System and method for a drying and / or cleaning device

Abstract

Provided are devices and methods for cleaning and / or drying devices such as drinking straws for beverage containers, medical devices, and endoscopic instruments. A drying device for use in combination with an endoscopic instrument includes an elongate member configured to advance 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 the hydrodynamic fluid friction and fluid pressure imparted to the wall of the internal lumen of the endoscope to more effectively remove all moisture and fluid from the inner surface of the endoscopic instrument.

Description

Technical Field

[0001] The present invention relates to systems and methods for drying and / or cleaning devices.

Cross - reference to Related Applications

Background Art

[0002] Endoscopes are used and reprocessed daily to deliver very high - level optical performance, consistent real - time image transmission, predictable scope handling, and other functions important for the successful diagnosis and treatment of clinical conditions. This also occurs in non - medical uses related to inspection, cleaning, and repair of remote locations using non - medical endoscopes. This includes, by way of example and not limitation, other non - medical uses related to hydraulic lines, oilfield pipelines, refinery lines and lumens, sewer and water lines, internal areas of combustion engines, and remote visualization of areas that benefit from remote access and evaluation, including areas such as hydraulic lines, oilfield pipelines, refinery lines and lumens, sewer and water lines, internal areas of combustion engines, and other non - medical uses related to remote visualization of areas that benefit from remote access and evaluation.

[0003] Endoscopes are high - tech instruments typically having advanced and expensive optical chips at the distal end of the scope to facilitate excellent visualization. These image signals are captured on the chip and then communicated through high - definition image transmission technology involving sophisticated software and image - processing hardware that processes the optical signals. These signals are then converted through software and processors and projected at multiple frames per second to an image screen, console, or other means of transmitting the image to a user remote from the optical chip.

[0004] The excellent imaging capabilities of endoscopes have enabled many advancements in the medical and non-medical fields. This is due in large part to the combination of excellent optical performance and scope handling, coupled with the reusability of almost all endoscopes. This powerful combination allows for high-quality optical components to be made available at a reasonable cost per use, due to the ability to clean, disinfect (when applicable), and reuse endoscopes with advanced optical capabilities. The ability to reuse these scopes substantially distributes the high cost of endoscope functionality over multiple procedures / uses, thereby enabling reasonable low-cost access to state-of-the-art technology for multiple beneficial uses worldwide. Endoscopes with these advanced optical capabilities are too expensive to use once and discard. In addition, the environmental impact of discarding the advanced electronics that facilitate endoscope functionality cannot be ignored, is inappropriate, and is not safe for the environment. Reusable scopes provide a way to make maximum optical functionality available for various procedures that otherwise could not afford the cost of using such technology.

[0005] While reusable scopes have provided significant advancements and functionality, there are recent concerns regarding their ability to consistently and predictably clean, thereby removing all contaminants and biological materials that can contaminate the endoscope during use. A successful cleaning step is an important step in supporting disinfection and / or sterilization (when applicable) to reprocess these scopes for their next use. The cleaning step for non-medical scopes is also important to avoid the next use of the scope being inhibited by retention materials that can accumulate and negatively impact scope performance. This applies to both non-robotic scopes and scopes that are connected to robotic technology or otherwise used in conjunction with it to observe, navigate, and, when applicable, treat using remote visualization.

[0006] Multiple contamination-related reprocessing problems leading to potential patient infections and / or endoscope performance issues have been identified with these endoscopes. These include the cleanliness of reusable valves used to facilitate aspiration and air / water insufflation, the presence of residual material that cannot be consistently removed from the composite distal ends of certain endoscopes (particularly duodenoscopes and endoscopic ultrasounds), and concerns regarding the successful cleaning of long biopsy / working channels within certain endoscopes that are important for passing instruments to the distal end of the endoscope.

[0007] Nearly all of these problems can be addressed through the use of new and relatively low-cost technologies and practices that were developed in response to these concerns, are applicable in the context of current workflows and procedures, and are environmentally friendly, particularly when compared to single-use endoscope options. These relatively low-cost technologies and practices include the use of single-use disposable tubing and valves instead of reusable tubing and valves, the use of sterile single-use endoscope shields that seal the area of the composite distal end of the endoscope during use and initial pre-cleaning instead of leaving the area open and exposed to contamination, the use of forced air drying, improved compliance with reprocessing techniques, and the implementation of post-procedure culturing and monitoring to address other areas of concern.

[0008] With all of these advancements, the remaining area to be addressed is the cleaning of the internal lumen of the endoscope. During a medical procedure, the internal biopsy and suction channels become heavily contaminated with bacteria, biological material, and debris through the passage of multiple instruments through the biopsy channel and through the actuation of suction to remove mucus, debris, and other substances that may obstruct the physician's visualization during the procedure. All of these activities provide a benefit to the patient by delivering treatment in a minimally invasive manner through the endoscope. However, in parallel with these beneficial activities, the endoscope is subject to heavy contamination of these channels, which then must be substantially cleaned and returned to its original state in order to be used on the next patient (or for non-medical use) without exposing the next patient (or non-medical use) to the risk of endoscope-related infection (or performance degradation, unclean non-medical endoscope). It is known that without successful cleaning, the endoscope cannot be successfully disinfected or sterilized. Biological material and debris that are not removed act as a shield for pathogens, protecting them from death by disinfectants and sterilants used to reprocess the endoscope. In addition to this, biological material and pathogens that are not removed create an opportunity for microorganisms to attach to the inner surfaces of the endoscope and become involved in replication to form a biofilm, which makes the removal of these microorganisms particularly difficult and which then generates the risk of transmission of multi-drug resistant infections through the endoscope. The biofilm can replicate, detach, and then attach to a new location and repeat this process, while also incorporating other microorganisms into the biofilm during this process and generating additional multi-drug resistant organisms (MDROs) that are substantially untreatable with antibiotics. MDRO infections are particularly dangerous and have resulted in numerous deaths worldwide from contaminated endoscopes that were not successfully reprocessed.

[0009] In the current Covid-19 pandemic, the importance of successful cleaning has become even more prominent. Covid-19 infections begin in the lungs but rapidly migrate to the gastrointestinal tract, and it is now well-established that viral replication occurs in these organs before detectable symptoms appear. A significant number of endoscopic procedures, by way of example and not limitation, involve the use of endoscopes to examine and treat lung pathologies (e.g., bronchoscopy using a special endoscope called a bronchoscope) and to diagnose and treat gastrointestinal pathologies (e.g., the use of gastroscopes, duodenoscopes, endoscopic ultrasounds, and colonoscopes). The Covid-19 virus can become encapsulated in biofilms resulting from incomplete cleaning of the endoscope, potentially leading to the progression to drug-resistant strains of Covid-19 that can then infect subsequent patients. Given all of these concerns, there is a need for new technological innovations that significantly improve the effectiveness and predictability of successful cleaning of the lumen of the endoscope.

[0010] Current cleaning practices and technologies Current endoscope channel cleaning practices utilize certain cleaning techniques that increase variability and may potentially have an adverse effect on the success of the stage of cleaning the endoscope channel. The most commonly used cleaning method involves passing a nylon wire bristle brush on the end of a long push / pull element into the proximal end of the biopsy channel of the endoscope. The wire brush is inserted at the biopsy port at the proximal end of the scope, advanced down the biopsy channel to the distal end of the scope, and repeated in the same manner for other internal channels. This action must be performed while the scope is submerged in a cleaning fluid, with the intention that the mechanical action of the wire bristles to remove biological material and debris occurs after the scope has been immersed in the cleaning fluid.

[0011] As a result of this activity, after the wire bristle brush is immersed at the distal end of the biopsy channel, the individual performing the cleaning inspects the brush for any visible signs of debris and, if any debris is noticed, repeats this activity until no visible debris remains on the brush. The goal of this series of actions is to remove all visible debris and biological material from the internal channel within the scope through the mechanical action of the brush. Brushing is performed after the scope, which is intended to loosen contaminants prior to passing the brush through it, is immersed in the cleaning fluid for a short period of time.

[0012] Limitations of current methods Current endoscopic channel cleaning techniques have several significant limitations that increase the variability of cleaning results and have an overall adverse impact on the success of the stage of cleaning the endoscopic channel. The first problem is that current cleaning techniques involve advancing the cleaning brush from the proximal end of the scope down the channel through the opening of the biopsy channel to the distal end of the scope where the instrument exits the scope into the patient's body. This technique means that any biological material, 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 be cleaned, to the distal tip of the scope, which is the most complex part of the scope to be successfully cleaned and reprocessed and is the area linked to most scope-related infections and deaths. In essence, the cleaning brush not only partially removes debris within the channel but also acts as a tool to scrape or push contaminants from the biopsy channel into the area of the scope that is the most difficult to clean and has the highest risk of scope-related infection. Logically, it would be desirable to do everything possible to perform the opposite of what is currently done with respect to the direction for passing the cleaning brush through the biopsy channel and the suction channel (i.e., passing it from the distal end of the biopsy channel to the proximal end exit). This current technique using the brush, not limited as an example, is also performed with certain complex scopes such as duodenoscopes due to limitations in the current art that result in problems such as the composite distal end of the scope becoming immobile at the distal end and unable to advance to clean the biopsy / working channel of the scope from there.

[0013] In addition to this limitation, the cleaning brush itself has several significant limitations that impede the success of consistent and repeatable scope reprocessing. Photographs of the interior of the scope biopsy channel after the cleaning step using a nylon wire bristle brush reveal that the bristles flex as they are passed through the channel, leaving streaks along the interior of the channel rather than a clean and consistent cleaning result. These channels can also be heavily contaminated by debris, mucus, and other biological materials from the operation of suction to remove debris, mucus, and other biological materials during the procedure, as well as from the repeated passage of treatment instruments during the procedure. Using a brush that flexes and causes streaks means that the channel cleaning will be incomplete and highly variable. In addition, attempts to offset this limitation through the use of repeated nylon wire bristle brush passes recommended by scope manufacturers do not solve this problem and do not result in a predictable and completely clean channel. Instead, a combination of repeated passes using a rigid bristle brush causes damage to the surface of the internal endoscope channel because the bristles produce scratches and tears from the effects of multiple wire passes. These scratches and tears allow bacteria and biological materials to enter and settle in these new spaces despite multiple brush passes to clean the scope after the next procedure, limiting the consistency of the cleaning results and thereby inhibiting the function of disinfectants and sterilants that successfully disinfect and sterilize the scope to safely return it to its original state for use in the next procedure. All biological materials and debris must be successfully removed for the successful disinfection and reprocessing of the scope. Residual biological materials and debris act as a shield over pathogens (including bacteria that naturally occur from patients) that may settle within these channels, preventing the successful treatment of the scope with disinfectants and sterilants that kill the pathogens and make the scope safe for reuse by the next patient.

[0014] In connection with this situation, the person responsible for cleaning the viewing lens is assumed to be involved in the repeated passage of the wire bristle brush. The handling instructions from the viewing lens manufacturer direct the individual cleaning the viewing lens to pass the wire bristle brush through until no visible debris remains. However, given the deflection of the bristles, the absence of visible debris is not conclusive evidence that the passage of the brush has resulted in a successful cleaning. In addition, it is not clear that all individuals involved in cleaning with a wire bristle brush are always involved in repeated brush passages (in addition, visual inspections are not completely accurate). A device that can substantially and in one pass clean the biopsy channel is considered a significant way to remedy these problems.

[0015] An additional problem relates to instrument damage to the biopsy channel through improper instrument passage. The biopsy channel is typically manufactured from PTFE or other polymeric materials. It is designed to allow for the predictable passage of instruments and to have a low coefficient of friction to typically assist in instrument passage. The channel is compatible with a wide range of instruments, and the diameter of the instrument being passed is significantly smaller than the diameter of the biopsy / working channel of the endoscope, providing space for the safe advancement of the instrument through the channel. However, sometimes instruments are not properly used, such as attempting to open biopsy forceps within the biopsy channel or pulling the biopsy forceps back through the channel with the forceps not properly closed. When this occurs, scratches, depressions, or tears can be introduced into the biopsy channel, which in turn increases the difficulty of achieving successful removal of expected biological material and debris when cleaning the biopsy channel. There is no evidence that wire bristle brushes can remove debris from biopsy channel damage in a predictable and consistent manner. Data recently released from a national survey indicates that in the case of two complex specialty endoscopes, duodenoscopes and endoscopic ultrasounds, in up to 15% of cases, cleaning of the biopsy channel by current methods failed to remove biological material and debris.

[0016] Alternative techniques to nylon wire bristle brushes are pull-through brush cleaners such as the Pull Thru® cleaners manufactured for Cantel Medical. The pull-through brush cleaner has five cylindrical fins arranged very close to each other, with two of the fins forming a mass with each other, followed by a larger space, and then three additional fins designed to form a mass with each other. The fins are a flexible polymer overmolded onto a rod of a harder material used to advance the cleaner down the biopsy channel of the scope from the proximal end to the distal end while the scope is submerged in the cleaning fluid. The space between each mass of fins is uniform, and the polymer between the fins is thin and of uniform thickness overmolded to adhere to the cylindrical monofilament. The advantage of the pull-through cleaner is that it causes less trauma to the wall of the biopsy channel compared to wire brush cleaners. There is also some evidence that the pull-through cleaner can more substantially remove biological material from a contaminated biopsy channel.

[0017] However, pull-through cleaning brushes have several drawbacks. Similar to wire bristle brushes, pull-through cleaning brushes are designed to pull debris from the proximal end of the endoscope's biopsy channel to the distal end, where cleaning is difficult and high-risk, increasing the potential for contamination at the distal end when attempting to clean the endoscope's biopsy channel. An additional limitation associated with these devices is that the cylindrical fins are significantly oversized compared to the diameter of the biopsy channel, resulting in significant deflection at the ends of the fins, creating a buckling effect that produces 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 is moved through the biopsy channel. In addition, this gap means that surface changes in the wall of the biopsy channel, such as scratches or tears resulting from passage of the instrument, are less likely to be addressed by the pull-through brush when it is moved through the biopsy channel. The fins cannot affect scratches and tears when the fins pass over damage to the channel wall.

[0018] An additional limitation present with all technologies used to clean the internal lumen of an endoscope is the lack of cooperative or complementary elements between the two technologies used in the cleaning phase. All reusable endoscope manufacturers require placing the endoscope in a fluid formulated to assist in the removal of biological material and debris as a first step in the cleaning process, followed by a second step of brushing the internal channels while the endoscope is submerged in the cleaning fluid. There are multiple formulations for the cleaning fluid, but the most commonly used are either an enzyme cleaner or a pH-neutral non-enzyme cleaner. These cleaners are intended to loosen the attachment of biological material and bacteria to the walls of the channel, but there is evidence that they are ineffective on their own and that, even with brushing, not all biological material is consistently removed.

[0019] One of the significant limitations of this current approach is that while the cleaning fluid and brushing application are independent technologies that are used together (i.e., the scope is submerged in the cleaning fluid while the channel is being brushed), these technologies are not designed to actively complement each other and enhance each other's effects. There is a need for new technological innovations that address the significant limitations of current brushing techniques and can actively complement and cooperate with the cleaning fluid used in this important cleaning stage for reusable endoscopes. There is a need for new technological innovations that address these significant limitations and ensure predictable and consistent cleaning of the biopsy and aspiration channels and other lumens (when applicable) of reusable endoscopes.

[0020] Current drying practices and technologies Another important need not satisfied in the above-described instruments and processes is the downstream problem associated with drying the instrument after the cleaning and / or disinfection or sterilization process has been completed. Most, if not all, disinfection or sterilization methods involve some delivery element of a liquid or gas of the disinfectant or sterilant, and in most protocols, this is followed by rinsing with a chemical such as water or sterile water or, in very limited cases, evaporation of the chemical.

[0021] In all of these processes, the critical final stage after disinfection or sterilization is the drying stage of the instrument. With respect to the outer surface of the medical device, the aspects of this process are somewhat straightforward, but with respect to recessed areas, particularly those that are relatively narrow and sometimes long channels, drying these areas is difficult, time-consuming, and unpredictable or inconsistent. Substantial drying failure negates the advantages of the overall reprocessing approach, including the disinfection stage and / or the sterilization stage. This is because wet surfaces promote the growth of pathogens and biofilms. Pathogens and biofilms cannot grow when the instrument is dry. Hydrates are a central factor in the growth of pathogens and biofilms, leading to nosocomial infections, drug-resistant infections, and other deadly infections. In non-medical applications, residual hydrates affect the performance of the device and can ultimately expose the user to the growth of biofilms and pathogens that may even pose a risk of exposure to one or more pathogens.

[0022] Current drying techniques have applied some inconsistent and variable methods that do not provide a consistent assurance that the moisture within the channels and recessed areas described above is removed and thus that the remote and / or recessed areas are dry. Attempts to simply hang the device vertically so that the wet channels are positioned such that the water inside the channels eventually runs down and evaporates due to the effect of gravity have been made without producing good results. This technique has been shown to be false by evidence that these channels do not consistently dry completely, even after several days in this position.

[0023] In an attempt to address these issues, there have been attempts to flush these channels with alcohol, on the premise that alcohol can accelerate drying and act as an auxiliary bacteriostatic agent (although the medical devices are already disinfected or sterilized at this point). Data has shown that this attempt does not clearly accelerate the drying time or drying effect, and in certain cases, may rather extend the time of the drying process. In addition to this, there are concerns that using alcohol may lodge certain bacteria and pathogens that are otherwise inert or harmless within the channels, and that these bacteria and pathogens may be transmissible to patients or users.

[0024] Other techniques include those that use air drying, but this technique is inherently difficult and time-consuming due to the channels that need to be dried being recessed and sometimes elongated, and is variable. Some of these channels are 4 to 6 feet in length and have a diameter of only a few millimeters or less. Drying techniques include sending compressed air into or through the channels to enhance drying or suspending the device in a cabinet where air circulates using a motor-driven fan that blows air into a small space. These techniques include a specific technique called "forced air drying" where air blown through a pipe system into a confined area such as an endoscope channel is filtered by a motor-driven fan. Even these more aggressive and targeted techniques have variable results, at least in part due to the distance the air must travel to dry the channels, the possibility of changes in channel diameter that affect air velocity, and the surface tension of the water that is more effective than the air force at various points and impedes timely water removal. In addition, confined spaces inherently help trap or retain water, promote a moist environment, and inhibit evaporation. There are further challenges that go beyond these significant difficulties, including endoscopes and other devices with curved internal channels, where in this case, Y-junctions and connectors where one or more channels come together and water can accumulate, and more varied surfaces such as areas adjacent to and / or outside valves that interact with the channels are created. Summary of the Invention Problems to be Solved by the Invention

[0025] Accordingly, it is desirable to provide an improved system and method for cleaning biological material from endoscopic instruments such as endoscopes and other instruments having remote channels and lumens, and then drying these endoscopes after cleaning so that the channels and lumens can be substantially sterilized or disinfected. In particular, it is desirable to provide a device that can substantially clean and / or dry all inner surfaces of endoscopic technology, including crevices, Y-junctions, and scratches or other irregularities, without further damaging them.

Means for Solving the Problems

[0026] Provided are devices and methods for cleaning biological material, tissue, or other debris from endoscopic instruments such as endoscopes, particularly from internal lumens or other spaces within the endoscopic instrument. Also provided are devices and methods for drying these internal lumens after cleaning them, and further devices and methods for performing tests to confirm the success of cleaning and drying. The methods and devices disclosed herein can be used in or incorporated into a variety of different reusable or disposable endoscopic instruments and endoscopic devices, including internal lumens or other internal spaces such as endoscopes, trocars, cannulas, dilation devices, Foley catheters and other indwelling catheters, guidewires, central venous catheters, bipolar or monopolar electrosurgical devices or ultrasonic devices, arterial lines, drainage catheters, peripherally inserted central catheters, endotracheal tubes, feeding tubes, lung ventilators, dialysis devices, continuous positive airway pressure (CPAP) devices, perfusion devices, infusion pumps, ventilators, robotic and non-robotic surgical devices, and other devices for deployment, penetration, and / or guidance into the body. The dimensions of the cleaning and drying devices disclosed herein are, of course, considered to be adjusted to fit the size of a particular instrument or device.

[0027] 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, head gears, filters, humidifiers, masks, and / or air entrainment valves, flow-dependent resistance devices, pneumatically actuated air sources, and venturi flow drivers.

[0028] The methods and devices disclosed herein can be used to clean and / or dry drinking vessels and their components, such as drinking straws, beverage containers, water containers, bottles, thermoses, syringes, water pitchers, glass bottles, baby bottles, water flasks, and insulated beverage containers, and the inner surfaces of drinking straws for any of these containers. For example, the devices described herein can be used to clean and / or dry the inner surface of a drinking straw from a water flask and / or the water flask itself. In some cases, the devices disclosed herein are incorporated as a kit within these beverage containers.

[0029] The technological innovations of the present disclosure address a number of limitations associated with current methods for cleaning and / or drying lumens or channels and provide new and important capabilities for enhancing cleaning and drying performance. In some embodiments, the devices disclosed herein address significant drawbacks associated with current channel cleaning methods for endoscopes where a brush and cleaning fluid do not cooperate and are not designed to complement the performance of each other's technology. These technological innovations not only address current problems associated with brushes but also complement and improve the effectiveness of the cleaning fluid used in endoscope channels. In addition, certain embodiments provide the advantage of being able to clean the lumen of an endoscopic instrument without creating defects in the inner surface of the lumen. This allows the instrument to be cleaned multiple times without extending the life of the instrument and without providing another area for biological material, pathogens, or other debris to settle. In certain embodiments, these technological innovations provide a device that can rapidly and consistently dry the internal lumen or internal channel of an endoscopic instrument.

[0030] In one embodiment, a drying device for use in an endoscopic instrument includes an elongate member configured to advance through a lumen within the endoscopic instrument and a drying element coupled to at least a portion of the elongate member. The drying element includes a certain portion having an outer diameter equal to or larger than the outer diameter of the elongate member.

[0031] In an embodiment, the elongate member includes an attachable push-and-pull element, such as a navigation element, that can be advanced from the proximal end of an internal lumen of the endoscopic instrument, such as a biopsy channel on the endoscope, through the biopsy channel and out of the distal end of the biopsy channel to connect to the drying element. In certain embodiments, the drying element can be removably attached to the distal end portion of the advancing element or navigation element. In other embodiments, the drying element is permanently attached to the navigation element. These embodiments enable the drying element to be translated from the distal end to the proximal end of the scope lumen or vice versa.

[0032] In one embodiment, the drying member includes a distal end portion and a proximal end portion having a diameter substantially equal to or larger than the inner diameter of the lumen, and a variable pressure central portion between these distal and proximal end portions. Alternatively, the proximal end portion and the distal end portion can have a diameter substantially smaller than the inner diameter of the lumen. The variable pressure central portion is shaped to create a pressure gradient as it descends from the distal end portion to the proximal end portion to generate a pressure gradient. This pressure gradient provides an increase in the relative velocity between the drying member and any air or fluid within the lumen when advancing the drying member through the lumen. The high velocity of the air / fluid enhances the shear stress between the air or fluid and the lumen wall, thereby generating a stronger force for drying the wall.

[0033] In certain embodiments, the drying device is sterilized or disinfected such that the sterilized and / or disinfected device channels are not compromised by the drying process. Conversely, when passing this drying device through an already sterilized or disinfected device channel, water and moisture are removed without changing or contaminating the state of the sterilized or disinfected device channel.

[0034] In embodiments, the proximal and distal portions of the drying member create a consistent circumferential contact with the inner wall of an endoscopic 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 with at least one portion thereof having a diameter approximately equal to or slightly larger than the diameter of the inner lumen. In an exemplary embodiment, the diameters of the proximal and distal portions are from about 1 to about 1.5 times, preferably about 1.25 times, the diameter of the inner lumen. This avoids deflection of the proximal and distal portions, thereby reducing buckling and the creation of gaps between the drying element and the inner wall of the lumen.

[0035] The variable pressure central portion is designed to generate a variable pressure between the two circumferential contact elements and the wall of the channel being cleaned. Thus, when advancing the drying member through the channel, scope, and inside of the channel, i.e., moving the drying element through the lumen, the variable pressure design between the two circumferential elements generates either a vortex, a Venturi effect, an inverse Venturi effect or an anti-Venturi effect, or any other variable pressure between the drying element and the wall of the endoscopic channel.

[0036] In certain embodiments, the central portion of the drying member includes a constriction section coupled to the proximal portion, a diffuser section coupled to the distal portion, and a throat section coupling the diffuser section and the constriction section. The throat section has a diameter smaller than the diameters of the proximal and distal portions and larger than the diameters of the diffuser and constriction sections.

[0037] The variable pressure region between the two cylindrical elements can include an inverse partial Venturi shape, a parabolic shape, a variable slope shape, or other shapes that generate a variable pressure or vortex between the two cylinders and the wall of the channel to be dried, thereby increasing the force on the channel wall when advancing the drying member. In an exemplary embodiment, the throat section is substantially cylindrical. The converging section preferably has an increasing diameter from the proximal end portion to the throat section, and the diverging section preferably has a decreasing diameter from the throat section to the distal end portion, thereby generating a vortex, a Venturi effect, an inverse Venturi effect, or a counter Venturi effect, or other variable pressure between the distal end portion and the proximal end portion of the drying element.

[0038] The inclination angle of the converging section may vary depending on the diameter of the channel to be dried and other factors and must be sufficient to facilitate the variable pressure flow between the cylinders when advancing the drying element. In certain embodiments, the converging section defines an angle between the proximal end portion and from about 4 degrees to about 85 degrees, preferably from about 15 degrees to about 30 degrees. Similarly, the diverging section defines an angle between the distal end portion and from about 4 degrees to about 85 degrees, preferably from about 15 degrees to about 30 degrees. In other embodiments, the converging section can have an inclination shape greater than 1, a curved shape, a variable shape, or other shapes that assist in varying the pressure between the two cylindrical elements.

[0039] Similarly, the angles between the converging and diverging sections and the throat section may vary depending on the diameter of the channel to be dried and other factors and must be sufficient to facilitate the variable pressure between the cylinders when advancing the drying element. In certain embodiments, this angle is from about 10 degrees to about 50 degrees, preferably from about 15 degrees to about 30 degrees, more preferably from about 20 degrees to about 25 degrees.

[0040] The length and diameter of each section of the variable pressure region are preferably selected to optimize the vortex, Venturi effect, inverse Venturi effect or anti-Venturi effect, or other variable pressures, 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 section can be from about 2 mm to 10 mm, preferably from about 3 mm to 5 mm, more preferably about 4 mm. The diameter of the throat section will also depend on the diameter of the internal lumen, as well as the diameters of the constriction and diffusion sections. In certain embodiments, the throat section is smaller in diameter than the internal lumen, but greater than 50% of the lumen diameter, preferably greater than about 60% of the lumen diameter, more preferably equal to or greater than about 70% of the lumen diameter.

[0041] When advancing the drying element through the lumen, the variable pressure region of the drying element is configured to generate a pressure against the inner wall of the lumen. In certain embodiments, the variable pressure region is configured to generate a peak pressure of at least about 75 Pa within at least one region between the distal and proximal end portions of the drying element. This peak pressure is preferably at least 100 Pa, more preferably at least 125 Pa. In an exemplary embodiment, the peak pressure can be about 150 Pa. This direct pressure against the lumen wall is sufficient to completely remove all fluid or moisture from the inner surface of the lumen.

[0042] The variable pressure region of the drying element is configured to generate an average or intermediate pressure of at least about 10 Pa, preferably about 20 Pa, more preferably about 30 Pa, over the distance between the proximal and distal end portions of the drying element. In an exemplary embodiment, the intermediate pressure is about 36 Pa.

[0043] The variable pressure region of the drying element is also configured to generate a peak shear stress of at least about 4 Pa, preferably at least about 5 Pa, more preferably at least about 8 Pa within at least one region between the distal end portion and the proximal end portion of the drying element. The average shear stress or intermediate shear stress across the distance between the proximal end portion and the distal end portion of the drying element is greater than at least about 1 Pa, preferably about 2 Pa, more preferably greater than 2.5 Pa. In an exemplary embodiment, the intermediate shear stress is about 2.8 Pa.

[0044] In certain embodiments, the drying device / element includes more than one drying member. For example, in one such embodiment, the drying device includes from 2 to 10 drying members, preferably from 2 to 5 drying members. To enhance the effectiveness of the device, the drying members can be coupled to each other to provide a continuous or variously spaced such drying member along the navigation element. In these embodiments, for example, the proximal end portion of one drying member can be coupled to or integrated with the distal end portion of the next drying member along this continuous piece. Each of the drying members 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 central portion between the distal end portion and the proximal end portion. The central portion of each drying member is shaped to generate a pressure gradient along the central portion from the distal end portion to the proximal end portion. These variable pressure elements within each drying member can be the same or different to generate an alternating pressure profile. The plurality of cylindrical elements sandwiching the variable pressure elements can be a set of more or less than 5, appropriate for a given application.

[0045] In one embodiment, the drying element is removably coupled to an elongate navigation element such that it can be advanced through the lumen from the proximal end of an endoscopic lumen, such as a biopsy channel, to its distal end. In this case, the navigation element can be attached to the drying element such that the entire system can be withdrawn through the lumen from the distal end of the endoscope to its proximal end. This drying technique can be used to dry other lumens within the endoscope, including the suction channel and / or the air / water channel, when applicable. In other situations, this device can be used to dry channels or other endoscopic instruments from their proximal end to their distal end.

[0046] In embodiments, the drying member or the elongate navigation member can include elements that center the navigation element and the drying device when the device is pulled or pushed around a twist through the lumen and through other complex regions, including corners and junctions of multiple lumens and internal channels to be cleaned within the endoscope or other instrument. In embodiments, this centering element is smaller than the diameter of the lumen through which the device is advanced, but is sized significantly large enough to prevent misalignment and deflection of the navigation element to one side or the other of the lumen when the cleaning device is pulled or pushed around the curves, corners, and junctions (including Y-junctions) of the various lumens as the navigation element passes through.

[0047] In some embodiments, the centering element can include a series of shaped elements that project from the elongate member or the navigation member. This series of shaped elements can include, for example, struts, spikes, or other protrusions that extend radially outward from the elongate member and are sized to substantially center the elongate member and / or the drying / cleaning element within the internal channel of the endoscopic device.

[0048] The centering element can be of any shape that keeps the device approximately centered within the lumen and prevents the aforementioned flexure. A preferred embodiment is a cylindrical shape with a reduced-diameter distal end. When the device is drawn around the bends, corners, and junctions of the lumen, this type of mismatch, which is a problem with existing brushes and pull-through devices, occurs. The brush and other elements are drawn to one side of the lumen, resulting in minimal contact between the lumen wall and the drying element (whether it is a brush, pull-through device, or other device), and being detrimentally modified or lost, which has an adverse effect on the effectiveness of the drying method. By placing the centering element in front of, behind, or both in front of and behind the device, this problem is corrected, and in particular, more consistent and effective drying is provided around the bends, corners, channel junctions, and other complex areas inside an endoscope, other endoscope instruments, or endoscope devices.

[0049] In a preferred embodiment, the centering element has a diameter or height between 50 percent and 90 percent of the diameter of the lumen being cleaned, and in a more preferred embodiment, between 70 percent and 85 percent of the diameter of the lumen being cleaned. The centering element can be of any shape that maintains the centered state of the drying element when the drying element is navigated through the channel. In embodiments, this shape includes cylindrical, conical, spherical, and the centering element can be placed at the distal region, distal and proximal ends, between the drying members, or at the proximal end of the device, which is suitable to help center the drying element when the drying element navigates around the bend of the lumen, crosses a Y-junction, and navigates other scenarios.

[0050] In certain embodiments, the drying device includes a programmable motor configured to be coupled to the elongate member and translate the device through the lumen of the endoscope instrument. Preferably, the programmable motor is configured to draw the elongate member through the lumen a specified distance over a specified duration. For example, the motor can be programmed to draw the elongate member at a particular speed that optimizes the high speed at which the variable pressure region is generated within the drying member, thereby ensuring that the internal lumen is sufficiently dried without damaging the surface.

[0051] In another aspect, a kit for cleaning and drying an endoscope instrument includes a drying device having an advancement element configured to advance through the lumen within the endoscope instrument and at least one drying member coupled to a portion of the advancement element. At least a portion of the drying member is shaped and configured to substantially maintain contact with the wall of the lumen when advancing the advancement element through the lumen. The kit further includes a cleaning device having an elongate member configured to advance through the lumen within the endoscope instrument and at least one cleaning member coupled to a portion of the second elongate member. The cleaning member includes a distal end portion, a proximal end portion, and a central portion between the distal end portion and the proximal end portion, the central portion being shaped to generate a pressure gradient as it descends from the distal end portion to the proximal end portion.

[0052] In one embodiment, the drying device is one of the above-described embodiments and includes a distal end portion, a proximal end portion, and a central portion between the distal end portion and the proximal end portion, the central portion being shaped to generate a pressure gradient as it descends from the distal end portion to the proximal end portion.

[0053] The cleaning device can include any of the combinations of elements described above with respect to the drying device. The variable pressure central portion of the cleaning device is designed to generate a variable pressure between two circumferential elements and the wall of the channel being cleaned. Thus, when the cleaning member is advanced inside the channel, i.e., the cleaning element is moved through the lumen and the sight glass and the channel of the sight glass are submerged in the cleaning fluid (as required by the sight glass manufacturer), the variable pressure design between the two circumferential elements generates either a vortex, a Venturi effect, an inverse Venturi effect or a counter Venturi effect, or some other variable pressure between the cleaning element and the wall of the endoscope channel. As a result, when the cleaning fluid flows across the variable pressure zone, this zone affects the fluid flow such that the fluid crosses from the high pressure zone to the low pressure zone and then moves to another high pressure zone between the two cylindrical elements and returns pressure-wise. This induces the cleaning fluid located at the location of the channel wall at a high speed and force, thereby removing more biological material and other debris than conventional devices. In embodiments using a drying device, this same approach is applied, in which case, when moving the device through the channel to remove fluid and moisture and dry the channel, air is induced by the generation of either a vortex, a Venturi effect, an inverse Venturi effect or a counter Venturi effect, or some other variable pressure between the drying element and the wall of the channel.

[0054] In certain embodiments, the drying device of the kit can include an advancing element that can be a filament, wire, tube, or other element having the function of advancing into internal channels including long, curved, or other channels that are difficult to access by being recessed or internal. In embodiments, this element is gripped at the end after being pulled through the internal channel and can then be pulled through the channel as part of the drying process. Similarly, the advancing element can be advanced by pushing the element from the other end. This element can include versions that can advance air through the device into the channel including locations within the channel that are removed from the typical effects of forced air drying deep within the channel.

[0055] The drying member can include one or more substantially cylindrical members spaced apart from each other along the advancing member. The cylindrical members are configured to maintain contact with the channel wall to allow any moisture to move and be removed as the advancing element travels through the channel. The advancing element can be advanced by being pushed in and pulled out, or by other means including back-and-forth rocking, pattern-based advancement and withdrawal. The advancing element can proceed through the scope by connection to any other means of moving, absorbing, and / or removing water through the channel by automated or mechanized means or by direct contact with the surface area to be at least partially dried.

[0056] The drying member can be a disk, fin, squeegee, or other protrusion extending outwardly from the elongate member. In embodiments, the drying member is shaped to create a consistent circumferential contact with the inner walls of these channels when the elongate member is advanced through an endoscopic channel such as a biopsy channel or a suction channel.

[0057] In certain embodiments, the drying member preferably has a substantially annular, circumferential, cylindrical, or conical shape where at least one portion of this element has a diameter approximately equal to or slightly larger than the diameter of the inner lumen. In an exemplary embodiment, the diameters of the proximal end portion and the distal end portion are from about 1 times to about 1.5 times the diameter of the inner lumen, preferably about 1.25 times this diameter. This avoids deflection of the proximal end portion and the distal end portion and thereby reduces buckling and the creation of a gap between the drying element and the inner wall of the lumen.

[0058] In certain embodiments, the elongate member of the drying device includes a filament, wire, tube, shaft, or other element having the function of advancing into internal channels that are long, curved, or include other channels that are difficult to access by being recessed or internal. In an embodiment, this element is gripped at an end after being pulled through the internal channel and can then be pulled through the channel as part of the drying process. Similarly, this advancing element can be advanced by pushing the element from the other end. This element can include versions that can advance air through the device into channels that include locations within the channel that are removed from the typical effects of forced air drying deep within the channel.

[0059] The drying member can include one or more substantially annular or cylindrical members spaced apart from each other down the elongate member. The cylindrical members are configured to maintain contact with the channel walls to move and remove any moisture as the elongate element progresses through the channel. The elongate element can be advanced by being pushed and pulled, or by other means including back-and-forth rocking, pattern-based advancement and withdrawal. The elongate element can proceed through the sight glass by connection to any other means of moving, absorbing, and / or removing water through the channel to move a channel drying element through the channel either by automated or mechanized means or by direct contact with the surface area to be at least partially dried.

[0060] In an embodiment, the drying element of the present invention can be any shape or form including squeegees, disks, fins, cylinders, a series of absorbent strips, venturi or reverse venturi shapes, oblong and round shapes, ball or spherical drying elements that can move water and moisture by their forward movement or extraction. The fins, disks, squeegees, or other annular members, or other drying members can be at any angle that is vertical or inclined backward at an angle between 1 degree and 89 degrees or inclined forward at an angle between 1 degree and 89 degrees to promote and assist drying, or at any other angle that facilitates drying. In an embodiment, these angles should not be limited to this description and should vary based on which is most effective for drying for a given channel drying application.

[0061] In an embodiment, the drying member can include a series of one or more cylindrical squeegees designed to make wall contact with the inner wall of the channel to remove fluid and moisture from the channel. These cylindrical squeegees can be arranged in any manner effective for removing fluid and moisture from the channel. This arrangement can include an arrangement of two squeegee groups followed by three groups or vice versa, or other squeegee configurations, such as one squeegee group followed by two groups, two groups followed by four groups, three groups and four groups, four in a row, five in a row, or any other number and configuration of squeegees effective for removing water and moisture and depending on the diameter, length, curvature of the channel, junction with other channels, and other factors.

[0062] In an embodiment, some of these squeegees can be of different heights to enable the device to be widely adaptable for use in channels of different sizes by using channels of different sizes. For example, the device can have a squeegee with a diameter ranging from 5 mm to 5.2 mm, followed by a smaller squeegee with a diameter between 2 mm and 2.2 mm, and then another squeegee with a diameter ranging from 3.8 mm to 4 mm to generate variable wall contact across different channel sizes. In an embodiment, the height and arrangement of the squeegees are not limited to this description, and these diameters, arrangements, squeegee thicknesses, and others can vary based on what is most effective for drying for a given channel drying application.

[0063] The spacing between the squeegee and any other elements including the drying elements can be any spacing that promotes rapid and predictable channel drying, including spacings of 1 mm, 1.25 mm, 1.5 mm, a spacing of 2 mm, a narrow spacing of 1.25 mm, followed by a gap of 4 mm, and then a spacing between 1.25 mm and 1.5 mm, or other spacings that are narrowed, widened, or more varied to optimize and promote rapid and predictable channel drying. The spacing, diameter, alignment, and grouping of the drying elements can, in an embodiment, vary based on the channel size, channel material, number of bends when navigating in each direction, number of junctions with other channels, material of the channel dryer if any exists, and other factors unique to a given channel drying application.

[0064] The thickness of the squeegee and fins can be any thickness that aids in channel drying, further dries, and in an embodiment, aids in the positioning of the fins and squeegee that are to be cleaned. In an embodiment, this thickness includes squeegee and fin thicknesses between 0.2 mm and 0.5 mm, other variations with a thickness from 0.5 mm to 1.0 mm, and other different values including a tapered thickness that is thicker at the base of the squeegee or fin and tapers as it approaches the channel wall to improve the deflection and conformity of the element to the channel wall while simultaneously providing support around the advancing element and providing a predetermined rigidity and flexibility.

[0065] The annular members descend along the elongated member and are spaced apart from each other. In some embodiments, the distance between each of the annular members is substantially equal. In other embodiments, this distance can vary between some or all of the annular members. For example, the device can include first, second, and third annular members where the first annular member and the second annular member are spaced apart by a greater distance than the distance by which the second annular member and the third annular member are spaced apart from each other.

[0066] In one embodiment, it includes at least first and second groups of annular members, each having a plurality of annular members. The annular members within each group can be spaced apart from each other substantially equally or can have different spacings. The first group is spaced apart from the second group by a greater distance than the spacing within each of the first and second groups.

[0067] In another embodiment, the elongated member includes a rod member having a first end and a second end, and a loop coupled to the first end. The device can further include a swap member having a first end attached to the loop and a second end including a tail. The swap member can have first and second ends where the first end is attached to the loop and the second end includes a tail like that of a kite tail, and the tail can be of any length. The swap member can include one or more materials that can be braided or twisted, and the tail end of the swap member includes an unbraided or untwisted end composed of one or more of the materials that make up the swap member. Further, the swap member can include a foam material and / or a microfiber material.

[0068] Further, the rod member can include a single continuous polymer rod where its looped end includes one thickness or diameter and its linear end includes two thicknesses or diameters of the looped end of the rod. The two thicknesses or diameters of the polymer rod forming the linear end of the rod member can be melted or joined to each other, adhered to each other, or co-extruded.

[0069] In an embodiment, the drying device includes a centering element that keeps the drying element centered as it advances through the channel to be dried. This centering element prevents the drying element from losing contact with the wall of the channel being dried and enhances the drying effect. The centering element can be of any shape that keeps the device substantially centered within the lumen and prevents the above-described flexure. A preferred embodiment is a cylindrical shape with a reduced-diameter distal end. When the device is pulled around the bends, corners, and junctions of the lumen, this type of mismatch, which is a problem with existing brushes and pull-through devices, is generated. As a result, the brush and other elements are pulled to one side of the lumen, minimizing, detrimentally modifying, or losing contact between the lumen wall and the drying element (whether it is a brush, a pull-through device, or any other device), and causing an adverse effect on the effectiveness of the drying method. By placing the centering element in front of, behind, or both in front of and behind the device, this problem is corrected, and in particular, a more consistent and effective drying is provided around the bends, corners, channel junctions, and other complex areas inside an endoscope, other endoscope instruments, or an endoscope device.

[0070] In a preferred embodiment, the centering element is between 50 percent and 90 percent of the diameter of the lumen to be cleaned, and a more preferred embodiment has a diameter or height between 70 percent and 85 percent of the diameter of the lumen to be cleaned.

[0071] In some embodiments, the centering element can include a series of shaped elements protruding from an elongate member or a navigation member. This series of shaped elements can include, for example, struts, spikes, or other protrusions that extend radially outward from the elongate member and are sized to substantially center the elongate member and / or the drying / cleaning element within the internal channel of the endoscope device.

[0072] In another aspect, a kit for cleaning and drying an endoscopic instrument includes a drying / cleaning device having an elongate member configured to advance through a lumen within the endoscopic instrument and at least one cleaning / drying member coupled to a portion of the second elongate member. The cleaning / drying member includes a distal end portion, a proximal end portion, and a central portion between the distal end portion and the proximal end portion, the central portion being shaped to create a pressure gradient as it descends from the distal end portion to the proximal end portion.

[0073] In this aspect, the drying / cleaning device is configured to be passed through and cleaned within the internal lumen while being dried therewith. In an embodiment, this version can be particularly advantageous for cleaning and drying after using liquid chemical sterilants and chemical disinfectants.

[0074] In a preferred embodiment, the present invention is configured for use with an endoscope. The advancing element is a polymer filament, wire, or tube. The material for the advancing element can be any one suitable for the contemplated use, which in an embodiment can be polypropylene, PET, nylon, PEEK, PTFE, ETFE, polyurethane, high or low density polyethylene, or other suitable polymeric materials. The advancing element can be a combination of materials including a metal wire (including stainless steel, nitinol, or other materials), or a polymer reinforced by a wire, a wire covered by a polymer, or a combination thereof.

[0075] In one embodiment, the drying element is formed by injection molding, 3D printing, or otherwise, or is otherwise formed or attached by covering, connecting, or gluing to the advancing element. The drying element is of any durometer hardness that aids in drying the channel, but in a preferred embodiment, the durometer hardness of the material is between 35 Shore A and 70 Shore A. In an embodiment, the drying element can be manufactured from any elastomeric material or any elastic material including Pebax, polyurethane, Santoprene, silicone, high or low density polyethylene, EVA, and other elastomeric materials. In an embodiment, it is contemplated that the drying element can be a combination of materials including combinations of hard and soft materials having various elasticities.

[0076] In an embodiment, the deformation of the drying portion of the present invention can include materials that can absorb water, such as sponges, absorbent fabric materials, or other materials that can absorb and retain moisture and water. These materials can be attached to the advancing element as single or various lengths of material strips, overlapping materials, round balls, or any other shape that aids in the removal of water and moisture from the channel when the advancing element passes through the channel. These absorbent materials can be placed at the end or beginning of the drying element or interspersed between other drying elements such as squeegees or fins.

[0077] In an embodiment, the drying element of the present invention can be of any shape or form including squeegees, cylinders, a series of absorbent strips, venturi or reverse venturi shapes, oblong and round shapes, ball or spherical drying elements that can move water and moisture by its advancement or withdrawal.

[0078] The present invention can include a coating that aids in hydrophilic or hydrophobic and aids in navigation by changing the friction level. The present invention can have a lumen that allows air to blow through the present invention to force air to be delivered close to the channel wall inside the channel or to a depth in its immediate vicinity.

[0079] In another aspect, a method of drying one or more lumens within an endoscopic instrument includes advancing an elongate member having at least one drying member through the lumen within the endoscopic instrument and creating a pressure gradient down the central portion of the drying member. This pressure gradient provides an increase in the relative velocity between the drying member and any air or fluid within the lumen as the drying member is advanced through the lumen. The high velocity of the fluid or air enhances the shear stress between the fluid or air and the lumen wall, thereby creating a stronger force for drying the wall.

[0080] In an embodiment, the central portion of the drying member includes a constriction section coupled to the proximal end portion, a diffuser section coupled to the distal end portion, and a throat section coupling the diffuser section and the constriction section, the throat section having a diameter smaller than the diameters of the proximal end portion and the distal end portion and larger than the diameters of the diffuser section and the constriction section.

[0081] In an embodiment, the method further includes centering the drying member within the lumen as the drying member is advanced through the lumen. Preferably, the centering element is smaller than the diameter of the lumen through which the device is advanced, but is of a size significantly sufficient to prevent misalignment and deflection of the navigation element to one side or the other of the lumen as the navigation element, including when the drying device is withdrawn or pushed through around the bends, corners, and junctions (including Y-junctions) of various lumens, passes through.

[0082] The method includes introducing a guide element through a first opening within the lumen of the instrument and advancing an elongate drying device through a second opening within the lumen such that at least a portion of the elongate drying device engages the guide element. The guide element engages and couples to the drying device such that the drying device can thereby be withdrawn relative to the first opening of the lumen.

[0083] In certain embodiments, the endoscopic lumen includes a first lumen and a second lumen that are coupled to each other at a junction, such as a Y-junction, between a biopsy channel and a suction channel within the endoscope. In these embodiments, the method further includes introducing a guide element through the first lumen, past the junction, and into the second lumen, and advancing an elongate drying device through the second lumen such that the elongate drying device engages the guide element. Thereafter, the guide element can be used to withdraw the drying device through the junction and through the first lumen. This ensures that the drying device dries the biopsy channel without flexing and passing proximally past the Y-junction and deeper into the suction channel.

[0084] In other embodiments, the endoscopic lumen includes a twist or bend having a relatively small radius of curvature that is considered difficult to advance a drying element therethrough. In these embodiments, the guide element is introduced and advanced through the lumen on one side of the twist. The drying device is advanced or retracted through the lumen on the other side of the twist until it engages the guide element. The guide element is then withdrawn to pull the drying device through the twist.

[0085] The guide element can include a tubular sheath or similar device having a distal end portion configured to engage the distal 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 can have an inner diameter larger than the outer diameter of the proximal end portion of the elongate drying element and can be further configured to distort or otherwise guide the drying element past a junction or other intricate area within the lumen.

[0086] In certain embodiments, the tip of the guide element is inclined to further conform to the shape of the multi-channel internal junction within the endoscope. In an embodiment, the proximal end of the guide element can have a flange larger than the inlet opening to the particular endoscope channel into which the navigation element is inserted so that the navigation element can be fully advanced into the channel without resulting in difficulty in withdrawal. In an alternative embodiment, the navigation element may not have a flange, but can have a marker including, for example, a pad print line or other line that defines the boundary of the maximum recommended point of advancement of the navigation element into the endoscope channel or other channel.

[0087] In other embodiments, the cleaning / drying device can have one or more absorbent sponges disposed in front of or at the end of the cleaning / drying device or between one or more of the cylindrical elements to absorb biological material and debris. The absorbent sponge can be of a single cell configuration or have multiple sponges with different cell configurations in providing wiping, absorption, flaking, diffusion, or a combination of these attributes of the cleaning fluid. The absorbent sponge can include any material that absorbs biological material, fluid, or other debris, such as polymers, foams, sponges, bamboo, hemp fibers, microfibers, polyurethane, or polyvinyl alcohol. In one embodiment, the cleaning member includes a spongy 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 that allows the sponge to expand when hydrated. Preferably, the material is selected such that in a preferred embodiment, the sponge has the function of expanding at least to the inner surface of the lumen while maintaining sufficient absorbency to absorb a volume of material or fluid at least equal to the volume of the segment of the lumen occupied by the sponge.

[0088] In an embodiment, the sponge is soft and non-traumatic when submerged in a fluid and expands to a size sufficient to remove debris from (and / or remove moisture and fluid from) at least the channels to be cleaned, and in a preferred embodiment is larger than the channels to be cleaned. The sponge can be of any shape and size that fits and aids in cleaning the channels of the sight glass, such as, but not limited to, cylindrical, helical, conical, triangular, square, or any combination thereof.

[0089] For example, the cleaning or drying member can have more than one cylindrical element, such as a cylindrical or other shaped element, disposed in close proximity to another element at intervals that do not generate a variable pressure on average between the elements, and then or instead thereof have a cylindrical element having an interval that generates a variable pressure between the cleaning / drying member and the wall of the channel to be cleaned between the next cylindrical element. In an embodiment, a series of cylindrical elements can be arranged with various intervals that generate a variable pressure between the cylindrical elements and a predetermined interval that generates a constant pressure between the cylindrical elements.

[0090] In other embodiments, the devices disclosed herein can be used to dry and / or clean indwelling devices. In these embodiments, the device can further include a sheath or similar structure that covers the cleaning element and / or drying element, and / or navigation element to avoid disturbing any biofilm accumulated therein and any biological material while translating through the lumen of the instrument. The system can include a measurement device, such as a marker, on the navigation element or a separate elongate element to confirm positioning of the device into the lumen of the catheter. The polymer forming the cleaning element and / or drying element can expand when the sheath is withdrawn. Alternatively, electro-responsive polymers can be used to change and expand the shape by applying energy to expand these polymers to contact or at least partially contact the wall of the catheter.

[0091] The device can include a coating that is hydrophobic. In yet another embodiment, the device has superhydrophobic and / or oleophobic properties. In yet another embodiment, the device has anti-infective and hydrophobic properties. In yet another embodiment, the device has anti-infective and superhydrophobic properties. In yet another exemplary embodiment, an anti-inflammatory coating is incorporated within the device. In other embodiments, the anti-inflammatory coating can include a hydrophilic material or the coating is hydrophilic.

[0092] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the description. Additional features of this description are partly listed in the following description or can be acquired by the implementation of this description.

[0093] The accompanying drawings, which are incorporated herein and constitute a part of this specification, illustrate some embodiments of this description and are helpful in explaining the principles of this description together with this description.

Brief Description of the Drawings

[0094]

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DETAILED DESCRIPTION OF THE INVENTION

[0095] This description and the accompanying drawings illustrate a plurality of exemplary embodiments and should not be construed as limiting. The claims define the scope of this description, including equivalents. Various mechanical, compositional, structural, and operational changes can be made without departing from the scope of this description and the claims including equivalents. In some instances, well-known structures and techniques are not shown or described in detail so as not to obscure the description. Similar numbers in two or more figures represent the same or similar elements. Further, elements and related aspects described in detail with reference to one embodiment can be included in other embodiments as long as they can be implemented in those other embodiments without specifically showing or describing them. For example, even if an element is described in detail with respect to one embodiment and not described with respect to a second embodiment, that element can be claimed as being included in the second embodiment. Additionally, the depictions herein are for illustrative purposes only and do not necessarily reflect the actual shape, size, or dimensions of the system or the exemplary components being illustrated.

[0096] Note that, as used in this specification and the appended claims, the singular forms "a," "an," and "the," and any singular use of any word, include plural referents unless expressly and unambiguously limited to one referent. The term "comprising," as used herein and in its grammatical variations, is intended to be non-limiting such that the recitation of items does not exclude other similar items that can be substituted for or added to those recited items.

[0097] The following description is primarily directed to an endoscope and a device for cleaning and / or drying the same, but it should be understood that the features of the disinfection system of this description can be readily adapted for use with various reusable or disposable endoscopic instruments and endoscopic devices, including internal lumens and other internal spaces such as trocars, cannulas, dilation devices, Foley catheters, guidewires, central venous catheters, bipolar or monopolar electrosurgical devices or ultrasonic devices, lung ventilation devices, ventilators, CPAP and other positive pressure airway devices, robotic surgical instruments and remote surgical instruments, arterial lines, drainage catheters, peripherally inserted central catheters, endotracheal tubes, feeding tubes, and other devices deployed, inserted, and / or navigated within the body, such as endoscopes, laparoscopes, arthroscopes, colonoscopes, gastroscopes, duodenoscopes, endoscopic ultrasound devices, bronchoscopes, enteroscopes, cystoscopes, laparoscopes, laryngoscopes, sigmoidoscopes, thoracoscopes, heart scopes, and vein collectors using a scope, whether for medical use (human or otherwise) or for any other use, robotic, non-robotic, or non-medical.

[0098] As used herein, the term "endoscope" refers to any scope used in or for medical applications, including the body (human or otherwise), and includes, for example, laparoscopes, arthroscopes, colonoscopes, gastroscopes, duodenoscopes, endoscopic ultrasound devices, bronchoscopes, enteroscopes, cystoscopes, laparoscopes, laryngoscopes, sigmoidoscopes, thoracoscopes, heart scopes, and vein collectors using a scope, whether for robotic, non-robotic, or non-medical use, regardless of the type of application.

[0099] When performing remote visualization within a patient's body, various endoscopes are used. The endoscope used depends on the degree of need for the physician to navigate within the body, the type of surgical instrument used in the procedure, and the appropriate level of invasiveness for the type of procedure. For example, visualization of the inside of the gastrointestinal tract may involve the use of flexible gastroscopes and colonoscopes, as well as endoscopes in the form of special duodenoscopes having lengths that can span several feet and diameters that may be greater than one centimeter. These endoscopes can be rotated and articulated or steered by the physician when the endoscope is navigated through the patient. Many of these endoscopes include one or more working channels for passing and supporting instruments, fluid channels and irrigation channels for perfusing tissue to clean the endoscope, gas injection channels for injecting gas to improve navigation and visualization, and one or more light guides for illuminating the field of view of the endoscope.

[0100] In medical applications, smaller, less flexible or rigid endoscopes or endoscopes having a combination of flexibility and rigidity are also used. For example, smaller, thinner, and considerably shorter endoscopes are used when examining joints and performing arthroscopic surgery, such as surgery on the shoulder or knee. When a surgeon uses arthroscopic surgery to repair a torn meniscus within the knee, generally a shorter, more rigid endoscope is inserted through a small incision on one side of the knee to visualize the damage, while at the same time instruments are passed through an incision on the opposite side of the knee. These instruments can perfuse the endoscope inside the knee to maintain visualization and manipulate tissue to complete the repair.

[0101] In diagnostic and procedural uses of minimally invasive endoscopic procedures, other endoscopes may be used, including, by way of example, endoscopes for examining and treating conditions in the lungs (bronchoscopes), in the mouth (enteroscopes), in the urethra (cystoscopes), in the abdomen and peritoneal cavity (laparoscopes), in the nose and paranasal sinuses (laryngoscopes), in the anus (sigmoidoscopes), and in other aspects of the gastrointestinal tract (gastroscopes, duodenoscopes, colonoscopes), in the chest and thoracic cavity (thoracoscopes), but not limited thereto. Further, robotic medical devices also rely on endoscopes for remote visualization of the site at which they are performing evaluations and procedures.

[0102] These and other endoscopes can be inserted through natural orifices (such as the mouth, paranasal sinuses, ear, urethra, anus, and vagina), and further through incisions and port-based openings at the patient's skin, cavity, skull, joint, or other medically designated entry point. Diagnostic uses of endoscopic examination by visualization using these medical endoscopes can include examining symptoms of diseases such as those of the digestive system (e.g., nausea, vomiting, abdominal pain, gastrointestinal bleeding), can confirm a diagnosis (e.g., by performing biopsies regarding anemia, bleeding, inflammation, and cancer), or can include surgical procedures for diseases (removal of a ruptured appendix or cauterization of a gastric bleed).

[0103] Referring now to FIG. 1, a representative endoscope 10 includes a proximal handle 12 adapted for manipulation by a surgeon or clinician and coupled to an elongate shaft 14 adapted for insertion into a patient's body cavity by endoscopic or percutaneous penetration. The endoscope 10 further includes a fluid delivery system 16 coupled to the handle 12 through a universal cord 15. The fluid delivery system 16 includes several different tubes coupled to an internal lumen within the shaft 14 for delivery and aspiration of fluids such as water and air, and other features that a clinician may desire to move fluids, blood, debris, and particulate matter from the field of view. This exclusion provides a clearer view of deeper tissues or substances for evaluation and treatment. In this representative embodiment, the fluid delivery system 16 includes a water injection connector 18, a water cylinder connector 20, a suction connector 22, and an air pipe 24. The water injection connector 18 is coupled to an internal water injection lumen 28 that extends through the handle 12 and the elongate shaft 14 to the distal end of the endoscope 10. Similarly, each of the water cylinder connector 20, the suction connector 22, and the air pipe 24 is connected to internal lumens 30, 32, 34 that pass through the shaft 14 to the distal end of the endoscope 10, respectively.

[0104] The proximal handle 12 can include various controllers for a surgeon or clinician to operate the fluid delivery system 16. In this representative embodiment, the handle 12 includes a suction valve 34, an air / water valve 36, and a biopsy valve 38 for removing a tissue sample from a patient. The suction channel 34 originates from the suction connector 22, forms a relatively sharp twist or bend 22A, and extends into the handle 12 through the universal cord 15. Next, the suction channel 34 extends through the shaft 14 to the distal end of the endoscope 10. The suction channel 34 forms an internal Y-junction 38B with a channel 38C that extends into the biopsy valve 38 at the location where it passes through the biopsy valve 38. This Y-junction 38b presents challenges when cleaning and / or drying the suction channel 34 using conventional devices, as will be discussed in more detail below.

[0105] In certain embodiments, the handle 12 further includes an eyepiece (not shown) coupled to an image capture device (not shown) such as a lens and a light transmission system. Similarly, as used herein, the term "image capture device" does not necessarily refer only to a device having only a lens or other light guiding structure. In contrast to such a device, for example, an image capture device can be any device capable of capturing and transmitting an image and including (i) a relay lens between the objective lens and the eyepiece at the distal end of the endoscope, (ii) an optical fiber, (iii) a charge coupled device (CCD), or (iv) a complementary metal oxide semiconductor (CMOS) sensor. The image capture device can be merely a chip for sensing light and generating a communication electrical signal corresponding to the sensed light or other techniques for transmitting an image. The image capture device can have an observation end where light is captured. Generally, the image capture device can be any device capable of observing an object, capturing an image, and / or capturing an image.

[0106] In some embodiments, the endoscope 10 includes some form of positioning assembly (e.g., a hand controller) attached to the proximal end of the shaft to enable an operator to manipulate the viewing lens. In other embodiments, the viewing lens is part of a robotic element that provides steerability of the viewing lens to a desired point for examining and focusing the viewing lens and enables positioning of the viewing lens.

[0107] As shown in FIG. 2, the endoscope 10 can further include a camera lens 62 for providing a view of the surgical site within the patient's body, an endoscope washer 32, and a light source 60, and a biopsy channel 50 for passing instruments therethrough. The biopsy channel 50 enables the passage of instruments along the shaft 14 of the endoscope 10 for removing tissue. The biopsy channel 50 can act as an operating channel for other instruments to pass through the endoscope 10 for the evaluation and procedure of tissue and other substances. Such instruments can include cannulas, catheters, stents and stent delivery systems, papillotomes, wires, other imaging devices including mini endoscopes, baskets, snares, and other devices for use in combination with the endoscope within the lumen. Alternatively, the endoscope 10 can include separate operating channels for these instruments.

[0108] FIG. 3 shows the internal lumen 70 of a representative endoscope, such as a biopsy channel, an operating instrument channel, or a water / air channel. As shown, the inner surface of the lumen 70 has been subject to either damage during past procedures or damage by conventional cleaning devices. Thus, the lumen 70 includes many defects 72 that provide small areas for hiding pathogens, biological substances, tissue, or other debris therein. These defects 72 are very difficult to clean and dry using conventional devices. Further, since these defects hide biological substances, the biological substances protect the pathogens within them from conventional sterilization and disinfection techniques.

[0109] Next, an exemplary cleaning and / or drying device will be described below. The cleaning and / or drying device includes an elongated shaft and a cleaning and / or drying member disposed on a portion thereof. The cleaning and / or drying member can be removably attached or permanently fixed to the shaft. The shaft can include any suitable material that provides sufficient rigidity to advance it through the lumen of the endoscope. The elongated shaft has an outer diameter sized to fit within and translate through the internal lumen of the endoscope 10. In this exemplary embodiment, the shaft will have an outer diameter in the range of from about 0.5 mm to about 5 mm, preferably from about 1 mm to 4 mm.

[0110] In certain embodiments, the device includes a withdrawal cable configured to withdraw or advance the elongated shaft within the internal lumen of the endoscope 10. Further, the device can include an energy source and a motor for advancing and / or withdrawing the elongated shaft. Of course, it will be recognized that the elongated shaft can be manually translated through the internal lumen by a proximal handle or a suitable actuator (i.e., not a motor).

[0111] Next, with reference to FIG. 4, a portion of a cleaning and / or drying device 200 according to a certain embodiment will be described below. The cleaning and / or drying device 200 includes one or more cleaning and / or drying elements 300 attached to a pushing and pulling element such as a navigation element 301 (only a portion of which is shown in FIG. 4). The navigation element 301 can be advanced from the proximal end to the distal end of any internal lumen associated with the endoscope (or vice versa). For example, in one embodiment, the navigation element 301 is advanced to the distal end of the biopsy channel so as to exit the biopsy channel of the endoscope and connect to the cleaning and / or drying element. The navigation element 301 can be advanced to the distal end of the biopsy channel (or aspiration channel when applicable) so as to exit the biopsy channel from the proximal end of the biopsy channel of the endoscope and connect to the cleaning and / or drying element, or alternatively, can be advanced through the channel from the proximal end to the distal end of the biopsy channel (or aspiration channel) and withdrawn. This pushing and / or pulling navigation element can be attached to the cleaning and / or drying element 300 and is separable in some embodiments and can be permanently attached in other embodiments.

[0112] As shown in FIG. 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 be passed through the internal lumen of the endoscope device. For example, the navigation element 301 can be advanced down the biopsy channel 38C from the proximal inlet to the biopsy channel 38C, exit from the distal end of the biopsy channel, and connect to the cleaning and / or drying element 300, and then the entire system can be withdrawn so as to exit from the distal end of the endoscope to the biopsy channel and then from the proximal end of the biopsy channel. This technique enables successful cleaning of the biopsy channel without having the problems of the current technique that accumulate debris and biological substances, extrude them from the distal end of the biopsy channel, and cause excessive contamination in the most difficult part of the endoscope to clean. Further, this technique also enables successful drying of the biopsy channel.

[0113] The unique function of advancing the navigation element, then connecting to the cleaning and / or drying element at the distal end of the endoscope, and further pulling it from the distal end to the proximal end of the endoscope successfully cleans and / or dries without increasing the contamination level at the distal end of the endoscope, which is the most difficult to clean, or alternatively enters the deflection tube through the Y-junction in the endoscope and cleans and / or dries from the distal to the proximal by passing through the preferred side of the Y-junction. This technique for cleaning and / or drying can be used to clean or dry other lumens within the endoscope that include a suction channel and / or an air / water channel when applicable.

[0114] In other embodiments, the navigation element 301 and the cleaning and / or drying element 300 are adhered to each other and 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 separately manufactured and attached to each other prior to use.

[0115] The channel element 300 preferably includes a proximal end portion and a distal end portion that are at least two channel wall contact elements 302, 304 that are generally cylindrical in shape to conform to the shape of the endoscope channel. The wall contact elements 302, 304 create a consistent circumferential contact point with the inner wall of the endoscope channel, such as a biopsy channel or a suction channel. In certain embodiments, the channel element can include secondary wall contact elements 303, 305 (or further additional similar elements if desired) to improve the engagement between the wall contact element and the inner lumen wall to ensure that the variable pressure region (discussed below) is effective.

[0116] The channel contact elements 302, 304 can include any suitable shape that substantially conforms to the wall of the internal lumen. In certain embodiments, the channel contact elements 302, 304 preferably have a substantially circumferential, cylindrical, or conical shape with at least one portion thereof having a diameter that is approximately equal to or slightly larger than the diameter of the internal lumen. In an exemplary embodiment, the maximum diameter of the channel contact elements 302, 204 is from about 1 to about 1.5 times the diameter of the internal lumen, preferably about 1.23 times this diameter. For example, when the diameter of the internal lumen is about 5 mm, the maximum diameter portion of the elements 302, 304 can be from about 4.2 mm to 5.5 mm, preferably about 5 mm. This additional size allows the elements 302, 304 to deform slightly as they pass through the lumen, ensuring that these elements remain in contact with the lumen.

[0117] In certain embodiments, the contact elements are substantially conical such that they slope downward in the proximal direction (or the direction of advancement of the cleaning and / or drying device through the lumen of the endoscope). This configuration allows the contact elements 302, 304 to generate a contact frictional force along the inner wall of the lumen such that at least a portion of the contact elements 302, 304 remains in contact with the lumen while sliding along the wall of the internal lumen of the endoscope without getting caught or otherwise immobilized within the lumen. In an exemplary embodiment, the contact elements 302, 304 are about 0.75 mm and taper to about 0.5 mm at the tip (or the point of contact with the inner wall of the lumen).

[0118] The cleaning and / or drying element 300 further includes a variable pressure region 306 between wall contact elements 302 and 304. The variable pressure region 306 is designed to create a variable pressure between the two circumferential contact elements 302 and 304 and the wall of the channel to be cleaned. Thus, when the cleaning and / or drying member is advanced inside the channel, i.e., the cleaning and / or drying element is moved through the lumen, and the scope and its channel are submerged in a cleaning fluid (which can be saline or any other biocompatible material safe to use in combination with an indwelling catheter as required by the scope manufacturer), the variable pressure design between the two circumferential elements creates a vortex, a Venturi effect, an inverse Venturi effect, or a counter-Venturi effect, or any other variable pressure between the cleaning and / or drying element and the wall of the endoscope channel. As a result, when the cleaning fluid flows across the variable pressure region, this region affects the fluid flow such that the fluid flows from a high-pressure region across a low-pressure region and then to another high-pressure region between the two cylindrical elements and returns pressure-wise. This is similar to the Venturi effect created when a thumb is placed over the end of a hose to increase the force of the water discharged from the hose, and it induces the cleaning fluid at the location of the channel wall at a high speed and force.

[0119] When used to dry the lumen, the forces generated by the variable pressure region 306 enhance the drying performance of the element 300. These forces enable the cleaning and / or drying element to substantially remove all fluid and moisture from the lumen.

[0120] Alternatively, the variable pressure region 306 can be designed to create low-pressure regions at both of its ends and a high-pressure region between these regions. In this embodiment, when the cleaning fluid or air flows across the variable pressure region, this region affects the fluid flow or air flow such that the fluid or air flows from a low-pressure region across a high-pressure region and then to another low-pressure region between the two cylindrical elements and returns pressure-wise.

[0121] As shown in FIG. 4, the variable pressure region 306 includes a constriction section 308 coupled to the proximal contact element 302, a diffuser section 312 coupled to the distal contact element 304, and a throat section 310 that couples the diffuser section 310 and the constriction section 308. The throat section 320 has a diameter smaller than the diameters of the contact elements 302, 204 and larger than the diameters of the diffuser and constriction sections 308, 310. This design redirects the fluid (or air when applicable) from the static interaction points with the walls of the sight glass channel to dynamic interaction points where the cleaning and / or drying member enhances the stripping action of the chemical agents of the cleaning fluid (or air in the case of drying) by inducing the fluid or air against the walls of the sight glass channel by pressure, thereby enhancing the performance of the cleaning fluid (or air).

[0122] The variable pressure region 306 can include a reverse partial venturi shape, a parabolic shape, a variable slope shape, or other shapes that generate a variable pressure between two cylindrical bodies and the channel wall to be cleaned, thereby increasing the force that projects the cleaning fluid or air against the channel wall when advancing the cleaning and / or drying member.

[0123] In an exemplary embodiment, the throat section 310 is substantially cylindrical. The constriction section 308 preferably expands in diameter from the contact section 302 to the throat section 310, and the diffuser section 312 preferably reduces in diameter from the throat section 310 to the contact section 304, thereby generating any one of a vortex, a venturi effect, a reverse venturi effect, or a counter-venturi effect, or other variable pressures between the distal end portion 304 and the proximal end portion 302 of the cleaning and / or drying element 310.

[0124] In a preferred embodiment, the variable pressure region 306 has an inverse partial venturi shape with three distinct regions having different distances from the wall of the viewing lens channel, which creates an accelerated hydrodynamic action that projects the cleaning fluid (or air) onto the channel wall for more substantial cleaning or a similar action in the case of air. These regions include the contraction section 308, which is the starting region where the cleaning fluid (or air) is present on the other side of the first cylindrical element. The contraction section 308 is the starting region where the available space for the fluid changes and decreases as the cleaning and / or drying element 300 advances, causing the fluid to accumulate and undergo a pressure change. The fluid (or air) is then induced into the throat section 310, which further changes the pressure between the cleaning and / or drying element and the channel wall. The throat section 310, where the available shape for the fluid becomes even smaller in a way that changes the pressure on the fluid compared to the pressure on the fluid (or air) within the contraction section, generates an acceleration of the fluid when advancing the cleaning element 300 and / or an acceleration of the air when advancing the drying element 300. Subsequently, the diffuser section 312 promotes the diffusion of the cleaning fluid (or air) at an accelerated velocity when the fluid (or air) exits the throat section. These sections between the cylindrical elements together generate sufficient hydrodynamic forces to remove bacteria, biological matter, and debris from the walls of the endoscope channel in the case of the cleaning fluid or similar forces to move water and moisture to dry the endoscope channel in the case of air. This hydrodynamic force applied to the air is also sufficient to remove substantially all moisture and fluid from the lumen during the drying process.

[0125] The inclination angle of the contraction section 308 (defined as the angle formed between the vertical section of the conical section 302 and the inclined portion of the contraction section 308) may vary depending on the diameter of the channel to be cleaned, the viscosity of the fluid (or the thickness of the air), and other factors, and must be sufficient to facilitate a variable pressure flow of the cleaning fluid or air between the cylindrical bodies when advancing the cleaning and / or drying element. In certain embodiments, the contraction section defines an angle between the proximal end portion (i.e., the contact section 302) of from about 4 degrees to about 85 degrees, preferably from about 15 degrees to about 30 degrees. Similarly, the diffuser section defines an angle between the distal end portion (i.e., the contact section 304) of from about 4 degrees to about 85 degrees, preferably from about 15 degrees to about 30 degrees. Of course, it will be recognized that the various pressure regions 306 can have more than one inclined shape, curved shape, variable shape, or other shape that aids in varying the pressure between the two cylindrical elements 302, 304.

[0126] Similarly, the angles between the contraction and diffuser sections 308, 312 and the throat section 310 may also vary depending on the diameter of the channel to be cleaned, the viscosity of the fluid or air, and other factors, and must be sufficient to facilitate a variable pressure flow of the cleaning fluid or air between the cylindrical bodies when advancing the cleaning and / or drying element. In certain embodiments, this angle is from about 10 degrees to about 50 degrees, preferably from about 15 degrees to about 30 degrees, more preferably from about 20 degrees to about 25 degrees.

[0127] The length and diameter of each section of the variable pressure region 306 are preferably selected to optimize any of a vortex, a Venturi effect, an inverse Venturi effect or a counter Venturi effect, or other variable pressures, 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 section 310 can be from about 2 mm to 10 mm, preferably from about 3 mm to 5 mm, more preferably about 4 mm. The outer diameter of the throat section 310 will also depend on the diameter of the internal lumen, as well as the diameters of the contraction section and the diffusion sections 308, 312. In certain embodiments, the throat section 310 is smaller in diameter than the internal lumen, but greater than 50% of the diameter of the lumen, preferably greater than about 60% of the diameter of the lumen, more preferably equal to or greater than about 70% of the diameter of the lumen (e.g., about 3 mm for a lumen having an inner diameter of about 4.2 mm).

[0128] The outer diameter of the navigation element 301 is preferably smaller than the diameter of the throat region 310. In an exemplary embodiment, this outer diameter is less than about 2.5 mm, preferably less than about 2.0 mm, more preferably about 1.75 mm.

[0129] The vortex, Venturi effect, inverse Venturi effect or anti-Venturi effect, or other variable pressure generated by the variable pressure region 306 affects the fluid flow (air flow when applicable) such that when the fluid flow crosses from a high-pressure region through the low-pressure region between two cylindrical elements and moves to another high-pressure region and returns pressure-wise, it is similar to the Venturi effect generated when a thumb is applied to partially cover the end of a hose to enhance the force of the water discharged from the water sprinkler hose, causing the cleaning fluid or air to be directed towards the channel wall with great force. This variable pressure design means that when the cleaning and / or drying element 300 is attached to the navigation element and pulled through or withdrawn through the sight glass channel, the cleaning fluid or air within the channel and between the cylindrical element and the wall of the endoscope channel moves across the variable pressure region between the two cylindrical spheres, generating an injection of cleaning fluid for pressure washing the channel wall of the endoscope channel with the cleaning fluid or an air pressure for drying the channel wall.

[0130] This unique function has a powerful effect of enhancing the cleaning fluid performance by redirecting the fluid from a static interaction point with the wall of the sight glass channel to a dynamic interaction point where the cleaning and / or drying element directs the fluid (or air) towards the wall of the sight glass channel by pressure, thereby enhancing the peeling effect of the chemical agent of the cleaning fluid. In embodiments, by directing the cleaning fluid (or air) towards all of the channel walls by a varying and increasing fluid (or air) pressure, the function of directing the cleaning fluid into any scratches and cracks within the sight glass channel by hydrodynamic force (or air) enables a new and highly effective cleaning performance and / or drying performance that can remove or dry debris, biological substances, and bacteria from the channel, including the ability to handle changes in the surface undulations of the channel, as shown by computational modeling using the mechanics of fluid and pressure for the application of the inverse Venturi principle to generate a variable pressure between two cylindrical elements.

[0131] This technological innovation affects the direction and force of the cleaning fluid or air, and the variable pressure design of the cleaning and / or drying elements converts the fluid from a static detergent infiltration or air into an active pressure cleaning and cleaning and / or drying method that generates a direct and beneficial force of the fluid or air against the channel wall, as indicated by computational modeling and inspection data evaluating the performance of the cleaning and / or drying elements. This pressure cleaning or pressure air drying in the form of hydrodynamic fluid forces or air directed against the channel wall is a measurable force called fluid or air friction.

[0132] In an embodiment, the variable pressure region 306 described above projects the cleaning fluid or air against the channel wall at a pressure greater than the adhesion force of bacteria or moisture that may attach to the wall, creating a powerful advantage not present in existing brushing techniques. This function enhances cleaning in the same way as using a pressure washer with a detergent to remove dirt from the side of a building or sidewalk, or enhances drying in the same way as using an air dryer. This technological innovation improves cleaning fluid or drying in a new and powerful way, and further combines other performances that change the channel cleaning performance into its design so that successful cleaning of the scope 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, the static performance of the cleaning detergent, or drying based on evaporation over time. The variable pressure region 306 of the cleaning / drying element 300 generates a hydrodynamic / air pressure that directs the cleaning detergent / air against the wall of the scope channel. The cleaning operation or drying operation performed in combination with the force by mechanical pressure using the force by hydrodynamic pressure to enhance the performance of the cleaning fluid or air drying is highly consistent, predictable, and reproducible in removing biological substances and debris from the channels of an endoscope or other endoscope instrument or removing moisture by drying without providing damage to these important channels, and is the best way to achieve good results.

[0133] The combination of the cylindrical element and the variable pressure element is important for generating hydrodynamic / aerodynamic forces and adds additional cleaning and / or drying forces by contacting without causing trauma to the sight glass channel. These cylindrical elements add forces due to channel wall contact pressure as an additional cleaning or drying method for removing debris and biological substances from the channel wall or drying, and as complementary cleaning or drying performance cooperating with the variable pressure element between the cylinders.

[0134] When advancing the cleaning element through a lumen having cleaning fluid or air therein, the variable pressure region of the cleaning element is configured to generate a fluid pressure or air pressure against the inner wall of the lumen. In certain embodiments, the variable pressure region is configured to generate a peak pressure of at least about 75 Pa within at least one region between the distal end portion and the proximal end portion of the cleaning element. This peak pressure is preferably at least 100 Pa, more preferably at least 125 Pa. In an exemplary embodiment, the peak pressure is about 150 Pa. This direct pressure against the lumen wall is sufficient to remove substantially all biological substances or moisture from the inner surface of the lumen.

[0135] The variable pressure region of the cleaning element is configured to generate an average or intermediate pressure of at least about 10 Pa, preferably about 20 Pa, more preferably about 30 Pa, over the distance between the proximal end portion and the distal end portion of the cleaning element. In an exemplary embodiment, the intermediate pressure is about 36 Pa.

[0136] The variable pressure region 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, more preferably at least about 8 Pa, within at least one region between the distal end portion and the proximal end portion of the cleaning element. The average or intermediate shear stress over the distance between the proximal end portion and the distal end portion of the cleaning element is greater than at least about 1 Pa, preferably about 2 Pa, more preferably greater than 2.5 Pa. In an exemplary embodiment, the intermediate shear stress is about 2.8 Pa.

[0137] The variable pressure region of the cleaning / drying element is configured to generate a substantially high pressure over a relatively large coverage area between the proximal and distal ends of the cleaning element. This extends the amount of time that the inner surface of the lumen is exposed to the substantially high pressure, thereby increasing the amount of biological material or moisture that can be removed using the device. For definitional purposes, Applicant has defined the peak cleaning pressure coverage area (PPAC™) as the distance between the proximal and distal ends of the cleaning element over which the variable pressure region generates a pressure greater than 50 Pa. In certain embodiments, the cleaning / drying element is configured to generate the PPAC over at least about 10% of this distance, preferably at least about 25% of this distance, more preferably at least about 40% of this distance.

[0138] The variable pressure region of the cleaning / drying element is also configured to generate at least some positive pressure relative to the inner lumen over a relatively large coverage area between the proximal and distal ends of the cleaning element. This extends the amount of time that the inner surface of the lumen is exposed to at least some cleaning or drying pressure, thereby increasing the amount of biological material or moisture that can be removed using the device. For definitional purposes, Applicant has defined the positive pressure cleaning area (+PAC™) as the distance between the proximal and distal ends of the cleaning element over which the variable pressure region generates a positive pressure (i.e., greater than zero). In certain embodiments, the cleaning / drying element is configured to generate the +PAC over at least about 25% of this distance, preferably at least about 50% of this distance, more preferably at least about 75% of this distance. In an exemplary embodiment, the +PAC can be on the order of 81% in height.

[0139] In an embodiment, a contraction ratio can be determined between the contraction section 308 and the throat section 310, and this ratio depends on the diameter of the sight glass channel to be cleaned, the durometer hardness of the material used for the cleaning element 300, the expected values of the speed and force applied to extract the navigation element 301 after being attached 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 desired fluid frictional force of the cleaning fluid or air projected by the cleaning element 300, and whether a thin flow or a thicker flow is desired for the design, and may vary and be different depending on the direction of the flow flowing out of the throat section.

[0140] The total length of the variable pressure region 306 will depend on various factors including, but not limited to, the diameter of the lumen, the viscosity of the fluid or air within the lumen, the specific shape and angles of the contraction section 308, the throat section 310, and the diffusion section 312. In an exemplary embodiment, the length of the variable pressure region is from about 5 mm to about 20 mm, preferably about 10 mm.

[0141] In addition to this, the angle of the surface of the diffusion section 312 can be a single plane or multiple planes. In an embodiment, the angle of the surface of the diffusion section 312 enlarges the space between the wall of the endoscope channel and the cleaning element 300, and in an embodiment, the space within the diffusion section. This variation enables the fluid or air to accelerate and flow out from the throat section to a higher pressure and speed when advancing the cleaning element 300 through the endoscope channel, and generates a force on the wall of the endoscope channel by the increasing pressure of the fluid or air.

[0142] In an embodiment, the cleaning and / or drying element 300 may not have a three-section arrangement, and instead may have other shapes and forms aimed at modifying the pressure between two cylinders and generating a pressure high enough to remove biological substances and debris from the wall of the sight glass channel or to dry the wall of the sight glass channel.

[0143] In an embodiment, the delivery of hydrodynamic or air-drying forces is not a narrow application of high forces caused by the cleaning element 300, but rather is more widespread and thereby has a more successful high force for removing or drying biological material and debris, covering a significant area of the sight glass channel between two cylindrical elements. In certain embodiments, the hydrodynamic force is greater than the adhesion force of bacteria commonly encountered in medical procedures or the adhesion force of moisture to the channel.

[0144] Figures 5 and 6 show the overall flow pattern of fluid or air flowing past the cleaning / drying element 300 within the inner lumen of the endoscope device. As shown in Figures 5 and 6A, the overall pressure distribution between the cleaning / drying element 300 and the inner wall of the lumen creates a relatively low pressure region around the constriction section 308, a higher pressure region around the throat section 310, and an even higher pressure region around the diffuser section 312. The hydrodynamic / air forces are directed at a force level greater than 10 Pa over at least 50% of the distance between the two cylindrical elements 302 and 304. In a preferred embodiment, the hydrodynamic / air forces are directed at a level greater than 10 Pa over at least 75% of the distance between the two cylindrical elements 302 and 304. In an exemplary embodiment, the force is greater than 20 Pa over at least 50% of the distance between the cylindrical elements 302 and 304.

[0145] Figures 5 and 6A also illustrate that peak pressure is formed around the diffuser section 312. As shown, the peak pressure can reach a height of 100 Pa or greater within this region. In certain embodiments, all pressures in the diffuser section 312 are greater than 50 Pa.

[0146] When advancing the cleaning element 300 proximally (or distally depending on the direction of cleaning), the relative velocity of the fluid or air increases from one end of the cleaning / drying element 300 to the other. Further, the diffuser section 312 generates a fluid or air that swirls within it (not shown), thereby increasing the pressure applied by the fluid or air to the inner wall of the lumen.

[0147] Figure 6B further illustrates the viscous shear stress generated by the cleaning / drying element 300 along the inner wall of the lumen when fluid passes between the element 300 and the inner wall. As shown, the shear stress is high near the cylindrical elements 302, 304. The peak shear stress is preferably higher than about 4 Pa, more preferably higher than 7 Pa. In an exemplary embodiment, the peak shear stress reaches about 8 Pa or higher. The average shear stress across all of the inner wall from element 302 to element 304 is preferably higher than about 1.5 Pa, more preferably higher than 2.5 Pa (in certain embodiments, reaching approximately 2.8 Pa).

[0148] In certain embodiments, the distance between the two cylindrical elements is any distance not required for the variable pressure profile between these elements. In an embodiment, this distance can be between 5 mm and 10 mm when the diameter of the sight glass channel to be cleaned is between 4 mm and 4.5 mm. In other embodiments, this distance is expressed as a ratio to the diameter of the sight glass channel, for example, less than 4:1, or less than 2:1, or less than 1.5:1, or other ratios (distance:sight glass channel diameter).

[0149] The diameter of the cylindrical element can be designed to avoid deflection of the proximal and distal portions 302, 304. Deflection of these cylindrical elements can create gaps due to buckling that result in less than ideal cleaning or drying results. This problem is one of the problems with a pull-through cleaner that, despite being about 5.2 mm in diameter, is bound to buckle as it advances through a channel with a diameter ranging from 2.8 mm to 5.0 mm in diameter. In an embodiment, the diameter of the cylindrical element is between 1.0 times and 1.23 times the diameter of the channel to be cleaned or dried to keep the cleaning / drying device 200 centered within the channel such that deflection of the ends of these elements is minimal or limited. In addition to this, a deflection equation can be used to obtain an optimal cylindrical element.

[0150] When the diameter of the cylindrical element is excessively large compared to the channel size, among other problems, there may be ineffective cleaning or drying due to, among other things, the gap within the cylinder, the deflection of the cleaning / drying device, and a resistance that is too large to continuously and consistently withdraw the cleaning / drying device 200 through the channel. The selected material may also affect this result. In an embodiment, this material has a durometer hardness between 35 Shore A and 70 Shore A depending on the size and design of the cylinder, although different and multiple durometer hardnesses can be used within the same device.

[0151] In an embodiment, the dimensions of the cleaning / drying device 200 can allow the forward movement of the cleaner from the distal end without the cleaner getting caught by the elevator of the duodenoscope or endoscopic ultrasound, which is a problem with current bristle brushes and pull-through cleaners, and the dimensions of the cleaning / drying device 200 can allow it to pass through the viewing channel in the opposite direction from proximal to distal.

[0152] In an embodiment, the cleaning and / or drying device 200 can have one or more absorbent sponges disposed in front of or at the end of the cleaning and / or drying element 300 or between one or more of the cylindrical elements to absorb biological substances, debris, and fluids. The absorbent sponge can be of a single cell configuration or have multiple sponges with different cell configurations when providing wiping, absorption, peeling, diffusion attributes of the cleaning fluid, or a combination of these attributes. The absorbent sponge can be made of any material including polyurethane, polyvinyl alcohol, or other absorbent materials. In an embodiment, the sponge is soft and non-traumatic when submerged in a fluid and expands to at least the size of the channel being cleaned, and in a preferred embodiment, is larger than the channel being cleaned. The sponge can be of any shape, including but not limited to cylindrical, helical, conical, triangular, square, or any combination thereof, that fits and aids in cleaning and / or drying the channel of the sight glass. In an exemplary embodiment, the sponge will have a pore size between about 200 PPC and 1500 PPC, preferably between about 200 PPC and about 600 PPC.

[0153] The design of the cleaning device 200 may 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 may also vary based on the target temperature used to submerge the sight glass for cleaning. In an embodiment, the target cleaning temperature is between 25 degrees Celsius and 35 degrees Celsius.

[0154] In an embodiment, the cleaning / drying device 200 can include brushes of various designs that contact a portion of the channel wall in addition to other aspects of the cleaning / drying element 300. The brush can have a length in a ratio of 1.0 times to 1.4 times the diameter of the channel to be cleaned or dried. In an embodiment, the brush is preferably made of a non-abrasive polymer such as polyurethane having a thickness and durometer 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 can be any diameter, but in an embodiment, it can be between 0.5 mm and 2 mm. The brush element can be perpendicular to the navigation element and, in an embodiment, can be part of a separate, shorter navigation element designed to extend only a limited distance within the biopsy channel. This shorter version can be any length for cleaning or drying the initial entry point into the biopsy channel, but in a preferred embodiment, the length is between 4.5 cm and 15 cm. This brush-bearing element can utilize nylon wire bristles or other bristles when arranged in a pattern that is effective for cleaning or drying and minimizes trauma to the viewing channel, regardless of whether it is part of the cleaning element or a separate, shorter version. The gripping element of the brush can have a larger shape at one end or in the center of the element to facilitate introduction into the biopsy channel.

[0155] In certain embodiments, the cleaning and / or drying device 300 can include a plurality of cylindrical elements sandwiching a variable pressure element therebetween, such as a set of five cylindrical elements with a variable pressure element sandwiched between each of the cylinders, for example. These variable pressure elements can be the same or different to produce alternating pressure profiles. The plurality of cylindrical elements sandwiching the variable pressure element can be more or fewer sets than five, depending on what is appropriate for a given application.

[0156] Next, a cleaning and / or drying device 400 having a plurality of cleaning and / or drying elements 300 will be described with reference to FIG. 7B. As shown, each cleaning and / or drying element 300 includes a proximal end portion and a distal end portion 302, 304, and a variable pressure region 306 therebetween, as described above. The proximal end portion and the distal end portion 302, 304 are cylindrical or annular elements having an outer diameter substantially the same as the inner diameter of the lumen to be cleaned (as will be discussed in detail below). In this embodiment, the cleaning and / or drying elements are joined to each other at the proximal and distal end portions. In an exemplary embodiment, the proximal end portion of one cleaning and / or drying element is integrated with the distal end portion of the next cleaning and / or drying element, although it will be recognized that other configurations are possible. For example, the cleaning and / or drying device 400 can have more than one cylindrical element disposed immediately adjacent to another cylindrical element at intervals that do not generate a variable pressure, and then or instead thereof, have a cylindrical element having an interval for generating a variable pressure between the cleaning and / or drying element 300 and the wall of the channel to be cleaned before or after that. In an embodiment, a series of cylindrical elements can be arranged with various intervals for generating a variable pressure between the cylindrical elements and predetermined intervals for generating a constant pressure between the cylindrical elements.

[0157] The cylindrical / annular elements 302, 304 can be manufactured in any shape and size that contacts and at least partially conforms to the wall of the channel to be cleaned. In an embodiment, it includes a cylindrical element with a decreasing or increasing diameter, a cylindrical element that bends to contact each other, a cylindrical element that bends and does not contact another cylindrical element, or a cylindrical element that contacts or does not contact the variable pressure shape between the cylindrical elements. The cylindrical element need not be cylindrical, but it is necessary that it can cooperate with the remaining elements of the cleaning and / or drying device 400 to assist in generating the result of a variable pressure, that is, to accelerate the fluid flow or air flow and thereby promote the generation of a variable pressure region for directing the cleaning fluid or air towards the channel wall by the hydrodynamic or air pressure, having sufficient significant wall contact.

[0158] In certain embodiments, the cylindrical / annular elements 302, 304 can be of any shape that keeps the device substantially centered and prevents the aforementioned flexure, and a preferred embodiment is a cylindrical shape with a reduced-diameter distal end. When the cleaner is drawn around the bends, corners, and junctions of the lumen, this type of inconsistency, which is a problem with existing brushes and pull-through cleaners, generates a situation where the brush and other elements are drawn to one side of the lumen, resulting in minimal, adversely altered, or lost contact between the lumen wall and the cleaning and / or drying elements (whether a brush, pull-through cleaner, or other cleaner), and an adverse effect on the effectiveness of the cleaning and / or drying method. By placing centering elements in front of, behind, or both in front of and behind the device, this problem is corrected, and in particular, more consistent and effective cleaning and / or drying is provided around the bends, corners, channel junctions, and other complex regions inside an endoscope, other endoscope instruments, or endoscope devices.

[0159] The cleaning device 400 can be designed to capture a certain volume of debris or take in a certain level of moisture by drying, relative to the size and level of contamination of the channel to be cleaned. For example, additional cylinders and variable pressure elements can be added to extend the length of the cleaning device 400 to capture more contamination or moisture and remove it. Further, in embodiments, one or more sponges with various pore sizes, diameters, and lengths can be added to improve the removal of contaminants or moisture.

[0160] In embodiments, each cleaning and / or drying element 300 has a length between 2.5 cm and 7.5 cm, and the cleaning and / or drying device 400 includes a plurality of variable pressure zones separated by a plurality of cylindrical elements. In a preferred embodiment, the cleaning and / or drying device 400 includes five variable pressure zones separated by six cylindrical elements. In certain embodiments, the cleaning and / or drying device 400 can include two additional cylindrical elements 402, 404 at its distal end.

[0161] Next, another embodiment of a cleaning and / or drying device having a plurality of cleaning and / or drying elements will be described below with reference to FIG. 7A. As in the case of the previous embodiment, each cleaning and / or drying element 300 includes a proximal end portion and a distal end portion, and a variable pressure region between these end portions, as described above. The proximal end portion and the distal end portion are preferably cylindrical elements having an outer diameter substantially the same as the inner diameter of the lumen to be cleaned (as will be discussed in detail below). In this embodiment, the cleaning and / or drying elements are joined to each other at the proximal end portion and the distal end portion. In an exemplary embodiment, the proximal end portion of one cleaning and / or drying element is integrated with the distal end portion of the next cleaning and / or drying element, although it will be recognized that other configurations are possible.

[0162] In this embodiment, the cleaning and / or drying device further includes one or more substantially cylindrical cleaning and / or drying members 422 positioned at or near its proximal end. The cleaning and / or drying members 422 are substantially cylindrical and thus do not include the variable pressure region discussed above.

[0163] The cleaning and / or drying device can further include a centering element 424 at either or both of its proximal end portion and distal end portion. The centering element 424 serves to center the navigation element 301 and the cleaning and / or drying device when the cleaning and / or drying device is withdrawn or pushed through the lumen around a twist, through corners, and through other complex areas including junctions of a plurality of lumens and internal channels to be cleaned within a sight glass or other instrument. In an embodiment, the centering element 424 can be made smaller than the diameter of the lumen through which the device is advanced, but is large enough to significantly prevent misalignment and deflection of the navigation element 301 to one side or the other of the lumen when the navigation element 301 is navigated, including when the navigation element 301 is withdrawn or pushed around various lumen bends, corners, and junctions (including Y-junctions) simultaneously with the cleaning and / or drying device.

[0164] The centering element 424 can be of any shape that keeps the device substantially centered and prevents this deflection, and a preferred embodiment is a cylindrical shape with a reduced-diameter distal end. When the cleaner is drawn around the bends, corners, and junctions of the lumen, this type of mismatch, which is a problem with existing brushes and pull-through cleaners, creates a situation where the brush and other elements are pulled to one side of the lumen, resulting in minimal, adversely altered, or lost contact between the lumen wall and the cleaning and / or drying element (whether it is a brush, pull-through cleaner, or other cleaner), and an adverse effect on the effectiveness of the cleaning and / or drying procedure. By placing the centering element in front of or behind, or both, the device, this problem is corrected, resulting in a more consistent and effective cleaning and / or drying, particularly around the bends, corners, channel junctions, and other complex areas inside an endoscope, other endoscope instruments, or endoscope devices.

[0165] In some embodiments, the centering element (424) can include a series of shaped elements that project from the elongate member or navigation member. The series of shaped elements can include, for example, struts, spikes, or other protrusions that extend radially outward from the elongate member and are sized to substantially center the elongate member and / or the drying / cleaning element within the internal channel of the endoscope device.

[0166] In a preferred embodiment, the centering element 424 is between 50 percent and 90 percent of the diameter of the lumen to be cleaned, and a more preferred embodiment has a diameter or height between 70 percent and 85 percent of the diameter of the lumen to be cleaned. The centering element 424 can be of any shape that maintains the centering of these elements when the cleaning and / or drying elements are navigated through the channel. In embodiments, this shape includes cylindrical, conical, spherical, and the centering element is particularly suitable for centering the cleaning and / or drying elements when the cleaning and / or drying elements navigate around the curvature of the lumen, when navigating across a Y-junction, and when navigating in other configurations, at the distal region of the device, at the distal and proximal ends, between the cleaning and / or drying members, or at the proximal end.

[0167] Next, another embodiment 800 of the cleaning and / or drying device will be described with reference to FIG. 7C. As shown, device 800 includes a plurality of cleaning and / or drying elements 300 each including a proximal end portion and a distal end portion 302, 304, and a variable pressure region 306 between these end portions, as described above. The proximal end portion and the distal end portion 302, 304 are preferably cylindrical elements having 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.

[0168] The cleaning and / or drying device 800 includes two additional cylindrical elements 402, 404 at its distal end. In certain embodiments, the cylindrical / annular elements 402, 404 can be of any shape that keeps the device substantially centered and prevents the deflection described above, and a preferred embodiment is a cylindrical shape with a reduced-diameter distal end. By placing a centering element in front of, behind, or both in front of and behind the device, this problem is corrected and more consistent and effective cleaning and / or drying is achieved.

[0169] In this embodiment, device 800 further includes a proximal tip element 802 and a proximal cylindrical centering element 804 disposed around variable pressure region 306. Element 804 is preferably disposed around constriction section 308 of pressure region 306 between diffuser section 312 and throat section 310 (see FIGS. 4 and the above description of these elements).

[0170] The centering element 804 is not disposed at the proximal tip of the device (as in the embodiment of FIG. 7B), but rather is disposed around the pressure region 306. The centering element 804 is sized such that its outer surface contacts the inner surface of the lumen of the endoscopic device. When device 800 is withdrawn or inserted through the lumen, the centering element 804 engages the inner surface of the lumen, moving (scrubbing) any biological material on this surface and / or moving (drying) moisture, and moving these materials forward with device 800. If the moved biological material or moisture does not move forward, it is taken up by one of the pressure regions 306 as described above.

[0171] FIG. 27 shows a kit 900 that includes a water cylinder 902 having a straw 904 and a cleaning and / or drying device 910 for the straw 904. In this embodiment, device 910 can be used to clean and / or dry the inner surface of drinking containers and their components, such as drinking straws, beverage containers, water containers, bottles, thermos bottles, syringes, watering cans, glass bottles, baby bottles, water cylinders, and insulated beverage containers, and drinking straws for any of these containers.

[0172] As shown, device 910 includes a plurality of cleaning and / or drying elements 300 each including a proximal end portion and a distal end portion 302, 304 as described above, and a variable pressure region 306 between these end portions. The proximal end portion and the distal end portion 302, 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 joined to each other at the proximal end portion and the distal end portion.

[0173] The cleaning and / or drying device 910 includes two additional cylindrical or annular elements 402, 404 at its distal end. In certain embodiments, the cylindrical / annular elements 402, 404 can be of any shape that keeps the device substantially centered and prevents the deflection described above, and the preferred embodiment is a cylindrical shape with a reduced-diameter distal end. By placing centering elements in front of and / or behind the device, or both, this problem is corrected, resulting in more consistent and effective cleaning and / or drying.

[0174] In this embodiment, the device 910 further includes a proximal tip element 908 and a proximal cylindrical centering element 906 (formed proximal to the most proximal cleaning and / or drying element 300). The tip element 908 preferably includes a substantially cylindrical plug-shaped element that forms the proximal end of the device 910. The tip element 908 serves to guide the device 910 through the straw 904, moving moisture and / or biological material from the inner surface of the straw, thereby cleaning and / or drying these surfaces. In certain embodiments, the device 910 can include a distal tip element (not symbolically shown) having substantially the same design as the proximal tip element 908.

[0175] FIG. 8 shows a system 450 for advancing a cleaning and / or drying device 400 through one or more lumens of an endoscope device. As described above, the cleaning and / or drying device 300 can be coupled to a navigation device 301 that includes, for example, an elongated wire, tube, filament, or similar component that is flexible but has sufficient rigidity to advance through a lumen. The navigation device 301 is coupled to a withdrawal element 454 that can include, for example, a flexible silicone tube or plastic tube having a length sufficient to pass through the entire lumen of an endoscope.

[0176] As shown in FIG. 9, the extraction element 454 can advance the navigation device 301 into the tube, but can be shaped to provide a frictional resistance that makes it difficult for friction to pull the device 301 away from the extraction element 454. In this way, the extraction element 454 is pulled out through the lumen of the endoscope, and the cleaning and / or drying element 300 will follow the extraction element 301 through the lumen.

[0177] As shown in FIGS. 25 and 26, the system can further include guiding elements (750 in FIG. 25 and 760 in FIG. 26) that assist in passing the cleaning and / or drying device 200 through certain difficult areas of the endoscope. In particular, the guiding element prevents the navigation element from bending and entering the wrong channel when passing through an internal junction between a plurality of channels, such as the Y-junction 38B between the suction channel 22 and the biopsy channel 38C. Alternatively, the guiding device can be used to pass the cleaning and / or drying device through a sharp twist or bend within the endoscope lumen.

[0178] During use, the guiding element 750 or 760 can be inserted into one of the internal channels of the endoscope, such as the biopsy channel 38C or the suction channel 22, to assist in passing the cleaning and / or drying device 200 from the distal end of the endoscope 10 to the proximal end of the biopsy channel 38C or the suction channel 22 in a manner that facilitates cleaning and / or drying by moving debris away from the complex and difficult-to-clean distal end of the endoscope in a distal-to-proximal direction.

[0179] Referring now to FIG. 25, the guide element 750 includes a hollow tube, such as a tubular sheath, that can be temporarily inserted into the desired branch of the internal junction between the two channels so that when advancing the guide element 750 through the channel, a portion of the cleaning and / or drying device 200 does not enter or engage within the guide element 750 and bend or enter into the guide element 750 to advance the cleaning and / or drying device 200 into the unintended side of the internal junction or intersection of the internal channels. For example, when cleaning and / or drying the biopsy channel portion 38C of the endoscope 10, when advancing the navigation element of the cleaning and / or drying device 200 from the distal end to the proximal end of this channel (i.e., from the distal end of the shaft 14 to the biopsy valve 38), the navigation element needs to pass through the internal Y-junction 38B to advance back to the final portion of the biopsy channel 38C. In certain embodiments, the guide element 750 may be inserted from the entry point into the biopsy channel 38C to a location past the Y-junction 38B so that the navigation element of the cleaning and / or drying device 200 does not bend at the Y-junction 38B and advance against the suction portion of the endoscope (see, e.g., suction valve 36 in FIG. 1), but instead enters into or engages with the guide element and exits from the end of the biopsy channel 38C.

[0180] In a similar manner, the guide element 750 can be inserted from the suction valve 36 and advanced to a location slightly past the internal Y-junction 38B so that the passage of the navigation element of the cleaning and / or drying device 200 from the distal end of the endoscope to the proximal end of the suction channel occurs without potential bending of the navigation element at the internal Y-junction 38B.

[0181] The guide element 750 can be used to assist in advancing the cleaning and / or drying device 200 around a sharp internal twist within the internal channels of the endoscope, such as at the exit of channel 22 in FIG. 1, as needed, and to assist in advancing the navigation element or the cleaning and / or drying element as needed for other auxiliary purposes.

[0182] In certain embodiments, the guide element 750 is tubular or cylindrical and has an outer diameter smaller than the inner diameter of the internal lumen (e.g., biopsy channel 38), and the internal lumen has a diameter larger than at least the diameter of the navigation element of the cleaning and / or drying device 200. In a preferred embodiment, the guide element 750 is shaped to conform as closely as possible to the diameter of the endoscope channel up to the internal Y-junction 38B or other internal area within the endoscope 10, and the length reaching or extending past the junction 38B can be between 8 cm and 20 cm. Further, in the case of an endoscope having an inner channel with a diameter of 4.2 mm as a preferred embodiment, the outer diameter of the guide element is considered to be between 3.5 mm and 4.15 mm, and the inner diameter is considered to be between 1.5 mm and 4.05 mm.

[0183] In embodiments, the guide element 750 can include a tapered tip to further conform to the shape of the multi-channel internal junction within the endoscope. In embodiments, the proximal end of the guide element 750 can have a flange larger than the inlet opening to the particular endoscope channel into which the navigation element is inserted so as to prevent the navigation element from being fully advanced into the channel, which would make it difficult to withdraw. In an alternative embodiment, the guide element 750 may not have a flange, but can have a marker including, for example, a pad print line or other line defining the boundary of the maximum recommended point of advancement of the navigation element into the endoscope channel.

[0184] FIG. 26 shows another embodiment 760 of a guiding element that includes a substantially circular rod with an inclined distal tip so that the elongated navigation member 301 can be passed back to the aspiration valve opening while being bent from the distal end of the viewing mirror into the biopsy channel 38C at the Y-junction 38B. In the embodiment, the proximal end of the guiding element 760 can have a flange larger than the inlet opening to the particular viewing mirror channel into which the navigation element is inserted so that the navigation element cannot be advanced completely into the channel and as a result, cannot be withdrawn with difficulty. It can also include an inclined cut at its distal end to more faithfully conform to the shape of the multi-channel internal junction within the viewing mirror.

[0185] FIG. 10 shows another embodiment of a cleaning and / or drying device 500 having 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 can include a cylindrical wall contact portion 506 and a variable pressure central portion 508. In this embodiment, each central portion 508 of the cleaning and / or drying elements 502a, 502b includes at least one constricted portion 510 that slopes downward and a throat portion 512 that then slopes upward back toward the lumen wall. As shown, the cleaning and / or drying element 502a also includes a constricted portion and a throat portion and an additional portion 514 that forms two separate variable pressure elements within a single cleaning and / or drying element 502a. The cleaning and / or drying element 502b includes only one variable pressure region, but it will be understood that various combinations of these features can be included. For example, the cleaning and / or drying device 500 can include a plurality of cleaning and / or drying elements, each including a plurality of variable pressure regions. Alternatively, each of the cleaning and / or drying elements can include only one variable pressure region as shown for the cleaning and / or drying element 502b. As in the case of conventional embodiments, combinations of these sections generate variable pressures that induce high shear stress on the wall of the lumen.

[0186] Figures 11A - 11D illustrate other configurations related to the variable pressure regions of the cleaning and / or drying elements. In Figure 11A, the cleaning and / or drying element 560 includes a converging section 562 having an angle between section 562 and the throat 566 that is greater than the angle between the throat section 566 and the diffuser section 564. Figure 11B shows a cleaning and / or drying element 570 that does not include a specific throat section. As shown, the cleaning and / or drying element 570 includes a converging section 572 formed to enter directly into the diffuser section 574 (i.e., inclined with respect to the inner lumen and then inclined inwardly back without having a central cylindrical throat section).

[0187] Figures 11C and 11D show a cleaning and / or drying element 550 that generates multiple high - pressure regions by including more than one throat section 552. Further, each of a series of cleaning and / or drying elements can have a different configuration. As shown, in some cases, one can follow a cleaning and / or drying element having a single throat section with one having multiple throat sections, or vice versa.

[0188] Figure 12 shows yet another embodiment 600 of a cleaning and / or drying device that includes a cleaning and / or drying element 602 and a navigation element 604. In this embodiment, the navigation element 604 includes an injection 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 injection ports 606 for delivering air and / or fluid into the variable pressure region generated by the cleaning and / or drying element 602 within the lumen. Delivering fluid into the variable pressure region increases the pressure within this region, which enhances the fluid or air force against the inner wall of the lumen being cleaned.

[0189] The cleaning and / or drying device 400 can be non-sterilized or sterilized using an appropriate sterilization method including electron beam, gamma, ethylene oxide gas, hydrogen peroxide, or steam. In the event that the device 400 is used for drying, it will typically be sterilized.

[0190] The material for the navigation element 301 can be any material that is sufficient to navigate through the channels to be cleaned and can manage the pulling force associated with advancing the cleaning and / or drying element 300 through the channels to be cleaned. This material includes all metal and polymer-based materials including stainless steel wire, nitinol, and other metals. Further, this material can be in any form including monofilament form, extruded tube, braid, or any other form sufficient to facilitate advancing the cleaning and / or drying element 300 through the channels to be cleaned and includes all polymer-based materials. In a preferred embodiment, the navigation element 301 is a monofilament having a diameter of at least 1 mm and includes nylon, polyamide, polyurethane, PET, or other polymeric material. The navigation element 301 can include a gripping element at one end to facilitate gripping and passing the navigation element 301. In an embodiment, this gripping element is larger than the entry point into the biopsy channel to prevent over-advancing the navigation element 301 into the biopsy channel and losing the gripping force on the navigation element 301.

[0191] In an alternative embodiment, the navigation element 301 includes one or more internal channels that allow for injecting cleaning fluid or air down the navigation element 301 to one or more ports and, optionally, also allow for sucking fluid. Injection ports for discharging the fluid or air advanced by the navigation element 301 can be present in the cleaning / drying device 300, allowing the cleaning fluid or air to be injected into the cleaning device 200 by the navigation element 302, further modifying and increasing the hydrodynamic pressure of the cleaning fluid against the channel walls. In embodiments, the navigation element 301 and the cleaning element 302 can further contain one or more suction channels, which can be used to circulate the cleaning fluid or air more rapidly and / or to forcefully flow fluid through the suction channels to extract debris and fluid or moisture.

[0192] In certain embodiments, the navigation element 301 can be attached to the cleaning and / or drying element 300 by a permanent attachment such as molding, overmolding, two-shot molding, gluing, or other means for creating an attachment where the two elements are fixed or attached for use relative to each other. In a preferred embodiment, the navigation element 301 is separately attachable and, in certain embodiments, attachable and detachable, such that the navigation element 301 can be attached at one end of the channel and removed from the channel at the other end and then attached to the cleaning and / or drying element 300. The attachment means can be any method for the intended use and can include, by way of example, connecting elements, compression fits, slide and locking mechanisms, surface fastener mechanisms, insertion and twisting mechanisms, or deformations and alternative combinations for the diameters and shapes of the navigation element and the cleaning and / or drying element.

[0193] Figures 13 - 15 show three different embodiments for removably attaching a shaft 400, such as a navigation element, to a cleaning and / or drying element 402. As shown in FIG. 13, the cleaning and / or drying element 402 can include a recess 404 for receiving a protruding section 406 of the shaft 400. As shown in FIG. 15, the shaft 400 can include one or more return portions 410 that fit into an opening 412 of the cleaning and / or drying element 402. The shaft 400 can include a flexible section 414 to allow the return portion 410 to fit into the internal lumen of the cleaning and / or drying member 402. As shown in FIG. 14, the shaft 400 can include one or more protrusions 420 that can rotate and enter into a groove on the cleaning and / or drying member 402 to attach the cleaning and / or drying member to the shaft. Those skilled in the art will recognize that the devices and methods disclosed herein are not limited to these embodiments. For example, other methods for coupling the shaft 400 to the cleaning and / or drying element 402 include, but are not limited to, flat monofilaments, wires, strings, or filaments coupled by releasable or non - releasable knots, crimping, press - fit elements, holes, channels, or protrusions that engage other openings, heat staking, heat bending, heat punching, hooks, and snap - type elements.

[0194] In one method according to certain embodiments, the navigation element 301 is advanced through the 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 enzymatic detergent or other cleaning fluid. This fluid serves to initially clean and / or disinfect the lumen to remove at least a portion of the biological material and other pathogens from the lumen. With the distal end portion of the navigation element 302 passed through the distal opening of the lumen, the cleaning element 300 is removably attached to the navigation element 301 by one of the devices and methods described above.

[0195] After attaching the cleaning and / or drying element 300 to the navigation element 301, the navigation element 301 is drawn through the lumen of the instrument. In certain embodiments, the device 200 includes a withdrawal cable configured to draw or advance the elongate shaft 301 within the internal lumen of the endoscope 10. The device can 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 can be manually translated through the internal lumen by a proximal handle or a suitable actuator (i.e., not a motor).

[0196] When the navigation element 301 is drawn through the lumen, each cleaning and / or drying element 300 creates a unique variable pressure region between the proximal end portion 302 and the distal end portion 304. Specifically, the variable pressure region 306 increases the relative velocity between the fluid within each cleaning and / or drying element 300 and the wall of the cleaning and / or drying element 300, thereby accelerating the fluid relative to the inner wall of the lumen, thereby creating a greater fluid force against the wall (as discussed in more detail above). This high fluid force cleans and / or dries more effectively than conventional devices.

[0197] The navigation element 301 can be drawn through the lumen either manually or by a motor as described above. Preferably, the navigation element 301 is drawn at a predetermined speed such as about 20-50 centimeters per second, preferably about 30 centimeters per second. The Applicant has found that withdrawal at this speed optimizes the effect of the variable pressure region 306 on the fluid within the cleaning and / or drying element 300.

[0198] The navigation element 301 can be withdrawn only once, or can be repeatedly advanced and withdrawn two or three times depending on certain cleaning requirements and / or drying requirements. In certain embodiments, 301 is only partially withdrawn through the lumen before being advanced again so that cleaning and / or drying elements do not push biological material and other debris back into the lumen from the proximal portion of the scope (i.e., the biopsy channel).

[0199] A kit is also provided for use in cleaning and / or drying an endoscopic instrument. The kit can include any of the cleaning and / or drying devices described above, and can further include an endoscopic instrument or endoscope such as any of the endoscopes described above with reference to FIG. 1 or others known to those of skill in the art. In addition to or in place of this, the kit can include cleaning brushes, swabs and / or sponges, enzymatic cleaning agents, disinfectants, and other devices and agents for sterilizing and / or disinfecting medical devices, scope desiccants, test strips or other sensors for determining the effectiveness of such cleaning and / or drying devices (i.e., detecting the presence or absence of proteins, biological material, bacteria, fungi, viruses, proteins, ATP or bacterial markers, or other pathogens), personal protective equipment (PPE), e.g., a scope housing for transporting the scope to and from a reprocessing location, and various other devices used in cleaning procedures and / or drying procedures such as contamination bags, in any combination.

[0200] Another kit provided herein includes a cleaning device and a drying device. In certain embodiments, both the cleaning device and the drying device can include one or more of the above-described embodiments. The kit can include a non-sterile cleaning device and a sterilized drying device. Alternatively, the kit can include one device that functions to clean and concurrently dry the inner lumen of the endoscope device. In an embodiment, the cleaning device can be one color and the drying device can be a different color to facilitate the user in differentiating the purpose of each device. This color-coding helps to identify the use of each device and aids in clarifying which device is sterilized after opening. The color difference can be applied to navigation elements, cleaning / drying elements, pad printing lines, or other markers to clarify the different uses of each device.

[0201] In certain embodiments, the kit includes a cleaning device such as one of the above-described embodiments and a drying device that includes an advancing element that can be a filament, wire, tube, or other element having the function of advancing into internal channels that include long, curved, or other channels that are recessed or internal and difficult to access. In an embodiment, this element is gripped at the end after being pulled through the internal channel and can then be pulled through the channel as part of the drying process. Similarly, the advancing element can be advanced by pushing the element from the other end. This element can include versions that can advance air through the device into the channel, including locations within the channel that are removed from the typical effects of forced air drying deep within the channel.

[0202] The drying member can include one or more substantially cylindrical members spaced apart from each other along the advancing member. The cylindrical members are configured to maintain contact with the channel wall to allow any moisture to move and be removed as the advancing element travels through the channel. The advancing element can be advanced by being pushed in, pulled out, or by other means including back-and-forth rocking, pattern-based advancing and withdrawing. The advancing element can proceed through the viewing mirror by connection to any other means of moving the channel drying element through the channel to move, absorb, and / or remove water by an automated or mechanized method or by at least partial direct contact with the surface area to be dried.

[0203] In an embodiment, the drying member can include a series of one or more cylindrical squeegees designed to cause wall contact with the inner wall of the channel to remove fluid and moisture from the channel. These cylindrical squeegees can be arranged in any manner effective to remove fluid and moisture from the channel. This arrangement can include an arrangement of two squeegee groups followed by three squeegee groups or the reverse, or other squeegee configurations, such as one squeegee group followed by two squeegee groups, two squeegee groups followed by four squeegee groups, three squeegee groups and four squeegee groups, four in a row, five in a row, or any other number and configuration of squeegees effective for the removal of water and moisture and depending on the diameter, length, curvature, junctions with other channels, and other factors of the channel.

[0204] In embodiments, some of these skids can be of different heights in order to make the device widely adaptable for use in channels of different sizes by using channels of different sizes. For example, the device can have a skid with a diameter from 5 mm to 5.2 mm, followed by a smaller skid with a diameter between 2 mm and 2.2 mm, and then another skid with a diameter from 3.8 mm to 4 mm to generate variable wall contact across different channel sizes. In embodiments, the height and arrangement of the skids are not limited to this description, and these diameters, arrangements, skid thicknesses, and others can be different based on which is most effective for drying for a given channel drying application.

[0205] The spacing between the skid and any other elements including the drying element can be any spacing that promotes rapid and predictable channel drying, including a spacing of 1 mm, 1.25 mm, 1.5 mm, a spacing between 2 mm, a narrow spacing of 1.25 mm, followed by a gap of 4 mm, and then a spacing between 1.25 mm and 1.5 mm, or other spacings that narrow, widen, or are more variable to optimize and promote rapid and predictable channel drying. The spacing, diameter, alignment, and grouping of the drying elements can, in embodiments, vary based on the channel size, channel material, number of bends when navigating in each direction, number of junctions with other channels, material of the channel dryer if any is present, and other factors unique to a given channel drying application.

[0206] The thicknesses of the skids, disks, and fins can be any thickness that supports channel drying, further dries, and in further embodiments supports the positioning of fins and skids that are to be cleaned. In embodiments, this thickness can include skid and fin thicknesses between 0.2 mm and 0.5 mm, other variations with a thickness from 0.5 mm to 1.0 mm, and other different values including a tapered thickness that is thicker at the base of the skid or fin and tapers as it approaches the channel wall to improve the deflection and conformity of the element to the channel wall while simultaneously providing support around the advancing element and a predetermined rigidity and flexibility.

[0207] In an embodiment, the technological innovation of the present invention includes a centering element such that when the drying element is advanced through the channel to be dried, the drying element remains centered. This element prevents the squeegee or cleaning element from losing contact with the wall of the channel being cleaned and enhances the drying effect. The centering element is of any shape that keeps the drying element centered relative to the channel when advancing the drying element, such that the drying element does not flatten against the wall and lose contact with the channel wall to be dried due to any lateral movement required to navigate through the channel, particularly around bends. In an exemplary embodiment, the cleaning element is between 50% and 95% of the diameter of the channel to be dried or cleaned. The centering element can be placed at any location on the advancing element or on the drying element, and can include multiple centering elements to enhance and maintain the performance of drying and cleaning.

[0208] [Example 1] The applicant has conducted several tests comparing various characteristics of the cleaning device disclosed herein (labeled as Venturi® Cleaner in FIGS. 16 - 18) with the commercially available Pull Thru® Cleaner from Cantel Medical, which is a cleaning brush. The Pull Thru® Cleaner has five cylindrical fins arranged very close to each other, with two of these fins forming a lump with each other, thereby leaving a larger space followed by three additional fins that also form lumps with each other. The fins are a flexible polymer overmolded onto a rod of a rigid material used to advance the cleaner from the proximal end to the distal end of the scope while the scope is submerged in the cleaning fluid. The space between each lump of fins is uniform, and the polymer between the fins is of a thin, uniform thickness overmolded to adhere to the cylindrical monofilament.

[0209] Figures 16 - 18 show the results of these tests. In both cases, fluid was introduced into each lumen of the endoscopic device, and the cleaning device 200 and the Pull Thru® cleaner were advanced through the lumen at an equivalent speed (i.e., approximately 30 centimeters per second). Computational pressure flow modeling was performed to measure the positive pressure cleaning zones of both devices.

[0210] As shown in Figure 16, the Pull Thru® cleaner 700 generated an intermediate 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 (Venturi® cleaner) disclosed herein generated an intermediate pressure of approximately 36 Pa over the length of each cleaning element 300 between the cylindrical elements 302 and 304. Thus, the cleaning / drying device 200 disclosed herein generates a significantly higher intermediate pressure against the inner wall of the lumen than the Pull Thru® cleaner 700. Further, the cleaning device 200 disclosed herein had a peak pressure greater than 50 Pa over a significant portion of the cleaning element 300 (over all of the throat region 310), with a maximum pressure of 150 Pa. In contrast, the Pull Thru® cleaner 700 had a peak pressure greater than 50 Pa in a very small portion of the cleaning element 706 adjacent to the end 704 and had a maximum pressure of only 75 Pa. Thus, the cleaning / drying device 200 disclosed herein generates a peak pressure that is dramatically higher and extends over a longer device length than the Pull Thru® cleaner 700.

[0211] Next, referring to FIG. 17, the Pull Thru® cleaner 700 has a length of approximately 3.85 mm between the proximal end 702 and the distal end 704, and the cleaning / drying device 200 disclosed herein has an average distance of approximately 9.25 mm between the cylindrical elements 302 and 304. The peak cleaning pressure coverage area (“PPAC®”) was considered as the distance within each cleaning element where the pressure of the cleaning fluid or air is greater than 50 Pa. The Pull Thru® cleaner 700 has a peak cleaning area of approximately 0.58 mm or 1.5% of the total distance between the ends 702 and 704. In contrast, the cleaning / drying device 200 disclosed herein had a peak cleaning area of approximately 3.77 mm or 41% of the total distance between the cylindrical elements 302 and 304.

[0212] Next, referring to FIG. 18, the positive pressure cleaning area (“+PAC®”) was defined as the distance along the cleaning / drying element where the pressure of the cleaning fluid or air against the inner wall of the lumen is positive or greater than zero. As shown, the Pull Thru® cleaner 700 had a +PAC of approximately 0.52 mm or 13.5% of the total distance between the ends 702 and 704. The cleaning device 200 disclosed herein had a +PAC of approximately 7.54 mm or approximately 81% of the length between the cylindrical elements 302 and 304. Thus, most of the area between the cleaning / drying device 200 and the inner lumen wall had a positive pressure cleaning pressure.

[0213] [Example 2] The step of cleaning the internal channels of a duodenoscope or other endoscope is an important part of the main manual cleaning steps that must be performed as part of the endoscope reprocessing step to safely and substantially return the reusable endoscope to a usable state. The FDA guidelines regarding this part of the overall reprocessing process preferably include the step of testing either the actual endoscope channels or a representative example using proteinaceous soil with blood. The preferred method is to inject the soil into the channels, evenly disperse the soil, and then leave it until it dries or until the worst-case time frame is reached. Once this state is reached, a channel cleaner is passed through, the channels are rinsed at a level lower than that normally used as part of endoscope reprocessing, and then the contamination level is evaluated.

[0214] The concentrated proteinaceous soil with sheep blood was prepared by Mycoscience, an independent testing agency that prepared and conducted the tests. The protein concentration was 19,421 ug / cm at the upper limit of the duodenoscope channel contamination range. 2 For each test, a 4.2 mm x 180 cm PTFE duodenoscope channel was used, 10 mL of soil was injected into the test channel, the ends of the channel were capped, the channel was rocked back and forth and rotated to evenly disperse the soil within the test channel. The contaminated test channel was left in a container with the ends capped to prevent leakage of soil therefrom for 2 hours. This time is twice the 1-hour limit time used by endoscope manufacturers as a worst-case scenario for reprocessing tests.

[0215] After the 2-hour period ended, the test channel was placed in a container filled with a non-enzymatic cleaning detergent at a concentration recommended for endoscope reprocessing. The endoscope test channel was submerged in the detergent in accordance with the endoscope manufacturer's reprocessing instructions, and then a channel cleaner was advanced through the test channel to clean the contaminated endoscope test channel. The detergent was rinsed out of the endoscope test channel at a level significantly reduced from the amount recommended by the endoscope manufacturer in accordance with FDA guidelines. Next, the endoscope test channel was extracted using 25 mL of extraction medium and the residual protein count was determined.

[0216] To confirm the contamination level, a test was conducted comparing the Pull Thru® endoscope channel cleaner, the Venturi® endoscope channel cleaner, and a positive control test channel extracted without cleaning by the channel cleaner. The positive control indicates that the protein concentration level for this test is 19,421 ug / cm 2 is. The Venturi® cleaner reduced the contamination level to.08 ug / cm 2 in this test. The results for the Pull Thru cleaner reduced the contamination level to 13 ug / cm 2 and were over 162 percent higher.

[0217] Next, referring to FIG. 19, a cleaning / drying device 100 according to another embodiment includes an elongate shaft 102 and a cleaning member 104 disposed on a portion thereof. The shaft 102 can include any suitable material that provides sufficient rigidity to advance itself through the lumen of an endoscope. The elongate shaft 102 has an outer diameter sized to fit within and translate through the internal lumen within the endoscope 10. In this exemplary embodiment, the shaft 102 will have an outer diameter in the range of from about 0.5 mm to about 5 mm, preferably from about 1 mm to 4 mm.

[0218] In certain embodiments, the device 100 includes a withdrawal cable configured to withdraw or advance the elongate shaft 102 within the internal lumen of the endoscope 10. The device can include an energy source and a motor for advancing and / or withdrawing the elongate shaft 102. Of course, it will be recognized that the elongate shaft 192 can be manually translated through the internal lumen by a proximal handle or a suitable actuator (i.e., not a motor).

[0219] Preferably, the cleaning / drying member 104 comprises a flexible material that is fitted into the internal lumen of an endoscope or other endoscope instrument and is designed to absorb or remove any debris or biological material present within the lumen. As shown, the cleaning / drying member 104 has an outer diameter that is larger than the outer diameter of the shaft 102 and is configured to contact the inner surface of the lumen within the endoscope or instrument. The cleaning / drying member 104 comprises a material configured to absorb tissue, biological material, or other debris from at least a portion of the inner surface of the lumen. By removing biological material, tissue, or other debris, and moisture, one potential area for pathogens to survive and proliferate within the instrument is eliminated.

[0220] Preferably, the cleaning / drying member 104 comprises a material that substantially absorbs biological material, tissue, or other debris, and moisture from these surfaces without creating defects such as scratches on the inner surfaces of the instruments. This allows for multiple reuses without gradually making it difficult to clean and / or sterilize these instruments.

[0221] As shown in FIG. 20, preferably, the cleaning member 104 comprises an expandable material that allows the cleaning member 104 to expand from a first position having an outer diameter smaller than the inner diameter of the lumen 50 to a second position having an outer diameter 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 expanded to contact the inner surface 52 of the lumen 50 and absorb biological material therefrom.

[0222] The cleaning / drying member 104 can be expanded by a variety of different means known to those skilled in the art. In an exemplary embodiment, the cleaning member 104 is configured to expand upon absorption of a fluid. In this embodiment, the cleaning member 104 can be advanced through the lumen in a relatively dry state and then absorb fluid within the lumen to allow the cleaning / drying member 104 to expand to a diameter equal to or larger than the inner diameter of the lumen.

[0223] Endoscopic instruments often include tears, scratches, seams, or other irregularities on the inner surface of the lumen (see Figure 3). Preferably, the cleaning / drying member 104 is configured to expand and enter into these tears and irregularities and make contact with the entire surface there. In this way, the cleaning member 104 can absorb biological substances, fluids, or tissues from within these small tears, thereby removing significantly more biological substances from the instrument than conventional cleaning mechanisms.

[0224] The cleaning member 104 can include any material that absorbs biological substances, fluids, or other debris, such as polymers, foams, sponges, bamboo, hemp fibers, microfibers, cotton, or other absorbent fabrics. In one embodiment, the cleaning member 104 includes a spongy 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 that allows the sponge to expand when hydrated. Preferably, the material is selected such that the sponge has the function of expanding at least to the inner surface of the lumen while maintaining sufficient absorbency to absorb a volume of material at least equal to the volume of the segment of the lumen occupied by the cleaning member 104.

[0225] In the embodiment illustrated in Figure 19, the cleaning / drying member 104 extends outwardly from one segment of the shaft 102 such that when the shaft 102 is advanced or retracted through the lumen, the cleaning / drying member 104 absorbs biological substances and moisture from the inner surface of the lumen. Alternatively, the cleaning / drying device 100 can include more than one cleaning / drying member 104 disposed on different segments of the elongate member (see Figure 22A). In an exemplary embodiment, this (these) cleaning / drying member(s) includes a material configured to absorb a volume of material at least equal to the volume of the lumen, either alone or in combination.

[0226] In certain embodiments, the cleaning / drying device 100 further includes a programmable motor (not shown) that can be part of or separate from the elongate 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 can be programmed using a specific algorithm corresponding to certain cleaning or drying objectives. In one embodiment, the motor is programmed to withdraw the elongate shaft 102 at a fixed speed based on a predetermined cleaning or drying time required to completely absorb and remove biological material from the internal lumen. In an alternative embodiment, the motor is programmed to withdraw the elongate shaft 102 in a series of discrete steps, namely, a step of holding the shaft in a specified location for a specified period of time, then a step of withdrawing the shaft by a specified distance, and further repeating these steps until the shaft withdrawal is complete and the cleaning or drying procedure is finished.

[0227] In embodiments, the elongate 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 can be filled or partially filled with a fluid, such as an enzymatic detergent or other cleaning fluid. The fluid serves to initially clean and / or disinfect the lumen to remove at least a portion of the biological material and other pathogens from the lumen. Further, the fluid can be absorbed by a sponge, and the sponge can be expanded outwardly to the inner surface of the lumen. In a preferred embodiment, the sponge will expand to a diameter larger than the inner diameter of the lumen such that the lumen at least partially constrains the sponge. This ensures that sufficient pressure is provided between the sponge and the inner wall of the lumen such that the sponge will expand into any cracks, fissures, or other defects in the wall of the lumen and allow the sponge to absorb and / or remove biological material and fluid from the lumen as the elongate shaft 102 is advanced or retracted through the lumen.

[0228] In one embodiment, the method includes measuring the volume of the lumen and providing a cleaning / drying member configured to absorb an amount of substance at least equal to this volume. This ensures that the cleaning / drying member 104 completely absorbs all fluid, biological material, tissue, or other debris. This lumen volume can be measured by a variety of different methods. In one example, one end of the lumen is sealed so that fluid cannot pass through it, and the opposite end is left open. Next, fluid is delivered into the lumen until the lumen is completely full (i.e., such that any further delivery of fluid results in fluid overflowing from the open end). Next, the fluid is drained into a suitable measuring container, and the volume of the fluid that occupied the lumen is determined.

[0229] With the volume of the target lumen measured, a cleaning / drying member 104 is provided that has the function of absorbing at least a volume of fluid considered to satisfy the lumen. This process can be determined by a variety of different methods. In one example, the cleaning / drying member 104 is completely dried so that it contains substantially no fluid therein. Next, the dried cleaning member 104 or sight glass is placed into a container containing a large volume of fluid that has already been measured. The cleaning member 104 is left to absorb fluid until it is completely saturated, and the difference in the fluid volume within the container provides the maximum absorption function of the cleaning member.

[0230] After the cleaning member 104 has passed through the entire lumen, air is injected into the lumen to sweep any remaining disinfection solution from the lumen and dry the lumen. To facilitate drying, an alcohol such as 70% ethyl alcohol or isopropyl alcohol can be delivered into the lumen.

[0231] Next, another embodiment will be described below with reference to FIG. 21B. As shown, the cleaning / drying member 108 extends outwardly from the shaft 102 substantially along its entire length 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 longer than the length of the lumen to be cleaned and dried. Preferably, the cleaning / drying member 104 includes a material configured to absorb at least a volume of material equal to the internal volume of the lumen.

[0232] The cleaning / drying member 104 can perform the function of centering the elongate shaft 102 within the inner lumen of the scope 10. Alternatively or in addition, the shaft 102 can further include a centering device (not shown) at its distal end to keep the cleaning / drying device 104 optimally positioned within the lumen such that absorption of biological material is substantially uniform through the lumen of the scope 10.

[0233] The cleaning device 100 can include one or more sensors (not shown) along the shaft 102 for detecting biological material, pathogens, liquids, or other particulate matter within the endoscope 10 or other device. Suitable sensors can include PCT and microarray-based sensors, optical sensors (e.g., bioluminescence and fluorescence), piezoelectric sensors, potentiometric sensors, amperometric sensors, conductivity sensors, or nanosensors, among others. The shaft 102 can further include an indicator, such as a display, configured to be coupled to the sensor and indicate the presence or absence of biological material, pathogens, liquids, or other particulate matter detected by the sensor. The indicator can be any suitable chemical indicator that has been confirmed to be effective for cleaning procedures and / or sterilization procedures and that causes a physical or chemical change visible to the human eye after exposure to certain parameters. The indicator and the sensor can be part of the same device or separate from each other.

[0234] In another aspect, some embodiments can include the function of injecting a disinfectant, cleaning chemical, or other fluid to achieve an additional sterilizing effect before the cleaning member 104 or with respect to the absorption of biological substances. The fluid can be for the purpose of facilitating the withdrawal of the elongated shaft 102 and the cleaning member 104 through the lumen, or for acting as a disinfectant, or for other reasons including prolonging the half-life of the chemical agent to achieve other advantages, and can function to lubricate the lumen.

[0235] Next, another embodiment will be described below with reference to FIGS. 22 and 23. As shown in FIG. 22, the cleaning / drying device 200 includes an elongated shaft 202 and a cleaning / drying member 204 disposed at its distal end portion. Similar to the previous embodiment, the shaft 202 can include any suitable material that provides sufficient rigidity to advance the shaft 202 through the lumen of the endoscope. The elongated shaft 202 has an outer diameter sized to fit within and translate through the internal lumen within the endoscope 10. In this exemplary embodiment, the shaft 202 will have an outer diameter in the range of from about 0.5 mm to about 5 mm, preferably from about 1 mm to 4 mm.

[0236] The cleaning / drying member 204 has an outer diameter larger than the outer diameter of the shaft 202 and is configured to contact the inner surface of the lumen. The cleaning / drying member 204 includes a material configured to remove tissue, biological substances, or other debris from at least a portion of the inner surface of the lumen. By removing biological substances, tissue, or other debris and moisture, one potential area for pathogens to survive and proliferate within the instrument is eliminated.

[0237] Preferably, the cleaning member 204 includes a material having a roughness defined to substantially remove biological substances, tissue, or other debris from these surfaces without creating defects such as scratches on the inner surface of the instrument. This allows for multiple reuses without gradually making it difficult to clean and / or sterilize these instruments.

[0238] The cleaning / drying member 204 includes an outer surface 210 that comprises a material that is smooth enough to minimize or completely avoid creating any scratches or other defects in the plane of the lumen of the endoscopic instrument. Conventional endoscopes and other endoscopic instruments typically include materials such as PTFE and silicone that have high flexural strength, water resistance, and a low coefficient of friction. Accordingly, the outer surface 210 comprises a material that has sufficient durometer hardness and / or roughness to clean biological material, tissue, and other debris from the surface of these materials while minimizing scratching or otherwise damaging these materials.

[0239] In the above-described embodiment, the cleaning / drying member 204 has a substantially annular cross-sectional shape that is designed to conform to the outer peripheral shape of the inner lumen of the endoscopic instrument. However, it will be understood that the cleaning / drying member 204 can have a variety of different shapes and configurations. For example, the cleaning / drying member 204 can be rectangular, triangular, circular, oval, and square, among others. Further, the cleaning / drying member 204 can include surface undulations such as protrusions, bristles, returns, or roughened areas to facilitate cleaning / drying of the inner surface of the lumen. However, it will be understood that in embodiments, any such undulations or bristles can be designed with a material similar to the overall cleaning member or with a plurality of different materials.

[0240] In one embodiment, the cleaning / drying member 204 has an outer diameter that is larger 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 such that when the shaft 202 is advanced or retracted through the lumen, the cleaning / drying member 204 removes biological material from the inner surface of the lumen. Alternatively, as shown in FIG. 24, the device can include more than one cleaning / drying member 204 disposed on various portions of the shaft 202. In other embodiments, the cleaning / drying member 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.

[0241] All issued patents, published patent applications, and non-patent publications mentioned in this specification heretofore are hereby incorporated by reference herein for all purposes to the same extent as if the entire contents of these documents were individually and specifically incorporated by reference.

[0242] Although some embodiments of this description are shown in the drawings, this description is not intended to be limited to these embodiments, as it is intended to cover a scope as broad as that permitted by the relevant art and as the specification is to be read. Those skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting, exemplary embodiments. Features exemplified or described with respect to one exemplary embodiment can be combined with features of other embodiments. Those skilled in the art will be able to devise various alternatives and modifications without departing from this description. Accordingly, this description is intended to cover all such alternatives, modifications, and variations. Further, those skilled in the art will recognize additional features and advantages of this description based on the above-described embodiments. Accordingly, this description is not limited by what is specifically shown and described, except as indicated by the claims.

Description of Reference Numerals

[0243] 10 Endoscope 12 Proximal handle 14 Elongated shaft 16 Fluid delivery system 30, 32, 34 Internal lumen

Claims

1. A drying device, An elongated member configured to advance through the lumen of the device, A drying member comprising at least one member attached to a portion of the elongated member, including a distal end portion and a proximal end portion, and a central portion between the distal end portion and the proximal end portion, Includes, The central portion is shaped to generate a pressure gradient along the central portion from the distal end portion to the proximal end portion. Drying device.

2. The drying device according to claim 1, wherein the pressure gradient causes an increase in the relative velocity between the drying member and the fluid and air in the lumen as the drying member moves forward through 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 central portion of the drying member includes a shrinkage section coupled to the proximal end portion, a diffusion section coupled to the distal end portion, and a throat section connecting the diffusion section and the shrinkage section. The throat section has a diameter 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. The drying device according to claim 1.

5. The contraction section has an increasing diameter from the proximal end portion to the throat section, and the diffusion section has a decreasing diameter from the throat section to the distal end portion. The throat section is substantially cylindrical. The drying device according to claim 4.

6. The drying device according to claim 4, wherein the shrinkage section determines an angle with respect to the throat portion, which is between approximately 4 degrees and approximately 85 degrees.

7. The drying device according to claim 4, wherein the diffusion section is angled with respect to the throat portion, which is between approximately 4 degrees and approximately 85 degrees.

8. The drying device according to claim 1, wherein the drying member includes first and second cylindrical centering elements positioned on either end of the drying member, for centering the drying member as it advances through the lumen.

9. The present invention further includes a second drying member coupled to the second portion of the elongated member, and a third drying member coupled to the second drying member, Each of the first and second drying members includes a distal end portion and a proximal end portion, and a central portion between the distal end portion and the proximal end portion, The central portion is shaped to generate a pressure gradient along the central portion from the distal end portion to the proximal end portion. The drying device according to claim 1.

10. A drying device for use with endoscopic instruments, A slender member configured to translate through the lumen inside the endoscopic instrument, At least one drying element attached to a portion of the elongated member, wherein the 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 the central portion has an outer diameter smaller than that of the proximal end portion and the distal end portion, Includes, The central portion is shaped to increase the force applied to the inner wall of the lumen by the fluid inside the lumen as the cleaning member advances through the lumen. Drying device.

11. The drying device according to claim 10, wherein the force generates a pressure of at least about 100 Pa in at least one area between the distal end portion and the proximal end portion of the cleaning element.

12. The drying device according to claim 10, 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.

13. The drying device according to claim 10, wherein the force generates an average pressure of at least about 10 Pa between the proximal end portion and the distal end portion of the cleaning element.

14. A drying device for use with endoscopic instruments, A slender member configured to translate through the lumen inside the endoscopic instrument, At least one drying element attached to a portion of the elongated member, wherein the drying element includes a distal end portion and a proximal end portion, and a central portion between the distal end portion and the proximal end portion, Includes, The central portion includes a first section connected to the proximal end portion, a second section connected to the distal end portion, and a third section connecting the first and second sections, wherein the third section has a diameter smaller than the diameters of the proximal and distal end portions and larger than the diameters of the first and second sections. Drying device.

15. The drying device according to claim 14, wherein the first section tapers inward from the second section to the proximal end portion.

16. The drying device according to claim 14, wherein the third section tapers inward from the second section to the distal end portion.

17. The drying device according to claim 14, wherein the distal end portion includes a fin having a cylindrical element having a diameter substantially equal to or greater than the inner diameter of the lumen and a tapered section that tapers inward from the cylindrical element to the third section.

18. It's a kit, A beverage container including a drinking straw, A slender member configured to advance through the lumen of the drinking straw, A cleaning member comprising at least one member attached to a portion of the elongated member, including a distal end portion, a proximal end portion, and a central portion between the distal end portion and the proximal end portion, Includes, The central portion is shaped to generate a pressure gradient along the central portion from the distal end portion to the proximal end portion. kit.

19. The central portion of the cleaning member includes a shrinking section coupled to the proximal end portion, a diffusion section coupled to the distal end portion, and a throat section connecting the diffusion section and the shrinking section. The throat section has a diameter 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. The kit according to claim 18.

20. The contraction section has an increasing diameter from the proximal end portion to the throat section, and the diffusion section has a decreasing diameter from the throat section to the distal end portion. The throat section is substantially cylindrical. The kit according to claim 19.

21. The cleaning device further comprises a tip element having a substantially cylindrical shape and being sized to advance through the lumen of the drinking straw, according to claim 18.

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