Smart valves

Abstract

A valve assembly for controlling fluid flow in a medical fluid handling system is disclosed. The valve assembly includes a valve body defining an inlet, an outlet, and a flow path therebetween, a sealing surface within the flow path, and a valve element movable between open and closed positions relative to the sealing surface. A solenoid is configured to actuate movement of the valve element. The valve assembly further includes at least one sensor arrangement configured to monitor an operating condition of the valve assembly, and an electronic control module mounted to the valve assembly and electrically coupled to the solenoid and the sensor arrangement. The electronic control module detects the operating condition during operation of the valve assembly and generates a valve status output indicative of the operating condition.

Description

Docket No. DIAL.025.WOSMART VALVESTECHNICAL FIELD

[0001] The present disclosure relates generally to fluid control systems in medical devices and, more specifically, to valves with advanced diagnostic and operational capabilities for enhancing performance, reliability, and patient safety in hemodialysis machines.BACKGROUND

[0002] Hemodialysis is a medical procedure that is used to achieve the extracorporeal removal of waste products including creatine, urea, and free water from a patient’s blood involving the diffusion of solutes across a semipermeable membrane. Failure to properly remove these waste products can result in renal failure.

[0003] During hemodialysis, the patient’s blood is removed by an arterial line, treated by a dialysis machine, and returned to the body by a venous line. The dialysis machine includes a dialyzer containing a large number of hollow fibers forming a semipermeable membrane through which the blood is transported. In addition, the dialysis machine utilizes a dialysate liquid, containing the proper amounts of electrolytes and other essential constituents (such as glucose), that is also pumped through the dialyzer.

[0004] Typically, dialysate is prepared by mixing water with appropriate proportions of an acid concentrate and a bicarbonate concentrate. Preferably, the acid and the bicarbonate concentrate are separated until the final mixing right before use in the dialyzer as the calcium and magnesium in the acid concentrate may precipitate out when in contact with the high bicarbonate level in the bicarbonate concentrate. The dialysate may also include appropriate levels of sodium, potassium, chloride, and glucose.

[0005] The dialysis process across the membrane is achieved by a combination of diffusion and convection. The diffusion entails the migration of molecules by random motion from regions of high concentration to regions of low7concentration. Meanwhile, convection entails the movement of solute typically in response to a difference in hydrostatic pressure. The fibers forming the semipermeable membrane separate the blood plasma from the dialysate and provide a large surface area for diffusion to take place which allows waste, including urea, potassium and phosphate, to permeate into the dialysate while preventing the transfer of larger molecules such as blood cells, polypeptides, and certain proteins into the dialysate.

[0006] Typically, the dialysate flows in the opposite direction to blood flow in the extracorporeal circuit. The countercurrent flow maintains the concentration gradient across theDocket No. DIAL.025.WOsemipermeable membrane so as to increase the efficiency of the dialysis. In some instances, hemodialysis may provide for fluid removal, also referred to as ultrafiltration. Ultrafiltration is commonly accomplished by lowering the hydrostatic pressure of the dialysate compartment of a dialyzer, thus allowing water containing dissolved solutes, including electrolytes and other permeable substances, to move across the membrane from the blood plasma to the dialysate. In rarer circumstances, fluid in the dialysate flow path portion of the dialyzer is higher than the blood flow portion, causing fluid to move from the dialysis flow path to the blood flow path. This is commonly referred to as reverse ultrafiltration. Since ultrafiltration and reverse ultrafiltration can increase the risks to a patient, ultrafiltration and reverse ultrafiltration are typically conducted while supervised by highly trained medical personnel.

[0007] Unfortunately, hemodialysis suffers from numerous drawbacks. An arteriovenous fistula is the most commonly recognized access point. To create a fistula, a doctor joins an artery and a vein together. Since this process bypasses the patient’s capillaries, blood flows rapidly. For each dialysis session, the fistula must be punctured with large needles to deliver blood into, and return blood from, the dialyzer. Typically, this procedure is done three times a week, for 3 - 4 hours at an out-patient facility. To a lesser extent, patients conduct hemodialysis at home. Home dialysis is typically done for two hours, six days a week. However, home hemodialysis requires more frequent treatment.

[0008] Home hemodialysis suffers from still additional disadvantages. Current home dialysis systems are big, complicated, intimidating, and difficult to operate. The equipment requires significant training. Home hemodialysis systems are currently too large to be portable, thereby preventing hemodialysis patients from traveling. Home hemodialysis systems are expensive and require a high initial monetary investment, particularly compared to in-center hemodialysis where patients are not required to pay for the machinery’. Present home hemodialysis systems do not adequately provide for the reuse of supplies, making home hemodialysis economically less feasible to medical suppliers. As a result of the above-mentioned disadvantages, very few motivated patients undertake the drudgery of home hemodialysis.

[0009] Furthermore, hemodialysis systems utilizing sorbent filters have not been widely accepted. Unfortunately, the sorbent filters are relatively expensive and can be spent quickly due to ion exchange that occurs as excess dialyzed ions - K+, Ca++, Mg++ and phosphate (PO4) are exchanged for benign or less toxic ions like Na+, H+, bicarbonate (HCO3-) and acetate.

[0010] Hemodialysis machines rely on valves to precisely control the flow of blood and dialysate during treatment. These valves play a critical role in ensuring accurate fluidDocket No. DIAL.025.WOmovement and maintaining the safety and efficacy of the procedure. Traditional solenoid valves used in hemodialysis machines are “dumb” valves, operating in a simple on / off manner with no capability to monitor or diagnose issues during operation.

[0011] The limitations of traditional valves create challenges in detecting and addressing problems such as internal leaks, atmospheric leaks, improper valve positioning, or electrical malfunctions. When a valve fails, diagnosing the root cause typically requires skilled technicians and specialized tools, resulting in increased downtime, costs, and resource allocation. Moreover, traditional valves provide no real-time feedback or performance monitoring, potentially leading to undetected issues that could compromise treatment and patient safety.

[0012] Accordingly, there is a need for advanced valves with integrated diagnostic and operational capabilities. These “smart valves” would not only enhance fluid control but also provide real-time monitoring and feedback, enabling immediate detection of leaks, electrical issues, and mechanical failures. Such innovations would significantly improve reliability, simplify maintenance, and enhance patient comfort and safety during hemodialysis procedures.SUMMARY

[0013] The present disclosure relates to systems, devices, and methods for enhancing fluid control and diagnostic capability in medical fluid handling systems. In some embodiments, the disclosure provides valve architectures with integrated sensing, control, and diagnostic features that enable real-time monitoring of valve operating conditions, improved reliability, simplified maintenance, and enhanced patient safety.

[0014] Disclosed are example embodiments of a valve assembly for controlling fluid flow in a medical fluid handling system. The valve assembly includes a valve body defining an inlet, an outlet, and a flow path therebetween, a sealing surface positioned within the flow' path, and an actuated valve element movable relative to the sealing surface between open and closed positions. A solenoid drives movement of the actuated valve element, and at least one sensor arrangement monitors an operating condition of the valve assembly. An electronic control module mounted to the valve assembly is electrically coupled to the solenoid and the sensor arrangement and is configured to detect the operating condition during operation of the valve assembly and generate a valve status output indicative of valve performance or integrity.

[0015] Disclosed are further example embodiments of a hemodialysis system that incorporates valve integrity monitoring. The hemodialysis system includes a dialysate flow circuit and a valve assembly disposed within the dialysate flow circuit. The valve assembly includes a valveDocket No. DIAL.025.WObody defining a flow path for dialysate, a balancing chamber separated from the flow path by a membrane, and an electronic control module configured to generate a valve status output indicative of membrane integrity. A system controller is communicatively coupled to the electronic control module and is configured to receive the valve status output and respond to detected leaks or abnormal operating conditions to enhance patient safety during dialysis treatment.

[0016] Disclosed are further example embodiments of a method of operating a valve in a medical fluid handling system. The method includes actuating a solenoid to move a valve element relative to a sealing surface, monitoring at least one operating condition of the valve using a sensor arrangement mounted to the valve, and processing sensor data using an electronic control module mounted to the valve. The method further includes generating a valve status output indicative of the operating condition, which may be used to identify leakage, abnormal valve operation, or other conditions affecting valve performance.BRIEF DESCRIPTION OF THE DRAWINGS

[0017] The foregoing summary, as well as the following detailed description, is better understood when read in conjunction with the accompanying drawings. The accompanying drawings, which are incorporated herein and form part of the specification, illustrate a plurality7of embodiments and, together with the description, further serve to explain the principles involved and to enable a person skilled in the relevant art(s) to make and use the disclosed technologies.

[0018] FIGS. 1A-1B are schematic diagrams illustrating a smart valve with integrated leak detection electrodes positioned upstream and downstream of the sealing surface, in accordance with the systems and methods described herein.

[0019] FIG. 2 is a diagram illustrating the leak detection system in accordance with the systems and methods described herein.

[0020] FIG. 3 is a diagram illustrating the placement of an elastomeric pad on the valve armature to provide soft-close functionality, reducing noise during operation, in accordance with the systems and methods described herein.

[0021] FIG. 4 is a diagram showing the compact circuit board design mounted on the smart valve, incorporating components such as a microprocessor, current monitoring chip, Hall effect sensor, LED indicator, and strike and hold chip in accordance with the systems and methods described herein.Docket No. DIAL.025.WO

[0022] The figures and the following description describe certain embodiments by way of illustration only. One skilled in the art will readily recognize from the following description that alternative embodiments of the structures and methods illustrated herein may be employed without departing from the principles described herein. Reference wall now be made in detail to several embodiments, examples of which are illustrated in the accompanying figures. It is noted that wherever practicable similar or like reference numbers may be used in the figures to indicate similar or like functionality.DETAILED DESCRIPTION

[0023] The detailed description set forth below in connection with the appended drawings is intended as a description of configurations and is not intended to represent the only configurations in which the concepts described herein may be practiced. The detailed description includes specific details for the purpose of providing a thorough understanding of various concepts. How ever, it will be apparent to those skilled in the art that these concepts may be practiced without these specific details. In some instances, well-known structures and components are shown in block diagram form in order to avoid obscuring such concepts.

[0024] Objective of some embodiments:

[0025] In hemodialysis, valves may play an important role in controlling fluid movement within the machine. Traditionally, solenoid valves used in hemodialysis machines are basic, "dumb” valves, operating in a simple on / off manner.

[0026] In some embodiments, the systems and methods described herein introduce the concept of a “smart valve,” which represents an innovative approach to enhancing valve functionality. Additionally, outlined below is a novel method for creating smart valves.

[0027] FIGS. 1 A-1B are schematic diagrams illustrating a smart valve 100 with integrated leak detection electrodes (e.g., Electrode A 102 and Electrode B 104) positioned upstream and downstream of the sealing surface (e.g., intact seal 106), in accordance with the systems and methods described herein.

[0028] In some embodiments, the smart valve 100 may introduce an enhanced level of functionality and diagnostic capability compared to traditional on / off solenoid valves. By incorporating one or more innovative features, either individually or in combination, the valve may operate as a smart valve 100 capable of monitoring leak conditions through a sealing path. In certain embodiments, the valve 100 includes electrodes positioned upstream and downstream of a sealing surface. A low-voltage alternating current signal 108 may be applied to one of the electrodes (e.g., Electrode A 102). When the non-conductive seal 106 is intactDocket No. DIAL.025.WO(FIG. 1 A), the seal may prevent the electrical signal 108 from reaching the other electrode (e.g., Electrode B 104). However, if the non-conductive seal 106 includes a tear, rip, or other defect (FIG. IB) that permits fluid to pass when the valve is intended to be in a closed state, the electrical signal 108 may propagate through the leak path and be detected 110 at the downstream electrode (e.g., Electrode B 104). Information associated with the detected leak condition may be processed by an onboard microprocessor mounted to the valve. Based on the processed information, the smart valve 100 may activate a visual indicator, such as a lightemitting diode, and or transmit the information to an external system or controller for further analysis, logging, or mitigation action.

[0029] In some embodiments, the smart valve 100 may be configured to monitor leakage to atmosphere. To detect such leaks, the valve 100 may include conductive wires, conductive elastomer, or combinations thereof positioned around a perimeter of the valve body and located outside a primary O-ring seal. A breach in sealing integrity that allows fluid to escape to atmosphere may be detected by the conductive elements and identified as a leak condition. Information associated with the detected leak condition may be processed by an onboard microprocessor mounted to the valve. Based on the processed information, the smart valve 100 may activate a visual indicator, such as a light-emitting diode, and or transmit the information to an external system or controller for further analysis, logging, or mitigation action.

[0030] FIG. 2 is an isometric and bottom view of an example smart valve assembly 100 illustrating external housing features, fluid interface seals, and an example leak detection arrangement. In the illustrated embodiment, inlet O-ring 202 and outlet O-ring 204 may be positioned on a bottom surface 206 of the valve housing to form fluid seals with corresponding fluid connections. A wetness detection circuit 208 may be positioned on or adjacent to the bottom surface of the valve housing such that fluid leaking past the inlet O-ring 202 or outlet O-ring 204 to atmosphere may contact the wetness detection circuit 208 and create a conductive path between conductive elements, thereby indicating a leak condition. The leak detection arrangement illustrated in FIG. 2 is provided as one example sensing mechanism, and other monitoring, control, and diagnostic features described herein may be implemented independently of, or in addition to, the atmospheric leak detection configuration show n in FIG.2. In further embodiments of the smart valve, additional sensing, control, and diagnostic functionality may be integrated into the valve assembly, independently or in combination with the leak detection arrangement illustrated in FIG. 2. Other configurations and sensing arrangements may be used without departing from the scope of the disclosure.Docket No. DIAL.025.WO

[0031] In some embodiments, the smart valve may be configured to monitor electrical current supplied to the solenoid during operation. The valve may integrate a current monitoring chip that measures cunent usage associated with valve actuation. When the measured current remains within a specified operating range, the valve may be identified as operating normally. When the measured current falls outside the specified range, the condition may be identified as an abnormal or malfunctioning state. Information associated with the monitored current may be provided to an onboard microprocessor mounted to the valve, which may activate a visual indicator, such as a light-emitting diode, or transmit the information to an external system or controller for further analysis or corrective action.

[0032] In some embodiments, the Smart Valve may include a Hall effect sensor for monitoring valve positioning. If a valve armature does not achieve full intended travel during operation, the condition may be detected using a Hall effect sensor positioned proximate to the armature. The Hall effect sensor may monitor a magnetic field generated by the solenoid in real time and use changes in the magnetic field to determine a position of the armature. This monitoring may¬ be used to verify that the armature reaches a fully open position or a fully closed position. When incomplete travel or other positional deviation is detected, the condition may be communicated to an onboard microprocessor mounted to the valve, which may activate a visual indicator or transmit the information externally for further action.

[0033] In some embodiments, the Smart Valve may incorporate integrated valve usage and replacement tracking. Using a built-in microprocessor, the valve may monitor and store usage information including a number of valve actuations, a cumulative duration during which the valve remains fully energized, and a total duration during which the valve operates using pulse width modulation. In addition, the valve may store identifying information such as a manufacturing date and a lot number. The stored usage information may be used to indicate when the valve approaches or exceeds a predetermined service life, which may result in activation of a visual indicator or transmission of the information to a user interface. The usage monitoring functionality may also detect valve replacement events and record information associated with replacement frequency or timing. The collected data may be transmitted to external systems for analysis, maintenance planning, or lifecycle tracking.

[0034] In some embodiments, the smart valve may include an integrated strike-and-hold valve control circuit. A control chip may be integrated into the valve to provide strike-and-hold functionality, allowing the valve to be actuated using a simple constant-voltage signal, such as a twenty-four volt signal, while internal circuitry manages an initial strike phase and a subsequent hold phase. By integrating strike-and-hold control within the valve, complexityDocket No. DIAL.025.WOassociated with implementing strike-and-hold logic at a main system control board may be reduced, thereby simplifying system design and reducing control board workload.

[0035] In some embodiments, the smart valve may include one or more light-emitting diode indicators for providing visual status information. The indicator may be a multi-color lightemitting diode or one or more individually addressable light-emitting diodes configured to provide different visual indications corresponding to valve operating conditions. For example, the absence of illumination may indicate that the valve is not energized and remains closed, while illumination in different colors may indicate conditions such as normal operation, detected leakage, abnormal current levels, or incomplete solenoid actuation. The specific colors and associated meanings may be selected to provide intuitive status feedback to a user or service technician.

[0036] In some embodiments, the smart valve may be configured to provide soft-close operation. Traditional solenoid valves may produce an audible noise when energized due to an armature coming to an abrupt stop. To reduce such noise, the smart valve may include an elastomeric element positioned to damp movement of the armature as it reaches an end of travel. The elastomeric element may absorb impact energy and reduce abrupt stopping forces, thereby significantly reducing audible noise and resulting in quieter valve operation.

[0037] FIG. 3 is a diagram illustrating the placement of an elastomeric pad 302 on an armature of the valve 100 to provide soft-close functionality. The elastomeric pad 302 is positioned to damp movement of the armature as it reaches an end of travel, thereby reducing impact forces and audible noise during valve operation.

[0038] In some embodiments, the valve assembly includes one or more captive fasteners, such as captive screws, configured to remain mechanically retained within the valve assembly during disassembly and reassembly. The use of captive screws reduces the likelihood of fastener loss during manufacturing, installation, servicing, or repair operations. By preventing loose fasteners from becoming detached, the valve assembly reduces the risk of foreign object debris (FOD) within the medical fluid handling system. Captive screws further improve maintenance efficiency by ensuring that fasteners remain readily accessible and correctly positioned, thereby simplifying assembly and repair procedures and reducing associated labor time and replacement costs.

[0039] By incorporating one or more of the features described herein, including integrated sensing, control, and mechanical retention features, the valve assembly may significantly enhance fluid control, diagnostic capability, maintenance efficiency, and patient safety.Docket No. DIAL.025.WOCollectively, these features enable a more advanced valve architecture compared to conventional solenoid valves used in medical fluid handling systems.

[0040] Conventional solenoid valves used in hemodialysis and similar medical applications are typically limited to basic on / off actuation and provide little or no information regarding valve condition or performance. When such a valve fails or operates improperly, determining the underlying cause — such as an internal leak, an external leak to atmosphere, electrical current anomalies, or improper armature movement — may be difficult without manual inspection. Diagnosis often requires intervention by a skilled field service technician, increasing system downtime, service costs, and resource utilization.

[0041] In accordance with example embodiments disclosed herein, the valve assembly provides functionality beyond simple actuation, enabling operation as a “smart7' valve capable of self-monitoring and diagnostic reporting. In some embodiments, the valve assembly is configured to detect and distinguish among multiple operating conditions, including internal leakage, leakage to atmosphere, electrical current abnormalities, and armature position-related issues. Diagnostic information generated by the valve assembly may be used for reliability tracking, predictive maintenance, and fault isolation.

[0042] In some embodiments, the valve assembly further improves patient comfort by operating with reduced acoustic noise compared to conventional solenoid valves. Additionally, by integrating control functionality at the valve level, such as strike-and-hold current control for the solenoid, the valve assembly may simplify upstream control electronics. Offloading such functions from a central controller reduces system complexity and enables more scalable and robust medical device architectures.

[0043] FIG. 4 is a diagram illustrating the compact circuit board design mounted on the smart valve, incorporating components such as a microprocessor, current monitoring chip. Hall effect sensor, LED indicator, and strike and hold chip in accordance with the systems and methods described herein.

[0044] Construction and Operation Description:

[0045] Monitor Leak Detection Through the Sealing Path

[0046] In some embodiments, the valve assembly includes captive screws as described above. The captive screws remain attached to the associated components during assembly, disassembly, or servicing, thereby reducing the likelihood that fasteners are lost or misplaced. By keeping the screws secured and readily accessible, the use of captive screws may simplify assembly and repair procedures and improve overall service efficiency. In addition, retainingDocket No. DIAL.025.WOthe screws with the valve assembly may reduce replacement costs and help prevent the introduction of foreign object debris within the medical fluid handling system.

[0047] In some embodiments, leakage to atmosphere may be monitored by providing conductive wires, conductive elastomer, or combinations thereof around a perimeter of the valve body. The conductive elements may be positioned external to a primary seal and configured to detect leakage conditions when fluid escapes from the valve to atmosphere.

[0048] In some embodiments, electrical current supplied to the valve may be monitored using a current monitoring chip. A low-cost, commercially available current monitoring chip may be selected and mounted on a circuit board, such as the circuit board shown in FIG. 4, to measure current usage associated with valve operation.

[0049] In some embodiments, valve positioning may be monitored using a Hall effect sensor. A low-cost, commercially available Hall effect sensor may be selected and mounted on the circuit board shown in FIG. 4. The Hall effect sensor may be positioned to detect a magnetic field generated by a solenoid and used to determine a position of a valve armature during operation.

[0050] In some embodiments, strike-and-hold valve control functionality may be integrated into the valve assembly. A low-cost, commercially available strike-and-hold control chip may be selected and mounted on the circuit board shown in FIG. 4 to manage an initial strike phase and a subsequent hold phase during valve actuation.

[0051] In some embodiments, the valve assembly may include one or more light-emitting diode indicators. A multi-color light-emitting diode or one or more individually addressable light-emitting diodes may be attached to the circuit board and programmed to display specific colors corresponding to valve status conditions. In addition, a single light-emitting diode may be programmed to blink in predetermined patterns, where a number or sequence of blinks corresponds to different error codes or operating states.

[0052] In some embodiments, the valve assembly may be configured to provide soft-close operation. An elastomeric pad may be added at a stop point of a valve armature to damp impact as the armature reaches an end of travel. The elastomeric pad may reduce impact forces and associated noise, resulting in quieter valve operation.

[0053] FIG. 4 illustrates an example location at which a compact circuit board may be mounted to the valve assembly to house electronic components. Mounting the circuit board at this location enables the valve assembly to incorporate onboard electronics and operate as a smart valve with enhanced monitoring and control functionality.Docket No. DIAL.025.WO

[0054] In the embodiment illustrated in FIG. 3 and FIG. 4, the circuit board mounted to the smart valve provides defined mounting locations for multiple electronic components. The circuit board includes a microprocessor mounted thereon to execute valve control and diagnostic logic, one or more current monitoring components mounted to sense electrical current supplied to the solenoid, and a Hall effect sensor mounted in a position selected to detect magnetic field changes associated with movement of a valve armature. The circuit board further supports one or more light-emitting diode indicators mounted to provide visual status information, as well as a strike-and-hold control component mounted to manage solenoid drive during valve actuation. Mounting these components on a single compact circuit board enables integration of sensing, control, indication, and drive functionality' directly on the valve assembly.

[0055] In some embodiments, the smart valve may provide improved functionality' and perceived novelty by enabling real-time electrical monitoring of multiple valve operating conditions. By electrically’ monitoring a seal or balancing chamber associated with the valve, a leak condition may be detected immediately, allowing risk mitigation actions to be initiated as soon as the leak is identified. Similarly, by electrically monitoring for leakage to atmosphere, abnormal conditions may be detected in real time and addressed without delay. Monitoring electrical current supplied to the valve may allow abnormal operating conditions to be identified as soon as deviations occur, enabling immediate mitigation. In addition, monitoring armature position may allow incomplete or abnormal valve actuation to be detected promptly, further improving operational reliability.

[0056] FIG. 5 is a flowchart 500 illustrating an example method of operating a valve in a medical fluid handling system in accordance with the systems and methods described herein. The method includes, at step 502. actuating a solenoid to move a valve element relative to a sealing surface; at step 504, monitoring one or more operating conditions of the valve using one or more sensor arrangements mounted to the valve; at step 506, processing sensor data using an electronic control module mounted to the valve; and at step 508, generating a valve status output indicative of the operating condition. In some embodiments, the method further includes, at step 510, controlling energization of the solenoid using a strike-and-hold control circuit integrated into the valve, and, at step 512, reducing valve actuation noise by damping movement of the valve element using an elastomeric element.

[0057] At step 502, the method includes actuating a solenoid to move a valve element relative to a sealing surface. Actuating the solenoid may include applying an electrical drive signal to energize the solenoid and generate a magnetic field that causes movement of an armatureDocket No. DIAL.025.WOcoupled to the valve element. In some embodiments, actuating the solenoid includes transitioning the valve element between an open position and a closed position, and may further include controlling the timing, magnitude, or duration of the applied drive signal to achieve a desired actuation profile.

[0058] At step 504, the method includes monitoring at least one operating condition of the valve using a sensor arrangement mounted to the valve. Monitoring the operating condition may include detecting fluid leakage across a sealing surface using electrodes positioned upstream and downstream of the sealing surface, such that electrical conductivity across the sealing surface indicates internal leakage. Monitoring the operating condition may also include detecting fluid leakage to atmosphere using a conductive element positioned external to a primary seal, where contact between leaked fluid and the conductive element produces a detectable electrical response.

[0059] In some embodiments, monitoring the operating condition further includes monitoring electrical current supplied to the solenoid, which may indicate normal operation, increased mechanical resistance, incomplete actuation, or electrical faults. The monitored operating conditions may be sensed continuously, periodically, or in response to valve actuation events.

[0060] At step 506, the method includes processing sensor data using an electronic control module mounted to the valve. Processing the sensor data may include filtering, digitizing, scaling, or otherwise conditioning sensor signals received from one or more sensor arrangements. The electronic control module may analyze the processed sensor data to determine whether the valve is operating within expected parameters, and may compare one or more sensor measurements to predetermined thresholds or expected profiles.

[0061] In some embodiments, processing the sensor data includes correlating electrical current measurements with valve position information, identifying leakage conditions based on conductivity measurements, and determining whether a detected condition represents a normal operating state or an abnormal condition requiring attention.

[0062] At step 508, the method includes generating a valve status output indicative of the operating condition of the valve. Generating the valve status output may include activating a visual indicator mounted to the valve, such as a light-emitting diode configured to display different colors or blink patterns corresponding to different operating states. In some embodiments, generating the valve status output includes transmitting operating condition information to an external controller, user interface, or monitoring system for further analysis or action.Docket No. DIAL.025.WO

[0063] In some embodiments, at step 510, the method further includes controlling energization of the solenoid using a strike-and-hold control circuit integrated into the valve. Controlling energization may include applying a higher initial drive current during a strike phase to initiate valve movement, followed by a lower holding current to maintain the valve element in position while reducing power consumption and heat generation.

[0064] In some embodiments, at step 512, the method further includes reducing valve actuation noise by damping movement of the valve element using an elastomeric element. Damping movement may include absorbing kinetic energy of the valve element or armature as it approaches an end of travel, thereby reducing impact forces and associated audible noise during valve operation.

[0065] The preceding disclosure provides illustration and description but is not intended to be exhaustive or to limit the implementations to the precise form disclosed. Modifications may be made in light of the above disclosure or may be acquired from practice of the implementations. As used herein, the term “component” is intended to be broadly construed. Although particular combinations of features are recited in the claims and / or disclosed in the specification, these combinations are not intended to limit the disclosure of various implementations. In fact, many of these features may be combined in ways not specifically recited in the claims and / or disclosed in the specification.

[0066] Although each dependent claim listed below may directly depend on only one claim, the disclosure of various implementations includes each dependent claim in combination with every other claim in the claim set. No element, act, or instruction used herein should be construed as critical or essential unless explicitly described as such. Also, as used herein, the articles “a” and “an” are intended to include one or more items and may be used interchangeably with “one or more.” Further, as used herein, the article “the” is intended to include one or more items referenced in connection with the article “the” and may be used interchangeably with “the one or more.” Furthermore, as used herein, the term “set” is intended to include one or more items (e.g., related items, unrelated items, a combination of related and unrelated items, and / or the like) and may be used interchangeably with “one or more.” The phrase “only one” or similar language is used where only one item is intended. Also, as used herein, the terms “has,” “have,” “having,” or the like are intended to be open-ended terms. Further, the phrase “based on” is intended to mean “based, at least in part, on” unless explicitly stated otherwise. Also, as used herein, the term “or” is intended to be inclusive when used in a series and may be used interchangeably with “and / or,” unless explicitly stated otherwise (e.g., if used in combination with “either” or “only one of’).Docket No. DIAL.025.WO

[0067] One or more elements or aspects or steps, or any portion(s) thereof, from one or more of any of the systems and methods described herein, may be combined with one or more elements or aspects or steps, or any portion(s) thereof, from one or more of any of the other systems and methods described herein and combinations thereof, to form one or more additional implementations and / or claims of the present disclosure.

[0068] One or more components, steps, features, and / or functions illustrated in the figures may be rearranged and / or combined into a single component, feature, or function. Additional elements, components, steps, and / or functions may also be added without departing from the disclosure. The apparatus, devices, and / or components illustrated in the Figures may be configured to perform one or more of the methods, features, or steps described in the Figures.

[0069] Reference in the specification to “one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the invention. The appearances of the phrase “in one embodiment” in various places in the specification do not necessarily refer to the same embodiment.

[0070] The figures and the description describe certain embodiments by way of illustration only. One skilled in the art will readily recognize from the following description that alternative embodiments of the structures and methods illustrated herein may be employed without departing from the principles described herein. Reference will now be made in detail to several embodiments, examples of which are illustrated in the accompanying figures. It is noted that wherever practicable similar or like reference numbers may be used in the figures to indicate similar or like functionality7.

[0071] The foregoing description of the embodiments of the present invention has been presented for the purposes of illustration and description. It is not intended to be exhaustive or to limit the present invention to the precise form disclosed. Many modifications and variations are possible in light of the above teaching. It is intended that the scope of the present invention be limited not by this detailed description, but rather by the claims of this Application. As will be understood by those familiar with the art, the present invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. Likewise, the naming and division of the mechanisms, components, and features are not mandatory or significant, and the mechanisms that implement the present invention or its features may have different names, divisions and / or formats.

[0072] The previous description is provided to enable any person skilled in the art to practice the various aspects described herein. Various modifications to these aspects will be readilyDocket No. DIAL.025.WOapparent to those skilled in the art, and the generic principles defined herein may be applied to other aspects. Thus, the claims are not intended to be limited to the aspects shown herein, but is to be accorded the full scope consistent with the language claims, wherein reference to an element in the singular is not intended to mean “one and only one” unless specifically so stated, but rather “one or more.” The word “exemplary” is used herein to mean “serving as an example, instance, or illustration.” Any aspect described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other aspects. Unless specifically stated otherwise, the term “some” refers to one or more. Combinations such as “at least one of A, B, or C,” “one or more of A, B, or C,” “at least one of A, B, and C,” “one or more of A, B, and C,” and “A, B, C, or any combination thereof’ include any combination of A, B, and / or C, and may include multiples of A, multiples of B. or multiples of C. Specifically, combinations such as "at least one of A, B, or C,” “one or more of A, B, or C,” “at least one of A, B, and C,” “one or more of A, B, and C,” and “A, B, C, or any combination thereof’ may be A only, B only, C only, A and B, A and C, B and C, or A and B and C, where any such combinations may contain one or more member or members of A, B. or C. All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims. The words “module,” “mechanism,” “element,” “device.” and the like may not be a substitute for the word “means.” As such, no claim element is to be construed as a means plus function unless the element is expressly recited using the phrase “means for.”

Claims

Docket No. DIAL.025.WOCLAIMS1. A valve assembly for controlling fluid flow in a medical fluid handling system, comprising:a valve body defining an inlet, an outlet, and a flow path therebetween;a sealing surface positioned within the flow path;an actuated valve element movable relative to the sealing surface between an open position and a closed position;a solenoid configured to drive movement of the actuated valve element;at least one sensor arrangement configured to monitor an operating condition of the valve assembly; andan electronic control module mounted to the valve assembly and electrically coupled to the solenoid and the at least one sensor arrangement,wherein the electronic control module is configured to detect the operating condition during operation of the valve assembly and generate a valve status output.

2. The valve assembly of claim 1, wherein the at least one sensor arrangement comprises a first electrode positioned upstream of the sealing surface and a second electrode positioned dow nstream of the sealing surface.

3. The valve assembly of claim 2, wherein the electronic control module is configured to apply an electrical signal to the first electrode and detect a sealing-path leak based on detection of the electrical signal at the second electrode when the valve assembly is in the closed position.

4. The valve assembly of claim 1, wherein the at least one sensor arrangement comprises a conductive element positioned external to a primary fluid seal of the valve body and configured to detect leakage to atmosphere.

5. The valve assembly of claim 4, wherein the conductive element comprises at least one of conductive wires or conductive elastomer disposed around a perimeter of the valve body.Docket No. DIAL.025.WO6. The valve assembly of claim 1, wherein the electronic control module includes a current monitoring circuit configured to measure electrical current supplied to the solenoid.

7. The valve assembly of claim 6, wherein the electronic control module is configured to identify an abnormal operating condition based on the measured electrical current being outside a predetermined range.

8. The valve assembly of claim 1, further comprising a magnetic field sensor positioned relative to the solenoid and configured to detect a position of the actuated valve element.

9. The valve assembly of claim 8, wherein the magnetic field sensor comprises a Hall effect sensor configured to detect incomplete travel of the actuated valve element.

10. A hemodialysis system, comprising:a dialysate flow circuit;a valve assembly disposed within the dialysate flow circuit, the valve assembly including: a valve body defining a flow path for dialysate;a membrane separating a balancing chamber from the flow path; andan electronic control module configured to generate a valve status output indicative of membrane integrity'; anda system controller communicatively coupled to the electronic control module and configured to receive the valve status output.

11. The hemodialysis system of claim 10, wherein the system controller is configured to initiate a mitigation action in response to the valve status output indicating a leak or abnormal operating condition.

12. The hemodialysis system of claim 10, wherein the electronic control module is configured to store usage data associated with the valve assembly.Docket No. DIAL.025.WO13. The hemodialysis system of claim 12, wherein the usage data includes at least one of a number of valve actuations, cumulative energized time, pulse-width-modulated operating time, manufacturing date, or lot identification.

14. The hemodialysis sy stem of claim 10, wherein the valve assembly includes a visual indicator mounted to the valve body and controlled by the electronic control module to indicate valve status.

15. A method of operating a valve in a medical fluid handling system, comprising:actuating a solenoid to move a valve element relative to a sealing surface; monitoring at least one operating condition of the valve using a sensor arrangement mounted to the valve;processing sensor data using an electronic control module mounted to the valve; and generating a valve status output indicative of the operating condition.

16. The method of claim 15, wherein monitoring the at least one operating condition comprises detecting fluid leakage across the sealing surface using electrodes positioned upstream and downstream of the sealing surface.

17. The method of claim 15, wherein monitoring the at least one operating condition comprises detecting fluid leakage to atmosphere using a conductive element positioned external to a primary seal.

18. The method of claim 15, wherein monitoring the at least one operating condition comprises monitoring electrical current supplied to the solenoid.

19. The method of claim 15, further comprising controlling energization of the solenoid using a strike-and-hold control circuit integrated into the valve.

20. The method of claim 15, further comprising reducing valve actuation noise by damping movement of the valve element using an elastomeric element.

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