 702 is depicted in greater detail. The connection assembly 702 includes a dental instrument connector 1008, a foil seal 1012, a duckbill valve 1102, a spout body 1202, and a spout cover 1204.

[0134] Fig.17A An alternative configuration of an aqueous ozone ultrasonic dental scaler 706 (aqueous ozone ultrasonic dental scaler configuration A 1702) according to one embodiment is depicted. The aqueous ozone ultrasonic dental scaler configuration A 1702 includes two water sources 104 configured in series, which allows the aqueous ozone ultrasonic dental scaler 706 to have a narrow profile. It also includes a level 1708 indicating the level of fluid water in the water source 104.

[0135] Fig. 17B An alternative configuration of the aqueous ozone ultrasonic scaler 706 (aqueous ozone ultrasonic scaler configuration B 1704) is depicted according to one embodiment having two water sources 104 configured in parallel which allows the aqueous ozone ultrasonic scaler 706 to have a wide profile.

[0136] Fig. 17CAn alternative configuration of the aqueous ozone ultrasonic scaler 706 (aqueous ozone ultrasonic scaler configuration C 1706 ) is depicted according to one embodiment. In this embodiment, the spray bag 704 is stored in a compartment 1712 below the user interface 1710 .

[0137] Fig.17D Other illustrative shapes for water source 104 are depicted including plastic spout bag 1714, carton 1716, and bottle 1718.

[0138] Fig.18A (Ozone water ultrasonic scaler configuration D 1802) and Fig.18B (Ozone Water Ultrasonic Scaler Configuration E1804) depicts another alternative configuration of the system, where the plastic spray bag 1714 and the carton are used in a parallel configuration to produce a scaler with a wide profile, rather than Fig. 18C Narrow profile scaler (Ozone Water Ultrasonic Scaler Configuration F 1806). In any of the configurations discussed herein, the ultrasonic handpiece 108 can be a magnetically coupled handpiece (double sided) 1808 that attaches to the base of the scaler by magnetic means.

[0139] Figure 19A-19B Also depicted is an alternative configuration of an aqueous ozone ultrasonic scaler configuration C 1706 having a compartment 1712 that receives a source of water as a carton 1716 or bottle 1718 .

[0140] In yet another illustrative embodiment, Fig. 20A A configuration having a base 2002 and a removable interface 2004 is depicted, and Fig. 20B A hand piece holding port 2006 and a loading tray with lighting 2008 in the bay 1712 area are depicted.

[0141] method

[0142] Now go to Fig.21, the process 2100 2100 according to an illustrative embodiment will now be described. The process 2100 is by delivering deionized water from a water source 104, as shown in step 2102. In step 2104, water is pumped via a pump such as the main water pump 118c to maintain fluid levels and obtain sufficient pressure to increase gas solubility and ultimately drive the water to the handpiece. In step 2106, the water is moved through an electrolytic cell (such as the electrolytic ozone cell 106) in the recirculation loop using a corresponding pump (such as, air pump 118a and air pump 118b) of the recirculation loop. Oxygen and ozone gas are generated on the anode side by electrolysis in step 2108, and hydrogen is generated on the cathode side. In the next step, step 2110, the entrained gas is dissolved in the water and excess gas is separated from the recirculated water. Excess gas is discharged through the ozone destroyer 114 using a valve 120, such as a pressure release valve. In step 2112, a defined ozone level is maintained by controlling the amount of current supplied to the electrolytic ozone cell 106, such as (~0.5ppm) to maintain the waterline or (4-6ppm) to deliver clinical efficacy. Step 2114 includes using a uv sensor 110 to monitor the ozone concentration in the fluid passage 144 and controlling the generation of ozone by modulating electrolysis generation. Multiple uv sensors 110 can be used, for example, one for each polarity configuration (polarity switch). In step 2116, when (one or more) pumps maintain a defined fluid level and system pressure, a water solenoid valve is used to control the flow of aqueous ozone from the pressurized system to the ultrasonic handpiece 108. In addition, the aqueous ozone ultrasonic scaler system 100 is configured to report, for example, the status of the water level, or respond to a user's request for aqueous ozone, and control the safety and efficacy of the system in step 2118. Process 2100 ends thereafter (step 2120).

[0143] Computer Systems

[0144] Having described the apparatus, reference will now be made to Fig. 22 , which shows a block diagram of a computer system 2200 that can be used according to at least some illustrative embodiments herein. Although various embodiments may be described herein in terms of this exemplary computer system 2200, after reading this description, it may become apparent to one skilled in the relevant art(s) how to implement the present disclosure using other computer systems and / or architectures.

[0145] In an exemplary embodiment herein, at least some components of the aqueous ozone ultrasonic dental scaler system 100, such as the ultrasonic control board 404 and the ozone system main control board 406, may be formed or included in Fig. 22The computer system 2200 includes at least one computer processor 2206. The computer processor 2206 may include, for example, a central processing unit (CPU), a multi-processing unit, an application specific integrated circuit ("ASIC"), a field programmable gate array ("FPGA"), etc. The computer processor 2206 may be connected to the communication infrastructure 2202 (e.g., a communication bus, a cross bus device, a network). In the illustrative embodiment of this document, the computer processor 2206 includes a CPU that controls the timing of the electrolytic ozone cell 106 and the ozone formation process.

[0146] Display interface 2208 (or other interface, such as user interface 402) forwards text, video graphics, and other data from communications infrastructure 2202 (or from a frame buffer (not shown)) for display on display unit 2214. For example, display interface 2208 may include a video card with a graphics processing unit, or may provide an operator with an interface for controlling the device.

[0147] The computer system 2200 may also include an input unit 2210, which an operator of the computer system 2200 may use together with the display unit 2214 to send information to the computer processor 2206. The input unit 2210 may include, for example, a touch screen monitor. In one example, the display unit 2214, the input unit 2210, and the computer processor 2206 may together form a user interface.

[0148] One or more steps of providing ozonated water to the ultrasonic scaler handpiece may be stored in the form of computer-readable program instructions on a non-transitory storage device. To execute the protocol, the computer processor 2206 loads the appropriate instructions stored on the storage device into memory and then executes the loaded instructions.

[0149] The computer system 2200 may also include a main memory 2204, which may be a random access memory ("RAM"), and may also include a secondary memory 2218. The secondary memory 2218 may include, for example, a hard disk drive 2220 and / or a removable storage drive 2222 (e.g., a floppy disk drive, a tape drive, an optical disk drive, a flash drive, etc.). The removable storage drive 2222 reads from and / or writes to a removable storage unit 2226 in a well-known manner. The removable storage unit 2226 may be, for example, a floppy disk, a tape, an optical disk, a flash memory device, etc., which can be written to and read from by the removable storage drive 2222. The removable storage unit 2226 may include a non-transitory computer-readable storage medium that stores computer-executable software instructions and / or data.

[0150] In other illustrative embodiments, the secondary storage 2218 may include other computer-readable media that store computer-executable programs or other instructions to be loaded into the computer system 2200. Such devices may include a removable storage unit 2228 and interface 2224 (e.g., a program cartridge and cartridge interface); a removable memory chip (e.g., an erasable programmable read-only memory (“EPROM”) or a programmable read-only memory (“PROM”)) and an associated memory slot; and other removable storage units 2228 and interfaces 2224 that allow software and data to be transferred from the removable storage unit 2228 to other parts of the computer system 2200.

[0151] The computer system 2200 may also include a communication interface 2212 that enables software and data to be transferred between the computer system 2200 and external devices. Such an interface may include a modem, a network interface (e.g., an Ethernet card or an IEEE 802.11 wireless LAN interface), a communication port (e.g., a universal serial bus ("USB") port or a port), Personal Computer Memory Card International Association ("PCMCIA") interface, Etc. Software and data transmitted via the communication interface 2212 may be in the form of signals, which may be electronic, electromagnetic, optical, or other signal types that can be transmitted and / or received by the communication interface 2212. The signals may be provided to the communication interface 2212 via a communication path 2216 (e.g., a channel). The communication path 2216 carries signals and may be implemented using wire or cable, optical fiber, a telephone line, a cellular link, a radio frequency ("RF") link, etc. The communication interface 2212 may be used to transmit software or data or other information between the computer system 2200 and a remote server or cloud-based storage device (not shown).

[0152] One or more computer programs or computer control logics may be stored in the main memory 2204 and / or the secondary memory 2218. The computer program may also be received via the communication interface 2212. The computer program includes computer executable instructions that, when executed by the computer processor 2206, cause the computer system 2200 to perform the methods described below. Thus, the computer program may control the computer system 2200 and other components of the aqueous ozone ultrasonic dental scaler system 100.

[0153] In another embodiment, the software may be stored in a non-transitory computer readable storage medium and loaded into the main memory 2204 and / or the secondary memory 2218 using the removable storage drive 2222, the hard disk drive 2220, and / or the communication interface 2212. When the control logic (software) is executed by the computer processor 2206, it causes the computer system 2200, and more generally, the device, to perform some or all of the methods described herein.

[0154] Finally, in another example embodiment, hardware components such as ASIC, FPGA, etc. may be used to perform the functions described herein. Based on this description, it will be clear to those skilled in the relevant art(s) to implement such a hardware arrangement to perform the functions described herein.

Claims

1. A method for providing ozonated water to an ultrasonic dental scaler handpiece, comprising: transporting water from a water source to an electrolytic cell of an aqueous ozone ultrasonic scaler system; delivering an electric current to the electrolytic cell to generate ozone gas in water delivered to the electrolytic cell; providing one or more recirculation loops in the fluid pathway to move water and generated ozone gas through the electrolytic cell and one or more gas separators disposed in the corresponding recirculation loops; separating gaseous ozone from a stream of ozonated water to be delivered to the ultrasonic scaler handpiece using the one or more gas separators; measuring the concentration of ozone in the water using one or more ultraviolet sensors by the amount of ultraviolet light absorbed by dissolved ozone in the water passing through a water column that is part of each of the one or more ultraviolet sensors, wherein the one or more ultraviolet sensors are disposed in the recirculation loop of the fluid pathway, and wherein the ozonated water stream passes from the electrolytic cell into a gas separator and then from the gas separator into the ultraviolet sensors; using the measured ozone concentration in the water to close-loop control the concentration level of generated ozone gas in the water delivered to the electrolytic cell by the amount of current delivered to the electrolytic cell to generate ozonated water having a defined concentration of dissolved ozone; and Ozonated water is delivered to the ultrasonic scaler.

2. The method of claim 1, further comprising providing one or more pumps to maintain a defined fluid level and pressure of the aqueous ozone ultrasonic scaler system to increase the solubility of the ozone gas in water.

3. The method of claim 1, wherein a proton conducting membrane is used in the electrolytic cell, and the method further comprises: In response to providing two or more recirculation loops, after a defined operating period and after verifying that the ozone gas in the water has decayed, the electrical polarity of the electrolytic cell is switched so that the side that was the cathode side in a previous operation of the aqueous ozone ultrasonic scaler system becomes the anode side in a current operation, and the other side that was the anode side in a previous operation of the aqueous ozone ultrasonic scaler system becomes the cathode side in a current operation to distribute membrane degradation on both sides of the electrolytic cell to extend the shelf life of the membrane of the electrolytic cell.

4. The method of claim 3, wherein the switching eliminates or substantially eliminates stagnant water and microbial contamination.

5. The method of claim 1, wherein the water delivered from the water source is deionized water or water obtained from reverse osmosis.

6. The method of claim 1, further comprising: An inlet baffle is used to slow the flow of ozonated water entering the one or more gas separators so as to substantially reduce overturning flow in the chamber of the one or more gas separators and prevent gas bubbles from being carried over to the outlet ports of the one or more gas separators.

7. An aqueous ozone ultrasonic scaler system for providing ozonated water to an ultrasonic scaler handpiece, comprising: Ultrasonic dental scaler handpiece; Electrolytic cell; a water source for delivering water to the electrolytic cell, wherein the electrolytic cell is connected to the water source via a fluid passage and is adapted to receive an electric current to generate ozone gas in the water to form ozonated water; one or more gas separators, wherein each gas separator is disposed in a corresponding recirculation loop of a fluid pathway also containing the electrolytic cell, each gas separator being configured to separate gaseous ozone from an ozonated water stream to be delivered to the ultrasonic scaler handpiece; one or more ultraviolet sensors disposed in the recirculation loop of the fluid pathway such that the ozonated water stream passes from the electrolytic cell into the gas separator and then from the gas separator into the ultraviolet sensors, and wherein the one or more ultraviolet sensors are adapted to measure the concentration of dissolved ozone in the water by the amount of ultraviolet light absorbed by dissolved ozone in the water passing through a water column that is part of each of the one or more ultraviolet sensors; and A processor, configured to cause the system to execute the method steps as described in any one of claims 1-6.

8. The system of claim 7, further comprising: One or more pumps are disposed in the fluid pathway to control the pressure of the system in at least a portion of the fluid pathway.

9. The system of claim 8, further comprising: One or more valves are disposed in the fluid pathway to release gas to control another pressure of the system in at least a portion of the fluid pathway.

10. The system of claim 7, further comprising: One or more level sensors connected to the one or more gas separators to measure the level of ozonated water in the gas separators.

11. The system of claim 7, further comprising: An ozone destroyer is disposed in the gas release path of one or more gas separators and is adapted to convert the separated gaseous ozone gas into oxygen.

12. The system of claim 7, wherein the water source is a spray bag or water bottle having a duckbill connection assembly to deliver water in a single direction.

13. The system of claim 7, wherein the water source is held in a loading tray in a base of the system.

14. The system of claim 7, wherein the polarity of the electrolytic ozone cell is switchable to reverse the side of the system that produces ozone gas.

15. The system of claim 7, further comprising: A light emitting diode (LED) light source and a detector photodiode are disposed at opposite ends of each of the one or more UV sensors, the LED light source being configured to project UV light to the detector photodiode to measure an amount of UV light absorbed by dissolved ozone, wherein a monitoring photodiode disposed near the LED light source is configured to measure changes in the output intensity of the LED light source to compensate for degradation of the LED light source over time.

16. The system of claim 12, wherein the spray bag or water bottle has a radio frequency identification (RFID) tag configured to be read to prevent reuse or use of an alternate water source that does not have the RFID tag.

17. A computer system for providing ozonated water to an ultrasonic scaler handpiece, comprising a processor configured to: transporting water from a water source to an electrolytic cell of an aqueous ozone ultrasonic scaler system; delivering an electric current to the electrolytic cell to generate ozone gas in water delivered to the electrolytic cell; providing one or more recirculation loops in the fluid pathway to move water and generated ozone gas through the electrolytic cell and one or more gas separators disposed in the corresponding recirculation loops; separating gaseous ozone from a stream of ozonated water to be delivered to the ultrasonic scaler handpiece using the one or more gas separators; measuring the concentration of ozone in the water using one or more ultraviolet sensors by the amount of ultraviolet light absorbed by dissolved ozone in the water passing through a water column that is part of each of the one or more ultraviolet sensors, wherein the one or more ultraviolet sensors are disposed in the recirculation loop of the fluid pathway, and wherein the ozonated water stream passes from the electrolytic cell into a gas separator and then from the gas separator into the ultraviolet sensors; using the measured ozone concentration in the water to close-loop control the concentration level of the generated ozone gas in the water delivered to the electrolytic cell by the amount of current delivered to the electrolytic cell to generate ozone water having a defined concentration of dissolved ozone; and Ozonated water is delivered to the ultrasonic scaler.

18. The computer system of claim 17, wherein the processor is further configured to perform the step of maintaining a defined fluid level and pressure of the aqueous ozone ultrasonic scaler system using one or more pumps to increase the solubility of ozone gas in water.

19. The computer system of claim 17, wherein a proton conducting membrane is used in the electrolytic cell, and wherein the processor is further configured to perform the following steps: In response to providing two or more recirculation loops, after a defined operating period and after verifying that the ozone gas in the water has decayed, the electrical polarity of the electrolytic cell is switched so that the side that was the cathode side in a previous operation of the aqueous ozone ultrasonic scaler system becomes the anode side in a current operation, and the other side that was the anode side in a previous operation of the aqueous ozone ultrasonic scaler system becomes the cathode side in a current operation to distribute membrane degradation on both sides of the electrolytic cell to extend the shelf life of the membrane of the electrolytic cell.

20. The computer system of claim 19, wherein the switching eliminates or substantially eliminates stagnant water and microbial contamination.

21. The computer system of claim 17, wherein the water delivered from the water source is deionized water or water obtained from reverse osmosis.

22. A non-transitory computer-readable storage medium storing a program, which, when executed by a computer system, causes the computer system to perform a process comprising the following steps: transporting water from a water source to an electrolytic cell of an aqueous ozone ultrasonic scaler system; delivering an electric current to the electrolytic cell to generate ozone gas in water delivered to the electrolytic cell; providing one or more recirculation loops in the fluid pathway to move water and generated ozone gas through the electrolytic cell and one or more gas separators disposed in the corresponding recirculation loops; separating gaseous ozone from a stream of ozonated water to be delivered to the ultrasonic scaler handpiece using the one or more gas separators; measuring the concentration of ozone in the water using one or more ultraviolet sensors by the amount of ultraviolet light absorbed by dissolved ozone in the water passing through a water column that is part of each of the one or more ultraviolet sensors, wherein the one or more ultraviolet sensors are disposed in the recirculation loop of the fluid pathway, and wherein the ozonated water stream passes from the electrolytic cell into a gas separator and then from the gas separator into the ultraviolet sensors; using the measured ozone concentration in the water to close-loop control the concentration level of the generated ozone gas in the water delivered to the electrolytic cell by the amount of current delivered to the electrolytic cell to generate ozone water having a defined concentration of dissolved ozone; and Ozonated water is delivered to the ultrasonic scaler.

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