Modulated cleaning fluid flow

Abstract

Presented herein are techniques for directing a flow of a cleaning fluid along a fluid path that includes a lumen and modulating the flow of the cleaning fluid at one or more locations of the fluid path and / or controlling the impact of the flow of the cleaning fluid at the one or more locations of the fluid path.

Description

MODUEATED CLEANING FLUID FLOWBACKGROUNDField of the Invention[oooi] The present invention generally relates to techniques for cleaning interior lumens of, for example, medical devices such as endoscopes.Related Art

[0002] There are several different types of systems / devices that include interior conduits / lumens that can need cleaning. The lumens can include, for example, dental lines, food / drink lines, medical lumens, etc.

[0003] A number of different medical devices (medical instruments), in particular, can include interior lumens that can be used to perform diagnostic and / or surgical procedures. For example, an endoscope is a medical device that includes interior lumens that can be used to visually inspect hollow organs or body cavities, deliver / extract fluids, etc. Specially designed endoscopes are used for different examinations, such as bronchoscopy, cystoscopy, gastroscopy, and proctoscopy. Endoscopes, as well as other available diagnostic and / or surgical medical devices are re-useable across multiple patients and, as such, the interior lumens must be cleaned between uses.SUMMARY

[0004] In one aspect, a method is provided herein. The method includes directing a cleaning fluid flow along a fluid path that includes at least one lumen; and modulating the cleaning fluid flow at one or more locations in the fluid path to control an impact of the cleaning fluid flow on at least one target structure.

[0005] In another aspect, an apparatus is provided herein. The apparatus includes a body configured to couple to an endoscope; a cover member extending from the body and configured to align with a target structure of the endoscope to cover the target structure; and an opening formed into the body and configured to allow cleaning fluid flow out of the endoscope and through the body.BRIEF DESCRIPTION OF THE DRAWING

[0006] Embodiments of the present invention are described herein in conjunction with the accompanying drawings, in which:

[0007] FIG. 1 is a schematic diagram illustrating an endoscope with interior lumens that can be cleaned in association with certain embodiments presented herein.

[0008] FIG. 2A is a flowchart of an example method for cleaning an interior lumen of a medical device using liquid-powder mixtures, in accordance with certain embodiments of the present invention.

[0009] FIG. 2B is a schematic diagram illustrating one stage / phase of a process for cleaning a lumen, in accordance with certain embodiments of the present invention.[ooio] FIG. 2C is a schematic diagram illustrating another stage / phase of a process for cleaning a lumen, in accordance with certain embodiments of the present invention.[ooii] FIG. 3 is a perspective view illustrating a distal end of the endoscope of FIG. 1;

[0012] FIG. 4 is a perspective view illustrating the distal end of the endoscope of FIG. 1 with an adhesive member, in accordance with certain embodiments presented herein;

[0013] FIG. 5A, FIG. 5B, and FIG. 5C are each a perspective view of a mechanical cap attached to the distal end of the endoscope of FIG. 1, in accordance with certain embodiments presented herein;

[0014] FIGs. 6A, FIG. 6B, FIG. 6C, FIG. 6D, and FIG. 6E are each a perspective view illustrating another mechanical cap attached to the distal end of the endoscope of FIG. 1, in accordance with certain embodiments presented herein;

[0015] FIG. 7 is a cross-sectional view illustrating a brush diffuser disposed at the distal end of the endoscope of FIG. 1, in accordance with certain embodiments presented herein;

[0016] FIG. 8 is a schematic diagram illustrating the use of an intercepting fluid flow, in accordance with certain embodiments presented herein;

[0017] FIG. 9 is a schematic diagram illustrating delivery of a cleaning fluid flow via the distal end of the endoscope of FIG. 1, in accordance with certain embodiments presented herein;

[0018] FIG. 10A and 10B are schematic diagrams illustrating delivery of a cleaning fluid flow via an air / water cylinder of the endoscope of FIG. 1, in accordance with certain embodiments presented herein.

[0019] FIG. 11A and 1 IB are schematic diagrams illustrating delivery of a cleaning fluid flow via an air / water cylinder of the endoscope of FIG. 1, in accordance with certain embodiments presented herein.

[0020] FIG. 12 is a flowchart illustrating a method for directing a cleaning fluid flow, in accordance with certain embodiments presented herein.DETAILED DESCRIPTION

[0021] As noted, there are a number of different types of systems / devices that include interior conduits / lumens, such as dental lines, food / drink lines, medical lumens, etc., that may need periodic and / or regular cleaning. There are also a number of different techniques that perform this lumen cleaning by passing some form of cleaning fluid through the lumen. For example, co-owned International Patent Publication No. WO2022256871A1, the content of which is hereby incorporated by reference herein, describes a lumen cleaning system in which a cleaning fluid in the form of fluidic contaminant-detaching composition is passed through the lumens.

[0022] The present inventors have discovered that, in certain cases, it may be beneficial to “modulate” (e.g., exert a modifying or controlling influence on, such as to reduce the force of, re-direct, etc.) the flow of a cleaning fluid at one or more locations, such as, the distal end, of certain lumens; relatedly, it may be beneficial to apply a different / altemative fluid regime / paradigm to modulate / control the impact on one or more locations of a target lumen. In certain embodiments, the flow of a cleaning fluid is modulated at one or more locations of a lumen by reducing the amount of physical interaction between the cleaning fluid and the lumen (e.g., using a relatively lower amount of a powder in a liquid-powder mixture, reducing the velocity of the cleaning fluid, using cleaning solutions with different physical properties, etc.). In other embodiments, the flow of a cleaning fluid is modulated at one or more locations of a lumen through the use of a solid structure adjacent the distal end to at least one of direct / re- direct the cleaning fluid in / to a selected direction or to physically shield one or more other elements from the cleaning fluid. In still other examples, the flow of a cleaning fluid is modulated at the one or more locations of a lumen by de-energizing the cleaning fluid. Theseexample types of cleaning fluid modulation are illustrative and, as detailed below, other cleaning / flushing paradigms can be used to modulate / control the impact of a cleaning fluid at the one or more locations of a lumen.

[0023] Modulating the flow of the cleaning fluid can help control an impact of the cleaning fluid on a target structure while still providing sufficient cleaning benefits for the lumen. For instance, modulating the flow of the cleaning fluid can reduce an impingement or a force of the cleaning fluid against the target structure (e.g., to maintain a structural integrity, a placement, and / or operation of the target structure). Thus, modulating the flow of the cleaning fluid can allow the cleaning fluid to clean the lumen effectively while having a gentler or reduced impact on the target structure.

[0024] For ease of description, the techniques presented herein are primarily described with reference to cleaning specific medical lumens, namely the interior lumens of an endoscope. However, it is to be appreciated that the techniques presented herein can also or alternatively be used to clean any type of interior lumen. Before describing the techniques of the present disclosure, a description of an endoscope and one example type of endoscope cleaning is first provided below.

[0025] An endoscope is an elongate tubular medical device that may be rigid or flexible and which incorporates an optical or video system and light source. Typically, an endoscope is configured so that one end can be inserted into the body of a patient via a surgical incision or via one of the natural openings of the body. Internal structures near the inserted end of the endoscope can thus be viewed by an external observer.

[0026] As well as being used for investigation, endoscopes are also used to carry out diagnostic and surgical procedures. Endoscopic procedures are increasingly popular as they are minimally invasive in nature and provide a better patient outcome (through reduced healing time and exposure to infection), enabling hospitals and clinics to achieve higher patient turnover.

[0027] FIG. 1 is a schematic diagram of an example endoscope 100 with which aspects of the techniques presented herein can be implemented. As shown, endoscope 100, similar to most endoscopes, has a long tube-like structure with a distal end (distal tip) 102 at one end for insertion into a patient and an opposing proximal or connector end 104, with a control handle 106 located between the two ends (e.g., generally at the center of the length between connector end 104 and distal end / tip 102). The connector end 104 includes a plurality of connectors that enable the endoscope to be attached to, for example, a light source 108, water source 110, asuction source (not shown in FIG. 1), and a pressurized air source 112. For example, shown in FIG. 1, is a suction port / connector 137, a water-jet (auxiliary) port / connector 139, a water port / connector 141, and an air-port / connector 143. The control handle 106 is held by the operator during the procedure to control the endoscope 100 via valves, which include in this example a suction valve 114, an air / water cylinder (valve) 116, and a biopsy valve 118, and control wheels 120.

[0028] As shown in FIG. 1 , endoscope 100 includes internal channels used either for delivering air and / or water, providing suction or allowing access for forceps and other medical equipment required during the procedure. As such, the distal tip 102 contains the camera lens (not shown in FIG. 1), and the exits for the lighting, air, and water, as well as exits for suction and forceps. Some of the internal channels run from one end of the endoscope 100 to the other, while others run via valve sockets at the control handle. Some channels bifurcate while and others join from two into one.

[0029] More specifically, shown in FIG. 1 is a biopsy / suction channel 122, an air channel 124, a water channel 126, and a water-jet channel 128. The biopsy / suction channel 122 includes two sections, referred to as proximal section 122A and distal section 122B that are connected via the suction valve 114. The air channel 124 also includes two sections, referred to as proximal section 124A and distal section 124B that are connected via the air / water cylinder (valve) 116. Similarly, the water channel 126 also includes two sections, referred to as proximal section 126A and distal section 126B that are connected via the air / water cylinder 116. The distal section 126B of the water channel joins to the distal section 124B of the air channel at a location 130 within the distal section 133 of the endoscope and each exit via nozzle 149. The water-jet channel 128 extends directly from the connector end 104 to the distal end 102 (via the control handle 106) but is similarly referred to as having a proximal section 128A and distal section 128B. The proximal sections 122A, 124A, 126A, and 128A of the channels are sometimes referred to as being located within a universal cord section (cord) 132 of the endoscope 100, while the distal sections 122B, 124B, 126B, and 128B of the channels are sometimes referred to as being located within an insertion tube 134 of the endoscope. More generally, as used herein, the proximal sections 122A, 124A, 126A, and 128A are the portions of the channels located between the connector end 104 and a valve (e.g., valve 114 or 116) at the control handle 106 and / or a mid-point of the control handle 106, as applicable. The distal sections 122B, 124B, 126B, and 128B are the portions of the channels located between the valve (e.g., valve 114 or116) at the control handle 106 and / or a mid-point of the control handle 106, and the distal end 102 of the endoscope 100.

[0030] The high cost of endoscopes means they must be re-used. As a result, because of the need to avoid cross infection from one patient to the next, each endoscope must be thoroughly cleaned and disinfected or sterilized after each use. This involves the cleaning of not only the outer of the endoscope 100, but also cleaning and disinfecting the internal channels / lumens (e.g., lumens 122, 124, 126, and 128 of FIG. 1).

[0031] Endoscopes used for colonoscopic procedures are typically between 2.5 and 4 meters long and have one or more lumen channels of diameter of no more than a few millimeters. Ensuring that such long narrow channels are properly cleaned and disinfected between patients presents a considerable challenge. The challenge of cleaning is also made more difficult by the fact that there is not just one configuration / type of endoscope. Indeed, there are a variety of endoscopic devices, each suited to a particular insertion application, such as colonoscopes inserted into the colon, bronchoscopes inserted into the airways, gastroscopes for investigation of the stomach, etc. Gastroscopes, for instance, are smaller in diameter than colonoscopes; bronchoscopes are smaller again and shorter in length while duodenoscopes have a different tip design to access the bile duct.

[0032] A variety of options are available to mechanically remove biological residues from the lumen which is the first stage in the cleaning and disinfection process. One procedure for cleaning the lumens utilizes small brushes mounted on long, thin, flexible lines. Brushing is the mandated means of cleaning the lumen in some countries. These brushes are fed into the lumens while the endoscope is submerged in warm water and a cleaning solution. The brushes are then pushed / pulled through the length of the lumens in an effort to scrub off the soil / bio burden. Manual back and forth scrubbing is typically required. Water and cleaning solutions are then flushed down the lumens. These flush-brush processes are repeated three times or until the endoscope reprocessing technician is satisfied that the lumen is clean. At the end of this cleaning process air is pumped down the lumens to dry them. A flexible pull-through device having wiping blades may also be used to physically remove material. A liquid flow through the lumen at limited pressure can also be used.

[0033] In general, however, only the larger suction / biopsy lumens (e.g., 122 in FIG. 1) can be cleaned by brushing or pull throughs. Air / water channels (e.g., channels 124 and 126) aregenerally too small for brushes so these lumens are usually only flushed with water and cleaning solution.

[0034] There has been significant research to show that the method of cleaning with brushes, even when performed as prescribed, may not completely remove biofilm in endoscope lumens. As well as lacking in efficacy, the current manual brushing procedures suffer from other drawbacks. The large number of different endoscope manufacturers and models results in many minor variations of the manual cleaning procedure. This has led to confusion and ultimately poor compliance in cleaning processes.

[0035] The current system of manual brushing is also labor intensive, leading to increased cost. Thus, the current approaches to cleaning and disinfecting the lumens in medical cleaning apparatus are still inadequate and residual microorganisms are now recognized as a significant threat to patients and staff exposed to these devices. For example, there is evidence of bacterial transmission between patients from inadequate cleaning and disinfection of internal structures of endoscopes which in turn has led to patients acquiring mortal infections. Between 2010 and 2015 more than 41 hospitals worldwide, most in the U.S., reported bacterial infections linked to the scopes, affecting 300 to 350 patients (http: / / www.modemhealthcare.com / article / 20167415 / NEWS / 167419935). It would be expected that a reduction in the bioburden in various medical devices would produce a concomitant overall reduction in infection rates and mortality.

[0036] In addition, if endoscopes are not properly cleaned and dried, biofdm can build up on the lumen wall. Biofilms start to form when a free-floating microorganism attaches itself to a surface and surrounds itself with a polysaccharide layer. The microorganism then multiplies, or begins to form aggregates with other microorganisms, increasing the extent of the polysaccharide layer. Multiple sites of attachment can in time join up, forming significant deposits of biofilm. Once bacteria or other microorganisms are incorporated in a biofilm, they become significantly more resistant to chemical and mechanical cleaning than they would be in their free-floating state. The organisms themselves are not inherently more resistant, rather, resistance is conferred by the polysaccharide film and the fact that microorganisms can be deeply embedded in the film and isolated from any chemical interaction. Any residual biofilm remaining after an attempt at cleaning quickly returns to an equilibrium state and further growth of microorganisms within the film continues. Endoscopes lumens are particularly prone to biofilm formation. They are exposed to significant amounts of bioburden, and subsequentcleaning of the long narrow lumens is quite difficult due to inaccessibility and the inability to monitor the cleaning process.

[0037] There is considerable pressure in medical facilities to reprocess endoscopes as quickly as possible. Because endoscopes are cleaned by hand, training and attitude of the technician are important in determining the cleanliness of the device. Residual biofilm on instruments can result in a patient acquiring an endoscope acquired infection. Typically, these infections occur as outbreaks and can have fatal consequences for patients.

[0038] As noted, there are a number of different types of cleaning fluids that can be used to clean the lumens of a device. These cleaning fluids include, for example, water, modified water, detergent solutions (e.g., mixtures of water and detergent), liquid-powder mixtures (e.g., mixtures of sodium bicarbonate powder and water), etc. The use of a liquid-powder mixture propelled through respective lumens of a device has been found to be particularly effective at removing unwanted matter via physical contact - yet safely - interacting with the lumens to clean them. In these techniques, a liquid-powder mixture may be created, apportioned into a suitable amount, and then delivered at a suitable velocity through at least a portion of the lumen. The liquid-powder mixture is sometimes referred to herein as a ‘slurry,’ and the apportioned amount of the liquid-powder mixture is sometimes referred herein to as a ‘cleaning shot’ or ‘shot.’

[0039] FIG. 2A illustrates an exemplary method 240 of cleaning a lumen of a medical device using a cleaning fluid in the form of apportioned amount of the liquid-powder mixture (cleaning shot). The method 240 of FIG. 2A begins at 242 with the creating, mixing, or otherwise obtaining of a liquid-powder mixture. At 244, the liquid-powder mixture is apportioned into a suitable amount. At 246, the apportioned amount of the liquid-powder mixture is delivered (e.g., propelled) through at least a portion of a lumen to be cleaned. This process may of course be implemented in any of a variety of ways.

[0040] For example, any suitable liquid-powder mixture may be implemented. As can be appreciated, the liquid component of the mixture can facilitate the fluidity of the mixture, while the presence of the powder can act to interact with the walls of the target lumen (e.g., channel) to thereby clean the lumen. In accordance with certain examples, the powder component of the liquid-powder mixture is present within the mixture in amounts greater than the respective saturation limit within the respective liquid, which can facilitate a cleaning interaction between the mixture and the walls of the lumen. In certain embodiments, the liquid-powder mixturecomprises mixture of sodium bicarbonate powder and water, where the sodium-bicarbonate is present in an amount greater than the respective saturation level. For example, in a number of embodiments, sodium-bicarbonate can, at certain stages, be present in an amount greater than 10% of the mixture by mass. It has been determined that a mixture of sodium bicarbonate and water can be particularly effective in the disclosed application. Moreover, these constituent components are readily available. However, it would be appreciated that any suitable liquidpowder mixture can be used in alternative examples. One consideration for powder selection may be that it has a Mohs hardness higher than a target biofilm / bioburden, but softer than the target lumen walls.

[0041] In some arrangements, the powder in the mixture is present in an amount below the respective saturation of the associated liquid. However, the liquid is delivered to the target lumen prior to the complete dissolution of the powder in the liquid. In this way, the undissolved powder can still interact with the target lumen to be cleaned.

[0042] Moreover, it is to be appreciated that the liquid-powder mixture can be created / obtained in any of a variety of ways. For example, in certain embodiments, a powder is obtained from a cartridge or other consumable chamber / container, water is obtained from a tap, and these constituent components are mixed within a holding chamber (or within the consumable chamber itself) proximate (e.g., within days or weeks) to the time of cleaning. This approach may be advantageous insofar as powders such as sodium bicarbonate can be relatively stable and can have a long shelf life and suitable sources of water are readily available. However, in other embodiments, the mixture may be obtained in an already mixed form.

[0043] As noted, method 240 involves apportioning the liquid-powder mixture into a suitable amount. As illustrated, the apportioned amounts are subsequently delivered through a lumen to be cleaned. Delivering discrete amounts of the mixture can be advantageous insofar as the discrete amounts can be delivered periodically at suitable velocities, and the periodic application of the composition can help facilitate the cleaning of the lumen while not clogging / blocking the target lumens. Moreover, the discrete nature of the delivered amounts can facilitate the maintenance of a suitable delivery velocity, which can also aid cleaning. For example, if the liquid-powder mixture was delivered continuously (and not in discrete, apportioned amounts), this approach might risk ‘clogging’ or otherwise obstructing the lumen to reduce the velocity at which the liquid-powder mixture flows through the lumen, and can thereby impact cleaning efficacy.

[0044] Notably, different amounts of liquid-powder mixture may be differently suitable for the different characteristics of lumens to be cleaned. For example, air / water channels within an endoscope are typically amongst the narrowest lumens and, accordingly, may be more suitably cleaned with relatively smaller amounts of a liquid-powder mixture (whereas using larger amounts of a liquid-powder mixture may result in blocking such a narrow channel). In contrast, the suction / biopsy channels of an endoscope are typically amongst the widest lumens and, accordingly, may be more suitably cleaned with relatively larger amounts of liquid-powder mixture. As such, the amount of liquid-powder mixture apportioned for use in cleaning a given lumen is a function of the geometry of the lumen to be cleaned. It should of course be appreciated that the amount of liquid-powder mixture apportioned can also or alternatively be a function of any of a variety of parameters, including those that relate to the target.

[0045] The apportioned amount of the liquid-powder mixture can be determined in any of a variety of ways. For example, in certain embodiments, a valve may be used to draw a target amount of liquid-powder mixture from a reservoir. In some embodiments, a self-regulating pressurized system is used to draw a suitable amount of liquid-powder mixture from the reservoir.

[0046] As noted, method 240 of FIG. 2A further includes delivering the apportioned amount of liquid-powder mixture through at least a portion of the lumen to be cleaned. In general, a carrier fluid (e.g., air, water, etc.) is used to deliver (e.g., propel) the apportioned amount of the liquid-powder mixture through at least a portion of the lumen to be cleaned at a suitable velocity. The apportioned amount of the liquid-powder mixture is delivered in a manner (e.g., suitable size, suitable velocity, etc.) to provide an appropriate physical interaction between the mixture and the walls of the lumen, meaning that the undissolved powder will physically contact or run against the walls of the lumen to remove contaminants (e.g., bioburdens) therefrom. Of course, the apportioned amount of the liquid-powder mixture may be delivered through the lumen in any suitable way to enable cleaning of a lumen.

[0047] Notably, method 240 can be iterated any number of times to facilitate the cleaning of the lumen of a medical device. For example, FIG. 2B illustrates the delivery of one cleaning shot 248 (e.g., an apportioned amount of a liquid-powder mixture) through a lumen 252 to remove contaminants from the walls of the lumen 252, where the general direction of travel of the shot 248 is represented by arrows 261. That is, as shown, the lumen 252 has one or more contaminants 254 (e.g., bioburdens) disposed on the inner surface / walls 256 of the lumen. It is further illustrated that the cleaning shot 248 is delivered through the lumen 252 to physicallyinteract with the walls 256 of the lumen 252 and thereby remove the contaminants 254 therefrom. The cleaning shot 248 can be considered to be entrained within a carrier fluid, which in this example comprises air (represented by arrows 263).

[0048] In general, cleaning shots presented herein, such as cleaning shot 248, can have different forms / arrangements. For example, in certain embodiments, a cleaning shot presented herein can be a relatively singular / unitary mass (e.g., potentially substantially occluding the lumen 252 while traveling therethrough), which is sometimes referred to herein as a “unitary shot.” However, in other embodiments, a cleaning shot can be an “agglomeration” or “cluster” of smaller masses / groups that travel through the lumen 252 as a loose group (e.g., potentially not occluding the lumen while traveling therethrough), sometimes referred to herein as a “cluster shot.” FIG. 2B schematically illustrates an example in which the shots 248 are cluster shots.

[0049] In certain embodiments, a cleaning shot can transition between different forms during the shot’s life cycle. For example, a shot could be apportioned (initially created) as a unitary shot, but then transition to a cluster shot. This transition could occur before entering the lumen (e.g., in a delivery chamber) and / or while traveling through the lumen.

[0050] As noted above, FIG. 2B generally illustrates the delivery of a cleaning shot 248 through a lumen 252. In certain examples, FIG. 2B represents a one stage / phase of a cleaning process, while FIG. 2C represents another stage / phase of the cleaning process. More specifically, in certain examples, before or after a cleaning shot 248 is delivered through the lumen 252 (as in FIG. 2B), a fluid flow is delivered through the lumen 252 without any shots The cleaning shots 248 can be formed using water or another liquid. In FIGs. 2B and 2C, the general direction of travel is again represented by arrows 261.

[0051] In certain examples, water 275 can be delivered at any of a number of different stages of a device lumen cleaning cycle. In one example, the water 275 of FIG. 2C is configured to remove residuals 247 from the lumen 252. The residuals 247 can comprise, for example, some remaining portion of the contaminant 254 and / or portions of the shots 248 that may remain on the walls 256 of the lumens 252 after passage of the shots 248 (e.g., a shot 248 can break up into different clusters, some of which remain on the walls 256 of the lumen 252). If present, portions of the shot 248 that may remain on the walls 256 of the lumens 252 may aid in the cleaning process as these portions are flushed through the lumen 252 by the water 275.

[0052] In certain embodiments, a fluid flow (e.g., water) is interspersed between the delivery of cleaning shots. In other embodiments, multiple shots could alternatively be delivered through a lumen either simultaneously or sequentially, without separation (e.g., without a fluid- only flow).

[0053] Importantly, it should be appreciated that in certain embodiments, the cleaning shots 248 are delivered through the lumen 252 sequentially (e.g., one-at-a-time). In general, the use of a series of discrete / individual cleaning shots 248, as opposed to a single large flow, can allow the individual cleaning shots to maintain sufficient kinetic energy to pass through the lumen 252 at a rate that allows the particles with the shots 248 to advantageously interact with, and remove contaminants from, the lumen walls 256.

[0054] As noted above, a lumen cleaning process, such as described above with reference to FIGs. 2A, 2B, and 2C, can be implemented in a number of different manners with a number of different lumens. For context, one specific example implementation is described with reference to cleaning at least part of the endoscope 100 of FIG. 1.

[0055] More specifically, in one example cleaning process / cycle, one (1) cleaning shot is fired / shot into the water-jet channel 128 via water-jet connector 139, nine (9) cleaning shots are then fired into the biopsy / suction channel 122 via suction connector 137, one (1) cleaning shot is then fired into the water-jet channel 128 via water-jet connector 139, three (3) cleaning shots are then fired into the distal section 122B of the biopsy / suction channel 122 via biopsy valve 118, one (1) cleaning shot is then fired into the water-jet channel 128 via water-jet connector 139, and then nine (9) cleaning shots are fired into the biopsy / suction channel 122 via suction connector 137. The cleaning cycle can further include firing / shooting six (6) cleaning shots into the air channel 124 via air connector 143 and firing six (6) cleaning shots into the water channel 126 via water connector 141 (e.g., in parallel). The firing of the cleaning shots within each target lumen can be preceded by, or followed by, a fluid flow, as described above with reference to FIG. 2C. The cleaning shots and fluid flows can be delivered via one, or possible multiple connectors (e.g., one connector for the air pipe and one connector for the air / water bottle).

[0056] In certain examples, approximately 180-200 grams of a slurry could be used to clean a typical flexible GI endoscope. For example, approximately use 80-100 grams can be used to clean a relatively large channel (e.g., suction / biopsy channel 122) with 21 shots in total and an approximately 15 second delay between each shot. For a relatively small channel (e.g., air / water channels), the process can use approximately 60-80 grams with 12 shots in total and an approximately 30 second delay between each shot. For other small channels (e.g., water-jet channel 128), the process can use approximately 10-20 grams with 3 shots in total and an approximately 30 second delay between each shot. Again, each of these channels can also receive a subsequent fluid flow (e.g., after each cleaning shot), as described above with reference to FIG. 2C.

[0057] As noted above, cleaning shots are delivered to a target lumen with a velocity that is suitable / sufficient to remove contaminants from the walls of the target lumen. The velocity of the cleaning shots can vary, for example, based on the attributes of the target lumen, the attributes of the liquid-powder mixture (slurry) used to form the shot, etc. In one illustrative example, the shot velocity for a relatively large lumen may be around 1000 mm / second.

[0058] In addition, the cleaning shots can be delivered within specific pressure and fluid flow (air) ranges. In certain examples, the cleaning shots can be delivered with a pressure up to approximately 26 pounds per square inch (psi) (air, note this is regulated by a PPR as described below), up to approximately 24psi (water), etc. Example air flow metrics can include approximately 50 standard liter per minute (SLPM) (large channel no load), approximately 11- 17 SLPM (large channel during dosing), approximately 7-10 SLPM (large channel during full load), approximately 5-7 SLPM (small channel no load), and approximately 0.1 SLPM (small channel during full load). It is to be appreciated that these ranges and values are merely illustrative.

[0059] In conventional arrangements for cleaning lumens, the cleaning fluid is typically introduced into a lumen at a proximal end of the lumen and the cleaning fluid typically exits the lumen at the distal end of the lumen. For example, FIG. 3 is a schematic diagram of the distal end 102 of endoscope 100 from FIG. 1, showing the distal end 157 of the biopsy / suction channel 122, the distal end 159 of water-jet channel 128, the nozzle 149 (e.g., where the air / water channels 124 / 126 collectively exit the endoscope), and a camera 151 disposed at a surface 153 of the distal end 102 of endoscope 100. During a conventional process to clean the lumens, the cleaning fluid used to clean biopsy / suction channel 122 exits at the distal end 157 of channel 122, the cleaning fluid used to clean water-jet channel 128 exits the distal end 159 of channel 128, and the cleaning fluid used to clean the air channel 124 or the cleaning fluid used to clean the water channel 126 exits via nozzle 149. Dashed line 155 in FIG. 3 generally illustrates the conventional path of cleaning fluids from the air channel 124 and the water channel 126 via nozzle 149.

[0060] As shown in FIG. 3, the distal end 157 of the biopsy / suction channel 122 and the distal end 159 of the water-jet channel 128 are each oriented such that the cleaning fluid from those channels exits away from the distal end 102 of the endoscope 100. However, the nozzle 149 has an opening 162 that is oriented substantially orthogonal to the distal end 102 of the endoscope 100. As a result, again as illustrated by dashed line 155, the cleaning fluid used to clean the air channel 124 or the cleaning fluid used to clean the water channel 126 exits substantially orthogonal to the distal end 102 (e.g., along the surface 153) and, in certain arrangements, in the direction of the camera 151.

[0061] The present inventors have discovered that, in certain circumstances, it may be useful to “modulate” (e.g., exert a modifying or controlling influence on, such as to reduce the force of, re-direct, etc.) the flow of cleaning fluid at one or more locations / parts of a fluid path during a lumen cleaning process (e.g., a fluid path that includes at least one lumen to be cleaned). As such, certain embodiments presented herein are directed to techniques for modulating the flow of a cleaning fluid at one or more locations of a fluid path in order to, for example, modulate / control the impact of the cleaning fluid on at least one target structure disposed at (e.g., in, along, or proximate to) the fluid path.

[0062] It is to be appreciated that the techniques presented herein can be applied to modulate a fluid flow and / or the control the impact of a cleaning fluid (e.g., control the aspects of the flow at / within) at various locations / parts of a fluid path. However, merely for ease of illustration, the techniques are primarily described herein with reference to modulating the flow of a cleaning fluid to control the impact of the fluid flow at the distal end of a lumen in the fluid path, such as at the distal end 157 of the biopsy / suction channel 122, at the distal end 159 of the water-jet channel 128, and / or at the nozzle 149. As used herein, the term “distal end” of a lumen encompasses nozzles, such as nozzle 149, located at the end of a lumen.

[0063] In certain examples presented herein, a fluid flow is modulated to control the impact of the cleaning fluid on at least one target structure. The at least one target structure could be, for example, camera 151 disposed at the distal end 102 of the endoscope 100.

[0064] As described further below, presented herein are a number of different techniques for modulating (e.g., exert a modifying or controlling influence on, such as to reduce the force of, re-direct, etc.) the flow of cleaning fluid at one or more locations, such as, the distal end, of certain lumens; relatedly, it may be beneficial to apply a different / altemative fluid regime / paradigm to modulate / control the impact on one or more target structures. In certainembodiments, the flow of a cleaning fluid is modulated at the distal end of a lumen by reducing the amount of physical interaction between the cleaning fluid and the target structure and / or lumen (e.g., using a relatively lower amount of a powder in a liquid-powder mixture, reducing the velocity of the cleaning fluid, using cleaning solutions with different physical properties, etc.). In other embodiments, the flow of a cleaning fluid is modulated at the distal end of a lumen through the use of a solid structure adjacent a target structure to one of direct the cleaning fluid in / to a selected direction or to physically shield the target structure from the cleaning fluid. In still other examples, the flow of a cleaning fluid is modulated at the distal end of a lumen by de-energizing the cleaning fluid. These example types of cleaning fluid modulation are illustrative and, as detailed below, other cleaning / flushing paradigms can be used to control the impact of a cleaning fluid at the distal end of a lumen, such as on a target structure.

[0065] As noted above, certain embodiments presented herein are directed to techniques for modulating the flow of a cleaning fluid at the distal end of a lumen thereby creating a softer interaction with the lumen and / or a target structure. In one such example, a lumen can be cleaned using water only, as opposed to a cleaning fluid (e.g., a mixture of detergent and water, liquid-powder mixture, etc.) that is configured to facilitate a relatively greater amount of physical interaction with walls of the lumen and / or the target structure relative to the physical interaction provided by water only. In a similar embodiment, a lumen can be cleaned using a mixture of detergent and water, as opposed to a liquid-powder mixture, again assuming the liquid-powder mixture is configured to facilitate a relatively greater amount of physical interaction with walls of the lumen and / or the target structure relative to the physical interaction provided by mixture of detergent and water. It is to be appreciated that these specific examples are merely illustrative.

[0066] In another such example, physical properties of the cleaning fluid could be modulated / adjusted to reduce the amount of physical interaction between the cleaning fluid and the lumen and / or the target structure. For example, if the cleaning fluid is a liquid-powder mixture, the cleaning fluid could be adjusted to use a relatively lower amount of the powder to thereby reduce the amount of physical interaction between the cleaning fluid and the lumen and / or the target structure (e.g., reduce the amount of sodium bicarbonate used during cleaning of a specific lumen).

[0067] In another example, the delivery attributes / parameters of a cleaning fluid could be modulated / adjusted to reduce the amount of physical interaction between the cleaning fluid and the lumen and / or the target structure (e.g., facilitate a relatively softer / gentler flush). Forexample, a cleaning fluid could be delivered at a relatively lower velocity in order to reduce the amount of physical interaction between the cleaning fluid and the lumen and / or the target structure. In another example, a cleaning fluid could be delivered at different time scales in order to reduce the amount of physical interaction between the cleaning fluid and the lumen and / or the target structure (e.g., only rigorously cleaning a specific channel with a liquidpowder mixture on an infrequent basis) .As noted above, certain embodiments presented herein are directed to techniques for modulating the flow of a cleaning fluid at the distal end of a lumen by using a solid structure adjacent the distal end to one of direct the cleaning fluid in / to a selected direction or to physically shield one or more target structures from the cleaning fluid (e.g., mechanically isolating target structures / components, such as the camera of an endoscope, during flushing / cleaning). In certain such examples, an adhesive member (e.g., adhesive bandage, adhesive film, etc.) is be applied to the distal end of the endoscope to physically shield the camera from cleaning fluid. FIG. 4 illustrates one such arrangement.

[0068] More specifically, shown in FIG. 4 is the distal end 102 of the endoscope 100 from FIG. 3 with an adhesive member 470 adhered to the surface 153 of the distal end 102. As shown, the adhesive member 470 is adhered to the distal end 102 prior to cleaning the air channel 124 or the water channel 126 so as to physically shield the camera 151 from cleaning fluid exiting via the nozzle 149 (e.g., the adhesive member 470 is disposed between the nozzle 149 and the camera 151), thereby modulating the cleaning fluid flow at the distal end 102 and controlling an impact of the cleaning fluid flow on the camera 151 by blocking cleaning fluid flow onto the camera 151 (e.g., from the nozzle 149). In this example, the adhesive member 470 substantially covers the camera 151, but it is to be appreciated that other arrangements for an adhesive member can be implemented in alternative embodiments. The adhesive member 470 is readily removable, such as by peeling the adhesive member 470 off the surface 153 away from distal end 102, to expose the camera 151, thereby enabling the camera 151 to operate (e.g., during insertion of the endoscope 100 in a recipient).

[0069] The use of an adhesive member is illustrative of one technique presented herein to physically shield one or more target structures from the cleaning fluid. For example, referring to the structure of FIG. 3, a temporary lacquer, enamel, rubber, or other material can also or alternatively be applied to the camera 151 prior to cleaning the air channel 124 or the water channel 126 so as to physically shield the camera 151 from cleaning fluid exiting via the nozzle 149. Such components are also readily removable to expose the camera 151.

[0070] FIGs. 5A-5C and FIGs. 6A-6E illustrate further embodiments in which a mechanical cap is used to physically shield one or more other elements, such as camera 151, from cleaning fluid exiting from the distal end of one or more lumens, such as from nozzle 149. More specifically, FIGs. 5A, 5B, and 5C are top, perspective, and cross-sectional views, respectively, of a mechanical cap 572 that is temporarily mechanically attached to the distal section 133 of the endoscope 100 prior to and during a lumen cleaning process. As shown, the mechanical cap 572 includes openings 574, 576, and 578 that are aligned with the distal end 157 of the biopsy / suction channel 122, with the distal end 159 of the water-jet channel 128, and with the nozzle 149, respectively. However, the mechanical cap 572 is configured to cover the camera 151 (not shown in FIGs. 5A-5C) so as to physically shield the camera 151 from cleaning fluid exiting via the biopsy / suction channel 122, the water-jet channel 128, and / or the nozzle 149, thereby modulating the cleaning fluid flow at the distal end 102. In other words, the mechanical cap 572 shields the camera 151 and controls an impact of the cleaning fluid flow on the camera 151, such as by deflecting cleaning fluid flow (e.g., from the distal end 157, from the distal end 159, from the nozzle 149) away from the camera 151.

[0071] The opening 578 includes a ramp 535 that is configured to redirect fluid exiting from the nozzle 149 away from the distal end 102 of the endoscope 100. More specifically, the ramp 535 is generally oriented at an angle relative to the direction at which the cleaning fluid exits the nozzle 149. As such, the cleaning fluid exiting from the nozzle 149 hits the ramp 535 and the cleaning fluid is directed away from the distal end 102 of the endoscope 100 instead of, for instance, along the surface 153 and toward the camera 151. Additionally, the ramp 535 extends between the camera 151 and the nozzle 149 to at least partially cover the camera 151 and modulate the cleaning fluid flow.

[0072] In certain examples, the mechanical cap 572 is configured to have an interference fit with the distal section 133 of the endoscope 100 (e.g., mechanically mates with the distal section 133 of the endoscope 100 adjacent the distal end 102). However, it is to be appreciated that the mechanical cap 572 could be mechanically attached to the distal section 133 or only the distal end 102 of the endoscope 100 in other manners. For example, in alternative arrangements the mechanical cap 572 could be temporarily adhered to the distal section 133 of the endoscope 100, the mechanical cap 572 could be coupled to the distal section 133 of the endoscope 100 via one or more mechanical fasteners, etc.

[0073] FIG. 6A is a perspective view of a mechanical cap 672A that is temporarily mechanically attached to the distal section 133 of the endoscope 100 during a lumen cleaningprocess. In this example, the mechanical cap 672A includes a central member 677A, arms 679A, a main body 680A, and one or more protruding features 637. The central member 677A is disposed around, and covers, the camera 151 (e.g., lens and lens retaining material of the camera 151), and the arms 679A connect the central member 677A to the main body 680A. The main body 680A is configured to have an interference fit with the distal section 133 of the endoscope 100 (e.g., mechanically mates with the distal section 133 of the endoscope 100 adjacent the distal end 102). However, it is to be appreciated that the main body 680A could be mechanically attached to the distal section 133 or only the distal end 102 of the endoscope 100 in other manners (e.g., temporary adhesive, one or more mechanical fasteners, etc.).

[0074] As noted, FIG. 6A illustrates that the mechanical cap 672A includes one or more protruding features 637. The protruding features 637 may be used to install / remove the mechanical cap 672A from the endoscope 100 (e.g., the protruding features 637 facilitate manual interaction with the mechanical cap 672A to apply a sufficient force that moves the mechanical cap 672A along the endoscope 100 off the distal section 133).

[0075] As noted, the central member 677A covers the camera 151, thereby modulating cleaning fluid flow to control an impact of the cleaning fluid flow on the camera 151, such as to deflect cleaning fluid flow away from the camera 151. However, the remainder of the distal end 102 of the endoscope 100 remains unobstructed such that the cleaning fluids can exit the distal end 157 of the biopsy / suction channel 122, the distal end 159 of the water-jet channel 128, and the nozzle 149 substantially unimpeded. To this end, the mechanical cap 672A includes openings 682A formed through the main body 680A and extending between the arms 679A to allow cleaning fluid flow out of the endoscope 100 via the distal end 157, the distal end 159, and the nozzle 149 and through the main body 680A. FIG. 6A illustrates an example that includes three arms 679A. It is to be appreciated that this specific arrangement is merely illustrative and that other embodiments can include different numbers / arrangements of arms 679A, a different central member 677A, a different main body 680A, etc.

[0076] FIG. 6B is a perspective view of a mechanical cap 672B that is temporarily mechanically attached to the distal section 133 of the endoscope 100 during a lumen cleaning process. The mechanical cap 672B shares some features as those of the mechanical cap 672A, such as a main body, shown as main body 680B, configured to have an interference fit with the distal section 133 of the endoscope 100 (e.g., mechanically mates with the distal section 133 of the endoscope 100 adjacent the distal end 102), a central member, shown as central member 677B, disposed around, and covering, the camera 151, arms, shown as arms 679B, connectingthe central member 677B to the main body 680B, and openings, shown as openings 682B. The openings 682B are formed through the main body 680B and extend between the arms 679B to allow cleaning fluid flow out of the endoscope 100 via the distal end 157, the distal end 159, and the nozzle 149 and through the main body 680B. Therefore, the mechanical cap 672B may provide similar benefits / advantages and may operate similarly in comparison to the mechanical cap 672A for modulating the cleaning fluid flow to control an impact of the cleaning fluid flow on the camera 151.

[0077] However, the mechanical cap 672B is configured to couple to the endoscope 100 using a different mechanism than that shown in FIG. 6A. For instance, the mechanical cap 672B may not include any protruding features, but is instead pre-installed on or coupled to a base member 664 (e.g., an applicator), which helps secure the main body 680B onto the endoscope 100 via an interference fit. In particular, the base member 664 includes a base body 665 with an opening 666 configured to receive the endoscope 100. The base member 664 also includes prongs 667 extending from the base body 665. The prongs 667 are configured to extend into the main body 680B of the mechanical cap 672B while the mechanical cap 672 is pre-installed on or coupled to the base member 664. FIGs. 6C-6E illustrate a sequence in which an assembly of the mechanical cap 672B pre-installed on the base member 664 can be used to secure the mechanical cap 672B to the endoscope 100.

[0078] More specifically, FIG. 6C is a perspective view of the mechanical cap 672B preinstalled on the base member 664 (e.g., by inserting the prongs 667 of the base member 664 into the main body 680B of the mechanical cap 672B). The mechanical cap 672B and the base member 664 are sometimes collectively referred to as cap assembly 671.

[0079] As shown in FIG. 6C, the cap assembly 671 is configured to couple to the endoscope 100 by inserting the distal section 133 into the base body 665 the base member 664 (e.g., via the opening 666) and into the main body 680B of the mechanical cap 672B. In some embodiments, the mechanical cap 672B and / or the base member 664 includes a feature to help orient the mechanical cap 672B with respect to the distal end 102 to align (e.g., rotationally align) the central member 677B with the camera 151 (e.g., lens and lens retaining material of the camera 151) to cover the camera 151. By way of example, the mechanical cap 672B includes an indicator 673 formed on the main body 680B. Rotating the mechanical cap 672B such that the indicator 673 is positioned adjacent to (e.g., circumferentially aligned with) the distal end 157 aligns the central member 677B with the camera 151. Thus, a user can visually inspect and adjust the orientation of the mechanical cap 672B relative to the distal end 102based on the position of the indicator 673 relative to the distal end 157 of the biopsy / suction channel 122 (see FIG. 1) to install the cap assembly 671 onto the endoscope 100 such that the central member 677B covers the camera 151. In certain embodiments, the base member 664 also includes a feature, such as a cutout / notch 669, which can be used to orient the mechanical cap 672B with respect to the endoscope 100 (e.g., by circumferentially aligning the notch 669 with the distal end 157) to align the central member 677B with the camera 151.

[0080] FIG. 6D is a perspective view of the cap assembly 671 installed onto the endoscope 100 such that the indicator 673 of the mechanical cap 672B is adjacent to (e.g., circumferentially aligned with) the distal end 157 of the endoscope 100. Therefore, the central member 677B of the mechanical cap 672B is rotationally aligned with and covers the camera 151 to modulate cleaning fluid flow to control an impact of the cleaning fluid flow on the camera 151.

[0081] FIG. 6E is a perspective view of the mechanical cap 672B installed onto the endoscope 100 and the base member 664 being separated or decoupled from the mechanical cap 672B while remaining coupled to the endoscope 100 (e.g., the distal section 133). In particular, the base member 664 is moved along the endoscope 100 in a direction 675 away from the mechanical cap 672B while the endoscope 100 still extends through the opening 666 of the base member 664. Such movement of the base member 664 away from the mechanical cap 672B moves the prongs 667 of the base member 664 out of the main body 680B of the mechanical cap 672B to help secure the main body 680B onto the endoscope 100.

[0082] As an example, the prongs 667 are composed of a material (e.g., polytetrafluoroethylene) having a low coefficient of friction. Thus, the base member 664 may slide more easily along the endoscope 100, such as to couple the base member 664 to the endoscope 100. While the mechanical cap 672B is pre-installed on or coupled to the base member 664, the prongs 667 extend within the main body 680B of the mechanical cap 672B (e.g., between the main body 680B and the endoscope 100) to block the main body 680B from contacting the endoscope 100. Such an arrangement of the prongs 667 enables the base member 664 and the mechanical cap 672B to slide more easily along the endoscope 100. Consequently, the arrangement of the mechanical cap 672B pre-installed on or coupled to the base member 664 as the cap assembly 671 enables the mechanical cap 672B to couple to the endoscope 100 more easily (e.g., without a user having to exert an excessive amount of force). However, separating the base member 664 from the mechanical cap 672B removes the prongs 667 from within the main body 680B. Consequently, the main body 680B comes into contact with the endoscope 100. The main body 680B is composed of a material (e.g., silicone rubber, ethylenepropylene diene terpolymer rubber) with a high coefficient of friction. The high coefficient of friction between the main body 680B and the endoscope 100 restricts movement of the mechanical cap 672B along the endoscope 100, thereby securing the mechanical cap 672B to the endoscope 100. Therefore, decoupling the base member 664 from the mechanical cap 672B causes the main body 680B to grip the endoscope 100 and couple the mechanical cap 672B to the endoscope 100 more securely.

[0083] A similar sequence in reverse order can be performed to decouple the mechanical cap 672B from the endoscope 100. That is, the base member 664 is moved to insert the prongs 667 into the main body 680B of the mechanical cap 672B (e.g., to provide the cap assembly 671 on the endoscope 100), thereby blocking the main body 680B from contacting the endoscope 100 and facilitating movement of the mechanical cap 672B along the endoscope 100. The base member 664 and the mechanical cap 672B may then be moved together along the endoscope 100 to decouple from the endoscope 100.

[0084] In additional or alternative embodiments, the mechanical cap 672B can be removed from the endoscope 100 without having to initially pre-install or couple the mechanical cap 672B to the base member 664. For instance, a sufficient force applied to the mechanical cap 672B overcomes the frictional force between the main body 680B and the endoscope 100 to move the mechanical cap 672B along the endoscope 100 to be decoupled from the endoscope 100, even while the main body 680B tightly captures the endoscope 100.

[0085] FIGs. 5A-5C and FIGs. 6A-6E illustrate arrangements that generally cover the camera 151. In alternative arrangements, a structure that is configured to redirect the cleaning fluid flow away from a target structure could be used. In such embodiments, the target structure from which the cleaning fluid is redirected away from (e.g., camera 151) could remain uncovered (i.e., a device, such as a mechanical cap, is not coupled to and shielding the component).

[0086] As noted above, certain embodiments presented herein are directed to techniques for modulating the flow of a cleaning fluid at the distal end of a lumen by de-energizing the cleaning fluid as it exits the lumen. FIGs. 7 and 8 illustrate two such arrangements.

[0087] More specifically, referring first to FIG. 7, shown is a diffusing structure in the form of a diffusing brush 781, comprising a plurality of brush fibers (bristles) 767, that is configured to be positioned adjacent to (e.g., abutting) the distal end 102 of the endoscope 100. The diffusing brush 781 is configured to de-energize the cleaning fluid as it exits one or more of the distal end 157 of the biopsy / suction channel 122, the distal end 159 of the water-jet channel128, or the nozzle 149. For example, the brush fibers 767 may absorb the kinetic energy from the cleaning fluid, thereby reducing a speed of the cleaning fluid, to modulate the flow of cleaning fluid and control an impact of the cleaning fluid on the camera 151. However, the nature of the diffusing brush 781 still allows the cleaning fluid to pass therethrough. It is to be appreciated that the diffusing brush 781 is illustrative and that other types of diffusing structures that permit the flow of fluid therethrough while de-energizing the fluid flow could be used in alternative embodiments.

[0088] Referring next to FIG. 8, shown is an embodiment that uses an intercepting fluid flow (e.g., a flow of water, air, or other fluid) to de-energize a cleaning fluid ats it exits a lumen. More specifically, shown in FIG. 8 is the distal section of endoscope 100, where the distal end 102 is disposed in an enclosure 882. Also disposed in the enclosure is an intercepting fluid outlet 883 that is configured to deliver an intercepting fluid flow 884 to the enclosure. In particular, the intercepting fluid outlet 883 and the distal end 102 of the endoscope 100 are aligned relative to one another (e.g., via the use of sensors 884(A) and 884(B)) such that intercepting fluid flow 884 interacts with (intercepts) the cleaning fluid flow as it exits one or more the distal end 157 of the biopsy / suction channel 122, the distal end 159 of the water-jet channel 128, and the nozzle 149. The interaction between the intercepting fluid flow 884 and the cleaning fluid de-energizes the cleaning fluid flow as it exits the lumens to modulate the flow of cleaning fluid and control an impact of the cleaning fluid on the camera 151.

[0089] As noted above, other cleaning / flushing paradigms can be used to modulate / control the impact of a cleaning fluid flow at one or more locations of a fluid path. For example, in another arrangement, the impact of a cleaning fluid flow at the distal end of the lumen can be controlled by delivering the cleaning fluid flow to the lumen while the distal end of the lumen is initially closed. The closure of the distal end of the lumen forms a closed system in which the cleaning fluid can be “pulsed” (e.g., pushed / pulled or moved forward / backward). In other words, a pulsative agitation process is used while the distal end of the lumen (e.g., nozzle 149) is blocked / closed. After a period of time, the distal end of the lumen (e.g., nozzle 149) would be opened and the cleaning fluid would be released with a substantially lower amount of energy, relative to the energy of the cleaning fluid as first introduced into the closed system.

[0090] In another example, the impact of a cleaning fluid flow on a respective lumen and / or target structure at the distal end of the lumen can be controlled by delivering the cleaning fluid flow to / via the distal end of the lumen. In such embodiments, the cleaning fluid flow would exit from another part of the endoscope (e.g., the proximal end, the air / water cylinder, etc.).FIG. 9 illustrates one such arrangement for cleaning endoscope 100 in this manner. For ease of illustration and description, FIG. 9 only shows a portion of the endoscope 100 in a simplified schematic form.

[0091] More specifically, shown in FIG. 9 is the air channel 124 and the water channel 126. As noted, the air channel 124 also includes two sections, referred to as proximal section 124A and distal section 124B that are connected via the air / water cylinder (valve) 116. Similarly, the water channel 126 also includes two sections, referred to as proximal section 126A and distal section 126B that are connected via the air / water cylinder (valve) 116. The distal section 126B of the water channel joins to the distal section 124B of the air channel at a location 130 within the distal section 133 of the endoscope, and each exit the distal end 102 of the endoscope 100 via nozzle 149.

[0092] In the example of FIG. 9, the air channel 124 and the water channel 126 are cleaned using cleaning fluids introduced from two locations. In particular, as shown by arrows 985, the proximal sections 124A and 126A are cleaned by introducing the cleaning fluid from the proximal end of the lumens, where the cleaning fluid flows through the proximal sections 124A and 126A to the air / water cylinder 116. The cleaning fluid received at the air / water cylinder 116 from the proximal sections 124A and 126A exits via the air / water cylinder 116. However, as shown by arrows 986, the distal sections 124B and 126B are cleaned by introducing the cleaning fluid from the nozzle 149, where the cleaning fluid flows through the distal sections 124B and 126B to the air / water cylinder 116. The cleaning fluid received at the air / water cylinder 116 from the distal sections 124B and 126B exits via the air / water cylinder 116. Thus, the flow of cleaning fluid out of the endoscope 100 from the nozzle 149 in the illustrated arrangement is not substantial, and the cleaning fluid is therefore modulated to control an impact of the cleaning fluid on the camera 151 adjacent to the nozzle 149.

[0093] Although FIG. 9 only illustrates the air channel 124 and the water channel 126, it would be appreciated that the biopsy / suction channel 122 and the water-jet channel 128 could be cleaned in a similar manner. For example, in one arrangement, a connector may be provided such that a cleaning fluid could be delivered to the distal ends of all of the lumens either simultaneously or individually and the cleaning fluid would exit at a different portion of the endoscope 100 (e.g., biopsy valve 118, suction valve 114, etc.).

[0094] As noted, FIG. 9 illustrates an example in which the cleaning fluid exits via the air / water cylinder 116. In other embodiments, the impact of a cleaning fluid flow at the distal end of oneor more of the air channel 124 and the water channel 126 (at nozzle 149) can be controlled by delivering the cleaning fluid flow via the air / water cylinder 116. FIGs. 10A and 10B illustrate one such arrangement. For ease of illustration and description, FIGs. 10A and 10B only show portion of the endoscope 100 in a simplified schematic form.

[0095] More specifically, shown in FIGs. 10A and 10B is the air channel 124 and the water channel 126. As noted, the air channel 124 also includes two sections, referred to as proximal section 124A and distal section 124B that are connected via the air / water cylinder (valve) 116. Similarly, the water channel 126 also includes two sections, referred to as proximal section 126A and distal section 126B that are connected via the air / water cylinder (valve) 116. The distal section 126B of the water channel joins to the distal section 124B of the air channel at a location 130 within the distal section 133 of the endoscope 100 and each exit distal end 102 via nozzle 149.

[0096] In the example of FIGs. 10A and 10B, a cleaning fluid is introduced into the endoscope 100 via a connector (not shown in FIGs. 10A and 10B). That is, in certain aspects, the cleaning fluid is introduced via a connector for the air / water cylinder 116, where the connector is configured to fluidically isolate different lumens from another. For example, in certain examples, the connector could be configured to be inserted into the air / water cylinder of an endoscope and form four (4) separate fluidic paths (e.g. 4-way connector). In other embodiments, a connector presented herein could be configured to be inserted into the air / water cylinder of an endoscope and form two (2) separate fluidic paths (e.g., 2-way connector). Further details of example connectors are described in commonly owned and co-pending U.S. Provisional Application No. 63 / 580,504, the content of which is hereby incorporated by reference herein.

[0097] Returning to the examples of FIGs. 10A and 10B, the illustrative cleaning process occurs in two stages / flushes, where FIG. 10A illustrates the first stage / flush and FIG. 10B illustrates the second stage / flush. Referring first to FIG. 10A, the first flush is from the air / water cylinder 116 initially through the water channel 126, where arrows 1085A show the flow direction of the cleaning fluid. As shown, the cleaning fluid is first divided at a lower section (e.g., half) of the air / water cylinder 116 where a portion of the cleaning fluid travels through the proximal section 126A of the water channel 126 and a portion of the cleaning fluid travels through the distal section 126B of the water channel 126.

[0098] The portion of the cleaning fluid that travels through the proximal section 126A of the water channel 126 will continue to a common drain 1088 located at the proximal ends of the air channel 124 and the water channel 126. The other portion of the cleaning fluid, however, travels through the distal section 126B of the water channel 126 to location 130 within the distal section 133 of the endoscope 100 (e.g., where the distal section 124B of the air channel 124 joins the distal section 126B of the water channel 126). At 130, a portion of the remaining cleaning fluid exits via nozzle 149, while a portion of the remaining cleaning fluid travels through the distal section 124B of the air channel 124 towards the air / water cylinder 116. The connector by which the cleaning fluid is introduced via the air / water cylinder 116 is also configured to form fluidically-separate volumes within the air / water cylinder 116 (e.g., fluidically-separate the top half of the air / water cylinder 116 from the bottom half of the / water cylinder 116). As a result, the cleaning fluid returning to the air / water cylinder 116 from the distal section 124B of the air channel 124 will pass through the air / water cylinder 116 to the proximal section 124A of the air channel 124 and, ultimately, to the common drain 1088. In FIG. 10A, the lengths of the arrows 1085A generally present the relatively amounts of cleaning fluid that travel through each of the different sections of the lumen (e.g., longer arrows represent greater amounts of cleaning fluid and shorter arrows represent relatively smaller amounts of cleaning fluid).

[0099] Referring next to FIG. 10B, the second flush is from the air / water cylinder 116 initially through the air channel 124, where arrows 1085B show the flow direction of the cleaning fluid. As shown, the cleaning fluid is first divided at the upper section (e.g., upper half) of the air / water cylinder 116 where a portion of the cleaning fluid travels through the proximal section 124A of the air channel 124 and a portion of the cleaning fluid travels through the distal section 124B of the air channel 124.[ooioo] The portion of the cleaning fluid that travels through the proximal section 124A of the air channel 124 will continue to the common drain 1088 located at the proximal ends of the air channel 124 and the water channel 126. The other portion of the cleaning fluid, however, travels through the distal section 124B of the air channel 124 to location 130 within the distal section 133 of the endoscope 100 (e.g., where the distal section 124B of the air channel 126 joins the distal section 126B of the water channel 126). At 130, a portion of the remaining cleaning fluid exits via nozzle 149, while a portion of the remaining cleaning fluid travels through the distal section 126B of the water channel 126 towards the air / water cylinder 116. The connector by which the cleaning fluid is introduced via the air / water cylinder 116 is also configured to formfluidically-separate volumes within the air / water cylinder 116 (e.g., fluidically-separate the top half of the air / water cylinder 116 from the bottom half of the / water cylinder 116). As a result, the cleaning fluid returning to the air / water cylinder 116 from the distal section 126B of the water channel 126 will pass through the air / water cylinder 116 to the proximal section 126A of the water channel 126 and, ultimately, to the common drain 1088. In FIG. 10B, the lengths of the arrows 1085B generally present the relatively amounts of cleaning fluid that travel through each of the different sections of the lumen (e.g., longer arrows represent greater amounts of cleaning fluid and shorter arrows represent relatively smaller amounts of cleaning fluid).[ooioi] In the examples of FIGs. 10A and 10B, the relatively greater fluidic resistance of the downstream relatively narrower lumens inherently dampens the hydrodynamic forces of the flow at the nozzle 149. In general, this flushing paradigm can soften the hydrodynamic forces that would otherwise be experienced at the nozzle 149; i.e., the impact of the cleaning flow on the distal end of the endoscope 100 can be modulated / controlled. For example, by redirecting a portion of the cleaning fluid toward the common drain 1088 instead of out of the nozzle 149, the amount of cleaning fluid flowing toward the camera 151 can be reduced to correspondingly reduce the impact of cleaning fluid on the camera 151.

[0102] It is to be appreciated that reference to the “first” and “second” stages / flushes in FIGs. 10A and 10B is merely for ease of description and is not intended to imply or require any specific order of operations. Instead, it is to be appreciated that the flush described with reference to FIG. 10B could be performed prior to the flush described with reference to FIG. 10A. In addition, it is to be appreciated that the two flushes of FIGs. 10A and 10B need not be consecutive and that one or more cleaning operations can be interposed therebetween.

[0103] As explained above, in certain aspects of FIGs. 10A and 10B, a portion of the cleaning fluid can exit via nozzle 149. FIGs. 11A and 11B illustrate another embodiment in which a pinch valve 1099 is located downstream of the nozzle exit and can be closed, which blocks flow out of the nozzle 149, and opened, which enables flow out of the nozzle 149. The common drain 1088 and the pinch valve 1099 can be selectively opened / closed to modulate cleaning fluid flow through the endoscope 100. As an example, in a first configuration, both the common drain 1088 and the pinch valve 1099 are open. Such a configuration may be similar to the arrangement of the endoscope 100 shown in FIGs. 10A and 10B, in which a portion of the cleaning fluid flow introduced into the endoscope 100 (e.g., via the air / water cylinder 116) exits via the common drain 1088 and another portion of the cleaning fluid flow introduced intothe endoscope 100 exists via the nozzle 149. As another example, such as during a postcleaning cycle flush, the common drain 1088 can be closed and the pinch valve 1099 can be opened, and the cleaning fluid flow introduced into the endoscope 100 (e.g., via the air / water cylinder 116) exits via the nozzle 149 and not via the common drain 1088. As a further example, the common drain 1088 can be opened and the pinch valve 1099 can be closed, and the cleaning fluid flow introduced into the endoscope 100 (e.g., via the air / water cylinder 116) exits via the common drain 1088 and not via the nozzle 149. The illustrated embodiments include a cleaning component 1198 configured to receive cleaning fluid from each of the nozzle 149 and the common drain 1088, such as to process / discard the cleaning fluid and block reentry into the lumens of the endoscope 100. However, in additional or alternative embodiments, the common drain 1088 and / or the nozzle 149 direct cleaning fluid flow elsewhere, such as to different components / locations.

[0104] FIG. 12 is a flowchart of a method 1200 for directing a cleaning fluid flow. For example, the cleaning fluid flow is used to clean a device, such as an endoscope. The method 1200 provides a manner in which the cleaning fluid flow is moved to provide control an impact of the cleaning fluid on a target structure while maintaining the effectiveness of the cleaning fluid flow to clean the device. It should be noted that the method 1200 can be performed differently in additional or alternative embodiments. For example, an additional operation can be performed, and / or a depicted operation can be performed differently, performed in a different order, and / or not performed.

[0105] At block 1202, a cleaning fluid is directed along a fluid path that includes at least one lumen. That is, the cleaning fluid is directed through the at least one lumen. However, the cleaning fluid can also be directed outside of the at least one lumen, such as between a cleaning fluid source and the at least one lumen and / or out of the at least one lumen toward a postprocessing location.

[0106] At block 1204, the cleaning fluid flow is modulated to control an impact of the cleaning fluid flow on at least one target structure. By way of example, the at least one target structure includes a camera, and the cleaning fluid flow is modulated to reduce an impact of the cleaning fluid flow on the camera. Consequently, the cleaning fluid flow has a gentler impact on the camera to maintain a structural integrity, a positioning, and / or a functionality of the camera, while cleaning the at least one lumen effectively.

[0107] In some embodiments, the cleaning fluid flow is modulated by blocking cleaning fluid flow to the at least one target structure. For instance, a cover or cap is positioned over the at least one target structure. Consequently, the cover deflects the cleaning fluid flow away from the at least one target structure. As an example, the at least one target structure is positioned at a distal end of the lumen, and the cleaning fluid flow is discharged from the lumen at the distal end. The cover blocks the cleaning fluid flow discharged from the lumen from flowing onto the at least one target structure to modulate the cleaning fluid flow external to the lumen and control the impact of the cleaning fluid flow on the at least one target structure.

[0108] In additional or alternative embodiments, the cleaning fluid flow is modulated by deenergizing the cleaning fluid flow. One example mechanism to de-energize the cleaning fluid flow includes a diffusing brush positioned within the lumen, which therefore modulates the cleaning fluid flow within the lumen. Another example mechanism to de-energize the cleaning fluid flow includes an intercepting fluid flow that is directed to interact with the cleaning fluid flow. For instance, the cleaning fluid flow is directed out of the lumen (e.g., toward the at least one target structure), and the intercepting fluid flow is directed to interact with the cleaning fluid flow directed out of the lumen (e.g., to deflect the cleaning fluid flow away from the at least one target structure). In any case, the de-energizing the cleaning fluid flow modulates the cleaning fluid flow, either within or external to the lumen, to control the impact of the cleaning fluid on the at least one target structure.

[0109] In further embodiments, the cleaning fluid flow is modulated by redirecting the cleaning fluid flow away from the at least one target structure. For instance, the cleaning fluid flow is initially directed through the lumen toward the at least one target structure. In one implementation, the lumen includes a first section (e.g., a proximal section) and a second section (e.g., a distal section), the at least one target structure is disposed at the second section, and the cleaning fluid flow is directed from the first section toward the second section. Additionally, the lumen includes a cylinder or chamber disposed between the first section and the second section. The cylinder can discharge the cleaning fluid flow out of the lumen to redirect at least a portion of the cleaning fluid flow away from the at least one target structure. In such implementations, another cleaning fluid flow can be directed from the second section to the cylinder to further block cleaning fluid flow from the first section to the second section via the cylinder. In another implementation, a cleaning fluid flow is directed through the lumen (e.g., through the second section) toward at least one target structure. However, at least a portion of the cleaning fluid is directed from the lumen to an additional lumen to flow awayfrom the at least one target structure. In other words, at least a portion of the cleaning fluid flow is redirected from the lumen to the additional lumen, such as to clean the additional lumen, instead of toward the at least one target structure. In yet another implementation, the at least one target structure is disposed at a distal end of the lumen. A valve is implemented to control cleaning fluid flow out of the distal end. For example, closing the valve blocks cleaning fluid flow out of the distal end. Instead, the cleaning fluid flow is redirected, such as toward a different drain away from the at least one target structure. In this manner, closing the valve redirects the cleaning fluid flow away from the at least one target structure. In each of these examples, the cleaning fluid flow is modulated to reduce cleaning fluid flow toward the at least one target structure, thereby reducing an impact of the cleaning fluid flow on the at least one target structure.

[0110] Further still, in certain embodiments, a composition of the cleaning fluid flow is adjusted to modulate the cleaning fluid flow to control an impact of the cleaning fluid flow on the at least one target structure. By way of example, physical properties of the cleaning fluid are adjusted, such as by reducing the amount of solid particles (e.g., powder) in the cleaning fluid. Adjusting the physical properties of the cleaning fluid also controls an impact of the cleaning fluid flow on the at least one target structure by changing (e.g., reducing, limiting) a potential physical interaction between the cleaning fluid and the at least one target structure.[ooni] As noted, merely for ease of illustration, the techniques presented herein are primarily described with reference to cleaning a specific type of medical lumen, namely the channels of an endoscope, via an automated cleaning process using a fluidic composition and a lumen cleaning device. However, it will be appreciated that the invention is not limited to use with endoscopes or, more generally, to only use with medical devices, or with reference to fluidic composition. As such, it is to be appreciated that the techniques presented herein can be used to in association with the cleaning of lumens of a number of different devices / instruments used in any of a number of different applications, such as dental lines, food / drink lines, other medical lumens, etc. In addition, also as noted above, aspects of the techniques presented herein can also be used with other mechanical cleaning techniques and, as such, reference to automatic lumen cleaning with a fluidic composition and / or a lumen cleaning device is merely illustrative.

[0112] Certain aspects of the techniques presented herein have been described with reference to various descriptions of fluid dynamics. It is to be appreciated that these various descriptions are provided for purposes of illustration and that the innovation presented herein works regardless of the believed understanding of the fluid dynamics.

[0113] As should be appreciated, while particular uses of the technology have been illustrated and discussed above, the disclosed technology can be used with a variety of devices in accordance with many examples of the technology. The above discussion is not meant to suggest that the disclosed technology is only suitable for implementation within systems akin to that illustrated in the figures. In general, additional configurations can be used to practice the processes and systems herein and / or some aspects described can be excluded without departing from the processes and systems disclosed herein.

[0114] This disclosure described some aspects of the present technology with reference to the accompanying drawings, in which only some of the possible aspects were shown. Other aspects can, however, be embodied in many different forms and should not be construed as limited to the aspects set forth herein. Rather, these aspects were provided so that this disclosure was thorough and complete and fully conveyed the scope of the possible aspects to those skilled in the art.

[0115] As should be appreciated, the various aspects (e.g., portions, components, etc.) described with respect to the figures herein are not intended to limit the systems and processes to the particular aspects described. Accordingly, additional configurations can be used to practice the methods and systems herein and / or some aspects described can be excluded without departing from the methods and systems disclosed herein.

[0116] According to certain aspects, systems and non-transitory computer readable storage media are provided. The systems are configured with hardware configured to execute operations analogous to the methods of the present disclosure. The one or more non-transitory computer readable storage media comprise instructions that, when executed by one or more processors, cause the one or more processors to execute operations analogous to the methods of the present disclosure.

[0117] Similarly, where steps of a process are disclosed, those steps are described for purposes of illustrating the present methods and systems and are not intended to limit the disclosure to a particular sequence of steps. For example, the steps can be performed in differing order, two or more steps can be performed concurrently, additional steps can be performed, and disclosed steps can be excluded without departing from the present disclosure. Further, the disclosed processes can be repeated.

[0118] Although specific aspects were described herein, the scope of the technology is not limited to those specific aspects. One skilled in the art will recognize other aspects orimprovements that are within the scope of the present technology. Therefore, the specific structure, acts, or media are disclosed only as illustrative aspects. The scope of the technology is defined by the following claims and any equivalents therein.

[0119] It is also to be appreciated that the embodiments presented herein are not mutually exclusive and that the various embodiments may be combined with another in any of a number of different manners.

Claims

CLAIMSWhat is claimed is:

1. A method, comprising: directing a cleaning fluid flow along a fluid path that includes at least one lumen; and modulating the cleaning fluid flow at one or more locations in the fluid path to control an impact of the cleaning fluid flow on at least one target structure.

2. The method of claim 1, wherein modulating the cleaning fluid flow comprises: directing a portion of the cleaning fluid flow away from the at least one target structure.

3. The method of claim 2, wherein the at least one target structure is a camera of an endoscope, and wherein directing the portion of the cleaning fluid flow away from the at least one target structure comprises: deflecting the portion of the cleaning fluid flow via an apparatus coupled to the endoscope.

4. The method of claim 3, further comprising: directing an additional portion of the cleaning fluid flow out of the endoscope and through an opening of the apparatus.

5. The method of claim 3, further comprising: coupling the apparatus to the endoscope to align a cover member of the apparatus with the at least one target structure.

6. The method of claim 2, wherein the at least one lumen comprises a first section and a second section, the first section extends toward the at least one target structure and the second section extends away from the at least one target structure, and wherein directing the cleaning fluid flow along the fluid path comprises: directing the cleaning fluid flow into a chamber disposed between the first section and the second section, and wherein directing the portion of the cleaning fluid flow away from the at least one target structure comprises directing the portion of the cleaning fluid flow from the chamber to the second section.

7. The method of claim 2, wherein the at least one lumen comprises a first section and a second section, the first section extends toward the at least one target structure and the second section extends away from the at least one target structure, and wherein directing the cleaning fluid flow along the fluid path comprises: directing the cleaning fluid flow through the second section to a chamber disposed between the first section and the second section, and wherein directing the portion of the cleaning fluid flow away from the at least one target structure comprises discharging the portion of the cleaning fluid flow via the chamber.

8. The method of claim 1, wherein modulating the cleaning fluid flow comprises: de-energizing the cleaning fluid flow.

9. The method of claim 8, wherein de-energizing the cleaning fluid flow comprises: diffusing the cleaning fluid flow with a diffusing brush.

10. The method of claim 8, wherein de-energizing the cleaning fluid flow comprises: delivering an intercepting fluid flow to the cleaning fluid flow.

11. The method of claim 8, wherein de-energizing the cleaning fluid flow comprises: reducing a speed of the cleaning fluid flow.

12. The method of claim 1, wherein the fluid path includes a proximal end and distal end, and wherein modulating the cleaning fluid flow comprises: delivering the cleaning fluid flow at a distal end of the fluid path.

13. The method of claim 1, wherein the fluid path includes a proximal end and distal end, and wherein modulating the cleaning fluid flow comprises: delivering the cleaning fluid flow at a location between the proximal end and the distal end of the fluid path.

14. An apparatus, comprising: a body configured to couple to an endoscope; a cover member extending from the body and configured to align with a target structure of the endoscope to cover the target structure of the endoscope; andan opening formed into the body and configured to allow cleaning fluid flow out of the endoscope and through the body.

15. The apparatus of claim 14, wherein the body is configured to couple to a distal end of the endoscope such that the cover member aligns with the target structure on a surface of the distal end of the endoscope.

16. The apparatus of claim 14, wherein the body is configured to receive a distal section of the endoscope to couple to the endoscope.

17. The apparatus of claim 16, comprising a base member comprising prongs, wherein the prongs are configured to extend into the body to move the body radially outward to facilitate receipt of the distal section of the endoscope in the body.

18. The apparatus of claim 17, wherein the body is configured to grip the endoscope upon removing the prongs from the body.

19. The apparatus of claim 17, wherein the base member defines an opening configured to receive the distal section of the endoscope.

20. The apparatus of claim 19, wherein the base member is configured to couple to the body to provide an assembly, the assembly is configured to receive the distal section of the endoscope to couple the body to the endoscope, and the base member is configured to move along the endoscope to decouple from the body while the body remains coupled to the endoscope.

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