WO2020050864A1 - Conceptions et procédés de stérilisation pour chambres d'hôpital et salles d'opération - Google Patents

Conceptions et procédés de stérilisation pour chambres d'hôpital et salles d'opération Download PDF

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Publication number
WO2020050864A1
WO2020050864A1 PCT/US2018/050131 US2018050131W WO2020050864A1 WO 2020050864 A1 WO2020050864 A1 WO 2020050864A1 US 2018050131 W US2018050131 W US 2018050131W WO 2020050864 A1 WO2020050864 A1 WO 2020050864A1
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Prior art keywords
air
chamber
computer processor
damper
phase anti
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Application number
PCT/US2018/050131
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English (en)
Inventor
Stanford M. KELLOGG JR.
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SYNERGY MED GLOBAL DESIGN SOLUTIONS, LLC (a Delaware LLC)
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Priority to PCT/US2018/050131 priority Critical patent/WO2020050864A1/fr
Publication of WO2020050864A1 publication Critical patent/WO2020050864A1/fr

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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
    • A61L9/00—Disinfection, sterilisation or deodorisation of air
    • A61L9/16—Disinfection, sterilisation or deodorisation of air using physical phenomena
    • A61L9/18—Radiation
    • A61L9/20—Ultraviolet radiation
    • 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
    • A61L9/00—Disinfection, sterilisation or deodorisation of air
    • A61L9/16—Disinfection, sterilisation or deodorisation of air using physical phenomena
    • A61L9/22—Ionisation
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F24—HEATING; RANGES; VENTILATING
    • F24F—AIR-CONDITIONING; AIR-HUMIDIFICATION; VENTILATION; USE OF AIR CURRENTS FOR SCREENING
    • F24F11/00—Control or safety arrangements
    • F24F11/70—Control systems characterised by their outputs; Constructional details thereof
    • F24F11/72—Control systems characterised by their outputs; Constructional details thereof for controlling the supply of treated air, e.g. its pressure
    • F24F11/74—Control systems characterised by their outputs; Constructional details thereof for controlling the supply of treated air, e.g. its pressure for controlling air flow rate or air velocity
    • F24F11/77—Control systems characterised by their outputs; Constructional details thereof for controlling the supply of treated air, e.g. its pressure for controlling air flow rate or air velocity by controlling the speed of ventilators
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F24—HEATING; RANGES; VENTILATING
    • F24F—AIR-CONDITIONING; AIR-HUMIDIFICATION; VENTILATION; USE OF AIR CURRENTS FOR SCREENING
    • F24F3/00—Air-conditioning systems in which conditioned primary air is supplied from one or more central stations to distributing units in the rooms or spaces where it may receive secondary treatment; Apparatus specially designed for such systems
    • F24F3/12—Air-conditioning systems in which conditioned primary air is supplied from one or more central stations to distributing units in the rooms or spaces where it may receive secondary treatment; Apparatus specially designed for such systems characterised by the treatment of the air otherwise than by heating and cooling
    • F24F3/16—Air-conditioning systems in which conditioned primary air is supplied from one or more central stations to distributing units in the rooms or spaces where it may receive secondary treatment; Apparatus specially designed for such systems characterised by the treatment of the air otherwise than by heating and cooling by purification, e.g. by filtering; by sterilisation; by ozonisation
    • F24F3/167—Clean rooms, i.e. enclosed spaces in which a uniform flow of filtered air is distributed
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F24—HEATING; RANGES; VENTILATING
    • F24F—AIR-CONDITIONING; AIR-HUMIDIFICATION; VENTILATION; USE OF AIR CURRENTS FOR SCREENING
    • F24F8/00—Treatment, e.g. purification, of air supplied to human living or working spaces otherwise than by heating, cooling, humidifying or drying
    • F24F8/20—Treatment, e.g. purification, of air supplied to human living or working spaces otherwise than by heating, cooling, humidifying or drying by sterilisation
    • F24F8/22—Treatment, e.g. purification, of air supplied to human living or working spaces otherwise than by heating, cooling, humidifying or drying by sterilisation using UV light
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F24—HEATING; RANGES; VENTILATING
    • F24F—AIR-CONDITIONING; AIR-HUMIDIFICATION; VENTILATION; USE OF AIR CURRENTS FOR SCREENING
    • F24F8/00—Treatment, e.g. purification, of air supplied to human living or working spaces otherwise than by heating, cooling, humidifying or drying
    • F24F8/20—Treatment, e.g. purification, of air supplied to human living or working spaces otherwise than by heating, cooling, humidifying or drying by sterilisation
    • F24F8/24—Treatment, e.g. purification, of air supplied to human living or working spaces otherwise than by heating, cooling, humidifying or drying by sterilisation using sterilising media
    • 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
    • A61L2202/11—Apparatus for generating biocidal substances, e.g. vaporisers, UV lamps
    • 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
    • A61L2202/25—Rooms in buildings, passenger compartments
    • 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
    • A61L2209/00—Aspects relating to disinfection, sterilisation or deodorisation of air
    • A61L2209/10—Apparatus features
    • A61L2209/11—Apparatus for controlling air treatment
    • A61L2209/111—Sensor means, e.g. motion, brightness, scent, contaminant sensors
    • 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
    • A61L2209/00—Aspects relating to disinfection, sterilisation or deodorisation of air
    • A61L2209/10—Apparatus features
    • A61L2209/16—Connections to a HVAC unit
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F24—HEATING; RANGES; VENTILATING
    • F24F—AIR-CONDITIONING; AIR-HUMIDIFICATION; VENTILATION; USE OF AIR CURRENTS FOR SCREENING
    • F24F2110/00—Control inputs relating to air properties
    • F24F2110/10—Temperature
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F24—HEATING; RANGES; VENTILATING
    • F24F—AIR-CONDITIONING; AIR-HUMIDIFICATION; VENTILATION; USE OF AIR CURRENTS FOR SCREENING
    • F24F2110/00—Control inputs relating to air properties
    • F24F2110/20—Humidity
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F24—HEATING; RANGES; VENTILATING
    • F24F—AIR-CONDITIONING; AIR-HUMIDIFICATION; VENTILATION; USE OF AIR CURRENTS FOR SCREENING
    • F24F2120/00—Control inputs relating to users or occupants
    • F24F2120/10—Occupancy
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/20—Air quality improvement or preservation, e.g. vehicle emission control or emission reduction by using catalytic converters
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02B—CLIMATE CHANGE MITIGATION TECHNOLOGIES RELATED TO BUILDINGS, e.g. HOUSING, HOUSE APPLIANCES OR RELATED END-USER APPLICATIONS
    • Y02B30/00—Energy efficient heating, ventilation or air conditioning [HVAC]
    • Y02B30/70—Efficient control or regulation technologies, e.g. for control of refrigerant flow, motor or heating

Definitions

  • This invention is in the field of improved hospital and operating room designs and sterilization methods. These designs and methods are intended to reduce the microbial burden in these rooms, and thus the risk of Surgical Site Infections (SSI) and Hospital Acquired Infections (HAI).
  • SSI Surgical Site Infections
  • HAI Hospital Acquired Infections
  • microorganisms such as staphylococcus aureus, coagulase-negative staphylococci, enterococcus spp., escherichia coli, pseudomonas aeruginosa, enterobacter spp., klebsiella pneumoniae, Candida spp., and other microbes.
  • microorganisms such as staphylococcus aureus, coagulase-negative staphylococci, enterococcus spp., escherichia coli, pseudomonas aeruginosa, enterobacter spp., klebsiella pneumoniae, Candida spp., and other microbes.
  • These infections result in a high rate of death and morbidity, and as well as a considerable amount of expense, and thus constitute a major medical problem. This problem is compounded because increasingly, these microorganisms are antibiotic resistant.
  • HEP A High- efficiency particulate arrestance
  • UV Ultra violet
  • Bioquell Inc. a UK company with US offices in Horsham Pennsylvania, has been active.
  • Prior art by Bioquell includes Watling (US 7,186,371), Martin (US 7,674,440), and Pomeroy (US 2014/0037496).
  • Other work in the field includes Shannon (US 8,551,399).
  • the invention is based, in part, on the insight that microbes can exist on essentially each and every surface of a hospital or clinic treatment room, including hidden or obstructed services, and that the only way to assure that the microbial burden is consistently reduced is to employ airborne sterilizing agents that can penetrate to all surfaces of the hospital or clinic room.
  • the invention is also based, in part, on the insight that such airborne sterilizing agents are generally harmful to humans, and thus to be able to be used on a frequent basis, systems and methods must be devised to make the operation convenient, simple, safe, and nearly foolproof.
  • the invention is also based, in part, on the insight that even after an effective sterilizing cycle, microbes will again enter a room as soon as the room is opened to the outside, and humans again enter the room.
  • air curtains of sterilized air often best delivered by various types of laminar flow delivery devices.
  • laminar flow delivery devices should ideally be configured in a manner that is compatible with the use of the previously discussed airborne sterilizing agents.
  • the invention may be a device, system, and method of reducing the risk of microbial infections such as Hospital Acquired Infections (HAI).
  • HAI Hospital Acquired Infections
  • This system and method will typically rely upon rooms (chambers) equipped with airborne sterilizing agent generators, suitable occupancy and environmental sensors, control mechanisms, and electronic actuator regulated air control devices so as to allow, with very little operator effort, the same chamber to be both thoroughly treated with airborne sterilizing agents, and afterwards also provide suitable laminar flow sources of sterilized air.
  • the invention may be a hospital or clinic chamber based device, system, and method of reducing a risk of HAI.
  • this will be an automated device, system and method that is controlled by one or more computer processors.
  • This chamber will typically have a supply air (e.g. a damper-controlled outside air) intake that will take outside air and sterilize it (often by using a HEP A filter and/or UV sterilizer), as well as a damper-controlled air return.
  • the chamber will typically distribute this sterilized outside air inside the chamber by using a ceiling mounted structural device (e.g. a load bearing structure, and a laminar air flow system (e.g. laminar array) mounted on the structural device), to blow HEPA filtered and UV sterilized supply air over a defined field in said chamber, thus providing an air curtain that helps protect against airborne microbes.
  • a supply air e.g. a damper-controlled outside air
  • the chamber will typically distribute this sterilized outside air inside the chamber by using a ceiling mounted
  • the ceiling mounted structural device performs multiple purposes, such as supporting the laminar array, providing support for hanging medical equipment, and other functions, typically the HEPA filters used to provide HEPA treated air will reside elsewhere, and the HEPA treated air will flow to the laminar array mounted on the ceiling mounted structural device through one or more air ducts, as is shown in Figures 3-6.
  • the invention will verify that no humans are present in the chamber and then restrict access to the chamber.
  • the invention will then isolate the interior air flow in the chamber from outside air (e.g. the hospital or clinic’s main air supply) by closing at least one air return damper and at least one supply air damper.
  • the invention will then activate an air phase anti-microbial agent generator, configured to fill the chamber with air phase anti microbial agents at a time and dose level configured to kill at least a substantial majority of microbes in said chamber.
  • the invention will deactivate the generator, and set the dampers (e.g.
  • the air phase anti-microbial agents can be rapidly purged to the outside air. This laher option is particularly useful for emergency purge situations, and/or when a rapid stop of the sterilization process mid-cycle is desired.
  • the invention may be a healthcare chamber system configured to reduce a risk of HAI.
  • This system will often comprise at least one computer processor and at least one sensor, as well as a chamber configured to return interior air from said chamber by using at least one return air damper.
  • This chamber will typically comprise air impermeable chamber walls, celling, and floor, as well as various openings (that can be closed by various devices), such as doors and air ducts.
  • This chamber will further typically comprise a ceiling mounted structural device comprising a load-bearing structure, with a laminar air flow system mounted on this structural device.
  • This laminar air flow system will typically be configured to blow HEPA filtered and UV sterilized supply air over a defined field in this chamber.
  • This laminar air flow system is in turn connected to at least one supply air damper.
  • the chamber will typically be configured to obtain interior air by using the ceiling mounted structural device and the laminar air flow system to obtain sterilized outside air, and blow HEPA filtered and UV sterilized supply air over a defined field in this chamber.
  • the laminar air flow system is also typically connected to at least one supply air damper.
  • the at least one computer processor and at least one sensor will verify that no humans are present in the chamber and then restrict access to the chamber. Then, typically after this optional verification and access restriction, the system can use at least one computer processor also configured to isolate an interior air flow in the chamber from outside air by closing at least one return damper and at least one supply air damper.
  • This at least one computer processor is typically also configured to activate an air phase anti-microbial agent generator.
  • This generator is typically configured to fill the chamber with air phase anti microbial agents at a time and dose level configured to kill at least a substantial majority of microbes in the chamber.
  • the system can use at least one computer processor also configured to deactivate the generator and to flush remaining air phase anti-microbial agents from the chamber by at least opening the (air) return damper and at least one (air) supply damper.
  • Figure 1 shows an example of an operating room type chamber configured according to certain embodiments of the invention.
  • Figure 2 shows an embodiment of the operating room or chamber configured with an operating table and various types of boom mounted operating room equipment.
  • Figure 3 shows how the invention may operate between cycles of sterilization.
  • Figure 4 shows how the invention may operate during the initiation of a sterilization cycle.
  • Figure 5 how the invention may operate during a normal termination of a sterilization cycle.
  • Figure 6 how the invention may operate during an accelerated or“emergency purge” termination of a sterilization cycle.
  • Figure 7A shows a top-down view of a portion of an operating room type chamber as seen from the perspective of a viewer positioned above the invention’s ceiling mounted structural device.
  • Figure 7B shows a detail of how the ceiling mounted structural device may be mounted in the ceiling of an operating room.
  • Figure 8A shows an alternate view of the laminar array portion of the ceiling mounted structural device, here equipped with some additional perimeter lights and perimeter conduit paths.
  • Figure 8B shows a view of the interior of the laminar array portion of the ceiling mounted structural device when all of the perforated panels of its various laminar air flow systems have been removed.
  • Figure 9A shows a long axis side view of an individual laminar air flow system module. Here more details of the air supply connection and damper and the LED drivers (used to power the system’s Light Emitting Diodes) may be seen.
  • Figure 9B shows a view looking up at the face of an individual air flow system module. Here details of the perforated wall structure and LED lighting may be seen.
  • Figure 9C shows a short axis side view of an individual laminar air flow system module.
  • the term“chamber” will often be used as a generic term for the room where the invention’s systems and methods are being applied.
  • hospital or clinic operating rooms are often used as specific examples for this type of room, these examples are not intended to be limiting.
  • the invention’s systems and methods may also be applied to non-operating room hospital or clinic rooms, such as Intensive Care Units (ICU), and may be particularly useful where immunocompromised or infectious patients may be treated.
  • ICU Intensive Care Units
  • the invention may also be useful for mobile clinics, field hospitals, combat support hospitals, and the like.
  • microbial or“microbe” will be used to discuss bacteria, fungi, spores, viruses, and other microscopic pathogens, in particular, microscopic pathogens associated with Hospital Acquired Infections (HAI) and Surgical Site Infections (SSI).
  • HAI Hospital Acquired Infections
  • SSI Surgical Site Infections
  • HAI HAI
  • SSI SSI
  • “damper” will often be used as a term for a valve or plate used to regulate the flow of air inside of a duct or other type of air handling device.
  • the dampers are equipped with solenoids, motors, or other actuator mechanisms that allow the dampers to be opened or shut by a control mechanism, which may be a computerized control mechanism.
  • a control mechanism which may be a computerized control mechanism.
  • the term“valve” and“damper” are often used as alternate expressions for the same thing.
  • the invention may be a device, system or method of reducing the risk of HAI (e.g. by reducing the microbial burden of a room used in patient care).
  • This invention relies, in part, on a combination of airborne antimicrobial agents to find and inactivate microbes on various surfaces and items in the room, and laminar air flow systems configured to use air curtains of sterilized air to help direct microbes away from patients.
  • the invention may comprise various devices and various steps, typically processor controlled steps, all working together as a larger device or system.
  • the invention operates by optionally verifying (often by automatic devices) that no humans are present in the chamber and then (again often by automatic devices) restricting access to this chamber prior to the commencement of sterilization.
  • This optional verification step can be done automatically by, for example, using at least one computer processor and at least one sensor configured to verify that no humans are present in the healthcare chamber, and prior to a start of a sterilization cycle when no humans are present in the chamber, to restrict access to the chamber.
  • this optional verification step can be done manually.
  • the chamber will preferably comprise air impermeable chamber walls, ceiling, and floor, although in some cases, walls or ceilings with limited porosity may also work so long as the porosity is limited enough as to constrain sterilizing agents inside the chamber, and to constrain the migration of microbes outside the chamber from migrating through the walls to inside the chamber.
  • the walls of the chamber will typically be made of a material that is easy to clean, and that is not adversely affected by the sterilizing agents. Here materials such as glass and stainless steel, or other material able to withstand degradation by the sterilizing agent may be used.
  • Chambers intended for human occupancy typically provide air flow by providing a system by which outside air can enter into the chamber, and interior air inside the chamber can return to the outside air. Often this air flow is controlled by appropriate dampers.
  • the invention will typically operate by isolating (often by automatic devices), the interior air flow in the chamber from outside air by closing at least one return damper (typically actuator controlled) and at least one supply air damper (also typically actuator controlled).
  • this sterilized outside air may be distributed inside the chamber using a laminar array (laminar air flow system) mounted or associated with a ceiling mounted structural device.
  • This laminar array portion of the ceiling mounted structural device will typically comprise a load-bearing structure, with a laminar air-flow system mounted on the structural device.
  • This laminar air flow system may be configured to blow sterile air (typically HEPA filtered and UV sterilized supply air) over at least a defined field in the chamber, often forming an air curtain around this defined field. For an operating room, this defined field may be the operating table.
  • this laminar air flow system will be connected to the at least one supply air damper
  • the invention may operate by closing (often by automatic devices) at least one (actuator controlled) supply air damper, and activating (often by automatic devices) an air phase anti-microbial agent generator.
  • This generator will typically be configured to fill the chamber with air phase anti-microbial agents, such as a hydrogen peroxide vapor or mist, and to keep the levels of these agents elevated for a time and dose level configured to kill at least a substantial majority of the chamber’s microbes.
  • the invention may also monitor the environment inside the chamber, and adjust other parameters, such as temperature and humidity, so that the sterilizing agent acts in a consistent and predictable manner.
  • the invention will then typically (often by automatic devices) deactivate (e.g. turn off) the generator, and flush (again often by automatic devices) any remaining air phase anti-microbial agents from the chamber by, for example, at least opening the (actuator controlled) return damper and opening the at least one (actuator controlled) supply damper. Fans may also be activated as appropriate. This acts to flush the air phase antimicrobial agents from the chamber.
  • the net result is to obtain an operating room with an unusually low microbial burden, and configured, even after the sterilization cycle, to keep the microbial burden low over at least certain defined fields or regions of the chamber (e.g. over the operating table) by providing laminar flow sources of sterile air that, for example, may provide an air curtain against any airborne microbes carried by dust particles or droplets entering these regions or fields.
  • FIGS 1 and 2 show an example of such an operating room type chamber (100) configured according to certain embodiments of the invention.
  • the invention On the ceiling, the invention’s ceiling mounted structural device (101) can be mounted.
  • this structural device (101) can support a modular grid system with a load-bearing structure configured to accommodate multiple types of ceiling mounted devices with various weights (loads) and dimensional tolerances.
  • This structural device (modular structural grid) (101) may thus support the ceiling (e.g. provide an apparent ceiling to inside observers), the laminar array, medical equipment, as well as access to various hospital or clinic utilities (e.g. power, medical gas, etc.) as desired.
  • a prefabricated structural system such as a system of powder-coated structural steel grids, to form a plurality of internal grids configured to provide underlying support for the array of laminar flow devices, medical equipment, and utilities held by structural device (101), see also Figure 7B (702).
  • the ceiling mounted structural device may have a generally polygonal shape, such as a rectangular shape, or a more complex shape formed from a plurality of rectangles.
  • This ceiling mounted structural device may be further configured with a plurality of internal grids.
  • at least some of these grids may be configured to accommodate electrical conduits, preferably larger conduits with diameters of around 2 inches for maximum compatibility with a broad range of additional equipment, such as equipment useful for Operating Room (OR) purposes.
  • At least some of these grids or other grids may be configured to supply structural support for additional equipment, such as for standard operating room utility pendants/booms, surgical lights, and other boom-mounted equipment. This is shown in more detail in Figure 2. See also Figures 7A-8B.
  • the ceiling-mounted structural device (101) will also typically have various mounted laminar air flow systems (102), which will introduce clean HEPA filtered (and often UV sterilized) supply air into the operating room, often through perforations in the overhead lighting fixtures (l02a) (perforated panels).
  • This laminar air flow system (102) will often be designed so as to produce a perimeter air curtain (l02b) over a defined field of the operating room, such as in the region (l30a) where an operating table may be placed.
  • the lighting system may incorporate integrated lighting, such as an integrated light emitting diode (LED) lighting. This lighting may be disposed in a perimeter (l02c) around the perforated panels (l02a), or in other locations.
  • LED integrated light emitting diode
  • this laminar air flow system may, in a preferred embodiment, further comprise a plurality of air curtains that produce a plurality of directionally-controlled airstreams (l02b). This is often referred to in the alternative as a“laminar array”. These airstreams are configured to reduce penetration of particles from an area outside of the operating table to an area inside the operating table.
  • the walls of the chamber (104) will often comprise materials selected to be easy to clean and sterilize, and resistant to any deterioration caused by air- phase anti-microbial agents such as hydrogen peroxide (H2O2).
  • H2O2 hydrogen peroxide
  • These materials can comprise medical grade glass (or glass-like material), stainless steel, or other easy to clean materials that are resistant to deterioration caused by the airborne sterilizing agent(s).
  • the walls (104) may or may not have illumination or customized backgrounds. In some embodiments, it may even be useful to put computer controlled display screens behind transparent walls so that the appearance of the operating room can be customized according to the needs at hand.
  • the wall displays may, for example, be configured to a pleasant and reassuring display to show patients upon entry. The wall displays can then reconfigured during an operation, as desired, to show images containing medical information, thus making it easy for physicians to request additional data in an easy to see format, as desired.
  • At least the substantial majority (e.g. greater than 50% and often greater than 90%) of the chamber’s walls may be covered with materials, such as glass or stainless steel, selected to be resistant to the particular air phase anti-microbial agents that are being used.
  • the invention will also comprise an air phase antimicrobial agent generator (106), such as a hydrogen peroxide vaporizer/fogger/aerosol generating unit shown here as a particular example.
  • This generator may operate according to methods of Pomeroy (US 2014/0037496), Watling (US 7,186,371), Shannon (US 8,551,399) or other methods.
  • This generator (106) may further comprise a control touchscreen (l06a), such as a hydrogen peroxide fogging control touchscreen, and containers of the antimicrobial agent (l06b), such as modules configured to hold bottles of hydrogen peroxide.
  • the generator may operate by converting an aqueous solution of hydrogen peroxide into air phase hydrogen peroxide by using any of a misting, nebulizer based, vaporizing based, or aerosol generating type process.
  • the air phase anti-microbial agent generator may be a combination generator and humidifier that also operates by regulating humidity, or alternatively the chamber may contain humidity and/or temperature sensors and regulating equipment that operates independently of the generator.
  • the invention will also comprise one or more medical grade touch- workstations (l08a, l08b) for medical information, medical images, and other digital media.
  • This workstation may optionally be integrated into the glass walls (104) of the chamber for greater sterility and to protect the workstation electronics.
  • Other touch panels may also be provided for other functions, such as controlling other room lighting (111).
  • the invention will further comprise at least one computer processor, which will be configured to control many or all of the invention’s various steps.
  • this (at least one) computer processor may be used (often in conjunction with various occupancy sensors). Prior to the start of a sterilization cycle, this computer processor may use the occupancy sensors to first verify that no humans are present in the chamber and then to restrict access to the chamber (e.g. by automatically locking doors) so that outsiders cannot accidentally enter.
  • Various safety overrides can, of course, also be incorporated into the system.
  • this at least one computer processor may also be used to isolate interior air flow in the chamber from outside air by closing at least one computer controlled return damper and at least one computer-controlled supply air damper (here assume that the chamber is configured to return interior air from inside the chamber to the outside using this at least one computer controlled return air damper). See Figure 4 for more detail.
  • the laminar air flow system may also be connected to at least one computer-controlled supply air damper, and the system’s (at least one computer processor) may be used to activate the air phase anti-microbial agent generator (106).
  • the system’s (at least one) computer processor may also be used to deactivate this anti-microbial agent generator (106), and to flush any remaining air phase anti-microbial agents from the chamber by opening the computer controlled return damper and the (at least one) computer-controlled supply damper.
  • this (at least one) computer processor may be controlled and monitored by using at least one touch-panel equipped graphical user interface terminal.
  • This terminal may be mounted either on an interior chamber wall (110) or exterior to the chamber, or in both places.
  • FIG 1 shows an example of this type of computer processor control unit (110), which optionally may also be integrated or embedded into or behind the glass walls (104) of the chamber.
  • control units will often include a master system control-touch panel. This can be used for controlling at least portions of the sterilization process, sterilization safety systems (e.g. door locks, sensors), and the like.
  • sterilization safety systems e.g. door locks, sensors
  • This or an alternative control panel may also be used to control other aspects of the chamber’s environment, such as lighting, air conditioning, and the like. To prevent accidental misuse, it may be preferable to separate the sterilization control panel from the control panel used to implement more standard aspects of the chamber, such as lighting.
  • the chamber (100) will also typically comprise at least one door (112) or door system.
  • This door system will typically be configured to hermetically seal when shut, and also will be configured with locks, such as computer-controlled locks.
  • these computer controlled locks will usually have a manual override.
  • the door will also usually have one or more windows (1 l2a) so that outside observers can visually confirm the occupancy status of the room. If exterior sterilization control panels are used, it may be desirable to locate these control panels so that anyone using the control panel can look through a window and see what is happening. Alternatively, an outside control panel can also incorporate video displays of the inside of the chamber. Again, the idea is to make sure that no one is present in the chamber before sterilization begins.
  • the chamber (100) will be equipped with at least one-way computer operated door locks.
  • using the at least one computer processor to restrict access to the chamber can (for example) comprise setting these at least one-way computer door locks to restrict humans outside the chamber from entering into the chamber.
  • it would be useful to configure the locks so that any humans inadvertently left inside the chamber can manually exit even after sterilization starts. It may also be useful to configure the doors with manual“open” overrides on the outside as well.
  • the at least one computer processor can be used to monitor at least one occupancy sensor (see Figure 4, 400), and preferably a plurality of different occupancy sensors, to reduce the chances of error.
  • occupancy sensors may include one or more motion sensors, infrared sensors, video cameras, carbon dioxide sensors, sound sensors, and the like.
  • the chamber will also typically comprise a catalytic extraction unit comprising a room air intake, at least one fan, at least one a computer controlled catalyst damper, and a catalyst (catalytic converter) to deactivate any remaining air-phase
  • this catalytic extraction unit can also be used as an emergency purge loop while in other embodiments (see Figure 6), during emergency operation, for higher exhaust rates, the catalytic portions may be temporarily bypassed.
  • the system may use at least one computer processor to turn on at least one fan to further flush remaining air phase anti microbial agents from the chamber.
  • the system may additionally, or alternatively, use at least one computer controlled catalyst damper and a catalyst (catalytic converter) to deactivate any remaining air-phase anti-microbial agents.
  • the catalyst will typically act to degrade the air phase anti-microbial agents into harmless molecules.
  • the air-phase antimicrobial agents are hydrogen peroxide (H2O2)
  • the catalyst may degrade these agents into harmless molecules such as water (H 2 0) and oxygen (0 2 ).
  • the chamber (100) may be further equipped with at least one anti-microbial agent sensor configured to monitor the levels, concentrations, or amounts of the air-phase anti-microbial agents present in the chamber air.
  • this at least one anti-microbial agent sensor can further be configured to transmit data to the at least one processor used to control the system.
  • this at least one processor may be configured to set the at least one-way computer door locks and door (112) so that the door only allows humans to enter the chamber after the anti-microbial agent sensor(s) report that the air phase anti-microbial agents are at a non-toxic level.
  • a more conventional air return (115) may be used.
  • Figure 2 shows an embodiment of operating room or chamber (100), here configured with an operating table (200) and various boom mounted operating room equipment e.g. (shelves 202, lights 204, monitor 206) mounted on booms that are supported by the ceiling mounted structural device (101).
  • various boom mounted operating room equipment e.g. (shelves 202, lights 204, monitor 206) mounted on booms that are supported by the ceiling mounted structural device (101).
  • Figure 3 shows an embodiment showing how the invention’s chamber sterilization equipment may act during normal operation, such as in between sterilization cycles, when the room may be occupied by physicians, patients, and other humans.
  • the system contains many computer connected and controlled air dampers (dampers), fans, and drivers that may, for example, be controlled by at least one computer processor.
  • This at least one computer processor may form part of a control unit (110), or may form part of another control unit as desired.
  • the air passes through various optional HEPA filters and/or UV sterilizers (not shown) and will typically enter the chamber through the various mounted laminar air flow systems (102, l02a) previously shown in Figure 1, and may form air curtains (l02b) as desired.
  • Return air exits the chamber via an air return, such as Figure 1 (115).
  • This return air is directed outside the chamber via normally open damper (air valve) BTD-2 and through the return air valve (RAV). This process may be assisted by various fans, as desired (not shown).
  • Figure 4 shows an embodiment of how the system may operate during a sterilization cycle.
  • the system’s computer processor will normally check the status of at least one occupancy sensor (400), and preferably a plurality of occupancy sensors operating by more than one detection modality, before initiating this sterilization cycle.
  • This process may be controlled by suitable touch panel mounted graphical interface terminals mounted either inside the chamber (e.g. on an interior chamber wall, such as 110), or outside the chamber (e.g. 1 lOa), or in both places.
  • the computer processor After verifying that the chamber (100) is empty, will then restrict access to the chamber by, for example, automatically locking door (112).
  • the computer processor may monitor and adjust the room air humidity and temperature using appropriate sensors (402, 404), and optionally also monitor and adjust room static pressure as well, to optimize the integrity of the sterilization process.
  • the computer directs normally open air valve (damper) BTD-l to shut, and there is no air entering the room through the laminar flow system (102).
  • the air phase anti-microbial agent generator (106) is turned on, flooding the chamber (100) with an air bom sterilizing agents such as hydrogen peroxide vapor or mist.
  • Normally open air valve or damper (BTD-2) is also computer directed to be shut, and normally closed dampers BTD-4 and BTD-5 are also directed to remain shut.
  • the sterilizing agent remains trapped in chamber (100), where it will sterilize the room and its various contents.
  • the computer processor may continue to monitor and adjust the room air humidity and temperature using appropriate sensors (402, 404), and optionally also monitor and adjust room static pressure as well, to help further ensure the integrity of the sterilization process.
  • Other sensors may also be used to monitor levels of air-phase anti-microbial agents as well.
  • Figure 5 shows how after sterilization, room (chamber) air may be exhausted through a catalytic system in order to remove any remaining sterilizing agent, and to once again make the room suitable for occupancy.
  • the air phase antimicrobial agent generator (106) will be turned off, either by the system’s computer processor, exhaustion of anti-microbial agents, or other method.
  • the room air which contains the air-phase antimicrobial agent, exits the room through the appropriate return air register (114 or 115).
  • the computer closes normally open air valve (damper) BTD-2, and keeps normally closed air valve (dampers) BTD-5 and BTD-l closed as well.
  • the computer opens normally closed air valve (damper) BTD-4 and BTD-3, and turns on recirculation fan RF-l.
  • Figure 6 shows an alternate Emergency purge/Rapid exhaust process method of quickly removing anti-microbial agents from chamber (100).
  • the system turns off the air phase antimicrobial agent generator (106).
  • the system bypasses the catalytic converter and recirculation system. Instead, the computer opens normally closed air valve (damper) BTD-5, and activates exhaust fan EF-l.
  • the normally open damper BTD-2 is closed, and the normally closed damper BTD-4 continues to remain closed.
  • the chamber air with its anti-microbial agents, may be directed outside the building via EA (600).
  • HEP A filtered supply air (602) passes though the supply air valve (SAV), is optionally heated or reheated as desired, and this clean air, free of anti-microbial agents, enters the room through the laminar air flow systems (102).
  • SAV supply air valve
  • All operations shall be controlled by an operating room specific controller and shall have full BacNet interface with the facilities Building Automation System (BAS). Each Operating Room (100) will have an Operator’s Graphical Interface (OGI, 110, 110a). All set points and adjustments can be made at the OGI or at the facilities BAS.
  • OGI Graphical Interface
  • SAV Supply Air Valve
  • RAV Return Air Valve
  • ACH Air Changes per Hour
  • Operating room space temperature shall be maintained + 72F (adjustable) by modulating the flow of heating water to a reheat coil.
  • Operating room space humidity will be maintained at 50% RH (adjustable) by regulating output of a localized humidifier. If humidity control is provided at the base building air handling unit, the OGI shall monitor and report the space humidity condition.
  • Each Operating Room will have an Operator’s Graphical Interface (OGI) (e.g. 110, 110a). All set points and adjustments can be made at the OGI, Hydrogen Peroxide generator (106) or at the facilities BAS. (Note, BACnet is a communications protocol for building automation and control networks, and is now exemplified by ISO standard 16484-5.)
  • OGI Graphical Interface
  • BACnet is a communications protocol for building automation and control networks, and is now exemplified by ISO standard 16484-5.
  • A. Room sterilization operation shall be initiated by a time of day command or from a manual operator’s command from the OGI. Manual override of a time of day start will be made at the OGI prior to the start of sterilization sequence of operation.
  • the room (100) Upon initialization of the sterilization sequence the room (100) shall be confirmed to be unoccupied by at least one local occupancy sensor (400) within the operation room. Upon verification of zero occupancy a countdown timer shall indicated the sterilization cycle is ready to begin. The OGI shall indicate the room is vacant of occupants and ready for sterilization.
  • the operating room doors (112) shall close and lock and the OGI shall indicate confirm the status of the doors. This status shall be confirmed by end switches on the door slides as well as the electro lock (door lock). Red LED lighting integral to the space shall be illuminated to indicate the room is not safe for inhabitants. Manual kill switches/Door releases shall be located adjacent to all points of egress within the room. Upon activation of a Kill Switch/Door release the system will require an operator resent at the OGI.
  • the operating room Upon confirmation and indication of the operating room doors (112) being closed and locked, the operating room shall be isolated from the main building air handling units by closing bubble tight control dampers (BTD).
  • BTD bubble tight control dampers
  • the SAV and RAV shall close in conjunction with dampers BTD-1 and BTD-2.
  • the heating water valve on the operating room reheat coil shall be closed and the humidifier shall cycle off for the duration of the sterilization sequence.
  • the status off the dampers shall be indicated on the OGI.
  • the sequence shall pause for a minimum of 300 seconds (adjustable) to assure the room is air is calm and all directional movement and turbulence has ceased.
  • the status of the operation shall be indicated on the OGI.
  • the room sterilization system ( 106) shall activate the hydrogen peroxide generator.
  • the hydrogen peroxide generator shall sterilize the room based upon the onboard control systems. All status changes and actions shall be monitored at the OGI and the building automation system.
  • G. The hydrogen peroxide agent shall remain in the room until such time the generators onboard controls determine the room saturation has been achieved and the agent is ready to be evacuated.
  • RC-1 Upon completion of the sterilization process, RC-1 shall deactivate and BTD-3 and BTD-4 shall close. Upon confirmation of closure of BTD-3 and BTD-4, BTD-1 and BTD-2 shall open. Upon confirmation of the open status of BTD-1 and BTD-2, SAV andRAV shall resume standard operation.
  • the heating water reheat coil and humidifier shall be reactivated and shall operate in sequence until the operating room returns to its original adjustable set points. All activity and status shall be controlled and indicated at the OGI.
  • OGI shall indicate the OR is safe for occupancy and is ready for use.
  • Figure 7A shows a top-down view of a portion of the operating room (100) as seen from the perspective a viewer positioned above the ceiling mounted structural device (101).
  • the observer is looking past the various laminar air flow systems (102) as if they were transparent or semi-transparent.
  • the observer is also looking past various types of boom mounted equipment (e.g. monitors 206, shelves 202, lamps, etc.) and onto the top of an operating table (200) with a patient (700).
  • the operating table will be aligned with the orientation of the ceiling mounted structural device (101) and the various laminar air flow systems (102) so as to create an air curtain (Figure 1, l02b) that sweeps the operating field clear of potentially microbe containing airborne particles.
  • the exterior dimensions of the polygonal shape of the ceiling mounted structural device (101) may exceed the exterior dimensions of the operating table (200).
  • this polygonal shape may be a rectangular polygonal shape (or at least may be composed of a plurality of rectangular polygonal shapes).
  • the various laminar flow devices on the ceiling mounted structural device may be configured to produce a plurality of air curtains that may, for example, extend on all sides of a perimeter of the rectangular polygonal shape.
  • the ceiling mounted structural device and its various laminar air flow devices may be configured so that this air curtain perimeter will exceed the exterior dimensions of the operating table (200). This configuration will help further isolate the operating table (200) and the patient (700) from microbes home on airborne particles originating from outside of the operating table.
  • this laminar air flow system may be disposed on one or more interior structures within the rectangular shape of the ceiling mounted structural device (101). These laminar air flow systems may introduce an air flow configured to flush airborne particles from the area of the operating table (200) to an area outside of the operating table.
  • At least some of the internal grids in the ceiling mounted structural device may be configured to accommodate electrical conduits with widths of at least 2 inches. Further, at least some of the internal grids may comprise weigh supporting members, some of which may be further equipped with flanges or other mechanical supports configured to supply structural support for standard operating room boom mounted equipment. See Figure 7B for more examples.
  • FIG. 7B shows a detail of how the ceiling mounted structural device (101) may be mounted in the room.
  • the ceiling mounted structural device (101) may either be a“false ceiling” that is mounted to structural support on the“real ceiling”, or alternatively the ceiling mounted structural device may be suspended using modular support framing (702) or other type framing to various types of building structural supports (not shown).
  • This modular support framing (702) may also be used to provide mechanical support for heavy boom mounted equipment (704) such as (202, 204, 206 etc.). This type of heavy boom mounted equipment is shown in Table 2 below.
  • Table 2 Boom and Lighting mount size (inches), weights & moments
  • FIG 8A shows an alternate view of the laminar array portion mounted on the ceiling mounted structural device (101), here equipped with some additional perimeter lights (800) and perimeter conduit paths.
  • all of the mounted laminar air flow systems (102) are equipped with perforated panels (e.g. a perforated panel facing the room) (l02a) so that air can flow gently into the room through a series of small openings (perforations).
  • perforated panels include the laminar flow diffusers produced by Krueger- HVAC, and other sources.
  • Figure 8B shows a view of the plenum which provides air to the laminar array. Essentially, this can also be considered to be a view of a portion of the interior of the ceiling mounted structural device (101) when all of the perforated panels (l02a) of the mounted laminar air flow systems have been removed.
  • Each laminar air flow system (102) has its own damper and air supply connection (802). Note that dampers (802) need not be equipped with actuators, and need not be computer operated dampers (although in some embodiments, they may be) since air to the system can be controlled by other dampers, such as damper BTD-l shown in Figure 3.
  • LED drivers (804) used to drive the LED lighting system are also shown.
  • Figure 9A shows a long axis side view of an individual laminar air flow system module (102). Here more details of the air supply connection and damper (802) and the LED drivers (804) may be seen.
  • modules such as the Krueger Sterilfo System®, SterilflexTM system, or alternative systems, may be used.
  • the laminar air flow system may also include UV lights configured to provide further UV sterilization to the incoming HEPA filtered air.
  • UV sterilizing systems such as Steril-Aire UVC emitter system, produced by Steril-Aire, Inc. may be used.
  • Figure 9B shows a view looking up at the face of an individual air flow system module (102). Here details of the perforated wall structure (l02a) and LED lighting (102) may be seen.
  • Figure 9C shows a short axis side view of an individual laminar air flow system module (102). This shows a detail of the air supply connection and damper (802) from a different perspective.
  • SterilflexTM is a trademark, and Sterilfo System® is a registered trademark, of Lau Industries, Inc., a Delaware Corporation.

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Abstract

L'invention concerne un dispositif, un système et un procédé destinés à réduire le risque d'infections de patient (HAI), à l'aide de salles d'opération équipées de générateurs automatiques d'agent de stérilisation aéroporté, de capteurs, de mécanismes, de dispositifs de commande d'air automatique, et de structures montées au plafond appropriés qui permettent à la pièce de fournir des rideaux d'air constitués d'air stérilisé à écoulement laminaire sur la table d'opération, ainsi que d'être rapidement et complètement stérilisée. Après des vérifications de sécurité appropriées, le système isole l'air intérieur de l'air extérieur, et active un générateur d'agent antimicrobien en phase d'air, remplissant la pièce d'agent antimicrobien en phase d'air. Après la stérilisation, l'invention désactive le générateur, élimine l'agent antimicrobien en phase d'air restant par écoulement d'air ambiant à travers un convertisseur catalytique, puis restaure la connexion à l'air stérilisé extérieur. La structure montée au plafond est conçue pour une distribution de rideau d'air à écoulement laminaire, un éclairage d'appoint et un équipement de salle d'opération monté sur une perche de support. L'invention concerne également divers capteurs, procédés de commande, revêtements muraux.
PCT/US2018/050131 2018-09-09 2018-09-09 Conceptions et procédés de stérilisation pour chambres d'hôpital et salles d'opération WO2020050864A1 (fr)

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WO2021232000A1 (fr) * 2020-05-15 2021-11-18 Delta T, Llc Système de ventilateur pour améliorer la qualité de l'air intérieur et procédés associés
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US11400177B2 (en) 2020-05-18 2022-08-02 Wangs Alliance Corporation Germicidal lighting
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WO2021232000A1 (fr) * 2020-05-15 2021-11-18 Delta T, Llc Système de ventilateur pour améliorer la qualité de l'air intérieur et procédés associés
US11400177B2 (en) 2020-05-18 2022-08-02 Wangs Alliance Corporation Germicidal lighting
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