AND DENTAL INSTRUMENTS

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the filing date benefit of ^' U.S. Provisional

Application No. 62/379,939, filed August 26. 2016, the entirety of which is hereby incorporated herein by reference.

BACKGROUND

[0002] For health and safety reasons, there is a need in medical and dental applications to regularly sterilize equipment, particularly before the equipment is next used on a patient or in a procedure, improperly sterilized instruments utilized in patient care can result in infection, e.g., at a surgical site, and pose a serious threat to the patient's safety that can lead to life-threatening infection, or even, death. There is also a need in other industries, such as food/beverage and agricultural industries, for regular sterilization of equipment.

[0003] in medical and dental applications, controlling infections is an important concern. Equipment contamination by blood or saliva can easily occur. For example, small , sharp instruments can become contaminated with blood or other fluids, providing ample opportunity for transmission of hepatitis B, hepatitis C and human immunodeficiency vires (HIV). Dentistry potentially exposes much of the population to blood contact with infected patients. Thus, the use of dental equipment may pose an unacceptable risk of cross infection.

[0004] In dentistry, re-sterilization of used instruments for reuse on another patient has been a common practice. Although, single-use devices have been promoted as a strategy to prevent cross-i nfection, among patients, re-sterilization of prev iously used instruments still continues to be a common practice because the cost of single-use devices can be significant.

[0005] The American Dental Association Guidelines emphasize the importance of dental instrument, sterilization, e.g., "All critical and semi critical dental instruments that are heat stable should be sterilized after each use by steam under pressure (antoelaving), dry heat, or chemical vapor. . . . Sterilization is recommended for all high-speed dental handpieces, low-speed handpiece components used immorally and reusable prophylaxis angles. It is important, to follow the manufacturers' instructions for cleaning, lubrication and sterilization procedures to ensure the eff ectiveness of the sterilization process and the longevity of these instruments. High-speed and low-speed handpieces produced today are heat tolerant, and many older heat sensitive models can be retrofitted with heat-stable components." [0006] The term ' ^' disinfection" is understood to be a process that kills only vegetative organisms, whereas, "sterilization" kills spores arid oilier microorganisms as well. Under current practices, sterilizing equipment is a time-consuming process thai requires careful attention. If strict protocols are not followed, the equipment may become

con laminated. For example, in an autoclave sterilization cycle, interruption of the cycle results in inadequately sterilized instruments thai cannot be considered safe After the sterilization cycle, the sterilizer must depressurize, and the packs remain in the sterilizer for drying. The drying phase may take an additional 20-45 min. The unit must only be opened after completion of the drying cycle making it more time consuming in field settings.

[0007] Heat sterilization methods are generally preferred to chemical disinfection. However, with certain instruments that are repeatedly used, frequent chemical disinfection may he necessary since heat sterilization can lead to corrosion. Further, it is often not possible to carry out heat sterilization due to time constraints and she need for access to autoclave equipment.

[0008] in these situations, disinfection using chemical disinfectants may be considered an alternate for heat sterilization to reduce the risk of cross contaminations.

Gluiaraldehyde is a dialdehyde that displays potent bactericidal, fungicidal, mycobactericidai, sponeida! and virucidal activities. The mechanism of its action is based on its interaction with amino groups in proteins and enzymes. Glutaraldehyde is normally used as a 2% solution, which is sufficient to achieve a sporicktel effect, it is used as an immersion solution for metallic instalments, face masks, heat sensitive plastic rubbers, and fiber optics.

[0009] Hydrogen peroxide (Η_·0>) is also used for disinfection, sterilization, and antisepsis and is effective against bacteria, viruses, yeast and spores, fi is commercially available in concentrations ranging from 3% to 90%. ¾<¾ is environmental friendly, because it can rapidly degrade into harmless products - water and oxygen. H^O? acts as an oxidant by producing hydroxy! free radicals (·ΟΗ), which attack ceil components, including lipids, proteins, and DNA. A proposed mechanism of action is based on its ability to target exposed sulmydry! groups and double bonds.

[0010] Alcohol is an effective skin antiseptic and disinfectant for medical instruments. A number of alcohols have shown effective antimicrobial activity but, ethyl alcohol, Lsopropyi alcohol and n-propanoi are the most widely used. Alcohols exhibit rapid broad-spectrum airtimicrobial activity against vegetative bacteria (including mycobacteria), fungi, and viruses but they lack sporicidal activity hence are not recommended for sterilization, in general, the antimicrobial activity of alcohols is optimum in the range of 60- 90%, but it becomes significantly lower at concentrations below 50%. The exact mode of action of alcohols is unclear, but it is generally believed that they cause membrane damage leading to cell lysis and result into a rapid denaturaiion of proteins,

SUMMARY

[0011] Chemical disinfectant technology offers advantages over other methods, such as heat sterilization, but can be less effective. Although a significant reduction in total viable count can be observed with these known chemical disinfectants, it would be desirable to eliminate the viable micro-organisms to an even greater degree, and with an easier and more practical method. In. summary there is a need for chemical disin.fectkm/sieriikation for dental and medical tools, or other workpieees and equipment, e.g.. to avoid the spread of infectious diseases.

[0012 ] According to one aspect of this disclosure, there is provided a device for sterilizing or disinfecting a workpiece. T he device can include a chamber that defines an interior treatment space, where the chamber can receive the workpiece when the chamber is opened and can be sealed when the chamber is closed. A chlorine dioxide gas source is provided to supply chlorine dioxide gas to the chamber when the chamber is closed. And the device fills the interior treatment space of the chamber with chlorine dioxide gas when the chamber is closed at least unti l the chlorine dioxide concentration reaches a predetermined threshold concentration .

[0013] According to another aspect, there is provided a device for sterilizing or disinfecting a workpiece where the device includes a chamber defining an interior treatment space and the chamber is configured to: (i) be able to receive the workpiece when the chamber is opened, (ii) be sealed when the chamber is closed, and (in) receive chlorine dioxide gas from a chlorine dioxide gas supply. The device can include a sensor that detects at least one of (i) chlorine dioxide concentration in the interior treatment space, and (ii) pressure in the interior treatment space. The device can further include a controller thai is configured to receive information from the sensor and control an amount of chlorine dioxide gas that is suppl ied to the chamber based on the information that is received from the sensor.

[001.4] According to another aspect, there is provided a method for treating a workpiece to sterilize or disinfect the workpiece. The method includes steps of introducing the workpiece into a scalable chamber that defines an interior treatment space, sealing the scalable chamber, then filling the interior treatment space with chlorine dioxide gas, and maintaining a concentration of chlorine dioxide in the sealed chamber of at least 1 mg. L for at least two mi mites. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Fig. I is a .schematic diagram of a steriHzation/disinieetant device according to one embodiment of the invention; and

[0016] Fig. 2 is a schematic diagram of a control system that can be used with the sierilization/dismfeeiani device.

DETAILED DESCRIPTION OF EMBODIMEN TS

[0017] Aspects of this disclosure relate to the use of chlorine dioxide gas to disinfect or steril ize equipment, tools, medical supplies, fluid lines, dressings and other work pieces. This application describes devices, methods, and systems for these disinfection and sterilization applications.

[0018] in one aspect, the chlorine dioxide can be generated as described in U.S. Patent Application Serial No. 14/878,603 , filed on October 8, 20 ! 5 (published as U.S. Patent Application Publication No. 2016/0251 219), the entirety of which is incorporated herein by reference. Under this procedure, chlorine dioxide gas can be generated by reacting ozone gas with a solid chlorite media, and the chlorine dioxide that is produced can be used as a disinfectant or sterilizing agent either in gaseous form or dissolved in water. This chlorine dioxide generation method is referred to herein as the "clozone" mechanism.

[0019] Fig. 1 is a schematic diagram that shows a device 100 for sterilization and/or disinfection according to one embodiment of the invention. The device can include an air compressor 1 10 that receives atmospheric atr 1 05 and generates compressed air 1 15. The compressed air 1 15 is delivered to an ozone generator 120 that generates ozone gas 1:25. As an alternative to the air compressor 1 10, an oxygen generator may be used that generates purified oxygen that is then supplied to the ozone generator 120. lite ozone gas 125 is contacted with solid chlorite media 130 to generate chlorine dioxide gas 135. The solid chlorite media 130 can be provided as ei.dome-eontaini.ng pellets or beads (e.g., containing Na ClOa) in a cartridge or column that, allows ozone gas to enter the cartridge and allows product gases, including chlorine dioxide, to exit the cartridge. This elozone mechanism can produce very pure chlorine dioxide gas, e.g., higher than 75 wt. % excluding any carrier gas that is included. In some aspects, the invention can include other mechanisms that generate chlorine dioxide gas, particularly those that generate the gas on-site, and on-demand for disinfectant and sterilization.

[0020] The device 100 can include probe chamber 140 thai can be open and closed. When opened, the chamber 140 is configured to be able to receive workpieces. For example, the chamber 140 may include a lid, door, or clam-shell type structure thai is opeoahie and closeable, and preferably can be secured in the closed position with a latch, lock, or interference fit. When closed, the chamber 140 can be scaled to the environment and can define an internal treatment space to which the chlorine dioxide gas 1 35 is fed to disinfect or sterilize workpieces. The chamber 140 is preferably sealed air-tight from the exterior when it is closed. The interior treatment space of chamber 140 can include sites for holding a single workpiece or multiple workpieces, such as medical and dental equipment. Each holding site can be configured to hold or grip a portion of the workpiece. As one example, the holding sites can be arranged in a row or group, like a rack that is configured to hold multiple instruments.

[0021] The chamber 140 can be equipped with one or more sensors 170 including one or more of a chlorine dioxide sensor, a humidity sensor, and a pressure sensor. The chamber 140 can further include a sensor that senses when the chamber is open to the outside environment or closed, and a sensor that can sense whether there is a workpiece being held in the chamber (e.g., with a weight sensor, contact sensor, capacitance sensor, or the like). The sensors can be connected to communicate with a control system .180 {e.g., by being hardwired or wirelessly connected over communication pathway 175).

[0022] The control system I SO is iifustrated schematically in Fig. 2. The control system 180 can include a controller such as processor (e.g., CPU 205), a memory 215 such as a bard drive or flash drive, which may include ROM memory, and a timer 225. The timer 225 can include a quartz clock, for example. The CPU 205 can communicate with a display 230. The device 100 can include a user interface 235 as part of the display 230 or as a separate interface, e.g. , on the chamber 140. The CPU can also communicate with a light display 240 that includes various lights (e.g., LED) to visually indicate the status of treatment, e.g., a specific light, color, or other indicia can indicate on -going treatment, time to end of treatment, completion of treatment period, storage, not treated, etc. ). The light display 240 can be positioned on the probe chamber 140, for example.

[0023] To disinfect or sterilize a workpiece, the control system I HO can activate chlorine dioxide gas generation, e.g., by sending "ON" signals to the air compressor 1 10 and the ozone generator 1 20 via respective communication pathways .188 and 186. The chlorine dioxide gas generation can be controlled to fill the sealed chamber 140 with chlorine dioxide gas until the chlorine dioxide level in the chamber 140 reaches a predetermined threshold concentration, e.g. , at least 1 mg/L to 2,000 mg/L, at least 5 mg/.L to 1 ,000 mg/L, at least 10 mg/L to 500 mg/L, at least 25 mg/L to 250 mg/L, or at least 50 mg/L to 200 mg/L. [0624] The control system I SO can continue to control the concentration of chlorine dioxide in die chamber based on information from sensor 170, such as chlorine dioxide sensor, so that die chlorine dioxide gas can be maintained in the chamber at a minimum threshold concentration. For example, where a eiozone reaction mechanism is employed, the control system 180 can control the amount of ozone produced by the ozone generator 1 20 by changing the voltage to the ozone generator 120 by sending signals via communication pathway 1 86, and by controlling the amount of oxygen fed to the generator 120, e.g., by controlling the output of the air compressor 1 10 v ia communication pathway 188.

[0025] Increasing the amount of ozone will increase the amount of chlorine dioxide gas that is generated, which allows the chlorine diox ide concentration in the chamber .140 to be quickly controlled. This control can be performed automatically by the control system 1 80 using a control loop feedback mechanism, such as a P!D controller. Aspects of this invention may allow ¹ the target concentration in the chamber to be reached in a manner of minutes, e.g. , depending on the chamber volume, from 10 seconds to 45 minutes, from 30 seconds to 30 minutes or from i to 15 minutes.

[0026] The pressure in the chamber can also be controlled automatically in a similar manner by using a pressure sensor that, communicates with the control system 180 so that the ch!onne dioxide generation is controlled to achieve die desired pressure, in this way, the chlorine dioxide concentration in chamber 140 could also be controlled by using only information from the pressure sensor.

[0027] In one aspect, the pressure can also be controlled with a pressure relief valve .150 that allows pressure in the chamber to build up to a desired threshold pressure when the chamber is filled with chlorine dioxide gas, and which releases gas 155 in any amount necessary to maintain the threshold pressure. When filled with chlorine dioxide gas, the pressure in the chamber 140 can be kept at atmospheric pressure, or desirably slightly above atmospheric pressure, e.g., at least 1 psi, 5 psi, or 1 -10 psi over atmospheric pressure. Maintaining a slight back pressure in the chamber 140 in this manner can increase the effectiveness of the chlorine dioxide in sterilizing or disinfecting the workpiece because, e.g., it can force the gas into crevices and cracks of the workpiece and ensures that the entire chamber is filled with chlorine dioxide gas at the desired concentration,

[0028] The pressure relief valve 150 can be connected to a gas scrubber 160 that adsorbs or neutralizes the chlorine dioxide in gas 155. The scrubber 160 can be a container that includes activated carbon, for example. The scrubber 160 turn likewise be connected to an evacuation line 145 to evacuate the chlorine dioxide gas from the chamber 140 before opening the chamber so that the sterilized or disinfected vvorkpieces can be safely removed.

[0029] The humidity in the chamber can be separately controlled based on information from the humidity sensor. It may he desirable in some circumstances to maintain a somewhat humid environment in the chamber when treating the workpiece to sterilize or disinfect it. in this regard, the humidity may condense on hard surfaces of the workpiece and act as a vehicle in which the chlorine dioxide dissolves in the condensate and disinfects the surface.

[0030] The control system 180 can include a timer 225 that can keep track of the sterilization or disinfecting time, i.e., the time that has elapsed since the chlorine dioxide reached the target concentration and/or pressure. The CPU 205 can send signals causing an audio alert, or visual alert (e.g., on the user interface 235 or light display 240 on the device) when the desired sterilization, or disinfecting treatment period is complete. Suitable periods will depend on the application and the desired level of sterilization, but may be in the range of from 2 minutes to three hours, from 10 minutes to two hours, or from 30 minutes to one hour, for example.

[0031 ] In some embodiments, the chamber 140 can be used for storing vvorkpieces in the presence of chlorine dioxide gas until they are needed for use. During such storage, the concentration and/or pressure of chlorine dioxide in the chamber can be maintained at tire same or different values as that used during the sterilization/disinfection step. For example, the CPU 205 can automatically terminate the sterilization/disinfection step after a threshold time has elapsed, and control the chlorine dioxide generation and/or air compressor output to change the environment from a treatment concentration/pressure to a storage concentration/pressure. The storage concentration of chlorine diox ide may be less than the treatment concentration of chlorine dioxide.

[0032] in this regard, air 190 can be supplied directly from the air compressor 1 10 to chamber 140 (separately from the ozone generator) to reduce the concentration of chlorine dioxide in the chamber 140 after the sterilization/disinfecting step, to evacuate the chamber, or reduce the concentration to a suitable storage concentration. The user interface can include an input for instructing the chamber .140 to evacuate the trapped chlorine dioxide gas via line 145 so that a workpiece can be safely removed.

[0033] if the chamber 140 includes sites for holding more than one workpiece, the chamber 140 can include a plurality of chambers or the chamber 140 can be divided into one or more discrete subehambers, where chlorine dioxide is fed to each chamber separately from the chlorine dioxide generation unit, e.g., through a manifold that has a line and valve to each subcharnber, and where the valves are connected to the control system. Under such a configuration, one chamber can hold a workpiece in an environment with a storage concentration of chlorine dioxide while another chamber is treating a second workpiece in an environment with a treatment concentration of chlorine dioxide.

[0034] The ability to store a workpiece in a chlorine dioxide-containing atmosphere is advantageous because the user has confidence that the workpiece is sterile (or disinfected) when the user removes tt from the chamber tor use. In this regard, in known disinfectant systems, the workpiece is removed upon completion of treatment and may be stored in conditions that compromise the disinfectant treatment until it is later used. This can be particularly problematic with liquid media disinfection solutions because liquid can remain on the workpiece after being removed from the device, which can promote microbial growth. Also, by storing ihe workpiece in a chlorine dioxide-containing atmosphere, the storage period can be relatively lengthy while maintaining an atmosphere that prevents microbe growth. In some aspects, the storage period may be at least up to one week, up to three days, or from 2 hours to 1 day.

[0035] The sterilization/disinfection device described herein can further be provided with a mechanism to track and record information about the disinfection/sterilization of a specific workpiece. For example, the device 100 can include a laser scanner 250 that scans a barcode on a workpiece and then records in the memory 2 15 (i) whether thai specific workpiece has been treated, (it) for how long, t iii) the treatment conditions (chlorine dioxide concentration and pressure), (iv) the storage time and conditions, (v) etc. Equivalent track ing systems such as employing RF.ID chip on the workpiece and a reader on the sterili/ation/disinfectant device can also be used. T he information that is specific to status of the workpiece can be recorded in memory 215 and retrieved by the user at the user interface 235 or on separate display so that the user has confidence that the workpiece is suitable for use.

[0036] in one aspect, the invention allows many of the above steps to be automated. For example, the device 100 may detect when a workpiece has been inserted into the chamber 140, and automatically begin a treatment cycle, and when the treatment cycle is complete it can automatically begin a storage cycle. The conditions in the chamber 140 can also be automatically controlled using control feedback mechanisms, as described above.

[0037] Using a gaseous disinfectant medium that can. be generated on-site and can be provided on-demand has several advantages: ● The use of a gaseous medium, particularly gas that is generated on-site, allows for any sized chamber to be used in connection with the invention. in this regard, even large chambers can be readily filled to the desired concentration, which allows for large workpieces to be disinfected or allows a large number of •workpieces to be simultaneously disinfected. Suitable treatment chambers may have a volume in the range of, for example, from 10 ml to 50 L, from 100 ml to 10 L, from 500 ml to 5 L, or from 750 ml to 3 L.

● The chlorine dioxide can be quickly generated (e.g. , at a rate of at least 0.5 g/hour, at least 1 g/hr, at least 10 g/hr, or 5-20 g/hr), and the chamber can be quickly filled at a precise pressure and concentration. The concentration and pressure can be determined empirically, for example, based on the levels that, show required efficacy against certain microbes of interest for a given application or for the type of equipment thai is being disin fected. The memory 21.5 can store a database of concentrations and/or pressures of chlorine dioxide that are effective against specific microbes (i .e., the values that show microbe concentrations at less than a predetermined threshold value for a given treatment time), and the control system 1 80 can be configured to retrieve this recorded information and control the chamber to achieve these conditions based on input front a user regarding, e.g., the level of disinfection/sterilization that is needed.

● The chlorine diox ide generation unit can be a sustainable portable unit that comprises, in the c!ozone method, the air compressor 1 .10. the ozone generator 120, and the chlorite media 130. The portable unit can be linked to a host system including, e.g., the probe chamber 140, control system I SO, etc. to provide onsite antimicrobtal/biocide gas, The chlorite media can be provided in a cartridge that is replaceable as the media is depleted.

● The chlorine dioxide allows for sterilization/disinfection at low temperatures (typically less than 35T. less than 30°C, from 20-25 ^V C, or room temperature), and thus allows for treatment of workpieces that cannot be sterilized at higher temperatures, such, as in an autoclave. This may include workpieces with polymeric parts, thin films, nonwoven materials, fibrous materials, etc.

● Using a tracking system as described above can provide a foolproof mechanism for ensuring that workpieces are sterilized or disinfected to the desired level. Current systems are manual, and chemical indicators are required to show that treatment is complete. By using a gaseous disinfectant media with tracking and ihe ability to store the treated workpiece, less human interaction is required as compared to liquid media. For example, using chlorine dioxide gas prevents the need to rinse the workpiece, which is required when liquid chemicals are used. The storage and tracking system described above also provide an automated system, not practical will) liquid media, that reduces errors.

[0038] This disclosure has been presented for purposes of illustration and description and is not intended to be exhaustive or limiting. Modifications and variations will be apparent to those of ordinary skill in the art, while still practicing the inventions defined in the claims. The embodiments were chosen and described in order to explain principles and practical applications, and to enable others of ordinary skill m the art to understand the disclosure for various embodiments with various modifications as are suited to the particular use contemplated.