Fluid management through anomaly detection

Abstract

A system for detecting an abnormality in a medical device during a medical procedure within a patient may include inflow tubing defining an inflow lumen configured to provide fluid from a fluid source to a site of the medical procedure. An inflow sensor may be in communication with the inflow lumen for sensing an inflow parameter of the fluid in the inflow lumen. The outflow tubing may define an outflow lumen configured to extract debris from the site of the medical procedure. An outflow sensor may be in communication with the outflow lumen for sensing an outflow parameter of the debris in the outflow lumen. There is a memory including instructions, and processing circuitry that, when in operation, may be configured by the instructions to identify an abnormality in either the inflow tubing or the outflow tubing based on comparing the inflow signal or the outflow signal, respectively, to a predetermined threshold.

Description

[Technical Field]

[0001] Priority claims This patent application claims the benefit of priority to U.S. Patent Application No. 63 / 379,071 (Attorney Docket No. 5409.820PRV) to Jake Terravecchia et al., entitled "PUMP TUBESET DEVELOPMENT," filed October 11, 2022, which is incorporated herein by reference in its entirety.

[0002] The examples described herein relate generally to medical pump systems. More particularly, the examples described herein relate to general practitioner pump systems, including fluid management with anomaly detection. [Background technology]

[0003] Endoscopes are typically used to provide access to internal locations of a patient so that a physician is provided with visual access. Some endoscopes are used in minimally invasive surgery to remove unwanted tissue or foreign material from a patient's body. For example, an endoscopic tissue removal device is an instrument used by a clinician to remotely access necrotic, cancerous, damaged, infected, or other unwanted soft tissue, bone, or other anatomical structure in an anatomical location, excise the unwanted material from adjacent biological structures, and transport it away from the anatomical location.

[0004] Some endoscopes have aspiration channels (also known as suction channels) to carry away excised tissue, stones (e.g., stones or stone fragments in various stone-forming areas), and clots, among other undesirable materials. A flow of irrigant (e.g., saline) can be introduced into the anatomical site through the irrigation channel in the endoscope during a procedure. The irrigation fluid can facilitate the removal of tissue debris, stone fragments, and other undesirable materials through the suction channel. The irrigation fluid can also help maintain a clear view of the anatomical environment for the clinician performing the procedure. The irrigation flow can also have a cooling effect in endoscopic tissue removal devices to help dissipate heat generated during the ablation of tissue or stones (e.g., kidney stones).

[0005] Irrigation tubing can become kinked or leak during a medical procedure. Additionally, undesirable material generated during an endoscopic procedure can accumulate and clog the working channels (e.g., aspiration channels) of the endoscope. Monitoring the channels for clogging and clearing blocked channels in a timely and efficient manner can reduce procedure times and improve the efficiency, safety, and success of endoscopic procedures. Summary of the Invention [Means for solving the problem]

[0006] In an example, a system for detecting an abnormality in a medical device during a medical procedure on a patient may include inflow tubing defining an inflow lumen. The inflow lumen may be configured to provide fluid from a fluid source to a site of the medical procedure. An inflow sensor may be in communication with the inflow lumen for sensing an inflow parameter of the fluid in the inflow lumen. The inflow sensor may be configured to generate an inflow signal indicative of the inflow parameter of the fluid. The outflow tubing may define an outflow lumen. The outflow lumen may be configured to extract debris from the site of the medical procedure. An outflow sensor may be in communication with the outflow lumen for sensing an outflow parameter of debris in the outflow lumen. The outflow sensor may be configured to generate an outflow signal indicative of the outflow parameter of the debris. The system may comprise a memory including instructions and processing circuitry configured by the instructions, when in operation, to receive at least one of the inflow signal or the outflow signal and to identify an abnormality in either the inflow tubing or the outflow tubing based on comparing the inflow signal or the outflow signal, respectively, to a predetermined threshold.

[0007] In an example, a method for detecting an abnormality in a medical device during a medical procedure on a patient may include receiving an inflow signal from an inflow sensor indicative of one or more inflow parameters of fluid in an inflow lumen; receiving an outflow signal from the outflow sensor indicative of one or more outflow parameters of debris in an outflow lumen; identifying an abnormality in the inflow or outflow lumen by comparing the inflow or outflow signal to a predetermined inflow threshold and a predetermined outflow threshold, respectively; and generating an inflow error or an outflow error based on the abnormality in the inflow or outflow lumen.

[0008] Various examples are illustrated in the accompanying drawing figures. Such examples are illustrative and are not intended to be comprehensive or exclusive examples of the present subject matter. [Brief explanation of the drawings]

[0009] [Figure 1]1 illustrates an example endoscope including an example system for fluid management through anomaly detection. [Figure 2] FIG. 1 is a block diagram of an example system for fluid management with anomaly detection. [Figure 3] FIG. 1 is a schematic block diagram of an example of a portion of an example system for fluid management with anomaly detection. [Figure 4] FIG. 10 is a graph of an example baseline including a buffer region for a fluid management system with anomaly detection. [Figure 5] FIG. 10 is a graph of an example baseline including a buffer region for a fluid management system with anomaly detection. [Figure 6] FIG. 10 is a graph of an example baseline including a buffer region for a fluid management system with anomaly detection. [Figure 7] FIG. 10 is a graph of an example baseline including a buffer region for a fluid management system with anomaly detection. [Figure 8] FIG. 10 is a graph of an example baseline including a buffer region for a fluid management system with anomaly detection. [Figure 9] FIG. 10 is a graph of an example baseline including a buffer region for a fluid management system with anomaly detection. [Figure 10] FIG. 1 is a schematic diagram of an example method for a fluid management system with anomaly detection. [Figure 11] FIG. 1 is a schematic diagram of an example computer-based clinical decision support system (CDSS). [Figure 12] FIG. 1 is a block diagram illustrating an example machine upon which one or more examples may be implemented. DETAILED DESCRIPTION OF THE INVENTION

[0010] An endoscope may include a tubular portion (elongated member) that is insertable into a bodily organ or cavity (or lumen) to assist in diagnosis or treatment. One or more working channels (e.g., aspiration or irrigation channels) may be disposed inside the tubular portion and extend along the length of the tubular portion. To reduce the risk of unintended engagement with unintended tissue, the insertable tubular portion may have a smaller diameter than the remainder of the endoscope. As a result, the working channel may also have a small lumen diameter. Therefore, due to the small diameter of the working channel, tissue debris and foreign matter (e.g., stones and their fragments) may accumulate and clog the working channel.

[0011] A fluid management system may be connected to the endoscope for providing irrigation fluid (e.g., saline) and suction to the endoscope. The fluid management system may include inlet and outlet tubing fluidly connected to the irrigation and suction passages of the endoscope, respectively. Like the working passages, the inlet and outlet tubing can become clogged, kinked, or blocked.

[0012] In this document, "obstruction" refers to tissue debris, stones (e.g., kidney stones or stone fragments), and other materials that may accumulate and partially or completely block the lumen of a passageway; "clogging" refers to a condition of partial or complete blockage of the passageway lumen; "kinking" refers to tubing that bends, distorts, or deforms in a way that interferes with the flow of fluid or debris through the tubing; and "leak" refers to damage to the tubing that causes leakage of fluid (e.g., irrigation fluid or debris) within the tubing. Clogging can occur in any working passageway of an endoscope.

[0013] Clogging in the aspiration passageway or outflow tubing can significantly reduce the efficiency of removing tissue debris and stone fragments therethrough. Slow or inefficient removal of undesirable material from the anatomical site can hinder or prevent further treatment (e.g., debridement or stone ablation), contaminate the anatomical site, or place the patient at further risk. On the other hand, clogging in the irrigation passageway or inflow tubing can reduce the volume or flow rate of irrigation fluid flowing therethrough and delivered to the anatomical environment. Slow irrigation flow can be less efficient at flushing undesirable material from the anatomical site and can increase the likelihood of clogging in the aspiration passageway. Reduced irrigation volume and flow rate can also affect the cooling effect of surgical instruments and the anatomical environment, potentially increasing the chance of heat accumulation in the anatomical site. Furthermore, clogging in the working passageway can block the endoscope lens, impairing visibility of the object under examination and reducing the quality of images taken of the anatomical environment, thereby increasing the difficulty and duration of the procedure.

[0014] Various approaches have been attempted to prevent or resolve clogging of endoscope passageways. For example, breaking down undesirable material (e.g., tissue debris or stone fragments) into smaller elements can reduce the likelihood of clogging in the passageways. However, this can consume more energy, increase procedure times, and potentially increase patient risk due to the additional procedure complexity and time. Fine particles or stone dust can reduce visibility of the surgical field. Traditionally, clearing of the working passageway has typically been performed externally, requiring the clinician to retract the endoscope from the body, flush the blocked endoscope to clear it, and then reinsert it into the anatomical site. This approach increases procedure time, inconveniences the clinician, and can increase surgical risk for the patient. In-situ clearing of the working passageway typically requires high-pressure irrigation while the endoscope is inserted and held in place, which can impose excessive positive pressure on internal organs.

[0015] The inventors of the present disclosure have recognized an unmet need for an endoscopic system that can monitor irrigation and aspiration lines to determine abnormalities in such lines (e.g., kinks or leaks in the tubing, blockages, or clogs, etc.).

[0016] Disclosed herein are systems and methods of fluid management with anomaly detection for use with an endoscope. A fluid management system with anomaly detection for use with an endoscope or other medical system is described herein with reference to Figures 1-12.

[0017] 1 is a diagram illustrating an example endoscope system 100 including an example fluid management system 102 with anomaly detection and an endoscope 110. The fluid management system 102 may include an inlet tubing set (inlet tubing 104), an outlet tubing set (outlet tubing 106), a suction source 120, an irrigation source 130, and an suction / irrigation control unit 140.

[0018] The endoscope 110 can extend from a distal end to a sheath comprising a tube 111 extending to a hub 112. The hub 112 can terminate at a proximal end. The endoscopic system 100 can include a light port 114 and a visual port 115. The light port 114 can function to provide light into the endoscope and out of the tube 111 so that features of interest in the anatomical environment (e.g., excised tissue or stones and material) can be illuminated. The light port 114 can enhance visibility, for example, when the feature of interest is located in low light conditions. The visual port 115 can function to provide a viewing window that allows a user to observe the feature of interest. The visual port 115 can be an optical window at the proximal end that provides visual access to a viewing lens at the distal end. In another example, the visual port 115 can provide a connection point for a camera to capture images or videos of the feature of interest and the anatomical environment. The images or videos can be output and displayed on a monitor. In yet another example, viewing port 115 may include a camera. The camera may be integral with viewing port 115, and one or more lights may be positioned proximate to the camera, such as to provide light in front of the camera. In an example, the one or more lights may derive their energy from a light source in the handle of endoscope 110.

[0019] The endoscope 110 may include an irrigation / aspiration port 113 for receiving suction or irrigation fluid. The irrigation / aspiration port 113 may be located external to the hub 112 or elsewhere in the endoscope system 100, such as at the proximal end of the endoscope system 100. The irrigation / aspiration port 113 may be a single connection point or may be separate connection points (113A and 113B), including one for connecting to the inlet tubing 104 and the other for connecting to the outlet tubing 106 to the working channel of the tube 111. The irrigation / aspiration port 113 may open to a working channel within the tube 111. The working channel may be sized, shaped, and configured to carry irrigation fluid or for aspiration. The same working channel may be used for irrigation and aspiration (also referred to as a unified irrigation / aspiration channel). In other examples, the irrigation and aspiration channels may be located separately within the tube 111.

[0020] Aspiration / irrigation control unit 140 can provide suction and irrigation to endoscopic system 100 during an endoscopic procedure while keeping the pressure of the anatomical environment under control, such as by maintaining the pressure substantially at a user-specified pressure level (e.g., the user-specified pressure with a tolerance such as ±5-10%). Aspiration / irrigation control unit 140 can include a pressure monitor 150, a control module 160, an inflow pump 158, an outflow pump 159, and a power supply 180. Control module 160 can communicate with a user interface 141, such as located external to aspiration / irrigation control unit 140, to control control module 160.

[0021] The suction source 120 may be connected to the suction / irrigation control unit 140 via outlet tubing 106. The suction / irrigation control unit 140 may include a control valve 142 configured to control suction between the suction source 120 and the irrigation control unit 140 so that suction can be stopped during all or part of an irrigation fluid application cycle. The irrigation source 130 may be connected to the suction / irrigation control unit 140 via inlet tubing 104. The inlet pump 158 and the control module 160 may each be included in or controlled by the suction / irrigation control unit 140 to pressurize the irrigation fluid before it enters the endoscope system 100 via the inlet tubing 104 and to extract debris from the endoscope system 100 via the outlet tubing 106. The inlet tubing 104 and the outlet tubing 106 may be connected at a common fitting, which may be coupled to a common line for supplying fluid or suction to the endoscope 110 via a single irrigation / suction port 113.

[0022] Control module 160 is configured to control operation of endoscope 110 in response to user commands from user interface 141, detected parameters of either inflow tubing 104 or outflow tubing 106, detected characteristics of inflow pump 158 or outflow pump 159, or some other condition of any of the components of endoscopic system 100. Control module 160 can detect an abnormality in either the inflow tubing or the outflow tubing (e.g., a unified irrigation / aspiration path, a separate irrigation path, or a separate aspiration path) based on an inflow parameter (e.g., a voltage supplied to either inflow pump 158 or outflow pump 159, a pressure in inflow tubing 104, or a pressure of a fluid supplied to inflow tubing 104, etc.) or an outflow parameter (e.g., a voltage supplied to outflow pump 159, a pressure in outflow tubing 106, or a pressure of a fluid supplied to outflow tubing 106, etc.), respectively, and can alert a clinician (e.g., with an alarm, signal, or alert, etc.) or send one or more control signals to any of the components of endoscopic system 100 to correct the detected abnormality in endoscopic system 100. The control module 160 can automatically adjust one or more irrigation flow parameters or one or more aspiration flow parameters to maintain the pressure of the anatomical environment ("ambient pressure") under control, such as to maintain the ambient pressure substantially at a user-specified pressure level.

[0023] 2 is a block diagram of an example system 200 configured to manage fluid through an endoscopic system (e.g., endoscopic system 100 (FIG. 1)) and detect anomalies in the fluid management system (e.g., fluid management system 102 (FIG. 1)). System 200 may include inlet piping 202 and outlet piping 206.

[0024] The inflow tubing 202 can define an inflow lumen 204. The inflow lumen 204 can be configured to provide a fluid (e.g., an irrigation liquid) from a fluid source 210 to a site of a medical procedure (e.g., the distal end of the tube 111 (FIG. 1)) via an irrigation port 205 (e.g., irrigation port 113A (FIG. 1)). The system 200 can also include an inflow sensor 212. The inflow sensor 212 can be a flow meter, an optical sensor, a thermometer or thermocouple, a viscometer, or the like. The inflow sensor 212 can be in communication with the inflow lumen 204 (e.g., can have at least a portion extending within the inflow lumen 204, can be in fluid communication with the inflow lumen 204, etc.) to sense or detect an inflow parameter 214 of the fluid in the inflow lumen 204. The inflow sensor 212 can be configured to generate an inflow signal 216 that can be indicative of the inflow parameter 214 of the fluid in the inflow lumen 204.

[0025] An inflow pump 240 (e.g., inflow pump 158) can be in communication with the inflow tubing 202 to control the fluid flow rate of the fluid through the inflow tubing 202 or inflow lumen 204. The inflow pump 240 can be controlled by adjusting the inflow pump voltage 242. In examples, the inflow parameter 214 can be any of the inflow pump voltage 242, the fluid flow rate 254, other parameters of the fluid in the inflow tubing 202 (e.g., temperature, viscosity, or clarity), etc.

[0026] The outflow tubing 206 can define an outflow lumen 208. The outflow tubing 206 can be configured to extract debris (e.g., excess fluid, ablated portions of tissue, or fragments of stones or other organic matter) from the site of the medical procedure (e.g., the distal end of the tube 111 (FIG. 1)) via aspiration port 209 (e.g., aspiration port 113B (FIG. 1)) to a waste collection portion 211. The system 200 can also include a stone collection strainer 131 and an obstruction removal actuator 133 to collect stones and remove larger chunks of debris from within the outflow lumen 208. In an example, the obstruction removal actuator 133 can be configured to help clear clogs or blockages in the outflow lumen 208.

[0027] The outflow sensor 218 may be a flow meter, an optical sensor, a thermometer or thermocouple, a viscometer, etc. The outflow sensor 218 may be in communication with the outflow lumen 208 (e.g., may have at least a portion extending within the outflow lumen 208, may be in fluid communication with the outflow lumen 208, etc.) to sense or detect an outflow parameter 220 of the fluid in the outflow lumen 208. The outflow sensor 218 may be configured to generate an outflow signal 222 that may be indicative of the outflow parameter 220 of the fluid in the outflow lumen 208.

[0028] An outflow pump 250 can be in communication with the outflow tubing 206 for controlling a debris flow rate 256 of the debris through the outflow lumen 208. The outflow pump 250 can be controlled by adjusting an outflow pump voltage 252. In examples, the outflow parameters 220 can be any of the outflow pump voltage 252, the debris flow rate 256, other parameters of the debris in the outflow tubing 206 (e.g., temperature, viscosity, or clarity), etc.

[0029] System 200 may also include memory 230 and processing circuitry 234. Memory 230 may include instructions 232. When in operation, processing circuitry 234 is configured by instructions 232 to receive at least one of the signals (e.g., inflow signal 216 or outflow signal 222) and to identify an abnormality in either inflow tubing 202, outflow tubing 206, tube 111 (FIG. 1), or any other component of endoscope system 100 (FIG. 1) based on comparing inflow signal 216 or outflow signal 222, respectively, to a predetermined threshold.

[0030] In an example, processing circuitry 234 can generate a control signal 258. The control signal 258 can be sent to any component of system 200 to change an operating parameter of that component, such as to adjust any of inflow parameter 214, outflow parameter 220, fluid flow rate 254, or debris flow rate 256 based on an anomaly detected in either inflow lumen 204 or outflow lumen 208. For example, control signal 258 can be configured to change the voltage supplied to either inflow pump 240 or outflow pump 250 to change their rates of delivery of irrigation fluid and debris, respectively.

[0031] As detailed herein, processing circuitry 234 may be connected to a display unit 260 and a clinical decision support system (CDSS 280). Display unit 260 may be configured to alert a clinician to any abnormalities detected by system 200, and CDSS 280 may be configured to aid the clinician in treating and diagnosing a patient during a medical procedure.

[0032] FIG. 3 is a schematic block diagram of an example anomaly detection system 300 for system 200 (FIG. 2). Anomaly detection system 300 may include an inflow piping anomaly detection module 310 and an outflow piping anomaly detection module 312. While shown as two separate components, inflow piping anomaly detection module 310 and outflow piping anomaly detection module 312 may be a single controller / processor (e.g., control module 160 (FIG. 1) or processing circuitry 234 (FIG. 2)). As shown in FIG. 3, anomaly detection system 300 may include an inflow piping pressure 302, an inflow fluid flow rate 303, and an inflow pump voltage 304. Each of inflow piping pressure 302, inflow fluid flow rate 303, and inflow pump voltage 304 may be detected by inflow sensor 212 (FIG. 2) and sent to anomaly detection system 300 as inflow signal 216 (FIG. 2). Similarly, the anomaly detection system 300 may include an outflow line pressure 314, an outflow debris flow rate 315, and an outflow pump speed (outflow pump voltage 316), each of which may be detected by an outflow sensor 218 (FIG. 2) and sent to the anomaly detection system 300 as an outflow signal 222 (FIG. 2).

[0033] The inlet line anomaly detection module 310 can compare one or both of the inlet line pressure 302, the inlet fluid flow rate 303, and the inlet pump voltage 304 to a respective predetermined threshold 320. Each of the inlet line pressure 302, the inlet fluid flow rate 303, and the inlet pump voltage 304 can be indicative of fluid flowing through the inlet lumen 204 (FIG. 2). The outlet line anomaly detection module 312 can compare one or both of the outlet line pressure 314, the outlet debris flow rate 315, and the outlet pump voltage 316 to a respective predetermined threshold 320. Each of the outlet line pressure 314, the outlet debris flow rate 315, and the outlet pump voltage 316 can be indicative of debris flowing through the outflow lumen 208 (FIG. 2).

[0034] 3 , the inlet piping anomaly detection module 310 can output an inlet piping fault 322 based on detecting a possible anomaly when comparing the inlet piping pressure 302, the inlet fluid flow rate 303, or the inlet pump voltage 304 to their respective predetermined thresholds 320. Similarly, the outlet piping anomaly detection module 312 can output an outlet piping fault 324 based on detecting a possible anomaly when comparing the outlet piping pressure 314, the outlet debris flow rate 315, or the outlet pump voltage 316 to their respective predetermined thresholds 320.

[0035] In an example, inlet tubing error 322 may indicate a kink, leak, or other problem (e.g., an irrigation source has run out of liquid, etc.) in inlet tubing 202 ( FIG. 2 ) or inlet lumen 204 ( FIG. 2 ), and a clinician may be alerted to the error or one or more components of endoscopy system 100 may be adjusted to address inlet tubing error 322. Outlet tubing error 324 may indicate a kink, leak, clog, or obstruction in outflow tubing 206 ( FIG. 2 ) or outflow lumen 208 ( FIG. 2 ), and a clinician may be alerted to the error or one or more components of endoscopy system 100 may be adjusted to address inlet tubing error 324.

[0036] 4-7 are graphical representations of inflow and outflow pumps having discharge pressure as a function of pump speed or pump voltage. In the example of FIGS. 4 and 5, processing circuitry 234 (FIG. 2) is connected to inflow sensor 212 (FIG. 2) and outflow sensor 218 (FIG. 2). Inflow sensor 212 and outflow sensor 218 are each configured to a fluid flow rate in inflow lumen 204 (FIG. 2) and a debris flow rate in outflow lumen 208 (FIG. 2), respectively. In examples, FIGS. 4 and 6 can represent graphical representations of inflow tubing 202 (FIG. 2), and FIGS. 5 and 7 can represent graphical representations of outflow tubing 206 (FIG. 2).

[0037] 4, the inflow reference line 400 is a linear relationship with a positive slope such that as the pump motor speed or signal voltage (sent to the pump) increases, the fluid flow rate within the lumen also increases. The system may include buffer regions 402 on either side of the inflow reference line 400, such as above and below the reference line 400. The buffer region 402 may be defined by a maximum limit 404 and a minimum limit 406.

[0038] In an example, when the known inflow pump motor speed or fluid flow rate at the inflow pump signal voltage exceeds maximum limit 404 (e.g., when outside buffer region 402), inflow piping fault detection module 310 (FIG. 3) can generate inflow piping fault 322 (FIG. 3) indicating a leak in the piping (e.g., inflow piping 202 (FIG. 2)). When the known inflow pump motor speed or fluid flow rate at the inflow pump signal voltage is less than minimum limit 406, inflow piping fault detection module 310 can generate inflow piping fault 322 indicating a kink in the piping (e.g., inflow piping 202 (FIG. 2)).

[0039] 4 may also be valid for the outflow lumen 208 because as pump speed increases, the debris flow rate in the outflow lumen 208 may also increase. Thus, when the fluid flow rate at the known outflow pump motor speed or outflow pump signal voltage exceeds a maximum limit 404 (e.g., outside of a buffer region 402), the outflow piping anomaly detection module 312 (FIG. 3) or processing circuitry 234 (FIG. 2) may generate an outflow piping fault 324 (FIG. 3) indicating a leak in the piping (e.g., the outflow piping 206 (FIG. 2)). When the fluid flow rate at the known outflow pump motor speed or outflow pump signal voltage is less than a minimum limit 406, the outflow piping anomaly detection module 312 may generate an outflow piping fault 324 indicating a kink in the piping (e.g., the outflow piping 206 (FIG. 2)).

[0040] As shown in FIG. 5, the outlet reference line 500 is a linear relationship between the discharge pressure as a function of the pump speed or signal voltage sent to the pump. Here, for an inflow pump, the graph may have a relationship similar to FIG. 4, such that the slope of the reference line may include a positive slope. In the case of a positive slope for the inflow pump, if the signal is detected above the maximum line of the buffer zone, the inflow piping anomaly detection module 310 (FIG. 3) may generate an inflow piping fault 322 (FIG. 3) indicating a kink in the inflow piping 202 (FIG. 2). If the signal is detected below the minimum line of the buffer zone, the inflow piping anomaly detection module 310 may generate an inflow piping fault 322 indicating a leak in the inflow piping 202.

[0041] However, when the outlet piping anomaly detection module 312 is comparing the discharge pressure against the pump motor speed or pump voltage, the slope of the outlet reference line 500 may have a negative slope such that as the pump motor speed or signal voltage (sent to the pump) increases, the pump discharge pressure decreases, as shown in Figure 5. The system may include buffer regions 502 on either side of the outlet reference line 500, such as above and below the reference line 500. The buffer region 502 may be defined by a maximum limit 504 and a minimum limit 506.

[0042] In an example, when the known outflow pump motor speed or the discharge pressure at the outflow pump signal voltage exceeds maximum limit 504 (e.g., when outside buffer region 502), outflow piping fault detection module 312 (FIG. 3) or processing circuitry 234 (FIG. 2) can generate outflow piping fault 324 (FIG. 3) indicating a leak or spill in the piping (e.g., outflow piping 206 (FIG. 2)). When the known outflow pump motor speed or the discharge pressure at the outflow pump signal voltage is less than minimum limit 506, outflow piping fault detection module 312 can generate outflow piping fault 324 indicating a kinked tube or a clog or blockage in the outflow lumen (e.g., outflow lumen 208) of the piping (e.g., outflow piping 206 (FIG. 2)).

[0043] Calibration of the reference lines (e.g., inflow reference line 400 or outflow reference line 500) may be performed completely off-site (e.g., at a factory or some third party prior to delivery of endoscopic system 100 ( FIG. 1 ) or system 200 ( FIG. 2 )), partially off-site, or on-site (e.g., after delivery of endoscopic system 100 or system 200 to a clinician). In an example, first point 520 of outflow debris flow rate reference line 500 may include a preset value, and second point 522 of outflow debris flow rate reference line 500 may be set during system setup before or during a medical procedure.

[0044] As shown in FIGS. 6 and 7, as the speed of a pump (e.g., inflow pump 240 (FIG. 2) or outflow pump 250 (FIG. 2)) is increased or decreased, pump buffer regions 602A and 602B, respectively, may be applied to the baseline. Additionally, timing factors may be added to the buffer regions. In an example, if the pressure in the lumen exceeds the maximum limit 604A of buffer region 602A for a first time limit 608, or if the pressure in the lumen falls below the minimum limit 606A of buffer region 602A for a second time limit 610, inflow piping anomaly detection module 310 (FIG. 3) or processing circuitry 234 (FIG. 2) may generate inflow piping fault 322 (FIG. 3). Thus, different operating parameters of the pump (e.g., increasing the speed, decreasing the speed, or maintaining a different pump speed) may result in buffer regions 602A or 602B, adjusting first time limit 608 or second time limit 610, etc.

[0045] Thus, system 200, and more specifically processing circuitry 234 (FIG. 2), inflow piping anomaly detection module 310 (FIG. 3), or outflow piping anomaly detection module 312 (FIG. 3), can monitor one or more parameters of the inflow or outflow (e.g., inflow parameter 214 (FIG. 2) or outflow parameter 220 (FIG. 2), respectively) to detect anomalies in the inflow or outflow lumens of the system.

[0046] 8, the first flow parameter threshold 804 may be a predetermined flow parameter that is above or below the flow parameter reference line 802 at a third set buffer 822. The second flow parameter threshold 806 may be a predetermined flow parameter that is above or below the flow parameter reference line 802 at a fourth set buffer 824. In an example, the fourth set buffer 824 may have a linear relationship with the flow parameter reference line 802 such that as the flow parameter reference line 802 increases, the fourth set buffer 824 increases, thereby increasing the distance between the second flow parameter threshold 806 and the flow parameter reference line 802 as the flow parameter reference line 802 increases.

[0047] The flow parameter reference line 802 can be a linear relationship created by at least two reference points (e.g., a first reference point 802A and a second reference point 802B). In an example, either the first reference point 802A or the second reference point 802B can be recorded in advance (e.g., before delivery of the system) by the manufacturer or a third party so that no or little calibration is required. In another example, either the first reference point 802A or the second reference point 802B can be pre-recorded, and the other of the first reference point 802A or the second reference point 802B can be found during a calibration step before or at the start of a medical procedure. Once the first reference point 802A and the second reference point 802B are determined, the flow parameter reference line 802 can be extrapolated across a range of speeds for the pump, and a first flow parameter threshold 804 and a second flow parameter threshold 806 can be set, respectively. Additionally, the system may adjust the first flow parameter threshold 804 or the second flow parameter threshold 806 during the medical procedure based on some flow parameter of the irrigation liquid or debris (e.g., temperature, viscosity, flow rate, or volume) to reduce the likelihood of false alarms (incoming or outgoing piping) when the flow parameters deviate.

[0048] 9, signal 901 (e.g., inlet signal 216 (FIG. 2) or outlet signal 222 (FIG. 2)) can be tracked as a function of time. Signal 901 can be indicative of one or more flow parameters (e.g., inlet parameter 214 (FIG. 2) or outlet parameter 220 (FIG. 2)). When signal 901 exceeds either first threshold 904 or second threshold 906 for a set length of time (the difference between first time 980A and second time 980B), the system (e.g., processing circuitry 234, inlet piping fault detection module 310, or outlet piping fault detection module 312) can generate an inlet piping or outlet piping fault (e.g., inlet piping fault 322 (FIG. 3) or outlet piping fault 324 (FIG. 3)).

[0049] 10 is a schematic diagram of an example method 1000. Method 1000 may be a method for detecting an abnormality in a medical device during a medical procedure on a patient. The method may include any of operations 1010-1040.

[0050] At operation 1010, the method 1000 may include receiving an inflow signal from the inflow sensor indicative of one or more inflow parameters of the fluid in the inflow lumen. At operation 1020, the method 1000 may include receiving an outflow signal from the outflow sensor indicative of one or more outflow parameters of the debris in the outflow lumen.

[0051] At operation 1030, method 1000 may include identifying an abnormality in the inflow or outflow lumen by comparing the inflow or outflow signal to a predetermined inflow threshold and a predetermined outflow threshold, respectively. At step 1040, method 1000 may include generating an inflow error or an outflow error based on the abnormality in the inflow or outflow lumen, respectively.

[0052] FIG. 11 shows a schematic diagram of an exemplary computer-based clinical decision support system (CDSS) 1100 (e.g., CDSS 280 (FIG. 2)) that can be configured to control one or more aspects of a system (e.g., endoscopic system 100 (FIG. 1) or system 200 (FIG. 2)) based on input from any one of the system's components (e.g., signals from endoscope 110, suction / irrigation control unit 140, user interface 141, control module 160, pressure monitor 150, inflow pump 158, or outflow pump 159 (all FIG. 1), or any component of system 200), inflow sensor 212, outflow sensor 218, inflow pump 240, or outflow pump 250, etc.). In an example, the CDSS 1100 may include an input interface 1102 through which patient-specific medical information such as age, weight, and gender, or procedure-specific information such as the location within the patient of a planned medical procedure, a planned route for the procedure, or planned steps of the procedure, may be provided as input features to an artificial intelligence (AI) model 1104; a processing unit 1106 (e.g., irrigation control unit 140 (FIG. 1) or processing circuitry 234 (FIG. 2)), etc., that can perform inference operations in which inputs from any one of the components of the endoscope system or fluid management system, signals transmitted based on any of the pumps (e.g., inflow pump 240 or outflow pump 250 (both FIG. 2)), medical information, or procedure-specific information may be applied to the AI ​​model to generate a suggested medical procedure; and a user interface (UI) (e.g., display unit 260 (FIG. 2)) through which the suggested medical procedure is communicated to a user, such as a clinician.

[0053] In some embodiments, the input interface 1102 may be a direct data link or the like between the CDSS 1100 and one or more medical devices (e.g., endoscopic system 100 (FIG. 1), system 200 (FIG. 2)) that can generate at least some of the input features. For example, the input interface 1102 may transmit input, medical information, procedure-specific information, or the like, from any one of the components of the endoscopic system or fluid management system directly to the CDSS 1100 during a therapeutic and / or diagnostic medical procedure. Additionally or alternatively, the input interface 1102 may be a conventional user interface that facilitates interaction between a user and the CDSS 1100. For example, the input interface 1102 may facilitate a user interface through which a user can manually input medical information, procedure-specific information, or the like. Additionally or alternatively, the input interface 1102 may provide the CDSS 1100 with access to an electronic patient record from which one or more input features can be extracted. Such electronic patient records may be stored in the database 1101. In any of these cases, the input interface 1102 may be configured to collect one or more of the following input characteristics associated with a particular patient prior to when the CDSS 1100 is used to evaluate the safest and most efficient procedure to complete the planned medical procedure:

[0054] In an example, patient-specific medical information such as age, weight, sex, or procedure-specific information such as location of an abnormality may be provided to the CDSS 1100 via the input interface 1102 .

[0055] In examples, medical procedure information, such as a planned path for the procedure or planned steps of the procedure, may also be provided to the CDSS 1100 via the input interface 1102 .

[0056] In an example, any one of the components of the endoscopic system (e.g., endoscope 110, suction / irrigation control unit 140, user interface 141, control module 160, pressure monitor 150, inflow pump 158, or outflow pump 159 (all in FIG. 1), or any component of system 200) can provide input to CDSS 1100 via input interface 1102.

[0057] In an example, signals transmitted by a pump or sensor (e.g., inflow sensor 212, outflow sensor 218, inflow pump 240, outflow pump 250, or any other component of system 200, etc.) can provide input to CDSS 1100 via input interface 1102.

[0058] Based on one or more of the above input features, the processing unit 1106 performs inference operations using the AI ​​model 1104 to generate the safest and most efficient medical procedure for performing the medical mission. For example, the input interface 1102 can deliver medical information, medical procedure information, output from any one of the components of the endoscope system, or a signal transmitted based on engagement with either the first engagement member or the second engagement member to the input layer of the AI ​​model 1104, which then passes these input features through the AI ​​model 1104 to the output layer. The AI ​​model 1104 can provide a computer system with the ability to perform tasks by making inferences based on patterns discovered in analyzing data without being explicitly programmed. The AI ​​model 1104 explores learning and building algorithms (e.g., machine learning algorithms) that can learn from existing data and make predictions about new data. Such algorithms can operate by building an AI model from example training data to make data-driven predictions or decisions expressed as outputs or evaluations.

[0059] There are two common modes of machine learning (ML): supervised ML and unsupervised ML. Supervised ML uses prior knowledge (e.g., examples correlating inputs to outputs or outcomes) to learn relationships between inputs and outputs. The goal of supervised ML is to learn functions that most closely resemble the relationships between training inputs and outputs, given training data, so that the ML model can implement the same relationships given inputs to generate corresponding outputs. Unsupervised ML is the training of ML algorithms using unclassified or unlabeled information and allowing the algorithm to act on that information without guidance. Unsupervised ML is useful in exploratory analysis because it can automatically identify structure in data.

[0060] Common tasks for supervised ML are classification and regression problems. Classification problems, also called categorization problems, aim to classify an item into one of several categorical values ​​(e.g., is this object an apple or an orange?). Regression algorithms aim to quantify some item (e.g., by providing a score for the value of some input). Some examples of commonly used supervised ML algorithms are logistic regression (LR), naive Bayes, random forest (RF), neural networks (NN), deep neural networks (DNN), matrix decomposition, and support vector machines (SVM).

[0061] Some common tasks for unsupervised ML include clustering, representation learning, and density estimation. Some examples of commonly used unsupervised ML algorithms are k-means clustering, principal component analysis, and autoencoders.

[0062] Another type of ML is federated learning (also known as collaborative learning), which trains algorithms across multiple distributed devices that maintain local data without exchanging data. This approach contrasts not only with traditional centralized machine learning techniques, where all local datasets are uploaded to a single server, but also with more classical distributed approaches that often assume that local data samples are uniformly distributed. Federated learning allows multiple participants to build a common, robust machine learning model without sharing data, thereby addressing important issues such as data confidentiality, data security, data access rights, and access to heterogeneous data.

[0063] In some examples, the AI ​​model may be trained continuously or periodically prior to performance of inference operations by the processing unit 1106. Thus, during inference operations, patient-specific input features provided to the AI ​​model may be passed from an input layer, through one or more hidden layers, and ultimately to an output layer corresponding to a proposed medical procedure. For example, if the patient's age, size, or some other medical information of the patient, along with medical information such as the patient's location, indicates that obtaining a sample may be difficult, the processing unit 1106 may suggest a smaller format endoscope, a more difficult path that may maximize imaging and sampling effort, or the maximum energy to be used for any cutting, ablation, or removal procedure.

[0064] During and / or after the inference operation, the output interface 1108 can transmit the safest, most efficient medical procedure, which can be communicated to the user via the user interface (UI), and / or can cause any component of the endoscopic system to automatically perform desired actions. For example, if imaging quality is poor, the processing unit 1106 can send a signal to the viewing port 115 to change the brightness, color, saturation, or any other light parameter of the light being transmitted; can send a control signal to the irrigation control unit 140 (FIG. 1) to vary the fluid delivered to the pump; can send a signal to a pump (e.g., the inflow pump 240 (FIG. 2)) to change the rate or volume of fluid delivered to the imaging site; and can send a signal to a pump (e.g., the outflow pump 250 (FIG. 2)) to increase or decrease the amount of suction provided to the imaging site. These are example actions that can be taken by the CDSS 1100 to assist in the prescription and administration of a medical procedure. However, the inventors of the present application contemplate how the CDSS 1100 can assist in all aspects of a medical procedure, such as planning before surgery, performing during surgery, or analyzing the procedure after surgery.

[0065] FIG. 12 shows a block diagram of an example machine 1200 in which any one or more of the techniques (e.g., methodologies) discussed herein can be implemented. The example can include or operate by logic or some components or mechanisms in machine 1200, as described herein. Circuitry (e.g., processing circuitry) is a collection of circuitry embodied in the tangible entity of machine 1200, including hardware (e.g., simple circuits, gates, logic, etc.). The building blocks of circuitry may be flexible over time. Circuitry includes building blocks that, when operating, can perform specific operations, either alone or in combination. In an example, the circuitry hardware can be invariably designed (e.g., hard-wired) to perform specific operations. In an example, the circuitry hardware can include variably connected physical components (e.g., execution units, transistors, simple circuits, etc.) that include machine-readable media that are physically changed (e.g., magnetically, electrically movable locations of invariant mass particles, etc.) to encode instructions for specific operations. When connected to a physical component, the underlying electrical properties of the hardware component are changed, for example, from insulator to conductor or vice versa. When operating, the instructions can cause the embedded hardware (e.g., an execution unit or loading mechanism) to create, via variable connections, circuitry units configured in the hardware to perform a portion of a particular operation. Thus, in examples, a machine-readable medium element is part of the circuitry or communicatively coupled to other components of the circuitry when the device is operating. In examples, any one of the physical components can be used in more than one member of two or more circuitries. For example, under operation, an execution unit can be used in a first circuit of a first circuitry at one time and then used again by a second circuit in the first circuitry or a third circuit in the second circuitry at a different time. Examples of the addition of these components to machine 1200 are as follows:

[0066] In alternative examples, machine 1200 may operate as a standalone device or may be connected to other machines (e.g., a network). In a networked deployment, machine 1200 may operate in both capacities as a server machine, a client machine, or both in a server-client network environment. In an example, machine 1200 may act as a peer machine in a peer-to-peer (P2P) (or other distributed) network environment. Machine 1200 may be a personal computer (PC), a tablet PC, a set-top box (STB), a personal digital assistant (PDA), a mobile phone, a web appliance, a network router, switch, or bridge, or any machine capable of executing instructions (serially or otherwise) that specify actions to be taken by that machine. Furthermore, while only a single machine is shown, the term “machine” should be interpreted as any collection of machines that individually or together execute a set (or multiple sets) of instructions to perform any one or more of the methodologies described herein, such as cloud computing, software as a service (SaaS), other computer cluster configurations, etc.

[0067] The machine (e.g., computer system) 1200 may include hardware processing units 1202 (e.g., a central processing unit (CPU), a graphics processing unit (GPU), hardware processor cores, or any combination thereof), some or all of which may communicate with each other via an interlink (e.g., a bus) 1230; a main memory 1204; static memory (e.g., memory or storage for firmware, microcode, basic input / output (BIOS), unified extensible firmware interface (UEFI), etc.) 1206; and mass storage 1208 (e.g., a hard drive, tape drive, flash storage, or other block device). The machine 1200 may further include a display unit 1210, an alphanumeric input device 1212 (e.g., a keyboard), and a user interface (UI) navigation device 1214 (e.g., a mouse). In an example, the display unit 1210, the input device 1212, and the UI navigation device 1214 may be touchscreen displays. The machine 1200 may additionally include a storage device (e.g., a drive unit) 1208, a signal generation device 1218 (e.g., a speaker), a network interface device 1220, and one or more sensors 1216, such as a global positioning system (GPS) sensor, a compass, an accelerometer, or other sensor. The machine 1200 may include an output control device 1228, such as serial (e.g., Universal Serial Bus (USB)), parallel, or other wired or wireless (e.g., infrared (IR), near field communication (NFC), etc.) communication, for communication with or control of one or more peripheral devices (e.g., a printer, a card reader, etc.).

[0068] The processing unit 1202, main memory 1204, static memory 1206, or registers of mass storage device 1208 may be or comprise machine-readable medium 1222 on which is stored one or more sets of data structures or instructions 1224 (e.g., software) that embody or are utilized by any one or more of the techniques or functions described herein. The instructions 1224 may also reside, completely or at least partially, within any of the registers of the processing unit 1202, main memory 1204, static memory 1206, or mass storage device 1208 during execution by machine 1200. In an example, one or any combination of the hardware processing unit 1202, main memory 1204, static memory 1206, or mass storage device 1208 may constitute machine-readable medium 1222. Although the machine-readable medium 1222 is shown as a single medium, the term “machine-readable medium” may include a single medium or multiple media (e.g., a centralized or distributed database, and / or associated caches and servers) configured to store one or more instructions 1224.

[0069] The term "machine-readable medium" may include any medium capable of storing, encoding, or carrying instructions for execution by machine 1200 to perform one or more of the techniques of this disclosure, causing machine 1200 to perform one or more of the techniques of this disclosure, or any medium capable of storing, encoding, or carrying data structures used by such instructions or data structures associated with such instructions. Non-limiting examples of machine-readable media may include solid-state memory, optical media, magnetic media, and signals (e.g., radio frequency signals, other photon-based signals, audio signals, etc.). In an example, a non-transitory machine-readable medium comprises a machine-readable medium with a plurality of particles having a fixed (e.g., stationary) mass and is thus a composition of matter. Thus, a non-transitory machine-readable medium is a machine-readable medium that is not a transient, propagating signal. Specific examples of non-transitory machine-readable media may include non-volatile memory such as semiconductor memory devices (e.g., electrically programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM)) and flash memory devices, magnetic disks such as internal hard disks and removable disks, magneto-optical disks, CD-ROM disks and DVD-ROM disks.

[0070] In an example, the information stored or otherwise provided on the machine-readable medium 1222 may be representative of the instructions 1224, such as the instructions 1224 themselves or a format from which the instructions 1224 may be derived. The format from which the instructions 1224 may be derived may be source code, encoded instructions (e.g., in compressed or encrypted form), packaged instructions (e.g., divided into multiple packages), or the like. The information representative of the instructions 1224 on the machine-readable medium 1222 may be processed by processing circuitry into instructions to perform any of the operations discussed herein. For example, deriving the instructions 1224 from information (e.g., processing by processing circuitry) may include compiling (e.g., from source code, object code, etc.), interpreting, reading, structuring (e.g., dynamically or statically linking), encoding, decoding, encrypting, decrypting, packaging, unpackaging, or otherwise manipulating the information into instructions 1224.

[0071] In an example, deriving the instructions 1224 may include assembling, compiling, or interpreting the information (e.g., by processing circuitry) to produce the instructions 1224 from some intermediate or preprocessed format provided by the machine-readable medium 1222. When the information is provided in multiple parts, it may be mixed, unpacked, and altered to produce the instructions 1224. For example, the information may be multiple compressed source code packages (or object code or binary executable code, etc.) on one or several remote servers. The source code packages may be encrypted as they traverse a network, and may be decrypted, decompressed, assembled (e.g., linked), compiled, or interpreted (e.g., into a library, a standalone executable, etc.) as needed and executed by the local machine.

[0072] The instructions 1224 may be further transmitted or received over a communications network 1226 using a transmission medium via a network interface device 1220 utilizing any one of several transport protocols (e.g., Frame Relay, Internet Protocol (IP), Transmission Control Protocol (TCP), User Datagram Protocol (UDP), Hypertext Transfer Protocol (HTTP), etc.). Example communications networks may include a local area network (LAN), a wide area network (WAN), a packet data network (e.g., the Internet), a LoRa / LoRaWAN, or a satellite communications network, a mobile phone network (e.g., a cellular network such as one conforming to the 3G, 4G LTE / LTE-A, or 5G standards), a Power On Telephone Service (POTS) network, and a wireless data network (e.g., the Institute of Electrical and Electronics Engineers (IEEE) 502.11 family of standards known as Wi-Fi®), the IEEE 502.15.4 family of standards, a peer-to-peer (P2P) network, among others. In an example, network interface device 1220 may include one or more physical jacks (e.g., Ethernet, coaxial, or telephone jacks) or one or more antennas for connecting to communications network 1226. In an example, network interface device 1220 may include multiple antennas for wireless communication using at least one of single-input multiple-output (SIMO), multiple-input multiple-output (MIMO), or multiple-input single-output (MISO) technologies. The term “transmission medium” should be interpreted to include any intangible medium capable of storing, encoding, or carrying instructions for execution by machine 1200, including digital or analog communications signals or other intangible media to facilitate communication of such software. Transmission media are machine-readable media.

[0073] The following non-limiting examples detail particular aspects of the present subject matter to, among other things, solve the problems and provide the benefits discussed herein.

[0074] Example 1 is a system for detecting an abnormality in a medical device during a medical procedure on a patient, the system comprising: inflow tubing defining an inflow lumen configured to provide fluid from a fluid source to a site of the medical procedure; an inflow sensor in communication with the inflow lumen for sensing an inflow parameter of the fluid in the inflow lumen, the inflow sensor configured to generate an inflow signal indicative of the inflow parameter of the fluid; outflow tubing defining an outflow lumen configured to extract debris from the site of the medical procedure; an outflow sensor in communication with the outflow lumen for sensing an outflow parameter of debris in the outflow lumen, the outflow sensor configured to generate an outflow signal indicative of the outflow parameter of the debris; a memory including instructions; and processing circuitry configured by the instructions, when in operation, to receive at least one of the inflow signal or the outflow signal and to identify an abnormality in either the inflow tubing or the outflow tubing based on comparing the inflow signal or the outflow signal, respectively, to a predetermined threshold.

[0075] In Example 2, the subject matter of Example 1 optionally includes an inflow pump in communication with the inflow tubing to control a fluid flow rate of fluid through the inflow lumen, the inflow pump being controlled by adjusting the inflow pump voltage, and an outflow pump in communication with the outflow tubing to control a debris flow rate of debris through the outflow lumen, the outflow pump being controlled by adjusting the outflow pump voltage.

[0076] In Example 3, the subject matter of Example 2 optionally includes, wherein the inflow signal and outflow signal indicate an inflow fluid flow rate and an outflow debris flow rate, respectively.

[0077] In Example 4, the subject matter of Example 3 optionally includes, in response to detecting that the inlet fluid flow rate exceeds a first inlet fluid flow rate threshold, the processing circuitry is configured to generate a first cleaning fault indicative of a leak in the inlet piping.

[0078] In Example 5, the subject matter of Example 4 optionally includes, in response to detecting an inflow fluid flow rate below a second inflow fluid flow rate threshold, the processing circuitry is configured to generate a second cleaning fault indicative of a kink in the inflow tubing.

[0079] In Example 6, the subject matter of Example 5 optionally includes wherein the first incoming fluid flow rate threshold is a first predetermined flow rate above the incoming reference line at a first set buffer, the second incoming fluid flow rate threshold is a second predetermined flow rate at a second set buffer below the incoming reference line, and the incoming reference line is an expected fluid flow rate during normal operating conditions.

[0080] In Example 7, the subject matter of one or more of Examples 3-6 optionally includes, in response to detecting that the outflow debris flow rate exceeds a first outflow debris flow rate threshold, the processing circuitry is configured to generate a first suction error indicative of a leak in the outflow tubing.

[0081] In Example 8, the subject matter of Example 7 optionally includes, in response to detecting an exit debris flow rate below a second exit debris flow rate threshold, the processing circuitry is configured to generate a second suction error indicating an obstruction or kink in the inlet tubing.

[0082] In Example 9, the subject matter of Example 8 optionally includes the first exit debris flow rate threshold being a predetermined debris flow rate above the exit debris flow rate reference line at a third set buffer, the second exit debris flow rate threshold being a predetermined debris flow rate below the exit debris flow rate reference line at a fourth set buffer, and the fourth set buffer having a linear relationship with the exit debris flow rate reference line such that as the exit debris flow rate reference line increases, the distance between the second exit debris flow rate threshold and the exit debris flow rate reference line increases.

[0083] In Example 10, the subject matter of Example 9 optionally includes wherein a first point on the outflow debris flow rate reference line comprises a preset value and a second point on the outflow debris flow rate reference line is set during system setup before or during a medical procedure.

[0084] In Example 11, the subject matter of one or more of Examples 2-10 optionally includes, wherein the inflow signal and the outflow signal indicate an inflow pump discharge pressure and an outflow pump discharge pressure, respectively.

[0085] In Example 12, the subject matter of Example 11 optionally includes, in response to detecting that the inflow pump discharge pressure exceeds a first inflow pump discharge pressure threshold, the processing circuitry is configured to generate a first cleaning fault indicative of a kink in the inflow piping.

[0086] In Example 13, the subject matter of Example 12 optionally includes, in response to detecting the inflow pump discharge pressure below a second inflow pump discharge pressure threshold, the processing circuitry is configured to generate a second cleaning fault indicative of a leak in the inflow piping.

[0087] In Example 14, the subject matter of Example 13 optionally includes wherein the first inflow pump discharge pressure threshold is a first predetermined discharge pressure above the inflow reference line at a first set buffer, the second inflow pump discharge pressure threshold is a second predetermined discharge pressure at a second set buffer below the inflow reference line, and the inflow reference line is a predicted pump discharge pressure during normal operating conditions.

[0088] In Example 15, the subject matter of one or more of Examples 11-14 optionally includes, in response to detecting that the outflow pump discharge pressure exceeds a first outflow pump discharge pressure threshold, the processing circuitry is configured to generate a first aspiration error indicative of a leak in the outflow tubing.

[0089] In Example 16, the subject matter of Example 15 optionally includes, in response to detecting an outflow pump discharge pressure below a second outflow debris pump discharge pressure threshold, the processing circuitry is configured to generate a second aspiration error indicating a kink or blockage in the outflow tubing.

[0090] In Example 17, the subject matter of Example 16 optionally includes, wherein the first outflow debris pump discharge pressure threshold is a third set buffer below the outflow debris pump discharge pressure reference line, the second outflow debris pump discharge pressure threshold is a fourth buffer below the outflow debris pump discharge pressure reference line, and the fourth set buffer increases as the outflow debris pump discharge pressure reference line increases such that the distance between the second outflow debris pump discharge pressure threshold and the outflow debris pump discharge pressure reference line increases as the outflow debris pump discharge pressure reference line increases.

[0091] In Example 18, the subject matter of Example 17 optionally includes wherein a first point on the effluent debris pump discharge pressure reference line comprises a preset value and a second point on the effluent debris pump discharge pressure reference line is set during system setup before or during a medical procedure.

[0092] In Example 19, the subject matter of one or more of Examples 2-18 optionally includes, wherein the processing circuitry is configured to send a control signal based on an anomaly measured in either the inlet piping or the outlet piping.

[0093] In Example 20, the subject matter of Example 19 optionally includes the control signal varying a voltage supplied to the inflow pump to vary an inflow pumping speed of the inflow pump.

[0094] In Example 21, the subject matter of one or more of Examples 19-20 optionally includes wherein the control signal varies a voltage supplied to the outflow pump to vary an outflow pumping speed of the outflow pump.

[0095] In Example 22, the subject matter of one or more of Examples 19-21 optionally includes the outlet piping comprising a debris trap configured to collect debris in the outlet piping, and the control signal opening the debris trap to clear the debris from the debris trap.

[0096] Example 23 is a method for detecting an abnormality in a medical device during a medical procedure on a patient, the method including receiving an inflow signal from an inflow sensor indicative of one or more inflow parameters of fluid in the inflow lumen; receiving an outflow signal from the outflow sensor indicative of one or more outflow parameters of debris in the outflow lumen; identifying an abnormality in the inflow lumen or the outflow lumen based on comparing the inflow signal or the outflow signal to a predetermined inflow threshold and a predetermined outflow threshold, respectively; and generating an inflow error or an outflow error based on the abnormality in the inflow lumen or the outflow lumen.

[0097] In Example 24, the subject matter of Example 23 optionally includes communicating the inflow or outflow error to a clinician performing the medical procedure via a display unit.

[0098] In Example 25, the subject matter of one or more of Examples 23-24 optionally includes generating a control signal to alter one or more components of the medical device to mitigate a kink, obstruction, or blockage causing an inflow or outflow error.

[0099] Example 26 is any element of any of Examples 1 to 25.

[0100] The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific examples that may be practiced. These embodiments are also referred to herein as "examples." Such examples may include elements in addition to those shown or described. However, the inventors also contemplate examples in which only those elements shown or described are provided. Furthermore, the inventors also contemplate examples that use any combination or permutation of those elements (or one or more aspects thereof) shown or described, either with respect to the specific example (or one or more aspects thereof) or with respect to any other example (or one or more aspects thereof) shown or described herein.

[0101] All publications, patents, and patent documents referenced herein are incorporated by reference in their entirety herein, as if individually incorporated by reference. In the event of a conflicting usage between this document and those documents so incorporated by reference, the usage in the incorporated references shall be considered supplementary to the usage in this document, and in the event of any irreconcilable conflict, the usage in this document shall control.

[0102] The terms "a" and "an" are used herein to include one or more, as is common in patent documents, regardless of any other instance or use of "at least one" or "one or more." Unless otherwise indicated, the term "or" is used herein to refer non-exclusively, or "A or B" is used to include "A but not B," "B but not A," and "A and B." In the appended claims, the terms "including" and "in which" are used as the plain-English equivalents of the respective terms "comprising" and "wherein." Also, in the appended claims, the terms "including" and "comprising" are intended to be open-ended, meaning that systems, devices, articles, or processes that include elements in addition to the elements listed after such terms in a claim are still deemed to be within the scope of that claim. Moreover, in the following claims, the terms "first," "second," and "third" are used merely as labels and are not intended to impose numerical requirements on their objects.

[0103] As used herein, the term "about" means approximately, in a range, roughly, or approximately. When used in conjunction with a numerical range, the term "about" modifies that range by extending the boundaries above and below the stated numerical value. In general, the term "about" is used herein to adjust a numerical value above and below the stated value by a variance of 10%. In one embodiment, the term "about" means plus or minus 10% of the numerical value of the number with which it is used. Thus, about 50% means a range of 45% to 55%. Numerical ranges proposed herein by endpoints include all numbers and fractions included within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.90, 4, 4.24, and 5). Similarly, numerical ranges recited herein by endpoints include all sub-ranges subsumed within that range (e.g., 1 to 5 includes 1 to 1.5, 1.5 to 2, 2 to 2.75, 2.75 to 3, 3 to 3.90, 3.90 to 4, 4 to 4.24, 4.24 to 5, 2 to 5, 3 to 5, 1 to 4, and 2 to 4). It is also understood that all numbers and fractions thereof are presumed to be modified by the term "about."

[0104] The foregoing description is intended to be illustrative, not limiting. For example, the above examples (or one or more aspects thereof) can be used in combination with each other. Other examples may be used by those skilled in the art upon reviewing the foregoing description. The Abstract is submitted with the understanding that it will allow the reader to quickly ascertain the nature of the technical disclosure, and will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be construed as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Accordingly, the following claims are hereby incorporated into the More Detailed Description, with each claim standing on its own as a separate embodiment. The scope of the examples should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

[0105] The devices disclosed herein may be designed to be disposed of after a single use, or they may be designed to be used multiple times. However, in either case, the device may be reconditioned for reuse after at least one use. Reconditioning may involve a combination of disassembly of the device followed by cleaning or replacement of particular elements and subsequent reassembly. Specifically, the device may be disassembled, and any number of particular elements or parts of the device may be selectively replaced or removed in any combination. Upon cleaning and / or replacement of particular parts, the device may be reassembled for subsequent use either at a reconditioning facility or by a surgical team immediately prior to a surgical procedure. Those skilled in the art will appreciate that reconditioning of a device may utilize a variety of different techniques for disassembly, cleaning / replacement, and reassembly. Use of such techniques, and the resulting use of the reconditioned device, are all within the scope of the present application.

[0106] Preferably, the invention described herein is processed prior to surgery. First, new or used instruments are obtained and, if necessary, cleaned. Next, the instruments can be sterilized. In one sterilization technique, the instruments are placed in a closed, sealed container, such as a plastic or TYVEK® bag. The container and instruments are then placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or higher-energy electrons. The radiation kills bacteria on the instruments and container. The sterilized instruments can then be stored in a sterile container. The sealed container keeps the instruments sterile until opened in the medical facility. Devices can also be sterilized using any other technique known in the art, including beta or gamma radiation, ethylene oxide, or steam. [Explanation of symbols]

[0107] 100 Endoscopy System 102 Fluid Management Systems 104 Inlet piping 106 Outlet piping 110 Endoscope 111 tube 112 Hub 113, 113A, 113B Irrigation / Aspiration Ports 114 optical ports 115 Visual Port 120 Suction source 130 Cleaning Source 131 Stone collection strainer 133 Obstacle Removal Actuator 140 Suction / Irrigation Control Unit 141 User Interface 142 Control valve 150 Pressure Monitor 158 Inflow Pump 159 Outflow Pump 160 Control Module 180 Power supply 200 systems 202 Inlet piping 204 Inflow lumen 205 Washing port 206 Outlet piping 208 Outflow lumen 209 Suction port 210 Fluid supply source 211 Waste Collection Department 212 Inflow sensor 214 Inflow parameters 216 Inflow signal 218 Outflow Sensor 220 Runoff Parameters 222 Outflow Signal 230 memory 232 Command 234 Processing Circuit Mechanism 240 Inflow Pump 242 Inlet Pump Voltage 250 Outflow Pump 252 Outflow Pump Voltage 256 Debris flow rate 258 Control Signals 260 display unit 280 Clinical Decision Support System, CDSS 300 Anomaly Detection System 302 Inlet pipe pressure 303 Inflow fluid flow rate 304 Inlet Pump Voltage 310 Inflow piping abnormality detection module 312 Outlet Pipe Abnormality Detection Module 314 Outlet Pipe Pressure 315 Outflow debris flow rate 316 Outflow Pump Voltage 320 Predetermined Threshold 322 Inlet piping error 324 Outlet piping error 400 Inflow standard line 402 Buffer area 404 maximum limit 406 Minimum limit 500 Outflow debris velocity reference line 502 buffer area 504 maximum limit 506 Minimum limit 520 First Point 522 Second Point 602A, 602B buffer area 604A maximum limit 606A Minimum 608 First Time Limit 610 Second Time Limit 802 Flow Parameter Reference Line 802A First Reference Point 802B Second Reference Point 804 First Flow Parameter Threshold 806 Second flow parameter threshold 822 Third Setting Buffer 824 The Fourth Buffer 901 signal 904 First Threshold 906 Second Threshold 980A First Time 980B Second Time 1100 Clinical Decision Support System, CDSS 1101 Database 1102 Input Interface 1104 Artificial Intelligence (AI) Model 1106 Processing equipment 1108 Output Interface 1200 machines 1202 Hardware Processing Unit 1204 Main Memory 1206 Static Memory 1208 Mass storage devices, storage devices 1210 Display Unit 1212 Alphanumeric Input Device 1214 User Interface (UI) Navigation Devices 1216 Sensor 1218 Signal Generating Device 1220 Network Interface Device 1222 Machine-Readable Medium 1224 Data Structures, Instructions 1226 Communication Network 1228 Output Control Device 1230 Interlink

Claims

1. 1. A system for detecting an abnormality in a medical device during a medical procedure in a patient, comprising: inlet tubing defining an inlet lumen configured to provide fluid from a fluid source to the medical procedure site; an inflow sensor in communication with the inflow lumen for sensing an inflow parameter of the fluid in the inflow lumen, the inflow sensor configured to generate an inflow signal indicative of the inflow parameter of the fluid; an outflow tubing defining an outflow lumen configured to extract debris from the site of the medical procedure; an outflow sensor in communication with the outflow lumen for sensing an outflow parameter of the debris in the outflow lumen, the outflow sensor configured to generate an outflow signal indicative of the outflow parameter of the debris; a memory containing instructions; processing circuitry, when in operation, receiving at least one of the incoming signal or the outgoing signal; and identifying an anomaly in either the inlet pipe or the outlet pipe based on comparing the inlet signal or the outlet signal, respectively, with a predetermined threshold; processing circuitry configured by said instructions; A system comprising:

2. an inflow pump in communication with the inflow tubing for controlling a fluid flow rate of the fluid through the inflow lumen; an outflow pump in communication with the outflow tubing for controlling a debris flow rate of the debris through the outflow lumen; The system of claim 1 , comprising:

3. The system of claim 2 , wherein the inflow signal and the outflow signal are indicative of an inflow fluid flow rate and an outflow debris flow rate, respectively.

4. In response to detecting that the incoming fluid flow rate exceeds a first incoming fluid flow rate threshold, the processing circuitry: generating a first cleaning fault indicative of a leak in the inlet line; The system of claim 3 , configured to:

5. In response to detecting the incoming fluid flow rate below a second incoming fluid flow rate threshold, the processing circuitry: generating a second cleaning fault indicative of a kink in the inlet piping; The system of claim 4 configured to:

6. 6. The system of claim 5, wherein the first incoming fluid flow rate threshold is a first predetermined flow rate above an incoming reference line at a first set buffer, and the second incoming fluid flow rate threshold is a second predetermined flow rate at a second set buffer below the incoming reference line, the incoming reference line being an expected fluid flow rate during normal operating conditions.

7. In response to detecting that the exiting debris flow rate exceeds a first exiting debris flow rate threshold, the processing circuitry: generating a first aspiration error indicative of a leak in the outlet tubing; The system of claim 3 , configured to:

8. In response to detecting the exiting debris flow rate below a second exiting debris flow rate threshold, the processing circuitry: generating a second aspiration error indicating an obstruction or kink in the inlet piping; The system of claim 7 configured to:

9. 9. The system of claim 8, wherein the first exiting debris flow rate threshold is a predetermined debris flow rate above an exiting debris flow rate reference line at a third set buffer, the second exiting debris flow rate threshold is a predetermined debris flow rate below the exiting debris flow rate reference line at a fourth set buffer, and the fourth set buffer has a linear relationship with the exiting debris flow rate reference line such that as the exiting debris flow rate reference line increases, the distance between the second exiting debris flow rate threshold and the exiting debris flow rate reference line increases.

10. 10. The system of claim 9, wherein a first point on the exit debris flow rate reference line comprises a preset value and a second point on the exit debris flow rate reference line is set during setup of the system before or during the medical procedure.

11. The system of claim 2 , wherein the inlet and outlet signals are indicative of an inlet pump discharge pressure and an outlet pump discharge pressure, respectively.

12. In response to detecting that the inflow pump discharge pressure exceeds a first inflow pump discharge pressure threshold, the processing circuitry: generating a first cleaning fault indicative of a kink in the inlet piping; The system of claim 11 configured to:

13. In response to detecting the inflow pump discharge pressure below a second inflow pump discharge pressure threshold, the processing circuitry: generating a second cleaning fault indicative of a leak in the inlet line; The system of claim 12 configured to:

14. 14. The system of claim 13, wherein the first inlet pump discharge pressure threshold is a first predetermined discharge pressure above an inlet reference line at a first set buffer, and the second inlet pump discharge pressure threshold is a second predetermined discharge pressure at a second set buffer below the inlet reference line, and the inlet reference line is a predicted pump discharge pressure during normal operating conditions.

15. In response to detecting that the outlet pump discharge pressure exceeds a first outlet pump discharge pressure threshold, the processing circuitry: generating a first aspiration error indicative of a leak in the outlet tubing; The system of claim 11 configured to:

16. In response to detecting the outflow pump discharge pressure below a second outflow debris pump discharge pressure threshold, the processing circuitry: generating a second aspiration error indicating a kink or blockage in the outlet tubing; The system of claim 15 configured to:

17. 17. The system of claim 16, wherein the first outflow debris pump discharge pressure threshold is a third set buffer below an outflow debris pump discharge pressure reference line, the second outflow debris pump discharge pressure threshold is a fourth set buffer below the outflow debris pump discharge pressure reference line, and the fourth set buffer increases as the outflow debris pump discharge pressure reference line increases such that the distance between the second outflow debris pump discharge pressure threshold and the outflow debris pump discharge pressure reference line increases as the outflow debris pump discharge pressure reference line increases.

18. 18. The system of claim 17, wherein a first point on the effluent debris pump discharge pressure reference line comprises a preset value and a second point on the effluent debris pump discharge pressure reference line is set during setup of the system before or during the medical procedure.

19. the processing circuitry transmitting a control signal based on the anomaly measured in either the inlet pipe or the outlet pipe; The system of claim 2 , configured to:

20. 20. The system of claim 19, wherein the control signal varies a voltage supplied to the inflow pump to vary an inflow pumping speed of the inflow pump.

21. 20. The system of claim 19, wherein the control signal varies a voltage supplied to the outflow pump to vary an outflow pumping speed of the outflow pump.

22. The outflow pipe is a debris trap configured to collect debris in the outlet line; Equipped with 20. The system of claim 19, wherein the control signal opens the debris trap to clear the debris from the debris trap.

23. 1. A method for detecting an abnormality in a medical device during a medical procedure in a patient, comprising: receiving an inflow signal from the inflow sensor indicative of one or more inflow parameters of a fluid in the inflow lumen; receiving an outflow signal from an outflow sensor indicative of one or more outflow parameters of debris in the outflow lumen; identifying an abnormality in the inflow or outflow lumen by comparing the inflow or outflow signal to a predetermined inflow threshold and a predetermined outflow threshold, respectively; generating an inflow error or an outflow error based on the abnormality in the inflow lumen or the outflow lumen, respectively; A method comprising:

24. communicating said inflow error or said outflow error to a clinician performing said medical procedure via a display unit; 24. The method of claim 23, comprising:

25. generating a control signal to modify one or more components of the medical device to mitigate the anomaly causing the inflow error or the outflow error; 24. The method of claim 23, comprising:

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