JP2025516557A - SYSTEM AND METHOD FOR A DRYING AND/OR CLEANING DEVICE - Patent application - Google Patents

Abstract

Provided are devices and methods for cleaning and/or drying devices such as drinking straws for beverage containers, medical devices, endoscopic instruments, and the like. A desiccant device for use with an endoscopic instrument includes an elongate member configured to advance through an internal lumen within the endoscopic instrument and a desiccant member removably coupled to a portion of the elongate member. The desiccant element includes a variable pressure region shaped and configured to increase the hydrodynamic fluid frictional forces and fluid pressures applied to the walls of the internal lumen of the endoscope to more effectively remove all moisture and fluids from the interior surface of the endoscopic instrument.Selected Figures

Description

The present invention relates to a system and method for a drying and/or cleaning device.
CROSS-REFERENCE TO RELATED APPLICATIONS
This application claims the benefit of U.S. Patent Application No. 17/739,146, filed May 8, 2022, which is a continuation-in-part of U.S. Patent Application No. 17/509,304, filed October 25, 2021, which claims the benefit of U.S. Patent Application No. 63/105,072, filed October 23, 2020, the entire disclosure of which is incorporated by reference herein for all purposes.

Endoscopes are used and reprocessed many times each day to deliver highly advanced optical performance, consistent real-time image transmission, predictable endoscope handling, and other functions critical to successful diagnosis and treatment of clinical conditions. This also occurs in non-medical applications involving the inspection, cleaning, and repair of remote locations using non-medical endoscopes. This includes, by way of example and not limitation, remote visualization of hydraulic lines, oil field pipelines, refinery lines and lumens, sewer and water lines, internal areas of combustion engines, and other non-medical applications involving remote visualization of areas that would benefit from remote access and evaluation.

Endoscopes are high technology instruments that typically have a sophisticated and expensive optical tip at the distal end of the scope to facilitate excellent visualization. These image signals are captured on the tip 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 translated through software and processors and projected at many frames per second onto an image screen, console, or other means of transmitting the image from the optical tip to a remote user.

The superior imaging capabilities of endoscopes have enabled many advances in medical and non-medical fields. This is due in significant part to the combination of superior optical performance and scope handling coupled with the reusability of almost all endoscopes. This powerful combination allows advanced, high quality optical elements to be made available at a moderate per-use cost due to the ability to clean, disinfect (when applicable), and reuse endoscopes with their advanced optical capabilities. The ability to reuse these scopes essentially spreads the high cost of endoscopic capabilities over multiple procedures/uses, thereby allowing reasonably low-cost access to cutting edge technology for multiple beneficial uses on a global scale. Endoscopes with these advanced optical capabilities are too expensive to be used once and then discarded. In addition to this, the environmental impact of discarding the advanced electronics that facilitate the functionality of the endoscope is not negligible, unjustified, and unsafe for the environment. Reusable scopes provide a way to make maximum optical capabilities available for a variety of procedures that would otherwise be unable to bear the cost of using such technology.

While reusable scopes have offered considerable advances and capabilities, recent concerns have arisen regarding their ability to consistently and predictably clean and thereby remove all dirt and biological material that contaminates the endoscope during use. A successful cleaning step is an important step to support disinfection and/or sterilization (when applicable) in order to reprocess these scopes for their next use. The step of cleaning non-medical scopes is also important to avoid the performance of the scope being hindered upon subsequent use by retained material that may accumulate and adversely affect the scope's performance. This applies to both non-robotic scopes and those that are connected to or otherwise used in conjunction with robotic technology to view, navigate, and, when applicable, treat using remote visualization.

Several contamination-related reprocessing issues leading to potential patient infections and/or scope performance issues have been noted with these scopes. These include issues due to concerns regarding the cleanliness of the reusable valves used to facilitate suction and air/water squeezing, the presence of residual material that cannot be consistently removed from the composite distal ends of certain scopes (particularly duodenoscopes and ultrasound endoscopes), and successful cleaning of the long biopsy/working channels within certain scopes that are critical for passing instruments to the distal end of the scope.

Nearly all of these issues are addressable through the use of new, relatively low-cost technologies and practices that were generated in response to these concerns and that can be applied in the context of the economic implications of current workflows and procedures, and that are environmentally friendly, especially when compared to single-use endoscope options. These relatively low-cost technologies and practices include the use of single-use disposable tubing and disposable valves instead of reusable tubing and valves, the use of sterile single-use endoscope shields that seal an area of the composite distal end of the endoscope during use and initial pre-cleaning instead of leaving this area open and exposed to contamination, the use of forced air drying, improved compliance with reprocessing procedures, and the implementation of post-procedure cultures and monitors to address other areas of concern.

With all these advances, the remaining area to be addressed is the cleaning of the internal lumen of the endoscope. During medical procedures, the internal biopsy and suction channels become heavily contaminated with bacteria, biological material, and debris through the passage of multiple instruments through the biopsy channels and through the actuation of suction to remove mucus, debris, and other material that may impede the physician's visualization during the procedure. All of these activities provide benefit to the patient by delivering therapy in a minimally invasive manner through the scope, but in parallel with these beneficial activities, the scope suffers from heavy contamination of these channels, which must then be substantially cleaned and restored for use on the next patient (or non-medical application) without exposing the next patient (or non-medical application) to the risk of scope-related infection (or poor performance, a dirty non-medical scope). It is known that without successful cleaning, endoscopes cannot be successfully disinfected or sterilized. Unremoved biological material and debris act as a shield for pathogens, protecting them from being killed by the disinfectants and sterilants used to reprocess the scope. In addition, unremoved biological material and pathogens create an opportunity for microorganisms to attach to the inner surface of the endoscope, participate in replication, and form biofilms, which make the removal of these microorganisms particularly difficult, and which in turn creates a risk of transmission of multidrug-resistant infections through the endoscope. The biofilms can replicate, detach, then attach to new locations, and repeat the process, while also incorporating other microorganisms into the biofilm during this process, generating additional multidrug-resistant microorganisms (MDROs) that cannot be effectively treated with antibiotics. MDRO infections are exceptionally dangerous and have caused numerous deaths worldwide from contaminated endoscopes that have not been successfully reprocessed.

In the current Covid-19 pandemic, the importance of successful clearing has become even more pronounced. It is now well established that Covid-19 infection begins in the lungs but rapidly migrates to the gastrointestinal tract, where viral replication occurs in these organs before detectable symptoms. A significant number of endoscopic procedures involve the use of endoscopes, including, by way of example and not limitation, to examine and treat pulmonary pathologies (e.g., bronchoscopy using specialized endoscopes called bronchoscopes) and to diagnose and treat gastrointestinal pathologies (e.g., the use of gastroscopes, duodenoscopes, ultrasound endoscopes, and colonoscopes), increasing the likelihood that the Covid-19 virus may become encapsulated in biofilms resulting from incomplete clearing of the endoscope, which in turn may progress to drug-resistant strains of Covid-19 that may be transmissible to subsequent patients. In light of all of these concerns, new technological innovations are needed that significantly improve the efficacy and predictability of successful clearing of the lumen of the endoscope.

Current Cleaning Practices and Techniques Current endoscope channel cleaning practices utilize certain cleaning techniques that can increase variability and also have a potentially detrimental effect on the success of cleaning the endoscope channel. The most commonly used cleaning technique 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 with other internal channels as well. This action must be performed while the scope is submerged in the cleaning fluid, with the intention that the mechanical action of the wire bristles removing biological material and debris is after the scope is immersed in the cleaning fluid.

With this action, after the wire bristle brush is dipped into the distal end of the biopsy channel, the individual performing the cleaning is to inspect the brush for any visible signs of debris and, if any debris is noticed, repeat this action until no visible debris is noticed on the brush. The goal with 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 briefly dipping the scope in a cleaning fluid intended to loosen contaminants before passing the brush.

Limitations of the Current Approach Current endoscope channel cleaning approaches have several notable limitations that increase the variability of cleaning results and have an overall negative impact on the success of cleaning endoscope channels. The first problem is that current cleaning approaches involve advancing a cleaning brush from the proximal end of the scope at the opening of the biopsy channel down the channel to the distal end of the scope where the instrument exits the scope into the patient's body. This approach 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 complicated part of the scope to clean, to the distal tip of the scope, which is the most complicated part of the scope to successfully clean and reprocess, and the area linked to most scope-related infections and deaths. In essence, the cleaning brush acts as a tool to not only partially remove debris within the channel, but also to scrape or push contaminants out of the biopsy channel into the area on the scope that is most difficult to clean and has the highest level of risk for scope-related infection. Logically, one would want to do everything possible to do the opposite of what is currently done with regard to the direction for passing the cleaning brush through the biopsy and suction channels (i.e., from the distal end of the biopsy channel to the proximal end exit). This current approach of using a brush is also done with certain compound scopes, such as duodenoscopes, due to limitations with current technology, including, by way of example and not limitation, a demonstrated problem where the compound distal end of the scope results in the wire bristle brush getting stuck at the distal end and being unable to advance therefrom to clean the biopsy/working channel of the scope.

In addition to this limitation, the cleaning brush itself has some notable limitations that inhibit consistent and repeatable successful scope reprocessing. Photographs of the interior of the scope biopsy channel after the cleaning step with a nylon wire bristle brush reveal that the bristles flex while being passed through the channel, leaving streaks along the interior of the channel rather than a clean and consistent cleaning result. These channels can become heavily contaminated with debris, biological material, and bacteria after being subjected to repeated passes of therapeutic instruments during the procedure, and also from the actuation of suction that removes debris, mucus, and other biological material during the procedure. Using a brush that flexes and causes streaks means that 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 as recommended by scope manufacturers do not eliminate this problem and do not result in predictable, completely clean channels. Instead, the combination of repeated passes with a hard bristle brush causes damage to the surfaces of the internal endoscope channel as the bristles generate scratches and tears from the impact of multiple wire passes. These scratches and tears allow bacteria and biological material to enter and colonize these new spaces despite multiple brush passes cleaning the scope after the next case, limiting the consistency of cleaning results and thereby inhibiting the ability of disinfectants and sterilants to successfully disinfect and sterilize the scope to make it safe to return for use in the next case. All biological material and debris must be successfully removed for successful disinfection and reprocessing of the scope. The biological material and debris that is left behind acts as a shield over pathogens (including bacteria naturally occurring from the patient) that may colonize within these channels, preventing successful treatment with disinfectants and sterilants that kill the pathogens and make the scope safe for reuse by the next patient.

In relation to this situation, it is hypothesized that the person cleaning the scope will engage in repeated wire bristle brush passes. Although the scope manufacturer's instructions instruct the individual cleaning the scope to pass the wire bristle brush until there is no visible debris, given the deflection of the bristles, the absence of visible debris is not clear evidence that the brush pass resulted in successful cleaning. In addition, it is not clear that all individuals involved in cleaning with wire bristle brushes will always engage in repeated brush passes (in addition, visual inspection is not entirely accurate). A device that can substantially clean the biopsy channel in a single pass would be a significant way to remedy these problems.

An additional problem concerns 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 predictable passage of instruments and typically has a low coefficient of friction to aid in instrument passage. The channel accommodates a wide range of instruments, and the diameter of the instrument passed is significantly smaller than the diameter of the biopsy/working channel of the endoscope, providing space for safe advancement of the instrument through the channel. However, sometimes instruments are not used properly, such as attempting to open the biopsy forceps in the biopsy channel or attempting to pull the biopsy forceps back through the channel without the forceps properly closing. When this occurs, scratches, dents, or tears can be introduced into the biopsy channel, which in turn increases the difficulty of achieving successful and predictable removal of biological material and debris when cleaning the biopsy channel. There is no evidence that wire bristle brushes can remove debris from damage to the biopsy channel in a predictable and consistent manner. Recently published data from a national survey indicates that current methods of cleaning the biopsy channel for two combined specialty endoscopes, duodenoscopes and ultrasound endoscopes, fail to remove biological material and debris in up to 15% of cases.

An alternative technology to nylon wire bristle brushes is the pull-through brush cleaner, such as the Pull Thru® cleaning brush manufactured by Cantel Medical. The pull-through brush cleaner has five cylindrical fins placed very close together, designed so that two of the fins form a cluster with each other, followed by a larger space, and then three additional fins form a cluster with each other. The fins are a flexible polymer overmolded onto a rod of harder material that is used to advance the cleaner down the endoscope biopsy channel from the proximal end to the distal end of the endoscope while the endoscope is submerged in the cleaning fluid. The space between each cluster of fins is uniform, and the polymer between the fins is of a thin, uniform thickness that is overmolded to adhere to the cylindrical monofilament. The advantage of the pull-through cleaner is that it causes less trauma to the walls 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.

However, pull-through cleaning brushes have several drawbacks. Like wire bristle brushes, pull-through cleaning brushes are designed to pull debris from the proximal end of the biopsy channel of the scope to the high-risk and difficult-to-clean distal end, increasing the likelihood of contamination of the distal end when attempting to clean the biopsy channel of the scope. An additional limitation 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, which creates a buckling effect that results in a gap between the fin and the biopsy channel. This gap or lack of consistent wall conformance can mean that not all potential contaminants are addressed as the pull-through brush is moved through the biopsy channel. In addition to this, the gap means that changes in the surface of the wall of the biopsy channel, such as changes due to scratches or tears from the passage of an instrument, are unlikely to be addressed by the pull-through brush as it is moved through the biopsy channel. The fins are unable to affect scratches and tears as the fin passes over damage to the channel wall.

An additional limitation that exists with all of the techniques used to clean the internal lumens of endoscopes is the lack of a synergistic or complementary element between the two techniques used in the cleaning phase. All reusable endoscope manufacturers require the endoscope to be placed in a fluid formulated to aid in the removal of biological material and debris as the first step of the cleaning process, followed by a second step of brushing the internal channels while the scope is submerged in the cleaning fluid. While there are multiple formulations of cleaning fluids, the most commonly used are either enzymatic cleaners or pH-neutral non-enzymatic cleaners. These cleaners are intended to loosen biological material and bacteria adherent to the walls of the channels, but there is evidence that they are ineffective on their own and that not all biological material is consistently removed, even with the addition of brushing.

One significant limitation of this current approach is that the cleaning fluid and brushing application are independent techniques used together (i.e., the scope is submerged in the cleaning fluid while the channel is brushed), but these techniques are not designed to actively complement and enhance each other's effectiveness. New innovations are needed that address the significant limitations of the current brushing technology and that can actively complement and work in conjunction with the cleaning fluid used in this critical cleaning step in reusable endoscopes. New innovations are needed 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.

Another important need that is not met in the instruments and processes described above is the downstream problems associated with drying instruments after the cleaning and/or disinfection or sterilization process is completed. Most, if not all, disinfection or sterilization procedures include an element of delivery of a disinfectant or sterilant, either liquid or gas, followed in most protocols by rinsing with an agent such as water or sterile water, or in very limited cases evaporation of the agent.

In all of these processes, the critical final step after disinfection or sterilization is the drying step of the instrument. For the exterior surfaces of the medical device, this aspect of the process is somewhat simple, but for recessed areas, especially the relatively narrow and sometimes long channels, drying these areas is difficult, time consuming, and not predictable or consistent. Failure to substantially dry negates the benefits of the entire reprocessing approach, including the disinfection and/or sterilization steps, because wet surfaces promote the growth of pathogens and biofilms. When instruments are dry, pathogens and biofilms cannot grow. Hydration is a central component in the growth of pathogens and biofilms, leading to hospital-acquired infections, drug-resistant infections, and other deadly infections. In non-medical applications, residual hydration promotes the growth of biofilms and pathogens that can affect device performance and even ultimately expose the user to one or more pathogens.

Current drying techniques have applied several inconsistent and variable methods that do not provide consistent assurance that the moisture within the channels and invaginated areas has been removed and that the remote and/or invaginated areas are therefore dry. Attempts have been made without success to simply suspend the device vertically to position the wet channels so that the water inside the channels will eventually run off and evaporate due to the effect of gravity. This approach has been disproved by evidence that these channels do not consistently remain completely dry even after several days in this position.

Attempts to overcome these problems have included rinsing these channels with alcohol under the premise that this will accelerate drying and may act as a supplemental bacteriostatic agent (although medical instruments are already disinfected or sterilized at this point). Data indicates that this does not appreciably accelerate drying time or effectiveness, and may in certain cases prolong the drying process. Additionally, there is concern that the use of alcohol may allow certain bacteria and pathogens that are otherwise inactive or harmless to colonize within the channels, which may then be transmitted to the patient or user.

Other techniques include using air drying, which is inherently difficult, time consuming, and variable due to the indented and sometimes narrow channels that must be dried. Certain of these channels are 4 to 6 feet long and have diameters of only a few millimeters or less. Drying techniques include directing compressed air into or through the channels to enhance drying, or suspending the instruments in cabinets where air is circulated using motor-driven fans that blow air into small spaces. These techniques include a specific technique called "forced air drying" that filters air blown through tubing into small areas such as endoscope channels by motor-driven fans. Even these more aggressive and targeted techniques have variable results, due at least in part to the distance the air must travel to dry the channels, the potential for changes in channel diameter that affect the velocity of the air, and the surface tension of water, which in many ways is greater than the force of air and prevents effective and timely water removal. In addition, the narrow spaces inherently aid in water capture or retention, promoting a moist environment and inhibiting evaporation. Beyond these significant difficulties are challenges, including endoscopes and other instruments that have curved internal channels, creating more variable surfaces such as Y-junctions and connectors where one or more channels may come together and collect water, as well as areas adjacent and/or outside of valves that interact with the channels.

It would therefore be desirable to provide improved systems and methods 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 would be desirable to provide a device that can substantially clean and/or dry all interior surfaces of the endoscopic technology, including crevices, Y-junctions, and scratches or other irregularities, without further damaging them.

Devices and methods are provided for cleaning biological material, tissue, or other debris from endoscopic instruments, such as endoscopes, and particularly from internal lumens or other spaces within endoscopic instruments. Devices and methods are also provided for drying the internal lumens of these endoscopic instruments after they have been cleaned, and for testing to verify successful cleaning and drying. The methods and devices disclosed herein can be used with or incorporated into a variety of different reusable or disposable endoscopic instruments and devices, including internal lumens or other spaces, such as endoscopes, trocars, cannulas, dilation devices, Foley catheters and other indwelling catheters, guidewires, central venous catheters, bipolar or monopolar electrosurgical or ultrasound devices, arterial lines, drainage catheters, peripherally inserted central catheters, endotracheal tubes, feeding tubes, pulmonary ventilators, dialysis machines, continuous positive airway pressure (CPAP) machines, perfusion machines, infusion pumps, ventilators, robotic and non-robotic surgical devices, and other devices that are deployed, penetrated, and/or guided into the body. The dimensions of the cleaning and drying devices disclosed herein will, of course, be adjusted to suit the size of a particular implement or device.

For example, the methods and devices disclosed herein can be used to clean and/or dry components of a CPAP machine, such as hoses, tubes, headgear, filters, humidifiers, masks, and/or air entrainment valves, flow-dependent resistance devices, pneumatically actuated air sources, and venturi flow drivers.

The methods and devices disclosed herein can be used to clean and/or dry the interior surfaces of drinking containers and their components, such as drinking straws, drinking containers, water containers, bottles, thermoses, suction cups, water jugs, glass bottles, baby bottles, water bottles, and insulated drinking containers, and drinking straws for any of these containers. For example, the devices described herein can be used to clean and/or dry the interior surfaces of drinking straws from water bottles and/or the water bottle itself. In some cases, the devices disclosed herein are incorporated into these drinking containers as kits.

The innovations of the present disclosure address several limitations associated with current techniques for cleaning and/or drying lumens or channels and provide new and significant capabilities for enhanced cleaning and drying performance. In some embodiments, the devices disclosed herein eliminate significant shortcomings associated with current channel cleaning techniques for endoscopes, where brushes and cleaning fluids work together and are not designed to complement the performance of each technique. These innovations not only address current issues associated with brushes, but also complement and improve the effectiveness of cleaning fluids used in the channels of the endoscope. In addition, certain embodiments provide the advantage of being able to clean the lumens of an endoscopic instrument without creating defects in the surface of the internal lumen. This extends the life of the instrument and allows the instrument to be cleaned multiple times without providing yet another area for biological material, pathogens, or other debris to settle. In certain embodiments, these innovations provide a device that can rapidly and consistently dry the internal lumens or channels of an endoscopic instrument.

In one embodiment, a desiccant device for use with an endoscopic instrument includes an elongate member configured for advancement through a lumen within the endoscopic instrument and a desiccant element coupled to at least a portion of the elongate member. The desiccant element includes a portion having an outer diameter equal to or greater than the outer diameter of the elongate member.

In embodiments, the elongate member includes an attachable push and pull element, such as a navigation element, that can be advanced from a proximal end of an internal lumen of an endoscopic instrument, such as a biopsy channel on an endoscope, to a distal end of the biopsy channel to exit the biopsy channel and connect to the desiccation element. In certain embodiments, the desiccation element can be removably attached to a distal end portion of the advancement element or navigation element. In other embodiments, the desiccation element is permanently attached to the navigation element. These embodiments allow the desiccation element to be translated from the distal end of the endoscope lumen to the proximal end or vice versa.

In one embodiment, the desiccant member includes distal and proximal end portions having a diameter substantially equal to or greater than the inner diameter of the lumen, and a variable pressure central portion between the distal and proximal end portions. Alternatively, the proximal and distal end portions can have a diameter substantially less than the inner diameter of the lumen. The variable pressure central portion is shaped to create a pressure gradient down the central portion from the distal end portion to the proximal end portion. This pressure gradient provides an increase in relative velocity between the desiccant member and any air or fluid within the lumen as the desiccant member is advanced through the lumen. The high air-fluid velocity increases the shear stress between the air or fluid and the lumen wall, thereby creating a stronger force to desiccate the wall.

In certain embodiments, the drying device is sterilized or disinfected, such that the disinfected and/or sterilized device channel is not compromised by the drying process. Conversely, when the drying device is passed through an already disinfected or sterilized device channel, water and moisture are removed without altering or contaminating the disinfected or sterilized device channel.

In embodiments, the proximal and distal end portions of the desiccant member create a consistent circumferential contact with the inner wall of an endoscope channel, such as a biopsy channel or aspiration 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 exemplary embodiments, the diameter of the proximal and distal end portions is about 1 to about 1.5 times the diameter of the inner lumen, preferably about 1.25 times this diameter. This avoids flexing of the proximal and distal end portions, thereby reducing buckling and the creation of gaps between the desiccant element and the inner wall of the lumen.

The variable pressure central portion is designed to generate a variable pressure between the two circumferential contact elements and the wall of the channel to be cleaned. Thus, when the drying member is advanced through the channel, the scope, and inside the channel, i.e., when moving the drying element through the lumen, the variable pressure design between the two circumferential elements generates either a vortex, a Venturi effect, a reverse Venturi effect or an anti-Venturi effect, or other variable pressure between the drying element and the wall of the endoscope channel.

In certain embodiments, the central portion of the desiccant member includes a constriction section coupled to the proximal end portion, a diffusion section coupled to the distal end portion, and a throat section coupling the diffusion section and the constriction section. The throat section has a diameter smaller than the diameters of the proximal and distal end portions and larger than the diameters of the diffusion and constriction sections.

The variable pressure region between the two cylindrical elements may include an inverted partial venturi shape, a parabolic shape, a variable inclined shape, or other shapes that create a variable pressure or vortex between the two cylinders and the wall of the channel being dried, thereby increasing the force against the channel wall as the drying member advances. In an exemplary embodiment, the throat section is substantially cylindrical. The contraction section preferably increases in diameter from the proximal end portion to the throat section, and the divergence section preferably decreases in diameter from the throat section to the distal end portion, thereby creating a vortex, Venturi effect, reverse Venturi effect or anti-Venturi effect, or other variable pressure between the distal and proximal end portions of the drying element.

The angle of inclination of the converging section may vary depending on the diameter of the channel being dried and other factors, and should be sufficient to facilitate variable pressure flow between the cylindrical bodies as the drying element advances. In certain embodiments, the converging section defines an angle of between about 4 degrees and about 85 degrees, preferably between about 15 degrees and about 30 degrees, with the proximal end portion. Similarly, the diverging section defines an angle of between about 4 degrees and about 85 degrees, preferably between about 15 degrees and about 30 degrees, with the distal end portion. In other embodiments, the converging section can have more than one inclined, curved, variable, or other shape to assist in varying the pressure between the two cylindrical elements.

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

The length and diameter of each section of the variable pressure region is preferably selected to optimize vortex, Venturi effect, reverse Venturi effect or anti-Venturi effect, or other variable pressure, and will vary based on the diameter of the internal lumen and other factors. For example, for a lumen having a diameter of about 4.2 mm, the length of the throat section can be about 2 mm to 10 mm, preferably about 3 mm to 5 mm, and more preferably about 4 mm. The diameter of the throat section will also depend on the diameter of the internal lumen and the diameters of the contraction and divergence sections. In certain embodiments, the throat section has a diameter smaller than the diameter of the internal lumen but greater than 50% of the lumen diameter, preferably greater than about 60% of the lumen diameter, and more preferably equal to or greater than about 70% of the lumen diameter.

When advancing the desiccant element through the lumen, the variable pressure region of the desiccant 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 in at least one region between the distal end portion and the proximal end portion of the desiccant element. This peak pressure is preferably at least 100 Pa, and 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.

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

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

In certain embodiments, the desiccant device/element includes more than one desiccant member. For example, in one such embodiment, the desiccant device includes 2-10 desiccant members, preferably 2-5 desiccant members. To enhance the effectiveness of the device, the desiccant members can be joined together to provide a series of such desiccant members down the navigation element or separated by various distances. In these embodiments, for example, the proximal end portion of one desiccant member can be joined to or integrated with the distal end portion of the next desiccant member along the series. Each of the desiccant members includes distal and proximal end portions having a diameter substantially equal to or greater than the inner diameter of the lumen, and a central portion between the distal and proximal end portions. The central portion of each desiccant member is shaped to generate a pressure gradient down the central portion from the distal end portion to the proximal end portion. These variable pressure elements within each desiccant member can be the same or different to generate alternating pressure profiles. The multiple cylindrical elements sandwiching the variable pressure elements therebetween can be a set of more or less than five as appropriate for a given application.

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

In embodiments, the desiccant or elongated navigation member may include an element that centers the navigation element and desiccant device as the device is pulled or pushed through the lumen, around kinks, and through corners and other complex areas including junctions of multiple lumens and internal channels to be cleaned within an endoscope or other instrument. In embodiments, this centering element is smaller than the diameter of the lumen through which the device is advanced, but has a size significant enough to prevent misalignment and deflection of the navigation element to one side or another of the lumen as it passes, including when the cleaning device is pulled or pushed around bends, corners, and junctions (including Y-junctions) of various lumens.

In some embodiments, the centering element can include a series of shaping elements protruding from the elongate member or navigation member. The series of shaping elements can include, for example, posts, spikes, or other protrusions extending radially outward from the elongate member and sized to substantially center the elongate member and/or the drying/cleaning element within the internal channel of the endoscopic device.

The centering element can be any shape that keeps the device approximately centered within the lumen and prevents the deflection described above, with the preferred embodiment being a cylinder with a reduced diameter distal end. When this type of misalignment occurs, which is a problem with existing brushes and pull-through devices as the device is pulled around curves, corners, and junctions in the lumen, the brushes and other elements are pulled to one side of the lumen, resulting in minimal, detrimentally modified, or lost contact between the lumen wall and the desiccant element (whether a brush, pull-through device, or other device), with adverse effects on the effectiveness of the desiccant technique. Placing the centering element at the front or rear of the device, or both, corrects this problem and provides more consistent and effective desiccation, especially around curves, corners, channel junctions, and other complex areas inside an endoscope, other endoscopic instrument, or endoscopic device.

In preferred embodiments, the centering element has a diameter or height between 50 and 90 percent of the diameter of the lumen to be cleaned, and in more preferred embodiments, between 70 and 85 percent of the diameter of the lumen to be cleaned. The centering element can be any shape that maintains centering of the desiccant element as it navigates through the channel. In embodiments, the shapes include cylindrical, conical, and spherical, and the centering element can be located in the distal section of the device, at the distal and proximal ends, between the desiccant members, or at the proximal end, particularly as appropriate to help center the desiccant element as it navigates around bends in the lumen, across Y-junctions, and other aspects.

In certain embodiments, the desiccant device includes a programmable motor coupled to the elongated member and configured to translate the device through the lumen of the endoscopic instrument. Preferably, the programmable motor is configured to withdraw the elongated member through the lumen a specified distance for a specified duration. For example, the motor can be programmed to withdraw the elongated member at a particular speed that optimizes the high speed that the variable pressure region generates within the desiccant member, thereby ensuring that the internal lumen is adequately dried without damaging the surface.

In another aspect, a kit for cleaning and drying an endoscopic instrument includes a drying device having an advancing element configured to advance through a lumen in the endoscopic instrument and at least one drying member coupled to a portion of the advancing element. At least a portion of the drying member is shaped and configured to substantially maintain contact with a wall of the lumen upon advancement of the advancing element through the lumen. The kit further includes a cleaning device having an elongate member configured to advance through a lumen in the endoscopic instrument and at least one cleaning member coupled to a portion of a 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 shaped to generate a pressure gradient down the central portion from the distal end portion to the proximal end portion.

In one embodiment, the drying device is one of the embodiments described above 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 down the central portion from the distal end portion to the proximal end portion.

The cleaning device may 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 the two circumferential elements and the walls of the channel to be cleaned. Thus, when the cleaning member is advanced inside the channel, i.e., moving the cleaning element through the lumen, and the scope and the channel of the scope are submerged in the cleaning fluid (as required by the scope manufacturer), the variable pressure design between the two circumferential elements generates either a vortex, a Venturi effect, a reverse Venturi effect or an anti-Venturi effect, or 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 influences the fluid flow so that the fluid moves from a high pressure zone, across a low pressure zone, and then back pressure-wise to another high pressure zone between the two cylindrical elements. This induces the cleaning fluid at the location of the channel wall with high velocity and force, thereby removing more biological material and other debris than with conventional devices. This same approach applies in embodiments using a drying device, where air is induced by the creation of either a vortex, Venturi effect, reverse Venturi or anti-Venturi effect, or other variable pressure between the drying element and the walls of the channel as the device moves through the channel to remove fluid and moisture and dry the channel.

In certain embodiments, the drying device of the kit includes an advancement element, which may be a filament, wire, tube, or other element capable of advancement into the interior channel, including long, curved, or other channels that are invaginated or difficult to access due to their interior location. In embodiments, the element may be gripped at an end after being pulled through the interior channel and then pulled through the channel as part of the drying process. Similarly, the advancement element may be advanced by pushing the element from the other end. The element may include versions that can advance air through the device into the channel, including locations that are removed well inside the channel and beyond the typical effects of forced air drying within the channel.

The drying member may include one or more substantially cylindrical members spaced apart from one another along the advancing member. The cylindrical members are configured to maintain contact with the channel walls to displace and remove any moisture as the advancing element advances through the channel. The advancing element may be advanced by being pushed in and pulled out, or by other means including rocking back and forth, advancing and withdrawing based on a pattern. The advancing element may be advanced through the endoscope by connection to an automated or mechanized technique or any other means for moving the channel drying element through the channel to displace, absorb, and/or remove water by direct contact with the surface area to be at least partially dried.

The desiccant member may be a disk, fin, squeegee, or other protrusion extending outwardly from the elongate member. In embodiments, the desiccant member is shaped to create a consistent circumferential contact with the inner walls of an endoscope channel, such as a biopsy channel or aspiration channel, when the elongate member is advanced through these channels.

In certain embodiments, the desiccant member preferably has a substantially annular, circumferential, cylindrical, or conical shape with at least one portion of the element having a diameter approximately equal to or slightly larger than the diameter of the inner lumen. In an exemplary embodiment, the diameter of the proximal and distal end portions is about 1 to about 1.5 times the diameter of the inner lumen, preferably about 1.25 times this diameter. This avoids flexing of the proximal and distal end portions and thereby reduces buckling and the creation of gaps between the desiccant element and the inner wall of the lumen.

In certain embodiments, the elongate member of the drying device includes a filament, wire, tube, shaft, or other element capable of advancing into an interior channel, including long, curved, or other channels that are difficult to access due to being invaginated or internal. In embodiments, the element can be gripped at an end after being pulled through the interior channel and then 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. The element can include versions that can advance air through the device into channels, including locations that are removed well inside the channel and beyond the typical effects of forced air drying within the channel.

The drying member may include one or more substantially annular or cylindrical members spaced apart from one another down the elongated member. The cylindrical members are configured to maintain contact with the channel walls to displace and remove any moisture as the elongated elements advance through the channel. The elongated elements may be advanced by being pushed and pulled, or by other means including rocking back and forth, advancing and withdrawing based on a pattern. The elongated elements may be advanced through the endoscope by connection to an automated or mechanized technique or any other means for moving the channel drying element through the channel to displace, absorb, and/or remove water by direct contact with the surface area to be at least partially dried.

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

In an embodiment, the drying member may include a series of one or more cylindrical squeegees designed to make wall contact with the inner walls of the channel to remove fluids and moisture from the channel. These cylindrical squeegees may be arranged in any manner effective to remove fluids and moisture from the channel, including arrangements of groups of two followed by groups of three or in reverse order, or other squeegee configurations, such as a group of one squeegee followed by a group of two, a group of two followed by a group of four, a group of three followed by a group of four, four in a row, five in a row, or any other number and configuration of squeegees effective to remove water and moisture and dependent on the diameter, length, curvature of the channel, junctions with other channels, and other factors.

In embodiments, certain of these squeegees can be of different heights to make the device more adaptable for use with different sized channels. For example, the device can have a squeegee with a diameter of 5 mm to 5.2 mm, followed by a smaller squeegee with a diameter between 2 mm and 2.2 mm, followed by another squeegee with a diameter of 3.8 mm to 4 mm to create variable wall contact across different channel sizes. In embodiments, the squeegee height and placement are not limited to this description, and these diameters, placements, squeegee thicknesses, and more will vary based on what is most effective for drying for a given channel drying application.

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 1 mm, 1.25 mm, 1.5 mm, 2 mm spacing, narrow 1.25 mm spacing followed by a 4 mm gap, followed by 1.25 mm to 1.5 mm spacing, or narrower, wider, or other more variable spacing that optimizes and promotes rapid and predictable channel drying. The spacing, diameter, alignment, and grouping of the drying elements, in embodiments, can vary based on the channel size, channel material, number of bends as it navigates from one to the other, number of junctions with other channels, channel dryer material if any, and other factors unique to a given channel drying application.

The thickness of the squeegee and fins is any thickness that aids in drying the channel and aids in positioning the fins and squeegees to be dried and, in embodiments, cleaned. In embodiments, this thickness includes squeegee and fin thicknesses between 0.2 mm and 0.5 mm, other variations having thicknesses from 0.5 mm to 1.0 mm, and other different values having a reduced thickness that is thicker at the base of the squeegee or fin and tapers as it approaches the channel wall to improve the flex and conformity of the element to the channel wall while providing support around the advancing element and providing a predetermined stiffness and flexibility.

The annular members are spaced apart from one another down the elongate member. 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 and second annular members are spaced apart from one another by a distance that is greater than the distance that the second and third annular members are spaced apart from one another.

In one embodiment, the system includes at least first and second annular member groups, each having a plurality of annular members. The annular members within each group can be substantially equally spaced from one another or can be differently spaced. The first group is spaced from the second group by a distance that is greater than the spacing within each of the first and second groups.

In another embodiment, the elongate member includes a rod member having a first end and a second end, and a loop coupled to the first end. The device may further include a swab member having a first end attached to the loop and a second end including a tail. The swab member may have first and second ends, where the first end is attached to the loop and the second end includes a tail like a kite tail, where the tail may be of any length. The swab member may include one or more materials that may be braided or twisted, and the tail end of the swab member includes an end that is not braided or twisted and is comprised of one or more materials that make up the swab member. Additionally, the swab member may include a foam material and/or a microfiber material.

Furthermore, the rod member may comprise one continuous polymer rod whose looped end comprises one thickness or diameter and whose straight end comprises two thicknesses or diameters of the looped end of the rod. The two thicknesses or diameters of the polymer rod forming the straight end of the rod member may be melted or bonded together, laminated together, or co-extruded.

In an embodiment, the drying device includes a centering element to keep the drying element centered as it advances through the channel being dried. This centering element prevents the drying element from losing contact with the walls of the channel being dried, enhancing the drying action. The centering element can be any shape that keeps the device approximately centered within the lumen and prevents the deflection described above, with a preferred embodiment being a cylindrical shape with a reduced diameter distal end. When this type of misalignment is created as the device is pulled around bends, corners, and junctions in the lumen, which is a problem with existing brush and pull-through devices, the brush and other elements are pulled to one side of the lumen, resulting in minimal, detrimentally modified, or lost contact between the lumen wall and the drying element (whether a brush, pull-through device, or other device), with a detrimental effect on the effectiveness of the drying technique. Placing a centering element at the front or rear of the device, or both, corrects this problem and provides more consistent and effective drying, especially around bends, corners, channel junctions, and other complex areas inside an endoscope, other endoscopic instrument, or endoscopic device.

In preferred embodiments, the centering element is between 50 and 90 percent of the diameter of the lumen to be cleaned, and more preferred embodiments have a diameter or height between 70 and 85 percent of the diameter of the lumen to be cleaned.

In some embodiments, the centering element can include a series of shaping elements protruding from the elongate member or navigation member. The series of shaping elements can include, for example, posts, spikes, or other protrusions extending radially outward from the elongate member and sized to substantially center the elongate member and/or the drying/cleaning element within the internal channel of the endoscopic device.

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 shaped to generate a pressure gradient down the central portion from the distal end portion to the proximal end portion.

In this aspect, the drying/cleaning device is configured to clean and dry the inner lumen as it is passed through it. In embodiments, this version may be particularly advantageous for cleaning and drying after the use of liquid chemical sterilants and disinfectants.

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

In one embodiment, the drying element is injection molded, 3d printed, or otherwise formed, or otherwise attached, either by overlaying, connecting, or gluing to the advancement element. The drying element can be 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 made of 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 a combination of hard and soft materials with various elasticities.

In embodiments, variations of the dryer portion of the present invention can include materials capable of absorbing water, such as sponges, absorbent cloth materials, or other materials capable of absorbing and retaining 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 as the advancing element is passed through the channel. These absorbent materials can be placed at the end or beginning of the dryer element or interspersed between other dryer elements such as squeegees or fins.

In embodiments, the drying elements of the present invention can be of any shape or form, including a squeegee, a cylinder, a series of absorbent strips, venturi or inverted venturi shapes, oblong and round shapes, ball or spherical drying elements that can move water and moisture by their advancement or withdrawal.

The invention can include coatings to aid in hydrophilicity or hydrophobicity and to aid navigation by varying friction levels. The invention can have lumens that allow air to blow through the invention to deliver forced air deep inside the channel close to or adjacent to the channel walls.

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

In an embodiment, the central portion of the desiccant member includes a constriction section coupled to the proximal end portion, a diffusion section coupled to the distal end portion, and a throat section coupling the diffusion section and the constriction section, the throat section having a diameter smaller than the diameters of the proximal and distal end portions and larger than the diameters of the diffusion and constriction sections.

In an embodiment, the method further includes centering the desiccant member within the lumen as it is advanced through the lumen. Preferably, the centering element is smaller than the diameter of the lumen through which the device is advanced, but of a size significant enough to prevent misalignment and deflection of the navigation element to one side or another of the lumen as it passes, including when the desiccant device is pulled or pushed around various lumen bends, corners, and junctions (including Y-junctions).

The method includes introducing a guide element through a first opening in a lumen of the instrument and advancing an elongated dry device through a second opening in the lumen such that at least a portion of the elongated dry device engages the guide element. The guide element engages and couples to the dry device such that the dry device can be withdrawn relative to the first opening of the lumen.

In certain embodiments, the endoscope lumen includes a first lumen and a second lumen joined together at a junction, such as a Y-junction between a biopsy channel and an aspiration channel in the endoscope. In these embodiments, the method further includes introducing a guide element through the first lumen until it passes the junction and into the second lumen, and advancing the elongated drying device through the second lumen such that it engages the guide element. The guide element can then be used to pull the drying device past the junction and through the first lumen. This ensures that the drying device dries the biopsy channel without flexing and continuing proximally past the Y-junction and deep into the aspiration channel.

In other embodiments, the endoscope lumen includes a twist or bend having a relatively small radius of curvature through which it would otherwise be difficult to advance a desiccant element. In these embodiments, a guide element is introduced and advanced through the lumen on one side of the twist. A desiccant 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 withdraw the desiccant device through the twist.

The guide element can include a tubular sheath or similar device having a distal end portion configured to engage an 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 an outer diameter of the proximal end portion of the elongated dry element and can be further configured to distort or otherwise guide the dry element past a junction or other convoluted area within the lumen.

In certain embodiments, the tip of the guide element is tapered to better match the shape of the multi-channel internal junction in the scope. In embodiments, the proximal end of the guide element can have a flange that is larger than the entrance opening to the particular scope channel into which the navigation element is inserted, to prevent the navigation element from being fully advanced into the channel, thereby making withdrawal difficult. In alternative embodiments, the navigation element may not have a flange, but may have a marker, including, for example, a pad printed or other line that bounds the maximum recommended point of advancement of the navigation element into the scope channel or other channel.

In other embodiments, the cleaning/drying device may have one or more absorbent sponges disposed at the front or end of the cleaning/drying device or between one or more of the cylindrical elements to absorb biological material and debris. The absorbent sponge may have a single cell configuration or multiple sponges with different cell configurations in providing wiping, absorbing, lifting, spreading, or a combination of cleaning fluid attributes. The absorbent sponge may include any material that absorbs biological material, fluids, 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, dried 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 ability to expand 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 that the sponge occupies.

In embodiments, the sponge is soft and atraumatic when submerged in fluid, expands to a size at least sufficient to remove debris from the channel being cleaned (and/or remove moisture and fluid from the channel), and in preferred embodiments is larger than the channel being cleaned. The sponge can be any shape and size that fits into and assists in cleaning the channel of the scope, including, but not limited to, cylindrical, spiral, conical, triangular, square, or any combination thereof.

For example, a cleaning or drying member may have more than one cylindrical element disposed in close proximity to another element, including one or more elements of cylindrical or other shape, with spacing between the elements that does not create variable pressure on average, followed by or alternatively preceding a cylindrical element having a spacing between the next cylindrical element that creates variable pressure between the cleaning/drying member and the wall of the channel being cleaned. In an embodiment, a series of cylindrical elements may be organized with various spacings that create variable pressure between the cylindrical elements and predetermined spacings that create constant pressure between the cylindrical elements.

In other embodiments, the devices disclosed herein can be used to dry and/or clean the indwelling device. In these embodiments, the device can further include a sheath or similar structure covering the cleaning and/or drying elements and/or navigation elements to avoid disturbing the biological material and any biofilm accumulated therein during translation 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 and/or drying elements can expand when the sheath is withdrawn. Alternatively, electrically responsive polymers can be used to change shape and expand by the application of energy, causing these polymers to expand and contact or at least partially contact the walls of the catheter.

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

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not limiting of the present description. Additional features of the present description will be set forth in part in or can be learned by the practice of the following description.

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

FIG. 1 illustrates an exemplary endoscope for use with the disinfection systems and methods disclosed herein. 1 is a cross-sectional view of a representative endoscope showing one or more lumens within the endoscope. 1A-1C illustrate damage that may occur to a typical endoscope during use and/or cleaning with conventional devices. FIG. 2 is a side view of an exemplary embodiment of a cleaning and/or drying element. FIG. 5 illustrates a fluid pressure distribution generated by the cleaning and/or drying element of FIG. 4 . 5 illustrates a direct pressure generated against and along an internal lumen by the cleaning and/or drying element of FIG. 4. 5 illustrates a shear stress pressure generated against and along an interior lumen by the cleaning and/or drying element of FIG. 4. FIG. 2 is a side view of a cleaning and/or drying device including a plurality of cleaning and/or drying elements coupled to one another; FIG. 2 is a side view of another embodiment of a cleaning and/or drying device having a plurality of cleaning and/or drying elements. FIG. 2 is a perspective view of another embodiment of the cleaning and/or drying device; FIG. 1 is a top view of a system for cleaning and/or drying a lumen in an endoscopic device. FIG. 2 is a side view of the cleaning and/or drying element and the navigation element. FIG. 13 is a side view of an alternative embodiment of the cleaning and/or drying device. 13A-13C show yet another alternative embodiment of the cleaning and/or drying device. 13A-13C show yet another alternative embodiment of the cleaning and/or drying device. 13A-13C show yet another alternative embodiment of the cleaning and/or drying device. 13A-13C show yet another alternative embodiment of the cleaning and/or drying device. 1 is a side view of another embodiment of a cleaning and/or drying device incorporating a cleaning and/or drying element and a navigation element. FIG. 1 is a side view of a cleaning and/or drying element and a navigation device illustrating how the devices can be removably coupled to one another. 13A-13C illustrate another method for removably coupling a cleaning and/or drying device to a navigation device. 13A-13C illustrate yet another method for removably coupling a cleaning and/or drying device to a navigation device. FIG. 1 illustrates test data from a comparison of pressure generated by cleaning and/or drying elements disclosed herein and prior art devices. FIG. 17 illustrates the peak pressure cleaning and/or drying area produced by the device of FIG. 16. FIG. 17 illustrates a positive pressure cleaning and/or drying area produced by the device of FIG. 16. FIG. 13 is a perspective view of an embodiment of a cleaning and/or drying device according to an alternative embodiment. 20 illustrates the use of the cleaning and/or drying device of FIG. 19 within a representative lumen of an endoscopic instrument. 20 shows an alternative embodiment of the cleaning and/or drying device of FIG. 19. 20 shows an alternative embodiment of the cleaning and/or drying device of FIG. 19. FIG. 2 is a perspective view of another embodiment of the cleaning and/or drying device; FIG. 23 is a cross-sectional view of a distal end portion of the cleaning and/or drying device of FIG. 22. FIG. 13 shows another embodiment of the cleaning and/or drying device. FIG. 1 illustrates a guide element for use with the cleaning and/or drying device disclosed herein. 13A-13C show another guide element for use with the cleaning and/or drying device disclosed herein.

This description and the accompanying drawings illustrate several exemplary embodiments and should not be construed as limiting, and 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 cases, well-known structures and techniques are not shown and described in detail so as not to obscure this description. Similar numbers in two or more figures represent the same or similar elements. Furthermore, elements and related aspects described in detail with reference to one embodiment can be included in other embodiments where they are not specifically shown or described, as long as they are feasible. For example, an element can be described in detail with respect to one embodiment and not described with respect to a second embodiment, and yet the element can be claimed to be included in the second embodiment. Furthermore, the depictions herein are for illustrative purposes only and do not necessarily reflect the actual shape, size, or dimensions of the system or illustrated components.

Please note that when used in this specification and the appended claims, the singular forms "a," "an," and "the" and the use of any singular form of any word include plural referents unless it is expressly and unambiguously limited to one referent. The term "comprises" and its grammatical variations as used herein are intended to be open-ended so that the recitation of listed items does not exclude other similar items that may replace or be added to those listed items.

Although the following description is primarily directed to endoscopes and devices for cleaning and/or drying same, it should be understood that the features of the disinfection system of this description can be readily adapted for use with a variety of endoscopic instruments and devices, reusable or disposable, including internal lumens and other interior spaces, such as endoscopes, trocars, cannulas, dilation devices, Foley catheters, guidewires, central venous catheters, bipolar or monopolar electrosurgical or ultrasound devices, pulmonary ventilation devices, ventilators, CPAP and other positive pressure airway devices, robotic and remote surgical equipment, arterial lines, drainage catheters, peripherally inserted central catheters, endotracheal tubes, feeding tubes, and other devices that are deployed, penetrated, and/or navigated within the body.

As used herein, the term "endoscope" refers to any endoscope for or used in medical applications involving the body (human or otherwise), including, for example, laparoscopes, arthroscopes, colonoscopes, gastroscopes, duodenoscopes, ultrasound endoscopes, bronchoscopes, enteroscopes, cystoscopes, laparoscopes, laryngoscopes, sigmoidoscopes, thoracoscopes, cardioscopes, and endoscope-based saphenous vein harvesters, whether robotic, non-robotic, or non-medical.

A variety of scopes are used when remote visualization of the inside of a patient's body is performed. The scope used depends on the extent to which the physician needs to navigate inside the body, the type of surgical instruments used for the procedure, and the level of invasiveness appropriate for the type of procedure. For example, visualization of the inside of the gastrointestinal tract may involve the use of endoscopes in the form of flexible gastroscopes and colonoscopes, as well as specialized duodenoscopes with lengths that may span many feet and diameters that may be greater than one centimeter. These scopes can be pivoted and articulated or steered by the physician as the scope is navigated through the patient. Many of these scopes include one or more working channels for passing and supporting instruments, fluid and irrigation channels for irrigating tissue and cleaning the scope, gas injection channels for injecting gases to improve navigation and visualization, and one or more light guides for illuminating the field of view of the scope.

Smaller, less flexible or rigid scopes, or a combination of flexible and rigid, are also used in medical applications. For example, smaller, thinner, and much shorter scopes are used when examining joints and performing arthroscopic surgery, such as shoulder or knee surgery. When a surgeon uses arthroscopic surgery to repair a torn meniscus in the knee, a shorter, more rigid scope is typically inserted through a small incision on one side of the knee to visualize the injury while instruments are passed through an incision on the opposite side of the knee. These instruments can maintain visualization and irrigate the scope inside the knee to manipulate tissue and complete the repair.

Other scopes may be used in diagnoses and procedures using minimally invasive endoscopic procedures, including, but not limited to, the use of scopes for examining and treating pathologies in the lungs (bronchoscopes), the mouth (enteroscopes), the urethra (cystoscopes), the abdomen and peritoneal cavity (laparoscopes), the nose and sinuses (laryngoscopy), the anus (sigmoidoscopes), and other aspects of the gastrointestinal tract (gastroscopes, duodenoscopes, colonoscopes), and the chest and thoracic cavity (thoracoscopes). Additionally, robotic medical devices also rely on scopes to provide remote visualization of the area they are evaluating and performing procedures on.

These and other scopes can be inserted through natural orifices (such as the mouth, sinuses, ears, urethra, anus, and vagina), as well as through incisions and port-based openings in the patient's skin, cavities, skull, joints, or other medically designated entry points. Diagnostic uses of endoscopy with visualization using these medical scopes include probing symptoms of disease such as gastrointestinal disorders (e.g., nausea, vomiting, abdominal pain, gastrointestinal bleeding), supporting diagnoses (e.g., by performing biopsies for anemia, bleeding, inflammation, and cancer), or surgical procedures for disease (e.g., removal of a ruptured appendix or cauterization of intragastric bleeding).

1, a representative endoscope 10 includes a proximal handle 12 coupled to an elongated shaft 14 adapted for endoscopic or percutaneous insertion into a body cavity of a patient and adapted for manipulation by a surgeon or clinician. 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 can include several different tubes coupled to an internal lumen within the shaft 14 for delivery of fluids such as water and air, suction, and other features that a clinician may desire to move fluids, blood, debris, and particulate matter out of the field of view. This clearance provides a clearer view of underlying tissue or material for evaluation and treatment. In this representative embodiment, the fluid delivery system 16 includes a water jet connector 18, a water bottle connector 20, a suction connector 22, and an air pipe 24. The water jet connector 18 is coupled to an internal water jet lumen 28 that extends through the handle 12 and the elongated shaft 14 to the distal end of the endoscope 10. Similarly, the water bottle connector 20, the suction connector 22, and the air pipe 24 are each connected to an internal lumen 30, 32, 34, respectively, that passes through the shaft 14 to the distal end of the endoscope 10.

The proximal handle 12 may include various controls for a surgeon or clinician to operate the fluid delivery system 16. In this exemplary embodiment, the handle 12 includes a suction valve 34, an air/water valve 36, and a biopsy valve 38 for extracting tissue samples from a patient. The suction channel 34 forms a relatively sharp twist or bend 22A emanating from the suction connector 22 and extends through the universal cord 15 into the handle 12. The suction channel 34 then extends through the shaft 14 to the distal end of the endoscope 10. Where the suction channel 34 passes through the biopsy valve 38, it forms an internal Y-junction 38B with a channel 38C that extends into the biopsy valve 38. This Y-junction 38b presents a challenge when cleaning and/or drying the suction channel 34 using conventional devices, as discussed in more detail below.

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 light delivery system. Similarly, the term "image capture device" as used herein does not necessarily refer to a device having only a lens or other light guiding structure. To the contrary, for example, it is contemplated that the image capture device can be any device capable of capturing and transmitting an image, including (i) a relay lens between an objective lens at the distal end of the scope and the eyepiece, (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 simply a chip for sensing light and generating an electrical signal for communication corresponding to the sensed light, or other technology for transmitting an image. The image capture device can have a viewing end where light is captured. In general, the image capture device can be any device capable of viewing an object, capturing an image, and/or capturing an image.

In some embodiments, the endoscope 10 includes some form of positioning assembly (e.g., a hand control) that is attached to the proximal end of the shaft and allows the operator to steer the scope. In other embodiments, the scope is part of a robotic element that allows for steerability and positioning of the scope to a desired point to probe and focus the scope.

As shown in FIG. 2, the endoscope 10 may further include a camera lens 62, a scope washer 32, and a light source 60 for providing a view of the surgical site within the patient's body, and a biopsy channel 50 for passing instruments therethrough. The biopsy channel 50 allows for the passage of instruments along the shaft 14 of the endoscope 10 for removing tissue. The biopsy channel 50 may act as a working channel for passing other instruments through the endoscope 10 for evaluation and procedure of tissue and other materials. Such instruments may include cannulas, catheters, stents and stent delivery systems, papillotomes, wires, other imaging devices including miniscopes, baskets, snares, and other devices for use with the scope within the lumen. Alternatively, the endoscope 10 may include separate working channels for these instruments.

Figure 3 shows an interior lumen 70 of a representative endoscope, e.g., a biopsy channel, a working instrument channel, or a water/air channel. As shown, the interior surface of the lumen 70 has been either damaged during a previous procedure or damaged by a conventional cleaning device. Thus, the lumen 70 contains many imperfections 72 that provide extremely small areas for pathogens, biological material, tissue, or other debris to hide within. These imperfections 72 are very difficult to clean and dry using conventional devices. Furthermore, because these imperfections hide biological material, the biological material protects the pathogens therein from conventional sterilization and disinfection techniques.

An exemplary cleaning and/or drying device will now be described. 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 may be removably attached or permanently secured to the shaft. The shaft may include any suitable material that provides sufficient rigidity to allow it to be advanced 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 ranging from about 0.5 mm to about 5 mm, preferably about 1 mm to 4 mm.

In certain embodiments, the device includes a retraction cable configured to retract or advance the elongate shaft within the internal lumen within the endoscope 10. Additionally, the device may include an energy source and a motor for advancing and/or retracting the elongate shaft. Of course, it will be appreciated that the elongate shaft may be manually translated through the internal lumen by a proximal handle or suitable actuator (i.e., not a motor).

A portion of the cleaning and/or drying device 200 according to certain embodiments will now be described with reference to FIG. 4. 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 from the biopsy channel of the scope to the distal end of the biopsy channel to exit the same and connect to the cleaning and/or drying element. The navigation element 301 can be advanced from the proximal end of the biopsy channel of the scope to the distal end of the biopsy channel (or suction channel when applicable) to exit the biopsy channel to connect to the cleaning and/or drying element, or alternatively advanced through the channel from the proximal end of the biopsy channel (or suction channel) to the distal end and withdrawn. The push and/or pull navigation element may be attached to the cleaning and/or drying element 300, and in some embodiments may be detachable, while in other embodiments may be permanently attached.

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 threaded through the internal lumen of the endoscopic device. For example, the navigation element 301 can be advanced down the biopsy channel 38C from a proximal entrance to the biopsy channel 38C, exiting the distal end of the biopsy channel and connected to the cleaning and/or drying element 300, whereby the entire system can then be withdrawn from the distal end of the scope to the biopsy channel and exiting the proximal end of the biopsy channel. This approach allows for successful cleaning of the biopsy channel without having the problems with current technology of allowing debris and biological material to accumulate and push it out the distal end of the biopsy channel, resulting in extra contamination of the parts of the scope that are most difficult to clean. Additionally, this approach also allows for successful drying of the biopsy channel.

The unique ability to advance the navigation element, then connect to the cleaning and/or drying element at the distal end of the scope, and then withdraw from the distal end to the proximal end of the scope allows for successful cleaning and/or drying without increasing contamination levels at the distal end of the scope, which is most difficult to clean, or alternatively enter the flexible tube through a Y-junction in the scope and clean and/or dry from distal to 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 in the scope, including the suction channel and/or air/water channel when applicable.

In other embodiments, the navigation element 301 and the cleaning and/or drying element 300 are attached to one another and advanced or retracted together through one or more lumens. The navigation element 301 and the cleaning and/or drying element 300 may be manufactured as a single integral device or may be manufactured separately and attached to one another prior to use.

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

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 circular, cylindrical, or conical shape with at least one portion thereof having a diameter 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 about 1 to about 1.5 times the diameter of the internal lumen, preferably about 1.23 times this diameter. For example, if the diameter of the internal lumen is about 5 mm, the maximum diameter portion of the elements 302, 304 can be about 4.2 to 5.5 mm, preferably about 5 mm. This additional size allows the elements 302, 304 to deform slightly as they pass through the lumen, ensuring that they will remain in contact with the lumen.

In certain embodiments, the contact elements are substantially conical so as to slope downward in the proximal direction (or in the direction of travel of the cleaning and/or drying device through the lumen of the endoscope). This configuration allows the contact elements 302, 304 to generate a contact friction force along the inner wall of the lumen to ensure that at least a portion of the contact elements 302, 304 remain in contact with the lumen as they slide along the wall of the internal lumen of the endoscope without getting stuck or otherwise jammed within the lumen. In an exemplary embodiment, the contact elements 302, 304 are approximately 0.75 mm and taper to approximately 0.5 mm at the tip (or point of contact with the inner wall of the lumen).

The cleaning and/or drying element 300 further includes a variable pressure area 306 between the wall contact elements 302 and 304. The variable pressure area 306 is designed to generate 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., moving the cleaning and/or drying element through the lumen, and the endoscope and its channel are submerged in a cleaning fluid (which can be saline or any other biocompatible material safe for use with an indwelling catheter as required by the endoscope manufacturer), the variable pressure design between the two circumferential elements generates either a vortex, a Venturi effect, a reverse Venturi effect or an anti-Venturi effect, or 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 area, this area affects the fluid flow such that the fluid moves from a high pressure area across a low pressure area and then back pressure-wise to another high pressure area between the two cylindrical elements. This directs the cleaning fluid at the channel walls with high velocity and force, similar to the Venturi effect created when you place your thumb partially over the end of a garden hose to intensify the force of the water coming out of the hose.

When used to dry a 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 remove substantially all fluid and moisture from within the lumen.

Alternatively, the variable pressure region 306 can be designed to create low pressure zones at either end and a high pressure zone between them. In this embodiment, as the cleaning fluid or air flows across the variable pressure zone, the zone influences the fluid or air flow such that the fluid or air travels from the low pressure zone across the high pressure zone and then back pressure-wise to another low pressure zone between the two cylindrical elements.

As shown in FIG. 4, the variable pressure region 306 includes a converging section 308 coupled to the proximal contact element 302, a diverging section 312 coupled to the distal contact element 304, and a throat section 310 coupling the diverging section 310 and the converging section 308. The throat section 320 has a diameter smaller than the diameter of the contact elements 302, 204 and larger than the diverging and converging sections 308, 310. This design enhances the performance of the cleaning fluid (or air) by redirecting the fluid (or air, when applicable) from a static interaction point with the wall of the endoscope channel to a dynamic interaction point where the cleaning and/or drying member pressure-directs the fluid or air against the wall of the endoscope channel, enhancing the lifting action of the cleaning fluid's chemical agents (or air, in the case of drying).

The variable pressure region 306 may include an inverted partial venturi shape, a parabolic shape, a variable inclined shape, or other shapes that create a variable pressure between the two cylinders and the channel wall being cleaned, thereby increasing the force with which the cleaning fluid or air is projected onto the channel wall as the cleaning and/or drying member is advanced.

In an exemplary embodiment, the throat section 310 is substantially cylindrical. The converging section 308 preferably expands in diameter from the contact section 302 to the throat section 310, and the diverging section 312 preferably reduces in diameter from the throat section 310 to the contact section 304, thereby creating either a vortex, a Venturi effect, a reverse Venturi effect or an anti-Venturi effect, or other variable pressure between the distal end portion 304 and the proximal end portion 302 of the cleaning and/or drying element 310.

In a preferred embodiment, the variable pressure region 306 has an inverted partial venturi shape with three distinct zones with different spacing from the wall of the endoscope channel, which creates an accelerated hydrodynamic action that projects the cleaning fluid (or air) onto the channel wall for more effective cleaning, or a similar action in the case of air. These zones include the contraction section 308, which is the start zone, where the cleaning fluid (or air) is on the other side of the first cylindrical element. The contraction section 308 is the start zone where the fluid accumulates and undergoes a pressure change as the space available for the fluid changes and becomes smaller as the cleaning and/or drying element 300 advances, and the fluid (or air) is directed into the throat section 310, which further modifies the pressure between the cleaning and/or drying element and the channel wall. The throat section 310, which provides a smaller geometry for the fluid in a manner that changes the pressure on the fluid (or air) compared to the pressure on the fluid (or air) in the contraction section, generates an acceleration of the fluid as the cleaning element 300 advances and/or generates an acceleration of the air as the drying element 300 advances, followed by the diffusion section 312, which promotes the diffusion of the cleaning fluid (or air) at an accelerated rate as the fluid (or air) exits the throat section. These sections between the cylindrical elements together generate a hydrodynamic force sufficient to remove bacteria, biological material, and debris from the walls of the endoscope channel in the case of a cleaning fluid, or a similar force 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.

The angle of inclination of the converging section 308 (defined as the angle made between the vertical section of the conical section 302 and the inclined portion of the converging 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 should be sufficient to facilitate a variable pressure flow of the cleaning fluid or air between the cylindrical bodies as the cleaning and/or drying elements advance. In certain embodiments, the converging section defines an angle of between about 4 degrees and about 85 degrees, preferably about 15 degrees and about 30 degrees, with the proximal end portion (i.e., the contact section 302). Similarly, the diverging section defines an angle of between about 4 degrees and about 85 degrees, preferably about 15 degrees and about 30 degrees, with the distal end portion (i.e., the contact section 304). Of course, it will be appreciated that the various pressure regions 306 can have more than one inclined, curved, variable, or other shape to aid in varying the pressure between the two cylindrical elements 302, 304.

Similarly, the angle between the contraction and divergence sections 308, 312 and the throat section 310 may vary depending on the diameter of the channel being cleaned, the viscosity of the fluid or air, and other factors, and must be sufficient to facilitate variable pressure flow of cleaning fluid or air between the cylinders as the cleaning and/or drying elements advance. In certain embodiments, the angle is from about 10 degrees to about 50 degrees, preferably from about 15 degrees to about 30 degrees, and more preferably from about 20 degrees to about 25 degrees.

The length and diameter of each section of the variable pressure region 306 is preferably selected to optimize either vortex, Venturi effect, reverse Venturi effect or anti-Venturi effect, or other variable pressure, and will vary based on the diameter of the internal lumen, the viscosity of the fluid or air, and other factors. For example, for a lumen having a diameter of about 4.2 mm, the length of the throat section 310 can be about 2 mm to 10 mm, preferably about 3 mm to 5 mm, and more preferably about 4 mm. The outer diameter of the throat section 310 will also depend on the diameter of the internal lumen and the diameters of the contraction and diffusion sections 308, 312. In certain embodiments, the throat section 310 is smaller than the diameter of the internal lumen, but is greater than 50% of the lumen diameter, preferably greater than about 60% of the lumen diameter, and more preferably equal to or greater than about 70% of the lumen diameter (e.g., about 3 mm for a lumen having an inner diameter of about 4.2 mm).

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, and more preferably about 1.75 mm.

The vortex, Venturi effect, reverse Venturi effect or anti-Venturi effect, or other variable pressure created by the variable pressure region 306 affects the fluid flow (and air flow, when applicable) as it moves from a high pressure region across a low pressure region between two cylindrical elements and pressure-wise back to another high pressure region, such that the cleaning fluid or air is directed at the channel walls with a strong force, similar to the Venturi effect created when you place your thumb over the end of a watering hose to increase the force of the water coming out of the hose. This variable pressure design means that when the cleaning and/or drying element 300 is attached to the navigation element and pulled or withdrawn through the endoscope channel, the cleaning fluid or air in the channel and between the cylindrical element and the wall of the endoscope channel moves across the variable pressure region between the two cylindrical spheres, generating a jet of cleaning fluid to pressure wash the channel walls of the endoscope channel with cleaning fluid or air pressure to dry the channel walls.

This unique feature has the powerful effect of enhancing the performance of the cleaning fluid by redirecting the fluid from a static interaction point with the wall of the endoscopic channel to a dynamic interaction point where the cleaning and/or drying element enhances the lifting and stripping action of the cleaning fluid's chemical agents by directing the fluid (or air) by pressure against the wall of the endoscopic channel. In an embodiment, computational modeling using fluid and pressure dynamics has shown that the application of the inverse Venturi principle to generate a variable pressure between two cylindrical elements has produced new and highly effective cleaning and/or drying capabilities that can remove or dry debris, biological material, and bacteria from a channel, including the ability to address changes in the surface relief of the channel by the ability to direct the cleaning fluid (or air) by hydrodynamic forces (or air) into any scratches and crevices in the endoscopic channel by directing the cleaning fluid (or air) by varying and increasing forces of fluid (or air) pressure against all of the channel walls.

This innovation has been shown through computational modeling and testing data evaluating the performance of the cleaning and/or drying elements to divert fluid or air from a static detergent soak to an active pressure washing and cleaning and/or drying regime that affects the direction and force of the cleaning fluid or air and creates a direct beneficial force of the fluid or air against the channel walls. This pressure washing or pressure air drying in the form of a hydrodynamic fluid force or air directed against the channel walls is a measurable force referred to as the fluid or air friction force.

In an embodiment, the variable pressure area 306 described above projects the cleaning fluid or air to the channel walls with a pressure greater than the adhesive force of bacteria or moisture that may cling to the walls, creating a powerful advantage not present in existing brushing technologies. This feature enhances cleaning just as detergents are used with pressure washers to enhance exterior cleaning, such as when a pressure washer is used with detergent to remove dirt from the side of a building or walkway, or enhances drying just as an air dryer is used. This innovation improves the cleaning fluid or drying in a new and powerful way, and also adds other performances into its design that change the channel cleaning performance so that successful endoscopic channel cleaning is not dependent on the performance of a single element, such as the unpredictable wall contact force of a bristle brush or pull-through cleaner, the static performance of the cleaning detergent, or drying based on evaporation over time. The variable pressure area 306 of the cleaning/drying element 300 creates a hydrodynamic/pneumatic pressure that directs the cleaning detergent/air to the walls of the endoscopic channel. A cleaning or drying operation using hydrodynamic pressure forces in combination with mechanical pressure forces to enhance cleaning fluid performance or air drying is the best way to achieve consistent, predictable and reproducible results in removing biological material and debris or drying moisture from the channels of an endoscope or other endoscopic instrument without causing damage to these critical channels.

The combination of cylindrical elements and variable pressure elements is important for generating hydrodynamic/pneumatic forces and adds additional cleaning and/or drying forces by contacting the endoscope channel non-traumatically. These cylindrical elements add force through channel wall contact pressure as an additional cleaning or drying modality to remove or dry debris and biological material from the channel walls and as a complementary cleaning or drying capability in cooperation with the variable pressure elements between the cylinders.

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 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 in at least one region between the distal and proximal end portions of the cleaning element. This peak pressure is preferably at least 100 Pa, and more preferably at least 125 Pa. In an exemplary embodiment, the peak pressure is about 150 Pa. This direct pressure against the lumen wall is sufficient to remove substantially all biological material or moisture from the inner surface of the lumen.

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, and more preferably about 30 Pa over the distance between the proximal and distal end portions of the cleaning element. In an exemplary embodiment, the intermediate pressure is about 36 Pa.

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, and more preferably at least about 8 Pa, in at least one region between the distal and proximal end portions of the cleaning element. The average or mean shear stress over the distance between the proximal and distal end portions of the cleaning element is at least about 1 Pa, preferably greater than about 2 Pa, and more preferably greater than 2.5 Pa. In an exemplary embodiment, the mean shear stress is about 2.8 Pa.

The variable pressure region of the cleaning/drying element is configured to generate a substantially elevated 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 a substantially elevated pressure, thereby increasing the amount of biological material or moisture that can be removed using the device. For definition purposes, applicants have defined the Peak Cleaning Pressure Coverage Area (PPAC®) as the distance between the proximal and distal ends of the cleaning element where the variable pressure region generates a pressure of greater than 50 Pa. In certain embodiments, the cleaning/drying element is configured to generate PPAC over at least about 10% of this distance, preferably at least about 25% of this distance, and more preferably at least about 40% of this distance.

The variable pressure region of the cleaning/drying element is also configured to generate at least some positive pressure against the interior 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 interior 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 with the device. For definition purposes, applicants have defined the positive pressure cleaning area (+PAC®) as the distance between the proximal and distal ends of the cleaning element where the variable pressure region generates a positive pressure (i.e., greater than zero). In certain embodiments, the cleaning/drying element is configured to generate +PAC at least about 25% of this distance, preferably at least about 50% of this distance, and more preferably at least about 75% of this distance. In an exemplary embodiment, +PAC can be as high as 81%.

In an embodiment, a contraction ratio can be determined between the contraction section 308 and the throat section 310, which may vary depending on the diameter of the endoscope channel to be cleaned, the durometer hardness of the material used for the cleaning element 300, the expected speed and force applied to withdraw the navigation element 301 after it is 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 friction force of the cleaning fluid or air projected by the cleaning element 300, and the direction of the flow exiting the throat section, including whether a thin or thick flow is desired for the design.

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

In addition, the angle of the faces of the diffusion section 312 can be in a single plane or multiple planes. In an embodiment, the angle of the faces of the diffusion section 312 increases the space between the wall of the endoscope channel and the cleaning element 300, in an embodiment, the space within the diffusion section. This variation allows the fluid or air to accelerate out of the throat section to a higher pressure and velocity as the cleaning element 300 is advanced through the endoscope channel, creating a force against the wall of the endoscope channel due to the increasing fluid or air pressure.

In embodiments, it is contemplated that the cleaning and/or drying element 300 may not have a three-section arrangement, and may instead have other shapes and configurations intended to modify the pressure between the two cylinders and generate a pressure high enough to remove biological material and debris from the walls of the endoscope channel or to dry the walls of the endoscope channel.

In embodiments, the delivery of the hydrodynamic or air drying force encompasses a significant area of the endoscope channel between the two cylindrical elements such that the application of high force caused by the cleaning element 300 is not narrow, but instead is broader, thereby having a more successful high force to remove or dry biological material and debris. In certain embodiments, the hydrodynamic force is greater than the adhesion force of bacteria or moisture to the channel commonly encountered in medical procedures.

5 and 6 show the overall flow pattern of the fluid or air flowing past the cleaning/drying element 300 within the internal lumen of the endoscopic device. As shown in FIGS. 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 area around the constriction section 308, a higher pressure area around the throat section 310, and an even higher pressure area around the diverging section 312. The hydrodynamic/pneumatic force is 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/pneumatic force is directed at a force 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.

5 and 6A also illustrate that a peak pressure forms around the diffusion section 312. As shown, the peak pressure can reach heights of 100 Pa or greater in this region. In certain embodiments, all pressures in the diffusion section 312 are greater than 50 Pa.

As the cleaning element 300 is advanced 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. Additionally, the diffusing section 312 creates a swirling fluid or air (not shown) within it, thereby increasing the pressure the fluid or air exerts against the inner wall of the lumen.

6B further illustrates the viscous shear stress generated by the cleaning/drying element 300 along the inner wall of the lumen as 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 greater than about 4 Pa, and more preferably greater than 7 Pa. In an exemplary embodiment, the peak shear stress reaches about 8 Pa or greater. The average shear stress across all of the inner wall from element 302 to element 304 is preferably greater than about 1.5 Pa, and more preferably greater than 2.5 Pa (reaching approximately 2.8 Pa in certain embodiments).

In certain embodiments, the distance between the two cylindrical elements is whatever distance is required for the variable pressure geometry between them. In embodiments, the distance can be between 5 mm and 10 mm where the diameter of the endoscope channel to be cleaned is between 4 mm and 4.5 mm. In other embodiments, the distance can be a ratio to the diameter of the endoscope channel, for example, less than 4:1, or less than 2:1, or less than 1.5:1, or other ratios (distance:endoscope channel diameter).

The diameter of the cylindrical elements can be designed to avoid deflection of the proximal and distal end 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 those with pull-through cleaners that are as large as 5.2 mm in diameter, but are inevitably buckled to be applied in and advance through channels ranging in size from 2.8 mm to 5.0 mm in diameter. In an embodiment, the diameter of the cylindrical elements is between 1.0 and 1.23 times the diameter of the channel to be cleaned or dried to keep the cleaning/drying device 200 centered in the channel to be cleaned with minimal or limited deflection of the ends of these elements. In addition to this, a deflection equation can be used to obtain the optimal cylindrical elements.

If the diameter of the cylindrical element is too large compared to the channel size, this can result in ineffective cleaning or drying due to gaps within the cylinder, deflection of the cleaning/drying device, and resistance forces that are too great to consistently keep the cleaning/drying device 200 pulled through the channel, among other problems. The material selected can also affect this outcome. In an embodiment, the 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.

In an embodiment, the dimensions of the cleaning/drying device 200 can allow for advancement of the cleaner from the distal end without the cleaner catching on the elevator of the duodenoscope or ultrasound endoscope, which is an issue with current bristle brush and pull-through cleaners, but the dimensions of the cleaning/drying device 200 can allow for passage through the endoscope channel in the opposite direction from proximal to distal.

In an embodiment, the cleaning and/or drying device 200 may have one or more absorbent sponges positioned at the front or end of the cleaning and/or drying element 300 or between one or more of the cylindrical elements to absorb biological material, debris, and fluid. The absorbent sponge may be of a single cell configuration or may have multiple sponges with different cell configurations in providing wiping, absorbing, lifting, spreading, or a combination of cleaning fluid attributes. The absorbent sponge may be any material including polyurethane, polyvinyl alcohol, or other absorbent material. In an embodiment, the sponge is soft and atraumatic when submerged in the fluid and expands to a size that is at least the size of the channel to be cleaned, and in a preferred embodiment is larger than the channel to be cleaned. The sponge may be of any shape that fits into the channel of the endoscope and assists in cleaning and/or drying it, including but not limited to cylindrical, spiral, conical, triangular, square, or any combination thereof. In an exemplary embodiment, the sponge will have a pore size of about 200 PPC to 1500 PPC, preferably between about 200 PPC and about 600 PPC.

The design of the cleaning device 200 may vary based on the viscosity of the cleaning fluid used to clean the scope 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 scope for cleaning. In an embodiment, the target cleaning temperature is between 25 degrees Celsius and 35 degrees Celsius.

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 brushes can be of a length that is in a ratio of 1.0 to 1.4 times the diameter of the channel to be cleaned or dried. In an embodiment, the brushes are preferably made of an atraumatic polymer such as polyurethane with a thickness and durometer designed to limit trauma and damage to the channel wall while maintaining sufficient rigidity to remove contamination or moisture from the channel wall. The diameter of the brush element that contacts the channel wall can be any diameter, but in an embodiment, can be between .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 small limited distance into the biopsy channel. This shorter version can be of any length to clean or dry the initial entry point into the biopsy channel, but in a preferred embodiment, the length is between 4.5 cm and 15 cm. The brushing element, whether part of the cleaning element or a separate shorter version, can utilize nylon wire bristles or other bristles if arranged in a pattern that is effective for cleaning or drying and minimizes trauma to the endoscope channel. The gripping elements of the brush can have a larger profile at one end or in the center of the element to facilitate introduction into the biopsy channel.

In certain embodiments, the cleaning and/or drying device 300 can include multiple cylindrical elements with variable pressure elements therebetween, such as a series of five cylindrical element sets with a variable pressure element between each of the cylinders. These variable pressure elements can be the same or can be different to generate alternating pressure profiles. The multiple cylindrical elements with variable pressure elements therebetween can be more or less than five sets as appropriate for a given application.

7B, a cleaning and/or drying device 400 having a plurality of cleaning and/or drying elements 300 will now be described. As shown, each cleaning and/or drying element 300 includes proximal and distal end portions 302, 304 and a variable pressure region 306 therebetween, as described above. The proximal and distal end portions 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 into the distal end portion of the next cleaning and/or drying element, although it will be appreciated that other configurations are possible. For example, the cleaning and/or drying device 400 may have more than one cylindrical element disposed immediately adjacent to another cylindrical element with a spacing that does not generate a variable pressure, followed or alternatively preceded by a cylindrical element with a spacing between the next cylindrical element that generates a variable pressure between the cleaning and/or drying element 300 and the wall of the channel to be cleaned. In an embodiment, a series of cylindrical elements may be organized with various spacings that generate a variable pressure between the cylindrical elements and predetermined spacings that generate a constant pressure between the cylindrical elements.

The cylindrical/annular elements 302, 304 can be manufactured in any shape and size that contacts and at least partially fits the walls of the channel to be cleaned, including in embodiments cylindrical elements of decreasing or increasing diameter, cylindrical elements that flex to contact each other, cylindrical elements that flex to not contact another cylindrical element, or cylindrical elements that may or may not contact a variable pressure shape between cylindrical elements. The cylindrical elements do not have to be cylindrical, but they should be able to cooperate with the remaining elements of the cleaning and/or drying device 400 to help create a variable pressure result, i.e., they should have significant enough wall contact to help accelerate the fluid or air flow and thereby create a variable pressure area to direct the cleaning fluid or air against the channel wall by hydrodynamic or pneumatic forces.

In certain embodiments, the cylindrical/annular elements 302, 304 can be any shape that keeps the device generally centered and prevents the above-mentioned deflection, with the preferred embodiment being a cylindrical shape with a reduced diameter distal end. When this type of misalignment, which is a problem with existing brush and pull-through cleaners, is created as the cleaner is pulled around the bends, corners, and junctions of the lumen, the brush and other elements are pulled to one side of the lumen, resulting in minimized, adversely altered, or lost contact between the lumen wall and the cleaning and/or drying element (whether a brush, pull-through cleaner, or other cleaner), with a detrimental effect on the effectiveness of the cleaning and/or drying technique. Placing a centering element at the front or rear of the device, or both, corrects this problem and provides more consistent and effective cleaning and/or drying, especially around bends, corners, channel junctions, and other complex areas inside an endoscope, other endoscopic instrument, or endoscopic device.

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

In an embodiment, each cleaning and/or drying element 300 is between 2.5 cm and 7.5 cm long, and the cleaning and/or drying device 400 includes multiple variable pressure zones separated by multiple 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 may include two additional cylindrical elements 402, 404 at its distal end.

7A, another embodiment of a cleaning and/or drying device having multiple cleaning and/or drying elements will now be described. As in the immediately preceding embodiment, each cleaning and/or drying element 300 includes a proximal end portion and a distal end portion, as described above, and a variable pressure region between the end portions. The proximal and distal end portions are preferably cylindrical elements having an outer diameter substantially the same as the inner diameter of the lumen to be cleaned (as 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 into the distal end portion of the next cleaning and/or drying element, although it will be appreciated that other configurations are possible.

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 therefore do not include the variable pressure region discussed above.

The cleaning and/or drying device may further include a centering element 424 at either or both of its proximal and distal end portions. The centering element 424 serves to center the navigation element 301 and the cleaning and/or drying device as the cleaning and/or drying device is pulled or pushed through the lumen, around kinks, and through corners and other complex areas including junctions of multiple lumens and internal channels to be cleaned within an endoscope or other instrument. In embodiments, the centering element 424 may be smaller than the diameter of the lumen advanced through the device, but may have a size significant enough to prevent misalignment and deflection of the navigation element 301 to one side or another of the lumen as the navigation element 301 is navigated, including when the navigation element 301 is pulled or pushed simultaneously with the cleaning and/or drying device, around bends, corners, and junctions (including Y-junctions) of various lumens.

The centering element 424 can be any shape that keeps the device approximately centered and prevents this deflection, with the preferred embodiment being a cylindrical shape with a reduced diameter distal end. When this type of misalignment, which is a problem with existing brush and pull-through cleaners, is created as the cleaner is pulled around curves, corners, and junctions of the lumen, the brush and other elements are pulled to one side of the lumen, resulting in minimized, adversely altered, or lost contact between the lumen wall and the cleaning and/or drying element (whether a brush, pull-through cleaner, or other cleaner), with a detrimental effect on the effectiveness of the cleaning and/or drying technique. Placing the centering element at the front or rear of the device, or both, corrects this problem and provides more consistent and effective cleaning and/or drying, especially around curves, corners, channel junctions, and other complex areas inside an endoscope, other endoscopic instrument, or endoscopic device.

In some embodiments, the centering element (424) can include a series of shaping elements protruding from the elongate member or navigation member. The series of shaping elements can include, for example, posts, spikes, or other protrusions extending radially outward from the elongate member and sized to substantially center the elongate member and/or drying/cleaning element within the interior channel of the endoscopic device.

In a preferred embodiment, the centering element 424 has a diameter or height that is between 50 and 90 percent of the diameter of the lumen to be cleaned, and more preferred embodiments have a diameter or height that is between 70 and 85 percent of the diameter of the lumen to be cleaned. The centering element 424 can be any shape that maintains the centering of the cleaning and/or drying elements as they navigate through the channel. In embodiments, the shapes include cylindrical, conical, and spherical, and the centering element can be located in a distal section of the device, at the distal and proximal ends, between the cleaning and/or drying members, or at the proximal end, particularly as appropriate to assist in centering the cleaning and/or drying elements as they navigate around bends in the lumen, across Y-junctions, and other aspects.

7C, another embodiment 800 of the cleaning and/or drying device will now be described. As shown, the device 800 includes a plurality of cleaning and/or drying elements 300, each including proximal and distal end portions 302, 304 and a variable pressure region 306 between the end portions, as described above. The proximal and distal end portions 302, 304 are preferably cylindrical elements having an outer diameter substantially the same as the inner diameter of the lumen to be cleaned (as discussed above). In this embodiment, the cleaning and/or drying elements are coupled to each other at the proximal and distal end portions.

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 any shape that keeps the device approximately centered and prevents the deflection described above, with the preferred embodiment being a cylindrical shape with a reduced diameter distal end. Placing centering elements at the front or rear of the device, or both, corrects this problem and provides more consistent and effective cleaning and/or drying.

In this embodiment, the device 800 further includes a proximal tip element 802 and a proximal cylindrical centering element 804 disposed about the variable pressure region 306. The element 804 is preferably disposed about the constriction section 308 of the pressure region 306 between the divergence section 312 and the throat section 310 (see FIG. 4 and the above description of these elements).

The centralizing element 804 is disposed around the pressure regions 306, rather than at the proximal tip of the device (as in the embodiment of FIG. 7B). The centralizing element 804 is sized such that its outer surface contacts the inner surface of the lumen of the endoscopic device. As the device 800 is withdrawn or pushed through the lumen, the centralizing element 804 engages the inner surface of the lumen and displaces (cleans) any biological material and/or displaces (dries) moisture on this surface, moving these materials forward with the device 800. If the displaced biological material or moisture does not move forward, it is taken up by one of the pressure regions 306, as described above.

27 shows a kit 900 including a water bottle 902 with a straw 904 and a cleaning and/or drying device 910 for the straw 904. In this embodiment, the device 910 can be used to clean and/or dry the interior surfaces of drinking vessels and their components, such as drinking straws, drinking containers, water containers, bottles, thermoses, suckers, water jugs, glass bottles, baby bottles, water bottles, and insulated drinking vessels, and drinking straws for any of these vessels.

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

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 any shape that keeps the device approximately centered and prevents the deflection described above, with the preferred embodiment being a cylindrical shape with a reduced diameter distal end. Placing centering elements at the front or rear of the device, or both, corrects this problem and provides more consistent and effective cleaning and/or drying.

In this embodiment, the device 910 further includes a proximal tip element 908 and a proximal cylindrical centralizing element 906 (formed proximal to the proximal-most 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 acts to guide the device 910 through the straw 904 and displace moisture and/or biological material from the interior surfaces of the straw, thereby cleaning and/or drying those surfaces. In certain embodiments, the device 910 can include a distal tip element (not symbolized) having substantially the same design as the proximal tip element 908.

8 illustrates a system 450 for advancing a cleaning and/or drying device 400 through one or more lumens of an endoscopic device. As described above, the cleaning and/or drying device 300 is coupled to a navigation device 301, which may include, for example, an elongated wire, tube, filament, or similar component that is flexible but sufficiently rigid to be advanced through the lumen. The navigation device 301 is coupled to a retraction element 454, which may include, for example, a flexible silicone or plastic tube having a length sufficient to pass through the entire lumen of an endoscope or the like.

As shown in FIG. 9, the extraction element 454 can be shaped to provide frictional resistance such that the navigation device 301 can be advanced into the tube, but friction makes it difficult to pull the device 301 away from the extraction element 454. In this manner, the extraction element 454 is withdrawn through the lumen of the endoscope, and the cleaning and/or drying element 300 follows the extraction element 301 through the lumen.

As shown in FIGS. 25 and 26, the system may further include a guide element (750 in FIG. 25 and 760 in FIG. 26) that assists in passing the cleaning and/or drying device 200 through certain difficult sections of the endoscope. In particular, the guide element prevents the navigation element from flexing and entering the wrong channel when passing through internal junctions between multiple channels, such as the Y-junction 38B between the suction channel 22 and the biopsy channel 38C. Alternatively, the guide device may be used to guide the cleaning and/or drying device through sharp kinks or bends in the endoscope lumen.

In use, the guide element 750 or 760 can be inserted into one of the internal channels of the scope, 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 scope 10 to the proximal end of the biopsy channel 38C or the suction channel 22 to facilitate cleaning and/or drying in a manner that pulls debris away from the complex and difficult to clean distal end of the scope with a distal to proximal movement.

25, the guide element 750 comprises a hollow tube, such as a tubular sheath, that can be temporarily inserted into a desired branch of an internal junction between two channels such that a portion of the cleaning and/or drying device 200 enters or engages the guide element 750 as the guide element 750 is advanced through the channels, and deflects or penetrates the guide element 750 to avoid advancing the cleaning and/or drying device 200 into an unintended side of the internal channel junction or intersection. For example, when advancing the biopsy channel portion 38C of the endoscope 10 from the distal end to the proximal end of the channel (i.e., from the distal end of the shaft 14 to the biopsy valve 38), the navigation element will need to pass through the internal Y-junction 38B to advance back up 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 past the Y-junction 38B such that the navigation element of the cleaning and/or drying device 200 flexes at the Y-junction 38B and does not advance against the suction portion of the endoscope (see, e.g., suction valve 36 in FIG. 1 ) but instead passes into or engages the guide element and exits the end of the biopsy channel 38C.

In a similar manner, the guide element 750 can be inserted through the suction valve 36 and advanced slightly past the internal Y-junction 38B so that 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 can occur without potential deflection of the navigation element at the internal Y-junction 38B.

The guidance element 750 can be used to assist in advancing the cleaning and/or drying device 200 around sharp internal kinks in the internal channel of the endoscope, such as the exit of channel 22 in FIG. 1, as needed, and to assist in advancing the navigation element or cleaning and/or drying element as needed for other auxiliary purposes.

In certain embodiments, the guide element 750 is tubular or cylindrical with an outer diameter smaller than the inner diameter of the internal lumen (e.g., biopsy channel 38), which 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 match as closely as possible the diameter of the endoscope channel up to the internal Y-junction 38B or other internal area of the endoscope 10, and the length extending to or past the junction 38B can be between 8 cm and 20 cm. Furthermore, for 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.

In an embodiment, the guide element 750 may include a beveled tip to better conform to the shape of the multi-channel interior junction in the scope. In an embodiment, the proximal end of the guide element 750 may have a flange that is larger than the entrance opening to the particular scope channel into which the navigation element is inserted, so that the navigation element cannot be fully advanced into the channel, thereby making withdrawal difficult. In an alternative embodiment, the guide element 750 may not have a flange, but may have a marker, including, for example, a pad printed or other line that defines the maximum recommended point of advancement of the navigation element into the scope channel.

26 shows another embodiment 760 of a guide element comprising a substantially circular rod with a beveled distal tip so that the elongated navigation member 301 can be threaded from the distal end of the scope back to the aspiration valve opening while being deflected into the biopsy channel 38C at the Y-junction 38B. In an embodiment, the proximal end of the guide element 760 can have a flange larger than the entrance opening to the particular scope channel into which the navigation element is inserted so that the navigation element cannot be fully advanced into the channel, thereby making withdrawal difficult. It can also include a beveled cut at its distal end to more closely match the shape of the multi-channel internal junction within the scope.

10 illustrates another embodiment of a cleaning and/or drying device 500 having multiple 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 constriction portion 510 that slopes downward, followed by a throat portion 512 that slopes upwardly back against the lumen wall. As shown, the cleaning and/or drying element 502a includes an additional portion 514 that also includes a constriction portion and a throat portion, forming two separate variable pressure elements within the 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 multiple cleaning and/or drying elements, each including multiple variable pressure regions. Alternatively, each of the cleaning and/or drying elements can include only one variable pressure region, as shown for cleaning and/or drying element 502b. As with the prior embodiment, the combination of these sections creates a variable pressure that induces high shear stresses on the lumen wall.

11A-11D show other configurations for the variable pressure region of the cleaning and/or drying element. In FIG. 11A, the cleaning and/or drying element 560 includes a converging section 562 having an angle between the section 562 and the throat 566 that is greater than the angle between the throat section 566 and the diverging section 564. FIG. 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 that is formed to feed directly into the diverging section 574 (i.e., angled relative to the internal lumen and then angled back inward without having a central cylindrical throat section).

11C and 11D show a cleaning and/or drying element 550 that includes more than one throat section 552, thereby creating multiple high pressure regions. Additionally, each of the cleaning and/or drying elements in the series can have a different configuration. As shown, in some cases a cleaning and/or drying element having a single throat section can be followed by one having multiple throat sections, or vice versa.

12 shows yet another embodiment 600 of a cleaning and/or drying device including 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 created by the cleaning and/or drying element 602 in the lumen. Delivering fluid into the variable pressure region increases pressure in this region, which increases fluid or pneumatic forces against the inner wall of the lumen being cleaned.

The cleaning and/or drying device 400 can be non-sterile or disinfected or sterilized using a suitable sterilization method, including electron beam, gamma, ethylene oxide gas, hydrogen peroxide, or steam, etc. In the event that the device 400 is used for drying, it will typically be sterilized.

The material for the navigation element 301 can be any material that is sufficient to navigate through the channel to be cleaned and that can manage the pull-out forces associated with advancing the cleaning and/or drying element 300 through the channel to be cleaned. This includes all metals and polymer-based materials, including stainless steel wire, nitinol, and other metals. Additionally, this includes all polymer-based materials, whether in monofilament form, extruded tubing, braid, or any other form sufficient to facilitate advancing the cleaning and/or drying element 300 through the channel to be cleaned. In a preferred embodiment, the navigation element 301 is a monofilament having a diameter of at least 1 mm, including nylon, polyamide, polyurethane, PET, or other polymeric material. The navigation element 301 can include a gripping element at one end to facilitate gripping and threading 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 grip on the navigation element 301.

In an alternative embodiment, the navigation element 301 includes one or more internal channels that allow for the injection of cleaning fluid or air down the navigation element 301 to one or more ports, and also allows for the aspirating of fluid if necessary. An injection port may be present in the cleaning/drying device 300 for the discharge of fluid or air advanced by the navigation element 301, allowing the cleaning fluid or air to be injected into the cleaning device 200 by the navigation element 302 to further modify and increase the hydrodynamic pressure of the cleaning fluid against the channel walls. In an embodiment, the navigation element 301 and the cleaning element 302 may further contain one or more suction channels that may be used to more rapidly circulate the cleaning fluid or air and/or to force fluid through the suction channels to extract debris and fluid or moisture.

In certain embodiments, the navigation element 301 is attachable to the cleaning and/or drying element 300 by permanent attachment, which may be by molding, overmolding, two-shot molding, glue, or other means to create an attachment between the navigation element and the cleaning and/or drying element where the two elements are fixed or affixed for use. In preferred embodiments, the navigation element 301 is separately attachable, and in certain embodiments, is attachable and separable, such that the navigation element 301 can be attached from one end of the channel and out of the channel at the other end, and then attached to the cleaning and/or drying element 300. The attachment means may be any method for the intended use, and may include, by way of example, interlocking elements, compression fittings, sliding and locking mechanisms, hook-and-loop mechanisms, insert and twist mechanisms, or variations and alternative combinations for the diameter and shape of the navigation element and the cleaning and/or drying element.

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 barbs 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 barbs 410 to fit into an 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 into grooves 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 appreciate 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, flattened monofilaments, wires, strings, or filaments coupled in releasable or non-releasable knots, crimping, press-fit elements, protrusions that engage holes, channels, or other openings, heat staking, heat bending, heat punching, hooks, snap-on elements, and the like.

In a method according to certain embodiments, the navigation element 301 is advanced through a lumen of an endoscopic instrument, such as the biopsy channel 50 of the endoscope 10. The lumen is filled or partially filled with a fluid, such as an enzymatic detergent or other cleaning fluid, which acts to initially clean and/or disinfect the lumen to remove at least a portion of biological material and other pathogens from the lumen. With a distal end portion of the navigation element 302 threaded through a 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.

After attaching the cleaning and/or drying element 300 to the navigation element 301, the navigation element 301 is withdrawn through the lumen of the instrument. In certain embodiments, the device 200 includes a withdrawal cable configured to withdraw or advance the elongate shaft 301 within the internal lumen within the endoscope 10. The device may include an energy source and a motor for advancing and/or withdrawing the navigation element 301. Of course, it will be appreciated that the navigation element 301 may be manually translated through the internal lumen by a proximal handle or a suitable actuator (i.e., not a motor).

As the navigation element 301 is withdrawn through the lumen, each cleaning and/or drying element 300 generates 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 walls of the cleaning and/or drying element 300, thereby accelerating the fluid against the inner wall of the lumen, thereby generating greater fluid forces against the walls (as discussed in more detail above). This increased fluid force provides more effective cleaning and/or drying than conventional devices.

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

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

Also provided are kits for use in cleaning and/or drying endoscopic instruments. The kits may include any of the cleaning and/or drying devices described above, and may 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 skilled in the art. Additionally or alternatively, the kits may include various other devices used in the cleaning and/or drying procedures, such as cleaning brushes, swabs and/or sponges, enzymatic cleaning agents, disinfectants, and other devices and agents for sterilizing and/or disinfecting medical devices, scope drying agents, 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 site, and a contaminant bag, in any combination.

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-mentioned embodiments. The kit can include a non-sterile cleaning device and a sterile drying device. Alternatively, the kit can include one device that acts to clean and dry the internal lumen of the endoscopic device. In embodiments, the cleaning device can be one color and the drying device can be a different color to make it easier for the user to distinguish the purpose of each device. This color coding helps identify the use of each device and helps clarify which devices are sterile after opening. Color differences can be applied to navigation elements, cleaning/drying elements, pad print lines, or other markers to clarify the different uses of each device.

In certain embodiments, the kit includes a cleaning device, such as one of the embodiments described above, and a drying device including an advancing element, which may be a filament, wire, tube, or other element capable of advancing into an interior channel, including long, curved, or other channels that are invaginated or difficult to access. In embodiments, the element may be gripped at an end after being pulled through the interior channel and then pulled through the channel as part of the drying process. Similarly, the advancing element may be advanced by pushing the element from the other end. The element may include a version that can advance air through the device into the channel, including locations that are removed well inside the channel and beyond the typical effect of forced air drying within the channel.

The drying member may include one or more substantially cylindrical members spaced apart from one another along the advancing member. The cylindrical members are configured to maintain contact with the channel walls to displace and remove any moisture as the advancing element advances through the channel. The advancing element may be advanced by being pushed, pulled, or by other means including rocking back and forth, advancing and withdrawing based on a pattern. The advancing element may be advanced through the endoscope by connection to an automated or mechanized method or any other means for moving the channel drying element through the channel to displace, absorb, and/or remove water by at least partial direct contact with the surface area to be dried.

In an embodiment, the drying member may include a series of one or more cylindrical squeegees designed to make wall contact with the inner walls of the channel to remove fluids and moisture from the channel. These cylindrical squeegees may be arranged in any manner effective to remove fluids and moisture from the channel, including arrangements of groups of two followed by groups of three or in reverse order, or other squeegee configurations, such as a group of one squeegee followed by a group of two, a group of two followed by a group of four, a group of three followed by a group of four, four in a row, five in a row, or any other number and configuration of squeegees effective to remove water and moisture and dependent on the diameter, length, curvature of the channel, junctions with other channels, and other factors.

In embodiments, certain of these squeegees can be of different heights to make the device more adaptable for use with different sized channels. For example, the device can have a squeegee with a diameter of 5 mm to 5.2 mm, followed by a smaller squeegee with a diameter between 2 mm and 2.2 mm, followed by another squeegee with a diameter of 3.8 mm to 4 mm to create variable wall contact across different channel sizes. In embodiments, the height and placement of the squeegee is not limited to this description, and these diameters, placements, squeegee thicknesses, and more will vary based on what is most effective for drying for a given channel drying application.

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 1 mm, 1.25 mm, 1.5 mm, 2 mm spacing, narrow 1.25 mm spacing followed by a 4 mm gap, followed by 1.25 mm to 1.5 mm spacing, or narrower, wider, or other more variable spacing that optimizes and promotes rapid and predictable channel drying. The spacing, diameter, alignment, and grouping of the drying elements, in embodiments, can vary based on the channel size, channel material, number of bends as it navigates from one to the other, number of junctions with other channels, channel dryer material if any, and other factors unique to a given channel drying application.

The thickness of the squeegees, disks, and fins is any thickness that aids in drying the channel and aids in positioning the fins and squeegees to be dried and, in embodiments, cleaned. In embodiments, this thickness includes squeegee and fin thicknesses between 0.2 mm and 0.5 mm, other variations having thicknesses between 0.5 mm and 1.0 mm, and other different values having a reduced thickness that is thicker at the base of the squeegee or fin and tapers as it approaches the channel wall to improve the flex and conformity of the element to the channel wall while providing support around the advancing element, as well as a predetermined stiffness and flexibility.

In an embodiment, the innovation of the present invention includes a centering element so that the drying element remains centered as it is advanced through the channel to be dried. This element prevents the squeegee or cleaning element from losing contact with the walls of the channel to be cleaned, enhancing the drying action. The centering element is any shape that keeps the drying element in the relative center of the channel as it is advanced so that any lateral movement required to navigate through the channel, particularly around bends, does not cause the drying element to flatten against the walls and thereby lose contact with the channel walls to be dried. 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 located anywhere on the advancing element or on the drying element, and can include multiple centering elements to enhance and maintain drying and cleaning performance.

[Example 1]
Applicant has performed several tests comparing various properties of the cleaning device disclosed herein (labeled the Venturi® Cleaner in Figures 16-18) with a commercially available cleaning brush, the Pull Thru® Cleaner from Cantel Medical. The Pull Thru® Cleaner is designed to have five cylindrical fins placed very close to each other, with two of the fins clumping together leaving a large space followed by three additional fins that also clump together. The fins are a flexible polymer overmolded onto a rod of hard material that is used to advance the cleaner down the scope biopsy channel from the proximal end to the distal end of the scope while the scope is submerged in the cleaning fluid. The space between each clump of fins is uniform and the polymer between the fins is of a thin uniform thickness that is overmolded to adhere to the cylindrical monofilament.

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 comparable speeds (i.e., approximately 30 centimeters per second). Computational pressure flow modeling was performed to measure the positive pressure cleaning area of both devices.

As shown in FIG. 16, the Pull Thru® cleaner 700 generated an intermediate pressure of about zero (0) Pa between the proximal end 702 and the distal end 704 of each cleaning element 706. The cleaning device 200 disclosed herein (Venturi® cleaner) generated an intermediate pressure of about 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. Furthermore, the cleaning device 200 disclosed herein had a peak pressure of greater than 50 Pa over a significant portion of the cleaning element 300 (all over the throat region 310), with a maximum pressure of 150 Pa. In contrast, the Pull Thru® cleaner 700 had a peak pressure of more than 50 Pa in a very small portion of the cleaning element 706 adjacent the end 704, and only a maximum pressure of 75 Pa. Thus, the cleaning/drying device 200 disclosed herein produces peak pressures that are dramatically higher than the Pull Thru® cleaner 700 and extend over a longer device length.

17, the Pull Thru® cleaner 700 has a length between the proximal end 702 and the distal end 704 of about 3.85 mm, while the cleaning/drying device 200 disclosed herein has an average distance between the cylindrical elements 302 and 304 of about 9.25 mm. The peak cleaning pressure coverage area ("PPAC®") was considered to be the distance within each cleaning element where there is a pressure of cleaning fluid or air greater than 50 Pa. The Pull Thru® cleaner 700 has a peak cleaning area of about 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 about 3.77 mm or 41% of the total distance between the cylindrical elements 302 and 304.

18, the positive pressure cleaning zone ("+PAC") was defined as the distance down the cleaning/drying element where the pressure of the cleaning fluid or air against the inner lumen wall was positive or greater than zero. As shown, the Pull Thru® cleaner 700 had a +PAC of about 0.52 mm or 13.5% of the total distance between ends 702 and 704. The cleaning device 200 disclosed herein had a +PAC of about 7.54 mm or about 81% of the length between cylindrical elements 302 and 304. Thus, the majority of the space between the cleaning/drying device 200 and the inner lumen wall had a positive cleaning pressure.

[Example 2]
Cleaning the internal channel of a duodenoscope or other endoscope is an important part of the major manual cleaning steps that must be performed as part of reprocessing a scope to return the reusable endoscope to a safe and substantially usable condition. FDA guidelines for this part of the overall reprocessing process preferably include testing either the actual scope channel or a representative example with a proteinaceous soil with blood. The preferred approach is to inject the soil into the channel, allow the soil to distribute evenly, and then leave it to dry or until a worst case time frame is reached. Once this condition is reached, a channel cleaner is run through to flush the channel at a level less than that normally used as part of scope reprocessing, and the contamination level is then evaluated.

Concentrated protein soil spiked with sheep's blood was prepared by Mycoscience, an independent testing laboratory that prepared and performed the tests. The protein concentration was 19,421 ug/ ^cm2 , which is the upper end of the duodenoscope channel contamination range. A 4.2 mm x 180 cm PTFE duodenoscope channel was used for each test, and 10 mL of soil was injected into the test channel, the ends of the channel were capped, and the channel was rocked back and forth and rotated to distribute the soil evenly within the test channel. The contaminated test channel was left in the container with the ends capped to prevent soil leakage therethrough for 2 hours, which is twice the 1 hour limit used by endoscope manufacturers for reprocessing tests as a worst case approach.

After the two hour period was completed, 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 an endoscope channel cleaner was advanced through the test channel to clean the contaminated endoscope test channel. The detergent was flushed out of the endoscope test channel at a level significantly reduced from that recommended by the endoscope manufacturer in accordance with FDA guidelines. The endoscope test channel was then extracted with 25 mL of extraction media, and the residual protein counts were determined.

To ascertain contamination levels, a test was conducted comparing the Pull Thru® endoscope channel cleaner with the Venturi® endoscope channel cleaner and a positive control test channel that was extracted without cleaning with the channel cleaner. The positive control shows a protein concentration level of 19,421 ug/ ^cm2 for this test. The Venturi® cleaner reduced contamination levels to .08 ug/ ^cm2 in this test. The results for the Pull Thru cleaner reduced contamination levels to 13 ug/ ^cm2 , over 162 percent higher.

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

In certain embodiments, the device 100 includes a retraction cable configured to retract or advance the elongate shaft 102 within an internal lumen within the endoscope 10. The device may include an energy source and a motor for advancing and/or retracting the elongate shaft 102. Of course, it will be appreciated that the elongate shaft 192 may be manually translated through the internal lumen by a proximal handle or suitable actuator (i.e., not a motor).

Preferably, the cleaning/drying member 104 comprises a flexible material designed to fit within the interior lumen of an endoscope or other endoscopic instrument and absorb or remove any debris or biological material present within the lumen. As shown, the cleaning/drying member 104 has an outer diameter 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 the biological material, tissue, or other debris, and moisture, one potential area for pathogens to survive and grow within the instrument is eliminated.

Preferably, the cleaning/drying member 104 comprises a material that substantially absorbs biological material, tissue, or other debris, and moisture from the interior surfaces of the instruments without creating defects, such as scratches, on those surfaces. This allows those instruments to be reused multiple times without gradually increasing the difficulty of cleaning and/or sterilizing them.

As shown in FIG. 20, preferably, the cleaning member 104 includes 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 greater 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.

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 fluid. In this embodiment, the cleaning member 104 can be advanced into the lumen in a relatively dry state and then allowed to absorb fluid within the lumen such that the cleaning/drying member 104 expands to a diameter equal to or greater than the inner diameter of the lumen.

Endoscopic instruments often contain crevices, scratches, seams, or other irregularities in the inner surface of the lumen (see FIG. 3). Preferably, the cleaning/drying member 104 is configured to expand into these crevices and irregularities where it contacts the entire surface. In this manner, the cleaning member 104 can absorb biological material, fluid, or tissue from within these small crevices, thereby removing significantly more biological material from the instrument than conventional cleaning mechanisms.

The cleaning member 104 may comprise any material that absorbs biological material, 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 comprises a sponge-like material, such as cellulose, dried cellulose, natural cellulose, and/or compressed cellulose. In an exemplary embodiment, the material comprises 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 ability to expand 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.

In the embodiment shown in FIG. 19, the cleaning/drying member 104 extends outwardly from one segment of the shaft 102 such that the cleaning/drying member 104 absorbs biological material and moisture from the inner surface of the lumen as the shaft 102 is advanced or retracted through 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 FIG. 22A). In an exemplary embodiment, the (the) cleaning/drying member(s) comprise a material configured, alone or in combination, to absorb a volume of material at least equal to the volume of the lumen.

In certain embodiments, the cleaning/drying device 100 further includes a programmable motor (not shown), which may be part of or separate from the elongated shaft 102. The programmable motor is designed to withdraw the shaft 102 from the internal lumen of the endoscope 10 at a fixed or variable speed. Alternatively, the motor may be programmed with a specific algorithm that corresponds to a certain cleaning or drying objective. In one embodiment, the motor is programmed to withdraw the elongated shaft 102 at a fixed speed based on a predefined cleaning or drying time required to completely absorb and remove the biological material from the internal lumen. In an alternative embodiment, the motor is programmed to withdraw the elongated shaft 102 in a series of separate steps, i.e., holding the shaft in place for a specified period of time, then withdrawing the shaft a specified distance, and repeating these steps until the shaft is withdrawn and the cleaning or drying procedure is completed.

In an embodiment, the elongate shaft 102 is advanced or retracted through a lumen of an endoscopic instrument, such as the biopsy channel 50 of the endoscope 10. The lumen may be filled or partially filled with a fluid, such as an enzymatic detergent or other cleaning fluid. The fluid acts to initially clean and/or disinfect the lumen to remove at least a portion of the biological material and other pathogens from the lumen. Additionally, the fluid may be absorbed by the sponge, causing the sponge to expand outwardly to the inner surface of the lumen. In a preferred embodiment, the sponge will expand to a diameter greater than the inner diameter of the lumen such that the lumen at least partially restrains the sponge. This ensures that there is sufficient pressure between the sponge and the inner wall of the lumen such that the sponge will expand into any crevices, cracks, or other imperfections in the wall of the lumen, allowing the sponge to absorb and/or remove biological material and fluids from the lumen as the elongate shaft 102 is advanced or retracted through the lumen.

In one embodiment, the method includes measuring the volume of the lumen and providing a cleaning/drying member configured to absorb an amount of material 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 of the ends of the lumen is sealed so that fluid cannot pass therethrough, and the opposite end is left open. Fluid is then pumped into the lumen until the lumen is completely full (i.e., any further fluid pumping would result in fluid spilling out of the open end). The fluid is then drained into a suitable measurement container, and the volume of fluid that occupied the lumen is determined.

With the volume of the target lumen measured, a cleaning/drying member 104 is provided that has the capability to absorb at least the volume of fluid that is believed to fill 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 there is substantially no fluid contained therein. The dried cleaning member 104 or scope is then placed into a container that contains the larger volume of fluid already measured. The cleaning member 104 is left to absorb the fluid until it is completely saturated, the difference in the fluid volume in the container providing the maximum absorption capability of the cleaning member.

After the cleaning member 104 has passed through the entire lumen, air is injected into the lumen to clear any remaining disinfectant solution from the lumen and dry the lumen. To facilitate drying, alcohol, such as 70% ethyl alcohol or isopropyl alcohol, can be pumped into the lumen.

21B, another embodiment will now be described. As shown, a cleaning/drying member 108 extends outwardly from the shaft 102 along substantially 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 greater than the length of the lumen to be cleaned and dried. Preferably, the cleaning/drying member 104 comprises a material configured to absorb a volume of material at least equal to the interior volume of the lumen.

The cleaning/drying member 104 can perform the function of centering the elongate shaft 102 within the internal lumen of the scope 10. Alternatively or additionally, the shaft 102 can further include a centering device (not shown) at the distal end for keeping the cleaning/drying device 104 optimally positioned within the lumen such that absorption of biological material is substantially uniform throughout the lumen of the scope 10.

The cleaning device 100 may 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 may include PCT and microarray-based sensors, optical sensors (e.g., bioluminescence and fluorescence), piezoelectric sensors, potentiometric sensors, amperometric sensors, conductometric sensors, or nanosensors, and the like. The shaft 102 may further include an indicator, such as a display coupled to the sensor and configured to indicate the presence or absence of biological material, pathogens, liquids, or other particulate matter detected by the sensor. The indicator may be any suitable chemical indicator that has been validated for cleaning and/or sterilization procedures and that undergoes a physical or chemical change visible to the human eye after exposure to certain parameters. The indicator and sensor may be part of the same device or separate from each other.

According to another aspect, some embodiments may include the ability to inject a disinfectant, cleaning chemical, or other fluid to achieve an additional germicidal effect prior to the cleaning member 104 or in relation to the absorption of biological material. The fluid may serve to lubricate the lumen for other reasons, including to facilitate easier withdrawal of the elongate shaft 102 and cleaning member 104 through the lumen, or to prolong the half-life of a chemical agent to act as a germicide or achieve other benefits.

22 and 23, another embodiment will now be described. As shown in FIG. 22, the cleaning/drying device 200 includes an elongated shaft 202 and a cleaning/drying member 204 disposed at a distal end portion thereof. As in the immediately preceding embodiment, the shaft 202 may 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 an internal lumen within the endoscope 10. In this exemplary embodiment, the shaft 202 will have an outer diameter ranging from about 0.5 mm to about 5 mm, preferably about 1 mm to 4 mm.

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 comprises a material configured to remove tissue, biological material, or other debris from at least a portion of the inner surface of the lumen. By removing the biological material, tissue, or other debris, and moisture, one potential area for pathogens to survive and grow within the instrument is eliminated.

Preferably, the cleaning member 204 comprises a material having a roughness determined to substantially remove biological material, tissue, or other debris from the interior surfaces of the instruments without creating defects, such as scratches, on those surfaces. This allows those instruments to be reused multiple times without increasing difficulty in cleaning and/or sterilizing them.

The cleaning/drying member 204 includes an outer surface 210 that includes a material that is sufficiently smooth to minimize or completely avoid creating any scratches or other defects in the surface 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 low coefficients of friction. Thus, the outer surface 210 includes 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.

In the above-described embodiment, the cleaning/drying member 204 has a substantially annular cross-sectional shape designed to fit the outer circumferential shape of the internal lumen of the endoscopic instrument. However, it will be appreciated 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, square, and the like. Additionally, the cleaning/drying member 204 can include surface contours, such as protrusions, bristles, barbs, or roughened areas, to facilitate cleaning/drying the inner surface of the lumen. However, it will be appreciated that in embodiments, any such contours or bristles can be designed with a similar material as the overall cleaning member or multiple different materials.

In one embodiment, 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 can extend outwardly from a distal portion of the shaft 202 such that the cleaning/drying member 204 removes biological material from the inner surface of the lumen as the shaft 202 is advanced or retracted through 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 the entire length of the lumen of the endoscopic instrument.

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

Although several embodiments of this description are shown in the drawings, this description is not intended to be limited to these embodiments, as this description is intended to be as broad as the art will permit and to be read and understood. Those skilled in the art will appreciate that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments. Features illustrated or described with respect to one exemplary embodiment may 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. Thus, this description is intended to encompass all such alternatives, modifications, and variations. Moreover, those skilled in the art will recognize further features and advantages of this description based on the above-described embodiments. Thus, this description is not limited by what has been specifically shown and described, except as indicated by the claims.

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

Claims (75)

1. A drying device comprising:
an elongate member configured to advance through a lumen of the device;
at least one desiccant member coupled to a portion of the elongate member, the desiccant 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;
Including,
the central portion is shaped to create a pressure gradient along the central portion from the distal end portion to the proximal end portion;
Drying device. The drying device of claim 1, wherein the pressure gradient causes an increase in relative velocity between the drying member and the fluid and air in the lumen as the drying member advances through the lumen. The drying device of 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. the central portion of the desiccant member includes a converging section coupled to the proximal end portion, a diverging section coupled to the distal end portion, and a throat section connecting the diverging section and the converging section;
the throat section has a diameter smaller than the diameters of the proximal and distal end portions and larger than the diameters of the diverging and converging sections.
The drying device of claim 1 . the converging section increases in diameter from the proximal end portion to the throat section, and the diverging section decreases in diameter from the throat section to the distal end portion;
The throat section is substantially cylindrical.
The drying device according to claim 4. The drying device of claim 4, wherein the constriction section defines an angle with the throat portion that is from about 4 degrees to about 85 degrees. The drying device of claim 4, wherein the constriction section defines an angle with the throat portion that is about 15 degrees to about 30 degrees. The drying device of claim 4, wherein the diffusing section defines an angle with the throat portion that is from about 4 degrees to about 85 degrees. The drying device of claim 4, wherein the diffusing section defines an angle with the throat portion that is about 15 degrees to about 30 degrees. The drying device of claim 1, wherein the drying member is removably coupled to the elongated member. The desiccant device of claim 1, wherein the desiccant member has one or more centering elements positioned on either end of the desiccant member to center the desiccant member as it advances through the lumen. The desiccant device of claim 1, wherein the desiccant member includes first and second cylindrical centering elements positioned on either end of the desiccant member for centering the desiccant member as it advances through the lumen. a second desiccant member coupled to a second portion of the elongate member; and a third desiccant member coupled to the second desiccant member;
each of the first and second desiccant members including 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 create a pressure gradient along the central portion from the distal end portion to the proximal end portion;
The drying device of claim 1 . the second desiccant 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;
the central portion is shaped to create a pressure gradient along the central portion from the distal end portion to the proximal end portion;
The drying device of claim 13. The desiccant device of claim 13, wherein the proximal end portion of the second desiccant member is coupled to the distal end portion of the first desiccant member. The desiccant device of claim 1, further comprising one or more cylindrical elements sized to contact the walls of the lumen and positioned on the rear ends of the first and second desiccant members. The desiccant device of claim 1, wherein the distance between the proximal and distal ends is about 1 to about 4 times the inner diameter of the lumen. The device of claim 1, comprising an endoscopic instrument. The device of claim 18, wherein the endoscopic instrument comprises an endoscope. The device of claim 1, comprising a drinking straw for a beverage container. The device of claim 1, comprising a tube in a CPAP machine. 1. A desiccant device for use with an endoscopic instrument, comprising:
an elongate member configured to translate through a lumen within the endoscopic instrument;
at least one desiccant element coupled to a portion of the elongate member, the desiccant element including 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 having a smaller outer diameter than the proximal end portion and the distal end portion;
Including,
the central portion is shaped to increase the force exerted by fluid within the lumen against an inner wall of the lumen as the clearing member advances through the lumen.
Drying device. 23. The drying device of claim 22, wherein the force creates 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. 23. The drying device of claim 22, wherein the force creates a shear stress of at least about 5 Pa in at least one area between the distal end portion and the proximal end portion of the cleaning element. 23. The drying device of claim 22, wherein the force creates an average pressure of at least about 10 Pa between the proximal end portion and the distal end portion of the cleaning element. 23. The drying device of claim 22, wherein the central portion has a distance and the force creates a pressure of at least 50 Pa in at least 25% of the distance between the proximal end portion and the distal end portion of the cleaning element. 23. The drying device of claim 22, wherein the central portion has a distance and the force creates a pressure greater than 0 Pa in at least 50% of the distance between the proximal end portion and the distal end portion of the cleaning element. the central portion of the desiccant member includes a converging section coupled to the proximal end portion, a diverging section coupled to the distal end portion, and a throat section connecting the diverging section and the converging section;
the throat section has a diameter smaller than the diameters of the proximal and distal end portions and larger than the diameters of the diverging and converging sections.
23. The drying device of claim 22. 29. The drying device of claim 28, wherein the converging section increases in diameter from the proximal end portion to the throat section, and the diverging section decreases in diameter from the throat section to the distal end portion. 29. The drying device of claim 28, wherein the converging section defines an angle with the throat portion that is from about 4 degrees to about 85 degrees. 29. The drying device of claim 28, wherein the converging section defines an angle with the throat portion that is about 15 degrees to about 30 degrees. 29. The drying device of claim 28, wherein the diverging section defines an angle with the throat portion that is from about 4 degrees to about 85 degrees. 29. The drying device of claim 28, wherein the diffusing section defines an angle with the throat portion that is about 15 degrees to about 30 degrees. 1. A desiccant device for use with an endoscopic instrument, comprising:
an elongate member configured to translate through a lumen within the endoscopic instrument;
at least one desiccant element coupled to a portion of the elongate member, the desiccant element including a distal end portion and a proximal end portion and a central portion between the distal end portion and the proximal end portion;
Including,
the central portion includes a first section coupled to the proximal end portion, a second section coupled to the distal end portion, and a third section coupling the first and second sections, the third section having a diameter smaller than a diameter of the proximal end portion and the distal end portion and larger than a diameter of the first and second sections;
Drying device. 35. The drying device of claim 34, wherein the first section tapers inwardly from the second section to the proximal end portion. The drying device of claim 34, wherein the third section tapers inwardly from the second section to the distal end portion. 35. The desiccant device of claim 34, 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 tapering inwardly from the cylindrical element to the third section. The desiccant device of claim 37, wherein the proximal end portion includes fins that taper outwardly in a distal direction. 35. The drying section of claim 34, wherein the first section defines an angle with the third section that is about 15 degrees to about 30 degrees. The drying section of claim 34, wherein the second section defines an angle with the third section that is about 15 degrees to about 30 degrees. 1. A kit for cleaning and drying an endoscopic instrument, comprising:
an advancing element configured to advance through a lumen within the endoscopic instrument; and at least one desiccant member coupled to a portion of the advancing element, at least a portion of the desiccant member shaped and configured to substantially maintain contact with a wall of the lumen as the advancing element advances through the lumen.
A drying device comprising:
an elongate member configured to advance through the lumen within the endoscopic instrument; and at least one desiccant member coupled to a portion of a second elongate member, the clearing 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, the central portion shaped to create a pressure gradient along the central portion from the distal end portion to the proximal end portion;
a cleaning device comprising:
Kit including: the desiccant 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;
the central portion is shaped to create a pressure gradient along the central portion from the distal end portion to the proximal end portion;
42. The kit of claim 41. The kit of claim 41, wherein the desiccant member comprises one or more substantially cylindrical members spaced apart from one another along the advancing member. The kit of claim 41, wherein the cylindrical member comprises an absorbent material. the cylindrical members include a first cylindrical member having a first diameter and a second cylindrical member having a second diameter;
The first diameter is greater than the second diameter.
42. The kit of claim 41. The kit of claim 41, wherein the advancement element comprises a filament, a wire, or a tube. The kit of claim 41, wherein the desiccant device further comprises a centering element configured to center the desiccant member within the lumen. The kit of claim 41, wherein the drying device is sterilized. 1. A method for drying one or more lumens within an endoscopic instrument, comprising:
advancing an elongate member including at least one desiccant member through the lumen within the endoscopic instrument;
generating a pressure gradient along a central portion of the desiccant member;
The method includes: The method of claim 49, wherein the pressure gradient causes an increase in relative velocity between the dry member and the fluid within the lumen as the dry member advances through the lumen. The method of claim 49, wherein the pressure gradient causes an increase in shear stress between the fluid in the lumen and the inner wall of the lumen. the central portion of the desiccant member includes a converging section coupled to the proximal end portion, a diverging section coupled to the distal end portion, and a throat section connecting the diverging section and the converging section;
the throat section has a diameter smaller than the diameters of the proximal and distal end portions and larger than the diameters of the diverging and converging sections.
50. The method of claim 49. The method of claim 49, further comprising centering the desiccant member within the lumen as the desiccant member advances through the lumen. A kit comprising:
a beverage container including a drinking straw;
an elongate member configured to advance through a lumen of the drinking straw;
at least one cleaning member coupled to a portion of the elongate member and including a distal end portion and a proximal end portion and a central portion between the distal end portion and the proximal end portion;
Including,
the central portion is shaped to create a pressure gradient along the central portion from the distal end portion to the proximal end portion;
kit. The kit of claim 54, wherein the pressure gradient causes an increase in relative velocity between the clearing member and the fluid and air within the lumen as the clearing member advances through the lumen. The kit of claim 54, wherein the pressure gradient causes an increase in shear stress between the fluid and air in the lumen and the inner wall of the lumen. the central portion of the cleaning member includes a converging section coupled to the proximal end portion, a diverging section coupled to the distal end portion, and a throat section connecting the diverging section and the converging section;
the throat section has a diameter smaller than the diameters of the proximal and distal end portions and larger than the diameters of the diverging and converging sections.
55. The kit of claim 54. the converging section increases in diameter from the proximal end portion to the throat section, and the diverging section decreases in diameter from the throat section to the distal end portion;
The throat section is substantially cylindrical.
58. The kit of claim 57. 55. The kit of claim 54, wherein the cleaning device further comprises a tip element having a substantially cylindrical shape and sized to advance through the lumen of the drinking straw. A cleaning device for a beverage container, comprising:
an elongate member configured to advance through a lumen of the beverage container;
at least one cleaning member coupled to a portion of the elongate member and including a distal end portion and a proximal end portion and a central portion between the distal end portion and the proximal end portion;
Including,
the central portion is shaped to create a pressure gradient along the central portion from the distal end portion to the proximal end portion;
Cleaning device. The cleaning device of claim 60, wherein the pressure gradient causes an increase in relative velocity between the cleaning member and the fluid and air within the lumen as the cleaning member advances through the lumen. The cleaning device of claim 60, wherein the pressure gradient causes an increase in shear stress between the fluid and air in the lumen and the inner wall of the lumen. the central portion of the cleaning member includes a converging section coupled to the proximal end portion, a diverging section coupled to the distal end portion, and a throat section connecting the diverging section and the converging section;
the throat section has a diameter smaller than the diameters of the proximal and distal end portions and larger than the diameters of the diverging and converging sections.
61. The cleaning device of claim 60. the converging section increases in diameter from the proximal end portion to the throat section, and the diverging section decreases in diameter from the throat section to the distal end portion;
The throat section is substantially cylindrical.
64. The cleaning device of claim 63. The cleaning device of claim 63, wherein the converging section defines an angle with the throat portion that is from about 4 degrees to about 85 degrees. The cleaning device of claim 63, wherein the converging section defines an angle with the throat portion that is about 15 degrees to about 30 degrees. The cleaning device of claim 63, wherein the diverging section defines an angle with the throat portion that is from about 4 degrees to about 85 degrees. The cleaning device of claim 63, wherein the diverging section defines an angle with the throat portion that is between about 15 degrees and about 30 degrees. The cleaning device of claim 60, wherein the cleaning member has one or more centering elements positioned on either end of the cleaning member to center the cleaning member as it advances through the lumen. 61. The cleaning device of claim 60, wherein the cleaning member includes first and second cylindrical centering elements positioned on either end of the cleaning member, the first and second cylindrical centering elements for centering the cleaning member as it advances through the lumen. a second cleaning member coupled to a second portion of the elongated member; and a third cleaning member coupled to the second cleaning member;
each of the first and second cleaning members including 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 create a pressure gradient along the central portion from the distal end portion to the proximal end portion;
61. The cleaning device of claim 60. 72. The cleaning device of claim 71, wherein the proximal end portion of the second cleaning member is coupled to the distal end portion of the first cleaning member. 72. The cleaning device of claim 71, further comprising one or more cylindrical elements sized to contact the walls of the lumen and positioned on the rear ends of the first and second cleaning members. The cleaning device of claim 60, wherein the distance between the proximal end portion and the distal end portion is about 1 to about 4 times the inner diameter of the lumen. The cleaning device of claim 60, further comprising a tip element having a substantially cylindrical shape and sized to advance through the lumen of the drinking straw.

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