WO2000056203A1

WO2000056203A1 - Decontamination system for flexible endoscopes

Info

Publication number: WO2000056203A1
Application number: PCT/US2000/008117
Authority: WO
Inventors: Bill R. Sanford; Jude A. Kral; Alan J. Greszler; Ward L. Sanders; Joseph T. Sestak
Original assignee: Steris Inc.
Priority date: 1999-03-25
Filing date: 2000-03-24
Publication date: 2000-09-28

Abstract

A system (A) for cleaning soil from a medical device, such as an endoscope includes a disposable container (10, 10', 10'') which contains a dose of a concentrated cleanser (192) to provide a cleaning fluid (14) on mixing with water. In one embodiment, a suction pump (22) is connected with outlet ports of internal channels to draw cleaning fluid from the container via a connection device (20), which is connected with inlet ports of the channels. In another embodiment, the connection device (20) is connected between the source of suction and the device, and endoscope distal tip (34) is dipped in the fluid. A closure member (200, 260, 292) selectively seals an opening (212, 212', 212'') in the container against leakage of the cleaning fluid prior to use. The closure member (200) preferably includes an openable and reclosable channel seal. A moist wipe (218, 218', 218'') in a foil package (216, 216', 216'') is affixed to the container. The system provides both a cleaning fluid and a wipe in a readily accessible form which are transportable in a surgical suite without risk of spillage.

Description

DECONTAMINATION SYSTEM FOR FLEXIBLE ENDOSCOPES

This Application claims the priority of U.S. Provisional Application Serial. No .60/126 , 101, filed March 25, 1999, and U.S. Provisional Application Serial. No. 60/138,553, filed June 10, 1999.

Backcrround of the Invention

The present invention relates to the medical arts. It finds particular application in conjunction with the postoperative cleaning of endoscopes, prior to disinfection, and will be described with particular reference thereto. It should be appreciated, however, that the invention is also applicable to the cleaning of other instruments with lumens. Endoscopes, such as gastroscopes, colonoscopes, and sigmoidoscopes, are widely used in medical diagnosis, therapy, and research. A typical endoscope incorporates a control section, from which an insertion tube and a universal cord extend. The insertion tube has a distal end which includes an objective lens and light guides. The universal cord includes a connecting head at its outer end, through which the light source and power are supplied to the endoscope .

A plurality of internal channels or lumens extend through the endoscope to the distal end. These channels, which include a working channel and water and air channels, provide the various functions of the endoscope. The working channel carries a guide wire connected to forceps at the distal end. The working channel is usually also connected to a source of suction to provide suction at the distal end. The water and air channels are primarily provided to clean the objective lens. Other channels may also be provided, including auxiliary water channels which provide irrigation at the inspection site, auxiliary instrument channels, and C0₂ insufflation channels. Each of the channels includes an inlet port. Usually the instrument channel inlet port, or biopsy port, is located on the control section, while the inlet ports for suction, air and water channels are located on the connector head, although this may vary with different types of endoscopes. To maintain adequate performance of the endoscope and to stop-cross infection, it is important to clean and microbially decontaminate the endoscope after each use. During surgery, the devices become coated with blood and other protein-rich body fluids. The internal channels also become contaminated with these fluids. If left to dry on the devices, the fluids form a hardened layer of biological residue that becomes difficult to remove in the cleaning process. Not only do such residues present a barrier to sterilant penetration, but even when sterilized, they may later break down to form toxic substances which pose hazards to patients when the devices are reused.

Immediately after a surgical procedure, therefore, the devices are often rinsed in a cleaning solution, such as an enzymatic cleaner, to remove the bulk of the blood and other body fluids from their surfaces. The rinsing process is generally carried out by immersing the devices in a shallow tray of the cleaning solution. However, for devices such as endoscopes, the cleaning fluid may not penetrate the length of the internal lumens, leaving a portion of the endoscope to become coated with dry body fluids.

Moreover, to minimize handling of contaminated endoscopes, the tray of cleaning fluid is prepared prior to surgery. The tray is open, posing hazards to personnel and equipment due to spillage. It also takes up valuable space in the operating theater, since it is necessarily quite bulky to accommodate the endoscopes. The present invention provides a new and improved system and method for post-operative cleaning and disinfecting of endoscopes, and the like which overcomes the above-referenced problems and others.

summary of the Invention

In accordance with one aspect of the present invention, a post-procedure cleaning system for cleaning a device with an internal channel therethrough is provided. The system includes a connection device for selective interconnection with a port of the internal channel. The system is characterized by a container which defines an internal chamber with an opening. A concentrated cleanser is received within the container, and forms a cleaning liquid on addition of a dilution liquid. A closure member selectively seals the opening against leakage of the cleaning solution and opens to allow the cleaning solution to be withdrawn from the container and into the internal channel. A suction connector for connection with a source of suction draws the cleaning fluid through the connection device and the internal channel.

In accordance with another aspect of the present invention, a method of cleaning an instrument with an internal channel therethrough which is contaminated with a soil is provided. The method is characterized by forming a cleaning fluid in a container having a selectively sealable opening and drawing the cleaning fluid from the container through the opening and through the internal channel to remove at least a portion of the soil.

One advantage of the present invention is the provision of a concentrated enzymatic cleanser and a soil removal wipe in a single, convenient, disposable package.

Another advantage is the provision of a flat-pack container for a concentrated enzymatic cleanser which occupies minimal storage and shipping space. Yet another advantage of the present invention is that it provides an enzymatic cleanser package with a small footprint that occupies a small space during a surgery procedure without risk of spillage.

A further advantage of the present invention is that operator involvement in handling and measuring components is minimized.

A still further advantage of the present invention is that unused cleaning solution may be stored in the container prior to disposal without risk of leakage.

Still further advantages of the present invention will become apparent to those of ordinary skill in the art upon reading and understanding the following detailed description of the preferred embodiments.

Brief Description of the Drawings

The invention may take form in various components and arrangements of components, and in various steps and arrangements of steps. The drawings are only for purposes of illustrating a preferred embodiment and are not to be construed as limiting the invention.

FIGURE 1 is a perspective view of an endoscope connected with an endoscope post-procedure cleaning system according to the present invention;

FIGURE 2 is a perspective view of the endoscope prior to connection with the endoscope post-procedure cleaning system of FIGURE 1; FIGURE 3 is an top view of the distal tip of the endoscope of FIGURE 2;

FIGURE 4 is a perspective view of the connection system of FIGURE 1;

FIGURE 5 is a schematic view of the endoscope and endoscope post-procedure cleaning system of FIGURE 1 ;

FIGURE 6 is a schematic view of an alternative embodiment of an endoscope connected with an endoscope post- procedure cleaning system according to the present invention; FIGURE 7 is a top view of a manifold for an alternative embodiment of an endoscope post-procedure cleaning system according to the present invention;

FIGURE 8 is a side view of the manifold of FIGURE 7; FIGURE 9 is a perspective view of a first embodiment of a container of an endoscope post-procedure processing system in a flat, shipping configuration in accordance with a first embodiment of the present invention;

FIGURE 10 is a perspective view of the container of FIGURE 9, after filling with water;

FIGURE 11 is a perspective view of a second embodiment of a container for an endoscope post-procedure processing system in a flat, shipping configuration in accordance with the present invention; FIGURE 12 is a perspective view of a third embodiment of a container for an endoscope post-procedure processing system in a flat, shipping configuration in accordance with the present invention;

FIGURE 13 is a perspective view of the container of FIGURE 12, after filling with water;

FIGURE 14 is a side sectional view of the container of FIGURE 12;

FIGURE 15 is a side sectional view of the container of FIGURE 12, after filling with water; FIGURE 16 is an enlarged side sectional view of the neck and cap of the container of FIGURE 12, with an endoscope inserted for processing;

FIGURE 17 is a top view of the valve of FIGURE 16;

FIGURE 18 is a perspective view of container for an endoscope post-procedure cleaning system in accordance with a third embodiment of the present invention; and

FIGURE 19 is a perspective view of the container of FIGURE 18 after filling with water, showing a wipe package partially open for removing a moist wipe. Detailed Description of the Preferred Embodiments

With reference to FIGURE 1, an endoscope post-procedure cleaning system A for post-operative cleaning of an endoscope B includes a container 10, such as a flexible or collapsible bottle. The container 10 is intended to be a single use, disposable source of an endoscope cleaning solution. The container is preferably of the type which packs relatively flat when empty of fluid, or only partially filled, and expands in volume when filled with a fluid. The container of FIGURE 1 includes a body or pouch 12 formed from a flexible material, such as a thin plastic sheet which holds a cleaning liquid 14.

The system A also includes a connection device 20, which may be disposable or reusable. The connection device is connected with the endoscope B after a surgical procedure or other contaminating operation has been completed, for supplying the cleaning liquid 14 to the internal channels of the endoscope. A source of suction 22, such as a central vacuum system of the type generally found in hospitals, draws the cleaning fluid through the tubing system and through the internal channels of the endoscope in the direction of arrow C.

In the exemplary endoscope B, illustrated in FIGURES 1- 3, the endoscope includes a control section 30, an insertion tube 32, extending from the control section to a distal tip 34, and a universal cord or umbilical cable 36, also extending from the control section 30 and having a connector head 38 at its outer end.

With particular reference to FIGURE 3, the distal tip 34 of the endoscope includes an objective lens 40 and light guide 42. The endoscope includes a plurality of internal channels, each extending to the distal tip 34 of the endoscope from either the control section 30 or the connector head 38. Specifically, an air channel (not shown) has an outlet 44 at the distal tip which incorporates an air feeding nozzle to direct pressurized air across the objective lens during an operative procedure. The air feeding nozzle also provides distension of the cavity being examined. A first water channel (not shown) has an outlet 46 at the distal end. This outlet incorporates a water feeding nozzle which is arranged to direct pressurized water across the objective lens to clear debris from the lens during the operative procedure. The air channel and first water channel have a common inlet port 50 located on the connector head.

A second, auxiliary water channel (not shown) is also provided, which has an outlet 52 at the distal tip. The outlet 52 incorporates a nozzle which is arranged to direct a pressurized spray at the surface under examination during the operative procedure. The second water channel has an inlet port 54 on the control section 30. A working channel (not shown) has an outlet 56 at the distal tip. The working channel enables instruments, such as forceps, to be introduced into the cavity being examined during the operative procedure. Additionally, the working channel is connected to the source of suction 22 , such as the central vacuum system, to provide suction at the distal tip during the procedure. The working channel has a first inlet or biopsy port 58 on the control section 30 for the introduction of an instrument and a second inlet port 60 in the form of a suction barb on the connector head 38. Optionally, a CO., insufflation channel (not shown) provides C0₂ to the distal tip. The insufflation channel has an outlet 64 on the distal tip and an inlet port 66 on the connector head 38. The connector head 38 also includes an electrical terminal 68 to supply power to the endoscope and an air pipe 70.

With reference once more to FIGURE 1, and reference also to FIGURES 4 and 5, the connection device 20 is preferably configured to be specific to the endoscope to be cleaned, so that all of the internal channels which may have become contaminated with blood or other body fluids in a surgical procedure are supplied with the cleaning fluid. The connection device 20 includes a fluid supply system 80, including a plurality of fluid passages 82 in the form of tubes, which are formed from a material which is resistant to the chemical cleaner, such as plastic. The fluid passages are connected together by interconnecting members 84, such as Y-pieces 86 and 4-way connecting members 88, such that all of the fluid passages are connected with a single main fluid passage or draw tube 90. In the embodiment of FIGURES 1 and 4, the main fluid passage 90 has a distal end 92 for dipping into the cleaning fluid 14 in the container 10. While it is preferred to have a single main fluid passage 90, the use of more than one main fluid line is also contemplated. For example, each of the fluid passages 82 could be separately dipped in the cleaning fluid, and the interconnecting members 84 and main fluid passage 90 eliminated.

The fluid supply passages 82 are fitted with connectors 96, 98 100, 102, 104 at first ends, thereof, each one appropriately configured for interconnection with a particular port 58, 60, 66, 70, 54 respectively, on the connector head 38 or control section 30. Where the endoscope is produced with more than one type of inlet, the connector may be fitted with two or more alternative connectors. For example, FIGURE 4 shows two connectors 104A and 104B which may be alternately be connected with an outlet 106 of a fluid passage 82 via quick connectors 108A and 108B, respectively. The user selects either connector 104A or 104B depending on the type of inlet 54 for the auxiliary water channel on the particular endoscope to be cleaned. A fluid suction passage 110, in the form of a tube, is configured for connecting the endoscope distal tip 34 with a source of suction 22, such as the main hospital vacuum line. One or more of the connectors may be fitted with a restrictor 112, to limit the flow of the fluid entering the port. Or, a valve 114 may be positioned in the fluid passage supplying the port to adjust the pressure and or flow rate of the cleaning solution through the passage. When the vacuum source is connected with the distal tip, cleaning solution 14 is drawn from the pouch 10 through the main fluid passage 90 into the supply passages 82, and via the connectors 96, 98, 100, 102, 104 into the ports 58, 60, 66, 70, 54 on the connector head 38. The cleaning solution is drawn through the internal channels within the endoscope to the respective outlets on the distal tip, where it flows out of the endoscope and through the suction passage 110 to the suction source for disposal. Having the fluid passages connected in this way has an advantage in that the cleaning solution enters the internal channels at their cleanest ends (away from the distal tip) and is drawn toward the distal tip 34. This avoids pulling contaminants from adjacent the distal tip through the cleaner portions of the internal channels.

Plugs 120 are used to block those interior channels not to be suppled with the cleaning fluid. For example, FIGURES 1 and 5 show the common inlet port 50 for the air and water channels fitted with a plug 120. In an alternative embodiment, shown in FIGURE 6, the direction of flow through the endoscope is reversed. Cleaning fluid enters the endoscope via the distal tip 34 and passes through the endoscope in the direction of arrow D. The tip 34 is either dipped directly in the cleaning solution 14, as shown in FIGURE 6, or a piece of tubing similar to fluid suction passage 110 is attached to the tip and the fluid drawn through a distal end thereof. The same connection device 20 is used. However, in this embodiment, the connection device carries the cleaning fluid from the endoscope ports to the source of suction. A main fluid passage 90', in this case, connects the connection device with the source of suction 22.

Optionally, one or more of the ports on the endoscope is supplied with a separate cleaning fluid. As shown in FIGURE 6, the auxiliary water inlet port 54 is supplied with a fluid through a connectable inlet tube 124, from a second source of cleaning fluid 126, such as a syringe. The fluid may be a second cleaning liquid or the same cleaning liquid 14 as is used in the container 10.

With reference once more to FIGURE 4, the connection device 20 also includes a tethering system 130, which is preferably specific to the endoscope to be cleaned. The tethering system is used to connect plugs 120 to the device 20 to prevent them from being misplaced during storage. Like the remainder of the connection device, the tethering system may be designed for single use, or to be cleaned and later reused. The tethering system includes one or more tethers or straps 132, each one attached at one end to a portion of the tubing or other part of the connecting system, and at the other end to one or more of the plugs. Plugs can also be used to plug any of the fluid passages 82 not in use for a particular device. For example, a plug 133, may be used to plug the end 106 of the appropriate fluid passage 82 if there is no auxiliary water channel port on a particular endoscope to be cleaned.

Preferably, each connection system has its own tag 134, which is connected by a strap, or other connecting member to the connecting system. The tag 134 carries an indicia of the model or family of models of endoscope which are to be used with the connection device. The tag further includes a diagram illustrating how each of the connectors is to be connected with the appropriate endoscope port. Step by step instructions are also included. Each of the connectors 96, 98, 100, 102, 104 and plugs 120, 133 includes a sequential reference character, such as a number or letter, which identifies each connector and each plug and correlates the connectors and plugs with the instructions and the order in which they are to be connected. Alternatively, or additionally, the connectors may be color coded to match colored markings on the endoscope ports and/or on the tag. If desired, various techniques may be utilized to limit each fitting (connector or plug) to be connected with only a specific one or ones of the ports such as different diameters, different connecting mechanisms (threaded, bayonet, etc.), different shapes, and the like. The connectors and plugs are each configured to mate with the appropriate ports on the endoscope identified by the tag. This provides a ready indication to the operator that the plugs and connectors have not been connected properly or that the connection system has been selected.

A wide variety of plugs, connectors, and tethers are contemplated. Different endoscope manufacturers, and even the same manufacturer within different families of endoscopes, use different types and sizes of port structures. The appropriate connectors and plugs for each of the outlet port structures is preassembled into the connection system for a particular endoscope or endoscope family. Preferably, all of the components of the connection system are constructed of a material which allows them to be sterilized, for example in a liquid peracetic acid immersion or spray sterilization system.

With reference now to FIGURES 7 and 8, an alternative connection device 140 includes a manifold 141 with a plurality of tubes 142, 144, 146, 148, 150 for connection with the various ports 58, 54, 60, 70 (and optionally 50), and 66, respectively, of the endoscope. The tubes are fitted with connectors at their distal ends, analogous to the connectors 96, 98, 100, 102, 104. The manifold 141 connects the tubes 142, 144, 146, 148, 150 with a main fluid passage 154 which is selectively attached to the source of suction 22. Schematic drawings 156, 158 printed on a housing 159 of the manifold 141 illustrate the control section 30 and connector head 38 of an endoscope and show where each of the connectors is to be attached.

The tubes 142, 144, 146, 148, 150 are removably connected with the manifold 141, so that they can be replaced and cleaned and/or sterilized after each use. For example, quick connects 160 may be used to quickly connect the tubes with the manifold. Preferably, the entire manifold is constructed of materials which permit sterilization of the manifold, such as in a liquid peracetic acid immersion or spray sterilization system.

The manifold 141 includes a main valve 162, housed by the housing 159, which is movable between two positions, one for bronchoscopes, the other for other endoscopes, such as gastroscopes, colonoscopes, and sigmoidoscopes. For bronchoscopes, only the suction and biopsy flows are generally used, with the remaining outlets being closed by the main valve. For other devices, the additional flow channels are used (such as auxiliary water, air/water, and the like) .

A second, biopsy flow valve 164 is optionally housed by the manifold housing and is variably adjustable between an open and closed position to regulate the pressure applied to the endoscope biopsy port. For bronchoscopes, the biopsy flow valve is set to open where the particular bronchoscope to be cleaned has a biopsy channel, or set to the closed position where there is no biopsy channel. For other endoscopes, the biopsy flow valve is either set on the open position throughout a cleaning operation, or is closed initially, then opened once the supply to the remaining channels has begun. Preferably, the valves 162, 164 are removable from the manifold for cleaning and/or sterilization. The housing 159 is preferably weighted and has a non- skid base 166 to inhibit the housing and the connected tubing from slipping off a surface.

With reference also to FIGURES 9-19, a variety of containers 10 for providing a source of cleaning solution are contemplated. In the embodiment of FIGURES 9-10, the container 10 comprises a pouch 12, which preferably has a pair of generally rectangular walls 176, which define a front face 178 and a rear face 180 of the container, respectively, and an expandable fold-out base 182. The walls are connected along peripheral side edges 184 and 186 to each other, and along a lower edge 188 to the base 182. When filled with water, the base unfolds along a center side-to-side fold to expand and folds over-center along a center front-to back crease to lock itself in the expanded state. In this manner, the container expands in volume to the configuration shown in FIGURE 10 with the bottom edges 188 of walls 176 providing a flat, oval surface for supporting the container in an upstanding position. The container is preferably formed from a transparent material so that the interior is visible during use. Although a flat-pack container of the type described is preferred for minimizing the space occupied by the container during storage, other containers, such as rigid-sided containers are also contemplated.

The container 12 defines an internal chamber 190 which is prepackaged with a measured dose of a concentrated cleanser 192, such as a powdered enzymatic cleanser, that occupies little of the space in the chamber prior to use. Liquid concentrates as well as powdered systems are contemplated. When diluted with water, the concentrated cleanser forms the cleaning solution 14 for removing blood and other biological matter from internal surfaces of an endoscope, or other medical device having an internal passageway. The size of the container 10 is determined by the volume of cleaning solution 14 desired for cleaning the interior of the device. For most purposes, an internal volume of about 250-500 ml provides a sufficient volume of cleaning solution for medical instruments, although for larger instruments, an internal volume of up to about 1000 ml may be utilized. A fill line 196, visible on one or both of the faces 178, 180 of the container body, indicates the level to which the container should be filled with water to provide the correct dilution of the concentrated cleanser 192.

An upper end of the body includes a closure or channel seal 200, such as a molded Zip-lock™ closure, for sealing the concentrated cleanser 192 in the container during storage. The closure 200 includes a pair of parallel protrusions 202, 204 on an interior surface one of the front and rear walls 176 of the body define a channel for engaging a third protrusion 206 on the corresponding interior surface of the other of the front and rear panels. The channel seal 200 is openable and reclosable, and may be partially closed around a fluid supply tube for the endoscope, such as the endoscope distal tip 34 as shown in FIGURES 6 and 10, main fluid passage 90, as shown in FIGURE 1, or other fluid supply passage.

A removable closure, such as a heat sealed strip 210, formed by heat welding the front and rear walls together upward of the closure 200, closes an upper open end 212 of the container body. The strip 210 provides an additional barrier to the loss of concentrated cleanser during storage and provides an indication of tampering if the strip has been opened prior to use.

Preferably, a sealed package 216, formed from thin foil or other moisture impermeable material, and containing a moist wipe 218, is attached to the front or rear face of the container. The wipe is preferably pre-moistened with a cleaning agent, such as a liquid soap or detergent, and/or a microbiocidal disinfecting solution, such as a quatrammonium amine cleaning solution, or may contain another suitable cleaner or disinfectant. The wipe is wiped over the outer surface of the endoscope to remove the bulk of any soil thereon, such as blood and other body fluids. The antimicrobial agent, where present, begins the destruction of microorganisms present on the exterior surfaces.

For more thorough cleaning, two or more moist wipes 218 are preferably provided, either together in a single package 216, or in separate packages. For example, the first wipe may be used to remove gross debris from the most heavily contaminated areas of the endoscope, such as the insertion tube 32 and the distal tip 34. The second wipe is then used to clean the less heavily contaminated areas of the endoscope, such as the control handle 30, umbilical cable 36, and connector head 38. After wiping off these components, the second wipe may be passed over the insertion tube and distal tip to reduce further the level of soil contamination of the instrument. A procedure such as this removes the bulk of the soil on the exterior of the instrument, leaving only a small amount remaining. This small amount is easily removed in a subsequent cleaning and/ or antimicrobial decontamination cycle.

Preferably, the package 216 is attached along a first edge only, such as the left side 220. When the container is filled with water and bows out, a second, opposite side 222 is pushed outward by the shape of the filled container to present itself for readily grasping by a user, as shown in FIGURE 10. A notch 224 is formed in an upper edge of the package, adjacent the second edge, to facilitate tearing open the package to expose the wipe. After use of the endoscope, the wipe is extracted to wipe the exterior of the endoscope.

In alternate embodiment of a wipe package 230, shown in FIGURE 11, the package comprises a pull down flap 232 which is sealed around a peripheral edge 234 to the front face of the container with a peelable adhesive. A pull tab 236 on an upper end of the flap is grasped to peel the flap from the container and reveal the moist wipe.

With reference once more to FIGURES 9 and 10, the walls 176 of the container 10 are sealed together in one or more enlarged, tab-like portions 240, adjacent an upper corner and an aperture 242 is formed in the sealed portion 240 for hanging the container on a suitable hook in the surgery room, such as a hook on an I.V. stand. In use, the container 10 is preferably filled with water prior to a surgery procedure so that the cleaning fluid 14 is ready for cleaning an endoscope as soon as the surgery is completed. The heat-sealed strip 210 is torn off or otherwise removed and the Zip-lock™ closure 200 is opened to add the water to the container 10. The container may be shaken to mix the concentrated cleaner 192 with the water. The wipe package 216 is ripped open along the edge at this stage, so that the wipe 218 is readily accessible with one hand. The closure 200 is then resealed.

The water used for diluting the concentrated cleaner may be tap water or purified water, such as distilled water, and may be at room temperature or other suitable temperature. Where the cleaning liquid 14 is particularly active at a particular temperature the water is preferably heated to around that temperature. The water may be heated prior to addition to the pouch 12, or, the pouch and liquid cleaning fluid 14 may be heated prior to use, for example, by immersion of a lower end of the pouch in a bath of heated water.

When the surgery is complete, or the endoscope is no longer required, the moist wipe 218 is removed from the foil package 216 and used to remove body fluids from exterior surfaces 246 of the endoscope and begin to disinfect the surfaces. This reduces hazards posed to the user when handling the contaminated endoscope. During this procedure, the suction end of the connecting device (i.e., the fluid suction passage 110 in FIGURE 1 or the distal end 92' of the main fluid passage 90' in FIGURE 6) of the fluid supply system 80, is preferably connected with the source of suction 22, such as a central vacuum system of the type generally found in hospitals. The supply end (i.e., the distal end 90 of the main fluid passage in FIGURE 1 or the distal tip 34, as shown in FIGURE 6) is then inserted, in the direction of arrow D, through the opening 212 and into the container chamber 190. The suction source draws the cleaning solution 14 through the endoscope, as described above. Blood and other biological fluids are removed from the surfaces of the interior channels of the endoscope by the cleaning fluid and carried out of the endoscope by the suction source. The channel seal 200 is optionally partially sealed around the supply end during this procedure.

Typically, the internal volume of the endoscope internal channels is around 25 ml or less. The volume of fluid 14 in the container is preferably such that the channels are thoroughly flushed several times with fresh cleaning solution 14 before the process is complete. By thoroughly wetting the walls of the internal lumens during the flushing process, traces of the biological fluids left in the endoscope internal channels are inhibited from drying out or polymerizing and inhibiting subsequent cleaning and disinfecting. Optionally, the endoscope is disconnected from the suction source before all of the cleaning solution has been drawn through the endoscope, leaving a portion of the cleaning solution in the endoscope interior channels to maintain the channels in a relatively wet state.

Once the supply end has been removed from the container 10, the channel seal 200 is preferably closed once more to seal the container. This prevents leakage of any cleaning solution 14 remaining in the container 10 prior to disposal. Alternatively, the remaining cleaning fluid can be squirted from the container into a suitable disposal vessel by compressing the sides of the container, or withdrawn from the container by a suction hose inserted through the opening

212.

The endoscope can be left for some time without risk of any remaining soil on the endoscope drying out, generally from several minutes to an hour or more, depending on the temperature, type of soil, and the like. Even if the soil does dry, it has been reduced to a very thin layer or spots which can still be removed in a subsequent cleaning and/or antimicrobial decontamination process, or which are so thin that they do not prevent antimicrobial agents from penetrating the layer to destroy microorganisms.

Following flushing the endoscope with the cleaning solution 14 and wiping the exterior with the wipe, the endoscope is subjected to one or more cleaning and/or antimicrobial decontamination processes. For example, the endoscope may be washed in an automated washer and/or sterilized or disinfected in a sterilization system, such as a liquid-based system, for example, a peracetic acid sterilization system, or a vapor-based system, such as an ethylene oxide sterilization system.

With reference now to FIGURES 12-17 an alternative embodiment of a container 10' is shown. The system has a similar container to that of FIGURES 1 and 9-10, and thus like parts will be identified by a primed (') numeral. Different parts are accorded new numerals. A threaded cap 250 closes an opening 212' defined by a neck 252 at an upper end of the container. The cap includes a top 254 with a central aperture 256 and a threaded skirt 258 which extends from a peripheral edge of the top to engage threads on the neck 252. The central aperture is of sufficient width to receive the supply end (i.e., the endoscope tip 34 of FIGURE 6 or main fluid passage 90 of FIGURE 1) therethrough. With particular reference to FIGURES 16 and 17, a closure member 260 covers the cap central aperture 256. The closure member is one which is readily penetrated by the endoscope tip 34 and yet prevents the cleaning solution 14 from leaking from the bottle during a surgical procedure, even when the container is tipped from its upright position. One preferred closure member comprises a slit valve 262. The slit valve 262 includes a concave, or dish-shaped portion 266, which is formed from a flexible material, such as rubber, and an annular flange or lip 268, which extends laterally from a periphery of the concave portion. The flange 268 of the valve is sealed to the cap such that the concave portion extends into the neck 252 of the container. As shown in FIGURE 14, the concave portion includes a generally cylindrical side wall 270, which is connected at a first, open end to the flange 268, and a flexible base or diaphragm 272, which closes a second end of the side wall.

The valve comprises one or more slits 280, which are formed in the diaphragm 272. As shown in FIGURE 17, the slits intersect in a crossing pattern, although other configurations are also contemplated. Until the diaphragm of the valve is distorted, the slits remain in close contact with each other to form a seal against leakage of the cleaning solution 14. Sectors or flaps 282 between the slits flex inward into the neck when depressed by the distal tip 34 of the endoscope or other supply passage, to allow the endoscope tip or other passage to enter the container, as shown in FIGURE 16. When the supply end is the endoscope tip 34, the slits are of sufficient length to accommodate the endoscope tip, which typically has a diameter of around 4-15 mm.

Optionally, as shown in FIGURE 16, the valve flange is clamped between the top 254 of the cap and an annular restraining member 286, which is attached to the cap 250 with adhesive, threads, plastic welding, or other suitable attachment system. Alternatively, the valve flange 268 may be positioned beneath the cap top 254 such that it forms a seal between a lower side of the cap top 254 and an upper end of the container neck 252. Of course, other closures, such as a frangible diaphragm, are also contemplated.

In use, the container 10', like container 10, is preferably filled with water prior to a surgical procedure so that the container is ready for cleaning an endoscope as soon as the surgery is completed. The cap 250 is removed to add the water to the pouch 12 ' and then replaced over the neck 252 of the container 10'. The container may be shaken to mix the concentrated cleanser 192 with the water. The wipe package 216' is ripped open along the edge at this stage so that the wipe 218' is readily accessible with one hand.

The supply end (endoscope tip 34 or main passage 90) is then inserted, in the direction of arrow E, through the slits 280 in the diaphragm 272 and into the container chamber 190'. The flaps 282 of the diaphragm flex downward to allow the tip or other supply end through the diaphragm 272. The suction source is attached to the connection end of the connection device 20 so that it draws the cleaning solution 14 through the tip 34 or other supply end and into the internal channels of the endoscope. Blood and other biological fluids are removed from the endoscope tube surfaces by the cleaning fluid and carried out of the endoscope second end by the suction source. The source of suction 22 is disconnected before all of the cleaning fluid 14 is drawn through to leave a portion of the cleaning fluid in the internal passage.

Optionally, the remaining cleaning fluid in the container 10, 10' is squirted from the container into a suitable disposal vessel by compressing the sides of the container, or withdrawn from the container by a suction hose inserted through the valve 262 or opening. This prevents leakage of any cleaning solution 14 remaining in the container 10, 10' prior to disposal.

With reference now to FIGURES 18 and 19, a third embodiment of a container 10'' for the endoscope post- procedure cleaning system is shown. The container 10'' is similar in many respects to the containers 10 and 10' and thus like parts will be identified by a double primed ('') numeral. Different parts are accorded new numerals.

As for container 10', container 10'' includes a pouch 12'' and a threaded neck 290. A closure member 292 is tethered to the container neck by a flexible strap 294 with an annular ring 296 at a distal end thereof. The ring is seated around the container neck 290, below the threadings. Prior to use, the closure member 292 is positioned away from the opening of the neck 290, as shown in FIGURE 18.

The closure member 292 includes a slitted valve 298. The valve 298 includes a frustoconical portion or tapered side wall 300, which is formed from a resilient material, such as silicone rubber, with an annular flange or lip 302, which extends laterally from adjacent an open end of the frustoconical portion. The flange 302 is connected to a proximal end 304 of the strap. A concave base 306 closes a second end of the side wall 300. The side wall 300 is shaped for frictional engagement with an interior surface of the container neck, as shown in FIGURE 19. The base 306 has a slit 308 formed therein, analogous to the crossing slits of embodiment 10'. Prior to use, a cap 310 closes the neck opening 212''. The cap is similar to the cap of embodiment 10', except in that it lacks a central aperture. When the container 10'' is to be prepared for use, the cap 310 is removed and the container body 12'' filled with water to the fill line 196'', diluting the cleaner concentrate 192. The closure member 292 is then inserted into the container neck 252 with the flange 302 resting on an upper end 308 of the neck, as shown in FIGURE 19. In the process of inserting the closure member, the valve is inverted. The system is then ready for use, essentially as described for embodiment 10'.

The valve 298 remains seated in the neck 252, sealing the opening 212'' against leakage of the cleaning solution, even when the container 10'' is tipped over. As will readily be appreciated, the endoscope post- procedure cleaning system A is not intended to replace conventional medical instrument disinfection systems. Rather, it is designed to be used in a precleaning step to remove bulk amounts of body fluids from interior and exterior surfaces of medical devices. This is to prevent the buildup of dried-on residues of these fluids, which are difficult to remove in a subsequent disinfection/cleaning process.

Without intending to limit the scope of the present invention, the following example demonstrates the effectiveness of the endoscope reprocessing system A.

EXAMPLE

Internal lumens of two endoscopes (a Pentax FB-18X™ bronchoscope and a FC-38LX™ colonoscope) were soiled with a protein-rich soil material (75% Edinburgh™ soil heated to

37 °C in water). A suction pump was used to draw the soil material through the internal lumens.

Without allowing the soil to dry in the instruments, a selected volume (100, 232, or 500 ml) of an enzymatic cleaning fluid (a solution of 25 g/liter Klenzyme™, obtainable from Steris Corporation, in water) was drawn through the internal lumens at a preselected temperature (25°C or 45°C) . Control tests were carried out in which the cleaning fluid was water, without any Klenzyme™. A residual volume of the cleaning fluid was left in the lumens. After 15 minutes, the residual volume was suctioned from the internal lumens and the lumens were flushed with five, consecutive, deionized water flushes of 20 ml each. An endoscope brush was used with the latter 3 flushes. All of the flush water was sonicated for ten minutes and assayed for protein levels using a protein determination assay (spectrometric Bio Rad™ protein determination assay) . Results are shown in TABLE 1.

The data was normalized to determine the amount of remaining protein per lumen surface area and statistically analyzed using the ANOVA General Linear Model and Tukey's Test, where statistical significance was indicated by a p- value of < 0.05. The parameters analyzed were suction volume, presence of enzymatic cleanser, temperature, and device. All two-factor interactions were also evaluated statistically, and the residual volume was included as a covariate. The statistical analysis indicated that the presence of enzyme and suction volume were statistically significant parameters. Tukey's test indicated that, for this test, there was only statistical significant differences between the 100 ml and either the 232 ml or 500 ml volumes. For the enzymatic cleanser at the concentration used in this test, temperature was not found to be statistically significant.

TABLE 1

Evaluation of Protein Levels Remaining on Instruments

Cleaned with the Instrument Reprocessing System A

Claims

Having thus described the preferred embodiment, the invention is now claimed to be:

1. A post-procedure cleaning system (A) for cleaning a device (B) with an internal channel therethrough, the system comprising a connection device (20) for selective interconnection with a port (54, 58, 60, 66, 70) of the internal channel, the system characterized by: a container (10, 10', 10'') which defines an internal chamber (190) with an opening (212, 212', 212''); a concentrated cleanser (192) received within the container, which forms a cleaning liquid (14) on addition of a dilution liquid; a closure member (200, 260, 292) which selectively seals the opening against leakage of the cleaning solution and opens to allow the cleaning solution to be withdrawn from the container and into the internal channel; and a suction connector (110, 90') for connection with a source of suction (22) which draws the cleaning fluid through the connection device and the internal channel.

2. The system of claim 1, further characterized by the closure member (200) including a channel seal closure.

3. The system of either one of claims 1 and 2, further characterized by a removable closure (210, 250) which closes the opening against loss of the concentrated cleaner during storage.

4. The system of claim 3, further characterized by the removable closure including a tearable heat strip seal (210) .

5. The system of any one of preceding claims 1-3, further characterized by the connection system including: a plurality of fluid supply passages (82) , each of the supply passages configured for selectively connecting with a port (54, 58, 60, 66, 70) of an internal channel of the device; and a main supply passage (90, 90') fluidly connected with the fluid supply passages (82) .

6. The system of claim 5, further characterized by the main supply passage (90) having a distal end (92) which is selectively received by the opening for drawing the cleaning fluid (14) from the container (10, 10', 10'') into the fluid supply passages (82) and the internal channels when suction is applied by the source of suction (22) .

7. The system of claim 6, further characterized by the connection device (20) further including a fluid suction passage (110) for selectively fluidly connecting an outlet port (44, 46, 52, 56, 64) of the internal channel with the source of suction (22) .

8. The system of claim 7, further characterized by the device being an endoscope and the fluid suction passage (110) being selectively fluidly connectable with a distal tip (34) of the endoscope in which the outlet port (44, 46, 52, 56, 64) of the internal channel is formed.

9. The system of any one of preceding claims 1 and claims 3-8, further characterized by the closure member including a valve (262, 298) having a flexible portion which defines a slit (280, 308) for yieldingly receiving a withdrawing tube (34, 90) therethrough.

10. The system of any one of preceding claims 1-9, further characterized by the container (10, 10', 10'') including a flexible pouch (12, 12', 12'') which packs flat for storage and expands in volume when the dilution liquid is added to the container.

11. The system of claim 10, further characterized by the pouch (12, 12', 12'') including side walls (176, 176', 176'') and a base (182, 182', 182''), the base expanding and separating lower edges (188, 188', 188'') of the side walls such that the edges support the system in an upright position when the dilution liquid is added to the container (10, 10', 10").

12. The system of any one of preceding claims 1-11, further characterized by: a package (216, 216', 216'') being affixed to a front face of the pouch (12, 12', 12''), the package containing a moist wipe (218, 218', 218").

13. The system of claim 12, further characterized by: the pouch (12, 12', 12") being flexible such that it packs flat for storage and expands in volume when the dilution liquid is added to the container; and the package (218, 218', 218'') being affixed to the pouch at a first side (220, 220', 220'') of the package, such that a second side (220, 220', 220") of the package is displaced from the pouch to present itself as the pouch expands.

14. The system of any one of preceding claims 1-13, further characterized by the connection device (20) further including at least one plug (120) for plugging at least one port (50) of an internal channel of the device (B) and a tether (132) , which tethers the plug to the connection device.

15. The system of any one of preceding claims 5-8, further characterized by: each of the passages (82) having an identification mark (136) which identifies the passage; and the connection system (20) including a tag (134) which identifies which port (54, 58, 60, 66, 70) each passage is to be connected with, by reference to the identification marks.

16. A method of cleaning an instrument with an internal channel therethrough which is contaminated with a soil, the method characterized by: forming a cleaning fluid (14) in a container (10, 10', 10'') having a selectively sealable opening (212, 212', 212") ; and drawing the cleaning fluid from the container through the opening and through the internal channel to remove at least a portion of the soil.

17. The method of claim 16, further characterized by: the instrument including a plurality of internal channels which are contaminated with the soil, the step of drawing the cleaning fluid from the container including: connecting a plurality of fluid passages (82) with first ends of the internal channels, the fluid passages being fluidly connected with a main fluid passage (90) ; connecting a source of suction (22) with second ends of the internal passages; and inserting the main fluid passage (90) through the opening (212, 212', 212") into the cleaning fluid (14).

18. The method of either one of claims 16 and 17, further characterized by: the container including a closure member (200, 260,

292) which selectively seals the opening (212, 212', 212'') in the container against leakage of the cleaning solution, and the method further including, after the step of forming the cleaning fluid; sealing the opening with the closure member.

19. The method of any one of preceding claims 16-18, further characterized by: the step of forming the cleaning fluid including: adding a dilution fluid to a dose of a concentrated cleanser (192) in the container.

20. The method of any one of preceding claims 16-19 further characterized by: wiping an exterior surface (246) of the instrument with a moist wipe (218, 218', 218") which is stored in a package (216, 216', 216") attached to an exterior face (178) of the container.

21. A post-procedure cleaning system for cleaning a device (B) with an internal channel therethrough, the system characterized by: a container (10, 10', 10'') which defines an internal chamber (190) with an opening (212, 212', 212"); a cleaning liquid (14) received within the chamber; and a package (216, 216', 216") affixed to a front face of the container, the package containing a moist wipe (218,

218', 218").