Irrigation solutions that reduce or eliminate aerosol generation during dental and surgical procedures

Abstract

Compositions are described for reducing / eliminating aerosolization in dental / surgical cleaning procedures. One or more compositions can be provided in substantially similar concentrations to reduce / eliminate aerosolization.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 030,340, filed May 27, 2020, the entire contents of which are incorporated by reference. [Background technology]

[0002] Dental or surgical procedures involving rotary, laser, kinetic, and ultrasonic instruments utilize irrigation water that is aerosolized during the procedure. -4 Microparticles (diameters ~10 μm) are known to carry respiratory viruses (e.g., SARS, SARS-CoV-2). Aerosols and droplets generated during these procedures can travel great distances. Due to the current global pandemic and the possibility that viruses or microorganisms may be transmitted by similar vectors in the future, the risk of disease transmission during these dental / surgical procedures has received increased attention. Aerosolization can occur during certain dental / surgical procedures, particularly from the use of water during the procedure. Because aerosolized droplets may carry viruses and other microorganisms, infection control efforts can require significant time and expense. Therefore, strategies are needed to safely perform dental and other surgical procedures, especially those involving patients carrying infectious microorganisms such as SARS-CoV-2.

[0003] Additionally, droplets and aerosols generated during the handling of dental rotary, kinetic, and ultrasonic instruments can reduce the operator's visibility of the work area, especially when using magnifying glasses. The droplets and aerosols can fog eyeglasses, goggles, and face shields and contaminate the patient's body, clothing, and nearby work surfaces. Summary of the Invention

[0004] The present disclosure provides compositions and systems suitable for cleaning during dental or surgical procedures where the treatment area is frequently cleaned with an aqueous composition. Additionally, methods for using the compositions are provided. The compositions, systems, and methods are particularly useful when there is a potential risk of microbial infection, such as viral or bacterial infection.

[0005] The compositions of the present disclosure are aqueous compositions that include or consist essentially of one or more polymers. The polymers may be natural or synthetic. Data is provided to demonstrate that the use of aqueous compositions containing polymers reduces aerosolization.

[0006] In one embodiment, the present disclosure provides a system for cleaning a treatment area. For example, the system includes a water line for use with a dental unit configured to deliver a composition including one or more polymers or an aqueous composition consisting essentially of one or more polymers. The composition is released into the dental treatment area under pressures typically used in dental procedures. In various embodiments, the system includes a dental unit water bottle (also referred to herein as a reservoir) containing the aqueous composition including the polymers and a water line that delivers the composition to the dental treatment area. The system may further include a control, such as a dental handpiece, for controlling the flow or release of the composition into the dental treatment area.

[0007] The compositions and systems can be used in surgical / dental procedures to cleanse treatment areas. For example, the compositions can be used when aerosols can be generated by water irrigation using rotational, ultrasonic, or dynamic agitation. Reducing or eliminating aerosols at the point of generation prevents airborne / aerosol transmission of viruses. Currently, amid the COVID-19 pandemic, elective surgical or dental procedures are frequently postponed. Alternatively, unusual and extensive protective measures, requiring permanent or mobile installations in the operating room, are being used, increasing the cost and time required for surgical or dental procedures. The disclosed methods, compositions, and systems can reduce the risk of aerosol disease transmission to patients, healthcare workers, and bystanders, and normalize dental treatment. Furthermore, reducing aerosols in dental procedures improves operator visibility, allowing for more accurate and timely treatment. Reducing aerosol and droplet formation also benefits patients by preventing contamination of exposed body parts and clothing with airborne residues from dental procedures. [Brief explanation of the drawings]

[0008] For a more complete understanding of the content and objects of the present disclosure, the following detailed description, taken in conjunction with the enclosed figures, is provided.

[0009] FIG. 1 shows a schematic diagram of the setup for testing compositions for aerosol reduction effectiveness.

[0010] Figure 2 shows images of aerosol formation in the presence of a given material / composition. The image on the left is in the presence of water, where the entire substance is aerosolized. The image on the right is in the presence of a very dilute PEO solution, where only large droplets are formed and no fine aerosol is formed.

[0011] Figure 3 shows images of aerosol formation in the presence of a given material / composition. By gradually increasing the PEO concentration, aerosol formation was completely suppressed. The left image shows substantial suppression, and the right image shows complete suppression.

[0012] Figure 4 shows the experimental setup used to measure the distance traveled by the aerosol and droplets formed at the tip of a dental scaler during ultrasonic agitation. The left image shows a glass slide for collecting droplets, the center image shows a series of recorded image frames of aerosol formation when water was used as the cleaning material, and the right image shows a schematic diagram of the key elements of the experimental setup.

[0013] Figure 5 shows the cleaning efficiency of a zirconia block model varnished with dyed Fluorprotector S (the top of the zirconia was not cleaned) compared with water and a 0.1% PEG 600kDa solution.

[0014] FIG. 6 shows one embodiment of the system of the present disclosure, which includes a separate reservoir.

[0015] FIG. 7 shows another embodiment of the system of the present disclosure configured in line with a dental unit water line.

[0016] FIG. 8 illustrates yet another embodiment of the system of the present disclosure, configured to be connected to supply an aqueous composition to a dental unit water line. DETAILED DESCRIPTION OF THE INVENTION

[0017] Features of the claimed invention are described in the specification as specific embodiments and examples. However, other embodiments and examples that do not have all of the advantages and features of the embodiments and examples described in the specification are also within the scope of the disclosure. Various structural, logical, and process steps may be included without departing from the scope of the disclosure.

[0018] All numerical ranges specified herein are inclusive of the limits, and also include all narrower ranges subsumed therein, as if they were expressly written herein, and unless otherwise expressly stated, all values include up to one-tenth of the lower limit.

[0019] As described herein, the present disclosure provides a system for irrigating a treatment area. The system delivers a suitable composition, i.e., an aqueous solution and its mixture (synthetic polymer) at an appropriate concentration as provided herein, that can reduce or eliminate the number of aerosolized droplets generated during dental / surgical irrigation procedures. The system improves the safety of dental / surgical irrigation processes. The reduction or elimination of aerosols can reduce or prevent airborne or aerosolized transmission of viruses. Without being bound by theory, it is believed that increasing the extensional viscosity of dental / surgical irrigation solutions contributes to the reduction or elimination of aerosolized droplets during dental / surgical irrigation procedures. More specifically, aerosolization can be measured or eliminated by manipulating the extensional viscosity of the irrigation medium (i.e., its ability to undergo extensional stresses during droplet formation from the liquid) by adding a polymeric material (i.e., a polymer).

[0020] Dentistry involves routine patient treatments every day using rotary, ultrasonic, kinetic, and laser-based instruments. All of these instruments use water irrigation or water / air syringes to cool tooth surfaces and / or clean deposits from teeth. When providing water irrigation, high pressure differentials or high speeds of moving parts continuously generate numerous aerosol droplets. These aerosols can spread many feet beyond the patient's mouth and the area where the dentist is working. Multiple viruses, including the SARS-CoV-2 virus, are spreading throughout the United States and around the world. Several studies have demonstrated that the SARS-CoV-2 virus spreads both via droplets (visible droplets) and aerosol transmission. In dentistry, aerosol generation is an unavoidable part of most dental / surgical cosmetic and cleaning procedures, creating a high-risk situation with the potential to spread the virus to others over long distances.

[0021] The U.S. Centers for Disease Control and Prevention (CDC) and the Occupational Safety and Health Administration (OSHA) consider dental procedures to be the "highest risk" for the potential spread of SARS-CoV-2 and other respiratory viruses. Several approaches exist to reduce or eliminate the virus: (1) canceling or postponing dental treatment (public and individual health risks); (2) screening patients immediately prior to dental treatment (although adequate testing is not yet available); and (3) using engineering controls in conjunction with strict PPE to block or remove aerosolized virus. As described herein, altering the physical response of water to rotational or ultrasonic forces used in dentistry can reduce or completely eliminate the generation of aerosol droplets and the distance aerosols can spread beyond their point of generation.

[0022] The advantages of the composition herein compared to other management and engineering methods can be listed as follows: (1) Direct mitigation of aerosol formation. (2) Significant and complete aerosol removal that does not depend on human action except as included in the procedure. (3) Low cost compared to engineering controls including airflow (HVAC) or room construction. (4) The simplicity of substituting the cleaning solution for water otherwise used. (5) No additional hardware is required that requires sterilization between patients. (6) Can be easily stored at room temperature. (7) broad applicability to most, if not all, clinical settings, including those with inadequate access to care community support; (8) Low-tech = no training required. (9) Scalable to small to large organizations. (10) Flavor / color available (11) No ongoing human involvement is required.

[0023] In various embodiments, this water-based irrigation solution is a two-part solution containing, at a minimum, water and a defined concentration or concentration range of a biocompatible, high-molecular-weight polymer or other rheologically similar compound. A further extension of the principles described herein is the reduction of aerosols in surgical irrigation solutions (typically 0.9% saline) to achieve the same reduction in aerosols in other surgical fields using water-based irrigation (e.g., orthopedic surgery or wound debridement). This irrigation solution is used in a standard dental chair connected to the water system. The irrigation solution reduces or completely eliminates aerosol generation. It is not antiviral / antibacterial, nor is it intended to kill viruses / bacteria. Therefore, in clinical dentistry, PPE must be used to protect against natural aerosolization (speaking, coughing, sneezing) by workers.

[0024] Many embodiments can be constructed in accordance with the principles herein, and several exemplary embodiments are provided to showcase these features (see FIG. 1) and to showcase other examples cited herein that achieve results in accordance with the principles herein.

[0025] In one aspect, the present disclosure provides aerosolization-reducing compositions for use in medical, dental, or surgical procedures (see Figures 2 and 3). The compositions consist essentially of a polymer and water, or consist of a polymer and water. In various embodiments, the compositions are free of organic solvents. In various embodiments, the compositions are not in the form of personal care or cleaning products. In various embodiments, the only component in the composition other than water is the polymer. In various embodiments, the compositions further comprise one or more non-functional additives or excipients. Non-functional additives or excipients do not affect (e.g., do not substantially affect) the shear viscosity and / or extensional viscosity of the composition, but provide a secondary effect, such as imparting flavor to the composition.

[0026] The composition reduces or eliminates the formation of aerosol droplets. As used herein, "reducing aerosol droplet formation" or similar terms refers to reducing the number of aerosol droplets generated during rinsing and / or mechanical agitation of a liquid (e.g., water) (e.g., during rinsing teeth with water in a dental procedure). For example, the number of droplets generated during a dental cleaning procedure can be reduced. Reduced aerosolization can result in reduced droplet formation, including complete suppression (e.g., elimination) of aerosol formation, as shown in Figures 2 and 3. In one embodiment, droplets with a size (diameter) of 5 μm to 100 μm, 5 μm to 75 μm, 5 μm to 50 μm, 5 μm to 25 μm, or 5 μm to 10 μm are eliminated or the formation of droplets of these sizes is reduced. The aerosol droplets include the composition, water, and / or saliva. In various other examples, the aerosol droplets are not formed by additional cleaning agents, such as, for example, personal cleaning products, toothpaste, etc., or combinations thereof.

[0027] Various polymers or combinations thereof may be used in the compositions of the present disclosure, including but not limited to polyethylene oxide, xanthan gum, polyvinylpyrrolidone, alginic acid, hyaluronic acid, chondroitin sulfite, and the like, and combinations thereof.

[0028] The aqueous polymer comprising the composition of the present disclosure has a favorable combination of viscoelastic parameters.For example, favorable viscoelasticity refers to a low shear viscosity (about the viscosity of water) compared to a high extensional viscosity, that is, the ability of the liquid medium to flow under low stress (for example, when passing through a liquid supply tube) without experiencing extensional stress (the generation of droplets or aerosols under the presence of rapidly rotating or vibrating surfaces or pressures).In one embodiment, the shear viscosity is low and the extensional viscosity is high. For example, shear viscosity is 0.001-1000 poise, including increments of 0.001 poise and ranges thereof (e.g., 0.001-500, 0.001-250, 0.001-100, 0.001-50, 0.001-25, 0.001-10, 0.001-1, 0.001-0.1, 0.001-0.01, 0.01-500, 0.01-250, 0.01-100, 0.01-50, 0.01- 25, 0.01-10, 0.01-1, 0.01-0.1, 0.1-500, 0.1-250, 0.1-100, 0.1-50, 0.1-25, 0.1-10, 0.1-1, 1-1000, 1-500, 1-250, 1-100, 1-50, 1-25, 1-10, 10-1000, 10-500, 10-250, 10-100, 10-50, 10-25, 100-1000, or 100-500 poise). For example, the extensional viscosity is 100-10 7 poise, including all integers and ranges thereof. In some embodiments, the extensional viscosity should be at least one order of magnitude higher than the shear viscosity. For example, the extensional viscosity may be 10, 100, 1000, or 10,000 times or more the shear viscosity of the aqueous composition. In yet other embodiments, the shear viscosity of the composition is less than 6 mPas.

[0029] Viscosity can be measured by various methods known in the art. For example, intrinsic viscosity can be measured using an Ubbelohde viscometer and / or a Jimmie-Crothers viscometer. For example, compositions of polymers at different concentrations can be measured using an Ubbelohde viscometer. The flow time of a fixed amount of the composition at various concentrations is measured. The intrinsic viscosity is obtained after extrapolation of the two plots of reduced viscosity and logarithmic viscosity at zero concentration. Reduced viscosity: η red =η sp / C vs C Logarithmic viscosity: η inh =ln(η rel ) / C vs C where C is g / cm 3 The reduced viscosity can be calculated by the following formula: η red =η sp / C=(η rel -1) / C η rel =η / η0=t / t0. In this equation, "η0" is the dynamic viscosity of the solvent, "t" is the flow time of the polymer solution, and "t0" is the flow time of the solvent at the temperature being measured. The same procedure can be used with a Jim Crothers viscometer.

[0030] Shear viscosity can be measured by various methods known in the art. For example, shear viscosity can be measured by a rheometer. Rheometers are available in various geometries, such as a cone-and-plate geometry, and rotational viscometers (e.g., Couette rotational viscometers) can be used. Shear viscosity can be measured at various concentrations of polymer.

[0031] Extensional viscosity can be measured by various methods known in the art. For example, extensional viscosity can be measured using an extensional rheometer, which is based on the self-thinning of a liquid thread of a sample under the action of surface tension. This device requires only a single drop of liquid to measure the rheological behavior. Typically, the device has two plates, an upper plate and a lower plate, between which a drop of sample is placed. A magnetic coil is used to fix the position of the upper plate, thereby forming a liquid thread of the sample. The decrease in thread radius (α) over time (t) is expressed by the following equation: α=α0e -t / 3θ where α0 is the initial yarn radius at t = 0 and θ is the relaxation time. The extensional viscosity (μel) is given by: μ el =(3θσ / 2α0)e t / 3θ where σ is the surface tension constant. Determining the extensional viscosity also determines the annual elastic relaxation time.

[0032] The polymer may be a natural polymer and / or a synthetic polymer. Examples of synthetic polymers include polyethylene oxide (also known as PEO or polyethylene glycol (PEG)) and polyvinylpyrrolidone (PVP). Examples of natural polymers include, but are not limited to, alginic acid, xanthan gum, hyaluronic acid, chondroitin sulfite, and the like, and combinations thereof. Additional examples include surfactants and micelles formed from surfactants.

[0033] Polymers have a variety of molecular weights (Mw and / or Mn). For example, polymers have molecular weights (Mw or Mn) from 1 kDa to 10 MDa, including 1 Da increments and ranges therebetween. For example, polyethylene oxide has a molecular weight from 1 kDa to 10 MDa, including 1 Da increments therebetween. Polyethylene oxide may have a molecular weight of 600 kDa or 8 MDa. Polyacrylic acid (PAA) may have a molecular weight of 450 kDa. Xanthan gum may have a molecular weight of 1-7 MDa. Alginic acid may have a molecular weight of 10-600 kDa. The polymer may be a linear polymer. In some embodiments, the polymer may be a branched polymer.

[0034] In some embodiments, a combination of the same polymers with different molecular weights is used (e.g., a composition comprising 600 kDa polyethylene oxide and 8 MDa polyethylene oxide, each at different concentrations). In various examples, a combination of different polymers with the same or similar molecular weights (Mw and / or Mn, where Mw is the weight average molecular weight and Mn is the number average molecular weight) or a combination of different polymers with different molecular weights (Mw and / or Mn) is used. The molecular weight of a polymer is measured by methods known in the art, such as by comparison with standard polystyrene.

[0035] The polymer has a dispersity within a certain range. For example, the dispersity (D) (expressed as Mw / Mn) is 1.00 to 6.00, including increments of 0.01 therebetween and ranges therebetween. In various examples, the dispersity is 1 or greater. In various embodiments, the polymer is monodisperse or polydisperse. Methods for measuring molecular weight and dispersity are known in the art. For example, the dispersity of a polymer can be measured by comparison with standard polystyrene or by light scattering.

[0036] In embodiments, the polymer can be in a concentration suitable for use in a dental unit waterline. For example, the final concentration of the polymer when contacting the dental treatment area can be 0.01 wt% (100 ppm) to 5 wt% (50,000 ppm), including all integer ppm values and ranges therebetween. For example, the concentration can be 0.01-1 wt%, 0.01-2 wt%, 0.01-3 wt%, 0.01-4 wt%, 0.05-1 wt%, 0.05-2 wt%, 0.05-3 wt%, 0.51-4 wt%, 0.1-1 wt%, 0.1-2 wt%, 0.1-3 wt%, 0.1-4 wt%, 1-2 wt%, 1-3 wt%, or 1-4 wt%.

[0037] In various examples, the composition may comprise polyethylene oxide having a molecular weight of 600 kDa and a concentration of 0.1 wt% (1000 ppm); polyethylene oxide having a molecular weight of 600 kDa and a concentration of 1 wt% (10,000 ppm); polyethylene oxide having a molecular weight of 2 MDa and a concentration of 0.01 wt% (100 ppm); polyethylene oxide having a molecular weight of 2 MDa and a concentration of 0.05 wt% (500 ppm); polyethylene oxide having a molecular weight of 2 MDa and a concentration of 0.1 wt% (1000 ppm); polyethylene oxide having a molecular weight of 2 MDa and a concentration of 1 wt%; polyethylene oxide having a molecular weight of 8 MDa and a concentration of 0.01 wt% (100 ppm); Polyethylene oxide in an amount of 8 MDa and a concentration of 0.05% (500 ppm); polyethylene oxide in an amount of 8 MDa and a concentration of 1 wt% (10,000 ppm); polyethylene oxide in an amount of 8 MDa and a concentration of 1 wt% (10,000 ppm); polyethylene oxide in an amount of 8 MDa and a concentration of 1 wt% (10,000 ppm); xanthan gum in a concentration of 0.1 wt% (1,000 ppm); xanthan gum in a concentration of 0.5 wt% (5,000 ppm); xanthan gum in a concentration of 1 wt% (10,000 ppm); pyrrolidone in a concentration of 1 wt% (10,000 ppm); pyrrolidone in a concentration of 5 wt% (50,000 ppm); or alginic acid (alginic acid polysaccharide) in a concentration of 2 wt% (20,000 ppm).

[0038] The polymer may be charged or substantially uncharged. The polymer may be cationic, anionic, or zwitterionic.

[0039] The polymers preferred for the compositions of the present disclosure have favorable solubility in aqueous media (e.g., aqueous mixtures containing water or other liquids, such as ethylene glycol) and are soluble up to the boiling point of the solvent. The solubility of the polymer may change with increasing ambient temperature. The solubility of the agent is 0.001 wt% to 25 wt%. When added to an aqueous medium, the polymer forms a composition with low shear viscosity and high extensional viscosity. The solubility of the polymer should be such that it is easily miscible with water.

[0040] The composition may contain various additives that do not substantially change the viscoelastic properties, including, but not limited to, hydrogen peroxide, antioxidants or antioxidant synergists, chelating agents, flavors, colorants, antibacterial agents, preservatives, biofilm removers, particles, tartar or plaque staining dyes, wetting agents / detergents, and combinations thereof.

[0041] In various embodiments, the composition further comprises one or more stabilizers. Non-limiting examples of stabilizers include those in the table below.

[0042] Table 1: Non-limiting list of stabilizers [Table 1]

[0043] The advantage of the composition of the present disclosure is that, during dental treatment, its components (e.g., PEO, etc.) are quickly washed away and do not remain in the treatment area, so they do not affect subsequent steps. The absence of adverse effects (e.g., adhesion of adhesives, etc.) caused by the composition of the present disclosure is extremely important for subsequent dental treatments.

[0044] In one aspect, the present disclosure provides a dental unit system that reduces aerosol particle generation (e.g., compared to water alone) when discharging a composition into a dental treatment area during a dental procedure. The dental unit system includes a dental unit bottle and a water line configured to deliver a composition, including the aqueous polymer composition described herein, to a patient's dental treatment area. The system may optionally include a handpiece to control the release of the composition into the dental treatment area. The system can be configured for use as a pre-formed, ready-to-use aerosolization-reducing composition, or it can be configured to dilute a concentrated aerosolization-reducing composition from a reservoir containing the concentrated composition at any point before use in the treatment area. This can be done for dental instruments with a water reservoir (e.g., a mobile dental scaling unit) by replacing the commonly used water in the reservoir with an embodiment of the disclosed composition. Meanwhile, non-mobile dental instruments (e.g., a fixed ultrasonic scaler) can be integrated into the dental chair and attached to a primary water source (e.g., a dental unit water line). Such instruments may also have a port for continuous introduction of a disinfectant to prevent biofouling of the liquid supply system. This port can be used to deliver the correct amount of concentrate of the disclosed composition to the water line so that it can be diluted to the desired concentration as it passes through the liquid delivery system and reaches the handpiece.

[0045] Some functional composition properties, such as shear viscosity and flow rate within a scaling unit (e.g., the EMS Scaler PIEZON 250), are particularly relevant to the use of the composition. For example, the liquid delivery system incorporated into ultrasonic scalers using built-in liquid reservoirs is designed for use with liquids of water-like viscosity. The rate at which the liquid is delivered to the scaler tip or other relevant components cannot be significantly altered without affecting the device's functionality or requiring modification of the liquid delivery system. Beneficially, the compositions of the present disclosure can be used with tools without modifying the tool, allowing for quick and easy implementation.

[0046] In one aspect, the present disclosure is embodied as a system for reducing aerosolization within a dental instrument (e.g., a water syringe, an air / water syringe, an ultrasonic scaler, etc.). The system includes a reservoir containing one or more polymers selected from polyethylene oxide, xanthan gum, polyvinylpyrrolidone, alginic acid, hyaluronic acid, chondroitin sulfite, and combinations thereof. A supply line is in fluid communication with the reservoir. The supply line is configured to supply the one or more polymers from the reservoir to a dental dispenser as a final concentration of an aqueous composition (i.e., the aqueous composition delivered to the instrument). In some embodiments, the final concentration is 0.01 to 5 wt% of the total concentration of the one or more polymers, based on the total weight of the aqueous composition. System embodiments are configured for any final concentration of the compositions disclosed herein.

[0047] As shown in FIG. 6, a system 10 for supplying an aqueous composition to a dental appliance 90 includes a reservoir 12. The reservoir 12 contains one or more polymers according to any of the embodiments described herein. A supply line 14 is in fluid communication with the reservoir. In the system 10 disclosed in FIG. 6, the reservoir is a stand-alone (i.e., independent) reservoir. Therefore, the one or more polymers contained in the reservoir are already part of the aqueous composition at a final concentration. This allows the supply line 14 to deliver the aqueous composition to the dental appliance 90 at the final concentration (the same concentration as in the reservoir).

[0048] 7, system 40 may be configured to be attached to (i.e., retrofitted into) an existing dental unit. For example, reservoir 42 may be configured to be secured in-line with the dental unit such that the inlet of reservoir 42 is connected in series with dental unit water line 95. In this case, water flow from the dental unit water line enters the reservoir and mixes with one or more polymers contained therein. The one or more polymers contained within the reservoir may be concentrated (e.g., in concentrated liquid form, solid form) to provide a desired final concentration for the aqueous composition emerging from reservoir 42 via supply line 44.

[0049] 8, system 80 is configured to be attached to a dental unit water line 95. In such an embodiment, supply line 84 fluidly secures reservoir 82 to water line 95 so that material contained in the reservoir can be introduced into the water line.

[0050] In some embodiments, the system 80 further includes a flow sensor 86 that measures the flow of water in the dental unit water line. The system 80 further includes an actuator 88 that varies the flow of the aqueous composition from the reservoir 82 based on the measured water flow (e.g., as measured by the flow sensor 86). For example, the actuator may be a variable valve that controls the flow of the composition from the reservoir. As another example, the actuator may be a variable speed pump that can dispense the composition from the reservoir at a desired rate based on the measured water flow in the water line. The actuator may passively control the flow of the composition, such as with an orifice sized to control the flow at a predetermined rate. In some embodiments, the actuator may directly control the composition, such as with an electronically or mechanically controlled valve that varies the flow of the composition based on a measurement of the flow of liquid (e.g., water) through the supply line. In this case, the actuator is configured to control the flow of the storage agent in the reservoir so that the resulting aqueous composition has properties consistent with those disclosed herein. For example, the actuator may be configured so that the final concentration of polymer (in water) upon reaching the dental treatment area is 0.01 wt% (100 ppm) to 5 wt% (50,000 ppm) based on the total weight of the solution, including all integer values and ranges of ppm therebetween. For example, concentrations may be 0.01-1 wt%, 0.01-2 wt%, 0.01-3 wt%, 0.01-4 wt%, 0.05-1 wt%, 0.05-2 wt%, 0.05-3 wt%, 0.51-4 wt%, 0.1-1 wt%, 0.1-2 wt%, 0.1-3 wt%, 0.1-4 wt%, 1-2 wt%, 1-3 wt%, or 1-4 wt%. Such final concentrations may depend on the delivery fluid flow (e.g., fixed or variable), the composition flow (fixed or variable accordingly), the concentration of the polymer, etc.

[0051] In some embodiments, the polymer may be added to a supply line through which a fluid is flowing. For example, the composition may be forced into the fluid using the Venturi effect. In other embodiments, a reservoir may be pressurized to inject the composition into the supply line (e.g., automatically or selectively). In such embodiments, the composition may be delivered as a fluid to the supply line.

[0052] In some embodiments, the polymer is a solid (e.g., granules or other form). In such embodiments, the fluid flow (or a portion of the flow) from the supply line may be directed to a reservoir to mix / dissolve with the polymer for subsequent (downstream) administration to the patient. Such embodiments may also be used with fluid (liquid) polymers.

[0053] In some embodiments, a combination of techniques may be used, for example, in some embodiments, a portion of the flow from the feed line may be redirected to a reservoir to dissolve and / or dilute the polymer, and then rejoined with the remainder of the flow in the feed line.

[0054] In one aspect, the present disclosure provides a method for reducing or eliminating the formation of aerosol droplets during surgical irrigation and dental procedures. The method includes preparing an aqueous irrigation composition of the present disclosure containing a polymer and introducing the composition into a surgical area, such as a dental treatment area, at atmospheric or pressurized pressure. Aerosolization in this method is reduced compared to aerosolization occurring when using an aqueous composition that does not contain a polymer.

[0055] In various examples, the method reduces or eliminates aerosol droplets formed during cleaning procedures (e.g., dental procedures). In various examples, the method includes irrigating a patient's oral cavity with an aqueous composition containing a polymer. The aerosolization generated by or during the dental procedure is less than that generated by an aqueous medium without a polymer. In one embodiment, the composition is a low-aerosolization cleaning composition. The cleaning composition is preferred for use in cleaning biological cavities / surfaces or with dental or surgical instruments. The disclosed compositions and methods are preferably used with ultrasonic, rotary, or kinetic agitators used in treatment areas, such as dental treatment areas. The disclosed compositions and methods are used to reduce aerosolization during cleaning (e.g., sterilization) of surgical or other instruments or surfaces associated with a clinical setting, such as, for example, using an ultrasonic bath containing the composition as the bath.

[0056] The compositions of the present disclosure may be provided ready to use or as a liquid concentrate or powder that can be reconstituted into a ready-to-use composition at any time before or at the time of use.

[0057] In various examples, the composition may be provided to the dentist or dental hygienist in various forms (e.g., concentrated or final diluted). Examples include polyethylene oxide concentrates (similar to previously used liquid-supply disinfectant concentrates) for dilution prior to use in a scaler unit with a liquid reservoir, where the final concentration of polyethylene oxide can be directly loaded into the scaler's liquid reservoir, or for automatic dilution in the dental chair unit's supply unit. Optionally, a preservative may be added to the container to protect against microbial contamination (e.g., a standard FDA-approved preservative). For example, a concentrated composition may have a concentration 5-100 times more concentrated than 0.01 wt% (100 ppm) to 5 wt% (50,000 ppm). In embodiments, the concentrated composition may be concentrated 5-10x, 5-25x, 5-50x, 5-75x, 10-20x, 10-50x, 10-75x, 10-100x, 25-50x, 25-75x, 25-100x, 50-75x, 50-100x, or 75-100x. The concentrate compositions are: 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, It may be 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, or 100 times concentrated. For example, a concentrated composition may have a concentration of 500 ppm to 99,000 ppm, including all ppm integer values and ranges therebetween. In examples, concentrated compositions have a concentration of 500 to 1,000, 500 to 10,000, 500 to 100,000, 500 to 990,000, 1,000 to 10,000, 1,000 to 100,000, 1,000 to 990,000, 10,000 to 100,000, 10,000 to 990,000 or 100,000 to 990,000 ppm.

[0058] The composition can be used in various treatment processes where cleaning liquids are used. For example, the composition and method may be performed on individuals undergoing surgical or dental procedures. Examples of dental procedures include, but are not limited to, ultrasonic, rotary dynamic cleaning, particle abrasive polishing, cavity preparation, fissure extension, root canal preparation, occlusion adjustment during restorative work, implants, medical procedures (e.g., ultrasonic debridement of wounds, water-cooled bone drilling, irrigation, etc.), and procedures requiring air or water spray cleaning. The composition of the present disclosure can be incorporated into existing cleaning equipment and water lines, such as those found in dental examination / treatment rooms. In various examples, the composition may be used in an ultrasonic bath. In various other examples, the composition may be used as a coolant.

[0059] Any of the above-described embodiments for use in human medicine are equally applicable to veterinary uses, for example, any of the above embodiments may be applied to any surgical procedure used in veterinary care that generates an aerosol.

[0060] In one aspect, the present disclosure provides kits that may include components of the disclosed compositions or may include the disclosed compositions dispensed in ready-to-use containers for a surgical or dental procedure.

[0061] The kit may include separate containers for the polymer and a suitable aqueous medium, such as water, to prepare a composition for use in rinsing the treatment area. The containers containing the water or polymer may contain additives, or the additives may be provided separately. For example, the kit may include the polymer, sterile water, and optional additives. The polymer may be provided in any form, such as a concentrated liquid or powder. The kit may further include disposable items, such as hoses, fittings, and other items used to deliver the compositions of the present disclosure. The kit may further include instructions for preparing and / or using the composition. The kit may include one or more items for connecting a container (e.g., a container containing the composition or another container) to a cleaning system. The kit may include a combination of various disposable items.

[0062] Many embodiments can be constructed in accordance with the principles herein. The following illustrative examples are provided to demonstrate the content of these features and to demonstrate that other examples listed below achieve results in accordance with the principles herein. [Example]

[0063] This example provides an illustration of various compositions of the present disclosure.

[0064] Solutions of various polymers at various concentrations and molecular weights were tested using a representative scaling unit (Piexon 250, EMS (CH)). For testing purposes, the formulations were filled into the liquid reservoir of the scaling unit and aerosol formation during operation of the scaler was evaluated using the test setup described below.

[0065] The following compositions were tested for their ability to thicken and reduce aerosolization of dental / surgical cleaning compositions as used in Piezon 250.

[0066] A decrease in aerosolization was observed at a concentration of 0.1 wt% (1000 ppm) of polyethylene oxide with a molecular weight of 600 kDa, but it was not possible to completely suppress aerosolization.

[0067] 1% by weight (10,000 ppm) of polyethylene oxide with a molecular weight of 600 kDa received a rating of "1" as shown in Table 2 below.

[0068] At a concentration of 0.01 wt% (100 ppm) of polyethylene oxide with a molecular weight of 2 MDa, a reduction in aerosolization was observed, but aerosolization could not be completely suppressed.

[0069] A concentration of 0.05 wt% (500 ppm) of polyethylene oxide with a molecular weight of 2 MDa almost completely suppressed aerosolization.

[0070] A concentration of 0.1 wt % (1000 ppm) of polyethylene oxide with a molecular weight of 2 MDa completely suppressed aerosolization.

[0071] A concentration of 1 wt % (10,000 ppm) of polyethylene oxide with a molecular weight of 2 MDa completely suppressed aerosolization.

[0072] At a concentration of 0.01 wt% (100 ppm) of polyethylene oxide with a molecular weight of 8 MDa, a reduction in aerosolization was observed, but aerosolization could not be completely suppressed.

[0073] A concentration of 0.05 wt% (500 ppm) of polyethylene oxide with a molecular weight of 8 MDa completely suppressed aerosolization.

[0074] A concentration of 0.1 wt% (1000 ppm) of polyethylene oxide with a molecular weight of 8 MDa completely suppressed aerosolization.

[0075] A concentration of 1% by weight (10,000 ppm) of polyethylene oxide with a molecular weight of 8 MDA completely suppressed aerosolization.

[0076] A concentration of 0.1% by weight (1000 ppm) of xanthan gum almost completely inhibited aerosolization (as in some artificial saliva solutions).

[0077] A concentration of 0.5% by weight (5000 ppm) of xanthan gum completely prevented aerosolization (as part of some artificial saliva solutions).

[0078] A concentration of 1% by weight (10,000 ppm) of xanthan gum completely prevented aerosolization (as part of some artificial saliva solutions).

[0079] Polyvinylpyrrolidone concentrations of 1% by weight (10,000 ppm) reduced aerosolization (as part of some artificial saliva formulations).

[0080] A polyvinylpyrrolidone concentration of 5% by weight (50,000 ppm) significantly reduced aerosolization.

[0081] A concentration of 2 wt% (20,000 ppm) of alginic acid (alginic acid, polysaccharide) completely suppressed aerosolization.

[0082] Other compositions having the above polymers, including synthetic polymer compositions for reducing / eliminating aerosolization generation in dental / surgical procedures, can be prepared at appropriate concentrations in substantially the same manner. [Example]

[0083] This example provides an illustration of the quantification of the reduction in aerosolization of compositions of the present disclosure.

[0084] For the purpose of qualitative evaluation of aerosol detection, a glass slide was placed at a predetermined distance from the ultrasonic scaler tip. A false tooth was used to mimic the geometry of the clinical situation. Aerosol droplets generated by the scaler manipulation were collected on the glass slide and qualitatively evaluated with the naked eye. If droplets were not detected, the slide guide was gradually moved closer to the scaler tip until droplets were detected. This distance was determined to be the travel distance of droplets generated by ultrasonic manipulation using the sawmill.

[0085] The flow rate of the scaler was assessed by operating the scaler for a set period of time and collecting the total outflow.

[0086] The test was repeated using a formulation containing trace amounts of fluorescent dye to allow quantitative assessment of the aerosols collected on glass slides by UV / VIS spectroscopy.

[0087] The test setup for the splatter test was as follows (see Figure 4). For the correction test, the boundary condition of whether droplets were present was determined. For the quantitative test, the sodium fluorescein / water / polymer mixture was washed off and analyzed by UV-vis spectrophotometry, and the dye concentration was calculated and used to determine a direct correlation of how much aerosolization / small droplets evolved.

[0088] The following parameters were used to evaluate the effects achieved by the compositions of the present disclosure on a scale of 1 to 4.

[0089] Table 2: Evaluation of the effect of compositions during ultrasonic scaler operation [Table 2]

[0090] Table 3: Qualitative test results [Table 3] TIFF0007723687000004.tif176152n.m.: Not measured

[0091] A variety of industrial polymers, biopolymers, and surfactants were tested. Polyethylene oxide (polyethylene glycol) polymers provided favorable shear viscosity, and therefore favorable flow rate (similar to water), and extensional viscosity, reducing droplet or aerosol formation. Polysaccharides such as hydroxyethyl cellulose or hydroxypropyl cellulose also provided favorable physical properties. However, higher concentrations (1%) and higher shear viscosities resulted in lower flow rates. Hyaluronic acid also performed favorably at 0.1%, but with lower flow rates.

[0092] Table 4: Quantitative testing using splatter and evaluation using fluorescent dye (Na-fluorescein) [Table 4] TIFF0007723687000006.tif234101n.m.: Not measured

[0093] The distance between the scaler and the glass slide was taken as the minimum distance, i.e., the point where droplets were observed on the slide (see Figure 4). A constant was introduced by dividing the logarithmic concentration of fluorescein by the distance from the scaler to the glass slide. Weighted performance was calculated by multiplying this by the specific flow rate of the PIEZON 250 scaler (see Table 4). Additionally, a simulated clinical evaluation was performed in a qualitative manner using a Dentsply Cavitron Scaler. Some experiments were performed with a water supply pressure of 26.5 psi and a flow rate of 40.6 ml / min. (Based on Cavitron manufacturer guidelines, the water supply should be at a minimum of 25 psi (172 kPa) and a maximum of 60 psi (414 kPa).)

[0094] The best performance was observed with polyethylene glycol of 600 kDa molecular weight at concentrations of 1200 to 2400 ppm and polyethylene glycol of 8 MDa molecular weight at a concentration of 280 ppm.

[0095] Needless to say, the reduction in fluid or aerosol formation has a positive effect on the operator's ability to view the surgical field, an effect that is particularly noticeable and helpful when using magnifying loupes, and even more so when using powerful lights to illuminate the surgical field.

[0096] Cleaning Efficacy: To confirm that the introduction of the polymer does not adversely affect the cleaning ability of dental ultrasonic scalers, the cleaning efficacy of a model system was examined. To this end, a fluorine varnish (Fluorprotector S) was stained with perylene dye (fluorescent red) (see Figure 5), and a zirconia model to be scaled was coated with the adjusted material. The coated and dried blocks were cleaned with either water or a formulated polyethylene oxide / water solution using a PIEZON handpiece. In both tests, the varnish could be quickly removed using the scaler unit within 30 seconds. This indicates that the use of the composition does not reduce the cleaning efficacy of the dental procedure.

[0097] Although the present disclosure has been described with respect to one or more particular embodiments and / or examples, it will be understood that other embodiments and / or examples of the present disclosure can be made without departing from the scope of the present disclosure. The present invention comprises the following: [1] A system for delivering an aqueous composition to a dental appliance, the system comprising: a reservoir containing one or more polymers selected from polyethylene oxide, xanthan gum, polyvinylpyrrolidone, alginic acid, hyaluronic acid, chondroitin sulfite, and combinations thereof; and a supply line in fluid communication with the reservoir, the supply line configured to deliver the one or more polymers from the reservoir to the dental appliance as a final concentration of the aqueous composition, wherein the total concentration of the one or more polymers is 0.01 to 5% by weight based on the total weight of the aqueous composition. [2] The system of [1], wherein the reservoir has an inlet configured to be connected to a dental unit water line. [3] The system described in [1], wherein the one or more polymers in the reservoir are in an aqueous composition at a first concentration, and the supply line is configured to connect to the dental unit water line to supply the aqueous composition to the dental unit water line. [4] The system of [3], further comprising a flow sensor configured to measure the flow of water in the dental unit water line. [5] The system described in [4], wherein the supply line further includes an actuator configured to vary the flow rate of the aqueous composition from the reservoir based on measured water flow in the dental unit water line. [6] The system described in [1], further comprising an ultrasonic scaler in fluid communication with the supply line, the ultrasonic scaler being supplied with a flow of aqueous composition at the final concentration. [7] A method for reducing or eliminating the formation of aerosol droplets during a medical or dental cleaning procedure, comprising: cleaning a treatment area of an individual with an aqueous composition comprising one or more polymers, said aqueous composition comprising 10 -3 ~10 3 Shear viscosity in poise and 10 2 ~10 7 A method for indicating the extensional viscosity in poise. [8] The method according to [7], wherein the extensional viscosity of the aqueous composition is 10 to 10,000 times the shear viscosity of the aqueous composition. [9] The method according to [7] or [8], wherein the total concentration of the one or more polymers is 0.01 to 5% by weight based on the total weight of the aqueous composition.

[10] The method according to any one of [7] to [9], wherein the one or more polymers are selected from natural polymers, synthetic polymers, or a combination thereof.

[11] The method according to any one of [7] to

[10] , wherein the one or more polymers are selected from polyethylene oxide, xanthan gum, polyvinylpyrrolidone, alginic acid, hyaluronic acid, chondroitin sulfite, and combinations thereof.

[12] The method according to any one of [7] to

[11] , wherein the aqueous composition further contains one or more additives.

[13] The method of

[12] , wherein the one or more additives are selected from hydrogen peroxide, antioxidants or antioxidant synergists, chelating agents, flavors, colorants, antimicrobial agents, preservatives, biofilm removers, particles, tartar or plaque staining dyes, wetting agents / detergents, and combinations thereof.

[14] The method according to any one of [7] to

[12] , further comprising the step of performing dental treatment using a dental instrument.

[15] The method according to

[14] , wherein the dental procedure is ultrasonic, rotary or dynamic cleaning, polishing, cavity preparation, fissure extension, root canal preparation, occlusion adjustment during restorative work or implants, or a process requiring air / water spray cleaning and / or particle abrasion.

[16] The method according to

[14] , wherein the dental instrument is an ultrasonic scaler.

[17] The method according to

[14] , wherein the dental instrument is a rotary instrument.

[18] A composition comprising water and one or more polymers, wherein the total concentration of the one or more polymers is 0.01 to 5% by weight based on the total weight of the composition, and the composition is 10 -3 ~10 3 Shear viscosity in poise and 10 2 ~10 7 A composition exhibiting an extensional viscosity of 1 poise.

[19] The composition according to

[18] , wherein the extensional viscosity of the composition is 10 to 10,000 times the shear viscosity of the composition.

[20] The composition according to

[18] or

[19] , wherein the one or more polymers are selected from natural polymers, synthetic polymers, and combinations thereof.

[21] The composition according to any one of

[18] to

[20] , wherein the one or more polymers are selected from polyethylene oxide, xanthan gum, polyvinylpyrrolidone, alginic acid, hyaluronic acid, chondroitin sulfite, and combinations thereof.

[22] The composition according to any one of

[18] to

[21] , wherein the aqueous composition further contains one or more additives.

[23] The one or more additives are selected from hydrogen peroxide, antioxidants or antioxidant synergists, chelating agents, flavors, colorants, antimicrobial agents, preservatives, biofilm removers, particulate, tartar or plaque staining dyes, wetting agents / detergents, and combinations thereof.

[22] The composition described in

[22] .

[24] A kit, in separate containers, comprising: a) one or more polymers; and b) an aqueous medium in an amount sufficient to mix with a) to prepare a composition comprising the one or more polymers, the composition comprising 10 -3 ~10 3 Shear viscosity in poise and 10 2 ~10 7 Shows extensional viscosity in poise, kit.

[25] The kit of

[24] , further comprising one or more additives selected from hydrogen peroxide, antioxidants or antioxidant synergists, chelating agents, flavors, colorants, antibacterial agents, preservatives, biofilm removers, particles, tartar or plaque staining dyes, wetting agents / detergents, and combinations thereof.

[26] The kit according to

[24] or

[25] , wherein the one or more polymers are selected from natural polymers, synthetic polymers, and combinations thereof, and the natural polymers are selected from polyethylene oxide, xanthan gum, polyvinylpyrrolidone, alginic acid, hyaluronic acid, chondroitin sulfite, and combinations thereof.

[27] The kit according to any one of

[24] to

[26] , further comprising one or more disposable items selected from a hose, a fitting, a container, an item for connecting a container containing the composition to a cleaning system, and combinations thereof.

[28] A composition comprising water and one or more polymers, wherein the total concentration of the polymers is 500 to 990,000 ppm, and when diluted 5 to 100 times with water, the composition has a viscosity of 10 -3 ~10 3 Shear viscosity in poise and 10 2 ~10 7 Shows extensional viscosity in poise, kit.

[29] The kit of

[28] , further comprising one or more additives selected from hydrogen peroxide, antioxidants or antioxidant synergists, chelating agents, flavors, colorants, antibacterial agents, preservatives, biofilm removers, particle, tartar or plaque staining dyes, wetting agents / detergents, and combinations thereof.

[30] The kit according to

[28] or

[29] , wherein the one or more polymers are selected from natural polymers, synthetic polymers, and combinations thereof, and the natural polymers are selected from polyethylene oxide, xanthan gum, polyvinylpyrrolidone, alginic acid, hyaluronic acid, chondroitin sulfite, and combinations thereof.

[31] The kit according to any one of

[28] to

[30] , further comprising one or more disposable items selected from a hose, a fitting, a container, an item for connecting a container containing the composition to a cleaning system, and combinations thereof.

[32] Use of one or more polymers to reduce or eliminate the formation of aerosol droplets during a medical or dental procedure, wherein the one or more polymers are used in the form of an aqueous composition, the aqueous composition comprising the one or more polymers, -3 ~10 3 Shear viscosity in poise and 10 2 ~10 7 Use of one or more polymers that exhibit an extensional viscosity of poise.

[33] Use of the polymer according to

[32] , wherein the extensional viscosity of the composition is 10 to 10,000 times the shear viscosity of the composition.

[34] The use of the polymer according to

[32] or

[33] , wherein the concentration of the one or more polymers is 0.01 to 5% by weight based on the total weight of the composition.

[35] The use of the polymer according to any one of

[32] to

[34] , wherein one or more polymers are provided in the form of a concentrate to be diluted before use.

[36] The use of the polymer according to any one of

[32] to

[35] , wherein the one or more polymers are selected from natural polymers, synthetic polymers, and combinations thereof.

[37] The use of a polymer described in any one of

[32] to

[36] , wherein the one or more polymers are selected from polyethylene oxide, xanthan gum, polyvinylpyrrolidone, alginic acid, hyaluronic acid, chondroitin sulfite, and combinations thereof.

[38] The use of the polymer according to any one of

[32] to

[37] , wherein the aqueous composition further comprises one or more additives.

Claims

1. 1. A system for delivering an aqueous composition to a dental appliance, comprising: a reservoir comprising one or more polymers selected from polyethylene oxide, xanthan gum, polyvinylpyrrolidone, alginic acid, hyaluronic acid, chondroitin sulfite, and combinations thereof; a supply line in fluid communication with the reservoir; the supply line is configured to supply the one or more polymers from the reservoir as a final concentration aqueous composition to a dental device; the total concentration of said one or more polymers is from 0.01 to 5% by weight, based on the total weight of said aqueous composition; the reservoir having an inlet configured to be connected to a dental unit water line; system.

2. A system for delivering an aqueous composition to a dental instrument, comprising: a reservoir comprising one or more polymers selected from polyethylene oxide, xanthan gum, polyvinylpyrrolidone, alginic acid, hyaluronic acid, chondroitin sulfite, and combinations thereof; a supply line in fluid communication with the reservoir; the supply line is configured to supply the one or more polymers from the reservoir as a final concentration aqueous composition to a dental device; the total concentration of said one or more polymers is from 0.01 to 5% by weight, based on the total weight of said aqueous composition; the one or more polymers of the reservoir are in an aqueous composition at a first concentration; the supply line is configured to connect to a dental unit water line to supply the first concentration aqueous composition to the dental unit water line; system.

3. further comprising a flow sensor configured to measure the flow of water in the dental unit water line. The system of claim 2 .

4. the supply line further comprising an actuator configured to vary the flow rate of the aqueous composition from the reservoir based on measured water flow in the dental unit water line. The system of claim 3 .

5. further comprising an ultrasonic scaler in fluid communication with the supply line; The ultrasonic scaler is supplied with a stream of the aqueous composition at the final concentration. The system according to any one of claims 1 to 4.

6. The aqueous composition comprises 10 －３ ~10 ３ poise shear viscosity and 10 ２ ~10 ７ indicates the extensional viscosity of poise, The system according to any one of claims 1 to 4.

7. the extensional viscosity of the aqueous composition is 10 to 10,000 times the shear viscosity of the aqueous composition; The system of claim 6.

8. The aqueous composition further comprises one or more additives. The system according to any one of claims 1 to 4.

9. the one or more additives are selected from hydrogen peroxide, antioxidants or antioxidant synergists, chelating agents, flavors, colorants, antimicrobial agents, preservatives, biofilm removers, particulate, tartar or plaque staining dyes, wetting agents / detergents, and combinations thereof; The system of claim 8.

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