Systems and methods for removing biomatter and biofilms from medical devices

Abstract

A system comprises a source of enzymatic detergent and a cleaning device comprising an elongate member configured for advancement through a lumen within a medical device and at least one cleaning member coupled to a portion of the elongate member. The cleaning member comprises distal and proximal end portions and a central portion between the distal and proximal end portions. The central portion is shaped to create a pressure gradient along the central portion from the distal end portion to the proximal end portion. The combination of the enzymatic detergent and the unique nature of the cleaning device is sufficient to remove pre-existing biomatter from the surfaces of the medical device, such as biomatter that has already formed into a biofilm. The detergent loosens the protective layer of polysaccharides and proteins of the biofilm and the cleaning device then removes both the protective layer and the underlying biomatter.

Description

International Patent ApplicationAttorney Docket No. : GI 099-PCTSYSTEMS AND METHODS FOR REMOVING BIOMATTER AND BIOFILMS FROM MEDICAL DEVICESCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application Serial No. 63 / 702,065, filed October 1, 2024, the complete disclosure of which is incorporated herein by reference for all purposes.BACKGROUND

[0002] Endoscopes and other medical devices are used and reprocessed numerous times each day to deliver highly advanced optical performance, consistent real-time imaging transmission, predictable scope handling and other functionality important to successful diagnosis and treatment of clinical conditions. This also occurs in non-medical applications involving the inspection, cleaning, and repair of remote locations with non-medical endoscopes. This includes, by way of example, but not limitation, the inspection and repair of hydraulic lines, oil field pipelines, oil refinery lines and lumens, sewer and plumbing lines, the internal areas of a combustion engine and other non-medical applications involving remote visualization of an area that benefits from remote access and assessment.

[0003] Endoscopes are high technology instruments, typically having advanced, expensive optical chips at the distal end of the scope to facilitate exceptional visualization. These imaging signals are captured on the chip and communicated in turn through high definition image transfer technology involving sophisticated software and imaging processing hardware that processes the optical signals. These signals in turn are translated and projected through the software and processor at numerous frames per second to an imaging screen, console, or other means of transmitting the image to a user distant from the optical chip.

[0004] The exceptional imaging capability of endoscopes has enabled numerous advances in medical and non-medical fields. This is due in significant part to the combination of excellent optical performance and scope handling joined to the reusable nature of nearly all endoscopes. This powerful combination allows for advanced, premium optical elements to be made available at a reasonable per use cost due to the ability to clean, disinfect and / or sterilize (as applicable) and reuse the endoscope with its advanced optical capability. The ability to reuse these scopes effectively spreads the high cost of the endoscope’s capability acrossInternational Patent ApplicationAttorney Docket No. : GI 099-PCT multiple procedures / uses, thereby enabling reasonable, low cost access to advanced technologies for multiple beneficial uses on a global basis. Endoscopes with these advanced optical capabilities are too expensive to be used once and discarded. In addition, the environmental impact of discarding the advanced electronics that facilitate the endoscope’s capability is considerable, unwarranted, and unsafe for the environment. Reusable scopes provide a way to make peak optical capability available for a variety of procedures where otherwise one would not be able to afford the cost to use such technology.

[0005] Even with the considerable advances and capabilities offered by reusable endoscopes, recent concerns have arisen regarding one’s ability to consistently and predictably clean and thereby remove all soil and biomatter that contaminates endoscopes during use. Successful cleaning is the critical step to support disinfection and / or sterilization (as applicable) to reprocess these scopes for their next use. Cleaning non-medical scopes is also important to avoid inhibiting scope performance with the next use because of retained matter that can accumulate and adversely impact scope performance. This applies to both non-robotic scopes and scopes connected to or otherwise used with robotic technology to use remote visualization to see, navigate and treat, as applicable. This also applies to other medical (and non-medical) devices having internal lumens that become contaminated.

[0006] Multiple contamination-related reprocessing issues leading to potential patient infections and / or scope performance issues have been noted with these scopes and other devices, such as endoscopic instruments, including shavers, and micro-comeal devices used in cataract surgery. These include issues with the cleanliness of reusable valves used to facilitate suction and air / water expression, the presence of residual matter that cannot be consistently removed from the complex distal end of certain scopes (especially duodenoscopes and endoscopic ultrasound scopes), and concerns regarding successful cleaning of the long biopsy / working channel(s) in certain scopes that are important for passing instruments to the distal end of the scope and other lumens.

[0007] Nearly all of these issues are addressable through the use of new, relatively low cost technologies and practices that have been created in response to these concerns and which can be applied in the context of current workflows and procedure economics, and which are environmentally friendly, especially when compared to single-use scope alternatives. These relatively low cost technologies and practices include the use of single-use disposable tubing and disposable valves instead of reusable tubing and valves, the use of sterile, single-useInternational Patent ApplicationAttorney Docket No. : GI 099-PCT endoscopic shields to seal the complex distal end of the scope during use and initial precleaning instead of leaving this area open and exposed to contamination, the use of forced-air drying, improved adherence to reprocessing approaches, and the implementation of postprocedure culturing and monitoring to address other areas of concern.

[0008] With all of these advances, an area that remains to be addressed is the cleaning and drying of the internal lumens of the endoscope and other medical and non-medical devices. During a medical procedure, the internal biopsy and suction channels become heavily contaminated with bacteria, biomatter and debris through the passing of multiple instruments through the biopsy channel and through the actuation of suction to remove mucus, debris and other matter that may obscure the physician’s visualization during the procedure. All of these activities benefit patients by delivering care through the scope in a less invasive manner but, in parallel, with these beneficial activities the scope experiences heavy contamination of these channels, which then must be cleaned completely to effectively return the scope to use for the next patient (or non-medical use) without exposing the next patient (or non-medical use or other lumen) to the risk of a scope-related infection or cross contamination (or a poor performing, unclean non-medical scope or other lumen-based device). It is well known that without successful cleaning, an endoscope cannot be disinfected or sterilized successfully. Unremoved biomatter and debris act as a shield for pathogens, protecting the pathogens from being killed by disinfectants and sterilants used to reprocess the scope. Additionally, unremoved biomatter, and pathogens create the opportunity for organisms to attach to surfaces inside the scope, engage in replication and form biofilm, which makes removal of these organisms particularly difficult and which, in turn, creates risk for the transmission of multidrug resistant infections through the scope. Biofilm can replicate, detach, and then attach in a new location and repeat this process, while also recruiting other organisms into the biofilm during the process, creating additional multi-drug resistant organisms (MDRO) that cannot be effectively treated with antibiotics. MDRO infections are exceptionally dangerous and have resulted in multiple deaths around the world from contaminated endoscopes that were not reprocessed successfully.

[0009] As shown by the Covid- 19 pandemic, the importance of successful cleaning becomes even more pronounced. It is now well documented that Covid-19 infections begin in the lungs, but quickly migrate to the gastrointestinal tract, with virus replication occurring in these organs prior to detectable symptoms. A significant number of endoscopic proceduresInternational Patent ApplicationAttorney Docket No. : GI 099-PCT involve the use of endoscopes, including by way of example, but not limitation, to examine and treat pulmonary conditions (e.g. bronchoscopies using a specialty endoscope called a bronchoscope), and to diagnose and treat conditions in the gastrointestinal tract (e.g. use of gastroscopes, duodenoscopes, endoscopic ultrasound scopes and colonoscopes), raising the potential that the Covid- 19 virus (or another pathogen) could become encapsulated in biofilm resulting from an incomplete cleaning of an endoscope and in turn progress to a drug resistant strain of Covid-19 (or another pathogen) that could be transmitted to subsequent patients. In view of all of these concerns, a new innovation is needed to notably improve the effectiveness and predictability of successful cleaning of the lumens of endoscopes.

[0010] Another limitation with current cleaning devices and systems (including AERs) is removing pre-existing biomatter or biofilms from the internal channels and valves of medical devices, such as endoscopes. Biofilms are a multilayered organized matrix of bacterial, fungal algal or protozoan cells held on a surface by a mesh of polysaccharides. When a bacterial biofilm begins to form, there is an initial attachment of bacteria to a surface. At this point, the attachment is generally reversible and can be removed with certain cleaning protocols. Failure to remove the initial reversible attachment of microorganisms, however, can eventually result in the attachment, colonization and establishment of a mature biofilm. Once the biofilm has attached, a protective layer of polysaccharides and proteins is secreted by the bacteria. This self-created barrier protects the bacteria from physical and chemical damage and causes the biofilm to be resistant to mechanical cleaning methods (e.g., brushing), high-level disinfection and sterilization as the uppermost layers of bacteria protect the layers underneath. Once a biofilm is established, parts of the biofilm matrix may periodically detach and enter a patient during clinical use of the device and pose an infection control risk.

[0011] Thus, a new innovation is needed that addresses the notable limitations of current technologies and that can actively complement and work-in-concert with cleaning fluids, detergents and water flushing to effectively clean or disinfect medical devices. In particular, it would be desirable to provide devices that can effectively remove pre-existing biomatter or biofilms that have formed on the external and internal surfaces of these devices.International Patent ApplicationAttorney Docket No. : GI 099-PCTSUMMARY

[0012] Systems, kits, devices and methods are provided for cleaning and / or drying medical devices, such as cataract and other eye surgery devices and / or endoscopic devices, such as endoscopes, particularly internal lumens, valves or other spaces within the endoscopic instruments, after they have been cleaned. The systems, kits, devices and methods are particularly useful for removing pre-existing biomatter and / or biofilms that have already formed on the external and internal surfaces of these devices.

[0013] The methods and devices disclosed herein may be used with, or may be incorporated into, a variety of different reusable, reprocessed or disposable endoscopic instruments and other medical devices or systems that include internal lumens or other internal spaces, such as endoscopes, trocars, cannulas, dilatation devices, suction devices, shavers, radiofrequency ablation devices, Coblation® devices, Foley catheters, cataract and other eye surgery devices, guidewires, central venous catheters, bipolar or monopolar electrosurgical or ultrasonic devices, ventilation machines, respirators, continuous positive airway pressure (CPAP) and other positive airway machines and components thereof, dialysis machines and components thereof, robotic and remote surgery equipment, including robotic manipulator arms, reusable robotic instruments, such as linear and circular stapling devices, clip appliers, forceps, scissors, needle holders, cutting instruments, retractors, suturing devices, clip appliers, and clamping, cutting, ligating, dissecting, clipping, cauterizing, suturing and / or sealing instruments, arterial lines, drainage catheters, peripherally inserted central catheters, endotracheal tubes, feeding tubes, and other devices that in-dwell, penetrate and / or navigate in the body. This also applies to other lumens and containers that need cleaning, drying, disinfection and / or sterilization, including lab test tubes, pathology equipment, drains, fluid and air transfer lines and similar lumens and containers that must be cleaned, and / or dried, and / or disinfected and / or sterilized.

[0014] In one aspect, a system for removing biomatter from a medical device comprises a source of enzymatic detergent and a cleaning device comprising an elongate member configured for advancement through a lumen within the medical device and at least one cleaning member coupled to a portion of the elongate member. The cleaning member comprises distal and proximal end portions and a central portion between the distal and proximal end portions, wherein the central portion is shaped to create a pressure gradient along the central portion from the distal end portion to the proximal end portion.International Patent ApplicationAttorney Docket No. : GI 099-PCT

[0015] The combination of the enzymatic detergent and the unique nature of the cleaning device is sufficient to remove pre-existing biomatter from the surfaces of the medical device, such as biomatter that has already formed into a biofilm (i.e., a multilayered organized matrix of bacterial, fungal algal or protozoan cells held on a surface by a mesh of polysaccharides). The detergent loosens the protective layer of polysaccharides and proteins of the biofilm and the cleaning device then removes both the protective layer and the underlying biomatter.

[0016] In embodiments, the enzymatic detergent comprises a material selected from the group consisting of proteases, hydrolases, amylases, lipases, cellulases, mannanases, pectinases and combinations thereof. The enzymatic detergent may comprise other components, such as protease inhibitors, surfactants and the like.

[0017] In certain embodiments, the system further comprises a fluid delivery device for delivering the enzymatic detergent, air or another cleaning fluid into the lumen of the medical device. The fluid delivery device may comprise, for example, a pump configured to deliver the enzymatic detergent, air or cleaning fluids under pressure. The device may further include a tube coupled to the pump and a connector or adaptor configured for coupling the tube to the channel of the medical device. The adaptor may comprise any suitable adaptor, such as one configured for coupling a tube or pulling elements to a valve of an endoscope, such as an air valve, water valve, biopsy valve, suction valve, or an opening to a working channel of the endoscope. In certain embodiments, the device may be disposed inside or outside of an automatic endoscope reprocessor (AER).

[0018] In other embodiments, the system comprises a housing having a basin for receiving the medical device. The basin is configured such that the medical device is substantially immersed within the enzymatic detergent.

[0019] In embodiments, the housing further comprises a connector for coupling a tube to a lumen of the medical device. The system further comprises a power source and a pump or other device for delivering the enzymatic detergent through the tube and the lumen of the medical device.

[0020] In embodiments, the enzymatic detergent is delivered into the lumen of the medical device and allowed to reside therein for a period of time, such as about one minute to about 60 minutes, or about one minute to about 10 minutes, or about 5 minutes to about 10Intemational Patent ApplicationAttorney Docket No. : GI 099-PCT minutes. The cleaning device is then delivered into the lumen to remove biomatter and biofilms from the internal surfaces of the lumen. The detergent loosens the protective layer of polysaccharides and proteins of the biofilm and the cleaning device then removes both the protective layer and the underlying biomatter.

[0021] In certain embodiments, the fluid delivery device is configured to deliver air, water, or a second cleaning fluid into the lumen, such as enzymatic cleaner, detergent or a ph- neutral non-enzymatic cleaner. In an exemplary embodiment, the second cleaning and / or disinfectant formulations comprise one or more of glutaraldehyde, thophthalaldehyde, peracetic acid, chlorine, hydrogen peroxide, phenol / phenate, alcohol, microbicidal agents or the like.

[0022] In another aspect, a method for removing biomatter or biofilm from a medical device comprises delivering an enzymatic detergent into a lumen of the medical device and advancing an elongate member of a cleaning device through the lumen within the medical device such that at least one cleaning member passes through the lumen in contact with an internal surface of the lumen. The cleaning member and the enzymatic detergent are sufficient to remove pre-existing biomatter and / or biofilms from the internal surface of the lumen.

[0023] In embodiments, the elongate member is advanced through the lumen after the enzymatic detergent has been delivered into the lumen. In an exemplary embodiment, the elongate member is advanced through the lumen about one minute to about 60 minutes, or about one minute to about 10 minutes, or about 5 minutes to about 10 minutes, after the enzymatic detergent has been delivered into the lumen. In an exemplary embodiment, air, water, or a second cleaning fluid is delivered into the lumen while the elongate member is advanced therethrough.

[0024] In embodiments, the enzymatic detergent comprises a material selected from the group consisting of proteases, hydrolases, amylases, lipases, cellulases, mannanases, pectinases and combinations thereof. The enzymatic detergent may comprise other components, such as protease inhibitors, surfactants and the like.

[0025] In embodiments, the elongate member of the cleaning device comprises a filament, wire, cable, robotic arm, tube, or other element capable of advancement, retraction or other movement into an internal channel, including a long, curved, or other channel that is difficult to access because it is recessed, variable or internal. In embodiments, this element canInternational Patent ApplicationAttorney Docket No. : GI 099-PCT be grasped at an end once it is pulled through the internal channel and then pulled through the channel as part of the cleaning process. It also can be advanced from the other end through pushing the advancement element.

[0026] In one embodiment, the cleaning member comprises distal and proximal end portions having at least a portion of a diameter substantially equal to or greater than an inner diameter of the lumen and a variable pressure central portion between the distal and proximal end portions. Alternatively, the proximal and distal end portions may have a diameter substantially less than an inner diameter of the lumen. The variable pressure central portion is shaped to create a pressure gradient along the central portion from the distal end portion to the proximal end portion. This pressure gradient causes an increase in a relative velocity between the cleaning member and the air, water or enzymatic detergent within the lumen as the cleaning member is advanced through the lumen. The increased velocity of the detergent increases the shear stress between the air or fluid and the lumen wall, thereby creating more force to clean the wall.

[0027] In certain embodiments, the central portion of the cleaning member comprises a contraction section coupled to the proximal end portion, a diffusion section coupled to the distal end portion and a throat section coupling the diffusion and contraction sections. The throat section has a diameter less than the diameter of the proximal and distal end portions and greater than a diameter of the diffusion and contraction sections.

[0028] The variable pressure region between the two cylindrical elements may include an inverted, partial venturi shape, a parabolic shape, a variable slope shape or such other shape that creates variable pressure between the two cylinders and the wall of the channel being cleaned, thereby increasing the force against the channel wall when the cleaning member is advanced. In an exemplary embodiment, the throat section is substantially cylindrical. The contraction section preferably increases in diameter from the proximal end portion to the throat section and the diffusion section preferably decreases in diameter from the throat section to the distal end portion, thereby creating a venturi effect between the distal and proximal end portions of the cleaning element.

[0029] In embodiments, the proximal and distal end portions of the cleaning member create consistent circumferential contact with the interior wall of an endoscope channel, such as a biopsy or suction channel. In certain embodiments, these channel contact elementsInternational Patent ApplicationAttorney Docket No. : GI 099-PCT preferably have a substantially circumferential, cylindrical or conical shape with at least one portion of the element having a diameter approximately equal to or slightly larger than the diameter of the internal lumen. In an exemplary embodiment, the diameter of the proximal and distal end portions is about 1 to about 1.5 times the diameter of the internal lumen, preferably about 1 to about 1.25 times this diameter. This avoids deflection of the proximal and distal end portions, thereby reducing the buckling and the creation of a gap between the cleaning element and the internal wall of the lumen.

[0030] In certain embodiments, the cleaning element includes more than one cleaning member. For example, in one such embodiment, the drying device includes 2-10 cleaning members, preferably 2-5 cleaning members. The cleaning members may be coupled to each other to provide a string of such cleaning members along the navigation element, or separated by various distances, to increase the effectiveness of the device. In these embodiments, for example, the proximal end portion of one cleaning member may be coupled to, or may be integral with, the distal end portion of the next cleaning member along the string. Each of the cleaning members comprises distal and proximal end portions having a diameter substantially equal to or greater than an inner diameter of the lumen and a central portion between the distal and proximal end portions. The central portion of each cleaning member is shaped to create a pressure gradient along the central portion from the distal end portion to the proximal end portion. The variable pressure elements in each cleaning member may be the same or may vary to create alternating pressure profiles. The multiple cylindrical elements with variable pressure elements between the cylindrical elements may be greater or less than five sets, as appropriate for the given application.

[0031] In various embodiments, the power source (or a second power source) is coupled to the cleaning device and configured to advance the cleaning member through one or more channel(s) of the endoscopic instrument to remove biomatter and biofilms from the inner walls of the channel. The power source may comprise, for example, a motor configured for coupling to the cleaning device and advancing the elongate member and the cleaning member through the channel of the endoscopic device. The motor may be configured to pull or push, or otherwise advance, retract or move, the elongate member through the channel.International Patent ApplicationAttorney Docket No. : GI 099-PCT

[0032] In various embodiments, the system comprises a controller, processor or the like coupled to the power source. The controller is configured to actuate the motor to advance the cleaning device through the endoscope channel to remove biomatter and biofilms from the channel.

[0033] In various embodiments, the power source comprises a motor or other nonhuman actuator configured for coupling to the cleaning device and advancing the elongate member and the cleaning member through the channel(s) of the endoscopic device to clean / remove debris. The motor may comprise any suitable motor, such as a stepper motor, DC motor, AC motor, servomotor, induction motor, magnetic motor, gear motor, linear motor, shunt motor, compound, or single phase motor, vacuum pump or other non-human actuator to advance or retract the cleaning device. The motor may be configured to pull or push the elongate member through the channel. In one embodiment, the motor comprising a moving internal waterjet that advanced the cleaning member(s) through the channels while delivering fluid therethrough. The water jet and / or the cleaning member may comprise a centering element.

[0034] In an exemplary embodiment, the motor is configured to advance the cleaning member through the lumen at a specific rate of speed, or a variable rate of speed. This ensures that the cleaning member moves at a velocity suitable for effectively removing biomatter and biofilms from the channels in the medical device.

[0035] In another aspect, a system for removing biomatter from a medical device comprises a source of enzymatic detergent, a fluid delivery device for delivering the enzymatic detergent into a lumen of the medical device and a pump having an outlet and configured to drive air through the outlet and into the lumen of medical device. The system may be used to remove biomatter and biofilms from any internal channel of a medical device and is particularly useful in removing such material from smaller channels, such endoscopic valves and the like, because it does not require the use of a cleaning device or brush that would otherwise be too large to advance into the channel or valve.

[0036] The combination of the enzymatic detergent and the unique nature of the air delivery from the pump is sufficient to remove pre-existing biomatter from the surfaces of the medical device, such as biomatter that has already formed into a biofilm (i.e., a multilayered organized matrix of bacterial, fungal algal or protozoan cells held on a surface by a mesh ofInternational Patent ApplicationAttorney Docket No. : GI 099-PCT polysaccharides). The detergent loosens the protective layer of polysaccharides and proteins of the biofilm and the air delivered by the pump then removes both the protective layer and the underlying biomatter.

[0037] In embodiments, the enzymatic detergent comprises a material selected from the group consisting of proteases, hydrolases, amylases, lipases, cellulases, mannanases, pectinases and combinations thereof. The enzymatic detergent may comprise other components, such as protease inhibitors, surfactants and the like.

[0038] In embodiments, the system further comprising a housing and the pump is disposed within the housing. In various embodiments, the pump is a pulsatile pump configured to drive the air through the outlet of the housing in pulses or waves. The pulses may have a frequency of about 10 Hz to about 120 Hz, or about 20 Hz to about 90 Hz, or about 40 Hz to about 75 Hz, or about 60 Hz. Applicant has discovered that delivering air in pulses through the endoscope channels results in more effective drying as the pulses of air break up and displace the water and moisture in the channel, particularly within small cracks, crevices, or other defects in the internal walls of the channel.

[0039] The pump may be configured to drive the air at a volumetric flow rate of about 5 to about 50 Liters / minutes, or about 10 to about 40 Liters / minute or about 15 to about 35 Liters / minute or about 20 to about 30 Liters / minute or about 24 Liters / minute. The pump may be configured to drive the air at a pressure (exciting the pump) between about 1 psi to about 25 psi, or between about 1 psi to about 20 psi, or between about 1 psi to about 15 psi, or between about 1 psi to about 10 psi, or between about 1 psi to about 5 psi, or between about 1 psi to about 4 psi, or about 2.9 psi or about 3.625 psi.

[0040] Applicant has discovered that driving the air at lower pressures in the ranges above and relatively high volumetric flow rates in the ranges above provides more effective and efficient drying of lumens. In particular, the lower pressure, relatively high volumetric flow rates of the air cause the air to literally displace substantially all of the water or moisture within the lumen to the opposite end of the lumen to exit the lumen, thereby drying the lumen. Thus, the majority of the “drying action” comes from displacement, rather than evaporation.

[0041] In addition, applicant has discovered driving the air at lower pressures in the ranges above and volumetric flow rates in the ranges above results in much faster drying times than conventional devices and systems. In embodiments, the drying systems described hereinInternational Patent ApplicationAttorney Docket No. : GI 099-PCT are capable of substantially removing all moisture and water from a lumen in less than about 5 minutes, or less than about 3 minutes, or less than about 2 minutes, or in some cases, less than about 1 minute or less than 30 seconds. In an exemplary embodiment, some channels may be substantially dried in about 20 seconds.

[0042] In embodiments, the drying system has a sound level during operation of less than about 60 decibels, or less than about 50 decibels, or less than about 40 decibels, or between about 20 decibels to about 35 decibels or about 30 decibels. The lower sound levels of the drying system provide significant advantages to health care professionals given that sustained levels of sound between about 60 to about 70 decibels can cause long term hearing loss.

[0043] In another aspect, a method for removing biomatter from a medical device comprises delivering air through a lumen of the medical device sufficient to dry the lumen and delivering an enzymatic detergent into the lumen of the medical device. In embodiments, the enzymatic detergent comprises a material selected from the group consisting of proteases, amylases, lipases, cellulases, mannanases and combinations thereof.

[0044] In embodiments, the method further comprises flushing the lumen of the enzymatic detergent and then delivering air through a lumen of the medical device sufficient to dry the lumen.

[0045] In embodiments, the lumen comprises a valve of an endoscope.

[0046] In embodiments, the air is delivered to the lumen for about one minute to about 60 minutes, or about one minute to about 10 minutes, or about five minutes to about 10 minutes.

[0047] In embodiments, the air is delivered in pulses having a frequency of about 10 Hz to about 120 Hz, or about 20 Hz to about 90 Hz, or about 40 Hz to about 75 Hz, or about 60 Hz. In embodiments, the air is driven at a volumetric flow rate of about 5 to about 50 Liters / minutes, or about 10 to about 40 Liters / minute or about 15 to about 35 Liters / minute or about 20 to about 30 Liters / minute or about 24 Liters / minute. In embodiments, the air is delivered at a pressure (exiting the pump) between about 1 psi to about 25 psi, or between about 1 psi to about 20 psi, or between about 1 psi to about 15 psi, or between about 1 psi to about 10 psi, or between about 1 psi to about 5 psi, or between about 1 psi to about 4 psi, or about 2.9 psi or about 3.625 psi.International Patent ApplicationAttorney Docket No. : GI 099-PCT

[0048] In another aspect, an automated cleaning and / or drying system for an endoscopic device comprises a source of enzymatic detergent and a cleaning and / or drying device comprising an elongate member configured for advancement through a lumen within the endoscopic instrument and at least one drying member coupled to a portion of the elongate member. The system further comprises a power source coupled to the cleaning / drying device and configured to advance the cleaning / drying member through the lumen of the endoscopic device.

[0049] In various embodiments, the elongate member and / or the cleaning / drying member(s) may be configured to be reusable or disposable. The cleaning / drying member(s) may comprise a variable pressure device (as described below), a squeegee, wire, sponge, balls, brushes, an elastic material, spiral or auger shaped cleaning device or another absorbent and / or displacing device. The cleaning / drying member may also include a centering device, such as one of the devices described below or another centering device, such as offsetting lateral fins or the like.

[0050] In various embodiments, the power source comprises a motor or other nonhuman actuator configured for coupling to the cleaning device and advancing the elongate member and the cleaning and / or drying member through the channel(s) of the endoscopic device to clean / remove biomatter and biofilms. The motor may comprise any suitable motor, such as a stepper motor, DC motor, AC motor, servomotor, induction motor, magnetic motor, gear motor, linear motor, shunt motor, compound, or single phase motor, vacuum pump or other non-human actuator to advance or retract the cleaning and / or drying device. The motor may be configured to pull or push the elongate member through the channel.

[0051] In an exemplary embodiment, the motor is configured to advance the cleaning / drying member through the lumen at a specific rate of speed and / or at a specific sequence, such as a variance followed by a specific rate of speed. This ensures that the cleaning and / or drying member moves at a velocity suitable for effectively removing moisture, debris, biomatter, biofilms or other contaminants from the channels in an endoscope

[0052] In various embodiments, the system further comprises a fluid delivery device configured to deliver the enzymatic detergent, air or other cleaning fluids through the lumen of the medical device. The fluid delivery device may comprise a pump for delivering the fluid under pressure through the channel of the medical device. The device may further include aInternational Patent ApplicationAttorney Docket No. : GI 099-PCT tube coupled to the pump and a connector or adaptor configured for coupling the tube to the channel of the endoscopic device. The adaptor may comprise any suitable adaptor, such as one configured for coupling a tube to a valve of an endoscope, such as an air valve, water valve, biopsy valve, suction valve, or an opening to a working channel of the endoscope.

[0053] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the description. Additional features of the description will be set forth in part in the description which follows or may be learned by practice of the description.BRIEF DESCRIPTION OF THE DRAWINGS

[0054] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several embodiments of the description and together with the description, serve to explain the principles of the description.

[0055] FIG. 1 illustrates a cleaning and / or drying system;

[0056] FIG. 2 illustrates a cleaning and / or drying device of the system of FIG. 1;

[0057] FIG. 3 A is a perspective view of an endoscope coupling element for the cleaning and / or drying system of FIG. 1;

[0058] FIGS. 3B-3D are perspective view of another embodiment of an endoscope coupling element for the cleaning and / or drying system of FIG. 1;

[0059] FIG. 4 is a perspective view of a powered dryer for the cleaning and / or drying system of FIG. 1;

[0060] FIG. 5 illustrates a connector element for the powered dryer of FIG. 4;

[0061] FIG. 6 illustrates a representative endoscope with internal channels to be cleaned and / or dried by the system of FIG. 1;

[0062] FIG. 7 illustrates a step of connecting the connector element of FIG. 5 to the powered dryer of FIG. 4;International Patent ApplicationAttorney Docket No. : GI 099-PCT

[0063] FIG. 8 illustrates a step of connecting the connector element of FIG. 5 to the endoscope coupling element of FIG. 3;

[0064] FIGS. 9A and 9B illustrate the step of securing the endoscope coupling element to an endoscope;

[0065] FIGS. 10A and 10B illustrate the step of advancing the cleaning and / or drying device of FIG. 2 through one of the internal channels of the endoscope;

[0066] FIG. 11 illustrates the powered dryer of FIG. 4 drying one of the internal channels of the endoscope;

[0067] FIG. 12 illustrates a connection point of a representative auxiliary water channel of an endoscope;

[0068] FIG. 13 illustrates the endoscope coupling element coupled to the auxiliary water channel of FIG. 12;

[0069] FIG. 14 is a perspective view of the cleaning and / or drying element of FIG. 2 exiting an internal lumen in an endoscope;

[0070] FIG. 15 is a side view of an exemplary embodiment of the cleaning and / or drying element of FIG. 2;

[0071] FIG. 16A is a side view of another embodiment of a cleaning and / or drying element;

[0072] FIG. 16B is a side of view of another embodiment of a cleaning and / or drying element;

[0073] FIG. 17 illustrates the “drying air jet” action of the cleaning and / or drying element of FIG. 15;

[0074] FIG. 18 illustrates the “suction” action of the cleaning and / or drying element of FIG. 15;

[0075] FIG. 19 illustrates the “sweep” action of the cleaning and / or drying element of FIG. 15;International Patent ApplicationAttorney Docket No. : GI 099-PCT

[0076] FIG. 20 illustrates the “scrub” action of the cleaning and / or drying element of FIG. 15.

[0077] FIG. 21 illustrates a representative automated endoscope reprocessing (AER) system;

[0078] FIG. 22 is a top view of the AER system of FIG. 21;

[0079] FIG. 23 is a side view of the AER system of FIG. 21;

[0080] FIG. 24 illustrates a connection diagram for a representative endoscope with the AER system of FIG. 21;

[0081] FIG. 25 illustrates the representative endoscope positioned within a basin of the AER system;

[0082] FIGS. 26-29 schematically illustrate different methods of cleaning the internal channels of an endoscopic device with the cleaning devices described herein and an AER system; and

[0083] FIGS. 30 and 31 illustrate the calculation of drying time for air delivered through a channel or lumen.DESCRIPTION OF THE EMBODIMENTS

[0084] This description and the accompanying drawings illustrate exemplary embodiments and should not be taken as limiting, with the claims defining the scope of the present description, including equivalents. Various mechanical, compositional, structural, and operational changes may be made without departing from the scope of this description and the claims, including equivalents. In some instances, well-known structures and techniques have not been shown or described in detail so as not to obscure the description. Like numbers in two or more figures represent the same or similar elements. Furthermore, elements and their associated aspects that are described in detail with reference to one embodiment may, whenever practical, be included in other embodiments in which they are not specifically shown or described. For example, if an element is described in detail with reference to one embodiment and is not described with reference to a second embodiment, the element may nevertheless beInternational Patent ApplicationAttorney Docket No. : GI 099-PCT claimed as included in the second embodiment. Moreover, the depictions herein are for illustrative purposes only and do not necessarily reflect the actual shape, size, or dimensions of the system or illustrated components.

[0085] It is noted that, as used in this specification and the appended claims, the singular forms “a,” “an,” and “the,” and any singular use of any word, include plural referents unless expressly and unequivocally limited to one referent. As used herein, the term “include” and its grammatical variants are intended to be non-limiting, such that recitation of items in a list is not to the exclusion of other like items that can be substituted or added to the listed items.

[0086] Systems, kits, devices and methods are provided for cleaning and / or drying medical devices, such as cataract and other eye surgery devices and / or endoscopic devices, such as endoscopes, particularly internal lumens, valves or other spaces within the endoscopic instruments, after they have been cleaned. The systems, kits, devices and methods are particularly useful for removing pre-existing biomatter and / or biofilms that have already formed on the external and internal surfaces of these devices.

[0087] While the following description is primarily directed to an endoscope and a device for cleaning and / or drying the endoscope, it should be understood that the features of the presently described disinfection system may be readily adapted for use with a variety of different reusable, reprocessed or disposable endoscopic instruments and other medical devices or systems that include internal lumens or other internal spaces, such as endoscopes, trocars, cannulas, dilatation devices, suction devices, shavers, radiofrequency ablation devices, Coblation® devices, Foley catheters, cataract and other eye surgery devices, guidewires, central venous catheters, bipolar or monopolar electrosurgical or ultrasonic devices, ventilation machines, respirators, continuous positive airway pressure (CPAP) and other positive airway machines and components thereof, dialysis machines and components thereof, robotic and remote surgery equipment, including robotic manipulator arms, reusable robotic instruments, such as linear and circular stapling devices, clip appliers, forceps, scissors, needle holders, cutting instruments, retractors, suturing devices, clip appliers, and clamping, cutting, ligating, dissecting, clipping, cauterizing, suturing and / or sealing instruments, arterial lines, drainage catheters, peripherally inserted central catheters, endotracheal tubes, feeding tubes, and other devices that in-dwell, penetrate and / or navigate in the body, as well as non-medical applications.International Patent ApplicationAttorney Docket No. : GI 099-PCT

[0088] The term “endoscope” as used herein refers generally to any scope used on or in a medical application, which includes a body (human or otherwise) and includes, for example, a laparoscope, arthroscope, colonoscope, gastroscope, duodenoscope, endoscopic ultrasound scope, cholangioscope, bronchoscopes, enteroscope, cystoscope, laparoscope, laryngoscope, sigmoidoscope, thoracoscope, cardioscope, and saphenous vein harvester with a scope, whether robotic or non-robotic, or in a non-medical application.

[0089] When engaged in remote visualization inside the patient’s body, a variety of scopes are used. The scope used depends on the degree to which the physician needs to navigate into the body, the type of surgical instruments used in the procedure and the level of invasiveness that is appropriate for the type of procedure. For example, visualization inside the gastrointestinal tract may involve the use of endoscopy in the form of flexible gastroscopes and colonoscopes and specialty duodenum and ultrasound scopes with lengths that can run many feet and diameters that can exceed 1 centimeter. These scopes can be turned and articulated or steered by the physician as the scope is navigated through the patient. Many of these scopes include one or more working channels for passing and supporting instruments, fluid channels and washing channels for irrigating the tissue and washing the scope, insufflation channels for insufflating to improve navigation and visualization and one or more light guides for illuminating the field of view of the scope.

[0090] Smaller and less flexible or rigid scopes, or scopes with a combination of flexibility and rigidity, are also used in medical applications. For example, a smaller, narrower, and much shorter scope is used when inspecting a joint and performing arthroscopic surgery, such as surgery on the shoulder or knee. When a surgeon is repairing a meniscal tear in the knee using arthroscopic surgery, a shorter, smaller diameter and more rigid scope is usually inserted through a small incision on one side of the knee to visualize the injury, while instruments are passed through incisions on the opposite side of the knee. The instruments can irrigate the scope inside the knee to maintain visualization and to manipulate the tissue to complete the repair

[0091] Other scopes may be used for diagnosis and treatment using less invasive endoscopic procedures, including, by way of example, but not limitation, the use of scopes to inspect and treat conditions in the lung (bronchoscopes), mouth (enteroscope), urethra (cystoscope), abdomen and peritoneal cavity (laparoscope), nose and sinus (laryngoscope), anus (sigmoidoscope) and other aspects of the gastrointestinal tract (gastroscope,International Patent ApplicationAttorney Docket No. : GI 099-PCT duodenoscope, endoscopic ultrasound scope, colonoscope), chest and thoracic cavity (thoracoscope), and the heart (cardioscope). In addition, robotic medical devices rely on scopes for remote visualization of the areas the robotic device is assessing and treating.

[0092] These and other scopes may be inserted through natural orifices (such as the mouth, sinus, ear, urethra, anus, and vagina) and through incisions and port-based openings in the patient’s skin, cavity, skull, joint, or other medically indicated points of entry. Examples of the diagnostic use of endoscopy with visualization using these medical scopes includes investigating the symptoms of disease, such as maladies of the digestive system (for example, nausea, vomiting, abdominal pain, gastrointestinal bleeding), or confirming a diagnosis, (for example by performing a biopsy for anemia, bleeding, inflammation, and cancer) or surgical treatment of the disease (such as removal of a ruptured appendix or cautery of an endogastric bleed).

[0093] Referring now to FIG. 1, a drying system 10 comprises a cleaning and / or drying device 200, a powered dryer 30, a connector element 40 and an endoscope coupling device 50. Cleaning and / or drying device 200 comprises a sterile, direct-to-channel drying apparatus that may be used to rapidly dry or clean internal lumens or channels of endoscopic devices, such as the instrument channels and / or the suction / air channels of an endoscope. Powered dryer 30 comprises a compact power source for delivering air through the internal channels and is particularly useful for smaller or micro-channels within an endoscopic device. The connector element 40 comprises a filtered air tubing set for connecting powered dryer 30 with endoscope coupling device 50. Endoscope coupling device 50 comprises a universal connector for securing connector element 40 to multiple different internal channels of commercial endoscopes, including, but not limited to, the Olympus TJF-Q1180V and 190V duodenoscopes, Pentax ED-3490 and ED 34i-10t2 duodenoscopes, Fuji ED-580XT, ED- 530XT and EG38-J1OUT, Olympus CF-HQ190L / I colonoscope, Olympus GF-UCT180 endoscopic ultrasound scope, Pentax EC34-ilOL, EC38-il0L, EG34-H0, EG38-J10UT, EC 3890Li, EC3890Zi, G-EYE38-H0F2, G-EYE38-H0L / F, G-EYE34H0L / F, Fuji EG 580UT, G- EYE 760S-VL-5E, GEYE 760RVL5E, EG760CT, EC760R-V / L, EC760S-V / L, EC760Z-V / L and EI-740DS, Olympus PCF-H190L / I, PCF-H190L / I Pediatric Colonoscope, and BF-XT190 Bronchoscope, Pentax EG29H0, ED32H0 and EC34Tli, EC34-H0TL, EC34-H0TF, EC34- ilOT, Fuji G-EYE760PVL-5E, EC760P-V / L, EC7602P V / L, EN580T, EI-580BT, EC740 T / L and EI-740 D / S, Olympus GIF-HQ190 and GIF-H190 Gastroscopes, SIF-Q180, GF-UC140P-International Patent ApplicationAttorney Docket No. : GI 099-PCTAL5 Endoscopic Ultrasound Scope and BF-1TH190 Bronchoscope, Pentax EG2990Zi, EG34- J10U, EC2990Li, EG27-ilO and EB19-J10, Fuji EG760R, EG760Z, EB580T and EG580UR, Olympus CYF-5 Cystoscope, Pentax EG36J10UR, Fuji EG740N, Olympus GF UE160-AL5, GIF-XP190N, CYF-VH, CYF-V2, Fuji EB580S, Olympus BF-H190, BF-Q190, and BF-P190 Bronchoscopes, Pentax EG1690K, EG16-K10, EB15-J10, VNL-1570STK, Fuji, EB-530H, EB-530US, Olympus BF-MP190F, Olympus BF-XP190, Fuji EB530P and others.

[0094] As shown in FIG. 2, cleaning and / or drying device 200 comprises an elongate tube or filament 22 having an insertion end 24 and a cleaning and / or drying element 300 on the opposite end of filament 22 from insertion end 24. Certain preferred embodiments of cleaning and / or drying element 300 are discussed below in reference to FIGS. 14-21. Filament 22 preferably comprises a material with sufficient flexibility to advance through an internal endoscope channel, while having sufficient rigidity to allow an operator to advance or withdraw insertion end 24 therethrough (see FIGS. 10A and 10B discussed in more detail below). In an alternative embodiment, system 10 may include an energy source and a motor for advancing and / or withdrawing filament 22. Filament 22 has an outer diameter sized to fit within, and translate through, the internal lumens in the endoscope. In the exemplary embodiment, filament 22 will have an outer diameter in the range of about 0.5 to about 5 mm, preferably about 1 to 4 mm. The drying element 300 could be, in embodiments, a variable pressure device or a squeegee, wire, sponge, balls or other absorbent or displacing device to remove moisture.

[0095] Referring now to FIG. 3A, endoscope coupling device 50 comprises a handle 100, a strap 110 and a coupling mechanism for coupling a distal end 112 of strap 110 to handle 100 (see FIG. 9B). Handle 100 may comprise any suitable shape that facilitates gripping by the user. In the exemplary embodiment, handle 100 comprises a substantially cylindrical main body 0 having gripping elements 104 surrounding at least a portion of the outer surface of body 102, although it will be understood that other configurations are envisioned. Handle 100 further includes a connector 106 for coupling device 50 to connector element 40, and a protrusion 108 extending from main body 102 sized to extend through one of the openings 109 on strap 110.

[0096] As shown, strap 110 may include a plurality of openings 109 that allow strap 110 to be attached to handle 100 to form a loop that fits around a portion of an endoscope (see FIG. 9B). Strap 110 preferably comprises an elastic material that allows the user to pull strapInternational Patent ApplicationAttorney Docket No. : GI 099-PCT110 around the body of the endoscope to secure device 50 to the endoscope. The elastic material is configured to provide sufficient tension to ensure that the nozzle is firmly seated into an opening of the endoscope, such as a valve or port. The one or more openings 109 may be positioned on strap 110 to form a variety of different circumferential lengths of strap 110 for coupling device 50 to different portions of the endoscope, or to endoscopes having different sizes. In the exemplary embodiment, strap 110 comprises two openings 109 spaced longitudinally from each other on distal end 113 of strap 110, although other configurations are envisioned. For example, strap 110 may include three or more openings, and the openings may be spaced laterally and / or longitudinal away from each other.

[0097] Handle 100 further includes a nozzle 112 extending from main body 102 (see FIG. 9 A) that is configured for coupling to an opening of a lumen in an endoscope, such as the air / water valve opening, suction opening or instrument port (discussed below in reference to FIG. 6). Handle 110 includes an internal lumen (not shown) fluidly coupling connector 106 with nozzle 112 to allow for air to be delivered through device 50 and into one of the endoscope lumens (discussed below).

[0098] Referring now to FIGS. 3B-3D, an alternative embodiment of an endoscope coupling device 50A comprises a handle 100, a strap 110 and a coupling mechanism for coupling a distal end 113 of strap 110 to handle 100 (see FIG. 9B). Handle 100 may comprise any suitable shape that facilitates gripping by the user. In the exemplary embodiment, handle 100 comprises a substantially cylindrical main body 102 having gripping elements 104 surrounding at least a portion of the outer surface of body 102, although it will be understood that other configurations are envisioned. Handle 100 further includes a connector 178 for coupling device 50A to connector element 40, and a protrusion 108 extending from main body 102 sized to extend through one of the openings 109 on strap 110.

[0099] As shown, strap 110 may include a plurality of openings 109 that allow strap 110 to be attached to handle 100 to form a loop that fits around a portion of an endoscope (see FIG. 9B). Strap 110 preferably comprises an elastic material that allows the user to pull strap 110 around the body of the endoscope to secure device 50 to the endoscope. The elastic material is configured to provide sufficient tension to ensure that nozzle 180 is firmly seated into an opening of the endoscope, such as a valve or port. The one or more openings 109 may be positioned on strap 110 to form a variety of different circumferential lengths of strap 110 for coupling device 50 to different portions of the endoscope, or to endoscopes having differentInternational Patent ApplicationAttorney Docket No. : GI 099-PCT sizes. In the exemplary embodiment, strap 110 comprises four openings 109 spaced longitudinally from each other on distal end 113 of strap 110, although other configurations are envisioned. For example, strap 110 may include two openings, three openings or five or more openings; and the openings 109 may be spaced laterally and / or longitudinal away from each other.

[0100] Handle 100 further includes a nozzle 180 extending from main body 102 (see FIG. 3D) on the opposite side of connector 178 having a mating feature configured for coupling to an opening of a lumen in an endoscope, such as the air / water valve opening, suction opening or instrument port (discussed below in reference to FIG. 6). Handle 100 includes an internal lumen (not shown) fluidly coupling connector 178 with nozzle 180 to allow for air to be delivered through device 50 and into one of the endoscope lumens (discussed below).

[0101] In some cases, the opening to an endoscope valve and / or a lumen of an endoscopic device may have a different configuration and / or diameter than the mating feature of nozzle 180. In such cases, nozzle 180 may not sufficiently mate with this opening or valve. To that end, device 50A further comprising a connector extension or adaptor 170 that includes a tube 172 coupling handle 100 with a second connector 176. Second connector 176 has a first end 174 configured for coupling to nozzle 180 and a second end 182 comprising a second mating feature functions as a nozzle for coupling to an opening of a lumen in an endoscope, such as the air / water valve opening, suction opening or instrument port. The second mating feature on nozzle 182 preferably has as different configuration and / or size as the first mating feature on nozzle 180.

[0102] In use, in the event that nozzle 180 does not fit a particular connection on an endoscopic device, connector extension 170 can be used by simply coupling first end 174 of second connector 176 to nozzle 180 and then coupling the second nozzle 182 to the opening or valve. Tube 172 is flexible enough to allow second connector 176 to be moved into position to accomplish this connection. This increases the overall versatility of device 50A such that the drying system can be used with a large variety of different internal channels and valves of commercial endoscopes and endoscopic devices, such as those described above.

[0103] Referring now to FIG. 4, powered dryer 30 comprises a pulsatile pump (not shown) for delivering air to channels within the endoscope. The pump delivers air through the internal channels at a specific volumetric flow rate to ensure that the air has sufficient pressureInternational Patent ApplicationAttorney Docket No. : GI 099-PCT within these channels to remove all or substantially all of the moisture therein. In various embodiments, the pulses may have a frequency of about 10 Hz to about 120 Hz, or about 20 Hz to about 90 Hz, or about 40 Hz to about 75 Hz, or about 60 Hz. The pump may be configured to drive the air at a volumetric flow rate of about 5 to about 50 Liters / minutes, or about 10 to about 40 Liters / minute or about 15 to about 35 Liters / minute or about 20 to about 30 Liters / minute or about 24 Liters / minute. The pump may be configured to drive the air at a pressure (exciting the pump) between about 1 psi to about 25 psi, or between about 1 psi to about 20 psi, or between about 1 psi to about 15 psi, or between about 1 psi to about 10 psi, or between about 1 psi to about 5 psi, or between about 1 psi to about 4 psi, or about 2.9 psi or about 3.625 psi. In embodiments, powered dryer 30 has a sound level during operation of less than about 60 decibels, or less than about 50 decibels, or less than about 40 decibels, or between about 20 decibels to about 35 decibels or about 30 decibels.

[0104] Applicant has discovered that driving the air at lower pressures in the ranges above and volumetric flow rates in the ranges above provides more effective and efficient drying of lumens. In particular, the lower pressure, relatively high volumetric flow rates of the air cause the air to literally displace substantially all of the water or moisture within the lumen to the opposite end of the lumen to exit the lumen, thereby drying the lumen. Thus, the majority of the “drying action” comes from displacement, rather than evaporation.

[0105] In addition, Applicant has discovered driving the air at lower pressures in the ranges above and volumetric flow rates in the ranges above results in much faster drying times than conventional devices and systems. In embodiments, the drying systems described herein are capable of substantially removing all moisture and water from a lumen in less than about 5 minutes, or less than about 3 minutes, or less than about 2 minutes, or in some cases, less than about 1 minute.

[0106] Through testing on actual endoscope lumens and other medical devices and instruments with lumens, Applicant observed that the drying of these lumens occurs much faster if the approach uses an air pump with lower pressure and a higher volume of air compared to pumps with higher pressure and lower air volume. Drying times were substantially shorter with this approach compared to published approaches that used higher pressure and lower volume in the same lumen or equivalent.International Patent ApplicationAttorney Docket No. : GI 099-PCT

[0107] Applicant also observed that current drying approaches not only use higher pressure (psi) for their air flow than the approach used by powered dryer 30 described herein, but the current approaches also divide the air delivered using a tubing set, such that the air flow is divided into multiple lumens (three, four or even five lumens) depending on the type of endoscope or instrument in which the drying is attempted. The observation with this approach is that the high PSI used with this approach would still apply to each lumen, but the air volume would be divided by three, four or five, reducing the drying effectiveness even further.

[0108] One of the performance objectives identified from this testing is drying is more rapid and effective if the volume of air advanced into and through a wet or moist lumen is maximized, while making sure there is still air pressure sufficient to overcome the adhesion forces of water, alcohol or other fluid in the lumen, so that the air pressure can advance the volume of air forward through the lumen to dry. This pressure must be sufficient to move the volume of air forward to engage with this fluid and moisture and advance the fluid and moisture forward and out of the lumen, as well as to cause evaporation of this fluid and moisture, as well.

[0109] The application of pressure must also be delivered to address these performance objectives without creating meaningful back pressure, which points toward using lower pressure and higher volume to achieve these results. Because endoscopes have highly complex lumen shapes, including double S-curves with variable diameters and Y junctions with multiple angles and wide-ranging diameters that can vary by over four to five hundred percent in diameter (from 2.2. mm to 11 mm cross only four to five centimeters of distance in these junctions), delivering high pressure air and lower volume air appears to result in less effective drying because of back pressure that results in less air entering and flowing uniformly through these complex lumens, resulting in drying failures or elongated drying times.

[0110] This performance appears to be explained, at least in part, by a proprietary application of certain principles from Fick’s law and convective mass transfer theory. The calculation based on these theories showed that the water mass transfer rate from a lumen is proportional to the cubic square root of the air volume flow rate through the lumen (see FIGS. 28 and 29). As a result, there is an inverse relationship between the drying time and the cubic square root of the air volume flow rate. This relationship is confirmed by data from tests performed with a number of different pumps available in the market. Although actual air volume flow rate through the lumen is determined by the pump performance curve and theInternational Patent ApplicationAttorney Docket No. : GI 099-PCT pressure loading (back pressure), the present theoretical and testing analysis support the fact that, in general, the drying performance can be enhanced with higher air volume pumps.

[0111] An additional observation is that the delivery of air volume and pressure with micropulsation further enhances drying. In a preferred embodiment, Applicant tested the approaches described herein to dry channels ranging in diameter from .9 mm to 1.4 mm. The powered dryer 30 used delivered air in a pulsatile manner in which the pump motor cycled at 60 HZ.

[0112] In testing on an Olympus 190 colonoscope air / water channel, the channel diameter was 1 mm and the channel had two lengths that connected to an air water valve. The length off one side of the air water valve (from the air / water bottle connector to the valve) was 60 inches. The length from the other side of the valve to the distal end of the scope was 77 inches.

[0113] Drying of a wet channel was rapidly achieved by connection of the powered dryer 30 to the air / water valve and delivering air using a 60 HZ pump that delivered air volume of 24 NL / minute (i.e. normal liters) and a maximum air pressure of 25 kPa (about 3.625 psi). The channel was dried with this approach in 20 seconds.

[0114] The pump may include a timing module that monitors the time period the pump is activated to delivery air. The pump may also be set (automatically or manually) with a preset drying cycle such that it delivers air for a period of time, such as about 10 seconds to about 5 minutes, or about 20 seconds to about 3 minutes, or about 30 seconds to about 2 minutes or about 45 seconds.

[0115] Powered dryer 30 is configured to deliver a pulsatile flow of air, preferably at a frequency of about 10 Hz to about 120 Hz, or about 20 Hz to about 90 Hz, or about 40 Hz to about 75 Hz, or about 60 Hz. In addition, to using lower pressure and higher volumetric flow rate of air, applicant has discovered that delivering air in pulses through the channel results in more effective drying as the pulses of air break up and displace the water and moisture in the channel, particularly within small cracks, crevices, or other defects in the internal walls of the channel.International Patent ApplicationAttorney Docket No. : GI 099-PCT

[0116] The pump within dryer 30 may comprise any suitable pump for delivering the air in pulses, such as an axial pump, centrifugal pump, rotary pump, positive displacement pump (e.g., piston, lobe, peristaltic, gear, diaphragm, or the like), hydraulic pump, magnetic drive pump, propeller pump, screw pump, vacuum pump, or combinations thereof.

[0117] Powered dryer 30 comprises a housing 32 with a connector 34 for coupling dryer 30 to connector 40 (see FIG. 7). Connector 34 may include a one-way valve (not shown) for ensuring unidirectional flow of air through connector 34 and into the endoscope. Housing 32 further includes a user interface 36 that may include, for example, a power button, a speed button for controlling the frequency of pulsating air and / or a timing button for setting the drying cycle.

[0118] Referring now to FIG. 5, connector 40 comprises an elongate flexible tubing 42 having a first connector end 44 for coupling to connector 34 of powered dryer 30 and a second connector end 46 for coupling to connector 106 of endoscope coupling device 50. Connector 40 further includes an internal lumen fluidly coupling the two ends such that air may be passed through from powered dryer 30 to the endoscope. In some embodiments, connector 40 further comprise an air filter 48, such as a pleated mechanical air filter (e.g., HEPA filter) for filtering contaminants from the air before it passes into the endoscope lumens.

[0119] In use, cleaning and / or drying system 10 is particularly useful for rapidly cleaning and dying the internal channels of endoscopes, particularly, the smaller or microchannels within endoscopes. As shown in FIG. 6, a representative endoscope 120 includes a proximal handle 122 adapted for manipulation by the surgeon or clinician coupled to an elongate shaft 124 adapted for insertion through an endoscopic or percutaneous penetration into a body cavity of a patient. Endoscope 120 may further include a fluid delivery system (not shown) coupled to handle 122 via, for example, a universal cord. The fluid delivery system may include several different tubes coupled to internal lumens within shaft 124 for delivery of fluid(s), such as enzymatic detergent, water and air, suction, and other features that may be desired by the clinician to displace fluid, blood, debris, and particulate matter from the field of view. This provides a better view of the underlying tissue or matter for assessment and therapy. In the representative embodiment, the fluid delivery system includes a water-jet connector, water bottle connector, a suction connector 134 and an air pipe.International Patent ApplicationAttorney Docket No. : GI 099-PCT

[0120] Proximal handle 122 may include a variety of controls for the surgeon or clinician to operate the fluid delivery system. In the representative embodiment, handle 122 include a suction valve 126, and air / water valve 128 and an instrument port 130 for delivering one or more instruments through shaft 124 to the surgical site. A suction channel 132 extends from suction valve 126 to suction connector 134, where it creates a relatively tight turn or bend 136 through handle 122. An air channel 140 extends from air / water valve 128 to a distal end 142 of endoscope 120 and an instrument channel 144 extends from instrument port 140 to distal end 142 of endoscope 120. In some cases, instrument channel 144 and air channel 140 may overlap and form the same channel through a portion of shaft 124.

[0121] The instrument channel 144 permits passage of instruments down the shaft 124 of endoscope 120 for diagnosing and treating patient conditions, including tissue and stone removal. Instrument channel 144 may also function as a working channel for other instruments to pass through endoscope 120 for assessment and treatment of tissue and other matter. Such instruments may include cannulas, catheters, stents, and stent delivery systems, papillotomes, wires, other imaging devices including mini-scopes, baskets, snares, and other devices for use with a scope in a lumen. Alternatively, endoscope 120 may include a separate working channel or a dual working channel for these instruments.

[0122] Referring now to FIGS. 7-13, a method for removing biomatter or biofilms from one or more of the internal channels of endoscope 120 will now be described. The combination of the enzymatic detergent and the unique nature of the air delivery from the pump is sufficient to remove pre-existing biomatter from the surfaces of the medical device, such as biomatter that has already formed into a biofilm (i.e., a multilayered organized matrix of bacterial, fungal algal or protozoan cells held on a surface by a mesh of polysaccharides). The detergent loosens the protective layer of polysaccharides and proteins of the biofilm and the air delivered by the pump then removes both the protective layer and the underlying biomatter.

[0123] The enzymatic detergent comprises a material selected from the group consisting of proteases, hydrolases, amylases, lipases, cellulases, mannanases, pectinases and combinations thereof. The enzymatic detergent may comprise other components, such as protease inhibitors, surfactants and the like.International Patent ApplicationAttorney Docket No. : GI 099-PCT

[0124] The method may further comprises flushing the lumen of the enzymatic detergent and then delivering air through a lumen of the medical device sufficient to dry the lumen. In embodiments, the lumen comprises a valve of an endoscope.

[0125] In embodiments, the air is delivered to the lumen for about one minute to about 60 minutes, or about one minute to about 10 minutes, or about five minutes to about 10 minutes.

[0126] As shown in FIG. 7, tubing 42 of connector element 40 is coupled to powered dryer 30 by connecting first end 44 of element 40 to connector 34 of powered dryer 30. Second end 46 of tubing 42 is then connected to connector 106 on handle 102 of endoscope coupling device 50 (see FIG. 8). Nozzle 112 of coupling device 50 may then be coupled to one of the valves or ports on the endoscope, such as the air / water valve 128 shown in FIG. 9 A. Once nozzle 112 has been coupled to valve 128, strap 110 is wrapped around the scope body and protrusion 108 is inserted through one of the openings 109 in strap 110 to secure device 50 to the endoscope and firmly seat nozzle 112 to the opening of air / water valve 128. The user may select the opening 109 that provides the most secure fit.

[0127] Once the enzymatic detergent has been delivered into the lumen (such as a valve of an endoscopic) and allowed to reside therein for a sufficient amount of time, powered dryer 30 is fluidly coupled to one of the endoscope channels, the user may turn dryer 30 ON by pressing a button on user interface 36. In some embodiments, the pump will automatically start delivering air into the endoscope channel for a period of time, e.g., 45 seconds. In other embodiments, the user interface 36 may allow the user to select the period of time. In yet another embodiment, user interface 36 may further include an OFF button wherein the user may allow the pump to run into it is turned OFF.

[0128] In cases wherein the endoscope has an auxiliary water channel, such as certain gastroscopes and colonoscope, either drying device 200 and / or powered dryer 50 may be used to dry this channel. FIGS. 12 and 13 illustrate a representative valve or connector 150 for an auxiliary water channel 152 of an endoscope. Nozzle 112 of coupling device 50 is coupled to connector 150 and strap 112 is wrapped around the scope body and protrusion 108 is inserted through one of the openings 109 in strap 112 to secure device 50 to the endoscope and firmly seat nozzle 112 to the opening of connector 150.International Patent ApplicationAttorney Docket No. : GI 099-PCT

[0129] Once powered dryer 30 is fluidly coupled to one of the endoscope channels, the user may turn dryer 30 ON by pressing a button on user interface 36. In some embodiments, the pump will automatically start delivering air into the endoscope channel for a period of time, e.g., 45 seconds. In other embodiments, the user interface 36 may allow the user to select the period of time. In yet another embodiment, user interface 36 may further include an OFF button wherein the user may allow the pump to run into it is turned OFF.

[0130] Referring now to FIGS. 10A and 10B, the endoscope channels may also be dried by cleaning and / or drying device 200. In some cases, cleaning and / or drying device 200 may be used first to dry a channel, and then powered dryer 50 is used to redry the channel (as described above and shown in FIG. 11). In other cases, drying device 200 may be used by itself to dry a channel. In certain embodiments, powered dryer 50 is used to dry the smaller diameter channels in an endoscopic device, while drying device 200 is used to dry larger channels, such as a working channel for instruments and / or the air / suction channels.

[0131] In use, the user inserts filament end 24 of filament 22 through suction valve 126 and advances it through suction channel 132 towards the PV connector of the endoscope (e.g., suction connector 134) (see FIGS. 10A and 10B). Once filament end 24 exits connector 134, the user grasps filament end 24 and pulls filament as shown in FIG. 10B to advance drying element 300 through suction channel 132. Drying element 300 dries suction channel 132 as discussed in more detail below. It should be noted that the same method may be used for any of the other channels of the endoscope, including air channel 140 and instrument channel 144. For example, FIG. 14 illustrates drying element 300 as it exits the distal end of a working instrument channel 144 of endoscope 120. The advancing and retracting directions may be reversed.

[0132] In another aspect, a system for removing biomatter from a medical device comprises a source of enzymatic detergent and a cleaning device comprising an elongate member configured for advancement through a lumen within the medical device and at least one cleaning member coupled to a portion of the elongate member. The cleaning member comprises distal and proximal end portions and a central portion between the distal and proximal end portions, wherein the central portion is shaped to create a pressure gradient along the central portion from the distal end portion to the proximal end portion.International Patent ApplicationAttorney Docket No. : GI 099-PCT

[0133] The combination of the enzymatic detergent and the unique nature of the cleaning device is sufficient to remove pre-existing biomatter from the surfaces of the medical device, such as biomatter that has already formed into a biofilm (i.e., a multilayered organized matrix of bacterial, fungal algal or protozoan cells held on a surface by a mesh of polysaccharides). The detergent loosens the protective layer of polysaccharides and proteins of the biofilm and the cleaning device then removes both the protective layer and the underlying biomatter.

[0134] In embodiments, the enzymatic detergent comprises a material selected from the group consisting of proteases, hydrolases, amylases, lipases, cellulases, mannanases, pectinases and combinations thereof. The enzymatic detergent may comprise other components, such as protease inhibitors, surfactants and the like.

[0135] Referring now to FIG. 15, an exemplary cleaning and / or drying element 300 for device 200 will now be described. It should also be noted that cleaning and / or drying device 200 may also be used for cleaning, disinfecting and / or removing biomatter, biofilms, debris and / or pathogens from endoscopic device channels. A more complete description of a cleaning device for use herein can be found in U.S. Patent No. 11,357,394, the complete description of which is incorporated herein by reference for all purposes.

[0136] Drying and / or cleaning element 300 comprises proximal and distal end portions, that are preferably at least two channel wall contact elements 302, 304, which are typically cylindrical in shape in order to match the shape of the endoscope’s channels. Wall contact element 302, 304 create a consistent circumferential contact with the interior wall of an endoscope channel, such as a biopsy or suction channel. In certain embodiments, drying and / or cleaning element 300 may include secondary wall contact elements 303, 305 (or additional ones if desired) to enhance the engagement between the wall contact elements and the internal lumen walls and to ensure that the variable pressure region (discussed below) is effective.

[0137] Channel contact elements 302, 304 may comprise any suitable shape that substantially contacts and / or conforms to the walls of the internal lumen. In certain embodiments, channel contact elements 302, 304 preferably have a substantially circumferential, cylindrical, or conical shape with at least one portion of the element 302, 304 having a diameter approximately equal to or slightly larger than the diameter of the internalInternational Patent ApplicationAttorney Docket No. : GI 099-PCT lumen. In an exemplary embodiment, the largest diameter of channel contact elements 302, 204 is about 1 to about 1.5 times the diameter of the internal lumen, preferably about 1 to about 1.23 times this diameter. For example, if the diameter of the internal lumen is about 5 mm, the largest diameter portion of elements 302, 304 may be about 4.2 to 5.5 mm, preferably about 5 mm. This additional size allows elements 302, 304 to deform slightly as they pass through the lumen, ensuring that they will remain in contact with the lumen.

[0138] In certain embodiments, the contact elements are substantially conical such that they angle downwards in the proximal direction (or the direction of travel of the cleaning and / or drying device through the lumen of the endoscope), as shown in Fig. 4. This configuration allows contact elements 302, 304 to create a contact friction force along the internal walls of lumen so that they can slide along the walls of internal lumen of the endoscope without getting caught or otherwise stuck in the lumen, while still ensuring that at least a portion of contact elements 302, 304 remain in contact with the lumen. In an exemplary embodiment, contact elements 302, 304 are about 0.75 mm and taper to about 0.5 mm at their tips (or the point of contact with the internal wall of the lumen).

[0139] Drying and / or cleaning element 300 further includes a variable pressure region 306 between wall contact elements 302, 304. Variable pressure region 306 is designed to create variable pressure between the two circumferential contact elements 302, 304 and the wall of the channel being dried and / or cleaned. Thus, as the drying and / or cleaning member is advanced inside a channel and the scope and its channels are submerged in cleaning fluid, such as an enzymatic detergent, the variable pressure design between the two circumferential elements creates a venturi effect between the drying element and the walls of the endoscope channel when the cleaning and / or drying element is moved through the lumen. As a result, when the air flows across the variable pressure area, this impacts the fluid flow as it transfers from an area of high pressure across an area of low pressure and then back to another area of high pressure between the two cylindrical elements. This directs the air or fluid at the channel walls with an increased velocity and force, similar to the venturi effect created when putting one’s thumb partially over the end of a garden hose to increase the force of the water emitting from the hose. When used for cleaning or drying a lumen, these forces allow the cleaning and / or drying element to substantially remove all biomatter, biofilms, fluid and moisture from within the lumen (or contaminants when cleaning).International Patent ApplicationAttorney Docket No. : GI 099-PCT

[0140] Alternatively, variable pressure region 306 may be designed to create areas of low pressure on either end of region 306 with an area of high pressure there between. In this embodiment, when the air flows across the variable pressure area, this impacts the fluid or air flow as it transfers from an area of low pressure across an area of high pressure and then back to another area of low pressure between the two cylindrical elements. This may also be configured for other alternating areas of low and high pressure, or vice versa, or multiple areas of escalating or declining pressure, or other variations in pressure levels.

[0141] As shown in Fig. 15, variable pressure region 306 comprises a contraction section 308 coupled to the proximal contact element 302, a diffusion section 312 coupled to the distal contact element 304 and a throat section 310 coupling the diffusion and contraction sections 308, 310. The throat section 320 has a diameter less than the diameter of the contact elements 302, 204 and greater than a diameter of the diffusion and contraction sections 308, 310. This design enhances the performance of the air, water, cleaning fluid or enzymatic detergent by turning it from a static point of interaction with the walls of a scope channel, to a dynamic point of interaction where the lifting action of the air, water, cleaning fluid or enzymatic detergent is enhanced through drying member’s direction of the detergent at the walls of the scope channel with pressure.

[0142] Variable pressure region 306 may include an inverted, partial venturi shape, a parabolic shape, a variable slope shape or such other shape that creates variable pressure between the two cylinders and the wall of the channel being cleaned or dried, thereby increasing the force by which the air, water, cleaning fluid or enzymatic detergent is projected at the channel wall when the cleaning and / or drying member is advanced.

[0143] In an exemplary embodiment, throat section 310 is substantially cylindrical. The contraction section 308 preferably increases in diameter from the contact section 302 to the throat section 310 and the diffusion section 312 preferably decreases in diameter from the throat section 310 to contact section 304, thereby creating a venturi effect between the distal and proximal end portions 302, 304 of the drying and / or cleaning element 310.

[0144] In a preferred embodiment, variable pressure region 306 has an inverted, partial venturi shape with three distinct areas of various spacing from the wall of the scope channel, which creates accelerated aerodynamic action projecting air, water, cleaning fluid or enzymatic detergent at the channel wall to remove biomatter and biofilms more effectively.International Patent ApplicationAttorney Docket No. : GI 099-PCTThese areas include a contraction section 308, which is the start of the area where detergent is present on the other side of the first cylindrical element. The contraction section 308 is the start of the area in which air, water, cleaning fluid or enzymatic detergent accumulates and are subject to changing pressure as the space available for the fluid varies and becomes smaller as drying and / or cleaning element 300 is advanced and the air, water, cleaning fluid or enzymatic detergent is directed into the throat section 310 that further alters the pressure between the cleaning and / or drying element and the channel wall. The throat section 310, wherein the shape available for the detergent is reduced further in a manner that changes the pressure on the air, water, cleaning fluid or enzymatic detergent compared to the pressure on the air, water, cleaning fluid or enzymatic detergent in the contraction section, creates an acceleration of the detergent as the drying and / or cleaning element 300 is advanced; followed by a diffusion section 312 which supports the diffusion of the detergent at an accelerated speed as it exits the throat section. Collectively, these sections between the cylindrical elements create an aerodynamic force for air, water, cleaning fluid or enzymatic detergent sufficient to remove substantially all biomatter and biofilms from the lumens during a drying process and / or create a hydrodynamic force to remove biomatter and biofilms during a cleaning process.

[0145] The angle of the slope of the contraction section 308 (defined as the angle made between the vertical section of conical section 302 and the sloped portion of contraction section 308) may vary depending on the diameter of the channel being cleaned, the viscosity of the thickness of the air, water, cleaning fluid or enzymatic detergent and other factors and should be sufficient to support a variable pressure flow of air, water, cleaning fluid or enzymatic detergent between the cylinders when the cleaning and / or drying element is advanced. In certain embodiments, the contraction section defines an angle with the proximal end portion (i.e., contact section 302) that is about 4 degrees to about 85 degrees, preferably between about 15 degrees to about 30 degrees. Similarly, the diffusion section defines an angle with the distal end portion (i.e., contact section 304) that is about 4 degrees to about 85 degrees, preferably about 15 degrees to about 30 degrees. Of course, it will be recognized that various pressure regions 306 may have more than one slope, a curved shape, a variable shape, vortex, convex, concave, or such other shape which assists in varying the pressure between the two cylindrical elements 302, 304.International Patent ApplicationAttorney Docket No. : GI 099-PCT

[0146] Likewise, the angle between contraction and diffusion sections 308, 312 and throat section 310 may vary depending on the diameter of the channel being cleaned, the viscosity of the air, water, cleaning fluid or enzymatic detergent and other factors, and should be sufficient to support a variable pressure flow of air, water, cleaning fluid or enzymatic detergent between the cylinders when the drying and / or cleaning element is advanced. In certain embodiments, this angle is about 10 degrees to about 50 degrees, preferably about 15 degrees to about 30 degrees and more preferably about 20 degrees to about 25 degrees.

[0147] The length and diameter of each section of variable pressure region 306 are preferably selected to optimize the venturi effect and will vary based on the diameter of the internal lumen, the viscosity of the air, water, cleaning fluid or enzymatic detergent and other factors. For example, in a lumen having a diameter of about 4.2 mm, the length of throat section 310 may be about 2 mm to 10 mm, preferably about 3 mm to 5 mm, and more preferably about 4 mm. The outer diameter of throat section 310 will also depend on the diameter of the inner lumen as well as the diameter of contraction and diffusion sections 308, 312. In certain embodiments, throat section 310 is less than the diameter of the internal lumen, but greater than 50% of the diameter of the lumen, preferably greater than about 60% of the diameter of the lumen, and more preferably equal to or greater than about 70% of the diameter of the lumen (e.g., about 3 mm in a lumen having an inner diameter of about 4.2 mm).

[0148] The venturi effect created by variable pressure region 306 impacts the air, water, cleaning fluid or enzymatic detergent flow as it transfers from an area of high pressure across an area of low pressure between the two cylindrical elements, and then back to another area of high pressure, such that the air, water, cleaning fluid or enzymatic detergent is directed at the channel walls with an increased force. Computational modeling using fluid and pressure dynamics shows that, in embodiments, the application of inverted venturi principles to create variable pressure between two cylindrical elements directs the detergent at all of the channel wall with air pressures of variable and increasing force to create a new, highly effective drying and / or cleaning capability that can remove moisture and biomatter from the channel.

[0149] When the drying and / or cleaning element is advanced through a lumen having a fluid or air therein, the variable pressure region of the drying element is configured to generate fluid pressure against the internal wall of the lumen. In certain embodiments, the variable pressure region is configured to generate a peak pressure of at least about 75 Pa in at least one area between the distal and proximal end portions of the dry9ing element. This peak pressureInternational Patent ApplicationAttorney Docket No. : GI 099-PCT is preferably at least 100 Pa and more preferably at least 125 Pa. In an exemplary embodiment, the peak pressure may be approximately 150 Pa. This direct pressure against the lumen wall is sufficient to remove substantially all moisture from the internal surface of the lumen.

[0150] The variable pressure region of the drying and / or cleaning element is configured to generate an average or mean pressure across the distance between the proximal and distal end portions of the cleaning and / or drying element of at least about 10 Pa, preferably about 20 Pa and more preferably about 30 Pa. In an exemplary embodiment, the mean pressure is about 36 Pa.

[0151] The variable pressure region of the cleaning and / or drying element is also configured to generate a peak shear stress of at least about 4 Pa in at least one area between the distal and proximal end portions of the cleaning and / or drying element, preferably at least about 5 Pa and more preferably at least about 8 Pa. The average or mean shear stress across the distance between the proximal and distal end portions of the cleaning and / or drying element is at least about 1 Pa, preferably about 2 Pa and more preferably greater than 2.5 Pa. In an exemplary embodiment the mean shear stress is about 2.8 Pa.

[0152] The variable pressure region of the drying element is configured to generate a substantially high pressure across a relatively large coverage area between the proximal and distal ends of the drying and / or cleaning element. This increases the amount of time that the inner surface of the lumen is subjected to this substantially high pressure, thereby increasing the amount of biomatter or biofilms that can be removed with the device. For definitional purposes, Applicant has defined the Peak Pressure Coverage Area (PPAC™) as the distance between the proximal and distal ends of the drying and / or cleaning element in which the variable pressure region generates a pressure above 50 Pa. In certain embodiments, the drying and / or cleaning element is configured to generate a PPAC in at least about 10% of this distance, preferably at least about 25% of this distance and more preferably at least about 40% of this distance.

[0153] The variable pressure region of the drying and / or cleaning element is also configured to generate at least some positive pressure against the internal lumen across a relatively large coverage area between the proximal and distal ends of the drying element. This increases the amount of time that the inner surface of the lumen is subjected to at least some cleaning or drying pressure, thereby increasing the amount of biomatter that can be removedInternational Patent ApplicationAttorney Docket No. : GI 099-PCT with the device. For definitional purposes, Applicant has defined the Positive Pressure Area (+PAC™) as the distance between the proximal and distal ends of the drying element in which the variable pressure region generates a positive pressure (i.e., above zero). In certain embodiments, the drying and / or cleaning element is configured to generate a +PAC in at least about 25% of this distance, preferably at least about 50% of this distance and more preferably at least about 75% of this distance. In an exemplary embodiment, the +PAC may be as high as 81%.

[0154] In embodiments, a ratio of contraction may be determined between the contraction section 308 and the throat section 310, though the ratio may change and vary depending on the diameter of the scope channel being cleaned, the durometer of the material used for drying and / or cleaning element 300, the projected speed and force applied to withdraw the navigation element 301 after it is attached to drying and / or cleaning element 300 or otherwise advanced through the channel, the viscosity of the air for drying or the water, cleaning fluid or enzymatic detergent for cleaning, the desired fluid friction force of the fluid projected by drying and / or cleaning element 300 and the direction of the flow exiting the throat section, including whether a narrow or broader flow is desired with the design.

[0155] The overall length of variable pressure region 306 will depend on a variety of factors, including but not limited to, the diameter of the lumen, the viscosity of air within the lumen, the specific shape, and angles of contraction, 308, throat 310 and diffusion 312 sections and the like. In an exemplary embodiment, the length of variable pressure region is about 5 mm to about 20 mm, preferably about 10 mm.

[0156] Additionally, the angle of the surface of the diffusion section 312 may be a single plane or multiple planes. In embodiments the angle of the surface of the diffusion section 312 increases the space between the wall of the endoscope channel and element 300, in embodiments, in the diffusion section. This variation allows the air to accelerate at a higher pressure and velocity out of the throat section to create elevated and increasing fluid or air pressure force against the walls of the endoscope channel as element 300 is advanced through the endoscope channel.International Patent ApplicationAttorney Docket No. : GI 099-PCT

[0157] In embodiments, drying and / or cleaning element 300 may not have a three section arrangement and instead could have other shapes and forms intended to modify the pressures between the two cylinders and create elevated pressure sufficient to remove moisture from the walls of the scope’s channels.

[0158] In certain embodiments, the distance between the two cylindrical elements is any distance necessary to a variable pressure shape between the two cylindrical elements. In embodiments, the distance may be between 5 and 10 mm if the diameter of the scope channel being cleaned or dried is between 4 mm and 4.5 mm. In other embodiments, the distance may be a ratio relative to the diameter of the scope channel, such as less than 4: 1, less than 2: 1 or less than 1.5:1 or other ratio (distance: diameter of scope channel).

[0159] The diameter of the cylindrical elements may be designed to avoid deflection of proximal and distal end portions 302, 304. Deflection of these cylindrical elements can create a gap due to buckling that results in less than idea cleaning or drying results. This is one of the issues with pull thru cleaners, which are as large as 5.2 mm in diameter, but are applied in channels ranging in size from 2.8 mm to 5.0 mm in diameter and which must buckle to advance through the channel. In embodiments, the diameter of the cylindrical elements is between 1.0 and 1.23 times the diameter of the channel being cleaned or dried to keep the cleaning / drying device 200 centered in the channel being cleaned, with minimal to limited deflection of the ends of the cylindrical elements. Additionally, a deflection equation may be used to obtain the optimal cylindrical elements.

[0160] If the cylindrical elements are too high in diameter relative to the channel size, this can result in ineffective cleaning or drying due to gaps in the cylinders, deflection of the cleaning / drying device, too much resistance to pull the cleaning / drying device 200 consistently through the channel, among other issues. The materials selected can also impact this result. In embodiments, the material has a durometer between 35 and 70 shore A, depending on the cylinder size and design, though different durometers and multiple durometers in the same device may be used.

[0161] In embodiments, the dimensions of cleaning / drying device 200 may allow for the advancement of the drying element from the distal end without being caught on the elevator of duodenoscopes or endoscopic ultrasound scopes, which is an issue with current bristle brushes and pull through cleaners, though the dimensions of the cleaning / drying device 200International Patent ApplicationAttorney Docket No. : GI 099-PCT may also allow for passing through the scope channel in the opposite direction, from proximal to distal.

[0162] FIGS. 17-21 illustrate the various mechanisms of action of drying and / or cleaning element 300. As shown in FIG. 17, the variable pressure region 306 of drying and / or cleaning element 300 causes the air or fluid 500 to exert pressure against the internal walls 502 of a lumen 504 within an endoscopic device to remove water or moisture (as discussed above) and / or biomatter, debris, chemicals, and pathogens. In addition, variable pressure region 306 generates a vacuum pressure that creates suction 506 for further removal of the moisture or biomatter, debris, chemicals and pathogens (see FIG. 18). Variable pressure region 306 also creates a sweeping action 510 that removes moisture or biomatter, debris, chemicals and pathogens (see FIG. 19). Finally, proximal, and distal end portions 302, 304 of each drying and / or cleaning element 300 contact the internal walls 502 of lumen 504 to “scrub” against these walls, ensuring that any remaining moisture or biomatter, debris, chemicals and pathogens is removed from the lumen 504 (see FIG. 20). A more complete description of a cleaning and / or drying element 200 may be found in U.S. Patent No. 11,357,394 and U.S. Application Serial No. 18 / 226,492, the complete disclosures of which are incorporated herein by reference for all purposes.

[0163] In embodiments, the cleaning and / or drying device 200 may have one or more absorbent sponges placed in front of or at the end of drying element 300 or in between one or more of the cylindrical elements to absorb biomatter and debris and fluid. The absorbent sponges may be of a single cell configuration or have multiple sponges with different cell configurations to provide scrubbing, absorption, lifting, or a combination of these attributes. The absorbent sponges may be of any material, including polyurethane, polyvinyl alcohol, or other absorbent material. In embodiments, the sponges are soft and atraumatic when immersed in fluid, and expand to a size that is at least the size of the channel being dried, and in a preferred embodiment is larger than the channel being dried. The sponges may be any shape that conforms and aids in drying the scope’s channel, including by way of example, not limitation, cylindrical in shape, spiral in shape, conical, triangular, square or any combination thereof. In an exemplary embodiment, the sponge(s) will have a pore size of between about 200 to 1500 PPC, preferably between about 200 PPC and about 600 PPC.International Patent ApplicationAttorney Docket No. : GI 099-PCT

[0164] In embodiments, drying and / or cleaning device 200 may include a brush of various designs which contacts a portion of the channel wall in addition to the other aspects of drying element 300. The brush may be of a length that is in the ration of 1.0 to 1.4 times the diameter of the channel to be dried. In embodiments, the brush is preferably made of an atraumatic polymer, such as nylon, acrylic or polyurethane, with a thickness and durometer designed to limit trauma and injury to the channel wall, while maintaining sufficient rigidity to remove contamination or moisture from the walls of the channel. The diameter of the brush elements contacting the channel wall may be any diameter, but in embodiments may be between .5 and 2 mm. The brush elements may be perpendicular to the navigation element and in embodiments, may be part of a separate, shorter navigation element designed to reach only a few a limited distance into the biopsy channel. This shorter version may be any length appropriate for drying the initial entry points into the biopsy channel, but in a preferred embodiment is between 4.5 and 15 cm long. This brushing element, whether part of the drying and / or cleaning element or in a separate shorter version, may also utilize nylon or other polymer wire bristles or other bristles if arranged in a pattern that is effective in drying and / or cleaning and minimizes trauma to the scope channel. A grip element of the brush may have a shape at one end or in the center of the element that is larger to facilitate introduction into the biopsy channel.

[0165] In certain embodiments, drying device 300 may contain multiple cylindrical elements with variable pressure elements in between the cylindrical elements, such as, for example, a series of five sets of cylindrical elements with a variable pressure element between each of the cylinders. The variable pressure element may be the same or may vary to create alternating pressure profiles. The multiple cylindrical elements with variable pressure elements between the cylindrical elements may be greater or less than five sets, as appropriate for the given application.

[0166] Referring now to FIG. 16B, one embodiment of a cleaning and / or drying device 400 with multiple cleaning and / or drying elements 300 will now be described. As shown, each cleaning and / or drying element 300 includes proximal and distal end portions 302, 304 and a variable pressure region 306 therebetween, as described above. Proximal and distal end portions 302, 304 are preferably cylindrical elements having an outer diameter substantially the same as the inner diameter of the lumen to be dried (as discussed in detail below). In this embodiment, the cleaning and / or drying elements are coupled to each other atInternational Patent ApplicationAttorney Docket No. : GI 099-PCT the proximal and distal end portions. In an exemplary embodiment, the proximal end portion of one cleaning and / or drying element is integral with the distal end portion of the next cleaning and / or drying element, although it will be recognized that other configurations are possible. For example, cleaning and / or drying device 400 may have more than one cylindrical element placed near another cylindrical element with a spacing that does not create variable pressure, followed by or, alternatively, before, a cylindrical element with a spacing between the next cylindrical element that creates variable pressure between cleaning and / or drying element 300 and the wall of the channel being cleaned or dried. In embodiments, a series of cylindrical elements may be organized in various spacing to create variable pressure between the cylindrical elements and certain spacing to create constant pressure between the cylindrical elements.

[0167] Cylindrical elements 302, 304 may be made of any shape and size that makes contact and conforms at least in part to the walls of the channel being cleaned or dried, including in embodiments, cylindrical elements with a taper, a reverse taper, cylindrical elements that deflect and contact each other or which deflect and do not contact another cylindrical element, or which contact or do not contact a variable pressure shape between the cylindrical elements. The cylindrical elements do not have to be cylindrical, but need to be able to assist with creating a variable pressure result with the rest of the elements of cleaning and / or drying device 400, which means they must have wall contact that is meaningful enough to support creating a variable pressure area to accelerate air flow and thereby direct the cleaning air at the channel wall with pressure.

[0168] In embodiments, each cleaning and / or drying element 300 is between 2.5 cm and 7.5 cm long and cleaning and / or drying device 400 contains multiple variable pressure areas separated by multiple cylindrical elements. In a preferred embodiment, cleaning and / or drying device 400 contains five variable pressure areas separated by six cylindrical elements. In certain embodiments, cleaning and / or drying device 400 may include two additional cylindrical elements 402, 404 at a distal end of the device 400.

[0169] Referring now to FIG. 16A, another embodiment of a drying and / or cleaning device with multiple cleaning or drying elements will now be described. As in the previous embodiment, each drying and / or cleaning element 300 includes proximal and distal end portions and a variable pressure region therebetween, as described above. The proximal and distal end portions are preferably cylindrical elements having an outer diameter substantiallyInternational Patent ApplicationAttorney Docket No. : GI 099-PCT the same as the inner diameter of the lumen to be dried (as discussed in detail below). In this embodiment, the drying elements are coupled to each other at the proximal and distal end portions. In an exemplary embodiment, the proximal end portion of one drying element is integral with the distal end portion of the next drying element, although it will be recognized that other configurations are possible.

[0170] In this embodiment, the drying and / or cleaning device further includes one or more substantially cylindrical drying members 422 located at or near the proximal end of the drying device. Drying and / or cleaning members 422 are substantially cylindrical and, therefore, do not include the variable pressure region discussed above.

[0171] The drying and / or cleaning device may further include a centering element 424 on either or both proximal and distal end portions of the drying and / or cleaning device. Centering element(s) 424 serve to center filament 22 (see FIG. 2) and the drying and / or cleaning device as the device is pulled or pushed through lumens, including around turns and navigation through corners and other complex areas, including junctions of multiple lumens and internal channels in the scope or other instrument being dried, including variable diameter areas. Centering element(s) 424, in embodiments, may be smaller than the diameter of the lumen through which the device is being advanced, but have a significant enough size to prevent misalignment and deflection of the navigation element 301 to one side or another of the lumen as it navigates, including as the drying device as it is pulled or pushed around curves, corners and junctions of various lumens (including Y junctions).

[0172] Centering element(s) 424 may be any shape that keeps the device generally centered and prevents this deflection, with a preferred embodiment being a cylindrical shape with a tapered distal end. When this sort of misalignment occurs, which is an issue with existing brushes and pull thru cleaners, the brushes and other elements are pulled to one side of the lumen as they are pulled around curves, corners and junctions of lumens, with the result being contact with the lumen wall and the drying element (whether a brush, pull thru or other device) is minimized, adversely changed, or lost, resulting in an adverse impact on the effectiveness of the drying approach. By placing a centering element at the front, back, or both, of the device, this issue is corrected, resulting in more consistent, effective drying, especially around curves, comers, channel junctions and other complex areas inside an endoscope or other endoscopic instrument or device.International Patent ApplicationAttorney Docket No. : GI 099-PCT

[0173] In some embodiments, drying and / or cleaning element 424 may comprise a series of shaped elements proj ecting from the elongate member or the navigation member. This series of shaped elements may, for example, comprise struts, spikes, or other projections extending radially outward from the elongate member and sized to substantially center the elongate member and / or the drying elements within the internal channel of the endoscopic device.

[0174] In a preferred embodiment, centering element(s) 424 are between 50 percent and 90 percent of the diameter of the lumen being dried, with a further preferred embodiment having a diameter or height between 70 percent and 85 percent of the diameter of the lumen being dried. Centering element(s) 424 can be any shape that preserves the centering of the drying element as it is navigated through a channel. In embodiments, this includes cylindrical, conical, spherical and a centering element may be placed at the distal area of the device, at the distal and proximal end, between drying members, or the proximal end, as appropriate to aid in centering the drying element, especially as it navigates around curves, across Y-junctions and other aspects of a lumen.

[0175] In some embodiments, one or more of the above described components may be automated, i.e., configured for delivery by a motor, pump or other machine that is driven by a power source. The automated system advances the cleaning and / or drying member through the channel of the endoscopic instrument, rather than through the manual process described above. In various embodiments, the power source comprises a motor configured for coupling to the cleaning device and advancing the elongate member and the cleaning member through the channel of the endoscopic device. The motor may comprise any suitable motor, such as a stepper motor, DC motor, AC motor, servomotor, induction motor, magnetic motor, gear motor, linear motor, shunt motor, compound, or single phase motor, vacuum pump or other non-human actuator to advance or retract the cleaning device. The motor may be configured to pull or push the elongate member through the channel. In one embodiment, the motor comprising a moving internal waterjet that advanced the cleaning member(s) through the channels while delivering fluid therethrough. The waterjet and / or the cleaning member may comprise a centering element (as described below).

[0176] In an exemplary embodiment, the motor is configured to advance the cleaning and / or drying member through the lumen at a specific rate of speed or a variable rate of speed. The velocity of the cleaning and / or drying member may be selected by the user on a userInternational Patent ApplicationAttorney Docket No. : GI 099-PCT interface coupled to the power source. This ensures that the cleaning and / or drying member moves at a velocity suitable for effectively removing biomatter, debris and bacteria from the channels in an endoscope.

[0177] In various embodiments, the cleaning and / or drying system further comprises a fluid delivery device configured to deliver a fluid through the lumen of the endoscopic device. The fluid may comprise any suitable cleaning fluid, such as an enzymatic cleaner, detergent or a ph-neutral non-enzymatic cleaner. In an exemplary embodiment, the cleaning and / or disinfectant formulations comprise one or more of glutaraldehyde, thophthalaldehyde, peracetic acid, chlorine, hydrogen peroxide, phenol / phenate, alcohol, microbicidal agents or the like. Alternatively, or in addition, the fluid may comprise any suitable drying fluid, such as air, ethyl or isopropyl alcohol or combinations thereof.

[0178] In various embodiments, the fluid delivery device comprises a pump for delivering the fluid under pressure through the channel of the endoscopic device. The device may further include a tube coupled to the pump and a connector or adaptor configured for coupling the tube to the channel of the endoscopic device. The adaptor may comprise any suitable adaptor, such as one configured for coupling a tube to a valve of an endoscope, such as an air valve, water valve, biopsy valve, suction valve, or an opening to a working channel of the endoscope.

[0179] Referring now to FIGS. 21-26, another embodiment of an automated cleaning and / or drying system 600 for cleaning, disinfecting and / or drying one or more channels in an endoscopic device, such as an endoscope, will now be described. System 600 may include the components described herein in combination with any of the above embodiments, such as the cleaning and / or drying devices 200, the cleaning and / or drying system 10, the powered dryer 30, the endoscope coupling element 50 and / or the connector 40.

[0180] System 600 comprises a housing 602, which may have any suitable shape. In one embodiment, housing 602 comprises a generally rectangular upright shape and includes a basin 604 at a top portion of the housing 602 for receiving an endoscopic device. Housing 602 may further include a retractable lid 606 for protecting the interior of basin 604. Basin 604 may include one or more channel ports 608 for coupling to openings and / or valves of endoscopic devices (described below) and an overflow drainInternational Patent ApplicationAttorney Docket No. : GI 099-PCT612 for allowing excess fluid to exit basin 604. Housing 600 may comprise a control panel or user interface 610 for allowing a user to operate certain functions of system 600. In some embodiments, housing 602 comprises a side compartment 620 for providing user access to cleaning fluids 622, drying fluids 624 and / or a water filter 626. Housing 602 may comprise an automatic endoscope reprocessor (AER), such as, for example, the AEROFLEX™ AER sold by Advanced Sterilization Products, Inc., the OER-Pro sold by Olympus America, the System IE (or System 1 endo) Liquid Chemical Sterilant Processing System, sold by Steris Corporation or similar such systems.

[0181] Automated system 600 may be used to clean, disinfect and / or dry a variety of different reusable endoscopic devices, including, but not limited to, respiratory tract endoscopes, urinary tract endoscopes, gastro-intestinal endoscopes, duodenoscopes with a sealed elevator channel, duodenoscopes with an open elevator channel and the like.

[0182] Referring now to FIGS. 24 and 25, an endoscope 630 may be placed into basin 604 and one or more of the valves and / or openings of endoscope 630 may be coupled to a connection port 608 within basin 604. For example, FIG. 24 schematically illustrates some of the valves of an endoscope, such as an air valve 632, a water valve 634, a biopsy valve 636, a suction valve 638 or an instrument working channel valve 640 (see also FIG. 25). Cleaning, disinfection, sterilization and / or drying fluids are then delivered from housing 602 through connection ports 608 and into one or more of the channels within the endoscope. Water is also delivered to various points to flush out debris or a previously used chemical. The fluid may comprise any suitable cleaning disinfection or sterilization fluid, such as detergents and cleaning formulations comprising one or more of glutaraldehyde, thophthalaldehyde, peracetic acid, chlorine, hydrogen peroxide, phenol / phenate, alcohol, microbicidal agents or the like. The fluid may comprise any suitable drying fluid, such as air, ethyl or isopropyl alcohol or combinations thereof.

[0183] Once the connection ports 608 are attached to the various valves or openings of the endoscope 630, the lid 606 may be closed and the user may commence an endoscopic device reprocessing cycle with user interface 610. This cycle may include, for example, a disinfectant cycle, thermal self-disinfect cycle, chemical self-disinfectant cycle, a cleaning cycle and / or a drying cycle and water flushing. In embodiments, it mayInternational Patent ApplicationAttorney Docket No. : GI 099-PCT also include a sterilization cycle. The system automatically delivers fluid under pressure through the channels of the endoscope to clean, disinfect, sterilize and dry these channels.

[0184] In one embodiment, cleaning and / or drying device 200 is incorporated into system 600 such that elongate filament 24 may be advanced through one or more of the channels of endoscope 630 while the cleaning and / or drying fluid is delivered therethrough. In this embodiment, cleaning and / or drying device 200 may be manually or automatically advanced through the channels while the fluids are delivered therethrough under pressure. In an exemplary embodiment, system 600 further comprise a power source and a motor (as described above) for automatically advancing filament 24 through the endoscope’s channels. The power source may be the same power source within housing 602 that drives the fluid delivery pump(s), or it may be a separate power source. The motor may be housed within housing 602 or it may be housed in another container. Cleaning and / or drying device 200 may also be advanced or retracted with a robotic arm, wire, wire and pully system or other devices. The cleaning and / or drying device may pass through a flushing or rinsing area after each channel pass to remove any debris before the next pass. In embodiments, the cleaning and / or drying device may pass through a drying or cleaning area (by air or contact or other means) to remove moisture before the next pass.

[0185] Cleaning and / or drying device 200 may be delivered through the same tube(s) that couple connection ports 608 to the internal channels of the scope. Alternatively, system 600 may comprise a two-way connector (not shown) having a first opening that allows for the valves to be coupled to both connection port 608 and a second opening that allows for the passage of device 200 into the valve or opening of the channels. In this embodiment the two-way connector may include one-way valves on each of the openings to prevent fluid from passing back through the connector (i.e., to ensure a substantially leak-proof system).

[0186] System 600 may further include a controller, computer device, processor or the like that controls the combined cleaning or drying operation. For example, the controller may be configured to control the velocity, flow rate, mass flow rate, or other parameters of the fluid. The controller may be configured to control the velocity of cleaning or drying device 200 as it passes through the channels. The controller may beInternational Patent ApplicationAttorney Docket No. : GI 099-PCT configured to control both the velocity of the cleaning or drying device and the parameters of the fluid such that the two modalities work together to increase the overall efficiency of the cleaning and / or drying operation.

[0187] In another embodiment, system 600 may further include powered dryer 30 and / or endoscopic coupling device 50 to provide additional benefits to the drying operation of system 600. Powered dryer 30, for example, may be incorporated within housing 602, or it may be provided separately from housing 602 or as components in combination. The controller within housing 602 may be configured to operate dryer 30 in combination with the pump that delivers drying fluid, such as air or alcohol, into the channels of the endoscope. For example, controller may be configured to control the volumetric flow rate and / or the frequency that the drying fluid is delivered from dryer 30 into the endoscope channels. In addition, system 600 may further include a timing module that monitors the time period the pump is activated to delivery air. The pump may also be set (automatically or manually) with a preset drying cycle such that it delivers air for a period of time, such as about 10 seconds to about 5 minutes, or about 20 seconds to about 3 minutes, or about 30 seconds to about 2 minutes or about 45 seconds.

[0188] The cleaning and / or drying device may be provided sterile. Sterilization may be accomplished by any method known in the art, including ETO, gamma, hydrogen peroxide and the like. Any sterilized device may be provided in a sterile pack. The connector 10 and tubing set 40 may also be provided sterile in a sterile packaging. A cleaning and / or drying device may be provided in a separate case, cartridge or other delivery element that is inserted inside an AER. An advancement or retraction element connects the cleaning and / or drying device manually or automatically to then move the cleaning and / or drying device through the internal lumens of the endoscopic device to be cleaned.

[0189] Referring now to FIGS. 26-29, the systems, methods and devices described herein provide a number of distinct advantages over conventional cleaning, drying and / or reprocessing systems. For example, in a conventional reprocessing sequence, the system performs the following steps: (1) pre-cleaning to flush the internal channels of the device, such as an endoscope; (2) submerging the device and passing a channel cleaner through the internal channels of the device; (3) flushing these channels with detergent, water and air; (4) inserting the device into an AER and attaching tubing to the internal channels; and (5) commencing theInternational Patent ApplicationAttorney Docket No. : GI 099-PCT automated detergent infusing, water flushing, disinfectant infusing and water flushing steps with the AER, which are repeated multiple times.

[0190] In one method schematically illustrated in FIG. 26 as the “Revised Approach #1”, the cleaning and / or drying devices described herein may be used to reduce or eliminate the first step in the conventional reprocessing sequence (i.e., pre-cleaning the scope channels). Thus, the cleaning device is passed through the internal channels of the endoscope prior to placing the endoscope into an AER. From clinical experience demonstrated in actual endoscope cleaning and confirmed with a rapid protein assay, one pass of the cleaning device described herein and one detergent and water flush resulted in a perfect score (i.e., the protein assay did not reveal any pathogens, contaminants or other debris in the channels). After completing this step, the device is subjected to steps 2-5 of the conventional reprocessing sequence, as described above. Eliminating the requirement for step 1 (pre-clean and detergent flushing), reduced the amount of detergent and water flushing by 66%, which would save between 5 to 10 gallons of water for each endoscope that is reprocessed.

[0191] In another method schematically illustrated in FIG. 27 as the Revised Approach #2, the cleaning devices described herein are incorporated into an AER as described above. In this method, the first three steps of the conventional reprocessing sequence are eliminated. Instead, the device is immediately placed into the AER and the internal channels are filled with water. The cleaning and / or drying devices described herein are advanced through the internal channels. This method substantially reduces the water required to flush the scope channels, thereby reducing the duration of the process, which reduces water and detergent consumption and wear and tear on the components of the AER.

[0192] In another method schematically illustrated in FIG. 28 as the Revised Approach #3, the first step of the conventional reprocessing sequence (i.e., pre-cleaning) is performed, but the second and third steps are eliminated. Thus, after precleaning, the device is immediately placed into the AER and the internal channels are filled with water. The cleaning and / or drying devices described herein are advanced through the internal channels. This substantially reduces the water required to flush the scope channels, thereby reducing the duration of the process, which reduces water and detergent consumption and wear and tear on the components of the AER.International Patent ApplicationAttorney Docket No. : GI 099-PCT

[0193] In yet another method schematically illustrated in FIG. 29 as the Revised Approach #4, the cleaning and / or drying devices described herein can be used prior to insertion of the endoscope into the AER (i.e., prior to the conventional reprocessing sequence). This method requires a cleaning and / or drying device and a 5 gallon or smaller container of water and detergent. The scope is submerged in the container and the cleaning device is passed through the internal channels as described above. After this step, the endoscope is then placed into the AER and conventional reprocessing sequence is performed. This method uses at least 50% less water and detergent than the conventional reprocessing sequence alone, and provides substantially greater effectiveness than the conventional reprocessing sequence alone.

[0194] In yet another aspect, a system or kit is provided for cleaning and / or drying the exterior surfaces of medical devices. The kit is particularly useful for cleaning and drying the exterior portions of endoscopic devices, such as endoscopes. For example, the kit may be used for cleaning and drying surface features on endoscopes, such as deflection control and locking knobs or wheels, angulation control and locking knobs or wheels, remote switches, exterior caps and / or surfaces of suction valves, air / water valves, biopsy valves and / or auxiliary water inlets, zoom levers, the grip section, the “boot”, instrument channel ports, the umbilical cord, insertion tubes and the like.

[0195] The kit or system comprises a cleaning wipe, such as a sterile lint-free cloth or wipe that may comprise any suitable material, such as polyester, microfiber and / or nonwoven materials such as polyester cellulose blends. The cleaning wipe may be sterilized in any suitable manner, such as gamma irradiation or the like. The cleaning wipe may include other components, such as isopropyl alcohol, water, deionized water, bleach, peroxide, sodium hypocholorite, sodium chloride, sodium carbonate and / or sodium hydroxide. The cleaning wipe may be double or triple bagged to maintain sterility before use.

[0196] The system of kit may further include a cleaning and drying device 200 and / or a powered dryer 30, as shown in FIG. 1.

[0197] In use, the cleaning wipe may be used first to clean virtually all surfaces of the endoscopic device by removing the cleaning wipe from its container and wiping down all such surfaces. The surfaces may then be dried with drying device 200 by, for example, connecting tubing 42 of connector element 40 to powered dryer 30 by connecting first end 44 of element 40 to connector 34 of powered dryer 30. Second end 46 of tubing 42 may then be connectedInternational Patent ApplicationAttorney Docket No. : GI 099-PCT to a suitable nozzle (not shown) for drying the exterior surfaces of the device. Alternatively, the distal end of tubing 42 may be used as a nozzle.

[0198] Once powered dryer 30 is fluidly coupled to connector 34, the user may turn dryer 30 ON by pressing a button on user interface 36. In some embodiments, the pump will automatically start delivering air into the endoscope channel for a period of time, e.g., 45 seconds. In other embodiments, the user interface 36 may allow the user to select the period of time. In yet another embodiment, user interface 36 may further include an OFF button wherein the user may allow the pump to run into it is turned OFF.

[0199] In certain aspects, the kit may be used for cleaning and drying multiple components of an endoscopic device. In these embodiments, the kit may further include endoscope coupling device 50 for fluidly coupling dryer 30 to an internal lumen of the device, as described above. In use, the kit may be used to clean and dry the exterior surfaces of the device, as described above, and used to clean and / or dry the internal lumens and channels of the device.

[0200] Hereby, all issued patents, published patent applications, and non-patent publications that are mentioned in this specification are herein incorporated by reference in their entirety for all purposes, to the same extent as if each individual issued patent, published patent application, or non-patent publication were specifically and individually indicated to be incorporated by reference.

[0201] While several embodiments of the description have been shown in the drawings, it is not intended that the description be limited thereto, as it is intended that the description be as broad in scope as the art will allow and that the specification be read likewise. Persons skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Various alternatives and modifications can be devised by those skilled in the art without departing from the description. Accordingly, the present description is intended to embrace all such alternatives, modifications, and variances. As well, one skilled in the art will appreciate further features and advantages of the present description based on the above-described embodiments. Accordingly, the present descriptionInternational Patent ApplicationAttorney Docket No. : GI 099-PCT is not to be limited by what has been particularly shown and described, except as indicated by the appended claims.

[0202] For example, in one aspect, a first embodiment is a system for removing biomatter from a medical device. The system comprises a source of enzymatic detergent; and a cleaning device comprising an elongate member configured for advancement through a lumen within the medical device and at least one cleaning member coupled to a portion of the elongate member, wherein the cleaning member comprises distal and proximal end portions and a central portion between the distal and proximal end portions, wherein the central portion is shaped to create a pressure gradient along the central portion from the distal end portion to the proximal end portion.

[0203] A second embodiment is the first embodiment, wherein the cleaning device is configured to remove pre-existing biomatter from the lumen of the medical device.

[0204] A third embodiment is any combination of the above embodiments, wherein the cleaning device is configured to remove a biofilm from the lumen of the medical device.

[0205] A 4th embodiment is any combination of the above embodiments, wherein the enzymatic detergent comprises a component selected from the group consisting of proteases, amylases, lipases, cellulases, mannanases and combinations thereof.

[0206] A 5th embodiment is any combination of the above embodiments, further comprising a fluid delivery device for delivering the enzymatic detergent into the lumen of the medical device.

[0207] A 6th embodiment is any combination of the above embodiments, further comprising a pump for delivering the enzymatic detergent under pressure.

[0208] A 7th embodiment is any combination of the above embodiments, wherein the device comprises a housing comprising a basin for receiving the enzymatic detergent and the medical device.

[0209] An 8th embodiment is any combination of the above embodiments, wherein the basis is configured such that the medical device is substantially immersed within the detergent.International Patent ApplicationAttorney Docket No. : GI 099-PCT

[0210] A 9th embodiment is any combination of the above embodiments, further comprising a connector for coupling a tube to a lumen of the endoscopic device and a power source for delivering the enzymatic detergent through the tube and the lumen of the medical device.

[0211] A 10th embodiment is any combination of the above embodiments, wherein the power source is coupled to the cleaning device and configured to advance the cleaning member through the lumen of the endoscopic instrument.

[0212] An 11th embodiment is any combination of the above embodiments, further comprising a motor coupled to the power source and the cleaning device.

[0213] A 12th embodiment is any combination of the above embodiments, wherein the motor is configured to advance the elongate member through the lumen at a specific rate.

[0214] A 13th embodiment is any combination of the above embodiments, wherein the central portion of the drying member comprises a contraction section coupled to the proximal end portion, a diffusion section coupled to the distal end portion and a throat section coupling the diffusion and contraction sections, wherein the throat section has a diameter less than the diameter of the proximal and distal end portions and greater than a diameter of the diffusion and contraction sections.

[0215] A 14th embodiment is any combination of the above embodiments, wherein the contraction section increases in diameter from the proximal end portion to the throat section and the diffusion section decreases in diameter from the throat section to the distal end portion and wherein the throat section is substantially cylindrical.

[0216] A 15th embodiment is any combination of the above embodiments, wherein the cleaning member has one or more centering elements positioned on either end of the cleaning member for centering the cleaning member as the cleaning member is advanced through a lumen.

[0217] A 16th embodiment is any combination of the above embodiments, wherein the lumen comprises an internal channel of an endoscope.

[0218] A 17th embodiment is any combination of the above embodiments, and further comprising a method for removing biomatter from a medical device, the method comprising: delivering an enzymatic detergent into a lumen of the medical device; and advancing anInternational Patent ApplicationAttorney Docket No. : GI 099-PCT elongate member of a cleaning device through the lumen within the medical device such that at least one cleaning member passes through the lumen in contact with an internal surface of the lumen.

[0219] An 18th embodiment is any combination of the above embodiments, wherein the cleaning member and the enzymatic detergent are sufficient to remove pre-existing biomatter from the internal surface of the lumen.

[0220] A 19th embodiment is any combination of the above embodiments, wherein the elongate member is advanced through the lumen about one minute to about 60 minutes after the enzymatic detergent has been delivered into the lumen.

[0221] A 20th embodiment is any combination of the above embodiments, wherein the elongate member is advanced through the lumen about one minute to about 10 minutes after the enzymatic detergent has been delivered into the lumen.

[0222] A 21st embodiment is any combination of the above embodiments, wherein the cleaning member comprises distal and proximal end portions and a central portion between the distal and proximal end portions, wherein the central portion is shaped to create a pressure gradient along the central portion from the distal end portion to the proximal end portion.

[0223] A 22nd embodiment is any combination of the above embodiments, wherein the enzymatic detergent comprises a component selected from the group consisting of proteases, amylases, lipases, cellulases, mannanases and combinations thereof.

[0224] A 23rd embodiment is any combination of the above embodiments, further comprising delivering the enzymatic detergent to the lumen of the medical device under pressure.

[0225] A 24th embodiment is any combination of the above embodiments, further comprising immersing the medical device within the detergent.

[0226] A 25th embodiment is any combination of the above embodiments, further comprising a connector for coupling a tube to a lumen of the endoscopic device and a power source for delivering the enzymatic detergent through the tube and the lumen of the medical device.International Patent ApplicationAttorney Docket No. : GI 099-PCT

[0227] A 26th embodiment is any combination of the above embodiments, further comprising advancing the cleaning member through the lumen of the medical device with a motor.

[0228] A 27th embodiment is any combination of the above embodiments, wherein the motor is configured to advance the elongate member through the lumen at a specific rate.

[0229] A 28th embodiment is any combination of the above embodiments, wherein the central portion of the cleaning member comprises a contraction section coupled to the proximal end portion, a diffusion section coupled to the distal end portion and a throat section coupling the diffusion and contraction sections, wherein the throat section has a diameter less than the diameter of the proximal and distal end portions and greater than a diameter of the diffusion and contraction sections.

[0230] A 29th embodiment is any combination of the above embodiments, wherein the contraction section increases in diameter from the proximal end portion to the throat section and the diffusion section decreases in diameter from the throat section to the distal end portion and wherein the throat section is substantially cylindrical.

[0231] A 30th embodiment is any combination of the above embodiments, wherein the cleaning member has one or more centering elements positioned on either end of the cleaning member for centering the cleaning member as the cleaning member is advanced through a lumen.

[0232] A 31 st embodiment is any combination of the above embodiments, comprising a system for removing biomatter from a medical device, the system comprising: a source of enzymatic detergent; a fluid delivery device for delivering the enzymatic detergent into a lumen of the medical device; and a pump having an outlet and configured to drive air through the outlet and into the lumen of medical device.

[0233] A 32nd embodiment is any combination of the above embodiments, further comprising: a tubing having a first end for coupling to the outlet and a second end; and a coupling device having a first end for coupling to the second end of the tubing and a second end configured for coupling to an opening of a lumen of the endoscopic device for delivering the air from the pump into the lumen.International Patent ApplicationAttorney Docket No. : GI 099-PCT

[0234] A 33rd embodiment is any combination of the above embodiments, wherein the pump is configured to remove pre-existing biomatter from the lumen of the medical device.

[0235] A 34th embodiment is any combination of the above embodiments, wherein the enzymatic detergent comprises a component selected from the group consisting of proteases, amylases, lipases, cellulases, mannanases and combinations thereof.

[0236] A 35th embodiment is any combination of the above embodiments, further comprising a housing, wherein the pump is disposed within the housing.

[0237] A 36th embodiment is any combination of the above embodiments, wherein the pump is configured to drive the air in pulses.

[0238] A 37th embodiment is any combination of the above embodiments, wherein the pulses have a frequency of about 10 Hz to about 120 Hz.

[0239] A 38th embodiment is any combination of the above embodiments, wherein the pump is configured to drive the air at a volumetric flow rate of about 5 Liters / minute to about 50 Liters / minute.

[0240] A 39th embodiment is any combination of the above embodiments, wherein the volumetric flow rate is about 20 to about 30 Liters / minute.

[0241] A 40th embodiment is any combination of the above embodiments, wherein the pump is configured to deliver the air at a pressure of about 1 psi to about 25 psi.

[0242] A 41st embodiment is any combination of the above embodiments, wherein the pressure is about 1 psi to about 5 psi.

[0243] A 42nd embodiment is any combination of the above embodiments, wherein the lumen comprises a valve of an endoscope.

[0244] A 43rd embodiment is any combination of the above embodiments, comprising a method for removing biomatter from a medical device, the method comprising: delivering air through a lumen of the medical device sufficient to dry the lumen; and delivering an enzymatic detergent into the lumen of the medical device.International Patent ApplicationAttorney Docket No. : GI 099-PCT

[0245] A 44th embodiment is any combination of the above embodiments, wherein the enzymatic detergent comprises a component selected from the group consisting of proteases, amylases, lipases, cellulases, mannanases and combinations thereof.

[0246] A 45th embodiment is any combination of the above embodiments, further comprising flushing the lumen of the enzymatic detergent; and delivering air through a lumen of the medical device sufficient to dry the lumen.

[0247] A 46th embodiment is any combination of the above embodiments, wherein the lumen comprises a valve of an endoscope.

[0248] A 47th embodiment is any combination of the above embodiments, wherein the air is delivered to the lumen for about one minute to about 60 minutes.

[0249] A 48th embodiment is any combination of the above embodiments, wherein the air is delivered to the lumen for about five minutes to about 10 minutes.

[0250] A 49th embodiment is any combination of the above embodiments, wherein the air in delivered pulses.

[0251] A 50th embodiment is any combination of the above embodiments, wherein the pulses have a frequency of about 10 Hz to about 120 Hz.

[0252] A 51st embodiment is any combination of the above embodiments, wherein the air is delivered at a volumetric flow rate of about 5 Liters / minute to about 50 Liters / minute.

[0253] A 52nd embodiment is any combination of the above embodiments, wherein the volumetric flow rate is about 20 to about 30 Liters / minute.

[0254] A 53rd embodiment is any combination of the above embodiments, wherein the air is delivered at a pressure of about 1 psi to about 25 psi.

[0255] A 54th embodiment is any combination of the above embodiments, wherein the pressure is about 1 psi to about 5 psi.

Claims

International Patent ApplicationAttorney Docket No. : GI 099-PCTWhat is claimed is:

1. A system for removing biomatter from a medical device, the system comprising: a source of enzymatic detergent; and a cleaning device comprising an elongate member configured for advancement through a lumen within the medical device and at least one cleaning member coupled to a portion of the elongate member, wherein the cleaning member comprises distal and proximal end portions and a central portion between the distal and proximal end portions, wherein the central portion is shaped to create a pressure gradient along the central portion from the distal end portion to the proximal end portion.

2. The system of claim 1, wherein the cleaning device is configured to remove pre-existing biomatter from the lumen of the medical device.

3. The system of claim 1, wherein the cleaning device is configured to remove a biofilm from the lumen of the medical device.

4. The system of claim 1, wherein the enzymatic detergent comprises a component selected from the group consisting of proteases, amylases, lipases, cellulases, mannanases and combinations thereof.

5. The system of claim 1, further comprising a fluid delivery device for delivering the enzymatic detergent into the lumen of the medical device.

6. The system of claim 1, further comprising a pump for delivering the enzymatic detergent under pressure.

7. The system of claim 1, wherein the device comprises a housing comprising a basin for receiving the enzymatic detergent and the medical device.International Patent ApplicationAttorney Docket No. : GI 099-PCT8. The system of claim 6, wherein the basis is configured such that the medical device is substantially immersed within the detergent.

9. The system of claim 6, further comprising a connector for coupling a tube to a lumen of the endoscopic device and a power source for delivering the enzymatic detergent through the tube and the lumen of the medical device.

10. The system of claim 8, wherein the power source is coupled to the cleaning device and configured to advance the cleaning member through the lumen of the endoscopic instrument.

11. The system of claim 9, further comprising a motor coupled to the power source and the cleaning device.

12. The system of claim 10, wherein the motor is configured to advance the elongate member through the lumen at a specific rate.

13. The system of claim 1, wherein the central portion of the drying member comprises a contraction section coupled to the proximal end portion, a diffusion section coupled to the distal end portion and a throat section coupling the diffusion and contraction sections, wherein the throat section has a diameter less than the diameter of the proximal and distal end portions and greater than a diameter of the diffusion and contraction sections.

14. The system of claim 12, wherein the contraction section increases in diameter from the proximal end portion to the throat section and the diffusion section decreases in diameter from the throat section to the distal end portion and wherein the throat section is substantially cylindrical.

15. The system of claim 1, wherein the cleaning member has one or more centering elements positioned on either end of the cleaning member for centering the cleaning member as the cleaning member is advanced through a lumen.International Patent Application Attorney Docket No. : GI 099-PCT16. The system of claim 1, wherein the lumen comprises an internal channel of an endoscope.

17. A method for removing biomatter from a medical device, the method comprising: delivering an enzymatic detergent into a lumen of the medical device; and advancing an elongate member of a cleaning device through the lumen within the medical device such that at least one cleaning member passes through the lumen in contact with an internal surface of the lumen.

18. The method of claim 16, wherein the cleaning member and the enzymatic detergent are sufficient to remove pre-existing biomatter from the internal surface of the lumen.

19. The method of claim 16, wherein the elongate member is advanced through the lumen about one minute to about 60 minutes after the enzymatic detergent has been delivered into the lumen.

20. The method of claim 16, wherein the elongate member is advanced through the lumen about one minute to about 10 minutes after the enzymatic detergent has been delivered into the lumen.

21. The method of claim 16, wherein the cleaning member comprises distal and proximal end portions and a central portion between the distal and proximal end portions, wherein the central portion is shaped to create a pressure gradient along the central portion from the distal end portion to the proximal end portion.

22. The method of claim 16, wherein the enzymatic detergent comprises a component selected from the group consisting of proteases, amylases, lipases, cellulases, mannanases and combinations thereof.

23. The method of claim 16, delivering the enzymatic detergent to the lumen of the medical device under pressure.International Patent Application Attorney Docket No. : GI 099-PCT24. The method of claim 16, further comprising immersing the medical device within the detergent.

25. The method of claim 22, further comprising a connector for coupling a tube to a lumen of the endoscopic device and a power source for delivering the enzymatic detergent through the tube and the lumen of the medical device.

26. The method of claim 16, further comprising advancing the cleaning member through the lumen of the medical device with a motor.

27. The method of claim 25, wherein the motor is configured to advance the elongate member through the lumen at a specific rate.

28. The method of claim 20, wherein the central portion of the cleaning member comprises a contraction section coupled to the proximal end portion, a diffusion section coupled to the distal end portion and a throat section coupling the diffusion and contraction sections, wherein the throat section has a diameter less than the diameter of the proximal and distal end portions and greater than a diameter of the diffusion and contraction sections.

29. The method of claim 27, wherein the contraction section increases in diameter from the proximal end portion to the throat section and the diffusion section decreases in diameter from the throat section to the distal end portion and wherein the throat section is substantially cylindrical.

30. The method of claim 20, wherein the cleaning member has one or more centering elements positioned on either end of the cleaning member for centering the cleaning member as the cleaning member is advanced through a lumen.

31. A system for removing biomatter from a medical device, the system comprising: a source of enzymatic detergent; a fluid delivery device for delivering the enzymatic detergent into a lumen of the medical device; andIntemational Patent Application Attorney Docket No. : GI 099-PCT a pump having an outlet and configured to drive air through the outlet and into the lumen of medical device.

32. The system of claim 15, further comprising: a tubing having a first end for coupling to the outlet and a second end; and a coupling device having a first end for coupling to the second end of the tubing and a second end configured for coupling to an opening of a lumen of the endoscopic device for delivering the air from the pump into the lumen.

33. The system of claim 15, wherein the pump is configured to remove pre-existing biomatter from the lumen of the medical device.

34. The system of claim 15, wherein the enzymatic detergent comprises a component selected from the group consisting of proteases, amylases, lipases, cellulases, mannanases and combinations thereof.

35. The system of claim 15, further comprising a housing, wherein the pump is disposed within the housing.

36. The system of claim 15, wherein the pump is configured to drive the air in pulses.

37. The system of claim 20, wherein the pulses have a frequency of about10 Hz to about 120 Hz.

38. The system of claim 15, wherein the pump is configured to drive the air at a volumetric flow rate of about 5 Liters / minute to about 50 Liters / minute.

39. The system of claim 22 wherein the volumetric flow rate is about 20 to about 30 Liters / minute.

40. The system of claim 15, wherein the pump is configured to deliver the air at a pressure of about 1 psi to about 25 psi.International Patent Application Attorney Docket No. : GI 099-PCT41. The system of claim 24, wherein the pressure is about 1 psi to about 5 psi.

42. The system of claim 15, wherein the lumen comprises a valve of an endoscope.

43. A method for removing biomatter from a medical device, the method comprising: delivering air through a lumen of the medical device sufficient to dry the lumen; and delivering an enzymatic detergent into the lumen of the medical device.

44. The method of claim 42, wherein the enzymatic detergent comprises a component selected from the group consisting of proteases, amylases, lipases, cellulases, mannanases and combinations thereof.

45. The method of claim 42, further comprising: flushing the lumen of the enzymatic detergent; and delivering air through a lumen of the medical device sufficient to dry the lumen.

46. The method of claim 42, wherein the lumen comprises a valve of an endoscope.

47. The method of claim 42, wherein the air is delivered to the lumen for about one minute to about 60 minutes.

48. The method of claim 42, wherein the air is delivered to the lumen for about five minutes to about 10 minutes.

49. The method of claim 42, wherein the air in delivered pulses.

50. The method of claim 48, wherein the pulses have a frequency of about11 Hz to about 120 Hz.International Patent Application Attorney Docket No. : GI 099-PCT51. The method of claim 42, wherein the air is delivered at a volumetric flow rate of about 5 Liters / minute to about 50 Liters / minute.

52. The method of claim 40, wherein the volumetric flow rate is about 20 to about 30 Liters / minute.

53. The method of claim 42, wherein the air is delivered at a pressure of about 1 psi to about 25 psi.

54. The method of claim 52, wherein the pressure is about 1 psi to about 5 psi.

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