CN115004010A - Apparatus, system, and method for measuring solution properties of a sample with a multi-layer active sensor - Google Patents

Abstract

Various devices, systems, and methods are disclosed for measuring solution properties of a sample containing a microorganism. In one embodiment, a sensor device is disclosed, comprising: a sample chamber having a chamber sidewall surrounding a chamber cavity configured to receive a sample; a reference sensor comprising a wicking component that wicks a sample to a reference electrode material; and an active sensor made of a substrate partially covered by an active electrode layer. The active sensor can be coupled to at least a portion of the chamber sidewall at a window opening defined along the chamber sidewall. The active sensor can be positioned such that the active electrode layer faces the chamber cavity to allow a sample within the chamber cavity to make fluid contact with the active electrode layer through at least a portion of the chamber sidewall surrounding the window opening.

Description

Apparatus, system and method for measuring solution properties of a sample with a multi-layer active sensor

Cross Reference to Related Applications

This application claims the benefit of U.S. provisional application No.63/025,575, filed on day 5, 15, 2020, the contents of which are incorporated herein by reference in their entirety.

Technical Field

The present disclosure generally relates to diagnostic devices for measuring solution properties of a sample; and more particularly, to an apparatus, system, and method for measuring solution properties of a sample using a multi-layer active sensor.

Background

Infection by anti-infectious agents (anti-infectious agents) or microorganisms is a significant problem for healthcare professionals in hospitals, nursing homes, and other healthcare environments. For example, such infections may lead to a potentially life-threatening complication known as sepsis, in which the chemicals released into the bloodstream by the infectious agents can trigger dangerous systemic inflammatory and vasoactive reactions, leading to fever, hypotension, and possibly even death. When faced with such infections, a preferred course of action for the clinician is to judiciously use anti-infective compounds, preferably only those compounds necessary to reduce the infection.

However, it is now most often the case that a broad spectrum anti-infective drug, usually a variety of drugs, is administered to a patient to ensure the adequacy of the treatment before the organism is identified and tested for drug sensitivity. This tends to result in multiple drug resistant infectious agents. Ideally, the sensitivity of the infectious agent is detected shortly after its presence is identified. To determine the sensitivity of such infectious agents to anti-infective drugs, samples comprising such infectious agents must be quantified, which requires that such samples be assayed for microbial growth or lack of microbial growth.

Existing biosensors for determining infectious agents and pathogens in biological or other types of samples typically include an active sensing component and a reference sensing component in fluid contact or communication with the sample of interest. Current in vitro diagnostic measurement systems, particularly those used to detect Oxidation Reduction Potential (ORP) and pH in biological or fluid samples, are often not designed with both high performance and low cost in mind. Furthermore, since it is important to prevent cross-contamination of patient samples, single-use disposable consumables are a preferred design for the sensing component of the diagnostic measurement system. This places a great deal of emphasis on the cost and manufacturability of single-use disposable sensing components.

Conventional biosensors are typically manufactured using expensive glass or silicon substrates, which increases the cost of such sensors and requires a large number of manufacturing steps to produce. Furthermore, active sensing components of such biosensors may fail when a biological or other fluid sample inadvertently contacts electrically conductive portions that are not intended to contact active sensing of the sample.

Therefore, a solution is needed that addresses the above-described shortcomings and limitations. Such a solution should be single use and cost effective to manufacture. However, such a solution should also provide accurate measurements and be made of biocompatible materials.

SUMMARY

Devices, systems, and methods for measuring a solution characteristic (e.g., ORP or pH) of a sample including a microorganism are disclosed. In one embodiment, a sensor device for measuring a solution property of a sample is disclosed. The sensor device may comprise a sample container comprising a sample chamber. The sample chamber may include a chamber sidewall surrounding a chamber cavity configured to receive the sample. The sensor device may further include a reference sensor including a reference electrode material and a wick (wick) in fluid communication with the sample chamber. At least some of the sample may be drawn by the wick in the direction of the reference electrode material.

The sensor device may further comprise an active sensor made of a conductive substrate partially covered by an active electrode layer. The active sensor can be coupled to at least a portion of the chamber sidewall at a window opening defined along the chamber sidewall. In some embodiments, no portion of the active sensor extends into the chamber cavity. The active electrode layer can face the chamber cavity to allow a sample within the chamber cavity to be in fluid contact with the active electrode layer through at least a portion of the chamber sidewall surrounding the window opening. When the reference sensor and the active sensor are electrically coupled to the reader device, a solution characteristic of the sample can be determined based on a potential difference measured between the active sensor and the reference sensor.

The measured solution property may be an oxidation-reduction potential. The measured solution property may be pH. The active electrode layer may include at least one of a platinum oxide layer (formed on the platinum layer) and a tantalum oxide layer. The conductive substrate may be stainless steel. The active electrode layer may have an active electrode layer thickness between about 50nm and 500 nm. The active sensor may further comprise an adhesion layer between the conductive substrate and the active electrode layer. The adhesion layer may have a thickness between 5nm and 50 nm. The ratio of the thickness of the adhesion layer to the thickness of the active electrode layer may be between about 1:10 and 1: 20. The adhesion layer may be a chromium layer, a gold layer or a nickel layer.

The active layer may have an active electrode layer thickness of 400 nm. Where the sample container is formed by injection molding, the active sensor may be insert-molded (insert-molded) into the chamber sidewall. After the sample container is formed by injection molding, the active sensor may be press-molded (pressed) into the chamber sidewall. The chamber sidewall can include a recessed portion surrounding the window opening. The recessed portion may be defined along an outer side of the chamber sidewall. The active sensor can be adhered to at least a portion of the chamber sidewall within the recessed portion via an adhesive.

The active sensor may include an active electrode side, a conductive substrate side opposite the active electrode side, and a lateral side. The lateral sides may be covered by at least one of the chamber sidewalls and the adhesive to prevent the lateral sides from contacting the sample. The sample chamber may be made in part of at least one of polyoxymethylene, polyamide, polyethylene, acrylonitrile butadiene styrene, polycarbonate, and polypropylene. The reference electrode material may be a cured or hardened conductive ink deposited or otherwise applied on the wick proximal end of the wick.

In some embodiments, the active sensor may be made of a non-conductive Printed Circuit Board (PCB) substrate partially covered by an electrode layer. The active electrode layer may be electrically coupled to the conductive contact of the PCB substrate by a conductive via extending through the PCB substrate. The PCB substrate may be a flexible PCB substrate.

The PCB substrate may be made in part of polyimide, FR-4 composite, copper, etc. The measured solution property may be an oxidation-reduction potential. The active electrode layer may be a platinum layer or a gold layer. The active electrode layer may have an active electrode layer thickness of at least 50 nm. In certain embodiments, the active electrode layer may have an active electrode layer thickness of at least 400 nm.

In some embodiments, the active sensor may be made of a non-conductive polymer substrate including vias. One side of the polymer substrate and one end of the via hole may be covered by a conductive layer. The active electrode layer may be electrically coupled to the conductive layer via a conductive coating covering the lateral sides of the via.

The active electrode layer may be a platinum layer or a gold layer. The active electrode layer may have an active electrode layer thickness of at least 50 nm. In certain embodiments, the active electrode layer may have an active electrode layer thickness of at least 400 nm.

The active sensor may be a rectangular piece having a width dimension of between about 100 μm to 6.0mm and a length dimension of between about 100 μm to 6.0 mm. The vias may have a diameter between about 10 μm and 100 μm. The conductive coating covering the lateral sides of the via may be a coating of platinum, gold, or the like.

In some embodiments, the active sensor may be made of a conductive pin (dowel) partially covered by an active electrode layer. The active sensor can be coupled to at least a portion of the chamber sidewall at a window opening defined along the chamber sidewall. The portion of the conductive pin covered by the active electrode layer may extend into the chamber cavity to allow a sample within the chamber cavity to be in fluidic contact with the active electrode layer. The end of the conductive pin that does not extend into the chamber cavity may extend out of the chamber sidewall. The conductive pin may be partially made of stainless steel and may be substantially shaped as a cylinder with rounded edges.

A method of measuring a solution property of a sample is also disclosed. The method may include cleaning the conductive substrate with an acid-base treatment, depositing an adhesion layer on one side of the conductive substrate, and depositing an active electrode layer on the adhesion layer. The method can further include singulating (singulating) the conductive substrate covered by the adhesion layer and the active electrode layer to produce an active sensor sized to cover a window opening defined along a chamber sidewall of the sample chamber. The method can further include coupling the active sensor to at least a portion of the chamber sidewall such that no portion of the active sensor extends into the chamber cavity within the sample chamber and the active electrode layer faces the chamber cavity to allow any sample within the chamber cavity to make fluidic contact with the active electrode layer through at least a portion of the chamber sidewall surrounding the window opening.

The method may further include treating the conductive substrate with nitric acid and then treating the conductive substrate with ammonium hydroxide, isopropyl alcohol, or acetone. The method may further include laser cutting, metal shearing, hot wire cutting, dye cutting, stamping or sawing the conductive substrate.

The method can further include applying a bead of adhesive (bead of adhesive) to a portion of the chamber sidewall within a recess defined along the chamber sidewall around the window opening. The method may further include pressing the active sensor onto the bead of adhesive within the recess and curing the adhesive.

The method may further include insert molding the active sensor into the chamber sidewall while forming the sample chamber by injection molding. The method can also include locally melting a portion of the chamber sidewall surrounding the window opening, pressing the active sensor against the melted portion of the chamber sidewall, and allowing the melted portion of the chamber sidewall to cool to secure the active sensor to the chamber sidewall.

The method may further comprise depositing an active electrode material constituting the active electrode layer until the active electrode layer has a thickness of at least 50 nm. In some embodiments, the method may include depositing an active electrode material comprising the active electrode layer until the active electrode layer has a thickness of at least 400 nm. In some embodiments, when the measured solution characteristic is an Oxidation Reduction Potential (ORP) of the sample, the active electrode material may be platinum. The active electrode material may be deposited using sputter deposition, evaporation deposition, electrodeposition, or ink screen printing.

The method may further include depositing an adhesion material comprising the adhesion layer using sputter deposition. The adhesion layer may be deposited in a vacuum chamber and the active electrode layer may be deposited in the same vacuum chamber immediately after the adhesion layer.

When the measured solution property is the pH of the sample, the active electrode material may be a metal oxide. In some embodiments, the metal oxide may be platinum oxide, and the platinum oxide may cover a layer of platinum deposited on the adhesion layer.

In some embodiments, a method of manufacturing a sensor device for measuring solution properties of a sample may include providing a non-conductive Printed Circuit Board (PCB) substrate and depositing an active electrode layer on one side of the PCB substrate. After the depositing step, the active electrode layer may be electrically coupled to the conductive contact of the PCB substrate by a conductive via extending through the PCB substrate. The method may further include singulating the PCB substrate covered by the active electrode layer to produce an active sensor sized to cover a window opening defined along a chamber sidewall of the sample chamber. The active sensor may include at least one conductive via extending through the PCB substrate. The method can further include coupling the active sensor to at least a portion of the chamber sidewall such that no portion of the active sensor extends into the chamber cavity within the sample chamber and the active electrode layer faces the chamber cavity to allow any sample within the chamber cavity to make fluidic contact with the active electrode layer through at least a portion of the chamber sidewall surrounding the window opening.

The method may further include depositing an active electrode material constituting the active electrode layer using sputter deposition, evaporation deposition, and electrodeposition. The active electrode material may be deposited until the active electrode layer has a thickness of at least 50 nm. In some embodiments, the active electrode material may be deposited until the active electrode layer is at least 400nm thick. When the measured solution property is the Oxidation Reduction Potential (ORP) of the sample, the active electrode material may be platinum or gold. The conductive contacts may be made in part of gold.

In some embodiments, another method of making a sensor device can include providing a non-conductive polymer substrate including a plurality of vias, and depositing a conductive layer on one side of the polymer substrate. The method may further comprise depositing an active electrode layer on the other side of the polymer substrate. One end of each of the through holes may be covered with the active electrode layer, and the other end of each of the through holes may be covered with the conductive layer. After the depositing step, the active electrode layer may be electrically coupled to the conductive layer via a conductive coating covering lateral sides of the via. The method may further include singulating the polymer substrate covered by the active electrode layer and the conductive layer to produce an active sensor sized to cover a window opening defined along a chamber sidewall of the sample chamber. The active sensor may comprise at least one via covered by an active electrode layer and a conductive layer.

The method can further include coupling the active sensor to at least a portion of the chamber sidewall such that no portion of the active sensor extends into the chamber cavity within the sample chamber and the active electrode layer faces the chamber cavity to allow any sample within the chamber cavity to make fluidic contact with the active electrode layer through at least a portion of the chamber sidewall surrounding the window opening. Depositing the conductive layer may include depositing a conductive material on the other side of the polymer substrate. In some embodiments, the conductive material may be gold.

Brief Description of Drawings

FIG. 1A illustrates a front view of one embodiment of a sensor device for measuring a solution property of a sample.

FIG. 1B shows a cross-sectional side view of a portion of a sensor device.

Fig. 1C shows a perspective close-up view of an active sensor of a sensor device adhered to a chamber sidewall of the sensor device.

FIG. 1D shows a cross-sectional view of a sensor device filled with a sample.

Fig. 2 shows an embodiment of an active sensor of a sensor device insert molded (insert molding) into a chamber sidewall of the sensor device.

Fig. 3A is a black and white image of a top view of the side of the active sensor covered by the active electrode layer. In this image, the active sensor is molded as part of the chamber sidewall.

Fig. 3B is a black and white image of the opposite side of the active sensor shown in fig. 3A. In this image, the active sensor is molded as part of the chamber sidewall.

FIG. 4A illustrates a perspective view of one embodiment of an active sensor.

FIG. 4B shows a side view of an embodiment of an active sensor for measuring ORP.

Fig. 4C shows a side view of another embodiment of an active sensor for measuring pH.

Fig. 4D shows a side view of another embodiment of an active sensor for measuring pH.

Fig. 5A shows a side view of another embodiment of an active sensor made using a PCB substrate.

Fig. 5B shows a single PCB board covered by an active electrode layer that can be singulated into many individual active sensors.

Fig. 6A is a black and white image showing an active sensor comprising three separate active electrodes.

Fig. 6B is a black and white image showing a close-up view of the contact side of the active sensor shown in fig. 6A.

FIG. 6C is a black and white image showing a single PCB board that can be singulated into many individual active sensors.

Fig. 7 shows a further embodiment of an active sensor made by covering a non-conductive polymer substrate comprising through holes with an active electrode layer and a conductive contact layer.

Fig. 8A and 8B are side cross-sectional views illustrating two different embodiments of active sensors.

Fig. 9 shows a large piece of non-conductive plastic or a large PCB that can be singulated into many active sensors.

Fig. 10 shows a side view of another embodiment of a sensor device comprising an active sensor made of conductive pins.

Fig. 11 is a graph showing the change in oxidation-reduction potential (ORP) of three samples containing escherichia coli (e.coli) measured over time using three different sensors.

FIG. 12 is a graph showing the change in pH of four samples containing different starting concentrations of E.coli measured over time using the sensor device disclosed herein.

Fig. 13A shows a perspective view of a reader device designed to receive a sensor device and determine a solution characteristic of a sample within the sensor device.

Fig. 13B shows a partial cross-sectional view of a reader device with a sample-filled sensor device positioned within the reader device.

Fig. 13C shows a perspective view of a portion of the reader device with the reader housing removed.

Fig. 13D shows a close-up view of a gas nozzle of the reader device attached to the bottom of the sensor device to aerate the sample within the sensor device.

FIG. 14 illustrates one embodiment of a method of manufacturing a sensor device for measuring solution properties of a sample.

FIG. 15 illustrates another embodiment of a method of manufacturing a sensor device for measuring solution properties of a sample.

Fig. 16 shows yet another embodiment of a method of manufacturing a sensor device for measuring a solution property of a sample.

Detailed Description

Variations of the devices, systems, and methods described herein can be best understood from the detailed description when read in conjunction with the accompanying drawings. It is emphasized that, according to common practice, the various features of the drawings may not be drawn to scale. The dimensions of some of the features may have been exaggerated or reduced for clarity, and not all features may be visible or labeled in each drawing. The drawings are for illustrative purposes only and are not intended to limit or restrict the scope of the claims to that shown.

Fig. 1A-1D illustrate an embodiment of a sensor device 100 for measuring a solution property of a sample. In some embodiments, the measured solution characteristic may be an Oxidation Reduction Potential (ORP) of the sample. In other embodiments, the measured solution characteristic may be the pH of the sample.

In some embodiments, the sample may be obtained from a patient or subject. In other embodiments, the sample may be a biological sample, an environmental sample, or a food sample.

When the sample is obtained from a patient or subject, the sample may comprise at least one of a bodily fluid of the patient or subject and a swab obtained from the patient or subject.

In some embodiments, the patient or subject may be a human patient or subject. In other embodiments, the patient or subject may be a non-human animal patient or subject.

In some embodiments, the bodily fluid may include blood, urine, serum, plasma, saliva, sputum, semen, breast milk, joint fluid, spinal fluid such as cerebrospinal fluid, wound material, mucus, fluid associated with stool, vaginal secretions, synovial fluid, pleural fluid, peritoneal fluid, pericardial fluid, amniotic fluid, or combinations thereof.

In these and other embodiments, the swab obtained from the patient or subject may comprise a wound swab, a rectal swab, a vaginal swab, a resuspended example of the foregoing swab, or a combination thereof.

In all such embodiments, the sample may include a number of microorganisms or infectious agents. As part of a microorganism quantification procedure or an Antibiotic Susceptibility Testing (AST) procedure, the devices, systems, and methods disclosed herein can be used to assay a sample for microorganism growth or lack of microorganism growth.

In certain embodiments, the sample may comprise or relate to a bacterial culture extracted from at least one of a sample obtained from a patient or subject, a biological sample, an environmental sample, and a food sample. For example, the sample may comprise or relate to a bacterial culture or a resuspended bacterial culture extracted from a body fluid or swab obtained from a patient or subject. As a more specific example, the sample may comprise a bacterial culture or a resuspended bacterial culture extracted from a bodily fluid or swab obtained from a patient or subject who has tested positive for microbial growth.

More specifically, the sample may comprise a bacterial culture extracted from blood obtained from a patient or subject who has tested positive for microbial growth. In some embodiments, the sample may be or involve a positive blood culture. For the purposes of this disclosure, a positive blood culture may be a bacterial culture extracted from blood drawn from a patient or subject who has been tested positive for bacterial growth. For example, the patient may exhibit sepsisAnd can draw blood (e.g., 5mL to 10mL) from the patient and transfer it to a commercial blood culture container or vessel containing bacterial growth medium (e.g., 30mL to 40mL of growth medium). The blood culture container or vessel may then be incubated at 35 ℃ ± 2 ℃ to allow the bacteria to multiply. If the patient's blood becomes contaminated with bacteria, the bacteria may replicate within the container or vessel. The blood culture system or device can then be used to monitor bacterial growth (such as by monitoring CO of bacteria in the container or vessel) ₂ Generation), and when critical CO has been met ₂ At a threshold, the system or device may determine that the sample is "positive" for the bacterial growth test. Depending on the pathogen type and growth rate, blood cultures can be positive between 7 hours and 3 days. Such "positive blood cultures" may then be used for further downstream testing, such as using any of the devices, systems, and methods disclosed herein.

In additional embodiments, the sample may include environmental samples obtained from streams, rivers, lakes, oceans, contaminated sites, isolated areas, emergency areas, or combinations thereof. In other embodiments, the sample may comprise a food sample obtained from a food preparation facility, a catering facility, a waste treatment facility, or a combination thereof.

In some embodiments, an aqueous growth medium may be added to the sample prior to introducing the sample into the sample container 104 of the sensor device 100. In other embodiments, the aqueous growth medium may be added to the sample once the sample is injected, transported, poured, or otherwise introduced into the sample container 104.

In one example, the aqueous growth medium may be glucose-supplemented Mueller Hinton broth (MHG). In other embodiments, the aqueous growth medium may be a medium containing bacto tryptone, tryptic soy digest, yeast extract, beef extract, cationically-modified Mueller Hinton broth (CAMHB), starch, acid hydrolysate of casein, calcium chloride, magnesium chloride, sodium chloride, blood or lysed blood including Lysed Horse Blood (LHB), CAMHB-LHB, glucose or other carbohydrates, or a combination thereof.

The microorganisms or infectious agents that can be assayed using the devices, methods, and systems disclosed herein can be any metabolic, unicellular or multicellular organism, including bacteria and fungi. In certain embodiments, the microorganism or infectious agent may be a bacterium, including, but not limited to, Acinetobacter (Acinetobacter), Acetobacter (Acetobacter), Actinomyces (Actinomyces), Aerococcus (Aerococcus), Aeromonas (Aeromonas), Agrobacterium (Agrobacterium), Anamorpha (Anaplama), Azorhizobium (Azorhizorhizobium), Azotobacter (Azotobacter), Bacillus (Bacillus), Bacteroides (Bacteroides), Bartonella (Bartonella), Bordetella (Bordetella), Borrelia (Borrelia), Brucella (Brucella), Burkholderia (Burkholderia), Coleobacter (Calymobacterium), Campylobacter (Caylobacter), Chlamydia (Chlamydia), Chlamydia (Chlamydiella), Corynebacterium (Clostridium), Corynebacterium (Corynebacterium), Corynebacterium (Corynebacterium), Corynebacterium (Corynebacterium), Corynebacterium (Corynebacterium), Corynebacterium (Corynebacterium), Corynebacterium (Corynebacterium), Corynebacterium (Corynebacterium) and Escherichia), Corynebacterium (Corynebacterium) may be), Corynebacterium) may be (Corynebacterium) may be used in certain embodiments (Corynebacterium) may be used in (Corynebacterium) may be (Corynebacterium) may be used in the strain (Corynebacterium) may be used in the strain (Corynebacterium) may be used in (Corynebacterium) may be used in the strain (Corynebacterium) may be used in the strain (Corynebacterium) may be used in the strain (Corynebacterium) may be used for example, or the strain (Corynebacterium) may be used in the strain (Corynebacterium) may be used in the strain (Corynebacterium) may be used for the strain (Corynebacterium) may be used in the strain (Corynebacterium) may be used for the strain (Corynebacterium) may be used in, Escherichia (Escherichia), Francisella (Francisella), Clostridium (Fusobacterium), Gardnerella (Gardnerella), Haemophilus (Haemophilus), Helicobacter (Helicobacter), Klebsiella (Klebsiella), Lactobacillus (Lactobacilli), Legionella (Legionella), Listeria (Listeria), Methanobacterium (Methanobacterium), Microbacterium (Microbacterium), Micrococcus (Micrococcus), Morganella (Morganella), Moraxella (Moraxella), Mycobacterium (Mycobacterium), Mycoplasma (Mycoplasma), Neisseria (Neisseria), Pasteurella (Pandora), Bacillus (Paurella), Peptococcus (Peptococcus), Porphyromonas (Porphyromonas), Porphyromonas (Porphyra), Rhizobium (Corynebacterium), Rhizobium (Rhizobium), Rhizobium (Rhizobium) and Rhizobium (Rhizobium) including Rhizobium (Rhizobium) and the genus of the genus Rhizobius (Rhizobius) and the genus of the genus Rhizobiunizobius (Rhizobius) and the genus of the genus Rhizobius (Rhizobius) and the genus of the genus Rhizobiunikontophordeinocerochaelidonnotheizobiunikon) and the genus of, Rickettsia (Rickettsia), rocalima (Rochalimaea), rosmarinus (Rothia), Salmonella (Salmonella), Serratia (Serratia), Shewanella (Shewanella), Shigella (Shigella), Spirillum (Spirillum), Staphylococcus (Staphylococcus), stenotrophomonas (strotrophomonas), Streptococcus (Streptococcus), Streptomyces (Streptomyces), Treponema (Treponema), Vibrio (Vibrio), walbachia (Wolbachia), Yersinia (Yersinia), or combinations thereof. In other embodiments, the microorganism or infectious agent may be one or more fungi selected from Candida (Candida) or Cryptococcus (Cryptococcus) or a mold.

Other specific bacteria that may be assayed using the methods and systems disclosed herein may include Staphylococcus aureus (Staphylococcus aureus), Staphylococcus lugdunensis (Staphylococcus lugdunensis), coagulase-negative Staphylococcus species (including but not limited to Staphylococcus epidermidis (Staphylococcus epidermidis), Staphylococcus haemolyticus (Staphylococcus haemolyticus), Staphylococcus hominis (Staphylococcus hominis), Staphylococcus capitis (Staphylococcus capitis), undifferentiated (not differentiated), Enterococcus faecalis (Enterococcus faecium), Enterococcus faecium (Enterococcus faecium) (including but not limited to Enterococcus faecium (Enterococcus faecium) and species of other Enterococcus species (Enterococcus sp.pneumoniae) not including Enterococcus faecalis), Streptococcus pneumoniae (Streptococcus pneumoniae), Streptococcus pyogenes (Streptococcus pyogenes), Streptococcus pyogenes (Streptococcus pyogenes), Streptococcus pyogenes (Streptococcus pyogenes) species (Streptococcus pyogenes) including but not limited to a species (Streptococcus pyogenes), Streptococcus pyogenes (Streptococcus pyogenes) and Streptococcus pyogenes (Streptococcus pyogenes) species (Streptococcus pyogenes) including but not limited to a, Streptococcus pyogenes (Streptococcus pyogenes), Streptococcus gallic acid (Streptococcus garlulyticus), Streptococcus agalactiae (Streptococcus agalactiae), Streptococcus pneumoniae (Streptococcus pneumaniae), undifferentiated strains of Pseudomonas aeruginosa (Pseudomonas aeruginosa), Acinetobacter baumannii (Acinetobacter baumannii), Klebsiella species (Klebsiella spp.) (including but not limited to Klebsiella pneumoniae (Klebsiella pneumoniae), Klebsiella oxytoca (Isaria oxydytococcus), undifferentiated strains of Escherichia coli (Escherichia coli), Enterobacter species (Enterobacter spp.) (including but not limited to Enterobacter cloacae (Enterobacter cloacae), Enterobacter Enterobacter (Enterobacter coli), proteobacter species (Corynebacterium Proteus), heterologous strains of Enterobacter (Corynebacterium glutamicum), heterologous strains of Escherichia coli (Corynebacterium glutamicum), heterologous strains of Corynebacterium glutamicum (Corynebacterium glutamicum), heterologous strains of Escherichia coli (Lactobacillus strains), heterologous strains of Escherichia coli (Lactobacillus), including but not limited to Clostridium (Corynebacterium), heterologous strains of Escherichia coli (Corynebacterium), Lactobacillus strain (Corynebacterium strain (Escherichia coli), heterologous strains of Escherichia coli (Corynebacterium strain (Corynebacterium), preferably strain (Corynebacterium strain), Pseudomonas aeruginosa), Pseudomonas strain (Corynebacterium strain), Pseudomonas strain (Corynebacterium strain), strain (Corynebacterium strain), strain (Corynebacterium strain), strain (Corynebacterium strain), strain (Corynebacterium strain), strain, Corynebacterium strain, Citrobacter kefir (Citrobacter koseri), Serratia marcescens (Serratia marcescens), Candida albicans (Candida albicans), Candida glabrata (Candida glabrata), and Candida tropicalis (Candida tropicalis).

Other more specific bacteria that may be detected may include, among others, Acinetobacter baumannii, Actinomyces spp, Actinomycetes, Actinomyces spp, including but not limited to Actinomyces israelii and Actinomyces naeslundii, Aeromonas spp, including but not limited to Aeromonas hydrophila, Aeromonas hydrophila temperate organism variant (Aeromonas veronii) and Aeromonas caviae (Aeromonas caviae), Aeromonas caviae, Bacillus subtilis, Actinomyces oxydans, Bacillus cereus, Bacillus cere, Bacillus thuringiensis (Bacillus thuringiensis) and Bacillus stearothermophilus (Bacillus stearothermophilus)), Bacteroides species (Bacteroides spp), including but not limited to Bacteroides fragilis (Bacillus fragilis), Bartonella species (Bartonella spp), including but not limited to Bartonella bacilliform (Bartonella bacilliformis) and Bartonella henselae (Bartonella henselae), Bifidobacterium species (Bifidobacterium spp), Bordetella spp (Bordetella pertussis spp), including but not limited to Bordetella pertussis (Bordetella pertussis persica), Bordetella parapertussis (Bordetella parvulus), and Bordetella bronchiseptica (Bordetella pyrenoidocella), Bordetella bronchiseptica species (Bordetella pyrenoidosa) including but not limited to Bordetella pyrrosia (Bordetella pyrrosia) and Bordetella bronchiseptica), Bordetella bronchiseptica species (Bordetella pyrrosia) including but not limited to Bordetella pyrrosia (Bordetella abortus), Bordetella pyrrosia species (Bordetella) and Bordetella pyrrosia (Bordetella) including but not limited to Bordetella) including but to Bordetella species (Bordetella) and Bordetella species (Bordetella) including but not limited to Bordetella species (Bordetella) and Bordetella pyrrosia) including but to Bordetella species (Bordetella) and Bordetella strain (Bordetella) including Bordetella species (Bordetella) including but including Bordetella) including Bordetella species (Bordetella) and Bordetella spp Brucella (Brucella canis), Brucella melitensis (Brucella melitensis) and Brucella suis (Brucella suis)), Burkholderia species (Burkholderia spp), including but not limited to Burkholderia rhinoides (Burkholderia pseudomallei) and Burkholderia cepacia (Burkholderia cepacia), Campylobacter species (Campylobacter spp), including but not limited to Campylobacter jejuni (Campylobacter jejuni), Campylobacter coli (Campylobacter coli), Campylobacter marini (Campylobacter sphaericus) and Campylobacter fetus (Campylobacter sphaericus), carbon dioxide cellulophilus species (Campylobacter sphaericus), Corynebacterium parvum (Corynebacterium parvum), Corynebacterium parvum (Corynebacterium parvum) and Corynebacterium parvum (Corynebacterium parvum) species (Corynebacterium parvum) and Corynebacterium parvum (Corynebacterium parvum) including but not limited to Corynebacterium parvum (Corynebacterium parvum) and Corynebacterium parvum (Corynebacterium parvum) and Corynebacterium parvum (Corynebacterium parvum) of the strain (Corynebacterium parvum) are included in the strain (Corynebacterium parvum) and Corynebacterium parvum (Corynebacterium parvum) of the strains), and Corynebacterium parvum (Corynebacterium parvum) of the strain (Corynebacterium parvum) including but not included in the strain (Corynebacterium parvum) and Corynebacterium parvum of the strain (Corynebacterium parvum) of the strain (Corynebacterium parvum) and Corynebacterium parvum (Corynebacterium parvum) of the strain (Corynebacterium parvum) including but not included in the strain (Corynebacterium parvum) and Corynebacterium parvum (Corynebacterium parvum) of the strain (Corynebacterium parvum) and Corynebacterium parvum (Corynebacterium parvum) including but not included in the strain (Corynebacterium parvum) and Corynebacterium parvum) of the strain (Corynebacterium parvum, Corynebacterium jejunum (Corynebacterium jeikeum) and Corynebacterium), Clostridium species (Clostridium spp), including but not limited to Clostridium perfringens (Clostridium perfringens), Clostridium difficile (Clostridium difficile), Clostridium botulinum (Clostridium botuli) and Clostridium tetani (Clostridium tetani), Enterobacter erosive (Eikenera corrigens), Enterobacter species (Enterobacter spp), including but not limited to Enterobacter aerogenes (Enterobacter aerogenes), Enterobacter agglomerans (Enterobacter agglomerans), Enterobacter cloacae (Enterobacter cloacae) and Escherichia coli (Enterobacter coli), including but not limited to Enterobacter enterogenes, including but not limited to Enterobacter enterotoxigenic Escherichia coli, Enterobacter urocortis, Escherichia coli, Enterobacter Enterobacter coli and Enterobacter hemorrhagic, Enterobacter Enterobacter coli (Enterobacter faecalis) including but not limited to Enterobacter faecalis strain Escherichia coli, Enterobacter Enterobacter coli and Enterococcus), Enterobacter Enterobacter pathogenic strains (Enterobacter faecalis) including but not limited to Escherichia coli, Species of erichiaceae (Ehrlichia spp.) (including but not limited to the erigeron philippinensis (Ehrlichia chafeensis) and Ehrlichia caninum (Ehrlichia canis)), Erysipelothrix rhusiopathiae (erysiphora rhusiopathiae), species of Eubacterium (Eubacterium spp.), frangula thermofusiforme (Francisella tularensis), Fusobacterium nucleatum (Fusobacterium nucleatum), Gardnerella vaginalis (Gardnerella vagarilis), geminula measles (Gemella morbifida), species of Haemophilus (Haemophilus spp.) (including but not limited to the Haemophilus influenzae (Haemophilus influenzae), Haemophilus ducreyi (Haemophilus), Haemophilus influenzae (Haemophilus influenzae), Haemophilus parahaemophilus (Haemophilus), Haemophilus parahaemophilus (Haemophilus), Haemophilus parahaemophilus Haemophilus Helicobacter pylori (Haemophilus), Haemophilus parahaemophilus (Haemophilus), Haemophilus (Haemophilus), Haemophilus parahaemophilus (Haemophilus), and Haemophilus (Haemophilus), Haemophilus), Haemophilus parahaemophilus Haemophilus (Haemophilus) and Haemophilus (Haemophilus) including but not limited to the species of Haemophilus spp (Haemophilus spp (Haemophilus) and Haemophilus) and Haemophilus) including but to the same strain (Haemophilus) and Haemophilus) including but to (Haemophilus) and Haemophilus) and Haemophilus) including but to (Haemophilus) including but to be a (Haemophilus haemophil, Kingella kingii, species of Klebsiella (Klebsiella spp.), including but not limited to Klebsiella pneumoniae (Klebsiella pneumoniae), Klebsiella granulomatosa (Klebsiella grandis) and Klebsiella oxytoca (Klebsiella oxytoca)), species of Lactobacillus (Lactobacillus spp.), Listeria monocytogenes (Listeria monocytogenes), Leptospira (Leptospira internograns), Legionella pneumophila (Leptospira nigra), Leptospira (Leptospira nigra), Streptococcus (Peptospira streptococci) (Peptospira brassicae), Moraxella (Moraxella tarrhalis), species of Rhizopus (Moraxella sp), Mycobacterium (Mycobacterium spp), Mycobacterium (Mycobacterium tuberculosis (Mycobacterium spp), Mycobacterium tuberculosis (Mycobacterium tuberculosis), Mycobacterium (Mycobacterium tuberculosis (Mycobacterium spp), Mycobacterium tuberculosis (Mycobacterium tuberculosis strain (Mycobacterium), Mycobacterium (Mycobacterium tuberculosis strain (Mycobacterium), Mycobacterium tuberculosis strain (Mycobacterium) including but not limited to Mycobacterium), Mycobacterium (Mycobacterium tuberculosis strain (Mycobacterium), Mycobacterium tuberculosis strain (Mycobacterium) and Mycobacterium (Mycobacterium tuberculosis strain (Mycobacterium) including but not limited to Mycobacterium), Mycobacterium (Mycobacterium tuberculosis strain (Mycobacterium), Mycobacterium tuberculosis strain (Mycobacterium) and Mycobacterium tuberculosis strain (Mycobacterium) including Mycobacterium tuberculosis strain (Mycobacterium) and strain (Mycobacterium tuberculosis strain (Mycobacterium) and strain (Mycobacterium tuberculosis) including Mycobacterium tuberculosis strain (Mycobacterium) and strain (Mycobacterium tuberculosis strain (Mycobacterium) and strain (Mycobacterium tuberculosis strain (Mycobacterium) including Mycobacterium) and strain (Mycobacterium tuberculosis strain (Mycobacterium) and strain of the like, Mycobacterium bovis (Mycobacterium bovis) and Mycobacterium marinum (Mycobacterium marinum)), species of Mycoplasma (Mycoplasma spp), including but not limited to Mycoplasma pneumoniae (Mycoplasma pneoniae), Mycoplasma hominis (Mycoplasma hominis) and Mycoplasma genitalium (Mycoplasma gentialis), species of Nocardia (Nocardia spp)), including but not limited to Nocardia asteroides, Nocardia cyrigoriogrica and Nocardia bracteata (Nocardia brasiliensis), species of Neisseria (Neisseria spp), including but not limited to Neisseria gonorrhoeae (Neisseria gonorrhoea) and Neisseria meningitidis (Neisseria gonorrhoeae), Mycobacterium Pasteurella (Paotella), species of Porphyromonas (Porphyromonas), species of Mycoplasma Proteus (Porphyromonas), species of Porphyromonas (Porphyromonas), species of Porphyra spp), species of Porphyromonas (Porphyromonas), and Porphyromonas (Porphyromonas) including but not limited to Porphyromonas (Porphyromonas), species of Neisseria monocytogenes (Porphyromonas), Porphyromonas (Porphyromonas) and strains), and strains, Porphyromonas (Porphyromonas) including but also included in the genus), and strains, Porphyromonas (Porphyromonas) and strains), and strains, Porphyromonas (Porphyromonas) including but not included in, Porphyromonas) including but including strains), Mycoplasma purpurea) and strains, Porphyromonas (Porphyromonas) and Mycoplasma spp), Mycoplanaria) and Mycoplasma spp), Mycoplasma spp) Providencia species (Providencia spp.) (including but not limited to Providencia alcaligenes (Providencia alkalilafaciens), Providencia reuteri (Providencia rettgeri) and Providencia sidaceae (Providencia sturtii)), Pseudomonas aeruginosa (Pseudomonas aeruginosa), Propionibacterium acnes (Propionibacterium acnes), Rhodococcus equi (Rhodococcus equi), Rickettsia species (Rickettsia spp.) (including but not limited to Rickettsia rickettsii (Rickettsia rickettsii), Microscotis arachnoides (Rickettsia rickettsii), Salmonella rickettsiae (Rickettsia rickettsii), Salmonella rickettsii (Rickettsia sarkensi), Salmonella typhimurii (Rickettsia) and Salmonella typhimurialis) including but not limited to Salmonella enterica (Rickettsia typhimuriella typhimurium), Salmonella typhimurium (Rickettsia sp.), Salmonella typhimurium) and Salmonella typhimurialis (Ricken) including but not limited to Salmonella typhimuriella typhimurialis (Rickenella typhimurium) and Salmonella typhimurium sp Salmonella paratyphi (Salmonella paratyphi), Salmonella enteritidis (Salmonella enteritidis), Salmonella choleraesuis (Salmonella choleraesuis) and Salmonella typhimurium (Salmonella typhimurium), Serratia spp (including but not limited to Serratia marcescens (Serratia mares) and Serratia liquefaciens (Serratia liquiensis)), Shigella spp (including but not limited to Shigella dysenteriae (Shigella dysenteriae), Shigella flexneri (Shigella flexneri), Shigella boydii (Shigella boydii) and Shigella sonnei (Shigella sonnei), Staphylococcus spp (including but not limited to Staphylococcus aureus serotype Staphylococcus epidermidis, Staphylococcus epidermidis (Staphylococcus epidermidis), Staphylococcus pneumoniae (Staphylococcus epidermidis) such as Streptococcus pneumoniae (Streptococcus pneumoniae), Streptococcus pneumoniae (Streptococcus pneumoniae) including but not limited to Streptococcus pneumoniae B), Staphylococcus pneumoniae (Streptococcus pneumoniae, Streptococcus pyogenes (Streptococcus pyogenes), Streptococcus pneumoniae, Streptococcus pneumoniae, Streptococcus, and Streptococcus pneumoniae, Streptomycin-resistant serotype 9V Streptococcus pneumoniae, erythromycin-resistant serotype 14 Streptococcus pneumoniae, alprotoxin-resistant serotype 14 Streptococcus pneumoniae, rifampin-resistant serotype 18C Streptococcus pneumoniae, tetracycline-resistant serotype 19F Streptococcus pneumoniae, penicillin-resistant serotype 19F Streptococcus pneumoniae, and trimethoprim-resistant serotype 23F Streptococcus pneumoniae, chloramphenicol-resistant serotype 4 Streptococcus pneumoniae, spectinomycin-resistant serotype 6B Streptococcus pneumoniae, streptomycin-resistant serotype 9V Streptococcus pneumoniae, alprotoxin-resistant serotype 14 Streptococcus pneumoniae, rifampin-resistant serotype 18C Streptococcus pneumoniae, penicillin-resistant serotype 19F Streptococcus pneumoniae, or trimethoprim-resistant serotype 23F Streptococcus pneumoniae), Streptococcus agalactiae (Streptococcus mutans), Streptococcus mutans (Streptococcus mutans), Streptococcus pyogenes (Streptococcus pyogenes), group a Streptococcus, Streptococcus pyogenes (Streptococcus pyogenes), group B Streptococcus, Streptococcus agalactiae (Streptococcus agalactiae), group C Streptococcus, Streptococcus pharyngis (Streptococcus angularis), group G Streptococcus (Streptococcus equillis), group D Streptococcus, Streptococcus bovis (Streptococcus bovis), group F Streptococcus, Streptococcus pharyngis (Streptococcus angularis), and group G Streptococcus), Spirospira parvum (Spirillum minutum), Streptococcus moniliforme (Streptococcus moniliformis), species of Treponema sp (Treponema sp.), Treponema peterum, Treponema pallidum (Treponema pallidum) and Vibrio parapolybdenum, Treponema pertenum (Treponema pallidum), Vibrio parahaemolyticus (Vibrio Vibrio parahaemolyticus), Vibrio parahaemolyticus (Vibrio parahaemolyticus), Vibrio parahaemolyticus Vibrio (Vibrio parahaemolyticus), Vibrio parahaemolyticus sp, Vibrio parahaemolyticus (Vibrio Vibrio parahaemolyticus), Vibrio parahaemolyticus (Vibrio Vibrio parahaemolyticus), Vibrio parahaemolyticus (Vibrio), Vibrio parahaemolyticus (Vibrio parahaemolyticus), Vibrio haemolyticus), Vibrio parahaemolyticus (Vibrio, Vibrio parahaemolyticus), Vibrio parahaemolyticus (Vibrio parahaemolyticus, Vibrio parahaemolyticus, Vibrio haemolyticus, Vibrio parahaemolyticus, Vibrio haemolyticus, Vibrio parahaemolyticus, Vibrio haemolyticus, Vibrio haemolyticus, Vibrio parahaemolyticus, Vibrio haemolyticus, Vibrio parahaemolyticus, Vibrio haemolyticus, Vibrio haemolyticus, Vibrio haemolyticus, Vibrio, Vibrio vulnificus (Vibrio vulgaris), Vibrio alginolyticus (Vibrio alginilyticus), Vibrio mimicus (Vibrio mimicus), Vibrio hollisae (Vibrio hollisae), Vibrio fluvialis (Vibrio fluvialis), Vibrio metschnikovii (Vibrio metchnikovii), Vibrio marini (Vibrio damsela) and Vibrio furysii), Yersinia species (Yersinia spp.) (including but not limited to Yersinia enterocolitica (Yersinia enterolytica), Yersinia pestis (Yersinia pestis) and Yersinia pseudotuberculosis (Yersinia eusporum)) and Xanthomonas maltophilia (Xanthomonas maltophilia).

In addition, other microorganisms or infectious agents that may be assayed using the methods and systems disclosed herein may include fungi or molds, including, but not limited to, species of Candida (Candida spp), including but not limited to Candida albicans, Candida glabrata (Candida glabrata), Candida tropicalis (Candida tropicalis), Candida parapsilosis (Candida parapsilosis), and Candida krusei (Candida krusei), species of Aspergillus (Aspergillus spp), including but not limited to Aspergillus fumigatus, Aspergillus flavus (Aspergillus flavus), Aspergillus clavatus (Aspergillus clavatus), species of Cryptococcus (Cryptococcus spp), including but not limited to Cryptococcus neoformans (Cryptococcus neoformans), Candida carotovora (Cryptococcus glaucoides), Cryptococcus neoformans (Cryptococcus sp), and species of Cryptococcus (Cryptococcus sp), including but not limited to, Candida albicans (Cryptococcus sp), Candida sp), and Candida sp Fusarium solani (Fusarium solani), Fusarium verticillium (Fusarium verticillioides) and Fusarium exserotinate (Fusarium proliferatum), Rhizopus oryzae (Rhizopus oryzae), Penicillium marneffei (Penicillium marneffei), Coccidioides immitis and Blastomyces dermatitidis (Blastomyces dermatitidis).

FIG. 1A illustrates a front view of one embodiment of a sensor device 100 for measuring a solution property of a sample. Sensor device 100 can include a sample container 104, the sample container 104 including a sample chamber 108, a reference sensor 122 fabricated as part of a container cap 116 (see, e.g., fig. 1D), and an active sensor 106 coupled to at least a portion of the sample chamber 108. The container cap 116 may be removably or detachably coupled or secured to the sample container 104 (e.g., screwed or pressed onto the top of the sample container 104).

The sample container 104 may be partially made of an inert or non-conductive material. In some embodiments, the sample container 104 may comprise or be partially made of a polymeric material, a ceramic material, or glass, or a combination thereof. As more specific examples, the sample container 104 may include or be partially made of polyvinyl chloride (PVC), poly (methyl methacrylate) (PMMA), Polydimethylsiloxane (PDMS), or a combination thereof.

FIG. 1B shows a cross-sectional side view of a portion of sensor device 100. Fig. 1B shows that sample chamber 108 may include a chamber sidewall 112 surrounding a chamber cavity 109 configured to receive a sample. Active sensor 106 can be affixed, adhered, or otherwise coupled to chamber sidewall 112 of sample container 104. In other embodiments not shown in the figures, the active sensor 106 may be coupled to the bottom of the sample container 104 or otherwise positioned along the bottom of the sample container 104.

Active sensor 106 can be coupled to at least a portion of chamber sidewall 112 at a window opening 114 defined along chamber sidewall 112. Chamber sidewall 112 can include a recessed portion 134 surrounding window opening 114. Recessed portion 134 may be defined along an exterior side of chamber sidewall 112.

With respect to the placement of the active sensor 106, as seen in fig. 1C, the active sensor 106 may be configured such that no portion of the active sensor 106 extends into the chamber cavity 109.

As will be discussed in more detail in the following sections, the active sensor 106 may be made of a conductive substrate partially covered by an active electrode layer 132. Active electrode layer 132 of active sensor 106 can face chamber cavity 109 to allow a sample within chamber cavity 109 to be in fluid contact with active electrode layer 132 through at least a portion of chamber sidewall 112 surrounding window opening 114.

Fig. 1C shows a perspective close-up view of active sensor 106 adhered to chamber sidewall 112. In the embodiment shown in fig. 1C, active sensor 106 is adhered to recessed portion 134 of chamber sidewall 112. At least a portion of active electrode layer 132 of active sensor 106 may cover window opening 114 defined along chamber sidewall 112 such that the portion of active electrode layer 132 covering window opening 114 is positioned in fluid communication with chamber cavity 109 of sample chamber 108. When sample chamber 108 is filled with a sample, the sample may be in fluid contact with the portion of active electrode layer 132 that covers window opening 114.

Fig. 1C also shows that the active sensor 106 may have its lateral sides covered by adhesive 138. Because active sensor 106 may include multiple layers, adhesive 138 may protect certain layers of active sensor 106 from undesired contact with the fluid sample. Adhesive 138 may act as a barrier to prevent the fluid sample from contacting lateral sides 136 of active sensor 106. In other embodiments not shown in the figures but contemplated by the invention, recessed portion 134 of chamber sidewall 112 can be sized such that active sensor 106 fits snugly within recessed portion 134, and the walls of recessed portion 134 abut or confine lateral side 136 of active sensor 106. This may ensure that only the exposed portion of the active electrode layer 132 is in contact with the fluid sample, resulting in a more accurate measurement of the solution properties of the fluid sample.

To adhere active sensor 106 to sample chamber 108, bead of adhesive 138 may be applied to inner rim 140 and/or side margins 142 of recess 134, and active sensor 106 may then be pressed into recess 134 with an end effector of a pick and place machine. Active sensor 106 can be pressed or otherwise pushed into recess 134 until the exterior facing surface of active sensor 106 is flush with the exterior surface of chamber sidewall 112.

The adhesive 138 may then be cured to secure the active sensor 106 in place. In some embodiments, the adhesive 138 may be a medical grade UV curable adhesive. For example, the adhesive 138 may be

1405M-T-UR-SC adhesive (which can be cured using LED light having a wavelength of about 405 nm). In other embodiments, the adhesive 138 may be any low outgassing medical grade adhesive.

As previously mentioned, the active sensor 106 may be made of a conductive substrate partially covered by the active electrode layer 132. The active sensor 106 can be positioned such that the active electrode layer 132 faces the chamber cavity 109 to allow a sample within the chamber cavity 109 to be in fluid contact with the active electrode layer 132 through at least a portion of the chamber sidewall 112 surrounding the window opening 114. In this embodiment, active sensor 106 (including active electrode layer 132) is positioned radially outward from the interior-facing or cavity-facing side of chamber sidewall 112, and lateral side 136 of active sensor 106 is not exposed to the fluid sample.

In some embodiments, the measured or monitored solution characteristic may be the pH of the sample. When the measured or monitored solution characteristic is pH, the active electrode layer 132 may be a pH sensitive material. For example, the pH sensitive material may be or include silicon dioxide (SiO) ₂ ) Alumina (Al) ₂ O ₃ ) Titanium dioxide (TiO) ₂ ) Tantalum oxide/tantalum pentoxide (Ta) ₂ O ₅ ) Hafnium oxide (HfO) ₂ ) Iridium dioxide (IrO) ₂ ) Ruthenium dioxide (RuO) ₂ ) Zirconium dioxide (ZrO) ₂ ) Any one of, or a combination thereof.

In these and other embodiments, the measured or monitored solution characteristic may be an Oxidation Reduction Potential (ORP) of the sample. When the solution property being measured or monitored is the ORP of the sample, active electrode layer 132 may be a redox sensitive material. For example, the redox-sensitive material may be or include any one of platinum (Pt), gold (Au), redox-sensitive metal oxides, or combinations thereof. More specifically, the redox-sensitive material may be or include silicon dioxide (SiO) ₂ ) Alumina (Al) ₂ O ₃ ) Titanium dioxide (TiO) ₂ ) Tantalum pentoxide (Ta) ₂ O ₅ ) Hafnium oxide (HfO) ₂ ) Iridium dioxide (IrO) ₂ ) And (2) oxidation ofRuthenium (RuO) ₂ ) Zirconium dioxide (ZrO) ₂ ) Any one of, or a combination thereof. The fabrication of the active sensor 106 will be discussed in more detail in later sections.

Although not shown in the figures, the present invention contemplates that sensor device 100 can be designed such that both the pH and ORP of the sample are measured simultaneously. For example, sample chamber 108 of sensor device 100 may include a plurality of window openings 114 defined along chamber sidewalls 112 of sample chamber 108. Each of these window openings 114 may then be covered by a different active sensor 106 (e.g., one window opening 114 may be covered by an active sensor 106 having an active electrode layer 132 made of a redox sensitive material, while another window opening 114 may be covered by an active sensor 106 having an active electrode layer 132 made of a pH sensitive material).

The sensor device 100 may have a device height. In some embodiments, the device height may be between about 20.0mm to about 50.0 mm. In other embodiments, the device height may be between about 25.0mm to about 35.0 mm. For example, the device height may be about 31.3 mm.

FIG. 1D illustrates that the reference sensor 122 may be fabricated as part of the container cap 116. The reference sensor 122 may include a reference catheter 118, the reference catheter 118 including a reference catheter lumen 120 (see, e.g., fig. 1B). The reference catheter lumen 120 may have a first opening and a second opening at opposite ends of the reference catheter lumen 120. The reference conduit 118 may be an elongated channel or passage configured to extend into the chamber 109 of the sample chamber 108.

The reference sensor 122 can also include a reference electrode material 149 and a wicking member 150 in fluid communication with the chamber 109. The reference catheter lumen 120 can house a wicking member 150. At least some of the sample may be drawn by the wicking member 150 in the direction of the reference electrode material 149.

The reference catheter 118 can be tapered such that the volume of the reference catheter lumen 120 tapers or narrows from the reference catheter proximal end 126 to the reference catheter distal end 128 (see, e.g., fig. 1B). The shape of the wicking member 150 may match or accommodate the shape of the reference catheter lumen 120. The wicking member 150 is configured such that the shape of the wicking member 150 tapers or narrows from the wick proximal end 152 to the wick distal end 154.

The wicking member 150 may extend through the length of the reference catheter lumen 120. In some embodiments, the wicking member 150 may fill or occupy all of the space within the reference catheter lumen 120. In other embodiments, the wicking member 150 may partially fill or partially occupy the space within the reference catheter lumen 120.

At least a portion of the wicking member 150 may be in fluid communication with the chamber 109 of the sample chamber 108 such that when the sample chamber 108 is filled with a sample, at least some of the sample in the sample chamber 108 is wicked, absorbed, or otherwise wicked by at least a portion of the wick distal end 154 in the direction of the wick proximal end 152. The wicking member 150 may be made of a polymeric material that draws the fluid sample by capillary action toward the reference electrode material 149.

In some embodiments, at least a portion of the wick distal end 154 may extend through the reference conduit second opening such that the wick distal end 154 protrudes or extends into the chamber cavity 109 of the sample chamber 108. In these embodiments, the wick distal end 154 may extend or protrude into the sample when the sample chamber 108 is filled with the sample.

In other embodiments, the wick distal end 154 is positioned near or above the reference conduit second opening such that the wick distal end 154 does not protrude or extend into the chamber cavity 109 of the sample chamber 108. In these embodiments, the wick distal end 154 may still be in fluid communication with the sample chamber 108, and the fluid sample may still reach or contact the wick distal end 154 by being drawn into the reference conduit 118 by capillary action or by disturbing or shaking the sample container 104.

As previously mentioned, the wicking member 150 may be partially made of a porous material. The wicking member 150 may be made in part of a material that includes pores between 15 μm to about 150 μm in size (e.g., about 50 μm). In some embodiments, wicking member 150 may be partially made of a polymeric material. As a more specific example, the wicking member 150 may be made of a porous polymeric material that includes pores between 15 μm to about 150 μm in size. In one embodiment, the wicking member 150 may be made in part of High Density Polyethylene (HDPE). For example, the wicking member 150 may be made in part from HDPE with pores having a size of about 50 μm. In other embodiments, wicking member 150 may be made in part from natural fibers. For example, the wicking member 150 may be made in part from cellulose fibers, pulp, paper, cotton, or a combination thereof.

The wicking member 150 may also be treated with a surfactant such that at least the surface of the wicking member 150 is covered with the surfactant. In some embodiments, the wicking member 150 may be saturated or immersed in a surfactant-containing solution prior to being introduced into the reference catheter lumen 120. The surfactant may be configured to increase the hydrophilicity of the wicking member 150 (i.e., make the substantially hydrophobic surface of the wicking member 150 more hydrophilic). In some embodiments, the surfactant may be a fluorosurfactant. In other examples, the surfactant may be a non-ionic surfactant, such as one or more poloxamers (poloxamers). As a more specific example, the surfactant may include

F-68。

In one embodiment, the reference catheter 118 may be substantially shaped as a cone or a frustum of a cone with a reference catheter lumen 120 that is also substantially shaped as a cone or a frustum of a cone. In other embodiments, the reference conduit 118 may be substantially shaped as an elongated pyramid having a polygonal base. For example, the reference conduit 118 may be substantially shaped as an elongated triangular pyramid, a square pyramid, or a pentagonal pyramid. In further embodiments, the reference catheter 118 may be substantially shaped as a cylinder with a substantially cylindrical reference catheter lumen 120. In these embodiments, the reference catheter 118 may have a tapered reference catheter distal end 128 (see, e.g., fig. 1B).

As shown in fig. 1D, at least a portion of wicking member 150 may be in contact with the sample fluid in sample chamber 108. At least some of the sample may be drawn by the wicking member 150 in the direction of the wicking proximal end 152. A reference electrode material 149 may be disposed at the wick proximal end 152. FIG. 1D also shows that at least a portion of active electrode layer 132 may be in contact with a sample fluid in sample chamber 108. As the wicking member 150 wicks or wicks the sample, the sample can reach the reference electrode material 149 and charge carriers in the sample can establish an electrical connection between the reference electrode material 149 of the reference sensor 122 and the active electrode layer 132 of the active sensor 106. When both the reference sensor 122 and the active sensor 106 are electrically coupled to the reader device 190, the reader device 190 can be used to measure solution characteristics of the sample.

When the reference sensor 122 and the active sensor 106 are electrically coupled to the reader device 190, the solution characteristics of the sample can be determined based on the potential difference measured between the active sensor 106 and the reference sensor 122. For example, when reference electrode material 149 and active electrode layer 132 are both in contact with a sample fluid within sample chamber 108, reference sensor 122 can provide a stable half-cell potential compared to active sensor 106.

In some embodiments, the reference electrode material 149 may be a conductive ink applied or dispensed on the wick proximal end 152. The conductive ink applied or dispensed on the wick proximal end 152 may be hardened by curing. More specifically, the conductive ink may be silver-silver chloride (Ag-AgCl) ink.

At least a portion of the reference electrode material 149 may be coupled to the wicking member 150. For example, the reference electrode material 149 may be a solidified and hardened mass positioned at the wick proximal end 152. In certain embodiments, the reference electrode material 149 may be positioned in the middle of the vessel cap 116. In some embodiments, at least a portion of the reference electrode material 149 may protrude or extend beyond the vessel cap 116.

One advantage of the wicking member 150 disclosed herein is that the wicking member 150 can draw up the sample, and the sample can advance by capillary action through the pores of the wicking member 150 toward the reference electrode material 149. For example, the fluid sample may be wicked to the wick proximal end 152 where it comes into fluid contact with the reference electrode material 149. When the reference electrode material 149 is made of a material such as silver-silver chloride (Ag-AgCl)When formed, the wicking member 150 may function as silver ion (Ag) ⁺ ) A barrier or impediment to silver ions that would otherwise freely diffuse into the sample within sample chamber 108. Such silver ions may be detrimental to or otherwise affect the growth of microorganisms or infectious agents in the sample. Wicking member 150 may be used as a barrier or impediment to unwanted silver ions by slowing or preventing their diffusion into the sample. Wicking members 150 having the size and shape disclosed herein may be effective in slowing or preventing the diffusion of such harmful ions.

When the reference sensor 122 is implemented as the vessel cap 116, the vessel cap 116 may have dimensions defined by a cap width (or diameter) and a cap height. In some embodiments, the cap width may be between about 10.0mm to about 20.0 mm. For example, the cap width may be about 15.7 mm. In some embodiments, the cap height may be between about 5.0mm to about 20.0 mm. For example, the cap height may be about 10.5 mm. When the container cap 116 is secured, or otherwise coupled to the sample container 104, the sensor device 100 may have a device height measured from the bottom of the sample container 104 to the cap top 130 of the container cap 116.

Wicking member 150 may have a wicking height measured from the wick proximal end 142 to the wick distal end. In some embodiments, the wicking height may be between about 10.0mm to about 20.0 mm. More specifically, the wicking height may be between about 14.0mm to about 15.0 mm. For example, the wicking height may be about 14.8 mm.

As shown in fig. 1D, the reference electrode material 149 may be positioned or disposed at least partially within a peel-off (divot), depression, or concave region in the center of the reservoir cap 116 above the wicking member 150. When the reference sensor 122 is a cured or hardened conductive ink or solution (e.g., Ag-AgCl ink), the peeled, recessed, or concave area may serve as a receiving space for the fluid ink or solution to be cured.

In some embodiments, the reference electrode material 149 may have a reference electrode height and a reference electrode width. The reference electrode height may be between about 0.2mm and 1.0 mm. For example, the reference electrode height may be about 0.4 mm. The reference electrode width may be between about 2.0mm to about 5.0 mm. For example, the reference electrode width may be about 3.0 mm. One advantage of the reference sensor 122 disclosed herein is that the reference sensor 122 can be used as a stable reference electrode or to provide a stable reference potential for testing or operation for up to 10 hours.

FIG. 1D also shows that sensor device 100 may include a vent 160 defined along a bottom side of sample chamber 108. In other embodiments not shown in the figures, vent 160 may be defined along chamber sidewall 112 of sample chamber 108.

The vent 160 may be covered by a first gas permeable membrane. The vent 160 and the first gas-permeable membrane may be configured to allow gas 162 to enter the sample chamber 108.

In some embodiments, the gas 162 may be ambient air (e.g., air in a laboratory, clinical environment, or testing facility). In other embodiments, gas 162 may include a combination of pressurized oxygen, carbon dioxide, nitrogen, and argon. By providing an oxygen-rich environment within sample chamber 108, aeration of the sample may accelerate the growth of the microbial population within the sample.

In an alternative embodiment not shown in the figures, a vent 160 may be defined along the cap top 130 of the container cap 116 and gas 162 may be pumped from the top of the sample container 104 into the sample chamber 108.

Gas 162 (e.g., ambient air) may be pumped into sample chamber 108 by a micro-pump or another pump-type device integrated within reader device 190. Gas 162 (e.g., ambient air) may be pumped or otherwise directed into sample chamber 108 through vent 160 and the first gas-permeable membrane at a constant flow rate of between about 1.0 mL/minute to 10.0 mL/minute. In other embodiments, gas 162 (e.g., ambient air) may be pumped or otherwise directed into sample chamber 108 through vent 160 and the first gas-permeable membrane at a particular duty cycle or interval.

In certain embodiments, the second gas-permeable membrane may cover at least a portion of the bottom surface of the container cap 116. The second gas-permeable membrane may allow any gas 162 pumped or otherwise directed into the sample chamber 108 to exit the sample chamber 108 while also preventing any fluid within the sample chamber 108 from escaping the sample container 104.

In some embodiments, the first and second breathable films may be made of the same material. The first and second breathable films may be made of hydrophobic breathable films or sheets. For example, both the first and second breathable films may be made of or comprise Polytetrafluoroethylene (PTFE).

As shown in fig. 1D, the container cap 116 may be removably or removably coupled or secured to the sample container 104 by being screwed onto the proximal portion of the sample container 104 via a threaded connection 164. When container cap 116 (used as part of reference sensor 122) is secured or coupled to sample container 104 by threaded connection 164, gas flow channel 166 may be created as air enters vent port 160, passes through the first gas-permeable membrane, and into sample chamber 108. The air then exits the sample chamber 108 through the second vented membrane and an air gap 168, the air gap 168 being defined between the container cap 116 and the threads of the sample container 104.

Container cap 116 may be made in part of a transparent or clear material or a transparent or clear non-conductive material. In other embodiments, the container cap 116 may be partially made of a translucent or see-through material. For example, at least a portion of the wicking member 150 may be visible through the side of the container cap 116. This may allow a user or operator of the sensor device 100 to observe wicking of the fluid sample from the wick distal end 154 to the wick proximal end 152 when the container cap 116 is secured to the sample container 104 and ensure that at least some of the sample is able to reach the reference electrode material 149 at the wick proximal end 152. In some embodiments, the container cap 116 may be made in part of clear or transparent polymeric material, glass, or a combination thereof.

In some embodiments, the sample container 104, the container cap 116, or a combination thereof may be made in part of an inert polymeric material. For example, the sample container 104, the container cap 116, or a combination thereof may be made in part from at least one of: polyoxymethylene, polyamide, polyethylene, acrylonitrile butadiene styrene, polycarbonate, polypropylene or copolymers or composites thereof. In other embodiments, the sample container 104, the container cap 116, or a combination thereof may be made in part from a glass material, such as borosilicate glass or a ceramic material.

Fig. 2 shows that when the sample container 104 is made of a polymeric material, the active sensor 106 can also be insert molded into a portion of the chamber sidewall 112. For example, in forming the sample container 104 by injection molding, the active sensor 106 may be insert molded into the chamber sidewall 112.

When active sensor 106 is insert molded into a portion of chamber sidewall 112 of sample chamber 108, active sensor 106 may have its lateral sides 136 encapsulated by the polymeric material used to fabricate chamber sidewall 112.

In the embodiment shown in fig. 2, active sensor 106 can be insert molded such that active electrode layer 132 faces chamber cavity 109 to allow a sample within chamber cavity 109 to make fluid contact with active electrode layer 132 through at least a portion of chamber sidewall 112 surrounding window opening 114.

Fig. 3A and 3B are black and white images of active sensor 106 insert molded into a polymeric material representing the material used to construct chamber sidewalls 112 of sample chamber 108 (see, e.g., fig. 1A-1D). In some embodiments, sample chamber 108 may be made in part of an inert polymeric material such as polyoxymethylene, polyamide, polyethylene, acrylonitrile butadiene styrene, polycarbonate, or polypropylene.

Fig. 3A shows a top view of the side of the active sensor 106 covered by the active electrode layer 132. As previously described, the active sensor 106 can be insert molded such that the active electrode layer 132 faces the chamber cavity 109 to allow a sample within the chamber cavity 109 (see, e.g., fig. 1D) to be in fluidic contact with exposed areas of the active electrode layer 132.

Fig. 3B shows a top view of the side of the active sensor 106 opposite the active electrode layer 132. The side of the active sensor 106 shown in fig. 3B may be used to contact a conductive connection of the reader device 190 (see, e.g., fig. 14 and 15). As will be discussed in more detail in the following sections, this side of the active sensor 106 may be referred to as a conductive layer.

As shown in fig. 3A and 3B, the lateral sides 136 of the active sensor 106 may be encapsulated by a polymeric material. This may ensure that only the exposed portions of active electrode layer 132 contact the fluid sample within sample chamber 108, thereby producing a more accurate measurement of the solution properties of the fluid sample.

Although not shown in the figures, the present disclosure contemplates that active sensor 106 can be affixed or otherwise coupled to chamber sidewall 112 by locally melting (e.g., by ultrasonic welding) a portion of chamber sidewall 112 surrounding window opening 114 (see, e.g., fig. 1B-1D for the location of window opening 114), and pressing active sensor 106 onto the melted portion of chamber sidewall 112. Once the melted portion of chamber sidewall 112 cools, active sensor 106 is affixed or coupled to chamber sidewall 112.

FIG. 4A illustrates a perspective view of one embodiment of the active sensor 106 with two of the lateral sides 136 of the active sensor 106 visible. As shown in fig. 4A, the active sensor 106 may be shaped substantially as a flat or truncated rectangular prism. In other embodiments, active sensor 106 may be substantially disk-shaped or shaped as a flat or truncated polygonal prism (e.g., a flat or truncated pentagonal prism or a hexagonal prism).

Fig. 4A also illustrates that when the active sensor 106 is shaped substantially as a rectangular prism, the active sensor 106 may have a sensor length dimension 400, a sensor width dimension 402, and a sensor height dimension 404. In some embodiments, the sensor length dimension 400 may be between about 100 μm to 6.0mm, the sensor width dimension 402 may be between about 100 μm to 6.0mm, and the sensor height dimension 404 may be between about 10 μm to 0.70 mm. For example, when the active sensor 106 is shaped substantially as a rectangular prism, the active sensor 106 may have a sensor length dimension 400 of about 6.0mm, a sensor width dimension 402 of about 6.0mm, and a sensor height dimension 404 of about 0.61 mm.

FIG. 4B illustrates a side view of one embodiment of active sensor 106 for measuring the oxidation-reduction potential (ORP) of a sample. In this embodiment, the active sensor 106 may have an active electrode layer 132 made of a noble metal. For example, the active electrode layer 132 may be made of platinum, gold, or a combination or composite thereof.

The active electrode layer 132 may be adhered to one side of the conductive substrate 406 via an adhesive layer 408. The conductive substrate 406 may be made of a conductive material such as Stainless Steel (SS). For example, the conductive substrate 406 may be an SS 316. In other embodiments, the conductive substrate 406 may be made of aluminum, copper, or any combination or composite of aluminum, copper, or stainless steel.

In some embodiments, adhesion layer 408 may be a thin layer of chromium (Cr). Alternatively, the adhesion layer 408 may be a thin layer of gold, nickel, titanium, or tantalum. An adhesion layer 408 may be disposed between the conductive substrate 406 and the active electrode layer 132.

In an alternative embodiment, the active electrode layer 132 may be deposited directly onto one side of the conductive substrate 406 without the adhesion layer 408.

The active electrode layer 132 may have an active electrode layer thickness 410 between about 50nm to 500nm (e.g., about 400 nm). Adhesion layer 408 can have an adhesion layer thickness 412 between about 5nm and 50nm (e.g., about 20 nm). The ratio of adhesion layer thickness 412 to active electrode layer thickness 410 may be between about 1:10 and 1: 20.

The conductive substrate 406 may have a substrate layer thickness 414. The substrate layer thickness may be between about 10 μm to 0.70mm (e.g., about 0.61 mm).

Fig. 4C shows a side view of another embodiment of an active sensor 106 for measuring the pH of a sample. In this embodiment, the active sensor 106 may have an active electrode layer 132 made of a pH sensitive material. The pH sensitive material may be deposited as a layer directly onto the conductive substrate 406 or via the adhesion layer 408.

For example, the active electrode layer 132 may be made of metal oxide. For example, the active electrode layer 132 may be made of tantalum pentoxide (Ta) ₂ O ₅ ) And (4) preparing. In other embodiments, the active electrode layer 132 may be made of silicon dioxide (SiO) ₂ ) Silicon nitride (Si) ₃ N ₄ ) Alumina (Al) ₂ O ₃ ) Titanium dioxide (TiO) ₂ ) Hafnium oxide (HfO) ₂ ) Iridium dioxide (TrO) ₂ ) Ruthenium dioxide (RuO) ₂ ) Zirconium dioxide (ZrO) ₂ ) Or a combination or composite thereof.

The conductive substrate 406 may be made of a conductive material such as Stainless Steel (SS). For example, the conductive material may be SS 316. In other embodiments, the conductive substrate 406 may be made of aluminum, copper, or any combination or composite of aluminum, copper, or stainless steel.

In some embodiments, adhesion layer 408 may be a thin layer of chromium (Cr). Alternatively, adhesion layer 408 may be a thin layer of gold, nickel, titanium, or tantalum. An adhesion layer 408 may be disposed between the conductive substrate 406 and the active electrode layer 132.

As previously described, the active electrode layer 132 may be deposited directly onto the conductive substrate 406 without the adhesion layer 408.

The active electrode layer 132 may have an active electrode layer thickness 410 between about 50nm to 500nm (e.g., about 400 nm). Adhesion layer 408 can have an adhesion layer thickness 412 between about 5nm and 50nm (e.g., about 20 nm). The ratio of adhesion layer thickness 412 to active electrode layer thickness 410 may be between about 1:10 and 1: 20.

The conductive substrate 406 may have a substrate layer thickness 414. The substrate layer thickness may be between about 10 μm to 0.70mm (e.g., about 0.61 mm).

Fig. 4D shows a side view of another embodiment of an active sensor 106 for measuring the pH of a sample. In this embodiment, the platinum layer 416 may be modified using surface modification techniques. For example, an oxygen plasma treatment may be used to oxidize platinum layer 416 to produce platinum oxide/platinum dioxide (PtO) ₂ ) Layer 418. The platinum oxide layer 418 thus formed is capable of responding to hydrogen ions and functions as a pH sensitive layer. In this way, the platinum oxide layer 418 may serve as the active electrode layer 132.

The platinum layer 416 may be adhered to the conductive substrate 406 via the adhesion layer 408. The conductive substrate 406 may be made of a conductive material such as Stainless Steel (SS). For example, the conductive substrate may be SS 316. In other embodiments, the conductive substrate 406 may be made of aluminum, copper, or any combination or composite of aluminum, copper, or stainless steel.

In some embodiments, adhesion layer 408 may be a thin layer of chromium (Cr). Alternatively, adhesion layer 408 may be a thin layer of gold, nickel, titanium, or tantalum. An adhesion layer 408 may be disposed between the conductive substrate 406 and the active electrode layer 132.

In an alternative embodiment, the platinum layer 416 may be deposited directly onto one side of the conductive substrate 406 without the adhesion layer 408.

The platinum layer 416 may have a layer thickness between about 50nm and 500nm (e.g., about 400 nm). Adhesion layer 408 can have an adhesion layer thickness 412 between about 5nm and 50nm (e.g., about 20 nm).

The conductive substrate 406 may have a substrate layer thickness 414. The substrate layer thickness may be between about 10 μm to 0.70mm (e.g., about 0.61 mm).

The platinum oxide layer 418 may have an oxide layer thickness 420. The oxide layer thickness 420 may be between about 10nm and 100 nm.

As previously mentioned, the deposited layers may be selected to achieve a certain desired sensitivity or specificity for a particular analyte. Other surface modification techniques, such as self-assembled monolayers (SAMs), biological functionalization with antibodies, binding to antibody fragments, binding to aptamers, binding to DNA, and plasma treatment, can also be employed to alter the surface properties of the deposited layers, thereby modulating their specificity and sensitivity.

Fig. 5A shows a side view of yet another embodiment of an active sensor 106. This embodiment of active sensor 106 takes advantage of the scale and efficiency of Printed Circuit Board (PCB) manufacturing techniques.

The active sensor 106 may be made of a non-conductive PCB substrate 500 that is partially covered by the active electrode layer 132. In some embodiments, the non-conductive PCB substrate 500 may be made of polyimide. In other embodiments, the non-conductive PCB substrate 500 may be made of a glass-reinforced epoxy laminate material (such as FR-4 composite). In some embodiments, the PCB substrate 500 may be a flexible PCB material.

In some embodiments, the active electrode layer 132 may be made of a noble metal. For example, the active electrode layer 132 may be made of platinum (see, e.g., fig. 5A, 5B, and 6A-6C), gold (see, e.g., fig. 6A-6C), or a combination or composite thereof. Platinum or gold may be electrodeposited or sputter deposited onto PCB substrate 500.

The active electrode layer 132 may have an active electrode layer thickness of at least 50 nm. In some embodiments, the active electrode layer 132 may have an active electrode layer thickness of at least 400 nm. When active electrode layer 132 is made of platinum, active sensor 106 can be used to measure or monitor the ORP of the sample.

In an alternative embodiment, the platinum layer deposited on the non-conductive PCB substrate 500 may be modified with a surface modification technique to convert the platinum layer to a pH sensitive layer (see, e.g., fig. 4D). For example, an oxygen plasma treatment may be used to oxidize a platinum layer to produce platinum oxide (PtO) ₂ ) A layer. The platinum oxide layer thus formed can respond to hydrogen ions and can be used as a pH sensitive layer. In this embodiment, the active sensor 106 may be used to measure or monitor the pH of the sample.

The PCB substrate 500 may be patterned with a conductive contact or conductive contact layer 502 on a side of the substrate opposite the active electrode layer 132. In some embodiments, the conductive contact layer 502 may be a gold layer. In other embodiments, the conductive contact layer 502 may be made of another type of conductive metal, such as platinum, nickel, copper, or alloys or composites thereof.

As shown in fig. 5A, active electrode layer 132 may be electrically coupled to a conductive contact or conductive contact layer 502 through one or more conductive vias 504. In one embodiment, the conductive vias 504 may be partially made of copper or a copper alloy. In other embodiments, the conductive vias 504 may be made of another type of conductive metal, such as gold.

In some embodiments, each active sensor 106 may have at least one conductive via 504 positioned in the center of the sensor package. In other embodiments, the conductive vias 504 may be located near a perimeter or edge of the sensor package.

The conductive vias 504 may be formed by electroplating, deposition, or a combination thereof. In addition, additional features or patterns may be formed on PCB substrate 500 using standard PCB etching processes.

Fig. 5B shows a single PCB board covered by an active electrode layer 132 (e.g., platinum), which can be singulated into a plurality of individual active sensors 106. For example, one PCB board may be singulated to produce 400 to 500 active sensors 106.

Fig. 6A is a black and white image showing active sensor 106 including three separate active electrodes, including a gold (Au) active electrode 600A, a first platinum (Pt) active electrode 600B, and a second Pt active electrode 600C. The active sensor 106 may be produced using the PCB fabrication techniques discussed previously. The only difference is that different active electrode materials (e.g., Au and Pt) are plated or deposited on the same non-conductive PCB substrate 500. For example, one portion or strip of the non-conductive PCB substrate 500 may be covered by a first active electrode material or layer (e.g., Au), while other portions or strips of the same non-conductive PCB substrate 500 may be covered by a second active electrode material or layer (e.g., Pt).

As shown in fig. 6A, active sensor 106 may be coupled (e.g., adhered or insert molded) to a portion of a side chamber wall 112 of sample chamber 108. Since the sample container 104 shown in FIG. 6A is fabricated as a transparent container, the active electrode side of the active sensor 106 can be seen through the transparent wall of the sample chamber 108. When sample chamber 108 is filled with a fluid sample (not shown in FIG. 6A), the fluid sample may contact gold active electrode 600A, first platinum active electrode 600B, and second platinum active electrode 600C through window openings 114 defined along chamber sidewalls 112.

One advantage of active sensor 106 including multiple active electrodes is that each electrode can report a unique potential relative to the same reference electrode or reference sensor (e.g., reference sensor 122). Furthermore, the active electrodes may be made of different materials, so that different solution properties (e.g., ORP and pH) of the sample can be measured or monitored simultaneously.

Although not shown in the figures, the present disclosure contemplates that an active sensor 106 made of multiple active electrodes arranged as an active electrode array (e.g., a 96-electrode array) may be integrated into a single sensor device 100 to simultaneously measure multiple solution properties of a sample. The plurality of active electrodes may be patterned on the non-conductive PCB substrate 500 using techniques common in the PCB industry, including selective etching, photoresist layers, shadow masking, or a combination thereof.

Fig. 6B is a black and white image showing a close-up view of the contact side of the active sensor 106 shown in fig. 6A. For example, as shown in fig. 6B, each active electrode may have its own conductive contact strip 602 or portion, which conductive contact strip 602 or portion is deposited or plated on the opposite side of the non-conductive PCB substrate 500. For example, the conductive contact strips 602 or portions may be made of gold. The conductive contact strip 602 or portion may be a segmented example of the conductive contact layer 502 (see, e.g., fig. 5A). The active electrode may be electrically coupled to the conductive contact through a conductive via (not shown in fig. 6B) extending through the non-conductive PCB substrate 500.

Fig. 6C is a black and white image showing a single PCB board that may be singulated into individual active sensors 106 (see, e.g., fig. 6A and 6B). As previously described, the non-conductive PCB board may be covered on one side by an active electrode layer 132 using electroplating or sputter deposition. The other side of the PCB board may be partially covered by a conductive contact layer 502 (also via electroplating or deposition techniques). The active electrode layer 132 may be electrically coupled to the conductive contact layer 502 by conductive vias 504 extending through the non-conductive PCB board. As previously described, one PCB board processed in this manner may be singulated to produce 400 to 500 active sensors 106.

Fig. 7 shows yet another embodiment of an active sensor 106 made by covering a non-conductive polymer substrate 700 including vias 702 with an active electrode layer 132 and a conductive contact layer 502.

The non-conductive polymer substrate 700 may be a substrate made of any type of injection molded plastic, such as polyamide, polycarbonate, polyoxymethylene, polystyrene, acrylonitrile butadiene styrene, polypropylene, polyethylene, or copolymers or blends thereof.

In some embodiments, the active electrode layer 132 is a noble metal layer. For example, the active electrode layer 132 may be a platinum layer, a gold layer, or a combination or composite thereof. A platinum or gold layer may be deposited or otherwise applied onto the conductive polymer substrate 700 via sputter deposition (e.g., Physical Vapor Deposition (PVD) sputter deposition), evaporation deposition, or electrodeposition. In some embodiments, a platinum or gold layer may be printed using screen printing.

The active electrode layer 132 may have an active electrode layer thickness of at least 50 nm. In some embodiments, the active electrode layer 132 may have an active electrode layer thickness of at least 400 nm. When active electrode layer 132 is made of platinum or gold, active sensor 106 can be used to measure or monitor the ORP of the sample.

In an alternative embodiment, the platinum layer deposited on the non-conductive polymer substrate 700 may be modified with a surface modification technique to convert the platinum layer to a pH sensitive layer (see, e.g., fig. 4D). For example, a platinum layer may be oxidized using an oxygen plasma treatment to produce platinum oxide (PtO) ₂ ) And (3) a layer. The platinum oxide layer thus formed can respond to hydrogen ions and can be used as a pH sensitive layer. In this embodiment, the active sensor 106 may be used to measure or monitor the pH of the sample.

In some embodiments, the conductive contact layer 502 may be a gold layer. In other embodiments, the conductive contact layer 502 may be made of another type of conductive metal, such as platinum, nickel, copper, or alloys or composites thereof.

The vias 702 may have a diameter between about 10 μm to 100 μm. In some embodiments, active sensor 106 may have a width dimension of between about 100 μm to 6.0mm and a length dimension of between about 100 μm to 6.0 mm. For example, the active sensor 106 may have a width dimension of about 100 μm and a length dimension of about 100 μm.

Fig. 8A and 8B are side cross-sectional views illustrating two different embodiments of active sensor 106. In both embodiments, the ends of the vias 702 are covered by the active electrode layer 132 and the conductive contact layer 502. As shown in fig. 8A and 8B, the conductive coating may cover lateral sides of the via 702.

In the embodiment shown in fig. 8A, the conductive coating is composed of the same material as the active electrode layer 132. In the embodiment shown in fig. 8B, the conductive coating is composed of the same material as the conductive contact layer 502. Whether the lateral sides of the via 702 are covered by the active electrode material or the conductive coating material may be determined by which layer is first deposited on the non-conductive polymer substrate 700.

As a more specific example, when the active electrode layer 132 is a platinum layer and the platinum layer is first deposited on the non-conductive polymer substrate 700, the conductive coating covering the lateral sides of the through-hole may be a platinum coating. Alternatively, when the conductive contact layer 502 is a gold layer and the gold layer is first deposited on the non-conductive polymer substrate 700, the conductive coating covering the lateral sides of the via may be a gold coating.

In some embodiments (e.g., as shown in fig. 8A and 8B), the entire via 702 need not be filled as long as the lateral sides of the via 702 are covered by the conductive coating. The conductive coating may serve as an electrical or conductive path between the two sides of the active sensor 106. Alternatively, at least a portion of the via 702 may be filled with a conductive coating.

In some embodiments, the non-conductive polymer substrate 700 may begin as a plastic sheet with an array of small vias 702 defined throughout the plastic sheet. The plastic sheet may then be first covered with the active electrode layer 132 or the conductive contact layer 502. Then, the lateral sides of the through-hole 702 and at least one end of the through-hole 702 may be coated with a material for initially covering the plastic sheet. The other side of the plastic sheet, including the remaining open ends of the vias 702, may then be covered by the conductive contact layer 502 or the active electrode layer 132, depending on which layer is first performed. Once both sides of the plastic sheet are covered, the plastic sheet can be singulated to produce individual active sensors 106. The active sensor 106 produced in this way can be as small as 100 μm by 100 μm (W by L).

Fig. 9 illustrates that a large piece of non-conductive plastic or large PCB (covered by an active electrode layer, an adhesion layer, a conductive layer, or a combination thereof) may be processed using the methods disclosed herein and then singulated into a plurality of active sensors 106. In some embodiments, a large piece of non-conductive plastic or a large PCB may be singulated using sawing, laser cutting, metal shearing, hot wire cutting, dye cutting, stamping, or combinations thereof.

Fig. 10 shows a side view of another embodiment of a sensor device 100 comprising an active sensor 106 made of a conductive pin 1000. In some embodiments, conductive pin 1000 may be a stainless steel pin. The conductive pin 1000 may be partially covered by the active electrode layer 132 extending into the chamber cavity 109. The portion of the conductive pin 1000 covered by the active electrode layer 132 may extend into the chamber cavity 109 to allow a sample within the chamber cavity 109 to make fluidic contact with the active electrode layer 132.

The conductive pin 1000 can be coupled to at least a portion of the chamber sidewall 112 at a window opening defined along the chamber sidewall 112. The opposite end of the conductive pin 1000 (the end not covered by the active electrode layer 132) may extend out of the chamber sidewall 112 to contact one or more conductive connections of the reader device 190. Conductive pin 1000 may be substantially shaped as a cylinder with rounded edges.

Conductive pins 1000 may be insert molded or bonded to chamber sidewalls 112.

In some embodiments, the active electrode layer 132 is a noble metal layer. For example, the active electrode layer 132 may be a platinum layer, a gold layer, or a combination or composite thereof. A platinum or gold layer may be deposited or otherwise applied onto conductive pin 1000 via sputter deposition (e.g., Physical Vapor Deposition (PVD) sputter deposition), evaporative deposition, or electrodeposition.

The active electrode layer 132 may have an active electrode layer thickness of at least 50 nm. In certain embodiments, the active electrode layer 132 may have an active electrode layer thickness of at least 400 nm. When active electrode layer 132 is made of platinum or gold, active sensor 106 can be used to measure or monitor the ORP of the sample.

In an alternative embodiment, the platinum layer deposited on the conductive pin 1000 may be modified with a surface modification technique to convert the platinum layer to a pH sensitive layer. For example, a platinum layer may be oxidized using an oxygen plasma treatment to produce platinum oxide (PtO) ₂ ) And (3) a layer. The platinum oxide layer thus formed can respond to hydrogen ions and can be used as a pH sensitive layer. In this embodiment, the active sensor 106 may be used to measure or monitor the pH of the sample.

FIG. 11 is a graph showing the change in oxidation-reduction potential (ORP) of three samples containing E.coli ATCC25922 measured over time using three different sensors. As shown in FIG. 11, one sensor is a conventional ORP probe commonly used in diagnostic devices (e.g., a commercially available ORP probe issued by Mettler-Toledo LLC). The other two sensors are embodiments of the sensor device 100 disclosed herein, one having an active sensor 106 comprising a platinum active electrode layer deposited by evaporation deposition, and the other having an active sensor 106 comprising a plated platinum active electrode layer. Active sensor 106 in both embodiments is coupled to at least a portion of chamber sidewall 112 at a window opening 114 defined along chamber sidewall 112. In these embodiments, active sensor 106 is positioned such that no portion of active sensor 106 extends into chamber 109 of sample chamber 108. When each of the two sensor devices 100 is placed within the reader device 190, the change in ORP is measured by the reader device 190.

As shown by the three E.coli growth curves, the two sensor devices 100 perform similarly to commercially available ORP probes. Any variation in the signal response is within an acceptable range.

FIG. 12 is a graph showing the change in pH of four samples containing different starting concentrations of E.coli ATCC25922 measured over time using the sensor device 100 disclosed herein with a sensor device comprising tantalum oxide/tantalum pentoxide (Ta) ₂ O ₅ ) An active sensor 106 of the active electrode layer.

As shown in fig. 12, the measured e.coli growth curve follows the classical growth pattern of the bacteria: there is a lag phase at the beginning, followed by an exponential phase, and ending with a stationary phase. The pattern or shape of the curve can be attributed to the cellular activity performed by the active e.coli in the sample.

Fig. 13A shows a perspective view of a reader device 190 configured to determine a solution characteristic of a sample within sample chamber 108 of sensor device 100. When the active sensor 106 and the reference sensor 122 are electrically coupled via a conductive connection or interface within the reader device 190, the reader device 190 can determine a solution characteristic of the sample based on a potential difference measured between the active sensor 106 (more specifically, the active electrode layer 132) and the reference sensor 122 (more specifically, the reference electrode material 149). The reader device 190 may act as a voltmeter or another type of high impedance amplifier or source meter to measure the relative change in equilibrium potential at the interface between the electrode layers in contact with the sample fluid containing the electroactive redox species or charged ions.

The solution properties of the sample may be a function of the amount of electroactive redox species or H resulting from growth or metabolism (or lack thereof) of infectious agents within the sample ⁺ The amount of ions varies. For example, the amount of electroactive redox species in a sample may change due to cellular activity by an infectious agent. As a more specific example, the amount of oxygen and the amount of electron donor can be related to energy carriers (such as Nicotinamide Adenine Dinucleotide (NADH) and Flavin Adenine Dinucleotide (FADH) due to growth or metabolism (or lack thereof) of the infectious agent within the sample ₂ ) ) of the amount of the composition.

When the active electrode layer 132 of the sensor device 100 is made of a redox sensitive material such as platinum (Pt) or gold (Au), the reader device 190 can measure the oxidation-reduction potential (ORP) of the sample. Furthermore, when the active electrode layer 132 of the sensor device 100 is made of a pH sensitive material, such as a metal oxide layer, the reader device 190 may also measure the pH of the sample.

Fig. 13A shows that the reader device 190 may include a reader housing 1300 configured to house certain functional components of the reader device 190, including a master controller 1301 (see, e.g., fig. 13C), a signal readout control unit 1303 (see, e.g., fig. 14, 15A, and 15B), a thermal control module 1305 (see, e.g., fig. 13B, 13C, and 13D), and a ventilation control module 1307 (see, e.g., fig. 13B and 13C). The reader housing 1300 may also expose a touch screen display 1302 configured to display measurements and allow a user to input commands to the reader device 190.

The lid 1304 or cover of the reader device 190 may be opened or lifted to expose a container receiving space 1306 (see, e.g., fig. 13B) configured to receive or receive the sensor device 100 for analysis or investigation by the reader device 190.

Fig. 13B shows a partial cross-sectional view of the reader device 190 with the sensor device 100 filled with a sample loaded within the reader device 190. When the sensor device 100 is positioned within the receptacle-receiving space 1306, the reference electrode contact 1308 of the reader device 190 may be placed or moved into contact with the reference electrode material 149 positioned on the receptacle cap 116 (see, e.g., fig. 1D) of the sensor device 100. Further, when the sensor device 100 is positioned within the receptacle-receiving space 1306, the active electrode contact 1310 of the reader device 190 may be placed or moved into contact with a conductive substrate layer or a conductive contact (e.g., any of the conductive substrate 406 of fig. 4B-4D or the conductive contact layer 502 of fig. 5A) of the active sensor 106.

In some embodiments, the reference electrode contact 1308 and the active electrode contact 1310 may include one or more conductive pogo pins (pogo pins) or spring-loaded pins (spring-loaded pins), conductive blade contacts, or a combination thereof. More specifically, the conductive pogo pins or blade contacts may be made of copper, nickel, stainless steel, or alloys thereof.

The reference electrode contact 1308 and the active electrode contact 1310 may be electrically coupled to the signal readout control unit 1303. The signal readout control unit 1303 may include one or more processors, chipsets, or chip modules programmed to convert and read signals obtained from the active sensor 106 and the reference sensor 122 of the sensor device 100.

Fig. 13B also shows that the reader device 190 may include a thermal control module 1305 and a ventilation control module 1307. Thermal control module 1305 may be configured to incubate a sample-filled sensor device 100. Thermal control module 1305 may incubate sensor device 100 by heating at least a portion of sensor device 100 via heating block 1318 (see, e.g., fig. 13D). In some embodiments, heating block 1318 may heat a lateral side of sample chamber 108 opposite active sensor 106. In certain embodiments, heating block 1318 may partially surround or support sample chamber 108 to heat sensor device 100.

In some embodiments, heating block 1318 may be made in part of aluminum. In other embodiments, the heating block 1318 may be made in part of another type of thermally conductive metal material.

Sensor device 100 can be heated to an incubation temperature of between about 30 ℃ and 40 ℃ (e.g., about 35 ℃ ± 2 ℃). The sensor device 100 may be incubated for an incubation period. The incubation period may vary from 15 minutes to over 48 hours. The incubation period may be adjusted according to the type of suspected infectious agent in the sample.

In some embodiments, the thermal control module 1305 may be controlled by a master controller 1301 (see, e.g., fig. 13C) of the reader device 190. In other embodiments, the thermal control module 1305 may be controlled by another controller or module within the reader device 190, or by the signal readout control unit 1303.

In some embodiments, a nutrient solution or a stimulation solution may be introduced into sample chamber 108 prior to incubating sensor device 100. For example, the nutrient solution can be a solution containing bacto tryptone, yeast extract, beef extract, cation-adjusted Mueller Hinton broth (CAMHB), starch, acid hydrolysate of casein, calcium chloride, magnesium chloride, sodium chloride, blood or lysed blood including Lysed Horse Blood (LHB), a CAMHB-LHB mixture, glucose, or a combination thereof. When the sample comprises a bodily fluid, the nutrient solution may be used to counteract the buffering effect of ions or substances present in the sample.

Vent control module 1307 may be configured to vent the sample within sample chamber 108 by pumping gas 162 (e.g., see fig. 1D) into chamber 109 containing the sample. Gas 162 may be pumped into sample chamber 108 through a vent 160 defined along the bottom of sample chamber 108 (see, e.g., fig. 1D).

Aeration of the sample can increase the growth rate of the infectious agent within the sample by increasing the oxygen supply to the infectious agent. Furthermore, aeration of the sample may also cause infectious agents to detach from the inner walls of sample chamber 108, thereby inhibiting biofilm formation.

Fig. 13C shows a perspective view of a portion of the reader device 190 with the reader housing 1300 removed. As shown in fig. 13C, a vent control module 1307 may deliver gas 162 via a gas delivery conduit 1312 that connects vent control module 1307 to sensor device 100. In some embodiments, at least a segment of gas delivery conduit 1312 may be positioned along or wrapped around the base or bottom of reader device 190.

FIG. 13D shows a close-up view of gas nozzle 1314 coupled to the bottom of sensor device 100 to vent a sample in sample chamber 108. The gas nozzle 1314 may be disposed at the terminal or distal end of the gas delivery conduit 1312.

As shown in fig. 13D, gas nozzle 1314 may be connected to a vent 160 at the bottom of sample chamber 108 via a nozzle interface 1316. In some embodiments, the nozzle interface 1316 may be an O-ring. In other embodiments, the nozzle port 1316 may be another type of gasket or fluid-tight port.

In some embodiments, the gas 162 may be ambient air (e.g., air in a laboratory, clinical environment, or testing facility). In other embodiments, gas 162 may include a combination of pressurized oxygen, carbon dioxide, nitrogen, and argon. By providing an oxygen-rich environment within sample chamber 108, aeration of the sample may accelerate the growth of the microbial population within the sample.

Vent control module 1307 may pump gas 162 into sample chamber 108 at a constant flow rate between about 1.0mL/min to 10.0 mL/min.

In some embodiments, ventilation control module 1307 may be controlled by master controller 1301 (see, e.g., fig. 13C). In other embodiments, ventilation control module 1307 may be controlled by another controller or module within reader device 190, or by signal readout control unit 1303. For example, the amount of gas 162 (e.g., ambient air) pumped or otherwise directed into sample chamber 108 may be dictated by a change in the solution characteristics of the sample, or the lack of any such change, detected by reader device 190.

Fig. 14 shows a method 1400 of manufacturing a sensor device 100 for measuring solution properties of a sample. The method 1400 may include cleaning the conductive substrate 406 (e.g., a stainless steel sheet such as 316 SS) with an acid-base treatment in step 1402.

The conductive substrate 406 may be first cleaned with a series of acid-base treatments to remove any impurities or surface contaminants (e.g., free iron). Such treatment may be performed with nitric acid (10%), followed by ammonium hydroxide (175mM), isopropanol (99%) or acetone. In other embodiments, the conductive substrate 406 may be cleaned and descaled using other acids, bases, alcohols, solvents, or other chemicals.

The method 1400 may also include depositing an adhesive material on one side of the cleaned conductive substrate 406 in step 1404 until an adhesive layer 408 is formed on the cleaned conductive substrate 406. In some embodiments, adhesion layer 408 may be deposited by a sputter deposition technique such as Physical Vapor Deposition (PVD). In some embodiments, adhesion layer 408 may be a chromium (Cr) layer. Chromium may be chosen because it creates a bond to chromium in the stainless steel of the conductive substrate 406. In other embodiments, the adhesion layer 408 may also be a gold (Au) or nickel (Ni) layer.

Step 1404 may also include depositing an adhesive material (e.g., Cr, Au, or Ni) until adhesion layer 408 is at least 20nm thick.

Method 1400 may further include depositing an active electrode material on adhesion layer 408 in step 1406 until active electrode layer 132 is formed on adhesion layer 408. When sensor device 100 is to be used as an ORP sensor, active electrode layer 132 can be a noble metal layer, such as a platinum or gold layer. Depositing the active electrode layer 132 may include depositing an active electrode material (e.g., Pt) using sputter deposition (e.g., PVD), evaporation deposition, or electrodeposition. For some processes, such as evaporation deposition, the conductive substrate 406 may be pre-cleaned with an argon (Ar) plasma etch in vacuum. In other embodiments, the active electrode material may be applied using ink screen printing.

Step 1406 may also include depositing an active electrode material until the active electrode layer 132 is at least 50nm thick. Step 1406 may also include depositing an active electrode material until the active electrode layer 132 is at least 400nm thick. Applicants have found that this minimum thickness is needed to prevent the formation of nano-sized pores in the active electrode layer 132, which would allow a fluid (e.g., a fluid sample) to pass through the active electrode layer 132 and contact other layers of the active sensor 106 (thereby adversely affecting the measurement values). Furthermore, when using an antimicrobial material (e.g., copper or nickel) as the conductive substrate 406, the active electrode layer 132 having a minimum thickness of 400nm may act as a barrier to protect microorganisms in the fluid sample.

In certain embodiments, adhesion layer 408 may be deposited in a vacuum chamber, and active electrode layer 132 may be deposited in the same vacuum chamber immediately after adhesion layer 408.

Alternatively, step 1406 may include depositing a metal layer and surface modifying the metal layer to produce a metal oxide layer. For example, step 1406 may include depositing a platinum layer and oxidizing the platinum layer to produce platinum oxide (PtO) for use as the active electrode layer 132 ₂ ) And (3) a layer. When the sensor device 100 is to be used as a pH sensor, the active electrode layer 132 may be a metal oxide layer (e.g., platinum oxide or tantalum oxide).

The method 1400 may also include singulating the conductive substrate 406 covered by the adhesion layer 408 and the active electrode layer 132 in step 1408. The conductive substrate 406 covered by the adhesive layer 408 and the active electrode layer 132 may be singulated by laser cutting, metal shearing, hot wire cutting, dye cutting, stamping, or sawing. Conductive substrate 406 covered by adhesion layer 408 and active electrode layer 132 may be singulated to produce active sensor 106, with active sensor 106 sized to cover window opening 114 defined along chamber sidewall 112 of sample chamber 108 (see, e.g., fig. 1B-1D and 2).

Method 1400 can also include coupling an active sensor 106 to at least a portion of chamber sidewall 112 in step 1410. Active sensor 106 can be coupled to at least a portion of chamber sidewall 112 such that no portion of active sensor 106 extends into chamber cavity 109 within sample chamber 108, and active electrode layer 132 faces chamber cavity 109 to allow any sample within chamber cavity 109 to make fluid contact with active electrode layer 132 through at least a portion of chamber sidewall 112 surrounding window opening 114. Active sensor 106 can be coupled to at least a portion of chamber sidewall 112 such that active sensor 106 (including active electrode layer 132) is positioned radially outward from an inward-facing or cavity-facing side of chamber sidewall 112 and lateral side 136 of active sensor 106 is not in fluid communication with chamber cavity 109.

In some embodiments, coupling an active sensor to at least a portion of chamber sidewall 112 of sample chamber 108 may further comprise: bead 138 is applied to a portion of chamber sidewall 112 within recess 134, recess 134 is defined along chamber sidewall 112 around window opening 114, active sensor 106 is pressed or placed onto bead 138 within recess 134, and adhesive 138 is cured.

In an alternative embodiment, coupling the active sensor to at least a portion of chamber sidewall 112 of sample chamber 108 may include insert molding active sensor 106 into chamber sidewall 112 when sample chamber 108 is formed by injection molding.

In a further alternative embodiment, coupling the active sensor to at least a portion of chamber sidewall 112 of sample chamber 108 may include locally melting (e.g., by ultrasonic welding) a portion of chamber sidewall 112 surrounding window opening 114, pressing or placing active sensor 106 onto the melted portion of chamber sidewall 112, and allowing the melted portion of chamber sidewall 112 to cool to secure active sensor 106 to chamber sidewall 112.

Fig. 15 illustrates yet another method 1500 of manufacturing a sensor device 100 for measuring solution properties of a sample. The method 1500 may include providing a non-conductive Printed Circuit Board (PCB) substrate 500 (see, e.g., fig. 5A) in step 1502.

The method 1500 may also include depositing an active electrode material on one side of the non-conductive PCB substrate 500 until the active electrode layer 132 is formed on the non-conductive PCB substrate 500 in step 1504. Step 1504 may also include depositing an active electrode material until the active electrode layer 132 is at least 50nm thick. Step 1504 may also include depositing an active electrode material until the active electrode layer 132 is at least 400nm thick. After the deposition step, the active electrode layer 132 may be electrically coupled to the conductive contact or conductive contact layer 502 of the non-conductive PCB substrate 500 by a conductive via 504 extending through the non-conductive PCB substrate 500.

When sensor device 100 is to be used as an ORP sensor, active electrode layer 132 can be a noble metal layer, such as a platinum or gold layer. Depositing active electrode layer 132 may include depositing an active electrode material (e.g., Pt) using sputter deposition (e.g., PVD), evaporation deposition, or electrodeposition.

Method 1500 may also include singulating 1506 the non-conductive PCB substrate 500 covered by the active electrode layer 132 to produce an active sensor 106, the active sensor 106 sized to cover a window opening 114 defined along a chamber sidewall 112 of sample chamber 108. The non-conductive PCB substrate 500 covered by the active electrode layer 132 may be singulated by laser cutting, metal shearing, hot wire cutting, dye cutting, stamping, or sawing. The active sensor 106 may include at least one conductive via 504 extending through the PCB substrate 500.

Method 1500 can also include coupling an active sensor 106 to at least a portion of the chamber sidewall 112 in step 1508. Active sensor 106 can be coupled to at least a portion of chamber sidewall 112 such that no portion of active sensor 106 extends into chamber cavity 109 within sample chamber 108, and active electrode layer 132 faces chamber cavity 109 to allow any sample within chamber cavity 109 to make fluid contact with active electrode layer 132 through at least a portion of chamber sidewall 112 surrounding window opening 114. Active sensor 106 can be coupled to at least a portion of chamber sidewall 112 such that active sensor 106 (including active electrode layer 132) is positioned radially outward from an inward-facing or cavity-facing side of chamber sidewall 112 and lateral side 136 of active sensor 106 is not in fluid communication with chamber cavity 109.

In some embodiments, coupling an active sensor to at least a portion of chamber sidewall 112 of sample chamber 108 may further comprise: bead 138 is applied to a portion of chamber sidewall 112 within recess 134, recess 134 is defined along chamber sidewall 112 around window opening 114, active sensor 106 is pressed or placed onto bead 138 within recess 134, and adhesive 138 is cured.

In an alternative embodiment, coupling the active sensor to at least a portion of chamber sidewall 112 of sample chamber 108 may include insert molding active sensor 106 into chamber sidewall 112 when sample chamber 108 is formed by injection molding.

In a further alternative embodiment, coupling the active sensor to at least a portion of chamber sidewall 112 of sample chamber 108 may include locally melting (e.g., by ultrasonic welding) a portion of chamber sidewall 112 surrounding window opening 114, pressing or placing active sensor 106 onto the melted portion of chamber sidewall 112, and allowing the melted portion of chamber sidewall 112 to cool to secure active sensor 106 to chamber sidewall 112.

Fig. 16 shows yet another method 1600 of manufacturing a sensor device 100 for measuring solution properties of a sample. Method 1600 may include providing a non-conductive polymer substrate 700 including a plurality of vias 702 in step 1602. The method 1600 may also include depositing a conductive contact layer 502 on one side of the polymer substrate 700 in step 1604. Depositing the conductive contact layer 502 can include depositing a conductive material (e.g., Au) on the polymer substrate 700 using sputter deposition (e.g., PVD), evaporation deposition, or electrodeposition.

Method 1600 may also include depositing active electrode layer 132 on the other side of polymer substrate 700 in step 1606. Depositing active electrode layer 132 may include depositing an active electrode material (e.g., Pt) on polymer substrate 700 using sputter deposition (e.g., PVD), evaporation deposition, or electrodeposition.

One end of each of the through holes 702 may be covered by the active electrode layer 132, and the other end of each of the through holes 702 may be covered by the conductive contact layer 502. After the deposition step, the active electrode layer 132 may be electrically coupled to the conductive contact layer 502 via a conductive coating covering the lateral sides of the via 702.

Method 1600 may also include, in step 1608, singulating non-conductive polymer substrate 700 covered by active electrode layer 132 and conductive contact layer 502 to produce active sensor 106, with active sensor 106 sized to cover window opening 114 defined along chamber sidewall 112 of sample chamber 108. The non-conductive polymer substrate 700 covered by the active electrode layer 132 and the conductive contact layer 502 may be singulated by laser cutting, metal shearing, hot wire cutting, dye cutting, stamping, or sawing. Active sensor 106 may include at least one via 702 extending through non-conductive polymer substrate 700.

The method 1600 can also include coupling an active sensor 106 to at least a portion of the chamber sidewall 112 at step 1610. Active sensor 106 can be coupled to at least a portion of chamber sidewall 112 such that no portion of active sensor 106 extends into chamber cavity 109 within sample chamber 108, and active electrode layer 132 faces chamber cavity 109 to allow any sample within chamber cavity 109 to make fluid contact with active electrode layer 132 through at least a portion of chamber sidewall 112 surrounding window opening 114. The active sensor 106 can be coupled to at least a portion of the chamber sidewall 112 such that the active sensor 106 (including the active electrode layer 132) is positioned radially outward from an inward-facing or cavity-facing side of the chamber sidewall 112 and a lateral side 136 of the active sensor 106 is not in fluid communication with the chamber cavity 109.

In some embodiments, coupling an active sensor to at least a portion of chamber sidewall 112 of sample chamber 108 may further comprise: bead 138 is applied to a portion of chamber sidewall 112 within recess 134, recess 134 is defined along chamber sidewall 112 around window opening 114, active sensor 106 is pressed or placed onto bead 138 within recess 134, and adhesive 138 is cured.

In an alternative embodiment, coupling the active sensor to at least a portion of chamber sidewall 112 of sample chamber 108 may include insert molding active sensor 106 into chamber sidewall 112 when sample chamber 108 is formed by injection molding.

In a further alternative embodiment, coupling the active sensor to at least a portion of chamber sidewall 112 of sample chamber 108 may include locally melting (e.g., by ultrasonic welding) a portion of chamber sidewall 112 surrounding window opening 114, pressing or placing active sensor 106 onto the melted portion of chamber sidewall 112, and allowing the melted portion of chamber sidewall 112 to cool to secure active sensor 106 to chamber sidewall 112.

Several embodiments have been described. However, those of ordinary skill in the art will appreciate that various changes and modifications may be made to the present disclosure without departing from the spirit and scope of the embodiments. Elements of systems, apparatuses, devices, and methods shown in any embodiment are exemplary for a particular embodiment and may be used in combination or otherwise on other embodiments within this disclosure. For example, the steps of any method depicted in the figures or described in the present disclosure need not be in the particular order shown or described, or in sequential order, to achieve desirable results. In addition, other step operations may be provided, or steps or operations may be eliminated or omitted from the described methods or processes to achieve desirable results. In addition, any components or parts of any apparatus or system described in this disclosure or depicted in the figures may be removed, eliminated, or omitted to achieve the desired results. Moreover, certain components or features of systems, apparatuses, or devices illustrated or described herein have been omitted for the sake of brevity and clarity.

Accordingly, other embodiments are within the scope of the following claims, and the specification and/or drawings are to be regarded in an illustrative rather than a restrictive sense.

Each of the various variations or embodiments described and illustrated herein has discrete components and features that can be readily separated from or combined with the features of any other variation or embodiment. Modifications may be made to adapt a particular situation, material, composition of matter, process, act or step of a process to the objective, spirit or scope of the present invention.

The methods recited herein may be practiced in any order of the recited events that is logically possible as well as in the recited order of events. In addition, additional steps or operations may be provided or steps or operations may be eliminated, to achieve the desired result.

Further, where a range of values is provided, each intervening value, to the extent that there is a stated upper and lower limit to that range, and any other stated or intervening value in that stated range, is encompassed within the invention. Furthermore, any optional feature of the described variations of the invention may be set out and claimed independently or in combination with any one or more of the features described herein. For example, a description of a range from 1 to 5 should be considered to have the disclosed sub-ranges (e.g., from 1 to 3, from 1 to 4, from 2 to 5, from 3 to 5, etc.) as well as individual numbers within that range (e.g., 1.5, 2.5, etc.) and any whole or partial increments therein.

All prior subject matter (e.g., publications, patents, patent applications) referred to herein is incorporated by reference in its entirety, unless the subject matter otherwise could conflict with the subject matter of the present disclosure (in which case the disclosure set forth herein controls). The referenced items are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the invention is not entitled to antedate such material by virtue of prior invention.

Reference to an item in the singular includes the possibility that a plurality of the same items exist. More specifically, as used herein and in the appended claims, the singular forms "a," "an," "the," and "the" include plural referents unless the context clearly dictates otherwise. It is also noted that the claims may be drafted to exclude any optional element. Accordingly, this statement is intended to serve as antecedent basis for use of such exclusive terminology as "solely," "only," etc. or use of a "negative" limitation in connection with the recitation of claim elements. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

In understanding the scope of the present disclosure, the term "comprising" and its derivatives, as used herein, are intended to be open ended terms that specify the presence of the stated features, elements, components, groups, integers, and/or steps, but do not exclude the presence of other unstated features, elements, components, groups, integers and/or steps. The foregoing also applies to words having similar meanings such as the terms, "including", "having" and their derivatives. Furthermore, the terms "part," "section," "portion," "member," "element" or "part" when used in the singular can have the dual meaning of a single part or a plurality of parts. As used herein, the following directional terms "forward, rearward, above, downward, vertical, horizontal, below, transverse, lateral and vertical" as well as any other similar directional terms refer to those positions of a device or piece of equipment or those directions in which a device or piece of equipment is translated or moved. Finally, terms of degree such as "substantially", "about" and "approximately" as used herein mean a reasonable amount of deviation from the specified value (e.g., a deviation of up to 0.1%, 1%, 5% or 10%, as such variations are appropriate) such that the end result is not significantly or substantially changed.

The disclosure is not intended to be limited to the particular forms set forth, but is intended to cover alternatives, modifications, and equivalents of the variations or embodiments described herein. Moreover, the scope of the present disclosure fully encompasses other modifications and embodiments that may become apparent to those skilled in the art in light of the present disclosure.

Claims (74)

1. A sensor device for measuring a solution property of a sample, the sensor device comprising:

a sample container comprising a sample chamber, wherein the sample chamber comprises a chamber sidewall surrounding a chamber cavity configured to receive the sample,

a reference sensor comprising a reference electrode material and a wick in fluid communication with the sample chamber such that at least some of the sample is drawn by the wick in the direction of the reference electrode material; and

an active sensor made of a conductive substrate partially covered by an active electrode layer, wherein the active sensor is coupled to at least a portion of the chamber sidewall at a window opening defined along the chamber sidewall, wherein no portion of the active sensor extends into the chamber cavity, and wherein the active electrode layer faces the chamber cavity to allow a sample within the chamber cavity to make fluidic contact with the active electrode layer through at least a portion of the chamber sidewall surrounding the window opening,

wherein the solution characteristic of the sample is determined based on a potential difference measured between the active sensor and the reference sensor when the reference sensor and the active sensor are electrically coupled to a reader.

2. The sensor device of claim 1, wherein the solution characteristic measured is oxidation-reduction potential, and wherein the active electrode layer is a platinum layer.

3. The sensor device of claim 1, wherein the measured solution characteristic is pH, and wherein the active electrode layer comprises a platinum oxide layer and a tantalum oxide layer.

4. The sensor device of claim 1, wherein the conductive substrate is stainless steel.

5. The sensor device of claim 1, wherein the active electrode layer has an active electrode layer thickness of between about 50nm and 500 nm.

6. The sensor device of claim 5, wherein the active sensor further comprises an adhesion layer between the conductive substrate and the active electrode layer, wherein the adhesion layer has an adhesion layer thickness between 5nm and 50 nm.

7. The sensor device of claim 6, wherein a ratio of the adhesion layer thickness to the active electrode layer thickness is between about 1:10 and 1: 20.

8. The sensor device of claim 6, wherein the adhesion layer is a chromium layer.

9. The sensor device of claim 1, wherein the active electrode layer has an active electrode layer thickness of at least 50 nm.

10. The sensor device of claim 1, wherein the active sensor is insert molded into the chamber sidewall when the sample container is formed by injection molding.

11. The sensor device of claim 1, wherein the active sensor is press-molded into the chamber sidewall after the sample container is formed by injection molding.

12. The sensor device of claim 1, wherein the chamber sidewall includes a recessed portion defined around the window opening and along an exterior side of the chamber sidewall, and wherein the active sensor is adhered to at least a portion of the chamber sidewall within the recessed portion via an adhesive.

13. The sensor device of claim 1, wherein the active sensor comprises an active electrode side, a conductive substrate side, and a lateral side, the conductive substrate side being opposite the active electrode side, wherein the lateral side is covered by at least one of the chamber sidewalls and an adhesive to prevent the lateral side from contacting the sample.

14. The sensor device of claim 1, wherein the sample chamber is made of at least one of polyoxymethylene, polyamide, polyethylene, acrylonitrile butadiene styrene, polycarbonate, and polypropylene.

15. The sensor device of claim 1, wherein the reference electrode material is a solidified or hardened silver-silver chloride ink deposited or otherwise applied on a wick proximal end of the wick.

16. A sensor device for measuring a solution property of a sample, the sensor device comprising:

a sample container comprising a sample chamber, wherein the sample chamber comprises a chamber sidewall surrounding a chamber cavity configured to receive the sample,

a reference sensor comprising a reference electrode material and a wick in fluid communication with the sample chamber such that at least some of the sample is drawn by the wick in the direction of the reference electrode material; and

an active sensor made of a non-conductive Printed Circuit Board (PCB) substrate partially covered by an active electrode layer, wherein the active electrode layer is electrically coupled to conductive contacts of the PCB substrate via conductive vias extending through the PCB substrate, wherein the active sensor is coupled to at least a portion of the chamber sidewall at a window opening defined along the chamber sidewall, wherein no portion of the active sensor extends into the chamber cavity, and wherein the active electrode layer faces the chamber cavity to allow a sample within the chamber cavity to make fluid contact with the active electrode layer through at least a portion of the chamber sidewall surrounding the window opening,

wherein the solution characteristic of the sample is determined based on a potential difference measured between the active sensor and the reference sensor when the reference sensor and the active sensor are electrically coupled to a reader.

17. The sensor device of claim 16, wherein the PCB substrate is a flexible PCB substrate.

18. The sensor device of claim 16, wherein the PCB substrate is partially made of polyimide.

19. The sensor device of claim 16, wherein the PCB substrate is partially made of FR-4 composite material.

20. The sensor device of claim 16, wherein the conductive via is made of copper.

21. The sensor device of claim 16, wherein the measured solution characteristic is an oxidation-reduction potential, and wherein the active electrode layer is a platinum layer or a gold layer.

22. The sensor device of claim 16, wherein the active electrode layer has an active electrode layer thickness of at least 50 nm.

23. The sensor device of claim 16, wherein the active sensor is insert molded into the chamber sidewall when the sample container is formed by injection molding.

24. The sensor device of claim 16, wherein the measured solution characteristic is pH, and wherein the active electrode layer is a metal oxide layer.

25. The sensor device of claim 16, wherein the chamber sidewall includes a recessed portion defined around the window opening and along an exterior side of the chamber sidewall, and wherein the active sensor is adhered to at least a portion of the chamber sidewall within the recessed portion via an adhesive.

26. The sensor device of claim 16, wherein the active sensor comprises an active electrode side covered by the active electrode layer, a conductive contact side opposite the active electrode side and comprising the conductive contact, and a lateral side, wherein the lateral side is covered by at least one of the chamber sidewall and an adhesive to prevent the lateral side from contacting the sample.

27. A sensor device for measuring a solution property of a sample, the sensor device comprising:

a sample container comprising a sample chamber, wherein the sample chamber comprises a chamber sidewall surrounding a chamber cavity configured to receive the sample,

a reference sensor comprising a reference electrode material and a wicking component in fluid communication with the sample chamber such that at least some of the sample is drawn by the wicking component in the direction of the reference electrode material; and

an active sensor made of a non-conductive polymer substrate comprising a via, wherein one side of the polymer substrate and one end of the via are covered by an active electrode layer, and wherein the other side of the polymer substrate and the other end of the via are covered by a conductive layer, wherein the active electrode layer is electrically coupled to the conductive layer via a conductive coating covering a lateral side of the via,

wherein the active sensor is coupled to at least a portion of the chamber sidewall at a window opening defined along the chamber sidewall, wherein no portion of the active sensor extends into the chamber cavity, and wherein the active electrode layer faces the chamber cavity to allow a sample within the chamber cavity to make fluid contact with the active electrode layer through at least a portion of the chamber sidewall surrounding the window opening,

wherein the solution characteristic of the sample is determined based on a potential difference measured between the active sensor and the reference sensor when the reference sensor and the active sensor are electrically coupled to a reader.

28. The sensor device of claim 27, wherein the active electrode layer is a platinum layer.

29. The sensor device of claim 27, wherein the conductive layer is a gold layer.

30. The sensor device of claim 27, wherein the active electrode layer has an active electrode layer thickness of at least 50 nm.

31. The sensor device of claim 27, wherein the active sensor is a rectangular piece having a width dimension of between about 100 μ ι η to 6.0mm and a length dimension of between about 100 μ ι η to 6.0 mm.

32. The sensor device of claim 27, wherein the through-hole has a diameter of between about 10 μ ι η to 100 μ ι η.

33. The sensor device of claim 27, wherein the conductive coating covering lateral sides of the via is a platinum coating.

34. The sensor device of claim 27, wherein the conductive coating covering lateral sides of the via is a gold coating.

35. The sensor device of claim 27, wherein the active sensor is insert molded into the chamber sidewall when the sample container is formed by injection molding.

36. The sensor device of claim 27, wherein the active sensor is press-molded into the chamber sidewall after the sample container is formed by injection molding.

37. The sensor device of claim 27, wherein the chamber sidewall includes a recessed portion defined around the window opening and along an exterior side of the chamber sidewall, and wherein the active sensor is adhered to at least a portion of the chamber sidewall within the recessed portion via an adhesive.

38. A sensor device for measuring a solution property of a sample, the sensor device comprising:

a sample container comprising a sample chamber, wherein the sample chamber comprises a chamber sidewall surrounding a chamber cavity configured to receive the sample,

a reference sensor comprising a reference electrode material and a wicking component in fluid communication with the sample chamber such that at least some of the sample is drawn by the wicking component in the direction of the reference electrode material; and

an active sensor made of a conductive pin partially covered by an active electrode layer, wherein the active sensor is coupled to at least a portion of the chamber sidewall at a window opening defined along the chamber sidewall, wherein the portion of the conductive pin covered by the active electrode layer extends into the chamber cavity to allow a sample within the chamber cavity to make fluidic contact with the active electrode layer, and wherein an end of the conductive pin not extending into the chamber cavity extends out of the chamber sidewall,

wherein the solution characteristic of the sample is determined based on a potential difference measured between the active sensor and the reference sensor when the reference sensor and the active sensor are electrically coupled to a reader.

39. The sensor device of claim 38, wherein the measured solution characteristic is oxidation-reduction potential, and wherein the active electrode layer is a platinum layer.

40. The sensor device of claim 38, wherein the conductive pin portion is made of stainless steel.

41. The sensor device of claim 38, wherein the active sensor is insert molded into the chamber sidewall when the sample container is formed by injection molding.

42. The sensor device of claim 38, wherein the active sensor is adhered to a portion of the chamber sidewall surrounding the window opening.

43. The sensor device of claim 38, wherein the conductive pin is substantially shaped as a cylinder with rounded edges.

44. The sensor device of claim 38, wherein the active electrode layer has an active electrode layer thickness of at least 50 nm.

45. A method of manufacturing a sensor device for measuring a solution property of a sample, the method comprising:

cleaning the conductive substrate by acid-base treatment;

depositing an adhesion layer on one side of the conductive substrate;

depositing an active electrode layer on the adhesion layer;

singulating the conductive substrate covered by the adhesion layer and the active electrode layer to produce an active sensor sized to cover a window opening defined along a chamber sidewall of a sample chamber; and

coupling the active sensor to at least a portion of the chamber sidewall such that no portion of the active sensor extends into a chamber cavity within the sample chamber and the active electrode layer faces the chamber cavity to allow any sample within the chamber cavity to make fluid contact with the active electrode layer through at least a portion of the chamber sidewall surrounding the window opening.

46. The method of claim 45, wherein cleaning the conductive substrate further comprises treating the conductive substrate with nitric acid and then treating the conductive substrate with ammonium hydroxide, isopropyl alcohol, or acetone.

47. The method of claim 45, wherein singulating the conductive substrate further comprises laser cutting, metal shearing, hot wire cutting, dye cutting, stamping, or sawing the conductive substrate.

48. The method of claim 45, wherein coupling the active sensor to at least a portion of the chamber sidewall of the sample chamber further comprises:

applying bead of adhesive to a portion of the chamber sidewall within a recess defined along the chamber sidewall around the window opening;

pressing the active sensor onto the bead of adhesive within the recessed portion; and

curing the adhesive.

49. The method of claim 45, wherein coupling the active sensor to at least a portion of the chamber sidewall of the sample chamber further comprises insert molding the active sensor into the chamber sidewall when the sample chamber is formed by injection molding.

50. The method of claim 45, wherein coupling the active sensor to at least a portion of the chamber sidewall of the sample chamber further comprises:

locally melting a portion of the chamber sidewall surrounding the window opening;

pressing the active sensor against the melted portion of the chamber sidewall; and

allowing the melted portion of the chamber sidewall to cool to secure the active sensor to the chamber sidewall.

51. The method of claim 45, wherein depositing the active electrode layer comprises depositing an active electrode material that makes up the active electrode layer until the active electrode layer is at least 50nm thick.

52. The method of claim 51, wherein the active electrode material is platinum when the solution characteristic measured is an Oxidation Reduction Potential (ORP) of the sample.

53. The method of claim 45, wherein depositing the active electrode layer comprises depositing an active electrode material making up the active electrode layer using sputter deposition, evaporation deposition, electrodeposition, or ink screen printing.

54. The method of claim 53, wherein depositing the adhesion layer comprises depositing an adhesion material comprising the adhesion layer using sputter deposition.

55. The method of claim 54, wherein the adhesion layer is deposited first in a vacuum chamber and then the active electrode layer is deposited in the vacuum chamber.

56. The method of claim 51, wherein the active electrode material is a metal oxide when the solution property measured is the pH of the sample.

57. The method of claim 56, wherein the metal oxide is platinum oxide and the platinum oxide covers a layer of platinum deposited on the adhesion layer.

58. A method of manufacturing a sensor device for measuring a solution property of a sample, the method comprising:

providing a non-conductive Printed Circuit Board (PCB) substrate;

depositing an active electrode layer on one side of the PCB substrate, wherein, after the depositing step, the active electrode layer is electrically coupled to a conductive contact of the PCB substrate by a conductive via extending through the PCB substrate;

singulating the PCB substrate covered by the active electrode layer to produce an active sensor sized to cover a window opening defined along a chamber sidewall of a sample chamber, and wherein the active sensor includes at least one conductive via extending through the PCB substrate; and

coupling the active sensor to at least a portion of the chamber sidewall such that no portion of the active sensor extends into a chamber cavity within the sample chamber and the active electrode layer faces the chamber cavity to allow any sample within the chamber cavity to make fluid contact with the active electrode layer through at least a portion of the chamber sidewall surrounding the window opening.

59. The method of claim 58, wherein depositing the active electrode layer comprises depositing active electrode material making up the active electrode layer using sputter deposition, evaporation deposition, and electrodeposition.

60. The method of claim 58, wherein depositing the active electrode layer comprises depositing an active electrode material that makes up the active electrode layer until the active electrode layer is at least 50nm thick.

61. The method of claim 59, wherein when the solution characteristic measured is the Oxidation Reduction Potential (ORP) of the sample, the active electrode material is platinum or gold.

62. The method of claim 61, wherein the conductive contact portion is made of gold.

63. The method of claim 58, wherein coupling the active sensor to at least a portion of the chamber sidewall of the sample chamber further comprises:

applying bead of adhesive to a portion of the chamber sidewall within a recess defined along the chamber sidewall around the window opening;

pressing the active sensor onto the bead of adhesive within the recessed portion; and

curing the adhesive.

64. The method of claim 58, wherein coupling the active sensor to at least a portion of the chamber sidewall of the sample chamber further comprises insert molding the active sensor into the chamber sidewall when the sample chamber is formed by injection molding.

65. The method of claim 58, wherein coupling the active sensor to at least a portion of the chamber sidewall of the sample chamber further comprises:

locally melting a portion of the chamber sidewall surrounding the window opening;

pressing the active sensor onto the melted portion of the chamber sidewall; and

allowing the melted portion of the chamber sidewall to cool to secure the active sensor to the chamber sidewall.

66. A method of manufacturing a sensor device for measuring a solution property of a sample, the method comprising:

providing a non-conductive polymer substrate comprising a plurality of vias;

depositing a conductive layer on one side of the polymer substrate;

depositing an active electrode layer on the other side of the polymer substrate, wherein one end of the via is covered by the active electrode layer and the other end of the via is covered by the conductive layer, wherein, after the depositing step, the active electrode layer is electrically coupled to the conductive layer via a conductive coating covering a lateral side of the via;

singulating the polymer substrate covered by the active electrode layer and the conductive layer to produce an active sensor sized to cover a window opening defined along a chamber sidewall of a sample chamber, wherein the active sensor comprises at least one via covered by the active electrode layer and the conductive layer; and

coupling the active sensor to at least a portion of the chamber sidewall such that no portion of the active sensor extends into a chamber cavity within the sample chamber and the active electrode layer faces the chamber cavity to allow any sample within the chamber cavity to make fluid contact with the active electrode layer through at least a portion of the chamber sidewall surrounding the window opening.

67. The method of claim 66, wherein depositing the active electrode layer comprises depositing active electrode material making up the active electrode layer using sputter deposition, evaporation deposition, and electrodeposition.

68. The method of claim 66, wherein depositing the active electrode layer comprises depositing an active electrode material comprising the active electrode layer until the active electrode layer is at least 50nm thick.

69. The method of claim 67, wherein the active electrode material is platinum when the solution characteristic measured is an oxidation-reduction potential (ORP) of the sample.

70. The method of claim 66, wherein depositing the electrical conductor comprises depositing an electrically conductive material on the other side of the polymer substrate.

71. The method of claim 70, wherein the conductive material is gold.

72. The method of claim 66, wherein coupling the active sensor to at least a portion of the chamber sidewall of the sample chamber further comprises:

applying a bead of adhesive to a portion of the chamber sidewall within a recess defined along the chamber sidewall around the window opening;

pressing the active sensor onto the bead of adhesive within the recessed portion; and

curing the adhesive.

73. The method of claim 66, wherein coupling the active sensor to at least a portion of the chamber sidewall of the sample chamber further comprises insert molding the active sensor into the chamber sidewall when the sample chamber is formed by injection molding.

74. The method of claim 66, wherein coupling the active sensor to at least a portion of the chamber sidewall of the sample chamber further comprises:

locally melting a portion of the chamber sidewall surrounding the window opening;

pressing the active sensor against the melted portion of the chamber sidewall; and

allowing the melted portion of the chamber sidewall to cool to secure the active sensor to the chamber sidewall.

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