WO2020245658A2 - System and method for drying channels of medical instrument during cleaning - Google Patents

System and method for drying channels of medical instrument during cleaning Download PDF

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Publication number
WO2020245658A2
WO2020245658A2 PCT/IB2020/000449 IB2020000449W WO2020245658A2 WO 2020245658 A2 WO2020245658 A2 WO 2020245658A2 IB 2020000449 W IB2020000449 W IB 2020000449W WO 2020245658 A2 WO2020245658 A2 WO 2020245658A2
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Prior art keywords
channels
cycle
reprocessing
channel
drying
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PCT/IB2020/000449
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French (fr)
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WO2020245658A3 (en
Inventor
Sungwook Yang
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Asp Global Manufacturing Gmbh
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Publication of WO2020245658A2 publication Critical patent/WO2020245658A2/en
Publication of WO2020245658A3 publication Critical patent/WO2020245658A3/en

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Classifications

    • 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
    • A61L2/24Apparatus using programmed or automatic operation
    • 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
    • A61L2202/14Means for controlling sterilisation processes, data processing, presentation and storage means, e.g. sensors, controllers, programs
    • 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 below discussion relates to the reprocessing (i.e., decontamination) of endoscopes and other instruments that are used in medical procedures.
  • the below discussion relates to an apparatus and a method that may be used to reprocess a medical device such as an endoscope after the medical device has been used in a first medical procedure, such that the medical device may be safely used in a subsequent medical procedure.
  • a medical device such as an endoscope
  • the discussion will speak mainly in terms of an endoscope, it should be understood that the discussion may also equally apply to certain other medical devices.
  • An endoscope may have one or more working channels or lumens extending along at least a portion of the length of the endoscope. Such channels may be configured to provide a pathway for passage of other medical devices, etc., into an anatomical region within a patient. These channels may be difficult to clean and/or disinfect using certain primitive cleaning and/or disinfecting techniques.
  • the endoscope may be placed in a reprocessing system that is particularly configured to clean endoscopes, including the channels within endoscopes.
  • Such an endoscope reprocessing system may wash and disinfect the endoscope.
  • Such an endoscope reprocessing system may include a basin that is configured to receive the endoscope, with a pump that flows cleaning fluids over the exterior of the endoscope within the basin.
  • the system may also include ports that couple with the working channels of the endoscope and associated pumps that flow cleaning fluids through the working channels of the endoscope.
  • the process executed by such a dedicated endoscope reprocessing system may include a detergent washing cycle, followed by a rinsing cycle, followed by a sterilization or disinfection cycle, followed by another rinsing cycle.
  • the sterilization or disinfection cycle may employ disinfectant solution and water rinses.
  • the final rinsing cycle concludes with purging the endoscope channels with compressed air.
  • the process may further include an alcohol rinsing cycle in which the endoscope channels are filled with alcohol and then purged with compressed air to facilitate drying of the channels and thereby enhancing the decontamination effects of the process.
  • Some versions of reprocessing systems may provide just a single use of a certain volume of disinfectant solution, such that the used volume of disinfectant solution is disposed of after a single use of the volume of disinfectant solution upon completion of the disinfection cycle.
  • Some other versions of reprocessing systems may provide multiple uses of the same volume of disinfectant solution. Specifically, a volume of disinfectant solution may be recovered upon completion of a disinfection cycle and then reused for one or more subsequent disinfection cycles.
  • a concentration of the disinfectant may be monitored throughout the process of decontaminating an instrument.
  • a concentration level of the multi-use disinfectant may be monitored over the course of multiple disinfection cycles, and the used disinfectant may either re-used or discarded after a given disinfection cycle based at least in part on a remaining concentration of the used disinfectant.
  • Examples of versions of reprocessing systems that provide monitoring and re-use of disinfectant solution are disclosed in U.S. Pat. No. 8,246,909, entitled “Automated Endoscope Reprocessor Germicide Concentration Monitoring System and Method,” issued August 21, 2012, the disclosure of which is incorporated by reference herein; in U.S. Pat. No.
  • FIG. 1 depicts a front elevational view of an exemplary reprocessing system
  • FIG. 2 depicts a schematic diagram of the reprocessing system of FIG. 1, with only a single decontamination basin shown for clarity;
  • FIG. 3 depicts a cross-sectional side view of proximal and distal portions of an endoscope that may be decontaminated using the reprocessing system of FIG. 1;
  • FIG. 4 a depicts a flow diagram illustrating an exemplary reprocessing method useable by the reprocessing system of FIG. 1.
  • FIG. 5 depicts a flow diagram illustrating an exemplary user setup to add a channel drying cycle to the reprocessing method of FIG. 4;
  • FIG. 6 depicts a depicts a flow diagram illustrating an exemplary modification to the reprocessing method of FIG. 4, with the internal channels of a device undergoing a channel drying cycle and an extended channel drying cycle.
  • FIGS. 1-2 show an exemplary reprocessing system (2) that may be used to decontaminate endoscopes and other medical devices that include channels or lumens formed therethrough.
  • System (2) of this example generally includes a first station (10) and a second station (12). Stations (10, 12) are at least substantially similar in all respects to provide for the decontamination of two different medical devices simultaneously or in series.
  • First and second decontamination basins (14a, 14b) receive the contaminated devices. Each basin (14a, 14b) is selectively sealed by a respective lid (16a, 16b).
  • lids (16a, 16b) cooperate with respective basins (14a, 14b) to provide a microbe-blocking relationship to prevent the entrance of environmental microbes into basins (14a, 14b) during decontamination operations.
  • lids (16a, 16b) may include a microbe removal or HEPA air filter formed therein for venting.
  • a control system (20) includes one or more microcontrollers, such as a programmable logic controller (PLC), for controlling decontamination and user interface operations.
  • PLC programmable logic controller
  • a visual display (22) displays decontamination parameters and machine conditions for an operator, and at least one printer (24) prints a hard copy output of the decontamination parameters for a record to be filed or attached to the decontaminated device or its storage packaging. It should be understood that printer (24) is merely optional.
  • visual display (22) is combined with a touch screen input device.
  • a keypad and/or other user input feature is provided for input of decontamination process parameters and for machine control.
  • Other visual gauges (26) such as pressure meters and the like provide digital or analog output of decontamination or medical device leak testing data.
  • FIG. 2 diagrammatically illustrates just one decontamination station (10) of reprocessing system (2), but those skilled in the art will recognize that decontamination station (12) may be configured and operable just like decontamination station (10). It should also be understood that reprocessing system (2) may be provided with just one single decontamination station (10, 12) or more than two decontamination stations (10, 12).
  • Decontamination basin (14a) receives an endoscope (200) (see FIG. 3) or other medical device therein for decontamination.
  • Any internal channels of endoscope (200) are connected with flush conduits, such as flush lines (30).
  • Each flush line (30) is connected to an outlet of a corresponding pump (32), such that each flush line (30) has a dedicated pump (32) in this example.
  • Pumps (32) of the present example comprise peristaltic pumps that pump fluid, such as liquid and air, through the flush lines (30) and any internal channels of endoscope (200). Alternatively, any other suitable kind of pump(s) may be used.
  • pumps (32) can either draw liquid from basin (14a) through a filtered drain and a valve (SI); or draw decontaminated air from an air supply system (36) through a valve (S2).
  • Air supply system (36) of the present example includes a pump (38) and a microbe removal air filter (40) that filters microbes from an incoming air stream.
  • a pressure switch or sensor (42) is in fluid communication with each flush line (30) for sensing excessive pressure in the flush line. Any excessive pressure or lack of flow sensed may be indicative of a partial or complete blockage (e.g., by bodily tissue or dried bodily fluids) in an endoscope (200) channel to which the relevant flush line (30) is connected.
  • the isolation of each flush line (30) relative to the other flush lines (30) allows the particular blocked channel to be easily identified and isolated, depending upon which sensor (42) senses excessive pressure or lack of flow.
  • Basin (14a) is in fluid communication with a water source (50), such as a utility or tap water connection including hot and cold inlets, and a mixing valve (52) flowing into a break tank (56).
  • a microbe removal filter (54) such as a 0.2 pm or smaller absolute pore size filter, decontaminates the incoming water, which is delivered into break tank (56) through the air gap to prevent backflow.
  • a sensor (59) monitors liquid levels within basin (14a).
  • An optional water heater (53) can be provided if an appropriate source of hot water is not available.
  • the condition of filter (54) can be monitored by directly monitoring the flow rate of water therethrough or indirectly by monitoring the basin fill time using a float switch or the like. When the flow rate drops below a select threshold, this indicates a partially clogged filter element that requires replacement.
  • a basin drain (62) drains liquid from basin (14a) through an enlarged helical tube (64) into which elongated portions of endoscope (200) can be inserted.
  • Drain (62) is in fluid communication with a recirculation pump (70) and a drain pump (72).
  • Recirculation pump (70) recirculates liquid from basin drain (62) to a spray nozzle assembly (60), which sprays the liquid into basin (14a) and onto endoscope (200).
  • a coarse screen (71) and a fine screen (73) filter out particles in the recirculating fluid.
  • Drain pump (72) pumps liquid from basin drain (62) to a utility drain (74).
  • a level sensor (76) monitors the flow of liquid from pump (72) to utility drain (74).
  • Pumps (70, 72) can be simultaneously operated such that liquid is sprayed into basin (14a) while basin (14a) is being drained, to encourage the flow of residue out of basin (14a) and off of endoscope (200).
  • a single pump and a valve assembly could replace dual pumps (70, 72).
  • a flow sensor is used instead of pressure sensor (84), to measure fluid flow downstream of circulation pump (70).
  • Detergent solution (86) is metered into the flow downstream of circulation pump (70) via a metering pump (88).
  • a float switch (90) indicates the level of detergent (86) available.
  • Disinfectant (92) is metered into the flow upstream of circulation pump (70) via a metering pump (94).
  • disinfectant solution (92) may comprise an activated glutaraldehyde salutation, such as CIDEX® Activated Glutaraldehyde Solution by Advanced Sterilization Products of Irvine, California.
  • disinfectant solution (92) may comprise ortho- phthalaldehyde (OPA), such as CIDEX® ortho-phthalaldeyde solution by Advanced Sterilization Products of Irvine, California.
  • disinfectant solution (92) may comprise peracetic acid (PAA).
  • Some endoscopes (200) include a flexible outer housing or sheath surrounding the individual tubular members and the like that form the interior channels and other parts of endoscope (200).
  • This housing defines a closed interior space, which is isolated from patient tissues and fluids during medical procedures. It may be important that the sheath be maintained intact, without cuts or other holes that would allow contamination of the interior space beneath the sheath. Therefore, reprocessing system (2) of the present example includes means for testing the integrity of such a sheath.
  • an air pump e.g., pump (38) or another pump (110) pressurizes the interior space defined by the sheath of endoscope (200) through a conduit (112) and a valve (S5).
  • a HEPA or other microbe-removing filter removes microbes from the - Si - pressurizing air.
  • a pressure regulator 114 prevents accidental over pressurization of the sheath.
  • valve (S5) is closed and a pressure sensor (116) looks for a drop in pressure in conduit (112), which would indicate the escape of air through the sheath of endoscope (200).
  • a valve (S6) selectively vents conduit (112) and the sheath of endoscope (200) through an optional filter (118) when the testing procedure is complete.
  • An air buffer (120) smoothes out pulsation of pressure from air pump (110).
  • each station (10, 12) also contains a drip basin (130) and spill sensor (132) to alert the operator to potential leaks.
  • An alcohol supply (134), controlled by a valve (S3), can supply alcohol to channel pumps (32) after rinsing steps, to assist in removing water from channels (210, 212, 213, 214, 217, 218) of endoscope (200).
  • Flow rates in lines (30) can be monitored via channel pumps (32) and pressure sensors (42). If one of pressure sensors (42) detects too high a pressure, the associated pump (32) is deactivated. The flow rate of pump (32) and its activated duration time provide a reasonable indication of the flow rate in an associated line (30). These flow rates are monitored during the process to check for blockages in any of the channels of endoscope (200). Alternatively, the decay in the pressure from the time pump (32) cycles off can also be used to estimate the flow rate, with faster decay rates being associated with higher flow rates.
  • a metering tube (136) having a plurality of level indicating sensors (138) fluidly connects to the inputs of channel pumps (32).
  • a reference connection is provided at a low point in metering tube (136) and a plurality of sensors (138) are arranged vertically above the reference connection. By passing a current from the reference point through the fluid to sensors (138), it can be determined which sensors (138) are immersed and therefore determine the level within metering tube (136).
  • any other suitable components and techniques may be used to sense fluid levels.
  • channel pumps (32) draw exclusively from metering tube (136).
  • the amount of fluid being drawn can be very accurately determined based upon sensors (138).
  • the flow therethrough can be accurately determined based upon the time and the volume of fluid emptied from metering tube (136).
  • switches and sensors (42, 59, 76, 84, 90, 98, 114, 116, 132 136) provide input (I) to microcontroller (28), which controls the cleaning and/or disinfection cycles and other machine operations in accordance therewith.
  • microcontroller (28) includes outputs (O) that are operatively connected to pumps (32, 38, 70, 72, 88, 94, 100, 110), valves (SI, S2, S3, S5, S6, S7), and heater (80) to control these devices for effective cleaning and/or disinfection cycles and other operations.
  • endoscope (200) has a head part (202).
  • Head part (202) includes openings (204, 206) formed therein.
  • an air/water valve (not shown) and a suction valve (not shown) are arranged in openings (204, 206).
  • a flexible shaft (208) is attached to head part (202).
  • a combined air/water channel (210) and a combined suction/biopsy channel (212) are accommodated in shaft (208).
  • a separate air channel (213) and water channel (214) are also arranged in head part (202) and merge into air/water channel (210) at the location of a joining point (216).
  • suction channel (217) and biopsy channel (218) are accommodated in head part (202) and merge into suction/biopsy channel (212) at the location of a joining point (220).
  • air channel (213) and water channel (214) open into opening (204) for the air/water valve (not shown).
  • Suction channel (217) opens into opening (206) for the suction valve (not shown).
  • a flexible feed hose (222) connects to head part (202) and accommodates channels (213', 214', 217'), which are connected to air channel (213), water channel (214), and suction channel (217) via respective openings (204, 206).
  • feed hose (222) may also be referred to as the light-conductor casing.
  • the mutually connecting air channels (213, 213') will collectively be referred to below as air channel (213).
  • the mutually connecting water channels (214, 214') will collectively be referred to below as water channel (214).
  • the mutually connecting suction channels (217, 217') will collectively be referred to below as suction channel (217).
  • connection (226) for air channel (213), connections (228, 228a) for water channel (214), and a connection (230) for suction channel (217) are arranged on the end section (224) (also referred to as the light conductor connector) of flexible hose (222).
  • connection (228a) is closed off.
  • a connection (232) for biopsy channel (218) is arranged on head part (202).
  • a channel separator (240) is shown inserted into openings (204, 206).
  • Channel separator (240) comprises a body (242) and plug members (244, 246), which occlude respective openings (204, 206).
  • a coaxial insert (248) on plug member (244) extends inwardly of opening (204) and terminates in an annular flange (250), which occludes a portion of opening (204) to separate channel (213) from channel (214).
  • liquid for cleaning and disinfection can be flowed through endoscope channels (213, 214, 217, 218) and out of a distal tip (252) of endoscope (200) via channels (210, 212).
  • Channel separator (240) ensures that such liquid flows all the way through endoscope (200) without leaking out of openings (204, 206); and isolates channels (213, 214) from each other so that each channel (213, 214) has its own independent flow path.
  • channel separator (240) may require modifications to channel separator (240) to accommodate such differences while occluding ports in head (202) and keeping channels separated from each other so that each channel can be flushed independently of the other channels. Otherwise, a blockage in one channel might merely redirect flow to a connected unblocked channel.
  • a leakage port (254) on end section (224) leads into an interior portion (256) of endoscope (200) and is used to check for the physical integrity thereof, namely to ensure that no leakage has formed between any of the channels and the interior (256) or from the exterior to the interior (256).
  • an operator may start by loading a device for reprocessing and making any needed connections with the device (404). To do so, the operator may actuate a foot pedal (not shown) to open basin lid (16a). Each lid (16a, 16b) may have its own foot pedal. In some versions, once pressure is removed from the foot pedal, the motion of lid (16a, 16b) stops. With lid (16a) open, the operator inserts shaft (208) of endoscope (200) into helical circulation tube (64).
  • End section (224) and head section (202) of endoscope (200) are situated within basin (14a), with feed hose (222) coiled within basin (14a) with as wide a diameter as possible.
  • flush lines (30) are attached to respective endoscope openings (226, 228, 228a, 230, 232).
  • Air line (112) is also connected to connector (254).
  • flush lines (30) are color coded, and guide located on station (10) provides a reference for the color-coded connections.
  • control system (20) may prompt the operator to enter a user code, patient ID, endoscope code, and/or specialist code. This information may be entered manually (e.g., through touch screen (22)), automatically (e.g., by using an attached barcode wand), or in any other suitable fashion. With the information entered (if required), the operator may then close lid (16a). In some versions, closing lid (16a) requires the operator to press a hardware button and a touch screen (22) button simultaneously to provide a fail-safe mechanism for preventing the operator’s hands from being caught or pinched by the closing basin lid (16a). If either the hardware button or software button is released while lid (16a) is in the process of closing, the motion of lid (16a) stops.
  • a threshold e.g., less than 100 mbar
  • the program is stopped and the operator is notified of the condition.
  • the pressure drop is monitored over the course of a certain duration (e.g., 60 seconds). If the pressure drop is faster than a predetermined rate (e.g., more than 10 mbar within 60 seconds), the program is stopped and the operator is notified of the condition. If the pressure drop is slower than a predetermined rate (e.g., less than 10 mbar in 60 seconds), reprocessing system (2) continues with the next step. A slight positive pressure is held within the body of endoscope (200) during the rest of the process to prevent fluids from leaking in.
  • a second leak test checks the adequacy of connection to the various ports (226, 228, 228a, 230, 232) and the proper placement of channel separator (240).
  • a quantity of water is admitted to basin (14a) to submerge the distal end of endoscope (200) in helical tube (64).
  • Valve (SI) is closed and valve (S7) opened; and pumps (32) are run in reverse to draw a vacuum and to ultimately draw liquid into endoscope channels (210, 212).
  • Pressure sensors (42) are monitored to make sure that the pressure in any one channel (210, 212) does not drop and/or raise by more than a predetermined amount in a given time frame.
  • control system (20) will cancel the cycle and indicate a likely faulty connection, preferably with an indication of which channel (210, 212) failed.
  • reprocessing system (2) continues wash cycle (406) with a pre-rinse cycle.
  • the purpose of this step is to flush water through channels (210, 212, 213, 214, 217, 218) to remove waste material prior to washing and disinfecting endoscope (200).
  • basin (14a) is filled with filtered water and the water level is detected by pressure sensor (59) below basin (14a).
  • the water is pumped via pumps (32) through the interior of channels (210, 212, 213, 214, 217, 218), directly to drain (74). This water is not recirculated around the exterior surfaces of endoscope (200) during this stage.
  • drain pump (72) As the water is being pumped through channels (210, 212, 213, 214, 217, 218), drain pump (72) is activated to ensure that basin (14a) is also emptied. Drain pump (72) will be turned off when drain switch (76) detects that the drain process is complete. During the draining process, a channel purge is executed where sterile air is blown via air pump (38) through all endoscope channels (210, 212, 213, 214, 217, 218) simultaneously, to minimize potential carryover.
  • wash cycle (406) continues by filling basin (14a) with warm water (e.g., approximately 35°C). Water temperature is controlled by controlling the mix of heated and unheated water. The water level is detected by pressure sensor (59). Reprocessing system (2) then adds enzymatic detergent to the water circulating in reprocessing system (2) by means of peristaltic metering pump (88). The volume is controlled by controlling the delivery time, pump speed, and inner diameter of the tubing of pump (88).
  • Detergent solution (86) is actively pumped throughout the internal endoscope channels (210, 212, 213, 214, 217, 218) and over the outer surface of endoscope (200) for a predetermined time period (e.g., from one to five minutes, or more particularly about three minutes), by channel pumps (32) and external circulation pump (70).
  • Inline heater (80) keeps the temperature at a predetermined temperature (e.g., approximately about 35° C).
  • the flow rate through channels (210, 212, 213, 214, 217, 218) is measured.
  • any channel (210, 212, 213, 214, 217, 218) is less than a predetermined rate for that channel (210, 212, 213, 214, 217, 218), the channel (210, 212, 213, 214, 217, 218) is identified as blocked, the program is stopped, and the operator is notified of the condition.
  • Peristaltic pumps (32) are run at their predetermined flow rates and cycle off in the presence of unacceptably high pressure readings at the associated pressure sensor (42). If a channel (210, 212, 213, 214, 217, 218) is blocked, the predetermined flow rate will trigger pressure sensor (42), indicating the inability to adequately pass this flow rate.
  • pumps (32) are peristaltic in the present example, their operating flow rate combined with the percentage of time they are cycled off due to pressure will provide the actual flow rate.
  • the flow rate can also be estimated based upon the decay of the pressure from the time pump (32) cycles off.
  • drain pump (72) is activated to remove detergent solution (86) from basin (14a) and channels (210, 212, 213, 214, 217, 218). Drain pump (72) turns off when drain level sensor (76) indicates that drainage is complete. During the drain process, sterile air is blown through all channels (210, 212, 213, 214, 217, 218) of endoscope (200) simultaneously to purge the channels and minimize potential carryover.
  • reprocessing system (2) begins a rinse cycle (408).
  • basin (14a) is again filled with warm water (e.g., at approximately 35° C.). Water temperature is controlled by controlling the mix of heated and unheated water. The water level is detected by pressure sensor (59).
  • the rinse water is circulated within channels (210, 212, 213, 214, 217, 218) of endoscope (200) via channel pumps (32); and over the exterior of endoscope (200) via circulation pump (70) and sprinkler arm (60) for a certain period of time (e.g., one minute).
  • the flow rate through channels (210, 212, 213, 214, 217, 218) is measured and if it falls below the predetermined rate for any given channel (210, 212, 213, 214, 217, 218), that channel (210, 212, 213, 214, 217, 218) is identified as blocked, the program is stopped, and the operator is notified of the condition.
  • drain pump (72) is activated to remove the rinse water from basin (14a) and channels (210, 212, 213, 214, 217, 218). Drain pump (72) turns off when drain level sensor (76) indicates that drainage is complete. During the drain process, sterile air is blown through all channels (210, 212, 213, 214, 217, 218) of endoscope (200) simultaneously to purge the channels and minimize potential carryover. In some versions, the above-described rinsing and draining cycles are repeated at least once again, to ensure maximum rinsing of detergent solution (86) from the surfaces of endoscope (200) and basin (14a).
  • reprocessing system (2) After reprocessing system (2) has completed the desired number of rinsing and draining cycles, reprocessing system (2) proceeds to a disinfection cycle (410).
  • basin (14a) To initiate disinfection cycle (410), basin (14a) is filled with very warm water (e.g., at approximately 53° C.). Water temperature is controlled by controlling the mix of heated and unheated water. The water level is detected by pressure sensor (59).
  • channel pumps (32) are off in order to ensure that the disinfectant solution (92) in basin (14a) is at the in-use concentration prior to circulating through channels (210, 212, 213, 214, 217, 218) of endoscope (200).
  • a measured volume of disinfectant solution (92) is drawn from disinfectant metering pre-chamber (96) and delivered into the water in basin (14a) via metering pump (100).
  • the volume of disinfectant solution (92) is controlled by the positioning of fill level switch (98) relative to the bottom of metering pre-chamber (96).
  • Metering pre chamber (96) is filled until fill level switch (98) detects liquid.
  • Disinfectant solution (92) is drawn from metering pre-chamber (96) until the level of disinfectant solution (92) in metering pre-chamber (96) is just below the tip of metering pre-chamber (96).
  • metering pre-chamber (96) is refilled from the bottle of disinfectant solution (92).
  • Disinfectant solution (92) is not added until basin (14a) is filled, so that in case of a water supply problem, concentrated disinfectant is not left on endoscope (200) with no water to rinse it.
  • channel pumps (32) are off in order to ensure that disinfectant solution (92) in basin (14a) is at the desired in-use concentration prior to circulating through channels (210, 212, 213, 214, 217, 218) of endoscope (200).
  • the in-use disinfectant solution (92) is actively pumped throughout internal channels (210, 212, 213, 214, 217, 218) by pumps (32) and over the outer surface of endoscope (200) by circulation pump (70). This may be done for any suitable duration (e.g., at least 5 minutes).
  • the temperature of the disinfectant solution (92) may be controlled by in-line heater (80) to stay at a consistent temperature (e.g., about 52.5° C).
  • flow through each channel (210, 212, 213, 214, 217, 218) of endoscope (200) is verified by timing the delivery of a measured quantity of solution through channel (210, 212, 213, 214, 217, 218).
  • Valve (SI) is closed, and valve (S7) opened, and in turn each channel pump (32) delivers a predetermined volume to its associated channel (210, 212, 213, 214, 217, 218) from metering tube (136). This volume and the time it takes to deliver the volume, provides a very accurate flow rate through the channel (210, 212, 213, 214, 217, 218). Anomalies in the flow rate from what is expected for a channel (210, 212, 213, 214, 217, 218) of that diameter and length are flagged by control system (20) and the process stopped. As in-use disinfectant solution (92) is pumped through channels (210, 212, 213, 214, 217, 218), the flow rate through channels (210, 212, 213, 214, 217, 218) is also measured as described above.
  • drain pump (72) is activated to remove disinfectant solution (92) solution from basin (14a) and channels (210, 212, 213, 214, 217, 218).
  • sterile air is blown through all channels (210, 212, 213, 214, 217, 218) of endoscope (200) simultaneously to purge channels and minimize potential carryover.
  • reprocessing system (2) begins a final rinse cycle (412).
  • basin (14a) is filled with sterile warm water (e.g., at approximately 45° C) that has been passed through a filter (e.g., a 0.2mih filter).
  • the rinse water is circulated within channels (210, 212, 213, 214, 217, 218) by pumps (32); and over the exterior of endoscope (200) via circulation pump (70) and sprinkler arm 60) for a suitable duration (e.g., 1 minute).
  • Drain pump (72) is activated to remove the rinse water from basin (14a) and channels (210, 212, 213, 214, 217, 218).
  • sterile air is blown through all channels (210, 212, 213, 214, 217, 218) of endoscope (200) simultaneously to purge channels and minimize potential carryover.
  • the above-described rinsing and draining cycles are repeated at least two more times, to ensure maximum rinsing of disinfectant solution (92) residuals from the surfaces of endoscope (200) and basin (14a).
  • reprocessing system (2) After the final rinse cycle (412) is complete, reprocessing system (2) begins a final leak test. In particular, reprocessing system (2) pressurizes the body of endoscope (200) and measures the leak rate as described above. If the final leak test is successful, reprocessing system (2) indicates the successful completion of the cycles by displaying a cycle complete indication (414) on a graphical user interface (GUI), e.g., via touch-screen (22). From the time of program completion to the time at which lid (16a) is opened, pressure within the body of endoscope (200) is normalized to atmospheric pressure by opening vent valve (S5) at a predetermined rate (e.g., valve (S5) opened for 10 seconds every minute).
  • GUI graphical user interface
  • reprocessing system (2) may prevent lid (16a) from being opened until receiving user confirmation (416), e.g., a valid user identification code may be entered to provide user confirmation.
  • user confirmation e.g., a valid user identification code may be entered to provide user confirmation.
  • Information about the completed program including the user ID, endoscope ID, specialist ID, and patient ID are stored along with the sensor data obtained throughout the program. If a printer is connected to reprocessing system (2), and if requested by the operator, a record of the disinfection program will be printed.
  • lid (16a) may be unlocked (418) and opened (e.g., using the foot pedal as described above).
  • Endoscope (200) is then removed in a device removal step (420) where endoscope (200) is disconnected from flush lines (30) and removed from basin (14a). Fid (16a) can then be closed using both the hardware and software buttons as described above. With device (200) removed from reprocessing system (2), reprocessing method (400) ends (422) and may be repeated thereafter for reprocessing additional devices, i.e. endoscopes (200).
  • FIG. 5 illustrates a flow diagram showing a user setup (500) for a modification to reprocessing method (400) that is usable with a reprocessing system, such as reprocessing system (2) of FIG. 1.
  • user setup (500) begins with a start prompt (502), after which a cycle setup screen (504) is displayed to the operator of reprocessing system (2).
  • Start prompt (502) may be achieved by opening lid (16a), or it may be achieved by receiving an input at reprocessing system (2), e.g., via a touch-screen display or other suitable input device.
  • a channel drying option (506) is presented to the operator.
  • channel drying option (506) is not selected at drying selected step (508)
  • standard channel purging (512) is performed with reprocessing method (400). As indicated in FIG. 5, such standard channel purging (512) means that there is no change in reprocessing method (400) between final rinse cycle (412) and display cycle complete on GUI (414).
  • channel drying option (506) is selected at drying selected step (508)
  • channel drying cycle (510) is added to reprocessing method (400) after final rinse (412) and prior to display cycle completion on GUI (414).
  • channel drying cycle (510) may be configured in specific ways.
  • channel drying cycle (510) in accordance with drying guidelines set forth by the Society of Gastroenterology Nurses and Associates (SGNA), channel drying cycle (510) is configured so that the channels of endoscope (200) each receive 10 minutes of blowing or continuous pressurized air. This additional drying process promotes improved channel drying, which reduces the risk of unintended bacterial growth after reprocessing.
  • channel drying cycle (510) can be configured so that the channels of endoscope (200) each receive a greater or lesser amount of drying time.
  • channel drying cycle (510) can be configured so that the manner in which pressurized air is delivered to the channels may be modified.
  • channel drying cycle (510) air is blown through the channels in one direction, while in other examples air is blown through the channels through both sides in an alternating fashion.
  • drying gases could be air, nitrogen, ozone, or other gases that would break down into harmless compounds as will be apparent to those of ordinary skill in the art in view of the teachings herein. Still further, the drying gases could be heated in some versions, but this heating would not be required in all cases. In view of the teachings herein, various other ways to configure channel drying cycle (510) will be apparent to those of ordinary skill in the art.
  • FIG. 6 illustrates a flow diagram of another reprocessing method (600) that is usable with a reprocessing system, such as reprocessing system (2) of FIG. 1.
  • reprocessing method (600) is initially identical with reprocessing method (400) through final rinse cycle (412). Thereafter, an alcohol injection into the channels (602) is performed to aid in displacing and drying the channels.
  • alcohol injection (602) is omitted such that it is considered an optional process or step.
  • a channel purge (604) occurs after the optional alcohol injection (602), with channel purge (604) aimed at using air to displace any liquid from within the channels of endoscope (200).
  • channel purge (604) is omitted such that it is considered an optional process or step.
  • a channel drying cycle (606) occurs after the optional channel purge (604).
  • Channel drying cycle (606) in the present example is configured in the same manner as channel drying cycle (510) described above. It should be noted that in some versions of reprocessing method (600), channel drying cycle (606) is omitted such that it is considered an optional process or step. In the present example, once the time for channel drying cycle (606) has elapsed, reprocessing method (600) proceeds to display cycle completion on GUI (608). In one example where alcohol injection (602), channel purge (604), and channel drying cycle (606) are omitted, reprocessing method (600) proceeds from final rinse cycle (412) to display cycle completion on GUI (608).
  • reprocessing method (600) includes a user confirm or confirmation (610) process or step.
  • an extend channel drying operation (612) is performed. With extended channel drying (612) there is extended purging or drying at the end of reprocessing method (600) until the operator removes endoscope (200) from reprocessing system (2). In this manner, there is additional time of blowing compressed or pressurized air through the channels of endoscope (200). This will in turn remove more liquid or moisture from the channels by either displacement and/or drying through evaporation.
  • reprocessing method (600) proceeds to unlock door or lid (418) of reprocessing system (2) such that the operator can then remove the device at device removal (420), at which time reprocessing method (600) ends (422).
  • confirmation from an operator or user may be accomplished by providing an input or indication that the user or operator is ready to remove the device from reprocessing system (2). Such input or indication may be performed by using a touch-screen input or other input device associated with reprocessing system (2).
  • reprocessing method (600) includes both channel drying (606) as well as extended channel drying (612). This can be beneficial as it provides assurance that a desired prescribed channel drying is performed even if the operator is waiting for reprocessing method (600) to conclude and promptly provide user confirmation to remove the device immediately or shortly after display cycle complete on GUI (608). While this may be desirable in some versions, it is not required in all versions, and some versions as mentioned above omit channel drying (606) while using extended channel drying (612). Still yet as mentioned above, some methods of reprocessing omit extended channel drying (612) and incorporate channel drying (510) as shown and described with respect to FIG. 5.
  • reprocessing system (2) and reprocessing methods (400, 600) will be apparent to those of ordinary skill in the art.
  • channel drying (510, 606) and extended channel drying (612) can be user-selected options, in some versions one or both of these processes can occur automatically as part of reprocessing methods (400, 600).
  • extended channel drying (612) may be configured in specific ways.
  • extended channel drying (612) is configured so that the channels of endoscope (200) each receive a continuous flow or blowing of pressurized air as an exemplary drying gas. This additional drying process promotes improved channel drying, which reduces the risk of unintended bacterial growth after reprocessing.
  • extended channel drying (612) can be configured so that the continuous flow of air is constant, while in other versions the flow may be continuous but pulse such that the flow changes from a low to high flowrate in an alternating fashion.
  • extended channel drying (612) can be configured so that different pressures may be used and/or the continuous delivery of pressurized air may be modified to be intermittent.
  • extended channel drying (612) air is blown through the channels in one direction, while in other examples air is blown through the channels through both sides in an alternating fashion.
  • the drying gases could be air, nitrogen, ozone, or other gases that would break down into harmless compounds as will be apparent to those of ordinary skill in the art in view of the teachings herein. Still further, the drying gases could be heated in some versions, but this heating would not be required in all cases.
  • various other ways to configure channel drying cycle (510) will be apparent to those of ordinary skill in the art.
  • a method of reprocessing a device having one or more channels includes: (a) loading the device having the one or more channels into a reprocessing system; (b) connecting each of the one or more channels of the device with one or more flush lines; (c) conducting a wash cycle and a disinfection cycle using the reprocessing system; (d) presenting an operator with an option to add a channel drying cycle, wherein the channel drying cycle occurs after the disinfection cycle; (e) conducting the channel drying cycle using the reprocessing system, wherein the channel drying cycle delivers a drying gas through the one or more channels of the device for a prescribed duration; and (f) displaying a cycle complete indication on a graphical user interface of the reprocessing system after the prescribed duration of the channel drying cycle has elapsed.
  • Example 1 The method of any one or more of Example 1 through Example 2, further comprising conducting a final rinse cycle prior to conducting the channel drying cycle.
  • Example 1 The method of any one or more of Example 1 through Example 3, further comprising soliciting user confirmation prior to unlocking a lid of the reprocessing system to make the device accessible to the user post reprocessing.
  • Example 7 The method of any one or more of Example 1 through Example 5, further comprising performing leak testing on the device prior to conducting the channel drying cycle.
  • Example 1 The method of any one or more of Example 1 through Example 6, wherein conducting the channel drying cycle is automatic, but the operator is able to bypass the step of conducting the channel drying cycle if desired.
  • Example 8 The method of any one or more of Example 1 through Example 8, wherein the drying gas is delivered from a first side of the one or more channels.
  • Example 8 The method of any one or more of Example 1 through Example 8, wherein the drying gas is delivered from a first side of the one or more channels and a second side of the one or more channels in an alternating manner.
  • Example 1 The method of any one or more of Example 1 through Example 10, further comprising conducting an extended channel drying cycle, wherein the extended channel drying cycle delivers drying gas to the one or more channels of the device until user confirmation is received at the reprocessing system that the user is ready to access the reprocessed device.
  • Example 13 The method of any one or more of Example 1 through Example 11, wherein in the extended channel drying cycle the drying gas is delivered continuously.
  • Example 1 The method of any one or more of Example 1 through Example 12, wherein in the extended channel drying cycle the drying gas is delivered at a constant flowrate.
  • a method of reprocessing a device having one or more channels includes: (a) loading the device having the one or more channels into a reprocessing system; (b) connecting each of the one or more channels of the device with one or more flush lines, wherein the one or more flush lines are configured to deliver liquid or gas to the one or more channels; (c) conducting a wash cycle and a disinfection cycle using the reprocessing system; and (d) conducting an extended channel drying cycle, wherein the extended channel drying cycle delivers drying gas to the one or more channels of the device until a user confirmation is received at the reprocessing system that the user is ready to remove the device from the reprocessing system post reprocessing.
  • Example 15 The method of any one or more of Example 15 through Example 17, wherein in the extended channel drying cycle the drying gas is delivered from a first side of the one or more channels.
  • Example 15 through Example 18 The method of any one or more of Example 15 through Example 18, further comprising displaying a cycle complete indication on a graphical user interface of the reprocessing system, wherein the cycle complete indication is displayed during the extended channel drying cycle.
  • a method of reprocessing a device having one or more channels using a reprocessing system includes: (a) connecting each of the one or more channels of the device with one or more flush lines of the reprocessing system, wherein the one or more flush lines are configured to deliver liquid or gas to the one or more channels; (b) conducting a disinfection cycle using the reprocessing system; (c) conducting an extended channel drying cycle, wherein the extended channel drying cycle delivers drying gas to the one or more channels of the device until a user confirmation is received at the reprocessing system that the user is ready to remove the device from the reprocessing system; and (d) presenting an operator with an option to add a channel drying cycle, wherein the channel drying cycle occurs after the disinfection cycle and delivers the drying gas through the one or more channels of the device for a prescribed duration.
  • channel drying and extended channel drying steps or processes described herein with respect to reprocessing methods can also apply to other reprocess methods.
  • such channel drying and extended channel drying can apply to any of the reprocessing methods described in US Patent Pub. No. 20190076009A1, entitled “Apparatus and Method to Asynchronously Fill and Purge Channels of Endoscope Simultaneously,” published March 14, 2019; and US Patent Pub. No. 20190076567A1, entitled“Apparatus and Method to Repeatedly Fill and Purge Channels of Endoscope,” published March 14, 2019, the disclosures of which are incorporated by reference herein. Still, other reprocessing methods to which channel drying and/or extended channel drying can be used will be apparent to those of ordinary skill in the art in view of the teachings herein.

Abstract

A method is provided for reprocessing an internal channel of a medical device with a reprocessing system having one or more valves, one or more fluid lines fluidly coupled with the one or more valves, and one or more air lines coupled with the one or more valves. The method includes performing an actuation of the one or more valves to direct liquid through the fluid line and into the internal channel. The method further includes purging the liquid from the internal channel. The method further includes a user selected actuation of the one or more valves to direct drying air or gas into the internal channel for a prescribed duration. The method further includes an extended channel drying stage that can also be user selected.

Description

SYSTEM AND METHOD FOR DRYING CHANNELS OF MEDICAL INSTRUMENT
DURING CLEANING
PRIORITY
[0001] This application claims priority to U.S. Provisional Patent Application Serial No.
62/858,313, filed June 6, 2019, entitled“System and Method for Drying Channels of Medical Instrument During Cleaning,” the disclosure of which is incorporated by reference herein.
BACKGROUND
[0002] The below discussion relates to the reprocessing (i.e., decontamination) of endoscopes and other instruments that are used in medical procedures. In particular, the below discussion relates to an apparatus and a method that may be used to reprocess a medical device such as an endoscope after the medical device has been used in a first medical procedure, such that the medical device may be safely used in a subsequent medical procedure. While the below discussion will speak mainly in terms of an endoscope, it should be understood that the discussion may also equally apply to certain other medical devices.
[0003] An endoscope may have one or more working channels or lumens extending along at least a portion of the length of the endoscope. Such channels may be configured to provide a pathway for passage of other medical devices, etc., into an anatomical region within a patient. These channels may be difficult to clean and/or disinfect using certain primitive cleaning and/or disinfecting techniques. Thus, the endoscope may be placed in a reprocessing system that is particularly configured to clean endoscopes, including the channels within endoscopes. Such an endoscope reprocessing system may wash and disinfect the endoscope. Such an endoscope reprocessing system may include a basin that is configured to receive the endoscope, with a pump that flows cleaning fluids over the exterior of the endoscope within the basin. The system may also include ports that couple with the working channels of the endoscope and associated pumps that flow cleaning fluids through the working channels of the endoscope. The process executed by such a dedicated endoscope reprocessing system may include a detergent washing cycle, followed by a rinsing cycle, followed by a sterilization or disinfection cycle, followed by another rinsing cycle. The sterilization or disinfection cycle may employ disinfectant solution and water rinses. The final rinsing cycle concludes with purging the endoscope channels with compressed air. Optionally, the process may further include an alcohol rinsing cycle in which the endoscope channels are filled with alcohol and then purged with compressed air to facilitate drying of the channels and thereby enhancing the decontamination effects of the process.
[0004] Examples of systems and methods that may be used to reprocess a used endoscope are described in U.S. Pat. No. 6,986,736, entitled“Automated Endoscope Reprocessor Connection with Integrity Testing,” issued January 17, 2006, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 7,479,257, entitled “Automated Endoscope Reprocessor Solution Testing,” issued January 20, 2009, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 7,686,761, entitled “Method of Detecting Proper Connection of an Endoscope to an Endoscope Reprocessor,” issued March 30, 2010, the disclosure of which is incorporated by reference herein; and U.S. Pat. No. 8,246,909, entitled “Automated Endoscope Reprocessor Germicide Concentration Monitoring System and Method,” issued August 21, 2012, the disclosure of which is incorporated by reference herein. An example of a commercially available endoscope reprocessing system is the EVOTECH Endoscope Cleaner and Reprocessor (ECR) by Advanced Sterilization Products of Irvine, California.
[0005] Some versions of reprocessing systems may provide just a single use of a certain volume of disinfectant solution, such that the used volume of disinfectant solution is disposed of after a single use of the volume of disinfectant solution upon completion of the disinfection cycle. Some other versions of reprocessing systems may provide multiple uses of the same volume of disinfectant solution. Specifically, a volume of disinfectant solution may be recovered upon completion of a disinfection cycle and then reused for one or more subsequent disinfection cycles. In some applications, for both single-use disinfectant systems and multi-use disinfectant systems alike, a concentration of the disinfectant may be monitored throughout the process of decontaminating an instrument. For instance, in a multi-use disinfectant system, a concentration level of the multi-use disinfectant may be monitored over the course of multiple disinfection cycles, and the used disinfectant may either re-used or discarded after a given disinfection cycle based at least in part on a remaining concentration of the used disinfectant. Examples of versions of reprocessing systems that provide monitoring and re-use of disinfectant solution are disclosed in U.S. Pat. No. 8,246,909, entitled “Automated Endoscope Reprocessor Germicide Concentration Monitoring System and Method,” issued August 21, 2012, the disclosure of which is incorporated by reference herein; in U.S. Pat. No. 10,201,269, entitled“Apparatus and Method for Reprocessing a Medical Device,” issued on February 12, 2019, the disclosure of which is incorporated by reference herein; and in in U.S. Patent Pub. No. 20170333584A1, entitled“Apparatus and Method to Measure Concentration of Disinfectant in Medical Device Reprocessing system,” published on November 23, 2017, the disclosure of which is incorporated by reference herein.
[0006] While a variety of systems and methods have been made and used to reprocess medical devices, it is believed that no one prior to the inventor(s) has made or used the technology as described herein.
BRIEF DESCRIPTION OF THE DRAWINGS
[0007] While the specification concludes with claims which particularly point out and distinctly claim the invention, it is believed the present invention will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings, in which like reference numerals identify the same elements and in which: [0008] FIG. 1 depicts a front elevational view of an exemplary reprocessing system;
[0009] FIG. 2 depicts a schematic diagram of the reprocessing system of FIG. 1, with only a single decontamination basin shown for clarity;
[00010] FIG. 3 depicts a cross-sectional side view of proximal and distal portions of an endoscope that may be decontaminated using the reprocessing system of FIG. 1;
[00011] FIG. 4 a depicts a flow diagram illustrating an exemplary reprocessing method useable by the reprocessing system of FIG. 1.
[00012] FIG. 5 depicts a flow diagram illustrating an exemplary user setup to add a channel drying cycle to the reprocessing method of FIG. 4; and
[00013] FIG. 6 depicts a depicts a flow diagram illustrating an exemplary modification to the reprocessing method of FIG. 4, with the internal channels of a device undergoing a channel drying cycle and an extended channel drying cycle.
[00014] The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the invention may be carried out in a variety of other ways, including those not necessarily depicted in the drawings. The accompanying drawings incorporated in and forming a part of the specification illustrate several aspects of the present invention, and together with the description serve to explain the principles of the invention; it being understood, however, that this invention is not limited to the precise arrangements shown.
DETAILED DESCRIPTION
[00015] The following description of certain examples of the technology should not be used to limit its scope. Other examples, features, aspects, embodiments, and advantages of the technology will become apparent to those skilled in the art from the following description, which is by way of illustration, one of the best modes contemplated for carrying out the technology. As will be realized, the technology described herein is capable of other different and obvious aspects, all without departing from the technology. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not restrictive.
[00016] It is further understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. that are described herein. The following-described teachings, expressions, embodiments, examples, etc. should therefore not be viewed in isolation relative to each other. Various suitable ways in which the teachings herein may be combined will be readily apparent to those of ordinary skill in the art in view of the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.
[00017] I. Exemplary Medical Device Reprocessing Apparatus
[00018] FIGS. 1-2 show an exemplary reprocessing system (2) that may be used to decontaminate endoscopes and other medical devices that include channels or lumens formed therethrough. System (2) of this example generally includes a first station (10) and a second station (12). Stations (10, 12) are at least substantially similar in all respects to provide for the decontamination of two different medical devices simultaneously or in series. First and second decontamination basins (14a, 14b) receive the contaminated devices. Each basin (14a, 14b) is selectively sealed by a respective lid (16a, 16b). In the present example, lids (16a, 16b) cooperate with respective basins (14a, 14b) to provide a microbe-blocking relationship to prevent the entrance of environmental microbes into basins (14a, 14b) during decontamination operations. By way of example only, lids (16a, 16b) may include a microbe removal or HEPA air filter formed therein for venting.
[00019] A control system (20) includes one or more microcontrollers, such as a programmable logic controller (PLC), for controlling decontamination and user interface operations. Although one control system (20) is shown herein as controlling both decontamination stations (10, 12), those skilled in the art will recognize that each station (10, 12) can include a dedicated control system. A visual display (22) displays decontamination parameters and machine conditions for an operator, and at least one printer (24) prints a hard copy output of the decontamination parameters for a record to be filed or attached to the decontaminated device or its storage packaging. It should be understood that printer (24) is merely optional. In some versions, visual display (22) is combined with a touch screen input device. In addition, or in the alternative, a keypad and/or other user input feature is provided for input of decontamination process parameters and for machine control. Other visual gauges (26) such as pressure meters and the like provide digital or analog output of decontamination or medical device leak testing data.
[00020] FIG. 2 diagrammatically illustrates just one decontamination station (10) of reprocessing system (2), but those skilled in the art will recognize that decontamination station (12) may be configured and operable just like decontamination station (10). It should also be understood that reprocessing system (2) may be provided with just one single decontamination station (10, 12) or more than two decontamination stations (10, 12).
[00021] Decontamination basin (14a) receives an endoscope (200) (see FIG. 3) or other medical device therein for decontamination. Any internal channels of endoscope (200) are connected with flush conduits, such as flush lines (30). Each flush line (30) is connected to an outlet of a corresponding pump (32), such that each flush line (30) has a dedicated pump (32) in this example. Pumps (32) of the present example comprise peristaltic pumps that pump fluid, such as liquid and air, through the flush lines (30) and any internal channels of endoscope (200). Alternatively, any other suitable kind of pump(s) may be used. In the present example, pumps (32) can either draw liquid from basin (14a) through a filtered drain and a valve (SI); or draw decontaminated air from an air supply system (36) through a valve (S2). Air supply system (36) of the present example includes a pump (38) and a microbe removal air filter (40) that filters microbes from an incoming air stream.
[00022] A pressure switch or sensor (42) is in fluid communication with each flush line (30) for sensing excessive pressure in the flush line. Any excessive pressure or lack of flow sensed may be indicative of a partial or complete blockage (e.g., by bodily tissue or dried bodily fluids) in an endoscope (200) channel to which the relevant flush line (30) is connected. The isolation of each flush line (30) relative to the other flush lines (30) allows the particular blocked channel to be easily identified and isolated, depending upon which sensor (42) senses excessive pressure or lack of flow.
[00023] Basin (14a) is in fluid communication with a water source (50), such as a utility or tap water connection including hot and cold inlets, and a mixing valve (52) flowing into a break tank (56). A microbe removal filter (54), such as a 0.2 pm or smaller absolute pore size filter, decontaminates the incoming water, which is delivered into break tank (56) through the air gap to prevent backflow. A sensor (59) monitors liquid levels within basin (14a). An optional water heater (53) can be provided if an appropriate source of hot water is not available. The condition of filter (54) can be monitored by directly monitoring the flow rate of water therethrough or indirectly by monitoring the basin fill time using a float switch or the like. When the flow rate drops below a select threshold, this indicates a partially clogged filter element that requires replacement.
[00024] A basin drain (62) drains liquid from basin (14a) through an enlarged helical tube (64) into which elongated portions of endoscope (200) can be inserted. Drain (62) is in fluid communication with a recirculation pump (70) and a drain pump (72). Recirculation pump (70) recirculates liquid from basin drain (62) to a spray nozzle assembly (60), which sprays the liquid into basin (14a) and onto endoscope (200). A coarse screen (71) and a fine screen (73) filter out particles in the recirculating fluid. Drain pump (72) pumps liquid from basin drain (62) to a utility drain (74). A level sensor (76) monitors the flow of liquid from pump (72) to utility drain (74). Pumps (70, 72) can be simultaneously operated such that liquid is sprayed into basin (14a) while basin (14a) is being drained, to encourage the flow of residue out of basin (14a) and off of endoscope (200). Of course, a single pump and a valve assembly could replace dual pumps (70, 72).
[00025] An inline heater (80) with temperature sensors (82), upstream of recirculation pump (70), heats the liquid to optimum temperatures for cleaning and/or disinfection. A pressure switch or sensor (84) measures pressure downstream of circulation pump (70). In some variations, a flow sensor is used instead of pressure sensor (84), to measure fluid flow downstream of circulation pump (70). Detergent solution (86) is metered into the flow downstream of circulation pump (70) via a metering pump (88). A float switch (90) indicates the level of detergent (86) available. Disinfectant (92) is metered into the flow upstream of circulation pump (70) via a metering pump (94). To more accurately meter disinfectant (92), pump (94) fills a metering pre-chamber (96) under control of a fluid level switch (98) and control system (20). By way of example only, disinfectant solution (92) may comprise an activated glutaraldehyde salutation, such as CIDEX® Activated Glutaraldehyde Solution by Advanced Sterilization Products of Irvine, California. By way of further example only, disinfectant solution (92) may comprise ortho- phthalaldehyde (OPA), such as CIDEX® ortho-phthalaldeyde solution by Advanced Sterilization Products of Irvine, California. By way of further example only, disinfectant solution (92) may comprise peracetic acid (PAA).
[00026] Some endoscopes (200) include a flexible outer housing or sheath surrounding the individual tubular members and the like that form the interior channels and other parts of endoscope (200). This housing defines a closed interior space, which is isolated from patient tissues and fluids during medical procedures. It may be important that the sheath be maintained intact, without cuts or other holes that would allow contamination of the interior space beneath the sheath. Therefore, reprocessing system (2) of the present example includes means for testing the integrity of such a sheath. In particular, an air pump (e.g., pump (38) or another pump (110)) pressurizes the interior space defined by the sheath of endoscope (200) through a conduit (112) and a valve (S5). In the present example, a HEPA or other microbe-removing filter (113) removes microbes from the - Si - pressurizing air. A pressure regulator (114) prevents accidental over pressurization of the sheath. Upon full pressurization, valve (S5) is closed and a pressure sensor (116) looks for a drop in pressure in conduit (112), which would indicate the escape of air through the sheath of endoscope (200). A valve (S6) selectively vents conduit (112) and the sheath of endoscope (200) through an optional filter (118) when the testing procedure is complete. An air buffer (120) smoothes out pulsation of pressure from air pump (110).
[00027] In the present example, each station (10, 12) also contains a drip basin (130) and spill sensor (132) to alert the operator to potential leaks.
[00028] An alcohol supply (134), controlled by a valve (S3), can supply alcohol to channel pumps (32) after rinsing steps, to assist in removing water from channels (210, 212, 213, 214, 217, 218) of endoscope (200).
[00029] Flow rates in lines (30) can be monitored via channel pumps (32) and pressure sensors (42). If one of pressure sensors (42) detects too high a pressure, the associated pump (32) is deactivated. The flow rate of pump (32) and its activated duration time provide a reasonable indication of the flow rate in an associated line (30). These flow rates are monitored during the process to check for blockages in any of the channels of endoscope (200). Alternatively, the decay in the pressure from the time pump (32) cycles off can also be used to estimate the flow rate, with faster decay rates being associated with higher flow rates.
[00030] A more accurate measurement of flow rate in an individual channel may be desirable to detect subtler blockages. To that end, a metering tube (136) having a plurality of level indicating sensors (138) fluidly connects to the inputs of channel pumps (32). In some versions, a reference connection is provided at a low point in metering tube (136) and a plurality of sensors (138) are arranged vertically above the reference connection. By passing a current from the reference point through the fluid to sensors (138), it can be determined which sensors (138) are immersed and therefore determine the level within metering tube (136). In addition, or in the alternative, any other suitable components and techniques may be used to sense fluid levels. By shutting valve (SI) and opening a vent valve (S7), channel pumps (32) draw exclusively from metering tube (136). The amount of fluid being drawn can be very accurately determined based upon sensors (138). By running each channel pump (32) in isolation, the flow therethrough can be accurately determined based upon the time and the volume of fluid emptied from metering tube (136).
[00031] In addition to the input and output devices described above, all of the electrical and electromechanical devices shown are operatively connected to and controlled by control system (20). Specifically, and without limitation, switches and sensors (42, 59, 76, 84, 90, 98, 114, 116, 132 136) provide input (I) to microcontroller (28), which controls the cleaning and/or disinfection cycles and other machine operations in accordance therewith. For example, microcontroller (28) includes outputs (O) that are operatively connected to pumps (32, 38, 70, 72, 88, 94, 100, 110), valves (SI, S2, S3, S5, S6, S7), and heater (80) to control these devices for effective cleaning and/or disinfection cycles and other operations.
[00032] II. Exemplary Medical Device for Use with Reprocessing Apparatus
[00033] As shown in FIG. 3, endoscope (200) has a head part (202). Head part (202) includes openings (204, 206) formed therein. During normal use of endoscope (200), an air/water valve (not shown) and a suction valve (not shown) are arranged in openings (204, 206). A flexible shaft (208) is attached to head part (202). A combined air/water channel (210) and a combined suction/biopsy channel (212) are accommodated in shaft (208). A separate air channel (213) and water channel (214) are also arranged in head part (202) and merge into air/water channel (210) at the location of a joining point (216). It will be appreciated that the term“joining point” as used herein refers to an intersecting junction rather than being limited to a geometrical point and, the terms may be used interchangeably. Furthermore, a separate suction channel (217) and biopsy channel (218) are accommodated in head part (202) and merge into suction/biopsy channel (212) at the location of a joining point (220). [00034] In head part (202), air channel (213) and water channel (214) open into opening (204) for the air/water valve (not shown). Suction channel (217) opens into opening (206) for the suction valve (not shown). Furthermore, a flexible feed hose (222) connects to head part (202) and accommodates channels (213', 214', 217'), which are connected to air channel (213), water channel (214), and suction channel (217) via respective openings (204, 206). In practice, feed hose (222) may also be referred to as the light-conductor casing. The mutually connecting air channels (213, 213') will collectively be referred to below as air channel (213). The mutually connecting water channels (214, 214') will collectively be referred to below as water channel (214). The mutually connecting suction channels (217, 217') will collectively be referred to below as suction channel (217). A connection (226) for air channel (213), connections (228, 228a) for water channel (214), and a connection (230) for suction channel (217) are arranged on the end section (224) (also referred to as the light conductor connector) of flexible hose (222). When the connection (226) is in use, connection (228a) is closed off. A connection (232) for biopsy channel (218) is arranged on head part (202).
[00035] A channel separator (240) is shown inserted into openings (204, 206). Channel separator (240) comprises a body (242) and plug members (244, 246), which occlude respective openings (204, 206). A coaxial insert (248) on plug member (244) extends inwardly of opening (204) and terminates in an annular flange (250), which occludes a portion of opening (204) to separate channel (213) from channel (214). By connecting lines (30) to openings (226, 228, 228a, 230, 232), liquid for cleaning and disinfection can be flowed through endoscope channels (213, 214, 217, 218) and out of a distal tip (252) of endoscope (200) via channels (210, 212). Channel separator (240) ensures that such liquid flows all the way through endoscope (200) without leaking out of openings (204, 206); and isolates channels (213, 214) from each other so that each channel (213, 214) has its own independent flow path. One of skill in the art will appreciate that various endoscopes having differing arrangements of channels and openings may require modifications to channel separator (240) to accommodate such differences while occluding ports in head (202) and keeping channels separated from each other so that each channel can be flushed independently of the other channels. Otherwise, a blockage in one channel might merely redirect flow to a connected unblocked channel.
[00036] A leakage port (254) on end section (224) leads into an interior portion (256) of endoscope (200) and is used to check for the physical integrity thereof, namely to ensure that no leakage has formed between any of the channels and the interior (256) or from the exterior to the interior (256).
[00037] III. Exemplary Medical Device Reprocessing Method
[00038] Referring to FIG. 4, in an exemplary use of reprocessing system (2), an operator may start by loading a device for reprocessing and making any needed connections with the device (404). To do so, the operator may actuate a foot pedal (not shown) to open basin lid (16a). Each lid (16a, 16b) may have its own foot pedal. In some versions, once pressure is removed from the foot pedal, the motion of lid (16a, 16b) stops. With lid (16a) open, the operator inserts shaft (208) of endoscope (200) into helical circulation tube (64). End section (224) and head section (202) of endoscope (200) are situated within basin (14a), with feed hose (222) coiled within basin (14a) with as wide a diameter as possible. Next, flush lines (30) are attached to respective endoscope openings (226, 228, 228a, 230, 232). Air line (112) is also connected to connector (254). In some versions, flush lines (30) are color coded, and guide located on station (10) provides a reference for the color-coded connections.
[00039] Depending on the customer-selectable configuration, control system (20) may prompt the operator to enter a user code, patient ID, endoscope code, and/or specialist code. This information may be entered manually (e.g., through touch screen (22)), automatically (e.g., by using an attached barcode wand), or in any other suitable fashion. With the information entered (if required), the operator may then close lid (16a). In some versions, closing lid (16a) requires the operator to press a hardware button and a touch screen (22) button simultaneously to provide a fail-safe mechanism for preventing the operator’s hands from being caught or pinched by the closing basin lid (16a). If either the hardware button or software button is released while lid (16a) is in the process of closing, the motion of lid (16a) stops.
[00040] Once lid (16a) is closed, the operator presses a button on touch-screen (22) to begin the wash cycle (406). At the start of wash cycle (406), air pump (38) is activated and pressure within the body of endoscope (200) is monitored. When pressure reaches a predetermined level (e.g., 250 mbar), pump (38) is deactivated, and the pressure is allowed to stabilize for a certain stabilization period (e.g., 6 seconds). If pressure has not reached a certain pressure (e.g., 250 mbar) in a certain time period (e.g., 45 seconds), the program is stopped and the operator is notified of a leak. If pressure drops below a threshold (e.g., less than 100 mbar) during the stabilization period, the program is stopped and the operator is notified of the condition. Once the pressure has stabilized, the pressure drop is monitored over the course of a certain duration (e.g., 60 seconds). If the pressure drop is faster than a predetermined rate (e.g., more than 10 mbar within 60 seconds), the program is stopped and the operator is notified of the condition. If the pressure drop is slower than a predetermined rate (e.g., less than 10 mbar in 60 seconds), reprocessing system (2) continues with the next step. A slight positive pressure is held within the body of endoscope (200) during the rest of the process to prevent fluids from leaking in.
[00041] A second leak test checks the adequacy of connection to the various ports (226, 228, 228a, 230, 232) and the proper placement of channel separator (240). A quantity of water is admitted to basin (14a) to submerge the distal end of endoscope (200) in helical tube (64). Valve (SI) is closed and valve (S7) opened; and pumps (32) are run in reverse to draw a vacuum and to ultimately draw liquid into endoscope channels (210, 212). Pressure sensors (42) are monitored to make sure that the pressure in any one channel (210, 212) does not drop and/or raise by more than a predetermined amount in a given time frame. If it does, it likely indicates that one of the connections was not made correctly and air is leaking into channel (210, 212). In any event, in the presence of an unacceptable pressure drop, control system (20) will cancel the cycle and indicate a likely faulty connection, preferably with an indication of which channel (210, 212) failed.
[00042] In the event that the leak tests are passed, reprocessing system (2) continues wash cycle (406) with a pre-rinse cycle. The purpose of this step is to flush water through channels (210, 212, 213, 214, 217, 218) to remove waste material prior to washing and disinfecting endoscope (200). To initiate the pre-rinse cycle, basin (14a) is filled with filtered water and the water level is detected by pressure sensor (59) below basin (14a). The water is pumped via pumps (32) through the interior of channels (210, 212, 213, 214, 217, 218), directly to drain (74). This water is not recirculated around the exterior surfaces of endoscope (200) during this stage. As the water is being pumped through channels (210, 212, 213, 214, 217, 218), drain pump (72) is activated to ensure that basin (14a) is also emptied. Drain pump (72) will be turned off when drain switch (76) detects that the drain process is complete. During the draining process, a channel purge is executed where sterile air is blown via air pump (38) through all endoscope channels (210, 212, 213, 214, 217, 218) simultaneously, to minimize potential carryover.
[00043] Once the pre-rinse cycle is complete, wash cycle (406) continues by filling basin (14a) with warm water (e.g., approximately 35°C). Water temperature is controlled by controlling the mix of heated and unheated water. The water level is detected by pressure sensor (59). Reprocessing system (2) then adds enzymatic detergent to the water circulating in reprocessing system (2) by means of peristaltic metering pump (88). The volume is controlled by controlling the delivery time, pump speed, and inner diameter of the tubing of pump (88). Detergent solution (86) is actively pumped throughout the internal endoscope channels (210, 212, 213, 214, 217, 218) and over the outer surface of endoscope (200) for a predetermined time period (e.g., from one to five minutes, or more particularly about three minutes), by channel pumps (32) and external circulation pump (70). Inline heater (80) keeps the temperature at a predetermined temperature (e.g., approximately about 35° C). [00044] After detergent solution (86) has been circulating for a certain period of time (e.g., a couple of minutes), the flow rate through channels (210, 212, 213, 214, 217, 218) is measured. If the flow rate through any channel (210, 212, 213, 214, 217, 218) is less than a predetermined rate for that channel (210, 212, 213, 214, 217, 218), the channel (210, 212, 213, 214, 217, 218) is identified as blocked, the program is stopped, and the operator is notified of the condition. Peristaltic pumps (32) are run at their predetermined flow rates and cycle off in the presence of unacceptably high pressure readings at the associated pressure sensor (42). If a channel (210, 212, 213, 214, 217, 218) is blocked, the predetermined flow rate will trigger pressure sensor (42), indicating the inability to adequately pass this flow rate. As pumps (32) are peristaltic in the present example, their operating flow rate combined with the percentage of time they are cycled off due to pressure will provide the actual flow rate. The flow rate can also be estimated based upon the decay of the pressure from the time pump (32) cycles off.
[00045] At the end of wash cycle (406), drain pump (72) is activated to remove detergent solution (86) from basin (14a) and channels (210, 212, 213, 214, 217, 218). Drain pump (72) turns off when drain level sensor (76) indicates that drainage is complete. During the drain process, sterile air is blown through all channels (210, 212, 213, 214, 217, 218) of endoscope (200) simultaneously to purge the channels and minimize potential carryover.
[00046] After wash cycle (406) is complete, reprocessing system (2) begins a rinse cycle (408). To initiate rinse cycle (408), basin (14a) is again filled with warm water (e.g., at approximately 35° C.). Water temperature is controlled by controlling the mix of heated and unheated water. The water level is detected by pressure sensor (59). The rinse water is circulated within channels (210, 212, 213, 214, 217, 218) of endoscope (200) via channel pumps (32); and over the exterior of endoscope (200) via circulation pump (70) and sprinkler arm (60) for a certain period of time (e.g., one minute). As rinse water is pumped through channels (210, 212, 213, 214, 217, 218), the flow rate through channels (210, 212, 213, 214, 217, 218) is measured and if it falls below the predetermined rate for any given channel (210, 212, 213, 214, 217, 218), that channel (210, 212, 213, 214, 217, 218) is identified as blocked, the program is stopped, and the operator is notified of the condition.
[00047] At the end of rinse cycle (408), drain pump (72) is activated to remove the rinse water from basin (14a) and channels (210, 212, 213, 214, 217, 218). Drain pump (72) turns off when drain level sensor (76) indicates that drainage is complete. During the drain process, sterile air is blown through all channels (210, 212, 213, 214, 217, 218) of endoscope (200) simultaneously to purge the channels and minimize potential carryover. In some versions, the above-described rinsing and draining cycles are repeated at least once again, to ensure maximum rinsing of detergent solution (86) from the surfaces of endoscope (200) and basin (14a).
[00048] After reprocessing system (2) has completed the desired number of rinsing and draining cycles, reprocessing system (2) proceeds to a disinfection cycle (410). To initiate disinfection cycle (410), basin (14a) is filled with very warm water (e.g., at approximately 53° C.). Water temperature is controlled by controlling the mix of heated and unheated water. The water level is detected by pressure sensor (59). During the filling process, channel pumps (32) are off in order to ensure that the disinfectant solution (92) in basin (14a) is at the in-use concentration prior to circulating through channels (210, 212, 213, 214, 217, 218) of endoscope (200).
[00049] Next, a measured volume of disinfectant solution (92) is drawn from disinfectant metering pre-chamber (96) and delivered into the water in basin (14a) via metering pump (100). The volume of disinfectant solution (92) is controlled by the positioning of fill level switch (98) relative to the bottom of metering pre-chamber (96). Metering pre chamber (96) is filled until fill level switch (98) detects liquid. Disinfectant solution (92) is drawn from metering pre-chamber (96) until the level of disinfectant solution (92) in metering pre-chamber (96) is just below the tip of metering pre-chamber (96). After the necessary volume is dispensed, metering pre-chamber (96) is refilled from the bottle of disinfectant solution (92). Disinfectant solution (92) is not added until basin (14a) is filled, so that in case of a water supply problem, concentrated disinfectant is not left on endoscope (200) with no water to rinse it. While disinfectant solution (92) is being added, channel pumps (32) are off in order to ensure that disinfectant solution (92) in basin (14a) is at the desired in-use concentration prior to circulating through channels (210, 212, 213, 214, 217, 218) of endoscope (200).
[00050] The in-use disinfectant solution (92) is actively pumped throughout internal channels (210, 212, 213, 214, 217, 218) by pumps (32) and over the outer surface of endoscope (200) by circulation pump (70). This may be done for any suitable duration (e.g., at least 5 minutes). The temperature of the disinfectant solution (92) may be controlled by in-line heater (80) to stay at a consistent temperature (e.g., about 52.5° C). During the disinfection process, flow through each channel (210, 212, 213, 214, 217, 218) of endoscope (200) is verified by timing the delivery of a measured quantity of solution through channel (210, 212, 213, 214, 217, 218). Valve (SI) is closed, and valve (S7) opened, and in turn each channel pump (32) delivers a predetermined volume to its associated channel (210, 212, 213, 214, 217, 218) from metering tube (136). This volume and the time it takes to deliver the volume, provides a very accurate flow rate through the channel (210, 212, 213, 214, 217, 218). Anomalies in the flow rate from what is expected for a channel (210, 212, 213, 214, 217, 218) of that diameter and length are flagged by control system (20) and the process stopped. As in-use disinfectant solution (92) is pumped through channels (210, 212, 213, 214, 217, 218), the flow rate through channels (210, 212, 213, 214, 217, 218) is also measured as described above.
[00051] At the end of disinfection cycle (410), drain pump (72) is activated to remove disinfectant solution (92) solution from basin (14a) and channels (210, 212, 213, 214, 217, 218). During the draining process, sterile air is blown through all channels (210, 212, 213, 214, 217, 218) of endoscope (200) simultaneously to purge channels and minimize potential carryover.
[00052] After disinfectant solution (92) has been drained from basin (14a), reprocessing system (2) begins a final rinse cycle (412). To initiate cycle (412), basin (14a) is filled with sterile warm water (e.g., at approximately 45° C) that has been passed through a filter (e.g., a 0.2mih filter). The rinse water is circulated within channels (210, 212, 213, 214, 217, 218) by pumps (32); and over the exterior of endoscope (200) via circulation pump (70) and sprinkler arm 60) for a suitable duration (e.g., 1 minute). As rinse water is pumped through channels (210, 212, 213, 214, 217, 218), the flow rate through channels (210, 212, 213, 214, 217, 218) is measured as described above. Drain pump (72) is activated to remove the rinse water from basin (14a) and channels (210, 212, 213, 214, 217, 218). During the draining process, sterile air is blown through all channels (210, 212, 213, 214, 217, 218) of endoscope (200) simultaneously to purge channels and minimize potential carryover. In some versions, the above-described rinsing and draining cycles are repeated at least two more times, to ensure maximum rinsing of disinfectant solution (92) residuals from the surfaces of endoscope (200) and basin (14a).
[00053] After the final rinse cycle (412) is complete, reprocessing system (2) begins a final leak test. In particular, reprocessing system (2) pressurizes the body of endoscope (200) and measures the leak rate as described above. If the final leak test is successful, reprocessing system (2) indicates the successful completion of the cycles by displaying a cycle complete indication (414) on a graphical user interface (GUI), e.g., via touch-screen (22). From the time of program completion to the time at which lid (16a) is opened, pressure within the body of endoscope (200) is normalized to atmospheric pressure by opening vent valve (S5) at a predetermined rate (e.g., valve (S5) opened for 10 seconds every minute).
[00054] Depending on customer- selected configuration, reprocessing system (2) may prevent lid (16a) from being opened until receiving user confirmation (416), e.g., a valid user identification code may be entered to provide user confirmation. Information about the completed program, including the user ID, endoscope ID, specialist ID, and patient ID are stored along with the sensor data obtained throughout the program. If a printer is connected to reprocessing system (2), and if requested by the operator, a record of the disinfection program will be printed. Once user confirmation (416) has been received, lid (16a) may be unlocked (418) and opened (e.g., using the foot pedal as described above). Endoscope (200) is then removed in a device removal step (420) where endoscope (200) is disconnected from flush lines (30) and removed from basin (14a). Fid (16a) can then be closed using both the hardware and software buttons as described above. With device (200) removed from reprocessing system (2), reprocessing method (400) ends (422) and may be repeated thereafter for reprocessing additional devices, i.e. endoscopes (200).
[00055] IV. Exemplary Medical Device Reprocessing Method with Channel Drying
[00056] FIG. 5 illustrates a flow diagram showing a user setup (500) for a modification to reprocessing method (400) that is usable with a reprocessing system, such as reprocessing system (2) of FIG. 1. In this example, user setup (500) begins with a start prompt (502), after which a cycle setup screen (504) is displayed to the operator of reprocessing system (2). Start prompt (502) may be achieved by opening lid (16a), or it may be achieved by receiving an input at reprocessing system (2), e.g., via a touch-screen display or other suitable input device. From the cycle setup screen (504), a channel drying option (506) is presented to the operator.
[00057] In the present example, if channel drying option (506) is not selected at drying selected step (508), then standard channel purging (512) is performed with reprocessing method (400). As indicated in FIG. 5, such standard channel purging (512) means that there is no change in reprocessing method (400) between final rinse cycle (412) and display cycle complete on GUI (414). If on the other hand, channel drying option (506) is selected at drying selected step (508), then channel drying cycle (510) is added to reprocessing method (400) after final rinse (412) and prior to display cycle completion on GUI (414).
[00058] When selected and performed, channel drying cycle (510) may be configured in specific ways. In the present example, in accordance with drying guidelines set forth by the Society of Gastroenterology Nurses and Associates (SGNA), channel drying cycle (510) is configured so that the channels of endoscope (200) each receive 10 minutes of blowing or continuous pressurized air. This additional drying process promotes improved channel drying, which reduces the risk of unintended bacterial growth after reprocessing. In other versions, channel drying cycle (510) can be configured so that the channels of endoscope (200) each receive a greater or lesser amount of drying time. Additionally, in some versions, channel drying cycle (510) can be configured so that the manner in which pressurized air is delivered to the channels may be modified. For instance, different pressures may be used and/or the continuous delivery of pressurized air may be modified to be intermittent. In one example of channel drying cycle (510), air is blown through the channels in one direction, while in other examples air is blown through the channels through both sides in an alternating fashion. Additionally, in some versions the drying gases could be air, nitrogen, ozone, or other gases that would break down into harmless compounds as will be apparent to those of ordinary skill in the art in view of the teachings herein. Still further, the drying gases could be heated in some versions, but this heating would not be required in all cases. In view of the teachings herein, various other ways to configure channel drying cycle (510) will be apparent to those of ordinary skill in the art.
[00059] Referring to reprocessing method (400) as modified with the addition of channel drying cycle (510), in the present example, once the time for channel drying cycle (510) has elapsed, reprocessing method (400) as modified proceeds to display cycle completion on GUI (414) and continues thereafter following the steps thereafter as illustrated in FIG. 4 and described above.
[00060] FIG. 6 illustrates a flow diagram of another reprocessing method (600) that is usable with a reprocessing system, such as reprocessing system (2) of FIG. 1. As shown in FIG. 6, reprocessing method (600) is initially identical with reprocessing method (400) through final rinse cycle (412). Thereafter, an alcohol injection into the channels (602) is performed to aid in displacing and drying the channels. It should be noted that in some versions of reprocessing method (600), alcohol injection (602) is omitted such that it is considered an optional process or step. A channel purge (604) occurs after the optional alcohol injection (602), with channel purge (604) aimed at using air to displace any liquid from within the channels of endoscope (200). It should be noted that in some versions of reprocessing method (600), channel purge (604) is omitted such that it is considered an optional process or step.
[00061] A channel drying cycle (606) occurs after the optional channel purge (604).
Channel drying cycle (606) in the present example is configured in the same manner as channel drying cycle (510) described above. It should be noted that in some versions of reprocessing method (600), channel drying cycle (606) is omitted such that it is considered an optional process or step. In the present example, once the time for channel drying cycle (606) has elapsed, reprocessing method (600) proceeds to display cycle completion on GUI (608). In one example where alcohol injection (602), channel purge (604), and channel drying cycle (606) are omitted, reprocessing method (600) proceeds from final rinse cycle (412) to display cycle completion on GUI (608).
[00062] After display cycle completion on GUI (608), reprocessing method (600) includes a user confirm or confirmation (610) process or step. According to reprocessing method (600), where no user confirmation has been received at user confirm (610), an extend channel drying operation (612) is performed. With extended channel drying (612) there is extended purging or drying at the end of reprocessing method (600) until the operator removes endoscope (200) from reprocessing system (2). In this manner, there is additional time of blowing compressed or pressurized air through the channels of endoscope (200). This will in turn remove more liquid or moisture from the channels by either displacement and/or drying through evaporation.
[00063] By way of example only, and not limitation, after display cycle complete on GUI (608), until the operator provides confirmation at user confirm (610), extended channel drying (612) occurs. Once the operator provides confirmation at user confirm (610), then reprocessing method (600) proceeds to unlock door or lid (418) of reprocessing system (2) such that the operator can then remove the device at device removal (420), at which time reprocessing method (600) ends (422). As mentioned above, confirmation from an operator or user may be accomplished by providing an input or indication that the user or operator is ready to remove the device from reprocessing system (2). Such input or indication may be performed by using a touch-screen input or other input device associated with reprocessing system (2).
[00064] As shown in FIG. 6, in one version reprocessing method (600) includes both channel drying (606) as well as extended channel drying (612). This can be beneficial as it provides assurance that a desired prescribed channel drying is performed even if the operator is waiting for reprocessing method (600) to conclude and promptly provide user confirmation to remove the device immediately or shortly after display cycle complete on GUI (608). While this may be desirable in some versions, it is not required in all versions, and some versions as mentioned above omit channel drying (606) while using extended channel drying (612). Still yet as mentioned above, some methods of reprocessing omit extended channel drying (612) and incorporate channel drying (510) as shown and described with respect to FIG. 5. In view of the teachings herein, other ways to configure reprocessing system (2) and reprocessing methods (400, 600) will be apparent to those of ordinary skill in the art. Furthermore, while both channel drying (510, 606) and extended channel drying (612) can be user-selected options, in some versions one or both of these processes can occur automatically as part of reprocessing methods (400, 600).
[00065] When extended channel drying (612) is performed, extended channel drying (612) may be configured in specific ways. In the present example, extended channel drying (612) is configured so that the channels of endoscope (200) each receive a continuous flow or blowing of pressurized air as an exemplary drying gas. This additional drying process promotes improved channel drying, which reduces the risk of unintended bacterial growth after reprocessing. In some versions, extended channel drying (612) can be configured so that the continuous flow of air is constant, while in other versions the flow may be continuous but pulse such that the flow changes from a low to high flowrate in an alternating fashion. In other words, in some versions, extended channel drying (612) can be configured so that different pressures may be used and/or the continuous delivery of pressurized air may be modified to be intermittent. In one example of extended channel drying (612), air is blown through the channels in one direction, while in other examples air is blown through the channels through both sides in an alternating fashion. Additionally, in some versions the drying gases could be air, nitrogen, ozone, or other gases that would break down into harmless compounds as will be apparent to those of ordinary skill in the art in view of the teachings herein. Still further, the drying gases could be heated in some versions, but this heating would not be required in all cases. In view of the teachings herein, various other ways to configure channel drying cycle (510) will be apparent to those of ordinary skill in the art.
[00066] V. Exemplary Combinations
[00067] The following examples relate to various non-exhaustive ways in which the teachings herein may be combined or applied. It should be understood that the following examples are not intended to restrict the coverage of any claims that may be presented at any time in this application or in subsequent filings of this application. No disclaimer is intended. The following examples are being provided for nothing more than merely illustrative purposes. It is contemplated that the various teachings herein may be arranged and applied in numerous other ways. It is also contemplated that some variations may omit certain features referred to in the below examples. Therefore, none of the aspects or features referred to below should be deemed critical unless otherwise explicitly indicated as such at a later date by the inventors or by a successor in interest to the inventors. If any claims are presented in this application or in subsequent filings related to this application that include additional features beyond those referred to below, those additional features shall not be presumed to have been added for any reason relating to patentability.
[00068] Example 1
[00069] A method of reprocessing a device having one or more channels includes: (a) loading the device having the one or more channels into a reprocessing system; (b) connecting each of the one or more channels of the device with one or more flush lines; (c) conducting a wash cycle and a disinfection cycle using the reprocessing system; (d) presenting an operator with an option to add a channel drying cycle, wherein the channel drying cycle occurs after the disinfection cycle; (e) conducting the channel drying cycle using the reprocessing system, wherein the channel drying cycle delivers a drying gas through the one or more channels of the device for a prescribed duration; and (f) displaying a cycle complete indication on a graphical user interface of the reprocessing system after the prescribed duration of the channel drying cycle has elapsed.
[00070] Example 2
[00071] The method of Example 1, wherein the prescribed duration is 10 minutes.
[00072] Example 3
[00073] The method of any one or more of Example 1 through Example 2, further comprising conducting a final rinse cycle prior to conducting the channel drying cycle.
[00074] Example 4
[00075] The method of any one or more of Example 1 through Example 3, further comprising soliciting user confirmation prior to unlocking a lid of the reprocessing system to make the device accessible to the user post reprocessing.
[00076] Example 5
[00077] The method of any one or more of Example 1 through Example 4, wherein without user confirmation the lid of the reprocessing system remains locked with the device inaccessible to the user post reprocessing.
[00078] Example 6
[00079] The method of any one or more of Example 1 through Example 5, further comprising performing leak testing on the device prior to conducting the channel drying cycle. [00080] Example 7
[00081] The method of any one or more of Example 1 through Example 6, wherein conducting the channel drying cycle is automatic, but the operator is able to bypass the step of conducting the channel drying cycle if desired.
[00082] Example 8
[00083] The method of any one or more of Example 1 through Example 7, wherein the drying gas is pressurized air.
[00084] Example 9
[00085] The method of any one or more of Example 1 through Example 8, wherein the drying gas is delivered from a first side of the one or more channels.
[00086] Example 10
[00087] The method of any one or more of Example 1 through Example 8, wherein the drying gas is delivered from a first side of the one or more channels and a second side of the one or more channels in an alternating manner.
[00088] Example 11
[00089] The method of any one or more of Example 1 through Example 10, further comprising conducting an extended channel drying cycle, wherein the extended channel drying cycle delivers drying gas to the one or more channels of the device until user confirmation is received at the reprocessing system that the user is ready to access the reprocessed device.
[00090] Example 12
[00091] The method of any one or more of Example 1 through Example 11, wherein in the extended channel drying cycle the drying gas is delivered continuously. [00092] Example 13
[00093] The method of any one or more of Example 1 through Example 12, wherein in the extended channel drying cycle the drying gas is delivered at a constant flowrate.
[00094] Example 14
[00095] The method of any one or more of Example 1 through Example 13, wherein the device is an endoscope.
[00096] Example 15
[00097] A method of reprocessing a device having one or more channels includes: (a) loading the device having the one or more channels into a reprocessing system; (b) connecting each of the one or more channels of the device with one or more flush lines, wherein the one or more flush lines are configured to deliver liquid or gas to the one or more channels; (c) conducting a wash cycle and a disinfection cycle using the reprocessing system; and (d) conducting an extended channel drying cycle, wherein the extended channel drying cycle delivers drying gas to the one or more channels of the device until a user confirmation is received at the reprocessing system that the user is ready to remove the device from the reprocessing system post reprocessing.
[00098] Example 16
[00099] The method of Example 15, wherein conducting the extended channel drying cycle is automatic.
[000100] Example 17
[000101] The method of any one or more of Example 15 through Example 16, wherein in the extended channel drying cycle the drying gas is delivered continuously.
[000102] Example 18
[000103] The method of any one or more of Example 15 through Example 17, wherein in the extended channel drying cycle the drying gas is delivered from a first side of the one or more channels.
[000104] Example 19
[000105] The method of any one or more of Example 15 through Example 18, further comprising displaying a cycle complete indication on a graphical user interface of the reprocessing system, wherein the cycle complete indication is displayed during the extended channel drying cycle.
[000106] Example 20
[000107] A method of reprocessing a device having one or more channels using a reprocessing system includes: (a) connecting each of the one or more channels of the device with one or more flush lines of the reprocessing system, wherein the one or more flush lines are configured to deliver liquid or gas to the one or more channels; (b) conducting a disinfection cycle using the reprocessing system; (c) conducting an extended channel drying cycle, wherein the extended channel drying cycle delivers drying gas to the one or more channels of the device until a user confirmation is received at the reprocessing system that the user is ready to remove the device from the reprocessing system; and (d) presenting an operator with an option to add a channel drying cycle, wherein the channel drying cycle occurs after the disinfection cycle and delivers the drying gas through the one or more channels of the device for a prescribed duration.
[000108] VI. Miscellaneous
[000109] The channel drying and extended channel drying steps or processes described herein with respect to reprocessing methods (400, 600) can also apply to other reprocess methods. For instance, such channel drying and extended channel drying can apply to any of the reprocessing methods described in US Patent Pub. No. 20190076009A1, entitled “Apparatus and Method to Asynchronously Fill and Purge Channels of Endoscope Simultaneously,” published March 14, 2019; and US Patent Pub. No. 20190076567A1, entitled“Apparatus and Method to Repeatedly Fill and Purge Channels of Endoscope,” published March 14, 2019, the disclosures of which are incorporated by reference herein. Still, other reprocessing methods to which channel drying and/or extended channel drying can be used will be apparent to those of ordinary skill in the art in view of the teachings herein.
[000110] It should be appreciated that any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.
[000111] Having shown and described various embodiments of the present invention, further adaptations of the methods and systems described herein may be accomplished by appropriate modifications by one of ordinary skill in the art without departing from the scope of the present invention. Several of such potential modifications have been mentioned, and others will be apparent to those skilled in the art. For instance, the examples, embodiments, geometries, materials, dimensions, ratios, steps, and the like discussed above are illustrative and are not required. Accordingly, the scope of the present invention should be considered in terms of the following claims and is understood not to be limited to the details of structure and operation shown and described in the specification and drawings. It should be understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. that are described herein. The following-described teachings, expressions, embodiments, examples, etc. should therefore not be viewed in isolation relative to each other. Various suitable ways in which the teachings herein may be combined will be readily apparent to those of ordinary skill in the art in view of the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.

Claims

I/We Claim:
1. A method of reprocessing a device having one or more channels, the method comprising:
(a) loading the device having the one or more channels into a reprocessing system;
(b) connecting each of the one or more channels of the device with one or more flush lines;
(c) conducting a wash cycle and a disinfection cycle using the reprocessing system;
(d) presenting an operator with an option to add a channel drying cycle, wherein the channel drying cycle occurs after the disinfection cycle;
(e) conducting the channel drying cycle using the reprocessing system, wherein the channel drying cycle delivers a drying gas through the one or more channels of the device for a prescribed duration; and
(f) displaying a cycle complete indication on a graphical user interface of the reprocessing system after the prescribed duration of the channel drying cycle has elapsed.
2. The method of claim 1, wherein the prescribed duration is 10 minutes.
3. The method of claim 1, further comprising conducting a final rinse cycle prior to conducting the channel drying cycle.
4. The method of claim 1, further comprising soliciting user confirmation prior to unlocking a lid of the reprocessing system to make the device accessible to the user post reprocessing.
5. The method of claim 4, wherein without user confirmation the lid of the reprocessing system remains locked with the device inaccessible to the user post reprocessing.
6. The method of claim 1, further comprising performing leak testing on the device prior to conducting the channel drying cycle.
7. The method of claim 1, wherein conducting the channel drying cycle is automatic, but the operator is able to bypass the step of conducting the channel drying cycle if desired.
8. The method of claim 1, wherein the drying gas is pressurized air.
9. The method of claim 1, wherein the drying gas is delivered from a first side of the one or more channels.
10. The method of claim 1, wherein the drying gas is delivered from a first side of the one or more channels and a second side of the one or more channels in an alternating manner.
11. The method of claim 1, further comprising conducting an extended channel drying cycle, wherein the extended channel drying cycle delivers drying gas to the one or more channels of the device until user confirmation is received at the reprocessing system that the user is ready to access the reprocessed device.
12. The method of claim 11, wherein in the extended channel drying cycle the drying gas is delivered continuously.
13. The method of claim 12, wherein in the extended channel drying cycle the drying gas is delivered at a constant flowrate.
14. The method of claim 1, wherein the device is an endoscope.
15. A method of reprocessing a device having one or more channels, the method comprising:
(a) loading the device having the one or more channels into a reprocessing system;
(b) connecting each of the one or more channels of the device with one or more flush lines, wherein the one or more flush lines are configured to deliver liquid or gas to the one or more channels;
(c) conducting a wash cycle and a disinfection cycle using the reprocessing system; and
(d) conducting an extended channel drying cycle, wherein the extended channel drying cycle delivers drying gas to the one or more channels of the device until a user confirmation is received at the reprocessing system that the user is ready to remove the device from the reprocessing system post reprocessing.
16. The method of claim 15, wherein conducting the extended channel drying cycle is automatic.
17. The method of claim 15, wherein in the extended channel drying cycle the drying gas is delivered continuously.
18. The method of claim 15, wherein in the extended channel drying cycle the drying gas is delivered from a first side of the one or more channels.
19. The method of claim 15, further comprising displaying a cycle complete indication on a graphical user interface of the reprocessing system, wherein the cycle complete indication is displayed during the extended channel drying cycle.
20. A method of reprocessing a device having one or more channels using a reprocessing system, the method comprising:
(a) connecting each of the one or more channels of the device with one or more flush lines of the reprocessing system, wherein the one or more flush lines are configured to deliver liquid or gas to the one or more channels;
(b) conducting a disinfection cycle using the reprocessing system;
(c) conducting an extended channel drying cycle, wherein the extended channel drying cycle delivers drying gas to the one or more channels of the device until a user confirmation is received at the reprocessing system that the user is ready to remove the device from the reprocessing system; and
(d) presenting an operator with an option to add a channel drying cycle, wherein the channel drying cycle occurs after the disinfection cycle and delivers the drying gas through the one or more channels of the device for a prescribed duration.
PCT/IB2020/000449 2019-06-06 2020-06-05 System and method for drying channels of medical instrument during cleaning WO2020245658A2 (en)

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