Cleaning and drying systems for medical devices

Abstract

A cleaning or drying system for an endoscopic device comprises a wipe configured for removing matter from an exterior surface of the medical device. The wipe may comprise a cloth, such as a sterile lint-free cloth comprising a material such as polyester, microfiber or nonwoven material. The system may further comprise a pump having an outlet and configured to drive air through the outlet and a tubing having a first end for coupling to the outlet and a second end configured for delivering a sufficient amount of air to dry the exterior surface of the medical device. The system may also include a cleaning and / or drying element having an elongate member configured for advancement through a lumen of the medical device and at least one cleaning and / or drying member coupled to a portion of the elongate member.

Description

International Patent Application Attorney Docket No.: Gl 098-PCTCLEANING AND DRYING SYSTEMS FOR MEDICAL DEVICESCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application Serial No. 63 / 683,729, filed August 16, 2024, the complete disclosure of which is incorporated herein by reference in its entirety for all purposes. This application is also related to the following commonly-assigned, co-pending International Applications: (1) PCT / US2021 / 056419, filed October 25, 2021; (2) PCT / US2023 / 021156, filed May 5, 2023; (3) PCT / US2023 / 021120, filed May 5, 2023; (4) PCT / US2025 / 33855; filed June 16, 2025; (5) PCT / US2025 / 33856; filed June 16, 2025; (6) PCT / US2025 / 33859; filed June 16, 2025; and (7) PCT / US2025 / 031016; filed May 24, 2025, the complete disclosures of which are incorporated herein by reference in their entirety 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 medical application with other devices with lumens, and in non-medical applications involving the inspection, cleaning, and repair of remote locations with non-medical endoscopes and other lumens. 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, food service lines, beverage lines, pharmaceutical manufacturing lines, water filtration lines, water treatment lines, water deliver 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 processingInternational Patent Application Attorney Docket No.: Gl 098-PCT 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 across 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,International Patent Application Attorney Docket No.: Gl 098-PCT 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-use endoscopic shields to seal the complex distal end of the scope during use and initial pre-cleaning instead of leaving this area open and exposed to contamination, the use of recirculating air cabinets for overnight and extended device storage, improved adherence to reprocessing approaches, and the implementation of post-procedure 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 withoutInternational Patent Application Attorney Docket No.: Gl 098-PCT 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 multi-drug 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 procedures 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. New insights into Parkinsons which has been shown to begin in the gut and then transfer to the brain via the vagus nerve, insights into newer cancers that are shown to start with mouth bacteria and move to the gut, as well as the latest multi-society reprocessing guidelines which note that scope related patient infections are much greater than thought and more prolific in community impact with the incubation of scope related infections taking from one month to one year following patient treatment, all points the critical need to transform channel and lumen cleaning and drying, including with endoscopes. In view of all of these concerns, a new innovation is needed toInternational Patent Application Attorney Docket No.: Gl 098-PCT notably improve the effectiveness and predictability of successful cleaning of the lumens of endoscopes.

[0010] Automated endoscope reprocessors (AERs) are machines designed for the automated cleaning and high level disinfection (HLD) of reusable endoscopes and other lumenbased medical devices, such as, for example, robotic instruments. AERs replace some of the manual steps involved in endoscope reprocessing. Early AERs were designed to replace only the HLD step of endoscope reprocessing, but over time additional functions have been added. The FDA classifies AERs as medical devices that require 510(k) clearance.

[0011] Endoscopes must undergo thorough manual cleaning before placement within an AER. AERs have basins to allow endoscopes to be submerged and bathed in the HLD solution. The tubing or other connections are made between the endoscope channels and the AER using special connectors, which allow circulation of HLD solution, detergents and water under pressure through the channels, thus exposing interior channels and outside surfaces of the endoscope to the HLD solution, detergents and water. The AER circulates the HLD solution continuously during the exposure period or cycle time, which for a scope or other device, typically varies from 22 to 30 minutes.

[0012] After completion of the detergent and again after HLD cycle, AERs automatically rinse the reprocessed endoscope with water to remove the detergents and toxic HLD solution residues. After the last water flush, some AERs then flush the endoscope channels with forced air or with 70% to 80% ethyl or isopropyl alcohol followed by forced air to aid in drying the endoscope channels to prevent growth of waterborne pathogenic microorganisms during storage.

[0013] AERs offer several advantages over manual reprocessing. They automate and standardize several important reprocessing steps, thereby eliminating the possibility of missed steps because of human error, and minimizing exposure of endoscopy or sterile processing department personnel to HLDs or chemical sterilants. A prospective study evaluating the impact of human factors and automation on endoscope reprocessing indicated that use of AERs was associated with increased consistency and compliance with endoscope reprocessing guidelinesInternational Patent Application Attorney Docket No.: Gl 098-PCT and inversely associated with skipped steps during reprocessing. Furthermore, use of AERs reduced a number of health problems attributed to reprocessing among personnel involved in HLD. As a result of automation of several reprocessing steps, AERs may also reduce work related repetitive movements that can potentially cause bodily injury.

[0014] One of the limitations that exists with current AER machines used to clean and dry the internal lumens of endoscopes is the lack of a collaborative and complementary element between the two technologies used for the manual cleaning, disinfection and / or drying steps that are the key stages with current device reprocessing requirements. For example, all reusable endoscope manufacturers require as a first step in the cleaning process that the endoscope be placed in a fluid that is formulated to assist with the removable of biomatter and debris, followed by brushing the internal channels while the scope is immersed in the cleaning fluid. Multiple formulations of cleaning fluids exist, but the most commonly used are either an enzymatic detergent, or a ph-neutral non-enzymatic detergent. The cleaners are intended to loosen the adhesion of biomatter and bacteria to the walls of the channel, though this is not effective on its own and even with brushing, evidence exists that not all biomatter is consistently removed, failing 25% or more of the time even with 100% compliance in following the requisite processing steps.

[0015] The manual cleaning processes designed to prepare the endoscope for the AER typically involve advancing a cleaning brush from the proximal end of the scope at the opening of the biopsy channel, down the channel to the distal end of the scope, where instruments exit the scope inside the patient and / or other channels. This approach means that any biomatter, debris, bacteria and other contaminants present in the channel are pushed from the proximal end of the scope, which is the least complex part of the scope to clean, to the distal tip of the scope, which is the most complex part of the scope to successfully clean and reprocess, and which is the area that has been linked to the most scope-related infections and deaths. In essence, the cleaning brush acts as a tool that not only partially removes debris in the channel, but it also shovels or pushes contaminates out of the biopsy channel into the most difficult to clean area on the scope, with the highest level of scope-related infection risk. Logically, one would want to do everything possible to do the opposite of what is currently done with the direction for passingInternational Patent Application Attorney Docket No.: Gl 098-PCT cleaning brushes through the biopsy channel and suction channel (i.e. pass from distal end to proximal end exit of the biopsy channel). This current approach with brushes occurs with certain complex scopes, such as duodenoscopes, because of limitations with current technologies, including, by way of example not limitation, demonstrated issues where the complex distal end of the scope resulting in the wire bristle brush becoming stuck at the distal end and therefrom becoming not advanceable to clean the scope’s biopsy / working channel.

[0016] In addition to this limitation, the cleaning brushes themselves also have a number of notable limitations that inhibit consistent, repeatable scope reprocessing success. Pictures of brushes and squeegees show that these designs are not able to consistently contact the internal lumen, which is their essential cleaning function. In addition, pictures of the interior of the scope biopsy channels after cleaning with a nylon wire bristle brush reveals that the bristles deflect while being passed through the channels, losing wall contact along the interior of the channels rather than achieving a clean consistent cleaning result. These channels can be highly contaminated with debris, biomatter and bacteria after experiencing repeated passing of therapeutic instruments during procedures, as well as from the actuation of suction to remove debris, mucus and other biomatter during a procedure. Using brushes that deflect and cause streaks means that channel cleaning is incomplete and will be highly variable. In addition, trying to offset this limitation through the use of repeated nylon wire bristle brush passes, which is recommended by the scope manufacturers, does not overcome this issue (as the same defective action is repeated), and does not result in in a predictably and completely clean channel. Data from multiples sources indicates that the combination of repeated passes using a stiff bristle brush causes injury to the surface of the interior endoscope channel, as the bristles create scratches and crevasses from the effects of the multiple wire passes. These scratches and crevasses allow bacteria and biomatter to infiltrate and reside in these new spaces even with multiple brush passes to clean the scope after the next case, limiting the consistency of the cleaning result and thereby inhibiting the ability of disinfectants and sterilants to successfully disinfect and sterilize the scope to safely return it for use in the next case. All biomatter and debris must be successfully removed in order to successful disinfection and reprocess a scope. Left behind biomatter and debris acts as a shield over pathogens that may reside in these channels (including naturally occurring bacteria from the patient) preventing successfulInternational Patent Application Attorney Docket No.: Gl 098-PCT treatment with disinfectants and sterilants that need direct contact to kill the pathogens and make the scope safe for reuse with the next patient.

[0017] With respect to drying the lumens after cleaning and disinfection, AERs also suffer from a number of drawbacks. AERs typically flush the endoscope channels with forced air or with 70% to 80% ethyl or isopropyl alcohol followed by forced air to aid in pursing fluid from the endoscope channels, though AER manufacturers clearly state that their AERs can only partially purge and cannot dry the channels fully and completely, which is required to prevent growth of waterborne pathogenic microorganisms during storage. The channels are flushed with alcohol, under the premise this may accelerate drying and act as an additional bacteriostatic agent (though the instrument in medical applications had already been disinfected or sterilized at this point). Data shows this does not clearly accelerate drying times or drying effectiveness and can even lengthen the drying process in certain instants. In addition, there are concerns that the use of alcohol may actually fixate certain otherwise inert or innocuous bacteria and pathogens in the channel that in turn can be passed on to the patient or user in certain circumstances.

[0018] In addition, using forced air to dry the channels has variable results, which is due, at least in part, to the distance that the air must travel to dry the channel, the variable channel diameters of the channels, which impact the air velocity, and the surface tension of the water, which can be greater than the force of the air at different points, preventing effective and timely removal of the water. Additionally, the tight spaces, curves and junctions essentially trap or help retain moisture and promote a humid environment, inhibiting evaporation and effective drying. Challenges beyond even these significant difficulties include endoscopes and other instruments with curved internal channels and lumens where one or more channels come together creating even more variable surfaces, such as Y-junctions and connectors where water can pool and areas adjacent to and / or outside of valves that interact with a channel, all making air flow and related drying success very difficult to achieve without prolonged timeframes that are not matched with clinical requirements.

[0019] Thus, a new innovation is needed that addresses the notable limitations of current technologies and that can actively complement and work-in-concert with the cleaning fluids, detergents, sterilants, and water flushing used in AERs and other infection preventionInternational Patent ApplicationAttorney Docket No.: Gl 098-PCT approaches to effectively clean or disinfect / sterilize these channels. In addition, a new innovation is needed to address the limitations of current AERs and sterilizers in cleaning and drying the channels after they have been cleaned so that the channels and lumens can be effectively sterilized or disinfected. In particular, it would be desirable to provide automated devices that can effectively clean and / or dry all internal surfaces of endoscopic technologies, including crevasses, Y-junctions, and scratches or other irregularities, without further damaging these surfaces.SUMMARY

[0020] Systems, kits, devices and methods are provided for cleaning and / or drying endoscopic and / or cataract and other eye surgery and other medical devices, such as endoscopes, particularly internal lumens, or other spaces within the endoscopic instruments, after they have been cleaned. 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 with lumen(s) that in-dwell, penetrate and / or navigate in the body, as well as non-medical applications to clean and / or dry other lumens.

[0021] In one aspect, a drying system for a medical device comprises a wipe configured for removing matter from an exterior surface of the medical device; a pump having an outlet and configured to drive air through the outlet and a tubing having a first end forInternational Patent Application Attorney Docket No.: Gl 098-PCT coupling to the outlet and a second end configured for delivering a sufficient amount of air to dry the exterior surface of the medical device.

[0022] In embodiments, the wipe comprises a cloth, fabric, textile, swab, gauze or the like. In an exemplary embodiment, the wipe comprises a sterile lint-free cloth. The cloth may comprise any suitable material, including but not limited to, polyester, microfiber and nonwoven materials. The wipe may include other components, such as isopropyl alcohol, water, deionized water, bleach, peroxide, sodium hypocholorite, sodium chloride, sodium carbonate, sodium hydroxide and combinations thereof.

[0023] 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.

[0024] 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.

[0025] 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,International Patent Application Attorney Docket No.: Gl 098-PCT the majority of the “drying action” comes from displacement, rather than evaporation, using volumetric air in higher levels than approaches focused on psi.

[0026] In addition, Applicant has discovered driving the air at lower pressures in the ranges above and correspondingly higher 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 or less than 30 seconds. In an exemplary embodiment, some channels may be substantially dried in about 20 seconds.

[0027] 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.

[0028] In another aspect, the system further includes a drying device having an elongate member configured for advancement through a lumen within the endoscopic instrument and a drying element coupled to at least a portion of the elongate member. The drying element includes certain portions that have an outer diameter equal to or greater than the diameter of the lumen.

[0029] In various embodiments, elongate member and / or the drying member(s) may be configured to be reusable or disposable. The 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, a device with partial or offsetting lateral fins or another absorbent and / or displacing device.

[0030] In various embodiments, the elongate member of drying 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 Application Attorney Docket No.: Gl 098-PCT be grasped at an end once it is pulled through the internal channel and then pulled through the channel as part of the drying process. It also can be advanced from the other end through pushing the advancement element.

[0031] In another aspect, a cleaning system for a medical device comprises a wipe configured for removing matter from an exterior surface of the medical device and a cleaning element having an elongate member configured for advancement through a lumen of the medical device and at least one cleaning member coupled to a portion of the elongate member.

[0032] In embodiments, the wipe comprises a cloth, fabric, textile, swab, gauze or the like. In an exemplary embodiment, the wipe comprises a sterile lint-free cloth. The cloth may comprise any suitable material, including but not limited to, polyester, microfiber and nonwoven materials. The wipe may include other components, such as isopropyl alcohol, water, deionized water, bleach, peroxide, sodium hypocholorite, sodium chloride, sodium carbonate, sodium hydroxide, detergent, disinfectant, sterilant, and combinations thereof.

[0033] In one embodiment, the cleaning and / or drying 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 and / or drying member and any air and / or fluid within the lumen as the cleaning and / or drying member is advanced through the lumen. The increased velocity of the air and / or fluid increases the shear stress between the air and / or fluid and the lumen wall, thereby creating more force to dry the wall.

[0034] In embodiments, the proximal and distal end portions of the cleaning and / or drying 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 elements preferably have a substantially circumferential, cylindrical or conical shape with atInternational Patent Application Attorney Docket No.: Gl 098-PCT 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 drying element and the internal wall of the lumen.

[0035] The variable pressure central portion of the cleaning and / or drying member is designed to create variable pressure between the two circumferential elements and the wall of the channel being cleaned. Thus, as the cleaning and / or drying member is advanced inside a channel and the scope and its channels, the variable pressure design between the two circumferential elements creates a venturi effect between the cleaning and / or drying element and the walls of the endoscope channel when the cleaning and / or drying element is moved through the lumen.

[0036] In certain embodiments, the central portion of the cleaning and / or 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. 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.

[0037] 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 dried or cleaned, thereby increasing the force against the channel wall when the cleaning and / or drying 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 and / or other variable pressure effect between the distal and proximal end portions of the drying element.

[0038] In certain embodiments, the cleaning device / element includes more than one cleaning and / or drying member. For example, in one such embodiment, the cleaning and / orInternational Patent Application Attorney Docket No.: Gl 098-PCT drying device includes 2-10 cleaning and / or drying members, preferably 2-5 cleaning and / or drying members. The cleaning and / or drying members may be coupled to each other to provide a string of such cleaning and / or drying 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 and / or drying member may be coupled to, or may be integral with, the distal end portion of the next cleaning and / or drying member along the string. Each of the cleaning and / or drying 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 and / or drying 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 and / or drying 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.

[0039] In another aspect, an automated cleaning system for an endoscopic device comprises a wipe configured for removing matter from an exterior surface of the medical device, a housing comprising a basin for receiving the endoscopic device, a connector for coupling a tube to a lumen of the endoscopic device and a source of fluid. The system further comprises a power source and a pump or other device for delivering the fluid through the tube and the lumen of the endoscopic device and a cleaning device comprising an elongate member configured for advancement through the lumen of the endoscopic device and at least one cleaning member coupled to a portion of the elongate member. The device may further comprise a control arm for advancing the elongate member, such as a push or pull arm.

[0040] 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, tissue, debris, contaminants and / or pathogens 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 elongateInternational Patent Application Attorney Docket No.: Gl 098-PCT 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.

[0041] 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 moisture and otherwise dry the channel. The fluid may comprise any suitable cleaning fluid, such as an enzymatic cleaner, disinfectant or a ph-neutral non-enzymatic cleaner. In an exemplary embodiment, the formulations comprise one or more detergents, followed by disinfectants with one or more of glutaraldehyde, thophthalaldehyde, peracetic acid, chlorine, hydrogen peroxide, phenol / phenate, alcohol, microbicidal agents or the like.

[0042] In various embodiments, the system may further comprise a control arm, robotic arm, circular or looping arm, pushing / pulling member, wire or other device for controlling the cleaning device. The cleaning and / or drying device may be positioned in, for example, a loop or track and may comprises various sizes to match the internal diameter of the channel(s) within the endoscopic device. The cleaning and / or drying device may be sterile or disinfected, in a cartridge or other container, pouch or bag.

[0043] In various embodiments, the power source comprises a motor or other nonhuman actuator configured for coupling to the cleaning and / or drying device and advancing the elongate member and the cleaning and / or drying member through the channel(s) of the endoscopic device to clean / remove debris and later moisture. 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 fluid and / or air jet that advances the cleaning and / or drying member(s) through the channels while delivering fluid and / or air therethrough. The fluid and / or air jet and / or the cleaning and / or drying member may comprise a centering element (as described below).International Patent Application Attorney Docket No.: Gl 098-PCT

[0044] 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. 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 and later disinfectant, sterilant, flushing liquid such as water and / or moisture.

[0045] In various embodiments, the cleaning and / or drying system further comprises a fluid delivery device configured to deliver a fluid and / or air through the lumen of the endoscopic device. The fluid may include, depending on the stage of the process, water, detergent (enzymatic or non-enzymatic), disinfectant or other neutral flushing agent, such as water, alcohol or any other liquid, gas or non-liquid medium. In an exemplary embodiment, the cleaning formulations comprise one or more detergents and a disinfectant / sterilant of glutaraldehyde, thophthalaldehyde, peracetic acid, chlorine, hydrogen peroxide, phenol / phenate, alcohol, microbicidal agents, plasma, gas, or the like.

[0046] 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 or pulling elements to a valve, valve entrance, or port 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).

[0047] In another aspect, an automated drying system for an endoscopic device comprises a wipe configured for removing matter from an exterior surface of the medical device and a 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 and a power source coupled to the drying device and configured to advance the drying member through the lumen of the endoscopic device.International Patent Application Attorney Docket No.: Gl 098-PCT

[0048] In various embodiments, elongate member and / or the drying member(s) may be configured to be reusable or disposable. The 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 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.

[0049] 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.

[0050] In an exemplary embodiment, the motor is configured to advance the 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 drying member moves at a velocity suitable for effectively removing moisture, debris or other contaminants from the channels in an endoscope

[0051] In various embodiments, the drying system further comprises a fluid delivery device configured to deliver a fluid and / or air through the lumen of the endoscopic device. The fluid may comprise any suitable drying fluid, air, gas or matter, such as hepa filter air, ethyl or isopropyl alcohol or combinations thereof.

[0052] In various embodiments, the fluid, gas or air 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 or port of an endoscope,International Patent Application Attorney Docket No.: Gl 098-PCT 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. 3A 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 Application Attorney Docket No.: Gl 098-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 “cleaning fluid jet” or “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;International Patent Application Attorney Docket No.: Gl 098-PCT

[0075] FIG. 19 illustrates the “sweep” action of the cleaning and / or drying element of FIG. 15;

[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 associatedInternational Patent Application Attorney Docket No.: Gl 098-PCT 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 be 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] 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 / sterilization 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 Application Attorney Docket No.: Gl 098-PCT

[0087] 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.

[0088] 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.

[0089] 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

[0090] 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), urethraInternational Patent Application Attorney Docket No.: Gl 098-PCT(cystoscope), abdomen and peritoneal cavity (laparoscope), nose and sinus (laryngoscope), anus (sigmoidoscope) and other aspects of the gastrointestinal tract (gastroscope, 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.

[0091] 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).

[0092] Referring now to FIG. 1, a drying system 10 comprises a drying device 200, a powered dryer 30, a connector element 40 and an endoscope coupling device 50, which may be sterile. Drying device 200 comprises a sterile, direct-to-channel drying apparatus that may be used to rapidly dry 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, which in embodiments may be between 0.,5 and 5.0 mm in diameter. The connector element 40 comprises a filtered air tubing set with a high efficiency particulate air (HEP A) filter 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-H0L, EC38-il0L, EG34-ilO, EG38-J10UT, EC 3890Li, EC3890Zi, G-International Patent Application Attorney Docket No.: Gl 098-PCTEYE38-ilOF2, G-EYE38-ilOL / F, G-EYE34ilOL / 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 EG29ilO, ED32ilO and EC34TH, EC34-ilOTL, EC34-ilOTF, 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-AL5 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.

[0093] As shown in FIG. 2, drying device 200 comprises an elongate tube or filament 22 having an insertion end 24 and a drying element 300 on the opposite end of filament 22 from insertion end 24. Certain preferred embodiments of 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 device could be, in embodiments, a variable pressure device or a squeegee, wire, sponge, balls or other absorbent or displacing device to remove moisture.

[0094] Referring now to FIG. 3, 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 102International Patent Application Attorney Docket No.: Gl 098-PCT 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.

[0095] As shown, strap 1 10 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 112 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 opening 109 spaced longitudinally from each other on distal end 112 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.

[0096] Handle 100 further includes a nozzle 112 extending from main body 102 (see FIG. 9A) 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).

[0097] 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 volume and air flow within these channels to remove all or substantially all of the moisture therein.

[0098] 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 presetInternational Patent Application Attorney Docket No.: Gl 098-PCT 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.

[0099] 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.

[0100] 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.

[0101] 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.

[0102] 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.International Patent Application Attorney Docket No.: Gl 098-PCT

[0103] In use, drying system 10 is particularly useful for rapidly dying the internal channels of endoscopes, particularly, the smaller or micro-channels 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 and / or air or gas 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 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.

[0104] 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.

[0105] 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 useInternational Patent Application Attorney Docket No.: Gl 098-PCT with a scope in a lumen. Alternatively, endoscope 120 may include a separate working channel or a dual working channel for these instruments.

[0106] Referring now to FIGS. 7-13, a method for drying one or more of the internal channels of endoscope 120 will now be described. 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. 9A. 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.

[0107] 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. In a further embodiment, a moisture sensor may be part of the system and the powered dryer may run until the moisture sensor provides a signal turning off the dryer. The moisture sensor may singular or a plurality of sensors that may be placed at the exit of a lumen or channel or inside the lumen or channel to detect and measure moisture levels. In embodiments, the sensitivity of this test could be between .5 ii L of moisture and .01 / / L of water, with an exemplary embodiment of less than 0.05 ii L of moisture.

[0108] 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 insertedInternational Patent Application Attorney Docket No.: Gl 098-PCT 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.

[0109] 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, gas, plasma or other matter 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.

[0110] Referring now to FIGS. 10A and 10B, the endoscope channels may also be dried by drying device 200. In some cases, 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, or used in combination on certain devices, lumens and channels.

[0111] 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.

[0112] Referring now to FIG. 15, an exemplary drying element 300 for device 200 will now be described. It should also be noted that drying device 200 may also be used for cleaning, disinfecting, sterlizing and / or removing biomatter, debris and / or pathogens from endoscopicInternational Patent Application Attorney Docket No.: Gl 098-PCT 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.

[0113] 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.

[0114] 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 internal 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.

[0115] 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, contactInternational Patent Application Attorney Docket No.: Gl 098-PCT elements 302, 304 are about 0.75 mm in width or thickness and taper to about 0.5 mm at their tips (or the point of contact with the internal wall of the lumen).

[0116] 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 or immersed in cleaning fluid, such as a detergent or disinfectant / sterilant, (as required by scope manufacturers, which may also be saline or any other biocompatible material safe to use with an in-dwelling catheter), the variable pressure design between the two circumferential elements creates a venturi effect between the cleaning / 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 fluid or air / gas flows across the variable pressure area, as applicable, this impacts the fluid or air / gas 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 drying a lumen, these forces allow the cleaning and / or drying element to substantially remove all fluid and moisture from within the lumen (or contaminants when cleaning).

[0117] 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 / gas or fluid flows across the variable pressure area, this impacts the fluid or air / gas 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.

[0118] 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 theInternational Patent Application Attorney Docket No.: Gl 098-PCT 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 / gas or fluid by turning the air / gas or fluid 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 / gas or fluid is enhanced through drying / cleaning member’s direction of the air / gas or fluid at the walls of the scope channel with pressure.

[0119] 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, disinfected, sterilized and dried, as applicable, thereby increasing the force by which the fluid and / or air / gas is projected at the channel wall when the cleaning and / or drying member is advanced.

[0120] 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.

[0121] In a preferred embodiment, variable pressure region 306 has an external or inverted, partial venturi shape with three distinct areas of various spacing from the wall of the scope channel, which creates accelerated aerodynamic / fluid dynamic action projecting air / fluid at the channel wall to dry or clean, as applicable, more effectively. These areas include a contraction section 308, which is the start of the area where air is present on the other side of the first cylindrical element. The contraction section 308 is the start of the area in which fluids and / or air (and other gases or plasma) accumulate and are subject to changing pressure as the space available for the fluid and / or air / gas varies and becomes smaller as drying and / or cleaning element 300 is advanced and the fluid and / or air, as applicable, is directed into the throat section 310 that further alters the pressure between the cleaning / drying element and the channel wall. The throat section 310, wherein the shape available for the air / gas and / or fluid is reduced further in a manner that changes the pressure on the air and / or fluid compared to the pressure on the airInternational Patent Application Attorney Docket No.: Gl 098-PCT and / or fluid in the contraction section, creates an acceleration of the air / fluid as the drying and / or cleaning element 300 is advanced; followed by a diffusion section 312 which supports the diffusion of the air and / or fluid at an accelerated speed as it exits the throat section. Collectively, these sections between the cylindrical elements create an aerodynamic force for air or fluid dynamic force for fluid sufficient to remove substantially all moisture and fluid from the lumens during a drying process and / or create a hydrodynamic force to remove contamination during a cleaning process.

[0122] 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 or dried, the viscosity of the thickness of the fluid and / or air and other factors and should be sufficient to support a variable pressure flow of fluid and / or air between the cylinders when the cleaning / drying element, as applicable, 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.

[0123] 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 or dried, the viscosity of the fluid or air and other factors, and should be sufficient to support a variable pressure flow of fluid or air 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.

[0124] 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 and other factors. For example, in a lumen having aInternational Patent Application Attorney Docket No.: Gl 098-PCT 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).

[0125] The venturi effect created by variable pressure region 306 impacts the air or fluid 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 or fluid 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 air or fluid 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, as well as delivery disinfectant and sterilants.

[0126] When the drying and / or cleaning element is advanced through a lumen having a fluid therein, the variable pressure region of the drying and / or cleaning element is configured to generate air and / or 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 drying and / or cleaning element. This peak pressure 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.

[0127] 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 endInternational Patent Application Attorney Docket No.: Gl 098-PCT portions of the 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.

[0128] The variable pressure region of the 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 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 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.

[0129] 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 moisture 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.

[0130] 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 drying pressure, thereby increasing the amount of moisture that can be removed 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 thisInternational Patent Application Attorney Docket No.: Gl 098-PCT 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%.

[0131] 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 cleaning fluid 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.

[0132] 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 or fluid 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.

[0133] 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 or fluid 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.

[0134] 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.International Patent Application Attorney Docket No.: Gl 098-PCT

[0135] 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).

[0136] 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 in contact with the channel and, in embodiments 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.

[0137] If the cylindrical elements are too high in diameter relative to the channel size and contact with the channel, this can result in ineffective cleaning or drying due to gaps in the cylinders, deflection of the cleaning / drying device, and / or 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.

[0138] 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 200 may also allow for passing through the scope channel in the opposite direction, from proximal to distal.International Patent Application Attorney Docket No.: Gl 098-PCT

[0139] 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 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.

[0140] 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.

[0141] 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 ofInternational Patent Application Attorney Docket No.: Gl 098-PCT cleaning / drying element 300. In embodiments, 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 cleaned and / or 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 10 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.

[0142] In certain embodiments, cleaning / 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.

[0143] Referring now to FIG. 16B, one embodiment of a cleaning and / or drying device 400 with multiple cleaning / drying elements 300 will now be described. As shown, each cleaning / drying element 300 includes proximal and distal end portions 302, 304 and a variable pressure region 306 there between, 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 cleaned / dried (as discussed in detail below). In thisInternational Patent Application Attorney Docket No.: Gl 098-PCT embodiment, the cleaning / drying elements are coupled to each other at the proximal and distal end portions. In an exemplary embodiment, the proximal end portion of one cleaning / drying element is integral with the distal end portion of the next cleaning / drying element, although it will be recognized that other configurations are possible. For example, cleaning / 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 / drying element 300 and the wall of the channel being cleaned and / 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.

[0144] 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 and / 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 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.

[0145] In embodiments, each cleaning / drying element 300 is between 2.5 cm and 7.5 cm long and cleaning / drying device 400 contains multiple variable pressure areas separated by multiple cylindrical elements. In a preferred embodiment, cleaning / drying device 400 contains five variable pressure areas separated by six cylindrical elements. In certain embodiments, cleaning / drying device 400 may include two additional cylindrical elements 402, 404 at a distal end of the device 400, which may be centering elements and / or variable pressure elements, or a combination thereof.International Patent Application Attorney Docket No.: Gl 098-PCT

[0146] 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 there between, as described above. The proximal and distal end portions 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) or cleaned. In this embodiment, the drying and / or cleaning elements are coupled to each other at the proximal and distal end portions. In an exemplary embodiment, the proximal end portion of one drying and / or cleaning element is integral with the distal end portion of the next drying and / or cleaning element, although it will be recognized that other configurations are possible.

[0147] 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 and / or cleaning device. Drying and / or cleaning members 422 are substantially cylindrical and, therefore, do not include the variable pressure region discussed above.

[0148] 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. 16A) 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 and / or cleaned, 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 and / or cleaning device as it is pulled or pushed around curves, corners and junctions of various lumens (including Y junctions).

[0149] 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 pushed and / or pulled to oneInternational Patent Application Attorney Docket No.: Gl 098-PCT side of the lumen as they are advanced around curves, comers 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 cleaning and / or drying, especially around curves, corners, channel junctions and other complex areas inside an endoscope or other endoscopic instrument or device.

[0150] In some embodiments, drying and / or cleaning element 424 may comprise a series of shaped elements projecting 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 and / or cleaning elements within the internal channel of the endoscopic device.

[0151] In a preferred embodiment, centering element(s) 424 are between 50 percent and 90 percent of the diameter of the lumen being dried and / or cleaned, with a further preferred embodiment having a diameter or height between 70 percent and 85 percent of the diameter of the lumen being dried and / or cleaned. Centering element(s) 424 can be any shape that preserves the centering of the drying and or cleaning 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 and / or cleaning members, or the proximal end, as appropriate to aid in centering the drying and / or cleaning element, especially as it navigates around curves, across Y-junctions and other aspects of a lumen.

[0152] 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 theInternational Patent Application Attorney Docket No.: Gl 098-PCT 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 advances the elongate member and includes a moving internal waterjet that advances the cleaning and / dry member(s) through the channels while delivering fluid and / or air therethrough. The waterjet and / or the cleaning member may comprise a centering element (as described below).

[0153] 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 user 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.

[0154] In various embodiments, the cleaning and / or drying system further comprises a fluid, gas, air, plasma delivery device, as applicable, configured to deliver a fluid, gas or plasma matter 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 / sterilization formulations comprise one or more of glutaraldehyde, thophthalaldehyde, peracetic acid, chlorine, hydrogen peroxide, phenol / phenate, alcohol, microbicidal agents or the like in liquid, gas, plasma or other matter. Alternatively, or in addition, the fluid may comprise any suitable drying fluid, gas, plasma or other matter, such as air, ethyl or isopropyl alcohol, plasma gas, or combinations thereof.

[0155] In various embodiments, the fluid, gas, air, plasma delivery device comprises a pump for delivering the fluid, gas, air, plasma 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 anInternational Patent Application Attorney Docket No.: Gl 098-PCT endoscope, such as an air valve, water valve, biopsy valve, suction valve, or an opening to a working channel of the endoscope.

[0156] In embodiments, the delivery of air or fluid is determined through an equation (FIG. 30) in which the water mass transfer rate from the lumen is proportional to the cubic square root of the air volume flow rate through the lumen, as well as the water concentration profile.

[0157] Referring now to FIGS. 21-26, another embodiment of an automated cleaning and / or drying system 600 for cleaning, disinfecting, sterilizing, 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 drying system 10, the powered dryer 30, the endoscope coupling element 50 and / or the connector 40.

[0158] 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 drain 612 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 EVOTECH™ AER and 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, the Soluscope™ AER sold by Ecolab Corporation, or similar such systems.

[0159] Automated system 600 may be used to clean, disinfect, sterilize and / or dry a variety of different reusable endoscopic and / or lumened devices, including, but not limited to,International Patent Application Attorney Docket No.: Gl 098-PCT respiratory tract endoscopes, urinary tract endoscopes, gastro-intestinal endoscopes, duodenoscopes with a sealed elevator channel, duodenoscopes with an open elevator channel and the like.

[0160] 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, gas, plasma or other matter 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, gas or plasma or other matter 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, gas, plasma or other matter, such as air, ethyl or isopropyl alcohol or combinations thereof.

[0161] 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 may also include a sterilization cycle. The system automatically delivers fluid, gas, plasma or other matter, or a combination thereof, under pressure through the channels of the endoscope to clean, disinfect, sterilize and dry these channels.

[0162] In one embodiment, cleaning 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, disinfectant, sterilant, and / or drying fluid, gas, plasma or other matter, is delivered therethrough. In this embodiment, cleaning device 200 may be manually orInternational Patent Application Attorney Docket No.: Gl 098-PCT automatically advanced through the channels while the fluids, gas, plasma or other matter 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 or device. Cleaning device 200 may also be advanced or retracted with a robotic arm, wire, wire and pully system or other devices. The cleaning device may pass through a flushing or rinsing area after each channel pass to remove any debris before the next pass. In embodiments, the drying device may pass through a drying area (by air or contact or other means) to remove moisture before the next pass.

[0163] 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).

[0164] System 600 may further include a controller, computer device, processor or the like that controls the combined cleaning, disinfection, sterilization and / 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 be configured to control both the velocity of the cleaning or drying device and the parameters of the fluid, gas, plasma or other matter, such that each modality works together to increase the overall efficiency of the cleaning, disinfection, sterilization and / or drying operation.

[0165] 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 mayInternational Patent Application Attorney Docket No.: Gl 098-PCT 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.

[0166] The cleaning and / or drying device may be provided sterile. Sterilization may be accomplished by any method known in the art, including ETO, gamma, E-Beam, steam, heat, 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.

[0167] 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 the automated detergent infusing, water flushing, disinfectant infusing and water flushing steps with the AER, which may be repeated multiple times.

[0168] 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 theInternational Patent Application Attorney Docket No.: Gl 098-PCT 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 / or water flush resulted in an undetectable contamination score with conventional sensitive assays (i.e., the protein assay did not reveal any protein contaminants or other debris in the channels). After completing this step (Step 2 of Revised Approach #1), the device is subjected to steps 3-5 of the conventional reprocessing sequence, as described above and the initial pre-clean step is removed, saving time, water and detergent.

[0169] In an alternative method illustrated from FIG. 26 and FIG. 27, the pre-clean step is performed (Step 1), but the manual cleaning step 2(submerge and manually clean the channels in ten gallons of detergent and then water flushing), is eliminated and instead incorporated into automated cleaning with a channel cleaning device in an AER, reducing the amount of detergent and water flushing by, in embodiments, at least 33 and up to 66%, which would save between 5 to 10 gallons of water, as well as significant detergent, for each endoscope that is reprocessed.

[0170] 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 and detergent. An automated leak test is performed and then the automated cleaning and / or drying devices described herein are advanced through the internal channels as part of the cleaning, disinfecting / sterilization and drying process. This method substantially reduces the water required to flush the scope channels of detergent, water, disinfectant and sterilant, thereby reducing the duration of the process, which reduces water and detergent consumption and wear and tear on the components of the AER, as well as wear and tear on the scope channels from the pressure involved in repeatedly flushing the channels.

[0171] 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 immediatelyInternational Patent Application Attorney Docket No.: Gl 098-PCT placed into the AER and the internal channels are fdled with water. The cleaning and / or drying devices described herein are advanced through the internal channels with the device to be cleaned within the AER. 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. This also means a scope with dry channels is present at the end of the AER cycle, which does not occur with current technology, which performs an air purge, but cannot dry the device completely.

[0172] 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.

[0173] 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.

[0174] 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 ETO, chemical, E-Beam, hydrogen peroxide, steam, heat, gamma irradiation or the like. The cleaning wipe may include other components, such as isopropyl alcohol, water,International Patent Application Attorney Docket No.: Gl 098-PCT deionized water, bleach, peroxide, sodium hypocholorite, sodium chloride, sodium carbonate and / or sodium hydroxide. The cleaning wipe may be single, double or triple bagged to maintain sterility before use.

[0175] The system of kit may further include a cleaning and drying device 200 and / or a powered dryer 30, as shown in FIG. 1 .

[0176] 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 connected 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 to deliver fluid, air, plasma or other matter.

[0177] 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 or shorter or longer based on the dimensions of the channel. 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. In embodiments, a moisture sensor (not shown) may be placed at the end of a channel to be dried and the powered dryer connected to the other end and the dryer run until the moisture sensor signals no moisture is present and turns off the powered dryer.

[0178] 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.

[0179] Hereby, all issued patents, published patent applications, and non-patent publications that are mentioned in this specification are herein incorporated by reference in theirInternational Patent Application Attorney Docket No.: Gl 098-PCT 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.

[0180] 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 description is not to be limited by what has been particularly shown and described, except as indicated by the appended claims.

[0181] For example, in a first aspect, a first embodiment is a drying system for a medical device. The system comprises a wipe configured for removing matter from an exterior surface of the medical device, a pump having an outlet and configured to drive air through the outlet and a tubing having a first end for coupling to the outlet and a second end configured for delivering a sufficient amount of air to dry the exterior surface of the medical device.

[0182] A second embodiment is the first embodiment, wherein the wipe comprises a cloth.

[0183] A third embodiment is any combination of the above embodiments, wherein the wipe comprises a sterile lint-free cloth.

[0184] A 4thembodiment is any combination of the above embodiments, wherein the wipe comprises a material selected from the group consisting of polyester, microfiber and nonwoven material.International Patent Application Attorney Docket No.: Gl 098-PCT

[0185] A 5thembodiment is any combination of the above embodiments, wherein the wipe comprises one or more components selected from the group consisting of isopropyl alcohol, water, deionized water, bleach, peroxide, sodium hypochlorite, sodium chloride, sodium carbonate and sodium hydroxide.

[0186] A 6thembodiment is any combination of the above embodiments, further comprising a housing, wherein the pump is disposed within the housing.

[0187] A 7thembodiment is any combination of the above embodiments, wherein the pump is configured to drive the air in pulses.

[0188] An 8thembodiment is any combination of the above embodiments, wherein the pulses have a frequency of about 10 Hz to about 120 Hz.

[0189] A 9thembodiment is any combination of the above embodiments, wherein the frequency is about 60 Hz.

[0190] A 10thembodiment is any combination of the above embodiments, further comprising 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.

[0191] An 11thembodiment is any combination of the above embodiments, further comprising a drying element having an elongate member configured for advancement through a lumen of the medical device and at least one drying member coupled to a portion of the elongate member.

[0192] A 12thembodiment is any combination of the above embodiments, wherein the drying element 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 Application Attorney Docket No.: Gl 098-PCT

[0193] A 13thembodiment is any combination of the above embodiments, further comprising a power source coupled to the drying element and configured to advance the drying element through the lumen of the medical device.

[0194] A 14thembodiment is any combination of the above embodiments, further comprising a motor coupled to the power source and the cleaning device.

[0195] A 15thembodiment is any combination of the above embodiments, further comprising a fluid delivery device configured to deliver a fluid through the lumen of the medical device.

[0196] A 16thembodiment is any combination of the above embodiments, wherein the fluid delivery device comprises a pump for delivering the fluid under pressure.

[0197] A 17thembodiment is any combination of the above embodiments, wherein the medical device comprises an endoscopic device.

[0198] An 18thembodiment is any combination of the above embodiments, wherein the medical device comprises an endoscope.

[0199] In another aspect, a first embodiment is a cleaning system for a medical device, the system comprising: a wipe configured for removing matter from an exterior surface of the medical device; and a cleaning element having an elongate member configured for advancement through a lumen of the medical device and at least one cleaning member coupled to a portion of the elongate member.

[0200] A second embodiment is the first embodiment, wherein the wipe comprises a cloth.

[0201] A third embodiment is any combination of the above embodiments, wherein the wipe comprises a sterile lint-free cloth.International Patent Application Attorney Docket No.: Gl 098-PCT

[0202] A 4thembodiment is any combination of the above embodiments, wherein the wipe comprises a material selected from the group consisting of polyester, microfiber and nonwoven material.

[0203] A 5thembodiment is any combination of the above embodiments, wherein the wipe comprises one or more components selected from the group consisting of isopropyl alcohol, water, deionized water, bleach, peroxide, sodium hypochlorite, sodium chloride, sodium carbonate and sodium hydroxide.

[0204] A 6thembodiment is any combination of the above embodiments, wherein the cleaning element 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.

[0205] A 7thembodiment is any combination of the above embodiments, further comprising a power source coupled to the cleaning element and configured to advance the cleaning element through the lumen of the medical device.

[0206] An 8thembodiment is any combination of the above embodiments, further comprising a motor coupled to the power source and the cleaning element.

[0207] A 9thembodiment is any combination of the above embodiments, further comprising a fluid delivery device configured to deliver a fluid through a lumen of the medical device.

[0208] A 10thembodiment is any combination of the above embodiments, wherein the medical device comprises an endoscopic device.

[0209] An 11thembodiment is any combination of the above embodiments, wherein the medical device comprises an endoscope.

[0210] In another aspect, a first embodiment is an automated cleaning system for an endoscopic device, the system comprising: a wipe configured for removing matter from an exterior surface of the medical device; a housing comprising a basin for receiving the endoscopicInternational Patent Application Attorney Docket No.: Gl 098-PCT device; a connector for coupling a tube to a lumen of the endoscopic device; a source of fluid; and a power source for delivering the fluid through the tube and the lumen of the endoscopic device.

[0211] A second embodiment is the first embodiment, wherein the wipe comprises a cloth.

[0212] A third embodiment is any combination of the above embodiments, wherein the wipe comprises a sterile lint-free cloth.

[0213] A 4thembodiment is any combination of the above embodiments, wherein the wipe comprises a material selected from the group consisting of polyester, microfiber and nonwoven material.

[0214] A 5thembodiment is any combination of the above embodiments, wherein the wipe comprises one or more components selected from the group consisting of isopropyl alcohol, water, deionized water, bleach, peroxide, sodium hypochlorite, sodium chloride, sodium carbonate and sodium hydroxide.

[0215] A 6thembodiment is any combination of the above embodiments, further comprising a cleaning device comprising an elongate member configured for advancement through the lumen of the endoscopic device and at least one cleaning member coupled to a portion of the elongate member.

[0216] A 7thembodiment 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.

Claims

International Patent Application Attorney Docket No.: Gl 098-PCTWhat is claimed is:

1. A drying system for a medical device, the system comprising: a wipe configured for removing matter from an exterior surface of the medical device; a pump having an outlet and configured to drive air through the outlet; and a tubing having a first end for coupling to the outlet and a second end configured for delivering a sufficient amount of air to dry the exterior surface of the medical device.

2. The drying system of claim 1, wherein the wipe comprises a cloth.

3. The drying system of claim 1, wherein the wipe comprises a sterile lint-free cloth.

4. The drying system of claim 1, wherein the wipe comprises a material selected from the group consisting of polyester, microfiber and nonwoven material.

5. The drying system of claim 1, wherein the wipe comprises one or more components selected from the group consisting of isopropyl alcohol, water, deionized water, bleach, peroxide, sodium hypocholorite, sodium chloride, sodium carbonate and sodium hydroxide.

6. The drying system of claim 1, further comprising a housing, wherein the pump is disposed within the housing.

7. The drying system of claim 1, wherein the pump is configured to drive the air in pulses.

8. The drying system of claim 7, wherein the pulses have a frequency of about 10 Hz to about 120 Hz.International Patent Application Attorney Docket No.: Gl 098-PCT9. The drying system of claim 8, wherein the frequency is about 60 Hz.

10. The drying system of claim 1, further comprising 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.

11. The drying system of claim 1, further comprising a drying element having an elongate member configured for advancement through a lumen of the medical device and at least one drying member coupled to a portion of the elongate member.

12. The drying system of claim 11, wherein the drying element 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.

13. The drying system of claim 10, a power source coupled to the drying element and configured to advance the drying element through the lumen of the medical device.

14. The drying system of claim 13, further comprising a motor coupled to the power source and the cleaning device.

15. The drying system of claim 13, further comprising a fluid delivery device configured to deliver a fluid through the lumen of the medical device.

16. The system of claim 4, wherein the fluid delivery device comprises a pump for delivering the fluid under pressure.

17. The system of claim 1, wherein the medical device comprises an endoscopic device.International Patent Application Attorney Docket No.: Gl 098-PCT18. The system of claim 1, wherein the medical device comprises an endoscope.

19. A cleaning system for a medical device, the system comprising: a wipe configured for removing matter from an exterior surface of the medical device; and a cleaning element having an elongate member configured for advancement through a lumen of the medical device and at least one cleaning member coupled to a portion of the elongate member.

20. The cleaning system of claim 19, wherein the wipe comprises a cloth.

21. The cleaning system of claim 19, wherein the wipe comprises a sterile lint- free cloth.

22. The cleaning system of claim 19, wherein the wipe comprises a material selected from the group consisting of polyester, microfiber and nonwoven material.

23. The cleaning system of claim 19, wherein the wipe comprises one or more components selected from the group consisting of isopropyl alcohol, water, deionized water, bleach, peroxide, sodium hypocholorite, sodium chloride, sodium carbonate and sodium hydroxide.

24. The cleaning system of claim 19, wherein the cleaning element 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.

25. The cleaning system of claim 19, further comprising a power source coupled to the cleaning element and configured to advance the cleaning element through the lumen of the medical device.International Patent Application Attorney Docket No.: Gl 098-PCT26. The cleaning system of claim 25, further comprising a motor coupled to the power source and the cleaning element.

27. The cleaning system of claim 19, further comprising a fluid delivery device configured to deliver a fluid through a lumen of the medical device.

28. The cleaning system of claim 19, wherein the medical device comprises an endoscopic device.

29. The cleaning system of claim 19, wherein the medical device comprises an endoscope.

30. An automated cleaning system for an endoscopic device, the system comprising: a wipe configured for removing matter from an exterior surface of the medical device; a housing comprising a basin for receiving the endoscopic device; a connector for coupling a tube to a lumen of the endoscopic device; a source of fluid; and a power source for delivering the fluid through the tube and the lumen of the endoscopic device.

31. The cleaning system of claim 30, wherein the wipe comprises a cloth.

32. The cleaning system of claim 30, wherein the wipe comprises a sterile lint- free cloth.

33. The cleaning system of claim 30, wherein the wipe comprises a material selected from the group consisting of polyester, microfiber and nonwoven material.International Patent Application Attorney Docket No.: Gl 098-PCT34. The cleaning system of claim 30, wherein the wipe comprises one or more components selected from the group consisting of isopropyl alcohol, water, deionized water, bleach, peroxide, sodium hypocholorite, sodium chloride, sodium carbonate and sodium hydroxide.

35. The cleaning system of claim 30, further comprising a cleaning device comprising an elongate member configured for advancement through the lumen of the endoscopic device and at least one cleaning member coupled to a portion of the elongate member.

36. The system of claim 35, wherein the power source is coupled to the cleaning device and configured to advance the cleaning member through the lumen of the endoscopic instrument.

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