WO2012044944A2 - Device for disinfecting and/or rinsing endoscopes with limited escape of fumes - Google Patents

Device for disinfecting and/or rinsing endoscopes with limited escape of fumes Download PDF

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Publication number
WO2012044944A2
WO2012044944A2 PCT/US2011/054247 US2011054247W WO2012044944A2 WO 2012044944 A2 WO2012044944 A2 WO 2012044944A2 US 2011054247 W US2011054247 W US 2011054247W WO 2012044944 A2 WO2012044944 A2 WO 2012044944A2
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WO
WIPO (PCT)
Prior art keywords
basin
reservoir
coupled
liquid
endoscope
Prior art date
Application number
PCT/US2011/054247
Other languages
French (fr)
Other versions
WO2012044944A3 (en
Inventor
Norman Miner
Original Assignee
Healthpoint, Ltd.
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 Healthpoint, Ltd. filed Critical Healthpoint, Ltd.
Priority to AU2011308621A priority Critical patent/AU2011308621B2/en
Priority to CN201180054461.1A priority patent/CN103347435B/en
Priority to KR1020137011076A priority patent/KR101802382B1/en
Priority to NZ610039A priority patent/NZ610039A/en
Publication of WO2012044944A2 publication Critical patent/WO2012044944A2/en
Publication of WO2012044944A3 publication Critical patent/WO2012044944A3/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/12Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with cooling or rinsing arrangements
    • A61B1/121Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with cooling or rinsing arrangements provided with means for cleaning post-use
    • A61B1/125Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with cooling or rinsing arrangements provided with means for cleaning post-use using fluid circuits
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/12Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with cooling or rinsing arrangements
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/10Furniture specially adapted for surgical or diagnostic appliances or instruments
    • A61B50/13Trolleys, e.g. carts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, 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
    • A61B90/70Cleaning devices specially adapted for surgical instruments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/18Liquid substances or solutions comprising solids or dissolved gases
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, 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
    • A61B90/70Cleaning devices specially adapted for surgical instruments
    • A61B2090/701Cleaning devices specially adapted for surgical instruments for flexible tubular instruments, e.g. endoscopes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2202/00Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10Apparatus features
    • A61L2202/17Combination with washing or cleaning means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2202/00Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20Targets to be treated
    • A61L2202/24Medical instruments, e.g. endoscopes, catheters, sharps

Definitions

  • the present invention relates generally to disinfection and/or rinsing; and more particularly, but not by way of limitation, to high-level disinfection and/or rinsing of endoscopes.
  • Endoscopes e.g., heat-sensitive, semi-critical, and/or flexible fiberoptic endoscopes such as gastroscopes, colonoscopes, bronchoscopes, laryngoscopes, and cystoscopes
  • gastroscopes e.g., heat-sensitive, semi-critical, and/or flexible fiberoptic endoscopes
  • colonoscopes e.g., gastroscopes, colonoscopes, bronchoscopes, laryngoscopes, and cystoscopes
  • cystoscopes e.g., heat-sensitive, semi-critical, and/or flexible fiberoptic endoscopes such as gastroscopes, colonoscopes, bronchoscopes, laryngoscopes, and cystoscopes
  • cystoscopes often must be thoroughly cleaned, rinsed to remove the cleaning agents, disinfected with high level disinfectants, and rinsed to remove the disinfectants, before use with each patient.
  • Vapors from high level disinfectants such as alkaline glutaraldehyde, glutaraldehyde plus isopropanol, ortho-phthalaldehyde, and peracetic acid solutions may irritate and sensitize the skin, eyes, and mucous membranes of the medical personnel who work with these disinfectants in open basins to reprocess the flexible endoscopes.
  • AER Automatic endoscope reprocessing machines
  • An endoscope may be placed into the basin of an AER, where disinfectant solutions and subsequently rinse water can be automatically transferred in and out of the basin.
  • the endoscope may also be connected to tubing to automatically flush the disinfectants and rinse water through the internal air, water, and working (biopsy) channels of the endoscopes. Operation of an AER is typically controlled and performed automatically by a programmable CPU.
  • the disinfectant reservoir and the basin of the AER may be enclosed, and may sufficiently contain the vapors of the high level disinfectant in the reservoir and basin of the AER, to protect the workers from the vapors.
  • AER machines are generally expensive, and can cost from $30,000 to $40,000.
  • Many are also limited to disinfecting and rinsing at most two flexible endoscopes at the same time, and often require about 30 to 40 minutes per reprocessing cycle.
  • the air space immediately above the disinfectant solution in the basin may be in the operator's breathing zone, and unless the operator is wearing a breathing mask (a gas mask) that covers the eyes, nose, and mouth, the operator may come into contact with the vapors of the disinfectant. Even if the operator is wearing a breathing mask, vapors of the disinfectant solution may escape into the air of the reprocessing space such as a chemical fume hood, or the air of the reprocessing room and can irritate exposed skin or other personnel in the area.
  • a breathing mask a gas mask
  • the endoscope After the endoscope has been exposed to the high level disinfectant, then the endoscope is generally transferred to another basin holding fresh rinse water, and may be manually flushed with the rinse water. This rinsing procedure is generally repeated three times with fresh rinse water each time to dilute the chemicals of the high level disinfectant to the level of no observable toxic effect. This process of transfer and rinsing of the endoscope again has the potential to release fumes of the disinfectant to the surrounding air.
  • Glutaraldehyde is a high level disinfectant with a long history of use, and glutaraldehyde plus 20% w/w isopropanol is another disinfectant that is generally more antimicrobially effective than Glutaraldehyde. Both of these disinfectant solutions may cause irritation and sensitization of personnel caused by the fumes/vapors of glutaraldehyde (e.g., fumes of glutaraldehyde released during manual disinfection of endoscopes). Solutions of ortho-phthalaldehyde (OP A) are increasingly used because the relatively low vapor pressure of OPA reduces the vapors that can escape from solutions of OP A.
  • OPA ortho-phthalaldehyde
  • OPA is generally not considered to be a sterilant, and may not kill at least one common spore-forming bacteria: Bacillus subtilis. These surviving bacteria may initiate formation of biofilms within endoscopes, after which the endoscope may be difficult or impossible to disinfect.
  • OPA is also generally considered to be a potent allergen, and cases of anaphylactic shock have been reported in scientific literature believed by some to be due to use and re-use of endoscopes disinfected with OPA. Labels of OPA solutions generally carry a warning against the use of OPA with certain endoscopes (e.g., cystoscopes, used to monitor bladder cancer patients).
  • OPA has relatively low solubility in water, and one recent publication demonstrates that OPA adsorbs onto endoscope surfaces and may not be adequately rinsed away even with excessive numbers of rinses.
  • the present disclosure includes embodiments of systems and methods for disinfecting and/or rinsing endoscopes (e.g., while reducing user exposure to fumes).
  • Some embodiments of the present apparatuses for disinfecting and/or rinsing an endoscope comprise: a basin including a body and a lid, the body configured to receive an endoscope such that the endoscope can be submersed in liquid with a headspace in the basin above the liquid, the lid configured to be coupled to the basin to provide a substantially airtight seal between the lid and the body; a reservoir with a top, the reservoir configured to receive a liquid with a headspace between the liquid and the top; a disinfectant supply conduit coupled to the basin and to the reservoir, and configured to communicate liquid from the reservoir to the basin; and a gas conduit coupled to the basin and to the reservoir, the gas conduit configured to communicate gas between the headspace of the basin and the headspace of the reservoir.
  • Some embodiments further comprise: a water supply conduit coupled to the basin, and configured to be coupled to a water source to communicate water to the basin. Some embodiments further comprise: a filter coupled to the water supply conduit. Some embodiments further comprise: a disinfectant drain conduit coupled to the basin and to the reservoir, and configured to communicate liquid from the basin to the reservoir. Some embodiments further comprise: a disinfectant drain valve coupled to the disinfectant drain conduit and configured to be actuated to substantially prevent liquid communication between the basin and the reservoir. Some embodiments comprise a waste drain conduit coupled to the basin, and configured to communicate liquid out of the basin. Some embodiments further comprise: a waste drain valve coupled to the waste drain conduit and configured to be actuated to substantially prevent liquid communication out of the basin through the waste drain conduit. In some embodiments, the waste drain conduit is configured to communicate waste from the basin to a waste receptacle or a drain. Some embodiments further comprise: a waste receptacle coupled to the waste drain conduit.
  • the gas conduit is configured to function at atmospheric pressure.
  • the apparatus is configured to maintain the gas conduit at atmospheric pressure.
  • Some embodiments further comprise a pump coupled to the disinfectant supply conduit and configured to pump a liquid between the reservoir and the basin.
  • the pump is configured to pump the liquid from the reservoir to the basin.
  • the reservoir is disposed at a lower elevation than the basin.
  • the gas conduit is coupled to the basin at an elevation greater than the elevation at which the disinfectant supply conduit is coupled to the basin.
  • Some embodiments further comprise: a valve coupled to the gas conduit and configured to be actuated to substantially prevent liquid communication between the basin and at least a portion of the gas conduit.
  • the gas conduit is coupled to the lid.
  • the lid is configured to be coupled to the top of the basin.
  • Some embodiments further comprise: a second basin having a second body and a second lid, the body configured to receive an endoscope such that the endoscope can be submersed in liquid with a headspace in the basin above the liquid, the second lid configured to be coupled to the second body to provide a substantially air-tight seal between the second lid and the second basin; a second reservoir with a top, the second reservoir configured to receive a liquid with a headspace between the liquid and the top; a second disinfectant supply conduit coupled to the second basin and to the second reservoir, and configured to communicate liquid from the second reservoir to the second basin; and a second gas conduit coupled to the second basin and to the second reservoir, the second gas conduit configured to communicate gas between the headspace of the second basin and the headspace of the second reservoir.
  • Some embodiments further comprise: a second basin configured to receive an endoscope such that the endoscope can be submersed in liquid with a headspace in the basin above the liquid; a second lid configured to be coupled to the second basin to provide a substantially air-tight seal between the second lid and the second basin; a second disinfectant supply conduit coupled to the second basin, and configured to communicate liquid from the reservoir to the second basin; and a second gas conduit coupled to the second basin and to at least one of the first basin and the reservoir, the second gas conduit configured to communicate gas between the headspace of the second basin and at least one of the headspace of the reservoir and the headspace of the first basin.
  • the disinfectant supply conduit is in direct fluid communication with the basin and the reservoir; and/or the gas conduit is in direct fluid communication with the basin and the reservoir.
  • At least one of the basin and the lid include an opening configured such that a tube of an irrigator can extend through the opening while connected to at least one channel of an endoscope in the basin for supplying disinfectant solution or rinse water to the at least one channel of the endoscope, the opening configured to substantially prevent fluid communication through the opening around the tube of the irrigator.
  • the apparatus is configured such that if the lid is coupled to the body of the basin, the apparatus substantially prevents gas from escaping to the surrounding atmosphere.
  • Some embodiments of the present methods for disinfecting and/or rinsing an endoscope comprise using an embodiment of the present apparatuses to disinfect one or more endoscopes.
  • Some embodiments of the present methods for disinfecting and/or rinsing an endoscope comprise: disposing an endoscope in a basin; coupling a lid to a body of a basin such that a substantially airtight seal is provided between the lid and the body; and transferring disinfectant solution from a reservoir to the basin through a disinfectant supply conduit such that the endoscope is submersed in the disinfectant solution, and a headspace is provided between the disinfectant solution and the lid; where the reservoir includes a top, a headspace is provided between any disinfectant solution remaining in the reservoir and the top of the reservoir, and the headspace of the basin is in fluid communication with the headspace in the reservoir through a gas conduit.
  • transferring is not electrically powered.
  • Some embodiments further comprise: transferring the disinfectant solution from the basin to the reservoir. Some embodiments further comprise: introducing water into the basin. In some embodiments, the basin is substantially filled with water. In some embodiments, the gas conduit is coupled to the lid. In some embodiments, a gas valve is disposed in the gas conduit and configured to be actuated to substantially prevent liquid communication between the basin and at least a portion of the gas conduit, and the method further comprises: closing the gas valve when the basin is substantially full of water.
  • Some embodiments of the present devices for disinfecting at least one endoscope comprise: (a) a basin, for receiving the endoscope to be disinfected, with a capacity sufficient to contain the endoscope such that the endoscope can be completely submerged in a liquid and a headspace can be maintained above the liquid within the basin; (b) a basin lid with an air-tight seal, for providing an air-tight closure above the basin; (c) a sealable reservoir, for containing a disinfectant solution; (d) a disinfectant supply tube connected to the basin and to the reservoir, for supplying the basin with the disinfectant solution; (e) a disinfectant supply pump connected in-line with the disinfectant supply tube, for pumping the disinfectant solution from the reservoir to the basin; (f) a water supply tube connected to the basin and to a water source, for supplying rinse water to the basin; (g) one or more drain tubes connected to the basin and to: (1) the reservoir, for returning the disinfectant solution to the reservoir, or (2) a waste container or drain
  • Some embodiments further comprise: a self-sealing opening in the lid or basin, through which the tube(s) of an all-channel irrigator can pass and connect to at least one channel of the endoscope inside the basin and connect to a syringe or to an irrigating pump outside the basin, for supplying disinfectant solution or rinse water to the channel of the endoscope.
  • any embodiment of any of the present apparatuses and methods can consist of or consist essentially of - rather than comprise/include/contain/have - any of the described steps, elements, and/or features.
  • the term “consisting of or “consisting essentially of” can be substituted for any of the open-ended linking verbs recited above, in order to change the scope of a given claim from what it would otherwise be using the open-ended linking verb.
  • FIG. 1 a perspective view of an embodiment of the present apparatuses.
  • FIG. 2 is a block diagram of a slight variation of the embodiment of FIG. 1.
  • FIG. 3 is a block diagram of a second embodiment of the present apparatuses.
  • Coupled is defined as connected, although not necessarily directly, and not necessarily mechanically; two items that are “coupled” may be unitary with each other unless the context explicitly requires that they be separate structures.
  • the terms “a” and “an” are defined as one or more unless this disclosure explicitly requires otherwise.
  • the term “substantially” is defined as largely but not necessarily wholly what is specified (and includes what is specified; e.g., substantially 90 degrees includes 90 degrees and substantially parallel includes parallel), as understood by a person of ordinary skill in the art. In any disclosed embodiment, the terms “substantially,” “approximately,” and “about” may be substituted with "within [a percentage] of what is specified, where the percentage includes .1, 1, 5, and 10 percent.
  • a method that "comprises,” “has,” “includes” or “contains” one or more steps possesses those one or more steps, but is not limited to possessing only those one or more steps.
  • a device or system that is configured in a certain way is configured in at least that way, but it can also be configured in other ways than those specifically described.
  • FIGS. 1 and 2 shown therein and designated by the reference numeral 10 are two variations of a first embodiment of the present apparatuses for disinfecting and/or rinsing endoscopes, which for brevity, will be described together.
  • a disinfectant that can be used is in the present apparatuses and methods is an aldehyde-based high-level disinfectant solution, such as ALDAHOL® High-Level Disinfectant Solution available from Healthpoint, Ltd.
  • apparatus 10 comprises a basin 14 having a body 16 and a lid 18, a reservoir 22 (e.g., a disinfectant reservoir), a disinfectant supply conduit 26, and a gas conduit 30 (e.g., air-return conduit).
  • reservoir 22 is disposed at a lower elevation than basin 14.
  • basin 14 and/or lid 18 can be transparent (e.g., plastic), such that, for example, liquid levels in the basin can be monitored, and/or fluid and air expelled from the channels of the endoscope can be observed, by operating personnel.
  • Basin 14 can comprise any material suitable for holding a disinfectant solution.
  • basin 14 e.g., body 16
  • an endoscope 34 e.g., one, two, three, or more endoscopes
  • basin 14 is sized such that an endoscope can be submersed in about two (2) gallons of liquid.
  • lid 18 is configured to be coupled (e.g., pivotally coupled via a hinge or hinges, as shown; removably coupled via clamps or the like; etc.) to basin 14 is configured to provide a substantially air-tight seal between lid 18 and body 16 (e.g., to be coupled to the top of the basin (e.g., and to the top of body 16, as shown)).
  • basin 14 is configured to be sealable to substantially prevent the disinfectant solution fumes from escaping into the air outside the device.
  • reservoir 22 includes a top 46 (e.g., a fixed or removable top), and is configured to receive a liquid 50 (which may be substantially similar and/or the same as liquid 38) with a headspace 54 between liquid 50 and top 46.
  • disinfectant supply conduit 26 is coupled to basin 14 and to reservoir 22, and configured to communicate liquid from reservoir 22 to basin 14 (e.g., is in direct fluid communication with basin 14, as shown).
  • gas conduit 30 is coupled to basin 14 and reservoir 22, and configured to communicate gas (e.g., air, fumes, etc.) between headspace 42 of basin 14 and headspace 54 of reservoir 22 (e.g., is in direct fluid communication with basin 14 and/or reservoir 22, as shown).
  • gas conduit 30 is configured to function at atmospheric pressure.
  • apparatus 10 is configured to maintain gas conduit 30 substantially at atmospheric pressure (e.g., as disinfectant solution is introduced into basin 14, air or other gas in basin 14 is allowed to flow through gas conduit 30 to reservoir 22.
  • Reservoir 22 may, in some embodiments, be disposable and/or replaceable.
  • a disinfectant shipping container e.g., container in which the disinfectant is shipped
  • reservoir 22 is configured to be coupled to conduits 26 and 30 such that liquid (e.g., and gas) is substantially prevented from escaping from reservoir 22 except through conduits 26 and 30.
  • reservoir 22 has a rectangular shape.
  • apparatus 10 further comprises a water supply conduit 58 coupled to basin 14, and configured to be coupled to a water source such as a water tap 60 (or a water tank, etc.), and to communicate water to basin 14.
  • apparatus 10 further comprises a water tank coupled to water supply conduit 58.
  • apparatus 10 further comprises a filter 62 (e.g., a bacterial filter) coupled to water supply conduit 58 such that water from a water supply coupled to water supply conduit 58 will pass through the filter before being communicated to basin 14.
  • the water source can provide purified and or substantially bacteria-free water.
  • apparatus 10 can further comprise a disinfectant drain conduit 66 coupled to basin 14 and reservoir 22, and configured to communicate liquid (e.g., disinfectant) from basin 14 to reservoir 22.
  • liquid e.g., disinfectant
  • disinfectant solution can be repeatedly used to disinfect endoscopes and returned to reservoir 22 until the disinfectant solution is exhausted (e.g., reaches its minimum recommended concentration (MRC)).
  • reservoir 22 includes a removable dipstick configured to be removed with a small sample of disinfecting solution (e.g., a few drops) for testing the concentration of the disinfectant solution (e.g., with a paper test strip or the like).
  • disinfectant drain conduit 66 and disinfectant supply conduit 26 are unitary (e.g., a single conduit is configured to communicate disinfectant or other liquid between basin 14 and reservoir 22.
  • apparatus 10 can further comprise a disinfectant drain valve 70 coupled to disinfectant drain conduit and configured to be actuated (e.g., closed) to substantially prevent liquid (e.g., and gas) communication between basin 1 and reservoir 22.
  • a disinfectant drain valve 70 coupled to disinfectant drain conduit and configured to be actuated (e.g., closed) to substantially prevent liquid (e.g., and gas) communication between basin 1 and reservoir 22.
  • valve 70 is disposed closer to basin 14 than to reservoir 22 (e.g., at or in contact with basin 14).
  • apparatus 10 further comprises a waste drain conduit 74 coupled to basin 14, and configured to communicate liquid (e.g., rinse water) out of basin 14 (e.g., to a drain or a waste receptacle).
  • the apparatus further comprises a waste receptacle configured to receive waste from waste drain conduit 74.
  • apparatus 10 further comprises a waste drain valve 78 coupled to waste drain conduit 74 and configured to be actuated (e.g., closed) to substantially prevent liquid communication out of basin 14 through waste drain conduit 74.
  • valve 78 is disposed closer to basin 14 than to the opposing end of waste drain conduit 74 (e.g., at or in contact with basin 14).
  • waste drain conduit 74 is configured to permit wastewater to be forced out of basin 14 by gravity.
  • the apparatus further comprises a waste pump coupled to the waste drain conduit 74, and configured to draw waste liquid (e.g., waste water) from the basin.
  • waste liquid e.g., waste water
  • disinfectant drain conduit 66 and waste drain conduit 74 are both coupled to basin 14 through a single port by way of a diverter valve (not shown) that is configured to direct liquid from basin 14 to either of disinfectant drain conduit 66 or waste drain conduit 74.
  • apparatus 10 further comprises a pump 82 coupled to disinfectant supply conduit 26, and configured to pump a liquid (e.g., disinfectant solution) between reservoir 22 and basin 14 (e.g., from reservoir 22 to basin 14 and/or from basin 14 to reservoir 22).
  • Pump 82 can comprise, for example, a self-priming electric pump (e.g., a rotary pump, a peristaltic pump, etc.), a hand pump (e.g., a hand-crank rotary pump, a squeeze bulb, etc.), and or any other pump enabling apparatus 10 to function as described in this disclosure.
  • pump 82 can be a bi-directional pump configured to be capable of pumping disinfectant from basin 14 to reservoir 22.
  • gas conduit 30 is coupled to basin 14 at an elevation greater than the elevation at which disinfectant supply conduit 26 is coupled to basin 14.
  • gas conduit 30 can be coupled to body 16; or, as shown in FIG. 2, gas conduit 30 can be coupled to lid 18.
  • apparatus 10 also comprises a valve 86 coupled to gas conduit 30, and configured to be actuated (e.g., closed) to substantially prevent liquid (e.g., and gas) communication between basin 14 and at least a portion of gas conduit 30.
  • valve 86 is disposed closer to basin 14 than to reservoir 22 (e.g., at or in contact with basin 14).
  • valve 86 can be coupled to lid 18.
  • apparatus 10 further comprises a frame 90 coupled to and/or configured to support basin 14, reservoir 22, and pump 82 in fixed relation to one another.
  • frame 90 includes a plurality of wheels or casters 92 configured to permit apparatus to be rolled across a surface.
  • the frame can be stationary.
  • frame 90 includes three shelves, with the basin disposed at the height of the top shelf, the pump disposed on the middle shelf, and the reservoir disposed on the bottom shelf.
  • the apparatus is configured to be manually operated by actuating the pumps and various valves (e.g., apparatus 10 does not include a controller configured to sequence the function of the valves and pump to permit the apparatus to operate or be operated as described in this disclosure.
  • apparatus 10 does not include a controller configured to sequence the function of the valves and pump to permit the apparatus to operate or be operated as described in this disclosure.
  • apparatus 10 further comprises a fitting 94 (e.g., grommet or the like) with an opening configured such that a tube of an irrigator (e.g., an all- channel irrigator 98 for an endoscope—such as, for example, an OLYMPUS CW-3 All Channel Irrigator Set available from: Zoi Surgical, Inc., Chesterland, Ohio, USA) can extend through the opening while connected to at least one channel of an endoscope in the basin for supplying disinfectant solution or rinse water to the at least one channel of the endoscope, the opening configured to substantially prevent fluid communication through the opening around the tube of the irrigator.
  • a tube of an irrigator e.g., an all- channel irrigator 98 for an endoscope— such as, for example, an OLYMPUS CW-3 All Channel Irrigator Set available from: Zoi Surgical, Inc., Chesterland, Ohio, USA
  • an OLYMPUS CW-3 All Channel Irrigator Set available from: Zoi Surgical, Inc
  • Fitting 94 can be self-sealing, such that, for example, if an irrigator does not pass through fitting 94, gases are substantially prevented from escaping through fitting 94; and if an irrigator does pass through fitting 94, gases are substantially prevented from escaping through fitting 94 (e.g., between the tube of the irrigator and the fitting).
  • apparatus 10 further comprises a second basin 14' with a body 16' and a lid 18', a second reservoir 22', a second disinfectant supply conduit 26', and a second gas conduit 30', each of which can be substantially similar in function and/or construction to the corresponding components described above.
  • water supply conduit 58 and water supply conduit 58' are configured to be coupled to a common water supply such that the water supply can provide water to both water supply conduits 58 and 58'.
  • apparatus 10 can include more than two of any of the foregoing components.
  • the various conduits (or tubes) described in this disclose can comprise or be constructed of any material suitable for contact with disinfectant solutions, and may be rigid and/or flexible.
  • Some embodiments of the present methods for disinfecting and/or rinsing an endoscope comprise: disposing an endoscope (e.g., 34) in a basin (e.g., 14, 14'); coupling a lid (e.g., 18, 18') to a body (e.g., 16, 16') of the basin such that a substantially airtight seal is provided between the lid and the body; and transferring disinfectant solution (e.g., 36, 36', 50, 50') from a reservoir (e.g., 22, 22') to the basin through a disinfectant supply conduit (e.g., 26, 26') such that the endoscope is submersed in the disinfectant solution, and a headspace (e.g., 42, 42') is provided between the disinfectant solution and the lid.
  • a disinfectant supply conduit e.g., 26, 26'
  • the reservoir includes a top (e.g., 46, 46'), a headspace (54, 54') is provided between any disinfectant solution remaining in the reservoir and the top of the reservoir, and the headspace of the basin is in fluid communication with the headspace in the reservoir through a gas conduit (e.g., 30, 30'). Displaced air in the headspace of the basin is permitted to flow to the headspace of the reservoir through the gas conduit in a substantially closed circuit that maintains substantially equal pressure between the disinfectant reservoir and the basin, and substantially prevents escape of disinfectant fumes into the air outside the device.
  • a top e.g., 46, 46'
  • a headspace 54, 54'
  • the headspace of the basin is in fluid communication with the headspace in the reservoir through a gas conduit (e.g., 30, 30'). Displaced air in the headspace of the basin is permitted to flow to the headspace of the reservoir through the gas conduit in a substantially closed circuit that maintains substantially equal pressure between the disinfectant reservoir and the basin, and substantially prevents escape
  • the various conduits can be coupled to the pump(s), basin(s), reservoir(s), and or other components in substantially air-tight fashion, such that, for example, gas (e.g., fumes) can be substantially prevented from escaping apparatus 10.
  • gas e.g., fumes
  • transferring the disinfectant solution is not electrically powered (e.g., is done with a manually-actuated pump or siphon).
  • Some embodiments further comprise coupling an irrigator to the endoscope such that the irrigator extends out of the basin (e.g., through fitting 94, 94'). Some embodiments further comprising introducing disinfectant solution, water, and or air into the endoscope through the irrigator (e.g., from a pump, syringe, or other source).
  • the endoscope can be kept submersed in the disinfectant solution for a specified amount of time.
  • a timer can be set (e.g., manually) for 10 or 20 minutes, or any other suitable time period (e.g., an exposure time directed by the instructions of the disinfectant).
  • Some embodiments further comprise transferring the disinfectant solution from the basin to the reservoir. For example, after the exposure time has elapsed, the disinfectant solution can be drained from the basin back into the disinfectant reservoir through a disinfectant drain conduit (e.g., 60, 60'), and a disinfectant drain valve can be closed (e.g., 70, 70'). Once the disinfectant solution is exhausted, i.e. after the disinfectant solution reaches its minimum recommended concentration (MRC), then the expired solution can be discarded. If the reservoir is disposable, the expired solution and the reservoir can be disposed of.
  • MRC minimum recommended concentration
  • Some embodiments further comprise introducing water into the basin and/or into the endoscope (e.g., via irrigator 98).
  • the basin is substantially filled with water (e.g., such that headspace 42 or 42' is substantially eliminated).
  • Some embodiments further comprise closing the gas valve (e.g., 86, 86') when the basin is substantially full of water (e.g., to minimize the amount of gas or fumes remaining in basin 14).
  • the rinse water can then be drained from the basin through a waste drain conduit (e.g., 74, 74'), and diverted to a waste receptacle or a drain. In some embodiments, this rinsing procedure is repeated two, three, or more times. After the final rinse, the lid can be opened, and the endoscope(s) is removed and used immediately or hung up to drip dry prior to use.
  • Apparatus 10' comprises components that can be substantially similar to the correspondingly numbered components described above. As such, the differences between apparatus 10 and apparatus 10' are primarily described here.
  • Apparatus 10' comprises first and second basins 14 and 14' coupled to a single pump 82 and reservoir 22 via a branched disinfectant supply conduit 26

Abstract

Systems and methods for disinfection and/or water rinsing of endoscopes in which disinfectant fumes can be contained during use (e.g., to limit operator exposure to disinfectants and fumes).

Description

DEVICE FOR DISINFECTING AND/OR RINSING ENDOSCOPES
WITH LIMITED ESCAPE OF FUMES
DESCRIPTION
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to U.S. Provisional Patent Application No.
61/388,210, filed September 30, 2010, which is incorporated by reference in its entirety.
BACKGROUND
1. Field of the Invention
[0002] The present invention relates generally to disinfection and/or rinsing; and more particularly, but not by way of limitation, to high-level disinfection and/or rinsing of endoscopes.
2. Description of Related Art
[0003] Endoscopes (e.g., heat-sensitive, semi-critical, and/or flexible fiberoptic endoscopes such as gastroscopes, colonoscopes, bronchoscopes, laryngoscopes, and cystoscopes) often must be thoroughly cleaned, rinsed to remove the cleaning agents, disinfected with high level disinfectants, and rinsed to remove the disinfectants, before use with each patient. Vapors from high level disinfectants such as alkaline glutaraldehyde, glutaraldehyde plus isopropanol, ortho-phthalaldehyde, and peracetic acid solutions may irritate and sensitize the skin, eyes, and mucous membranes of the medical personnel who work with these disinfectants in open basins to reprocess the flexible endoscopes.
[0004] Automatic endoscope reprocessing machines (AER's) have been developed to hold the flexible endoscopes in a basin, and hold the high level disinfectant solutions in a separate reservoir. An endoscope may be placed into the basin of an AER, where disinfectant solutions and subsequently rinse water can be automatically transferred in and out of the basin. The endoscope may also be connected to tubing to automatically flush the disinfectants and rinse water through the internal air, water, and working (biopsy) channels of the endoscopes. Operation of an AER is typically controlled and performed automatically by a programmable CPU. The disinfectant reservoir and the basin of the AER may be enclosed, and may sufficiently contain the vapors of the high level disinfectant in the reservoir and basin of the AER, to protect the workers from the vapors. However, such AER machines are generally expensive, and can cost from $30,000 to $40,000. Many are also limited to disinfecting and rinsing at most two flexible endoscopes at the same time, and often require about 30 to 40 minutes per reprocessing cycle.
[00051 Because of the expense of known AER machines, and the abundance of unskilled labor, flexible endoscopes world-wide may be manually disinfected between uses with each patient. The manual disinfection process is generally similar to the automated process, i.e., clean, rinse, disinfect, rinse, except the manual process is often performed by a person using basins of disinfectant and rinse water, often exposed and open to air. High level disinfectant solution may be held in a basin into which the endoscope is placed. Tubing is generally attached to the flexible endoscope channels and to a syringe or pump. The operator may work over the disinfectant basin and the endoscope, and the operator may pump the disinfectant through the channels of the endoscope. The air space immediately above the disinfectant solution in the basin may be in the operator's breathing zone, and unless the operator is wearing a breathing mask (a gas mask) that covers the eyes, nose, and mouth, the operator may come into contact with the vapors of the disinfectant. Even if the operator is wearing a breathing mask, vapors of the disinfectant solution may escape into the air of the reprocessing space such as a chemical fume hood, or the air of the reprocessing room and can irritate exposed skin or other personnel in the area.
[0006] After the endoscope has been exposed to the high level disinfectant, then the endoscope is generally transferred to another basin holding fresh rinse water, and may be manually flushed with the rinse water. This rinsing procedure is generally repeated three times with fresh rinse water each time to dilute the chemicals of the high level disinfectant to the level of no observable toxic effect. This process of transfer and rinsing of the endoscope again has the potential to release fumes of the disinfectant to the surrounding air.
[0007] Glutaraldehyde is a high level disinfectant with a long history of use, and glutaraldehyde plus 20% w/w isopropanol is another disinfectant that is generally more antimicrobially effective than Glutaraldehyde. Both of these disinfectant solutions may cause irritation and sensitization of personnel caused by the fumes/vapors of glutaraldehyde (e.g., fumes of glutaraldehyde released during manual disinfection of endoscopes). Solutions of ortho-phthalaldehyde (OP A) are increasingly used because the relatively low vapor pressure of OPA reduces the vapors that can escape from solutions of OP A. However, OPA is generally not considered to be a sterilant, and may not kill at least one common spore-forming bacteria: Bacillus subtilis. These surviving bacteria may initiate formation of biofilms within endoscopes, after which the endoscope may be difficult or impossible to disinfect. OPA is also generally considered to be a potent allergen, and cases of anaphylactic shock have been reported in scientific literature believed by some to be due to use and re-use of endoscopes disinfected with OPA. Labels of OPA solutions generally carry a warning against the use of OPA with certain endoscopes (e.g., cystoscopes, used to monitor bladder cancer patients). OPA has relatively low solubility in water, and one recent publication demonstrates that OPA adsorbs onto endoscope surfaces and may not be adequately rinsed away even with excessive numbers of rinses.
[0008] Examples of apparatuses for disinfecting and/or rinsing endoscopes are disclosed in: (l) U.S. Patent No. 3,963,438; (2) U.S. Patent No. 4,391,287; (3) U.S. Patent No. 4,732,187; (4) U.S. Patent No. 4,763,678; (5) U.S. Patent No. 5,494,637; (6) U.S. Patent No. 5,882,589; and (7) U.S. Patent No. 6,361,751.
SUMMARY
[0009] The present disclosure includes embodiments of systems and methods for disinfecting and/or rinsing endoscopes (e.g., while reducing user exposure to fumes).
[0010] Some embodiments of the present apparatuses for disinfecting and/or rinsing an endoscope comprise: a basin including a body and a lid, the body configured to receive an endoscope such that the endoscope can be submersed in liquid with a headspace in the basin above the liquid, the lid configured to be coupled to the basin to provide a substantially airtight seal between the lid and the body; a reservoir with a top, the reservoir configured to receive a liquid with a headspace between the liquid and the top; a disinfectant supply conduit coupled to the basin and to the reservoir, and configured to communicate liquid from the reservoir to the basin; and a gas conduit coupled to the basin and to the reservoir, the gas conduit configured to communicate gas between the headspace of the basin and the headspace of the reservoir.
[0011] Some embodiments further comprise: a water supply conduit coupled to the basin, and configured to be coupled to a water source to communicate water to the basin. Some embodiments further comprise: a filter coupled to the water supply conduit. Some embodiments further comprise: a disinfectant drain conduit coupled to the basin and to the reservoir, and configured to communicate liquid from the basin to the reservoir. Some embodiments further comprise: a disinfectant drain valve coupled to the disinfectant drain conduit and configured to be actuated to substantially prevent liquid communication between the basin and the reservoir. Some embodiments comprise a waste drain conduit coupled to the basin, and configured to communicate liquid out of the basin. Some embodiments further comprise: a waste drain valve coupled to the waste drain conduit and configured to be actuated to substantially prevent liquid communication out of the basin through the waste drain conduit. In some embodiments, the waste drain conduit is configured to communicate waste from the basin to a waste receptacle or a drain. Some embodiments further comprise: a waste receptacle coupled to the waste drain conduit.
[0012] In some embodiments, the gas conduit is configured to function at atmospheric pressure. In some embodiments, the apparatus is configured to maintain the gas conduit at atmospheric pressure. Some embodiments further comprise a pump coupled to the disinfectant supply conduit and configured to pump a liquid between the reservoir and the basin. In some embodiments, the pump is configured to pump the liquid from the reservoir to the basin. In some embodiments, the reservoir is disposed at a lower elevation than the basin. In some embodiments, the gas conduit is coupled to the basin at an elevation greater than the elevation at which the disinfectant supply conduit is coupled to the basin. Some embodiments further comprise: a valve coupled to the gas conduit and configured to be actuated to substantially prevent liquid communication between the basin and at least a portion of the gas conduit. In some embodiments, the gas conduit is coupled to the lid. In some embodiments, the lid is configured to be coupled to the top of the basin.
[0013] Some embodiments further comprise: a second basin having a second body and a second lid, the body configured to receive an endoscope such that the endoscope can be submersed in liquid with a headspace in the basin above the liquid, the second lid configured to be coupled to the second body to provide a substantially air-tight seal between the second lid and the second basin; a second reservoir with a top, the second reservoir configured to receive a liquid with a headspace between the liquid and the top; a second disinfectant supply conduit coupled to the second basin and to the second reservoir, and configured to communicate liquid from the second reservoir to the second basin; and a second gas conduit coupled to the second basin and to the second reservoir, the second gas conduit configured to communicate gas between the headspace of the second basin and the headspace of the second reservoir.
[0014] Some embodiments further comprise: a second basin configured to receive an endoscope such that the endoscope can be submersed in liquid with a headspace in the basin above the liquid; a second lid configured to be coupled to the second basin to provide a substantially air-tight seal between the second lid and the second basin; a second disinfectant supply conduit coupled to the second basin, and configured to communicate liquid from the reservoir to the second basin; and a second gas conduit coupled to the second basin and to at least one of the first basin and the reservoir, the second gas conduit configured to communicate gas between the headspace of the second basin and at least one of the headspace of the reservoir and the headspace of the first basin.
[0015] In some embodiments, the disinfectant supply conduit is in direct fluid communication with the basin and the reservoir; and/or the gas conduit is in direct fluid communication with the basin and the reservoir.
[0016] In some embodiments, at least one of the basin and the lid include an opening configured such that a tube of an irrigator can extend through the opening while connected to at least one channel of an endoscope in the basin for supplying disinfectant solution or rinse water to the at least one channel of the endoscope, the opening configured to substantially prevent fluid communication through the opening around the tube of the irrigator.
[0017] In some embodiments, the apparatus is configured such that if the lid is coupled to the body of the basin, the apparatus substantially prevents gas from escaping to the surrounding atmosphere.
[0018] Some embodiments of the present methods for disinfecting and/or rinsing an endoscope comprise using an embodiment of the present apparatuses to disinfect one or more endoscopes.
[0019] Some embodiments of the present methods for disinfecting and/or rinsing an endoscope comprise: disposing an endoscope in a basin; coupling a lid to a body of a basin such that a substantially airtight seal is provided between the lid and the body; and transferring disinfectant solution from a reservoir to the basin through a disinfectant supply conduit such that the endoscope is submersed in the disinfectant solution, and a headspace is provided between the disinfectant solution and the lid; where the reservoir includes a top, a headspace is provided between any disinfectant solution remaining in the reservoir and the top of the reservoir, and the headspace of the basin is in fluid communication with the headspace in the reservoir through a gas conduit. In some embodiments, transferring is not electrically powered. Some embodiments further comprise: transferring the disinfectant solution from the basin to the reservoir. Some embodiments further comprise: introducing water into the basin. In some embodiments, the basin is substantially filled with water. In some embodiments, the gas conduit is coupled to the lid. In some embodiments, a gas valve is disposed in the gas conduit and configured to be actuated to substantially prevent liquid communication between the basin and at least a portion of the gas conduit, and the method further comprises: closing the gas valve when the basin is substantially full of water.
[0020] Some embodiments of the present devices for disinfecting at least one endoscope comprise: (a) a basin, for receiving the endoscope to be disinfected, with a capacity sufficient to contain the endoscope such that the endoscope can be completely submerged in a liquid and a headspace can be maintained above the liquid within the basin; (b) a basin lid with an air-tight seal, for providing an air-tight closure above the basin; (c) a sealable reservoir, for containing a disinfectant solution; (d) a disinfectant supply tube connected to the basin and to the reservoir, for supplying the basin with the disinfectant solution; (e) a disinfectant supply pump connected in-line with the disinfectant supply tube, for pumping the disinfectant solution from the reservoir to the basin; (f) a water supply tube connected to the basin and to a water source, for supplying rinse water to the basin; (g) one or more drain tubes connected to the basin and to: (1) the reservoir, for returning the disinfectant solution to the reservoir, or (2) a waste container or drain, for disposing of the disinfectant solution or rinse water; and (h) an air vent tube in communication with the basin headspace and the reservoir headspace, for maintaining equal air pressure between the basin and the reservoir. Some embodiments further comprise: a self-sealing opening in the lid or basin, through which the tube(s) of an all-channel irrigator can pass and connect to at least one channel of the endoscope inside the basin and connect to a syringe or to an irrigating pump outside the basin, for supplying disinfectant solution or rinse water to the channel of the endoscope.
[0021] Any embodiment of any of the present apparatuses and methods can consist of or consist essentially of - rather than comprise/include/contain/have - any of the described steps, elements, and/or features. Thus, in any of the claims, the term "consisting of or "consisting essentially of can be substituted for any of the open-ended linking verbs recited above, in order to change the scope of a given claim from what it would otherwise be using the open-ended linking verb.
[0022] The feature or features of one embodiment may be applied to other embodiments, even though not described or illustrated, unless expressly prohibited by this disclosure or the nature of the embodiments.
[0023] Details associated with the embodiments described above and others are presented below. BRIEF DESCRIPTION OF THE DRAWINGS
[0024] The following drawings illustrate by way of example and not limitation. For the sake of brevity and clarity, every feature of a given structure is not always labeled in every figure in which that structure appears. Identical reference numbers do not necessarily indicate an identical structure. Rather, the same reference number may be used to indicate a similar feature or a feature with similar functionality, as may non-identical reference numbers. The figures are drawn to scale (unless otherwise noted), meaning the sizes of the depicted elements are accurate relative to each other for at least the embodiment depicted in the figures.
[0025] FIG. 1 a perspective view of an embodiment of the present apparatuses.
[0026] FIG. 2 is a block diagram of a slight variation of the embodiment of FIG. 1.
[0027] FIG. 3 is a block diagram of a second embodiment of the present apparatuses.
DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS
[0028] The term "coupled" is defined as connected, although not necessarily directly, and not necessarily mechanically; two items that are "coupled" may be unitary with each other unless the context explicitly requires that they be separate structures. The terms "a" and "an" are defined as one or more unless this disclosure explicitly requires otherwise. The term "substantially" is defined as largely but not necessarily wholly what is specified (and includes what is specified; e.g., substantially 90 degrees includes 90 degrees and substantially parallel includes parallel), as understood by a person of ordinary skill in the art. In any disclosed embodiment, the terms "substantially," "approximately," and "about" may be substituted with "within [a percentage] of what is specified, where the percentage includes .1, 1, 5, and 10 percent.
[0029] The terms "comprise" (and any form of comprise, such as "comprises" and "comprising"), "have" (and any form of have, such as "has" and "having"), "include" (and any form of include, such as "includes" and "including") and "contain" (and any form of contain, such as "contains" and "containing") are open-ended linking verbs. As a result, a device that "comprises," "has," "includes" or "contains" one or more elements possesses those one or more elements, but is not limited to possessing only those elements. Likewise, a method that "comprises," "has," "includes" or "contains" one or more steps possesses those one or more steps, but is not limited to possessing only those one or more steps. [0030] Further, a device or system that is configured in a certain way is configured in at least that way, but it can also be configured in other ways than those specifically described.
[0031] Referring now to the drawings, and more particularly to FIGS. 1 and 2, shown therein and designated by the reference numeral 10 are two variations of a first embodiment of the present apparatuses for disinfecting and/or rinsing endoscopes, which for brevity, will be described together. One example of a disinfectant that can be used is in the present apparatuses and methods is an aldehyde-based high-level disinfectant solution, such as ALDAHOL® High-Level Disinfectant Solution available from Healthpoint, Ltd.
[0032] In the embodiment shown, apparatus 10 comprises a basin 14 having a body 16 and a lid 18, a reservoir 22 (e.g., a disinfectant reservoir), a disinfectant supply conduit 26, and a gas conduit 30 (e.g., air-return conduit). In the embodiment shown, reservoir 22 is disposed at a lower elevation than basin 14. In some embodiments basin 14 and/or lid 18 can be transparent (e.g., plastic), such that, for example, liquid levels in the basin can be monitored, and/or fluid and air expelled from the channels of the endoscope can be observed, by operating personnel. Basin 14 can comprise any material suitable for holding a disinfectant solution. In the embodiment shown, basin 14 (e.g., body 16) is configured to receive an (e.g., loosely coiled) endoscope 34 (e.g., one, two, three, or more endoscopes) such that the endoscope can be submersed in liquid 38 with a headspace 42 in basin 14 above the liquid (between liquid 38 and lid 18). In some embodiments, basin 14 is sized such that an endoscope can be submersed in about two (2) gallons of liquid. In the embodiment shown, lid 18 is configured to be coupled (e.g., pivotally coupled via a hinge or hinges, as shown; removably coupled via clamps or the like; etc.) to basin 14 is configured to provide a substantially air-tight seal between lid 18 and body 16 (e.g., to be coupled to the top of the basin (e.g., and to the top of body 16, as shown)). In the embodiment shown, basin 14 is configured to be sealable to substantially prevent the disinfectant solution fumes from escaping into the air outside the device.
[0033] In the embodiment shown, reservoir 22 includes a top 46 (e.g., a fixed or removable top), and is configured to receive a liquid 50 (which may be substantially similar and/or the same as liquid 38) with a headspace 54 between liquid 50 and top 46. In the embodiment shown, disinfectant supply conduit 26 is coupled to basin 14 and to reservoir 22, and configured to communicate liquid from reservoir 22 to basin 14 (e.g., is in direct fluid communication with basin 14, as shown). In the embodiment shown, gas conduit 30 is coupled to basin 14 and reservoir 22, and configured to communicate gas (e.g., air, fumes, etc.) between headspace 42 of basin 14 and headspace 54 of reservoir 22 (e.g., is in direct fluid communication with basin 14 and/or reservoir 22, as shown). In the embodiment shown, gas conduit 30 is configured to function at atmospheric pressure. In the embodiment shown, apparatus 10 is configured to maintain gas conduit 30 substantially at atmospheric pressure (e.g., as disinfectant solution is introduced into basin 14, air or other gas in basin 14 is allowed to flow through gas conduit 30 to reservoir 22. Reservoir 22 may, in some embodiments, be disposable and/or replaceable. For example, a disinfectant shipping container (e.g., container in which the disinfectant is shipped) could also serve as the reservoir to eliminate the need to transfer disinfectant from the shipping container to a reservoir. In at least some embodiments, reservoir 22 is configured to be coupled to conduits 26 and 30 such that liquid (e.g., and gas) is substantially prevented from escaping from reservoir 22 except through conduits 26 and 30. In the embodiment shown, reservoir 22 has a rectangular shape.
[0034] In the embodiment shown, apparatus 10 further comprises a water supply conduit 58 coupled to basin 14, and configured to be coupled to a water source such as a water tap 60 (or a water tank, etc.), and to communicate water to basin 14. In some embodiments, apparatus 10 further comprises a water tank coupled to water supply conduit 58. In the embodiment shown, apparatus 10 further comprises a filter 62 (e.g., a bacterial filter) coupled to water supply conduit 58 such that water from a water supply coupled to water supply conduit 58 will pass through the filter before being communicated to basin 14. In some embodiments, the water source can provide purified and or substantially bacteria-free water.
[0035] As shown in FIG. 2, apparatus 10 can further comprise a disinfectant drain conduit 66 coupled to basin 14 and reservoir 22, and configured to communicate liquid (e.g., disinfectant) from basin 14 to reservoir 22. For example, disinfectant solution can be repeatedly used to disinfect endoscopes and returned to reservoir 22 until the disinfectant solution is exhausted (e.g., reaches its minimum recommended concentration (MRC)). In some embodiments, reservoir 22 includes a removable dipstick configured to be removed with a small sample of disinfecting solution (e.g., a few drops) for testing the concentration of the disinfectant solution (e.g., with a paper test strip or the like). In some embodiments, disinfectant drain conduit 66 and disinfectant supply conduit 26 are unitary (e.g., a single conduit is configured to communicate disinfectant or other liquid between basin 14 and reservoir 22. As also shown in FIG. 2, apparatus 10 can further comprise a disinfectant drain valve 70 coupled to disinfectant drain conduit and configured to be actuated (e.g., closed) to substantially prevent liquid (e.g., and gas) communication between basin 1 and reservoir 22. For example, in the embodiment shown, valve 70 is disposed closer to basin 14 than to reservoir 22 (e.g., at or in contact with basin 14).
[0036] In the embodiment shown, apparatus 10 further comprises a waste drain conduit 74 coupled to basin 14, and configured to communicate liquid (e.g., rinse water) out of basin 14 (e.g., to a drain or a waste receptacle). In some embodiments, the apparatus further comprises a waste receptacle configured to receive waste from waste drain conduit 74. In the embodiment shown, apparatus 10 further comprises a waste drain valve 78 coupled to waste drain conduit 74 and configured to be actuated (e.g., closed) to substantially prevent liquid communication out of basin 14 through waste drain conduit 74. For example, in the embodiment shown, valve 78 is disposed closer to basin 14 than to the opposing end of waste drain conduit 74 (e.g., at or in contact with basin 14). In the embodiment shown, waste drain conduit 74 is configured to permit wastewater to be forced out of basin 14 by gravity. In other embodiments, the apparatus further comprises a waste pump coupled to the waste drain conduit 74, and configured to draw waste liquid (e.g., waste water) from the basin. In some embodiments, disinfectant drain conduit 66 and waste drain conduit 74 are both coupled to basin 14 through a single port by way of a diverter valve (not shown) that is configured to direct liquid from basin 14 to either of disinfectant drain conduit 66 or waste drain conduit 74.
[0037] In the embodiment shown, apparatus 10 further comprises a pump 82 coupled to disinfectant supply conduit 26, and configured to pump a liquid (e.g., disinfectant solution) between reservoir 22 and basin 14 (e.g., from reservoir 22 to basin 14 and/or from basin 14 to reservoir 22). Pump 82 can comprise, for example, a self-priming electric pump (e.g., a rotary pump, a peristaltic pump, etc.), a hand pump (e.g., a hand-crank rotary pump, a squeeze bulb, etc.), and or any other pump enabling apparatus 10 to function as described in this disclosure. In some embodiments, such as those that do not include a disinfectant drain conduit 66, pump 82 can be a bi-directional pump configured to be capable of pumping disinfectant from basin 14 to reservoir 22.
[0038] In the embodiment shown, gas conduit 30 is coupled to basin 14 at an elevation greater than the elevation at which disinfectant supply conduit 26 is coupled to basin 14. For example, as shown in FIG. 1, gas conduit 30 can be coupled to body 16; or, as shown in FIG. 2, gas conduit 30 can be coupled to lid 18. In the embodiment shown, apparatus 10 also comprises a valve 86 coupled to gas conduit 30, and configured to be actuated (e.g., closed) to substantially prevent liquid (e.g., and gas) communication between basin 14 and at least a portion of gas conduit 30. For example, in the embodiment shown, valve 86 is disposed closer to basin 14 than to reservoir 22 (e.g., at or in contact with basin 14). For example, in the embodiment shown, valve 86 can be coupled to lid 18. [0039] In the embodiment shown, apparatus 10 further comprises a frame 90 coupled to and/or configured to support basin 14, reservoir 22, and pump 82 in fixed relation to one another. In the embodiment shown, frame 90 includes a plurality of wheels or casters 92 configured to permit apparatus to be rolled across a surface. In other embodiments, the frame can be stationary. In the embodiment shown, frame 90 includes three shelves, with the basin disposed at the height of the top shelf, the pump disposed on the middle shelf, and the reservoir disposed on the bottom shelf.
[0040] In the embodiment shown, the apparatus is configured to be manually operated by actuating the pumps and various valves (e.g., apparatus 10 does not include a controller configured to sequence the function of the valves and pump to permit the apparatus to operate or be operated as described in this disclosure.
[0041] In the embodiment shown, apparatus 10 further comprises a fitting 94 (e.g., grommet or the like) with an opening configured such that a tube of an irrigator (e.g., an all- channel irrigator 98 for an endoscope— such as, for example, an OLYMPUS CW-3 All Channel Irrigator Set available from: Zoi Surgical, Inc., Chesterland, Ohio, USA) can extend through the opening while connected to at least one channel of an endoscope in the basin for supplying disinfectant solution or rinse water to the at least one channel of the endoscope, the opening configured to substantially prevent fluid communication through the opening around the tube of the irrigator. Fitting 94 can be self-sealing, such that, for example, if an irrigator does not pass through fitting 94, gases are substantially prevented from escaping through fitting 94; and if an irrigator does pass through fitting 94, gases are substantially prevented from escaping through fitting 94 (e.g., between the tube of the irrigator and the fitting).
[0042] In the embodiment shown, apparatus 10 further comprises a second basin 14' with a body 16' and a lid 18', a second reservoir 22', a second disinfectant supply conduit 26', and a second gas conduit 30', each of which can be substantially similar in function and/or construction to the corresponding components described above. In the embodiment shown, water supply conduit 58 and water supply conduit 58' are configured to be coupled to a common water supply such that the water supply can provide water to both water supply conduits 58 and 58'. In other embodiments, apparatus 10 can include more than two of any of the foregoing components. The various conduits (or tubes) described in this disclose can comprise or be constructed of any material suitable for contact with disinfectant solutions, and may be rigid and/or flexible.
[0043] Some embodiments of the present methods for disinfecting and/or rinsing an endoscope comprise: disposing an endoscope (e.g., 34) in a basin (e.g., 14, 14'); coupling a lid (e.g., 18, 18') to a body (e.g., 16, 16') of the basin such that a substantially airtight seal is provided between the lid and the body; and transferring disinfectant solution (e.g., 36, 36', 50, 50') from a reservoir (e.g., 22, 22') to the basin through a disinfectant supply conduit (e.g., 26, 26') such that the endoscope is submersed in the disinfectant solution, and a headspace (e.g., 42, 42') is provided between the disinfectant solution and the lid. In some embodiments, the reservoir includes a top (e.g., 46, 46'), a headspace (54, 54') is provided between any disinfectant solution remaining in the reservoir and the top of the reservoir, and the headspace of the basin is in fluid communication with the headspace in the reservoir through a gas conduit (e.g., 30, 30'). Displaced air in the headspace of the basin is permitted to flow to the headspace of the reservoir through the gas conduit in a substantially closed circuit that maintains substantially equal pressure between the disinfectant reservoir and the basin, and substantially prevents escape of disinfectant fumes into the air outside the device. The various conduits can be coupled to the pump(s), basin(s), reservoir(s), and or other components in substantially air-tight fashion, such that, for example, gas (e.g., fumes) can be substantially prevented from escaping apparatus 10. In some embodiments, transferring the disinfectant solution is not electrically powered (e.g., is done with a manually-actuated pump or siphon).
[0044] Some embodiments further comprise coupling an irrigator to the endoscope such that the irrigator extends out of the basin (e.g., through fitting 94, 94'). Some embodiments further comprising introducing disinfectant solution, water, and or air into the endoscope through the irrigator (e.g., from a pump, syringe, or other source).
[0045] In some embodiments, the endoscope can be kept submersed in the disinfectant solution for a specified amount of time. For example, a timer can be set (e.g., manually) for 10 or 20 minutes, or any other suitable time period (e.g., an exposure time directed by the instructions of the disinfectant). [0046] Some embodiments further comprise transferring the disinfectant solution from the basin to the reservoir. For example, after the exposure time has elapsed, the disinfectant solution can be drained from the basin back into the disinfectant reservoir through a disinfectant drain conduit (e.g., 60, 60'), and a disinfectant drain valve can be closed (e.g., 70, 70'). Once the disinfectant solution is exhausted, i.e. after the disinfectant solution reaches its minimum recommended concentration (MRC), then the expired solution can be discarded. If the reservoir is disposable, the expired solution and the reservoir can be disposed of.
[0047] Some embodiments further comprise introducing water into the basin and/or into the endoscope (e.g., via irrigator 98). In some embodiments, the basin is substantially filled with water (e.g., such that headspace 42 or 42' is substantially eliminated). Some embodiments further comprise closing the gas valve (e.g., 86, 86') when the basin is substantially full of water (e.g., to minimize the amount of gas or fumes remaining in basin 14). The rinse water can then be drained from the basin through a waste drain conduit (e.g., 74, 74'), and diverted to a waste receptacle or a drain. In some embodiments, this rinsing procedure is repeated two, three, or more times. After the final rinse, the lid can be opened, and the endoscope(s) is removed and used immediately or hung up to drip dry prior to use.
[0048] Referring now to FIG. 3, shown therein and designated by the reference numeral 10' is a second embodiment of the present apparatuses. Apparatus 10' comprises components that can be substantially similar to the correspondingly numbered components described above. As such, the differences between apparatus 10 and apparatus 10' are primarily described here. Apparatus 10' comprises first and second basins 14 and 14' coupled to a single pump 82 and reservoir 22 via a branched disinfectant supply conduit 26
[0049] The above specification and examples provide a complete description of the structure and use of exemplary embodiments. Although certain embodiments have been described above with a certain degree of particularity, or with reference to one or more individual embodiments, those skilled in the art could make numerous alterations to the disclosed embodiments without departing from the scope of this invention. As such, the various illustrative embodiments of the present devices are not intended to be limited to the particular forms disclosed. Rather, they include all modifications and alternatives falling within the scope of the claims, and embodiments other than the one shown may include some or all of the features of the depicted embodiment. Further, where appropriate, aspects of any of the examples described above may be combined with aspects of any of the other examples described to form further examples having comparable or different properties and addressing the same or different problems. Similarly, it will be understood that the benefits and advantages described above may relate to one embodiment or may relate to several embodiments. [0050] The claims are not intended to include, and should not be interpreted to include, means-plus- or step-plus-function limitations, unless such a limitation is explicitly recited in a given claim using the phrase(s) "means for" or "step for," respectively.

Claims

1. An apparatus for disinfecting and/or rinsing an endoscope, the apparatus comprising: a basin including a body and a lid, the body configured to receive an endoscope such that the endoscope can be submersed in liquid with a headspace in the basin above the liquid, the lid configured to be coupled to the basin to provide a substantially air-tight seal between the lid and the body;
a reservoir with a top, the reservoir configured to receive a liquid with a headspace between the liquid and the top;
a disinfectant supply conduit coupled to the basin and to the reservoir, and configured to communicate liquid from the reservoir to the basin; and
a gas conduit coupled to the basin and to the reservoir, the gas conduit configured to communicate gas between the headspace of the basin and the headspace of the reservoir.
2. The apparatus of claim 1, further comprising:
a water supply conduit coupled to the basin, and configured to be coupled to a water source to communicate water to the basin.
3. The apparatus of claim 2, further comprising:
a filter coupled to the water supply conduit.
4. The apparatus of claim 1 , further comprising:
a disinfectant drain conduit coupled to the basin and to the reservoir, and configured to communicate liquid from the basin to the reservoir.
5. The apparatus of claim 4, further comprising:
a disinfectant drain valve coupled to the disinfectant drain conduit and configured to be actuated to substantially prevent liquid communication between the basin and the reservoir.
6. The apparatus of claim 1 , further comprising a waste drain conduit coupled to the basin, and configured to communicate liquid out of the basin.
7. The apparatus of claim 6, further comprising: a waste drain valve coupled to the waste drain conduit and configured to be actuated to substantially prevent liquid communication out of the basin through the waste drain conduit.
8. The apparatus of claim 6, where the waste drain conduit is configured to communicate waste from the basin to a waste receptacle or a drain.
9. The apparatus of claim 8, further comprising:
a waste receptacle coupled to the waste drain conduit.
10. The apparatus of claim 1, where the gas conduit is configured to function at atmospheric pressure.
11. The apparatus of claim 10, where the apparatus is configured to maintain the gas conduit at atmospheric pressure.
12. The apparatus of claim 2, further comprising:
a pump coupled to the disinfectant supply conduit and configured to pump a liquid between the reservoir and the basin.
13. The apparatus of claim 12, where the pump is configured to pump the liquid from the reservoir to the basin.
14. The apparatus of any of claims 1-13, where the reservoir is disposed at a lower elevation than the basin.
15. The apparatus of any of claims 1-13, where the gas conduit is coupled to the basin at an elevation greater than the elevation at which the disinfectant supply conduit is coupled to the basin.
16. The apparatus of claim 15, further comprising: a valve coupled to the gas conduit and configured to be actuated to substantially prevent liquid communication between the basin and at least a portion of the gas conduit.
17. The apparatus of claim 16, where the gas conduit is coupled to the lid.
18. The apparatus of claim 17, where the lid is configured to be coupled to the top of the basin.
19. The apparatus of any of claims 1-13, further comprising:
a second basin having a second body and a second lid, the body configured to receive an endoscope such that the endoscope can be submersed in liquid with a headspace in the basin above the liquid, the second lid configured to be coupled to the second body to provide a substantially air-tight seal between the second lid and the second basin;
a second reservoir with a top, the second reservoir configured to receive a liquid with a headspace between the liquid and the top;
a second disinfectant supply conduit coupled to the second basin and to the second reservoir, and configured to communicate liquid from the second reservoir to the second basin;
a second gas conduit coupled to the second basin and to the second reservoir, the second gas conduit configured to communicate gas between the headspace of the second basin and the headspace of the second reservoir.
20. The apparatus of any of claims 1-13, further comprising:
a second basin configured to receive an endoscope such that the endoscope can be submersed in liquid with a headspace in the basin above the liquid; a second lid configured to be coupled to the second basin to provide a substantially airtight seal between the second lid and the second basin;
a second disinfectant supply conduit coupled to the second basin, and configured to communicate liquid from the reservoir to the second basin;
a second gas conduit coupled to the second basin and to at least one of the first basin and the reservoir, the second gas conduit configured to communicate gas between the headspace of the second basin and at least one of the headspace of the reservoir and the headspace of the first basin.
21. The apparatus of any of claims 1-13, where:
the disinfectant supply conduit is in direct fluid communication with the basin and the reservoir; and/or
the gas conduit is in direct fluid communication with the basin and the reservoir.
22. The apparatus of any of claims 1-13, where at least one of the basin and the lid include an opening configured such that a tube of an irrigator can extend through the opening while connected to at least one channel of an endoscope in the basin for supplying disinfectant solution or rinse water to the at least one channel of the endoscope, the opening configured to substantially prevent fluid communication through the opening around the tube of the irrigator.
23. The apparatus of any of claims 1-13, where the apparatus is configured such that if the lid is coupled to the body of the basin, the apparatus substantially prevents gas from escaping to the surrounding atmosphere.
24. A method for disinfecting and/or rinsing an endoscope, the method comprising:
disposing an endoscope in a basin;
coupling a lid to a body of a basin such that a substantially airtight seal is provided between the lid and the body; and
transferring disinfectant solution from a reservoir to the basin through a disinfectant supply conduit such that the endoscope is submersed in the disinfectant solution, and a headspace is provided between the disinfectant solution and the lid;
where the reservoir includes a top, a headspace is provided between any disinfectant solution remaining in the reservoir and the top of the reservoir, and the headspace of the basin is in fluid communication with the headspace in the reservoir through a gas conduit.
25. The method of claim 24, where transferring is not electrically powered.
26. The method of claim 24, further comprising:
transferring the disinfectant solution from the basin to the reservoir.
27. The method of claim 26, further comprising:
introducing water into the basin.
28. The method of claim 27, where the basin is substantially filled with water.
29. The method of claim 28, where the gas conduit is coupled to the lid.
30. The method of claim 29, where a gas valve is disposed in the gas conduit and configured to be actuated to substantially prevent liquid communication between the basin and at least a portion of the gas conduit, the method further comprising:
closing the gas valve when the basin is substantially full of water.
31. A device for disinfecting at least one endoscope comprising:
(a) a basin, for receiving the endoscope to be disinfected, with a capacity sufficient to contain the endoscope such that the endoscope can be completely submerged in a liquid and a headspace can be maintained above the liquid within the basin;
(b) a basin lid with an air-tight seal, for providing an air-tight closure above the basin;
(c) a sealable reservoir, for containing a disinfectant solution;
(d) a disinfectant supply tube connected to the basin and to the reservoir, for supplying the basin with the disinfectant solution;
(e) a disinfectant supply pump connected in-line with the disinfectant supply tube, for pumping the disinfectant solution from the reservoir to the basin;
(f) a water supply tube connected to the basin and to a water source, for supplying rinse water to the basin;
(g) one or more drain tubes connected to the basin and to:
(1) the reservoir, for returning the disinfectant solution to the reservoir, or
(2) a waste container or drain, for disposing of the disinfectant solution or rinse water; and
(h) an air vent tube in communication with the basin headspace and the reservoir headspace, for maintaining equal air pressure between the basin and the reservoir.
32. The device of claim 31, further comprising a self-sealing opening in the lid or basin, through which the tube(s) of an all-channel irrigator can pass and connect to at least one channel of the endoscope inside the basin and connect to a syringe or to an irrigating pump outside the basin, for supplying disinfectant solution or rinse water to the channel of the endoscope.
PCT/US2011/054247 2010-09-30 2011-09-30 Device for disinfecting and/or rinsing endoscopes with limited escape of fumes WO2012044944A2 (en)

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AU2011308621A AU2011308621B2 (en) 2010-09-30 2011-09-30 Device for disinfecting and/or rinsing endoscopes with limited escape of fumes
CN201180054461.1A CN103347435B (en) 2010-09-30 2011-09-30 Sterilization and/or the device of rinsing endoscopes in the case of the limited escape of flue gas
KR1020137011076A KR101802382B1 (en) 2010-09-30 2011-09-30 Device for disinfecting and/or rinsing endoscopes with limited escape of fumes
NZ610039A NZ610039A (en) 2010-09-30 2011-09-30 Device for disinfecting and/or rinsing endoscopes with limited escape of fumes

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WO2012044944A3 (en) 2012-06-21
CN103347435B (en) 2016-08-10
AU2011308621B2 (en) 2016-04-28
NZ610039A (en) 2014-11-28

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