System and method for an environment-controlled potentiostat device

Abstract

A system and method for an environment-controlled potentiostat device may include a housing defining a reaction region, an electrochemical sensor positioned within the reaction region, and an environmental control system including a thermal control system and a humidity control system positioned to monitor and affect the reaction region. A controller may be connected to the electrochemical sensor and the environmental control system to manage device operation. The environmental control system maybe used to control of temperature and humidity conditions within the reaction region, enhancing the reliability and accuracy of electrochemical sensing while enabling portable and field-based operation.

Description

ESEN-M03-PCTSYSTEM AND METHOD FORAN ENVIRONMENT-CONTROLLED POTENTIOSTAT DEVICECROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This Application claims the benefit of U.S. Provisional Application No. 63 / 688,608, filed on 29-AUG-2024, titled “SYSTEM AND METHOD FORAN ENVIRONMENT-CONTROLLED POTENTIOSTAT DEVICE”, which is incorporated in its entirety by this reference.FEDERALLY SPONSORED RESEARCH AND DEVELOPMENT

[0002] This invention was made with Government support under Grant No. FA864924P0993 awarded by AFWERX / U.S. Air Force. The Government has certain rights in this invention.TECHNICAL FIELD

[0003] This invention relates generally to the field of electrochemical sensing devices and more specifically to a new and useful system and method for an environment- controlled potentiostat device.BACKGROUND OF THE INVENTION

[0004] Potentiostat devices are essential tools in electrochemical analysis, widely used for applications in chemistry, biology, and environmental science. Traditionally, these devices are designed for use in controlled laboratory environments, requiring stable power sources, precise temperature control, and a contaminant-free setting. As a result, their functionality is limited to lab-based settings, restricting their applicability in fieldwork or other uncontrolled environments.ESEN-M03-PCT

[0005] Moreover, current potentiostat devices often require complex operation and a high degree of user expertise, which limits their use to skilled technicians and specialized labs. Environmental control systems for electrochemical analysis typically rely on large laboratory chambers or controlled room environments, which are not suitable for mobile or field-based applications. The combination of limited portability, environmental sensitivity, and operational complexity poses significant challenges for conducting on-site electrochemical analysis in varying ambient conditions such as extreme temperatures or humidity levels.

[0006] Thus, there is a need in the electrochemical sensing device field to create a new and useful system and method for an environment-controlled potentiostat device. This invention provides such a new and useful system and method.BRIEF DESCRIPTION OF DRAWINGS

[0007] FIGURE 1 is a schematic representation of a system variation.

[0008] FIGURE 2 is a schematic representation of one working electrode of an electrochemical sensor variation.

[0009] FIGURE 3 is a schematic representation of a three-electrode electrochemical sensor.

[0010] FIGURE 4 is a flowchart representation of a method variation.

[0011] FIGURE 5 is a flowchart representation of another method variation.

[0012] FIGURE 6 is an exemplary system architecture that may be used in implementing the system and / or method.DETAILED DESCRIPTION OF THE EMBODIMENTS

[0013] The following description of the embodiments of the invention is not intended to limit the invention to these embodiments but rather to enable a person skilled in the art to make and use this invention.1. OverviewESEN-M03-PCT

[0014] The systems and methods described herein function to enable a potentiostat device that dynamically controls the environmental conditions within a reaction zone for more accurately and reliably performing electrochemical sensing. The systems and methods may control the environmental conditions like temperature and humidity to target and maintain desired conditions.

[0015] The systems and methods can integrate environmental monitoring and control capabilities directly within a potentiostat device architecture, enabling precise environmental management without reliance on external laboratory infrastructure. This integrated approach may allow the systems and methods to maintain controlled environmental conditions within a localized reaction region while enabling mobile and field-based operation. An environmental control system of the systems and methods may include both sensing and actuation / augmentation capabilities that work in coordination with the controller to actively manage temperature and / or humidity conditions in real-time.

[0016] The systems and methods may use a device that utilizes a housing that defines distinct regions including a reaction region where electrochemical sensing occurs and an electronics section that houses control circuitry. This architectural separation enables environmental control to be focused specifically on the reaction region where it may be used to enhance electrochemical performance. The environmental control system may include a thermal control system with temperature sensors and thermal actuators, as well as a humidity control system with humidity sensors and optional humidity actuators.

[0017] The systems and methods may use a set of environment sensors to monitor conditions and a set of environment actuators to augment the environment conditions.

[0018] The systems and methods are preferably used in combination with an electrochemical sensing system. In some variations, the electrochemical sensing system can include or be a three-electrode system where at least one electrode (e.g., a working electrode) maybe an electrode element that functions as a site for an electrochemical reaction.

[0019] The systems and methods for an environment-controlled potentiostat device may be used to make use of electrochemical tests more accessible and easier to conduct.ESEN-M03-PCT

[0020] The systems and methods maybe adapted or configured to enable a potentiostat device, which may be used for monitoring a wide variety of different types of molecules. The systems and methods preferably use at least one electrochemical sensing electrode system which may be used in any suitable type of chemical / substance analysis monitoring use case.

[0021] In particular, the systems and methods may be used in enabling a mobile potentiostat device. The systems and methods may be configured for mobile use in the field through integration of environmental sensors and modulators directly within the reaction region, which reduces power requirements and enables compact device architecture. This integrated approach results in a smaller more mobile device, as integration of environmental control systems into the actual reaction chamber makes control of environmental conditions less power intensive compared to external environmental control approaches.

[0022] In one use-case, the systems and methods may enable a potentiostat device that can be used in connection with hormone measurement or monitoring. In one example cortisol levels may be monitored using the systems and methods. The environmental control capabilities enhance the reliability of hormone detection by maintaining optimal conditions for molecular binding and electrochemical reactions. Cortisol molecules or corresponding template molecules maybe used in creating defined cavity impressions in a polymer layer of the enhanced electrode. A cortisol contained in a tested sample passes through the hydrogel guard layer and becomes captured in the defined cavity impressions thereby changing electrical characteristics of the working electrode. These changes can be detected and measured to assess the quantity of cortisol in a sample. The working electrode may be configured with defined cavities for testing and evaluating quantities of other targeted molecules or combinations of molecules.

[0023] In another use-case, the systems and methods may enable a potentiostat device that can be used in connection with disease biomarker detection such as tracking for one or more biomarkers associated with diseases or conditions such as cancer, Alzheimer's, cardiovascular disorders, diabetes, kidney disease, liver disease, thyroid disorders, and the like. The controlled environmental conditions provided by the systems and methods enhance the sensitivity and specificity of biomarker detection,ESEN-M03-PCT particularly important for early-stage disease markers that may be present in low concentrations.

[0024] In another use-case, the systems and methods may enable a potentiostat device that can be used in connection with hydration and / or nutrition monitoring. The systems and methods may be used to measure electrolytes, ions, salts or lactate, a byproduct of glucose breakdown, and / or any other nutrition or hydration related markers. The mobile utility enabled through the systems and methods may be useful to enable reliable electrolyte monitoring in field conditions, supporting applications in sports medicine, military operations, and / or remote health monitoring.

[0025] As another related use-case, the systems and methods may enable a potentiostat device that can be used in connection with monitoring metabolic markers such as urea or creatinine. The system and method could similarly be used in monitoring chronic health conditions such as heart failure and / or chronic kidney disease. The stable environmental conditions provided by the integrated control system enhance the precision required for monitoring subtle changes in metabolic markers over time. With greater reliability, such a device of the systems and methods may be used more easily for testing at home for more frequent testing as one exemplary application.

[0026] In another use-case, the systems and methods may be used in connection with food safety testing, where food-borne pathogens or toxins can be monitored. The mobile and environmentally controlled nature of the device enables on-site food safety testing in processing facilities, restaurants, and field locations where rapid results are critical for safety decisions.

[0027] In one use-case, the systems and methods may be used in connection of environmental monitoring, wherein an enhanced electrode is configured for monitoring for specific molecules in environmental samples. Applications may include water quality testing, soil contamination analysis, and air quality monitoring where the integrated environmental control enables reliable sensing despite varying ambient conditions.

[0028] The systems and methods may also be applied to defense and security applications where portable, reliable chemical detection is required in field environments. The environmental control capabilities ensure consistent performance across diverse operational conditions while the mobile architecture enables deploymentESEN-M03-PCT in remote or challenging environments where traditional laboratory-based analysis is not feasible.

[0029] While the systems and methods are primarily described in connection with these specific applications, they may alternatively be used for any suitable electrochemical analysis application where environmental control enhances sensing performance or where mobile operation provides operational advantages.

[0030] The system and method may provide a number of potential benefits. The system and method are not limited to always providing such benefits and are presented only as exemplary representations for how the system and method maybe put to use. The list of benefits is not intended to be exhaustive, and other benefits may additionally or alternatively exist.

[0031] As one potential benefit, the systems and methods may make the output of the electrochemical sensor more reliable. The systems and methods can remove variability caused by secondary factors like temperature and humidity, causing the electrochemical reactions to more closely follow expected patterns. By maintaining precise environmental conditions within the reaction region through the environmental control system, the systems and methods may reduce interference from ambient temperature fluctuations and humidity variations that can affect reaction kinetics, electrode performance, and / or signal stability. The thermal control system and humidity control system may work in coordination to establish repeatable conditions that enhance measurement reproducibility across different testing environments and / or performing different electrochemical tests. This can make interpretation of data from an electrochemical sensor more reliable and reduce errors.

[0032] As another potential benefit, the systems and methods may be incorporated into a compact and portable device. While the form factor is not necessarily restricted to small form factors, the systems and methods may enable a potentiostat that can be more easily used in the field. The integration of environmental control capabilities directly within the device housing may eliminates the need for external environmental chambers or laboratory infrastructure, significantly reducing the overall system footprint. Furthermore, the localized environmental control within the reaction region requires less power than external room-scale environmental control systems, enabling battery- powered operation through the battery power supply. This integrated architecture mayESEN-M03-PCT make field deployment practical while maintaining the environmental control necessary for reliable electrochemical sensing.

[0033] As another potential benefit, the systems and methods may result in a potentiostat device that is more user-friendly than other traditional systems. The systems and methods may automatically perform electrochemical sensing of an analyte while dynamically adjusting the environment conditions in the reaction zone based on the desired conditions for the test and the current conditions. A controller can manage environmental control operations automatically, reducing the complexity of device operation and eliminating the need for users to manually manage environmental conditions. The automated environmental management through feedback control algorithms allows users to focus on sample preparation and result interpretation rather than environmental parameter management, making the technology accessible to users with varying levels of technical expertise.

[0034] As another potential benefit, the systems and methods may provide rapid environmental response times due to the small volume of the reaction region and the localized nature of the environmental control system. The microvolume reaction chamber may enable faster thermal equilibration and humidity adjustment compared to larger external environmental chambers. The thermal control system and humidity control system can achieve target environmental conditions more quickly when operating on the small volume of the reaction region, reducing the time required for environmental stabilization before analysis and enabling faster overall analysis cycles.

[0035] As another potential benefit, the systems and methods may enable reliable electrochemical analysis in field environments where traditional laboratory-based analysis is not feasible. The integrated environmental control allows the device to maintain analytical performance despite varying ambient conditions such as temperature extremes, high humidity, or other challenging environmental factors. This capability extends the applicability of high-precision electrochemical analysis to applications in remote monitoring, on-site testing, mobile laboratories, and field research where maintaining controlled conditions through external infrastructure would be impractical or impossible.

[0036] As another potential benefit, the systems and methods may provide enhanced versatility across different electrochemical sensing technologies and applications. TheESEN-M03-PCT environmental control capabilities can enhance the performance of various electrode configurations including molecular imprinted polymer sensors, screen-printed electrodes, and other electrochemical sensor technologies. The controller 140 can be programmed with multiple environmental profiles to optimize conditions for different types of analyses, enabling a single device to support diverse analytical applications while maintaining optimal environmental conditions for each specific use case.2. System

[0037] As shown in FIGURE 1, a system may include a housing no defining a defined reaction region 112; an electrochemical sensor 120 positioned within the reaction region 112; an environmental control system 130 positioned to monitor and affect the reaction region 112; and a controller 140 connected to the electrochemical sensor 120 and the environmental control system 130.

[0038] In some variations, the environmental control system 130 is positioned to affect environmental conditions within the reaction region 112, and the housing 110 further defines an electronics section 114 physically separated from the reaction region 112. The system may further include an electric interface through which the electrochemical sensor 120 conductively couples with electronics of the controller 140. This architectural separation may enable the environmental control system 130 to focus environmental management specifically on the reaction region 112 where electrochemical sensing occurs, while protecting the electronics section 114 from environmental fluctuations that could affect control circuitry performance.

[0039] As another variation, the environmental control system 130 may include a thermal control system 131 and a humidity control system 135 as shown in FIGURE 2. The thermal control system 131 may include a thermal modulator 133 configured to change temperature in the reaction region 112 and include a temperature sensor 132 positioned to monitor temperature within the reaction region 112. The humidity control system 135 may include a humidity sensor 136 positioned to monitor humidity within the reaction region 112. In some variations, the humidity control system 135 may additionally include a humidity modulator 137 configured to actively control humidity levels within the reaction region 112. The thermal control system 131 and humidityESEN-M03-PCT control system 135 may operate independently or in coordination to maintain target environmental conditions within the reaction region 112.

[0040] As also shown in FIGURE 2, a system variation for battery-powered operation may include the housing 110, electrochemical sensor 120, environmental control system 130, and controller 140, and may further include a battery power supply 150 configured to provide electrical power to the environmental control system 130 and the controller 140. This system variation enables portable operation independent of external power sources while maintaining full environmental control capabilities.

[0041] In some variations, the system may be configured as a microvolume reaction system where the reaction region 112 is dimensioned to contain sample volumes between 10 microliters and 1000 microliters. The thermal control system 131 and humidity control system 135 may provide environmental response times of less than 30 seconds due to the small volume of the reaction region 112. This microvolume approach enables rapid environmental control and faster analysis cycles while reducing sample volume requirements.

[0042] The housing 110 functions as an enclosure structure or casing body to contain and organize components of the potentiostat. The housing can further enable environmental control within a defined region. The enclosure housing in one variation is a rigid structure or set of rigid structures that holds or otherwise contains the components. The housing 110 maybe alternatively referred to as an enclosure housing or casing body. The housing no maybe made of one or multiple distinct parts and / or materials.

[0043] The housing 110 in one preferred variation includes a defined reaction region that can be substantially or at least partially isolated from external conditions. In one variation, the housing 110 may include thermal insulation material (entirely or partially) surrounding the reaction region 112 and / or thermal barriers positioned between the reaction region 112 and external surfaces of the housing 110. This thermal isolation architecture enables environmental control despite external conditions and maintains temperature differentials between the reaction region 112 and ambient environment. The electrochemical sensor system 120 is preferably integrated to perform electrochemical sensing within the reaction region 112. The housing 110 may contain other components in other defined chambers or compartments.ESEN-M03-PCT

[0044] As one variation, the housing 110 maybe a rigid structure or set of rigid structures constructed from materials that provide thermal stability and environmental isolation. The housing 110 may include multi-layer insulation, vacuum insulation panels, or other thermal management materials that enhance the effectiveness of the environmental control system 130. Alternatively, the housing 110 maybe constructed from alternative convention materials such as plastic, metal, or composite materials which may provide structural integrity while enabling cost-effective manufacturing. The housing 110 maybe dimensioned to optimize the balance between environmental control effectiveness and overall device portability.

[0045] In some variations, the housing 110 may include an openable lid or access panel that provides access to the reaction region 112 for sample introduction or electrode replacement. The lid may include sealing mechanisms such as gaskets or seals that maintain environmental isolation when closed. The housing 110 may include latching or locking mechanisms that secure the lid during operation while enabling easy access when needed. In one exemplary variation, the reaction region 112 may be accessed through a hinged lid of the housing 110 as shown in FIGURE 1. The lid maybe opened to deposit a sample or to change an electrochemical sensor 120 when the sensor is an interchangeable component and maybe closed when conducting a test.

[0046] Alternatively, the housing 110 may include a sample inlet system that enables sample introduction without opening the reaction region 112 to ambient conditions. The sample inlet may include microfluidic channels, injection ports, or other sample delivery mechanisms that maintain environmental control during sample introduction. For example, microfluidic channels may be used to receive a sample in one element of the system, and then fluidically transport the sample into the reaction region 112 where it maybe deposited or exposed to the electrochemical sensor 120. The sample inlet system may be designed to maintain environmental control during sample introduction and transport. This approach enables continuous environmental control throughout the analysis process.

[0047] In another variation, the reaction region 112 may be within a sealing chamber that can be set to an open state to receive an analyte and then closed during the electrochemical reaction and analysis. A sample for analysis maybe delivered via an inlet or through a moving actuator to move a sample into the reaction region 112. In oneESEN-M03-PCT variation, this may be implemented through sample cartridges that may be added or removed from the device. The sample cartridges may also include in part or whole part of the electrochemical sensing system 120.

[0048] The reaction region 112 functions as a controlled environment space where electrochemical sensing occurs and where environmental conditions are actively managed by the environmental control system 130. The reaction region 112 maybe alternatively referred to as a reaction chamber, sensing chamber, or controlled environment zone.

[0049] The reaction region 112 is preferably a defined space that, at least during operation of the electrochemical sensor 120, maybe enclosed with physical separation from the outside environment. Accordingly, the reaction region 112 could be insulated and fully enclosed from external conditions. However, in some cases a partial physical separation within the device and / or with an external environment maybe used. The reaction region 112 may be dimensioned as a microvolume chamber to enable rapid environmental response and efficient environmental control. In some variations, the reaction region 112 contains sample volumes between 10 microliters and 1000 microliters, with some implementations targeting volumes between 50 microliters and 500 microliters for enhanced environmental control performance.

[0050] The reaction region 112 may include environmental monitoring points where temperature sensors 132 and humidity sensors 136 are positioned to provide feedback to the controller 140. The reaction region 112 may include thermal contact surfaces that interface with thermal modulators 133 of the thermal control system 131. Similarly, the reaction region 112 may include humidity management interfaces that enable controlled exposure to desiccant materials or other humidity modulators 137.

[0051] An electronics section 114 of the housing 110 may function as a physically separated region within the housing 110 that contains control electronics, processing components, and other electronic systems that are isolated from the environmental conditions maintained within the reaction region 112.

[0052] The electronics section 114 may be physically separated from the reaction region 112 through thermal barriers, environmental isolation barriers, or other separation mechanisms that prevent environmental conditions in the reaction region 112 from affecting electronics performance. The electronics section 114 may maintainESEN-M03-PCT ambient environmental conditions or may have independent environmental management optimized for electronic component operation. In general, the electronics section 114 is of the housing is a result of subdividing the reaction region 112 within the housing.

[0053] In one variation, the electronics section 114 may include the controller 140, power management circuits, communication interfaces, and other electronic systems required for device operation. The electronics section 114 may include thermal management systems such as heat sinks, thermal pads, or ventilation systems that maintain appropriate operating temperatures for electronic components. The electronics section 114 may be designed to operate effectively across a range of ambient conditions while the reaction region 112 maintains precisely controlled conditions.

[0054] The electronics section 114 may include electrical interfaces that enable communication and power transfer between components in the electronics section 114 and components within the reaction region 112. These interfaces may include sealed electrical feedthroughs, flexible circuit connections, or other connection mechanisms that maintain environmental separation while enabling electrical connectivity.

[0055] The electrochemical sensing system 120 functions as a system that converts an electrochemical reaction to electrical signals. In particular, the electrochemical sensor is one that can be used in detecting, quantifying and / or otherwise characterizing chemical properties of a sample.

[0056] The electrochemical sensing system 120 may include one or more electrochemical sensors, support electronics, and interface components that work together to enable electrochemical analysis within the environmentally controlled reaction region 112.

[0057] The electrochemical sensing system 120 may be implemented using various electrochemical analysis approaches, each of which can benefit from the environmental control provided by the environmental control system 130. These approaches may include voltammetric sensors that measure current response to applied voltage changes, amperometric sensors that measure current at a fixed applied potential, potentiometric sensors that measure voltage or potential differences, impedimetric sensors that measure electrical impedance changes, and conductometric sensors that measureESEN-M03-PCT changes in electrical conductivity. The environmental control capabilities enhance the performance and reliability of each of these electrochemical sensing approaches.

[0058] In some variations, the electrochemical sensing system 120 may be configured as a voltammetric sensor that measures current response to applied voltage changes. Voltammetric techniques may include cyclic voltammetry, differential pulse voltammetry, square wave voltammetry, and other voltage-scanning methods. The environmental control system 130 enhances voltammetric measurements by maintaining stable temperature and humidity conditions that affect the kinetics of electrochemical reactions and the stability of voltage-current relationships.

[0059] In some variations, the electrochemical sensing system 120 may be configured as an amperometric sensor that measures current at a fixed applied potential.Amperometric sensors may be used in various biosensors, glucose monitors, and other applications where current changes indicate analyte concentration. The environmental control system 130 benefits amperometric measurements by reducing baseline drift and noise that can result from temperature and humidity fluctuations affecting electrode surface conditions and solution properties.

[0060] In some variations, the electrochemical sensing system 120 may be configured as a potentiometric sensor that measures voltage or potential differences between electrodes. Potentiometric sensors may include ion-selective electrodes, pH sensors, and other sensors that respond to specific ion concentrations. The environmental control system 130 enhances potentiometric measurements by maintaining stable conditions that affect electrode potentials and reference electrode stability.

[0061] In some variations, the electrochemical sensing system 120 may be configured as an impedimetric sensor that measures electrical impedance changes in response to analyte binding or other electrochemical processes. Impedimetric measurements may utilize electrochemical impedance spectroscopy techniques for label-free detection of molecular binding events. The environmental control system 130 benefits impedimetric measurements by maintaining stable conditions that affect the dielectric properties and ionic conductivity of the measurement environment.

[0062] In one particular variation, the electrochemical sensing system can include or be a three-electrode system where at least one electrode (e.g., a working electrode) may be an electrode element that function as a site for an electrochemical reaction. A three-ESEN-M03-PCT electrode system can be a sensing electrode system that includes a working electrode, a reference electrode, and a counter electrode. The working electrode may be an enhanced working electrode. In one variation, the working electrode may include a molecular imprinted polymer layer and a hydrogel guard layer.

[0063] The three-electrode system and the electrochemical sensing system more generally may be used to process a sample to detect and quantify a specific analyte (i.e., target molecule) in a sample. An enhanced electrode as may be used in a working electrode of a three-electrode system functions to provide variable electrical properties based on exposure to a sample and the amount of an analyte in the sample.

[0064] The enhanced electrode may be prepared and configured for reacting to one or more types of target molecules. More specifically, the enhanced electrode may be prepared through an imprintation process where targeted molecules are used to create nano-scale cavities defined in portions of the enhanced electrode. When used, those cavities may be filled by the targeted molecules if the molecule is present and moves into the cavity. The number of cavities filled by molecules results in changing electrical properties of the enhanced electrode.

[0065] The enhanced electrode may be imprinted and customized for a variety of different targeted analytes. In particular, the enhanced electrode may target measuring of hormones, electrolytes, and / or inflammatory markers.

[0066] The enhanced electrode of one variation may include a set of layers or structures that function as a filter, a sensing element, and a highly conductive electrode element. In particular, the enhanced electrode may include a conductive layer deposited on a substrate, a molecular imprinted polymer (MIP) layer deposited on the conductive layer, a hydrogel guard layer on the conductive layer. The hydrogel guard layer can include a redox mediator material integrated within the hydrogel guard layer. The MIP layer is imprinted with template molecules defining cavities for a target molecule or molecules of an analyte of interest. In some variations, the MIP layer may additionally include integrated nanoparticles to further facilitate enhanced sensing capabilities of the enhanced electrode as shown in FIGURE 2. 2D printing technology maybe used in part to form such an electrode and / or electrode system.

[0067] The hydrogel guard layer in connection with the redox mediator material functions to filter non-targeted particles and molecules while allowing targetedESEN-M03-PCT molecules of the analyte to transition or diffuse into the MIP layer. Within the MIP layer, the analyte will have individual molecule instances captured in the defined cavities of the MIP layer, which thereby alters electrical properties when driving the electrode via the conductive layer.

[0068] In particular, the enhanced electrode may be integrated as part of an electrochemical sensor element that further includes a reference electrode and a counter electrode, as shown in FIGURE 3. This configuration allows for additional calibration and reference signals, resulting in improved interpretation of measurements obtained from the enhanced electrode.

[0069] In some variations, the electrochemical sensor may utilize 2D fabrication design such that a sensing electrode may be printed or otherwise produced through stacked layering of electrochemical components. In this way, the systems and methods described herein maybe used in making small form-factor sensing electrodes, which may be integrated into biosensor devices. For example, the sensing electrode may be part of a sensing strip that can be affordably used and replaced. This may enable more regular testing, and easier testing, which may open up at-home and / or mobile testing of various analytes. 2D fabrication may additionally be used in fabrication of all three electrodes.

[0070] Other alternative electrochemical sensing elements may additionally or alternatively be used.

[0071] In one variation, the electrochemical sensor comprises a single electrochemical sensor element. This sensor may be configured to sense a single analyte, though in some variations, multiple analytes may be collectively sensed.

[0072] In another variation, the system may include a multi-channel electrochemical sensor system. In one such variation, the system may include multiple distinct electrochemical sensor elements. For example, there may be multiple three-electrode systems (or optionally three different enhanced working electrodes), which may be used to each measure a different aspect. For example, three different distinct electrochemical sensor elements maybe used to measure three different analytes.

[0073] In some variations, the system maybe implemented as a single use system, which will generally be used for performing one configured analysis. In such a system the electrochemical sensor maybe integrated into the system. Depending on theESEN-M03-PCT electrochemical sensor, multiple uses may be performed by such a device. In some variations, the electrochemical sensor may be one that can be reset for subsequent or otherwise be reusable. Alternatively, the device may be a single-use disposable system, that after usage it can be disposed of.

[0074] In an alternative variation, the electrochemical sensor may be interchangeable wherein the electrochemical sensor could be changed and / or otherwise altered or used for monitoring different electrochemical reactions. The electrochemical sensing system 120 maybe integrated into a removable electrode cartridge. The electrochemical sensor may be integrated into a cartridge, strip, or other form factor that may be added or removed from the system. Different electrochemical sensors maybe configured for performing different analysis. Alternatively, the electrochemical sensors maybe interchangeable to facilitate continued use of the system after a sensor becomes unusable.

[0075] In some variations, a testing cartridge may include the electrochemical sensing system 120 or a subset of components of the electrochemical sensing system 120. For example, a cartridge may contain a three-electrode system with an enhanced electrode which can be used to collect a sample, and then when inserted into the housing no engages conductively with testing circuitry to facilitate the electrochemical testing.

[0076] With a system that can measure different forms of analysis, the system may target different environmental conditions based on the type of electrochemical sensor.

[0077] The environmental control system 130 functions as an environmental management system that monitors and optionally controls environmental conditions within the reaction region 112. The environmental control system 130 maybe alternatively referred to as an environmental monitoring system, environmental management system, or environmental conditioning system that augments environmental conditions based in part on conditions detected by sensing components. The environmental control system 130 maybe used to target environmental conditions within the reaction region 112 and maybe controlled by the controller 140 based on data from environmental sensors.

[0078] The environmental control system 130 may include a set of environment sensors that monitor current conditions. The environmental control system 130 mayESEN-M03-PCT additionally include one or more environment modulators that adjust conditions to achieve target parameters. This integrated sensing and control approach may enable real-time environmental management within the localized reaction region 112 for enhanced electrochemical analysis. In some variations, the environmental control system 130 may additionally include sensors for sensing external conditions. Alternatively, external environment data may be received from an external source.

[0079] The environmental control system 130, in one variation, includes a thermal control system 131 and a humidity control system 135. As one variation, the thermal control system 131 and humidity control system 135 may operate independently to manage their respective environmental parameters. Alternatively, the thermal control system 131 and humidity control system 135 may operate in coordination to prevent interference between temperature and humidity control operations, as changes in temperature can affect humidity levels and vice versa.

[0080] The environmental control system 130 may include other environment modulator elements to alter additional aspects of the environment beyond temperature and humidity. For example, the environmental control system 130 may include a pressure system which may function to alter the atmospheric pressure in the reaction region 112. The environmental control system 130 may include additional or alternative environmental sensing and / or modulators for other environmental parameters as needed for specific electrochemical sensing applications.

[0081] A thermal control system 131 functions to monitor and control temperature within the reaction region 112. The thermal control system 131 maybe alternatively referred to as a temperature control element, thermal management system, or temperature conditioning system that changes temperature in the reaction region 112.

[0082] The thermal control system 131 may include one or more temperature sensors 132 positioned to monitor temperature within the reaction region 112. The temperature sensor 132 functions to monitor temperature conditions within the reaction region 112 and provide temperature data to the controller 140. The temperature sensor(s) 132 may provide temperature feedback to the controller 140 for closed-loop temperature control. The temperature sensor 132 may be positioned at strategic locations within the reaction region 112 to provide accurate temperature monitoring of the electrochemical sensing environment.ESEN-M03-PCT

[0083] A temperature sensor 132 maybe a thermistor, a thermocouple, a resistance temperature detector (RTD), a semiconductor temperature sensor, infrared (IR) temperature sensor, or any suitable type of temperature sensor. In some variations, multiple types of temperature sensors 132 maybe used in combination to provide redundant temperature monitoring or to monitor temperature at multiple locations within the reaction region 112.

[0084] The thermal control system 131 may additionally include a thermal modulator 133 that functions to alter the temperature in the reaction region H2.The thermal modulator 133 may actively change temperature within the reaction region 112 in response to control signals from the controller 140. This will generally be based on temperature data from the temperature sensor 132.

[0085] A thermal modulator 133 may actively cool and / or heat the reaction region 112 to achieve target temperature conditions. The thermal modulator 133 may include resistive heaters, Peltier modules (e.g., thermoelectric devices to cool or heat), fans or ventilation systems, and / or other heating and / or cooling elements.

[0086] In some variations, the thermal modulator 133 includes a Peltier thermoelectric module that provides bidirectional temperature control capability. The Peltier thermoelectric module may operate in both heating and cooling modes to maintain target temperature conditions regardless of ambient temperature variations.

[0087] As another variation, the thermal modulator 133 may include a fan assembly integrated with the Peltier thermoelectric module to provide forced convection cooling and enhance thermal management efficiency. The fan assembly may improve heat transfer and enable more rapid temperature changes within the reaction region 112.

[0088] In yet another alternative variation, the thermal modulator 133 may include resistive heating elements, ceramic heaters, or other heating technologies that provide temperature increase capabilities. In some variations, the thermal modulator 133 may include separate heating and cooling elements that operate independently to provide precise temperature control. The thermal modulator 133 may be designed to provide rapid temperature response due to the small volume of the reaction region 112.

[0089] The humidity control system 135 functions to monitor humidity levels within the reaction region 112. The humidity control system 135 may additionally function to modulate the humidity conditions within the reaction region 112. The humidity controlESEN-M03-PCT system 135 may be alternatively referred to as a humidity control element, moisture management system, or humidity conditioning system that alters humidity in the reaction region 112.

[0090] The humidity control system 135 may include one or more humidity sensor S136 positioned to monitor humidity within the reaction region 112. The humidity sensors may provide humidity data to the controller 140. In some variations, the controller 140 may use the humidity data for closed-loop humidity control. The humidity sensor 136 maybe strategically positioned within the reaction region 112 to accurately monitor the humidity conditions affecting the electrochemical sensing system 120. As with the temperature sensors, one or more humidity sensors 136 may also be positioned to sense the environment external to the reaction region 112.

[0091] A humidity sensor 136 may be a capacitive humidity sensor, a resistive humidity sensor, a thermal conductivity sensor, polymer-based humidity sensor, and / or other type of humidity sensor. In some variations, multiple types of humidity sensors 136 and / or multiple humidity sensors 136 maybe used in combination to provide accurate humidity monitoring across different humidity ranges or at multiple locations within the reaction region 112.

[0092] The humidity control system 135 may in some variations include one or more humidity modulators 137, which function to alter humidity levels in the reaction region 112. In one variation, the humidity modulator 137 is a dehumidification element that absorbs and releases humidity to control moisture levels within the system. The humidity modulator 137 may also be configured to increase humidity in some variations, providing bidirectional humidity control capabilities.

[0093] In one exemplary implementation, the humidity modulator 137 may include a deployable hydrophilic material or desiccant material that includes controlled exposure to the reaction region 112. The humidity modulator 137 may include desiccant material positioned for controlled exposure to the reaction region 112, enabling precise humidity management through variable desiccant surface area exposure.

[0094] A desiccant material like silica gel, activated charcoal, Calcium Chloride, Diethylene Glycol, Calcium Sulfate, and / or Zeolites and the like maybe exposed to the reaction region 112 to reduce humidity, and then removed from the reaction region 112 when the humidity reaches a desired level. The humidity modulator 137 may include aESEN-M03-PCT heating element configured to regenerate the desiccant material by removing absorbed moisture for additional absorption of moisture. The heating element may remove absorbed moisture from the desiccant material to restore its humidity absorption capacity. In one variation, the heating element may also be the serve as the temperature modulator 133. In some such variations, the temperature modulator may run a desorbing heat cycle for a desiccant sorbent material when electrochemical analysis is not being performed so as to prepare the desiccant material for later use.

[0095] As one variation, the humidity modulator 137 may include a motorized mechanism configured to incrementally adjust desiccant surface area exposure to the reaction region 112 in response to humidity sensor 136 feedback. The motorized mechanism may enable humidity control resolution of less than 2% relative humidity through precise control of desiccant material exposure. The motorized mechanism may include sliding mechanisms, rotating mechanisms, or other actuators that vary desiccant surface area exposure based on proportional humidity control requirements.

[0096] A humidity modulator 137 may also be used to increase humidity in some variations. To increase humidity, a humidity modulator 137 could include an evaporative humidifier, which could use a wick or filter pad to absorb water from a reservoir, and a fan that blows air to evaporate water thereby adding moisture to the reaction region 112. In another variation, the humidity modulator 137 could include a piezoelectric atomizer to create mist and disperse moisture into the air within the reaction region 112.

[0097] The controller 140 functions to control and operate the device. The controller 140 maybe alternatively referred to as a potentiostat electronic control system, control system, or electronic control system that manages the operation of the electrochemical sensing system 120 and environmental control system 130. The controller 140 maybe a digital and / or electronic control system that is connected to the electrochemical sensing system 120, the environmental sensors within the environmental control system 130, and the environmental modulators of the environmental control system 130.

[0098] In one variation, the controller 140 includes a microprocessor or another suitable processing system, which may include instructions stored in a computer readable medium (e.g., a non-transitory computer readable medium) that maybe specially configured such that when executed by the processing system causes theESEN-M03-PCT system to operate the potentiostat device. The controller 140 may include a microcontroller, digital signal processor, field-programmable gate array (FPGA), application-specific integrated circuit (ASIC), or other suitable processing components that enable real-time control of environmental conditions and electrochemical sensing operations. The operations of the potentiostat may include the various processes described herein.

[0099] In particular, the controller 140 may include a microcontroller programmed with a feedback control algorithm configured to adjust the thermal control system 131 and humidity control system 135 based on readings from the temperature sensor 132 and humidity sensor 136. The feedback control algorithm may implement proportionalintegral-derivative (PID) control, adaptive control, or other suitable control algorithms that maintain environmental conditions within predetermined tolerance ranges throughout electrochemical analysis operations.

[0100] In particular, the controller 140 may monitor the environment conditions in the reaction region 112 using the environmental sensors of the environmental control system 130 and then alter the environment conditions in the reaction region 112 to target desired conditions using the environmental modulators of the environmental control system 130. The controller 140 may implement closed-loop control where environmental sensor feedback is continuously monitored and environmental modulators are adjusted in real-time to maintain target conditions. This closed-loop approach enables precise environmental control despite external disturbances or changes in ambient conditions.

[0101] With a system that can measure different forms of analytes, the controller 140 may target different environmental conditions based on the type of electrochemical sensing system 120. The controller 140 maybe programmed with multiple environmental profiles, each profile defining target temperature and humidity conditions for different analysis types. The environmental profiles may be user- selectable to optimize conditions for specific analytical applications or may be automatically selected based on the type of electrochemical sensing system 120 or analyte being analyzed. Alternatively, selection or configuration of the device for a particular type of electrochemical analysis may initiate use of a select environmental profile.ESEN-M03-PCT

[0102] In some cases, the type of electrochemical analysis and / or type of targeted environmental profile may be signaled through receiving of an electrochemical sensor. For example, an electrochemical sample cartridge may include an RFID tag or other signaling component that indicates the type of test and / or type of environment to be used.

[0103] In some variations, the targeted environmental conditions may be consistent across all uses of the device. As such the targeted temperature and / or humidity maybe preconfigured in the device.

[0104] In addition to or as an alternative to modulating one or more environmental conditions, the controller 140 may also include signaling outputs such as indicator lights, graphical display indicators, audio alerts that can be triggered to note if and when the environmental conditions are within and / or outside suitable target ranges. For example, a device without a humidity modulator may have a warning light come on if the humidity is outside recommended humidity parameters.

[0105] In some variations, the environmental conditions maybe altered based on received data or operating parameters. In one example, the controller 140 may include control configuration to set a targeted electrochemical sensing rate or analysis mode. Depending on the configured speed of the electrochemical sensing / analysis, the controller 140 may alter the environmental conditions to speed up or slow down a reaction. In some cases, altering the temperature may affect the speed of an electrochemical reaction but possibly with some tradeoffs like accuracy or precision. Accordingly, the controller 140 may enable selectable testing modes, which could include a fast analysis mode and / or a precise / high-accuracy mode with corresponding environmental control parameters.

[0106] The controller 140 may include environmental monitoring and safety features that protect the electrochemical sensing system 120 and prevent damage from environmental extremes. The controller 140 may implement temperature and humidity limits, timeout functions, and error detection algorithms that ensure safe operation across varying ambient conditions. The controller 140 may provide status indication, alarm functions, or automatic shutdown capabilities when environmental conditions cannot be maintained within acceptable ranges.ESEN-M03-PCT

[0107] The controller 140 may include communication interfaces that enable data transfer, remote monitoring, or integration with external systems. Communication interfaces may include wired connections such as USB, Ethernet, or serial interfaces, or wireless connections such as Wi-Fi, Bluetooth, or cellular communication. These interfaces may enable data logging, remote control, firmware updates, or integration with laboratory information management systems (LIMS).

[0108] In some variations, the controller 140 may implement distributed processing where control and analysis functions are shared between the device and external computing systems. In one example, the controller 140 may handle real-time environmental control and basic electrochemical sensing operations, while an application operable on a smart device, tablet, or computer may provide advanced data analysis, user interface functions, data storage, or connectivity features. This distributed architecture may enable the device to maintain a compact form factor while providing sophisticated analysis capabilities through integration with more powerful external computing resources.

[0109] The controller 140 or the system more broadly may additionally include or be connected to a power source like a battery power supply 150 or electrical outlet and / or a user interface system. The user interface system may include input and / or output components that can be used by a user to operate the device. Inputs may include buttons, switches, touchscreen interfaces, or other input mechanisms used to initiate sensing, select analysis modes, set configuration parameters, or control device operation. The outputs may include a screen, indicator lights, audio alerts, and / or other output components to signal information to an operator such as system status, analysis results, environmental conditions, or alarm conditions.

[0110] The battery power supply 150 functions to provide electrical power to the environmental control system 130 and the controller 140, enabling portable operation independent of external power sources. The battery power supply 150 maybe alternatively referred to as a power source, energy storage system, or portable power system that enables field operation and mobile use of the device.

[0111] The battery power supply 150 may include rechargeable battery technology such as lithium-ion, lithium-polymer, nickel-metal hydride, or other suitable rechargeable battery chemistries that provide adequate energy density for portableESEN-M03-PCT operation. The battery power supply 150 or the system more generally may include battery management systems that monitor battery state, control charging, and optimize power consumption to extend operational time.

[0112] As one variation, the battery power supply 150 may be designed to provide sufficient power for extended field operation, enabling multiple analysis cycles or continuous monitoring applications without requiring external power connections. The battery power supply 150 may include power management features that optimize power consumption of the environmental control system 130, particularly the thermal and humidity control operations that may represent significant power loads.

[0113] The battery power supply 150 may include charging interfaces such as USB charging ports, wireless charging capabilities, or dedicated charging connectors that enable battery recharging between uses. The battery power supply 150 may include power indicators, low battery warnings, or other user interface elements that communicate power status to operators.3. Method

[0114] A method for operating a sensing electrode system, as shown in FIGURE 4, may include sensing state of environment conditions in a reaction region of a potentiostat device S110; augmenting the environment conditions in the reaction region of the potentiostat device based on the state of environment conditions S120; receiving a sample exposed to a sensing electrode system S130; and analyzing the sample using the sensing electrode system S140.

[0115] The method is preferably implemented by a system substantially similar to the systems and system variations described herein. However, the method may alternatively or additionally be performed by other alternative suitable systems.

[0116] As one variation, the method may be operated using pre-configured or fixed target environment conditions. In other variations, the method may more dynamically adjust the environment conditions based on an operating mode of the potentiostat device, the type of analysis, and / or external environmental conditions.

[0117] In some variations, the method maybe used for managing temperature and humidity for a potentiostat with enhanced electrochemical analysis. As shown inESEN-M03-PCTFIGURE 5, a method variation for detailed environmental control may include the primary steps Sno, S120, S130, and S140, and may further include sub-steps for specific environmental parameter management. Sensing state of environment conditions Sno may include monitoring temperature within the reaction region using a temperature sensor S112 and monitoring humidity within the reaction region using a humidity sensor S114. Augmenting the environment conditions S120 may include controlling temperature within the reaction region using a thermal modulator S122 and / or controlling humidity within the reaction region using a humidity modulator S124. These sub-steps enable precise management of individual environmental parameters that affect electrochemical sensing performance.

[0118] Block S110, which includes sensing state of environment conditions in a reaction region of a potentiostat device, functions to monitor current environmental parameters within the controlled environment where electrochemical sensing occurs. Sensing state of environment conditions may include monitoring temperature, humidity, pressure, and / or other environmental parameters that can affect electrochemical sensing performance.

[0119] As one variation, sensing state of environment conditions may include monitoring temperature within the reaction region using a temperature sensor and / or monitoring humidity within the reaction region using a humidity sensor. The temperature and humidity monitoring maybe performed continuously, periodically, or on-demand to provide environmental feedback for control operations.

[0120] In some variations, sensing state of environment conditions may include monitoring additional environmental parameters such as atmospheric pressure, air circulation, or other factors that may influence electrochemical reactions. The environmental sensing may provide real-time feedback to enable responsive environmental control and ensure optimal conditions for electrochemical analysis.

[0121] Sensing state of environment conditions will generally include sensing conditions within the reaction region. Sensing state of environment conditions may additionally include sensing conditions outside of the reaction region. As such, the method may also include sensing environment conditions outside the device.Alternatively, the method may include receiving external environment data from anESEN-M03-PCT external source. For example, temperature and humidity data for the current location may be access from an internet accessible weather service.

[0122] Block S112, which includes monitoring temperature within the reaction region, functions to provide temperature feedback for environmental control operations. Monitoring temperature may be performed using temperature sensors positioned within the reaction region to accurately measure the thermal conditions affecting electrochemical sensing.

[0123] Temperature may be measured by one sensor or a plurality of sensors. In some variations, one temperature sensor may be external to the device.

[0124] Block S114, which includes monitoring humidity within the reaction region, functions to provide humidity feedback for environmental control operations.Monitoring humidity may be performed using humidity sensors positioned within the reaction region to accurately measure the moisture conditions affecting electrochemical sensing. As with the temperature sensing, monitoring humidity may be measured by one sensor or a plurality sensor. In some variations, one humidity sensor maybe external to the device.

[0125] Block S120, which includes augmenting the environment conditions in the reaction region of the potentiostat device based on the state of environment conditions, functions to actively control and adjust environmental parameters to achieve target conditions for reliable electrochemical sensing.

[0126] Blocks S110 and S120 together may function to regulate environment conditions where the electrochemical reaction occurs. Sensing state of environment conditions and augmenting the environment conditions may more specifically include sensing temperature and / or humidity conditions in the reaction region and augmenting the temperature and / or humidity conditions in the reaction region based on the state of environment conditions.

[0127] In some variations, a control system (e.g., a microcontroller) of a potentiostat device will take measurements from a temperature sensor and / or humidity sensor and will activate the corresponding environmental modulators to achieve a stable environment for a constant temperature and humidity in a targeted range for the time an electrochemical experiment is taking place. When the device is turned on it may activate the modulators in order to reach a specific target environment condition range.ESEN-M03-PCT

[0128] In operation of such a device, temperature, humidity and battery may be displayed on a screen, with the messages corresponding to the selected temperature ranges. The device may show on screen if the battery is low and a screen to recharge it, it may display the selected mode with the corresponding set of temperature range and humidity. The selection of such conditions may be done by selection with an input element (e.g., input buttons, switches, dials, touchscreen etc.). The device may operate when it is turned on and will check the current temperature, if below the range set it will activate the thermoelectric heating cooling module to raise it, if the temperature is higher, it will activate it to bring it down to the range set. The humidity sensor will send information to the microcontroller, and the humidity modulator may be activated if the value of the sensor is out of range and can be addressed by the modulator.

[0129] As discussed, augmenting the environment conditions may include controlling temperature within the reaction region S122 using a thermal modulator system. Temperature control may include heating and / or cooling operations to maintain target temperature ranges regardless of ambient conditions.

[0130] As another variation, augmenting the environment conditions may additionally or alternatively include controlling humidity within the reaction region using a humidity control system. Humidity control may include humidification and / or dehumidification operations and may be coordinated with temperature control to prevent interference between temperature and humidity control operations.

[0131] In some variations, augmenting the environment conditions may include using a feedback control algorithm to adjust thermal and / or humidity modulator elements based on the sensed state of environment conditions. The feedback control algorithm may implement proportional-integral-derivative (PID) control or other suitable control approaches that maintain environmental stability.

[0132] Block S122, which includes controlling temperature within the reaction region, functions to maintain target temperature conditions for optimal electrochemical sensing performance. Controlling temperature may include operating a Peltier thermoelectric module to provide both heating and cooling of the reaction region. The Peltier thermoelectric module may provide bidirectional temperature control that responds to both increases and decreases in ambient temperature.ESEN-M03-PCT

[0133] As one variation, controlling temperature may include monitoring ambient temperature conditions and adjusting thermal control operations to compensate for external temperature variations. Temperature control may include rapid response capabilities that quickly adjust reaction region temperature when ambient conditions change or when different analysis modes require different temperature setpoints.

[0134] Block S124, which includes controlling humidity within the reaction region, functions to maintain target humidity levels for consistent electrochemical sensing conditions. Controlling humidity may include increasing exposure of a desiccant material to the reaction region to reduce humidity and decreasing exposure of desiccant material to the reaction region to increase humidity. This approach provides dynamic humidity control through variable desiccant surface area exposure. Controlling humidity may alternatively include adding moisture (e.g., water vapor) to the air in the reaction region.

[0135] As one variation, controlling humidity may further include detecting saturation of the desiccant material and heating the desiccant material to remove absorbed moisture and regenerate the desiccant material. The regeneration process may use a ventilation system to remove moisture during regeneration, enabling continued humidity control operation.

[0136] In a variation based on operating mode, augmenting the environment conditions may be further based on a received selection of an operating mode. The method may include receiving selection of one of a set of operating modes and setting target environment conditions based on the operating mode. The method may include receiving a selection of a sample analysis type and setting target environmental conditions within the reaction region based on the sample analysis type. Different operating modes may have different environmental parameter targets, analysis speeds, and / or accuracy objectives. Accordingly, augmenting the environment conditions in the reaction region of the potentiostat device based on the state of environment conditions S120 maybe further based on the type of electrochemical sensing system and / or analyte.

[0137] For example, a fast analysis mode may alter the environment conditions in the reaction region to accelerate the electrochemical reaction so as to obtain results at a faster rate. A precision analysis mode may prioritize environmental stability andESEN-M03-PCT measurement accuracy over analysis speed. The environmental control parameters may be adjusted accordingly, with fast modes potentially using higher temperatures to accelerate reactions while precision modes focus on maintaining extremely stable conditions.

[0138] In a variation based on the type of analysis, the type of electrochemical sensing system and / or the type of analyte being analyzed may call for different environment conditions. In one implementation, the method may include determining the electrochemical sensing system type and setting target environment conditions based on the electrochemical sensing system type. This may similarly be based on the type of analyte. Different analytes may have optimal temperature and humidity ranges that enhance detection sensitivity, selectivity, or reaction kinetics.

[0139] Block S130, which includes receiving a sample exposed to a sensing electrode system, functions to introduce the analyte sample into the controlled environment for electrochemical analysis.

[0140] As one variation, receiving a sample may include receiving the sample at a microfluidic sample inlet and transporting the sample to the reaction region through microfluidic channels while maintaining the augmented environment conditions. The sample transport system maybe designed to preserve environmental control during sample introduction and minimize environmental disruption.

[0141] As discussed, in a variation based on the type of analysis, the type of electrochemical sensor and / or the type of analyte being analyzed may call for a different environment condition. In one implementation, the method may include determining the electrochemical sensor type and setting target environment condition based on the electrochemical sensor type. This may similarly be based on the type of analyte. In this case, augmenting the environment conditions in the reaction region of the potentiostat device based on the state of environment conditions S120 maybe further based on the type of electrochemical sensor and / or analyte. For example, analysis of different analytes may benefit from different conditions and so those could automatically be set and applied within the reaction region.

[0142] In some variations, the method may include establishing target environmental conditions within the reaction region prior to receiving the sample, monitoring achievement of the target environmental conditions, and providing aESEN-M03-PCT readiness signal when the target environmental conditions are achieved. This preconditioning approach ensures stable environmental conditions before sample introduction.

[0143] In some variations, the potentiostat may include signaling when the potentiostat is ready to perform testing. In some variations, this may be implemented by restricting receipt of a sample until environmental conditions are satisfied. This could include using some mechanism to control when a sample is introduced to the electrochemical sensing system or restricting access to the reaction region until the environment conditions are satisfied.

[0144] Block S140, which includes analyzing the sample using the sensing electrode system, functions to perform the electrochemical analysis of the sample under controlled environmental conditions. The analysis is preferably performed when and / or while the reaction region is within the targeted environment conditions, which may enhance the reliability of the analysis.

[0145] As one variation, analyzing the sample may include continuously monitoring the augmented environment conditions during electrochemical analysis and dynamically adjusting the environment conditions to maintain predetermined tolerance ranges throughout the electrochemical analysis. This approach maintains environmental stability throughout the entire analysis cycle, including during any reactions or measurements that may affect local environmental conditions.

[0146] Analyzing the sample using the sensing electrode system may include applying a voltage potential between a reference electrode and a counter electrode, reading a reference signal using the reference electrode and counter electrode, applying a voltage potential between the enhanced working electrode and the counter electrode, and reading the sample signal using the enhanced working electrode and the counter electrode.

[0147] This method preferably relies on handling and transformations of a sample enabled through an enhanced working electrode described herein. A sample is preferably supplied to the working electrode, and that sample interacts with the stack of the electrodes so as to filter undesirable particles / molecules and ideally create conditions where a targeted analyte is captured in defined cavities in a way that can be electrochemically measured. As such the method may additionally or alternativelyESEN-M03-PCT include receiving a sample at the hydrogel layer of an enhanced working electrode, filtering the sample through the hydrogel layer into the MIP layer, capturing target molecules of an analyte in the MIP layer, and then applying sensing stimulation through a conductive layer, and determining a quantification of analyte present in the sample.

[0148] Filtering the sample through the hydrogel layer into the MIP layer may include filtering through physically blocking diffusion of a sample through the hydrogel. This functions to block large particles, contaminates, and / or large molecules from moving into the MIP layer. Filtering the sample may additionally or alternatively include chemically filtering. This may include chemically filtering through reacting undesired components of a sample with added molecules in the hydrogel to eliminate interference.

[0149] Determining the quantification of the analyte present in the sample will generally be based on a detected impedance change, which results from an analyte being captured in cavities.

[0150] Other electrochemical sensor types may alternatively use other processing mechanisms when analyzing a sample.4. System Architecture

[0151] The systems and methods of the embodiments can be embodied and / or implemented at least in part as a machine configured to receive a computer-readable medium storing computer-readable instructions. The instructions can be executed by computer-executable components integrated with the application, applet, host, server, network, website, communication service, communication interface, hardware / firmware / software elements of a user computer or mobile device, wristband, smartphone, or any suitable combination thereof. Other systems and methods of the embodiment can be embodied and / or implemented at least in part as a machine configured to receive a computer-readable medium storing computer-readable instructions. The instructions can be executed by computer-executable components integrated with apparatuses and networks of the type described above. The computer- readable medium can be stored on any suitable computer readable media such as RAMs, ROMs, flash memory, EEPROMs, optical devices (CD or DVD), hard drives, floppyESEN-M03-PCT drives, or any suitable device. The computer-executable component can be a processor, but any suitable dedicated hardware device can (alternatively or additionally) execute the instructions.

[0152] In one variation, a system comprising of one or more computer-readable mediums (e.g., non-transitory computer-readable mediums) storing instructions that, when executed by the one or more computer processors, cause a computing platform to perform operations comprising those of the system or method described herein such as: sensing state of environment conditions in a reaction region of a potentiostat device; augmenting the environment conditions in the reaction region of the potentiostat device based on the state of environment conditions; receiving a sample exposed to a sensing electrode system; and analyzing the sample using the sensing electrode system.

[0153] FIGURE 6 is an exemplary computer architecture diagram of one implementation of the system. In some implementations, the system is implemented in a plurality of devices in communication over a communication channel and / or network. In some implementations, the elements of the system are implemented in separate computing devices. In some implementations, two or more of the system elements are implemented in same devices. The system and portions of the system may be integrated into a computing device or system that can serve as or within the system.

[0154] The communication channel 1001 interfaces with the processors 1002A- 1002N, the memory (e.g., a random-access memory (RAM)) 1003, a read only memory (ROM) 1004, a processor-readable storage medium 1005, a display device 1006, a user input device 1007, and a network device 1008. As shown, the computer infrastructure maybe used in connecting electrochemical sensor 1101, environment sensors 1102, environment control modulators 1103, control system 1104, and / or other suitable computing devices.

[0155] The processors 1002A-1002N may take many forms, such CPUs (CentralProcessing Units), GPUs (Graphical Processing Units), microprocessors, ML / DL (Machine Learning / Deep Learning) processing units such as a Tensor Processing Unit, FPGA (Field Programmable Gate Arrays, custom processors, and / or any suitable type of processor.

[0156] The processors 1002A-1002N and the main memory 1003 (or some subcombination) can form a processing unit 1010. In some embodiments, the processingESEN-M03-PCT unit includes one or more processors communicatively coupled to one or more of a RAM, ROM, and machine-readable storage medium; the one or more processors of the processing unit receive instructions stored by the one or more of a RAM, ROM, and machine-readable storage medium via a bus; and the one or more processors execute the received instructions. In some embodiments, the processing unit is an ASIC (Application-Specific Integrated Circuit). In some embodiments, the processing unit is a SoC (System -on-Chip). In some embodiments, the processing unit includes one or more of the elements of the system.

[0157] A network device 1008 may provide one or more wired or wireless interfaces for exchanging data and commands between the system and / or other devices, such as devices of external systems. Such wired and wireless interfaces include, for example, a universal serial bus (USB) interface, Bluetooth interface, Wi-Fi interface, Ethernet interface, near field communication (NFC) interface, and the like.

[0158] Computer and / or Machine-readable executable instructions comprising of configuration for software programs (such as an operating system, application programs, and device drivers) can be stored in the memory 1003 from the processor- readable storage medium 1005, the ROM 1004 or any other data storage system.

[0159] When executed by one or more computer processors, the respective machineexecutable instructions maybe accessed by at least one of processors 1002A-1002N (of a processing unit 1010) via the communication channel 1001, and then executed by at least one of processors 1001A-1001N. Data, databases, data records or other stored forms data created or used by the software programs can also be stored in the memory 1003, and such data is accessed by at least one of processors 1002A-1002N during execution of the machine-executable instructions of the software programs.

[0160] The processor-readable storage medium 1005 is one of (or a combination of two or more of) a hard drive, a flash drive, a DVD, a CD, an optical disk, a floppy disk, a flash storage, a solid-state drive, a ROM, an EEPROM, an electronic circuit, a semiconductor memory device, and the like. The processor-readable storage medium 1005 can include an operating system, software programs, device drivers, and / or other suitable sub-systems or software.

[0161] As used herein, first, second, third, etc. are used to characterize and distinguish various elements, components, regions, layers and / or sections. TheseESEN-M03-PCT elements, components, regions, layers and / or sections should not be limited by these terms. Use of numerical terms maybe used to distinguish one element, component, region, layer and / or section from another element, component, region, layer and / or section. Use of such numerical terms does not imply a sequence or order unless clearly indicated by the context. Such numerical references may be used interchangeable without departing from the teaching of the embodiments and variations herein.

[0162] As a person skilled in the art will recognize from the previous detailed description and from the figures and claims, modifications and changes can be made to the embodiments of the invention without departing from the scope of this invention as defined in the following claims.

Claims

ESEN-M03-PCTCLAIMSWe Claim:

1. A system comprising: a housing defining a defined reaction region; an electrochemical sensor positioned within the reaction region; an environmental control system comprising a thermal control system and a humidity control system positioned to monitor and affect the reaction region; and a controller connected to the electrochemical sensor and the environmental control system.

2. The system of claim i, wherein the environmental control system is positioned to affect environmental conditions within the reaction region, and wherein the housing further defines an electronics section physically separated from the reaction region; and the system further comprising an electric interface through which the electrochemical sensor conductively couples with electronics of the controller.

3. The system of claim 1, wherein the thermal control system is configured to change temperature in the reaction region and comprises a temperature sensor positioned to monitor temperature within the reaction region and a temperature modulator; a humidity control system comprises a humidity sensor positioned to monitor humidity within the reaction region.

4. The system of claim 3, wherein the humidity control system further comprises a humidity modulator.

5. The system of claim 4, wherein the humidity modulator comprises desiccant material positioned for controlled exposure to the reaction region.

6. The system of claim 5, wherein the desiccant material comprises at least one of silica gel, activated charcoal Calcium Chloride, Diethylene Glycol, Calcium Sulfate, and Zeolites, and wherein the system further comprises a heating element configured to regenerate the desiccant material.ESEN-M03-PCT7. The system of claim 4, further comprising a motorized mechanism configured to incrementally adjust desiccant surface area exposure to the reaction region in response to humidity sensor feedback.

8. The system of claim 3, wherein the thermal modulator is a Peltier thermoelectric module.

9. The system of claim 1, further comprising a battery power supply configured to provide electrical power to the environmental control system and the controller.

10. The system of claim 2, wherein the housing comprises thermal insulation material surrounding the reaction region and thermal barriers positioned between the reaction region and external surfaces of the housing.

11. The system of claim 1, wherein the reaction region is dimensioned to contain sample volumes between 10 microliters and 1000 microliters.

12. The system of claim 4, wherein the controller comprises a microcontroller programmed with a feedback control algorithm configured to adjust the thermal modulator and humidity modulator based on readings from the temperature sensor and humidity sensor.

13. The system of claim 12, wherein the controller is programmed with multiple environmental profiles, each profile defining target temperature and humidity conditions for different analysis types.

14. The system of claim 1, wherein the electrochemical sensor comprises: a working electrode comprising a molecular imprinted polymer layer and a hydrogel guard layer; a reference electrode; and a counter electrode.

15. The system of claim 1, wherein the electrochemical sensor comprises 2D-fabricated electrodes including at least a working electrode.

16. The system of claim 1, wherein the electrochemical sensor is integrated into a removable electrode cartridge, and wherein the environmental control system maintains environmental conditions during electrode cartridge replacement.

17. A method comprising: sensing state of environment conditions in a reaction region of a potentiostat device;ESEN-M03-PCT augmenting the environment conditions in the reaction region of the potentiostat device based on the state of environment conditions; receiving a sample exposed to a sensing electrode system; and analyzing the sample using the sensing electrode system.

18. The method of claim 17, wherein sensing state of environment conditions comprises: monitoring temperature within the reaction region using a temperature sensor; and monitoring humidity within the reaction region using a humidity sensor.

19. The method of claim 17, wherein augmenting the environment conditions comprises: controlling temperature within the reaction region using a thermal modulator.

20. The method of claim 19, wherein augmenting the environment conditions further comprises: controlling humidity within the reaction region using a humidity modulator.

21. The method of claim 17, wherein augmenting the environment conditions further comprises: receiving a selection of a sample analysis type; and setting target environmental conditions within the reaction region based on the sample analysis type-22. The method of claim 19, wherein controlling temperature comprises operating a thermal modulator that is a Peltier thermoelectric module.

23. The method of claim 20, wherein controlling humidity comprises: increasing exposure of desiccant material to the reaction region to reduce humidity; and decreasing exposure of desiccant material to the reaction region.

24. The method of claim 23, wherein controlling humidity further comprises: detecting saturation of the desiccant material; and heating the desiccant material to remove absorbed moisture and regenerate the desiccant material.

25. The method of claim 17, wherein receiving a sample comprises: receiving the sample at a microfluidic sample inlet; and transporting the sample to the reaction region through microfluidic channels while maintaining the augmented environment conditions.

26. The method of claim 17, wherein augmenting the environment conditions comprises: establishing target environmental conditions within the reaction region prior to receiving the sample; monitoring achievement of the target environmentalESEN-M03-PCT conditions; and providing a readiness signal when the target environmental conditions are achieved.

27. The method of claim 17, wherein analyzing the sample comprises: continuously monitoring the augmented environment conditions during electrochemical analysis; and dynamically adjusting the environment conditions to maintain predetermined tolerance ranges throughout the electrochemical analysis.

28. The method of claim 17, wherein augmenting the environment conditions comprises using a feedback control algorithm to adjust thermal and humidity modulators based on the sensed state of environment conditions.

29. The method of claim 20, wherein augmenting the environment conditions comprises coordinating thermal control and humidity control to prevent interference between temperature and humidity control operations.

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