Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
  • A61B1/12—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with cooling or rinsing arrangements
  • A61B1/121—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with cooling or rinsing arrangements provided with means for cleaning post-use
  • A61B1/125—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with cooling or rinsing arrangements provided with means for cleaning post-use using fluid circuits
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
  • A61B90/70—Cleaning devices specially adapted for surgical instruments
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/0043—Catheters; Hollow probes characterised by structural features
  • A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
  • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
  • A61M25/06—Body-piercing guide needles or the like
  • A61M25/0662—Guide tubes
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B08—CLEANING
  • B08B—CLEANING IN GENERAL; PREVENTION OF FOULING IN GENERAL
  • B08B9/00—Cleaning hollow articles by methods or apparatus specially adapted thereto
  • B08B9/02—Cleaning pipes or tubes or systems of pipes or tubes
  • B08B9/027—Cleaning the internal surfaces; Removal of blockages
  • B08B9/04—Cleaning the internal surfaces; Removal of blockages using cleaning devices introduced into and moved along the pipes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
  • A61B90/70—Cleaning devices specially adapted for surgical instruments
  • A61B2090/701—Cleaning devices specially adapted for surgical instruments for flexible tubular instruments, e.g. endoscopes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M2025/0019—Cleaning catheters or the like, e.g. for reuse of the device, for avoiding replacement

Definitions

• Endoscopes are high technology instruments, typically having advanced, expensive optical chips at the distal end of the scope to facilitate exceptional visualization. These imaging signals are captured on the chip and communicated in turn through high definition image transfer technology involving sophisticated software and imaging processing hardware that processes the optical signals. These signals in turn are translated and projected through the software and processor at numerous frames per second to an imaging screen, console or other means of transmitting the image to a user distant from the optical chip.
• Biofilm can replicate, detach and then attach in a new location and repeat this process, while also recruiting other organisms into the biofilm during the process, creating additional multi-drug resistant organisms (MDRO) that cannot be effectively treated with antibiotics. MDRO infections are exceptionally dangerous and have resulted in multiple deaths around the world from contaminated endoscopes that were not reprocessed successfully.
• the cleaning brush acts as a tool that not only partially removes debris in the channel, but it also shovels or pushes contaminates out of the biopsy channel into the most difficult to clean area on the scope, with the highest level of scope-related infection risk.
• the direction for passing cleaning brushes through the biopsy channel and suction channel i.e. pass from distal end to proximal end exit of the biopsy channel.
• the cleaning brushes themselves also have a number of notable limitations that inhibit consistent, repeatable scope reprocessing success.
• Pictures of the interior of the scope biopsy channels after cleaning with a nylon wire bristle brush reveals that the bristles deflect while being passed through the channels, leaving streaks along the interior of the channels rather than a clean consistent cleaning result.
• These channels can be highly contaminated with debris, biomatter and bacteria after experiencing repeated passing of therapeutic instruments during procedures, as well as from the actuation of suction to remove debris, mucus and other biomatter during a procedure.
• Using brushes that deflect and cause streaks means that channel cleaning is incomplete and will be highly variable.
• biomatter and debris must be successfully removed in order to successful disinfection and reprocess a scope. Left behind biomatter and debris acts as a shield over pathogens that may reside in these channels (including naturally occurring bacteria from the patient) preventing successful treatment with disinfectants and sterilants that kill the pathogens and make the scope safe for reuse with the next patient.
• the biopsy channel is typically made with PTFE or other polymeric material. It is designed to allow for predictable passing of instruments and typically has a low coefficient of friction to support instrument passing.
• the channel is compatible with a wide range of instruments and the diameters of the instruments passed are meaningfully smaller than the diameter of the endoscope’s biopsy/working channel, providing room for safe advancement of instruments through the channel. That said, occasionally instruments are not used correctly, such as attempting to open a biopsy forceps in the biopsy channel, or attempting to withdraw a biopsy forceps back through the channel without having the forceps properly closed.
• the pull thru brush cleaner is designed with five cylindrical fins, which are arranged in very close proximity to each other with two of the fins clustered together, followed by a larger space and then three additional fins clustered together.
• the fins are a flexible polymer overmolded on to a rod of stiffer material that is used to advance the cleaner down the scope biopsy channel from the proximal end of the scope to the distal end, while the scope is submerged in cleaning fluid.
• the space between each cluster of fins is uniform and the polymer between the fins is a thin, uniform thickness that is overmolded to adhere to the cylindrical monofilament.
• the benefit of the pull thru cleaner is less trauma to the walls of the biopsy channel compared to a wire brush cleaner. There is also some evidence that the pull thru cleaner is able to more effectively remove biomatter from a contaminated biopsy channel.
• the pull thru cleaning brush is designed to pull debris from the proximal end of the biopsy channel to the high-risk, difficult to clean distal end of the scope, raising the potential contamination of the distal end as it attempts to clean the scope’s biopsy channel.
• An additional limitation with these devices is that the cylindrical fins are significantly oversized relative to the diameter of the biopsy channel, resulting in meaningful deflection at the end of the fins, which creates a buckling effect that results in a gap between the fin and biopsy channel. This gap or lack of consistent wall conformance can mean that not all potential contaminants are addressed when the pull thru brush is moved through the biopsy channel.
• this gap means that a change in the surface of the wall of the biopsy channel, such as a change due to a scratch or crevasse from an instrument pass, is unlikely to be addressed by the pull thru brush as it is moved through the biopsy channel.
• the fins are unable to impact scratches and crevasses as the fins pass over injuries to the channel wall.
• Devices and methods are provided for cleaning biomatter, tissue or other debris from endoscopic instruments, such as endoscopes, particularly internal lumens or other spaces within the endoscopic instruments. Devices and methods are also provided for drying the internal lumens of these endoscopic instruments after they have been cleaned, and for testing to confirm successful cleaning and drying.
• the disclosed innovations address the multiple limitations with current approaches for cleaning and/or drying lumens or channels, and provide new, important capabilities to improve cleaning and drying performance.
• the devices disclosed herein overcome the notable defects with the current channel cleaning approaches for endoscopes wherein brushes and cleaning fluids are not designed to work together and complement each technology’s respective capabilities. These innovations not only address the current issues with brushes, but also complement and enhance the effectiveness of cleaning fluids used in the channels of endoscopes.
• certain embodiments provide the advantages that the lumen(s) of endoscopic instruments can be cleaned without creating defects in the surfaces of the internal lumen. This increases the life of the instrument and allows the instrument to be cleaned multiple times without providing additional areas for biomatter, pathogens or other debris to reside.
• these innovations provide devices that can rapidly and consistently dry the internal lumens or channels of endoscopic instruments .
• the proximal and distal end portions of the drying member create consistent circumferential contact with the interior wall of an endoscope channel, such as a biopsy or suction channel.
• these channel contact elements preferably have a substantially circumferential, cylindrical or conical shape with at least one portion of the element having a diameter approximately equal to or slightly larger than the diameter of the internal lumen.
• the diameter of the proximal and distal end portions is about 1 to about 1.5 times the diameter of the internal lumen, preferably about 1 to about 1 .25 times this diameter. This avoids deflection of the proximal and distal end portions, thereby reducing the buckling and the creation of a gap between the drying element and the internal wall of the lumen.
• the variable pressure region between the two cylindrical elements may include an inverted, partial venturi shape, a parabolic shape, a variable slope shape or such other shape that creates variable pressure or a vortex between the two cylinders and the wall of the channel being dried, thereby increasing the force against the channel wall when the drying member is advanced.
• the throat section is substantially cylindrical.
• the contraction section preferably increases in diameter from the proximal end portion to the throat section and the diffusion section preferably decreases in diameter from the throat section to the distal end portion, thereby creating either a vortex, a venturi effect, an inverted or reverse venturi effect or other variable pressure between the distal and proximal end portions of the drying element.
• the variable pressure region of the drying element is configured to generate an average or mean pressure across the distance between the proximal and distal end portions of the drying element of at least about 10 Pa, preferably about 20 Pa and more preferably about 30 Pa. In an exemplary embodiment, the mean pressure is about 36 Pa. [0043] The variable pressure region of the drying element is also configured to generate a peak shear stress of at least about 4 Pa in at least one area between the distal and proximal end portions of the drying element, preferably at least about 5 Pa and more preferably at least about 8 Pa. The average or mean shear stress across the distance between the proximal and distal end portions of the drying element is at least about 1 Pa, preferably about 2 Pa and more preferably greater than 2.5 Pa. In an exemplary embodiment the mean shear stress is about 2.8 Pa.
• 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.
• the programmable motor is preferably configured to withdraw the elongate member through the lumen a specified distance for a specified duration of time.
• the motor may be programmed to withdraw the elongate member at a specific velocity that optimizes the increased velocity created by the variable pressure region within the drying member, thereby ensuring that the internal lumen is sufficiently dried without damaging the surface.
• the cleaning device may also comprise any of the combinations of the elements described above with respect to the drying device.
• the variable pressure central portion of the cleaning device is designed to create variable pressure between the two circumferential elements and the wall of the channel being cleaned.
• the variable pressure design between the two circumferential elements creates either a vortex, a venturi effect, an inverted or reverse venturi effect or other variable pressure between the cleaning element and the walls of the endoscope channel when the cleaning element is moved through the lumen.
• the drying device of the kit comprises an advancement element that may be a filament, wire, tube or other element capable of advancement into an internal channel, including a long, curved, or other channel that is difficult to access because it is recessed or internal.
• this element can be grasped at an end once it is pulled through the internal channel and then pulled through the channel as part of the drying process. It also can be advanced from the other end through pushing the advancement element.
• This element may include a version that is able to advance air through the device and into the channel, including to a removed location well inside the channel and beyond the typical effectiveness of forced air drying in a channel.
• the elongate member of the drying device comprises a filament, wire, tube, shaft or other element capable of advancement into an internal channel, including a long, curved, or other channel that is difficult to access because it is recessed or internal.
• this element can be grasped at an end once it is pulled through the internal channel and then pulled through the channel as part of the drying process. It also can be advanced from the other end through pushing the advancement element.
• This element may include a version that is able to advance air through the device and into the channel, including to a removed location well inside the channel and beyond the typical effectiveness of forced air drying in a channel.
• the drying element of the invention may be any shape or form that can displace water and moisture through advancement and withdrawal, including a squeegee, disc, fin, cylinder, series of absorptive strips, venturi or inverted venturi, oblong and round shapes, a ball or spherical shaped drying element.
• the fins, discs, squeegees or other annular member, or other drying member may be at any angle to the channel wall that promotes and enhances drying, including perpendicular, angled backward and an angle of between 1 and 89 degrees, angled forward at an angle of between 1 and 89 degrees or any other angle that promotes drying. In embodiments, these angles shall not be limited to this description and shall vary based on what is most effective for the drying for a given channel drying application.
• the drying member may comprise a series of one or more cylindrical squeegees that are designed to make wall contact with the internal walls of the channel to remove fluid and moisture from the channel.
• These cylindrical squeegees may be arranged in any manner that is effective at removing fluid and moisture from the channel.
• the spacing between squeegees and any other elements, including drying elements may be any spacing that supports rapid and predictable channel drying, including a spacing of 1 mm, 1.25 mm, 1.5 mm, 2 mm, close spacing of 1.25 mm and then a 4 mm gap and then spacing of 1 .25 to 1 .5 mm or other spacing closer or farther or more variable that optimizes and supports rapid and predictable channel drying. Spacing, diameters and alignment and grouping of drying elements may vary based on channel size, channel material, the number of curves to navigate around, the number of junctions with other channels, if any, the channel dryer material, and other factors specific to the given channel drying application, in embodiments.
• the rod member may comprise one continuous polymer rod with the looped end of the rod member comprising one thickness or diameter and the straight end of the rod member comprising two thicknesses or two 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 may be fused or bonded together, laminated together, or coextruded.
• the drying device includes a centering element, so that the drying element(s) remain centered as they are advanced through the channel to dry.
• This centering element prevents a drying element from losing contact with the wall of the channel being dried, enhancing drying action.
• the centering element may be any shape that keeps the device generally centered in the lumen and prevents this deflection, with a preferred embodiment being a cylindrical shape with a tapered distal end.
• the centering element is between 50 percent and 90 percent of the diameter of the lumen being cleaned, with a further preferred embodiment having a diameter or height between 70 percent and 85 percent of the diameter of the lumen being cleaned.
• the centering element may comprise a series of shaped elements projecting from the elongate member or the navigation member. This series of shaped elements may, for example, comprise struts, spikes, or other projections extending radially outward from the elongate member and sized to substantially center the elongate member and/or the drying/cleaning elements within the internal channel of the endoscopic device.
• a kit for cleaning and drying an endoscopic instrument comprises a drying/cleaning device having an elongate member configured for advancement through the lumen within the endoscopic instrument and at least one cleaning/drying member coupled to a portion of the second elongate member.
• the cleaning/drying member comprises distal and proximal end portions and a central portion between the distal and proximal end portions and wherein the central portion is shaped to create a pressure gradient along the central portion from the distal end portion to the proximal end portion.
• the drying/cleaning device is configured to both clean and dry an internal lumen while being passed therethrough
• this version may be particularly useful to clean and dry after the use of liquid chemical sterilants and disinfectants.
• the invention is configured for use with an endoscope.
• the advancing element is a polymer filament, wire or tube.
• the materials for the advancing element are any that are appropriate for the application, which, in embodiments, could be polypropylene, PET, nylon, PEEK, PTFE, ETFE, polyurethane, high or low density polyethylene, or other suitable polymer material.
• the advancing element could also be a metal wire (including stainless steel, nitinol or other material), or a combination of materials, including polymer reinforced by a wire, or a wire covered with a polymer or a combination thereof.
• the drying element is injection molded, 3d printed, or otherwise formed or otherwise formed or attached either over the advancing element or connected or glued to the advancing element.
• the drying element is any durometer that aids in drying the channel, though in a preferred embodiment, the durometer of the material is between 35 and 75 Shore A.
• the drying element may be made of any elastomer or any elastic material, including pebax, polyurethane, santoprene, silicone, high or low density polyethylene, EVA and other elastomeric materials.
• the drying element could be a combination of materials, including a combination of hard and soft materials with varying elasticity.
• a version of the drying portion of the invention may include material that can absorb water, such as a sponge, an absorptive cloth or other material that can absorb and hold moisture and water.
• This material may be attached to the advancing element as a cylinder, as strips of material in singular or various lengths, as overlapping material, as a round ball, or as any other shape that aids in removable of water and moisture from a channel as the advancing element is passed through a channel.
• This absorptive material may be at the end or beginning of a drying element or interspersed between other drying elements, such as squeegees or fins.
• the drying element of the invention may be any shape or form that can displace water and moisture through advancement and withdrawal, including a squeegee, cylinder, series of absorptive strips, venturi or inverted venturi, oblong and round shapes, a ball or spherical shaped drying element.
• the invention may include coatings that aid in attracting or repelling water and in navigation by changing levels of friction.
• the invention may have a lumen that allows air to be blown through the invention to delivery forced air deep inside a channel in close or direct proximity to a channel wall
• a method for drying one or more lumens within an endoscopic instrument comprises advancing an elongate member having at least one drying member through the lumen within the endoscopic instrument and creating a pressure gradient along a central portion of the drying member.
• This pressure gradient causes an increase in a relative velocity between the drying member and any air or fluid within the lumen as the drying member is advanced through the lumen.
• the increased velocity of the fluid or air increases the shear stress between the fluid or air and the lumen wall, thereby creating more force to dry the wall.
• the central portion of the drying member comprises a contraction section coupled to the proximal end portion, a diffusion section coupled to the distal end portion and a throat section coupling the diffusion and contraction sections, wherein the throat section has a diameter less than the diameter of the proximal and distal end portions and greater than a diameter of the diffusion and contraction sections.
• the method further comprises centering the drying member within the lumen as the drying member is advanced through the lumen.
• the centering element is preferably smaller than the diameter of the lumen through which the device is being advanced, but has a significant enough size to prevent misalignment and deflection of the navigation element to one side or another of the lumen as it navigates, including as the drying element is pulled or pushed around curves, corners and junctions of various lumens (including Y junctions).
• the method comprises introducing a guidance element through a first opening in a lumen of an 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 guidance element.
• the guidance element engages and couples with the drying device such that the drying device can be withdrawn towards the first opening of the lumen with the guidance element.
• the endoscope lumen comprises first and second lumens coupled to each other at a junction, such as the Y junction between the biopsy and suction channels in an endoscope.
• the method further comprises introducing the guidance element through the first lumen past the junction into the second lumen and advancing the elongate drying device through the second lumen such that the elongate drying device engages the guidance element.
• the guidance element may then be used to withdraw the drying device past the junction and through the first lumen. This ensures that the drying device dries the biopsy channel, rather than being deflected and continuing past the Y-junction proximally further into the suction channel.
• the endoscope lumen includes a turn or bend having a relatively small radius of curvature that would otherwise be difficult to advance the drying element therethrough.
• the guidance element is introduced through a lumen on one side of the turn and advanced therethrough. The drying device is advanced or retracted through the lumen on the other side of the turn until it engages with the guidance element. The guidance element is then withdrawn to pull the drying device through the turn.
• the guidance element may comprise a tubular sheath or similar device having a distal end portion configured for engaging an end portion of the cleaning element.
• the tubular sheath is removably coupled to the cleaning element.
• the tubular sheath may have an inner diameter larger than an outer diameter of the proximal end portion of the elongate drying element, and may be further configured to deflect or otherwise direct the drying element past a junction or other tortuous area in the lumen
• the tip of the guidance element is angled to further conform to the shape of a multi-channel internal junction in the scope.
• the end of the navigation element may have a flange that is larger than the entry opening to the specific scope channel where the navigation element is inserted, so that the navigation element cannot be advanced entirely into the channel and result in difficult withdrawal.
• the navigation element may not have a flange, but may have a marker, including for example, a pad printed or other line, demarcating the maximum recommended point of advancement of the navigation element into the scope or other channel.
• the cleaning/drying device may have one or more absorbent sponges placed in front of or at the end of the cleaning/drying device or in between one or more of the cylindrical elements to absorb biomatter and debris.
• the absorbent sponges may be of a single cell configuration or have multiple sponges with different cell configurations to provide scrubbing, absorption, lifting, diffusion of cleaning fluid, or a combination of these attributes.
• the absorbent sponges may comprise any material that absorbs biomatter, fluid or other debris, such as a polymer, foam, sponge, bamboo, hemp, microfibers, polyurethane, polyvinyl alcohol, or the like.
• the cleaning member comprises a sponge-like material, such as cellulose, dry, natural and/or compressed cellulose.
• the material comprises a mixture of cellulose and compressed cellulose that allows the sponge to expand when it is hydrated.
• the material is selected such that the sponge has the ability to expand to at least the internal surface of the lumen, while, in a preferred embodiment, maintaining sufficient absorbability to absorb a volume of material or fluid at least equal to the volume of the segment of the lumen it occupies.
• the sponges are soft and atraumatic when immersed in fluid, and expand to a size that is at least sufficient to remove debris from the channel being cleaned (and/or remove moisture and fluid from the channel), and in a preferred embodiment is larger than the channel being cleaned.
• the sponges may be any shape and size that conforms and aids in cleaning the scope’s channel, including by way of example, not limitation, cylindrical in shape, spiral in shape, conical, triangular, square or any combination thereof.
• the cleaning member or the drying member may have more than one cylindrical element placed in close proximity to another, including one or more elements, cylindrical or other shapes, with a spacing that does not create variable pressure on average between the elements, followed by or, alternatively, before, a cylindrical element with a spacing between the next cylindrical element that creates variable pressure between the cleaning/drying member and the wall of the channel being cleaned.
• a series of cylindrical elements may be organized in various spacing to create variable pressure between the cylindrical elements and certain spacing to create constant pressure between the cylindrical elements.
• the devices disclosed herein may be used to dry and/or clean in-dwelling devices.
• the devices may further include a sheath or similar structure to cover the cleaning and/or drying elements and/or the navigation element while translating through the lumen of the instrument to avoid disturbing biomatter and any accumulated biofilm therein.
• the system may also include a measuring device, such as a marker on the navigation element or a separate elongated element to confirm positioning of the device within the lumen of the catheter.
• the polymers that form the cleaning and/or drying elements may expand once the sheath has been withdrawn.
• electrically responsive polymers may be used to change shape and enlarge with the application of energy, causing them to expand and contact the walls of the catheter, or at least in part.
• the device may include a coating that is hydrophobic.
• the device is superhydrophobic and/or oleophobic.
• the device is anti-infective and hydrophobic.
• the device is anti-infective and superhydrophobic.
• anti-inflammatory coatings are incorporated into the device.
• the anti-inflammatory coatings may comprise a hydrophilic material, or a coating is hydrophilic.
• FIG. 1 illustrates a representative endoscope for use with the disinfection systems and methods disclosed herein;
• FIG. 2 is a cross-sectional view of a representative endoscope, showing one or more lumens within the endoscope;
• FIG. 3 illustrates damage that may occur to a representative endoscope during use and/or cleaning with conventional devices
• FIG. 4 is a side view of an exemplary embodiment of a cleaning and/or drying element
• FIG. 5A illustrates a fluid pressure distribution created by the cleaning and/or drying element of FIG. 4;
• FIGS. 6A and 6B illustrate direct and shear stress pressures created against and along an internal lumen with the cleaning and/or drying element of FIG. 4;
• FIG. 7A is a side view of a cleaning and/or drying device including multiple cleaning and/or drying elements coupled to each other;
• FIG. 7B is a side view of another embodiment of a cleaning and/or drying device with multiple cleaning and/or drying elements
• FIG. 7C is a perspective view of another embodiment of a cleaning and/or drying device
• FIG. 8 is a top view of a system for cleaning and/or drying a lumen within an endoscopic device
• FIG. 9 is a side view of a cleaning and/or drying element and a navigation element
• FIG. 10 is a side view of an alternative embodiment of a cleaning and/or drying device;
• FIGS. 11A-11 D illustrate further alternative embodiments of a cleaning and/or drying device;
• FIG. 12 is a side view of another embodiment of a cleaning and/or drying device incorporating a cleaning and/or drying element and a navigation element;
• FIG. 13 is a side view of a cleaning and/or drying element and a navigation device, illustrating a method for removably coupling the devices together;
• FIG. 14 illustrates another method for removably coupling a cleaning and/or drying device to a navigation device
• FIG. 15 illustrates yet another method for removably coupling a cleaning and/or drying device to a navigation device
• FIG. 16 illustrates test data from a comparison of pressures created by the cleaning and/or drying element disclosed herein and a prior art device
• FIG. 17 illustrates the peak pressure cleaning and/or drying area created by the devices of FIG. 16;
• FIG. 18 illustrates the positive pressure cleaning and/or drying areas created by the devices of FIG. 16;
• FIG. 19 is a perspective view of an embodiment of a cleaning and/or drying device according to the alternative embodiment.
• FIG. 20 illustrates use of the cleaning and/or drying device of FIG. 19 within a representative lumen of an endoscopic instrument
• FIGS. 21A and 21 B illustrate alternative embodiments of the cleaning and/or drying device of FIG. 19;
• FIG. 22 is a perspective view of another embodiment of a cleaning and/or drying device;
• FIG. 23 is a cross-sectional view of a distal end portion of the cleaning and/or drying device of FIG. 22;
• FIG. 24 illustrates another embodiment of a cleaning and/or drying device
• FIG. 25 illustrates a guidance element for use with the cleaning and/or drying devices disclosed herein.
• FIG. 26 illustrates another guidance element for use with the cleaning and/or drying devices disclosed herein.
• endoscope refers generally to any scope used on or in a medical application, which includes a body (human or otherwise) and includes, for example, a laparoscope, arthroscope, colonoscope, gastroscope, duodenoscope, endoscopic ultrasound scope, bronchoscopes, enteroscope, cystoscope, laparoscope, laryngoscope, sigmoidoscope, thoracoscope, cardioscope, and saphenous vein harvester with a scope, whether robotic or non-robotic, or in a non-medical application.
• a laparoscope arthroscope, colonoscope, gastroscope, duodenoscope, endoscopic ultrasound scope, bronchoscopes, enteroscope, cystoscope, laparoscope, laryngoscope, sigmoidoscope, thoracoscope, cardioscope, and saphenous vein harvester with a scope, whether robotic or non-robotic, or in a non-medical application.
• scopes When engaged in remote visualization inside the patient’s body, a variety of scopes are used. The scope used depends on the degree to which the physician needs to navigate into the body, the type of surgical instruments used in the procedure and the level of invasiveness that is appropriate for the type of procedure. For example, visualization inside the gastrointestinal tract may involve the use of endoscopy in the form of flexible gastroscopes and colonoscopes and specialty duodenum scopes with lengths that can run many feet and diameters that can exceed 1 centimeter. These scopes can be turned and articulated or steered by the physician as the scope is navigated through the patient.
• scopes include one or more working channels for passing and supporting instruments, fluid channels and washing channels for irrigating the tissue and washing the scope, insufflation channels for insufflating to improve navigation and visualization and one or more light guides for illuminating the field of view of the scope.
• Smaller and less flexible or rigid scopes, or scopes with a combination of flexibility and rigidity are also used in medical applications.
• a smaller, narrower and much shorter scope is used when inspecting a joint and performing arthroscopic surgery, such as surgery on the shoulder or knee.
• a shorter, more rigid scope is usually inserted through a small incision on one side of the knee to visualize the injury, while instruments are passed through incisions on the opposite side of the knee. The instruments can irrigate the scope inside the knee to maintain visualization and to manipulate the tissue to complete the repair
• scopes may be used for diagnosis and treatment using less invasive endoscopic procedures, including, by way of example, but not limitation, the use of scopes to inspect and treat conditions in the lung (bronchoscopes), mouth (enteroscope), urethra (cystoscope), abdomen and peritoneal cavity (laparoscope), nose and sinus (laryngoscope), anus (sigmoidoscope) and other aspects of the gastrointestinal tract (gastroscope, duodenoscope, colonoscope), chest and thoracic cavity (thoracoscope), and the heart (cardioscope).
• bronchoscopes to inspect and treat conditions in the lung
• enteroscope to inspect and treat conditions in the mouth
• cystoscope to inspect and treat conditions in the abdomen and peritoneal cavity
• laparoscope laparoscope
• laparoscope to inspect and treat conditions in the abdomen and peritoneal cavity
• laparoscope to inspect and treat conditions in the abdomen and peritoneal cavity
• laparoscope to inspect and treat conditions in the abdomen
• scopes may be inserted through natural orifices (such as the mouth, sinus, ear, urethra, anus and vagina) and through incisions and portbased openings in the patient’s skin, cavity, skull, joint, or other medically indicated points of entry.
• diagnostic use of endoscopy with visualization using these medical scopes includes investigating the symptoms of disease, such as maladies of the digestive system (for example, nausea, vomiting, abdominal pain, gastrointestinal bleeding), or confirming a diagnosis, (for example by performing a biopsy for anemia, bleeding, inflammation, and cancer) or surgical treatment of the disease (such as removal of a ruptured appendix or cautery of an endogastric bleed).
• a representative endoscope 10 includes a proximal handle 12 adapted for manipulation by the surgeon or clinician coupled to an elongate shaft 14 adapted for insertion through an endoscopic or percutaneous penetration into a body cavity of a patient.
• Endoscope 10 further includes a fluid delivery system 16 coupled to handle 12 via a universal cord 15.
• Fluid delivery system 16 may include a number of different tubes coupled to internal lumens within shaft 14 for delivery of fluid(s), such as water and air, suction, and other features that may be desired by the clinician to displace fluid, blood, debris and particulate matter from the field of view. This provides a better view of the underlying tissue or matter for assessment and therapy.
• fluid delivery system 16 includes a water-jet connector 18, water bottle connector 20, a suction connector 22 and an air pipe 24.
• Water-jet connector 18 is coupled to an internal water-jet lumen 28 that extends through handle 12 and elongate shaft 14 to the distal end of endoscope 10.
• water bottle connector 20, suction connector and 22 air pipe 24 are each connected to internal lumens 30, 32, 34 respectively, that pass through shaft 14 to the distal end of endoscope 10.
• Proximal handle 12 may include a variety of controls for the surgeon or clinician to operate fluid delivery system 16.
• handle 12 include a suction valve 34, and air/water valve 36 and a biopsy valve 38 for extracting tissue samples from the patient.
• Suction channel 34 extends from suction connector 22, where it creates a relatively tight turn or bend 22A through universal cord 15 into handle 12.
• Suction channel 34 then extends through shaft 14 to the distal end of endoscope 10.
• suction channel 34 passes biopsy valve 38, it creates an internal Y junction 38B with the channel 38C extending into biopsy valve 38. This Y junction 38b creates challenges for cleaning and/or drying suction channel 34 with conventional devices, as discussed in more detail below.
• Handle 12 may in certain embodiments also include an eyepiece (not shown) coupled to an image capture device (not shown), such as a lens and light transmitting system.
• image capture device as used herein also need not refer to devices that only have lenses or other light directing structure. Instead, for example, the image capture device could be any device that can capture and relay an image, including (i) relay lenses between the objective lens at the distal end of the scope and an eyepiece, (ii) fiber optics, (iii) charge coupled devices (CCD), (iv) complementary metal oxide semiconductor (CMOS) sensors.
• An image capture device may also be merely a chip for sensing light and generating electrical signals for communication corresponding to the sensed light or other technology for transmitting an image.
• endoscope 10 may further include a camera lens 62, a scope washer 32, and a light source 60 for providing a view of the surgical site in the patient, and a biopsy channel 50 for passing instruments therethrough.
• the biopsy channel 50 permits passage of instruments down the shaft 14 of endoscope 10 for removing tissue.
• Biopsy channel 50 may also function as a working channel for other instruments to pass through endoscope 10 for assessment and treatment of tissue and other matter.
• Such instruments may include cannulas, catheters, stents and stent delivery systems, papillotomes, wires, other imaging devices including mini-scopes, baskets, snares and other devices for use with a scope in a lumen.
• endoscope 10 may include a separate working channel for these instruments.
• FIG. 3 illustrates an internal lumen 70, such as a biopsy channel, working instrument channel or water/air channel, of a representative endoscope.
• lumen 70 includes numerous defects 72 that provide extremely small areas for harboring pathogens, biomatter, tissue or other debris therein. These defects 72 are very difficult to clean and dry with conventional devices.
• the biomatter protects the pathogens therein from conventional sterilization and disinfection techniques.
• the cleaning and/or drying device comprises an elongate shaft and a cleaning and/or drying member disposed on one portion of shaft.
• the cleaning and/or drying member may be removably attached to, or permanently affixed to, the shaft.
• the shaft may comprise any suitable material that provides sufficient rigidity for the shaft to be advanced through a lumen of an endoscope.
• the elongate shaft has an outer diameter sized to fit within, and translate through, the internal lumens in endoscope 10. In the exemplary embodiment, the shaft will have an outer diameter in the range of about 0.5 to about 5 mm, preferably about 1 to 4 mm.
• the device includes a pull cable configured to withdraw or advance elongate the shaft within an internal lumen in endoscope 10.
• Device may also include an energy source and a motor for advancing and/or withdrawing the elongate shaft.
• the elongate shaft may be manually translated through internal lumen via a proximal handle or suitable actuator (i.e., no motor).
• Cleaning and/or drying device 200 includes one or more cleaning and/or drying element(s) 300, which are attached to a pushing and pulling element, such as a navigation element 301 (only a portion of which is shown in FIG 4).
• Navigation element 301 can be advanced from the proximal end to the distal end (or vice versa) of any internal lumen with the endoscope.
• navigation element 301 is advanced from the scope’s biopsy channel to the distal end of the biopsy channel in order to exit from the biopsy channel and connect to a cleaning and/or drying element.
• Navigation element 301 may also be advanced from the proximal end of the scope’s biopsy channel to the distal end of the biopsy channel (or suction channel, as applicable) in order to exit from the biopsy channel and connect to a cleaning and/or drying element, or alternatively, advanced and pulled through the channel from the proximal end of the biopsy channel (or suction channel) to the distal end.
• This pushing and/or pulling navigation element is attachable and in embodiments also detachable, and in other embodiments may be permanently attached to cleaning and/or drying element 300.
• cleaning and/or drying element 300 is a separate element that is connectible to navigation element 301 such that navigation element 301 can be passed through an internal lumen of an endoscopic device.
• navigation element 301 can be advanced from the proximal entry to biopsy channel 38C down biopsy channel 38C, emit from the distal end of the biopsy channel and then connect to cleaning and/or drying element 300 so that the entire system can then be pulled from the distal end of the scope up the biopsy channel to then exit the proximal end of the biopsy channel.
• This approach allows the biopsy channel to be successfully cleaned without creating the problems with current technologies that accumulate debris and biomatter and push this out the distal end of the biopsy channel, resulting in additional contamination at the most difficult to clean part of the scope.
• This approach also allows for the successful drying of the biopsy channel.
• navigation element 301 and cleaning and/or drying element 300 are adhered to each other and advanced or retracted through one or more lumens together.
• Navigation element 301 and cleaning and/or drying element 300 may be manufactured as one integral device, or they may be manufactured separately and attached to each other prior to use.
• Channel element 300 comprises proximal and distal end portions, that are preferably at least two channel wall contact elements 302, 304, which are typically cylindrical in shape in order to match the shape of the endoscope’s channels.
• Wall contact element 302, 304 create a consistent circumferential contact with the interior wall of an endoscope channel, such as a biopsy or suction channel.
• channel element may include secondary wall contact elements 303, 305 (or additional ones if desired) to enhance the engagement between the wall contact elements and the internal lumen walls and to ensure that the variable pressure region (discussed below) is effective.
• Channel contact elements 302, 304 may comprise any suitable shape that substantially conforms to the walls of the internal lumen.
• channel contact elements 302, 304 preferably have a substantially circumferential, cylindrical or conical shape with at least one portion of the element 302, 304 having a diameter approximately equal to or slightly larger than the diameter of the internal lumen.
• the largest diameter of channel contact elements 302, 204 is about 1 to about 1.5 times the diameter of the internal lumen, preferably about 1 to about 1 .23 times this diameter.
• the largest diameter portion of elements 302, 304 may be about 4.2 to 5.5 mm, preferably about 5 mm. This additional size allows elements 302, 304 to deform slightly as they pass through the lumen, ensuring that they will remain in contact with the lumen.
• the contact elements are substantially conical such that they angle downwards in the proximal direction (or the direction of travel of the cleaning and/or drying device through the lumen of the endoscope), as shown in Fig. 4.
• This configuration allows contact elements 302, 304 to create a contact friction force along the internal walls of lumen so that they can slide along the walls of internal lumen of the endoscope without getting caught or otherwise stuck in the lumen, while still ensuring that at least a portion of contact elements 302, 304 remain in contact with the lumen.
• contact elements 302, 304 are about 0.75 mm and taper to about 0.5 mm at their tips (or the point of contact with the internal wall of the lumen).
• Cleaning and/or drying element 300 further includes a variable pressure region 306 between wall contact elements 302, 304.
• Variable pressure region 306 is designed to create variable pressure between the two circumferential contact elements 302, 304 and the wall of the channel being cleaned.
• cleaning fluid as required by scope manufacturers, which may be saline or any other biocompatible material safe to use with an in-dwelling catheter), the variable pressure design between the two circumferential elements creates either a vortex, a venturi effect, an inverted or reverse venturi effect or other variable pressure between the cleaning and/or drying element and the walls of the endoscope channel when the cleaning and/or drying element is moved through the lumen.
• variable pressure region 306 When used for drying a lumen, the forces created by the variable pressure region 306 increase the drying performance of element 300. These forces allows the cleaning and/or drying element to substantially remove all fluid and moisture from within the lumen.
• variable pressure region 306 may be designed to create areas of low pressure on either end of region 306 with an area of high pressure there between. In this embodiment, when the cleaning fluid or air flows across the variable pressure area, this impacts the fluid or air flow as it transfers from an area of low pressure across an area of high pressure and then back to another area of low pressure between the two cylindrical elements.
• variable pressure region 306 comprises a contraction section 308 coupled to the proximal contact element 302, a diffusion section 312 coupled to the distal contact element 304 and a throat section 310 coupling the diffusion and contraction sections 308, 310.
• the throat section 320 has a diameter less than the diameter of the contact elements 302, 204 and greater than a diameter of the diffusion and contraction sections 308, 310.
• This design enhances the performance of the cleaning fluid (or air) by turning the fluid (or air, as applicable) from a static point of interaction with the walls of a scope channel, to a dynamic point of interaction where the lifting action of the cleaning fluid’s chemistry (or air in the case of drying) is enhanced through cleaning and/or drying member’s direction of the fluid or air at the walls of the scope channel with pressure.
• Variable pressure region 306 may include an inverted, partial venturi shape, a parabolic shape, a variable slope shape or such other shape that creates variable pressure between the two cylinders and the wall of the channel being cleaned, thereby increasing the force by which the cleaning fluid or air is projected at the channel wall when the cleaning and/or drying member is advanced.
• throat section 310 is substantially cylindrical.
• the contraction section 308 preferably increases in diameter from the contact section 302 to the throat section 310 and the diffusion section 312 preferably decreases in diameter from the throat section 310 to contact section 304, thereby creating either a vortex, a venturi effect, an inverted or reverse venturi effect or other variable pressure between the distal and proximal end portions 302, 304 of the cleaning and/or drying element 310.
• variable pressure region 306 has an inverted, partial venturi shape with three distinct areas of various spacing from the wall of the scope channel, which creates accelerated hydrodynamic action or similar action with air to project the cleaning fluid (or air) at the channel wall to clean more effectively.
• These areas include a contraction section 308, which is the start of the area where cleaning fluid (or air) is present on the other side of the first cylindrical element.
• the contraction section 308 is the start of the area in which fluids accumulate and are subject to changing pressure as the space available for the fluid varies and becomes smaller as cleaning and/or drying element 300 is advanced and the fluids (or air) are directed into the throat section 310 that further alters the pressure between the cleaning and/or drying element and the channel wall.
• the throat section 310 wherein the shape available for the fluid is reduced further 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, creates an acceleration of the fluid as cleaning and/or air as the drying element 300 is advanced; followed by a diffusion section 312 which supports the diffusion of the cleaning fluid (or air) at an accelerated speed as it exits the throat section.
• these sections between the cylindrical elements create a hydrodynamic force for cleaning fluids sufficient to remove bacteria, biomatter and debris from the walls of the channels of the endoscope or a similar force with air to displace water and moisture to dry the channel of the endoscope. This hydrodynamic force applied to air is also sufficient to remove substantially all moisture and fluid from the lumens during a drying process.
• the angle of the slope of the contraction section 308 (defined as the angle made between the vertical section of conical section 302 and the sloped portion of contraction section 308) may vary depending on the diameter of the channel being cleaned, the viscosity of the fluid (or thickness of air) and other factors and should be sufficient to support a variable pressure flow of cleaning fluid or air between the cylinders when the cleaning and/or drying element is advanced.
• the contraction section defines an angle with the proximal end portion (i.e., contact section 302) that is about 4 degrees to about 85 degrees, preferably between about 15 degrees to about 30 degrees.
• the diffusion section defines an angle with the distal end portion (i.e., contact section 304) that is about 4 degrees to about 85 degrees, preferably about 15 degrees to about 30 degrees.
• various pressure regions 306 may have more than one slope, a curved shape, a variable shape or such other shape which assists in varying the pressure between the two cylindrical elements 302, 304.
• the angle between contraction and diffusion sections 308, 312 and throat section 310 may vary depending on the diameter of the channel being cleaned, the viscosity of the fluid or air and other factors, and should be sufficient to support a variable pressure flow of cleaning fluid or air between the cylinders when the cleaning and/or drying element is advanced. In certain embodiments, this angle is about 10 degrees to about 50 degrees, preferably about 15 degrees to about 30 degrees and more preferably about 20 degrees to about 25 degrees.
• each section of variable pressure region 306 are preferably selected to optimize either a vortex, a venturi effect, an inverted or reverse venturi effect or other variable pressure and will vary based on the diameter of the internal lumen, the viscosity of the fluid or air and other factors.
• the length of throat section 310 may be about 2 mm to 10 mm, preferably about 3 mm to 5 mm, and more preferably about 4 mm.
• the outer diameter of throat section 310 will also depend on the diameter of the inner lumen as well as the diameter of contraction and diffusion sections 308, 312.
• throat section 310 is less than the diameter of the internal lumen, but greater than 50% of the diameter of the lumen, preferably greater than about 60% of the diameter of the lumen, and more preferably equal to or greater than about 70% of the diameter of the lumen(e.g., about 3 mm in a lumen having an inner diameter of about 4.2 mm).
• the outer diameter of navigation element 301 is preferably less than the diameter of throat region 310. In an exemplary embodiment, this diameter is less than about 2.5 mm, preferably less than about 2.0 mm, and more preferably about 1.75 mm.
• variable pressure region 306 impacts the fluid flows (and air flows, as applicable) as it transfers from an area of high pressure across an area of low pressure between the two cylindrical elements, and then back to another area of high pressure, such that the cleaning fluid or air is directed at the channel walls with an increased force, similar to the venturi effect created when putting one’s thumb partially over the end of a garden hose to increase the force of the water emitting from the hose.
• This variable pressure design means that when cleaning and/or drying element 300 is attached and withdrawn or pulled with the navigation element through a scope channel, the cleaning fluid or air in the channel and between the cylindrical elements and the wall of the endoscope channel is moved across the variable pressure area between the two cylindrical spheres, creating a jetting of the cleaning fluid to pressure wash the channel walls of the endoscope channel with the cleaning fluid, or pressure of air to dry the channel walls.
• This unique capability has the powerful effect of enhancing the performance of the cleaning fluid by turning the fluid from a static point of interaction with the walls of a scope channel, to a dynamic point of interaction where the lifting action of the cleaning fluid’s chemistry is enhanced through the cleaning and/or drying element’s direction of the fluid (or air) at the walls of the scope channel with pressure.
• Computational modeling using fluid and pressure dynamics shows that, in embodiments, the application of inverted venturi principles to create variable pressure between two cylindrical elements directs the cleaning fluid (or air) at all of the channel wall with hydrodynamic (or air) pressures of variable and increasing force to create a new, highly effective cleaning and/or drying capability that can remove debris, biomatter and bacteria from the channel, or dry, including addressing changes in the surface topography of the channel due to the ability to direct the cleaning fluid with hydrodynamic force (or air) into any scratches and crevasses in the scope channel.
• Computational modeling and test data assessing the performance of the cleaning and/or drying element indicates this innovation impacts the direction and force of the cleaning fluid or air, changing the fluid from a static soaking detergent or air, into an active pressure washing and cleaning and/or drying modality where the cleaning and/or drying element’s variable pressure design creates a direct and beneficial fluid or air force against the wall of the channel.
• This pressure washing or air drying in the form of a directed, hydrodynamic fluid force or air against the channel walls, is a measurable force we call fluid or air friction force.
• this variable pressure region 306 causes the cleaning fluid or air to be projected at the channel wall with a pressure that exceeds the adhesion force of bacteria or moisture that may attach to the wall, creating a powerful benefit that is not present with existing brushing technologies.
• This capability enhances cleaning or drying, just as using a detergent with a pressure washer enhances the cleaning of an external surface, such as using a pressure washer with detergent to remove contaminants from the side of a building or a walkway, or an air dryer.
• variable pressure region 306 of cleaning/drying element 300 creates hydrodynamic/air pressure that directs cleaning detergent/air at the wall of the scope’s channels.
• the combination of cylindrical elements and a variable pressure element is important for creating the hydrodynamic or air force and it adds additional cleaning and/or drying force, by making atraumatic contact with the walls of the scope channel.
• These cylindrical elements add a channel wall contact pressure force as an additional cleaning or drying modality to remove debris and biomatter from the channel wall or to dry as an additional, complementary cleaning or drying capability that works in concert with the variable pressure element between the cylinders.
• variable pressure region of the cleaning element is configured to generate fluid or air pressure against the internal wall of the lumen.
• the variable pressure region is configured to generate a peak pressure of at least about 75 Pa in at least one area between the distal and proximal end portions of the cleaning element.
• This peak pressure is preferably at least 100 Pa and more preferably at least 125 Pa.
• the peak pressure may be approximately 150 Pa. This direct pressure against the lumen wall is sufficient to remove substantially all biomatter or moisture from the internal surface of the lumen.
• variable pressure region of the cleaning element is configured to generate an average or mean pressure across the distance between the proximal and distal end portions of the cleaning element of at least about 10 Pa, preferably about 20 Pa and more preferably about 30 Pa.
• the mean pressure is about 36 Pa.
• variable pressure region of the cleaning/drying element is also configured to generate a peak shear stress of at least about 4 Pa in at least one area between the distal and proximal end portions of the cleaning element, preferably at least about 5 Pa and more preferably at least about 8 Pa.
• the average or mean shear stress across the distance between the proximal and distal end portions of the cleaning element is at least about 1 Pa, preferably about 2 Pa and more preferably greater than 2.5 Pa. In an exemplary embodiment the mean shear stress is about 2.8 Pa.
• the variable pressure region of the cleaning/drying element is configured to generate a substantially high pressure across a relatively large coverage area between the proximal and distal ends of the cleaning element. This increases the amount of time that the inner surface of the lumen is subjected to this substantially high pressure, thereby increasing the amount of biomatter or moisture that can be removed with the device.
• Applicant has defined the Peak Cleaning Pressure Coverage Area (PPACTM) as the distance between the proximal and distal ends of the cleaning element in which the variable pressure region generates a pressure above 50 Pa.
• the cleaning/drying element is configured to generate a PPAC in at least about 10% of this distance, preferably at least about 25% of this distance and more preferably at least about 40% of this distance.
• variable pressure region of the cleaning/drying element is also configured to generate at least some positive pressure against the internal lumen across a relatively large coverage area between the proximal and distal ends of the cleaning element. This increases the amount of time that the inner surface of the lumen is subjected to at least some cleaning or drying pressure, thereby increasing the amount of biomatter or moisture that can be removed with the device.
• Applicant has defined the Positive Pressure Cleaning Area (+PACTM) as the distance between the proximal and distal ends of the cleaning element in which the variable pressure region generates a positive pressure (i.e., above zero).
• the cleaning/drying element is configured to generate a +PAC in at least about 25% of this distance, preferably at least about 50% of this distance and more preferably at least about 75% of this distance.
• the +PAC may be as high as 81 %.
• a ratio of contraction may be determined between the contraction section 308 and the throat section 310, though the ratio may change and vary depending on the diameter of the scope channel being cleaned, the durometer of the material used for cleaning element 300, the projected speed and force applied to withdraw the navigation element 301 after it is attached to cleaning element 300 or otherwise advanced through the channel, the viscosity of the fluid used for cleaning or air for drying, the desired fluid friction force of the cleaning fluid or air projected by cleaning element 300 and the direction of the flow exiting the throat section, including whether a narrow or broader flow is desired with the design.
• variable pressure region 306 will depend on a variety of factors, including but not limited to, the diameter of the lumen, the viscosity of the fluid or air within lumen, the specific shape and angles of contraction, 308, throat 310 and diffusion 312 sections and the like. In an exemplary embodiment, the length of variable pressure region is about 5 mm to about 20 mm, preferably about 10 mm.
• the angle of the surface of the diffusion section 312 may be a single plane or multiple planes. In embodiments the angle of the surface of the diffusion section 312 increases the space between the wall of the endoscope channel and cleaning element 300, in embodiments, in the diffusion section. This variation allows the fluid or air to accelerate at a higher pressure and velocity out of the throat section to create elevated and increasing fluid or air pressure force against the walls of the endoscope channel as cleaning element 300 is advanced through the endoscope channel.
• cleaning and/or drying element 300 may not have a three section arrangement and instead could have other shapes and forms intended to modify the pressures between the two cylinders and create elevated pressure sufficient to remove biomatter and debris from the walls of the scope’s channels or to dry the walls of the scope’s channels.
• the delivery of hydrodynamic force or air drying force covers a meaningful area of the scope’s channel between the two cylindrical elements, such that the application of the elevated force caused by cleaning element 300 is not narrow and instead involves elevated force that is broader and thereby has greater success at removing biomatter and debris, or drying.
• the hydrodynamic force exceeds the attachment force of bacteria commonly encountered in the medical procedures, or the adhesion force of moisture against the channel.
• FIGS. 5 and 6 illustrate the overall flow pattern of fluid or air flowing past cleaning/drying element 300 within an internal lumen of an endoscope device.
• the overall pressure distribution between cleaning/drying element 300 and the internal walls of the lumen creates a relatively low pressure region around contraction section 308, a higher pressure region around throat section 310 and even higher pressure region around diffusion section 312.
• the hydrodynamic or air force is directed at a force level greater than 10 Pa across at least 50% of the distance between the two cylindrical elements 302, 304.
• the hydrodynamic or air force is directed at a level greater than 10 Pa across at least 75% of the distance between the two cylindrical elements 302, 304.
• the force is greater than 20 Pa across at least 50% of the distance between elements 302, 304.
• FIGS. 5 and 6A also illustrate the peak pressure formed around diffusion section 312. As shown, the peak pressure can reach as high as 100 Pa or greater in this region. In certain embodiments, the pressure in the entire diffusion section 312 is greater than 50 Pa.
• the relative fluid or air velocity increases from one end of cleaning/drying element 300 to another as cleaning element 300 is advanced proximally (or distally depending on the direction of cleaning).
• diffusion section 312 creates swirling fluid or air (not shown) in diffusion section 312 that increases the pressure applied by the fluid or air to the internal walls of the lumen.
• FIG. 6B further illustrates the viscous shear stress created by cleaning/drying element 300 along the internal wall of the lumen as fluid passes between element 300 and internal wall.
• the shear stress is greater near cylindrical elements 302, 304.
• the peak shear stress is preferably greater than about 4 Pa and more preferably greater than 7 Pa. In an exemplary embodiment, the peak shear stress reaches about 8 Pa or higher.
• the average shear stress across the entire internal wall form element 302 to element 304 is preferably greater than about 1.5 Pa, and more preferably greater than 2.5 Pa (reaching almost 2.8 Pa in certain embodiments).
• the distance between the two cylindrical elements is any distance necessary to a variable pressure shape between the two cylindrical elements.
• the distance may be between 5 and 10 mm if the diameter of the scope channel being cleaned is between 4 mm and 4.5 mm.
• the distance may be a ratio relative to the diameter of the scope channel, such as less than 4:1 , less than 2:1 or less than 1.5:1 or other ratio (distance: diameter of scope channel).
• the diameter of the cylindrical elements may be designed to avoid deflection of proximal and distal end portions 302, 304. Deflection of these cylindrical elements can create a gap due to buckling that results in less than idea cleaning or drying results. This is one of the issues with pull thru cleaners, which are as large as 5.2 mm in diameter, but are applied in channels ranging in size from 2.8 mm to 5.0 mm in diameter and which must buckle to advance through the channel.
• the diameter of the cylindrical elements are between 1.0 and 1.23 times the diameter of the channel being cleaned or dried to keep the cleaning/drying device 200 centered in the channel being cleaned, with minimal to limited deflection of the ends of the cylindrical elements. Additionally, a deflection equation may be used to obtain the optimal cylindrical elements.
• the cylindrical elements are too high in diameter relative to the channel size, this can result in ineffective cleaning or drying due to gaps in the cylinders, deflection of the cleaning/drying device, too much resistance to pull the cleaning/drying device 200 consistently through the channel, among other issues.
• the materials selected can also impact this result.
• the material has a durometer between 35 and 70 shore A, depending on the cylinder size and design, though different durometers and multiple durometers in the same device may be used.
• the dimensions of cleaning/drying device 200 may allow for the advancement of the cleaner from the distal end without being caught on the elevator of duodenoscopes or endoscopic ultrasound scopes, which is an issue with current bristle brushes and pull through cleaners, though the dimensions of the cleaning/drying device 200 may also allow for passing through the scope channel in the opposite direction, from proximal to distal.
• the cleaning and/or drying device 200 may have one or more absorbent sponges placed in front of or at the end of cleaning and/or drying element 300 or in between one or more of the cylindrical elements to absorb biomatter and debris and fluid.
• the absorbent sponges may be of a single cell configuration or have multiple sponges with different cell configurations to provide scrubbing, absorption, lifting, diffusion of cleaning fluid, or a combination of these attributes.
• the absorbent sponges may be of any material, including polyurethane, polyvinyl alcohol, or other absorbent material.
• the sponges are soft and atraumatic when immersed in fluid, and expand to a size that is at least the size of the channel being cleaned, and in a preferred embodiment is larger than the channel being cleaned.
• the sponges may be any shape that conforms and aids in cleaning and/or drying the scope’s channel, including by way of example, not limitation, cylindrical in shape, spiral in shape, conical, triangular, square or any combination thereof.
• the sponge(s) will have a pore size of between about 200 to 1500 PPC, preferably between about 200 PPC and about 600 PPC.
• cleaning/drying device 200 may include a brush of various designs which contacts a portion of the channel wall in addition to the other aspects of cleaning/drying element 300.
• the brush may be of a length that is in the ration of 1 .0 to 1 .4 times the diameter of the channel to be cleaned or dried.
• the brush is preferably made of an atraumatic polymer, such as polyurethane, with a thickness and durometer designed to limit trauma and injury to the channel wall, while maintaining sufficient rigidity to remove contamination or moisture from the walls of the channel.
• the diameter of the brush elements contacting the channel wall may be any diameter, but in embodiments may be between .5 and 2 mm.
• the brush elements may be perpendicular to the navigation element and in embodiments, may be part of a separate, shorter navigation element designed to reach only a few a limited distance into the biopsy channel.
• This shorter version may be any length appropriate for cleaning or drying the initial entry points into the biopsy channel, but in a preferred embodiment is between 4.5 and 15 cm long.
• This brushing element, whether part of the cleaning element or in a separate shorter version may also utilize nylon wire bristles or other bristles if arranged in a pattern that is effective in cleaning or drying and minimizes trauma to the scope channel.
• a grip element of the brush may have a shape at one end or in the center of the element that is larger to facilitate introduction into the biopsy channel.
• Cleaning device 400 may be designed to capture a certain volume of debris relative to the dimensions and level of contamination of the channel being cleaned or a certain level of moisture with drying.
• additional cylinders and variable pressure elements may be added increasing the length of cleaning device 400 to capture and remove more contamination or moisture.
• a sponge or sponges of various pore size, diameter and length may be added to increase the removal of contaminants or moisture.
• each cleaning and/or drying element 300 includes proximal and distal end portions and a variable pressure region therebetween, as described above.
• the proximal and distal end portions are preferably cylindrical elements having an outer diameter substantially the same as the inner diameter of the lumen to be cleaned (as discussed in detail below).
• the cleaning and/or drying elements are coupled to each other at the proximal and distal end portions.
• the proximal end portion of one cleaning and/or drying element is integral with the distal end portion of the next cleaning and/or drying element, although it will be recognized that other configurations are possible.
• the cleaning and/or drying device may further include a centering element 424 on either or both of the proximal and distal end portions of the cleaning and/or drying device.
• Centering element(s) 424 serve to center navigation element 301 and the cleaning and/or drying device as the device is pulled or pushed through lumens around turns and navigates through corners and other complex areas, including junctions of multiple lumens and internal channels in the scope or other instrument being cleaned.
• Centering element(s) 424 may be smaller than the diameter of the lumen through which the device is being advanced, but have a significant enough size to prevent misalignment and deflection of the navigation element 301 to one side or another of the lumen as it navigates, including as the cleaning and/or drying device as it is pulled or pushed around curves, corners and junctions of various lumens (including Y junctions).
• Centering element(s) 424 may be any shape that keeps the device generally centered and prevents this deflection, with a preferred embodiment being a cylindrical shape with a tapered distal end.
• centering element (424) may comprise a series of shaped elements projecting from the elongate member or the navigation member.
• This series of shaped elements may, for example, comprise struts, spikes, or other projections extending radially outward from the elongate member and sized to substantially center the elongate member and/or the drying/cleaning elements within the internal channel of the endoscopic device.
• device 800 further includes a proximal tip element 802 and a proximal cylindrical centering element 804 disposed around variable pressure region 306.
• Element 804 is preferably disposed around the contraction section 308 of pressure region 306 between the diffusion section 312 and the throat section 310 (see FIG. 4 and the above description of these elements).
• Cleaning and/or drying device 910 includes two additional cylindrical or annular elements 402, 404 at a distal end of the device 910.
• cylindrical/annular elements 402, 404 may be any shape that keeps the device generally centered and prevents this deflection, with a preferred embodiment being a cylindrical shape with a tapered distal end.
• the system may further include a guidance element (750 in FIG. 25 and 760 in FIG. 26) to aid in passing the cleaning and/or drying device 200 through certain difficult areas of the endoscope.
• the guidance element inhibits the navigation element from deflecting into the wrong channel when passing an internal junction between multiple channels, such as Y junction 38B between suction channel 22 and biopsy channel 38C.
• the guidance device may be used to navigate the cleaning and/or drying device through tight turns or bends in endoscopic lumens.
• the guidance element 750 or 760 may be inserted into one of the scope’s internal channels, such as biopsy channel 38C or suction channel 22, in order to aid in passing cleaning and/or drying device 200 from the distal end of scope 10 to the proximal end of biopsy channel 38C or suction channel 22 to facilitate cleaning and/or drying in a manner where the debris is pulled away from the complex, hard-to-clean distal end of the scope in a distal to proximal motion.
• guidance element 750 comprises a hollow tube, such as a tubular sheath or the like, that may be temporarily inserted in the desired branch of an internal junction between two channels, such that a portion of cleaning and/or drying device 200 enters into, or engages with, guidance element 750 as it is advanced through the channel and deflects or passes into guidance element 750 to avoid advancing cleaning and/or drying device 200 into an unintended side of a junction or intersection of internal channels.
• guidance element 750 may be inserted from the entry point to the biopsy channel 38C past the Y junction 38B, so that the navigation element of cleaning and/or drying device 200 enters into, or engages with, the guidance element and emits at the end of the biopsy channel 38C, rather than deflecting at Y junction 38B and advancing toward suction portion of the endoscope [see, for example, the suction valve 36 in FIG. 1]-
• Guidance element 750 may also be used to assist, if needed, with advancing cleaning and/or drying device 200 around a tight internal turn in the internal channel of the endoscope, such as the exit of the channel 22 in FIG. 1 and for other assistance, if needed, with advancing the navigation or the cleaning and/or drying element.
• guidance element 750 is tubular or cylindrical with an outer diameter smaller than an inner diameter of the internal lumen (e.g., the biopsy channel 38) and an inner lumen having a diameter that is at least larger than the diameter of the navigation element of cleaning and/or drying device 200.
• guidance element 750 is of a shape that conforms as closely as possible to the diameter of the scope channel leading up to internal Y junction 38B or other internal areas of scope 10, with a length that reaches or extends past the junction 38B, which, in embodiments, can be between 8 and 20 cm.
• the outer diameter of the guidance element would be between 3.5 mm and 4.15 mm and the inner diameter would be between 1 .5 mm and 4.05 mm.
• guidance element 750 may comprise an angled tip to further conform to the shape of a multi-channel internal junction in the scope.
• the proximal end of guidance element 750 may have a flange that is larger than the entry opening to the specific scope channel where the navigation element is inserted, so that the navigation element cannot be advanced entirely into the channel and result in difficult withdrawal.
• guidance element 750 may not have a flange, but may have a marker, including for example, a pad printed or other line, demarcating the maximum recommended point of advancement of the navigation element into the scope channel.
• FIG. 26 illustrates another embodiment of a guidance element 760 that comprises a substantially circular rod having an angle distal tip so that the elongate navigation member 301 can be passed from the distal end of the scope to the suction valve opening while deflecting up into the biopsy channel 38C at the Y junction 38B.
• the proximal end of guidance element 760 may have a flange that is larger than the entry opening to the specific scope channel where the navigation element is inserted, so that the navigation element cannot be advanced entirely into the channel and result in difficult withdrawal. It may also include an angle cut at its distal end to further conform to the shape of a multi-channel internal junction in the scope.
• FIG. 10 illustrates another embodiment of a cleaning and/or drying device 500 with multiple cleaning and/or drying elements 502a, 502b coupled to a navigation element 504.
• cleaning and/or drying elements 502a, 502b each include cylindrical wall contact portions 506 and a variable pressure central portion 508.
• each central portion 508 of cleaning and/or drying elements 502a, 502b includes at least one contraction portion 510 that angles downwards and then a throat portion 512 that angles upwards again 512 towards the luminal wall.
• cleaning and/or drying element 502a includes an additional portion 514 that also includes a contraction and throat portion, forming two separate variable pressure elements within a single cleaning and/or drying element 502a.
• Cleaning and/or drying element 502b only includes one variable pressure region, although it will be understood that various combinations of these features may be included.
• cleaning and/or drying device 500 may include multiple cleaning and/or drying elements that each include multiple variable pressure regions.
• each of the cleaning and/or drying elements may only include one variable pressure region as shown with respect to cleaning and/or drying element 502b.
• the combination of these sections creates variable pressure that induces high shear stress against the walls on the lumen.
• FIGS. 11A-11D illustrates other configurations for the variable pressure region of the cleaning and/or drying element.
• a cleaning and/or drying element 560 comprises a contraction section 562 with a larger angle between section 562 and the throat 566 than the angle between throat section 566 and diffusion section 564.
• FIG. 11 B illustrates a cleaning and/or drying element 570 that does not include a specific throat section.
• a cleaning and/or drying element 570 includes a contraction section 572 that immediately forms into the diffusion section 574 (i.e., angles towards the inner lumen and then angles back inwardly without a central cylindrical throat section).
• FIGS. 11C and 11 D illustrate cleaning and/or drying elements 550 that create multiple high-pressure regions by comprising more than one throat section 552.
• the series of cleaning and/or drying elements may each have different configurations. As shown, in some instances, a cleaning and/or drying element with a single throat section can be followed by one with multiple throat sections or vice versa.
• FIG. 12 illustrates yet another embodiment of a cleaning and/or drying device 600 that includes a cleaning and/or drying element 602 and a navigation element 604.
• navigation element 604 includes an infusion lumen 608 for delivering air or additional fluid to cleaning and/or drying element 602.
• Cleaning and/or drying element 602 includes one or more infusion ports 606 for delivering the air and/or fluid into the variable pressure region within the lumen created by cleaning and/or drying element 602. Delivering fluid into the variable pressure region increases the pressure therein, which thereby increases the fluid or air forces against the internal wall of the lumen to be cleaned.
• Cleaning and/or drying device 400 may be non-sterile, disinfected or sterilized using an appropriate sterilization method, including e-beam, gamma, eto gas, hydrogen peroxide, steam or the like. In the event that the device 400 is used for drying, it will typically be sterilized.
• the materials for navigation element 301 can be any material sufficient to navigate through the channel being cleaned and able to manage the pull force associated with advancing the cleaning and/or drying element 300 through the channel being cleaned.
• navigation element 301 is a monofilament composed of nylon, polyamide, polyurethane, PET or other polymeric material, with a diameter of at least 1 mm.
• Navigation element 301 may include a grip element at one end that facilitates holding and passing navigation element 301. In embodiments, this grip element is larger than the entry point to the biopsy channel to protect against over advancing navigation element 301 into the biopsy channel and losing one’s grip on navigation element 301.
• navigation element 301 comprises one or more internal channels that allow for cleaning fluid or air to be infused down navigation element 301 to one or more ports and also allow for suctioning fluid if desired.
• An infusion port may be present in cleaning/drying device 300 to emit the fluid or air advanced through navigation element 301 , allowing cleaning fluid or air to be infused through navigation element 302 into cleaning device 200 to further modify and increase the hydrodynamic pressure of the cleaning fluid against the channel wall.
• navigation element 301 and cleaning element 302 may also contain one or more suction channels which may be used to more rapidly circulate the cleaning fluid or air, and/or to flush the fluid and extract debris and fluid or moisture through the suction channel.
• navigation element 301 is attachable to the cleaning and/or drying element 300 through permanent attachment, which can be through molding, overmolding, two shot molding, glue or other means to create an attachment between the navigation and cleaning and/or drying elements where the two elements are fixed or affixed for use.
• navigation element 301 is separately attachable and in certain embodiments attachable and detachable, so that navigation element 301 may be attached from one end of a channel the other end, exit the channel and then be attached to cleaning and/or drying element 300.
• the means of attachment is any way suitable for the intended use, which by way of example may include interlocking elements, compression fitting, a slide and locking mechanism, a loop and a hook mechanism, an insert and twist mechanism or variations and alternative combinations suitable for the diameter and shape of the navigation and cleaning and/or drying elements.
• FIGS. 13-15 illustrate three different embodiments for removably attaching a shaft 400, such as a navigation element to a cleaning and/or drying element 402.
• cleaning and/or drying element 402 may include a recess 404 for receiving a protruding section 406 of shaft 400.
• shaft 400 may include one or more barbs 410 that fit within openings 412 of cleaning and/or drying element 402.
• Shaft 400 may include a flexible section 414 to allow barbs to 410 to fit within an internal lumen of cleaning and/or drying member 402.
• shaft 400 may include one or more projections 420 that can be rotated into grooves on cleaning and/or drying member 402 to attach the cleaning and/or drying member to the shaft.
• projections 420 can be rotated into grooves on cleaning and/or drying member 402 to attach the cleaning and/or drying member to the shaft.
• other methods for coupling shaft 400 to cleaning and/or drying element 402 include, but are not limited to flattened monofilaments, wires, strings or filaments coupled to releasable or non-releasable knots, crimps, press-fit elements, projections engaging with holes, channels or other openings, heat staking, heat bending, heat piercing, hooks, snap-fit elements and the like.
• navigation element 301 is advanced through a lumen of an endoscopic instrument, such as a biopsy channel 50 of an endoscope 10.
• the lumen is filled, or partially filled, with a fluid, such as an enzymatic detergent, or other cleaning fluid.
• the fluid functions to initially clean and/or disinfect the lumen to remove at least some of the biomatter and other pathogens from the lumen.
• navigation element 301 is withdrawn back through the lumen of the instrument.
• device 200 includes a pull cable configured to withdraw or advance elongate shaft 301 within an internal lumen in endoscope 10.
• Device may also include an energy source and a motor for advancing and/or withdrawing navigation element 301 .
• navigation element 301 may be manually translated through internal lumen via a proximal handle or suitable actuator (i.e., no motor).
• each cleaning and/or drying element 300 creates its own variable pressure region between proximal and distal ends 302, 304.
• variable pressure regions 306 increase the relative velocity between the fluid within each cleaning and/or drying element 300 and the walls of cleaning and/or drying element 300, which causes the fluid to accelerate relative to the internal walls of the lumen, thereby creating more fluid force against the walls (as discussed in more detail above). This increased fluid force provides a more effective cleaning and/or drying than conventional devices.
• Navigation element 301 may be withdrawn through lumen either manually or via a motor, as described above.
• navigation element 301 is withdrawn at a predetermined speed, such as about 20-50 cm/sec, preferably about 30 cm/sec. Applicant has discovered that withdrawal at this velocity optimizes the effects of pressure variable regions 306 on the fluid within cleaning and/or drying elements 300.
• Navigation element 301 may be withdrawn only once, or it may be advanced again, and withdrawn a second or third time, depending on the particular cleaning and/or drying requirements. In certain embodiments, 301 is only withdrawn partially through the lumen before it is advanced again so that the cleaning and/or drying elements do not push biomatter and other debris from the proximal portion of the scope (i.e., biopsy channel) back into the lumen.
• proximal portion of the scope i.e., biopsy channel
• kits are also provided for use in cleaning and/or drying an endoscopic instrument.
• the kit includes any of the cleaning and/or drying devices described above and may include an endoscope instrument or an endoscope, such as any of the endoscopes described above in reference to Fig. 1 , or others known by those skilled in the art.
• the kit may include a variety of other devices used for cleaning and/or drying procedures in any combination, such as cleaning brushes, swabs and/or sponges, enzymatic cleaners, disinfectants, and other devices and agents for sterilizing and/or disinfecting medical devices, scope drying agents, test strips or other sensors for determining the effectiveness of such cleaning and/or drying devices (i.e., detecting the presence of proteins, biomatter, bacteria, fungi, viruses, protein, ATP or bacteria markers, or other pathogens), personal protective equipment (PPE), scope housings for transporting scopes to and from, for example a reprocessing location, contamination bags and the like.
• Another kit provided herein includes a cleaning device and a drying device.
• both the cleaning and drying devices may comprise one or more of the embodiments described above.
• the kit may include a non-sterilized cleaning device and a sterilized drying device.
• the kit may include one device that functions to both clean and dry an internal lumen of an endoscopic device.
• a cleaning device may be one color and a drying device may be a different color in order for users to easily determine the purpose of each device. This aids in identifying the use of each device and it aids in making clear which device is sterilized after it is opened.
• the color difference may be the navigation element, the cleaning/drying element, a pad print line, or other marker to make clear the different uses of each device.
• the kit includes a cleaning device such as one the embodiments described above and a drying device that comprises an advancement element that may be a filament, wire, tube or other element capable of advancement into an internal channel, including a long, curved, or other channel that is difficult to access because it is recessed or internal.
• an advancement element that may be a filament, wire, tube or other element capable of advancement into an internal channel, including a long, curved, or other channel that is difficult to access because it is recessed or internal.
• this element can be grasped at an end once it is pulled through the internal channel and then pulled through the channel as part of the drying process. It also can be advanced from the other end through pushing the advancement element.
• This element may include a version that is able to advance air through the device and into the channel, including to a removed location well inside the channel and beyond the typical effectiveness of forced air drying in a channel.
• the drying member may comprise one or more substantially cylindrical members spaced from each other along the advancement member.
• the cylindrical members are configured to maintain contact with the channel wall to displace and remove any moisture as the advancement element travels through the channel.
• the advancement element may be advanced through being pushed, pulled or by other means, including back and forth agitation, advancement and withdrawal based on a pattern.
• the advancement element may travel through the scope by connection to an automated or mechanized approach or any other means of moving the channel drying element through the channel to displace, absorb and or remove water at least in part through direct contact with the surface area to be dried.
• the drying member may comprise a series of one or more cylindrical squeegees that are designed to make wall contact with the internal walls of the channel to remove fluid and moisture from the channel.
• These cylindrical squeegees may be arranged in any manner that is effective at removing fluid and moisture from the channel.
• the spacing between squeegees and any other elements, including drying elements may be any spacing that supports rapid and predictable channel drying, including a spacing of 1 mm, 1.25 mm, 1.5 mm, 2 mm, close spacing of 1.25 mm and then a 4 mm gap and then spacing of 1 .25 to 1 .5 mm or other spacing closer or farther or more variable that optimizes and supports rapid and predictable channel drying. Spacing, diameters and alignment and grouping of drying elements may vary based on channel size, channel material, the number of curves to navigate around, the number of junctions with other channels, if any, the channel dryer material, and other factors specific to the given channel drying application, in embodiments.
• the Positive Pressure Cleaning Area (“+PACTM”) is defined as the distance along a cleaning I drying element wherein the cleaning fluid or air pressure against the internal wall of the lumen is positive or above zero.
• the Pull ThruTM Cleaner 700 had a +PAC of about 0.52 mm or 13.5% of the total distance between ends 702, 704.
• the cleaning device 200 disclosed herein had a +PAC of about 7.54 mm or about 81% of the length between cylindrical elements 302, 304.
• the vast majority of the area between cleaning/drying device 200 and the internal luminal wall had a positive cleaning pressure.
• device 100 includes a pull cable configured to withdraw or advance elongate shaft 102 within an internal lumen in endoscope 10.
• Device may also include an energy source and a motor for advancing and/or withdrawing elongate shaft 102.
• elongate shaft 102 may be manually translated through internal lumen via a proximal handle or suitable actuator (i.e., no motor).
• Cleaning/drying member 104 may be expanded through a variety of different means known to those skilled in the art.
• cleaning member 104 is configured to expand upon absorption of a fluid.
• cleaning member 104 may be advanced into the lumen in a relatively dry state, and then allowed to absorb fluid therein, such that cleaning/drying member 104 expands to a diameter equal to, or greater than, the inner diameter of the lumen.

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