System and method for drying an endoscope device

Abstract

Provided are a device, a method, and a kit for cleaning and / or drying an endoscope instrument such as an endoscope. In one aspect, a drying device for use in combination with an endoscope instrument includes an elongate member configured to advance through an internal lumen within the endoscope instrument, and a drying member removably coupled to a portion of the elongate member. At least a portion of the drying member has an outer diameter larger than the outer diameter of the elongate member and can be shaped and configured to substantially maintain contact with the wall of the lumen as the elongate member advances through the lumen. The elongate member and the drying member are sterilized or disinfected, and the device channels sterilized and / or disinfected thereby are not impaired by the drying process.

Description

Technical Field

[0001] The present invention relates to a system and method for drying an endoscope device. [Cross - Reference to Related Applications] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 339,497, filed May 8, 2022, the entire contents of which are incorporated herein by reference for all purposes.

Background Art

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

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

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

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

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

[0007] Nearly all of these problems can be addressed through the use of new and relatively low-cost technologies and practices that were developed in response to these concerns, are applicable in the context of current workflows and procedures, and are environmentally friendly, particularly when compared to single-use endoscope options. These relatively low-cost technologies and practices include the use of single-use disposable tubing and valves instead of reusable tubing and valves, the use of sterile single-use endoscope shields that seal the area of the complex 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 methods, and the implementation of post-procedure culturing and monitoring to address other areas of concern.

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

[0009] Another significant need not met by using these instruments and this process relates to downstream problems associated with drying the instruments after the cleaning and / or disinfection or sterilization process is complete. Most, if not all, disinfection or sterilization techniques involve some element of liquid or gas delivery of the disinfectant or sterilant, and in most protocols this is followed by washing with a chemical such as water or sterile water to rinse and to assist in the evaporation of the chemicals used for removal and / or selection and in very limited cases disinfection or sterilization.

[0010] In all of these processes, the critical final stage after disinfection or sterilization is the drying stage of the instrument. With respect to the outer surface of a medical device, the aspects of this process are somewhat straightforward, but with respect to recessed areas, particularly relatively narrow and sometimes long channels, drying these areas is difficult, time-consuming, and unpredictable or inconsistent. Substantial drying failure negates the benefits of the overall reprocessing technique including the disinfection stage and / or sterilization stage. The reason is that wet surfaces promote the growth of pathogens and biofilms. Pathogens and biofilms cannot grow when the instrument is dry. Hydration is a central element in the growth of pathogens and biofilms, leading to nosocomial infections, drug-resistant infections, and other deadly infections. In non-medical applications, residual hydration affects the performance of the device and can ultimately expose the user to the growth of biofilms and pathogens that can even pose a risk of one or more pathogens.

[0011] Current drying techniques have applied some inconsistent and variable methods that do not provide a consistent assurance that the moisture within the channels and recessed areas described above is removed and thus that the remote and / or recessed areas are dry. Attempts to simply hang the device vertically so that wet channels are positioned such that water inside the channels will eventually run down and evaporate due to the effect of gravity have not yielded good results. This technique has been shown to be false by evidence that these channels do not consistently dry completely even after several days in this position.

[0012] Attempts to address these problems include attempts to rinse these channels with alcohol, on the premise that alcohol can accelerate drying and act as an auxiliary bacteriostatic agent (although medical devices are already disinfected or sterilized at this point). Data shows that this attempt does not clearly accelerate the drying time or drying effect and, in certain cases, may rather extend the time of the drying process. In addition to this, there is also concern that using alcohol may cause certain bacteria and pathogens that are otherwise inert or harmless to become established within the channels, and furthermore that these bacteria and pathogens may be transmissible to patients or users.

[0013] Other techniques include those that use air drying, but this technique is inherently difficult and time-consuming due to the channels that need to be dried being recessed and sometimes elongated, and is variable. Some of these channels are 4 to 6 feet in length and have a diameter of only a few millimeters or less. Drying techniques include suspending the device in a cabinet where air circulates using a motor-driven fan that blows compressed air into or through the channels to enhance drying or blows air into a small space. These techniques include a specific technique called "forced air drying" where air blown through a pipe system into a narrow area such as an endoscope channel by a motor-driven fan is filtered. Even these more aggressive and targeted techniques have variable results, at least partially due to the distance the air must travel to dry the channels, the possibility of changes in channel diameter that affect air velocity, and the surface tension of the water that is more effective than the air force in various ways and hinders timely water removal. In addition, narrow spaces inherently help trap or retain water, promote a moist environment, and inhibit evaporation. There are further challenges that go beyond these significant difficulties, including endoscopes and other devices with curved internal channels, in which case a Y-junction and connector where one or more channels come together and water can accumulate, and more variable surfaces such as areas adjacent to and / or outside of valves that interact with the channels are created.

Prior Art Documents

Patent Documents

[0014]

Patent Document 1

Patent Document 2

Summary of the Invention

Problems to be Solved by the Invention

[0015] Accordingly, it is considered desirable to provide an improved system and method for drying endoscopic instruments, such as endoscopes and other instruments having remote channels and lumens, after they have been cleaned 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 remove all fluids and moisture, including fluids present in crevices, scratches, Y-junctions, or other irregularities, from the internal lumens of endoscopic techniques. **Means for Solving the Problems**

[0016] Provided are devices and methods for drying endoscopic instruments, such as endoscopes, after they have been cleaned. These devices and methods are particularly useful for rapidly and consistently drying internal lumens or other spaces within endoscopic instruments. Also provided are devices, kits, and methods for both cleaning and drying endoscopic instruments and for performing inspections to confirm the success of cleaning and drying. The disclosed innovations address multiple limitations of current methods for cleaning and / or drying endoscopic lumens or channels and provide new and important functions that improve cleaning and drying performance.

[0017] The methods and devices disclosed herein can be used in combination with or incorporated into a variety of different reusable or disposable endoscopic instruments and devices, including endoscopes, trocars, cannulas, dilation devices, Foley catheters and other indwelling catheters, guidewires, central venous catheters, bipolar or monopolar electrosurgical devices or ultrasonic devices, arterial lines, drainage catheters, peripherally inserted central catheters, endotracheal tubes, feeding tubes, lung ventilators, ventilators, robotic surgical devices, and other devices that are implanted, inserted, and / or navigated within the body and that include internal lumens or other internal spaces. The dimensions of the drying devices disclosed herein are, of course, considered to be adjustable to the size of a particular instrument or device.

[0018] In one embodiment, a drying device for use in an endoscopic instrument includes an elongate member configured to advance through a lumen within the endoscopic instrument and a drying element coupled to at least a portion of the elongate member. The drying element includes a certain portion having an outer dimension (e.g., diameter, width, height, or other dimension) that is greater than the outer dimension of the elongate member.

[0019] In certain embodiments, the drying device is sterilized or disinfected such that the sterilized and / or disinfected device channel is not impaired by the drying process. Conversely, when this drying device is passed through an already sterilized or disinfected device channel, water and moisture are removed without changing or contaminating the state of the sterilized or disinfected device.

[0020] In certain embodiments, the drying device includes more than one drying member. For example, in one such embodiment, the drying device includes from 2 to 10 drying members, preferably from 2 to 6 drying members. The drying members can be coupled to each other to enhance the effectiveness of the device and provide a series of such drying members along the elongate element or separated by various distances.

[0021] The drying member can be a disk, fin, squeegee, or other protrusion that extends outwardly from the elongate member. In an embodiment, the drying member is shaped to create a consistent circumferential contact point with the inner wall of these channels when the elongate member is advanced through an endoscopic channel such as a biopsy channel or a suction channel.

[0022] In certain embodiments, the drying member preferably has a substantially annular, circumferential, cylindrical, or conical shape such that at least a portion of this element has a diameter approximately equal to or slightly larger than the diameter of the inner lumen. In an exemplary embodiment, the diameters of the proximal and distal end portions are from about 1 to about 1.5 times, preferably about 1.25 times, the diameter of the inner lumen. This avoids flexure of the proximal and distal end portions and thereby reduces buckling and the creation of a gap between the drying element and the inner wall of the lumen.

[0023] In certain embodiments, the elongate member of the drying device includes filaments, wires, tubes, shafts, or other elements having the function of advancing into long, curved, or other channels with internal channels that are recessed or internal and difficult to access. In an embodiment, this element is gripped at the end after being pulled through the internal channel and can then be pulled through the channel as part of the drying process. Similarly, this advancing element can be advanced by pushing the element from the other end. This element can include versions that can advance air through the device into a channel that includes a location removed from the typical effects of forced air drying within the channel, well inside the channel.

[0024] The drying member can include one or more substantially annular or cylindrical members spaced apart from each other down the elongate member. The cylindrical members are configured to maintain contact with the channel wall to remove any moisture that moves as the elongate element progresses through the channel. The elongate element can be advanced by being pushed in and pulled out or by other means including rocking back and forth, pattern-based advancement and withdrawal. The elongate element can be advanced through the scope by connection to any other means of moving the channel drying element through the channel to move, absorb, and / or remove water by automated or mechanized means or by direct contact with the surface area to be at least partially dried.

[0025] In an embodiment, the drying element of the present invention can be any shape or form that includes a squeegee, a disk, a fin, a cylinder, a series of absorbent strips, or other absorbent materials or substances including sponge, venturi or reverse venturi, oblong and round, ball or spherical drying elements and can move water and moisture through forward or backward movement.

[0026] In an embodiment, the drying member can include a series of one or more than one cylindrical squeegees designed to make wall contact with the inner wall of the channel to remove fluid and moisture from the channel. These cylindrical squeegees can be arranged in any manner effective for removing fluid and moisture from the channel. This arrangement can be an arrangement of two squeegee groups followed by three groups or vice versa, or other squeegee configurations, such as one squeegee group followed by two groups, two groups followed by four groups, three groups and four groups, four consecutive, five consecutive, or any other number and configuration of squeegees depending on the diameter, length, curvature of the channel, junction with other channels, and other factors that are effective for removing water and moisture.

[0027] In an embodiment, some of these squeegees can be of different heights to make the device widely adaptable for use in channels of different sizes. For example, the device can have a squeegee with a diameter from 5 mm to 5.2 mm, followed by a smaller squeegee with a diameter between 2 mm and 2.2 mm, and then another squeegee with a diameter from 3.8 mm to 4 mm to generate variable wall contact across different channel sizes. In an embodiment, the height and arrangement of the squeegees are not limited to this description, and these diameters, arrangements, squeegee thicknesses, and others can vary based on what is most effective for drying for a given channel drying application.

[0028] The spacing between the squeegee and any other element, including the drying element, can be any spacing that promotes rapid and predictable channel drying, including a spacing of 1 mm, 1.25 mm, 1.5 mm, 2 mm, a narrow spacing of 1.25 mm, and a subsequent 4 mm gap, followed by a spacing of 1.25 mm to 1.5 mm, or any other spacing that optimizes and promotes rapid and predictable channel drying, or a narrower, wider, or more variable other spacing. The spacing, diameter, alignment, and grouping of the drying elements can vary in embodiments based on the channel size, channel material, number of bends when navigating in each direction, number of junctions with other channels, material of the channel dryer if any exists, and other factors unique to a given channel drying application.

[0029] The thickness of the squeegee and fins can be any thickness that aids in channel drying, further dries, and in further embodiments aids in the positioning of the fins and squeegee to be cleaned. In embodiments, this thickness can include a thickness of the squeegee and fins between 0.2 mm and 0.5 mm, other variations having a thickness from 0.5 mm to 1.0 mm, a tapered thickness that improves the flexure and conformity of the element to the channel wall and at the same time supports around the advancing element and has a greater thickness at the base of the squeegee or fin and tapers as it approaches the channel wall to provide a predetermined rigidity and flexibility, including other different values.

[0030] The annular members are spaced apart from each other 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 annular member and the second annular member are spaced apart by a greater distance than the distance by which the second annular member and the third annular member are spaced apart from each other.

[0031] In one embodiment, it includes at least first and second annular member groups, each having a plurality of annular members. The annular members within each group can be spaced substantially equally from each other or can have different spacings. The first group is spaced from the second group by a distance greater than the spacing within each of the first and second groups.

[0032] Fins, disks, squeegees, or other annular members, or other drying members, can be at an angle to the channel walls that promote and enhance drying, which is vertical, or angled backward and between 1 and 89 degrees, or angled forward and between 1 and 89 degrees, or any other angle that promotes drying. In embodiments, these angles should not be limited to this description and should vary based on what is most effective for drying for a given channel drying application.

[0033] 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 can further include a swab member having a first end attached to the loop and a second end including a tail. The swab member can 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, and the tail can be of any length. The swab member can include one or more materials that can be braided or twisted, and the tail end of the swab member includes an unbraided or untwisted end composed of one or more of the materials that make up the swab member. Further, the swab member can include a foam material and / or a microfiber material.

[0034] In addition to this, the rod member can include one continuous polymer rod where its looped end has one thickness or diameter and its linear end has two thicknesses or diameters of the looped end of the rod. The two thicknesses or diameters of the polymer rod forming the linear end of the rod member can be melted or joined together, adhered to each other, or co-extruded.

[0035] In an embodiment, the drying device includes a centering element that keeps the drying element centered as it advances through the channel to be dried. This centering element prevents the drying element from losing contact with the wall of the channel being dried and enhances the drying effect. The centering element can be of any shape that keeps the device substantially centered within the lumen and prevents the above-described deflection, and a preferred embodiment is a cylindrical shape with a tapered distal end. When the device is pulled around the bends, corners, and junctions of the lumen, this type of inconsistency, which is a problem with existing brushes and pull-through cleaners, is generated, and 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 it is a brush, a pull-through cleaner, or any other device), and an adverse effect on the effectiveness of the drying method. By placing the centering element in front of, behind, or both in front of and behind the device, this problem is corrected, and in particular, a more consistent and effective drying is provided around the bends, corners, channel junctions, and other complex areas inside an endoscope, other endoscope instruments, or endoscope devices.

[0036] In a preferred embodiment, the centering element is between 50 percent and 90 percent of the diameter of the lumen to be cleaned, and a more preferred embodiment has a diameter or height between 70 percent and 85 percent of the diameter of the lumen to be cleaned.

[0037] In some embodiments, the centering element can include a series of shaped elements that project from an elongate member or a navigation member. This series of shaped elements can include, for example, struts, spikes, or other protrusions that extend radially outward from the elongate member and are sized to substantially center the elongate member and / or the drying / cleaning element within the internal channel of the endoscope device.

[0038] In an embodiment, the elongate member can be advanced from the proximal end of the internal lumen of an endoscopic instrument, such as a biopsy channel on an endoscope, to the distal end of the biopsy channel and then withdrawn from the biopsy channel and connected to a drying element, including an attachable push-and-pull element such as a navigation element. In certain embodiments, the drying device is removably attachable to the distal end portion of the advancing or navigation element. In other embodiments, the drying device is permanently attached to the navigation element. These embodiments enable the drying element to be translated from the distal end of the endoscopic lumen to its proximal end or vice versa.

[0039] In certain embodiments, the drying device includes a programmable motor coupled to the elongate member and configured to translate the device through the lumen of the endoscopic instrument. Preferably, the programmable motor is configured to withdraw the elongate member through the lumen a specified distance over a specified duration.

[0040] In another aspect, a method of drying one or more lumens within an endoscopic instrument includes providing a drying device including an elongate member and at least one drying member coupled to a portion of the elongate member, and advancing at least a portion of the elongate member through the lumen within the endoscopic instrument such that the drying member substantially maintains contact with the wall of the lumen within the endoscopic instrument. In certain embodiments, the drying device is sterilized or disinfected, and thus the sterilized and / or disinfected device channel is not impaired by the drying process.

[0041] In an embodiment, the method further includes centering the drying member within the lumen when advancing the drying member through the lumen. Preferably, the centering element is smaller than the diameter of the lumen through which the device is advanced, but is significantly large enough to prevent misalignment and deflection of the navigation element to one side or the other of the lumen when the navigation element, including when the drying device is withdrawn or pushed through the curved portions, corners, and junctions (including Y-junctions) of various lumens.

[0042] The method can further include introducing a guide element through a first opening in the lumen of the instrument and advancing an elongate drying device through a second opening in the lumen such that at least a portion of the elongate drying device engages the guide element. The guide element engages and couples with the drying device such that the drying device can be drawn towards the first opening of the lumen using the guide element.

[0043] 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 a suction channel within the endoscope. In these embodiments, the method further includes introducing the guide element through the first lumen and past the junction and into the second lumen, and advancing the elongate drying device through the second lumen such that the elongate drying device engages the guide element. Thereafter, the guide element can be used to draw the drying device back through the junction and through the first lumen. This ensures that the drying device dries the biopsy channel without bending and passing proximally past the Y-junction and further into the suction channel.

[0044] In other embodiments, the endoscope lumen includes a twist or bend having a relatively small radius of curvature that is otherwise considered difficult to advance a drying element therethrough. In these embodiments, the guide element is introduced and advanced through the lumen on one side of the twist. The drying device is advanced or retracted through the lumen on the other side of the twist until it engages the guide element. The guide element is then withdrawn to pull the drying device through the twist.

[0045] The guiding element can include a tubular sheath or similar device having a distal end portion configured to engage the distal end portion of the cleaning element. In some embodiments, the tubular sheath is removably coupled to the cleaning element. In other embodiments, the tubular sheath can have an inner diameter larger than the outer diameter of the proximal end portion of the elongate drying element and can be further configured to distort or otherwise direct the drying element past a junction or other intricate area within the lumen.

[0046] 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 within 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 has an outer diameter equal to or greater than the outer diameter of the elongate member. The kit further includes a cleaning device having a second elongate member configured to advance through a lumen within the endoscopic instrument and at least one cleaning member coupled to a portion of the elongate member. The cleaning member can be used to clean the lumen at an earlier stage of the cleaning process and, in embodiments, to disinfect or sterilize the device.

[0047] In one embodiment, the drying device is one of the embodiments described above, and the cleaning member includes distal and proximal end portions and a central portion between the distal and proximal end portions, the central portion being shaped to generate a pressure gradient along the central portion from the distal end portion to the proximal end portion. The variable pressure central portion of the cleaning device is designed to generate a variable pressure between two circumferential elements and the wall of the channel being cleaned. That is, when the cleaning member advances inside the channel and the viewing mirror and its channel are submerged in the cleaning fluid (as required by the viewing mirror manufacturer), the variable pressure design between the two circumferential elements generates a Venturi effect between the cleaning element and the wall of the endoscope channel when the cleaning element is moved through the lumen. As a result, when the cleaning fluid flows across the variable pressure zone, this affects the fluid flow as the fluid moves across from the high pressure zone to the low pressure zone and back to another high pressure zone between the two cylindrical elements. This induces the cleaning fluid at the channel wall at high speed and force, thereby removing more biological material and other debris than conventional devices. This same pressure waveform effect can be generated using the drying device, in which case air is pressurized and flows in a manner similar to liquid fluid flow.

[0048] In another embodiment, the cleaning device can include any of the combinations of elements described above with respect to the drying device.

[0049] In another aspect, a kit for cleaning and drying an endoscope instrument includes a drying / cleaning device having an elongate member configured to advance through a lumen within the endoscope instrument and at least one cleaning / drying member coupled to a portion of a second elongate member. In this aspect, the drying / cleaning device is configured to clean and dry the internal lumen while being passed therethrough. In an embodiment, this version can be made particularly useful for performing cleaning and drying after using liquid chemical sterilants and chemical disinfectants, or can be used to clean using one aspect of the kit and dry using an individual aspect (preferably, sterilized or disinfected).

[0050] In a preferred embodiment, the present invention is configured to be used in combination with an endoscope. The forward or navigation element is a polymer filament, wire, or tube. The material for the forward element can be any suitable one for the intended use that is considered to be, in embodiments, polypropylene, PET, nylon, PEEK, PTFE, ETFE, polyurethane, high or low density polyethylene, or other suitable polymer materials. The forward or navigation element can also be a combination of materials including a metal wire (including stainless steel, nitinol, or other materials), or a polymer reinforced by a wire, a wire covered with a polymer, or a combination thereof.

[0051] In one embodiment, the drying element is injection molded onto the forward element or connected or glued to the forward element. The injection molded drying element is of any durometer hardness that aids in drying the channel, but in a preferred embodiment, the durometer hardness of the material is between 35 and 75 Shore A. In embodiments, the drying element can be manufactured from any elastomeric material or any elastic material including Pebax, polyurethane, Santoprene, silicone, high or low density polyethylene, EVA, and other elastomeric materials. In embodiments, the drying element can also be a combination of materials including a combination of hard and soft materials having various elasticities.

[0052] In embodiments, the drying portion version of the present invention can include materials that can absorb water, such as sponges, absorbent cloth materials, or other materials that can absorb and retain moisture and water. These materials can be attached to the forward element as single or various lengths of material strips, overlapping materials, round balls, or any other shape that aids in removing water and moisture from the channel when passing the forward element through the channel. These absorbent materials can be placed at the end or beginning of the drying element or interspersed between other drying elements such as squeegees or fins.

[0053] The present invention can include a coating that aids in hydrophilic or hydrophobicity and aids in navigation by varying the friction level. The present invention can have a lumen that allows air to blow through the present invention to force air to be delivered closely to the channel wall or to a depth in its immediate vicinity inside the channel.

[0054] In other embodiments, the cleaning / drying device can have one or more absorbent sponges disposed between its front or end or between one or more of the cylindrical elements to absorb biological matter and debris. The absorbent sponge can be of a single cell configuration or have multiple sponges with different cell configurations in providing wiping, absorption, peeling, diffusion, or a combination of these attributes of the cleaning fluid. The absorbent sponge can include any material that absorbs biological matter, fluid, or other debris such as polymers, foams, sponges, bamboo, hemp fibers, microfibers, polyurethane, or polyvinyl alcohol. In one embodiment, the cleaning member includes a spongy material such as cellulose, dry cellulose, natural cellulose, and / or compressed cellulose. In an exemplary embodiment, the material includes a mixture of cellulose and compressed cellulose that allows the sponge to expand when hydrated. Preferably, the material is selected such that in a preferred embodiment, the sponge has the function of expanding at least to the inner surface of the lumen while maintaining sufficient absorbency to absorb a volume of substance or fluid at least equal to the volume of the segment of the lumen occupied by the sponge.

[0055] In an embodiment, the sponge is soft and non-traumatic when submerged in a fluid, expands to a size sufficient to remove debris from at least the channels to be cleaned (and / or remove moisture and fluid from the channels), and in a preferred embodiment is larger than the channels to be cleaned. The sponge can be of any shape and size that aids in conforming to and cleaning the channels of the viewing lens, for example, cylindrical, helical, conical, triangular, square, or any shape including but not limited to combinations thereof, and can be further disinfected or sterilized.

[0056] In other embodiments, the devices disclosed herein can be used to dry indwelling devices. In these embodiments, the device can further include a sheath or similar structure that covers the drying element and / or the elongate element to avoid disturbing any biofilm accumulated therein and any biological material while translating through the lumen of the instrument. The system can also include a measurement device, such as a marker, on the elongate element or a separate element to confirm the positioning of the device within the lumen of the catheter. The polymer forming the drying element can expand with the sheath withdrawn. Alternatively, electro-responsive polymers can be used to change and expand the shape by applying energy, and these polymers can be expanded to contact or at least partially contact the wall of the catheter.

[0057] The device can include a coating that is hydrophobic. In yet another embodiment, the device has superhydrophobic and / or oleophobic properties. In yet another embodiment, the device has anti-infection and hydrophobic properties. In yet another embodiment, the device has anti-infection and superhydrophobic properties. In yet another exemplary embodiment, an anti-inflammatory coating is incorporated within the device. In other embodiments, the anti-inflammatory coating can include or be hydrophilic.

[0058] It should be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive. Additional features of this description are listed in part in the following description or can be learned by practice of this description.

[0059] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate some embodiments of this description and together with the description serve to explain the principles of this description.

Brief Description of the Drawings

[0060]

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Figure 9

Modes for Carrying Out the Invention

[0061] This description and the accompanying drawings illustrate a plurality of exemplary embodiments and should not be construed as limiting. The claims define the scope of this description, including equivalents. Various mechanical, compositional, structural, and operational changes can be made without departing from the scope of this description and the claims including equivalents. In some instances, well-known structures and techniques are not shown or described in detail so as not to obscure the description. Similar numbers in two or more figures represent the same or similar elements. Further, elements and related aspects described in detail with reference to one embodiment can be included in other embodiments as long as they can be implemented in those other embodiments without being specifically shown or described. For example, even if an element is described in detail with respect to one embodiment and not described with respect to a second embodiment, that element can be claimed as being included in the second embodiment. Further, the depictions herein are for illustrative purposes only and do not necessarily reflect the actual shape, size, or dimensions of the system or the exemplary components being illustrated.

[0062] Note that, as used in this specification and the appended claims, the singular forms “a,” “an,” and “the,” and any singular use of any word, include plural referents unless expressly and unambiguously limited to one referent. The term “including” as used herein and its grammatical variations are intended to be non-limiting such that the recitation of items does not exclude other similar items that can be substituted for or added to those recited items.

[0063] The following description is primarily related to endoscopes and devices for drying them, but it should be understood that the features of the described system can be readily adapted for use in various reusable or disposable endoscopic instruments and endoscopic devices, including internal lumens and other internal spaces such as endoscopes, trocars, cannulas, dilation devices, Foley catheters, guidewires, central venous catheters, bipolar or monopolar electrosurgical devices or ultrasonic devices, lung ventilation devices, ventilators, CPAP and other positive pressure airway devices, robotic surgical instruments and remote surgical instruments, arterial lines, drainage catheters, peripherally inserted central catheters, endotracheal tubes, feeding tubes, and other devices that are placed, inserted, and / or navigated within the body.

[0064] As used herein, the term "endoscope" refers to any scope used for or in connection with medical applications, including the body (human or otherwise), and includes, for example, laparoscopes, arthroscopes, colonoscopes, gastroscopes, duodenoscopes, endoscopic ultrasounds, bronchoscopes, enteroscopes, cystoscopes, laparoscopes, laryngoscopes, sigmoidoscopes, thoracoscopes, cardiac scopes, and vein strippers that use scopes, regardless of whether they are for robotic, non-robotic, or non-medical applications.

[0065] When remote visualization within a patient's body is performed, various scopes are used. The scope used depends on the degree of need for the physician to navigate within the body, the type of surgical instrument used in the procedure, and the appropriate level of invasiveness for the type of procedure. For example, visualization of the inside of the gastrointestinal tract may involve the use of flexible gastroscopes and colonoscopes, as well as endoscopes in the form of special duodenoscopes that can have lengths of several feet and diameters greater than 1 centimeter. These scopes can be rotated and articulated or steered by the physician as the scope is navigated through the patient. Many of these scopes include one or more working channels for passing and supporting instruments, fluid channels and irrigation channels for perfusing tissue to clean the scope, gas injection channels for injecting gas to improve navigation and visualization, and one or more light guides for illuminating the field of view of the scope.

[0066] For medical use, endoscopes that are smaller, less flexible or rigid, or those that combine flexibility and rigidity are also used. For example, when examining joints and performing arthroscopic surgery, such as shoulder or knee surgery, smaller, thinner, and considerably shorter endoscopes are used. When a surgeon repairs a torn meniscus inside the knee using arthroscopic surgery, usually a shorter and more rigid endoscope is inserted through a small incision on one side of the knee to visualize the damage, while at the same time an instrument is passed through an incision on the opposite side of the knee. These instruments can irrigate the endoscope inside the knee to maintain visualization and manipulate the tissue to complete the repair.

[0067] Other endoscopes may be used in diagnostic and procedural low-invasive endoscopic procedures, including, by way of example, endoscopes (bronchoscopes) for examining and treating conditions in the lungs, endoscopes (enteroscopes) for the mouth, endoscopes (cystoscopes) for the urethra, endoscopes (laparoscopes) for the abdomen and peritoneal cavity, endoscopes (laryngoscopes) for the nose and paranasal sinuses, endoscopes (sigmoidoscopes) for the anus, and endoscopes (gastroscopes, duodenoscopes, colonoscopes) for other aspects of the gastrointestinal tract, endoscopes (thoracoscopes) for the chest and thoracic cavity, but are not limited thereto. Additionally, robotic medical devices also rely on endoscopes for remote visualization of the site where they are performing evaluations and procedures.

[0068] These and other endoscopes can be inserted through natural orifices (such as the mouth, paranasal sinuses, ear, urethra, anus, and vagina), and further through incisions and port-based openings at the patient's skin, cavity, skull, joints, or other medically designated entry points. Diagnostic use examples of endoscopic examination by visualization using these medical endoscopes can include scrutinizing the symptoms of diseases such as those of the digestive system (e.g., nausea, vomiting, abdominal pain, gastrointestinal bleeding), can support a diagnosis (e.g., by performing biopsies regarding anemia, bleeding, inflammation, and cancer), or include surgical procedures for diseases (removal of a ruptured appendix or cauterization of gastric bleeding).

[0069] Referring now to FIG. 1, a representative endoscope 10 includes a proximal handle 12 adapted for operation by a surgeon or clinician and coupled to an elongate shaft 14 adapted for insertion into a patient's body cavity by endoscopic or percutaneous penetration. The endoscope 10 further includes a fluid delivery system 16 coupled to the handle 12 through a universal cord 15. The fluid delivery system 16 includes several different tubes coupled to an internal lumen within the shaft 14 for delivery and aspiration of fluids such as water and air, and other features that a clinician may desire to move fluids, blood, debris, and particulate matter from the field of view. This elimination provides a clearer view of deeper tissues or substances for evaluation and treatment. In this representative embodiment, the fluid delivery system 16 includes a water injection connector 18, a water cylinder connector 20, a suction connector 22, and an air pipe 24. The water injection connector 18 is coupled to an internal water injection lumen 28 that extends through the handle 12 and the elongate shaft 14 to the distal end of the endoscope 10. Similarly, each of the water cylinder connector 20, the suction connector 22, and the air pipe 24 is connected to internal lumens 30, 32, 34 that pass through the shaft 14 to the distal end of the endoscope 10.

[0070] The proximal handle 12 can include various controllers for a surgeon or clinician to operate the fluid delivery system 16. In this representative embodiment, the handle 12 includes a suction valve 34, an air / water valve 36, and a biopsy valve 38 for removing tissue samples from a patient. The suction channel 34 originates from the suction connector 22, forms a relatively sharp kink or bend 22A, and extends into the handle 12 through the universal cord 15. Next, the suction channel 34 extends through the shaft 14 to the distal end of the endoscope 10. The suction channel 34 forms an internal Y-junction 38B with a channel 38C that extends into the biopsy valve 38 at the location where it passes through the biopsy valve 38. This Y-junction 38b presents challenges when cleaning and / or drying the suction channel 34 using conventional devices, as will be discussed in more detail below.

[0071] In certain embodiments, the handle 12 further includes an eyepiece (not shown) coupled to an image capture device (not shown) such as a lens and a light transmission system. Similarly, as used herein, the term "image capture device" does not necessarily refer only to a device having only a lens or other light guiding structure. In contrast to such devices, for example, an image capture device can be any device that can capture and transmit an image and can include (i) a relay lens between the objective lens at the distal end of the endoscope 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 merely a chip for sensing light and generating a communication electrical signal corresponding to the sensed light or can be other technology for transmitting an image. The image capture device can have an observation end where light is captured. Generally, the image capture device can be any device capable of observing an object, capturing an image, and / or capturing an image.

[0072] In some embodiments, the endoscope 10 includes some form of positioning assembly (e.g., a hand controller) attached to the proximal end of the shaft to enable an operator to manipulate the endoscope. In other embodiments, the endoscope is part of a robotic element that provides steerability of the endoscope to a desired point for examining and focusing the endoscope and enables positioning of the endoscope.

[0073] As shown in FIG. 2, the endoscope 10 can further include a camera lens 62 for providing a view of the surgical site within the patient's body, a scope washer 32, and a light source 60, and a biopsy channel 50 for passing instruments therethrough. The biopsy channel 50 enables passage of instruments along the shaft 14 of the endoscope 10 for removing tissue. The biopsy channel 50 can act as an operating channel for other instruments to pass through the endoscope 10 for evaluation and procedures of tissue and other substances. Such instruments can include cannulas, catheters, stents and stent delivery systems, papillotomes, wires, other imaging devices including small scopes, baskets, snares, and other devices for use in combination with the scope within the lumen. Alternatively, the endoscope 10 can include individual operating channels for these instruments.

[0074] Exemplary drying devices are described hereinbelow. The cleaning and drying device includes an elongate shaft and a drying member disposed on a portion of the shaft. The drying member can be removably attached to or permanently fixed to the shaft. The shaft can include any suitable material that provides sufficient rigidity to advance it through the lumen of the endoscope. The elongate shaft has an outer diameter sized to fit within and translate through the internal lumen of the endoscope 10. In this exemplary embodiment, the shaft will have an outer diameter in the range of from about 0.5 mm to about 5 mm, preferably from about 1 mm to 4 mm.

[0075] The drying member can include one or more substantially cylindrical members spaced apart from each other along the advancing member. The cylindrical member is configured to maintain contact with the channel wall to allow any moisture to move and be removed as the advancing element travels through the channel. The advancing element can be advanced by being pushed in, pulled out, or by other means including back-and-forth rocking, pattern-based advancement and withdrawal. The advancing element can travel through the viewing lens by connection to any other means of moving the channel drying element through the channel to move, absorb, and / or remove water through at least partial direct contact with the connection to an automated or mechanized technique or the surface area to be dried.

[0076] In certain embodiments, the drying device described herein is sterilized or disinfected, and for this purpose the sterilized and / or disinfected device channels are not impaired by the drying process. Instead, when passing this drying device through an already sterilized or disinfected device channel, water and moisture are removed without changing or contaminating the state of the sterilized or disinfected device in the channel.

[0077] In certain embodiments, the device includes a withdrawal cable configured to withdraw or advance the elongate shaft within the internal lumen of the endoscope 10. Further, the device can include an energy source and a motor for advancing and / or withdrawing the elongate shaft. Of course, it will be recognized that the elongate shaft can be manually translated through the internal lumen by a proximal handle or a suitable actuator (i.e., not a motor).

[0078] Next, the drying device 200 according to a certain embodiment will be described below with reference to FIG. 3. The drying device 200 includes an advancing element 202 and one or more drying elements 204 attached thereto. The advancing element 202 can be advanced from the proximal end to the distal end of any internal lumen within the endoscope (or vice versa). For example, in one embodiment, the advancing element 202 is advanced from the biopsy channel of the endoscope to the distal end of the biopsy channel to exit therefrom and connect to the cleaning and / or drying element. The advancing element 202 exits the biopsy channel of the endoscope and advances to the distal end of the biopsy channel (or the suction channel if applicable) to connect to the drying element or, alternatively, can be advanced through the channel from the proximal end to the distal end of the biopsy channel (or the suction channel) and then withdrawn. This push-in and / or pull-out advancing element can be attachable to the drying element and, in embodiments, separable, and in other embodiments, can be permanently attached.

[0079] In other embodiments, the advancing element 202 and the drying element 204 are adhered to each other and advanced or retracted together through one or more lumens. The advancing element 202 and the drying element 204 can be manufactured as one integral device or manufactured separately and attached to each other prior to use.

[0080] The drying element 204 can conform substantially to the wall of the internal lumen, thereby creating a consistent circumferential contact with the inner wall of an endoscopic channel, such as a biopsy channel or a suction channel, and can include any shape suitable for removing fluid and moisture from the channel. In certain embodiments, the drying element 204 preferably has a substantially annular, circumferential, cylindrical, or conical shape and has a diameter approximately equal to or slightly larger than the diameter of the internal lumen. In an exemplary embodiment, the maximum diameter of the drying element 204 is from about 1 to about 1.5 times the diameter of the internal lumen, preferably from about 1 to about 1.23 times this diameter. For example, when the diameter of the internal lumen is about 5 mm, the maximum diameter portion of the element 204 can be from about 4.2 mm to 5.5 mm, preferably about 5 mm. This additional size allows the element 204 to deform slightly as it passes through the lumen, ensuring that these elements remain in contact with the lumen.

[0081] The drying element 204 can be arranged in any manner effective for removing fluid and moisture from the channel. This arrangement can be an arrangement of 2 groups of squeegees followed by 3 groups or vice versa, or other squeegee configurations, such as 1 group of squeegees followed by 2 groups, 2 groups followed by 4 groups, 3 groups and 4 groups, 4 in a row, 5 in a row, or any other number and configuration of squeegees effective for removing water and moisture and depending on the diameter, length, curvature, junctions with other channels, and other factors of the channel.

[0082] In an embodiment, some of these drying elements 204 can be of various heights to make the device 200 widely adaptable for use in channels of various sizes. For example, the device can have drying elements 204 with a diameter ranging from 5 mm to 5.2 mm to create varying wall contact across various channel sizes, followed by smaller drying elements 204 with a diameter between 2 mm and 2.2 mm, and further followed by another drying element 204 with a diameter ranging from 3.8 mm to 4 mm. In an embodiment, the height and arrangement of the drying elements 204 are not limited to this description, and these diameters, arrangements, thicknesses of the drying elements 204, and others can vary based on what is most effective for drying for a given channel drying application.

[0083] The spacing between the drying elements 204 can include spacings of 1 mm, 1.25 mm, 1.5 mm, a spacing of 2 mm, a narrow spacing of 1.25 mm, and a subsequent gap of 4 mm, and further followed by a spacing between 1.25 mm and 1.5 mm, or any spacing that promotes rapid and predictable channel drying, or other spacings that narrow, widen, or are more variable to optimize and promote rapid and predictable channel drying. The spacing, diameter, alignment, and grouping of the drying elements can, in an embodiment, vary based on the channel size, channel material, number of bends when navigating in either direction, number of junctions with other channels, material of the channel dryer if any is present, and other factors unique to a given channel drying application.

[0084] The thickness of the drying element 204 is any thickness that aids in channel drying and positioning of the element 204 for drying. In an embodiment, this thickness includes a thickness of the drying element between 0.2 mm and 0.5 mm, other variations with a thickness from 0.5 mm to 1.0 mm, and other different values including a tapered thickness where the thickness is large at the base of the drying element and tapers as it approaches the channel wall to improve the flexure and conformity of the element to the channel wall while at the same time providing support around the advancing element and a predetermined rigidity and flexibility.

[0085] In an embodiment, the device 200 includes a centering element (not shown) that keeps the drying element centered as it advances through the channel to be dried. This centering element prevents the drying element from losing contact with the wall of the channel being cleaned and improves the drying effect. When advancing the drying element, the centering element can have any shape that keeps the drying element centered relative to the channel so that the drying element does not flatten against the wall due to any lateral movement required to navigate through the channel, especially around the bends, and thereby lose contact with the channel wall being dried. In an exemplary embodiment, the centering element is between 50% and 95% of the diameter of the channel being dried or cleaned. The centering element can be placed at any location on the advancing element or on the drying element, and can include multiple centering elements to enhance and maintain the performance of drying and cleaning.

[0086] In some embodiments, the centering element (424) can include a series of shaped elements that project from an elongate member or navigation member. This series of shaped elements can include, for example, struts, spikes, or other protrusions that extend radially outward from the elongate member and are sized to substantially center the elongate member and / or the drying / cleaning element within the internal channel of the endoscopic device.

[0087] The centering element serves to center the advancing element 202 and the drying device as the device is withdrawn or pushed through the lumen around the swivel section and passes through other complex areas including corners and junctions of multiple lumens and internal channels being cleaned within the scope or other instruments. In an embodiment, the centering element can be smaller than the diameter of the lumen through which the device is advanced, but is large enough to prevent misalignment and deflection of the advancing element 202 to one side or the other of the lumen when the advancing element 202 passes through, including when the cleaning and / or drying device is pulled or pushed around the bends, corners, and junctions (including Y-junctions) of various lumens.

[0088] The centering element can be of any shape that keeps the device approximately centered and prevents this deflection, and a preferred embodiment is a cylindrical shape with a tapered distal end. When the cleaner is withdrawn around the bends, corners, and junctions of the lumen, if this type of inconsistency, which is a problem with existing brushes and pull-through cleaners, occurs, the brush and other elements are drawn to one side of the lumen, and as a result, the contact between the lumen wall and the drying element (whether it is a brush, a pull-through cleaner, or any other device) is minimized, detrimentally modified or lost, and an adverse effect on the effectiveness of the drying method is brought about. By disposing the centering element in front of or behind or both of the device, this problem is corrected, and in particular, a more consistent and effective drying is brought about around the bends, corners, channel junctions, and other complex areas inside an endoscope, other endoscope instruments, or endoscope devices.

[0089] In a preferred embodiment, the centering element is between 50 percent and 90 percent of the diameter of the lumen being cleaned, and a more preferred embodiment has a diameter or height between 70 percent and 85 percent of the diameter of the lumen being cleaned. The centering element can be of any shape that maintains the centering of these elements when the cleaning and / or drying elements are navigated through the channel. In embodiments, this shape includes a cylindrical shape, a conical shape, a spherical shape, and the centering element can be disposed at the distal region, at the distal and proximal ends, between the drying members, or at the proximal end of the device, particularly suitable to help center the drying element when the drying element navigates around the bends of the lumen, when it navigates across a Y-junction, and when it navigates in other configurations.

[0090] The material for the advancing element 202 can be any material that is sufficient to pass through the channel being cleaned and that can manage the pulling force associated with advancing the cleaning and / or drying element 202 through the cleaned and dried channel. This material can include all metal and polymer-based materials, including stainless steel wire, nitinol, and other metals. Further, this material can be in the form of a monofilament, an extruded tube, a braid, or any other form sufficient to facilitate advancing the cleaning and / or drying element 204 through the cleaned and dried channel, including all polymer-based materials. In a preferred embodiment, the advancing element is a monofilament comprising nylon, polyamide, polyurethane, or other polymeric material and having a diameter of at least 1 mm. The advancing element 202 can include at one end a gripping element (not shown) that facilitates gripping and passing it. In an embodiment, this gripping element is larger than the entry point into the biopsy channel to prevent over-advancing the advancing element 202 into the biopsy channel and losing the gripping force on the advancing element 202.

[0091] In certain embodiments, the advancing element 202 can be attached to the drying element 204 by a permanent attachment by means of molding, overmolding, two-shot molding, gluing, or other means for creating an attachment that fixes or attaches these two elements for use between the advancing element and the drying element. Alternatively, the advancing element 202 can be individually attachable and, in certain embodiments, attachable and detachable, such that the advancing element 202 can be attached at one end of the channel and removed from the channel at the other end and then attached to the drying element 204. The attachment means can be any method suitable for the intended use and can include, by way of example, a coupling element, a compression fit, a sliding and locking mechanism, a surface fastener mechanism, an insertion and twisting mechanism, or a deformation and alternative combination suitable for the diameter and shape of the navigation device and the cleaning and / or drying device.

[0092] In an embodiment, the drying device 200 can include one or more absorbent sponges disposed in front of or at an end of the drying element 204 or between one or more of these drying elements. The absorbent sponge can be of a single cell configuration or have multiple sponges with different cell configurations when providing wiping, absorption, peeling, diffusion, or a combination of these attributes of the cleaning fluid. The absorbent sponge can include any material that absorbs biological substances, fluids, or other debris, such as polymers, foams, sponges, bamboo, hemp fibers, microfibers, polyurethane, or polyvinyl alcohol. In an embodiment, the sponge is soft and non-traumatic when immersed in a fluid and expands to a size at least that of the size of the dried channel, and in a preferred embodiment, larger than the dried channel. The sponge can be of any shape that fits and aids in drying the viewing mirror channel, such as, but not limited to, cylindrical, helical, conical, triangular, square, or any combination thereof. In an exemplary embodiment, the sponge will have a pore size between about 200 PPC and 1500 PPC, preferably between about 200 PPC and about 600 PPC.

[0093] Next, referring to FIG. 4, the cleaning device 200 can include brushes 210 of various designs that contact a portion of the channel wall in addition to other aspects of the drying element 200, such as tapered nylon brushes. In one embodiment, the brush 210 is positioned at the opposite end of the drying element 204 of the advancing element 202. This allows the user to clean, for example, the lumen or channel of the endoscope using the brush 210 and then dry the channel using the drying element 204. The brush can be sized to a length that is in a ratio of 1.0 times to 1.4 times the diameter of the channel being cleaned. In an embodiment, the brush is preferably made of a non-abrasive polymer such as polyurethane having a thickness and durometer hardness designed to limit trauma and damage to the channel wall while maintaining sufficient stiffness to remove contaminants 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 advancing element and in an embodiment can be part of an individual shorter navigation element designed to extend only a limited distance into the biopsy channel. This shorter version can be any length suitable for cleaning the initial entry point into the biopsy channel, but in a preferred embodiment the length is between 4.5 cm and 15 cm. Whether this brush attachment element is part of the cleaning / drying device or an individual shorter version, nylon wire bristles or other bristles can be utilized if arranged in a pattern that is effective for cleaning and minimizes trauma to the viewing channel. The gripping element of the brush can have a larger shape at one end or in the center of the element to facilitate introduction into the biopsy channel.

[0094] Next, referring to FIG. 5, another embodiment 300 of the drying device includes an advancing element 302 and one or more drying elements 304. The advancing element 302 can be advanced from the proximal end to the distal end of any internal lumen associated with the endoscope (or vice versa). In some embodiments, the advancing element 302 and the drying element 304 are adhered to each other and advanced or retracted together through one or more lumens. The advancing element 302 and the drying element 304 can be manufactured as one integral device or manufactured separately and attached to each other before use.

[0095] The drying element 304 substantially conforms to the wall of the internal lumen, thereby generating a consistent circumferential contact with the inner wall of the endoscope channel, such as a biopsy channel or a suction channel, and can include any shape suitable for removing fluid and moisture from the channel. In certain embodiments, the drying element 304 preferably has a substantially annular shape and a diameter approximately equal to or slightly larger than the diameter of the internal lumen.

[0096] The spacing between the drying elements 304 can include a spacing of 1 mm, 1.25 mm, 1.5 mm, 2 mm, a narrow spacing of 1.25 mm, and a subsequent gap of 4 mm, followed by a spacing of 1.25 mm to 1.5 mm, or any spacing that promotes rapid and predictable channel drying, or other spacings that narrow, widen, or are more variable to optimize and promote rapid and predictable channel drying. In one embodiment, the drying device 300 includes a first group of three drying elements 204 spaced apart from each other by a substantially equal distance, and a group of two drying elements 204 also spaced apart from each other by a substantially equal distance. The first group and the second group of drying elements 204 can be spaced apart from each other by the same distance as the individual elements or a longer distance (as shown in FIG. 5).

[0097] The drying element 300 can be used to substantially clean a lumen channel having an inner diameter of from about 2.8 mm to about 5.0 mm, from about 1.4 mm to about 2.6 mm, or from about 1.0 mm to about 1.2 mm.

[0098] In another embodiment, the drying device can include a rod-shaped or filamentous member having at least one end that terminates in a loop and a swab member attached thereto. The swab member can have a first end attached to the loop and a second end that includes a tail like a kite tail, and can have first and second ends that can be of any length. The swab member can include one or more materials that can be braided or twisted, and the tail end of the swab member includes an unbraided or untwisted end composed of one or more materials that make up the swab member. Further, the swab member can include a foam material and / or a microfiber material.

[0099] The rod member of the cleaning device can include a polymer having a first end that is a straight end and a second end that is a looped end. Further, the rod member can include one continuous polymer rod, the looped end of which includes one thickness or diameter and the straight end of which includes two thicknesses or diameters of the looped end of the rod. The two thicknesses or diameters of the polymer rod that form the straight end of the rod member can be melted or joined together, adhered to each other, or co-extruded. A more complete description of a suitable kite tail-shaped drying member can be found in U.S. Patent Publication No. 2014 / 0250614, the entire disclosure of which is incorporated herein by reference for all purposes.

[0100] Next, referring to FIGS. 6 and 7, another embodiment 400 of the drying device includes a manual pump 402 coupled to an air nozzle 404 for delivering air into the endoscope channel, and an air induction valve 406 for receiving air into the manual pump 402. The air nozzle 404 is preferably sized to fit into one of the valves of the endoscope device, such as an air / wash valve. In an embodiment, the device 400 can include one or more separable accessories or guide elements that will be inserted into the end of the channel to create a seal that aids in forcing air into the channel for drying. The device 400 allows the operator to quickly rinse the endoscope channel with air without the need to use a motor-driven fan or a central air line to force air into the channel.

[0101] The device 400 can further include a filter 408, such as a Hepa filter, for filtering the air flowing into the pump 402. In one embodiment, the filter 408 is positioned adjacent to the air induction valve 406 (FIG. 6). In another embodiment, the filter 408 is positioned within the air nozzle 404 (FIG. 7).

[0102] The drying device 400 allows for rapid and inexpensive delivery of air for flushing the channel, which is advantageous for smaller channels and further advantageous for accelerating the drying process for the drying device described above. The device 400 can be sterilized or disinfected or can include a sterile sheath or cover for gripping the pump 402. The pump 402 can be reusable or single-use and can be subjected to sterilization, including by gamma, ETO, electron beam, and other sterilization modalities.

[0103] Materials for the manual air pump and related components can include one or more elastic and elastomeric materials. As an alternative embodiment, a high-speed air pump can use a syringe or manual pump to push air into the channels to be dried, or access air from another source such as a built-in supply source within the surgical unit, and have a connector for directing this air through a heap filter and then through a nozzle into the sight glass channel. In an embodiment, this connector can have a single air supply source at one end and a branch for splitting the air between a plurality of channels to be dried. In an embodiment, this connector can include a valve for preventing backflow when the resistance to air flow is different between two adjacent channels and between these channels and a common supply source of forced and / or filtered air, and further preventing air for one channel from crossing over into an adjacent channel.

[0104] As an alternative to sterilizing the manual air pump, the technological innovation of the present invention includes a sterile sheath or cover and can ensure that the manual air pump for delivering forced air into the channels is inside the sterile cover.

[0105] The devices described above can be made into a kit with one or more related elements including, but not limited to, individual channel cleaners, channel cleaning verification tests (such as ATP tests), sponges for cleaning, sight glass carriers, enzymatic cleaning, detergents, drying sponges or other manual drying elements, channel drying verification tests, and other related products. The kit can include a Tyvek or other bag or container that can be sealed to keep the dried medical device in a dry state and maintain a disinfected or sterilized state. This bag or container can include a material attached inside the bag or to a small pouch or other means to absorb the ambient humidity inside the bag or container. This bag or container and the other elements of the kit can be sterile, disinfected, or non-sterile.

[0106] A kit for use in cleaning and / or drying an endoscopic instrument is also provided. The kit can include any of the cleaning and / or drying devices described above, and can further include an endoscopic instrument or endoscope such as any of the endoscopes described above with reference to FIG. 1 or others known to those of skill in the art. In addition to or in place of this, the kit can include cleaning brushes, swabs and / or sponges, enzymatic cleaners, disinfectants, and other devices and agents for sterilizing and / or disinfecting medical devices, lens desiccants, test strips or other sensors for determining the effectiveness of such cleaning and / or drying devices (i.e., detecting the presence or absence of proteins, biological materials, bacteria, fungi, viruses, proteins, ATP or bacterial markers, or other pathogens), personal protective equipment (PPE), such as a lens housing for transporting the lens to and from the reprocessing location, and various other devices used in the cleaning procedure and / or drying procedure such as a contaminant bag, in any combination.

[0107] 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 embodiments described above. The kit can include a non-sterile or a cleaned device and a sterilized drying device. Alternatively, the kit can include one device that functions to clean and concurrently dry the internal lumen of the endoscopic device. In an embodiment, the cleaning device can be one color and the drying device can be a different color to facilitate the user in differentiating the purpose of each device. This color coding helps to identify the use of each device and aids in clarifying which device is sterilized after opening. The color difference can be applied to navigation elements, cleaning / drying elements, pad printing lines, or other markers to clarify the different uses of each device.

[0108] In certain embodiments, the kit can include a cleaning device such as one of the above-described embodiments and an advancing element that can be a filament, wire, tube, or other element having the function of advancing into internal channels that are long, curved, or otherwise difficult to access due to being recessed or inside. In an embodiment, this element is gripped at the end after being pulled through the internal channel and can then be pulled through the channel as part of the drying process. Similarly, the advancing element can be advanced by pushing the element from the other end. This element can include versions that can advance air through the device into the channel including locations within the channel that are removed from the typical effects of forced air drying within the channel, well inside the channel.

[0109] In certain embodiments, the kit can include a drying device as described above and a cleaning device that includes a variable pressure region. The variable pressure central portion of the cleaning device is designed to generate a variable pressure between two circumferential elements and the wall of the channel being cleaned. That is, as the cleaning member is advanced inside the channel, the cleaning element is moved through the lumen, and when the scope and its channel are submerged in the cleaning fluid (as required by the scope manufacturer), the variable pressure design between the two circumferential elements creates a Venturi effect between the cleaning element and the wall of the endoscope channel. As a result, when the cleaning fluid flows across the variable pressure region, this region affects the fluid flow such that the fluid crosses from a high pressure region to a low pressure region and then moves to another high pressure region between the two cylindrical elements and returns pressure-wise, or in an embodiment, moves from low pressure to high pressure and then back to low pressure. This induces the cleaning fluid at the location of the channel wall at high speed and force, thereby removing more biological material and other debris than conventional devices. A more complete description of such a cleaning device can be found in U.S. Patent Application No. 17 / 509,304, filed on October 245, 2021, and assigned to the applicant of the present invention, the complete disclosure of which is incorporated herein by reference for all purposes.

[0110] Figure 8 shows another embodiment 800 of a cleaning and / or drying device. As shown, device 800 includes a plurality of cleaning and / or drying elements 300, and 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 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 joined to each other at the proximal and distal end portions.

[0111] The variable pressure region 306 includes a constriction section coupled to the proximal contact element 302, a diffuser section coupled to the distal contact element 304, and a throat section that couples the diffuser section and the constriction section. The throat section has a diameter smaller than the diameters of the contact elements 302, 204 and larger than the diameters of the diffuser section and the constriction section. This design redirects the cleaning fluid (or air when applicable) from the static interaction point with the wall of the sight glass channel to a dynamic interaction point where the cleaning and / or drying member induces the fluid or air against the wall of the sight glass channel by pressure, thereby enhancing the stripping action of the chemical agent of the cleaning fluid (or air in the case of drying), thus enhancing the performance of the cleaning fluid (or air).

[0112] The variable pressure region 306 can include a reverse partial Venturi shape, a parabolic shape, a variable slope shape, or other shape that generates a variable pressure between two cylindrical bodies and the wall of the channel to be cleaned, thereby increasing the force that projects the cleaning fluid or air against the channel wall when advancing the cleaning and / or drying member.

[0113] In an exemplary embodiment, the throat section is substantially cylindrical. The constriction section preferably expands in diameter from the contact section 302 to the throat section, and the diffuser section preferably reduces in diameter from the throat section to the contact section 304, thereby creating a Venturi effect between the distal and proximal end portions 302, 304 of the cleaning and / or drying element 310.

[0114] In a preferred embodiment, the variable pressure region 306 has an inverse partial venturi shape with three separate zones having different distances from the wall of the viewing lens channel, which creates an accelerated hydrodynamic action that projects a cleaning fluid (or air) onto the channel wall for more substantially cleaning or a similar action in the case of air. These zones include a contraction section that is the starting zone where the cleaning fluid (or air) is present on the other side of the first cylindrical element. The contraction section is the starting zone where the space available to the fluid changes and decreases as the cleaning and / or drying element 300 advances, causing the fluid to accumulate and undergo a pressure change, and the fluid (or air) is directed into a throat section that further changes the pressure between the cleaning and / or drying element and the channel wall. The throat section, where the shape available to the fluid becomes even smaller 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 when advancing the cleaning element 300 and / or an acceleration of the air when advancing the drying element 300, followed by a diffuser section that promotes the diffusion of the cleaning fluid (or air) at an accelerated velocity as the fluid (or air) exits the throat section. These sections between the cylindrical elements together generate sufficient hydrodynamic forces to remove bacteria, biological matter, and debris from the wall of the endoscope channel in the case of the cleaning fluid or similar forces to move water and moisture to dry the endoscope channel in the case of air. This hydrodynamic force applied to the air is also sufficient to remove substantially all moisture and fluid from the lumen during the drying process.

[0115] The inclination angle of the contraction section (defined as the angle formed between the vertical section of the conical section 302 and the inclined portion of the contraction section) may vary depending on the diameter of the channel being cleaned, the viscosity of the fluid (or the thickness of the air), and other factors, and must be sufficient to facilitate a variable pressure flow of the cleaning fluid or air between the cylinders when advancing the cleaning and / or drying elements. In certain embodiments, the contraction section defines an angle between the proximal end portion (i.e., the contact section 302) and from about 4 degrees to about 85 degrees, preferably from about 15 degrees to about 30 degrees. Similarly, the diffusion section defines an angle between the distal end portion (i.e., the contact section 304) and from about 4 degrees to about 85 degrees, preferably from about 15 degrees to about 30 degrees. Of course, it will be recognized that the various pressure regions 306 can have more than one inclined shape, curved shape, variable shape, or other shape that aids in varying the pressure between the two cylindrical elements 302, 304.

[0116] Similarly, the angle between the contraction and diffusion sections and the throat section 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 a variable pressure flow of the cleaning fluid or air between the cylinders when advancing the cleaning and / or drying elements. In certain embodiments, this angle is from about 10 degrees to about 50 degrees, preferably from about 15 degrees to about 30 degrees, more preferably from about 20 degrees to about 25 degrees.

[0117] The length and diameter of each section of the variable pressure region 306 are preferably selected to optimize the Venturi effect and will vary based on the diameter of the inner lumen, the viscosity of the fluid or air, and other factors. For example, in a lumen having a diameter of about 4.2 mm, the length of the throat section 310 can be from about 2 mm to 10 mm, preferably from about 3 mm to 5 mm, more preferably about 4 mm. The outer diameter of the throat section will also depend on the diameter of the inner lumen, as well as the diameters of the contraction and diffusion sections. In certain embodiments, the throat section is smaller in diameter than the inner lumen, but greater than 50% of the lumen diameter, preferably greater than about 60% of the lumen diameter, more preferably equal to or greater than about 70% of the lumen diameter (e.g., about 3 mm for a lumen having an inner diameter of about 4.2 mm).

[0118] The Venturi effect generated by the variable pressure region 306 affects the fluid flow such that the cleaning fluid or air is directed toward the channel wall with increased force, similar to the Venturi effect that occurs when the thumb is placed to partially cover the end of a water hose to enhance the force of the water discharged from the hose as the fluid flow (air flow if applicable) crosses a low pressure region between two cylindrical elements and moves to another high pressure region and returns pressure-wise. This variable pressure design means that when the cleaning and / or drying element 300 is attached to the navigation element and withdrawn or pulled through the sight glass channel, the cleaning fluid or air within the channel and between the cylindrical element and the wall of the endoscope channel moves across the variable pressure region between the two cylindrical spheres, generating an injection of cleaning fluid to pressure wash the channel wall of the endoscope channel with the cleaning fluid or an air pressure to dry the channel wall.

[0119] This unique feature has a powerful effect of enhancing the cleaning fluid performance by redirecting the cleaning and / or drying elements from the static interaction points of the fluid with the walls of the sight glass channel to dynamic interaction points where the cleaning fluid (or air) is directed by pressure towards the walls of the sight glass channel, enhancing the stripping action of the chemical agents of the cleaning fluid. In embodiments, the cleaning fluid (or air) is directed by a varying and increasing fluid (or air) pressure towards all of the channel walls, enabling the cleaning fluid to be directed by hydrodynamic forces (or air) into any scratches and cracks within the sight glass channel, including the ability to address changes in the surface undulations of the channel. A newly very effective cleaning performance and / or drying performance that can remove or dry debris, biological substances, and bacteria from the channel is shown by computational modeling using the mechanics of fluids and pressure to be generated by the application of the reverse Venturi principle for generating a variable pressure between two cylindrical elements.

[0120] In an embodiment, this variable pressure region 306 projects cleaning fluid or air against the channel walls at a pressure greater than the adhesion force of bacteria or moisture that may attach to the walls, creating a powerful advantage not present in existing brushing techniques. This function enhances cleaning in exactly the same way as when using a pressure washer with detergent to remove dirt from the side of a building or sidewalk, or enhances drying in exactly the same way as using an air dryer. This technological innovation improves cleaning fluid or drying in a new and powerful way, and further, the successful cleaning of the sight glass channel does not depend on the unpredictable wall contact forces of bristle brushes or pull-through cleaners, the static performance of cleaning detergents, or the performance of a single element such as drying based on evaporation over time. Instead, other performance characteristics that vary the channel cleaning performance are added to its design. The variable pressure region 306 of the cleaning / drying element 300 creates a hydrodynamic / pneumatic pressure that directs the cleaning detergent / air against the walls of the sight glass channel. The cleaning or drying operation, which is performed using a combination of mechanical pressure forces with forces from hydrodynamic pressure to enhance the performance of the cleaning fluid or air drying, consistently, predictably, and reproducibly achieves favorable results without providing damage to these critical channels when removing biological materials and debris from the channels of an endoscope or other endoscope instrument or removing moisture by drying.

[0121] The combination of the cylindrical element and the variable pressure element is important for generating hydrodynamic / pneumatic forces and adds additional cleaning and / or drying forces by contacting without causing trauma to the sight glass channel. These cylindrical elements add forces due to channel wall contact pressure as an additional cleaning or drying method for removing debris and biological materials from the channel walls or drying, and as complementary cleaning or drying performance that cooperates with the variable pressure element between the cylinders.

[0122] Here, an embodiment of a cleaning and / or drying device 800 having a plurality of cleaning and / or drying elements 300 will be described below. 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 preferably cylindrical elements having an outer diameter substantially the same as the inner diameter of the lumen to be cleaned (as will be discussed in detail below). In this embodiment, the cleaning and / or drying elements are joined to each other at the proximal and distal end portions. In an exemplary embodiment, the proximal end portion of one cleaning and / or drying element is integrated with the distal end portion of the next cleaning and / or drying element, although it will be recognized that other configurations are possible. For example, the cleaning and / or drying device 400 may have more than one cylindrical element disposed immediately adjacent to another cylindrical element at intervals that do not generate variable pressure, and thereafter or instead thereof may have a cylindrical element having an interval for generating variable pressure between the cleaning and / or drying element 300 and the wall of the channel to be cleaned between the next cylindrical element. In an embodiment, a series of cylindrical elements can be arranged with various intervals for generating variable pressure between the cylindrical elements and predetermined intervals for generating a constant pressure between the cylindrical elements.

[0123] The cylindrical elements 302, 304 can be manufactured in any shape and size that contacts and at least partially conforms to the wall of the channel being cleaned. In an embodiment, this includes tapered or reverse-tapered cylindrical elements, cylindrical elements that bend to contact each other, cylindrical elements that bend and do not contact another cylindrical element, or cylindrical elements that contact or do not contact the variable pressure shape between the cylindrical elements. The cylindrical elements need not be cylindrical, but it is necessary that they be able to cooperate with the remaining elements of the cleaning and / or drying device 400 to assist in generating the result of variable pressure, i.e., accelerating the fluid flow or air flow and thereby promoting the generation of a variable pressure region for directing the cleaning fluid or air against the channel wall by hydrodynamic or pneumatic pressure, and should have sufficient wall contact to be significant enough for this purpose.

[0124] The cleaning and / or drying device 800 includes two additional cylindrical elements 402, 404 at the distal end of the device 800. In this embodiment, the device 800 further includes a proximal tip element 802 and a proximal cylindrical centering element 804 disposed around the variable pressure region 306. The element 804 is preferably disposed around the constriction section 308 of the pressure region 306 between the diffuser section 312 and the throat section 310 (see FIG. 4 and the above description of these elements).

[0125] The centering element 804 is not disposed at the proximal tip of the device (as in the embodiment of FIG. 7B), but rather is disposed around the pressure region 306. The centering element 804 is sized such that its outer surface contacts the inner surface of the lumen of the endoscope device. When the device 800 is withdrawn or pushed through the lumen, the centering element 804 engages the inner surface of the lumen and moves (cleans) any biological material on this surface and / or moves (dries) moisture, moving these substances forward with the device 800. FIG. 27 shows a kit 900 that includes a water cylinder 902 having a straw 904 and a cleaning and / or drying device 910 for the straw 904. In this embodiment, the device 910 can be used to clean and / or dry the inner surface of drinking containers and their components, such as drinking straws, beverage containers, water containers, bottles, thermoses, syringes, watering cans, glass bottles, baby bottles, water cylinders, and insulated beverage containers, and drinking straws for any of these containers.

[0126] As shown, the device 910 includes a plurality of cleaning and / or drying elements 300, each including proximal and distal end portions 302, 304 as described above and a variable pressure region 306 between these end portions. 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 joined to each other at the proximal and distal end portions. The cleaning and / or drying device 910 includes two additional cylindrical elements 402, 404 at the distal end of the device 910.

[0127] In this embodiment, the device 910 further includes a proximal tip element 908 and a proximal cylindrical centering element 906 (formed proximal to the most proximal cleaning and / or drying element 300). The tip element 908 preferably includes a substantially cylindrical plug-shaped element that forms the proximal end of the device 910. The tip element 908 functions to guide the device 910 through the straw 904 and to move moisture and / or biological material from the inner surface of the straw. In certain embodiments, the device 910 can include a distal tip element (not symbolically shown) having substantially the same design as the proximal tip element 908.

[0128] FIG. 9 shows a kit 900 that includes a water cylinder 902 having a straw 904 and a cleaning and / or drying device 910 for the straw 904. In this embodiment, the device 910 can be used to clean and / or dry the inner surface of drinking containers and their components, such as drinking straws, beverage containers, water containers, bottles, thermos bottles, syringes, watering cans, glass bottles, baby bottles, water cylinders, and insulated beverage containers, and drinking straws for any of these containers.

[0129] As shown, the device 910 includes a plurality of cleaning and / or drying elements 300 each including proximal and distal end portions 302, 304 as described above and a variable pressure region 306 between these end portions. 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 joined to each other at the proximal and distal end portions. The cleaning and / or drying device 910 includes two additional cylindrical elements 402, 404 at the distal end of the device 910.

[0130] In this embodiment, device 910 further includes a proximal tip element 908 and a proximal cylindrical centering element 906 (formed proximal to the most proximal cleaning and / or drying element 300). The tip element 908 preferably includes a substantially cylindrical plug-shaped element that forms the proximal end of device 910. The tip element 908 functions to guide device 910 through straw 904 and to move moisture and / or biological material from the inner surface of the straw. In certain embodiments, device 910 can include a distal tip element (not shown symbolically) having substantially the same design as proximal tip element 908.

[0131] In certain embodiments, the drying device described above further includes a programmable motor (not shown) that can be part of or separate from the elongate member. The programmable motor is designed to withdraw the member from the internal lumen of endoscope 10 at a fixed or variable speed. Alternatively, the motor can be programmed using a specific algorithm corresponding to certain cleaning purposes. In one embodiment, the motor is programmed to withdraw the elongate member at a fixed speed based on a predetermined cleaning time required to completely absorb and remove biological material from the internal lumen. In an alternative embodiment, the motor is programmed to withdraw the elongate member in a series of individual steps, namely, holding the shaft in a specified location for a specified period of time, then withdrawing the shaft a specified distance, and then repeating these steps until the shaft is fully withdrawn and the cleaning procedure is complete.

[0132] The drying device described herein may include one or more sensors (not shown) along the elongate member for detecting biological substances, pathogens, liquids, or other particles within the endoscope 10. Suitable sensors can include PCT and microarray-based sensors, optical sensors (e.g., bioluminescence and fluorescence), piezoelectric sensors, potentiometric sensors, amperometric sensors, conductivity sensors, or nanosensors, among others. The device may further include an indicator, such as a display, configured to be coupled to the sensor and indicate the presence of biological substances, pathogens, liquids, or other particles detected by the sensor. The indicator has been confirmed to be effective for cleaning procedures and / or sterilization procedures and can be any suitable chemical indicator that causes a physical or chemical change visible to the human eye after exposure to certain parameters. The indicator and the sensor can be part of the same device or separate from each other.

[0133] All issued patents, published patent applications, and non-patent publications mentioned hereinbefore are hereby incorporated by reference in their entirety for all purposes to the same extent as if each individual issued patent, published patent application, and non-patent publication were specifically and individually indicated to be incorporated by reference.

[0134] Although some embodiments of this description are shown in the drawings, this description is not intended to be limited to these embodiments, as it is intended to cover a scope as broad as that permitted by the relevant art and as would be understood when reading this specification. Those skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting, exemplary embodiments. Features exemplified or described with respect to one exemplary embodiment can be combined with the features of other embodiments. Those skilled in the art will be able to devise various alternatives and modifications without departing from this description. Accordingly, this description is intended to cover all such alternatives, modifications, and variations. Furthermore, those skilled in the art will recognize further features and advantages of this description based on the above-described embodiments. Accordingly, this description is not limited by what is specifically shown and described, except as indicated by the claims.

Explanation of Reference Signs

[0135] 10 Endoscope 12 Proximal Handle 14 Elongated Shaft 16 Fluid Delivery System 20 Water Cylinder Connector

Claims

1. A drying device for use with endoscopic instruments, A slender member configured to advance through the lumen inside the endoscopic instrument, At least one drying member attached to a portion of the elongated member, wherein the drying element includes at least a portion having an outer diameter larger than the outer diameter of the elongated member, Includes, The elongated member and the drying member are sterilized or disinfected. Drying device.

2. The device according to claim 1, wherein at least a portion of the drying member is molded and configured such that the elongated member substantially maintains contact with the wall of the lumen as it advances through the lumen.

3. The device according to claim 1, wherein the drying member includes one or more substantially annular members extending radially outward from the drying member.

4. The device according to claim 3, wherein the annular member is a disk.

5. The device according to claim 3, wherein the annular member is a fin.

6. The device according to claim 3, wherein the annular member is a squeegee.

7. The device according to claim 3, wherein the annular members are spaced apart from each other along the elongated members.

8. The device according to claim 3, wherein the annular member comprises an absorbent material.

9. The annular member includes a first annular member having a first diameter and a second annular member having a second diameter. The first diameter is larger than the second diameter. The device according to claim 3.

10. The device according to claim 1, wherein the elongated member includes a filament, a wire, or a tube.

11. The device according to claim 3, wherein the annular members are spaced substantially equally apart from each other along the elongated member.

12. It further includes first, second, and third annular members, The first and second annular members are spaced further apart from each other than the second and third annular members. The device according to claim 3.

13. The device according to claim 1, further comprising a centralizing element connected to either the elongated member or the drying member, and configured to position the drying member at the center within the lumen.

14. The device according to claim 13, wherein the centralizing element has an outer dimension of about 50 percent to about 90 percent of the inner diameter of the lumen.

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

16. The kit according to claim 15, wherein the pressure gradient causes an increase in the relative velocity between the drying member and the fluid and air in the lumen as the drying member moves forward through the lumen.

17. The kit according to claim 15, 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.

18. The central portion of the drying member includes a shrinkage section coupled to the proximal end portion, a diffusion section coupled to the distal end portion, and a throat section connecting the diffusion section and the shrinkage section. The throat section has a diameter smaller than the diameter of the proximal end portion and the distal end portion, and larger than the diameter of the diffusion section and the contraction section. The kit according to claim 15.

19. The contraction section has an increasing diameter from the proximal end portion to the throat section, and the diffusion section has a decreasing diameter from the throat section to the distal end portion. The throat section is substantially cylindrical. The kit according to claim 18.

20. The kit according to claim 15, wherein the drying device further comprises a tip element having a substantially cylindrical shape and being sized to advance through the lumen of the drinking straw.

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