System and method for drying and / or cleaning a device

Abstract

Devices and methods are provided for cleaning and / or drying devices, such as drinking straws for beverage containers, medical devices, endoscopic instruments, etc. A drying device for use with an endoscopic instrument includes an elongate member configured for advancement through an internal lumen within the endoscopic instrument, and a drying member removably coupled to a portion of the elongate member. The drying element includes a variable pressure region shaped and configured to increase hydrodynamic fluid friction and fluid pressure applied to the wall of the interior lumen of the endoscope to more effectively remove all moisture and fluid from the interior surface of the endoscopic instrument.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. patent application No. 17 / 739,146, filed on May 8, 2022, which is a continuation-in-part of U.S. patent application No. 17 / 509,304, filed on October 25, 2021, which in turn claims the benefit of U.S. patent application No. 63 / 105,072, filed on October 23, 2020, the entire disclosure of which is incorporated herein by reference for all purposes. Background Art

[0003] Endoscopes are used and reprocessed many times every day to provide highly advanced optical performance, consistent real-time imaging transmission, predictable scope handling, and other features important to the successful diagnosis and treatment of clinical conditions. This also occurs in non-medical applications involving inspection, cleaning, and repair of remote locations utilizing non-medical endoscopes. This includes, by way of example, but is not limited to, inspection and repair of hydraulic lines, oil field pipelines, refinery lines and lumens, sewer and pipeline lines, internal areas of internal combustion engines, and other non-medical applications involving remote visualization of areas that benefit from remote access and assessment.

[0004] Endoscopes are high-tech instruments that typically have advanced, expensive optical chips at the distal end of the scope to facilitate excellent visualization. These image signals are collected on the chip and then communicated through high-definition image transmission technology involving improved software and imaging processing hardware that processes the optical signals. These signals are then converted and projected by software and processors at many frames per second to an imaging screen, console, or other device that transmits the image to the user remotely from the optical chip.

[0005] The superior imaging capabilities of endoscopes have enabled many advances in both medical and non-medical fields. This is largely due to the combination of excellent optical performance and scope handling combined with the reusable nature of nearly all endoscopes. Due to the ability to clean, disinfect (if applicable) and reuse endoscopes with their advanced optical capabilities, this powerful combination allows advanced, high-quality optical components to become available at a reasonable cost per use. The ability to reuse these scopes effectively amortizes the high cost of the capabilities of the endoscopes across multiple procedures / uses, thereby enabling reasonable, low-cost access to advanced technologies for multiple beneficial uses around the world. Endoscopes with these advanced optical capabilities are too expensive to use once and discard. In addition, the environmental impact of discarding advanced electronics that facilitate endoscope capabilities is considerable, unwarranted and unsafe for the environment. Reusable scopes provide a way to make peak optical capabilities available for a variety of procedures, where otherwise people would not be able to afford the cost of using such technology.

[0006] Even with the considerable advances and capabilities provided by reusable endoscopes, recent concerns have arisen regarding one's ability to consistently and predictably clean and thereby remove all dirt and biological matter that contaminates endoscopes during use. Successful cleaning is a critical step in supporting 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 for the next use, as residual matter can accumulate and adversely affect scope performance. This applies to both non-robotic scopes and scopes used in conjunction with or otherwise with robotics to view, navigate, and treat (as applicable) using remote visualization.

[0007] With respect to these scopes, multiple contamination-related reprocessing issues have been noted that have resulted in potential patient infection and / or scope performance issues. These issues include issues with the cleanliness of the reusable valves used to facilitate aspiration and air / water expression, the presence of residual material that cannot be consistently removed from the complex distal tips of some scopes (particularly duodenoscopes and ultrasound endoscopes), and concerns regarding successful cleaning of the long biopsy / working channels in some scopes that are important for passing instruments to the distal tip of the scope.

[0008] Almost all of these issues can be addressed by using new relatively low-cost technologies and practices that were created in response to these concerns, that can be applied in the context of current workflow and procedural economics, and that are environmentally friendly, especially when compared to single-use scope alternatives. These relatively low-cost technologies and practices include using single-use disposable tubing and disposable valves instead of reusable tubing and valves, using sterile, single-use endoscope 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, using forced air drying, improving compliance with reprocessing pathways, and implementing post-procedural cultures and monitoring to address other areas of concern.

[0009] Despite all these advances, an area that remains to be addressed is the cleaning of the internal lumen of the endoscope. During medical procedures, the internal biopsy and aspiration channels become heavily contaminated with bacteria, biological matter, and debris by passing multiple instruments through the biopsy channels, and by activating suction to remove mucus, debris, and other materials that can obscure the physician's visual inspection during the procedure. All of these activities benefit the patient by providing care in a minimally invasive manner through the scope, but while these beneficial activities are taking place, the scope experiences severe contamination of these channels, which must then be effectively cleaned to return the scope to service for the next patient (or non-medical use) without exposing the next patient (or non-medical use) to the risk of infection associated with the scope (or a poorly performing, unclean non-medical scope). It is well known that in the event of unsuccessful cleaning, the endoscope cannot be successfully disinfected or sterilized. Unremoved biological matter and debris act as a barrier to pathogens, protecting the pathogens from being killed by the disinfectants and sterilants used to reprocess the scope. Additionally, unremoved biological matter and pathogens create opportunities for organisms to attach to surfaces within the scope, replicate, and form biofilms, which makes removal of these organisms particularly difficult, and this in turn creates the risk of multi-drug resistant infections spreading through the scope. Biofilms can replicate, detach, and then attach to new locations and repeat the process, while also recruiting other organisms into the biofilm during this process, creating additional multi-drug resistant organisms (MDROs) that cannot be effectively treated with antibiotics. MDRO infections are extremely dangerous and have resulted in multiple deaths worldwide from contaminated endoscopes that have not been successfully reprocessed.

[0010] The importance of successful cleaning has become even more apparent during the current Covid-19 pandemic. There is now ample evidence that Covid-19 infection begins in the lungs but rapidly migrates to the gastrointestinal tract, where the virus replicates in these organs before symptoms are detectable. A large number of endoscopic procedures involve the use of endoscopes, including, by way of example but not limitation, the examination and treatment of lung disease (e.g., bronchoscopy using a specialized endoscope called a bronchoscope), as well as the diagnosis and treatment of disease in the gastrointestinal tract (e.g., using gastroscopes, duodenoscopes, ultrasound endoscopes, and colonoscopes), raising the possibility that the Covid-19 virus could become encapsulated in a biofilm as a result of incomplete endoscope cleaning and subsequently develop into a resistant strain of Covid-19 that could be transmitted to subsequent patients. Given all of these concerns, new innovations are needed to significantly improve the effectiveness and predictability of successful cleaning of the lumen of an endoscope.

[0011] Current Cleaning Practices and Technologies

[0012] Current endoscope channel cleaning practices utilize certain cleaning techniques that can increase variability and even have a potential adverse effect on the success of cleaning endoscope channels. The most commonly used cleaning approach includes inserting a nylon silk bristle brush at the end of a long push / pull element into the proximal end of the biopsy channel of an endoscope. The silk brush is inserted into the biopsy port at the proximal end of the scope and is advanced downward along the biopsy channel to the distal end of the scope and is also repeated in other internal channels. This action should be performed when the scope is immersed in a cleaning fluid, with the purpose that after the scope is immersed in the cleaning fluid, the mechanical action of the silk bristles can remove biological matter and debris.

[0013] With this activity, after the wire bristle brush is immersed at the distal end of the biopsy channel, the person performing the cleaning should inspect the brush for any visible signs of debris, and if any debris is found, repeat this activity until no visible debris is found on the brush. The goal with this series of actions is to remove all visible debris and biological matter from the interior channel of the scope through the mechanical action of the brush. Brushing is performed after briefly immersing the scope in the cleaning fluid in order to loosen contaminants before passing through the brush.

[0014] Limitations of current approaches

[0015] The current approach to cleaning the endoscope channels has a number of significant limitations that increase the variability of cleaning results and have an overall adverse effect on the success of cleaning the endoscope channels. The first problem is that the current cleaning approach involves advancing a cleaning brush from the proximal end of the scope at the opening of the biopsy channel, moving down the channel to the distal end of the scope, where the instrument exits the scope from the patient. This approach means that any biological matter, 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 is the area associated with the majority of scope-related infections and deaths. In essence, the cleaning brush acts as a tool that not only partially removes debris from the channel, but also scoops or pushes contaminants out of the biopsy channel into the most difficult to clean areas 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 respect to the direction in which the cleaning brush passes through the biopsy channel and the aspiration channel (i.e., from the distal end through the proximal end and out of the biopsy channel). This current approach to using the brush occurs in certain complex scopes such as duodenoscopes, but due to limitations of current technology, including, by way of example and not limitation, exhibits the problem that the complex distal end of the scope causes the wire bristle brush to become stuck at the distal end and therefore cannot be advanced therefrom to clean the biopsy / working channel of the scope.

[0016] In addition to this limitation, the cleaning brush itself also has many significant limitations that hinder the success of consistent and repeatable scope reprocessing. Pictures of the inside of the scope biopsy channel after cleaning with a nylon bristle brush show that the bristles deflect when passing through the channel, leaving streaks along the inside of the channel instead of a clean and consistent cleaning effect. These channels may be highly contaminated with debris, biological matter and bacteria after repeated passes of treatment instruments during surgery and due to suction being activated during surgery to remove debris, mucus and other biological matter. Using a brush that deflects and causes streaks means that channel cleaning is incomplete and varies greatly. In addition, attempts to offset this limitation by repeatedly sweeping over with a nylon bristle brush recommended by the scope manufacturer do not overcome the problem and cannot produce a predictable and completely clean channel. Instead, the combination of repeated sweeps with a bristle brush causes surface damage to the internal endoscope channel because the bristles will produce scratches and breaks due to the effect of multiple wire passes. These scratches and breaks allow bacteria and biological matter to penetrate and remain in these new spaces, even if multiple brushes are passed over to clean the scope after the next use, limiting the consistency of cleaning results, thereby inhibiting disinfectants and sterilizers from successfully disinfecting and sterilizing the scope to safely restore it for the next use. All biological matter and debris must be successfully removed in order to successfully disinfect and reprocess the scope. The biological matter and debris left behind acts as a barrier to pathogens that may be present in these passageways, including bacteria naturally occurring in the patient's body, preventing successful treatment with disinfectants and sterilizers that kill the pathogens and make the scope safe for reuse on the next patient.

[0017] The assumption associated with this situation is that the person cleaning the scope will perform repeated wire bristle brushing passes. The scope manufacturer's instructions for use instruct the person cleaning the scope to make wire bristle brushing passes until there is no visible debris, which does not definitively prove that brushing passes result in successful cleaning, given the deflected bristles. Additionally, it is unclear whether all personnel involved in cleaning with wire bristle brushes always perform repeated brushing passes (plus visual testing is not entirely accurate). A device that can effectively and in a single pass clean the biopsy channel would be a significant way to address these issues.

[0018] Additional problems relate to instrument damage to the biopsy channel caused by incorrect passage of the instrument. The biopsy channel is typically made of PTFE or other polymeric materials. It is designed to allow predictable passage of the instrument, and typically has a low friction coefficient to support the passage of the instrument. The channel is compatible with a wider range of instruments, and the diameter of the instrument passed is significantly smaller than the diameter of the endoscopic biopsy / working channel, providing space for the instrument to be safely advanced through the channel. That is, sometimes the instrument is used improperly, such as attempting to open the biopsy forceps in the biopsy channel, or attempting to withdraw the biopsy forceps from the channel when the biopsy forceps are not properly closed. When this happens, scratches, dents or breaks will appear in the biopsy channel, which in turn increases the difficulty of successfully and predictably removing biological matter and debris when cleaning the biopsy channel. There is no evidence that silk bristle brushes can remove debris at the biopsy channel injury in a predictable and consistent manner. Recently published data from a national survey indicate that in two complex specialty endoscopes: duodenoscopes and ultrasound endoscopes, cleaning of the biopsy channel using current methods fails to remove biological matter and debris up to 15% of the time.

[0019] An alternative technology to nylon bristle brushes is a pull-through brush cleaner, such as the PullThru TM Cleaning Brush. The pull-through brush cleaner is designed with five cylindrical fins that are arranged very close to each other, with two of the fins grouped together, followed by a larger space, and then three additional fins grouped together. The fins are a flexible polymer overmolded over a harder strip of material and are used to advance the cleaner along the scope biopsy channel from the proximal end to the distal end of the scope while the scope is immersed in a cleaning fluid. The space between each set of fins is uniform, and the polymer between the fins is a thin, uniform thickness that is overmolded to adhere to the cylindrical monofilament. The benefit of the pull-through cleaner is less trauma to the biopsy channel wall compared to the wire brush cleaner. There is also some evidence that the pull-through cleaner is more effective in removing biological material from a contaminated biopsy channel.

[0020] However, there are several disadvantages to pull-through cleaning brushes. Similar to wire bristle brushes, pull-through cleaning brushes are designed to pull debris from the proximal end of the biopsy channel to the high-risk, difficult-to-clean distal end of the scope as it attempts to clean the biopsy channel of the scope, increasing potential contamination of the distal end. An additional limitation of these devices is that the cylindrical fins are significantly too large relative to the diameter of the biopsy channel, resulting in significant deflection at the ends of the fins, which produces a buckling effect, resulting in a gap between the fins and the biopsy channel. This gap or lack of consistent wall conformity may mean that not all potential contaminants are addressed when the pull-through brush moves through the biopsy channel. In addition, the gap means that changes in the wall surface of the biopsy channel (such as changes caused by scratches or breaks due to the instrument channel) are unlikely to be addressed by the pull-through brush as it moves through the biopsy channel. When the fins pass over damage to the channel wall, the fins cannot impact scratches and breaks.

[0021] An additional limitation common to all techniques for cleaning the interior lumen of endoscopes is the lack of synergy and complementary elements between the two techniques used for the cleaning steps. All reusable endoscope manufacturers require that the endoscope be placed in a fluid formulated to aid in the removal of biological matter and debris as the first step of the cleaning process, followed by a second step of brushing the interior channels while the scope is immersed in the cleaning fluid. Cleaning fluids come in a variety of formulations, but the most commonly used are either enzymatic cleaners or pH-neutral non-enzymatic cleaners. Cleaning agents are intended to loosen the adherence of biological matter and bacteria to the walls of the channels, but this is not effective by itself, and even with brushing, there is evidence that not all biological matter is consistently removed.

[0022] One of the significant limitations of this current approach is that the cleaning fluid and brushing application are separate technologies used together (i.e., the scope is immersed in the cleaning fluid while brushing of the channel occurs), but these technologies are not designed in a way that the technologies actively complement and enhance the effectiveness of each other. New innovations are needed to address the significant limitations of current brushing technologies and can actively complement and work in conjunction with the cleaning fluid used in this important cleaning step in reusable endoscopes. New innovations are needed to address these critical limitations and ensure predictable and consistent cleaning of the biopsy and aspiration channels of reusable endoscopes, as well as other lumens (if applicable).

[0023] Current Drying Practices and Technologies

[0024] Another significant unmet need for these instruments and this process is the downstream issues associated with drying the instruments after the cleaning and / or disinfection or sterilization process is complete. Most, if not all, disinfection or sterilization approaches involve some element of liquid or gas delivery of the disinfectant or sterilant followed by rinsing with an agent such as water or sterile water in most protocols, or evaporation of the agent in very limited selected cases.

[0025] In all of these processes, the critical final step after disinfection or sterilization is the drying of the instrument. For the external surfaces of medical devices, this aspect of the process is quite straightforward, but for recessed areas, and especially relatively narrow and sometimes long channels, the drying of these areas is difficult, time-consuming, and unpredictable or inconsistent. Failure to effectively dry will offset the benefits of the entire reprocessing approach (including disinfection and / or sterilization steps). This is because wet surfaces promote the proliferation of pathogens and biofilms. If the instrument is dry, pathogens and biofilms cannot grow. Hydration is a core element in the growth of pathogens and biofilms that cause infections, including nosocomial infections, drug-resistant infections, and other deadly infections. For non-medical uses, residual hydration promotes the growth of biofilms and pathogens, which can affect device performance and even ultimately expose users to one or more pathogens.

[0026] Current drying approaches employ a variety of inconsistent and variable methods that do not provide consistent assurance of moisture removal within these channels and recessed areas and thus drying of the remote and / or recessed areas. Unsuccessful attempts have been made to hang the device vertically with the wet channels positioned so that gravity causes the water within the channels to eventually flow down and evaporate. Evidence that the channels will not dry consistently and completely even after several days in this position has proven this approach to be faulty.

[0027] Attempts to overcome these problems have included flushing the channels with alcohol, on the assumption that this would speed drying and act as an additional bacteriostatic agent (even though the device in the medical application has already been disinfected or sterilized at this point). Data show that this does not significantly speed drying time or drying efficiency, and may even prolong the drying process in some cases. Additionally, there is concern that the use of alcohol may actually immobilize certain otherwise inert or harmless bacteria and pathogens in the channels, which in turn could be passed on to the patient or user.

[0028] Other approaches involve using air drying approaches, but air drying approaches are inherently difficult, time-consuming and variable due to the need to dry recessed and sometimes long and thin channels. Some of these channels are four to six feet long, and only a few millimeters or less in diameter. Attempts to dry include aiming compressed air at or into the channel, or hanging the instrument in a cabinet with circulating air, which uses a motorized fan to blow air into a small space to improve drying. Some of these approaches filter the air blown into a small area (such as an endoscope channel) by a motorized fan through a duct, and are labeled "forced air drying". Even these more proactive and targeted approaches have variable results, which are at least in part due to the distance that must be traveled due to the air drying channel, the variable diameter of the channel (which affects the air speed), and the surface tension of water (which may be greater than the force of the air at different points, hindering the effective and timely removal of water). In addition, the small space can be basically closed or help to maintain and promote a humid environment to inhibit evaporation. Challenges in addition to even these significant difficulties include endoscopes and other instruments having tortuous internal channels and lumens where one or more channels converge to create more varied surfaces, such as Y-junctions and connectors where water may pool, and areas near and / or outside of valves that interact with the channels.

[0029] Therefore, it is desirable to provide improved systems and methods for removing biological matter from endoscopic instruments such as endoscopes and other instruments having remote channels and lumens after cleaning and then drying these endoscopes so that the channels and lumens can be effectively sterilized or disinfected. In particular, it is desirable to provide devices that can effectively clean and / or dry all internal surfaces of endoscopic technology, including breaks, Y-joints, and scratches or other irregularities, without further damaging these surfaces. Summary of the invention

[0030] Provided are devices and methods for removing biological matter, tissue or other debris from endoscopic instruments such as endoscopes, particularly internal lumens or other spaces within endoscopic instruments. Also provided are devices and methods for drying the internal lumens of these endoscopic instruments after cleaning, and for testing to confirm the success of cleaning and drying. The methods and devices disclosed herein can be used with various different reusable or disposable endoscopic instruments and devices including internal lumens or other internal spaces, or can be incorporated therein, such as endoscopes, trocars, cannulas, dilation devices, Foley catheters and other indwelling catheters, guidewires, central venous catheters, bipolar or monopolar electrosurgical or ultrasonic devices, arterial lines, drainage catheters, peripherally inserted central catheters, endotracheal tubes, feeding tubes, ventilators, dialysis machines, continuous positive airway pressure (CPAP) machines, perfusion machines, infusion pumps, respirators, robotic and non-robotic surgical devices, and other devices for indwelling, penetrating and / or navigating in vivo. Of course, the size of the cleaning and drying devices disclosed herein will be adjusted according to the size of the specific instrument or device.

[0031] For example, the methods and devices disclosed herein can be used to clean and / or dry components of a CPAP machine, such as hoses, tubes, headgear, filters, humidifiers, masks, and / or flow drivers, such as air entrainment valves, flow-dependent resistor devices, air sources providing pneumatic power, venturi flow drivers, and the like.

[0032] The methods and devices disclosed herein can also be used to clean and / or dry the interior surfaces of drinking containers and components of drinking containers, such as drinking straws, beverage containers, water containers, bottles, thermoses, kettles, pitchers, carafes, baby bottles, water bottles, and insulated beverage containers and drinking straws for any of these containers. For example, the devices herein can be used to clean and / or dry the interior surfaces of drinking straws in water bottles and / or the actual water bottles. In some cases, the devices disclosed herein are incorporated into these beverage containers as a kit.

[0033] The disclosed innovations address multiple limitations of current approaches for cleaning and / or drying lumens or channels, and provide new and important capabilities to improve cleaning and drying performance. In some embodiments, the devices disclosed herein overcome significant deficiencies of current channel cleaning approaches for endoscopes, in which brushes and cleaning fluids are not designed to work together and complement the respective capabilities of each technology. These innovations not only address current issues regarding brushes, but also complement and enhance the effectiveness of cleaning fluids used in the channels of endoscopes. In addition, certain embodiments provide the following advantages: the lumen of endoscopic instruments can be cleaned without creating defects in the surface of the internal lumen. This extends the service life of the instrument and allows the instrument to be cleaned multiple times without providing additional areas for biological matter, pathogens or other debris to reside. In certain embodiments, these innovations provide devices that can quickly and continuously dry the internal lumen or channels of endoscopic instruments.

[0034] In one embodiment, a drying device for use with an endoscopic instrument includes: an elongated member configured to be advanced through a lumen within the endoscopic instrument; and a drying element coupled to at least a portion of the elongated member. The drying element includes certain portions having an outer diameter equal to or greater than an outer diameter of the elongated member.

[0035] In an embodiment, the elongated member includes an attachable push-pull element, such as a navigation element, which can be advanced from the proximal end of the internal lumen of the endoscopic instrument (such as the biopsy channel on the endoscope) to the distal end of the biopsy channel so as to be withdrawn from the biopsy channel and connected to the drying element. In some embodiments, the drying element is removably attached to the distal end portion of the propulsion or navigation element. In other embodiments, the drying element is permanently attached to the navigation element. These embodiments allow the drying element to be translated from the distal end of the viewing scope lumen to its proximal end, or vice versa.

[0036] In one embodiment, the drying component includes: a distal end portion and a proximal end portion having a diameter substantially equal to or greater than the inner diameter of the lumen; and a variable pressure center portion between the distal end portion and the proximal end portion. Alternatively, the proximal end portion and the distal end portion may have a diameter significantly smaller than the inner diameter of the lumen. The variable pressure center portion is shaped to produce a pressure gradient along the center portion from the distal end portion to the proximal end portion. When the drying component is advanced through the lumen, the pressure gradient causes an increase in the relative velocity between the drying component and any air or fluid in the lumen. The increase in the velocity of the air fluid will increase the shear stress between the air or fluid and the lumen wall, thereby generating a greater force to dry the wall.

[0037] In certain embodiments, the drying device is sterilized or disinfected so that the sterilized and / or disinfected device channel is not damaged by the drying process. Instead, when the drying device passes through the sterilized or disinfected device channel, water and moisture are removed without changing or contaminating the sterilized or disinfected state of the device through the channel.

[0038] In an embodiment, the proximal end portion and the distal end portion of the drying component produce consistent circumferential contact with the inner wall of an endoscope channel (such as a biopsy channel or a suction channel). In certain embodiments, these channel contact elements preferably have a substantially circumferential, cylindrical or conical shape, wherein at least a portion of the element has a diameter that is approximately equal to or slightly larger than the diameter of the internal lumen. In an exemplary embodiment, the diameter of the proximal end portion and the distal end portion is about 1 to about 1.5 times the diameter of the internal lumen, preferably about 1 to about 1.25 times the diameter. This avoids deflection of the proximal end portion and the distal end portion, thereby reducing buckling and the generation of gaps between the drying element and the inner wall of the lumen.

[0039] The variable pressure center section is designed to create a variable pressure between the two circumferential elements and the wall of the cleaned channel. Thus, as the drying component is advanced within the channel and the scope and its channel, the variable pressure design between the two circumferential elements creates an eddy flow, a venturi effect, an inverted or reverse venturi effect, or other variable pressure between the drying element and the wall of the endoscope channel as the drying element passes through the lumen.

[0040] In some embodiments, the central section of the dry component includes a contraction section connected to the proximal end portion, a diffusion section connected to the distal end portion, and a throat section connecting the diffusion section and the contraction section. The throat section has a diameter that is smaller than the diameter of the proximal end portion and the distal end portion and larger than the diameter of the diffusion section and the contraction section.

[0041] The variable pressure zone between the two cylindrical elements may include an inverted partial venturi shape, a parabolic shape, a variable slope shape, or such other shapes that produce variable pressure or eddy currents between the two cylinders and the wall of the dry passage, thereby increasing the force relative to the passage wall when the dry component is advanced. In an exemplary embodiment, the throat section is substantially cylindrical. The diameter of the contraction section preferably increases from the proximal end portion to the throat section, and the diameter of the diffusion section preferably decreases from the throat section to the distal end portion, thereby producing eddy currents, venturi effects, inverted or reverse venturi effects, or other variable pressures between the distal end portion and the proximal end portion of the dry element.

[0042] The angle of the slope of the contraction section can vary depending on the diameter of the dry channel and other factors, and should be sufficient to support the variable pressure flow between the cylinders when the dry element is advanced. In some embodiments, the contraction section defines an angle of about 4 degrees to about 85 degrees, preferably about 15 degrees to about 30 degrees with the proximal end portion. Similarly, the diffusion section defines an angle of about 4 degrees to about 85 degrees, preferably about 15 degrees to about 30 degrees with the distal end portion. In other embodiments, the contraction section may have more than one slope, a curved shape, a variable shape, or other such shapes that help change the pressure between the two cylindrical elements.

[0043] Likewise, the angles between the contraction and divergence sections and the throat section may vary depending on the diameter of the drying passage and other factors, and should be sufficient to support variable pressures between the cylinders as the drying element advances. In certain embodiments, the 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.

[0044] The length and diameter of each segment of the variable pressure zone are preferably selected to optimize vortex, venturi effect, inverted or reverse venturi effect or other variable pressure, and will vary based on the diameter of the internal lumen and other factors. For example, in a lumen having a diameter of about 4.2 mm, the length of the throat segment may be about 2 mm to 10 mm, preferably about 3 mm to 5 mm, and more preferably about 4 mm. The diameter of the throat segment will also depend on the diameter of the internal lumen and the diameters of the contraction and diffusion segments. In certain embodiments, the throat segment has a diameter that 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.

[0045] When the drying element is advanced through the lumen, the variable pressure zone of the drying element is configured to generate pressure relative to the inner wall of the lumen. In certain embodiments, the variable pressure zone is configured to generate a peak pressure of at least about 75 Pa in at least one region between the distal end portion and the proximal end portion of the drying element. The peak pressure is preferably at least 100 Pa and more preferably at least 125 Pa. In an exemplary embodiment, the peak pressure may be about 150 Pa. This direct pressure relative to the lumen wall is sufficient to completely remove all fluid and moisture from the interior surface of the lumen.

[0046] The variable pressure zone of the dry element is configured to generate a mean or average pressure of at least about 10 Pa, preferably about 20 Pa, and more preferably about 30 Pa across the distance between the proximal and distal end portions of the dry element. In an exemplary embodiment, the average pressure is about 36 Pa.

[0047] The variable pressure zone of the desiccant element is also configured to generate a peak shear stress of at least about 4 Pa, preferably at least about 5 Pa, and more preferably at least about 8 Pa in at least one region between the distal end portion and the proximal end portion of the desiccant element. The average shear stress across the distance between the proximal end portion and the distal end portion of the desiccant element is at least about 1 Pa, preferably about 2 Pa, and more preferably greater than 2.5 Pa. In an exemplary embodiment, the average shear stress is about 2.8 Pa.

[0048] In certain embodiments, the drying device / element includes more than one drying component. For example, in one such embodiment, the drying device includes 2-10 drying components, preferably 2-5 drying components. The drying components can be connected to each other to provide a series of such drying components separated along the navigation element or at various distances to improve the efficiency of the device. In these embodiments, for example, the proximal end portion of a drying component can be connected to the distal end portion of the next drying component along the series, or can be integrated with it. Each of the drying components includes: a distal end portion and a proximal end portion, which have a diameter substantially equal to or greater than the inner diameter of the inner cavity; and a central portion between the distal end portion and the proximal end portion. The central portion of each drying component is shaped to generate a pressure gradient from the distal end portion to the proximal end portion along the central portion. The variable pressure element in each drying component can be the same, or can be changed to produce an alternating pressure curve. A plurality of cylindrical elements with variable pressure elements between cylindrical elements can be more or less than five groups, depending on a given application.

[0049] In one embodiment, the drying element is removably coupled to the elongated navigation element so that the navigation element can be advanced from the proximal end of an endoscope lumen (such as a biopsy channel) through the lumen to its distal end. The navigation element can then be attached to the drying element so that the entire system can then be pulled back from the distal end of the endoscope through the lumen to its proximal end. The drying approach can also be used to dry other lumens in the scope, including the suction channel and the air / water channel (if applicable). In other cases, the device can be used to dry from the proximal end to the distal end of a channel or other endoscopic instrument to be cleaned.

[0050] In embodiments, the drying component or the elongated navigation component may include an element that centers the navigation element and the drying element as the device is pulled or pushed through the lumen around turns and navigates through corners and other complex areas, including the junctions of multiple lumens and internal channels in a scope or other instrument being cleaned. In embodiments, the centering element is smaller than the diameter of the lumen through which the device is advanced, but is of sufficient size to prevent the navigation element from being misaligned and biased to one side or the other of the lumen as it navigates, including when the cleaning element is pulled or pushed around curves, corners, and junctions of various lumens, including Y-shaped junctions.

[0051] In some embodiments, the centering element may include a series of shaped elements protruding from the elongated member or the navigation member. The series of shaped elements may, for example, include struts, spikes, or other protrusions extending radially outward from the elongated member and sized to substantially center the elongated member and / or drying / cleaning element within the interior passage of the endoscopic device.

[0052] The centering element can be any shape that keeps the device generally centered in the lumen and prevents this deflection, with a preferred embodiment being a cylindrical shape with a tapered distal end. When this misalignment occurs, which is a problem with existing brushes and pull-through devices, the brushes and other elements are pulled to one side of the lumen as the device is pulled around the curves, corners, and junctions of the lumen, with the result that contact with the lumen wall and the drying element (whether brush, pull-through device, or other device) is minimized, altered in an unfavorable manner, or lost, resulting in an adverse effect on the effectiveness of the drying pathway. By placing a centering element at the front or back of the device, or both, this problem is corrected, resulting in more consistent effective drying, especially around curves, corners, channel junctions, and other complex areas inside an endoscope or other endoscopic instrument or device.

[0053] In a preferred embodiment, the centering element is between 50 and 90 percent of the diameter of the clean lumen, with another preferred embodiment having a diameter or height between 70 and 85 percent of the diameter of the clean lumen. The centering element can be any shape that keeps the dry element centered as the dry element navigates through the channel. In embodiments, this includes cylindrical, conical, spherical, and the centering element can be placed at the distal region of the device, at the distal end and the proximal end, between the dry components, or at the proximal end (as the case may be) to help center the dry element, especially when it navigates around curves, across Y-joints, and other aspects of the lumen.

[0054] In certain embodiments, the drying device includes a programmable motor coupled to the elongated member and configured to translate the device through the lumen of the endoscopic instrument. Preferably, the programmable motor is configured to withdraw the elongated member through the lumen a specified distance within a specified duration. For example, the motor can be programmed to withdraw the elongated member at a specific speed that optimizes the increased speed generated by the variable pressure zone within the drying member, thereby ensuring that the interior lumen is fully dried without damaging the surface.

[0055] On the other hand, a kit for cleaning and drying an endoscopic instrument includes a drying device having a propulsion element configured to be advanced through an inner cavity in the endoscopic instrument, and at least one drying component coupled to a portion of the propulsion element. At least a portion of the drying component is shaped and configured to substantially maintain contact with a wall of the inner cavity when the propulsion element is advanced through the inner cavity. The kit also includes a cleaning device having an elongated component configured to be advanced through an inner cavity in the endoscopic instrument, and at least one cleaning component coupled to a portion of a second elongated component. The cleaning component includes a distal end portion and a proximal end portion and a central portion between the distal end portion and the proximal end portion, and wherein the central portion is shaped to generate a pressure gradient along the central portion from the distal end portion to the proximal end portion.

[0056] In one embodiment, the drying device is one of the above embodiments and includes a distal end portion and a proximal end portion and a central portion between the distal end portion and the proximal end portion, and wherein the central portion is formed to generate a pressure gradient along the central portion from the distal end portion to the proximal end portion.

[0057] The cleaning device may also include any of the combinations of elements described above relative to the drying device. The variable pressure center portion of the cleaning device is designed to generate variable pressure between two circumferential elements and the wall of the cleaned channel. Therefore, when the cleaning element is advanced in the channel and the sight glass and its channel are immersed in the cleaning fluid (according to the requirements of the sight glass manufacturer), when the cleaning element moves through the inner cavity, the variable pressure design between the two circumferential elements generates eddy currents, venturi effects, inverted or reverse venturi effects or other variable pressures between the cleaning element and the wall of the endoscope channel. As a result, when the cleaning fluid flows across the variable pressure region, this affects the fluid flow when the fluid flow is transferred from the high pressure region across the low pressure region and then returns to another high pressure region between the two cylindrical elements. This guides the cleaning fluid at the channel wall with increased speed and force, thereby removing more biological substances and other debris than conventional devices. In embodiments, this same approach is also applied to a drying device where air is directed by creating vortices, a venturi effect, an inverted or reverse venturi effect, or other variable pressure between a drying element and the walls of the channel as the device moves through the channel to remove fluid and moisture and dry the channel.

[0058] In certain embodiments, the drying device of the kit includes a propulsion element, which may be a filament, a wire, a tube, or other elements that can be advanced into an internal passage, including a long passage, a curved passage, or other passages that are inaccessible due to their recesses or being located inside. In an embodiment, once the element is pulled through the internal passage, the element can be grasped at the end, and then pulled through the passage as part of the drying process. It can also be advanced from the other end by pushing the propulsion element. The element may include a version that enables air to be advanced through the device and into the passage (including a removal position to reach the interior of the passage), and exceeds the typical effectiveness of forced air drying in the passage.

[0059] The drying component may include one or more substantially cylindrical components spaced apart from each other along the propulsion component. The cylindrical component is configured to maintain contact with the channel wall when the propulsion element advances through the channel to transfer and remove any moisture. The propulsion element may be advanced by being pushed, pulled, or by other means, including stirring back and forth, advancing, and withdrawing based on a pattern. The propulsion element may advance through the sight glass by combining an automated or mechanized approach or any other means that moves the channel drying element through the channel to transfer, absorb, and / or remove water at least in part by direct contact with the surface area to be dried.

[0060] The drying member may be a disk, fin, squeegee or other protrusion extending outwardly from the elongated member. In an embodiment, the drying member is shaped to produce consistent circumferential contact with the inner wall of an endoscope channel when the elongated member is advanced through the endoscope channel (such as a biopsy or suction channel).

[0061] In certain embodiments, the drying component preferably has a substantially annular, circumferential, cylindrical or conical shape, wherein at least a portion of the element has a diameter that is approximately equal to or slightly greater than the diameter of the internal lumen. In an exemplary embodiment, the diameter of the proximal end portion and the distal end portion is about 1 to about 1.5 times the diameter of the internal lumen, preferably about 1 to about 1.25 times the diameter. This avoids deflection of the proximal end portion and the distal end portion, thereby reducing buckling and the generation of gaps between the drying element and the inner wall of the lumen.

[0062] In certain embodiments, the elongated member of the drying device comprises a filament, a wire, a tube, a shaft or other element that can be advanced into an internal passage, including a long passage, a curved passage or other passage that is difficult to access because it is recessed or located inside. In an embodiment, once the element is pulled through the internal passage, the element can be grasped at the end and then pulled through the passage as part of the drying process. It can also be advanced from the other end by pushing the advancement element. The element may include a version that enables air to be advanced through the device and into the passage (including a removal position to reach the interior of the passage), and exceeds the typical effectiveness of forced air drying in the passage.

[0063] The drying component may include one or more substantially annular or cylindrical components spaced apart from each other along the elongated component. The cylindrical component is configured to maintain contact with the channel wall when the elongated element travels through the channel to transfer and remove any moisture. The elongated element may be advanced by being pushed, pulled or by other means, including stirring back and forth, advancing and withdrawing based on a pattern. The elongated element may be advanced through the sight glass by being incorporated into an automated or mechanized approach or any other means that moves the channel drying element through the channel to transfer, absorb and / or remove water at least partially by direct contact with the surface area to be dried.

[0064] In embodiments, the drying element of the present invention may be any shape or form that can transfer water and moisture by advancing and withdrawing, including scrapers, disks, fins, cylinders, a series of absorbent strips, venturis or inverted venturis, oblong and circular shapes, spheres or spherical drying elements. Fins, disks, scrapers or other annular components or other drying components may be at any angle to the channel wall that promotes and enhances drying, including vertical, angles between 1 and 89 degrees tilted backward, angles between 1 and 89 degrees tilted forward, or any other angles that promote drying. In embodiments, these angles should not be limited to this description and should vary based on what is most effective for drying a given channel drying application.

[0065] In an embodiment, the drying component may include a series of one or more cylindrical scrapers, which are designed to make wall contact with the inner wall of the channel to remove fluid and moisture from the channel. These cylindrical scrapers can be arranged in any manner to effectively remove liquid and moisture from the channel. Depending on the channel diameter, length, curve, junction with other channels and other factors, this includes groups of two and then three scrapers, or vice versa, or other configurations of scrapers, such as groups of one and then two scrapers, two and then four, three and three, four in a row, five in a row, or any other number and configuration of scrapers that effectively remove water and moisture.

[0066] In embodiments, some of these scrapers may have different heights to make the device more suitable for use with different sized channels. For example, the device may have a scraper with a diameter of 5 to 5.2 mm, followed by a smaller scraper with a diameter of between 2 and 2.2 mm, followed by another scraper with a diameter of 3.8 to 4 mm to create variable wall contact across various channel sizes. In embodiments, the height and arrangement of the scrapers are not limited to this specification, and these diameters, positions, scraper thicknesses, etc. should vary based on what is most effective for drying a given channel drying application.

[0067] The spacing between the scraper and any other elements (including the drying elements) can be any spacing that supports fast and predictable tunnel drying, including spacing of 1 mm, 1.25 mm, 1.5 mm, 2 mm, a close spacing of 1.25 mm followed by a 4 mm gap followed by a spacing of 1.25 to 1.5 mm, or other spacings that are closer or farther or more variable that optimize and support fast and predictable tunnel drying. In embodiments, the spacing, diameter, and arrangement and grouping of drying elements can vary based on tunnel size, tunnel material, the number of curves to navigate around, the number of junctions with other tunnels (if any), tunnel dryer material, and other factors specific to a given tunnel drying application.

[0068] The thickness of the scraper and fins is any thickness that facilitates channel drying and positioning the fins and scrapers for drying and, in some embodiments, cleaning. In embodiments, this includes scraper and fin thicknesses between 0.2 and 0.5 mm; other variations with thicknesses of 0.5 to 1.0 mm; other variations with tapered thicknesses, where the thickness at the base of the scraper or fin is greater and tapers closer to the channel wall to enhance element deflection and conformity of the element to the channel wall while providing support and some rigidity and flexibility around the propulsion element.

[0069] The annular components are spaced apart from each other along the elongated member. In some embodiments, the distance between each annular component is substantially equal. In other embodiments, the distance may vary between some or all of the annular components. For example, the device may include a first annular component, a second annular component, and a third annular component, wherein the first annular component and the second annular component are spaced apart from each other by a greater distance than the second annular component and the third annular component.

[0070] In one embodiment, the device comprises at least a first group of annular components and a second group of annular components, wherein each group has a plurality of annular components. The annular components within each group may be substantially equally spaced from each other, or their spacing may vary. The first group is spaced from the second group by a greater distance than the spacing within each group in the first group and the second group.

[0071] In another embodiment, the elongated member includes a rod member having a first end, a second end, and a loop coupled to the first end. The device may also include a swab member having a first end attached to the loop and a second end including a tail. The swab member may have a first end and a second end, wherein the first end is attached to the loop and the second end includes a tail, such as the tail of a kite, wherein the tail may be of any length. The swab member may include one or more materials that may be woven or twisted, wherein the tail end of the swab member includes an unwoven or untwisted end of one or more materials constituting the swab member. In addition, the swab member may include a foam material and / or a microfiber material.

[0072] Additionally, the rod component may include a continuous polymer rod, wherein the annular end of the rod component includes one thickness or diameter, and the straight end of the rod component includes two thicknesses or two diameters of the annular end of the rod. The two thicknesses or diameters of the polymer rod forming the straight end of the rod component may be melted or bonded together, laminated together, or coextruded.

[0073] In an embodiment, the drying device includes a centering element so that the drying element remains centered when they are advanced through the channel to dry. The centering element can prevent the drying element from losing contact with the wall of the channel being dried to enhance the drying effect. The centering element can be any shape that keeps the device substantially centered in the lumen and prevents the deflection, wherein a preferred embodiment is a cylindrical shape with a tapered distal end. When this misalignment (which is a problem with existing brushes and pull-through devices) occurs, as the device is pulled around the curves, corners and joints of the lumen, the brush and other elements are pulled to one side of the lumen, resulting in the contact with the lumen wall and the drying element (whether it is a brush, a pull-through device or other device) being minimized, changed or lost in an unfavorable manner, resulting in an adverse effect on the effectiveness of the drying approach. By placing a centering element in front of or behind the device or at both, this problem is corrected, resulting in more consistent effective drying of curves, corners, channel joints and other complex areas around the inner side of an endoscope or other endoscopic instrument or device.

[0074] In a preferred embodiment, the centering element is between 50 and 90 percent of the diameter of the clean inner lumen, with another preferred embodiment having a diameter or height between 70 and 85 percent of the diameter of the clean inner lumen.

[0075] In some embodiments, the centering element may include a series of shaped elements protruding from the elongated member or the navigation member. The series of shaped elements may, for example, include struts, spikes, or other protrusions extending radially outward from the elongated member and sized to substantially center the elongated member and / or drying / cleaning element within the interior passage of the endoscopic device.

[0076] In another aspect, a kit for cleaning and drying an endoscopic instrument includes a drying / cleaning device having an elongated member configured to be advanced through a lumen within an endoscopic instrument, and at least one cleaning / drying member coupled to a portion of a second elongated member. The cleaning / drying member includes a distal end portion and a proximal end portion and a central portion between the distal end portion and the proximal end portion, and wherein the central portion is shaped to generate a pressure gradient along the central portion from the distal end portion to the proximal end portion.

[0077] In this aspect, the drying / cleaning device is configured to both clean and dry the interior lumen while passing through the interior lumen. In embodiments, this version may be particularly suitable for cleaning and drying after the use of liquid chemical sterilants and disinfectants.

[0078] In a preferred embodiment, the present invention is configured for use with an endoscope. The propulsion element is a polymer filament, wire or tube. The material used for the propulsion element is any material suitable for the application, and in embodiments, it may be polypropylene, PET, nylon, PEEK, PTFE, ETFE, polyurethane, high density or low density polyethylene or other suitable polymer material. The propulsion element may also be a metal wire (including stainless steel, nitinol or other materials), or a combination of materials, including a polymer reinforced by a wire, or a wire covered with a polymer, or a combination thereof.

[0079] In one embodiment, the drying element is formed by injection molding, 3D printing or otherwise, or is otherwise formed or attached above the propulsion element or connected or glued to the propulsion element. The drying element is any durometer that helps dry the passage, but in a preferred embodiment, the hardness of the material is between 35 and 75 Shore hardness. In an embodiment, the drying element can be made of any elastomer or any elastic material, including pebax, polyurethane, santoprene, silicone, high-density or low-density polyethylene, EVA and other elastomeric materials. In an embodiment, the drying element can be a combination of multiple materials, including a combination of hard materials and soft materials with different elasticities.

[0080] In embodiments, versions of the drying portion of the present invention may include a water-absorbent material, such as a sponge, absorbent cloth, or other material that absorbs and retains moisture and water. The material may be attached to the propulsion element as a cylinder, as a single or various lengths of material strips, as overlapping materials, as a sphere, or as any other shape that helps remove water and moisture from the passage as the propulsion element passes through the passage. The absorbent material may be located at the end or beginning of the drying element, or interspersed between other drying elements, such as scrapers or fins.

[0081] In embodiments, the drying elements of the present invention may be any shape or form that can transfer water and moisture by advancement and withdrawal, including scrapers, cylinders, a series of absorbent strips, venturis or inverted venturis, elliptical and circular shapes, spheres or spherical drying elements.

[0082] The present invention may include coatings that help attract or repel water and aid navigation by changing friction levels. The present invention may have internal cavities that allow air to be blown through the present invention to deliver forced air deep into the channel close to or directly adjacent to the channel walls.

[0083] On the other hand, a method for drying one or more lumens in an endoscopic instrument includes advancing an elongated member having at least one drying member through the lumen in the endoscopic instrument and generating a pressure gradient along a central portion of the drying member. As the drying member is advanced through the lumen, the pressure gradient causes an increase in relative velocity between the drying member and any air or fluid in the lumen. The increased velocity of the fluid or air increases the shear stress between the fluid or air and the lumen wall, thereby generating a greater force to dry the wall.

[0084] In an embodiment, the central portion of the drying component includes a contraction section connected to the proximal end portion, a diffusion section connected to the distal end portion, and a throat section connected to the diffusion section and the contraction section, wherein the throat section has a diameter that is smaller than the diameters of the proximal end portion and the distal end portion and larger than the diameters of the diffusion section and the contraction section.

[0085] In an embodiment, the method further comprises centering the drying element within the lumen as the drying element is advanced through the lumen. The centering element is preferably smaller than the diameter of the lumen through which the device is advanced, but of sufficient size to prevent the navigation element from being misaligned and biased to one side or the other of the lumen as it is navigated, including as the drying element is pulled or pushed around various lumen curves, corners, and junctions (including Y-shaped junctions).

[0086] The method includes introducing a guide element through a first opening in a lumen of the instrument, and advancing an elongated drying device through a second opening in the lumen so that at least a portion of the elongated drying device engages the guide element. The guide element engages and couples with the drying device so that the drying device can be withdrawn toward the first opening of the lumen using the guide element.

[0087] In some embodiments, the endoscope lumen includes a first lumen and a second lumen coupled to each other at a joint, such as a Y-shaped joint between a biopsy channel and a suction channel in an endoscope. In these embodiments, the method further includes introducing a directing element through the first lumen through the joint into the second lumen, and advancing an elongated drying device through the second lumen so that the elongated drying device engages the directing element. The directing element can then be used to withdraw the drying device through the joint and through the first lumen. This ensures that the drying device dries the biopsy channel, rather than being deflected and continuing to pass through the Y-shaped joint further proximally into the suction channel.

[0088] In other embodiments, the endoscope lumen includes a turn or bend with a relatively small radius of curvature through which the drying element would otherwise be difficult to advance. In these embodiments, the guiding element is introduced through the lumen on one side of the turn and advanced therethrough. The drying device is advanced or retracted through the lumen on the other side of the turn until it engages the guiding element. The guiding element is then withdrawn to pull the drying device through the turn.

[0089] The guiding element may include a tubular sheath or similar device having a distal end portion configured to engage the end portion of the cleaning element. In some embodiments, the tubular sheath is removably coupled to the cleaning element. In other embodiments, the tubular sheath may have an inner diameter greater than the outer diameter of the proximal end portion of the elongated cleaning element, and may be further configured to deflect or otherwise guide the drying element through a junction or other tortuous region in the lumen.

[0090] In some embodiments, the end of the guide element is angled to further conform to the shape of the multi-channel internal joint within the scope. In other embodiments, the end of the navigation element may have a flange that is larger than the entry opening of the particular scope channel into which the navigation element is inserted, so that the navigation element cannot be fully advanced into the channel and causes difficulty in retraction. In alternative embodiments, the navigation element may not have a flange, but may have markings, including, for example, pad-printed lines or other lines, to mark the most recommended point for advancement of the navigation element into the scope or other channel.

[0091] In other embodiments, the cleaning / drying device may have one or more absorbent sponges placed in the front or end of the cleaning / drying device, or placed between one or more of the cylindrical elements to absorb biological substances and debris. The absorbent sponge may be a single chamber structure, or a plurality of sponges with different chamber structures, to provide the combination of scrubbing, absorption, promotion, diffusion or these attributes of cleaning fluid. The absorbent sponge may include any material that absorbs biological substances, fluid or other debris, such as polymer, foam, sponge, bamboo, hemp, microfiber, polyurethane, polyvinyl alcohol, etc. In one embodiment, the cleaning component includes a sponge-like material, such as cellulose, dry cellulose, natural cellulose and / or compressed cellulose. In an exemplary embodiment, the material includes a mixture of cellulose and compressed cellulose, which allows the sponge to expand when it is hydrated. Preferably, the material is selected so that the sponge has the internal surface that expands to the inner cavity at least, while in a preferred embodiment, keeps enough absorptivity to absorb the material or the volume of the fluid that is at least equal to the inner cavity segment volume it occupies.

[0092] In embodiments, the sponge is soft and atraumatic when immersed in a fluid, and expands to a size at least sufficient to remove debris from the channel being cleaned (and / or to remove water and fluid from the channel), and in preferred embodiments is larger than the channel being cleaned. The sponge can be any shape and size that conforms to and facilitates cleaning the channel of the sight glass, including, but not limited to, cylindrical shapes, spiral shapes, cones, triangles, squares, or any combination thereof, for example.

[0093] In embodiments, a cleaning component or a drying component may have more than one cylindrical element placed in close proximity to another (including one or more cylindrical or other shaped elements), with a spacing that does not produce an average variable pressure between the elements, followed by a cylindrical element or alternatively preceded by a cylindrical element with a spacing between the cylindrical element and the next cylindrical element that produces a variable pressure between the cleaning / drying component and the wall of the channel being cleaned. In embodiments, a series of cylindrical elements may be organized at various spacings to produce a variable pressure between the cylindrical elements, and at a certain spacing to produce a constant pressure between the cylindrical elements.

[0094] In other embodiments, device disclosed herein can be used for drying and / or cleaning indwelling device.In these embodiments, the device can also include sheath or similar structure, to cover cleaning and / or drying element and / or navigation element when translating through the lumen of apparatus, to avoid interfering with biological matter therein and the biofilm of any accumulation.The system can also include measuring device, such as mark on navigation element or separate elongated element, to confirm the positioning of device in the lumen of conduit.Once withdrawing sheath, the polymer forming cleaning and / or drying element can expand.Alternatively, electroresponsive polymer can be used for changing shape and expanding along with the application of energy, causing them to expand and contact the wall of conduit, or at least partially contact the wall of conduit.

[0095] The device may include a hydrophobic coating. In yet another embodiment, the device is superhydrophobic and / or oleophobic. In yet another embodiment, the device is anti-infective and hydrophobic. In yet another embodiment, the device is anti-infective and superhydrophobic. In yet another exemplary embodiment, an anti-inflammatory coating is incorporated into the device. In other embodiments, the anti-inflammatory coating may include a hydrophilic material, or the coating is hydrophilic.

[0096] It should 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 ensuing description or may be learned by the practice of the description. BRIEF DESCRIPTION OF THE DRAWINGS

[0097] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several embodiments of the present specification and, together with the description, serve to explain the principles of the present specification.

[0098] Figure 1 A representative endoscope for use with the disinfection systems and methods disclosed herein is shown;

[0099] Figure 2 is a cross-sectional view of a representative endoscope showing one or more lumens within the endoscope;

[0100] Figure 3 illustrates damage that may occur to a representative endoscope during use and / or cleaning with conventional devices;

[0101] Figure 4 is a side view of an exemplary embodiment of a cleaning and / or drying element;

[0102] Figure 5 A shows that Figure 4 Fluid pressure distribution generated by cleaning and / or drying elements;

[0103] Fig. 6A and 6B Show the use Figure 4 Direct pressure and shear stress pressures exerted by cleaning and / or drying elements on and along the internal cavities;

[0104] Fig. 7A is a side view of a cleaning and / or drying device comprising a plurality of cleaning and / or drying elements coupled to each other;

[0105] Figure 7B is a side view of another embodiment of a cleaning and / or drying device having a plurality of cleaning and / or drying elements;

[0106] Figure 7C is a perspective view of another embodiment of a cleaning and / or drying apparatus;

[0107] Figure 8 is a top view of a system for cleaning and / or drying an interior lumen within an endoscopic device;

[0108] Fig. 9 is a side view of a cleaning and / or drying element and a navigation element;

[0109] Fig.10 is a side view of an alternative embodiment of a cleaning and / or drying apparatus;

[0110] Figures 11A-11D Showing further alternative embodiments of the cleaning and / or drying apparatus;

[0111] Fig.12 is a side view of another embodiment of a cleaning and / or drying device incorporating a cleaning and / or drying element and a navigation element;

[0112] Fig.13 is a side view of a cleaning and / or drying element and a navigation device, illustrating a method for removably coupling the devices together;

[0113] Fig.14 Another method for removably coupling a cleaning and / or drying device to a navigation device is shown;

[0114] Fig.15 Another method for removably coupling a cleaning and / or drying device to a navigation device is shown;

[0115] Fig.16 Test data showing a comparison of pressures generated by the cleaning and / or drying elements disclosed herein and prior art devices;

[0116] Fig.17 Shown by Fig.16 The device generates peak pressure in the cleaning and / or drying area;

[0117] Fig.18 Shown by Fig.16 A device that generates positive pressure to clean and / or dry an area;

[0118] Fig.19 is a perspective view of an embodiment of a cleaning and / or drying apparatus according to an alternative embodiment;

[0119] Fig. 20 Show Fig.19 Use of a cleaning and / or drying device within a representative lumen of an endoscopic instrument;

[0120] Fig.21A and 21B Show Fig.19 Alternative embodiments of the cleaning and / or drying apparatus;

[0121] Fig. 22 is a perspective view of another embodiment of a cleaning and / or drying apparatus;

[0122] Fig.23 yes Fig. 22 a cross-sectional view of a distal end portion of a cleaning and / or drying device;

[0123] Fig.24 Another embodiment of a cleaning and / or drying device is shown;

[0124] Fig.25 An indexing element is shown for use with the cleaning and / or drying apparatus disclosed herein; and

[0125] Fig.26 Another indexing element for use with the cleaning and / or drying apparatus disclosed herein is shown. DETAILED DESCRIPTION

[0126] This specification and the accompanying drawings illustrate exemplary embodiments and should not be considered as limiting, wherein the claims (including equivalents) define the scope of this specification. Without departing from the scope of this specification and the claims (including equivalents), various mechanical, compositional, structural and operational changes may be made. In some cases, known structures and techniques are not shown or described in detail so as not to confuse the description. Similar reference numerals in two or more figures represent identical or similar elements. In addition, the elements and their associated aspects described in detail with reference to an embodiment may be included in other embodiments at any feasible time, in which other embodiments, they are not specifically shown or described. For example, if an element is described in detail with reference to an embodiment, and the element is not described with reference to the second embodiment, the element may still be required to be included in the second embodiment. In addition, the description herein is for illustrative purposes only and does not necessarily reflect the actual shape, size or dimensions of the system or the member shown.

[0127] Note that, as used in this specification and the appended claims, the singular forms "a," "an," and "the," as well as any use of the singular of any word, include plural referents unless expressly and unequivocally limited to one referent. As used herein, the term "include" and its grammatical variations 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.

[0128] Although the following description is primarily directed to endoscopes and devices for cleaning and / or drying endoscopes, it should be understood that the features of the presently described disinfection system may be readily adapted for use with a variety of reusable or disposable endoscopic instruments and devices that include an internal lumen or other internal space, such as endoscopes, trocars, cannulas, dilation devices, Foley catheters, guidewires, central venous catheters, bipolar or monopolar electrosurgical or ultrasonic devices, ventilators, respirators, CPAP and other positive airway machines, robotic and telesurgery equipment, arterial lines, drainage catheters, peripherally inserted central catheters, endotracheal tubes, feeding tubes, and other devices that are placed, penetrated, and / or navigated within the body.

[0129] The term "endoscope" as used herein generally refers to any viewing scope used in a medical application (which includes the body (human or other)) or in a medical application or in a non-medical application, and includes, for example, laparoscopes, arthroscopy, colonoscopes, gastroscopes, duodenoscopes, ultrasound endoscopes, bronchoscopes, enteroscopes, cystoscopes, laparoscopes, laryngoscopes, sigmoidoscopes, thoracoscopes, cardioscopes, and saphenous vein harvesters with viewing scopes (whether robotic or non-robotic).

[0130] When performing remote visualization inside a patient, a variety of scopes are used. The scope used depends on the extent to which the physician needs to navigate into the body, the type of surgical instruments used in the procedure, and the level of invasiveness appropriate to the type of procedure. For example, visualization of the inside of the gastrointestinal tract may involve endoscopy in the form of a flexible gastroscope and colonoscope, as well as a specialized duodenoscope that can be up to several feet in length and over 1 cm in diameter. The physician can rotate and articulate or manipulate these scopes as the scope is navigated through the patient. Many of these scopes include one or more working channels for delivering and supporting instruments, fluid channels and cleaning channels for flushing tissue and cleaning the scope, an insufflation channel for insufflation to improve navigation and visualization, and one or more light guides for illuminating the field of view of the scope.

[0131] Smaller and less flexible or rigid scopes, or scopes with a combination of flexibility and rigidity, are also used in medical applications. For example, when examining joints and performing arthroscopic surgery (such as surgery on the shoulder or knee), a smaller, narrower, and much shorter scope is used. When a surgeon uses arthroscopic surgery to repair a meniscus tear in the knee, the shorter, more rigid scope is typically inserted through a small incision on one side of the knee to view the injury, while instruments are passed through incisions on the opposite side of the knee. Instruments can flush the scope on the inside of the knee to visualize the location, and manipulate tissue to complete the repair.

[0132] Other scopes may be used for diagnosis and treatment using minimally invasive endoscopic procedures, including, by way of example and without limitation, the use of scopes to examine and treat conditions in the lungs (bronchoscope), oral cavity (enteroscopy), urethra (cystoscopy), abdomen and peritoneum (laparoscope), nose and sinuses (laryngoscope), anus (sigmoidoscope), and other aspects of the gastrointestinal tract (gastroscopy, duodenoscope, colonoscope), chest and thoracic cavity (thoracoscope), and heart (cardioscopy). Additionally, robotic medical devices rely on scopes for remote visualization of the area being assessed and treated by the robotic device.

[0133] These and other scopes can be inserted through natural orifices (such as the mouth, sinuses, ears, urethra, anus, and vagina) as well as through incisions and port-based openings in a patient's skin, cavity, skull, joints, or other medically indicated access points. Examples of diagnostic uses for visualization, endoscopic examinations using these medical scopes include investigating symptoms of disease, such as digestive disorders (e.g., nausea, vomiting, abdominal pain, gastrointestinal bleeding), or confirming a diagnosis (e.g., by performing a biopsy for anemia, bleeding, inflammation, and cancer) or surgical treatment of disease (such as removing a ruptured appendix, or cauterizing intragastric bleeding).

[0134] View now Figure 1, a representative endoscope 10 includes a proximal handle 12 suitable for being manipulated by a surgeon or clinician, the proximal handle being connected to an elongated shaft 14, and the elongated shaft 14 is suitable for being inserted into a body cavity of a patient through an endoscope or percutaneous puncture. The endoscope 10 also includes a fluid delivery system 16 connected to the handle 12 via a universal cable 15. The fluid delivery system 16 may include an internal lumen connected to the shaft 14 for delivering fluids (such as water and air), many different tubes for suction, and other features that clinicians may desire to divert fluids, blood, debris and particulate matter in the field of view. This provides a better observation of the tissue or material below for evaluation and treatment. In a representative embodiment, the fluid delivery system 16 includes a water spray connector 18, a water bottle connector 20, a suction connector 22 and an air tube 24. The water spray connector 18 is connected to an internal water spray lumen 28, and the internal water spray lumen 28 extends through the handle 12 and the elongated shaft 14 to the distal end of the endoscope 10. Similarly, the water bottle connector 20 , the suction connector 22 , and the air tube 24 are each connected to an internal lumen 30 , 32 , 34 , respectively, which passes through the shaft 14 to the distal end of the endoscope 10 .

[0135] The proximal handle 12 may include a variety of control devices for the surgeon or clinician to operate the fluid delivery system 16. In a representative embodiment, the handle 12 includes a suction valve 34 and an air / water valve 36 and a biopsy valve 38 for extracting tissue samples from a patient. The suction channel 34 extends from the suction connector 22 (in the suction connector, the suction channel 34 makes a relatively sharp turn or bend 22A) through the universal cable 15 to the handle 12. The suction channel 34 then extends through the shaft 14 to the distal end of the endoscope 10. When the suction channel 34 passes through the biopsy valve 38, it forms an internal Y-shaped joint 38B with the channel 38C extending into the biopsy valve 38. As discussed in more detail below, this Y-shaped joint 38b poses a challenge for cleaning / drying the suction channel 34 using conventional devices.

[0136] In some embodiments, the handle 12 may also include an eyepiece (not shown) coupled to an image acquisition device (not shown), such as a lens and light transmission system. The term "image acquisition device" as used herein also need not refer to a device having only a lens or other light directing structure. Instead, for example, the image acquisition device may be any device that can acquire and relay images, including (i) a relay lens between the objective lens and the eyepiece at the distal end of the viewing scope, (ii) an optical fiber, (iii) a charge coupled device (CCD), (iv) a complementary metal oxide semiconductor (CMOS) sensor. The image acquisition device may also be simply a chip for sensing light and generating an electrical signal for communication corresponding to the sensed light or other technologies for transmitting images. The image acquisition device may have a viewing end in which light is acquired. In general, the image acquisition device may be any device that can view an object, acquire images, and / or acquire video.

[0137] In some embodiments, endoscope 10 includes some form of positioning assembly (e.g., manual control) attached to the proximal end of the shaft to allow an operator to manipulate the scope. In other embodiments, the scope is part of a robotic element that provides maneuverability and positioning of the scope relative to a desired point to survey and focus the scope.

[0138] like Figure 2 As shown in , the endoscope 10 may also include a camera lens 62 for providing a view of the surgical site in the patient, a scope cleaner 32 and a light source 60, and a biopsy channel 50 for passing instruments therethrough. The biopsy channel 50 allows instruments to pass along the axis 14 of the endoscope 10 for removing tissue. The biopsy channel 50 may also be used as a working channel for other instruments to pass through the endoscope 10 for evaluating and treating tissue and other materials. Such instruments may include cannulas, catheters, stents and stent delivery systems, papillotomes, wires, other imaging devices including miniature scopes, cages, snares, and other devices used with scopes in the lumen. Alternatively, the endoscope 10 may include separate working channels for these instruments.

[0139] Figure 3 An internal lumen 70 of a representative endoscope is shown, such as a biopsy channel, a working instrument channel, or a water / air channel. As shown, the interior surface of the lumen 70 is either damaged during a previous procedure or damaged by conventional cleaning devices. Thus, the lumen 70 includes many defects 72 that provide minimal areas for pathogens, biological matter, tissue, or other debris to be contained therein. These defects 72 are difficult to clean and dry using conventional devices. In addition, because they contain biological matter, the biological matter protects the pathogens therein from conventional sterilization and disinfection techniques.

[0140] An exemplary cleaning and / or drying device will now be described. The cleaning and / or drying device comprises an elongated shaft and a cleaning and / or drying component disposed on a portion of the shaft. The cleaning and / or drying component can be removably attached to the shaft, or permanently attached to the shaft. The shaft can comprise any suitable material that provides enough rigidity for the shaft to advance through the lumen of the endoscope. The outer diameter that the elongated shaft has is sized to fit within the inner lumen in the endoscope 10 and to translate through the inner lumen. In an exemplary embodiment, the shaft will have an outer diameter ranging from about 0.5 to about 5 mm, preferably about 1 to 4 mm.

[0141] In certain embodiments, the device includes a pull cord configured to retract or advance the elongated shaft within the interior lumen of the endoscope 10. The device may also include an energy source and a motor for advancing and / or retracting the elongated shaft. Of course, it will be appreciated that the elongated shaft may be manually translated through the interior lumen via a proximal handle or a suitable actuator (i.e., without a motor).

[0142] View now Figure 4 , a portion of a cleaning and / or drying device 200 according to some embodiments will now be described. The cleaning and / or drying device 200 includes one or more cleaning and / or drying elements 300 attached to a push-pull element, such as a navigation element 301 (only a portion of which is in the Figure 4 ). The navigation element 301 can be advanced from the proximal end to the distal end of any internal lumen (or vice versa) with respect to the endoscope. For example, in one embodiment, the navigation element 301 is advanced from the biopsy channel of the scope to the distal end of the biopsy channel so as to exit from the biopsy channel and connect to the cleaning and / or drying element. The navigation element 301 can also be advanced from the proximal end of the biopsy channel of the scope to the distal end of the biopsy channel (or suction channel, if applicable) so as to exit from the biopsy channel and connect to the cleaning and / or drying element, or alternatively, advanced from the proximal end of the biopsy channel (or suction channel) through the channel and pulled to the distal end. The push and / or pull navigation element is attachable and also detachable in some embodiments, and can be permanently attached to the cleaning and / or drying element 300 in other embodiments.

[0143] like Figure 4, the cleaning and / or drying element 300 is a separate element that can be connected to the navigation element 301 so that the navigation element 301 can pass through the internal lumen of the endoscopic device. For example, the navigation element 301 can be advanced from the proximal end entrance to the biopsy channel 38C, released from the distal end of the biopsy channel along the biopsy channel 38C, and then connected to the cleaning and / or drying element 300 so that the entire system can be pulled up from the distal end of the scope to the biopsy channel and then exit the proximal end of the biopsy channel. This approach allows for successful cleaning of the biopsy channel without the problems of current technology, which accumulates debris and biological matter and pushes it out of the distal end of the biopsy channel, resulting in additional contamination at the most difficult to clean portion of the scope. This approach also allows for successful drying of the biopsy channel.

[0144] The unique ability to advance the navigation element and then connect to the cleaning and / or drying element at the distal end of the scope and withdraw the navigation element from the distal end to the proximal end provides successful cleaning and / or drying without increasing the contamination level at the distal end of the scope (which is the most difficult part of the scope to clean) or otherwise entering the deflection tube to pass through the Y-junction within the scope for proximal cleaning and / or drying through the preferred side of the Y-junction. This cleaning and / or drying approach can also be used to clean or dry other lumens within the scope, including the suction channel and the air / water channel (if applicable).

[0145] In other embodiments, the navigation element 301 and the cleaning and / or drying element 300 are adhered to each other and are advanced or retracted together through one or more lumens. The navigation element 301 and the cleaning and / or drying element 300 can be manufactured as one integral device, or they can be manufactured separately and attached to each other prior to use.

[0146] The channel element 300 includes a proximal end portion and a distal end portion, which are preferably at least two channel wall contact elements 302, 304, which are typically cylindrical in shape to match the shape of an endoscope channel. The wall contact elements 302, 304 make consistent circumferential contact with the inner wall of an endoscope channel, such as a biopsy channel or an aspiration channel. In certain embodiments, the channel element may include secondary wall contact elements 303, 305 (or additional contact elements if desired) to enhance the engagement between the wall contact elements and the interior lumen wall and ensure that the variable pressure zone (discussed below) is effective.

[0147] The channel contact element 302, 304 may include any suitable shape that substantially conforms to the wall of the internal lumen. In certain embodiments, the channel contact element 302, 304 preferably has a substantially circumferential, cylindrical or conical shape, wherein at least a portion of the element 302, 304 has a diameter that is approximately equal to or slightly greater than the diameter of the internal lumen. In an exemplary embodiment, the maximum diameter of the channel contact element 302, 204 is about 1 to about 1.5 times the diameter of the internal lumen, preferably about 1 to about 1.23 times the diameter. For example, if the diameter of the internal lumen is about 5 mm, the maximum diameter portion of the element 302, 304 may be about 4.2 to 5.5 mm, preferably about 5 mm. This additional size allows the elements 302, 304 to deform slightly as they pass through the internal lumen, ensuring that they will remain in contact with the lumen.

[0148] In certain embodiments, such as Figure 4 , the contact elements are substantially tapered so that they are angled downward in the proximal direction (or the direction of travel of the cleaning and / or drying device through the lumen of the endoscope). This configuration allows the contact elements 302, 304 to generate contact friction along the inner wall of the lumen so that they can slide along the wall of the interior lumen of the endoscope without getting stuck or otherwise caught in the lumen, while still ensuring that at least a portion of the contact elements 302, 304 remain in contact with the lumen. In an exemplary embodiment, the contact elements 302, 304 are approximately 0.75 mm and taper to approximately 0.5 mm at their distal ends (or contact points with the inner wall of the lumen).

[0149] The cleaning and / or drying element 300 also includes a variable pressure zone 306 between the wall contact elements 302, 304. The variable pressure zone 306 is designed to generate a variable pressure between the two circumferential contact elements 302, 304 and the wall of the cleaned channel. Therefore, when the cleaning and / or drying components are advanced in the channel and the sight glass and its channel are immersed in a cleaning fluid (the cleaning fluid can be saline or any other biocompatible material that can be safely used with an indwelling catheter according to the requirements of the sight glass manufacturer), when the cleaning and / or drying element moves through the inner cavity, the variable pressure design between the two circumferential elements generates eddies, venturi effects, inverted or reverse venturi effects or other variable pressures between the cleaning and / or drying element and the wall of the endoscope channel. As a result, when the cleaning fluid flows through the variable pressure zone, this affects the fluid flow when the fluid flow is transferred from the high pressure area across the low pressure area and then returns to another high pressure area between the two cylindrical elements. This will direct the cleaning fluid at the channel walls with increased velocity and force, similar to the Venturi effect created when one places one's thumb partially on the end of a garden hose to increase the force of the water released from the hose.

[0150] When used to dry a lumen, the forces generated by the variable pressure zone 306 enhance the drying performance of the element 300. These forces allow the cleaning and / or drying element to remove substantially all fluid and moisture from within the passageway.

[0151] Alternatively, the variable pressure zone 306 may be designed to create low pressure areas on either end of the zone 306, with the high pressure area located between the low pressure areas. In this embodiment, when the cleaning fluid or air flows through the variable pressure area, this affects the fluid flow as the fluid or air flow is transferred from the low pressure area across the high pressure area and then back to another low pressure area between the two cylindrical elements.

[0152] like Figure 4 , the variable pressure zone 306 includes a constriction section 308 coupled to the proximal contact element 302, a diffusion section 312 coupled to the distal contact element 304, and a throat section 310 coupling the diffusion section 308 and the constriction section 310. The throat section 320 has a diameter that is smaller than the diameter of the contact elements 302, 204 and larger than the diameters of the diffusion section 308 and the constriction section 310. The design enhances the performance of the cleaning fluid (or air, as applicable) by transitioning the fluid (or air, as applicable) from a static interaction point with the walls of the sight glass channel to a dynamic interaction point where the lifting action of the cleaning fluid's chemicals (or air in the case of drying) is enhanced by the direction of the fluid or air at the walls of the sight glass channel through the cleaning and / or drying components using pressure.

[0153] The variable pressure zone 306 may include an inverted partial venturi shape, a parabolic shape, a variable slope shape, or other such shape that creates a variable pressure between two cylinders and the wall of the cleaning channel, thereby increasing the force with which the cleaning fluid or air is ejected at the channel wall as the cleaning and / or drying components are advanced.

[0154] In an exemplary embodiment, the throat section 310 is substantially cylindrical. The diameter of the contraction section 308 preferably increases from the contact section 302 to the throat section 310, and the diameter of the diffusion section 312 preferably decreases from the throat section 310 to the contact section 304, thereby generating a vortex, a Venturi effect, an inverted or reverse Venturi effect, or other variable pressure between the distal end portion 302 and the proximal end portion 304 of the cleaning and / or drying element 310.

[0155] In a preferred embodiment, the variable pressure zone 306 has an inverted partial venturi shape with three different regions of various spacings from the wall of the sight glass channel, which produces an accelerated fluid dynamic effect or a similar effect with air to eject the cleaning fluid (or air) at the channel wall for more effective cleaning. These regions include a contraction section 308, which is the starting point of the region where the cleaning fluid (or air) exists on the other side of the first cylindrical element. The contraction section 308 is the starting point of the region in which the fluid accumulates and changes in the space available for the fluid, and when the cleaning and / or drying element 300 advances and the fluid (or air) is directed into the throat section 310 (which further changes the pressure between the cleaning and / or drying element and the channel wall), it becomes smaller, subject to a changing pressure. As the drying element 300 is advanced, the throat section 310 (wherein the shape available to the fluid is further reduced in a manner that changes the pressure on the fluid (or air) compared to the pressure on the fluid (or air) in the contraction section) produces an acceleration of the fluid (as cleaning) and / or air (as drying element 300); followed by a diffusion section 312, which supports the diffusion of the cleaning fluid (or air) at an accelerated rate as it exits the throat section. In general, these sections between the cylindrical elements produce a fluid dynamic force for the cleaning fluid that is sufficient to remove bacteria, biological matter and debris from the walls of the channel of the endoscope, or to produce a similar force with respect to the air to transfer water and moisture to dry the channel of the endoscope. This fluid dynamic force applied to the air is also sufficient to remove substantially all moisture and fluid from the lumen during the drying process.

[0156] The angle of the slope of the contraction section 308 (defined as the angle generated between the vertical section of the tapered section 302 and the slope section of the contraction section 308) can vary depending on the diameter of the cleaned channel, the viscosity of the fluid (or the concentration of the air), and other factors, and should be sufficient to support the variable pressure flow of the cleaning fluid or air between the cylinders when the cleaning and / or drying element is advanced. In certain embodiments, the angle defined by the contraction section and the proximal end portion (i.e., the contact section 302) is about 4 degrees to about 85 degrees, preferably between about 15 degrees and about 30 degrees. Similarly, the angle defined by the diffusion section and the distal end portion (i.e., the contact section 304) is about 4 degrees to about 85 degrees, preferably about 15 degrees to about 30 degrees. Of course, it will be recognized that the various pressure zones 306 may have more than one slope, curved shape, variable shape, or other such shapes that help to change the pressure between the two cylindrical elements 302,304.

[0157] Likewise, the angles between the contraction section 308 and the diffusion section 312 and the throat section 310 may vary depending on the diameter of the passage being cleaned, the viscosity of the fluid or air, and other factors, and should be sufficient to support variable pressure flow of the cleaning fluid or air between the cylinders as the cleaning and / or drying element is advanced. In certain embodiments, the 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.

[0158] The length and diameter of each segment of the variable pressure zone 306 are preferably selected to optimize vortex, venturi effect, inverted or reverse venturi effect or other variable pressure, and will vary based on the diameter of the internal lumen, the viscosity of the fluid or air, and other factors. For example, in a lumen having a diameter of about 4.2 mm, the length of the throat segment 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 the throat segment 310 will also depend on the diameter of the internal lumen and the diameters of the contraction segment 308 and the diffusion segment 312. In certain embodiments, the throat segment 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).

[0159] Preferably, the outer diameter of the navigation element 301 is smaller than the diameter of the throat region 310. In an exemplary embodiment, the diameter is less than about 2.5 mm, preferably less than about 2.0 mm, and more preferably about 1.75 mm.

[0160] The vortex, Venturi effect, inverted or reverse Venturi effect, or other variable pressure effecting fluid flow (and air flow, as applicable) created by the variable pressure zone 306 occurs when the fluid is transferred from the high pressure area across the low pressure area between the two cylindrical elements and then back to the other high pressure area so that the cleaning fluid or air is directed at the channel wall with increased force, similar to the Venturi effect created when one's thumb is partially placed on the end of a garden hose to increase the force of water released from the hose. The variable pressure design means that when the cleaning and / or drying element 300 is attached and withdrawn or pulled through the scope channel with the navigation element, the cleaning fluid or air in the channel and between the cylindrical element and the wall of the endoscope channel moves across the variable pressure area between the two cylindrical spheres to create a jet of cleaning fluid to pressurize the channel wall of the endoscope channel with the cleaning fluid, or to create air pressure to dry the channel wall.

[0161] This unique capability has the powerful effect of enhancing the performance of the cleaning fluid by transforming the fluid from a static interaction point with the sight glass channel wall to a dynamic interaction point where the lifting action of the cleaning fluid's chemicals is enhanced by the fluid (or air) direction of the cleaning and / or drying element at the wall of the sight glass channel using pressure. Computational models of fluid and pressure dynamics are used to show that in an embodiment, the application of the inverted venturi principle to generate variable pressure between two cylindrical elements directs the cleaning fluid (or air) at all channel walls with variable and increasing force fluid dynamic (or air) pressure to create a new high efficiency cleaning and / or drying capability that can remove debris, biological matter and bacteria from the channel, or dry, including addressing changes in channel surface topography, which is due to the ability to use fluid dynamics (or air) to direct the cleaning fluid into any scratches and breaks in the sight glass channel.

[0162] Computational modeling and test data evaluating the performance of the cleaning and / or drying elements indicate that the innovation affects the direction and force of the cleaning fluid or air, transforming the fluid from a static soaking detergent or air to an active pressure wash and clean and / or dry mode, where the variable pressure design of the cleaning and / or drying element creates a direct and beneficial fluid or air force against the walls of the channel. This pressure wash or air dry is in the form of a directional fluid dynamic force or air against the channel walls, a measurable force we refer to as fluid or air friction.

[0163] In an embodiment, the variable pressure zone 306 causes the cleaning fluid or air to be ejected at the channel wall with a pressure that exceeds the adhesion of bacteria or moisture that may be attached to the wall to produce a powerful benefit that does not exist in existing brushing technology. This ability enhances cleaning or drying, just like using a pressure washer to enhance the cleaning of external surfaces using detergents, such as using a pressure washer with detergent to remove contaminants from the side of a building or a sidewalk, or an air dryer. This innovation enhances cleaning fluid or drying in a completely new and powerful way, plus adding other features to its design, changing the channel cleaning performance so that the successful cleaning of the sight glass channel does not depend on the performance of a single element, such as the unpredictable wall contact force of a bristle brush or a pull-through cleaner, or the static performance of the cleaning detergent, or the drying based on evaporation over time. The variable pressure zone 306 of the cleaning / drying element 300 generates a fluid dynamic / air pressure that guides the detergent / air at the channel wall of the sight glass. The cleaning or drying action using hydrodynamic pressure to enhance the cleaning fluid performance or air drying and combined with mechanical pressure to do so is the best way to achieve consistent, predictable and repeatable success in removing biological matter and debris from the channels of an endoscope or other endoscopic instrument or removing moisture by drying without damage to these important channels.

[0164] The combination of the cylindrical elements and the variable pressure elements is important for generating fluid dynamics or air forces and it adds additional cleaning and / or drying forces by making non-invasive contact with the walls of the sight glass channel. These cylindrical elements add channel wall contact pressure as an additional cleaning or drying mode to remove debris and biological matter or dry from the channel walls as an additional complementary cleaning or drying capability working in conjunction with the variable pressure elements between the cylinders.

[0165] When the cleaning element is advanced through the lumen having a cleaning fluid or air therein, the variable pressure zone of the cleaning element is configured to generate fluid or air pressure relative to the inner wall of the lumen. In certain embodiments, the variable pressure zone is configured to generate a peak pressure of at least about 75Pa in at least one region between the distal end portion and the proximal end portion of the cleaning element. The peak pressure is preferably at least 100Pa and more preferably at least 125Pa. In an exemplary embodiment, the peak pressure may be about 150Pa. This direct pressure relative to the lumen wall is sufficient to remove substantially all biological matter or moisture from the inner surface of the lumen.

[0166] The variable pressure zone of the cleaning element is configured to generate a mean or average pressure of at least about 10 Pa, preferably about 20 Pa, and more preferably about 30 Pa across the distance between the proximal and distal end portions of the cleaning element. In an exemplary embodiment, the average pressure is about 36 Pa.

[0167] The variable pressure zone of the cleaning / drying element is also configured to generate a peak shear stress of at least about 4 Pa, preferably at least about 5 Pa, and more preferably at least about 8 Pa in at least one region between the distal end portion and the proximal end portion of the cleaning element. The mean or average shear stress across the distance between the proximal end portion and the distal end portion of the cleaning element is at least about 1 Pa, preferably about 2 Pa, and more preferably greater than 2.5 Pa. In an exemplary embodiment, the average shear stress is about 2.8 Pa.

[0168] The variable pressure zone of the cleaning / drying element is configured to generate a relatively high pressure across a relatively large footprint between the proximal and distal ends of the cleaning element. This increases the time that the inner surface of the lumen is subjected to the relatively high pressure, thereby increasing the amount of biological matter or moisture that can be removed using the device. For definitional purposes, applicants have referred to the peak cleaning pressure footprint (PPAC) as TM ) is defined as the distance between the proximal end and the distal end of the cleaning element where the variable pressure zone generates a pressure greater than 50 Pa. In certain embodiments, the cleaning / drying element is configured to generate a PPAC within 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.

[0169] The variable pressure zone of the cleaning / drying element is also configured to generate at least some positive pressure relative to the interior lumen across a relatively large footprint between the proximal and distal ends of the cleaning element. This increases the amount of time that the interior surface of the lumen is subjected to at least some cleaning or drying pressure, thereby increasing the amount of biological matter or moisture that can be removed using the device. For definitional purposes, applicants have referred to the positive pressure cleaning zone (+PAC) as TM ) is defined as the distance between the proximal end and the distal end of the cleaning element over which the variable pressure zone generates a positive pressure (i.e., above zero). In certain embodiments, the cleaning / drying element is configured to generate +PAC over at least about 25% of this distance, preferably at least about 50% of this distance, and more preferably at least about 75% of this distance. In an exemplary embodiment, the +PAC may be as high as 81%.

[0170] In an embodiment, a contraction ratio between the contraction section 308 and the throat section 310 may be determined, but this ratio may vary and depend on the following variables: the diameter of the cleaning scope channel, the hardness of the material used for the cleaning element 300, the expected speed and force applied by withdrawing the navigation element 301 after it is connected to the cleaning element 300 or otherwise advanced through the channel, the viscosity of the fluid used for cleaning or the air used for drying, the expected fluid friction of the cleaning fluid or air ejected by the cleaning element 300, and the direction of flow out of the throat section (including whether a narrow flow or a wider flow is desired with respect to the design).

[0171] The overall length of the variable pressure zone 306 will depend on a variety of factors, including, but not limited to, the diameter of the lumen, the viscosity of the fluid or air within the lumen, the specific shapes and angles of the contraction section 308, the throat section 310, and the divergence section 312, etc. In an exemplary embodiment, the length of the variable pressure zone is about 5 mm to about 20 mm, preferably about 10 mm.

[0172] Additionally, the angle of the surface of the diffuser section 312 may be a single plane or multiple planes. In embodiments, the angle of the surface of the diffuser section 312 increases the space between the wall of the endoscope channel and the cleaning element 300, in embodiments, in the diffuser section. As the cleaning element 300 is advanced through the endoscope channel, this change allows the fluid or air to accelerate out of the throat section at a higher pressure and velocity to create an elevated and increased fluid or air pressure against the wall of the endoscope channel.

[0173] In embodiments, the cleaning and / or drying element 300 may not have a three-section arrangement and may instead have other shapes and forms intended to vary the pressure between the two cylinders and create an elevated pressure sufficient to remove biological matter and debris from the walls of the channel of the sight glass or to dry the walls of the channel of the sight glass.

[0174] In embodiments, the delivery of fluid dynamics or air drying forces covers a significant area of ​​the channel of the sight glass between the two cylindrical elements, so that the application of the elevated forces caused by the cleaning element 300 is not narrow, but instead involves a wider elevated force, and thereby achieves greater success in removing biological matter and debris or drying. In certain embodiments, the fluid dynamics exceed the adhesion forces of bacteria commonly encountered in medical procedures, or the adhesion forces of moisture to the channel.

[0175] Figure 5 6 shows the overall flow pattern of fluid or air flowing through the cleaning / drying element 300 within the interior lumen of the endoscopic device. Figure 5 and 6A As shown in , the total pressure distribution between the cleaning / drying element 300 and the inner wall of the inner cavity produces a relatively low pressure area around the contraction section 308, a higher pressure area around the throat section 310, and an even higher pressure area around the diffusion section 312. The fluid power or air force points to a force level greater than 10Pa across at least 50% of the distance between the two cylindrical elements 302,304. In a preferred embodiment, the fluid power or air force points to a level greater than 10Pa across at least 75% of the distance between the two cylindrical elements 302,304. In an exemplary embodiment, the force is greater than 20Pa across at least 50% of the distance between the elements 302,304.

[0176] Figure 5 and 6A Also shown is the peak pressure formed around the diffuser section 312. As shown, in this region, the peak pressure can be as high as 100 Pa or more. In certain embodiments, the pressure throughout the diffuser section 312 is greater than 50 Pa.

[0177] As the cleaning element 300 is advanced proximally (or distally, depending on the direction of cleaning), the relative fluid or air velocity increases from one end to the other of the cleaning / drying element 300. Additionally, the diffuser section 312 creates a swirling fluid or air (not shown) within the diffuser section 312 that increases the pressure applied by the fluid or air to the inner wall of the lumen.

[0178] Figure 6B Further illustrate the viscous shear stress produced by the cleaning / drying element 300 along the inner wall of the inner chamber when the fluid passes between the element 300 and the inner wall. As shown, the shear stress is greater near the cylindrical element 302,304. Preferably, the peak shear stress is greater than about 4Pa, and more preferably greater than 7Pa. In an exemplary embodiment, the peak shear stress reaches about 8Pa or higher. The average shear stress across the entire inner wall from element 302 to element 304 is preferably greater than about 1.5Pa, and more preferably greater than 2.5Pa (almost reaching 2.8Pa in some embodiments).

[0179] In certain embodiments, the distance between the two cylindrical elements is any distance required for the variable pressure shape between the two cylindrical elements. In an embodiment, if the diameter of the channel of the cleaned sight glass is between 4 mm and 4.5 mm, the distance may be between 5 and 10 mm. In other embodiments, the distance may be a ratio relative to the diameter of the sight glass channel, such as less than 4:1, less than 2:1, or less than 1.5:1 or other ratios (distance: diameter of sight glass channel).

[0180] The diameter of the cylindrical element can be designed to avoid the deflection of the proximal end portion 302 and the distal end portion 304. The deflection of these cylindrical elements can be attributed to the buckling and the gap is generated, and the buckling causes the cleaning or drying effect to be unsatisfactory. This is one of the problems about the pull-through cleaner, which has a diameter as large as 5.2 mm, but is suitable for channels with diameters ranging from 2.8 mm to 5.0 mm, and must be buckled to advance through the channel. In an embodiment, the diameter of the cylindrical element is between 1.0 and 1.23 times the diameter of the channel of the cleaning or drying, so as to keep the cleaning / drying device 200 at the center of the clean channel, and the deflection of the end of the cylindrical element is minimal or limited. In addition, the deflection equation can be used to obtain the best cylindrical element.

[0181] If the diameter of the cylindrical element is too large relative to the channel size, this can result in inefficient cleaning or drying due to gaps in the cylinder, deflection of the cleaning / drying device, too much resistance to continuously pulling the cleaning / drying device 200 through the channel, and other problems. The material selected can also affect the results. In an embodiment, the material has a hardness between 35 and 70 Shore A, depending on the cylinder size and design, but different hardnesses and multiple hardnesses can be used in the same device.

[0182] In an embodiment, the size of the cleaning / drying device 200 may allow the cleaner to be advanced from the distal end without getting stuck on the elevator of the duodenoscope or ultrasound endoscope (which is a problem with current bristle brushes and pull-through cleaners), but the size of the cleaning / drying device 200 may also allow passage through the scope channel in the opposite direction, from proximal to distal.

[0183] In an embodiment, the cleaning and / or drying device 200 may have one or more absorbent sponges placed in the front or end of the cleaning and / or drying element 300, or placed between one or more of the cylindrical elements to absorb biological substances and debris and fluid. The absorbent sponge may be a single chamber structure, or a plurality of sponges with different chamber structures, to provide the scrubbing, absorption, promotion, diffusion or combination of these properties of the cleaning fluid. The absorbent sponge may be any material including polyurethane, polyvinyl alcohol or other absorbent materials. In an embodiment, the sponge is soft and non-traumatic when immersed in the fluid, and expands to a size that is at least the size of the channel size of the cleaning, and is larger than the channel of the cleaning in a preferred embodiment. The sponge may be any shape that meets and contributes to the channel of the cleaning and / or drying sight glass, for example, including but not limited to cylindrical shape, spiral shape, cone, triangle, square or any combination thereof. In an exemplary embodiment, the sponge has an aperture of about 200 to 1500PPC, preferably about 200PPC and about 600PPC.

[0184] The design of the cleaning device 200 can vary based on the viscosity of the cleaning fluid used to clean the sight glass channel. In a preferred embodiment, the cleaning fluid has the viscosity of water. The design of the cleaning device 200 can also vary based on the target temperature for immersing the sight glass for cleaning. In an embodiment, the target cleaning temperature is between 25 and 35 degrees Celsius.

[0185] In an embodiment, in addition to other aspects of the cleaning / drying element 300, the cleaning / drying device 200 may also include a brush of various designs that contacts a portion of the channel wall. The brush may be 1.0 to 1.4 times the length of the diameter of the channel to be cleaned or dried. In an embodiment, the brush is preferably made of a non-damaging polymer such as polyurethane, which has a thickness and hardness designed to limit trauma and damage to the channel wall while maintaining sufficient rigidity to remove contaminants or moisture from the wall of the channel. The diameter of the brush element that contacts the channel wall may be any diameter, but may be between .5 and 2 mm in an embodiment. The brush element may be perpendicular to the navigation element, and in some embodiments may be a part of a separate shorter navigation element that is designed to reach only some limited distances in the biopsy channel. The shorter version may be any length that is suitable for cleaning or drying the initial entry point into the biopsy channel, but in a preferred embodiment is between 4.5 and 15 cm long. The brushing element (whether a part of the cleaning element or a separate shorter version) may also use nylon bristles or other bristles (if arranged in a pattern that effectively cleans or dries and minimizes trauma to the viewing mirror channel). The grasping element of the brush may have a larger shape at one end or in the center of the element to facilitate introduction into the biopsy channel.

[0186] In some embodiments, the cleaning and / or drying device 300 may include a plurality of cylindrical elements with variable pressure elements between the cylindrical elements, such as a series of five groups of cylindrical elements with variable pressure elements between each of the cylinders. The variable pressure elements may be identical, or may vary to produce alternating pressure curves. The plurality of cylindrical elements with variable pressure elements between the cylindrical elements may be more or less than five groups, depending on a given application.

[0187] View now Figure 7B , an embodiment of the cleaning and / or drying device 400 with multiple cleaning and / or drying elements 300 will now be described.As shown, each cleaning and / or drying element 300 comprises a proximal end portion 302 and a distal end portion 304 and a variable pressure zone 306 therebetween, as described above.Proximal end portion 302 and distal end portion 304 are preferably cylindrical or annular elements, which have an external diameter (as discussed in detail below) substantially the same as the internal diameter of the inner chamber to be cleaned.In this embodiment, cleaning and / or drying elements are coupled to each other at proximal end portion and distal end portion.In an exemplary embodiment, the proximal end portion of a cleaning and / or drying element is integral with the distal end portion of a next cleaning and / or drying element, but it will be appreciated that other configurations are also possible. For example, the cleaning and / or drying device 400 may have more than one cylindrical element placed next to another cylindrical element with a spacing that does not produce a variable pressure, followed by a cylindrical element or alternatively preceded by a cylindrical element with a spacing between the cylindrical element and the next cylindrical element that produces a variable pressure between the cleaning and / or drying element 300 and the wall of the channel being cleaned. In an embodiment, a series of cylindrical elements may be organized at various spacings to produce a variable pressure between the cylindrical elements, and at a certain spacing to produce a constant pressure between the cylindrical elements.

[0188] The cylindrical / annular elements 302, 304 may be made of any shape and size that makes contact and at least partially conforms to the wall of the channel being cleaned, including, in some embodiments, cylindrical elements with tapers, reverse tapers, cylindrical elements that deflect and contact each other or deflect and do not contact another cylindrical element, or cylindrical elements that contact or do not contact variable pressure shapes between cylindrical elements. The cylindrical elements do not have to be cylindrical, but need to be able to assist in producing variable pressure results with the rest of the elements of the cleaning and / or drying device 400, meaning that they must have wall contact that is meaningful enough to support the creation of variable pressure areas to accelerate fluid or air flow, and thereby use fluid dynamics or air pressure to direct the cleaning fluid or air at the channel wall.

[0189] In certain embodiments, the cylindrical / annular elements 302, 304 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 misalignment (which is a problem with existing brushes and pull-through cleaners) occurs, the brushes and other elements are pulled to one side of the lumen as the cleaner is pulled around the curves, corners, and junctions of the lumen, with the result that contact with the lumen wall and the cleaning and / or drying element (whether a brush, pull-through cleaner, or other cleaner) is minimized, adversely altered, or lost, resulting in an adverse effect on the effectiveness of the cleaning and / or drying approach. This problem is corrected by placing a centering element at the front or back of the device, or both, 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.

[0190] The cleaning device 400 can be designed to capture a certain volume of debris relative to the size and contamination level of the channel being cleaned, or to capture a certain level of moisture using drying. For example, additional cylinders and variable pressure elements can be added to increase the length of the cleaning device 400 to capture and remove more contaminants or moisture. Additionally, in embodiments, one or more sponges of various pore sizes, diameters, and lengths can be added to increase the removal of contaminants or moisture.

[0191] In an embodiment, each cleaning and / or drying element 300 is between 2.5 cm and 7.5 cm in length, and the cleaning and / or drying device 400 comprises a plurality of variable pressure zones separated by a plurality of cylindrical elements. In a preferred embodiment, the cleaning and / or drying device 400 comprises five variable pressure zones separated by six cylindrical elements. In certain embodiments, the cleaning and / or drying device 400 may include two additional cylindrical elements 402, 404 at the distal end of the device 400.

[0192] View now Fig. 7A , another embodiment of the cleaning and / or drying device with multiple cleaning and / or drying elements will now be described.As in the previous embodiment, each cleaning and / or drying element 300 comprises a proximal end portion and a distal end portion and a variable pressure zone between them, as described above.Proximal end portion and distal end portion are preferably cylindrical elements, which have an external diameter substantially the same as the internal diameter of the inner chamber to be cleaned (as discussed in detail below).In this embodiment, cleaning and / or drying elements are coupled to each other at proximal end portion and distal end portion.In an exemplary embodiment, the proximal end portion of a cleaning and / or drying element is integral with the distal end portion of a next cleaning and / or drying element, but it will be appreciated that other structures are also possible.

[0193] In this embodiment, the cleaning and / or drying device also includes one or more substantially cylindrical cleaning and / or drying components 422 located at or near the proximal end of the cleaning and / or drying device. The cleaning and / or drying components 422 are substantially cylindrical and therefore do not include the variable pressure zones discussed above.

[0194] The cleaning and / or drying device may also include a centering element 424 located on either or both of the proximal end portion and / or distal end portion of the cleaning and / or drying device. The centering element 424 is used to center the navigation element 301 and the cleaning and / or drying device when the device is pulled or pushed through the lumen around turns and navigates through corners and other complex areas (including the junctions of multiple lumens and internal channels in sight glasses or other instruments for cleaning). In embodiments, the centering element 424 may be smaller than the diameter of the lumen through which the device is advanced, but has a sufficiently large size to prevent the navigation element 301 from misaligning and deflecting to one side or the other of the lumen when it is navigated (including when the cleaning and / or drying device is pulled or pushed around the curves, corners and junctions (including Y-shaped junctions) of various lumens).

[0195] The centering element 424 can 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 misalignment (which is a problem with existing brushes and pull-through cleaners) occurs, the brushes and other elements are pulled to one side of the lumen as the cleaner is pulled around the curves, corners, and joints of the lumen, resulting in minimized, adversely altered, or lost contact with the lumen wall and the cleaning and / or drying element (whether a brush, pull-through cleaner, or other cleaner), resulting in an adverse effect on the effectiveness of the cleaning and / or drying approach. This problem is corrected by placing a centering element at the front or back of the device, or both, resulting in more consistent effective cleaning and / or drying, especially around curves, corners, channel joints, and other complex areas inside the endoscope or other endoscopic instrument or device.

[0196] In some embodiments, the centering element (424) may include a series of shaped elements protruding from the elongated member or the navigation member. The series of shaped elements may include, for example, pillars, spikes, or other protrusions extending radially outward from the elongated member and sized to substantially center the elongated member and / or drying / cleaning element within the interior passage of the endoscopic device.

[0197] In a preferred embodiment, the centering element 424 is between 50 and 90 percent of the clean lumen diameter, with another preferred embodiment having a diameter or height between 70 and 85 percent of the clean lumen diameter. The centering element 424 can be any shape that keeps the cleaning and / or drying element centered when the cleaning and / or drying element navigates through the passage. In an embodiment, this includes cylindrical, conical, spherical, and the centering element can be placed at the distal region of the device, at the distal end and the proximal end, between the cleaning and / or drying components, or at the proximal end (as the case may be) to help center the cleaning and / or drying element, especially when it navigates around curves, across Y-shaped joints, and other aspects of the lumen.

[0198] View now Figure 7C , another embodiment of the cleaning and / or drying device 800 will not be described. As shown, the device 800 includes a plurality of cleaning and / or drying elements 300, wherein each cleaning and / or drying element 300 includes a proximal end portion 302 and a distal end portion 304 and a variable pressure zone 306 between them, as described above. The proximal end portion 302 and the distal end portion 304 are preferably cylindrical elements, which have an outer diameter substantially the same as the inner diameter of the lumen to be cleaned (as discussed above). In this embodiment, the cleaning and / or drying elements are coupled to each other at the proximal end portion and the distal end portion.

[0199] The cleaning and / or drying device 800 includes two additional cylindrical elements 402, 404 located at the distal end of the device 800. In certain embodiments, the cylindrical / annular elements 402, 404 can 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. By placing a centering element at the front or back of the device, or both, this problem is corrected, resulting in more consistent effective cleaning and / or drying.

[0200] In this embodiment, the device 800 also includes a proximal end element 802 and a proximal cylindrical centering element 804 disposed around the variable pressure zone 306. The element 804 is preferably disposed around the contraction section 308 of the pressure zone 306 between the divergent section 312 and the throat section 310 (see Figure 4 and the above description of these elements).

[0201] Centering element 804 is positioned around pressure zone 306, rather than at the proximal end of the device (eg, Figure 7B800). The centering element 804 is sized so that its outer surface contacts the interior surface of the lumen of the endoscopic device. As the device 800 is pulled or pushed through the lumen, the centering element 804 engages the interior surface of the lumen and displaces any biological matter (cleaning) and / or moisture (drying) on ​​the surface, moving the material forward with the device 800. In the event that the displaced biological matter or moisture does not move forward, it is captured by one of the pressure zones 306, as described above.

[0202] Fig. 27 A kit 900 is shown that includes a water bottle 902 having a straw 904 and a cleaning and / or drying device 910 for the straw 904. In this embodiment, the device 910 can be used to clean and / or dry interior surfaces of drinking containers and components of drinking containers, such as drinking straws, drink containers, water containers, bottles, thermoses, pitchers, jugs, carafes, baby bottles, water bottles, and insulated drink containers and drinking straws for any of these containers.

[0203] As shown, the device 910 includes a plurality of cleaning and / or drying elements 300, wherein each cleaning and / or drying element 300 includes a proximal end portion 302 and a distal end portion 304 and a variable pressure zone 306 between them, as described above. The proximal end portion 302 and the distal end portion 304 are preferably cylindrical elements having an outer diameter substantially the same as the inner diameter of the lumen to be cleaned or dried (as discussed above). In this embodiment, the cleaning and / or drying elements are coupled to each other at the proximal end portion and the distal end portion.

[0204] The cleaning and / or drying device 910 includes two additional cylindrical or annular elements 402, 404 located at the distal end of the device 910. In certain embodiments, the cylindrical / annular elements 402, 404 can 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. By placing a centering element at the front or back of the device, or both, this problem is corrected, resulting in more consistent effective cleaning and / or drying.

[0205] In this embodiment, the device 910 also includes a proximal end element 908 and a proximal cylindrical centering element 906 (formed on the proximal side of the proximal cleaning and / or drying element 300). The end element 908 preferably includes a substantially cylindrical plug-shaped element that forms the proximal end of the device 910. The end element 908 is used to guide the device 910 through the straw 904 and drain moisture and / or biological matter from the interior surface of the straw, and thereby clean and / or dry these surfaces. In certain embodiments, the device 910 may also include a distal end element (not labeled) that is substantially the same design as the proximal end element 908.

[0206] Figure 8 A system 450 for advancing a cleaning and / or drying device 400 through one or more lumens of an endoscopic device is shown. As described above, the cleaning and / or drying device 300 is coupled to a navigation device 301, which may, for example, include an elongated wire, tube, filament, or similar member that is flexible but has sufficient rigidity to be advanced through the lumen. The navigation device 301 is coupled to a pulling element 454, which may include, for example, a flexible silicone or plastic tube having a sufficient length to pass through the entire lumen of, for example, an endoscope.

[0207] like Fig. 9 As shown in , the pulling element 454 can be molded to provide frictional resistance so that the navigation device 301 can be advanced into the tube, but the friction makes it difficult to withdraw the device 301 from the pulling element 454. In this way, when the pulling element 454 is withdrawn through the lumen of the endoscope, the cleaning and / or drying element 300 will follow the pulling element 301 through the lumen.

[0208] like Fig.25 and 26 As shown in , the system may also include a guiding element ( Fig.25 750 and Fig.26 760 in the figure) to help the cleaning and / or drying device 200 pass through certain difficult areas of the endoscope. In particular, the guiding element prevents the navigation element from being deflected into the wrong channel when passing through internal junctions between multiple channels (such as the Y-shaped junction 38B between the suction channel 22 and the biopsy channel 38C). Alternatively, the guiding device can be used to navigate the cleaning and / or drying device through sharp turns or bends in the lumen of the endoscope.

[0209] In use, the guiding element 750 or 760 can be inserted into one of the internal channels of the observation scope (such as the biopsy channel 38C or the suction channel 22) to help transfer the cleaning and / or drying device 200 from the distal end of the observation scope 10 to the proximal end of the biopsy channel 38C or the suction channel 22 to facilitate cleaning and / or drying in a manner that pulls debris away from the complex, difficult-to-clean distal end of the observation scope in a distal to proximal motion.

[0210] View now Fig.25, the guiding element 750 comprises a hollow tube, such as a tubular sheath or the like, which can be temporarily inserted into a desired branch of the internal junction between the two channels so that a portion of the cleaning and / or drying device 200 enters or engages with the guiding element 750 as it is advanced through the channels and deflects or enters the guiding element 750 to avoid advancing the cleaning and / or drying device 200 into an unintended side of the junction or intersection of the internal channels. For example, when cleaning and / or drying the biopsy channel portion 38C of the scope 10, if the navigation element of the cleaning and / or drying device 200 is advanced from the distal end to the proximal end of the channel (i.e., from the distal end of the shaft 14 toward the biopsy valve 38), the navigation element will need to pass through the internal Y-shaped junction 38B to advance the last portion of the biopsy channel 38C upward. In some embodiments, the guiding element 750 can be inserted from the entry point through the Y-shaped junction 38B into the biopsy channel 38C, so that the navigation element of the cleaning and / or drying device 200 enters or engages with the guiding element and is released at the end of the biopsy channel 38C, rather than being deflected at the Y-shaped junction 38B and advanced toward the suction portion of the endoscope [e.g., see Figure 1 Suction valve 36].

[0211] In a similar manner, the guidance element 750 can be inserted from the suction valve 36 and pushed just through the internal Y-joint 38B so that the navigation element of the cleaning and / or drying device 200 is transferred from the distal end of the viewing mirror to the proximal end of the suction channel without potential deflection of the navigation element at the internal Y-joint 38B.

[0212] If desired, the guiding element 750 can also be used to assist in navigating sharp internal turns in the internal channel of the endoscope (such as Figure 1 The outlet of the passage 22 in the cleaning and / or drying device 200 is provided, and if necessary, other aids for advancing the navigation element or the cleaning and / or drying element.

[0213] In some embodiments, the guiding element 750 is tubular or cylindrical, having an outer diameter that is smaller than the inner diameter of the internal lumen (e.g., biopsy channel 38), and the internal lumen has a diameter that is at least greater than the diameter of the navigation element of the cleaning and / or drying device 200. In a preferred embodiment, the guiding element 750 is shaped to fit as closely as possible the diameter of the scope channel that leads to the internal Y-shaped junction 38B or other internal area of ​​the scope 10, and its length reaches or extends beyond the junction 38B, which in some embodiments may be between 8 and 20 cm. As another preferred embodiment, for a scope having an internal channel with a diameter of 4.2 mm, the outer diameter of the guiding element will be between 3.5 mm and 4.15 mm, and the inner diameter will be between 1.5 mm and 4.05 mm.

[0214] In an embodiment, the guide element 750 may include an angled end to further conform to the shape of a multi-channel internal joint within a scope. In an embodiment, the proximal end of the guide element 750 may have a flange that is larger than the entry opening of a particular scope channel into which the navigation element is inserted, so that the navigation element may not be fully advanced into the channel and may be difficult to withdraw. In an alternative embodiment, the guide element 750 may not have a flange, but may have indicia, including, for example, a pad-printed line or other line, to mark the most recommended point for advancement of the navigation element into the scope channel.

[0215] Fig.26 Another embodiment of a guide element 760 is shown, which includes a substantially circular rod having an angled distal end so that the elongated navigation member 301 can pass from the distal end of the scope to the aspiration valve opening while being deflected upward into the biopsy channel 38C at the Y-shaped junction 38B. In an embodiment, the proximal end of the guide element 760 can have a flange that is larger than the entry opening of the particular scope channel into which the guide element is inserted, so that the guide element cannot be fully advanced into the channel and causes difficulty in retraction. It can also include an angled cutout at its distal end to further conform to the shape of the multi-channel internal junction in the scope.

[0216] Fig.10 Another embodiment of a cleaning and / or drying device 500 is shown, which has a plurality of cleaning and / or drying elements 502a, 502b coupled to a navigation element 504. As shown, the cleaning and / or drying elements 502a, 502b each include a cylindrical wall contact portion 506 and a variable pressure center portion 508. In this embodiment, each center portion 508 of the cleaning and / or drying elements 502a, 502b includes at least one contraction portion 510 angled downward and then a throat portion 512 angled toward the inner cavity wall again upward 512. As shown, the cleaning and / or drying element 502a includes an additional portion 514, which also includes a contraction portion and a throat portion, forming two independent variable pressure elements in a single cleaning and / or drying element 502a. The cleaning and / or drying element 502b includes only one variable pressure zone, but it will be understood that various combinations of these features may be included. For example, cleaning and / or drying device 500 may include multiple cleaning and / or drying elements, each of which includes multiple variable pressure zones. Alternatively, as shown in relative to cleaning and / or drying element 502b, each of the cleaning and / or drying elements may only include a variable pressure zone. As in the previous embodiment, the combination of these sections produces variable pressure, which causes high shear stress to the wall on the inner chamber.

[0217] Figures 11A-11D Other configurations of variable pressure zones for cleaning and / or drying elements are shown. Fig.11A , cleaning and / or drying element 560 includes a converging section 562 , the angle between converging section 562 and throat 566 being greater than the angle between throat section 566 and diverging section 564 . Fig. 11B A cleaning and / or drying element 570 is shown that does not include a specific throat section. As shown, the cleaning and / or drying element 570 includes a convergent section 572 that immediately forms a divergent section 574 (ie, angled toward the lumen and then angled inward without a central cylindrical throat section).

[0218] Fig. 11C and 11D A cleaning and / or drying element 550 is shown that creates multiple high pressure zones by including more than one throat section 552. Additionally, a series of cleaning and / or drying elements may each have a different configuration. As shown, in some cases, a cleaning and / or drying element having a single throat section may be followed by a cleaning and / or drying element having multiple throat sections, or vice versa.

[0219] Fig.12 Yet another embodiment of a cleaning and / or drying device 600 is shown, which includes a cleaning and / or drying element 602 and a navigation element 604. In this embodiment, the navigation element 604 includes an infusion lumen 608 for delivering air or additional fluid to the cleaning and / or drying element 602. The cleaning and / or drying element 602 includes one or more infusion ports 606 for delivering air and / or fluid into a variable pressure zone within the lumen created by the cleaning and / or drying element 602. Delivering fluid into the variable pressure zone increases the pressure therein, which thereby increases the force of the fluid or air relative to the inner wall of the lumen to be cleaned.

[0220] The cleaning and / or drying device 400 may be non-sterile, disinfected, or sterilized using a suitable sterilization method, including e-beam, gamma, ETO gas, hydrogen peroxide, steam, etc. Where the device 400 is used for drying, it is typically sterilized.

[0221] The material used for the navigation element 301 can be any material sufficient to navigate through the clean channel and capable of managing the pulling force associated with advancing the cleaning and / or drying element 300 through the clean channel. This includes all metal- and polymer-based materials, including stainless wire, nitinol and other metals. It also includes all polymer-based materials in any other form, whether in the form of monofilament, extruded tube, braid or sufficient to facilitate the advancement of the cleaning and / or drying element 300 through the clean channel. In a preferred embodiment, the navigation element 301 is a monofilament made of nylon, polyamide, polyurethane, PET or other polymer materials, having a diameter of at least 1mm. The navigation element 301 can include a gripping element at one end that is convenient for holding and transmitting the navigation element 301. In an embodiment, the gripping element is larger than the entry point of the biopsy channel to protect against excessive advancement of the navigation element 301 into the biopsy channel and loss of the grip of the navigation element 301 by the person.

[0222] In an alternative embodiment, the navigation element 301 includes one or more internal channels that allow the cleaning fluid or air to be infused to one or more ports along the navigation element 301, and also allow the fluid to be aspirated if desired. An infusion port may be present in the cleaning and / or drying device 300 to release the fluid or air that is propelled through the navigation element 301, allowing the cleaning fluid or air to be infused into the cleaning device 200 through the navigation element 302 to further change and increase the hydrodynamic pressure of the cleaning fluid against the channel walls. In an embodiment, the navigation element 301 and the cleaning element 302 may also include one or more aspiration channels that can be used to circulate the cleaning fluid or air and / or flushing fluid more quickly and to extract debris and fluid or moisture through the aspiration channels.

[0223] In some embodiments, the navigation element 301 can be attached to the cleaning and / or drying element 300 by permanent attachment, which can be by molding, overmolding, overmolding, glue or other means to create an attachment between the navigation element and the cleaning and / or drying element, wherein the two elements are fixed or attached for use. In a preferred embodiment, the navigation element 301 is separately attachable, and in some embodiments is attachable and removable, so that the navigation element 301 can be attached from one end of the channel to the other end, exit the channel and then attached to the cleaning and / or drying element 300. The attachment means can be any manner suitable for the intended use, for example, can include interlocking elements, compression fittings, slide and lock mechanisms, loop and hook mechanisms, insertion and twist mechanisms, or variations and alternative combinations of diameters and shapes suitable for the navigation element and the cleaning and / or drying element.

[0224] Figure 13-15 Three different embodiments are shown for removably attaching a shaft 400 (such as a navigation element) to a cleaning and / or drying element 402. Fig.13As shown in , the cleaning and / or drying element 402 may include a recess 404 for receiving a protruding section 406 of the shaft 400. Fig.15 As shown in FIG. 4 , the shaft 400 may include one or more barbs 410 that fit within an opening 412 of the cleaning and / or drying element 402. The shaft 400 may include a flexible section 414 to allow the barbs 410 to fit within an interior cavity of the cleaning and / or drying component 402. Fig.14 As shown in , shaft 400 may include one or more protrusions 420, which can be rotated into the grooves on the cleaning and / or drying components 402 to attach the cleaning and / or drying components to the shaft. It will be appreciated by those skilled in the art that the devices and methods disclosed herein are not limited to these embodiments. For example, other methods for connecting shaft 400 to cleaning and / or drying elements 402 include, but are not limited to, flat monofilaments, silk, ropes or filaments, crimping, press-fit elements, protrusions engaged with holes, channels or other openings, heat melting, heat bending, heat perforation, hooks, snap-fit ​​elements, etc., connected to releasable or non-releasable knots.

[0225] In a method according to some embodiments, a navigation element 301 is advanced through a lumen of an endoscopic instrument, such as the biopsy channel 50 of the endoscope 10. The lumen is filled or partially filled with a fluid, such as an enzyme detergent or other cleaning fluid. The fluid is used to initially clean and / or disinfect the lumen to remove at least some of the biological matter and other pathogens from the lumen. Once the distal end portion of the navigation element 302 has passed through the distal end opening of the lumen, the cleaning element 300 is removably attached to the navigation element 301 by one of the above-described devices and methods.

[0226] After the cleaning and / or drying element 300 is attached to the navigation element 301, the navigation element 301 is withdrawn through the lumen of the instrument. In certain embodiments, the device 200 includes a pull cord configured to withdraw or advance the elongated shaft 301 within the interior lumen of the endoscope 10. The device may also include an energy source and a motor for advancing and / or withdrawing the navigation element 301. Of course, it will be appreciated that the navigation element 301 may be manually translated through the interior lumen via a proximal handle or a suitable actuator (i.e., without a motor).

[0227] As the navigation element 301 is withdrawn through the lumen, each cleaning and / or drying element 300 generates its own variable pressure zone between the proximal end 302 and the distal end 304. Specifically, the variable pressure zone 306 increases the relative velocity between the fluid within each cleaning and / or drying element 300 and the walls of the cleaning and / or drying element 300, which causes the fluid to accelerate relative to the inner wall of the lumen, thereby generating greater fluid forces on the walls (as discussed in more detail above). This increased fluid force provides more effective cleaning and / or drying than conventional devices.

[0228] The navigation element 301 can be manually or via a motor to be withdrawn through the inner cavity, as described above. Preferably, the navigation element 301 is withdrawn at a predetermined speed, such as about 20-50 cm / sec, preferably about 30 cm / sec. Applicants have found that withdrawing at this speed optimizes the effect of the variable pressure zone 306 on the fluid in the cleaning and / or drying element 300.

[0229] The navigation element 301 may be withdrawn only once, or it may be advanced again and withdrawn a second or third time, depending on the specific cleaning and / or drying requirements. In some embodiments, 301 is only partially withdrawn through the lumen before it is advanced again so that the cleaning and / or drying element does not push biological matter and other debris from the proximal end portion of the scope (i.e., the biopsy channel) back into the lumen.

[0230] Also provided is a kit for cleaning and / or drying an endoscopic instrument. The kit includes any of the above-described cleaning and / or drying devices and may include an endoscopic instrument or an endoscope, such as described above with reference to Figure 1 Any of the endoscopes described, or other endoscopes known to those skilled in the art. Additionally or alternatively, the kit may include various other devices for any combination of cleaning and / or drying procedures, such as cleaning brushes, cotton swabs and / or sponges, enzyme cleaners, disinfectants, and other devices and reagents for sterilizing and / or disinfecting medical devices, sight glass desiccants, test strips or other sensors for determining the effectiveness of such cleaning and / or drying devices (i.e., detecting the presence of proteins, biological matter, bacteria, fungi, viruses, proteins, ATP or bacterial markers or other pathogens), personal protective equipment (PPE), sight glass housings for transporting sight glass to and from, for example, a reprocessing location, contamination bags, etc.

[0231] Another kit provided herein includes a cleaning device and a drying device. In certain embodiments, the cleaning and drying device may include one or more of the above-described embodiments. The kit may include an unsterilized cleaning device and a sterilized drying device. Alternatively, the kit may include a device for both cleaning and drying the inner lumen of an endoscopic device. In an embodiment, the cleaning device may be one color, and the drying device may be a different color, so that the user can easily determine the purpose of each device. This helps to identify the purpose of each device and helps to clarify which device is sterilized after it is opened. The color difference may be in the navigation element, cleaning / drying element, pad printing line or other markings to clarify the different purposes of each device.

[0232] In certain embodiments, the kit includes a cleaning device (such as one of the above embodiments) and a drying device, the drying device including a propulsion element, which can be a filament, a wire, a tube, or other elements capable of propulsing the element into an internal passage, including a long passage, a curved passage, or other passages that are difficult to access because they are recessed or located inside. In an embodiment, once the element is pulled through the internal passage, the element can be grabbed at the end and then pulled through the passage as part of the drying process. It can also be pushed from the other end by pushing the propulsion element. The element may include a version that is capable of propulsing air through the device and into the passage (including reaching a removal position inside the passage), and exceeds the typical effectiveness of forced air drying in the passage.

[0233] The drying component may include one or more substantially cylindrical components spaced apart from each other along the propulsion component. The cylindrical component is configured to maintain contact with the channel wall when the propulsion element advances through the channel to transfer and remove any moisture. The propulsion element may be advanced by being pushed, pulled, or by other means, including stirring back and forth, advancing, and withdrawing based on a pattern. The propulsion element may advance through the sight glass by combining an automated or mechanized approach or any other means that moves the channel drying element through the channel to transfer, absorb, and / or remove water at least in part by direct contact with the surface area to be dried.

[0234] In an embodiment, the drying component may include a series of one or more cylindrical scrapers, which are designed to make wall contact with the inner wall of the channel to remove fluid and moisture from the channel. These cylindrical scrapers can be arranged in any way to effectively remove liquid and moisture from the channel. Depending on the channel diameter, length, curve, junction with other channels and other factors, this includes two and then three scrapers in groups, or vice versa, or other configurations of scrapers, such as one and then two scrapers in groups, two and then four, three and three, four in a row, five in a row, or any other number and configuration of scrapers that effectively remove water and moisture.

[0235] In embodiments, some of these scrapers may have different heights to make the device more suitable for use with different sized channels. For example, the device may have a scraper with a diameter of 5 to 5.2 mm, followed by a smaller scraper with a diameter of between 2 and 2.2 mm, followed by another scraper with a diameter of 3.8 to 4 mm to create variable wall contact across various channel sizes. In embodiments, the height and arrangement of the scrapers are not limited to this specification, and these diameters, positions, scraper thicknesses, etc. should vary based on what is most effective for drying a given channel drying application.

[0236] The spacing between the scraper and any other elements (including the drying elements) can be any spacing that supports fast and predictable tunnel drying, including spacing of 1 mm, 1.25 mm, 1.5 mm, 2 mm, a close spacing of 1.25 mm followed by a 4 mm gap followed by a spacing of 1.25 to 1.5 mm, or other spacings that are closer or farther or more variable that optimize and support fast and predictable tunnel drying. In embodiments, the spacing, diameter, and arrangement and grouping of drying elements can vary based on tunnel size, tunnel material, the number of curves to navigate around, the number of junctions with other tunnels (if any), tunnel dryer material, and other factors specific to a given tunnel drying application.

[0237] The thickness of the scraper, disk and fins is any thickness that facilitates channel drying and positioning the fins and scrapers for drying and in some embodiments cleaning. In embodiments, this includes scraper and fin thicknesses between 0.2 and 0.5 mm; other variations with thicknesses of 0.5 to 1.0 mm; other variations with tapered thicknesses where the thickness at the base of the scraper or fin is greater and tapers closer to the channel wall to enhance element deflection and conformity of the element to the channel wall while providing support and some rigidity and flexibility around the propulsion element.

[0238] In an embodiment, the innovation includes a centering element so that the drying element remains centered as it is advanced through the channel to dry. The element prevents the scraper or cleaning element from losing contact with the wall of the channel being cleaned, enhancing the drying action. The centering element is any shape that keeps the drying element in the relative center of the channel so that any lateral movement required to navigate through the channel (especially around a curve) does not cause the drying element to lie flat against the wall as it is advanced and thereby lose contact with the channel wall it is drying. In an exemplary embodiment, the cleaning element is located between 50% and 95% of the diameter of the channel being dried or cleaned. The centering element can be placed anywhere on the advancing element or the drying element, including multiple centering elements, to enhance and maintain drying and cleaning performance.

[0239] Example 1

[0240] The applicant has conducted many tests to compare the cleaning device disclosed in this article ( Figure 16-18 Venturi tagged in TM The various characteristics of the cleaner) are compared with the commercially available cleaning brush (Pull Thru manufactured by Cantel Medical) TM Cleaner) were compared. Pull Thru TMThe cleaner is designed with five cylindrical fins that are arranged very close to each other, with two of the fins grouped together, followed by a larger space, and then three additional fins grouped together. The fins are a flexible polymer overmolded over a harder strip of material and are used to propel the cleaner along the scope biopsy channel from the proximal end to the distal end of the scope while the scope is immersed in the cleaning fluid. The space between each set of fins is uniform, and the polymer between the fins is a thin, uniform thickness that is overmolded to adhere to the cylindrical monofilament.

[0241] Figure 16-18 The results of these tests are shown. In both cases, fluid was introduced into representative lumens of the endoscopic device and cleaning device 200, and the Pull Thru TM The cleaner was advanced through the lumen at comparable speeds (ie, approximately 30 cm / sec).Computational pressure flow modeling was performed to measure the positive pressure cleaning area of ​​both devices.

[0242] like Fig.16 As shown in the Pull Thru TM The cleaner 700 generates an average pressure of approximately zero (0) Pa between the proximal end 702 and the distal end 704 of each cleaning element 706. The cleaning device 200 disclosed herein (Venturi TM The Pull Thru generates an average pressure of about 36 Pa across the length of each cleaning element 300 between the cylindrical elements 302, 304. TM Compared to the cleaner 700, the cleaning / drying device 200 disclosed herein generates a significantly greater average pressure relative to the inner wall of the inner cavity. In addition, the cleaning device 200 disclosed herein has a peak pressure of more than 50Pa over a large portion of the cleaning element 300 (across the entire throat region 312), with a maximum pressure of 150Pa. In contrast, the Pull Thru TM The cleaner 700 has a peak pressure of over 50 Pa in a very small portion of the cleaning element 706 adjacent the end 704 and a maximum pressure of only 75 Pa. Thus, the peak pressure produced by the cleaning / drying device 200 disclosed herein is higher than that of the Pull Thru. TM Cleaner 700 is much taller and extends over a longer length of the device.

[0243] View now Fig.17 , Pull Thru TM The length of the cleaner 700 between the proximal end 702 and the distal end 704 is approximately 3.85 mm, while the average distance between the cylindrical elements 302, 304 of the cleaning / drying device 200 disclosed herein is approximately 9.25 mm. Peak Cleaning Pressure Coverage Area ("PPAC")TM ”) is considered to be the distance where there is a cleaning fluid or air pressure above 50Pa within each cleaning element. TM Cleaner 700 has a peak cleaning area of ​​approximately 0.58 mm or 1.5% of the total distance between ends 702, 704. In contrast, cleaning / drying device 200 disclosed herein has a peak cleaning area of ​​approximately 3.77 mm or 41% of the total distance between cylindrical elements 302, 304.

[0244] View now Fig.18 , Positive Pressure Clean Area (“+PAC TM ”) is defined as the distance along the cleaning / drying element where the cleaning fluid or air pressure relative to the inner wall of the inner cavity is positive or greater than zero. As shown, the Pull Thru TM Cleaner 700 has a +PAC of about 0.52 mm or 13.5% of the total distance between ends 702, 704. Cleaning device 200 disclosed herein has a +PAC of about 7.54 mm or about 81% of the length between cylindrical elements 302, 304. Thus, most of the area between cleaning / drying device 200 and the interior lumen wall has a positive cleaning pressure.

[0245] Example 2

[0246] Cleaning the internal channels of a duodenoscope or other endoscope is a critical manual cleaning step that must be performed as part of reprocessing a reusable endoscope to safely and effectively return the scope to service. FDA guidance for this portion of the overall reprocessing process involves testing actual scope channels or representative examples using a protein-based (preferably with blood) test. The preferred approach is to infuse the dirt into the channel, evenly distribute the dirt, and then allow the dirt to remain until dry, or until it reaches a worst-case time frame. Once in this state, a channel cleaner is passed through, flushing the channel at a level below that typically used as part of scope reprocessing, and then assessing the level of contamination.

[0247] The concentrated protein-based soil with added sheep blood was prepared by Mycoscience, an independent testing laboratory that prepared and administered the tests. The protein concentration was 19421 ug / cm2, which is on the high end of the range for duodenoscope channel contamination. A 4.2 mm x 180 cm PTFE duodenoscope channel was used for each test. 10 mL of soil was infused into the test channel, the ends of the channel were capped, and the channel was shaken and rotated back and forth to evenly distribute the soil within the test channel. The contaminated test channel was allowed to sit in the container for two hours with the ends capped to prevent migration of soil from the test channel. This is twice the one-hour time limit used by endoscope manufacturers as a worst-case scenario in their reprocessing testing.

[0248] After the two-hour period was over, the test channel was placed in a container filled with a non-enzymatic detergent at a concentration recommended for endoscope reprocessing. According to the endoscope manufacturer's reprocessing instructions, the endoscope test channel was immersed in the detergent, and the scope channel cleaner was then advanced through the test channel to clean the contaminated endoscope test channel. According to FDA guidelines, the flushing of detergent through the endoscope test channel was at a level substantially below the amount recommended by the endoscope manufacturer. Next, the endoscope test channel was extracted using 25 mL of extraction medium, and the residual protein count was determined.

[0249] The test is performed by TM Endoscope Channel Cleaner with Venturi TM Endoscope channel cleaner, and compared to a positive control test channel that was extracted without cleaning from the channel cleaner to confirm the contamination level. The positive control indicated a protein concentration level of 19421ug / cm2 for testing. In this test, Venturi TM The cleaner reduced contamination levels to .08 ug / cm2. The results for the pull-through cleaner were 162 percent higher, with the pull-through cleaner reducing contamination levels to .13 ug / cm2.

[0250] View now Fig.19 , a cleaning / drying device 100 according to another embodiment includes an elongated shaft 102 and a cleaning member 104 disposed on a portion of the shaft 102. The shaft 102 may include any suitable material that provides the shaft 102 with sufficient rigidity to be advanced through the lumen of an endoscope. The elongated shaft 102 has an outer diameter sized to fit within and translate through an internal lumen in the endoscope 10. In an exemplary embodiment, the shaft 102 will have an outer diameter ranging from about 0.5 to about 5 mm, preferably about 1 to 4 mm.

[0251] In certain embodiments, the device 100 includes a pull cord configured to retract or advance the elongated shaft 102 within the interior lumen of the endoscope 10. The device may also include an energy source and a motor for advancing and / or retracting the elongated shaft 102. Of course, it will be appreciated that the elongated shaft 102 may be manually translated through the interior lumen via a proximal handle or a suitable actuator (i.e., without a motor).

[0252] Clean / dry component 104 preferably comprises flexible material, and this flexible material is designed to be assembled in the internal lumen of endoscope or other endoscopic instrument, and absorbs or removes any debris or biological material in lumen.As shown, clean / dry component 104 has the outer diameter larger than the outer diameter of shaft 102, and is configured to contact the inner surface of lumen in endoscope or instrument.Clean / dry component 104 comprises the material that is configured to absorb tissue, biological material or other debris from at least a portion of the inner surface of lumen.Removing biological material, tissue or other debris and moisture eliminates a potential area for pathogen survival and growth in instrument.

[0253] Preferably, the cleaning / drying member 104 comprises a material that effectively absorbs biological matter, tissue or other debris and moisture from the internal surfaces of the instrument without causing defects such as scratches on these surfaces. This allows the instruments to be reused multiple times without gradually making them more difficult to clean and / or sterilize.

[0254] like Fig. 20 As shown in , preferably, the cleaning member 104 includes an expandable material that allows the cleaning member 104 to expand from a first position, in which the cleaning member 104 has an outer diameter that is smaller than the inner diameter of the lumen 50, to a second position, in which the cleaning member 104 has an outer diameter that is substantially equal to or larger than the inner diameter of the lumen 50. In this embodiment, the cleaning member 104 can be easily advanced through the lumen 50 and then expand to contact the interior surface 52 of the lumen 50 and absorb biological matter therefrom.

[0255] The cleaning / drying member 104 can be expanded by various means known to those skilled in the art. In an exemplary embodiment, the cleaning member 104 is configured to expand when absorbing fluid. In this embodiment, the cleaning member 104 can be advanced into the inner cavity in a relatively dry state, and then allowed to absorb the fluid therein, so that the cleaning / drying member 104 expands to a diameter equal to or greater than the inner diameter of the inner cavity.

[0256] Endoscopic instruments may often contain small tears, scratches, joints or other irregularities in the internal surface of the lumen (see Figure 3). Preferably, the cleaning / drying member 104 is configured to expand into these breaks and irregularities to contact the entire surface therein. In this way, the cleaning member 104 can absorb biological matter, fluid or tissue from within these small breaks, thereby removing significantly more biological matter from the instrument than conventional cleaning mechanisms.

[0257] Cleaning component 104 can comprise any material that absorbs biological matter, fluid or other debris, such as polymer, foam, sponge, bamboo, hemp, microfiber, cotton or other absorbable fabric etc.In one embodiment, cleaning component 104 comprises spongy material, such as cellulose, dry cellulose, natural cellulose and / or compressed cellulose.In an exemplary embodiment, material comprises the mixture of cellulose and compressed cellulose, and it allows sponge to expand when containing water.Preferably, material is selected to make sponge at least expand to the inner surface of inner cavity, keeps enough absorption capacity to absorb the material volume of the inner cavity segment volume that at least equals cleaning component 104 occupies simultaneously.

[0258] exist Fig.19 In the embodiment shown in , the cleaning / drying member 104 extends outwardly from one segment of the shaft 102 so that as the shaft 102 is advanced or retracted through the lumen, the cleaning / drying member 104 absorbs biological matter and moisture from the interior surface of the lumen. Alternatively, the cleaning / drying device 100 may include more than one cleaning / drying member 104 disposed on different segments of the elongated member (see Fig. 22 A). In an exemplary embodiment, the cleaning / drying components, alone or in combination, include a material configured to absorb a volume of material at least equal to the volume of the interior cavity.

[0259] In certain embodiments, the cleaning / drying device 100 further comprises a programmable motor (not shown), which may be part of or separate from the elongated shaft 102. The programmable motor is designed to withdraw the shaft 102 from the internal lumen of the endoscope 10 at a fixed or variable speed. Alternatively, the motor may be programmed with a specific algorithm corresponding to a specific cleaning or drying target. In one embodiment, the motor is programmed to withdraw the elongated shaft 102 at a fixed speed based on a predetermined cleaning or drying time required to completely absorb and remove biological matter from the internal lumen. In an alternative embodiment, the motor is programmed to withdraw the elongated shaft 102 in a series of discrete steps, i.e., the shaft is held in place for a specified period of time, and then withdrawn a specified distance and the step is repeated until it is withdrawn and the cleaning or drying procedure is completed.

[0260] In an embodiment, the elongated shaft 102 is advanced or retracted through the lumen of an endoscopic instrument, such as the biopsy channel 50 of the endoscope 10. The lumen may be filled or partially filled with a fluid, such as an enzymatic detergent or other cleaning fluid. The fluid is used to initially clean and / or disinfect the lumen to remove at least some of the biological matter and other pathogens from the lumen. In addition, the fluid may be absorbed by the sponge, causing the sponge to expand outwardly to the interior surface of the lumen. In a preferred embodiment, the sponge will expand to a diameter greater than the inner diameter of the lumen, so that the lumen at least partially constrains the sponge. This ensures that the sponge will expand into any cracks, breaches or other defects in the walls of the lumen, and provides sufficient pressure between the sponge and the inner wall of the lumen to allow the sponge to absorb and / or remove biological matter and fluid from the lumen as the elongated shaft 102 is advanced or retracted therethrough.

[0261] In one embodiment, the method includes measuring the volume of the inner chamber, and providing a cleaning / drying component configured to absorb a material amount at least equal to the volume. This ensures that the cleaning / drying component 104 absorbs all fluids, biological substances, tissues or other debris completely. The volume of the inner chamber can utilize a variety of different methods to measure. In an example, one of the ends of the inner chamber is sealed so that fluid cannot pass through the end, and the opposite end remains open. Then the fluid is delivered to the inner chamber until the inner chamber is fully filled (that is, any further fluid delivery causes fluid to overflow from the open end). Then the fluid is emptied into a suitable measuring container to determine the volume of the fluid occupying the inner chamber.

[0262] Once the volume of the target lumen has been measured, a cleaning / drying component 104 is provided, which has the ability to absorb at least the volume of fluid that will fill the lumen. This process can be determined by a variety of different methods. In an example, the cleaning / drying component 104 is completely dry so that it does not contain fluid substantially therein. Then dry cleaning components 104 or sponges are placed in a container that holds a large amount of fluid that has been measured. Allow cleaning components 104 to absorb fluid until it is fully saturated, and the difference in fluid volume in the container provides the maximum absorption capacity of cleaning components.

[0263] After the cleaning member 104 has passed through the entire lumen, air is injected into the lumen to purge any remaining disinfectant solution from the lumen and dry the lumen. Alcohol, such as 70% ethanol or isopropyl alcohol, may be delivered into the lumen to facilitate drying.

[0264] View now Fig. 21B, another embodiment will now be described. As shown, the cleaning / drying member 108 extends outwardly from the shaft 102 substantially along the entire length of the shaft 102, or at least along the entire length of the lumen of the endoscopic instrument. In this embodiment, the cleaning / drying member 104 has a length substantially equal to or greater than the length of the lumen to be cleaned and dried. Preferably, the cleaning / drying member 104 includes a material configured to absorb a volume of material at least equal to the internal volume of the lumen.

[0265] The cleaning / drying device 104 may also perform the function of centering the elongated shaft 102 within the interior lumen of the scope 10. Alternatively or in addition, the shaft 102 may also include a centering device (not shown) at its distal end to keep the cleaning / drying device 104 optimally positioned within the lumen so that the absorption of biological matter is substantially uniform throughout the lumen of the scope 10.

[0266] The cleaning device 100 may include one or more sensors (not shown) along the axis 102 for detecting biological substances, pathogens, liquids or other particulate matter in the endoscope 10 or other devices. Suitable sensors may include PCT and microarray-based sensors, optical sensors (e.g., bioluminescence and fluorescence), piezoelectric sensors, potentiometric sensors, amperometric sensors, conductivity sensors, nanosensors, etc. The axis 102 may also include indicators such as displays, which are connected to the sensors and are configured to indicate the presence of biological substances pathogens, liquids or other details detected by the sensors. The indicator may be any suitable chemical indicator verified for cleaning and / or sterilization processes, which undergoes physical or chemical changes visible to the human eye after being exposed to certain parameters. The indicator and sensor may be parts of the same device, or separated from each other.

[0267] According to another aspect, some embodiments may include the ability to infuse disinfectants, cleaning chemicals, or other fluids prior to or in conjunction with the absorption of biological matter by the cleaning member 104 to produce an additional bactericidal effect. The fluid may also be used to lubricate the lumen, making it easier to pull the elongated shaft 102 and cleaning member 104 through, or for other reasons, including leaving behind a chemical with a longer half-life to act as a bactericide, or other benefits.

[0268] View now Fig. 22 and 23 , another embodiment will be described. Fig. 22, the cleaning / drying device 200 includes an elongated shaft 202 and a cleaning / drying member 204 disposed at a distal end portion of the shaft 202. As with the previous embodiments, the shaft 202 may include any suitable material that provides the shaft 202 with sufficient rigidity to be advanced through the lumen of an endoscope. The elongated shaft 202 has an outer diameter sized to fit within and translate through an internal lumen in the endoscope 10. In an exemplary embodiment, the shaft 202 will have an outer diameter ranging from about 0.5 to about 5 mm, preferably about 1 to 4 mm.

[0269] The cleaning / drying component 204 has an outer diameter greater than the outer diameter of the shaft 202 and is configured to contact the inner surface of the lumen. The cleaning / drying component 204 includes a material configured to remove tissue, biological matter or other debris from at least a portion of the inner surface of the lumen. Removing biological matter, tissue or other debris and moisture eliminates a potential area for pathogens to live and grow within the device.

[0270] Preferably, the cleaning member 204 comprises a material having a defined roughness so that it effectively removes biological matter, tissue or other debris from the internal surfaces of the instrument without creating defects such as scratches on these surfaces. This allows the instruments to be reused multiple times without gradually making them more difficult to clean and / or sterilize.

[0271] The cleaning / drying component 204 includes an outer surface 210 that includes a sufficiently smooth material to minimize or completely avoid any scratches or other defects in the inner cavity surface of the endoscopic instrument. Conventional endoscopes and other endoscopic instruments typically include materials with high flexural strength, water resistance, and low coefficient of friction, such as PTFE, silicone, etc. Therefore, the outer surface 210 includes a material that will minimize scratching or otherwise damaging these materials, while still having sufficient hardness and / or roughness to clean biological matter, tissue, and other debris from the surface of these materials.

[0272] In the above-described embodiment, the cleaning / drying component 204 has a substantially annular cross-sectional shape, which is designed to conform to the circumferential shape of the internal lumen of the endoscopic instrument. However, it will be understood that the cleaning / drying component 204 can have a variety of different shapes and configurations. For example, the cleaning / drying component 204 can be rectangular, triangular, circular, oval, square, etc. In addition, the cleaning / drying component 204 can include surface disturbing objects, such as protrusions, bristles, barbs, rough areas, etc., to facilitate the cleaning / drying of the internal surface of the lumen. However, it will be understood that in an embodiment, any such disturbing objects or bristles can be designed from materials similar to the entire cleaning component, or designed from a variety of different materials.

[0273] In one embodiment, the cleaning / drying member 204 has an outer diameter greater than the outer diameter of the shaft 202 and is configured to contact the inner surface of the lumen. The cleaning / drying member 204 can extend outwardly from the distal portion of the shaft 202 so that as the shaft 202 is advanced or retracted through the lumen, the cleaning / drying member 204 removes biological matter from the inner surface of the lumen. Alternatively, as shown in FIG. Fig.24 As shown in , the device may include more than one cleaning / drying component 204 disposed on different portions of the shaft 202. In other embodiments, the cleaning / drying component 204 extends outwardly from the shaft 202 along substantially the entire length of the shaft 202, or at least along the entire length of the lumen of the endoscopic instrument.

[0274] All issued patents, published patent applications, and non-patent publications mentioned in this specification are hereby incorporated by reference in their entirety for all purposes to the same extent as if each individual issued patent, published patent application, or non-patent publication was specifically and individually indicated to be incorporated by reference.

[0275] Although several embodiments of the present specification are shown in the drawings, it is not intended that the present specification is limited thereto, because it is expected that the present specification is as wide in scope as the art allows, and the specification is read similarly. It will be understood by those skilled in the art that the devices and methods specifically described herein and shown in the drawings are non-limiting exemplary embodiments. The features shown or described in conjunction with an exemplary embodiment can be combined with the features of other embodiments. Those skilled in the art may conceive of various alternatives and modifications without departing from the present specification. Therefore, the present specification is intended to include all such alternatives, modifications and variations. Similarly, those skilled in the art will understand the additional features and advantages of the present specification based on the above-mentioned embodiments. Therefore, except as indicated in the appended claims, the present specification will not be limited by the content specifically shown and described.

Claims

1. A drying device, comprising: an elongated member configured to be advanced through a lumen of the device; at least one dry component coupled to a portion of the elongated member, wherein the dry component includes a distal end portion and a proximal end portion and a central portion between the distal end portion and the proximal end portion; and wherein the central portion is shaped to create a pressure gradient along the central portion from the distal end portion to the proximal end portion.

2. The drying device according to claim 1, wherein: As the drying element is advanced through the lumen, the pressure gradient causes an increase in relative velocity between the drying element and the fluid and air within the lumen.

3. The drying device according to claim 1, wherein: The pressure gradient causes an increase in shear stress between the fluid and air in the lumen and the inner wall of the lumen.

4. The drying device according to claim 1, wherein: The central portion of the drying component includes a contraction section connected to the proximal end portion, a diffusion section connected to the distal end portion, and a throat section connecting the diffusion section and the contraction section, wherein the throat section has a diameter that is smaller than the diameter of the proximal end portion and the distal end portion and larger than the diameter of the diffusion section and the contraction section.

5. The drying device according to claim 4, wherein: The converging section increases in diameter from the proximal end portion to the throat section and the diverging section decreases in diameter from the throat section to the distal end portion, and wherein the throat section is substantially cylindrical.

6. The drying device according to claim 4, wherein: The constriction section defines an angle of about 4 degrees to about 85 degrees with the throat portion.

7. The drying device according to claim 4, wherein: The constriction section defines an angle of about 15 degrees to about 30 degrees with the throat portion.

8. The drying device according to claim 4, wherein: The diverging section defines an angle of about 4 degrees to about 85 degrees with the throat portion.

9. The drying device according to claim 4, wherein: The diverging section defines an angle of about 15 degrees to about 30 degrees with the throat portion.

10. The drying device according to claim 1, wherein: The drying member is removably coupled to the elongated member.

11. The drying device according to claim 1, wherein: The dryer component has one or more centering elements positioned on either end of the dryer component for centering the dryer component as it is advanced through the lumen.

12. The drying device according to claim 1, wherein: The drying component includes first and second cylindrical centering elements positioned on either end of the drying component for centering the drying component as it is advanced through the lumen.

13. The drying device of claim 1, further comprising a second drying member coupled to the second portion of the elongated member and a third drying member coupled to the second drying member, wherein: The first drying component and the second drying component each include a distal end portion and a proximal end portion and a central portion therebetween, and wherein the central portion is shaped to generate a pressure gradient along the central portion from the distal end portion to the proximal end portion.

14. The drying device according to claim 13, wherein: The second drying component includes a distal end portion and a proximal end portion and a central portion therebetween, and 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.

15. The drying device according to claim 13, wherein: A proximal end portion of the second drying component is coupled to a distal end portion of the first drying component.

16. The drying device of claim 1, further comprising one or more cylindrical elements sized to contact a wall of the inner cavity, the one or more cylindrical elements positioned on the trailing ends of the first drying component and the second drying component.

17. The drying device according to claim 1, wherein: A distance between the proximal end portion and the distal end portion is about 1 to about 4 times the inner diameter of the lumen.

18. The device according to claim 1, wherein: The apparatus includes an endoscopic instrument.

19. The device according to claim 18, wherein: The endoscopic instrument includes an endoscope.

20. The device according to claim 1, wherein The device comprises a drinking straw for a beverage container.

21. The device according to claim 1, wherein The device includes tubing within a CPAP machine.

22. A drying device for use with an endoscopic instrument, the device comprising: an elongated member configured for translation through a lumen within the endoscopic instrument; at least one dry element coupled to a portion of the elongated member, wherein the dry element includes a distal end portion and a proximal end portion and a center portion therebetween, the center portion having an outer diameter smaller than the proximal and distal end portions; and Wherein the central portion is shaped to increase the force exerted by the fluid within the lumen against the inner wall of the lumen when the cleaning member is advanced through the lumen.

23. The drying device according to claim 22, wherein: The force generates a pressure of at least about 100 Pa in at least one region between the distal end portion and the proximal end portion of the cleaning element.

24. The drying device according to claim 22, wherein: The force generates a shear stress of at least about 5 Pa in at least one region between the distal end portion and the proximal end portion of the cleaning element.

25. The drying device according to claim 22, wherein: The force generates an average pressure of at least about 10 Pa between the proximal and distal end portions of the cleaning elements.

26. The drying device according to claim 22, wherein: The central portion has a distance and the force generates a pressure of at least 50 Pa in at least 25% of the distance between the proximal and distal end portions of the cleaning elements.

27. The drying device according to claim 22, wherein: The central portion has a distance, and the force generates a pressure greater than 0 Pa in at least 50% of the distance between the proximal end portion and the distal end portion of the cleaning element.

28. The drying device according to claim 22, wherein: The central portion of the drying component includes a contraction section connected to the proximal end portion, a diffusion section connected to the distal end portion, and a throat section connecting the diffusion section and the contraction section, wherein the throat section has a diameter that is smaller than the diameter of the proximal end portion and the distal end portion and larger than the diameter of the diffusion section and the contraction section.

29. The drying device according to claim 28, wherein: The converging section increases in diameter from the proximal end portion to the throat section, and the diverging section decreases in diameter from the throat section to the distal end portion.

30. The drying device according to claim 28, wherein: The constriction section defines an angle of about 4 degrees to about 85 degrees with the throat portion.

31. The drying device according to claim 28, wherein: The constriction section defines an angle of about 15 degrees to about 30 degrees with the throat portion.

32. The drying device according to claim 28, wherein: The diverging section defines an angle of about 4 degrees to about 85 degrees with the throat portion.

33. The drying device according to claim 28, wherein: The diverging section defines an angle of about 15 degrees to about 30 degrees with the throat portion.

34. A drying device for use with an endoscopic instrument, the device comprising: an elongated member configured for translation through a lumen within the endoscopic instrument; at least one dry element coupled to a portion of the elongated member, wherein the dry element comprises a distal end portion and a proximal end portion and a central portion between the distal end portion and the proximal end portion; and wherein the central portion includes a first segment connected to the proximal end portion, a second segment connected to the distal end portion, and a third segment connecting the first segment and the second segment, wherein the third segment has a diameter that is smaller than the diameters of the proximal end portion and the distal end portion and larger than the diameters of the first segment and the second segment.

35. The drying device according to claim 34, wherein: The first section tapers inwardly from the second section to the proximal end portion.

36. The drying device according to claim 34, wherein: The third section tapers inwardly from the second section to the distal end portion.

37. The drying device according to claim 34, wherein: The distal end portion includes a fin having a cylindrical element having a diameter substantially equal to or greater than an inner diameter of the lumen and a conical section tapering inwardly from the cylindrical element to the third section.

38. The drying device according to claim 37, wherein: The proximal end portion includes fins that taper outwardly in a distal direction.

39. The drying section of claim 34, wherein: The first segment defines an angle of about 15 degrees to about 30 degrees with the third segment.

40. The drying section of claim 34, wherein: The second segment defines an angle of about 15 degrees to about 30 degrees with the third segment.

41. A kit for cleaning and drying an endoscopic instrument, the kit comprising: A drying device, the drying device comprising: an advancement element configured for advancement through a lumen within the endoscopic instrument; and at least one drying component coupled to a portion of the advancement element, wherein at least a portion of the drying component is shaped and configured to substantially maintain contact with a wall of the lumen as the advancement element is advanced through the lumen; and a cleaning device comprising: an elongated member configured for advancement through the lumen within the endoscopic instrument; and At least one drying component connected to a portion of the second elongated component, wherein the cleaning component includes a distal end portion and a proximal end portion and a center portion between the distal end portion and the proximal end portion, and wherein the center portion is shaped to produce a pressure gradient along the center portion from the distal end portion to the proximal end portion.

42. The kit of claim 41, wherein: The drying component includes a distal end portion and a proximal end portion and a central portion therebetween, and 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.

43. The kit of claim 41, wherein: The drying member includes one or more substantially cylindrical members spaced apart from one another along the advancing member.

44. The kit of claim 41, wherein: The cylindrical member includes an absorbent material.

45. The kit of claim 41, wherein: The cylindrical components include a first cylindrical component having a first diameter and a second cylindrical component having a second diameter, wherein the first diameter is greater than the second diameter.

46. ​​The kit of claim 41, wherein: The propulsion element comprises a filament, a wire or a tube.

47. The kit of claim 41, wherein: The drying device further includes a centering element configured to center the drying component within the inner cavity.

48. The kit of claim 41, wherein: The drying device is sterilized.

49. A method for drying one or more lumens within an endoscopic instrument, the method comprising: advancing an elongated member through the lumen within the endoscopic instrument, wherein the elongated member includes at least one dry member; and A pressure gradient is created along the central portion of the drying element.

50. The method of claim 49, wherein: As the drying element is advanced through the lumen, the pressure gradient causes an increase in relative velocity between the drying element and the fluid within the lumen.

51. The method of claim 49, wherein: The pressure gradient causes an increase in shear stress between the fluid in the lumen and the inner wall of the lumen.

52. The method of claim 49, wherein: The central portion of the drying component includes a contraction section connected to a proximal end portion, a diffusion section connected to a distal end portion, and a throat section connecting the diffusion section and the contraction section, wherein the throat section has a diameter that is smaller than the diameter of the proximal end portion and the distal end portion and larger than the diameter of the diffusion section and the contraction section.

53. The method of claim 49, further comprising centering the drying component within the lumen as the drying component is advanced through the lumen.

54. A kit, comprising: a beverage container, the beverage container including a drinking straw; as well as an elongated member configured to be advanced through an interior lumen of the drinking straw; at least one cleaning member coupled to a portion of the elongated member, wherein the cleaning member includes a distal end portion and a proximal end portion and a central portion between the distal end portion and the proximal end portion; and 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.

55. The kit of claim 54, wherein: As the cleaning member is advanced through the lumen, the pressure gradient causes an increase in relative velocity between the cleaning member and the fluid and air within the lumen.

56. The kit of claim 54, wherein: The pressure gradient causes an increase in shear stress between the fluid and air in the lumen and the inner wall of the lumen.

57. The kit of claim 54, wherein: The central portion of the cleaning member includes 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 section and the contraction section, wherein the throat section has a diameter that is smaller than the diameters of the proximal and distal end portions and larger than the diameters of the diffusion section and the contraction section.

58. The kit of claim 57, wherein: The converging section increases in diameter from the proximal end portion to the throat section and the diverging section decreases in diameter from the throat section to the distal end portion, and wherein the throat section is substantially cylindrical.

59. The kit of claim 54, wherein: The cleaning device also includes a tip element having a substantially cylindrical shape and sized to be advanced through the lumen of the drinking straw.

60. A cleaning device for a beverage container, the cleaning device comprising: an elongated member configured to be advanced through an interior cavity of the beverage container; at least one cleaning member coupled to a portion of the elongated member, wherein the cleaning member includes a distal end portion and a proximal end portion and a central portion between the distal end portion and the proximal end portion; and 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.

61. The cleaning device of claim 60, wherein: As the cleaning member is advanced through the lumen, the pressure gradient causes an increase in relative velocity between the cleaning member and the fluid and air within the lumen.

62. The cleaning device of claim 60, wherein: The pressure gradient causes an increase in shear stress between the fluid and air in the lumen and the inner wall of the lumen.

63. The cleaning device of claim 60, wherein: The central portion of the cleaning member includes 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 section and the contraction section, wherein the throat section has a diameter that is smaller than the diameters of the proximal and distal end portions and larger than the diameters of the diffusion section and the contraction section.

64. The cleaning device of claim 63, wherein: The converging section increases in diameter from the proximal end portion to the throat section and the diverging section decreases in diameter from the throat section to the distal end portion, and wherein the throat section is substantially cylindrical.

65. The cleaning device of claim 63, wherein: The constriction section defines an angle of about 4 degrees to about 85 degrees with the throat portion.

66. The cleaning device of claim 63, wherein: The constriction section defines an angle of about 15 degrees to about 30 degrees with the throat portion.

67. The cleaning device of claim 63, wherein: The diverging section defines an angle of about 4 degrees to about 85 degrees with the throat portion.

68. The cleaning device of claim 63, wherein: The diverging section defines an angle of about 15 degrees to about 30 degrees with the throat portion.

69. The cleaning device of claim 60, wherein: The cleaning member has one or more centering elements positioned on either end of the cleaning member for centering the cleaning member as it is advanced through the lumen.

70. The cleaning device of claim 60, wherein: The cleaning member includes first and second cylindrical centering elements positioned on either end of the cleaning member for centering the cleaning member as it is advanced through the lumen.

71. The cleaning device of claim 60, further comprising a second cleaning member coupled to the second portion of the elongated member and a third cleaning member coupled to the second cleaning member, wherein: The first cleaning member and the second cleaning member each include a distal end portion and a proximal end portion and a central portion therebetween, and 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.

72. The cleaning device of claim 71, wherein: A proximal end portion of the second cleaning member is coupled to a distal end portion of the first cleaning member.

73. The cleaning device of claim 71, further comprising one or more cylindrical elements sized to contact a wall of the lumen, the one or more cylindrical elements positioned on trailing ends of the first and second cleaning members.

74. The cleaning device of claim 60, wherein: A distance between the proximal end portion and the distal end portion is about 1 to about 4 times the inner diameter of the lumen.

75. The cleaning device of claim 60, wherein: The cleaning device also includes a tip element having a substantially cylindrical shape and sized to be advanced through the lumen of a drinking straw.

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