Automated flow control for fluid management

By incorporating a bypass flow control valve with a feedback control algorithm in urological fluid management systems, the challenges of regulating inter-renal pressure and maintaining fluid outflow are addressed, resulting in improved pressure control and procedural safety.

WO2025101650A1PCT designated stage expired Publication Date: 2025-05-15GYRUS ACMI INC

Patent Information

Application Number
PCT/US2024/054781
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-11-06
Filing Date
2024-11-06
Publication Date
2025-05-15

AI Technical Summary

Technical Problem

Current urological fluid management systems face challenges in effectively regulating inter-renal pressure and maintaining desired fluid outflow, particularly due to limitations in pressure control methods such as isostatic pressure control and peristaltic pump driven irrigation and suction.

Method used

The introduction of a bypass flow control valve between the inflow and outflow pathways in a urological fluid management system, which is controlled by a feedback control algorithm, allows for automatic adjustment of flow rates to mitigate high pressures and provide pressure relief.

Benefits of technology

This solution enables efficient regulation of inter-renal pressure, reduces the risk of high-pressure situations, and provides a secondary flow control mechanism to manage inflow pressure without reversing the flow of the inflow device, thus enhancing the safety and effectiveness of urological procedures.

✦ Generated by Eureka AI based on patent content.

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Abstract

Various embodiments disclosed relate to urological fluid management systems and methods. A system may receive a measured inflow pressure of fluid flow through the inflow pathway. A system may determine a calculated inflow pressure based on a target inflow rate of fluid through the inflow pathway. A system may compare the calculated inflow pressure with the measured inflow pressure. If the measured inflow pressure exceeds the calculated inflow pressure, the system may automatically adjust a bypass flow control valve. The bypass control valve may be between the inflow pathway and the outflow pathway. The bypass control valve may be between the inflow pathway and a waste pathway.
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Description

AUTOMATED FLOW CONTROL FOR FLUID MANAGEMENTPRIORITY CLAIM

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application Serial No. 63 / 596,510, filed November 6, 2023 and U.S. Provisional Patent Application Serial No. 63 / 596,520, filed November 6, 2023, the contents of which are incorporated herein by reference.BACKGROUND

[0002] A variety of medical devices are used in urological procedures, such as in treatment of calculi in the urological system. Such devices can include scopes or other devices. Often, such devices are used in conjunction with a fluid management system, such as to provide irrigation fluid and suction through the device to the treatment site. Fluid flow can help regulate the treatment area and flush away debris.SUMMARY OF THE DISCLOSURE

[0003] In some aspects, the techniques described herein relate to a method of using a urological fluid management system having an inflow pathway and an outflow pathway, wherein the system is configured for regulating inter-renal pressure and maintaining a desired fluid outflow, the method including: receiving a measured inflow pressure of fluid flow through the inflow pathway; determining a calculated inflow pressure based on a target inflow rate of fluid through the inflow pathway; comparing the calculated inflow pressure with the measured inflow pressure; and if the measured inflow pressure exceeds the calculated inflow pressure, automatically adjusting a bypass flow control valve between the inflow pathway and the outflow pathway.

[0004] In some aspects, the techniques described herein relate to a urological fluid management system including: an inflow device actuatable for pumping a fluid through an inflow pathway with inflow pressure sensor; an outflow device actuatable for pumping a fluid through on outflow pathway with an outflow pressure sensor; and an automatic bypass flow valve fluidly connected between the inflow pathway and the outflow pathway, the bypass flow valve actuatable for altering pressure in the system.

[0005] In some aspects, the techniques described herein relate to a method of using a urological fluid management system having an inflow pathway, an outflow pathway, and awaste outlet, wherein the system is configured for regulating inter-renal pressure and maintaining a desired fluid outflow, the method including: receiving a measured inflow pressure of fluid flow through the inflow pathway; determining a calculated inflow pressure based on a target inflow rate of fluid through the inflow pathway; comparing the calculated inflow pressure with the measured inflow pressure; and if the measured inflow pressure exceeds the calculated inflow pressure, automatically adjusting a bypass flow control valve between the inflow pathway and the waste outlet.

[0006] In some aspects, the techniques described herein relate to an endoscope including: an inflow pathway configured to receive a fluid; an inflow device fluidly coupled to the inflow pathway and configured to pump fluid therethrough; a waste pathway for receiving the fluid; a bypass pathway extending between the waste pathway and the inflow pathway; and a bypass valve on the waste pathway, the bypass valve actuatable to shunt the fluid from the inflow pathway to the waste pathway.

[0007] In some aspects, the techniques described herein relate to a urological fluid management system including: an inflow device actuatable for pumping a fluid through an inflow pathway with an inflow pressure sensor; an outflow device actuatable for pumping a fluid through on outflow pathway with an outflow pressure sensor; a bypass flow valve fluidly connected between the inflow pathway and the outflow pathway, the bypass flow valve actuatable for altering pressure in the system; and a medical device fluidly connected to the inflow pathway and the outflow pathway.

[0008] In some aspects, the techniques described herein relate to a method of using a urological fluid management system having an inflow pathway and an outflow pathway, wherein the system is configured for regulating inter-renal pressure and maintaining a desired fluid outflow, the method including: receiving a measured inflow pressure of fluid flow through the inflow pathway; determining a calculated inflow pressure based on a target inflow rate of fluid through the inflow pathway; comparing the calculated inflow pressure with the measured inflow pressure; and if the measured inflow pressure exceeds the calculated inflow pressure, automatically adjusting a bypass flow control valve between the inflow pathway and the outflow pathway.

[0009] In some aspects, the techniques described herein relate to a urological fluid management system including: an inflow device actuatable for pumping a fluid through an inflow pathway with inflow pressure sensor; an outflow device actuatable for pumping a fluid through on outflow pathway with an outflow pressure sensor; and an automatic bypass flowvalve fluidly connected between the inflow pathway and the outflow pathway, the bypass flow valve actuatable for altering pressure in the system.

[0010] In some aspects, the techniques described herein relate to a method of using a urological fluid management system having an inflow pathway, an outflow pathway, and a waste outlet, wherein the system is configured for regulating inter-renal pressure and maintaining a desired fluid outflow, the method including: receiving a measured inflow pressure of fluid flow through the inflow pathway; determining a calculated inflow pressure based on a target inflow rate of fluid through the inflow pathway; comparing the calculated inflow pressure with the measured inflow pressure; and if the measured inflow pressure exceeds the calculated inflow pressure, automatically adjusting a bypass flow control valve between the inflow pathway and the waste outlet.

[0011] In some aspects, the techniques described herein relate to an endoscope including: an inflow pathway configured to receive a fluid; an inflow device fluidly coupled to the inflow pathway and configured to pump fluid therethrough; a waste pathway for receiving the fluid; a bypass pathway extending between the waste pathway and the inflow pathway; and a bypass valve on the waste pathway, the bypass valve actuatable to shunt the fluid from the inflow pathway to the waste pathway.

[0012] In some aspects, the techniques described herein relate to a urological fluid management system including: an inflow device actuatable for pumping a fluid through an inflow pathway with an inflow pressure sensor; an outflow device actuatable for pumping a fluid through on outflow pathway with an outflow pressure sensor; a bypass flow valve fluidly connected between the inflow pathway and the outflow pathway, the bypass flow valve actuatable for altering pressure in the system; and a medical device fluidly connected to the inflow pathway and the outflow pathway.BRIEF DESCRIPTION OF THE DRAWINGS

[0013] In the drawings, which are not necessarily drawn to scale, like numerals may describe similar components in different views. Like numerals having different letter suffixes may represent different instances of similar components. The drawings illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in the present document.

[0014] FIG. 1 illustrates a urological fluid management system in an example.

[0015] FIGS. 2A-2C illustrates a bypass flow control valve for use in a urological fluid management system in an example.

[0016] FIG. 3 illustrates a urological fluid management system in an example.

[0017] FIG. 4 illustrates a flow chart of a method of regulating pressure in a urological fluid management system in an example.

[0018] FIG. 5 illustrates a calibration curve in an example.

[0019] FIG. 6 illustrates a flow chart of a method of regulating pressure in a urological fluid management system in an example.

[0020] FIG. 7 illustrates a flow chart of a method of regulating pressure in a urological fluid management system in an example.

[0021] FIG. 8 illustrates a urological fluid management system in an example.

[0022] FIG. 9 illustrates a flow chart of a method of regulating pressure in a urological fluid management system in an example.

[0023] FIG. 10 illustrates a calibration curve in an example.

[0024] FIG. 11 illustrates a computer system in an example.

[0025] FIG. 12 illustrates a schematic of a computer-based clinical decision support system in an example.DETAILED DESCRIPTION

[0026] The present disclosure describes, among other things, a method of controlling pressure in a urological fluid management system.

[0027] Disclosed is a method of controlling pressure in a urological fluid management system. Standard urological fluid management systems have two methods of managing pressure: (1) isostatic pressure control using pressurized chambers with IV bags to provide consistent static pressure and (2) peristaltic pump driven irrigation and / or suction used to adjust flow rates and achieve target pressure.

[0028] This new methodology uses a bypass flow control valve between the inflow and outflow pathways, creating a third flow pathway to help control pressure in the system as a whole. The use of the bypass flow control valve is controlled by a feedback control algorithm.

[0029] This can allow for high pressure in the pathways and / or at the surgical site to be mitigated with automatic adjustment of flow rate. This can occur by automatic adjustmentof the bypass flow control valve based on pressure sensor(s) in the pathway and flow rate of the irrigation pump.

[0030] In urological procedures, fluid is often used in irrigation and suction within the urological system. Various fluids can be used to irrigate the urological surgical site and medical devices being used at that surgical site. Those fluids can be run into the system for irrigation, and then suctioned out of the system, as desired to work with the urological device, and as the surgeon desired during an operation.

[0031] Generally, such fluids used in irrigation, aspiration, and / or suction, are driven through small lumens during such a procedure. Management of that fluid can help aid in the surgical process, help flush out the surgical site, help move various debris such as stone fragments, and overall be beneficial to the surgery. However, due to the small lumens through which the fluid is driven, pressure and flow rate of the fluid should be monitored and controlled.

[0032] The system and methods discussed herein are designed to help reduce the risk of high-pressure situations in irrigation and aspiration / suction pathways in such a urological fluid flow system. The proposed systems and methods can leverage a bypass channel coupled with a motorized valve for automated regulation of potential high-pressure situations. The motorized valve can be regulated through various pressure system feedback control algorithms or “loops”.

[0033] Current urological fluid management systems have two methods of managing pressure: either isostatic pressure control or peristaltic pump driven irrigation and / or suction. In isostatic pressure control, pressurized chambers with IV bags for consistent static pressure are used throughout the urological fluid system. In the second, peristaltic method, a pressure sensor is used in line and flow rates are adjusted to achieve a target pressure.

[0034] With a peristaltic approach, an inflow flow rate (Qi) and a target intrarenal pressure (target Pirp) are set by a user. The system then measure pressure at the tip of a scope inside the kidney (measured Pirp), and compares that measured pressure to the target Pirp. The system can modulate the outflow rate (e.g., suction rate) accordingly. For example, if a Pirp is measure higher than a target Pirp, the outflow rate can be increased in the system to reduce overall system pressure.

[0035] The systems and methods discussed herein use an alternative approach to controlling pressure in a urological fluid flow system using a motorized control valve. This third “bypass” flow pathway through the motorized valve can be controlled via feedbackalgorithm. In a first example, the bypass flow pathway is placed between inflow and outflow pathways. In a second example, the bypass flow pathway is placed between the inflow pathway and a waste pathway.

[0036] In either iteration, the bypass flow pathway can be controlled by an automated feedback loop. This can allow for high pressures in the pathways and surgical site to be mitigated by automatically adjusting flow rate therethrough. Specifically, the motorized control valve can be adjusted based on reading from the pressure sensors in the inflow pathway, outflow pathway, and / or the flow rate of the inflow device.

[0037] The methods and systems discussed herein have several advantages, some of which are unexpected. First, the use of a bypass flow pathway enables an outflow driven pressure control algorithm while providing pressure relief in instances where the outflow pathway becomes blocked. This is also the case if the outflow device cannot reduce pressure in the system quickly enough. Second, the bypass flow pathway and associated methods herein provide a secondary flow control mechanism to reduce inflow pressure without reversing the flow of the inflow device. This can help reduce the risk of contaminated fluid traveling back through the inflow pathway. This can also help allow for fixed flow rates to be set for both the inflow device and the outflow device. Third, the bypass flow pathway and associated methods can provide a mechanism by which clogs, kinks, and other challenges with the outflow pathway can be reduced due to redirected inflow rates through the bypass flow control valve .

[0038] FIG. 1 illustrates a urological fluid management system 100 in an example. The system 100 can include an inflow pathway 110 with an inflow device 112 and sensors 114, 116 in addition to an outflow pathway 120 with an outflow device 122 and sensors 124, 126. The inflow pathway 110 can receive fluid from a supply 118. The outflow pathway can be connected to waste outlet 128. The inflow pathway 110 and the outflow pathway 120 can be fluidly coupled to the scope 130 in the kidney. A bypass pathway 140 with bypass flow control valve 145 can connect the inflow pathway 110 and the outflow pathway 120. A control panel 150 can be used to manipulate the flow of fluid in the system 100.

[0039] The system 100 can be a lithotripsy system, such as for use with a lithotripter or other urological device. For example, the device can be for detection, treatment, breakup, and / or removal of stones, calculi, or other buildup. The device can include the scope 130 located in or near the treatment site, such as the kidney. The pressure at the scope 130 can be indicative of the pressure at the kidney or other treatment site.

[0040] The system 100 includes both an inflow pathway 110 and an outflow pathway 120. The inflow pathway 110 can be irrigation tubing, such as for flowing an irrigation fluid (e.g., saline, or other appropriate fluid) into the system 100 and through the scope 130. The outflow pathway 120 can be suction tubing, such as connected to a vacuum or other pressure source for flowing fluid out of the system 100 from the treatment site and scope 130. In an example, each of the inflow pathway 110 and the outflow pathway 120 can be lumen(s) of an endoscope.

[0041] The inflow pathway 110 can include the inflow device 112. The inflow device 112 can be actuatable for pumping irrigation fluid, such as saline, into the system 100, such as from a fluid source.

[0042] The inflow pathway 110 can additionally include one or more sensors 114, 116. These can be, for example, pressure sensors, flow sensors, or combinations thereof. These sensors 114, 116, can provide sensor data, such as for interpretation by a controller or computer, such as the control panel 150. The sensors 114, 116, can be inline or parallel sensors as desired. The sensors 114, 116, can aid in monitoring of the flow rate and pressure of the fluid in the inflow pathway 110.

[0043] The outflow pathway 120 can include the outflow device 122. The outflow device 122 can be actuatable for pumping out fluid that has be cycled through the inflow pathway and the treatment site. In some cases, such outgoing fluid can include fragments or pieces of calculi or other debris that has been treated. The outflow device 122 can be used to suction such fluid and additional material out of the system 100 towards a waste outlet.

[0044] The sensors 124 and sensors 126 can be for example, pressure sensors, flow sensors, or combinations thereof. These sensors 124, 126, can provide sensor data, such as for interpretation by a controller or computer, such as the control panel 150. The sensors 124, 126, can be inline or parallel sensors as desired. The sensors 124, 126, can aid in monitoring of the flow rate and pressure of the fluid in the outflow pathway 120.

[0045] Shown in FIG. 1, the bypass pathway 140 can extend between the inflow pathway 110 and the outflow pathway 120. In another example, the bypass pathway 140 can instead extend between the inflow pathway 110 and a waste fluid pathway. In either case, the bypass pathway 140 can include the bypass flow control valve 145. The bypass flow control valve 145 can be a mechanical valve that is automated or semi-automated. The bypass flow control valve 145 can be, for example, a motorized valve that can be switched automaticallyby a controller or computer such as the control panel 150. The bypass flow control valve 145 can be changeable between an open position and a closed position.

[0046] FIGS. 2A-2C illustrates an example of the bypass flow control valve 145 for use in the urological fluid management system 100. Here, the bypass flow control valve 145 can be a motorized control valve actuatable by a motor, which allows for variable flow rates set by a pump. The bypass flow control valve 145 can have valve walls 213.

[0047] FIGS. 2 A and 2B depict a motorized needle valve 145 A design where the needle 210 is driven by either a motor 212 or a linear actuator (such as connected by a shaft or coupler 211) to adjust the orifice 214 created by the needle 210 tip within the valve’s flow pathway 216. Here, the valve 145A is fluid-contacting.

[0048] FIG. 2C depicts a motorized adjustable pinch valve 145B where a linear actuator 220 drive a plunger 222 to occlude an inserted tube 224. This valve 145B would be non-fluid-contacting.

[0049] In either case, the motorized flow control bypass flow control valve 145 can interface with the inflow pathway 110 and the outflow pathway 120 in the system 100. The bypass pathway 140 with the bypass flow control valve 145 can shunt inflow fluid to the outflow pathway 120 when needed to reduce pressure in the system 100 overall and at the surgical site at the scope 130 tip. This can help provide a way to reduce clogging in the outflow pathway 120.

[0050] The control panel 150 can be connected to or include a computer or other controller that is optionally in communication with the sensors 114, 116, 124, 126, the inflow device 112, the outflow device 122, the scope 130, and the bypass flow control valve 145. The control panel 150 can optionally include a user interface for operator interaction and / or provision of data. The control panel 150 can be operable to automatically adjust the bypass flow control valve 145 based on pressure and flow data received from the sensors in the system 100.

[0051] Bypass Flow Control Valve Between Inflow Pathway and Outflow Pathway

[0052] FIGS. 3 to 7 depict various methods of controlling pressure in a urological fluid flow system using a bypass pathway with an automatic motorized valve, where the bypass pathway extends between in inflow pathway and an outflow pathway.

[0053] FIG. 3 illustrates a urological fluid management system 300 in an example. The system 300 can include an inflow pathway 310 with inflow device 312, sensors 314, an outflow pathway 320 with outflow device 322, sensors 324, a supply 318, a waste outlet 328,a scope 330 with an intrarenal sensor 334, a bypass line 340 with a bypass flow control valve 345, and a controller 350. The system 300 can be similar to the system 100 described above, contain similar components, and be connected in a similar fashion, except where otherwise noted.

[0054] Here, the bypass flow control valve 345 can act as a shunt between the inflow pathway 310 and the outflow pathway 320. Generally, the bypass flow control valve 345 can be closed during operation of the scope 330 and associated instruments at the surgical site, and fluid (e.g., irrigation fluid such as saline) can flow from the supply 318 through the inflow pathway 310, through the surgical site, and out the outflow pathway 320 to the waste outlet 328.

[0055] The sensors 314, 324, and 334 can collect pressure data as the fluid flows through the system. The inflow pressure sensor 314 can detect the pressure of fluid flowing down the inflow pathway 310 (e.g., inflow pressure, Pi), while the outflow pressure sensor 324 can detect the pressure of fluid flowing down the outflow pathway 320 (e.g., outflow pressure, Po). The intrarenal pressure sensor 334 can detect the pressure of fluid at the scope 330 tip, such as at the surgical site (e.g., intrarenal pressure, Pirp).

[0056] The detected inflow pressure (Pi) and the detected intrarenal pressure, (Pirp) can be monitored and reported, such as to the controller 350. Based on various feedback control concepts, discussed in detail with reference to FIGS. 4-7 below, the controller can automatically open or close the bypass flow control valve 345 as desired to help regulate the overall pressure in the system 300 and at the kidney (Pirp).

[0057] FIG. 4 illustrates a flow chart of a pressure loop 400 (“PID”) for regulating pressure in a urological fluid management system (such as system 300) in an example. Here, the pressure loop 400 of the system can include a bypass flow control valve rate 442 (Qv) driven and a target outflow rate 430 initially set by the user.

[0058] In the pressure loop 400, inflow pressure feedback can be used in a control loop with an inflow to outflow shunt valve such as the bypass flow control valve 440. Here, the target inflow rate 410, the inflow pressure 412, the intrarenal pressure 422, the target intrarenal pressure 420, and the target outflow rate 430 are all taken into account when determining whether to automatically adjust the bypass flow control valve and adjust the flow and overall pressure in the system between the inflow pathway and the outflow pathway.

[0059] In the pressure loop 400, the pressure loop can open, close, or adjust the bypass flow control valve 440 and adjust the bypass flow control valve rate 442 to reduce high pressure conditions in the inflow pathway, such as the inflow pressure 412.

[0060] For example, the pressure loop 400 can be used to help regulate pressure in a urological fluid management system. In the pressure loop 400, the target inflow rate 410 (Qi) can be used to determine the inflow motor control 418. The target inflow rate 410 can also be used in the calibration curve calculation 411 to calculate a calculated inflow pressure 414 (Pexp). The calculated inflow pressure 414 can be inputted into the pressure loop 400 calculation 416 along with the actual inflow pressure 412 (Pi), the actual intrarenal pressure 422 (Pirp, actual), and the target intrarenal pressure 420 (Pirp, target), to determine a change in inflow pressure, which can help determine the desired bypass flow control valve rate 442 (Qv). The bypass flow control valve rate 442 can be compared to a predetermined target outflow rate 430 (Qo) at calculation 431 to determine a modified outflow pressure 432 (Qo, modified) and adjust the outflow motor control 434 and bypass flow control valve 440 accordingly. Each of these steps or considerations is discussed in more detail below.

[0061] To begin, a target inflow rate 410 can be set. The target inflow rate 410 can be a preset value determined by the user. The target inflow rate 410 can correlate to the set inflow motor control 418, e.g., the target inflow rate 410 can be set at the inflow device.

[0062] The target inflow rate 410 can be used at calculation 411 to produce a calculated inflow pressure 414 (Pexp). The calculated inflow pressure 414 can be determined using a calibration curve, such as the curve shown in FIG. 5. FIG. 5 illustrates a calibration curve in an example. The calibration curve of FIG. 5 can be calculated with a present calibration curve of expected pressure versus target inflow rate 410. Shown in FIG. 5, the target inflow rate 410 is expressed in “motor speed (RPM) or signal volage (V)” on the x-axis and calculated inflow pressure 414 is expressed as “discharge pressure” in kPa.

[0063] The actual inflow pressure 412 (Qi) can be monitored and measured, such as by one or more pressure sensors at the inflow device in the system. Similarly, the actual intrarenal pressure 422 (Pirp, actual) can be measured by one or more sensors in or at the target treatment site, such as at a scope tip in the kidney or other location. A target intrarenal pressure 420 (Pirp, target) can also be preset or determined by the user, such as at a controller.

[0064] The inflow pressure 412 and the intrarenal pressure 422 can be compared to the calculated inflow pressure 414 and the target intrarenal pressure 420 at the calculation 416. The inflow pressure 412, the calculated inflow pressure 414 the target intrarenalpressure 420 and the intrarenal pressure 422, can all be taken into account to calculate an appropriate or desired bypass flow control valve rate 442.

[0065] Depending on the calculated bypass flow control valve rate 442, the system can automatically open or closed the motorized control valve proportionally to reduce high pressure conditions in the inflow pathway.

[0066] Meanwhile, a target outflow rate 430 can be set, such as by the user, and may be preset in some cases. The target outflow rate 430 can be a desired rate of flow out of the system, such as through an outflow device. The target outflow rate 430 can be compared at calculation 431 to the calculated bypass flow control valve rate 442, where the bypass flow control valve rate 442 is calculated based on the inflow pressure 412, the calculated inflow pressure 414 the target intrarenal pressure 420 and the intrarenal pressure 422.

[0067] In the example pressure loop 400, if the bypass flow control valve rate 442 is greater than the target outflow rate 430, the target outflow rate 430 can be adjusted to a modified outflow pressure 432. If the bypass flow control valve rate 442 is not greater than the target outflow rate 430, the outflow motor control 434 can remain the same. For example, the bypass flow control valve rate 442 can be compared to the modified outflow pressure 432 to ensure that the outflow has been increased to compensate for the bypass flow control valve rate 442, such that both the bypass flow control valve rate 442 flow and the modified outflow pressure 432 can be directed through the outflow device to waste.

[0068] Overall, the pressure loop 400 can be based on the inflow pressure 412 instead of based on the intrarenal pressure 422. In the pressure loop 400, the intrarenal pressure 422 can be used as an additional input into the pressure loop 400 in addition to the inflow pressure 412. This allows the user to set a preliminary target outflow rate 430. Based on the target outflow rate 430, the algorithm of the pressure loop 400 can automatically adjust the pressure loop 400 and the corresponding bypass flow control valve rate 442.

[0069] FIG. 6 illustrates a flow chart of a pressure loop 600 of regulating pressure in a urological fluid management system in an example. The pressure loop 600 depicts an inter- renal pressure 622 based feedback algorithm with an alternative high pressure flow rate loop algorithm based on the inflow rate alter the to control valve flow rate. Here, the target outflow rate can be driven by an inter-renal pressure algorithm until a preset high-pressure condition is detected at the inter-renal site. At that point, the feedback loop based on the input flow rate can be enabled, driving a change in the motorized control valve rate.

[0070] More specifically, the pressure loop 600 can take into account the measured inter-renal pressure 622 (Pirp, actual) and the target inter-renal pressure 620 (Pirp, target), in addition to a target inflow rate 610 (Qi) and an actual inflow pressure 612 (Pi). The inflow motor control 618 can affect the target inflow rate 610.

[0071] Here, the target inflow rate 610 is used to calculate the calculated inflow pressure 614 (Pexp) with the calibration curve calculation 611, similar as discussed above with reference to FIG. 5. The calculated inflow pressure 614 is compared to the actual inflow pressure 612 at comparison 615. At this comparison 615, the inter-renal pressure 622 is compared to a preset threshold. If the inter-renal pressure 622 is above the threshold, and / or if the actual inflow pressure 612 is larger than the calculated inflow pressure 614, then calculation 616B is done. Conversely, if the inter-renal pressure 622 is below the preset threshold and the actual inflow pressure 612 is lower than the calculated inflow pressure 614, then calculation 616A is done.

[0072] At calculation 616A, the target inter-renal pressure 620 is taken into account along with the inter-renal pressure 622 to calculate a modified target outflow rate 632 (Qo). The outflow motor control 634 is adjusted according to the modified target outflow rate 632.

[0073] If, however, calculation 616B is done, the actual inflow pressure 612, the inter-renal pressure 622, and the calculated inflow pressure 614 are taken into account, and a bypass flow control valve flow rate 642 (Qv) is calculated. The bypass flow control valve 640 is adjusted accordingly. Additionally, the bypass flow control valve flow rate 642 is compared to the actual outflow rate 633 (Po). If the bypass flow control valve flow rate 642 is equal to the actual outflow rate 633, then a new modified target outflow rate 632 is calculated, and the outflow motor control 634 is adjusted accordingly.

[0074] In the pressure loop 600 the bypass flow control valve 640 can be used as an inflow to outflow shunt valve. The overall flow rate in the pressure loop 600 can be driven by the algorithm at calculation 616A, until a high-pressure condition is detected such as at the inter-renal pressure 622, in which case the algorithm at calculation 616B is activated. This can engage the bypass flow control valve 640 to alleviate pressure at the inter-renal site.

[0075] FIG. 7 illustrates a flow chart of a pressure loop 700 and method of regulating pressure in a urological fluid management system in an example. The pressure loop 700 of FIG. 7 can include both an inter-renal pressure and inflow pressure feedback loop, with an inflow to outflow shunt valve, similar to FIG. 6. However, in FIG. 7, de-clogging mechanisms can be incorporated into the pressure loop 700 and method here.

[0076] In the pressure loop 700, the target inflow rate 710 (Qi), the inflow pressure 712 (Pi), and the measured inter-renal pressure 722 (Pirp) can be taken into account in the use of the bypass flow control valve 740 and overall pressure regulation in the pressure loop 700 of a urological fluid management system.

[0077] Similar to the methods discussed above, the target inflow rate 710 can be used to calculate a calculated inflow pressure 714 at the calibration curve calculation 711. The inflow pressure 712 can be compared to the calculated inflow pressure 714 at the comparison 715. The measured inter-renal pressure 722 can also be checked against a predetermined threshold pressure value at the comparison 715. If the inflow pressure 712 is greater than the calculated inflow pressure 714, and / or if the measured inter-renal pressure 722 is above the predetermined threshold, calculation 716A can be done.

[0078] Calculation 716A can take into account the inflow pressure 712, the measured inter-renal pressure 722, and the calculated inflow pressure 714, to produce a bypass flow control valve flow rate 742 (Qv). The bypass flow control valve 740 can be adjusted accordingly.

[0079] The bypass flow control valve flow rate 742 can be used in determination 743 for detection of a clog in the system. If a clog is detected, the target outflow rate 730 (Qo) can be adjusted to a desired de-clog outflow rate 733. The outflow motor control 734 can be adjusted accordingly to accomplish the desired de-clog outflow rate 733.

[0080] If a clog is not detected, the target outflow rate 730 can be compared to the bypass flow control valve flow rate 742. If the target outflow rate 730 is not equal to the bypass flow control valve flow rate 742, desired modified target outflow rate 732 can be adjusted so the two values are equal.

[0081] Alternatively, if the inflow pressure 712 is less than the calculated inflow pressure 714 and the measured inter-renal pressure 722 is below the predetermined threshold, then calculation 716B can be done. Calculation 716B can take into account the target inter- renal pressure 720 (Pirp) and the measured inter-renal pressure 722 to produce a desired modified target outflow rate 732. The bypass flow control valve 740 can be adjusted accordingly.

[0082] Overall, in the pressure loop 700, the methods can be similar to those in FIG. 6, with the additional subroutine that checks if a clog is detected. In no clog is detected, the system can default to the methods discussed with reference to FIG. 6, where the bypass flow control valve flow rate 742 is set equal to the target outflow rate 730. However, if a clog isdetected in the outflow tubing pathway or scope, then the flow rate can be adjusted through the bypass flow control valve 740 such that the bypass flow control valve flow rate 742 is greater than the target outflow rate 730.

[0083] In the pressure loop 700, the difference between the bypass flow control valve flow rate 742 and the target outflow rate 730 can be a flow rate redirected backwards, towards the scope, in the outflow pathway.

[0084] Bypass Flow Control Valve Between Inflow Pathway and Waste Pathway

[0085] FIGS. 8 to 10 depict various methods of controlling pressure in a urological fluid flow system using a bypass pathway with an automatic motorized valve, where the bypass pathway extends between in inflow pathway and a waste pathway.

[0086] The concepts discussed with reference to FIG. 8 to 10 present an alternative approach to controlling pressure in fluid management with the addition of a bypass flow control valve placed between the inflow pathway and a waste canister. This waste canister can be placed on the outlet side of the outflow peristaltic pump. This can add a third flow pathway through this valve in addition to inflow and outflow peristaltic pumps which can be controlled by a feedback control algorithm. This concept can allow high pressure in the inflow pathway and surgical site to be mitigated by automatically adjusting flow rate through a bypass flow control valve based on the reading of a pressure sensor in the pathway and the flow rate of the irrigation pump.

[0087] Such an approach can enable an outflow-driven pressure control algorithm while providing pressure relief in instances where the outflow pathway is blocked, or the outflow device cannot reduce pressure quickly enough, which may result in high inflow pressure. Moreover, such an approach can provide a secondary flow control mechanism to reduce inflow pressure without reversing the flow of the inflow device. This can help reduce the risk of contaminated fluid traveling back through the inflow pathway.

[0088] An example urological fluid management system 800 is shown in FIG. 8. The system 800 can include an inflow pathway 810 with inflow device 812, sensor 814, an outflow pathway 820 with outflow device 822, sensors 824, a supply 818, a waste outlet 828, a scope 830, a bypass line 840 with a bypass flow control valve 845, and a controller 850. The system 800 can be similar to the system 300 described above, contain similar components, and be connected in a similar fashion, except where otherwise noted.

[0089] Here, the bypass flow control valve 845 can act as a shunt between the inflow pathway 810 and the waste outlet 828. Generally, the bypass flow control valve 845 can beclosed during operation of the scope 830 and associated instruments at the surgical site, and fluid (e.g., irrigation fluid such as saline) can flow from the supply 818 through the inflow pathway 810, through the surgical site, and out the outflow pathway 820 to the waste outlet 828.

[0090] The sensors 814, 824, and 834 can collect pressure data as the fluid flows through the system. The inflow pressure sensor 814 can detect the pressure of fluid flowing down the inflow pathway 810 (e.g., inflow pressure, Pi), while the outflow pressure sensor 824 can detect the pressure of fluid flowing down the outflow pathway 820 (e.g., outflow pressure, Po). The intrarenal pressure sensor 834 can detect the pressure of fluid at the scope 830 tip, such as at the surgical site (e.g., intrarenal pressure, Pirp).

[0091] The detected inflow pressure (Pi) and the detected intrarenal pressure, (Pirp) can be monitored and reported, such as to the controller 850. Based on various feedback control concepts, discussed in detail with reference to FIG. 9 below, the controller can automatically open or close the bypass flow control valve 845 as desired to help regulate the overall pressure in the system 800 and at the kidney (Pirp).

[0092] In the system 800, the bypass flow control valve 845 can be a bypass flow control valve that interfaces with the inflow pathway 810 and the waste outlet 828 line. This effectively shunts inflow to the waste outlet 828, thereby reducing pressure in the system and the surgical site. This bypass flow control valve can normally be closed and can be actuated based on system feedback control loops based on the inflow pressure as reported by the inflow pressure sensor.

[0093] FIG. 9 illustrates a flow chart of a pressure loop 900 and method of regulating pressure in a urological fluid management system in an example. The pressure loop 900 depicts an inter-renal pressure 922 based feedback algorithm with an alternative high pressure flow rate loop algorithm based on the inflow rate alter the motorized control valve flow rate.

[0094] In the pressure loop 900, the outflow motor control 934 can be adjusted according to the measured inter-renal pressure 922 (Pirp, actual) and the target inter-renal pressure 920 (Pirp, target), while both the inflow motor control 918 and the bypass flow control valve 940 can be adjusted based on the target inflow rate 910 (Qi) and the actual inflow pressure 912 (Pi).

[0095] In the pressure loop 900, the pressure loop can open, close, or adjust the bypass flow control valve 940 and adjust the bypass flow control valve rate 942 to reduce high pressure conditions in the inflow pathway, such as the inflow pressure 912.

[0096] For example, the pressure loop 900 can be used to help regulate pressure in a urological fluid management system. In the pressure loop 900, the target inflow rate 910 (Qi) can be used to determine the inflow motor control 918. The target inflow rate 910 can also be used in the calibration curve calculation 911 to calculate a calculated inflow pressure 914 (Pexp). The calculated inflow pressure 914 can be inputted into the pressure loop 900 calculation 916A along with the actual inflow pressure 912 (Pi) to determine a change in inflow pressure, which can help determine the desired bypass flow control valve rate 942 (Qv). The bypass flow control valve 940 can be adjusted accordingly. Simultaneously, the actual intrarenal pressure 422 (Pirp, actual), and the target intrarenal pressure 420 (Pirp, target) can be taken into account at the calculation to help determined a modified target outflow rate (Qo). The outflow motor control 934 can be adjusted accordingly. Each of these steps or considerations is discussed in more detail below.

[0097] The pressure loop 900 can used as an inflow pressure feedback control loop to waste shunt with the motorized control valve. To begin, a target inflow rate 910 can be set. The target inflow rate 910 can be a preset value determined by the user. The target inflow rate 910 can correlate to the set inflow motor control 918, e.g., the target inflow rate 910 can be set at the inflow device.

[0098] The target inflow rate 910 can be used at calculation 911 to produce a calculated inflow pressure 914 (Pexp). The calculated inflow pressure 914 can be determined using a calibration curve, such as the curve shown in FIG. 10. The calibration curve of FIG. 10 can be calculated with a present calibration curve of expected pressure versus target inflow rate 910. Shown in FIG. 10, the target inflow rate 910 is expressed in “motor speed (RPM) or signal volage (V)” on the x-axis and calculated inflow pressure 914 is expressed as “discharge pressure” in kPa.

[0099] The actual inflow pressure 912 (Qi) can be monitored and measured, such as by one or more pressure sensors at the inflow device in the system. The inflow pressure 912 and the calculated inflow pressure 914 can be taken into account to calculate an appropriate or desired bypass flow control valve rate 442 (Qv) at the calculation 916A.

[0100] Depending on the calculated bypass flow control valve rate 942, the system can automatically open or closed the motorized control valve proportionally to reduce high pressure conditions in the inflow pathway. The bypass flow control valve 940 can be connected to a waste outlet, allowing for shunting of fluid from the inflow pathway to the waste outlet when the bypass flow control valve 940 is open.

[0101] This system control loop algorithm can therefore react to any unexpectedly high inflow pressure 912 to open the bypass flow control valve rate 942 to reduce the actual inflow pressure 912 through the bypass flow control valve 940 directed towards waste. Ins some cases, this unexpectedly high pressure could be caused by clogs in the outflow pathway which could also use the same calibration curve for clog detection, such as the calibration curve of FIG. 10.

[0102] In some cases, the inflow pressure feedback control loop to waste shunt can be accomplished with a pinch valve; in this case, the bypass flow control valve 940 can be a pinch valve. Such a pinch valve can have an on / off pinch valve design to full open a bypass line from the inflow pathway to the waste outlet. Such a pinch valve could be oscillated by the system rapidly to indirectly limit flow through the valve as desired.

[0103] Meanwhile, the actual intrarenal pressure 922 (Pirp, actual) can be measured by one or more sensors in or at the target treatment site, such as at a scope tip in the kidney or other location. A target intrarenal pressure 920 (Pirp, target) can also be preset or determined by the user, such as at a controller. The actual intrarenal pressure 922 can be compared to the target intrarenal pressure 920 at the calculation 916B. Based on the calculation 916B, a modified target outflow rate 932 (Qo) can be determined. The outflow motor control 934 can be adjusted accordingly.

[0104] Computer Example

[0105] FIG. 11 is a block diagram of a typical, general -purpose computer 1100 that may be programmed into a special purpose computer suitable for implementing one or more embodiments of the manifest record generating program disclosed herein. The manifest record generating program described above may be implemented on any general-purpose processing component, such as a computer with sufficient processing power, memory resources, and communications throughput capability to handle the necessary workload placed upon it. The computer 1100 includes a processor 1102 (which may be referred to as a central processor unit or CPU) that is in communication with memory devices including secondary storage 1104, read only memory (ROM) 1106, random access memory (RAM) 1108, input / output (VO) devices 1110, and network connectivity devices 1112. The processor 1102 may be implemented as one or more CPU chips or may be part of one or more application specific integrated circuits (ASICs).

[0106] The secondary storage 1104 is typically comprised of one or more disk drives or tape drives and is used for non-volatile storage of data and as an over-flow data storagedevice if RAM 1108 is not large enough to hold all working data. Secondary storage 1104 may be used to store programs that are loaded into RAM 1108 when such programs are selected for execution. The ROM 1106 is used to store instructions and perhaps data that are read during program execution. ROM 1106 is a non-volatile memory device that typically has a small memory capacity relative to the larger memory capacity of secondary storage 1104. The RAM 1108 is used to store volatile data and perhaps to store instructions. Access to both ROM 1106 and RAM 1108 is typically faster than to secondary storage 1104.

[0107] The devices described herein may be configured to include computer-readable non-transitory media storing computer readable instructions and one or more processors coupled to the memory, and when executing the computer readable instructions configure the computer 1100 to perform method steps and operations described above with reference to FIG. 3 to FIG. 9. The computer-readable non-transitory media includes all types of computer readable media, including magnetic storage media, optical storage media, flash media and solid-state storage media.

[0108] It should be further understood that software including one or more computerexecutable instructions that facilitate processing and operations as described above with reference to any one or all of steps of the disclosure may be installed in and sold with one or more servers and / or one or more routers and / or one or more devices within consumer and / or producer domains consistent with the disclosure. Alternatively, the software may be obtained and loaded into one or more servers and / or one or more routers and / or one or more devices within consumer and / or producer domains consistent with the disclosure, including obtaining the software through physical medium or distribution system, including, for example, from a server owned by the software creator or from a server not owned but used by the software creator. The software may be stored on a server for distribution over the Internet, for example.

[0109] Also, it will be understood by one skilled in the art that this disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the description or illustrated in the drawings. The embodiments herein are capable of other embodiments, and capable of being practiced or carried out in various ways. Also, it will be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of "including," "comprising," or "having" and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Unless limited otherwise, the terms"connected," "coupled," and "mounted," and variations thereof herein are used broadly and encompass direct and indirect connections, couplings, and mountings. In addition, the terms "connected" and "coupled”, and variations thereof are not restricted to physical or mechanical connections or couplings. Further, terms such as up, down, bottom, and top are relative, and are employed to aid illustration, but are not limiting.

[0110] The components of the illustrative devices, systems and methods employed in accordance with the illustrated embodiments may be implemented, at least in part, in digital electronic circuitry, analog electronic circuitry, or in computer hardware, firmware, software, or in combinations of them. These components may be implemented, for example, as a computing program product such as a computing program, program code or computer instructions tangibly embodied in an information carrier, or in a machine-readable storage device, for execution by, or to control the operation of, data processing apparatus such as a programmable processor, a computer, or multiple computers.

[0111] A computing program may be written in any form of programming language, including compiled or interpreted languages, and it may be deployed in any form, including as a stand-alone program or as a module, component, subroutine, or other unit suitable for use in a computing environment. A computing program may be deployed to be executed on one computer or on multiple computers at one site or distributed across multiple sites and interconnected by a communication network. Also, functional programs, codes, and code segments for accomplishing the techniques described herein may be easily construed as within the scope of the present disclosure by programmers skilled in the art. Method steps associated with the illustrative embodiments may be performed by one or more programmable processors executing a computing program, code, or instructions to perform functions (e.g., by operating on input data and / or generating an output). Method steps may also be performed by, and apparatus may be implemented as, special purpose logic circuitry, e.g., an FPGA (field programmable gate array) or an ASIC (application-specific integrated circuit), for example.

[0112] The various illustrative logical blocks, modules, and circuits described in connection with the embodiments disclosed herein may be implemented or performed with a general -purpose processor, a digital signal processor (DSP), an ASIC, a FPGA or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions described herein. A general- purpose processor may be a microprocessor, but in the alternative, the processor may be anyconventional processor, controller, microcontroller, or state machine. A processor may also be implemented as a combination of computing devices, e.g., a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration.

[0113] Processors suitable for the execution of a computing program include, by way of example, both general and special purpose microprocessors, and any one or more processors of any kind of digital computer. Generally, a processor will receive instructions and data from a read-only memory or a random-access memory or both. The essential elements of a computer are a processor for executing instructions and one or more memory devices for storing instructions and data. Generally, a computer will also include, or be operatively coupled to receive data from or transfer data to, or both, one or more mass storage devices for storing data, e.g., magnetic, magneto-optical disks, or optical disks. Information carriers suitable for embodying computing program instructions and data include all forms of non-volatile memory, including by way of example, semiconductor memory devices, e.g., electrically programmable read-only memory or ROM (EPROM), electrically erasable programmable ROM (EEPROM), flash memory devices, and data storage disks (e.g., magnetic disks, internal hard disks, or removable disks, magneto-optical disks, and CD-ROM and DVD-ROM disks). The processor and the memory may be supplemented by or incorporated in special purpose logic circuitry.

[0114] Those of skill in the art understand that information and signals may be represented using any of a variety of different technologies and techniques. For example, data, instructions, commands, information, signals, bits, symbols, and chips that may be referenced throughout the above description may be represented by voltages, currents, electromagnetic waves, magnetic fields or particles, optical fields or particles, or any combination thereof.

[0115] Those of skill in the art further appreciate that the various illustrative logical blocks, modules, circuits, and algorithm steps described in connection with the embodiments disclosed herein may be implemented as electronic hardware, computer software, or combinations of both. To clearly illustrate this interchangeability of hardware and software, various illustrative components, blocks, modules, circuits, and steps have been described above generally in terms of their functionality. Whether such functionality is implemented as hardware or software depends upon the particular application and design constraints imposed on the overall system. Skilled artisans may implement the described functionality in varyingways for each particular application, but such implementation decisions should not be interpreted as causing a departure from the scope of the disclosure. A software module may reside in random access memory (RAM), flash memory, ROM, EPROM, EEPROM, registers, hard disk, a removable disk, a CD-ROM, or any other form of storage medium known in the art. An exemplary storage medium is coupled to the processor such the processor may read information from, and write information to, the storage medium. In the alternative, the storage medium may be integral to the processor. In other words, the processor and the storage medium may reside in an integrated circuit or be implemented as discrete components.

[0116] As used herein, “machine-readable medium” means a device able to store instructions and data temporarily or permanently and may include, but is not limited to, random-access memory (RAM), read-only memory (ROM), buffer memory, flash memory, optical media, magnetic media, cache memory, other types of storage (e.g., Erasable Programmable Read-Only Memory (EEPROM)), and / or any suitable combination thereof. The term “machine-readable medium” should be taken to include a single medium or multiple media (e.g., a centralized or distributed database, or associated caches and servers) able to store processor instructions. The term “machine-readable medium” shall also be taken to include any medium, or combination of multiple media, that is capable of storing instructions for execution by one or more processors, such that the instructions, when executed by one or more processors cause the one or more processors to perform any one or more of the methodologies described herein. Accordingly, a “machine-readable medium” refers to a single storage apparatus or device, as well as “cloud-based” storage systems or storage networks that include multiple storage apparatus or devices. The term “machine- readable medium” as used herein excludes signals per se.

[0117] FIG. 12 shows a schematic diagram of an exemplary computer-based clinical decision support system (CDSS) 1200 that is configured to assess fluid pressure in a urological fluid management system and change a motorized bypass flow control valve based on pressure sensor data within the urological fluid management system. In various embodiments, the CDSS 1200 includes an input interface 1210 through which pressure sensor data which is specific to a patient are provided as input features to an artificial intelligence (Al) model 1220 a processor 1230 which performs an inference operation in which the pressure sensor data is applied to the Al model to generate desired change in the bypass flow control valve, and a user interface (UI) through which change in the bypass flowcontrol valve and overall system fluid flow pressure is communicated to a user, e.g., a clinician.

[0118] In some embodiments, the input interface 1210 may be a direct data link between the CDSS 1200 and one or more medical devices that generate at least some of the input features. For example, the input interface 1210 may transmit data directly to the CDSS during a therapeutic and / or diagnostic medical procedure. Additionally, or alternatively, the input interface 1210 may be a classical user interface that facilitates interaction between a user and the CDSS 1200 For example, the input interface 1210 may facilitate a user interface through which the user may manually enter parameters. Additionally, or alternatively, the input interface 1210 may provide the CDSS 1200 with access to an electronic patient record from which one or more input features may be extracted. In any of these cases, the input interface 1210 is configured to collect one or more of the following input features in association with a specific patient on or before a time at which the CDSS 1200 is used to assess inflow pressure, outflow pressure, fluid flow rate, flow through the bypass valve, or other parameters.

[0119] Based on one or more of the above input features, the processor 1230 performs an inference operation using the Al model to generate one or more flow parameters, such as the input pump rate, the output pump rate, or the motorized flow control valve configuration. For example, input interface 1210 may deliver the inflow rate or outflow rate into an input layer of the Al model which propagates these input features through the Al model to an output layer. The Al model can provide a computer system the ability to perform tasks, without explicitly being programmed, by making inferences based on patterns found in the analysis of data. Al model explores the study and construction of algorithms (e.g., machinelearning algorithms) that may learn from existing data and make predictions about new data. Such algorithms operate by building an Al model from example training data in order to make data-driven predictions or decisions expressed as outputs or assessments.

[0120] There are two common modes for machine learning (ML): supervised ML and unsupervised ML. Supervised ML uses prior knowledge (e.g., examples that correlate inputs to outputs or outcomes) to learn the relationships between the inputs and the outputs. The goal of supervised ML is to learn a function that, given some training data, best approximates the relationship between the training inputs and outputs so that the ML model can implement the same relationships when given inputs to generate the corresponding outputs. Unsupervised ML is the training of an ML algorithm using information that is neitherclassified nor labeled, 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.

[0121] Common tasks for supervised ML are classification problems and regression problems. Classification problems, also referred to as categorization problems, aim at classifying items into one of several category values (for example, is this object an apple or an orange?). Regression algorithms aim at quantifying some items (for example, by providing a score to 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 factorization, and Support Vector Machines (SVM).

[0122] 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.

[0123] Another type of ML is federated learning (also known as collaborative learning) that trains an algorithm across multiple decentralized devices holding local data, without exchanging the data. This approach stands in contrast to traditional centralized machine-learning techniques where all the local datasets are uploaded to one server, as well as to more classical decentralized approaches which often assume that local data samples are identically distributed. Federated learning enables multiple actors to build a common, robust machine learning model without sharing data, thus allowing to address critical issues such as data privacy, data security, data access rights and access to heterogeneous data.

[0124] In some examples, the Al model may be trained continuously or periodically prior to performance of the inference operation by the processor 1230 Then, during the inference operation, the patient specific input features provided to the Al model may be propagated from an input layer, through one or more hidden layers, and ultimately to an output layer that corresponds to the desired bypass valve configuration and flow rate therethrough.

[0125] During and / or subsequent to the inference operation, the desired bypass valve configuration may be communicated to the user via the user interface (UI) and / or automatically cause [an apparatus connected to the processor 1230 for performing a desired action.Various Notes & Examples

[0126] In some aspects, the techniques described herein relate to a method of using a urological fluid management system having an inflow pathway and an outflow pathway, wherein the system is configured for regulating inter-renal pressure and maintaining a desired fluid outflow, the method including: receiving a measured inflow pressure of fluid flow through the inflow pathway; determining a calculated inflow pressure based on a target inflow rate of fluid through the inflow pathway; comparing the calculated inflow pressure with the measured inflow pressure; and if the measured inflow pressure exceeds the calculated inflow pressure, automatically adjusting a bypass flow control valve between the inflow pathway and the outflow pathway.

[0127] In some aspects, the techniques described herein relate to a method, wherein automatically adjusting the bypass flow control valve between the inflow pathway and the outflow pathway includes automatically opening or closing the bypass flow control valve.

[0128] In some aspects, the techniques described herein relate to a method, wherein automatically adjusting the bypass flow control valve between the inflow pathway and the outflow pathway includes partially opening or closing the bypass flow control valve.

[0129] In some aspects, the techniques described herein relate to a method, wherein automatically adjusting the bypass flow control valve between the inflow pathway and the outflow pathway includes automatically modulating the bypass flow control valve.

[0130] In some aspects, the techniques described herein relate to a method, further including determining the calculated inflow pressure with a calibration curve.

[0131] In some aspects, the techniques described herein relate to a method, further including producing the calibration curve by charting the target inflow rate against a calculated inflow pressure.

[0132] In some aspects, the techniques described herein relate to a method, further including receiving an indication of a measured inter-renal pressure.

[0133] In some aspects, the techniques described herein relate to a method, further including calculating a bypass flow control valve rate based on the calculated inflow pressure, the measured inflow pressure, and the measured inter-renal pressure.

[0134] In some aspects, the techniques described herein relate to a method, further including comparing the bypass flow control valve rate to a target outflow rate, and wherein if the bypass flow control valve rate is greater than the target outflow rate, modifying fluid flow in the outflow pathway with an outflow motor control.

[0135] In some aspects, the techniques described herein relate to a method, further including comparing the measured inter-renal pressure to a predetermined threshold, and wherein if the measured inter-renal pressure is above the predetermined threshold, automatically adjusting the bypass flow control valve.

[0136] In some aspects, the techniques described herein relate to a method, further including setting a target inter-renal pressure, and if the measured inter-renal pressure is below the predetermined threshold, adjusting an outflow rate based on the target inter-renal pressure and the measured inter-renal pressure.

[0137] In some aspects, the techniques described herein relate to a method, further including adjusting an outflow rate to be equal to the bypass flow control valve rate.

[0138] In some aspects, the techniques described herein relate to a method, further including determining whether a clog is detected based on the bypass flow control valve rate.

[0139] In some aspects, the techniques described herein relate to a method, further including adjusting an outflow rate if a clog is detected.

[0140] In some aspects, the techniques described herein relate to a method, further including adjusting an outflow rate to be equal to the bypass flow control valve rate if a clog is not detected.

[0141] In some aspects, the techniques described herein relate to a urological fluid management system including: an inflow device actuatable for pumping a fluid through an inflow pathway with inflow pressure sensor; an outflow device actuatable for pumping a fluid through on outflow pathway with an outflow pressure sensor; and an automatic bypass flow valve fluidly connected between the inflow pathway and the outflow pathway, the bypass flow valve actuatable for altering pressure in the system.

[0142] In some aspects, the techniques described herein relate to a urological fluid management system, wherein the automatic bypass flow valve includes a motorized needle valve.

[0143] In some aspects, the techniques described herein relate to a urological fluid management system, wherein the automatic bypass flow valve includes a motorized pinch valve.

[0144] In some aspects, the techniques described herein relate to a urological fluid management system, further including a medical device fluidly connected to the irrigation device and the suction device.

[0145] In some aspects, the techniques described herein relate to a urological fluid management system, wherein the system includes an endoscope, the inflow pathway includes a first lumen.

[0146] In some aspects, the techniques described herein relate to a method of using a urological fluid management system having an inflow pathway, an outflow pathway, and a waste outlet, wherein the system is configured for regulating inter-renal pressure and maintaining a desired fluid outflow, the method including: receiving a measured inflow pressure of fluid flow through the inflow pathway; determining a calculated inflow pressure based on a target inflow rate of fluid through the inflow pathway; comparing the calculated inflow pressure with the measured inflow pressure; and if the measured inflow pressure exceeds the calculated inflow pressure, automatically adjusting a bypass flow control valve between the inflow pathway and the waste outlet.

[0147] In some aspects, the techniques described herein relate to a method, wherein automatically adjusting the bypass flow control valve between the inflow pathway and the waste outlet includes automatically opening or closing the bypass flow control valve.

[0148] In some aspects, the techniques described herein relate to a method, wherein automatically adjusting the bypass flow control valve between the inflow pathway and the waste outlet includes partially opening or closing the bypass flow control valve.

[0149] In some aspects, the techniques described herein relate to a method, wherein automatically adjusting the bypass flow control valve between the inflow pathway and the waste outlet includes automatically modulating the bypass flow control valve.

[0150] In some aspects, the techniques described herein relate to a method, further including determining the calculated inflow pressure with a calibration curve.

[0151] In some aspects, the techniques described herein relate to a method, further including producing the calibration curve by charting the target inflow rate against a calculated inflow pressure.

[0152] In some aspects, the techniques described herein relate to a method, further including calculating a bypass flow control valve rate based on the calculated inflow pressure and the measured inflow pressure.

[0153] In some aspects, the techniques described herein relate to a method, further including receiving an indication of a measured inter-renal pressure.

[0154] In some aspects, the techniques described herein relate to a method, further including setting a target inter-renal pressure.

[0155] In some aspects, the techniques described herein relate to a method, further including adjusting an outflow rate based on the measured inter-renal pressure and the target inter-renal pressure.

[0156] In some aspects, the techniques described herein relate to a method, wherein adjusting the outflow rate includes adjusting an outflow motor control on the outflow pathway.

[0157] In some aspects, the techniques described herein relate to an endoscope including: an inflow pathway configured to receive a fluid; an inflow device fluidly coupled to the inflow pathway and configured to pump fluid therethrough; a waste pathway for receiving the fluid; a bypass pathway extending between the waste pathway and the inflow pathway; and a bypass valve on the waste pathway, the bypass valve actuatable to shunt the fluid from the inflow pathway to the waste pathway.

[0158] In some aspects, the techniques described herein relate to an endoscope, further including: an outflow pathway configured to receive the fluid from the inflow pathway; an outflow device fluidly coupled to the outflow pathway and configured to pump the fluid to the waste pathway.

[0159] In some aspects, the techniques described herein relate to an endoscope, wherein the inflow pathway includes a first lumen.

[0160] In some aspects, the techniques described herein relate to an endoscope, wherein the outflow pathway includes a second lumen.

[0161] In some aspects, the techniques described herein relate to an endoscope, wherein the bypass valve includes a motorized needle valve.

[0162] In some aspects, the techniques described herein relate to an endoscope, wherein the bypass valve includes a motorized pinch valve.

[0163] In some aspects, the techniques described herein relate to a urological fluid management system including: an inflow device actuatable for pumping a fluid through an inflow pathway with an inflow pressure sensor; an outflow device actuatable for pumping a fluid through on outflow pathway with an outflow pressure sensor; a bypass flow valve fluidly connected between the inflow pathway and the outflow pathway, the bypass flow valve actuatable for altering pressure in the system; and a medical device fluidly connected to the inflow pathway and the outflow pathway.

[0164] In some aspects, the techniques described herein relate to a urological fluid management system, wherein the bypass flow valve includes a motorized needle valve.

[0165] In some aspects, the techniques described herein relate to a urological fluid management system, wherein the bypass flow valve includes a motorized pinch valve.

[0166] In some aspects, the techniques described herein relate to a method of using a urological fluid management system having an inflow pathway and an outflow pathway, wherein the system is configured for regulating inter-renal pressure and maintaining a desired fluid outflow, the method including: receiving a measured inflow pressure of fluid flow through the inflow pathway; determining a calculated inflow pressure based on a target inflow rate of fluid through the inflow pathway; comparing the calculated inflow pressure with the measured inflow pressure; and if the measured inflow pressure exceeds the calculated inflow pressure, automatically adjusting a bypass flow control valve between the inflow pathway and the outflow pathway.

[0167] In some aspects, the techniques described herein relate to a method, wherein automatically adjusting the bypass flow control valve between the inflow pathway and the outflow pathway includes automatically opening or closing the bypass flow control valve.

[0168] In some aspects, the techniques described herein relate to a method, wherein automatically adjusting the bypass flow control valve between the inflow pathway and the outflow pathway includes partially opening or closing the bypass flow control valve.

[0169] In some aspects, the techniques described herein relate to a method, wherein automatically adjusting the bypass flow control valve between the inflow pathway and the outflow pathway includes automatically modulating the bypass flow control valve.

[0170] In some aspects, the techniques described herein relate to a method, further including determining the calculated inflow pressure with a calibration curve.

[0171] In some aspects, the techniques described herein relate to a method, further including producing the calibration curve by charting the target inflow rate against a calculated inflow pressure.

[0172] In some aspects, the techniques described herein relate to a method, further including receiving an indication of a measured inter-renal pressure.

[0173] In some aspects, the techniques described herein relate to a method, further including calculating a bypass flow control valve rate based on the calculated inflow pressure, the measured inflow pressure, and the measured inter-renal pressure.

[0174] In some aspects, the techniques described herein relate to a method, further including comparing the bypass flow control valve rate to a target outflow rate, and whereinif the bypass flow control valve rate is greater than the target outflow rate, modifying fluid flow in the outflow pathway with an outflow motor control.

[0175] In some aspects, the techniques described herein relate to a method, further including comparing the measured inter-renal pressure to a predetermined threshold, and wherein if the measured inter-renal pressure is above the predetermined threshold, automatically adjusting the bypass flow control valve.

[0176] In some aspects, the techniques described herein relate to a method, further including setting a target inter-renal pressure, and if the measured inter-renal pressure is below the predetermined threshold, adjusting an outflow rate based on the target inter-renal pressure and the measured inter-renal pressure.

[0177] In some aspects, the techniques described herein relate to a method, further including adjusting an outflow rate to be equal to the bypass flow control valve rate.

[0178] In some aspects, the techniques described herein relate to a method, further including determining whether a clog is detected based on the bypass flow control valve rate.

[0179] In some aspects, the techniques described herein relate to a method, further including adjusting an outflow rate if a clog is detected.

[0180] In some aspects, the techniques described herein relate to a method, further including adjusting an outflow rate to be equal to the bypass flow control valve rate if a clog is not detected.

[0181] In some aspects, the techniques described herein relate to a urological fluid management system including: an inflow device actuatable for pumping a fluid through an inflow pathway with inflow pressure sensor; an outflow device actuatable for pumping a fluid through on outflow pathway with an outflow pressure sensor; and an automatic bypass flow valve fluidly connected between the inflow pathway and the outflow pathway, the bypass flow valve actuatable for altering pressure in the system.

[0182] In some aspects, the techniques described herein relate to a urological fluid management system, wherein the automatic bypass flow valve includes a motorized needle valve.

[0183] In some aspects, the techniques described herein relate to a urological fluid management system, wherein the automatic bypass flow valve includes a motorized pinch valve.

[0184] In some aspects, the techniques described herein relate to a urological fluid management system, further including a medical device fluidly connected to the irrigation device and the suction device.

[0185] In some aspects, the techniques described herein relate to a urological fluid management system, wherein the system includes an endoscope, the inflow pathway includes a first lumen.

[0186] In some aspects, the techniques described herein relate to a method of using a urological fluid management system having an inflow pathway, an outflow pathway, and a waste outlet, wherein the system is configured for regulating inter-renal pressure and maintaining a desired fluid outflow, the method including: receiving a measured inflow pressure of fluid flow through the inflow pathway; determining a calculated inflow pressure based on a target inflow rate of fluid through the inflow pathway; comparing the calculated inflow pressure with the measured inflow pressure; and if the measured inflow pressure exceeds the calculated inflow pressure, automatically adjusting a bypass flow control valve between the inflow pathway and the waste outlet.

[0187] In some aspects, the techniques described herein relate to a method, wherein automatically adjusting the bypass flow control valve between the inflow pathway and the waste outlet includes automatically opening or closing the bypass flow control valve.

[0188] In some aspects, the techniques described herein relate to a method, wherein automatically adjusting the bypass flow control valve between the inflow pathway and the waste outlet includes partially opening or closing the bypass flow control valve.

[0189] In some aspects, the techniques described herein relate to a method, wherein automatically adjusting the bypass flow control valve between the inflow pathway and the waste outlet includes automatically modulating the bypass flow control valve.

[0190] In some aspects, the techniques described herein relate to a method, further including determining the calculated inflow pressure with a calibration curve.

[0191] In some aspects, the techniques described herein relate to a method, further including producing the calibration curve by charting the target inflow rate against a calculated inflow pressure.

[0192] In some aspects, the techniques described herein relate to a method, further including calculating a bypass flow control valve rate based on the calculated inflow pressure and the measured inflow pressure.

[0193] In some aspects, the techniques described herein relate to a method, further including receiving an indication of a measured inter-renal pressure.

[0194] In some aspects, the techniques described herein relate to a method, further including setting a target inter-renal pressure.

[0195] In some aspects, the techniques described herein relate to a method, further including adjusting an outflow rate based on the measured inter-renal pressure and the target inter-renal pressure.

[0196] In some aspects, the techniques described herein relate to a method, wherein adjusting the outflow rate includes adjusting an outflow motor control on the outflow pathway.

[0197] In some aspects, the techniques described herein relate to an endoscope including: an inflow pathway configured to receive a fluid; an inflow device fluidly coupled to the inflow pathway and configured to pump fluid therethrough; a waste pathway for receiving the fluid; a bypass pathway extending between the waste pathway and the inflow pathway; and a bypass valve on the waste pathway, the bypass valve actuatable to shunt the fluid from the inflow pathway to the waste pathway.

[0198] In some aspects, the techniques described herein relate to an endoscope, further including: an outflow pathway configured to receive the fluid from the inflow pathway; an outflow device fluidly coupled to the outflow pathway and configured to pump the fluid to the waste pathway.

[0199] In some aspects, the techniques described herein relate to an endoscope, wherein the inflow pathway includes a first lumen.

[0200] In some aspects, the techniques described herein relate to an endoscope, wherein the outflow pathway includes a second lumen.

[0201] In some aspects, the techniques described herein relate to an endoscope, wherein the bypass valve includes a motorized needle valve.

[0202] In some aspects, the techniques described herein relate to an endoscope, wherein the bypass valve includes a motorized pinch valve.

[0203] In some aspects, the techniques described herein relate to a urological fluid management system including: an inflow device actuatable for pumping a fluid through an inflow pathway with an inflow pressure sensor; an outflow device actuatable for pumping a fluid through on outflow pathway with an outflow pressure sensor; a bypass flow valve fluidly connected between the inflow pathway and the outflow pathway, the bypass flowvalve actuatable for altering pressure in the system; and a medical device fluidly connected to the inflow pathway and the outflow pathway.

[0204] In some aspects, the techniques described herein relate to a urological fluid management system, wherein the bypass flow valve includes a motorized needle valve.

[0205] In some aspects, the techniques described herein relate to a urological fluid management system, wherein the bypass flow valve includes a motorized pinch valve.

[0206] Each of these non-limiting examples can stand on its own or can be combined in various permutations or combinations with one or more of the other examples.

[0207] 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 embodiments in which the invention can be practiced. These embodiments are also referred to herein as “examples.” Such examples can include elements in addition to those shown or described. However, the present inventors also contemplate examples in which only those elements shown or described are provided. Moreover, the present inventors also contemplate examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein.

[0208] In the event of inconsistent usages between this document and any documents so incorporated by reference, the usage in this document controls.

[0209] In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In this document, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, composition, formulation, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.

[0210] The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments can be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it 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 interpreted 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. Thus, the following claims are hereby incorporated into the Detailed Description as examples or embodiments, with each claim standing on its own as a separate embodiment, and it is contemplated that such embodiments can be combined with each other in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

Claims

CLAIMSWhat is claimed is:

1. A method of using a urological fluid management system having an inflow pathway and an outflow pathway, and a waste outlet, wherein the system is configured for regulating inter-renal pressure and maintaining a desired fluid outflow, the method comprising: receiving a measured inflow pressure of fluid flow through the inflow pathway; determining a calculated inflow pressure based on a target inflow rate of fluid through the inflow pathway; comparing the calculated inflow pressure with the measured inflow pressure; and if the measured inflow pressure exceeds the calculated inflow pressure, automatically adjusting one of: a bypass flow control valve between the inflow pathway and the outflow pathway and a bypass flow control valve between the inflow pathway and the waste outlet.

2. The method of claim 1, wherein automatically adjusting the bypass flow control valve between the inflow pathway and the outflow pathway comprises automatically opening or closing the bypass flow control valve.

3. The method of claim 1, wherein automatically adjusting the bypass flow control valve between the inflow pathway and the outflow pathway comprises partially opening or closing the bypass flow control valve.

4. The method of claim 1, wherein automatically adjusting the bypass flow control valve between the inflow pathway and the outflow pathway comprises automatically modulating the bypass flow control valve.

5. The method of claim 1, further comprising determining the calculated inflow pressure with a calibration curve, and producing the calibration curve by charting the target inflow rate against a calculated inflow pressure.

6. The method of claim 1, further comprising receiving an indication of a measured inter-renal pressure.

7. The method of claim 6, further comprising calculating a bypass flow control valve rate based on the calculated inflow pressure, the measured inflow pressure, and the measured inter-renal pressure, and comparing the bypass flow control valve rate to a target outflow rate, and wherein if the bypass flow control valve rate is greater than the target outflow rate, modifying fluid flow in the outflow pathway with an outflow motor control.

8. The method of claim 6, further comprising comparing the measured inter-renal pressure to a predetermined threshold, and wherein if the measured inter-renal pressure is above the predetermined threshold, automatically adjusting the bypass flow control valve, and setting a target inter-renal pressure, and if the measured inter-renal pressure is below the predetermined threshold, adjusting an outflow rate based on the target inter-renal pressure and the measured inter-renal pressure.

9. The method of claim 6, further comprising adjusting an outflow rate to be equal to the bypass flow control valve rate, and determining whether a clog is detected based on the bypass flow control valve rate.

10. The method of claim 9, further comprising adjusting an outflow rate if a clog is detected.

11. The method of claim 9, further comprising adjusting an outflow rate to be equal to the bypass flow control valve rate if a clog is not detected.

12. An endoscope comprising: an inflow pathway configured to receive a fluid; an inflow device fluidly coupled to the inflow pathway and configured to pump fluid therethrough; a waste pathway for receiving the fluid; a bypass pathway extending between the waste pathway and the inflow pathway; and a bypass valve on the waste pathway, the bypass valve actuatable to shunt the fluid from the inflow pathway to the waste pathway.

13. The endoscope of claim 12, further comprising: an outflow pathway configured to receive the fluid from the inflow pathway; an outflow device fluidly coupled to the outflow pathway and configured to pump the fluid to the waste pathway.

14. The endoscope of claim 12, wherein the inflow pathway comprises a first lumen.

15. The endoscope of claim 13, wherein the outflow pathway comprises a second lumen.

16. The endoscope of claim 12, wherein the bypass valve comprises a motorized needle valve.

17. The endoscope of claim 12, wherein the bypass valve comprises a motorized pinch valve.

18. A urological fluid management system comprising: an inflow device actuatable for pumping a fluid through an inflow pathway with an inflow pressure sensor; an outflow device actuatable for pumping a fluid through on outflow pathway with an outflow pressure sensor; a bypass flow valve fluidly connected between the inflow pathway and the outflow pathway, the bypass flow valve actuatable for altering pressure in the system; and a medical device fluidly connected to the inflow pathway and the outflow pathway.

19. The urological fluid management system of claim 18, wherein the bypass flow valve comprises a motorized needle valve.

20. The urological fluid management system of claim 18, wherein the bypass flow valve comprises a motorized pinch valve.

Citation Information

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