Systems and methods for flushing a lumen with a fluid composition - Patents.com

Abstract

Presented herein are techniques for cleaning internal / inner lumens (e.g., channels, cylinders, valve sockets, connectors, etc.) of apparatus such as medical devices (medical instruments) using contaminant removal fluid compositions. In particular, the techniques presented herein introduce an apportioned amount of the contaminant removal fluid composition into the internal lumen of the medical device. The contaminant removal fluid composition is configured such that the contaminant removal fluid composition can clean (e.g., interact with and remove contaminants from) the walls of the internal lumen and is propelled through at least a portion of the internal lumen device.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to Australian Patent Application No. 2021 / 901729, entitled "Systems and methods for cleaning a medical device having a lumen using abrasive fluidic compositions", filed on June 9, 2021, and Australian Patent Application No. 2021 / 901734, entitled "Systems and methods for the identification, evaluation, and / or closed-loop cleaning of lumens", filed on June 9, 2021. This application also incorporates by reference the contents of a concurrently filed patent application entitled "Systems and Methods for the Identification, Evaluation, and / or Closed-Loop Reprocessing of Lumens", and the contents of International Patent Application No. PCT / AU2022 / 050547, filed on June 3, 2022, entitled "Medical Device Port Connectors".

[0002] The present invention relates generally to techniques for cleaning the internal lumens of medical devices, such as, for example, endoscopes.

[0003] Any discussion of prior art throughout this specification should in no way be taken as an admission that such prior art is widely known or forms part of the common general knowledge in the art. [Background technology]

[0004] There are several different types of medical devices that can be used to perform diagnostic and / or surgical procedures. For example, an endoscope is a medical device that can be used to visually inspect hollow organs or body cavities. Specially designed endoscopes are used for different examinations, such as bronchoscopy, cystoscopy, gastroscopy, and rectoscopy. Endoscopes, as well as other available diagnostic and / or surgical medical devices, are reusable across multiple patients and contain one or more internal lumens that must be cleaned between uses. Summary of the Invention

[0005] According to a first aspect of the present invention, there is provided a method for cleaning at least one internal lumen of a medical device, the method comprising: mixing a liquid with a powder to form a slurry; applying at least one stream of fluid to a portion of the slurry to propel the portion of the slurry through at least one internal lumen of the medical device.

[0006] According to a second aspect of the present invention there is provided a method comprising the steps of: distributing the liquid powder mixture to the cleaning slugs; delivering the irrigation slug to the proximal end of the at least one lumen such that the irrigation slug passes from the proximal end to the distal end of the at least one lumen.

[0007] According to a third aspect of the present disclosure, there is provided a system, the system comprising: a holding chamber configured to hold the liquid powder mixture therein; at least one delivery chamber fluidly connected to at least one internal lumen of the device; at least one of a valve or a pump configured to provide a proportioned amount of the liquid powder mixture to the at least one delivery chamber; and a delivery mechanism configured to apply at least one stream of fluid to the apportioned amount of liquid powder mixture in the at least one delivery chamber to propel the apportioned amount of liquid powder mixture through the at least one internal lumen.

[0008] In one aspect, a method for cleaning at least one internal lumen of a medical device is provided, the method including mixing a liquid with a powder to form a slurry, and applying at least one stream of fluid to a portion of the slurry to propel the portion of the slurry through at least one internal lumen of the medical device.

[0009] In another aspect, a method is provided that includes distributing a liquid-powder mixture into a cleaning slug and delivering the cleaning slug to a proximal end of at least one lumen such that the cleaning slug passes from a proximal end to a distal end of the at least one lumen.

[0010] In another aspect, a system is provided that includes a holding chamber configured to hold a liquid powder mixture therein, at least one delivery chamber fluidly connected to at least one internal lumen of the device, at least one of a valve or a pump configured to provide an apportioned amount of the liquid powder mixture to the at least one delivery chamber, and a delivery mechanism configured to apply at least one flow of fluid to the apportioned amount of the liquid powder mixture in the at least one delivery chamber to propel the apportioned amount of the liquid powder mixture through the at least one internal lumen.

[0011] Unless the context clearly requires otherwise, throughout the description and claims, the words "comprise", "comprising", and the like are intended to be interpreted in their inclusive sense, i.e., "including but not limited to," rather than in their exclusive or exhaustive sense.

[0012] Embodiments of the present invention are described herein in conjunction with the accompanying drawings, in which: [Brief description of the drawings]

[0013] [Figure 1] 1 is a schematic diagram illustrating an endoscope having an internal lumen that can be cleaned using aspects of the technology presented herein. [Figure 2A] FIG. 2 is a flow diagram of an exemplary method for cleaning an internal lumen of a medical device using a contaminant removal fluid composition, in accordance with certain embodiments of the present invention. [Figure 2B] FIG. 2 is a schematic diagram illustrating a first stage / phase of a process for cleaning a lumen, according to certain embodiments of the present invention. [Figure 2C] FIG. 11 is a schematic diagram illustrating a second stage / phase of a process for cleaning a lumen, according to certain embodiments of the present invention. [Diagram 3] FIG. 1 is a flow diagram of a method for cleaning an internal lumen of a medical device using a contaminant removal fluid composition generated in a chamber pre-filled with at least one component, according to certain embodiments of the present invention. [Figure 4] 1 illustrates a system for cleaning an internal lumen of a medical device using a contaminant removal fluid composition, according to a specific embodiment of the present invention, where a delivery mechanism is used to propel a portion of the contaminant removal fluid composition through a target lumen. [Diagram 5] 1 illustrates another system for cleaning an internal lumen of a medical device using a contaminant removal fluid composition, where a delivery mechanism in the form of a delivery chamber is used to propel a portion of the contaminant removal fluid composition through a target lumen, according to certain embodiments of the present invention. [Figure 6A] 1 illustrates another system for cleaning an internal lumen of a medical device using a contaminant removal fluid composition, where the contaminant removal fluid composition is generated in a consumable chamber, according to certain embodiments of the present invention. [Figure 6B] 1 illustrates yet another system for cleaning an internal lumen of a medical device using a contaminant removal fluid composition, where the contaminant removal fluid composition is generated in a consumable chamber, according to certain embodiments of the present invention. [Figure 7] 1 illustrates a consumable chamber for holding a contaminant removal fluid composition for use in cleaning an internal lumen of a medical device, according to certain embodiments of the present invention. [Figure 8] 1 illustrates another system for cleaning an internal lumen of a medical device using a contaminant removal fluid composition, where a delivery manifold is used to deliver the contaminant removal fluid composition to a target lumen to be cleaned, according to certain embodiments presented herein. [Figure 9] 1 illustrates yet another system for cleaning an internal lumen of a medical device using a contaminant removal fluid composition, where a delivery manifold is used to deliver the contaminant removal fluid composition to a target lumen to be cleaned, according to certain embodiments presented herein. [Figure 10] 1 is a schematic diagram illustrating the air and water channels of an exemplary endoscope that can be cleaned using a contaminant removal fluid composition according to certain embodiments presented herein. [Figure 11] FIG. 13 is a schematic diagram illustrating the adjustment of a irrigation slug with a fluid delivery connector and a fluidic composite lumen, according to certain embodiments presented herein. [Figure 12] FIG. 2 is a flow diagram of an exemplary method for cleaning a fluidic compound lumen using a contaminant removal fluid composition, in accordance with certain embodiments of the present invention. [Figure 13] FIG. 2 is a flow diagram of another exemplary method for cleaning a fluidic compound lumen using a contaminant removal fluid composition, in accordance with certain embodiments of the present invention. [Figure 14] FIG. 2 is a block diagram of an exemplary control subsystem for use in cleaning an internal lumen of a medical device using a contaminant removal fluid composition, according to certain embodiments presented herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0014] Presented herein are techniques for cleaning internal / inner lumens (e.g., channels, cylinders, valve sockets, connectors, etc.) of apparatus such as medical devices using a "contaminant removal fluid composition," sometimes referred to herein simply as a "fluid composition." As used herein, the contaminant removal fluid compositions described herein generally include solid particles (e.g., powders).

[0015] According to embodiments presented herein, one or more apportioned amounts of contaminant removal fluid compositions are introduced into an internal lumen of a medical device. The apportioned amounts of contaminant removal fluid compositions are configured and propelled through at least a portion of the internal lumen device such that the apportioned amounts clean the walls of the internal lumen. That is, particles within the contaminant removal fluid composition can physically remove contaminants from the lumen walls.

[0016] Solely for ease of explanation, the techniques presented herein will be described primarily with reference to cleaning a particular type of lumen, namely, the channels of an endoscope. However, it will be understood that the present invention is not limited to use only with endoscopes, or more generally, with medical devices. Thus, it should be understood that the techniques presented herein can be used to clean the lumens of many different devices / instruments used in any of a number of different applications.

[0017] An endoscope is an elongated tubular medical device that can be rigid or flexible and incorporates an optical or video system and a light source. Typically, an endoscope is configured so that one end can be inserted into a patient's body through a surgical incision or through one of the body's natural orifices. Thus, the internal structure near the inserted end of the endoscope can be viewed by an external observer.

[0018] Endoscopes are used not only for examination, but also to perform diagnostic and surgical procedures. Endoscopic procedures are becoming increasingly popular because they are minimally invasive in nature, offering better patient outcomes (through reduced healing times and exposure to infection) and allowing hospitals and clinics to achieve higher patient turnover rates.

[0019] FIG. 1 is a schematic diagram of an exemplary endoscope 100 in which aspects of the technology presented herein may be implemented. As shown, the endoscope 100, like most endoscopes, has a long tubular structure with a distal end / tip 102 at one end for insertion into a patient and an opposing proximal or connector end 104, with a control handle 106 disposed between the two ends (e.g., generally centered along the length between the connector end 104 and the distal end 102). The connector end 104 includes multiple connectors that allow the endoscope to be attached to, for example, a light source 108, a water source 110, a suction source (not shown in FIG. 1), and a pressurized air source 112. For example, shown in FIG. 1A are 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 , in this example, is held by the operator during the procedure to control the endoscope 100 via valves, including a suction valve 114 , an air / water valve 116 , and a biopsy valve 118 , and a control wheel 120 .

[0020] As shown in Figure 1, the endoscope 100 includes internal channels that are used to either deliver air and / or water, provide suction, or allow access to forceps and other medical instruments needed during the procedure. Thus, the distal tip 102 includes a camera lens (not shown in Figure 1), as well as outlets for lighting, air, and water, and outlets for suction and forceps. Some of the internal channels run from one end of the endoscope 100 to the other, while other internal channels run through valve sockets in the control handle. Some channels branch off, while others join two into one.

[0021] 1 shows a biopsy / aspiration channel 122, an air channel 124, a water channel 126, and a water jet channel 128. The biopsy / aspiration channel 122 includes two sections, referred to as a proximal section 122A and a distal section 122B, which are connected via a suction valve 114. The air channel 124 also includes two sections, referred to as a proximal section 124A and a distal section 124B, which are connected via an air / water valve 116. Similarly, the water channel 126 also includes two sections, referred to as a proximal section 126A and a distal section 126B, which are connected via an air / water valve 116. The water channel distal section 126B joins the air channel distal section 124B at a location 130 within the distal end 102. The waterjet channel 128 extends directly from the connector end 104 to the distal end 102 (via the control handle 106) and is similarly referred to as having a proximal section 128A and a distal section 128B. The proximal sections 122A, 124A, 126A, and 128A of the channel are sometimes referred to as being disposed within a universal cord section (cord) 132 of the endoscope 100, while the distal sections 122B, 124B, 126B, and 128B of the channel are sometimes referred to as being disposed 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 channel located between the connector end 104 and a valve (e.g., valve 114 or 116) at the control handle 106 and / or a midpoint of the control handle 106, if applicable. Distal sections 122B, 124B, 126B, and 128B are portions of a channel disposed between a valve in the control handle 106 (e.g., valve 114 or 116) and / or a midpoint of the control handle 106 and the distal end 102 of the endoscope 102.

[0022] Due to the high cost of endoscopes, they must be reused. As a result, each endoscope must be thoroughly cleaned and disinfected or sterilized after each use to avoid cross-infection from one patient to the next. This includes not only cleaning the exterior of endoscope 100, but also cleaning and disinfecting the internal channels / lumens (e.g., lumens 122, 124, 126, and 128 in FIG. 1).

[0023] Endoscopes used in colonoscopy procedures are typically 2.5-4 meters long and have one or more luminal channels with diameters of a few millimeters or less. Ensuring such long narrow channels are properly cleaned and disinfected between patients presents a considerable challenge. The challenge of cleaning is also made difficult by the fact that there is not just one configuration / type of endoscope. In fact, there are a variety of endoscopic devices, each suited to a specific insertion application, such as colonoscopes inserted into the colon, bronchoscopes inserted into the airways, and gastroscopes for exploration of the stomach. For example, gastroscopes have a smaller diameter than colonoscopes. Bronchoscopes are again smaller and shorter in length, while duodenoscopes have a different tip design for accessing the bile duct.

[0024] For the first stage of the cleaning and disinfection process, mechanically removing biological residues from the lumen, various options are available. By far the most common technique for cleaning the lumen is to utilize small brushes attached to a long, thin, flexible wire. Brushing is the mandated means for cleaning the lumen in some countries. These brushes are fed into the lumen while the endoscope is submerged in warm water and cleaning solution. The brushes are then pushed / pulled through the length of the lumen to somehow scrape off the dirt / biological contamination. Manual back and forth scrubbing is typically required. Water and cleaning solution are then forced through the lumen. These forced brushing 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 with a wiping blade can also be used to physically remove the material. Liquid flow through the lumen with limited pressure can also be used.

[0025] However, typically only the larger aspiration / biopsy lumens (e.g., 122 in FIG. 1) can be cleaned by brushing or pulling through. The air / water channels (e.g., channels 124 and 126) are too small for a brush, so these lumens are typically flushed with water and cleaning fluids only.

[0026] After mechanical cleaning, chemical cleaning is performed to remove remaining biological contaminants. Because endoscopes are sensitive and expensive medical instruments, biological residues cannot be treated with high temperatures or harsh chemicals. For this reason, mechanical cleaning needs to be as thorough as possible. In many cases, current mechanical cleaning methods cannot completely remove biofilm from the lumen, especially when cleaning relies only on liquid flow. No matter how good the conventional cleaning process is, it is almost inevitable that a load of small microorganisms will remain in the channel.

[0027] There has been significant research showing that brushing methods, even when performed as prescribed, do not always completely remove biofilm from endoscope lumens. In addition to lacking in effectiveness, current manual brushing techniques have other shortcomings. The large number of different endoscope makes and models results in many small variations in manual cleaning techniques. This leads to confusion and ultimately poor compliance with the cleaning process. The current system of brushing is also dangerous in that the chemicals currently used to clean endoscopes can have adverse effects on reprocessing staff.

[0028] The current system of manual brushing is also labor intensive and leads to increased costs. Thus, the current approach to cleaning and disinfecting the lumens in medical cleaning devices remains 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 the internal structures of endoscopes, which in turn has led to patients acquiring fatal infections. Between 2010 and 2015, more than 41 hospitals around the world, mostly in the United States, reported bacterial infections associated with endoscopes, affecting 300-350 patients (http: / / www.modernhealthcare.com / article / 20167415 / NEWS / 167419935). It is expected that a reduction in the degree of biological contamination in various medical devices will result in an overall reduction in infection and mortality rates.

[0029] Furthermore, if the endoscope is not properly cleaned and dried, biofilms can accumulate on the luminal walls. Biofilms begin to form when free-floating microorganisms attach themselves to a surface and are surrounded by a protective polysaccharide layer. The microorganisms then begin to grow or aggregate with other microorganisms, increasing the extent of the polysaccharide layer. Multiple attachment sites can combine in time to form significant deposits of biofilm. Once bacteria or other microorganisms are incorporated into a biofilm, they become significantly more resistant to chemical and mechanical cleaning than if they were in a free-floating state. The organisms themselves are not inherently more resistant, but rather the resistance is conferred by the polysaccharide film, and in fact the microorganisms can become deeply embedded in the film and isolated from any chemical interaction. Any residual biofilm remaining after cleaning attempts quickly returns to equilibrium, and further growth of the microorganisms within the film continues. Endoscope lumens are particularly prone to biofilm formation. They are exposed to a significant amount of biological contamination, and subsequent cleaning of long narrow lumens is very difficult due to the inability to access and monitor the cleaning process.

[0030] There is considerable pressure in healthcare facilities to reprocess endoscopes as quickly as possible. Because endoscopes are cleaned by hand, the training and attitude of the technician is important in determining the cleanliness of the device. Residual biofilm on the instruments can result in patients acquiring endoscope-acquired infections. These infections usually occur as outbreaks and can have fatal consequences for the patient.

[0031] It is an object of the technology presented herein to overcome or ameliorate at least one of the shortcomings of the prior art or to provide a useful alternative. In particular, as described in more detail below, the technology presented herein includes systems and methods for cleaning medical devices, such as endoscopes, having internal lumens (e.g., channels, ports / cylinders, etc.). For example, certain embodiments relate to the use of contaminant removal fluid compositions that are propelled through the respective lumens of the medical device. It has been determined that certain contaminant removal compositions and associated technology are particularly effective at removing unwanted material (yet safely) through physical contact that interacts with and cleanses the lumens. Thus, for example, the technology described herein can be used to remove biofilms that may be present within the lumens of a medical device.

[0032] Thus, according to certain embodiments, a method for cleaning an internal lumen of a medical device is provided. The method includes generating a liquid powder mixture (contaminant removal fluid composition), distributing the liquid powder mixture in a suitable amount, and delivering the distributed liquid powder mixture at a suitable speed through at least a portion of the lumen. Since the cleaning effectiveness / efficiency of the propelled distributed amount of liquid powder mixture (e.g., a portion of the contaminant removal fluid composition) may be proportional to the speed at which it passes through the lumen, it may be understood that a "suitable speed" or "appropriate speed" refers to a relatively high speed given the constraints of the fluid properties of the lumen and the mechanical constraints of the lumen (e.g., pressure limit).

[0033] The liquid powder mixture (e.g., contaminant removal fluid composition) may be referred to herein as a "slurry" and the dispensed amount of the liquid powder mixture may be referred to herein as a "cleaning slug" or "slug." Figure 2A illustrates an exemplary method 240 of cleaning a lumen of a medical device according to an embodiment of the present disclosure. As used herein, references to "cleaning" a lumen should be understood to refer to cleaning an inside / interior portion of the lumen, including the interior surface or "wall" that forms / defines the lumen.

[0034] 2A begins at 242 with generating, mixing, or otherwise obtaining 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 the lumen to be cleaned. This process can, of course, be implemented in any of a variety of ways according to embodiments of the present invention.

[0035] For example, any suitable liquid-powder mixture may be implemented. As can be appreciated, the liquid components of the mixture may facilitate the flowability of the mixture, while the presence of the powder may act to interact (e.g., clean) with the walls of the target lumen (e.g., channel), thereby cleaning the lumen. According to various embodiments presented herein, the powder components of the liquid-powder mixture are present in the mixture in amounts greater than their respective saturation limits in their respective liquids, which may facilitate cleaning interactions between the mixture and the walls of the lumen. In certain embodiments, the liquid-powder mixture includes a mixture of sodium bicarbonate powder and water, where the sodium bicarbonate is present in an amount that exceeds its respective saturation level. For example, in some embodiments, the sodium bicarbonate may be present in an amount that exceeds 10% by weight of the mixture at certain stages. It has been determined that a mixture of sodium bicarbonate and water may be particularly effective in the disclosed application. Moreover, these components are readily available. However, as described elsewhere herein, the technology presented herein is not limited to the use of a mixture of sodium bicarbonate and water, and thus, it will be appreciated that any suitable liquid-powder mixture may be implemented in accordance with embodiments of the present invention.

[0036] In some embodiments presented herein, the powder in the mixture is present in an amount less than the saturation of each of the associated liquids, provided that the liquid is delivered to the target lumen prior to complete dissolution of the powder in the liquid. In this way, undissolved powder can still interact with the target lumen to be cleaned.

[0037] It should further be understood that, according to embodiments of the present invention, the liquid powder mixture can be generated / obtained in any of a variety of ways. For example, in certain embodiments, the powder is obtained from a cartridge or other consumable chamber / container, the water is obtained from a tap, and these components are mixed in the holding chamber (or in the consumable chamber itself) close to the time of washing (e.g., within a few days or weeks). This approach can be advantageous as long as the powder, such as sodium bicarbonate, can be relatively stable and have a long shelf life, and a suitable source of water is readily available. However, in other embodiments, the mixture may be obtained in an already mixed form.

[0038] As previously mentioned, the method 240 involves distributing the liquid powder mixture in suitable amounts. As shown in the figure, the apportioned amounts are then delivered through the lumen to be cleaned. Delivering separate amounts of the mixture can be advantageous insofar as the separate amounts can be delivered periodically at a suitable rate, and applying the composition periodically can help facilitate cleaning of the lumen while not clogging / occluding the target lumen. Furthermore, the discrete nature of the delivered amounts can facilitate maintaining a suitable delivery rate, which can also aid in cleaning. For example, if the liquid powder mixture were delivered continuously (rather than discretely apportioned amounts), this approach could run the risk of "clogging" or occluding the lumen, which would slow the rate at which the contaminant removal fluid composition flows through the lumen, thereby significantly impacting the cleaning efficacy.

[0039] In particular, different amounts of the liquid powder mixture may be differently suited to different characteristics of the lumen to be cleaned. For example, the air / water channel in an endoscope is typically among the narrowest lumens and therefore may be better cleaned with a relatively small amount of the liquid powder mixture (whereas using a larger amount of the liquid powder mixture may block such narrow channels). In contrast, the aspiration / biopsy channel of an endoscope is typically among the widest lumens and therefore may be better cleaned with a relatively large amount of the liquid powder mixture. Thus, the amount of the liquid powder mixture allocated for use in cleaning a given lumen is a function of the geometry of the lumen to be cleaned. Of course, it should be understood that the amount of the liquid powder mixture allocated according to embodiments of the present invention may also or alternatively be a function of any of a variety of parameters, including those related to the target lumen.

[0040] The dispensed amount of 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 the liquid powder mixture from a reservoir. In some embodiments, a self-regulating pressurization system is used to draw a suitable amount of the liquid powder mixture from the reservoir.

[0041] As mentioned above, the method 240 of FIG. 2A further includes delivering an apportioned amount of the liquid powder mixture through at least a portion of the lumen to be cleaned. Generally, 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 such a manner (e.g., suitable size, suitable velocity, etc.) that provides a suitable physical interaction between the mixture and the wall of the lumen, meaning that undissolved powder will physically contact or impact the wall of the lumen to remove contaminants (e.g., biological contamination) therefrom. Of course, the apportioned amount of the liquid powder mixture may be delivered through the lumen in any suitable manner to enable cleaning of the lumen according to embodiments of the present invention.

[0042] In particular, method 240 can be repeated any number of times to facilitate cleaning of a lumen of a medical device. For example, FIG. 2B illustrates the delivery of one cleaning slug 248 (e.g., a proportioned amount of a liquid powder mixture) through a lumen 252 to remove contaminants from the walls of the lumen, with the general direction of travel of slug 248 represented by arrow 261. That is, as shown, lumen 252 has one or more contaminants 254 (e.g., biological contaminants) disposed on an interior surface / wall 256 of the lumen. Further, cleaning slug 248 is further shown being delivered through lumen 252 to physically interact with the walls of the lumen, thereby removing contaminants 254 therefrom. Cleaning slug 248 can be considered to be contained within a carrier fluid, which in this example includes air (represented by arrow 263).

[0043] In general, cleaning slugs presented herein, such as cleaning slug 248, may have different configurations / configurations. For example, in certain embodiments, cleaning slugs presented herein may be relatively single / single masses (e.g., potentially substantially occluding the lumen while traveling therethrough), sometimes referred to herein as "single slugs." However, in other embodiments, cleaning slugs may be "aggregates" or "clusters" of smaller clumps / groups, sometimes referred to herein as "cluster slugs," that travel through the lumen as a loose group (e.g., may not occlude the lumen while traveling therethrough). Figure 2B illustrates a schematic example where slug 248 is a cluster slug.

[0044] In certain embodiments, cleaning slugs can transition between different forms during the slug's life cycle. For example, a slug may be distributed (initially generated) as a single slug, but then transition to a cluster slug. This transition can occur prior to entering the lumen (e.g., in the delivery chamber) and / or while traveling through the lumen.

[0045] As noted above, FIG. 2B generally illustrates the delivery of a cleaning slug 248 through lumen 252. In certain instances, FIG. 2B represents a first stage / phase of the cleaning process, while FIG. 2C represents a second stage / phase of the cleaning process. More specifically, after the cleaning slug 248 is delivered through lumen 252 (as in FIG. 2B), a fluid flow is delivered through lumen 252 without any slug. In the example of FIG. 2C, the fluid flow is comprised of water 265, with the general direction of travel again represented by arrow 261. In certain instances, the fluid flow (e.g., water 265) is configured to remove residue 247 from the lumen. Residue 247 may include, for example, remnants of portions of contaminants 254 and / or portions of slugs 248, which may remain on the walls of lumen 252 after the passage of the slugs (e.g., the slugs may break up into different clusters, portions of which remain on the walls of lumen 252). If present, portions of slugs 248 that may remain on the walls of lumen 252 may aid in the cleaning process as these portions are swept through lumen 252 by the fluid flow.

[0046] Figures 2B and 2C generally illustrate an arrangement in which the second stage (fluid flow) is interspersed between the delivery of the cleaning slugs. That is, in the embodiments of Figures 2B and 2C, the delivery of each cleaning slug is followed by a fluid-only flow. In certain alternative embodiments, multiple slugs may be delivered through the lumen without separation (e.g., without a fluid-only flow), either simultaneously or sequentially.

[0047] 2B illustrates the delivery of one cleaning slug 248, it should be understood that in different embodiments, any number of cleaning slugs may be delivered through the lumen. In general, the use of a series of discrete / separate cleaning slugs 248, as opposed to a single bulk stream, can allow the separate cleaning slugs to maintain sufficient kinetic energy to pass through the lumen at a velocity that allows particles carrying the slugs to favorably interact with the lumen wall to remove contaminants therefrom.

[0048] As mentioned above, the luminal cleaning process as described above with reference to Figures 2A, 2B, and 2C can be implemented in a number of different ways with a number of different lumens. For context, one particular exemplary implementation will be described with reference to cleaning at least a portion of the endoscope 100 of Figure 1A.

[0049] More specifically, in one exemplary cleaning process / cycle, one (1) cleaning slug is fired / ejected into the water jet channel 128 via the water jet connector 138, then nine (9) cleaning slugs are fired into the biopsy / aspiration channel 122 via the suction connector 137, then one (1) cleaning slug is fired into the water jet channel 128 via the water jet connector 138, then three (3) cleaning slugs are fired into the distal section 122B of the biopsy / aspiration channel 122 via the biopsy valve 128, then one (1) cleaning slug is fired into the water jet channel 128 via the water jet connector 138, then nine (9) cleaning slugs are fired into the biopsy / aspiration channel 122 via the suction connector 137. The cleaning cycle may further include firing / shooting six (6) cleaning slugs into air channel 124 via air connector 143 and firing (e.g., in parallel) six (6) cleaning slugs into water channel 126 via water connector 141. The firing of the cleaning slugs in each target lumen may be followed by a fluid flow as described above with reference to FIG. 2C. The cleaning slugs and fluid flow may be delivered through one or possibly multiple connectors (e.g., one connector for the air pipe and one connector for the air / water bottles).

[0050] In a particular example, about 180-200 grams of slurry can be used to clean a typical flexible GI endoscope. For example, about 80-100 grams can be used to clean a relatively large channel (e.g., the aspiration / biopsy channel 122) for a total of 21 shots with a delay of about 15 seconds between each shot. For a relatively small channel (e.g., the air / water channel), the process can use about 60-80 grams for a total of 12 shots with a delay of about 30 seconds between each shot. For other smaller channels (e.g., the water jet channel 128), the process can use about 10-20 grams for a total of 3 shots with a delay of about 30 seconds between each shot. Again, as described above with reference to FIG. 2C, each of these channels can also receive a subsequent fluid flow (e.g., after each cleaning slug).

[0051] As discussed above, the cleaning slug is delivered to the target lumen at a velocity suitable / sufficient to remove contaminants from the walls of the target lumen. The velocity of the cleaning slug may vary based on, for example, the attributes of the target lumen, the attributes of the contaminant removal fluid composition (slurry) used to form the slug, etc. In one illustrative example, the slug velocity for a relatively large lumen may be about 1000 mm / sec.

[0052] Additionally, the cleaning slugs can be delivered within certain pressure and fluid flow rate (air) ranges. In certain examples, the cleaning slugs can be delivered at pressures up to about 26 psi (air, note that this is regulated by the PPR as described below), up to about 24 psi (water), etc. Exemplary air flow rate metrics can include about 50 SLPM (large channel unloaded), about 11-17 SLPM (large channel during dosing), about 7-10 SLPM (large channel during full load), about 5-7 SLPM (small channel unloaded), and about 0.1 SLPM (small channel during full load). It should be understood that these ranges and values ​​are merely exemplary, and that aspects of the technology presented herein are in no way limited to these particular ranges and values.

[0053] FIG. 3 illustrates another method 358 for cleaning a target lumen, according to an embodiment of the present invention. As shown in the figure, the method 358 begins at 360 with providing a holding chamber containing powder. This can be accomplished in any of a variety of ways. For example, in some embodiments, a dedicated system for performing cleaning includes a "durable" chamber configured to receive the powder, e.g., via a cartridge, whereby the provision can be accomplished. Such a chamber can be considered "durable" as long as it is intended to be operable for the life of the system. In certain embodiments, a dedicated system for performing cleaning is configured to receive a disposable / consumable chamber that essentially contains the powder, thus, the provision can be accomplished. Such disposable / consumable chambers can be provided with enough powder to allow for multiple cleaning cycles after which they are "consumed" (depleted). The user can then obtain additional disposable / consumable chambers that originally contained the powder.

[0054] The method 358 further includes, at 362, adding liquid to the holding chamber to generate a fluid liquid-powder mixture. In certain embodiments, the liquid can come from a liquid source dedicated to servicing only the holding chamber. In further embodiments, the liquid source is used to both provide liquid to the holding chamber and to provide liquid that acts as a carrier fluid. Such a configuration can allow for a more efficient design.

[0055] The method 358 further includes providing a portion of the liquid powder mixture to a delivery chamber at 364. As previously mentioned, this can be accomplished in any of a variety of ways. For example, a valve can be used to provide the portion of the liquid powder mixture to the delivery chamber. In certain embodiments, the size of the portion of the liquid powder mixture provided to the delivery chamber is a function of the characteristics of the target lumen to be cleaned. This aspect is described further below.

[0056] The method 358 further includes delivering a portion of the fluid liquid powder mixture to the target lumen using a carrier fluid at 366. In practice, the fluid liquid powder mixture can be made to interact with the lumen (similar to "brushing" it). As shown, this providing and subsequent delivery of the fluid liquid powder mixture to the delivery chamber can be repeated multiple times to achieve cleaning of the lumen.

[0057] It should be understood that a system for cleaning a lumen of a medical device according to embodiments presented herein can take any of a number of different forms / configurations. Generally, however, the system includes a holding chamber for generating / containing a powder and / or a liquid powder mixture, and a mechanism for delivering a portion of the liquid powder mixture to a target lumen. Figures 4, 5, and 6 illustrate various aspects of an exemplary system that may be implemented according to embodiments presented herein.

[0058] Referring initially to FIG. 4, a system 470 for cleaning a lumen of a medical device using a liquid powder mixture is shown, according to embodiments presented herein. More specifically, the system 470 includes a holding chamber 472 for generating / containing a liquid powder mixture 474. In the illustrated embodiment, the holding chamber 472 includes a powder used to form the liquid powder mixture. For example, the holding chamber 472 may be a consumable component of the system 470 and may be replaced when its contents have been used. The holding chamber 472 interfaces with an inlet valve 476 for receiving liquid from a liquid source 478. A relief valve 480 may be used to release pressure generated during generation of the mixture. As can be appreciated, the liquid powder mixture 474 can be generated using any suitable components. For example, in a particular embodiment, the powder provided to the holding chamber 472 is sodium bicarbonate and the liquid source 478 is a water source. Of course, it can be appreciated that the holding chamber 472 can receive liquid and powder in any of a variety of ways according to embodiments of the present invention. For example, in some embodiments, the chamber is configured to receive powder from a powder reservoir, e.g., a sodium bicarbonate cartridge. In some embodiments, a pump is used to provide liquid to the chamber instead of directly using a valve to so provide the liquid. In some embodiments, the holding chamber 472 can include a mechanism (not shown) to facilitate mixing of the received powder and liquid. For example, a stirring or agitation mechanism can be implemented to facilitate mixing.

[0059] The system 470 further includes a delivery mechanism 482 for delivering a portion of the liquid powder mixture to the target lumen. In the illustrated embodiment, the delivery mechanism is in the form of a collection of a carrier fluid source 484, a first valve 486, and a second valve 488. As can be appreciated, the carrier fluid 484 can be made to flow through the target lumen via the valve 486, and a portion of the liquid powder mixture can be contained within this flow. It is noted that any suitable carrier fluid may be implemented. For example, the carrier fluid source may include at least one of air, water, ethanol, nitrogen, and carbon dioxide. In the illustrated embodiment, the valve 420 is configured to implement the amount of the liquid powder mixture contained within the carrier fluid. For example, the valve 482 may be opened to the holding chamber 472, and the holding chamber 472 may be pressurized via the liquid source 478 and the valve 476, thereby resulting in the portion of the liquid powder mixture being delivered to the delivery mechanism 482. Of course, it is understood that any suitable mechanism for implementing the amount contained within the carrier fluid may be applied in accordance with embodiments of the present invention.

[0060] Although one system architecture for cleaning a medical device having a lumen has been illustrated, it should be understood that the described concepts may be implemented in any of a variety of ways in accordance with embodiments of the present invention. For example, in some embodiments, a carrier fluid source is additionally used to generate the liquid powder mixture, and thus a separate liquid source (e.g., 478) may not be necessary. In some embodiments, multiple selectable carrier fluid sources may be implemented. Thus, for example, in some embodiments, an air source and a water source may each provide a carrier fluid for delivering the liquid powder mixture to the lumen, and a water source may be further used to facilitate generation of the liquid powder mixture. In some embodiments, the chamber may include a separate pressure source to facilitate delivery of a portion of the liquid powder mixture to the delivery mechanism, such that a liquid source is not required to facilitate such delivery.

[0061] In certain embodiments, separate chambers are implemented to facilitate propulsion of the mixture through the lumen to be cleaned. For example, FIG. 5 illustrates a system 570 including a holding chamber 572 for generation / containment of a liquid powder mixture 574 and a delivery chamber 583 for developing the velocity of the liquid powder mixture for subsequent delivery through the lumen. In the illustrated embodiment, a powder source 581 is coupled to the holding chamber 572 via a valve 580, and a liquid source 578 is coupled to the holding chamber 572 via a valve 576. The powder source 581 may be, for example, a cartridge, and the liquid source 578 may be, for example, pressure-regulated tap water.

[0062] As mentioned above, the system 570 also includes a delivery chamber 583 for delivering a portion of the liquid powder chamber to the target lumen to be cleaned.

[0063] As shown, delivery chamber 583 is coupled to each of two carrier fluid sources 584A and 584B via respective valves 586A and 586B. For example, air and water may serve as carrier fluids in the illustrated system. The amount of liquid powder mixture contained in the carrier fluid may be controlled by valve 588.

[0064] In general, one exemplary purpose of the delivery chambers presented herein, such as delivery chamber 583, is to create an air gap between the slug source (holding chamber 572) and the target lumen to be cleaned. The creation of the air gap provides a location (e.g., delivery chamber 583) where the cleaning slugs can be accelerated to enter the target lumen at a suitable (e.g., selected) velocity. That is, delivery chamber 583 provides an area where system 570 uses one or more fluids (e.g., air and / or water) to accelerate the cleaning slugs. Without delivery chamber 583, the cleaning slugs would enter the target lumen at the same velocity as they exit holding chamber 571, which would likely be too slow to effectively clean the target lumen (e.g., delivery chamber 583 allows system 570 to provide sufficient kinetic energy to propel the slugs through the entire lumen at a desired velocity).

[0065] 5, the delivery chamber 582 defines a frusto-conical shape that can be beneficial in several ways. For example, such a geometric shape can aid in the flow of the "slurry" and, for example, direct it toward the target lumen. Additionally, the frusto-conical shape can generate a "vortex" of the carrier fluid within the delivery chamber 582.

[0066] Although a particular configuration is illustrated, it can be understood that systems implementing separate delivery chambers in accordance with embodiments of the invention can be implemented in any of a variety of ways, for example, in some embodiments, the delivery chambers are coupled to only a single carrier fluid source.

[0067] While the embodiment illustrated in Figure 5 shows an architecture in which the powder may be provided to the chamber, for example, via a cartridge, in some embodiments, the chamber may be a consumable component, as previously discussed. Thus, Figure 6A illustrates a system 670A for cleaning a lumen of a medical device using a consumable component and a delivery chamber.

[0068] In particular, system 670A includes a holding chamber 672 in the form of a consumable component that contains powder. A liquid powder mixture 674 can be generated / contained within holding chamber 672 using liquid from carrier fluid source 684A. System 670A further includes a carrier fluid source 684B that can contain a gaseous carrier fluid. Similar to system 570 of FIG. 5, system 670A further includes a delivery chamber 683 operable to deliver the liquid powder mixture to a lumen for washing. In certain embodiments, a pump 690 is also provided between holding chamber 672 and delivery chamber 683.

[0069] The use of a chamber in the form of a consumable component, as shown in FIG. 6A, can be advantageous insofar as it simplifies the design and improves user operability. For example, the use of such a configuration can eliminate the need for a separate powder handling mechanism. While the illustrated embodiment shows a chamber containing a powder that is subsequently hydrated, in some embodiments, the chamber comprises a pre-made liquid-powder mixture. For example, a chamber containing a powder that is insoluble in a corresponding liquid may be implemented. The insolubility of the powder in the respective liquid may allow the chamber to have a suitable shelf life and thus be commercially viable.

[0070] 6B illustrates another system 670B for cleaning a lumen of a medical device using a consumable component and a delivery chamber. System 670B is similar to system 670A of FIG. 6A and also includes a holding chamber 672 in the form of a consumable component into which powder is provided, where a liquid powder mixture 674 can be generated / contained within the holding chamber 672 using liquid from a carrier fluid source 684A. System 670B further includes a carrier fluid source 684B that can contain a gaseous carrier fluid.

[0071] However, unlike system 670A of Figure 6A, system 670B includes two delivery chambers 683, each operable to deliver a liquid powder mixture to a target lumen for cleaning. Also shown in Figure 6B are two pumps 690 disposed between the holding chamber 672 and the corresponding delivery chambers 683. In certain examples, system 670B can be used to clean two lumens simultaneously (e.g., simultaneously, sequentially, etc.).

[0072] In certain embodiments, the systems presented herein further include at least one distribution manifold that can be coupled to multiple ports / channels / lumens of the medical device to be cleaned. In some embodiments, a single delivery chamber is coupled to a single port of the medical device. Each of the multiple delivery chambers can be simultaneously coupled to separate ports of a single medical device. Similarly, in some embodiments, the system can include a holding chamber and multiple delivery chambers, and the holding chamber can provide cleaning slugs to each of the multiple delivery chambers.

[0073] In certain embodiments of the present invention, consumable chambers are implemented that contain components used for cleaning for use in a system for cleaning medical devices having a lumen (e.g., as described elsewhere herein). In this context, "consumable chambers" can be understood as not intended to be permanent fixtures of the system with which they interact. For example, such consumable chambers can be acquired and made to interface with the respective cleaning system, and when the components therein are exhausted by the cleaning system, they can be discarded or otherwise sent to a center for reprocessing. The user can then acquire another consumable chamber that requires further cleaning. The use of such "consumable chambers" can significantly improve the efficiency and operability of the disclosed cleaning system.

[0074] Thus, FIG. 7 illustrates a consumable holding chamber 772 housing at least one component for use in a system for cleaning a lumen of a medical device, according to an embodiment of the present invention. In particular, the consumable holding chamber 772 is illustrated as including at least one component 771 for use in a cleaning system (such as, for example, any of those described above). For example, in certain embodiments, the consumable holding chamber 772 comprises sodium bicarbonate, and a cleaning system that interfaces with the consumable chamber can then provide water to the holding chamber 772 to generate a sodium bicarbonate water mixture that can be used for cleaning. In some embodiments, the consumable holding chamber 772 originally includes a liquid powder mixture (e.g., prior to interfacing with the respective cleaning system). For example, certain liquid powder mixture combinations may have a more durable shelf life (e.g., compared to a mixture of sodium bicarbonate and water), and therefore it may be more commercially viable for the consumable chamber to include such a liquid water mixture. The consumable holding chamber 772 is further illustrated as including two interfaces 787, 789 for engaging with a cleaning system. For example, interface 787 can allow a irrigation system to provide liquid to holding chamber 772 via a valve to generate a liquid powder mixture used for irrigation. Interface 787 can additionally / alternatively allow a irrigation system to withdraw a portion of the liquid powder mixture from the chamber for subsequent delivery to the target lumen. The illustrated consumable chamber further includes an interface 789 for engaging with the irrigation system. In particular, 789 is shown to allow the consumable chamber to interface with a relief valve, which can help direct fluid flow to and from the consumable chamber.

[0075] Although a particular configuration for the consumable chamber is illustrated, it should be understood that embodiments of the present invention may be implemented in any of a variety of ways in accordance with embodiments of the present invention. For example, in some embodiments, a third interface is included for engaging a dedicated liquid source for the creatine of the liquid powder mixture. In some embodiments, the respective valves may be integrated with the consumable chamber. In general, the disclosed concepts may be implemented in any of a variety of ways in accordance with embodiments of the present invention.

[0076] In certain embodiments, a method of cleaning a lumen of a medical device includes determining the fluid resistance / impedance (and / or conductance) of a target lumen to be cleaned and using the determined fluid resistance to inform the cleaning method. For example, different lumens may have different characteristics, such as geometry, and enhancing the effectiveness / efficiency of cleaning may be a function of these particular characteristics. Fluid resistance may be a suitable indicator of these characteristics. In general, it may be understood that fluid resistance is related to how restrictive a lumen is to flow.

[0077] For example, determining the fluid resistance of a target lumen of a medical device can include flowing a fluid having a known specific gravity through the target lumen of the medical device and measuring the flow rate and / or pressure differential of the fluid flowing through the target lumen of the medical device. These parameters can then be used to calculate the fluid resistance of the target lumen. Such methods are merely exemplary, and other techniques can alternatively be used to determine the fluid resistance of the target lumen (e.g., determining the fluid resistance directly from the known dimensions of the target lumen).

[0078] As discussed above, the fluid resistance of the target lumen can be used to control the distribution of the liquid powder mixture and / or the delivery of the distributed amount. For example, in one configuration, the aspiration / biopsy channel of an endoscope is the target lumen to be cleaned. The aspiration / biopsy channel is a relatively large lumen, and the dimensions of the channel can be used to establish the relatively large size of the distributed amount. Conversely, the air-water channels of an endoscope are relatively small internal lumens, and the dimensions of these channels can be used to establish the relatively small size of the distributed amount.

[0079] In certain examples, the fluid resistance of the target lumen can be used (e.g., periodically, continuously, etc.) to update cleaning parameters accordingly (e.g., in real time) to improve the effectiveness of cleaning. For example, the frequency of delivery of the apportioned amount can be informed by the determined fluid resistance. Further details regarding techniques for determining the fluid resistance of the target lumen can be found in Australian Patent Application No. 2021 / 901734, entitled "Systems and Methods for the Identification, Evaluation, and / or Closed-Loop Cleaning of lumens," filed June 9, 2021, the contents of which are incorporated herein by reference, and in a concurrently filed patent application entitled "Systems and Methods for the Identification, Evaluation, and / or Closed-Loop Reprocessing of Lumens," the contents of which are also incorporated herein by reference.

[0080] It should be understood that the concepts described above may be applied in any of a variety of ways in accordance with embodiments of the present invention. However, FIGURE 8 illustrates one exemplary system 870 for irrigating a lumen that may incorporate certain elements of the concepts described above in accordance with embodiments of the present invention. For ease of explanation, system 870 will be generally described with reference to endoscope 100 of FIGURE 1.

[0081] More specifically, system 870 includes a control subsystem 817, a holding subsystem 895, and a delivery subsystem 897. Holding subsystem 895 includes, among other elements, a holding chamber 872 for mixing powder and liquid to form a liquid-powder mixture 874. Delivery subsystem 897 includes, among other elements, a delivery chamber 883 for generating a fluid flow for propelling a cleaning slug through at least a portion of a channel, such as channel 122, 124, 126, or 128, of endoscope 100. In the illustrated embodiment of FIG. 8, delivery chamber 883 includes an interior volume that can be characterized as having a frusto-conical shape such that fluid flow inlets from one or more sides generate a fluid flow that increases in velocity as the fluid approaches the narrow end of the frusto-cone. However, it should be understood that the use of a frusto-conical shape, while potentially advantageous, is merely exemplary and that the delivery chamber can have any suitable geometric shape according to embodiments of the present invention. For example, in some embodiments, the delivery chamber can have a cylindrical form factor. In some embodiments, the delivery chamber can be characterized as having a hemispherical shape.

[0082] Returning to the example of Figure 8, a slurry conduit 889 fluidly connects holding chamber 872 to delivery chamber 883, with a slurry valve 892 preferably being provided within the slurry conduit. Of course, it should be understood that any suitable configuration that allows a liquid powder slurry to be developed, apportioned into a cleaning slug, and delivered to a lumen of a medical device at a suitable rate can be implemented in accordance with embodiments of the present invention.

[0083] In the illustrated embodiment of FIG. 8, the delivery chamber 883, in turn, is fluidly connectable to at least one of the channels (e.g., 122, 124, 126, or 128) of the endoscope 100. In the illustrated embodiment, a distribution manifold 894 is provided between the delivery chamber and the endoscope channel, so that a channel, or a portion of a channel, can be selected for cleaning. In some embodiments, the delivery chamber can be associated with a single port of the medical device. In other embodiments, one holding chamber provides slurry to each of several delivery chambers, each of several delivery chambers being associated with a single port of the medical device. Of course, it should be understood that any suitable configuration that allows cleaning slugs of liquid powder slurry to be delivered at a suitable rate through the lumen of the medical device can be implemented in accordance with embodiments of the present invention.

[0084] In the illustrated embodiment of Figure 8, powder is provided to the holding chamber from a powder cartridge 896 via a powder conduit 898. Optionally, a powder valve 899 is positioned in the powder conduit 898 upstream of the inlet of the holding chamber 872 to seal the holding chamber from the powder cartridge. The holding chamber 872 also includes a relief valve 880 to allow evacuation of any air trapped during liquid filling.

[0085] Of course, it can be understood from the above description that the powder can be provided in any suitable manner to form a slurry in accordance with embodiments of the present invention. For example, in some embodiments, the powder cartridge may be omitted and the powder required for the cleaning process is simply placed in an available holding chamber. In a further, not shown, embodiment, the powder for one complete cleaning cycle is placed in a holding chamber in a pierceable powder pod.

[0086] In the illustrated embodiment, delivery chamber 883 includes a primary liquid port 801 and a primary gas port 803 to allow the inlet of liquid from a primary liquid source 884A and gas from a gas source 885A, respectively. Similarly, holding chamber 872 includes a secondary liquid port 805 and a secondary gas port 807 that are supplied from liquid source 844B and gas source 885B, respectively. In the illustrated embodiment, a vibrating motor 809 is provided and positioned proximate to the outlet of holding chamber 872 to facilitate discharge of the slurry or to assist in the mixing process, if desired.

[0087] In addition to the above, the system 870 of FIG. 8 includes an optical sensor 811 and a pressure sensor 813, as described in more detail below, to monitor the operation of the slurry generation and cleaning process. For example, the pressure sensor 813 can cooperate to detect whether the endoscope 100 is connected to the system and sense whether there is an occlusion in the system. In those circumstances, a fault condition will be generated by the control subsystem 817 (e.g., a computer control (not shown) for programmable control of the operation of various control valves, motors, and / or other pumping systems according to the methods of the proposed embodiments of the present invention). The control subsystem 817, which can be integrated with the system 870 or a separate computing device, can enable the system 870 to be programmed to clean various endoscopes or other medical devices available on the market to a sufficient degree to comply with various regulatory agencies and within an enhanced time to reduce device downtime. The user simply connects the system to an endoscope and invokes the required cleaning program. Of course, as can be understood, any suitable sensor and control subsystem can be implemented to affect the operation of the cleaning system according to the embodiments of the present invention.

[0088] Turning now specifically to the operation of system 870 of FIG. 8, the first step according to the illustrated embodiment of FIG. 8 may be for one or more target channels of endoscope 100 to be flushed with water and / or a combination of gas and water. This may be accomplished, for example, by first closing slurry valve 892. A flow of gas, such as compressed air, and water are then provided to delivery chamber 883 from primary liquid port 801 and gas port 803. The air and water mixture then enters each of the internal channels via distribution manifold 894 and exits through an exit point of the endoscope. It may be understood that channels may be flushed sequentially at several stages of a flush cycle and / or channels may be flushed simultaneously at several stages of a flush cycle. In other embodiments, the flushing step is omitted and the process begins with the first substantial cleaning step below.

[0089] As previously mentioned, a step of the cleaning process is obtaining (e.g., forming) a slurry mixture. In the example of FIG. 8, the slurry mixture is formed by feeding a certain amount of powder from a powder cartridge 896, as well as an appropriate amount of liquid, into the holding chamber 872, thereby generating a slurry mixture 874. The liquid can be fed into the holding chamber 872 from a primary liquid port 801 in the delivery chamber 883, which feeds up to the holding chamber 872 after opening the slurry valve, or directly from a secondary liquid port 805. During operation, the powder is mixed with the liquid to generate the slurry 874. The slurry mixture 874 can be formed naturally upon introducing the liquid into the holding chamber, or the vibration motor 809 can be activated to ensure that the slurry is mixed to the desired level. It is noted that it is not suggested that all powder dissolves in the liquid. To this end, the non-dissolving powder assists the cleaning function.

[0090] 8 is described with reference to an embodiment in which the powder is sodium bicarbonate and the liquid is water, however, other powders may be used to generate the slurry without departing from the scope of the invention. Similarly, other liquids besides water may be used without departing from the scope of the invention.

[0091] It should be appreciated that the slurry (liquid powder mixture) 874 can be generated in a variety of ways. For example, in one method, all control valves 815 at the output of the distribution manifold 894 are initially closed and no gas is provided to any of the chambers. The relief valve 880, slurry valve 892, and primary liquid port 801 are then opened to allow water to fill the delivery chamber 883. Once the delivery chamber is filled, the water enters the holding chamber 872 via the slurry conduit 889 and hydrates the powder from the bottom up. In this manner, a uniform slurry is formed without the need to use the vibrating motor 809. At some point during the filling of the delivery chamber 883, the secondary liquid port 805 may be opened, if desired, to fill the holding chamber 872 faster. Once the holding chamber is adequately filled with water, as determined, for example, by an optical sensor 811 in the relief valve, the primary and secondary liquid ports close.

[0092] Operation of system 870 also includes distributing slurry 874 and forming a washing slug. In one particular example, control subsystem 817 (e.g., a computing device) closes slurry valve 892 and opens at least one of control valves 815. Control subsystem 817 then commands system 870 to create a positive pressure differential between holding chamber 872 and delivery chamber 883 and then open slurry valve 892. The created positive pressure differential forces the flow of slurry already created in holding chamber 872 into delivery chamber 883. Slurry valve 892 then closes and stops the flow of slurry from holding chamber 872 to delivery chamber 883, thus defining a washing slug of slurry.

[0093] It can be appreciated that creating a pressure differential between the holding chamber 872 and the delivery chamber 883 can be accomplished in a variety of ways. For example, a positive pressure differential can be achieved by controlling the pressure of the gas or liquid using a pump, a pressure regulator, a proportional pressure regulator (PPR), or an electronic pressure regulator (EPR). For example, in one specific and exemplary configuration, the gas pressure can be controlled using two proportional pressure regulators, namely, a primary PPR 819 and a secondary PPR 821. The primary PPR 819 is positioned between the primary gas supply 885A and the primary gas port 803 and controls the gas pressure in the delivery chamber 883. The secondary PPR 821 is positioned between the secondary gas supply 885B and the secondary gas port 807 and controls the gas pressure of the holding chamber 872. The PPRs 819 and 821 are controlled by an automatic controller to create a selectable positive pressure differential between the holding chamber and the delivery chamber.

[0094] As described above, the system 870 delivers a cleaning slug (a proportioned amount of liquid powder mixture) through at least a portion of the channel of the endoscope 100 to be cleaned. The delivery of the cleaning slug to the endoscope channel can be triggered in a variety of ways. For example, before the proportioned liquid powder mixture is transferred to the delivery chamber 883, a carrier fluid from the primary gas source 884B is supplied to the delivery chamber 883 at a regulated pressure using the primary PPR 819. The carrier gas can generate a fluid flow in the delivery chamber 883 that propels the proportioned liquid powder mixture through a distribution manifold 894 to a selected internal channel of the endoscope 100, which has already selected one of the control valves 815 to be opened at this time (e.g., the cleaning slug is accelerated to an appropriate speed). Upon reaching the bottom of the delivery chamber 883, the cleaning slug exits the delivery chamber, enters the distribution manifold 894, and then enters the selected internal channel of the endoscope 100 at the appropriate speed. This process may be repeated multiple times for the internal channels of the endoscope 100 before moving on to the next internal channel closing one control valve 815 and opening another control valve 815 .

[0095] Another technique for delivering a washing slug of slurry to the target lumen of FIG. 8 uses a self-regulating bi-stable process. In such an example, carrier fluid from the primary gas supply 885B is again supplied to the delivery chamber 883 at a pressure regulated using the primary PPR 819. When the slurry valve 892 opens, a washing slug of slurry can be transferred to the delivery chamber 883. It can be appreciated that the transfer of the first washing slug can occur automatically (e.g., due to gravity) or can be assisted by the creation of a positive pressure difference between the holding chamber 872 and the delivery chamber 883. When used, the positive pressure difference can be brought about naturally by high air flow through the endoscope due to the low fluid resistance of the unobstructed lumen. When this washing slug blocks the outlet of the delivery chamber, the pressure in the delivery chamber 883 will increase due to the increased fluid resistance of the fluid path downstream of the delivery chamber. As a result, the holding chamber 872 and the delivery chamber 883 will settle at similar pressures, which in turn stops the additional flow of slurry to the delivery chamber. The cleaning slug then travels through the selected internal channel and then exits endoscope 100. As the cleaning slug of slurry exits the endoscope channel, the pressure in delivery chamber 883 drops due to the lower fluid resistance of the downstream fluid line and the limited flow rate of carrier gas. This results in a pressure differential between delivery chamber 883 and holding chamber 872. As a result, another cleaning slug of slurry is drawn from holding chamber 872. The newly drawn cleaning slug is again acted upon by the gas flow to propel it through delivery chamber 883, distribution manifold 894, and into the selected internal channel of endoscope 100.

[0096] Generally, the process will continue essentially automatically, with manifold 894 selecting which internal channel will receive the cleaning slug of slurry, as long as the flow of pressure regulated gas continues and the supply of slurry in the holding chamber does not terminate. More specifically, once the cleaning slug has cleaned through an internal channel, the control subsystem can change the state of control valve 815, and the process is repeated for one or more endoscope channels. In this variation, the process can be repeated multiple times through the same internal channel until a sufficient level of debris removal is achieved before transitioning to another channel.

[0097] By selecting appropriate parameters such as chamber size, amount of liquid, amount of powder, and gas pressure, the system can self-regulate and prevent blockage of the internal channels of the endoscope while cleaning the endoscope. In some embodiments, the size of the cleaning slug can be more purposefully varied by changing the gas pressure, amount of water, amount of powder, chamber size, etc.

[0098] In a variation of the above process according to a further embodiment, the slurry valve 892 and all control valves 815 associated with each connector 823 are initially closed. Similar to the previous techniques, once a slurry is formed in the holding chamber 872 using any of the previously described processes, a positive pressure differential is created between the holding chamber and the delivery chamber using primary and secondary proportional pressure regulators (PPRs), or other means such as an electronic pressure regulator (EPR). The slurry valve 892 then opens and the positive pressure differential draws a wash slug of slurry into the delivery chamber. The slurry valve then closes to stop the flow of slurry from the holding chamber to the delivery chamber, defining the wash slug of slurry. A pressure regulated gas, typically compressed air, is then introduced through the primary gas port 803 into the delivery chamber 883, again creating a flow of gas. However, unlike the previous method, the wash slug is held in the delivery chamber 883 until one of the control valves 815 in the distribution manifold 894 is opened. After a selectable time, one of the control valves 815 is opened and the cleaning slug is propelled at an appropriate velocity into the endoscope channel using pressurized air. By doing so, cleaning efficiency can be improved by providing better control over the size of the cleaning slug since the cleaning slug is fully defined within the delivery chamber before being propelled in its entirety rather than propelled in portions. The high velocity cleaning slugs of the described slurries can use their composition and velocity, for example, generated by pressurized gas, water, or a mixture of gas and water in the delivery chamber, to create a powerful physical cleaning action over the interior walls of the selected endoscope channel.

[0099] 9 illustrates another exemplary system 970 for irrigating a lumen that may incorporate certain elements of the concepts described above, in accordance with embodiments of the present invention. For ease of explanation, system 970 will be described generally with reference to endoscope 100 of FIG.

[0100] More specifically, system 970 includes a control subsystem 917, a holding subsystem 995, a first delivery subsystem 997(1), and a second delivery subsystem 997(2). The holding subsystem 995 includes, among other elements, a holding chamber 972 for mixing powder and liquid to form a liquid-powder mixture 974 (e.g., a consumable chamber), while each delivery subsystem 997(1) and 997(2) includes, among other elements, a delivery chamber 983 for generating a fluid flow for propelling a washing slug of slurry through at least a portion of a channel, such as channel 122, 124, 126, or 128 of endoscope 100. In the illustrated embodiment of FIG. 9, delivery chambers 983 each include an interior volume that can be characterized as having a shape like a truncated cone, such that fluid flow inlets from one or more sides generate a fluid flow that increases in velocity as the fluid approaches the narrow end of the truncated cone. However, it should be understood that the use of a frusto-conical shape, while potentially advantageous, is merely exemplary and that the delivery chamber can have any suitable geometric shape according to embodiments of the present invention. For example, in some embodiments, the delivery chamber can have a cylindrical form factor. In some embodiments, the delivery chamber can be characterized as having a hemispherical shape.

[0101] As discussed above, the holding subsystem 995 includes a holding chamber 972. In this example, the holding chamber 972 includes a consumable component with powder initially therein. A liquid is introduced into the holding chamber 972 for mixing with the powder to form a liquid-powder mixture 974. To this end, the holding chamber 972 includes a secondary liquid port 905 and a secondary gas port 907 that are fed from a liquid source 984B and a gas source 985B, respectively. In the illustrated embodiment, a vibration motor 909 is optionally provided and positioned proximate to the outlet of the holding chamber 972 to facilitate evacuation of the slurry or aid in the mixing process, if desired. The holding chamber 972 may also include a relief valve 980 to allow evacuation of any air trapped during liquid filling.

[0102] As previously mentioned, system 970 includes two delivery subsystems 997(1) and 997(2). In general, the two delivery subsystems 997(1) and 997(2) are substantially similar, and therefore the following description is provided with reference to delivery subsystem 997(1). It should be understood that this description applies equally to delivery subsystem 997(2).

[0103] As shown in the figure, delivery subsystem 997(1) comprises a pump 990 and a slurry valve 992 that fluidly connects holding chamber 972 to delivery chamber 983. Pump 990 and slurry valve 992 are operable to provide / deliver an apportioned amount of liquid powder mixture 974 (wash slugs) to delivery chamber 983. Of course, it should be understood that any suitable configuration that allows for a liquid powder slurry to be developed, apportioned to the wash slugs, and delivered to the delivery chamber may be used in accordance with embodiments of the present invention.

[0104] In the illustrated embodiment, the delivery chamber 983 includes one or more primary liquid ports 901 and one or more primary gas ports 903 to allow the inlet of liquid from a primary liquid source 984A and gas from a gas source 985A, respectively (e.g., there may be multiple outlets with the chamber 983 for each of liquid and gas delivery). The delivery chamber 983 is then fluidly connectable to at least one of the channels (e.g., 122, 124, 126, 128, etc.) of the endoscope 100. In the illustrated embodiment, a distribution manifold 994 is provided between the delivery chamber and the endoscope channel, so that a channel, or a portion of a channel, can be selected for cleaning. In some embodiments, the delivery chamber can be associated with a single port of the medical device. In other embodiments, one holding chamber provides slurry to each of several delivery chambers, and each of several delivery chambers is associated with a single port of the medical device. Of course, it should be understood that any suitable configuration can be implemented in accordance with embodiments of the present invention.

[0105] In addition to the above, the delivery subsystem 997(1) includes a pressure sensor 913 for monitoring the operation of the cleaning process, as described in more detail below. For example, the pressure sensor 913 may be used to detect whether the endoscope 100 is connected to the system and / or to sense whether there is any blockage in the system. In such a situation, a fault condition will be generated by the control subsystem 917 (e.g., computer control (not shown)) to programmably control the operation of various control valves, motors, and / or other pumping systems in accordance with the methods of the proposed embodiments of the present invention. The control subsystem 917, which may be integrated with the system 970 or a separate computing device, may enable the system 970 to be programmed to clean various endoscopes or other medical devices available on the market to an extent sufficient to comply with various regulatory agencies and within an enhanced time to reduce device downtime. The user simply connects the system to the endoscope and invokes the required cleaning program. Of course, as can be appreciated, any suitable sensor and control subsystem may be implemented to affect the operation of the cleaning system according to embodiments of the present invention.

[0106] Turning now specifically to the operation of the system 970 of FIG. 9, the first step according to the illustrated embodiment of FIG. 9 may be for one or more target channels of the endoscope 100 to be flushed with water and / or a combination of gas and water. This may be accomplished, for example, by first closing the slurry valve 992. A flow of gas, such as compressed air, and water are then provided to the delivery chamber 983 from the primary liquid port 901 and the gas port 903. The air and water mixture then enters each of the internal channels via the distribution manifold 994 and exits through an exit point of the endoscope. It may be understood that the channels may be flushed sequentially at several stages of the flush cycle and / or the channels may be flushed simultaneously at several stages of the flush cycle. In other embodiments, the flushing step is omitted and the process begins with the first substantial cleaning step below.

[0107] As previously mentioned, a step in the cleaning process is obtaining (e.g., forming) a slurry mixture. In the example of FIG. 9, the slurry mixture is formed by providing a quantity of fluid to mix with the powder in the holding chamber 972, thereby generating a slurry mixture 974. The liquid may be provided directly to the holding chamber 972 from a secondary liquid port 905 (or another liquid line). During operation, the liquid is mixed with the powder to generate the slurry 974. The slurry mixture 974 may form naturally upon introducing the liquid into the holding chamber, or the vibrating motor 909 may be activated to ensure that the slurry is mixed to a desired level. It is noted that it is not suggested that all powder dissolve in the liquid. To this end, the non-dissolving powder assists the cleaning function.

[0108] 9 is described with reference to an embodiment in which the powder is sodium bicarbonate and the liquid is water, however, other powders may be used to generate the slurry without departing from the scope of the invention. Similarly, other liquids besides water may be used without departing from the scope of the invention.

[0109] The operation of the system 970 also includes distributing the slurry 974 and forming a washing slug. In one particular example, the control subsystem 917 (e.g., a computing device) provides the washing slug to the delivery chamber 983 using the pump 990. In other embodiments (e.g., if the pump 990 is omitted), the control subsystem 917 closes the slurry valve 992 and opens at least one of the control valves 915. The control subsystem 917 then commands the system 970 to create a positive pressure differential between the holding chamber 972 and the delivery chamber 983 and then open the slurry valve 992. The created positive pressure differential pushes the flow of the slurry already created in the holding chamber 972 into the delivery chamber 983. The slurry valve 992 then closes and stops the flow of the slurry from the holding chamber 972 to the delivery chamber 983, thus defining a washing slug of slurry.

[0110] It can be appreciated that creating a pressure differential between the holding chamber 972 and the delivery chamber 983 can be accomplished in a variety of ways. For example, a positive pressure differential can be achieved by controlling the pressure of the gas or liquid using a pump, a pressure regulator, a proportional pressure regulator (PPR), or an electronic pressure regulator (EPR). For example, in one specific and exemplary configuration, the gas pressure can be controlled using two proportional pressure regulators, namely, a primary PPR 919 and a secondary PPR 921. The primary PPR 919 is positioned between the primary gas source 985A and the primary gas port 903 and controls the gas pressure in the delivery chamber 983. The secondary PPR 921 is positioned between the secondary gas source 985B and the secondary gas port 907 and controls the gas pressure of the holding chamber 972. The PPRs 919 and 921 are controlled by an automatic controller to create a selectable positive pressure differential between the holding chamber and the delivery chamber.

[0111] As described above, the system 970 delivers a cleaning slug (a proportioned amount of liquid powder mixture) through at least a portion of the channel of the endoscope 100 to be cleaned. The delivery of the cleaning slug to the endoscope channel can be triggered in a variety of ways. For example, before the proportioned liquid powder mixture is transferred to the delivery chamber 983, a carrier fluid from the primary gas source 984B is supplied to the delivery chamber 983 at a regulated pressure using the primary PPR 919. The carrier fluid (e.g., gas) can propel the proportioned liquid powder mixture to a selected internal channel of the endoscope 100 via a distribution manifold 994, which has already selected one of the control valves 915 to be opened at this time (e.g., the cleaning slug is accelerated to an appropriate speed). Upon reaching the bottom of the delivery chamber 983, the cleaning slug exits the delivery chamber, enters the distribution manifold 994, and then enters the selected internal channel of the endoscope 100 at the appropriate speed. The process may be repeated multiple times for the internal channels of the endoscope 100 before moving on to the next internal channel closing one control valve 915 and opening another control valve 915 .

[0112] Another technique for delivering a washing slug of slurry to the target lumen of FIG. 9 uses a self-regulating bi-stable process. In such an example, carrier fluid from the primary gas supply 985B is again supplied to the delivery chamber 983 at a pressure regulated using the primary PPR 919. When the slurry valve 992 opens, a washing slug of slurry can be transferred to the delivery chamber 983. It can be appreciated that the transfer of the first washing slug can occur automatically (e.g., due to gravity) or can be assisted by the pump 990 and / or the creation of a positive pressure differential between the holding chamber 972 and the delivery chamber 983. When used, the positive pressure differential can be brought about naturally by high air flow through the endoscope due to the low fluid resistance of the unoccluded lumen. When this washing slug blocks the outlet of the delivery chamber, the pressure in the delivery chamber 983 will increase due to the increased fluid resistance of the fluid path downstream of the delivery chamber. As a result, the holding chamber 972 and the delivery chamber 983 will settle at similar pressures, which in turn will stop the additional flow of slurry into the delivery chamber. The washing slug then proceeds through the selected internal channel and then exits the endoscope 100. As the washing slug of slurry exits the endoscope channel, the pressure in the delivery chamber 983 will drop due to the lower fluid resistance of the downstream fluid line and the limited flow rate of the carrier gas. This will result in a pressure differential between the delivery chamber 983 and the holding chamber 972. As a result, another washing slug of slurry will be drawn from the holding chamber 972. The newly drawn washing slug will again be acted upon by the gas flow to propel the slug through the delivery chamber 983, the distribution manifold 994, and into the selected internal channel of the endoscope 100.

[0113] Generally, the process will continue essentially automatically, with the manifold 994 selecting which internal channel will receive the cleaning slug of slurry, as long as the flow of pressure regulated gas continues and the supply of slurry in the holding chamber does not terminate. More specifically, once the cleaning slug has cleaned through an internal channel, the control subsystem can change the state of the control valve 915, and the process is repeated for one or more endoscope channels. In this variation, the process can be repeated multiple times through the same internal channel until a sufficient level of debris removal is achieved before transitioning to another channel.

[0114] By selecting appropriate parameters such as chamber size, amount of liquid, amount of powder, and gas pressure, the system can self-regulate and prevent blockage of the internal channels of the endoscope while cleaning the endoscope. In some embodiments, the size of the cleaning slug can be more purposefully varied by changing the gas pressure, amount of water, amount of powder, chamber size, etc.

[0115] In a variation of the above process according to a further embodiment, the slurry valve 992 and all control valves 915 associated with each connector 923 are initially closed. Similar to the previous techniques, once a slurry is formed in the holding chamber 972 using any of the previously described processes, a positive pressure differential is created between the holding chamber and the delivery chamber using primary and secondary proportional pressure regulators (PPRs), or other means such as an electronic pressure regulator (EPR). The slurry valve 992 then opens and the positive pressure differential draws a wash slug of slurry into the delivery chamber. The slurry valve then closes to stop the flow of slurry from the holding chamber to the delivery chamber, defining the wash slug of slurry. A pressure regulated gas, typically compressed air, is then introduced through the primary gas port 903 into the delivery chamber 983, again creating a flow of gas. However, unlike the previous method, the wash slug is held in the delivery chamber 983 until one of the control valves 915 in the distribution manifold 994 is opened. After a selectable time, one of the control valves 915 is opened and the cleaning slug is propelled at an appropriate velocity into the endoscope channel using pressurized air. By doing so, cleaning efficiency can be improved by providing better control over the size of the cleaning slug because the cleaning slug is fully defined within the delivery chamber before being propelled in its entirety rather than propelled in portions. The high velocity cleaning slugs of the described slurries can use their composition and velocity, for example, generated by pressurized gas, water, or a mixture of gas and water in the delivery chamber, to create a powerful physical cleaning action over the interior walls of the selected endoscope channel.

[0116] It will be appreciated that the cleaning system and method can provide a means of efficiently cleaning the internal channels of a medical device. The degree of contamination within the medical device after cleaning can meet all relevant standards and be substantially better than using prior art means. Once the cleaning process is completed, the internal channels can be flushed by flowing water and / or gas through each internal channel in a manner similar to the flushing process described above. In certain embodiments, the cleaning process can be substantially automatic after initial setup and its operation can be very simple for the operator. Advantageously, using computer control of all valves, ports, and pumps, cleaning times can be optimized to minimize downtime of the medical device.

[0117] As mentioned above, the luminal lavage system according to the embodiments presented herein can include or be controlled by a control subsystem. Figure 14 is a block diagram illustrating an exemplary computing device 1417 configured to operate as a control subsystem for the luminal lavage system according to certain embodiments presented herein. The computing device 1417 can include, for example, a personal computer, a server computer, a handheld device, a laptop device, a multiprocessor system, a microprocessor-based system, a programmable consumer electronics (e.g., a smartphone), a network PC, a minicomputer, a mainframe computer, a tablet, a remote control unit, a distributed computing environment including any of the above systems or devices, and the like. The computing device 1417 can be a single virtual or physical device operating in a network environment via a communication link to one or more remote devices, such as an implantable medical device or an implantable medical device system.

[0118] In its most basic configuration, computing device 1417 includes at least one processing unit 1425 and memory 1427. Processing unit 1425 includes one or more hardware or software processors (e.g., central processing units) that can retrieve and execute instructions. Processing unit 1425 can communicate with and control the performance of other components of computing system 1417.

[0119] Memory 1427 is one or more software or hardware-based computer-readable storage media operable to store information accessible by processing unit 1425. Memory 1427 can store, among other things, instructions executable by processing unit 1425 to implement applications or cause performance of operations described herein, as well as other data. Memory 1427 can be volatile memory (e.g., RAM), non-volatile memory (e.g., ROM), or a combination thereof. Memory 1427 can include temporary or non-temporary memory. Memory 1427 can also include one or more removable or non-removable storage devices. In some examples, memory 1427 can include RAM, ROM, EEPROM (electronically erasable programmable read-only memory), flash memory, optical disk storage, magnetic storage, semiconductor storage, or any other memory medium usable to store information for later access. In some examples, memory 1427 encompasses a conditioned data signal (e.g., a signal having one or more of its characteristics set or changed in such a manner as to encode information in the signal), such as a carrier wave or other transport mechanism, and includes any information delivery medium. By way of example and not limitation, memory 1427 can include wired media, such as a wired network or direct-wired connection, and wireless media, such as acoustic, RF, infrared, and other wireless media, or combinations of those media. In certain embodiments, memory 1427 comprises luminal lavage control logic 1429 that, when executed, enables processing unit 1425 to perform aspects of the presented techniques.

[0120] In the illustrated example, the system 1417 further includes a network adapter 1431, one or more input devices 1433, and one or more output devices 1435. The system 1417 may include other components such as a system bus, component interfaces, a graphics system, a power source (e.g., a battery), among other components. The network adapter 1431 is a component of the computing system 1417 that provides network access (e.g., access to at least one network). The network adapter 1431 may provide wired or wireless network access and may support one or more of a variety of communication technologies and protocols, such as Ethernet, cellular, BLUETOOTH, near field communication, and RF (radio frequency), among others. The network adapter 1431 may include one or more antennas and associated components configured for wireless communication according to one or more wireless communication technologies and protocols.

[0121] The one or more input devices 1433 are devices through which the computing system 1417 receives input from a user. The one or more input devices 1433 can include physically actuable user interface elements (e.g., buttons, switches, or dials), a touch screen, a keyboard, a mouse, a pen, and a voice input device, among other input devices. The one or more output devices 1435 are devices through which the computing system 1417 can provide output to a user. The output device(s) 1435 can include a display, one or more speakers, among other output devices.

[0122] 14 is merely exemplary, and it should be understood that aspects of the technology presented herein may be implemented in a number of different types of systems / devices. For example, the computing system 1417 may be a laptop computer, a tablet computer, a mobile phone, a surgical system, etc.

[0123] As discussed above, aspects of the technology presented herein are used to deliver so-called "cleaning slugs" (e.g., a proportioned amount of a liquid-powder mixture) to a target lumen to clear / clean the lumen of contaminants (e.g., biological contaminants). The size, flowability, velocity, and / or other characteristics / attributes of the cleaning slug are determined such that as the cleaning slug travels through the target lumen (i.e., the lumen to be cleaned), the cleaning slug interacts with (e.g., washes off) the walls of the target lumen to remove contaminants disposed on the interior surface / walls of the lumen.

[0124] In certain configurations, the cleaning slug attributes are determined based on the fluid resistance of at least a proximal portion of the target lumen to be cleaned. Fluid resistance is the tendency of a fluid pathway to resist flow of a given fluid due to the combined geometric and surface properties of the pathway. Examples of these properties include the dimensions of the target lumen to be cleaned, where the dimensions include one or both of the cross-sectional width (e.g., diameter) and length of the target lumen, the inner surface roughness of the lumen, and the like. As noted above, there are several different ways of calculating fluid resistance, which are described in further detail in Australian Patent Application No. 2021 / 901734, filed on June 9, 2021, entitled "Systems and Methods for the Identification, Evaluation, and / or Closed-Loop Cleaning of lumens," and in a concurrently filed patent application, filed on June 9, 2022, entitled "Systems and Methods for the Identification, Evaluation, and / or Closed-Loop Reprocessing of lumens." The contents of both of these applications are hereby incorporated by reference.

[0125] A particular lumen has a substantially constant internal dimension (cross-sectional width) along its elongated length. With a constant width lumen, the cleaning slug parameters determined at the time of delivery are generally sufficient to ensure adequate cleaning of the entire length of the lumen (i.e., from the proximal end to the distal end of the lumen). For example, with a constant width lumen, the fluidity and size of the lumen may remain substantially constant as the cleaning slug travels through the lumen. Furthermore, with the constant width of the lumen and the length of the lumen known, the cleaning slug may be delivered at a suitable velocity such that the cleaning slug reaches the distal end within an acceptable period of time and such that the velocity is optimal to remove contaminants from the walls of the lumen as the cleaning slug travels through the lumen.

[0126] However, not all medical device lumens have constant internal dimensions as well as their luminal length. Conversely, certain medical device lumens have variable internal dimensions, and certain lumens may merge together within the device, etc., to create compound fluid pathways for washing slugs. For example, FIG. 10 is a schematic diagram illustrating an example of compound fluid pathways resulting from variable internal dimensions of lumens, with reference to the endoscope 100 of FIG. 1, and more specifically, with reference to the air channel 124 and water channel 126 of the endoscope 100. The air channel 124 and water channel 126 are sometimes referred to collectively as the "air / water channels" of the endoscope 100. However, for ease of explanation, the air channel 124 and water channel 126 are described and referred to separately herein.

[0127] It should be understood that the specific references to air and water channels of an endoscope (e.g., air channel 124 and water channel 126) in Figure 10, as well as in other embodiments presented herein, are merely exemplary, and the invention is not limited to use with these particular lumens, or with endoscopes generally. Thus, it should be understood that the techniques presented herein can be used to clean different composite lumens of different devices / instruments used in any of a number of different applications.

[0128] 10 shows a schematic diagram of the air channel 124 and the water channel 126. As mentioned above, the air channel 124 includes two sections, designated proximal section 124A and distal section 124B, which are connected via the air / water valve 116, while the water channel 126 similarly includes two sections, designated proximal section 126A and distal section 126B, which are also connected via the air / water valve 116. The water channel distal section 126B joins the air channel distal section 124B at a location 130 within the distal end 102 of the endoscope 100.

[0129] As shown, proximal section 124A of air channel 124 and proximal section 126A of water channel 126 each extend from a connector end 104 (e.g., an air / water bottle connector and an air pipe connector) of endoscope 100 to air / water valve 116. Distal section 124B of air channel 124 and distal section 126B of water channel 126 each extend from air / water valve 116 to a location 130 within distal end 102 of endoscope 100. Location 130 is the location / point where distal section 124B of air channel 124 and distal section 126B of water channel join to form a joined outlet channel 137. As mentioned above, the proximal sections 124A and 126A of channels 124 and 126 may be referred to as being disposed within a universal cord section (cord) 132 of endoscope 100, while the distal sections 124B and 126B of channels 124 and 126 may be referred to as being disposed within an insertion tube 134 of the endoscope. For ease of illustration, biopsy / aspiration channel 122 and waterjet channel 128 have been omitted from FIG.

[0130] Also shown in Figure 10 are exemplary dimensions, including internal dimensions and lengths, for each section of the air channel 124 and water channel 126. It should be understood that the exemplary dimensions shown in Figure 10 are merely exemplary, and that the techniques presented herein can be used with a variety of other lumens having different dimensions.

[0131] 10, the proximal section 124A of the air channel 124 has an internal dimension (ID) (e.g., inner diameter) of about 2.0 millimeters (mm) and a length of about 1.5 meters (m), while the distal section 124B of the air channel 124 has an internal dimension of about 1.4 mm and a length of about 1.5 m. In addition, the proximal section 126A of the water channel 126 has an internal dimension (e.g., inner diameter) of about 2.4 mm and a length of about 1.5 m, while the distal section 126B of the water channel 126 has an internal dimension of about 1.4 mm and a length of about 1.5 m. The merged outlet channel 137 has an internal dimension of about 1.0 mm and a length of about 0.185 m.

[0132] In other words, the proximal sections 124A / 126A of the air and water channels 124 and 126 have larger internal dimensions than the internal dimensions of the corresponding distal sections 124B / 126B (e.g., the lumens narrow after the air / water cylinders 116). The variable internal dimensions of each of the air and water channels 124 and 126 create problems for flushing these lumens with flushing slugs delivered from the connector end 104 of the endoscope 100. As mentioned above, there may be multiple connectors, such as one connector for the air pipe and one connector for the air / water bottles. In particular, flushing slugs that have attributes suitable for flushing the larger proximal sections 124A and 126A of the air and water channels 124 and 126, respectively, may clog the narrower corresponding distal sections 124B and 126B (e.g., flushing slugs configured for 2.0 mm and 2.4 mm ID sections of the lumen are more likely to clog the 1.4 mm and 1.0 mm ID sections of the lumen). However, a cleaning slug configured to not clog the distal sections 124B and 126B of the air and water channels 124 and 126, respectively, may not be able to effectively clean the proximal sections 124A and 126A of the air and water channels 124 and 126, respectively (e.g., a cleaning slug configured for the 1.4 mm and 1.0 mm ID sections of the lumen will pass through the 2.0 mm and 2.4 mm ID sections without sufficiently interacting with the walls to provide the necessary actuation). Additionally, the confluence of the distal sections 124A and 126B and the small nozzle 139 at the distal end adds fluidic complexity.

[0133] Presented herein are techniques for flushing a fluidic compound lumen (such as a lumen channel having variable internal dimensions) via a flushing slug delivered from the proximal end of the lumen. These techniques are described in more detail with reference to Figures 11-15. For ease of explanation, the examples of Figures 11-15 will be described with reference to an air channel 124 and a water channel 126 of an endoscope 100.

[0134] 11, a configuration for flushing a fluidic compound lumen via adjustment of one or more attributes of a flushing slug during a flushing process (e.g., adjustment of flushing slug attributes at one or more locations between the proximal and distal ends of the lumen) is shown. More specifically, shown in FIG. 11 is an air / water cylinder 116 that defines an interior volume / opening 147 and portions of each of an air channel 124 and a water channel 126 connected to the air / water cylinder 116 (e.g., a portion of a proximal section 124A of the air channel 124, a proximal section 126A of the water channel 126, a distal section 124B of the air channel 124, and a distal section 126B of the water channel 126).

[0135] Also shown in FIG. 11 is a fluid delivery connector 151 configured to mechanically mate with the air / water valve 116. As shown in the figure, the fluid delivery connector 151 is configured to bifurcate the interior volume 147 of the air / water cylinder 116 into two chambers, referred to herein as an air chamber (or first chamber) 153 and a water chamber (or second chamber) 155. For example, as shown in FIG. 11, the fluid delivery connector 151 includes a separator portion 157 that fluidly isolates the air chamber 153 from the water chamber 155. The separator portion 157 can, for example, enable accurate occlusion detection of individual channels. Further aspects of exemplary fluid delivery connectors that can be used with embodiments of the present invention are described in more detail in International Patent Application No. PCT / AU2022 / 050547, entitled "Medical Device Port Connectors," filed on June 3, 2022, the contents of which are incorporated herein by reference.

[0136] In addition to bifurcating the interior volume 147 of the air / water cylinder 116, the fluid delivery connector 151 is also configured to separately deliver fluid (e.g., water) from the water chamber 155 to each of the air chambers 153. This fluid delivery from a fluid source (not shown in FIG. 11) is represented diagrammatically in FIG. 11 by arrows 157 and 159.

[0137] As shown in FIG. 11, the cleaning slug 1148A is delivered to the connector end of the proximal section 124A of the air channel 124. The cleaning slug 1148A is configured (e.g., sized) to physically interact with the walls of the proximal section 124A as the cleaning slug 1148A passes through the proximal section 124A. After a period of time, the cleaning slug 1148A reaches the air / water cylinder 116, and more specifically, the air chamber 153 formed by the fluid delivery connector 151. As mentioned above, as shown diagrammatically in FIG. 11, the proximal section 124A of the air channel 124 is relatively larger than the distal section 124B of the air channel. As a result, the cleaning slug 1148A may clog the air channel (e.g., get stuck in the distal section 124B) if it is allowed to continue into the distal section 124B of the air channel 124.

[0138] To address this issue, the techniques presented herein adjust the attributes of the cleaning slug 1148A in the air chamber 153 to form a conditioned / altered cleaning slug 1148B that is specifically configured (e.g., sized) to clean the smaller distal section 124B. In particular, in this example, fluid 157 is added to the air chamber 153 to, for example, adjust / alter (e.g., dilute) the flow properties of the cleaning slug 1148A to form a conditioned cleaning slug 1148B that is smaller than the cleaning slug 1148A and thus appropriately sized to clean the distal section 124B of the air channel 124. More generally, these actions change the powder to liquid ratio, where a higher liquid to powder ratio allows the cleaning slug 1148B to flow more easily through the narrower distal section 124B.

[0139] A similar approach has been applied to the water channel 126, where the cleaning slug 1149A is delivered to the connector end of the proximal section 126A of the water channel. The cleaning slug 1149A is configured (e.g., sized) so that the cleaning slug 1149A physically interacts with the wall of the proximal section 126A as it passes therethrough. After a while, the cleaning slug 1149A reaches the air / water cylinder 116, and more specifically, the water chamber 155 formed by the fluid delivery connector 151. As discussed above and shown diagrammatically in FIG. 11, the proximal section 126A of the water channel 126 is relatively larger than the distal section 126B of the water channel. As a result, the cleaning slug 1149A may clog the water channel (e.g., get stuck in the distal section 126B) if it is allowed to continue to the distal section 126B of the water channel 126.

[0140] As discussed above, to address this issue, the techniques presented herein adjust the attributes of the cleaning slug 1149A in the water chamber 155 to form a conditioned / modified cleaning slug 1149B that is specifically configured (e.g., sized) for cleaning the smaller distal section 126B. In particular, in this example, fluid 159 is added to the water chamber 155, e.g., to dilute the cleaning slug 1149A to form a conditioned cleaning slug 1149B that is smaller than the cleaning slug 1149A and thus appropriately sized for cleaning the distal section 126B of the water channel 126.

[0141] As discussed above, FIG. 11 generally illustrates a technique for conditioning (e.g., diluting) a relatively large cleaning slug before forcing the slug into a smaller section of the endoscope 100. The relatively large cleaning slug may clear contaminants from the proximal section (air in and water in sections) of the air and water channels before conditioning in the bifurcated air / water cylinder into a relatively small cleaning slug that may clear contaminants from the distal section of the air and water channels without clogging the relatively small distal section. In general, the conditioning applied to the cleaning slug may be determined based on the properties of the proximal section relative to the distal section of the lumen, for example, the relative internal dimensional difference between the proximal and distal sections of the lumen (e.g., based on the fluid resistance of the proximal section relative to the fluid resistance of the distal section). For example, a relatively large internal dimensional difference between the proximal and distal sections may require a relatively large conditioning (e.g., dilution) of the cleaning slug.

[0142] Figure 11 is described with reference to an air channel 124 and a water channel 126 of an endoscope 100, where the air channel 124 and the water channel 126 each include a proximal section and a distal section that are fluidly connected via an air / water cylinder 116. As mentioned above, it should be understood that this use is merely exemplary and that the embodiment of Figure 11 can be used with any of a number of different lumens.

[0143] Further, it should be understood that the technique of FIG. 11 can be used with any combination of fluidly connected lumens, not necessarily only lumens having proximal and distal sections. For example, the technique of FIG. 11 can be used with any combination of a first lumen (or first lumen section) that is fluidly connected to a second lumen (or second lumen section), e.g., where there is a change in internal dimensions between the first lumen and the second lumen. Furthermore, the first lumen (or first lumen section) and the second lumen (or second lumen section) can be fluidly connected directly in series (connected directly end-to-end) or can be indirectly connected in series via an intermediate component such as a fluid chamber (e.g., air / valve). For this purpose, the term "lumen" should be broadly understood as any fluid pathway that includes at least one fluid entry point and one or more fluid exit points. Applying the technique of FIG. 11, a irrigation slug delivered to and passing through a first lumen can be adjusted, for example, to an altered irrigation slug having a different size or flowability as it transitions into a second lumen.

[0144] 12 is a flow diagram of an exemplary method 1200 for irrigating a lumen, according to an embodiment of the present invention. The method 1200 begins at 1202, where an apportioned amount of liquid powder mixture (i.e., irrigation slug) is delivered through a first lumen portion, which may include a first lumen or a proximal section of the first lumen. At 1204, the apportioned amount of liquid powder mixture is adjusted (e.g., diluted) to form an altered apportioned amount of liquid powder mixture (e.g., an altered irrigation slug). At 1206, the altered apportioned amount of liquid powder mixture is delivered through a second lumen portion, which is fluidly connected to the first lumen portion. The second lumen portion may include a second lumen or a distal section of the first lumen.

[0145] 13 is a flow diagram of an exemplary method 1300 for cleaning a lumen, according to an embodiment of the present invention. The method 1300 begins at 1302, where a cleaning slug having a first configuration is delivered to a first lumen having proximal and distal ends and a change in internal dimensions between the proximal and distal ends. As described elsewhere herein, the "first lumen" need not be a single lumen, but rather can include two lumen sections that are fluidly connected to one another. At 1304, the cleaning slug is altered (e.g., diluted) to a second configuration at a location between the proximal and distal ends of the lumen.

[0146] In certain embodiments, for example, the fluidic complexities of channels having variable internal dimensions can be addressed by increasing the pressure used to propel the cleaning slug through the lumen. In particular, as the pressure is increased, the cleaning slug can be "forced" to conform to the size of the narrower lumen. Additionally, the use of increased pressure can ensure that the cleaning slug does not get stuck within the narrow lumen.

[0147] Certain aspects of the technology presented herein have been described with reference to various explanations of fluid mechanics, it being understood that these various explanations are provided for purposes of illustration and that the invention presented herein will function regardless of any true understanding of fluid mechanics.

[0148] As should be understood, although specific uses of the technology have been illustrated and described above, the disclosed technology can be used in a variety of devices, according to many examples of the technology. The above description does not imply that the disclosed technology is only suitable for implementation in systems similar to those shown in the figures. In general, additional configurations can be used to practice the processes and systems herein, and / or some described aspects can be excluded without departing from the processes and systems disclosed herein.

[0149] This disclosure describes some aspects of the technology with reference to the accompanying drawings, which illustrate only some of the possible aspects. However, other aspects may be embodied in many different forms and should not be construed as being limited to the aspects set forth herein. On the contrary, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the possible aspects to those skilled in the art.

[0150] As should be understood, 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. As such, additional configurations may be used to practice the methods and systems herein and / or some described aspects may be excluded without departing from the methods and systems disclosed herein.

[0151] According to certain aspects, systems and non-transitory computer-readable storage media are provided, the systems being configured with hardware configured to perform operations similar to the methods of the present disclosure, and the one or more non-transitory computer-readable storage media including instructions that, when executed by one or more processors, cause the one or more processors to perform operations similar to the methods of the present disclosure.

[0152] Similarly, where process steps are disclosed, those steps are described for purposes of illustrating the methods and systems and are not intended to limit the disclosure to the particular sequence of steps. For example, steps may be performed in a different order, two or more steps may be performed simultaneously, additional steps may be performed, and disclosed steps may be omitted without departing from the disclosure. Additionally, disclosed processes may be repeated.

[0153] Although specific aspects have been described herein, the scope of the technology is not limited to those specific aspects. Those skilled in the art will recognize other aspects or improvements that are within the scope of the technology. Thus, specific structures, operations, or media are disclosed as exemplary aspects only. The scope of the technology is defined by the following claims, and any equivalents therein.

[0154] It should also be understood that the embodiments presented herein are not mutually exclusive, and that various embodiments may be combined with other embodiments in any of a number of different ways.

Claims

1. A method for cleaning at least one internal lumen of a medical device, comprising: mixing a liquid with a powder to form a slurry; applying at least one flow of fluid to a portion of the slurry to propel the portion of the slurry through the at least one internal lumen of the medical device.

2. The method of claim 1, further comprising dispensing the mixture of the liquid and the powder to the portion based on at least the fluid resistance of at least a proximal section of the at least one internal lumen.

3. Mixing the liquid with the powder to form the slurry comprises: introducing the liquid into a consumable chamber that holds the powder, the method of claim 1.

4. Applying at least one flow of fluid to a portion of the slurry comprises: providing the portion of the slurry to a delivery chamber; applying at least one flow of fluid within the delivery chamber to accelerate the portion of the slurry before delivering the portion of the slurry to the at least one internal lumen, the method of claim 1.

5. Applying at least one flow of fluid within the delivery chamber comprises: applying a first flow of fluid within the delivery chamber and a second flow of fluid within the delivery chamber, the method of claim 4.

6. The method of claim 1, further comprising delivering a flow of fluid through the at least one internal lumen without any portion of the slurry.

7. further comprising mixing the powder with the liquid in at least one holding chamber, the at least one holding chamber being in fluid communication with one or more delivery chambers, the method of claim 1.

8. further comprising withdrawing at least a portion of the slurry from the at least one holding chamber into at least one of the one or more delivery chambers, the method of claim 7.

9. further comprising pumping at least a portion of the slurry from the at least one holding chamber into at least one of the one or more delivery chambers, the method of claim 7.

10. mixing the powder with the liquid to form the slurry includes providing an excess of powder relative to the liquid such that undissolved powder is suspended in the slurry, the method of claim 1.

11. mixing the powder with the liquid to form the slurry includes mixing sodium bicarbonate with water, the method of claim 1.

12. the at least one internal lumen is a fluid composite lumen having at least a first section having a first internal dimension and a second section fluidly connected to the first section, the second section having a second internal dimension smaller than the first internal dimension, the method of claim 1.

13. further comprising adjusting at least one attribute of at least a portion of the slurry at the transition from the first section of the at least one internal lumen to the second section of the at least one internal lumen, the method of claim 12.

14. the second section is connected to the first section via a fluid chamber, the method The method according to claim 13, comprising adjusting at least one attribute of the portion of the slurry in the fluid chamber. **Claim 15** Adjusting at least one attribute of the portion of the slurry comprises The method according to claim 13, comprising increasing the ratio of fluid to powder of the portion of the slurry. **Claim 16** The delivery chamber has a frustoconical inner surface, applying at least one flow of the fluid to the delivery chamber to accelerate the portion of the slurry, The method applying at least one flow of the fluid to the delivery chamber to rotate the portion along the frustoconical inner surface, The method according to claim 4, comprising. **Claim 17** The portion is delivered to a first section having a first configuration, and the method changing the portion to a second configuration at a transition from the first section of the at least one lumen to a second section of the at least one lumen, the method according to claim 12. **Claim 18** A system comprising at least one delivery chamber fluidly connected to at least one internal lumen of the device, at least one of a valve or a pump configured to provide a dispensed amount of a liquid powder mixture to the at least one delivery chamber, a delivery mechanism configured to apply at least one flow of fluid to the dispensed amount of the liquid powder mixture in the at least one delivery chamber to propel the dispensed amount of the liquid powder mixture through the at least one internal lumen. **Claim 19** The system according to claim 18, further comprising a control subsystem configured to determine the dispensed amount of the liquid powder mixture based on the fluid resistance of at least the proximal section of the at least one internal lumen.

20. The at least one delivery chamber includes a frustoconical inner surface, and the delivery mechanism is configured to apply at least one flow of the fluid within the at least one delivery chamber such that the dispensed amount of the liquid powder mixture spins along the frustoconical inner surface. The system according to claim 18.

21. At least one of the delivery mechanisms is configured to apply a first flow of fluid within the at least one delivery chamber and to apply a second flow of fluid within the delivery chamber. The system according to claim 18.

22. The system according to claim 18, further comprising a holding chamber, wherein the holding chamber is a consumable component configured to be mechanically detached from the system.

23. The system according to claim 18, further comprising a holding chamber, wherein the holding chamber is configured to hold powder, and the system is configured to deliver fluid to the holding chamber for mixing with the powder to form the liquid powder mixture.

24. The system according to claim 23, further comprising a motor for use in mixing the fluid with the powder to form the liquid powder mixture.

25. The system according to claim 18, wherein the system is configured to create a pressure differential between the holding chamber and the at least one delivery chamber to draw the dispensed amount of the liquid powder mixture from the holding chamber to the at least one delivery chamber.

26. The system according to claim 18, further comprising a distribution manifold fluidly connected between the at least one delivery chamber and the at least one internal lumen. **Claim 27** The system according to claim 18, wherein the delivery mechanism is configured to apply at least one flow of compressed air and water to the dispensed amount of the liquid powder mixture within the at least one delivery chamber. **Claim 28** The at least one internal lumen is a fluid composite lumen having at least a first section with a first internal dimension and a second section fluidly connected in series with the first section, the second section having a second internal dimension smaller than the first internal dimension, the system comprising a fluid delivery connector configured to deliver fluid at a transition of the at least one internal lumen from the first internal dimension to the second internal dimension, and to adjust at least one attribute of the dispensed amount of the liquid powder mixture at the transition of the at least one internal lumen from the first internal dimension to the second internal dimension. **Claim 29** The system according to claim 28, wherein the second section is connected to the first section via a fluid chamber, and the fluid delivery connector is configured to be fluidly connected to the fluid chamber. **Claim 30** The system according to claim 29, wherein the fluid delivery connector is configured to branch the fluid chamber into a first chamber and a second chamber, and the fluid delivery connector is configured to deliver the fluid separately to the first chamber and the second chamber. **Claim 31** The system according to claim 18, wherein the at least one delivery chamber includes a first delivery chamber and a second delivery chamber each separately fluidly connected to a holding chamber. Claim 32. The method according to claim 1, wherein the mixture of liquid and powder is dispensed to define at least one washing slug, and a portion of the slurry to which the at least one flow of fluid is applied is the washing slug.

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