Endoscope reprocessing system and technique for detecting disconnection of endoscope biopsy channel

Abstract

A method of detecting connectivity of a biopsy channel of an endoscope during an endoscope reprocessing procedure may involve connecting a fluid supply line to the biopsy channel and connecting a fluid detection sensor to a suction connector on the endoscope. After connection, fluid may be introduced into the fluid supply line connected to the biopsy channel of the endoscope. The reprocessing machine may determine whether the fluid supply line is properly connected to the biopsy channel of the endoscope based on detection of the fluid by the fluid detection sensor.

Description

[0001] Related applications

[0002] This application claims priority to U.S. Provisional Application 63 / 499,097, filed April 28, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This disclosure relates to systems and techniques for reprocessing reusable medical devices, and more specifically to systems and techniques for reprocessing endoscopes. Background Technology

[0004] An endoscope is a long, tubular optical instrument used as a viewing system to examine the interior of the body and, when used with attached instruments, for biopsies or surgical procedures. A purification system can be used to reprocess previously used medical devices, such as endoscopes, so that these devices can be reused for subsequent patients. During the purification process, the endoscope is inserted into the chamber of a purification machine, and the endoscope's internal channels are connected to the machine to receive cleaning and / or disinfecting agents. For example, the purification machine may provide a system of tubing, pumps, and valves for feeding cleaning and / or disinfecting agents to the endoscope placed in the chamber.

[0005] To ensure proper cleaning of the endoscope's internal channels or lumen, the endoscope's various channels are fluidly connected to a reprocessing machine via one or more releasable connectors. If the connectors fail to attach properly or otherwise fail to achieve a fluid seal, the endoscope's lumen may not receive the cleaning and / or disinfecting media required to ensure that the lumen's inner surfaces have been properly cleaned and / or disinfected. Therefore, configuring the reprocessing machine to assess the appropriateness of one or more fluid connections between the machine and the endoscope can be beneficial in detecting potential problems and helping to ensure proper reprocessing of the endoscope. Summary of the Invention

[0006] Generally, this disclosure relates to apparatus, systems, and techniques for reprocessing medical devices, and more specifically to endoscopes. Specifically, this disclosure describes apparatus, systems, and techniques for determining the appropriateness of the connection between an endoscope reprocessing machine and the biopsy channel of an endoscope in order to determine when the biopsy channel is properly connected for reprocessing operations.

[0007] While the specific style and configuration of an endoscope can vary, endoscopes are generally configured as flexible, tubular, elongated bodies that can be inserted into a patient's internal body cavity. The endoscope is divided into multiple discrete lumens or channels, such as one or more channels through which gases (e.g., air) and / or fluids (e.g., water) are delivered and / or aspirated. The endoscope may also have a biopsy channel through which medical accessories can pass, for example, to perform biopsies on tissue within the patient's body. The biopsy channel typically has a diameter significantly larger than the diameter of other channels on the endoscope, such as two to ten times larger. The biopsy channel extends from a biopsy port at the control section of the endoscope through to a biopsy channel exit at the end of the endoscope.

[0008] During reprocessing, the various channels of the endoscope can be fluidly connected to an endoscope reprocessing machine, referred to as an automated endoscope reprocessor (“AER”). The endoscope reprocessing machine can deliver one or more fluids (e.g., water, cleaning fluid, disinfectant fluid, air) to the various lumens of the endoscope during reprocessing. After the endoscope is connected to the reprocessing machine, the reprocessing machine can perform operations to check the integrity of the connection between the machine and the endoscope before performing cleaning operations. For example, the reprocessing machine can control the introduction of one or more fluids into fluid pathways designed to be fluidly connected to the corresponding lumen of the endoscope. The reprocessing machine can detect and / or measure the fluid draining from the opposite end of the lumen, and thereby determine whether the lumen is properly connected to the reprocessing machine or whether there appears to be a connection error (e.g., in this case, fluid is not flowing through the lumen and / or the amount of fluid flowing through the lumen does not correspond to the amount introduced into the lumen).

[0009] In practice, due to the large size of the biopsy channel, it can be difficult to determine whether the endoscope's biopsy channel is properly connected to the reprocessing machine. Depending on the configuration of the endoscope reprocessing machine, it typically monitors the flow rate of fluid exiting from the various lumens of the endoscope to assess the connection between the reprocessing machine and the endoscope. However, because the biopsy channel is so large, the fluid introduced into it can flow through the channel very rapidly (e.g., exiting from the outlet end in less than a second), making it difficult to accurately detect when the biopsy channel is correctly connected.

[0010] According to some specific embodiments of this disclosure, an automated endoscope reprocessing machine and associated techniques are described that determine whether the biopsy channel of an endoscope is properly connected to the reprocessing machine by detecting fluid flowing through different outlets of an endoscope fluidly connected to the biopsy channel. Specifically, in some examples, an automated endoscope reprocessing machine and associated techniques are described that involve connecting an endoscope's aspiration channel to a fluid detection sensor associated with the machine. The endoscope's biopsy channel may be connected to the automated endoscope reprocessing machine, and fluid is introduced into the biopsy channel to test whether the biopsy channel is properly connected to the machine. Exemplary fluids include gases (e.g., air) and liquids (e.g., water). Instead of attempting to monitor the corresponding amount of fluid discharged from the outlet end of the biopsy channel, the fluid detection sensor may be positioned and configured to detect fluid at the inlet of the endoscope's aspiration channel, which is fluidly connected to the biopsy channel inside the endoscope. If the biopsy channel is not properly connected to the reprocessing machine, the fluid introduced into the biopsy channel may not flow back to the inlet of the aspiration channel. However, if the biopsy channel is properly connected, the fluid introduced into the biopsy channel may flow back to the inlet of the aspiration channel and be detected by the fluid detection sensor. In this way, the reprocessing machine can assess whether the endoscope's biopsy channel is properly connected before proceeding with subsequent steps in the cleaning process.

[0011] In one example, a method for detecting the connectivity of an endoscope's biopsy channel during an endoscope cleaning procedure is described. The method includes connecting a fluid supply line of an endoscope reprocessing machine to the endoscope's biopsy channel and connecting a fluid detection sensor of the endoscope reprocessing machine to the endoscope's suction connector. The method also includes introducing fluid into the fluid supply line connected to the endoscope's biopsy channel, and (a) detecting the fluid introduced into the fluid supply line connected to the biopsy channel by the fluid detection sensor via discharge from the endoscope's suction connector, or (b) failing to detect the fluid introduced into the fluid supply line connected to the biopsy channel by the fluid detection sensor via discharge from the endoscope's suction connector.

[0012] In another example, an endoscope reprocessing machine is described, comprising: a processing chamber configured to receive an endoscope to be reprocessed; a fluid supply line configured to connect to a biopsy channel of the endoscope; and a fluid detection sensor configured to connect to a suction connector of the endoscope. The machine also includes a controller configured to control the introduction of fluid into the fluid supply line connected to the biopsy channel of the endoscope, and to determine whether the fluid supply line is properly connected to the biopsy channel of the endoscope based on the detection of fluid by the fluid detection sensor.

[0013] Details of one or more examples are set forth in the accompanying drawings and description below. Other features, objects, and advantages will become apparent from the specification, drawings, and claims. Attached Figure Description

[0014] Figure 1 This is a block diagram of an exemplary configuration of an AER that can detect the connectivity between the endoscopic biopsy channel and the machine.

[0015] Figure 2 This is a schematic cross-sectional view of an exemplary configuration of an endoscope.

[0016] Figure 3 It is shown Figure 1 A schematic diagram of an exemplary configuration of AER.

[0017] Figure 4 This is a flowchart illustrating an exemplary technique for detecting the connectivity of the biopsy channel of an endoscope during an endoscope reprocessing procedure. Detailed Implementation

[0018] This disclosure generally relates to endoscope reprocessing machines and related endoscope reprocessing techniques for processing endoscopes previously inserted into and used on a patient to make them suitable for reuse on subsequent patients. In some examples, the disclosed systems and techniques are implemented to evaluate the quality of the connection formed between the endoscope reprocessing machine and the biopsy channel of the endoscope being reprocessed within the machine. If the connection between the endoscope's biopsy channel and the reprocessing machine is not properly fluid-tight, fluid delivered by the machine through the connection's outlet may fail to pass through the biopsy channel and may leak at the connection. If this occurs, the biopsy channel may not be properly processed within the endoscope reprocessing machine.

[0019] In some implementations, the quality of the connection between the endoscope's biopsy channel and the endoscope reprocessing machine is evaluated by fluidly connecting the biopsy channel to the machine, delivering fluid into the biopsy channel, and monitoring the presence of the delivered fluid at the entrances of different channels of the endoscope. For example, test fluid may be introduced by the endoscope reprocessing machine at the entrance of the endoscope's biopsy channel, and a fluid detection sensor may be fluidly connected to the entrance of the endoscope's aspiration channel. If the fluid detection sensor detects fluid at the entrance of the aspiration channel in response to the introduction of fluid into the biopsy channel, the endoscope reprocessing machine can determine that the endoscope's biopsy channel is properly connected to the machine and proceed with the automated reprocessing steps. In contrast, if the endoscope reprocessing machine does not detect fluid at the entrance of the aspiration channel in response to the introduction of fluid into the biopsy channel (or, in other implementations, not detects fluid of appropriate volume and / or flow rate), the endoscope reprocessing machine can determine that the endoscope's biopsy channel is not properly connected to the machine. If this occurs, the endoscope reprocessing machine may issue one or more user alerts and / or prevent further processing of the endoscope (e.g., prevent the performance of cleaning and / or disinfection steps) until the connection error is corrected.

[0020] Automated endoscope reprocessing machines (AERs) implementing the concepts and techniques of this disclosure can have a variety of different features and configurations. Figure 1 This is a block diagram of an exemplary configuration of an AER (Automatic Endoscopic Respirator) according to this disclosure, which detects the connectivity of the endoscopic biopsy channel to the machine. Figure 1 In the example, AER 10 is shown as including an outer housing 12 arranged to house and protect the components of the AER. AER 10 includes one or more processing chambers 14 configured to receive a medical device 16, such as an endoscope 16, to be processed therein. AER 10 also includes one or more doors to provide access to each processing chamber 14 for loading the endoscope 16 into the chamber, sealing the chamber during processing, and removing the endoscope from the processing chamber after processing. In various specific implementations, AER 10 may be configured as a basin machine, wherein the endoscope 16 is loaded into and unloaded from the processing chamber 14 through a top or upper opening, or configured as a straight-through machine, wherein the endoscope 16 is loaded into the processing chamber 14 through a first door on one side of the machine (e.g., the dirty or non-sterile side) and unloaded from the processing chamber through a second door on the opposite side of the machine (e.g., the clean or sterile side).

[0021] In use, the operator places the endoscope 16 into the endoscope carrier, which is then positioned within the processing chamber 14. The endoscope carrier may be a basket with a wireframe or lattice structure that allows fluid to move in and out of the carrier once positioned within the processing chamber 14. In some examples, the operator may fluidly connect each channel of the endoscope 16 to a connector on the endoscope carrier. The connector carried by the endoscope carrier may then mechanically and / or fluidly connect to a corresponding connector within the processing chamber 14 to fluidly connect the individual channels to the AER 10. This simplifies the process of connecting the endoscope 16 to the AER 10 without inserting the endoscope into the processing chamber 14 and then connecting each individual channel of the endoscope to the machine within the processing chamber.

[0022] The AER 10 may include a circulation system that circulates one or more reprocessing fluids 18 (such as detergents, sterilizing agents, disinfectants, water, alcohol, air, and / or any other suitable fluid) through the endoscope 16, partially or completely immersing the endoscope in the fluid within the processing chamber 14, and / or spraying the fluid onto the outer surface of the endoscope. The circulation system may include a fluid source and a circulation pump, wherein the circulation pump is fluidly connected to the fluid source so that fluid can be drawn from the fluid source into the circulation system. In some embodiments, the circulation system may include a mixing chamber in which the fluid can be mixed with another fluid (such as water), for example, to form a mixed or diluted fluid for delivery to the processing chamber 14 and the endoscope 16 therein.

[0023] In any case, the processing chamber 14 may include one or more nozzles 20, which may be in fluid communication with the one or more fluids 18, for example via a circulation pump, such that fluid pressurized by the circulation pump can be sprayed from the circulation system through the nozzles onto the outer surface of the endoscope 16. In some examples, each processing chamber 14 includes a plurality of nozzles 20 positioned around its periphery and / or one or more nozzles that can spray upward from the bottom plate of the processing chamber.

[0024] For example, in some embodiments, the treatment chamber 14 includes one or more rotating arm members. The rotating arm members may be rotatably mounted via a central hub sleeve rotatably connected around a rotating arm hub. Each spray arm may define a spray arm cavity. The spray arm cavity may extend at least a portion of the length of the spray arm and serve to operatively connect the hub sleeve cavity defined within the central hub sleeve to a plurality of spray jets. The interconnected hub sleeve cavities, spray arm cavities, and outlet spray openings together provide conduits for discharging pressurized fluid.

[0025] To clean, disinfect, and / or sterilize the internal channels within endoscope 16, AER 10 may include one or more supply lines 22 in fluid communication (e.g., via a circulation system pump) with one or more fluids 18, which may be positioned in fluid communication with the internal channels and / or ports of the endoscope. In some examples, processing chamber 16 may include one or more complementary connectors comprising the ends of the supply lines. The respective channels and / or ports of endoscope 16 may be fluidly connected to a main connector, which in turn connects to the complementary connectors within AER 10. In some examples, AER 10 may also include one or more flexible catheters that may be connected and / or sealingly engaged with the ports and / or channels defined by endoscope 16, allowing pressurized fluid from AER 10 to flow through the flexible catheters into the respective channels of the endoscope. Various connector configurations are available for making mechanical and / or fluid connections between the AER 10 (e.g., a fluid conduit in fluid communication with the machine) and the various channels and / or ports of the endoscope 16, such as threaded connectors, bayonet connectors, cam and groove connectors, etc. In any case, each of one or more connections made by the operator between the AER 10 and the various channels and / or ports of the endoscope 16 is expected to be fluid-tight to prevent fluid intended to pass through the corresponding channel of the endoscope from being deflected at the connection location.

[0026] During operation, the operator may perform one or more manual reprocessing steps on the endoscope 16 prior to introducing the endoscope into the AER 10. Types of manual cleaning activities that may be performed on the endoscope include disassembly and removal of components, application of a brush to clean the channels, wiping to remove visible liquids and solids, and other human-performed cleaning actions. After completing any desired manual reprocessing steps, the operator may introduce the endoscope 16 into the processing chamber 14 of the AER 10 for automated reprocessing. In some examples, the operator may insert the endoscope 16 into an endoscope carrier and fluidly connect one or more (e.g., optionally all) of the endoscope's channels to a multi-port connector carried by the carrier. For example, the operator may fluidly connect the inlet of the biopsy channel and the inlet of the aspiration channel of the endoscope 16 to a multi-port connector carried by the carrier. The operator may then insert the carrier into the processing chamber 14, where the multi-port connector is mechanically and / or fluidly connected to a corresponding connector within the processing chamber 14. Additionally or alternatively, the operator may insert the endoscope 16 into the processing chamber 16 and connect one or more (e.g., optionally all) of the endoscope’s channels (including the inlet of the biopsy channel and the inlet of the aspiration channel) to the corresponding connection lines of the AER 10 to make the channels fluidly communicate with the machine.

[0027] The AER 10 may include a user interface 24, through which an operator can interact to input information for controlling the AER and / or output information to the operator. The user interface 24 may be implemented using a presence-sensitive display, such as a resistive touchscreen, surface acoustic wave touchscreen, capacitive touchscreen, projected capacitive touchscreen, pressure-sensitive screen, acoustic impulse recognition touchscreen, or another presence-sensitive display technology. The user interface 24 may serve as an output (e.g., display) device using any one or more display devices, such as a liquid crystal display (LCD), dot matrix display, light-emitting diode (LED) display, organic light-emitting diode (OLED) display, or a similar display capable of outputting visible information to a user. The user interface 24 may include physically pressable buttons that can receive tactile input from an operator using the AER 10.

[0028] The AER 10 may include one or more controllers 26 that manage the overall operation of the AER. Controllers 26 may be communicatively coupled to sensors, supply control devices (e.g., pumps, valves), and / or other controllable components of the AER 10 to manage the overall operation of the machine. Controllers 26 include a processor and memory. The memory may store software for running the controller and may also store data generated or received by the processor. The processor may run the software stored in the memory to manage the operation of the device.

[0029] Figure 2 This is a schematic cross-sectional view of an exemplary configuration of an endoscope 16 that can be reprocessed according to the exemplary apparatus and techniques of this disclosure. As depicted, the endoscope 16 includes multiple sections, generally divided into an insertion tube 50, a control section 52, a universal cable or umbilical cord 54, and a connector section 56 (sometimes referred to as a light-guiding section). The insertion tube 50 extends from a proximal end to a distal end 60 and is configured for insertion into a patient. For simplicity, the various imaging, lighting, and rigidity components used in the endoscope, as well as the associated wiring and controls, are not depicted. Instead, Figure 2 This simplified illustration is intended to provide an exemplary endoscope passage. It should be understood that the concepts discussed herein are applicable to other shape factors and designs of endoscopes.

[0030] exist Figure 2In the example, control section 52 houses multiple controls for actuating the positioning, shape, and behavior of endoscope 16. For example, if the insertion tube 50 is flexible, control section 52 allows the operator to flex the insertion tube 50 based on the patient's anatomy and the endoscopic procedure. Control section 52 may include a suction valve 62 that allows the operator to controllably apply suction at the distal end 60 via suction channel 64. Control section 52 may also include an air / water valve 65 that allows air and / or water to be dispensed from air channel 66 (supplied from air source 68) or water channel 70 (supplied from a water source connected to water source connector 72) to the distal end 60 of the insertion tube. The depicted design of endoscope 16 also includes a water jet connector 74 via water jet channel 76 to provide additional water dispensing separate from air channel 66.

[0031] A universal cable 54 (also referred to as an "umbilical cable") connects connector section 56 to control section 52 of the endoscope. Connector section 56 can provide a light source, distributing light to the end of insertion tube 50 using fiber optic cable or other light guides. Imaging elements (e.g., a camera) for capturing imaging data may be located at or within connector section 56, or adjacent to the distal end 60 of insertion tube.

[0032] Figure 2 The endoscope 16 is also illustrated as having a biopsy port 80 (e.g., a biopsy valve) through which objects and / or instruments can be inserted and guided down to and out of the distal end 60 of the insertion tube 50. The biopsy port 80 is connected to an aspiration channel 64. The portion of the aspiration channel 64 extending from the biopsy port 80 to the distal end 60 of the insertion tube 50 is also referred to as the biopsy channel 82.

[0033] Therefore, the biopsy channel 82 extends from the biopsy port 80 through the biopsy channel outlet at the distal end 60 of the insertion tube 50. The biopsy channel 82 branches at a branch point 84 between the biopsy port 80 and the remainder of the aspiration channel 64. The remainder of the aspiration channel 64 extends proximally from the biopsy channel 82 through the control section 52 and the universal cable 54, returning to the aspiration connector 86 located at the connector section 56. During use, a vacuum source can be applied to the aspiration connector 86 to aspirate fluid and / or material into the distal end 60 of the insertion tube 50 via applied suction and control of the aspiration valve 62.

[0034] During reprocessing of endoscope 16, the operator can connect biopsy port 80 to AER 10 ( Figure 1One or more fluids are delivered via a biopsy port through a biopsy channel 82, and these fluids flow out from the distal end 60 of the insertion tube 50. The connection between the AER 10 and the biopsy port 80 can be evaluated before, during, and / or after delivery of one or more cleaning and / or disinfecting fluids through a fluid line designed to connect to the biopsy port to determine if the biopsy port is properly connected to the AER. For example, the AER may be connected to the biopsy port 80 of the endoscope 16, and one or more test fluids are introduced into the endoscope through the biopsy port. These one or more test fluids (which may be the same as or different from the actual fluid delivered to the channel during cleaning and / or disinfection) may flow through the insertion tube 50 and exit from the distal end 60 of the insertion tube. Furthermore, due to the interconnection between the biopsy channel 82 and the aspiration channel 64, these one or more test fluids may also flow via the aspiration channel to the aspiration connector 86 (e.g., where the aspiration valve 62 is removed or kept open to prevent valve blockage of backflow from the biopsy port to the aspiration connector).

[0035] Figure 3 This is a schematic diagram illustrating an exemplary configuration of an AER 10, which can be used to detect the connectivity of the biopsy channel 82 of an endoscope 16 during an endoscope reprocessing procedure. As shown in the figure, the AER 10 includes a previously described processing chamber 14 that houses the endoscope 16 for reprocessing. The AER includes one or more testing and / or reprocessing fluids 18 that can be delivered to the internal channels of the endoscope 16 and / or the outer surface of the endoscope within the processing chamber 14. Specifically, in the illustrated example, the AER 10 includes water 18A, a first cleaning and / or disinfecting liquid 18B, a second cleaning and / or disinfecting liquid 18C, and air 18D. The fluids 18 can be positioned in selective fluid communication with one or more (e.g., optionally all) channels of the endoscope 16 connected within the processing chamber 14. One or more pumps 90A to 90D control the fluid delivery within the AER 10.

[0036] In the illustrated example, endoscope 16 is connected to AER 10 in processing chamber 14 via one or more connectors 92. As illustrated, connector 92 is illustrated as a manifold with multiple ports for fluid connection to different channels of the endoscope. Fluid 18 can be delivered via connector 92 to one or more connection channels of endoscope 16 (e.g., when AER 10 is in contact with...). Figure 1 (When operating under the control of the controller 26 discussed).

[0037] Figure 3The AER 10 in the diagram is also illustrated as having at least one fluid detection sensor 94. The fluid detection sensor 94 may be fluidly connected to at least the suction connector 86 of the endoscope 16 via one or more connectors, flexible and / or non-flexible fluid lines, and / or other components communicating between the suction connector and the fluid detection sensor. The fluid detection sensor 94 may be communicatively coupled to the controller 26. The fluid detection sensor 94 may be implemented using various different types of sensors, including flow sensors (e.g., flow switches), pressure sensors, capacitive sensors, and combinations thereof. The fluid detection sensor 94 may detect the presence of fluid at the suction connector 86 and / or the amount of fluid flowing out of the suction connector, and transmit information about the detected fluid (e.g., presence, amount) to the controller 26.

[0038] During operation, the operator may load endoscope 16 into processing chamber 14 and fluidly connect one or more channels of the endoscope to AER 10. For example, the operator may fluidly connect the biopsy port 80 of endoscope 16 to a fluid line of AER 10 configured to deliver cleaning and / or disinfecting fluid to biopsy channel 82. The operator may also fluidly connect the aspiration connector 86 of endoscope 16 to fluid detection sensor 94. The fluid connection between aspiration connector 86 and AER 10 may or may not be connected to one or more fluids 18 for delivering cleaning and / or disinfecting fluid via the aspiration connector. While the connection between AER 10 and biopsy port 80 should be fluid-tight, equipment or operator issues may cause the connection to be non-fluid-tight (e.g., causing some or all of the fluid intended to be delivered to biopsy port 80 via the connection to instead drain or leak at the connection and actually enter the biopsy port).

[0039] To assess the suitability of the connection between the biopsy port 80 and the AER 10, the AER can monitor signals from a fluid detection sensor 94 fluidly connected to the biopsy port via the aspiration channel 64. For example, before, during, and / or after initiating reprocessing of the endoscope 16, when one or more fluids 18 are delivered to the internal channels and / or external surfaces of the endoscope, the AER can deliver fluid to the biopsy port 80 and monitor the corresponding detection of fluid at the aspiration connector 86.

[0040] For example, operating under the control of controller 26, AER 10 can control one or more pumps 90, valves, and / or other fluid delivery features of the AER to introduce fluid into fluid lines and associated connection ports of a machine intended to be connected to biopsy port 80. Exemplary fluids that can be introduced into biopsy channel 82 include, but are not limited to, air and water.

[0041] To effectively test the connection between AER 10 and biopsy channel 82, fluid can be delivered at appropriate pressure and volume. In some examples, the fluid delivered to biopsy port 80 can be pressurized to at least 1.5 bar, such as at least 2.0 bar, at least 2.5 bar, at least 3.0 bar, at least 4 bar, or at least 5 bar. For example, the fluid can be pressurized to a pressure in the range of 2 bar to 5 bar. The rate at which the fluid is delivered can vary depending on whether the fluid is a liquid (e.g., water) or a gas (e.g., air). For larger channels, such as biopsy channels, liquid fluid can be delivered at a rate in the range of 0.1 L / min to 10 L / min, such as 0.2 L / min to 5 L / min. Gaseous fluid can be delivered at a rate in the range of 5 L / min to 25 L / min, such as 10 L / min to 20 L / min, or approximately 15 L / min.

[0042] In response to the introduction of fluid into the biopsy port 80, the one or more fluid detection sensors 94 may detect the presence and / or amount (e.g., flow rate, volume) of fluid in the aspiration port 86. The controller 26 may receive data from the sensors 94 indicating the detected fluid and / or the amount of fluid. In some examples, the controller 26 may analyze the data indicating the fluid measured by the fluid detection sensors 94 and compare that data with information stored in memory. For example, the controller 26 may analyze the flow rate and / or volume of fluid measured at the aspiration port 86 and compare the measured flow rate and / or volume with one or more corresponding values ​​associated with the appropriate connection between the biopsy port 80 and the AER 10. In other examples, the controller 26 may determine that the fluid detection sensors 94 detect fluid in response to the introduction of fluid through a line intended to be connected to the biopsy port 80 (in which case, the controller 26 determines that an appropriate connection has been established), or determine that the fluid detection sensors do not detect fluid in response to the introduction of fluid through a line intended to be connected to the biopsy port (in which case, the controller determines that an appropriate connection has not been established).

[0043] If controller 26 determines, based on a signal from fluid detection sensor 94, that the connection between biopsy port 80 and AER 10 is sufficiently fluid-tight (e.g., by detecting fluid in aspiration port 86 and / or detecting the volume / flow rate of fluid corresponding to the fluid-tight connection), controller 26 may control AER 10 to start or continue the reprocessing procedure. For example, controller 26 may control one or more pumps 90, valves, and / or other fluid delivery features of AER 10 to introduce fluid into the internal passage of endoscope 16 and / or the external surface of endoscope for cleaning and / or sterilizing the endoscope. If controller 26 determines, based on a signal from fluid detection sensor 94, that the connection between biopsy port 80 and AER 10 is insufficiently fluid-tight (e.g., due to failure to detect fluid in aspiration port 86 and / or detection of a fluid volume / flow rate less than the volume / flow rate corresponding to the fluid-tight connection), controller 26 may take different control actions. For example, controller 26 may stop or disable AER 10 from reprocessing endoscope 16. Additionally or alternatively, controller 26 may control the issuance (e.g., via user interface 24) of a user alarm indicating that a fluid seal connection between the AER and the biopsy channel has not been detected.

[0044] Figure 4 This is a flowchart illustrating an exemplary technique for detecting the connectivity of the biopsy channel of an endoscope during an endoscopic reprocessing procedure. Figure 4 At step 100, exemplary techniques involve connecting the fluid supply line 22 of the AER 10 to the biopsy channel 82 of the endoscope 16. For example, an operator may fluidly connect the fluid supply line 22 of the AER 10 to the biopsy port 80 of the endoscope 16. In some examples, the user inserts the endoscope 16 into the processing chamber 14 and then connects the biopsy channel to the AER. In some examples, the operator fluidly connects the biopsy port 80 of the endoscope 16 to a multi-port connector carried by an endoscope carrier on which the endoscope is placed. The endoscope carrier is then inserted into the processing chamber 14, and a connection is established between the multi-port connector carried by the endoscope carrier and the AER 10.

[0045] Figure 4Step 102 in the exemplary technique involves connecting the fluid detection sensor 94 of the AER 10 to the suction connector 86 of the endoscope 16. For example, an operator may fluidly connect a fluid line connected to the fluid detection sensor 94 to the suction connector 86 of the endoscope 16. In some examples, the user inserts the endoscope 16 into the processing chamber 14 and then connects the suction connector to the fluid detection sensor. In some examples, the operator fluidly connects the suction connector 86 of the endoscope 16 to a multi-port connector carried by an endoscope carrier on which the endoscope is placed. The endoscope carrier is then inserted into the processing chamber 14, and a connection is established between the multi-port connector carried by the endoscope carrier and the AER 10 (e.g., the fluid detection sensor 94 of the AER).

[0046] In the case where the biopsy channel 82 is fluidly connected to one or more fluids 18 and the aspiration connector 86 is fluidly connected to the fluid detection sensor 94 of the AER 10, Figure 4 Step 104 of the exemplary technique involves introducing fluid into a fluid supply line 22 connected to the biopsy channel 82 of the endoscope 16. The controller 26 of the AER 10 can control the one or more pumps 90, valves and / or other fluid delivery features of the AER to deliver pressurized fluid 18 to the fluid supply line 22, such as air and / or water (e.g., first tested with one fluid and then tested with a second fluid).

[0047] At step 106, the controller 26 of the AER 10 may determine whether the fluid supply line 22 is properly connected to the biopsy channel 82 of the endoscope 16 based on the detection of fluid at the suction connector 86 by the fluid detection sensor 94. For example, this technique may involve (a) the fluid detection sensor 94 detecting fluid introduced into the fluid supply line 22 connected to the biopsy channel 82 via fluid discharge from the suction connector 86, or (b) the fluid detection sensor 94 failing to detect fluid introduced into the fluid supply line 22 connected to the biopsy channel 82 via fluid discharge from the suction connector 86. In some examples, the fluid detection sensor 94 measures the volume and / or flow rate of the fluid discharged from the suction connector 86 and compares the measured volume and / or flow rate with threshold information stored in memory corresponding to an appropriate fluid-sealed connection.

[0048] In either case, if the AER 10 determines that the fluid connection between the machine and the biopsy channel 82 of the endoscope 16 is sufficiently fluidly sealed, the AER may begin or continue the cleaning, sterilization, and / or disinfection steps of the endoscope. If the AER 10 determines that the fluid connection between the machine and the biopsy channel 82 of the endoscope 16 is insufficiently fluidly sealed, the AER may stop or prevent the initiation of the cleaning, sterilization, and / or disinfection steps of the endoscope, and / or issue one or more user alarms to notify the operator of the connection problem.

[0049] The techniques described in this disclosure can be implemented, at least in part, in hardware, software, firmware, or any combination thereof. For example, aspects of the techniques can be implemented within one or more processors, including one or more microprocessors, digital signal processors (DSPs), application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), or any other equivalent integrated or discrete logic circuits, and any combination of such components. The term "processor" can generally refer to any of the aforementioned logic circuits, alone or in combination with other logic circuits or any other equivalent circuits. Control units, including hardware, can also implement one or more of the techniques disclosed herein.

[0050] Such hardware, software, and firmware can be implemented within the same device or in separate devices to support the various operations and functions described in this disclosure. Furthermore, any of the units, modules, or components can be implemented together or individually as discrete but interoperable logical devices. Describing different features as modules or units is intended to highlight different functional aspects and does not necessarily imply that such modules or units must be implemented through separate hardware or software components. Rather, the functions associated with one or more modules or units can be performed through separate hardware or software components, or they can be integrated within common or separate hardware or software components.

[0051] The techniques described in this disclosure can also be implemented or encoded in a computer-readable medium, such as a non-transitory computer-readable storage medium containing instructions. Instructions embedded or encoded in a computer-readable storage medium can cause a programmable processor or other processor to perform the methods, for example, when executing the instructions. Non-volatile computer-readable storage media can include volatile and / or non-volatile memory forms, including, for example, random access memory (RAM), read-only memory (ROM), programmable read-only memory (PROM), erasable programmable read-only memory (EPROM), electronically erasable programmable read-only memory (EEPROM), flash memory, hard disk, CD-ROM, floppy disk, cassette tape, magnetic media, optical media, or other computer-readable media.

[0052] Various embodiments have been described. These and other embodiments are within the scope of the appended claims.

Claims

1. A method for detecting the connectivity of the biopsy channel of an endoscope during an endoscope reprocessing procedure, the method comprising: Connect the fluid supply line of the endoscope reprocessing machine to the biopsy channel of the endoscope; Connect the fluid detection sensor of the endoscope reprocessing machine to the suction connector of the endoscope; Fluid is introduced into the fluid supply line connected to the biopsy channel of the endoscope; as well as The determination of whether the fluid supply line is properly connected to the biopsy channel of the endoscope is based on the detection of the fluid by the fluid detection sensor.

2. The method according to claim 1, wherein, Determining whether the fluid supply line is properly connected to the biopsy channel of the endoscope based on the detection of the fluid by the fluid detection sensor includes: (a) the fluid introduced into the fluid supply line connected to the biopsy channel is detected by the fluid detection sensor via discharge from the suction connector of the endoscope, or (b) the fluid introduced into the fluid supply line connected to the biopsy channel is not detected by the fluid detection sensor via discharge from the suction connector of the endoscope.

3. The method according to any one of claims 1 or 2, further comprising: In response to the fluid being detected by the fluid detection sensor, the endoscope reprocessing machine continues to perform the cleaning procedure on the endoscope.

4. The method according to any one of claims 1 to 3, further comprising: In response to determining that the fluid supply line is not properly connected to the biopsy channel, the endoscope reprocessing machine performs one or both of the following: issues a user alarm and prohibits the cleaning procedure on the endoscope.

5. The method according to any one of claims 1 to 4, wherein: The endoscope includes an insertion cannula extending from a proximal end to a distal end, a control section, a connector section, and an umbilical cord extending between the control section and the connector section, all configured to be inserted into the patient's body. The biopsy channel extends from the biopsy port at the control section through the biopsy channel outlet at the distal end of the insertion tube; and The suction connector is located in the connector section.

6. The method according to claim 5, wherein, Connecting the fluid supply line of the endoscope reprocessing machine to the biopsy channel of the endoscope includes connecting the fluid supply line to the biopsy port.

7. The method according to any one of claims 1 to 6, wherein, The suction connector for connecting the fluid detection sensor to the endoscope includes connecting a fluid receiving line of the endoscope reprocessing machine to the suction connector of the endoscope, the fluid receiving line being in fluid communication with the fluid detection sensor.

8. The method according to any one of claims 1 to 7, wherein, The fluid is water.

9. The method according to any one of claims 1 to 8, wherein, The fluid is air.

10. The method according to any one of claims 1 to 9, wherein, The fluid is pressurized to at least 2 bar and delivered at a rate of at least 5 L / min.

11. The method according to any one of claims 1 to 10, wherein, The fluid detection sensor is one of a fluid contact sensor, a flow sensor, and a pressure sensor.

12. The method according to any one of claims 1 to 11, wherein: The endoscope reprocessing machine includes a processing chamber configured to receive the endoscope and deliver cleaning chemicals to one or both of the endoscope's inner lumen and outer surface. Connecting the fluid supply line of the endoscope reprocessing machine to the biopsy channel of the endoscope includes connecting the fluid supply line to the endoscope located in the processing chamber; and Connecting the fluid detection sensor of the endoscope reprocessing machine to the suction connector of the endoscope includes connecting the fluid detection sensor to the endoscope located in the processing chamber.

13. An endoscope reprocessing machine, the endoscope reprocessing machine comprising: Processing chamber, the processing chamber being configured to receive an endoscope to be further processed; A fluid supply line configured to connect to the biopsy channel of the endoscope; A fluid detection sensor, configured to connect to the suction connector of the endoscope; and The controller is configured to: Controls the introduction of fluid into the fluid supply line connected to the biopsy channel of the endoscope; as well as The determination of whether the fluid supply line is properly connected to the biopsy channel of the endoscope is based on the detection of the fluid by the fluid detection sensor.

14. The machine according to claim 13, wherein, The controller is configured to determine whether the fluid supply line is properly connected to the biopsy channel of the endoscope based on the detection of the fluid by the fluid detection sensor, including by at least one of the following: (a) the fluid introduced into the fluid supply line connected to the biopsy channel is detected by the fluid detection sensor via discharge from the suction connector of the endoscope, or (b) the fluid introduced into the fluid supply line connected to the biopsy channel is not detected by the fluid detection sensor via discharge from the suction connector of the endoscope.

15. The machine according to claim 13 or 14, wherein, The controller is configured to control the endoscope reprocessing machine to continue the cleaning procedure for the endoscope in the processing chamber in response to the fluid being detected by the fluid detection sensor.

16. The machine according to any one of claims 13 to 15, wherein, The controller is configured to, in response to determining that the fluid supply line is not properly connected to the biopsy channel, control the endoscope reprocessing machine to perform one or both of the following: issue a user alarm and prohibit the cleaning procedure of the endoscope in the processing chamber.

17. The machine according to any one of claims 13 to 16, wherein, The fluid supply line is configured to connect to the biopsy channel of the endoscope via a biopsy port connected to the endoscope.

18. The machine according to any one of claims 13 to 17, wherein, The fluid is one or both of air and water.

19. The machine according to any one of claims 13 to 18, wherein, The fluid detection sensor is one of a fluid contact sensor, a flow sensor, and a pressure sensor.

20. The machine according to any one of claims 13 to 19, wherein, The controller is configured to control the introduction of the fluid into the fluid supply line, the fluid being pressurized to at least 2 bar and delivered at a rate of at least 10 L / min.

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