WO2019023407A1 - Ozone aqueux et gazeux destiné au retraitement d'endoscopes et d'autres instruments et appareils médicaux et dentaires - Google Patents

Ozone aqueux et gazeux destiné au retraitement d'endoscopes et d'autres instruments et appareils médicaux et dentaires Download PDF

Info

Publication number
WO2019023407A1
WO2019023407A1 PCT/US2018/043793 US2018043793W WO2019023407A1 WO 2019023407 A1 WO2019023407 A1 WO 2019023407A1 US 2018043793 W US2018043793 W US 2018043793W WO 2019023407 A1 WO2019023407 A1 WO 2019023407A1
Authority
WO
WIPO (PCT)
Prior art keywords
ozone
endoscope
aqueous
channel
appliances
Prior art date
Application number
PCT/US2018/043793
Other languages
English (en)
Inventor
Benedict B. St. Onge
David J. Mishelevich
Rodger D. Thomason
James E. Shenberg
Original Assignee
Therozone Usa, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Therozone Usa, Inc. filed Critical Therozone Usa, Inc.
Publication of WO2019023407A1 publication Critical patent/WO2019023407A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/18—Liquid substances or solutions comprising solids or dissolved gases
    • A61L2/183—Ozone dissolved in a liquid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C19/00—Dental auxiliary appliances
    • A61C19/002—Cleaning devices specially adapted for dental instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/20—Gaseous substances, e.g. vapours
    • A61L2/202—Ozone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/24—Apparatus using programmed or automatic operation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M39/16—Tube connectors; Tube couplings having provision for disinfection or sterilisation
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B25—HAND TOOLS; PORTABLE POWER-DRIVEN TOOLS; MANIPULATORS
    • B25J—MANIPULATORS; CHAMBERS PROVIDED WITH MANIPULATION DEVICES
    • B25J21/00—Chambers provided with manipulation devices
    • B25J21/02—Glove-boxes, i.e. chambers in which manipulations are performed by the human hands in gloves built into the chamber walls; Gloves therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/70—Cleaning devices specially adapted for surgical instruments
    • A61B2090/701—Cleaning devices specially adapted for surgical instruments for flexible tubular instruments, e.g. endoscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10—Apparatus features
    • A61L2202/12—Apparatus for isolating biocidal substances from the environment
    • A61L2202/121—Sealings, e.g. doors, covers, valves, sluices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10—Apparatus features
    • A61L2202/12—Apparatus for isolating biocidal substances from the environment
    • A61L2202/123—Connecting means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10—Apparatus features
    • A61L2202/13—Biocide decomposition means, e.g. catalysts, sorbents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10—Apparatus features
    • A61L2202/14—Means for controlling sterilisation processes, data processing, presentation and storage means, e.g. sensors, controllers, programs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10—Apparatus features
    • A61L2202/17—Combination with washing or cleaning means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20—Targets to be treated
    • A61L2202/24—Medical instruments, e.g. endoscopes, catheters, sharps
    • G—PHYSICS
    • G05—CONTROLLING; REGULATING
    • G05B—CONTROL OR REGULATING SYSTEMS IN GENERAL; FUNCTIONAL ELEMENTS OF SUCH SYSTEMS; MONITORING OR TESTING ARRANGEMENTS FOR SUCH SYSTEMS OR ELEMENTS
    • G05B2219/00—Program-control systems
    • G05B2219/30—Nc systems
    • G05B2219/45—Nc applications
    • G05B2219/45118—Endoscopic, laparoscopic manipulator

Definitions

  • Described herein are systems and methods for high-level-disinfection and sterilization reprocessing of dental and medical instruments and appliances including endoscopes.
  • Cold methods are utilized in dental offices, medical offices, hospitals, ambulatory surgical centers and other healthcare facilities for the high-level disinfection or sterilization of instruments or reusable appliances that could be damaged by sterilization using autoclaving.
  • Current cold, high-level disinfection methods use harsh chemicals requiring disposal into the environment waste system.
  • Our method uses a temporary chemical that reverts back to benign substances after serving its purpose as a disinfectant.
  • This patent application deals with the categories of high-level disinfection and sterilization.
  • instruments and appliances include dental-impression trays, bronchoscopes, endotracheal tubes, laryngeal blades, sinuscopes, manometry probes, flexible endoscopes, prostate ultrasound probes, tonometers, anorectal manometry catheters, and diaphragm fitting rings.
  • High-level disinfection solutions utilized for medical and dental instruments and appliances vary widely; typical ones include Glutaraldehyde, Phtharal
  • Disinfection solutions utilized vary widely; typical ones include Glutaraldehyde, Phtharal (Phthalaldehyde), Peracetic acid, highly-acidic electrolyzed water (EOW), Aldehyde-based disinfectants, Hypochlorous acid (superoxidized water), Chlorine Dioxide, and Alcohols
  • ENDOSCOPE published March 7, 1990, describes an endoscope reprocessor with an aqueous- ozone-as-active-agent mode.
  • Takahashi et al. Japanese Patent Number JP3945222, entitled “WASHING METHOD FOR ENDOSCOPE AND ITS DEVICE” published November 2, 2001, describes a device where one compartment is used for the generation of aqueous ozone and a second compartment used for washing the endoscope with that aqueous ozone.
  • APPARATUS published August 5, 2010, also describes a method for sterilization starting out with applying a vacuum, humidifying the chamber, and then introducing gaseous ozone in a chamber with a humidity level in the range of 75-100%, but preferably minimally of 85%.
  • WASHING APPARATUS describes a device for washing an endoscope with a liquid sterilant (with the ability to shine ultraviolet light on the device being reprocessed) that includes gaseous ozone for dehydrating or drying the endoscope.
  • DISINFECTION OF OBJECTS, DEVICES, AND AREAS that describes a chamber with an associated applied-agent generator producing a mixture of acidic oxidizing compounds (preferably hydrogen peroxide and peroxyacetic acid).
  • the description also includes a porous and/or permeable interface to endoscopes for reprocessing of those devices.
  • the present invention is a system for high-level disinfection or sterilization of instruments and appliances in medical facilities and dental practices using aqueous ozone.
  • dental offices in the U.S. have replaced may of their reusable appliances with equivalent disposables, this is not true in some other parts of the world where there are significantly increased cost concerns.
  • the present invention includes an Automated Endoscope Reprocessing (AER) device for flexible, semi-rigid, and rigid endoscopes using ozone is both aqueous and gaseous forms as the active agent and applies these in a manner that simplifies the high-level disinfection process to encourage compliant, effective application.
  • AER Automated Endoscope Reprocessing
  • the devices can be applied to rigid and semi-rigid endoscopes as well.
  • Cycle times on the order of 20-60 minutes (on the order of 20-40 minutes for endoscopes) are comparable or better than chemical methods, but not restricted to this range.
  • Our approach is definitely faster than some approaches using chemical methods that may require up to ten hours of instrument or appliance immersion.
  • the invention devices presently covered do not depend on heat above room temperature at any point in the process nor are post-processing chemicals like alcohol required to remove chemical residue; in fact, the disinfected instruments or appliances, including endoscopes, do not need to be rinsed.
  • a benefit of the approach is that it offers a non-biohazardous green solution in that the by-products of aqueous ozone are oxygen and water and gaseous ozone is oxygen.
  • FIG. 1 shows a block diagram of an ozone-based Endoscope Reprocessing System.
  • FIG. 2 illustrates an embodiment of an ozone-based automated endoscope reprocessor based primarily on aqueous ozone.
  • FIG. 3A shows an end of a typical endoscope
  • FIG. 3B illustrates a device for capturing an end of an endoscope in such a matter as to prevent surfaces of the reprocessing device from being in constant contact with the endoscope surface.
  • FIGS. 4A- 4B show two alternative embodiments of a mechanism within an upper tank to prevent surfaces from being in constant contact with the endoscope;
  • FIG. 4A illustrates alternating parallel plates and
  • FIG. 4B a wave trough.
  • FIGS. 5 A- 5E illustrate mechanisms within a vertical container for an endoscope probe shaft to prevent surfaces from being in constant contact with the device;
  • FIG. 5A shows a rib embodiment
  • FIG. 5B the embodiment of FIG. 5 A with a rotating mechanism
  • FIG. 5C an undulating accordion wall
  • FIG. D an embodiment using injection and retraction of fluid
  • FIG. 6 illustrates a block diagram of the automated reprocessing device controller primarily based on aqueous ozone.
  • FIG. 7 shows a set of pseudo code for operating the automated aqueous-ozone endoscope processor.
  • FIG. 8A illustrates an embodiment of an ozone-based automated endoscope reprocessor based primarily on gaseous ozone.
  • FIG. 8B shows the trumpeting mechanism for control of ozone flow through endoscope paths and mechanism for checking individual channels for contamination.
  • FIG. 9 illustrates a block diagram of the automated reprocessing device controller based on gaseous ozone.
  • FIG. 10 shows a set of pseudo code for operating the automated gaseous-ozone endoscope processor.
  • FIG. 11 illustrates an embodiment of an aqueous-ozone manual reprocessor.
  • FIG. 12 illustrates a block diagram of the manual-reprocessing device controller.
  • FIG. 13 shows a set of pseudo code for operating the manual aqueous-ozone endoscope processor.
  • FIG. 14 shows a block diagram of an ozone-based medical and dental instrument and appliance reprocessing system.
  • FIGS. 15A - 15B illustrate embodiments of the ozone -based automated instrument and appliance reprocessor based on aqueous ozone.
  • FIG. 15A shows a version where an anti-constant contact is implemented as alternating sets of plates within vertical pairs.
  • FIG. 15B shows a version where an anti-constant contact is implemented as a rotating cage wheel that carries instruments and appliances up to the point where they fall off supports and drop through the aqueous ozone.
  • FIGS. 16 A- 16D show alternative embodiments of mechanisms within the tank to prevent surfaces from being in constant contact with instruments and/or appliances.
  • FIG. 16A shows vertical pairs of plates with alternating motion.
  • FIGS. 16B and 16B illustrate an embodiment using a link belt.
  • FIG. 16C illustrates a plan view of the link belt.
  • FIG. 16D shows an implementation using rollers.
  • FIG. 17 illustrates a block diagram of an automated reprocessing device controller.
  • FIG. 18 shows a set of pseudo code for operating the automated aqueous-ozone reprocessor.
  • FIG. 19 illustrates an embodiment of an aqueous-ozone manual reprocessor.
  • FIG. 20 illustrates a block diagram of the manual-reprocessing device controller.
  • FIG. 21 shows a set of pseudo code for operating the manual aqueous-ozone instrument and appliance processor.
  • FIG. 22 illustrates a recirculating ozone-infusion system with its coupling device.
  • FIG. 23 shows an ozone infusion system for gaseous ozone.
  • FIG. 24 illustrates the recirculating ozone-infusion system with its coupling device that also can incorporate provision of gaseous ozone.
  • FIG. 25 illustrates the coupling mechanism of the coupling of the aqueous-ozone recirculating bottle to the channels to and from a given reprocessor.
  • FIG. 26 illustrates, in assembled form, the coupling mechanism of the coupling of the aqueous-ozone recirculating bottle to the channels to and from the given reprocessor.
  • FIG. 27 illustrates, in assembled form, an ozone-generator side of the coupling mechanism of the coupling of the aqueous-ozone recirculating bottle.
  • FIGS. 28A- 28C show three cases of bubble inclusions causing voids in surface access.
  • FIG. 28A shows the bubble at a straight junction
  • FIG. 28B illustrates a bubble at a right-angle junction
  • FIG. 28C shows bubbles present in a gasket/O-ring interface.
  • FIG. 29 illustrates a set of steps for reprocessing using a combination of aqueous and gaseous zone.
  • FIGS. 30A- 30B show graphs of considerations related to material compatibility.
  • FIG. 30A illustrates a general schema for regions of sufficient kill versus too much material damage and
  • FIG. 30B shows schemes at different kill levels, Log 5 Kill and Log 6 Kill.
  • FIG. 31 illustrates a profile of ozone when a thin film of aqueous ozone is exposed to gaseous ozone.
  • the invention is an aqueous-ozone-based or aqueous- and gaseous-ozone-based device for automated medical and dental instrument and appliance reprocessing using high-level disinfection or sterilization.
  • a manual-reprocessing version is covered as well.
  • endoscope reprocessing a two-compartment device is incorporated for the Automated Endoscope
  • Reprocessing with a manual-processing embodiment involving a single compartment covered as well A feature common to all embodiments is that gaseous ozone produced in an ozone generator is bubbled through water to produce aqueous ozone sometimes referred to as a green solution.
  • aqueous ozone negative pressure in chamber(s) preventing gas leaks in an operating room with a vacuum pump and ozone destruct for ozone-vapor handling, 120/240 Volt alternating current at 50/60Hz operation, Ground Fault Circuit Interrupter (GFCI) to internal enclosure so no chance of harm to operator with wet hands on device that shuts device down if grounded plug fails, sealed enclosures to maintain small delta pressure between internal/external atmosphere, ozone destruct, ozone-gas sparger placed at the lowest point of the system, thermal subsystem, and concentration of aqueous ozone between 2 ppm and 5 ppm (although not restricted to this range) for, either automated or manual reprocessing.
  • GFCI Ground Fault Circuit Interrupter
  • gaseous ozone for instrument and appliance contact is utilized as well.
  • Endoscopes processed will be in the range of 3mm to 20mm in diameter and 10cm to 200cm in length (but not restricted these ranges).
  • a design consideration is that the diameter of the container for probe-shaft and its length will allow essentially any endoscope configuration to be accommodated.
  • Liquid is designated as water (distilled, de-ionized, sterile, etc.) in the various descriptions for simplicity, but could be another fluid. All materials that would be exposed to ozone need to be resistant to disintegration, examples of which are stainless steel, Teflon®, being Kynar®, and silicone rubber. A sensor can be placed so an operator cannot turn ozone generation on unless there is an appropriate amount of liquid in place. In like manner, door interlocks can be placed to prevent opening unless the ozone has been dissipated; this would be mediated in software for safety of an operator. For all embodiments there is a need to pre-clean the instruments or appliances undergoing high-level disinfection or sterilization.
  • Each embodiment includes an ozone destruct to prevent release of gaseous ozone into the environment.
  • the ozone destruct is a destruction canister containing a catalyst, chemical, or absorbent for collection and or decomposition the ozone to regenerate oxygen to be discharged from the canister.
  • Additional embodiments can include sensor monitors to assess the flow of instruments, including endoscopes, and appliances during the high-level disinfection or sterilization process, information systems to track the specific barcoded or other identifications of instruments and appliances being processed for inventory tracking, troubleshooting, or other functions such as setting operational parameters for given instruments, including endoscopes, and appliance types, and drying with air and/or gaseous ozone.
  • sensor monitors to assess the flow of instruments, including endoscopes, and appliances during the high-level disinfection or sterilization process
  • information systems to track the specific barcoded or other identifications of instruments and appliances being processed for inventory tracking, troubleshooting, or other functions such as setting operational parameters for given instruments, including endoscopes, and appliance types, and drying with air and/or gaseous ozone.
  • an adapted T-8000 US Patent 9,220,800
  • ozone gas supply or alternatively there would be a separate unit that encloses the majority of T-8000 components.
  • a key feature of this invention is that in contrast with chemical methods of endoscope reprocessing, the ozone approaches inherent in this invention will reduce or eliminate biofilm on the reprocessed surfaces by attacking polysaccharides.
  • FIG. 1 shows a block diagram of the ozone-based Endoscope Reprocessing System. At this level, the diagram is applicable to either an automated or manual system.
  • the reprocessing of the endoscope to undergo high-level disinfection is performed in endoscope reprocessor 100.
  • Controller 110 performs the overall control of the system. Controller 110 provides instructions to the ozone generator 120 that includes the mechanical ozone-coupler connection to endoscope reprocessor 100 via channel 105. Controller 110 provides instructions to endoscope reprocessor 100 through channel 115.
  • Ozone generator 120 with its coupler can have its input as either ambient air or medical-grade oxygen provided by optional oxygen source 130 that provides oxygen to ozone generator 120 through channel 125.
  • Input to the ozone generator 120 is best at minus 20 degC dew point or better that allows low nitric oxide production so increased equipment life is facilitated.
  • Optional oxygen source could also be processed air from a swing separator, typically 85% to 95% oxygen.
  • the concentration of oxygen going into ozone generator 120 will be in the range of 20% to 100%.
  • Ozone generator 120 delivers ozone via channel 135 to reprocessor 100.
  • the temperature of the aqueous-ozone fluid in reprocessor 100 is controlled by thermal subsystem 140 through channel 145. Temperature will ideally be maintained between 0 and 25degC, but not restricted to this range.
  • Gaseous ozone coming off the surface of the liquid in endoscope reprocesser 100 100 is routed through ozone destruct 150 through channel 155 that includes a vacuum system to draw off the ozone.
  • the vacuum system will operate at a low l-5mm Hg.
  • Ozone destruct 150 ensures that operators are not exposed to gaseous ozone during endoscope reprocessing.
  • Ozone destruct 150 will normally be constructed using metal oxides to prevent CO production.
  • any residual ozone is likely to be at low concentration, at or below 0.1 ppm, considered insignificant as to biological impact. The value can be measured to see if it might be of some concern in a particular wastewater situation. If a facility wants to make sure that there is definitely no ozone being disposed of, the waste stream can be heated to 40°C, be treated with ultraviolet light, or be treated with an ozone-consuming substance.
  • FIG. 2 illustrates an embodiment of the ozone-based automated endoscope reprocessor primarily using aqueous ozone as the high-level disinfection agent.
  • Upper tank 200 is filled with aqueous-ozone liquid 205 with liquid surface 210.
  • Bottom of upper tank 200 should be a gradual cone shape to catch any debris indicating further investigation of previous cleaning operation is needed.
  • Temperature of the fluid is regulated by thermal subsystem 215 to 0-25degC (but not restricted to this range).
  • Automated endoscope reprocessor subsystems such as liquid stirrer motor 220 (and associated stirrer blade 225), thermal subsystem 215, and anti-constant-contact subsystem 260 are instructed by channel 265 that provides communications to and from the device controller (not shown).
  • Endoscope head 235 has connected elements endoscope-probe-shaft 250 that is inserted though orifice seal 255 into probe-shaft container 230 and endoscope cable 240 in upper tank 200 aqueous-ozone liquid 205 that terminates in endoscope connector assembly 245 that provides interfaces to the endoscope camera, light source, vacuum, air source, electrical-interface, and any other on existence or subsequently developed.
  • Orifice seal 255 incorporates a fluid-flow restriction (in the range of 10% to 90% but typically 70%) of fluid passing from probe-shaft container 230 to upper tank 200 with the rest of the fluid passing from probe-shaft container 230 to upper tank 200 going through return channel 232.
  • a pressure differential typically two to five PSI or 0.13-0.4 Bar, but not restricted to this range
  • probe-shaft container 230 and upper tank 200 to maintain aqueous- ozone flow so high-level disinfection is appropriately accomplished including having flow through the lumens or channels of endoscope connector assembly 245.
  • Orifice seal 255 incorporates an anti-constant-contact device (e.g., FIGS 5E and 5F) so the endoscope-probe shaft 250 can be effectively high-level disinfected in that region of its surface.
  • the walls of probe-shaft container 230 can be convoluted to focus the bubbles to cause some additional turbulence against endo scope-probe shaft 250. While normally the added turbulence would reduce ozone concentration, this does not occur in an exchanger environment where one is mixing gas into liquid such as is true in this case where endoscope-probe shaft 250 is used as a contractor.
  • a key consideration in endoscope reprocessing is to ensure that no part of the endoscope undergoing high-level disinfection is in constant contact with any element holding any part of the endoscope.
  • An example is anti-constant-contact subsystem 260 whose alternate sets of plates move up and down so that endoscope cable 240 is lifted up by one set of plates freeing the previous points in contact with blades or plates to be in unrestricted contact with the aqueous-ozone liquid 205.
  • An alternative embodiment for anti-constant-contact subsystem 260 is a system that pumps aqueous ozone vertically in and out of openings at the bottom of upper tank 205 to lift endoscope parts off the bottom of upper tank 205 and then lower them.
  • Aqueous ozone comes into the reprocessor from the ozone-infusion system through channel 268 and returns aqueous ozone to the ozone- infusion system through channel 270.
  • the concentration of aqueous ozone entering though channel 268 will already be the appropriate value because it comes from the ozone-infusion system that is recirculating (see FIG. 22) and is brought to the correct concentration prior to its aqueous ozone being introduced into the reprocessor.
  • Endoscope-probe shaft250 may contain open ports for flow between aqueous ozone orifice 285 and endoscope connector assembly 245. In this case bubble and water alternating slugs of material will p ass through the passages in 230 to internally disinfect under agitation internal surfaces.
  • Orifice seal 255 creates a back pressure in container 230 causing the pressure differential needed to move the fluid/gas mixture from the distal end of endoscope-probe shaft 250 to the endoscope connector assembly 245 ports and out to aqueous ozone 205.
  • the ozone gas in outgassing from the aqueous ozone originating from aqueous ozone orifice 285 enters and surrounds the distal end of endoscope-probe shaft 250 creating surface agitation while diffusing into the surrounding fluid as it slowly makes its way past orifice seal 255 or though return channel 232 and into tank 200. It is then separated from the bulk fluid mass by density as it rises to the surface 210 and is carried away by destruct channel 295 to the destruct.
  • a sensor measuring the concentration of ozone can be included.
  • an ozone detector can be placed outside the device enclosure to check for ozone escape.
  • Aqueous ozone is introduced into upper tank 200 through orifice 272 and continues through channel 275 that passes though pump 280 on its way to the aqueous ozone orifice 285 below the tip of endoscope probe-shaft 250.
  • aqueous ozone through the lumens or channels of endoscope-probe shaft 250 removes particulate matter and liquid droplets and trapped bubbles in addition to providing high-level disinfection of lumen or channel surfaces.
  • Ozone released from liquid aqueous ozone205 in upper tank 200 is removed, including application of a vacuum, through destruct channel 295 going to the ozone destruct to ensure that operators are not exposed to ozone. Negative pressure is maintained in upper tank 200 to prevent gas leaks in the room.
  • the reprocessor is drained through drain channel 290.
  • the level of aqueous ozone in tank 200 is monitored adjusted using an automated subsystem (not shown).
  • Outgassed ozone from the aqueous ozone will penetrate bubbles as discussed in FIG. 28 and will disinfect surfaces behind the bubbles that would otherwise constitute voids.
  • the vertical orientation creates a pressure differential between the probe-shaft container 230 and tank 200.
  • the configuration creates an ozone contactor/agitator to dislodge any biological-material debris present and float it to tank 200.
  • the design minimizes turbulence causing separation of ozone gas from aqueous ozone.
  • pump 280 is reversed to pump backwards and then reversed again to pump forwards with that cycle repeated per protocol to mobilize microorganisms and other particulate matter from the surfaces of the endoscope.
  • the processed endoscope could be dried with air or gaseous ozone. Drying will preferentially be performed with low-concentration gaseous ozone (1 to 3ppm, but not limited to this range) delivered over a period of two minutes (although not limited to this time) with decreasing concentration at the end of the period such that when the reprocessor is opened the operator is not exposed to any significant concentration of ozone. Note that the pressure that the endoscope is exposed to is low (3 to 5 PSI or 0.13-0.4 Bar) and thus there would be no problem with water intrusion into internal endoscope mechanisms. The highest pressure is at the distal end of endoscope-probe shaft 250.
  • an ancillary aqueous-ozone channel comes off channel 275 and is connected to that additional endoscope port and used to irrigate aqueous ozone in and out of said port for cleaning and disinfection. This is important because such ports are great niduses for biofilm creation.
  • aqueous ozone instead of the aqueous ozone being drained at the end it will be pumped into a transfer-holding reservoir and kept there until the next endoscope is to be reprocessed at which time the aqueous ozone is reintroduced into the reprocessor as opposed to starting afresh.
  • This approach would be implemented, for example, as in FIG. 8A, with its pump 889 and reservoir 891. This approach is appropriate because unlike other methods of disinfection where the disinfectant is reused, there is not the risk of introducing microbe hazards.
  • FIG. 3A shows a plan view of the end of an endoscope 300. Ports may vary but typically will have tool port 305, camera 310, light source 315 and air/water port 320 with dimensions and shapes varying among endoscopes. It is critical to ensure that ozone is in contact with all surfaces that are to be high-level disinfected. This can be called void-elimination where a void would be a surface that is in constant contact with the reprocessing device such that the active agent is never in contact with a part of the endoscope being reprocessed.
  • FIG. 3B illustrates an embodiment of such an anti-constant-contact device; such a device is optional.
  • the distal end of the endoscope is shown that has a terminal end 325.
  • Device 335 grabs the terminal end snout of the endoscope so that aqueous ozone entering from channel 330 is forced up through the lumens such as those illustrated in FIG. 3 A.
  • Channel 330 also has a jet opening 340 that provides aqueous ozone to the outer surface of the endoscope probe shaft.
  • An O-ring, shown in cross sections 345 and 350 is moved up and down over terminal end 325 by actuators 355 and 360 extending and retracting plungers 365 and 370 that are attached to the O-ring cross sections 345 and 350 respectively.
  • the wires attached to and controlling actuators 355 and 360 are not shown.
  • the aqueous ozone will always have been in contact with surface of the terminal end of the endoscope at times during the processing cycle.
  • the bracket holding actuators 375 and 380 in a fixed relationship with each other and the wires attached to and controlling actuators 375 and 360 are not shown.
  • some embodiments of chemical devices include connections to individual ports of the endoscope, sometimes to isolate, disinfect, and monitor flow in individual channels that are not of the anti-constant-contact variety and thus can have problems with non- disinfected areas involving those connections.
  • FIGS. 4A- 4B show two embodiments of anti-constant-contact devices to be used in upper tank 200 of the automated reprocessing device shown in FIG. 2.
  • FIG. 4A covers the alternating pairs of vertical articulating plates 260 of FIG. 2.
  • plates 435 and 455 constitute one pair and plates 460 and 465 constitute the other.
  • Each plate of the pair will alternately lift endoscope cable 445 (representing 240 in FIG. 2 and 827 in FIG. 8) in the aqueous- ozone fluid and free cable 445 (representing 240 in FIG. 2 and 827 in FIG. 8) from the surface of the alternative plate. All the plates articulate through holes in horizontal support plate 440.
  • Each plate is attached to a vertical-articulation bar (example 400) that moves up and down in a position constrained by fixed vertical supports (example 405 and 410) with cam 420 rotating on shaft 425 operating against a spring (example 430).
  • Spring 430 is shown in the compressed state and spring 415 in the extended state in the alternate plate in the pair.
  • Cam 420 in shown in the state where its associated plate is extended and cam 450 is shown in the state where its associated plate is retracted. Circles 470 indicate there are more pairs of such parallel plates.
  • FIG. 4B shows an alternative mechanism the wave trough 480.
  • the cable of the endoscope to be reprocessed 240 including endoscope-connector assembly 245 in FIG. 2 is laid in undulating groove 485 with wave trough rotated by an axle in orifice 490.
  • the parts of the anti-constant-contact device would be fabricated out of ozone-resistant material such as Kynar®.
  • FIGS. 5 A- 5F illustrates an embodiment of anti-constant-contact devices to be used in vertical probe-shaft container section 230 of the automated reprocessing device shown in FIG. 2. This prevents surfaces from being in constant contact with the device thus not be adequately disinfected.
  • the sections in FIGS. 5A, 5B, and 5D are horizontal plan-view cross sections showing a view from above.
  • the section shown in FIG. 5C is a vertical section viewed from the side.
  • FIG. 5A shows endoscope-probe shaft 500 enclosed in probe-shaft container 505 (230 in FIG. 2).
  • indentation 510 is a rib that is vertically oriented going in and out of the page. Such ribs may be straight or spiral.
  • endoscope-probe shaft 500 makes it much less likely that endoscope-probe shaft 500 will be in constant contact with the container wall 505. Such constant contact would prevent the aqueous ozone from performing the required high-level disinfection. This problem is eliminated by rotating the probe- shaft container in the horizontal plane as illustrated in FIG. 5B. Endoscope probe-shaft container 505 is rotated by belt 515 that is moved by pulley 520 that rotates around shaft 525. Another embodiment would use a gear system to rotate endoscope probe-shaft container 505. FIG.
  • FIG. 5C shows an embodiment in which endoscope probe-shaft 530 is enclosed in probe-shaft container 532 where probe-shaft container 532 is alternatively elongated and shortened as illustrated by bidirectional arrow 534, thus preventing constant contact of endoscope-probe shaft 530 with probe-shaft container 532.
  • Convoluted Teflon tubing used in probe-shaft container 532 encasing the endoscope can be used for bubble size control, and complex contact.
  • FIG. 5D shows an embodiment with probe-shaft 557 enclosed in probe-shaft container 562 in which the inner wall is perforated with alternative closed elements 567 and open spaces 585. Aqueous-ozone fluid is pushed in and out of openings 555 by the device pushing fluid in and out of space 538.
  • FIGS. 5D and 5E show anti-contact devices positioned at the junction between the tank (205 in FIG. 2) and the container enclosing the endoscope probe shaft 250 in (FIG. 2).
  • endoscope 557 is separated from anti-constant contact shell 579 by roller balls or inflatable donut 582.
  • an inflatable donut could be incorporated (not shown).
  • such a donut can be inflated or deflated at appropriate times.
  • endoscope 557 is separated from anti-constant contact shell 579 by a bracket with flexible legs 595.
  • endoscope 557 is moved in and out of contact shell by an insertion/retraction/retraction
  • anti-constant-contact shell 579 can be rotated for increased effectiveness by a mechanism such as that shown in FIG. 5B or 5D.
  • the wall of the endoscope-probe- shaft contained (230 in FIG. 2) is vibrated to bounce the endoscope being processed off the container shell 579 if they are in contact.
  • FIG. 6 illustrates a block diagram of the automated reprocessing device controller 600.
  • Device controller 600 exerts control over all functions including temp sensors, heaters, cooler devices, pumps, vacuum system, endoscope manipulators preventing disinfection voids in contact surfaces, and the operator interface panel.
  • Microcontroller 605 (with battery back-up to maintain operational parameters) is shown connected to a set of interfaces, Ozone Generator Interface 610, Ozone-Release Controls Interface 615, Ozone-Concentration Sensor Interface 620, Circulation Pump Interface 625, Thermal Control Subsystem Interface 630, Stirrer Motor Interface 635, Liquid-Level Sensor Interface 640, Water-Input Valve Interface 645, Anti- Constant-Contact-Tank Interface 650, Anti-Constant-Contact-Probe-Shaft-Container Interface 655, Fluid Injection/Retraction Interface 660, Ozone-Destruct- Valve Interface 665, Drain Valve Interface 670, and Display Interface 690.
  • Display Interface 690 is connected to Display 695.
  • FIG. 7 shows a set of pseudo code for operating the automated aqueous-ozone endoscope processor as illustrated in FIG. 2 and related figures.
  • FIG. 8A illustrates an embodiment of the ozone-based automated endoscope
  • Tank 800 is filled with aqueous-ozone liquid 803 with liquid surface 806. Bottom of tank 809 would be a gradual cone shape to catch any debris indicating further investigation of previous cleaning operation is needed. Temperature of the fluid is regulated by thermal subsystem 809. Automated endoscope
  • reprocessor subsystems such as liquid stirrer motor 812 (and associated stirrer blade 815), thermal subsystem 809, and anti-constant-contact subsystem 839 are instructed by channel 842 that provides communications to and from the device controller. Cooling of the bulk mass in tank 800 and in probe-shaft container 818 to 0-25degC (although not restricted to this range) is desirable to maintain disinfection consistency throughout the fluid volume.
  • Endoscope head 824 has connected elements probe-shaft 833 that is inserted though orifice seal 836 into probe-shaft container 818 and cable 827 in tank 800 aqueous-ozone liquid 803 that terminates in endoscope connector assembly 830 that provides interfaces to the endoscope camera, light source, vacuum, air source, electrical-interface, and any other on existence or subsequently developed.
  • Orifice seal 836 incorporates a fluid-flow restriction (in the range of 10% to 90% but typically 70% of fluid passing from probe-shaft container 818 to tank 800) with the rest of the fluid passing from probe- shaft container 818 to tank 800 going through channel 821.
  • the walls of probe-shaft container 818 can be convoluted to cause some additional turbulence against endoscope shaft 833.
  • a pressure differential (typically two to five PSI or 0.13-0.4 Bar, but not restricted to this range) is maintained between probe-shaft container 818 and tank 800 to maintain aqueous- ozone flow so high-level disinfection is appropriately accomplished including having flow through the lumens of endoscope connector assembly 830.
  • Orifice 836 incorporates an anti-constant- contact device (e.g., FIGS 5E and 5F) so the endoscope-probe shaft 833 can be effectively high- level disinfected in that region of its surface.
  • a key consideration in endoscope reprocessing is to ensure that no part of the endoscope undergoing high-level disinfection is in constant contact with any element holding any part of the endoscope.
  • anti-constant-contact subsystem whose alternate sets of plates move up and down so that endoscope cable 827 is lifted up by one set of plates freeing the previous points in contact with blades to be in unrestricted contact with the aqueous-ozone fluid.
  • An alternative embodiment for anti-constant-contact subsystem 839 is a system that pumps aqueous ozone vertically in and out of openings at the bottom of tank 800 to gently lift endoscope parts off the bottom of tank 800 and then lower them.
  • Gaseous ozone enters through channel 848 from the ozone-infusion system.
  • Water enters through channel 854 and is pumped through fluid pump 851. The system parameters are set in the controller of FIG.
  • Endoscope 833 may contain open ports for flow between gaseous ozone 863 and endoscope connector assembly 830.
  • Orifice 836 creates a back pressure in cavity 818 causing the pressure differential needed to move the fluid/gas mixture from the distal end to the endoscope connector assembly 830 ports and out to aqueous ozone 803.
  • the ozone gas from channel 848 and outgassing from the aqueous ozone originating from gaseous ozone channel 863 enters and surrounds the distal end of 833 creating surface agitation while diffusing into the surrounding fluid as it slowly makes its way past 836 or though channel 821 and into tank 800.
  • a sensor measuring the concentration of ozone can be included.
  • an ozone detector can be placed outside the device enclosure to check for ozone escape. Gaseous ozone is introduced into tank 800 through gaseous-ozone input channel 857 with orifice 860 and continues through channel 863 that passes to orifice 866 below the tip of endoscope probe-shaft 869.
  • Aqueous ozone recreated by the absorption of gaseous ozone emanating from orifice 860 and orifice 866 is circulated by fluid pump 851 through fluid-circulation channel 845 that exits at channel termination 871 delivering aqueous ozone to the bottom of probe- shaft container 818.
  • an additional endoscope port such as a cleaning port for an elevator control channel, that is not sealed or poorly sealed
  • an ancillary aqueous-ozone channel comes off channel 845 and is connected to that additional endoscope port and used to irrigate aqueous ozone in and out of said port for cleaning and disinfection.
  • a gaseous-ozone channel comes off channel 863 and is connected to that additional port to supply gaseous ozone for cleaning and disinfection.
  • the elevator mechanism at the termination 869 of probe shaft 833 is disinfected by the aqueous ozone in the filling and draining steps and gaseous ozone during the gaseous ozone step as seen in the table of FIG. 29.
  • gaseous ozone will enter a poorly sealed elevator control channel from the elevator mechanism at the terminal end 869 of endoscope probe 833 and provide disinfection.
  • the reprocessor shown in FIG. 8A runs in cycles. Once the reprocessor is initially filled, water ozonated to produce aqueous ozone, the fluid in probe-shaft container 818 and tank 800 is transferred from probe-shaft container 818 to transfer-holding reservoir 891. Fluid from tank 800 will pass through anti-constant-contact device 839 and channel 821 to get to orifice 887 for removal. The transfer is accomplished by pump 889 drawing aqueous ozone input orifice 887 through channel 888 and pushing the fluid out through channel 890 into transfer-holding reservoir 891 with its fluid level 892.
  • Ozonation of fluid in transfer-holding reservoir 891 is continued receiving gaseous ozone input provided to the overall reprocessor though input channel 857 with gaseous ozone passing through channel 894 and emanating from orifice 893.
  • pump 889 is a positive-displacement pump such as a rolling-diaphragm pump and transfer-holding reservoir 891 is position above tanks 800 and 818 such that when the fluid from transfers-holding reservoir 891 is returned, entering probe-shaft container 818 through orifice 887, that can occur through gravity (although pump 889 could be employed as well).
  • Fluid will be returned to probe-shaft container 818 and tank 800 with fluid passing from probe-shaft container to tank 800 though channel 821, with some passing through anti-constant-contact device 836. Much less will pass through anti-constant-contact device 836 because anti-constant-contact device 836 acts as a one-way valve with tank 800 to probe-shaft container 818 being the preferred direction.
  • the pressure in the system is maintained (but not limited to) in a range of about 0.1 to 0.4 atmospheres or 0.1- 0.4 Bar above one atmosphere (1.0 Bar) as provided in ozone-gas input channel 857.
  • the maintenance of a slight positive pressure above one atmosphere or 1.0 Bar ambient pressure decreases evaporation from the thin film.
  • the water level 896 also helps saturate the dry ozone gas further reducing evaporation while gaseous ozone introduced via orifice 866 at 10 to 20 ppm (but not limited to this range) hits the aqueous ozone, brings the thin film to saturation with oxygen if that has not already occurred and proceeds to saturate the aqueous thin film with ozone, driving the dissolved ozone level to a very high level for effective killing of microorganisms in a short period of time (e.g., see FIG. 31).
  • the length of time (cycle time) before aqueous ozone is re-introduced into probe-shaft container 818 for the initial cycle is determined by measuring the ozone level in the aqueous zone with a measurement transducer 895 (located at the input to channel 845 passing through aqueous- ozone pump 851).
  • a measurement transducer 895 located at the input to channel 845 passing through aqueous- ozone pump 851.
  • two ozone-measurement sensors are used, on Oxidation- Reduction Potential (ORP) device to measure values to about 2ppm and an electrochemical sensor (e.g., the Hach Orbis here CI 100) to measure higher values.
  • ORP Oxidation- Reduction Potential
  • the ozone level does begin to rise, the end of the initial cycle is signaled and the removal of aqueous ozone and its movement to the transfer-holding reservoir 891 started. Note that if the ozone rises slowly or the point of ozone rise never occurs or is delayed, this indicates an equipment malfunction or that the endoscope being reprocessed has not been properly cleaned prior to being placed into the reprocessor.
  • the pH is monitored during the initial cycle with an other- than-expected pH value indicating chemical, biological or tissue contamination. Depending on the construction of the particular endoscope, the expected pH value will vary. Note that for consideration of either ozone monitoring or pH monitoring during the initial cycle, the reprocessor uses distilled water so small chemical changes will be evident. Profiles would be collected for various endoscopes to determine the expected nominal values and conditions of concern.
  • the lengths of time of subsequent cycles may be fixed and be in range of (but not limited to) five plus/minus two minutes.
  • the cycle length and the number of such cycles will be related to the type of endoscope being reprocessed.
  • a complex endoscope such as a duodenoscope will have more and longer cycles than a simple endoscope.
  • a duodenoscope may have an initial cycle of seven minutes followed by two cycles of four minutes each in length that would combine with a start-up/endoscope-load time of five minutes and a drain/endoscope-unload time of three minutes for a total reprocessing time of 23 minutes.
  • the fluid is not drained through channel 899, but instead the aqueous fluid is transferred to the Transfer-Holding Reservoir with withdrawal through orifice 887.
  • gaseous ozonation of Transfer- Holding Reservoir 891 continues until the next endoscope is to be processed, at which time, instead of starting the process from scratch, thus taking time for the initialization ozonation, the process starts with already prepared aqueous ozone by releasing the contents of Transfer- Holding Reservoir 891 though orifice 887 such that probe- shaft container 818 and tank 800 are filled with aqueous ozone.
  • the length of the first cycle indicates the level of contamination of the endoscope being processed and can be used to instruct reprocessing personnel as to how effective the pre- high-level disinfection cleaning steps are so those processes can be made more effective.
  • that information can be used to rate the ease of cleaning and high-level disinfection is for a given endoscope type.
  • the system includes the abilities to detect unusual anomalies outside of the norm using built-in run charting of endoscope cycles with the capability to detect poor cleanings in previous steps by plotted data limits for acceptable high and low ozone demand numbers and anything else outside of the norms. For example, this approach could catch excess tissue on elevators, poor rinsing operation, and chemical transfer to sterilization process.
  • aqueous ozone in addition to gaseous ozone, instead of generating aqueous ozone as described here, aqueous ozone would also be delivered to the automated endoscope preprocessor from aqueous-ozone recirculation systems shown in FIG. 22 and as used in FIG. 2.
  • aqueous ozone through the lumens of endoscope 833 removes particulate matter and liquid droplets and trapped bubbles in addition to providing high-level disinfection of lumen surfaces.
  • Ozone released from liquid 803 in tank 800 is removed, including application of a vacuum, through channel 897 going to the ozone destruct to ensure that operators are not exposed to ozone.
  • Channel 897 is located at the other end of tank 800 from probe-shaft container 818 so ozone molecules are definitely drawn over the parts of endoscope that are contained within tank 800 prior to the ozone-gas molecules exit tank 800 through channel 897. Negative pressure is maintained in tank 800 to prevent gas leaks in the room.
  • the reprocessor is drained through channel 899.
  • Ozone gas from channel 848 plus outgassed ozone from the aqueous ozone will penetrate bubbles as discussed in FIG. 28 and will disinfect surfaces behind the bubbles that would otherwise constitute voids.
  • the automated endoscope reprocessing devices of types such as shown in FIGS. 2 and 8 A can have ultrasound-induced vibrations in the tank 200 or 800 respectively contained and the container for the endoscope probe shaft 230 or 833 respectively to aid in mixing the solutions and dislodging debris, but only during start-up as if done during disinfection it could decrease the ozone concentration.
  • the vertical orientation creates a pressure differential between the endoscope probe-shaft container 818 and tank 800.
  • the system also creates an ozone contactor/agitator to dislodge any biological-material debris present and float it to the tank 800.
  • there will be more than one high-level disinfection system e.g., two equivalent units instead of one.
  • the processed endoscope could be dried with air or gaseous ozone ⁇ Gaseous ozone is preferred to prevent any intrusion of airborne infectious agents from being introduced into the high-level disinfection area.
  • Embodiments of the type of FIGS. 2 and 8 A incorporate a rich environment of the mixture of aqueous and gaseous ozone to facilitate high-level disinfection. Note that the pressure that the endoscope is exposed to is low (3 to 5 PSI or 0.13-0.4 Bar) and thus there would be no problem with water intrusion into internal endoscope mechanisms. The highest pressure is at the distal end of endoscope 833.
  • FIG. 8B shows the detail of the control of aqueous and gaseous ozone through the internal channels of the endoscope and the region of FIG. 8 A for which this is the detail is marked.
  • FIG. 8B is representative only; the invention is applicable to a myriad of numbers of channels as well as types of valve and port locations and orientations.
  • Shaft 872 terminated in distal- endoscope termination 869 through which aqueous and gaseous ozone moving typically through three channels.
  • One of those channels is suction channel 876 with side biopsy port 877 through valve-cavity 874 and continuing through channel 879, with the potential to terminate in manifold 885 as connection ports.
  • valve assemblies for valve cavities 874 and 880 will have been removed from the endoscope during preparation for reprocessing and placed in tank 800 for high- level disinfection. They can be placed in a roller mechanism (not shown) so they will not be subject to constant contact but will also allow fluid exchange through internal passages in the 875, 878, 881.
  • valve-cavities 874 and 880 as well as the orifice of side biopsy port 876 can be closed in a designated sequence so the aqueous and gaseous ozone can travel through the entire (longest) path for each channel.
  • a trumpet like valve in a trumpet musical instrument, provides for closure of openings of various sizes in series or parallel combinations.
  • a trumpet mechanism incorporates and provides for the required combinatory valving to cover or uncover open valve cavities or ports. Orifice closure is accomplished by blocking the orifice for biopsy port 877 by trumpet 878, blocking valve-cavity 874 with trumpet 875, and valve-cavity 880 with trumpet 1681.
  • valve cavities 878, 875, and 1681 While only two valve cavities are shown in FIG. 16B some embodiments will include more or perhaps only one depending on the configuration of an individual endoscope.
  • the actuators for trumpets 878, 875, and 1681 and their holding mechanisms are not shown. Holding mechanisms are constructed so they provide for anti-constant-contact using techniques such as those illustrated in FIG. 4A or alternating jets of fluid emanating from the walls of the holders and would be unique, as appropriate, for each individual or families of endoscopes.
  • One approach is to have an adjustable holder that uses a profilometer mechanism allowing the AER operator to shape the holder to the given endoscope and lock the profile in place for future use.
  • One embodiment would use a low-temperature alloy metal (with a melting temperature below lOOdegC) in a flexible barrier to fix shape of the endoscope element holder or to drive a profilometer. In some cases, an anti-constant contact mechanism would be included in the fixture shape.
  • channels 879, 883, and 884 can be discharged into upper tank 800 or channeled by manifold 885 with its input channels 886 and output channel 898 that plugs into the input to ozone sensor 895.
  • a valve (not shown) that would allow input to ozone sensor 895 to be the only input from manifold 885 or allow input from both manifold 885 and aqueous ozone 803 in tank 800.
  • the system can monitor the ozone level and detect the length of time until ozone breakthrough occurs. If the time is long it indicates that ozone has been consumed by residual tissue contamination or chemical
  • a pH sensor is collocated with ozone sensor 895 and changes in H level can also indicate contamination.
  • valves could be activated in turn to allow only the output of one of channels 879, 883, and 884 to be delivered to ozone sensor 895 through manifold 885 and so contamination, if present, can be isolated to one or more individual channels.
  • Endoscopes can have internal cross connections in which removing of a valve will expose two or potentially more channels, like an air channel and a water channel.
  • channels 879, 883, and 884 are plugged into manifold 885, the output port 898 is closed by a trumpet mechanism to allow isolation of individual channels.
  • trumpet mechanism or trumpet mechanisms to close one or more channels 879, 883, and 884 could be applied as appropriate to allow isolation of individual channels.
  • FIG. 9 illustrates a block diagram of the gaseous-ozone-based automated reprocessing device controller 900.
  • Device controller 900 exerts control over all functions including temp sensors, heaters, cooler devices, pumps, vacuum system, endoscope manipulators preventing disinfection voids in contact surfaces, and the operator interface panel.
  • Microcontroller 905 (with battery back-up to maintain operational parameters) is shown connected a set of interfaces, Ozone Generator Interface 910, Ozone-Release Controls Interface 915, Ozone- Concentration Sensor Interface 920, Gaseous-Ozone Pressure Control 923, Fluid and Transfer- Holding Reservoir Pump Interface 925, Thermal Control Subsystem Interface 930, Stirrer Motor Interface 935, Liquid-Level Sensor Interface for tank 940, Water-Input Valve Interface 945, Anti- Constant-Contact-Tank Interface 950, Anti-Constant-Contact-Probe-Shaft-Container Interface 955, Fluid Injection/Retraction Interface 960, Liquid-Level Sensor Interface for Transfer-Holding Reservoir 965 Ozone-Destruct- Valve Interface 970, Drain Valve Interface 975, and Display Interface 990. Display Interface 990 is connected to Display 995.
  • Ozone-Release Controls Interface 915 Ozone- Concentration Sensor Interface 920
  • Gaseous-Ozone Pressure Control 923 Gaseous-
  • FIG. 10 shows a set of pseudo code for operating the automated aqueous-ozone endoscope processor as illustrated in FIG. 8A and related figures.
  • FIG. 11 illustrates an embodiment of a manual reprocessor based on aqueous ozone.
  • Glove-box enclosure 1100 has two gloves 1105 penetrating its front surface. Gloves 1105 need to be made from silicone or other appropriate material that will not be damaged by contact with ozone.
  • the floor 1110 of the processor sits on base 1115.
  • Endoscope-being-processed 1120 rests on floor 1110 and is comprised of endoscope head 1125, cable segment 1130, endoscope- connector assembly 1135, probe shaft 1140, and probe-shaft tip 1145. Endoscope-being-processed 1120 is submersed in aqueous-ozone bath 1150 with liquid surface 1155.
  • the channel to/from the controller 1160 enters base 1115 while the channels 1165 from the aqueous-ozone generator and 1170 from the ozone generator go directly through the sidewall of enclosure 1100.
  • Channel 1170 releases aqueous ozone into bath 1150 through orifice 1175 and proceeds onto anti-constant- contact device 1180 grabbing the terminal-end snout of the endoscope 1145.
  • the details of component 880 are shown in FIG. 3B.
  • the electrical connection from the device controller 1160 is not shown.
  • Thermal subsystem 1185 regulates the temperature of aqueous-ozone bath 1150.
  • a sensor measuring the concentration of ozone can be included.
  • an ozone detector can be placed outside the device enclosure to check for ozone escape.
  • the optional pump for recirculating fluid in the bath (not shown), if used, is in base 1115.
  • a stirring motor and blade such as shown in FIG. 2 elements 220 and 225 may be included in an alternative embodiment.
  • Gaseous ozone released from aqueous-ozone bath 1150 is removed via channel 1190 to the ozone destruct. Negative pressure is maintained in enclosure 1100 via channel 1190 to prevent gas leaks in the room.
  • the processed endoscope could be dried with air or gaseous ozone. (1 to 3ppm, but not limited to this range) preferentially be performed low-concentration gaseous ozone delivered over a period of two minutes (although not limited to this time) with decreasing concentration at the end of the period such that when the reprocessor is opened the operator is not exposed to any significant
  • an ancillary aqueous-ozone channel comes off channel 1170 (or to the recirculating pump, not shown, in base 1115) and is connected to that additional endoscope port and used to irrigate aqueous ozone in and out of said port for cleaning and disinfection.
  • FIG. 12 illustrates a block diagram of the manual-reprocessing device controller 1200.
  • Microcontroller e.g., Raspberry Pi
  • 1205 (with battery back-up to maintain operational parameters) is shown connected a set of interfaces, Ozone Generator Interface 1210, Ozone- Release Controls Interface 1215, Ozone-Concentration Sensor Interface 1220, Thermal Control Subsystem Interface 1225, Liquid-Level Sensor Interface 1230, Water-Input Valve Interface 1235, Anti-Constant-Contact Device Interface 1240, Ozone-Destruct- Valve Interface 1245, Drain Valve Interface 1250, and Display Interface 1290.
  • Display Interface 1290 is connected to Display 1295.
  • FIG. 13 shows a set of pseudo code for operating the manual aqueous-ozone endoscope processor as illustrated in FIG. 11 and related figures.
  • FIG. 14 shows a block diagram of the ozone-based instrument and appliance reprocessing System. At this level, the diagram is applicable to either an automated or manual system.
  • the reprocessing of an instrument or appliance to undergo high-level disinfection is performed in instrument and appliance reprocessor 1400.
  • Controller 1410 performs the overall control of the system. Controller 1410 provides instructions to the ozone generator 1420 that includes the mechanical ozone-coupler connection to instrument and appliance reprocessor 1400 via channel 1405. Controller 1410 provides instructions to instrument and appliance reprocessor 1400 through channel 1415.
  • Ozone generator 1420 with its coupler can have its input as either ambient air or medical-grade oxygen provided by optional oxygen source 1430 that provides oxygen to ozone generator 1420 through channel 1425.
  • Input to the ozone generator is best at minus 20degC dew point or better that allows low nitric oxide production so increased equipment life is facilitated.
  • Optional oxygen source could also be processed air from a swing separator, typically 85% to 95% oxygen.
  • concentration of oxygen going into ozone generator 1420 will be in the range of 20% to 100%.
  • the temperature of the aqueous-ozone fluid in reprocessor 1400 is controlled by thermal subsystem 1440 through channel 1445. Temperature will ideally be maintained between 0 and 25degC, but not restricted to this range.
  • ozone destruct 1450 Gaseous ozone coming off the surface of the liquid in instrument and appliance reprocessor served 1400 is routed through ozone destruct 1450 through channel 1455 that includes a vacuum system to draw off the ozone.
  • the vacuum system will operate at a low l-5mm Hg.
  • Ozone destruct 1450 ensures that operators are not exposed to gaseous ozone during instrument and appliance reprocessing.
  • Ozone destruct 1450 will normally be constructed using metal oxides to prevent CO production.
  • drain subsystem 1460 that includes a pump and is connected to instrument and appliance reprocessor 1400 by channel 1465. At that point the only residual elements are oxygen and water so the liquid can be safely disposed of through a conventional drain system.
  • any residual ozone is likely to be at low concentration. The value can be measured to see if it might be of some concern in a particular wastewater situation. If a facility wants to make sure that there is definitely no ozone being disposed of, the waste stream can be heated to 40°C, be treated with ultraviolet light, or be treated with an ozone-consuming substance.
  • FIGS. 15 A- 15B illustrates embodiments of the ozone-based automated instrument and appliance reprocessor using aqueous ozone as the high-level disinfection agent.
  • FIG. 15A shows a version where anti-constant contact is implemented as alternating sets of plates within vertical pairs.
  • Tank 1500 is filled with aqueous-ozone liquid 1505 with liquid surface 1510.
  • Bottom of tank 1500 has a gradual cone shape (shown above drain 1599) to catch any debris indicating further investigation of previous cleaning operation is needed.
  • Temperature of the fluid is regulated by thermal subsystem 1515 to 0-25degC (but not restricted to this range).
  • Automated instrument and appliance reprocessor subsystems such as liquid stirrer motorl520 (and associated stirrer blade 1525), thermal subsystem 1515, and anti-constant-contact subsystem 1560 are instructed by channel 1565 that provides communications to and from the device controller.
  • aqueous ozone 1505 in tank 1500 Cooling of the bulk mass of aqueous ozone 1505 in tank 1500 to 0 to 25degC (although not restricted to this range) is desirable to maintain disinfection consistency.
  • a key consideration in instrument and appliance reprocessing is to ensure that no part of the items undergoing high-level disinfection is in constant contact with any element holding or supporting any part of the item.
  • anti-constant-contact subsystem 1560 has pairs of vertical whose members alternatively move up and down so that instruments and appliances 1540 (just arbitrary
  • An alternative embodiment for anti-constant-contact subsystem 1560 is a system that pumps aqueous ozone vertically in and out of openings at the bottom of tank 1500 containing aqueous ozone 1505 to lift instruments and appliances off the bottom of tank 1500 and then lower them.
  • Aqueous ozone comes into the reprocessor from the ozone-infusion system through channel 1568 and returns aqueous ozone to the ozone-infusion system through channel 1570.
  • the concentration of aqueous ozone entering though channel 1568 will already be the appropriate value because it comes from the ozone- infusion system that is recirculating (see FIG. 24) and is brought to the correct concentration prior to its aqueous ozone being introduced into the reprocessor.
  • Gaseous ozone is separated from the bulk fluid mass by density as it rises to the surface 1510 and is carried away by channel 1590 to the destruct.
  • a sensor measuring the concentration of ozone can be included.
  • an ozone detector can be placed outside the device enclosure to check for ozone escape.
  • Aqueous ozone is introduced into tank 1500 through orifice 1572.
  • Ozone released from aqueous ozone liquid 1505 in tank 1500 is removed, including application of a vacuum, through channel 1590 going to the ozone destruct to ensure that operators are not exposed to ozone. Negative pressure is maintained in tank 1500 to prevent gas leaks in the room.
  • the reprocessor is drained through channel 1599.
  • the level of aqueous ozone in tank 1500 is monitored adjusted using an automated subsystem (not shown). Outgassed ozone from the aqueous ozone will penetrate bubbles as discussed in FIG. 28 and will disinfect surfaces behind the bubbles that would otherwise constitute voids.
  • there will be more than one high-level disinfection system e.g., two equivalent units instead of one).
  • the instruments and appliances could be dried with air or gaseous ozone.
  • FIG. 15B shows a version where anti-constant contact 1560 is implemented as a rotating cage wheel that carries instruments and appliances up to the point where they fall off supports and drop through the aqueous ozone.
  • Tank 1500 is filled with aqueous-ozone liquid 1505 with liquid surface 1510.
  • Bottom of tank 1500 has a gradual cone shape (shown above drain 1599) to catch any debris indicating further investigation of previous cleaning operation is needed.
  • Temperature of the fluid is regulated by thermal subsystem 1515 to 0-25degC (but not restricted to this range).
  • Automated instrument and appliance reprocessor subsystems such as liquid stirrer motor 1520 (and associated stirrer blade 1525), thermal subsystem 1515, and anti-constant-contact (cage wheel 1575 rotating on axle 1577 turned by a motor (not shown)) are instructed by channel 1565 that provides communications to and from the device controller. Cooling of the bulk mass of aqueous-ozone liquid 1500 in tank 1500 to 5 to lOdegC (although not restricted to this range) is desirable to maintain disinfection consistency.
  • a key consideration in instrument and appliance reprocessing is to ensure that no part of the items undergoing high-level disinfection is in constant contact with any element holding or supporting any part of the item.
  • An example mechanism for preventing constant contact is anti-constant-contact subsystem using rotating-cage- wheel approach.
  • the anti-constant-contact subsystem is comprised of cage wheel 1575, supported and rotated on a pair of rollers 1577 turned by motors (not shown). As cage wheel 1575 turns clockwise as viewed in the figure, instruments and appliances 1584 (just arbitrary representation here) are lifted up by internal cage-wheel projections 1580.
  • instruments and appliances 1584 When instruments and appliances 1584 are lifted to the point where they are no longer supported by internal cage-wheel projections 1580, they fall off and drop through the aqueous ozone 1505 as falling instrument and appliance parts 1586 (just arbitrary representation here). While falling, instrument and appliance parts 1586 are completely freed from contact with anything that is not aqueous ozone so appropriate high-level disinfection will occur. In addition, as the instruments or appliances fall, they hit and bounce off deflector 1588 so they will not be oriented into the exact same position on the cage wheel that they had in the previous wheel rotation. This feature also provides additional surface turbulence to free any unwanted particulates that may be present.
  • Aqueous ozone comes into the reprocessor from the ozone-infusion system through channel 1568 and returns aqueous ozone to the ozone-infusion system through channel 1570.
  • concentration of aqueous ozone entering though channel 1568 will already be the appropriate value because it comes from the ozone-infusion system that is recirculating (see FIG. 24) and is brought to the correct concentration prior to its aqueous ozone being introduced into the reprocessor.
  • Gaseous ozone is separated from the bulk fluid mass by density as it rises to the surface 1510 and is carried away by channel 1595 to the destruct.
  • a sensor measuring the concentration of ozone can be included.
  • an ozone detector can be placed outside the device enclosure to check for ozone escape.
  • Aqueous ozone is introduced into tank 1500 through orifice 1572. Ozone released from aqueous ozone 1505 in tank 1500 is removed, including application of a vacuum, through channel 1590 going to the ozone destruct to ensure that operators are not exposed to ozone. Negative pressure is maintained in tank 1500 to prevent gas leaks in the room.
  • the reprocessor is drained through channel 1599.
  • aqueous ozone 1505 in tank 1500 is monitored adjusted using an automated subsystem (not shown). Outgassed ozone from the aqueous ozone will penetrate bubbles as discussed in FIG. 28 and will disinfect surfaces behind the bubbles that would otherwise constitute voids.
  • the overall design of the embodiments minimalizes turbulence causing separation of ozone gas from aqueous ozone.
  • there will be more than one high-level disinfection system e.g., two equivalent units instead of one).
  • the processed instruments and appliances could be dried with air or gaseous ozone. When loading the reprocessor, attention is to be paid to the orientation of the instruments and appliances being processed so that ozone will be have access to all surfaces and aqueous and gaseous ozone will not be trapped within features of the items being reprocessed.
  • aqueous ozone instead of the aqueous ozone being drained at the end it will be pumped into a transfer-holding reservoir and kept there until the next set of instruments and/or appliances is to be reprocessed at which time the aqueous ozone is reintroduced into the reprocessor as opposed to starting afresh.
  • This approach is shown in FIGS. 15A and 15B with outflow from the tank channel 1591 feeding pump 1592 without its outflow channel 1593 feeding tank 1594 with fluid level 1596 with aqueous ozone maintained by bubbling gaseous ozone from orifice 1597 that is fed by channel 1598 from the ozone generator (not shown here but connected to channel 2443 in FIG. 24).
  • pump 1592 will be a positive-displacement pump.
  • tank 1500 is to be refilled with aqueous ozone, this operation is performed entirely by gravity by by-passing pump 1592 or can be accomplished by reversing the pump. This approach is appropriate because unlike other methods of disinfection where the disinfectant is reused, there is not the risk of introducing microbial hazards.
  • the reprocessors shown in FIGS. 15A and 15B run in cycles in which gaseous ozone is also involved. Once the reprocessing tanks 1500 have been filled and their contents have been submerged on the order of 95 percent of the aqueous ozone is transferred as above to reservoir holding tank 1594. The removal of the aqueous ozone from tank 1500 leaves a thin film of aqueous ozone on the surfaces of the instrument and appliances undergoing
  • the fluid level of the aqueous ozone 1511 is maintained below the supports under the instruments and appliances and gaseous ozone is passed in from channel 1598 (fed from channel 2443 in FIG. 24) through multiple orifices (including optionally spargers) 1596 so the gaseous ozone is humidified prior to its contacting the thin film of aqueous ozone on the surfaces of the instruments and appliances being processed.
  • the pressure in the system is maintained (but not limited to) in a range of 0.1 to 0.4 atmospheres (0.1-0.4 Bar) above one atmosphere as provided in ozone-gas input channel 1596. The maintenance of a slight positive pressure above one atmosphere ambient pressure decreases evaporation from the thin film.
  • Maintaining the water level at the bottom of the tanks also helps saturate the dry ozone gas further reducing evaporation while gaseous ozone introduced via orifice 1596 at 10 to 20 ppm (but not limited to this range) hits the aqueous ozone, brings the thin film to saturation with oxygen if that has not already occurred and proceeds to saturate the aqueous thin film with ozone, driving the dissolved ozone level to a very high level for effective killing of microorganisms in a short period of time (e.g., see FIG. 31).
  • the length of time (cycle time) before aqueous ozone is re-introduced to tank 1500 for the initial cycle is determined by measuring the ozone level in the aqueous zone with a
  • two ozone-measurement sensors are used, on Oxidation-Reduction Potential (ORP) device to measure values to about 2 ppm and an electrochemical sensor (e.g., the Hach Orbisphere CI 100) to measure higher values.
  • ORP Oxidation-Reduction Potential
  • electrochemical sensor e.g., the Hach Orbisphere CI 100
  • the end of the initial cycle is signaled and the removal of aqueous ozone and its movement to the transfer-holding reservoir 1594 started.
  • the pH is monitored during the initial cycle with an other-than-expected pH value indicating chemical, biological or tissue contamination.
  • the expected pH value will vary. Note that for consideration of either ozone monitoring or pH monitoring during the initial cycle, the reprocessor uses distilled water so small chemical changes will be evident. Profiles would be collected for various instruments and/or appliances to determine the expected nominal values and conditions of concern.
  • the lengths of time of subsequent cycles may be fixed and be in a range of (but not limited to) five plus/minus two minutes.
  • the cycle length and the number of such cycles will be related to the types of instruments and appliances being reprocessed.
  • a complex instrument may have an initial cycle of seven minutes followed by two cycles of four minutes each in length that would combine with a start-up/instrument and/or appliance-load time of five minutes and a drain/instrument-and/or-appliances-unload time of three minutes for a total reprocessing time of 23 minutes.
  • the fluid is not drained through channel 1599, but instead the aqueous fluid is transferred to the Transfer-Holding Reservoir 1594 with withdrawal through orifice 1591.
  • gaseous ozonation of Transfer- Holding Reservoir 1594 continues until the next batch to be reprocessed, at which time, instead of starting the process from scratch, thus taking time for the initialization ozonation, the process starts with already prepared aqueous ozone by releasing the contents of Transfer-Holding Reservoir 1594 though channel 1591 such that tank 1500 is filled with aqueous ozone.
  • the length of the first cycle indicates the level of contamination of the instruments and/or appliances being reprocessed and can be used to instruct reprocessing personnel as to how effective the pre-high-level disinfection cleaning steps are so those processes can be made more effective.
  • that information can be used to rate the ease of cleaning and high-level disinfection is for a given instrument and/or appliance type.
  • the system includes the abilities to detect unusual anomalies outside of the norm using built-in run charting of reprocessing cycles with the capability to detect poor cleanings in previous steps by plotted data limits for acceptable high and low ozone demand numbers and anything else outside of the norms. For example, this approach could catch excess tissue on instrument projection, poor rinsing operation, and chemical transfer to the disinfection process.
  • Ozone released from liquid in tank 1500 is removed, including application of a vacuum, through channel 1590 going to the ozone destruct to ensure that operators are not exposed to ozone. Negative pressure is maintained in tank 1505 to prevent gas leaks in the room.
  • the reprocessor is drained through channel 1599. Ozone gas from channel 1596 plus outgassed ozone from the aqueous ozone will penetrate bubbles as discussed in FIG. 28 and will disinfect surfaces behind the bubbles that would otherwise constitute voids.
  • the automated reprocessing devices of types such as shown in FIGS.
  • FIGS. 15A and 15B can have ultrasound-induced vibrations in the tank 1500 to aid in mixing the solutions and dislodging debris, but only during start-up as if done during disinfection it could decrease the ozone concentration.
  • the processed medical and dental instruments and appliances would be dried with air or gaseous ozone ⁇ Gaseous ozone is preferred to prevent any intrusion of airborne infectious agents from being introduced into the high-level disinfection area. (1 to 3 ppm, but not limited to this range) preferentially be performed low-concentration gaseous ozone delivered over a period of two minutes (although not limited to this time) with decreasing concentration at the end of the period such that when the reprocessor is opened the operator is not exposed to any significant concentration of ozone.
  • Embodiments of the type of FIGS. 15A and 15B incorporate a rich environment of the mixture of aqueous and gaseous ozone to facilitate high- level disinfection.
  • FIG. 16 shows alternative embodiments of an anti-constant-contact device to be used in tank 1500 of the automated reprocessing device shown in FIG. 15.
  • FIG. 16A covers the alternating pairs of vertical articulating plates 1560 of FIG. 15. Plates 1635 and 1646 constitute one pair and plates 1648 and 1650 constitute the other. Each plate of the pair will alternate lifting instruments or appliances 1642 in the aqueous-ozone fluid and free instruments or appliances 1642 from the surface of the alternative plate. All the plates articulate through holes in horizontal support plate 1640.
  • Each plate is attached to a vertical-articulation bar (example 1600) that moves up and down in a position constrained by fixed vertical supports (example 1605 and 1610) with cam 1620 rotating on shaft 1625 operating against a spring (example 1630).
  • Spring 1630 is shown in the compressed state and spring 1615 in the extended state in the alternate plate in the pair.
  • Cam 1620 in shown in the state where its associated plate is extended and cam 1644 is shown in the state where its associated plate is retracted. Circles 1652 indicate there are more pairs of such parallel plates.
  • FIGS. 16B and 16C illustrate an embodiment using a link belt, with FIG. 16B showing a side view and FIG. 16C showing a plan view of the link belt itself.
  • rollers 1658 are rolled back and forth on axles 1660 rotated by a motor (not shown) with both axles 1660 having a synchronized motion by being connected with a linked chain.
  • Rollers 1658 have rods 1662 projecting radially out and engaging open spaces in link belt 1656 (also seen as spaces-between- links 1681 in the plan view of the link belt show in FIG. 16C) to rotate link belt 1656.
  • Buckling of link belt 1656 is implemented by running it though the mechanism created by having rollers 1666, turning on axles 1668, that cross the entire width of link belt 1656 below link belt 1656 elevating link belt 1656 and depressing link belt 1656 by rollers 1670. Because the links are connected by stiff pins, the flexure of the belt occurs at link hinges along the entire width of the belt. This allows a ridge to form along the entire width of the belt 1665. Rollers 1670 are narrower than rollers 1666, and only engage link belt 1656 over two link (1679 in FIG. 3C) distances from the edge on each side.
  • FIG. 16C illustrates link belt 1656 of FIG. 16B in a plan view. Plates 1679 are held together by pins 1683 that pass-through plates 1679 near their ends. The configuration has open spaces 1681 such that projections 1662 of wheel 1658 of FIG. 16B can engage link belt 1656 and effectively move it in either direction.
  • the open spaces 1681 make sure that there is not constant contact with mechanical mechanisms but at times there is free access to aqueous ozone so effective high-level disinfection can occur.
  • the numbers of sets of links across link belt 1656 can in the range of four sets to five-dozen sets, although not restricted to this range. The arbitrary number of such sets is indicated by sets of dots 1685.
  • FIG. 16D shows a non-constant-contact implementation using rollers.
  • the rollers 1690 rotating on axles 1693 driven by motors move clockwise and counter clockwise so that instruments or appliances 1696 move laterally back and forth and do not roll off either end. Stops at either end (not shown) could be included.
  • the rollers are synchronized in rotation; for example, driving rollers 1690 with gears at their ends engaged by a link chain rotated by a motor.
  • FIG. 17 illustrates a block diagram of the automated reprocessing device controller 1700.
  • Device controller 1700 exerts control over all functions including temp sensors, heaters, cooler devices, pumps, vacuum system, instrument and appliance manipulators preventing disinfection voids in contact surfaces, and the operator interface panel.
  • Microcontroller (e.g., Raspberry Pi) 1705 (with battery back-up to maintain operational parameters) is shown connected a set of interfaces, Ozone Generator Interface 1710, Ozone-Release Controls Interface 1715, Ozone-Concentration Sensor Interface 1720, Circulation Pump Interface 1725, Thermal Control Subsystem Interface 1730, Stirrer Motor Interface 1735, Liquid-Level Sensor Interface 1740, Water-Input Valve Interface 1745, Anti-Constant-Contact-Tank Interface 1750, Ozone-Destruct- Valve Interface 1755, Drain Valve Interface 1760, Transfer to and from Transfer-Holding
  • Ozone Generator Interface 1710 Ozone-Release Controls Interface 1715
  • Ozone-Concentration Sensor Interface 1720 Ozone-Concentration Sensor Interface 1720
  • Circulation Pump Interface 1725 Circulation Pump Interface 1725
  • Thermal Control Subsystem Interface 1730 Stirrer Motor Interface 1735
  • Liquid-Level Sensor Interface 1740 Water-Input Valve Interface 1745
  • Display Interface 1790 is connected to Display 1795.
  • FIG. 18 Shows a set of pseudo code for operating the automated aqueous-ozone instrument and appliance reprocessor as illustrated in FIGS. 15A and 15B and related figures.
  • FIG. 19 illustrates an embodiment of a manual reprocessor based on aqueous ozone.
  • Glove-box enclosure 1900 has two gloves 1905 penetrating its front surface. Gloves 1905 need to be made from silicone or other appropriate material that will not be damaged by contact with ozone.
  • the floor 1910 of the reprocessor tank sits on base 1915. Instruments and appliances- being-processed 1965 (just arbitrary representation here) rest on reprocessor-tank floor 1910. Those instruments and appliances are submersed in aqueous-ozone bath 1950 with liquid surface 1955.
  • the channel to/from the controller 1960 enters base 1915 while the channels 1995 to the aqueous-ozone generator and 1970 from the aqueous-ozone generator go directly through the sidewall of enclosure 1900.
  • Channel 1970 releases aqueous ozone into bath 1950 and channel 1995 from the aqueous-ozone generator returns the aqueous ozone for recirculation.
  • the electrical connection from the device controller 1960 is not shown.
  • Thermal subsystem 1985 regulates the temperature of aqueous-ozone bath 1950.
  • a sensor measuring the concentration of ozone can be included.
  • an ozone detector can be placed outside the device enclosure to check for ozone escape.
  • the optional pump for recirculating fluid in the bath (not shown), if used, is in base 1915.
  • a stirring motor and blade such as shown in FIG. 15A elements 1520 and 1525 may be included in an alternative embodiment.
  • Gaseous ozone released from aqueous-ozone bath 1950 is removed via channel 1990 to the ozone destruct. Negative pressure is maintained in enclosure 1900 via channel 1990 to prevent gas leaks in the room.
  • the liquid of aqueous- ozone bath 1950 is drained through drain channel 1996. While the operator is doing the manual reprocessing she or he needs to move the instruments and appliances to avoid constant contact that would preclude effective high-level sterilization.
  • the device incorporates an anti-constant-contact mechanism (not shown) in which aqueous ozone is pumped vertically in and out of openings at the bottom of tank floor 1910 to lift instruments and appliances 1965 (just arbitrary representation here) off the bottom of the high-level disinfection tank.
  • an anti-constant-contact mechanism (not shown) in which aqueous ozone is pumped vertically in and out of openings at the bottom of tank floor 1910 to lift instruments and appliances 1965 (just arbitrary representation here) off the bottom of the high-level disinfection tank.
  • FIG. 20 illustrates a block diagram of the manual-reprocessing device controller 2000.
  • Microcontroller e.g., Raspberry Pi
  • Microcontroller 2005 (with battery back-up to maintain operational parameters) is shown connected a set of interfaces, Ozone Generator Interface 2010, Ozone- Release Controls Interface 2015, Ozone-Concentration Sensor Interface 2020, Thermal Control Subsystem Interface 2025, Liquid-Level Sensor Interface 2030, Water-Input Valve Interface 2035, Anti-Constant-Contact Device Interface 2040, Ozone-Destruct- Valve Interface 2045, Drain Valve Interface 2050, and Display Interface 2090.
  • Display Interface 2090 is connected to Display 2095.
  • FIG. 21 shows a set of pseudo code for operating the manual aqueous-ozone
  • FIG. 22 illustrates an embodiment of a recirculating ozone-infusion system device with its coupling device for efficiently generating aqueous ozone for delivery to the high-level disinfection or sterilization device.
  • Device enclosure 2200 has as its input either an optional oxygen source 2205 with that or ambient air passing through channel 2210 to air dryer 2215. The gas then passes through channel 2220 to pump 2225 (that could be placed at other locations in the circuit) and then through channel 2230 to ozone generator 2235 where through corona discharge or other mechanism ozone gas is generated which passes through outflow channel 2240 through coupler 2245 into bottle 2250 filled with high-quality water (e.g., distilled or reverse osmosis) with liquid surface 2260.
  • high-quality water e.g., distilled or reverse osmosis
  • Sparger 2265 outputs ozone gas bubbles 2270 that become dissolved in liquid 2255 to produce aqueous ozone.
  • the aqueous ozone flows through recirculation output channel 2275 to the automated or manual endoscope-reprocessing device and comes back through recirculation input channel 2280.
  • Recirculation output channel 2275 has pump 2277 and cooler (e.g., Peltier) 2279 inline.
  • Recirculation output channel 2275 connects to input channel 268 in FIG. 2.
  • Recirculation input channel 1280 connects to output channel 270 in FIG. 2.
  • Gas outgassed from bottle 2250 passes via coupler 2245 through return channel 2285 where the gaseous ozone is removed by ozone destruct 2290 with the processed gas leaving channel 2295 and released into ambient air.
  • return channel 2285 there is restriction 2287 to increase and control the pressure of bottle 2250 relative to the input to ozone destruct 2290.
  • the impacts of pump 2277 and restriction 2287 can be balanced by maintaining a constant height of liquid surface 2260. This could be accomplished by having a level sensor (not shown) controlling either pump 2277 or restriction 2287. Since the ozone has been removed, there is no danger to the operators of the reprocessor.
  • FIG. 23 illustrates an embodiment of an ozone-infusion system device with its coupling device for efficiently generating gaseous ozone for delivery to the high-level disinfection device.
  • Device enclosure 2300 has as its input either an optional oxygen source 2303 (with pressure regulator 2306 and optional cooling device 2309) with that or ambient air passing through channel 2312 to air dryer 2315.
  • the gas then passes through return channel 2320 to pump 2325 (that could be placed at other locations in the circuit) and then through channel 2330 to ozone generator 2335 where through corona discharge or other mechanism ozone gas is generated which passes through outflow channel 2340 through coupler 2345 into bottle 2350 where optional sparger 2365 outputs the ozone gas bubbles 2370.
  • While sparger 2365 will diffuse the ozone gas emanating from outflow channel 2340, it is not required.
  • the aqueous ozone flows through output channel 2375 to the automated endoscope-reprocessing device, for example entering at channel 857 in FIG.8A.
  • Gas coming back from bottle 2350 passes via coupler 2345 through return channel 2385 where the gaseous ozone is removed by ozone destruct 2390 with the processed gas leaving channel 2395 and released into ambient air.
  • return channel 2385 there is restriction 2387 to increase and control the pressure of bottle 2350 relative to the input to ozone destruct 2390. Since the ozone has been removed, there is no danger to the operators of the reprocessor.
  • FIG. 24 illustrates an embodiment of a recirculating ozone-infusion system device with its coupling device for efficiently generating aqueous ozone for delivery to the high-level disinfection device.
  • Device enclosure 2400 has as its input either an optional oxygen source 2405 with that or ambient air passing through channel 2410 to air dryer 2415. The gas then passes through channel 2420 to pump 2425 (that could be placed at other locations in the circuit) and then through channel 2430 to ozone generator 2435 where through corona discharge or other mechanism ozone gas is generated which passes through outflow channel 2440 through coupler 2445 into bottle 2450 filled with high-quality water (e.g., distilled or reverse osmosis) with liquid surface 2460.
  • high-quality water e.g., distilled or reverse osmosis
  • output of gaseous ozone passes through channel 2443.
  • Sparger 2465 outputs ozone gas bubbles 2470 that become dissolved in liquid 2455 to produce aqueous ozone.
  • the aqueous ozone flows through recirculation output channel 2475 to the automated or manual instrument and appliance reprocessing device and comes back through recirculation input channel 980.
  • Recirculation output channel 2475 has pump 2477 and cooler (e.g., Peltier) 2479 inline.
  • Recirculation output channel 2475 connects to input channel 1568 in FIG. 15.
  • Recirculation input channel 2480 connects to output channel 1570 in FIG. 15.
  • the ozone gas from channel 2443 connects to input channel 1598 in the reprocessor of FIG. 15.
  • Gas outgassed from bottle 2450 passes via coupler 2445 through return channel 2485 where the gaseous ozone is removed by ozone destruct 2490 with the processed gas leaving channel 995 and released into ambient air.
  • restriction 2487 to increase and control the pressure of bottle 2450 relative to the input to ozone destruct 2490.
  • the impacts of pump 2477 and restriction 2487 can be balanced by maintaining a constant height of liquid surface 2460. This could be accomplished by having a level sensor (not shown) controlling either pump 2477 or restriction 2487. Since the ozone has been removed, there is no danger to the operators of the reprocessor.
  • FIG. 25 shows details of an embodiment of a coupler of the type element 2245 of FIG. 22, 2345 of FIG. 13, and 2445 of FIG. 24. Such couplers are covered in U.S. Patent 9,220,800.
  • FIG. 25 illustrates the coupling mechanism of the coupling of the aqueous-ozone recirculating bottle to the channels to and from the given reprocessor.
  • the connections to the ozone generator such as the ones shown in FIGS. 22, 24 are through cap 2500 with its ozone-feed- barb fitting 2508 output from the ozone generator and fitting 2504 through which undissolved ozone leaves bottle and returns to the generator enclosure.
  • Distribution plate 2512 has its input as tubular extension 2516 and as its output tubular extension 2520 and is plugged into locking collar 2524 with wings 2528 with output tubular extension 2520 passing through locking collar 2524 and ready to receive the bottle assembly 2530.
  • the top of bottle assembly 2530 is lower cap 2532 and output tubular extension 2520 fits into down spout 2536 passing through circumferential flange 2540 with down spout 2536 secured within inner bottle nut cylindrical section 2544 and inner bottle nut cylindrical section 2548 by fitting into collar/groove arrangement 2552.
  • inner bottle nut cylindrical sections 2544 and 2584 have a vertical-grooves feature 2556 and inner surfaces having spiral grooves on inner wall of inner bottle nut 2560 that engage spiral threads 2598 at the top of bottle 2584.
  • Vertical-grooves feature 2556 match the vertical teeth on inner wall 2564 of inner wall of outer bottle nut 2572 top of nut assembly 2568 that is contained within outer bottle nut 2572 with sealing of elements done by O-rings 2576.
  • the ozone gas enters the fluid contained within bottle 2594 through ozone feed tube 2578 with the ozone gas entering the liquid through diffuser/sparger 2580.
  • the output of undissolved gas back to the ozone generator passes through delivery line 2582.
  • Ozone feed tube 2578 and delivery line 2582 can be connected using threads, force-fit, or other suitable attachment means.
  • the diameter of the neck of bottle 2584 can be increased to allow larger channels for ozone feed tube 2578 and delivery line 2582 to permit increased gaseous-zone flow.
  • bottle 2584 is the channel to reprocessor 2588 that includes inline pump 2590 and cooler 2592. It is key that the aqueous ozone is chilled so that more of the ozone gas remains in solution and thus the concentration of aqueous ozone will be increased. At room temperature, the concentration of aqueous ozone might be 2ppm where at 7 degrees Centigrade (45 degrees Fahrenheit) the aqueous-ozone concentration could be 5ppm.
  • the sequence of pump versus cooler or whether the pump and cooler are in channel to reprocessor 2588 or in channel from reprocessor 2594 does not matter. It is also possible that the pump could be in channel to reprocessor 2588 or in channel from reprocessor 2594 or vice versa.
  • the entry of channel from reprocessor 2594 into bottle 2584 is orifice 2596. Channel into reprocessor 2588 connects to input channel 268 in FIG. 2 and channel from reprocessor 2594 connects to output channel 270 in FIG. 2.
  • FIG. 26 illustrates, in assembled form, the coupling mechanism of the coupling of the aqueous-ozone recirculating bottle to the channels to and from the given reprocessor.
  • the connections to the ozone generator such as the ones shown in FIGS. 22, 23, and 24 are through cap 2600 with its ozone-feed-connector-tube fitting 2608 output from the ozone generator and fitting 2604 through which undissolved ozone leaves bottle and returns to the generator enclosure.
  • the ozone generator side of the coupler is comprised of upper section 2626 and lower section 2622 that contains opening 2640.
  • the bottle 2620 side of the coupler is element 2624.
  • Ozone gas enters the fluid contained within bottle 2620 through ozone feed tube 2684 with the ozone gas entering the liquid through diffuser/sparger 2680.
  • the output of undissolved gas back to the ozone generator passes through delivery line 2682.
  • bottle 2620 includes the channel to reprocessor 2688 that includes inline pump 2690 and cooler 2692.
  • the aqueous ozone is chilled so that more of the ozone gas remains in solution and thus the concentration of aqueous ozone will be increased.
  • the concentration of aqueous ozone might be 2ppm where at 7 degrees Centigrade (45 degrees Fahrenheit) the aqueous-ozone concentration could be 5ppm.
  • the sequence of pump versus cooler or whether the pump and cooler are in channel to reprocessor 2688 or in channel from reprocessor 2694 does not matter. It is also possible that the pump could be in channel to reprocessor 2688 or in channel from reprocessor 2694 or vice versa.
  • the exit of channel from reprocessor 2688 from bottle 2620 is orifice 2690.
  • FIG. 27 illustrates, in assembled form, the ozone-generator side of the coupling mechanism of the coupling of the aqueous-ozone recirculating bottle.
  • the connections to the ozone generators such as the ones shown in FIG. 22, 23, and 24 are through cap 2700 with its ozone-feed- barb fitting 2704 output from the ozone generator and fitting 2708 through which undissolved ozone leaves bottle and returns to the generator enclosure.
  • the ozone generator side of the coupler is comprised of upper section 2726 and lower section 2710 that contains inner groove of locking collar 2742.
  • the upper part of the coupler of the bottle assembly, 2532 in FIG. 25, is pushed on tubular extension 2706 with its orifice in such a manner that the extension of 2532 is placed in the opening of lower section 2740 such that action can be accomplished and then twisted clockwise to lock the bottle assembly in place.
  • FIG. 28 shows three cases of bubble inclusions causing voids in surface access.
  • the ability to effectively deal with these is a key innovation in differentiating the endoscope reprocessing embodiments presented versus the reprocessing solutions using fluid chemicals found in the prior art. Having a chemical agent in a chemical fluid that does not diffuse into the inclusion bubble causes voids of contact behind the bubbles that cannot be disinfected in the prior art.
  • FIG. 28A shows the bubble at a straight junction
  • FIG 28B illustrates a bubble at a right-angle junction
  • FIG. 28C shows trapped bubbles present in a gasket/O-ring junction. This problem is inherently present in the complex geometry of the lumens of an endoscope but can occur in other geometries as well.
  • Duodenoscopes contain a hollow channel that allows the injection of contrast dye or the insertion of other instruments to obtain tissue samples for biopsy or treat certain abnormalities. Unlike most other endoscopes, duodenoscopes also have a movable "elevator" mechanism at the tip. The elevator mechanism changes the angle of the accessory exiting the accessory channel, which allows the instrument to perform diagnostic procedures or to treat problems with fluid drainage.
  • FIG. 28 a trapped bubble 2815 is present at the junction of the larger-diameter lumen 2800 and the adjacent smaller-diameter lumen 2805.
  • the direction of fluid or gas flow is indicated by arrow 2810.
  • FIG. 28B a trapped bubble 2845 is present at the junction of lumen 2830 and adjacent lumen 2835 that is at a right angle to it.
  • the direction of fluid or gas flow is indicated by arrow 2840.
  • FIG. 28C illustrates the situation where an O-ring or other gasket is used between tube segments of an endoscope or where valves are screwed into the body of an endoscope.
  • O-ring 2855 is interfacing segments 2850 and 2852.
  • the inner surface of the O-ring is 2860 and the direction of fluid flow is indicated by arrow 2865.
  • Trapped bubbles 2870 can create voids because the areas behind them cannot be accessed by chemical disinfectants due to the void created by such bubbles.
  • an inclusion bubble can occur on the interior surface without there being a change in lumen diameter or sharp change in direction. This is particularly true since the pressurized fluid containing tiny gas bubbles is passed though one of the lumens of the endoscope as a normal element of the therapeutic or diagnostic procedure.
  • FIG. 8A uses a higher level of gaseous ozone flowing through the interior of the endoscope and thus offers even more absorption of gaseous ozone into inclusion bubbles and more effective high-level disinfection of the surfaces behind them.
  • FIG. 29 illustrates a set of steps for reprocessing using a combination of aqueous and gaseous zone.
  • the listed applied set of steps to be applied and perhaps repeated is preceded by a set of preliminary steps if and as to be applied by protocol and succeeded by a set of postprocessing steps (including drying) per protocol.
  • the set of steps that may be repeated are threefold.
  • the reprocessor tank is (or reprocessor tanks are) filled with aqueous ozone, typically with concentrations in the range (but not limited to) 2 to 5ppm. This provides for high-level disinfection, including the infusion of gaseous ozone contained within the aqueous ozone into void bubbles on device surfaces that otherwise would be shielding those surfaces from the high-level disinfection agent.
  • the reprocessor tank is (or reprocessor tanks are) drained of aqueous ozone. This leaves a thin film of aqueous ozone on the surface of the device.
  • the reprocessor tank is (or reprocessor tanks are) filled with gaseous ozone, typically with concentrations in the range (but not limited to) 10 to 20ppm.
  • the gaseous ozone so applied infuses very rapidly into the relatively small volume of the thin film of aqueous ozone (resulting from the second step) with its initial concentration typically in the range (but not limited to) 2 to 5ppm.
  • the concentration of ozone applied to the device wall increases dramatically (including that in void bubbles now that concentration of ozone such bubbles are exposed to is significantly greater) and thus high-level disinfection will occur in a short period of time. Therefore, the Concentration of ozone times the Time applied will be much lower than otherwise and thus have a much lower probability of damaging components of the device being reprocessed.
  • a key question is if the ozone concentration of ozone gas applied is so much greater than that in aqueous ozone, why not just apply gaseous ozone alone. The answer is twofold. First, ozone works more effectively on walls of microorganisms that are wet.
  • certain bacteria have spore forms (and are in a dormant state) in which they are tightly wrapped up. If those bacterial spores are wetted, they open up so the entirety of the bacterial walls are exposed to the given high-level disinfection agent. Thus exposed, the ozone can break up the bacterial walls and destroy the microorganism' s ability to infect. Note that some bacterial spores are immune to application of harsh chemical disinfection agents even when the spores have been wetted and the spores have opened up. As to ozone itself, the agent can work more effectively on wet microorganism walls.
  • High-level disinfection means that all microorganisms are killed except some types of bacterial spores.
  • Sterilization means that all microorganisms are destroyed including all bacterial spores.
  • the specified invention is capable of providing either level of killing in appropriate circumstances.
  • the repetition of cycles is determined in part by how long a aqueous thin film will remain on the material being disinfected.
  • Supplemental humidity can be introduced to the ozone gas to prolong the aqueous thin film for longer times. This can be accomplished using an ozone source generator that has its bottle partially filled with water just covering the sparger introducing humidity into the gaseous ozone prolonging the aqueous thin film condition state. This can be illustrated by FIG. 23 having sparger 2365 partially or completely covered in water but below the output-channel line 2375 line allowing only gas to leave the chamber 2370 through 2375.
  • FIG. 30 shows graphs of considerations related to material compatibility.
  • a concern when reprocessing of medical and dental instruments and appliances, including endoscopes is the compatibility of materials used in such instruments and appliances to ozone.
  • the impact of the application of ozone is related to CT, the (Concentration of Ozone) x (Time Ozone Applied).
  • the chart in FIG. 30A illustrates a general schema for regions of sufficient kill versus too much material damage.
  • Region 3005 shows where the ozone concentration times or exposure? time is insufficient so there is too little microorganism kill.
  • Region 3010 shows the area where the ozone concentration times time is so high that there will be too much material damage to the device being reprocessed.
  • FIG. 30B shows schemes at two different kill levels, Log 5 Kill and Log 6 Kill.
  • Region 3020 shows where the combination of ozone concentration and exposure time is not sufficient to kill all the targeted microorganisms. Material-compatibility concerns necessitate a judgment.
  • An Ideal-for-Kill Level i.e., in this figure Ideal for Log 5 Kill 3025 and Ideal for Log 6 Kill 3050
  • An Ideal-for-Kill Level is bounded by lines ozone concentration versus exposure time for satisfactory high-level disinfection (i.e., 3040 for Log 5 Kill and 3060 for Log 6 Kill) and Acceptable-Damage Criterion Line for Log Kill (i.e., 3030 for Log 5 Kill and 3055 for Log 6 Kill) above the point where the respective lines cross.
  • FIG. 31 illustrates a profile of ozone when a thin film of aqueous ozone is exposed to gaseous ozone.

Landscapes

  • Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Chemical & Material Sciences (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Dentistry (AREA)
  • Robotics (AREA)
  • Mechanical Engineering (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Pulmonology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)
  • Endoscopes (AREA)

Abstract

Selon l'invention, l'utilisation d'instruments, y compris d'endoscopes, et d'appareils lors de pratiques médicales et dentaires est largement répandue. Une désinfection ou une stérilisation à haut niveau inadéquate de ces instruments expose de manière inhérente les patients à des infections, qui conduisent malheureusement parfois à la mort et non seulement à la morbidité. L'invention concerne une approche efficace et innovante de la désinfection à haut niveau d'endoscopes à l'aide d'ozone aqueux et/ou gazeux destiné à un retraitement automatisé ou manuel, qui fournit une désinfection et une stérilisation à haut niveau, y compris derrière des bulles de gaz sur des surfaces d'instrument et d'appareil comprenant des surfaces d'endoscope, qui créent des vides dans la désinfection ou la stérilisation par des liquides ne contenant pas d'ozone et par élimination du biofilm. L'invention présente la capacité de détecter la quantité de matériel biologique et non biologique devant être traitée et de régler son processus en conséquence, ainsi que de détecter des problèmes dans des éléments du cycle général d'utilisation d'un endoscope et de son retraitement. Des versions automatisées fournissent des mécanismes destinés au contact non constant entre les instruments et les appareils subissant une désinfection ou une stérilisation à haut niveau.
PCT/US2018/043793 2017-07-25 2018-07-25 Ozone aqueux et gazeux destiné au retraitement d'endoscopes et d'autres instruments et appareils médicaux et dentaires WO2019023407A1 (fr)

Applications Claiming Priority (12)

Application Number Priority Date Filing Date Title
US201762536950P 2017-07-25 2017-07-25
US62/536,950 2017-07-25
US201762562273P 2017-09-22 2017-09-22
US62/562,273 2017-09-22
US201762591332P 2017-11-28 2017-11-28
US62/591,332 2017-11-28
US201762612528P 2017-12-31 2017-12-31
US62/612,528 2017-12-31
US201862621427P 2018-01-24 2018-01-24
US62/621,427 2018-01-24
US201862625327P 2018-02-01 2018-02-01
US62/625,327 2018-02-01

Publications (1)

Publication Number Publication Date
WO2019023407A1 true WO2019023407A1 (fr) 2019-01-31

Family

ID=65041399

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2018/043793 WO2019023407A1 (fr) 2017-07-25 2018-07-25 Ozone aqueux et gazeux destiné au retraitement d'endoscopes et d'autres instruments et appareils médicaux et dentaires

Country Status (1)

Country Link
WO (1) WO2019023407A1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020167535A1 (fr) * 2019-02-12 2020-08-20 Medivators Inc. Dispositif de désinfection au chlore
CN114392380A (zh) * 2021-12-10 2022-04-26 唐金福 一种医疗用便携式针头快速消毒设备
CN114453334A (zh) * 2022-02-09 2022-05-10 中国人民解放军火箭军特色医学中心 口腔用具清洗消毒装置及方法
WO2023172380A1 (fr) * 2022-03-08 2023-09-14 Ideate Medical, Inc. Appareil de stérilisation et récipient associé

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5443801A (en) * 1990-07-20 1995-08-22 Kew Import/Export Inc. Endoscope cleaner/sterilizer
US20020085950A1 (en) * 1999-04-30 2002-07-04 Simon Robitaille Method and apparatus for ozone sterilization
US20050220665A1 (en) * 2004-04-05 2005-10-06 Ding Lambert L Low temperature sterilization and disinfections method and apparatus for medical apparatus and instruments
US20160008757A1 (en) * 2014-07-08 2016-01-14 Particle Measuring Systems, Inc. Active filtration system for controlling cleanroom environments
CN205549967U (zh) * 2016-03-29 2016-09-07 威格气体纯化科技（苏州）股份有限公司 除臭氧净化柱及手套箱

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5443801A (en) * 1990-07-20 1995-08-22 Kew Import/Export Inc. Endoscope cleaner/sterilizer
US20020085950A1 (en) * 1999-04-30 2002-07-04 Simon Robitaille Method and apparatus for ozone sterilization
US20050220665A1 (en) * 2004-04-05 2005-10-06 Ding Lambert L Low temperature sterilization and disinfections method and apparatus for medical apparatus and instruments
US20160008757A1 (en) * 2014-07-08 2016-01-14 Particle Measuring Systems, Inc. Active filtration system for controlling cleanroom environments
CN205549967U (zh) * 2016-03-29 2016-09-07 威格气体纯化科技（苏州）股份有限公司 除臭氧净化柱及手套箱

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020167535A1 (fr) * 2019-02-12 2020-08-20 Medivators Inc. Dispositif de désinfection au chlore
CN114392380A (zh) * 2021-12-10 2022-04-26 唐金福 一种医疗用便携式针头快速消毒设备
CN114392380B (zh) * 2021-12-10 2023-09-01 哈尔滨圣年生物科技有限公司 一种医疗用便携式针头快速消毒设备
CN114453334A (zh) * 2022-02-09 2022-05-10 中国人民解放军火箭军特色医学中心 口腔用具清洗消毒装置及方法
WO2023172380A1 (fr) * 2022-03-08 2023-09-14 Ideate Medical, Inc. Appareil de stérilisation et récipient associé

Similar Documents

Publication Publication Date Title
WO2019023407A1 (fr) Ozone aqueux et gazeux destiné au retraitement d'endoscopes et d'autres instruments et appareils médicaux et dentaires
KR100656451B1 (ko) 사용필 의료기구류의 세척·멸균처리방법
CA2162697C (fr) Nettoyeur-sterilisateur d'endoscope
US5882589A (en) Sealed endoscope decontamination, disinfection and drying device
EP1945276B1 (fr) Appareil de retraitement
KR20170105576A (ko) 오존처리된 물의 적용에 의한 손 위생처리를 위한 장치, 방법 및 소프트웨어 물건
US20050220665A1 (en) Low temperature sterilization and disinfections method and apparatus for medical apparatus and instruments
US20020159917A1 (en) System and method for cleaning, high level disinfection, or sterilization of medical or dental instruments or devices
US9089880B2 (en) Apparatus and method for reprocessing lumened instruments
US7323149B2 (en) Supplemental ozone treatment for ensuring the sterility of instrument cleaning systems
US20150314021A1 (en) Sterilization method comprising sterilization fluid and ultrasonically gererated cavitation microbubbles
KR20100127082A (ko) 인체용 프로브 세정 장치 및 그에 사용되는 세정 물질 카트리지
TWI284543B (en) Method and apparatus for low temperature sterilization and disinfections
KR20020078528A (ko) 병원 내시경의 살균 소독 세척장치
TW581690B (en) Cleaning and sterilizing treatment of used medical appliance
US20060199751A1 (en) Supplemental ozone treatment methods for difficult cleaning and sterilizing applications

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 18838119

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 18838119

Country of ref document: EP

Kind code of ref document: A1