Ultrasonic Scaler with Ozonated Water System

Abstract

The ultrasonic scaler features closed-system water delivery and an integrated in-line electrolytic ozone generator, gas separation, in-line dissolved gas monitoring and closed-loop control of ozone concentration.

Description

[Technical field]

[0001] The present application relates generally to methods, apparatus, computer systems, and computer readable storage media for aqueous ozone solution delivery, and more specifically to methods, apparatus, computer systems, and computer readable storage media for enabling an ultrasonic scaler to provide closed system aqueous ozone solution delivery. [Background technology]

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

[0003] Ozone decays with a typical half-life of 20 minutes, affecting the concentration of aqueous ozone solutions during transportation, filling, and use. Because the effectiveness of ozone decreases over time, clinicians must time ozone treatment and use for each scaling procedure.

[0004] Ozone can be produced by electrolytic cells. Conventional electrolytic cells aim to produce pure hydrogen and high pressures, thus requiring a very robust structure. This design goal means that they are not suitable for low-cost portable equipment. Furthermore, conventional electrolytic cells typically have very low levels of dissolved ozone in solution due to the need to avoid releasing excess gaseous ozone. Currently, there are no commercial small-scale electrolytic cells that can produce higher levels of controlled levels of dissolved ozone. Furthermore, time management is well known to be the most stressful part of a dentist's day. Waiting for equipment to start up and reach a charge is unacceptable. Conventional ozonation processes that use corona discharge to generate ozone gas from compressed oxygen or room air must form bubbles of ozone in the water. This can be achieved by a sparger or venturi that injects gas directly into the water line, and alternative system architectures that perform this gas dissolution under pressure may approach the fill rate of the electrolytic ozone generation architecture described in this disclosure, but are limited in their ability to generate and dissolve ozone with control and flux while maintaining a compact size. Methods used today to produce a batch of ozone in water are performed at or near 1 atmosphere (atm) and require as much as 20-30 minutes to fully load 1 liter of water with ozone to achieve clinically useful concentrations (e.g., 4 ppm).

[0005] Furthermore, the key to successful periodontal treatment and maintenance is the removal or reduction of pathogenic bacteria from the periodontal pocket and the formation of a microflora compatible with periodontal health. Current methods used for periodontal debridement include both power scalers and manual instruments. Modern techniques used for debridement rely primarily on the destruction of both hard and soft deposits. Soft deposits are formed primarily by microorganisms that attach to surfaces and grow composite structures composed of microbial cells and biopolymers (i.e., EPS, extracellular polymeric substances). Dysbiosis occurs when healthy homeostasis is altered and an imbalance of pathogenic bacteria takes hold. The goal of periodontal debridement is to restore gingival health by completely removing the elements that cause gingivitis (i.e., plaque, tartar, endotoxins). Proper periodontal treatment disrupts and removes plaque retention factors such as subgingival biofilm, endotoxins, and tartar. Modern periodontal treatment has the additional objectives of improving patient comfort, preserving tooth structure, creating a biologically acceptable root surface, and resolving inflammation.

[0006] Ultrasonic scalers combine acoustic energy and cavitation to excite the fluid surrounding the scaler tip to produce microstreaming, while providing both mechanical debridement and constant flushing with irrigation fluid directed at the surface being debrided. Scaling procedures utilize irrigation fluid to maintain safe operating temperatures of the scaler handpiece and tip, to wash away deposits and debris, and to provide a medium for coupling ultrasonic acoustic energy to the surrounding surfaces being cleaned.

[0007] Most ultrasonic scaling procedures utilize drinking water or water that has been treated to maintain the cleanliness of the scaling equipment and other water lines. Additionally, drugs may be used in periodontal debridement, suitable drugs include chlorhexidine, povidone-iodine, hydrogen peroxide, along with other mouthwashes and antibacterial agents. Each of these drugs has limited potency and toxicity depending on its concentration. Summary of the Invention

[0008] Exemplary embodiments provide devices, methods, systems, and computer readable media. In one aspect herein, an ultrasonic scaling device is provided that has the ability to generate an aqueous ozone solution on demand. The device may utilize an aqueous ozone solution rinse to facilitate removal of dental biofilm for debridement. The aqueous ozone solution is delivered to the oral cavity through an ultrasonic scaler handpiece and insert controlled by the system described herein. The goal is to deliver an effective and safe level of the aqueous ozone solution to improve clinical outcomes (e.g., bleeding on probing, clinical attachment loss, periodontal inflammation).

[0009] An exemplary embodiment is one in which ozone is effective in reducing the bacterial load in the oral microbiome, which has significant benefits for oral health and broader systemic health, including reduced risk of dental caries, gingivitis and periodontitis, halitosis, cardiovascular disease, stroke, hyperglycemia, and other diseases.

[0010] The exemplary embodiments also address a significant market barrier for ultrasonic scalers with the ability to generate and control the delivery of an ozone-water solution: clinics do not need to purchase a separate ozone generator in addition to the ultrasonic scaling unit, and clinics no longer need to ozonate water, transport it, and fill the ultrasonic scaler reservoir.

[0011] In one aspect herein, a method of providing ozonated water to an ultrasonic scaler handpiece is disclosed, the method including the steps of delivering water from a water supply to an electrolytic cell of an aqueous ozone ultrasonic scaler system, applying an electric current to the electrolytic cell to generate ozone gas in the water, providing one or more recirculation loops in a fluid path to move the 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 applied to the electrolytic cell to produce ozonated water having a specified concentration of dissolved ozone, and separating gaseous ozone from the stream of ozonated water delivered to the handpiece using the one or more gas separators.

[0012] In another aspect disclosed herein, the method includes any combination of the following: (i) further comprising the step of installing one or more pumps to maintain a prescribed fluid level and pressure in the aqueous ozone ultrasonic scaler system to enhance the solubility of ozone gas in water, and (ii) corresponding to the installation of two or more recirculation loops, a side of the aqueous ozone ultrasonic scaler system that was a cathode in a previous operation becomes an anode in the current operation and a side that was anode in the previous operation becomes an anode in the current operation to distribute membrane degradation resulting from the interaction of ozone gas with other oxidizing species from the electrolyzer across both sides of the electrolyzer to extend the life of the membrane of the electrolyzer (one or more membranes may be used. Each membrane is mechanically coupled with an electrode, thus using two membranes separates the electrodes to prevent the membrane from being subjected to high mechanical shear stress. In an exemplary embodiment, three or four or more membranes may be stacked). (iii) the switching step eliminates or substantially eliminates stagnant water and microbial contamination; (iv) the water delivered from the water supply is deionized water or water obtained from reverse osmosis (low conductivity water concentrates the current density at the three-phase boundary to improve ozone generation and prevent fouling by mineral deposits on the electrodes); and (v) the method further includes slowing down the flow of ozonated water entering the one or more gas separators using an inlet baffle to substantially reduce reverse flow in the chamber of the one or more gas separators and prevent air bubbles from being carried to the outlet port of the one or more gas separators. This further prevents air bubbles from entering the recirculation loop and eliminates air bubble interference with the optical ultraviolet absorbance ozone sensor.

[0013] In another aspect herein, an apparatus for supplying ozonated water to an ultrasonic scaler handpiece is disclosed, the apparatus comprising: a water supply for delivering water to an electrolytic cell of an aqueous ozone ultrasonic scaler, the electrolytic cell being connected to the water supply through a fluid path and adapted to receive an electrical current for generating ozone gas in the water to produce the ozonated water, one or more gas separators, each gas separator disposed in a corresponding recirculation loop of the fluid path that also contains the electrolytic cell, each gas separator configured to separate gaseous ozone from the flow of ozonated water delivered to the handpiece, and one or more ultraviolet sensors disposed in the recirculation loops of the fluid path, the ultraviolet sensors adapted to measure the concentration of dissolved ozone in the water by the amount of ultraviolet light absorbed by a portion of the water passing through the water.

[0014] In yet another aspect, the apparatus is disclosed in combination with one or more of the following features: (i) further comprising one or more pumps disposed in the fluid paths to control the apparatus pressure in at least a portion of the fluid paths, (ii) further comprising one or more valves disposed in the fluid paths to release gas to control another pressure of the apparatus in at least a portion of the fluid paths, (iii) 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, (iv) further comprising an ozone destructor disposed in the gas release path of the one or more gas separators and adapted to convert separated gaseous ozone gas to oxygen, (v) the water source is a spout pouch or water bottle having a duckbill connection assembly for unidirectional delivery of water, (vi) the water source is held in a loading tray in the base of the apparatus, and (vii) the polarity of the ozone electrolyzer is switchable to reverse the side of the apparatus that produces ozone gas.

[0015] In a further aspect, a computer system for supplying ozonated water to an ultrasonic scaler handpiece is disclosed, the computer system comprising a processor configured to execute the steps of delivering water from a water supply to an electrolytic cell of an aqueous ozone ultrasonic scaler system, applying an electric current to the electrolytic cell to generate ozone gas in the water, providing one or more recirculation loops in a fluid path to move the 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 applied to the electrolytic cell to produce ozonated water having a specified concentration of dissolved ozone, and separating gaseous ozone from the flow of ozonated water delivered to the handpiece using the one or more gas separators.

[0016] In yet another aspect, a non-transitory computer readable storage medium is disclosed that stores a program that, when executed by a computer system, causes the computer system to perform a procedure including delivering water from a water supply to an electrolytic cell of an ozone-water solution ultrasonic scaler system; applying an electric current to the electrolytic cell to generate ozone gas in the water; installing one or more recirculation loops in the fluid path to move the 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 applied to the electrolytic cell to produce ozonated water having a specified concentration of dissolved ozone as measured by ozone absorbance characteristics of ultraviolet light; and separating gaseous ozone from the stream of ozonated water delivered to a handpiece using the one or more gas separators.

[0017] A fully integrated system with in-line ozone / water solution generation allows for the generation and use of ozone / water solution in the treatment room when required for the procedure. Materials used in the fluid pathways / fluid lines for both the ozone / water solution generator and the scaler are controlled and designed to limit scavenging action, ensure material compatibility with dissolved ozone, control the concentration of cleaning fluid exiting the scaling instruments, and ensure the effectiveness and reliability of the equipment. By developing and integrating the ozone generator and ultrasonic scaler, misuse of ozone / water solution in existing scalers that are not compatible with ozone is prevented.

[0018] In one aspect herein, dental practitioners can use ultrasonic scaling units with or without the generation of an ozone-based solution, and by simply being able to turn off or reduce the ozone to maintain water line cleanliness, the clinician has control over the timing of the delivery of the ozone-based solution to the patient.

[0019] Specially conditioned water, different from municipal water, may be required to generate the ozone aqueous solution and achieve the associated clinical benefits. Water with various levels of bacterial flora and other forms different from the specially conditioned water may contain chemicals and / or additives. The specially conditioned water is packaged in 1 / 2 liter bottles, for example, corresponding to 2-4 patients. The water is delivered in a container with a dedicated fitting designed to mate with the scaler water interface and prevent refilling. By controlling the input water, the reliability of the system and the quality and effectiveness of the cleaning solution can be controlled.

[0020] In an exemplary embodiment, the system significantly improves periodontal clinical parameters (e.g., bleeding on probing (BOP), clinical attachment loss, etc.) compared to conventional debridement methods by combining the effectiveness of ultrasonic scaling with the antibacterial and antibiofilm properties of aqueous ozone solutions. Recolonization of cleaned pockets with a more beneficial flora is more likely the more completely the pathogenic population is removed. The goal of sustained periodontal treatment is to achieve a sustained microbiome shift in these areas from a pathogenic (dysbiotic) flora to a more beneficial population that is less harmful to the local tissues and can maintain a reasonable equilibrium with the host tissues and physiology. This results in reduced inflammation of the periodontal tissues and improved clinical parameters in patients being treated for gingivitis and periodontal disease than any other debridement method. The aqueous ozone solution combined with the ultrasonic scaler's mode of action (i.e., mechanical, cavitation, microstreaming, and flushing action of the irrigation solution) eradicates pathogenic bacteria and retards the formation of dysbiotic pathogenic subgingival biofilm and plaque more than any other method of debridement. The results may include significantly improved oral comfort, reduced gingival inflammation, and longer tooth retention. By scaling with aqueous ozone solution, the ozone reduces infectious aerosols from patient bacteria present in the oral cavity during ultrasonic scaling. Because the system does not come into contact with tap water and all fluids in the system are ozonated, biofilm formation in the system piping and water lines is inhibited, allowing the water lines of the ultrasonic scaling system to remain nearly sterile, i.e., less than 100 colony forming units (CFU), and in some cases as low as 5 CFU, when performing clinical procedures (e.g., scaling, SRP). Although there are now antimicrobial agents (e.g., chlorhexidine, hydrogen peroxide, sodium hypochlorite, povidone-iodine) and systems commercially available for delivering them to ultrasonic scaler cleaning solutions, the ozone and oxygen-infused water produced by this system that eradicates pathogenic bacteria is natural and contains no additives or chemicals.Aqueous ozone decomposes very rapidly into water and oxygen, does not remain active in the periodontal pocket, and has lower cytotoxicity than other antimicrobial agents. Aqueous ozone does not affect taste and does not cause color stains. By combining the primary modes of action of ultrasonic scalers (e.g., mechanical, acoustic microstreaming, cavitation, and flushing cleaning) with aqueous ozone, both hard and soft deposits can be ablated without adding any extra steps or adjunctive treatments. This combined technique eradicates pathogenic bacteria and destroys biofilms subgingivally without the need for additional treatments (e.g., adjunctive medications, hand instrumentation, subgingival air abrasion, etc.).

[0021] Thus, the exemplary embodiment shows that aqueous ozone (AO) is an advantageous option for delivering antimicrobial functionality in cleaning solutions, replacing the need for traditional antimicrobial additives. Ozone in solution is a broad-spectrum antimicrobial agent, capable of inactivating bacteria, fungi and viruses, to which resistance cannot develop. In addition, aqueous ozone accelerates biofilm removal, shortening scaling procedures or increasing the completeness of biofilm removal. The chemical action of aqueous ozone on biofilms increases the effective radius of action of scaling and also attacks biofilms that are physically inaccessible. As shown in the paper entitled "Effect of ozone on oral cells compared with established antimicrobials" by Karin C. Huth et al. (Eur J Oral Sci. 2006:Vol. 114, pp 435-440), aqueous ozone is highly effective in breaking down biofilms and killing microbial cells, yet has low toxicity to patient tissues. The entire contents of this document are incorporated herein by reference as if fully set forth herein.

[0022] The use of an aqueous ozone cleaning solution allows for reduced ultrasonic power with the same cleaning effect, resulting in less discomfort to the patient. Optimizing results with an aqueous ozone scaling method requires concerted control of parameters, and therefore an integrated scaler with ozone generation and delivery means is highly preferred. The system provides all the essential means to achieve an optimized, safe and effective ozone-assisted scaling treatment.

[0023] To readily identify the description of any particular element or act, the most significant digit in a reference number refers to the figure number in which that element is first introduced. Certain novel features which are believed to be characteristic of the invention are set forth in the appended claims. The invention itself, however, together with its preferred modes of use, further objects and advantages, will best be understood by reference to the following detailed description of illustrative embodiments when read in conjunction with the accompanying drawings. [Brief description of the drawings]

[0024] [Figure 1] FIG. 1 is a block diagram of a system according to one embodiment. [Diagram 2] FIG. 2 is a schematic diagram of an electrolytic cell according to one embodiment. [Figure 3A] FIG. 3A is a perspective view of an electrolytic cell according to one embodiment. [Figure 3B] FIG. 3B is a perspective view of an electrolytic cell according to one embodiment. [Figure 4] FIG. 4 is a block diagram of a system according to one embodiment. [Diagram 5] FIG. 5 is a graph according to one embodiment. [Figure 6A] FIG. 6A is a perspective view of an ultraviolet (UV) sensor according to one embodiment. [Figure 6B] FIG. 6B is a cross-sectional view of an ultraviolet (UV) sensor according to another embodiment. [Figure 6C] FIG. 3C is a perspective view of an ultraviolet (UV) sensor according to another embodiment. [Figure 7]FIG. 7 is a schematic diagram of a connection according to one embodiment. [Figure 8] FIG. 8 is a schematic diagram of a pouch and connections according to one embodiment. [Figure 9] FIG. 9 is a diagram illustrating interactions according to one embodiment. [Figure 10] FIG. 10 is a schematic diagram of a connection according to one embodiment. [Figure 11] FIG. 11 is a schematic diagram of a connection according to one embodiment. [Figure 12] FIG. 12 is a schematic diagram of a connection according to one embodiment. [Figure 13A] FIG. 13A is a diagram illustrating a flow pattern according to one embodiment. [Figure 13B] FIG. 13B is a diagram illustrating a flow pattern according to one embodiment. [Figure 13C] FIG. 13C illustrates a flow pattern according to one embodiment. [Figure 14] FIG. 14 is a diagram illustrating a system according to one embodiment. [Figure 15] FIG. 15 is a diagram illustrating a system according to one embodiment. [Figure 16] FIG. 16 is a diagram illustrating a system according to one embodiment. [Figure 17A] FIG. 17A illustrates an alternative configuration of a system according to one embodiment. [Figure 17B] FIG. 17B illustrates an alternative configuration of a system according to one embodiment. [Figure 17C] FIG. 17C illustrates an alternative configuration of a system according to one embodiment. [Figure 17D] FIG. 17D illustrates an alternative configuration of a system according to one embodiment. [Figure 18A] FIG. 18A illustrates an alternative configuration of a system according to one embodiment. [Figure 18B] FIG. 18B illustrates an alternative configuration of a system according to one embodiment. [Figure 18C] FIG. 18C illustrates an alternative configuration of a system according to one embodiment. [Figure 19A] FIG. 19A illustrates an alternative configuration of a system according to one embodiment. [Figure 19B] 20B illustrates an alternative configuration of the system according to one embodiment. [Figure 20A] FIG. 20A illustrates an alternative configuration of a system according to one embodiment. [Figure 20B] FIG. 20B illustrates an alternative configuration of a system according to one embodiment. [Figure 21] FIG. 21 is a flow chart illustrating a method according to one embodiment. [Figure 22] FIG. 22 illustrates a computer system according to one embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0025] Exemplary embodiments described herein are directed to an ultrasonic scaler having an aqueous ozone solution, the ultrasonic scaler including a water source, an electrolytic cell, a gas separator, an ozone destructor, a pump, and a handpiece, which are described below.

[0026] Systems and Equipment

[0027] FIG. 1 is a block diagram of an ozone aqueous solution ultrasonic scaler system 100 according to one embodiment. The system includes a water supply source 104 adapted to enable safe long-term operation of the system. In an exemplary embodiment, the water supply source is purified water, such as deionized water or water obtained from reverse osmosis, especially with negligible levels of multivalent metal ions. Any water composition with selected concentrations of dissolved carbon dioxide, or oxygen, or inert gases can be used in the proposed system. The water supply source 104 can be delivered in a package / water bottle / spout pouch 704, such as a 200ml to 1000ml package with fittings to ensure that water that may contaminate the tank or produce undesirable components (e.g., bromides from bromine, or prochlorite) during ozonation is not fed to the system. The ozone aqueous solution ultrasonic scaler system 100 has one, two, or more water supplies 104 attached. The system can automatically switch from one water source 104 to another water source 104 if the water source 104 (spout pouch 704) becomes empty during a treatment, thus preventing interruption of the clinician's treatment while treating a patient. The system alerts the clinician that the package is empty and needs to be replaced before starting a second treatment. The water source 104 has a fitting that prevents refilling. In an exemplary embodiment, the system identifies if the package has been refilled by looking for a connection force or reading an RFID label that prevents reuse and use of an alternative water source.

[0028] The aqueous ozone ultrasonic scaler system 100 further includes an electrolytic ozone bath 106 that oxidizes the water to form ozone in solution. Conventional baths also produce some oxygen as a by-product, which further enhances the usefulness of the produced water for targeted treatment of anaerobic organisms, but does not in any way diminish the value of the aqueous ozone (AO) solution for scaling purposes. The bath may also produce some hydrogen peroxide, and components of this solution are also beneficial for cleaning, bleaching, and antibacterial effects. In some instances, the synergistic effects of ozone and hydrogen peroxide are known and may be used advantageously by the system.

[0029] The system is able to change the ozone level in the system more rapidly at start-up by driving the electrolytic ozone reservoir 106 with more current than is required to maintain the proper level during run-time and idle times. At start-up, the system achieves a specified pressure by two means: the primary water pump 118c which fills and pressurizes the system with water, and the air pump 118a (or air pump 118b) which assists the primary water pump 118c on the gas side of the system to generate sufficient system operating pressure needed to push fluid to the scaler handpiece.

[0030] In an exemplary embodiment, the monitoring and control device allows for the production of a stable and known concentration of active species under the control of a user. Ozone is a strong oxidizing agent and the system must allow for automatic monitoring and control of the concentration produced to ensure safety and effectiveness.

[0031] The gas separator 116a, 116b separates gaseous ozone from the water stream delivered to the ultrasonic handpiece 108. Because gaseous ozone is irritating and does not beneficially enhance the effectiveness of scaling, the aqueous ozone ultrasonic scaler system 100 is adapted to deliver all of the ozone in solution to the instrument with minimal air bubble content. The system further includes a means for ensuring that the flow path within the system is sufficiently bubble-free to allow operation of components such as the ozone sensor or pump. Similarly, the system includes a means for separating gaseous hydrogen for removal from the cathode, thereby avoiding the need to have a hydrogen peroxide waste stream from the depolarized cathode. The system is adapted to separately optimize the flow conditions within the electrolytic ozone bath 106 from the flow requirements of the clinician. For example, a buffer volume within the gas separator is used to decouple the instantaneous flow rate within the bath from the delivery flow rate. The use of the buffer volume 134 and recirculation loop 132 allows for an internal flow rate that is greater than the net flow rate from inlet to outlet, allowing for independent flow rate variation according to requirements. In practice, this has the added benefit of providing a well-mixed system volume for accurate concentration measurement and control of delivery to the ultrasonic handpiece 108, and also allows for integration of the gas separator 116a, gas separator 116b, and in-line sensor 102 with faster response time than in a stagnant storage volume.

[0032] Additionally, the system includes means for controlling the water flow rate and ozone content to the handpiece in response to user control and setting preferences, along with meeting other requirements such as cooling or coupling of ultrasound to the target surface. The present disclosure contemplates dynamically controlled water flow and ozone levels in response to instrument parameters such as usage and power levels (e.g., if the tip is not in contact with the target surface, as inferred from the ultrasound parameters, the excitation power may be instantaneously reduced, and the water flow may be reduced as well). When "active" scaling occurs, both power and water flow may be instantly increased by the control system. The adaptive behavior may provide the system with the advantage of high availability and may reduce the need to operate manual controls. Additionally, the system contemplates controlling the system operating pressure to operate the system at a higher pressure, dissolving more ozone in the production loop, providing water at sufficient pressure to operate standard scaling instruments, and enabling the use of existing equipment. Additionally, pressure may be controlled to provide a pressure signal that may be used as part of a flow control method, for example, when filling the system and to control the exhaust of gases generated by electrolysis. In a further embodiment, the system can be adjusted to operate at one of several different pressure settings, and the electrolyzer operating point can be adapted to compensate for the amount of gas dissolved at the different pressures.

[0033] An ozone destructor 114 is further used to neutralize any undesirable ozone released by the system, for example as part of the gas separation function. Also, a means to manage any associated hydrogen release from the cathode of the electrolyzer. Hydrogen can be oxidized back to water within the electrolyzer itself, or within a separate component optimized for that function, or in conjunction with the reduction of excess ozone. The ultrasonic handpiece 108 is adapted to function with high effectiveness in conjunction with an ozone-rich cleaning solution. Adaptations may include, for example, coatings that enhance compatibility of the handpiece with the ozone solution, ultrasonic exciters with low heat output, sensing devices that connect to the drive unit, recirculating water flow options, or dual-flow designs using regular water for cooling and basic cleaning, and on-demand ozonated cleaning solution delivered directly to the tip only.

[0034] Additionally, the system includes a user interface 402, physical interfaces to a water supply (not shown) and handpiece, and suitable casework to optimally adapt the system to the needs of the dentist and the safety and effectiveness of the associated procedure. In a first embodiment, the system functions very similarly to conventional non-ozonating ultrasonic scalers, allowing experienced users to immediately use the new system in established procedures. The integration of control of ultrasonic and ozone generation functions is a beneficial feature of the proposed embodiment.

[0035] The system is inherently safe and has several properties that provide both safety and effectiveness by design. Thus, the system delivers an ozone-water solution and no gaseous ozone is delivered to the patient. The flow rate of the ozone-water solution is limited by the system's low pressure, flow control, and the orifice of the ultrasonic scaler insert. Ozone production is inherently safe and controlled by Faraday's law of electrolysis, where gas production is directly proportional to current. As a result, 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 the ozone-water solution, and the ozone generator 122 can be configured not to operate or not produce ozone gas in the absence of water. The UV sensor 110 directly monitors the level of ozone in the water. The Faraday control establishes a safe operating region so that the bath drive parameters can provide both control and monitoring of the bath condition, since the current and resulting bath voltage are what drive the electrochemical reaction. The system ozonates high purity water delivered in a custom container with dedicated connections, providing control over both the quality and composition of the input water contained in the ozonated cleaning solution. It is different from other systems that attempt to ozonate tap water or dissolve gases generated from room air by corona discharge. The safety of the cleaning solution is controlled by the input water, the ozone compatible materials used to construct the system, and a gas separator that prevents gases and entrained gases from being delivered to the ultrasonic scaler handpiece. Excess ozone gas is neutralized by conversion to oxygen (O2) via an ozone destructor, preventing the intentional release of ozone into the local environment from the gas release path 146. Protection against unwanted emissions (i.e., leakage) of ozone from the system is provided by robust tubing, fittings, and components (i.e., pumps and valves). The system controls prevent ultrasonic operation when the system state is not ready to deliver cleaning solution (i.e., the fresh water source is empty, the target ozone level is not met, the system pressure is not achieved, or a fault is detected).

[0036] Having briefly described the components of the aqueous ozone ultrasonic scaler system 100, said components will now be described in more detail.

[0037] In an exemplary embodiment, the water supply 104 is preconditioned in individual packages as shown in Figures 17-19. The packages are rendered sterile by suitable sterile connections (not shown) to the system. To ensure continuity of supply during treatment, the system allows for the use of multiple (e.g., two) containers and is adapted to switch between containers if the first container is empty during treatment. In an exemplary embodiment, the system determines that the correct water package has been inserted to ensure safe and optimal operation of the system.

[0038] In another exemplary embodiment, real-time purified water from a drinking water source is taken, as shown in FIG. 15. Here, a separate purification supply or an integrated purification device is used to purify the tap water 1504. The purification supply system includes a water quality sensor to ensure accurate operation for safe supply of the electrolyzer. If an external purification device is used, a small secondary purification stage may be included with the specific function of removing residual traces of ions such as Fe, Cu, Zn, or Al, which have a high affinity for the membrane and are known to promote the membrane degradation process. In particular, the integrated water purification mechanism can use conventional reverse osmosis / deionization technology, or preferably, a self-regenerating deionization technology such as electrodeionization, which can take the standard drinking water / non-ozonated water supply and generate purified water with sufficient flux for the average usage rate of the system. An intermediate water reservoir may be used to allow buffering between peak and average demand, although the system will occupy more space. Tap water 1504 is typically available at a specified pressure, which can be used to facilitate an initial filtration step in the purification process, thereby reducing the need to include a separate pump in the system just for this purpose. In addition to the bottle feed configuration, the system is adapted to allow operation from a piped water source, allowing the operator to select non-ozonation operation at any time and avoid depleting the pure water source when not actually needed. It is not preferred to use a piped water source with the electrolytic ozone generator unless it is filtered and deionized. The piped water source is delivered through a bypass water line that has its own control over water pressure and a separate water solenoid to enable and disable water discharge to the handpiece, without going through the ozone generator 122 portion of the system. The system can further be designed to have no external connection for the piped water, but still include a bypass line that draws water from the bottle feed configuration and delivers it directly to the handpiece without ozonation.Non-ozonation operations can also be delivered through the ozone generator 122 portion of the system by turning off the current to the electrolytic ozone tank 106, and the tank current can also be operated at a significantly lower level or infrequently pulsed with the current required to generate ozone, resulting in undetectable levels of ozone being delivered to maintain the cleanliness of the water lines within the system.

[0039] 2 is a schematic of an electrolytic cell according to one embodiment. Electrochemical ozone production by direct oxidation of water, instead of the formation of 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. Although the chemistry of the catalytic surface affects the rate of ozone production, 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.

[0040] The goal is to achieve the fastest possible oxygen generation rate (and therefore hydrogen production rate) at the lowest achievable cell voltage, as this directly impacts the energy cost of the process. While much of the electrolysis is done directly with a conductive electrolyte carrying the current between the electrodes, a membrane 202 (proton conducting membrane) can be used to carry the proton current but not allow other species to pass at a significant rate. This allows the electrolysis of pure water to be achieved, with notable advantages in chemical simplicity and the absence of undesirable by-products. The membrane 202 can be a sulfonated derivative of Teflon, such as Nafion, Aquivion, and similar products. These cells are usually called proton exchange membrane water electrolyzers (PEMWE). For example, PEMWE industrial electrolyzers in the so-called "Membrel" process for oxygen / hydrogen production can have a long service life. However, when the cell voltage is increased and ozone selective catalysts are used, the achievable service life becomes significantly shorter due to degradation of the membrane and electrodes in the extremely oxidizing environment, especially due to several free radical mediated reactions that effectively attack the membrane polymer.

[0041] By selectively producing ozone instead of oxygen, hydrogen is generated as a waste product. The goal of the aqueous ozone ultrasonic scaler system 100 is to achieve a combination of high dissolved ozone concentration and long useful life of the bath, and electrodes of boron-doped diamond (BDD) can be used to take advantage of the preferential ratio of ozone formation to oxygen formation in this material. However, BDD as a material presents some practical challenges since it is essentially equivalent to diamond in terms of mechanical properties and must be fabricated by directly synthesizing a doped diamond layer on a suitable substrate to form a layer of controlled conductivity. Thus, BDD electrodes are relatively expensive and fragile components. In an exemplary embodiment, the electrolytic ozone bath 106 comprises a pair of perforated silicon plates with a thin boron-doped diamond coating, a layer of proton-conducting membrane 202 between the silicon plates, and a flow path 204 for water and evolved gases to pass through the perforated surface. This configuration provides the necessary three-phase boundary area at the edges of all the holes in the plate. Of course, other similar configurations can be realized in light of this specification. The examples in this disclosure are used only for clarity of explanation and are not limited to the exemplary embodiments. Additional acts, behaviors, tasks, activities, and operations are contemplated from this disclosure and are contemplated within the scope of the exemplary embodiments.

[0042] 3A is a perspective view of a first configuration of the electrolytic ozone cell 106 according to one embodiment. In this configuration, the flow channels 204 are arranged parallel to the membrane 202.

[0043] FIG. 3B is a perspective view of another configuration of the electrolytic ozone cell 106 according to one embodiment, where the flow channels 204 are oriented perpendicular to the membrane 202.

[0044] 4 is a block diagram of 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 bath 106, the ultrasonic handpiece 108, the UV sensor 110, the solenoid 128, the foot pedal 130, the user interface 402, the ultrasonic control board 404, the ozone system main control board 406, the power supply 408, the sensor 410, and the pump 412. Some or all of the components of the aqueous ozone ultrasonic scaler system 100 of FIG. 1. 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 interactions 400 in the aqueous ozone ultrasonic scaler system 100.

[0045] FIG. 6A is a perspective view of a UV sensor 110 according to one embodiment.

[0046] The UV sensor 110 comprises an LED 602 ​​with temperature sensor, a mount 604 to allow for the addition of a lens, a lid 606 that holds mounting points for the optical and electronic elements to allow for easy removal and maintenance, the lid 606 provides heat dissipation, a monitor photodiode (off-axis) 608 to allow compensation for LED output / intensity that changes over time, the monitor photodiode 608 has a temperature sensor, and a step window 610 made of sapphire to allow for light transmission, resistance to chemicals, and mechanical toughness with minimal flow voids. The UV sensor 110 further includes a temperature sensor hole 612 to allow for thermal expansion if necessary, an anodized aluminum tube 614 that is threaded, for example, male-threaded, to apply pressure to the window that holds the optical elements and the printed circuit board (PCB), a measurement photodiode (on-axis) 616 (detector) with a temperature sensor to allow compensation for photodiode (PD) sensitivity changes with temperature, routing grommets 618, a Kynar polyvinylidene fluoride (PVDF) block manifold 620 to ensure optical path accuracy and ease of integration, and an input Kynar barb fitting 622 to receive water whose ozone levels are to be measured, which is discharged through an output Kynar barb fitting 624.

[0047] The ozone aqueous solution ultrasonic scaler system 100 is configured to directly measure ozone in water by measuring the absorbance of ultraviolet light to maintain both safety and efficacy. The UV sensor 110 operates on the principle of light absorption and utilizes an ultraviolet light emitting diode (UV LED). As shown in FIG. 5, light is strongly absorbed by ozone in the ultraviolet region around 280 nm. A 280 nm LED may be selected because it is less expensive than a 260 nm LED (where 260 nm is the absorption peak) and still absorbs well enough to be detectable. Of course, the selection is not limited to a 280 nm LED.

[0048] The optical spectrum of ozone absorbance is shown in Figure 5. The sensor for measuring dissolved ozone exploits this phenomenon. Its principle is the absorption of light by ozone. For example, the more ozone produced, the smaller 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 it passes.

number

[0049] The light projected through the water column is represented as a voltage V at the output of the amplifier of the detector (measurement photodiode (on-axis) 616). V0 is the voltage from the detector when there is nothing to absorb or scatter the light. This is proportional to the temperature T of the LED. ledIt depends on the LED brightness, which changes with temperature. The system continuously monitors two parameters: the output from the LED and the temperature of the LED. σ[λ] is the absorption cross section (unit area). V is the signal voltage representing the detected light. Because the detector voltage depends on its temperature, the UV sensor 110 can measure and compensate for temperature effects. Its value depends on the LED wavelength λ, which changes with temperature changes. This change is predictable and can be compensated for using additional circuitry and software. x[λ] is the optical path length, which is the distance light travels through water containing dissolved ozone. The optical path length / absorption cross section can change with temperature changes due to material expansion. This change is minimized by material selection and the drift is compensated for or simply accepted. These values ​​can vary from unit to unit and therefore can be corrected by using a calibration method as part of the final test procedure in manufacturing, where the calibration is done using a known "concentration" of dissolved ozone to provide a value for the combined constant (-σ.x). This value is called the "calibration constant." The system can compensate for temperature-induced changes by knowing how this constant changes with temperature and adjusting it with the ambient temperature during operation. Losses are caused by window contamination or anything that gets in the way of the light. This can be evaluated as a more frequent 0 test if pure water is present in flow path x. It is assumed that there are no significant absorbers at this wavelength, and experiments have shown that peroxides, for example, do not have much of an effect at this wavelength. During system startup (e.g., daily), catholyte from the previous day is circulated through the UV sensor, the catholyte is ozone-free and serves as a reference fluid to null any errors associated with the optical path (i.e., residues, surface buildup that reflect and absorb photons that offset the ozone measurement). To reduce LED heating and eliminate "dark current," the LED is pulsed and measured in both "on" and "off" states. The pulse lasts, for example, about 3 ms "on" and 3 ms "off," and can be as short as 200 microseconds or as long as 10 seconds.The timing is software controlled, but additional circuit elements can provide hardware-based pulsation with picosecond repeatability and precision. Each flash's "on" value has a corresponding "off" value subtracted from it (allowing removal of transient illumination fluctuations), and the resulting value is averaged over 100 flashes, or 10 or so flashes, or over 100,000 flashes.

[0050] The use of light is a non-contact approach to measuring dissolved ozone and avoids the introduction of contaminants into water pipelines associated with electrolytic ozone sensors that must come into contact with the water.

[0051] FIG. 6B illustrates a UV sensor 110 according to another exemplary embodiment. The UV sensor 110 may be configured to have an outer housing that allows it to fit into the manifold (not shown) of the ozone aqueous ultrasonic scaler system 100. A number of manifold attachment points 642 allow the sensor to be attached to the manifold. The UV sensor 110 includes a monitor photodiode (off-axis) 608 for monitoring the intensity of light projected by the UV LED 626. A measurement photodiode (on-axis) 616 is located on the projection axis and configured to measure the amount of return UV light indicative of the concentration of ozone in the water passing from the fluid port 636 through the water column 634. A collimating lens 628 collimates the UV light toward the measurement photodiode (on-axis) 616. The measurement photodiode (on-axis) 616 is coupled to a housing 640 and connected to the flexible circuit 630 such that movement of the flexible circuit 630, for example during manufacturing, does not displace the measurement photodiode (on-axis) 616 off-axis. The flexible circuit ideally has on-board electrical connections 638 that allow for the introduction of power, analog signals, temperature, and digital communication lines from external / main control circuitry to the UV sensor 110, allowing for local measurements and calculations that prevent or substantially eliminate noise that occurs in sensors that do not have local measurement and calculation capabilities.

[0052] 6C, multiple UV sensors 110 are combined in an infinite number of configurations, with each sensor configured to be used during a corresponding switching configuration of the electrolytic ozone bath 106, for example, one UV sensor 110 may be used during an anode / cathode configuration and a different UV sensor 110 may be used when switched to a cathode / anode configuration by reversing the polarity of the electrolytic ozone bath 106. The rigid PCB 644 may be a subpart of the flexible circuit 630.

[0053] Integrating an ozone water solution generator with closed loop control of ozone concentration into an ultrasonic dental scaler requires the reduction of key components and incorporation into the fluid manifold. The UV sensor 110 used to monitor the concentration of ozone is a key component required in the catholyte and anolyte on both sides of the system to support daily polarity switching. Two small sensors or a single sensor with two channels is required. An alternative approach involves using four three-way valves to bypass the recirculating water loop through the sensors, with the valves switching depending on which side of the system is generating ozone.

[0054] As ozone is produced in the electrolytic bath, its production can be increased or decreased based on the level of DC current flowing into the bath. Information provided by the UV sensor provides a control loop with a measurement of the ozone concentration in the water being recirculated in the system. The aqueous ozone solution travels from the bath to a gas separator, which then travels from the gas separator to the UV sensor. The gas separator ensures that the water flowing through the UV sensor does not contain air bubbles, which would block the light in the UV sensor and create noise in the measurement. Static air bubbles that form in the fluid path while the system is off must be flushed away from the UV sensor. To achieve a clear water column, the fluid channels through the system are designed to reduce flow velocity and avoid eddy currents and voids that prevent air bubbles from being carried away by the flow.

[0055] The manifold-compatible UV sensor has two fluid ports that are connected to the manifold upon assembly of the UV sensor to the manifold. An interface seal between the body of the UV sensor and the manifold forms the fluid connection. Water flows out of the manifold, into the UV sensor, and back from the UV sensor to the manifold. The fluid path is oriented to avoid trapping air bubbles, therefore, it is preferred to place the UV sensor at the bottom of the manifold so that gravity can assist in flushing of air bubbles. The sapphire window sections at each end of the water column must be exposed to the fluid flow so that air bubbles and debris are easily removed by the flow of water through the sensor. Mounting the sensor to the bottom of the manifold more easily supports incorporation into an ultrasonic scaler by designing a low-profile sensor that aids in the need to minimize the scaler height, a requirement for installation in a dental treatment room.

[0056] The manifold-compatible UV sensor 110 can be designed for ease of assembly. It provides a sealed fluid path that allows UV light to pass through to the water column 634. At both ends of the water column 634 are electro-optical elements aligned to optimize the signal-to-noise ratio. Mounting the UV LED 626 and the measurement photodiode (on-axis) 616 on the flexible circuit 630 mechanically isolates these electro-optical elements from any rigid PCB that integrates all the electronics to control the LEDs, power and amplify the photodiode, digitize, and analyze the analog photodiode signal. The sensor circuit includes a microprocessor that processes an algorithm that uses the analog voltages from the detection and monitoring photodiodes along with calibration and loss values ​​to calculate the ozone concentration. By maintaining a local microprocessor, the ozone concentration can be digitally transferred, for example, via an I2C bus to a central microprocessor responsible for controlling the entire ozone water solution system, the ultrasonic scaler, and the user interface. By processing the analog signal close to the photodiode, the possibility of electrical noise coupling is reduced, since 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 designed with a full integration of both analog signal processing, analog-to-digital conversion, calculation, and digitization of ozone concentration further simplifies factory calibration routines. The UV sensor 110 can be calibrated and stocked as a finished module. The ultrasonic scaler provides DC power and a connection via an I2C bus to access the 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 modular approach directly supports product servicing, since the sensor can be swapped out without the need for calibration once installed in the ozone water solution ultrasonic scaler 706.

[0057] Returning to FIG. 1, gas separator 116a and gas separator 116b are further described. In the aqueous ozone ultrasonic scaler system 100, there is a gas headspace that is in equilibrium with the ozone-containing water. Gas bubbles are generated at the anode side 124 due to the localized generation of high gas concentrations at the anode side 124. The gas bubbles coalesce in the flow to form a headspace 136, and generally, this headspace 136 in a well-mixed system is in near equilibrium with the water. It is important to control the headspace 136 and the volume of entrained gas at any outlet. Conventional ozone treatment systems use a venturi to dissolve ozone gas in the water flowing through the pipe, but this approach does not prevent undissolved gas from migrating to the dental handpiece, and does not support systems that use low flow rates below 40 ml / min, typically below 20 ml / min, because these flows do not have the energy (fluid velocity and volume) to generate adequate ozone concentrations by drawing gas into the flow path.

[0058] As part of the optimized flow system, a bubble-free portion of the flow is directed to the exhaust of the flow system to the ultrasonic handpiece 108 in response to a user request. It is also possible to perform some buffering or averaging of both ozone concentration fluctuations and system pressure fluctuations. Additionally, the pump operates most efficiently when there are no air bubbles. Air bubbles are present in the flow system when the ozone generating tank is operating, and thus by continuously separating the air bubbles from the flow, a bubble-free ultrasonic scaling cleaning solution is produced and gases that escape the cleaning solution are prevented from entering the patient's oral cavity. At a minimum, this gas separator further provides a buffer reservoir for the ozonated water, a buffer volume for the gas headspace 136, an area for water level sensing, and connection points for multiple gas and water connections. In an exemplary embodiment, the following functions are combined in a single aqueous ozone solution ultrasonic scaler system 100: (i) The ability to use multiple recirculation loops 132 and corresponding gas separators, such as two recirculation loops 132, each with a gas separator separating a volume of water, so that the polarity of the system can be alternated to provide rapid generation of the ozone solution and extend the life of the electrolytic ozone bath 106 (a gas separator 116a on the anode side 124 of the electrolytic ozone bath 106 may be in use while another gas separator 116b on the cathode side 126 may not be in use, and a polarity switch can be made so that the gas separator 116b that was on the cathode side 126 is now on the anode side 124 and therefore ready to operate). Polarity switching can occur, for example, daily, to keep the bath healthy to maintain good performance, i.e., the ability to reach a target concentration in a short time (e.g., 30 seconds) and maintain that concentration during scaling. During scaling, the water in the system is constantly diluted as the ozone solution leaves the handpiece and fresh water is pumped into the system. To maintain the level in the separator, the ozone concentration is diluted and the EO tank must be turned on to maintain the concentration. Another important reason for polarity switching is to eliminate the need for daily system flushing, which takes time and wastes water.Without daily flushing (for example) of the catholyte water, the system would not be emptied or replaced. Polarity switching ensures that the catholyte side is switched to the anolyte side and then the water is ozonated and replaced during scaling. (ii) providing an ultrasonic scaling cleaning solution that is free of air bubbles and removing entrained gas from the gas separator outlet to prevent gas from escaping from the cleaning solution into the patient's mouth, (iii) providing a purified water sample to the UV sensor 110 (air bubbles reflect and diffract UV light resulting in erroneous signal measurements. The performance of the electrolytic ozone bath 106 is enhanced by the purified water sample, although the light attenuation signal generated by air bubbles may be averaged out), (iv) providing pressure smoothing in the circuit, (v) controlling the concentration at the outlet by controlling the electrolytic ozone bath 106. (vi) extending the timescale of the control circuit (reducing bandwidth); (vii) making the bath flow parameters of the electrolytic ozone bath 106 independent from the exhaust flow of ozonated water to the ultrasonic handpiece 108 through the use of a controlled exhaust of a gas separator; (viii) providing a headspace 136 for separation and collection of excess gas from the system; (ix) smoothing out system pressure fluctuations; and (x) isolating the water reservoir from the headspace connection (e.g., to the ozone destructor 114).

[0059] The system topology combines flow through with an internal recirculation loop 132 to match the separate flow conditions required for optimal electrolysis ozone bath 106 and ozonated water delivery. The bath operates best in near steady state with high water flow rates across the electrode plates for both thermal and gas bubble transport reasons. The exhaust flow must respond to user control and can be highly intermittent.

[0060] Air bubbles have a natural rise velocity in water, and to allow flotation to efficiently remove air bubbles from the stream, there must be a portion of the stream with a free surface whose residence time is longer than the maximum rise time of the air bubbles to the surface. The maximum rise time is a function of the air bubble size and the height the air bubbles must rise to before reaching the surface. In an exemplary 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 as not to cause turbulent entrainment of additional gas from the headspace into the liquid. The liquid level is managed by the system by using a water level sensor, such as sensor 102, to maintain a non-entrained condition during normal operation.

[0061] In another exemplary embodiment, the flow path from the electrolytic ozone bath 106 to the separator maximizes bubble coalescence and minimizes bubble breakup to ensure the average bubble size is as large as possible. Larger bubbles rise faster, allowing for better separator performance or the use of a smaller separator working volume.

[0062] In another exemplary embodiment, the inflow of water into the separator is obstructed and regulated to minimize jetting and reduce the magnitude of turbulent eddies in the inflow region, as described below.

[0063] In another exemplary embodiment, the liquid volume of the separator is provided with baffles spaced apart to suppress large amounts of reverse flow in the chamber, thus reducing the possibility of relatively low energy circulation currents carrying air bubbles downwards towards the outlet port. The inlet and baffle design is such as to create as much uniform slow downward moving flow as possible over the entire area of ​​the chamber. The vortex in the flow should be smaller than the baffle spacing, which can be adapted to suit the chamber shape and the placement of the inlet and outlet ports.

[0064] The separator chamber is characterized by a cross-sectional area that satisfies the following relationships: (i) bubble rise time < residence time of the water in the reservoir, (ii) bubble rise velocity (relative to the target diameter cutoff) > downward average velocity of the flow 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 (a balance is maintained between bubble removal and mixing of the fresh ozonated water with the separator volume being diluted by fresh input water). If bubbles coming out of the recirculation loop input stream are allowed to penetrate the entire volume of liquid in the separator, there is a high probability that they will be drawn into the recirculation loop exit port or into the fluid discharge port. Thus, the bubbles are directed towards the gas-fluid interface so that they are released into the gas side and do not enter the discharge line or re-enter the recirculation loop. The flow The inlet flow is directed towards the free surface, suppressing countercirculation that would carry the air bubbles into the water; (v) the diameter of the vortex in the chamber is set by the lateral dimensions of the flow solution. Subdivision of the volume should be made to limit the vortex size and therefore the penetration depth of the air bubbles; (vi) the average flow velocity in the chamber is less than the rising velocity of the smallest air bubble that needs to be removed; (vii) the velocity fluctuations throughout the chamber are as low as possible, i.e., the velocity fluctuations are approximated to a laminar plug flow profile; (viii) the exit points from the chamber (especially the exit points of the delivery channel) are placed where the possibility of excessive downward flow velocity is minimized. This minimizes the risk of air bubbles reaching the exit points; (ix) the exit flow ports are shielded to draw flow relatively uniformly from the entire area of ​​the chamber.

[0065] Chambers that meet the above conceptual design rules can be cylindrical or rectangular in cross section. The cross section can have an aspect ratio (height / width)>1, preferably an aspect ratio (height / width)>2. Subdivision of the chamber can be of different shapes (e.g., but not limited to, square or circular or hexagonal) without affecting the function, and the separation element can extend from the base of the chamber to the free surface or slightly away from the free surface. The height of the gas headspace 136 above the free water surface is determined by other factors and can vary widely without affecting the bubble separation function of the water volume. For use with ozone treatment solutions, preferably all wetted surfaces are composed of ozone inert materials such as fluoropolymers, or substrates coated with protective layers that do not significantly react with ozone. A level sensing means such as sensor 102 can be associated with the chamber. The structure of the chamber can be adapted to allow level sensing, for example by capacitive or other depth sensors integrated into the chamber, without affecting the function.

[0066] The combination of a compressible gas volume in fluid connection with the reservoir volume 138 results in the smoothing of pressure pulses in the circuit connected to that volume. In this system, this smoothing action is applied to the inflow flow from the air pump 118a (or air pump 118b), the recirculation flow through the reservoir volume 138, and the outflow flow to the outlet 140. Given the applicable criteria for acceptable pressure pulses in any of these flows, and the presence of known pressure pulsation sources (e.g., pumps or valves), the volumes of fluid and gas in the chambers can be adapted to provide the necessary filtering of pressure fluctuations versus time. The specific values ​​of the volumes required also depend on the inertance of the associated pipe flows and the elasticity of the pipes. In the exemplary embodiment, the pipes have negligible elasticity, and the optimization of the pressure smoothing is derived by calculation of the flow inertance and the chamber volumes.

[0067] The gas separator provides a reservoir volume 138 of aqueous ozone solution to draw from during the scaling procedure, rather than drawing flow directly from the electrolytic ozone bath 106. The system may use a control set point for the ozone level in the chamber that is efficiently circulated and mixed by recirculation through the bath separately from the exhaust flow. Thus, an ozone sensor control loop may be implemented without risk of error due to uneven flow patterns through the sensing element, or variable ozone decomposition during periods of low or no flow through the sensor. Having a reservoir of aqueous ozone solution minimizes fluctuations in the ozone level exiting the ultrasonic handpiece and decouples the exhaust flow rate from the instantaneous operating parameters of the electrolytic ozone bath 106 or the instantaneous operation of the driving pump. As the fluid dispensed as the aqueous ozone solution ultrasonic cleaning solution exits the system via the ultrasonic handpiece 108, it must be replenished. To maintain the water level in the separator, fresh water enters the system to supplement the exhaust flow. Fresh water mixes with the fluid in the separator and recirculation loop to produce some diluent that is collected by the electrolytic bath 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 it is not necessary to compensate for every momentary variation in the operating conditions, as these are inevitably smoothed out by the mixing process in the chamber and flow loop.

[0068] Due to the volume of the separator, the system needs to fill this volume of water at start-up before the desired ozone concentration is reached. The target concentration level can be achieved by driving a specific current for a period of time (e.g., 500 mA for 2 minutes) or by using a closed loop controller that monitors a UV sensor to determine the level of dissolved ozone in the separator and recirculation path.

[0069] To increase the efficiency of the electrolytic ozone cell 106, the bubbles formed at the cell three-phase boundary are separated from the electrode surface so as not to reduce the effective working area. To achieve this, the recirculation flow and the electrolytic cell flow channels are adjusted for high flow rates at this surface. If the exhaust flow passes directly through the cell to the exhaust, even with an intervening buffer volume, it is not possible to completely determine the instantaneous operating conditions in the cell, since the cell velocity varies with the exhaust flow demand, and a corresponding flow rate adjustment of the cathode side flow rate is required to maintain the desired pressure balance across the electrode membrane assembly. This dynamic adjustment of both flow paths places a severe control burden on the entire system. Moreover, below a threshold flow rate, either cell heating or failure to remove bubbles is a risk, and furthermore, the cell current needs to be adjusted according to the instantaneous exhaust ozone level as well as the temperature limit of the electrode assembly at even lower flow rates. The system solves many of these problems simultaneously by providing cross flow paths and using a gas separator component as an element that allows a combination of flow paths to be implemented and meet all of the system requirements. The recirculation flow rate between the reservoir volume 138 and the electrolytic ozone bath 106 can be set separately to optimize bath operating conditions for high flow rate and stable conditions, while still allowing the electrolytic bath flow channels to provide make-up and drain flows with appropriate flow and pressure characteristics.

[0070] There is a significant pressure drop in the electrolytic-ozone bath 106 when operated with high flow rates and narrow flow paths. The system design creates this pressure drop inside the recirculation loop, but does not affect the apparent pressure drop in the flow-through path. Thus, the system can be optimized further than if the separate pressure requirements were both applied to a common flow path. In an exemplary embodiment, the average operating pressure of the system, as represented by the gas separator, is set to the operating pressure of an attached instrument, such as the ultrasonic handpiece 108. The additional pressure required to drive the flow to the electrolytic-ozone bath 106 does not occur in series with this operating pressure, but only in the connection between the recirculation pump and the electrolytic-ozone bath 106.

[0071] The inlet 142 to the gas separator(s) greatly reduces jet turbulence, allowing the main volume of the gas separator to operate with a gentle flow pattern through the use of an inlet baffle 1304 that immediately diffuses the flow as shown in FIG. 13A. The combination of the inlet baffle 1304 and the tube row 1314 slows and controls the flow into the separator. The challenge is to slow the jet velocity from the velocity in the inlet pipe, over a short distance. Simply increasing the diameter is ineffective due to flow separation and non-uniform velocity profiles. Even a gradually tapered expansion does not prevent this mixing. The basic concept combines an obstacle that diverts the jet into a radial flow to prevent separation, followed by a "stacked" section packed with thin tubes to restrict the plug flow to a slow average velocity. Testing has shown that a 1 cm diameter works easily up to 1000 ml / min. As seen in Figure 13B, most of the air bubbles escape at the surface 1302, and the chamber baffle 1308 suppresses the overall countercirculation, causing the air bubbles to rise faster than the downward water flow 1306. As shown in Figure 13C, a solid center section 1312 of the integral tube 1310 prevents surface disturbances from affecting the sensor 102. The integral tube 1310 has openings on one side at the top and bottom for equilibration of the water and gas levels level with the central region.

[0072] For all bubbles of interest, the average downward water velocity is slower than the upward bubble velocity, allowing the bubbles to escape into the headspace. Since small bubbles rise much slower than larger bubbles, the critical diameter can be found by equating the water velocity with the upward velocity using established relationships.

[0073] In a non-limiting embodiment, for very small bubbles, the velocity of the bubble is given by the Hadamard / Rybcynski relationship: for a bubble between 0.2 and 2 mm, velocity V=ρ.gd 2 / 12.μ, an alternative formula is V(m / sec)=120×d(m), where ρ is the density of the fluid, g is the acceleration of gravity, d is the bubble diameter, and μ is the dynamic viscosity of the liquid.

[0074] Furthermore, for very small bubbles, there is a regular relationship between size and velocity, and between the effects of temperature and ionic strength on velocity, however the effects of temperature and ionic strength can be quite small.

[0075] The analysis gives example values ​​for the equivalent area of ​​a 3 cm diameter separator (the actual internal diameter is 3.3 cm, subtracting the inlet tube area gives this net area for flow).

[0076] Flow rate = 500 ml / min = 8.33 ml / sec. Area = 7.1 cm2, downward flow velocity is about 1.2 cm / sec. Bubble size at Vrise = 1.2 cm / sec is about 100-140 μm. If the separator flow is uniform, all bubbles larger than about 100 μm will escape. This impairs separation performance, since the high-velocity jet inlet flow will move the circulating vortices much faster than the mean flow. There is not enough volume for the turbulent flow to dissipate energy. With a quiet inlet, and some further plug-flow forcing baffles in the main chamber, one can aim for separation performance close to theory in the same chamber volume.

[0077] Further exemplary embodiments to enhance performance include a larger diameter flow spreader above the inlet, for example about 15 mm, and the addition of a "jet baffle" at the inlet. Also, larger stacked tubes in the inlet to reduce bubble breakup, and smaller diameter (e.g., about 5 mm) tube packing in the main chamber volume to further dampen vortices. It is expected that the inlet flow will not be able to "bypass" the packing and reach the recirculation outlet.

[0078] To deliver the aqueous ozone solution to the ultrasonic handpiece 108, the system pressure requirement (which may range from 15 psi (approximately 103.42 KPa) to 40 psi (approximately 275.79 KPa), but more typically 22 psi (approximately 151.68 KPa)) is determined by the pressure required to generate an output flow rate of approximately 65 ml / min or less, but more typically 25 ml / min. Some ultrasonic inserts are designed with small fluid paths through the insert tip. These fluid paths may be less than 0.020 inches (approximately 0.050 cm), and typically less than 0.15 inches (approximately 0.038 cm). System pressure also affects the rate of gas dissolution of ozone, which is an important factor to consider in order to quickly fill the system to the desired concentration upon start-up. Pressure is generated in the system by pumps (air pump, primary water pump) and gas generated by the electrolytic ozone tank 106. The air pump is used primarily during start-up, during periods of high flow discharge that may require additional input to maintain system pressure to deliver a continuous flow, and may also be used to purge the ozone water solution ultrasonic scaler system 100 for long term storage and shipping where water is not stored in the gas separator. The primary water pump 118c fills the system and gas separator and also adds fluid to the system while the system is operating at a system pressure of about 22 psi (about 151.68 KPa), but may range from 15 psi (about 103.42 KPa) to 40 psi (about 275.79 KPa), for example, and may operate below 15 psi (about 103.42 KPa) and above 40 psi (about 275.79 KPa). As the electrolytic ozone bath 106 adds gas to the system, the system pressure continues to rise, so that the system pressure may be controlled by pressure regulation. It is electronically controlled via a valve 120 that is opened and closed by software based on input from a pressure transducer. In an exemplary embodiment, gas in the buffer volume 134 may be released by two valves 120 in series, the first valve opens to vent a small amount and then closes, and the second valve 120 opens to vent a small amount through an ozone destroyer 114 that converts the ozone gas to oxygen gas. This valve switching prevents a sudden drop in system pressure.A mechanical method to limit and control system pressure is to release gas in the separator headspace via a pressure relief valve. The pressure relief valve utilizes a seal and spring pressure, opening and venting only when the system pressure exceeds the pressure on the seal created by the spring force. The pressure relief valve, with its fast action and very low mechanical hysteresis, provides a stable level of system pressure. A pressure transducer can be used in conjunction with the system pump to increase the system pressure to support the desired discharge flow rate and gas solubility. In addition to these pressure control means, there is a level sensor 102 that maintains the fluid level in the separator. By maintaining the proper fluid level, the gas headspace volume is controlled and rapid changes in headspace volume that would affect the system pressure are prevented. A significant advantage of the ozone water solution ultrasonic scaler system 100 architecture over conventional water ozonation systems is that it has the ability to go from no dissolved ozone to a full fill state in less than three minutes, for example, and potentially achieve a full fill in less than 30 seconds.

[0079] In using the aqueous ozone ultrasonic scaler system 100, the following steps may take place: The gas side air pump 118a is turned on to charge the system pressure. Water from the closed vessel is pumped into the system until the level sensors 102 reach their preset volumes. In an exemplary embodiment, these steps occur in less than 10 seconds, which may reach the preset volumes in less than 2 seconds, raising the system fluid and operating pressures to their desired levels. (The fluid level in the system is required to add enough volume to the gas separator to fill the fluid paths and create the water reservoir and gas headspace. The gas separator may be filled with water, for example, 20% to 80%, or typically 40% to 60%, or just above the baffles in the gas separator, in an exemplary embodiment. The pressure in the system rises from approximately 0 psi. Some pressure is added to the system by pumping water to reduce the gas volume, but a vent solenoid valve typically helps open to fill the system with water more quickly. Once the desired water level is reached, the air pump is turned on to quickly charge the system pressure to 15 psi (about 103.42 KPa) to 40 psi (about 275.79 KPa), typically 22 psi (about 151.68 KPa).) At this point, the system recirculation pump is turned on and drive current is provided to the electrolytic ozone tank 106. In an exemplary embodiment, the electrolytic ozone bath 106 may be powered at 1.1 to 7 times its normal operating current during initial charging of the aqueous ozone ultrasonic scaler system 100 to allow for rapid system charging. The recirculation pump may also be operated at a higher duty cycle or voltage, increasing the recirculation rate, to help rapidly draw gas from the electrolytic bath so that small bubbles are rapidly swept away from the three-phase boundary at the bath membrane-electrode interface. These small bubbles form a larger surface area compared to larger bubbles formed from small bubbles that coalesce at the surface of the bath three-phase boundary or from delayed release. Gas from the electrolytic ozone bath 106 is dissolved in the recirculating water more rapidly due to the higher system operating pressure.The solubility of ozone in water depends on the temperature of the water, the concentration of dissolved ozone gas, and the pressure in the system including the recirculating water and ozone gas. Higher pressure equals higher dissolved ozone levels. In an exemplary embodiment, by operating at 20 psi (approximately 137.89 KPa) to 24 psi (approximately 165.47 KPa) above one atmosphere, more than twice the amount of ozone can be dissolved in the system water. Entrained gas is separated from the recirculation loop and then routed through the UV sensor 110. The UV sensor 110 monitors the start-up routine and allows the closed loop controller to achieve a steady state condition that returns both the electrolytic ozone bath 106 and the recirculation pump to normal power levels. Reliability and bath membrane life are improved by limiting the higher current to the bath and motor to only the start-up sequence. At start-up, the dental clinician can immediately begin filling the ultrasonic handpiece 108 with water to prime the system, and can also begin scaling or rinsing with the ultrasonic insert. However, this may slow the overall charge time or require the tank to draw more power to achieve a fast charge due to the additional dilution with fresh water entering the system.

[0080] In another exemplary embodiment, the aqueous ozone scaler system 100 is designed so that both the cathode side 126 and the anode side 124 are symmetrical or substantially symmetrical. The cathode and anode gas separators are then identical or substantially identical in size, structure, volume, and their ability to separate gas bubbles from the fluid. In an exemplary embodiment, both sides have a dissolved ozone sensor, for example, each side has a UV sensor 110 (FIG. 14), where one UV sensor 110 can measure two separate fluid paths, each belonging to one side, or one UV sensor 110 has a series of shutoff valves that can redirect any flow path of the system through the UV sensor to provide the system with the ability to monitor ozone gas in either recirculation loop 132. The ability to simultaneously or alternately measure ozone gas in both recirculation loops 132 can add self-diagnosis. By monitoring both sides, a decision can be made to keep the anode as the anode, or if the ozone level is acceptably low (e.g., less than about 0.2 ppm or undetectable), the system can reverse polarity. The software of the ozone aqueous ultrasonic scaler system 100 changes the polarity to the electrolytic ozone tank 106, for example, via an H-bridge, to generate a discharge flow from the outlet 140 on either side of the system that is producing ozone. Another advantage of monitoring the ozone levels at both the anode and cathode is to monitor gas crossover. Ozone in the cathode recirculation loop can indicate an early sign of tank membrane perforation or loss of fluid and / or gas seal. This type of self-diagnosis can help both to alleviate safety concerns as well as to warn the end user prior to loss of functionality or performance.

[0081] The need to switch system polarity arises from the need to maintain critical system properties related to fluid level and reliability in the catholyte. During operation, water molecules are drawn through the membrane 202 by electro-osmosis. Over time, the gas separator 116b will increase its fluid level (catholyte volume increases as water moves from the anode to the cathode via electro-osmosis or from fluid leakage inside the EO cell). Without a drain or reason to drain from the cathode side of the system, the gas separator 116b will fill up and eventually need to be drained. By switching the polarity of the entire system daily, for example, a slight increase in fluid level from a day of use is easily managed. The reliability requirement for polarity switching arises from the long-term performance goals of the electrolyzer and the need to maintain the cleanliness of the water in the catholyte without requiring special start-up or shutdown process steps. An extra maintenance step is undesirable because it requires extra time or requires a drain line to be installed or conveniently located. Ultrasonic scalers are typically placed on a countertop, in a cabinet, or in a special drawer designed for surgical instruments. However, these locations do not have access to a drain, and therefore the system requires a waste receptacle to collect the catholyte water at the end of the day. Alternatively, the clinician must remove the fluid from the system to a surgical sink by running a special purge cycle. The purge cycle operates a maintenance pump, a small diaphragm air pump, which pushes water out of the system and into the handpiece by opening a water solenoid. During this purge cycle, water is dispensed into a nearby sink or small reservoir. During this purge, there is a risk that ozone gas stored in the headspace will also be released from the handpiece. This would result in unwanted exposure to ozone gas. To avoid this exposure and the need to run special purge cycles, which are inconvenient and require additional setup time, systems that can change polarity daily automatically refresh and ozone the previous day's catholyte side of the system.

[0082] The water on the cathode side of the system is not used during scaling and must be periodically replaced through additional setup or shutdown steps. This water can be replaced through a purge process requiring a small air pump that can move the water from the cathode side of the system to a waste container, into a drain, or transferred through a valve to the ultrasonic handpiece 108. These options may require special cathode purge steps during startup or shutdown of the ultrasonic scaler. During the scaling procedure, water is transferred by a pump from a pure water source, for example, a custom closed water packaging system (e.g., spout pouch 704) designed with tamper-proof features and custom fittings. The water travels through the anode side 124 of the system and ozone is dissolved in the water, which is then delivered to the ultrasonic handpiece 108 as a cooling wash fluid for both the transducer and the ultrasonic scaler tip. At startup, the cathode separator (gas separator 116b) is filled with an appropriate amount of water that is recirculated through the cathode side of the electrolytic ozone tank 106 for the reduction reaction.

[0083] Alternatively, the cathode and anode can be switched, for example, daily. During off times when the system is not in use, for example 12 to 16 hours, the ozone naturally decays and the half-life of the ozone-water solution is typically about 20 minutes, avoiding any concerns from the effects of crossover gas. Once the ozone has decayed to about 0.5 ppm or less, the risk of reverse chemical reactions at the three-phase boundary of the electrolytic ozone tank 106 is minimized. The system can safely change the polarity of the tank by switching the electrical polarity of the tank. Software prompts this polarity change so that the ozone-water solution is pumped out by opening the appropriate solenoid valve. By changing the polarity, the remaining cathode water from the previous day is recirculated through the electrolytic ozone tank 106 at its positive or oxidizing anode side 124. As the remaining anode water from the previous day naturally decays, the ozone in the corresponding separator reverts back to oxygen and this water is recirculated through the cathode, which is the reducing side of the tank. Both separators require fluid lines and solenoid valves capable of delivering water to the ultrasonic handpiece 108. By switching polarity each day only after verifying that the ozone level has decayed, the bath can alternate between its anode and cathode, helping to limit fouling from deposits that typically deposit on the cathode electrode. Membrane fouling resulting from the interaction of ozone with other oxidizing species (HO, HO, HO, HO, etc.) can be distributed on both sides of the bath, extending the life of each membrane. Additionally, the catholyte is replaced daily and each side of the system is ozonated to prevent stagnant water and eliminate or substantially eliminate the possibility of microbial contamination. Of course, other configurations that prevent stagnant water, reduce ozone exposure, and extend the life of the membrane 202 can be realized in light of this specification. The examples in this disclosure are used only for clarity of explanation and are not limited to the exemplary embodiments. Additional actions, behaviors, tasks, activities, and operations are contemplated from this disclosure and are contemplated within the scope of the exemplary embodiments.

[0084] Additionally, optical methods that utilize the UV absorbance of ozone to detect levels of dissolved ozone in water may require offset correction to account for changes in the mechanism and light path (i.e. debris, aging of the UV source).By changing the polarity on the system daily, the previous day's cathode water, water with dissolved hydrogen, can be used to null any sensor offsets and correction can be performed without the variable concentration of absorbing components in the water.

[0085] Ozone gas is known to cause respiratory irritation, therefore, exemplary embodiments incorporate controls on ozone concentration and limits on ozone production to prevent the patient from inhaling ozone gas. The emitted ozone from the system comes entirely from the delivered water stream. Any headspace gaseous ozone from the gas separator is catalytically destroyed before being released into the local environment.

[0086] One concern with scaling with ozonated irrigations is intraoral gassing (dissolved ozone diffusing from the irrigation solution naturally creates a localized environment) within the oral cavity that must be maintained. A risk of exposure can arise during the scaling procedure if the ozonated water delivered to the patient's oral cavity accumulates and outgassing before being evacuated from the oral cavity by the clinician.

[0087] By fully incorporating ozone generation and control within the ultrasonic scaler electronics, ozone gas exposure can be mitigated during a single treatment providing an ozone control system with specific mechanisms for limiting ozone gas exposure by monitoring the use of the system. Ultrasonic scaler parameters that can affect the amount of ozone gas released into the oral cavity include, but are not limited to, the flow rate of the irrigation fluid, the ultrasonic power level, the duty cycle of the scaling procedure, and the type of suction used, i.e., high volume exhaust and / or saliva ejector.

[0088] The ozone concentration directly determines the amount of ozone available in the cleaning solution. For patients with healthy gums, the clinician may choose to use a lower concentration of ozone, a level only necessary to inhibit biofilm growth in the system water lines, such as 0.020 ppm to 1.0 ppm, more typically 0.5 ppm. For patients with gingivitis or periodontal disease, higher concentrations may be selected by the user, 1.2 ppm to 3.0 ppm, and 3.0 ppm to 6.0 ppm, respectively.

[0089] The control system may operate using a real-time clock, allowing the scaler to track usage. Total scaling time per patient may be displayed and automatically reset after periods of non-use (typically 30 minutes to 1 hour). This usage data may also be used to monitor the total amount of ozone produced and dispensed over a period of time. The system may automatically reduce ozone concentration if a long scaling period at high concentrations is reached. As an example, a scaling time of more than 45 minutes at 3.0 ppm to 6.0 ppm may be determined to have reached safe exposure limits for the patient.

[0090] To ensure the use of suction, the system may include an ultrasonic microphone. The ultrasonic microphone has the ability to detect acoustic emissions due to the use of suction. If the system is unable to detect the use of suction, the system may prevent the clinician from delivering a higher concentration of ozone. The ultrasonic microphone may be located near the handpiece by placing the ultrasonic microphone in the handpiece cable. The housing of the system may include several ultrasonic microphones to provide omnidirectional detection capabilities. The ultrasonic microphone may be trained on the sound of a particular operating room saliva ejector suction and high volume exhaust. Alternatively, the system may be preprogrammed to identify both weak and adequate suction, allowing for higher concentrations if selected by the clinician. High volume exhaust can remove both fluid and gas with a typical flow rate of 200 LPM to 250 LPM (liters per minute), and this level of suction eliminates the risk of the patient inhaling ozone that has escaped from the ultrasonic cleaning solution before being aspirated from the oral cavity.

[0091] The complete integration of the ultrasonic scaler electronics and the ozone control circuitry allows for the formation of a control loop that takes into account rectified diffusion and rapid decomposition. Rectified diffusion is the result of acoustic energy shearing dissolved gases from solution when the oscillating sound waves cause bubble formation. These bubbles expand and compress with the sound waves moving through the solution, and gas can diffuse into these bubbles to prevent the bubbles from collapsing, essentially liberating the dissolved gases. These small bubbles can flow through the handpiece and exit the tip of the ultrasonic handpiece 108. Since rectified diffusion can add to the release of ozone gas in the oral cavity, the concentration of ozone used 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 to oxygen due to mechanical excitation, in which case the system can increase the ozone concentration to help maintain the appropriate ozone level in the irrigation solution so that the ozone reaches the periodontal pocket.

[0092] Ultrasonic scalers use irrigation fluid to cool both the transducer and the ultrasonic scaler tip. The flow rate of the ultrasonic scaler can be adjusted by the clinician, but typical flow rates are 15 ml / min to 25 ml / min, and the system can operate at low flow rates, e.g., 2 ml / min to 5 ml / min, at the low end of the flow, and high flow rates, e.g., 30 ml / min to 45 ml / min, at the high end of the flow.

[0093] In an exemplary embodiment, the gas separator 116a or gas separator 116b provides a fluid level that can be monitored using non-contact fluid level sensing, e.g., capacitive or optical methods. By monitoring the level of fluid in the anode separator, the flow rate of fluid exiting the system can be calculated. The system typically operates under a pressure of 22 psi (about 151.68 KPa). When the exhaust solenoid is opened, the pressure built up in the system pushes water through the flow controller, through the open exhaust solenoid, into the cable of the ultrasonic handpiece 108, and into the handpiece, where it eventually exits the irrigation port on the insert of the ultrasonic handpiece 108. The flow controller is a mechanical device that cannot directly communicate with the system electronics. Alternative flow controllers can be operated via proportional valves, servo-controlled valves, servo-controlled mechanical regulators, or simply by adjusting the system internal operating pressure. When the clinician adjusts the mechanical flow controller located at the handpiece and handpiece cable interface, the rate of decrease in the anode separator volume can be detected. During the period when the primary pump fills the anode separator, the system software may recognize that it will not calculate water usage. During the fill time, the level sensor may further be used to determine if the primary pump is operating properly and if the water container has emptied. If the water container is empty, the primary pump cannot fill the anode separator. A timer is set to indicate a sufficient time for the pump to raise the level in the anode separator, for example, 50 milliseconds to 10 seconds. If a leak occurs due to a failure on either the gas or fluid side of the system, ozone gas may be released into the operating room. The system may recognize a sudden drop in system pressure that disables the generation of ozone and the delivery of ultrasonic scaling output. Additionally, the aqueous ozone solution ultrasonic scaler system 100 may have an internal gaseous ozone gas monitor 112 that automatically stops the aqueous ozone solution generation if the internal (inside the system housing) gaseous ozone level exceeds 100 ppb.Further, in an exemplary embodiment, all fluid paths in the device are closed except where the ozonated water exits the insert tip for delivery to the patient's oral cavity.

[0094] In yet another alternative embodiment, two water packages / water sources 104 (e.g., spout pouch 704) provide the added convenience of not interrupting a dental procedure if one package becomes empty as shown in FIG. 15. The system can sense when a package becomes empty and automatically switch using the ozone system main control board 406, for example, a sensor may sense a lack of fluid flow, an inability to raise the level in the separator, or simply a loss of fluid. Additionally, the motor current may be monitored to identify the presence or absence of fluid in the pump. The use of two pressure relief valves (pressure relief valve B 1602 and pressure relief valve A 1604) in FIG. 16 ensures that hydrogen and oxygen gases do not mix on the gas side, protecting the membrane from crossover gas reactions that may limit its useful life.

[0095] 7 is a schematic diagram of a connection assembly 702 according to one embodiment. The connection assembly 702 is incorporated into a water supply 104, such as a spout pouch 704 (also shown in FIG. 8), for connection to an aqueous ozone solution ultrasonic scaler 706.

[0096] 9 is a diagram illustrating an interaction according to one embodiment, including step 902 where the overcap is removed from the aqueous ozone ultrasonic scaler 706, step 904 where the spout pouch 704 is inserted into the overcap, and step 906 where the overcap is reinserted into the aqueous ozone ultrasonic scaler 706.

[0097] 10 is a schematic diagram of a timeline of a connection assembly 702 according to one embodiment, before connection 1002 and after connection 1004. In the exemplary embodiment, the connection assembly 702 includes a duckbill 1006 that forms a no-refill port, a dental instrument connector 1008 for connecting to the aqueous ozone ultrasonic scaler 706, an O-ring 1010 that forms a seal to block leaks, and a foil seal 1012 that is pierced upon insertion as shown after connection 1004.

[0098] 11 is another view of the connection assembly 702 according to one embodiment, further comprising a duckbill valve 1102 that houses the duckbill 1006. The assembly is connected by an ultrasonic weld / snap / glue 1104.

[0099] 12 is a more detailed exploded view of the connection assembly 702. The connection assembly 702 includes the dental instrument connector 1008, the foil seal 1012, the duckbill valve 1102, the spout body 1202, and the spout cap 1204.

[0100] 17A illustrates an alternative configuration of an ozone aqueous solution ultrasonic scaler 706 (ozone aqueous solution ultrasonic scaler configuration A1702) according to one embodiment. The ozone aqueous solution ultrasonic scaler configuration A1702 includes two water supply sources 104 in a series configuration configured such that the ozone aqueous solution ultrasonic scaler 706 has a narrow profile. The ozone aqueous solution ultrasonic scaler configuration A1702 further includes a level status 1708 that indicates the level of liquid water in the water supply sources 104.

[0101] FIG. 17B illustrates an alternative configuration of an ozone aqueous solution ultrasonic scaler 706 (ozone aqueous solution ultrasonic scaler configuration B1704) according to one embodiment, the alternative configuration having two water sources 104 in a parallel configuration configured such that the ozone aqueous solution ultrasonic scaler 706 has a wide profile.

[0102] 17C illustrates an alternative configuration of the aqueous ozone ultrasonic scaler 706 (aqueous ozone ultrasonic scaler configuration C1706) according to one embodiment. In this embodiment, the spout pouch 704 is stored in a compartment 1712 below the user interface 1710.

[0103] FIG. 17D shows a further exemplary shape of the water supply 104 including a plastic spout pouch 1714 , a carton 1716 and a bottle 1718 .

[0104] Figure 18A (ozone aqueous ultrasonic scaler configuration D 1802) and Figure 18B (ozone aqueous ultrasonic scaler configuration E 1804) show another alternative configuration of the system in which plastic spout pouches 1714 and cartons are used in a side-by-side configuration to produce a scaler having a wider profile as opposed to the narrower profile scaler of Figure 18C (ozone aqueous ultrasonic scaler configuration F 1806). In any of the configurations described herein, the ultrasonic handpiece 108 can be a magnetically coupled handpiece (double-sided) 1808 that is attached to the base of the scaler by magnetic means.

[0105] 19A and 19B further show an alternative configuration of the aqueous ozone solution ultrasonic scaler configuration C1706 having a compartment 1712 that contains a water source as a carton 1716 or bottle 1718.

[0106] In yet another exemplary embodiment, FIG. 20A shows a configuration having a base 2002 and a removable interface 2004, while FIG. 20B shows a loading tray having a handpiece holding port 2006 and lighting 2008 in the compartment 1712 area.

[0107] method

[0108] Referring now to FIG. 21, a process 2100 according to an exemplary embodiment will be described. The process 2100 begins by delivering deionized water from the water supply 104, as shown in step 2102. In step 2104, the water is pumped through a pump, such as the primary water pump 118c, to maintain the fluid level and achieve sufficient pressure to increase gas solubility and ultimately push the water to the handpiece. In step 2106, the water is moved through an electrolytic cell, such as the electrolytic ozone cell 106, in a recirculation loop using the corresponding pumps (e.g., air pump 118a and air pump 118b) in the recirculation loop. In step 2108, electrolysis produces oxygen and ozone gases on the anode side and hydrogen gas on the cathode side. In the next step, step 2110, the entrained gases are dissolved in the water and excess gases are separated from the recirculated water. The excess gases are exhausted through the ozone destructor 114 using a valve 120, such as a pressure relief valve. In step 2112, a prescribed ozone level is maintained, for example, to maintain the water line (approximately 0.5 ppm) or to achieve clinical efficacy (4 ppm to 6 ppm) by controlling the amount of current supplied to the electrolytic ozone bath 106. Step 2114 includes monitoring the ozone concentration in the fluid path 144 using the UV sensor 110 and controlling the production of ozone by adjusting the production by electrolysis. Multiple UV sensors 110 may be used, for example, one UV sensor per polarity configuration (polarity switch). In step 2116, the flow of the aqueous ozone solution from the pressurized system to the ultrasonic handpiece 108 is controlled using a water solenoid valve as the pump(s) maintain the prescribed fluid level and system pressure. Additionally, the aqueous ozone solution ultrasonic scaler system 100 is configured to control the safety and efficacy of the system in step 2118, for example, by reporting the status of the water level or in response to a user request for aqueous ozone solution. The process 2100 then ends (step 2120).

[0109] Computer Systems

[0110] Having described the apparatus, reference is now made to Figure 22, which is a block diagram of a computer system 2200 that may be used in accordance with at least some of the exemplary embodiments herein. Although various embodiments may be described herein with respect to this exemplary computer system 2200, after reading this description, it may become apparent to one of ordinary skill in the art how to implement the present disclosure using other computer systems and / or architectures.

[0111] In one exemplary embodiment herein, at least some components of the ozone aqueous ultrasonic scaler system 100, such as the ultrasonic control board 404 and the ozone system main control board 406, may form or be included in the computer system 2200 of FIG. 22. The 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"). The computer processor 2206 may be connected to a communication infrastructure 2202 (e.g., a communication bus, a crossover bar device, a network). In an exemplary embodiment herein, the computer processor 2206 includes a CPU that controls the timing of the electrolytic ozone bath 106 and the ozone formation process.

[0112] The display interface 2208 (or other interface, such as the user interface 402) transfers text, video graphics, and other data from the communications infrastructure 2202 (or from a frame buffer (not shown)) for display on the display unit 2214. For example, the display interface 2208 may include a video card with a graphics processing unit, or may provide an interface for an operator to control the device.

[0113] The computer system 2200 further includes an input unit 2210 that may be used in conjunction with the display unit 2214 by an operator of the computer system 2200 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 collectively form a user interface.

[0114] The step or steps of supplying ozonated water to the ultrasonic scaler handpiece may be stored in a non-transitory storage device in the form of computer readable program instructions. To perform a procedure, the processor 2206 loads the appropriate instructions stored in the storage device into memory and then executes the loaded instructions.

[0115] The computer system 2200 further comprises a main memory 2204, which may be 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 magnetic tape drive, an optical disk drive, a flash memory 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 magnetic tape, an optical disk, a flash memory device, etc., which can be written to and read 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.

[0116] In further exemplary embodiments, secondary memory 2218 may include other computer-readable media that store computer-executable programs or other instructions that are loaded into computer system 2200. Such devices may include removable storage units 2228 and interfaces 2224 (e.g., program cartridges and cartridge interfaces), removable memory chips (e.g., erasable programmable read-only memory ("EPROM") or programmable read-only memory ("PROM") and associated memory sockets, 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 portions of computer system 2200.

[0117] The computer system 2200 may further include a communications interface 2212 that allows for the transfer of software and data between the computer system 2200 and external devices. Such interfaces may include a modem, a network interface (e.g., an Ethernet card, or an IEEE 802.11 wireless LAN interface), a communications port (e.g., a Universal Serial Bus ("USB") port or a FireWire® port), a PC Memory Card International Association ("PCMCIA") interface, Bluetooth®, and the like. The software and data transferred via the communications interface 2212 may be in the form of signals (which may be electronic, electromagnetic, optical, or another type of signal) that may be capable of being transmitted and / or received by the communications interface 2212. The signals may be provided to the communications interface 2212 via a communications path 2216 (e.g., a channel). The communications path 2216 carries the signals and may be implemented using wire or cable, optical fiber, telephone line, cellular link, radio frequency ("RF") link, and the like. Communications interface 2212 may be used to transfer software or data or other information between computer system 2200 and a remote server or cloud-based storage (not shown).

[0118] One or more computer programs or computer control logic may be stored in the main memory 2204 and / or the secondary memory 2218. The computer programs may further be received via the communications interface 2212. The computer programs include 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 programs may control the computer system 2200 and other components of the aqueous ozone ultrasonic scaler system 100.

[0119] In another embodiment, the software may be stored on 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. The control logic (software), when executed by the computer processor 2206, causes the computer system 2200, and more particularly the device, to perform some or all of the methods described herein.

[0120] Finally, in another exemplary embodiment, hardware components such as ASICs, FPGAs, etc. may be used to perform the functions described herein. The implementation of such hardware components to perform the functions described herein will be apparent to one of ordinary skill in the art(s) from this description.

Claims

1. 1. A method for supplying ozonated water to an ultrasonic scaler handpiece, comprising: delivering water from a water supply to an electrolytic cell of the aqueous ozone ultrasonic scaler system; applying an electric current to the electrolytic cell to generate ozone gas in the water; providing two or more recirculation loops in a fluid path for moving the water and ozone gas through the electrolytic cell and two or more gas separators corresponding to each of the two or more recirculation loops; controlling the level of ozone gas concentration in the water by the amount of current passed through the electrolytic cell to produce ozonated water having a specified concentration of dissolved ozone; separating gaseous ozone from the stream of ozonated water delivered to the ultrasonic scaler handpiece using the two or more gas separators; delivering the ozonated water to the ultrasonic scaler handpiece; Corresponding to the installation of the two or more recirculation loops, switching the electric polarity of the electrolytic cell after a specified operating time and after confirming that the ozone gas in the water has decayed, so that the side of the aqueous ozone solution ultrasonic scaler system that was the cathode side in a previous operation becomes the anode side in a current operation, and the other side of the aqueous ozone solution ultrasonic scaler system that was the anode side in a previous operation becomes the cathode side in a current operation, so as to distribute membrane deterioration resulting from the interaction of ozone gas with other oxidizing species from the electrolytic cell across both sides of the electrolytic cell to extend the life of the membrane of the electrolytic cell; Including, a processor of a device for supplying ozonated water to the ultrasonic scaler handpiece or a computer system for supplying ozonated water to the ultrasonic scaler handpiece performs all of the steps above; method.

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

3. 10. The method of claim 1, wherein the switching step eliminates or substantially eliminates stagnant water and microbial contamination.

4. 10. The method of claim 1, wherein the water delivered from the water supply is deionized water or water obtained from reverse osmosis.

5. 10. The method of claim 1, further comprising slowing down a flow of the ozonated water entering the two or more gas separators using an inlet baffle to substantially reduce backflow within a chamber of the two or more gas separators and to prevent air bubbles from being carried to an outlet port of the two or more gas separators.

6. 1. An apparatus for supplying ozonated water to an ultrasonic scaler handpiece, comprising: a water supply for delivering water to an electrolytic cell of an aqueous ozone ultrasonic scaler, the electrolytic cell being connected to the water supply through a fluid path and adapted to receive an electrical current for generating ozone gas in the water to produce ozonated water; two or more gas separators, each disposed in a corresponding recirculation loop of the fluid pathway that also contains the electrolytic cell, each gas separator configured to separate gaseous ozone from a stream of ozonated water delivered to the ultrasonic scaler handpiece; one or more ultraviolet sensors disposed in the recirculation loop of the fluid path adapted to measure the concentration of dissolved ozone in the water by the amount of ultraviolet light absorbed by the dissolved ozone in the water passing through a water supply column; Equipped with Corresponding to the installation of two or more recirculation loops, the electrolytic cell is configured to switch the electric polarity after a specified operating time and after confirming that the ozone gas in the water has decayed, so that a side of the ozone aqueous solution ultrasonic scaler that was a cathode in a previous operation becomes an anode in a current operation, and another side of the ozone aqueous solution ultrasonic scaler that was an anode in a previous operation becomes a cathode in a current operation, so as to distribute membrane deterioration resulting from the interaction of ozone gas with other oxidizing species from the electrolytic cell across both sides of the electrolytic cell to extend the life of the membrane of the electrolytic cell. Device.

7. The apparatus of claim 6 , further comprising one or more pumps disposed in the fluid path to control system pressure in at least a portion of the fluid path.

8. The apparatus of claim 6 , further comprising one or more valves disposed in the fluid path to release gas to control further system pressure in at least a portion of the fluid path.

9. 7. The apparatus of claim 6, further comprising two or more level sensors connected to the two or more gas separators for measuring a level of ozonated water in the gas separator.

10. The apparatus of claim 6, further comprising an ozone destructor disposed within the gas release paths of the two or more gas separators and adapted to convert separated gaseous ozone gas into oxygen.

11. 7. The device of claim 6, wherein the water source is a spout pouch or a water bottle having a duckbill connection assembly for delivering the water in a single direction.

12. The apparatus of claim 6 , wherein the water source is held in a loading tray in a base of the apparatus.

13. 7. The apparatus of claim 6, wherein the polarity of the electrolyzer is switchable to reverse the side of the apparatus which produces the ozone gas.

14. 7. The apparatus of claim 6, further comprising a light emitting diode (LED) source and a detector photodiode disposed across each of the one or more ultraviolet sensors, the LED source configured to project ultraviolet light toward the detector photodiode to measure an amount of ultraviolet light absorbed by dissolved ozone, and a monitor photodiode disposed proximate the LED source configured to measure changes in output intensity of the LED source to compensate for degradation of the LED source over time.

15. 12. The device of claim 11, wherein the spout pouch or water bottle has a radio frequency identification (RFID) label configured to be read to prevent reuse or use of an alternative water source that does not have an RFID label.

16. 1. A computer system for supplying ozonated water to an ultrasonic scaler handpiece, comprising: delivering water from a water supply to an electrolytic cell of the aqueous ozone ultrasonic scaler system; applying an electric current to the electrolytic cell to generate ozone gas in the water; providing two or more recirculation loops in a fluid path for moving the water and ozone gas through the electrolytic cell and two or more gas separators corresponding to each of the two or more recirculation loops; controlling the level of ozone gas concentration in the water by the amount of current passed through the electrolytic cell to produce ozonated water having a specified concentration of dissolved ozone; separating gaseous ozone from the stream of ozonated water delivered to the ultrasonic scaler handpiece using the two or more gas separators; delivering the ozonated water to the ultrasonic scaler handpiece; Corresponding to the installation of two or more recirculation loops, switching the electric polarity of the electrolytic cell after a specified operating time and after confirming that the ozone gas in the water has decayed, so that the side of the aqueous ozone scaler system that was the cathode side in a previous operation becomes the anode side in a current operation, and the other side of the aqueous ozone scaler system that was the anode side in a previous operation becomes the cathode side in a current operation, so as to distribute the membrane deterioration resulting from the interaction of the ozone gas with other oxidizing species from the electrolytic cell across both sides of the electrolytic cell to extend the life of the membrane of the electrolytic cell; 1. A computer system comprising: a processor configured to execute

17. 17. The computer system of claim 16, wherein the processor is further configured to execute the step of using one or more pumps to maintain a prescribed fluid level and pressure in the aqueous ozone ultrasonic scaler system to increase the solubility of the ozone gas in the water.

18. 20. The computer system of claim 16, wherein the switching step eliminates or substantially eliminates stagnant water and microbial contamination.

19. 17. The computer system of claim 16, wherein the water delivered from the water supply is deionized water or water obtained from reverse osmosis.

20. When executed by a computer system, the computer system delivering water from a water supply to an electrolytic cell of the aqueous ozone ultrasonic scaler system; applying an electric current to the electrolytic cell to generate ozone gas in the water; providing two or more recirculation loops in a fluid path for moving the water and ozone gas through the electrolytic cell and two or more gas separators corresponding to each of the two or more recirculation loops; controlling the level of ozone gas concentration in the water by the amount of current passed through the electrolytic cell to produce ozonated water having a specified concentration of dissolved ozone; using the two or more gas separators to separate gaseous ozone from the stream of ozonated water delivered to an ultrasonic scaler handpiece; delivering the ozonated water to the ultrasonic scaler handpiece; Corresponding to the installation of two or more recirculation loops, switching the electric polarity of the electrolytic cell after a specified operating time and after confirming that the ozone gas in the water has decayed, so that the side of the aqueous ozone scaler system that was the cathode side in a previous operation becomes the anode side in a current operation, and the other side of the aqueous ozone scaler system that was the anode side in a previous operation becomes the cathode side in a current operation, so as to distribute the membrane deterioration resulting from the interaction of the ozone gas with other oxidizing species from the electrolytic cell across both sides of the electrolytic cell to extend the life of the membrane of the electrolytic cell; A non-transitory computer-readable storage medium storing a program for causing a computer to execute a procedure including the steps of:

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